CN113491547A

CN113491547A - Forward-pushing releasing type suture locking device

Info

Publication number: CN113491547A
Application number: CN202010205925.5A
Authority: CN
Inventors: 李阳; 梁伟林; 张庭超
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2020-03-20
Filing date: 2020-03-20
Publication date: 2021-10-12

Abstract

The invention provides a forward-push release type suture locking device which is used for fixing a suture in a locking nail and comprises a chuck and a push rod assembly sleeved outside the chuck; the locking nail is accommodated at the far end of the chuck, and the chuck has elasticity; the push rod assembly comprises a push rod, a concave part is arranged on one side of the push rod facing the chuck, and a convex part corresponding to the concave part is arranged on one side of the chuck facing the push rod; in the process that the push rod continuously moves towards the far end along the axial direction, the push rod firstly pushes one side of the bulge part which is gradually lifted so as to force the chuck to press the locking nail to deform and lock the suture line; and then the convex part is gradually accommodated in the concave part, so that the chuck at least restores partial deformation to release the locking nail. The forward-push release type suture line locking device can avoid instantaneous violent jumping of the clamping head releasing locking nail, and greatly reduces the risk of tearing the tissue.

Description

Forward-pushing releasing type suture locking device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a forward-pushing release type suture locking device.

Background

The operation of knotting and fixing suture is often required in the operation, and the traditional surgical operation is operated under the condition of open vision, and the knotting is usually carried out manually by a doctor. However, with advances in technology, various minimally invasive and interventional procedures are becoming more common, such as laparoscopic procedures, transcatheter interventional procedures, and the like. These procedures require only a small operating window to be cut into the patient's body, whereby an instrument such as an endoscope or interventional catheter is inserted into the patient's body to a predetermined site for treatment. In such procedures, if knotting or fixing of the suture in the patient is required, the operator is usually required to perform operations outside the patient through the small operation window to knot or fix the suture in the patient, which requires the suture locking device.

The existing suture locking device comprises a locking nail with a hollow inner cavity, a chuck which is matched with the locking nail and applies pressure to the locking nail to force the locking nail to deform, and a push rod which is connected with the chuck and provides driving force for the chuck, wherein a suture is arranged in the hollow inner cavity of the locking nail in a penetrating mode, the chuck is driven to carry out profiling on the locking nail by pushing the push rod forwards towards the far end of the chuck along the axial direction to lock the suture, and the push rod is pulled backwards along the opposite direction of the axial direction after the profiling of the locking nail is finished, so that the push rod is gradually far away from the chuck to release the force applied to the chuck by the push rod, and the chuck releases the locking nail. As shown in fig. 1, the direction of the force when the push rod is driven to press the locking nail by the chuck is opposite to the direction of the force when the locking nail is released, the stress curve of the push rod has forward and reverse cliff type jumps, and the stress condition of the chuck also has cliff type jumps; at the moment when the push rod is pulled to withdraw and the chuck releases the locking nail, the push rod can drive the chuck and the locking nail to violently tear the sutured tissue, and the tissue has high risk of tearing.

Disclosure of Invention

The invention aims to provide a forward-pushing releasing type suture locking device aiming at the defects of the prior art, which can avoid instantaneous violent jumping of a chuck releasing lock nail and greatly reduce the risk of tearing tissues.

In order to solve the technical problem, the invention provides a forward-pushing releasing type suture locking device which comprises a chuck and a push rod assembly sleeved outside the chuck; the push rod assembly comprises a push rod, a concave part is arranged on one side of the push rod facing the chuck, and a convex part corresponding to the concave part is arranged on one side of the chuck facing the push rod; the clamping head has elasticity, and a locking nail with a suture line is arranged in the clamping head in a penetrating mode; in the process that the push rod continuously moves towards the far end along the axial direction, the push rod firstly pushes one side of the bulge part which is gradually lifted so as to force the chuck to press the locking nail to deform and lock the suture line; and then the convex part is gradually accommodated in the concave part, so that the chuck at least restores partial deformation to release the locking nail.

The application provides a push away release type suture locking device before, sets up the depressed part on the chuck, sets up the bellying on the push rod, is pushing towards the distal end along the axial continuously the in-process of push rod, the push rod supports earlier and pushes away the one side that the bellying of chuck risees gradually to force the chuck oppression pintle to warp and lock the suture line of wearing to locate in the pintle, then the bellying holds gradually in the depressed part, the chuck recovers partial deformation at least in order to release the pintle, carries out the die mould and the release of pintle through promoting the push rod continuously promptly, and the continuity of push rod and chuck atress has been guaranteed in whole promotion, can avoid chuck release pintle violent jump in the twinkling of an eye, prevents chuck and pintle and tears the tissue of being sewed up widely, thereby reduces the tissue by torn risk by a wide margin.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

Fig. 1 is a schematic diagram showing the relationship between the force and the stroke of a push rod in the process of pressing and locking a nail and releasing the nail of a lower chuck in the prior art.

FIG. 2 is a schematic perspective view of a push-to-release suture locking device according to a first embodiment of the present invention.

Fig. 3 is a sectional view taken along line III-III in fig. 2.

Fig. 4 is an enlarged view of the portion IV in fig. 3.

FIG. 5 is a schematic perspective view of a staple compressed by a collet of a push-to-release suture locking device according to a first embodiment of the present invention.

