Valve prosthesis

Abstract

The invention discloses a valve prosthesis which comprises an inflow end and an outflow end, the valve prosthesis comprises a support, a sealing piece and a covering film, the covering film at least covers the part, close to the inflow end, of the support, the sealing piece comprises a sealing material, a first fixing piece and a second fixing piece, and the sealing material comprises a first edge and a second edge which are oppositely arranged; the first edge or an area near the first edge is fixed with the covering film through the first fixing piece, then the second edge is close to the first edge in a rolling or folding mode to form an annular structure arranged on the outer side of the covering film, and then the annular structure and the covering film are fixed through the second fixing piece, so that the sealing piece which is accurately positioned and shaped on the valve prosthesis support can be obtained. Therefore, the perivalvular leakage prevention device can better adapt to the in-vivo physiological environment, and the perivalvular leakage situation is greatly reduced.

Description

Technical Field

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

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

[0003] When the native heart valve becomes narrow, or the native valve leaks or refluxes (such as leaflet calcification), heart valve replacement can be performed. In one treatment option, the native valve can be removed and replaced with a biological valve or a mechanical valve. In order to prevent the biological valve or mechanical valve from causing paravalvular leakage in the body, the outer surface of the biological valve or mechanical valve is provided with a circle of sealing ring in the prior art. The sealing ring can seal the gap between the biological valve or mechanical valve and the valve ring to prevent blood leakage. However, the sealing ring has a certain thickness and is not easy to accurately position at a specific position in the biological valve or mechanical valve. Summary of the Invention

[0004] Based on this, it is necessary to provide a valve prosthesis, which includes a stent, a seal and a coating, the coating at least covering the part of the stent close to the inflow end, the seal including a piece of sealing material, a first fixing member and a second fixing member, the sealing material including a first edge and a second edge arranged opposite to each other, the first edge or the vicinity of the first edge and the side of the coating close to the outflow end are fixed with the first fixing member, and then the second edge is brought close to the first edge by rolling or folding to form an annular structure arranged on the outside of the coating, and then the annular structure is fixed to the coating with the second fixing member.

[0005] Compared with the prior art, the beneficial effects of the above valve prosthesis are:

[0006] The above-mentioned valve prosthesis is provided with a sealing member including a sealing material, a first fixing member and a second fixing member. The first side or the vicinity of the first side is fixed to the side of the membrane close to the outflow end by the first fixing member to achieve preliminary positioning; then the second side is brought close to the first side by rolling or folding to form an annular structure arranged on the outside of the membrane. In this process, there is a relatively flexible adjustment space, so that the seal can be more conveniently and accurately positioned on the bracket, and the seal can also be more conveniently and accurately shaped; finally, the annular structure is fixed to the membrane by the second fixing member to achieve the final fixation, thereby obtaining a seal that is accurately positioned and shaped on the valve prosthesis bracket, so that it can better adapt to the physiological environment in the body to greatly reduce the occurrence of paravalvular leakage. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments recorded in this application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0008] Figure 1 is a schematic structural diagram of a valve prosthesis in one embodiment of the present invention;

[0009] Figure 2 Schematic diagram of the structure of the cooperation between the stent, the expanded sealing material, and the expanded covering film in one embodiment of the present invention;

[0010] Figure 3 is a schematic structural diagram of a sealing material deployed in one embodiment of the present invention;

[0011] Figure 4 Schematic diagram of the structure of the support, the rolled-up sealing material, and the unfolded covering film in cooperation with each other in one embodiment of the present invention;

[0012] Figure 5 Schematic diagram of the structure of a rolled sealing material in one embodiment of the present invention;

[0013] Figure 6 for Figure 1 A schematic diagram of the structure enlargement at point A;

[0014] Figure 7 A schematic structural diagram of a bracket in one embodiment of the present invention;

[0015] Figure 8 A schematic structural diagram of a coating in one embodiment of the present invention;

[0016] Figure 9 A schematic diagram of the unfolding structure of the coating in one embodiment of the present invention;

[0017] Figure 10 FIG1 is a schematic structural diagram of a valve prosthesis in a closed state according to an embodiment of the present invention;

[0018] Figure 11 is a structural schematic diagram of a valve prosthesis in an open state according to an embodiment of the present invention;

[0019] Figure 12 Schematic diagrams of the suturing rod before and after deformation in one embodiment of the present invention;

