Valve prosthesis

Abstract

Provided is a valve prosthesis (200), comprising an inflow end (242) and an outflow end (241). The valve prosthesis (200) comprises a stent (210), a sealing member (220), and a covering membrane (260). The covering membrane (260) covers at least a portion of the stent close to the inflow end. The sealing member (220) comprises a sealing material (2201), a first fixing member (2202), and a second fixing member (2203). The sealing material (2201) comprises a first edge (2201a) and a second edge (2201b) that are arranged opposite. The first edge (2201a) or a region near the first edge is fixed to the covering membrane (260) by the first fixing member (2202), then the second edge (2201b) is rolled or folded to approach the first edge (2201a) to form an annular structure (2201c) arranged on the outer side of the covering membrane (260), and then the annular structure (2201c) is fixed to the covering membrane (260) by the second fixing member (2203). Therefore, a sealing member that is accurately positioned on the valve prosthesis stent and shaped can be obtained, with reduced potential of paravalvular leakage.

Description

Valve prosthesis TECHNICAL FIELD

[0001] The present application relates to the technical field of interventional medical devices, in particular to a valve prosthesis. BACKGROUND

[0002] The background provided in this section is merely for the purpose of enhancing the understanding of the present disclosure and does not necessarily describe the prior art.

[0003] When a native heart valve narrows, or a native valve leaks or regurgitates (e.g., due to calcification of the valve leaflets), a heart valve replacement can be performed. In one treatment regimen, the native valve can be excised and replaced with a bioprosthetic valve or a mechanical valve. To avoid paravalvular leakage of the bioprosthetic valve or the mechanical valve in the body, the outer surface of the bioprosthetic valve or the mechanical valve is provided with a sealing ring, which can seal the gap between the bioprosthetic valve or the mechanical valve and the annulus to prevent blood leakage. However, the sealing ring has a certain thickness and is not easy to accurately position at a specific position of the bioprosthetic valve or the mechanical valve. SUMMARY

[0004] Therefore, it is necessary to provide a valve prosthesis, which comprises a stent, a sealing member and a covering film, the covering film at least covers a part of the stent close to the inflow end, the sealing member comprises a piece of sealing material, a first fixing member and a second fixing member, the sealing material comprises a first edge and a second edge arranged oppositely, the first edge or a region near the first edge is fixed to one edge of the covering film close to the outflow end by the first fixing member, then the second edge is brought close to the first edge by rolling or folding to form a ring structure arranged outside the covering film, and the ring structure is fixed to the covering film by the second fixing member.

[0005] Compared with the prior art, the valve prosthesis has the following beneficial effects:

[0006] The valve prosthesis comprises the sealing member including the sealing material, the first fixing member and the second fixing member, the first edge or the region near the first edge is fixed to one edge of the covering film close to the outflow end by the first fixing member to achieve preliminary positioning, then the second edge is brought close to the first edge by rolling or folding to form a ring structure arranged outside the covering film, in this process, there is a relatively flexible adjustment space, so that the sealing member can be accurately positioned on the stent, and the sealing member can also be accurately shaped, finally, the ring structure is fixed to the covering film by the second fixing member to achieve final fixation, so that the sealing member is accurately positioned and shaped on the valve prosthesis stent, and the valve prosthesis can better adapt to the physiological environment in the body to greatly reduce the occurrence of paravalvular leakage. BRIEF DESCRIPTION OF DRAWINGS

[0007] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the accompanying drawings needed to be used in the embodiments or prior art description will be briefly introduced as follows. Obviously, the accompanying drawings in the following description only represent some embodiments of the present application, and for those skilled in the art, other drawings can be obtained based on these drawings without any creative effort.