Fig. 6 is a cross-sectional view of the locking pin of fig. 5.

Fig. 7 is a cross-sectional view of the staple of fig. 5 after profiling.

Fig. 8 is a cross-sectional structural view of the cartridge of fig. 4.

Fig. 9 is a schematic view of a deformed state of the collet of fig. 8.

Fig. 10 is a perspective view of the push rod assembly of fig. 4.

Fig. 11 is a cross-sectional structural schematic view of the push rod assembly of fig. 10.

Fig. 12 is a cross-sectional view of the push rod assembly and transmission assembly of fig. 2.

Figure 13 is a cross-sectional view of the chuck, push rod assembly, transmission assembly and driver of figure 2.

FIG. 14 is an enlarged view of the chuck, pushrod assembly and portion of the drive assembly of FIG. 13.

Fig. 15 is a perspective view of the handle and outer support tube assembly of fig. 2.

Figure 16 is a cross-sectional view of a portion of the handle and outer support tube assembly of figure 15.

Figures 17-19 are schematic illustrations of the first embodiment of the present invention providing an advancement-release suture locking device for use in a valve repair procedure for a diseased tricuspid valve.

Fig. 20 is an enlarged view of the portion XX in fig. 19.

FIGS. 21-23 are schematic illustrations of the process of securing a suture within a staple by a push-to-release suture locking device provided in accordance with a first embodiment of the present invention.

FIG. 24 is a schematic view showing the relationship between the force and the stroke of the push rod during the process of the chuck press type locking pin and the process of releasing the locking pin.

FIG. 25 is a schematic structural view of a push-to-release suture locking device according to a second embodiment of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without any inventive step, are within the scope of the present invention.

Furthermore, the following description of the various embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. Directional phrases used in this disclosure, such as, for example, "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and the like, refer only to the orientation of the appended drawings and are, therefore, used herein for better and clearer illustration and understanding of the invention, and do not indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in a particular orientation, and are therefore not to be considered limiting of the invention.

Orientation definition: for clarity of description, the end of the instrument closer to the operator during the procedure will be referred to hereinafter as the "proximal end" and the end further from the operator as the "distal end"; the axial direction is parallel to the direction of the connection line of the center of the far end and the center of the near end of the medical instrument; the foregoing definitions are for convenience only and are not to be construed as limiting the present invention.

Referring to fig. 2-4, a first embodiment of the invention provides a push-to-release suture locking device 100 for locking a suture to a staple 300. The forward-push release type suture locking device 100 comprises a chuck 22 arranged at the far end for pressing a locking nail 300 to deform, a push rod assembly 40 sleeved outside the chuck 22 for controlling the chuck 22 to open and close, a transmission assembly 60 connected to the push rod assembly 40, a driving member 70, a supporting tube assembly 80 surrounding the chuck 22, the push rod assembly 40 and the transmission assembly 60, and a handle 90 arranged at the near end. The distal end of the cartridge 22 is provided with a space 25 (see fig. 8) for placing a locking nail 300, and the locking nail 300 is provided with a threading cavity 301 along the axial direction, and the threading cavity 301 is used for threading a suture. The push rod assembly 40 comprises a push rod 42 arranged outside the chuck 22, a concave part 420 is arranged on one side of the push rod 42 facing the chuck 22, the chuck 22 is fixed in axial position and elastic, and a convex part 220 corresponding to the concave part 420 is arranged on one side of the chuck 22 facing the push rod 42; the transmission assembly 60 comprises a screw transmission member 62 and a flexible inner core 63 fixedly connected with the screw transmission member 62 and having a certain axial length, and the distal end of the screw transmission member 62 is rotatably connected with the push rod assembly 40; the flexible inner core 63 rotates to drive the screw transmission member 62 to rotate, and the rotation of the screw transmission member 62 drives the push rod assembly 40 to move axially and distally, so that the push rod 42 moves axially and distally to push against the gradually rising side of the protruding portion 220 of the collet 22, thereby forcing the collet 22 to press the locking nail 300 to deform and lock the suture thread passing through the locking nail 300; the flexible inner core 63 continues to rotate in the same direction to drive the screw transmission member 62 to rotate, and the rotation of the screw transmission member 62 drives the push rod assembly 40 and the push rod 42 to continue to move axially and distally until the protrusion 220 of the collet 22 is gradually accommodated in the recess 420, so that the collet 22 at least partially deforms again to release the locking pin 300.

In the process of continuously pushing the push rod 42 in the axial direction toward the distal end, the push rod 42 first pushes against the gradually rising side of the protruding portion 220 of the collet 22 to force the collet 22 to press the locking nail 300 to deform and lock the suture thread passing through the locking nail 300, then the protruding portion 220 on the collet 22 is gradually accommodated in the recessed portion 420 of the push rod 42, the collet 22 recovers at least part of the deformation to release the locking nail 300, that is, the compression and release of the locking nail 300 are implemented by continuously pushing the push rod 42, the whole pushing process ensures the continuity of the stress of the push rod 42 and the collet 22 (as shown in fig. 24), can avoid the instant jump of the collet 22 releasing the locking nail 300, and prevent the collet 22 and the locking nail 300 from tearing the sutured tissue, such as valve leaflets, so as to greatly reduce the risk of the tissue being torn.

