Front push release suture lock device

Abstract

The application provides a front push release type suture locking device for fixing a suture in a locking nail, comprising a collet and a push rod assembly sleeved outside the collet; the locking nail is accommodated in the distal end of the collet, and the collet itself is elastic; the push rod assembly comprises a push rod, one side of the push rod facing the collet is provided with a recess, and the side of the collet facing the push rod is provided with a protrusion corresponding to the recess; in the process of continuously moving the push rod in the axial direction to the distal end, the push rod first pushes the side of the protrusion gradually rising to force the collet to compress the locking nail to deform and lock the suture; then the protrusion is gradually accommodated in the recess, so that the collet at least recovers part of the deformation to release the locking nail. The front push release type suture locking device can avoid the violent jumping of the collet when releasing the locking nail, and greatly reduces the risk of tearing the tissue.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a push-release type suture locking device. Background Technology

[0002] In surgery, tying and securing sutures is a frequent procedure. Traditional surgery is performed under direct visualization, and the knots are usually tied manually by the surgeon. However, with technological advancements, minimally invasive and interventional surgeries are becoming increasingly common, such as laparoscopic surgery and transcatheter interventional procedures. These surgeries only require a small incision in the patient's body to insert instruments such as endoscopes or interventional catheters to reach the intended treatment site. In these procedures, tying or securing sutures within the patient's body typically requires the operator to perform the procedure from outside the patient's body through the small incision. This necessitates the use of suture locking devices.

[0003] An existing suture locking device includes a locking pin with a hollow inner cavity, a clamp that matches the locking pin and applies pressure to the locking pin to force it to deform, and a push rod connected to the clamp and providing driving force to the clamp. A suture is threaded through the hollow inner cavity of the locking pin. By pushing the push rod axially towards the distal end of the clamp, the clamp is driven to press and shape the locking pin to lock the suture. After the locking pin is pressed, the push rod is pulled axially in the opposite direction, causing the push rod to gradually move away from the clamp, thereby releasing the force exerted by the push rod on the clamp and allowing the clamp to release the locking pin. Figure 1 As shown, because the direction of the force when the chuck presses the locking pin is opposite to the direction of the force when the locking pin is released, the force curve of the push rod has a cliff-like jump in both directions, and the force on the chuck also has a cliff-like jump; at the moment when the push rod is pulled back and the chuck releases the locking pin, the push rod will cause the chuck and locking pin to jump violently, which will forcefully tear the sutured tissue, and the risk of the tissue being torn is high. Summary of the Invention

[0004] The purpose of this invention is to address the shortcomings of existing technologies by providing a forward-release suture locking device that can avoid the violent jumping of the clamp release locking pin at the moment of release, thus significantly reducing the risk of tissue tearing.

[0005] To address the aforementioned technical problems, this invention provides a push-release type suture locking device, comprising a clamp and a push rod assembly sleeved outside the clamp; the push rod assembly includes a push rod, a recessed portion on the side of the push rod facing the clamp, and a protrusion corresponding to the recessed portion on the side of the clamp facing the push rod; the clamp itself is elastic, and a locking pin through which the suture is inserted is housed within the clamp; as the push rod moves axially towards the distal end, the push rod first pushes against the side of the gradually rising protrusion, forcing the clamp to compress and deform the locking pin to lock the suture; then the protrusion is gradually accommodated within the recessed portion, causing the clamp to at least partially recover its deformation, thereby releasing the locking pin.

[0006] The push-release suture locking device provided in this application has a recessed portion on the clamp and a protrusion on the push rod. During the continuous axial push of the push rod towards the distal end, the push rod first pushes against the side of the gradually rising protrusion of the clamp, forcing the clamp to compress and deform the locking pin to lock the suture inserted in the locking pin. Then, the protrusion gradually accommodates the recessed portion, and the clamp at least partially recovers its deformation to release the locking pin. That is, the compression and release of the locking pin are implemented by continuously pushing the push rod. The continuous pushing ensures the continuity of force on the push rod and the clamp, which can avoid violent jumping at the moment the clamp releases the locking pin and prevent the clamp and locking pin from tearing the sutured tissue, thereby greatly reducing the risk of tissue tearing. Attached Figure Description

[0007] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0008] Figure 1 This is a schematic diagram showing the relationship between the force and stroke of the push rod during the pressing and releasing of the locking pin in the existing technology.

[0009] Figure 2 This is a three-dimensional structural schematic diagram of the push-release type suture locking device provided in the first embodiment of the present invention.

[0010] Figure 3 yes Figure 2 A cross-sectional view along line III-III.

[0011] Figure 4 yes Figure 3 Enlarged view of section IV.

[0012] Figure 5This is a three-dimensional structural diagram of the locking pin squeezed by the clamp of the push-release type suture locking device provided in the first embodiment of the present invention.

[0013] Figure 6 yes Figure 5 A cross-sectional view of the locking pin.

[0014] Figure 7 yes Figure 5 A cross-sectional view of the locking pin after it has been pressed.

[0015] Figure 8 yes Figure 4 A cross-sectional view of the clamp in the diagram.

[0016] Figure 9 yes Figure 8 A schematic diagram of the deformation state of the chuck in the middle.

[0017] Figure 10 yes Figure 4 A three-dimensional structural diagram of the push rod assembly in the diagram.

[0018] Figure 11 yes Figure 10 A cross-sectional view of the push rod assembly.

[0019] Figure 12 yes Figure 2 A cross-sectional view of the push rod assembly and transmission assembly in the image.

