Self-expanding heart valve stent with a membrane

Abstract

The present invention discloses a self-expanding heart valve stent including a membrane, which includes a flexible mesh-shaped woven membrane, wherein the flexible mesh-shaped woven membrane is fixed to the inner side of the distal end of the self-expanding heart valve stent including the membrane, and is used to fix the artificial valve leaflet; the proximal end of the self-expanding heart valve stent includes a connector and a fastener arranged between adjacent connectors, and the fastener is used to fix the artificial heart valve leaflet together with the mesh-shaped woven membrane. A membrane is provided between the artificial valve leaflet and the self-expanding heart valve stent to facilitate compression of the self-expanding heart valve stent, so that the artificial valve leaflet can be applied to self-expanding heart valve stents of different sizes, thereby increasing the versatility of the artificial valve leaflet. In addition, the artificial valve leaflet body described herein is provided with concave areas on both sides near the distal end, that is, the artificial valve leaflet uses less material and has a larger space to accommodate the material extruded during the extrusion process, so that in the process of the fastener straightening, no excessive extrusion will occur to the suture position of the valve leaflet.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a self-expanding heart valve stent comprising a membrane. Background Art

[0002] Due to its numerous advantages, such as minimal invasiveness and rapid recovery, transcatheter surgery is increasingly being used. Aortic valve replacement has evolved from an early surgical approach to a transcatheter approach. Heart valve stents are crucial medical devices for aortic valve replacement.

[0003] The conventional method of suturing artificial valve leaflets to a self-expanding heart valve stent including a membrane is to sew the artificial valve leaflets and the self-expanding heart valve stent including a membrane, for example, by fastening the arc. However, the surface of the fastening arc is smooth, so the artificial valve leaflets are not firmly fixed. The fastening arc needs to be set into a curved shape, or fixing holes need to be added. In order to ensure the strength of the fastening arc, the width of the fastening arc is increased, which increases the volume of the self-expanding heart valve stent including a membrane for regurgitation, making it difficult to compress the self-expanding heart valve stent including the membrane, and failing to achieve the desired compression of the self-expanding heart valve stent including the membrane.

[0004] Since the diameter of the self-expanding heart valve stent that needs to be compressed is small, the material thickness and width are greatly limited. Therefore, it is hoped that the self-expanding heart valve stent including the coating will not be disturbed by excessive external forces during compression, such as the force from the coating.

[0005] Therefore, there is a continuous need in the art to develop a self-expanding heart valve stent including a membrane that is easy to compress. Summary of the Invention

[0006] The present application aims to provide a self-expanding heart valve stent with a membrane that is easily compressible and highly versatile for artificial valve leaflets. Specifically, the self-expanding heart valve stent described herein includes a flexible, woven mesh membrane secured to the inner distal end of the self-expanding heart valve stent to secure the artificial valve leaflets. This provides a buffer between the artificial valve leaflets and the stent, accommodating self-expanding heart valve stents of varying sizes and enhancing the versatility of the artificial valve leaflets. It also enhances the seal between the stent and the aortic wall, preventing lateral blood leakage.

[0007] To achieve the above objectives, the present invention provides the following technical solutions.

[0008] In a first aspect, the present application provides a self-expanding heart valve stent including a membrane, comprising a distal end of the self-expanding heart valve stent close to the apex when the self-expanding heart valve stent is in an expanded state, and a proximal end of the self-expanding heart valve stent away from the apex when the self-expanding heart valve stent is in an expanded state, characterized in that the self-expanding heart valve stent including the membrane includes a flexible mesh-like braided membrane, and the flexible mesh-like braided membrane is fixed to the inner side of the distal end of the self-expanding heart valve stent including the membrane, and is used to fix the artificial valve leaflet;

[0009] The proximal end of the self-expanding heart valve stent includes a connector and a fastener arranged between adjacent connectors, the fastener is used to fix the artificial heart valve leaflet together with the grid-like woven covering, the fastener includes a first fastening arch, a second fastening arch and a fastener distal end connecting the first fastening arch and the second fastening arch, the first fastening arch is fixedly connected to the first connector, the second fastening arch is fixedly connected to the second connector, and the first connector is adjacent to the second connector.

[0010] In one embodiment of the first aspect, when the self-expanding heart valve stent is in an extended state, the first fastening arch and the second fastening arch of the fastener include:

[0011] A fastening arc recessed portion, wherein the fastening arc recessed portion is an arc-shaped rod-shaped structure that protrudes in a direction away from the self-expanding heart valve stent and simultaneously protrudes toward the proximal end of the self-expanding heart valve stent;

[0012] A fastening arc convex portion, wherein the fastening arc convex portion is an arc-shaped rod-shaped structure that convexes toward the self-expanding heart valve stent and simultaneously convexes toward the distal end of the self-expanding heart valve stent;

[0013] The proximal end of the fastening arc recessed portion is connected to the connector, the distal end of the fastening arc recessed portion is fixedly connected to the fastening arc convex portion, and the distal end of the fastening arc convex portion is connected to the adjacent fastening arc convex portion through the distal end of the fastener.

[0014] In one embodiment of the first aspect, the grid-like woven membrane is woven from longitudinal lines and transverse lines, and the angle between the longitudinal lines and the transverse lines is set to 60° to 90°.

[0015] In one embodiment of the first aspect, the mesh-like braided membrane is fixed to the self-expanding heart valve stent including the membrane by suturing the components of the self-expanding heart valve stent including the membrane;

[0016] The distal end of the self-expanding heart valve stent including the membrane includes a locking end, which includes interconnected diamond structures. The longitudinal lines of the grid-like braided membrane are fixed to the self-expanding heart valve stent in parallel with one of the connecting rods of the diamond structure.

[0017] In one embodiment of the first aspect, the distal end of the locking end is provided with a locking end outer covering film serving as a leak-proof skirt, and the distal end of the locking end outer covering film extends all the way to the proximal end of the fastener.

[0018] In one embodiment of the first aspect, the outer covering of the locking end is an inner covering turned outward, or is a single covering.

[0019] In one embodiment of the first aspect, the self-expanding heart valve stent including the membrane further includes an artificial valve leaflet, wherein the artificial valve leaflet includes an artificial valve leaflet body and an ear portion, and the outer contour of the artificial valve leaflet body includes a concave area that is concave toward the artificial valve leaflet;

[0020] The connecting member includes a connecting block, a connecting web, and a connecting frame. One end of the connecting block forms the proximal end of the self-expanding heart valve stent containing the membrane, and the other end is connected to the connecting frame through the connecting web. Along the direction from the proximal end of the self-expanding heart valve stent containing the membrane to the distal end of the self-expanding heart valve stent containing the membrane, the connecting frame sequentially includes a positioning member connecting portion and a fastener connecting portion.

[0021] The proximal end of the artificial valve leaflet is fixed to the connector of the self-expanding heart valve stent containing the covering, and the distal end of the artificial valve leaflet is fixedly connected to the mesh-like braided covering across the fastening arc of the fastener.

