Valve prosthesis

Abstract

The valve prosthesis comprises an inflow end part, an outflow end part and a main body part, the two ends of the main body part are connected with the inflow end part and the outflow end part respectively, and the maximum perimeter of the main body part is larger than that of the inflow end part or the outflow end part; the valve further comprises a valve leaflet assembly, the valve leaflet assembly is connected with the inner wall of the main body part, and the maximum perimeter of the valve leaflet assembly is larger than the maximum perimeter of the inflow end part or the outflow end part. Therefore, the maximum perimeter of the main body part is larger than the maximum perimeter of the inflow end part or the outflow end part, and the valve leaflet assembly is connected with the inner wall of the main body part, so that the maximum perimeter of the valve leaflet assembly is larger than the maximum perimeter of the outflow end part or the outflow end part, the opening area of the valve leaflet assembly is increased, blood can conveniently pass through the valve leaflet assembly, and blood circulation is promoted.

Description

Technical Field

[0001] This application relates to the technical field of interventional medical devices, and particularly relates to a valve prosthesis. Background Art

[0002] What is provided in this section is only background information related to the present disclosure, and it is not necessarily prior art.

[0003] When the native heart valve narrows, or the native valve leaks or regurgitates (such as leaflet calcification), heart valve replacement can be performed. In one treatment option, the native valve can be excised and replaced with a biological valve or a mechanical valve. However, as Figure 1 shown, near the native leaflet fusion site, in order to prevent damage to blood vessels, the native leaflets at the leaflet fusion site are not completely excised, thus leaving some residual hardened tissue. At this position, the residual hardened tissue is prone to enclose with the seal to form a semi-closed area 110, resulting in blood flow regurgitating from the outflow end side of the valve prosthesis into the semi-closed area 110 during the closing of the leaflets, thereby causing blood flow to stagnate in this gap and form a thrombus accumulation. Summary of the Invention

[0004] Based on this, it is necessary to provide a valve prosthesis, including an inflow end portion, an outflow end portion, and a main body portion. The two ends of the main body portion are respectively connected to the inflow end portion and the outflow end portion, and the maximum circumference of the main body portion is greater than the maximum circumference of the inflow end portion or the outflow end portion; it further includes a leaflet assembly, the leaflet assembly is connected to the inner wall of the main body portion, and the maximum circumference of the leaflet assembly is greater than the maximum circumference of the inflow end portion or the outflow end portion.

[0005] Optionally, the main body portion includes a suture rod, the suture rod protrudes towards the radially outer side, at least part of the suture rod is located radially outside the inflow end portion or the outflow end portion, and the leaflet assembly is connected to the suture rod.

[0006] Optionally, the suture rod includes a connected support arm and a deformation arm, the deformation arm is located radially inside the support arm, and the stiffness of the deformation arm is less than the stiffness of the support arm, and the leaflet assembly is connected to the deformation arm.

[0007] Optionally, the deformation arm is provided with suture holes, the leaflet assembly includes a plurality of leaflets, adjacent leaflets at least partially overlap in the circumferential direction, and the overlapping part of the leaflets is located in the suture holes and is connected to the deformation arm.

[0008] Optionally, the two ends of the support arm and the two ends of the deformation arm are respectively connected, the center line of the support arm and the center line of the deformation arm are located in the same axial plane, and the axial plane radially passes through the radial center of the main body portion.

[0009] Optionally, the deformation arm includes a support section and bending sections located at both ends of the support section, the bending sections are connected to the support arm, and the leaflet assembly is connected to the support section.

[0010] Optionally, a plurality of suture rods are arranged at circumferential intervals along the main body portion.

[0011] Optionally, the valve prosthesis further includes a seal, the seal is sleeved on the inflow end portion, the seal and the leaflet assembly at least partially overlap axially, and the seal includes a filling portion, and the filling portion protrudes toward the outflow end.

[0012] Optionally, the valve prosthesis further includes a film, the film covers the side wall of the inflow end portion, and the film extends from the inflow end to the seal.

[0013] Optionally, the valve prosthesis further includes a suture, one end of the suture is connected to the filling portion, and the other end of the suture is connected to the deformation arm.

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

[0015] In the present invention, the maximum circumference of the main body portion is greater than the maximum circumference of the inflow end portion or the outflow end portion, and the leaflet assembly is connected to the inner wall of the main body portion, so that the maximum circumference of the leaflet assembly is greater than the maximum circumference of the outflow end portion or the outflow end portion, thereby increasing the opening area of the leaflet assembly, facilitating blood flow through the leaflet assembly, and promoting blood circulation. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments recorded in the present application. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0017] Figure 1 Schematic diagram of a semi-closed structure in the prior art;

[0018] Figure 2 Schematic diagram of the structure of the valve prosthesis in Embodiment 1 of the present invention;

[0019] Figure 3 Schematic diagram of the structure of the stent in Embodiment 1 of the present invention;

[0020] Figure 4 Schematic diagram of the structure of the valve prosthesis in Embodiment 1 of the present invention in a closed state;

[0021] Figure 5 Schematic diagram of the structure of the valve prosthesis in Embodiment 1 of the present invention in an open state;

[0022] Figure 6 Schematic diagram of the suture rod before and after deformation in Embodiment 1 of the present invention

[0023] Figure 7 Schematic diagram of the connection structure of the suture rod with the inflow end and the outflow end in Embodiment 1 of the present invention;

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

[0025] Figure 9 Schematic diagram of the deployment 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 A therein;

