Clamp instrument

Abstract

The embodiment of the specification provides a clip instrument. 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] This specification relates to the field of medical devices, and particularly to a clip device. Background Art

[0002] In minimally invasive surgery, endoscopic clip devices (e.g., hemostatic clips) are mainly used to clamp human tissues to achieve the purpose of hemostasis and suturing. However, common clip devices are difficult to achieve an effective self-locking function. Therefore, additional operations by doctors are required to ensure that the hemostatic clip can be stably locked in the closed state, increasing the complexity and difficulty of the surgery. Moreover, after the clip device is locked, its post-locking stability is often insufficient, and it is prone to loosening, resulting in poor hemostasis effect or suture failure, and even potentially causing secondary harm to the patient. In addition, the clip device may drop fragments during operation. These residual fragments may not only prevent the smooth disassembly of the head of the hemostatic clip, but also may remain in the patient's body, posing a potential threat to the patient's health. Summary of the Utility Model

[0003] One or more embodiments of this specification provide a clip device, including: a delivery device, including a sheath and a mandrel disposed within the sheath, the distal end of the mandrel including a first connection portion; a clip device, including at least two clip blades, a receiving tube, and a second connection portion, the receiving tube being disposed at the distal end of the sheath, the proximal ends of the clip blades being axially movably disposed within the receiving tube, the clip blades including a blocked portion, and the clip blades and the mandrel being releasably connected through the first connection portion and the second connection portion; a blocking portion configured to control the state of the proximal ends of the clip blades by acting on the blocked portion in the radial direction; wherein, the clip device includes an unlocked state, a locked state, and a released state: in the unlocked state, the blocking portion is configured to radially inwardly constrain the blocked portion, such that the radial gap between the proximal ends of the clip blades and the receiving tube is within a preset range, and the first connection portion is connected to the second connection portion; in the locked state, the blocking portion is disengaged from the blocked portion, such that the proximal ends of the clip blades are radially outwardly deformed or displaced to cooperate with the receiving tube, and the first connection portion is connected to the second connection portion; in the released state, the first connection portion is disconnected from the second connection portion.

[0004] One or more embodiments of the present specification also provide a clip device, including: a delivery device, including a sheath and a mandrel disposed within the sheath, wherein a distal end of the mandrel includes a first connection portion; a clip device, including at least two clip pieces, a receiving tube, and a second connection portion, the receiving tube is disposed at a distal end of the sheath, and the clip pieces and the mandrel are releasably connected through the first connection portion and the second connection portion, and the clip device includes an unlocked state, a locked state, and a released state; wherein, in the unlocked state, the first connection portion and the second connection portion form a first mating state, and a proximal end of the clip piece is axially movably disposed within the receiving tube; in the locked state, the first connection portion is deformed or displaced due to a first acting force, and forms a second mating state with the second connection portion, and the proximal end of the clip piece is locked with the receiving tube; in the released state, the first connection portion is deformed or displaced due to a second acting force, and is disengaged from the second connection portion, and the mandrel is disengaged from the clip piece.

[0005] When the blocking portion cooperates with the blocked portion, the two clip pieces can be freely opened or closed. When the blocking portion is disengaged from the blocked portion, the proximal ends of the two clip pieces can be radially outwardly deformed or displaced and locked with the receiving tube. The entire locking process occurs due to the automatic deformation of the proximal ends of the clip pieces, reducing the locking operation. After the proximal ends of the clip pieces cooperate with the receiving tube, the receiving tube can restrict the axial displacement and radial displacement of the proximal ends of the clip pieces, improving the locking stability of the clip pieces. Before and during the locking of the clip pieces, the first connection portion and the second connection portion are connected. After the clip pieces are locked, the first connection portion is released from the second connection portion, making the operation more precise and reliable, reducing the possibility of misoperation, and improving the safety of the surgical operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] This specification will be further described by way of exemplary embodiments, which will be described in detail through the drawings. These embodiments are not restrictive. In these embodiments, the same numbers represent the same structures, wherein:

[0007] Figure 1 is an exemplary structural diagram of a clip device shown according to some embodiments of this specification;

[0008] Figure 2 is an exemplary structural diagram of a distal structure of a clip device shown according to some embodiments of this specification;

[0009] Figure 3 is according to Figure 2 a cross-sectional view taken along line A-A of the clip device shown;

[0010] Figure 4 is according to Figure 2 an exploded view of the clip device shown;

[0011] Figure 5 is an exemplary structural diagram of the distal end structure of the mandrel shown in some embodiments of this specification;

[0012] Figure 6 is according to Figure 5 a partial enlarged view of region B of the distal end structure of the mandrel shown;

[0013] Figure 7 is a partial enlarged view of the clip and the flank after cooperation shown in some embodiments of this specification;

[0014] Figure 8 is a side view of the distal end structure of the mandrel shown in some embodiments of this specification;

[0015] Figure 9 is an exemplary structural diagram of the clip shown in some embodiments of this specification;

[0016] Figure 10 is an exemplary structural diagram of the receiving tube shown in some embodiments of this specification;

[0017] Figure 11A is the front view of the distal end structure of the mandrel shown in some embodiments of this specification Figure 1 ;

[0018] Figure 11B is the front view of the distal end structure of the mandrel shown in some embodiments of this specification Figure 2 ;

[0019] Figure 12A is a cross-sectional view of the clip device in the unlocked state shown in some embodiments of this specification;

[0020] Figure 12B is according to Figure 12A a cross-sectional view of the clip device taken along line C-C shown;

[0021] Figure 13A is a cross-sectional view of the clip device in the locked state shown in some embodiments of this specification;

[0022] Figure 13B is according to Figure 13A a cross-sectional view of the clip device taken along line D-D shown;

[0023] Figure 14 is a cross-sectional view of the first connecting portion and the second connecting portion in the released state shown in some embodiments of this specification;

[0024] Figure 15 is a cross-sectional view of the receiving tube and the sheath tube in the released state shown in some embodiments of this specification;

[0025] Figure 16 is an exemplary structural diagram of the distal structure of the clip device shown in some embodiments of this specification;

[0026] Figure 17 is an exemplary structural diagram of the storage tube shown in some embodiments of this specification;

[0027] Figure 18 is an exemplary structural diagram of the distal structure of the mandrel shown in some embodiments of this specification;

[0028] Figure 19 is an exemplary structural diagram of the clip shown in some embodiments of this specification;

[0029] Figure 20 is a cross-sectional view of the clip device in the open state shown in some embodiments of this specification;

[0030] Figure 21 is a cross-sectional view of the clip device in the closed state shown in some embodiments of this specification;

[0031] Figure 22 is a cross-sectional view of the clip device in the locked state shown in some embodiments of this specification;

[0032] Figure 23A is a cross-section of the clip device in the released state shown in some embodiments of this specification Figure 1 ;

[0033] Figure 23B is a cross-section of the clip device in the released state shown in some embodiments of this specification Figure 2 ;

[0034] Figure 24 is an exemplary structural diagram of the storage tube shown in some embodiments of this specification;

[0035] Figure 25 is an exemplary structural diagram of the clip shown in some embodiments of this specification;

[0036] Figure 26 is a cross-sectional view of the clip device in the unlocked state shown in some embodiments of this specification;

[0037] Figure 27 is a cross-sectional view of the clip device in the locked state shown in some embodiments of this specification;

[0038] Figure 28A is a schematic structural diagram of the clip device in the released state shown in some embodiments of this specification;

[0039] Figure 28Bis a cross-sectional view taken along line F-F in region E of the clip device shown in Figure 28A ;

[0040] Figure 28C is a cross-sectional view taken along line G-G of the clip device shown in Figure 28B ;

[0041] Figure 29A is an exemplary isometric view of the distal end structure of the mandrel shown in some embodiments of this specification;

[0042] Figure 29B is a Figure 29A exemplary front view of the distal end structure of the mandrel shown;

[0043] Figure 29C is a Figure 29A exemplary side view of the distal end structure of the mandrel shown;

[0044] Figure 30A is the mating state of the first connecting portion and the second connecting portion in the unlocked state shown in some embodiments of this specification;

[0045] Figure 30B is the mating state of the first connecting portion and the second connecting portion during the locking process shown in some embodiments of this specification;

[0046] Figure 30C is the mating state of the first connecting portion and the second connecting portion in the locked state shown in some embodiments of this specification;

[0047] Figure 31A is an exemplary structural diagram of the first predetermined form of the first connecting portion shown in some embodiments of this specification;

[0048] Figure 31B is an exemplary structural diagram of the second predetermined form of the first connecting portion shown in some embodiments of this specification;

[0049] Figure 32 is an exemplary structural diagram of the clip shown in some embodiments of this specification;

[0050] Figure 33 is a cross-sectional view of the clip device in the unlocked state shown in some embodiments of this specification;

[0051] Figure 34 is a cross-sectional view of the clip device in the locked state shown in some embodiments of this specification;

[0052] Figure 35 is a cross-sectional view of the clip device in the released state shown in some embodiments of this specification;

[0053] Figure 36 It is an exemplary structural diagram of the distal structure of the clip instrument shown in some embodiments of this specification;

[0054] Figure 37 It is an exemplary structural diagram of the storage tube shown in some embodiments of this specification;

[0055] Figure 38 It is an exemplary structural diagram of the storage tube shown in some embodiments of this specification;

[0056] Figure 39 It is an exemplary cross-sectional view of the distal structure of the clip instrument shown in some embodiments of this specification;

[0057] Figure 40 It is a flowchart of the operation method of the clip instrument shown in some embodiments of this specification;

[0058] The reference numerals are:

[0059] 10. Clip instrument; 100. Clip device; 110. Clip piece; 111. Distal clamping part; 112. Bending part; 113. Proximal joint part; 114. Assembly hole; 115. Locked part; 116. Release hole; 120. Storage tube; 121. Limiting part; 122. Main body tube; 123. Tail tube; 124. First limiting hole; 125. Locking part; 126. Groove; 127. Limiting structure; 130. Second connecting part; 131. Connecting shaft; 132. Connecting hole; 140. Blocked part; 150. Matching part; 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 part; 2262. Hook part; 2263. First limiting area; 2264. Second limiting area; 2265. First barb; 2266. Second barb; 230. Connecting pin; 231. Tube part; 232. Support arm; 240. Spring end; 300. Operating device; 400. Blocking part; 410. Flank; 411. Body; 412. Pre-tightening part; 413. Reinforcing rib; 414. Welding point; 420. Tube arm. Detailed implementation manners

[0060] To more clearly illustrate the technical solutions of the embodiments of this specification, the following will briefly introduce the accompanying drawings required for the description of the embodiments. Obviously, the accompanying drawings in the following description are only some examples or embodiments of this specification. For those of ordinary skill in the art, without creative efforts, this specification can also be applied to other similar scenarios based on these drawings. Unless obvious from the language context or otherwise stated, the same reference numerals in the drawings represent the same structure or operation.

