Hemostatic clip with suture line locking function and hemostatic system

Abstract

The invention provides a hemostatic clip with a suture line locking function and a hemostatic system, and relates to the technical field of medical instruments.The hemostatic clip comprises a clip base and a clip piece, the clip piece at least comprises a clamping part extending to the far end and a tail part extending into the clip base at the near end in the longitudinal extending direction, and the clamping part is arranged on the clip base. The clamping part is provided with a locking structure which allows a suture line to penetrate through and can lock the suture line. In the non-locking state, the suture line can penetrate through the locking structure and move relative to the clamping part; in the locking state, the locking structure provides friction force of 0.1 N to 15 N for the suture line; by means of the hemostatic clip, the hemostatic clips can be gathered one by one in the wound surface closing operation, the situation that the hemostatic clips collapse or lodging towards the interior of the wound surface is avoided, the operation mode is simpler, and the operation efficiency can be obviously improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a hemostatic clip with locking suture function and a hemostatic system. Background Technology

[0002] With the development of endoscopic technology, endoscopic hemostasis has become the preferred method for treating gastrointestinal bleeding. Currently, commonly used endoscopic hemostasis methods include laser coagulation, electrocoagulation, local injection of hemostatic agents, drug spraying, and hemostatic clip closure. Among these, hemostatic clip closure has become the most effective and clinically valuable non-surgical treatment for gastrointestinal bleeding due to its minimal invasiveness, rapid hemostasis, low rebleeding rate, few complications, and definite efficacy.

[0003] Existing hemostatic clips are typically inserted into the human digestive tract through an endoscope. Because the size of the endoscope channel is limited, the outer diameter of the clip cannot be designed to be too large, resulting in a small clip opening size. This makes them suitable for hemostasis of small wounds. When hemostasis of large wounds is required, multiple clips need to be used in combination, and the clips need to be secured with sutures after being brought together, making the operation quite complex. Increasing the size of the clips to increase the applicable wound size would make it difficult for patients to excrete the clamping part of the clip through the digestive tract.

[0004] As can be seen from the publicly available information in existing literature (“Suturing techniques with endoscopic clips and special devices after endoscopic resection”, Tatsuma Nomura et al., Digestive Endoscopy, 2022), (e.g.) Figure 1 As shown in the diagram, in current clinical procedures using hemostatic clips to suture large wounds, the suture passes through the intersection of the two proximal ends of each clip. After passing through all the clips, the surgeon tightens the suture to close the wound. During tightening, the clips slide relative to the suture, resulting in very weak control over each clip. Therefore, some clips may fall into the wound during tightening, requiring the surgeon to handle them, increasing the difficulty of the procedure. Furthermore, due to the often complex nature of surgical sites, failure to detect fallen clips in time significantly reduces surgical safety. Additionally, due to differences in position and orientation, the tightening force on each clip is difficult to achieve uniformity. Finally, to ensure complete wound closure, some clips may experience excessive tension and break off, further increasing the surgeon's difficulty and reducing surgical efficiency. Summary of the Invention

[0005] The purpose of this invention is to provide a hemostatic clip and hemostatic system with locking suture function to solve the problems existing in the prior art. During wound closure surgery, the hemostatic clips can be gathered one by one to avoid the hemostatic clips breaking off or falling into the wound. The operation method is simpler and can significantly improve surgical efficiency.

[0006] To achieve the above objectives, the present invention provides the following solution:

[0007] A hemostatic clip with suture locking function includes a clip base and a clip piece. The clip piece includes at least a clamping portion extending distally in the longitudinal direction and a tail portion extending proximally into the clip base. The clamping portion is provided with a locking structure for the suture to pass through and for locking the suture. In the unlocked state, the suture can pass through the locking structure and move relative to the clamping portion. In the locked state, the locking structure provides a frictional force of 0.1N to 15N to the suture.

[0008] As one embodiment, in the locked state, the locking structure provides a frictional force of 0.3N to 9N to the suture.

[0009] As one embodiment, the locking structure is a slit provided on the side wall of the clamping part and extending longitudinally.