Further, the push rod 42 is pushed to the far end along the axial direction to push against the gradually rising side of the convex portion 220 of the chuck 22, the resistance is gradually increased in the process of profiling the lock pin 300, and the driving force required by the push rod 42 is correspondingly gradually increased; after the push rod 42 continues to be pushed distally along the axial direction to cross the highest point of the convex portion 220, the convex portion 220 is gradually accommodated in the concave portion 420, the resistance is gradually reduced, and the driving force required by the push rod 42 is correspondingly gradually reduced; therefore, the operator can know whether the lock pin 300 is pressed and whether the suture is locked or not by sensing the operation hand feeling.

On the other hand, the forward-pushing releasing type suture locking device 100 converts the rotation torque of the flexible inner core 63 and the screw transmission member 62 into an axial thrust force of the screw transmission member 62 driving the push rod 42 to move axially to drive the push rod 42 to push towards the far end along the axial direction, and since the screw transmission member 62 is rigid and short in length, the thrust force loss is very small, the thrust force can be smoothly and effectively transmitted to the push rod 42 to push against the chuck 22, so that the chuck 22 can effectively press the locking nail 300 to enable the locking nail 300 to deform sufficiently, and the suture line is ensured to be reliably locked by the locking nail 300.

As shown in fig. 3 and 4, the outer support tube assembly 80 includes a sleeve 82 for receiving the collet 22 and the push rod assembly 40, an end cap 88 secured to a distal end of the sleeve 82, a connector barrel 84 secured to a proximal end of the sleeve 82, and a flexible outer tube 86 secured to a proximal end of the connector barrel 84. The threaded driving member 62 is rotatably connected to the outer sleeve member 80, and the threaded driving member 62 rotates relative to the outer sleeve member 80 to move the push rod 42 in the axial direction. The collet 22 and the push rod assembly 40 are disposed in the sleeve 82, the collet 22 is fixedly coupled to the sleeve 82 such that the axial position of the collet 22 is fixed, and the flexible outer tube 86 is disposed over the flexible inner core 63. The screw drive member 62 is rotatably connected within the connector barrel 84, and in particular, the screw drive member 62 is in threaded engagement with the connector barrel 84. In this embodiment, the screw transmission member 62 is a transmission screw, a connection portion 67 is disposed at a distal end of the screw transmission member 62, the connection portion 67 is rotatably connected to the push rod assembly 40, and the screw transmission member 62 synchronously rotates and axially moves to drive the push rod assembly 40 to axially move.

As shown in FIG. 4, the distal end of the flexible outer tube 86 is fixedly connected to the proximal end of the connector barrel 84, the connector barrel 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 lumen of the flexible outer tube 86 communicates with the lumen of the connector barrel 84, and the connector barrel 84 is threadedly connected to the threaded drive member 62. The flexible outer tube 86 is a tube body having a certain supporting force, and preferably a laser-cut outer tube, a spiral structure, a braided mesh structure, or the like. In this embodiment, the flexible outer tube 86 is laser cut. The flexible outer tube 86 may be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, etc., and in this embodiment, the flexible outer tube 86 is made of nickel-titanium alloy.

The sleeve 82 is a hollow tube, the proximal end of the sleeve 82 is snapped onto the distal end of the connector barrel 84, and the distal end of the sleeve 82 is snapped onto the end cap 88. The threading slot 820 is formed in the peripheral wall of the sleeve 82 near the collet 22, and the threading slot 820 is used for the threading of the suture thread passing through the locking nail 300. The distal end of the end cap 88 defines a suture inlet 880 communicating with the lumen of the sleeve 82, and the locking pin 300 is inserted into the lumen of the sleeve 82 through the suture inlet 880.

Referring to fig. 5 and 6, the locking pin 300 includes a locking cylinder 302 and a circular truncated cone 303 disposed at a distal end of the locking cylinder 302. The outer diameter of the circular truncated cone 303 of the locking pin 300 is larger than the outer diameter of the locking cylinder 302. Threading lumen 301 of locking nail 300 is axially disposed through opposing ends of locking nail 300, threading lumen 301 being adapted to receive and pass a suture. The locking barrel 302 may be collapsed upon application of a mechanical force to secure the suture in the threading lumen 301 of the locking pin 300. The locking pin 300 may be of various shapes, e.g., cylindrical, prismatic, oval, etc., so long as it has a threaded cavity 301 for receiving a suture. The distal opening of the threading lumen 301 of the locking nail 300 smoothly transitions with the distal surface of the locking nail 300 to avoid the junction therebetween cutting the suture or scratching the internal tissue of the patient. The locking pin 300 is made of a biocompatible material such as stainless steel, pure titanium, nickel titanium, cobalt chromium alloy, and preferably pure titanium or stainless steel.

In this embodiment, as shown in fig. 6, when the locking pin 300 is not compressed by an external force, the initial height h1 of the middle portion of the locking pin 300 is equal to the outer diameter of the lock barrel 302 of the locking pin 300; as shown in fig. 6, when the lock cylinder 302 of the lock pin 300 is collapsed by mechanical external force, the suture is fixed in the threading cavity 301 of the lock pin 300, and the collapsed height h2 of the lock pin 300 is smaller than the initial height h 1.

In order to improve the coupling force between the crimped lock pin 300 and the suture, an anti-slip structure may be further provided on the inner circumferential surface of the threading cavity 301, for example, an anti-slip pattern or a roughening treatment may be provided on the inner circumferential surface of the threading cavity 301, so that after the lock pin 300 is deformed by external crimping force, the friction force between the suture and the inner circumferential surface of the threading cavity 301 is increased, and the suture is more firmly fixed in the threading cavity 301 of the lock pin 300.