[0061] As shown in this specification and the claims, unless the context clearly indicates otherwise, words such as "a", "an", "one", and / or "the" are not specifically singular and may also include plural. Generally speaking, the terms "comprising" and "including" only indicate the inclusion of the clearly identified steps and elements, and these steps and elements do not constitute an exclusive list. The method or device may also include other steps or elements.

[0062] 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 previous or subsequent operations are not necessarily executed precisely in sequence. On the contrary, they can be executed in reverse order or simultaneously. At the same time, other operations can also be added to these processes, or one or several operations can be removed from these processes.

[0063] Endoscopic clip instruments are widely used in minimally invasive surgeries, which achieve rapid suture and hemostasis by clamping tissue wounds. Traditional clip instruments require doctors to directly apply operating force to the locking member or clip to achieve locking, which has a certain degree of operating difficulty; in addition, the locking of the clip instrument is unstable, prone to loosening, and some structures are prone to breakage during the operation, resulting in debris generation, affecting the safety of the surgery. In view of this, in some embodiments of this specification, it is desired to provide a clip instrument that simplifies the operation by configuring the proximal end of the clip to automatically spring open for self-locking; and, strengthens the design of some deformable structures to improve the overall stability and reliability.

[0064] The following will elaborate on the technical solutions of the clip instrument through multiple embodiments of this specification, aiming to improve the operation convenience and reliability of the clip instrument in clinical surgeries through some improvement measures. First, it should be noted that various combinations and substitutions 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 the features in other embodiments to obtain better effects. Unless clearly stated as non-replaceable or non-combinable, different embodiments and their features of the present invention can be borrowed and cited from each other to form new embodiments.

[0065] First, this specification will introduce the technical solution of the clip instrument in detail through Example 1.

[0066] Figure 1 It is an exemplary structural diagram of the clip instrument shown in some embodiments of this specification.

[0067] As Figure 1 shown, in some embodiments, the clip instrument 10 includes a clip device 100, a delivery device 200, and an operating device 300. The operating device 300 is disposed at the proximal end of the delivery device 200, and the clip device 100 is disposed at the distal end of the delivery device 200. The "proximal end" and "distal end" involved in the embodiments of this specification can represent directions, which refer to the axial direction of the clip instrument 10 (for example, the extending direction of the sheath 210 of the delivery device 200 in the endoscopic 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"; the "proximal end" and "distal end" can also represent partial structures located in the corresponding directions and should not be understood as only representing the ends.

[0068] In some embodiments, the delivery device 200 includes a sheath 210 and a mandrel 220 disposed within the sheath 210. The mandrel 220 extends along the axial direction of the sheath 210. The proximal end of the mandrel 220 is connected to the operating device 300, and the distal end of the mandrel 220 is connected to the clip device 100. The "axial direction" and "radial direction" involved in the embodiments of this specification can represent directions. The "radial direction" is perpendicular to the "axial direction", or the axial direction is the extending direction of the channel of the sheath 210, and the radial direction is perpendicular to the extending direction of the channel of the sheath 210. The user controls the axial movement of the operating device 300 outside the body to control the axial movement of the mandrel 220 within the channel of the sheath 210, so that the clip device 100 completes corresponding surgical operations, such as opening, closing, locking, releasing and other surgical operations.

[0069] Figure 2 It is an exemplary structural diagram of the distal structure of the clip instrument 10 shown in some embodiments of this specification. Figure 3 is according to Figure 2 shown cross-sectional view of the clip instrument 10 taken along line A-A. Figure 4 is according to Figure 2 shown exploded view of the clip instrument 10.

[0070] As Figures 2 to 4 shown, Embodiment 1 of this specification provides a clip instrument 10, including a clip device 100, a delivery device 200, and a blocking portion 400.

[0071] In some embodiments, the distal end of the mandrel 220 of the conveying device 200 includes a first connection portion 221 for connecting the clip device 100, so that the mandrel 220 controls the movement of the clip device 100 through axial movement.

[0072] In some embodiments, the clip device 100 includes at least two clip pieces 110, a receiving tube 120, and a second connection portion 130. The receiving tube 120 is provided at the distal end of the sheath tube 210. The proximal ends of the clip pieces 110 are axially movably provided within the receiving tube 120. The clip pieces 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 releasing of the clip pieces 110 through axial movement. In some embodiments, the clip pieces 110 include a blocking portion 140 provided at the proximal end of the clip pieces 110 or at a position close to the proximal end.

[0073] In some embodiments, the blocking portion 400 is configured to control the state of the proximal end of the clip pieces 110 by acting radially on the blocking portion 140. Wherein, the state of the proximal end of the clip pieces 110 includes a state in which the proximal ends of the two clip pieces 110 approach and converge with each other, and a state in which they are separated from each other. In some embodiments, the blocking portion 400 is provided at the distal end of the mandrel 220. For example, the blocking portion 400 includes, but is not limited to, a flank 410 (as Figure 5 shown), a tube arm 420 (as Figure 17 shown), or a connecting hook 226 (as Figure 31A and Figure 31B shown). The flank 410, the tube arm 420, or the connecting hook 226 are releasably engaged with the blocking portion 140. In some other embodiments, the blocking portion 400 is provided on the inner wall of the receiving tube 120, and the blocking portion 140 is in sliding contact with the blocking portion 400 within a preset stroke range. More detailed embodiments of the blocking portion 400 will be described in Figure 5 、 Figure 6 、 Figures 16 to 19 .

[0074] In some embodiments, the clip device 100 includes an unlocked state, a locked state, and a released state:

[0075] In the unlocked state, the blocking portion 400 is configured to radially inwardly constrain the blocking portion 140, so that the radial gap between the proximal ends of the clip pieces 110 and the receiving tube 120 is within a preset range. At this time, the proximal ends of the two clip pieces 110 approach each other and are in a converged state. Among them, the preset range can be set according to the internal structure and its own 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, and so on. And, the first connection portion 221 is connected to the second connection portion 130, and the mandrel 220 can control the clip pieces 110 to repeatedly open and close, and the clamping situation of the tissue can be flexibly adjusted in actual applications.

[0076] In the locked state, the blocking portion 400 and the blocked portion 140 are disengaged, causing the proximal end of the clip 110 to deform or displace radially outward to cooperate with the receiving tube 120, so that the proximal ends of the clips 110 are in a deployed state away from each other, and restricting the axial movement of the clip 110 relative to the receiving tube 120, locking the clip 110 within the receiving tube 120. Moreover, the first connecting portion 221 is connected to the second connecting portion 130. At this time, since the clip 110 and the receiving tube 120 are locked, the mandrel 220 can no longer control the opening of the clip 110.

[0077] In the released state, the first connecting portion 221 and the second connecting portion 130 are disconnected, and the mandrel 220 and the clip 110 are released.

[0078] 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 bending portion 112, and a proximal coupling portion 113. The proximal coupling portion 113 is movably disposed within the receiving tube 120, and the bending portion 112 is elastic. In the open state, when the mandrel 220 moves from the proximal end to the distal end, the proximal coupling portion 113 pushes the bending portion 112 to extend out of the receiving tube 120, and the bending portion 112 is in a natural bending state, causing the distal clamping portions 111 to move away from each other and open; in the closed state, when the mandrel 220 moves from the distal end to the proximal end, the proximal coupling portion 113 pulls the bending portion 112 to retract into the receiving tube 120, and the bending portion 112 is compressed by the receiving tube 120, causing the distal clamping portions 111 to move closer to each other and close.

[0079] According to the clip instrument 10 in some of the above embodiments, when the blocking portion 400 cooperates with the blocked portion 140, the two clips 110 can be freely opened or closed. When the blocking portion 400 is disengaged from the blocked portion 140, the proximal ends of the two clips 110 can deform or displace radially outward and lock with the receiving tube 120. The entire locking process occurs due to the automatic deformation of the proximal ends of the clips 110, reducing the locking operation. After the proximal ends of the clips 110 cooperate with the receiving tube 120, the receiving tube 120 can restrict the axial and radial displacements of the proximal ends of the clips 110, improving the locking stability of the clips 110. Moreover, before and when the clips 110 are locked, the first connecting portion 221 and the second connecting portion 130 are connected. After the clips 110 are locked, the first connecting portion 221 is only disconnected from the second connecting portion 130, making the operation more precise and reliable, reducing the possibility of misoperation, and improving the safety of the surgical operation.

[0080] As Figure 3 shown, the first connecting portion 221 is located between the proximal ends of at least two clips 110, avoiding interference of the first connecting portion 221 with the radial movement of the proximal ends of the clips 110.

[0081] In some embodiments, the blocking portion 400 is provided at the distal end of the mandrel 220. The blocking portion 400 and the blocked portion 140 are released from the constraint by an axial relative displacement. In this way, the release timing of the blocking portion 400 and the blocked portion 140 can be precisely controlled by the axial movement of the mandrel 220. The operation is simple and fast, ensuring the accurate release of the clip device 100 when needed and improving the accuracy of the surgical operation.

