Angle adjustment mechanism, biopsy device, and operating method

Abstract

Disclosed are an angle adjustment mechanism, a biopsy device, and an operating method. The angle adjustment mechanism (210) comprises: a first tube (1), a second tube (2), and a control member (3). The control member (3) passes through the first tube (1) and the second tube (2). A distal end of the control member (3) is connected to an end tool (220), and is configured to drive the end tool (220) and the second tube (2) to rotate relative to the first tube (1), and drive the end tool (220) to deviate from a rotation axis of the second tube (2) relative to the second tube (2). The biopsy device (100) comprises the first tube (1), the second tube (2), and the control member (3). The control member (3) comprises two control wires (311, 312) intersecting at a first position, and a limiting structure (53). The limiting structure (53) is located on a proximal side of the first position and between the two control wires (311, 312), and is configured to abut against the two control wires (311, 312).

Description

Angle adjustment mechanism, biopsy device and operating method

[0001] Related applications

[0002] This application claims priority to Chinese patent applications filed on November 20, 2024, with application number 202411666024.0, entitled "Angle Adjustment Mechanism, Biopsy Device and Operating Method", and on April 30, 2025, with application number 202520879915.8, entitled "A Biopsy Forceps", the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to the field of medical device technology, and in particular to angle adjustment mechanisms, biopsy devices, and operating methods. Background Technology

[0004] Disposable biopsy forceps are primarily medical devices used under endoscopy. A disposable biopsy forceps consists of a handle assembly, a sheath assembly, and a forceps head assembly. The forceps head assembly is connected to the handle assembly via the sheath assembly. The forceps head assembly may include a cup holder and a forceps cup that are rotatably connected. The sheath assembly transmits power from the handle assembly to the forceps cup of the forceps head assembly, controlling the movement of the forceps cup relative to the cup holder.

[0005] Due to structural limitations, the operation is usually carried out by controlling the distal end instrument by operating the handle assembly at the proximal end. The long control distance makes it inconvenient to operate the forceps assembly. Therefore, existing biopsy forceps can usually only perform single opening, closing or rotation operations. However, in actual application scenarios, it is often encountered that the target is not facing the forceps head. A single operation is not enough to align the forceps head with the target, making it difficult to complete the sampling.

[0006] Of course, this is not limited to biopsy forceps; gripping forceps, electrocoagulation forceps, clamps, and other instruments all face this problem. Summary of the Invention

[0007] According to various embodiments of this application, an angle adjustment mechanism, a biopsy device, and an operating method are provided.

[0008] On one hand, this application provides an angle adjustment mechanism for controlling an end effector. The angle adjustment mechanism includes: a first tube, including a first connecting portion and a first tube segment; a second tube, including a second connecting portion and a second tube segment, the second tube segment being rotatably connected to the first tube segment, the second connecting portion being used to connect the end effector; and a control member, passing through the first tube and the second tube, the distal end of the control member being connected to the end effector, the control member being used to drive the end effector and the second tube to rotate relative to the first tube, and the control member being used to drive the end effector to deviate relative to the second tube from the rotation axis of the second tube.

[0009] Secondly, this application provides a biopsy device, which includes: an end instrument including at least two clamp cups; and the aforementioned angle adjustment mechanism, wherein the two clamp cups are rotatably connected to the second connecting portion and the two clamp cups have an open state and a clamping state; and the distal ends of the two control wires of the control member are respectively connected to the two clamp cups to control the opening, closing, rotation and lateral rotation of the clamp cups.

[0010] Thirdly, this application provides a method for operating the aforementioned angle adjustment mechanism, the method comprising: driving the end device and the second tube to rotate relative to the first tube about a rotation axis by means of a rotation control member; causing the end device to rotate about a side rotation axis arranged at an angle to the rotation axis; and controlling the end device to perform working actions by means of the control member.

[0011] Fourthly, this application provides a biopsy device comprising: an end effector including at least two forceps cups; a first tube including a first connecting portion and a first tube segment; a second tube including a second connecting portion and a second tube segment, the second tube segment being connected to the first tube segment, the second connecting portion being used to connect the end effector; a control member passing through the first tube and the second tube, the distal end of the control member being connected to the end effector, the control member including two control wires intersecting at a first position; and a limiting structure located proximal to the first position and between the two control wires, for abutting against the two control wires.

[0012] Details of one or more embodiments of this application are set forth in the following drawings and description. Other features, objects, and advantages of this application will become apparent from the specification, drawings, and claims. Attached Figure Description

[0013] To better describe and illustrate embodiments and / or examples of the inventions disclosed herein, reference may be made to one or more accompanying drawings. Additional details or examples used to describe the drawings should not be considered as limiting the scope of any of the disclosed inventions, the currently described embodiments and / or examples, or the best mode of these inventions as currently understood.

[0014] Figure 1 is a schematic diagram of a biopsy device according to one or more embodiments;

[0015] Figure 2 is a schematic diagram of a biopsy device according to one or more embodiments;

[0016] Figure 3 is a schematic diagram of a biopsy device according to one or more embodiments;

[0017] Figure 4 is a schematic diagram of a biopsy device according to one or more embodiments;

[0018] Figure 5 is a structural schematic diagram of a biopsy device in one or more embodiments in a usage posture;

[0019] Figure 6 is a partial structural schematic diagram of the angle adjustment mechanism according to one or more embodiments;

[0020] Figure 7 is a structural schematic diagram of the first tube according to one or more embodiments;

[0021] Figure 8 is a schematic diagram of the structure of the second tube according to one or more embodiments;

[0022] Figure 9 is a structural schematic diagram of a cup holder according to one or more embodiments;

[0023] Figure 10 is a schematic exploded view of a cup holder according to one or more embodiments;

[0024] Figure 11 is a schematic diagram of the structure of a cup holder according to one or more embodiments;

[0025] Figure 12 is a schematic process structure diagram of the cup holder according to one or more embodiments before manufacturing is completed;

[0026] Figure 13 is a structural schematic diagram of a cup holder according to one or more embodiments;

[0027] Figure 14 is a schematic diagram of the cup holder according to one or more embodiments;

[0028] Figure 15 is a schematic exploded view of a cup holder according to one or more embodiments;

[0029] Figure 16 is a schematic diagram of the structure of the control component according to one or more embodiments;

[0030] Figure 17 is a schematic diagram of the handle mechanism according to one or more embodiments;

[0031] Figure 18 is a schematic enlarged view of point A in Figure 17;

[0032] Figure 19 is a schematic flowchart of a method for operating the aforementioned angle adjustment mechanism according to one or more embodiments;

[0033] Figure 20 is a schematic diagram of the handle mechanism according to one or more embodiments;

[0034] Figure 21 is a schematic diagram of the control component and lubrication pipe according to one or more embodiments;

[0035] Figure 22 is a schematic diagram of the structure of a gasket according to one or more embodiments;

[0036] Figure 23 is a schematic diagram of the forceps head assembly in a biopsy forceps according to one or more embodiments, viewed from one perspective.

[0037] Figure 24 is a partial cross-sectional view of the forceps head assembly in a biopsy forceps according to one or more embodiments;

[0038] Figure 25 is a theoretical schematic diagram of the magnitude of the clamping force of the forceps cup in a biopsy forceps according to one or more embodiments;

[0039] Figure 26 is a schematic diagram of the formula for the magnitude of the clamping force of the forceps cup in a biopsy forceps according to one or more embodiments;

[0040] Figure 27 is a schematic diagram of the stop protrusion of the biopsy forceps according to one or more embodiments;

[0041] Figure 28 is a schematic diagram of the notch in a biopsy forceps according to one or more embodiments;

[0042] Figure 29 is a schematic diagram of a first embodiment of the control according to one or more embodiments;

[0043] Figure 30 is a schematic diagram of a second embodiment of the control according to one or more embodiments;

[0044] Figure 31 is a schematic diagram of a third embodiment of the control according to one or more embodiments;

[0045] Figure 32 is a schematic diagram of a fourth embodiment of the control according to one or more embodiments;

[0046] Figure 33 is a schematic diagram of a fifth embodiment of the control according to one or more embodiments;

[0047] Figure 34 is a schematic diagram of a sixth embodiment of the control according to one or more embodiments;

[0048] Figure 35 is a schematic diagram of a seventh embodiment of the control according to one or more embodiments;

[0049] Figure 36 is a schematic diagram of an eighth embodiment of the control according to one or more embodiments;

[0050] Figure 37 is a schematic diagram of a ninth embodiment of the control according to one or more embodiments;

[0051] Figure 38 is a schematic diagram of a tenth embodiment of the control according to one or more embodiments;

[0052] Figure 39 is a schematic diagram of an eleventh embodiment of the control according to one or more embodiments;

[0053] Figure 40 is a schematic diagram of a twelfth embodiment of the control according to one or more embodiments;

[0054] Figure 41 is a schematic diagram of a thirteenth embodiment of the control according to one or more embodiments;

[0055] Figure 42 is a schematic diagram of a fourteenth embodiment of the control according to one or more embodiments;

[0056] Figure 43 is a schematic diagram of a fifteenth embodiment of a control according to one or more embodiments;

[0057] Figure 44 is a schematic diagram of a sixteenth embodiment of the control according to one or more embodiments;

[0058] Figure 45 is a schematic diagram of a seventeenth embodiment of the control according to one or more embodiments;

[0059] Figure 46 is a schematic diagram of an eighteenth embodiment of the control according to one or more embodiments.

[0060] Reference numerals: 100, Biopsy device; 110, Sheath assembly; 210, Angle adjustment mechanism; 10, Cup seat; 1, First tube; 11, First tube segment; 111, Inner limiting ring; 1110, Limiting through hole; 112, Extension tube segment; 12, First connecting part; 13, Stop protrusion; 2, Second tube; 201, Gap; 202, Dovetail groove structure; 21, Second tube segment; 211, Receiving tube segment; 2111, Internal tube; 2112, External tube; 2113, Second annular protrusion; 2114, First annular protrusion; 212, Buckling part; 2120, Locking tooth; 2121, First locking tooth; 2122, Second locking tooth; 2123, Gap tube segment; 2124, Buffer tube segment; 2125. 2125A, Ring edge front body; 2126, Transition tube section; 2127, Rotating sleeve; 22, Second connecting part; 23, Gasket; 2301, Notch; 3, Control component; 31, Control wire; 301, First bending section; 302, Second bending section; 303, Third bending section; 304, First bending part; 305, Second bending part; 306, Third bending part; 307, Fourth bending part; 308, Hook; 309, Bending stroke section; 3101, First position; 3102, Second position; 311, First control wire; 312, Second control wire; 32, Torque wire; 33, Fixed tube; 4, Flexible tube; 41, Lubrication tube; 42, Fixing component; 401, Channel; 120. Pliers head assembly; 220. End fitting; 5. Pliers cup; 51. Pliers head; 52. Pliers handle; 521. Tail hole; 501. Pin; 502. First pliers cup; 503. Second pliers cup; 53. Limiting structure; 230. Handle mechanism; 231. First handle; 2310. Ring groove; 232. Second handle; 233. Guide tube; 234. Finger ring. Detailed Implementation

[0061] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0062] In the description of this application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., indicating the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0063] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0064] Furthermore, the terms "first," "second," and "third," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. For example, a first control wire may also be referred to as a second control wire, and a second control wire may also be referred to as a first control wire. In the description of this application, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0065] In this application, unless otherwise expressly specified and limited, the terms "connected," "linked," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; a flexible connection or a rigid connection along at least one direction; a mechanical connection or an electrical connection; a direct connection or an indirect connection through an intermediate medium, or a direct connection with an intermediate medium present; and they can also refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. The terms "installed," "set," "fixed," etc., can be broadly understood as connection. For those skilled in the art, the specific meaning of the above terms in this application can be understood according to the specific circumstances.

