CN115177405A

CN115177405A - High-elasticity anti-reflux heart valve stent

Info

Publication number: CN115177405A
Application number: CN202210753464.4A
Authority: CN
Inventors: 吴明明; 王春光; 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Koka Nantong Lifesciences Co Ltd
Priority date: 2022-06-28
Filing date: 2022-06-28
Publication date: 2022-10-14

Abstract

The application relates to a high elasticity anti-regurgitation heart valve support, wherein the high elasticity anti-regurgitation heart valve support distal end is including setting up the setting element between adjacent connecting piece, and the nearly heart end of high elasticity anti-regurgitation heart valve support includes screens end, and this screens end includes at least one deck interconnect's rhombus grid cell. The high-elasticity anti-reflux heart valve stent further comprises a reinforcing net, the reinforcing net comprises at least one quadrilateral grid unit which is oval or rhombic when the high-elasticity anti-reflux heart valve stent extends, one end of the reinforcing net is fixedly connected with the connecting piece, and the other end of the reinforcing net is fixedly connected with the far end of the rhombic grid unit. The high-elasticity anti-regurgitation heart valve stent positioning piece is connected with the clamping end through the elastic reinforcing net, when the valve is subjected to aortic blood flow regurgitation pressure, the reinforcing net generates certain deformation, the impact of the positioning piece on the aortic sinus floor is buffered, the injury of the positioning piece on the aortic sinus floor is reduced, and the high-elasticity anti-regurgitation heart valve stent positioning piece is more friendly to users.

Description

High-elasticity anti-regurgitation heart valve stent

Technical Field

The application relates to the technical field of medical equipment, in particular to a high-elasticity anti-reflux heart valve stent.

Background

Because of the advantages of small trauma and rapid recovery associated with transcatheter procedures, more and more procedures are beginning to be performed using transcatheter procedures. Aortic valve replacement was also changed from the early surgical approach to transcatheter aortic valve replacement, and heart valve stents were one of the key instruments for success of transcatheter aortic valve replacement.

A heart valve stent typically includes a heart valve stent proximal end and a heart valve stent distal end. In Chinese patent: the stent (publication number: CN 102413793B) for positioning and anchoring a valvular prosthesis at an implantation site in a heart of a patient indicates an aortic valve stent which is connected between a proximal end and a distal end of the aortic valve stent by using a wide fastening part for better holding a native valve leaflet, but such a design brings a great risk that the valvular stent is subjected to a pressure of blood backflow from an aorta each time a left ventricle is in diastole, and the blood flow drives a positioning part of the stent to rigidly impact the aortic sinus floor, thereby easily causing low sinus injury.

For this reason, there is a continuing need in the art to develop a highly elastic anti-regurgitation heart valve stent.

Disclosure of Invention

The application aims to provide a high-elasticity anti-reflux heart valve stent. Research shows that the regurgitation-resisting heart valve stent does not need to have great clamping force of the native valve leaflets, but needs to be inserted into the non-closed surface of the native valve leaflets, namely the inside of the aortic sinus, and all the traditional stents are designed to have great supporting force in order to keep the shape of the stent, namely the stent has certain strength as a whole, namely the positioning element is in relatively rigid connection with the proximal end of the stent, so that the design brings a significant problem that the positioning element can rigidly impact the aortic sinus floor when the stent bears the regurgitation pressure from the blood flow of the aorta every time, generally one person has about 3600 ten thousand heart beats per year, and therefore the continuous rigid impact of the positioning element on the aortic sinus floor can cause immeasurable damage to the aortic sinus floor and even puncture the aortic sinus floor. Specifically, in the high-elasticity anti-regurgitation heart valve stent described herein, the diamond-shaped mesh with high elasticity is adopted to replace the fastening parts and the reinforcing meshes inside the fastening parts in the common heart valve stent, so that the positioning piece has high elasticity relative to the proximal end of the stent.

In order to solve the above technical problems, the present application provides the following technical solutions.

In a first aspect, the present application provides a high elasticity anti-regurgitation heart valve stent, the high elasticity anti-regurgitation heart valve stent includes high elasticity anti-regurgitation heart valve stent proximal end and high elasticity anti-regurgitation heart valve stent distal end, a serial communication port, the high elasticity anti-regurgitation heart valve stent distal end is including setting up the setting element between adjacent connecting piece, the setting element is used for fixing a position high elasticity anti-regurgitation heart valve stent, the setting element includes first locating arm, second locating arm and connects first locating arm and second locating arm and towards the bellied setting element distal end of high elasticity anti-regurgitation heart valve stent proximal end;

the proximal end of the high-elasticity anti-reflux heart valve stent comprises a clamping end, and the clamping end comprises at least one layer of diamond grid units which are connected with each other;

the high-elasticity anti-reflux heart valve stent further comprises a reinforcing net, the reinforcing net comprises at least one quadrilateral grid unit which is elliptic or rhombic when the high-elasticity anti-reflux heart valve stent is extended, one end of the reinforcing net is fixedly connected with the connecting piece of the high-elasticity anti-reflux heart valve stent, and the other end of the reinforcing net is fixedly connected with the far end of the rhombic grid unit;

the reinforcing mesh and the positioning piece clamp the native valve leaflets together.

In an embodiment of the first aspect, the reinforcing mesh includes a first quadrilateral mesh unit formed by connecting a first connecting rod, a second connecting rod, a third connecting rod and a fourth connecting rod, wherein a proximal end of the first connecting rod is fixedly connected with a distal end of the second connecting rod, and a proximal end of the fourth connecting rod is fixedly connected with a distal end of the third connecting rod;

wherein the distal end fixed connection of first connecting rod and fourth connecting rod is in the connecting piece, the proximal end fixed connection of second connecting rod and third connecting rod is in rhombus net unit's distal end.

In an embodiment of the first aspect, the reinforcing mesh includes a first quadrilateral mesh unit and a second quadrilateral mesh unit, the first quadrilateral mesh unit is formed by connecting a first connecting rod, a second connecting rod, a third connecting rod and a fourth connecting rod, a proximal end of the first connecting rod is fixedly connected with a distal end of the second connecting rod, a proximal end of the fourth connecting rod is fixedly connected with a distal end of the third connecting rod, the second quadrilateral mesh unit is formed by connecting a fifth connecting rod, a sixth connecting rod, a seventh connecting rod and an eighth connecting rod, a proximal end of the fifth connecting rod is fixedly connected with a distal end of the sixth connecting rod, and a proximal end of the eighth connecting rod is fixedly connected with a distal end of the seventh connecting rod;

the connecting piece is fixedly connected with the outer side of the diamond grid unit, and the connecting piece is fixedly connected with the outer side of the diamond grid unit.

