Valve prosthesis

Abstract

The application discloses a valve prosthesis, comprising a stent and a sealing member, the sealing member is sleeved on the outer side wall of the stent, and the sealing member comprises a filling part which protrudes towards the direction of the outflow end of the stent. Thus, by arranging the sealing member around the outer side wall of the stent, the sealing member can fill the gap between the stent and the native valve ring, and by arranging the filling part of the sealing member, the filling part protrudes towards the direction of the outflow end of the stent, so that the filling part can extend into the semi-closed area at the commissure of the valve leaflets after implantation, thereby extruding the blood in the semi-closed area and preventing the blood from being retained in the semi-closed area to form a thrombus.

Description

Technical Field

[0001] This application relates to the field of interventional medical device technology, specifically to a valve prosthesis. Background Technology

[0002] This section provides only background information relevant to this disclosure and is not necessarily prior art.

[0003] When the native heart valve narrows, or leaks or regurgitates (e.g., due to leaflet calcification), heart valve replacement surgery can be performed. In one treatment option, the native valve can be removed and replaced with a bioprosthetic or mechanical valve. However, as... Figure 1 As shown, near the fusion site of the original leaflets, in order to prevent damage to blood vessels, the original leaflets at the fusion site are not completely removed, leaving some residual sclerotic tissue. In this location, the residual sclerotic tissue is prone to form a semi-closed area 110 with the seal, causing blood flow to flow back from the outflow end of the valve prosthesis into the semi-closed area 110 during the closure process of the leaflets, thus causing blood flow to stagnate in this gap and form a thrombus. Summary of the Invention

[0004] Therefore, it is necessary to provide a valve prosthesis including a stent and a seal, wherein the seal is fitted onto the outer wall of the stent and the seal includes a filling portion that 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 within the cavity formed by the multiple suture rods and connected to the multiple suture rods. The filling portion is connected to the suture rods and located outside the suture rods.

[0006] Optionally, the suture rod includes a support section disposed near the outflow end of the stent, the leaflet assembly is connected to the support section, and the filling portion is connected to the side of the suture rod near the inflow end of the stent.

[0007] Optionally, the support section protrudes at least partially toward the radially outer side of the support, and the portion of the suture rod corresponding to the filling portion is inclined toward the radially outer side of the support.

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

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

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

[0011] Optionally, multiple suture rods are spaced apart circumferentially along the support.

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

[0013] Optionally, the seal also includes a sealing portion fitted onto the side wall of the bracket, a filling portion connected to the sealing portion, the filling portion being located on the side of the sealing portion near the outflow end, and the thickness of the filling portion being the same as the thickness of the sealing portion.

[0014] Compared with the prior art, the beneficial effects of the valve prosthesis described in this invention are:

[0015] The present invention uses a sealing element that surrounds the outer wall of the stent, so that the sealing element can fill the gap between the stent and the original valve annulus. The sealing element includes a filling part that protrudes toward the outflow end of the stent, so that after the filling part is implanted, it can extend into the semi-closed area at the fusion of the leaflets, thereby squeezing out the blood in the semi-closed area and preventing blood from stagnating in the semi-closed area and forming a thrombus. Attached Figure Description

[0016] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0017] Figure 1 This is a schematic diagram of a semi-enclosed structure in the prior art;

[0018] Figure 2 This is a schematic diagram of the valve prosthesis in Embodiment 1 of the present invention;

[0019] Figure 3 This is a schematic diagram of the structure of the bracket in Embodiment 1 of the present invention;

[0020] Figure 4 This is a schematic diagram of the valve prosthesis in the closed state according to Embodiment 1 of the present invention;

[0021] Figure 5This is a schematic diagram of the valve prosthesis in the open state according to Embodiment 1 of the present invention;

[0022] Figure 6 This is a schematic diagram of the suture rod before and after deformation in Embodiment 1 of the present invention.

[0023] Figure 7 This is a schematic diagram of the connection structure between the suture rod and the inflow and outflow ends in Embodiment 1 of the present invention;

[0024] Figure 8 This is a schematic diagram of the connection structure of the first suture and the second suture in Embodiment 1 of the present invention;

[0025] Figure 9 This is a schematic diagram of the unfolded structure of the leaflet assembly in Embodiment 1 of the present invention;

[0026] Figure 10 For the present invention Figure 2 Enlarged schematic diagram of the structure at point A in the diagram;

[0027] Figure 11 This is a schematic diagram of the thickness of the filling portion in Embodiment 1 of the present invention;

[0028] Figure 12 This is a schematic diagram of the structure of the bracket in Embodiment 2 of the present invention;

[0029] Figure 13 This is a schematic diagram of the valve assembly in Embodiment 2 of the present invention;

[0030] Figure 14 This is a schematic diagram of the suture rod in Embodiment 2 of the present invention;

[0031] Figure 15 This is a schematic diagram of the suture rod from another perspective in Embodiment 2 of the present invention;

[0032] Figure 16 This is a schematic diagram of the deformation of the deformable arm in Embodiment 2 of the present invention;

[0033] Figure 17 This is a schematic diagram of the deformable arm in Embodiment 2 of the present invention;

