WO2022022574A1

WO2022022574A1 - Prosthetic valve

Info

Publication number: WO2022022574A1
Application number: PCT/CN2021/108949
Authority: WO
Inventors: 周庆亮; 刘岩; 刘晓芳; 史欢欢; 孟坚
Original assignee: 北京迈迪顶峰医疗科技股份有限公司
Priority date: 2020-07-28
Filing date: 2021-07-28
Publication date: 2022-02-03

Abstract

A prosthetic valve, comprising: a stent (10), the stent (10) comprising a first grid section (11), a second grid section (12) and a limiting section (13) which are connected to each other, with the second grid section (12) being located between the first grid section (11) and the limiting section (13), the second grid section (12) forming a barrel-shaped structure in an enclosed manner, the diameter of the first grid section (11) increasing in the direction from a position close to the second grid section (12) to a position away from the second grid section (12), and the limiting section (13) having an outward turning edge; a sealing membrane (20), the sealing membrane (20) being arranged on the stent (10); and a valve leaflet (30), the valve leaflet (30) being arranged on the second grid section (12) so as to make fluid flow in the direction from the first grid section (11) to the limiting section (13). The prosthetic valve effectively solves the problems of the circumferential positioning and fixing of an existing interventional tricuspid valve.

Description

artificial valve

technical field

The present invention relates to the technical field of artificial prosthesis devices, in particular, to an artificial valve.

Background technique

The natural heart valves (aortic, pulmonary, tricuspid and mitral) play a very important role in ensuring the supply of blood to the body.

Prosthetic valves are used to treat valvular heart disease. When there is a problem with the natural heart valve, the artificial valve is used to replace the natural valve. Since the tricuspid valve annulus is a "D"-shaped structure, and there is a coronary sinus between the inferior vena cava and the tricuspid valve orifice, accurate circumferential positioning is particularly important for the prosthetic valve for tricuspid valve replacement; and, While ensuring the accurate positioning of the valve, it is also an essential requirement for the tricuspid valve to effectively avoid the coronary sinus and fix it firmly.

SUMMARY OF THE INVENTION

The main purpose of the present invention is to provide a tricuspid valve valve, the distal developing point can solve the problem of inaccurate circumferential positioning of the tricuspid valve valve in the prior art; On the other hand, the valve is fixed. At the same time, the valve's own gap design can avoid blocking the coronary sinus after implantation and ensure the normal function of the valve.

In order to achieve the above object, the present invention provides an artificial valve, comprising: a stent, the stent includes a first grid segment, a second grid segment and a limit segment that are connected to each other, and the second grid segment is located between the first grid segment and the limit segment. During the time, the second grid segment is surrounded by a barrel-shaped structure, the diameter of the first grid segment increases from the direction close to the second grid segment to the direction away from the second grid segment, and the first grid segment has an avoidance gap, and the limit segment has an outward The sealing film, the sealing film is arranged on the support; the valve leaflet, the valve leaflet is arranged on the second grid segment, so that the flow direction of the fluid is from the first grid segment to the limit segment.

Further, the limiting segment is connected to the second grid segment, the limiting segment is at least one "U"-shaped structure, the middle of the limiting segment extends toward the first grid segment, and the two ends of the "U"-shaped structure are respectively connected to the second grid segment. Mesh segments are connected.

Further, the limiting segment is a plurality of "U"-shaped structures, and the plurality of "U"-shaped structures are evenly distributed at the first end of the second grid segment.

Further, there are three "U"-shaped structures and three valve leaflets, and the three valve leaflets are arranged in a one-to-one correspondence with the three "U"-shaped structures.

Further, the first grid segment is a bell mouth structure, and the first grid segment is composed of two, three or multiples of three petal-shaped support bars, and the support bars are evenly arranged in the circumferential direction.

Further, the avoidance gap of the first grid segment is a fan-shaped structure.

Further, the bracket further includes a plurality of connecting ears, and the plurality of connecting ears are arranged on the first end of the first mesh segment.

Further, the stent is made by a cutting process or a weaving process.

Further, the bracket further includes barbs connected to the second mesh segment and extending in a direction away from the central axis of the second mesh segment.

Further, the barbs extend obliquely toward the direction of the first mesh segment.

Further, there are a plurality of barbs, the angle between the barbs and the outer side wall of the second grid segment is between 10 degrees and 80 degrees, and the length of the barbs is 1 mm to 10 mm.