[0027] Figure 11 Schematic diagram of the thickness of the filling part in Embodiment 1 of the present invention;

[0028] Figure 12 Schematic diagram of the structure of the stent in Embodiment 2 of the present invention;

[0029] Figure 13 Schematic diagram of the structure of the valve assembly in Embodiment 2 of the present invention;

[0030] Figure 14 Schematic diagram of the structure of the suture rod in Embodiment 2 of the present invention;

[0031] Figure 15 Schematic diagram of the structure of the suture rod from another perspective in Embodiment 2 of the present invention;

[0032] Figure 16 Schematic diagram of the deformation of the deformable arm in Embodiment 2 of the present invention;

[0033] Figure 17 Schematic diagram of the structure 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 B therein;

[0035] Figure 19 Schematic diagram of the structure when the deformable arm and the support arm are in the same plane in Embodiment 2 of the present invention;

[0036] Figure 20 Schematic diagram of the structure of the valve prosthesis in Embodiment 2 of the present invention;

[0037] Figure 21 Schematic diagram of the connection structure of the first suture and the second suture in Embodiment 2 of the present invention. Detailed implementation manners

[0038] To make the above objects, features, and advantages of the present invention more obvious and understandable, the following provides a detailed description of the specific embodiments of the present invention in conjunction with the accompanying drawings. Many specific details are set forth in the following description to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed below.

[0039] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the technical field to which the present invention belongs. The terms used in the description of the present invention herein 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, "distal" is generally defined as the end far from the operator during the surgical procedure, and "proximal" is defined as the end close to the operator during the surgical procedure. A valve prosthesis generally includes an open state and a closed state. When the valve prosthesis is in the open state, blood flow can pass through the valve prosthesis, and when the valve prosthesis is in the closed state, the blood flow is blocked 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] Embodiment 1

[0042] This embodiment provides a valve prosthesis 200 for interventional use at valve positions such as the aortic valve, mitral valve, tricuspid valve, or pulmonary valve to replace the native valve to achieve heart valve replacement. As Figure 2 shown, 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. The seal 220 includes a filling portion 222. The filling portion 222 is arranged along the axial direction of the stent 210, and the filling portion 222 protrudes in the direction towards the outflow end of the stent 210.

[0043] As Figure 3As shown, the stent 210 is adapted to be implanted at the human annulus. The diameter of the stent 210 is greater than the diameter of the human annulus. The stent 210 has a certain elastic deformation property to be in interference fit with the human 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 inflow end 213. The outflow end 211 includes a first corrugated ring 2111 and a second corrugated ring 2112. The first corrugated ring 2111 and the second corrugated ring 2112 are arranged at intervals along the axis of the stent 210. The first corrugated ring 2111 and the second corrugated ring 2112 are connected by a plurality of rod-shaped members, and the plurality of rod-shaped members are arranged at intervals along the circumference of the stent 210. The inflow end 213 includes a third corrugated ring 2131 and a fourth corrugated ring 2132. The third corrugated ring 2131 and the fourth corrugated ring 2132 are arranged at intervals along the axis of the stent 210. The third corrugated ring 2131 and the fourth corrugated ring 2132 are connected by a plurality of rod-shaped members, and the plurality of rod-shaped members are arranged at intervals along the circumference of the stent 210. The main body 212 includes a plurality of suture rods 2121, and the plurality of suture rods 2121 are arranged at intervals along the circumference of the stent 210.

[0044] The leaflet assembly 230 is connected to the inner wall of the main body 212. The leaflet assembly 230 is sutured to the suture rods 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, the blood flow is blocked by the leaflet assembly 230 and cannot pass through the main body 212.

[0045] As Figure 4 shown, the stent 210 further includes a membrane 260. The membrane 260 extends from the inflow end 213 to the main body 212. The seal 220 is sutured to the membrane 260. The connecting end of the leaflet assembly 230 is sutured to the membrane 260. An opening is formed in the membrane 260 and extends from the position where the leaflet assembly 230 is sutured to the membrane 260 towards the inflow end of the stent 210. When the leaflet assembly 230 is in the closed state, the leaflet assembly 230 closes, and the fluid extends from the through portion of the membrane 260 towards the radial sides of the stent 210 to enter the sinus of the aortic valve.

[0046] As Figure 4As shown, the seal 220 is circumferentially arranged along the stent 210. The seal 220 has an annular structure. The seal 220 is sleeved on the side wall of the stent 210 and 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 certain elastic deformation performance. After the valve annulus is implanted, the outer wall of the seal 220 fits with the native valve annulus 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 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 close to the outflow end of the stent 210. The filling portion 222 extends from the inflow end of the stent 210 to the outflow end of the stent 210. The filling portion 222 is arranged in the direction towards the outflow end of the stent 210, and the convex surface of the filling portion 222 faces the outflow end of the stent 210.

[0047] After the valve prosthesis 200 is implanted at the position corresponding to the native valve annulus, the side wall of the stent 210 fits with the native valve annulus and has a certain elastic acting force, realizing the fixation of the valve prosthesis 200. By arranging the seal 220 around the outer wall of the stent 210, the seal 220 can fill the gap between the stent 210 and the native valve annulus. Then, since the seal 220 includes a filling portion 222, and the filling portion 222 protrudes in the direction towards the outflow end of the stent 210, the filling portion 222 can extend into the semi-closed area 110 at the leaflet fusion part after being implanted, so as to squeeze out the blood in the semi-closed area 110 and prevent the blood from staying in the semi-closed area 110 to form thrombus.

