Rotary cutting biopsy needle with ablation function and biopsy system

Abstract

The invention provides a rotary cutting biopsy needle with an ablation function and a biopsy system.The rotary cutting biopsy needle comprises a far-end pipeline part and a near-end handheld part, and the far-end pipeline part comprises an outer sheath tube, a puncture needle tube and a rotary cutting knife tube which are movably arranged in a sleeving mode from outside to inside in sequence; the near-end handheld part comprises a near-end shell and a puncture depth adjusting mechanism, the puncture depth adjusting mechanism comprises a sheath base and a sheath base locking piece, the sheath base is of a sleeve structure, the far end of the sheath base is fixedly arranged at the near end of the outer sheath tube in a sleeving mode, the near end of the puncture needle tube penetrates through the sheath base into the near-end shell, and the near-end shell can axially move relative to the sheath base; the sheath seat and the sheath seat are locked through a sheath seat locking piece; a conductive patch is arranged in the sheath base, the conductive patch is in direct contact with the puncture needle tube, and a high-frequency connecting port is formed in the sheath base and is connected with the conductive patch; during ablation, the far end of the puncture needle tube extends into the tissue from the far end of the outer sheath tube to serve as an emitting electrode.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a rotary biopsy needle and a biopsy system with ablation function. Background Art

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

[0003] Tumor ablation has the advantages of rapid heating, short operation time, and large ablation range, and has been used more and more widely. Its intervention method is usually to enter the lesion through skin puncture or bronchoscopic imaging under the guidance of medical images. The heat generated at the front end of the ablation electrode kills the cancer cells in the lesion, thereby inhibiting the growth of the tumor and shrinking the tumor, thereby preventing the tumor from continuing to grow and prolonging the patient's survival time.

[0004] Before ablation surgery, it is usually necessary to use biopsy to take samples of the lesions. Endoscopic ultrasound-guided transbronchial needle aspiration biopsy is a minimally invasive examination technique that uses ultrasound to guide the puncture biopsy of the lungs, peripulmonary tissues, and lymph nodes. Its advantages are that it can avoid important parts such as large blood vessels and nerves as much as possible under real-time ultrasound monitoring, while reducing the risk of heavy bleeding and improving the accuracy of sampling. It is also less invasive, simple to operate, and relatively safe.

[0005] Existing biopsy needles only have the function of sampling. They cannot stop bleeding tissue during sampling, nor can they ablate diseased tissue after sampling. Therefore, ablation surgery can only be performed through other equipment or devices. Switching equipment back and forth is complicated and costly. Summary of the invention

[0006] In order to solve the above technical problems, an embodiment of the present invention provides a rotary cutting biopsy needle with ablation function, comprising a distal pipeline part and a proximal hand-held part, wherein the distal pipeline part comprises an outer sheath tube, a puncture needle tube and a rotary cutting knife tube which are movably sleeved in sequence from outside to inside;

[0007] The proximal handheld part includes a proximal shell and a puncture depth adjustment mechanism, and the puncture depth adjustment mechanism includes a sheath seat and a sheath seat locking piece. The sheath seat is a sleeve structure, and its distal end 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, and the proximal shell can move axially relative to the sheath seat and is locked with the sheath seat through the sheath seat locking piece.

[0008] A conductive patch is provided in the sheath seat, which is in direct contact with the puncture needle tube. A high-frequency connection port is provided on the sheath seat, 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 to serve as a transmitting electrode.

[0009] Optionally, the outer sheath is made of polymer insulating material.

[0010] Optionally, the conductive patch is a metal spring, and one end of the metal spring is fixed in the sheath seat.

[0011] Optionally, the proximal handheld part further includes a puncture needle tube adjustment mechanism and a rotary cutter tube transmission assembly, the puncture needle tube is installed in the proximal shell through the puncture needle tube adjustment mechanism, and the puncture needle tube is moved axially by driving the puncture needle tube adjustment mechanism; the rotary cutter tube is installed in the proximal shell through the rotary cutter tube transmission assembly, and the rotary cutter tube is driven to perform circumferential rotation and axial movement;

[0012] 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 sheath seat locking piece does not lock the sheath seat and the proximal shell, and by pushing the proximal shell toward the distal end, the proximal shell drives the puncture needle tube and the rotary cutting knife tube to pass through the distal end of the outer sheath tube and puncture the tissue. During the puncture process, the distal end of the rotary cutting knife tube is always located in the puncture needle tube; after the puncture is completed, the rotary cutting knife tube extends from the distal end of the puncture needle tube to perform rotary cutting sampling on the tissue; after sampling is completed, the rotary cutting knife tube is withdrawn, and the distal end of the puncture needle tube is extended from the distal end of the outer sheath tube to ablate the tissue.

[0013] Optionally, 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 slot wall of the puncture needle tube adjustment slot, and 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, so that the puncture needle tube can follow the button to move axially along the puncture needle tube adjustment slot.

[0014] Optionally, a mounting hole is axially provided at the center of the puncture needle tube sleeve, and the puncture needle tube passes through the mounting hole and is fixed to the mounting hole; a hollow area is provided at the proximal end of at least one side tube wall of the puncture needle tube sleeve located at the mounting hole, and an elastic strip is provided on the outer side of the hollow area, the elastic strip is axially arranged along the puncture needle tube sleeve, and the distal end of the elastic strip is fixedly connected to the puncture needle tube sleeve, the elastic locking structure is fixed to the proximal end of the elastic strip, and the button is pressed, and the limit column follows the proximal end of the elastic strip to move toward the hollow area, so that the limit column disengages from the limit slot.

[0015] Optionally, the rotary cutter tube transmission assembly includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism. The circumferential rotation transmission mechanism is driven to drive the rotary cutter tube to rotate so that the rotary cutter tube cuts the tissue; and the axial movement transmission mechanism is driven to drive the rotary cutter tube to move axially to adjust the cutting depth of the rotary cutter tube.

[0016] Optionally, the circumferential rotation transmission mechanism includes a core shaft assembly and a rotating shaft located in the proximal housing, the core shaft assembly is fixedly sleeved on the rotary cutter tube, the rotating shaft 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 shaft, and the rotating gear is driven by a rotating drive motor, so that the rotating gear drives the rotating shaft to rotate;

[0017] The axial movement transmission mechanism includes a screw sleeve and a transmission screw, wherein the screw sleeve is rotatably arranged in the proximal housing and is threadedly meshed with the transmission screw for transmission; the screw sleeve is coaxially fixedly connected with a stroke gear, and the stroke gear is driven by a stroke drive motor to perform rotational motion, and the stroke gear drives the screw sleeve to rotate, and the rotational motion of the screw sleeve is converted into axial movement of the transmission screw;

[0018] The transmission screw is sleeved on the rotating shaft and is relatively fixed to the core shaft assembly in the axial direction and is relatively rotatably connected in the circumferential direction.

[0019] Optionally, the mandrel assembly includes a fixed tube and an inner knife sleeve, the fixed tube fixedly sleeve is on the rotary cutter tube, the inner knife sleeve fixedly sleeve is on the fixed tube, the rotating shaft sleeve is on the inner knife sleeve, and the rotating shaft and the inner knife sleeve are connected by an axial protrusion inserted into an axial guide groove to achieve axial sliding connection and circumferential fixed connection;

[0020] The inner knife sleeve and the transmission screw are connected in a circumferential rotational direction and fixedly connected in an axial direction by inserting an annular limiting clamping piece provided circumferentially into an annular limiting clamping groove.