In an implementation manner of the first aspect, the reinforcing mesh further includes two third quadrilateral mesh units, the two third quadrilateral mesh units are symmetrically disposed on two sides of the second quadrilateral mesh unit, the third quadrilateral mesh unit is close to one side of the second quadrilateral mesh unit and shares one vertex with the second quadrilateral mesh unit, a proximal end of the third quadrilateral mesh unit is fixedly connected to a distal end of the rhombic mesh unit, and the distal end of the third quadrilateral mesh unit is a free end.

In an embodiment of the first aspect, when the number of the quadrilateral mesh cells is two, the number of the quadrilateral mesh cells increases from the distal end of the high elasticity anti-regurgitation heart valve stent to the proximal end of the high elasticity anti-regurgitation heart valve stent.

In one embodiment of the first aspect, the reinforcing mesh is provided with multiple layers of quadrilateral grid cells, and at least one layer of quadrilateral grid cells is 1.

In one embodiment of the first aspect, the reinforcing mesh has at least three layers of quadrilateral mesh cells, and the number of quadrilateral mesh cells in each layer from the distal end to the proximal end of the reinforcing mesh is not all incremental, but remains partially equal.

In one embodiment of the first aspect, the quadrilateral mesh cells are formed by reinforcing mesh links that are thin in the middle and wide at both ends. The rhombic grid cells are formed by clamping end connecting rods, and the middle of each clamping end connecting rod is thin, and the two ends of each clamping end connecting rod are wide.

In one embodiment of the first aspect, the first positioning arm and the second positioning arm are linear or curved.

In one embodiment of the first aspect, the opening angle of the positioning members is 2 ° to 14 ° when the high elasticity anti-regurgitation heart valve stent is extended.

In one embodiment of the first aspect, the distal end of the positioning member has a parabolic shape.

In one embodiment of the first aspect, a perpendicular distance from a distal end of the positioning member to a distal end of the positioning member end is 2mm to 8mm.

In one embodiment of the first aspect, the distal end of the station end is flared proximally relative to the station end, and the distal end of the station end is flared proximally at an angle of 6 ° to 14 ° relative to the station end.

In an embodiment of the first aspect, the connecting piece includes connecting block, connecting web and connection frame, the one end of connecting block forms anti-regurgitation heart valve support near-end, the other end passes through connecting web with connection frame connects, connection frame's distal end with the distal end fixed connection of first locating arm and second locating arm, just connection frame's proximal end with the distal end fixed connection of quadrangle grid unit.

In one embodiment of the first aspect, the attachment frame includes an elongated suture hole adapted for the prosthetic leaflet to pass through, the elongated suture hole having one end proximate the distal end of the attachment frame and another end proximate the proximal end of the attachment frame.

In one embodiment of the first aspect, the distal end of the highly elastic anti-regurgitation heart valve stent further comprises a support disposed between adjacent connectors, the support being closer to the distal end of the highly elastic anti-regurgitation heart valve stent than the positioning member and being for fixation of native leaflets;

the support comprises a first support arm, a second support arm and a support far end which is connected with the first support arm and the second support arm and faces the high-elasticity anti-reflux heart valve support and is convex at the heart end near the heart.

In an embodiment of the first aspect, the connecting piece includes connecting block, connection web and connection frame, the one end of connecting block forms anti-regurgitation heart valve support near-end, the other end passes through connection web with connection frame connects, connection frame's distal end with the distal end fixed connection of first support arm and second support arm, just connection frame's proximal end with first locating arm, second locating arm and the distal end fixed connection of quadrangle net unit.

Compared with the prior art, the invention has the positive effects that:

1. the high-elasticity anti-reflux heart valve stent positioning piece is connected with the clamping end through the elastic reinforcing net, when the valve is subjected to aortic blood flow reflux pressure, the reinforcing net generates certain deformation, the impact of the positioning piece on the aortic sinus floor is buffered, the damage of the positioning piece on the aortic sinus floor is reduced, and the high-elasticity anti-reflux heart valve stent positioning piece is more friendly to users;

2. the arrangement of the pull-wire composite ring enables the high-elasticity anti-reflux heart valve stent to be positioned and operated more easily.

In addition, the highly elastic anti-regurgitation heart valve stent described herein has the following advantages. The positioning piece and the bracket form a certain opening angle, so that the positioning piece can conveniently capture valve leaflets and reduce the operation difficulty, the natural opening angle of the positioning piece in the unfolding state ranges from 2 degrees to 14 degrees, and in the embodiment with the supporting piece, the opening angle of the supporting piece is smaller than that of the positioning piece. The bottom of the positioning piece is in a parabolic shape, so that the contact stress between the positioning piece and the sinus floor is reduced, and the valve ring is prevented from cracking. The vertical distance from the far end of the positioning piece to the far end of the clamping end is 2mm-8mm, and the preferred size is 6mm;

the far end of the clamping end expands outwards relative to the near end of the clamping end, the angle of the far end of the clamping end expanded outwards relative to the near end of the clamping end is 6-14 degrees, the outward expansion reason needs to be generated, the backflow support is prevented from moving towards the direction of the aorta, the clamping end and the aortic annulus play an anchoring role, and the reason that an overlarge angle cannot be generated is that: the clamping end extending into the heart is prevented from touching the bundle of his so as to influence the normal beating of the heart and endanger life;

the support piece and the connecting piece are connected with the far end of the frame, and the positioning piece is connected with the near end of the connecting frame of the connecting piece, so that the far end of the support piece and the far end of the positioning piece are prevented from forming a scissors structure, and therefore, native valve leaflets are cut, and secondary damage is caused to the native valve leaflets of a human body;

the connecting rods of the quadrilateral grid cells and the rhombic grid cells are still in a form of thin middle part and wide two ends, so that the fatigue resistance of the high-elasticity anti-regurgitation heart valve stent is improved, the resilience of the high-elasticity anti-regurgitation heart valve stent is improved, and the high-elasticity anti-regurgitation heart valve stent is convenient to self-expand.

Drawings

Fig. 1 shows a highly elastic anti-regurgitation heart valve stent according to one embodiment.

Fig. 2 shows a deployment view of the high resilience antireflux heart valve stent of fig. 1.

Fig. 3 shows a highly elastic anti-regurgitation heart valve stent according to another embodiment.

