A rotational biopsy needle with ablation function and biopsy system

Abstract

The application provides a rotary biopsy needle with ablation function and a biopsy system, wherein the rotary biopsy needle 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 which are movably sleeved in sequence; 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 in a sleeve structure, the distal end of the sheath seat is fixedly sleeved at the proximal end of the outer sheath tube, the proximal end of the puncture needle tube passes through the sheath seat to 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; 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 is connected with the conductive patch; during ablation, the distal end of the puncture needle tube is extended from the distal end of the outer sheath tube to the tissue and serves as a transmitting 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 an ablation function. Background Art

[0002] Cancer, due to its high mortality and morbidity rates, has become a focal point of public concern in recent years. With advances in medicine, a growing number of cancer treatment options are available, and patient survival is gradually increasing. Among these, respiratory interventional therapy, a minimally invasive treatment technique that has gained increasing attention in recent years, particularly bronchoscopic interventional therapy, has become an essential diagnostic and treatment option for airway and lung diseases.

[0003] Tumor ablation has the advantages of rapid heating, short operation time, and large ablation range, and is being 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 cancer cells in the lesion, thereby inhibiting tumor growth and shrinking the tumor, thereby preventing the tumor from continuing to grow and prolonging the patient's survival time.

[0004] Before ablation surgery, a biopsy is often performed to obtain samples from the lesion. Endoscopic ultrasound-guided transbronchial needle aspiration biopsy is a minimally invasive technique that uses real-time ultrasound guidance to perform biopsies of the lungs, peripulmonary tissues, and lymph nodes. Its advantages include avoiding vital areas such as large blood vessels and nerves while minimizing the risk of major bleeding and improving sample collection accuracy. It is also minimally invasive, simple, and relatively safe.

[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 using other equipment or devices. Switching equipment back and forth is complicated and costly. Summary of the Invention

[0006] To solve the above technical problems, an embodiment of the present invention provides a rotary biopsy needle with an ablation function, comprising a distal tubing portion and a proximal handheld portion, wherein the distal tubing portion comprises an outer sheath, a puncture needle tube, and a rotary cutting blade tube that are movably arranged in sequence from the outside to the inside;

[0007] The proximal handheld portion includes a proximal shell and a puncture depth adjustment mechanism, the puncture depth adjustment mechanism includes a sheath seat and a sheath seat locking piece, 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 move axially relative to the sheath seat, and is locked with the sheath seat by 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 an emitting electrode.

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

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

[0011] Optionally, the proximal handheld portion further includes a puncture needle tube adjustment mechanism and a rotary cutter tube transmission assembly, wherein the puncture needle tube is installed in the proximal housing via 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 via 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 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 cutter 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 groove wall of the puncture needle tube adjustment groove. In a natural state, the limiting column is located in the limiting slot, and by pressing the button, the limiting column is disengaged from the limiting slot to the proximal shell, 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 the tube wall of at least one side of the puncture needle tube sleeve located at the mounting hole, and an elastic strip is provided on the outside of the hollow area, and the elastic strip is arranged axially along the puncture needle tube sleeve, and the distal end of the elastic strip is fixedly connected to the puncture needle tube sleeve, and the elastic locking structure is fixed to the proximal end of the elastic strip, and when the button is pressed, the limit column follows the proximal end of the elastic strip to move toward the hollow area, so that the limit column disengages from the limit slot.

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

[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 rotary 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, the screw sleeve is rotatably arranged in the proximal housing and is threadably engaged with the transmission screw for transmission; the screw sleeve is coaxially fixedly connected to a travel gear, the travel gear is driven to rotate by a travel drive motor, the travel gear drives the screw sleeve to rotate, and the rotational motion of the screw sleeve is converted into axial movement of the transmission screw;

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

[0019] Optionally, the core shaft assembly includes a fixed tube and an inner knife sleeve, 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 an axial protrusion inserted into an axial guide groove to achieve axial sliding connection and circumferential fixed connection;

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

[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 part is further provided on the outer sheath tube, and the endoscope fixing part includes a locking sleeve and a locking part. The locking sleeve includes an integral connecting part and a locking part. The connecting part is used to be fixedly connected to the endoscope, and the locking part is movably sleeved on the outer sheath tube, and the locking part can be locked on the outer sheath tube through the locking part.

