Valve prosthesis

Abstract

This invention discloses a valve prosthesis, including an inflow end and an outflow end. The valve prosthesis includes a support, a seal, and a cover. The cover at least covers the portion of the support near the inflow end. The seal includes a sealing material, a first fixing member, and a second fixing member. The sealing material includes a first side and a second side disposed opposite to each other. The first side or its vicinity is fixed to the cover with the first fixing member. Then, the second side is rolled or folded to approach the first side, forming an annular structure disposed on the outside of the cover. The second fixing member then fixes the annular structure to the cover. This invention provides a seal that is precisely positioned and shaped on the valve prosthesis support, thereby better adapting to the physiological environment in the body and greatly reducing the occurrence of paravalvular leakage.

Description

Technical Field

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

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

[0003] When the native heart valve narrows, or leaks or regurgitates (e.g., due to leaflet calcification), heart valve replacement surgery can be performed. In one treatment option, the native valve can be removed and replaced with a bioprosthetic or mechanical valve. To prevent paravalvular leakage from the bioprosthetic or mechanical valve, existing technologies use a sealing ring on the outer surface of the bioprosthetic or mechanical valve to seal the gap between the valve and the annulus, preventing blood leakage. However, the sealing ring has a certain thickness, making it difficult to precisely position it at a specific location within the bioprosthetic or mechanical valve. Summary of the Invention

[0004] Therefore, it is necessary to provide a valve prosthesis comprising a stent, a seal, and a cover. The cover at least covers the portion of the stent near the inflow end. The seal comprises a sealing material, a first fixing member, and a second fixing member. The sealing material comprises a first side and a second side disposed opposite to each other. The first side or the area near the first side is fixed to the side of the cover near the outflow end by the first fixing member. Then, the second side is rolled or folded to approach the first side to form an annular structure disposed on the outside of the cover. The annular structure is then fixed to the cover by the second fixing member.

[0005] Compared with existing technologies, the beneficial effects of the above-mentioned valve prostheses are:

[0006] The aforementioned valve prosthesis achieves initial positioning by incorporating a sealing element, including a sealing material, a first fixation element, and a second fixation element. The first fixation element secures the first side or its vicinity to the side of the cover near the outflow end of the valve prosthesis. Then, the second side is rolled or folded to approach the first side, forming an annular structure on the outside of the cover. This process allows for flexible adjustment, enabling precise positioning and shaping of the sealing element on the stent. Finally, the second fixation element secures the annular structure to the cover, achieving final fixation. This results in a sealing element that is precisely positioned and shaped on the valve prosthesis stent, making it more adaptable to the physiological environment and significantly reducing the occurrence of paravalvular leakage. Attached Figure Description

[0007] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

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

[0009] Figure 2 This is a schematic diagram of the structure of the bracket, the unfolded sealing material, and the unfolded covering film in one embodiment of the present invention.

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

[0011] Figure 4 This is a schematic diagram illustrating the interaction between the support, the rolled-up sealing material, and the unfolded covering film in one embodiment of the present invention.

[0012] Figure 5 This is a schematic diagram of the structure of the rolled-up sealing material in one embodiment of the present invention;

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

[0014] Figure 7 This is a schematic diagram of the support structure in one embodiment of the present invention;

[0015] Figure 8 This is a schematic diagram of the membrane structure in one embodiment of the present invention;

[0016] Figure 9 This is a schematic diagram of the unfolded structure of the coating in one embodiment of the present invention;

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

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

[0019] Figure 12 This is a schematic diagram of the suture rod before and after deformation in one embodiment of the present invention;

[0020] Figure 13 This is a schematic diagram of the connection structure between the suture rod and the inflow and outflow ends in one embodiment of the present invention;

[0021] Figure 14 This is a schematic diagram of the structure of a valve prosthesis in one embodiment of the present invention. Detailed Implementation

[0022] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

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

[0024] In the field of interventional medical devices, "distal" is generally defined as the end furthest from the operator during surgery, and "proximal" is defined as the end closest to the operator during surgery. Valve prostheses typically have open and closed states. When the valve prosthesis is open, blood flow can pass through it; when it is closed, blood flow is impeded. When the valve prosthesis is open, refer to... Figure 1 The end where blood flows into the valve prosthesis is defined as the inflow end 242, and the end where blood flows out of the valve prosthesis is defined as the outflow end 241.