[0010] As one embodiment, the clamping part is further provided with a threading structure, the maximum width of which is greater than the diameter of the suture. The threading structure is connected to the slit through a connecting structure, which allows the suture to move from the threading structure into the slit and be locked in place.

[0011] As one embodiment, the threading structure is disposed longitudinally on at least a portion of the slit.

[0012] As one embodiment, the threading structure is a through hole, and the through hole is at least partially arc-shaped in the circumferential direction.

[0013] As one embodiment, in the communication direction between the threading structure and the slit, an anti-loosening part is provided on the wall of the communication structure, the anti-loosening part being used to prevent the suture from moving from the slit into the threading structure.

[0014] As one embodiment, the anti-detachment part is a barb extending toward the slit; or, the anti-detachment part is an arc-shaped or semi-arc-shaped tapering structure with a minimum width smaller than the maximum width of the slit.

[0015] As one embodiment, the edge of the slit has a cutting edge for cutting the suture.

[0016] As one embodiment, along the longitudinal extension direction of the slit, the slit includes a thread-locking area and a cutting area, and the cutting edge of the cutting area is provided with the cutting blade.

[0017] As one implementation, the length of the cutting area is no greater than 1 / 2 of the slit length.

[0018] As one embodiment, the slit is further provided with an outward-facing protrusion, and the cutting blade is provided on the outward-facing protrusion.

[0019] The present invention also provides a hemostasis system, including a hemostatic clip with locking suture function as described above and a suture, wherein the suture is used to pass through the locking structure of the hemostatic clip; multiple hemostatic clips are provided, and the suture passes through the locking structure in sequence, and the hemostatic clips are locked in sequence under the combined force of the suture tension and friction.

[0020] As one embodiment, the suture is a radially compressible soft thread, and the suture is interference-fitted with the locking structure.

[0021] In one embodiment, the suture is a radially incompressible rigid thread, the suture is clearance-fitted with the locking structure, and the suture is bent after passing through the locking structure so that the surface of the suture fits against the slit.

[0022] The present invention has the following technical advantages over the prior art:

[0023] This invention provides a locking structure on the clips, which can provide a frictional force of 0.1N to 15N to the suture, enabling rapid and reliable locking between the suture and the clips. Thus, during surgery, when closing a large wound, the surgeon can quickly and reliably lock the hemostatic clips one by one and ensure that all the hemostatic clips are in a converged and locked state when the wound is closed. Compared to existing methods of closing wounds using hemostatic clips, this invention allows for more uniform wound contraction and more even tension on the hemostatic clips within the wound tissue. When locked, each clip is independently constrained by the sutures, effectively preventing it from collapsing into the wound and reducing the risk of dislodgement. This ensures a secure and stable hold on the wound tissue. Furthermore, this method eliminates the need for sutures to gather and secure all clips together, simplifying wound closure and preventing clips from collapsing during simultaneous gathering. This eliminates the need for surgeons to manage clip collapse or dislodgement, significantly improving surgical efficiency and safety.

[0024] It is evident that this invention, by improving the structure of the hemostatic clip, provides a superior and newer surgical technique that differs from existing methods of closing large-area wounds using hemostatic clips. This new technique effectively improves surgical efficiency and safety without increasing the difficulty of operation for the operator.

[0025] Other technical solutions in this invention also have the following technical effects:

[0026] The invention also includes a threading structure that communicates with the locking structure. The maximum width of the threading structure is greater than the diameter of the suture, which reduces the friction between the threading structure and the suture, making it easier to thread the suture and also facilitating the relative movement of the hemostatic clip and the suture when tightening the suture.

[0027] The present invention also provides a cutting blade on the edge of the slit to facilitate the cutting of excess sutures. Attached Figure Description

[0028] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0029] Figure 1 This diagram illustrates the use of hemostatic clips and sutures in wound closure in existing technologies.

[0030] Figure 2 This is a schematic diagram illustrating the use of a hemostatic clip with suture locking function and a hemostatic system in wound closure according to one embodiment of the present invention.