[0066] It should be noted that, in this application, the terms "distal end" and "proximal end" are used with the operator as the reference point. The end closer to the operator is the proximal end or proximal portion, and the end farther from the operator is the distal end or distal portion. The side closer to the operator is the proximal side or proximal side, and the side farther from the operator is the distal side or distal side. The distal direction and proximal direction represent two directions; the proximal-distal direction is parallel to the distal direction and proximal direction, and the proximal-distal direction does not specifically refer to the forward or reverse direction. The axial direction is the direction of pipe extension; the radial direction is the direction perpendicular to the direction of pipe extension; the circumferential direction refers to the "circumferential direction," that is, around the axis of the cylinder, and the circumferential direction is perpendicular to both the axial and radial directions.

[0067] It should be noted that the end-effector can be any instrument such as biopsy forceps, grasping forceps, electrocoagulation forceps, clamps, etc.

[0068] This embodiment provides a biopsy device for sampling within cavities and chambers via an endoscope passing through a cavity. Referring to FIG1, in an exemplary embodiment, the biopsy device 100 includes a handle mechanism 230, an angle adjustment mechanism 210, and an end effector 220. The angle adjustment mechanism 210 is used to install and control the end effector 220, and can adjust the posture of the end effector 220 in space to adapt to the sampling needs of lesions at different angles. For ease of description, the end of the biopsy device 100 where the handle mechanism 230 is located in FIG1 is considered the proximal end, and the end where the end effector 220 is located is considered the distal end. A spatial rectangular coordinate system XYZ can also be established, but the shape and posture of the product provided in this application are not limited thereto.

[0069] For example, referring to Figures 2 to 4, the angle adjustment mechanism 210 provided in this application includes a first tube 1, a second tube 2, a control member 3, and a flexible tube 4. From the distal end to the proximal end of the angle adjustment mechanism 210, the first tube 1, the second tube 2, and the flexible tube 4 are connected in sequence. The control member 3 passes through the first tube 1, the second tube 2, and the flexible tube 4. The force on the proximal end of the control member 3 can be transmitted to the distal end of the control member 3 and then to the end device 220.

[0070] For example, the first tube 1 and the second tube 2 of the angle adjustment mechanism 210 constitute a rotating mechanism. The first tube 1 includes a first connecting part 12 and a first tube segment 11, and the second tube 2 includes a second connecting part 22 and a second tube segment 21. The second tube segment 21 is rotatably connected to the first tube segment 11, so that the first tube 1 and the second tube 2 are rotatably connected. Both the first tube 1 and the second tube 2 can be rigid tubes or round tubes. In Figure 1, the axial direction of the second tube segment 21 in the second tube 2 is substantially parallel to the X-axis direction, and the rotation axis Q1 of the second tube segment 21 is substantially parallel to its axial direction. The rotation axis Q1 can be the central axis of the second tube segment 21, or it can be eccentric. For example, the second tube segment 21 and the first tube segment 11 can be coaxially arranged, but they can also be eccentrically arranged. The second tube segment 21 is axially engaged with the first tube segment 11, which is simple and direct to install, and the first tube 1 and the second tube 2 are not easily separated.

[0071] The distal end of the flexible tube 4 is connected to the first connecting portion 12 of the first tube 1. The flexible tube 4 may include a spring hose, which is fixed to the first connecting portion 12, for example, by welding or gluing. The flexible tube 4 may include a sealing protective layer as the outermost layer. The flexible tube 4 is flexible and can follow the bending of the endoscope to ensure that the end instrument 220 or the like can be smoothly inserted into the cavity and reach the position where the end instrument 220 needs to perform its work during use.

[0072] The control element 3 can pass through the first pipe section 11 and the second pipe section 21 and is adapted to slide substantially axially. The distal end of the control element 3 is movable relative to the second connecting portion 22. The second connecting portion 22 is used to connect to the end device 220. The proximal end of the control element 3 extends a flexible tube 4 to connect to the handle mechanism 230, and the distal end extends a flexible tube 4 to connect to the end device 220. Exemplarily, the distal end of the control element 3 can be a wire hook, such as hook 308. The position of hook 308 in space is offset from the rotation axis Q1 of the second connecting portion 22. When calculating the effective length of the control element 3, the portion of hook 308 extending beyond the connection point between hook 308 and end device 220 can be disregarded.

[0073] The handle mechanism 230 can drive the proximal end of the control member 3 to rotate, so that the distal end of the control member 3 is subjected to torque about the rotation axis Q1, which in turn drives the end device 220 and the second tube 2 to rotate together. The second tube 2 can rotate to the desired rotation angle position relative to the first tube 1. Understandably, the parts positioned relative to the second tube 2 in the circumferential direction also rotate accordingly.

[0074] The flexible tube 4 and control element 3 of the angle adjustment mechanism 210 can also constitute a deflection mechanism. The end effector 220 can be defined with an orientation, such as the jaw opening direction or the jaw closing direction. By applying an external force to the distal end of the end effector 220, the end effector 220 drives the control element 3 connected to it to move relative to the flexible tube 4, which can offset the original orientation of the end effector 220 from the position of the rotation axis Q1. For example, as shown in Figure 5, when the end effector 220 is in the open state, its distal end abuts against the object to be clamped (lesion). The reaction force F applied by the object to be clamped can drive the end effector 220 to rotate to the desired lateral angle position to better correspond to the object to be clamped. The bending control element 3 can absorb the change in fitting dimensions caused by the lateral rotation of the end effector 220. For example, when the end effector 220 is rotated by the reaction force F, the control element 3 can move and bend within the flexible tube 4 to adapt to the rotation of the end effector 220.

[0075] The angle adjustment mechanism 210 operates stably and flexibly, enabling a wide range of rotation and / or lateral rotation angles. The end effector 220 includes a biopsy forceps cup, a grasping forceps cup, an electrocoagulation forceps cup, or a clamp.

[0076] Referring to Figures 2 to 5, exemplarily, the end effector 220 includes at least two clamp cups 5, and the control element 3 includes at least two control wires 31, the distal ends of which are connected to and used to control the corresponding clamp cup 5. The clamp cups 5 of the biopsy device 100 may be biopsy clamp cups. The inner diameter of the channel 401 within the flexible tube 4 for through which the control element 3 passes is larger than the outer diameter of the control element 3. Specifically, the inner diameter of the channel 401 is larger than the sum of the diameters of all the control wires 31. The control wires 31 are slidable within the channel 401. Exemplarily, a lubrication tube 41 is provided within the flexible tube 4, and the lubrication tube 41 may be disposed within a spring hose. The control element 3 passes through the lubrication tube 41, and has low friction when sliding, which is beneficial for sensitive control of the end effector 220 and also for protecting the control element 3 and the spring hose. The lubrication tube 41 may be used to define and form the channel 401.

[0077] Referring to Figure 2, both clamp cups 5 (first clamp cup 502 and second clamp cup 503) are rotatably connected to the second connecting part 22 via a pin 501, the axis of which intersects the rotation axis Q1. Exemplarily, the axis of the pin 501 is approximately parallel to the Z-axis direction and then perpendicular to the rotation axis Q1. Each clamp cup 5 includes a clamp head 51 and a clamp handle 52, located on either side of the pin 501. A control wire 31 is connected to the clamp handle 52; when the control wire 31 is pushed or pulled, the clamp cups 5 rotate around the pin 501, allowing both clamp cups 5 to be in an open or closed state. Referring to Figure 2, in the two clamp cups 5, the first clamp cup 502 rotates clockwise for closing, while the second clamp cup 503 rotates counterclockwise for closing. In the open state, the two clamp heads 51 are sufficiently far apart; in the closed state, the two clamp heads 51 are close together, for example, allowing the cutting edge to cut the tissue to be sampled. The cutting edges of the two pliers 51 can be located in a plane. Therefore, when the cutting edge plane cuts tissue at different angles, it may have different effects. Thus, the appropriate cutting angle can be selected as needed to achieve better results.

[0078] When using the biopsy device 100, the tissue to be sampled may be located directly in front of the distal end of the end device 220. In this case, it is not necessary to rotate the second tube 2 and the end device 220, nor is it necessary to turn the end device 220 to the side. The control element 3 can be pulled directly, and then the two clamp cups 5 of the end device 220 will obtain the sample tissue. When the end device 220 is not directly facing the tissue to be sampled, the end device 220 can be rotated or / and turned to the side to adjust its gripping angle so that it is aligned with the tissue to be sampled, achieving accurate sampling. The biopsy device 100 can adapt to a variety of operational needs.

[0079] Specifically, the first pipe 1 (especially the first pipe segment 11) and the second pipe 2 (especially the second pipe segment 21) are rotatably connected. The second pipe segment 21 includes a receiving pipe segment 211 and a snap-fit ​​part 212 arranged sequentially from the distal end to the proximal end. The first pipe segment 11 includes an inner limiting ring 111. A limiting through hole 1110 for the snap-fit ​​part 212 to pass through is formed in the middle of the inner limiting ring 111. The inner limiting ring 111 is restricted between the receiving pipe segment 211 and the snap-fit ​​part 212 in the direction of the distal end. The receiving pipe segment 211 is rotatably connected to the inner limiting ring 111 through the snap-fit ​​part 212.

[0080] Referring to Figure 6, in the exemplary first rotary connection embodiment, the receiving tube segment 211 and the snap-fit ​​part 212 are integrally formed. The snap-fit ​​part 212 includes a gap tube segment 2123 connected to the receiving tube segment 211 and at least two snap teeth 2120 circumferentially spaced along the proximal end of the gap tube segment 2123. That is, the second tube segment 21 includes the receiving tube segment 211, the gap tube segment 2123, and the snap teeth 2120 arranged sequentially from far to near. The snap teeth 2120 pass through the first tube segment 11. During installation, the snap teeth 2120 can pass through the inner limiting ring 111 and enter the first tube segment 11. The inner limiting ring 111 is axially restricted between the receiving tube segment 211 and the snap teeth 2120. The second tube segment 21 may include more than two snap teeth 2120. The surface of the retaining tooth 2120 used to limit the inner limiting ring 111 can be approximately flat; the guide surface of the retaining tooth 2120 facing the inner limiting ring 111 during installation can be inclined. When the first pipe 1 and the second pipe 2 rotate relative to each other, the inner limiting ring 111 rotates approximately around the gap pipe section 2123.

[0081] Referring to Figures 1, 2, and 5, the first connecting portion 12 is used to connect the flexible tube 4, and the second connecting portion 22 may have a pin hole for the pin shaft 501 to pass through. In some embodiments, the second connecting portion 22 of the second tube 2 is used to connect the flexible tube 4, and the first connecting portion 12 of the first tube 1 is used to connect other mechanisms in conjunction with the control component 3. In some embodiments, the engaging structures of the first tube 1 and the second tube 2 can be interchanged, with the snap-fit ​​portion 212 disposed at the first tube segment 11 and the inner limiting ring 111 disposed at the second tube segment 21, and the rotational connection between the first tube segment 11 and the second tube segment 21 is achieved by inserting the proximal end of the first tube segment 11 into the second tube segment 21. In this embodiment, the snap-fit ​​portion 212 is configured on the second tube 2, which allows the radial dimension of the second tube 2 to be smaller. Both the first tube 1 and the second tube 2 can be sheet metal parts, which can be manufactured separately and then simply assembled. Exemplarily, the thickness of the first tube 1 and the second tube 2 can be approximately equal at various positions.

[0082] For example, the gap section 2123 has a plurality of slits 201 extending toward the receiving section 211. The plurality of slits 201 circumferentially separate a plurality of retaining teeth 2120. When the second section 21 is installed into the first section 11, the retaining teeth 2120 are compressed together, and after installation, the retaining teeth 2120 will rebound. The slits 201 facilitate the compression and rebound of the retaining teeth 2120.

[0083] For example, the slit 201 extends through to the proximal end face of the second tube 2, dividing the proximal end of the second tube 2 into a multi-lobed structure. Referring to Figure 8, the slit 201 extends into the receiving tube segment 211, which helps to give the multi-lobed structure corresponding to the retaining teeth 2120 in the second tube segment 21 better elasticity. For example, the axial distance N of the slit 201 extending into the receiving tube segment 211 is less than or equal to 0.3 mm, for example, 0.1 mm or 0.2 mm, which can ensure the structural strength of the receiving tube segment 211. The second tube 2 can be formed from a metal sheet through processes such as stamping and rolling. When the metal sheet is rolled into a tube, a dovetail groove structure 202 can be provided at the joint edge. The extension depth of the slit 201 can be designed such that it does not reach the depth of the dovetail groove structure 202 along the axial direction.

