Adjustable suture locking apparatus

An adjustable suture locking apparatus includes a lock pin, an outer tube, a handle, and an adjusting device. The lock pin is used to receive or fix a suture. The outer tube defines a receiving cavity. The lock pin is disposed at a distal end of the receiving cavity. The handle includes a fixing portion coupled to a proximal end of the outer tube. The adjusting device is disposed on the fixing portion. The adjusting device is coupled to a proximal end of the suture and operable to adjust tensioning or loosening of the suture.

RELATED APPLICATIONS

The present application is a National Phase of International Application Number PCT/CN/2019/087885, filed on May 22, 2019, which claims priority to Chinese Patent Application No. 201810587805.9, filed on Jun. 8, 2018, and Chinese Patent Application No. 201820892356.4, filed on Jun. 8, 2018.

TECHNICAL FIELD

This disclosure belongs to the field of medical appliances, and particularly relates to an adjustable suture locking apparatus.

BACKGROUND

During surgery, an operation step of knotting and fixing sutures is often required. A traditional surgical operation is performed under direct vision, and the sutures may usually be knotted manually by a doctor. However, with the development of technology, various minimally invasive surgeries and interventional surgeries such as an endoscopic surgery and a transcatheter interventional surgery are increasingly becoming common. For these surgeries, patient's body only needs to be incised to form a relatively small incision that acts as an operating window, and through the operating window instruments such as endoscopes or interventional catheters are pushed into the patient's body until the instruments reach a predetermined position to perform treatment. For these surgeries, if the sutures need to be knotted or fixed, the operator usually needs to perform, through the relatively small operating window, a remote operation outside the patient's body to knot the sutures disposed in the patient's body.

In the related art, methods such as a surgical robot, a thread knot pusher, or a transcatheter suture lock implanting system are often used to perform long-distance knotting or fixing of the sutures. However, when these methods are used to lock the sutures, lengths of the sutures cannot be adjusted according to surgical situations and therapeutic effects.

SUMMARY

In view of the above problems, an adjustable suture locking apparatus is provided according to the present disclosure. The detailed technical solution is as follows.

An adjustable suture locking apparatus is provided. The adjustable suture locking apparatus includes a lock pin, an outer tube, a handle, and an adjusting device. The lock pin is operable to receive or fix a suture. The outer tube defines a receiving cavity. The lock pin is disposed at a distal end of the receiving cavity. The handle includes a fixing portion coupled to a proximal end of the outer tube. The adjusting device is disposed on the fixing portion. The adjusting device is coupled to a proximal end of the suture and operable to adjust tensioning or loosening of the suture.

With regard to the adjustable suture locking apparatus provided in the present disclosure, in a minimally invasive surgery or an interventional surgery, according to efficacy, a length of the suture can be timely adjusted in a process of fixing the suture, thereby enhancing a surgical effect and improving a surgery success rate.

DETAILED DESCRIPTION OF ILLUSTRATED IMPLEMENTATIONS

The technical solution in the implementations of the present disclosure will be described clearly and completely hereinafter with reference to the accompanying drawings in the implementations of the present disclosure. Obviously, the described implementations are merely some but not all implementations of the present disclosure. Based on the implementations of the present disclosure, all other implementations obtained by a person of ordinary skill in the art without creative efforts shall fall within the protection scope of the present disclosure.

Orientation definition: an orientation close to an operator is defined as a proximal end, and another orientation away from the operator is defined as a distal end.

As illustrated inFIG.1, an adjustable suture locking apparatus100is provided according to a first implementation of the present disclosure. The adjustable suture locking apparatus100includes a lock pin1000, an outer tube2000, a handle3000, and at least one adjusting device4000. The lock pin1000is used to accommodate or fix the suture5000(referring toFIG.2aor2b, whereinFIG.2aillustrates that the suture5000is not fixed by the lock pin1000, andFIG.2billustrates that the suture5000is fixed by the lock pin1000). The outer tube2000defines a receiving cavity2100, and the lock pin1000is disposed at a distal end of the receiving cavity2100(as illustrated inFIG.15). The handle3000includes a fixing portion3100coupled to a proximal end of the outer tube2000. The adjusting device4000is disposed on the fixing portion3100(as illustrated inFIGS.3a-3c). The adjusting device4000is coupled to the proximal end of the suture5000and used for adjusting tightening or loosening of the suture5000. It can be understood that the adjusting device4000may be any device capable of adjusting the tightening or loosening of the suture5000, such as a bunching device or a buckle. It can be understood that the number of the at least one adjusting device4000can be set according to need. Preferably, two adjusting devices4000are respectively disposed on two opposite sides of the fixing portion3100for adjusting two sets of sutures5000respectively.

