Valve prosthesis

Abstract

Disclosed in the present application is a valve prosthesis, comprising a stent and a sealing member. The sealing member is sleeved on an outer side wall of the stent. The sealing member comprises a filling part. The filling part protrudes towards an outflow end of the stent. Therefore, the sealing member surrounds the outer side wall of the stent, so that the sealing member can fill a gap between the stent and a native annulus; the sealing member comprises the filling part, and the filling part protrudes towards the outflow end of the stent, so that the filling part after implantation can extend into a semi-closed area at a commissure of a valve leaflet, thereby allowing the blood to be extruded from the semi-closed area, and thus preventing the blood from being retained in the semi-closed area to form a thrombus.

Description

Valve prosthesis Technical Field

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

[0002] This section merely provides background information related to the present disclosure and is not necessarily prior art.

[0003] When the native heart valve becomes narrow, or the native valve leaks or refluxes (such as leaflet calcification), heart valve replacement can be performed. In one treatment option, the native valve can be removed and replaced with a biological valve or a mechanical valve. However, as shown in FIG1 , near the fusion point of the native leaflets, in order to prevent damage to the blood vessels, the native leaflets at the fusion point of the leaflets will not be completely removed, leaving some residual hardened tissue. At this position, the residual hardened tissue is easy to enclose with the seal to form a semi-closed area 110, resulting in blood flow from the outflow end side of the valve prosthesis to the semi-closed area 110 during the closure of the leaflets, so that the blood flow is retained in the gap to form a thrombus. Summary of the Invention

[0004] Based on this, it is necessary to provide a valve prosthesis, including a stent and a seal, wherein the seal is sleeved on the outer side wall of the stent, and the seal includes a filling portion, which protrudes toward the outflow end of the stent.

[0005] Optionally, the stent includes multiple suture rods and a leaflet assembly, the leaflet assembly is disposed in a cavity surrounded by the multiple suture rods and connected to the multiple suture rods, and the filling part is connected to the suture rods and is located outside the suture rods.

[0006] Optionally, the suturing rod includes a support segment, which is arranged close to the outflow end of the stent, the leaflet assembly is connected to the support segment, and the filling part is connected to one side of the suturing rod close to the inflow end of the stent.

[0007] Optionally, the support segment at least partially protrudes toward the radial outside of the stent, and a portion of the suturing rod corresponding to the filling portion is inclined toward the radial outside of the stent.

[0008] Optionally, the width of the suture rod at the portion where it is connected to the filling portion is smaller than the width of the support section.

[0009] Optionally, the valve prosthesis also includes a first suture thread and a second suture thread. A suture hole is opened on the support segment. The first suture thread passes through the suture hole to connect to the leaflet assembly. One end of the second suture thread is connected to the suture hole or the leaflet assembly, and the other end of the second suture thread is connected to the filling part.

[0010] Optionally, the leaflet assembly includes at least two leaflets, and two adjacent leaflets at least partially overlap in the circumferential direction to form an overlapping portion, the overlapping portion is at least partially accommodated in the suture hole, and the second suture line is connected to the overlapping portion.

[0011] Optionally, a plurality of suture rods are spaced apart along the circumference of the stent.

[0012] Optionally, the leaflet assembly includes an open state and a closed state. When the leaflet assembly is in the open state, the filling portion is in a first position. When the leaflet assembly is in the closed state, the filling portion is in a second position. The first position is located on the side of the second position close to the inflow end.

[0013] Optionally, the seal also includes a sealing portion, which is sleeved on the side wall of the bracket, and the filling portion is connected to the sealing portion. The filling portion is located on the side of the sealing portion close to the outflow end, and the thickness of the filling portion is the same as the thickness of the sealing portion.

[0014] Compared with the prior art, the valve prosthesis of the present invention has the following beneficial effects:

[0015] The present invention arranges a seal around the outer wall of the stent so that the seal can fill the gap between the stent and the native valve ring. The seal includes a filling part, which protrudes toward the outflow end of the stent. After implantation, the filling part can extend into the semi-enclosed area where the leaflets blend, thereby squeezing out the blood in the semi-enclosed area and preventing blood from being retained in the semi-enclosed area to form a thrombus. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments recorded in this application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0017] FIG1 is a schematic diagram of a semi-enclosed structure in the prior art;

[0018] FIG2 is a schematic structural diagram of a valve prosthesis according to a first embodiment of the present invention;

[0019] FIG3 is a schematic structural diagram of a bracket in Example 1 of the present invention;

[0020] FIG4 is a schematic structural diagram of the valve prosthesis in the open state according to the first embodiment of the present invention;

[0021] FIG5 is a schematic structural diagram of the valve prosthesis in a closed state according to the first embodiment of the present invention;

[0022] FIG6 is a schematic diagram of the suturing rod before and after deformation in the first embodiment of the present invention; FIG.

[0023] 7 is a schematic diagram of the connection structure of the suturing rod and the inflow end and the outflow end in Example 1 of the present invention;

[0024] FIG8 is a schematic diagram of the connection structure of the first suture and the second suture in Example 1 of the present invention;

[0025] FIG9 is a schematic diagram of the expanded structure of the leaflet assembly in Example 1 of the present invention;

[0026] FIG10 is an enlarged schematic diagram of the structure at point A in FIG2 of the present invention;

[0027] FIG11 is a schematic diagram of the thickness of the filling portion in Example 1 of the present invention;

[0028] FIG12 is a schematic structural diagram of a bracket in a second embodiment of the present invention;

[0029] FIG13 is a schematic structural diagram of a valve assembly in Embodiment 2 of the present invention;

[0030] FIG14 is a schematic structural diagram of a suturing rod in a second embodiment of the present invention;

[0031] FIG15 is a schematic structural diagram of the suturing rod in another perspective of the second embodiment of the present invention;

[0032] FIG16 is a schematic diagram of the deformation of the deformable arm in the second embodiment of the present invention;

[0033] FIG17 is a schematic structural diagram of a deformable arm in a second embodiment of the present invention;

[0034] FIG18 is an enlarged schematic diagram of the structure at point B in FIG17 of the present invention;

[0035] FIG19 is a schematic structural diagram of a second embodiment of the present invention in which the deformable arm and the support arm are located on the same plane;

[0036] FIG20 is a schematic structural diagram of a valve prosthesis according to a second embodiment of the present invention;

[0037] FIG21 is a schematic diagram of the connection structure of the first suture thread and the second suture thread in the second embodiment of the present invention. DETAILED DESCRIPTION

[0038] To make the above-mentioned objects, features, and advantages of the present invention more readily apparent, specific embodiments of the present invention are described in detail below with reference to the accompanying drawings. The following description sets forth numerous specific details to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways than those described herein, and those skilled in the art may make similar modifications without departing from the scope of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0039] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in this specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0040] In the field of interventional medical devices, the "distal end" is generally defined as the end away from the operator during surgery, and the "proximal end" is defined as the end closer to the operator during surgery. A valve prosthesis typically has an open state and a closed state. When the valve prosthesis is in the open state, blood flow can pass through the valve prosthesis. When the valve prosthesis is in the closed state, blood flow is obstructed by the valve prosthesis. When the valve prosthesis is in the open state, referring to Figure 2, the end where blood flow enters the valve prosthesis is defined as the inflow end 242, and the end where blood flow exits the valve prosthesis is defined as the outflow end 241.

