Clip instrument and operation method therefor

Abstract

Embodiments of the present specification provide a clip instrument and a control method therefor. The clip instrument comprises a sheath tube, a clamp arm, and a locking member. The sheath tube comprises a channel, and the clamp arm comprises at least two clamping portions, the at least two clamping portions including a locked state. The locking member is used for limiting relative displacement of the at least two clamping portions in the locked state. After the locking member locks the at least two clamping portions, the locking member, together with the at least two clamping portions, is released from the sheath tube.

Description

A clamp device and its operation method Cross-references

[0001] This application claims priority to Chinese application No. 202410139944.0 filed on January 31, 2024, and claims priority to Chinese application No. 202410693881.3 filed on May 30, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This specification relates to the field of medical devices, and in particular to a clamp device and an operating method thereof. Background Art

[0003] Endoscopic hemostatic clips are medical devices used to stop bleeding during endoscopic surgery. They are commonly used during surgeries on internal organs such as the gastrointestinal tract and esophagus to control bleeding and maintain a clear surgical field of view. These clips play a key role in endoscopic surgery, helping to reduce surgical complications and improve surgical safety and effectiveness. The design of endoscopic hemostatic clips must take into account the special requirements of endoscopic surgery, allowing surgeons to operate precisely within the confined surgical space. However, in actual clinical surgery, hemostatic clips carry risks such as damage to surrounding tissues and low wound positioning accuracy. Summary of the Invention

[0004] One or more embodiments of the present specification provide a clamp instrument, comprising: a clamp arm, the clamp arm comprising at least two clamping parts; a sheath, the sheath comprising a channel; a locking member, the locking member being releasably disposed in the channel of the sheath, and when the locking member cooperates with the at least two clamping parts, the at least two clamping parts are in a locked state.

[0005] In some embodiments, in the locked state, the locking member is located between the at least two clamping portions.

[0006] In some embodiments, the clamping arm includes at least two extensions, and the clamping portion is releasably disposed at the distal end of the extension; when the clamping portion is in an open state, the locking member is located between the at least two extensions.

[0007] In some embodiments, a clamping space is formed between the at least two clamping parts, and a locked part is provided on a side of the clamping part facing the clamping space; when the locking member cooperates with the locked part, the at least two clamping parts are locked.

[0008] In some embodiments, the clamping arm includes at least two extensions, and the clamping portion is releasably provided at the distal end of the extension; the clamping portion includes an interlocking structure, the interlocking structure is releasably connected to the extension, and the interlocking structure is operably matched with the locking member; and, when the interlocking structure cooperates with the locking member, the at least two clamping portions are in a locked state.

[0009] In some embodiments, the locking member includes a stop structure, the clamping portion includes an interlocking structure, and the interlocking structure includes a locked portion. When the locked portion is subjected to a force greater than or equal to a third preset force value applied by the stop structure in a first direction, the locked portion undergoes elastic deformation. After the locked portion moves to the locking position of the stop structure, the locking member is locked with the locked portion. Moreover, when the locked portion is subjected to a force applied by the stop structure in a second direction, the deformation of the locked portion is restricted. The second direction is the relative movement direction of the stop structure and the locked portion, and the first direction is not parallel to the second direction.

[0010] In some embodiments, the sheath includes a resisting structure, which releasably limits the locking member within the sheath channel. When the clamping portion is in an open state, a closed state, and a locked state, the locking member cooperates with the resisting structure and is located within the sheath channel; when the clamping portion is in a released state, the locking member is released from the resisting structure and is located outside the sheath channel.

[0011] In some embodiments, the sheath comprises a fixed section and a rotating section, a proximal end of the rotating section is rotatably connected to a distal end of the fixed section, and the rotating section is configured to be rotatable around the sheath axis.

[0012] One or more embodiments of the present specification provide an operating method for a clamp instrument, which is applied to a clamp instrument as described in any one of the above items, and the operating method includes: controlling at least two clamping parts of the clamp arm to open; controlling the at least two clamping parts of the clamp arm to close; controlling the clamp arm to move from the distal end to the proximal end until the at least two clamping parts cooperate with the locking member, so that the at least two clamping parts are locked; when the clamping part moves from the distal end to the proximal end until it contacts the locking member, the at least two clamping parts continue to move proximally, actuating the locking member to release the sheath; controlling the at least two clamping parts to release from the sheath.

[0013] In some embodiments, the beneficial effects of the clamp instrument include but are not limited to: the locking member is located inside the sheath and can be isolated from the external environment, reducing the risk of failure due to interference from external factors (such as blood, tissue fragments), and preventing the locking member from accidentally loosening. The locking member is arranged on the inner side of the clamping portion. Compared with the traditional clamping portion, the retention length of the locking member and the clamping portion can be reduced by 30% to 70%, effectively improving the surgical operating field and reducing the difficulty of the operation. The locking member is arranged on the inner side of the extension portion, which solves the problem of the limited opening angle of the extension portion, that is, the opening angle of the extension portion is not limited by the locking member, so that the clamping portion obtains a larger clamping space. By providing an interlocking structure that cooperates with the extension portion and the locking member at the same time, the connection and locking functions are integrated into the interlocking structure, making the overall structure more compact and the clamping portion smaller in size. The small-sized locking piece and clamping part are less likely to be disturbed by the environment in the narrow space in the body, thereby avoiding the accidental separation of the clamping part due to external force; the locked part is arranged on the side of the clamping part facing the clamping space, that is, the locking piece locks the locked part on the inner side of at least two clamping parts, and will not occupy the space outside the clamping part, so that the structure of the clamping part is more compact and small after closing, thereby reducing the surgical field of view blocked by the clamping part. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] This specification will be further described in the form of exemplary embodiments, which will be described in detail with reference to the accompanying drawings. These embodiments are not limiting, and in these embodiments, like numbers represent like structures, wherein:

[0015] FIG1 is an exemplary structural diagram of a clip instrument according to some embodiments of the present specification;

[0016] FIG2 is an exemplary structural block diagram of a clip device according to some embodiments of the present specification;

[0017] FIG3 is an exemplary structural block diagram of a clip device according to some embodiments of the present specification;

[0018] FIG4 is an exemplary structural block diagram of a clip device according to other embodiments of the present specification;

[0019] FIG5 is an exemplary structural block diagram of a clip device according to yet other embodiments of the present specification;

[0020] FIG6 is an exemplary exploded view of the structure of the clamping arm and the conveying portion according to some embodiments of the present specification;

[0021] 7 is a partial cross-sectional view of a clamping arm and a conveying portion according to some embodiments of the present specification;

[0022] FIG8 is an exemplary structural diagram of a clamping portion according to some embodiments of the present specification;

[0023] FIG9 is an exemplary side view of a clamping portion according to some embodiments of the present specification;

[0024] FIG10 is an exemplary structural diagram of a clamping portion according to other embodiments of the present specification;

[0025] FIG11 is an exemplary structural diagram of a locking member according to some embodiments of the present specification;

[0026] FIG12 is a partial cross-sectional view of a locking member according to some embodiments of the present specification;

[0027] FIG13 is an exemplary structural diagram of a locking member and a clamping portion locked according to some embodiments of this specification;

[0028] FIG14 is a cross-sectional view of a locking member and a clamping portion locked according to some embodiments of the present specification;

[0029] FIG15 is an exemplary structural diagram of the distal end of the sheath according to some embodiments of the present specification;

[0030] 16 is an exemplary structural diagram of a locking member and a sheath tube according to some embodiments of the present specification;

[0031] FIG17 is a cross-sectional view of a locking member engaged with a sheath according to some embodiments of the present specification;

[0032] FIG18 is a cross-sectional view of a clamping portion in a pre-locking state according to some embodiments of the present specification;

[0033] FIG19 is a schematic structural diagram of a clamping portion in a pre-locking state according to some embodiments of this specification;

[0034] FIG20 is a cross-sectional view of a clamping portion in a locked state according to some embodiments of the present specification;

[0035] FIG21 is a schematic structural diagram of a clamping portion in a locked state according to some embodiments of this specification;

[0036] FIG22 is an exemplary structural diagram of the distal end of the sheath according to other embodiments of the present specification;

[0037] FIG23 is an exemplary structural diagram of a locking member and a sheath tube according to other embodiments of the present specification;

[0038] FIG24 is a cross-sectional view of the locking member and the sheath according to other embodiments of the present specification;

[0039] FIG25 is a cross-sectional view of a clamping portion in a pre-locking state according to other embodiments of the present specification;

[0040] FIG26 is a cross-sectional view of a locking member and a sheath tube released according to other embodiments of the present specification;

[0041] FIG27 is a cross-sectional view of a clamping portion in a locked state according to other embodiments of the present specification;

[0042] FIG28 is an exemplary structural diagram of an extension portion according to some embodiments of the present specification;

[0043] FIG29 is an isometric view of the engagement of the clamping portion and the extension portion according to some embodiments of the present specification;

[0044] FIG30 is a front view of the clamping portion and the extension portion in cooperation according to some embodiments of the present specification, wherein the locked portion is hidden;

[0045] FIG31 is a side view of the clamping portion and the extension portion according to some embodiments of the present specification;

[0046] FIG32 is an exemplary structural diagram of a first tube member of a sheath tube according to some embodiments of the present specification;

[0047] FIG33 is an exemplary structural diagram of a second tube of a sheath tube according to some embodiments of the present specification;

[0048] FIG34 is an exemplary structural diagram of the cooperation between the first tube, the second tube, and the locking member according to some embodiments of this specification;

[0049] FIG35 is an exemplary structural diagram of a second tube of a sheath tube according to other embodiments of the present specification;

[0050] FIG36 is an exemplary structural diagram of the cooperation between the first tube, the second tube, and the locking member according to other embodiments of this specification;

[0051] FIG37 is an exemplary structural diagram of a clip instrument in an open state according to some embodiments of the present specification;

[0052] FIG38 is a partial cross-sectional view of a clip device in an open state according to some embodiments of the present specification;

[0053] FIG39 is an exemplary structural diagram of a clip device in a closed state according to some embodiments of the present specification;

[0054] FIG40 is a partial cross-sectional view of a clip device in a closed state according to some embodiments of the present specification;

[0055] FIG41 is an exemplary structural diagram of a locking member and a sheath tube released according to some embodiments of the present specification;

[0056] FIG42 is a partial cross-sectional view of a locking member and a sheath tube released according to some embodiments of the present specification;

[0057] FIG43 is an exemplary structural diagram of a clamping portion in a pre-locking state according to some embodiments of this specification;

[0058] FIG44 is a partial enlarged view of the clip device in area A according to some embodiments of FIG43;

[0059] FIG45 is an exemplary structural diagram of a clamping portion in a locked state according to some embodiments of the present specification;

[0060] FIG46 is a partial cross-sectional view of a clamping portion in a locked state according to some embodiments of the present specification;

[0061] FIG47 is a partial enlarged view of the clip device at area B according to some embodiments of FIG46 ;

[0062] FIG48 is an exemplary structural diagram of a clamping portion and a locking member being released from a sheath according to some embodiments of the present specification;

[0063] 49 is a partial cross-sectional view of a clamping portion and a locking member being released from a sheath according to some embodiments of the present specification;

[0064] FIG50 is an exemplary structural diagram of a clamping portion and a locking member being released from a sheath according to some embodiments of the present specification;

[0065] FIG51 is an exemplary structural block diagram of a clip device according to some embodiments of the present specification;

[0066] FIG52 is an exemplary structural block diagram of a clip device according to other embodiments of the present specification;

[0067] FIG53 is an exemplary structural block diagram of a clip device according to yet other embodiments of the present specification;

[0068] FIG54 is a partial cross-sectional view of a clamping arm and a conveying portion according to some embodiments of the present specification;

[0069] FIG55 is an exemplary structural diagram of an extension portion according to some embodiments of the present specification;

[0070] FIG56 is an exemplary structural diagram of a clamping portion according to some embodiments of the present specification;

[0071] FIG57 is an exemplary structural diagram of the cooperation between the extension portion and the clamping portion according to some embodiments of the present specification;

[0072] FIG58 is an exemplary structural diagram of a locking member according to some embodiments of the present specification;

[0073] FIG59 is an exemplary structural diagram of a locking member and a clamping portion locked according to some embodiments of this specification;

[0074] FIG60 is a partial cross-sectional view of a locking member and a clamping portion locked according to some embodiments of the present specification;

[0075] FIG61 is an exemplary structural diagram of the distal end of the sheath according to some embodiments of the present specification;

[0076] FIG62 is a partial cross-sectional view of the distal end of the sheath according to some embodiments of FIG61 ;

[0077] FIG63 is an axial view of the distal end of the sheath according to some embodiments of FIG61;

[0078] FIG64 is an exemplary structural diagram of a locking member and a sheath tube according to some embodiments of the present specification;

[0079] FIG65 is a cross-sectional view of the locking member and the sheath according to some embodiments of FIG64;

[0080] FIG66 is an axial view of the locking member engaged with the sheath according to some embodiments of FIG64 ;

[0081] FIG67 is an exemplary structural diagram of a clip instrument in an open state according to some embodiments of the present specification;

[0082] FIG68 is an exemplary structural diagram of a clip device in a closed state according to some embodiments of the present specification;

[0083] FIG69 is an exemplary structural diagram of a clip instrument in a pre-locking state according to some embodiments of the present specification;

[0084] FIG70 is a partial enlarged view of region A of the clip apparatus shown in FIG69 in a pre-locked state;

[0085] FIG71 is an exemplary structural diagram of a distal end structure of a clip instrument according to some embodiments of the present specification;

[0086] FIG72 is a cross-sectional view of the clip apparatus shown in FIG71 taken along section line BB, wherein the clip arm is in a pre-locked state;

[0087] FIG73 is a cross-sectional view of the clip apparatus shown in FIG71 taken along section line BB, wherein the clip arm is in a locked state;

[0088] FIG74 is an exemplary structural diagram of a distal end structure of a clip instrument according to some embodiments of the present specification;

[0089] FIG75 is a cross-sectional view of the clip apparatus shown in FIG74 taken along section line CC, wherein the extension portion and the clamping portion are in a released state;

[0090] FIG76 is an exemplary structural diagram of a clip instrument in a released state according to some embodiments of the present specification;

[0091] FIG77 is an exemplary structural diagram of a clamping portion according to some embodiments of the present specification;

[0092] FIG78 is an exemplary structural diagram of a clamping portion and an extending portion according to some embodiments of the present specification;

[0093] FIG79 is an exemplary structural diagram of a locking member according to some embodiments of the present specification;

[0094] FIG80 is an exemplary structural diagram of a locking member and a clamping portion locked according to some embodiments of this specification;

[0095] FIG81 is a partial cross-sectional view of a locking member and a clamping portion locked according to some embodiments of the present specification;

[0096] FIG82 is an exemplary structural diagram of the distal end of the sheath according to some embodiments of the present specification;

[0097] FIG83 is a partial cross-sectional view of the distal end of the sheath according to some embodiments of FIG82;

[0098] FIG84 is an axial view of the distal end of the sheath according to some embodiments of FIG82;

[0099] FIG85 is an exemplary structural diagram of a locking member and a sheath tube according to some embodiments of the present specification;

[0100] FIG86 is a cross-sectional view of the locking member and the sheath according to some embodiments of FIG85;

[0101] FIG87 is an axial view of the locking member engaged with the sheath according to some embodiments of FIG85 ;

[0102] FIG88 is an exemplary structural diagram of a distal end structure of a clip instrument according to some embodiments of the present specification;

[0103] FIG89 is a cross-sectional view of the clip apparatus according to FIG88 taken along section line DD, wherein the clip arm is in a pre-locked state;

[0104] FIG90 is a cross-sectional view of the clip apparatus according to FIG88 taken along section line DD, wherein the clip arm is in a locked state;

[0105] FIG91 is an exemplary structural diagram of a distal end structure of a clip instrument according to some embodiments of the present specification;

[0106] FIG92 is a cross-sectional view of the clip apparatus shown in FIG91 taken along section line EE, wherein the extension portion and the clamping portion are in a released state;

[0107] FIG. 93 is an exemplary flow chart illustrating a method of operating a clip instrument according to some embodiments of the present specification.

[0108] The accompanying drawings are:

[0109] 10. Clamping device; 20. Clamping space.

[0110] 100. Clamping arm; 110. Clamping portion; 110-1. First clamping portion; 110-2. Second clamping portion; 111. First connecting structure; 112. Interlocking structure; 113. Connecting groove; 114. Guide groove; 115. First locking groove; 116. Actuating slope; 117. Fixing ring; 120. Extension portion; 121. Trigger portion; 122. Second connecting structure; 1221. Connecting recess; 123. Distal portion; 124. Middle portion; 125. Proximal portion; 126. Groove; 130. Locked portion; 131. Fixing portion; 132. Suspension structure; 133. First limiting structure; 134. Second limiting structure; 135. Actuating portion.

[0111] 200, conveying part; 210, sheath; 211, resisting structure; 211-1, first resisting structure; 211-2, second resisting structure; 2111, responding part; 212, second abutting part; 213, first pipe; 214, second pipe; 215, guide groove; 216, guide slider; 220, core shaft; 230, fixed section; 240, rotating section.

[0112] 300, operating unit; 310, fixed handle; 320, sliding handle.

[0113] 400, locking member; 410, accommodating cavity; 411, distal opening; 412, side opening; 420, first stop structure; 430, second stop structure; 440, contact portion; 450, first matching portion; 460, second matching portion; 470, main body; 471, stop structure; 472, guide pin; 473, locking protrusion; 474, limiting recess; 480, first abutting portion; 491, first half body; 492, second half body; 493, second locking groove; 494, base. DETAILED DESCRIPTION

[0114] To more clearly illustrate the technical solutions of the embodiments of this specification, the following briefly describes the drawings required for describing the embodiments. Obviously, the drawings described below are merely examples or embodiments of this specification. Those skilled in the art can apply this specification to other similar scenarios based on these drawings without inventive effort. Unless otherwise apparent from the context or otherwise noted, the same reference numerals in the figures represent the same structure or operation.

[0115] It should be understood that the terms "system," "device," "unit," and / or "module" used herein are a method for distinguishing different components, elements, parts, portions, or assemblies at different levels. However, if other terms can achieve the same purpose, the terms may be replaced by other expressions.

[0116] As used in this specification and claims, unless the context clearly indicates otherwise, the words "a," "an," "an," and / or "the" do not refer to the singular but also include the plural. Generally speaking, the terms "comprises" and "include" only indicate the inclusion of the steps and elements specifically identified, and these steps and elements do not constitute an exclusive list. A method or apparatus may also include other steps or elements.

[0117] Flowcharts are used throughout this specification to illustrate the operations performed by systems according to embodiments of this specification. It should be understood that preceding or following operations do not necessarily need to be performed in exact order. Instead, the steps may be processed in reverse order or simultaneously. Furthermore, other operations may be added to these processes, or one or more operations may be removed from these processes.

[0118] Clips are common surgical instruments used in endoscopy, primarily for hemostasis by mechanically clamping tissue wounds. Traditional clips consist of a sheath, a clamping element, and a storage tube. During surgical application, the clamping element clamps the tissue, then moves into the storage tube for locking and storage. After tissue clamping is complete, the clamping element and storage tube are released from the sheath and ultimately remain in the body to maintain wound closure.

[0119] Traditional clip instruments, due to their large gripping parts and storage tubes after release, can obstruct the surgical field of view around the wound in confined surgical spaces. This can lead to risks such as damage to surrounding tissues and low clamping accuracy due to poor visibility. This problem is particularly prominent in complex surgeries that require the continuous deployment of multiple gripping parts. The large gripping parts and storage tubes not only obstruct the surgical field of view but also increase the difficulty of operation, making the procedure more difficult.

[0120] In view of this, some embodiments of this specification provide various implementation plans of the clamp instrument. These implementation plans aim to reduce the size of the clamping part retained in the body by various means such as setting a locking piece between multiple clamping parts or reducing the length of the clamping part, thereby optimizing the surgical field of view. The operator can obtain a comprehensive and clear surgical field of view by using the improved clamp instrument, thereby avoiding risks such as damage to surrounding tissues and insufficient clamping positioning accuracy, thereby improving surgical safety. It should be noted that, under the premise of no contradiction, certain features, structures or characteristics between the various embodiments can be appropriately combined or borrowed.

[0121] FIG. 1 is an exemplary structural diagram of a clip instrument 10 according to some embodiments of the present disclosure.

[0122] As shown in FIG1 , in some embodiments, the clamp instrument 10 includes a clamp arm 100, a delivery portion 200, and an operating portion 300. The operating portion 300 is disposed at the proximal end of the delivery portion 200, and the clamp arm 100 is disposed at the distal end of the delivery portion 200. The “proximal end” and “distal end” referred to in the embodiments of this specification may indicate a direction, which refers to the side along the axial direction of the clamp instrument 10 (for example, the direction in which the sheath 210 of the delivery portion 200 extends within the endoscope channel), the side facing the operator is the “proximal end”, and the side facing the side extending into the human body for treatment is the “distal end”; “proximal end” and “distal end” may also refer to partial structures located in the corresponding directions, and should not be understood as indicating only the ends.