[0048] As Figure 2 , Figure 3 shown, the stent 210 includes suture rods 2121. The suture rods 2121 are arranged along the axial direction of the stent 210. A plurality of suture rods 2121 are arranged at intervals along the circumferential direction of the stent 210. The leaflet assembly 230 is located inside the stent 210 and is connected to the suture rods 2121. The filling portion 222 is connected to the suture rods 2121.

[0049] Both ends of the suture rod 2121 are respectively connected to the outflow end portion 211 and the inflow end portion 213 of the stent 210. The suture rod 2121 is arranged along the axial direction of the stent 210. There are multiple suture rods 2121. The multiple suture rods 2121 are arranged at intervals along the circumferential direction of the stent 210. The multiple suture rods 2121 enclose to form the main body portion 212. The leaflet assembly 230 is located inside the main body portion 212. The leaflet assembly 230 is sutured and connected to the side wall of the suture rod 2121. The filling portion 222 is sutured and connected to the suture rod 2121. One end of the filling portion 222 close to the outflow end of the stent 210 is connected to the suture rod 2121.

[0050] As Figure 4 shown, during the process of the leaflet assembly 230 switching from the closed state to the open state, the heart is in the systolic state. The free end of the leaflet moves in a direction away from the center of the main body 212 under the pressure of the heart chamber, and the leaflet pulls the suture rod 2121 to move in a direction away from the center of the stent 210. The suture rod 2121 moves in a direction away from the center of the stent 210 under the pulling action of the leaflet to reset. The filling part 222 follows the movement of the suture rod 2121 to reset. 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 Figure 5 shown, during the process of the leaflet assembly 230 switching from the open state to the closed state, the heart is in the diastolic state. The free end 233 of the leaflet assembly 230 moves in a direction close to the center of the main body 212, and the leaflet assembly 230 pulls the suture rod 2121 to move in a direction close to the center of the stent 210. The suture rod 2121 is inclined in a direction close to the center of the stent 210 under the pulling action of the leaflet. The angle between the suture rod 2121 and the axis of the stent 210 is a2. The filling part 222 moves in a direction close to the outflow end under the action of the deformed pull of the suture rod 2121. The vertical distance between the filling part 222 and the inflow end of the stent 210 is d2, and the filling part 222 squeezes the native leaflet fusion tissue in the semi-closed area 110. Among them, the distance d2 is greater than the distance d1. The angle a1 < the angle a2.

[0052] As Figure 6 shown, Figure 6 is a schematic diagram of the suture rod 2121 before and after deformation. Among them, the dotted line is the schematic diagram of 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] In this way, by including the suture rod 2121 in the stent 210, the suture rod 2121 is arranged along the axial direction of the stent 210, and the leaflet assembly 230 is located inside the stent 210 and connected to the suture rod 2121, so that the opening and closing of the leaflet assembly 230 can pull the suture rod 2121 to move in a direction close to the center of the stent 210, or drive the suture rod 2121 to move in a direction away from the center of the stent 210. Then, by connecting the filling part 222 with the suture rod 2121, the filling part 222 can move in the direction of the outflow end 241 following the movement of the suture rod 2121. Furthermore, the proximal side part of the filling part 222 can squeeze the semi-closed area 110 during the closing process of the leaflet assembly 230, thereby facilitating the extrusion of the accumulated blood flow in the semi-closed area 110 and preventing the formation of thrombus 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. Both 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 at a position close to the outflow end portion 211. The leaflet assembly 230 is sutured or adhered to the support section 2123, and the filling part 222 is sutured or adhered 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 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 ratio of the first section 2122, the support section 2123 and the second section 2124 is x:y:z. The ratio of the length from the first section 2122 to the midpoint of the support section 2123 to the total length of the suture rod 2121 is: x + y / 2. The ratio of the length from the second section 2124 to the midpoint of the support section 2123 to the total length of the suture rod 2121 is: z + y / 2. 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 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 to the support section 2123, the connection between the leaflet assembly 230 and the suture rod 2121 is achieved. Further, since the support section 2123 is located at a 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, with the support section 2123 and the filling part 222 respectively located on both sides of the midpoint of the axis of the suture rod 2121, the position of the maximum deformation amount of the suture rod 2121 under the traction of the leaflets is at the position of the suture rod 2121 close to the inflow end 242. Thus, it is convenient for the suture rod 2121 to drive the filling part 222 into the semi-closed area 110 after deformation.

[0058] As Figures 4 to 6 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 the first position. When the leaflet assembly 230 is in the closed state, the filling part 222 is in the second position, and the second position is on the side closer to the outflow end 241 than the first position.

[0059] When the leaflet assembly 230 is in the open state, the free ends of the leaflets are arranged close to the inner wall of the stent 210. The acting 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 distance from the distal end (i.e., the end close to the outflow end 241) of the filling part 222 to 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 are in contact with each other, and the connecting ends of the leaflets pull the suture rod 2121 to move in the direction close to the center of the stent 210. The support section of the suture rod 2121 is pulled by the leaflets and moves in the direction close to the center of the stent 210. The suture rod 2121 is axially inclined relative to the stent 210, and the distal end of the filling part 222 follows the inclination 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 direction of the outflow end 241 when in the second position.

