A highly elastic anti-reflux cardiac valve stent

Abstract

The present application relates to a highly elastic anti-reflux cardiac valve stent. The distal end of the highly elastic anti-reflux cardiac valve stent includes a positioning member disposed between adjacent connecting members. The proximal end of the highly elastic anti-reflux cardiac valve stent includes a clamping end, and the clamping end includes at least one layer of interconnected diamond grid units. The highly elastic anti-reflux cardiac valve stent further includes a reinforcing mesh, and the reinforcing mesh includes at least one quadrilateral grid unit that forms an oval or diamond shape when the highly elastic anti-reflux cardiac valve stent is stretched. One end of the reinforcing mesh is fixedly connected to the connecting member, and the other end is fixedly connected to the distal end of the diamond grid unit. The positioning member of the highly elastic anti-reflux cardiac valve stent is connected to the clamping end through the elastic reinforcing mesh. When the valve is subjected to the reverse flow pressure of the aortic blood flow, the reinforcing mesh undergoes a certain deformation, buffering the impact of the positioning member on the bottom of the aortic sinus, reducing the damage of the positioning member to the bottom of the aortic sinus, and being more user-friendly.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a highly elastic anti-reflux heart valve stent. Background Art

[0002] Due to the many advantages of transcatheter surgery, such as minimal invasiveness and rapid recovery, more and more surgeries are beginning to use the transcatheter approach. The aortic valve replacement has also changed from the early surgical incision method to the transcatheter replacement of the aortic valve, and the heart valve stent is one of the key instruments for the success of transcatheter aortic valve replacement.

[0003] The heart valve stent usually includes the proximal end of the heart valve stent and the distal end of the heart valve stent. In a Chinese patent: Stent for positioning and anchoring the implantation site of a valve prosthesis in a patient's heart (Publication No.: CN102413793B), an aortic valve stent is disclosed. In order to better clamp the native leaflets, a wide fastening portion is used to connect between the proximal end and the distal end of the heart valve stent. However, such a design brings a great risk. That is, every time the left ventricle is in diastole, the valve stent will be subjected to the pressure of blood flow reflux from the aorta. At this time, the blood flow will drive the positioning member of the stent to rigidly impact the bottom of the aortic sinus, which is likely to cause damage to the sinus bottom.

[0004] Therefore, there is a continuous need in this field to develop a highly elastic anti-reflux heart valve stent. Summary of the Invention

[0005] The purpose of this application is to provide a highly elastic anti-reflux heart valve stent. Through research, it is found that the anti-reflux heart valve stent does not require a large clamping force on the native leaflets, but rather requires the positioning member to be inserted into the non-closed surface of the native leaflet, that is, the inside of the aortic sinus. All traditional stents have been designed to have a large supporting force to maintain the shape of the stent, that is, the whole stent has a certain strength, that is, the positioning member is relatively rigidly connected to the proximal end of the stent. Such a design brings a significant problem that when the stent bears the reflux pressure of the aortic blood flow each time, the positioning member will rigidly impact the bottom of the aortic sinus. Generally, the number of heartbeats of a person in a year is about 36 million times. Therefore, the continuous rigid impact of the positioning member on the bottom of the aortic sinus will cause inestimable damage to the bottom of the aortic sinus, and even pierce the bottom of the aortic sinus. Specifically, in the highly elastic anti-reflux heart valve stent described in this article, an elastic diamond grid is used to replace the fastening portion and the reinforcing mesh inside the fastening portion in the common heart valve stent, so that the positioning member is elastic relative to the proximal end of the stent.

[0006] To solve the above technical problems, this application provides the following technical solutions.

[0007] In a first aspect, the present application provides a highly elastic anti-reflux cardiac valve stent. The highly elastic anti-reflux cardiac valve stent includes a proximal end of the highly elastic anti-reflux cardiac valve stent and a distal end of the highly elastic anti-reflux cardiac valve stent. It is characterized in that the distal end of the highly elastic anti-reflux cardiac valve stent includes a positioning member disposed between adjacent connecting members. The positioning member is used to position the highly elastic anti-reflux cardiac valve stent. The positioning member includes a first positioning arm, a second positioning arm, and a distal end of the positioning member that connects the first positioning arm and the second positioning arm and protrudes toward the proximal end of the highly elastic anti-reflux cardiac valve stent;

[0008] The proximal end of the highly elastic anti-reflux cardiac valve stent includes a clamping end, and the clamping end includes at least one layer of interconnected diamond grid units;

[0009] The highly elastic anti-reflux cardiac valve stent further includes a reinforcing mesh. The reinforcing mesh includes at least one quadrilateral grid unit that is elliptical or diamond-shaped when the highly elastic anti-reflux cardiac valve stent is extended. One end of the reinforcing mesh is fixedly connected to the connecting member of the highly elastic anti-reflux cardiac valve stent, and the other end is fixedly connected to the distal end of the diamond grid unit;

[0010] The reinforcing mesh and the positioning member clamp the native leaflets together.

[0011] In an embodiment of the first aspect, the reinforcing mesh includes a first quadrilateral grid unit, which is formed by connecting a first connecting rod, a second connecting rod, a third connecting rod, and a fourth connecting rod. The proximal end of the first connecting rod is fixedly connected to the distal end of the second connecting rod, and the proximal end of the fourth connecting rod is fixedly connected to the distal end of the third connecting rod;

[0012] Wherein the distal ends of the first connecting rod and the fourth connecting rod are fixedly connected to the connecting member, and the proximal ends of the second connecting rod and the third connecting rod are fixedly connected to the distal end of the diamond grid unit.

[0013] In an embodiment of the first aspect, the reinforcing mesh includes a first quadrilateral grid unit and a second quadrilateral grid unit. The first quadrilateral grid unit is formed by connecting a first connecting rod, a second connecting rod, a third connecting rod, and a fourth connecting rod. The proximal end of the first connecting rod is fixedly connected to the distal end of the second connecting rod, and the proximal end of the fourth connecting rod is fixedly connected to the distal end of the third connecting rod. The second quadrilateral grid unit is formed by connecting a fifth connecting rod, a sixth connecting rod, a seventh connecting rod, and an eighth connecting rod. The proximal end of the fifth connecting rod is fixedly connected to the distal end of the sixth connecting rod, and the proximal end of the eighth connecting rod is fixedly connected to the distal end of the seventh connecting rod;

[0014] The distal ends of the first link and the fourth link are fixedly connected to the connecting member, the proximal ends of the sixth link and the seventh link are fixedly connected to the distal ends of the rhombic grid unit, and the second link, the third link, the fifth link, and the eighth link share a vertex.

[0015] In an embodiment of the first aspect, the reinforcing mesh further includes two third quadrilateral grid units, which are symmetrically arranged on both sides of the second quadrilateral grid unit. One side of the third quadrilateral grid unit close to the second quadrilateral grid unit shares a vertex with the second quadrilateral grid unit. The proximal end of the third quadrilateral grid unit is fixedly connected to the distal end of the rhombic grid unit, and the distal end of the third quadrilateral grid unit is a free end.