[0020] Figure 13 yes Figure 2 A sectional view of the chuck, push rod assembly, transmission assembly, and drive component.

[0021] Figure 14 yes Figure 13 Enlarged view of the chuck, push rod assembly and some transmission components.

[0022] Figure 15 yes Figure 2 A three-dimensional structural diagram of the handle and outer support tube assembly.

[0023] Figure 16 yes Figure 15 A cross-sectional view of part of the handle and outer support tube assembly.

[0024] Figure 17 - Figure 19 This is a schematic diagram of the valve repair process of a diseased tricuspid valve using the push-release type suture locking device provided in the first embodiment of the present invention.

[0025] Figure 20 yes Figure 19 Enlarged view of section XX.

[0026] Figure 21 - Figure 23 This is a schematic diagram illustrating the process by which the push-release type suture locking device provided in the first embodiment of the present invention fixes the suture inside the locking pin.

[0027] Figure 24 This is a schematic diagram showing the relationship between the force and stroke of the push rod during the clamping and releasing process of the locking pin of the present invention.

[0028] Figure 25 This is a schematic diagram of the structure of the push-release type suture locking device provided in the second embodiment of the present invention. Detailed Implementation

[0029] 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.

[0030] Furthermore, the following descriptions of the embodiments are made with reference to the accompanying illustrations to illustrate specific embodiments in which the invention can be implemented. Directional terms used in this invention, such as "up," "down," "front," "rear," "left," "right," "inner," "outer," and "side," are merely directional references to the accompanying illustrations. Therefore, the directional terms used are for better and clearer explanation and understanding of the invention, and are not intended to indicate or imply that the referred device or element must have a specific orientation, or be constructed and operated in a specific orientation; therefore, they should not be construed as limitations on the invention.

[0031] Orientation definition: For clarity of description, the end of the instrument closer to the operator during the operation is referred to as the "proximal end" and the end farther from the operator is referred to as the "distal end"; the axis refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical instrument; the above definitions are only for convenience of expression and should not be construed as limiting the present invention.

[0032] Please see Figures 2 to 4 The first embodiment of the present invention provides a push-release type suture locking device 100 for locking a suture to a locking pin 300. The push-release type suture locking device 100 includes a clamp 22 at the distal end for compressing and deforming the locking pin 300, a push rod assembly 40 sleeved outside the clamp 22 for controlling the opening and closing of the clamp 22, a transmission assembly 60 connected to the push rod assembly 40, a drive member 70, a support tube assembly 80 surrounding the clamp 22, the push rod assembly 40, and the transmission assembly 60, and a handle 90 at the proximal end. The distal end of the clamp 22 has a gap 25 for placing the locking pin 300 (see...). Figure 8As shown), the locking pin 300 has a thread-passing cavity 301 along its axial direction, which is used to pass through the suture thread. The push rod assembly 40 includes a push rod 42 disposed outside the clamp 22. The push rod 42 has a recess 420 on the side facing the clamp 22. The axial position of the clamp 22 is fixed and it is elastic. The side of the clamp 22 facing the push rod 42 has a protrusion 220 corresponding to the recess 420. The transmission assembly 60 includes a threaded transmission member 62 and a flexible inner core 63 with a certain axial length fixedly connected to the threaded transmission member 62. The distal end of the threaded transmission member 62 is rotatably connected to the push rod assembly 40. The flexible inner core 63 rotates to drive the threaded transmission member 62 to rotate. The rotation of the threaded transmission member 62 drives the push rod assembly 40 to rotate. The rod assembly 40 moves axially toward the distal end, causing the push rod 42 to move axially toward the distal end to push against the side of the gradually rising protrusion 220 of the collet 22, thereby forcing the collet 22 to compress the locking pin 300 and lock the suture thread passing through the locking pin 300; the flexible inner core 63 continues to rotate in the same direction to drive the threaded transmission member 62 to rotate, and the rotation of the threaded transmission member 62 drives the push rod assembly 40 and the push rod 42 to continue moving axially toward the distal end until the protrusion 220 of the collet 22 is gradually accommodated in the recess 420, so that the collet 22 at least partially recovers its deformation to release the locking pin 300.

[0033] The push-release type suture locking device 100 provided in this application, during the continuous axial pushing of the push rod 42 towards the distal end, the push rod 42 first pushes against the side of the gradually rising protrusion 220 of the clamp 22, so as to force the clamp 22 to compress and deform the locking pin 300 and lock the suture passing through the locking pin 300. Then, the protrusion 220 on the clamp 22 gradually accommodates the recess 420 of the push rod 42, and the clamp 22 at least partially recovers its deformation to release the locking pin 300. That is, the compression and release of the locking pin 300 are implemented by continuously pushing the push rod 42, and the continuous pushing ensures the continuity of force on the push rod 42 and the clamp 22 (e.g., Figure 24 As shown, this design avoids the violent jumping of the clamp 22 when releasing the locking pin 300, preventing the clamp 22 and locking pin 300 from tearing the sutured tissue, such as the leaflet, thus significantly reducing the risk of tissue tearing.

[0034] Furthermore, as the push rod 42 is pushed axially towards the distal end to push against the gradually rising side of the protrusion 220 of the clamp 22, the resistance gradually increases during the pressing of the locking stud 300, and the driving force required by the push rod 42 increases accordingly. When the push rod 42 continues to be pushed axially towards the distal end and passes the highest point of the protrusion 220, the protrusion 220 is gradually accommodated in the recess 420, the resistance gradually decreases, and the driving force required by the push rod 42 decreases accordingly. Thus, the operator can know whether the locking stud 300 has been pressed and whether the stitch has been locked by the perception of the operating feel.