[0082] In some embodiments, the receiving tube 120 includes a limiting portion 121, and the clip device 100 includes a mating portion 150. When the clip 110 moves from the distal end to the proximal end and the mating portion 150 abuts against the limiting portion 121, the limiting portion 121 restricts the clip 110 from moving from the distal end to the proximal end. When the mandrel 220 continues to move proximally, an axial relative displacement occurs between the blocking portion 400 and the blocked portion 140. In some embodiments, the limiting portion 121 is provided at or near the proximal end of the receiving tube 120 and protrudes radially inwardly, such as an annular protrusion or a dot-like protrusion. In some embodiments, the receiving tube 120 includes a main body 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 body tube 122. The distal end of the tail tube 123 and the inner wall of the main body tube 122 form a step, and this 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 the mating portion 150.

[0083] Figure 5 It is an exemplary structural diagram of the distal end structure of the mandrel 220 shown in some embodiments of this specification. Figure 6 is according to Figure 5 shown, a partial enlarged view of region B of the distal end structure of the mandrel 220. Figure 7 It is a partial enlarged view of the clip 110 and the flank 410 after cooperation shown in some embodiments of this specification. Figure 8 It is a side view of the distal end structure of the mandrel 220 shown in some embodiments of this specification.

[0084] As Figures 5 to 6 shown, the blocking portion 400 includes two flanks 410. The two flanks 410 are respectively located on both sides of the first connecting portion 221 and are used to press the proximal ends of the clips 110 against the first connecting portion 221. In some embodiments, the proximal ends of the flanks 410 are fixed to the mandrel 220 or the first connecting portion 221. There is a gap between the distal ends of the flanks 410 and the first connecting portion 221. The blocked portions 140 at the proximal ends of the two clips 110 respectively extend into the gaps on both sides of the first connecting portion 221, and the flanks 410 can radially limit the proximal ends of the two clips 110 on both sides of the first connecting portion 221.

[0085] In some embodiments, reinforcing ribs 413 and / or welding points 414 are provided on the wing 410 to increase the strength of the wing 410 and prevent the proximal limit of the clip 110 from failing due to accidental breakage or deformation of the wing 410.

[0086] 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, and the distal end of the body 411 is connected to the pre-tightening portion 412. The pre-tightening portion 412 is configured to provide a pre-tightening force to the proximal end of the clip 110. This pre-tightening force presses the proximal end of the clip 110 against the first connecting portion 221. When the clip 110 moves axially in the unlocked state, it can prevent the proximal end of the clip 110 from accidentally slipping out of the gap between the wing 410 and the first connecting portion 221, avoiding accidental situations such as premature self-locking or locking failure of the clip 110. In some embodiments, the pre-tightening portion 412 can be formed by bending the distal end of the body 411 by a certain angle. In some other embodiments, the distal end of the body 411 includes an elastic protrusion protruding towards the first connecting portion 221, and this elastic protrusion is configured as the pre-tightening portion 412.

[0087] As Figure 7 shown, in some embodiments, the pre-tightening force generated by the pre-tightening portion 412 on the clip 110 causes a first preset angle α to be formed between the proximal end of the clip 110 and the first connecting portion 221. Exemplarily, the range of the first preset angle α is 0 to 10°, and preferably, the first preset angle α is about 5°. By designing an appropriate wing 410 and pre-tightening force, the wing 410 has sufficient pre-tightening force on the proximal end of the clip 110 to ensure that the clip 110 can maintain an appropriate position and stability in the working state. This angle design also enables the distal end of the clip 110 to form a sufficient span, thereby effectively clamping the target tissue.

[0088] As Figure 8 shown, in some embodiments, the pre-tightening portion 412 of the wing 410 is formed by bending the distal end of the body 411 towards the first connecting portion 221 by a certain angle. A second preset angle β is formed at the connection between the pre-tightening portion 412 and the body 411, and the second preset angle β is arranged facing the direction of the first connecting portion 221. Exemplarily, the range of the second preset angle is 150° to 180°, and preferably, the second preset angle β is about 160°. In this angle range, the pre-tightening force of the wing 410 on the blocking portion 140 of the clip 110 is within a suitable range, which can not only ensure the cooperation stability between the clip 110 and the wing 410 in the unlocked state and prevent accidental detachment, but also ensure that it can be smoothly disengaged from the wing 410 during locking to prevent the situation of being unable to separate.

[0089] Figure 9 is an exemplary structural diagram of the clip 110 shown according to some embodiments of this specification. Figure 10It is an exemplary structural diagram of the storage tube 120 shown in some embodiments of this specification.

[0090] As Figure 9 and Figure 10 shown, in some embodiments, the storage tube 120 includes a locking portion 125, the clip 110 includes a locked portion 115, after the blocking portion 400 is released from the constrained portion 140, the proximal end of the clip 110 deforms or displaces radially outward such that the locking portion 125 cooperates with the locked portion 115.

[0091] In some embodiments, when the clip 110 is in the closed state, the bending portion 112 retracts into the storage tube 120 and generates elastic compression. After the blocking portion 400 is released from the constrained portion 140, under the action of the elastic restoring force, the bending portion 112 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.

[0092] In some embodiments, the locking portion 125 and the locked portion 115 form a limit fit on the side wall of the storage tube 120. In some embodiments, the locking portion 125 includes a first recess provided on the side wall of the storage tube 120, and the locked portion 115 includes a first protrusion provided at the proximal end of the clip 110 and protruding radially outward. The first recess cooperates with the first protrusion, and the clip device 100 is locked. In some embodiments, the first recess includes but is not limited to a groove, a hole, etc. For example, the first recess may be a groove formed on the side wall of the storage tube 120, and the groove extends along the circumferential direction of the storage tube 120 and has a certain length to facilitate the accurate fitting of the first protrusion into the groove. The first protrusion includes but is not limited to a protrusion, a flanging, a hook structure, etc. For example, the first protrusion is formed on one of the side edges at the proximal end of the clip 110 and protrudes radially outward, where 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 setting the cooperation of the first recess and the first protrusion, the clip 110 and the storage tube 120 are limited in both the axial and radial directions, improving the locking stability.

[0093] In some embodiments, when the constrained portion 140 of the clip 110 cooperates with the flank 410, the locked portion 115 of the clip 110 forms an abutting limit with the flank 410, which can prevent the clip 110 from swinging radially and causing misalignment during closing.

[0094] As Figure 5As shown, the first connecting portion 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 connecting portion 130. When the mandrel 220 moves from the distal end to the proximal end, the first limiting groove 222 is deformed or displaced due to the first acting force and is disengaged from the second connecting portion 130, so that the second limiting groove 223 is connected to the second connecting portion 130, and the blocking portion 400 and the blocked portion 140 undergo an axial relative displacement to release the constraint. When the mandrel 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 acting force and is disengaged from the second connecting portion 130, and the first connecting portion 221 and the second connecting portion 130 are released. Through the first deformation or displacement of the first connecting portion 221, the clip device 100 is locked. Through the second deformation or displacement of the first connecting portion 221, the mandrel 220 and the clip 110 are released. In this way, the operation is made more accurate and reliable, the situation of misoperation is reduced, and the safety of the operation is improved. For more exemplary embodiments of the first connecting portion 221, reference can be made to Figure 11A , Figure 11B , Figure 18 , Figures 29A to 29C , Figure 31A , Figure 31B and its related descriptions, which will not be elaborated in this specification.

[0095] In some embodiments, the receiving tube 120 includes a limiting structure 127 provided at its distal end. 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 protruding or disengaging from the receiving tube 120 excessively. In some embodiments, the limiting structure 127 is arranged perpendicular to the axis of the receiving tube 120.

[0096] As Figures 1 to 5 shown, some embodiments of this specification further provide a clip instrument 10, which includes a delivery device 200 and a clip device 100.

[0097] In some embodiments, the delivery device 200 includes a sheath tube 210 and a mandrel 220 disposed within the sheath tube 210. The distal end of the mandrel 220 includes a first connecting portion 221. The clip device 100 includes at least two clips 110, a receiving tube 120, and a second connecting portion 130. The receiving tube 120 is disposed at the distal end of the sheath tube 210. The clips 110 and the mandrel 220 are releasably connected through the first connecting portion 221 and the second connecting portion 130. The clip device 100 includes an unlocked state, a locked state, and a released state. For more embodiments here, reference can be made to Figures 1 to 4 and its related descriptions, which will not be elaborated in this specification.

[0098] In the unlocked state, the first connecting portion 221 and the second connecting portion 130 form a first mating state, and the proximal end of the clip 110 is axially movably disposed within the receiving tube 120. In the locked state, the first connecting portion 221 is deformed or displaced due to a first acting force, and forms a second mating state with the second connecting portion 130, and the proximal end of the clip 110 is locked with the receiving tube 120. Among them, the first mating state and the second mating state include, but are not limited to: different portions of the first connecting portion 221 mating with the second connecting portion 130, and / or the first connecting portion 221 mating with the second connecting portion 130 in different deformed configurations. In some embodiments, when the clip device 100 is in the locked state, that is, during the process of the first connecting portion 221 and the second connecting portion 130 switching to the second mating state, it can directly or indirectly trigger the release of the constraint between the blocking portion 400 and the blocked portion 140, and the proximal end of the clip 110 is deformed radially outward to cooperate with the receiving tube 120.

[0099] In the released state, the first connecting portion 221 is deformed or displaced due to a second acting force, and is disengaged from the second connecting portion 130, and the mandrel 220 is disengaged from the clip 110.

[0100] According to the clip instrument 10 in the above solution, the first connecting portion 221 and the second connecting portion 130 have a first mating state. Under the first acting force, the first connecting portion 221 and the second connecting portion 130 are switched to the second mating state, and the clip device 100 is locked. Under the second acting force, the first connecting portion 221 and the second connecting portion 130 are released. This method of controlling the clip device 100 to step into different states through the first acting force and the second acting force not only ensures the reliable self-locking of the clip device 100, but also enables the operation of the clip device 100 to be more accurate and reliable, reduces misoperation, and improves the surgical safety.