[0016] In an embodiment of the first aspect, when the quadrilateral grid units are two layers, the number of quadrilateral grid units increases in the direction from the distal end to the proximal end of the highly elastic anti-reflux heart valve stent.

[0017] In an embodiment of the first aspect, the reinforcing mesh is provided with multiple layers of quadrilateral grid units, and at least one layer of quadrilateral grid units is one.

[0018] In an embodiment of the first aspect, the reinforcing mesh has at least three layers of quadrilateral grid units. From the distal end to the proximal end of the reinforcing mesh, the number of quadrilateral grid units in each layer does not all increase, but some remain equal.

[0019] In an embodiment of the first aspect, the quadrilateral grid unit is composed of a reinforcing mesh link, and the middle of the reinforcing mesh link is thin and the two ends are wide. The rhombic grid unit is composed of a clamping end link, and the middle of the clamping end link is thin and the two ends are wide.

[0020] In an embodiment of the first aspect, the first positioning arm and the second positioning arm are linear or curved.

[0021] In an embodiment of the first aspect, when the highly elastic anti-reflux heart valve stent is extended, the opening angle of the positioning member is 2° - 14°.

[0022] In an embodiment of the first aspect, the distal end of the positioning member presents a parabolic shape.

[0023] In an embodiment of the first aspect, the vertical distance from the distal end of the positioning member to the distal end of the clamping end is 2 mm - 8 mm.

[0024] In an embodiment of the first aspect, the distal end of the clamping position end expands outward relative to the proximal end of the clamping position end, and the angle of the distal end of the clamping position end expanding outward relative to the proximal end of the clamping position end is 6°-14°.

[0025] In an embodiment of the first aspect, 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 anti-reflux heart valve stent, and the other end is connected to the connecting frame through the connecting web. The distal end of the connecting frame is fixedly connected to the distal ends of the first positioning arm and the second positioning arm, and the proximal end of the connecting frame is fixedly connected to the distal end of the quadrilateral mesh unit.

[0026] In an embodiment of the first aspect, the connecting frame includes a long strip-shaped suture hole adapted for the artificial valve leaf to pass through. One end of the long strip-shaped suture hole is close to the distal end of the connecting frame, and the other end is close to the proximal end of the connecting frame.

[0027] In an embodiment of the first aspect, the distal end of the high-elastic anti-reflux heart valve stent further includes a support member disposed between adjacent connecting members. The support member is closer to the distal end of the high-elastic anti-reflux heart valve stent than the positioning member and is used for fixing the native valve leaf;

[0028] The support member includes a first support arm, a second support arm and a distal end of the support member that connects the first support arm and the second support arm and protrudes toward the proximal end of the high-elastic anti-reflux heart valve stent.

[0029] In an embodiment of the first aspect, 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 anti-reflux heart valve stent, and the other end is connected to the connecting frame through the connecting web. The distal end of the connecting frame is fixedly connected to the distal ends of the first support arm and the second support arm, and the proximal end of the connecting frame is fixedly connected to the distal ends of the first positioning arm, the second positioning arm and the quadrilateral mesh unit.

[0030] Compared with the prior art, the positive effects of the present invention are as follows:

[0031] 1. The positioning member of the high-elastic anti-reflux heart valve stent described herein is connected to the clamping position end through an elastic reinforcing mesh. When the valve is subjected to the reverse flow pressure of the aortic blood flow, the reinforcing mesh generates a certain deformation, buffering the impact of the positioning member on the bottom of the aortic sinus, reducing the damage of the positioning member to the bottom of the aortic sinus, and being more user-friendly;

[0032] 2. The setting of the wire composite ring makes the high-elastic anti-reflux heart valve stent easier to position and manipulate.

[0033] In addition, the highly elastic anti-reflux cardiac valve stent described in this article has the following advantages. The positioning member forms a certain included angle with the stent, which facilitates the positioning member to capture the valve leaflets and reduces the surgical difficulty. The natural opening angle range of the positioning member in the deployed state is between 2° and 14°. In the embodiment with a support member, the opening angle of the support member is smaller than that of the positioning member. The bottom of the positioning member is parabolic, which reduces the contact stress with the sinus bottom and prevents the valve annulus from rupturing. The vertical distance from the distal end of the positioning member to the distal end of the clamping end is 2 mm - 8 mm, and the preferred size is 6 mm;

[0034] The distal end of the clamping end expands outward relative to the proximal end of the clamping end, and the angle of outward expansion of the distal end of the clamping end relative to the proximal end of the clamping end is 6° - 14°. The reason for the need for outward expansion is to prevent the anti-reflux stent from displacing towards the aorta. The clamping end plays an anchoring role with the aortic valve annulus. The reason for not being able to generate too large an angle is to prevent the clamping end extending into the heart from touching the His bundle, thereby affecting the normal beating of the heart and endangering life;

[0035] The support member is connected to the distal end of the connecting frame of the connecting member, while the positioning member is connected to the proximal end of the connecting frame of the connecting member. This design is to prevent the distal end of the support member and the distal end of the positioning member from forming a scissor structure, thereby shearing the native valve leaflets and causing secondary damage to the native valve leaflets of the human body;

[0036] The connecting rods of the quadrilateral mesh unit and the rhombus mesh unit still adopt the form of being thinner in the middle and wider at both ends, which increases the anti-fatigue performance of the highly elastic anti-reflux cardiac valve stent and improves the resilience performance of the highly elastic anti-reflux cardiac valve stent, facilitating the self-expansion of the highly elastic anti-reflux cardiac valve stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 Showing a highly elastic anti-reflux cardiac valve stent according to one embodiment.

[0038] Figure 2 Showing Figure 1 The deployment view of the shown highly elastic anti-reflux cardiac valve stent.

[0039] Figure 3 Showing a highly elastic anti-reflux cardiac valve stent according to another embodiment.

[0040] Figure 4 Showing Figure 3 The deployment view of the shown highly elastic anti-reflux cardiac valve stent.

[0041] Figure 5 Showing a highly elastic anti-reflux cardiac valve stent according to another embodiment.