[0034] Figure 18 For the present invention Figure 17 Enlarged schematic diagram of the structure at point B in the diagram;

[0035] Figure 19 This is a schematic diagram of the structure in Embodiment 2 of the present invention, in which the deformable arm and the support arm are on the same plane;

[0036] Figure 20 This is a schematic diagram of the valve prosthesis in Embodiment 2 of the present invention;

[0037] Figure 21 This is a schematic diagram of the connection structure between the first suture and the second suture in Embodiment 2 of the present invention. Detailed Implementation

[0038] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit 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 commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0040] In the field of interventional medical devices, "distal" is generally defined as the end furthest from the operator during surgery, and "proximal" is defined as the end closest to the operator during surgery. Valve prostheses typically have open and closed states. When the valve prosthesis is open, blood flow can pass through it; when it is closed, blood flow is impeded. When the valve prosthesis is open, refer to... Figure 2 The end where blood flows into the valve prosthesis is defined as the inflow end 242, and the end where blood flows out of the valve prosthesis is defined as the outflow end 241.

[0041] Example 1

[0042] This embodiment provides a valve prosthesis 200 for insertion into valves such as the aortic valve, mitral valve, tricuspid valve, or pulmonary valve to replace the original valve and achieve heart valve replacement. Figure 2 As shown, the valve prosthesis 200 includes a stent 210 and a seal 220. The seal 220 is disposed around the outer side wall of the stent 210. The seal 220 includes a filling portion 222, which is disposed along the axial direction of the stent 210 and protrudes toward the outflow end of the stent 210.

[0043] like Figure 3As shown, the stent 210 is suitable for implantation at the human valve annulus. The diameter of the stent 210 is larger than the diameter of the human valve annulus, and the stent 210 has a certain elastic deformation property to allow for 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, and its two axial ends are respectively connected to the outflow end 211 and the main body 212. The outflow end 211 includes a first wave-shaped annulus 2111 and a second wave-shaped annulus 2112. The first wave-shaped annulus 2111 and the second wave-shaped annulus 2112 are spaced apart along the axial direction of the stent 210. The first wave-shaped annulus 2111 and the second wave-shaped annulus 2112 are connected by a plurality of rod-shaped members, which are spaced apart along the circumference of the stent 210. The inflow end 213 includes a third wave-shaped annulus 2131 and a fourth wave-shaped annulus 2132, which are spaced apart along the axial direction of the support 210. The third wave-shaped annulus 2131 and the fourth wave-shaped annulus 2132 are connected by a plurality of rod-shaped members, which are spaced apart along the circumferential direction of the support 210. The main body 212 includes a plurality of suture rods 2121, which are spaced apart along the circumferential direction of the support 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 includes an open state and a closed state. When the leaflet assembly 230 is in the open state, blood flow can pass through the main body 212. When the leaflet assembly 230 is in the closed state, blood flow is obstructed by the leaflet assembly 230 and cannot pass through the main body 212.

[0045] like Figure 4 As shown, the stent 210 also includes a diaphragm 260 extending from the inflow end 213 to the main body 212, and a seal 220 is sutured to the diaphragm 260. The connecting end of the leaflet assembly 230 is sutured to the diaphragm 260. An opening is provided on the diaphragm 260, extending from the sutured connection between the leaflet assembly 230 and the diaphragm 260 toward the inflow end of the stent 210. When the leaflet assembly 230 is in the closed state, the leaflet assembly 230 is closed, and fluid extends from the through portion of the diaphragm 260 toward both radial sides of the stent 210 to enter the sinus portion of the aortic valve.

[0046] like Figure 4As shown, the sealing element 220 is arranged circumferentially along the stent 210. The sealing element 220 has an annular structure and is fitted onto the side wall of the stent 210, located radially outward of the stent 210. The sealing element 220 can be made of one or more materials such as bovine pericardium, porcine pericardium, silicone, or rubber. The sealing element 220 has certain elastic deformation properties. After the valve annulus is implanted, the outer wall of the sealing element 220 fits against the original valve annulus tissue, and the inner wall of the sealing element 220 fits against the outer wall of the stent 210. The sealing element 220 is used to seal the gap between the stent 210 and the original valve annulus tissue. The seal 220 includes a filling portion 222 and a sealing portion 221. The filling portion 222 is connected to the sealing portion 221. The filling portion 222 is located on the side of the sealing portion 221 near the outlet end of the bracket 210. The filling portion 222 extends from the inlet end of the bracket 210 to the outlet end of the bracket 210. The filling portion 222 is positioned toward the outlet end of the bracket 210, and the convex surface of the filling portion 222 faces the outlet end of the bracket 210.

[0047] After the valve prosthesis 200 is implanted at the position corresponding to the original valve annulus, the sidewall of the stent 210 fits against the original valve annulus and has a certain elastic force, thus fixing the valve prosthesis 200. The sealing member 220 is set around the outer sidewall of the stent 210, so that the sealing member 220 can fill the gap between the stent 210 and the original valve annulus. The sealing member 220 includes a filling part 222, which protrudes towards the outflow end of the stent 210. After the filling part 222 is implanted, it can extend into the semi-closed area 110 at the leaflet fusion, thereby squeezing out the blood in the semi-closed area 110 and preventing blood from stagnating in the semi-closed area 110 and forming a thrombus.