[0021] Optionally, a guide rail is further provided on the inner wall of the proximal shell, and the transmission screw is slidably arranged on the guide rail.

[0022] Optionally, an endoscope fixing device is also provided on the outer sheath tube, and the endoscope fixing device includes a locking sleeve and a locking member, and the locking sleeve includes an integrally arranged connecting portion and a locking portion, the connecting portion is used to be fixedly connected to the endoscope, the locking portion is movably sleeved on the outer sheath tube, and the locking portion can be locked on the outer sheath tube by the locking member.

[0023] Optionally, a negative pressure interface for connecting to a negative pressure device is opened at the proximal end of the proximal shell, a connecting sleeve is provided in the proximal shell, the proximal end of the connecting sleeve is sealed and connected to the negative pressure interface, the proximal end of the rotary cutter tube is inserted into the connecting sleeve from the distal end of the connecting sleeve, and a dynamic seal is performed between the connecting sleeve and the rotary cutter tube through a dynamic seal.

[0024] Another embodiment of the present invention also provides a rotary biopsy system with ablation function, including the rotary biopsy needle, negative pressure electrode and main unit described in the above embodiment. During ablation, the high-frequency connection port is electrically connected to the main unit through a first connection line, the negative pressure electrode is electrically connected to the main unit through a second connection line, the negative pressure electrode is attached to the patient, and the transmitting electrode and the negative pressure electrode form a loop.

[0025] Optionally, the rotary biopsy system further includes a foot switch, and the foot switch is electrically connected to the host.

[0026] Compared with the prior art, the technical solution of the embodiment of the present invention has the following beneficial effects:

[0027] 1. The rotary biopsy needle and rotary biopsy system provided by the present invention can not only perform rotary sampling, but also perform ablation treatment on the diseased tissue after sampling.

[0028] 2. 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 sealed and connected with a connecting sleeve. The connecting sleeve is arranged in the proximal shell, and the rotary cutting knife tube is inserted into the connecting sleeve and dynamically sealed with the connecting sleeve through a dynamic seal. Therefore, the sealing problem of the rotary cutting knife tube is solved, and the negative pressure suction of the rotary cutting biopsy needle is realized.

[0029] 3. In the present invention, the distal tubing portion includes an outer sheath, a puncture needle tube, and a rotary cutter tube from the outside to the inside. Before puncture, the distal end of the puncture needle tube is located inside the outer sheath, and the distal end of the rotary cutter tube is located inside the puncture needle tube. During puncture, the puncture needle tube and the rotary cutter tube penetrate the tissue from the distal end of the outer sheath together, and during the puncture, the distal end of the rotary cutter tube is always located inside the puncture needle tube. After the puncture is completed, the rotary cutter tube extends from the distal end of the puncture needle tube to sample by rotary cutting the tissue. Since the distal end of the rotary cutter tube is located inside the puncture needle tube during puncture, the rotary cutter tube can penetrate into 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.

[0030] 4. In the present invention, the outer sheath serves as the outermost layer of the distal tubing portion of the biopsy needle, and its inner cavity can completely accommodate the puncture needle tube and the rotary cutting knife tube. Therefore, before puncture, the distal end of the puncture needle tube is placed in the outer sheath, and the distal end of the rotary cutting knife tube is placed in the puncture needle tube. During the process of transporting the outer sheath to the working channel of the endoscope, the puncture needle or the rotary cutting knife is prevented from damaging the endoscope.

[0031] 5. Negative pressure suction can increase the sampling volume of the rotary cutter tube. During sampling, as the tissue in the inner cavity of the rotary cutter tube increases, the friction between the tissue and the rotary cutter tube will continue to increase. The friction resistance will affect the sample tissue from entering the deep cavity of the rotary cutter tube, resulting in the inability to increase the sample tissue obtained. The suction provided by the negative pressure can overcome the friction resistance, suck more sample tissue into the inner cavity of the rotary cutter, and increase the sampling volume.

[0032] 6. Traditional biopsy needles are usually fixed by the proximal housing and the endoscope, and are uniformly operated by the endoscope operator. However, since the rotary biopsy needle is equipped with a motor, the weight of the motor handle and the proximal housing after assembly is relatively large. If the traditional fixing method is adopted, the difficulty of moving the endoscope and the difficulty of operation will be greatly increased after the proximal housing and the endoscope are fixed. The present invention directly fixes the outer sheath tube to the endoscope through the endoscope fixing part on the outer sheath tube, and the proximal housing and the motor handle are held and operated by another special operator. Therefore, the hand-holding and operation of the endoscope are distinguished from the hand-holding and operation of the proximal housing, which reduces the difficulty of operation and increases the adjustment range of the outer sheath tube intervention depth.

[0033] 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

[0034] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0035] Figure 1 A schematic diagram of the structure of a rotary biopsy needle provided in one embodiment of the present invention;

[0036] Figure 2 A schematic diagram of the structure of a distal pipeline portion provided by an embodiment of the present invention;

[0037] Figure 3 A schematic diagram of the structure of a rotary biopsy needle provided in one embodiment of the present invention (without the motor handle installed);

[0038] Figure 4 for Figure 3 A cross-sectional view of

[0039] Figure 5 A schematic diagram of the structure of a rotary biopsy needle before puncture provided by an embodiment of the present invention;

[0040] Figure 6 A schematic diagram of the structure of the rotary biopsy needle after puncture is completed provided by an embodiment of the present invention;

[0041] Figure 7 A schematic diagram of the structure of an endoscope fixing member provided by an embodiment of the present invention;

[0042] Figure 8 An axial diagram of a puncture needle tube adjustment mechanism provided in one embodiment of the present invention;

[0043] Fig. 9 An end view of a puncture needle tube adjustment mechanism provided in one embodiment of the present invention;

[0044] Fig.10 A schematic structural diagram of a rotary cutting blade tube with an outer blade edge provided in one embodiment of the present invention;

[0045] Fig.11 A schematic structural diagram of a rotary cutting blade tube with an inner cutting edge provided in one embodiment of the present invention;

[0046] Fig.12 A schematic diagram of the structure of a rotary cutting blade tube provided in one embodiment of the present invention;

[0047] Fig.13 A schematic diagram of the structure of a rotary cutting blade tube transmission assembly provided in one embodiment of the present invention;

[0048] Fig.14 A schematic diagram of the positions of the outer sheath tube, the puncture needle tube and the rotary cutting knife tube before puncture provided in one embodiment of the present invention;

[0049] Fig.15 A schematic diagram of the positions of the outer sheath tube, the puncture needle tube and the rotary cutting knife tube during puncture provided by an embodiment of the present invention;

[0050] Fig.16 A schematic diagram of the positions of an outer sheath tube, a puncture needle tube and a rotary cutting knife tube during sampling provided by an embodiment of the present invention;

[0051] Fig.17 This is a schematic diagram of the positions of the outer sheath tube, the puncture needle tube and the rotary cutting knife tube during ablation provided by one embodiment of the present invention. DETAILED DESCRIPTION

[0052] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0053] The terms "first", "second", "third", "fourth", etc. (if any) in the specification and claims of the present invention and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the data used in this way can be interchanged where appropriate, so that the embodiments of the present invention described herein can be implemented in an order other than those illustrated or described herein. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions, for example, a process, method, system, product or device that includes a series of steps or units is not necessarily limited to those steps or units clearly listed, but may include other steps or units that are not clearly listed or inherent to these processes, methods, products or devices. The terms "on" and "above" and any variations thereof are intended to describe positional relationships and do not represent a relationship of direct contact between the described objects.