[0042] Figure 6 Showing Figure 5Expanded view of the highly elastic anti-reflux heart valve stent shown

[0043] Figure 7 Shows a highly elastic anti-reflux heart valve stent according to another embodiment

[0044] Figure 8 Shows Figure 7 Expanded view of the highly elastic anti-reflux heart valve stent shown

[0045] Figure 9 Shows a highly elastic anti-reflux heart valve stent according to another embodiment

[0046] Figure 10 Shows according to Figure 9 The highly elastic anti-reflux heart valve stent shown

[0047] Figure 11 Shows according to Figure 9 Expanded view of the highly elastic anti-reflux heart valve stent shown

[0048] Figure 12 Shows Figure 11 Partial enlarged view of region A in

[0049] Figure 13 Shows Figure 11 Partial enlarged view of region B in

[0050] Figure 14 Shows a highly elastic anti-reflux heart valve stent according to another embodiment

[0051] Figure 15 Shows Figure 14 Expanded view of the highly elastic anti-reflux heart valve stent shown

[0052] Figure 16 Shows the expanded view of a highly elastic anti-reflux heart valve stent according to another embodiment Specific embodiments

[0053] Unless otherwise defined, the technical terms or scientific terms used in this specification and claims shall have the ordinary meanings as understood by those of ordinary skill in the technical field to which the present invention pertains

[0054] In the description of the present invention, it should be understood that the orientation or positional relationship indicated by the terms "center", "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings. These 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 operated in a specific orientation. Therefore, it should not be construed as a limitation to the present invention.

[0055] In addition, the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, features defined 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, the meaning of "a plurality" is two or more.

[0056] In the description of the present invention, it should be noted that unless otherwise clearly specified and limited, the terms "mounted", "connected", and "coupled" should be understood in a broad sense. For example, they can be connected, detachably connected, or integrally connected; they can be mechanically connected or electrically connected; they can be directly connected or indirectly connected through an intermediate medium, and can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood through specific circumstances.

[0057] As described herein, when describing the heart valve stent, "proximal" refers to the side of the heart valve stent in the deployed state that is on the side of the delivery device or in the direction of the end manipulated by the user. Correspondingly, "distal" refers to the side of the heart valve stent in the deployed state that is away from the delivery device or away from the direction of the end manipulated by the user. In the present application, when describing the heart valve stent, "proximal end" refers to the side of the heart valve stent in the deployed state that is close to the apex of the heart. Correspondingly, "distal end" refers to the side of the heart valve stent in the deployed state that is away from the apex of the heart. Since the heart valve stent described herein is delivered through the aorta by catheter, the distal end and the proximal end refer to the same position, and the proximal and distal ends refer to the same position. However, this does not exclude the implantation method through the apex of the heart. Only the description of the heart valve stent delivered through the aorta by catheter is taken as an example herein.

[0058] Next, the technical solutions of the present application will be clearly and completely described in conjunction with the drawings and the embodiments of the present application.

[0059] Embodiment 1

[0060] This embodiment provides a highly elastic anti-reflux cardiac valve stent. The reinforcement mesh 13 of the highly elastic anti-reflux cardiac valve stent includes a quadrilateral mesh unit 131.

[0061] Referring to Figure 1 , the highly elastic anti-reflux cardiac valve stent of this embodiment may include a proximal end of the highly elastic anti-reflux cardiac valve stent and a distal end of the highly elastic anti-reflux cardiac valve stent. The distal end of the highly elastic anti-reflux cardiac valve stent includes a positioning member 12 disposed between adjacent connecting members 14. The positioning member 12 can be used to position the highly elastic anti-reflux cardiac valve stent. Referring to Figure 2 , the positioning member 12 may include a first positioning arm 121, a second positioning arm 122, and a distal end 123 of the positioning member that connects the first positioning arm 121 and the second positioning arm 122 and protrudes toward the proximal end of the highly elastic anti-reflux cardiac valve stent. In this embodiment, the proximal end of the highly elastic anti-reflux cardiac valve stent includes a clamping end 16, and the clamping end 16 includes 18 diamond-shaped mesh units 161 that are interconnected.

[0062] In this embodiment, the highly elastic anti-reflux cardiac valve stent further includes a reinforcement mesh 13. The reinforcement mesh 13 includes a quadrilateral mesh unit 131 that is oval or diamond-shaped when the highly elastic anti-reflux cardiac valve stent is extended. One end of the reinforcement mesh 13 is fixedly connected to the connecting member 14 of the highly elastic anti-reflux cardiac valve stent, and the other end is fixedly connected to the distal end of the diamond-shaped mesh unit 161. The quadrilateral mesh unit 131 is elastic in the axial direction.

[0063] Next, more details and features of the positioning member 12 of the highly elastic anti-reflux cardiac valve stent of this embodiment will be described first.

[0064] In this embodiment, the positioning member 12 can be used to position the highly elastic anti-reflux cardiac valve stent. The positioning member 12 may include a first positioning arm 121, a second positioning arm 122, and a distal end 123 of the positioning member that connects the first positioning arm 121 and the second positioning arm 122. The distal end 123 of the positioning member may protrude toward the proximal end of the highly elastic anti-reflux cardiac valve stent. 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 and the second connecting member are adjacent. After the highly elastic anti-reflux cardiac valve stent is placed in the aortic valve position, the positioning member 12 and the reinforcement mesh 13 clamp the native leaflets, and the artificial heart leaflets inside the highly elastic anti-reflux cardiac valve stent will replace the native leaflets to work.

[0065] In a specific embodiment, referring to Figure 2, when the heart valve stent is in a compressed state, the first positioning arm 121 and the second positioning arm 122 are linear. Designing the first positioning arm 121 and the second positioning arm 122 to be linear is to facilitate the compression of the highly elastic anti-reflux heart valve stent. When the highly elastic anti-reflux heart valve stent is fully compressed, the space it occupies is minimized, and the linear structure can ensure that the two do not interfere during compression. In addition, the highly elastic anti-reflux heart valve stent in this embodiment can be cut from a single nitinol tube. However, it should be noted here that the material used can be any material that can be implanted into the human body. The linear design is also beneficial for processing, shortening the processing path and reducing the processing cost.

[0066] In a specific embodiment, the distal end of the positioning member 12 can be a parabolic structure, which reduces the contact stress between the positioning member 12 and the sinus floor and prevents the rupture of the valve annulus. In a specific embodiment, when the highly elastic anti-reflux heart valve stent is in an extended state, the positioning member 12 has a second opening angle, and the second opening angle is 2° - 14°. For example, the second opening angle can be 4°, 6°, 8°, 10°, 12°, etc. The positioning member 12 can be used to prevent the valve from shifting towards the ventricle when subjected to the reverse flow pressure of the aortic blood flow, and to ensure that the distal end of the artificial valve leaflet is always aligned with the distal end of the native valve leaflet, so as to restore the function of the native valve to the greatest extent. At the same time, the artificial valve can be maintained at the position of the original native valve. Therefore, the artificial valve can well replace the native valve, reduce the impact on blood flow, and reduce the occurrence of thrombosis. The setting of the second opening angle of 2° - 14° can enable the positioning member 12 and the reinforcement mesh 13 to relatively clamp the native valve and prevent the native valve from moving freely. If the opening angle is not set, the positioning member 12 will press the native valve leaflet into the stent, causing the native valve leaflet to interfere with the artificial valve leaflet and affecting the operation of the valve. If the second opening angle is set too large, the clamping force between the positioning member 12 and the reinforcement mesh 13 will become weak, resulting in the native valve leaflet being unable to contact the positioning member 12 and the reinforcement mesh 13 simultaneously, and the native valve leaflet not being able to fit tightly with the stent, increasing the risk of paravalvular leakage of the valve.