[0060] It should be noted that in the heart chamber, when the leaflet assembly 230 is in the open state, the pressure of the heart chamber towards the outflow end of the stent 210 is usually small, while when the leaflet assembly 230 is in the closed state, the pressure between the heart chamber and the leaflet assembly 230 is usually high. During the process of heart contraction and relaxation, especially when the leaflet assembly 230 is in the closed state, the pressure of the heart pumping blood on the leaflet assembly 230 is large. At this time, the leaflets are under the action of the heart pressure and form a pulling force that drives the suture rod 2121 towards the center side of the stent 210.

[0061] In this way, when the leaflet assembly 230 is in the open state, the distal end of the filling portion 222 is in the first position, and when the leaflet assembly 230 is in the closed state, the distal end of the filling portion 222 is in the second position. The second position is located on the side of the first position closer to the outflow end 241 of the stent 210, so that the opening and closing of the leaflet assembly 230 can drive the corresponding movement of the filling portion 222, thereby enabling the leaflet to drive the filling portion 222 to squeeze the fusion part of the native leaflet, facilitating the filling portion 222 to squeeze the semi-closed region 110.

[0062] As Figure 7 shown, at least a part of the support segment 2123 protrudes towards the radially outer side of the stent 210. Correspondingly, the part of the suture rod 2121 corresponding to the filling portion 222 also inclines towards the radially outer side of the stent 210.

[0063] In the axial cross-section of the valve prosthesis 200, the inner edge of the support segment 2123 is located radially outside the outflow end portion 211 or the inflow end portion 213. The second segment 2124 of the suture rod 2121 is connected to the support segment 2123. The second segment 2124 is inclined with respect to the axis of the stent 210. The end of the second segment 2124 close to the support segment 2123 is located radially outside the outflow end portion 211 or the inflow end portion 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 portion 222 is connected to the second segment 2124, and the filling portion 222 is also inclined with respect to the axis of the stent 210. The angle between the filling portion 222 and the axis of the stent 210 is between 10° and 45°. Specifically, the angle between the filling portion 222 and the axis of the stent 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 section 2124 is in a state where it is not pulled by the leaflet assembly 230. The acting force between the suture rod 2121 and the leaflet assembly 230 is small. The second section 2124 is inclined relative to the axis of the stent 210, and the included angle between the second section 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 section 2124 is in a state where it is pulled by the leaflet assembly 230. The acting 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 part of the support section 2123 protruding 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 side 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 rod width of the part where the suture rod 2121 is connected to the filling part 222 is smaller than the rod width of the support section 2123. The rod diameters of the first section 2122 and the second section 2124 of the suture rod 2121 are smaller than the rod diameter of the support section 2123. The rod diameter of the first section 2122 is between 0.7 - 1.3 mm. Specifically, the rod diameter of the first section 2122 is 0.7 mm, 0.9 mm, 1.1 mm, or 1.3 mm. The rod diameter of the second section 2124 is between 0.7 - 1.3 mm. Specifically, the rod diameter of the first section 2122 is 0.7 mm, 0.9 mm, 1.1 mm, or 1.3 mm. The rod diameter of the support section 2123 is between 1.0 - 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, since the rod widths of the first section 2122 and the second section 2124 of the suture rod 2121 are smaller than the rod 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 part of the filling part 222 (i.e., the part close to the inflow end 242) into the semi - closed area 110.

[0067] As Figure 7 , Figure 8 shown, the valve prosthesis 200 further 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 to connect 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. The suture hole 2125 is arranged along the axial direction of the stent 210. At least part of the leaflet assembly 230 is located within the suture hole 2125. The 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 winds around the support section 2123 for multiple turns and then knots and fixes, thereby realizing 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 bypasses the filling part 222 and is sutured and connected to the filling part 222. The first suture 251 and the second suture 252 can be surgical suture, PTFE wire, or PET wire.

[0069] In this way, during the opening and closing process 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 towards the inner side of the stent 210 to form a guiding surface. The leaflet assembly 230 pulls the filling part 222 towards the radially inner side of the stent 210 through the second suture 252. The filling part 222 moves towards the outflow end direction of the stent 210 under the guiding action of the guiding surface, so that the filling part 222 can further enter the native leaflet fusion region, and can further fill the semi-closed region 110 when there is still a gap between the seal 220 and the native leaflet fusion region.

[0070] As Figure 9 shown, the leaflet assembly 230 includes a plurality of leaflets 231. Two adjacent leaflets 231 at least partially overlap in the circumferential direction to form an overlapping part 234. At least part of the overlapping part 234 is received in the suture hole 2125, and the second suture 252 is connected to the overlapping part 234.

[0071] The leaflet assembly 230 includes a plurality of leaflets 231. The 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 part 212 or the suture rod 2121. The free end 233 can move towards the direction close to the center of the main body part 212 or towards the direction away from the center of the main body part 212 under the influence of the pressure of the heart. In the deployment schematic diagram of the leaflet assembly 230, the leaflet assembly 230 includes a plurality of leaflets 231. The leaflet 231 includes a free end 233 and a connecting end 232. The connecting ends 232 of all the leaflets 231 are connected end to end in sequence to form an annular structure. The connecting ends 232 of all the leaflets 231 are connected to the inner wall of the stent 210. The free end 233 of the leaflet 231 can move inside the stent 210 to realize the opening or closing of the leaflet assembly 230. The leaflet 231 further includes an overlapping part 234. The overlapping part 234 is arranged along the circumference of the stent 210. The overlapping parts 234 of two adjacent leaflets 231 overlap in the circumferential direction. The overlapping part 234 is located in the suture hole 2125. The overlapping part 234 is connected to the first suture 251, and the first suture 251 sutures the overlapping part 234 in the suture hole 2125. One end of the second suture 252 is sutured on the overlapping part 234, and the other end of the second suture 252 is sutured on the filling part 222.