Referring to fig. 8 and 9, the chuck 22 includes a first chuck 221 and a second chuck 223 formed integrally and disposed oppositely, and the protrusion 220 is disposed on a side of the first chuck 221 away from the second chuck 223. The gap 25 is formed between the first and

second collets

221 and 223. When the driving member 70 drives the screw transmission member 62 to rotate, because the position of the connecting cylinder 84 is fixed, the screw transmission member 62 rotates and moves axially to push the push rod 42 to move axially, i.e. the rotation of the screw transmission member 62 is converted into the axial movement of the push rod 42, so that the push rod 42 slidably pushes against the protrusion 200 of the collet member 22 to drive the first collet 221 and the second collet 223 to move toward each other and press the locking nail 300, so that the locking nail 300 deforms and is fixed to the suture.

In this embodiment, the first chuck 221 and the second chuck 223 are integrally formed by an elastic hard material, the proximal end of the chuck 22 is closed, a pin 24 perpendicular to the axial direction penetrates through the proximal end of the chuck 22, and opposite ends of the pin 24 are respectively fixed to the sleeves 82. The pin 24 positions the cartridge 22 and prevents the cartridge 22 from moving axially. The physical location of the proximal ends of the first and

second collets

221, 223 provides support and power for the first collet 221 to rebound.

In this embodiment, the protruding portion 220 is located at a distal end of a side of the first collet 221 facing away from the second collet 223, the protruding portion 220 includes a first outer inclined surface 2201 and a second outer inclined surface 2203 intersecting with each other, the first outer inclined surface 2201 and the second outer inclined surface 2203 intersect with each other at a side of the first collet 221 facing away from the second collet 223, the first outer inclined surface 2201 gradually increases from a proximal end to a distal end thereof, and the second outer inclined surface 2203 gradually decreases from the proximal end to the distal end thereof. As shown in fig. 4 and fig. 9, the first outer inclined surface 2201 corresponds to the side of the protrusion 220 that gradually rises, and the distal end of the push rod 42 axially slidably pushes the first outer inclined surface 2201 to press the first collet 221 gradually to close to the second collet 223, so as to press the locking pin 300. Pushing the push rod 42 distally continues until the protrusion 220 is gradually received in the recess 420, the collets 22 rebound, the first collet 221 is away from the second collet 223, and the gap between the first and

second collets

221 and 223 increases to a height h2 greater than the collapsed height of the locking pin 300 to release the locking pin 300. Further, the side of the distal end of the first clamping head 221 facing the gap 25 is provided with a first clamping tooth 2215, and the first clamping tooth 2215 comprises a plurality of tooth slots, each tooth slot extending in a direction substantially perpendicular to the axial direction.

As shown in fig. 8, the first outer slope 2201 is located at the proximal end of the protruding portion 220, and the first outer slope 2201 gradually extends from the proximal end to the distal end thereof to a side away from the second collet 223; the second outer slope 2203 is located at the distal end of the protruding portion 220, and the second outer slope 2203 gradually extends from the proximal end to the distal end toward the side near the second collet 223. An included angle a is formed between the first outer inclined surface 2201 and the second outer inclined surface 2203 of the boss 220, and preferably, a is more than or equal to 120 degrees and less than 180 degrees. Further, when the collet 22 is in the initial state (or referred to as the natural state, which means the state before the collet 22 is pushed by the push rod 42), the angle range of the first included angle a1 between the first outer inclined surface 2201 and the vertical plane L perpendicular to the axial direction is 70 ° ≦ a1 < 90 °, the angle range of the second included angle a2 between the second outer inclined surface 2203 and the vertical plane L perpendicular to the axial direction is 50 ° ≦ a2 < 90 °, and the sum of the first included angle a1 and the second included angle a2 is equal to the included angle a between the first outer inclined surface 2201 and the second outer inclined surface 2203. It is noted that a2 < a1, or the slope of the first outer slope 2201 is smaller than the slope of the second outer slope 2203, and the slope of the first outer slope 2201 is more gradual, which helps to reduce the driving force for pushing the push rod 42 to push the push rod 42 against and press the collet 22, allowing the collet 22 to deform gradually.

As shown in fig. 8, the height difference H1 between the distal end and the proximal end of the first outer inclined surface 2201 is greater than or equal to the diameter of the inner hole, i.e., the threading cavity 301, of the locking barrel 302 of the locking nail 300 and smaller than the outer diameter of the locking barrel 302 of the locking nail 300, so that when the push rod 42 pushes against the distal end of the first outer inclined surface 2201, the first clamping head 221 and the second clamping head 223 can sufficiently press the locking nail 300 to lock the suture thread passing through the locking nail 300.

Referring to fig. 8 and 9, the height difference H between the highest point of the protruding portion 220 before the first clamping head 221 is deformed and after the deformation resilience is finished is smaller than the difference between the initial height H1 and the height H2 after the nail 300 is compressed. Specifically, the vertical length between the highest point of the protruding portion 220 before the first collet 221 deforms and the axial plane passing through the axis of the pin 24 is H2 (as shown in fig. 8), the vertical length between the highest point of the protruding portion 220 and the axial plane passing through the axis of the pin 24 is H3 (as shown in fig. 9) after the first collet 221 is pressed and rebounded, the height difference H is obtained by subtracting H3 from H2, and the height difference H is smaller than the difference between the initial height H1 before the compression of the locking pin 300 and the height H2 after the compression of the locking pin 300, so that the locking pin 300 can be smoothly taken out of the gap 25 of the collet 22; when the difference H is 0, the first collet 221 is completely restored to the initial state.

