CN115381598A

CN115381598A - Self-expanding heart valve stent comprising a cover

Info

Publication number: CN115381598A
Application number: CN202210658355.4A
Authority: CN
Inventors: 吴明明; 陈海琴; 王春光; 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Koka Nantong Lifesciences Co Ltd
Priority date: 2022-03-28
Filing date: 2022-06-10
Publication date: 2022-11-25
Also published as: CN116807685A; CN117752467A; CN115381597A; CN219000720U; CN218792636U; CN115624416B; CN219332099U; CN115105259A; CN115624416A; CN218356472U; CN116869705A; CN218356470U; CN219000725U; CN116849870A; CN218792637U; CN116849871A; CN115670750B; CN218356471U; CN116807686A; CN117752468A

Abstract

The invention discloses a self-expanding heart valve stent containing a covering film, which comprises a flexible grid-shaped woven covering film, wherein the flexible grid-shaped woven covering film is fixed on the inner side of the far end of the self-expanding heart valve stent containing the covering film and is used for fixing artificial valve leaflets; the proximal end of the self-expanding heart valve stent comprises connecting pieces and fasteners arranged between the adjacent connecting pieces, wherein the fasteners are used for fixing the artificial heart valve leaflet together with the grid-shaped woven covering film. The covering film is arranged between the artificial valve leaflet and the self-expanding heart valve support, so that the self-expanding heart valve support is convenient to compress, the artificial valve leaflet can be suitable for self-expanding heart valve supports with different sizes, and the universality of the artificial valve leaflet is improved. In addition, the two sides of the main body of the artificial valve leaflet, which are close to the far end, are provided with the concave regions, namely the artificial valve leaflet uses less material and has larger space for accommodating the material extruded in the extrusion process, so that the transitional extrusion condition on the suture position of the valve leaflet can not be generated in the process of straightening the fastener.

Description

Self-expanding heart valve stent comprising a cover

Technical Field

The invention relates to the technical field of medical equipment, in particular to a self-expanding heart valve stent containing a tectorial membrane.

Background

Since the way of performing surgery via a catheter has many advantages such as less trauma and fast recovery, more and more surgeries are beginning to be performed via a catheter. Aortic valve replacement was also changed from the earlier surgical approach to transcatheter aortic valve replacement. Heart valve stents are important medical devices for performing aortic replacement procedures.

The conventional way for sewing the artificial valve leaflet to the self-expanding cardiac valve stent containing the covering film is to sew the artificial valve leaflet to the self-expanding cardiac valve stent containing the covering film, such as a fastening arc, but the surface of the fastening arc is smooth, so that the artificial valve leaflet is not firmly fixed, and needs to be set to be in a curve shape through the fastening arc or a fixing hole is increased.

Since the self-expanding heart valve stent is greatly limited in both material thickness and width due to the small diameter that needs to be compressed, it is desirable that the self-expanding heart valve stent including a cover film is not disturbed by excessive external forces, such as forces from the cover film, when compressed.

To this end, there is a continuing need in the art to develop a self-expanding heart valve stent containing a covering membrane that facilitates compression.

Disclosure of Invention

The invention aims to provide a self-expanding heart valve stent containing a covering film, which is convenient to compress and has strong universality of an artificial valve leaflet. In particular, the covered self-expanding heart valve stent described herein includes a flexible, lattice-like woven covering secured to the inside of the distal end of the covered self-expanding heart valve stent for securing a prosthetic leaflet. Therefore, the buffering can be provided between the artificial valve leaflet and the support, the self-expanding heart valve support can adapt to self-expanding heart valve supports with different sizes, the universality of the artificial valve leaflet is increased, meanwhile, the sealing performance between the support and the aortic wall is also increased, and the side leakage of blood is prevented.

In order to achieve the above object, the present invention provides the following technical solutions.

In a first aspect, the present application provides a self-expanding stent-heart valve comprising a cover, including a distal end of the self-expanding stent-heart valve proximal to the apex of the heart when the self-expanding stent-heart valve is in an expanded state and a proximal end of the self-expanding stent-heart valve distal to the apex of the heart when the self-expanding stent-heart valve is in an expanded state, characterized in that the self-expanding stent-heart valve comprising a flexible mesh-like woven cover, the flexible mesh-like woven cover being fixed inside the distal end of the self-expanding stent-heart valve comprising a cover for fixing a prosthetic leaflet;

the proximal end of the self-expanding heart valve stent comprises connecting pieces and a fastener arranged between the adjacent connecting pieces, the fastener is used for fixing the artificial heart valve leaflet together with the latticed woven covering film, the fastener comprises a first fastening arc, a second fastening arc and a fastener distal end for connecting the first fastening arc and the second fastening arc, the first fastening arc is fixedly connected to the first connecting piece, the second fastening arc is fixedly connected to the second connecting piece, and the first connecting piece is adjacent to the second connecting piece.

In one embodiment of the first aspect, the first and second fastening arcs of the fastener comprise, when the self-expanding heart valve stent is in the expanded state:

a fastening arc recessed portion that is an arc-shaped rod-like structure that is convex toward a direction away from the self-expanding heart valve stent and that is convex toward a proximal end of the self-expanding heart valve stent at the same time;

a fastening arc projection portion that is an arc-shaped rod-like structure that projects toward a self-expanding heart valve stent and that simultaneously projects toward a distal end of the self-expanding heart valve stent;

the proximal end of the fastening arc concave part is connected to the connecting piece, the distal end of the fastening arc concave part is fixedly connected with the fastening arc convex part, and the distal end of the fastening arc convex part is connected with the adjacent fastening arc convex part through the distal end of the fastening piece.

In one embodiment of the first aspect, the lattice-shaped woven cover is woven from longitudinal threads and lateral threads, and an angle between the longitudinal threads and the lateral threads is set to 60 ° to 90 °.

In one embodiment of the first aspect, the lattice-woven cover is secured to the self-expanding heart valve stent including a cover by sewing with components of the self-expanding heart valve stent including a cover;

the distal end of the self-expanding heart valve stent containing the covering film comprises a clamping end, the clamping end comprises a diamond structure which is connected with each other, and the longitudinal lines of the latticed woven covering film and one of the connecting rods of the diamond structure are fixed on the self-expanding heart valve stent in parallel.

In one embodiment of the first aspect, the distal end of the retaining end is provided with a retaining end outer coating that acts as a leak-proof skirt, covering the distal end up to the proximal end of the fastener.

