CN113491547A - Forward-pushing releasing type suture locking device - Google Patents

Abstract

Translated fromChinese

本发明提供了一种前推释放型缝合线锁结装置，用于将缝合线固定在锁钉中，包括夹头及套设于所述夹头外的推杆组件；所述锁钉容置在所述夹头的远端，所述夹头自身具有弹性；所述推杆组件包括推杆，所述推杆面朝所述夹头的一侧设有凹陷部，所述夹头面朝所述推杆的一侧设置对应所述凹陷部的凸起部；在所述推杆沿轴向持续朝远端移动的过程中，所述推杆先抵推所述凸起部逐渐升高的一侧，以迫使所述夹头压迫锁钉变形而锁紧所述缝合线；之后所述凸起部逐渐容置于所述凹陷部内，使得所述夹头至少恢复部分形变，以释放锁钉。该前推释放型缝合线锁结装置，能够避免夹头释放锁钉瞬间的剧烈跳动，大幅降低组织被撕裂的风险。

The invention provides a forward push-release type suture locking device for fixing the suture in the locking nail, comprising a collet and a push rod assembly sleeved outside the collet; the locking nail accommodates At the distal end of the collet, the collet itself has elasticity; the push rod assembly includes a push rod, the side of the push rod facing the collet is provided with a concave portion, and the collet faces One side of the push rod is provided with a convex part corresponding to the concave part; in the process of the push rod moving towards the distal end in the axial direction, the push rod first pushes against the convex part and gradually rises to force the collet to compress the locking nail to deform and lock the suture; then the raised part is gradually accommodated in the concave part, so that the collet recovers at least part of the deformation to release the lock nail. The forward push-release type suture locking device can avoid the violent jumping of the clip at the moment of releasing the locking staple, and greatly reduce the risk of tissue being torn.

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-releasesuture locking device 100 for locking a suture to astaple 300. The forward-push release typesuture locking device 100 comprises achuck 22 arranged at the far end for pressing alocking nail 300 to deform, apush rod assembly 40 sleeved outside thechuck 22 for controlling thechuck 22 to open and close, atransmission assembly 60 connected to thepush rod assembly 40, adriving member 70, a supportingtube assembly 80 surrounding thechuck 22, thepush rod assembly 40 and thetransmission assembly 60, and ahandle 90 arranged at the near end. The distal end of thecartridge 22 is provided with a space 25 (see fig. 8) for placing alocking nail 300, and thelocking nail 300 is provided with athreading cavity 301 along the axial direction, and thethreading cavity 301 is used for threading a suture. Thepush rod assembly 40 comprises apush rod 42 arranged outside thechuck 22, aconcave part 420 is arranged on one side of thepush rod 42 facing thechuck 22, thechuck 22 is fixed in axial position and elastic, and aconvex part 220 corresponding to theconcave part 420 is arranged on one side of thechuck 22 facing thepush rod 42; thetransmission assembly 60 comprises ascrew transmission member 62 and a flexibleinner core 63 fixedly connected with thescrew transmission member 62 and having a certain axial length, and the distal end of thescrew transmission member 62 is rotatably connected with thepush rod assembly 40; the flexibleinner core 63 rotates to drive thescrew transmission member 62 to rotate, and the rotation of thescrew transmission member 62 drives thepush rod assembly 40 to move axially and distally, so that thepush rod 42 moves axially and distally to push against the gradually rising side of the protrudingportion 220 of thecollet 22, thereby forcing thecollet 22 to press thelocking nail 300 to deform and lock the suture thread passing through thelocking nail 300; the flexibleinner core 63 continues to rotate in the same direction to drive thescrew transmission member 62 to rotate, and the rotation of thescrew transmission member 62 drives thepush rod assembly 40 and thepush rod 42 to continue to move axially and distally until theprotrusion 220 of thecollet 22 is gradually accommodated in therecess 420, so that thecollet 22 at least partially deforms again to release thelocking pin 300.

