Clamp instrument and operation method thereof

Abstract

The embodiment of the invention provides a clip instrument and an operation method thereof. The clip instrument comprises a conveying device and a clamping device, wherein the conveying device comprises a sheathing canal and a mandrel arranged in the sheathing canal; the clamp device comprises at least two clamping pieces and a storage tube, the storage tube is arranged at the far end of the sheath tube and comprises a locking part, the near ends of the clamping pieces are arranged in the storage tube in an axial moving mode and comprise locked parts, and the clamping pieces are connected with the mandrel in a releasable mode; the clamp device comprises an unlocked state, a locked state and a released state, in the unlocked state, the core shaft is connected with the clamping piece, and the locked part is not matched with the locking part; in the locking state, the core shaft is connected with the clamping piece, and the locked part is matched with the locking part; and in the release state, the core shaft and the clamping piece are released.

Description

Technical Field

[0001] The present specification relates to the field of medical devices, and in particular to a clamp device and an operating method thereof. Background Art

[0002] In minimally invasive surgery, endoscopic clip instruments (e.g., hemostatic clips) are mainly used to clamp human tissues to achieve the purpose of hemostasis and suturing. However, it is difficult for commonly used clip instruments to achieve an effective self-locking function, so additional operations by the doctor are required to ensure that the hemostatic clip can be stably locked in a closed state, which increases the complexity and difficulty of the surgery. Moreover, after the clip instrument is locked, its stability after locking is often insufficient, and it is easy to loosen, resulting in poor hemostasis or suturing failure, and may even cause secondary injuries to the patient. In addition, the clip instrument may drop fragments during operation. These residual fragments may not only cause the hemostatic clip head to be unable to be removed smoothly, but may also remain in the patient's body, posing a potential threat to the patient's health. Summary of the invention

[0003] One or more embodiments of the present specification provide a clip device, comprising: a delivery device, comprising a sheath and a core shaft disposed in the sheath, the distal end of the core shaft comprising a first connection portion; a clip device, comprising at least two clips, a receiving tube and a second connection portion, the receiving tube being disposed at the distal end of the sheath, the proximal end of the clip being axially movably disposed in the receiving tube, the clip comprising a blocking portion, the clip and the core shaft being releasably connected via the first connection portion and the second connection portion; a blocking portion, configured to control the state of the proximal end of the clip by acting radially on the blocking portion; wherein, The clamp device includes an unlocked state, a locked state and a released state: in the unlocked state, the blocking portion is configured to constrain the obstructed portion radially inwardly so that the radial gap between the proximal end of the clip and the receiving tube is within a preset range, and the first connecting portion is connected to the second connecting portion; in the locked state, the blocking portion and the obstructed portion are released from the constraint, so that the proximal end of the clip is deformed or displaced radially outwardly to cooperate with the receiving tube, and the first connecting portion is connected to the second connecting portion; in the released state, the first connecting portion and the second connecting portion are released from the connection.

[0004] One or more embodiments of the present specification also provide a clamp instrument, comprising: a conveying device, comprising a sheath and a core shaft arranged in the sheath, the distal end of the core shaft comprising a first connection part; a clamp device, comprising at least two clips, a storage tube and a second connection part, the storage tube being arranged at the distal end of the sheath, the clip and the core shaft being releasably connected via the first connection part and the second connection part, the clamp device comprising an unlocked state, a locked state and a released state; wherein, in the unlocked state, the first connection part and the second connection part constitute a first mating state, and the proximal end of the clip is axially movably arranged in the storage tube; in the locked state, the first connection part is deformed or displaced due to a first force, and constitutes a second mating state with the second connection part, and the proximal end of the clip is locked with the storage tube; in the released state, the first connection part is deformed or displaced due to a second force, and is released from the second connection part, and the core shaft is released from the clip.

[0005] One or more embodiments of the present specification also provide an operating method for a clamp instrument, the operating method being applied to the clamp instrument as described in any of the above embodiments, the clamp instrument comprising a blocking portion, the clip comprising a blocked portion, the operating method comprising: controlling the radial gap between the proximal end of the clip and the receiving tube within a preset range by means of the blocking portion, the first connection portion of the core shaft and the second connection portion of the clamp device having a first mating state, operating the core shaft to reciprocate along the sheath channel to drive the clip to open or close; operating the core shaft to move from the distal end to the proximal end to switch the first connection portion and the second connection portion to a second mating state, thereby triggering the blocking portion and the blocked portion to release the constraints, so that the proximal end of the clip is deformed or displaced radially outward to cooperate with the receiving tube, and the clamp device is locked; operating the core shaft to continue to move from the distal end to the proximal end to release the first connection portion and the second connection portion, and the clamp device is released.

[0006] When the blocking portion cooperates with the obstructed portion, the two clips can be opened or closed freely. When the blocking portion is released from the obstructed portion, the proximal ends of the two clips can be deformed or displaced radially outward and locked with the receiving tube. The entire locking process occurs due to the automatic deformation of the proximal ends of the clips, which reduces the locking operation. After the proximal ends of the clips cooperate with the receiving tube, the receiving tube can limit the axial displacement and radial displacement of the proximal ends of the clips, thereby improving the locking stability of the clips. Before and when the clips are locked, the first connecting portion is connected to the second connecting portion. After the clips are locked, the first connecting portion is released from the second connecting portion, thereby making the operation more precise and reliable, reducing the possibility of misoperation, and improving the safety of surgical operations. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] This specification will be further described in the form of exemplary embodiments, which will be described in detail by the accompanying drawings. These embodiments are not restrictive, and in these embodiments, the same number represents the same structure, wherein:

[0008] Figure 1 is an exemplary structural diagram of a clip device according to some embodiments of the present specification;

[0009] Figure 2 is an exemplary structural diagram of the distal end structure of the clip device shown in some embodiments of this specification;

[0010] Figure 3 is based on Figure 2 A cross-sectional view of the clip device shown taken along line AA;

[0011] Figure 4 is based on Figure 2 An exploded view of the clip apparatus shown;

[0012] Figure 5 is an exemplary structural diagram of the distal end structure of the mandrel according to some embodiments of the present specification;

[0013] Figure 6 is based on Figure 5 A partial enlarged view of region B of the distal structure of the mandrel is shown;

[0014] Figure 7 is a partial enlarged view of the clip and the side wing after they are matched according to some embodiments of this specification;

[0015] Figure 8 is a side view of a distal end structure of a mandrel according to some embodiments of the present specification;

[0016] Fig. 9 is an exemplary structural diagram of a clip according to some embodiments of this specification;

[0017] Fig.10 is an exemplary structural diagram of a storage tube according to some embodiments of this specification;

[0018] Fig.11A is a front view of the distal end structure of the mandrel according to some embodiments of the present specification Figure 1 ;

[0019] Fig. 11B is a front view of the distal end structure of the mandrel according to some embodiments of the present specification Figure 2 ;

[0020] Fig. 12A is a cross-sectional view of a clip device in an unlocked state according to some embodiments of the present specification;

[0021] Fig. 12B is based on Fig. 12A A cross-sectional view of the clip device shown taken along line CC;

[0022] Fig.13A is a cross-sectional view of a clip device in a locked state according to some embodiments of the present specification;

[0023] Fig. 13B is based on Fig.13A A cross-sectional view of the clip device shown taken along line DD;

[0024] Fig.14 is a cross-sectional view of a first connection portion and a second connection portion in a released state according to some embodiments of the present specification;

[0025] Fig.15 is a cross-sectional view of a receiving tube and a sheath tube in a released state according to some embodiments of the present specification;

[0026] Fig.16 is an exemplary structural diagram of the distal end structure of the clip device shown in some embodiments of this specification;

[0027] Fig.17 is an exemplary structural diagram of a storage tube according to some embodiments of this specification;

[0028] Fig.18 is an exemplary structural diagram of the distal end structure of the mandrel according to some embodiments of the present specification;

[0029] Fig.19 is an exemplary structural diagram of a clip according to some embodiments of this specification;

[0030] Fig. 20 is a cross-sectional view of a clip device in an open state according to some embodiments of the present specification;

[0031] Fig.21 is a cross-sectional view of a clip device in a closed state according to some embodiments of the present specification;

[0032] Fig. 22 is a cross-sectional view of a clip device in a locked state according to some embodiments of the present specification;

[0033] Fig.23A is a cross-sectional view of a clip device in a released state according to some embodiments of the present specification Figure 1 ;

[0034] Fig. 23B is a cross-sectional view of a clip device in a released state according to some embodiments of the present specification Figure 2 ;

[0035] Fig.24 is an exemplary structural diagram of a storage tube according to some embodiments of this specification;

[0036] Fig.25 is an exemplary structural diagram of a clip according to some embodiments of this specification;

[0037] Fig.26 is a cross-sectional view of a clip device in an unlocked state according to some embodiments of the present specification;

[0038] Fig. 27 is a cross-sectional view of a clip device in a locked state according to some embodiments of the present specification;

[0039] Fig.28A is a schematic diagram of the structure of the clip device in a released state according to some embodiments of the present specification;

[0040] Fig.28B is based on Fig.28A A cross-sectional view of the clip device shown taken along line FF in region E;

[0041] Fig.28C is based on Fig.28B A cross-sectional view of the clip device shown taken along line GG;

[0042] Fig.29A is an exemplary isometric view of the distal end structure of the mandrel according to some embodiments of the present specification;

[0043] Fig.29B is based on Fig.29A An exemplary front view of the structure of the distal end of the mandrel is shown;

[0044] Fig.29C is based on Fig.29A An exemplary side view of the distal end structure of the mandrel is shown;

[0045] Fig. 30A is a mating state of the first connection portion and the second connection portion in an unlocked state according to some embodiments of this specification;

[0046] Fig. 30B is the mating state of the first connecting portion and the second connecting portion during the locking process according to some embodiments of this specification;

[0047] Fig. 30C is a mating state of the first connection portion and the second connection portion in a locked state according to some embodiments of this specification;

[0048] Fig.31Ais an exemplary structural diagram of a first predetermined form of a first connecting portion according to some embodiments of this specification;

[0049] Fig.31B is an exemplary structural diagram of a second predetermined form of a first connecting portion according to some embodiments of this specification;

[0050] Fig.32 is an exemplary structural diagram of a clip according to some embodiments of this specification;

[0051] Fig.33 is a cross-sectional view of a clip device in an unlocked state according to some embodiments of the present specification;

[0052] Fig.34 is a cross-sectional view of a clip device in a locked state according to some embodiments of the present specification;

[0053] Fig.35 is a cross-sectional view of a clip device in a released state according to some embodiments of the present specification;

[0054] Fig.36 is an exemplary structural diagram of the distal end structure of the clip device shown in some embodiments of this specification;

[0055] Fig.37 is an exemplary structural diagram of a storage tube according to some embodiments of this specification;

[0056] Fig.38 is an exemplary structural diagram of a storage tube according to some embodiments of this specification;

[0057] Fig.39 is an exemplary cross-sectional view of a distal end structure of a clip device according to some embodiments of the present specification;

[0058] Fig.40 is a flow chart of a method of operating a clip device according to some embodiments of the present specification;

[0059] The accompanying drawings are marked as follows:

[0060] 10. Clip device; 100. Clip device; 110. Clip; 111. Distal clamping portion; 112. Bending portion; 113. Proximal joint portion; 114. Assembly hole; 115. Locked portion; 116. Release hole; 120. Storage tube; 121. Limiting portion; 122. Main tube; 123. Tail tube; 124. First limiting hole; 125. Locking portion; 126. Slot; 127. Limiting structure; 130. Second connecting portion; 131. Connecting shaft; 132. Connecting hole; 140. Obstructed portion; 150. Matching portion; 200. Delivery device; 210. Sheath tube; 211. Second limiting hole; 220. Mandrel ; 221, first connecting part; 222, first limiting groove; 223, second limiting groove; 224, guide channel; 225, release port; 226, connecting hook; 227, actuating part; 2261, arm; 2262, hook; 2263, first limiting area; 2264, second limiting area; 2265, first barb; 2266, second barb; 230, connecting pin; 231, tube; 232, support arm; 240, spring end; 300, operating device; 400, blocking part; 410, flank; 411, main body; 412, pre-tightening part; 413, reinforcing rib; 414, welding point; 420, tube arm. DETAILED DESCRIPTION

[0061] In order to more clearly illustrate the technical solutions of the embodiments of this specification, the following is a brief introduction to the drawings required for the description of the embodiments. Obviously, the drawings described below are only some examples or embodiments of this specification. For ordinary technicians in this field, this specification can also be applied to other similar scenarios based on these drawings without creative work. Unless it is obvious from the language environment or otherwise explained, the same reference numerals in the figures represent the same structure or operation.