[0101] Figure 11A is a front view of the distal structure of the mandrel 220 shown in some embodiments of this specification Figure 1 。 Figure 11B is a front view of the distal structure of the mandrel 220 shown in some embodiments of this specification Figure 2 。

[0102] Such as Figure 5 、 Figure 7 and Figure 9 shown, in some embodiments, the first connecting portion 221 includes a first limiting groove 222 and a second limiting groove 223, and the second connecting portion 130 includes a connecting shaft 131; the proximal ends of the two clips 110 include assembly holes 114, and the assembly holes 114 are movably engaged with the connecting shaft 131. Among them, the assembly holes 114 can axially move relative to the connecting shaft 131, so that the proximal ends of the clips 110 can radially approach or move away from each other relative to the receiving tube 120.

[0103] 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 mandrel 220 drives the connecting shaft 131 to move axially along the receiving tube 120 through the first connecting portion 221.

[0104] When the mandrel 220 moves from the distal end to the proximal end, the first limiting groove 222 is deformed or displaced due to the first acting force and is disengaged from the connecting shaft 131, so that the second limiting groove 223 is connected to the connecting shaft 131, and the clip device 100 enters the locked state. Wherein, when the connecting shaft 131 moves to abut against the limiting portion 121 of the receiving tube 120, the connecting shaft 131 no longer moves proximally. At this time, the mandrel 220 continues to move proximally, so that when the force between the first limiting groove 222 and the connecting shaft 131 reaches the first acting force, the first limiting groove 222 is deformed or displaced, so that the connecting shaft 131 disengages from the first limiting groove 222 and forms a fit 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 blocking portion 140 of the clip 110 to disengage from the side wing 410. The proximal end of the clip 110 is deformed radially outward and forms a lock with the receiving tube 120.

[0105] When the mandrel 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 acting force and is disengaged from the connecting shaft 131, and the first connecting portion 221 and the second connecting portion 130 are released. Wherein, after the clip device 100 is locked, the mandrel 220 continues to move from the distal end to the proximal end. Since the connecting shaft 131 is abutted by the limiting portion 121 and cannot continue to move proximally, when the force between the second limiting groove 223 and the connecting shaft 131 increases to the second acting force, the second limiting groove 223 is deformed or displaced, so that the connecting shaft 131 is disengaged from the second limiting groove 223.

[0106] As Figure 11A and Figure 11B shown, the first limiting groove 222 is located at the proximal end of the first connecting portion 221 and is provided on the central axis of the mandrel 220. 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 disengages from the first limiting groove 222, it can accurately fit into the second limiting groove 223 to ensure the control accuracy. In some embodiments, the first limiting groove 222 is provided on the central axis of the mandrel 220, which means that the geometric center point of the first limiting groove 222 is provided 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.

[0107] In some embodiments, the range of the third preset angle γ between the opening directions of the first limiting groove 222 and the second limiting groove 223 includes 90° to 180°. In this way, after the first limiting groove 222 is deformed, it can be automatically calibrated with the second limiting groove 223 to ensure that the connecting shaft 131 can be accurately docked with the second limiting groove 223, realizing step-by-step control of locking and releasing. Among them, the opening direction refers to the direction of 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 groove opening and pointing to the outside of the first limiting groove 222 (or the second limiting groove 223). In some embodiments, the third preset angle γ is about 125°. In this way, the first connecting portion 221 only undergoes elastic deformation without fracture, reducing the generation of debris and improving surgical safety; and the force value of the first connecting portion 221 can meet the target requirements, thus ensuring the safety and stability during the operation; and, through optimized design, the increase in the axial dimension of the first connecting portion 221 after deformation is minimized, and through unilateral force application, the finally deformed first connecting portion 221 can be smoothly retracted into the sheath 210.

[0108] In some embodiments, the range of the fourth preset angle θ between the opening direction of the first limiting groove 222 and the central axis of the mandrel 220 includes 40° to 90°. Preferably, the fourth preset angle θ is about 55°. In this way, it can not only ensure that the connecting shaft 131 accurately cooperates with the second limiting groove 223 after being disengaged from the first limiting groove 222, but also reduce the risk of fracture of the first limiting groove 222 and reduce the generation of debris.

[0109] In some embodiments, the second connecting portion 130 includes a connecting shaft 131, and the first limiting groove 222 is configured to completely accommodate the connecting shaft 131. For example, the shape and size of the first limiting groove 222 can be adapted to the cross-section of the connecting shaft 131 to ensure the connection stability between the first connecting portion 221 and the second connecting portion 130. In some embodiments, the opening size of the first limiting groove 222 is smaller than the diameter of the connecting shaft 131 to prevent the connecting shaft 131 from disengaging from the undeformed first limiting groove 222. In some embodiments, the range of the opening size L1 of the first limiting groove 222 includes 0.1 mm to 0.3 mm. Preferably, the opening size L1 of the first limiting groove 222 can be about 0.2 mm. In this way, it can not only ensure the cooperation stability between the connecting shaft 131 and the first limiting groove 222, but also prevent the connecting shaft 131 from disengaging from the opening of the undeformed first limiting groove 222.

[0110] 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; alternatively, the second limiting groove 223 can only accommodate a part of the connecting shaft 131. The second limiting groove 223 mainly plays a temporary blocking role on the connecting shaft 131, and it is not necessary to completely snap the connecting shaft 131 into the second limiting groove 223. Therefore, the overall size of the second connecting groove can be relatively small to reduce the radial size of the first connecting portion 221, so that it can smoothly retract into the sheath 210 after deformation.

[0111] In some embodiments, the first connecting portion 221 includes a first deformation region, which is arranged corresponding to the first limiting groove 222 and is configured to deform under a first acting force. Among them, the first deformation region can be a part that can deform around the first limiting groove 222 when the first limiting groove 222 is stressed.

[0112] In some embodiments, the first deformation region has a larger size than other regions around the first limiting groove 222. The range of the maximum size L2 of the first deformation region includes 0.55 mm to 0.65 mm; preferably, the maximum size L2 of the first deformation region is about 0.6 mm.

[0113] In some embodiments, the first connecting portion 221 includes a second deformation region, which is arranged corresponding to the second limiting groove 223 and is configured to deform under a second acting force. Among them, the second deformation region can be a part that can deform around the second limiting groove 223 when the second limiting groove 223 is stressed.

[0114] In some embodiments, the second deformation region has a larger size than other regions around the second limiting groove 223. The range of the maximum size L3 of the second deformation region includes 0.35 mm to 0.45 mm. Preferably, the maximum size L3 of the second deformation region is about 0.4 mm.

[0115] As Figure 8 shown, in some embodiments, the range of the thickness L4 of the first connecting portion 221 includes 0.15 mm to 0.3 mm. Preferably, the thickness L4 of the first connecting portion 221 is about 0.2 mm.

[0116] By optimizing the structure and size of the first connecting portion 221 as described above, especially optimizing the size design of the first deformation region and the second deformation region, the first acting force and the second acting force can cause these regions to deform within a reasonable range, which is beneficial to controlling the movement state of the connecting shaft 131. At the same time, the first deformation region and the second deformation region undergo relatively reasonable deformation when subjected to a predetermined acting force, avoiding structural fracture caused by excessive deformation, reducing debris generation, and improving surgical safety.

[0117] In some embodiments, the first limiting groove 222 is deformed under the first acting force, and the second limiting groove 223 is deformed under the second acting force. The value of the first acting force is less than that of the second acting force. In this way, after the first limiting groove 222 is deformed and separated from the connecting shaft 131 under the first acting force, the core shaft 220 causes the second limiting groove 223 to be deformed and separated from the connecting shaft 131 only after a greater second acting force is applied, which is beneficial to controlling the deformation timing of the first limiting groove 222 and the second limiting groove 223 respectively by forces of different magnitudes, and improving the control accuracy and precision.

[0118] In some embodiments, the value range of the first acting force includes 20 N to 50 N; further, the value range of the first acting force includes 37 N to 47 N. Preferably, the first acting force is about 42 N.

[0119] In some embodiments, the value range of the second acting force includes 30 N to 60 N; further, the value range of the second acting force includes 45 N to 55 N. Preferably, the second acting force is about 50 N.

[0120] Controlling the first acting force and the second acting force within the above ranges can cause reasonable deformations of the first limiting groove 222 and the second limiting groove 223, enable the connecting shaft 131 to smoothly switch from the first limiting groove 222 to the second limiting groove 223, and reduce the risk of fracture of the first connecting portion 221 and avoid generating debris.

[0121] In some embodiments, the first connecting portion 221 has at least one of the following material property 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 properties can all be used as the material of the first connecting portion 221. The material properties and dimensional design of the first connecting portion 221 complement each other, both can promote reasonable deformation in the deformation area and reduce the generation of debris.

[0122] Such as Figure 3 、 Figure 4 and Figure 10As shown, in some embodiments, the clip device 10 further includes a connecting pin 230, and the receiving tube 120 and the sheath tube 210 are releasably connected through the connecting pin 230. In some embodiments, the proximal end of the receiving tube 120 includes at least two first limiting holes 124, the distal end of the sheath tube 210 includes second limiting holes 211 respectively arranged corresponding to the first limiting holes 124, the connecting pin 230 includes a tube portion 231 and at least two arms 232 extending distally from the tube portion 231, a limiting hook is arranged at the distal end of each arm 232, and each limiting hook respectively passes through the first limiting hole 124 and the second limiting hole 211, so that the receiving tube 120 and the sheath tube 210 are releasably connected. In some embodiments, the sheath tube 210 includes a spring end 240, 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 inside the spring end 240, and the second limiting hole 211 is arranged on the side wall of the spring end 240. By providing the spring end 240, it is convenient to assemble each component.

[0123] 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, when the mandrel 220 moves from the distal end to the proximal end, 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 a flank 410 at the distal end of the mandrel 220. In some other embodiments, a protrusion is provided at the distal end of the mandrel 220, and the protrusion constitutes the actuating portion 227. In some other embodiments, the actuating portion 227 is constituted by a connecting hook 226 at the distal end of the mandrel 220.

[0124] Figures 12A to 15 is a schematic diagram of the operation process of the clip device 10 shown in some embodiments of the present specification.