Fig. 4 shows a deployment view of the high resilience antireflux heart valve stent of fig. 3.

Fig. 5 shows a highly elastic anti-regurgitation heart valve stent according to another embodiment.

Fig. 6 shows a deployment view of the high resilience antireflux heart valve stent of fig. 5.

Fig. 7 shows a highly elastic anti-regurgitation heart valve stent according to another embodiment.

Fig. 8 shows a deployment view of the high elastic anti-regurgitation heart valve stent of fig. 7.

Fig. 9 shows a highly elastic anti-regurgitation heart valve stent according to another embodiment.

Fig. 10 shows the highly elastic anti-regurgitation heart valve stent according to fig. 9.

Fig. 11 shows a deployment view of the high elasticity anti-regurgitation heart valve stent according to fig. 9.

Fig. 12 shows a partial enlarged view of the area a in fig. 11.

Fig. 13 shows a partial enlarged view of the region B in fig. 11.

Fig. 14 shows a highly elastic anti-regurgitation heart valve stent according to another embodiment.

Fig. 15 shows a deployment view of the high resilience antireflux heart valve stent of fig. 14.

Fig. 16 shows a deployment view of a high resilience anti-regurgitation heart valve stent according to another embodiment.

Detailed Description

Unless otherwise defined, technical or scientific terms used in the present specification and claims should have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like, indicate orientations or positional relationships based on those shown in the drawings, and are used only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the referenced devices or elements must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be construed as limiting the present invention.

Furthermore, the terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first," "second," etc. may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.

In the description of the present invention, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood by those of ordinary skill in the art through specific situations.

As used herein, when describing the heart valve stent, "proximal" refers to a side of the delivery device or a side in the direction of the user-manipulated end when the heart valve stent assumes an expanded state. Accordingly, "distal" refers to the side of the heart valve stent that is distal from the delivery device or away from the direction of the user-manipulated end when the heart valve stent assumes an expanded state. In the present application, when describing the heart valve stent, "proximal" refers to a side of the heart valve stent that is close to the apex of the heart when the heart valve stent assumes an expanded state. Accordingly, "distal" refers to the side of the heart valve stent that is distal to the apex of the heart when the heart valve stent is in an expanded state. Because the cardiac valve stent described herein is delivered by a catheter through the aorta, the distal end and the proximal end refer to the same location, and the proximal end and the distal end refer to the same location, but this does not exclude transapical implantation, but only the cardiac valve stent is described herein as being delivered by a catheter through the aorta.

The technical solutions of the present application will be clearly and completely described below with reference to the accompanying drawings and embodiments of the present application.

Example 1

The embodiment provides a high elasticity anti-regurgitation heart valve stent, the reinforcing mesh 13 of which comprises a quadrangular lattice cell 131.

Referring to fig. 1, the high elasticity anti-regurgitation heart valve stent of the present embodiment may comprise a high elasticity anti-regurgitation heart valve stent proximal end and a high elasticity anti-regurgitation heart valve stent distal end. The distal end of the highly elastic anti-regurgitation heart valve stent comprises positioning members 12 disposed between adjacent connecting elements 14. The positioning member 12 may be used to position a highly elastic anti-regurgitation heart valve stent. Referring to fig. 2, the positioning member 12 may include a first positioning arm 121, a second positioning arm 122, and a distal positioning member end 123 connecting the first positioning arm 121 and the second positioning arm 122 and protruding toward the proximal end of the highly elastic anti-regurgitation heart valve stent. In this embodiment, the proximal end of the highly elastic anti-regurgitation heart valve stent comprises a retaining end 16, and the retaining end 16 comprises a layer of 18 diamond-shaped grid cells 161 connected to each other.

In this embodiment, the high elasticity heart valve stent against regurgitation further comprises a reinforcing mesh 13, the reinforcing mesh 13 comprises a quadrilateral grid unit 131 which is elliptical or rhombic when the high elasticity heart valve stent against regurgitation is stretched, one end of the reinforcing mesh 13 is fixedly connected with the connecting piece 14 of the high elasticity heart valve stent against regurgitation, the other end is fixedly connected with the distal end of the rhombic grid unit 161, and the quadrilateral grid unit 131 is rich in elasticity in the axial direction.

Next, more details and features of the positioning member 12 of the high elasticity regurgitation resisting heart valve stent of the present embodiment will be described first.

In this embodiment, the positioning member 12 may be used to position a highly elastic anti-regurgitation heart valve stent. The positioning member 12 may include a first positioning arm 121, a second positioning arm 122, and a positioning member distal end 123 connecting the first positioning arm 121 and the second positioning arm 122. The distal end 123 of the positioning member may be raised toward the proximal end of the high elasticity anti-regurgitation heart valve stent. The first positioning arm 121 is fixedly connected to a first connecting member, and the second positioning arm 122 is fixedly connected to a second connecting member, the first connecting member being adjacent to the second connecting member. After the high-elasticity anti-regurgitation heart valve stent is placed at the aortic valve position, the positioning piece 12 and the reinforcing net 13 clamp the native valve leaflets, and the artificial heart valve leaflets in the high-elasticity anti-regurgitation heart valve stent can replace the native valve leaflets to work.

In one embodiment, referring to fig. 2, the first positioning arm 121 and the second positioning arm 122 are linear when the heart valve stent is in a compressed state. The first positioning arm 121 and the second positioning arm 122 are designed to be linear in order to facilitate compression of the high elasticity anti-regurgitation heart valve stent. When the high-elasticity anti-reflux heart valve stent is fully compressed, the occupied space is minimum, and the linear structure can ensure that the high-elasticity anti-reflux heart valve stent and the high-elasticity anti-reflux heart valve stent do not interfere in the compression process. In addition, the high-elasticity anti-reflux heart valve stent can be formed by cutting a nickel-titanium tube, but it needs to be explained here that the adopted material can be any material which can be implanted into a human body, the linear design is also beneficial to processing, the processing path is shortened, and the processing cost is reduced.