[0008] Fig. 1 is a structural schematic view of a valve prosthesis in an embodiment of the present application;

[0009] Fig. 2 is a structural schematic view of the cooperation between a stent and an expanded sealing material and an expanded covering in an embodiment of the present application;

[0010] Fig. 3 is a structural schematic view of an expanded sealing material in an embodiment of the present application;

[0011] Fig. 4 is a structural schematic view of the cooperation between a stent and a rolled sealing material and an expanded covering in an embodiment of the present application;

[0012] Fig. 5 is a structural schematic view of a rolled sealing material in an embodiment of the present application;

[0013] Fig. 6 is an enlarged schematic view of the structure at A in Fig. 1;

[0014] Fig. 7 is a structural schematic view of a stent in an embodiment of the present application;

[0015] Fig. 8 is a structural schematic view of a covering in an embodiment of the present application;

[0016] Fig. 9 is a structural schematic view of an expanded structure of a covering in an embodiment of the present application;

[0017] Fig. 10 is a structural schematic view of a valve prosthesis in a closed state in an embodiment of the present application;

[0018] Fig. 11 is a structural schematic view of a valve prosthesis in an open state in an embodiment of the present application;

[0019] Fig. 12 is a schematic view of a suture rod before and after deformation in an embodiment of the present application;

[0020] Fig. 13 is a schematic view of the connection between a suture rod and an inflow end portion and an outflow end portion in an embodiment of the present application;

[0021] Fig. 14 is a structural schematic view of a valve prosthesis in an embodiment of the present application. DETAILED DESCRIPTION

[0022] In order to make the above objectives, features and advantages of the present application more clear and comprehensible, specific embodiments of the present application are described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be practiced in a variety of ways beyond the specific embodiments described herein without departing from the scope of the present application, and it is understood that similar improvements can be made by those skilled in the art without departing from the spirit of the present application. Therefore, the present application is not limited by the specific implementation disclosed below.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0024] In the field of interventional medical devices, the term "distal" end is commonly defined as the end of the device that is further from the operator during a procedure, and the term "proximal" end is commonly defined as the end of the device that is closer to the operator during a procedure. A valve prosthesis generally includes an open state and a closed state, in which blood flow can pass through the valve prosthesis and in which blood flow is blocked by the valve prosthesis, respectively. In the open state of the valve prosthesis, referring to FIG. 1, the end of the valve prosthesis through which blood flow enters is defined as the inflow end 242, and the end of the valve prosthesis through which blood flow exits is defined as the outflow end 241.

[0025] The present embodiment provides a valve prosthesis 200 for use in an interventional valve or a surgical valve at a valve position of an aortic valve, a mitral valve, a tricuspid valve, or a pulmonary valve, etc., to replace a native valve to achieve heart valve replacement. As shown in FIG. 1, the valve prosthesis 200 includes a stent 210, a sealing member 220, and a covering 260, and the covering 260 at least covers a portion of the stent 210 close to the inflow end 242.

[0026] Referring to FIGS. 2-6, the sealing member 220 includes a sealing material 2201, a first fixing member 2202, and a second fixing member 2203. The sealing material 2201 includes a first edge 2201a and a second edge 2201b arranged oppositely. The first edge 2201a or a region near the first edge 2201a is fixed to the covering 260 by the first fixing member 2202, and then the second edge 2201b is brought close to the first edge 2201a by rolling or folding to form a ring structure 2201c arranged outside the covering 260, and the ring structure 2201c is fixed to the covering 260 by the second fixing member 2203.

[0027] In an embodiment, the ring structure 2201c can be understood as a closed loop structure, or can be an open loop structure. In an embodiment, the ring structure 2201c can also be a closed loop structure or an open loop structure formed by splicing of multiple segment structures.

[0028] The valve prosthesis 200 includes a sealing member 220 by setting a sealing member 220 including a sealing material 2201, a first fixing member 2202 and a second fixing member 2203, a first edge 2201a or a nearby area of the first edge 2201a is fixed with the covering membrane 260 by the first fixing member 2202 to achieve preliminary positioning; then the second edge 2201b is close to the first edge 2201a by rolling or folding to form a ring structure 2201c arranged outside the covering membrane 260, which has a relatively flexible adjustment space in the process, so that the sealing member 220 can be accurately positioned on the stent 210, and the sealing member 220 can also be accurately shaped; finally, the ring structure 2201c is fixed with the covering membrane 260 by the second fixing member 2203 to achieve the final fixation, so that the sealing member 220 accurately positioned and shaped on the valve prosthesis stent 210 is obtained, which can better adapt to the physiological environment in the body to greatly reduce the occurrence of paravalvular leakage.