[0048] like Figure 2 , Figure 3 As shown, the stent 210 includes a suture rod 2121, which is arranged along the axial direction of the stent 210. Multiple suture rods 2121 are spaced apart along the circumferential direction of the stent 210. The leaflet assembly 230 is located inside the stent 210 and connected to the suture rod 2121. The filling part 222 is connected to the suture rod 2121.

[0049] The two ends of the suture rod 2121 are connected to the outflow end 211 and the inflow end 213 of the support 210, respectively. The suture rod 2121 is arranged along the axial direction of the support 210. There are multiple suture rods 2121, which are spaced apart circumferentially along the support 210, forming the main body 212. The leaflet assembly 230 is located inside the main body 212 and is sutured to the side wall of the suture rod 2121. The filling part 222 is sutured to the suture rod 2121, with one end of the filling part 222 near the outflow end of the support 210 connected to the suture rod 2121.

[0050] like Figure 4 As shown, during the process of the leaflet assembly 230 switching from the closed state to the open state, the heart is in a contracted state. The free end of the leaflet is subjected to the pressure of the heart chamber and moves away from the center of the main body 212. The leaflet pulls the suture rod 2121 away from the center of the stent 210. The suture rod 2121 is pulled away from the center of the stent 210 by the leaflet and moves away from the center of the stent 210 to reset. The filling part 222 resets with 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] like Figure 5 As shown, during the transition of the leaflet assembly 230 from the open to the closed state, the heart is in diastole. The free end 233 of the leaflet assembly 230 moves towards the center of the main body 212. The leaflet assembly 230 pulls the suture rod 2121 towards the center of the stent 210. The suture rod 2121 is pulled towards the center of the stent 210 by the leaflet, and the angle between the suture rod 2121 and the axis of the stent 210 is α2. The filling part 222 moves towards the outflow end due to the deformation and pulling effect of the suture rod 2121. The vertical distance between the filling part 222 and the inflow end of the stent 210 is d2. The filling part 222 compresses the original leaflet fusion tissue in the semi-closed region 110. The distance d2 is greater than the distance d1. The angle α1 < the angle α2.

[0052] like Figure 6 As shown, Figure 6 The diagram shows the suture rod 2121 before and after deformation. The dashed line represents the suture rod 2121 before deformation. The 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.

[0053] Thus, 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 inside the stent 210 and connected to the suture rod 2121. The opening and closing of the leaflet assembly 230 can pull the suture rod 2121 towards the center of the stent 210 or drive the suture rod 2121 away from the center of the stent 210. The filling part 222 is connected to the suture rod 2121, so that the filling part 222 can move towards the outflow end 241 following the movement of the suture rod 2121. This allows the proximal part of the filling part 222 to compress the semi-closed area 110 during the closing of the leaflet assembly 230, thereby facilitating the expulsion of accumulated blood flow in the semi-closed area 110 and preventing thrombus formation in this area.

[0054] As Figure 7 shown, the suture rod 2121 includes a support section 2123, which is located at a position of the suture rod 2121 close to the outflow end 241 of the stent 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 stent 210, and the second section 2124 of the suture rod 2121 is connected to the inflow end portion 213 of the stent 210. The support section 2123 is located between the first section 2122 and the second section 2124 and is close to the position of the outflow end portion 211. The leaflet assembly 230 is sutured or adhesively bonded to the support section 2123, and the filling part 222 is sutured or adhesively bonded to the second section 2124 of the suture rod 2121.

[0056] It should be noted that the support section 2123 being located close to the outflow end portion 211 means that the axial midpoint of the support section 2123 is on the side close to the outflow end 241 of the axial midpoint of the suture rod 2121. 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. Define the total length of the suture rod 2121 as: 1, and the length ratios of the first section 2122, the support section 2123 and the second section 2124 are 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 ratios of the first section 2122, the support section 2123 and the second section 2124 on the suture rod 2121 are: 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 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.

[0057] In this way, by connecting the leaflet assembly 230 with the support section 2123, the connection between the leaflet assembly 230 and the suture rod 2121 is realized. Then, by positioning the support section 2123 near the outflow end 241 of the suture rod 2121, and connecting the filling part 222 to the end of the suture rod 2121 near the inflow end 242, the support section 2123 and the filling part 222 are respectively located on both sides of the midpoint of the axis of the suture rod 2121. This makes the position of the suture rod 2121 with the maximum deformation due to the leaflet pull at the position of the suture rod 2121 near the inflow end 242, which facilitates the suture rod 2121 deforming and driving the filling part 222 into the semi-enclosed area 110.