[0062] As shown in this specification and claims, unless the context clearly indicates an exception, the words "a", "an", "an" and / or "the" do not refer to the singular and may also include the plural. Generally speaking, the terms "comprise" and "include" only indicate the inclusion of the steps and elements that have been clearly identified, and these steps and elements do not constitute an exclusive list. The method or device may also include other steps or elements.

[0063] Flowcharts are used in this specification to illustrate the operations performed by the system according to the embodiments of this specification. It should be understood that the preceding or following operations are not necessarily performed precisely in order. Instead, the steps may be processed in reverse order or simultaneously. At the same time, other operations may also be added to these processes, or one or more operations may be removed from these processes.

[0064] Endoscopic clip instruments are widely used in minimally invasive surgery, which clamp tissue wounds to achieve the purpose of rapid suturing and hemostasis. Traditional clip instruments require doctors to directly apply operating force to the locking piece or clip to achieve locking, which has a certain degree of operating difficulty; in addition, the locking of the clip instrument is unstable and easy to loosen. During the operation, some structures are easy to break, resulting in debris, affecting the safety of the operation. In view of this, in some embodiments of the present specification, it is expected to provide a clip instrument, which realizes self-locking by configuring the proximal end of the clip to automatically pop open, thereby simplifying the operation; and strengthening the design of some easily deformed structures to improve the overall stability and reliability.

[0065] The technical solution of the clamp instrument will be explained below through multiple embodiments of this specification, aiming to improve the convenience and reliability of operation of the clamp instrument in clinical surgery through some improvement measures. First of all, it should be noted that various combinations and replacements can be made between different embodiments of this specification. For example, although some embodiments in this specification may only describe specific technical features, these features can be flexibly applied to other embodiments, or combined with features in other embodiments to obtain better results. Unless it is clearly stated that they cannot be replaced or combined, different embodiments of the present invention and their features can refer to and quote each other to form new embodiments.

[0066] First, this specification will introduce the technical solution of the clamp device in detail through Example 2.

[0067] Figure 1 is an exemplary structural diagram of a clip device according to some embodiments of the present specification.

[0068] like Figure 1 As shown, in some embodiments, the clip device 10 includes a clip device 100, a conveying device 200, and an operating device 300. The operating device 300 is disposed at the proximal end of the conveying device 200, and the clip device 100 is disposed at the distal end of the conveying device 200. The "proximal end" and "distal end" involved in the embodiments of this specification may indicate directions, which refer to the axial direction of the clip device 10 (for example, the extension direction of the sheath 210 of the conveying device 200 in 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 indicate partial structures located in the corresponding directions, and should not be understood as indicating only the ends.

[0069] In some embodiments, the delivery device 200 includes a sheath 210 and a core shaft 220 disposed in the sheath 210, the core shaft 220 extends axially along the sheath 210, the proximal end of the core shaft 220 is connected to the operating device 300, and the distal end of the core shaft 220 is connected to the clip device 100. The "axial" and "radial" involved in the embodiments of this specification can represent directions, and the "radial" direction is perpendicular to the "axial" direction, or the axial direction is the extension direction of the channel of the sheath 210, and the radial direction is perpendicular to the extension direction of the channel of the sheath 210. The user controls the axial movement of the operating device 300 in vitro and controls the axial movement of the core shaft 220 in the channel of the sheath 210, so that the clip device 100 completes the corresponding surgical operation, such as opening, closing, locking, releasing and other surgical operations.

[0070] Figure 2 is an exemplary structural diagram of the distal end structure of the clip instrument 10 shown in some embodiments of the present specification. Figure 3 is based on Figure 2 The clip instrument 10 is shown in cross-sectional view taken along line AA. Figure 4 is based on Figure 2 An exploded view of the clip instrument 10 is shown.

[0071] like Figures 2 to 4 As shown, the first embodiment of the present specification provides a clip instrument 10 , including a clip device 100 , a conveying device 200 and a blocking portion 400 .

[0072] In some embodiments, the distal end of the core shaft 220 of the delivery device 200 includes a first connection portion 221 , and the first connection portion 221 is used to connect to the clip device 100 , so that the core shaft 220 controls the movement of the clip device 100 through axial movement.

[0073] In some embodiments, the clip device 100 includes at least two clips 110, a storage tube 120, and a second connection portion 130. The storage tube 120 is disposed at the distal end of the sheath tube 210, and the proximal end of the clip 110 is axially movable in the storage tube 120. The clip 110 and the mandrel 220 are releasably connected through the first connection portion 221 and the second connection portion 130; the mandrel 220 controls the opening, closing, locking, and release of the clip 110 through axial movement. In some embodiments, the clip 110 includes an obstruction portion 140, which is disposed at the proximal end of the clip 110 or a position close to the proximal end.

[0074] In some embodiments, the blocking portion 400 is configured to control the state of the proximal end of the clip 110 by acting on the blocked portion 140 in a radial direction; wherein the state of the proximal end of the clip 110 includes a state where the proximal ends of the two clips 110 are close to each other and a state where the proximal ends of the two clips 110 are far from each other. In some embodiments, the blocking portion 400 is disposed at the distal end of the core shaft 220, for example, the blocking portion 400 includes but is not limited to the side wings 410 (such as Figure 5 As shown), tube arm 420 (as Fig.17 as shown) or connecting hook 226 (as shown Fig.31A and Fig.31B As shown in FIG. 1 , the side wing 410, the tube arm 420 or the connecting hook 226 can be released and matched with the obstruction part 140. In some other embodiments, the blocking part 400 is disposed on the inner wall of the storage tube 120, and the obstruction part 140 is in sliding contact with the blocking part 400 within a preset stroke range. A more detailed embodiment of the blocking part 400 will be described in detail in FIG. Figure 5 , Figure 6 , Figures 16 to 19 Described in.

[0075] In some embodiments, the clip device 100 includes an unlocked state, a locked state, and a released state:

[0076] In the unlocked state, the blocking portion 400 is configured to constrain the obstructed portion 140 radially inwardly, so that the radial gap between the proximal end of the clip 110 and the receiving tube 120 is within a preset range, and the proximal ends of the two clips 110 are close to each other and in a retracted state. The preset range can be set according to the internal structure and size of the receiving tube 120. For example, the preset range includes but is not limited to: greater than zero and less than or equal to 1 / 4 of the diameter of the receiving tube 120, etc. In addition, the first connecting portion 221 is connected to the second connecting portion 130, and the core shaft 220 can control the clip 110 to open and close repeatedly, and the clamping of the tissue can be flexibly adjusted in actual applications.

[0077] In the locked state, the blocking portion 400 and the blocked portion 140 are released from the constraints, so that the proximal end of the clip 110 is deformed or displaced radially outward to cooperate with the receiving tube 120, so that the proximal ends of the clip 110 are in an unfolded state away from each other, and the axial movement of the clip 110 relative to the receiving tube 120 is restricted, and the clip 110 is locked in the receiving tube 120. In addition, the first connecting portion 221 is connected to the second connecting portion 130. At this time, since the clip 110 is locked with the receiving tube 120, the core shaft 220 can no longer control the clip 110 to open.

[0078] In the released state, the first connection portion 221 is disconnected from the second connection portion 130 , and the core shaft 220 is released from the clip 110 .

[0079] In some embodiments, the unlocked state of the clip device 100 includes an open state and a closed state. In some embodiments, the clip 110 includes a distal clamping portion 111, a curved portion 112, and a proximal joint portion 113, the proximal joint portion 113 is movably disposed in the receiving tube 120, and the curved portion 112 is elastic. In the open state, when the core shaft 220 moves from the proximal end to the distal end, the proximal joint portion 113 pushes the curved portion 112 to extend out of the receiving tube 120, and the curved portion 112 is in a naturally curved state, so that the distal clamping portions 111 are separated from each other and opened; in the closed state, when the core shaft 220 moves from the distal end to the proximal end, the proximal joint portion 113 pulls the curved portion 112 back into the receiving tube 120, and the curved portion 112 is compressed by the receiving tube 120, so that the distal clamping portions 111 are close to each other and closed.

[0080] According to the clip instrument 10 in some of the above embodiments, when the blocking portion 400 cooperates with the obstructed portion 140, the two clips 110 can be opened or closed freely. When the blocking portion 400 is released from the obstructed portion 140, the proximal ends of the two clips 110 can be deformed or displaced radially outward and locked with the receiving tube 120. The entire locking process occurs by the automatic deformation of the proximal ends of the clips 110, which reduces the locking operation. After the proximal ends of the clips 110 cooperate with the receiving tube 120, the receiving tube 120 can limit the axial displacement and radial displacement of the proximal ends of the clips 110, thereby improving the locking stability of the clips 110. In addition, before and when the clips 110 are locked, the first connecting portion 221 is connected to the second connecting portion 130. After the clips 110 are locked, the first connecting portion 221 is released from the second connecting portion 130, making the operation more accurate and reliable, reducing the possibility of misoperation, and improving the safety of surgical operations.

[0081] like Figure 3 As shown, the first connection portion 221 is located between the proximal ends of at least two clips 110 to prevent the first connection portion 221 from interfering with the radial movement of the proximal ends of the clips 110 .

[0082] In some embodiments, the blocking portion 400 is disposed at the distal end of the mandrel 220, and the blocking portion 400 and the blocked portion 140 are released by axial relative displacement. In this way, the release timing of the blocking portion 400 and the blocked portion 140 can be accurately controlled by the axial movement of the mandrel 220, and the operation is simple and fast, ensuring that the clip device 100 is accurately released when needed, thereby improving the accuracy of the surgical operation.

[0083] In some embodiments, the storage tube 120 includes a limiting portion 121, and the clip device 100 includes a matching portion 150. When the clip 110 moves from the distal end to the proximal end, so that the matching portion 150 abuts against the limiting portion 121, the limiting portion 121 limits the clip 110 from moving from the distal end to the proximal end, and the core shaft 220 continues to move toward the proximal end, so that the blocking portion 400 and the obstructed portion 140 are axially relatively displaced. In some embodiments, the limiting portion 121 is provided at the proximal end or close to the proximal end of the storage tube 120, and protrudes radially inward, such as an annular protrusion or a dot-shaped protrusion. In some embodiments, the storage tube 120 includes a main tube 122 and a tail tube 123, the distal end of the tail tube 123 is fixed to the inner side of the proximal end of the main tube 122, and the distal end of the tail tube 123 forms a step with the inner wall of the main tube 122, and the step constitutes the limiting portion 121. In some embodiments, the clip device 100 includes a connecting shaft 131 for connecting the proximal ends of the two clips 110 , and at least one end of the connecting shaft 131 constitutes a mating portion 150 .

[0084] Figure 5 2 is an exemplary structural diagram of the distal end structure of the core shaft 220 according to some embodiments of the present specification. Figure 6 is based on Figure 5 A partial enlarged view of region B of the distal end structure of mandrel 220 is shown. Figure 7 It is a partial enlarged view of the clip 110 and the side wing 410 after being matched according to some embodiments of this specification. Figure 8 is a side view of the distal end structure of the core shaft 220 according to some embodiments of the present specification.