[0067] In a specific embodiment, the vertical distance between the point on the distal end of the positioning member 12 closest to the distal end of the heart valve stent and the farthest point on the distal end of the heart valve stent (i.e., the clamping end 16 described below) is 2 mm - 8 mm, and the preferred size is 6 mm.

[0068] In this embodiment, the highly elastic anti-reflux cardiac valve stent may further include a wire composite ring 124. Specifically, the positioning member 12 may include the wire composite ring 124. The wire composite ring 124 is fixedly connected to the positioning member 12 and is located on the side of the positioning member 12 facing the highly elastic anti-reflux cardiac valve stent. The wire composite ring 124 may include a first through hole 1241 and a second through hole 1242. The first through hole 1241 is used for installing a marker, and the second through hole 1242 is adapted to penetrate a wire. Moreover, the second through hole 1242 is closer to the proximal end of the cardiac valve stent than the first through hole 1241. In a specific embodiment, the aperture of the first through hole 1241 is larger than that of the second through hole 1242. The structure of the wire composite ring 124 provided at the distal end of the positioning member 12 combines the installation of the wire and the marker (the marker is radio-opaque) into one position, effectively reducing the space occupancy of the product. Using one position, the opening and closing control and positioning of the positioning member 12 can be achieved. This not only improves the compression performance of the product and facilitates the delivery of the product using a catheter, but also the positioning member 12 can control the opening angle, which is also beneficial for reducing the difficulty of the surgical operation. The wire composite ring 124 structure has two through holes. The large hole is for placing the marker point to facilitate accurate positioning during implantation to ensure that the positioning member touches the sinus bottom. The small hole is convenient for threading the wire. During the implantation process, the opening angle of the positioning member 12 is controlled by the wire, which is convenient for capturing the valve leaflets and reduces the operation difficulty. In a preferred embodiment, the wire composite ring 124 is provided inside the distal end of the positioning member 12 (inside refers to the opening direction of the positioning member 12) and is inclined inward relative to the stent axis to prevent the proximal end of the wire composite ring from colliding with the aortic wall during the shaking of the stent, thereby damaging the aorta. Seriously, it may cause aortic dissection in the user and threaten the life of the user.

[0069] Next, more details and features of the reinforcing mesh 13 will be described.

[0070] In this embodiment, the reinforcing mesh 13 can be used to clamp the native leaflets together with the positioning member 12. In this embodiment, the reinforcing mesh 13 can include a quadrilateral grid unit 131. In this embodiment, the reinforcing mesh 13 can only include a first quadrilateral grid unit 1131, and the first quadrilateral grid unit 131 is formed by connecting a first link 1301, a second link 1302, a third link 1303, and a fourth link 1304. The proximal end of the first link 1301 is fixedly connected to the distal end of the second link 1302, and the proximal end of the fourth link 1304 is fixedly connected to the distal end of the third link 1303. In this embodiment, the distal ends of the first link 1301 and the fourth link 1304 are fixedly connected to the connecting member 14, and the proximal ends of the second link 1302 and the third link 1303 are fixedly connected to the distal end of the diamond grid unit 161 of the clamping end 16. After the valve stent is implanted at the aortic valve, the valve stent will bear the reverse flow pressure from the aortic blood flow. At this time, the aortic regurgitant blood will impact the artificial leaflet. The distal end of the artificial leaflet mainly functions to close and will not bear a large amount of force perpendicular to the axis of the stent. While the bottom (proximal end) of the artificial leaflet is completely sealed to form a blocking surface, so the bottom of the artificial leaflet will be subjected to a relatively large force perpendicular to the axis of the stent. Therefore, when the bottom (proximal end) of the artificial leaflet is impacted by the blood flow, it will drive the clamping end 16 to move towards the ventricle direction. The clamping end 16 will transmit the force to the positioning member 12 through the reinforcing mesh 13, and the positioning member 12 will ensure that the clamping end 16 does not move downwards by force. And the reinforcing mesh 13 of this designed stent is composed of the quadrilateral grid unit 131. The first link 1301 and the second link 1302 form an elastic curved side, and the third link 1303 and the fourth link 1304 form another elastic curved side. At this time, when the clamping end 16 is suddenly impacted, the reinforcing mesh 13 relatively elastically deforms and elongates, buffering the large inertial force generated by the clamping end 16, reducing the impact force transmitted by the clamping end 16 to the positioning member 12, thereby reducing the impact damage of the proximal end of the positioning member 12 to the bottom of the aortic sinus.

[0071] In this article, for the convenience of description, the links constituting the quadrilateral grid unit 131 are collectively referred to as reinforcing mesh links. The quadrilateral grid unit 131 can be composed of reinforcing mesh links, and the reinforcing mesh links are thin in the middle and wide at both ends. Such a structure can optimize the anti-fatigue performance of the highly elastic anti-regurgitation heart valve stent and improve the resilience performance of the highly elastic anti-regurgitation heart valve stent.

[0072] Next, more details and features of the clamping end 16 will be described.

[0073] The proximal end of the highly elastic anti-reflux heart valve stent may include a clamping end 16, and the clamping end 16 may include at least one layer of interconnected diamond grid units 161. The width of the clamping end link 162 that constitutes the structural unit 161 of the clamping end is small in the middle and large at both ends. As Figure 1 and Figure 2 shown, the rod 162 of the structural unit 161 of the clamping end may be symmetric, with the smallest width in the middle and then smoothly increasing towards both ends without stepped mutations. Therefore, the edges of the rod 162 are smooth. In a specific embodiment, the structural unit 161 of the clamping end is a diamond grid, and the clamping end 16 may include 18 interconnected structural units 161 of the clamping end arranged in one layer. Adjacent structural units 161 of the clamping end may be interconnected by sharing a vertex. The connection regions 164 of the structural units of the clamping end extend a predetermined length along the circumferential and longitudinal directions of the highly elastic anti-reflux heart valve stent respectively.

[0074] The distal end of the clamping end 16 expands outward relative to the proximal end of the clamping end 16, and the angle of outward expansion of the distal end of the clamping end 16 relative to the proximal end of the clamping end 16 is 6° - 14°. The reason for the need for outward expansion is to prevent the anti-reflux stent from displacing towards the aorta and cooperate with the aortic valve annulus to play an anchoring role. The reason for not allowing too large an angle is to prevent the clamping end extending into the heart from touching the His bundle, thus affecting the normal beating of the heart and endangering life.

[0075] Next, more details and technical features of the connecting member 14 will be described.

