CN110575210A

CN110575210A - Adjustable suture locking device

Info

Publication number: CN110575210A
Application number: CN201810587805.9A
Authority: CN
Inventors: 张伟伟; 张庭超; 郑贤章
Original assignee: Hangzhou De Jin Medical Technology Co Ltd
Current assignee: Hangzhou De Jin Medical Technology Co Ltd
Priority date: 2018-06-08
Filing date: 2018-06-08
Publication date: 2019-12-17

Abstract

The invention provides an adjustable suture locking device which comprises a locking nail, an outer tube, a handle and an adjusting device, wherein the locking nail is used for accommodating or fixing a suture; the outer tube is internally provided with a cavity, and the locking nail is arranged at the far end of the cavity; the handle comprises a fixing part which is connected with the near end of the outer tube; the adjusting device is arranged on the fixing part, is connected with the proximal end of the suture and is used for adjusting the tightening or loosening of the suture. The adjustable suture locking device provided by the invention can be used for timely adjusting the length of the suture according to the treatment effect in the process of fixing the suture in the minimally invasive surgery or interventional operation, so that the operation effect is enhanced, and the operation success rate is improved.

Description

Adjustable suture locking device

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to an adjustable 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 can be performed manually by a doctor. However, with the advance of technology, various minimally invasive and interventional procedures, such as laparoscopic procedures, transcatheter interventional procedures, etc., are becoming more common, which require a small operating window to be cut in 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, tying or securing the suture typically requires the operator to remotely manipulate the suture through a small manipulation window outside the patient's body to tie the suture in the patient's body.

In the prior art, surgical robots, knot pushers, or transcatheter suture locking implant systems are often used to remotely knot or secure sutures. However, when these methods are used to lock the suture, the length of the suture cannot be adjusted according to the surgical condition and the therapeutic effect.

Disclosure of Invention

in view of the above, the present invention provides an adjustable suture locking device. The specific technical scheme is as follows:

An adjustable suture locking device, comprising:

A locking nail for accommodating or fixing a suture;

the locking nail is arranged at the far end of the accommodating cavity;

A handle comprising a fixation portion connected with a proximal end of the outer tube;

Adjusting device, adjusting device locates on the fixed part, adjusting device with the stylolite proximal end is connected, and is used for adjusting the tightening or the loosening of stylolite.

Preferably, the adjustment device comprises a cable tie movably connected to the fixing portion, the cable tie being connected to the proximal end of the suture to adjust the tightening or loosening of the suture.

preferably, the adjusting device further comprises an adjusting track, the adjusting track is arranged on the fixing part, and the wire harness is connected to the fixing part through the adjusting track; the wire harness advances or retreats on the adjusting track along the axial direction of the adjusting track, so that the tightening or loosening of the suture is adjusted.

Preferably, the buncher includes suture fixed part and handle connecting portion of interconnect, the suture fixed part with can dismantle the connection between the suture, the handle connecting portion set up in adjusting the track, the buncher passes through the handle connecting portion is in adjust orbital upward along adjusting orbital axial direction and advance or retreat.

Preferably, the suture fixing portion includes a winding shaft, and a first blocking portion and a second blocking portion connected to both ends of the winding shaft, wherein the second blocking portion is farther from the handle connecting portion than the first blocking portion.

Preferably, the suture fixing part further comprises a spring piece, the spring piece is fixed on the second blocking part, and the spring piece is used for fixing the suture.

Preferably, the adjusting track comprises a track cavity and a track outer wall, the handle connecting portion comprises an embedding end and a connecting shaft, the embedding end is located in the track cavity and moves back and forth in the track cavity, the connecting shaft is located on the track outer wall and moves back and forth on the track outer wall, and the embedding end is connected with the suture line fixing portion through the connecting shaft.

Preferably, the outer wall of the track is provided with first teeth, the connecting shaft is provided with second teeth, and the first teeth and the second teeth are matched so that the connecting shaft rolls on the outer wall of the track.

Preferably, the adjusting device further comprises a lead screw, a bolt and an adjusting knob, the lead screw is fixed in the fixing part along the axial direction of the adjusting track, the bolt is fixed in the fixing part, and the lead screw passes through the bolt and is matched with the bolt; the proximal end of the lead screw penetrates out of the proximal end of the fixing part and is connected with the adjusting knob; the handle connecting part is fixed on the guide screw rod; the adjusting knob adjusts the lead screw to advance or retreat in the axial direction.

Preferably, the handle further comprises a movable part, the movable part and the fixed part can move relatively, the locking nail is provided with a hollow inner cavity along the axial direction, and the hollow inner cavity is used for accommodating and passing the suture; the adjustable suture locking device further comprises:

the pressing and holding assembly is used for pressing and holding the lock nail and deforming the lock nail;

the far end of the mandrel is connected with the near end of the pressing and holding assembly, and the near end of the mandrel is movably connected with the movable part;

The pressing and holding assembly and the mandrel are located in the containing cavity, the movable part moves relative to the fixed part, and the mandrel is driven to move so that the pressing and holding assembly presses and holds the locking nail.