The arc transition at the intersection of the first outer inclined surface 2201 and the second outer inclined surface 2203 facilitates the push rod 42 to smoothly pass through the intersection of the first outer inclined surface 2201 and the second outer inclined surface 2203, i.e., the push rod 42 smoothly slides from the first outer inclined surface 2201 to the second outer inclined surface 2203.

The side of the second jaw 223 facing the first jaw 221 adjacent the distal end is provided with second clamping teeth 2235, the second clamping teeth 2235 including a plurality of gullets, each gullet of the second clamping teeth 2235 extending in the same direction as the gullet of the first clamping teeth 2215. When the first cartridge 221 and the second cartridge 223 are moved toward each other along the pin 24, the first teeth 2215 of the first cartridge 221 and the second teeth 2235 of the second cartridge 223 are misaligned and engaged with each other, so that the first cartridge 221 is elastically deformed toward the second cartridge 223, and the first teeth 2215 and the second teeth 2235 press the locking pin 300 placed in the gap 25 into a shape having a curvature. The proximal end of the side of the second clamping head 223 facing away from the first clamping head 221 is provided with a horizontal sliding guide surface 2236, and the sliding guide surface 2236 is provided with a threading hole 2237 communicating with the gap 25, so that a suture thread passing through the locking nail 300 can conveniently pass through the threading hole 2237. A positioning block 2233 is convexly arranged at the far end of the side surface of the second chuck 223 departing from the first chuck 221, the near end surface of the positioning block 2233 is close to the threading hole 2237, and the near end surface of the positioning block 2233 is a tangential surface 2238.

Referring to fig. 4 and 10-11, the push rod assembly 40 further includes a base 44 movably disposed in the sleeve 82 along the axial direction and a cutting blade 46 fixedly connected to one side of the base 44, a proximal end of the push rod 42 is fixedly connected to the other side of the base 44 opposite to the cutting blade 46, and the push rod 42 extends to the distal end along the axial direction. The connecting portion 67 is rotatably connected with the base 44, and an axial limiting structure is arranged between the connecting portion 67 and the base 44. The cutting blade 46 is disposed opposite to the push rod 42 at a distance, and the cutting blade 46 slides on the slide guide surface 2236 in the axial direction.

The recess 420 is disposed on a side of the push rod 42 proximate to the first jaw 221 and near a distal end of the push rod 42. Recess 420 includes intersecting first interior slope 4201 and second interior slope 4203, first interior slope 4201 being further from the distal face of pushrod 42 than second interior slope 4203. When the protruding portion 220 is received in the recessed portion 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.

As shown in fig. 11, the first inner inclined surface 4201 gradually extends from the proximal end to the distal end to a side away from the first collet 221, and the second inner inclined surface 4203 gradually extends from the proximal end to the distal end to a side close to the first collet 221. The distal edge of the second outer bevel 4203 is radiused such that the pushrod 42 slides smoothly against the second outer bevel 2203; the distal end surface of push rod 42 transitions in a circular arc with the surface of push rod 42 proximate collet 22 such that push rod 42 slides smoothly against first outer ramp 2201.

An included angle b between the first inner inclined surface 4201 and the second inner inclined surface 4203 of the concave portion 420 is greater than or equal to an included angle a between the first outer inclined surface 2201 and the second outer inclined surface 2203 of the convex portion 220, so that the convex portion 220 is accommodated in the concave portion 420. Preferably, a third included angle b1 between the first inner inclined surface 4201 and the vertical plane O perpendicular to the axial direction is greater than or equal to the first included angle a1, and a fourth included angle b2 between the second inner inclined surface 4203 and the vertical plane O perpendicular to the axial direction is greater than or equal to the second included angle a 2; the sum of the third angle b1 and the fourth angle b2 is equal to the angle b between the first interior slope 4201 and the second interior slope 4203.

As shown in fig. 11, the maximum depth H4 of the concave portion 420 is the vertical length from the highest point of the concave portion 420 to the surface of the push rod 42 adjacent to the cartridge 22, and the maximum depth H4 is greater than or equal to the height difference H1 between the distal end and the proximal end of the first outer inclined surface 2201, or the maximum height of the convex portion 220, so as to ensure that the convex portion 220 can be completely accommodated in the concave portion 420, and provide sufficient rebound space for the cartridge 22; when the raised portion 220 is received in the recessed portion 420, the height of the void 25 is greater than the height h2 of the pin 300 after it has been collapsed to facilitate release of the pin 300.

The cutting blade 46 has a cutting edge 461 at a distal end thereof, and when the protrusion portion 220 is completely received in the recess portion 420, the cutting edge 461 abuts against the cutting surface 2238 to cut the suture thread passing through the threading hole 2237.

It is understood that in other embodiments, the shape of the protruding portion 220 may also be a protrusion in the shape of a hemisphere, a truncated cone, a cone, etc., and the shape of the recessed portion 420 may also be a groove or a void in the shape of a hemisphere, a truncated cone, a cone, etc. that is adapted to the protruding portion 220.