[0085] like Figures 5 and 6 As shown, the blocking portion 400 includes two side wings 410, which are respectively located on both sides of the first connecting portion 221, and are used to press the proximal end of the clip 110 onto the first connecting portion 221. In some embodiments, the proximal ends of the side wings 410 are fixed to the core shaft 220 or the first connecting portion 221, and the distal ends of the side wings 410 form a gap with the first connecting portion 221. The obstructed portions 140 at the proximal ends of the two clips 110 extend into the gaps on both sides of the first connecting portion 221, respectively, and the side wings 410 can limit the proximal ends of the two clips 110 to both sides of the first connecting portion 221 in the radial direction.

[0086] In some embodiments, reinforcing ribs 413 and / or welding points 414 are provided on the side wings 410 to increase the strength of the side wings 410 and prevent the side wings 410 from accidentally breaking or deforming, which may cause the proximal limit failure of the clip 110 .

[0087] In some embodiments, the wing 410 includes a body 411 and a pre-tightening portion 412, the proximal end of the body 411 is fixed to the distal end of the mandrel 220, the distal end of the body 411 is connected to the pre-tightening portion 412, and the pre-tightening portion 412 is configured to provide a pre-tightening force to the proximal end of the clip 110, and the pre-tightening force presses the proximal end of the clip 110 against the first connecting portion 221. When the clip 110 moves axially in an unlocked state, it can prevent the proximal end of the clip 110 from accidentally escaping from the gap between the wing 410 and the first connecting portion 221, thereby avoiding unexpected situations such as the clip 110 self-locking in advance or locking failure. In some embodiments, the pre-tightening portion 412 can be formed by bending the distal end of the body 411 at a certain angle. In some other embodiments, the distal end of the body 411 includes an elastic protrusion protruding toward the first connecting portion 221, and the elastic protrusion is configured as the pre-tightening portion 412.

[0088] like Figure 7 As shown, in some embodiments, the pre-tightening force generated by the pre-tightening portion 412 on the clip 110 forms a first preset angle α between the proximal end of the clip 110 and the first connecting portion 221. For example, the first preset angle α ranges from 0 to 10°, and preferably, the first preset angle α is about 5°. By designing appropriate side wings 410 and pre-tightening force, the side wings 410 have sufficient pre-tightening force on the proximal end of the clip 110 to ensure that the clip 110 can maintain a proper position and stability in the working state. The angle design also enables the distal end of the clip 110 to form a sufficient span, thereby effectively clamping the target tissue.

[0089] like Figure 8 As shown, in some embodiments, the pre-tightening portion 412 of the wing 410 is formed by bending the distal end of the body 411 toward the first connecting portion 221 at a certain angle, and the connection between the pre-tightening portion 412 and the body 411 forms a second preset angle β, and the second preset angle β is arranged facing the direction of the first connecting portion 221. For example, the second preset angle ranges from 150° to 180°, and preferably, the second preset angle β is about 160°. Within this angle range, the pre-tightening force of the wing 410 on the obstructed portion 140 of the clip 110 is within a suitable range, which can ensure the stability of the clip 110 in the unlocked state and the wing 410 to prevent accidental falling off, and can also ensure that the clip 110 can be smoothly released from the wing 410 when locked to prevent the clip 110 from being unable to separate.

[0090] Fig. 9 is an exemplary structural diagram of a clip 110 according to some embodiments of the present specification. Fig.10 1 is an exemplary structural diagram of the storage tube 120 shown in some embodiments of the present specification.

[0091] like Fig. 9 and Fig.10As shown, in some embodiments, the storage tube 120 includes a locking portion 125, and the clip 110 includes a locked portion 115. After the blocking portion 400 and the blocked portion 140 are released from constraints, the proximal end of the clip 110 is deformed or displaced radially outward so that the locking portion 125 cooperates with the locked portion 115.

[0092] In some embodiments, when the clip 110 is in a closed state, the bent portion 112 retracts into the receiving tube 120 and generates elastic compression. After the blocking portion 400 and the blocked portion 140 are released from constraints, the bent portion 112, under the action of the elastic restoring force, drives the proximal end of the clip 110 to automatically deform or displace radially outward, so that the locking portion 125 and the locked portion 115 automatically form a fit.

[0093] In some embodiments, the locking portion 125 and the locked portion 115 form a limited fit on the side wall of the storage tube 120. In some embodiments, the locking portion 125 includes a first recessed portion provided on the side wall of the storage tube 120, and the locked portion 115 includes a first protrusion provided on the proximal end of the clip 110 and protruding radially outward, and the first recessed portion cooperates with the first protrusion, and the clip device 100 is locked. In some embodiments, the first recessed portion includes but is not limited to a groove, a hole, etc. For example, the first recessed portion may be a groove formed on the side wall of the storage tube 120, and the groove extends along the circumference of the storage tube 120 and has a certain length, so that the first protrusion is accurately matched into the groove. The first protrusion includes but is not limited to a protrusion, a flange, a hook structure, etc. For example, the first protrusion is formed on one side edge of the proximal end of the clip 110 and protrudes radially outward, wherein the radial direction refers to the radial direction of the storage tube 120 when the clip 110 is assembled in the storage tube 120. By providing the first concave portion and the first convex portion to cooperate with each other, the clip 110 and the receiving tube 120 are limited in both the axial direction and the radial direction, thereby improving the locking stability.

[0094] In some embodiments, when the obstructed portion 140 of the clip 110 cooperates with the wing 410 , the locked portion 115 of the clip 110 and the wing 410 form an abutment limit, which can prevent the clip 110 from swinging in the radial direction and causing closing dislocation.

[0095] like Figure 5As shown, the first connection part 221 includes a first limiting groove 222 and a second limiting groove 223. In the unlocked state, the first limiting groove 222 is connected to the second connection part 130; when the core shaft 220 moves from the distal end to the proximal end, the first limiting groove 222 is deformed or displaced due to the first force and is released from the second connection part 130, so that the second limiting groove 223 is connected to the second connection part 130, and the blocking part 400 and the blocked part 140 are axially relatively displaced and are released from the constraint; when the core shaft 220 continues to move from the distal end to the proximal end, the second limiting groove 223 is deformed or displaced due to the second force and is released from the second connection part 130, and the first connection part 221 and the second connection part 130 are released. The first deformation or displacement of the first connecting portion 221 locks the clip device 100, and the second deformation or displacement of the first connecting portion 221 releases the mandrel 220 and the clip 110, thereby making the operation more precise and reliable, reducing the possibility of misoperation and improving the safety of the operation. For more exemplary embodiments of the first connecting portion 221, see Fig.11A , Fig. 11B , Fig.18 , FIG. 29A to FIG. 29C , Fig.31A , Fig.31B And the related description will not be repeated in this manual.

[0096] In some embodiments, the storage tube 120 includes a limiting structure 127 disposed at its distal end, and the limiting structure 127 is configured to limit the distal movement of the clip 110 when the clip 110 is opened, so as to prevent the clip 110 from excessively extending or falling out of the storage tube 120. In some embodiments, the limiting structure 127 is disposed perpendicular to the axis of the storage tube 120.

[0097] like Figures 1 to 5 As shown, some embodiments of the present specification further provide a clip instrument 10 , which includes a delivery device 200 and a clip device 100 .

[0098] In some embodiments, the delivery device 200 includes a sheath tube 210 and a core shaft 220 disposed in the sheath tube 210, and the distal end of the core shaft 220 includes a first connection portion 221; the clip device 100 includes at least two clips 110, a storage tube 120 and a second connection portion 130, and the storage tube 120 is disposed at the distal end of the sheath tube 210. The clip 110 and the core shaft 220 are releasably connected through the first connection portion 221 and the second connection portion 130, and the clip device 100 includes an unlocked state, a locked state, and a released state. More embodiments here can be found in Figures 1 to 4 And the related descriptions are not repeated here in this manual.

[0099] In the unlocked state, the first connection part 221 and the second connection part 130 form a first mating state, and the proximal end of the clip 110 is axially movable in the storage tube 120. In the locked state, the first connection part 221 is deformed or displaced due to the first force, and forms a second mating state with the second connection part 130, and the proximal end of the clip 110 is locked with the storage tube 120. The first mating state and the second mating state include but are not limited to: different parts of the first connection part 221 are mated with the second connection part 130, and / or the first connection part 221 is mated with the second connection part 130 in different deformation forms. In some embodiments, when the clip device 100 is in the locked state, that is, the process of the first connection part 221 and the second connection part 130 being converted to the second mating state, it can directly or indirectly trigger the blocking part 400 and the obstructed part 140 to release the constraint, and the proximal end of the clip 110 is deformed radially outward to be mated with the storage tube 120.

[0100] In the released state, the first connection portion 221 is deformed or displaced due to the second force, and is released from the second connection portion 130 , and the core shaft 220 is released from the clip 110 .

[0101] According to the clamp instrument 10 in the above scheme, the first connecting part 221 and the second connecting part 130 have a first matching state. Under a first force, the first connecting part 221 and the second connecting part 130 switch to a second matching state, and the clamp device 100 is locked. Under a second force, the first connecting part 221 and the second connecting part 130 are released. This method of controlling the clamp device 100 to enter different states in steps by the first force and the second force not only ensures that the clamp device 100 is reliably self-locking, but also makes the operation of the clamp device 100 more precise and reliable, reduces misoperation, and improves surgical safety.

[0102] Fig.11A is a front view of the distal end structure of the mandrel 220 shown in some embodiments of the present specification Figure 1 . Fig. 11B is a front view of the distal end structure of the mandrel 220 shown in some embodiments of the present specification Figure 2 .

[0103] like Figure 5 , Figure 7 and Fig. 9 As shown, in some embodiments, the first connection portion 221 includes a first limiting groove 222 and a second limiting groove 223, and the second connection portion 130 includes a connecting shaft 131; the proximal ends of the two clips 110 include an assembly hole 114, and the assembly hole 114 can be movably matched with the connecting shaft 131. Among them, the assembly hole 114 can move relative to the axial direction of the connecting shaft 131, so that the proximal ends of the clips 110 can move closer to each other or farther away from each other relative to the radial direction of the receiving tube 120.

[0104] In some embodiments, the clip device 100 is in an unlocked state, and the first limiting groove 222 is connected to the connecting shaft 131. The core shaft 220 drives the connecting shaft 131 to move along the axial direction of the receiving tube 120 through the first connecting portion 221.

[0105] When the core shaft 220 moves from the distal end to the proximal end, the first limiting groove 222 is deformed or displaced due to the first force and is released from the connection shaft 131, so that the second limiting groove 223 is connected to the connection shaft 131, and the clamp device 100 enters a locked state. When the connection shaft 131 moves to the limiting portion 121 that contacts the receiving tube 120, the connection shaft 131 no longer continues to move toward the proximal end. At this time, the core shaft 220 continues to move toward the proximal end, so that the force between the first limiting groove 222 and the connection shaft 131 reaches the first force, the first limiting groove 222 is deformed or displaced, so that the connection shaft 131 is disengaged from the first limiting groove 222 and is matched with the second limiting groove 223. During the process of the connecting shaft 131 switching from the first limiting groove 222 to the second limiting groove 223, an axial relative displacement occurs between the first connecting portion 221 and the second connecting portion 130, directly triggering the obstructed portion 140 of the clip 110 to disengage from the side wing 410, and the proximal end of the clip 110 deforms radially outward and locks with the storage tube 120.

[0106] When the core shaft 220 continues to move from the distal end to the proximal end, the second limiting groove 223 is deformed or displaced due to the second force and is released from the connection shaft 131, and the first connection portion 221 and the second connection portion 130 are released. After the clamp device 100 is locked, the core shaft 220 continues to move from the distal end to the proximal end, and the connection shaft 131 is abutted by the limiting portion 121 and cannot continue to move toward the proximal end. When the force between the second limiting groove 223 and the connection shaft 131 increases to the second force, the second limiting groove 223 is deformed or displaced, so that the connection shaft 131 and the second limiting groove 223 are released.