[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 host described in the above embodiment. During ablation, the high-frequency connection port is electrically connected to the host through a first connection line, and 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.

[0025] Optionally, the rotary biopsy system further includes a foot switch, which 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 ablate the diseased tissue after sampling.

[0028] 2. The present invention provides a negative pressure interface at the proximal end of the proximal housing of the biopsy needle. The negative pressure interface is sealed and connected to a connecting sleeve. The connecting sleeve is arranged in the proximal housing. The rotary cutter tube is inserted into the connecting sleeve and is dynamically sealed with the connecting sleeve by a dynamic seal. Therefore, the sealing problem of the rotary cutter tube is solved, and negative pressure suction of the rotary cutter biopsy needle is realized.

[0029] 3. In the present invention, the distal tubing portion includes, from outside to inside, an outer sheath, a puncture needle, and a rotary cutter. Before puncture, the distal end of the puncture needle is located within the outer sheath, and the distal end of the rotary cutter is located within the puncture needle. During puncture, the puncture needle and rotary cutter together penetrate the tissue from the distal end of the outer sheath, and during the puncture process, the distal end of the rotary cutter remains within the puncture needle. After puncture, the rotary cutter extends from the distal end of the puncture needle to sample the tissue by rotary cutting. Because the distal end of the rotary cutter is located within the puncture needle during puncture, the rotary cutter can penetrate the human tissue along with the puncture needle, ensuring the smoothness of the outer surface of the puncture needle and making puncture easier.

[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 cutter tube. Therefore, before puncture, the distal end of the puncture needle tube is placed in the outer sheath, and the distal end of the rotary cutter tube is placed in the puncture needle tube. During the process of transporting the outer sheath into the working channel of the endoscope, the puncture needle or the rotary cutter is prevented from damaging the endoscope.

[0031] 5. Negative pressure suction can increase the sample volume of the rotary cutter tube. During sampling, as the amount of tissue inside the rotary cutter tube increases, the friction between the tissue and the tube increases. This frictional resistance prevents the sample from entering deeper into the tube, preventing the sample from increasing. The suction provided by negative pressure can overcome this frictional resistance, drawing more sample tissue into the lumen of the rotary cutter tube and increasing the sample 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 are relatively large after assembly. If the traditional fixing method is adopted, the difficulty of moving the endoscope and operating the endoscope will be greatly increased after the proximal housing and the endoscope are fixed. The present invention directly fixes the outer sheath to the endoscope through the endoscope fixing part on the outer sheath, 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 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 following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

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

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

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

[0038] Figure 4 for Figure 3 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 provided in one embodiment of the present invention after puncture is completed;

[0041] Figure 7 A schematic structural diagram of an endoscope fixing member provided in one 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] Figure 9 An end view of a puncture needle tube adjustment mechanism provided in one embodiment of the present invention;

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

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

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

[0047] Figure 13 A schematic structural diagram of a rotary cutter tube transmission assembly provided in one embodiment of the present invention;

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

[0049] Figure 15 A schematic diagram showing the positions of the outer sheath, puncture needle, and rotary cutting blade during puncture according to one embodiment of the present invention;

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

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

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

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

[0054] Existing biopsy needles only have the function of sampling. They cannot stop bleeding tissue during sampling, nor can they ablate diseased tissue after sampling.

[0055] In order to solve the above technical problems, the present invention provides a rotary biopsy needle with ablation function, comprising a distal tubing portion and a proximal handheld portion, wherein the distal tubing portion comprises an outer sheath tube, a puncture needle tube, and a rotary cutting blade tube, which are movably sheathed from the outside to the inside.