In one embodiment of the first aspect, the clamping end outer cover is the inner cover everted to the outside, or a single cover.

In one embodiment of the first aspect, the self-expanding heart valve stent including a cover film further comprises a prosthetic leaflet including a prosthetic leaflet body and an ear, an outer contour of the prosthetic leaflet body including an inner concave region recessed toward the prosthetic leaflet;

the connecting piece comprises a connecting block, a connecting web and a connecting frame, one end of the connecting block forms the near end of the self-expanding cardiac valve stent containing the covering film, the other end of the connecting block is connected with the connecting frame through the connecting web, and the connecting frame sequentially comprises a positioning piece connecting part and a fastener connecting part along the direction from the near end of the self-expanding cardiac valve stent containing the covering film to the far end of the self-expanding cardiac valve stent containing the covering film;

the proximal end of the artificial valve leaflet is fixed to the connecting piece of the self-expanding heart valve support containing the covering film, and the distal end of the artificial valve leaflet is fixedly connected to the grid-shaped woven covering film across the fastening arc of the fastener.

In one embodiment of the first aspect, the proximal end of the prosthetic leaflet is secured to the connector of the self-expanding heart valve stent containing the covering membrane by or around undulating sutures.

In one embodiment of the first aspect, the proximal end of the prosthetic leaflet is secured to the connector of the self-expanding stent containing the covering membrane by means of a surrounding suture, each adjacent surrounding suture being independent and the surrounding suture being looped around the connecting frame such that the ears of the prosthetic leaflet closely fit the side posts of the connecting frame.

In one embodiment of the first aspect, the proximal end of the prosthetic leaflet is secured to the attachment member of the self-expanding stent comprising a covering membrane by way of a circumscribing suture formed from one clockwise spirally wound circumscribing suture and another counterclockwise spirally wound circumscribing suture, from top to bottom, each spirally wound circumscribing suture employing an integral spiral circumscribing suture as opposed to the aforementioned independent circumscribing sutures.

In one embodiment of the first aspect, the proximal end of the artificial leaflet is fixed to the connecting piece of the self-expanding cardiac valve stent containing the covering film by means of wavy sutures, the ear of the artificial leaflet passes through the connecting frame and bypasses the side column of the connecting frame to make the tail end of the ear return to the inside of the self-expanding cardiac valve stent containing the covering film, and is attached to the artificial leaflet at the joint of the artificial leaflet main body and the ear, and the wavy sutures penetrate through the artificial leaflet located in the same connecting frame to tightly combine the tail end of the ear of the artificial leaflet and tightly combine the main body of the adjacent artificial leaflet with the ear joint, so that the fixation of the artificial leaflet and the tight combination of the adjacent artificial leaflet close to the stent side are realized.

In one embodiment of the first aspect, the artificial leaflet further comprises an anti-wear strip disposed on an outer contour of the artificial leaflet body.

In one embodiment of the first aspect, the artificial leaflet is provided with ears that are inclined downward relative to a superior flat line of the artificial leaflet main body.

In one embodiment of the first aspect, the mesh-like woven covering film is woven from a PET material and has a thickness smaller than that of the artificial leaflet.

Compared with the prior art, the beneficial effect of this application lies in:

1) The covering film is arranged between the artificial valve leaflet and the self-expanding heart valve support, compared with the integrated artificial valve leaflet, the existing artificial valve leaflet and the covering film with thinner thickness are combined to form the whole artificial valve leaflet, the self-expanding heart valve support is convenient to compress, meanwhile, the artificial valve leaflet is sewn on the covering film, and compared with a mode of being fixed on the support, the self-expanding heart valve support can be more flexibly adapted, because the shapes of fasteners of the supports with different sizes after being expanded are different, and the artificial valve leaflet is sewn on the covering film, the artificial valve leaflet with the same geometric shape (the valve leaflet is enlarged and reduced in an equal proportion without changing the geometric shape characteristics) can be flexibly suitable for the self-expanding heart valve supports with different sizes, and the universality of the artificial valve leaflet is improved;

2) The two sides of the main body of the artificial valve leaflet, which are close to the far end, are provided with the concave areas, namely the material of the artificial valve leaflet is less, and the concave areas and the convex part sections of the fastening arc of the fastening piece keep the same arc direction, when the bracket is compressed, namely the fastening piece is straightened, the concave areas of the artificial valve leaflet can not generate larger reaction force to the convex part of the fastening arc to influence the compression of the bracket.

Drawings

The technical features and advantages of the present invention are more fully understood by reference to the following detailed description in conjunction with the accompanying drawings.

FIG. 1 shows a perspective view of a self-expanding heart valve stent including a covering membrane in an expanded state after installation of a lattice-woven covering membrane according to another embodiment.

Fig. 2 shows a perspective view of a self-expanding heart valve stent containing a covering membrane in an expanded state after installation of a prosthetic leaflet according to yet another embodiment.

FIG. 3 shows a schematic view of a lattice-shaped braided covering membrane according to one embodiment.

Fig. 4 shows a schematic view of an artificial leaflet according to an embodiment.

Fig. 5 shows a partial enlarged view of the recessed area in fig. 4.

Fig. 6 shows a schematic view of an artificial leaflet according to another embodiment.

Fig. 7 shows a schematic view of an artificial leaflet according to another embodiment.

Fig. 8 shows a perspective view of a self-expanding heart valve stent containing a covering membrane in an expanded state after installation of a prosthetic leaflet according to yet another embodiment.

Fig. 9 shows a partial enlarged view of the area a in fig. 8.

Fig. 10 shows a perspective view of a self-expanding heart valve stent containing a covering membrane in an expanded state after installation of a prosthetic leaflet according to yet another embodiment.

Fig. 11 shows a partial enlarged view of the region B in fig. 10.

FIG. 12 shows a schematic view of the self-expanding heart valve stent of FIG. 1 without the lattice-like braided covering.

FIG. 13 shows a deployed view of the self-inflating heart valve stent of FIG. 12.

Fig. 14 shows a partial enlarged view of the area a in fig. 13.

Fig. 15 is a partially enlarged view of the region B in fig. 13.

FIG. 16 shows a schematic view of a self-expanding heart valve stent without a lattice-like braided covering, according to another embodiment.

Fig. 17A shows a partial enlarged view of the region F in fig. 16.

FIG. 17B shows a schematic view of a fastener.