[0029] It can be understood that in the actual valve prosthesis preparation process, after the ring structure 2201c is fixed with the covering membrane 260 by the second fixing member 2203 to form the sealing member 220 of the valve prosthesis, it is found that the shape and position of the sealing member 220 formed need to be adjusted again. Generally, the solution is to separate the entire sealing member 220 from the stent 210, then adjust the shape of the ring structure 2201c alone, and finally position the ring structure 2201c on the stent 210. This method is complicated on the one hand, and there is a relatively large error in the positioning and shaping of the sealing member 220 on the other hand. The second fixing member 2203 can be removed (for example, cut off) in the embodiment, the second edge 2201b is unfolded and exposed, the second edge 2201b is close to the first edge 2201b by rolling or folding to form a ring structure 2201c arranged outside the covering membrane in a suitable shape and position, and the ring structure 2201c is fixed with the covering membrane 260 by the second fixing member 2203. Therefore, the shape and position of the sealing member 220 can be adjusted at any time by the sealing member 220 of the embodiment, and the sealing member 220 accurately positioned and shaped on the valve prosthesis stent 210 is obtained.

[0030] In an embodiment, when the first edge 2201a is fixed to the covering membrane 260 by the first fixing member 2202, a first protruding portion 2201a1 facing the outflow end 241 direction is formed, along the first protruding portion 2201a1, the second edge 2201b is close to the first edge 2201a by rolling or folding, so that the ring structure 2201c formed has a filling portion 222 protruding towards the outflow end 242 direction.

[0031] In the anatomical structure, in order to prevent the damage to the blood vessels, the native leaflets at the native commissure are not completely cut off, so that some residual hardened tissues are left, and the two adjacent native commissures have a protrusion towards the outflow end. In the protrusion position, during the process of closing the leaflets, the blood flow from the outflow end side of the valve prosthesis flows back into the protrusion position, so that the blood flow is retained in the protrusion position to form a thrombus.

[0032] Referring to FIGS. 4 and 5, the sealing material 2201 can be made of one or more materials such as bovine pericardium, porcine pericardium, silicone, or rubber. The annular structure 2201c has a certain elastic deformation performance. After implantation of the annulus, the outer wall of the annular structure 2201c is in close contact with the native annulus tissue, and the inner wall of the annular structure 2201c is in close contact with the outer wall of the stent 210. The annular structure 2201c is used to block the gap between the stent 210 and the native annulus tissue. The annular structure 2201c further includes a sealing portion 221, and a filling portion 222 is connected to the sealing portion 221, and the filling portion 222 is located on the side of the sealing portion 221 close to the outflow end. In this embodiment, the sealing portion 221 as a whole has a curved shape towards the inflow end, which is used to better fit the native annulus. Alternatively, referring to FIG. 1, the sealing portion 221 as a whole can also have a straight shape.

[0033] After the valve prosthesis 200 is implanted in the position corresponding to the native annulus, the annular structure 2201c is arranged around the outer wall of the stent 210, so that the annular structure 2201c can fill the gap between the stent 210 and the native annulus, and the filling portion 222 protrudes towards the outflow end direction, so that the filling portion 222 can extend into the protrusion position between the commissures after implantation, so as to squeeze out the blood in the protrusion position and prevent the blood from being retained in the protrusion position to form a thrombus.

[0034] Referring to FIGS. 2-5, in an embodiment, the first edge 2201a includes a first protrusion 2201a towards the outflow end direction, and the second edge 2201b is arranged parallel to the first edge 2201a. It can be understood that when the first protrusion 2201a is arranged on the first edge 2201a, the first protrusion 2201a only needs to be connected to a suitable position on the stent 210, and then the sealing material 2201 is directly wrapped around the stent 210. Moreover, arranging the second edge 2201b parallel to the first edge 2201a can form a ring structure 2201c with a uniform diameter after the second edge 2201b is close to the first edge 2201a by rolling or folding, so that the outer edge of the sealing portion 221 and the outer edge of the filling portion 222 are located on the same circumferential plane, thereby increasing the stability of the abutment between the sealing member 220 and the native annulus. In other embodiments, the first protrusion 2201a is not directly arranged on the first edge 2201a, but is formed by fixing the first edge 2201a to the covering film 260 by the first fixing member 2202.