[0054] The existing biopsy needle only has the function of sampling. It cannot stop bleeding tissue during sampling, and it cannot ablate diseased tissue after sampling.

[0055] In order to solve the above technical problems, the present invention provides a rotary cutting biopsy needle with ablation function, comprising a distal pipeline part and a proximal hand-held part, wherein the distal pipeline part includes an outer sheath tube, a puncture needle tube and a rotary cutting knife tube which are movably sleeved in sequence from outside to inside;

[0056] The proximal handheld part includes a proximal shell and a puncture depth adjustment mechanism, and the puncture depth adjustment mechanism includes a sheath seat and a sheath seat locking piece. The sheath seat is a sleeve structure, and its distal end 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, and the proximal shell can move axially relative to the sheath seat and is locked with the sheath seat through the sheath seat locking piece.

[0057] A conductive patch is provided in the sheath seat, which is in direct contact with the puncture needle tube. A high-frequency connection port is provided on the sheath seat, 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 to serve as a transmitting electrode.

[0058] Furthermore, the present invention also provides a rotary biopsy system with ablation function, including the above-mentioned rotary biopsy needle, negative pressure electrode and host. During ablation, the distal end of the puncture needle tube extends from the distal end of the outer sheath tube into the tissue to serve as a transmitting electrode. The high-frequency connection port is electrically connected to the host through a first connecting line, and the negative pressure electrode is electrically connected to the host 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.

[0059] The present invention does not limit the applicable part of the rotary biopsy needle, and therefore, the present invention does not limit the specific part of the patient where the negative pressure electrode is attached, and can be set according to specific usage requirements. For example, the rotary biopsy needle is used for transbronchial needle aspiration biopsy under the guidance of an ultrasonic endoscope, and the negative pressure electrode is attached to the patient's buttocks.

[0060] In order to facilitate the operator's operation, the rotary biopsy system is characterized by further comprising a foot switch, which is electrically connected to the host and is used to control the ablation switch.

[0061] The rotary biopsy needle and rotary biopsy system provided by the present invention can not only perform rotary sampling, but also perform ablation treatment on the diseased tissue after sampling.

[0062] In order to make the above-mentioned purposes, features and beneficial effects of the present invention more obvious and understandable, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0063] Please refer to Figures 1 to 4The present invention provides a rotary cutting biopsy needle, comprising a distal pipeline part 1 and a proximal hand-held part, wherein the distal pipeline part 1 comprises an outer sheath tube 101, a puncture needle tube 102 and a rotary cutting knife tube 103 which are movably sleeved in sequence from outside to inside.

[0064] The proximal handheld part includes a proximal housing 4, a puncture depth adjustment mechanism 3, a puncture needle tube adjustment mechanism 6 and a rotary cutter tube transmission assembly 7, please refer to Figure 3 The puncture depth adjustment mechanism 3 includes a sheath seat 301 and a sheath seat locking piece 302. The sheath seat 301 is a sleeve structure, and its distal end is fixedly sleeved on the proximal end of the outer sheath tube 101. The proximal ends of the puncture needle tube 102 and the rotary cutter tube 103 both pass through the sheath seat 301 to the proximal shell 4. The puncture needle tube 102 is installed in the proximal shell 4 through the puncture needle tube adjustment mechanism 6, and the puncture needle tube adjustment mechanism 6 is driven to make the puncture needle tube move axially; the rotary cutter tube 103 is installed in the proximal shell 4 through the rotary cutter tube transmission assembly 7, and the rotary cutter tube 103 is driven to make circumferential rotation and axial movement. The proximal shell 4 can move axially relative to the sheath seat 301, and the sheath seat 301 can be locked with the proximal shell 4 through the sheath seat locking piece 302.

[0065] A conductive patch 304 is disposed in the sheath seat 301 , and the conductive patch 304 is in direct contact with the puncture needle tube 102 . A high-frequency connection port 303 is disposed on the sheath seat 301 , and the high-frequency connection port 303 is connected to the conductive patch 304 .

[0066] The present invention does not impose any specific restrictions on the shape and specific structure of the conductive patch 304 , as long as it can always be in direct contact with the puncture needle tube 102 , the purpose of which is to electrically connect the puncture needle tube 102 to the host through the high-frequency connection port 303 .

[0067] As an embodiment, the conductive patch 304 is a metal shrapnel, one end of which is fixed in the sheath seat 301, and through the elastic force of the metal shrapnel, it is always in direct contact with the puncture needle tube 102. The outer sheath tube 101 is made of a polymer 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) extending from the distal end of the outer sheath tube 101 and inserted into the target tissue as an emitting electrode during ablation to ablate the tissue, and also has a hemostatic effect during ablation.

[0068] Before puncture, the distal end of the puncture needle tube 102 is located in the outer sheath tube 101, and the distal end of the rotary cutting knife tube 103 is located in the puncture needle tube 102; during puncture, the sheath seat locking piece 302 does not lock the sheath seat 301 and the proximal shell 4, and by pushing the proximal shell 4 toward the distal end, the puncture needle tube 102 and the rotary cutting knife tube 103 are pushed out from the distal end of the outer sheath tube 101 to puncture the tissue, and during the puncture, the distal end of the rotary cutting knife tube 103 is always located in the puncture needle tube 102; after the puncture is completed, the rotary cutting knife tube 103 extends from the distal end of the puncture needle tube 102 to sample by rotary cutting the tissue; after sampling is completed, the rotary cutting knife 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.

[0069] Since the distal end of the rotary cutter tube 103 is located inside the puncture needle tube 102 during puncture, the rotary cutter tube 103 can penetrate into the human tissue together with the puncture needle tube 102, thereby ensuring the smoothness of the outer surface of the puncture needle tube 102 and making puncture easier.

[0070] 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.

[0071] The present invention does not limit the material of the outer sheath 101, and preferably uses a smooth polymer insulating material such as PTFE and PEEK to prevent damage to the endoscope during the process of passing through the working channel of the endoscope and ensure its delivery performance. In addition, during ablation, the part of the puncture needle tube 102 except the needle part is insulated to prevent it from damaging the endoscope and other human tissues.

[0072] Traditional biopsy needles are usually fixed by the proximal shell and the endoscope, and are operated uniformly by the endoscope operator. However, since the rotary biopsy needle has a motor, the motor handle and the proximal shell are heavy after assembly. If the traditional fixing method is used, the proximal shell and the endoscope will be fixed, which will greatly increase the difficulty of the endoscope operator to move the endoscope and operate.

[0073] In order to solve the above technical problems, the present invention directly fixes the outer sheath tube 101 to the endoscope through the endoscope fixing member 2 on the outer sheath tube 101, and the proximal housing and the motor handle are held and operated by another special operator. Therefore, the holding and operation of the endoscope are distinguished from the holding and operation of the proximal housing, which reduces the difficulty of operation and increases the adjustment range of the intervention depth of the outer sheath tube 101.