With regard to the adjustable suture locking apparatus100provided by the present disclosure, in a minimally invasive surgery or interventional surgery, the adjusting device4000can be used to timely adjust, according to efficacy, the length of the suture5000in a process of fixing the suture5000, thereby enhancing a surgical effect and improving a surgery success rate.

As illustrated inFIGS.3a-3c, in a further implementation, the adjusting device4000includes a bunching device4100movably coupled to the fixing portion3100. The bunching device4100is coupled to the proximal end of the suture5000to adjust the tightening or loosening of the suture5000. By adjusting the tightening or loosening of the suture5000through the bunching device4100, the length of the suture5000can be effectively controlled, and a slight adjustment of the length of the suture5000can be achieved. For example, the suture5000is wound on the bunching device4100, and the suture5000is tightened or loosened by changing a winding direction or a winding manner.

In a further implementation, the adjusting device4000further includes an adjusting rail4200disposed on the fixing portion3100. The bunching device4100is coupled to the fixing portion3100via the adjusting rail4200. The bunching device4100can slide back and forth on the adjusting rail4200along an axial direction of the adjusting rail4200, thereby adjusting the tightening or loosening of the suture5000. It is to be understood that the bunching device4100adjusts the tightening or loosening of the suture5000when rolling on the adjusting rail4200. It is to be understood that the axial direction of the adjusting rail4200coincides with the axial direction of the whole adjustable suture locking apparatus100, or the axial direction of the adjusting rail4200and the axial direction of the whole adjustable suture locking apparatus100define an angle of preset degrees, so as to allow the bunching device4100to roll on the adjusting rail4200, thereby adjusting the tightening or loosening of the suture5000. The axial direction of the whole adjustable suture locking apparatus100refers to a direction from the proximal end to the distal end.

As illustrated inFIGS.4a-4bandFIGS.3a-3c, in a further implementation, the bunching device4100includes a suture fixation4110and a handle connecting portion4120coupled with the suture fixation4110. The suture fixation4110is detachably coupled to the suture5000. The suture5000can be fixed to the suture fixation4110by winding, pressing, fastening, or the like. The handle connecting portion4120is disposed in the adjusting rail4200(as illustrated inFIG.6). The bunching device4100can move back and forth on the adjusting rail4200along the axial direction of the adjusting rail4200via the handle connecting portion4120. The handle connecting portion4120is disposed in the adjusting rail4200by snapping or the like to ensure that the bunching device4100cannot slip off the handle3000.

As illustrated inFIG.4b, in a further implementation, the suture fixation4110includes a spool4111, a first blocking portion4112, and a second blocking portion4113. The first blocking portion4112and the second blocking portion4113are respectively coupled to two opposite ends of the spool4111. The second blocking portion4113is further away from the handle connecting portion4120than the first blocking portion4112. When the suture5000is wound on the spool4111, the first blocking portion4112and the second blocking portion4113at two ends of the spool4111can effectively prevent the suture5000from slipping off the spool4111. It is to be understood that the first blocking portion4112and the second blocking portion4113each have a larger diameter than the spool4111.

Referring toFIG.4a, in a further implementation, the suture fixation4110further includes an elastic sheet4114. The elastic sheet4114is fixed to the second blocking portion4113. The elastic sheet4114is used to fix the suture5000. Referring toFIG.5, it is to be understood that the second blocking portion4113defines an elastic sheet receiving groove4115. The elastic sheet4114is received in the elastic sheet receiving groove4115. After the suture5000is wound on the spool4111several times, the proximal end of the suture5000is fixed to the elastic sheet4114and received in the elastic sheet receiving groove4115to fix the proximal end of the suture5000to the bunching device4100. It can be understood that the elastic sheet receiving groove4115may be designed to be in a shape of a corner, and the elastic sheet4114is designed to be adapted to the elastic sheet receiving groove4115having the shape of a corner. With setting of the shape of a corner, the suture5000cannot easily slip off the elastic sheet4114and is stably fixed.