[0022] In one embodiment of the first aspect, the proximal end of the artificial valve leaflet is fixed to the connector of the self-expanding heart valve stent including the membrane by a wavy suture or by surrounding the suture.

[0023] In one embodiment of the first aspect, the proximal end of the artificial valve leaflet is fixed to the connector of the self-expanding heart valve stent containing the membrane by means of a surrounding suture, each adjacent surrounding suture is independent, and the surrounding suture surrounds the connecting frame so that the ear of the artificial valve leaflet fits tightly against the side column of the connecting frame.

[0024] In one embodiment of the first aspect, the proximal end of the artificial valve leaflet is fixed to the connector of the self-expanding heart valve stent containing the membrane by means of a surrounding suture, and the surrounding suture is formed from top to bottom by a clockwise spirally wound surrounding suture and another counterclockwise spirally wound surrounding suture. Compared with the above-mentioned independent surrounding sutures, each spirally wound surrounding suture adopts an integrated spiral surrounding suture.

[0025] In one embodiment of the first aspect, the proximal end of the artificial valve leaflet is fixed to the connector of the self-expanding heart valve stent containing the membrane by means of a wavy suture line, and the ear of the artificial valve leaflet passes through the connecting frame and bypasses the side column of the connecting frame so that the tail end of the ear returns to the interior of the self-expanding heart valve stent containing the membrane, and fits with the artificial valve leaflet at the connection between the artificial valve leaflet body and the ear. The wavy suture line passes through the artificial valve leaflet located on the same connecting frame, tightly combines the tail end of the ear of the artificial valve leaflet with the artificial valve leaflet, and tightly fits the connection between the body and the ear of the adjacent artificial valve leaflet, thereby achieving the fixation of the artificial valve leaflet and the tight combination of the adjacent artificial valve leaflets close to the stent side.

[0026] In one embodiment of the first aspect, the artificial valve leaflet further includes an anti-wear edge strip, and the anti-wear edge strip is arranged on the outer contour of the artificial valve leaflet body.

[0027] In one embodiment of the first aspect, the ear portion of the artificial valve leaflet is inclined downward relative to an upper horizontal line of the artificial valve leaflet body.

[0028] In one embodiment of the first aspect, the grid-shaped woven membrane is woven from PET material, and its thickness is less than the thickness of the artificial valve leaflet.

[0029] Compared with the prior art, the present invention has the following advantages:

[0030] 1) A membrane is provided between the artificial valve leaflet and the self-expanding heart valve stent. Compared to an integrated artificial valve leaflet, the current artificial valve leaflet is combined with a thinner membrane to form an artificial valve leaflet as a whole, which facilitates compression of the self-expanding heart valve stent. At the same time, the artificial valve leaflet is sutured to the membrane, which is more flexible than the method of fixing it to the stent. Because the fastener shapes of stents of different sizes after expansion are different, the artificial valve leaflet is sewn to the membrane, so that artificial valve leaflets of the same geometric shape (the valve leaflet can be enlarged or reduced in proportion without changing the geometric shape characteristics) can be flexibly adapted to self-expanding heart valve stents of different sizes, increasing the versatility of the artificial valve leaflet.

[0031] 2) Concave areas are provided on both sides of the artificial valve leaflet body near the distal end, i.e., the artificial valve leaflet uses less material, and the concave areas maintain the same arc direction as the convex portion of the fastening arc of the fastener. When the stent is compressed, i.e., when the fastener is straightened, the concave areas of the artificial valve leaflet will not generate a large reaction force on the convex portion of the fastening arc to affect the compression of the stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The technical features and advantages of the present invention will be more fully understood by referring to the following detailed description in conjunction with the accompanying drawings.

[0033] Figure 1A perspective view showing a self-expanding heart valve stent including a mesh-shaped braided cover in an expanded state after installation of the cover according to another embodiment.

[0034] Figure 2 A perspective view showing a self-expanding heart valve stent including a membrane in an expanded state after installation of an artificial valve leaflet according to yet another embodiment.

[0035] Figure 3 A schematic diagram showing a mesh-like woven covering according to one embodiment.

[0036] Figure 4 A schematic diagram shows a prosthetic valve leaflet according to one embodiment.

[0037] Figure 5 show Figure 4 A partial enlarged view of the concave area in .

[0038] Figure 6 A schematic diagram shows a prosthetic valve leaflet according to another embodiment.

[0039] Figure 7 A schematic diagram shows a prosthetic valve leaflet according to another embodiment.

[0040] Figure 8 A perspective view showing a self-expanding heart valve stent including a membrane in an expanded state after installation of an artificial valve leaflet according to yet another embodiment.

[0041] Figure 9 show Figure 8 A partial enlarged view of area A in the middle.

[0042] Figure 10 A perspective view showing a self-expanding heart valve stent including a membrane in an expanded state after installation of an artificial valve leaflet according to yet another embodiment.

[0043] Figure 11 show Figure 10 A partial enlarged view of area A in the middle.

[0044] Figure 12 show Figure 1 Schematic diagram of a self-expanding heart valve stent without a mesh braided cover.

[0045] Figure 13 show Figure 12 An expanded view of the self-expanding heart valve stent is shown.

[0046] Figure 14 show Figure 13 A partial enlarged view of area A in the middle.

[0047] Figure 15 show Figure 13 A partial enlarged view of area B in the middle.

[0048] Figure 16 A schematic diagram showing a self-expanding heart valve stent without a mesh-like braided cover according to another embodiment.

[0049] Figure 17A show Figure 16 A partial enlarged view of the middle area F.

[0050] Figure 17B A schematic diagram showing the fasteners.

[0051] Figure 18 A schematic diagram showing a self-expanding heart valve stent without a mesh-like braided cover according to another embodiment.

[0052] Figure 19 show Figure 18 An expanded view of the self-expanding heart valve stent is shown.

[0053] Figure 20 show Figure 18 A partial enlarged view of area B in the middle.

[0054] Figure 21 show Figure 18 A partial enlarged view of area C in the middle. DETAILED DESCRIPTION

[0055] Unless otherwise defined, technical or scientific terms used in this specification and claims shall have the same general meaning as understood by persons having ordinary skills in the technical field to which the present invention belongs.

[0056] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be understood as limiting the present invention.

[0057] Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the technical features being referred to. Thus, a feature identified with "first," "second," etc., may explicitly or implicitly include one or more of such features. In the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0058] In the description of the present invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood in a broad sense. For example, they may refer to connection, detachable connection, or integral connection; mechanical connection or electrical connection; direct connection or indirect connection through an intermediate medium; or internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on specific circumstances.

