Rotary cutting biopsy needle and biopsy system having ablation function

Abstract

The present invention provides a rotary cutting biopsy needle and a biopsy system having an ablation function. The rotary cutting biopsy needle comprises a distal pipeline portion and a proximal handheld portion. The distal pipeline portion comprises an outer sheath tube, a puncture needle tube, and a rotary cutter tube which are movably sleeved in sequence from outside to inside. The proximal handheld portion comprises a proximal housing and a puncture depth adjustment mechanism, wherein the puncture depth adjustment mechanism comprises a sheath base and a sheath base locking member. The sheath base is of a sleeve structure, and the distal end of the sheath base is fixedly sheathed on the proximal end of the outer sheath tube. The proximal end of the puncture needle tube passes through the sheath base into the proximal housing, and the proximal housing is axially movable relative to the sheath base and locked to the sheath base by means of the sheath base locking member. A conductive patch is arranged within the sheath base, and the conductive patch is in direct contact with the puncture needle tube. The sheath base is provided with a high-frequency connecting port, which is connected to the conductive patch. During ablation, the distal end of the puncture needle tube extends from the distal end of the outer sheath tube into the tissue, serving as a transmitting electrode.

Description

A rotational biopsy needle with ablation function and a biopsy system TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a rotational biopsy needle with ablation function and a biopsy system. BACKGROUND

[0002] Cancer has become a focus of social attention in recent years due to its high mortality and morbidity. With the progress of medicine, there are more and more treatment methods for cancer, and the survival period of patients is gradually prolonged. Among them, respiratory intervention therapy is one of the minimally invasive treatment techniques that have been valued in recent years, especially the interventional therapy under bronchoscopy, which has become an indispensable diagnosis and treatment method for airway and lung diseases.

[0003] Tumor ablation has the advantages of fast heating, short operation time and large ablation range, and is more and more widely used. Its intervention method is usually to enter the lesion through skin puncture under the guidance of medical imaging or to enter the lesion through bronchoscopy image, and to kill the cancer cells in the lesion site by the heat generated by the front end of the ablation electrode, so as to inhibit the growth of the tumor and achieve the effect of reducing the tumor, thereby preventing the continuous growth of the tumor and prolonging the survival time of the patient.

[0004] Before the ablation operation, biopsy sampling examination of the lesion is usually needed by using a biopsy needle, and endoscopic ultrasound-guided transbronchial needle aspiration biopsy is a minimally invasive examination technique for puncture biopsy of lung, peripulmonary tissue and lymph nodes under real-time ultrasound guidance. Its advantages are that it can avoid important parts such as large blood vessels and nerves as much as possible under real-time ultrasound monitoring, reduce the risk of massive bleeding, improve the accuracy of sampling, and is minimally invasive, simple to operate and relatively safe.

[0005] The existing biopsy needle only has the function of sampling, and cannot stop bleeding of the bleeding tissue during sampling, and also cannot ablate the lesion tissue after sampling, so that ablation operation can only be performed by other devices or equipment, which is complicated and high in cost.

[0006] SUMMARY

[0007] To solve the above technical problems, an embodiment of the present application provides a rotational biopsy needle with ablation function, which comprises a distal pipeline part and a proximal handheld part, the distal pipeline part comprises an outer sheath tube, a puncture needle tube and a rotary cutter tube which are sequentially movably sleeved from outside to inside.

[0008] The proximal handheld part comprises a proximal shell and a puncture depth adjusting mechanism, the puncture depth adjusting mechanism comprises a sheath seat and a sheath seat locking member, the sheath seat is a sleeve structure, the distal end of which is fixedly sleeved on the proximal end of the outer sheath tube, the proximal end of the puncture needle tube passes through the sheath seat into the proximal shell, the proximal shell is axially movable relative to the sheath seat and is locked with the sheath seat through the sheath seat locking member;

[0009] A conductive patch is arranged in the sheath seat, the conductive patch is in direct contact with the puncture needle tube, a high-frequency connecting port is arranged on the sheath seat, and the high-frequency connecting port is connected with the conductive patch; during ablation, the distal end of the puncture needle tube extends out of the distal end of the outer sheath tube into the tissue to serve as a transmitting electrode.

[0010] Optionally, the outer sheath tube is made of a high-molecular insulating material.

[0011] Optionally, the conductive patch is a metal spring piece, one end of the metal spring piece is fixed in the sheath seat.

[0012] Optionally, the proximal handheld part further comprises a puncture needle tube adjusting mechanism and a rotary cutter tube transmission assembly, the puncture needle tube is installed in the proximal shell through the puncture needle tube adjusting mechanism, and the puncture needle tube is axially moved by driving the puncture needle tube adjusting mechanism; the rotary cutter tube is installed in the proximal shell through the rotary cutter tube transmission assembly, and the rotary cutter tube is circumferentially rotated and axially moved by driving the rotary cutter tube transmission assembly.

[0013] Before puncture, the distal end of the puncture needle tube is located in the outer sheath tube, and the distal end of the rotary cutter tube is located in the puncture needle tube; during puncture, the sheath seat locking member does not lock the sheath seat and the proximal shell, the proximal shell drives the puncture needle tube and the rotary cutter tube to pass out of the distal end of the outer sheath tube and puncture the tissue by pushing the proximal shell to the distal end, and the distal end of the rotary cutter tube is always located in the puncture needle tube in the process of puncture; after puncture is completed, the rotary cutter tube extends out of the distal end of the puncture needle tube to rotary cut and sample the tissue; after sampling is completed, the rotary cutter tube is withdrawn, the distal end of the puncture needle tube extends out of the distal end of the outer sheath tube to ablate the tissue.

[0014] Optionally, the puncture needle tube adjusting mechanism comprises a puncture needle tube sleeve and an elastic clamping structure, the puncture needle tube sleeve is located in the proximal end shell and fixedly sheathed on the puncture needle tube, at least one side of the puncture needle tube sleeve is provided with the elastic clamping structure, at least one side of the tube wall of the proximal end shell is axially provided with a puncture needle tube adjusting slot, and the elastic clamping structure penetrates through the puncture needle tube adjusting slot; the elastic clamping structure comprises a key and at least one limiting column which are integrally arranged, and a plurality of limiting clamping grooves are arranged at intervals on at least one side groove wall of the puncture needle tube adjusting slot; in a natural state, the limiting column is located in the limiting clamping groove, the limiting column is separated from the limiting clamping groove into the proximal end shell by pressing the key, and then the puncture needle tube can move axially along the puncture needle tube adjusting slot following the key.

[0015] Optionally, a mounting hole is axially arranged at the center of the puncture needle tube sleeve, the puncture needle tube penetrates through the mounting hole and is fixed with the mounting hole, a hollow area is arranged at the proximal end of at least one side tube wall of the puncture needle tube sleeve located at the mounting hole, an elastic pressing strip is arranged at the outside of the hollow area, the elastic pressing strip is arranged along the axial direction of the puncture needle tube sleeve, the distal end of the elastic pressing strip is fixedly connected with the puncture needle tube sleeve, and the elastic clamping structure is fixed at the proximal end of the elastic pressing strip; the limiting column moves to the hollow area following the proximal end of the elastic pressing strip by pressing the key, so that the limiting column is separated from the limiting clamping groove.

[0016] Optionally, the rotary cutting knife tube transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism, the rotary cutting knife tube is driven to rotate by driving the circumferential rotation transmission mechanism, so that the rotary cutting knife tube cuts the tissue, and the rotary cutting knife tube is driven to move axially by driving the axial movement transmission mechanism, so as to adjust the cutting depth of the rotary cutting knife tube.

[0017] Optionally, the circumferential rotation transmission mechanism comprises a mandrel assembly and a rotary shaft, the mandrel assembly is fixedly sheathed on the rotary cutting knife tube, the rotary shaft is sheathed on the mandrel assembly and is axially slidably connected with the mandrel assembly and circumferentially fixedly connected with the mandrel assembly, a rotary gear is coaxially fixedly connected on the rotary shaft, the rotary gear is driven by a rotary drive motor, so that the rotary gear drives the rotary shaft to rotate.