[0041] Example 1

[0042] This embodiment provides a valve prosthesis 200 for insertion into a valve such as the aortic valve, mitral valve, tricuspid valve, or pulmonary valve to replace the native valve and achieve heart valve replacement. As shown in FIG2 , the valve prosthesis 200 includes a stent 210 and a seal 220 . The seal 220 is disposed around the outer wall of the stent 210 and includes a filling portion 222 . The filling portion 222 is disposed axially along the stent 210 and protrudes toward the outflow end of the stent 210 .

[0043] As shown in FIG3 , the stent 210 is suitable for implantation in the human valve annulus. The diameter of the stent 210 is larger than the diameter of the human valve annulus. The stent 210 has a certain elastic deformation performance to achieve an interference fit with the human valve annulus. 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. The axial ends of the main body 212 are respectively connected to the outflow end 211 and the main body 212. The outflow end 211 includes a first wavy ring 2111 and a second wavy ring 2112. The first wavy ring 2111 and the second wavy ring 2112 are spaced apart along the axial direction of the stent 210. The first wavy ring 2111 and the second wavy ring 2112 are connected by a plurality of rod-shaped members. The plurality of rod-shaped members are spaced apart along the circumference of the stent 210. The inflow end portion 213 includes a third wavy ring 2131 and a fourth wavy ring 2132, which are spaced apart along the axial direction of the stent 210. The third wavy ring 2131 and the fourth wavy ring 2132 are connected by a plurality of rod-shaped members, which are spaced apart along the circumference of the stent 210. The main body portion 212 includes a plurality of suture rods 2121, which are spaced apart along the circumference of the stent 210.

[0044] The leaflet assembly 230 is connected to the inner wall of the main body 212 and is sutured to the suture rod 2121. The leaflet assembly 230 has an open state and a closed state. When the leaflet assembly 230 is in the open state, blood can flow through the main body 212. When the leaflet assembly 230 is in the closed state, blood flow is blocked by the leaflet assembly 230 and cannot pass through the main body 212.

[0045] As shown in FIG4 , the stent 210 further includes a coating 260, which extends from the inflow end 213 to the main body 212. The seal 220 is sutured to the coating 260. The connection end of the leaflet assembly 230 is sutured to the coating 260. The coating 260 has an opening extending from the location where the leaflet assembly 230 and the coating 260 are sutured toward the inflow end of the stent 210. When the leaflet assembly 230 is in a closed state, the leaflet assembly 230 is closed, and fluid extends from the through-portion of the coating 260 toward the radial sides of the stent 210 to enter the sinus of the aortic valve.

[0046] As shown in Figure 4, the seal 220 is arranged along the circumference of the stent 210. The seal 220 has an annular structure. The seal 220 is sleeved on the side wall of the stent 210. The seal 220 is located radially outside the stent 210. The seal 220 can be made of one or more materials such as bovine pericardium, porcine pericardium, silicone or rubber. The seal 220 has a certain elastic deformation performance. After the valve ring is implanted, the outer wall of the seal 220 fits with the native valve ring tissue, and the inner wall of the seal 220 fits with the outer wall of the stent 210. The seal 220 is used to block the gap between the stent 210 and the native valve ring tissue. The sealing part 220 includes a filling part 222 and a sealing part 221. The filling part 222 is connected to the sealing part 221. The filling part 222 is located on the side of the sealing part 221 close to the outflow end of the bracket 210. The filling part 222 extends from the inflow end of the bracket 210 to the outflow end of the bracket 210. The filling part 222 is set in the direction of the outflow end of the bracket 210, and the convex surface of the filling part 222 faces the outflow end of the bracket 210.

[0047] After the valve prosthesis 200 is implanted in the position corresponding to the native valve annulus, the side wall of the stent 210 fits the native valve annulus and has a certain elastic force, thereby achieving the fixation of the valve prosthesis 200. The seal 220 is arranged around the outer wall of the stent 210, so that the seal 220 can fill the gap between the stent 210 and the native valve annulus. The seal 220 includes a filling part 222, and the filling part 222 protrudes toward the outflow end of the stent 210, so that the filling part 222 can extend into the semi-enclosed area 110 where the leaflets blend after implantation, thereby squeezing out the blood in the semi-enclosed area 110 and preventing blood from being retained in the semi-enclosed area 110 to form a thrombus.

[0048] As shown in Figures 2 and 3, the stent 210 includes a suture rod 2121, which is arranged along the axial direction of the stent 210. Multiple suture rods 2121 are arranged at intervals along the circumference of the stent 210. The leaflet assembly 230 is located on the inner side of the stent 210 and is connected to the suture rod 2121. The filling part 222 is connected to the suture rod 2121.

[0049] The ends of the suture rod 2121 are respectively connected to the outflow end 211 and the inflow end 213 of the stent 210. The suture rod 2121 is arranged axially along the stent 210. There are multiple suture rods 2121, which are spaced apart along the circumference of the stent 210 and together form the main body 212. The leaflet assembly 230 is located inside the main body 212 and is sutured to the sidewalls of the suture rod 2121. The filling section 222 is sutured to the suture rod 2121, and the end of the filling section 222 closest to the outflow end of the stent 210 is connected to the suture rod 2121.

[0050] As shown in Figure 4, during the process of the leaflet assembly 230 switching from a closed state to an open state, the heart is in a contraction state, and the free end of the leaflet is subjected to the pressure of the heart chamber and moves toward a direction away from the center of the main body 212. The leaflet pulls the suture rod 2121 to move toward a direction away from the center of the stent 210. The suture rod 2121 is pulled by the leaflet and moves toward a direction away from the center of the stent 210 to reset. The filling part 222 is reset following the movement of the suture rod 2121. The angle between the suture rod 2121 and the axis of the stent 210 is a1, and the vertical distance between the filling part 222 and the inflow end of the stent 210 is d1.

[0051] As shown in FIG5 , during the transition of the leaflet assembly 230 from an open state to a closed state, the heart is in diastole, and the free end 233 of the leaflet assembly 230 moves toward the center of the main body 212. The leaflet assembly 230 pulls the suture rod 2121 toward the center of the stent 210. The suture rod 2121 is pulled by the leaflets and tilts toward the center of the stent 210. The angle between the suture rod 2121 and the axis of the stent 210 is a2. The filling portion 222 is pulled by the deformation of the suture rod 2121 and moves toward the outflow end. The vertical distance between the filling portion 222 and the inflow end of the stent 210 is d2. The filling portion 222 compresses the native leaflet fusion tissue in the semi-enclosed region 110. Distance d2 is greater than distance d1. Angle a1 is less than angle a2.