[0084] The outer diameter of the receiving tube section 211 is larger than the outer diameter of the gap tube section 2123, and the inner diameter of the receiving tube section 211 can also be larger than the inner diameter of the gap tube section 2123. The second tube section 21 also includes a transition tube section 2126, through which the gap tube section 2123 is connected to the receiving tube section 211. The connections between the various tube sections of the second tube 2 can be rounded, making the second tube 2 easy to manufacture and possessing sufficient strength and elasticity. The inner wall surface of the transition tube section 2126 is conical, which helps reduce friction on the control wire 31. The outer wall surface of the transition tube section 2126 can also be conical, still able to axially restrict the inner limiting ring 111.

[0085] Referring to Figures 2 to 4, a gasket 23 is provided inside the second tube section 21. The gasket 23 is connected to the second connecting part 22 or the receiving tube section 211, for example, the gasket 23 is connected to the second connecting part 22 via a pin 501. The gasket 23 can prevent the clamp cup 5 from excessively rotating and returning to its original position. When the clamp cup 5 is pulled by the control wire 31, the clamp handle 52 can be pulled to a position close to and / or away from the rotation axis Q1. When the protrusion on the clamp handle 52 abuts against the gasket 23, it can prevent the clamp handle 52 from continuing to rotate. The portion of the gasket 23 inside the receiving tube section 211 has a radially extending sheet-like structure, which can separate different control wires 31. The protrusion can be a component formed at the connection between the control member 3 and the clamp handle 52.

[0086] The second pipe section 21 may further include a buffer pipe section 2124, which is located on the side of the retaining teeth 2120 away from the receiving pipe section 211. When assembling the first pipe 1 and the second pipe 2, the buffer pipe section 2124 first passes through the inner limiting ring 111, which helps guide the retaining teeth 2120 to smoothly pass through and engage with the inner limiting ring 111. For example, the axial dimension of the buffer pipe section 2124 is greater than or equal to 0.1 mm, which helps to ensure the guiding effect during installation. After installation, the buffer pipe section 2124 is spaced from the first connecting portion 12.

[0087] For example, the axial dimension of the gap section 2123 ranges from 0.15 mm to 2 mm, such as 0.5 mm, 1 mm, or 1.5 mm. This provides sufficient space to limit the inner retaining ring 111 and ensures reliable engagement of the retaining teeth 2120. The difference δ1 between the outer diameter of the gap section 2123 and the inner diameter of the inner retaining ring 111 can satisfy: 0 mm < δ1 ≤ 0.15 mm.

[0088] The second pipe segment 21 may include multiple locking teeth 2120. Exemplarily, the second pipe segment 21 includes a first locking tooth 2121 and a second locking tooth 2122 that are radially opposite each other. Referring to Figures 6 and 7, the outer diameter D3 of the buffer pipe segment 2124 is smaller than the inner diameter D1 of the inner limiting ring 111, and the maximum outer diameter D4 of the first locking tooth 2121 and the second locking tooth 2122 is larger than the inner diameter D1 of the inner limiting ring 111 to achieve locking. The maximum outer diameter D4 is smaller than the inner diameter of the extension pipe segment 112, and the difference δ2 between the two can satisfy: 0mm < δ2 ≤ 0.22mm. Exemplarily, the inner limiting ring 111 and the extension pipe segment 112 can be connected by an arc, and the maximum outer diameter D4 can be smaller than the outer diameter D2 of the inner limiting ring 111 to ensure stable locking.

[0089] The arc between two slits 201 adjacent to the clasp 2120 along the circumference can be less than π. The gap tube segment 2123 is divided into several segments along the circumference by the slits 201. The length of the segment connected by a clasp 2120 is less than a semicircular arc. This segment can be longer than the clasp 2120 along the circumference to ensure elasticity and facilitate the avoidance action of the clasp 2120. Optionally, the four slits 201 are evenly arranged along the circumference. The width of each slit 201 is less than the width of the clasp 2120. The entire second tube 2 is integrally formed, that is, the second connecting part 22, the accommodating tube segment 211, the transition tube segment 2126, the gap tube segment 2123, the clasp 2120, and the buffer tube segment 2124 are integrally formed; or / and the entire first tube 1 is integrally formed, that is, the inner limiting ring 111, the extension tube segment 112, and the first connecting part 12 are integrally formed.

[0090] Referring to Figures 9 and 10, in the exemplary second rotary connection embodiment, the receiving tube segment 211 and the latching part 212 are separately disposed. That is, the latching part 212 includes an integrally disposed transition tube segment 2126, a gap tube segment 2123, and at least two circumferentially spaced latching teeth 2120 along the proximal end of the gap tube segment 2123. The transition tube segment 2126 is built into the proximal end of the receiving tube segment 211, and the transition tube segment 2126 is tapered. The proximal ends of the latching teeth 2120 are hooked onto the inner limiting ring 111.

[0091] The snap-fit ​​portion 212 may also include a rotating sleeve 2127, which is built into the receiving tube section 211. The proximal end of the rotating sleeve 2127 is connected to the transition tube section 2126, which may be divided into multiple elastic arms or be considered to be divided by at least two gaps 201. Referring to Figure 16, the second connecting portion 22 and the receiving tube section 211 may be sheet metal coils, which can be fixed to the rotating sleeve 2127 by welding.

[0092] The two locking teeth 2120 of the latching part 212 can be specifically designated as a first locking tooth 2121 and a second locking tooth 2122. The curvature of each locking tooth 2120 can be approximately π / 4. The gap 201 between the first locking tooth 2121 and the second locking tooth 2122 is distributed in the same direction as the opening and closing direction of the end device 220, which facilitates sufficient movement space for the control wire 31 to drive the end device 220 during opening and closing, ensuring the flexibility of the end device 220 during opening, closing, lateral rotation, and rotation.

[0093] In this embodiment, during installation, the rotating sleeve 2127 of the snap-fit ​​part 212 is first fixed to the receiving pipe section 211 by welding. During welding, it is necessary to ensure that the snap teeth 2120 are exposed outside the receiving pipe section 211. Then, the snap-fit ​​part 212 with the receiving pipe section 211 is inserted into the limiting through hole 1110 to connect the first pipe section 11 and the second pipe section 21. Compared with the first integrated embodiment, this embodiment is more stable during connection, and the separate arrangement of the receiving pipe section 211 and the snap-fit ​​part 212 makes it easier to process and manufacture, reducing production costs.

[0094] Referring to Figure 11, in the exemplary third rotating connection embodiment, the snap-fit ​​part 212 and the receiving tube section 211 are separately provided. The snap-fit ​​part 212 includes an integrally formed transition tube section 2126, a gap tube section 2123, and an annular edge 2125. The transition tube section 2126 is welded inside the receiving tube section 211, and the gap tube section 2123 is connected to the receiving tube section 211 through the transition tube section 2126. The gap tube section 2123 and the annular edge 2125 are exposed outside the receiving tube section 211, and the annular edge 2125 is folded outward relative to the gap tube section 2123. A limiting through hole 1110 for the gap tube section 2123 to pass through is formed in the middle of the inner limiting ring 111. The outer diameter D4 of the annular edge 2125 is larger than the diameter D1 of the limiting through hole 1110, so that the annular edge 2125 will not be pulled out from the inner limiting ring 111 in the distal direction, and the annular edge 2125 can be continuous and intact in the circumferential direction. The outer diameter D6 of the receiving tube section 211 is greater than the outer diameter D3 of the gap tube section 2123. Exemplarily, the first tube 1 and the second tube 2 can be configured to be substantially coaxial and of equal diameter.

[0095] The snap-fit ​​part 212 may also include a rotating sleeve 2127 connected to the transition tube section 2126, which helps the snap-fit ​​part 212 to be stably installed in the receiving tube section 211. The outer circumference of the cup seat 10 is smooth and continuous, and the transition tube section 2126 can extend radially to form an annular groove between itself and the ring edge 2125 for the inner limiting ring 111 to engage. The annular groove and the inner limiting ring 111 are fitted with a clearance. This clearance should not be too large or too small. If the clearance is too large, it will easily cause rotational wobbling between the first tube 1 and the second tube 2. If the clearance is too small, it will easily cause rotational jamming between the first tube 1 and the second tube 2.

[0096] The installation method of this embodiment is as follows: Referring to Figure 12, the initial state of the snap-fit ​​part 212 may include a transition pipe section 2126, a gap pipe section 2123, and a ring edge front body 2125A extending axially along the gap pipe section 2123. During installation, the ring edge front body 2125A is first inserted into the first pipe section 11 through the self-limiting through hole 1110. Then, the ring edge front body 2125A is folded over by a stamping device to obtain the ring edge 2125 as shown in Figure 11, thereby realizing the installation between the snap-fit ​​part 212 and the first pipe section 11. The snap-fit ​​part 212 is easy to manufacture, has good structural strength, and rotates flexibly.

[0097] Referring to Figure 13, in the exemplary fourth rotary connection embodiment, based on the third rotary connection embodiment described above, in this embodiment, the transition tube segment 2126 and the gap tube segment 2123 form a cylindrical shape that is integrally formed, and the annular edge 2125 is an outwardly flange formed near the end of the gap tube segment 2123. The accommodating tube segment 211 includes an inner tube 2111 and an outer tube 2112, with the inner tube 2111 embedded between the outer tube 2112 and the transition tube segment 2126. An annular groove for the inner limiting ring 111 to be inserted is formed between the inner tube 2111 and the annular edge 2125. The structural components of the cup holder 10 are easy to manufacture, have high strength, and the cup holder 10 has a stable structure.

[0098] The installation method of this embodiment is as follows: First, fix the inner tube 2111 to the inner side of the proximal end of the outer tube 2112, and insert the buckle part 212 into the proximal end of the first tube section 11. Then, extend the transition tube section 2126 out from the limiting through hole 1110, so that the ring edge 2125 is fastened to the inner side of the inner limiting ring 111. Then, extend the transition tube section 2126 into the inner tube 2111 and weld the two together to fix them, thereby completing the installation of the first tube section 11 and the second tube section 21.

[0099] Referring to Figures 14 and 15, based on the fourth rotary connection embodiment described above, exemplarily, in order to assemble a precisely constructed cup holder 10, a first annular protrusion 2114 may be formed at the distal end of the built-in tube 2111, abutting against the distal surface of the transition tube section 2126. Specifically, the inner diameter of the first annular protrusion 2114 is larger than the inner diameter of the transition tube section 2126 and smaller than the outer diameter of the transition tube section 2126. On the one hand, the first annular protrusion 2114 can provide positioning for the transition tube section 2126 during installation; on the other hand, setting the inner diameter of the first annular protrusion 2114 to be larger than the inner diameter of the transition tube section 2126 allows the control member 3 to have suitable outward expansion space during the pushing process, avoiding restriction due to the small inner diameter of the transition tube section 2126.

[0100] Furthermore, the proximal end of the inner tube 2111 can also form a second annular protrusion 2113 that abuts against the proximal end face of the outer tube 2112. An annular groove for the inner limiting ring 111 to be inserted is formed between the proximal end face of the second annular protrusion 2113 and the distal end face of the ring edge 2125. Specifically, the outer diameter of the second annular protrusion 2113 is larger than the diameter of the limiting through hole, and the outer diameter of the second annular protrusion 2113 is smaller than the outer diameter of the outer tube 2112, ensuring that the inner tube 2111 is installed at the proximal end of the outer tube 2112 along the proximal-distal direction, which facilitates assembly and positioning, making the cup holder 10 easy to assemble and the mechanism stable in operation.