[0123] In some application scenarios, the delivery portion 200 has good passability. The delivery portion 200 and its distal clamping arm 100 pass through the working channel of the endoscope into the human body to approach the tissue to be clamped, where "tissue" refers to the organ tissue of the human body or other organisms. The operating portion 300 is located outside the human body or other organisms. The user controls the clamping arm 100 by manipulating the operating portion 300 to perform a surgical operation. For example, the clamping arm 100 can clamp a tissue wound to keep it closed, thereby assisting wound healing.

[0124] In some embodiments, the delivery unit 200 includes a sheath 210 and a core shaft 220. The core shaft 220 is disposed within the channel of the sheath 210 and extends axially along the sheath 210. The proximal end of the core shaft 220 is connected to the operating unit 300, and the distal end of the core shaft 220 is connected to the clamp arm 100. The terms "axial" and "radial" as used in the embodiments of this specification may refer to directions. The "radial" direction is perpendicular to the "axial" direction, or the axial direction is the direction in which the channel of the sheath 210 extends, while the radial direction is perpendicular to the direction in which the channel of the sheath 210 extends.

[0125] In some embodiments, the sheath 210 can be flexible and bendable in any direction. In some embodiments, the operating portion 300 is composed of a fixed handle 310 and a sliding handle 320. The sliding handle 320 can slide axially relative to the fixed handle 310. The distal end of the sliding handle 320 is fixedly connected to the proximal end of the core shaft 220. The user controls the sliding handle 320 to move axially along the fixed handle 310 in vitro, thereby controlling the axial movement of the core shaft 220 within the channel of the sheath 210, so that the clamp arm 100 can perform corresponding surgical operations, such as opening, closing, locking, and releasing.

[0126] FIG. 2 is an exemplary structural block diagram of a clip instrument 10 according to some embodiments of the present disclosure.

[0127] Some embodiments of the present disclosure provide a clip instrument 10 , which includes a sheath 210 , a clip arm 100 , and a locking element 400 .

[0128] In some embodiments, the sheath 210 includes a channel that is used to accommodate control structures such as the mandrel 220 and at least a portion of the clamp arm 100 (such as the extension 120 mentioned below), the locking member 400, and other structures.

[0129] In some embodiments, the clamp arm 100 includes at least two clamping portions 110. The clamping portions 110 close the wound by opening, closing, locking, and other operations, thereby achieving hemostasis and healing. For example, the clamp arm 100 includes two, three, or four clamping portions 110, with each clamping portion 110 forming a clamping space.

[0130] In some embodiments, the locking member 400 is releasably disposed within the passageway of the sheath 210. When engaged with the at least two clamping portions 110, the locking member 400 locks the at least two clamping portions 110. In some embodiments, the locking member 400 releasably engages with the sheath 210. When subjected to an external force, the locking member 400 can be released from the sheath 210 and removed from the passageway of the sheath 210. The locking member's location within the sheath isolates it from the external environment, reducing the risk of failure due to interference from external factors (e.g., blood or tissue fragments) and preventing accidental loosening of the locking member.

[0131] In some embodiments, an axially restrained fit is formed between the locking element 400 and the sheath 210, and the condition for releasing the axial restraint fit is that the force generated by the clamping portion 110 moving from the distal end to the proximal end and contacting the locking element 400 causes the locking element 400 to release from the sheath 210. The axially restrained fit between the locking element 400 and the sheath 210 ensures that the locking element 400 will not accidentally loosen or detach from the sheath before a specific release condition is met. This stability and reliability is crucial for the clamping portion 100 to clamp tissue and improve control accuracy.

[0132] In some embodiments, when the clamping portion 110 is in a locked state, the locking member 400 is located between at least two clamping portions 110. In this way, the locking member 400 does not need to occupy the space outside the clamping portion 110, thereby reducing the size of the clamping portion 110 retained in the body and optimizing the surgical field of view.

[0133] The first embodiment of this specification provides an exemplary clip instrument 10 , which will be described below with reference to FIG. 3 to FIG. 17C .

[0134] FIG3 is a block diagram illustrating an exemplary structure of a clip instrument 10 according to some embodiments of the present disclosure.

[0135] As shown in FIG. 3 , in some embodiments, the clip instrument 10 includes a sheath 210 , a clip arm 100 , and a locking member 400 .

[0136] In some embodiments, the sheath 210 includes a channel that is used to accommodate control structures such as the mandrel 220 and at least a portion of the clamp arm 100 (such as the extension 120 ), the locking member 400 , and other structures.

[0137] In some embodiments, the clamping arm 100 includes at least two clamping portions 110 and at least two extending portions 120, and the extending portions 120 are releasably connected to the clamping portions 110. In the embodiments of this specification, "releasably connected" may mean that the two components remain connected when a preset condition is met (for example, when the external force is less than a preset threshold), and release and separate from each other when the preset condition is not met (for example, when the external force is greater than a preset threshold).

[0138] In some embodiments, the clamping portion 110 includes a first clamping portion 110-1 and a second clamping portion 110-2. When the clamping portion 110 is in an open state, the distal end of the first clamping portion 110-1 and the distal end of the second clamping portion 110-2 are separated, and the extension portion 120 can also separate the proximal end of the first clamping portion 110-1 and the proximal end of the second clamping portion 110-2, thereby providing the clamping portion 110 with a sufficiently large span to clamp more tissue. When the clamping portion 110 is locked, the distal end of the first clamping portion 110-1 and the distal end of the second clamping portion 110-2 abut against each other (or abut against the clamped tissue) and close, and the proximal end of the first clamping portion 110-1 and the proximal end of the second clamping portion 110-2 also abut against each other and close. In some embodiments, after the clamping portion 110 is locked, the extension portion 120 can be released from the clamping portion 110, and the extension portion 120 and the sheath 210 can be withdrawn from the endoscope channel, while the clamping portion 110 and the locking member 400 remain inside the body. The releasable connection between the clamping portion 110 and the extension portion 120 allows the extension portion 120 and the delivery portion 200, which are not in contact with tissue, to be withdrawn outside the body, while the smaller clamping portion 110 remains inside the body. This can reduce the size of the clamping portion 110 that remains inside the body, thereby reducing the extent to which the clamping portion 110 obstructs the surgical field of view.

[0139] In some embodiments, the locking member 400 is releasably disposed within the passageway of the sheath 210. When the clamping portion 110 is in the open position, the locking member 400 is located between the at least two extensions 120. The locking member 400 is configured to engage with the at least two clamping portions 110 to lock the at least two clamping portions 110. In some embodiments, the locking member 400 is releasably engaged with the sheath 210. When subjected to an external force, the locking member 400 can be released from the sheath 210 and removed from the passageway of the sheath 210. In some embodiments, at least two passageways are formed between the outer side of the locking member 400 and the inner wall of the passageway of the sheath 210, each passageway allowing the extension 120 to pass from the passageway of the sheath 210 to the outside of the sheath 210. The locking piece 400 is arranged in the channel of the sheath tube 210, which reduces the size of the locking piece 400, and the size of the locking piece 400 after being matched with the clamping part 110 is also smaller; by providing the extension part 120 and the locking piece 400, the retention length of the locking piece 400 and the clamping part 110 can be reduced by 30% to 70% compared with the traditional clamping part 110, effectively improving the operating field of view of the operation and reducing the difficulty of the operation; in addition, the locking piece 400 is arranged on the inner side of the extension part 120, which solves the problem of the limited opening angle of the extension part 120, that is, the opening angle of the extension part 120 is not limited by the locking piece 400, so that the clamping part 110 obtains a larger clamping space 20.

[0140] FIG4 is a block diagram illustrating an exemplary structure of a clip instrument 10 according to other embodiments of the present disclosure.

[0141] As shown in FIG. 4 , in some embodiments, the clip instrument 10 includes a sheath 210 , a clip arm 100 , and a locking member 400 .

[0142] In some embodiments, the sheath 210 includes a channel. In some embodiments, the channel of the sheath 210 is used to accommodate control structures such as the core shaft 220, and to accommodate at least a portion of the clamp arm 100, the locking member 400, and other structures.

[0143] In some embodiments, the clamp arm 100 includes at least two clamping portions 110, forming a clamping space 20 between the at least two clamping portions 110. A locked portion 130 is provided on a side of the clamping portion 110 facing the clamping space 20. In some embodiments, the clamping portion 110 includes an open state and a closed state. In the open state, the at least two clamping portions 110 move away from each other, allowing tissue to enter the clamping space 20. In the closed state, the at least two clamping portions 110 move closer to each other, confining the tissue within the reduced clamping space 20, thereby closing the tissue wound.

[0144] In some embodiments, the locking member 400 is releasably disposed within the passageway of the sheath 210, and when the locking member 400 engages with the locked portion 130, at least two clamping portions 110 are locked. Because the locked portion 130 is disposed on the side of the clamping portion 110 facing the clamping space 20, the locking member 400 locks the locked portion 130 within the at least two clamping portions 110, eliminating the space outside the clamping portions 110. This makes the closed structure of the clamping portions 110 more compact and smaller, thereby minimizing the surgical field of view obstructed by the clamping portions 110.

[0145] FIG. 5 is an exemplary structural block diagram of a clip instrument 10 according to yet other embodiments of the present disclosure.

[0146] As shown in FIG. 5 , in some embodiments, the clip instrument 10 includes a sheath 210 , a clip arm 100 , and a locking member 400 .

[0147] In some embodiments, the sheath 210 includes a channel. In some embodiments, the channel of the sheath 210 is used to accommodate control structures such as the core shaft 220, and to accommodate at least a portion of the clamp arm 100, the locking member 400, and other structures.

[0148] In some embodiments, the clamp arm 100 includes at least two clamping portions 110. In some embodiments, the locking member 400 is used to lock the at least two clamping portions 110. The at least two clamping portions 110 clamp the tissue wound by opening, closing, and other operations.

[0149] In some embodiments, the sheath 210 includes a resisting structure 211, which releasably limits the locking member 400 to the channel of the sheath 210. In some embodiments, the clamping portion 110 includes an operating state and a release state, wherein the operating state includes an open state, a closed state, and a locked state. In the operating state, the locking member 400 cooperates with the resisting structure 211 and is located in the channel of the sheath 210. In the release state, the locking member 400 is released from the resisting structure 211 and is located outside the channel of the sheath 210. The operating state refers to a state in which the clamping arm 100 can be controlled by the core shaft 220, including but not limited to the open state, closed state, locked state, etc. of the clamping portion 110; the release state refers to a state in which the clamping portion 110 and the locking member 400 are separated from the sheath 210 and become independent components.

[0150] In some embodiments, the resisting structure 211 can limit the axial movement of the locking member 400 along the sheath 210. The resisting structure 211 is configured to fail the limiting movement of the locking member 400 from the proximal end to the distal end due to breakage, displacement or deformation, so that the locking member 400 can be released from the sheath 210.

[0151] By positioning the locking member 400 within the sheath 210, the locking member 400 is further miniaturized, reducing the space it occupies and minimizing obstruction to the surgical field of view. The locking member 400 engages with the sheath 210 via the retaining structure 211. During the opening or closing operation of the clamping portion 110, there is no contact between the clamping portion 110 and the locking member 400. Movement of the clamping portion 110 or other components (such as the extension portion 120) does not affect the connection stability of the locking member 400.

[0152] The following describes in detail some exemplary structures of the clip device 10 according to Example 1. It should be noted that, under the guidance of this specification, those skilled in the art may combine and modify the features of the various embodiments described below and above in various ways, and such combinations and modifications remain within the scope of this specification. Furthermore, the embodiments described below are for illustrative purposes only and do not limit the scope of application of this specification.

[0153] Fig. 6 is an exploded view of the clamp arm 100 and the delivery portion 200 according to some embodiments of the present disclosure. Fig. 7 is a partial cross-sectional view of the clamp arm 100 and the delivery portion 200 according to some embodiments of the present disclosure.

[0154] As shown in Figures 6 and 7, the clamp arm 100 includes a sheath 210, at least two clamping portions 110, at least two extensions 120, and a locking member 400. In some embodiments, the locking member 400 is releasably disposed within the passageway of the sheath 210. In some embodiments, the clamping portions 110 and the extensions 120 are releasably connected. In some embodiments, the clamping portions 110 and the extensions 120 are integrally formed.

[0155] In some embodiments, the clamping portion 110 is in an open state, the clamping portion 110 is connected to the extension portion 120, and at least two clamping portions 110 are spaced apart from each other. The distal end of the extension portion 120 extends outside the passageway of the sheath tube 210. A predetermined distance is maintained between the proximal end of the clamping portion 110 and the distal end of the sheath tube 210, and the clamping portion 110 is located outside the passageway of the sheath tube 210. The locking member 400 is axially limited and disposed within the passageway of the sheath tube 210. The locking member 400 is located between the at least two extension portions 120, and the locking member 400 and the sheath tube 210 are releasably engaged via the retaining structure 211.

[0156] In some embodiments, the clamping portion 110 is in a closed state, connected to the extension portion 120, with at least two clamping portions 110 close to each other and in contact with the locking member 400, and the distal end of the locking member 400 located between the clamping portions 110. The extension portion 120 is retracted into the passageway of the sheath 210, while at least two clamping portions 110 remain outside the passageway of the sheath 210. During the operation of the clamping portion 110 to clamp tissue, the clamping portion 110 remains outside the passageway of the sheath 210, preventing the distal end of the sheath 210 from contacting the tissue, thereby improving the stability of the tissue clamping within the clamping space 20.

[0157] In some embodiments, the clamping portions 110 are in a locked state, with at least two clamping portions 110 locked with the locking element 400. For example, the proximal ends of the clamping portions 110 or the locked portions 130 form a limited fit with the locking element 400, and the at least two clamping portions 110 are locked, with the proximal ends of the at least two clamping portions 110 located within the passage of the sheath 210. After the at least two clamping portions 110 are closed, the locking element 400 is disengaged from the sheath 210, and the locking element 400 can be removed from the sheath 210 from the distal end. In some embodiments, when the clamping portions 110 are in a locked state, the locking element 400 is located between the at least two clamping portions 110, so that the locking element 400 does not need to occupy space outside the clamping portions 110, thereby reducing the obstruction of the surgical field by the clamping portions 110.

[0158] In some embodiments, the clamping portion 110 includes a pre-release state, which is executed before, simultaneously with, or after the locking state. The pre-release state includes: the clamping portion 110 and the extension portion 120 are connected, the locking member 400 is disengaged from the sheath tube 210, the locking member 400 is released from the sheath tube 210, the clamping portion 110 and the extension portion 120 remain connected, and the clamping portion 110 and the locking member 400 are still located in the channel of the sheath tube 210.

[0159] In some embodiments, the clamping portion 110 is in a released state, the locking member 400 and the sheath 210 are released, and after the locking member 400 locks at least two clamping portions 110, the clamping portion 110 and the extension portion 120 are released, and the entirety is released from the distal end of the sheath 210 and is located outside the channel of the sheath 210 and remains at the tissue wound, and the sheath 210 and other components are withdrawn from the human body.

[0160] In some embodiments, the extension portion 120 can be in an extended state and a retracted state. For example, in the extended state, the distal end of the extension portion 120 extends beyond the passageway of the sheath tube 210, maintaining a predetermined distance between the proximal end of the clamping portion 110 and the distal end of the sheath tube 210. This predetermined distance can be determined based on the size of the surrounding space, the structural characteristics of the extension portion 120, and other factors. When the extension portion 120 extends beyond the passageway of the sheath tube 210, the predetermined distance between the proximal end of the clamping portion 110 and the distal end of the sheath tube 210 is maintained, thereby optimizing the clamping space 20, for example, by providing a larger opening span for the clamping portion 110.

[0161] In some embodiments, in the retracted state, the extension portion 120 is received within the channel of the sheath 210 and closes at least two clamping portions 110. For example, the extension portion 120 moves from the distal end to the proximal end, and the sheath 210 squeezes the extension portion 120 to bring the clamping portions 110 closer to each other until the clamping portions 110 are closed.

[0162] In some embodiments, the sheath 210 includes a fixed section 230 and a rotating section 240, the proximal end of the rotating section 240 is rotatably connected to the distal end of the fixed section 230, and the rotating section 240 is configured to rotate around the axis of the sheath 210. In some embodiments, one of the rotating section 240 and the fixed section 230 is provided with an annular groove, and the other is provided with a slider, and the slider and the annular groove are rotatably matched. For example, the slider includes an annular slider, and the annular slider and the annular groove are slidably matched to enable the rotating section 240 to rotate relative to the fixed section 230. In other examples, the slider includes a dot-shaped protrusion that can slide along the annular groove. In some embodiments, the annular groove extends along the circumferential direction of the sheath 210, and the annular slider is embedded in the annular groove to limit the axial displacement of the rotating section 240 and the fixed section 230 relative to the sheath 210. In some embodiments, the operating unit 300 controls the rotation of the mandrel 220, which transmits torque to the clamp arm 100, which in turn transmits torque to the rotating section 240. The rotation of the mandrel 220 drives the clamp arm 100 and the rotating section 240 to rotate simultaneously relative to the fixed section 230. By providing the rotating section 240, the clamp arm 100 can rotate about the axis of the sheath 210, making it easier to adjust the closing direction of the at least two clamping parts 110 to be consistent with the closing direction of the tissue wound, thereby improving the accuracy of clamping the tissue wound.

[0163] In some other embodiments, the sheath tube 210 is an integrally formed structure, which facilitates processing and saves costs.

[0164] Figure 8 is an exemplary structural diagram of the clamping portion 110 shown in some embodiments of the present specification. Figure 9 is an exemplary side view of the clamping portion 110 shown in some embodiments of the present specification. Figure 10 is an exemplary structural diagram of the clamping portion 110 shown in other embodiments of the present specification. Figure 11 is an exemplary structural diagram of the locking member 400 shown in some embodiments of the present specification. Figure 12 is a partial cross-sectional view of the locking member 400 shown in some embodiments of the present specification. Figure 13 is an exemplary structural diagram of the locking member 400 locked to the clamping portion 110 shown in some embodiments of the present specification. Figure 14 is a cross-sectional view of the locking member 400 locked to the clamping portion 110 shown in some embodiments of the present specification.

[0165] As shown in Figures 8 to 14, in some embodiments, the clamping portion 110 includes a locked portion 130, and the locking member 400 is configured to cooperate with the locked portion 130. In some embodiments, the locking member 400 includes a receiving cavity 410, which is configured to accommodate at least two locked portions 130 of the clamping portion 110, thereby maintaining the locked portions 130 of the at least two clamping portions 110 in a closed state. In some embodiments, the receiving cavity 410 is located at the distal end of the locking member 400 and has a distal opening 411. When the locked portion 130 moves from the distal end to the proximal end, it enters the receiving cavity 410 through the distal opening 411.

[0166] In some embodiments, the locked portion 130 includes at least one limiting structure, and the locking member 400 includes at least one stopping structure. When the limiting structure and the stopping structure cooperate, the relative movement between the clamping portion 110 and the locking member 400 is restricted. For example, there is one limiting structure and one stopping structure. When the limiting structure and the stopping structure cooperate, the relative movement between the clamping portion 110 and the locking member 400 in all directions is restricted. For example, there are multiple limiting structures and multiple stopping structures. The cooperation of any one set of limiting structures and the stopping structure can restrict the movement of the clamping portion 110 and the locking member 400 in at least one direction, and the combination of all limiting structures and the stopping structures can fully restrict the movement of the clamping portion 110 and the locking member 400 in all directions. The cooperation between the limiting structure and the stopping structure can improve the locking stability between the clamping portion 110 and the locking member 400.

[0167] In some embodiments, the locked portion 130 includes a first limiting structure 133, and the locking member 400 includes a first stopping structure 420. The first limiting structure 133 cooperates with the first stopping structure 420 to limit relative movement between the clamping portion 110 and the locking member 400 in a first direction. The first direction includes the direction indicated by arrow D1 in FIG. 13 , such as the width direction of the clamping portion 110. By limiting relative movement between the clamping portion 110 and the locking member 400 in the first direction, at least the two clamping portions 110 can remain relatively stationary in at least the first direction, preventing the at least two clamping portions 110 from lateral or rotational movement relative to each other.

[0168] In some embodiments, the first limiting structure 133 includes a limiting pin, and the first stopping structure 420 includes a stopping groove, with the limiting pin configured to cooperate with the stopping groove. In some embodiments, the limiting pin is provided protruding from the proximal end of the locked portion 130. For example, the limiting pin protrudes from the proximal end of the hanging portion 132 mentioned below, and the stopping groove is recessed from the bottom wall of the proximal end of the accommodating cavity 410. After the limiting pin is inserted into the stopping groove, the stopping groove can limit the circumferential position of the limiting pin.