[0020] Figure 13 Schematic diagram of the connection structure between the suturing rod and the inflow end and the outflow end in one embodiment of the present invention;

[0021] Figure 14 Schematic diagram of the structure of a valve prosthesis in one embodiment of the present invention. DETAILED DESCRIPTION

[0022] To make the above-mentioned objects, features, and advantages of the present invention more readily apparent, specific embodiments of the present invention are described in detail below with reference to the accompanying drawings. The following description sets forth numerous specific details to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways than those described herein, and those skilled in the art may make similar modifications without departing from the scope of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in this specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0024] In the field of interventional medical devices, the "distal end" is usually defined as the end away from the operator during surgery, and the "proximal end" is defined as the end close to the operator during surgery. Valve prostheses usually include open and closed states. When the valve prosthesis is in the open state, blood flow can pass through the valve prosthesis. When the valve prosthesis is in the closed state, blood flow is blocked by the valve prosthesis. When the valve prosthesis is in the open state, refer to Figure 1 The end where the blood flows into the valve prosthesis is defined as the inflow end 242 , and the end where the blood flows out of the valve prosthesis is defined as the outflow end 241 .

[0025] This embodiment provides a valve prosthesis 200, which is used as an interventional valve or surgical valve in valve positions such as the aortic valve, mitral valve, tricuspid valve or pulmonary valve, to replace the native valve to achieve heart valve replacement. Figure 1 As shown, the valve prosthesis 200 includes a stent 210 , a seal 220 , and a coating 260 . The coating 260 covers at least a portion of the stent 210 near the inflow end 242 .

[0026] See Figures 2 to 6 The sealing member 220 includes a sealing material 2201, a first fixing member 2202 and a second fixing member 2203. The sealing material 2201 includes a first edge 2201a and a second edge 2201b arranged opposite to each other. The first edge 2201a or the area near the first edge 2201a is fixed to the coating 260 by the first fixing member 2202, and then the second edge 2201b is brought close to the first edge 2201a by rolling or folding to form an annular structure 2201c arranged on the outside of the coating 260, and then the annular structure 2201c is fixed to the coating 260 by the second fixing member 2203.

[0027] In one embodiment, the annular structure 2201c can be understood as a closed loop structure or an open loop structure. In one embodiment, the annular structure 2201c can also be a closed loop structure or an open loop structure formed by splicing multiple sections.

[0028] The valve prosthesis 200 is provided with a sealing member 220 including a sealing material 2201, a first fixing member 2202 and a second fixing member 2203. The first edge 2201a or the area near the first edge 2201a is fixed to the membrane 260 by the first fixing member 2202 to achieve preliminary positioning; then the second edge 2201b is brought close to the first edge 2201a by rolling or folding to form an annular structure 2201c arranged on the outside of the membrane 260. In this process, there is a relatively flexible adjustment space, so that the sealing member 220 can be more conveniently and accurately positioned on the stent 210, and the sealing member 220 can also be more conveniently and accurately shaped; finally, the annular structure 2201c is fixed to the membrane 260 by the second fixing member 2203 to achieve final fixation, thereby obtaining a sealing member 220 that is accurately positioned and shaped on the valve prosthesis stent 210, so that it can better adapt to the physiological environment in the body and greatly reduce the occurrence of paravalvular leakage.

[0029] Understandably, during the actual valve prosthesis fabrication process, after the annular structure 2201c is secured to the closure 260 using the second fixing member 2203, the seal 220 of the valve prosthesis is formed. It may be found that the shape and position of the already formed seal 220 still need to be adjusted. Typically, this solution involves detaching the entire seal 220 from the stent 210, adjusting the shape of the annular structure 2201c individually, and finally positioning the annular structure 2201c onto the stent 210. This approach is complex and also subject to significant errors in the positioning and shaping of the seal 220. However, in this embodiment, the second fixing member 2203 can be removed (e.g., cut off), the second edge 2201b is unfolded and exposed, and the second edge 2201b is re-aligned with the first edge 2201b by rolling or folding, forming the annular structure 2201c with the appropriate shape and position outside the closure. The annular structure 2201c is then secured to the closure 260 using the second fixing member 2203. Therefore, the shape and position of the sealing member 220 of this embodiment can be easily adjusted at any time, and the sealing member 220 can be accurately positioned and shaped on the valve prosthesis stent 210.