Referring to fig. 3, 4 and 12-14, the flexible inner core 63 includes a flexible inner tube 64 connected to the proximal end of the screw drive 62 and a stem 66 inserted into the inner cavity of the flexible inner tube 64, and the connecting portion 67 is connected between the distal end of the screw drive 62 and the base 44 of the push rod assembly 40. A flexible inner tube 64 is wrapped around a core rod 66, the flexible inner tube 64 and the core rod 66 together forming a flexible inner core 63. The screw driver 62 includes a driving screw 621, and the driving screw 621 is screwed to 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, the proximal end of the flexible inner tube 64 is fixedly connected to the driving member 70, and the driving member 70 is used for driving the flexible inner core 63 and the threaded transmission member 62 to rotate. The flexible inner tube 64 is a tube body with a certain supporting force, preferably a tube body with a spiral structure or a braided net structure, and can be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy and other materials. The outer diameter of the flexible inner tube 64 is smaller than the inner diameter of the flexible outer tube 86. Rotation of the flexible inner tube 64 relative to the connector barrel 84 rotates and moves the screw drive 62 axially.

The core rod 66 is inserted into the inner cavity of the flexible inner tube 64, the core rod 66 is a core rod with certain flexibility, and preferably, the core rod 66 may be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, and the like. The provision of the core rod 66 facilitates the winding of the wire thereon to form the flexible inner tube 64 and enhances the twist control of the flexible inner core 63.

The driving screw 621 rotates and moves axially to drive the connecting portion 67 to rotate relative to the base 44, and meanwhile, the distal end of the driving screw 621 pushes the base 44, the push rod 42 and the cutting blade 46 to move axially toward the distal end.

In other embodiments, the connecting portion 67 may also be fixedly connected to the push rod assembly 40, the connecting portion 67 is rotatably connected to the screw transmission member 62, and a limiting structure is disposed between the connecting portion 67 and the screw transmission member 62 to prevent the connecting portion 67 from moving axially relative to the screw transmission member 62, so that the connecting portion 67 is rotatably connected to the screw transmission member 62.

As shown in fig. 3 and 13, the driving member 70 is connected to the proximal end of the transmission assembly 60, specifically, the driving member 70 is a rotating member rotatably disposed at the proximal end of the handle 90, and the proximal ends of the flexible inner tube 64 and the core rod 66 are fixedly connected to the driving member 70. Rotation of the driving member 70 causes the flexible inner tube 64 and the core pin 66 to rotate together. The outer wall of the driving member 70 is provided with an anti-slip mechanism 79, and the driving member 70 can be conveniently rotated by holding the anti-slip mechanism 79 by hand.

Referring to fig. 2, fig. 3, fig. 15 and fig. 16, the driving member 70 is rotatably connected to the proximal end of the handle 90, at least one length scale 915 is axially disposed on the handle 90 adjacent to the driving member 70, and the at least one length scale 915 is used for displaying the displacement amount of the driving member 70 moving axially. When the distal surface of driver 70 is aligned with 0 on length scale 915, first and

second collets

221 and 223 of collet 22 are in a fully expanded state, and push rod 42 does not apply an axial pushing force to collet 22; when the driving member 70 rotates and moves axially until the distal end surface of the driving member is aligned with a certain scale value such as "6" on the length scale 915, the push rod 42 pushes against the highest point of the protrusion 220 of the collet 22, and the first collet 221 and the second collet 223 press the locking nail 300 to deform and fix the suture thread passing through the locking nail 300; as the driver 70 continues to rotate in the same direction and moves axially until its distal surface is aligned with another scale value on the length scale 915, such as "7.5", the protrusions 220 on the collet 22 are received in the recesses 420 of the push rod 42 and the first collet 221 portion of the collet 22 resiliently returns away from the second collet 223 to facilitate release of the locking pin 300.

Referring to fig. 17-23, the use of the push-to-release suture locking device 100 of the present invention is described below, using a tricuspid valve repair procedure as an example.

The tricuspid valve is a one-way "valve" between the Right Atrium (RA) and the Right Ventricle (RV), which ensures blood flow from the right atrium to the right ventricle. A normal healthy tricuspid valve has a plurality of chordae tendineae. The valve leaves of the tricuspid valve are divided into an anterior leaf, a posterior leaf and a septal lobe, when the right ventricle is in a diastole state, the three are in an open state, and blood flows from the right atrium to the right ventricle; when the right ventricle is in a contraction state, the chordae tendineae are stretched to ensure that the valve leaflets are not flushed to the atrium side by blood flow, and the anterior leaflet, the posterior leaflet and the septal leaflet are well closed, thereby ensuring that blood flows from the right ventricle to the pulmonary artery through the Pulmonary Valve (PV). If the tricuspid valve is diseased, when the right ventricle is in a contracted state, the tricuspid valve cannot be restored to a completely closed state as in a normal state, but an incomplete closing phenomenon occurs, and the impulse of blood flow further causes the valve leaflets to fall into the right atrium, so that blood backflow is caused. For tricuspid valve regurgitation, a suture can be implanted into each leaflet in an interventional mode, and then the suture on each leaflet is locked together by using the locking and knotting device in the invention so as to implement edge-to-edge repair, which comprises the following specific processes:

the first step is as follows: as shown in fig. 17, firstly, one or more sutures 500 with elastic pads 501 are respectively implanted into the anterior leaflet, the posterior leaflet and the septal leaflet of the tricuspid valve of a patient, and the point contact between the sutures 500 and the leaflets is converted into the surface contact between the elastic pads 501 and the leaflets, so that the risk of tearing the leaflets can be effectively reduced;

the second step is that: as shown in fig. 17 and 21, a plurality of sutures 500 on three leaflets are all threaded into the threading cavity 301 of the locking nail 300 of the forward-release-type suture locking device 100 outside the patient, and the proximal ends of the sutures 500 are sequentially threaded through the threading cavity 301 of the locking nail 300, the gap 25 between the first clamping head 221 and the second clamping head 223 and the threading hole 2237 and then are threaded out of the threading groove 820 of the sleeve 82;

the third step: pushing the distal end of the forward-push release suture locking device 100 into the right atrium of the heart through the femoral vein by means of a bending sheath (not shown), moving closer to the leaflets of the tricuspid valve while pulling the suture 500 until the distal end of the forward-push release suture locking device 100 reaches a predetermined position in the right atrium;

the fourth step: adjusting the tightness of the three leaflet sutures 500 of the anterior, posterior and septal leaflets, respectively, while determining the state of the tricuspid valve with the lightest regurgitation by ultrasound, and when this state is reached, stopping adjusting and maintaining the tightness of the three sets of sutures 500, i.e. maintaining the relative positions between the anterior, posterior and septal leaflets of the tricuspid valve;

the fifth step: as shown in fig. 18 and 22, when the driving member 70 on the handle 90 is rotated, the screw transmission member 62 moves axially and distally at the same time, and drives the driving member 70, the flexible inner core 63, and the screw transmission member 62 to move axially and distally along the rotating edge, the screw transmission member 62 pushes the push rod assembly 40 to move axially and distally, during the axial distal movement of the push rod assembly 40, the push rod 42 moves distally relative to the collet 22, the distal end of the push rod 42 continuously pushes and presses the first outer inclined surface 2201 on the first collet 221 until reaching the highest point of the protrusion 220, so that the first collet 221 approaches the second collet 223, and the first gripping tooth 2215 and the second gripping tooth 2235 press and grip the locking nail 300 accommodated in the gap 25 until the locking nail 300 deforms, and the three groups of sutures 500 in the locking nail 300 are locked together.

And a sixth step: as shown in fig. 19, 20 and 23, by further rotating the driving member 70 on the handle 90 in the same rotational direction, the screw drive 62 continues to move axially and distally to drive the push rod 42 to move distally until the protrusions 220 on the first jaw 221 enter the recesses 420 of the push rod 42, the jaw 22 releases the staple 300, the cutting blade 46 cuts the suture 500, and the staple 300 is released from the gap 25 of the jaw 22; then the redundant suture thread 500 is drawn out of the body of the patient through the locking path;

the seventh step: the distal end of the knotting device 100 is withdrawn from the patient and the locking pin 300 remains in the patient, at which point the locking pin 300 secures together the three sets of sutures that pass through the anterior, posterior and septal leaflets, respectively, and the anterior, posterior and septal leaflets of the tricuspid valve are repaired.

It should be understood that the above description is provided only by way of example of the use of a push-to-release suture locking device for interventional tricuspid valve repair procedures, and that the push-to-release suture locking device of the present invention may be used for locking and securing sutures in other surgical procedures.

Referring to FIG. 25, a second embodiment of the invention provides a push-to-release suture locking device having a similar structure to the first embodiment, except that: the structure of the push rod assembly 40a and the screw transmission member 62a in the second embodiment is slightly different from that in the first embodiment, and the connection structure of the push rod assembly 40a and the screw transmission member 62a is slightly different from that in the first embodiment, as follows:

the thread locking device of the forward-push release type in the second embodiment also includes a chuck 22, a push rod assembly 40a, a transmission assembly and an outer casing assembly 80a, wherein the screw transmission member 62a is rotatably connected to the outer casing assembly 80a, the screw transmission member 62a and the push rod assembly 40a are in screw-fit transmission, the screw transmission member 62a only rotates, and the rotation of the screw transmission member 62a is converted into the axial movement of the push rod 42 through the screw transmission between the screw transmission member 62a and the push rod assembly 40 a.

The screw driving element 62a includes a driving screw 621 at a distal end and a connecting rod 625 extending axially from a proximal end of the driving screw 621, and a stop ring 627 is radially disposed on an outer wall of the proximal end of the driving screw 621.

The base 44a of the push rod assembly 40a in the second embodiment is provided with a screw hole 444 on the basis of the structure of the push rod assembly 40 in the first embodiment, and the transmission screw 621 is screwed with the screw hole 444.

The outer sleeve component 80a omits a connecting cylinder of the outer sleeve component 80 in the first embodiment, an annular flange 842 is arranged on the inner wall of the sleeve 82 corresponding to the screw driver 62a, the proximal end of the screw driver 62a is rotatably inserted into the flange 842, a stop ring 627 is arranged on the outer peripheral wall of the screw driver 62a at the distal end of the flange 842, the screw driver 62a is fixedly connected with a fixing ring 68 at the proximal end of the flange 842, a rotating groove is defined by the stop ring 627 and the fixing ring 68, the flange 842 is rotatably accommodated in the rotating groove, and the distal end of the flexible outer tube 86 is fixedly connected with the proximal end of the sleeve 82. Since the stop ring 627 is stopped at the distal end surface of the flange 842 and the fixing ring 68 is stopped at the proximal end surface of the flange 842, the connecting rod 625 and the screw drive 62a can only be rotated and cannot be moved axially.