[0059] As described herein, when describing the heart valve stent, "proximal end" refers to the side of the delivery device or the side in the direction of the end manipulated by the user when the heart valve stent is in the extended state. Accordingly, "distal end" refers to the side away from the delivery device or the side in the direction of the end manipulated by the user when the heart valve stent is in the extended state. In this application, when describing the heart valve stent, "proximal end" refers to the side close to the apex of the heart when the heart valve stent is in the extended state. Accordingly, "distal end" refers to the side away from the apex of the heart when the heart valve stent is in the extended state. Because the heart valve stent described herein is delivered by catheter through the aorta, the distal end and the proximal end refer to the same position, and the proximal end and the distal end refer to the same position, but this does not exclude the use of a transapical approach for implantation. It is just that this article describes the case where the heart valve stent is delivered by catheter through the aorta as an example.

[0060] Example 1

[0061] This embodiment relates to a self-expanding heart valve stent including a membrane. A flexible, woven mesh membrane is disposed between the prosthetic valve leaflets and the connector of the self-expanding heart valve stent. The woven mesh membrane is fixedly attached to the inner side of the distal end of the heart valve stent. The proximal end of the prosthetic valve leaflet can be sutured to the connector of the proximal end of the self-expanding heart valve stent, while the distal end can be fixedly attached to the woven mesh membrane. The membrane is relatively flexible and allows a certain degree of displacement, so it does not exert strong tearing forces on the prosthetic valve leaflet, ensuring the safety of the prosthetic valve leaflet and increasing its versatility.

[0062] Conventional heart valve stents are typically covered with a woven PET material, with the woven patterns typically being horizontal and vertical. That is, the horizontal and vertical lines of the woven PET fabric are perpendicular to each other at 90°. During suturing, the vertical lines of the woven PET fabric are parallel to the axis of the self-expanding heart valve stent including the covering, while the horizontal lines are parallel to the circumferential direction of the self-expanding heart valve stent including the covering. Therefore, during compression of the self-expanding heart valve stent including the covering, the covering and the stent are fixed. Therefore, the longitudinal length of the PET woven fabric is fixed, while the self-expanding heart valve stent with a membrane will grow during compression. In particular, the length of the upper and lower connecting points of the connecting rods of the diamond-shaped structure at the locking end will increase, while the longitudinal lines (hereinafter referred to as "longitudinal lines") that secure the PET membrane to the membrane will not grow. Therefore, the longitudinal lines will prevent the diamond-shaped structure at the locking end from compressing and lengthening. As a result, the diamond-shaped structure continues to compress under the action of external forces, while the longitudinal lines continue to prevent compression. Therefore, the diamond-shaped structure at the locking end is easily deformed and damaged by the combined forces of compression and compression resistance. However, it should be noted that the compression resistance force generated by the conventional horizontal and vertical PET membrane acts not only on the diamond-shaped structure at the locking end, but also on the diamond-shaped structure of the reinforcement mesh and the fasteners, blocking the compression of both, thereby affecting the compression of the entire stent. In fact, the force generated by the membrane to prevent the self-expanding heart valve stent with a membrane can even damage the entire stent during compression.

[0063] refer to Figure 1 and Figure 2 In one embodiment, the self-expanding heart valve stent with a membrane is coated with a woven PET mesh. The membrane 3 can be sutured to the various components of the self-expanding heart valve stent. Due to the intricate structure of the self-expanding heart valve stent, the membrane can be securely fixed to the inner side of the self-expanding heart valve stent. Since the size of the self-expanding heart valve stent varies, if the prosthetic valve leaflets are directly sewn to the self-expanding heart valve stent, the shape of the fasteners after expansion will vary between stents of different sizes. Therefore, as the self-expanding heart valve stent changes, the size and shape of the prosthetic valve leaflets will also need to change accordingly, reducing the versatility of the prosthetic valve leaflets and increasing costs. If only the size of the prosthetic valve leaflets is changed to adapt to stents of different sizes, the performance parameters of the prosthetic valve leaflets will inevitably not meet standard requirements. Therefore, if the prosthetic valve leaflets are fixed to the stent, changing the stent size will require changing the size and shape of the prosthetic valve leaflets, requiring redesign to meet standards. Therefore, if the prosthetic valve leaflets are not universal, it will increase the design workload of the designer.

[0064] The combination of artificial valve leaflets and a membrane increases the compressibility of the self-expanding heart valve stent compared to the traditional method of using a whole artificial valve leaflet to cover the entire self-expanding heart valve stent. Because the thickness of the mesh woven with PET material used is thinner than the artificial valve leaflet, the internal space occupied by the self-expanding heart valve stent including the membrane is reduced, thereby increasing the compressibility of the self-expanding heart valve stent including the membrane.

[0065] The artificial valve leaflet may comprise one or more synthetic materials, engineered biological tissue, biological leaflet tissue, pericardial tissue, cross-linked pericardial tissue, aortic root tissue, chemically or biologically processed / treated tissue, 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.

[0066] In this embodiment, the distal end of the artificial valve leaflet 2 is no longer fixedly connected to the fastener 13 but is fixedly connected to the fastener 13 and the membrane 3 of the self-expanding heart valve stent including the membrane at the locking end. Since the membrane 3 can be penetrated arbitrarily using sutures, the artificial valve leaflet 2 can be firmly connected to the membrane 3, and the density of suturing can be increased, so that the sealing performance between the artificial valve leaflet 2 and the membrane 3 is better, preventing blood from leaking through the joint position of the artificial valve leaflet 2 and the membrane 3. Moreover, by suturing the membrane 3 and the artificial valve leaflet 2, the operator does not need to frequently bypass the fastener 13 or the fixing hole with the suture, thereby reducing the labor intensity of the operator and improving efficiency.

[0067] In a specific embodiment, if the artificial valve leaflets are directly sutured to the self-expanding heart valve stent, then as the stent changes, the artificial valve leaflets will inevitably move with the stent, and the movement of the stent is rigid relative to the membrane, that is, the movement state is fixed. Therefore, when the artificial valve leaflets and the stent are sutured, during the compression process of the self-expanding heart valve stent including the membrane, the stent will tear the artificial valve leaflets. However, when the artificial valve leaflets and the membrane are sutured, the membrane is relatively soft and allows a certain degree of displacement, so it will not produce excessive tearing force on the artificial valve leaflets, thereby ensuring the safety of the artificial valve leaflets.

[0068] In a specific embodiment, in order for the membrane 3 to be able to adapt to the self-expanding heart valve stent including the membrane, the PET woven fabric is designed to improve the fixing method of the artificial valve leaflet and the connecting frame.

[0069] PET woven fabric is usually woven from longitudinal threads (warp) and transverse threads (weft). Figure 4The angle between the longitudinal and transverse threads of the PET woven fabric is set to 60° to 90°. This angle is set because the angle (acute or obtuse angle supplementary angle) formed by any two directly connected connecting rods in the rhombus structure of the self-expanding heart valve stent's retaining end 16 and its reinforcing mesh 15 ranges from 60° to 90°. Therefore, the angle formed by the longitudinal and transverse threads of the PET woven fabric is consistent with the angle (acute or obtuse angle supplementary angle) formed by the connected connecting rods in the rhombus structure. It should be noted that when the angle formed by the connected connecting rods in the rhombus structure is 90°, the angle between the longitudinal and transverse threads of the PET woven fabric is also 90°. However, the angle formed by the connected connecting rods in the rhombus structure is generally not less than 60°. If the angle is too small, the supporting strength of the prismatic structure will be affected.