[0074] As an example, please refer to Figure 7 The endoscope fixing member 2 includes a locking member 202 and a locking sleeve 201. The locking sleeve 201 is provided with a connecting portion 2011 fixedly connected to the endoscope and a locking portion 2013 movably sleeved on the outer sheath tube 101. The locking portion 2013 can move axially relative to the outer sheath tube 101, and the locking portion 2013 is locked on the outer sheath tube 101 through the locking member 202.

[0075] This embodiment does not impose any specific restrictions on the fixed connection method between the connecting portion 2011 and the endoscope, such as threaded connection, clamping or other detachable fixed connection methods. At the same time, this embodiment does not impose any specific restrictions on the method in which the locking member 202 locks the locking portion 2013 on the outer sheath 101, such as nut locking, locking screw locking, etc.

[0076] As an embodiment, the connecting portion 2011 is a first Luer connector, and the proximal end of the working channel of the endoscope is provided with a second Luer connector adapted to the first Luer connector, and the first Luer connector is cooperatively connected with the second Luer connector.

[0077] In a specific embodiment, the connecting portion 2011 and the locking portion 2013 are coaxially fixedly connected via an intermediate connecting sleeve 2012, and both the connecting portion 2011 and the intermediate connecting sleeve 2012 are movably sleeved on the outer sheath 101, the connecting portion 2011 is located at the distal end of the intermediate connecting sleeve 2012, an internal threaded joint is provided on the connecting portion 2011, and an external threaded joint matching the internal threaded joint is provided at the proximal end of the working channel of the endoscope, and the internal threaded joint and the external threaded joint are fastened and connected via threads; the locking portion 2013 is located at the proximal end of the intermediate connecting sleeve 2012, an external thread is provided on the locking portion 2013, and the locking piece 202 is a first locking cap, a threaded hole matching the external thread of the locking portion 2013 is provided in the first locking cap, and the first locking cap is tightened on the locking portion 2013, so that the locking portion 2013 clamps the outer sheath 101.

[0078] The locking part 2013 can be an elastic member such as a silicone structure, and the first locking cap can improve the fixing effect by squeezing the elastic member. The proximal end of the locking part 2013 can also be provided with a plurality of pressure strips at intervals, and the plurality of pressure strips are movably covered on the outer sheath tube 101, and the first locking cap is designed to be a tapered structure that gradually shrinks from the distal end to the proximal end. The first locking cap is tightened with the locking part 2013, so that the plurality of pressure strips are gathered and clamped on the outer sheath tube 101, thereby realizing the fixed connection between the outer sheath tube 101 and the endoscope.

[0079] During transportation, the endoscope is fixedly connected to the connecting portion 2011, and the first locking cap is in a loosened state. At this time, the endoscope can be moved arbitrarily to adjust the relative position of the outer sheath tube 101 and the endoscope. When the endoscope reaches the specified position, the adjustment is completed, and the first locking cap is locked. At this time, the locking portion 2013 will clamp the outer sheath tube 101 as the first locking cap is locked and contracted, thereby fixing the outer sheath tube 101 and the endoscope.

[0080] Since the locking portion 2013 can move axially relative to the outer sheath tube 101 , the endoscope fixture 2 can be locked at any position of the outer sheath tube 101 , thereby expanding the intervention length adjustment range of the outer sheath tube 101 .

[0081] Since the technical solution of adjusting and locking the two components by cooperating with the locking piece 202 and the locking sleeve 201 is a relatively mature technology in the mechanical field, all technical solutions of adjusting and locking the outer sheath 101 and the endoscope by cooperating with the locking piece 202 and the locking sleeve 201 are within the protection scope of the present invention.

[0082] Similarly, since the sheath seat 301 and the sheath seat locking piece 302 of the puncture depth adjustment mechanism 3 also cooperate to achieve a technical solution for adjusting and locking the two components, this technical solution belongs to a relatively mature technology in the mechanical field. Therefore, the present invention does not limit the specific structure of the sheath seat 301 and the sheath seat locking piece 302. Any technical solution that adjusts and locks the outer sheath tube 101 and the proximal shell 4 by cooperating with the sheath seat 301 and the sheath seat locking piece 302 is within the protection scope of the present invention.

[0083] As an embodiment, the sheath seat 301 is a sleeve structure, the distal end of the sheath seat 301 is coaxially fixedly connected with the proximal end of the outer sheath tube 101, and the proximal movable outer sleeve of the sheath seat 301 is on the proximal outer shell 4; the proximal outer wall of the sheath seat 301 is provided with an external thread, and the sheath seat locking piece 302 is a second locking cap, and the second locking cap is provided with a threaded hole adapted to the external thread of the sheath seat 301, and the sheath seat 301 is clamped to the proximal outer shell 4 by tightening the second locking cap on the sheath seat 301.

[0084] The proximal end of the sheath seat 301 can be an elastic member such as a silicone structure, and the second locking cap improves the fixing effect by squeezing the elastic member. The proximal end of the sheath seat 301 is not limited to the elastic member, and a plurality of beadings can be arranged at intervals, and the plurality of beadings are movably covered on the proximal shell 4. The second locking cap is designed to be a tapered structure that gradually shrinks from the distal end to the proximal end. The second locking cap is tightened with the sheath seat 301, so that the plurality of beadings are gathered and clamped on the proximal shell 4, thereby realizing the locking connection between the sheath seat 301 and the proximal shell 4.

[0085] In the initial state before puncture, the distal end of the puncture needle tube 102 is located in the outer sheath tube 101, and the distal end of the rotary cutting knife tube 103 is located in the puncture needle tube 102, and the outer sheath tube 101 is transported to the working channel of the endoscope. When the outer sheath tube 101 reaches the specified position and is fixed, puncture breakthrough can be performed. At this time, the puncture depth adjustment mechanism 3 is adjusted according to the puncture depth requirement. Specifically, the second locking cap is loosened, the sheath seat 301 is held, and the proximal shell 4 is quickly pushed to the distal end. The proximal shell 4 will drive the distal ends of the puncture needle tube 102 and the rotary cutting knife tube 103 to pass out of the outer sheath tube 101 and puncture the obstacle tissue such as the bronchial wall. After the puncture is completed, the second locking cap is locked.

[0086] When the proximal shell 4 is pushed quickly toward the distal end, in order to facilitate manual operation of the proximal shell 4, an annular protrusion 401 is provided on the outer side of the proximal shell 4. By pushing the annular protrusion 401, the purpose of pushing the proximal shell 4 quickly toward the distal end is achieved.

[0087] In order to identify the puncture depth, a puncture depth scale is provided on the proximal housing 4 .

[0088] Of course, the sheath seat locking member 302 of the present invention is not limited to the lock cap structure, and can also be a threaded fastener. Specifically, a threaded hole is provided on one side wall of the sheath seat 301, and the sheath seat locking member 302 is a threaded fastener adapted to the threaded hole. The first end of the threaded fastener passes through the threaded hole into the sheath seat, and the second end is located outside the sheath seat 301. The threaded fastener is tightened by manually tightening the second end of the threaded fastener, so that the first end of the threaded fastener abuts against the proximal housing 4, thereby fixing the proximal housing 4 to the sheath seat 301. The threaded fastener is a locking screw or other structure.