Preferably, the pressing and holding assembly comprises a chuck and a push rod, the chuck comprises an upper clamping piece, a lower clamping piece and a clamping piece connecting part connected between the near end of the upper clamping piece and the near end of the lower clamping piece, and the locking nail is accommodated between the upper clamping piece and the lower clamping piece; the near-end of push rod with the distal end of dabber is connected, the distal end of push rod is close to go up the clamping piece setting, the dabber drive the push rod to go up the clamping piece and remove, and then promote go up the clamping piece to lower clamping piece removes so that go up the clamping piece with lower clamping piece is pressed together and is held the staple.

Preferably, the upper clamping piece comprises a first surface facing the locking nail, the lower clamping piece comprises a second surface facing the locking nail, the first surface is provided with a first occlusion part, the second surface is provided with a second occlusion part, and the first occlusion part is matched with the second occlusion part so as to enable the upper clamping piece and the lower clamping piece to be closed.

preferably, the distal end of the push rod comprises a first slope, and the first slope is inclined downwards from the distal end to the proximal end; the upper clamping piece comprises a second inclined surface facing away from the locking nail, and the second inclined surface inclines downwards from the far end to the near end.

Preferably, the slope of the first slope is smaller than the slope of the second slope. The inclination of the first inclined surface is an included angle between the first inclined surface and the push rod in the direction from the far end to the near end, and the inclination of the second inclined surface is an included angle between the second inclined surface and the push rod in the direction from the far end to the near end.

Preferably, the hollow inner cavity comprises an upper surface and a lower surface which are oppositely arranged, the upper surface is provided with a convex locking platform, the lower surface is provided with a concave locking hole, and the locking platform is matched with the locking hole.

Preferably, the distal end of the outer tube is provided with a suture inlet along the radial direction, and the diameter of the suture inlet is at least equal to the diameter of the position where the outer diameter of the locking nail is the largest; the outer tube is also provided with a suture outlet; the suture line inlet and the suture line outlet are communicated with the hollow inner cavity of the locking nail.

Preferably, the distal end of the outer tube comprises a retaining portion, the diameter of which gradually decreases from the proximal end to the distal end.

Preferably, the holding portion includes a holding portion end surface at a distal end; the holding part is provided with an opening which is communicated with the end face of the holding part along the axial direction, and the opening is communicated with the cavity.

Preferably, the opening is provided with a protrusion along the radial direction, a preset distance is reserved between the protrusion and the end face of the holding part, and part of the lock pin is arranged in the opening so that the protrusion can fix the lock pin.

Preferably, the distal end of staple is equipped with the round platform, the diameter of round platform is greater than the diameter of the proximal portion of staple, the round platform sets up in the opening, the arch is fixed the staple.

Preferably, the circular truncated cone comprises an inner side surface, and the inner side surface is an arc-shaped curved surface.

Compared with the prior art, the invention at least has the following beneficial effects: the adjustable suture locking device provided by the invention can be used for timely adjusting the length of the suture according to the treatment effect in the process of fixing the suture in the minimally invasive surgery or interventional operation, so that the operation effect is enhanced, and the operation success rate is improved.

drawings

fig. 1 is a schematic structural view of an adjustable suture locking device according to a first embodiment of the present invention.

FIG. 2 is a schematic view of a staple of the present invention before and after it is secured to a suture.

FIG. 3 is a schematic view of a handle portion of an adjustable suture locking device according to a first embodiment of the present invention.

Fig. 4 is a schematic view of a suture restraint device of an adjustable suture locking device according to a first embodiment of the present invention.

FIG. 5 is a schematic view of a suture retaining portion of a suture restraint in a suture cinch of an adjustable suture keying arrangement according to a first embodiment of the present invention.

Fig. 6 is a partially enlarged view of a portion a in a view c of fig. 3.

Fig. 7 is a schematic view of a handle portion of an adjustable suture locking device according to a second embodiment of the present invention, wherein B is a cross-sectional view taken along line B-B of a.

Fig. 8 is a partially enlarged view of a portion B of fig. 7B.

Fig. 9 is a schematic structural view of an adjustable suture locking device according to a third embodiment of the present invention.

fig. 10 is a schematic view of an adjustment device in an adjustable suture locking device according to a third embodiment of the present invention.

Fig. 11 is a schematic cross-sectional view of a locking pin according to the present invention.

Fig. 12 is another schematic cross-sectional view of a locking pin according to the present invention.

fig. 13 is a schematic structural diagram of the squeezing assembly provided by the present invention.

FIG. 14 is a schematic view of a crimp pin of an adjustable suture locking device provided in accordance with the present invention.

Fig. 15 is a partial enlarged view of the b view at C in fig. 14.

FIG. 16 is a schematic view of a retaining portion of an adjustable suture locking device according to the present invention.

Fig. 17 is a schematic view illustrating the implantation of sutures to the anterior leaflet and the posterior leaflet, respectively, of the leaflet of the present invention.

FIG. 18 is a schematic view of an adjustable suture locking device for threading a suture provided by the present invention.

FIG. 19 is a schematic view of the present invention providing for adjustment of suture length and crimping of a staple with an adjustable suture keying device.

Fig. 20 is a schematic view of the adjustable suture locking device being pushed proximal to a leaflet as provided by the present invention.

FIG. 21 is a schematic view of the present invention providing for the fixation of the proximal end of a suture to the ventricular wall or apex via a locking staple.

Detailed Description

While the following is a description of the preferred embodiments of the present invention, it will be understood by those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the invention.