[0076] Returning to Figure 1 , 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 used to connect with the delivery device for delivering the heart valve stent. The distal end of the connecting frame 143 is fixedly connected to the distal ends of the first positioning arm 121 and the second positioning arm 122, and the proximal end of the connecting frame 143 is fixedly connected to the distal end of the quadrilateral grid unit 131 of the strengthening mesh 13. This can prevent the positioning member 12 and the strengthening mesh 13 from generating shear force on the native leaflets and causing secondary damage.

[0077] 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 close to the distal end of the connecting frame 143, and the other end is close to the proximal end of the connecting frame 143. The elongated suture hole 144 enables the proximal edge of the artificial leaflet to be directly sutured through the suture hole without adding a suture gasket. The edge of the artificial leaflet is sutured and connected to the membrane inside the stent. The membrane is arranged inside the stent of this design, that is, on the inner surface of the clamping end 16 and the reinforcing mesh 13, that is, the surface facing the axis of the stent. Relative to the method of suturing the artificial leaflet to the stent, the artificial leaflet is sutured to the membrane. The membrane has a wide connection area and is flexibly designed to suture the artificial leaflet. The material of the membrane can be made of high molecular materials such as PET (polyethylene terephthalate) or PTFE (polytetrafluoroethylene) or animal pericardial biological tissue. The membrane covers the inner surface of the stent of this design to prevent blood leakage and achieve a sealing effect; the material of the artificial leaflet can include one or more synthetic materials, engineered biological tissues, biological leaflet tissues, pericardial tissues, cross-linked pericardial tissues, aortic root tissues, tissues processed / treated by chemical or biological methods, or combinations thereof. Further, the pericardial tissue can be selected from the group consisting of, but not limited to, tissues of cows, horses, pigs, sheep, and humans or combinations thereof. Such a suturing method, compared with the traditional method of using a gasket to squeeze and fix the leaflet with the heart valve stent, first reduces the additional components outside the heart valve stent, and without the gasket, it is also beneficial to the further compression of the heart valve stent. If there is a gasket, it not only affects the stent compression, but sometimes damages the artificial leaflet when the compressed size of the stent is small.

[0078] Example 2

[0079] This embodiment provides a highly elastic anti-reflux heart valve stent. The highly elastic anti-reflux heart valve stent includes a support member 11, and its reinforcing mesh 13 includes a quadrilateral grid unit 161.

[0080] Reference Figure 3 and Figure 4, the highly elastic anti-reflux heart valve stent of this embodiment includes a support member 11, a positioning member 12, a reinforcing mesh 13, a connecting member 14, and a clamping end 16. The distal end of the highly elastic anti-reflux heart valve stent of this embodiment further includes a support member 11 disposed between adjacent connecting members 14. The support member 11 is closer to the distal end of the highly elastic anti-reflux heart valve stent than the positioning member 12 and is used to fix the native valve leaflets. The support member 11 may include a first support arm 111, a second support arm 112, and a distal end 113 of the support member that connects the first support arm 111 and the second support arm 112 and protrudes toward the proximal end of the highly elastic anti-reflux heart valve stent. The first support arm 111 is fixedly connected to a first connecting member, the second support arm 112 is fixedly connected to a second connecting member, and the first connecting member is adjacent to the second connecting member.

[0081] In this embodiment, the positioning member 12 is closer to the distal end of the highly elastic anti-reflux heart valve stent than the support member 11. The distal end 113 of the support member and the distal end 123 of the positioning member are rods that protrude toward the distal end of the heart valve stent. The support member 11 is disposed on one side of the native heart valve leaflets, and the positioning member 12 is disposed on the other side of the native heart valve leaflets.

[0082] Compared with traditional heart valve stents, the heart valve stent described herein further includes a support member 11, so that the native valve leaflets can be clamped between the support member 11 and the positioning member 12. The support member 11 prevents the native valve leaflets from interfering with the artificial valve leaflets. Moreover, since the native valve leaflets are clamped by the support member 11 and the positioning member 12, the clamping is relatively more secure. At the same time, the support member 11 also facilitates the more smooth self-expansion of the highly elastic anti-reflux heart valve stent, increasing the radial force during self-expansion.

[0083] In a specific embodiment, referring to Figure 4 , when the highly elastic anti-reflux heart valve stent is in a compressed state, the first support arm 111 and the second support arm 112 are linear. The first positioning arm 111 and the second positioning arm 112 are designed to be linear to facilitate the compression of the highly elastic anti-reflux heart valve stent. When the highly elastic anti-reflux heart valve stent is fully compressed, the space it occupies is the smallest, that is, the adjacent first support arm 111 and the second support arm 112 will fully close together during compression. The purpose of the first support arm 111 and the second support arm 112 being linear is that they will fully close together without interference during compression. In addition, the highly elastic anti-reflux heart valve stent of this embodiment can be cut from a single nitinol tube. The linear design is also conducive to processing, shortening the processing path and reducing the processing cost.

[0084] In this embodiment, the connecting member 14 may include a connecting block 141, a connecting web 142, and a connecting frame 143. One end of the connecting block 141 forms the proximal end of the anti-reflux heart valve stent, and the other end is connected to the connecting frame 143 through the connecting web 142. The distal end of the connecting frame 143 is fixedly connected to the distal ends of the first support arm 111 and the second support arm 112, and the proximal end of the connecting frame 143 is fixedly connected to the distal ends of the first positioning arm 121, the second positioning arm 122, and the quadrilateral mesh unit 131 of the reinforcing mesh 13.

[0085] In this embodiment, similar to Embodiment 1, a wire composite loop 124 is provided on the positioning member 12, and the connecting frame 143 includes a hollow elongated suture hole 144. The features of the positioning member 12, the reinforcing mesh 13, the clamping end 16, the wire composite loop 124, the connecting block 141, the connecting web 142, and the elongated suture hole 144 that are not described in detail in this embodiment are the same as those in Embodiment 1 and will not be elaborated here.

[0086] Embodiment 3

[0087] This embodiment provides a highly elastic anti-reflux heart valve stent. The reinforcing mesh 13 of the highly elastic anti-reflux heart valve stent includes a first quadrilateral mesh unit 131 and a second quadrilateral mesh unit 132.

[0088] Reference Figure 5 and Figure 6 , the reinforcing mesh 13 of the highly elastic anti-reflux heart valve stent in this embodiment includes a first quadrilateral mesh unit 131 and a second quadrilateral mesh unit 132. The first quadrilateral mesh unit 131 is formed by connecting a first link 1301, a second link 1302, a third link 1303, and a fourth link 1304. The proximal end of the first link 1301 is fixedly connected to the distal end of the second link 1302, and the proximal end of the fourth link 1304 is fixedly connected to the distal end of the third link 1303. The second quadrilateral mesh unit 132 is formed by connecting a fifth link 1305, a sixth link 1306, a seventh link 1307, and an eighth link 1308. The proximal end of the fifth link 1305 is fixedly connected to the distal end of the sixth link 1306, and the proximal end of the eighth link 1308 is fixedly connected to the distal end of the seventh link 1307. In this embodiment, the distal ends of the first link 1301 and the fourth link 1304 are fixedly connected to the connecting member 14, the proximal ends of the sixth link 1306 and the seventh link 1307 are fixedly connected to the distal end of the diamond mesh unit 161, and the second link 1302, the third link 1303, the fifth link 1305, and the eighth link 1308 share a vertex.