[0035] On the other hand, the forward-release type suture locking device 100 converts the rotational torque of the flexible inner core 63 and the threaded transmission member 62 into an axial thrust that drives the push rod 42 to move axially, thereby driving the push rod 42 to advance axially to the far end. Since the threaded transmission member 62 is rigid and short in length, the thrust loss is minimal, and the thrust can be smoothly and effectively transmitted to the push rod 42 to push the clamp 22. Thus, the clamp 22 can effectively compress the locking pin 300 so that the locking pin 300 is fully deformed, ensuring that the suture is reliably locked by the locking pin 300.

[0036] like Figure 3 and Figure 4 As shown, the outer support tube assembly 80 includes a sleeve 82 for housing the chuck 22 and the push rod assembly 40, an end cap 88 fixed to the distal end of the sleeve 82, a connecting tube 84 fixed to the proximal end of the sleeve 82, and a flexible outer tube 86 fixed to the proximal end of the connecting tube 84. A threaded drive member 62 is rotatably connected to the outer sleeve assembly 80, and the threaded drive member 62 rotates relative to the outer sleeve assembly 80 to drive the push rod 42 to move axially. The sleeve 82 houses the chuck 22 and the push rod assembly 40, and the chuck 22 is fixedly connected to the sleeve 82 to fix the axial position of the chuck 22. The flexible outer tube 86 is sleeved outside the flexible inner core 63. The threaded drive member 62 is rotatably connected to the connecting tube 84; specifically, the threaded drive member 62 and the connecting tube 84 are driven by a threaded engagement. In this embodiment, the threaded transmission component 62 is a transmission screw, and a connecting part 67 is provided at the distal end of the threaded transmission component 62. The connecting part 67 is rotatably connected to the push rod assembly 40. The threaded transmission component 62 rotates synchronously and moves axially to drive the push rod assembly 40 to move axially.

[0037] like Figure 4 As shown, the distal end of the flexible outer tube 86 is fixedly connected to the proximal end of the connecting cylinder 84. The connecting cylinder 84 is fixedly connected between the sleeve 82 and the flexible outer tube 86. The proximal end of the flexible outer tube 86 is fixedly connected to the distal end of the handle 90. The inner cavity of the flexible outer tube 86 communicates with the inner cavity of the connecting cylinder 84. The connecting cylinder 84 is screwed to the threaded transmission component 62. The flexible outer tube 86 is a tube with a certain supporting force, preferably a laser-cut outer tube, a spiral structure, or a braided mesh structure. In this embodiment, the flexible outer tube 86 is a laser-cut outer tube. The flexible outer tube 86 can be made of materials such as stainless steel, nickel-titanium alloy, or cobalt-chromium alloy. In this embodiment, the flexible outer tube 86 is made of nickel-titanium alloy.

[0038] Sleeve 82 is a hollow tube. The proximal end of sleeve 82 is engaged with the distal end of connecting sleeve 84, and the distal end of sleeve 82 is engaged with end cap 88. A threading groove 820 is formed on the peripheral wall of sleeve 82 near clamp 22, through which the suture thread inserted in locking pin 300 exits. A suture inlet 880 is formed at the distal end of end cap 88, communicating with the inner cavity of sleeve 82. Locking pin 300 is inserted into the inner cavity of sleeve 82 through suture inlet 880.

[0039] Please see Figure 5 and Figure 6 The locking pin 300 includes a locking sleeve 302 and a frustum 303 located at the distal end of the locking sleeve 302. The outer diameter of the frustum 303 of the locking pin 300 is larger than the outer diameter of the locking sleeve 302. The suture cavity 301 of the locking pin 300 passes through the opposite ends of the locking pin 300 axially, and the suture cavity 301 is used to receive and pass the suture. When the locking sleeve 302 is subjected to mechanical force, it can be crushed to fix the suture in the suture cavity 301 of the locking pin 300. The locking pin 300 can be of various shapes, such as cylindrical, prismatic, elliptical, etc., as long as it has a suture cavity 301 for receiving the suture. The distal opening of the suture cavity 301 of the locking pin 300 has a smooth transition with the distal end face of the locking pin 300 to avoid cutting the suture or scratching the patient's internal tissues at the connection point. Locking nails 300 are made of biocompatible materials such as stainless steel, pure titanium, nickel-titanium, and cobalt-chromium alloys, with pure titanium or stainless steel being preferred.

[0040] In this embodiment, as Figure 6 As shown, when the locking pin 300 is not compressed by external force, the initial height h1 of the middle part of the locking pin 300 is equal to the outer diameter of the locking sleeve 302 of the locking pin 300; as Figure 6 As shown, when the locking sleeve 302 of the locking pin 300 is crushed under the action of mechanical external force, the suture is fixed in the thread-passing cavity 301 of the locking pin 300. At this time, the height h2 of the locking pin 300 after being crushed is less than the initial height h1.

[0041] To improve the connection between the locking pin 300 and the suture after being gripped, an anti-slip structure can be provided on the inner circumferential surface of the threading cavity 301, such as anti-slip texture or roughening treatment. After the locking pin 300 is deformed by external gripping force, the friction between the suture and the inner circumferential surface of the threading cavity 301 increases, making the suture more firmly fixed in the threading cavity 301 of the locking pin 300.