FIG. 18 shows a schematic view of a self-expanding heart valve stent without a lattice-like braided covering membrane, according to another embodiment.

FIG. 19 shows a deployed view of the self-inflating heart valve stent of FIG. 18.

Fig. 20 shows a partial enlarged view of the area B in fig. 19.

Fig. 21 shows a partial enlarged view of the area C in fig. 19.

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," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or to implicitly indicate a number of the indicated technical features. 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 meaning 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 the side of the delivery device or 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 and proximal ends refer to the same location, and the proximal and distal ends refer to the same location, but this does not preclude transapical implantation, but rather the cardiac valve stent is described herein as being delivered by a catheter through the aorta.

Example 1

The embodiment relates to a self-expanding heart valve support containing a covering film, wherein a flexible grid-shaped woven covering film is arranged between a prosthetic valve leaflet and a connecting piece of the self-expanding heart valve support, the grid-shaped woven covering film is fixedly connected to the inner side of the far end of the heart valve support, the near end of the prosthetic valve leaflet can be sewn to the connecting piece of the near end of the self-expanding heart valve support, and the far end of the prosthetic valve leaflet can be fixedly connected to the grid-shaped woven covering film. The tectorial membrane is relatively soft to allow certain displacement, so can not produce powerful tearing power to artifical leaflet, guaranteed artifical leaflet's safety, increased artifical leaflet's commonality.

The tectorial membrane that traditional heart valve support adopted is mostly the material that PET was woven, and the line of weaving is mostly violently flat vertical, and PET weaves the horizontal line and the vertical line mutually perpendicular 90 of cloth promptly, and when sewing up, PET weaves the vertical line of cloth and should contain the tectorial membrane from the heart valve support of expanding parallel to each other of axis, and the horizontal line is parallel with the circumferential direction that should contain the tectorial membrane from the heart valve support of expanding, so in this contain the self-expanding heart valve support compression process of tectorial membrane, because tectorial membrane and support are fixed mutually. Therefore, the length of the longitudinal line of the PET woven cloth is determined, the self-expanding heart valve stent containing the covering film can increase in the compression process, particularly the length of the upper connecting point and the lower connecting point of the connecting rods of the diamond structures of the clamping ends can be increased, and the longitudinal line (hereinafter referred to as the longitudinal line) fixing the PET covering film with the self-expanding heart valve stent can not increase, so that the longitudinal line can prevent the diamond structures of the clamping ends from being compressed and lengthened, the diamond structures can be continuously compressed under the action of external force, the longitudinal line can always prevent the diamond structures from being compressed, and the diamond structures of the clamping ends can be easily deformed under the action of two forces of compression and compression resistance to damage the diamond structures. However, it should be noted that the compression-resisting force generated by the conventional transverse, flat and vertical PET covering film not only acts on the diamond-shaped structures at the clamping ends, but also acts on the diamond-shaped structures and the fasteners of the reinforcing mesh to resist the compression of the two structures, so that the compression of the whole stent is affected, and even the acting force generated by the conventional transverse, flat and vertical PET covering film to prevent the self-expanding heart valve stent containing the covering film can cause the whole stent to be damaged in the compression process.

Referring to fig. 1 and 2, in one embodiment, the self-expanding heart valve stent including the cover film is covered with a mesh woven from a PET material, and the cover film 3 can be sewn to the components of the self-expanding heart valve stent because the self-expanding heart valve stent is intricate, so that the cover film can be firmly fixed inside the self-expanding heart valve stent. Because the size of the self-expanding heart valve support can be changed, if the artificial valve leaflet is directly sewn with the self-expanding heart valve support, and because the shapes of the fasteners of the supports with different sizes after expansion are different, the size and the shape of the artificial valve leaflet need to be changed along with the change of the self-expanding heart valve support, the universality of the artificial valve leaflet is reduced, and the cost is increased. If the size of the valve leaflet is changed to adapt to the supports with different sizes, the performance parameters of the artificial valve leaflet are inevitably out of the standard requirements, so if the artificial valve leaflet is fixed on the support, the size and the shape of the artificial valve leaflet are required to be changed by changing the size of the support, the artificial valve leaflet is required to be redesigned to reach the standard, and the design strength of a designer is also increased if the artificial valve leaflet is not universal.

The method adopts the combination of the artificial valve leaflet and the covering film, and compared with the traditional method of using the integral artificial valve leaflet to cover the whole self-expanding heart valve support, the compressibility of the self-expanding heart valve support is increased.

The prosthetic leaflet can comprise 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. In some embodiments, the pericardial tissue is selected from, but not limited to, the group consisting of bovine, equine, porcine, ovine, and human tissue, or combinations thereof.

In the embodiment, the far end of the artificial valve leaflet 2 is not fixedly connected with the fastener 13 any more but strides over the fastener 13, and is fixedly connected with the fastener 13 and the covering film 3 of the self-expanding heart valve support with the covering film at the clamping end, because the covering film 3 can be penetrated by the suture line at will, the artificial valve leaflet 2 can be firmly connected with the covering film 3, the suture density can be increased, the sealing performance between the artificial valve leaflet 2 and the covering film 3 is better, the blood is prevented from leaking through the combination position of the artificial valve leaflet 2 and the covering film 3, and the covering film 3 and the artificial valve leaflet 2 are sutured, so that an operator does not need to make the suture line frequently bypass the fastener 13 or a fixing hole, the labor intensity of the operator is reduced, and the efficiency is improved.

In a specific embodiment, if the artificial valve leaflet is directly sutured with the self-expanding heart valve stent, the artificial valve leaflet inevitably moves along with the stent along with the change of the stent, and the motion of the stent is rigid relative to the covering film, namely the motion state is fixed, so that the artificial valve leaflet is sutured with the stent.

In one embodiment, the PET woven fabric is designed to improve the fixation of the artificial leaflet to the connecting frame in order that the covering film 3 can adapt to the self-expanding heart valve stent including the covering film.

PET woven fabrics are usually woven from lengthwise (warp) and crosswise (filling) threads. Referring to fig. 4, the angle between the longitudinal and transverse lines of the pet woven cloth is set to 60 to 90 °. The reason for setting this angle is that: the included angle (acute angle or obtuse angle complement angle) formed by any two directly connected connecting rods in the diamond structure of the clamping end 16 of the self-expanding heart valve stent and the reinforcing net 15 thereof ranges from 60 degrees to 90 degrees, so that the included angle formed by the longitudinal line and the transverse line of the PET woven cloth is consistent with the included angle (acute angle or obtuse angle complement angle) formed by the connected connecting rods in the diamond structure. It is stated that when the angle formed by the connecting rods in the diamond structure is 90 degrees, the angle formed by the longitudinal line and the transverse line of the PET woven cloth is also 90 degrees, while the angle formed by the connecting rods in the diamond structure is generally not less than 60 degrees, if the angle is too small, the supporting force of the diamond structure can be influenced.