[0089] The reinforcement mesh 13 may include one, two or three layers of quadrilateral mesh units 131, and preferably may include two layers of quadrilateral mesh units 131. The positioning member 12 needs to ensure a certain length, that is, to ensure that the distal end 123 of the positioning member can be fully inserted into the sinus floor. Therefore, this highly elastic anti-reflux heart valve stent must have a certain axial length. When the reinforcement mesh 13 only contains one quadrilateral mesh unit 131, it is easy to cause insufficient torsional resistance at the proximal end and the distal end of the highly elastic anti-reflux heart valve stent, resulting in easy torsion of the highly elastic anti-reflux heart valve stent and bending of the whole highly elastic anti-reflux heart valve stent. In addition, in the embodiment where the reinforcement mesh 13 only contains one quadrilateral mesh unit 131, the connecting rod of the reinforcement mesh 13 is too long, and the deformation is large during heat setting and compression, and it is not easy to control its deformation trajectory.

[0090] However, adopting the structure of two layers of quadrilateral mesh units 131 can effectively reduce the distance between the proximal end and the distal end of the connecting rod of the reinforcement mesh of each quadrilateral mesh unit 131, and increase the controllability of the deformation of the quadrilateral mesh unit 131.

[0091] The features of the positioning member 12, the connecting member 14, the clamping end 16, and the wire-pulling composite ring 124 not described in detail in this embodiment are the same as those in Embodiment 1, and will not be elaborated here.

[0092] Embodiment 4

[0093] This embodiment provides a highly elastic anti-reflux heart valve stent. The reinforcement mesh 13 of this highly elastic anti-reflux heart valve stent includes a first quadrilateral mesh unit 131 and a second quadrilateral mesh unit 132. In addition, the highly elastic anti-reflux heart valve stent of this embodiment further includes a support member 11.

[0094] Reference Figure 7 and Figure 8, compared with the highly elastic anti-reflux heart valve stent of Embodiment 2, the highly elastic anti-reflux heart valve stent of this embodiment is characterized in that the strengthening mesh 13 of the highly elastic anti-reflux heart valve stent of this embodiment includes a first quadrilateral mesh unit 131 and a second quadrilateral mesh unit 132. The first quadrilateral mesh unit 131 is formed by connecting a first link 1301, a second link 1302, a third link 1303, and a fourth link 1304. The proximal end of the first link 1301 is fixedly connected to the distal end of the second link 1302, and the proximal end of the fourth link 1304 is fixedly connected to the distal end of the third link 1303. The second quadrilateral mesh unit 132 is formed by connecting a fifth link 1305, a sixth link 1306, a seventh link 1307, and an eighth link 1308. The proximal end of the fifth link 1305 is fixedly connected to the distal end of the sixth link 1306, and the proximal end of the eighth link 1308 is fixedly connected to the distal end of the seventh link 1307. In this embodiment, the distal ends of the first link 1301 and the fourth link 1304 are fixedly connected to the connecting member 14, the proximal ends of the sixth link 1306 and the seventh link 1307 are fixedly connected to the distal end of the diamond mesh unit 161 of the clamping end 16, and the second link 1302, the third link 1303, the fifth link 1305, and the eighth link 1308 share a vertex.

[0095] The features of the support member 11, the positioning member 12, the connecting member 14, the clamping end 16, and the wire composite ring 124 not described in detail in this embodiment are the same as those in Embodiment 2 and will not be elaborated here.

[0096] Embodiment 5

[0097] This embodiment provides a highly elastic anti-reflux heart valve stent. The strengthening mesh 13 of the highly elastic anti-reflux heart valve stent includes a first quadrilateral mesh unit 131, a second quadrilateral mesh unit 132, and two third quadrilateral mesh units 133.

[0098] Reference Figures 9 - 13 , compared with Embodiment 3, the strengthening mesh 13 of this embodiment further includes two third quadrilateral mesh units 133, which are symmetrically arranged on both sides of the second quadrilateral mesh unit 132. The proximal ends of the third quadrilateral mesh units 133 are fixedly connected to the distal end of the diamond mesh unit 161 of the clamping end 16, but the distal ends of the third quadrilateral mesh units 133 are free ends.

[0099] Specifically, the third quadrilateral mesh unit 133 can be formed by connecting the ninth link 1309, the tenth link 1310, the eleventh link 1311, and the twelfth link 1312. The proximal end of the ninth link 1309 is fixedly connected to the distal end of the tenth link 1310, and the proximal end of the twelfth link 1312 is fixedly connected to the distal end of the eleventh link 1311. For the third quadrilateral mesh unit 133 disposed on the left side of the second quadrilateral mesh unit 132, the eleventh link 1311 and the twelfth link 1312 of the third quadrilateral mesh unit 133 share a vertex with the fifth link 1305 and the sixth link 1306 of the second quadrilateral mesh unit 132. For the third quadrilateral mesh unit 133 disposed on the right side of the second quadrilateral mesh unit 132, the ninth link 1309 and the tenth link 1310 of the third quadrilateral mesh unit 133 share a vertex with the seventh link 1307 and the eighth link 1308 of the second quadrilateral mesh unit 132. At the same time, the distal end of the ninth link 1309 is fixedly connected to the distal end of the twelfth link 1312 and is not connected to other components of the highly elastic anti-reflux heart valve stent, forming the free end of the third quadrilateral mesh unit 133. The proximal ends of the tenth link 1310 and the eleventh link 1311 are fixedly connected and share a vertex with the distal end of the diamond mesh unit 161 of the clamping end 16.

[0100] In this embodiment, the number of two layers of quadrilateral mesh units 131 increases in the direction from the distal end to the proximal end of the highly elastic anti-reflux heart valve stent (preferably increasing by 2 for each layer), and the proximal ends of the upper-layer quadrilateral mesh units 131 are connected to the distal ends of the lower-layer quadrilateral mesh units 131, rather than crossing to form a network structure. The overall outer contour of the reinforcing mesh 13 approximately forms a triangular-like reinforcing mesh 13, which can effectively increase the stability between the proximal end and the distal end of the highly elastic anti-reflux heart valve stent. This embodiment is illustrated with the reinforcing mesh 13 having two layers of quadrilateral mesh units. The number of quadrilateral mesh units in each layer from the distal end to the proximal end of the reinforcing mesh 13 is 1 and 3 respectively. In other embodiments, it can also be 1 and 5, etc.