[0169] In some embodiments, the locked portion 130 includes a second limiting structure 134, and the locking member 400 includes a second stopping structure 430. The second limiting structure 134 cooperates with the second stopping structure 430 to limit relative movement between the clamping portion 110 and the locking member 400 in a second direction. The second direction is non-parallel to the first direction. For example, the second direction includes the direction indicated by arrow D2 in FIG. 13 , such as the longitudinal direction of the clamping portion 110. By limiting relative movement between the clamping portion 110 and the locking member 400 in the second direction, at least the two clamping portions 110 can remain relatively stationary in at least the second direction, preventing the at least two clamping portions 110 from axial relative movement or rotation. The locking member 400 locks the clamping portion 110 in multiple directions through multiple stopping structures, thereby improving the stability of the clamping portion 110 in clamping tissue.

[0170] In some embodiments, the second retaining structure 134 includes a locking spring, and the second stop structure 430 includes at least two locking recesses. The locking spring is configured to spring into the locking recess when aligned with the locking recess. In some embodiments, the locking spring is disposed on the overhang portion 132, with the proximal end of the locking spring connected to the overhang portion 132 and the distal end including a bent portion that bends from the overhang portion 132 toward the clamping portion 110. The locking recess is disposed on the sidewall of the accommodating cavity 410. When the locking spring moves from the distal end to the proximal end, the bent portion of the locking spring spring springs into the locking recess to form a retaining position.

[0171] In some embodiments, the locking member 400 includes a third stop structure, and the accommodating cavity 410 of the locking member 400 constitutes the third stop structure; the locked portion 130 includes a third limiting structure, and the third limiting structure is arranged on the side of the clamping portion 110 facing the clamping space 20; when the clamping portion 110 is in a closed state, the third limiting structure is located in the accommodating cavity 410, and the movement of at least two clamping portions 110 in the direction of moving away from each other and / or in the direction of relative rotation is restricted.

[0172] In some embodiments, the locked portion 130 includes a fixed portion 131 and a suspended portion 132. The fixed portion 131 is connected to the side edge of the clamping portion 110. The suspended portion 132 is connected to the fixed portion and is arranged with a gap between it and the inner surface of the clamping portion 110. When the clamping arm 100 is locked, the suspended portion 132 is located within the accommodating cavity 410, forming a third limiting structure. The other side is connected to the suspended portion 132, so that the suspended portion 132 maintains a gap with the clamping portion 110. In some embodiments, the accommodating cavity 410 of the locking member 400 has side openings 412 on both sides. When the locked part 130 cooperates with the locking member 400, the side openings 412 of the accommodating cavity 410 avoid the fixing part 131, so that the suspended part 132 of the locked part 130 can be located in the accommodating cavity 410, and the distal part of the locking member 400 is located in the gap between the suspended part 132 and the clamping part 110. In this way, the locking member 400 can lock the locked part 130 between at least two clamping parts 110 without occupying the outer space of the clamping part 110.

[0173] In some embodiments, the accommodating cavity 410 of the locking member 400 is configured so that the suspended portions 132 of the locked portions 130 of at least two clamping portions 110 can remain in a mutually fitted state, so that at least two clamping portions 110 maintain a stable locked state and reduce the size of the clamping portion 110 after locking.

[0174] In some embodiments, locking member 400 includes a contact portion 440 located distally of second stop structure 430, for example, at the distal end of locking member 400. Contact portion 440 is configured to provide feedback resistance to prompt an operator to enter a locked state. In some embodiments, the distal end surface of locking member 400 is configured as contact portion 440.

[0175] In some embodiments, the clamping portion 110 includes a pre-locking state and a final locking state.

[0176] In the pre-locked state, the locked portion 130 abuts the contact portion 440 of the locking member 400. For example, the second limiting structure 134 of the locked portion 130 abuts the contact portion 440 of the locking member 400, generating feedback resistance that prevents the clamping portion 110 from moving from the distal end to the proximal end. In some embodiments, the second limiting structure 134 includes a locking spring. Before entering the accommodating cavity 410, the distal bent portion of the locking spring abuts the contact portion 440 of the locking member 400. The contact portion 440 then generates feedback resistance against the locking spring. This feedback resistance is fed back to the operator via the core shaft 220, prompting the operator that the clamping portion 110 is about to enter the locked state. In some embodiments, after the operator feels the feedback resistance, they can reconfirm the clamping status of the clamping portion 110 on the tissue. If the clamping portion 110 does not clamp the tissue normally, the operator pushes the core shaft 220 from the proximal end to the distal end, causing the clamping portion 110 to turn from a closed state to an open state and re-clamp the tissue. If the clamping portion 110 clamps the tissue normally, the operator pulls the core shaft 220 from the distal end to the proximal end, causing the locking spring to deform under force, and the bent portion passes over the contact portion 440 and enters the accommodating cavity 410 to mate with the locking recess, and the clamping portion 110 enters the final locked state. By providing the contact portion 440 and the second stop structure 430 to form feedback resistance, the operator can be prompted to confirm the tissue clamping status before locking, thereby reducing surgical errors.

[0177] In the final locking state, the second limiting structure 134 goes over the contact portion 440 and cooperates with the second stopping structure 430 , and the first limiting structure 133 cooperates with the first stopping structure 420 , and at least two clamping portions 110 are locked.

[0178] Figure 15 is an exemplary structural diagram of the distal end of the sheath tube 210 according to some embodiments of the present specification. Figure 16 is an exemplary structural diagram of the locking member 400 mated with the sheath tube 210 according to some embodiments of the present specification. Figure 17 is a cross-sectional view of the locking member 400 mated with the sheath tube 210 according to some embodiments of the present specification.

[0179] As shown in Figures 11, 12, and 15 to 17, in some embodiments, the sheath 210 and the rotating section 240 of the sheath 210 are integrally formed to simplify processing. Alternatively, the sheath 210 and the rotating section 240 of the sheath 210 are separate structures. In some embodiments, the sheath 210 or the rotating section 240 of the sheath 210 includes at least one retaining structure 211, which is used to retain the locking member 400 within the passage of the sheath 210. In some embodiments, the retaining structure 211 protrudes radially inward from the inner wall of the sheath 210. When the retaining structure 211 is releasably engaged with the locking member 400, the axial movement and / or rotation of the locking member 400 relative to the sheath 210 are restricted, preventing the locking member 400 from accidentally falling out of the passage of the sheath 210.

[0180] In some embodiments, the sheath 210 includes a first retaining structure 211-1, and the locking member 400 includes a first mating portion 450. The first retaining structure 211-1 cooperates with the first mating portion 450 to limit the movement of the locking member 400 from the distal end to the proximal end relative to the sheath 210, so that the locking member 400 can be maintained in the desired position, such as the distal end of the sheath 210.

[0181] In some embodiments, the first retaining structure 211-1 includes a radially inwardly projecting stop step. The proximal surface of the locking member 400 forms a first mating portion 450, which abuts against the stop step. In some embodiments, the stop step includes, but is not limited to, at least two protrusions, a stop rod arranged radially along the sheath 210, and the like.

[0182] In some embodiments, the sheath 210 includes a second retaining structure 211-2, and the locking member 400 includes a second mating portion 460. When the second retaining structure 211-2 and the second mating portion 460 are releasably connected, the movement of the locking member 400 from the proximal end to the distal end relative to the sheath 210 is restricted. After the locking member 400 locks at least two clamping portions 110, the second retaining structure 211-2 separates from the second mating portion 460, and the locking member 400 is released from the sheath 210.

[0183] In some embodiments, the second retaining structure 211-2 includes a retaining spring, the distal end of which is connected to the inner wall of the sheath 210, and the proximal end of which protrudes radially inward from the inner wall of the sheath 210. The locking member 400 includes a retaining surface facing the distal end, which is used to cooperate with the retaining spring. In some embodiments, the retaining surface of the locking member 400 includes the bottom surface of the accommodating cavity 410, and the retaining spring is arranged corresponding to the side opening 412 of the accommodating cavity 410 of the locking member 400, so that the retaining spring can cooperate with the bottom surface of the accommodating cavity 410. In some embodiments, the retaining surface of the locking member 400 includes the surface of the distal end of the locking member 400.

[0184] As shown in conjunction with Figures 8 and 9 , in some embodiments, the clamp arm 100 includes an actuator 135. The actuator 135 is configured to move from a distal end to a proximal end. When the actuator 135 applies a force greater than or equal to a second predetermined force value to the second retaining structure 211-2, it can actuate the release of the second retaining structure 211-2 from the second mating portion 460, thereby releasing the locking element 400 from the sheath 210. The actuator 135 refers to a component or portion that can directly or indirectly cause the release of the second retaining structure 211-2 from the second mating portion 460. Providing the actuator 135 to actuate the release of the locking element 400 from the sheath 210 prevents other components or portions from disturbing the locking element 400 during movement, reducing the risk of accidental release of the locking element 400. In some embodiments, when the second retaining structure 211-2 is subjected to a force greater than or equal to the second predetermined force value, it can deform, displace, or break, releasing it from the second mating portion 460.

[0185] In some embodiments, the actuating portion 135 is disposed on the locked portion 130. For example, the actuating portion 135 is disposed on the overhanging portion 132 of the locked portion 130. The actuating portion 135 includes an edge portion on at least one side of the overhanging portion 132. In some embodiments, one side edge of the overhanging portion 132 constitutes the actuating portion 135. In some embodiments, both side edges of the overhanging portion 132 constitute the actuating portion 135.

[0186] In some embodiments, as the locked portion 130 of the clamping portion 110 enters the locking member 400, the actuating portion 135 pushes the limiting spring piece from the distal end to the proximal end, causing the limiting spring piece to deform, displace, or break and release from the limiting surface, thereby releasing the locking member 400 from the sheath 210. In some embodiments, after the proximal end of the limiting spring piece engages with the limiting surface, and the suspended portion 132 of the locking member 400 enters the accommodating cavity 410, the actuating portion 135 pushes the limiting spring piece to deform or displace radially outward relative to the sheath 210, thereby releasing the limiting spring piece from the limiting surface.

[0187] In some embodiments, after the proximal end of the limiting spring piece cooperates with the limiting surface, in the radial direction of the sheath 210, the distance between the first limiting structure 133 and the actuating portion 135 is greater than the distance from the first stop structure 420 to the limiting spring piece. After the actuating portion 135 enters the locking member 400, it can push the limiting spring piece radially outward along the sheath 210, so that the limiting spring piece is detached from the limiting surface.

[0188] In some embodiments, the first limiting structure 133 of the clamping portion 110 cooperates with the first stop structure 420, and after the second limiting structure 134 cooperates with the second stop structure 430, the clamping portion 110 is locked with the locking member 400; after the locking is completed, the actuating portion 135 of the clamping portion 110 pushes the limiting spring to release from the limiting surface, and the locking member 400 is released from the sheath 210.

[0189] In some embodiments, the first limiting structure 133 cooperates with the first stop structure 420, and the second limiting structure 134 cooperates with the second stop structure 430. At the same time, the actuator 135 pushes the limiting spring to release from the limiting surface, and the locking member 400 is locked with the clamping portion 110 and released from the sheath 210 at the same time.

[0190] In some embodiments, the actuating portion 135 pushes the limiting spring to release from the limiting surface. After the release is completed, the first limiting structure 133 cooperates with the first stop structure 420, the second limiting structure 134 cooperates with the second stop structure 430, and the clamping portion 110 is locked with the locking member 400.

[0191] Figures 18 to 21 are exemplary structural diagrams of the locking process of the clamping portion 110 according to some embodiments of this specification. In the following example, locking and releasing of the locking member 400 are performed simultaneously. The following process can also be referred to when the two processes are not performed simultaneously.

[0192] In some embodiments, the second resisting structure 211 - 2 of the sheath tube 210 includes a limiting spring piece, which is constructed in a straight line and extends obliquely inward from the distal end to the proximal end of the sheath tube 210 .

[0193] As shown in Figures 18 and 19, the clamp arm 100 is in a pre-locked state. The second limiting structure 134 of the locked portion 130 abuts the contact portion 440 of the locking member 400, and the locking member 400 generates feedback resistance against the clamping portion 110. The actuating portion 135 of the clamping portion 110 has not yet contacted the second resisting structure 211-2 of the sheath tube 210. The proximal end of the second resisting structure 211-2 forms a limiting engagement with the second mating portion 460 of the locking member 400.

[0194] As shown in Figures 20 and 21, the clamping portion 110 moves from the distal end to the proximal end, and the clamping arm 100 switches from the pre-locked state to the locked state. The first limiting structure 133 of the locked portion 130 cooperates with the first stop structure 420 of the locking member 400, and the second limiting structure 134 of the locked portion 130 cooperates with the second stop structure 430 of the locking member 400. At the same time, the actuating portion 135 of the clamping portion 110 moves to the proximal end of the second resisting structure 211-2 of the sheath tube 210 and expands the proximal end of the second resisting structure 211-2 until it releases from the second engaging portion 460 of the locking member 400, thereby releasing the locking member 400 from the sheath tube 210.

[0195] Figure 22 is an exemplary structural diagram of the distal end of a sheath tube 210 according to other embodiments of the present specification. Figure 23 is an exemplary structural diagram of a locking member 400 mated with a sheath tube 210 according to other embodiments of the present specification. Figure 24 is a cross-sectional view of a locking member 400 mated with a sheath tube 210 according to other embodiments of the present specification.

[0196] As shown in Figures 22 to 24, in some embodiments, the second retaining structure 211-2 of the sheath tube 210 includes a limiting spring piece, which is configured as a broken line. The broken line limiting spring piece includes an inclined section and a straight section. The proximal end of the inclined section is connected to the distal end of the straight section. The straight section is parallel or substantially parallel to the axis of the sheath tube 210, and the inclined section is not parallel to the axis of the sheath tube 210. The connection between the inclined section and the straight section is configured as a bending point. The proximal end of the straight section is used to cooperate with the second mating portion 460 of the locking member 400. This design can adjust the order in which the locking member 400 locks the clamping portion 110 and releases the locking member 400 from the sheath tube 210. For details, see the locking process of Figures 25 to 27.

[0197] Figures 25 to 27 are exemplary structural diagrams of the locking process of the clamping portion 110 according to other embodiments of the present disclosure. In this process, the locking member 400 and the sheath tube 210 are first released, and after the release is completed, the clamping portion 110 and the locking member 400 are locked.

[0198] As shown in Figure 25, the clamp arm 100 is in a pre-locking state, the second limiting structure 134 of the locked part 130 abuts against the contact part 440, the actuating part 135 of the clamping part 110 moves to the distal end of the second supporting structure 211-2 of the sheath 210, and the proximal end of the second supporting structure 211-2 cooperates with the second matching part 460 of the locking member 400.

[0199] As shown in Figure 26, the clamping portion 110 moves from the distal end to the proximal end, releasing the locking member 400 from the sheath 210. After the actuator 135 moves from the distal end to the proximal end, it compresses the bending point of the second resisting structure 211-2, causing the straight section of the second resisting structure 211-2 to deform or displace radially outwardly along the sheath 210. The proximal end of the second resisting structure 211-2 releases from the second mating portion 460 of the locking member 400, releasing the locking member 400 from the sheath 210. At this point, the first limiting structure 133 of the locked portion 130 has not yet engaged with the first stop structure 420 of the locking member 400, and the second limiting structure 134 of the locked portion 130 has not yet engaged with the second stop structure 430 of the locking member 400.

[0200] As shown in Figure 27, after the locking member 400 and the sheath 210 are released, the clamping part 110 continues to move from the distal end to the proximal end, and the clamping arm 100 switches from the pre-locking state to the locking state. The first limiting structure 133 of the locked part 130 cooperates with the first stop structure 420 of the locking member 400, and the second limiting structure 134 of the locked part 130 cooperates with the second stop structure 430 of the locking member 400, and the clamping part 110 is locked with the locking member 400.

[0201] In some embodiments, the locking member 400 is first locked with the clamping portion 110 and then released from the sheath tube 210. In some embodiments, the second mating portion 460 of the locking member 400 includes a limiting recess (not shown), which is provided on the side of the locking member 400 facing the extension portion 120. The second retaining structure 211-2 of the sheath tube 210 includes an elastic pin, which is provided on the side wall of the sheath tube 210 near the extension portion 120. An axially extending avoidance groove is formed on the extension portion 120, which is used to avoid the elastic pin. The elastic pin passes through the avoidance groove of the extension portion 120 and cooperates with the limiting recess of the locking member 400, so that the locking member 400 can be releasably connected to the sheath tube 210. After the locking piece 400 is locked with the clamping part 110, the extension part 120 continues to move from the distal end to the proximal end, so that the end of the avoidance groove of the extension part 120 actuates the elastic pin, and the elastic pin is deformed, displaced or broken and released from the limiting recess. At this time, the locking piece 400 is released from the sheath tube 210.

[0202] Figure 28 is an exemplary structural diagram of an extension portion 120 according to some embodiments of the present specification. Figure 29 is an isometric view of the clamping portion 110 and the extension portion 120 in cooperation with each other according to some embodiments of the present specification. Figure 30 is a front view of the clamping portion 110 and the extension portion 120 in cooperation with each other according to some embodiments of the present specification, wherein the locked portion 130 is hidden. Figure 31 is a side view of the clamping portion 110 and the extension portion 120 in cooperation with each other according to some embodiments of the present specification.

[0203] As shown in Figures 28 to 31 , in some embodiments, the extension portion 120 or the clamping portion 110 includes a trigger portion 121. The trigger portion 121 is configured to trigger the extension portion 120 and the clamping portion 110 to release when subjected to a force in a first direction greater than or equal to a first predetermined force value. The first direction is non-parallel to the direction of movement of the extension portion 120, and the first direction is the direction indicated by arrow D1 in Figure 28 . In some embodiments, the first direction may include the width direction of the clamping portion 110. In other embodiments, the first direction may also include other directions at an angle to the width direction of the clamping portion 110. In the process of the extension portion 120 driving the clamping portion 110 to move from the distal end to the proximal end, when the clamping portion 110 is locked and the locking member 400 is released from the sheath 210, a pulling force along the movement direction of the extension portion 120 will be generated between the extension portion 120 and the clamping portion 110. By setting the trigger portion 121, the extension portion 120 can be released from the clamping portion 110 only under specific trigger conditions, which can avoid accidental detachment of the extension portion 120 and the clamping portion 110 due to the pulling force along the movement direction between the extension portion 120 and the clamping portion 110, thereby reducing the surgical risk.

[0204] In some embodiments, the clamping portion 110 includes a first connecting structure 111, and the extension portion 120 includes a second connecting structure 122. The first connecting structure 111 and the second connecting structure 122 are releasably connected. A clamping space 20 is formed between at least two clamping portions 110. The first connecting structure 111 is provided on the side of the clamping portion 110 facing the clamping space 20, and the distal end of the extension portion 120 includes a second connecting structure 122. The first connecting structure 111 and the second connecting structure 122 are releasably connected. In some embodiments, the first connecting structure 111 includes, but is not limited to, a slot, a stopper, or a buckle protruding from the clamping portion 110 into the clamping space 20; the second connecting structure 122 includes, but is not limited to, a hook, an elastic stopper arm, or other structures. In some embodiments, the first connecting structure 111 is provided in the gap between the overhanging portion 132 of the locked portion 130 and the inner surface of the clamping portion 110, making the clamping portion 110 more compact and facilitating miniaturization of the clamping portion 110.

[0205] In some embodiments, the trigger portion 121 is configured to trigger one of the first connection structure 111 and the second connection structure 122 to break, deform, or displace and release from the other when a force in a first direction is greater than or equal to a first preset force value.

[0206] In some embodiments, the second connecting structure 122 includes two elastic arms, each of which includes a distal portion 123, a middle portion 124, and a proximal portion 125. The middle portion 124 of the elastic arm is configured as a groove 126. The first connecting structure 111 includes a buckle, which is configured as a U-shaped structure protruding toward the clamping space 20. The two elastic arms pass through the buckle, allowing the buckle to fit within the groove 126 of the middle portion 124. The distal portion 123 and the proximal portion 125 respectively limit the buckle, thereby connecting the clamping portion 110 to the extension portion 120.

[0207] In some embodiments, the inner side surface of the distal end of the groove 126 is in contact with the distal surface of the buckle, and both the inner side surface of the distal end of the groove 126 and the distal surface of the buckle are perpendicular to the axial direction of the extension 120. The axial direction of the extension 120 can be the direction indicated by arrow D2 in Figure 30. When the extension 120 moves from the distal end to the proximal end, the inner side surface of the distal end of the groove 126 and the distal surface of the buckle form a stop, which keeps the clamping portion 110 and the extension 120 connected, preventing the clamping portion 110 and the extension 120 from pulling against each other due to axial force and causing accidental separation.

[0208] In some embodiments, the inner side surface of the proximal end of the groove 126 is in contact with the proximal surface of the buckle, and both the inner side surface of the proximal end of the groove 126 and the proximal surface of the buckle are perpendicular to the axial direction of the extension 120. The axial direction of the extension 120 can be the direction indicated by arrow D2 in Figure 30. When the extension 120 moves from the proximal end to the distal end, the inner side surface of the proximal end of the groove 126 and the proximal surface of the buckle form a stop, so that the clamping portion 110 and the extension 120 remain connected, preventing the clamping portion 110 and the extension 120 from accidentally separating due to the pulling of the clamping portion 110 and the extension 120 due to axial force.