When in sewing, the longitudinal line of the PET woven cloth is required to be ensured to be fixed on the bracket in parallel with one connecting rod of the diamond structure, and because the included angle formed by the transverse line and the longitudinal line is the same as the acute angle in the diamond structure, the adjacent connecting rod directly connected with the connecting rod fixed with the PET woven cloth is parallel to the transverse line of the PET woven cloth. At this time, the horizontal line is fixed to the link. By analogy, the clamping end 16 and each connecting rod of the diamond structure of the reinforcing net 15 are respectively parallel to and fixedly connected with the longitudinal line or the transverse line of the PET woven cloth. At this time, when the self-expanding heart valve stent containing the covering film is compressed, the PET woven cloth fixedly connected with the connecting rod with the diamond structure moves along with the connecting rod, and the upper connecting point and the lower connecting point of the connecting rod with the diamond structure are also formed by a plurality of longitudinal lines and transverse lines instead of being formed by one longitudinal line (transverse line). When the transverse lines and the longitudinal lines of the PET woven cloth move along with the connecting rods of the diamond structures, the transverse lines or the longitudinal lines which are originally inclined relative to the axis of the self-expanding cardiac valve stent containing the covering film are gradually changed into a state of being parallel to the axis of the stent, and the axial distance between the transverse lines and the longitudinal lines (which refers to the distance along the axis direction of the self-expanding cardiac valve stent containing the covering film) is gradually increased. At the moment, the axial distance of the PET woven cloth is lengthened along with the compression of the self-expanding heart valve stent containing the covering film, so that the backflow stent is not blocked from compression deformation. In this context, the connecting rods of the diamond-shaped structure may comprise the rods 152 of the reinforcing mesh structure unit 151 or the rods 162 of the locking end structure unit 161, which are described below.

In one embodiment, as shown in fig. 8 and 9, the ear 403 of the artificial leaflet 3 passes through the connecting frame 143 and passes around the side pillar of the connecting frame 143 so that the tail end of the ear is returned to the inside of the self-expanding heart valve stent containing the covering film, and is attached to the artificial leaflet where the main body of the artificial leaflet is attached to the ear, and the wave-shaped sewing thread 5 penetrates through the artificial leaflet 3 located in the same connecting frame, so that the tail end of the ear 403 of the artificial leaflet is closely attached to the artificial leaflet 3, and the main body 404 of the adjacent artificial leaflet is closely attached to the ear 403 (hereinafter referred to as the ear attachment), thereby realizing the fixation of the artificial leaflet 2 and the close attachment of the adjacent artificial leaflet to the stent side. The wavy fold line means that the suture line is sewn according to the path of the wavy line, the contact area of the joint of the tail end of the ear of the artificial valve leaflet and the ear of the artificial valve leaflet is increased, the stability is improved, the contact area of the joint of the ear of the adjacent artificial valve leaflet is also increased, and the blood backflow of the artificial valve leaflet close to the side of the bracket is prevented.

In one embodiment, as shown in fig. 10 and 11, since the artificial leaflet 2 has a certain elasticity and the artificial leaflet is fixed only by the wavy sutures, the wrapping force of the artificial leaflet to the side post needs to be increased so as to increase the surrounding sutures 6 because the artificial leaflet slides relative to the side post connected to the frame due to the elasticity of the artificial leaflet, thereby affecting the effect of the artificial leaflet.

In the first embodiment, each of the adjacent surrounding sutures is independent, and the surrounding sutures are looped around the connecting frame so that the ears of the artificial leaflet closely fit the side posts. And adjacent surrounding suture lines sequentially pass through the valleys on two sides of the wavy suture line, so that the artificial valve leaflet only tearing one side of the wavy suture line around the suture lines is effectively prevented from affecting the performance and the service life of the artificial valve leaflet.

In the second embodiment, the surrounding sutures are formed by one clockwise spirally wound surrounding suture and another counterclockwise spirally wound surrounding suture from top to bottom, compared with the independent surrounding sutures, each spirally wound surrounding suture adopts an integrated spiral surrounding suture, the operation is simple, the fixation is firm, no excessive suture ends exist, the use stability is increased, one of the spiral surrounding sutures does not refer to one suture, and also can be a bundle of sutures, namely a plurality of sutures, and the two sutures sequentially pass through the valleys on two sides of the wavy suture, so that the condition that the connecting frame generates asymmetric force due to the suture, the tearing force is generated on the artificial valve leaflet, and the performance and the service life of the artificial valve leaflet are influenced is prevented.

In one embodiment, the artificial leaflet 2 is provided with ears 403 inclined downward with respect to the upper flat line of the artificial leaflet main body 403 mainly because: in order to further shorten the length of the support, the distance between the position of the connecting frame and the far end of the artificial valve leaflet is shorter than that between the near end of the artificial valve leaflet and the far end of the artificial valve leaflet, so that the distance is shorter, the ear part of the artificial valve leaflet can be smoothly placed into the connecting frame in order to adapt to the shorter support, the downward inclination is needed, and the two ear parts of the artificial valve leaflet which are downward inclined are parallel to each other under the effect of the connecting frame, so that the upper flat line of the main body of the artificial valve leaflet has a bending tendency at the moment, and the mutual closing of the middle parts of the near ends of the adjacent artificial valve leaflets is facilitated.

In one embodiment, as shown in fig. 3-6, the prosthetic leaflet 2 can include a prosthetic leaflet body 404, an ear 403, and an inner concave region 402. In one embodiment, the artificial leaflet main body 404 is provided with a general V shape, but the inner concave regions 402 are provided at both sides of the artificial leaflet main body 404 near the distal end, the main purpose of which is to accommodate the fastening arc protrusion 137 of the fastening member 13, not only the material of the artificial leaflet is small, but also the inner concave regions 402 of the artificial leaflet 2 maintain the same arc direction as the fastening arc protrusion 137 of the fastening member 13. When the stent is compressed, i.e., during the straightening of the fastener 13, the concave region 402 of the artificial leaflet 2 does not exert a large reaction force against the fastening arc convex portion 137 of the fastener 13 to affect the compression of the stent.