As illustrated inFIGS.3a-3candFIG.6,FIG.6is an enlarged view of a portion A ofFIG.3c. In a further implementation, the adjusting rail4200defines a rail cavity4210and has a rail outer wall4220. The handle connecting portion4120includes an inserting end4121and a connecting shaft4122. The inserting end4121is disposed in the rail cavity4210and can move back and forth in the rail cavity4210. The connecting shaft4122is disposed on the rail outer wall4220and can move back and forth on the rail outer wall4220. The inserting end4121is fixed to the suture fixation4110via the connecting shaft4122. The inserting end4121is disposed in the rail cavity4210, and movement of the inserting end4121is limited to be within the rail cavity4210due to the rail outer wall4220, and thus the inserting end4121cannot easily slip off the rail cavity4210.

As illustrated inFIGS.7a-7bandFIG.8, an adjustable suture locking apparatus100aaccording to a second implementation of the present disclosure is illustrated.FIG.7ais a right view of the adjustable suture locking apparatus100a, where a handle of the suture locking apparatus100ais viewed.FIG.7bis a cross-sectional view of the adjustable suture locking apparatus100aillustrated inFIG.7a, taken along line B-B.FIG.8is an enlarged view of a portion B ofFIG.7b. The adjustable suture locking apparatus100adiffers from the adjustable suture locking apparatus100in the first implementation in that the adjustable suture locking apparatus100ais provided with first teeth4221on the rail outer wall4220and second teeth4123on the connecting shaft4122. The first teeth4221can be engaged with the second teeth4123to enable the connecting shaft4122to roll on the rail outer wall4220, thereby driving the bunching device4100to move back and forth on the adjusting rail4200along the axial direction of the adjusting rail4200. When the operator rotates the bunching device4100, the bunching device4100moves along the axial direction of the adjusting rail4200, and a rotational motion of the bunching device4100can be converted into a linear motion of the suture5000, thereby accurately achieving the tightening and loosening of the suture5000.

As illustrated inFIGS.9-10, an adjustable suture locking apparatus100baccording to a third implementation is illustrated. The adjustable suture locking apparatus100bdiffers from the adjustable suture locking apparatus100in the first implementation in that the adjusting device4000further includes a lead screw4300, a bolt4400, and an adjusting knob4500. The lead screw4300is fixed in the fixing portion3100along the axial direction of the adjusting rail4200. The bolt4400is fixed in the fixing portion3100, and the lead screw4300passes through the bolt4400and is engaged with the bolt4400. A proximal end of the lead screw4300passes through the proximal end of the fixing portion3100and is coupled to the adjusting knob4500. The handle connecting portion4120is fixed to the lead screw4300. The adjusting knob4500can adjust an axially forward or backward movement of the lead screw4300. When the operator rotates the adjusting knob4500, the adjusting knob4500drives the lead screw4300to rotate in the fixing portion3100, thereby driving the bunching device4100coupled to the lead screw4300to move back and forth on the adjusting rail4200along the axial direction of the adjusting rail4200.

Referring back toFIG.1, in a further implementation, the handle3000further includes a movable portion3200. The movable portion3200can move with respect to the fixing portion3100. The lock pin1000defines a hollow inner cavity1100in the axial direction of the lock pin1000(as illustrated inFIG.11). The hollow inner cavity1100is used to receive the suture5000and allow the suture5000to pass through. The adjustable suture locking apparatus100further includes a squeezing assembly6000and a mandrel7000. The squeezing assembly6000is used to hold and press the lock pin1000to deform the lock pin1000(referring toFIGS.2a-2b, whereinFIG.2aillustrates the lock pin un-deformed, andFIG.2billustrates the lock pin deformed). When the lock pin1000is subjected to a mechanical external force, the lock pin1000can be flattened to fix the suture5000in the lock pin1000, and no relative movement occurs between the suture5000and the lock pin1000, thereby locking and fixing the suture5000. The lock pin1000may be of various shapes, for example, may be in the shape of a cylinder, a prism, or the like. As long as the lock pin1000defines the hollow inner cavity1100for accommodating the suture5000, the lock pin1000may be of any shape. In this implementation, the lock pin1000is in the shape of a cylinder to reduce a squeezing resistance.