[0030] In one embodiment, when the first edge 2201a is fixed to the coating 260 by the first fixing member 2202, a first protrusion 2201a1 is formed toward the outflow end 241. Along the first protrusion 2201a1, the second edge 2201b is rolled or folded to approach the first edge 2201a, so that the formed annular structure 2201c has a filling portion 222 protruding toward the outflow end 242.

[0031] In the anatomical structure, near the fusion point of the native leaflets, in order to prevent damage to the blood vessels, the native leaflets at the fusion point of the native leaflets will not be completely removed, so some residual hardened tissue will remain. There is a bulge toward the outflow end between the fusion points of two adjacent native leaflets. At this bulge position, when the leaflets are in the process of closing, blood flow flows back from the outflow end side of the valve prosthesis to the bulge position, causing the blood flow to be retained at the bulge position to form a thrombus accumulation.

[0032] See Figure 4 and Figure 5 , the sealing material 2201 can be made of one or more materials such as bovine pericardium, porcine pericardium, silicone or rubber. The annular structure 2201c formed has a certain elastic deformation performance. After the valve ring is implanted, the outer wall of the annular structure 2201c fits with the native valve ring tissue, and the inner wall of the annular structure 2201c fits with the outer wall of the stent 210. The annular structure 2201c is used to block the gap between the stent 210 and the native valve ring tissue. The annular structure 2201c also includes a sealing portion 221, and a filling portion 222 is connected to the sealing portion 221, and the filling portion 222 is located on the side of the sealing portion 221 close to the outflow end. In this embodiment, the sealing portion 221 is generally curved toward the inflow end for better fitting the native valve ring. Alternatively, see Figure 1 The sealing portion 221 may also be flat as a whole.

[0033] After the valve prosthesis 200 is implanted in the position corresponding to the native valve ring, the annular structure 2201c is arranged around the outer wall of the stent 210, so that the annular structure 2201c can fill the gap between the stent 210 and the native valve ring. The filling part 222 protrudes toward the outflow end, so that the filling part 222 can extend into the raised position between the fusion of the leaflets after implantation, thereby squeezing out the blood in the raised position and preventing blood from being retained in the raised position to form a thrombus.

[0034] See again Figures 2 to 5In one embodiment, the first side 2201a includes a first protrusion 2201a facing the outflow end, and the second side 2201b is disposed parallel to the first side 2201a. It will be appreciated that when the first protrusion 2201a is disposed on the first side 2201a, it is sufficient to simply attach the first protrusion 2201a to the appropriate location on the stent 210 and then directly place the sealing material 2201 around the stent 210. Furthermore, by disposing the second side 2201b parallel to the first side 2201a, the annular structure 2201c formed by rolling or folding the second side 2201b closer to the first side 2201a can have a uniform diameter, ensuring that 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 stability of the seal 220 against the native annulus. In other embodiments, the first protrusion 2201 a is not directly provided on the first edge 2201 a , but the first protrusion 2201 a is formed by fixing the first edge 2201 a to the covering film 260 via the first fixing member 2202 .

[0035] See again Figure 2 and Figure 6 In this embodiment, the first fixing member 2202 can be a first suture 2202a, which is sutured along one side of the membrane 260. The second fixing member 2203 includes a second suture 2203a, which includes multiple loops 2203a1. The multiple loops 2203a1 are wrapped around the surface of the annular structure 2201c to secure the annular structure 2201c. In other embodiments, the first fixing member 2202 and the second fixing member 2203 can also be glue or welding materials. At least one side of the annular structure 2201c near the inflow end 242 overlaps with the membrane 260, ensuring a tight fit between the annular structure 2201c and the membrane 260 without any gap, thereby better blocking backflow of blood and paravalvular leakage.

[0036] like Figure 7As shown, the stent 210 is suitable for implantation in the human valve annulus. The diameter of the stent 210 is larger than the diameter of the human valve annulus. The stent 210 has a certain elastic deformation performance to achieve an interference fit with the human valve annulus. The stent 210 includes an outflow end 211, an inflow end 213 and a main body 212. The main body 212 is located between the outflow end 211 and the inflow end 213. The axial ends of the main body 212 are respectively connected to the outflow end 211 and the main body 212. The outflow end 211 includes a first wavy ring 2111 and a second wavy ring 2112. The first wavy ring 2111 and the second wavy ring 2112 are spaced apart along the axial direction of the stent 210. The first wavy ring 2111 and the second wavy ring 2112 are connected by a plurality of rod-shaped members. The plurality of rod-shaped members are spaced apart along the circumference of the stent 210. The inflow end portion 213 includes a third wavy ring 2131 and a fourth wavy ring 2132, which are spaced apart along the axial direction of the stent 210. The third wavy ring 2131 and the fourth wavy ring 2132 are connected by a plurality of rod-shaped members, which are spaced apart along the circumference of the stent 210. The main body portion 212 includes a plurality of suture rods 2121, which are spaced apart along the circumference of the stent 210.