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

Further, thepush rod 42 is pushed to the far end along the axial direction to push against the gradually rising side of theconvex portion 220 of thechuck 22, the resistance is gradually increased in the process of profiling thelock pin 300, and the driving force required by thepush rod 42 is correspondingly gradually increased; after thepush rod 42 continues to be pushed distally along the axial direction to cross the highest point of theconvex portion 220, theconvex portion 220 is gradually accommodated in theconcave portion 420, the resistance is gradually reduced, and the driving force required by thepush rod 42 is correspondingly gradually reduced; therefore, the operator can know whether thelock 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 typesuture locking device 100 converts the rotation torque of the flexibleinner core 63 and thescrew transmission member 62 into an axial thrust force of thescrew transmission member 62 driving thepush rod 42 to move axially to drive thepush rod 42 to push towards the far end along the axial direction, and since thescrew 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 thepush rod 42 to push against thechuck 22, so that thechuck 22 can effectively press thelocking nail 300 to enable thelocking nail 300 to deform sufficiently, and the suture line is ensured to be reliably locked by thelocking nail 300.

As shown in fig. 3 and 4, the outersupport tube assembly 80 includes asleeve 82 for receiving thecollet 22 and thepush rod assembly 40, anend cap 88 secured to a distal end of thesleeve 82, aconnector barrel 84 secured to a proximal end of thesleeve 82, and a flexibleouter tube 86 secured to a proximal end of theconnector barrel 84. The threadeddriving member 62 is rotatably connected to theouter sleeve member 80, and the threadeddriving member 62 rotates relative to theouter sleeve member 80 to move thepush rod 42 in the axial direction. Thecollet 22 and thepush rod assembly 40 are disposed in thesleeve 82, thecollet 22 is fixedly coupled to thesleeve 82 such that the axial position of thecollet 22 is fixed, and the flexibleouter tube 86 is disposed over the flexibleinner core 63. Thescrew drive member 62 is rotatably connected within theconnector barrel 84, and in particular, thescrew drive member 62 is in threaded engagement with theconnector barrel 84. In this embodiment, thescrew transmission member 62 is a transmission screw, aconnection portion 67 is disposed at a distal end of thescrew transmission member 62, theconnection portion 67 is rotatably connected to thepush rod assembly 40, and thescrew transmission member 62 synchronously rotates and axially moves to drive thepush rod assembly 40 to axially move.

As shown in FIG. 4, the distal end of the flexibleouter tube 86 is fixedly connected to the proximal end of theconnector barrel 84, theconnector barrel 84 is fixedly connected between thesleeve 82 and the flexibleouter tube 86, the proximal end of the flexibleouter tube 86 is fixedly connected to the distal end of thehandle 90, the lumen of the flexibleouter tube 86 communicates with the lumen of theconnector barrel 84, and theconnector barrel 84 is threadedly connected to the threadeddrive member 62. The flexibleouter 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 flexibleouter tube 86 is laser cut. The flexibleouter tube 86 may be made of stainless steel, nickel-titanium alloy, cobalt-chromium alloy, etc., and in this embodiment, the flexibleouter tube 86 is made of nickel-titanium alloy.

Thesleeve 82 is a hollow tube, the proximal end of thesleeve 82 is snapped onto the distal end of theconnector barrel 84, and the distal end of thesleeve 82 is snapped onto theend cap 88. Thethreading slot 820 is formed in the peripheral wall of thesleeve 82 near thecollet 22, and thethreading slot 820 is used for the threading of the suture thread passing through thelocking nail 300. The distal end of theend cap 88 defines asuture inlet 880 communicating with the lumen of thesleeve 82, and thelocking pin 300 is inserted into the lumen of thesleeve 82 through thesuture inlet 880.