Further, the artificial valve further includes a developing part, and the developing part is arranged on the stent.

Further, the developing component is located at the apex of the outward flange of the limiting section, and the developing component on at least one apex is different from other apexes, and can be used to distinguish the circumferential positioning of the valve.

Further, the first mesh segment is provided with a sealing film, the first mesh segment has an avoidance notch, and the developing member is arranged corresponding to the avoidance notch.

Further, the cross section of the second mesh segment is "D" shaped.

Further, the vertices of the outward flanging of the limiting segment are respectively provided with three developing points, wherein the avoiding gap of the first mesh segment is provided with three developing points at the developing points of the vertices of the flanging corresponding to the axial direction, Easy to show location. As shown in the figure, the number of developing points is different at the three developing places.

By applying the technical scheme of the present invention, the artificial valve is delivered to the right ventricle beyond the target position by the delivery device, and the limit segment is first released. The "D"-shaped structure after valve release can correspond to the "D"-shaped annulus of the tricuspid valve. When the artificial valve is withdrawn as a whole, the flanging of the limiting segment will interact with the native valve leaflets or chordae tendineae to form a blocking limit. The delivery device then releases the second mesh segment, which increases in diameter and has barbs and is caught in the tricuspid annulus. Finally, the first mesh segment is released, and the diameter of the first mesh segment increases from the direction close to the second mesh segment to the direction away from the second mesh segment, so that the first mesh segment will form a limit in the other direction to prevent the valve from falling into the right ventricle . The above structure enables the artificial valve to have a better fixation effect at the tricuspid valve. The technical scheme of the present invention effectively solves the problems of the adaptability and circumferential positioning of the artificial valve and human organs.

Description of drawings

The accompanying drawings forming a part of the present application are used to provide further understanding of the present invention, and the exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the attached image:

Figures 1A and 1B show schematic front views of an embodiment of a prosthetic valve according to the present invention;

Figure 2 shows a schematic top view of the prosthetic valve of Figure 1;

3 shows a schematic top view of the artificial valve according to another embodiment of the artificial valve of the present invention;

Figure 4 shows a schematic front view of the stent of the prosthetic valve of Figure 1;

FIG. 5 shows a schematic top view of the bracket of FIG. 4; and

FIG. 6 shows a schematic structural diagram of another embodiment of the stent of the artificial valve of the present invention;

7 shows a schematic diagram of the implantation of a prosthetic valve in a human body according to the present disclosure;

FIG. 8 shows a schematic diagram of an exemplary delivery tool for implanting a prosthetic valve according to the present disclosure; and

Figure 9 shows a schematic diagram of the release of the limiting segment during implantation of the prosthetic valve.

Wherein, the above-mentioned drawings include the following reference signs:

10, bracket; 11, first mesh segment; 12, second mesh segment; 13, limit segment; 131, "U"-shaped structure; 14, barb; 15, connecting ear; 20, sealing membrane; 30, flap Leaf; 40, developing parts; 50, avoiding the gap.

detailed description

Preferred embodiments according to the present invention will be described in detail below with reference to the accompanying drawings. It is to be pointed out that this description is for purposes of illustration only and not limitation, and those skilled in the art will understand that the invention may be practiced in various ways and should not be limited to the preferred embodiments described herein.

As used in this invention, the use of "one embodiment" or "the embodiment" does not mean that a feature described in an embodiment of the invention is only applicable to that embodiment, but rather one embodiment The features of the present invention may also be used in other embodiments or combined with features of other embodiments to obtain yet another embodiment, all of which are intended to fall within the scope of the present invention.

In the following description and the appended claims, the directional terms "proximal," "proximal," or "distal," "distal," etc. are used, with the understanding that proximal or proximal Refers to the direction near or close to the operator, eg, a doctor, nurse, or other medical personnel, while distal or distal refers to the direction away from the proximal or proximal end or the direction close to the patient or prosthesis implanter. Additionally, in the following description and the appended claims, the directional terms "upstream" and "downstream" are used, where "upstream" refers to the direction from which the fluid originates and "downstream" refers to the fluid direction of flow. In addition, it should be pointed out that all directional terms are used for the convenience of description and do not limit the protection scope of the present disclosure. In addition, in the following description and claims, dimension terms such as "diameter" and "radius" are used. It should be understood that the terms are not only used to indicate the size of a circular shape. It can represent the diameter of the approximately shaped circle or the largest dimension in that dimension.