[0018] The axial movement transmission mechanism comprises a screw sleeve and a transmission screw, the screw sleeve is rotationally arranged in the proximal end shell and is in threaded engagement with the transmission screw; the screw sleeve is coaxially fixedly connected with a stroke gear, the stroke gear is driven to rotate by a stroke drive motor, the stroke gear drives the screw sleeve to rotate, and the rotary motion of the screw sleeve is converted into the axial movement of the transmission screw.

[0019] The transmission screw sleeve is sleeved on the rotating shaft and is axially fixed and circumferentially rotatably connected with the mandrel assembly.

[0020] Optionally, the mandrel assembly comprises a fixing tube and an inner cutter sleeve, the fixing tube fixes the sleeve on the rotary cutter tube, the inner cutter sleeve fixes the sleeve on the fixing tube, the rotating shaft is sleeved on the inner cutter sleeve, and the rotating shaft and the inner cutter sleeve are axially slidably connected through the axial protrusion inserted into the axial guide groove and circumferentially fixedly connected.

[0021] The inner cutter sleeve and the transmission screw are circumferentially rotatably connected and axially fixedly connected through the annular limiting clamping piece inserted into the annular limiting clamping groove.

[0022] Optionally, the inner wall of the proximal end shell is further provided with a guide rail, and the transmission screw is slidably arranged on the guide rail.

[0023] Optionally, the outer sheath is further provided with an endoscope fixing member, the endoscope fixing member comprises a lock sleeve and a locking member, the lock sleeve comprises an integrated connecting part and a locking part, the connecting part is used for fixed connection with the endoscope, the locking part is movably sleeved on the outer sheath, and the locking part can be locked on the outer sheath through the locking member.

[0024] Optionally, the proximal end of the proximal end shell is provided with a negative pressure interface for communicating with a negative pressure device, 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 through a dynamic sealing member.

[0025] Another embodiment of the present application further provides a rotary biopsy system with ablation function, comprising the rotary biopsy needle, the negative pressure electrode and the host computer in the above-mentioned embodiments, in the ablation, the high-frequency connection port is electrically connected with the host computer through the first connecting line, the negative pressure electrode is electrically connected with the host computer through the second connecting line, the negative pressure electrode is attached to the patient, and the transmitting electrode and the negative pressure electrode form a loop.

[0026] Optionally, the rotary biopsy system further comprises a foot switch, and the foot switch is electrically connected with the host computer.

[0027] Compared with the prior art, the technical scheme of the embodiment of the present application has the following beneficial effects:

[0028] 1. The rotary biopsy needle and the rotary biopsy system provided by the present application can not only rotate and cut samples, but also ablate the lesion tissue after sampling.

[0029] 2、The present application opens a negative pressure interface at the proximal end of the proximal end shell of the biopsy needle, the negative pressure interface is in sealed communication with a connecting sleeve, the connecting sleeve is arranged in the proximal end shell, the rotary cutting knife tube is inserted into the connecting sleeve, and dynamic sealing is achieved between the rotary cutting knife tube and the connecting sleeve through a dynamic sealing element, so that the sealing problem of the rotary cutting knife tube is solved, and negative pressure suction of the rotary biopsy needle is realized.

[0030] 3、In the present application, the distal end pipeline part comprises, from the outside to the inside, an outer sheath tube, a puncture needle tube and a rotary cutting knife 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 taken out from the distal end of the outer sheath tube 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 puncture, the rotary cutting knife tube is taken out from the distal end of the puncture needle tube to sample the tissue by rotary cutting. Since the distal end of the rotary cutting knife tube is located in the puncture needle tube during puncture, the rotary cutting knife tube can enter the human tissue together with the puncture needle tube, ensuring the smoothness of the outer surface of the puncture needle tube and making it easier to puncture and break through.

[0031] 4、In the present application, the outer sheath tube is the outermost layer of the distal end pipeline part of the biopsy needle, and its inner cavity can completely accommodate the puncture needle tube and the rotary cutting knife tube, so that before puncture, the distal end of the puncture needle tube is placed in the outer sheath tube, and the distal end of the rotary cutting knife tube is placed in the puncture needle tube, and during the transportation of the outer sheath tube into the working channel of the endoscope, the puncture needle or the rotary cutting knife is prevented from damaging the endoscope.

[0032] 5、Negative pressure suction can improve the sampling amount of the rotary cutting knife tube. During sampling, as the tissue in the inner cavity of the rotary cutting knife tube increases, the friction between the tissue and the rotary cutting knife tube will increase, and the friction resistance will affect the sample tissue entering the deep part of the inner cavity of the rotary cutting knife tube, thereby causing the obtained sample tissue to be unable to increase. The suction force provided by the negative pressure can overcome the friction resistance and suck more sample tissue into the inner cavity of the rotary cutting knife, thereby improving the sampling amount.

[0033] 6、Traditional biopsy needles are usually fixed by the proximal end shell and the endoscope and are uniformly operated by the endoscope operator. However, the rotary biopsy needle has a motor, and the weight of the motor handle and the proximal end shell after assembly is relatively large. If the traditional fixing method is adopted, after the proximal end shell is fixed with the endoscope, the operation difficulty of the endoscope operator will be greatly increased. In the present application, the endoscope is directly fixed with the outer sheath tube through the endoscope fixing part on the outer sheath tube, and the proximal end shell and the motor handle are held and operated by another special operator. Therefore, the holding and operation of the endoscope are separated from the holding and operation of the proximal end shell, the operation difficulty is reduced, and the adjustment range of the intervention depth of the outer sheath tube is increased.

[0034] Of course, implementing any product of the application does not necessarily require achieving all the advantages described above at the same time. BRIEF DESCRIPTION OF DRAWINGS

[0035] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the drawings needed to be used in the embodiments or the prior art description will be briefly introduced. Obviously, the drawings in the following description only constitute some embodiments of the present application, and for those skilled in the art, other drawings can also be obtained without creative labor.

[0036] Fig. 1 is a structural schematic diagram of a rotary biopsy needle provided by an embodiment of the present application;

[0037] Fig. 2 is a structural schematic diagram of a distal end pipeline part provided by an embodiment of the present application;

[0038] Fig. 3 is a structural schematic diagram of a rotary biopsy needle provided by an embodiment of the present application (without installing a motor handle);

[0039] Fig. 4 is a sectional view of Fig. 3;

[0040] Fig. 5 is a structural schematic diagram of a rotary biopsy needle before puncture provided by an embodiment of the present application;

[0041] Fig. 6 is a structural schematic diagram of a rotary biopsy needle after puncture completion provided by an embodiment of the present application;

[0042] Fig. 7 is a structural schematic diagram of an endoscope fixing part provided by an embodiment of the present application;

[0043] Fig. 8 is an axial view of a puncture needle tube adjusting mechanism provided by an embodiment of the present application;

[0044] Fig. 9 is an end view of the puncture needle tube adjusting mechanism provided by an embodiment of the present application;

[0045] Fig. 10 is a structural schematic diagram of a rotary cutter tube with an outer blade cutting edge provided by an embodiment of the present application;

[0046] Fig. 11 is a structural schematic diagram of a rotary cutter tube with an inner blade cutting edge provided by an embodiment of the present application;

[0047] Fig. 12 is a structural schematic diagram of a rotary cutter tube provided by an embodiment of the present application;

[0048] Fig. 13 is a structural schematic diagram of a rotary cutter tube transmission assembly provided by an embodiment of the present application;

[0049] Fig. 14 is a position schematic diagram of an outer sheath tube, a puncture needle tube and a rotary cutter tube before puncture provided by an embodiment of the present application;

[0050] Figure 15 is a schematic diagram of the positions of the outer sheath tube, the puncture needle tube and the rotary cutting knife tube during puncture according to an embodiment of the present application;

[0051] Figure 16 is a schematic diagram of the positions of the outer sheath tube, the puncture needle tube and the rotary cutting knife tube during sampling according to an embodiment of the present application;

[0052] Figure 17 is a schematic diagram of the positions of the outer sheath tube, the puncture needle tube and the rotary cutting knife tube during ablation according to an embodiment of the present application. DETAILED DESCRIPTION

[0053] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0054] The terms "first", "second", "third", "fourth" and the like (if any) in the description, claims and drawings of the present application are used to distinguish similar objects, and do not necessarily indicate a specific order or sequence. It should be understood that the data thus used can be interchanged under appropriate circumstances, so that the embodiments of the present application described herein can be implemented in other than the order illustrated or described herein. In addition, the terms "comprise" and "have" and any variations thereof are intended to cover non-exclusive inclusion, for example, a process, method, system, product or device comprising a series of steps or units does not necessarily limit to those steps or units clearly listed, but can include other steps or units not clearly listed or inherent to the process, method, product or device. The terms "on" and "above" and any variations thereof are intended to describe the positional relationship, and do not represent the relationship between the objects in direct contact.