[0209] In some embodiments, the trigger portion 121 is disposed on the first connecting structure 111 or the second connecting structure 122, and the distal end of the sheath 210 includes an abutment portion 212. When the trigger portion 121 contacts the abutment portion 212, and the force exerted by the abutment portion 212 on the trigger portion 121 reaches the first predetermined force value, one of the first connecting structure 111 and the second connecting structure 122 breaks, deforms, or displaces, releasing the other. In some embodiments, the trigger portion 121 includes an inclined surface disposed at the proximal end of the elastic support arm. The inclined surface is configured such that, upon abutting the abutment portion 212, the force applied by the abutment portion 212 to the inclined surface causes the two elastic support arms to deform and move closer together, causing the buckle to disengage from the groove 126 of the elastic support arm, thereby releasing the extension portion 120 from the clamping portion 110. In some embodiments, the abutment portion 212 includes, but is not limited to, an end surface at the distal end of the sheath 210 or a protrusion disposed at the distal end of the sheath 210.

[0210] The second embodiment of this specification provides an exemplary clip device 10, which will be described below. Hereinafter, only the portions of the clip device 10 of the second embodiment that differ from the clip device 10 of the first embodiment will be described, and the remaining portions not mentioned refer to the exemplary embodiment of the clip device 10 of the first embodiment.

[0211] Figure 32 is an exemplary structural diagram of the first tubular member 213 of the sheath tube 210 according to some embodiments of the present specification. Figure 33 is an exemplary structural diagram of the second tubular member 214 of the sheath tube 210 according to some embodiments of the present specification. Figure 34 is an exemplary structural diagram of the first tubular member 213, the second tubular member 214, and the locking member 400 according to some embodiments of the present specification.

[0212] As shown in Figures 32 to 34, in some embodiments, the sheath tube 210 or the rotating section 240 of the sheath tube 210 is a split-molded structure. In some embodiments, the sheath tube 210 includes at least one retaining structure 211 for retaining the locking member 400 within the sheath tube 210 channel.

[0213] In some embodiments, the sheath 210 includes a first tubular member 213 and a second tubular member 214, wherein the first tubular member 213 can axially move with the second tubular member 214. In some embodiments, one of the first tubular member 213 and the second tubular member 214 includes a guide groove 215 extending along the axial direction, and the other includes a guide slider 216. The guide slider 216 slidably engages with the guide groove 215 to limit the circumferential displacement between the first tubular member 213 and the second tubular member 214, thereby preventing the first tubular member 213 and the second tubular member 214 from rotating relative to each other and affecting their internal structures. In addition, the guide groove 215 limits the travel range of the guide slider 216, that is, the axial movement range of the first tubular member 213 and the second tubular member 214 is limited to a reasonable range, thereby preventing the first tubular member 213 and the second tubular member 214 from separating from each other.

[0214] In some embodiments, the first tubular member 213 is disposed proximal to the second tubular member 214, and the outer diameter of the first tubular member 213 is equal to the inner diameter of the second tubular member 214, so that the second tubular member 214 is sleeved outside the first tubular member 213. When the second tubular member 214 moves axially relative to the first tubular member 213, the second tubular member 214 does not interfere with components within the first tubular member 213 (such as the locking member 400 and the extension 120). In some embodiments, the first tubular member 213 and the second tubular member 214 are maintained relative to each other by static friction. When the axial external force applied thereto is greater than the static friction, the first tubular member 213 and the second tubular member 214 undergo relative displacement.

[0215] As shown in Figures 11 and 12, in some embodiments, the sheath 210 includes a first resisting structure 211-1, and the locking member 400 includes a first mating portion 450. The first resisting structure 211-1 cooperates with the first mating portion 450 to limit the movement of the locking member 400 from the distal end to the proximal end relative to the sheath 210, so that the locking member 400 can be maintained in the desired position, such as the distal end of the sheath 210.

[0216] In some embodiments, the first retaining structure 211-1 is disposed on the inner side of the first tubular member 213. The first retaining structure 211-1 includes a radially inwardly projecting stop step. The proximal surface of the locking member 400 forms a first mating portion 450, which abuts against the stop step. In some embodiments, the stop step includes, but is not limited to, at least two protrusions, a stopper arranged radially along the sheath 210, and the like.

[0217] In some embodiments, the sheath 210 includes a second resisting structure 211-2, and the locking member 400 includes a second mating portion 460. The second resisting structure 211-2 and the second mating portion 460 are releasably connected to limit the movement of the locking member 400 from the proximal end to the distal end relative to the sheath 210, so that the locking member 400 can be released from the sheath 210 after locking at least two clamping portions 110.

[0218] In some embodiments, the second retaining structure 211-2 is disposed on the second tube 214. In some embodiments, the second retaining structure 211-2 includes a stopper, the proximal end of which is connected to the second tube 214, and the distal end of which protrudes radially inward from the inner wall of the second tube 214. The second mating portion 460 of the locking member 400 includes a distally facing stopper surface configured to engage with the stopper.

[0219] In some embodiments, when the actuator 135 actuates the second tube 214 to move from the distal end to the proximal end relative to the first tube 213, and the force exerted by the actuator 135 on the second resisting structure 211-2 is greater than or equal to a second predetermined force value, the second resisting structure 211-2 deforms, displaces, or breaks, and is released from the second mating portion 460. In some embodiments, the actuator 135 comprises a proximal surface of the clamping portion 110 (see FIG. 10 ). When the extension 120 drives the clamping portion 110 to move from the distal end to the proximal end, the proximal end of the clamping portion 110 abuts against the distal surface of the second tube 214, pushing the second tube 214 from the distal end to the proximal end relative to the first tube 213. The limiting piece tends to move proximally relative to the locking member 400, causing the limiting piece to deform, displace, or break under the force, and be released from the limiting surface of the locking member 400. At this time, the locking member 400 is released from the sheath 210.

[0220] In some embodiments, the distance between the second retaining structure 211-2 and the distal end of the second tube 214 is configured such that the locking member 400 is locked to the clamping portion 110 while the locking member 400 is released from the second tube 214. For example, when the second tube 214 is connected to the locking member 400, the distal end of the locking member 400 can be exposed at the distal end of the second tube 214. When the locked part 130 contacts the locking piece 400, the actuating part 135 of the clamping part 110 contacts the distal end of the second tube 214. When the clamping part 110 continues to move from the distal end to the proximal end, the first limiting structure 133 of the locked part 130 cooperates with the first stop structure 420 of the locking piece 400, and the second limiting structure 134 of the locked part 130 cooperates with the second stop structure 430 of the locking piece 400. The clamping part 110 is locked with the locking piece 400. At the same time, the actuating part 135 drives the second tube 214 to move from the distal end to the proximal end, so that the second resisting structure 211-2 is separated from the second matching part 460 of the locking piece 400, and the locking piece 400 is released from the sheath 210.

[0221] Figure 35 is an exemplary structural diagram of the second tube 214 of the sheath tube 210 according to other embodiments of the present disclosure. Figure 36 is an exemplary structural diagram of the first tube 213, the second tube 214 and the locking member 400 according to other embodiments of the present disclosure.

[0222] As shown in Figures 32, 35, and 36, in some embodiments, the distance between the second retaining structure 211-2 and the distal end of the second tubular member 214 is configured such that, after the locking member 400 is released from the second tubular member 214, the locking member 400 is locked with the clamping portion 110. For example, when the second tubular member 214 is connected to the locking member 400, the locking member 400 is entirely contained within the interior of the second tubular member 214. When the clamping portion 110 is closed, the actuating portion 135 of the clamping portion 110 first contacts the distal end of the second tubular member 214. The actuating portion 135 then moves the second tubular member 214 from the distal end toward the proximal end, causing the second retaining structure 211-2 to separate from the second mating portion 460 of the locking member 400, thereby releasing the locking member 400 from the sheath 210. The clamping portion 110 continues to move from the distal end to the proximal end, so that the first limiting structure 133 of the locked portion 130 cooperates with the first stop structure 420 of the locking member 400, and the second limiting structure 134 of the locked portion 130 cooperates with the second stop structure 430 of the locking member 400, and the clamping portion 110 is locked with the locking member 400.

[0223] 37 to 50 are exemplary structural diagrams illustrating the operation process of the clip instrument 10 according to some embodiments of the present specification. The operation process can be applied to any of the clip instruments 10 of the first embodiment and the clip instruments 10 of the second embodiment.

[0224] As shown in Figures 37 and 38 , the clamping portion 110 is in an open state. In some embodiments, the operating unit controls the core shaft 220 to move from the proximal end to the distal end, and the core shaft 220 drives the extension portion 120 and the clamping portion 110 to move from the proximal end to the distal end, so that the distal end of the extension portion 120 extends outside the passage of the sheath tube 210. At least two clamping portions 110 move away from each other and are in an open state, forming a clamping space 20 for clamping tissue between the at least two clamping portions 110.

[0225] As shown in Figures 39 and 40 , the clamping portion 110 is in a closed state. In some embodiments, the operating unit controls the core shaft 220 to move from the distal end to the proximal end, and the core shaft 220 drives the extension portion 120 and the clamping portion 110 to move from the distal end to the proximal end, so that the distal end of the extension portion 120 is retracted into the channel of the sheath tube 210. At least two clamping portions 110 are close to each other in a closed state, and tissue is clamped between the at least two clamping portions 110.

[0226] As shown in Figures 41 and 42, the locking member 400 is released from the sheath 210. In some embodiments, the sheath 210 includes a first tube 213 and a second tube 214. The proximal end of the clamping portion 110 abuts against the surface of the distal end of the second tube 214 and pushes the second tube 214 to move from the distal end to the proximal end relative to the first tube 213. The second resisting structure 211-2 has a tendency to move proximally relative to the locking member 400, causing the second resisting structure 211-2 to be deformed, displaced, or broken by the force and released from the limiting surface of the locking member 400. At this time, the locking member 400 is released from the sheath 210.

[0227] As shown in Figures 43 and 44 , in some embodiments, after the locking member 400 and the sheath 210 are released, the clamping portion 110 enters a pre-locked state. In some embodiments, the operating unit controls the core shaft 220 to move from the distal end to the proximal end, and the second limiting structure 134 of the locked portion 130 abuts against the contact portion 440 of the locking member 400, generating feedback resistance that prevents the clamping portion 110 from moving from the distal end to the proximal end. After feeling the feedback resistance, the operator can confirm again the clamping status of the clamping part 110 on the tissue. If the clamping part 110 does not clamp the tissue normally, the core shaft 220 is pushed from the proximal end to the distal end to change the clamping part 110 from a closed state to an open state to re-clamp the tissue. If the clamping part 110 clamps the tissue normally, the core shaft 220 is pulled from the distal end to the proximal end to cause the locking spring to be deformed by the force, and the bent portion passes over the contact portion 440 and enters the accommodating cavity 410 to cooperate with the locking recess, and the clamping part 110 enters the final locking state.

[0228] As shown in Figures 45 to 47 , the clamp arm 100 is in a locked state. In some embodiments, the operating unit controls the core shaft 220 to continue moving from the distal end to the proximal end, the second limiting structure 134 of the locked portion 130 passes over the contact portion 440 and engages with the second stop structure 430 of the locking member 400, and the first limiting structure 133 of the locked portion 130 engages with the first stop structure 420 of the locking member 400, thereby locking at least two clamping portions 110.

[0229] As shown in Figures 48 to 50, the clamping portion 110 and the locking element 400 are released from the sheath 210. In some embodiments, the extension portion 120 continues to move from the distal end to the proximal end, and the abutment portion 212 of the sheath 210 abuts the trigger portion 121, causing the trigger portion 121 to trigger the first connecting structure 111 or the second connecting structure 122 to break, deform, or displace, releasing the other. At this time, the extension portion 120 is released from the clamping portion 110. The extension portion 120 is retracted into the sheath 210 and withdrawn from the body, while the clamping portion 110 and the locking element 400 remain at the tissue wound, assisting in closing the tissue wound.

[0230] Embodiment 3 of this specification provides an operating method of a clamp instrument 10 , which is applicable to the clamp instrument 10 shown in any of the above embodiments.

[0231] Example 3 of this specification provides an exemplary clamp device 10. It should be noted that the clamp device 10 of Example 3 has many similarities or similarities with the clamp device 10 of Example 1 and the clamp device 10 of Example 2, and their design concepts, structures, and features can be mutually referenced and quoted.

[0232] Traditional clip instruments are prone to accidental separation of the locking part and the clamping part due to factors such as the long length of the clamping part and the storage tube or the loose locking, when subjected to the disturbance force of the surrounding environment in the narrow environment of the body, which is not conducive to wound healing.

[0233] Based on the above-mentioned defects, the clamp devices in Examples 3 and 4 of this specification improve the connection stability and reliability between the locking member and the clamping part and reduce the risk of accidental detachment by various means such as arranging the locking member between multiple clamping parts, or by reducing the length of the clamping part, or by changing the matching structure between the locking member and the clamping part.

[0234] FIG. 51 is a block diagram illustrating an exemplary structure of a clip instrument 10 according to some embodiments of the present specification.

[0235] As shown in FIG. 51 , the present specification provides a clip instrument 10 in some embodiments. The clip instrument 10 includes a sheath 210 , a clip arm 100 , and a locking element 400 .

[0236] In some embodiments, the sheath 210 includes a channel that is used to accommodate control structures such as the mandrel 220 and at least a portion of the clamp arm 100 (such as the extension 120 ), the locking member 400 , and other structures.

[0237] In some embodiments, the clamp arm 100 includes at least two clamping portions 110 and at least two extension portions 120. The proximal ends of the extension portions 120 are connected to the core shaft 220 and are releasably connected to the clamping portions 110. The term "releasably connected" in the embodiments of this specification may mean that the two components remain connected when a preset condition is met (e.g., when the external force is less than a preset threshold), and are released and separated from each other when the preset condition is not met (e.g., when the external force is greater than a preset threshold).

[0238] In some embodiments, the extension portion 120 can be in an extended state and a retracted state. For example, in the extended state, the distal end of the extension portion 120 extends beyond the passageway of the sheath tube 210, maintaining a predetermined distance between the proximal end of the clamping portion 110 and the distal end of the sheath tube 210. This predetermined distance can be determined based on the size of the surrounding space, the structural characteristics of the extension portion 120, and other factors. When the extension portion 120 extends beyond the passageway of the sheath tube 210, the predetermined distance between the proximal end of the clamping portion 110 and the distal end of the sheath tube 210 is maintained, thereby optimizing the clamping space 20, for example, by providing a larger opening span for the clamping portion 110.

[0239] In some embodiments, the clamping portion 110 includes a first clamping portion 110-1 and a second clamping portion 110-2. When the clamping portion 110 is in an open state, the distal end of the first clamping portion 110-1 and the distal end of the second clamping portion 110-2 are separated, and the extension portion 120 can also separate the proximal end of the first clamping portion 110-1 and the proximal end of the second clamping portion 110-2, thereby providing the clamping portion 110 with a sufficiently large span to clamp more tissue.

[0240] In some embodiments, in the retracted state, the extension portion 120 is received within the channel of the sheath 210 and closes at least two clamping portions 110. For example, the extension portion 120 moves from the distal end to the proximal end, and the sheath 210 squeezes the extension portion 120 to bring the clamping portions 110 closer to each other until the clamping portions 110 are closed.

[0241] In some embodiments, when the clamping portion 110 is closed or locked, the distal end of the first clamping portion 110-1 and the distal end of the second clamping portion 110-2 abut against each other (or abut against the clamped tissue) and close, and the proximal end of the first clamping portion 110-1 and the proximal end of the second clamping portion 110-2 also abut against each other and close. In some embodiments, after the clamping portion 110 is locked, the extension portion 120 can be released from the clamping portion 110, and the extension portion 120 and the sheath 210 can be withdrawn from the endoscope channel, while the clamping portion 110 and the locking member 400 remain in the body. By releasably connecting the clamping portion 110 and the extension portion 120, the extension portion 120 and the conveying portion 200 that are not in contact with the tissue can be withdrawn outside the body, while the clamping portion 110 remains in the body and continues to clamp the wound, thereby promoting wound healing.

[0242] In some embodiments, each clamping portion 110 includes an interlocking structure 112, and the extension portion 120 is releasably connected to the interlocking structure 112. For example, at least a portion of the distal end of the extension portion 120 is releasably connected to the interlocking structure 112. For more exemplary embodiments of the interlocking structure, please see FIG. 56 and the related description.

[0243] In some embodiments, the locking member 400 is releasably disposed within the channel of the sheath 210 and between the at least two extensions 120. In some embodiments, the locking member 400 is operably coupled with the interlocking structure 112 of the at least two clamping portions. When the interlocking structure 112 engages with the locking member 400, the at least two clamping portions 110 are in a locked state. The term "operably coupled" means that the interlocking structure 112 and the locking member 400 can be coupled from an uncoupled state through manipulation.

[0244] In some embodiments, the locking member 400 is releasably engaged with the sheath 210. When subjected to an external force, the locking member 400 can be released from the sheath 210 and removed from the passageway of the sheath 210. In some embodiments, at least two passages are formed between the two sides of the locking member 400 and the inner wall of the passageway of the sheath 210, each passage allowing the extension portion 120 to pass from the passageway of the sheath 210 to the outside of the passageway of the sheath 210.

[0245] According to the solution in the above embodiment, the interlocking structure 112 can cooperate with both the extension portion 120 and the locking member 400, integrating the connection and locking functions into the interlocking structure 112, making the overall structure more compact and the clamping portion 110 smaller in size. Furthermore, the placement of the locking member 400 within the channel of the sheath tube 210 reduces the size of the locking member 400, and the size of the locking member 400 when combined with the clamping portion 110 is also smaller. Compared to a conventional clamping portion 110, the retention length of the locking member 400 and the clamping portion 110 can be reduced by 30% to 70%. The small-sized locking piece 400 and the clamping portion 110 are less likely to be disturbed by the environment in the narrow space inside the body, thereby avoiding accidental separation of the clamping portion due to external force; in addition, the locking piece 400 is arranged on the inner side of the extension portion 120, which solves the problem of the limited opening angle of the extension portion 120, that is, the opening angle of the extension portion 120 is not limited by the locking piece 400, so that the clamping portion 110 obtains a larger clamping space 20.

[0246] FIG. 52 is an exemplary structural block diagram of a clip instrument 10 according to other embodiments of the present specification.

[0247] As shown in FIG. 52 , the present specification provides a clip instrument 10 in some embodiments. The clip instrument 10 includes a sheath 210 , a clip arm 100 , and a locking element 400 .

[0248] In some embodiments, the sheath 210 includes a channel that is used to accommodate a control structure such as a mandrel 220 (mandrel 220 is shown in FIG. 54 ), and to accommodate at least a portion of the clamp arm 100 , a locking member 400 , and other structures.

[0249] In some embodiments, the clamping arm 100 includes at least two clamping portions 110, and a clamping space 20 is formed between the at least two clamping portions 110. In some embodiments, the clamping portions 110 include an open state and a closed state. In the open state, the at least two clamping portions 110 move away from each other, allowing tissue (such as human organ tissue) to enter the clamping space 20. In the closed state, the at least two clamping portions 110 move closer to each other, confining the tissue within the reduced clamping space 20, thereby promoting the closure of the tissue wound.

[0250] In some embodiments, an interlocking structure 112 is provided on the side of the clamping portion 110 facing the clamping space 20. A locking member 400 is releasably disposed within the passage of the sheath 210, and the locking member 400 operably cooperates with the interlocking structure 112, locking at least two clamping portions 110. Because the interlocking structure 112 is disposed on the side of the clamping portion 110 facing the clamping space 20, the locking member 400 locks the interlocking structure 112 inside at least two clamping portions 110, eliminating the space outside the clamping portions 110. This makes the closed structure of the clamping portions 110 more compact and smaller, thereby reducing the probability of the clamping portions 110 being disturbed by external forces within the narrow space within the body.

[0251] In some embodiments, the locking member 400 includes a stop structure 471, and the interlocking structure 112 includes a locked portion 130. When engaged, the stop structure 471 and the locked portion 130 can restrict the two to a predetermined relative position or a predetermined relative motion range. The stop structure 471 includes, but is not limited to, various types of structures, such as protrusions, blocks, stop pins, spring clips, and stop slots.

[0252] In some embodiments, when the locked portion 130 is subjected to a force in the first direction applied by the stop structure 471 that is greater than or equal to a third preset force value, the locked portion 130 undergoes elastic deformation. After the locked portion 130 moves to the locking position of the stop structure 471, the locking member 400 is locked with the clamping portion 110. The locking position refers to the position where the locked portion 130 and the stop structure 471 form a limited fit. In some embodiments, when the locked portion 130 is subjected to a force in the second direction applied by the stop structure 471, the deformation of the locked portion 130 is limited. The second direction is the relative movement direction between the stop structure 471 and the locked portion 130, such as the axial direction of the sheath 210. The first direction is not parallel to the second direction. For example, the first direction includes any direction perpendicular to the second direction, or can be understood as the width direction or thickness direction of the clamping portion 110.