[0101] Furthermore, when the reinforcing mesh 13 is provided with multiple layers of quadrilateral mesh units 131, at least one layer of quadrilateral mesh units 131 is 1, so as to ensure that at least one layer of quadrilateral mesh units 131 of the reinforcing mesh 13 is elastic in the axial direction. Because designing multiple quadrilateral mesh units 131 in one layer of the reinforcing mesh will inevitably lead to a decrease in its axial elastic force, affecting the shock-absorbing effect of the reinforcing mesh 13 on the positioning member 12. Therefore, it is necessary to ensure that at least one layer of quadrilateral mesh units 131 of the reinforcing mesh 13 is 1;

[0102] In some embodiments, the reinforcement mesh 13 has multiple layers (more than two layers) of quadrilateral mesh units. From the distal end to the proximal end of the reinforcement mesh 13, the number of quadrilateral mesh units 131 in each layer may not all increase, but some may remain equal. For example, from the distal end to the proximal end of the reinforcement mesh 13, the number of quadrilateral mesh units 131 in each layer is 1, 3, 3 respectively, or 1, 1, 3, or 1, 1, 5.

[0103] The features of the positioning member 12, the connecting member 14, the clamping end 16, and the wire-pulling composite ring 124 not described in detail in this embodiment are the same as those in Embodiment 1 and will not be elaborated here.

[0104] Embodiment 6

[0105] This embodiment provides a highly elastic anti-reflux heart valve stent. The reinforcement mesh 13 of the highly elastic anti-reflux heart valve stent includes a first quadrilateral mesh unit 131, a second quadrilateral mesh unit 132, and two third quadrilateral mesh units 133. In addition, the highly elastic anti-reflux heart valve stent of this embodiment further includes a support member 11.

[0106] Reference Figure 14 and 15 , compared with Embodiment 4, the reinforcement mesh 13 of this embodiment further includes two third quadrilateral mesh units 133, which are symmetrically arranged on both sides of the second quadrilateral mesh unit 132. The proximal end of the third quadrilateral mesh unit 133 is fixedly connected to the distal end of the diamond mesh unit 161 of the clamping end 16, but the distal end of the third quadrilateral mesh unit 133 is a free end.

[0107] Specifically, the third quadrilateral mesh unit 133 can be formed by connecting the ninth link 1309, the tenth link 1310, the eleventh link 1311, and the twelfth link 1312. The proximal end of the ninth link 1309 is fixedly connected to the distal end of the tenth link 1310, and the proximal end of the twelfth link 1312 is fixedly connected to the distal end of the eleventh link 1311. For the third quadrilateral mesh unit 133 disposed on the left side of the second quadrilateral mesh unit 132, the eleventh link 1311 and the twelfth link 1312 of the third quadrilateral mesh unit 133 share a vertex with the fifth link 1305 and the sixth link 1306 of the second quadrilateral mesh unit 132. For the third quadrilateral mesh unit 133 disposed on the right side of the second quadrilateral mesh unit 132, the ninth link 1309 and the tenth link 1310 of the third quadrilateral mesh unit 133 share a vertex with the seventh link 1307 and the eighth link 1308 of the second quadrilateral mesh unit 132. At the same time, the distal end of the ninth link 1309 is fixedly connected to the distal end of the twelfth link 1312 and is not connected to other components of the highly elastic anti-reflux heart valve stent, forming the free end of the third quadrilateral mesh unit 133. The proximal ends of the tenth link 1310 and the eleventh link 1311 are fixedly connected and share a vertex with the distal end of the diamond mesh unit 161 of the clamping end 16.

[0108] In this embodiment,

[0109] In this embodiment, the number of two layers of quadrilateral mesh units 131 increases in the direction from the distal end to the proximal end of the highly elastic anti-reflux heart valve stent (preferably increasing by 2 for each layer), and the proximal end of the upper-layer quadrilateral mesh unit 131 in them is connected to the distal end of the lower-layer quadrilateral mesh unit 131, rather than crossing to form a network structure. The overall outer contour of the reinforcement net 13 approximately forms a triangular-like reinforcement net 13, which can effectively increase the stability between the proximal end and the distal end of the highly elastic anti-reflux heart valve stent. This embodiment is illustrated as having two layers of quadrilateral mesh units in the reinforcement net 13, and the number of quadrilateral mesh units in each layer from the distal end to the proximal end of the reinforcement net 13 is 1 and 3 respectively. In other embodiments, it can also be 1 and 5, etc.

[0110] Furthermore, when multiple layers of quadrilateral mesh units 131 are provided in the reinforcement net 13, at least one layer of quadrilateral mesh units 131 is 1, so as to ensure that at least one layer of quadrilateral mesh units 131 in the reinforcement net 13 is elastic in the axial direction. Because designing multiple quadrilateral mesh units 131 in one layer of the reinforcement net will inevitably lead to a decrease in its axial elastic force, affecting the shock-absorbing effect of the reinforcement net 13 on the positioning member 12. Therefore, it is necessary to ensure that at least one layer of quadrilateral mesh units 131 in the reinforcement net 13 is 1.

[0111] In some embodiments, the reinforcing mesh 13 has multiple layers (more than two layers) of quadrilateral mesh units. From the distal end to the proximal end of the reinforcing mesh 13, the number of quadrilateral mesh units 131 in each layer may not all increase, but some may remain equal. For example, from the distal end to the proximal end of the reinforcing mesh 13, the number of quadrilateral mesh units 131 in each layer is 1, 3, 3 respectively, or 1, 1, 3, or 1, 1, 5.

[0112] The features of the support member 11, the positioning member 12, the connecting member 14, the clamping end 16, and the wire-pulling composite ring 124 not described in detail in this embodiment are the same as those in Embodiment 2 and will not be elaborated here.

[0113] Embodiment 7

[0114] This embodiment provides a highly elastic anti-reflux heart valve stent, the structure of which is similar to the highly elastic anti-reflux heart valve stent described in Embodiment 5. The difference is only that the first positioning arm 121 and the second positioning arm 122 of the positioning member 12 are curved. Specifically, the first positioning arm 121 may include a first positioning arm convex portion 125 protruding toward the adjacent connecting member, and the second positioning arm 122 may include a second positioning arm convex portion 126 protruding toward the adjacent connecting member. Compared with the traditional linearly cut positioning member 12, the positioning member 12 formed by curved cutting can cut out a longer positioning member 12 when the length of the nitinol tube is the same. This can effectively increase the axial length of the positioning member 12 in the unfolded state. In other words, for a highly elastic anti-reflux heart valve stent of a certain length, when the highly elastic anti-reflux heart valve stent is in the unfolded state, the positioning member 12 formed by curved cutting is relatively straight and can be inserted deeper into the bottom of the aortic sinus.

[0115] The above description of the embodiments is for the convenience of those of ordinary skill in the art to understand and apply the present application. Those skilled in the art can obviously make various modifications to these embodiments easily and apply the general principles described herein to other embodiments without creative efforts. Therefore, the present application is not limited to the embodiments here. Improvements and modifications made by those skilled in the art within the scope and spirit of the present application based on the content disclosed in the present application are within the scope of the present application.