[0035] Referring to FIGS. 2 and 6, in the present embodiment, the first fixing member 2202 can be a first suture 2202a, and the first suture 2202a is arranged by being sewn along an edge of the covering film 260. The second fixing member 2203 includes a second suture 2203a, and the second suture 2203a includes a plurality of loop lines 2203a1, and the plurality of loop lines 2203a1 are wound around the surface of the ring structure 2201c to achieve the fixation of the ring structure 2201c. In other embodiments, the first fixing member 2202 and the second fixing member 2203 can also be glue or welding material, etc., and at least one edge of the ring structure 2201c close to the inflow end 242 overlaps with the covering film 260, so that the ring structure 2201c and the covering film 260 are closely attached without gaps, which can better block the leakage of backflow blood and cause paravalvular leakage.

[0036] As shown in FIG. 7, the stent 210 is adapted to be implanted at the annulus of the human body, the diameter of the stent 210 is larger than the diameter of the annulus of the human body, and the stent 210 has a certain elastic deformation performance to fit with the annulus of the human body. The stent 210 includes an outflow end 211, an inflow end 213, and a main body 212, the main body 212 is located between the outflow end 211 and the inflow end 213, and the two axial ends of the main body 212 are connected with the outflow end 211 and the main body 212 respectively. The outflow end 211 includes a first wave-shaped ring 2111 and a second wave-shaped ring 2112, the first wave-shaped ring 2111 and the second wave-shaped ring 2112 are spaced apart along the axial direction of the stent 210, and the first wave-shaped ring 2111 and the second wave-shaped ring 2112 are connected by a plurality of rod-shaped members, and the plurality of rod-shaped members are spaced apart along the circumferential direction of the stent 210. The inflow end 213 includes a third wave-shaped ring 2131 and a fourth wave-shaped ring 2132, the third wave-shaped ring 2131 and the fourth wave-shaped ring 2132 are spaced apart along the axial direction of the stent 210, and the third wave-shaped ring 2131 and the fourth wave-shaped ring 2132 are connected by a plurality of rod-shaped members, and the plurality of rod-shaped members are spaced apart along the circumferential direction of the stent 210. The main body 212 includes a plurality of suture rods 2121, and the plurality of suture rods 2121 are spaced apart along the circumferential direction of the stent 210.

[0037] The leaflet assembly 230 is connected with the inner wall of the main body 212, the leaflet assembly 230 is sutured on the suture rod 2121, and the leaflet assembly 230 includes an open state and a closed state. When the leaflet assembly 230 is in the open state, blood flow can pass through the inside of the main body 212. When the leaflet assembly 230 is in the closed state, blood flow is hindered by the leaflet assembly 230 and cannot pass through the inside of the main body 212.

[0038] In combination with FIGS. 1, 8 and 9, the covering 260 includes an outer covering 2601 and an inner covering 2602 connected with each other, the inner covering 2602 is arranged on the inner wall of the stent 210 and connected with the leaflet assembly 230, and the outer covering 2601 is arranged on the outer wall of the stent 210. Among them, one side of the outer covering 2601 close to the outflow end 241 includes a second protruding portion 2601a facing the direction of the outflow end 241, and the second protruding portion 2601a is fixed together with the first protruding portion 2601a through the first fixing member 2202, so that the second protruding portion 2601a is axially spaced apart from the filling portion 222. In this way, on the one hand, the length of the outer covering 2601 is increased, the sealing performance is better, and the possibility of paravalvular leakage is reduced, on the other hand, the protruding position between the original leaflet fusion tissues can be completely filled with the second protruding portion 2601a of the outer covering 2601 and the filling portion 222 without gap, thereby avoiding the accumulation of blood in the protruding position between the original leaflet fusion tissues during the closing process of the leaflet assembly 230 after the blood backflow, and avoiding the formation of thrombus.