[0031] Figure 3 This is a schematic diagram of the hemostatic clip in one embodiment of the present invention;

[0032] Figure 4 This is a schematic diagram of a slit structure in one embodiment of the present invention;

[0033] Figure 5 This is a schematic diagram of a slit structure in another embodiment of the present invention;

[0034] Figure 6 This is a schematic diagram illustrating the cooperation between the slit and the threading structure in one embodiment of the present invention;

[0035] Figure 7 This is a schematic diagram illustrating the cooperation between the slit and the threading structure in another embodiment of the present invention;

[0036] Figure 8 This is a schematic diagram illustrating the gap fit between the slit and the suture line in one embodiment of the present invention;

[0037] Figure 9 This is a schematic diagram illustrating the interference fit between the slit and the suture in one embodiment of the present invention;

[0038] Figure 10a This is a schematic diagram of a structure in one embodiment of the present invention where the anti-detachment part is a barb;

[0039] Figure 10b This is a schematic diagram of a structure in one embodiment of the present invention where the anti-detachment part is a closed opening;

[0040] Figure 11 This is a schematic diagram of a structure with a cutting blade at the slit in one embodiment of the present invention;

[0041] Figure 12 This is a schematic diagram of a structure with a cutting edge at the slit in another embodiment of the present invention;

[0042] Figure 13 This is a schematic diagram of a structure with a cutting edge at the slit (the cutting edge is present on half the length of the slit edge) in another embodiment of the present invention;

[0043] Figure 14 This is a schematic diagram of a structure with an outwardly turned-out boss at the slit in another embodiment of the present invention;

[0044] Figure 15 This is a schematic diagram of the hemostasis system in one embodiment of the present invention;

[0045] Figure 16 This is a schematic diagram of a threading structure located in the middle of a slit in one embodiment of the present invention.

[0046] Explanation of reference numerals in the attached figures:

[0047] 1. Hemostatic clip; 2. Clip base; 3. Clip plate; 4. Clamping part; 5. Tail; 6. Slit; 7. Suture; 8. Threading structure; 9. Cutting blade; 10. Outward-facing protrusion; 11. Connecting structure; 12. Anti-dislodgement part; 13. Operating structure. Detailed Implementation

[0048] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0049] The purpose of this invention is to provide a hemostatic clip and hemostatic system with locking suture function to solve the problems existing in the prior art. During wound closure surgery, the hemostatic clips can be gathered one by one to avoid the hemostatic clips breaking off or falling into the wound. The operation method is simpler and can significantly improve surgical efficiency.

[0050] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0051] Example 1:

[0052] like Figures 2 to 15 As shown, this embodiment provides a hemostatic clip 1 with a locking suture 7 function, including a clip base 2 and clip pieces 3. The clip piece 3 includes at least a distally extending clamping portion 4 and a tail portion 5 extending into the proximal clip base 2 in the longitudinal extension direction. The clamping portion 4 is used to clamp wound tissue, and the tail portion 5 is used to rotatably mount the clip piece 3 in the clip base 2. Each clip base 2 typically provides two clip pieces 3, and the two clip pieces 3 cooperate with each other to clamp the wound tissue using the clamping portion 4. The connection structure between the clip piece 3 and the clip base 2 can use an existing structure. The clamping portion 4 is provided with a locking structure for the suture 7 to pass through and to lock the suture 7; wherein, in the unlocked state, the locking structure allows the suture 7 to pass through and move relative to the clamping portion 4; in the locked state, the locking structure provides a frictional force of 0.1N to 15N to the suture 7. Preferably, the locking structure provides a frictional force of not less than 0.3N to the suture 7, ensuring that even under relatively large tensile forces, the locking structure can still provide sufficient frictional force to lock the hemostatic clip. Specifically, through testing on different tissues, a frictional force of 0.1N to 15N is the minimum frictional force value to ensure that the locking structure on the clip meets the requirement of locking the suture 7.