[0107] like Fig.11A and Fig. 11B As shown, the first limiting groove 222 is located at the proximal end of the first connecting portion 221 and is arranged on the central axis of the mandrel 220, and the second limiting groove 223 is located at the distal end of the first connecting portion 221 and is offset relative to the central axis of the mandrel 220. In this way, when the connecting shaft 131 is disengaged from the first limiting groove 222, it can accurately fit into the second limiting groove 223 to ensure control accuracy. In some embodiments, the first limiting groove 222 is arranged on the central axis of the mandrel 220, which means that the geometric center point of the first limiting groove 222 is arranged on the central axis of the mandrel 220; the second limiting groove 223 is offset relative to the central axis of the mandrel 220, which means that the geometric center point of the second limiting groove 223 is offset from the central axis of the mandrel 220.

[0108] In some embodiments, the range of the third preset angle γ between the opening direction of the first limiting groove 222 and the opening direction of the second limiting groove 223 includes 90° to 180°, so that the first limiting groove 222 can be automatically calibrated with the second limiting groove 223 after deformation, ensuring that the connecting shaft 131 can be accurately docked with the second limiting groove 223, and realizing step-by-step control of locking and release. Among them, the opening direction refers to the line connecting the geometric center point of the first limiting groove 222 (or the second limiting groove 223) and the center point of the slot and points to the direction outside the first limiting groove 222 (or the second limiting groove 223). In some embodiments, the third preset angle γ is approximately 125°, so that the first connecting portion 221 only undergoes elastic deformation without breaking, thereby reducing the generation of fragments and improving surgical safety; and the force value of the first connecting portion 221 can meet the target requirements, thereby ensuring safety and stability during the operation; and, through optimized design, the increase in the axial size of the first connecting portion 221 after deformation is minimized, and through unilateral force, the first connecting portion 221 after the final deformation can be smoothly retracted into the sheath 210.

[0109] In some embodiments, the fourth preset angle θ between the opening direction of the first limiting groove 222 and the central axis of the core shaft 220 is in the range of 40° to 90°. Preferably, the fourth preset angle θ is about 55°. In this way, it can ensure that the connecting shaft 131 accurately matches the second limiting groove 223 after being released from the first limiting groove 222, and reduce the risk of the first limiting groove 222 breaking and the generation of fragments.

[0110] In some embodiments, the second connection portion 130 includes a connection shaft 131, and the first limiting groove 222 is configured to completely accommodate the connection shaft 131. For example, the shape and size of the first limiting groove 222 can be adapted to the cross section of the connection shaft 131 to ensure the connection stability between the first connection portion 221 and the second connection portion 130. In some embodiments, the opening size of the first limiting groove 222 is smaller than the diameter of the connection shaft 131 to prevent the connection shaft 131 from escaping from the first limiting groove 222 that has not yet been deformed. In some embodiments, the range of the opening size L1 of the first limiting groove 222 includes 0.1mm to 0.3mm. Preferably, the opening size L1 of the first limiting groove 222 can be about 0.2mm. In this way, the matching stability of the connection shaft 131 and the first limiting groove 222 can be ensured, and the connection shaft 131 can be prevented from escaping from the opening of the first limiting groove 222 that has not yet been deformed.

[0111] In some embodiments, the second limiting groove 223 is configured to at least partially accommodate the connecting shaft 131. For example, the second limiting groove 223 can completely accommodate the connecting shaft 131; or, the second limiting groove 223 can only accommodate a portion of the connecting shaft 131. The second limiting groove 223 mainly plays a temporary blocking role for the connecting shaft 131, and it is not necessary to make the connecting shaft 131 completely inserted into the second limiting groove 223. Therefore, the overall size of the second connecting groove can be relatively small, so as to reduce the radial size of the first connecting portion 221, so that it can be smoothly retracted into the sheath tube 210 after deformation.

[0112] In some embodiments, the first connection portion 221 includes a first deformation zone, which is arranged corresponding to the first limiting groove 222 and is configured to deform under a first force. The first deformation zone may be a portion that can deform around the first limiting groove 222 when the first limiting groove 222 is subjected to force.

[0113] In some embodiments, the first deformation zone has a larger size than other areas around the first limiting groove 222. The maximum size L2 of the first deformation zone ranges from 0.55 mm to 0.65 mm; preferably, the maximum size L2 of the first deformation zone is about 0.6 mm.

[0114] In some embodiments, the first connection portion 221 includes a second deformation zone, which is arranged corresponding to the second limiting groove 223 and is configured to deform under the second force. The second deformation zone can be a part that can deform around the second limiting groove 223 when the second limiting groove 223 is subjected to force.

[0115] In some embodiments, the second deformation zone has a larger size than other areas around the second limiting groove 223. The maximum size L3 of the second deformation zone ranges from 0.35 mm to 0.45 mm. Preferably, the maximum size L3 of the second deformation zone is about 0.4 mm.

[0116] like Figure 8 As shown, in some embodiments, the thickness L4 of the first connection portion 221 ranges from 0.15 mm to 0.3 mm. Preferably, the thickness L4 of the first connection portion 221 is about 0.2 mm.

[0117] By optimizing the structure and size of the first connection portion 221, especially optimizing the size design of the first deformation zone and the second deformation zone, the first force and the second force can cause these areas to deform within a reasonable range, which is beneficial to controlling the motion state of the connecting shaft 131. At the same time, the first deformation zone and the second deformation zone undergo a more reasonable deformation when subjected to a predetermined force, thereby avoiding structural fracture caused by excessive deformation, reducing the generation of fragments, and improving surgical safety.

[0118] In some embodiments, the first limiting groove 222 is deformed by the first force, and the second limiting groove 223 is deformed by the second force. The force value of the first force is smaller than the force value of the second force, so that the first limiting groove 222 is deformed and separated from the connecting shaft 131 under the first force, and the mandrel 220 deforms the second limiting groove 223 and separates from the connecting shaft 131 only after applying a larger second force, which is conducive to controlling the deformation timing of the first limiting groove 222 and the second limiting groove 223 by different degrees of force, thereby improving the control precision and accuracy.

[0119] In some embodiments, the force value range of the first force includes 20N to 50N; further, the force value range of the first force includes 37N to 47N. Preferably, the first force is about 42N.

[0120] In some embodiments, the force value range of the second force includes 30N to 60N; further, the force value range of the second force includes 45N to 55N. Preferably, the second force is about 50N.

[0121] By controlling the first force and the second force within the above range, the first limit groove 222 and the second limit groove 223 can be deformed reasonably, so that the connecting shaft 131 can be smoothly switched from the first limit groove 222 to the second limit groove 223, and the risk of the first connecting part 221 breaking can be reduced to avoid the generation of fragments.

[0122] In some embodiments, the first connection portion 221 has at least one of the following material performance parameters: tensile strength greater than or equal to 520 MPa; yield strength greater than or equal to 205 MPa; elongation greater than or equal to 40%; hardness less than or equal to 187 N / mm2. When selecting materials, materials that can achieve similar performance can be used as the material of the first connection portion 221. The material performance and size design of the first connection portion 221 complement each other, and both can promote reasonable deformation of the deformation area and reduce the generation of fragments.

[0123] like Figure 3 , Figure 4 and Fig.10As shown, in some embodiments, the clip device 10 further includes a connecting pin 230, and the storage tube 120 and the sheath tube 210 can be releasably connected through the connecting pin 230. In some embodiments, the proximal end of the storage tube 120 includes at least two first limiting holes 124, and the distal end of the sheath tube 210 includes second limiting holes 211 arranged respectively corresponding to the first limiting holes 124. The connecting pin 230 includes a tube portion 231 and at least two arms 232 extending from the tube portion 231 to the distal end. A limiting hook is provided at the distal end of each arm 232, and each limiting hook passes through the first limiting hole 124 and the second limiting hole 211, respectively, so that the storage tube 120 and the sheath tube 210 can be releasably connected. In some embodiments, the sheath tube 210 includes a spring end 240, and the spring end 240 is fixed (such as welded) at the distal end of the sheath tube 210. The tube portion 231 of the connecting pin 230 is arranged in the spring end 240, and the second limiting hole 211 is arranged on the side wall of the spring end 240. The spring end 240 is provided to facilitate assembly of various components.

[0124] In some embodiments, the distal end of the mandrel 220 includes an actuating portion 227, and the connecting pin 230 is configured such that: after the clip device 100 is locked, the mandrel 220 moves from the distal end to the proximal end, and the actuating portion 227 actuates the connecting pin 230 to deform and / or displace, so that the receiving tube 120 and the sheath tube 210 are released. In some embodiments, the actuating portion 227 is constituted by the side wing 410 at the distal end of the mandrel 220. In some other embodiments, the distal end of the mandrel 220 is provided with a protrusion, which constitutes the actuating portion 227. In some other embodiments, the actuating portion 227 is constituted by the connecting hook 226 at the distal end of the mandrel 220.

[0125] FIG. 12A to FIG. 15 is a schematic diagram of the operation process of the clip instrument 10 according to some embodiments of the present specification.

[0126] like Fig. 12A and Fig. 12B As shown, after the clip device 100 performs operations such as opening, clamping, and closing, the core shaft 220 moves from the distal end to the proximal end until the matching portion 150 of the clip device 100 abuts against the limiting portion 121 of the receiving tube 120, limiting the clip 110 from continuing to move toward the proximal end. At this time, the first connecting portion 221 is in an undeformed state, and the second connecting portion 130 cooperates with the first limiting groove 222; the blocking portion 400 acts on the blocked portion 140 in the radial direction, and the radial gap between the proximal end of the clip 110 and the receiving tube 120 is maintained within a preset range.

[0127] like Fig.13A and Fig. 13BAs shown, the core shaft 220 continues to move from the distal end to the proximal end, so that a first force is generated between the first connection part 221 and the second connection part 130, and the first force causes the first limiting groove 222 to deform, and the second connection part 130 is disengaged from the first limiting groove 222 and matched with the second limiting groove 223. When the second connection part 130 switches from the first limiting groove 222 to the second limiting groove 223, an axial relative displacement occurs between the first connection part 221 and the second connection part 130, thereby triggering the blocking part 400 and the blocked part 140 to release the constraint, such as the proximal end of the clip 110 is disengaged from the side wing 410; then, the proximal end of the clip 110 is deformed or displaced radially outward to approach the side wall of the storage tube 120, so that the locking part 125 and the locked part 115 form a limiting match, and the clip device 100 enters a locked state.

[0128] like Fig.14 As shown, the core shaft 220 continues to move from the distal end to the proximal end, so that a second force is generated between the first connecting part 221 and the second connecting part 130, and the second force causes the second limiting groove 223 to deform, and the second connecting part 130 disengages from the second limiting groove 223. At this time, the first connecting part 221 and the second connecting part 130 are released from the core shaft 220 and the clip 110.

[0129] like Fig.15 As shown, the core shaft 220 continues to move from the distal end to the proximal end, and the actuating portion 227 at the distal end of the core shaft 220 drives the connecting pin 230 to move from the distal end to the proximal end. The support arm 232 of the connecting pin 230 is deformed or displaced by the force, and escapes from the first limiting hole 124 of the storage tube 120 and the second limiting hole 211 of the sheath tube 210. At this time, the sheath tube 210 and the storage tube 120 are released.

[0130] The following will continue to introduce subsequent embodiments based on the above-mentioned embodiment 1. The structures or features in the subsequent embodiments that are the same or substantially the same as those in the embodiment 1 will not be repeated, and only the differences from the embodiment 1 will be described in detail.