Orientation definition: hereinafter, a position close to the operator is defined as a proximal end, and a position far from the operator is defined as a distal end.

Referring to fig. 1, a first embodiment of the present invention provides an adjustable suture locking device 100, where the adjustable suture locking device 100 includes a locking nail 1000, an outer tube 2000, a handle 3000, and an adjusting device 4000, the locking nail 1000 is used to accommodate or fix a suture 5000 (see fig. 2, a represents before the locking nail is not fixed, and b represents after the locking nail is fixed), the outer tube 2000 has a cavity 2100 therein, and the locking nail 1000 is disposed at a distal end of the cavity 2100 (see fig. 15). The handle 3000 includes a fixing portion 3100, and the fixing portion 3000 is connected to the proximal end of the outer tube 2000. The adjusting device 4000 is disposed on the fixing portion 3100 (see fig. 3), and the adjusting device 4000 is connected to a proximal end of the suture 5000 and is configured to adjust tightening or loosening of the suture 5000. It is understood that adjustment device 4000 can be any device capable of tightening or loosening suture 5000. Such as a cable tie or a snap. It will be appreciated that the number of adjustment devices 4000 may be set as desired, and preferably, one adjustment device 4000 is provided on each side of the fixing portion 3100 for adjusting the two sets of suture threads 5000.

The adjustable suture locking device 100 provided by the invention can be used for timely adjusting the length of the suture 5000 by using the adjusting device 4000 according to the treatment effect in the process of fixing the suture in the minimally invasive surgery or interventional operation, thereby enhancing the operation effect and improving the operation success rate.

Please refer to fig. 3. In a further embodiment, the adjustment device 4000 includes a wire harness 4100, the wire harness 4100 being movably attached to the fixation portion 3100, the wire harness 4100 being coupled to a proximal end of the suture 5000 to adjust tightening or loosening of the suture 5000. The suture line 5000 can be adjusted to be tightened or loosened through the wire harness 4100, the length of the suture line 5000 to be tightened can be effectively controlled, and the effect of adjusting the length to be smaller can be achieved. For example, one of the bunchers 4100 means that the suture 5000 is tightened or loosened by winding the suture 5000 around the buncher 4100 and changing the winding direction or winding manner.

In a further embodiment, the adjusting device 4000 further includes an adjusting rail 4200, the adjusting rail 4200 is disposed on the fixing portion 3100, and the wire harness 4100 is connected to the fixing portion 3100 through the adjusting rail 4200. The wire harness 4100 is advanced or retreated on the adjustment track 4200 in an axial direction of the adjustment track 4200, thereby adjusting the tightening or loosening of the suture 5000. It will be appreciated that the suture 4100 adjusts the tightening or loosening of the suture 5000 by rolling on the adjustment track 4200. It will be appreciated that the axial direction of the adjustment track 4200 may be aligned with the axial direction of the adjustable suture keying arrangement 100 as a whole or may be angled to allow the suture holder 4100 to roll on the adjustment track 4200 to allow for adjustment of the tightening or loosening of the suture 5000. Wherein the axial direction of the adjustable suture keying device 100 as a whole is in the direction from the proximal end to the distal end.

Referring to fig. 4 and 3, in a further embodiment, the suture holder 4100 comprises a suture fixing portion 4110 and a handle connecting portion 4120 connected to each other, wherein the suture fixing portion 4110 is detachably connected to the suture 5000. The suture fixing device 4110 may be fixed to the suture 5000 by winding, clipping, and fastening. The handle coupling portion 4120 is provided in the adjustment rail 4200 (see fig. 6), and the wire harness 4100 is advanced or retreated on the adjustment rail 4200 in an axial direction of the adjustment rail 4200 by the handle coupling portion 4120. The handle connecting portion 4120 is provided in the adjustment rail 4200 by means of engagement or the like, and it is ensured that the wire harness 4100 does not fall off the handle 3000.

Referring to fig. 4 b, in a further embodiment, the suture fixing portion 4110 includes a winding shaft 4111, and a first blocking portion 4112 and a second blocking portion 4113 connected to both ends of the winding shaft 4111, wherein the second blocking portion 4113 is far away from the handle connecting portion 4120 than the first blocking portion 4112. When the suture 5000 is wound on the winding shaft 4111, the first blocking portion 4112 and the second blocking portion 4113 at the two ends can effectively block the suture 5000 from falling off from the winding shaft 4111. It can be understood that the diameters of the first and second stoppers 4112 and 4113 are larger than the diameter of the winding shaft 4111.

Referring to a in fig. 4, in a further embodiment, the suture fixing portion 4110 further includes a resilient tab 4114, the resilient tab 4114 is fixed on the second blocking portion 4113, and the resilient tab 4114 is used to fix the suture 5000. Referring to fig. 5, it can be understood that the second blocking portion 4113 is provided with a spring receiving groove 4115, and the spring 4114 is received in the spring receiving groove 4115. After the suture 5000 is wound on the winding shaft 4111 for several turns, the proximal end of the suture 5000 is fixed to the elastic piece 4114 and received in the elastic piece receiving groove 4115, so as to fix the proximal end of the suture 5000 to the wire harness 4100. It can be understood that the spring plate accommodating groove 4115 may be configured to have a shape of a corner, the spring plate 4114 is configured to be matched with the corner, and the configuration of the corner makes the suture line 5000 not easily fall off from the spring plate 4114, and is more stably fixed.