[0072] In this way, by the overlapping part 234 of the leaflet 231 being located in the suture hole 2125, the stress-bearing area of the leaflet 231 located in the suture hole 2125 is increased. By both the first suture 251 and the second suture 252 being connected to the overlapping part 234, the maximum position of the pulling force of the leaflet 231 is located at the overlapping part 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 part 222.

[0073] As Figure 10 , Figure 11 shown, the seal 220 includes a sealing portion 221, the sealing portion 221 is sleeved on the side wall of the stent 210, the filling portion 222 is connected to the sealing portion 221, the filling portion 222 is located on one side of the sealing portion 221 close to the outflow end, and the thickness of the filling portion 222 is the same as that of the sealing portion 221.

[0074] The sealing portion 221 is disposed around the side wall of the stent 210, and through holes are formed in the sealing portion 221, the through holes penetrate through the axial two ends of the sealing portion 221, and the inner wall of the through holes is attached to the outer wall of the stent 210. The sealing portion 221 can be sewn or bonded to the side wall of the stent 210. The outer wall of the sealing portion 221 is adapted to be attached to the native annulus tissue. The filling portion 222 is connected to the axial end face of the sealing portion 221, the filling portion 222 is located on one side of the sealing peak portion close to the outflow end, and the filling portion 222 can be integrally connected, sewn or bonded to the sealing portion 221. As Figure 11 shown, the thickness of the filling portion 222 refers to the distance t1 between the inner edge and the outer edge 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 is attached to the stent 210, and the outer edge of the filling portion 222 in the radial direction of the stent 210 is adapted to be attached to the annulus tissue. As Figure 10 shown, the thickness of the sealing portion 221 refers to the distance t2 between the inner edge and the outer edge of the sealing portion 221 in the radial direction of the stent 210. The radial inner edge of the sealing portion 221 is attached to the stent 210, and the radial outer edge of the sealing portion 221 is adapted to be attached to the 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, and a part of the annular member is bent and gathered toward the outflow end direction to form the filling portion 222, and the remaining part 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 on the axial end face of the sealing portion 221.

[0076] In this way, since the filling portion 222 is located on one side of the sealing portion 221 close to the outflow end, the filling portion 222 can fill the semi-closed area 110 between the sealing portion 221 and the hardened tissue, avoiding the accumulation of the refluxed blood to form thrombus in the semi-closed area 110. Since the thickness of the filling portion 222 is the same as that of the sealing portion 221, the outer edge of the sealing portion 221 and the outer edge of the filling portion 222 are located in the same circumferential plane, thereby increasing the abutting stability between the seal 220 and the native annulus.

[0077] Embodiment 2

[0078] AsFigure 12 As shown, the difference between this embodiment and the first embodiment 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 portion 312. The two ends of the main body portion 312 are respectively connected to the outflow end 311 and the inflow end 313. The maximum circumference of the main body portion 312 is greater than the maximum circumference of the outflow end 311 or the maximum circumference of the inflow end 313. It further includes a leaflet assembly 330, and the leaflet assembly 330 is connected to the inner wall of the main body portion 312. The maximum circumference of the leaflet assembly 330 is greater than the maximum circumferences of the outflow end 311 and the inflow end 313.

[0079] The main body portion 312 has a tubular structure. The circumferential side wall of the main body portion 312 bulges toward the radially outer side. The maximum diameter of the main body portion 312 is greater than the maximum diameter of the outflow end 311 or the maximum diameter of the inflow end 313. At the location where the diameter of the main body portion 312 is the largest, the circumference of the main body portion 312 is the maximum circumference of the tubular structure. The main body portion 312 can be formed by laser cutting a tubular member into a mesh structure and then thermally shaping it, or can be formed by braiding a braided wire material, or can also be formed by circumferentially arranging a plurality of rod-shaped members.

[0080] The outflow end 311 of the stent 310 has an annular structure. The diameter of the outflow end 311 of the stent 310 is d1, and the circumference of the outflow end 311 of the stent 310 is c1. The inflow end 313 of the stent 310 has an annular structure. The diameter of the inflow end 313 of the stent 310 is d2, and the circumference of the inflow end 313 of the stent 310 is c2. The support section 3124 of the stent 310 is located on the main body portion 312. The diameter of the main body portion 312 increases from both ends of the main body portion 312 toward 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 portion 312. Among them, d3 > d1, and d3 > d2. c3 > c1, and c3 > c2.

[0081] The leaflet assembly 330 is sutured to the support section 3124. As Figure 13 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 location of the maximum circumference of the support section 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 flow passes through the leaflet assembly 330 and enters the heart. When the leaflet assembly 330 is in the closed state, the leaflet assembly 330 forms a seal inside the stent 310, and it is difficult for the blood flow on both sides of the leaflet assembly 330 to pass through the inside of the stent 310.

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

[0083] As Figure 12 shown, the main body portion 312 includes a suture rod 3121 which protrudes towards the radially outer side. The suture rod 3121 is at least partially located radially outside the outflow end portion 311 or the inflow end portion 313. At least part of the leaflet assembly 330 is sutured to the suture rod 3121, and at least part of the leaflet assembly 330 is located radially outside the outflow end portion 311.