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

[0059] When the leaflet assembly 230 is in the open state, the free end of the leaflet is located close to the inner wall of the support 210. The force between the leaflet assembly 230 and the suture rod 2121 is small, and there is basically no tension between the leaflet assembly 230 and the suture rod 2121. At this time, the filling part 222 is in the first position, and the distance between the distal end of the filling part 222 (i.e. the end close to the outflow end 241) and the inflow end 242 is d1. When the leaflet assembly 230 is in the closed state, under the pressure of the heart chamber, the free ends of the leaflets adhere together. The connecting ends of the leaflets pull the suture rod 2121 towards the center of the stent 210. The supporting section of the suture rod 2121 is also pulled towards the center of the stent 210 by the leaflets. The suture rod 2121 is tilted relative to the axial direction of the stent 210. The distal end of the filling part 222 follows the tilt of the suture rod 2121 and moves towards the longitudinal central axis. At this time, the filling part 222 is in the second position, and the distance from the distal end of the filling part 222 to the inflow end 242 is d2. d2>d1. Compared with the first position, the distal end of the filling part 222 is closer to the outflow end 241 in the second position.

[0060] It should be noted that within the heart chambers, when the leaflet assembly 230 is in the open state, the pressure in the heart chambers towards the outflow end of the stent 210 is typically lower, while when the leaflet assembly 230 is in the closed state, the pressure between the heart chambers and the leaflet assembly 230 is typically higher. During cardiac systole and diastole, especially when the leaflet assembly 230 is in the closed state, the pressure exerted by the heart pumping blood on the leaflet assembly 230 is greater. At this time, the leaflets are subjected to cardiac pressure, creating a pulling force that causes the suture rod 2121 to move towards the center of the stent 210.

[0061] In this way, when the leaflet assembly 230 is in the open state, the distal end of the filling part 222 is in the first position, and when the leaflet assembly 230 is in the closed state, the distal end of the filling part 222 is in the second position. The second position is located on the side of the first position near the outlet end 241 of the support 210, so that the opening and closing of the leaflet assembly 230 can drive the filling part 222 to move accordingly, thereby allowing the leaflet to drive the filling part 222 to squeeze the fusion area of ​​the original leaflet, thus facilitating the filling part 222 to squeeze the semi-closed area 110.

[0062] like Figure 7 As shown, the support section 2123 protrudes at least partially toward the radially outer side of the bracket 210, and correspondingly, the portion of the suture rod 2121 corresponding to the filling portion 222 also tilts toward the radially outer side of the bracket 210.

[0063] In the axial section of the valve prosthesis 200, the inner edge of the support segment 2123 is located radially outside the outflow end 211 or the inflow end 213. The second segment 2124 of the suture rod 2121 is connected to the support segment 2123. The second segment 2124 is inclined relative to the axis of the stent 210, and the end of the second segment 2124 near the support segment 2123 is located radially outside the outflow end 211 or the inflow end 213. The angle between the second segment 2124 and the axis of the stent 210 is between 10° and 45°. Specifically, the angle between the second segment 2124 and the axis of the stent 210 is 10°, 15°, 25°, 30°, or 45°. The filling part 222 is connected to the second segment 2124, and the filling part 222 is also inclined relative to the axis of the stent 210. The angle between the filling part 222 and the axis of the support 210 is between 10° and 45°. Specifically, the angle between the filling part 222 and the axis of the support 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 the support segment 2123 towards the radially outer side of the stent 210, the corresponding part of the suture rod 2121 and the filling portion 222 is inclined towards the radially outer side of 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 form extrusion on the side wall of the native leaflet fusion region.

[0066] Such as Figure 7As shown, the width of the portion connecting the suture rod 2121 to the filling part 222 is smaller than the width of the support section 2123. The diameter of the first segment 2122 and the second segment 2124 of the suture rod 2121 is smaller than the diameter of the support section 2123. The diameter of the first segment 2122 is between 0.7 and 1.3 mm, specifically, the diameter of the first segment 2122 is 0.7 mm, 0.9 mm, 1.1 mm, or 1.3 mm. The diameter of the second segment 2124 is between 0.7 and 1.3 mm, specifically, the diameter of the first segment 2122 is 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, the width of the first segment 2122 and the second segment 2124 of the suture rod 2121 is smaller than the width of the support segment 2123, making the stiffness of the first segment 2122 and the second segment 2124 lower than that of the support segment 2123. During the opening and closing of the leaflet assembly 230, the leaflet assembly 230 can more easily drive the first segment 2122 to deform, thereby facilitating the first segment 2122 to drive the proximal part of the filling part 222 (i.e. the part close to the inflow end 242) into the semi-closed area 110.

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

[0068] A suture hole 2125 is provided on the support section 2123, and the suture hole 2125 is arranged along the axial direction of the support 210. The leaflet assembly 230 is at least partially located within the suture hole 2125. A first suture 251 passes through the suture hole 2125 and the leaflet assembly 230, and sutures the leaflet assembly 230 within 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 section 2123 multiple times before being knotted for fixation, thereby achieving the connection between the leaflet assembly 230 and the support section 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 part 222 and is sutured to the filling part 222. The first suture 251 and the second suture 252 can be surgical sutures, PTFE sutures, or PET sutures.

[0069] Thus, during the opening and closing of the leaflet assembly 230, the leaflet assembly 230 deforms the suture rod 2121 by pulling it with the first suture 251. The outer wall of the suture rod 2121 deforms toward the inside of the support 210 to form a guide surface. The leaflet assembly 230 moves the filling part 222 toward the radial inside of the support 210 by pulling it with the second suture 252. Under the guidance of the guide surface, the filling part 222 moves toward the outflow end of the support 210, so that the filling part 222 can further enter the original leaflet fusion area. While there is still a gap between the seal 220 and the original leaflet fusion area, the semi-closed area 110 can be further filled.