[0052] As shown in Figure 6, Figure 6 is a schematic diagram of the suturing rod 2121 before and after deformation, wherein the dotted line is a schematic diagram of the suturing rod 2121 before deformation, and the angle between the suturing rod 2121 when the leaflet assembly 230 is in an open state and the suturing rod 2121 when the leaflet assembly 230 is in a closed state is a3.

[0053] In this way, the stent 210 includes a suture rod 2121, which is arranged along the axial direction of the stent 210. The leaflet assembly 230 is located on the inner side of the stent 210 and is 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 toward the center of the stent 210, or drive the suture rod 2121 to move toward the center of the stent 210, and then connect with the suture rod 2121 through the filling part 222, so that the filling part 222 can follow the movement of the suture rod 2121 and move toward the outflow end 241, so that the proximal side of the filling part 222 can squeeze the semi-closed area 110 during the closing process of the leaflet assembly 230, thereby facilitating the squeezing out of the accumulated blood flow in the semi-closed area 110 and preventing thrombus formation in the area.

[0054] As shown in FIG. 7, the suture rod 2121 includes a support section 2123. The support section 2123 is located at a position of the suture rod 2121 close to the outflow end 241 of the bracket 210. The leaflet assembly 230 is connected to the support section 2123, and the filling part 222 is connected to one end of the suture rod 2121 close to the inflow end 242.

[0055] The suture rod 2121 includes a first section 2122, a second section 2124, and a support section 2123. The two ends of the support section 2123 are respectively connected to the first section 2122 and the second section 2124. The first section 2122 of the suture rod 2121 is connected to the outflow end portion 211 of the bracket 210, and the second section 2124 of the suture rod 2121 is connected to the inflow end portion 213 of the bracket 210. The support section 2123 is located between the first section 2122 and the second section 2124 and at a position close to the outflow end portion 211. The leaflet assembly 230 is sutured or bonded to the support section 2123, and the filling part 222 is sutured or bonded to the second section 2124 of the suture rod 2121.

[0056] It should be noted that the fact that the support section 2123 is located at a position close to the outflow end portion 211 means that the axial midpoint of the support section 2123 is 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 212 to the midpoint of the support section 2123. Define the total length of the suture rod 2121 as: 1, and the length ratio of the first section 2122, the support section 2123, and the second section 2124 as 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. x:y:z satisfies x + y / 2 < z + y / 2. For example, in one 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 from the second section 2124 to the midpoint of the support section 2123 is 4, and the length ratio from 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 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.

[0057] In this way, the connection between the leaflet assembly 230 and the support segment 2123 is realized, and the connection between the leaflet assembly 230 and the suture rod 2121 is realized. Then, the support segment 2123 is located at the position of the suture rod 2121 close to the outflow end 241, and the filling part 222 is connected to one end of the suture rod 2121 close to the inflow end 242, so that the support segment 2123 and the filling part 222 are respectively located on both sides of the midpoint of the axis of the suture rod 2121, so that the position of the suture rod 2121 with the maximum deformation amount due to the traction of the leaflet is located at the position of the suture rod 2121 close to the inflow end 242, which makes it easier for the suture rod 2121 to drive the filling part 222 into the semi-closed area 110 after deformation.

[0058] As shown in Figures 4 to 6, the leaflet assembly 230 includes an open state and a closed state. When the leaflet assembly 230 is in the open state, the filling portion 222 is in a first position. When the leaflet assembly 230 is in the closed state, the filling portion 222 is in a second position. The second position is located on the side of the first position close to the outflow end 241.

[0059] When the leaflet assembly 230 is in the open state, the free end of the leaflet is arranged close to the inner wall of the bracket 210, the force between the leaflet assembly 230 and the suture rod 2121 is small, and there is basically no pulling force between the leaflet assembly 230 and the suture rod 2121. At this time, the filling part 222 is in the first position, and the distal end of the filling part 222 (that is, the end close to the outflow end 241) is at a distance d1 from the inflow end 242. When the leaflet assembly 230 is in a closed state, the free ends of the leaflets are pressed against each other by the pressure of the heart chamber, and the connecting ends of the leaflets pull the suture rod 2121 toward the center of the stent 210. The support section of the suture rod 2121 is pulled by the leaflets and moves toward the center of the stent 210. The suture rod 2121 is tilted relative to the axial direction of the stent 210, and the distal end of the filling section 222 follows the tilt of the suture rod 2121 and moves toward the longitudinal center axis. At this time, the filling section 222 is in the second position, and the distance between the distal end of the filling section 222 and the inflow end 242 is d2. d2>d1. Compared with the first position, the distal end of the filling section 222 is closer to the outflow end 241 when in the second position.

[0060] It should be noted that within the heart chamber, when the leaflet assembly 230 is in the open state, the pressure from the heart chamber toward the outflow end of the stent 210 is generally low, whereas when the leaflet assembly 230 is in the closed state, the pressure between the heart chamber and the leaflet assembly 230 is generally high. During cardiac contraction and relaxation, especially when the leaflet assembly 230 is in the closed state, the heart pumps blood and exerts a high pressure on the leaflet assembly 230. At this time, the leaflets are subjected to the cardiac pressure, generating a pulling force that drives the suture rod 2121 toward the center of the stent 210.

[0061] In this way, when the leaflet assembly 230 is in an open state, the distal end of the filling part 222 is in a first position, and when the leaflet assembly 230 is in a closed state, the distal end of the filling part 222 is in a second position. The second position is located on the side of the outflow end 241 of the first position close to the stent 210, so that the opening and closing of the leaflet assembly 230 can drive the filling part 222 to move accordingly, so that the leaflet can drive the filling part 222 to squeeze the intersection of the native leaflets, thereby facilitating the filling part 222 to squeeze the semi-closed area 110.

[0062] As shown in FIG. 7 , the support segment 2123 at least partially protrudes toward the radially outer side of the stent 210 . Accordingly, the portion of the suture rod 2121 corresponding to the filling portion 222 is also tilted toward the radially outer side of the stent 210 .

[0063] In an axial cross-section of valve prosthesis 200, the inner edge of support segment 2123 is located radially outward of outflow end 211 or inflow end 213. Second segment 2124 of suture rod 2121 is connected to support segment 2123. Second segment 2124 is tilted relative to the axis of stent 210, with the end of second segment 2124 proximal to support segment 2123 located radially outward of outflow end 211 or inflow end 213. The angle between second segment 2124 and the axis of stent 210 is between 10° and 45°. Specifically, the angle between second segment 2124 and the axis of stent 210 is 10°, 15°, 25°, 30°, or 45°. Filling portion 222 is connected to second segment 2124 and is also tilted relative to the axis of stent 210. The angle between the filling portion 222 and the axis of the bracket 210 is between 10° and 45°. Specifically, the angle between the filling portion 222 and the axis of the bracket 210 is 10°, 15°, 25°, 30° or 45°.