[0055] The existing biopsy needle only has a sampling function, and cannot stop bleeding of the bleeding tissue during sampling, and cannot ablate the lesion tissue after sampling.

[0056] To solve the above technical problems, the present application provides a rotary cutting biopsy needle with ablation function, comprising a distal end tube part and a proximal end handheld part, the distal end tube part is sequentially movably sleeved from outside to inside including an outer sheath tube, a puncture needle tube and a rotary cutting knife tube;

[0057] The proximal handheld part comprises a proximal shell and a puncture depth adjusting mechanism, the puncture depth adjusting mechanism comprises a sheath seat and a sheath seat locking piece, the sheath seat is a sleeve structure, the distal end of the sheath seat is fixedly sleeved on the proximal end of the outer sheath tube, the proximal end of the puncture needle tube passes through the sheath seat into the proximal shell, the proximal shell can be axially moved relative to the sheath seat, and the proximal shell is locked with the sheath seat through the sheath seat locking piece.

[0058] The sheath seat is provided with a conductive patch, the conductive patch is in direct contact with the puncture needle tube, the sheath seat is provided with a high-frequency connecting port, and the high-frequency connecting port is connected with the conductive patch; during ablation, the distal end of the puncture needle tube is stretched out from the distal end of the outer sheath tube into the tissue and serves as a transmitting electrode.

[0059] Further, the application also provides a rotary biopsy system with ablation function, comprising the rotary biopsy needle, the negative pressure electrode and the host computer, during ablation, the distal end of the puncture needle tube is stretched out from the distal end of the outer sheath tube into the tissue and serves as a transmitting electrode, the high-frequency connecting port is electrically connected with the host computer through a first connecting line, the negative pressure electrode is electrically connected with the host computer through a second connecting line, the negative pressure electrode is attached to the patient, and the transmitting electrode and the negative pressure electrode form a loop.

[0060] The application does not limit the application site of the rotary biopsy needle, therefore, the application does not limit the specific site of the negative pressure electrode attached to the patient, and the specific use requirement can be set according to the specific use requirement.

[0061] In order to facilitate the operation of the operator, the rotary biopsy system further comprises a foot switch, the foot switch is electrically connected with the host computer and is used for controlling the switch of ablation.

[0062] The rotary biopsy needle and the rotary biopsy system provided by the application can not only rotate and cut for sampling, but also can ablate the lesion tissue after sampling.

[0063] In order to make the above-mentioned purposes, features and advantages of the application more obvious and easy to understand, the technical solutions in the embodiments of the application will be clearly and completely described below in combination with the drawings in the embodiments of the application. Obviously, the described embodiments are only part of the embodiments of the application, rather than all the embodiments. Based on the embodiments in the application, all other embodiments obtained by those skilled in the art without creative labor are within the protection scope of the application.

[0064] Please refer to Fig. 1 to Fig. 4, the present application provides a kind of rotary biopsy needle, including distal end pipeline portion 1 and proximal hand-held portion, the distal end pipeline portion 1 includes outer sheath tube 101, puncture needle tube 102 and rotary cutter tube 103 from outside to inside in turn active cover set.

[0065] Proximal hand-held portion includes proximal end shell 4, puncture depth adjustment mechanism 3, puncture needle tube adjustment mechanism 6 and rotary cutter tube transmission assembly 7, please refer to Fig. 3, the puncture depth adjustment mechanism 3 includes sheath seat 301 and sheath seat locking piece 302, the sheath seat 301 is sleeve structure, its distal end is fixed outer cover in the proximal end of the outer sheath tube 101.The proximal end of the puncture needle tube 102 and rotary cutter tube 103 all pass through the sheath seat 301 to the proximal end shell 4 inside.The puncture needle tube 102 is installed in the proximal end shell 4 by the puncture needle tube adjustment mechanism 6, by driving the puncture needle tube adjustment mechanism 6, so that the puncture needle tube moves axially;The rotary cutter tube 103 is installed in the proximal end shell 4 by the rotary cutter tube transmission assembly 7, by driving the rotary cutter tube transmission assembly 7, so that the rotary cutter tube 103 does circumferential rotation and axial movement.The proximal end shell 4 can be axially moved relative to sheath seat 301, the sheath seat 301 can be locked with the proximal end shell 4 by the sheath seat locking piece 302.

[0066] The sheath seat 301 is provided with a conductive patch 304, the conductive patch 304 is in direct contact with the puncture needle tube 102, and the sheath seat 301 is provided with a high-frequency connection port 303, and the high-frequency connection port 303 is connected with the conductive patch 304.

[0067] The shape and specific structure of the conductive patch 304 are not limited, as long as it can be in direct contact with the puncture needle tube 102 at all times, and the purpose is to electrically connect the puncture needle tube 102 with the host computer through the high-frequency connection port 303.

[0068] As an embodiment, the conductive patch 304 is a metal spring, one end of the metal spring is fixed in the sheath seat 301, and the metal spring is always in direct contact with the puncture needle tube 102 through the elastic force of the metal spring. The outer sheath tube 101 is made of high molecular insulating material, and the purpose is to use the needle of the puncture needle tube 102 (i.e. the distal end of the puncture needle tube 102) which is inserted into the target tissue as a transmitting electrode when ablation, and the tissue is ablated, which also has the effect of hemostasis.

[0069] 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 lock 302 does not lock the sheath seat 301 and the proximal end shell 4, the puncture needle tube 102 and the rotary cutter tube 103 are pushed to the distal end together to puncture the tissue from the distal end of the outer sheath tube 101, 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 is stretched out from the distal end of the puncture needle tube 102 to sample the tissue by rotary cutting; after the sampling is completed, the puncture needle tube 102 is retracted to stretch out the needle from the distal end of the outer sheath tube 101 to ablate the tissue.

[0070] Since the distal end of the rotary cutter tube 103 is located in the puncture needle tube 102 during puncture, the rotary cutter tube 103 can follow the puncture needle tube 102 to penetrate into the human tissue, which ensures the smoothness of the outer surface of the puncture needle tube 102 and makes it easier to puncture and break through.

[0071] In the present application, the outer sheath tube 101 is the outermost layer of the distal end tube part of the biopsy needle, and its inner cavity can completely accommodate the puncture needle tube 102 and the rotary cutter tube 103, so that before puncture, the distal end of the puncture needle tube 102 is placed in the outer sheath tube 101, and the distal end of the rotary cutter tube 103 is placed in the puncture needle tube 102, and during the transportation of the outer sheath tube 101 into the working channel of the endoscope, the puncture needle or the rotary cutter is prevented from damaging the endoscope.

[0072] The material of the outer sheath tube 101 is not limited in the present application, and is preferably a smooth high-molecular insulating material such as PTFE or PEEK, which prevents the endoscope from being damaged during the transportation through the working channel of the endoscope and ensures the transportation performance. In addition, during ablation, the part of the puncture needle tube 102 except the needle part is insulated to prevent the endoscope and other human tissues from being damaged.