[0070] like Figure 9 As shown, the leaflet assembly 230 includes a plurality of leaflets 231, with two adjacent leaflets 231 overlapping at least partially in the circumferential direction to form an overlap portion 234, the overlap portion 234 being at least partially accommodated within the suture hole 2125, and a second suture 252 connected to the overlap portion 234.

[0071] The leaflet assembly 230 includes multiple leaflets 231. Each leaflet 231 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. The free end 233 can move towards or away from the center of the main body 212 under the influence of cardiac pressure. In the unfolded schematic diagram of the leaflet assembly 230, the leaflet assembly 230 includes multiple leaflets 231. Each leaflet 231 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 a ring structure. 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. Leaflet 231 also includes overlapping portion 234, which is arranged circumferentially along the support 210. The overlapping portions 234 of two adjacent leaflets 231 overlap circumferentially. The overlapping portion 234 is located within the suture hole 2125 and is connected to the first suture 251, which sutures the overlapping portion 234 within the suture hole 2125. One end of the second suture 252 is sutured to the overlapping portion 234, and the other end of the second suture 252 is sutured to the filling portion 222.

[0072] In this way, by having the overlapping portion 234 of the leaflet 231 located within the suture hole 2125, the stress-bearing area of ​​the leaflet 231 within the suture hole 2125 is increased. Since both the first suture 251 and the second suture 252 are connected to the overlapping portion 234, the maximum tension 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 during the movement of the leaflet assembly 230 driving the suture rod 2121 and the filling portion 222.

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

[0074] A sealing portion 221 is disposed around the sidewall of the support 210. The sealing portion 221 has a through hole extending through both axial ends, and the inner wall of the through hole fits against the outer wall of the support 210. The sealing portion 221 can be sutured or bonded to the sidewall of the support 210. The outer wall of the sealing portion 221 is adapted to fit against the original valve annulus tissue. A 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, and the filling portion 222 can be integrally connected, sutured, or bonded to the sealing portion 221. Figure 11 As shown, 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 support 210. The inner edge of the filling portion 222 in the radial direction of the support 210 is fitted to the support 210, and the outer edge of the filling portion 222 in the radial direction of the support 210 is adapted to fit against the valve annulus tissue. Figure 10 As shown, 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 support 210. The radial inner edge of the sealing portion 221 fits against the support 210, and the radial outer edge of the sealing portion 221 is adapted to fit against the valve annulus tissue.

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

[0076] In this way, by positioning the filling portion 222 on the side of the sealing portion 221 near the outflow end, the filling portion 222 can fill the semi-closed area 110 between the sealing portion 221 and the hardened tissue, preventing the refluxed blood from accumulating in the semi-closed area 110 and forming a thrombus. By ensuring that the thickness of the filling portion 222 is the same as the thickness of the sealing portion 221, the outer edges of the sealing portion 221 and the outer edges of the filling portion 222 are located on the same circumferential plane, thereby increasing the contact stability between the seal 220 and the original valve annulus.

[0077] Example 2

[0078] like Figure 12 As shown, the difference between this embodiment and Embodiment 1 is that the valve prosthesis 300 includes a stent 310, which 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. 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, which is connected to the inner wall of the main body 312. 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 protruding 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 the point where the diameter of the main body 312 is maximum, its circumference is equal to the maximum circumference of the tubular structure. The main body 312 can be formed by laser cutting a tubular piece into a mesh structure followed by heat setting, or by weaving a braided filament material, or by a circumferential array of multiple rod-shaped pieces.

[0080] The outflow end 311 of the support 310 has an annular structure, with a diameter of d1 and a circumference of c1. The inflow end 313 of the support 310 also has an annular structure, with a diameter of d2 and a circumference of c2. The support section 3124 of the support 310 is located on the main body 312. The diameter of the main body 312 increases from both ends towards the support section 3124, with a diameter of d3 and a circumference of c3. The circumference of the support section 3124 is the maximum circumference of the main body 312. Wherein, d3 > d1, and d3 > d2. c3 > c1, and c3 > c2.

[0081] The leaflet assembly 330 is sutured to the support segment 3124. (As shown) Figure 13 As shown, the connecting end 332 of the leaflet 331 is connected to the support section 3124, and the overlapping portion 334 of the leaflet 331 is connected to the maximum circumference of the support section 3124. When the leaflet assembly 330 is open, 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 inside of the stent 310, making it difficult for blood flow on both sides of the leaflet assembly 330 to pass through the inside of the stent 310.

[0082] In this way, since the maximum circumference of the main body 312 is 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 that blood can pass through the leaflet assembly 330 and promote blood circulation.

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

[0084] One end of the suture rod 3121 is connected to the outflow end 311 of the support 310, and the other end of the suture rod 3121 is connected to the inflow end 313 of the support 310. Multiple suture rods 3121 are arranged in a circumferential array along the main body 312, with adjacent suture rods 3121 spaced apart. All suture rods 3121 enclose the main body 312. Figure 14 , Figure 15 As shown, the suture rod 3121 includes a support section 3124. The support section 3124 protrudes radially outward toward the support 310. The convex surface of the support section 3124 is arranged radially outward toward the support 310 and has an arc-shaped surface structure. The concave surface of the support section 3124 is arranged radially inward toward the support 310 and has an arc-shaped surface structure. The inner wall of the support section 3124 is located radially outward of the outflow end 311 and radially outward of the inflow end 313. The overlapping portion 334 of the leaflet assembly 330 is sutured within the support section 3124.