[0131] Hereinafter, this specification will introduce another technical solution of the clip device 10 in detail through the second embodiment. Compared with the first embodiment, the difference in the second embodiment mainly lies in the blocking part 400 and the first connecting part 221 and related structures.

[0132] Fig.16 is an exemplary structural diagram of the distal end structure of the clip instrument 10 shown in some embodiments of the present specification. Fig.17 1 is an exemplary structural diagram of the storage tube 120 shown in some embodiments of the present specification. Fig.18 2 is an exemplary structural diagram of the distal end structure of the core shaft 220 according to some embodiments of the present specification. Fig.19is an exemplary structural diagram of a clip 110 according to some embodiments of the present specification.

[0133] like Figures 16 to 19 As shown, in some embodiments, the blocking portion 400 is disposed in the storage tube 120 and protrudes radially inward, and the blocking portion 400 is configured to contact the obstructed portion 140 to form a sliding constraint after at least two clips 110 are closed. Among them, the sliding constraint refers to a constraint mode in which an object can only be displaced in a specific direction (such as axial direction) and cannot move in other directions. When the clip 110 moves from the distal end to the proximal end, the blocking portion 400 acts on the obstructed portion 140, and the blocking portion 400 slides relative to the obstructed portion 140, and the proximal end of the clip 110 is radially close, and the gap with the side wall of the storage tube 120 is maintained within a preset range. By setting the blocking portion 400 and the obstructed portion 140 as sliding constraints, the clip 110 is constrained within a specific range of travel, which is conducive to controlling the locking process of the clip 110 through the movement range of the clip 110, rather than relying on the force of the core shaft 220, making the operation simpler and more intuitive, and reducing the risk of misoperation.

[0134] In some embodiments, the clip 110 includes a release hole 116, which is located at the distal end of the obstructed portion 140. When the blocking portion 400 slides from the obstructed portion 140 to the release hole 116, the blocking portion 400 and the obstructed portion 140 are released from the constraints. At this time, the proximal end of the clip 110 is deformed or displaced radially outward and is locked with the side wall of the storage tube 120.

[0135] In some embodiments, the blocking portion 400 includes at least two tube arms 420, the distal ends of the tube arms 420 are connected to the storage tube 120, and the proximal ends protrude from the inner wall of the storage tube 120. When the clip 110 is closed, the tube arms 420 and the obstructed portion 140 of the clip 110 are in sliding contact. When the tube arms 420 slide into the release hole 116, the contact relationship between the tube arms 420 and the obstructed portion 140 is released, and the proximal end of the clip 110 moves radially outward, so that the tube arms 420 are inserted into the release hole 116, and the locked portion 115 at the proximal end of the clip 110 is limitedly matched with the locking portion 125 of the side wall of the storage tube 120. Here, the tube arms 420 and the release hole 116 also form a limited match, thereby enhancing the locking stability.

[0136] In some embodiments, the tube arms 420 include four, and two tube arms 420 are respectively arranged at the position corresponding to each clip 110, and a passage is formed between the two tube arms 420 to avoid the tube arms 420 from interfering with the movement of the connecting shaft 131. In some embodiments, the release holes 116 are arranged corresponding to the number of the tube arms 420. For example, two release holes 116 are arranged on each clip 110, and each release hole 116 is respectively arranged on both sides of the assembly hole 114 and communicated with the assembly hole 114 to reduce the size of the proximal end of the clip 110.

[0137] In some embodiments, the first connecting portion 221 may include only one limiting groove 2211, which is adapted to the connecting shaft 131. When the clamp device 100 is locked, the core shaft 220 continues to move from the distal end to the proximal end, causing the connecting shaft 131 to disengage from the limiting groove 2211, and the core shaft 220 and the clip 110 are released.

[0138] In some embodiments, a radially enlarged actuating portion 227 is provided at the distal end of the core shaft 220 for actuating the connecting pin 230 to move toward the proximal end so that the receiving tube 120 and the sheath tube 210 are released.

[0139] Figures 20 to 23B It is a schematic diagram of the operation process of the clip instrument 10 shown in some embodiments of the present specification.

[0140] like Fig. 20 As shown, the clip device 100 is in an open state, the first connecting portion 221 is connected to the second connecting portion 130, and the blocking portion 400 is not in contact with the blocked portion 140.

[0141] like Fig.21 As shown, the clip device 100 is in a closed state. The core shaft 220 moves from the distal end to the proximal end, driving the clip 110 to close, and the proximal end of the clip 110 moves to abut against the blocking portion 400. The blocking portion 400 acts on the blocked portion 140 in the radial direction, so that the proximal end of the clip 110 maintains a gap with the side wall of the receiving tube 120. In the process of the core shaft 220 moving toward the proximal end, the blocking portion 400 forms a sliding constraint on the blocked portion 140.

[0142] As Fig. 22 As shown, the clip device 100 is in a locked state. The core shaft 220 moves from the distal end to the proximal end, so that the blocking portion 400 slides from the blocked portion 140 to the release hole 116, and the blocking portion 400 and the blocked portion 140 are released from the constraints. At this time, the proximal end of the clip 110 is deformed or displaced radially outward, so that the locked portion 115 cooperates with the locking portion 125 to form a lock on the side wall of the storage tube 120. At the same time, the blocking portion 400 and the release hole 116 also form a locked state.

[0143] like Fig.23A and Fig. 23B As shown, the clip device 100 is in a released state. The core shaft 220 moves from the distal end to the proximal end, so that the first connecting portion 221 is separated from the second connecting portion 130. At the same time, the actuating portion 227 at the distal end of the core shaft 220 actuates the connecting pin 230 to release the first limiting hole 124 and the second limiting hole 211, so that the sheath tube 210 and the receiving tube 120 are separated.

[0144] Hereinafter, this specification will introduce another technical solution of the clip device 10 in detail through the third embodiment. Compared with the first embodiment, the third embodiment is different mainly in the locked portion 115 and the locking portion 125 and their related structures.

[0145] Fig.24 1 is an exemplary structural diagram of the storage tube 120 shown in some embodiments of the present specification. Fig.25 is an exemplary structural diagram of a clip 110 according to some embodiments of the present specification.

[0146] In some embodiments, the locking portion 125 and the locked portion 115 form a limiting fit inside the storage tube 120 to prevent the locked portion 115 from protruding from the side wall of the storage tube 120, making the structure more compact.

[0147] In some embodiments, the locking portion 125 includes a second protrusion provided on the side wall of the receiving tube 120 and protruding radially inward, and the locked portion 115 includes a second recess provided on the clip 110, and the second recess cooperates with the second protrusion, so that the clip device 100 is locked. In some embodiments, the second protrusion can be similar to the structure of the above-mentioned tube arm 420, at least two tube arms 420 are arranged corresponding to at least two clips 110, the distal end of the tube arm 420 is connected to the receiving tube 120, and the proximal end protrudes from the inner wall of the receiving tube 120. In some embodiments, the second recess can be similar to the structure of the above-mentioned release hole 116. Since the obstructed portion 140 of the clip 110 cooperates with the wing 410 at the distal end of the core shaft 220, the function of the tube arm 420 is only as the locking portion 125. In some embodiments, the second recess is a locking hole provided at the proximal end of the clip 110, and the locking hole is located at the distal end of the obstructed portion 140. When the obstruction portion 140 of the clip 110 is released from the side wing 410 , the proximal end of the clip 110 is deformed or displaced radially outward, so that the tube arm 420 is matched with the locking hole, thereby locking the clip device 100 .

[0148] Figures 26 to 28C It is a schematic diagram of the operation process of the clip instrument 10 shown in some embodiments of the present specification.

[0149] like Fig.26 As shown, the clip device 100 is in a closed state. The core shaft 220 moves from the distal end to the proximal end, driving the clip 110 to close, and the side wings 410 act on the obstructed portion 140 in the radial direction, so that the proximal end of the clip 110 and the side wall of the receiving tube 120 always maintain a gap. During the movement of the core shaft 220 toward the proximal end, the locking portion 125 is in a suspended state.

[0150] like Fig. 27As shown, the clip device 100 is in a locked state. The core shaft 220 continues to move from the distal end to the proximal end, so that a first force is generated between the first connection part 221 and the second connection part 130, and the first force causes the first limiting groove 222 to deform, and the second connection part 130 is disengaged from the first limiting groove 222 and fits into the second limiting groove 223. When the second connection part 130 switches from the first limiting groove 222 to the second limiting groove 223, an axial relative displacement occurs between the first connection part 221 and the second connection part 130, thereby triggering the side wing 410 and the obstructed part 140 to release the constraint; then, the proximal end of the clip 110 is deformed or displaced radially outward to approach the side wall of the storage tube 120, so that the locking part 125 and the locked part 115 form a limiting fit, and the clip device 100 enters a locked state.

[0151] like FIG. 28A to FIG. 28C As shown, the clip device 100 is in a released state. The core shaft 220 moves from the distal end to the proximal end, so that the first connecting portion 221 is separated from the second connecting portion 130. At the same time, the actuating portion 227 at the distal end of the core shaft 220 actuates the connecting pin 230 to disengage from the first limiting hole 124 and the second limiting hole 211, so that the sheath tube 210 and the receiving tube 120 are separated. At this time, the locking portion 125 and the locked portion 115 maintain a mating state, and the clip device 100 maintains a locked state.

[0152] Hereinafter, this specification will introduce another technical solution of the clip device 10 in detail through the fourth embodiment. Compared with the first embodiment, the difference in the fourth embodiment mainly lies in the first connecting portion 221 and its related structures.

[0153] Fig.29A is an exemplary isometric view of the distal end structure of the mandrel 220 according to some embodiments of the present specification. Fig.29B is based on Fig.29A An exemplary front view of the distal end structure of mandrel 220 is shown. Fig.29C is based on Fig.29A An exemplary side view of the distal end structure of mandrel 220 is shown.

[0154] like FIG. 29A to FIG. 29C As shown, in some embodiments, the first limiting groove 222 and the second limiting groove 223 of the first connecting portion 221 are both arranged on the central axis of the core shaft 220, so that the interaction force between it and the second connecting portion 130 is along the central axis of the core shaft 220, which is more labor-saving and more stable.

[0155] In some embodiments, a guide channel 224 is formed between the first limiting groove 222 and the second limiting groove 223, and the guide channel 224 is configured to guide the second connection part 130 into the second limiting groove 223 after the first limiting groove 222 is deformed; a release port 225 is formed at the distal end of the second limiting groove 223, and the release port 225 is configured to release the second connection part 130 after the second limiting groove 223 is deformed. In this way, the movement of the connecting shaft 131 is sequentially along the first limiting groove 222, the guide channel 224, and the second limiting groove 223, and then escapes from the release port 225, and the entire movement path is along the central axis of the core shaft 220, which reduces structural vibration and improves stability.

[0156] In some embodiments, the first connection portion 221 has elastic deformation capability, so that the first limiting groove 222 can return to its original shape after deformation, thereby ensuring the connection stability between the second connection portion 130 and the second limiting groove 223 .

[0157] In some embodiments, the width of the guide channel 224 is smaller than the diameter of the connecting shaft 131; the width of the release port 225 is smaller than the diameter of the connecting shaft 131. In some embodiments, the first limiting groove 222 and / or the second limiting groove 223 are hole-shaped grooves, and the aperture range of the first limiting groove 222 and / or the second limiting groove 223 includes 0.5mm to 0.6mm; the width range of the guide channel 224 includes 0.2mm to 0.3mm. Among them, the width of the guide channel 224 refers to the dimension perpendicular to the axial direction of the core shaft 220. The first connecting portion 221 is configured to have the above-mentioned dimensions so that it only deforms but does not break when subjected to force, reduces the generation of fragments, and improves surgical safety.

[0158] FIG. 30A to FIG. 30C It is a schematic diagram of the relative movement process of the first connection part 221 and the second connection part 130 shown in some embodiments of this specification.