Please refer to fig. 3 and fig. 6. Wherein fig. 6 is a partially enlarged view of a portion a of a view c in fig. 3. In a further embodiment, the adjustment track 4200 comprises a track cavity 4210 and a track outer wall 4220, the handle connecting portion 4120 comprises an embedded end 4121 and a connecting shaft 4122, the embedded end 4121 is located in the track cavity 4210 and moves back and forth in the track cavity 4210, the connecting shaft 4122 is located on the track outer wall 4220 and moves back and forth on the track outer wall 4220, and the embedded end 4121 is connected with the suture fixing portion 4110 through the connecting shaft 4122. The embedded end 4121 is positioned in the track cavity 4210 and is retained in the track cavity 4210 by the track outer wall 4220 and is not easily removed from the track cavity 4210.

A second embodiment of the present invention provides an adjustable suture locking device 100 a. Referring to fig. 7 and 8, wherein a in fig. 7 is a right side view looking from the direction of the handle of the adjustable suture locking device 100a, B in fig. 7 is a sectional view taken along line B-B in a in fig. 7, and fig. 8 is an enlarged view of a portion of B in fig. 7 at B. The adjustable suture locking device 100a differs from the adjustable suture locking device 100 of the first embodiment in that a first tooth 4221 is provided on the track outer wall 4220, a second tooth 4123 is provided on the coupling shaft 4122, and the first tooth 4221 and the second tooth 4123 are adapted to allow the coupling shaft 4122 to roll on the track outer wall 4220. Thereby enabling the wire harness 4100 to advance or retreat on the adjustment track 4200 in the axial direction of the adjustment track 4200. When the operator rotates the wire harness 4100, the wire harness 4100 moves axially along the adjustment track 4210, and the rotational movement of the wire harness 4100 can be converted into a linear movement of the suture 5000, so that the tightening and loosening of the suture 5000 can be precisely achieved.

a third embodiment of the present invention provides an adjustable suture locking device 100 b. Please refer to fig. 9 and 10. In a further embodiment, adjustable suture keying device 100b differs from adjustable suture keying device 100 of the first embodiment in that adjustment device 4000 further comprises lead screw 4300, bolt 4400, and adjustment knob 4500, lead screw 4300 is fixed in fixed portion 3100 along the axial direction of adjustment track 4200, bolt 4400 is fixed in fixed portion 3100, and lead screw 4300 passes through bolt 4400 and fits to bolt 4400. The proximal end of the lead screw 4300 extends out of the proximal end of the fixing portion 3100 and is connected to the adjustment knob 4500. The handle connecting portion 4120 is fixed to the lead screw 4300. The adjustment knob 4500 adjusts the lead screw 4300 to advance or retreat in the axial direction. When the adjustment knob 4500 is rotated by an operator, the adjustment knob 4500 drives the lead screw 4300 to rotate within the fixing portion 3100, thereby driving the wire harness 4100 connected to the lead screw 4300 to move axially forward or backward in the adjustment track 4200.

Please refer to fig. 1 again. In a further embodiment, the handle 3000 further comprises a movable portion 3200, the movable portion 3200 and the fixed portion 3100 are relatively movable, and the locking nail 1000 is axially provided with a hollow inner cavity 1100 (see fig. 11), and the hollow inner cavity 1100 is used for accommodating and passing the suture 5000. Adjustable suture locking device 100 further includes a crimping assembly 6000 and a mandrel 7000. The pressing component 6000 is used for pressing the locking nail 1000 and deforming the locking nail 1000 (refer to fig. 2, wherein a in fig. 2 represents before deformation, b in fig. 2 represents after deformation). Staple 1000 can be compressed when subjected to a mechanical force to secure suture 5000 in staple 1000 against further relative movement with staple 1000, thereby locking and securing suture 5000. The staple 1000 can be of a variety of shapes, e.g., cylindrical, prismatic, etc., as long as it has a hollow interior 1100 for receiving the suture 5000. In this embodiment, a cylindrical shape is used to reduce the resistance to pressure gripping.

The distal end of mandrel 7000 is connected with the proximal end of crimping assembly 6000, and the proximal end of mandrel 7000 is movably connected with movable part 3200. The pressing and holding assembly 6000 and the mandrel 7000 are located in the cavity 2100, the movable portion 3200 moves relative to the fixed portion 3100, and the mandrel 7000 is driven to move so that the pressing and holding assembly 6000 presses and holds the locking nail 1000. It will be appreciated that mandrel 7000 applies a force to crimping assembly 6000 during movement, thereby providing crimping assembly 6000 with a mechanical force that crimps staple 1000 to crimp staple 1000. The core shaft 7000 can extend into the fixing portion 3100, and the movable connection portion 3210 between the movable portion 3200 and the core shaft 7000 is located in the fixing portion 3100 (see fig. 14).

referring to fig. 12, in a further embodiment, in the locking nail 1000, the hollow inner cavity 1100 includes an upper surface 1110 and a lower surface 1120 which are oppositely arranged, the upper surface 1110 is provided with a convex locking platform 1111, the lower surface 1120 is provided with a concave locking hole 1121, and the locking platform 1111 is matched with the locking hole 1121. It is understood that the upper and lower surfaces are named when the pin 1000 is placed horizontally, and may also be referred to as left and right surfaces when the pin 1000 is placed vertically. When the nail 1000 starts to deform by external pressure and grip, the convex locking pad 1111 is pressed into the concave locking hole 1121, and when the nail 1000 continues to deform, the locking pad 1111 and the locking hole 1121 are simultaneously deformed until they cannot be separated, and at this time, the suture 5000 is firmly fixed in the hollow inner cavity 1100 of the nail 1000.