[0084] One end of the suture rod 3121 is connected to the outflow end portion 311 of the stent 310, and the other end of the suture rod 3121 is connected to the inflow end portion 313 of the stent 310. A plurality of suture rods 3121 are arranged in a circumferential array along the main body portion 312, and adjacent two suture rods 3121 are spaced apart. All the suture rods 3121 enclose to form the main body portion 312. As Figure 14 、 Figure 15 shown, the suture rod 3121 includes a support section 3124 which protrudes towards the radially outer side of the stent 310. The convex surface of the support section 3124 faces the radially outer side of the stent 310, and the convex surface of the support section 3124 has an arc-shaped structure. The concave surface of the support section 3124 faces the radially inner side of the stent 310, and the concave surface of the support section 3124 has an arc-shaped structure. The inner wall of the support section 3124 is located radially outside the outflow end portion 311, and the inner wall of the support section 3124 is located radially outside the inflow end portion 313. The overlapping portion 334 of the leaflet assembly 330 is sutured inside the support section 3124.

[0085] Thus, by making the suture rod 3121 protrude towards the radially outer side of the stent 310 and the suture rod 3121 being at least partially located radially outside the outflow end portion 311 or the inflow end portion 313, at least part of the side wall of the main body portion 312 is located radially outside the outflow end portion 311 or the inflow end portion 313. By suturing the leaflet assembly 330 to the side wall of the suture rod 3121 which is located radially outside the outflow end portion 311 or the inflow end portion 313, the maximum perimeter of the leaflet assembly 330 is greater than the maximum perimeter of the outflow end portion 311 or the inflow end portion 313.

[0086] As Figure 14 、 Figure 15As shown, the suture rod 3121 includes a support arm 3123 and a deformation arm 3124. 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 deformation arm 3124 is located radially inside the support arm 3123. The deformation arm 3124 is connected to the support arm 3123. The stiffness of the deformation arm 3124 is less than that of the support arm 3123. The leaflet assembly 330 is connected to the deformation arm 3124.

[0087] Two ends of the deformation arm 3124 are connected to the support arm 3123. The deformation arm 3124 is located radially inside the support arm 3123. The inner wall of the support arm 3123 and the outer wall of the deformation arm 3124 are arranged at intervals, and there is a certain distance between the inner wall of the support arm 3123 and the outer wall of the deformation arm 3124. Both the support arm 3123 and the deformation arm 3124 are in an arc structure. The convex surface of the support arm 3123 faces the radially outer side of the bracket 310, and the concave surface of the support arm 3123 faces the radially inner side of the bracket 310. The convex surface of the deformation arm 3124 faces the radially outer side of the bracket 310, and the concave surface of the deformation arm 3124 faces the radially inner side of the bracket 310.

[0088] The deformation arm 3124 includes a first end 3124a and a second end 3124b. Both the first end 3124a and the second end 3124b are connected to the support arm 3123. The first end 3124a of the deformation arm 3124 is close to the outflow end, and the second end 3124b of the deformation arm 3124 is close to the inflow end. The first end 3124a is arranged at intervals from the outflow end 311 of the bracket 310, and the second end 3124b is arranged at intervals from the inflow end 313 of the bracket 310. The support arm 3123 includes a first barrier section 3123a and a second barrier section 3123b. The first barrier section 3123a is located between the first end 3124a of the deformation arm 3124 and the outflow end 311 of the bracket 310. Two ends of the first barrier end are respectively connected to the first end 3124a of the deformation arm 3124 and the outflow end 311 of the bracket 310. The second barrier section 3123b is located between the second end 3124b of the deformation arm 3124 and the outflow end 311 of the bracket 310. Two ends of the second barrier section 3123b are respectively connected to the second end 3124b of the deformation arm 3124 and the inflow end 313 of the bracket 310. The stiffness of the first barrier section 3123a is greater than that of the deformation arm 3124. The stiffness of the second barrier section 3123b is greater than that of the deformation arm 3124. The first barrier section 3123a and the second barrier section 3123b are used to form a deformation barrier between the deformation arm 3124 and the outflow end 311 or the inflow end 313 of the bracket 310, so as to prevent the deformation of the deformation arm 3124 from driving the outflow end 311 or the inflow end 313 of the bracket 310 to move towards the axial center of the bracket 310.

[0089] The rigidity of the deformable arm 3124 is smaller than the rigidity of the support arm 3123. It should be noted that rigidity refers to the performance of a material or structure in resisting elastic deformation when subjected to force. The greater the rigidity, the more difficult it is for the material or structure to deform, and the smaller the rigidity, the easier it is for the material or structure to deform. The rod width of the deformable arm 3124 is smaller than the rod width of the support arm 3123, so that the rigidity of the deformable arm 3124 is smaller than the rigidity of the support arm 3123. It is understood that in some other embodiments, the deformable arm 3124 is a bent structure, and the support arm 3123 is a straight structure.

[0090] like Figure 16 As shown, Figure 16 The deformation arm 3124 shown by the middle dotted line is a schematic diagram of the deformation arm 3124 after being pulled and deformed; in the process of switching the leaflet assembly 330 from the open state to the closed state, under the pressure of the heart chamber, the free end 333 of the leaflet 331 moves toward the radial center of the support 310, the leaflet 331 pulls the deformation arm 3124, the deformation arm 3124 deforms toward the radial inner side of the support 310, and the shape of the support arm 3123 remains unchanged or the deformation amount is less than the deformation amount of the deformation arm 3124. In the process of switching the leaflet assembly 330 from the closed state to the open state, the leaflet assembly 330 is opened under the pressure of the heart chamber, the free end 333 of the leaflet 331 moves toward the radial outer side of the support 310, the deformation arm 3124 rebounds to the state before deformation, and the shape of the support arm 3123 remains unchanged or the deformation amount is less than the deformation amount of the deformation arm 3124.