[0253] Through the cooperation between the locking member 400 and the interlocking structure 112 in the above embodiment, after the locking member 400 cooperates with the interlocking structure 112, the clamping portion 110 is locked. If the clamping portion 110 is disturbed by an external force, causing the locking member 400 and the clamping portion 110 to separate, the locking member 400 will have a tendency to move relative to the clamping portion 110 in the second direction, while the locked portion 130 will not deform even if a force is applied in the second direction, so that the stop structure 471 cannot separate from the locked portion 130, and the locking member 400 and the clamping portion 110 remain in a cooperative state. In short, the above-mentioned structure of the stop structure 471 and the locked portion 130 can improve the cooperation reliability and stability of the locking member 400 and the clamping portion 110, and enhance the ability of the clamping portion 110 and the locking member 400 to resist external force disturbances.

[0254] FIG. 53 is an exemplary structural block diagram of a clip instrument 10 according to yet other embodiments of the present specification.

[0255] As shown in FIG. 53 , the present specification provides a clip instrument 10 in some embodiments. The clip instrument 10 includes a sheath 210 , a clip arm 100 , and a locking element 400 .

[0256] In some embodiments, the sheath 210 includes a channel that is used to accommodate a control structure such as a mandrel 220 (mandrel 220 is shown in FIG. 54 ), and to accommodate at least a portion of the clamp arm 100 , a locking member 400 , and other structures.

[0257] In some embodiments, the clamp arm 100 is used to clamp a tissue wound, and the locking member 400 is used to lock the clamp arm 100 to keep the tissue wound closed.

[0258] In some embodiments, the sheath 210 includes a retaining structure 211, through which the locking element 400 is releasably positioned within the passageway of the sheath 210. In some embodiments, the retaining structure 211 can limit the axial movement of the locking element 400 along the sheath 210. The retaining structure 211 is configured to fail due to breakage, displacement, or deformation, thereby preventing the locking element 400 from being restricted from proximal to distal movement, allowing the locking element 400 to be released from the sheath 210. By positioning the locking element 400 within the passageway of the sheath 210, the locking element 400 is more compact, reducing the probability of external environmental disturbances. Furthermore, the locking element 400 and the sheath 210 are engaged via the retaining structure 211. When the clamping portion 110 is opened or closed, the clamping portion 110 and the locking element 400 do not contact each other, and movement of the clamping portion 110 or other components (such as the extension 120) does not affect the connection stability of the locking element 400.

[0259] In some embodiments, the resisting structure 211 includes a response portion 2111, which is configured to drive the resisting structure 211 to disengage from the locking member 400 under preset conditions, thereby releasing the locking member 400 from the sheath 210. By providing the response portion 2111, the locking member 400 is released only when the preset conditions are met, thereby preventing accidental release and improving the safety of the clip device 10. Furthermore, in some application scenarios, the response portion 2111 is triggered only after the clamping portion 110 is in a closed state or before the locked state, and the preset conditions are met, thereby releasing the locking member 400 from the sheath 210. This facilitates precise control of the operating steps of the clip device 10 and reduces operational complexity.

[0260] In some embodiments, the preset conditions include, but are not limited to: the response portion 2111 being subjected to a force radially along the sheath tube 210 that is greater than a second preset force value; the area of ​​the response portion 2111 being squeezed is greater than a preset area; and the like. In some embodiments, when the response portion 2111 meets the preset conditions, the resisting structure 211 deforms radially outward along the sheath tube 210, disengaging the resisting structure 211 from the locking member 400. For more exemplary embodiments of the response portion 2111, please refer to Figures 61 to 66 and the related descriptions.

[0261] The following describes in detail some exemplary structures of the clip device 10 according to the third embodiment. It should be noted that, under the guidance of this specification, those skilled in the art may combine and modify the features of the various embodiments described below and above in various ways, and such combinations and modifications remain within the scope of this specification. Furthermore, the embodiments described below are for illustrative purposes only and do not limit the scope of application of this specification.

[0262] FIG. 54 is a partial cross-sectional view of the clamp arm 100 and the delivery portion 200 according to some embodiments of the present disclosure.

[0263] As shown in FIG54 , the clamp arm 100 includes at least two clamping portions 110, at least two extension portions 120, and a locking element 400. The delivery portion 200 includes a sheath 210 and a core shaft 220. In some embodiments, the locking element 400 is releasably disposed within the passageway of the sheath 210. In some embodiments, the clamping portions 110 and the extension portions 120 are releasably connected. In some embodiments, the clamping portions 110 and the extension portions 120 are integrally formed.

[0264] In some embodiments, when the clamping portion 110 is in the open position, at least two clamping portions 110 are spaced apart from each other, the distal end of the extension portion 120 extends outside the passageway of the sheath tube 210, and the clamping portion 110 is located outside the passageway of the sheath tube 210. The locking member 400 is releasably engaged with the sheath tube 210 via the retaining structure 211 and is located within the passageway of the sheath tube 210. In some embodiments, when the clamping portion 110 is in the open position, the interlocking structure 112 is connected to the extension portion 120 and is located outside the passageway of the sheath tube 210, and the locking member 400 is located within the passageway of the sheath tube 210.

[0265] In some embodiments, when the clamping portions 110 are in a closed state, at least two clamping portions 110 are close to each other and in contact with the locking member 400, with the locking member 400 located between the at least two clamping portions 110. The interlocking structure 112 is connected to the extension portion 120, with at least a portion of the extension portion 120 located outside the passageway of the sheath 210. When at least a portion of the extension portion 120 is retracted into the passageway of the sheath 210, at least two clamping portions 110 remain outside the passageway of the sheath 210. During the operation of the clamping portions 110 to clamp tissue, the clamping portions 110 remain outside the passageway of the sheath 210, preventing the distal end of the sheath 210 from contacting the tissue, thereby improving the stability of the tissue clamping within the clamping space 20.

[0266] In some embodiments, when the clamping portion 110 is in the locked state, at least portions of at least two clamping portions 110 extend into the passageway of the sheath 210, and the at least two clamping portions 110 engage with the locking element 400. For example, the interlocking structure 112 of the clamping portion 110 forms a limited engagement with the locking element 400, with the locking element 400 positioned between the at least two clamping portions 110. At least two clamping portions 110 are locked. In some embodiments, when the clamping portion 110 is in the locked state, the interlocking structure 112 is simultaneously connected to the extension portion 120 and the locking element 400, and both the interlocking structure 112 and the locking element 400 are positioned within the passageway of the sheath 210. In some embodiments, the locking process of the clamp arm 100 includes: when the extension portion 120 engages with the interlocking structure 112, the extension portion 120 drives the interlocking structure 112 to move from the distal end to the proximal end until at least a portion of the interlocking structure 112 engages with the locking element 400.

[0267] In some embodiments, the clamping portion 110 includes a pre-release state, which is executed before, simultaneously with, or after the locking state. The pre-release state includes: the interlocking structure 112 and the extension portion 120 are connected, the locking member 400 is disengaged from the resisting structure 211 of the sheath 210, the locking member 400 is released from the sheath 210, and the interlocking structure 112 and the locking member 400 are still located in the channel of the sheath 210.

[0268] In some embodiments, when the clamping portion 110 is in a released state, the locking piece 400 is disengaged from the resisting structure 211 of the sheath 210, the connection between the interlocking structure 112 and the extension portion 120 is released, the extension portion 120 and the clamping portion 110 are released, and the locking piece 400 is engaged with the interlocking structure 112, so that at least two clamping portions 110 are released as a whole from the distal end of the sheath 210 to the outside of the sheath 210 channel in a locked state and remain at the tissue wound, and other components such as the extension portion 120, the sheath 210, and the core shaft 220 are withdrawn from the human body.

[0269] In some embodiments, the sheath 210 includes a fixed section 230 and a rotating section 240. The proximal end of the rotating section 240 is rotatably connected to the distal end of the fixed section 230, and the rotating section 240 is configured to rotate about the axis of the sheath 210. In some embodiments, one of the rotating section 240 and the fixed section 230 is provided with an annular groove, and the other is provided with a slider. For example, the slider is an annular slider that rotatably engages with the annular groove to enable the rotating section 240 to rotate relative to the fixed section 230. For example, the slider is a dot-shaped protrusion that slidably engages with the annular groove to enable the rotating section 240 to rotate relative to the fixed section 230. In some embodiments, the annular groove extends along the circumference of the sheath 210, and the annular slider is embedded in the annular groove to limit the axial displacement of the rotating section 240 and the fixed section 230 relative to the sheath 210. In some embodiments, the operating handle controls the rotation of the mandrel 220, and the rotation of the mandrel 220 causes the clamp arm 100 and the rotating section 240 to rotate simultaneously relative to the fixed section 230. By providing the rotating section 240 , the clamp arm 100 can rotate around the axis of the sheath tube 210 , and the closing direction of at least two clamping parts 110 can be more conveniently adjusted to be consistent with the closing direction of the tissue wound, thereby improving the accuracy of clamping the tissue wound.

[0270] In some embodiments, the sheath tube 210 is an integrally formed structure, which facilitates processing and saves costs.

[0271] Figure 55 is an exemplary structural diagram of an extension portion 120 according to some embodiments of the present specification. Figure 56 is an exemplary structural diagram of a clamping portion 110 according to some embodiments of the present specification. Figure 57 is an exemplary structural diagram of the extension portion 120 and the clamping portion 110 according to some embodiments of the present specification.

[0272] As shown in Figures 55 to 57, in some embodiments, the clamping portion 110 includes an interlocking structure 112, the interlocking structure 112 includes a first connecting structure 111, and the extension portion 120 includes a second connecting structure 122. The first connecting structure 111 and the second connecting structure 122 can be releasably connected, so that the clamping portion 110 can be released from the extension portion 120.

[0273] In some embodiments, the second connection structure 122 includes two elastic arms, each of which includes a distal portion 123, a middle portion 124, and a proximal portion 125. The middle portion 124 of the elastic arm is configured as a connection recess 1221. In some embodiments, the interlocking structure 112 includes two interlocking plates, which respectively start from the two sides of the proximal end of the clamping portion 110 and are rolled toward the central axis of the clamping portion 110. A connection groove 113 is formed between the interlocking plates and the clamping portion 110, and the connection groove 113 constitutes the first connection structure 111. The central axis of the clamping portion 110 refers to the axis extending along the length direction of the clamping portion 110 and located in the middle of the clamping portion 110. In some embodiments, when the first connecting structure 111 is connected to the second connecting structure 122, the two elastic arms pass through the connecting groove 113, so that the connecting recess 1221 of the elastic arms engages with the connecting groove 113. The inner side surface of the distal end of the connecting recess 1221 abuts and stops against the distal surface of the connecting groove 113, and the inner side surface of the proximal end of the connecting recess 1221 abuts and stops against the proximal surface of the connecting groove 113. In some embodiments, the distal end 123 of the elastic arm is formed with an inclined surface, which is used to guide the extension portion 120 into the connecting groove 113, making it easier for the extension portion 120 to engage with the clamping portion 110.

[0274] In some embodiments, the inner side surface of the distal end of the connecting recess 1221 and the distal surface of the connecting groove 113 are both perpendicular to the axial direction of the extension portion 120, and / or the inner side surface of the proximal end of the connecting recess 1221 and the proximal surface of the connecting groove 113 are both perpendicular to the axial direction of the extension portion 120. The axial direction of the extension portion 120 may be the direction indicated by arrow D2 in FIG57. When the extension portion 120 moves from the distal end to the proximal end, the connecting recess 1221 and the connecting groove 113 form a stop, which keeps the clamping portion 110 and the extension portion 120 connected, preventing the clamping portion 110 and the extension portion 120 from pulling against each other due to axial force and causing accidental separation.

[0275] In some embodiments, the extension portion 120 or the clamping portion 110 includes a trigger portion 121, which is configured to trigger the extension portion 120 and the clamping portion 110 to release when subjected to a force in a first direction greater than a first preset force value; wherein the first direction is non-parallel to the movement direction of the extension portion 120. For example, the first direction can be the direction indicated by the arrow D1 in Figure 57, or the first direction can be the width direction of the clamping portion 110, or the first direction can also be a direction at an angle to the width direction of the clamping portion 110. In the process of the extension portion 120 driving the clamping portion 110 to move from the distal end to the proximal end, when the clamping portion 110 is locked and the locking member 400 is released from the sheath 210, a pulling force along the movement direction of the extension portion 120 will be generated between the extension portion 120 and the clamping portion 110. By setting the trigger portion 121, the extension portion 120 can be released from the clamping portion 110 only when it is triggered by the trigger portion 121, which can avoid accidental detachment of the extension portion 120 and the clamping portion 110 due to the pulling force along the movement direction between the extension portion 120 and the clamping portion 110, thereby reducing the surgical risk.

[0276] In some embodiments, the trigger portion 121 is disposed on the second connection structure 122 . For example, a slope is disposed at the proximal end of the elastic arm, and the slope constitutes the trigger portion 121 .

[0277] In some embodiments, the locking member 400 includes a first abutting portion 480 (as shown in FIG. 58 ). The first abutting portion 480 is used to drive the trigger portion 121, causing the distal end of the extension portion 120 to break, deform, or displace, thereby releasing the extension portion 120 from the clamping portion 110. For example, the first abutting portion 480 can be a protrusion provided at the proximal end of the locking member 400. When the trigger portion 121 contacts the first abutting portion 480, that is, when the protrusion of the locking member 400 contacts the inclined surface at the proximal end of the elastic support arm of the extension portion 120, the force exerted by the protrusion on the inclined surface can cause the two elastic support arms to deform and move closer together, thereby disengaging the connecting recess 1221 on the elastic support arm from the connecting groove 113 of the interlocking structure 112, thereby releasing the extension portion 120 from the clamping portion 110. In other embodiments, the first abutting portion 480 can also include, but is not limited to, the end surface of the distal end of the sheath tube 210 or a protrusion (such as a stop structure, etc.) provided within the channel of the sheath tube 210.

[0278] In some embodiments, a gap is formed between the two elastic arms of the extension portion 120, and the proximal end of the gap is formed into a V-shaped groove. The V-shaped groove makes it easier for the two elastic arms to deform, making it easier for the extension portion 120 and the clamping portion 110 to be released.

[0279] Figure 58 is an exemplary structural diagram of a locking member 400 according to some embodiments of the present specification. Figure 59 is an exemplary structural diagram of a locking member 400 locked with a clamping portion 110 according to some embodiments of the present specification. Figure 60 is a partial cross-sectional view of a locking member 400 locked with a clamping portion 110 according to some embodiments of the present specification.

[0280] As shown in Figures 56 and 58 to 60, in some embodiments, the interlocking structure 112 further includes a locked portion 130, which is used to lock with the locking member 400. In some embodiments, the interlocking structure 112 includes two interlocking pieces rolled from both sides of the clamping portion 110, and the ends of the two interlocking pieces constitute the locked portion 130. In some embodiments, the interlocking structure 112 is configured to have a relatively wide dimension in the second direction, so that the locked portion 130 also has a relatively wide dimension in the second direction, thereby improving the stability of the locking.

[0281] In some embodiments, the size of the clamping portion 110 in the second direction is approximately in the range of 4 mm to 15 mm. If the size of the clamping portion 110 in the second direction is less than 4 mm, it is difficult to clamp the wound. If the size of the clamping portion 110 in the second direction is greater than 15 mm, it is difficult to pass through the endoscope delivery channel. Based on this, setting the size of the clamping portion 110 in the second direction within the above range can not only effectively close the wound, but also smoothly pass through the endoscope delivery channel. In some embodiments, the size of the clamping portion 110 in the second direction can be set to about 6.5 mm, so that it takes into account both the reliability of clamping and the compactness of the structure. In other embodiments, the size of the clamping portion 110 in the second direction can be set to 8 mm, 10 mm, 12 mm, etc.

[0282] In some embodiments, the dimension of the interlocking structure 112 in the second direction is approximately in the range of 0.5 mm to 4 mm. If the dimension of the interlocking structure 112 in the second direction is less than 0.5 mm, it will affect the connection stability between the first connecting structure 111 and the second connecting structure 122 of the extension portion 120, as well as the reliability of the fit between the locked portion 130 and the locking member 400. If the dimension of the interlocking structure 112 in the second direction is greater than 4 mm, it will occupy the clamping space 20 between the clamping portions 110, affecting the ability of the clamping portion 110 to clamp a sufficient amount of tissue. Based on this, setting the dimension of the interlocking structure 112 in the second direction within the above range can not only ensure the connection stability between the first connecting structure 111 and the second connecting structure 122 of the extension portion 120, as well as the reliability of the fit between the locked portion 130 and the locking member 400, but also provide the clamping portion 110 with sufficient clamping space 20 to clamp a sufficient amount of tissue, thereby improving the connection stability between the clamping portion 110 and the tissue. In some embodiments, the dimension of the interlocking structure 112 in the second direction can be set to approximately 1 mm, which can ensure the stability and reliability of the connection with the extension portion 120 and the locking member 400, while also making the clamping space 20 of the clamping portion 110 large enough to clamp a sufficient amount of tissue and effectively close the wound. In other embodiments, the dimension of the interlocking structure 112 in the second direction can be set to 2 mm, 3 mm, etc.

[0283] In some embodiments, the ratio of the size of the interlocking structure 112 to the size of the clamping portion 110 in the second direction is within a range of 0.05 to 0.5. In some embodiments, the ratio of the size of the interlocking structure 112 to the size of the clamping portion 110 in the second direction is within a range of 0.1 to 0.3. In some embodiments, the ratio of the size of the interlocking structure 112 to the size of the clamping portion 110 includes, but is not limited to, 0.15, 0.2, 0.25, 0.3, 0.35, etc. By adjusting the ratio of the interlocking structure 112 to the clamping portion 110 within the above range, the functions of the interlocking structure 112 and the clamping portion 110 are ensured while making the overall structure more compact and lightweight. For example, the interlocking structure 112 and the extension portion 120 have a strong connection stability, the interlocking structure 112 also cooperates with the locking member 400 with high reliability, and the two clamping portions 110 also have sufficient control to clamp the tissue, thereby achieving effective closure of the tissue wound.

[0284] In some embodiments, the locked portion 130 of the interlocking structure 112 is configured to be elastically deformed and locked with the stop structure 471 when subjected to force in a first direction, and to be limited in deformation when subjected to force in a second direction. The second direction is the direction indicated by arrow D2 in FIG. 56 , which can be understood as the length direction of the clamping portion 110 . The first direction includes any direction perpendicular to the second direction, such as the direction indicated by arrow D1 in FIG. 56 , or can be understood as the width direction or thickness direction of the clamping portion 110 .

[0285] In some embodiments, a stop structure 471 is disposed on radially opposite sides of the locking member 400. For example, the locking member 400 includes a main body 470 and a stop structure 471 disposed on either side of the main body 470. The stop structure 471 is configured to engage with the locked portion 130 to lock the clamping portion 110 to the locking member 400. In some embodiments, the stop structure 471 includes a guide pin 472 and at least one locking protrusion 473. The guide pin 472 is arranged along the second direction to guide the stop structure 471 into the locked portion 130 along the second direction and engage with the locked portion 130 in the first direction. The locking protrusion 473 protrudes from at least one side of the guide pin 472 in the first direction. When engaged with the locked portion 130, the locking protrusion 473 can limit relative displacement in the second direction. In some embodiments, at least one locking protrusion 473 is formed on either side of the guide pin 472. The positions of the locking protrusions 473 on opposite sides can correspond in the second direction or be staggered. In some embodiments, a locking protrusion 473 is formed on one side of the guide pin 472. The number of the locking protrusions 473 includes but is not limited to 1, 2, 3, 4, and the like.

[0286] In some embodiments, the distal and proximal surfaces of the locking projection 473 are perpendicular to the second direction. When the locking projection 473 engages with the locked portion 130, the interaction force between the locking projection 473 and the locked portion 130 is perpendicular to the distal and proximal surfaces. In other words, the interaction force is perpendicular to the second direction, and the locking projection 473 is configured to be subjected to force in the second direction and thus limited in deformation. This can prevent the locking projection 473 from being dislodged from the locked portion 130, thereby improving the locking security and stability.

[0287] In some embodiments, the interlocking structure 112 includes interlocking plates located on either side of the clamping portion 110. The interlocking plates include a fixed portion connected to the side of the clamping portion 110 and a suspended portion oriented toward the central axis of the clamping portion 110. A guide groove 114 and a first locking groove 115 are formed between the two suspended portions. The guide groove 114 is adapted to fit the guide pin 472, and the first locking groove 115 is adapted to fit the locking protrusion 473. "Adapted" here can be understood as matching physical properties such as size, shape, and fixing method. For example, the size and shape of the guide groove 114 are designed to fit the guide pin 472, and the size and shape of the first locking groove 115 are designed to fit the locking protrusion 473. The cooperation between the guide pin 472 and the guide groove 114, and the cooperation between the locking protrusion 473 and the locking member, can limit the displacement of the locking member 400 and the clamping portion 110 in the first direction and the second direction, thereby improving locking stability.