[0089] 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. The puncture needle tube 102 has a needle tip, through which puncture breakthrough can be achieved.

[0090] In order to improve the effect of ultrasonic imaging and facilitate observation of the position of the puncture needle tube 102, the puncture needle tube 102 is provided with a first ultrasonic reflection area on the outer surface near the needle tip 1021. The first ultrasonic reflection area is required to be an uneven texture. As for the texture shape of the first ultrasonic reflection area, the present invention does not make any specific restrictions. For example, the roughness of the outer surface of the puncture needle tube 102 is increased by processes such as threading and dotting to improve the imaging effect of the puncture needle tube 102 under ultrasound.

[0091] In the present invention, the puncture needle tube 102 is installed in the proximal shell 4 through the puncture needle tube adjustment mechanism 6, and 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.

[0092] As an example, please refer to Figure 8 and Fig. 9 The puncture needle tube adjustment mechanism 6 includes a puncture needle tube sleeve 602 and an elastic locking structure 601. The puncture needle tube sleeve 602 is located in the proximal shell 4 and is fixedly mounted on the proximal end of the puncture needle tube 102; at least one outer side of the puncture needle tube sleeve 602 is provided with the elastic locking structure 601, and at least one side of the tube wall of the proximal shell 4 is axially provided with a puncture needle tube adjustment groove, and the elastic locking structure 601 passes through the puncture needle tube adjustment groove; the elastic locking structure The structure 601 includes an integrally arranged button 6011 and at least one limiting column 6012. A plurality of limiting slots are arranged on at least one side wall of the puncture needle tube adjustment slot. In a natural state, the limiting column 6012 is located in the limiting slot. By pressing the button 6011, the limiting column 6012 is separated from the limiting slot to the proximal shell 4, thereby enabling the puncture needle tube 102 to follow the button 6011 and move axially along the puncture needle tube adjustment slot.

[0093] In this embodiment, when the button 6011 is pressed, the limiting column 6012 is disengaged from the limiting slot, and the puncture needle tube 102 can follow the button 6011 and move arbitrarily along the puncture needle tube adjustment slot in its axial direction, thereby realizing the axial position adjustment of the puncture needle tube 102. After releasing the button, the button is reset under the action of elasticity, and the limiting column 6012 is inserted into the limiting slot of the puncture needle tube adjustment slot, thereby realizing the fixation of the puncture needle tube 102.

[0094] In the present invention, after the puncture is completed, the puncture needle tube 102 is withdrawn through the puncture needle tube adjustment mechanism 6, so that the distal end of the rotary cutter tube 103 extends from the distal end of the puncture needle, and the rotary cutter tube 103 starts to perform rotary cutting. Of course, the method of making the distal end of the rotary cutter tube 103 extend from the distal end of the puncture needle is not limited to withdrawing the puncture needle tube 102, and the distal end of the rotary cutter tube 103 can also be directly extended from the distal end of the puncture needle tube 102. As an embodiment, the distal end of the rotary cutter tube 103 is extended from the distal end of the puncture needle tube 102 by driving the rotary cutter tube transmission component 7.

[0095] 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.

[0096] In order to facilitate manual operation, it is preferred to respectively set an elastic retaining structure 601 on the two corresponding outer sides of the puncture needle tube sleeve 602, and the elastic retaining structure 601 is arranged along the radial direction of the puncture needle tube sleeve 602. A puncture needle tube adjustment groove is respectively provided along the axial direction on the two corresponding sides of the tube wall of the proximal shell 4, and the two elastic retaining structures 601 respectively penetrate a puncture needle tube adjustment groove. A plurality of limit slots are arranged at intervals on the groove walls on both sides of the puncture needle tube adjustment groove, and correspondingly, a limit column 6012 is respectively arranged on both sides of the button 6011, and the button 6011 and the limit columns 6012 on both sides thereof are arranged along the circumference of the puncture needle tube sleeve 602. In the natural state, the limit columns 6012 on both sides of the button 6011 are respectively located in a limit slot on the groove walls on both sides of the puncture needle tube adjustment groove. When it is necessary to press the button 6011, the operator presses the two buttons 6011 with two fingers at the same time to disengage the limit column 6012 from the limit slot, and then pushes the button 6011 to adjust the position of the puncture needle tube 102.

[0097] In one embodiment, a mounting hole 6021 is axially provided at the center of the puncture needle tube sleeve 602, and the puncture needle tube 102 passes through the mounting hole 6021 and is fixed to the mounting hole 6021; a hollow area 6022 is provided at the proximal end of at least one side tube wall of the puncture needle tube sleeve 602 located at the mounting hole 6021, and an elastic strip 6013 is provided on the outer side of the hollow area 6022, and the elastic strip 6013 is arranged along the axial direction of the puncture needle tube sleeve 602, and the distal end of the elastic strip 6013 is fixedly connected to the puncture needle tube sleeve 602, and the elastic locking structure 601 is fixed to the proximal end of the elastic strip 6013, and the button 6011 is pressed, and the limiting column 6012 follows the proximal end of the elastic strip 6013 to move toward the hollow area 6022, so that the limiting column 6012 disengages from the limiting slot.

[0098] The rotary cutter tube 103 is a tubular structure, which is the innermost layer of the distal pipeline part of the biopsy needle. The distal end of the rotary cutter tube 103 is provided with an annular blade to ensure that the rotary cutter tube 103 can smoothly cut the tissue. The annular blade preferably adopts a flat structure to ensure the integrity of the tissue after rotary cutting, so as not to be crushed and affect the pathological analysis.

[0099] As an example, please refer to Fig.10 The annular blade at the distal end of the rotary cutter tube 103 is an outer blade edge 1031 formed by removing the inner edges and corners of the distal end surface of the rotary cutter tube 103, and the outer blade edge 1031 is used for cutting low-density tissue.

[0100] As another example, please refer to Fig.11The annular blade at the distal end of the rotary cutter tube 103 is an inner blade edge 1031 ′ formed by removing the outer edges and corners from the distal end surface of the rotary cutter tube 103 . The inner blade edge 1031 ′ is used for cutting high-density tissues.

[0101] In a specific implementation, please refer to Fig.12 The rotary cutter tube 103 includes a distal metal tube 1032, a wire spring tube 1033, a proximal metal tube 1035 and a polymer sealing tube 1034. The distal metal tube 1032 and the proximal metal tube 1035 are both metal tubes, such as stainless steel tubes. The distal end of the distal metal tube 1032 is an annular blade. The distal metal tube 1032 is made of metal to ensure that the rotary cutter tube 103 can smoothly cut the tissue. The proximal metal tube 1035 is made of metal to facilitate its assembly and fixation. The wire spring tube 1033 is a hollow tube woven from metal wires. The metal wires are made of stainless steel or nickel-titanium structure. The wire spring tube 1033 can flexibly transmit the rotation speed and torque in a bent state and effectively reduce vibration. The proximal end of the distal metal tube 1032 and the distal end of the metal wire spring tube 1033 are connected by end face welding to ensure that the outer diameter and inner diameter of the distal metal tube 1032 and the metal wire spring tube 1033 are substantially consistent.