A distal end of the mandrel7000is coupled to a proximal end of the squeezing assembly6000, and a proximal end of the mandrel7000is movably coupled to the movable portion3200. The squeezing assembly6000and the mandrel7000are both received in the receiving cavity2100, and the movable portion3200can move relative to the fixing portion3100to move the mandrel7000, so as to cause the squeezing assembly6000to hold and press the lock pin1000. It can be understood that the mandrel7000applies a force to the squeezing assembly6000during the movement of the mandrel7000, so that the squeezing assembly6000can apply a mechanical external force to hold and press the lock pin1000. The mandrel7000can extend to the fixing portion3100, and a movable connecting portion3210between the movable portion3200and the mandrel7000is disposed in the fixing portion3100(as illustrated inFIGS.14a-14b).

As illustrated inFIG.12, in a further implementation, the hollow inner cavity1100of the lock pin1000has an upper surface1110and a lower surface1120opposite the upper surface1110. A lock pad1111protrudes from the upper surface1110, the lower surface1120defines a concave lock hole1121, and the lock pad1111is adapted to the lock hole1121. It can be understood that the upper surface and the lower surface are named when the lock pin1000is placed horizontally, and when the lock pin1000is placed vertically, the upper surface and the lower surface may also be called a left surface and a right surface. When the lock pin1000is deformed by an external squeezing force, the convex lock pad1111is pressed into the concave lock hole1121. When the lock pin1000is further deformed, the lock pad1111and the lock hole1121are both deformed until the lock pad1111and the lock hole1121cannot be separated from each other. At this point, the suture5000is firmly fixed in the hollow inner cavity1100of the lock pin1000.

As illustrated inFIG.13andFIGS.15a-15b, in a further implementation, the squeezing assembly6000includes a collet6100and a pushing rod6200. The collet6100includes an upper clip6110, a lower clip6120, and a clip connecting portion6130coupled between a proximal end of the upper clip6110and a proximal end of the lower clip6120. The lock pin1000is disposed between the upper clip6110and the lower clip6120. A proximal end of the pushing rod6200is coupled to the distal end of the mandrel7000. A distal end of the pushing rod6200is close to the upper clip6110. The mandrel7000drives the pushing rod6200to move toward the upper clip6110, thereby driving the upper clip6110to move toward the lower clip6120to make the upper clip6110and the lower clip6120cooperatively hold and press the lock pin1000.

It is to be understood that, the upper clip6110and/or the lower clip6120are/is at least partially made from a deformable material and have/has certain elasticity. Therefore, when the upper clip6110and/or the lower clip6120are/is subjected to an external force, the deformable upper clip6110and/or the deformable lower clip6120may be driven to be close to each other, so as to hold and press the lock pin1000disposed between the upper clip6110and the lower clip6120to form a shape with a certain curvature. It can be understood that the upper clip6110and the lower clip6120are preferably made of stainless steel, nickel titanium alloy, cobalt chromium alloy or the like, and the clip connecting portion6130is made of stainless steel, nickel titanium alloy or the like. In this implementation, the whole collet6100is made of nickel-titanium alloy.

Still referring toFIG.13, in a further implementation, the upper clip6110has a first surface6111that faces the lock pin1000, and the lower clip6120has a second surface6121that faces the lock pin1000. A first engaging portion6112is formed on the first surface6111, a second engaging portion6122is formed on the second surface6121, and the first engaging portion6112can be engaged with the second engaging portion6122to enable the upper clip6110and the lower clip6120to be in a close state. It can be understood that the first engaging portion6112and the second engaging portion6122each may have a curvature shape or a sawtooth shape and can cooperate with each other.

When the lock pin1000is provided with a circular cone1200at the distal end thereof (seeFIG.12), the diameter of the circular cone1200is larger than that of the proximal end of the lock pin1000. In order to cooperate with the lock pin1000with the circular cone1200, in a further implementation, axial lengths of the upper clip6110and the lower clip6120are different from each other. Preferably, a difference between the axial length of the upper clip6110and the axial length of the lower clip6120equals a preset length. The preset length is at least equal to the thickness of the circular cone1200. Thus, the circular cone1200of the lock pin1000non-pressed and the collet6100can be both placed at the distal end of the outer tube2000without affecting a size of the outer tube2000. The thickness of the circular cone1200refers to the length of the circular cone1200along the axial direction of the lock pin1000.