Referring to fig. 5 and 6, thelocking pin 300 includes alocking cylinder 302 and a circular truncatedcone 303 disposed at a distal end of thelocking cylinder 302. The outer diameter of the circular truncatedcone 303 of thelocking pin 300 is larger than the outer diameter of thelocking cylinder 302. Threadinglumen 301 oflocking nail 300 is axially disposed through opposing ends oflocking nail 300, threadinglumen 301 being adapted to receive and pass a suture. The lockingbarrel 302 may be collapsed upon application of a mechanical force to secure the suture in thethreading lumen 301 of thelocking pin 300. Thelocking pin 300 may be of various shapes, e.g., cylindrical, prismatic, oval, etc., so long as it has a threadedcavity 301 for receiving a suture. The distal opening of thethreading lumen 301 of the lockingnail 300 smoothly transitions with the distal surface of the lockingnail 300 to avoid the junction therebetween cutting the suture or scratching the internal tissue of the patient. Thelocking 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 thelocking pin 300 is not compressed by an external force, the initial height h1 of the middle portion of thelocking pin 300 is equal to the outer diameter of thelock barrel 302 of thelocking pin 300; as shown in fig. 6, when thelock cylinder 302 of thelock pin 300 is collapsed by mechanical external force, the suture is fixed in thethreading cavity 301 of thelock pin 300, and the collapsed height h2 of thelock pin 300 is smaller than the initial height h 1.

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

Referring to fig. 8 and 9, thechuck 22 includes afirst chuck 221 and asecond chuck 223 formed integrally and disposed oppositely, and theprotrusion 220 is disposed on a side of thefirst chuck 221 away from thesecond chuck 223. Thegap 25 is formed between the first andsecond collets 221 and 223. When the drivingmember 70 drives thescrew transmission member 62 to rotate, because the position of the connectingcylinder 84 is fixed, thescrew transmission member 62 rotates and moves axially to push thepush rod 42 to move axially, i.e. the rotation of thescrew transmission member 62 is converted into the axial movement of thepush rod 42, so that thepush rod 42 slidably pushes against the protrusion 200 of thecollet member 22 to drive thefirst collet 221 and thesecond collet 223 to move toward each other and press the lockingnail 300, so that the lockingnail 300 deforms and is fixed to the suture.

In this embodiment, thefirst chuck 221 and thesecond chuck 223 are integrally formed by an elastic hard material, the proximal end of thechuck 22 is closed, apin 24 perpendicular to the axial direction penetrates through the proximal end of thechuck 22, and opposite ends of thepin 24 are respectively fixed to thesleeves 82. Thepin 24 positions thecartridge 22 and prevents thecartridge 22 from moving axially. The physical location of the proximal ends of the first andsecond collets 221, 223 provides support and power for thefirst collet 221 to rebound.

In this embodiment, the protrudingportion 220 is located at a distal end of a side of thefirst collet 221 facing away from thesecond collet 223, the protrudingportion 220 includes a first outerinclined surface 2201 and a second outerinclined surface 2203 intersecting with each other, the first outerinclined surface 2201 and the second outerinclined surface 2203 intersect with each other at a side of thefirst collet 221 facing away from thesecond collet 223, the first outerinclined surface 2201 gradually increases from a proximal end to a distal end thereof, and the second outerinclined surface 2203 gradually decreases from the proximal end to the distal end thereof. As shown in fig. 4 and fig. 9, the first outerinclined surface 2201 corresponds to the side of theprotrusion 220 that gradually rises, and the distal end of thepush rod 42 axially slidably pushes the first outerinclined surface 2201 to press thefirst collet 221 gradually to close to thesecond collet 223, so as to press the lockingpin 300. Pushing thepush rod 42 distally continues until theprotrusion 220 is gradually received in therecess 420, thecollets 22 rebound, thefirst collet 221 is away from thesecond collet 223, and the gap between the first andsecond collets 221 and 223 increases to a height h2 greater than the collapsed height of thelocking pin 300 to release thelocking pin 300. Further, the side of the distal end of thefirst clamping head 221 facing thegap 25 is provided with afirst clamping tooth 2215, and thefirst 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 firstouter slope 2201 is located at the proximal end of the protrudingportion 220, and the firstouter slope 2201 gradually extends from the proximal end to the distal end thereof to a side away from thesecond collet 223; the secondouter slope 2203 is located at the distal end of the protrudingportion 220, and the secondouter slope 2203 gradually extends from the proximal end to the distal end toward the side near thesecond collet 223. An included angle a is formed between the first outerinclined surface 2201 and the second outerinclined surface 2203 of theboss 220, and preferably, a is more than or equal to 120 degrees and less than 180 degrees. Further, when thecollet 22 is in the initial state (or referred to as the natural state, which means the state before thecollet 22 is pushed by the push rod 42), the angle range of the first included angle a1 between the first outerinclined 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 outerinclined 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 outerinclined surface 2201 and the second outerinclined surface 2203. It is noted that a2 < a1, or the slope of the firstouter slope 2201 is smaller than the slope of the secondouter slope 2203, and the slope of the firstouter slope 2201 is more gradual, which helps to reduce the driving force for pushing thepush rod 42 to push thepush rod 42 against and press thecollet 22, allowing thecollet 22 to deform gradually.