In one embodiment, the distal end of the spacer 12 may have a parabolic configuration to reduce the contact stress of the spacer 12 with the sinus floor and prevent rupture of the annulus. In one embodiment, the positioning member 12 has a second opening angle when the highly elastic anti-regurgitation heart valve stent is in the expanded state, said second opening angle being 2 ° to 14 °. For example, the second opening angle can be 4 °, 6 °, 8 °, 10 °, 12 °, etc. The positioning part 12 can be used for preventing the valve from shifting towards the ventricle when the valve is subjected to the reflux pressure of aortic blood flow, so that the distal end of the artificial valve leaflet is always aligned with the distal end of the native valve leaflet, the native valve can be restored to the maximum extent, and the artificial valve can be kept at the position of the original native valve, so that the artificial valve can well replace the native valve, the influence on the blood flow is reduced, the occurrence of thrombus is reduced, the positioning part 12 and the reinforcing mesh 13 can clamp the native valve relatively by the arrangement of the second opening angle of 2-14 degrees, the native valve can be prevented from moving freely, if the opening angle is not set, the positioning part 12 presses the native valve leaflet into the support, the native valve leaflet invades the artificial valve leaflet, the valve operation is affected, and if the second opening angle is too large, the clamping weakening force between the positioning part 12 and the reinforcing mesh 13 can be caused, so that the native valve leaflet can not contact the positioning part 12 and the reinforcing mesh 13 at the same time, the native valve leaflet can not be tightly attached to the support, and the risk of peripheral leakage of the valve can be increased.

In one embodiment, the distal end of the positioning member 12 is positioned closest to the distal end of the heart valve stent at a vertical distance of 2mm to 8mm, preferably 6mm, from the distal-most portion of the heart valve stent (i.e., the capture end 16 described below).

In this embodiment, the highly elastic anti-regurgitation heart valve stent may also include a pull wire composite ring 124. Specifically, the positioning member 12 may include a pull wire composite ring 124, the pull wire composite ring 124 being fixedly attached to the positioning member 12 and located on a side of the positioning member 12 facing the highly elastic anti-regurgitation heart valve stent. The pull wire composite ring 124 may include a first through hole 1241 and a second through hole 1242, the first through hole 1241 is used for mounting a marker, the second through hole 1242 is adapted to pass a pull wire therethrough, and the second through hole 1242 is closer to the proximal end of the heart valve stent than the first through hole 1241. In one embodiment, the first through hole 1241 has a larger aperture than the second through hole 1242. The pull-wire composite ring 124 structure provided at the distal end of the positioning member 12 combines the installation of a pull-wire and a marker "(the marker is radiopaque) into one position, effectively reducing the space occupation of the product. By utilizing one position, the opening and closing control and positioning of the positioning piece 12 can be realized, the compression performance of the product is improved, the product is conveyed by using a guide pipe, and the opening angle of the positioning piece 12 can be controlled, so that the difficulty of the operation is reduced. The stay wire composite ring 124 has two through holes, the big hole is for placing marker points so as to be implanted with accurate positioning, the positioning piece is ensured to touch the sinus floor, the small hole is convenient for penetrating a stay wire, in the implantation process, the stay wire is used for controlling the opening angle of the positioning piece 12, thus being convenient for capturing valve leaflets and reducing the operation difficulty. In a preferred embodiment, the pull-wire composite ring 124 is disposed inside the distal end of the positioning member 12 (the inside is the opening direction of the positioning member 12) and is inclined inward relative to the stent axis, so as to prevent the proximal end of the pull-wire composite ring from colliding with the aortic wall during the shaking of the stent, thereby damaging the aorta, which may seriously cause aortic dissection and threaten the life of the user.

Next, further details and features of the reinforcing mesh 13 will be described.

In this embodiment, the reinforcing mesh 13 may be used to sandwich the native leaflets together with the positioning member 12. In this embodiment, the reinforcing mesh 13 may include one quadrilateral mesh unit 131, and in this embodiment, the reinforcing mesh 13 may include only one first quadrilateral mesh unit 1131, where the first quadrilateral mesh unit 131 is formed by connecting a first link 1301, a second link 1302, a third link 1303 and a fourth link 1304, a proximal end of the first link 1301 is fixedly connected to a distal end of the second link 1302, and a proximal end of the fourth link 1304 is fixedly connected to a distal end of the third link 1303. In this embodiment, the distal ends of the first link 1301 and the fourth link 1304 are fixedly connected to the connecting member 14, the proximal ends of the second link 1302 and the third link 1303 are fixedly connected to the distal ends of the diamond-shaped grid cells 161 of the positioning end 16, after the valve stent is implanted in the aortic valve, the valve stent will bear the regurgitation pressure from the aortic blood, the aortic regurgitation blood will impact the artificial valve leaflets, the distal ends of the artificial valve leaflets are mainly closed and will not bear a great deal of force perpendicular to the stent axis, and the bottom (proximal end) of the artificial valve leaflets is completely sealed to form the blocking surface, so the bottom of the artificial valve leaflets will bear a great force perpendicular to the stent axis, so the bottom (proximal end) of the artificial valve leaflets will bear a great deal of force when impacted by the blood flow, the clamping end 16 is driven to move towards the ventricle direction, the clamping end 16 transmits force to the positioning part 12 through the reinforcing net 13, the positioning part 12 ensures that the clamping end 16 cannot move downwards through the force, the reinforcing net 13 of the stent in the design is composed of the quadrilateral grid unit 131, the first connecting rod 1301 and the second connecting rod 1302 form a curved side edge with high elasticity, the third connecting rod 1303 and the fourth connecting rod 1304 form another curved side edge with high elasticity, at the moment, when the clamping end 16 is impacted suddenly, the reinforcing net 13 deforms and extends relatively elastically, large inertia force generated by the clamping end 16 is buffered, impact force transmitted to the positioning part 12 by the clamping end 16 is reduced, and impact injury of the proximal end of the positioning part 12 to the sinus floor of the aorta is reduced.

Herein, for convenience of description, the links constituting the quadrangular lattice unit 131 are collectively referred to as reinforcing mesh links. The quadrilateral mesh cells 131 may be formed of reinforcing mesh links that are thin in the middle and wide at both ends. Such a structure may optimize the fatigue resistance of the high elasticity anti-regurgitation heart valve stent and improve the resilience of the high elasticity anti-regurgitation heart valve stent.

Next, more details and features of the card end 16 will be described.

The proximal end of the highly resilient regurgitation resistant heart valve stent may comprise a retaining end 16. The retaining end 16 may comprise at least one layer of interconnected diamond-shaped lattice cells 161. The locking end connecting rod 162 constituting the locking end structure unit 161 has a small width at the center and large ends. As shown in fig. 1 and 2, the lever 162 of the locking end structure unit 161 may be symmetrical with a minimum width in the middle and then smoothly enlarged toward both ends without a stepwise abrupt change. The edges of the bar 162 are smooth. In one embodiment, the retaining end structure units 161 are diamond-shaped squares, and the retaining end 16 may include 18 retaining end structure units 161 arranged in a layer and connected to each other. Adjacent card end structural units 161 may be connected to each other by sharing a vertex. The retaining end structural unit connection regions 164 extend a predetermined length circumferentially and longitudinally of the highly elastic anti-regurgitation heart valve stent, respectively.