[0056] The proximal handheld portion includes a proximal shell and a puncture depth adjustment mechanism, the puncture depth adjustment mechanism includes a sheath seat and a sheath seat locking piece, 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 move axially relative to the sheath seat, and is locked with the sheath seat by 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 an emitting 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 restrict the applicable location of the rotary biopsy needle. Therefore, the present invention does not restrict the specific location of the negative pressure electrode on the patient, and can be set according to specific usage requirements. For example, when performing a transbronchial needle aspiration biopsy with a rotary biopsy needle under endoscopic ultrasound guidance, the negative pressure electrode can be placed on the patient's buttocks.

[0060] In order to facilitate the operator's operation, the rotary biopsy system is characterized in that it also includes 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] To make the above-mentioned objects, features, and beneficial effects of the present invention more clearly understood, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts shall fall within the scope of protection of the present invention.

[0063] Please refer to Figures 1 to 4The present invention provides a rotary biopsy needle, comprising a distal pipeline portion 1 and a proximal hand-held portion, wherein the distal pipeline portion 1 comprises an outer sheath tube 101, a puncture needle tube 102 and a rotary cutting knife tube 103 which are movably sleeved from the outside to the 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. 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 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. By driving the puncture needle tube adjustment mechanism 6, the puncture needle tube moves axially; the rotary cutter tube 103 is installed in the proximal shell 4 through the rotary cutter tube transmission assembly 7. By driving the rotary cutter tube transmission assembly 7, the rotary cutter tube 103 rotates circumferentially and moves axially. The proximal shell 4 can move axially relative to the sheath seat 301, and the sheath seat 301 can be locked to the proximal shell 4 through the sheath seat locking piece 302.

[0065] A conductive patch 304 is provided 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 provided 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. The elastic force of the metal shrapnel ensures that the metal shrapnel is always in direct contact with the puncture needle tube 102. The outer sheath tube 101 is made of a polymer insulating material. The purpose is to use the needle tip of the puncture needle tube 102 (i.e., the distal end of the puncture needle tube 102) that extends from the distal end of the outer sheath tube 101 and is 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 cutter 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 cutter tube 103 are made to pass through the distal end of the outer sheath tube 101 together to puncture the tissue, and during the puncture process, the distal end of the rotary cutter tube 103 is always located in the puncture needle tube 102; after the puncture is completed, the rotary cutter tube 103 extends from the distal end of the puncture needle tube 102 to sample by rotary cutting the tissue; 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.

[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 the human tissue together with the puncture needle tube 102, 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 impose any restrictions on the material of the outer sheath 101. Smooth polymer insulating materials such as PTFE and PEEK are preferred to prevent damage to the endoscope during passage through the endoscope's working channel, ensuring delivery performance. Furthermore, during ablation, the entire portion of the puncture needle 102, excluding the needle tip, is insulated to prevent damage to the endoscope and other human tissue.

[0072] Traditional biopsy needles are typically secured to the endoscope via a proximal housing and operated by the endoscope operator. However, because rotary biopsy needles incorporate a motor, the motor handle and proximal housing are relatively heavy when assembled. Using traditional securing methods, securing the proximal housing to the endoscope significantly increases the difficulty for the endoscope operator in manipulating the needle and operating the needle.

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

[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. 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 manner in which the connection portion 2011 is fixedly connected to the endoscope, and for example, a threaded connection, a clamping connection, or other detachable fixed connection methods may be used. Furthermore, this embodiment does not impose any specific restrictions on the manner in which the locking member 202 locks the locking portion 2013 to the outer sheath 101, and for example, a nut or a locking screw may be used for locking.

[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 and the second Luer connector are cooperatively connected.