In a further implementation, the distal end of the pushing rod6200has a first inclined surface6210, and the first inclined surface6210is inclined downwardly along a direction from the distal end to the proximal end. The upper clip6110has a second inclined surface6113that faces away from the lock pin1000, and the second inclined surface6113is inclined downwardly along a direction from the distal end to the proximal end to ensure that there is a relatively large contact area between the collet6100and the pushing rod6200. Preferably, a slope of the first inclined surface6210is smaller than that of the second inclined surface6113. The slope of the first inclined surface6210refers to an included angle defined between the first inclined surface6210and a direction from the distal end of the pushing rod6200to the proximal end of the pushing rod6200, and the slope of the second inclined surface6113refers to an included angle defined between the second inclined surface6113and a direction from the distal end of the pushing rod6200to the proximal end of the pushing rod6200, and thus during that the pushing rod6200is moved toward the distal end, the first inclined surface6210at the distal end of the pushing rod6200can continuously squeeze the second inclined surface6113of the upper clip6110, so that the upper clip6110gradually gets close to the lower clip6120, thereby continuously deforming the lock pin1000until the lock pin1000can no longer be deformed. At this point, the lock pin1000and the suture5000are firmly fixed together. The pushing rod6200is made of stainless steel, nickel-titanium alloy, or cobalt-chromium alloy, and is preferably made of stainless steel.

It can be understood that the distal end of the pushing rod6200and the proximal end of the pushing rod6200form an L-shaped structure, that is, a radial thickness of the distal end of the pushing rod6200is smaller than that of the proximal end of the pushing rod6200, and the distal end of the pushing rod6200is at one side of the whole pushing rod6200, such that the distal end of the pushing rod6200and the proximal end of the pushing rod6200form the L-shaped structure. When the pushing rod6200is advanced to hold and press the collet6100downwardly, the L-shaped pushing rod6200enables the collet6100in the pressed state to be disposed in the L-shaped structure, such that a difference between a thickness of the whole structure formed by the pushing rod6200when the collet6100is pressed and a thickness of the collet6100non-pressed is relatively small, thereby not affecting the size of the outer tube2000.

It can be understood that the pushing rod6200may be a hollow tube or have a solid rod-like structure.

Referring toFIGS.14a-14b,FIG.15a,FIG.15b,FIG.15ais a schematic view illustrating that the lock pin is not held and pressed by the adjustable suture locking apparatus, andFIG.15bis a schematic view illustrating that the lock pin is held and pressed by the adjustable suture locking apparatus, whereinFIG.15ais an enlarged view of a portion C ofFIG.14b. In a further implementation, the distal end of the outer tube2000defines a suture inlet2200along the radial direction of the outer tube2000. A diameter of the suture inlet2200is at least equal to the diameter of a portion of the lock pin1000, where the portion of the lock pin1000has a maximum outer diameter, and thus the lock pin1000pressed can slip off the distal end of the outer tube2000. The outer tube2000further defines a suture outlet2300. The suture inlet2200and the suture outlet2300communicate with the hollow inner cavity1100of the lock pin1000, respectively, so that the proximal end of the suture5000can sequentially pass through the suture inlet2200, the proximal end of the lock pin1000, and the suture outlet2300. It can be understood that, in other implementations, the suture outlet2300may be in any position of the outer tube2000or in the handle3000, as long as the suture outlet2300communicates with the hollow inner cavity1100of the lock pin1000, i.e., the proximal end of the suture5000can pass through the suture outlet2300.

In a further implementation, the outer tube2000is provided with a holding portion2400at the distal end thereof, and the diameter of the holding portion2400gradually decreases from the proximal end to the distal end. The holding portion2400is used to prevent the lock pin1000non-pressed from slipping off the distal end of the outer tube2000. The diameter of the holding portion2400gradually reduces from the proximal end to the distal end, thereby facilitating driving the distal end of the outer tube2000to enter the patient's body and smoothly move in the body.

As illustrated inFIGS.16aand16b, in a further implementation, the holding portion2400has a holding portion end surface2410at the distal end thereof. The holding portion2400defines an opening2420in the axial direction of the holding portion2400, and the opening2420extends through the holding portion end surface2410and communicates with the receiving cavity2100. The opening2420is the suture inlet2200.