[0102] On the outside of the rotary cutter tube 103, a thin-walled polymer sealing tube 1034 is provided, such as a thin-walled heat shrink tube, which is fixed to the outside of the rotary cutter tube 103 through a heat shrink process to achieve sealing of the rotary cutter tube 103, so that the internal cavity can transmit negative pressure or positive pressure to avoid leakage at the welding position, the gap between the braided tubes, etc. At the same time, the thin-walled heat shrink tube can reduce the friction between the rotary cutter tube and the puncture needle tube during rotation, and avoid wear of the braided metal wire of the rotary cutter tube.

[0103] The proximal metal tube 1035 is wrapped around the proximal outer side of the polymer sealing tube 1034, and the proximal metal tube 1035 and the polymer sealing tube 1034 can be fixed by bonding or other methods. In this way, a sealed tube cavity with only two outlets can be formed inside the rotary cutter tube.

[0104] 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.

[0105] In the art, in order to realize the flexible rotation of the rotary cutter tube 103, the rotary cutter tube 103 realizes the flexible transmission of torque and speed through the rotary cutter soft shaft of the wire spring tube 1033. However, in the state without rigid support, the wire spring tube 1033 is very easy to shake, which affects the sampling effect. In the present invention, the puncture needle tube 102 is sleeved on the outside of the rotary cutter tube 103, and the inner diameter of the puncture needle tube 102 is slightly larger than the outer diameter of the rotary cutter tube 103. Therefore, the puncture needle tube 102 can play a role similar to a sliding bearing. When the rotary cutter tube 103 rotates, the rotary cutter tube 103 rotates in the inner cavity of the puncture needle tube 102 to prevent the rotary cutter tube 103 from shaking, thereby providing rigid support for the rotary cutter tube 103 and improving the stability of the rotary cutter tube 103 when rotating.

[0106] The outer surface of the rotary cutter tube 103 is covered with a polymer sealing tube 1034 , and the polymer sealing tube 1034 is at least sealed on the metal wire spring tube 1033 and at the connection between the metal wire spring tube 1033 and the distal metal tube 1032 .

[0107] In order to reduce the friction between the rotary cutting blade tube 103 and the puncture needle tube 102 during rotation and avoid wear of the braided metal wire of the rotary cutting blade tube 103, the polymer sealing tube 1034 is a heat shrink tube formed by fixing the polymer tube on the outer surface of the rotary cutting blade tube 103 through a heat shrink process. The heat shrink tube can also improve the torsional performance and sealing performance of the metal wire spring tube 103 without losing the bending performance.

[0108] In order to increase the adhesion strength of tissue after cutting and avoid the tissue from falling off after cutting and sampling, the inner wall surface of the rotary cutting blade tube 103 is provided with a rough surface that increases the friction coefficient, such as a threaded surface.

[0109] In order to improve the effect of ultrasonic development, a second ultrasonic reflection area is provided on the outer surface of the distal metal tube 1032. The second ultrasonic reflection area is required to be an uneven texture. As for the texture shape of the second ultrasonic reflection area, the present invention does not make any specific restrictions. For example, the roughness of the outer surface of the distal metal tube 1032 can be increased by processes such as threading and dotting to improve the development effect of the rotary cutting tube 103 under ultrasound.

[0110] In the present invention, the rotary cutter tube transmission assembly 7 is installed in the proximal housing 4 , and 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 tissue.

[0111] By driving the rotary cutting blade tube transmission component 7, the rotary cutting blade tube transmission component 7 drives the rotary cutting blade tube 103 to perform rotary cutting, which is a mature technology in the field. Therefore, the present invention does not limit the specific structure of the rotary cutting blade tube transmission component 7. Any technical solution that can drive the rotary cutting blade tube transmission component 7 so that the rotary cutting blade tube transmission component 7 drives the rotary cutting blade tube 103 to perform rotary cutting is applicable to the present invention.

[0112] Since the rotary cutter tube transmission assembly 7 can not only drive the rotary cutter tube 103 to rotate and cut the tissue, but also adjust the axial stroke of the rotary cutter tube 103 to adjust the cutting depth of the rotary cutter tube 103. As an embodiment, the rotary cutter tube transmission assembly 7 includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism, both of which are connected to the rotary cutter tube 103. The circumferential rotation transmission mechanism drives the rotary cutter tube 103 to rotate so that the rotary cutter tube 103 cuts the tissue; the axial movement transmission mechanism drives the rotary cutter tube 103 to move axially to adjust the axial stroke of the rotary cutter tube 103, thereby adjusting the cutting depth of the rotary cutter tube 103.

[0113] As an example, please refer to Fig.13 The circumferential rotation transmission mechanism includes a core shaft assembly and a rotating shaft 702 located in the proximal shell 4. The core shaft assembly is fixedly sleeved on the rotary cutter tube 103. The rotating shaft 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 shaft 702. The rotating gear 701 is driven by a rotating drive motor, so that the rotating gear 701 drives the rotating shaft 702 to rotate.

[0114] Since the mutually sleeved rotating shaft 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 shaft 702 and the core shaft assembly.

[0115] As an embodiment, the core shaft assembly includes a fixed tube 708 and an inner knife sleeve 706, the fixed tube 708 is fixedly sleeved on the rotary cutting knife tube 103, the inner knife sleeve 706 is fixedly sleeved on the fixed tube 708, the rotating shaft 702 is sleeved on the inner knife sleeve 706, and the rotating shaft 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.

[0116] In a specific implementation, the inner wall of the rotating shaft 702 is provided with a plurality of protrusions at intervals along the circumferential direction, and these protrusions are all provided along the axial direction of the rotating shaft 702; the outer wall of the inner knife sleeve 706 is provided with a plurality of guide grooves adapted to the plurality of protrusions at intervals along the circumferential direction, and these guide grooves are all provided along the axial direction of the inner knife sleeve 706. By inserting a plurality of protrusions into a plurality of guide grooves, the rotating shaft 702 and the inner knife sleeve 706 are axially slidably connected and circumferentially fixedly connected, that is, the rotating shaft 702 and the inner knife sleeve 706 can not only slide relative to each other in the axial direction, but also rotate synchronously in the circumferential direction. Of course, the protrusions can also be provided on the outer wall of the inner knife sleeve 706, and the guide grooves can be provided on the inner wall of the rotating shaft 702. This embodiment does not impose specific restrictions on this.

[0117] The axial movement transmission mechanism includes a screw sleeve 703 and a transmission screw 704. The screw sleeve 703 is sleeved on the transmission screw 704 and is threadedly meshed with the transmission screw 704 for transmission. The screw sleeve 703 is coaxially fixedly connected with a stroke gear 709. The stroke gear 709 is driven by a stroke drive motor to rotate. The stroke gear 709 drives the screw sleeve 703 to rotate, and the rotational movement of the screw sleeve 703 is converted into axial movement of the transmission screw 704. The transmission screw 704 is sleeved on the rotating shaft 702, and is relatively fixed to the core shaft assembly in the axial direction and relatively rotationally connected in the circumferential direction.

[0118] As an embodiment, the proximal handheld portion further includes a motor handle 5, the rotation drive motor and the stroke drive motor are both installed in the motor handle 5, and the motor handle 5 is fixedly connected to the proximal housing 4. The rotation drive motor and the stroke drive motor respectively directly control or control the rotation gear 701 and the stroke gear 709 through gear transmission to realize the rotation and forward and backward movement of the rotary cutting blade tube 103.