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

Referring to fig. 8 and 9, the height difference H between the highest point of the protrudingportion 220 before thefirst 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 thenail 300 is compressed. Specifically, the vertical length between the highest point of the protrudingportion 220 before thefirst collet 221 deforms and the axial plane passing through the axis of thepin 24 is H2 (as shown in fig. 8), the vertical length between the highest point of the protrudingportion 220 and the axial plane passing through the axis of thepin 24 is H3 (as shown in fig. 9) after thefirst 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 thelocking pin 300 and the height H2 after the compression of thelocking pin 300, so that thelocking pin 300 can be smoothly taken out of thegap 25 of thecollet 22; when the difference H is 0, thefirst collet 221 is completely restored to the initial state.

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

The side of thesecond jaw 223 facing thefirst jaw 221 adjacent the distal end is provided withsecond clamping teeth 2235, thesecond clamping teeth 2235 including a plurality of gullets, each gullet of thesecond clamping teeth 2235 extending in the same direction as the gullet of thefirst clamping teeth 2215. When thefirst cartridge 221 and thesecond cartridge 223 are moved toward each other along thepin 24, thefirst teeth 2215 of thefirst cartridge 221 and thesecond teeth 2235 of thesecond cartridge 223 are misaligned and engaged with each other, so that thefirst cartridge 221 is elastically deformed toward thesecond cartridge 223, and thefirst teeth 2215 and thesecond teeth 2235 press the lockingpin 300 placed in thegap 25 into a shape having a curvature. The proximal end of the side of thesecond clamping head 223 facing away from thefirst clamping head 221 is provided with a horizontal slidingguide surface 2236, and the slidingguide surface 2236 is provided with athreading hole 2237 communicating with thegap 25, so that a suture thread passing through the lockingnail 300 can conveniently pass through thethreading hole 2237. Apositioning block 2233 is convexly arranged at the far end of the side surface of thesecond chuck 223 departing from thefirst chuck 221, the near end surface of thepositioning block 2233 is close to thethreading hole 2237, and the near end surface of thepositioning block 2233 is atangential surface 2238.

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

Therecess 420 is disposed on a side of thepush rod 42 proximate to thefirst jaw 221 and near a distal end of thepush rod 42.Recess 420 includes intersecting firstinterior slope 4201 and secondinterior slope 4203, firstinterior slope 4201 being further from the distal face ofpushrod 42 than secondinterior slope 4203. When the protrudingportion 220 is received in the recessedportion 420, the first outerinclined surface 2201 corresponds to the first innerinclined surface 4201, and the second outerinclined surface 2203 corresponds to the second innerinclined surface 4203.

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

An included angle b between the first innerinclined surface 4201 and the second innerinclined surface 4203 of theconcave portion 420 is greater than or equal to an included angle a between the first outerinclined surface 2201 and the second outerinclined surface 2203 of theconvex portion 220, so that theconvex portion 220 is accommodated in theconcave portion 420. Preferably, a third included angle b1 between the first innerinclined 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 innerinclined 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 firstinterior slope 4201 and the secondinterior slope 4203.

As shown in fig. 11, the maximum depth H4 of theconcave portion 420 is the vertical length from the highest point of theconcave portion 420 to the surface of thepush rod 42 adjacent to thecartridge 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 outerinclined surface 2201, or the maximum height of theconvex portion 220, so as to ensure that theconvex portion 220 can be completely accommodated in theconcave portion 420, and provide sufficient rebound space for thecartridge 22; when the raisedportion 220 is received in the recessedportion 420, the height of the void 25 is greater than the height h2 of thepin 300 after it has been collapsed to facilitate release of thepin 300.