[0039] As shown in FIG. 1, the stent 210 includes a plurality of suture rods 2121 arranged along the axial direction of the stent 210, and the plurality of suture rods 2121 are arranged along the circumferential direction of the stent 210. The leaflet assembly 230 is located on the inner side of the stent 210 and connected with the suture rods 2121. The filling portion 222 is connected with the suture rods 2121.

[0040] The two ends of the suture rods 2121 are connected with the outflow end 211 and the inflow end 213 of the stent 210, respectively. The suture rods 2121 are arranged along the axial direction of the stent 210. There are a plurality of suture rods 2121, and the plurality of suture rods 2121 are arranged along the circumferential direction of the stent 210. The plurality of suture rods 2121 enclose the main body portion 212. The leaflet assembly 230 is located on the inner side of the main body portion 212 and connected with the side wall of the suture rods 2121.

[0041] As shown in FIG. 10, in the process of switching the leaflet assembly 230 from the closed state to the open state, the heart is in the systolic state, the free end of the leaflet 2301 is moved towards the direction away from the center of the main body portion 212 under the pressure of the heart chamber, the leaflet 2301 pulls the suture rod 2121 to move towards the direction away from the center of the stent 210, the suture rod 2121 is tilted towards the direction away from the center of the stent 210 under the pulling action of the leaflet 2301 to reset, the suture rod 2121 is not pulled by the leaflet 2301 after resetting, the filling portion 222 is reset following the movement of the suture rod 2121, the included angle between the suture rod 2121 and the axis of the stent 210 is a1, and the vertical distance between the filling portion 222 and the inflow end of the stent 210 is d1.

[0042] As shown in FIG. 11, in the process of switching the leaflet assembly 230 from the open state to the closed state, the heart is in the diastolic state, the free end of the leaflet 2301 is moved towards the direction close to the center of the main body portion 212, the leaflet assembly 230 pulls the suture rod 2121 to move towards the direction close to the center of the stent 210, the suture rod 2121 is tilted towards the direction close to the center of the stent 210 under the pulling action of the leaflet, the included angle between the suture rod 2121 and the axis of the stent 210 is a2, the filling portion 222 is moved towards the direction close to the outflow end under the pulling action of the deformation of the suture rod 2121, the vertical distance between the filling portion 222 and the inflow end of the stent 210 is d2, and the filling portion 222 extrudes the protruding position between the native leaflet intermingled tissues. The distance d2 is greater than the distance d1. The included angle a1 is less than the included angle a2.

[0043] As shown in FIG. 12, FIG. 12 is a schematic diagram of the suture rod 2121 before and after deformation, wherein the dotted line is a schematic diagram of the suture rod 2121 before deformation, and the included angle between the suture rod 2121 when the leaflet assembly 230 is in the open state and the suture rod 2121 when the leaflet assembly 230 is in the closed state is a3.

[0044] In this way, by virtue of the fact that the stent 210 comprises the suture rod 2121 arranged along the axial direction of the stent 210, the leaflet assembly 230 is located on the inner side of the stent 210 and connected to the suture rod 2121, so that the opening and closing of the leaflet assembly 230 can pull the suture rod 2121 to move towards the direction close to the center of the stent 210 or drive the suture rod 2121 to move away from the center of the stent 210, and the filling portion 222 is connected to the suture rod 2121, so that the filling portion 222 can move towards the direction of the outflow end 241 along with the movement of the suture rod 2121, and thus the proximal end side portion of the filling portion 222 can extrude the protruding position between the native leaflet fusion tissues during the closing of the leaflet assembly 230, thereby facilitating the extrusion of the accumulated blood flow in the protruding position between the native leaflet fusion tissues and preventing the formation of thrombus in the region.