[0064] For example, in one embodiment, when the leaflet assembly 230 is in the open state, the second segment 2124 is in a state where it is not pulled by the leaflet assembly 230. The force between the suture rod 2121 and the leaflet assembly 230 is small. The second segment 2124 is inclined relative to the axis of the stent 210, and the included angle between the second segment 2124 and the axis of the stent 210 is a1. The filling portion 222 is inclined relative to the axis of the stent 210, and the included angle between the filling portion 222 and the center of the axis of the stent 210 is a1. The distance between the distal end of the filling portion 222 (i.e., the end close to the outflow end 241) and the center of the axis of the stent 210 is t1. When the leaflet assembly 230 is in the closed state, the second segment 2124 is in a state where it is pulled by the leaflet assembly 230. The force between the suture rod 2121 and the leaflet assembly 230 is large. The included angle between the suture rod 2121 and the axis of the stent 210 is a2, the included angle between the filling portion 222 and the center of the axis of the stent 210 is a2, and the distance between the distal end of the filling portion 222 (i.e., the end close to the outflow end 241) and the center of the axis of the stent 210 is t2. t2 < t1. When the leaflet assembly 230 is in the closed state, the distal end of the filling portion 222 (the end close to the outflow end 241) is closer to the outflow end 241 of the stent 210.

[0065] In this way, by at least partially protruding radially outwardly towards the stent 210 in the support section 2123, the corresponding part of the suture rod 2121 and the filling portion 222 is inclined radially outwardly towards the stent 210. When the suture rod 2121 is not pulled by the leaflet assembly 230, the filling portion 222 is inclined relative to the end of the stent 210. When the suture rod 2121 is stretched by the leaflet assembly 230, the filling portion 222 moves towards the radially inner direction of the stent 210 following the suture rod 2121. The displacement amount of the distal end of the filling portion 222 in the axial direction of the stent 210 is large, so as to facilitate the filling portion 222 to squeeze the side wall of the native leaflet fusion region.

[0066] As shown in Figure 7, the width of the suture rod 2121 at the portion where it connects to the filling portion 222 is smaller than the width of the support section 2123. The diameters of the first and second sections 2122, 2124 of the suture rod 2121 are smaller than the diameter of the support section 2123. The diameter of the first section 2122 is between 0.7 and 1.3 mm, specifically, 0.7 mm, 0.9 mm, 1.1 mm, or 1.3 mm. The diameter of the second section 2124 is between 0.7 and 1.3 mm, specifically, 0.7 mm, 0.9 mm, 1.1 mm, or 1.3 mm. The diameter of the support section 2123 is between 1.0 and 1.8 mm. Specifically, the diameter of the support section 2123 can be 1.0 mm, 1.3 mm, 1.6 mm, or 1.8 mm. In this way, by making the width of the first section 2122 and the second section 2124 of the suture rod 2121 smaller than the width of the support section 2123, the stiffness of the first section 2122 and the second section 2124 is lower than that of the support section 2123. During the opening and closing process of the leaflet assembly 230, the leaflet assembly 230 can more easily drive the first section 2122 to deform, thereby facilitating the first section 2122 to drive the proximal side portion of the filling part 222 (i.e., the portion close to the inflow end 242) into the semi-closed area 110.

[0067] As shown in Figures 7 and 8, the valve prosthesis 200 also includes a first suture thread 251 and a second suture thread 252. A suture hole 2125 is provided on the support segment 2123. The first suture thread 251 passes through the suture hole 2125 to connect to the leaflet assembly 230. One end of the second suture thread 252 is connected to the suture hole 2125 or the leaflet assembly 230, and the other end of the second suture thread 252 is connected to the filling part 222.

[0068] The support segment 2123 is provided with a suture hole 2125, which is arranged along the axial direction of the stent 210, and the leaflet assembly 230 is at least partially located in the suture hole 2125. The first suture 251 passes through the suture hole 2125 and the leaflet assembly 230, and sews the leaflet assembly 230 into the suture hole 2125. For example, in one embodiment, the first suture 251 passes through the suture hole 2125 and the leaflet assembly 230, and wraps around the support segment 2123 multiple times before being knotted and fixed, thereby achieving the connection between the leaflet assembly 230 and the support segment 2123. One end of the second suture 252 is connected to the leaflet assembly 230, and the other end of the second suture 252 passes around the filling portion 222 and is sutured to the filling portion 222. The first suture 251 and the second suture 252 can be surgical sutures, PTFE sutures, or PET sutures.

[0069] In this way, during the opening and closing process of the leaflet assembly 230, the leaflet assembly 230 is deformed by pulling the suture rod 2121 through the first suture line 251, and the outer wall of the suture rod 2121 is deformed toward the inner side of the stent 210 to form a guide surface. The leaflet assembly 230 pulls the filling part 222 toward the radial inner side of the stent 210 through the second suture line 252, and the filling part 222 moves toward the outflow end of the stent 210 under the guidance of the guide surface, so that the filling part 222 can further enter the native leaflet fusion area, and the semi-closed area 110 can be further filled when there is still a gap between the sealing part 220 and the native leaflet fusion area.

[0070] As shown in Figure 9, the leaflet assembly 230 includes multiple leaflets 231, and two adjacent leaflets 231 at least partially overlap in the circumferential direction to form an overlapping portion 234. The overlapping portion 234 is at least partially accommodated in the suture hole 2125, and the second suture line 252 is connected to the overlapping portion 234.

[0071] The leaflet assembly 230 includes a plurality of leaflets 231, each of which includes a connecting end 232 and a free end 233. The connecting end 232 is connected to the inner wall of the main body 212 or the suture rod 2121, and the free end 233 can be moved toward the center of the main body 212 or away from the center of the main body 212 under the influence of cardiac pressure. In the expanded schematic diagram of the leaflet assembly 230, the leaflet assembly 230 includes a plurality of leaflets 231, each of which includes a free end 233 and a connecting end 232. The connecting ends 232 of all leaflets 231 are connected end to end to form an annular structure, and the connecting ends 232 of all leaflets 231 are connected to the inner wall of the stent 210. The free ends 233 of the leaflets 231 can move inside the stent 210 to open or close the leaflet assembly 230. The leaflets 231 further include overlapping portions 234, which are arranged along the circumference of the stent 210. The overlapping portions 234 of two adjacent leaflets 231 overlap circumferentially. The overlapping portions 234 are located within the suture hole 2125 and are connected to a first suture thread 251, which sutures the overlapping portions 234 within the suture hole 2125. One end of a second suture thread 252 is sutured to the overlapping portion 234, and the other end of the second suture thread 252 is sutured to the filling portion 222.

[0072] In this way, the overlapping portion 234 of the leaflet 231 is located in the suture hole 2125, which increases the force-bearing area of ​​the leaflet 231 located in the suture hole 2125. The first suture line 251 and the second suture line 252 are both connected to the overlapping portion 234, so that the maximum position of the pulling force of the leaflet 231 is located at the overlapping portion 234 of the leaflet 231, thereby reducing the stress damage to the leaflet 231 itself caused by the movement of the suture rod 2121 and the filling portion 222 driven by the leaflet assembly 230.