[0070] During suturing, it is necessary to ensure that the longitudinal line of the PET woven cloth is parallel to one of the connecting rods of the diamond structure and fixed on the bracket. Since the 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 to the connecting rod fixed with the PET woven cloth will be parallel to the transverse line of the PET woven cloth. At this time, the transverse line is fixed to the connecting rod. By analogy, each connecting rod of the diamond structure of the positioning end 16 and the reinforcing net 15 will be parallel to the longitudinal line or transverse line of the PET woven cloth and fixedly connected. At this time, when compressing the self-expanding heart valve stent including the coating, the PET woven cloth fixedly connected to the connecting rod of the diamond structure will move with the connecting rod, and at this time, the upper and lower connection points of the connecting rod of the diamond structure are also composed of several longitudinal lines and transverse lines, rather than being connected by a single longitudinal line (transverse line). As the horizontal and vertical lines of the woven PET fabric move with the rhombus-shaped connecting rods, the lines, originally tilted relative to the axis of the covered self-expanding heart valve stent, gradually become parallel to the stent axis. At this point, the axial distance between the ends of the horizontal and vertical lines (the distance along the axis of the covered self-expanding heart valve stent) gradually increases. The axial distance of the woven PET fabric increases as the covered self-expanding heart valve stent compresses, thereby preventing the regurgitant stent from compressing and deforming. In this context, the rhombus-shaped connecting rods may include the rods 152 of the reinforcement mesh structural unit 151 or the rods 162 of the retaining end structural unit 161, described below.

[0071] In a specific embodiment, Figure 8 and Figure 9As shown, the ear portion 403 of the artificial valve leaflet 3 passes through the connecting frame 143 and bypasses the side posts of the connecting frame 143, allowing the tail end of the ear to return to the interior of the self-expanding heart valve stent containing the membrane and fit the artificial valve leaflet at the connection between the main body of the artificial valve leaflet and the ear portion. A wavy suture line 5 is then passed through the artificial valve leaflet 3 located on the same connecting frame, tightly bonding the tail end of the artificial valve leaflet ear portion 403 to the artificial valve leaflet 3 and tightly fitting the connection between the main body 404 of the adjacent artificial valve leaflet and the ear portion 403 (hereinafter referred to as the ear connection), thereby achieving fixation of the artificial valve leaflet 2 and tight bonding of adjacent artificial valve leaflets near the stent. It should be noted that the wavy fold line refers to the suture line being sewn along the wavy path. Its main purpose is to increase the contact area between the tail end of the artificial valve leaflet ear and the artificial valve leaflet ear connection, thereby increasing stability. It also increases the contact area between the ear connections of adjacent artificial valve leaflets, preventing blood backflow near the stent side of the artificial valve leaflet.

[0072] In a specific embodiment, Figure 10 and 11 As shown, because the artificial valve leaflet 2 has a certain elasticity, if only wavy sutures are used to fix the artificial valve leaflet, the elastic action of the artificial valve leaflet will cause the artificial valve leaflet to slide relative to the side column of the connecting frame, thereby affecting the effect of the artificial valve leaflet. Therefore, it is necessary to increase the wrapping force of the artificial valve leaflet on the side column, so the surrounding suture 6 is added.

[0073] In the first embodiment, each adjacent circumferential suture is independent and encircles the connecting frame, ensuring that the ear of the prosthetic valve leaflet is tightly fitted to the side column. Adjacent circumferential sutures sequentially pass through the valleys on both sides of the wavy suture, effectively preventing the circumferential sutures from tearing the prosthetic valve leaflet on only one side of the wavy suture, which could affect the performance and service life of the prosthetic valve leaflet.

[0074] In the second embodiment, the surrounding suture is formed by a clockwise spirally wound surrounding suture and another counterclockwise spirally wound surrounding suture from top to bottom. Compared with the above-mentioned independent surrounding sutures, each spirally wound surrounding suture adopts an integrated spiral surrounding suture, which is simple to operate and firmly fixed. There are no excessive suture ends, which increases the stability of use. The "one" here does not refer to a single suture, but can also be a bundle of sutures, that is, several sutures. The two sutures pass through the valleys on both sides of the wavy suture in turn, preventing the connecting frame from generating asymmetric force due to suturing, thereby preventing the artificial valve leaflet from being torn, thereby affecting the performance and service life of the artificial valve leaflet.

[0075] In a specific embodiment, the ear 403 of the artificial valve leaflet 2 is tilted downward relative to the horizontal line on the artificial valve leaflet body 403. The main reason is: in order to further shorten the length of the stent, the position of the connecting frame is shorter than the distance between the distal end of the artificial valve leaflet and the proximal end of the artificial valve leaflet. Therefore, in order to adapt to the shorter stent, the ear of the artificial valve leaflet needs to be tilted downward so that it can be smoothly placed in the connecting frame. Moreover, the two downward-tilted artificial valve leaflet ears will be parallel to each other under the action of the connecting frame. Therefore, at this time, the horizontal line on the artificial valve leaflet body will have a bending tendency, which is conducive to the mutual closure of the middle parts of the proximal ends of adjacent artificial valve leaflets.

[0076] In a specific embodiment, Figure 3-6 As shown, the artificial valve leaflet 2 may include an artificial valve leaflet body 404, ears 403, and a concave area 402. In one embodiment, the artificial valve leaflet body 404 is configured to be generally V-shaped, but concave areas 402 are provided on both sides of the artificial valve leaflet body 404 near the distal end. The main purpose of the concave areas 402 is to accommodate the fastening arc convex portion 137 of the fastener 13. Not only does this reduce the material used for the artificial valve leaflet, but the concave areas 402 of the artificial valve leaflet 2 and the fastening arc convex portion 137 of the fastener 13 maintain the same arc direction. When the stent is compressed, that is, when the fastener 13 is straightened, the concave areas 402 of the artificial valve leaflet 2 will not generate a large reaction force on the fastening arc convex portion 137 of the fastener 13, thereby affecting the compression of the stent.

[0077] In a specific embodiment, reference Figure 7 The distal edge of the artificial leaflet body 404 is provided with an anti-wear edge strip 405, which is combined with the artificial leaflet body 404 by suturing, and is firmly fixed. The setting of the anti-wear edge strip 405 first increases the tear resistance of the distal end of the artificial leaflet body 404, and secondly reduces the damage to the artificial leaflet 2 caused by the friction between the distal end of the artificial leaflet body 404 and the membrane 3, thereby increasing the service life of the artificial leaflet 2. The setting of the anti-wear edge strip 405 is also equivalent to a buffer layer between the artificial leaflet 2 and the membrane 3, which effectively buffers the tearing force of the artificial leaflet 2 on the membrane 3 during the opening and closing process, thereby increasing the service life of the self-expanding heart valve stent including the membrane.