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

[0038] Combine Figure 1 、 Figure 8 and Figure 9 The coating 260 includes an outer coating 2601 and an inner coating 2602 connected to each other. The inner coating 2602 is disposed on the inner wall of the stent 210 and connected to the leaflet assembly 230, and the outer coating 2601 is disposed on the outer wall of the stent 260. The outer coating 2601 includes a second protrusion 2601a facing the outflow end 241 on one side thereof near the outflow end 241. The second protrusion 2601a is fixed to the first protrusion 2601a via the first fixing member 2202, so that there is no gap between the second protrusion 2601a and the filling portion 222 in the axial direction. Such a setting, on the one hand, increases the length of the outer membrane 2601, improves the sealing performance, and reduces the possibility of paravalvular leakage. On the other hand, it can also make the raised positions between the native leaflet fusion tissues be completely filled with the second raised portion 2601a of the outer membrane 2601 and the filling portion 222 without any gaps, thereby preventing blood from refluxing during the closure of the leaflet assembly 230 and accumulating in the raised positions between the native leaflet fusion tissues, thereby avoiding the formation of blood clots.

[0039] like Figure 1 As shown, the stent 210 includes a suture rod 2121, which is arranged along the axial direction of the stent 210, and multiple suture rods 2121 are arranged at intervals along the circumference of the stent 210. The leaflet assembly 230 is located on the inner side of the stent 210 and is connected to the suture rod 2121, and the filling part 222 is connected to the suture rod 2121.

[0040] The ends of the suture rods 2121 are respectively connected to the outflow end 211 and the inflow end 213 of the stent 210. The suture rods 2121 are arranged axially along the stent 210. There are multiple suture rods 2121, which are spaced apart along the circumference of the stent 210 and together form the main body 212. The leaflet assembly 230 is located inside the main body 212 and is sutured to the sidewalls of the suture rods 2121.

[0041] like Figure 10 As shown, in the process of the leaflet assembly 230 switching from a closed state to an open state, the leaflet assembly 230 includes a plurality of leaflets 2301, the heart is in a contraction state, and the free ends of the leaflets 2301 are subjected to the pressure of the heart chamber and move toward a direction away from the center of the main body 212. The leaflets 2301 pull the suture rod 2121 to move toward a direction away from the center of the stent 210. The suture rod 2121 is pulled by the leaflets 2301 and moves toward a direction away from the center of the stent 210 to be reset. After the reset, the suture rod 2121 is not pulled by the leaflets 2301, and the filling part 222 is reset following the movement of the suture rod 2121. The angle between the suture rod 2121 and the axis of the stent 210 is a1, and the vertical distance between the filling part 222 and the inflow end of the stent 210 is d1.

[0042] like Figure 11 As shown, during the transition of the leaflet assembly 230 from an open state to a closed state, the heart is in diastole, the free ends of the leaflets 2301 move toward the center of the main body 212, and the leaflet assembly 230 pulls the suture rod 2121 toward the center of the stent 210. The suture rod 2121 is pulled by the leaflets, tilting toward the center of the stent 210. The angle between the suture rod 2121 and the axis of the stent 210 is a2. The filling portion 222 is pulled by the deformation of the suture rod 2121, moving toward the outflow end. The vertical distance between the filling portion 222 and the inflow end of the stent 210 is d2, and the filling portion 222 compresses the protrusion between the native leaflet fusion tissue. Distance d2 is greater than distance d1. Angle a1 is less than angle a2.

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

[0044] In this way, the stent 210 includes a suture rod 2121, which is arranged along the axial direction of the stent 210. The leaflet assembly 230 is located on the inner side of the stent 210 and is connected to the suture rod 2121, so that the opening and closing of the leaflet assembly 230 can pull the suture rod 2121 to move toward the center of the stent 210, or drive the suture rod 2121 to move toward the center of the stent 210, and then connect with the suture rod 2121 through the filling part 222, so that the filling part 222 can follow the movement of the suture rod 2121 and move toward the outflow end 241, so that the proximal side part of the filling part 222 can squeeze the raised position between the native leaflet fusion tissue during the closing process of the leaflet assembly 230, thereby facilitating the squeezing out of the accumulated blood flow in the raised position between the native leaflet fusion tissue to prevent thrombus formation in this area.