[0073] As shown in Figures 10 and 11, the sealing part 220 includes a sealing part 221, which is sleeved on the side wall of the bracket 210, and a filling part 222 is connected to the sealing part 221. The filling part 222 is located on the side of the sealing part 221 close to the outflow end, and the thickness of the filling part 222 is the same as the thickness of the sealing part 221.

[0074] The sealing portion 221 is disposed around the sidewall of the stent 210. A through-hole is formed in the sealing portion 221, extending axially through both ends of the sealing portion 221. The inner wall of the through-hole mates with the outer wall of the stent 210. The sealing portion 221 can be sutured or bonded to the sidewall of the stent 210. The outer wall of the sealing portion 221 is adapted to mate with native annular tissue. The filling portion 222 is connected to the axial end face of the sealing portion 221. The filling portion 222 is located on the side of the sealing peak near the outflow end. The filling portion 222 can be integrally connected to the sealing portion 221, sutured, or bonded. As shown in FIG11 , the thickness of the filling portion 222 refers to the distance t1 between the inner and outer edges of the filling portion 222 in the radial direction of the stent 210. The inner edge of the filling portion 222 in the radial direction of the stent 210 mates with the stent 210, and the outer edge of the filling portion 222 in the radial direction of the stent 210 mates with the stent 210. As shown in Figure 10, the thickness of the sealing portion 221 refers to the distance t2 between the inner and outer edges of the sealing portion 221 in the radial direction of the stent 210. The radial inner edge of the sealing portion 221 is in contact with the stent 210, and the radial outer edge of the sealing portion 221 is adapted to be in contact with the annular tissue.

[0075] In one embodiment, the sealing portion 221 and the filling portion 222 are integrally connected. Specifically, an annular member can be provided, wherein a portion of the annular member is bent and gathered toward the outflow end to form the filling portion 222, and the remaining portion of the annular member forms the sealing portion 221. In another embodiment, the sealing portion 221 is an annular member, and the filling portion 222 is sewn to the axial end surface of the sealing portion 221.

[0076] Thus, by positioning the filling portion 222 on the side of the sealing portion 221 closer to the outflow end, the filling portion 222 can fill the semi-enclosed region 110 between the sealing portion 221 and the sclerotic tissue, thereby preventing refluxed blood from accumulating and forming a thrombus in the semi-enclosed region 110. By ensuring that the thickness of the filling portion 222 is the same as that of the sealing portion 221, the outer edges of the sealing portion 221 and the filling portion 222 are located on the same circumferential plane, thereby increasing the stability of the contact between the sealing member 220 and the native annulus.

[0077] Example 2

[0078] As shown in Figure 12, the difference between this embodiment and Example 1 is that the valve prosthesis 300 includes a stent 310, the stent 310 includes an outflow end 311, an inflow end 313 and a main body 312, the two ends of the main body 312 are respectively connected to the outflow end 311 and the inflow end 313, and the maximum circumference of the main body 312 is greater than the maximum circumference of the outflow end 311 or the maximum circumference of the inflow end 313; it also includes a leaflet assembly 330, the leaflet assembly 330 is connected to the inner wall of the main body 312, and the maximum circumference of the leaflet assembly 330 is greater than the maximum circumference of the outflow end 311 and the inflow end 313.

[0079] The main body 312 has a tubular structure, with its circumferential sidewalls convex radially outward. The maximum diameter of the main body 312 is greater than the maximum diameter of either the outflow end 311 or the inflow end 313. At its maximum diameter, the circumference of the main body 312 is the maximum circumference of the tubular structure. The main body 312 can be formed by laser cutting a tubular member into a mesh structure and then heat-setting it, or by braiding a woven wire material. Alternatively, it can be formed by arranging multiple rod-like members in a circumferential array.

[0080] The outflow end 311 of the bracket 310 is annular in structure, with a diameter of d1 and a circumference of c1. The inflow end 313 of the bracket 310 is annular in structure, with a diameter of d2 and a circumference of c2. The support section 3124 of the bracket 310 is located on the main body 312. The diameter of the main body 312 increases gradually from the ends of the main body 312 to the support section 3124. The diameter of the support section 3124 is d3, and the circumference of the support section 3124 is c3. The circumference c3 of the support section 3124 is the maximum circumference of the main body 312. Here, d3>d1, d3>d2, c3>c1, and c3>c2.

[0081] The leaflet assembly 330 is sutured to the support segment 3124. As shown in Figure 13, the connection end 332 of the leaflet 331 is connected to the support segment 3124, and the overlapping portion 334 of the leaflet 331 is connected to the maximum circumference of the support segment 3124. After the leaflet assembly 330 is opened, the maximum circumference of the leaflet assembly 330 is the circumference c4 at the overlapping portion 334. The maximum circumference c4 of the leaflet assembly 330 is greater than the circumference c1 of the outflow end 311. The maximum circumference c4 of the leaflet assembly 330 is greater than the maximum circumference c2 of the inflow end 313. When the leaflet assembly 330 is in the open state, blood flows through the leaflet assembly 330 into the heart. When the leaflet assembly 330 is in the closed state, the leaflet assembly 330 forms a blockage on the inner side of the stent 310, and it is difficult for blood flow on both sides of the leaflet assembly 330 to pass through the inner side of the stent 310.

[0082] In this way, by making the maximum circumference of the main body 312 greater than the maximum circumference of the outflow end 311 or the inflow end 313, the leaflet assembly 330 is connected to the inner wall of the main body 312, so that the maximum circumference of the leaflet assembly 330 is greater than the maximum circumference of the outflow end 311 or the inflow end 313, thereby increasing the opening area of ​​the leaflet assembly 330, so as to facilitate blood flow through the leaflet assembly 330 and promote blood circulation.

[0083] As shown in Figure 12, the main body 312 includes a suture rod 3121, which protrudes radially outward. The suture rod 3121 is at least partially located radially outside the outflow end 311 or the inflow end 313. The leaflet assembly 330 is at least partially sutured on the suture rod 3121, and the leaflet assembly 330 is at least partially located radially outside the outflow end 311.

[0084] One end of the suture rod 3121 is connected to the outflow end 311 of the stent 310, and the other end of the suture rod 3121 is connected to the inflow end 313 of the stent 310. Multiple suture rods 3121 are arranged in a circumferential array along the main body 312, with two adjacent suture rods 3121 spaced apart. All suture rods 3121 enclose the main body 312. As shown in Figures 14 and 15, the suture rod 3121 includes a support segment 3124. The support segment 3124 protrudes radially outward from the stent 310. The convex surface of the support segment 3124 faces radially outward from the stent 310 and has an arcuate surface structure. The concave surface of the support segment 3124 faces radially inward from the stent 310 and has an arcuate surface structure. The inner wall of the support segment 3124 is located radially outward from the outflow end 311 and radially outward from the inflow end 313. The overlapping portion 334 of the leaflet assembly 330 is sewn into the support segment 3124.