[0073] The conventional biopsy needle is usually fixed by the proximal end shell and the endoscope and is uniformly operated by the endoscope operator. However, the rotary biopsy needle has a motor, and the weight of the motor handle and the proximal end shell is large after assembly, so if the conventional fixing method is adopted, the fixation of the proximal end shell and the endoscope will greatly increase the difficulty of the endoscope operation and the operation difficulty of the endoscope operator.

[0074] In order to solve the above technical problems, the endoscope fixing member 2 on the outer sheath tube 101 is used to directly fix the outer sheath tube 101 and the endoscope, and the proximal end shell and the motor handle are held and operated by another special operator. Therefore, the holding and operation of the endoscope and the holding and operation of the proximal end shell are separated, the operation difficulty is reduced, and the adjustment range of the intervention depth of the outer sheath tube 101 is increased.

[0075] As an embodiment, please refer to Fig. 7, the endoscope fixing member 2 comprises a locking member 202 and a locking sleeve 201, the locking sleeve 201 is provided with a connecting part 2011 fixedly connected with the endoscope and a locking part 2013 movably sleeved on the outer sheath 101, the locking part 2013 is axially movable relative to the outer sheath 101, and the locking part 2013 is locked on the outer sheath 101 by the locking member 202.

[0076] The embodiment does not make specific limitation on the fixed connection mode of the connecting part 2011 and the endoscope, such as threaded connection, clamping or other detachable fixed connection mode. Meanwhile, the embodiment does not make specific limitation on the mode of locking the locking part 2013 on the outer sheath 101 by the locking member 202, such as nut locking, locking screw locking and the like.

[0077] As an embodiment, the connecting part 2011 is a first luer joint, the proximal end of the working channel of the endoscope is provided with a second luer joint matched with the first luer joint, and the first luer joint is connected with the second luer joint in a matched mode.

[0078] In a specific embodiment, the connecting part 2011 and the locking part 2013 are coaxially fixedly connected through an intermediate connecting sleeve 2012, the connecting part 2011 and the intermediate connecting sleeve 2012 are movably sleeved on the outer sheath 101, the connecting part 2011 is located at the distal end of the intermediate connecting sleeve 2012, an internal thread joint is formed on the connecting part 2011, the proximal end of the working channel of the endoscope is provided with an external thread joint matched with the internal thread joint, and the internal thread joint and the external thread joint are fastened in a threaded mode; the locking part 2013 is located at the proximal end of the intermediate connecting sleeve 2012, the locking part 2013 is provided with an external thread, the locking member 202 is a first lock cap, a threaded hole matched with the external thread of the locking part 2013 is formed in the first lock cap, and the first lock cap is screwed on the locking part 2013, so that the locking part 2013 clamps the outer sheath 101.

[0079] The locking part 2013 can be an elastic member such as a silica gel structure, and the first lock cap enhances the fixing effect by extruding the elastic member. The proximal end of the locking part 2013 can also be provided with a plurality of pressing strips movably sleeved on the outer sheath 101, the first lock cap is designed into a tapered structure gradually tapering from the distal end to the proximal end, the first lock cap is screwed with the locking part 2013, so that the plurality of pressing strips are folded and clamp the outer sheath 101, thereby realizing the fixed connection of the outer sheath 101 and the endoscope.

[0080] In the delivery, the endoscope is fixedly connected with the connecting part 2011, and the first lock cap is in the loosened state, so that the endoscope can be moved at will 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 lock cap is locked, so that the locking part 2013 is locked and shrunk to clamp the outer sheath tube 101, thereby realizing the fixation of the outer sheath tube 101 and the endoscope.

[0081] Since the locking part 2013 can move axially relative to the outer sheath tube 101, the endoscope fixing part 2 can realize locking at any position of the outer sheath tube 101, thereby expanding the adjustment range of the intervention length of the outer sheath tube 101.

[0082] Since the technical scheme of adjusting and locking between two components by the locking part 202 cooperating with the lock sleeve 201 belongs to a relatively mature technology in the mechanical field, any technical scheme of adjusting and locking between the outer sheath tube 101 and the endoscope by the locking part 202 cooperating with the lock sleeve 201 is within the protection scope of the present application.

[0083] Similarly, since the sheath seat 301 and the sheath seat locking part 302 of the puncture depth adjustment mechanism 3 also realize the technical scheme of adjusting and locking between two components by cooperation, this technical scheme belongs to a relatively mature technology in the mechanical field, and therefore the present application does not limit the specific structure of the sheath seat 301 and the sheath seat locking part 302. Any technical scheme of adjusting and locking between the outer sheath tube 101 and the proximal shell 4 by the sheath seat 301 cooperating with the sheath seat locking part 302 is within the protection scope of the present application.

[0084] As an embodiment, the sheath seat 301 is a sleeve structure, the distal end of the sheath seat 301 is fixedly connected coaxially with the proximal end of the outer sheath tube 101, and the proximal end of the sheath seat 301 movably sheaths the proximal shell 4. An outer thread is arranged on the proximal outer wall of the sheath seat 301, the sheath seat locking part 302 is a second lock cap, a threaded hole matched with the outer thread of the sheath seat 301 is arranged in the second lock cap, and the sheath seat 301 clamps the proximal shell 4 by screwing the second lock cap on the sheath seat 301.

[0085] The proximal end of the sheath seat 301 can be an elastic member such as a silica gel structure, and the second lock cap can enhance the fixing effect by extruding the elastic member. The proximal end of the sheath seat 301 is not limited to an elastic member, and a plurality of pressing strips can be arranged at intervals and movably sheath the proximal shell 4. The second lock cap is designed to be a tapered structure that gradually narrows from the distal end to the proximal end, and the plurality of pressing strips are clamped and fixed to the proximal shell 4 by screwing the second lock cap on the sheath seat 301, thereby realizing the locking connection between the sheath seat 301 and the proximal shell 4.

[0086] In the initial state before puncture, the distal end of the puncture needle tube 102 is located in the outer sheath tube 101, the distal end of the rotary cutter tube 103 is located in the puncture needle tube 102, and the outer sheath tube 101 is delivered into the working channel of the endoscope. When the outer sheath tube 101 reaches the designated position and is fixed, puncture breakthrough can be performed, at which time the puncture depth adjusting mechanism 3 is adjusted according to the requirement of puncture depth, specifically, the second lock cap is loosened, the sheath seat 301 is held by hand, the proximal end shell 4 is quickly pushed to the distal end, the proximal end shell 4 will drive the distal end of the puncture needle tube 102 and the rotary cutter tube 103 to penetrate out of the outer sheath tube 101, and puncture the obstacle tissue such as the bronchial wall. After the puncture is completed, the second lock cap is locked.

[0087] When the proximal end shell 4 is quickly pushed to the distal end, in order to facilitate the hand to operate the proximal end shell 4, an annular protrusion 401 is arranged on the outside of the proximal end shell 4, and the annular protrusion 401 is pushed to achieve the purpose of quickly pushing the proximal end shell 4 to the distal end.

[0088] In order to be able to identify the puncture depth, a puncture depth scale is arranged on the proximal end shell 4.

[0089] Of course, the sheath seat locking member 302 of the present application is not limited to the lock cap structure, but can also be a threaded fastener. Specifically, a threaded hole is arranged on one side wall of the sheath seat 301, the sheath seat locking member 302 is a threaded fastener matched with the threaded hole, the first end of the threaded fastener penetrates through the threaded hole into the sheath seat, and the second end is located on the outside of the sheath seat 301. By manually tightening the second end of the threaded fastener, the first end of the threaded fastener is abutted against the proximal end shell 4, so that the proximal end shell 4 is fixed with the sheath seat 301. The threaded fastener is a lock screw or the like structure.

[0090] The puncture needle tube 102 is an intermediate layer of the distal end tube part of the biopsy needle, and is made of metal material, such as 304L, 316L stainless steel material. The thickness of the puncture needle should be as low as possible, usually <0.1 mm, to increase the inner cavity for accommodating the rotary cutter tube. The puncture needle tube 102 has a needle tip, through which puncture breakthrough can be achieved.