The proximal flaring of the distal end of the capture end 16 relative to the capture end 16, and the flaring of the distal end of the capture end 16 relative to the proximal end of the capture end 16 is at an angle of 6 ° to 14 °, causes flaring to occur, prevents the reflux stent from being displaced toward the aorta, and anchors in cooperation with the aortic annulus, but does not create an excessive angle because: the clamping end extending into the heart is prevented from touching the bundle of his so as to influence the normal beating of the heart and endanger life.

Next, more details and technical features of the connecting member 14 will be described.

Returning to fig. 1, the connection member 14 may include a connection block 141, a connection web 142, and a connection frame 143. One end of the connecting block 141 forms the proximal end of the heart valve stent, the other end is connected with the connecting frame 143 through the connecting web 142, and the connecting block 141 is used for being connected with a conveyor for conveying the heart valve stent. The distal end of the connecting frame 143 is fixedly connected to the distal ends of the first positioning arm 121 and the second positioning arm 122, and the proximal end of the connecting frame 143 is fixedly connected to the distal ends of the quadrilateral mesh units 131 of the reinforcing mesh 13. This prevents the spacer 12 and the reinforcing mesh 13 from causing secondary damage to the native leaflets by shearing forces.

In one embodiment, the width of the connecting web 142 is less than the width of the connecting piece 141. In another embodiment, the connecting frame 143 includes a hollow elongated suture hole 144. The elongated suture holes 144 may have one end near the distal end of the connecting frame 143 and the other end near the proximal end of the connecting frame 143. The strip-shaped sewing hole 144 can realize that the edge of the near end of the artificial valve leaflet directly passes through the sewing hole to sew without adding a sewing gasket, the edge of the artificial valve leaflet is connected with the covering film in the bracket in a sewing way, the covering film is arranged in the bracket, namely the clamping end 16 and the inner surface of the reinforcing net 13, namely the surface facing the axis of the bracket, the artificial valve leaflet is sewed on the covering film in a mode of sewing the artificial valve leaflet and the bracket, the connecting area of the covering film is wide, the artificial valve leaflet is sewed by utilizing flexible design, the material of the covering film can be made of high polymer materials such as PET (polyethylene terephthalate) or PTFE (polytetrafluoroethylene) or animal pericardium biological tissues, and the covering film covers the inner surface of the bracket in the design to prevent bleeding leakage and achieve the sealing effect; the material of the artificial leaflet may include one or more synthetic materials, engineered biological tissues, biological leaflet tissues, pericardial tissues, cross-linked pericardial tissues, aortic root tissues, chemically or biologically processed/treated tissues, or combinations thereof, and further, the pericardial tissues may be selected from the group consisting of, but not limited to, bovine, equine, porcine, ovine, and human tissues, or combinations thereof. Compared with the traditional mode of using the gasket and the heart valve support to extrude and fix the valve leaflets, the sewing mode firstly reduces the externally-attached parts of the heart valve support, does not have the gasket, is favorable for further compression of the heart valve support, and not only influences the compression of the support if the gasket exists, but also damages the artificial valve leaflets even under the condition that the compressed size of the support is smaller.

Example 2

The present embodiment provides a highly elastic regurgitation-resistant heart valve stent which comprises a support 11 and whose reinforcing mesh 13 comprises a quadrangular lattice cell 161.

Referring to fig. 3 and 4, the high elasticity anti-regurgitation heart valve stent of this embodiment comprises a support member 11, a positioning member 12, a reinforcing mesh 13, a connecting member 14 and a retaining end 16. The distal end of the high-elasticity anti-regurgitation heart valve stent of the embodiment further comprises a support 11 arranged between the adjacent connecting pieces 14, wherein the support 11 is closer to the distal end of the high-elasticity anti-regurgitation heart valve stent than the positioning piece 12 and is used for fixing the native valve leaflets. The support 11 may comprise a first support arm 111, a second support arm 112 and a support distal end 113 connecting the first support arm 111 and the second support arm 112 and protruding towards the proximal end of the highly resilient regurgitation resistant heart valve stent. The first support arm 111 is fixedly connected to a first connector, and the second support arm 112 is fixedly connected to a second connector, the first connector being adjacent to the second connector.

In this embodiment, the positioning member 12 is closer to the distal end of the highly elastic anti-regurgitation heart valve holder than the support member 11. The support distal end 113 and the positioning member distal end 123 are rods that project towards the distal end of the heart valve stent. The support 11 is arranged on one side of the native heart valve leaflets and the positioning member 12 is arranged on the other side of the native heart valve leaflets.

Compared with the traditional heart valve support, the heart valve support also comprises the support 11, so that the native valve leaflets can be clamped between the support 11 and the positioning part 12, the support 11 prevents the native valve leaflets from invading the artificial valve leaflets, the clamping is relatively firmer because the native valve leaflets are clamped by the support 11 and the positioning part 12, and meanwhile, the support 11 is also favorable for the high-elasticity anti-regurgitation heart valve support to smoothly self-dilate, and the radial force during self-dilation is increased.

In one embodiment, referring to fig. 4, the first support arm 111 and the second support arm 112 are linear when the highly elastic anti-regurgitation heart valve stent is in the compressed state. The first positioning arm 111 and the second positioning arm 112 are designed to be linear in order to facilitate compression of the high elasticity anti-regurgitation heart valve stent, and occupy the smallest space when the high elasticity anti-regurgitation heart valve stent is fully compressed, i.e. the adjacent first supporting arm 111 and the second supporting arm 112 are fully close together when compressed. The purpose of the first support arm 111 and the second support arm 112 being linear is to be sufficiently close together without interference when compressed. In addition, the high-elasticity anti-reflux heart valve stent can be formed by cutting one nickel-titanium tube, the linear design is favorable for processing, the processing path is shortened, and the processing cost is reduced.

In this embodiment, the connecting member 14 may include a connecting block 141, a connecting web 142 and a connecting frame 143, one end of the connecting block 141 forms the anti-regurgitation heart valve stent near end, and the other end passes through the connecting web 142 and the connecting frame 143, the distal end of the connecting frame 143 and the distal end fixed connection of the first supporting arm 111 and the second supporting arm 112, and the proximal end of the connecting frame 143 and the distal end fixed connection of the first positioning arm 121, the second positioning arm 122 and the reinforcing mesh 13 quadrilateral mesh unit 131.