[0085] Thus, by protruding the suture rod 3121 toward the radial outside of the bracket 310, the suture rod 3121 is at least partially located radially outside the outflow end 311 or the inflow end 313, so that at least part of the side wall of the main body 312 is located radially outside the outflow end 311 or the inflow end 313, and the leaflet assembly 330 is sutured to the side wall of the suture rod 3121 located radially outside the outflow end 311 or the inflow end 313, so that the maximum circumference of the leaflet assembly 330 is greater than the maximum circumference of the outflow end 311 or the inflow end 313.

[0086] As shown in Figures 14 and 15, the suturing rod 3121 includes a support arm 3123 and a deformable arm 3124. The two ends of the support arm 3123 are respectively connected to the outflow end 311 and the inflow end 313 of the bracket 310. The deformable arm 3124 is located radially inside the support arm 3123. The deformable arm 3124 is connected to the support arm 3123. The stiffness of the deformable arm 3124 is less than that of the support arm 3123. The leaflet assembly 330 is connected to the deformable arm 3124.

[0087] Both ends of the deformable arm 3124 are connected to the support arm 3123. The deformable arm 3124 is located radially inward of the support arm 3123. The inner wall of the support arm 3123 is spaced apart from the outer wall of the deformable arm 3124, with a certain distance between the inner wall of the support arm 3123 and the outer wall of the deformable arm 3124. Both the support arm 3123 and the deformable arm 3124 have an arc-shaped structure. The convex surface of the support arm 3123 faces radially outward of the bracket 310, while the concave surface of the support arm 3123 faces radially inward of the bracket 310. The convex surface of the deformable arm 3124 faces radially outward of the bracket 310, while the concave surface of the deformable arm 3124 faces radially inward of the bracket 310.

[0088] The deformable arm 3124 includes a first end 3124a and a second end 3124b, both of which are connected to the support arm 3123. The first end 3124a of the deformable arm 3124 is positioned closer to the outflow end, while the second end 3124b is positioned closer to the inflow end. The first end 3124a is spaced apart from the outflow end 311 of the bracket 310, while the second end 3124b is spaced apart from the inflow end 313 of the bracket 310. The support arm 3123 includes a first blocking section 3123a and a second blocking section 3123b. The first blocking section 3123a is positioned between the first end 3124a of the deformable arm 3124 and the outflow end 311 of the bracket 310. The first blocking section connects the first end 3124a of the deformable arm 3124 to the outflow end 311 of the bracket 310 at both ends. The second blocking section 3123b is located between the second end 3124b of the deformable arm 3124 and the outflow end 311 of the bracket 310. The two ends of the second blocking section 3123b respectively connect the second end 3124b of the deformable arm 3124 and the inflow end 313 of the bracket 310. The first blocking section 3123a has a greater rigidity than the deformable arm 3124. The second blocking section 3123b has a greater rigidity than the deformable arm 3124. The first blocking section 3123a and the second blocking section 3123b are configured to form a deformation barrier between the deformable arm 3124 and the outflow end 311 or the inflow end 313 of the bracket 310, thereby preventing the deformation of the deformable arm 3124 from causing the outflow end 311 or the inflow end 313 of the bracket 310 to move toward the axial center of the bracket 310.

[0089] The rigidity of the deformable arm 3124 is less than that of the support arm 3123. It should be noted that rigidity refers to the ability of a material or structure to resist elastic deformation when subjected to force. The greater the rigidity, the harder the material or structure is to deform, while the smaller the rigidity, the easier it is to deform. The width of the deformable arm 3124 is less than the width of the support arm 3123, so that the rigidity of the deformable arm 3124 is less than that of the support arm 3123. It is understood that in other embodiments, the deformable arm 3124 has a bent structure, while the support arm 3123 has a straight structure.

[0090] As shown in FIG16 , the deformable arm 3124 shown by the dotted line in FIG16 is a schematic diagram of the deformable arm 3124 after being pulled and deformed. During the process of switching the leaflet assembly 330 from the open state to the closed state, under the action of the pressure of the heart chamber, the free end 333 of the leaflet 331 moves toward the radial center of the stent 310. The leaflet 331 pulls the deformable arm 3124, causing the deformable arm 3124 to deform radially inwardly of the stent 310. The shape of the support arm 3123 remains unchanged or the deformation amount is less than the deformation amount of the deformable arm 3124. During the process of switching the leaflet assembly 330 from the closed state to the open state, the leaflet assembly 330 is opened under the action of the pressure of the heart chamber. The free end 333 of the leaflet 331 moves radially outwardly of the stent 310. The deformable arm 3124 rebounds to its pre-deformation state. The shape of the support arm 3123 remains unchanged or the deformation amount is less than the deformation amount of the deformable arm 3124.

[0091] In this way, the suture rod 3121 includes a support arm 3123 and a deformation arm 3124, and the deformation arm 3124 is located on the radial inner side of the support arm 3123. The stiffness of the deformation arm 3124 is less than that of the support arm 3123, so that the deformation arm 3124 is easier to deform than the support arm 3123, and then connected to the deformation arm 3124 through the leaflet assembly 330. On the one hand, during the closing process of the leaflet assembly 330, the leaflet 331 can drive the deformation arm 3124 to move toward the radial center of the stent 310 to promote the closing of the leaflet 331. During the opening process of the leaflet assembly 330, the free end 333 of the leaflet 331 moves toward the radial outer side of the stent 310, and the deformation arm 3124 drives the leaflet 331 to move toward the radial outer side of the stent 310 under the action of the elastic restoring force, thereby promoting the opening of the leaflet 331. On the other hand, by setting the stiffness of the support arm 3123 to be greater than the stiffness of the deformation arm 3124, the support arm 3123 can support the outflow end 311 and the inflow end 313 of the stent 310, thereby ensuring the structural stability of the stent 310 and preventing the stent 310 from being deformed after being pulled by the leaflet assembly 330 and causing the stent 310 to shorten.

[0092] As shown in FIG. 17 , the deformable arm 3124 includes a bending section 3124 and a supporting section 3125 . The two bending sections 3124 are respectively located at two ends of the supporting section 3125 , and the two ends of the supporting section 3125 are respectively connected to the two bending sections 3124 .

[0093] The bending section 3124 includes a first bending section 3124a and a second bending section 3124b. The first bending section 3124a and the second bending section 3124b are respectively located on either side of the support section 3125. One end of the first bending section 3124a is connected to the support section 3125, and the other end of the first bending section 3124a is connected to the support arm 3123. One end of the second bending section 3124b is connected to the support section 3125, and the other end of the second bending section 3124b is connected to the support arm 3123.