[0091] In order to improve the effect of ultrasonic imaging and facilitate the observation of the position of the puncture needle tube 102, a first ultrasonic reflection area is arranged on the outer surface of the puncture needle tube 102 near the needle tip 1021. The first ultrasonic reflection area requires uneven lines. As for the line shape of the first ultrasonic reflection area, the present application does not make specific limitation. For example, the roughness of the outer surface of the puncture needle tube 102 is increased by thread, dotting or other processes, so as to improve the imaging effect of the puncture needle tube 102 under ultrasonic.

[0092] In the present application, the puncture needle tube 102 is installed in the proximal shell 4 through the puncture needle tube adjusting mechanism 6, and the puncture needle tube 102 is axially moved through the puncture needle tube adjusting mechanism 6, that is, the puncture needle tube 102 can be moved to the distal end or to the proximal end through the puncture needle tube adjusting mechanism 6.

[0093] As an embodiment, referring to FIG. 8 and FIG. 9, the puncture needle tube adjusting mechanism 6 comprises a puncture needle tube sleeve 602 and an elastic clamping structure 601, the puncture needle tube sleeve 602 is located in the proximal shell 4 and is fixedly sleeved on the proximal end of the puncture needle tube 102; at least one side of the puncture needle tube sleeve 602 is provided with the elastic clamping structure 601, at least one side of the tube wall of the proximal shell 4 is axially provided with a puncture needle tube adjusting slot, and the elastic clamping structure 601 penetrates the puncture needle tube adjusting slot; the elastic clamping structure 601 comprises a button 6011 and at least one limiting column 6012 which are integrally arranged, and a plurality of limiting clamping grooves are arranged on at least one side of the puncture needle tube adjusting slot; in the natural state, the limiting column 6012 is located in the limiting clamping groove, the button 6011 is pressed to make the limiting column 6012 separate from the limiting clamping groove to the proximal shell 4, and then the puncture needle tube 102 can be axially moved along the puncture needle tube adjusting slot with the button 6011.

[0094] In this embodiment, when the button 6011 is pressed, the limiting column 6012 separates from the limiting clamping groove, the puncture needle tube 102 can be axially moved along the puncture needle tube adjusting slot with the button 6011, and the position adjustment of the puncture needle tube 102 in the axial direction is realized. After the button is released, the button is reset under the action of elasticity, the limiting column 6012 is inserted into the limiting clamping groove of the puncture needle tube adjusting slot, and the fixation of the puncture needle tube 102 is realized.

[0095] In the present application, after the puncture is completed, the puncture needle tube 102 is withdrawn through the puncture needle tube adjusting mechanism 6, so that the distal end of the rotary cutter tube 103 is stretched out from the distal end of the puncture needle, and then the rotary cutter tube 103 starts to implement the rotary cutting. Of course, the mode of making the distal end of the rotary cutter tube 103 stretch out from the distal end of the puncture needle is not limited to withdrawing the puncture needle tube 102, but also can be directly stretching out the distal end of the rotary cutter tube 103 from the distal end of the puncture needle tube 102. As an embodiment, the distal end of the rotary cutter tube 103 is stretched out from the distal end of the puncture needle tube 102 through the driving of the rotary cutter tube transmission assembly 7.

[0096] In order to identify the distance of the withdrawal of the puncture needle tube 102, an adjusting scale is arranged on the outside of the puncture needle tube adjusting slot.

[0097] In order to facilitate manual operation, preferably, an elastic clamping structure 601 is arranged on each of the two corresponding outer sides of the puncture needle tube sleeve 602, and the elastic clamping structure 601 is arranged along the radial direction of the puncture needle tube sleeve 602. A puncture needle tube adjusting groove is formed in the tube wall of the proximal end shell 4 along the axial direction on each of the two corresponding sides, and the two elastic clamping structures 601 respectively penetrate the two puncture needle tube adjusting grooves. A plurality of limiting clamping grooves are arranged on the groove walls on both sides of the puncture needle tube adjusting groove. Correspondingly, a limiting column 6012 is arranged on each of the two sides of the button 6011, and the button 6011 and the limiting columns 6012 on both sides thereof are arranged along the circumferential direction of the puncture needle tube sleeve 602. In the natural state, the limiting columns 6012 on both sides of the button 6011 are respectively located in a limiting clamping groove on the groove wall on each side of the puncture needle tube adjusting groove. When the button 6011 needs to be pressed, the operator presses the two buttons 6011 with two fingers at the same time, so that the limiting columns 6012 are separated from the limiting clamping grooves, and then the button 6011 is pushed to adjust the position of the puncture needle tube 102.

[0098] In an embodiment, the center of the puncture needle tube sleeve 602 is provided with a mounting hole 6021 along the axial direction, the puncture needle tube 102 penetrates the mounting hole 6021 and is fixed with the mounting hole 6021; the proximal end of the tube wall on at least one side of the mounting hole 6021 of the puncture needle tube sleeve 602 is provided with a hollow area 6022, the outer side of the hollow area 6022 is provided with an elastic pressing strip 6013, the elastic pressing strip 6013 is arranged along the axial direction of the puncture needle tube sleeve 602, the distal end of the elastic pressing strip 6013 is fixedly connected with the puncture needle tube sleeve 602, the elastic clamping structure 601 is fixed at the proximal end of the elastic pressing strip 6013, and pressing the button 6011 makes the limiting column 6012 move with the proximal end of the elastic pressing strip 6013 to the hollow area 6022, so that the limiting column 6012 is separated from the limiting clamping groove.

[0099] The rotary cutting knife tube 103 is a tubular structure, which is the innermost layer of the distal end tube part of the biopsy needle. The distal end of the rotary cutting knife tube 103 is provided with a ring-shaped knife edge, which ensures that the rotary cutting knife tube 103 can smoothly cut the tissue. The ring-shaped knife edge preferably adopts a flat mouth structure, which is used to ensure the integrity of the tissue after rotary cutting, so as not to be twisted and mashed, and affect the pathological analysis.

[0100] As an embodiment, referring to FIG. 10, the ring-shaped knife edge at the distal end of the rotary cutting knife tube 103 is an outer blade knife edge 1031 formed by removing the inner corner of the distal end face of the rotary cutting knife tube 103. The outer blade knife edge 1031 is used for cutting low-density tissue.

[0101] As another embodiment, please refer to FIG. 11, the annular blade at the distal end of the rotary cutter tube 103 is an inner blade edge 1031' formed by removing the outer corner of the distal end face of the rotary cutter tube 103, which is used for cutting high-density tissues.

[0102] In a specific embodiment, please refer to FIG. 12, the rotary cutter tube 103 includes a distal metal tube 1032, a metal wire spring tube 1033, a proximal metal tube 1035, and a high-molecular sealing tube 1034. The distal metal tube 1032 and the proximal metal tube 1035 are both metal tubes, such as stainless steel tubes. The distal end of the distal metal tube 1032 is an annular blade. The distal metal tube 1032 is made of metal, which can ensure that the rotary cutter tube 103 can smoothly cut tissues. The proximal metal tube 1035 is made of metal, which is convenient for assembly and fixation. The metal wire spring tube 1033 is a hollow tube woven by metal wires. The metal wires are made of stainless steel or nickel-titanium structure. The metal wire spring tube 1033 can flexibly transmit rotary speed and torque in a bent state and effectively reduce vibration. The proximal end of the distal metal tube 1032 and the distal end of the metal wire spring tube 1033 are connected by end face welding process, which ensures that the outer diameter and the inner diameter of the distal metal tube 1032 and the metal wire spring tube 1033 are basically consistent.

[0103] On the outside of the rotary cutter tube 103, there is a thin-walled high-molecular sealing tube 1034, such as a thin-walled heat shrink tube, which is fixed on the outside of the rotary cutter tube 103 by heat shrink process to realize the sealing of the rotary cutter tube 103, so that the internal cavity can transmit negative pressure or positive pressure to avoid leakage at the welding position, the gap between the woven tubes, etc. At the same time, the thin-walled heat shrink tube can reduce the friction between the rotary cutter tube and the puncture needle tube when rotating, and avoid the wear of the woven metal wires of the rotary cutter tube.