[0045] As shown in FIG. 13, the suture rod 2121 comprises a support segment 2123, which is located at a position close to the outflow end 241 of the stent 210, and the leaflet assembly 230 is connected to the support segment 2123, and the filling portion 222 is connected to one end of the suture rod 2121 close to the inflow end 242.

[0046] The suture rod 2121 comprises a first segment 2122, a second segment 2124 and a support segment 2123, the two ends of the support segment 2123 are connected to the first segment 2122 and the second segment 2124 respectively, the first segment 2122 of the suture rod 2121 is connected to the outflow end portion 211 of the stent 210, the second segment 2124 of the suture rod 2121 is connected to the inflow end portion 213 of the stent 210, the support segment 2123 is located between the first segment 2122 and the second segment 2124 and close to the outflow end portion 211, the leaflet assembly 230 is sutured, bonded or laser welded to the support segment 2123, and the filling portion 222 is sutured, bonded or laser welded to the second segment 2124 of the suture rod 2121.

[0047] It should be noted that the support section 2123 is located close to the outflow end 211 means that the axial midpoint of the support section 2123 is located on the side of the axial midpoint of the suture rod 2121 close to the outflow end 241, that is, the length from the second section 2124 to the midpoint of the support section 2123 is greater than the length from the first section 2122 to the midpoint of the support section 2123. The total length of the suture rod 2121 is defined as 1, and the length ratio of the first section 2122, the support section 2123 and the second section 2124 is x: y: z. The ratio of the length from the first section 2122 to the midpoint of the support section 2123 to the total length of the suture rod 2121 is x+y / 2. The ratio of the length from the second section 2124 to the midpoint of the support section 2123 to the total length of the suture rod 2121 is z+y / 2. Wherein x+y / 2<z+y / 2. For example, in an embodiment, the length ratio of the first section 2122, the support section 2123 and the second section 2124 on the suture rod 2121 is 1.5:2:3, the length ratio of the second section 2124 to the midpoint of the support section 2123 is 4, and the length ratio of the first section 2122 to the midpoint of the support section 2123 is 2.5. In this way, the length of the suture rod 2121 from the second section 2124 to the midpoint of the support section 2123 is greater than the length of the suture rod 2121 from the first section 2122 to the midpoint of the support section 2123.

[0048] In this way, by connecting the leaflet assembly 230 with the support section 2123, the connection of the leaflet assembly 230 with the suture rod 2121 is achieved, and by locating the support section 2123 close to the outflow end 241 of the suture rod 2121, the end of the suture rod 2121 close to the inflow end 242 is connected with the filling part 222, so that the support section 2123 and the filling part 222 are located on both sides of the axial midpoint of the suture rod 2121 respectively, thereby making the position of the maximum deformation of the suture rod 2121 under the pulling of the leaflets be located close to the inflow end 242 of the suture rod 2121, and further facilitating the filling part 222 to enter the protruding position between the intermingled tissues of the native leaflets after the deformation of the suture rod 2121.

[0049] As shown in FIG. 13, the support section 2123 is at least partially protruded towards the radial outside of the stent 210, and correspondingly, the corresponding part of the suture rod 2121 and the filling part 222 is also inclined towards the radial outside of the stent 210.

[0050] In the axial section of the valve prosthesis 200, the inner edge of the support section 2123 is located radially outward of the outflow end 211 or the inflow end 213, the second section 2124 of the suture rod 2121 is connected with the support section 2123, the second section 2124 is arranged obliquely relative to the axis of the stent 210, and the end of the second section 2124 close to the support section 2123 is located radially outward of the outflow end 211 or the inflow end 213. The angle between the second section 2124 and the axis of the stent 210 is between 10° and 45°, and specifically, the angle between the second section 2124 and the axis of the stent 210 is 10°, 15°, 25°, 30°, or 45°. The filling section 222 is connected with the second section 2124, and the filling section 222 is also arranged obliquely relative to the axis of the stent 210. The angle between the filling section 222 and the axis of the stent 210 is between 10° and 45°, and specifically, the angle between the filling section 222 and the axis of the stent 210 is 10°, 15°, 25°, 30°, or 45°.