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

[0078] The locking portion 2013 may be an elastic member such as a silicone structure, and the first locking cap squeezes the elastic member to enhance the fixing effect. A plurality of pressure strips may be spaced apart at the proximal end of the locking portion 2013, and the pressure strips are movably positioned over the outer sheath 101. The first locking cap is designed to have a tapered structure that gradually tapers from the distal end to the proximal end. When the first locking cap is tightened with the locking portion 2013, the pressure strips are contracted and clamped to the outer sheath 101, thereby achieving a fixed connection between the outer sheath 101 and the endoscope.

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

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

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

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

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

[0084] The proximal end of the sheath seat 301 can be an elastic member, such as a silicone structure, and the second locking cap squeezes the elastic member to enhance the fixation effect. The proximal end of the sheath seat 301 is not limited to an elastic member. A plurality of beadings can also be provided at intervals. These beadings are movably mounted on the proximal housing 4. The second locking cap is designed to have a tapered structure that gradually tapers from the distal end to the proximal end. When the second locking cap is tightened with the sheath seat 301, the beadings are contracted and clamped to the proximal housing 4, achieving a locked connection between the sheath seat 301 and the proximal housing 4.

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

[0086] When the proximal housing 4 is pushed quickly toward the distal end, an annular protrusion 401 is provided on the outer side of the proximal housing 4 to facilitate manual operation of the proximal housing 4. By pushing the annular protrusion 401, the proximal housing 4 can be pushed quickly toward the distal end.

[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 a locking cap structure, and can also be a threaded fastener. Specifically, a threaded hole is provided on one side wall of the sheath seat 301, and the sheath seat locking member 302 is a threaded fastener adapted to the threaded hole. The first end of the threaded fastener passes through the threaded hole into the sheath seat, and the second end is located outside the sheath seat 301. The threaded fastener is tightened by manually tightening the second end of the threaded fastener so that the first end of the threaded fastener abuts against the proximal housing 4, thereby fixing the proximal housing 4 to the sheath seat 301. The threaded fastener is a structure such as a locking screw.

[0089] The puncture needle tube 102, serving as the intermediate layer of the distal tubing of the biopsy needle, is made of metal, such as 304L or 316L stainless steel. The needle thickness should be as low as possible, typically less than 0.1 mm, to increase the internal lumen to accommodate the cutter tube. The puncture needle tube 102 has a needle tip, which facilitates puncture and breakthrough.

[0090] To enhance ultrasound imaging and facilitate visualization of the position of the puncture needle 102, a first ultrasound-reflecting region is provided on the outer surface of the puncture needle 102 near its needle tip 1021. The first ultrasound-reflecting region is required to have an uneven texture. The present invention does not impose any specific restrictions on the shape of the texture in the first ultrasound-reflecting region. For example, the outer surface of the puncture needle 102 may be roughened by processes such as threading or dotting to enhance ultrasound imaging of the puncture needle 102.

[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 Figure 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 spaced apart on at least one side wall of the puncture needle tube adjustment slot. In a natural state, the limiting column 6012 is located in the limiting slot. By pressing the button 6011, the limiting column 6012 is disengaged from the limiting slot to the proximal shell 4, thereby enabling the puncture needle tube 102 to follow the button 6011 and move axially along the puncture needle tube adjustment slot.

[0093] In this embodiment, when the button 6011 is pressed, the limiting post 6012 disengages from the limiting slot, and the puncture needle tube 102 can follow the button 6011 and move freely in the axial direction along the puncture needle tube adjustment slot, thereby adjusting the axial position of the puncture needle tube 102. When the button is released, the button returns to its original position under the action of elasticity, and the limiting post 6012 inserts into the limiting slot of the puncture needle tube adjustment slot, thereby fixing the puncture needle tube 102.