[0025] This embodiment provides a valve prosthesis 200 for use as an interventional or surgical valve in locations such as the aortic valve, mitral valve, tricuspid valve, or pulmonary valve, replacing the original valve to achieve heart valve replacement. Figure 1 As shown, the valve prosthesis 200 includes a stent 210, a seal 220, and a liner 260, the liner 260 covering at least the portion of the stent 210 near the inlet end 242.

[0026] See Figures 2 to 6 The sealing element 220 includes a sealing material 2201, a first fixing element 2202, and a second fixing element 2203. The sealing material 2201 includes a first side 2201a and a second side 2201b disposed opposite to each other. The first side 2201a or the area near the first side 2201a is fixed to the film 260 by the first fixing element 2202. Then, the second side 2201b is rolled or folded to approach the first side 2201a to form an annular structure 2201c disposed on the outside of the film 260. The annular structure 2201c is then fixed to the film 260 by the second fixing element 2203.

[0027] In one embodiment, the ring structure 2201c can be understood as a closed-loop structure or an open-loop structure. In another embodiment, the ring structure 2201c can also be a closed-loop structure or an open-loop structure composed of multiple segments.

[0028] The valve prosthesis 200 is initially positioned by setting a sealing element 220, including a sealing material 2201, a first fixing element 2202, and a second fixing element 2203. The first side 2201a or the area near the first side 2201a is fixed to the cover 260 by the first fixing element 2202. Then, the second side 2201b is rolled or folded to approach the first side 2201a, forming an annular structure 2201c on the outside of the cover 260. This process provides a relatively flexible adjustment space, allowing the sealing element 220 to be accurately positioned on the stent 210 and to be accurately shaped. Finally, the second fixing element 2203 is used to fix the annular structure 2201c to the cover 260 to achieve final fixation. This results in a sealing element 220 that is accurately positioned and shaped on the valve prosthesis stent 210, which can better adapt to the physiological environment in the body and greatly reduce the occurrence of paravalvular leakage.

[0029] Understandably, in the actual valve prosthesis fabrication process, after the annular structure 2201c has been fixed to the cover 260 using the second fixation member 2203, forming the valve prosthesis's sealing element 220, it is found that the shape and position of the already formed sealing element 220 still need further adjustment. Generally, the solution is to detach the entire sealing element 220 from the support 210, then adjust the shape of the annular structure 2201c separately, and finally position the annular structure 2201c back onto the support 210. This method is complex, and the positioning and shaping of the sealing element 220 also have significant errors. In this embodiment, the second fixation member 2203 can be removed (e.g., cut off), the second side 2201b can be unfolded and exposed, and the second side 2201b can be rolled or folded to bring it closer to the first side 2201b, forming an annular structure 2201c with a suitable shape and position on the outside of the cover. Then, the second fixation member 2203 is used to fix the annular structure 2201c to the cover 260. Therefore, the shape and position of the seal 220 can be easily adjusted at any time through the seal 220 in this embodiment, and the seal 220 can be accurately positioned and shaped on the valve prosthesis stent 210.

[0030] In one embodiment, when the first side 2201a is fixed to the film 260 by the first fastener 2202, a first protrusion 2201a1 is formed in the direction of the outflow end 241. Along the first protrusion 2201a1, the second side 2201b approaches the first side 2201a by rolling or folding, so that the formed annular structure 2201c has a filling portion 222 that protrudes in the direction of the outflow end 242.

[0031] In the anatomical structure, near the fusion site of the original leaflets, in order to prevent damage to blood vessels, the original leaflets at the fusion site are not completely removed, thus leaving some residual sclerotic tissue. There is a protrusion facing the outflow end between two adjacent fusion sites of the original leaflets. At this protrusion, during the closure of the leaflets, blood flow flows back from the outflow end side of the valve prosthesis to the protrusion, thus causing blood flow to stagnate at the protrusion and form a thrombus.