[0045] like Figure 13 As shown, the suture rod 2121 includes a support segment 2123, which is located at the 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 segment 2123, and the filling part 222 is connected to one end of the suture rod 2121 close to the inflow end 242.

[0046] 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 211 of the bracket 210, and the second section 2124 of the suture rod 2121 is connected to the inflow end 213 of the bracket 210. The support section 2123 is located between the first section 2122 and the second section 2124 and is located close to the outflow end 211. The leaflet assembly 230 is sutured, bonded or laser welded to the support section 2123, and the filling part 222 is sutured, bonded or laser welded to the second section 2124 of the suture rod 2121.

[0047] It should be noted that the support section 2123 being located near the outflow end 211 means that the axial midpoint of the support section 2123 is on the side closer 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 as x:y:z. The ratio of the length from the first section 2122 to the midpoint of the support section 2123 to the total length of the suture rod 2121 is x + y / 2. The ratio of the length from the second section 2124 to the midpoint of the support section 2123 to the total length of the suture rod 2121 is z + y / 2. Among them, 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 from the second section 2124 to the midpoint of the support section 2123 of the suture rod 2121 is greater than the length from the first section 2122 to the midpoint of the support section 2123.

[0048] 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. Then, due to the support section 2123 being located near the outflow end 241 of the suture rod 2121 and the filling part 222 being connected to one 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 axial midpoint of the suture rod 2121, so that 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 near the inflow end 242, which facilitates the suture rod 2121 to drive the filling part 222 into the convex position between the native leaflet fusion tissues after deformation.

[0049] As Figure 13 shown, at least part of the support section 2123 protrudes towards the radial outside of the stent 210. Correspondingly, the corresponding part of the suture rod 2121 and the filling part 222 also inclines towards the radial outside of the stent 210.

[0050] 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 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 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 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°, 2�°, 30° or 45°. The filling portion 222 is connected to the second segment 2124. 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°.

[0051] For example, in one embodiment, when the leaflet assembly 230 is in the open state, the suture rod 2121 has been reset, the second 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 with respect to the axis of the stent 210, the angle between the second segment 2124 and the axis of the stent 210 is a1, the filling portion 222 is inclined with respect to the axis of the stent 210, the angle between the filling portion 222 and the center of the axis of the stent 210 is a1, and the distance between the distal end (i.e., the end close to the outflow end 241) of the filling portion 222 and the center of the axis of the stent 210 is c1. 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 angle between the suture rod 2121 and the axis of the stent 210 is a2, the 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 (i.e., the end close to the outflow end 241) of the filling portion 222 and the center of the axis of the stent 210 is c2. c2 < c1. When the leaflet assembly 230 is in the closed state, the distal end (the end close to the outflow end 241) of the filling portion 222 is closer to the outflow end 241 of the stent 210.

[0052] In this way, the support section 2123 at least partially protrudes toward the radial outside of the stent 210, and the corresponding parts of the suture rod 2121 and the filling part 222 are inclined toward the radial outside of the stent 210. When the suture rod 2121 is not pulled by the leaflet assembly 230, the filling part 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 part 222 follows the suture rod 2121 and moves toward the radial inside of the stent 210. The distal end of the filling part 222 has a larger displacement in the axial direction of the stent 210, thereby facilitating the filling part 222 to squeeze the side wall of the native leaflet fusion area.

[0053] See again Figure 9 In one embodiment, the inner film 2602 includes an inner film connecting portion 2602a and an inner film main body 2602b. The inner film connecting portion 2602a protrudes toward the outflow end and includes a petal angle connecting portion 2602a1 and a transition portion 2602a2 connected to each other. Figure 14 The petal angle connection part 2602a1 is connected to the leaflet assembly 230 and the suture rod 2121. The transition part 2602a2 is used to connect the petal angle connection part 2602a1 and the inner covering body 2602b. The suture rod 2121 is supported on the surface of the transition part 2602a2 and fixed on the transition part 2602a2, so that the transition part 2602a2 remains in an expanded state in the axial direction to avoid wrinkles, thereby preventing blood from gathering in the transition part 2602a2 to form a thrombus.