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

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

[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 the tube wall of at least one side of the mounting hole 6021 of the puncture needle tube sleeve 602, and an elastic pressure strip 6013 is provided on the outside of the hollow area 6022. The elastic pressure strip 6013 is arranged along the axial direction of the puncture needle tube sleeve 602, and the distal end of the elastic pressure strip 6013 is fixedly connected to the puncture needle tube sleeve 602, and the elastic locking structure 601 is fixed to the proximal end of the elastic pressure strip 6013. When the button 6011 is pressed, the limiting column 6012 follows the proximal end of the elastic pressure strip 6013 to move toward the hollow area 6022, so that the limiting column 6012 disengages from the limiting slot.

[0098] The rotary cutting blade 103 is a tubular structure that forms the innermost layer of the distal tubing of the biopsy needle. The distal end of the rotary cutting blade 103 includes an annular blade that ensures smooth tissue incision. The annular blade preferably has a flat edge to ensure the integrity of the tissue after rotary cutting, preventing it from being crushed and affecting pathological analysis.

[0099] As an example, please refer to Figure 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 corners of the distal end surface of the rotary cutter tube 103 . The outer blade edge 1031 is used for cutting low-density tissue.

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

[0101] In a specific embodiment, please refer to Figure 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. Both the distal metal tube 1032 and the proximal metal tube 1035 are metal tubes, such as stainless steel tubes. The distal end of the distal metal tube 1032 is an annular blade. The metal structure of the distal metal tube 1032 ensures that the rotary cutter tube 1033 can smoothly cut tissue. The metal structure of the proximal metal tube 1035 facilitates assembly and fixation. The wire spring tube 1033 is a hollow tube woven from stainless steel or nickel-titanium wire. When bent, the wire spring tube 1033 can flexibly transmit rotational speed and torque, effectively reducing vibration. The proximal end of the distal metal tube 1032 and the distal end of the wire spring tube 1033 are connected by end-face welding to ensure that the outer diameter and inner diameter of the distal metal tube 1032 and the wire spring tube 1033 are substantially consistent.

[0102] A thin-walled polymer sealing tube 1034, such as a thin-walled heat-shrink tubing, is attached to the outside of the rotary cutter tube 103 via a heat-shrink process. This seals the rotary cutter tube 103, allowing the internal cavity to transmit negative or positive pressure, preventing leakage at welds and gaps between braided tubes. Furthermore, the thin-walled heat-shrink tubing reduces friction between the rotary cutter tube and the puncture needle during rotation, preventing wear of the braided wire of the rotary cutter tube.

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

[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 achieve flexible rotation of the rotary cutter tube 103, the rotary cutter tube 103 uses a flexible rotary cutter shaft of a wire spring tube 1033 to achieve flexible transmission of torque and speed. However, without rigid support, the wire spring tube 1033 is very prone to shaking, affecting the sampling effect. In the present invention, the puncture needle tube 102 is sheathed outside the rotary cutter tube 103. The inner diameter of the puncture needle tube 102 is slightly larger than the outer diameter of the rotary cutter tube 103. Therefore, the puncture needle tube 102 can play a role similar to a sliding bearing. When the rotary cutter tube 103 rotates, the rotary cutter tube 103 rotates within the inner cavity of the puncture needle tube 102, preventing the rotary cutter tube 103 from shaking, thereby providing rigid support for the rotary cutter tube 103 and improving the stability of the rotary cutter tube 103 during rotation.

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

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

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

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

[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 the tissue.

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

[0112] The rotary cutter tube transmission assembly 7 can both drive the rotary cutter tube 103 to rotate and cut tissue, and can also adjust the axial stroke of the rotary cutter tube 103 to adjust the cutting depth of the rotary cutter tube 103. In one embodiment, the rotary cutter tube transmission assembly 7 includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism, both of which are connected to the rotary cutter tube 103. The circumferential rotation transmission mechanism drives the rotary cutter tube 103 to rotate, causing the rotary cutter tube 103 to cut tissue; the axial movement transmission mechanism drives the rotary cutter tube 103 to move axially, thereby adjusting the axial stroke of the rotary cutter tube 103 and, in turn, the cutting depth of the rotary cutter tube 103.