[0051] For example, in one embodiment, when the leaflet assembly 230 is in the open state, the suture rod 2121 has been reset, the second section 2124 is in a state not pulled by the leaflet assembly 230, the force between the suture rod 2121 and the leaflet assembly 230 is small, the second section 2124 is arranged obliquely relative to the axis of the stent 210, the angle between the second section 2124 and the axis of the stent 210 is a1, the filling section 222 is arranged obliquely relative to the axis of the stent 210, the angle between the filling section 222 and the center of the axis of the stent 210 is a1, and the distance between the distal end of the filling section 222 (i.e., the end close to the outflow end 241) and the center of the axis of the stent 210 is c1. When the leaflet assembly 230 is in the closed state, the second section 2124 is in a state pulled by the leaflet assembly 230, the force between the suture rod 2121 and the leaflet assembly 230 is large, the angle between the suture rod 2121 and the axis of the stent 210 is a2, the angle between the filling section 222 and the center of the axis of the stent 210 is a2, and the distance between the distal end of the filling section 222 (i.e., the end close to the outflow end 241) and the center of the axis of the stent 210 is c2. c2 < c1. When the leaflet assembly 230 is in the closed state, the distal end of the filling section 222 (i.e., the end close to the outflow end 241) is closer to the outflow end 241 of the stent 210.

[0052] In this way, by virtue of the support section 2123 being at least partially protruding towards the radial outer side of the stent 210, the portion of the suture rod 2121 corresponding to the filling portion 222 is inclined towards the radial outer side of the stent 210, and the end of the filling portion 222 is arranged to be inclined relative to the end of the stent 210 when the suture rod 2121 is not pulled by the leaflet assembly 230, and the filling portion 222 moves along with the suture rod 2121 towards the radial inner side of the stent 210 when the suture rod 2121 is pulled by the leaflet assembly 230, so that the displacement of the distal end of the filling portion 222 in the axial direction of the stent 210 is relatively large, thereby facilitating the filling portion 222 to press the side wall of the commissure region of the native leaflet.

[0053] Referring back to FIG. 9, in an embodiment, the inner covering 2602 includes an inner covering connecting portion 2602a and an inner covering main body 2602b, the inner covering connecting portion 2602a protrudes towards the outflow end, and the inner covering connecting portion 2602a includes a commissure connecting portion 2602a1 and a transition portion 2602a2 connected to each other. In combination with FIG. 14, the commissure connecting portion 2602a1 is connected to the leaflet assembly 230 and the suture rod 2121, and the transition portion 2602a2 is used to connect the commissure connecting portion 2602a1 and the inner covering main body 2602b, the suture rod 2121 is supported on the surface of the transition portion 2602a2 and fixed on the transition portion 2602a2, so that the transition portion 2602a2 is kept unfolded in the axial direction and wrinkles are avoided, thereby avoiding blood aggregation in the transition portion 2602a2 to form thrombus.

[0054] Specifically, in an embodiment, the suture rod 2121 is supported on the surface of the transition portion 2602a2 and fixed on the transition portion 2602a2 by means of a third suture line 2204, and the third suture line 2204 is provided with a plurality of cross-stitch points 2204a along the suture rod 2121.

[0055] Referring back to FIG. 1 and FIG. 7, the inflow end portion 213 of the stent 210 includes a free end 2130 towards the outflow end, and the free end 2130 is adjacent to the leaflet assembly 230. In combination with FIG. 9, the inner covering 2602 further includes a protection portion 2602c, the protection portion 2602c is arranged between two adjacent commissure connecting portions 2602a1, one end of the protection portion 2602c is connected to the inner covering main body 2602b, and the other end of the protection portion 2602c extends towards the outflow end 241 first, then wraps around the free end 2130 from the inner surface to the outer surface of the stent 210, and then extends towards the inflow end 242 and is fixed, thereby avoiding the free end 2130 of the inflow end portion 213 of the stent 210 from contacting the leaflet assembly 230 and thereby abrading the leaflet assembly 230.