In the following description, ordinal numbers such as first and second are also used, but it should be understood that the use of these ordinal numbers is only for the meaning of distinguishing one feature from another, rather than implying a certain feature The importance or necessity of modifying a feature with a "first" may also be referred to as a "second" without changing the scope of the present disclosure. The present invention will be described in detail below with reference to the accompanying drawings and in conjunction with the embodiments.

1-6 depict a prosthetic valve according to one embodiment of the present disclosure. As shown in FIG. 1 to FIG. 6 , the artificial valve of this embodiment includes: a stent 10 and a valve leaflet 30 . The bracket 10 includes a first grid segment 11, a second grid segment 12 and a limiting segment 13 which are connected in the axial direction X, the second grid segment 12 is located between the first grid segment 11 and the limiting segment 13, and the second grid segment 12 is located between the first grid segment 11 and the limiting segment 13. 12 is surrounded by a barrel-shaped structure, the diameter of the first grid segment 11 increases from the direction close to the second grid segment 12 to the direction away from the second grid segment 12, and the first grid segment 11 is irregular in shape, preferably, formed with avoidance Gap, the limiting segment 13 has outward flanges. The leaflets 30 are arranged on the second mesh segment 12 so that the flow direction of the fluid is from the first mesh segment 11 to the limiting segment 13 .

In one embodiment, the stent 10 is formed by a laser using a nickel-titanium tube, and the first mesh segment 11 , the second mesh segment 12 and the limiting segment 13 are integrally formed. However, the present disclosure is not limited to this, but the first The one mesh segment, the second mesh segment, and the stop segment may be formed separately and joined together, eg, by laser welding, gluing, or the like.

The size of the stent 10 is determined according to the size of the anatomical structure of the body part to be implanted. As an example, the maximum dimension D1 of the cross-section of the first mesh segment 11 is in the range of 40-70 mm, and the cross-section of the second mesh segment is the largest The dimension D2 is in the range of 20-50mm, and the maximum dimension D3 of the cross-section of the limiting section is in the range of 25-60mm. And the entire height H1 of the stent 10 is in the range of 20-40 mm, and the height H2 of the second grid segment is in the range of 10-20 mm, so as not to hinder the normal opening and closing of the valve leaflets.

In one embodiment, a sealing membrane 20 is provided on the first mesh segment 11 and/or the second mesh segment 12 to prevent paravalvular leakage when the prosthetic valve is implanted into the human body. The sealing membrane 20 may be formed using materials derived from animals such as bovine pericardium, porcine pericardium, etc., but the present disclosure is not limited thereto, and other suitable biocompatible synthetic materials may be used. The sealing film 20 may be sutured to the first mesh segment 11 and the second mesh segment 12 by stitches, however, the present disclosure is not limited thereto, and other methods that can be conceived by those skilled in the art can be adopted, for example, Welding, bonding, rivets, etc.

As shown in FIG. 1 and FIG. 4 , in the technical solution of this embodiment, the limiting segment 13 is connected to the second grid segment 12 , and the limiting segment 13 includes at least one inverted “U”-shaped structure 131 . The vertex of the structure 131 extends toward the direction of the first mesh segment 11 . Preferably, the limiting segment 13 includes a ring surrounded by a plurality of inverted U-shaped structures 131 , and the position between the two U-shaped structures of the ring is connected to the second mesh segment 12 through a connecting rod (not marked), and the U The diameter size of the ring enclosed by the type structure is larger than the size of the second mesh segment 12 , so that the limiting segment 13 constitutes the flange of the second mesh segment 12 . The "U"-shaped structure 131 is easy to set and process, and the "U"-shaped structure 131 is a smooth transition, so that it will not cause damage to the organs of the body. The bending part of the "U"-shaped structure 131 is an arc-shaped transition, which not only ensures that the stress of the stent 10 will not be concentrated, nor will it damage the organs and tissues of the body. It should be noted that the artificial valve of this embodiment can be used to replace the mitral valve or the tricuspid valve of the human body. However, the present disclosure is not limited thereto, and the limiting segment 13 may also include a "V"-shaped structure, or a wave-shaped structure.