In this embodiment, similar to embodiment 1, the positioning member 12 is provided with a composite pull wire ring 124, and the connecting frame 143 includes a hollow elongated suture hole 144. The features of the positioning member 12, the reinforcing mesh 13, the positioning end 16, the pull string composite ring 124, the connecting block 141, the connecting web 142 and the elongated suture hole 144, which are not described in detail in this embodiment, are the same as those of embodiment 1, and thus are not described again.

Example 3

The present embodiment provides a highly elastic regurgitation-resisting heart valve stent whose reinforcing mesh 13 includes a first quadrangular lattice cell 131 and a second quadrangular lattice cell 132.

Referring to fig. 5 and 6, the reinforcing mesh 13 of the high-elasticity anti-regurgitation heart valve stent of the embodiment includes a first quadrilateral mesh cell 131 and a second quadrilateral mesh cell 132, and the first quadrilateral mesh cell 131 is formed by connecting a first link 1301, a second link 1302, a third link 1303 and a fourth link 1304. The proximal end of the first link 1301 is fixedly connected to the distal end of the second link 1302, the proximal end of the fourth link 1304 is fixedly connected to the distal end of the third link 1303, and the second quadrilateral mesh unit 132 is formed by connecting a fifth link 1305, a sixth link 1306, a seventh link 1307, and an eighth link 1308. The proximal end of the fifth link 1305 is fixedly connected to the distal end of the sixth link 1306, and the proximal end of the eighth link 1308 is fixedly connected to the distal end of the seventh link 1307. In this embodiment, the distal ends of the first link 1301 and the fourth link 1304 are fixedly connected to the connecting member 14, the proximal ends of the sixth link 1306 and the seventh link 1307 are fixedly connected to the distal ends of the rhombic grid units 161, and the second link 1302, the third link 1303, the fifth link 1305 and the eighth link 1308 share one vertex.

The reinforcing mesh 13 may include one, two or three layers of quadrangular lattice cells 131, and preferably may include two layers of quadrangular lattice cells 131. The positioning member 12 is required to have a certain length, that is, the distal end 123 of the positioning member is sufficiently inserted into the sinus floor, so that the high-elasticity anti-regurgitation heart valve stent must have a certain axial length. In the case that the reinforcing mesh 13 includes only one quadrilateral mesh unit 131, the torsion resistance of the proximal end of the high-elasticity anti-regurgitation heart valve stent and the torsion resistance of the distal end of the high-elasticity anti-regurgitation heart valve stent are insufficient, so that the high-elasticity anti-regurgitation heart valve stent is easily twisted, and the high-elasticity anti-regurgitation heart valve stent is bent integrally. In addition, in the embodiment in which the reinforcing mesh 13 includes only one quadrilateral mesh cell 131, the reinforcing mesh 13 is too long in the tie bars, and the deformation is large in the heat setting and compression overlength, and it is not easy to control the deformation locus thereof.

And the adoption of the structure of two layers of quadrilateral grid cells 131 can effectively reduce the distance between the proximal end and the distal end of the reinforcing mesh connecting rod of each quadrilateral grid cell 131, and increase the deformation controllability of the quadrilateral grid cells 131.

The features of the positioning member 12, the connecting member 14, the clamping end 16, and the pull wire composite ring 124, which are not described in detail in this embodiment, are the same as those of embodiment 1, and thus are not described again.

Example 4

The embodiment provides a high elasticity anti-regurgitation heart valve stent, the reinforcing mesh 13 of which comprises a first quadrilateral mesh cell 131 and a second quadrilateral mesh cell 132. In addition, the highly elastic regurgitation-resistant heart valve stent of the present embodiment further comprises a support 11.

Referring to fig. 7 and 8, the high-elasticity anti-regurgitation heart valve stent of the present embodiment is compared with the high-elasticity anti-regurgitation heart valve stent of the embodiment 2 in that the reinforcing mesh 13 of the high-elasticity anti-regurgitation heart valve stent of the present embodiment comprises a first quadrangular grid cell 131 and a second quadrangular grid cell 132, and the first quadrangular grid cell 131 is formed by connecting a first link 1301, a second link 1302, a third link 1303 and a fourth link 1304. The proximal end of the first link 1301 is fixedly connected to the distal end of the second link 1302, the proximal end of the fourth link 1304 is fixedly connected to the distal end of the third link 1303, and the second quadrilateral mesh unit 132 is formed by connecting a fifth link 1305, a sixth link 1306, a seventh link 1307, and an eighth link 1308. The proximal end of the fifth link 1305 is fixedly connected to the distal end of the sixth link 1306, and the proximal end of the eighth link 1308 is fixedly connected to the distal end of the seventh link 1307. In this embodiment, the distal ends of the first link 1301 and the fourth link 1304 are fixedly connected to the connecting member 14, the proximal ends of the sixth link 1306 and the seventh link 1307 are fixedly connected to the distal ends of the rhombic lattice unit 161, and the second link 1302, the third link 1303, the fifth link 1305 and the eighth link 1308 share one vertex.

The features of the supporting member 11, the positioning member 12, the connecting member 14, the clamping end 16, and the pull-string composite ring 124, which are not described in detail in this embodiment, are the same as those of embodiment 2, and are not repeated herein.

Example 5

The embodiment provides a high elasticity anti-regurgitation heart valve stent, the reinforcing mesh 13 of which comprises a first quadrilateral mesh cell 131, a second quadrilateral mesh cell 132 and two third quadrilateral mesh cells 133.

Referring to fig. 9 to 13, compared to embodiment 3, the reinforcing mesh 13 of this embodiment further includes two third quadrangular grid cells 133 symmetrically disposed on both sides of the second quadrangular grid cell 132, and the proximal ends of the third quadrangular grid cells 133 are fixedly connected to the distal ends of the rhombic grid cells 161 of the clamping end 16, but the distal ends of the third quadrangular grid cells 133 are free ends.