Referring to fig. 13 and 15, in a further embodiment, the pressing assembly 6000 includes a clamping head 6100 and a pushing rod 6200, the clamping head 6100 includes an upper clamping piece 6110, a lower clamping piece 6120 and a clamping piece connecting portion 6130 connected between a proximal end of the upper clamping piece 6110 and a proximal end of the lower clamping piece 6120, and the locking nail 1000 is accommodated between the upper clamping piece 6110 and the lower clamping piece 6120. The proximal end of the push rod 6200 is connected with the distal end of the mandrel 7000, the distal end of the push rod 7000 is disposed close to the upper clip 6120, the mandrel 7000 drives the push rod 6200 to move towards the upper clip 6110, and further pushes the upper clip 6110 to move towards the lower clip 6120, so that the upper clip 6110 and the lower clip 6120 press and hold the locking nail 1000 together.

It can be understood that the upper jaw 6110 and/or the lower jaw 6120 are made of deformable material at least partially, and have a certain elasticity, so that when the upper jaw 6110 and/or the lower jaw 6120 are acted by external force, the deformable upper jaw 6110 and/or the lower jaw 6120 can get close to each other, and the locking nail 1000 placed between the upper jaw 6110 and the lower jaw 6120 is pressed and held into a shape with a certain curvature. It is understood that the upper jaw 6110 and the lower jaw 6120 are preferably made of stainless steel, nitinol, cobalt-chromium alloy, etc., and the jaw connecting portion 6130 is made of stainless steel, nitinol, etc., in this embodiment, the entire clamp 6100 is made of nitinol.

Continuing to refer to fig. 13, in a further embodiment, the upper clip 6110 includes a first surface 6111 facing the locking nail 1000, the lower clip 6120 includes a second surface 6121 facing the locking nail 1000, the first surface 6111 is provided with a first engagement portion 6112, the second surface 6121 is provided with a second engagement portion 6122, and the first engagement portion 6112 and the second engagement portion 6122 are adapted to close the upper clip 6110 and the lower clip 6120. It is understood that the first and second engagement portions 6112, 6122 may have a curvature shape or a sawtooth shape that match each other.

When the distal end of the locking pin 1000 is provided with the circular truncated cone 1200 (see fig. 12), the diameter of the circular truncated cone 1200 is larger than the diameter of the proximal portion of the locking pin 1000. To accommodate the staple 1000 having the rounded table 1200, in a further embodiment, the upper jaw 6110 and the lower jaw 6120 have different axial lengths. Preferably, the difference between the axial directions of the upper clamping piece 6110 and the lower clamping piece 6120 is a preset length. The preset length is at least equal to the thickness of the circular truncated cone 1200. Thus, the rounded table 1200 portion of the unclamped lock pin 1000 and the collet 6100 may be placed at the distal end of the outer tube 2000 at the same time and without affecting the tube size of the outer tube 2000. The thickness of the circular truncated cone 1200 refers to the length of the circular truncated cone 1200 along the axial direction of the lock pin 1000.

In a further embodiment, the distal end of the push rod 6200 comprises a first inclined surface 6210, the first inclined surface 6210 being inclined downwardly from the distal end in a proximal direction. The upper clip 6110 includes a second inclined surface 6113 facing away from the locking nail 1000, and the second inclined surface 6113 is inclined downward from the distal end to the proximal end to ensure a larger contact area between the clamp 6100 and the push rod 6200. Preferably, the inclination of the first inclined surface 6210 is smaller than the inclination of the second inclined surface 6113, the inclination of the first inclined surface 6210 is an included angle between the first inclined surface 6210 and the push rod 6200 in a direction from the distal end to the proximal end, and the inclination of the second inclined surface 6113 is an included angle between the second inclined surface 6113 and the push rod 6200 in a direction from the distal end to the proximal end, so that in the process that the push rod 6200 advances toward the distal end, the first inclined surface 6210 at the distal end of the push rod 6200 can continuously press the second inclined surface 6113 of the upper clamping piece 6110, so that the upper clamping piece 6110 gradually approaches the lower clamping piece 6120, and the locking nail 1000 is continuously deformed until the locking nail 1000 cannot be deformed again, and at this time, the locking nail 1000 and the suture line 5000 are firmly fixed together. Push rod 6200 is made of stainless steel, nickel titanium alloy, or cobalt chromium alloy, preferably stainless steel.