[0101] Based on the four embodiments described above, and referring to Figure 6, the first tube 1 may further include a stop protrusion 13, which is located between the first connecting portion 12 and the first tube segment 11. The stop protrusion 13 protrudes radially inward along the first tube 1. For example, if the flexible tube 4 is inserted into the first connecting portion 12, the stop protrusion 13 protrudes inward relative to the first connecting portion 12 to limit the insertion depth of the flexible tube 4 axially. The stop protrusion 13 and the second tube segment 21 are spaced apart axially to ensure that after the second tube segment 21 is assembled with the first tube segment 11, the second tube segment 21 will not collide or interfere with the distal end of the flexible tube 4.

[0102] For example, the first pipe section 11 also includes an extension pipe section 112, which is located between the inner limiting ring 111 and the stop protrusion 13, ensuring that there is a gap between the inner limiting ring 111 and the stop protrusion 13, leaving enough space for the installation of the snap-fit ​​part 212.

[0103] Referring to FIG1, the biopsy device 100 of this embodiment can manipulate the angle adjustment mechanism 210 and the end effector 220 using the handle mechanism 230. Exemplarily, as shown in FIGS. 17 and 18, the handle mechanism 230 includes a first handle 231 and a second handle 232. The first handle 231 is rotatably connected to the proximal end of the flexible tube 4, for example, to a fixing member 42 disposed at the proximal end of the flexible tube 4. The fixing member 42 can be fixed to the proximal end of the spring flexible tube. The fixing member 42 can be a metal part or other part with a certain strength, capable of being axially limited to the first handle 231 and rotating relative to it about an axis. Exemplarily, at least a portion of the outer diameter of the fixing member 42 is larger than the outer diameter of the spring flexible tube; this portion can have a disc shape, and the first handle 231 can then be provided with an annular groove 2310 that mates with this portion. In other embodiments, the fixing member can be provided with an annular groove, and the first handle has a protrusion axially limited to and rotatable along the annular groove.

[0104] The second handle 232 is slidably connected to the first handle 231. The sliding direction of the second handle 232 can be the distal-proximal direction or other directions that can drive the control member 3 to move. Referring to Figure 17, when the second handle 232 is pushed distally or pulled proximally relative to the first handle 231, the proximal end of the control member 3 moves along the distal-proximal direction along with the second handle 232, thereby controlling the opening and closing action of the end device 220.

[0105] Referring to Figure 18, the handle mechanism 230 also includes a guide tube 233, which is fixed to the proximal end of the control member 3 for securing the proximal end of the control member 3 to the second handle 232. The proximal end of the guide tube 233 is bent and fixed to the second handle 232, and can then slide along the first handle 231 under the action of the second handle 232. Optionally, the second handle 232 may include two interlocking halves. The assembly method of the second handle 232 facilitates installation onto the first handle 231 and also facilitates connection of the guide tube 233.

[0106] The handle mechanism 230 may also include a ring 234, which is rotatably connected to the first handle 231 and may be coaxial with the proximal end of the flexible tube 4. When it is necessary to rotate the first handle 231 or move the second handle 232, the ring 234 can be held to stably operate the first handle 231 or the second handle 232.

[0107] In other embodiments, other mechanisms may be used to replace the handle mechanism 230 to achieve the same function, such as the automated mechanism manipulating the angle adjustment mechanism 210 and the end effector 220.

[0108] Referring to FIG19, this application provides a method 1000 for operating an angle adjustment mechanism, which can be performed based on an angle adjustment mechanism 210 provided with an end effector 220. Further, this application provides a method for operating a biopsy device, which can be performed based on the aforementioned biopsy device 100. The method for operating the biopsy device may include the steps of the method 1000 for operating the angle adjustment mechanism. The method for operating the biopsy device may also involve checking the sensitivity of the operation of the biopsy device 100. Exemplarily, the biopsy device 100 can be used to sample tissue. During the sampling process, the steps of the method 1000 for operating the angle adjustment mechanism can be performed. The method 1000 may include at least one of the following steps, and different steps can be performed according to usage requirements, adapting to diverse operational needs.

[0109] When the angular position of the end device 220 is not suitable, the end device 220 can be rotated to adjust its angular position. Step S101 includes: rotating the control member 3 by rotating the first handle 231, thereby causing the end device 220 and the second tube 2 to rotate relative to the first tube 1. Specifically, the flexible tube 4 can be kept stationary, and thus the first tube 1 can also be kept stationary. Rotating the first handle 231 causes the second handle 232, the guide tube 233, and the control member 3 to rotate, and then the torque is transmitted along the control member 3 to the end device 220 and the second tube 2 at the distal end of the control member 3. The end device 220 and the second tube 2 can rotate relative to the first tube 1 around the rotation axis Q1 to the desired angular position.

[0110] For example, the end effector 220 can be in a clamped state before rotation, and after rotation, the end effector 220 can be controlled to become an open state (e.g., push the second handle 232 distally), depending on the surgical scenario.

[0111] When the lateral position of the end device 220 is not suitable, the end device 220 can be laterally rotated to a suitable position. Step S102: The end device 220 is laterally rotated relative to the second tube 2.

[0112] Referring to Figure 5, the end effector 220 includes a first clamp cup 502 and a second clamp cup 503. A pin 501 may be perpendicular to the XY plane, and the plane in which the first clamp cup 502 and the second clamp cup 503 rotate about the pin 501 may be parallel to the XY plane. The proximal end of the flexible tube 4 may have an axis Q2, which may be parallel to the X-axis direction. To allow the end effector 220 to rotate laterally, an external force F may be applied to, for example, the distal end of the first clamp cup 502. During sampling, the first clamp cup 502 may be pressed against the tissue to be sampled, and then the flexible tube 4 may be pushed. An external force F deviates from the rotation axis Q1 and forms a torque, causing the end device 220 to rotate relative to the second tube 2. For example, the rotation is in the posture shown in Figure 5, that is, the first clamp cup 502 and the second clamp cup 503 rotate in the same direction around the pin shaft 501, and the opening between the first clamp cup 502 and the second clamp cup 503 can rotate to a direction that deviates from the rotation axis Q1. The rotation axis Q1 can be parallel to the Y-axis direction and perpendicular to the axis Q2.

[0113] Specifically, during the side-turning process, the first clamp cup 502 rotates counterclockwise around the pin 501, and the jaw 51 of the first clamp cup 502 has a large included angle with the rotation axis Q1 in the XY plane. The jaw 51 of the first clamp cup 502 may have a contact point with the handle 52 of the second clamp cup 503, or / and the handle 52 of the first clamp cup 502 may have a contact point with the jaw 51 of the second clamp cup 503. When the first clamp cup 502 rotates to the point where it can contact the second clamp cup 503, the first clamp cup 502 will drive the second clamp cup 503 to rotate together. The second clamp cup 503 rotates around the pin 501, and the jaw 51 of the second clamp cup 503 has a small included angle with the rotation axis Q1 in the XY plane.

[0114] Referring to Figure 5, the flexible tube 4 has a channel 401. When the flexible tube 4 is bent, the side with a smaller bending radius is compressed, while the side with a larger bending radius is stretched. Therefore, in the channel 401 of the flexible tube 4, the travel distance on the side with a smaller bending radius is less than that on the side with a larger bending radius. For different control wires 31, there are different travel distances on the side with a smaller bending radius and the side with a larger bending radius in the channel 401, and there is a travel difference between the travel distances, which provides conditions for the lateral rotation of the end device 220. For example, the distance between the proximal end of the control wire 31 and the distal end of the flexible tube 4 is greater than 60 mm, which helps the channel 401 to provide a sufficient travel difference.

[0115] As shown in Figure 5, the multiple control wires 31 of the control element 3 include a first control wire 311 and a second control wire 312. During the lateral rotation, the handle 52 of the first clamp cup 502 moves further away from the first tube 1, and the first control wire 311 connected to it is pulled further away, bending as the flexible tube 4 bends. The first control wire 311 is pulled closer to the side with a smaller bending radius within the channel 401. Influenced by the first clamp cup 502, the handle 52 of the second clamp cup 503 moves closer to the first tube 1 during the lateral rotation, and the second control wire 312 connected to it is pushed closer, bending as the flexible tube 4 bends. The second control wire 312 is pulled closer to the side with a larger bending radius within the channel 401. There is a stroke difference between the second control wire 312 and the first control wire 311, which facilitates the lateral rotation of the end effector 220. The opening between the two clamp cups 5 of the end effector 220 is deflected relative to the rotation axis Q1.

[0116] This application also provides a method for operating an angle adjustment mechanism. This method may skip steps S101 and S102 and execute step S103; or execute step S103 after executing step S101, after executing step S102, or after executing steps S101 and S102. In step S103, the control element 3 controls the end effector 220 to perform a working action. The working action of the end effector 220 refers to the actions it performs to achieve its function, including but not limited to clamping, cutting, clamping, or opening.

[0117] The method of executing step S103 after executing steps S101 and S102 includes: step S101, driving the end device 220 and the second tube 2 to rotate relative to the first tube 1 by rotating the control member 3; step S102, causing the end device 220 to rotate sideways relative to the second tube 2; step S103, controlling the end device 220 to perform working actions by the control member 3.

[0118] To insert the biopsy device 100 into the cavity, the end instrument 220 can be kept in a clamped state. After the end instrument 220 enters the cavity or body, the two clamp cups 5 can be opened. For example, if the opening between the two clamp cups 5 is suitable for sampling, the control member 3 can be pulled to clamp the two clamp cups 5, and then the obtained tissue sample can be removed from the cavity using the biopsy device 100.

[0119] For example, after performing step S101, the second handle 232 is pulled proximally relative to the first handle 231, thereby clamping the two clamp cups 5 together so that the desired tissue sample can be cut off using the cutting edge.

[0120] For example, after performing step S102, as shown in FIG5, the second handle 232 is pulled towards the proximal end, and then the first control wire 311 and the second control wire 312 pull the first clamp cup 502 and the second clamp cup 503 respectively. The first clamp cup 502 rotates and tends to move toward the second clamp cup 503 until the two are closed. The second clamp cup 503 may not rotate or rotate less.

[0121] The biopsy device 100 provided in this application can achieve multiple angles and postures, allowing for flexible sampling. When the sampling angle is unsuitable, repeated withdrawal of the endoscope can be avoided, and the device can be easily adjusted within the cavity to achieve a suitable sampling posture. The biopsy device 100 has advantages such as high stability, accurate positioning, simple operation, and 360° rotation.

[0122] In an exemplary embodiment, the angle adjustment mechanism 210 provided in this application may include a first tube 1, a second tube 2, and a control member 3. The first tube 1 is connected to the second tube 2. The control member 3 passes through the first tube 1 and the second tube 2. The distal end of the control member 3 is connected to an end device 220. The control member 3 is used to drive the end device 220 and the second tube 2 to rotate relative to the first tube 1, and to drive the end device 220 to deviate relative to the rotation axis of the second tube 2. Through the control member 3, the end device 220 can be rotated and deviated, making operation convenient.

[0123] A flexible tube 4 is provided at the proximal end of the first connecting part 12. A lubrication tube 41 is provided inside the flexible tube 4, and at least a portion of the control member 3 passes through the channel 401 of the lubrication tube 41. Referring to Figure 3, the inner diameter of the channel 401 is larger than the outer diameter of the control member 3, and the inner diameter of the channel 401 is at least larger than the outer diameter of the portion it accommodates, so that the control member 3 can slide smoothly.

[0124] Referring to Figure 5, the control element 3 includes at least two control wires 31. Each control wire 31 includes a bending stroke segment 309 located within the flexible tube 4. Based on the parallel orientation of the at least two bending stroke segments 309, such as the Y-axis direction shown in Figure 5, a stroke difference can exist between the at least two control wires 31 when the flexible tube 4 is in a flexible bending state, causing the end device 220 to offset relative to the second tube 2. In other cases, when the flexible tube 4 is bent based on the XZ plane, there may be no stroke difference between the two control wires 31 parallel along the Y-axis direction, and they bend approximately at the same arc. When the bending surface of the flexible tube 4 deviates from the XZ plane, there will be a corresponding difference in the bending radii of the two control wires 31 parallel along the Y-axis direction.