In a specific embodiment, referring to fig. 7, the far-end edge of the artificial leaflet main body 404 is provided with an anti-abrasion strip 405, and the anti-abrasion strip 405 is combined with the artificial leaflet main body 404 by sewing, so that the artificial leaflet main body 404 is firmly fixed, and the anti-abrasion strip 405 is arranged to firstly increase the tear resistance of the far end of the artificial leaflet main body 404, secondly reduce the damage of the far end of the artificial leaflet main body 404 and the covering film 3 to the artificial leaflet 2, so as to improve the service life of the artificial leaflet 2, and the arrangement of the anti-abrasion strip 405 is also equivalent to a buffer layer between the artificial leaflet 2 and the covering film 3, so that the tearing acting force of the artificial leaflet 2 on the covering film 3 in the opening and closing process is effectively buffered, and the service life of the self-expanding heart valve stent containing the covering film is prolonged.

In this embodiment, the membrane 3 inside the clamping end 16 is a leakage-proof skirt.

In one embodiment, the distal end of the retaining end 16 is provided with a leakage-proof skirt (not shown), and the outer side of the retaining end 16 is also covered with a film, the distal end of the outer covering film extends to the proximal end of the fastener 13, and the outer covering film of the retaining end 16 can be an inner covering film which is turned outwards or a single covering film, so that the backflow stent is effectively prevented from generating side leakage, and the side leakage prevention performance of the stent is improved.

Next, the structure and features of the self-expanding heart valve stent in the absence of the lattice-like woven covering film in the present embodiment will be described in detail with reference to fig. 12 to 17.

Referring first to fig. 12 and 13, the self-expanding heart valve stent 1 of the present embodiment may include a distal end of the self-expanding heart valve stent close to the apex of the heart when the self-expanding heart valve stent is in the expanded state and a proximal end of the self-expanding heart valve stent far from the apex of the heart when the self-expanding heart valve stent is in the expanded state. The proximal end of the self-expanding heart valve stent may include connectors 14 and positioning members 12 and fasteners 13 disposed between adjacent connectors. The fasteners 13 may be used to secure the prosthetic heart valve leaflets together with the mesh-like woven covering 3. In one embodiment, referring to fig. 12 and 13, the distal end of the self-expanding heart valve stent further comprises a retaining end 16 and a reinforcing mesh 15, and an open structure 17 is arranged between the retaining end 16 and the reinforcing mesh 15. The capture end 16 may include a diamond-shaped structure.

In one embodiment, referring to fig. 12 and 13, the positioning member 12 includes 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 first positioning arm 121 is fixedly connected to a first connecting member, the second positioning arm 122 is fixedly connected to a second connecting member, and the first connecting member is adjacent to the second connecting member. The fastener 13 includes a first fastening arc 131, a second fastening arc 132, and a fastener distal end 133 connecting the first fastening arc 131 and the second fastening arc 132, the first fastening arc 131 is fixedly connected to a first connecting member, the second fastening arc 132 is fixedly connected to a second connecting member, and the first connecting member is adjacent to the second connecting member.

In one embodiment of the first aspect, referring to fig. 16 and 17, in the expanded state of the self-inflating heart valve stent 1, the fastening arcs of the fastening members 13 include fastening arc recessed portions 136 and fastening arc raised portions 137. The fastening arc recessed portion 136 is an arc-shaped rod-like structure that is raised away from the self-expanding heart valve stent, and the distal end of the fastening arc recessed portion 136 is fixedly connected to the fastening arc raised portion 137. The fastening arc protrusion 137 is an arc-shaped rod-like structure protruding toward the self-expanding heart valve stent. The distal ends of the fastening arc protrusion portions 137 connect adjacent fastening arc protrusion portions 137 by the fastener distal ends 133. By such a design, the fastener distal end is made less open, preventing the prosthetic valve leaflet from opening too far into the native valve leaflet region. Secondly, the fastener 13 may be composed of two and/or three segments (for example, a linear segment is added between the concave portion 136 of the fastening arc and the convex portion 137 of the fastening arc), etc., and the fastener 13 composed of two segments obviously shows that the opening angle of the distal end of the fastener 13 relative to the convex portion 137 of the fastening arc is smaller, so that the change angle of the convex portion 137 of the fastening arc at the distal end of the fastener 13 is small in the process of compressing and expanding, although the nickel-titanium alloy has super elasticity, the too large compression expansion deformation still affects the performance of the nickel-titanium alloy, so that the deformation degree of the nickel-titanium alloy is reduced, the self-expansion performance of the nickel-titanium alloy can be better, and the self-expansion of the self-expanding heart valve stent is facilitated.

In one embodiment, referring to fig. 13, 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 so as to facilitate compression, and when the first positioning arm and the second positioning arm are fully compressed, the occupied space is minimum, and the linear structure can ensure that the first positioning arm and the second positioning arm do not interfere with each other. In addition, the stent is formed by cutting a nickel-titanium tube, but 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 positioning member 12 has a parabolic structure, which reduces the contact stress between the positioning member 12 and the sinus floor and prevents the valve annulus from cracking.

In one embodiment, the width of the fastener 13 is wider than the width of the support member 11 and the positioning member 12 to provide strong support.

In one embodiment, the positioning member 12 has a second opening angle when the heart valve stent is in the expanded state, the second opening angle is 4-14 °, and the first opening angle is smaller than the second opening angle. The second opening angle can preferably be 4 °, 6 °, 7 °, 8 °, 9 °, 12 °, 13 ° or 14 °. The positioning member 12 and the fastening member 13 form a certain opening angle, so that the positioning member 12 can catch the valve leaflets conveniently, and the operation difficulty is reduced. The positioning piece 12 can be used for preventing the valve ventricle from displacing, enabling the far end of the artificial valve leaflet to be aligned with the native valve leaflet, enabling the artificial valve leaflet to restore the native valve to the maximum extent, and meanwhile, keeping the artificial valve leaflet to be located at the position of the original native valve, so that the artificial valve leaflet well replaces the native valve, the influence on blood flow is reduced, and the occurrence of thrombus is reduced, and the positioning piece 12 and the fastener 13 can clamp the native valve to prevent the native valve from moving freely due to the arrangement of the second opening angle of 4-14 degrees, and meanwhile, the native valve leaflet is tightly attached to the support, so that the perivalvular leakage is reduced.