[0091] In this way, the suture rod 3121 includes a support arm 3123 and a deformation arm 3124. 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. The deformation arm 3124 is 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 bracket 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 bracket 310. The deformation arm 3124 drives the leaflet 331 to move toward the radial outer side of the bracket 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 by the traction of the leaflet assembly 330 and causing the stent 310 to shorten.

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

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

[0094] As Figure 18 shown, the bent section 3124 includes a first bent section 3124c, a second bent section 3124d and a third bent section 3124e. Both ends of the first bent section 3124c are respectively connected to the support arm 3123 and the second bent section 3124d. Both ends of the second bent section 3124d are respectively connected to the first bent section 3124c and the third bent section 3124e. Both ends of the third bent section 3124e are respectively connected to the second bent section 3124d and the support arm 3123. The first bent section 3124c and the second bent section 3124d are arranged at a predetermined angle. The angle between the first bent section 3124c and the second bent section 3124d is between 15° and 60°. Specifically, it can be 15°, 30°, 45° or 60°. The opening of the angle between the first bent section 3124c and the second bent section 3124d is arranged along the circumferential direction of the bracket 310. The second bent section 3124d and the third bent section 3124e are arranged at a predetermined angle. The angle between the second bent section 3124d and the third bent section 3124e is between 15° and 60°. Specifically, it can be 15°, 30°, 45° or 60°. The opening of the angle between the second bent section 3124d and the third bent section 3124e is arranged along the circumferential direction of the bracket 310. The opening direction of the angle between the second bent section 3124d and the third bent section 3124e is opposite to the opening orientation of the angle between the first bent section 3124c and the second bent section 3124d. In some other embodiments, the opening of the angle between the first bent section 3124c and the second bent section 3124d can also be arranged along the radial direction of the bracket 310.

[0095] During the process that the deformable arm 3124 is pulled by the leaflet 331 and deformed towards the radially inner side of the stent 310, the angle between the first bending section 3124c and the second bending section 3124d increases, the angle between the second bending section 3124d and the third bending section 3124e increases, and the supporting section 3125 moves towards the radially inner side of the stent 310. After the pulling force applied to the deformable arm 3124 is eliminated, the angle between the first bending section 3124c and the second bending section 3124d decreases, the angle between the second bending section 3124d and the third bending section 3124e decreases, and the supporting section 3125 is pulled by the bending section 3124 and returns to its original position.

[0096] In this way, by connecting the two ends of the supporting 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 amount of deformation allowance for the movement of the supporting section 3125, preventing the deformable arm 3124 from deforming and pulling the outflow end 311 and the inflow end 313 of the stent 310 towards the axial center of the stent 310.

[0097] As Figure 17 shown, the suture holes are formed in the supporting section 3125. The leaflet assembly 330 includes a plurality of leaflets 331. The plurality of leaflets 331 at least partially overlap in the circumferential direction to form an overlapping portion 334. The overlapping portion 334 of the valve is located within the suture holes and is connected to the supporting section 3125. The suture holes are formed in the supporting section 3125 and are arranged along the axial direction of the stent 310. The contour of the suture holes corresponds to the contour of the overlapping portion 334 of the valve. The overlapping portion 334 of the leaflet 331 is received within the suture holes, and the overlapping portion 334 of the valve is sutured and connected to the suture holes. The stiffness of the supporting section 3125 is greater than that of the bending section, the thickness of the supporting section 3125 is greater than that of the bending section, and the rod width of the supporting section 3125 is greater than that of the bending section.

[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 adjacent first and second leaflets. The overlapping portion 334 of the first leaflet is inserted into the first suture hole 3125a and partially located radially outside the first suture hole 3125a. The overlapping portion 334 of the second leaflet is inserted into the second suture hole 3125b and 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 in contact with each other on the radial two sides of the first suture hole 3125a and the second suture hole 3125b. The overlapping portion 334 of the first leaflet and the overlapping portion 334 of the second leaflet are sutured on the radial two 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 line 351 bypasses the side wall of the support section 3125 to connect the overlapping portions 334 of the first and second leaflets, so that the support section 3125 and the first leaflet 331 and the second leaflet 331 are stressed as a whole. Thus, during the process of the leaflet assembly 330 pulling the support section 3125 to move, the contact area between the overlapping portion 334 of the leaflet assembly 330 and the deformation arm 3124 is increased through the support section 3125, so that the stress concentration between the overlapping portion 334 of the leaflet assembly 330 and the support section 3125 can be reduced, and the fatigue resistance during the opening and closing process of the leaflet assembly 330 can be improved. It can be understood that in other embodiments, an oval hole or a strip hole can also be provided on the support section 3125.

[0099] In this way, during the process of the leaflet assembly 330 driving the deformation arm 3124 to deform, since the deformation 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, and the overlapping portion 334 of the leaflet assembly 330 is sutured in the suture hole, the deformation of the deformation arm 3124 is concentrated on the bending section 3124, while the support section 3125 maintains its shape basically unchanged, so that the possibility of the support section 3125 deforming and rubbing against the overlapping portion 334 of the leaflet 331 or puncturing the leaflet 331 to damage the leaflet 331 can be reduced.