[0113] As an example, please refer to Figure 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, and 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, and the rotating gear 701 is driven by a rotary 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 in an axial sliding manner and fixedly connected in a circumferential direction by inserting an axial protrusion into an axial guide groove.

[0116] In one specific implementation, the inner wall of the rotating shaft 702 is provided with a plurality of protrusions spaced circumferentially, each of which is arranged axially along the rotating shaft 702. The outer wall of the inner blade sleeve 706 is provided with a plurality of guide grooves spaced circumferentially, each of which is adapted to mate with the protrusions. These guide grooves are also arranged axially along the inner blade sleeve 706. By inserting the protrusions into the guide grooves, the rotating shaft 702 and the inner blade sleeve 706 are both axially slidably connected and circumferentially fixedly connected. This means that the rotating shaft 702 and the inner blade sleeve 706 can both slide relative to each other axially and rotate synchronously circumferentially. Alternatively, the protrusions can be provided on the outer wall of the inner blade sleeve 706, and the guide grooves can be provided on the inner wall of the rotating shaft 702. This embodiment does not impose any specific limitations on this.

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

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

[0119] The screw sleeve 703 only rotates within the proximal housing 4 and does not move axially. To limit axial movement of the screw sleeve 703 within the proximal housing 4, positioning baffles are provided at the proximal and distal ends of the screw sleeve 703 and the proximal housing 4. The purpose is to confine the screw sleeve 703 between the two positioning baffles to prevent it from moving axially.

[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 is relatively rotatable in the circumferential direction.

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

[0122] In one specific implementation, an annular limiting groove 7061 is provided on the outer circumference of the inner blade sleeve 706, and an annular limiting clamp 705 is provided on the inner circumference of the drive screw 704, which is adapted to the annular limiting groove 7061. The annular limiting clamp 705 is inserted into the annular limiting groove 7061 to achieve a circumferential rotational connection between the drive screw 704 and the inner blade sleeve 706, and an axially fixed connection, that is, the inner blade sleeve 706 and the drive screw 704 can rotate relative to each other but cannot produce relative displacement in the axial direction. Of course, the annular limiting groove can also be provided on the inner circumference of the drive screw 704, and the annular limiting clamp adapted to the annular limiting groove is provided on the outer circumference of the inner blade sleeve 706. This embodiment does not impose specific limitations on this.

[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 Figure 13 The proximal end surface of the proximal housing 4 is provided with a negative pressure interface 401 for communicating with a negative pressure device. A connecting sleeve 9 is provided within the proximal housing 4. The proximal end of the connecting sleeve 9 is in sealed communication with the negative pressure interface 401. The proximal end of the rotary cutter tube 103 is inserted into the connecting sleeve 9 from the distal end of the connecting sleeve 9. A dynamic seal 10 is formed between the connecting sleeve 9 and the rotary cutter tube 103. When the rotary cutter tube 103 moves forward, it moves from the proximal end to the distal end. A portion of the rotary cutter tube 103 is always located within the connecting sleeve 9 of the rotary cutter tube 103 and contacts the dynamic seal 10, forming a dynamic seal.

[0125] In the initial position, the present invention does not impose a limit on the length of the rotary cutter tube 103 within the connecting sleeve 9. Furthermore, when the rotary cutter tube 103 moves from the proximal end to the distal end to the maximum cutting depth, the length of the rotary cutter tube 103 within the connecting sleeve 9 is also not limited and can be set according to actual usage requirements. To prevent the rotary cutter tube 103 from escaping from the connecting sleeve 9, as an example, in the initial position, the length of the rotary cutter tube 103 within 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 Variseal seal or a silicone seal ring.