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

[0055] See again Figure 1 and Figure 7 The inflow end portion 213 of the stent 210 includes a free end 2130 facing the outflow end, and the free end 2130 is adjacent to the leaflet assembly 230. Figure 9 The inner covering 2602 also includes a protective portion 2602c, which is arranged between two adjacent leaflet corner connecting portions 2602a1. One end of the protective portion 2602c is connected to the inner covering body 2602b, and the other end of the protective portion 2602c first extends toward the outflow end 241, then wraps the free end 2130 from the inner surface to the outer surface of the stent 210, and then extends toward the inflow end 242 and is fixed, thereby preventing the free end 2130 of the inflow end 213 of the stent 210 from contacting the leaflet assembly 230, thereby wearing the leaflet assembly 230.

[0056] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0057] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A valve prosthesis comprising an inflow end and an outflow end, characterized in that: The valve prosthesis includes a stent, a seal and a coating, the coating at least covers the part of the stent close to the inflow end, the seal includes a sealing material, a first fixing member and a second fixing member, the sealing material includes a first edge and a second edge arranged opposite to each other, the first edge or the area near the first edge is fixed to the coating by the first fixing member, and then the second edge is brought close to the first edge by rolling or folding to form an annular structure arranged on the outside of the coating, and then the annular structure is fixed to the coating by the second fixing member.

2. The valve prosthesis according to claim 1, characterized in that When the first edge is fixed to the coating by the first fixing member, a first protrusion is formed toward the outflow end. Along the first protrusion, the second edge is brought closer to the first edge by rolling or folding, so that the formed annular structure has a filling portion protruding toward the outflow end.

3. The valve prosthesis according to claim 2, characterized in that: The first side includes the first protrusion facing the outflow end, and the second side is arranged parallel to the first side.

4. The valve prosthesis according to claim 1, characterized in that The second fixing member includes a second suture thread, and the second suture thread includes a plurality of loops, and the plurality of loops are wound around the surface of the annular structure.

5. The valve prosthesis according to claim 1, characterized in that At least one side of the annular structure close to the inflow end overlaps with the covering membrane.

6. The valve prosthesis according to claim 2, characterized in that The valve prosthesis also includes a leaflet assembly, and the covering includes an outer covering and an inner covering that are connected to each other. The inner covering is arranged on the inner wall of the stent and is connected to the leaflet assembly, and the outer covering is arranged on the outer wall of the stent. The side of the outer covering close to the outflow end includes a second protrusion facing the outflow end, and the second protrusion is fixed together with the first protrusion by the first fixing member, so that there is no gap between the second protrusion and the filling part in the axial direction.

7. The valve prosthesis according to claim 2, characterized in that The valve prosthesis also includes a leaflet assembly, the stent includes multiple suture rods, the leaflet assembly is arranged in a cavity surrounded by the multiple suture rods and is connected to the multiple suture rods, and the filling part is connected to the suture rods and is located on the outside of the suture rods.

8. The valve prosthesis according to claim 7, characterized in that The coating includes an outer coating and an inner coating, the inner coating is arranged on the inner wall of the stent and connected to the leaflet assembly, the outer coating is arranged on the outer wall of the stent, the inner coating includes an inner coating connection part and an inner coating body, the inner coating connection part protrudes toward the outflow end, the inner coating connection part includes a petal angle connection part and a transition part that are connected to each other, the petal angle connection part is connected to the leaflet assembly and the suture rod, the transition part is used to connect the petal angle connection part and the inner coating body, the suture rod is supported on the surface of the transition part and fixed on the transition part, so that the transition part remains in an expanded state in the axial direction.

9. The valve prosthesis according to claim 8, characterized in that The suture rod is supported on the surface of the transition portion and is fixed to the transition portion by using a third suture line. The third suture line is provided with a plurality of cross suture points along the suture rod.

10. The valve prosthesis according to claim 8, characterized in that The stent includes an inflow end portion close to the inflow end, the inflow end portion includes a free end facing the outflow end, the free end is adjacent to the leaflet assembly, the inner covering film also includes a protective portion, the protective portion is arranged between two adjacent leaflet corner connecting portions, one end of the protective portion is connected to the inner covering film body, and the other end of the protective portion first extends toward the outflow end, then wraps the free end from the inner surface to the outer surface of the stent, and then extends toward the inflow end and is fixed.

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