[0125] Referring to Figure 20, the control element 3 includes two control wires 31, which are two torque wires. The proximal ends of the two torque wires can be fixed together and externally connected to the guide tube 233, thereby securing them to the second handle. The distal ends of the two torque wires are respectively connected to the two clamp cups 5 of the end effector 220. Optionally, there may be only two torque wires.

[0126] In some embodiments, the single torque wire is a uniformly shaped wire, and the ratio between the outer diameter of the torque wire and the inner diameter of the channel 401 is preferably in the range of 1:3.8 to 1:2.8. Optionally, the outer diameter of the torque wire can range from 0.23 mm to 0.38 mm, for example, 0.25 mm, 0.3 mm, or 0.35 mm, to ensure that the torque wire can balance torque transmission and bending resistance. The inner diameter of the channel 401 can range from 0.65 mm to 0.88 mm, for example, 0.7 mm, 0.8 mm, or 0.85 mm, to ensure that the two torque wires can move smoothly within the channel 401.

[0127] In other embodiments, the single torque wire can also be a wire with different characteristics at its proximal and distal ends. For example, the stiffness of the proximal end of the torque wire is greater than that of the distal end (especially the bending stroke section 309). Here, the proximal end is the length range extending distally from the connection point of the torque wire with the second handle to approximately 1 / 3 to 1 / 2 of the length of the entire wire, and the distal end is the length range extending proximally from the connection point of the torque wire with the clamp cup to approximately 1 / 2 to 2 / 3 of the length of the entire wire. This allows for the effective transmission of the torque provided by the handle mechanism 230 while also ensuring the bending resistance of the distal end of the control element 3. It should be noted that stiffness is the ability of a material or structure to resist elastic deformation under stress, which mainly depends on the elastic modulus (such as Young's modulus) and geometry of the material. The higher the elastic modulus, the less likely the control wire 31 is to deform under stress, and the greater the stiffness. In the embodiments of this application, since the control wire 31 needs to form a stroke difference in the bending section of the flexible tube 4, the control wire 31 has deformation requirements. Therefore, the stiffness of the distal end of the control wire 31, at least the bending stroke section 309, should not be too large. The proximal end of the control wire 31 is connected to the handle mechanism 230, which drives the control member 3 to rotate. It is necessary to ensure the normal transmission of rotational torque. Therefore, the stiffness of the proximal end of the control wire 31 should not be too small. Thus, the stiffness of the proximal end of the control wire 31 is greater than that of the distal end.

[0128] To measure the stiffness of torque wire, the nanoindentation method is commonly used. This method indirectly correlates the material's elastic modulus by measuring the load-displacement curve of nanoscale indentations on the surface of the torque wire, making it suitable for local performance evaluation. The core principle involves using a diamond indenter, such as a Berkovich triangular pyramid, to press the torque wire surface with a load of 10mN to 100mN. The contact stiffness is calculated based on the slope of the unloading curve, and then the elastic modulus E is derived using the Oliver-Pharr model. Finally, the overall stiffness k = EA / L is calculated by combining geometric parameters. Key steps include: surface treatment, specifically polishing local areas of the torque wire with 2000-grit sandpaper and ultrasonic cleaning to remove oil; indentation testing, specifically performing five indentations at different locations, each with a depth <500nm to avoid substrate effects, at a loading rate of 0.1mN / s; and data correlation, specifically substituting the measured elastic modulus into the formula to obtain the result.

[0129] For example, the material chosen for the torque wire is austenitic stainless steel, which possesses excellent plasticity and corrosion resistance; at the same time, its non-magnetic nature makes it an ideal material for medical devices. Taking the nano-indentation method calculation formula as an example, for a torque wire made of SUS304 stainless steel with an outer diameter range of 0.23mm to 0.38mm and a length of 2.3m, the theoretical range of the torque wire stiffness is 386N / m to 1736N / m, or 0.386N / mm to 1.736N / mm, with the specific value increasing quadratically with the wire diameter.

[0130] The calculation process is as follows:

[0131] The overall stiffness k is calculated using the formula k = EA / L = (E·πd²) / 4L. In an environment of 20℃, the longitudinal elastic modulus E of SUS304 stainless steel is 193000 MPa to 194020 MPa. When the wire diameter d is 0.23 mm, kmin ≈ 386 N / m; when the wire diameter is 0.38 mm, kmat ≈ 1736 N / m.

[0132] In other embodiments, the single torque wire can also be implemented such that the outer diameter of the proximal end of the torque wire is larger than the outer diameter of the distal end (especially the bending stroke section 309). Here, the proximal end is the length range extending distally from the connection point of the torque wire with the second handle to approximately 1 / 3 to 1 / 2 of the length of the entire wire, and the distal end is the length range extending proximally from the connection point of the torque wire with the clamp cup to approximately 1 / 2 to 2 / 3 of the length of the entire wire. The outer diameter of the control wire 31 can gradually decrease along the distal direction, or it can have multiple segments that remain stable. The axial length of the largest outer diameter segment of the control wire 31 can be greater than or equal to the sum of the axial lengths of the remaining outer diameter segments, which helps to ensure torque transmission.

[0133] In some other embodiments, the implementation of a single torque wire may also be such that the hardness of the proximal end of the torque wire is greater than the hardness of the distal end of the torque wire (especially the bending stroke section 309), wherein the proximal end is the length range extending distally from the connection point of the torque wire with the second handle to approximately 1 / 3 to 1 / 2 of the length of the entire wire, and the distal end is the length range extending proximally from the connection point of the torque wire with the clamp cup to approximately 1 / 2 to 2 / 3 of the length of the entire wire.

[0134] Furthermore, based on the above embodiments, the cross-sectional shape of the torque wire is not limited to a circle; any arc with a different radius of curvature is acceptable, as long as the cross-sectional shape of the torque wire is a smooth curve. Similarly, a single torque wire is not limited to being composed of a single strand of wire; it can also be composed of multiple strands of wire wound together. The outer diameter and cross-sectional shape formed by multiple strands of wire are also applicable to the above situations.

[0135] Compared to ordinary steel wire, torque wire undergoes straightening and heat treatment, resulting in better torque transmission performance. (For example, in cases of long wire lengths, two ordinary steel wires rotating together are prone to tangling and knotting, making it difficult to transmit torque from the near end to the far end. Torque wire, however, can still transmit torque from the near end to the far end even when tangled.) Therefore, this embodiment uses torque wire, which can both satisfy the transmission of rotational torque to achieve the rotational requirements of the far-end device and also give the torque wire a certain degree of flexibility, allowing it to form a stroke difference within the bending section of the flexible tube 4 to meet the lateral rotation requirements of the end device 220.

[0136] The aforementioned comparison of torque transmission performance can be performed using a torsion testing machine. The core standard for torque testing methods typically follows "Metallic Materials - Torsion Testing Methods," such as GB / T239 or ASTM A938, but parameters need to be adjusted according to the actual application. For fine wires with a diameter less than 1 mm, the gauge length is often tested at a fixed value. Specific operational steps may include: sample preparation, machine configuration, test execution, and result analysis.

[0137] Sample preparation: Cut a 2300mm long steel wire and mark the middle 100mm as the test section using a marker. If the wire is thin, use a fixed gauge length to avoid sagging due to its own weight and affecting the measurement; check the surface for scratches and rust, and ensure that the material is uniform. For SUS304 material, confirm that there is no cold work hardening.

[0138] Machine configuration: Select a miniature V-groove clamp that can avoid damaging the fine wires, and adjust the clamping force to the lowest effective value to prevent slippage and flattening; the hydraulic testing machine needs to be preheated for 3 to 5 minutes, the sensor needs to be preheated for 5 minutes, and the torque and angle readings should be zeroed.

[0139] Test execution: Rotate the active chuck at a constant speed of 3r / min and record the torque-torsion angle curve; Since the breaking torque is usually between 0.02N·m and 0.1N·m, that is, the wire can be broken when the torque reaches this range, so it can be continued until the wire breaks, or until the number of torsions reaches the preset value, and the peak torque and total number of torsions data are saved.

[0140] Results analysis: If the fracture is near the clamp, such as at a distance of less than 0.54 mm, or if severe slippage is found, resampling and testing are required; if the fracture is located in the middle of the gauge length and there are no abnormal splits on the surface, then the data is valid.

[0141] Under the same conditions, the torque transmission efficiency of different steel wires can be compared by measuring the peak torque using the above test method. The higher the peak torque, the better the torque transmission performance.

[0142] Referring to Figure 16, in some other embodiments, the control element 3 is a grafted control wire. Specifically, the control element 3 includes two control wires 31, a fixing tube 33, and a torque wire 32. The distal end of the torque wire 32 is connected to the proximal ends of the two control wires 31 through the fixing tube 33. The stiffness of the torque wire 32 can be greater than that of the control wires 31. Rotating the torque wire 32 is relatively easy, and the torque wire 32 can transmit torque to the two control wires 31. At the same time, since the length of the control wires 31 can be set to be shorter, it is beneficial to avoid tangling between the control wires 31, thereby improving the operability of the control element 3. For example, the distance between the proximal end of the control wire 31 and the distal end of the flexible tube 4 is greater than or equal to 60 mm, which helps to ensure that the control wire 31 bends within the flexible tube 4.

[0143] Optionally, the overall length of the control element 3 is 700mm to 2300mm. The proximal end of the control wire 31 can be located on the proximal side of the first tube 1. The distal end of the control wire 31 forms a first connection point with the end device 220, and the proximal end of the control wire 31 forms a second connection point with the fixed tube 33. The ratio of the distance between the first connection point and the second connection point to the length of the control element 3 can be 1:38 to 1:3.3. Since the condition for the end device 220 to be able to rotate laterally is that the two control wires 31 can generate a stroke difference, and the first tube 1 is not easy to bend, the first connection point must be located at least on the proximal side of the first tube 1. The position of the second connection point must ensure that the control wire 31 is not easily tangled or knotted, thus preventing torque transmission. Therefore, the optimal distance between the second connection point and the distal end of the flexible tube 4 is between 60mm and 700mm.

[0144] For example, the fixing tube 33 is fixed to the proximal end of multiple control wires 31 by crimping the fixing tube 33; the fixing tube 33 is also fixed to the distal end of the torque wire 32 by crimping the fixing tube 33. The fixing tube 33 has a simple structure and can effectively fix the control wire 31 and the torque wire 32.

[0145] In some embodiments, referring to FIG21, the proximal end face of the fixing tube 33 is located on the distal end side of the distal end face of the lubrication tube 41, and the outer diameter of the fixing tube 33 is larger than the inner diameter of the lubrication tube 41. Since the fixing tube 33 is not easy to bend, placing the fixing tube 33 outside the lubrication tube 41 can prevent the fixing tube 33 from getting stuck in the lubrication tube 41 due to tilting when bending, thereby preventing the control member 3 from getting stuck.

[0146] Optionally, the biopsy device 100 may be a disposable biopsy forceps, generally divided along the proximal-distal direction. The biopsy device 100 may include a handle mechanism 230, a sheath assembly 110, and a forceps head assembly 120. Exemplarily, at least a portion of the angle adjustment mechanism 210 and the flexible tube 4 constitute the sheath assembly 110. The end effector 220 and the cup seat 10 constitute the forceps head assembly 120.

[0147] In a pair, a single-use biopsy forceps consists of a handle assembly, a sheath assembly, and a forceps head assembly. The forceps head assembly is connected to the handle assembly through the sheath assembly. The sheath assembly transmits the pushing and pulling force of the handle assembly to the forceps head assembly, controlling the opening and closing of the forceps cup and the grasping of the target tissue.

[0148] In existing biopsy forceps, the sheath assembly mainly consists of a sheath and a wire hook. The wire hook is located inside the sheath, with one end connected to the forceps cup in the forceps head assembly and the other end connected to the handle assembly. Utilizing the lever principle, the driving force can be directly transmitted to the forceps cup through the wire hook. Specifically, the wire hook consists of two wires that cross near the forceps cup, with the lower wire connected to the upper forceps cup and the upper wire connected to the lower forceps cup. However, because the wire hook is relatively thin, it is prone to shifting during pushing and pulling. The wire connected to the lower forceps cup will shift downwards, and the wire connected to the upper forceps cup will shift upwards, resulting in a reduced lever arm and lower force transmission efficiency. Ultimately, this reduces the clamping force of the forceps cup, making sampling more difficult for some patients and easily leading to tearing and bleeding.