[0056] Any combination of the technical features in the above-described embodiments can be made, and for the sake of brevity, not all possible combinations are described, however, as long as the combination of the technical features does not exist in contradiction, it shall be considered within the scope of the present disclosure.

[0057] The above-described embodiments only express several implementation manners of the present application, and the description is relatively specific and detailed, but it shall not be understood as a limitation on the patent scope of the present application. It shall be pointed out that, for ordinary skilled persons in the art, several modifications and improvements can be made without departing from the concept of the present application, and these shall be within the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.

Claims

1. A valve prosthesis comprising an inflow end and an outflow end, characterized in that, The valve prosthesis comprises a stent, a sealing member and a covering film, the covering film at least covers a part of the stent near the inflow end, the sealing member comprises a sealing material, a first fixing member and a second fixing member, the sealing material comprises a first edge and a second edge arranged oppositely, the first edge or a nearby area of the first edge is fixed to the covering film by the first fixing member, then the second edge is close to the first edge by rolling or folding to form a ring structure arranged outside the covering film, and the ring structure is fixed to the covering film by the second fixing member.

2. The valve prosthesis of claim 1, wherein, When the first edge is fixed to the covering film by the first fixing member, a first protruding part is formed towards the outflow end, along the first protruding part, the second edge is close to the first edge by rolling or folding, so that the ring structure has a filling part protruding towards the outflow end.

3. The valve prosthesis of claim 2, wherein, The first edge comprises the first protruding part towards the outflow end, and the second edge is arranged in parallel with the first edge.

4. The valve prosthesis of claim 1, wherein, The second fixing member comprises a second suture, and the second suture comprises a plurality of loop lines, and the plurality of loop lines are wound around the surface of the ring structure.

5. The valve prosthesis of claim 1, wherein, At least one side of the ring structure near the inflow end overlaps the covering film.

6. The valve prosthesis of claim 2, wherein, The valve prosthesis further comprises a leaflet assembly, the covering film comprises an outer covering film and an inner covering film connected to each other, the inner covering film is arranged on the inner wall of the stent and connected to the leaflet assembly, and the outer covering film is arranged on the outer wall of the stent, one side of the outer covering film near the outflow end comprises a second protruding part towards the outflow end, the second protruding part is fixed to the first protruding part by the first fixing member, so that the second protruding part is axially spaced apart from the filling part.

7. The valve prosthesis of claim 2, wherein, The valve prosthesis further comprises a leaflet assembly, the stent comprises a plurality of suture rods, the leaflet assembly is arranged in a cavity surrounded by the plurality of suture rods and connected to the plurality of suture rods, the filling part is connected to the suture rods and located outside the suture rods.

8. The valve prosthesis of claim 7, wherein, The covering film comprises an outer covering film and an inner covering film connected to each other, the inner covering film is arranged on the inner wall of the stent and connected to the leaflet assembly, and the outer covering film is arranged on the outer wall of the stent, the inner covering film comprises an inner covering film connecting part and an inner covering film main body, the inner covering film connecting part protrudes towards the outflow end, the inner covering film connecting part comprises a commissure connecting part and a transition part connected to each other, the commissure connecting part is connected to the leaflet assembly and the suture rods, and the transition part is used for connecting the commissure connecting part and the inner covering film main body, the suture rods are supported on the surface of the transition part and fixed to the transition part, so that the transition part remains in an unfolded state in the axial direction.

9. The valve prosthesis of claim 8, wherein, The suture rods are supported on the surface of the transition part and fixed to the transition part by a third suture, and the third suture is provided with a plurality of cross-stitch points along the suture rods.

10. The valve prosthesis of claim 8, wherein, The stent comprises an inflow end part close to the inflow end, the inflow end part comprises a free end towards the outflow end, the free end is adjacent to the leaflet assembly, the inner covering further comprises a protection part, the protection part is arranged between two adjacent commissure connecting parts, one end of the protection part is connected with the inner covering main body, the other end of the protection part first extends towards the outflow end, then wraps the free end from the inner surface to the outer surface of the stent, and then extends towards the inflow end and is fixed.

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