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 4mm to 8mm, preferably 6mm, from the distal-most portion of the heart valve stent (i.e., the capture end 16 described below).

In one embodiment, the distal end of the station end 16 is flared proximally relative to the station end 16, and the distal end of the station end 16 is flared proximally at an angle of 6 ° to 14 ° relative to the station end 16. The reason for the need for flaring is to prevent the lightweight heart valve stent from displacing towards the aorta and serving as an anchoring function. At the same time, the reason why the excessive angle cannot be generated is to prevent the his bundle from being touched, thereby affecting the normal beating of the heart and endangering life.

In the present embodiment, the number of the diamond-shaped squares of the retaining end 16 is 18, which effectively increases the compressibility of the heart valve stent, and the widths of the rods constituting the diamond-shaped squares are gradually changed (the width of the middle is thin and the width of the two ends are wide), so as to optimize the fatigue resistance of the stent, and simultaneously enhance the resilience effect of the retaining end 16, which facilitates the self-expansion of the stent. In addition, because the heart valve support only comprises 18 diamond-shaped grids, only one reinforcing net 15 is needed to connect the clamping end 16 between the adjacent fastening arcs of the heart valve support, a large number of hollowed-out parts can be formed, the weight of the heart valve support is effectively reduced, the heart valve support is convenient to compress, and the rod width of the diamond-shaped grids is gradually changed (the middle part is thin and the two ends are wide) so as to optimize the fatigue resistance of the support. In addition, the presence of the reinforcing mesh 15 may both increase the central structural strength of the stent and isolate the native valve leaflets to prevent invasion of the artificial valve leaflets.

Next, further technical features of the reinforcing mesh 15 are described in more detail.

In another embodiment, referring to fig. 12-14, a reinforcing mesh 15 is disposed between the capture end 16 and the fasteners 13, a distal end of the reinforcing mesh 15 being secured to the capture end 16, and a proximal end of the reinforcing mesh 15 being fixedly attached between different fastening arcs of adjacent fasteners 13.

In a preferred embodiment, the reinforcing mesh 15 comprises a plurality of interconnected reinforcing mesh structural units 151, the reinforcing mesh structural units 151 on one side of the proximal end of the reinforcing mesh 15 being fixedly connected to the second fastening arcs of the first fastening members, and the reinforcing mesh structural units 151 on the other side of the proximal end of the reinforcing mesh 15 being fixedly connected to the first fastening arcs of the second fastening members. In other words, the proximal ends of the reinforcing mesh 15 are respectively connected to different fastening arcs of different fasteners, thereby achieving a fixed connection.

In a preferred embodiment, the reinforcing mesh 15 comprises three layers connected to each other in sequence along the axial direction from the proximal end of the heart valve stent to the distal end of the heart valve stent, wherein the first layer comprises one reinforcing mesh structure unit 151, the second layer comprises two reinforcing mesh structure units 151, and the third layer comprises one reinforcing mesh structure unit 151. The reinforcing mesh structural unit 151 of the first layer shares one side with the second fastening arc of the fastener on its left, and shares one side with the first fastening arc of the fastener on its right. The reinforcing mesh structure unit 151 on the left side of the second layer shares one edge with the second fastening arc of the fastener 13 on the left side thereof, and the reinforcing mesh structure unit 151 on the right side of the second layer shares one edge with the first fastening arc 111 of the fastener 13 on the right side thereof. The reinforcing mesh structure units 151 of the third layer share a vertex with the clamping end structure units. In this embodiment, the reinforcing mesh structural unit attachment regions 154 of the second layer of reinforcing mesh extend a predetermined length along the circumferential and longitudinal directions of the self-inflating heart valve stent, respectively. In one embodiment, the width of the rods 152 forming the reinforcing mesh structure unit 151 is smaller at the center and larger at the ends, similar to the rods forming the detent end structure unit 161.

Next, more technical features of the card terminal 16 will be described in more detail.

In one embodiment, and referring first to FIG. 15, a self-expanding heart valve stent 1 may include a retaining end 16, the retaining end 16 including a plurality of retaining end structural units 161 connected to one another, the rods 162 comprising the retaining end structural units 161 having a width that is smaller at the center and larger at the ends. In the embodiment shown in fig. 15, the lever 162 of the locking end structure unit 161 may be symmetrical, having a minimum width in the middle and then becoming larger smoothly toward both ends without a stepwise abrupt change. The edges of the bar 162 are smooth. The connecting rod at the clamping end adopts the design of thin middle part and thick two ends, the fatigue resistance of the bracket is optimized, but the radial supporting force of the clamping end can be influenced if the middle position is too thin. Therefore, the fatigue resistance of the clamping end of the bracket needs to be optimized on the basis of ensuring the radial supporting force of the clamping end, so that the minimum width X of the connecting rod at the clamping end is controlled within the range of 0.53-0.93 times of the maximum width Y.

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 interconnected by sharing a vertex. Adjacent ones of the retaining end structural unit connection regions 164 extend a predetermined length circumferentially and longitudinally of the lightweight heart valve stent, respectively.

Next, the structure of the connecting member 14 of the present embodiment will be described in more detail. Returning to fig. 12-13, 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 proximal end of the heart valve stent, and the other end is connected with the connecting frame 143 through the connecting web 142, and the connecting block 141 is for connecting with a conveyer for conveying the heart valve stent. The connecting frame 143 may in turn comprise a positioning member connecting portion and a fastener connecting portion in a direction from the proximal end of the heart valve stent to the distal end of the heart valve stent. One end of the elongated suture hole 144 may be provided at the retainer connecting portion and the other end at the fastener connecting portion.

In one embodiment, the width of the connection web 142 is less than the width of the connection block 141. In another embodiment, the connecting frame 143 includes a hollow elongated suture hole 144. One end of the elongated suture hole 144 may be provided at the positioner connecting portion and the other end at the fastener connecting portion. The long-strip-shaped sewing hole 144 can realize that the near-end edge of the artificial valve leaflet 2 directly passes through the sewing hole to be sewn, and does not need to increase the sewing gasket, the edge of the artificial valve leaflet 2 is sewn with the fastening arc, and the sewing mode is relatively traditional, and the mode of using the gasket and extruding the fixed valve leaflet by the support is adopted, so that the external additional parts of the support are firstly reduced, and the gasket is not provided, so that the support is favorable for further compression, if the gasket exists, not only the support compression is influenced, and even the artificial valve leaflet 2 can be damaged under the condition that the support compression support is small.