[0288] In some embodiments, the overhanging portion is provided with an actuating ramp 116, which is arranged toward the proximal end of the clamping portion 110. When the guide pin 472 of the locking member 400 enters the guide slot 114, the locking protrusion 473 contacts the actuating ramp 116. The clamping portion 110 continues to approach the locking member 400, causing the locking protrusion 473 to apply a force to the actuating ramp 116. When the force applied to the actuating ramp 116 in the first direction is greater than or equal to a third predetermined force value, the two interlocking plates are elastically deformed in the first direction, causing the guide slot 114 to widen in the first direction. At this point, the locking protrusion 473 can enter the guide slot 114 and continue to enter the locking slot. After the locking protrusion 473 engages with the locking slot, the two interlocking plates return to their original shape, causing the guide slot 114 to engage with the guide pin 472, and the locking slot to engage with the locking protrusion 473, thereby locking the locking member 400 to the clamping portion 110.

[0289] In some embodiments, the clamping portion 110 includes a fixing ring 117 disposed on the distal side of the interlocking structure 112. The locking member 400 includes a retaining recess 474. When the clamping portion 110 and the locking member 400 are locked, the fixing rings 117 of at least two clamping portions 110 engage within the retaining recess 474. In some embodiments, the retaining recess 474 is disposed on the main body 470 of the locking member 400 and is recessed from the distal surface of the main body 470 toward the proximal end. By providing the fixing ring 117 and the retaining recess 474, the at least two clamping portions 110 can be restrained in the same retaining recess 474, maintaining a stable locking of the at least two clamping portions 110 and improving the reliability of the locking member 400.

[0290] In some embodiments, the locked portion 130 includes at least one limiting structure, and the locking member 400 includes at least one stopping structure. When the limiting structure and the stopping structure cooperate, the relative movement between the clamping portion 110 and the locking member 400 is restricted. For example, there is one limiting structure and one stopping structure. When the limiting structure and the stopping structure cooperate, the relative movement between the clamping portion 110 and the locking member 400 in all directions is restricted. For example, there are multiple limiting structures and multiple stopping structures. The cooperation of any one set of limiting structures and the stopping structure can restrict the movement of the clamping portion 110 and the locking member 400 in at least one direction, and the combination of all limiting structures and the stopping structures can fully restrict the movement of the clamping portion 110 and the locking member 400 in all directions. The cooperation between the limiting structure and the stopping structure can improve the locking stability between the clamping portion 110 and the locking member 400.

[0291] In some embodiments, the locked portion 130 includes a second limiting structure, and the locking member 400 includes a second stopping structure. The second limiting structure cooperates with the second stopping structure to limit relative movement between the clamping portion 110 and the locking member 400 in a second direction, wherein the second direction is non-parallel to the first direction. For example, the second direction includes the direction indicated by arrow D2 in FIG. 56 , such as the longitudinal direction of the clamping portion 110. The second stopping structure 430 is the first locking groove 115 described above, and the second limiting structure 134 is the locking protrusion 473 described above.

[0292] In some embodiments, the locking member 400 includes a third stop structure, and the accommodating cavity 410 of the locking member 400 constitutes the third stop structure. The locked portion 130 includes a third limiting structure, which is located on the side of the clamping portion 110 facing the clamping space 20. When the clamping portion 110 is in the closed state, the third limiting structure is located within the accommodating cavity 410, and the movement of at least two clamping portions 110 in the direction of separation and / or relative rotation is restricted. The third stop structure is a limiting recess 474, and the third limiting structure is a fixing ring 117.

[0293] In some embodiments, the locking member 400 includes a contact portion 440 located at a distal end of the locking member 400. The contact portion 440 is configured to provide feedback resistance to prompt the operator to enter the locked state. In some embodiments, the locking protrusion 473 of the locking member 400 is configured as the contact portion 440, which is configured to contact the actuation ramp 116 of the interlocking structure 112 and generate feedback resistance.

[0294] In some embodiments, when the resistance between the contact portion 440 and the actuation ramp 116 is less than a resistance threshold, the clamping portion 110 is in a pre-locked state. When the resistance between the contact portion 440 and the actuation ramp 116 is greater than or equal to the resistance threshold, the clamping portion 110 is in a locked state. In some embodiments, the resistance threshold ranges from 30N to 80N, and further, from 40N to 60N. Within this resistance threshold range, the operator can more easily and comfortably perform the locking process.

[0295] In some embodiments, the clamping portion 110 includes a pre-locking state and a final locking state.

[0296] In the pre-locking state, the actuating bevel 116 of the locked portion 130 abuts against the contact portion 440 (e.g., the locking protrusion 473) of the locking member 400, generating a feedback resistance that prevents the clamping portion 110 from moving from the distal end to the proximal end. This feedback resistance is fed back to the operator through the core shaft 220, prompting the operator that the clamping portion 110 is about to enter the locked state. In some embodiments, after feeling the feedback resistance, the operator can reconfirm the clamping state of the clamping portion 110 on the tissue. If the clamping portion 110 does not clamp the tissue normally, the operator pushes the core shaft 220 from the proximal end to the distal end to turn the clamping portion 110 from the closed state to the open state and re-clamp the tissue. If the clamping portion 110 clamps the tissue normally, the operator pulls the core shaft 220 from the distal end to the proximal end, causing the actuating bevel 116 to pass over the locking protrusion 473, which enters the locking groove 115, and the clamping portion 110 enters the final locked state. By providing the contact portion 440 and the actuating inclined surface 116 to form a feedback resistance, the operator can be prompted to confirm the tissue clamping status before locking, thereby reducing surgical errors.

[0297] In the final locking state, the actuating slope 116 passes over the contact portion 440, so that the locked portion 130 cooperates with the stop structure 471, that is, the locking protrusion 473 cooperates with the locking groove 115, and the guide pin 472 cooperates with the guide groove 114, and at least two clamping portions 110 are locked.

[0298] In some embodiments, the interlocking structure 112 is made of a metallic material, such as stainless steel, which offers advantages such as low cost and corrosion resistance. In other embodiments, the interlocking structure 112 can also be made of a non-metallic composite material, such as medical plastic. The material selection for the interlocking structure 112 can ensure that the elastic modulus of the interlocking structure 112 meets a predetermined condition. The predetermined condition includes that when the interlocking plate is subjected to a force greater than or equal to a resistance threshold, the interlocking plate elastically deforms in a first direction, allowing the locking member 400 to pass over the actuating ramp 116 and enter the locking groove.

[0299] FIG61 is an exemplary structural diagram of the distal end of the sheath tube 210 according to some embodiments of the present specification. FIG62 is a partial cross-sectional view of the distal end of the sheath tube 210 according to some embodiments of FIG61. FIG63 is an axial view of the distal end of the sheath tube 210 according to some embodiments of FIG61. FIG64 is an exemplary structural diagram of the locking member 400 engaged with the sheath tube 210 according to some embodiments of the present specification. FIG65 is a cross-sectional view of the locking member 400 engaged with the sheath tube 210 according to some embodiments of FIG64. FIG66 is an axial view of the locking member 400 engaged with the sheath tube 210 according to some embodiments of FIG64.

[0300] As shown in FIG. 58 and FIG. 61 to FIG. 66 , in some embodiments, the sheath tube 210 includes at least one retaining structure 211 , and the retaining structure 211 is used to limit the locking member 400 within the channel of the sheath tube 210 .

[0301] In some embodiments, the sheath 210 includes a first resisting structure 211-1, and the locking member 400 includes a first mating portion 450. The first resisting structure 211-1 cooperates with the first mating portion 450 to limit the movement and rotational movement of the locking member 400 from the distal end to the proximal end relative to the sheath 210, so that the locking member 400 can be maintained in the desired position, such as the distal end of the sheath 210.

[0302] In some embodiments, the first retaining structure 211-1 includes a limiting step, and the first mating portion 450 includes a limiting protrusion. The limiting step includes a U-shaped step surface with its opening facing the distal end, and the proximal end and sidewalls of the limiting protrusion engage with the U-shaped step surface. The bottom wall of the U-shaped step surface is used to limit the movement of the locking member 400 from the distal end to the proximal end relative to the sheath 210, and the sidewalls of the U-shaped step surface are used to limit the rotational movement of the locking member 400 relative to the sheath 210. By providing the U-shaped step surface, the locking member 400 is prevented from shaking within the sheath 210, thereby improving the locking accuracy between the interlocking structure 112 and the stop structure 471.

[0303] In some embodiments, the sheath 210 includes a first tubular member 213 and a second tubular member 214. The distal end of the first tubular member 213 is disposed inside the second tubular member 214, and a first retaining structure 211-1 is disposed at the distal end of the first tubular member 213. By arranging the first tubular member 213 and the second tubular member 214 to cooperate, it is convenient to machine the first retaining structure 211-1 at the distal end of the first tubular member 213, and then assemble the distal end of the first tubular member 213 into the second tubular member 214, thereby simplifying the processing difficulty. In some embodiments, a portion of the distal end surface of the first tubular member 213 is axially recessed to form a U-shaped stepped surface, or a portion of the distal end surface of the first tubular member 213 is axially protruded on both sides to form a U-shaped stepped surface.

[0304] In some embodiments, the limiting protrusion of the first matching portion 450 protrudes from the main body 470 of the locking member 400, and the limiting protrusion is located at the proximal end of the locking member 400 so as to be able to adapt to the U-shaped step surface.

[0305] In some embodiments, the sheath 210 includes a second retaining structure 211-2, and the locking member 400 includes a second mating portion 460. The second retaining structure 211-2 and the second mating portion 460 are releasably connected to each other to limit the movement of the locking member 400 from the proximal end to the distal end relative to the sheath 210. After the locking member 400 locks at least two clamping portions 110, the second retaining structure 211-2 separates from the second mating portion 460, and the locking member 400 is released from the sheath 210.

[0306] In some embodiments, the second resisting structure 211-2 includes at least one limiting spring clip, one end of which is connected to the inner wall of the sheath 210, and the other end protrudes radially inward from the inner wall of the sheath 210. The second matching portion 460 includes at least one limiting surface toward the distal end, and one end of the limiting spring clip protruding from the inner wall of the sheath 210 is releasably connected to the limiting surface.

[0307] In some embodiments, the distal end of the limiting spring is connected to the inner wall of the sheath 210, and the proximal end protrudes radially inward from the inner wall of the sheath 210. The distal surface of the first mating portion 450 constitutes a limiting surface (i.e., the second mating portion 460), and the proximal end of the limiting spring is releasably connected to the limiting surface. In some embodiments, the proximal end of the main body 470 of the locking member 400 is provided with a plurality (e.g., four) limiting protrusions at intervals along the circumference. Correspondingly, the sheath 210 includes a plurality (e.g., four) limiting springs at intervals along the circumference, each of which is respectively mated with the limiting surface. By having a plurality of limiting springs respectively mated with a plurality of limiting protrusions along the circumferential direction of the sheath 210, the connection stability of the locking member 400 within the sheath 210 can be improved.

[0308] As shown in FIG56 , in some embodiments, the clamp arm 100 includes an actuating portion 135. The actuating portion 135 is configured to actuate the release of the second retaining structure 211-2 and the second mating portion 460 when moving from the distal end to the proximal end, thereby releasing the locking member 400 from the sheath 210. The actuating portion 135 refers to a component or portion that can directly or indirectly cause the release of the second retaining structure 211-2 and the second mating portion 460. Providing the actuating portion 135 to actuate the release of the locking member 400 from the sheath 210 prevents other components or portions from disturbing the locking member 400 during movement, thereby reducing the risk of accidental release of the locking member 400.

[0309] In some embodiments, the resisting structure 211 includes a response portion 2111, which is configured to drive the resisting structure 211 to disengage from the locking member 400 under a preset condition, thereby releasing the locking member 400 from the sheath 210. In some embodiments, the actuator 135 is configured to contact the response portion 2111 when moving from the distal end to the proximal end, causing the response portion 2111 to meet a preset condition. In some embodiments, the preset condition includes, but is not limited to, the response portion 2111 being subjected to a force in the radial direction of the sheath 210 that is greater than a second preset force value.

[0310] In some embodiments, the response portion 2111 is provided on the second resisting structure 211-2 and protrudes from the second resisting structure 211-2 radially inwardly of the sheath tube 210. Alternatively, in some embodiments, a partial area of ​​the second resisting structure 211-2 is constructed as the response portion 2111. In some embodiments, the proximal end of the limiting spring is constructed as the response portion 2111. When the clamp arm 100 moves from the distal end to the proximal end, the actuating portion 135 can contact the response portion 2111 and generate a force on the response portion 2111 along the radial direction of the sheath tube 210 and greater than the second preset force value. The actuating portion 135 drives the response portion 2111 to cause the second resisting structure 211-2 to deform radially outwardly of the sheath tube 210. The second resisting structure 211-2 is disengaged from the limiting surface of the locking member 400, and the locking member 400 is released from the sheath tube 210.

[0311] In some embodiments, the actuating portion 135 is disposed on the locked portion 130 . For example, the actuating portion 135 is disposed on the interlocking structure 112 of the locked portion 130 , and at least part of the fixed portion of the interlocking plate of the interlocking structure 112 constitutes the actuating portion 135 to improve the strength of the actuating portion 135 .

[0312] In some embodiments, at least two clamping portions 110 further include a pre-release state, which is executed before, simultaneously with, or after the locking state. The pre-release state includes: the interlocking structure 112 is connected to the extension portion 120, the locking element 400 is released from the sheath 210, and the interlocking structure 112 and the locking element 400 are located within the channel of the sheath 210. In some embodiments, the pre-release state is executed before the locking state, with the locking element 400 first released from the sheath 210 and then locked with the clamping portion 110. This allows the locking element 400 to be directly separated from the sheath 210 after being locked with the clamping portion 110, thereby improving operational safety and reducing clinical risks. In other embodiments, the pre-release state is executed simultaneously with or after the locking state, i.e., the locking element 400 is first locked with the clamping portion 110 and then released from the sheath 210. In some embodiments, the order of the pre-release state and the locking state can be determined according to the setting position of the response part 2111 on the second resisting structure 211-2. When the interlocking structure 112 is close to the locking member 400, after the response part 2111 contacts the actuating part 135, the stop structure 471 cooperates with the locked part 130, and the pre-release state is executed before the locking state.

[0313] 67 to 76 are schematic diagrams of the operation process according to some embodiments of the present specification.

[0314] As shown in Figure 67, the clamping portion 110 is in an open state. In some embodiments, the operating unit controls the core shaft 220 to move from the proximal end to the distal end, and the core shaft 220 drives the extension portion 120 and the clamping portion 110 to move from the proximal end to the distal end, so that the distal end of the extension portion 120 extends outside the passage of the sheath tube 210. At least two clamping portions 110 move away from each other and are in an open state, forming a clamping space 20 for clamping tissue between the at least two clamping portions 110.

[0315] As shown in Figure 68, the clamping portion 110 is in a closed state. In some embodiments, the operating unit controls the core shaft 220 to move from the distal end to the proximal end, and the core shaft 220 drives the extension portion 120 and the clamping portion 110 to move from the distal end to the proximal end, so that the distal end of the extension portion 120 is retracted into the channel of the sheath tube 210. At least two clamping portions 110 are close to each other in a closed state, and tissue is clamped between the at least two clamping portions 110.

[0316] As shown in Figures 69 and 70, the clamping portion 110 is in a pre-locking state, and the extension portion 120 drives the interlocking structure 112 of the clamping portion 110 to approach the locking member 400. When the actuating slope 116 of the interlocking structure 112 abuts against the contact portion 440 of the locking member 400, and generates feedback resistance to prevent the clamping portion 110 from moving from the distal end to the proximal end, the feedback resistance is fed back to the operator through the core shaft 220, prompting the operator that the clamping portion 110 is about to enter the locking state.

[0317] As shown in FIG. 71 to FIG. 73 , the clamping portion 110 enters the locking state from the pre-locking state, and the locking member 400 and the sheath tube 210 are released.

[0318] The process of the clamping part 110 entering the locking state from the pre-locking state is as follows: the extension part 120 drives the clamping part 110 to continue to move from the distal end to the proximal end. In the pre-locking state, the guide pin 472 of the stop structure 471 partially enters the guide groove 114 of the interlocking structure 112, and the locking protrusion 473 of the stop structure 471 abuts against the actuating inclined surface 116, so that an interaction force is generated between the locking protrusion 473 and the actuating inclined surface 116. The interaction force can serve as a feedback resistance to prompt the operator. When the interaction force increases to reach the resistance threshold, the interlocking structure 112 produces elastic deformation along the first direction, so that the locking protrusion 473 passes over the actuating inclined surface 116 and enters the locking groove, and at least two clamping parts 110 are locked with the locking member 400.

[0319] The process of releasing the locking member 400 from the sheath 210 is as follows: when the clamping portion 110 is in the pre-locking state, the extension portion 120 drives the clamping portion 110 to move from the distal end to the proximal end, and the actuating portion 135 of the interlocking structure 112 actuates the response portion 2111 of the second resisting structure 211-2, causing the second resisting structure 211-2 to deform radially outward relative to the sheath 210, so that the limiting surface of the second resisting structure 211-2 and the locking member 400 is released, and the locking member 400 is released from the sheath 210.

[0320] As shown in Figures 74 and 75, the extension portion and the clamping portion are released. In some embodiments, the extension portion 120 continues to move from the distal end to the proximal end, and the first abutting portion 480 of the locking member 400 abuts against the trigger portion 121, causing the trigger portion 121 to trigger the second connecting structure 122 of the extension portion 120 to break, deform, or displace, thereby releasing the second connecting structure 122 of the extension portion 120 from the interlocking structure 112. At this time, the extension portion 120 and the clamping portion 110 are released. Specifically, after the protrusion of the locking member 400 contacts the inclined surface at the proximal end of the elastic support arm of the extension portion 120, the force applied by the protrusion on the inclined surface can cause the two elastic support arms to deform and move closer to each other, causing the connecting recess 1221 on the elastic support arm to disengage from the connecting groove 113 of the interlocking structure 112, and the extension portion 120 and the clamping portion 110 are released.

[0321] As shown in Figure 76, the clamping portion 110 and the locking member 400 are released from the sheath 210 together. At least two clamping portions and the locking member remain locked, and the entire assembly is released from the sheath channel, remaining within the tissue wound and assisting in wound closure. The sheath and other components, including the extension portion 120, are then withdrawn from the body.

[0322] Embodiment 4 of the present specification provides an exemplary clamp instrument 10, which is modified and improved based on the above embodiments. Some identical or corresponding features can be referred to the relevant descriptions of the above embodiments. In the following, only the parts of the clamp instrument 10 of embodiment 4 that are different from the clamp instruments 10 of embodiments 1 to 3 are described.

[0323] FIG. 77 is an exemplary structural diagram of a clamping portion according to some embodiments of the present specification.

[0324] As shown in FIG77 , compared to the third embodiment, the fourth embodiment modifies the interlocking structure 112 of the clamping portion 110. In some embodiments, the interlocking structure 112 includes two interlocking pieces, each having a bent structure. The bent structure includes a fixed portion, a receiving portion, and a suspended portion. The fixed portion is connected to the side of the clamping portion 110, and the receiving portion connects the fixed portion and the suspended portion to form at least one opening, which faces away from the central axis C of the clamping portion 110. The central axis C of the clamping portion 110 is shown as the axis in FIG77 . In some embodiments, a connecting groove 113 is formed between the bent structure and the clamping portion 110, and the connecting groove 113 is used to cooperate with the extension portion 120. In some embodiments, the suspended portion of the bent structure constitutes a locked portion 130, and the locked portion 130 is used to cooperate with the locking member 400.

[0325] FIG. 78 is an exemplary structural diagram of the clamping portion 110 and the extending portion 120 according to some embodiments of the present specification.

[0326] As shown in Figures 55, 77, and 78, in some embodiments, the bent structures of the two interlocking pieces are bent multiple times from both sides of the clamping portion 110 to form a C-shaped structure. A gap is formed between the C-shaped structure and the clamping portion 110, and this gap constitutes the connecting groove 113. The connecting recess 1221 at the distal end of the extension portion 120 cooperates with the connecting groove 113, allowing the extension portion 120 and the connecting groove 113 to be releasably connected.