[0053] The specific method for testing the frictional force of the locking structure on the suture 7 is as follows:

[0054] 1) Lay a biological tissue sample to be sutured, approximately 200mm x 200mm in size, flat on a horizontal test platform, and cut a circular wound with a diameter of approximately 20mm on its surface to serve as the test phantom;

[0055] 2) Prepare sutures of different materials, approximately 300 mm long and 0.1 mm to 0.55 mm in diameter, as test samples;

[0056] 3) Simulate intraoperative operation: take one end of the suture 7 and pass it through the locking structure at the distal end of the clip 3. Pull one end of the suture 7 so that the other end of the suture 7 remains in the position of the locking structure.

[0057] 4) Clamp the hemostatic clip 1 along one side of the wound on the phantom and then release the hemostatic clip 1;

[0058] 5) Fix the free end of the suture 7 (the end not locked by the hemostatic clip 1) to the digital push-pull force gauge. Pull the digital push-pull force gauge at a constant speed along the horizontal direction of the wound. Under the traction of the suture 7, the hemostatic clip 1 pulls the tissue on one side of the wound toward the tissue on the other side and abuts it (wound closed state). During this process, the hemostatic clip 1, under the traction of the suture 7, causes the tissue on one side of the wound to move a distance of not less than 20mm to the other side. Record the reading of the push-pull force gauge when the wound is completely closed, and record it as the test result of the locking friction force of the locking structure on the suture 7.

[0059] During the friction test experiment, the test samples at least included biological digestive samples (such as stomach tissue and intestinal tissue). The locking structure size, suture type 7, and suture size 7 were used as influencing factors for the friction test. An experimental verification scheme was designed, and the above experimental steps were used to record the locking friction force values ​​of the locking structure on the suture 7 under different influencing factors. Finally, it was found that under the friction force of 0.1N to 15N, the locking structure can effectively lock the suture 7 under different states and complete the effective closure of the wound.

[0060] Because the locking structure in this embodiment can provide a frictional force of 0.1N to 15N to the suture 7, it can maintain a locked state with the suture 7 without external force intervention, that is, keep the positions of the clip 3 and the suture 7 relatively fixed. In other words, when the suture 7 and the locking structure are moved to a designated position under the operation of the operator, and the operator removes the external force, the positions of the hemostatic clip 1 and the suture 7 can remain relatively fixed. When performing hemostasis on large wounds, a set of hemostatic clips 1 are arranged at intervals around the wound, and the suture 7 passes through the locking structure on the clip 3 in sequence. Each time the suture 7 passes through the locking structure of a clip 3, the surgeon pulls and tightens the suture 7. The locking structure on each clip 3 provides friction, locking the suture 7 relative to the clip 3. During this process, the hemostatic clip 1 moves to the designated position under the pull of the suture 7, bringing the two hemostatic clips 1 close together. As the hemostatic clip 1 moves, the wound is contracted. After tightening the suture 7, the relative position of the suture 7 and the hemostatic clip 1 is fixed because the locking structure provides sufficient friction. The same method is then used to pass the suture 7 through the locking structure of the next clip 3, and the suture 7 is tightened accordingly. This process is repeated, and a circle of hemostatic clips 1 gradually becomes tighter, the wound is gradually contracted, and finally the large wound is closed.

[0061] This embodiment provides a locking structure on the clip 3, which can provide a frictional force of 0.1N to 15N to the suture 7, thereby achieving a fast and reliable locking between the suture 7 and the clip 3. Thus, during the operation, when closing a large wound, the surgeon can quickly and reliably lock the hemostatic clips 1 one by one and ensure that all the hemostatic clips 1 are in a converged and locked state when the wound is closed. Compared to existing methods of closing wounds using hemostatic clips 1, this invention ensures that each hemostatic clip 1 experiences uniform force relative to the suture 7 during the entire wound contraction process. The tension of the wound tissue on the hemostatic clip 1 is also relatively uniform. When locked, each hemostatic clip 1 is independently constrained by the suture 7, effectively preventing it from collapsing into the wound and reducing the likelihood of dislodgement. This ensures a firm and stable clamping of the wound tissue. Furthermore, this invention eliminates the need to gather and secure all the hemostatic clips 1 with the suture 7, saving the time of tightening the suture 7 with auxiliary instruments and simplifying wound closure. It effectively avoids the problem of all the hemostatic clips collapsing into the wound during simultaneous gathering, thus eliminating the need for the surgeon to handle unexpected situations such as clip collapse or dislodgement during the operation, significantly improving surgical efficiency and safety.