[0100] Such as Figure 19As shown, both ends of the deformable arm 3124 are connected to the support arm 3123. The center line l1 of the support arm 3123 and the center line l2 of the deformable arm 3124 are located on the same axial plane p1 of the bracket 310. The axial plane p1 passes through the radial center of the bracket 310. The center line of the deformable arm 3124 refers to the connecting line l1 of the midpoints at both ends of the deformable arm 3124, and the center line of the support arm 3123 refers to the connecting line l2 of the midpoints at both 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, as Figure 20 shown, the bracket 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 at intervals along the circumferential direction of the bracket 310. The first suture rod 3141 includes a first deformable arm 3124 and a first support arm 3123. The first deformable arm 3124 and the first support arm 3123 are located on the 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. The second deformable arm 3124 and the second support arm 3123 are located on the 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. The third deformable arm 3124 and the third support arm 3123 are located on the axial plane s3 (not shown in the figure). 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, since the center line of the support arm 3123 and the center line of 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 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 side tilt or torsion of the bracket 310 driven by the deformation of the deformable arm 3124.

[0103] As Figure 20 、 Figure 21As shown, the seal 320 includes a sealing portion 321 and a filling portion 322. The sealing portion 321 is sleeved on the inflow end portion 313 of the bracket 310. The filling portion 322 is connected to one axial end of the sealing portion 321. The filling portion 322 is located on the side of the sealing portion 321 close to the inflow end. The filling portion 322 is attached to the outer arm of the support arm 3123. The outer wall of the support arm 3123 is axially inclined relative to the bracket 310. The outer wall of the support arm 3123 is inclined towards the radial outside of the bracket 310. The outer wall of the support arm 3123 forms a guiding surface for the movement of the filling portion 322. The filling portion 322 is at least partially attached to the outer wall of the support arm 3123.

[0104] As Figure 21 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. The other end of the second suture 352 bypasses the support arm 3123 and is connected to the filling portion 322. There is a certain tension between the second suture 352 and the filling portion 322. 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 portion. The filling portion 322 is not directly connected to the outflow end portion 311 or the support arm 3123. After the filling portion 322 is subjected to the pulling force of the second suture 352, the filling portion 322 can deform towards the inflow end of the bracket 310.

[0105] During the process of the valve leaf assembly 330 switching from the open state to the closed state, the valve leaf assembly 330 drives the deformation arm 3124 to move towards the radial inner direction of the bracket 310. The deformation arm 3124 pulls the filling portion 322 to deform towards the outflow end portion 311 of the bracket 310 through the second suture 352. Under the guiding action of the outer side of the support arm 3123, the filling portion 322 moves towards the radial outer side and the inflow end direction of the bracket 310, so that the filling portion 322 can further enter the fusion area of the native valve leaf 331. When there is still a gap between the main body portion 312 of the seal 320 and the fusion area of the native valve leaf 331, the semi-closed area 110 can be further filled.

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

[0107] The above-described embodiments merely represent several implementation manners of the present invention. The description thereof is relatively specific and detailed, but it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all fall within the protection scope of the present invention. Therefore, the protection scope of the present invention patent shall be subject to the appended claims.

Claims

1. A valve prosthesis, characterized in that, It includes an inflow end, an outflow end, and a main body. The two ends of the main body are respectively connected to the inflow end and the outflow end. 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. It further includes a leaflet assembly, and the leaflet assembly is connected to the inner wall of the main body. 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.

2. The valve prosthesis according to claim 1, characterized in that, The main body includes a suture rod, and the suture rod protrudes towards the radially outer side. The suture rod is at least partially located radially outside the inflow end or the outflow end, and the leaflet assembly is connected to the suture rod.

3. The valve prosthesis according to claim 2, wherein The suture rod includes a connected support arm and a deformation arm. The deformation arm is located radially inside the support arm, and the stiffness of the deformation arm is less than the stiffness of the support arm. The leaflet assembly is connected to the deformation arm.

4. The valve prosthesis according to claim 3, wherein Suture holes are formed in the deformation arm. The leaflet assembly includes a plurality of leaflets. Adjacent two leaflets at least partially overlap in the circumferential direction. The overlapping part of the leaflets is located in the suture holes and is connected to the deformation arm.

5. The valve prosthesis according to claim 3, characterized in that, The two ends of the support arm and the two ends of the deformation arm are respectively connected. The center line of the support arm and the center line of the deformation arm are located in the same axial plane, and the axial plane radially passes through the radial center of the main body.

6. The valve prosthesis according to claim 3, wherein, The deformation arm includes a support section and bending sections located at both ends of the support section. The bending sections are connected to the support arm, and the leaflet assembly is connected to the support section.

7. The valve prosthesis according to claim 2, wherein A plurality of the suture rods are arranged at intervals along the circumferential direction of the main body.

8. The valve prosthesis according to any one of claims 1-7, characterized in that, It further includes a seal. The seal is sleeved on the inflow end. The seal at least partially overlaps with the leaflet assembly in the axial direction. The seal includes a filling part, and the filling part protrudes towards the outflow end.

9. The valve prosthesis according to claim 8, wherein It further includes a film. The film covers the side wall of the inflow end, and the film extends from the inflow end to the seal.

10. The valve prosthesis according to claim 8, characterized in that, It further includes a suture. One end of the suture is connected to the filling part, and the other end of the suture is connected to the deformation arm.

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