[0119] The screw sleeve 703 only performs rotational motion in the proximal housing 4, and does not perform axial movement. In order to limit the axial movement of the screw sleeve 703 in the proximal housing 4, positioning baffles are provided on the proximal housing 4 at the proximal and distal ends of the screw sleeve 703, with the purpose of limiting the screw sleeve 703 between the two positioning baffles to prevent it from performing axial movement.

[0120] In this embodiment, the transmission screw 704 is sleeved on the rotating shaft 702 and is relatively fixedly connected to the core shaft assembly in the axial direction and relatively rotatably connected in the circumferential direction.

[0121] As an embodiment, the inner tool sleeve 706 and the transmission screw 704 are connected in a circumferential rotational direction and fixedly connected in an axial direction by inserting a circumferentially arranged annular limiting clamp into an annular limiting clamping groove.

[0122] In a specific implementation, an annular limiting groove 7061 is provided on the outer circumference of the inner knife sleeve 706, and an annular limiting fixture 705 adapted to the annular limiting groove 7061 is provided on the inner circumference of the transmission screw 704. The annular limiting fixture 705 is inserted into the annular limiting groove 7061 to realize the circumferential rotation connection between the transmission screw 704 and the inner knife sleeve 706, and the axial fixed connection, that is, the inner knife sleeve 706 and the transmission screw 704 can rotate relative to each other, but cannot produce relative displacement in the axial direction. Of course, the inner circumference of the transmission screw 704 can also be provided with an annular limiting groove, and the outer circumference of the inner knife sleeve 706 can be provided with an annular limiting fixture adapted to the annular limiting groove. This embodiment does not impose specific restrictions on this.

[0123] 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 .

[0124] Please refer to Fig.13 The proximal surface of the proximal housing 4 is provided with a negative pressure interface 401 for communicating with the negative pressure device. A connecting sleeve 9 is provided inside the proximal housing 4. The proximal end of the connecting sleeve 9 is sealed and communicated with the negative pressure interface 401. The proximal end of the rotary cutter tube 103 is inserted into the connecting sleeve 9 from the distal end of the connecting sleeve 9. Moreover, the connecting sleeve 9 and the rotary cutter tube 103 are dynamically sealed by a dynamic seal 10. When the rotary cutter tube 103 is rotary cut forward, the rotary cutter tube 103 moves from the proximal end to the distal end. A portion of the rotary cutter tube 103 is always located in the connecting sleeve 9 of the rotary cutter tube 103 and contacts the dynamic seal 10 to form a dynamic seal.

[0125] In the initial position, the present invention does not limit the length of the rotary cutter tube 103 in the connecting sleeve 9. At the same time, when the rotary cutter tube 103 moves from the proximal end to the distal end to the maximum cutting depth, the length of the rotary cutter tube 103 in the connecting sleeve 9 is also not limited and can be set according to actual use requirements. In order to prevent the rotary cutter tube 103 from detaching from the connecting sleeve 9, as an embodiment, in the initial position, the size of the rotary cutter tube 103 in the connecting sleeve 9 is greater than 2 cm.

[0126] 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 .

[0127] As an embodiment, the dynamic seal 10 is a sealing ring, such as a Varisal seal or a silicone seal.

[0128] In a specific embodiment, the outer periphery of the sealing ring is sealedly connected to the inner periphery of the connecting sleeve 9, and the proximal end of the rotary cutter tube 103 is inserted into the sealing ring and dynamically sealed with the sealing ring.

[0129] In another specific embodiment, the sealing ring is fixed on the distal end surface of the connecting sleeve 9, and the proximal end of the rotary cutter tube 103 is inserted into the sealing ring and dynamically sealed with the sealing ring. Please refer to Fig.13 .

[0130] 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.

[0131] In order to facilitate assembly and fixing, the connecting sleeve 9 is made of a metal pipe, such as a steel pipe.

[0132] As an embodiment, the negative pressure interface 401 is connected to one end of the negative pressure pipeline through a Luer connector, and the other end of the negative pressure pipeline is connected to the negative pressure device. After the Luer connector is tightened, the negative pressure can be transmitted from the negative pressure device to the distal end of the rotary cutting blade tube 103.

[0133] Since the rotary cutter tube 103 is a tubular structure with a circular blade at its distal end, after sampling, the tissue at the blade edge needs to be pulled apart to complete the sampling. Therefore, during sampling, the negative pressure device performs negative pressure suction on the rotary cutter tube 103 through the negative pressure interface 401, and the negative pressure suction can increase the pulling force of the rotary cutter tube 103 when retreating, ensuring that the tissue can be successfully pulled apart.

[0134] After the sampling is completed, the syringe injects physiological saline into the rotary cutter tube 103 through the negative pressure interface 401 , and the injected physiological saline provides positive pressure to flush the tissue sample out of the rotary cutter tube 103 .

[0135] The negative pressure device and the syringe may share a common interface, or may use separate interfaces to be connected to the negative pressure interface 401 .

[0136] As an embodiment, the negative pressure interface 401 is also connected to a three-way connector, which includes a first interface, a second interface and a third interface, wherein the first interface is used to communicate with the negative pressure interface 401, the second interface is used to connect the negative pressure device, and the third interface is used to connect the syringe. The three-way connector is provided with an adjustment switch, and the first interface switches the passage with the second interface and the third interface through the adjustment switch. For example, when the adjustment switch is in gear I, the negative pressure suction of the negative pressure device can be transmitted to the distal end of the rotary cutter tube 103 to achieve adsorption of the tissue; when the adjustment switch is in gear II, the syringe can flush out the tissue in the rotary cutter tube 103 for sampling to ensure the integrity of the tissue.

[0137] This embodiment does not limit the specific type of the negative pressure device, such as a negative pressure suction syringe or a negative pressure pump. The following takes the negative pressure device as an example of a negative pressure pump to explain the method for adjusting the negative pressure.

[0138] In order to adjust the negative pressure, the host also includes a main control module, which 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.

[0139] The host also has a negative pressure sensor to monitor the real-time negative pressure of the negative pressure pump and feed back the precise negative pressure value to the main control module. The main control module adjusts the negative pressure value by adjusting the flow rate of the negative pressure pump based on the fed-back negative pressure value.

[0140] Working principle of rotary biopsy needle:

[0141] 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 cutting knife tube 103 is located in the puncture needle tube 102, and the outer sheath tube 101 is transported into the working channel of the endoscope. When the outer sheath tube 101 reaches the specified position, the outer sheath tube 101 is fixed to the endoscope through the endoscope fixing member 2.

[0142] During puncture, the sheath seat locking member 302 does not lock the sheath seat 301 and the proximal shell 4, and by pushing the proximal shell 4 toward the distal end, the puncture needle tube 102 and the rotary cutting knife tube 103 pass through the distal end of the outer sheath tube 101 and puncture the tissue. Please refer to Fig.15 During the puncture process, the distal end of the rotary cutting blade tube 103 is always located in the puncture needle tube 102. After the puncture is completed, the sheath seat 301 and the proximal housing 4 are locked by the sheath seat locking member 302.