Claims

1. A highly elastic anti-reflux cardiac valve stent, the highly elastic anti-reflux cardiac valve stent comprising a proximal end of the highly elastic anti-reflux cardiac valve stent and a distal end of the highly elastic anti-reflux cardiac valve stent, characterized in that, The distal end of the highly elastic anti-reflux heart valve stent includes a positioning member disposed between adjacent connecting members. The positioning member is used to position the highly elastic anti-reflux heart valve stent. The positioning member includes a first positioning arm, a second positioning arm, and a distal end of the positioning member that is parabolic and protrudes toward the proximal end of the highly elastic anti-reflux heart valve stent, connecting the first positioning arm and the second positioning arm. The proximal end of the highly elastic anti-reflux heart valve stent includes a clamping end, which includes at least one layer of interconnected diamond grid units. The distal end of the clamping end expands outward relative to the proximal end of the clamping end, and the angle of outward expansion of the distal end of the clamping end relative to the proximal end of the clamping end is 6°-14°. The vertical distance from the distal end of the positioning member to the distal end of the clamping end is 2 mm - 8 mm. The highly elastic anti-reflux heart valve stent further includes a reinforcing mesh, which includes at least one quadrilateral grid unit that is elliptical or diamond-shaped when the highly elastic anti-reflux heart valve stent is extended. One end of the reinforcing mesh is fixedly connected to the connecting member of the highly elastic anti-reflux heart valve stent, and the other end is fixedly connected to the distal end of the diamond grid unit. The reinforcing mesh connecting rod of the quadrilateral grid unit and the clamping end connecting rod of the diamond grid unit are both structures that are narrow in the middle and wide at both ends. The reinforcing mesh and the positioning member clamp the native leaflets together.

2. The highly elastic anti-reflux cardiac valve stent according to claim 1, wherein The reinforcing mesh includes a first quadrilateral grid unit, which is formed by connecting a first connecting rod, a second connecting rod, a third connecting rod, and a fourth connecting rod. The proximal end of the first connecting rod is fixedly connected to the distal end of the second connecting rod, and the proximal end of the fourth connecting rod is fixedly connected to the distal end of the third connecting rod. Wherein the distal ends of the first connecting rod and the fourth connecting rod are fixedly connected to the connecting member, and the proximal ends of the second connecting rod and the third connecting rod are fixedly connected to the distal end of the diamond grid unit.

3. The highly elastic anti-reflux cardiac valve stent according to claim 2, wherein The reinforcing mesh includes a first quadrilateral grid unit and a second quadrilateral grid unit. The first quadrilateral grid unit is formed by connecting a first connecting rod, a second connecting rod, a third connecting rod, and a fourth connecting rod. The proximal end of the first connecting rod is fixedly connected to the distal end of the second connecting rod, and the proximal end of the fourth connecting rod is fixedly connected to the distal end of the third connecting rod. The second quadrilateral grid unit is formed by connecting a fifth connecting rod, a sixth connecting rod, a seventh connecting rod, and an eighth connecting rod. The proximal end of the fifth connecting rod is fixedly connected to the distal end of the sixth connecting rod, and the proximal end of the eighth connecting rod is fixedly connected to the distal end of the seventh connecting rod. Wherein the distal ends of the first connecting rod and the fourth connecting rod are fixedly connected to the connecting member, the proximal ends of the sixth connecting rod and the seventh connecting rod are fixedly connected to the distal end of the diamond grid unit, and the second connecting rod, the third connecting rod, the fifth connecting rod, and the eighth connecting rod share a vertex.

4. The highly elastic anti-reflux cardiac valve stent according to claim 3, wherein The reinforcing mesh further includes two third quadrilateral mesh units, which are symmetrically arranged on both sides of the second quadrilateral mesh unit. One side of the third quadrilateral mesh unit close to the second quadrilateral mesh unit shares a vertex with the second quadrilateral mesh unit. The proximal end of the third quadrilateral mesh unit is fixedly connected to the distal end of the diamond mesh unit, and the distal end of the third quadrilateral mesh unit is a free end.

5. The highly elastic anti-reflux cardiac valve stent according to claim 4, wherein When there are two layers of the quadrilateral mesh units, the number of the quadrilateral mesh units increases in the direction from the distal end to the proximal end of the highly elastic anti-reflux heart valve stent.

6. The highly elastic anti-reflux cardiac valve stent according to claim 5, characterized in that, The reinforcing mesh is provided with multiple layers of quadrilateral mesh units, and at least one layer of the quadrilateral mesh units is one.

7. The highly elastic anti-reflux cardiac valve stent according to claim 6, wherein The reinforcing mesh has at least three layers of quadrilateral mesh units. From the distal end to the proximal end of the reinforcing mesh, the number of quadrilateral mesh units in each layer does not all increase, but some remain equal.

8. The highly elastic anti-reflux cardiac valve stent according to claim 1, wherein The first positioning arm and the second positioning arm are linear or curved.

9. The highly elastic anti-reflux cardiac valve stent according to claim 1, characterized in that, When the highly elastic anti-reflux heart valve stent is extended, the opening angle of the positioning member is 2°-14°.

10. The highly elastic anti-reflux cardiac valve stent according to claim 8, characterized in that, 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 anti-reflux heart valve stent, and the other end is connected to the connecting frame through the connecting web. The distal end of the connecting frame is fixedly connected to the distal ends of the first positioning arm and the second positioning arm, and the proximal end of the connecting frame is fixedly connected to the distal end of the quadrilateral mesh unit.

11. The highly elastic anti-reflux heart valve stent according to claim 10, characterized in that, The connecting frame includes a long strip-shaped suture hole suitable for an artificial valve leaf to pass through. One end of the long strip-shaped suture hole is close to the distal end of the connecting frame, and the other end is close to the proximal end of the connecting frame.

12. The highly elastic anti-reflux heart valve stent according to any one of claims 1-11, characterized in that, The distal end of the highly elastic anti-reflux heart valve stent further includes a support member arranged between adjacent connecting members. The support member is closer to the distal end of the highly elastic anti-reflux heart valve stent than the positioning member and is used for fixing the native valve leaf. The support member includes a first support arm, a second support arm and a distal end of the support member that connects the first support arm and the second support arm and protrudes towards the proximal end of the highly elastic anti-reflux heart valve stent.

13. The highly elastic anti-reflux cardiac valve stent according to claim 12, wherein 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 anti-reflux heart valve stent, and the other end is connected to the connecting frame through the connecting web. The distal end of the connecting frame is fixedly connected to the distal ends of the first support arm and the second support arm, and the proximal end of the connecting frame is fixedly connected to the distal ends of the first positioning arm, the second positioning arm and the quadrilateral mesh unit.

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