Specifically, the third quadrangular lattice unit 133 can be formed by connecting ninth link 1309, tenth link 1310, eleventh link 1311, and twelfth link 1312. A proximal end of the ninth link 1309 is fixedly connected to a distal end of the tenth link 1310, and a proximal end of the twelfth link 1312 is fixedly connected to a distal end of the eleventh link 1311. As for the third quadrangular lattice unit 133 disposed to the left of the second quadrangular lattice unit 132, the eleventh link 1311 and the twelfth link 1312 of the third quadrangular lattice unit 133 share one vertex with the fifth link 1305 and the sixth link 1306 of the second quadrangular lattice unit 132. As for the third quadrangular lattice unit 133 disposed at the right side of the second quadrangular lattice unit 132, the ninth link 1309 and the tenth link 1310 of the third quadrangular lattice unit 133 share one vertex with the seventh link 1307 and the eighth link 1308 of the second quadrangular lattice unit 132. Meanwhile, the distal end of the ninth link 1309 is fixedly connected to the distal end of the twelfth link 1312 without being connected to other components of the high elastic regurgitation resisting heart valve stent, so as to form the free end of the third quadrilateral mesh unit 133. The proximal end of the tenth link 1310 is fixedly connected to the proximal end of the eleventh link 1311 and shares a vertex with the distal end of the diamond-shaped grid cells 161 of the clamping end 16.

In the embodiment, the number of the two layers of quadrilateral grid cells 131 is increased (preferably 2 for each layer) along the distal end of the high-elasticity anti-regurgitation heart valve stent towards the proximal end of the high-elasticity anti-regurgitation heart valve stent, and the proximal ends of the upper layer of quadrilateral grid cells 131 are connected with the distal ends of the lower layer of quadrilateral grid cells 131 instead of being intersected to form a network structure, and the outer contour of the reinforcing net 13 approximately forms a triangular reinforcing net 13 as a whole, so that the stability between the proximal end of the high-elasticity anti-regurgitation heart valve stent and the distal end of the high-elasticity anti-regurgitation heart valve stent can be effectively increased. In the embodiment, the reinforcing mesh 13 has two layers of quadrilateral mesh units, and the number of quadrilateral mesh units in each layer from the far end to the near end of the reinforcing mesh 13 is 1 and 3 respectively, and other embodiments may also be 1 and 5, etc.

Furthermore, when the reinforcing mesh 13 is provided with a plurality of layers of quadrilateral mesh units 131, at least one layer of quadrilateral mesh units 131 is 1, so that the elasticity of at least one layer of quadrilateral mesh units 131 of the reinforcing mesh 13 in the axial direction is ensured, and because a plurality of quadrilateral mesh units 131 are designed on one layer of the reinforcing mesh, the axial elasticity of the reinforcing mesh is inevitably reduced, the damping effect of the reinforcing mesh 13 on the positioning part 12 is affected, and therefore, the reinforcing mesh 13 is required to be ensured to have at least one layer of quadrilateral mesh units 131 of 1;

in some embodiments, the reinforcing mesh 13 has a plurality of layers (greater than 2 layers) of quadrilateral mesh units, and the number of quadrilateral mesh units 131 in each layer from the far end to the near end of the reinforcing mesh 13 may not be all increased, but may be partially equal, for example, 1, 3, or 1, 5 quadrilateral mesh units 131 in each layer from the far end to the near end of the reinforcing mesh 13.

Example 6

The present embodiment provides a highly elastic regurgitation-resisting heart valve stent whose reinforcing mesh 13 includes a first quadrangular lattice cell 131, a second quadrangular lattice cell 132 and two third quadrangular lattice cells 133. In addition, the highly elastic regurgitation-resistant heart valve stent of the present embodiment further comprises a support 11.

Referring to fig. 14 and 15, compared to embodiment 4, the reinforcing mesh 13 of this embodiment further includes two third quadrilateral mesh units 133 symmetrically disposed on both sides of the second quadrilateral mesh unit 132, and the proximal ends of the third quadrilateral mesh units 133 are fixedly connected to the distal ends of the diamond-shaped mesh units 161 of the clamping end 16, but the distal ends of the third quadrilateral mesh units 133 are free ends.

Specifically, the third quadrangular lattice unit 133 can be connected by a ninth link 1309, a tenth link 1310, an eleventh link 1311, and a twelfth link 1312. A proximal end of the ninth link 1309 is fixedly connected to a distal end of the tenth link 1310, and a proximal end of the twelfth link 1312 is fixedly connected to a distal end of the eleventh link 1311. As for the third quadrangular lattice unit 133 disposed to the left of the second quadrangular lattice unit 132, the eleventh link 1311 and the twelfth link 1312 of the third quadrangular lattice unit 133 share one vertex with the fifth link 1305 and the sixth link 1306 of the second quadrangular lattice unit 132. As for the third quadrangular lattice unit 133 disposed at the right side of the second quadrangular lattice unit 132, the ninth link 1309 and the tenth link 1310 of the third quadrangular lattice unit 133 share one vertex with the seventh link 1307 and the eighth link 1308 of the second quadrangular lattice unit 132. At the same time, the distal end of the ninth link 1309 is fixedly connected to the distal end of the twelfth link 1312, and is not connected to other components of the high elasticity anti-regurgitation heart valve stent, forming the free end of the third quadrilateral mesh unit 133. The proximal end of the tenth link 1310 is fixedly connected to the proximal end of the eleventh link 1311 and shares a vertex with the distal end of the diamond-shaped grid cells 161 of the clamping end 16.

In the present embodiment, it is preferred that,

Furthermore, when the reinforcing mesh 13 is provided with a plurality of layers of quadrilateral mesh units 131, at least one layer of quadrilateral mesh unit 131 is 1, so that the at least one layer of quadrilateral mesh unit 131 of the reinforcing mesh 13 is ensured to have elasticity in the axial direction, and because a plurality of quadrilateral mesh units 131 are designed on one layer of the reinforcing mesh, the axial elasticity of the reinforcing mesh is inevitably reduced, the damping effect of the reinforcing mesh 13 on the positioning member 12 is affected, and therefore, the reinforcing mesh 13 is required to be ensured to have at least one layer of quadrilateral mesh unit 131 of 1.

Example 7

This example provides a highly elastic anti-regurgitation heart valve stent similar in structure to the highly elastic anti-regurgitation heart valve stent described in example 5. The only difference is that the first positioning arm 121 and the second positioning arm 122 of the positioning member 12 are curved. Specifically, the first positioning arm 121 may include a first positioning arm projecting portion 125 projecting toward the adjacent connector, and the second positioning arm 122 may include a second positioning arm projecting portion 126 projecting toward the adjacent connector. The use of curved cut spacers 12 allows for longer spacers 12 to be cut for the same length of nitinol tube as compared to conventional cut linear spacers 12. This effectively increases the axial length of the spacer 12 in the extended condition. In other words, for a length of the high elasticity anti-regurgitation heart valve stent, the positioning member 12 using the curved cut is relatively straightened when the high elasticity anti-regurgitation heart valve stent is in its expanded state, which enables insertion deeper into the sinus floor.