[0062] As one implementation, in the locked state, the locking structure provides a frictional force of 0.3N to 9N to the suture 7. Within this range, it can ensure that the suture 7 is not easily dislodged from the locking structure, thus preventing locking failure, and also ensure that the operator can apply a certain force to pull the suture 7 out smoothly, without causing problems such as difficulty in pulling the suture 7 and difficulty in performing the operation due to excessive friction between the suture 7 and the locking structure.

[0063] In this embodiment, the locking structure is a slit 6 disposed on the side wall of the clamping part 4 and extending longitudinally. The locking structure can also be other structural forms, such as a circular through hole, an irregularly shaped through hole, or other irregularly shaped structures. As a specific implementation, the centerline of the slit 6 is collinear with the centerline of the clamping part 4 in the longitudinal extension direction. The slit 6 can be a strip shape with uniform width, and both longitudinal ends of the slit 6 have arc structures, such as... Figure 5 As shown, slit 6 can also be other shapes, such as... Figure 4 As shown. A frictional force of 0.1N to 15N, preferably not less than 0.3N, can be generated between the slit 6 and the suture 7 to achieve relative fixation of the clip 3 and the suture 7. The fit between the slit 6 and the suture 7 varies depending on the type of suture 7.

[0064] When the selected suture 7 is relatively soft and is a radially compressible material, such as silk or catgut, the suture 7 is interference-fitted with the slit 6. Figure 8As shown. Specifically, the width of the slit 6 is 0.10mm to 0.50mm, preferably 0.25mm to 0.35mm, and most preferably 0.3mm; the length of the slit 6 is 0.5mm to 5mm, preferably 1.2mm to 1.5mm, and most preferably 1.3mm; the diameter of the suture 7 is 0.10mm to 0.50mm, preferably 0.3mm to 0.4mm, and most preferably 0.35mm. After the suture 7 passes through the slit 6, the two longitudinal edges of the slit 6 laterally compress and deform the suture 7 (where longitudinal refers to the direction of extension from the proximal end to the distal end of the hemostatic clip 1, and lateral refers to the direction of extension from one side of the slit 6 to the other side and perpendicular to the longitudinal direction), thereby generating a frictional force of 0.1N to 15N, preferably not less than 0.3N, and fixing the relative position of the suture 7 and the hemostatic clip 1 through this frictional force. However, when the staff applies an external force along the axial direction of the slit 6 to the hemostatic clip 1 or the suture 7, the hemostatic clip 1 and the suture 7 can be displaced relative to each other, so as to achieve the purpose of threading the suture and gathering the hemostatic clip 1 in the slit 6; after the external force is removed, the suture 7 and the hemostatic clip 1 can maintain their relative positions based on the friction provided by the slit 6.

[0065] When the selected suture 7 is relatively stiff and is a radially incompressible material, such as nylon suture, the suture 7 fits into the slit 6 with a gap, such as... Figure 9 As shown. Specifically, the width of the slit 6 is 0.10mm to 0.50mm, preferably 0.25mm to 0.35mm, most preferably 0.3mm; the length is 0.5mm to 5mm, preferably 1.2mm to 1.5mm, most preferably 1.3mm; the diameter of the suture 7 is 0.08mm to 0.45mm, preferably 0.21mm to 0.27mm, most preferably 0.23mm; and the clearance between the diameter of the suture 7 and one side of the slit 6 is between 0.02mm and 0.04mm. Because the material of suture 7 is relatively hard, a certain assembly gap is required for suture 7 to pass through the slit 6 of clip 3. Although there is a gap between suture 7 and slit 6, the gap size is small. Under the premise of ensuring that suture 7 can pass through slit 6, when the hemostatic clip actually closes the wound, since the hemostatic clip is arranged along the circumference of the wound, the suture and the slit 6 in the hemostatic clip are not arranged completely parallel. Therefore, after suture 7 passes through slit 6, there will be a certain twisting and bending between suture 7 and slit 6. At this time, slit 6 will also generate a frictional force of 0.1N to 15N on suture 7, thereby completing the effective locking of suture 7.