It will be appreciated that the distal end of the push rod 6210 and the proximal end of the push rod 6210 form an L-shape. That is, the radial thickness of the distal end of the push rod 6210 is smaller than the radial thickness of the proximal end of the push rod 6210, and the distal end of the push rod 6210 is located at one side of the whole push rod 6210, so that the distal end of the push rod 6210 and the proximal end of the push rod 6210 form an L-shape. When the pushing rod 6200 is pushed forward and presses the collet 6100 downward, the L-shaped pushing rod 6200 causes the collet 6100 to be placed between the L-shapes in the pressing state, so that the difference between the overall thickness of the pushing rod 6200 after pressing the collet 6100 and the thickness of the collet 6100 before pressing is smaller, thereby avoiding affecting the size of the outer tube 2000.

It is understood that the push rod 6210 may be a hollow tubular or solid rod-like structure.

Please refer to fig. 14 and 15, wherein fig. 15 is a partial enlarged view of b in fig. 14 at C. In a further embodiment, the distal end of the outer tube 2000 is provided with a suture inlet 2200 in the radial direction, the diameter of the suture inlet 2200 being at least equal to the diameter of the place where the outer diameter of the locking nail 1000 is largest. To facilitate disengagement of the crimped lock pin 1000 from the distal end of the outer tube 2000. The outer tube 2000 is further provided with a suture outlet 2300, and the suture inlet 2200 and the suture outlet 2300 are both communicated with the hollow inner cavity 1100 of the locking nail 1000. So that the proximal end of the suture 5000 sequentially passes through the suture inlet 2200, the proximal end of the locking nail 1000 and the suture outlet 2300. It is understood that in other embodiments, the suture exit 2300 may be disposed anywhere along the body of the outer tube 2000 or on the handle 3000, so long as the suture exit 2300 is in communication with the hollow lumen 1100 of the staple 1000, thereby allowing the proximal end of the suture 5000 to exit the suture exit 2300.

In a further embodiment, the distal end of the outer tube 2000 comprises a retaining portion 2400, the diameter of the retaining portion 2400 decreasing from the proximal end to the distal end. The holding portion 2400 serves to prevent the locking pin 1000 from falling off from the distal end of the outer tube 2000 before crimping. The diameter of the holding portion 2400 is gradually reduced from the proximal end to the distal end, which is beneficial for the distal end of the outer tube 2000 to enter the patient and smoothly pass through the patient.

referring to fig. 16, in a further embodiment, the retaining portion 2400 includes a distally-located retaining portion end face 2410. The holding portion 2400 is provided with an opening 2420 axially penetrating the holding portion end surface 2410, and the opening 2420 is communicated with the cavity 2100. The opening 2420 is the suture inlet 2200.

In a further embodiment, the opening 2420 is provided with a protrusion 2430 (see a view of fig. 15) along the radial direction, the protrusion 2430 is spaced from the end face 2410 of the holding part by a predetermined distance, and a part of the lock pin 1000 is disposed in the opening 2420, so that the protrusion 2430 fixes the lock pin 1000.

Referring to fig. 16 a, b, 15 and 11, in a further embodiment, the distal end of the locking pin 1000 is provided with a circular truncated cone 1200, the diameter of the circular truncated cone 1200 is larger than the diameter of the proximal portion of the locking pin 1000, the circular truncated cone 1200 is disposed in the opening 2420, and the protrusion 2430 fixes the locking pin 1000 to prevent the locking pin 1000 from falling off from the distal end of the outer tube 2000. The rounded platform 1200 also allows for a smooth transition between the hollow lumen 1100 of the staple 1000 and the distal end of the staple 1000 as possible, avoiding the junction between the two cutting sutures or scratching internal tissues of the patient's body. It will be appreciated that the predetermined distance is at least the thickness of the circular truncated cone 1200, such that the circular truncated cone 1200 is disposed between the protrusion 2430 and the retaining portion end face 2410, which is beneficial for stabilizing the lock pin 1000.

Referring to fig. 11, in a further embodiment, the circular truncated cone 1200 includes an inner side surface 1210, and the inner side surface 1210 is an arc-shaped curved surface. So that the suture 5000 can smoothly pass through the locking nail 1000, and the locking nail 1000 is prevented from cutting the suture 5000 or damaging human tissues.

In a further embodiment, the outer tube 2000 and the mandrel 7000 may be made of metal materials such as stainless steel, nickel titanium, and pure titanium, or polymer materials such as ABS, PS, and PEEK, which may be the same or different. Preferably stainless steel.

In a further embodiment, the locking pin 1000 is made of stainless steel, pure titanium, nickel titanium, cobalt chromium alloy, etc., preferably pure titanium, stainless steel.

In use of the adjustable suture locking device 100 of the first embodiment, an operator first threads out the proximal end of the suture 5000 through the suture inlet 2200 at the distal end of the outer tube 2000, the distal opening of the locking nail 1000 and the suture outlet 2300 at the distal end of the outer tube 2000, the suture 5000 is then secured to the suture securing portion 4110 of the suture restraint 4100, and the length of the suture 5000 is adjusted as desired by the adjustment device 4000, when adjustment is complete, movable portion 3200 of drive handle 3000 moves toward stationary portion 3100, thereby driving mandrel 7000 to move distally relative to outer tube 2000, thereby causing the pushing rod 6200 to squeeze the clamp 6100, the upper clamp 6110 and the lower clamp 6120 of the clamp 6100 to press the locking nail 1000, thereby deforming the nail 1000 (see fig. 15, a in fig. 15 is before crimping, and b is after crimping), and fixing the suture 5000 threaded in the nail 1000 with the nail 1000.