[0094] As shown in FIG18 , the bending section 3124 includes a first bending section 3124c, a second bending section 3124d, and a third bending section 3124e. The first bending section 3124c has two ends connected to the support arm 3123 and the second bending section 3124d, respectively. The second bending section 3124d has two ends connected to the first bending section 3124c and the third bending section 3124e, respectively. The third bending section 3124e has two ends connected to the second bending section 3124d and the support arm 3123. The first bending section 3124c and the second bending section 3124d are arranged at a predetermined angle. The angle between the first bending section 3124c and the second bending section 3124d is between 15° and 60°, and specifically, can be 15°, 30°, 45°, or 60°. The opening of the angle between the first and second bent segments 3124c, 3124d is arranged along the circumference of the stent 310. The second and third bent segments 3124d, 3124e are arranged at a predetermined angle. The angle between the second and third bent segments 3124d, 3124e is between 15° and 60°, specifically, 15°, 30°, 45°, or 60°. The opening of the angle between the second and third bent segments 3124d, 3124e is arranged along the circumference of the stent 310. The direction of the opening of the angle between the second and third bent segments 3124d, 3124e is opposite to the direction of the opening of the angle between the first and second bent segments 3124c, 3124d. In other embodiments, the opening of the angle between the first and second bent segments 3124c, 3124d can also be arranged along the radial direction of the stent 310.

[0095] As the deformable arm 3124 is pulled by the leaflet 331 and deformed radially inward of the stent 310, the angle between the first bent segment 3124c and the second bent segment 3124d increases, as does the angle between the second bent segment 3124d and the third bent segment 3124e, and the support segment 3125 moves radially inward of the stent 310. After the pulling force on the deformable arm 3124 is released, the angle between the first bent segment 3124c and the second bent segment 3124d decreases, as does the angle between the second bent segment 3124d and the third bent segment 3124e, and the support segment 3125 is pulled back into place by the bent segment 3124.

[0096] In this way, the two ends of the support segment 3125 are respectively connected to the two bending segments 3124. During the deformation of the deformation arm 3124, the two bending segments 3124 can provide a certain deformation margin for the movement of the support segment 3125, thereby preventing the deformation of the deformation arm 3124 from pulling the outflow end 311 and the inflow end 313 of the bracket 310 toward the axial center of the bracket 310.

[0097] As shown in FIG17 , a suture hole is defined in the support segment 3125. The leaflet assembly 330 includes a plurality of leaflets 331. The leaflets 331 at least partially overlap circumferentially to form an overlapping portion 334. The overlapping portion 334 of the valve is located within the suture hole and connected to the support segment 3125. The support segment 3125 is provided with a suture hole, which is arranged axially along the stent 310. The contour of the suture hole corresponds to the contour of the overlapping portion 334 of the valve. The overlapping portion 334 of the leaflets 331 is received within the suture hole, and the overlapping portion 334 of the valve is sutured and connected to the suture hole. The rigidity of the support segment 3125 is greater than that of the bending segment. The thickness of the support segment 3125 is greater than that of the bending segment. The width of the support segment 3125 is greater than that of the bending segment.

[0098] The support section 3125 is provided with a first suture hole 3125a and a second suture hole 3125b. The first suture hole 3125a and the second suture hole 3125b are arranged in parallel, and a support rod is provided between the first suture hole 3125a and the second suture hole 3125b. The leaflet assembly 330 includes an adjacent first leaflet and a second leaflet, the overlapping portion 334 of the first leaflet is passed through the first suture hole 3125a and is partially located radially outside the first suture hole 3125a, the overlapping portion 334 of the second leaflet is passed through the second suture hole 3125b and is partially located radially outside the second suture hole 3125b, the overlapping portion 334 of the first leaflet and the overlapping portion 334 of the second leaflet are fitted together on both radial sides of the first suture hole 3125a and the second suture hole 3125b, the overlapping portion 334 of the first leaflet 334 and the overlapping portion 334 of the second leaflet are sutured on both radial sides of the first suture hole 3125a and the second suture hole 3125b respectively, and the overlapping portion 334 of the first leaflet 331 and the second leaflet 331 covers the support segment 3125. The first suture 351 passes around the sidewall of the support segment 3125 and connects the overlapping portion 334 of the first and second leaflets, so that the support segment 3125, the first leaflet 331, and the second leaflet 331 are subjected to force as a whole. Thus, when the leaflet assembly 330 pulls the support segment 3125 to move, the support segment 3125 increases the contact area between the overlapping portion 334 of the leaflet assembly 330 and the deformable arm 3124, thereby reducing stress concentration between the overlapping portion 334 of the leaflet assembly 330 and the support segment 3125, thereby improving the fatigue resistance of the leaflet assembly 330 during opening and closing. It is understood that in other embodiments, an elliptical hole or a strip-shaped hole may also be provided in the support segment 3125.

[0099] In this way, in the process of the leaflet assembly 330 driving the deformation arm 3124 to deform, the deformation arm 3124 includes a bending section 3124 and a support section 3125, and the stiffness of the support section 3125 is greater than the stiffness of the bending section 3124. The overlapping portion 334 of the leaflet assembly 330 is sutured in the suture hole, so that the deformation of the deformation arm 3124 is concentrated on the bending section 3124, while the support section 3125 maintains a basically unchanged shape, thereby reducing the possibility of the deformation of the support section 3125 rubbing against the overlapping portion 334 of the leaflet 331 or puncturing the leaflet 331 and damaging the leaflet 331.

[0100] As shown in Figure 19, the ends of the deformable arm 3124 are connected to the support arm 3123. The centerline l1 of the support arm 3123 and the centerline l2 of the deformable arm 3124 lie on the same axial plane p1 of the stent 310. The axial plane p1 passes through the radial center of the stent 310. The centerline of the deformable arm 3124 refers to the line l1 connecting the midpoints of the two ends of the deformable arm 3124, and the centerline of the support arm 3123 refers to the line l2 connecting the midpoints of the two ends of the support arm 3123. The axial plane of the stent 310 refers to a cross-section along the axial direction of the stent 310. The radial center refers to the midpoint s1 of the diameter of the stent 310.

[0101] In one embodiment, as shown in Figure 20, the bracket 310 includes a first suture rod 3141, a second suture rod 3142 and a third suture rod 3143, which are arranged at intervals along the circumference of the bracket 310, and the first suture rod 3141 includes a first deformation arm 3124 and a first support arm 3123, and the first deformation arm 3124 and the first support arm 3123 are located on an axial plane s1 (not shown in the figure), the second suture rod 3142 includes a second deformation arm 3124 and a second support arm 3123, and the second deformation arm 3124 and the second support arm 3123 are located on an axial plane s2 (not shown in the figure), and the third suture rod 3143 includes a third deformation arm 3124 and a third support arm 3123, and the third deformation arm 3124 and the third support arm 3123 are located on an axial plane s3 (not shown in the figure), and the axial plane s1, the axial plane s2 and the axial plane s3 respectively pass through the radial center of the bracket 310.