[0042] Please see Figure 8 and Figure 9 The chuck 22 includes an integrally formed first chuck 221 and a second chuck 223 disposed opposite to each other. A protrusion 220 is provided on the side of the first chuck 221 away from the second chuck 223. A gap 25 is formed between the first chuck 221 and the second chuck 223. When the drive member 70 drives the threaded transmission member 62 to rotate, since the position of the connecting cylinder 84 is fixed, the threaded transmission member 62 rotates and moves axially, pushing the push rod 42 to move axially. That is, the rotation of the threaded transmission member 62 is converted into the axial movement of the push rod 42, so that the push rod 42 slides against the protrusion 200 of the chuck member 22, thereby driving the first chuck 221 and the second chuck 223 to move towards each other and squeeze the locking pin 300, so that the locking pin 300 deforms and is fixed to the sewing line.

[0043] In this embodiment, the first chuck 221 and the second chuck 223 are integrally formed from a rigid material with elasticity. The proximal end of the chuck 22 is closed, and a pin 24 perpendicular to the axial direction passes through the proximal end of the chuck 22. Both ends of the pin 24 are fixed to the sleeve 82. The pin 24 positions the chuck 22 and prevents the chuck 22 from moving axially. The solid portion connecting the proximal ends of the first chuck 221 and the second chuck 223 provides support and power for the rebound of the first chuck 221.

[0044] In this embodiment, the protrusion 220 is located at the distal end of the first clamp 221 on the side opposite to the second clamp 223. The protrusion 220 includes intersecting first outer inclined surfaces 2201 and second outer inclined surfaces 2203. The first outer inclined surfaces 2201 and second outer inclined surfaces 2203 intersect on the side away from the second clamp 223. The first outer inclined surface 2201 gradually rises from its proximal end to its distal end, and the second outer inclined surface 2203 gradually decreases from its proximal end to its distal end. Figure 4 and Figure 9 As shown, the first outer inclined surface 2201 corresponds to the side of the protrusion 220 that gradually rises. The distal end of the push rod 42 slides axially against the first outer inclined surface 2201 to compress the first chuck 221 towards the second chuck 223, thereby pressing the locking pin 300. The push rod 42 continues to be pushed distally until the protrusion 220 is gradually accommodated within the recess 420. The chuck 22 springs back, the first chuck 221 moves away from the second chuck 223, and the gap between the first chuck 221 and the second chuck 223 increases to a height h2 greater than the compressed height of the locking pin 300, thus releasing the locking pin 300. Further, the distal end of the first chuck 221 has a first clamping tooth 2215 on the side facing the gap 25. The first clamping tooth 2215 includes several grooves, each extending approximately perpendicular to the axial direction.

[0045] like Figure 8The first outer inclined surface 2201 is located at the proximal end of the protrusion 220, and extends gradually from its proximal end toward the distal end, tilting away from the second clamp 223. The second outer inclined surface 2203 is located at the distal end of the protrusion 220, and extends gradually from its proximal end toward the distal end, tilting toward the side closer to the second clamp 223. The first outer inclined surface 2201 and the second outer inclined surface 2203 of the protrusion 220 form an angle α, preferably 120° ≤ α < 180°. Furthermore, when the chuck 22 is in its initial state (or natural state, meaning the state before the chuck 22 is pushed by the push rod 42), the first included angle a1 between the first outer inclined surface 2201 and the vertical plane L perpendicular to the axial direction has a range of 70°≤a1<90°, and the second included angle a2 between the second outer inclined surface 2203 and the vertical plane L perpendicular to the axial direction has a range of 50°≤a2<90°. The sum of the first included angle a1 and the second included angle a2 is equal to the included angle α between the first outer inclined surface 2201 and the second outer inclined surface 2203. It is worth noting that a2<a1, or in other words, the slope of the first outer inclined surface 2201 is less than the slope of the second outer inclined surface 2203. The slope of the first outer inclined surface 2201 is gentler, which helps to reduce the driving force of pushing the push rod 42 to push and compress the chuck 22, allowing the chuck 22 to deform gradually.

[0046] like Figure 8 As shown, the height difference H1 between the distal and proximal ends of the first outer bevel 2201 is greater than or equal to the diameter of the inner hole of the locking sleeve 302 of the locking pin 300, i.e., the thread-passing cavity 301, and less than the outer diameter of the locking sleeve 302 of the locking pin 300. This allows the first clamp 221 and the second clamp 223 to fully press the locking pin 300 when the push rod 42 pushes against the distal end of the first outer bevel 2201, so as to lock the suture thread passing through the locking pin 300.

[0047] Please refer to the following: Figure 8 and Figure 9 The height difference H between the highest point of the protrusion 220 before deformation of the first collet 221 and after deformation and springback is less than the difference between the initial height h1 and the collapsed height h2 of the locking pin 300. Specifically, the vertical length between the highest point of the protrusion 220 before deformation of the first collet 221 and the axial plane of the axis of the pin 24 is H2 (e.g., Figure 8 As shown), after the first collet 221 recovers from compression, the protrusion 220 is housed within the recess 420 of the push rod 42. At this time, the vertical length between the highest point of the protrusion 220 and the axial plane of the pivot pin 24 is H3 (as shown). Figure 9As shown), H2 minus H3 gives the height difference H. The height difference H is less than the difference between the initial height h1 of the locking pin 300 before pressing and the height h2 of the locking pin 300 after being flattened, so as to facilitate the locking pin 300 to smoothly disengage from the gap 25 of the chuck 22. When the difference H is 0, the first chuck 221 is completely restored to its initial state.

[0048] The intersection of the first outer inclined surface 2201 and the second outer inclined surface 2203 is rounded to facilitate the smooth passage of the push rod 42 across the intersection of the first outer inclined surface 2201 and the second outer inclined surface 2203, thus facilitating the smooth sliding of the push rod 42 from the first outer inclined surface 2201 to the second outer inclined surface 2203.