[0104] The proximal metal tube 1035 is wrapped on the proximal outside of the high-molecular sealing tube 1034, which can be fixed by bonding or other methods. In this way, a sealed tube cavity with only two outlets can be formed inside the rotary cutter tube.

[0105] As an embodiment, the metal wire spring tube 1033, the high-molecular sealing tube 1034, and the proximal metal tube 1035 are flush at the proximal end face.

[0106] In the field, in order to realize the flexible rotation of the rotary cutting knife tube 103, the torque and rotation speed of the rotary cutting knife tube 103 are realized by the flexible transmission of the rotary cutting soft shaft of the wire spring tube 1033, but the wire spring tube 1033 is very easy to vibrate in the state without rigid support, which affects the sampling effect. In the present application, the puncture needle tube 102 is sleeved outside the rotary cutting knife tube 103, and the inner diameter of the puncture needle tube 102 is slightly larger than the outer diameter of the rotary cutting knife tube 103, so that the puncture needle tube 102 can play a role similar to a sliding bearing. When the rotary cutting knife tube 103 rotates, the rotary cutting knife tube 103 rotates in the inner cavity of the puncture needle tube 102, avoiding the vibration of the rotary cutting knife tube 103, thereby providing rigid support for the rotary cutting knife tube 103 and improving the stability of the rotary cutting knife tube 103 when rotating.

[0107] The outer surface of the rotary cutting knife tube 103 is covered with a high-molecular sealing tube 1034, and the high-molecular sealing tube 1034 is at least sealed on the wire spring tube 1033 and the connection between the wire spring tube 1033 and the distal end metal tube 1032.

[0108] In order to reduce the friction between the rotary cutting knife tube 103 and the puncture needle tube 102 when rotating, and avoid the wear of the woven wire of the rotary cutting knife tube 103, the high-molecular sealing tube 1034 is a heat shrink tube formed by fixing a high-molecular tube material on the outer surface of the rotary cutting knife tube 103 through a heat shrink process. The heat shrink tube can also improve the torsional performance and sealing performance of the wire spring tube 1033 without losing the bending performance.

[0109] In order to increase the adhesion of the cut tissue and avoid the shedding of the cut and sampled tissue, the inner wall surface of the rotary cutting knife tube 103 is provided with a rough surface that increases the friction coefficient, such as a threaded surface.

[0110] In order to improve the effect of ultrasonic imaging, the outer surface of the distal end metal tube 1032 is provided with a second ultrasonic reflection area, which requires an uneven pattern. The shape of the pattern of the second ultrasonic reflection area is not specifically limited in the present application. For example, the roughness of the outer surface of the distal end metal tube 1032 is increased by thread rolling, dotting and other processes to improve the imaging effect of the rotary cutting knife tube 103 under ultrasonic.

[0111] In the present application, the rotary cutting knife tube transmission assembly 7 is installed in the proximal end shell 4, the rotary cutting knife tube transmission assembly 7 is connected with the rotary cutting knife tube 103, and the rotary cutting knife tube 103 is driven by the rotary cutting knife tube transmission assembly 7 to cut the tissue.

[0112] The rotation cutting knife tube transmission assembly 7 drives the rotation cutting knife tube 103 to rotate and cut tissues, and the axial stroke of the rotation cutting knife tube 103 can be adjusted to adjust the cutting depth of the rotation cutting knife tube 103, which is mature technology in the field, and thus the specific structure of the rotation cutting knife tube transmission assembly 7 is not limited in the application.

[0113] The rotation cutting knife tube transmission assembly 7 drives the rotation cutting knife tube 103 to rotate and cut tissues, and the axial stroke of the rotation cutting knife tube 103 can be adjusted to adjust the cutting depth of the rotation cutting knife tube 103, which is mature technology in the field, and thus the specific structure of the rotation cutting knife tube transmission assembly 7 is not limited in the application.

[0114] As an embodiment, the circumferential rotation transmission mechanism includes a mandrel assembly located in the proximal end shell 4 and a rotation shaft 702, the mandrel assembly is fixedly sleeved on the rotation cutting knife tube 103, the rotation shaft 702 is sleeved on the mandrel assembly and is axially slidably connected with the mandrel assembly and circumferentially fixedly connected with the mandrel assembly, the rotation shaft 702 is coaxially fixedly connected with a rotation gear 701, the rotation gear 701 is driven by a rotation driving motor to drive the rotation shaft 702 to rotate.

[0115] The rotation shaft 702 and the mandrel assembly are axially slidably connected and circumferentially fixedly connected, which is a conventional technical means in the mechanical field, and thus the specific connection structure of the rotation shaft 702 and the mandrel assembly is not limited in the application.

[0116] As an embodiment, the mandrel assembly includes a fixed tube 708 and an inner knife sleeve 706, the fixed tube 708 is fixedly sleeved on the rotation cutting knife tube 103, the inner knife sleeve 706 is fixedly sleeved on the fixed tube 708, the rotation shaft 702 is sleeved on the inner knife sleeve 706, and the rotation shaft 702 and the inner knife sleeve 706 are axially slidably connected and circumferentially fixedly connected by means of the protrusions axially inserted into the axial guide grooves.

[0117] In a specific implementation, the inner wall of the rotating shaft 702 is provided with a plurality of protrusions spaced apart in the circumferential direction, and the protrusions are arranged in the axial direction of the rotating shaft 702. The outer wall of the inner cutter sleeve 706 is provided with a plurality of guide grooves adapted to the protrusions and spaced apart in the circumferential direction, and the guide grooves are arranged in the axial direction of the inner cutter sleeve 706. The rotating shaft 702 and the inner cutter sleeve 706 are axially slidably connected, circumferentially fixedly connected by inserting the protrusions into the guide grooves, that is, the rotating shaft 702 and the inner cutter sleeve 706 can relatively slide in the axial direction and synchronously rotate in the circumferential direction. Of course, the protrusions can also be arranged on the outer wall of the inner cutter sleeve 706, and the guide grooves can be arranged on the inner wall of the rotating shaft 702. This embodiment does not specifically limit this.

[0118] The axial movement transmission mechanism includes a screw sleeve 703 and a transmission screw 704. The screw sleeve 703 is sleeved on the transmission screw 704 and is in threaded engagement with the transmission screw 704 for transmission. The screw sleeve 703 is coaxially fixedly connected with a stroke gear 709. The stroke gear 709 is driven to rotate by a stroke drive motor. The stroke gear 709 drives the screw sleeve 703 to rotate, and the rotation of the screw sleeve 703 is converted into the axial movement of the transmission screw 704. The transmission screw 704 is sleeved on the rotating shaft 702 and is fixedly connected with the mandrel assembly in the axial direction and relatively rotatably connected in the circumferential direction.

[0119] As an embodiment, the proximal hand-held part further includes a motor handle 5. The rotating drive motor and the stroke drive motor are both mounted in the motor handle 5, and the motor handle 5 is fixedly connected with the proximal shell 4. The rotating drive motor and the stroke drive motor directly control or control the rotating gear 701 and the stroke gear 709 through gear transmission, respectively, to realize the rotation and forward and backward movement of the rotary cutter tube 103.

[0120] The screw sleeve 703 only rotates in the proximal shell 4 and does not move axially. In order to limit the axial movement of the screw sleeve 703 in the proximal shell 4, a positioning partition plate is arranged on the proximal shell 4 at the proximal end and the distal end of the screw sleeve 703. The purpose is to limit the screw sleeve 703 between the two positioning partition plates to prevent axial movement.

[0121] In this embodiment, the transmission screw 704 is sleeved on the rotating shaft 702 and is fixedly connected with the mandrel assembly in the axial direction and relatively rotatably connected in the circumferential direction.

[0122] As an embodiment, the inner cutter sleeve 706 and the transmission screw 704 are circumferentially rotatably connected and axially fixedly connected by inserting an annular limiting clamp member arranged in the circumferential direction into an annular limiting clamp groove.