[0125] As Figure 12A and Figure 12B shown, after the clip device 100 performs operations such as opening, clamping, and closing, the mandrel 220 moves from the distal end to the proximal end until the mating portion 150 of the clip device 100 abuts against the limiting portion 121 of the receiving tube 120, restricting the clip 110 from continuing to move proximally. At this time, the first connecting portion 221 is in an undeformed state, the second connecting portion 130 cooperates with the first limiting groove 222; the blocking portion 400 acts radially on the blocked portion 140, and the radial gap between the proximal end of the clip 110 and the receiving tube 120 is maintained within a preset range.

[0126] As Figure 13A and Figure 13BAs shown, the mandrel 220 continues to move from the distal end towards the proximal end, generating a first acting force between the first connecting portion 221 and the second connecting portion 130. This first acting force causes the first limiting groove 222 to deform, and the second connecting portion 130 disengages from the first limiting groove 222 and mates with the second limiting groove 223. When the second connecting portion 130 switches 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. As a result, the blocking portion 400 and the blocked portion 140 are released from restraint, such as the proximal end of the clip 110 disengaging from the flank 410. Subsequently, the proximal end of the clip 110 deforms or displaces radially outward and approaches the side wall of the receiving tube 120, causing the locking portion 125 and the locked portion 115 to form a limiting fit, and the clip device 100 enters the locked state.

[0127] As Figure 14 shown, the mandrel 220 continues to move from the distal end towards the proximal end, generating a second acting force between the first connecting portion 221 and the second connecting portion 130. This second acting force causes the second limiting groove 223 to deform, and the second connecting portion 130 disengages from the second limiting groove 223. At this time, the first connecting portion 221 and the second connecting portion 130 are disengaged, and the mandrel 220 and the clip 110 are released.

[0128] As Figure 15 shown, the mandrel 220 continues to move from the distal end towards the proximal end. The actuating portion 227 at the distal end of the mandrel 220 drives the connecting pin 230 to move from the distal end towards the proximal end. The arm 232 of the connecting pin 230 is deformed or displaced under force and disengages from the first limiting hole 124 of the receiving tube 120 and the second limiting hole 211 of the sheath tube 210. At this time, the sheath tube 210 and the receiving tube 120 are released.

[0129] Subsequent embodiments will be introduced below based on the above-mentioned Embodiment 1. Structures or features that are the same or substantially the same as those in Embodiment 1 in the subsequent embodiments will not be described again, and only the differences from Embodiment 1 will be described in detail.

[0130] In the following, this specification will introduce in detail another technical solution of the clip instrument 10 through Embodiment 2. Compared with Embodiment 1, the main differences in Embodiment 2 lie in the blocking portion 400, the first connecting portion 221, and their related structures.

[0131] Figure 16 is an exemplary structural diagram of the distal end of the clip instrument 10 shown in some embodiments of this specification. Figure 17 is an exemplary structural diagram of the receiving tube 120 shown in some embodiments of this specification. Figure 18 is an exemplary structural diagram of the distal end structure of the mandrel 220 shown in some embodiments of this specification. Figure 19It is an exemplary structural diagram of the clip 110 shown according to some embodiments of this specification.

[0132] As Figures 16 to 19 shown, in some embodiments, the blocking portion 400 is disposed within the receiving tube 120 and protrudes radially inward. The blocking portion 400 is configured to come into contact with the blocked portion 140 to form a sliding constraint after at least two clips 110 are closed. Among them, the sliding constraint refers to a constraint method in which an object can only displace in a specific direction (such as the 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 blocked portion 140, the blocking portion 400 slides relative to the blocked portion 140, and the proximal end of the clip 110 moves closer radially, and the gap with the side wall of the receiving tube 120 is maintained within a preset range. By setting the blocking portion 400 and the blocked portion 140 as a sliding constraint, the clip 110 is constrained within a specific stroke range, which is beneficial to controlling the locking process of the clip 110 through the movement stroke of the clip 110, rather than relying on the magnitude of the acting force of the mandrel 220, making the operation simpler and more intuitive and reducing the risk of misoperation.

[0133] In some embodiments, the clip 110 includes a release hole 116. The release hole 116 is located at the distal end of the blocked portion 140. When the blocking portion 400 slides from the blocked portion 140 to the release hole 116, the blocking portion 400 is disengaged from the blocked portion 140. At this time, the proximal end of the clip 110 deforms or displaces radially outward and forms a lock with the side wall of the receiving tube 120.

[0134] 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 receiving tube 120, and the proximal ends protrude from the inner wall of the receiving tube 120. After the clip 110 is closed, the tube arms 420 are in sliding contact with the blocked portion 140 of the clip 110. When the tube arms 420 slide into the release hole 116, the contact relationship between the tube arms 420 and the blocked 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 in limit fit with the locking portion 125 on the side wall of the receiving tube 120. Here, the tube arms 420 and the release hole 116 also form a limit fit, thereby enhancing the locking stability.

[0135] In some embodiments, there are four tube arms 420. Two tube arms 420 are respectively arranged at the corresponding positions of each clip 110. A channel for the connecting shaft 131 to pass through is formed between the two tube arms 420 to prevent 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 tube arms 420. For example, two release holes 116 are provided 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.

[0136] In some embodiments, the first connecting portion 221 may include only one limiting groove 2211 adapted to the connecting shaft 131. After the clip device 100 is locked, the mandrel 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 mandrel 220 and the clip 110 are released.

[0137] In some embodiments, a radially increasing actuating portion 227 is provided at the distal end of the mandrel 220 for actuating the connecting pin 230 to move proximally, so that the receiving tube 120 and the sheath tube 210 are released.

[0138] Figures 20 to 23B It is a schematic diagram of the operation process of the clip instrument 10 shown in some embodiments of this specification.

[0139] As Figure 20 shown, the clip device 100 is in an open state. The first connecting portion 221 and the second connecting portion 130 are connected, and the blocking portion 400 and the blocked portion 140 have not yet come into contact.

[0140] As Figure 21 shown, the clip device 100 is in a closed state. The mandrel 220 moves from the distal end to the proximal end, driving the clip 110 to close. The proximal end of the clip 110 moves to abut against the blocking portion 400, and the blocking portion 400 acts radially on the blocked portion 140, so that a gap is maintained between the proximal end of the clip 110 and the side wall of the receiving tube 120. During the process of the mandrel 220 moving proximally, the blocking portion 400 forms a sliding constraint on the blocked portion 140.

[0141] As Figure 22 shown, the clip device 100 is in a locked state. The mandrel 220 moves from the distal end to the proximal end, causing the blocking portion 400 to slide from the blocked portion 140 into the release hole 116. The blocking portion 400 is disengaged from the blocked portion 140. At this time, the proximal end of the clip 110 deforms or displaces radially outward, so that the locked portion 115 cooperates with the locking portion 125 to form a lock on the side wall of the receiving tube 120. At the same time, the blocking portion 400 and the release hole 116 also form a locked state.

[0142] As Figure 23A and Figure 23B shown, the clip device 100 is in a released state. The mandrel 220 moves from the distal end to the proximal end, causing the first connecting portion 221 to separate from the second connecting portion 130. At the same time, the actuating portion 227 at the distal end of the mandrel 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.

[0143] In the following, this specification will introduce in detail another technical solution of the clip device 10 through Embodiment III. Compared with Embodiment I, the main differences in Embodiment III lie in the locked part 115 and the locking part 125 and their related structures.

[0144] Figure 24 is an exemplary structural diagram of the receiving tube 120 shown in some embodiments of this specification. Figure 25 is an exemplary structural diagram of the clip 110 shown in some embodiments of this specification.

[0145] In some embodiments, the locking part 125 and the locked part 115 form a limit fit inside the receiving tube 120 to prevent the locked part 115 from protruding from the side wall of the receiving tube 120, making the structure more compact.

[0146] In some embodiments, the locking part 125 includes a second convex part provided on the side wall of the receiving tube 120 and protruding radially inward, and the locked part 115 includes a second concave part provided on the clip 110. The second concave part cooperates with the second convex part to lock the clip device 100. In some embodiments, the second convex part can be similar in structure to the above-mentioned tube arm 420. At least two tube arms 420 are respectively 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 concave part can be similar in structure to the above-mentioned release hole 116. Since the blocking part 140 of the clip 110 cooperates with the flank 410 at the distal end of the mandrel 220, the function of the tube arm 420 only serves as the locking part 125. In some embodiments, the second concave part is a locking hole provided at the proximal end of the clip 110, and this locking hole is located at the distal end of the blocking part 140. When the blocking part 140 of the clip 110 is disengaged from the flank 410, the proximal end of the clip 110 deforms or displaces radially outward, so that the tube arm 420 cooperates with the locking hole, thereby locking the clip device 100.

[0147] Figures 26 to 28C is a schematic diagram of the operation process of the clip device 10 shown in some embodiments of this specification.

[0148] As Figure 26 shown, the clip device 100 is in a closed state. The mandrel 220 moves from the distal end to the proximal end, driving the clip 110 to close. The flank 410 acts on the blocking part 140 radially, so that there is always a gap between the proximal end of the clip 110 and the side wall of the receiving tube 120. During the process of the mandrel 220 moving towards the proximal end, the locking part 125 is in a suspended state.

[0149] As Figure 27As shown, the clip device 100 is in the locked state. The mandrel 220 continues to move from the distal end to the proximal end, generating a first acting force between the first connecting portion 221 and the second connecting portion 130. This first acting force causes the first limiting groove 222 to deform, and the second connecting portion 130 disengages from the first limiting groove 222 and fits into the second limiting groove 223. When the second connecting portion 130 switches 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, thus triggering the release of the constraint between the flank 410 and the blocked portion 140. Then, the proximal end of the clip 110 deforms or displaces radially outward and approaches the side wall of the receiving tube 120, such that the locking portion 125 and the locked portion 115 form a limiting fit, and the clip device 100 enters the locked state.

[0150] As Figures 28A to 28C shown, the clip device 100 is in the released state. The mandrel 220 moves from the distal end to the proximal end, separating the first connecting portion 221 from the second connecting portion 130. At the same time, the actuating portion 227 at the distal end of the mandrel 220 actuates the connecting pin 230 to disengage from the first limiting hole 124 and the second limiting hole 211, separating the sheath tube 210 from the receiving tube 120. At this time, the locking portion 125 and the locked portion 115 maintain the mating state, and the clip device 100 remains in the locked state.