[0066] As friction increases, the locking ability strengthens, but the difficulty of moving the suture 7 relative to the locking structure also increases accordingly. To facilitate the suture 7 passing through the locking structure of the clamping part 4, it is preferable to provide a threading structure 8 on the clamping part 4. This threading structure 8 can be a through hole, and the through hole is at least partially arc-shaped in the circumferential direction. As a preferred embodiment, such as... Figure 6 , Figure 7 As shown, in this embodiment, the threading structure 8 on the clamping part 4 is a near-circular through-hole structure, which facilitates matching with the cross-section of the suture 7. The maximum width of the threading structure 8 is greater than the diameter of the suture 7. The threading structure 8 transitions to the slit 6 via the connecting structure 11, allowing the threading structure 8 to communicate with the slit 6. The connecting structure 11 allows the suture 7 to move from the threading structure 8 into the slit 6 and lock in place. In use, the suture 7 is threaded through the threading structure 8. Because the maximum width of the threading structure 8 is greater than the diameter of the suture 7, the friction between the threading structure 8 and the suture 7 is small, facilitating threading and also facilitating the relative movement of the hemostatic clip 1 and the suture 7 when tightening the suture 7. After the hemostatic clip 1 is in place, the surgeon pulls the suture 7, causing the suture 7 to enter the slit 6 from the threading structure 8 through the connecting structure 11, thus locking the suture 7 and ensuring that the relative position of the suture 7 and the hemostatic clip 1 is fixed.

[0067] In this embodiment, the threading structure 8 is located at the longitudinal end (proximal and / or distal end) of the slit 6, or it can be located in the middle of the slit 6 (e.g., Figure 16 As shown). Figure 7 As shown, in this embodiment, the threading structure 8 is located near the end of the slit 6 in the longitudinal direction, that is, close to the tail 5 of the clip. The specific structural form of the threading structure 8 can be a circular hole, a square, or other irregular shape. As mentioned above, the slit 6 can be a strip shape with uniform width, or the slit 6 can be a shape with a gradually changing width along the extension direction, such as... Figure 4 As shown, the width of the slit 6 decreases as it moves further away from the tail 5, and its overall shape is trapezoidal or teardrop-shaped. If the threading structure 8 is located at one end of the slit 6 near the tail 5 and is connected to the slit 6, and if the threading structure 8 is also trapezoidal, and the width of the smaller diameter end of the threading structure 8 is the same as the width of the larger diameter section of the slit 6, then the threading structure 8 and the slit 6 are connected to form a strip-shaped slit (see also [reference]). Figure 4 However, in terms of function, it can still be distinguished into a threading structure 8 and a slit 6 with a locking function.

[0068] In this embodiment, in the communication direction between the threading structure 8 and the slit 6, an anti-detachment part 12 is provided on the wall of the communicating structure 11. The anti-detachment part 12 is used to prevent the suture 7 from moving from the slit 6 into the threading structure 8. Figure 10a As shown, in this embodiment, the anti-slip part 12 is a barb extending toward the slit 6; or, as... Figure 10bThe anti-detachment part 12 shown is an arc-shaped (or semi-arc-shaped, matching the structure according to the width of the slit 6 and the size and type of the suture 7) closing structure with a minimum width smaller than the maximum width of the slit 6. When the anti-detachment part 12 is a barb, it can be set on one or both sides of the wall of the connecting structure 11 in the longitudinal direction. This allows the suture 7 to enter the slit 6 from the threading structure 8, but makes it difficult for it to retract from the slit 6 back into the threading structure 8, thus preventing the suture 7 from retracting into the threading structure 8 under external force, which would cause the locking state with the hemostatic clip 1 to fail.