[0085] Thus, by means of the suture rod 3121 protruding radially outward toward the support 310, and the suture rod 3121 being at least partially located radially outward of the outflow end 311 or the inflow end 313, the main body 312 having at least a portion of its sidewall located radially outward of the outflow end 311 or the inflow end 313, is sutured to the sidewall of the suture rod 3121 located radially outward of the outflow end 311 or the inflow end 313 by the leaflet assembly 330, thereby making the maximum circumference of the leaflet assembly 330 greater than the maximum circumference of the outflow end 311 or the inflow end 313.

[0086] like Figure 14 , Figure 15As shown, the suture 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 support 310. The deformable arm 3124 is located radially inside the support arm 3123 and 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 inside the support arm 3123. The inner wall of the support arm 3123 and the outer wall of the deformable arm 3124 are spaced apart, with a certain gap between them. 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 from the bracket 310, and the concave surface faces radially inward from the bracket 310. The convex surface of the deformable arm 3124 faces radially outward from the bracket 310, and the concave surface faces radially inward from 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 located near the outflow end, and the second end 3124b is located near the inflow end. The first end 3124a is spaced apart from the outflow end 311 of the bracket 310, and 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 located between the first end 3124a of the deformable arm 3124 and the outflow end 311 of the bracket 310, and its two ends are respectively connected to the first end 3124a of the deformable arm 3124 and the outflow end 311 of the bracket 310. The second blocking section 3123b is located between the second end 3124b of the deformable arm 3124 and the outflow end 311 of the support 310. The two ends of the second blocking section 3123b are respectively connected to the second end 3124b of the deformable arm 3124 and the inflow end 313 of the support 310. The stiffness of the first blocking section 3123a is greater than the stiffness of the deformable arm 3124. The stiffness of the second blocking section 3123b is greater than the stiffness of the deformable arm 3124. The first blocking section 3123a and the second blocking section 3123b are used to form a deformation barrier between the deformable arm 3124 and the outflow end 311 or the inflow end 313 of the support 310, preventing the deformation of the deformable arm 3124 from causing the outflow end 311 or the inflow end 313 of the support 310 to move towards the axial center of the support 310.

[0089] The stiffness of the deformable arm 3124 is less than that of the support arm 3123. It should be noted that stiffness refers to the ability of a material or structure to resist elastic deformation under stress. The greater the stiffness, the more difficult the material or structure is to deform; the smaller the stiffness, the easier the material or structure is to deform. The width of the deformable arm 3124 is less than that of the support arm 3123, so that the stiffness of the deformable arm 3124 is less than that of the support arm 3123. It can be understood that in some other embodiments, the deformable arm 3124 has a bent structure, while the support arm 3123 has a straight structure.

[0090] like Figure 16 As shown, Figure 16 The dotted line shows the deformable arm 3124 after it has been stretched and deformed. During the transition from the open to the closed state of the leaflet assembly 330, under the pressure of the heart chambers, the free end 333 of the leaflet 331 moves towards the radial center of the stent 310. The leaflet 331 pulls the deformable arm 3124, causing it to deform radially inward towards the stent 310. The supporting arm 3123 maintains its shape or its deformation is less than that of the deformable arm 3124. During the transition from the closed to the open state of the leaflet assembly 330, the leaflet assembly 330 opens under the pressure of the heart chambers. The free end 333 of the leaflet 331 moves radially outward towards the stent 310. The deformable arm 3124 springs back to its pre-deformation state, and the supporting arm 3123 maintains its shape or its deformation is less than that of the deformable arm 3124.

[0091] Thus, the suture rod 3121 includes a support arm 3123 and a deformable arm 3124. The deformable arm 3124 is located radially inside the support arm 3123, and its stiffness is less than that of the support arm 3123, making it easier to deform than the support arm 3123. The deformable arm 3124 is then connected to the leaflet assembly 330. On the one hand, during the closing process of the leaflet assembly 330, the leaflet 331 can drive the deformable arm 3124 to move towards the radial center of the support 310, thereby promoting the closing of the leaflet 331. On the other hand, during the opening process of the leaflet assembly 330, the free end 333 of the leaflet 331 moves towards the radial outer direction of the support 310, and the deformable arm 3124, under the action of elastic restoring force, drives the leaflet 331 to move towards the radial outer direction of the support 310, 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 that of the deformable arm 3124, the support arm 3123 can provide support for the outflow end 311 and the inflow end 313 of the bracket 310, ensuring the structural stability of the bracket 310 and preventing the bracket 310 from being deformed by the pull of the leaflet assembly 330, which would cause the bracket 310 to shorten.