When the adjustable suture locking device 100 is used for mitral valve repair, an operator can adjust the gap between the anterior leaflet and the posterior leaflet of the mitral valve before pressing the locking nail 1000 to fix the suture 5000, and simultaneously observe the backflow condition of the mitral valve through a medical imaging device, and fix the suture 5000 when the backflow condition is the slightest state, thereby realizing the function of adjusting the backflow condition of the mitral valve.

The operation of the adjustable suture locking device 100 of the present invention will now be described in terms of the mitral valve being diseased.

The mitral valve is a one-way "valve" between the Left Atrium (LA) and the Left Ventricle (LV), which ensures blood flow from the left atrium to the left ventricle. A normal healthy mitral valve has a plurality of chordae tendineae. The valve leaves of the mitral valve are divided into an anterior leaf and a posterior leaf, when the left ventricle is in a diastole state, the two are in an opening state, and blood flows from the left atrium to the left ventricle; when the left 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 and posterior leaflets are closed well, thereby ensuring that blood flows from the left ventricle to the aorta through the aortic valve (AV for short). If the mitral valve is diseased, when the left ventricle is in a contracted state, the mitral valve cannot be restored to a closed state as in a normal state, and the impulse of blood further causes the valve leaflets to fall into the left atrium, so that blood backflow is caused. The third embodiment of the present invention provides an adjustable suture locking device 100b that can be used as follows.

The first step is as follows: firstly, a plurality of suture lines 5000 (refer to fig. 17) with elastic gaskets are respectively implanted into the anterior leaflet and the posterior leaflet of the mitral valve, the point contact between the suture lines 5000 and the leaflets is converted into the surface contact between the elastic gaskets and the leaflets, and the risk of tearing the leaflets can be effectively reduced.

The second step is that: the sutures 5000 on both side leaflets are threaded into the staples 1000 of the adjustable suture locking device 100b outside the patient's body, and the proximal ends of the sutures 5000 are threaded out of the suture exits 2300 on the distal body of the outer tube 2000 (see fig. 18), the sutures of the anterior and posterior leaflets are differentiated, the proximal portions of the two sets of sutures 5000 are wound several turns around the spool of a suture holder 4100, and the proximal ends of the sutures 5000 are secured to resilient tabs 4114 to maintain the relative positions of the sutures 5000 and the staples 1000 (see fig. 19). It is understood that in this step, the suture 5000 may also be passed out of the suture exit 2300, and the distal end of the adjustable suture locking device 100b is pushed into the heart through the apex, and moved closer to the leaflets of the mitral valve, and then the suture 5000 is fixed to the resilient tab 4114 (see fig. 20).

The third step: the distal end of the adjustable suture locking device 100b is advanced transapically into the heart, moving closer to the leaflets of the mitral valve, while pulling on the suture 5000 until the distal end of the adjustable suture locking device 100b reaches a predetermined subvalvular position (see fig. 19).

The fourth step: the two adjusting knobs 4500 are respectively rotated to drive the two lead screws 4300 to rotate, so that the wire harness 4100 connected with the lead screws 4300 is driven to move back and forth along the axial direction in the adjusting track 4200, the tightness of the two groups of suture lines 5000 connected with the wire harness 4100 is respectively adjusted, meanwhile, the state of lightest mitral valve regurgitation is determined through ultrasound, and when the state is reached, the adjusting knobs 4500 are stopped rotating, so that the tightness state of the two groups of suture lines 5000 can be maintained, namely the relative distance between the anterior leaflet and the posterior leaflet of the mitral valve is maintained.

The fifth step: referring to fig. 14, 15 and 19, holding the fixed portion 3100 of the handle 3000 stationary, drives the movable portion 3200 towards the fixed portion 3100 until the movable portion 3200 cannot move further, at which time the mandrel 7000 and the pushing rod 6200 move distally relative to the outer tube 2000, and the distal end of the pushing rod 6200 continues to squeeze the collet 6100, such that the upper jaw 6110 and the lower jaw 6120 of the collet 6100 are drawn towards each other, squeezing the locking nail 1000 between the upper jaw 6110 and the lower jaw 6120 until the locking nail 1000 deforms and secures the suture 5000 in the locking nail 1000 together, and the deformed locking nail 1000 is released from the suture entrance 2200 at the distal end of the outer tube 2000 of the adjustable suture locking device 100 b.

And a sixth step: the adjustable suture locking device 100b is withdrawn distally from the patient, the locking pegs 1000 are left in the patient, and the proximal ends of the sutures 5000 are secured to the apex of the heart or papillary muscles, at which time the locking pegs 1000 secure the two sets of sutures 5000 that pass through the anterior leaflet and the posterior leaflet, respectively (see fig. 21), and the anterior leaflet and the posterior leaflet of the mitral valve complete the edge-to-edge repair to form a bi-foraminous structure. It will be appreciated that in this step, the operator may not necessarily fix the proximal end of suture 5000 to the apex of the heart or papillary muscle, but may simply cut the proximal end of suture 5000.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the present invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. An adjustable suture locking device, comprising:

A locking nail for accommodating or fixing a suture;

The locking nail is arranged at the far end of the accommodating cavity;

2. The adjustable suture knot device of claim 1, wherein the adjustment device comprises a cable tie movably connected to the fixation portion, the cable tie being connected to the suture proximal end to adjust the tightening or loosening of the suture.