[0049] The second chuck 223 has a second clamping tooth 2235 near its distal end on the side facing the first chuck 221. The second clamping tooth 2235 includes a plurality of tooth grooves, and the extending direction of each tooth groove of the second clamping tooth 2235 is the same as the extending direction of the tooth groove of the first clamping tooth 2215. When the first chuck 221 and the second chuck 223 approach each other along the pin 24, the first clamping tooth 2215 of the first chuck 221 and the second clamping tooth 2235 of the second chuck 223 are misaligned and can mesh with each other. Therefore, the first chuck 221 elastically deforms and moves towards the second chuck 223. The first clamping tooth 2215 and the second clamping tooth 2235 compress the locking pin 300 placed in the gap 25 into a curved shape. The second clamp 223 has a horizontal guide surface 2236 on its proximal end opposite to the side of the first clamp 221. A threading hole 2237 with a connecting gap 25 is provided on the guide surface 2236 to facilitate the suture thread after passing through the locking pin 300 to exit through the threading hole 2237. A positioning block 2233 is protruding from the distal end of the second clamp 223 opposite to the side of the first clamp 221. The proximal end face of the positioning block 2233 is close to the threading hole 2237 and is a tangential surface 2238.

[0050] Please refer to the following: Figure 4 and Figure 10 - Figure 11 The push rod assembly 40 also includes a base 44 axially movably inserted into the sleeve 82 and a tangent blade 46 fixedly connected to one side of the base 44. The proximal end of the push rod 42 is fixedly connected to the other side of the base 44 opposite to the tangent blade 46, and the push rod 42 extends axially to the distal end. The connecting part 67 is rotatably connected to the base 44, and an axial limiting structure is provided between the connecting part 67 and the base 44. The tangent blade 46 and the push rod 42 are spaced apart and opposite to each other, and the tangent blade 46 slides axially on the guide surface 2236.

[0051] A recess 420 is located on the side of the push rod 42 close to the first collet 221 and near the distal end of the push rod 42. The recess 420 includes an intersecting first inner inclined surface 4201 and a second inner inclined surface 4203, with the first inner inclined surface 4201 being further away from the distal end face of the push rod 42 than the second inner inclined surface 4203. When the protrusion 220 is accommodated within the recess 420, the first outer inclined surface 2201 corresponds to the first inner inclined surface 4201, and the second outer inclined surface 2203 corresponds to the second inner inclined surface 4203.

[0052] like Figure 11 As shown, the first inner inclined surface 4201 gradually extends from its proximal end to the distal end, tilting away from the first chuck 221, while the second inner inclined surface 4203 gradually extends from its proximal end to the distal end, tilting towards the first chuck 221. The distal edge of the second outer inclined surface 4203 is rounded to allow the push rod 42 to slide smoothly against the second outer inclined surface 2203; the distal surface of the push rod 42 and the surface of the push rod 42 close to the chuck 22 are also rounded to allow the push rod 42 to slide smoothly against the first outer inclined surface 2201.

[0053] The angle b between the first inner inclined surface 4201 and the second inner inclined surface 4203 of the recess 420 is greater than or equal to the angle a between the first outer inclined surface 2201 and the second outer inclined surface 2203 of the protrusion 220, so that the protrusion 220 can be accommodated within the recess 420. Preferably, the third angle b1 between the first inner inclined surface 4201 and the vertical surface O perpendicular to the axial direction is greater than or equal to the first angle a1, and the fourth angle b2 between the second inner inclined surface 4203 and the vertical surface O perpendicular to the axial direction is greater than or equal to the second angle a2; the sum of the third angle b1 and the fourth angle b2 is equal to the angle b between the first inner inclined surface 4201 and the second inner inclined surface 4203.

[0054] like Figure 11 As shown, the maximum depth H4 of the recess 420 is the vertical length between the highest point of the recess 420 and the surface of the push rod 42 close to the chuck 22. The maximum depth H4 is greater than or equal to the height difference H1 between the far end and the near end of the first outer inclined surface 2201, or the maximum height of the protrusion 220, to ensure that the protrusion 220 can be completely accommodated in the recess 420, providing sufficient rebound space for the chuck 22. When the protrusion 220 is accommodated in the recess 420, the height of the gap 25 is greater than the height h2 of the locking pin 300 after it is compressed, so as to facilitate the release of the locking pin 300.

[0055] The distal end of the tangent blade 46 is provided with a cutting edge 461. When the protrusion 220 is fully accommodated in the recess 420, the cutting edge 461 abuts against the tangent surface 2238 to cut the suture thread passing through the thread hole 2237.

[0056] It is understood that in other embodiments, the protrusion 220 may also be a protrusion in the shape of a hemisphere, a frustum, a cone, etc., and the recess 420 may also be a groove or gap in the shape of a hemisphere, a frustum, a cone, etc., that is adapted to the protrusion 220.