[0151] In the following, this specification will introduce another technical solution of the clip instrument 10 in detail through Embodiment IV. Compared with Embodiment I, the main difference in Embodiment IV lies in the first connecting portion 221 and its related structures.

[0152] Figure 29A is an exemplary axonometric view of the distal end structure of the mandrel 220 shown in some embodiments of this specification. Figure 29B is according to Figure 29A shown, an exemplary front view of the distal end structure of the mandrel 220. Figure 29C is according to Figure 29A shown, an exemplary side view of the distal end structure of the mandrel 220.

[0153] As Figures 29A to 29C shown, in some embodiments, both the first limiting groove 222 and the second limiting groove 223 of the first connecting portion 221 are provided on the central axis of the mandrel 220, such that the mutual acting force between it and the second connecting portion 130 is along the central axis of the mandrel 220, which is more labor-saving and has higher stability.

[0154] In some embodiments, a guiding channel 224 is formed between the first limiting groove 222 and the second limiting groove 223. The guiding channel 224 is configured to guide the second connecting portion 130 into the second limiting groove 223 after the first limiting groove 222 is deformed. A release opening 225 is formed at the distal end of the second limiting groove 223. The release opening 225 is configured to release the second connecting portion 130 after the second limiting groove 223 is deformed. In this way, the movement of the connecting shaft 131 sequentially follows the first limiting groove 222, the guiding channel 224, and the second limiting groove 223, and then disengages from the release opening 225. The entire movement path is along the central axis of the mandrel 220, reducing structural vibration and improving stability.

[0155] In some embodiments, the first connecting portion 221 has the ability of elastic deformation, so that it can return to its original shape after the first limiting groove 222 is deformed, ensuring the connection stability between the second connecting portion 130 and the second limiting groove 223.

[0156] In some embodiments, the width of the guiding channel 224 is smaller than the diameter of the connecting shaft 131; the width of the release opening 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 range of the aperture diameter of the first limiting groove 222 and / or the second limiting groove 223 includes 0.5 mm to 0.6 mm; the width range of the guiding channel 224 includes 0.2 mm to 0.3 mm. Wherein, the width of the guiding channel 224 refers to the dimension in the direction perpendicular to the axis of the mandrel 220. The first connecting portion 221 is configured to have the above dimensions, so that it only deforms but does not break under force, reducing the generation of debris and improving the surgical safety.

[0157] Figures 30A to 30C It is a schematic diagram of the relative movement process of the first connecting portion 221 and the second connecting portion 130 shown in some embodiments of this specification.

[0158] As Figure 30A shown, the clip device 100 is in an unlocked state. The second connecting portion 130 cooperates with the first limiting groove 222, and the first connecting portion 221 is in an undeformed state.

[0159] As Figure 30B shown, the mandrel 220 moves from the distal end to the proximal end, causing the second connecting portion 130 to leave the first limiting groove 222 and enter the guiding channel 224, and the second connecting portion 130 causes the first connecting portion 221 to undergo the first elastic deformation.

[0160] As Figure 30CAs shown, the mandrel 220 continues to move from the distal end to the proximal end, causing the second connecting portion 130 to enter the second limiting groove 223. At this time, the first connecting portion 221 returns to its original shape, enabling the second limiting groove 223 to cooperate with the second connecting portion 130. Then, the mandrel 220 continues to move from the distal end to the proximal end, causing the release port 225 to deform due to the second connecting portion 130, and the second connecting portion 130 disengages from the second limiting groove 223, releasing the mandrel 220 and the clip 110.

[0161] In the following, another technical solution of the clip device 10 will be introduced in detail through Embodiment Five in this specification. Compared with Embodiment One, the differences in Embodiment Five mainly lie in the first connecting portion 221, the second connecting portion 130, the blocking portion 400, and their related structures.

[0162] Figure 31A is an exemplary structural diagram of the first predetermined form of the first connecting portion 221 shown in some embodiments of this specification. Figure 31B is an exemplary structural diagram of the second predetermined form of the first connecting portion 221 shown in some embodiments of this specification. Figure 32 is an exemplary structural diagram of the clip 110 shown in some embodiments of this specification.

[0163] As Figures 31A to 32 shown, in some embodiments, the first connecting portion 221 includes two connecting hooks 226, and the second connecting portion 130 is a connecting hole 132 provided at the proximal end of each clip 110. In some embodiments, the connecting hook 226 includes an arm portion 2261 and a hook portion 2262. The proximal end of the arm portion 2261 is connected to the mandrel 220, and the distal end is connected to the hook portion 2262. In some embodiments, the hook portion 2262 includes a first limiting region 2263 and a second limiting region 2264. One end of the first limiting region 2263 is connected to the arm portion 2261, and the other end is connected to the second limiting region 2264. In some embodiments, a first barb 2265 is provided at the connection between the first limiting region 2263 and the second limiting region 2264, and a second barb 2266 is provided at the distal end of the second limiting region 2264.

[0164] In the unlocked state, the two connecting hooks 226 cooperate with the connecting holes 132 of the two clamping pieces 110 respectively. For example, the connecting hook 226 cooperates with the connecting hole 132 in a first predetermined form, so that the first connecting portion 221 and the second connecting portion 130 are connected; wherein, the first predetermined form refers to the form in which the connecting hook 226 is not deformed. At this 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 may be that the arm portions 2261 of the two connecting hooks 226 approach each other, so that a preset gap can be maintained between the proximal end of the clamping piece 110 and the inner wall of the receiving 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 remains 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 state.

[0165] In the locked state, when the mandrel 220 moves from the distal end to the proximal end, the connecting hook 226 undergoes a first deformation or displacement due to the first acting force. The connecting hook 226 deforms 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 clamping piece 110 to deform or displace radially outward to cooperate with the receiving tube 120, and the clip device 100 enters the locked state. Among them, the second predetermined form refers to the form in which the arm portion 2261 and / or the first limiting area 2263 are deformed. At this time, the angle between the arm portion 2261 and the axis of the mandrel 220 increases, and the arm portions 2261 of the two connecting hooks 226 move away from each other, so that the proximal end of the clamping piece 110 can deform or displace radially outward to be locked and cooperate with the receiving 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 remains connected to the connecting hole 132. For example, the angle between the hook portion 2262 and the arm portion 2261 is a right angle or an obtuse angle. When the connecting hook 226 is in the second predetermined form, the connecting hole 132 passes over the first barb 2265 and cooperates with the second limiting area 2264, and the second barb 2266 forms a limit with the connecting hole 132.

[0166] In the released state, when the mandrel 220 continues to move from the distal end to the proximal end, the connecting hook 226 undergoes a second deformation or displacement due to the second acting force. The connecting hook 226 deforms from the second predetermined form to the third predetermined form, and is disengaged from the connecting hole 132 in the second predetermined form, and the first connecting portion 221 and the second connecting portion 130 are released. Among them, the third predetermined form refers to the form in which at least one of the arm portion 2261, the first limiting area 2263, and the second limiting area 2264 is deformed. At this time, the angle between the hook portion 2262 and the arm portion 2261 increases, so that the connecting hook 226 can be disengaged 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 disengaged from the second limiting area 2264.

[0167] In some embodiments, two connecting hooks 226 form a blocking portion 400. The proximal ends of at least two clamping pieces 110 are located between the two connecting hooks 226, and the two connecting hooks 226 act radially inwards on the proximal ends of the clamping pieces 110. When the connecting hooks 226 are in the first predetermined configuration, the connecting hooks 226 act radially inwards on the blocked portion 140 of the clamping piece 110, so that a gap within a predetermined range is maintained between the proximal end of the clamping piece 110 and the receiving tube 120. When the connecting hooks 226 are in the second predetermined configuration, the connecting hooks 226 release the radial limit on the blocked portion 140, and the proximal end of the clamping piece 110 deforms or displaces radially outwards, so that the locking portion 125 and the locked portion 115 cooperate, and the clip device 100 is locked.

[0168] Figures 33 to 35 It is a schematic diagram of the operation process of the clip instrument 10 shown in some embodiments of this specification.

[0169] As Figure 33 shown, the clip device 100 is in an unlocked state. The connecting hooks 226 are in the first predetermined configuration. The connecting hooks 226 are connected to the connecting holes 132 of the clamping pieces 110, and the connecting hooks 226 act radially inwards on the blocked portion 140, so that a gap within a preset range is maintained between the proximal end of the clamping piece 110 and the inner wall of the receiving tube 120, so as to allow the mandrel 220 to control the repeated opening or closing of the clamping piece 110.

[0170] As Figure 34 shown, the clip is in a locked state. The mandrel 220 moves from the distal end to the proximal end, driving the connecting hooks 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 restricts the further movement of the clamping piece 110 towards the proximal end. Continuing to pull the mandrel 220, a first acting force is generated between the connecting hooks 226 and the connecting holes 132. This first acting force causes the arm portions 2261 and / or the first limiting region 2263 of the connecting hooks 226 to deform. The connecting hooks 226 have the second predetermined configuration. The connecting hooks 226 release the cooperation with the blocked portion 140, and the proximal end of the clamping piece 110 deforms or displaces radially outwards, so that the locking portion 125 and the locked portion 115 cooperate, and the clamping piece 110 is locked with the receiving tube 120.

[0171] As Figure 35 shown, the clip device 100 is in a released state. The mandrel 220 moves from the distal end to the proximal end, and a second acting force is generated between the connecting hooks 226 and the connecting holes 132. This second acting force causes at least one of the arm portions 2261, the first limiting region 2263, and the second limiting region 2264 of the connecting hooks 226 to deform. The connecting hooks 226 have the third predetermined configuration. The connecting hooks 226 release the cooperation with the connecting holes 132, and the mandrel 220 is released from the clamping piece 110. In the third predetermined configuration, the connecting hooks 226 also act as an actuating portion 227 to actuate the connecting pin 230 to move towards the proximal end, so that the receiving tube 120 and the sheath tube 210 are released.

[0172] In the following, this specification will introduce another technical solution of the clip instrument 10 in detail through Example Six. Compared with Example One, the main difference in Example Six lies in the receiving tube 120 and its related structures.