[0078] In this embodiment, the inner coating 3 of the locking end 16 is a leak-proof skirt.

[0079] In a specific embodiment, the distal end of the locking end 16 is provided with a leak-proof skirt (not shown in the figure), and the outer side of the locking end 16 is also coated, and the distal end of the outer coating extends to the proximal end of the fastener 13. The outer coating of the locking end 16 can be the inner coating turned outward to the outside, or it can be a single coating, which effectively prevents the reflux stent from causing side leakage and increases the anti-side leakage performance of the stent.

[0080] Next, we will combine Figure 12-1 7 describes in detail the structure and features of the self-expanding heart valve stent in this embodiment without the mesh-shaped braided covering.

[0081] First reference Figure 12 and Figure 13 The self-expanding heart valve stent 1 described in this 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 an extended state, and a proximal end of the self-expanding heart valve stent away from the apex of the heart when the self-expanding heart valve stent is in an extended state. The proximal end of the self-expanding heart valve stent may include a connector 14 and a positioning member 12 and a fastener 13 arranged between adjacent connectors. The fastener 13 can be used to fix the artificial heart valve leaflet together with the mesh-shaped braided covering 3. In a specific embodiment, with reference to Figure 12 and Figure 13 The distal end of the self-expanding heart valve stent further includes a locking end 16 and a reinforcing mesh 15, and a hollow structure 17 is present between the locking end 16 and the reinforcing mesh 15. The locking end 16 may include a diamond-shaped structure.

[0082] In a specific embodiment, reference Figure 12 and Figure 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 the first connecting member, and the second positioning arm 122 is fixedly connected to the second connecting member. The first connecting member is adjacent to the second connecting member. The fastener 13 includes a first fastening arch 131, a second fastening arch 132, and a fastener distal end 133 connecting the first fastening arch 131 and the second fastening arch 132. The first fastening arch 131 is fixedly connected to the first connecting member, and the second fastening arch 132 is fixedly connected to the second connecting member. The first connecting member is adjacent to the second connecting member.

[0083] In one embodiment of the first aspect, referring to Figure 16 and Figure 17BWhen the self-expanding heart valve stent 1 is in the extended state, the fastening arc of the fastener 13 includes a fastening arc concave portion 136 and a fastening arc convex portion 137. The fastening arc concave portion 136 is an arc-shaped rod-shaped structure that bulges away from the self-expanding heart valve stent, and the distal end of the fastening arc concave portion 136 is fixedly connected to the fastening arc convex portion 137. The fastening arc convex portion 137 is an arc-shaped rod-shaped structure that bulges toward the self-expanding heart valve stent. The distal end of the fastening arc convex portion 137 is connected to the adjacent fastening arc convex portion 137 through the fastener distal end 133. Through this design, the distal end of the fastener is opened smaller, preventing the artificial valve leaflet from opening and closing too much and invading the native valve leaflet area. Secondly, the fastener 13 may also be composed of two sections and / or three sections (such as adding a straight section between the fastening arc concave portion 136 and the fastening arc convex portion 137). For the fastener 13 composed of two sections, it is obvious that the opening angle of the fastener 13 distal end relative to the fastening arc convex portion 137 is smaller, so that the fastening arc convex portion 137 at the distal end of the fastener 13 changes less in angle during the process from compression to expansion. Although nickel-titanium alloy has superelasticity, excessive compression and expansion deformation still affects the performance of nickel-titanium alloy. Therefore, reducing the deformation degree of nickel-titanium alloy can make its self-expansion performance better, which is beneficial to the self-expansion of the self-expanding heart valve stent.

[0084] In a specific embodiment, reference Figure 13 When the heart valve stent is in a compressed state, the first positioning arm 121 and the second positioning arm 122 are linear. The first positioning arm 121 and the second positioning arm 122 are designed to be linear in order to facilitate compression. When fully compressed, the space they occupy is minimal, and the linear structure can ensure that the two will not interfere with each other during compression. In addition, the stent is cut from a nickel-titanium tube, but it should be noted here that the material used can be any material that can be implanted in the human body. The linear design is also conducive to processing, shortening the processing path and reducing processing costs.

[0085] In a specific embodiment, the distal end of the positioning member 12 is a parabolic structure, which reduces the contact stress between the positioning member 12 and the sinus floor and prevents the valve ring from rupturing.

[0086] In a specific embodiment, the width of the fastener 13 is wider than that of the support member 11 and the positioning member 12 to provide strong support.

[0087] In a specific embodiment, when the heart valve stent is in an extended state, the positioning member 12 has a second opening angle, 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 fastener 13 produce a certain opening angle, which makes it easier for the positioning member 12 to capture the leaflets and reduce the difficulty of the operation. The positioning member 12 can be used to prevent the valve from shifting in the ventricular direction, and to align the distal end of the artificial leaflet with the native leaflet, so as to restore the function of the native valve to the greatest extent, while keeping the artificial valve in the position of the original native valve. Therefore, the artificial valve replaces the native valve well, reduces the impact on blood flow, and reduces the occurrence of thrombosis. The second opening angle of 4°-14° enables the positioning member 12 and the fastener 13 to clamp the native valve, preventing the native valve from moving freely, while the native leaflet and the stent fit tightly, reducing paravalvular leakage.

[0088] In a specific embodiment, the vertical distance between the distal end of the positioning member 12 closest to the distal end of the heart valve stent and the farthest distal end of the heart valve stent (i.e., the locking end 16 described below) is 4mm-8mm, preferably 6mm.

[0089] In one embodiment, the distal end of the locking end 16 is flared relative to the proximal end of the locking end 16 , and the angle of flare of the distal end of the locking end 16 relative to the proximal end of the locking end 16 is 6°-14°. This flare is necessary to prevent the lightweight heart valve stent from moving toward the aorta and to provide an anchoring effect. Furthermore, an excessively large angle is necessary to prevent contact with the His bundle, which could affect normal heartbeat and endanger life.

[0090] In this embodiment, the number of rhombus-shaped squares at the retaining end 16 is 18, effectively increasing the compressibility of the heart valve stent. Furthermore, the width of the rods forming the rhombus-shaped squares is gradually changing (thin in the middle and wide at both ends) to optimize the stent's fatigue resistance. This also enhances the rebound effect of the retaining end 16, facilitating stent self-expansion. Furthermore, because the heart valve stent described herein includes only 18 rhombus-shaped squares, only one reinforcing mesh 15 is required between adjacent fastening arcs of the heart valve stent to connect the retaining end 16. This allows for the formation of numerous hollowed-out areas, effectively reducing the weight of the heart valve stent and facilitating compression. Furthermore, the width of the rods forming the rhombus-shaped squares is gradually changing (thin in the middle and wide at both ends) to optimize the stent's fatigue resistance. Furthermore, the presence of the reinforcing mesh 15 not only increases the structural strength of the stent's central portion, but also isolates the native valve leaflets to prevent them from invading the artificial valve leaflets.