In another embodiment, the positioning member 12 can include a pull wire composite ring 124, the pull wire composite ring 124 is fixedly connected to the positioning member 12 and is located on a side of the positioning member 12 facing the proximal end of the heart valve stent, the pull wire composite ring 124 includes a first through hole 1241 and a second through hole 1242, the first through hole 1241 is used for installing a marker, the second through hole 1242 is suitable for threading a pull wire, 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 structure arranged at the far end of the positioning member 12 combines the installation of the pull wire and the mark 'marker' (the mark is radiopaque) into a position, and effectively reduces the space occupation rate of the product. Utilize a position, can realize opening and shutting control and the location of setting element, not only improved the compression performance of product, do benefit to the product and use the pipe to carry, the setting element can open moreover and still do benefit to the degree of difficulty that reduces the operation. Stay wire composite ring structure has two through-holes, the macropore is in order to place the marker point, so that implant accurate location, ensure that the setting element touches the sinus bottom, the aperture conveniently penetrates the stay wire, but it states to be, it adopts the aperture to shake and influence the accuracy of operation setting element in order to guarantee to stay wire can no longer the aperture, so the diameter in stay wire hole is less than macroporous diameter and is preferred, but also do not get rid of, the diameter in stay wire hole equals or is greater than the condition of macropore diameter, in the implantation in-process, through the control setting element opening angle of acting as go-between, conveniently catch the leaflet, reduce the operation degree of difficulty. In a preferred embodiment, the pull wire composite ring is arranged at the distal end of the positioning part and is inclined inwards relative to the axis of the stent, so that the proximal end of the pull wire composite ring is prevented from colliding with the wall of the aorta during the shaking process of the stent, the aorta is damaged, and the aortic dissection of a user can be seriously caused, so that the life of the user is threatened. So that the positioning piece can be pulled to the outside of the heart valve stent through the pull wire.

In the embodiment shown in the drawings, the heart valve stent may comprise 3 positioning members, fasteners and connectors which are structurally identical. The adjacent connecting pieces are connected through the positioning piece and the fastening piece. Meanwhile, the adjacent positioning pieces and the fastening pieces are connected through the connecting pieces.

By eliminating the support, the proximal end of the spacer 12 is connected to the proximal end of the connecting frame 143, or the proximal end of the spacer is connected to the distal end of the connecting web 142, and the connection of the spacer 12 to the connecting web 142 forms the proximal end of the connecting frame 143. Above-mentioned structural design is because cancelled the support piece, so the position that is closer to this backflow support proximal end that the proximal end of setting element can set up, and then increased the distance of setting element proximal end to distal end, increased the space of setting element 12 clamp native valve leaflet promptly, so when the native valve leaflet of the great main (lung) artery of face, setting element 12 can not be because of native valve leaflet's the unable sinus floor that inserts, the setting element distal end can be abundant insert the sinus floor, the distal end that has prevented setting element 12 is because of unable insert the sinus floor and cause this backflow support to take place the displacement under the great pressure differential that produces during cardiac ventricle diastole, make the setting element 12 distal end can impact the condition appearance at the sinus floor, and cause the sinus floor injury.

Example 2

Example 2 differs from example 1 in that the proximal end of the self-expanding heart valve stent further comprises a support 11.

Referring to fig. 18-21, the proximal end of the self-expanding heart valve stent of the present embodiment further includes a support member 11, the support member 11 being disposed between adjacent connecting members 14. The support 11 may include 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, the first support arm 111 being fixedly connected to a first connector, the second support arm 112 being 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 self-expanding heart valve stent than the support member 11, and the fastener 13 is closer to the distal end of the self-expanding heart valve stent than the positioning member 12. The distal ends of the support 11 and the positioning member 12 are rods projecting toward the distal end of the self-expanding heart valve stent. In this embodiment, the support 11 may be provided on one side of the native heart valve leaflets and the positioning member 12 on the other side of the native heart valve leaflets for clamping the native leaflets. The support 11 can clamp the native heart valve leaflets together with the positioning member 12, avoiding intrusion of the prosthetic heart valve leaflets.

Unlike embodiment 1, the connection frame 143 of the present embodiment further includes a support connection part that is closer to the connection block 141 than the positioning member connection part. In one embodiment, the support member connecting portion may be symmetrical, and one side of the support member connecting portion is connected to the first support arm of the first support member and the other side of the support member connecting portion is connected to the second support arm of the adjacent second support member. In a preferred embodiment, the upper edge of the support arm at the junction with the connecting frame 143 is a smooth arc with an angle of 100 ° to 160 °. Meanwhile, the lower edge of the joint of the support arm and the connecting frame 143 is also a smooth arc, and the angle of the arc is an acute angle.

In one embodiment, the support arm of the support member includes an X-point at which the first support arm or the second support arm is bent, the point of deformation being away from the connecting frame, reducing stress concentrations. Since the support member and the positioning member are coupled to the coupling frame 143 and the space of the coupling frame 143 is limited, if the support member coupling portion and the positioning member coupling portion of the coupling frame are located in close proximity. If the deformation position of the support piece relative to the connecting frame and the deformation position of the positioning piece relative to the connecting frame are both at the joint, and the support piece and the positioning piece are respectively positioned at two sides of the valve, if the deformation positions of the support piece and the positioning piece relative to the connecting frame are too close, large shearing force is easily generated on a native valve close to the connecting frame, so that the valve is injured, and the deformation area is too close, stress concentration is also easily generated, and the joint of the support piece/the positioning piece and the connecting frame is broken. At this time, the distance between the support member and the connecting frame relative to the deformation position of the connecting frame needs to be increased, so that the cross sectional area of the support member and the cross sectional area of the connecting frame are increased, the streamline of the support member and the streamline of the connecting frame are maintained, the support is convenient to release, the upper edge of the connecting part of the support arm and the connecting frame is a smooth arc line, the angle of the arc line is 100-160 degrees, the lower edge of the connecting part of the support arm and the connecting frame is also a smooth arc line, and the angle of the arc line is an acute angle, so that a stress concentration releasing arc is formed at the connecting part of the positioning member and the connecting frame on the lower side, a stress concentration point is prevented from being formed, and the connecting part of the support member/the positioning member and the connecting frame is prevented from being broken. In the heart valve stent described herein, the shift of the deformed position of the support with respect to the connecting frame to the X point away from the connecting frame solves the problem of easily generating a large shearing force to the native valve close to the connecting frame, and the position of the two deformed regions becomes distant, also preventing the problem of excessive stress concentration.