[0173] Figure 36 It is an exemplary structural diagram of the distal end structure of the clip instrument 10 shown in some embodiments of this specification. Figure 37 It is an exemplary structural diagram of the receiving tube 120 shown in some embodiments of this specification.

[0174] As Figure 36 and Figure 37 shown, in some embodiments, the receiving tube 120 includes two slots 126 respectively arranged corresponding to the clip pieces 110. The slots 126 are provided at the distal end of the receiving tube 120, and the slots 126 are configured to provide an additional movement range for the clip pieces 110. By providing the slots 126, the movement angle of the clip pieces 110 is increased, so that the clip pieces 110 have a larger span in the open state, which is beneficial for clamping larger wounds or tissues.

[0175] In some embodiments, the distal end of the receiving tube 120 includes a limiting structure 127. The limiting structure 127 is used to limit the clip pieces 110 from disengaging from the receiving tube 120 at the distal end, which may limit the movement range of the clip pieces 110. By providing the slots 126, the influence of the limiting structure 127 on the clip pieces 110 is reduced, and the span of the clip pieces 110 reaches the expected effect, meeting the surgical requirements.

[0176] In the following, this specification will introduce another technical solution of the clip instrument 10 in detail through Example Seven. Compared with Example One, the main difference in Example Seven lies in the receiving tube 120 and its related structures.

[0177] Figure 38 It is an exemplary structural diagram of the receiving tube 120 shown in some embodiments of this specification. Figure 39 It is an exemplary cross-sectional view of the distal end structure of the clip instrument 10 shown in some embodiments of this specification.

[0178] In some embodiments, the receiving tube 120 includes a limiting structure 127 provided at its distal end. The limiting structure 127 is configured to limit the clip pieces 110 from moving distally when the clip pieces 110 are opened, so as to prevent the clip pieces 110 from disengaging or protruding excessively distally from the receiving tube 120.

[0179] 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.

[0180] 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.

[0181] Figure 40 is a flow chart of a method of operating the clip instrument 10 according to some embodiments of the present specification.

[0182] 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:

[0183] 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.

[0184] In some embodiments, the clip instrument 10 includes a blocking portion 400 , and the clip 110 includes a blocked portion 140 .

[0185] 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.

[0186] In some embodiments, the blocking portion 400 is disposed within the receiving tube 120 and protrudes radially inwardly. A release hole 116 is provided 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. In this way, 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.

[0187] In some embodiments, the first connecting portion 221 includes a first limiting groove 222 and a second limiting groove 223. The above first matching state may be a state in which the first limiting groove 222 is pre-matched with the second connecting portion 130. In some embodiments, the first connecting portion 221 includes a connecting hook 226. The first matching state may be a state in which the connecting hook 226 is matched with the second connecting portion 130 when it is not deformed.

[0188] Step 820, the mandrel 220 is moved from the distal end to the proximal end, so that the first connecting portion 221 and the second connecting portion 130 are switched to the second matching state, thereby triggering the release of the constraint between the blocking portion 400 and the blocked portion 140, so that the proximal end of the clip 110 deforms or displaces radially outward to cooperate with the receiving tube 120, and the clip device 100 is locked.

[0189] 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 connecting portion 221 and the second connecting portion 130 is equal to the first acting force, the first limiting groove 222 is deformed or displaced due to the first acting force and is disengaged from the second connecting portion 130, so that the second limiting groove 223 and the second connecting portion 130 are connected, and the first connecting portion 221 and the second connecting portion 130 are switched to the second matching state. During this process, the first connecting portion 221 and the second connecting portion 130 have an axial relative displacement, triggering the release of the constraint between the blocking portion 400 and the blocked portion 140. For example, the blocked portion 140 disengages from the flank 410 at the distal end of the mandrel 220, or the tube arm 420 of the receiving tube 120 cooperates with the release hole 116, etc.

[0190] In some embodiments, the operating device 300 operates the mandrel 220 to move from the distal end to the proximal end, and a first acting force is generated between the connecting hook 226 and the connecting hole 132. This first acting force causes the first limiting region 2263 of the connecting hook 226 to deform, and the second limiting region 2264 of the connecting hook 226 cooperates with the connecting hole 132. Since the first limiting region 2263 of the connecting hook 226 is deformed, the connecting hook 226 is disengaged from the blocked portion 140.

[0191] In some embodiments, the receiving tube 120 includes a locking portion 125, and the clip 110 includes a locked portion 115. The operating device 300 operates to release the restraint between the blocking portion 400 and the blocked portion 140, and the proximal end of the clip 110 deforms or displaces radially outward, so that the locking portion 125 cooperates with the locked portion 115. In some embodiments, the locking portion 125 includes a first recess provided on the side wall of the receiving tube 120, and the locked portion 115 includes a first protrusion provided on the proximal end of the clip 110, and the first recess and the first protrusion form a limit fit on the side wall of the receiving tube 120. In some embodiments, the locking portion 125 includes a second protrusion provided on the side wall of the receiving tube 120, and the locked portion 115 includes a second recess provided on the proximal end of the clip 110, and the second protrusion and the second recess form a limit fit inside the receiving tube 120.

[0192] 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.

[0193] In some embodiments, the clip instrument 10 further includes a connecting pin 230. The receiving tube 120 and the sheath tube 210 are releasably connected through the connecting pin 230. The distal end of the mandrel 220 includes an actuating portion 227. After the clip device 100 is locked, the operating device 300 operates the mandrel 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.

[0194] The beneficial effects that may be brought by the embodiments of the present application include but are not limited to:

[0195] (1) When the blocking portion cooperates with the blocked portion, the two clips can be freely opened or closed. When the blocking portion is disengaged from the blocked portion, the proximal ends of the two clips can deform or displace radially outward and be locked with the receiving tube. The entire locking process is caused by the automatic deformation of the proximal ends of the clips, reducing the locking operation.

[0196] (2) After the proximal end of the clip cooperates with the receiving tube, the receiving tube can limit the axial displacement and radial displacement of the proximal end of the clip, improving the locking stability of the clip.

[0197] (3) Before and when the clip is locked, the first connecting portion and the second connecting portion are connected. After the clip is locked, the first connecting portion is released from the second connecting portion, making the operation more accurate and reliable, reducing the possibility of misoperation, and improving the safety of the surgical operation.

[0198] (4) The blocking portion and the blocked portion are released from the restraint by axially displacing relative to each other. In this way, the release timing of the blocking portion and the blocked portion can be accurately controlled by the axial movement of the mandrel. The operation is simple and fast, ensuring that the clip device is accurately released when needed, and improving the accuracy of the surgical operation.

[0199] (5) The pre-tightening part on the flank is configured to provide a pre-tightening force to the proximal end of the clip, which presses the proximal end of the clip against the first connecting part. When the clip moves axially in the unlocked state, it can prevent the proximal end of the clip from accidentally slipping out of the gap between the flank and the first connecting part, avoiding accidental situations such as premature self-locking or locking failure of the clip.

[0200] (6) Optimize the structure and size of the first connecting part, especially the size design of the first deformation area and the second deformation area, so that the first acting force and the second acting force can cause these areas to deform within a reasonable range, which is beneficial to controlling the movement state of the connecting shaft. At the same time, the first deformation area and the second deformation area undergo a more reasonable deformation when subjected to a predetermined acting force, avoiding structural fracture caused by excessive deformation, reducing the generation of debris, and improving the surgical safety.

[0201] (7) By setting the blocking part and the blocked part as a sliding constraint, the clip is constrained within a specific stroke range, which is beneficial to controlling the locking process of the clip through the movement stroke of the clip, rather than relying on the magnitude of the acting force of the mandrel, making the operation simpler and more intuitive, and reducing the risk of misoperation.

[0202] (8) The locking part and the locked part form a limiting fit inside the receiving tube to prevent the locked part from protruding from the side wall of the receiving tube, making the structure more compact.

[0203] (9) Both the first limiting groove and the second limiting groove are provided on the central axis of the mandrel, and the entire movement path of the connecting shaft is along the central axis of the mandrel, reducing structural vibration and improving stability.

[0204] (10) By setting the slot, the movement angle of the clip increases, so that the clip has a larger span in the open state, which is beneficial to clamping a larger wound or tissue.

[0205] (11) The limiting structure is arranged at an angle relative to the axis of the receiving tube. When the receiving tube and the clip are in the locked state and the distance from the proximal end of the receiving tube to the distal end of the clip remains unchanged, the clip has a larger movement amplitude at the position of the limiting structure, thereby increasing the span of the clip.

[0206] It should be noted that the beneficial effects that may be produced by different embodiments are different. In different embodiments, the beneficial effects that may be produced can be a combination of any one or several of the above, or any other beneficial effects that may be obtained.

[0207] The basic concepts have been described above. Obviously, for those skilled in the art, the above detailed disclosure is only an 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 fall within the spirit and scope of the exemplary embodiments of this specification.

[0208] It should be noted that, in order to simplify the presentation of the disclosure of this specification and thus help the understanding of one or more embodiments, in the foregoing description of the embodiments of this specification, sometimes multiple features are grouped into one embodiment, drawing, or description thereof. However, this disclosure method does not mean that the features required for the object of this specification are more than those mentioned in the claims. In fact, the features of the embodiments are fewer than all the features of the individual embodiments disclosed above.

[0209] In some embodiments, numbers are used to describe components and the quantity of attributes. It should be understood that such numbers used for the description of embodiments are, in some examples, modified by the modifiers "about", "approximately", or "substantially". Unless otherwise stated, "about", "approximately", or "substantially" indicate that the said numbers allow a variation of ±20%. Accordingly, in some embodiments, the numerical parameters used in the specification and claims are approximate values, and such approximate values may change according to the characteristics required by individual embodiments. In some embodiments, the numerical parameters should consider the specified significant digits and adopt the method of retaining the general number of digits. Although the numerical ranges and parameters used in some embodiments of this specification to confirm the breadth of their scope are approximate values, in specific embodiments, such numerical settings are as precise as possible within the feasible range.