As shown in FIGS. 1 and 4 , in the technical solution of the present embodiment, the limiting section may pass through the connecting rod at both ends of the “U”-shaped structure or at approximately the middle position between two adjacent U-shaped structures (not identified) are respectively connected to the second grid segments 12 . The above structure is compact and easy to use. Specifically, the limiting segment 13 , the second grid segment 12 and the first grid segment 11 can be laser cut by a pipe material, so that the connection between the first grid segment 11 , the second grid segment 12 and the limiting segment 13 has a smooth transition. The same product can also be made by wire weaving.

As shown in FIGS. 1 and 4 , the limiting segment 13 includes a plurality of “U”-shaped structures, and the multiple “U”-shaped structures are preferably evenly distributed around the circumferential direction of the second mesh segment 12 . This ensures that the artificial valve is relatively balanced when it interacts with the body tissue. As an optional example, multiple "U"-shaped structures can be arranged at intervals, or the ends of adjacent "U"-shaped structures can be connected at the same connection point, so that multiple "U"-shaped structures are composed of The limiting section 13 is a wavy structure. As an example, the limiting segment includes three "U"-shaped structures, three leaflets 30, and the three leaflets 30 are arranged in a one-to-one correspondence with the three "U"-shaped structures, that is, when viewed in the axial direction , each of which includes a U-shaped structure in the sectors covered by the three leaflets 30 . The above structure further ensures that the installation of the artificial valve is relatively stable. Taking the tricuspid valve as an example, the three "U"-shaped structures can contact the valve leaflets or myocardial tissue for positioning and fixation; then the second grid and the first grid are released, and the valve is stuck at the tricuspid valve. When the ventricle dilates, the blood flows from the right atrium through the artificial valve into the right ventricle; when the heart contracts, the blood pressure closes the artificial valve, giving the valve pressure to the atrium, and the three "U"-shaped structures interact with the tissue to provide a reaction force to fix the valve. in the tricuspid valve position.

As shown in FIG. 1 to FIG. 6 , the first mesh segment 11 is a bell-shaped structure. The first mesh segment 11 is a bell-shaped structure, on the one hand, it ensures that the first mesh segment 11 forms a limit to another angle of the artificial valve, that is, the artificial valve will not fall into the ventricle from the installation position, and on the other hand, due to the first mesh A sealing membrane 20 is installed on the grid segment 11 and/or the second grid segment. As shown in FIG. 7 , when the first grid segment 11 and the second grid segment 12 fit with the body tissue, paravalvular leakage can be avoided. The first grid segment 11 is composed of two, three or multiples of three petal-shaped support bars, and the support bars are evenly arranged in the circumferential direction. In one embodiment, the first mesh segment 11 is provided with an avoidance gap, and the avoidance gap is a fan-shaped structure. As an example, the avoidance gap can be formed by a petal-shaped support bar without a coating, so that the avoidance gap has connecting ribs, and the connecting ribs are connected to the support bars on both sides of the avoidance gap. However, the present disclosure is not limited to this, and the avoidance gap may not be provided with connecting ribs, as shown in FIG. 3 .

As shown in FIG. 1 , the bracket 10 further includes a plurality of connecting ears 15 , and the plurality of connecting ears 15 are arranged on the first end of the first mesh segment 11 . The provision of the connecting ears 15 facilitates the connection of the prosthetic valve to the delivery device. The connecting ears 15 may be provided with connecting holes. One end of the first grid segment 11 with a smaller diameter is connected to the second grid segment 12 .

As shown in FIGS. 1 to 6 , the second mesh segment 12 is substantially barrel-shaped, which need not have a circular cross-section, and its size and cross-sectional shape can be determined according to the site to be implanted. As shown in Figures 1 and 4, the second mesh segment 12 comprises two rings connected to each other in the axial direction (the height direction of the pages of Figures 1 and 4), wherein each ring comprises a plurality of wave shapes, the waves of the first ring The wave crests of the shape are connected with the wave troughs of the second ring through connecting rods, and each wave shape is formed into a zigzag shape. However, the present disclosure is not limited to this, and each wave shape can also be formed with a rounded transition. U-shaped or otherwise. In the present disclosure, as shown in FIGS. 1 to 5 , the second mesh segment 12 includes two wavy rings, however, the present disclosure is not limited thereto, and may also include one or more rings.