[0327] In some embodiments, the extension 120 includes a trigger portion 121. For example, the proximal end of the elastic arm is provided with an inclined surface, which constitutes the trigger portion 121. In some embodiments, the sheath 210 includes a second abutment portion 212 (as shown in FIG. 58 ). The second abutment portion 212 is used to actuate the trigger portion 121, causing the distal end of the extension 120 to break, deform, or displace, thereby releasing the extension 120 from the clamping portion 110. For example, the second abutment portion 212 can be a portion of the distal end surface of the first tubular member 213 of the sheath 210. When the trigger portion 121 contacts the second abutment portion 212, i.e., when the distal end surface of the first tubular member 213 contacts the inclined surface of the proximal end of the elastic arm of the extension 120, the force exerted by the end surface on the inclined surface can cause the two elastic arms to deform and move closer together, thereby disengaging the connection recess 1221 on the elastic arm from the connection groove 113 of the interlocking structure 112, and releasing the extension 120 from the clamping portion 110. For more exemplary embodiments of the structure and release method of the extension portion, please refer to Figures 55 to 57 and their related descriptions.

[0328] Figure 79 is an exemplary structural diagram of a locking member 400 according to some embodiments of the present specification. Figure 80 is an exemplary structural diagram of a locking member 400 locked with a clamping portion 110 according to some embodiments of the present specification. Figure 81 is a partial cross-sectional view of a locking member 400 locked with a clamping portion 110 according to some embodiments of the present specification.

[0329] In some embodiments, the locking member 400 includes a first half 491 and a second half 492 spaced apart from each other. Second locking grooves 493 are formed on the facing surfaces of the first half 491 and the second half 492. Each second locking groove 493 constitutes a stop structure 471 for engaging with the locked portions 130 of at least two clamping portions 110. In some embodiments, the locking member 400 includes a base 494. The first half 491 and the second half 492 are spaced apart from each other on the base 494. The space between the first half 491 and the second half 492 is configured to accommodate the locked portions 130 of at least two clamping portions 110, allowing the locked portions 130 to engage with the second locking grooves 493. In some embodiments, the second locking grooves 493 include, but are not limited to, recessed grooves or through grooves.

[0330] In some embodiments, the surface of the base 494 facing the inner wall of the sheath tube 210 includes two flat surfaces 4941 and two curved surfaces 4942. The two flat surfaces are located on opposite sides of the base 494, and the two curved surfaces are located on other opposite sides of the base 494. When the locking member 400 is engaged with the sheath tube 210, a gap is formed between the two flat surfaces and the sheath tube 210, forming a passage for the extension portion 120 to pass through. The two curved surfaces are in contact with the inner wall of the sheath tube 210, allowing the sheath tube 210 to limit the locking member 400 and prevent it from shaking.

[0331] In some embodiments, the suspended portion of the interlocking piece constitutes the locked portion 130, and the distal surface of the locked portion 130 is perpendicular to the second direction, where the second direction can be the direction indicated by arrow D2 in Figure 77, or can also be understood as the length direction of the clamping portion 110. In this way, when the locking member 400 and the clamping portion 110 tend to separate, the force between the distal surface of the locked portion 130 and the second locking groove 493 is in the second direction. Since the locked portion 130 is configured to be subjected to force in the second direction without deformation, the locking member 400 and the clamping portion 110 will not separate, thereby improving locking stability.

[0332] In some embodiments, when at least two clamping portions 110 cooperate with the locking member 400, at least a portion of the interlocking structure 112 of each clamping portion 110 is located between the first half 491 and the second half 492 of the locking member 400, and the locked portions 130 of the two interlocking plates of each interlocking structure 112 are respectively inserted into the second locking groove 493 of the first half 491 and the second locking groove 493 of the second half 492, so that at least two clamping portions 110 are locked with the locking member 400.

[0333] In some embodiments, the locked portion 130 is provided with an actuation ramp 116, which is arranged toward the proximal end of the clamping portion 110. The locking member 400 includes a contact portion 440, which is configured to cooperate with the actuation ramp 116 and guide the locked portion 130 into the second locking groove 493. In some embodiments, the distal ends of the first and second halves 491 and 492 form an inclined surface, which serves as the contact portion 440. In some embodiments, when the contact portion 440 cooperates with the actuation ramp 116, it can actuate the two interlocking plates to elastically deform in a first direction, causing the two locked portions 130 to approach each other and enter the gap between the first and second halves 491 and 492. When the actuation ramp 116 passes over the contact portion 440, the two interlocking plates resume their elastic deformation, causing the locked portion 130 to spring back into the second locking groove 493, resulting in a positional lock. For more exemplary embodiments of the actuation ramp 116 and the contact portion 440, please refer to the relevant description in the first embodiment.

[0334] FIG82 is an exemplary structural diagram of the distal end of the sheath tube 210 according to some embodiments of the present specification. FIG83 is a partial cross-sectional view of the distal end of the sheath tube 210 according to some embodiments of FIG82. FIG84 is an axial view of the distal end of the sheath tube 210 according to some embodiments of FIG82. FIG85 is an exemplary structural diagram of the locking member 400 engaged with the sheath tube 210 according to some embodiments of the present specification. FIG86 is a cross-sectional view of the locking member 400 engaged with the sheath tube 210 according to some embodiments of FIG85. FIG87 is an axial view of the locking member 400 engaged with the sheath tube 210 according to some embodiments of FIG85.

[0335] As shown in FIG. 79 and FIG. 82 to FIG. 87 , in some embodiments, the sheath tube 210 includes at least one retaining structure 211 , and the retaining structure 211 is used to limit the locking member 400 within the channel of the sheath tube 210 .

[0336] In some embodiments, the sheath 210 includes a first retaining structure 211-1, and the locking member 400 includes a first mating portion 450. The first retaining structure 211-1 cooperates with the first mating portion 450 to limit the movement and rotational movement of the locking member 400 from the distal end to the proximal end relative to the sheath 210, thereby maintaining the locking member 400 in a desired position, such as the distal end of the sheath 210. For an exemplary embodiment of the first retaining structure, see the description of Example 3.

[0337] In some embodiments, radially protruding steps are formed at the junctions between the first half 491 and the second half 492 of the locking member 400 and the base 494, respectively, and the steps constitute the first mating portion 450. In some embodiments, the first retaining structure 211-1 includes a U-shaped stepped surface, and the step of the first mating portion 450 can adapt to the U-shaped stepped surface, thereby limiting the proximal movement and rotational movement of the first mating portion 450.

[0338] In some embodiments, the sheath 210 includes a second retaining structure 211-2, and the locking member 400 includes a second mating portion 460. The second retaining structure 211-2 and the second mating portion 460 are releasably connected to each other to limit the movement of the locking member 400 from the proximal end to the distal end relative to the sheath 210. After the locking member 400 locks at least two clamping portions 110, the second retaining structure 211-2 separates from the second mating portion 460, and the locking member 400 is released from the sheath 210.

[0339] In some embodiments, the second retaining structure 211-2 includes at least one retaining spring, the proximal end of which is connected to the inner wall of the sheath 210 and the distal end of which protrudes radially inward from the inner wall of the sheath 210. The distal surfaces of the first half 491 and the second half 492 constitute a retaining surface (i.e., the second mating portion 460), and the distal end of the retaining spring is releasably connected to the retaining surface. In some embodiments, the retaining spring is formed by cutting from the sidewall of the sheath 210 and has a certain width along the circumferential direction to increase the contact area between the distal end of the retaining spring and the retaining surface of the locking member 400, thereby improving the stability of the locking member 400 within the sheath 210. In some embodiments, the second retaining structure 211-2 includes a first retaining spring and a second retaining spring. The first retaining spring is releasably connected to the distal surface of the first half 491, and the second retaining spring is releasably connected to the distal surface of the second half 492.

[0340] As shown in FIG. 77 , in some embodiments, the clamp arm 100 includes an actuating portion 135. The actuating portion 135 is configured to actuate the release of the second retaining structure 211-2 and the second mating portion 460 when moving from the distal end to the proximal end, thereby releasing the locking member 400 from the sheath 210. The actuating portion 135 refers to a component or portion that can directly or indirectly cause the release of the second retaining structure 211-2 and the second mating portion 460. Providing the actuating portion 135 to actuate the release of the locking member 400 from the sheath 210 prevents other components or portions from disturbing the locking member 400 during movement, thereby reducing the risk of accidental release of the locking member 400.

[0341] In some embodiments, the resisting structure 211 includes a response portion 2111, which is configured to drive the resisting structure 211 to disengage from the locking member 400 under a preset condition, thereby releasing the locking member 400 from the sheath 210. In some embodiments, the actuator 135 is configured to contact the response portion 2111 when moving from the distal end to the proximal end, causing the response portion 2111 to meet a preset condition. In some embodiments, the preset condition includes, but is not limited to, the response portion 2111 being subjected to a force in the radial direction of the sheath 210 that is greater than a second preset force value.

[0342] In some embodiments, the response portion 2111 is provided on the second resisting structure 211-2 and protrudes from the second resisting structure 211-2 radially inwardly of the sheath tube 210. In some embodiments, the response portion 2111 is provided on the second resisting structure 211-2 and protrudes from the second resisting structure 211-2 radially inwardly of the sheath tube 210. In some embodiments, the distal end of each limiting spring piece is provided with two tooth-shaped protrusions, and the tooth-shaped protrusions include an inclined surface for cooperating with the actuating portion 135. When the actuating portion 135 moves from the distal end to the proximal end and approaches the limiting spring piece, the actuating portion 135 squeezes the inclined surface of the tooth-shaped protrusion and generates a force on the tooth-shaped protrusion along the radial direction of the sheath tube 210 and greater than the second preset force value, so that the distal end of the limiting spring piece is deformed radially outwardly along the sheath tube 210, the second resisting structure 211-2 is disengaged from the second cooperating portion 460, and the locking member 400 is released from the sheath tube 210. By providing the tooth-shaped protrusion, the actuating portion 135 can more easily expand the limiting spring piece in the radial direction.

[0343] In some embodiments, the actuating portion 135 is disposed on the locked portion 130 . For example, the actuating portion 135 is disposed on the interlocking structure 112 of the locked portion 130 , and at least part of the fixed portion of the interlocking plate of the interlocking structure 112 constitutes the actuating portion 135 to improve the strength of the actuating portion 135 .

[0344] Figures 88 to 92 are schematic diagrams of the operation process according to some embodiments of this specification. The figures only show the locked state, the pre-release state, and the release state of the extension portion 120 and the clamping portion 110. For other states, please refer to Figures 67 to 76 of the third embodiment.

[0345] As shown in Figures 88 and 89, the clamping portion 110 is in a pre-locking state, and the extension portion 120 drives the interlocking structure 112 of the clamping portion 110 to approach the locking member 400. When the actuating slope 116 of the interlocking structure 112 abuts against the contact portion 440 of the locking member 400, and generates feedback resistance to prevent the clamping portion 110 from moving from the distal end to the proximal end, the feedback resistance is fed back to the operator through the core shaft 220, prompting the operator that the clamping portion 110 is about to enter the locking state.

[0346] As shown in FIG. 90 , the clamping portion 110 enters the locking state from the pre-locking state, and the locking member 400 and the sheath tube 210 are released.

[0347] The process of the clamping portion 110 transitioning from the pre-locking state to the locked state is as follows: the extension portion 120 drives the clamping portion 110 to continue moving from the distal end to the proximal end. In the pre-locking state, the actuating ramp 116 abuts the contact portion 440. The force exerted by the contact portion 440 on the two interlocking pieces causes the locked portion 130 to move closer together, entering the gap between the first half 491 and the second half 492. When the actuating ramp 116 passes over the contact portion 440, the two interlocking pieces return to their original shape, the locked portion 130 engages with the second locking groove 493, and the clamping portion 110 is locked to the locking member 400.

[0348] The process of releasing the locking member 400 from the sheath 210 is as follows: when the clamping portion 110 is in the pre-locking state, the extension portion 120 drives the clamping portion 110 to move from the distal end to the proximal end, and the actuating portion 135 of the interlocking structure 112 actuates the responding portion 2111 of the second resisting structure 211-2, causing the second resisting structure 211-2 to deform radially outward relative to the sheath 210, so that the second resisting structure 211-2 and the second mating portion 460 of the locking member 400 are disengaged, and the locking member 400 is released from the sheath 210.

[0349] As shown in Figures 91 and 92, the extension portion and the clamping portion are released. In some embodiments, the extension portion 120 continues to move from the distal end to the proximal end, and the second abutting portion 212 of the sheath 210 abuts the trigger portion 121, causing the trigger portion 121 to trigger the second connecting structure 122 of the extension portion 120 to break, deform, or displace, thereby releasing the second connecting structure 122 from the interlocking structure 112. At this point, the extension portion 120 and the clamping portion 110 are released. Specifically, after the distal end surface of the first tubular member 213 contacts the inclined surface at the proximal end of the elastic support arm of the extension portion 120, the force exerted by the end surface on the inclined surface causes the two elastic support arms to deform and move closer together, causing the connecting recess 1221 on the elastic support arm to disengage from the connecting groove 113 of the interlocking structure 112, and the extension portion 120 and the clamping portion 110 are released. Subsequently, the clamping portion 110 and the locking member 400 are released from the sheath 210. At least two clamping parts and the locking member remain locked, and the entire assembly is released from the sheath passage, remaining at the tissue wound to assist in closing the tissue wound, while the sheath and extension 120 and other components are withdrawn from the body.

[0350] Embodiment 3 of this specification provides an operating method of a clamp instrument 10 , which is applicable to the clamp instrument 10 shown in any of the above embodiments.

[0351] 93 is an exemplary flow chart of an operating method of the clip instrument 10 according to some embodiments of the present specification. This operating method can be applied to the clip instrument 10 in any of the above embodiments.

[0352] As shown in FIG93 , in some embodiments, the method of operating the clip instrument 10 includes a process 9300. In some embodiments, the process 9300 can be performed by an operating unit and includes the following steps:

[0353] Step 9310: Control at least two clamping parts 110 of the clamping arm 100 to open.

[0354] In some embodiments, the operating part controls the core shaft 220 to move from the proximal end to the distal end, and the core shaft 220 drives the extension part 120 and the clamping part 110 to move from the proximal end to the distal end, so that the distal end of the extension part 120 extends out of the sheath tube 210 channel, and at least two clamping parts 110 move away from each other and are in an open state, and a clamping space 20 for clamping tissue is formed between at least two clamping parts 110.

[0355] Step 9320 , controlling at least two clamping parts 110 of the clamping arm 100 to close.

[0356] In some embodiments, the operating part controls the core shaft 220 to move from the distal end to the proximal end, and the core shaft 220 drives the extension part 120 and the clamping part 110 to move from the distal end to the proximal end, so that the distal end of the extension part 120 is retracted into the sheath tube 210 channel, and at least two clamping parts 110 are close to each other in a closed state, and the tissue is clamped between at least two clamping parts 110.

[0357] In some embodiments, at least a portion of the extension portion 120 is located within the channel of the sheath 210 , while the clamping portion 110 remains outside the channel of the sheath 210 to facilitate clamping of tissue.

[0358] In step 9330, the clamp arm 100 is controlled to move from the distal end to the proximal end, and at least two clamping parts 110 cooperate with the locking member 400 to lock the at least two clamping parts 110; wherein, when the clamp arm 100 moves from the distal end to the proximal end, at least two clamping parts 110 actuate the locking member 400 and the sheath 210 to release.

[0359] In some embodiments, before the at least two clamping portions 110 are locked, the method for operating the clamp instrument further includes a pre-locking step: the operating portion 300 controls the clamping portion 110 to abut against the distal end of the locking member 400, causing the locking member 400 to generate feedback resistance against the clamping portion 110, thereby pre-locking the clamping portion 110 and the locking member 400. In some embodiments, in the pre-locking state, the clamping portion 110 of the clamp arm 100 includes a second limiting structure 134, which abuts against the contact portion 440 of the locking member 400 and generates feedback resistance that prevents the clamping portion 110 from moving from the distal end to the proximal end. In some embodiments, the second limiting structure 134 includes a locking spring. During the movement of the clamp arm 100 from the distal end to the proximal end, the distal bent portion of the locking spring abuts against the contact portion 440 of the locking member 400 before entering the accommodating cavity 410. The contact portion 440 then generates feedback resistance on the locking spring. This feedback resistance is fed back to the operator via the core shaft 220, prompting the operator that the clamping portion 110 is about to enter the locked state. In other embodiments, the actuating inclined surface 116 of the control interlocking structure 112 abuts against the contact portion 440 of the locking member 400 and generates feedback resistance that prevents the clamping portion 110 from moving from the distal end to the proximal end. This feedback resistance is fed back to the operator via the core shaft 220, prompting the operator that the clamping portion 110 is about to enter the locked state.

[0360] In some embodiments, after the operator feels the feedback resistance, the operator can reconfirm the clamping of the tissue by the clamping portion 110. If the clamping portion 110 does not clamp the tissue normally, the operator pushes the core shaft 220 from the proximal end to the distal end, so that the clamping portion 110 changes from a closed state to an open state and re-clamps the tissue. In some embodiments, if the clamping portion 110 clamps the tissue normally, the operator pulls the core shaft 220 from the distal end to the proximal end, so that the locking spring is deformed by the force, and the bent portion passes over the contact portion 440 and enters the accommodating cavity 410 to cooperate with the locking recess, and the clamping portion 110 enters the final locking state. In other embodiments, if the clamping portion 110 clamps the tissue normally, the operator pulls the core shaft 220 from the distal end to the proximal end, so that the actuating inclined surface 116 passes over the locking protrusion 473, and the locking protrusion 473 enters the locking groove 115, and the clamping portion 110 enters the final locking state. By providing the contact portion 440 and the second stop structure 430 to form a feedback resistance, the operator can be prompted to confirm the tissue clamping status before locking, thereby reducing surgical errors.

[0361] In some embodiments, the operating unit controls the first limiting structures 133 of at least two clamping portions 110 to cooperate with the first stop structure 420 of the locking member 400 to limit relative movement between the clamping portion 110 and the locking member 400 in a first direction. In some embodiments, this includes the direction indicated by arrow D1 in FIG. 13 , such as the width direction of the clamping portion 110 .

[0362] In some embodiments, the operating unit controls the second limiting structures 134 of at least two clamping portions 110 to cooperate with the second stop structure 430 of the locking member 400 to limit relative movement between the clamping portions 110 and the locking member 400 in a second direction, wherein the second direction is non-parallel to the first direction. In some embodiments, this includes the direction indicated by arrow D2 in FIG. 13 , such as the longitudinal direction of the clamping portion 110. In some embodiments, after the clamping portion 110 and the locking member 400 are pre-locked, the operating unit controls the mandrel 220 to move from the distal end to the proximal end, and the mandrel 220 drives the clamping portion 110 to continue moving from the distal end to the proximal end. The second limiting structure 134 of the clamping portion 110 passes over the contact portion 440 and cooperates with the second stop structure 430 of the locking member 400. The first limiting structure 133 of the locked portion 130 cooperates with the first stop structure 420 of the locking member 400, thereby locking the at least two clamping portions 110.

[0363] In some embodiments, the locking member 400 includes a third stop structure, and the accommodating cavity 410 of the locking member 400 constitutes the third stop structure; the locked portion 130 includes a third limiting structure, and the third limiting structure is arranged on the side of the clamping portion 110 facing the clamping space 20, and the suspension portion 132 constitutes the third limiting structure; when the clamping portion 110 is in a closed state, the third limiting structure is located in the accommodating cavity 410, and the movement of at least two clamping portions 110 in the direction of moving away from each other and / or in the direction of relative rotation is restricted.

[0364] In some embodiments, the operating unit controls the actuating portion 135 of the clamping portion 110 to actuate the second resisting structure 211-2 of the sheath 210 and the second mating portion 460 of the locking member 400 to release; wherein, the second resisting structure 211-2 and the second mating portion 460 are releasably connected to limit the movement of the locking member 400 from the proximal end to the distal end relative to the sheath 210.

[0365] In some embodiments, the sheath 210 or the rotating section 240 of the sheath 210 is an integrally formed structure. In some embodiments, the operating unit controls the clamping portion 110 to move from the distal end to the proximal end, and the actuating portion 135 of the clamping portion 110 moves to the proximal end of the second retaining structure 211-2 of the sheath 210, expanding the proximal end of the second retaining structure 211-2 until it releases the second mating portion 460 of the locking member 400, thereby releasing the locking member 400 from the sheath 210.

[0366] In some embodiments, the sheath tube 210 or the rotating section 240 of the sheath tube 210 includes a first tube 213 and a second tube 214, which are axially movably connected. In some embodiments, the operating unit controls the clamping portion 110 to move from the distal end to the proximal end, and the actuating portion 135 at the proximal end of the clamping portion 110 abuts against the distal end surface of the second tube 214. The actuating portion 135 is controlled to continue to move from the distal end to the proximal end and push the second tube 214 to move from the distal end to the proximal end relative to the first tube 213, causing the second retaining structure 211-2 of the sheath tube 210 to deform, displace, or break under force, thereby releasing it from the second mating portion 460 of the locking member 400. At this time, the locking member 400 is released from the sheath tube 210.

[0367] In some embodiments, the operating part controls the locking of the at least two clamping parts and the locking part before, simultaneously with, or after the locking part and the sheath are released.