[0069] The anti-loosening part 12 can work well with the radially compressible flexible suture 7. When the suture 7 passes through the anti-loosening part 12 under the operation of the staff, it is compressed and then moved into the slit 6. However, it is difficult to return from the slit 6 to the threading structure 8 under a small external force, thus ensuring that the suture 7 is locked with the hemostatic clip 1.

[0070] In this embodiment, the edge of the slit 6 has a cutting blade 9 for cutting the suture 7, such as... Figures 11-13 As shown. After the suture 7 has tightened and locked the last hemostatic clip 1, the excess suture 7 can be cut off using the cutting blade 9. In actual use, the last hemostatic clip 1 in a circle can have the cutting blade 9, while the other hemostatic clips 1 do not, to avoid accidental cutting of the suture 7 during the process of passing through and tightening the slits 6 of the other hemostatic clips 1.

[0071] To prevent accidental cutting of the suture 7 during insertion and tightening of the last hemostatic clip 1 in the slit 6, this embodiment includes a suture locking area and a cutting area along the longitudinal extension direction of the slit 6, such as... Figure 13 As shown, a cutting edge 9 is provided on the edge of the cutting area. When the clamping part 4 has a threading structure 8, a threading locking area, and a cutting area simultaneously, the threading structure 8 and the threading locking area are arranged adjacent to each other. In this embodiment, the length of the cutting area is no greater than 1 / 2 of the length of the slit 6.

[0072] As another structure, the cutting blades 9 are arranged in a ring, and the sidewalls of the cutting blades 9 are arranged along the axial direction of the slit 6, such as... Figure 12As shown. The sidewall of the cutting blade 9 is inclined outward (the center of the slit 6 is the inner side), with an inclination angle not exceeding 90°. This facilitates cutting the suture 7 while preventing accidental cutting of the suture 7. The biggest technical challenge in the design of the cutting blade 9 in this invention lies in satisfying the need for the suture 7 to be reliably and securely locked with the locking structure of the clip 3 in the locked state, and for the cutting blade 9 on the clip 3 not to accidentally cut the suture 7 during tightening. At the same time, it is also necessary for the surgeon to quickly cut the suture 7 using the cutting blade 9 on the clip 3 when the wound is closed. Based on this, in this invention, the cutting blade 9 is inclined outward along the axis of the clip 3, i.e., towards the side in which the suture 7 is pulled out, so that the suture 7 does not come into contact with the edge of the cutting blade 9 in both the unlocked and locked states, thereby effectively preventing accidental cutting of the suture 7 during surgery.

[0073] In addition, such as Figure 14 As shown, in this embodiment, an outward-turned protrusion 10 is also provided at the slit 6, and the cutting blade 9 is provided on the outward-turned protrusion 10, so that the cutting blade 9 protrudes from the outer surface of the clip 3, further ensuring that in the event of accidental cutting of the suture 7, the cutting action can be completed more conveniently according to the needs of the operation under effective locking.

[0074] Example 2:

[0075] This embodiment also provides a hemostasis system, including a hemostasis clip 1 with locking suture function as in embodiment 1 and a suture 7. The suture 7 is used to pass through the locking structure of the hemostasis clip 1. Multiple hemostasis clips 1 are provided. The suture 7 passes through the locking structure. The suture 7 and the hemostasis clip 1 are locked together. Two hemostasis clips 1 locked together are arranged adjacent to each other.

[0076] In this embodiment, the locking structure is a slit 6 extending longitudinally.

[0077] In this embodiment, the suture 7 is a radially compressible soft suture. The suture 7 is interference-fitted with the slit 6, and the suture 7 is clamped by the longitudinal edges of the slit 6, applying a frictional force of 0.1N to 15N, preferably not less than 0.3N, thereby fixing the relative position of the suture 7 and the hemostatic clip 1.

[0078] In this embodiment, the suture 7 is a radially incompressible rigid suture. The suture 7 is fitted with the slit 6 with a gap. After the suture 7 passes through the slit 6, it is bent so that the surface of the suture 7 fits against the inner wall of the slit 6, so that the longitudinal edges of the slit 6 apply a frictional force of 0.1N to 15N to the suture 7, preferably not less than 0.3N, thereby fixing the relative position of the suture 7 and the hemostatic clip 1.