[0091] Next, more technical features of the reinforcing mesh 15 are described in more detail.

[0092] In another embodiment, reference Figure 12-14 A reinforcing net 15 is provided between the locking end 16 and the fastener 13 , the distal end of the reinforcing net 15 is fixed to the locking end 16 , and the proximal end of the reinforcing net 15 is fixedly connected to different fastening arcs of adjacent fasteners 13 .

[0093] In a preferred embodiment, the reinforcing mesh 15 includes 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 are fixedly connected to the second fastening arch of the first fastener, and the reinforcing mesh structural units 151 on the other side of the proximal end of the reinforcing mesh 15 are fixedly connected to the first fastening arch of the second fastener. In other words, the proximal ends of the reinforcing mesh 15 are respectively connected to different fastening arches of different fasteners, thereby achieving a fixed connection.

[0094] In a preferred embodiment, along the axial direction from the proximal end of the heart valve stent to the distal end of the heart valve stent, the reinforcing mesh 15 includes three layers connected to each other in sequence, the first layer includes a reinforcing mesh structural unit 151, the second layer includes two reinforcing mesh structural units 151, and the third layer includes a reinforcing mesh structural unit 151. The reinforcing mesh structural unit 151 of the first layer shares an edge with the second fastening arc of the fastener on its left, and shares an edge with the first fastening arc of the fastener on its right. The reinforcing mesh structural unit 151 on the left side of the second layer shares an edge with the second fastening arc of the fastener 13 on its left, and the reinforcing mesh structural unit 151 on the right side of the second layer shares an edge with the first fastening arc 111 of the fastener 13 on its right. The reinforcing mesh structural unit 151 of the third layer shares a vertex with the locking end structural unit. In this embodiment, the reinforcing mesh structural unit connection area 154 of the second layer of the reinforcing mesh extends a predetermined length along the circumferential and longitudinal directions of the self-expanding heart valve stent respectively. In a specific embodiment, similar to the rods constituting the locking end structural unit 161 , the width of the rods 152 constituting the reinforcing net structural unit 151 is smaller in the middle and larger at both ends.

[0095] Next, more technical features of the latching end 16 are described in more detail.

[0096] In a specific embodiment, first refer to Figure 15 The self-expanding heart valve stent 1 may include a locking end 16, which includes a plurality of mutually connected locking end structural units 161, and the width of the rod 162 constituting the locking end structural unit 161 is smaller in the middle and larger at both ends. Figure 15In the embodiment shown, the rod 162 of the locking end structural unit 161 can be symmetrical, with the smallest width in the middle, and then smoothly increasing in the direction of the two ends without step-like mutations. Therefore, the edge of the rod 162 is smooth. The connecting rod of the locking end adopts a design that is thin in the middle and thick at both ends, which optimizes the fatigue resistance of the stent. However, if the middle position is too thin, it will affect the radial support force of the locking end. Therefore, it is necessary to optimize the fatigue resistance of the locking end of the stent while ensuring the radial support force of the locking end, so the minimum width X of the connecting rod at the locking end should be controlled within the range of 0.53 to 0.93 times the maximum width dimension Y.

[0097] In a specific embodiment, the latching end structural unit 161 is a diamond-shaped grid, and the latching end 16 may include 18 latching end structural units 161 arranged in a layer and connected to each other. Adjacent latching end structural units 161 can be connected to each other by sharing a common vertex. The connecting area 164 of adjacent latching end structural units extends a predetermined length along the circumference and longitudinal direction of the lightweight heart valve stent.

[0098] Next, the structure of the connecting member 14 of this embodiment will be described in more detail. Figure 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 to the connecting frame 143 through the connecting web 142. The connecting block 141 is for connecting to a conveyor for conveying the heart valve stent. Along the direction from the proximal end of the heart valve stent to the distal end of the heart valve stent, the connecting frame 143 may include a positioning member connecting part and a fastener connecting part in sequence. One end of the long strip suture hole 144 may be set at the positioning member connecting part, and the other end is set at the fastener connecting part.

[0099] In a specific embodiment, the width of the connecting web 142 is smaller than the width of the connecting block 141. In another embodiment, the connecting frame 143 includes a hollow elongated suture hole 144. One end of the elongated suture hole 144 can be set at the positioning piece connection part, and the other end is set at the fastener connection part. The elongated suture hole 144 can enable the proximal edge of the artificial valve leaflet 2 to be sutured directly through the suture hole without adding a suture gasket. The edge of the artificial valve leaflet 2 is sutured with the fastening arc. Compared with the traditional method of using a gasket and a stent to extrude and fix the valve leaflet, such a suturing method first reduces the external additional parts of the stent, and the absence of a gasket is also conducive to further compression of the stent. If there is a gasket, it not only affects the compression of the stent, but sometimes even damages the artificial valve leaflet 2 when the stent compression is small.

[0100] In another embodiment, the positioning member 12 may include a pull wire composite ring 124, which is fixedly connected to the positioning member 12 and located on the 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 to install a marker, and the second through-hole 1242 is suitable for inserting a pull wire. The second through-hole 1242 is located closer to the proximal end of the heart valve stent than the first through-hole 1241. In a specific embodiment, the diameter of the first through-hole 1241 is larger than that of the second through-hole 1242. The pull wire composite ring structure provided at the distal end of the positioning member 12 combines the installation of the pull wire and the marker (the marker is radiopaque) in a single location, effectively reducing the space occupied by the product. This single location allows for the opening and closing control and positioning of the positioning member, which not only improves the product's compressibility and facilitates catheter delivery, but also reduces the difficulty of surgical operation by allowing the positioning member to be opened. The pull wire composite ring structure has two through holes. The large hole is for placing marker points to facilitate accurate implantation and positioning, ensuring that the positioning piece touches the sinus floor, and the small hole is convenient for inserting the pull wire. However, it should be noted that the pull wire uses a small hole to ensure that the pull wire will not shake in the small hole and affect the accuracy of operating the positioning piece. Therefore, it is preferred that the diameter of the pull wire hole is smaller than the diameter of the large hole. However, it is not ruled out that the diameter of the pull wire hole is equal to or larger than the diameter of the large hole. During the implantation process, the positioning piece angle is controlled by the pull wire to facilitate the capture of the leaflet and reduce the difficulty of operation. In a preferred embodiment, the pull wire composite ring is arranged at the distal end of the positioning piece and is tilted inward relative to the axis of the stent 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. In severe cases, it may cause aortic dissection in the user and threaten the user's life. The positioning piece can thus be pulled toward the outside of the heart valve stent by the pull wire.