[0149] Referring to Figures 1, 17-18, and 23, this embodiment provides a biopsy forceps, including a handle mechanism 230, a sheath assembly 110, and a forceps head assembly 120. Specifically, the handle mechanism 230 consists of a finger ring 234, a first handle 231, and a second handle 232. The sheath assembly 110 consists of a flexible tube 4, a lubrication tube 41, a guide tube 233, and a control component 3. The forceps head assembly 120 consists of a forceps cup 5, a pin 501, a washer 23, a cup seat 10, and a long pin. The flexible tube 4 is a hollow cylindrical structure. The control component 3 has a certain amount of space for movement inside the flexible tube 4. The proximal end of the control component 3 is press-fitted to the distal end of the guide tube 233, and the distal end of the control component 3 is connected to the tail hole 521 of the forceps cup 5. The forceps cup 5 and the washer 23 are press-fitted and hinged to the cup seat 10 via the pin 501. The clearance between the parts ensures that the forceps cup 5 can open and close normally. The proximal end of the cup seat 10 of the clamp head assembly 120 is welded to the distal end of the flexible tube 4 of the sheath assembly 110 to ensure that the cup seat 10 will not fall off. When the second handle 232 is pushed or pulled, it moves axially towards the proximal end. The second handle 232 transmits the pushing and pulling force to the control component 3 through the guide tube 233, and then the control component 3 transmits it to the clamp cup 5 of the clamp head assembly 120 to realize the opening and closing function of the clamp cup 5.

[0150] The working process of biopsy forceps: The forceps cup 5 is inserted into the gastrointestinal tract in a closed state and brought close to the tissue to be sampled. When the forceps cup 5 is at the tissue to be sampled, the second handle 232 is pushed to open the forceps cup 5. After the forceps cup 5 contacts the tissue to be sampled, the sliding handle is pulled back to close the forceps cup 5 and the tissue is removed. At this time, one sampling is completed.

[0151] As shown in Figures 23 and 24, the control element 3 includes two control wires 31 corresponding to a pair of clamp cups 5, with the distal ends of the two control wires 31 crossing at a first position 3101. The clamp head assembly 120 also includes a limiting structure 53 disposed between the two control wires 31, and the limiting structure 53 is located on the side away from the clamp cups 5 at the first position 3101. When the control element 3 is pulled, the limiting structure 53 abuts against the two control wires 31. For example, the limiting structure 53 can be a block-shaped or strip-shaped structure or other structural component that can be placed between the two control wires 31, as long as it can abut against the two control wires 31 when they shift, preventing their lever arm from decreasing. For example, the limiting structure 53 can be a structural component disposed within the cup holder 10. For example, when the limiting structure 53 is a structural component disposed within the cup holder 10, the limiting structure 53 includes a connecting part and a limiting part, the limiting structure 53 is connected to the cup holder 10 through the connecting part, and the limiting part is placed between the two control wires 31.

[0152] Preferably, as shown in Figure 23, the limiting structure 53 is a long pin, with its two ends serving as connecting parts and its body as the limiting part. The cup holder 10 has mounting holes that mate with the two ends of the long pin, and the long pin is fitted into the cup holder 10 through the connecting parts at both ends and the mounting holes. For example, an interference fit can be used to install the two ends of the long pin into the mounting holes on the cup holder 10.

[0153] To better understand the technical solution in this application, as shown in Figure 24, two control wires 31 form two intersecting first bent sections 301a and 301b at the first position 3101. When the two control wires 31 are pulled, the first bent sections 301a and 301b abut against the limiting structure 53 configured as a long pin. As shown in Figure 25, the movement of the clamp cup 5 can be simplified as a lever movement with the pin shaft 501 as the fulcrum. The tail hole 521 of the clamp cup 5 is stretched by the control member 3, generating a certain torque. When the clamp cup 5 clamps the tissue, this torque is converted into a biting force acting on the tissue. The projected distance from the center of the pin shaft 501 to the direction of the pulling force F is taken as the lever arm L1. When the structural dimensions of the clamp cup 5 and the pulling force provided by the handle mechanism 230 remain unchanged, the key factor determining the magnitude of the biting force of the clamp cup 5 is the length of the lever arm L1.

[0154] Since the control component 3 is a non-rigid component, it has a certain degree of elasticity. Under the pulling force of the handle mechanism 230, the control component 3 moves proximally and gradually approaches the inner wall of the flexible tube 4 on the same side, causing its lever arm L2 to decrease. In this embodiment, a long pin is set on the cup seat 10 to limit the two first bent sections 301a and 301b located at the first position 3101. As shown in Figure 24, when the control wire 31 is pulled and the clamp cup 5 is closed, under the limiting action of the long pin, the first bent section 301a of the first control wire 311 can be prevented from rotating clockwise and the first bent section 301b of the second control wire 312 can be prevented from rotating counterclockwise, thereby preventing the lever arm L1 from decreasing, ensuring its biting force, eliminating the need for repeated grasping of the target tissue, reducing tearing and bleeding, improving surgical efficiency, and reducing surgical time.

[0155] To further enhance the limiting effect of the limiting structure 53, in some embodiments, the limiting structure 53, configured as a long pin, is positioned on the central axis of the cup holder 10, meaning the projection center of the limiting structure 53 is located on the central axis of the cup holder 10. As shown in Figure 26, the two clamp cups 5 rotate around the pin shaft 501, and the tail holes 521 of the two clamp cups 5 are connected to the first bending sections 301a and 301b, respectively. When the long pin is located on the central axis of the cup holder 10, the long pin, the pin shaft 501, and the central axis of the cup holder 10 are all on the same straight line. Here, γ is half the maximum opening angle of the two clamp cups 5, and α is the angle between the first bending section 301 and the central axis of the cup holder 10. During operation, the tension at the second handle 232 is F0, and the length of the control wire 31 from the second handle 232 to the position of the long pin is L. The tension F0 at the second handle 232 is transmitted to the distal end of the flexible tube 4 by the tension F1 (since the steel wire will experience friction with the sheath during the pulling process inside the sheath, F1 is usually less than F0). Let the transmission efficiency of the tension F0 at the same length be k, and μ be the coefficient of friction between the steel wire and the long pin. Typically, both the long pin and the steel wire are made of steel. The static friction coefficient between steel without lubrication is 0.15, and the dynamic friction coefficient between steel without lubrication is 0.1. The static friction coefficient between steel with lubrication ranges from 0.1 to 0.12, and the dynamic friction coefficient between steel with lubrication ranges from 0.05 to 0.1.

[0156] Where F1=kF0; F2=F1cosα-μF1sinα; then the receiving force F3 at the tail hole can be obtained: F3=F2cosβ;

[0157] Substituting F2 into the equation, we get: F3=kF0cosβ[cosα-μsinα];

[0158] ∴F3=kF0sin(α+γ)[cosα-μsinα];

[0159] Since k, F0, and γ are all constants, we can let f(α) = sin(α + γ)[cosα - μsinα], and then we can find f(α). max And the corresponding α. Based on the existing opening and closing angle range of various types of pliers cups, which is usually 0°-60°, the corresponding γ can be obtained as 0°-30°. Then, according to the above formula, the angle range of α is calculated to be 27°-43°.

[0160] To verify that biopsy forceps with long pins achieve better occlusal action, the applicant conducted an experiment: Two groups of commonly used biopsy forceps samples were selected, designated as Group A and Group B. The samples in Groups A and B were of the same model and specifications, with each group containing 10 different models and specifications. All biopsy forceps samples in Group A were fitted with long pins, while all biopsy forceps samples in Group B were without long pins, following existing technology. A tensile force of 50N was applied to the operating end (handle assembly) of each sample, and the occlusal forceps cup occlusal forceps forceps occlusal forceps of different models and specifications were tested, thus obtaining occlusal force data for different models and specifications of biopsy forceps with and without long pins, as shown in Table 1 below:

[0161] Table 1. Comparison of biting force of different models and specifications of biopsy forceps with and without long pins.

[0162] In Table 1, 2.3, 1.8, and 2.8 in the "Serial Number" column represent the maximum outer diameter (unit: mm) of each pliers cup when closed; 6.5, 6.8, 5.8, 8.0, 5.6, and 8.5 in the "Material Name" column represent the maximum span (unit: mm) of each pliers cup when open; "Flat" indicates that the pliers cup opening is flat; "Toothed" indicates that the pliers cup opening is toothed.

[0163] As shown in Table 1 above, the bite force that can be achieved at the forceps cup with the long pin is significantly greater than that without the long pin. Furthermore, in commonly used biopsy forceps, the angle between the first bending section 301 and the central axis of the cup seat 10 is in the range of 30°-37°, which is the optimal installation position for the long pin.

[0164] As shown in Figure 27, a stop protrusion 13 is provided on the inner wall of the cup holder 10, and the stop protrusion 13 is located on the side of the long pin away from the clamp cup 5. The distal end of the flexible tube 4 extends at least partially into the cup holder 10. The stop protrusion 13 can limit the extension of the flexible tube 4, preventing the distal end of the flexible tube 4 from contacting the long pin. For example, the stop protrusion 13 can be a continuous annular structure, or an intermittent dot-like or columnar structure provided on the inner wall of the cup holder 10. That is, the stop protrusion 13 reduces the diameter of the inner cavity of the cup holder 10, so that the flexible tube 4 cannot continue to extend forward after encountering the stop protrusion 13. This setting can limit the extension length of the flexible tube 4 after entering the cup holder 10, preventing the flexible tube 4 from interfering with the limiting structure 53. In the biopsy device 100 proposed in this embodiment, the cup holder 10 can be an integral structure. The portion with the stop protrusion 13 is regarded as the first tube 1, and the section connected to the end device 220 on the distal side can be regarded as the second tube 2. The first tube 1 includes a first connecting part 12 and a first tube segment 11. The second tube 2 includes a second connecting part 22 and a second tube segment 21. The second tube segment 21 is connected to the first tube segment 11 to form an integral unit. The second connecting part 22 is used to connect the end device 220. The limiting structure 53 is located on the central axis L1 of the second tube 2.

[0165] As shown in Figure 28, the pin 501 is mounted on the cup holder 10, and the two clamp cups 5 are rotatably mounted on the pin 501. A washer 23 is fitted onto the pin 501 and positioned between the two clamp cups 5. This arrangement ensures precise closure of the pair of clamp cups 5, preventing gaps after closure. The washer 23 can be a circular ring fitted onto the pin 501; alternatively, it can be a long washer as shown in Figure 28, with one end of the washer away from the pin 501 extending towards the location of the long pin. The end of the washer 23 near the long pin also has a notch 2301 to avoid interference between the long pin and the washer 23. This notch 2301 design also limits the washer 23's movement on its surface, enhancing structural stability and preventing the washer 23 from swinging out and affecting operation.

[0166] The gasket 23 can also be a gasket as shown in Figure 22. The circular hole at the distal end of the gasket 23 is used to fit onto the pin 501, and the proximal end of the gasket 23 can also have an elongated hole for the limiting structure 53 to pass through. By providing the elongated hole, the gasket 23 can be adapted to various sizes of cup holders 10. The hole shape and overall shape of the gasket 23 can also be designed as other shapes, such as an elongated hole or a square hole, as long as the dimensions of the limiting structure 53 are met.

[0167] Furthermore, along the axial direction of the control wire 31, the distal end of each control wire 31 sequentially includes a first bending segment 301, a second bending segment 302, and a third bending segment 303 from its distal end to its proximal end; the first bending segments 301 of the two control wires 31 cross once at the first position 3101, and the third bending segments 303 of the two control wires 31 cross twice at the second position 3102, with the limiting structure 53 located between the first position 3101, the second position 3102, and the two second bending segments 302.