Thecutting blade 46 has acutting edge 461 at a distal end thereof, and when theprotrusion portion 220 is completely received in therecess portion 420, thecutting edge 461 abuts against the cuttingsurface 2238 to cut the suture thread passing through thethreading hole 2237.

It is understood that in other embodiments, the shape of the protrudingportion 220 may also be a protrusion in the shape of a hemisphere, a truncated cone, a cone, etc., and the shape of the recessedportion 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 protrudingportion 220.

Referring to fig. 3, 4 and 12-14, the flexibleinner core 63 includes a flexibleinner tube 64 connected to the proximal end of thescrew drive 62 and astem 66 inserted into the inner cavity of the flexibleinner tube 64, and the connectingportion 67 is connected between the distal end of thescrew drive 62 and thebase 44 of thepush rod assembly 40. A flexibleinner tube 64 is wrapped around acore rod 66, the flexibleinner tube 64 and thecore rod 66 together forming a flexibleinner core 63. Thescrew driver 62 includes a drivingscrew 621, and the drivingscrew 621 is screwed to the internal thread of the connectingcylinder 84. The distal end of the flexibleinner tube 64 is fixedly connected to the threadedtransmission member 62, the proximal end of the flexibleinner tube 64 is fixedly connected to the drivingmember 70, and the drivingmember 70 is used for driving the flexibleinner core 63 and the threadedtransmission member 62 to rotate. The flexibleinner 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 flexibleinner tube 64 is smaller than the inner diameter of the flexibleouter tube 86. Rotation of the flexibleinner tube 64 relative to theconnector barrel 84 rotates and moves thescrew drive 62 axially.

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

The drivingscrew 621 rotates and moves axially to drive the connectingportion 67 to rotate relative to thebase 44, and meanwhile, the distal end of the drivingscrew 621 pushes thebase 44, thepush rod 42 and thecutting blade 46 to move axially toward the distal end.

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

As shown in fig. 3 and 13, the drivingmember 70 is connected to the proximal end of thetransmission assembly 60, specifically, the drivingmember 70 is a rotating member rotatably disposed at the proximal end of thehandle 90, and the proximal ends of the flexibleinner tube 64 and thecore rod 66 are fixedly connected to the drivingmember 70. Rotation of the drivingmember 70 causes the flexibleinner tube 64 and thecore pin 66 to rotate together. The outer wall of the drivingmember 70 is provided with ananti-slip mechanism 79, and the drivingmember 70 can be conveniently rotated by holding theanti-slip mechanism 79 by hand.

Referring to fig. 2, fig. 3, fig. 15 and fig. 16, the drivingmember 70 is rotatably connected to the proximal end of thehandle 90, at least onelength scale 915 is axially disposed on thehandle 90 adjacent to the drivingmember 70, and the at least onelength scale 915 is used for displaying the displacement amount of the drivingmember 70 moving axially. When the distal surface ofdriver 70 is aligned with 0 onlength scale 915, first andsecond collets 221 and 223 ofcollet 22 are in a fully expanded state, and pushrod 42 does not apply an axial pushing force tocollet 22; when the drivingmember 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 thelength scale 915, thepush rod 42 pushes against the highest point of theprotrusion 220 of thecollet 22, and thefirst collet 221 and thesecond collet 223 press the lockingnail 300 to deform and fix the suture thread passing through the lockingnail 300; as thedriver 70 continues to rotate in the same direction and moves axially until its distal surface is aligned with another scale value on thelength scale 915, such as "7.5", theprotrusions 220 on thecollet 22 are received in therecesses 420 of thepush rod 42 and thefirst collet 221 portion of thecollet 22 resiliently returns away from thesecond collet 223 to facilitate release of thelocking pin 300.