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

[0129] In another specific embodiment, the sealing ring is fixed on the distal end face of the connecting sleeve 9, and the proximal end of the rotary cutter tube 103 is inserted into the sealing ring and dynamically sealed with the sealing ring. Please refer to Figure 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 fixation, 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 via a Luer connector, and the other end of the negative pressure pipeline is connected to the negative pressure device. After the Luer connector is tightened, the negative pressure can be transmitted from the negative pressure device to the distal end of the rotary cutter tube 103.

[0133] Since the rotary cutter tube 103 is a tubular structure with an annular blade at its distal end, after sampling, the tissue at the blade edge needs to be severed to complete the sampling. Therefore, during sampling, the negative pressure device applies negative pressure suction to the rotary cutter tube 103 through the negative pressure interface 401. The negative pressure suction can increase the breaking force of the rotary cutter tube 103 during retreat, ensuring that the tissue can be successfully severed.

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

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

[0136] As an embodiment, the negative pressure interface 401 is further connected to a three-way connector, which includes a first interface, a second interface, and a third interface. The first interface is used to communicate with the negative pressure interface 401, the second interface is used to connect to the negative pressure device, and the third interface is used to connect to the syringe. The three-way connector is provided with an adjustment switch, and the adjustment switch switches the first interface's access to the second and third interfaces. For example, when the adjustment switch is in position I, the negative pressure suction of the negative pressure device can be transmitted to the distal end of the rotary cutter tube 103, achieving tissue absorption; when the adjustment switch is in position II, the syringe can flush and sample the tissue within the rotary cutter tube 103 to ensure tissue integrity.

[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 to illustrate 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 based on the feedback negative pressure value by adjusting the flow rate of the negative pressure pump.

[0140] Working principle of rotary biopsy needle:

[0141] Please refer to Figure 14 Before puncture, the distal end of the puncture needle tube 102 is located inside the outer sheath tube 101, and the distal end of the rotary cutter tube 103 is located inside the puncture needle tube 102. The outer sheath tube 101 is transported into the working channel of the endoscope. When the outer sheath tube 101 reaches the designated position, the outer sheath tube 101 is fixed to the endoscope through the endoscope fixing member 2.

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

[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 Figure 16 The rotary cutting blade tube 103 is driven by the rotary cutting blade tube transmission assembly 7 to perform rotary cutting and sampling on the tissue.

[0144] After the sampling is completed, the rotary cutting 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. Figure 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 scope of protection of the present invention should be based on the scope defined by the claims.

Claims

1. A rotary biopsy needle with ablation function, characterized in that: It includes a distal tubing part and a proximal handheld part, wherein the distal tubing 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 portion includes a proximal shell, a puncture depth adjustment mechanism, a puncture needle tube adjustment mechanism and a rotary cutter tube transmission assembly, the puncture depth adjustment mechanism includes a sheath seat and a sheath seat locking piece, 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 move axially relative to the sheath seat, and is locked with the sheath seat by the sheath seat locking piece; A conductive patch is provided in the sheath seat, the conductive patch is in direct contact with the puncture needle tube, and a high-frequency connection port is provided on the sheath seat, the high-frequency connection port 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; The conductive patch is a metal spring, one end of which is fixed in the sheath seat; 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 member 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 and sampling on the tissue; After the sampling is completed, the rotary cutter 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.

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

3. The rotary biopsy needle according to claim 1, characterized in that: The puncture needle tube adjustment mechanism includes a puncture needle tube sleeve and an elastic locking structure, wherein the puncture needle tube sleeve is located in the proximal shell and is fixedly sleeved on the puncture needle tube; the elastic locking structure is provided on at least one outer side of the puncture needle tube sleeve, and a puncture needle tube adjustment groove is axially opened on at least one side of the tube wall of the proximal shell, and the elastic locking structure passes through the puncture needle tube adjustment groove; the elastic locking structure includes an integrally arranged button and at least one limiting column, and a plurality of limiting slots are spaced apart on at least one side groove wall of the puncture needle tube adjustment groove. In a natural state, the limiting column is located in the limiting slot, and by pressing the button, the limiting column is disengaged from the limiting slot to the proximal shell, thereby enabling the puncture needle tube to follow the button and move axially along the puncture needle tube adjustment slot.