[0168] Specifically, as shown in Figure 29, taking one of the control wires of the control component as an example, to facilitate a clearer understanding of the technical solution in this application, four points, P1, P2, P3, and P4, are marked on the control wire along its axial direction. A first bending segment 301 is formed between P1 and P2, a second bending segment 302 is formed between P2 and P3, and a third bending segment 303 is formed between P3 and P4. In one embodiment, the first bending segment 301, the second bending segment 302, and the third bending segment 303 are all straight segments.

[0169] As shown in Figures 30 to 33, in some embodiments, the second bending segment 302 and the third bending segment 303 are both straight segments, while the first bending segment 301 is a curved segment. For example, the curved segment convexes outward in a direction away from the limiting structure 53. For example, the curved segment includes one or more smooth curves with a fixed radius of curvature, such as an arc; for example, the curved segment includes one or more smooth curves with gradually increasing radii of curvature, such as an involute, an elliptical circle, or a combination thereof; for example, the curved segment includes one or more smooth curves with gradually decreasing radii of curvature, such as an involute, an elliptical circle, or a combination thereof.

[0170] As shown in Figure 30, in one embodiment, the line connecting P1 and P2 is designated as S1 on the side where the long pin is located and S2 on the other side. The first bending segment 301 is an arc curve, with the center of the arc curve located on the S1 side. The second bending segment 302 and the third bending segment 303 are both straight line segments. The first bending segment 301 only needs to have a smooth curve protruding towards the S2 side, and it is not limited to a circular arc shape, as long as it connects smoothly with the second bending segment 302 at the junction P2.

[0171] Preferably, the first bending section 301 and the second bending section 302 are smoothly connected at the junction P2, which allows the control component 3 to operate smoothly without jamming during the opening and closing process.

[0172] Preferably, the horizontal distance between P1 and P2 can be greater than 1 mm, and the angle between the line connecting P1 and P2 and any vertical axis can be greater than 35°.

[0173] When the radius of curvature of the first bending segment 301 is a certain value, it means that the radius of curvature at each point of the first bending segment 301 is that value. It should be noted that if the shape of the first bending segment 301 is not an arc, the radius of curvature of the first bending segment 301 may be different. This design ensures that the lever arm L2 remains constant during the opening and closing of the clamp cup 5, while reducing interference and friction between the control component 3 and the long pin during the opening and closing of the clamp cup 5.

[0174] In some embodiments, the radius of curvature of the first bending segment 301 can vary in stages along the length of the line connecting P1 and P2 as it moves away from the long pin.

[0175] Preferably, as shown in Figure 31, point P5 is marked between P1 and P2, dividing the first bending segment 301 into two parts: the portion between P1 and P5 is the first bending portion 304, and the portion between P5 and P2 is the second bending portion 305. Along the length of the line connecting P1 and P2, the first bending portion 304 is located near the tail hole 521 of the clamp cup 5, and the second bending portion 305 is located near the long pin. The first bending portion 304 forms an arc with radius R1, and the second bending portion 305 forms an arc with radius R2; for example, radius R1 can be smaller than radius R2.

[0176] Preferably, the length of the first curved portion 304 in the length direction of the line connecting P1 and P2 is denoted as N1, and the length of the second curved portion 305 in the length direction of the line connecting P1 and P2 is denoted as N2. Then N1 can be less than N2, and the first curved portion 304 and the second curved portion 305 are smoothly connected at the junction P5, so that the clamp cup 5 can be easily and flexibly opened and closed without jamming.

[0177] Optionally, the first bending segment 301 is not limited to having two bending sections with different radii of curvature, but may also have more bending sections with different radii of curvature. The radii of curvature of these bending sections may increase or decrease as they move away from the long pin along the length of the line connecting P1 and P2.

[0178] Preferably, as shown in Figure 32, the first bending segment 301 is shaped like an involute, with its radius of curvature continuously increasing as it moves away from the long pin along the length of the line connecting P1 and P2. Alternatively, as shown in Figure 33, the first bending segment 301 is part of an ellipse, with its radius of curvature continuously increasing as it moves away from the long pin along the length of the line connecting P1 and P2. This arrangement allows the clamp cup 5 to open and close easily and flexibly without jamming. It should be noted that the bending portion with a continuously changing radius of curvature is not limited to an involute or an ellipse; any smooth curve whose radius of curvature continuously increases or decreases as it moves away from the long pin along the length of the line connecting P1 and P2 is acceptable.

[0179] In some embodiments, the first bending segment 301 and the third bending segment 303 are both straight segments, while the second bending segment 302 is a curved segment. For example, the curved segment protrudes outward in a direction away from the limiting structure 53. As shown in Figure 34, in one embodiment, the line connecting P2 and P3 is designated as S3 on the side where the long pin is located and S4 on the other side. The second bending segment 302 is an arc curve, and the center of the arc curve is located on the S3 side. The shapes of the first bending segment 301 and the third bending segment 303 are both straight segments. The second bending segment 302 only needs to have a smooth curve protruding towards the S4 side, and smoothly connect at the connection between P2 and the first bending segment 301, and at the connection between P3 and the third bending segment 303, and is not limited to an arc shape.

[0180] Preferably, the radius of curvature of the second bending segment 302 can be less than 1. A certain value for the radius of curvature of the second bending segment 302 means that the radius of curvature at each point of the second bending segment 302 is that value. It should be noted that if the shape of the second bending segment 302 is not an arc, the radius of curvature of the second bending segment 302 may be different. This configuration ensures that while increasing the lever arm L2, it minimizes the contact between the control component 3 and the long pin, further improving the opening and closing flexibility of the clamp cup 5.

[0181] In some embodiments, the radius of curvature of the second bending segment 302 can vary in stages along the length of the line connecting P2 and P3 as it moves away from the long pin. Preferably, as shown in FIG35, with point P6 marked between P2 and P3, the second bending segment 302 is divided into two parts: a third bending portion 306 between P2 and P6, and a fourth bending portion 307 between P6 and P3. Along the length of the line connecting P2 and P3, the third bending portion 306 is located near the long pin, and the fourth bending portion 307 is located near the third bending segment 303. The third bending portion 306 forms an arc with radius R3, and the fourth bending portion 307 forms an arc with radius R4, wherein radius R3 can be greater than radius R4.

[0182] Preferably, the length of the third bend 306 in the length direction of the line connecting P2 and P3 is denoted as N3, and the length of the fourth bend 307 in the length direction of the line connecting P2 and P3 is denoted as N4. N3 can be less than N4, and the third bend 306 and the fourth bend 307 are smoothly connected at the junction P6, so that the clamp cup 5 can be opened and closed easily and flexibly without jamming.

[0183] Optionally, the second bending segment 302 is not limited to having two bending sections with different radii of curvature, but may also have more bending sections with different radii of curvature, the radii of curvature of these bending sections continuously increasing or decreasing as they move away from the long pin in the length direction of the line connecting P2 and P3.

[0184] Preferably, as shown in Figure 36, the shape of the second bending segment 302 can be an involute, with its radius of curvature continuously increasing away from the long pin along the length of the line connecting P2 and P3. Alternatively, as shown in Figure 37, the shape of the second bending segment 302 can be a portion of an ellipse, with its radius of curvature continuously increasing away from the long pin along the length of the line connecting P2 and P3.

[0185] This design allows the clamp cup 5 to open and close easily and flexibly without jamming. It should be noted that the curved portion with a continuously changing radius of curvature is not limited to an involute or an ellipse; any smooth curve whose radius of curvature continuously increases or decreases along the length of the line connecting P2 and P3 as it moves away from the long pin is acceptable.

[0186] In some embodiments, the third bending segment 303 is a straight segment, while the first bending segment 301 and the second bending segment 302 are both curved segments. For example, the curved segments bulge outward in a direction away from the limiting structure 53.

[0187] As shown in Figure 38, in one embodiment, P1 and P3 are connected by a line, with the side containing the long pin denoted as S6 and the other side as S5. The radii of curvature of the first bending segment 301 and the second bending segment 302 can increase along the straight line connecting P1 and P3, opposite to the side S6 where the long pin is located (S5). Preferably, the first bending segment 301 and the second bending segment 302 can be combined to form an arc with a radius of R, and its radius of curvature can continuously change as it moves away from the long pin along the length of the line connecting P1 and P3.

[0188] Alternatively, as shown in Figure 39, the shape formed by the combination of the first bending segment 301 and the second bending segment 302 can be an involute, whose radius of curvature increases continuously as it moves away from the long pin along the length direction of the line connecting P1 and P3.

[0189] Instead, as shown in Figure 40, the shape formed by the combination of the first bending segment 301 and the second bending segment 302 is part of an elliptical circumference, and the radius of curvature increases continuously as it moves away from the long pin along the length direction of the line connecting P1 and P3.

[0190] It should be noted that the shape formed by the combination of the first bending segment 301 and the second bending segment 302 is not limited to the same arc, involute, or ellipse. A combination of different smooth curves for the first bending segment 301 and the second bending segment 302 can be used, ensuring a smooth transition at the junction point P2. Furthermore, the bending point with a continuously changing radius of curvature is not limited to an involute or ellipse; any smooth curve whose radius of curvature continuously increases or decreases along the length of the line connecting P1 and P3 as it moves away from the long pin is acceptable.

[0191] In some embodiments, the first bending segment 301 is a straight segment, while the second bending segment 302 and the third bending segment 303 are both curved segments. For example, the curved segments bulge outward in a direction away from the limiting structure 53.

[0192] As shown in Figure 41, P2 and P4 are connected by a line. The side where the long pin is located is denoted as S7, and the other side is denoted as S8. In one embodiment, the radius of curvature of the second bending segment 302 and the third bending segment 303 can increase along the straight line connecting P2 and P4 and the opposite side S8 of the side where the long pin is located, S7.

[0193] Preferably, the shape formed by the combination of the second bending segment 302 and the third bending segment 303 can be an arc, the radius of curvature of which increases continuously as it moves away from the long pin along the length direction of the line connecting P2 and P4.

[0194] Alternatively, as shown in Figure 42, the shape formed by the combination of the second bending segment 302 and the third bending segment 303 can be an involute, whose radius of curvature increases continuously as it moves away from the long pin along the length direction of the line connecting P2 and P4.

[0195] Alternatively, as shown in Figure 43, the shape formed by the combination of the second bending segment 302 and the third bending segment 303 can be part of an elliptical circumference, with the radius of curvature continuously increasing as it moves away from the long pin along the length direction of the line connecting P2 and P4.

[0196] It should be noted that the shape formed by the combination of the second bending segment 302 and the third bending segment 303 is not limited to the same arc, involute, or ellipse. A combination of different smooth curves for the second bending segment 302 and the third bending segment 303 can be used, ensuring a smooth transition at the junction point P3. Furthermore, the bending point with a continuously changing radius of curvature is not limited to an involute or ellipse; any smooth curve whose radius of curvature continuously increases or decreases along the length of the line connecting P2 and P4 as it moves away from the long pin is acceptable.

[0197] In some implementations, the first bending segment 301, the second bending segment 302, and the third bending segment 303 are all curved segments.

[0198] As shown in Figure 44, P1 and P4 are connected by a line. The side where the long pin is located is denoted as S9, and the other side is denoted as S10. In one embodiment, the radius of curvature of the first bending segment 301, the second bending segment 302, and the third bending segment 303 can be increased along the straight line connecting P1 and P4 and the opposite side S10 of the side where the long pin is located, S9.

[0199] Preferably, the shape formed by the combination of the first bending segment 301, the second bending segment 302 and the third bending segment 303 is an arc, and its radius of curvature increases continuously as it moves away from the long pin along the length direction of the line connecting P1 and P4.

[0200] Instead, as shown in Figure 45, the shape formed by the combination of the first bending segment 301, the second bending segment 302 and the third bending segment 303 is an involute, whose radius of curvature increases continuously as it moves away from the long pin along the length direction of the line connecting P1 and P4.

[0201] Instead, as shown in Figure 46, the shape formed by the combination of the first bending segment 301, the second bending segment 302 and the third bending segment 303 is part of an elliptical circumference, and the radius of curvature increases continuously as it moves away from the long pin along the length direction of the line connecting P1 and P4.