[0079] like Figure 15As shown, the delivery mechanism 13 in the hemostatic clip assembly of this embodiment may include an outer tube, a pull cable, a handle, and other structures. During operation, the handle can be used to control the opening and closing of the clip 3, clamping the tissue and closing the wound. The delivery mechanism 13 in this invention can adopt a conventional device, and this embodiment will not elaborate on its specific structure.

[0080] Any adaptive changes made according to actual needs are within the scope of protection of this invention.

[0081] Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this invention. Furthermore, those skilled in the art will recognize that, based on the ideas of this invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. A hemostatic clip with suture locking function, comprising a clip base and a clip piece, wherein the clip piece includes at least a distally extending clamping portion and a tail portion extending proximally into the clip base in the longitudinal extension direction, characterized in that: The clamping part is provided with a locking structure for the suture to pass through and for locking the suture; In the unlocked state, the suture can pass through the locking structure and move relative to the clamping part; in the locked state, the locking structure provides a frictional force of 0.1N to 15N to the suture.

2. The hemostatic clip with locking suture function according to claim 1, characterized in that, In the locked state, the locking structure provides a frictional force of 0.3N to 9N to the suture.

3. The hemostatic clip with locking suture function according to claim 1, characterized in that, The locking structure is a slit located on the side wall of the clamping part and extending longitudinally.

4. The hemostatic clip with locking suture function according to claim 3, characterized in that, The clamping part is also provided with a threading structure. The maximum width of the threading structure is greater than the diameter of the suture. The threading structure is connected to the slit through a connecting structure. The connecting structure allows the suture to move from the threading structure into the slit and be locked in place.

5. The hemostatic clip with locking suture function according to claim 4, characterized in that, The threading structure is arranged longitudinally on at least a portion of the slit.

6. The hemostatic clip with locking suture function according to claim 5, characterized in that, The threading structure is a through hole, and at least part of the through hole has an arc-shaped structure in the circumferential direction.

7. The hemostatic clip with locking suture function according to claim 4, characterized in that, In the communication direction between the threading structure and the slit, an anti-loosening part is provided on the wall of the communication structure to prevent the suture from moving from the slit into the threading structure.

8. The hemostatic clip with locking suture function according to claim 7, characterized in that, The anti-detachment part is a barb extending toward the slit; or, the anti-detachment part is an arc-shaped or semi-arc-shaped tapering structure with a minimum width smaller than the maximum width of the slit.

9. The hemostatic clip with locking suture function according to any one of claims 3 to 8, characterized in that, The edge of the slit has a cutting edge for cutting the suture.

10. The hemostatic clip with locking suture function according to claim 9, characterized in that, Along the longitudinal extension direction of the slit, the slit includes a thread-locking area and a cutting area, and the cutting edge of the cutting area is provided with the cutting blade.

11. The hemostatic clip with locking suture function according to claim 10, characterized in that, The length of the cutting area is no greater than 1 / 2 of the slit length.

12. The hemostatic clip with locking suture function according to claim 9, characterized in that, The slit is also provided with an outward-facing protrusion, and the cutting blade is provided on the outward-facing protrusion.

13. A hemostatic system, characterized in that, include: The hemostatic clip with locking suture function as described in any one of claims 1 to 12; and sutures, the sutures being threaded through the locking structure of the hemostatic clip; Multiple hemostatic clips are provided, and the sutures pass through the locking structure in sequence. The hemostatic clips are locked in sequence under the combined force of the suture tension and friction.

14. The hemostasis system according to claim 13, characterized in that, The locking structure is a slit, and the suture is a radially compressible soft thread that is interference-fitted with the slit.

15. The hemostasis system according to claim 13, characterized in that, The locking structure is a slit, and the suture is a radially incompressible rigid wire. The suture is fitted with the slit with a gap, and after the suture passes through the locking structure, it is bent so that the surface of the suture fits against the slit.

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