4. The rotary biopsy needle according to claim 3, characterized in that: A mounting hole is axially provided at the center of the puncture needle tube sleeve, and the puncture needle tube passes through the mounting hole and is fixed to the mounting hole; a hollow area is provided at the proximal end of the tube wall of at least one side of the puncture needle tube sleeve located at the mounting hole, and an elastic strip is provided on the outside of the hollow area, and the elastic strip is arranged along the axial direction of the puncture needle tube sleeve, and the distal end of the elastic strip is fixedly connected to the puncture needle tube sleeve, and the elastic locking structure is fixed to the proximal end of the elastic strip, and when the button is pressed, the limit column follows the proximal end of the elastic strip to move toward the hollow area, so that the limit column disengages from the limit slot.

5. The rotary biopsy needle according to claim 1, characterized in that: The rotary cutter tube transmission assembly includes a circumferential rotation transmission mechanism and an axial movement transmission mechanism. By driving the circumferential rotation transmission mechanism, the rotary cutter tube is driven to rotate, so that the rotary cutter tube cuts the tissue; by driving the axial movement transmission mechanism, the rotary cutter tube is driven to move axially, so as to adjust the cutting depth of the rotary cutter tube.

6. The rotary biopsy needle according to claim 5, characterized in that: 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 rotary 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 rotatably arranged in the proximal housing and is threadably engaged with the transmission screw for transmission; the screw sleeve is coaxially fixedly connected to a travel gear, the travel gear is driven to rotate by a travel drive motor, the travel gear drives the screw sleeve to rotate, and the rotational motion of the screw sleeve is converted into axial movement of the transmission screw; The transmission screw is externally mounted on the rotating shaft and is relatively fixed to the core shaft assembly in the axial direction and is connected to rotate relatively in the circumferential direction.

7. The rotary biopsy needle according to claim 6, characterized in that: The core shaft assembly includes a fixed tube and an inner knife sleeve, the fixed tube is fixedly outer-circuited on the rotary cutter tube, the inner knife sleeve is fixedly outer-circuited on the fixed tube, the rotating shaft is outer-circuited 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; The inner cutter sleeve and the transmission screw are connected in a circumferential rotation direction and fixedly connected in an axial direction by inserting an annular limiting clamping piece provided circumferentially into an annular limiting clamping groove.

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

9. The rotary biopsy needle according to claim 1, characterized in that: An endoscope fixing part is also provided on the outer sheath tube, and the endoscope fixing part includes a locking sleeve and a locking part. The locking sleeve includes an integral connecting part and a locking part. The connecting part is used to be fixedly connected to the endoscope, and the locking part is movably sleeved on the outer sheath tube, and the locking part can be locked on the outer sheath tube through the locking part.

10. The rotary biopsy needle according to claim 1, wherein: The proximal end of the proximal shell is provided with a negative pressure interface for communicating with a negative pressure device. A connecting sleeve is provided in the proximal shell. The proximal end of the connecting sleeve is sealed and connected to the negative pressure interface. The proximal end of the rotary cutter tube is inserted into the connecting sleeve from the distal end of the connecting sleeve, and a dynamic seal is performed between the connecting sleeve and the rotary cutter tube through a dynamic seal.

11. A rotary biopsy system with ablation function, characterized in that: The device comprises the rotary biopsy needle, negative pressure electrode and host according to any one of claims 1 to 10. During ablation, the high-frequency connection port is electrically connected to the host via a first connection line, the negative pressure electrode is electrically connected to the host via 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.

12. The rotary biopsy system according to claim 11, wherein: It also includes a foot switch, which is electrically connected to the host.

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