[0202] It should be noted that the shape formed by the combination of the first bending segment 301, the second bending segment 302, and the third bending segment 303 is not limited to the same arc, involute, or ellipse. A combination of different smooth curves can be used, ensuring a smooth transition at the intersection points P2 and P3. Furthermore, the bending point with a continuously changing radius of curvature is not limited to an involute or ellipse; any smooth curve whose radius of curvature continuously increases or decreases along the length of the line connecting P1 and P4 as it moves away from the long pin is acceptable.

[0203] In the above embodiments, when the first bending segment 301 is curved, compared to a straight line, the curved shape can dynamically adjust the force transmission according to the opening and closing angle of the clamp cup 5, making the force transmission more uniform and efficient. Simultaneously, the curved shape makes the connection point P2 between the first bending segment 301 and the second bending segment 302 less prone to breakage when under stress.

[0204] In the above embodiments, when the second bending section 302 is curved, it can better adapt to the complex motion trajectory during the opening and closing of the clamp cup 5. A straight design may not be able to fully match the movement direction of the control component 3, causing the control component 3 to experience jamming or uneven movement during movement. The curved shape, by optimizing the cooperation with the long pin, can make the movement of the control component 3 smoother and reduce resistance during movement. At the same time, a straight design may cause the control component 3 to have direct hard contact with the long pin during movement, while the curved shape, by changing the contact angle and contact point, can effectively reduce friction, thereby making the wire hook move more smoothly.

[0205] In the above embodiments, when the third bending segment 303 is curved, compared to a straight line, the curved design allows the control component 3 to move more smoothly during operation, reducing abrupt changes or stuttering that may occur due to a straight line design. Especially in the later stages of opening and closing the clamp cup 5, the curved design can better adapt to the movement trajectory of the control component 3, ensuring the smoothness of overall operation.

[0206] In summary, the tissue sampling forceps in this application, while ensuring product efficiency and cost, utilizes a long pin for limiting to guarantee the required biting force. Compared with conventional wire hook structures, the biting force is greater and tissue sampling is simpler. At the same time, the number of bends and the bending shape of the control component 3 have been improved, taking into account the product's opening and closing flexibility.

[0207] For example, the cup holder 10 may include a first tube 1 and a second tube 2. The first tube 1 includes a first tube segment 11 and a first connecting portion 12, and the second tube 2 includes a second tube segment 21 and a second connecting portion 22. The second tube segment 21 is rotatably connected to the first tube segment 11, the distal end of the flexible tube 4 is connected to the first connecting portion 12 of the first tube 1, and the two clamp cups 5 are respectively rotatably connected to the second connecting portion 22. The rotation structure and rotation principle between the first tube segment 11 and the second tube segment 21 can refer to the above-described embodiment.

[0208] In the embodiments disclosed above, unless otherwise explicitly specified and limited, the execution order of each step is not restricted. For example, they can be executed in parallel or sequentially in different orders. The sub-steps of each step can also be executed alternately. Various forms of processes described above can be used, and steps can be reordered, added, or deleted, as long as the desired result of the technical solution provided in this application can be achieved, and this application does not impose any restrictions here.

[0209] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0210] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. An angle adjustment mechanism for controlling an end effector, characterized in that, The angle adjustment mechanism includes: The first pipe includes a first connecting part and a first pipe section; The second pipe includes a second connecting portion and a second pipe segment, the second pipe segment being rotatably connected to the first pipe segment, and the second connecting portion being used to connect the end fitting; and A control element is disposed in the first tube and the second tube, the distal end of the control element is connected to the end device, the control element is used to drive the end device and the second tube to rotate relative to the first tube, and the control element is used to drive the end device to deviate from the rotation axis of the second tube relative to the second tube.

2. The angle adjustment mechanism according to claim 1, wherein, The proximal end of the first connecting part is provided with a flexible tube, and a lubrication tube is provided inside the flexible tube. At least a portion of the control element passes through the channel of the lubrication tube, and the inner diameter of the channel is larger than the outer diameter of the control element. The control element includes at least two control wires, each control wire including a bending stroke segment located within the flexible tube; based on the parallel orientation of the at least two bending stroke segments, when the flexible tube is in a flexible bending state, a stroke difference can exist between the at least two control wires to offset the end device relative to the second tube.

3. The angle adjustment mechanism according to claim 1 or 2, wherein, The control element includes two control wires, which are two torque wires. The proximal ends of the two torque wires are fixed together and used for external connection, and the distal ends of the two torque wires are respectively connected to the end device.

4. The angle adjustment mechanism according to claim 3, wherein, The ratio between the outer diameter of the torque wire and the inner diameter of the channel is in the range of 1:3.8 to 1:2.

8.

5. The angle adjustment mechanism according to claim 3, wherein, The stiffness of the near end of the torque wire is greater than the stiffness of the bending stroke section of the torque wire. Alternatively, the outer diameter of the proximal end of the torque wire is larger than the outer diameter of the bending stroke section of the torque wire; Alternatively, the hardness of the proximal end of the torque wire is greater than the hardness of the bending stroke section of the torque wire.

6. The angle adjustment mechanism according to claim 1 or 2, wherein, The control element includes two control wires, the distal ends of which are respectively connected to the end device. The control element also includes a torque wire and a fixing tube, the distal end of which is connected to the proximal ends of the two control wires through the fixing tube.

7. The angle adjustment mechanism according to claim 6, wherein, The proximal end of the control wire is located on the proximal side of the first tube, the distal end of the control wire forms a first connection point with the end device, and the proximal end of the control wire forms a second connection point with the fixed tube. The ratio of the distance between the first connection point and the second connection point to the length of the control element is 1:38 to 1:3.

3.

8. The angle adjustment mechanism according to claim 6 or 7, wherein, The proximal end face of the fixed tube is located on the distal side of the distal end face of the lubricating tube, and the outer diameter of the fixed tube is larger than the inner diameter of the lubricating tube.

9. The angle adjustment mechanism according to any one of claims 1 to 7, wherein, The second pipe segment includes a receiving pipe segment and a snap-fit ​​part arranged sequentially from the distal end to the proximal end. The first pipe segment includes an inner limiting ring, which restricts the receiving pipe segment and the snap-fit ​​part along the proximal-distal direction.

10. The angle adjustment mechanism according to claim 9, wherein, The latching part is separately disposed from the receiving tube section. The latching part includes an integrally disposed transition tube section, a gap tube section, and at least two circumferentially spaced latching teeth along the proximal end of the gap tube section. The proximal end of the latching teeth is hooked onto the inner limiting ring. The transition tube section is built into the proximal end of the receiving tube section. The transition tube section is tapered. Alternatively, the latching part is integrally formed with the receiving tube section. The latching part includes a gap tube section connected to the receiving tube section and at least two circumferentially spaced teeth arranged along the proximal end of the gap tube section. The proximal end of the teeth is hooked onto the inner limiting ring, and the teeth and the receiving tube section are smoothly connected by a tapered transition section.

11. The angle adjustment mechanism according to claim 9, wherein, The latching part is separately disposed from the receiving tube section. The latching part includes an integrally disposed transition tube section, a gap tube section, and a continuous and complete ring edge folded over the gap tube section. The gap tube section is connected to the receiving tube section through the transition tube section. A limiting through hole is formed in the middle of the inner limiting ring for the gap tube section to pass through. The outer diameter of the ring edge is larger than the diameter of the limiting through hole, and the outer diameter of the receiving tube section is larger than the outer diameter of the gap tube section.

12. The angle adjustment mechanism according to claim 11, wherein, The transition pipe section and the gap pipe section form a cylindrical shape that is integrally formed. The accommodating pipe section includes an inner pipe and an outer pipe. The inner pipe is embedded between the outer pipe and the transition pipe section. An annular groove is formed between the inner pipe and the ring edge for the inner limiting ring to be embedded.

13. The angle adjustment mechanism according to claim 12, wherein, The distal end of the built-in tube forms a first annular protrusion that abuts against the distal end surface of the transition tube section. The inner diameter of the first annular protrusion is larger than the inner diameter of the transition tube section and smaller than the outer diameter of the transition tube section.

14. The angle adjustment mechanism according to claim 13, wherein, The proximal end of the built-in tube forms a second annular protrusion that abuts against the proximal end face of the external tube. An annular groove for the inner limiting ring to be embedded is formed between the proximal end face of the second annular protrusion and the distal end face of the annular edge. The outer diameter of the second annular protrusion is larger than the diameter of the limiting through hole and smaller than the outer diameter of the external tube.

15. A biopsy device, characterized in that, include: End fittings, including at least two clamp cups; and According to any one of claims 1 to 14, the two clamping cups are rotatably connected to the second connecting part and the two clamping cups have an open state and a clamping state; the distal ends of the two control wires of the control member are respectively connected to the two clamping cups to control the opening, closing, rotation and lateral rotation of the clamping cups.

16. The biopsy apparatus according to claim 15, wherein, It also includes a first handle and a second handle, the first handle being rotatably connected to the proximal end of the flexible tube; the second handle being connected to the proximal end of the control member, and the second handle being slidably connected to the first handle; by sliding the second handle, the control member drives the clamp cup to open and close; by rotating the first handle, the control member drives the clamp cup to rotate.

17. A method for operating an angle adjustment mechanism, characterized in that, The angle adjustment mechanism is the angle adjustment mechanism as described in any one of claims 1 to 14, and the method includes: By rotating the control component, the end device and the second tube are driven to rotate relative to the first tube about the rotation axis; The end device is rotated about a lateral rotation axis that is angled relative to the axis of rotation; and The control unit controls the end effector to perform working actions.

18. The method for operating the angle adjustment mechanism according to claim 17, wherein, The end device includes a pair of clamp cups rotatably mounted on the second connecting part via a pin, and the control element includes two control wires, the proximal ends of which are respectively connected to the pair of clamp cups; When the clamp cups are in the open state, one of the clamp cups, when subjected to force, can drive the other clamp cup to rotate in the same direction around the axis of the pin, and the distal ends of the two control wires form a stroke difference in the axial direction.

19. A biopsy device, characterized in that, include: End fittings, including at least two clamp cups; The first pipe includes a first connecting part and a first pipe section; The second pipe includes a second connecting part and a second pipe segment, the second pipe segment being connected to the first pipe segment, and the second connecting part being used to connect the end device; A control element is inserted through the first tube and the second tube, the distal end of the control element is connected to the end device, and the control element includes two control wires that are intersected at a first position; as well as A limiting structure; the limiting structure is located near the first position and between the two control wires, and is used to abut against the two control wires.

20. The biopsy apparatus according to claim 19, wherein, The control wire includes a first bent section that can abut against the limiting structure, the limiting structure being located on the central axis of the second tube, and when the limiting structure abuts against the first bent section, the included angle between the first bent section and the central axis is in the range of 27° to 43°.

21. The biopsy apparatus according to claim 20, wherein, The control wire includes a first bending segment, a second bending segment, and a third bending segment arranged sequentially along the proximal-distal direction. The two control wires intersect twice at a second position, which is located near the first position. The limiting mechanism is located far from the second position and is located between the two second bending segments.

22. The biopsy device according to claim 21, wherein, The second bending segment is a curved segment, the third bending segment is a curved segment or a straight segment, and the first bending segment is a curved segment or a straight segment; or, The second bending segment is a straight segment, the third bending segment is a straight segment, and the first bending segment is a curved segment.

23. The biopsy device according to claim 22, wherein, The curved segment bulges outward in a direction away from the limiting structure; The curve segment includes one or more smooth curves with a fixed radius of curvature, or the curve segment includes one or more smooth curves with a gradually increasing radius of curvature, or the curve segment includes one or more smooth curves with a gradually decreasing radius of curvature.

24. The biopsy apparatus according to claim 19, wherein, It also includes a gasket and a pin, the pin being connected to the second tube, the gasket being disposed on the pin, and the gasket having a notch for avoiding the limiting structure.

25. The biopsy apparatus according to claim 19, wherein, The second pipe segment is rotatably connected to the first pipe segment, the distal end of the flexible pipe is connected to the first connecting part of the first pipe, and the two clamps are rotatably connected to the second connecting part respectively.

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