[0210] 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, by way of example and not limitation, alternative configurations of the embodiments of this specification can be considered to be in accordance 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 clip device, characterized in that, Comprising: A conveying device, including a sheath tube and a mandrel disposed within the sheath tube, wherein the distal end of the mandrel includes a first connection portion; A clip device, including at least two clip pieces, a receiving tube, and a second connection portion, wherein the receiving tube is disposed at the distal end of the sheath tube, the proximal ends of the clip pieces are axially movably disposed within the receiving tube, the clip pieces include a blocked portion, and the clip pieces and the mandrel are releasably connected through the first connection portion and the second connection portion; A blocking portion configured to control the state of the proximal ends of the clip pieces by acting radially on the blocked portion; Wherein, the clip device includes an unlocked state, a locked state, and a released state: In the unlocked state, the blocking portion is configured to radially inwardly constrain the blocked portion such that the radial gap between the proximal ends of the clip pieces and the receiving tube is within a preset range, and the first connection portion is connected to the second connection portion; In the locked state, the blocking portion is disengaged from the blocked portion such that the proximal ends of the clip pieces are radially outwardly deformed or displaced to cooperate with the receiving tube, and the first connection portion is connected to the second connection portion; In the released state, the first connection portion is disconnected from the second connection portion.

2. The clip device according to claim 1, wherein The blocking portion is disposed at the distal end of the mandrel, and the blocking portion and the blocked portion are disengaged by an axial relative displacement; The receiving tube includes a limiting portion, the clip device includes a cooperating portion, when the clip pieces move from the distal end to the proximal end and the cooperating portion abuts against the limiting portion, the limiting portion restricts the clip pieces from moving from the distal end to the proximal end, and when the mandrel continues to move proximally, an axial relative displacement occurs between the blocking portion and the blocked portion.

3. The clip device according to claim 1 or 2, characterized in that, The blocking portion includes two side wings, the two side wings are respectively located on both sides of the first connection portion and are used to press the proximal ends of the clip pieces against the first connection portion; The side wing includes a body and a pre-tightening portion, the proximal end of the body is fixed to the distal end of the mandrel, the distal end of the body is connected to the pre-tightening portion, the pre-tightening portion is configured to provide a pre-tightening force to the proximal ends of the clip pieces, and the pre-tightening force causes a first preset angle to be formed between the proximal ends of the clip pieces and the first connection portion.

4. The clip device according to claim 1, wherein, The blocking portion is disposed within the receiving tube and protrudes radially inwardly, and the blocking portion is configured to contact the blocked portion to form a sliding constraint after the at least two clip pieces are closed; The clip piece includes a release hole located at the distal end of the blocked portion, and when the blocking portion slides from the blocked portion to the release hole, the blocking portion is disengaged from the blocked portion.

5. The clip device according to claim 4, wherein, The blocking portion includes at least two tube arms, the at least two tube arms are respectively arranged corresponding to the at least two clip pieces, the distal ends of the tube arms are connected to the receiving tube, and the proximal ends protrude from the inner wall of the receiving tube.

6. The clip device according to claim 1, characterized in that, The receiving tube includes a locking portion, the clip piece includes a locked portion, after the blocking portion is disengaged from the blocked portion, the proximal ends of the clip pieces are radially outwardly deformed or displaced such that the locking portion cooperates with the locked portion.

7. The clip device according to claim 6, wherein, The locking portion and the locked portion form a limiting fit on the side wall of the receiving tube; The locking portion includes a first recess provided on the side wall of the receiving tube, and the locked portion includes a first protrusion provided at the proximal end of the clip piece and protruding radially outward. The first recess and the first protrusion cooperate to lock the clip device.

8. The clip device according to claim 6, wherein, The locking portion and the locked portion form a limiting fit inside the receiving tube; The locking portion includes a second protrusion provided on the side wall of the receiving tube and protruding radially inward, and the locked portion includes a second recess provided on the clip piece. The second recess and the second protrusion cooperate to lock the clip device.

9. The clip device according to claim 1, wherein, The first connecting portion includes a first limiting groove and a second limiting groove. In the unlocked state, the first limiting groove is connected to the second connecting portion; When the mandrel moves from the distal end to the proximal end, the first limiting groove is deformed or displaced due to a first acting force and is disengaged 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 undergo an axial relative displacement to release the constraint; When the mandrel continues to move from the distal end to the proximal end, the second limiting groove is deformed or displaced due to a second acting force and is disengaged 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, wherein, The receiving tube includes two slots respectively arranged corresponding to the clip pieces. The slots are provided at the distal end of the receiving tube, and the slots are configured to provide an additional movement range for the clip pieces; and / or, The receiving tube includes a limiting structure provided at its distal end. The limiting structure is configured to limit the distal movement of the clip piece when the clip piece is opened; the range of the fifth preset angle between the limiting structure and the axis of the receiving tube includes 40° to 90°.

11. The clip device according to claim 1, wherein, The clip instrument further includes a connecting pin. The receiving tube and the sheath tube are releasably connected through the connecting pin. The distal end of the mandrel includes an actuating portion. The connecting pin is configured to: after the clip device is locked, when the mandrel moves from the distal end to the proximal end, the actuating portion actuates the connecting pin to deform and / or displace, so that the receiving tube and the sheath tube are released.

12. The clip device according to claim 1, wherein, The first connecting portion is located between the proximal ends of the at least two clip pieces.

13. The clip device according to claim 1, wherein, The first connecting portion includes two connecting hooks, and the second connecting portion is a connecting hole provided at the proximal end of each clip piece; In the unlocked state, the two connecting hooks are respectively engaged with the connecting holes of the two clip pieces, and the first connecting portion and the second connecting portion are connected; In the locked state, the connecting hooks are deformed or displaced for the first time due to a first acting force, so that the connecting hooks remain engaged with the connecting holes, and the proximal ends of the clip pieces are deformed or displaced radially outward to cooperate with the receiving tube; In the released state, the connecting hooks are deformed or displaced for the second time due to a second acting force, so that the connecting hooks are disengaged from the connecting holes, and the first connecting portion and the second connecting portion are released.

14. The clip device according to claim 13, wherein, The two connecting hooks constitute the blocking portion. The proximal ends of the at least two clip pieces are located between the two connecting hooks, and the two connecting hooks act on the proximal ends of the clip pieces radially inward.

15. A clip device, characterized in that, Comprising: Delivery device, comprising a sheath tube and a mandrel disposed within the sheath tube, the distal end of the mandrel including a first connecting portion; Clip device, comprising at least two clip pieces, a receiving tube and a second connecting portion, the receiving tube being disposed at the distal end of the sheath tube, the clip pieces and the mandrel being releasably connected through the first connecting portion and the second connecting portion, the clip device including 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 mating state, and the proximal end of the clip piece is axially movably disposed within the receiving tube; In the locked state, the first connecting portion is deformed or displaced due to a first acting force, and forms a second mating state with the second connecting portion, and the proximal end of the clip piece is locked with the receiving tube; In the released state, the first connecting portion is deformed or displaced due to a second acting force, and is disengaged from the second connecting portion, and the mandrel is disengaged from the clip piece.

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

17. The clip device according to claim 16, wherein, The first limiting groove is located at the proximal end of the first connecting portion and is provided on the central axis of the mandrel, 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 mandrel.

18. The clip device according to claim 17, wherein The range of the third preset angle between the opening directions of the first limiting groove and the second limiting groove includes 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 mandrel includes 40° to 90°.

19. The clip device according to 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 range of the opening size of the first limiting groove includes 0.1 mm to 0.3 mm.

20. The clip device according to claim 17, wherein The first connecting portion includes a first deformation region, which is arranged corresponding to the first limiting groove and is configured to be deformed under the first acting force, and the range of the maximum size of the first deformation region includes 0.55 mm to 0.65 mm; The first connecting portion includes a second deformation region, which is arranged corresponding to the second limiting groove and is configured to be deformed under the second acting force, and the range of the maximum size of the second deformation region includes 0.35 mm to 0.45 mm.

21. The clip device according to claim 16, wherein, Both the first limiting groove and the second limiting groove are provided on the central axis of the mandrel.

22. The clip device according to claim 21, wherein, A guiding channel is formed between the first limiting groove and the second limiting groove, and the guiding channel is configured to guide the second connecting portion into 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 according to claim 22, wherein, The first limiting groove and / or the second limiting groove is a hole-shaped groove, and the aperture range of the first limiting groove and / or the second limiting groove includes 0.5 mm to 0.6 mm; the width range of the guiding channel includes 0.2 mm to 0.3 mm.

24. The clip device according to claim 15, wherein, The first connecting portion includes two connecting hooks, and the second connecting portion is a connecting hole provided at the proximal end of each clip; In the unlocked state, the connecting hooks are engaged with the connecting holes in a first predetermined configuration; When the mandrel moves from the distal end to the proximal end, the connecting hooks are deformed or displaced due to a first acting force and are engaged with the connecting holes in a second predetermined configuration, and the clip device enters the locked state; When the mandrel continues to move from the distal end to the proximal end, the connecting hooks are deformed or displaced due to a second acting force and are disengaged from the connecting holes in a third predetermined configuration, and the first connecting portion and the second connecting portion are released.

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

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

27. The clip device according to claim 15, wherein The clip instrument further includes a blocking portion, and the clip includes a blocked portion; In the unlocked state, the blocking portion radially inwardly restricts the blocked portion, 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 switched to the second mating state, the blocking portion and the blocked portion are directly or indirectly triggered to be released from the restraint, and the proximal end of the clip is deformed radially outward to cooperate with the receiving tube.

28. The clip device according to 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 the restraint, the proximal end of the clip is deformed radially outward so that the locking portion and the locked portion are engaged.

29. The clip instrument according to claim 15, wherein The clip instrument further includes a connecting pin. The receiving tube and the sheath tube are releasably connected through the connecting pin. The distal end of the mandrel includes an actuating portion. The connecting pin is configured to: after the clip device is locked, when the mandrel moves from the distal end to the proximal end, the actuating portion actuates the connecting pin to be deformed and / or displaced, so that the receiving tube and the sheath tube are released.

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