[0123] In a specific implementation, the outer side of the inner cutter sleeve 706 is circumferentially provided with an annular limiting clamping groove 7061, and the inner side of the transmission screw 704 is circumferentially provided with an annular limiting clamping piece 705 matched with the annular limiting clamping groove 7061. The annular limiting clamping piece 705 is inserted into the annular limiting clamping groove 7061 to achieve the circumferential rotation connection between the transmission screw 704 and the inner cutter sleeve 706, and the axial fixed connection, that is, the inner cutter sleeve 706 and the transmission screw 704 can rotate relative to each other, but cannot have relative displacement in the axial direction. Of course, the inner side of the transmission screw 704 can be circumferentially provided with an annular limiting clamping groove, and the outer side of the inner cutter sleeve 706 is circumferentially provided with an annular limiting clamping piece matched with the annular limiting clamping groove. The present embodiment does not specifically limit this.

[0124] An inner wall of the proximal end shell 4 is axially provided with a guide rail 8, and the transmission screw 704 is slidingly arranged on the guide rail 8. By driving the rotation of the screw sleeve 703, the transmission screw 704 moves along the guide rail 8, so as to limit the axial movement distance of the transmission screw 704.

[0125] Please refer to FIG. 13. The proximal end face of the proximal end shell 4 is provided with a negative pressure interface 401 for communicating with a negative pressure device. The proximal end of a connecting sleeve 9 in the proximal end shell 4 is in sealed communication with the negative pressure interface 401. The proximal end of the rotary cutting knife tube 103 is inserted into the connecting sleeve 9 from the distal end of the connecting sleeve 9, and the connecting sleeve 9 and the rotary cutting knife tube 103 are dynamically sealed by a dynamic sealing piece 10. When the rotary cutting knife tube 103 rotates and advances, the rotary cutting knife tube 103 moves from the proximal end to the distal end. The rotary cutting knife tube 103 always has a part of the tube segment located in the connecting sleeve 9 of the rotary cutting knife tube 103 and in contact with the dynamic sealing piece 10, forming a dynamic seal.

[0126] In the initial position, the present application does not limit the length of the rotary cutting knife tube 103 located in the connecting sleeve 9, and when the rotary cutting knife tube 103 moves from the proximal end to the distal end to the maximum cutting depth, the length of the rotary cutting knife tube 103 located in the connecting sleeve 9 is also not limited, which can be set according to the actual use requirement. In order to prevent the rotary cutting knife tube 103 from being separated from the connecting sleeve 9, as an embodiment, the size of the rotary cutting knife tube 103 in the connecting sleeve 9 is greater than 2 cm in the initial position.

[0127] Since the dynamic sealing piece 10 is a relatively mature technology in the field of mechanical fluid transmission, the present application does not limit the specific structure of the dynamic sealing piece 10.

[0128] As an embodiment, the dynamic sealing piece 10 is a sealing ring, such as a generic sealing ring or a silica gel sealing ring.

[0129] In one embodiment, the outer periphery of the sealing ring is in sealing connection with the inner periphery of the connecting sleeve 9, and the proximal end of the rotary cutter tube 103 is inserted into the sealing ring and in dynamic sealing connection with the sealing ring.

[0130] In another embodiment, the sealing ring is fixed on the distal end face of the connecting sleeve 9, and the proximal end of the rotary cutter tube 103 is inserted into the sealing ring and in dynamic sealing connection with the sealing ring, as shown in FIG. 13.

[0131] The inner surface of the dynamic sealing member 10 and the outer surface of the rotary cutter tube 103 should be as smooth as possible to reduce the frictional resistance caused by the sealing.

[0132] In order to facilitate assembly and fixation, the connecting sleeve 9 is made of a metal tube, such as a steel tube.

[0133] As an example, the negative pressure interface 401 is connected to one end of a negative pressure pipeline through a luer joint, and the other end of the negative pressure pipeline is connected to a negative pressure device. After the luer joint is screwed, the negative pressure can be transmitted from the negative pressure device to the distal end of the rotary cutter tube 103.

[0134] Since the rotary cutter tube 103 is a tubular structure with a ring-shaped blade at the distal end, after sampling is completed, the tissue at the blade edge needs to be pulled off to complete the sampling. Therefore, during sampling, the negative pressure device performs negative pressure suction on the rotary cutter tube 103 through the negative pressure interface 401, and the negative pressure suction can increase the pulling-off force of the rotary cutter tube 103 when it is retracted, thereby ensuring that the tissue can be successfully pulled off.

[0135] After sampling is completed, the syringe injects physiological saline into the rotary cutter tube 103 through the negative pressure interface 401, and the positive pressure provided by the injection of the physiological saline can flush the tissue sample out of the rotary cutter tube 103.

[0136] The negative pressure device and the syringe can share one interface, or separate interfaces can be used and connected to the negative pressure interface 401.

[0137] As an example, the negative pressure interface 401 is also connected to a three-way joint, 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 the negative pressure device, and the third interface is used to connect the syringe. An adjustment switch is arranged in the three-way joint, and the first interface can switch the communication path 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 the tissue in the rotary cutter tube 103 to achieve complete sampling of the tissue.

[0138] The specific type of negative pressure device is not limited, such as negative pressure suction needle cylinder or negative pressure pump. The following takes the negative pressure device as a negative pressure pump as an example to illustrate the method for adjusting the size of the negative pressure.

[0139] In order to realize the adjustment of the size of the negative pressure, the host also includes a host control module, which is electrically connected with the negative pressure pump through the negative pressure driving module. The host control module controls the output of the DAC analog signal and outputs the adjustable pressure driving signal. Since the driving voltage of the negative pressure pump is linearly related to the flow, the driving voltage of the negative pressure pump, i.e. the size of the negative pressure pump flow, can realize the adjustment of the size of the negative pressure.

[0140] The host also has a negative pressure sensor for monitoring the real-time negative pressure size of the negative pressure pump, feeding back the accurate negative pressure value to the host control module. The host control module adjusts the negative pressure value by adjusting the flow size of the negative pressure pump based on the feedback negative pressure value.

[0141] The working principle of the rotary biopsy needle:

[0142] Please refer to FIG. 14, before puncture, the distal end of the puncture needle tube 102 is located in the outer sheath tube 101, and the distal end of the rotary cutter tube 103 is located in the puncture needle tube 102. The outer sheath tube 101 is delivered into the working channel of the endoscope. When the outer sheath tube 101 reaches the designated position, the outer sheath tube 101 is fixed with the endoscope through the endoscope fixing part 2.

[0143] During puncture, the sheath seat locking part 302 does not lock the sheath seat 301 and the proximal end shell 4. By pushing the proximal end shell 4 to the distal end, the puncture needle tube 102 and the rotary cutter tube 103 are together out of the distal end of the outer sheath tube 101 and puncture the tissue. Please refer to FIG. 15. During puncture, the distal end of the rotary cutter tube 103 is always located in the puncture needle tube 102. After puncture, the sheath seat 301 and the proximal end shell 4 are locked by the sheath seat locking part 302.

[0144] After puncture, the puncture needle tube 102 is withdrawn by the puncture needle tube adjusting mechanism 6. The distal end of the puncture needle tube 102 is withdrawn, leaving the rotary cutter tube 103, 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, the distal end of the puncture needle tube 102 is located in front of the outer sheath tube 101, and is located between the proximal end and the distal end of the distal metal tube 1032 of the rotary cutter tube 103. Please refer to FIG. 16. The rotary cutter tube 103 is driven by the rotary cutter tube transmission assembly 7 to perform rotary cutting sampling on the tissue.

[0145] After sampling is completed, the rotary cutter tube 103 is withdrawn, and the needle of the puncture needle tube 102 is extended from the distal end of the outer sheath tube 101 to ablate the tissue. Please refer to FIG. 17.

[0146] Although the present application has been disclosed with reference to the above examples, it is not intended to limit the present application. Any person skilled in the art, without departing from the spirit and scope of the present application, can make various changes and modifications, and the scope of protection of the present application should be limited by the scope defined in the claims.