Referring to fig. 17-23, the use of the push-to-releasesuture 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 ormore sutures 500 withelastic 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 thesutures 500 and the leaflets is converted into the surface contact between theelastic 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 ofsutures 500 on three leaflets are all threaded into thethreading cavity 301 of the lockingnail 300 of the forward-release-typesuture locking device 100 outside the patient, and the proximal ends of thesutures 500 are sequentially threaded through thethreading cavity 301 of the lockingnail 300, thegap 25 between thefirst clamping head 221 and thesecond clamping head 223 and thethreading hole 2237 and then are threaded out of the threadinggroove 820 of thesleeve 82;

the third step: pushing the distal end of the forward-push releasesuture 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 thesuture 500 until the distal end of the forward-push releasesuture locking device 100 reaches a predetermined position in the right atrium;

the fourth step: adjusting the tightness of the threeleaflet 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 ofsutures 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 drivingmember 70 on thehandle 90 is rotated, thescrew transmission member 62 moves axially and distally at the same time, and drives the drivingmember 70, the flexibleinner core 63, and thescrew transmission member 62 to move axially and distally along the rotating edge, thescrew transmission member 62 pushes thepush rod assembly 40 to move axially and distally, during the axial distal movement of thepush rod assembly 40, thepush rod 42 moves distally relative to thecollet 22, the distal end of thepush rod 42 continuously pushes and presses the first outerinclined surface 2201 on thefirst collet 221 until reaching the highest point of theprotrusion 220, so that thefirst collet 221 approaches thesecond collet 223, and the firstgripping tooth 2215 and the secondgripping tooth 2235 press and grip the lockingnail 300 accommodated in thegap 25 until the lockingnail 300 deforms, and the three groups ofsutures 500 in the lockingnail 300 are locked together.

And a sixth step: as shown in fig. 19, 20 and 23, by further rotating the drivingmember 70 on thehandle 90 in the same rotational direction, thescrew drive 62 continues to move axially and distally to drive thepush rod 42 to move distally until theprotrusions 220 on thefirst jaw 221 enter therecesses 420 of thepush rod 42, thejaw 22 releases thestaple 300, thecutting blade 46 cuts thesuture 500, and thestaple 300 is released from thegap 25 of thejaw 22; then theredundant suture thread 500 is drawn out of the body of the patient through the locking path;

the seventh step: the distal end of theknotting device 100 is withdrawn from the patient and thelocking pin 300 remains in the patient, at which point the lockingpin 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 thepush rod assembly 40a and thescrew transmission member 62a in the second embodiment is slightly different from that in the first embodiment, and the connection structure of thepush rod assembly 40a and thescrew 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 achuck 22, apush rod assembly 40a, a transmission assembly and an outer casing assembly 80a, wherein thescrew transmission member 62a is rotatably connected to the outer casing assembly 80a, thescrew transmission member 62a and thepush rod assembly 40a are in screw-fit transmission, thescrew transmission member 62a only rotates, and the rotation of thescrew transmission member 62a is converted into the axial movement of thepush rod 42 through the screw transmission between thescrew transmission member 62a and thepush rod assembly 40 a.

Thescrew driving element 62a includes a drivingscrew 621 at a distal end and a connectingrod 625 extending axially from a proximal end of the drivingscrew 621, and astop ring 627 is radially disposed on an outer wall of the proximal end of the drivingscrew 621.

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

The outer sleeve component 80a omits a connecting cylinder of theouter sleeve component 80 in the first embodiment, anannular flange 842 is arranged on the inner wall of thesleeve 82 corresponding to thescrew driver 62a, the proximal end of thescrew driver 62a is rotatably inserted into theflange 842, astop ring 627 is arranged on the outer peripheral wall of thescrew driver 62a at the distal end of theflange 842, thescrew driver 62a is fixedly connected with a fixingring 68 at the proximal end of theflange 842, a rotating groove is defined by thestop ring 627 and the fixingring 68, theflange 842 is rotatably accommodated in the rotating groove, and the distal end of the flexibleouter tube 86 is fixedly connected with the proximal end of thesleeve 82. Since thestop ring 627 is stopped at the distal end surface of theflange 842 and the fixingring 68 is stopped at the proximal end surface of theflange 842, the connectingrod 625 and thescrew drive 62a can only be rotated and cannot be moved axially.

In this embodiment, the connectingtube 84 is omitted and the drivingscrew 621 of thescrew driving element 62a directly drives the base 44a of thepush 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 screwdrive 62 in place and the base 44a moves thepush rod 42 distally relative to thecollet 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 (18)

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.

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