[0368] In some embodiments, the second retaining structure 211-2 of the sheath tube 210 is positioned so that, before the at least two clamping portions 110 engage with the locking member 400, the actuating portion 135 actuates the second retaining structure 211-2 to deform, displace, or break, separating it from the locking member 400. In some embodiments, the operating portion first controls the locking member 400 to separate from the sheath tube 210, placing the locking member 400 in a separated state; then, the operating portion controls the at least two clamping portions 110 to lock with the separated locking member 400.

[0369] In some embodiments, the second resisting structure 211-2 is positioned so that, when the at least two clamping portions 110 engage with the locking member 400, the actuating portion 135 causes the second resisting structure 211-2 to deform, displace, or break, separating from the locking member 400. In some embodiments, the operating portion simultaneously controls the locking member 400 to separate from the sheath 210 and lock the at least two clamping portions 110 with the locking member 400.

[0370] In some embodiments, the second retaining structure 211-2 is positioned so that, after the at least two clamping portions 110 engage with the locking member 400, the actuating portion 135 causes the second retaining structure 211-2 to deform, displace, or break, separating from the locking member 400. In some embodiments, the operating portion controls the at least two clamping portions 110 to engage with the locking member 400, locking the at least two clamping portions 110. Subsequently, the operating portion controls the locking member 400 to separate from the sheath tube 210.

[0371] In some other embodiments, when the clamping portion 110 is in the pre-locking state, the operating portion controls the locking member 400 to release from the sheath tube 210. For example, the operating portion continues to control the extension portion 120 to move from the distal end to the proximal end, and the extension portion 120 drives the clamping portion 110 to move from the distal end to the proximal end. The actuating portion 135 of the interlocking structure 112 actuates the responding portion 2111 of the second resisting structure 211, causing the second resisting structure 211 to deform radially outward relative to the sheath tube 210, thereby disengaging the second resisting structure 211 from the second mating portion 460 of the locking member 400, and the locking member 400 is released from the sheath tube 210.

[0372] In some other embodiments, after the locking member 400 is released from the sheath 210, the operating unit controls the clamping portion 110 and the locking member 400 to lock the clamping portion 110 and the locking member 400. For example, the operating unit controls the core shaft 220 to move from the distal end to the proximal end, the core shaft 220 drives the clamping portion 110 to continue to move from the distal end to the proximal end, and the extension portion 120 drives the clamping portion 110 to continue to move from the distal end to the proximal end. The actuating inclined surface 116 of the interlocking structure 112 abuts against the contact portion and generates an interaction force, causing the interlocking structure 112 to elastically deform in the first direction. The locking portion 130 of the stop structure interlocking structure 112 of the locking member 400 cooperates, causing the locking protrusion to pass over the actuating inclined surface 116 and enter the locking groove, thereby locking at least two clamping portions 110 and the locking member 400.

[0373] Step 9340 , controlling at least two clamping parts 110 to release from the sheath tube 210 .

[0374] In some embodiments, the operating part controls the extension part 120 to release from the clamping part 110 , and then controls the extension part 120 to retract the sheath, so that the clamping part 110 and the locking element 400 are released from the sheath together.

[0375] In some embodiments, the operating part controls the extension part 120 of the clamp arm 100 to move from the distal end to the proximal end, so that the trigger part 121 of the extension part 120 or the clamping part 110 abuts against the abutment part 212 of the sheath 210, and the abutment part 212 can generate a squeezing force on the trigger part 121.

[0376] In some embodiments, the operating portion controls the extension portion 120 to continue moving from the distal end to the proximal end, and the trigger portion 121 is subjected to a force in a first direction, causing the first connection structure 111 (or interlocking structure 112) of the clamping portion 110 to separate from the second connection structure 122 of the extension portion 120, thereby releasing the extension portion 120 from the clamping portion 110; wherein the first direction is non-parallel to the movement direction of the extension portion 120. In some embodiments, the first direction is perpendicular to the movement direction of the extension portion 120 or forms another angle.

[0377] In some embodiments, the operating unit controls the extension portion 120 to withdraw the sheath 210, releasing the at least two clamping portions 110 and the locking member 400 from the sheath 210. The at least two clamping portions 110 and the locking member 400 are then released from the sheath 210. The at least two clamping portions and the locking member remain locked, detaching from the sheath channel as a whole and remaining within the tissue wound, assisting in wound closure. The sheath, extension portion 120, and other components are then withdrawn from the body.

[0378] The beneficial effects that may be brought about by the embodiments of the present application include but are not limited to:

[0379] (1) The locking piece is arranged in the sheath channel, which reduces the size of the locking piece, and the size of the locking piece after being matched with the clamping part is also smaller.

[0380] (2) The locking piece is arranged on the inner side of the clamping part. Compared with the traditional clamping part, the retention length of the locking piece and the clamping part can be reduced by 30% to 70%, which effectively improves the operating field of the operation and reduces the difficulty of the operation.

[0381] (3) The locking member is arranged on the inner side of the extension portion, which solves the problem of the limited opening angle of the extension portion. That is, the opening angle of the extension portion is not limited by the locking member, so that the clamping portion obtains a larger clamping space.

[0382] (4) By providing an interlocking structure that cooperates with the extension and the locking member, the connection and locking functions are integrated into the interlocking structure, making the overall structure more compact and the clamping portion smaller in size. The small-sized locking member and clamping portion are less likely to be disturbed by the environment in the narrow space inside the body, thereby preventing the clamping portion from accidentally separating due to external forces;

[0383] (5) The locked portion is arranged on the side of the clamping portion facing the clamping space, that is, the locking member locks the locked portion on the inner side of at least two clamping portions, and does not occupy the space outside the clamping portions, so that the structure of the clamping portions is more compact and small after closing, thereby reducing the surgical field of view blocked by the clamping portions.

[0384] (6) The locking member cooperates with the sheath through a resisting structure. When the clamping part performs an opening or closing operation, the clamping part and the locking member do not contact each other, and the movement of the clamping part or other components (such as the extension part, etc.) will not affect the connection stability of the locking member.

[0385] (7) By providing a rotating section so that the clamp arm can rotate around the axis of the sheath tube, the closing direction of at least two clamping parts can be adjusted more conveniently to be consistent with the closing direction of the tissue wound, thereby improving the accuracy of clamping the tissue wound.

[0386] (8) By providing a contact portion and a second stop structure to form a feedback resistance, the operator can be prompted to confirm the tissue clamping status before locking, thereby reducing surgical errors.

[0387] (9) By providing an actuating portion to actuate the locking member to release from the sheath, it is possible to prevent other components or parts from disturbing the locking member during movement, thereby reducing the risk of accidental release of the locking member.

[0388] (10) By providing a trigger portion, the extension portion can be released from the clamping portion only when it is triggered by the trigger portion, thereby avoiding accidental detachment of the extension portion and the clamping portion due to the pulling force between the extension portion and the clamping portion along the direction of movement, thereby reducing surgical risks.

[0389] (11) The locked portion is configured so that it will not deform even if a force is applied in the second direction, so that the stop structure cannot be separated from the locked portion, and the locking member and the clamping portion remain in a mating state, which can improve the mating reliability and stability of the locking member and the clamping portion, and enhance the ability of the clamping portion and the locking member to resist external force disturbances.

[0390] (12) By providing a response portion, the locking member is released only when a preset condition is met, thereby avoiding accidental release and improving the safety of the clamp device.

[0391] It should be noted that different embodiments may produce different beneficial effects. In different embodiments, the beneficial effects that may be produced may be any one or a combination of the above, or any other possible beneficial effects.

[0392] While the basic concepts have been described above, it will be apparent to those skilled in the art that the detailed disclosure is merely illustrative and does not limit this specification. Although not explicitly stated herein, various modifications, improvements, and revisions to this specification may be made by those skilled in the art. Such modifications, improvements, and revisions are suggested in this specification and remain within the spirit and scope of the exemplary embodiments of this specification.

[0393] This specification also uses specific terms to describe the embodiments of this specification. For example, "one embodiment," "an embodiment," and / or "some embodiments" refer to a feature, structure, or characteristic associated with at least one embodiment of this specification. Therefore, it should be emphasized and noted that references to "one embodiment," "an embodiment," or "an alternative embodiment" two or more times in different locations in this specification do not necessarily refer to the same embodiment. Furthermore, certain features, structures, or characteristics of one or more embodiments of this specification may be appropriately combined.

[0394] Similarly, it should be noted that, in order to simplify the description of this specification and facilitate understanding of one or more embodiments, the foregoing description of the embodiments of this specification sometimes combines multiple features into a single embodiment, figure, or description thereof. However, this disclosure method does not mean that the subject matter of this specification requires more features than those recited in the claims. In fact, the features of an embodiment may be fewer than all the features of the individual embodiments disclosed above.

[0395] In some embodiments, numbers are used to describe the quantity of components and attributes. It should be understood that such numbers used in the description of the embodiments are modified by the modifiers "about", "approximately" or "substantially" in some examples. Unless otherwise stated, "about", "approximately" or "substantially" indicate that the numbers are allowed to vary by ±20%. Accordingly, in some embodiments, the numerical parameters used in the description and claims are approximate values, which may change according to the required characteristics of individual embodiments. In some embodiments, the numerical parameters should take into account the specified significant digits and adopt the general method of retaining digits. Although the numerical domains and parameters used to confirm the breadth of their range in some embodiments of this specification are approximate values, in specific embodiments, the settings of such numerical values ​​are as accurate as possible within the feasible range.

[0396] Finally, it should be understood that the embodiments described in this specification are intended only to illustrate the principles of the embodiments of this specification. Other variations may also fall within the scope of this specification. Therefore, by way of example and not limitation, alternative configurations of the embodiments of this specification may be considered consistent with the teachings of this specification. Accordingly, the embodiments of this specification are not limited to the embodiments explicitly described and illustrated in this specification.

Claims

1. A clamp device, characterized in that: include: a clamping arm comprising at least two clamping portions and at least two extension portions, wherein the clamping portions are releasably disposed at distal ends of the extension portions; a sheath, the sheath comprising a channel; A locking piece is releasably disposed in the channel of the sheath tube. When the locking piece cooperates with the at least two clamping parts, the at least two clamping parts are in a locked state.

2. The clip device according to claim 1, wherein: In the locked state, the locking member is located between the at least two clamping portions.

3. The clip device according to claim 1, wherein: The clamping arm includes at least two extensions, and the clamping portion is releasably arranged at the distal end of the extension; when the clamping portion is in an open state, the locking member is located between the at least two extensions.

4. The clip device according to claim 3, wherein: The clamping portion also has a closed state and a released state: In the open state, the at least two clamping parts are away from each other, a preset distance is maintained between the proximal end of the clamping part and the distal end of the sheath tube, and the locking member is axially limitedly disposed in the sheath tube channel; In the closed state, the at least two clamping parts are close to each other, the distal end of the locking member is located between the clamping parts, and the at least two clamping parts are located outside the sheath channel; In the locked state, the at least two clamping parts are locked with the locking member, the locking member is located between the clamping parts, and the proximal ends of the at least two clamping parts are located in the sheath channel; In the released state, the locking member is released from the sheath tube, and both the locking member and the clamping portion are located outside the sheath tube channel.

5. The clip device according to claim 4, wherein: The at least two clamping parts further have a pre-release state, the pre-release state being achieved before, simultaneously with, or after the locking state and before the release state; In the pre-release state: the extension portion is connected to the clamping portion, the locking member is disengaged from the sheath tube, the clamping portion and the extension portion remain connected, and the locking member is located in the sheath tube channel.

6. The clip device according to claim 3, wherein: The clamping portion includes a first connection structure, and the distal end of the extension portion includes a second connection structure, and the first connection structure and the second connection structure are releasably connected.

7. The clip device according to claim 6, wherein: The first connecting structure or the second connecting structure includes a trigger portion, which is configured to trigger one of the first connecting structure and the second connecting structure to break, deform or displace and release from the other when subjected to a force in a first direction greater than or equal to a first preset force value; wherein the first direction is non-parallel to the movement direction of the extension portion.

8. The clip device according to claim 7, wherein: The distal end of the sheath or the locking member includes an abutment portion, the trigger portion contacts the abutment portion, and when the force of the abutment portion acting on the trigger portion reaches the first preset force value, the first connection structure and the second connection structure are released.

9. The clip device according to claim 1, wherein: A clamping space is formed between the at least two clamping parts, and a locked part is provided on one side of the clamping part facing the clamping space; when the locking member cooperates with the locked part, the at least two clamping parts are locked.

10. The clip device according to claim 9, wherein: The locked portion includes at least one limiting structure, and the locking member includes at least one stopping structure. When the limiting structure cooperates with the stopping structure, the relative movement between the clamping portion and the locking member is restricted.

11. The clip device according to claim 10, wherein: The locking member includes a third stop structure, and the third stop structure includes an accommodating cavity; The locked portion includes a third limiting structure, and the third limiting structure is provided on a side of the clamping portion facing the clamping space; When the clamping parts are in a closed state, the third limiting structure is located in the accommodating cavity, and the movement of the at least two clamping parts in a direction away from each other and / or in a direction of relative rotation is restricted.

12. The clip device according to claim 11, wherein The locked portion includes a fixed portion and a suspended portion, the fixed portion is connected to the side of the clamping portion, the suspended portion is connected to the fixed portion and is arranged with a gap with the inner surface of the clamping portion, and the suspended portion constitutes the third limiting structure.

13. The clip device according to claim 9, wherein: The locking member includes a contact portion at the distal end, and the clamping portion further includes a pre-locking state and a final locking state; In the pre-locking state, the locked portion abuts against the contact portion and generates a feedback resistance that prevents the clamping portion from moving from the distal end to the proximal end; In the final locking state, the locked portion passes over the contact portion to form a limited fit with the locking member, and the at least two clamping portions are locked.

14. The clip device according to claim 1, wherein: The clamping arm includes at least two extensions, and the clamping portion is releasably provided at the distal end of the extension; the clamping portion includes an interlocking structure, the interlocking structure is releasably connected to the extension, and the interlocking structure is operably matched with the locking member; as well as, When the interlocking structure cooperates with the locking member, the at least two clamping parts are in a locked state.

15. The clip device according to claim 14, wherein: The interlocking structure includes a first connecting structure and a locked portion, the extending portion includes a second connecting structure, the first connecting structure and the second connecting structure are releasably connected, and the locked portion is used to cooperate with the locking member.

16. The clip device of claim 1, wherein: The locking member includes a stop structure, the clamping part includes an interlocking structure, and the interlocking structure includes a locked part. When the locked part is subjected to a force greater than or equal to a third preset force value applied by the stop structure in a first direction, the locked part is elastically deformed. After the locked part moves to the locking position of the stop structure, the locking member is locked with the locked part, and when the locked part is subjected to a force applied by the stop structure in a second direction, the deformation of the locked part is restricted. The second direction is the relative movement direction of the stop structure and the locked part, and the first direction is not parallel to the second direction.

17. The clip device according to claim 16, wherein: The stop structure includes a guide pin and at least one locking protrusion, the guide pin is arranged along the second direction, and the locking protrusion protrudes from at least one side of the guide pin along the first direction.

18. The clip device of claim 17, wherein: The interlocking structure includes interlocking plates respectively located on both sides of the clamping part, and the interlocking plates include a fixing part connected to the side of the clamping part and a suspension part facing the central axis of the clamping part. A guide groove and a locking groove are formed between the two suspension parts, and the guide groove is adapted to the guide pin, and the locking groove is adapted to the locking protrusion.

19. The clip device of claim 16, wherein: The clamping portion includes a fixing ring, which is arranged on the distal side of the interlocking structure. The locking piece includes a limiting recess. When the clamping portion and the locking piece are locked, the fixing rings of the at least two clamping portions are both fitted into the limiting recess.

20. The clip device of claim 16, wherein: The locking member includes a first half and a second half arranged at an interval, the proximal end of the first half and the proximal end of the second half are connected through a base, and locking grooves are formed on the surfaces of the first half and the second half facing each other, and at least one of the locking grooves constitutes the stop structure.

21. The clip device of claim 20, wherein: The interlocking structure includes two interlocking pieces, each of which has a bent structure. The bent structure includes a fixed portion, a receiving portion, and a hanging portion. The fixed portion is connected to a side of the clamping portion. The receiving portion is respectively connected to the fixed portion and the hanging portion to form at least one opening, the opening is away from the central axis of the clamping portion, and the hanging portion constitutes the locked portion. A distal end surface of the locked portion is perpendicular to the second direction.

22. The clip device of claim 1, wherein: The sheath includes a resisting structure, which releasably limits the locking piece in the sheath channel. When the clamping portion is in an open state, a closed state, and a locked state, the locking piece cooperates with the resisting structure and is located in the sheath channel; when the clamping portion is in a released state, the locking piece is released from the resisting structure and is located outside the sheath channel.

23. The clip device of claim 22, wherein: The resisting structure includes a response portion, which is configured to disengage from the locking member by deformation, displacement or fracture when subjected to a force along the radial direction of the sheath tube that is greater than a second preset force value, and the locking member is released from the sheath tube.

24. The clip device of claim 22, wherein: At least one of the retaining structures protrudes radially inward from the inner wall of the sheath tube. When the at least one retaining structure is releasably engaged with the locking member, the axial movement of the locking member relative to the sheath tube and / or the rotation of the locking member relative to the sheath tube are restricted.

25. The clip device of claim 24, wherein: The resisting structure includes a second resisting structure, and the locking piece includes a second matching portion. When the second resisting structure and the second matching portion are releasably connected, the movement of the locking piece from the proximal end to the distal end relative to the sheath is restricted.

26. The clip device of claim 25, wherein: The second resisting structure includes at least one limiting spring piece, one end of which is connected to the inner wall of the sheath tube, and the other end protrudes radially inward from the inner wall of the sheath tube. The second matching part includes at least one limiting surface toward the distal end, and one end of the limiting spring piece protruding from the inner wall of the sheath tube is releasably connected to the limiting surface.

27. The clip device of claim 25, wherein: The clamping portion includes an actuating portion. When the force applied by the actuating portion to the second resisting structure from the distal end to the proximal end is greater than or equal to the second preset force value, the second resisting structure is actuated to deform, displace or break and release from the second mating portion, thereby releasing the locking member and the sheath.

28. The clip device of claim 25, wherein: The sheath tube includes a first tube and a second tube, the second tube is axially movably provided at the distal end of the first tube, and the second resisting structure is provided on the second tube; The clamping portion includes an actuating portion. When the actuating portion moves from the distal end to the proximal end until it contacts the second resisting structure, and when the force applied by the actuating portion to the second resisting structure is greater than or equal to the second preset force value, the second tube moves toward the proximal end and actuates the second resisting structure to deform, displace or break and release from the second mating portion.

29. The clip device of claim 1, wherein: The sheath tube includes a fixed section and a rotating section. The proximal end of the rotating section is rotatably connected to the distal end of the fixed section, and the rotating section is configured to be rotatable around the sheath tube axis.

30. A method for operating a clamp device, characterized in that: The operating method is applied to the clip instrument according to any one of claims 1 to 29, and the operating method comprises: Controlling at least two clamping parts of the clamping arm to open; Controlling the at least two clamping parts of the clamping arm to close; Controlling the clamp arm to move from the distal end to the proximal end until the at least two clamping parts cooperate with the locking member, so that the at least two clamping parts are locked; when the clamping part moves from the distal end to the proximal end until it contacts the locking member, the at least two clamping parts continue to move proximally, actuating the locking member to release from the sheath; The at least two clamping parts are controlled to be released from the sheath tube.

31. The method for operating the clip device according to claim 30, wherein: Before the at least two clamping parts are locked, the method further comprises: The clamping portion is controlled to abut against the distal end of the locking member, so that the locking member generates feedback resistance on the clamping portion, and the clamping portion and the locking member are pre-locked.

32. The method for operating the clip device according to claim 30, wherein: The at least two clamping parts actuating the locking element and the sheath to release include: When the force applied by the actuating portion to the second resisting structure reaches a second preset force value, the actuating second resisting structure is deformed, displaced or broken and released from the second mating portion of the locking member, so that the locking member is released from the sheath; wherein, the second resisting structure and the second mating portion are releasably connected to limit the movement of the locking member from the proximal end to the distal end relative to the sheath.

33. The method for operating the clip device according to claim 30, wherein: The operation method further includes: The at least two clamping parts are controlled to lock with the locking member before, simultaneously with, or after the locking member and the sheath are released.

34. The method for operating the clip device according to claim 30, wherein: Controlling the at least two clamping parts to release from the sheath tube comprises: Controlling the extension portion of the clamp arm to move from the distal end to the proximal end, so that the trigger portion of the extension portion or the clamp portion abuts against the abutment portion of the sheath tube; The extension portion is controlled to continue to move from the distal end to the proximal end, and when the trigger portion is subjected to a force in a first direction so as to separate the first connection structure of the clamping portion from the second connection structure of the extension portion, the extension portion and the clamping portion are released; wherein the first direction is non-parallel to the movement direction of the extension portion; The extending portion is controlled to withdraw the sheath tube so that the at least two clamping portions and the locking element are released outside the sheath tube channel.

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