In a further implementation, a protrusion2430is formed at the opening2420in a radial direction of the opening2420(seeFIG.15a). A preset distance exists between the protrusion2430and the holding portion end surface2410. The lock pin1000is partially disposed in the opening2420, so that the protrusion2430can fix the lock pin1000.

As illustrated inFIG.16a,FIG.16b,FIG.15a,FIG.15b, andFIG.11, in a further implementation, the lock pin1000is provided with the circular cone1200at the distal end thereof. The diameter of the circular cone1200is larger than that of the proximal end of the lock pin1000, and the circular cone1200is disposed in the opening2420. The protrusion2430fixes the lock pin1000, thereby preventing the lock pin1000from slipping off the distal end of the outer tube2000. With the circular cone1200, the transition between the hollow inner cavity1100of the lock pin1000and the distal end of the lock pin1000is enabled to be smooth to the greatest extent, thereby preventing a connection portion between the hollow inner cavity1100and the distal end of the lock pin1000from cutting off the suture5000or scratching internal tissues of the patient's body. It can be understood that the preset distance is at least equal to the thickness of the circular cone1200, so that the circular cone1200is arranged between the protrusion2430and the holding portion end surface2410, thereby facilitating stability of the lock pin1000.

As illustrated inFIG.11, in a further implementation, the circular cone1200has an inner sidewall1210that is an arc-shaped surface, such that the suture5000can smoothly pass through the lock pin1000, thereby preventing the lock pin1000from cutting off the suture5000or damaging human tissues.

In a further implementation, the outer tube2000and the mandrel7000may both be manufactured by processing a metal material such as stainless steel, nickel titanium, pure titanium or the like, or can be manufactured by processing a polymer material such as acrylonitrile butadiene styrene (ABS), polystyrene (PS), polyether ether ketone (PEEK), or the like. The outer tube2000and the mandrel7000may be made from the same material or different materials. The outer tube2000and the mandrel7000may be preferably made of stainless steel.

In a further implementation, the lock pin1000is made of stainless steel, pure titanium, nickel titanium, cobalt chromium alloy, or the like, and preferably made of pure titanium or stainless steel.

When using the adjustable suture locking apparatus100provided in the first implementation, the operator first enables the proximal end of the suture5000to sequentially pass through the suture inlet2200on the distal end of the outer tube2000, the opening on the distal end of the lock pin1000, and the suture outlet2300on the distal end of the outer tube2000, and then enables the suture5000to be fixed to the suture fixation4110of the bunching device4100. The length of the suture5000is then adjusted by the adjusting device4000according to need. After adjustment, the movable portion3200of the handle3000is driven to move toward the fixing portion3100, so as to drive the mandrel7000to move toward the distal end with respect to the outer tube2000, thereby causing the pushing rod6200to hold and press the collet6100. The upper clip6110and the lower clip6120of the collet6100hold and press the lock pin1000to deform the lock pin1000(Refer toFIG.15aandFIG.15b, whereinFIG.15aillustrates the lock pin1000non-pressed, andFIG.15billustrates the lock pin1000pressed), and then the suture5000received in the lock pin1000is fixed to the lock pin1000.

When the adjustable suture locking apparatus100in the present disclosure is used for repairing the leaflets of the mitral valve, before the lock pin1000is held and pressed to fix the suture5000, the operator can adjust a gap between the anterior leaflet and the posterior leaflet of the mitral valve. Meanwhile, the mitral regurgitation is observed through a medical imaging device. When the mitral regurgitation becomes slightest, the suture5000is fixed, thereby realizing a function of adjusting the mitral regurgitation.

The following will illustrate an operation process of the adjustable suture locking apparatus in the present disclosure by taking the mitral valve that has lesions as an example.

The mitral valve is a one-way “valve” between a left atrium (LA for short) and a left ventricle (LV for short) and can ensure blood flow from the left atrium to the left ventricle. The mitral valve in a health state has chordae tendineae. The mitral valve includes two leaflets, i.e., an anterior leaflet and a posterior leaflet. When the left ventricle is in a diastolic state, the anterior leaflet and the posterior leaflet are in an open state, and the blood flows from the left atrium to the left ventricle. When the left ventricle is in a contracted state, the chordae tendineae are stretched to prevent the leaflets from being washed by the blood flow to the left atrium, and the anterior leaflet and the posterior leaflet are in a good close state to ensure blood flow from the left ventricle to an aorta through an aortic valve (AV for short). Different from the mitral valve in the health state, under the condition that the mitral valve has lesions, the mitral valve cannot return to the close state when the left ventricle is in the contracted state, and the momentum of the blood flow can further cause the leaflet to fall into the left atrium, thereby resulting in blood regurgitation. A usage process of the adjustable suture locking apparatus100bprovided by the third implementation of the present disclosure is as follows.