[0143] After the puncture is completed, the puncture needle tube 102 is withdrawn through the puncture needle tube adjustment mechanism 6, the distal end of the puncture needle tube 102 is withdrawn, and the rotary cutter tube 103 is left, so that the distal end of the rotary cutter tube 103 extends from the distal end of the puncture needle tube 102. At this time, the metal wire spring tube 1033 of the rotary cutter tube 103 is completely located in the puncture needle tube 102, and the distal end of the puncture needle tube 102 is located in front of the outer sheath tube 101 and between the proximal and distal ends of the distal metal tube 1032 of the rotary cutter tube 103. Please refer to Fig.16 The rotary cutting blade tube 103 is driven by the rotary cutting blade tube transmission assembly 7 to perform rotary cutting sampling on the tissue.

[0144] After the sampling is completed, the rotary cutting blade 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 .

[0145] Although the present invention is disclosed as above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the scope defined by the claims.

Claims

1. A rotary biopsy needle with ablation function, characterized in that: It includes a distal pipeline part and a proximal handheld part, wherein the distal pipeline part includes an outer sheath tube, a puncture needle tube and a rotary cutting knife tube which are movably sleeved in sequence from the outside to the inside; The proximal handheld part includes a proximal shell and a puncture depth adjustment mechanism, and the puncture depth adjustment mechanism includes a sheath seat and a sheath seat locking piece. The sheath seat is a sleeve structure, and its distal end 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, and the proximal shell can move axially relative to the sheath seat and is locked with the sheath seat through the sheath seat locking piece. A conductive patch is provided in the sheath seat, which is in direct contact with the puncture needle tube. A high-frequency connection port is provided on the sheath seat, 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 to serve as a transmitting electrode.

2. The rotary biopsy needle according to claim 1, characterized in that: The outer sheath tube is made of polymer insulating material.

3. The rotary biopsy needle according to claim 1, characterized in that: The conductive patch is a metal spring, and one end of the metal spring is fixed in the sheath seat.

4. The rotary biopsy needle according to claim 1, characterized in that: The proximal handheld part also includes a puncture needle tube adjustment mechanism and a rotary cutter tube transmission assembly. The puncture needle tube is installed in the proximal housing through the puncture needle tube adjustment mechanism, and the puncture needle tube is moved axially by driving the puncture needle tube adjustment mechanism; the rotary cutter tube is installed in the proximal housing through the rotary cutter tube transmission assembly, and the rotary cutter tube is driven to rotate circumferentially and move axially. 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 piece does not lock the sheath seat and the proximal shell, and by pushing the proximal shell toward the distal end, the proximal shell drives the puncture needle tube and the rotary cutter tube to pass through the distal end of the outer sheath tube and puncture the tissue. 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; After the sampling is completed, the rotary cutting knife tube is withdrawn, and the distal end of the puncture needle tube is extended from the distal end of the outer sheath tube to ablate the tissue.

5. The rotary biopsy needle according to claim 4, characterized in that: The puncture needle tube adjustment mechanism includes a puncture needle tube sleeve and an elastic locking structure, wherein the puncture needle tube sleeve is located in the proximal shell and is fixedly sleeved on the puncture needle tube; the elastic locking structure is provided on at least one outer side of the puncture needle tube sleeve, and a puncture needle tube adjustment groove is axially opened on at least one side of the tube wall of the proximal shell, and the elastic locking structure passes through the puncture needle tube adjustment groove; the elastic locking structure includes an integrally arranged button and at least one limiting column, and a plurality of limiting grooves are spaced apart on at least one side of the groove wall of the puncture needle tube adjustment groove. In a natural state, the limiting column is located in the limiting groove, and by pressing the button, the limiting column is separated from the limiting groove to the proximal shell, so that the puncture needle tube can follow the button to move axially along the puncture needle tube adjustment groove.

6. The rotary biopsy needle according to claim 5, characterized in that: A mounting hole is axially provided at the center of the puncture needle tube sleeve, and the puncture needle tube passes through the mounting hole and is fixed to the mounting hole; a hollow area is provided at the proximal end of at least one side tube wall of the puncture needle tube sleeve located at the mounting hole, and an elastic strip is provided on the outer side of the hollow area, the elastic strip is axially arranged along the puncture needle tube sleeve, and the distal end of the elastic strip is fixedly connected to the puncture needle tube sleeve, the elastic locking structure is fixed to the proximal end of the elastic strip, and the button is pressed, and the limit column follows the proximal end of the elastic strip to move toward the hollow area, so that the limit column disengages from the limit slot.

7. The rotary biopsy needle according to claim 4, characterized in that: The rotary cutter tube transmission assembly includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism. The rotary cutter tube is driven to rotate by driving the circumferential rotation transmission mechanism, so that the rotary cutter tube cuts the tissue; and the rotary cutter tube is driven to move axially by driving the axial movement transmission mechanism to adjust the cutting depth of the rotary cutter tube.

8. The rotary biopsy needle according to claim 7, characterized in that: The circumferential rotation transmission mechanism comprises a core shaft assembly and a rotating shaft located in the proximal housing, the core shaft assembly is fixedly sleeved on the rotary cutter tube, the rotating shaft 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 shaft, and 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, wherein the screw sleeve is rotatably arranged in the proximal housing and is threadedly meshed with the transmission screw for transmission; the screw sleeve is coaxially fixedly connected with a stroke gear, and the stroke gear is driven by a stroke drive motor to perform rotational motion, and the stroke gear drives the screw sleeve to rotate, and the rotational motion of the screw sleeve is converted into axial movement of the transmission screw; The transmission screw is sleeved on the rotating shaft and is relatively fixed to the core shaft assembly in the axial direction and is relatively rotatably connected in the circumferential direction.

9. The rotary biopsy needle according to claim 8, characterized in that: The spindle assembly comprises a fixed tube and an inner knife sleeve, wherein the fixed tube is fixedly sleeved on the rotary cutter tube, the inner knife sleeve is fixedly sleeved on the fixed tube, the rotating shaft is sleeved on the inner knife sleeve, and the rotating shaft and the inner knife sleeve are connected by sliding in the axial direction and fixedly connected in the circumferential direction via an axial protrusion inserted into an axial guide groove; The inner knife sleeve and the transmission screw are connected in a circumferential rotational direction and fixedly connected in an axial direction by inserting an annular limiting clamping piece provided circumferentially into an annular limiting clamping groove.

10. The rotary biopsy needle according to claim 8, characterized in that: A guide rail is also provided on the inner wall of the proximal shell, and the transmission screw is slidably arranged on the guide rail.

11. The rotary biopsy needle according to claim 1, characterized in that: The outer sheath is also provided with an endoscope fixing part, which includes a locking sleeve and a locking part. The locking sleeve includes an integrally arranged 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 part.

12. The rotary biopsy needle according to claim 1, characterized in that: The proximal end of the proximal shell is provided with a negative pressure interface for connecting 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 with the negative pressure interface. The proximal end of the rotary cutter tube is inserted into the connecting sleeve from the distal end of the connecting sleeve, and a dynamic seal is performed between the connecting sleeve and the rotary cutter tube through a dynamic seal.

13. A rotary biopsy system with ablation function, characterized in that: It comprises the rotary biopsy needle, negative pressure electrode and host as described in any one of claims 1 to 12. During ablation, the high-frequency connection port is electrically connected to the host through a first connection line, the negative pressure electrode is electrically connected to the host through a second connection 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 biopsy system according to claim 13, characterized in that: It also includes a foot switch, which is electrically connected to the host.

Images