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

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

[0094] like Figure 18 As shown, the bending segment 3124 includes a first bending segment 3124c, a second bending segment 3124d, and a third bending segment 3124e. The two ends of the first bending segment 3124c are connected to the support arm 3123 and the second bending segment 3124d, respectively. The two ends of the second bending segment 3124d are connected to the first bending segment 3124c and the third bending segment 3124e, respectively. The two ends of the third bending segment 3124e are connected to the second bending segment 3124d and the support arm 3123, respectively. The first bending segment 3124c and the second bending segment 3124d are set at a predetermined angle, which is between 15° and 60°, specifically, it can be 15°, 30°, 45°, or 60°. The opening of the angle between the first bending segment 3124c and the second bending segment 3124d is arranged circumferentially along the bracket 310. The second bending segment 3124d and the third bending segment 3124e are arranged at a predetermined angle, which is between 15° and 60°, specifically 15°, 30°, 45°, or 60°. The opening of the angle between the second bending segment 3124d and the third bending segment 3124e is arranged circumferentially along the bracket 310, and the direction of the opening of the angle between the second bending segment 3124d and the third bending segment 3124e is opposite to the orientation of the opening of the angle between the first bending segment 3124c and the second bending segment 3124d. In some other embodiments, the opening of the angle between the first bending segment 3124c and the second bending segment 3124d may also be arranged radially along the bracket 310.

[0095] During the process of deformable arm 3124 deforming radially inward toward the support 310 under the pull of leaflet 331, the included angle between the first bent segment 3124c and the second bent segment 3124d increases, the included angle between the second bent segment 3124d and the third bent segment 3124e increases, and the support segment 3125 moves radially inward toward the support 310. After the pulling force on deformable arm 3124 is eliminated, the included angle between the first bent segment 3124c and the second bent segment 3124d decreases, the included angle between the second bent segment 3124d and the third bent segment 3124e decreases, and the support segment 3125 is restored to its original position under the pull of bent segment 3124.

[0096] In this way, by connecting the two ends of the support section 3125 to the two bending sections 3124 respectively, during the deformation of the deformable arm 3124, the two bending sections 3124 can provide a certain deformation margin for the movement of the support section 3125, preventing the deformation of the deformable arm 3124 from pulling the outflow end 311 and inflow end 313 of the bracket 310 toward the axial center of the bracket 310.

[0097] like Figure 17 As shown, a suture hole is formed on the support segment 3125. The leaflet assembly 330 includes multiple leaflets 331, which overlap at least partially in the circumferential direction 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. A suture hole is formed on the support segment 3125, and the suture hole is arranged along the axial direction of the support 310. The outline of the suture hole corresponds to the outline of the overlapping portion 334 of the valve. The overlapping portion 334 of the leaflets 331 is accommodated within the suture hole, and the overlapping portion 334 of the valve is sutured to the suture hole. The stiffness of the support segment 3125 is greater than that of the bent segment, the thickness of the support segment 3125 is greater than that of the bent segment, and the width of the support segment 3125 is greater than that of the bent segment.

[0098] The support section 3125 has a first suture hole 3125a and a second suture hole 3125b, which are arranged side by side, and a support rod is provided between the first suture hole 3125a and the second suture hole 3125b. The leaflet assembly 330 includes adjacent first leaflets and second leaflets. The overlapping portion 334 of the first leaflet passes 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 passes through the second suture hole 3125b and is partially located radially outside the second suture hole 3125b. The overlapping portions 334 of the first leaflet and the second leaflet are attached to each other on the radial sides of the first suture hole 3125a and the second suture hole 3125b. The overlapping portions 334 of the first leaflet and the second leaflet are sewn together on the radial sides of the first suture hole 3125a and the second suture hole 3125b, respectively. The overlapping portion 334 of the first leaflet 331 and the second leaflet 331 covers the support section 3125. The first suture 351 bypasses the side wall of the support section 3125 and connects the overlapping portion 334 of the first and second leaflets, so that the support section 3125, the first leaflet 331, and the second leaflet 331 are subjected to force as a whole. Therefore, during the movement of the leaflet assembly 330 pulling the support section 3125, the support section 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 section 3125, and improving the fatigue resistance of the leaflet assembly 330 during opening and closing. It is understood that in other embodiments, elliptical holes or strip-shaped holes may also be formed in the support section 3125.

[0099] In this way, during the deformation of the leaflet assembly 330 and the deformable arm 3124, the deformable arm 3124 includes a bending section 3124 and a support section 3125. The stiffness of the support section 3125 is greater than that of the bending section 3124. The overlapping part 334 of the leaflet assembly 330 is sewn into the suture hole, so that the deformation of the deformable arm 3124 is concentrated on the bending section 3124, while the support section 3125 maintains its shape basically unchanged. This reduces the possibility of the support section 3125 deforming and rubbing against the overlapping part 334 of the leaflet 331 or puncturing the leaflet 331 and damaging the leaflet 331.

[0100] like Figure 19As shown, the two 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 are located on the same axial plane p1 of the bracket 310, and the axial plane p1 passes through the radial center of the bracket 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 bracket 310 refers to the cross-section along the axial direction of the bracket 310. The radial center refers to the midpoint s1 of the diameter of the bracket 310.