[0057] Please refer to the following: Figure 3 , Figure 4 and Figure 12 - Figure 14 The flexible inner core 63 includes a flexible inner tube 64 connected to the proximal end of the threaded transmission member 62 and a core rod 66 inserted into the inner cavity of the flexible inner tube 64. A connecting part 67 connects the distal end of the threaded transmission member 62 and the base 44 of the push rod assembly 40. The flexible inner tube 64 is wound around the core rod 66, and the flexible inner tube 64 and the core rod 66 together constitute the flexible inner core 63. The threaded transmission member 62 includes a transmission screw 621, which is screwed into the internal thread of the connecting cylinder 84. The distal end of the flexible inner tube 64 is fixedly connected to the threaded transmission member 62, and the proximal end of the flexible inner tube 64 is fixedly connected to the driving member 70. The driving member 70 is used to drive the flexible inner core 63 and the threaded transmission member 62 to rotate. The flexible inner tube 64 is a tube with a certain supporting force, preferably a spiral structure or a braided mesh structure, and can be made of materials such as stainless steel, nickel-titanium alloy, or cobalt-chromium alloy. The outer diameter of the flexible inner tube 64 is smaller than the inner diameter of the flexible outer tube 86. The rotation of the flexible inner tube 64 relative to the connecting cylinder 84 can drive the threaded transmission component 62 to rotate and move axially.

[0058] The core rod 66 is inserted into the inner cavity of the flexible inner tube 64. The core rod 66 is a flexible mandrel. Preferably, the core rod 66 can be made of materials such as stainless steel, nickel-titanium alloy, or cobalt-chromium alloy. The core rod 66 facilitates the winding of wires to form the flexible inner tube 64 and enhances the torsional control of the flexible inner core 63.

[0059] The transmission screw 621 rotates and moves axially to drive the connecting part 67 to rotate relative to the base 44. At the same time, the distal end of the transmission screw 621 pushes against the base 44, the push rod 42 and the tangent blade 46 to move axially toward the distal end.

[0060] In other embodiments, the connecting part 67 may also be fixedly connected to the push rod assembly 40, the connecting part 67 may be rotatably connected to the threaded transmission member 62, and a limiting structure is provided between the connecting part 67 and the threaded transmission member 62 to prevent the connecting part 67 from moving axially relative to the threaded transmission member 62, so that the connecting part 67 and the threaded transmission member 62 are rotatably connected.

[0061] like Figure 3 and Figure 13As shown, the drive component 70 is connected to the proximal end of the transmission assembly 60. Specifically, the drive component 70 is a rotating component rotatably disposed at the proximal end of the handle 90. The proximal ends of the flexible inner tube 64 and the core rod 66 are fixedly connected to the drive component 70. The rotation of the drive component 70 causes the flexible inner tube 64 and the core rod 66 to rotate together. An anti-slip mechanism 79 is provided on the outer wall of the drive component 70, which facilitates rotation of the drive component 70 by gripping it.

[0062] Please refer to the following: Figure 2 , Figure 3 and Figure 15 , Figure 16 The drive member 70 is rotatably connected to the proximal end of the handle 90. At least one length scale 915 is axially provided on the handle 90 near the drive member 70, indicating the amount of axial displacement of the drive member 70. When the distal end face of the drive member 70 is aligned with 0 on the length scale 915, the first chuck 221 and the second chuck 223 of the chuck 22 are fully open, and the push rod 42 does not apply any axial thrust to the chuck 22. When the drive member 70 rotates and moves axially until its distal end face is aligned with a certain scale value on the length scale 915, such as "6", the push rod 42 pushes against the highest point of the protrusion 220 of the chuck 22, and the first chuck 221 and the second chuck 223... The two clamps 223 compress and deform the locking pin 300 to fix the suture thread passing through the locking pin 300; when the drive member 70 continues to rotate in the same direction and moves axially until its far end face is aligned with another scale value on the length scale 915, such as "7.5", the protrusion 220 on the clamp 22 is accommodated in the recess 420 of the push rod 42, and the first clamp 221 of the clamp 22 elastically resets and moves away from the second clamp 223, which facilitates the release of the locking pin 300.

[0063] Please see Figures 17 to 23 The following uses tricuspid valve repair surgery as an example to illustrate the usage process of the anterior release type suture locking device 100 provided by the present invention.

[0064] The tricuspid valve is a one-way valve between the right atrium (RA) and the right ventricle (RV), ensuring blood flows from the right atrium to the right ventricle. A normal, healthy tricuspid valve has multiple chordae tendineae. The leaflets of the tricuspid valve are divided into anterior, posterior, and septal leaflets. When the right ventricle is in diastole, all three leaflets are open, allowing blood to flow from the right atrium to the right ventricle. When the right ventricle is in systole, the chordae tendineae are stretched, preventing the leaflets from being pushed into the atrium by the blood flow. The anterior, posterior, and septal leaflets close properly, ensuring blood flows from the right ventricle through the pulmonary valve (PV) to the pulmonary artery. If the tricuspid valve is diseased, when the right ventricle is in systole, the tricuspid valve cannot return to a completely closed state as it normally would, resulting in incomplete closure. The force of the blood flow can further cause the leaflets to dislodge into the right atrium, causing blood to flow back. For tricuspid regurgitation, sutures can be implanted into each leaflet via interventional procedures. Then, the locking device of this invention is used to lock the sutures on each leaflet together to achieve edge-to-edge repair. The specific process is as follows:

[0065] Step 1: As Figure 17 As shown, one or more sutures 500 with elastic pads 501 are first implanted into the anterior leaflet, posterior leaflet and septal leaflet of the patient's tricuspid valve. The point contact between the suture 500 and the leaflet is changed to the surface contact between the elastic pad 501 and the leaflet, which can effectively reduce the risk of leaflet tear.