[0101] In the embodiment shown in the accompanying drawings, the heart valve stent may include three identical positioning members, fasteners, and connectors. Adjacent connectors are connected by positioning members and fasteners. At the same time, adjacent positioning members and fasteners are connected by connectors.

[0102] By eliminating the support member, the proximal end of the positioning member 12 is connected to the proximal end of the connecting frame 143, or the proximal end of the positioning member is connected to the distal end of the connecting web 142, and the connection between the positioning member 12 and the connecting web 142 forms the proximal end of the connecting frame 143. Because the support member is eliminated in the above structural design, the proximal end of the positioning member can be positioned closer to the proximal end of the regurgitant stent, thereby increasing the distance between the proximal and distal ends of the positioning member, that is, increasing the space for the positioning member 12 to clamp the native valve leaflets. Therefore, when facing larger native valve leaflets of the aorta (pulmonary) artery, the positioning member 12 will not be unable to be inserted into the sinus floor due to obstruction by the native valve leaflets. The distal end of the positioning member can be fully inserted into the sinus floor, preventing the distal end of the positioning member 12 from being unable to be inserted into the sinus floor, causing the regurgitant stent to shift under the large pressure differential generated during ventricular diastole of the heart, causing the distal end of the positioning member 12 to impact the sinus floor and cause damage to the sinus floor.

[0103] Example 2

[0104] The difference between Example 2 and Example 1 is that the proximal end of the self-expanding heart valve stent further includes a support member 11.

[0105] refer to Figure 18-21 The proximal end of the self-expanding heart valve stent of this embodiment further includes a support member 11, which is disposed between adjacent connectors 14. The support member 11 may include a first support arm 111, a second support arm 112, and a support member distal end 113 connecting the first support arm 111 and the second support arm 112. The first support arm 111 is fixedly connected to the first connector, the second support arm 112 is fixedly connected to the second connector, and the first connector is adjacent to the second connector.

[0106] 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 member 11 and the positioning member 12 form rods that protrude toward the distal end of the self-expanding heart valve stent. In this embodiment, the support member 11 can be positioned on one side of the native heart valve leaflets, and the positioning member 12 on the other side, to clamp the native leaflets. The support member 11 and the positioning member 12 can work together to clamp the native heart valve leaflets, preventing interference with the prosthetic heart valve leaflets.

[0107] Unlike Example 1, the connecting frame 143 of this embodiment further includes a support member connecting portion, which is closer to the connecting block 141 than the positioning member connecting portion. In a specific embodiment, the support member connecting portion may be symmetrical, with one side connected to the first support arm of the first support member and the other side connected to the second support arm of the adjacent second support member. In a preferred embodiment, the upper edge of the connection between the support arm and the connecting frame 143 is a smooth arc, and the angle of the arc is 100°-160°. At the same time, the lower edge of the connection between the support arm and the connecting frame 143 is also a smooth arc, and the angle of the arc is an acute angle.

[0108] In a specific embodiment, the support arm of the support member includes an X point, and the first support arm or the second support arm is bent at the X point, and the deformation point is away from the connecting frame, reducing the force concentration. Because the support member and the positioning member are both connected to the connecting frame 143, and the space of the connecting frame 143 is limited, if the support member connection part and the positioning member connection part in the connecting frame are very close. If the deformation position of the support member relative to the connecting frame and the deformation position of the positioning member relative to the connecting frame are both at the connection point, and the support member and the positioning member are respectively located on both sides of the valve, if the deformation position of the two relative to the connecting frame is too close, it is easy to generate a large shear force on the native valve close to the connecting frame, thereby damaging the valve, and if the deformation area is too close, stress concentration is also easy to occur, causing the connection between the support member / positioning member and the connecting frame to break. At this time, it is necessary to increase the distance between the two relative to the deformation position of the connecting frame, so by increasing the cross-sectional area of ​​the support member and the connecting frame while maintaining the streamlined shape of the support member and the connecting frame, it is convenient for the conveyor to release the modified stent. The upper edge of the connection between the support arm and the connecting frame is a smooth arc, and the angle of the arc is 100°-160°, and the lower edge of the connection between the support arm and the connecting frame is also a smooth arc, and the angle of the arc is an acute angle in order to form a stress concentration release arc with the connection between the lower positioning member and the connecting frame, to prevent the formation of a stress concentration point, causing the connection between the support member / positioning member and the connecting frame to break. In the heart valve stent described in this article, the deformation position of the support member relative to the connecting frame is transferred to point X away from the connecting frame, which solves the problem of easily generating a large shear force on the native valve close to the connecting frame, and the position of the two deformation zones becomes farther away, which also prevents the problem of excessive stress concentration.

[0109] In a specific embodiment, the width of the connecting web 142 is smaller than the width of the connecting block 141, and smaller than the width of the support member connecting portion. In another embodiment, the connecting frame 143 includes a hollow elongated suture hole 144. One end of the elongated suture hole 144 can be set at the support member connecting portion, and the other end is set at the positioning member connecting portion or the fastener connecting portion. The elongated suture hole 144 can achieve the proximal edge of the artificial heart valve leaflet to be sutured directly through the suture hole without adding a suture gasket. The edge of the artificial heart valve leaflet is sutured with the fastening arc. Compared with the traditional method of using a gasket and a heart valve stent to squeeze and fix the leaflet, this suturing method first reduces the external additional parts of the stent, and the absence of a gasket is also conducive to further compression of the heart valve stent. If there is a gasket, it not only affects the compression of the stent, but sometimes even damages the artificial heart valve leaflet when the stent compression is small.

[0110] refer to Figure 21 In a specific embodiment, the locking end structural unit 161 is a diamond-shaped grid, and the locking end 16 may include a plurality of locking end structural units 161 arranged in a layer and connected to each other. Adjacent locking end structural units 161 can be connected to each other by sharing a vertex. The adjacent locking end structural unit connection areas 164 respectively extend predetermined lengths along the circumferential and longitudinal directions of the self-expanding heart valve stent. Along the circumferential direction of the self-expanding heart valve stent, the adjacent locking end structural unit connection areas 164 include a curved structure 163 that is recessed toward it. Because the width of the two ends of the rod 162 is the widest, the rod 162 is widest and most difficult to deform at the position near the locking end structural unit connection area 164, so a large stress will be generated during the compression and expansion process, which can easily cause the rod 162 to break at the position near the locking end structural unit connection area 164. By adding the curved structure 163, the bending stress of the rod 62 near the connection area 164 of the locking end structural unit is reduced, and the rod 162 can be prevented from breaking during the compression and self-expansion process of the locking end of the self-expanding heart valve stent. At the same time, the curved structure 163 enables the suture thread to be fixed at the curved structure 163 when the stent is sutured to the membrane, preventing the suture thread from sliding on the locking end structural unit and affecting the fixation of the membrane.