[0102] In this way, the center line of the support arm 3123 and the center line of the deformation arm 3124 are located on the same axial plane of the bracket 310, and the axial plane passes through the radial center of the bracket 310, so that the support arm 3123 and the deformation arm 3124 located on the same suture rod 3121 are both located on the axial plane of the bracket 310. During the deformation of the deformation arm 3124, the support arm 3123 and the deformation arm 3124 are both deformed on the same axial plane, thereby avoiding the bracket 310 from tilting or twisting during the deformation of the deformation arm 3124.

[0103] As shown in Figures 20 and 21, the sealing part 320 includes a sealing part 321 and a filling part 322. The sealing part 321 is sleeved on the inflow end 313 of the bracket 310, and the filling part 322 is connected to one axial end of the sealing part 321. The filling part 322 is located on the side of the sealing part 321 close to the inflow end. The filling part 322 is in contact with the outer arm of the support arm 3123. The outer wall of the support arm 3123 is tilted relative to the axial direction of the bracket 310. The outer wall of the support arm 3123 is tilted toward the radial outside of the bracket 310. The outer wall of the support arm 3123 forms a guide surface for the movement of the filling part 322. The filling part 322 is at least partially in contact with the outer wall of the support arm 3123.

[0104] As shown in FIG21 , a first suture 351 is disposed around the support segment 3125 and sews the overlapping portion 334 into the suture hole. One end of a second suture 352 is connected to the overlapping portion 334 or the support segment 3125, while the other end of the second suture 352 passes around the support arm 3123 and is connected to the filling portion 322. A certain tension exists between the second suture 352 and the filling portion 322, allowing the second suture 352 to pull the filling portion 322 to deform. The filling portion 322 adheres to the sidewall of the inflow end portion and is not directly connected to the outflow end portion 311 or the support arm 3123. Under the tension of the second suture 352, the filling portion 322 can deform toward the inflow end portion of the stent 310.

[0105] During the process of switching the leaflet assembly 330 from an open state to a closed state, the leaflet assembly 330 drives the deformation arm 3124 to move toward the radial inner side of the stent 310, and the deformation arm 3124 pulls the filling part 322 to deform toward the outflow end 311 of the stent 310 through the second suture line 352. Under the guidance of the outer side of the support arm 3123, the filling part 322 moves toward the radial outer side and the inflow end of the stent 310, so that the filling part 322 can further enter the fusion area of ​​the native leaflet 331, and the semi-closed area 110 can be further filled when there is still a gap between the main body 312 of the seal 320 and the fusion area of ​​the native leaflet 331.

[0106] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0107] The above-described embodiments merely represent several implementation methods of the present invention. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make various modifications and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A valve prosthesis, characterized in that: It comprises a support and a sealing member, wherein the sealing member is sleeved on the outer side wall of the support, and the sealing member comprises a filling portion, and the filling portion protrudes toward the outflow end of the support.

2. The valve prosthesis according to claim 1, characterized in that: The stent includes a plurality of suturing rods and a leaflet assembly. The leaflet assembly is disposed in a cavity surrounded by the plurality of suturing rods and connected to the plurality of suturing rods. The filling portion is connected to the suturing rods and is located outside the suturing rods.

3. The valve prosthesis according to claim 2, characterized in that: The suturing rod comprises a supporting section, the supporting section is arranged close to the outflow end of the stent, the leaflet assembly is connected to the supporting section, and the filling part is connected to one side of the suturing rod close to the inflow end of the stent.

4. The valve prosthesis according to claim 3, characterized in that: The support segment at least partially protrudes toward the radial outer side of the stent, and a portion of the suturing rod corresponding to the filling portion is inclined toward the radial outer side of the stent.

5. The valve prosthesis according to claim 3, characterized in that: The rod width of the portion where the suturing rod is connected to the filling portion is smaller than the rod width of the supporting section.

6. The valve prosthesis according to claim 3, characterized in that: The valve prosthesis also includes a first suture thread and a second suture thread. A suture hole is opened on the support segment. The first suture thread passes through the suture hole to connect to the leaflet assembly. One end of the second suture thread is connected to the suture hole or the leaflet assembly, and the other end of the second suture thread is connected to the filling part.

7. The valve prosthesis according to claim 6, characterized in that: The leaflet assembly includes at least two leaflets, and two adjacent leaflets at least partially overlap in the circumferential direction to form an overlapping portion, the overlapping portion is at least partially accommodated in the suture hole, and the second suture line is connected to the overlapping portion.

8. The valve prosthesis according to claim 2, characterized in that: A plurality of suture rods are arranged at intervals along the circumference of the stent.

9. The valve prosthesis according to claim 2, characterized in that: The leaflet assembly includes an open state and a closed state. When the leaflet assembly is in the open state, the filling portion is in a first position. When the leaflet assembly is in the closed state, the filling portion is in a second position. The first position is located on a side of the second position close to the inflow end.

10. The valve prosthesis according to claim 1, characterized in that: The sealing member further comprises a sealing portion, which is sleeved on the side wall of the bracket, the filling portion is connected to the sealing portion, the filling portion is located on a side of the sealing portion close to the outflow end, and the thickness of the filling portion is the same as that of the sealing portion.

11. The valve prosthesis according to claim 3, characterized in that: The valve prosthesis includes an inflow end, an outflow end and a main body, wherein the two ends of the main body are respectively connected to the inflow end and the outflow end, and the maximum circumference of the main body is greater than the maximum circumference of the inflow end or the maximum circumference of the outflow end; and also includes a leaflet assembly, which is connected to the inner wall of the main body, and the maximum circumference of the leaflet assembly is greater than the maximum circumference of the inflow end or the maximum circumference of the outflow end.

12. The valve prosthesis according to claim 11, characterized in that: The suturing rod protrudes toward the radial outside, and at least a portion of the suturing rod is located radially outside the inflow end portion or the outflow end portion.

13. The valve prosthesis according to claim 12, characterized in that: The suturing rod includes a supporting arm and a deforming arm connected to each other, and the deforming arm includes the supporting segment; the deforming arm is located radially inside the supporting arm, the rigidity of the deforming arm is smaller than the rigidity of the supporting arm, and the leaflet assembly is connected to the deforming arm.

14. The valve prosthesis according to claim 13, characterized in that: Two ends of the support arm and two ends of the deformable arm are respectively connected, a center line of the support arm and a center line of the deformable arm are located on the same axial plane, and the axial plane radially passes through the radial center of the main body.

15. The valve prosthesis according to claim 13, characterized in that: The deformable arm further includes bending sections located at both ends of the supporting section, and the bending sections are connected to the supporting arm.

16. The valve prosthesis according to any one of claims 11 to 15, characterized in that: The sealing member is sleeved on the inflow end portion, and the sealing member and the leaflet assembly at least partially overlap in the axial direction.

17. The valve prosthesis according to claim 16, characterized in that: The heart valve further includes a covering membrane, which covers a side wall of the inflow end portion and extends from the inflow end portion to the sealing member.

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