[0066] Step 2: As Figure 17 and Figure 21 As shown, outside the patient's body, multiple sutures 500 on the three leaflets are inserted into the threading cavity 301 of the locking pin 300 of the push-release type suture locking device 100, and the proximal end of the suture 500 is sequentially passed through the threading cavity 301 of the locking pin 300, the gap 25 between the first clamp 221 and the second clamp 223, and the threading hole 2237, and then out through the threading groove 820 of the sleeve 82;

[0067] Step 3: Using the bending sheath (not shown in the figure), push the distal end of the forward-release suture locking device 100 into the right atrium of the heart via the femoral vein, move it closer to the leaflet of the tricuspid valve, and at the same time pull the suture 500 until the distal end of the forward-release suture locking device 100 reaches the predetermined position in the right atrium.

[0068] Step 4: Adjust the tightness of the three leaflet sutures 500mm apart, namely the anterior, posterior and septal leaflets. At the same time, use ultrasound to determine the state of the mildest tricuspid regurgitation. When this state is reached, stop adjusting and maintain the tightness of the three sets of sutures 500mm apart, that is, maintain the relative position between the anterior leaflet, posterior leaflet and septal leaflet of the tricuspid valve.

[0069] Step 5: As Figure 18 and Figure 22As shown, the drive member 70 and the threaded transmission member 62 on the rotating handle 90 move axially to the distal end while rotating, driving the drive member 70, the flexible inner core 63 and the threaded transmission member 62 to rotate and move axially to the distal end. The threaded transmission member 62 pushes the push rod assembly 40 to move axially to the distal end. During the process of the push rod assembly 40 moving axially to the distal end, the push rod 42 moves relative to the chuck 22 to the distal end. The distal end of the push rod 42 continuously pushes and squeezes the first outer inclined surface 2201 on the first chuck 221 until it reaches the highest point of the protrusion 220, so that the first chuck 221 moves closer to the second chuck 223. The first clamping teeth 2215 and the second clamping teeth 2235 grip the locking pin 300 contained in the gap 25 until the locking pin 300 is deformed, locking the three sets of stitching threads 500 in the locking pin 300 together.

[0070] Step 6: As Figure 19 , Figure 20 and Figure 23 As shown, the drive member 70 on the handle 90 continues to rotate in the same direction of rotation, the threaded transmission member 62 continues to move axially to the distal end, and the drive push rod 42 continues to move distally until the protrusion 220 on the first clamp 221 enters the recess 420 of the push rod 42, the clamp 22 releases the locking pin 300, the suture blade 46 cuts the suture 500, and the locking pin 300 is released from the gap 25 of the clamp 22; then the excess suture 500 is pulled out of the patient's body through the locking path;

[0071] Step 7: Remove the distal end of the locking device 100 from the patient's body, leaving the locking pin 300 inside the patient's body. At this time, the locking pin 300 fixes the three sets of sutures that pass through the anterior leaflet, posterior leaflet and septum leaflet together, and the anterior leaflet, posterior leaflet and septum leaflet of the tricuspid valve are repaired.

[0072] It is understood that the above description only illustrates the use of the push-release suture locking device in interventional tricuspid valve repair procedures. The push-release suture locking device of the present invention can also be used to lock and fix sutures in other surgical procedures.

[0073] Please see Figure 25 The structure of the push-release type suture locking device provided in the second embodiment of the present invention is similar to that of the first embodiment, except that the structure of the push rod assembly 40a and the threaded transmission component 62a in the second embodiment is slightly different from that in the first embodiment, and the connection structure between the push rod assembly 40a and the threaded transmission component 62a is slightly different from that in the first embodiment, as detailed below:

[0074] The push-release type suture locking device in the second embodiment also includes a clamp 22, a push rod assembly 40a, a transmission assembly and an outer sleeve assembly 80a. A threaded transmission member 62a is rotatably connected to the outer sleeve assembly 80a. The threaded transmission member 62a and the push rod assembly 40a are connected by a threaded engagement. The threaded transmission member 62a only rotates. The rotation of the threaded transmission member 62a is converted into the axial movement of the push rod 42 through the threaded transmission between the threaded transmission member 62a and the push rod assembly 40a.

[0075] The threaded transmission component 62a includes a transmission screw 621 located at the distal end and a connecting rod 625 extending axially from the proximal end of the transmission screw 621. A stop ring 627 is radially provided on the outer wall of the proximal end of the transmission screw 621.

[0076] In the second embodiment, the base 44a of the push rod assembly 40a is based on the structure of the push rod assembly 40 in the first embodiment, and a screw hole 444 is provided. The transmission screw 621 is screwed into the screw hole 444.

[0077] The outer sleeve assembly 80a omits the connecting sleeve of the outer sleeve assembly 80 in the first embodiment. An annular flange 842 is provided on the inner wall of the sleeve 82 corresponding to the threaded drive member 62a. The proximal end of the threaded drive member 62a is rotatably inserted into the flange 842. A stop ring 627 is provided on the outer peripheral wall of the threaded drive member 62a at the distal end of the flange 842. A fixing ring 68 is fixedly connected to the proximal end of the threaded drive member 62a at the flange 842. The stop ring 627 and the fixing ring 68 form a rotating groove, and the flange 842 is rotatably received within the rotating groove. The distal end of the flexible outer tube 86 is fixedly connected to the proximal end of the sleeve 82. Because the stop ring 627 stops at the distal end face of the flange 842, and the fixing ring 68 stops at the proximal end face of the flange 842, the connecting rod 625 and the threaded drive member 62a can only rotate and cannot move axially.

[0078] In this embodiment, the connecting cylinder 84 is omitted and the transmission screw 621 of the threaded transmission component 62a is directly connected to the base 44a of the push rod assembly 40a through threaded engagement, which saves more space.