[0159] like Fig. 30A As shown, the clip device 100 is in an unlocked state. The second connection portion 130 cooperates with the first limiting groove 222, and the first connection portion 221 is in an undeformed state.

[0160] like Fig. 30B As shown, the core shaft 220 moves from the distal end to the proximal end, so that the second connection part 130 leaves the first limiting groove 222 and enters the guide channel 224, and the second connection part 130 causes the first connection part 221 to undergo a first elastic deformation.

[0161] like Fig. 30CAs shown, the mandrel 220 continues to move from the distal end to the proximal end, so that the second connection part 130 enters the second limiting groove 223. At this time, the first connection part 221 returns to its original shape, so that the second limiting groove 223 cooperates with the second connection part 130. Then, the mandrel 220 continues to move from the distal end to the proximal end, and the second connection part 130 causes the release opening 225 to deform, so that the second connection part 130 escapes from the second limiting groove 223, and the mandrel 220 and the clip 110 are released.

[0162] Hereinafter, this specification will introduce another technical solution of the clip device 10 in detail through the fifth embodiment. Compared with the first embodiment, the fifth embodiment is different mainly in the first connecting portion 221, the second connecting portion 130, the blocking portion 400 and related structures.

[0163] Fig.31A It is an exemplary structural diagram of the first predetermined form of the first connecting portion 221 shown in some embodiments of this specification. Fig.31B It is an exemplary structural diagram of the second predetermined form of the first connecting portion 221 shown in some embodiments of this specification. Fig.32 is an exemplary structural diagram of a clip 110 according to some embodiments of the present specification.

[0164] like Figures 31A to 32 As shown, in some embodiments, the first connection portion 221 includes two connection hooks 226, and the second connection portion 130 is a connection hole 132 disposed at the proximal end of each clip 110. In some embodiments, the connection hook 226 includes an arm 2261 and a hook 2262, wherein the proximal end of the arm 2261 is connected to the core shaft 220, and the distal end is connected to the hook 2262. In some embodiments, the hook 2262 includes a first limiting area 2263 and a second limiting area 2264, wherein one end of the first limiting area 2263 is connected to the arm 2261, and the other end is connected to the second limiting area 2264. In some embodiments, a first barb 2265 is disposed at the connection between the first limiting area 2263 and the second limiting area 2264, and a second barb 2266 is disposed at the distal end of the second limiting area 2264.

[0165] In the unlocked state, the two connecting hooks 226 are respectively matched with the connecting holes 132 of the two clips 110, for example, the connecting hooks 226 are matched with the connecting holes 132 in a first predetermined form, so that the first connecting portion 221 is connected to the second connecting portion 130; wherein the first predetermined form refers to the form in which the connecting hook 226 is not deformed, at which time the first limiting area 2263 of the connecting hook 226 passes through the connecting hole 132, and the first barb 2265 forms a limit with the connecting hole 132. In some embodiments, the first predetermined form can be that the arm portions 2261 of the two connecting hooks 226 are close to each other, so that the proximal end of the clip 110 can maintain a preset gap with the inner wall of the storage tube 120, and the bending degree of the hook portion 2262 relative to the arm portion 2261 satisfies the form in which the connecting hook 226 is connected to the connecting hole 132, for example, the hook portion 2262 and the arm portion 2261 are in an acute angle or a right angle.

[0166] In the locked state, when the core shaft 220 moves from the distal end to the proximal end, the connecting hook 226 undergoes a first deformation or displacement due to the first force, and the connecting hook 226 is deformed from the first predetermined form to the second predetermined form, and remains in cooperation with the connecting hole 132 in the second predetermined form, and causes the proximal end of the clip 110 to deform or displace radially outward to cooperate with the storage tube 120, and the clamp device 100 enters a locked state. The second predetermined form refers to the form in which the arm 2261 and / or the first limiting area 2263 are deformed, at which time the angle between the arm 2261 and the axis of the core shaft 220 increases, and the arms 2261 of the two connecting hooks 226 move away from each other, so that the proximal end of the clip 110 can be deformed or displaced radially outward to lock with the storage tube 120, and the degree of bending of the hook 2262 relative to the arm 2261 satisfies the form in which the connecting hook 226 and the connecting hole 132 remain connected, for example, the angle between the hook 2262 and the arm 2261 is a right angle or an obtuse angle. When the connecting hook 226 is in the second predetermined form, the connecting hole 132 crosses the first barb 2265 to cooperate with the second limiting area 2264, and the second barb 2266 forms a limit with the connecting hole 132.

[0167] In the released state, when the mandrel 220 continues to move from the distal end to the proximal end, the connecting hook 226 is deformed or displaced for the second time due to the second force, and the connecting hook 226 is deformed from the second predetermined form to the third predetermined form, and is released from the connecting hole 132 in the second predetermined form, and the first connecting portion 221 and the second connecting portion 130 are released. The third predetermined form refers to a form in which at least one of the arm 2261, the first limiting area 2263 and the second limiting area 2264 is deformed, and at this time, the angle between the hook 2262 and the arm 2261 increases, so that the connecting hook 226 can be released from the connecting hole 132. When the connecting hook 226 is in the third predetermined form, the connecting hole 132 passes over the second barb 2266 and is released from the second limiting area 2264.

[0168] In some embodiments, two connecting hooks 226 constitute the blocking portion 400, and the proximal ends of at least two clips 110 are located between the two connecting hooks 226, and the two connecting hooks 226 act radially inward on the proximal ends of the clips 110. When the connecting hooks 226 are in the first predetermined form, the connecting hooks 226 act radially inward on the obstructed portion 140 of the clip 110, so that the proximal end of the clip 110 and the receiving tube 120 maintain a predetermined range of clearance. When the connecting hooks 226 are in the second predetermined form, the connecting hooks 226 release the radial limit on the obstructed portion 140, and the proximal end of the clip 110 deforms or moves radially outward, so that the locking portion 125 and the locked portion 115 cooperate, and the clip device 100 is locked.

[0169] Figure 33 to Figure 35 It is a schematic diagram of the operation process of the clip instrument 10 shown in some embodiments of the present specification.

[0170] like Fig.33 As shown, the clip device 100 is in an unlocked state. The connecting hook 226 is in a first predetermined state, the connecting hook 226 is connected to the connecting hole 132 of the clip 110, and the connecting hook 226 acts radially inward on the obstruction portion 140, so that the proximal end of the clip 110 and the inner wall of the receiving tube 120 maintain a preset range of clearance, so as to allow the core shaft 220 to control the clip 110 to open or close repeatedly.

[0171] like Fig.34 As shown, the clip is in a locked state. The mandrel 220 moves from the distal end to the proximal end, driving the connecting hook 226 to abut against the limiting portion 121 of the receiving tube 120 (not shown in the figure for the time being), and the limiting portion 121 limits the clip 110 from continuing to move toward the proximal end. The mandrel 220 is continuously pulled, and a first force is generated between the connecting hook 226 and the connecting hole 132. The first force causes the arm 2261 and / or the first limiting area 2263 of the connecting hook 226 to deform, and the connecting hook 226 has a second predetermined shape. The connecting hook 226 releases the engagement with the obstructed portion 140, and the proximal end of the clip 110 is deformed or displaced radially outward, so that the locking portion 125 and the locked portion 115 engage, and the clip 110 is locked with the receiving tube 120.

[0172] like Fig.35 As shown, the clip device 100 is in a released state. The core shaft 220 moves from the distal end to the proximal end, and a second force is generated between the connecting hook 226 and the connecting hole 132. The second force causes at least one of the arm 2261, the first limiting area 2263 and the second limiting area 2264 of the connecting hook 226 to deform, and the connecting hook 226 has a third predetermined shape. The connecting hook 226 and the connecting hole 132 are released, and the core shaft 220 and the clip 110 are released. In the third predetermined shape, the connecting hook 226 also serves as the actuating portion 227, which actuates the connecting pin 230 to move toward the proximal end, so that the storage tube 120 and the sheath tube 210 are released.

[0173] Hereinafter, this specification will introduce another technical solution of the clip device 10 in detail through the sixth embodiment. Compared with the first embodiment, the difference in the sixth embodiment mainly lies in the storage tube 120 and its related structures.

[0174] Fig.36 is an exemplary structural diagram of the distal end structure of the clip instrument 10 shown in some embodiments of the present specification. Fig.37 1 is an exemplary structural diagram of the storage tube 120 shown in some embodiments of the present specification.

[0175] like Fig.36 and Fig.37 As shown, in some embodiments, the storage tube 120 includes two slots 126 respectively arranged corresponding to the clip 110, and the slots 126 are provided at the distal end of the storage tube 120, and the slots 126 are configured to provide an additional range of motion for the clip 110. By providing the slots 126, the movement angle of the clip 110 is increased, so that the clip 110 has a larger span in the open state, which is conducive to clamping a larger wound or tissue.

[0176] In some embodiments, the distal end of the storage tube 120 includes a limiting structure 127, which is used to limit the clip 110 from escaping from the distal end of the storage tube 120, which may limit the movement range of the clip 110. By setting the slot 126, the influence of the limiting structure 127 on the clip 110 is reduced, and the span of the clip 110 reaches the expected effect, thereby meeting the surgical requirements.

[0177] Hereinafter, this specification will introduce another technical solution of the clip device 10 in detail through the seventh embodiment. Compared with the first embodiment, the difference in the seventh embodiment mainly lies in the storage tube 120 and its related structures.

[0178] Fig.38 1 is an exemplary structural diagram of the storage tube 120 shown in some embodiments of the present specification. Fig.39 is an exemplary cross-sectional view of the distal end structure of the clip instrument 10 according to some embodiments of the present specification.

[0179] In some embodiments, the storage tube 120 includes a limiting structure 127 disposed at its distal end, and the limiting structure 127 is configured to limit the distal movement of the clip 110 when the clip 110 is opened, thereby preventing the clip 110 from dislodging distally or excessively extending out of the storage tube 120.

[0180] In some embodiments, the limiting structure 127 is arranged at an angle relative to the axis of the storage tube 120. For example, the range of the fifth preset angle η between the limiting structure 127 and the axis of the storage tube 120 includes 40° to 90°; preferably, the fifth preset angle η is about 60°. In this way, when the storage tube 120 and the clip 110 are in a locked state, when the proximal end of the storage tube 120 to the distal end of the clip 110 remains unchanged, the clip 110 has a larger range of motion at the position of the limiting structure 127, thereby increasing the span of the clip 110.

[0181] Hereinafter, this specification will introduce the operation method of the clip device 10 in detail through the eighth embodiment. The operation method can be applied to the clip device 10 in any embodiment from the first embodiment to the seventh embodiment.

[0182] Fig.40 is a flow chart of a method of operating the clip instrument 10 according to some embodiments of the present specification.

[0183] Embodiment 8 of the present specification provides an operating method of a clip device 10, the operating method comprising a process 800, and the process 800 can be performed by an operating device 300. The process 800 comprises the following steps:

[0184] In step 810, the radial clearance between the proximal end of the clip 110 and the receiving tube 120 is controlled within a preset range by the blocking portion 400. The first connecting portion 221 of the core shaft 220 and the second connecting portion 130 of the clamp device 100 have a first mating state. The core shaft 220 is operated to reciprocate along the channel of the sheath tube 210, driving the clip 110 to open or close.

[0185] In some embodiments, the clip instrument 10 includes a blocking portion 400 , and the clip 110 includes a blocked portion 140 .

[0186] In some embodiments, the blocking portion 400 is disposed at the distal end of the mandrel 220, and the obstructed portion 140 is pre-matched with the blocking portion 400. When the operating device 300 operates the first connecting portion 221 and the second connecting portion 130 through the mandrel 220 and the force is less than the first acting force, the blocking portion 400 controls the radial gap between the proximal end of the clip 110 and the receiving tube 120 within a preset range. For example, the blocking portion 400 includes two side wings 410 disposed at the distal end of the mandrel 220, and the two side wings 410 press the obstructed portions 140 of the two clips 110 against the first connecting portion 221, so that a gap is formed between the proximal end of the clip 110 and the inner wall of the receiving tube 120. For another example, the blocking portion 400 includes two connecting hooks 226 disposed at the distal end of the mandrel 220, and the two connecting hooks 226 gather the obstructed portions 140 of the two clips 110.