Claims

1. A rotational biopsy needle having an ablation function, characterized by, The device comprises a distal pipeline part and a proximal handheld part, the distal pipeline part comprises, from outside to inside, an outer sheath tube, a puncture needle tube and a rotary cutter tube; The proximal handheld part comprises a proximal shell and a puncture depth adjusting mechanism, the puncture depth adjusting mechanism comprises a sheath seat and a sheath seat locking member, the sheath seat is a sleeve structure, the distal end of which is fixedly sleeved on the proximal end of the outer sheath tube, the proximal end of the puncture needle tube passes through the sheath seat into the proximal shell, the proximal shell can be axially moved relative to the sheath seat and is locked with the sheath seat through the sheath seat locking member; The sheath seat is provided with a conductive patch inside, the conductive patch is in direct contact with the puncture needle tube, the sheath seat is provided with a high-frequency connecting port, and the high-frequency connecting port is connected with the conductive patch; during ablation, the distal end of the puncture needle tube extends out of the distal end of the outer sheath tube into the tissue as a transmitting electrode.

2. The rotary cutting biopsy needle of claim 1 wherein, The outer sheath tube is made of high-molecular insulating material.

3. The rotary cutting biopsy needle of claim 1 wherein, The conductive patch is a metal spring sheet, one end of the metal spring sheet is fixed in the sheath seat.

4. The rotary cutting biopsy needle of claim 1 wherein, The proximal handheld part further comprises a puncture needle tube adjusting mechanism and a rotary cutter tube transmission assembly, the puncture needle tube is installed in the proximal shell through the puncture needle tube adjusting mechanism, the puncture needle tube is axially moved by driving the puncture needle tube adjusting mechanism; the rotary cutter tube is installed in the proximal shell through the rotary cutter tube transmission assembly, the rotary cutter tube is circumferentially rotated and axially moved by driving the rotary cutter tube transmission assembly; Before puncture, the distal end of the puncture needle tube is located in the outer sheath tube, and the distal end of the rotary cutter tube is located in the puncture needle tube; during puncture, the sheath seat locking member does not lock the sheath seat and the proximal shell, the proximal shell is pushed to the distal end, so that the proximal shell drives the puncture needle tube and the rotary cutter tube to pass out of the distal end of the outer sheath tube and puncture the tissue, the distal end of the rotary cutter tube is always located in the puncture needle tube during the puncture process; after puncture, the rotary cutter tube extends out of the distal end of the puncture needle tube to rotary cut and sample the tissue; After sampling is completed, the rotary cutter tube is withdrawn, the distal end of the puncture needle tube extends out of the distal end of the outer sheath tube to ablate the tissue.

5. The rotary cutting biopsy needle of claim 4 wherein, The puncture needle tube adjusting mechanism comprises a puncture needle tube sleeve and an elastic clamping structure, the puncture needle tube sleeve is located in the proximal shell and is fixedly sleeved on the puncture needle tube; at least one outer side of the puncture needle tube sleeve is provided with the elastic clamping structure, at least one side of the tube wall of the proximal shell is axially provided with a puncture needle tube adjusting groove, and the elastic clamping structure penetrates through the puncture needle tube adjusting groove; the elastic clamping structure comprises a key and at least one limiting column which are integrally arranged, and a plurality of limiting clamping grooves are arranged on at least one side groove wall of the puncture needle tube adjusting groove; in a natural state, the limiting column is located in the limiting clamping groove, the limiting column is separated from the limiting clamping groove into the proximal shell by pressing the key, and then the puncture needle tube can be axially moved along the puncture needle tube adjusting groove following the key.

6. The rotary cutting biopsy needle of claim 5 wherein, The center of the puncture needle tube sleeve is provided with a mounting hole in the axial direction, the puncture needle tube penetrates through the mounting hole and is fixed with the mounting hole; the proximal end of the tube wall on at least one side of the mounting hole of the puncture needle tube sleeve is provided with a hollow area, the outside of the hollow area is provided with an elastic pressing strip, the elastic pressing strip is arranged in the axial direction of the puncture needle tube sleeve, and the distal end of the elastic pressing strip is fixedly connected with the puncture needle tube sleeve, the elastic clamping structure is fixed at the proximal end of the elastic pressing strip, the key is pressed, the limiting column moves to the hollow area with the proximal end of the elastic pressing strip, so that the limiting column is separated from the limiting clamping groove.

7. The rotary cutting biopsy needle of claim 4 wherein, The rotary cutting knife tube transmission assembly includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism. By driving the circumferential rotation transmission mechanism, the rotary cutting knife tube is driven to rotate, so that the rotary cutting knife tube cuts the tissue. By driving the axial movement transmission mechanism, the rotary cutting knife tube is driven to move axially to adjust the cutting depth of the rotary cutting knife tube.

8. The rotary cutting biopsy needle of claim 7 wherein, The circumferential rotation transmission mechanism includes a mandrel assembly and a rotating shaft in the proximal end shell. The mandrel assembly is fixedly sleeved on the rotary cutting knife tube. The rotating shaft is sleeved on the mandrel assembly and is axially slidably connected with the mandrel assembly and circumferentially fixedly connected with the mandrel assembly. The rotating shaft is coaxially fixedly connected with a rotating gear. The rotating gear is driven by a rotating drive motor, so that the rotating gear drives the rotating shaft to rotate. The axial movement transmission mechanism includes a screw sleeve and a transmission screw. The screw sleeve is rotationally arranged in the proximal end shell and is in threaded engagement with the transmission screw. The screw sleeve is coaxially fixedly connected with a stroke gear. The stroke gear is driven by a stroke drive motor to rotate. The stroke gear drives the screw sleeve to rotate. The rotation of the screw sleeve is converted into the axial movement of the transmission screw. The transmission screw is sleeved on the rotating shaft and is axially fixedly connected with the mandrel assembly and circumferentially rotationally connected with the mandrel assembly.

9. The rotary cutting biopsy needle of claim 8 wherein, The mandrel assembly includes a fixed tube and an inner knife sleeve. The fixed tube is fixedly sleeved on the rotary cutting knife tube. The inner knife sleeve is fixedly sleeved on the fixed tube. The rotating shaft is sleeved on the inner knife sleeve. The rotating shaft and the inner knife sleeve are axially slidably connected by inserting the axial protrusion into the axial guide groove and circumferentially fixedly connected. The inner knife sleeve and the transmission screw are circumferentially rotationally connected by inserting the annular limiting clamping piece into the annular limiting clamping groove and axially fixedly connected.

10. The rotary cutting biopsy needle of claim 8 wherein, The inner wall of the proximal end shell is further provided with a guide rail. The transmission screw is slidably arranged on the guide rail.

11. The rotary cutting biopsy needle of claim 1 wherein, The outer sheath tube is further provided with an endoscope fixing member. The endoscope fixing member includes a lock sleeve and a locking member. The lock sleeve includes an integrated connecting part and a locking part. The connecting part is used for fixedly connecting with the endoscope. The locking part is movably sleeved on the outer sheath tube, and the locking part can be locked on the outer sheath tube by the locking member.

12. The rotary cutting biopsy needle of claim 1 wherein, The proximal end of the proximal end shell is provided with a negative pressure interface for communicating with a negative pressure device, a connecting sleeve is arranged in the proximal end shell, the proximal end of the connecting sleeve is in sealed communication with the negative pressure interface, the proximal end of the rotary cutting knife 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 cutting knife tube through a dynamic sealing element.

13. A rotational biopsy system with ablation functionality, comprising: The system comprises the rotary biopsy needle, the negative pressure electrode and the host machine as claimed in any one of claims 1 to 12, the high-frequency connection port is electrically connected to the host machine through a first connecting line, the negative pressure electrode is electrically connected to the host machine through a second connecting line, the negative pressure electrode is attached to the patient, and the transmitting electrode and the negative pressure electrode form a loop.

14. The rotary cutting biopsy system of claim 13, wherein, A foot switch is further included, and the foot switch is electrically connected to the host machine.

Images