At the first step, multiple sutures5000with elastic pads are first implanted into both the anterior leaflet and the posterior leaflet of the mitral valve (seeFIG.17). A point contact between the suture5000and the leaflet is changed to a surface contact between the elastic pad and the leaflet, thereby effectively reducing a risk of tearing the leaflet.

At the second step, outside the patient's body, the multiple sutures5000in both the leaflets are all inserted into the lock pin1000of the adjustable suture locking apparatus100b, and the proximal ends of the sutures5000are enabled to pass through the suture outlet2300on the distal body of the outer tube2000(seeFIG.18). The sutures in the anterior leaflet and posterior leaflet are distinguished, and the proximal ends of the two sets of sutures5000are respectively wound on the spools of the bunching devices4100several times, and then the proximal ends of the sutures5000are fixed to the elastic sheets4114to maintain the relative position between the sutures5000and the lock pin1000(seeFIG.19). It is to be understood that, at this step, after the sutures5000pass through the suture outlet2300, the distal end of the adjustable suture locking apparatus100bcan be first pushed into the heart through the apex of the heart and is moved to be close to the leaflet of the mitral valve, and then the sutures5000are fixed to the elastic sheet4114respectively (seeFIG.20).

At the third step, the distal end of the adjustable suture locking apparatus100bis pushed into the heart through the apex of the heart and is moved to be close to the leaflet of the mitral valve, meanwhile, the sutures5000are pulled, until the distal end of the adjustable suture locking apparatus100breaches a predetermined position that is below the leaflet (seeFIG.19).

At the forth step, the two adjusting knobs4500are rotated respectively to drive the two lead screws4300to rotate, thereby driving each bunching device4100connected to one lead screw4300to move back and forth on the adjusting rail4200along the axis direction of the adjusting rail4200, so as to adjust the tightness of the two sets of sutures5000coupled to the bunching devices4100respectively, and determine, by ultrasound, a state in which the mitral regurgitation is slightest. When the state reaches, the rotation of the adjusting knobs4500are stopped to maintain the tightness of the two sets of sutures5000, that is, to maintain a relative distance between the anterior leaflet and the posterior leaflet.

At the fifth step, as illustrated inFIG.14a,FIG.14b,FIG.15a,FIG.15b, andFIG.19, the fixing portion3100of the handle3000remains unchanged, and the movable portion3200is driven to move toward the fixing portion3100until the movable portion3200cannot be further moved. At this point, the mandrel7000and the pushing rod6200move toward the distal end with respect to the outer tube2000. The distal end of the pushing rod6200continuously squeezes the collet6100, so that the upper clip6110and the lower clip6120of the collet6100get close to each other to hold and press the lock pin1000between the upper clip6110and the lower clip6120, until the lock pin1000is deformed and the sutures5000in the lock pin1000are fixed together. The deformed lock pin1000slips off the suture inlet2200on the distal end of the outer tube2000of the adjustable suture locking apparatus100b.

At the sixth step, the distal end of the adjustable suture locking apparatus100bis pulled out of the patient's body, the lock pin1000stays in the patient's body, and the proximal end of the sutures5000is fixed to the apex of the heart or the papillary muscle. At this point, with the lock pin1000, the two sets of sutures5000in the anterior leaflet and the posterior leaflet are fixed together (seeFIG.21), and edge-to-edge repair for the anterior leaflet and the posterior leaflet of the mitral valve is completed, thereby forming a dual-bore structure. It can be understood that, at this step, the operator does not need to fix the proximal end of the suture5000to the apex of the heart or the papillary muscle, and what is needed is to snip the proximal end of the sutures5000.

The implementations of the present disclosure are described in detail above, and specific examples are used to explain the principles and implementations of the present disclosure. The illustration of the above implementations is only used to help in understanding the method and the core idea of the present disclosure. Also, according to the ideas of the present disclosure, those of ordinary skill in the art can make changes for specific implementations and application scopes. In summary, the content of this specification should not be construed as limiting the present disclosure.