As shown in FIGS. 1 to 3, the leaflets 30 are connected in the second mesh segment 12, and in the embodiment shown in FIG. 1, three leaflets 30 are included, however, the present disclosure is not so limited, and Implantation site and other factors, two leaflets or four leaflets, or even more leaflets 30 may be employed. The leaflets 30 are formed from animal derived materials such as porcine pericardium, bovine pericardium, however, the present disclosure is not so limited and other biocompatible synthetic materials may be employed.

The leaflets 30 may be sutured to the sealing membrane 20 and the second mesh segment 12 using sutures (not shown), as shown by the thick solid lines in FIG. 1 , but the present disclosure is not so limited, and adhesives may be used , welding, rivets and other methods. As shown in FIG. 1, the leaflet 30 includes arcuate edges sutured to the second mesh segment 12 and the sealing membrane 20, and includes a free edge. When the leaflet 30 is implanted in place, as shown in FIG. 7, in the blood flow When the direction is from the first grid segment toward the limit segment, the free edge of each leaflet 30 is pushed apart, allowing blood to flow through, and when the blood flow in the opposite direction passes, blood fills each leaflet 30, Thereby, the free edge portions of the three leaflets are abutted and closed.

In the embodiment shown in FIGS. 1 and 4 , the stent 10 further includes barbs 14 connected to the second mesh segment 12 and extending in a direction away from the central axis of the second mesh segment 12 , pointing toward the first mesh segment 12 . Orientation of the grid. The second mesh segment 12 is provided with barbs 14, which can penetrate into the tissue around the native valve for fixing. In the technical solution of this embodiment, the angle between the barbs 14 and the central axis of the second grid segment 12 is 10 degrees to 80 degrees, preferably 60 degrees. The length of the barbs 14 is between 1 mm and 10 mm.

As shown in FIG. 1 , in the technical solution of this embodiment, there are multiple barbs 14 . The structure of the multiple barbs 14 makes the artificial valve and the body tissue more focal points, and the fixation of the artificial valve is more stable. Specifically, the number of barbs 14 is three groups or a multiple of three groups.

As shown in FIGS. 1 and 4 , the length of the barbs 14 is 1 mm to 10 mm. Preferably, the length of the barbs 14 is 3 mm. When the above-mentioned barbs 14 fix the artificial valve, they will not stab other organs due to being too long, nor will they be too short to cause unstable fixation.

In the embodiments shown in FIGS. 1 and 6 , the artificial valve further includes a developing member 40 , and the developing member 40 is arranged on the limiting section 13 of the stent 10 . The provision of the developing member 40 facilitates circumferential positioning. The developing member 40 can be a metal with good developability, such as platinum, gold or platinum-iridium alloy. After the artificial valve enters the body, with the aid of the developing device, the developing component 40 can be clearly displayed on the screen of the device, which helps the valve to be clearly positioned.

As shown in FIG. 6 , in the technical solution of this embodiment, the developing member 40 is located at the distal apex of the “U”-shaped structure of the limiting segment, and at least one of the “U”-shaped structures has a developing member. The developing member 40 may be at a plurality of vertices of the "U"-shaped structure, but the developing member on at least one vertex is different from other vertexes, and can distinguish the circumferential direction of the prosthetic valve. Valve positioning is more accurate when multiple "U"-shaped structures have developing points. In FIG. 6 , there are developing components 40 at three or more “U”-shaped structure vertices, and each vertex has a different number of developing components, 1, 2, and 3, respectively, and the vertices can be distinguished from each other. When the sheath tube is released from the distal end of the valve, the circumferential position of the valve can be confirmed according to different developing components. By rotating the delivery system, the "D"-shaped structure valve corresponds to the "D"-shaped anatomical structure of the human body. fully released.

The implantation method of the artificial valve according to the present disclosure will be described below with reference to FIGS. 7 to 9 . It should be noted that in the following description, the artificial valve is formed by using a memory alloy to automatically restore the set shape when released as an example. description, but the present disclosure is not limited thereto, and the valve can also be opened by means of a balloon or the like.

As shown in FIG. 8, the delivery device 100 includes a handle 110 and a catheter 120, the distal portion of the catheter 120 includes a receiving space in which the compressed prosthetic valve is placed, and the catheter 120 includes an outer tube and an inner tube, which are manipulated by The handle 110 can move the outer tube relative to the inner tube to release the prosthetic valve.