[0079] The use of the push-release type suture locking device in the second embodiment is similar to that in the first embodiment, except that the drive member on the rotating handle rotates, and the rotation of the drive member causes the flexible inner core and the threaded transmission member 62 to rotate in place, and the base 44a causes the push rod 42 to move relative to the clamp 22 to the far end.

[0080] The above are the embodiments of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the embodiments of the present invention, and these improvements and modifications are also considered to be within the protection scope of the present invention.

Claims

1. A pre-pushed release type suture locking device for fixing a suture in a locking peg, characterized in that, The device comprises a collet and a push rod assembly sleeved on the collet; the locking pin is accommodated in the distal end of the collet, and the collet itself is elastic; the push rod assembly comprises a push rod, and a recess is arranged on the side of the push rod facing the collet; during the continuous movement of the push rod along the axial direction towards the distal end, the push rod first pushes against the side of the protrusion gradually rising to force the collet to compress and deform the locking pin to lock the suture; then the protrusion is gradually accommodated in the recess, so that the collet at least partially recovers the deformation to release the locking pin.

2. The prepush release suture lock device of claim 1, wherein, The protrusion comprises a first outer inclined surface and a second outer inclined surface intersecting with the first outer inclined surface; the first outer inclined surface gradually rises from the proximal end to the distal end, and the second outer inclined surface gradually falls from the proximal end to the distal end.

3. The pre-push release suture lock device of claim 2, wherein, The included angle between the first outer inclined surface and the second outer inclined surface of the protrusion is greater than or equal to 120 degrees and less than 180 degrees.

4. The prepush release suture lock device of claim 3, wherein, The inclination of the first outer inclined surface is smaller than that of the second outer inclined surface; when the collet is in a natural state, the first included angle between the first outer inclined surface and a vertical surface perpendicular to the axial direction is greater than or equal to 70 degrees and less than 90 degrees, and the second included angle between the second outer inclined surface and the vertical surface perpendicular to the axial direction is greater than or equal to 50 degrees and less than 90 degrees.

5. The prepush release suture lock device of claim 2, wherein, The height difference between the distal end and the proximal end of the first outer inclined surface is greater than or equal to the inner hole diameter of the locking pin and less than the outer diameter of the locking pin.

6. The prepush release suture lock device of claim 2, wherein, The first outer inclined surface and the second outer inclined surface are smoothly transitioned; the distal end surface of the push rod and the surface of the push rod close to the collet are smoothly transitioned.

7. The pre-push release suture lock device of claim 2, wherein, The recess is arranged on the distal end of the push rod, and the recess comprises a first inner inclined surface and a second inner inclined surface intersecting with the first inner inclined surface; when the protrusion is accommodated in the recess, the first outer inclined surface corresponds to the first inner inclined surface, and the second outer inclined surface corresponds to the second inner inclined surface.

8. The pre-push release suture lock device of claim 7, wherein, The included angle between the first inner inclined surface and the second inner inclined surface of the recess is greater than or equal to the included angle between the first outer inclined surface and the second outer inclined surface of the protrusion.

9. The pre-push release suture lock device of claim 8, wherein, The included angle between the first inner inclined surface and a vertical surface perpendicular to the axial direction is greater than or equal to the included angle between the first outer inclined surface and the vertical surface perpendicular to the axial direction when the collet is in a natural state; the included angle between the second inner inclined surface and the vertical surface perpendicular to the axial direction is greater than or equal to the included angle between the second outer inclined surface and the vertical surface perpendicular to the axial direction when the collet is in a natural state.

10. The prepush release suture lock device of claim 7, wherein, The maximum depth of the recess is greater than or equal to the maximum height of the protrusion.

11. The pre-push release suture lock device of claim 7, wherein, The second inner inclined surface and the surface of the push rod close to the collet are smoothly transitioned.

12. The pre-push release suture lock device of claim 1, wherein, Further comprising a transmission assembly connected to the push rod assembly, the transmission assembly comprises a threaded transmission member and a flexible inner core fixedly connected to the threaded transmission member, and the threaded transmission member is rotationally connected to the push rod assembly; the rotation of the flexible inner core drives the rotation of the threaded transmission member, and the threaded transmission member drives the axial movement of the push rod.

13. The pre-push release suture lock device of claim 12, wherein, Further comprising a sleeve assembly surrounding the collet, push rod assembly and transmission assembly; the sleeve assembly comprises a sleeve and a flexible outer tube fixedly connected with the sleeve, the collet and the push rod assembly are contained in the sleeve, the collet is fixedly connected with the sleeve, and the flexible outer tube is sleeved outside the flexible inner core.

14. The pre-push release suture lock device of claim 13, wherein, The threaded transmission member is a transmission screw rod; a distal end of the threaded transmission member is rotationally connected with the push rod assembly through a connecting member; and the threaded transmission member is synchronously rotated and axially moved to drive the push rod to move axially.

15. The pre-push release suture lock device of claim 13, wherein, The threaded transmission member is a transmission screw rod; the threaded transmission member is directly screwed with the push rod assembly; and the threaded transmission member is only rotated to drive the push rod to move axially.

16. The prodding release suture lock device of any one of claims 12 to 15, wherein, Further comprising a driving member for driving the flexible inner core and the threaded transmission member to rotate, the driving member being fixedly connected with a proximal end of the flexible inner core.

17. The pre-push release suture lock device of claim 16, wherein, Further comprising a handle, the driving member being rotationally arranged at a proximal end of the handle.

18. The prodded release suture lock of claim 12, wherein, The push rod assembly further comprises a tangent blade arranged at an opposite side of the push rod.

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