[0187] In some embodiments, the blocking portion 400 is disposed in the receiving tube 120 and protrudes radially inward, and a release hole 116 is disposed at the distal end of the blocked portion 140. The operating device 300 operates the release hole 116 through the mandrel 220, and the axial movement range is between the distal end of the receiving tube 120 and the blocking portion 400, so that the blocking portion 400 can act on the blocked portion 140 in the radial direction, and the blocking portion 400 controls the radial gap between the proximal end of the clip 110 and the receiving tube 120 within a preset range.

[0188] In some embodiments, the first connection portion 221 includes a first limiting groove 222 and a second limiting groove 223, and the first matching state can be a state in which the first limiting groove 222 is pre-matched with the second connection portion 130. In some embodiments, the first connection portion 221 includes a connecting hook 226, and the first matching state can be a state in which the connecting hook 226 is matched with the second connection portion 130 when it is not deformed.

[0189] In step 820, the operating core shaft 220 moves from the distal end to the proximal end, so that the first connecting part 221 and the second connecting part 130 switch to the second mating state, thereby triggering the blocking part 400 and the obstructed part 140 to release the constraint, so that the proximal end of the clip 110 deforms or moves radially outward to cooperate with the storage tube 120, and the clamp device 100 is locked.

[0190] In some embodiments, the operating device 300 operates the mandrel 220 to move from the distal end to the proximal end. When the force between the first connection part 221 and the second connection part 130 is equal to the first force, the first limit groove 222 is deformed or displaced by the first force and is released from the second connection part 130, so that the second limit groove 223 is connected to the second connection part 130, and the first connection part 221 and the second connection part 130 are switched to the second matching state. In this process, the first connection part 221 and the second connection part 130 are axially relatively displaced, triggering the blocking part 400 to release the constraint from the obstructed part 140, for example, the obstructed part 140 is disengaged from the side wing 410 at the distal end of the mandrel 220, or the tube arm 420 of the storage tube 120 is matched with the release hole 116, etc.

[0191] In some embodiments, the operating device 300 operates the mandrel 220 to move from the distal end to the proximal end, and a first force is generated between the connecting hook 226 and the connecting hole 132, and the first force causes the first limiting area 2263 of the connecting hook 226 to deform, and the second limiting area 2264 of the connecting hook 226 cooperates with the connecting hole 132. Due to the deformation of the first limiting area 2263 of the connecting hook 226, the connecting hook 226 is released from the obstructed portion 140.

[0192] In some embodiments, the storage tube 120 includes a locking portion 125, and the clip 110 includes a locked portion 115. The operating device 300 operates the blocking portion 400 to release the restraint from the blocked portion 140, and the proximal end of the clip 110 is deformed or displaced radially outward, so that the locking portion 125 cooperates with the locked portion 115. In some embodiments, the locking portion 125 includes a first recessed portion provided on the side wall of the storage tube 120, and the locked portion 115 includes a first protrusion provided on the proximal end of the clip 110, and the first recessed portion and the first protrusion form a limited fit on the side wall of the storage tube 120. In some embodiments, the locking portion 125 includes a second protrusion provided on the side wall of the storage tube 120, and the locked portion 115 includes a second recessed portion provided on the proximal end of the clip 110, and the second protrusion and the second recess form a limited fit on the inner side of the storage tube 120.

[0193] Step 830 , the operating mandrel 220 continues to move from the distal end to the proximal end, so that the first connecting portion 221 and the second connecting portion 130 are released, and the clip device 100 is released.

[0194] In some embodiments, the clip device 10 further includes a connecting pin 230, through which the receiving tube 120 and the sheath tube 210 can be releasably connected, and the distal end of the core shaft 220 includes an actuating portion 227. After the clip device 100 is locked, the operating device 300 operates the core shaft 220 to move from the distal end to the proximal end, and the actuating portion 227 actuates the connecting pin 230 to deform and / or displace, so that the receiving tube 120 and the sheath tube 210 are released.

[0195] The beneficial effects that may be brought about by the embodiments of the present application include but are not limited to:

[0196] (1) When the blocking portion and the blocked portion are engaged, the two clips can be opened or closed freely. When the blocking portion and the blocked portion are released from engagement, the proximal ends of the two clips can be deformed or displaced radially outward and locked with the storage tube. The entire locking process occurs by the automatic deformation of the proximal ends of the clips, thereby reducing the locking operation.

[0197] (2) After the proximal end of the clip is matched with the receiving tube, the receiving tube can limit the axial displacement and radial displacement of the proximal end of the clip, thereby improving the locking stability of the clip.

[0198] (3) Before and when the clip is locked, the first connection part is connected to the second connection part, and after the clip is locked, the first connection part is released from the second connection part, making the operation more precise and reliable, reducing the possibility of misoperation, and improving the safety of surgical operations.

[0199] (4) The blocking part and the blocked part are released from constraint by axial relative displacement. Thus, the release timing of the blocking part and the blocked part can be precisely controlled by the axial movement of the core shaft. The operation is simple and quick, ensuring that the clamp device is accurately released when needed, thereby improving the accuracy of the surgical operation.

[0200] (5) The pre-tightening portion of the side wing is configured to provide a pre-tightening force to the proximal end of the clip, and the pre-tightening force presses the proximal end of the clip against the first connecting portion. When the clip makes axial movement in an unlocked state, it can prevent the proximal end of the clip from accidentally falling out of the gap between the side wing and the first connecting portion, thereby avoiding unexpected situations such as premature self-locking of the clip or locking failure.

[0201] (6) The structure and size of the first connection part are optimized, especially the size design of the first deformation zone and the second deformation zone is optimized, so that the first force and the second force can cause these areas to deform within a reasonable range, which is conducive to controlling the motion state of the connecting shaft. At the same time, the first deformation zone and the second deformation zone undergo a more reasonable deformation when subjected to a predetermined force, avoiding structural fracture caused by excessive deformation, reducing the generation of fragments, and improving surgical safety.

[0202] (7) By setting the blocking part and the blocked part as sliding constraints, the clip is constrained within a specific travel range, which is conducive to controlling the locking process of the clip through the movement range of the clip, rather than relying on the force of the core shaft, making the operation simpler and more intuitive, and reducing the risk of misoperation.

[0203] (8) The locking portion and the locked portion form a limiting fit inside the storage tube to prevent the locked portion from protruding from the side wall of the storage tube, making the structure more compact.

[0204] (9) The first limiting groove and the second limiting groove are both arranged on the central axis of the core shaft, and the entire movement path of the connecting shaft is along the central axis of the core shaft, thereby reducing structural vibration and improving stability.

[0205] (10) By providing the slots, the movement angle of the clamp is increased, so that the clamp has a larger span when in the open state, which is conducive to clamping larger wounds or tissues.

[0206] (11) The limiting structure is arranged at an angle relative to the axis of the storage tube. When the storage tube and the clip are in a locked state and the distance from the proximal end of the storage tube to the distal end of the clip remains unchanged, the clip has a larger range of motion in the position of the limiting structure, thereby increasing the span of the clip.

[0207] 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 beneficial effects that may be obtained.

[0208] The basic concepts have been described above. Obviously, for those skilled in the art, the above detailed disclosure is only for example and does not constitute a limitation of this specification. Although not explicitly stated here, those skilled in the art may make various modifications, improvements and corrections to this specification. Such modifications, improvements and corrections are suggested in this specification, so such modifications, improvements and corrections still belong to the spirit and scope of the exemplary embodiments of this specification.

[0209] It should be noted that in order to simplify the description disclosed in this specification and thus help understand one or more embodiments, in the above description of the embodiments of this specification, multiple features are sometimes combined into one embodiment, figure or description thereof. However, this disclosure method does not mean that the features required by the subject of this specification are more than the features mentioned in the claims. In fact, the features of the embodiments are less than all the features of the single embodiment disclosed above.

[0210] In some embodiments, numbers describing the number of components and attributes are used. 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 specified, "about", "approximately" or "substantially" indicate that the numbers are allowed to vary by ±20%. Accordingly, in some embodiments, the numerical parameters used in the specification and claims are approximate values, which may change according to the required features 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 setting of such numerical values ​​is as accurate as possible within the feasible range.

[0211] Finally, it should be understood that the embodiments described in this specification are only used to illustrate the principles of the embodiments of this specification. Other variations may also fall within the scope of this specification. Therefore, as an example and not a 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 introduced and described in this specification.

Claims

1. A clamp device, characterized in that: include: The delivery device comprises a sheath tube and a core shaft disposed in the sheath tube, wherein the distal end of the core shaft comprises a first connecting portion; A clip device, comprising at least two clips, a receiving tube and a second connecting portion, wherein the receiving tube is disposed at the distal end of the sheath tube, the proximal end of the clip is axially movably disposed in the receiving tube, the clip comprises a blocking portion, and the clip and the core shaft are releasably connected via the first connecting portion and the second connecting portion; a blocking portion configured to control the state of the proximal end of the clip by acting on the blocked portion in a radial direction; Wherein, the clamp device includes an unlocked state, a locked state and a released state: In the unlocked state, the blocking portion is configured to constrain the obstructed portion radially inwardly so that the radial gap between the proximal end of the clip and the receiving tube is within a preset range, and the first connecting portion is connected to the second connecting portion; In the locked state, the blocking portion and the blocked portion are released from constraints, so that the proximal end of the clip is deformed or displaced radially outward to cooperate with the receiving tube, and the first connecting portion is connected to the second connecting portion; In the released state, the first connection portion is disconnected from the second connection portion.

2. The clamp device according to claim 1, characterized in that: The blocking portion is arranged at the distal end of the core shaft, and the blocking portion and the blocked portion are released from constraint by axial relative displacement; The storage tube includes a limiting portion, and the clamp device includes a matching portion. When the clamp moves from the distal end to the proximal end so that the matching portion abuts against the limiting portion, the limiting portion restricts the clamp from moving from the distal end to the proximal end, and the core shaft continues to move toward the proximal end, causing axial relative displacement between the blocking portion and the obstructed portion.

3. The clamp device according to claim 1 or 2, characterized in that: The blocking portion includes two side wings, which are respectively located on both sides of the first connecting portion and are used to press the proximal end of the clip onto the first connecting portion; The side wing includes a main body and a pre-tightening portion, the proximal end of the main body is fixed to the distal end of the core shaft, the distal end of the main body is connected to the pre-tightening portion, and the pre-tightening portion is configured to provide a pre-tightening force to the proximal end of the clip, and the pre-tightening force forms a first preset angle between the proximal end of the clip and the first connecting portion.

4. The clip device according to claim 1, characterized in that: The blocking portion is disposed in the receiving tube and protrudes radially inward, and the blocking portion is configured to contact the blocked portion to form a sliding constraint after the at least two clips are closed; The clip comprises a release hole, and the release hole is located at the distal end of the obstructed portion. When the blocking portion slides from the obstructed portion to the release hole, the blocking portion and the obstructed portion are released from constraint.

5. The clip device according to claim 4, characterized in that: The blocking portion includes at least two tube arms, and the at least two tube arms are arranged corresponding to the at least two clips respectively. The distal ends of the tube arms are connected to the storage tube, and the proximal ends protrude from the inner wall of the storage tube.

6. The clip device according to claim 1, characterized in that: The receiving tube includes a locking portion, and the clip includes a locked portion. After the blocking portion and the blocked portion are released from constraints, the proximal end of the clip is deformed or displaced radially outward so that the locking portion cooperates with the locked portion.