[0101] In one embodiment, such as Figure 20 As shown, the support 310 includes a first suture rod 3141, a second suture rod 3142, and a third suture rod 3143. The first suture rod 3141, the second suture rod 3142, and the third suture rod 3143 are arranged circumferentially around the support 310. The first suture rod 3141 includes a first deformable arm 3124 and a first support arm 3123, which are located on an axial plane s1 (not shown in the figure). The second suture rod 3142 includes a second deformable arm 3124 and a second support arm 3123, which are located on an axial plane s2 (not shown in the figure). The third suture rod 3143 includes a third deformable arm 3124 and a third support arm 3123, which are located on an axial plane s3 (not shown in the figure). The axial planes s1, s2, and s3 pass through the radial center of the support 310.

[0102] In this way, since the center lines of the support arm 3123 and the deformable arm 3124 are located on the same axial plane of the bracket 310, and this axial plane passes through the radial center of the bracket 310, the support arm 3123 and the deformable 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 deformable arm 3124, the support arm 3123 and the deformable arm 3124 deform on the same axial plane, thereby avoiding the bracket 310 from tilting or twisting during the deformation of the deformable arm 3124.

[0103] like Figure 20 , Figure 21As shown, the seal 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. 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 near the inflow end. The filling part 322 is in contact with the outer side of the support arm 3123. The outer side wall of the support arm 3123 is inclined relative to the axial direction of the bracket 310. The outer side wall of the support arm 3123 is inclined toward the radial outer side of the bracket 310. The outer side 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 side wall of the support arm 3123.

[0104] like Figure 21 As shown, the first suture 351 is arranged around the support section 3125 and sutures the overlapping portion 334 into the suture hole. One end of the second suture 352 is connected to the overlapping portion 334 or the support section 3125, and the other end of the second suture 352 passes around the support arm 3123 and connects to the filling portion 322. There is a certain tension between the second suture 352 and the filling portion 322, and the second suture 352 can pull the filling portion 322 to deform. The filling portion 322 is attached to the side wall of the flow end. The filling portion 322 is not directly connected to the flow end 311 or the support arm 3123. After being pulled by the second suture 352, the filling portion 322 can deform towards the inflow end of the bracket 310.

[0105] During the process of switching from an open state to a closed state, the leaflet assembly 330 drives the deformable arm 3124 to move towards the radially inward direction of the support 310. The deformable arm 3124 pulls the filling part 322 towards the outflow end 311 of the support 310 through the second suture 352. Under the guidance of the outside of the support arm 3123, the filling part 322 moves towards the radially outward direction and the inflow end of the support 310, so that the filling part 322 can further enter the fusion area of ​​the original leaflet 331. While there is still a gap between the main body 312 of the seal and the fusion area of ​​the original leaflet 331, the semi-closed area 110 can be further filled.

[0106] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above 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 embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A valve prosthesis, characterized in that, The device includes a bracket and a seal, the seal being fitted onto the outer side wall of the bracket, and the seal including a filling portion that protrudes toward the outflow end of the bracket. The stent includes multiple suture rods and a leaflet assembly. The leaflet assembly is disposed in the cavity formed by the multiple suture rods and connected to the multiple suture rods. The end of the filling portion near the outflow end of the stent is connected to the suture rod and is located outside the suture rod. The leaflet assembly includes an open state and a closed state. When the leaflet assembly is in the open state, the filling part is in a first position. When the leaflet assembly is in the closed state, the filling part is in a second position. The first position is located on the side of the second position closer to the inflow end. The filling portion can move from the first position to the second position during the closure of the leaflet assembly, thereby squeezing the semi-closed area and squeezing out the accumulated blood flow within the semi-closed area.

2. The valve prosthesis according to claim 1, characterized in that, The suture rod includes a support section disposed near the outflow end of the stent, the leaflet assembly is connected to the support section, and the filling portion is connected to the side of the suture rod near the inflow end of the stent.

3. The valve prosthesis according to claim 2, characterized in that, The support section protrudes at least partially toward the radially outward side of the bracket, and the portion of the suture rod corresponding to the filling portion is inclined toward the radially outward side of the bracket.

4. The valve prosthesis according to claim 2, characterized in that, The width of the portion of the suture rod that connects to the filling section is smaller than the width of the support section.

5. The valve prosthesis according to claim 2, characterized in that, The valve prosthesis also includes a first suture and a second suture. A suture hole is provided on the support section. The first suture passes through the suture hole and connects to the leaflet assembly. One end of the second suture is connected to the suture hole or the leaflet assembly, and the other end of the second suture is connected to the filling part.

6. The valve prosthesis according to claim 5, characterized in that, The leaflet assembly includes at least two leaflets, with two adjacent leaflets at least partially overlapping in the circumferential direction to form an overlapping portion, the overlapping portion being at least partially accommodated within the suture hole, and the second suture connecting to the overlapping portion.

7. The valve prosthesis according to claim 1, characterized in that, Multiple suture rods are spaced apart circumferentially along the support.

8. The valve prosthesis according to claim 1, characterized in that, The sealing element further includes a sealing portion, which is sleeved on the side wall of the bracket. The filling portion is connected to the sealing portion and is located on the side of the sealing portion near the outlet end. The thickness of the filling portion is the same as the thickness of the sealing portion.

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