During implantation, the artificial valve is firstly reduced in diameter to a size that can be accommodated in the accommodating space, and the connecting ears of the first mesh segment are connected with the corresponding connecting mechanism on the inner tube of the delivery device, and the outer tube is moved to reduce the diameter The prosthetic valve is enclosed in the containment space. The prosthetic valve is delivered to the target location, for example, the right ventricle, through the delivery device, first by manipulating the handle, such as turning the handle, to move the outer tube proximally relative to the inner tube, thereby releasing the limiting segment, as shown in Figure 9, According to the development point of the apex of the limiting segment, the conveyor is rotated as a whole to adjust the circumferential direction of the artificial valve, so that the "D"-shaped structure after the valve is released can correspond to the "D"-shaped annulus of the tricuspid valve. At this time, when the entire delivery device is withdrawn proximally, and the artificial valve is withdrawn, the inverted U-shaped structure of the limiting segment 13 will be in contact with the native valve leaflet 20 or the chordae tendineae to form a blocking limit. Manipulation of the handle of the delivery device is then continued to release the second mesh segment, which has an increased diameter jamming the tricuspid annulus and, where present, the barbs 14 piercing into the surrounding musculature. Finally, the first mesh segment is released, and the diameter of the first mesh segment increases from the direction close to the second mesh segment to the direction away from the second mesh segment, so that the first mesh segment will form a limit in the other direction to prevent the valve from falling into the right ventricle , at this time, the whole prosthetic valve is implanted, as shown in Figure 7.

The above structure enables the artificial valve to have a better fixation effect at the tricuspid valve. The technical scheme of the present invention effectively solves the problems of the adaptability and circumferential positioning of the artificial valve and human organs. The avoidance gap can avoid the location of the coronary sinus ostium, and also ensure that the atrioventricular node is not compressed, and the blood flow from the coronary sinus will not be blocked to the right atrium. The first mesh segment 11 may be of regular shape, such as mesh, or may be of irregular shape. Also, the first mesh segment 11 has an escape gap. The avoidance gap can effectively avoid the coronary venous orifice, and the developing member 40 is arranged corresponding to the valve leaflet, so that the position of the developing member 40 can determine whether the position of the valve leaflet is properly placed.

As shown in FIG. 6 , as another embodiment, the cross-section of the second mesh segment 12 is “D”-shaped, including a D-shaped straight segment and an arc-shaped segment. When viewed along the axial direction, the first mesh The avoidance gap of the grid segment is set at the connection between the straight segment and the arc segment of the "D" shape. The above structure is better adapted to the structure of human organs.

In one embodiment, the valve is "D" shaped, and the three valve leaflets 30 do not have to be exactly the same, and the shape of the valve leaflet on the straight side is different from the shape of the valve leaflet on the curved side.

By arranging the barbs 14 on the outer side wall of the stent 10, especially on the second mesh segment, when the heart valve (artificial valve) is released to the target position, it can penetrate into the tissue around the valve, thereby enhancing the fixation. effect. After the heart valve is released, the barbs 14 penetrate into the valve annulus of the human body, and are not easily displaced.

In addition, in this embodiment, the developing member may be provided only on the vertex corresponding to the D-shaped straight segment leading to the U-shaped structure, whereby the circumferential positioning of the prosthetic valve can be determined by the developing member during implantation .

The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

An artificial valve comprising:

A bracket (10), the bracket (10) comprising a first mesh segment (11), a second mesh segment (12) and a limit segment (13) connected in sequence in the axial direction, the second mesh segment ( 12) Located between the first grid segment (11) and the limiting segment (13), the second grid segment (12) encloses a barrel-like structure, and the first grid segment (11) is formed by a The diameter of the second mesh segment (12) to a direction away from the second mesh segment (12) increases, and the limiting segment (13) has an outward flange;