7. The clip device according to claim 6, characterized in that The locking portion and the locked portion form a limiting fit on the side wall of the storage tube; The locking portion includes a first recessed portion provided on the side wall of the storage tube, and the locked portion includes a first protruding portion provided on the proximal end of the clip and protruding radially outward, the first recessed portion cooperates with the first protruding portion, and the clip device is locked.

8. The clip device according to claim 6, characterized in that: The locking portion and the locked portion form a limited fit inside the storage tube; The locking portion includes a second convex portion provided on the side wall of the receiving tube and protruding radially inward, and the locked portion includes a second concave portion provided on the clip, and the second concave portion cooperates with the second convex portion, so that the clip device is locked.

9. The clip device according to claim 1, characterized in that: The first connection portion includes a first limiting groove and a second limiting groove, and in the unlocked state, the first limiting groove is connected to the second connection portion; When the core shaft moves from the distal end to the proximal end, the first limiting groove is deformed or displaced due to the first force and is released from the second connecting portion, so that the second limiting groove is connected to the second connecting portion, and the blocking portion and the blocked portion are axially relatively displaced and are released from the constraint; When the core shaft continues to move from the distal end to the proximal end, the second limiting groove is deformed or displaced due to the second force and is released from the second connecting portion, and the first connecting portion and the second connecting portion are released.

10. The clip device according to claim 1, characterized in that: The receiving tube comprises two slots respectively arranged corresponding to the clips, the slots are arranged at the distal end of the receiving tube, and the slots are configured to provide the clips with an additional range of motion; and / or, The storage tube includes a limiting structure arranged at its distal end, and the limiting structure is configured to limit the distal movement of the clip when the clip is opened; the range of the fifth preset angle between the limiting structure and the axis of the storage tube includes 40° to 90°.

11. The clip device according to claim 1, characterized in that: The clamp instrument also includes a connecting pin, and the storage tube and the sheath tube are releasably connected through the connecting pin. The distal end of the core shaft includes an actuating portion, and the connecting pin is configured as follows: after the clamp device is locked, the core shaft moves from the distal end to the proximal end, and the actuating portion actuates the connecting pin to deform and / or displace, thereby releasing the storage tube and the sheath tube.

12. The clip device according to claim 1, characterized in that The first connecting portion is located between the proximal ends of the at least two clips.

13. The clip device according to claim 1, characterized in that: The first connecting portion includes two connecting hooks, and the second connecting portion is a connecting hole arranged at the proximal end of each of the clips; In the unlocked state, the two connecting hooks are respectively matched with the connecting holes of the two clips, and the first connecting part is connected to the second connecting part; In the locked state, the connecting hook is deformed or displaced for the first time due to the first force, so that the connecting hook remains in cooperation with the connecting hole, and the proximal end of the clip is deformed or displaced radially outward to cooperate with the receiving tube; In the release state, the connecting hook is deformed or displaced for a second time due to the second force, so that the connecting hook is released from the connecting hole, and the first connecting part and the second connecting part are released.

14. The clip device according to claim 13, characterized in that The two connecting hooks constitute the blocking portion, the proximal ends of the at least two clips are located between the two connecting hooks, and the two connecting hooks act on the proximal ends of the clips radially inwardly.

15. A clamp device, characterized in that: include: The delivery device comprises a sheath tube and a core shaft disposed in the sheath tube, wherein the distal end of the core shaft comprises a first connecting portion; A clip device, comprising at least two clips, a receiving tube and a second connecting portion, wherein the receiving tube is arranged at the distal end of the sheath tube, the clip and the core shaft are releasably connected through the first connecting portion and the second connecting portion, and the clip device comprises an unlocked state, a locked state and a released state; Wherein, in the unlocked state, the first connecting portion and the second connecting portion form a first matching state, and the proximal end of the clip is axially movable in the receiving tube; In the locked state, the first connecting portion is deformed or displaced due to the first force, and forms a second matching state with the second connecting portion, and the proximal end of the clip is locked with the storage tube; In the released state, the first connection portion is deformed or displaced due to the second force, and is released from the second connection portion, and the core shaft is released from the clip.

16. The clip device according to claim 15, characterized in that The first connection portion includes a first limiting groove and a second limiting groove, and the second connection portion includes a connecting shaft; In the unlocked state, the first limiting groove is connected to the connecting shaft; When the core shaft moves from the distal end to the proximal end, the first limiting groove is deformed or displaced due to the first force and is released from the connection shaft, so that the second limiting groove is connected to the connection shaft, and the clamp device enters a locked state; When the core shaft continues to move from the distal end to the proximal end, the second limiting groove is deformed or displaced due to the second force and is released from the connecting shaft, and the first connecting portion and the second connecting portion are released.

17. The clip device according to claim 16, characterized in that The first limiting groove is located at the proximal end of the first connecting portion and is arranged on the central axis of the core shaft, and the second limiting groove is located at the distal end of the first connecting portion and is offset relative to the central axis of the core shaft.

18. The clip device of claim 17, wherein: The third preset angle between the opening direction of the first limiting groove and the opening direction of the second limiting groove ranges from 90° to 180°; The range of the fourth preset angle between the opening direction of the first limiting groove and the central axis of the core shaft includes 40° to 90°.

19. The clip device of claim 17, wherein: The first limiting groove is configured to completely accommodate the connecting shaft, and the second limiting groove is configured to at least partially accommodate the connecting shaft; The opening size of the first limiting groove is smaller than the diameter of the connecting shaft; The opening size of the first limiting groove ranges from 0.1 mm to 0.3 mm.

20. The clip device of claim 17, wherein: The first connecting portion includes a first deformation zone, the first deformation zone is arranged corresponding to the first limiting groove, and is configured to deform under the first force, and the maximum size of the first deformation zone ranges from 0.55 mm to 0.65 mm; The first connecting portion includes a second deformation zone, the second deformation zone is arranged corresponding to the second limiting groove, and is configured to deform under the second force, and the maximum size of the second deformation zone ranges from 0.35 mm to 0.45 mm.

21. The clip device of claim 16, wherein: The first limiting groove and the second limiting groove are both arranged on the central axis of the core shaft.

22. The clip device of claim 21, wherein: A guide channel is formed between the first limiting groove and the second limiting groove, and the guide channel is configured to guide the second connecting portion to enter the second limiting groove after the first limiting groove is deformed; A release opening is formed at the distal end of the second limiting groove, and the release opening is configured to release the second connecting portion after the second limiting groove is deformed.

23. The clip device of claim 22, wherein: The first limiting groove and / or the second limiting groove are hole-shaped grooves, and the aperture range of the first limiting groove and / or the second limiting groove includes 0.5mm to 0.6mm; the width range of the guide channel includes 0.2mm to 0.3mm.

24. The clip device of claim 15, wherein: The first connecting portion includes two connecting hooks, and the second connecting portion is a connecting hole arranged at the proximal end of each of the clips; In the unlocked state, the connecting hook cooperates with the connecting hole in a first predetermined form; When the core shaft moves from the distal end to the proximal end, the connecting hook is deformed or displaced due to the first force, and cooperates with the connecting hole in a second predetermined form, and the clip device enters a locked state; When the core shaft continues to move from the distal end to the proximal end, the connecting hook is deformed or displaced due to the second force, and is released from the connecting hole in a third predetermined form, and the first connecting portion and the second connecting portion are released.

25. The clip device of claim 15, wherein: The force value of the first acting force is smaller than the force value of the second acting force; The force value range of the first acting force includes 20N to 50N; The force value range of the second acting force includes 30N to 60N.

26. The clip device of claim 15, wherein: The first connecting portion has at least one of the following material performance parameters: Tensile strength greater than or equal to 520MPa; Yield strength greater than or equal to 205MPa; Elongation greater than or equal to 40%; Hardness less than or equal to 187N / mm 2 .

27. The clip device of claim 15, wherein: The clip apparatus further comprises a blocking portion, and the clip comprises a blocked portion; In the unlocked state, the blocking portion constrains the obstructed portion radially inwardly, and the radial gap between the proximal end of the clip and the receiving tube is within a preset range; In the locked state, when the first connecting portion and the second connecting portion are converted to the second mating state, the blocking portion and the obstructed portion are directly or indirectly triggered to release the constraints, and the proximal end of the clip is deformed radially outward to cooperate with the receiving tube.

28. The clip device of claim 27, wherein: The receiving tube includes a locking portion, and the clip includes a locked portion. After the blocking portion and the blocked portion are released from constraint, the proximal end of the clip deforms radially outward so that the locking portion cooperates with the locked portion.

29. The clip device of claim 15, wherein: The clamp instrument also includes a connecting pin, and the storage tube and the sheath tube are releasably connected through the connecting pin. The distal end of the core shaft includes an actuating portion, and the connecting pin is configured as follows: after the clamp device is locked, the core shaft moves from the distal end to the proximal end, and the actuating portion actuates the connecting pin to deform and / or displace, thereby releasing the storage tube and the sheath tube.

30. A method for operating a clamp device, characterized in that: The operating method is applied to a clip device according to any one of claims 1 to 29, wherein the clip device includes a blocking portion, and the clip includes a blocked portion, and the operating method includes: The radial gap between the proximal end of the clip and the receiving tube is controlled within a preset range by the blocking portion, the first connecting portion of the mandrel and the second connecting portion of the clamp device have a first matching state, and the mandrel is operated to reciprocate along the sheath channel to drive the clip to open or close; The core shaft is operated to move from the distal end to the proximal end, so that the first connecting portion and the second connecting portion are switched to the second mating state, thereby triggering the blocking portion and the blocked portion to release the constraint, so that the proximal end of the clip is deformed or displaced radially outward to be mated with the receiving tube, and the clip device is locked; The core shaft is operated to continue to move from the distal end to the proximal end, so that the first connecting part and the second connecting part are released, and the clip device is released.

31. The method for operating the clip device according to claim 30, characterized in that: The method of controlling the radial gap between the proximal end of the clip and the receiving tube within a preset range by the blocking portion includes: The blocking portion is arranged at the distal end of the core shaft, the blocked portion is pre-matched with the blocking portion, and when the force between the first connecting portion and the second connecting portion is less than the first acting force, the blocking portion controls the radial clearance between the proximal end of the clip and the receiving tube within a preset range; or, The blocking portion is arranged in the receiving tube and protrudes radially inward. A release hole is provided at the distal end of the blocked portion. The axial movement range of the release hole is between the distal end of the receiving tube and the blocking portion. The blocking portion controls the radial gap between the proximal end of the clip and the receiving tube within a preset range.

32. The method for operating the clip device according to claim 30, characterized in that: The first connecting portion of the mandrel and the second connecting portion of the clamp device have a first mating state, and the first connecting portion and the second connecting portion switch to a second mating state, including: In the first mating state, the first connecting portion includes a first limiting groove and a second limiting groove, and the second connecting portion is pre-matched with the first limiting groove; When the core shaft is operated to move from the distal end to the proximal end and the force between the first connecting part and the second connecting part is equal to the first acting force, the first limiting groove is deformed or displaced due to the first acting force and is released from the second connecting part, so that the second limiting groove and the second connecting part are connected, and the first connecting part and the second connecting part are switched to a second mating state.

33. The method for operating the clip device according to claim 30, characterized in that: The clamp device is locked, comprising: The storage tube includes a locking portion, and the clip includes a locked portion; The blocking portion and the blocked portion are operated to release the constraints, and the proximal end of the clip is deformed or displaced radially outward, so that the locking portion is matched with the locked portion.

34. The method for operating the clip device according to claim 30, characterized in that: The clamp device release comprises: The clip instrument further comprises a connecting pin, through which the receiving tube and the sheath tube are releasably connected, and the distal end of the mandrel comprises an actuating portion; After the clip device is locked, the core shaft is operated to move from the distal end to the proximal end, and the actuating portion actuates the connecting pin to deform and / or displace, thereby releasing the receiving tube and the sheath tube.

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