The embodiments described above are intended to facilitate the understanding and appreciation of the application by those skilled in the art. It will be readily apparent to those skilled in the art that various modifications to these embodiments may be made, and the generic principles described herein may be applied to other embodiments without the use of the inventive faculty. Therefore, the present application is not limited to the embodiments herein, and those skilled in the art who have the benefit of this disclosure will appreciate that many modifications and variations are possible within the scope of the present application without departing from the scope and spirit of the present application.

Claims

1. The utility model provides an anti regurgitation heart valve support of high elasticity, anti regurgitation heart valve support of high elasticity includes the anti regurgitation heart valve support of high elasticity proximal end of heart and the anti regurgitation heart valve support distal end of high elasticity, its characterized in that, the anti regurgitation heart valve support of high elasticity distal end of heart is including setting up the setting element between adjacent connecting piece, the setting element is used for fixing a position the anti regurgitation heart valve support of high elasticity, the setting element includes first locating arm, second locating arm and connects first locating arm and second locating arm and towards the bellied setting element distal end of the anti regurgitation heart valve support of high elasticity proximal end;

2. The highly elastic regurgitation-resistant heart valve stent of claim 1, wherein the reinforcing mesh comprises a first quadrilateral mesh unit formed by connecting a first link, a second link, a third link and a fourth link, a proximal end of the first link being fixedly connected to a distal end of the second link and a proximal end of the fourth link being fixedly connected to a distal end of the third link;

3. The highly elastic regurgitation-resistant heart valve stent of claim 2, wherein the reinforcing mesh comprises a first quadrangular lattice unit formed by connecting a first link, a second link, a third link and a fourth link, a proximal end of the first link being fixedly connected to a distal end of the second link, a proximal end of the fourth link being fixedly connected to a distal end of the third link, and a second quadrangular lattice unit formed by connecting a fifth link, a sixth link, a seventh link and an eighth link, a proximal end of the fifth link being fixedly connected to a distal end of the sixth link, and a proximal end of the eighth link being fixedly connected to a distal end of the seventh link;

4. The highly elastic regurgitation resisting heart valve stent of claim 3, wherein the reinforcing mesh further comprises two third quadrilateral mesh units, the two third quadrilateral mesh units are symmetrically arranged on two sides of the second quadrilateral mesh unit, one side of the third quadrilateral mesh unit close to the second quadrilateral mesh unit shares a vertex with the second quadrilateral mesh unit, the proximal ends of the third quadrilateral mesh units are fixedly connected to the distal ends of the rhombic mesh units, and the distal ends of the third quadrilateral mesh units are free ends.

5. The high elasticity heart valve stent against regurgitation of claim 4, wherein when the quadrilateral grid cells are two layers, the number of the quadrilateral grid cells increases along the distal end of the high elasticity heart valve stent against regurgitation towards the proximal end of the high elasticity heart valve stent against regurgitation.

6. The highly elastic anti-regurgitation heart valve stent of claim 5, wherein the reinforcing mesh is provided with a plurality of layers of quadrangular lattice cells, and at least one layer of quadrangular lattice cells is 1.

7. The highly elastic regurgitation resisting heart valve stent of claim 6, wherein the reinforcing mesh has at least three layers of quadrilateral mesh cells, and the number of quadrilateral mesh cells in each layer from the distal end to the proximal end of the reinforcing mesh is not all incremental but partially remains equal.

8. The highly elastic regurgitation resisting heart valve stent of claim 1, wherein the quadrilateral mesh cells are comprised of reinforcing mesh links which are thin in the middle and wide at both ends;

the rhombic grid units are formed by clamping end connecting rods, and the middle of each clamping end connecting rod is thin, and the two ends of each clamping end connecting rod are wide.

9. The highly resilient anti-regurgitation heart valve stent of claim 1, wherein the first positioning arm and the second positioning arm are linear or curved.

10. The highly elastic regurgitation resisting heart valve stent of claim 1, wherein the positioning elements have a splay angle of 2 ° to 14 ° when the highly elastic regurgitation resisting heart valve stent is expanded.

11. The highly resilient anti-regurgitation heart valve stent of claim 1, wherein the positioning member distal end is parabolic in shape.

12. The highly elastic regurgitation resisting heart valve stent of claim 1, wherein the perpendicular distance from the distal end of the positioning member to the distal end of the retaining end is 2mm to 8mm.

13. The highly resilient anti-regurgitation heart valve stent of claim 1, wherein the distal ends of the capture ends flare proximally relative to the capture ends and the distal ends of the capture ends flare distally at an angle of 6 ° to 14 ° relative to the proximal ends of the capture ends.

14. The highly elastic anti-regurgitation heart valve stent of claim 9, wherein the connecting piece comprises a connecting block, a connecting web and a connecting frame, one end of the connecting block forms the anti-regurgitation heart valve stent proximal end, the other end is connected with the connecting frame through the connecting web, the distal end of the connecting frame is fixedly connected with the distal ends of the first positioning arm and the second positioning arm, and the proximal end of the connecting frame is fixedly connected with the distal ends of the quadrilateral mesh units.

15. The highly elastic regurgitation resistant heart valve stent of claim 14, wherein the attachment frame includes elongated suture holes adapted to be penetrated by the prosthetic leaflet and having one end near the distal end of the attachment frame and the other end near the proximal end of the attachment frame.

16. The highly resilient regurgitation resisting heart valve stent of any one of claims 1-15 wherein the highly resilient regurgitation resisting heart valve stent distal end further comprises a support disposed between adjacent connectors, the support being closer to the distal end of the highly resilient regurgitation resisting heart valve stent than the positioning member and being for fixation of native leaflets;

17. The high-elasticity anti-regurgitation heart valve stent of claim 16, wherein the connecting piece comprises a connecting block, a connecting web and a connecting frame, one end of the connecting block forms the anti-regurgitation heart valve stent proximal end, and the other end passes through the connecting web and the connecting frame is connected, the distal end of the connecting frame is fixedly connected with the distal ends of the first and second support arms, and the proximal end of the connecting frame is fixedly connected with the first and second positioning arms and the distal ends of the quadrilateral mesh units.