[0111] The features of other structures not specifically described in this embodiment, such as the covering 3, artificial valve leaflet 2, positioning member 12, fastener 13, reinforcing mesh 15, etc., are the same as those in Example 1. Please refer to the description in Example 1.

[0112] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above and that the invention can be embodied in other specific forms without departing from the spirit or essential characteristics of the invention. Therefore, the embodiments should be considered in all respects as illustrative and non-restrictive, and the scope of the invention is defined by the appended claims, not the foregoing description, and all variations within the meaning and range of equivalents of the claims are intended to be included therein. Any reference sign in a claim should not be construed as limiting the claim to which it relates.

Claims

1. A self-expanding heart valve stent comprising a membrane, comprising a distal end of the self-expanding heart valve stent proximal to the apex of the heart when the self-expanding heart valve stent is in an expanded state and a proximal end of the self-expanding heart valve stent distal to the apex of the heart when the self-expanding heart valve stent is in an expanded state, characterized in that: The self-expanding heart valve stent including the membrane comprises a flexible mesh-shaped braided membrane, and the flexible mesh-shaped braided membrane is fixed to the inner side of the distal end of the self-expanding heart valve stent including the membrane for fixing the artificial valve leaflet; The proximal end of the self-expanding heart valve stent includes a connector and a fastener disposed between adjacent connectors, the fastener being used to fix the artificial heart valve leaflet together with the grid-shaped braided covering, the fastener including a first fastening arch, a second fastening arch, and a fastener distal end connecting the first fastening arch and the second fastening arch, the first fastening arch being fixedly connected to the first connector, the second fastening arch being fixedly connected to the second connector, and the first connector being adjacent to the second connector; The grid-like woven membrane is woven from longitudinal and transverse lines, and the angle between the longitudinal and transverse lines is set to 60° to 90°; The distal end of the self-expanding heart valve stent including the membrane includes a locking end, which includes interconnected diamond structures. The longitudinal lines of the grid-like braided membrane are fixed to the self-expanding heart valve stent in parallel with one of the connecting rods of the diamond structure.

2. The self-expanding heart valve stent with a membrane according to claim 1, wherein: When the self-expanding heart valve stent is in an extended state, the first fastening arch and the second fastening arch of the fastener include: A fastening arc recessed portion, wherein the fastening arc recessed portion is an arc-shaped rod-shaped structure that protrudes in a direction away from the self-expanding heart valve stent and simultaneously protrudes toward the proximal end of the self-expanding heart valve stent; A fastening arc convex portion, wherein the fastening arc convex portion is an arc-shaped rod-shaped structure that convexes toward the self-expanding heart valve stent and simultaneously convexes toward the distal end of the self-expanding heart valve stent; The proximal end of the fastening arc recessed portion is connected to the connector, the distal end of the fastening arc recessed portion is fixedly connected to the fastening arc convex portion, and the distal end of the fastening arc convex portion is connected to the adjacent fastening arc convex portion through the distal end of the fastener.

3. The self-expanding heart valve stent with a membrane according to claim 1, wherein: The mesh-like braided membrane is fixed to the self-expanding heart valve stent including the membrane by suturing the components of the self-expanding heart valve stent including the membrane.

4. The self-expanding heart valve stent with a membrane according to claim 1, wherein: The distal end of the locking end is provided with an outer covering film of the locking end used as a leak-proof skirt, and the distal end of the outer covering film of the locking end extends all the way to the proximal end of the fastener.

5. The self-expanding heart valve stent with a membrane according to claim 4, wherein: The outer covering film of the locking end is the inner covering film turned outward to the outside, or is a single covering film.

6. The self-expanding heart valve stent comprising a membrane according to any one of claims 1 to 5, wherein: Also included is an artificial valve leaflet, the artificial valve leaflet comprising an artificial valve leaflet body and an ear portion, the outer contour of the artificial valve leaflet body comprising an inner concave area concave toward the artificial valve leaflet; The connecting member includes a connecting block, a connecting web, and a connecting frame. One end of the connecting block forms the proximal end of the self-expanding heart valve stent containing the membrane, and the other end is connected to the connecting frame through the connecting web. Along the direction from the proximal end of the self-expanding heart valve stent containing the membrane to the distal end of the self-expanding heart valve stent containing the membrane, the connecting frame sequentially includes a positioning member connecting portion and a fastener connecting portion. The proximal end of the artificial valve leaflet is fixed to the connector of the self-expanding heart valve stent containing the covering, and the distal end of the artificial valve leaflet is fixedly connected to the mesh-like braided covering across the fastening arc of the fastener.

7. The self-expanding heart valve stent comprising a membrane according to claim 6, wherein: The proximal end of the artificial valve leaflet is fixed to the connector of the self-expanding heart valve stent including the membrane by means of a wavy suture or a suture wrapped around the suture.

8. The self-expanding heart valve stent comprising a membrane according to claim 7, wherein: The proximal end of the artificial valve leaflet is fixed to the connector of the self-expanding heart valve stent containing the membrane by means of a surrounding suture, each adjacent surrounding suture is independent, and the surrounding suture surrounds the connecting frame so that the ear of the artificial valve leaflet fits tightly against the side column of the connecting frame.

9. The self-expanding heart valve stent with a membrane according to claim 7, wherein: The proximal end of the artificial valve leaflet is fixed to the connector of the self-expanding heart valve stent containing the membrane by means of a surrounding suture, wherein the surrounding suture is formed from top to bottom by a clockwise spirally wound surrounding suture and another counterclockwise spirally wound surrounding suture, and each spirally wound surrounding suture adopts an integrated spiral surrounding suture.

10. The self-expanding heart valve stent with a membrane according to claim 7, wherein: The proximal end of the artificial valve leaflet is fixed to the connector of the self-expanding heart valve stent containing the membrane by means of a wavy suture line. The ear of the artificial valve leaflet passes through the connecting frame and bypasses the side column of the connecting frame so that the tail end of the ear returns to the interior of the self-expanding heart valve stent containing the membrane and fits with the artificial valve leaflet at the connection between the artificial valve leaflet body and the ear. The wavy suture line passes through the artificial valve leaflet located on the same connecting frame, tightly combining the tail end of the ear of the artificial valve leaflet with the artificial valve leaflet, and tightly fitting the connection between the body and ear of the adjacent artificial valve leaflet, thereby achieving the fixation of the artificial valve leaflet and the tight combination of the adjacent artificial valve leaflets close to the stent side.

11. The self-expanding heart valve stent with a membrane according to claim 6, wherein: The artificial valve leaflet further comprises an anti-wear edge strip, which is arranged on the outer contour of the artificial valve leaflet body.

12. The self-expanding heart valve stent with a membrane according to claim 6, wherein: The ears of the artificial valve leaflet are inclined downward relative to the upper horizontal line of the artificial valve leaflet body.

13. The self-expanding heart valve stent with a membrane according to claim 6, wherein: The grid-shaped woven membrane is woven from PET material, and its thickness is less than that of the artificial valve leaflet.

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