3. The adjustable suture knot device of claim 2, wherein the adjustment device further comprises an adjustment track disposed on the fixation portion, the cable tie being connected to the fixation portion by the adjustment track; the wire harness advances or retreats on the adjusting track along the axial direction of the adjusting track, so that the tightening or loosening of the suture is adjusted.

4. The adjustable suture knot device of claim 3, wherein the cable harness comprises a suture fixing part and a handle connecting part which are connected with each other, the suture fixing part is detachably connected with the suture, the handle connecting part is arranged in the adjusting track, and the cable harness is advanced or retreated on the adjusting track along the axial direction of the adjusting track through the handle connecting part.

5. The adjustable suture locking device of claim 4, wherein the suture retaining portion comprises a spool and first and second stops connected at opposite ends of the spool, wherein the second stop is distal from the handle attachment portion compared to the first stop.

6. The adjustable suture locking device of claim 5, wherein the suture retaining portion further comprises a spring secured to the second stop portion, the spring configured to retain the suture.

7. The adjustable suture locking device of claim 4, wherein the adjustment track comprises a track cavity and a track outer wall, the handle connecting portion comprises an embedded end and a connecting shaft, the embedded end is located in the track cavity and moves back and forth in the track cavity, the connecting shaft is located on the track outer wall and moves back and forth on the track outer wall, and the embedded end is connected with the suture fixing portion through the connecting shaft.

8. The adjustable suture locking device of claim 7, wherein the track outer wall has first teeth thereon, the connecting shaft has second teeth thereon, and the first teeth and the second teeth are adapted to allow the connecting shaft to roll on the track outer wall.

9. The adjustable suture keying device of claim 4, wherein said adjustment device further comprises a lead screw, a bolt and an adjustment knob, said lead screw is fixed in said fixation portion along an axial direction of said adjustment track, said bolt is fixed in said fixation portion, and said lead screw passes through and fits with said bolt; the proximal end of the lead screw penetrates out of the proximal end of the fixing part and is connected with the adjusting knob; the handle connecting part is fixed on the guide screw rod; the adjusting knob adjusts the lead screw to advance or retreat in the axial direction.

10. The adjustable suture locking device of any one of claims 1-9, wherein the handle further comprises a movable portion, the movable portion and the fixed portion being relatively movable, the locking pin being axially provided with a hollow lumen for receiving and passing the suture; the adjustable suture locking device further comprises:

11. The adjustable suture locking device of claim 10, wherein the crimping assembly comprises a collet and a push rod, the collet comprising an upper jaw, a lower jaw, and a jaw connection connected between a proximal end of the upper jaw and a proximal end of the lower jaw, the locking pin received between the upper jaw and the lower jaw; the near-end of push rod with the distal end of dabber is connected, the distal end of push rod is close to go up the clamping piece setting, the dabber drive the push rod to go up the clamping piece and remove, and then promote go up the clamping piece to lower clamping piece removes so that go up the clamping piece with lower clamping piece is pressed together and is held the staple.

12. The adjustable suture locking device of claim 11, wherein the upper jaw comprises a first surface facing the locking nail, the lower jaw comprises a second surface facing the locking nail, the first surface being provided with a first engagement portion, the second surface being provided with a second engagement portion, the first and second engagement portions being adapted to provide a closure between the upper jaw and the lower jaw.

13. The adjustable suture locking device of claim 11, wherein the distal end of the push rod comprises a first ramp that slopes downward from the distal end to the proximal direction; the upper clamping piece comprises a second inclined surface facing away from the locking nail, and the second inclined surface inclines downwards from the far end to the near end.

14. The adjustable suture locking device of claim 13, wherein the slope of the first slope is less than the slope of the second slope.

15. The adjustable suture locking device of claim 10, wherein the hollow interior comprises opposing upper and lower surfaces, the upper surface having a convex locking ledge and the lower surface having a concave locking aperture, the locking ledge and the locking aperture being adapted to mate.

16. the adjustable suture locking device of claim 10, wherein the distal end of the outer tube is radially provided with a suture inlet having a diameter at least equal to the diameter of the maximum outer diameter of the locking staple; the outer tube is also provided with a suture outlet; the suture line inlet and the suture line outlet are communicated with the hollow inner cavity of the locking nail.

17. The adjustable suture locking device of claim 16, wherein the distal end of the outer tube comprises a retaining portion that gradually decreases in diameter from a proximal end to a distal end.

18. The adjustable suture locking device of claim 17, wherein the retainer comprises a distally located retainer end face; the holding part is provided with an opening which is communicated with the end face of the holding part along the axial direction, and the opening is communicated with the cavity.

19. The adjustable suture locking device of claim 18, wherein the opening is radially provided with a protrusion having a predetermined distance from the end surface of the retaining portion, and a portion of the locking pin is disposed in the opening such that the protrusion secures the locking pin.

20. The adjustable suture knot device of claim 19, wherein the distal end of the staple is provided with a circular truncated cone having a diameter greater than the diameter of the proximal portion of the staple, the circular truncated cone being disposed in the opening, the projection securing the staple.

21. The adjustable suture locking device of claim 20, wherein the rounded table comprises an inner side surface that is arcuately curved.