At least two leaflets (30), the at least two leaflets (30) are arranged on the inner circumference of the second mesh segment (12), and are arranged so that when the flow direction of the fluid is the first direction, at least two The leaflets are spaced apart from each other to allow fluid flow therethrough, and when the direction of fluid flow is the second direction, at least two leaflets are closed to prevent fluid flow therethrough.
The prosthetic valve of claim 1, further comprising a sealing membrane disposed on at least one of the first mesh segment and the second mesh segment.
The prosthetic valve according to claim 1 or 2, wherein the limiting segment (13) comprises at least one ring surrounded by an inverted "U"-shaped structure, the diameter of the ring being larger than the diameter of the second mesh segment A flanged form of the second mesh segment is formed, and the limiting segment (13) is connected to the second grid segment (13) at the junction between two adjacent inverted U-shaped structures or at the end of the inverted U-shaped structure through a connecting rod. The grid segments (12) are connected.
The prosthetic valve according to claim 3, wherein the limiting segment (13) comprises a plurality of "U"-shaped structures surrounding the distal end of the second mesh segment (12) The ends are evenly distributed.
The prosthetic valve according to claim 3, wherein there are three "U"-shaped structures and three leaflets (30).
6. The prosthetic valve of claim 5, wherein, when viewed in the axial direction, a U-shaped structure is included within the sector in which each leaflet is located.
The prosthetic valve according to any one of claims 1 to 6, wherein the first mesh segment (11) is a bell mouth structure, and the first mesh segment (11) is composed of two, three or Multiples of three are composed of petal-shaped support bars, and the support bars are evenly arranged in the circumferential direction.
The prosthetic valve according to claim 7, wherein the first mesh segment (11) is formed with an escape gap and is a fan-shaped structure.
The prosthetic valve according to claim 8, wherein the escape gap is formed by not laying a sealing membrane or partially including a support bar.
The prosthetic valve according to any one of claims 1 to 9, wherein the stent (10) further comprises a plurality of connecting ears (15), and the plurality of connecting ears (15) are arranged on the first mesh The end of the grid segment (11) furthest away from the second grid segment.
The artificial valve according to any one of claims 1 to 10, wherein the stent (10) is made by a cutting process or a weaving process.
The prosthetic valve according to any one of claims 1 to 11, wherein the stent (10) further comprises barbs (14) provided on the second mesh segment (12) on the outer circumference and extending obliquely in a direction away from the central axis of the second grid segment (12) and towards the first grid segment.
The prosthetic valve according to claim 12, wherein the barbs (14) are plural, and the angle between the barbs (14) and the outer sidewall of the second mesh segment (12) is 10 degrees Between ～80 degrees, the length of the barb is 1mm～10mm.
The prosthetic valve according to any one of claims 1 to 13, wherein the prosthetic valve further comprises a developing member, and the developing member is provided on the stent (10).
The prosthetic valve according to claim 14, wherein the developing member is located at the vertex of the inverted U-shaped structure of the limiting section (13), and the developing member on at least one vertex is different from other vertexes.
The prosthetic valve according to any one of claims 1 to 15, wherein the cross section of the second mesh segment (12) is "D"-shaped, including a D-shaped straight segment and a D-shaped arcuate segment.
The prosthetic valve according to claim 16, wherein the avoidance notch is arranged on the first grid segment at a position corresponding to the junction of the "D"-shaped straight segment and the arcuate segment.
The prosthetic valve according to claim 16, wherein the limiting segment (13) is provided with a developing point only on the vertex of the inverted U-shaped structure corresponding to the "D"-shaped straight segment of the second grid segment.
A method of implanting a prosthetic valve, comprising:

preparing a prosthetic valve as claimed in any one of claims 1 to 18;

retracting the prosthetic valve within the receiving chamber of the distal end of the delivery device;

delivering the prosthetic valve by the delivery device to the target implantation site; and

Release the prosthetic valve.
The implantation method of claim 19, wherein releasing the prosthetic valve comprises:

Release the limiting segment of the prosthetic valve;

Adjust the circumferential positioning of the artificial valve according to the development point of the limit segment;

releasing the second mesh segment of the prosthetic valve; and

Release the first mesh segment of the prosthetic valve.
The implantation method of claim 19 or 20, before releasing the second mesh segment of the prosthetic valve, further comprising moving the delivery device proximally to retract the limiting segment to catch the native valve leaflets or chordae tendineae.
21. The implantation method of any one of claims 19 to 21, wherein releasing the first mesh segment of the prosthetic valve includes aligning the escape notch with the predetermined tissue.
22. The implantation method of any one of claims 19 to 22, wherein releasing the second mesh segment of the prosthetic valve comprises penetrating the barbs into surrounding tissue.