In one embodiment, the width of the connection web 142 is less than the width of the connection block 141 and less than the width of the connection portion of the supporter. In another embodiment, the connecting frame 143 includes a hollow elongated suture hole 144. The elongated suture holes 144 may be provided at one end thereof at the support connection part and at the other end thereof at the keeper connection part or the fastener connection part. The elongated suture hole 144 can realize that the proximal edge of the artificial heart valve leaflet directly passes through the suture hole to be sutured without adding a suture gasket, and the edge of the artificial heart valve leaflet is sutured with a fastening arc.

Referring to fig. 21, in one embodiment, the retaining end structure unit 161 is a diamond grid, and the retaining end 16 may include a plurality of 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. Adjacent ones of the retaining end structural unit connecting regions 164 extend a predetermined length circumferentially and longitudinally of the self-expanding heart valve stent, respectively, and in the circumferential direction of the self-expanding heart valve stent, the adjacent retaining end structural unit connecting regions 164 include curved structures 163 that are concave toward them. Since the ends of the rod 162 are widest and are widest near the latch end unit attachment area 164 and are most difficult to deform, the rod 162 is subject to greater stresses during compression and expansion, which tends to cause the rod 162 to break near the latch end unit attachment area 164. By adding the bending structure 163, the bending stress of the rod 62 at the position close to the clamping end structure unit connecting region 164 is reduced, the rod 162 can be prevented from being broken during the compression and self-expansion processes of the clamping end of the self-expanding heart valve stent, and meanwhile, the bending structure 163 can ensure that when the stent is used for suturing the membrane, the suture can be fixed at the bending structure 163, and the suture can be prevented from sliding on the clamping end structure unit to influence the fixation of the membrane.

The features of the covering film 3, the artificial valve leaflet 2, the positioning member 12, the fastening member 13, the reinforcing mesh 15, and other structures not specifically described in this embodiment are the same as those of embodiment 1, and refer to the description of embodiment 1.

It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.

Claims

1. A self-expanding cardiac valve stent containing a cover, comprising a self-expanding cardiac valve stent distal end that is close to an apex of a heart when the self-expanding cardiac valve stent is in an expanded state and a self-expanding cardiac valve stent proximal end that is far from the apex of the heart when the self-expanding cardiac valve stent is in an expanded state, characterized in that the self-expanding cardiac valve stent containing a cover comprises a flexible lattice-like woven cover that is fixed inside the self-expanding cardiac valve stent distal end containing a cover for fixing a prosthetic leaflet;

2. The self-expanding heart valve stent including a covering membrane of claim 1, wherein the first and second fastening arcs of the fastener comprise, when the self-expanding heart valve stent is in an expanded state:

3. The self-expanding cardiac valve stent comprising a cover of claim 1, wherein the lattice-woven cover is woven from longitudinal threads and transverse threads, the angle between the longitudinal threads and the transverse threads being set at 60 ° to 90 °.

4. The self-expanding cardiac valve stent including a cover of claim 1, wherein the lattice-weave cover is secured to the self-expanding cardiac valve stent including a cover by sewing with the components of the self-expanding cardiac valve stent including a cover;

the far end of the self-expanding heart valve stent containing the covering film comprises a clamping end, the clamping end comprises diamond structures which are connected with each other, and the longitudinal lines of the latticed woven covering film and one of the connecting rods of the diamond structures are fixed on the self-expanding heart valve stent in parallel.

5. The self-expanding cardiac valve stent comprising a cover of claim 4, wherein the distal end of the capture end is provided with a capture-end outer cover that acts as a leak-proof skirt, the capture-end outer cover distal end up to the proximal end of the fastener.

6. The self-expanding heart valve stent comprising a cover of claim 5, wherein the capture end outer cover is an inner cover everted to the outside or a single cover.

7. The self-expanding heart valve stent containing a covering film according to any one of claims 1 to 6, further comprising an artificial leaflet including an artificial leaflet main body and an ear, the outer contour of the artificial leaflet main body including a concave region that is concave toward the artificial leaflet;

8. The self-expanding cardiac valve stent containing a covering film according to claim 7, wherein the proximal end of the prosthetic leaflet is fixed to the connecting piece of the self-expanding cardiac valve stent containing a covering film by means of wavy sutures or around sutures.

9. The self-expanding stent-graft-containing heart valve of claim 8, wherein the proximal end of the prosthetic leaflet is secured to the attachment member of the stent-graft-containing heart valve by surrounding sutures, each adjacent surrounding suture being free-standing and the surrounding sutures being looped around the attachment frame such that the ears of the prosthetic leaflet fit snugly against the side posts of the attachment frame.

10. The stent of claim 8, wherein the proximal end of the prosthetic leaflet is secured to the attachment member of the stent by way of a surrounding suture formed from one clockwise spirally wound surrounding suture and another counterclockwise spirally wound surrounding suture, each spirally wound surrounding suture being an integral spiral surrounding suture relative to the separate surrounding suture.

11. The self-expanding covered heart valve stent of claim 8, wherein the proximal end of the artificial leaflet is fixed to the connecting member of the self-expanding covered heart valve stent by wavy sutures, the ear of the artificial leaflet passes through the connecting frame and passes around the side posts of the connecting frame to make the tail end of the ear return to the inside of the self-expanding covered heart valve stent and fit with the artificial leaflet at the junction of the artificial leaflet main body and the ear, and the tail end of the artificial leaflet is tightly combined with the artificial leaflet by passing the wavy sutures through the artificial leaflet of the same connecting frame, and the main body of the adjacent artificial leaflet is tightly combined with the ear junction, so that the fixation of the artificial leaflet and the tight combination of the adjacent artificial leaflet at the side close to the stent are realized.

12. The self-expanding heart valve stent including a covering membrane of claim 7, wherein the prosthetic leaflet further comprises an anti-wear bead disposed on an outer contour of the prosthetic leaflet body.

13. The self-expanding cardiac valve stent comprising a covering membrane according to claim 7, wherein the artificial leaflet has ears disposed at a downward inclination with respect to a superior flat line of the artificial leaflet body.

14. The self-expanding heart valve stent including a covering of claim 7, wherein the lattice-woven covering is woven from a PET material and has a thickness less than a thickness of the prosthetic leaflet.