In this embodiment, the connecting tube 84 is omitted and the driving screw 621 of the screw driving element 62a directly drives the base 44a of the push rod assembly 40a through screw-fitting, thereby saving more space.

The use of the push-to-release suture locking device of the second embodiment is similar to the first embodiment except that the drive member on the handle is rotated, rotation of the drive member rotates the flexible core and screw drive 62 in place and the base 44a moves the push rod 42 distally relative to the collet 22.

The foregoing is illustrative of embodiments of the present invention, and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the embodiments of the present invention and are intended to be within the scope of the present invention.

Claims

1. A forward-push release type suture locking device is used for fixing a suture in a locking nail and is characterized by comprising a chuck and a push rod assembly sleeved outside the chuck; the locking nail is accommodated at the far end of the chuck, and the chuck has elasticity; the push rod assembly comprises a push rod, a concave part is arranged on one side of the push rod facing the chuck, and a convex part corresponding to the concave part is arranged on one side of the chuck facing the push rod; in the process that the push rod continuously moves towards the far end along the axial direction, the push rod firstly pushes one side of the bulge part which is gradually lifted so as to force the chuck to press the locking nail to deform and lock the suture line; and then the convex part is gradually accommodated in the concave part, so that the chuck at least restores partial deformation to release the locking nail.

2. The push-to-release suture locking device of claim 1, wherein the boss comprises a first outer ramp and a second outer ramp intersecting the first outer ramp; the first outer slope is gradually increased from the proximal end to the distal end, and the second outer slope is gradually decreased from the proximal end to the distal end.

3. The push-to-release suture locking device of claim 2, wherein the angle between the first outer slope and the second outer slope of the protrusion is in a range of 120 degrees or more and less than 180 degrees.

4. The push-to-release suture locking device of claim 3, wherein the slope of the first outer slope is less than the slope of the second outer slope; when the chuck is in a natural state, the angle range of a first included angle between the first outer inclined plane and the vertical plane perpendicular to the axial direction is more than or equal to 70 degrees and less than 90 degrees, and the angle range of a second included angle between the second outer inclined plane and the vertical plane perpendicular to the axial direction is more than or equal to 50 degrees and less than 90 degrees.

5. The push-to-release suture locking device of claim 2, wherein the difference in height between the distal end and the proximal end of the first outer ramp is greater than or equal to the diameter of the inner bore of the locking pin and less than the outer diameter of the locking pin.

6. The push-to-release suture locking device of claim 2, wherein the first outer bevel and the second outer bevel are rounded; the distal end surface of the push rod and the surface of the push rod close to the chuck are in smooth transition.

7. The push-to-release suture locking device of claim 2, wherein the recess is disposed at the distal end of the push rod, the recess comprising a first internal ramp and a second internal ramp intersecting the first internal ramp; when the protruding part is accommodated in the recessed part, 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 push-to-release suture locking device of claim 7, wherein an angle between a first inner slope and a second inner slope of the recess is greater than or equal to an angle between a first outer slope and a second outer slope of the protrusion.

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

10. The push-to-release suture keying device of claim 7, wherein a maximum depth of said recess is greater than or equal to a maximum height of said protrusion.

11. The push-to-release suture locking device of claim 7, wherein the second inner slope is rounded to the surface of the push rod proximate the collet.

12. The push-to-release suture locking device of claim 1, further comprising a drive assembly connected to the pusher assembly, the drive assembly comprising a threaded drive member and a flexible core fixedly connected to the threaded drive member, the threaded drive member being rotatably connected to the pusher assembly; the rotation of flexible inner core drives the screw thread driving medium is rotatory, the screw thread driving medium drive the push rod along axial displacement.

13. The push-to-release suture locking device of claim 12, further comprising an outer sleeve assembly surrounding the collet, the push rod assembly, and the transmission assembly; the outer sleeve assembly comprises a sleeve and a flexible outer tube fixedly connected with the sleeve, the chuck and the push rod assembly are accommodated in the sleeve, the chuck is fixedly connected with the sleeve, and the flexible outer tube is sleeved outside the flexible inner core.

14. The push-to-release suture keying device of claim 13, wherein said threaded drive is a drive screw; the far end of the thread transmission part is rotationally connected with the push rod component through a connecting part, and the thread transmission part synchronously rotates and axially moves to drive the push rod to axially move.

15. The push-to-release suture keying device of claim 13, wherein said threaded drive is a drive screw; the screw transmission part is directly screwed with the push rod assembly, and the screw transmission part only rotates to drive the push rod to move along the axial direction.

16. The push-to-release suture locking device of any one of claims 12 to 15, further comprising an actuating member for driving the flexible core and the thread drive member in rotation, the actuating member being fixedly attached to the proximal end of the flexible core.

17. The push-to-release suture locking device of claim 16, further comprising a handle, wherein the driving member is rotatably disposed at a proximal end of the handle.

18. The push-to-release suture locking device of claim 12, wherein the pusher bar assembly further comprises a tangent blade disposed on an opposite side of the pusher bar.