[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 formed annular structure 2201c has a certain elastic deformation property. After implantation of the valve annulus, the outer wall of the annular structure 2201c fits against the original valve annulus tissue, and the inner wall of the annular structure 2201c fits against the outer wall of the stent 210. The annular structure 2201c is used to seal the gap between the stent 210 and the original valve annulus tissue. The annular structure 2201c also includes a sealing part 221, and a filling part 222 is connected to the sealing part 221. The filling part 222 is located on the side of the sealing part 221 near the outflow end. In this embodiment, the sealing part 221 is generally curved towards the inflow end for better fit against the original valve annulus. Alternatively, see Figure 1 The sealing part 221 can also present a flat shape.

[0033] After the valve prosthesis 200 is implanted at the position corresponding to the original valve annulus, an 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 original valve annulus. The filling part 222 protrudes towards the outflow end, so that after the filling part 222 is implanted, it can extend into the protruding position between the leaflets, thereby squeezing out the blood in the protruding position and preventing blood from stagnating in the protruding position and forming 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 arranged parallel to the first side 2201a. It is understood that when the first side 2201a has the first protrusion 2201a, it is only necessary to connect the first protrusion 2201a to a suitable position on the bracket 210, and then directly wrap the sealing material 2201 around the bracket 210. Furthermore, by arranging the second side 2201b parallel to the first side 2201a, the annular structure 2201c formed after the second side 2201b is rolled or folded to approach the first side 2201a has a uniform diameter, so that the outer edge of the sealing part 221 and the outer edge of the filling part 222 are located on the same circumferential plane, thereby increasing the contact stability between the seal 220 and the original valve ring. In other embodiments, the first protrusion 2201a is not directly provided on the first side 2201a, but is formed by fixing the first side 2201a to the film 260 by the first fastener 2202.

[0035] See again Figure 2 and Figure 6 In this embodiment, the first fixing member 2202 may be a first suture 2202a, which is sutured along one side of the covering 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 fix the annular structure 2201c. In other embodiments, the first fixing member 2202 and the second fixing member 2203 may also be glue or welding materials, etc. At least one side of the annular structure 2201c near the inflow end 242 overlaps with the covering membrane 260, so that the annular structure 2201c and the covering membrane 260 are tightly fitted without gaps, which can better block the leakage of backflowing blood and prevent paravalvular leakage.

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

[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 includes an open state and a closed state. When the leaflet assembly 230 is in the open state, blood flow can pass through the main body 212. When the leaflet assembly 230 is in the closed state, blood flow is obstructed by the leaflet assembly 230 and cannot pass through the main body 212.

[0038] Combination Figure 1 , Figure 8 and Figure 9 The membrane 260 includes an outer membrane 2601 and an inner membrane 2602 connected to each other. The inner membrane 2602 is disposed on the inner wall of the support 210 and connected to the leaflet assembly 230, while the outer membrane 2601 is disposed on the outer wall of the support 260. The outer membrane 2601, near the outlet end 241, includes a second protrusion 2601a facing the outlet end 241. The second protrusion 2601a is correspondingly fixed to the first protrusion 2601a by a first fastener 2202, ensuring that the second protrusion 2601a and the filling portion 222 are axially aligned without any gap. This design increases the length of the outer membrane 2601, improving sealing performance and reducing the possibility of paravalvular leakage. It also ensures that the raised areas between the original leaflet fusion tissues are completely filled by the second raised portion 2601a and the filling portion 222 of the outer membrane 2601, leaving no gaps. This prevents blood from refluxing and accumulating in the raised areas between the original leaflet fusion tissues during the closure of the leaflet assembly 230, thus avoiding thrombus formation.

[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. Multiple suture rods 2121 are spaced apart along the circumferential direction of the stent 210. The leaflet assembly 230 is located inside the stent 210 and connected to the suture rod 2121. The filling part 222 is connected to the suture rod 2121.

[0040] The two ends of the suture rod 2121 are connected to the outflow end 211 and the inflow end 213 of the support 210, respectively. The suture rod 2121 is arranged along the axial direction of the support 210. There are multiple suture rods 2121, which are spaced apart circumferentially along the support 210. The multiple suture rods 2121 together form the main body 212. The leaflet assembly 230 is located inside the main body 212 and is sutured to the side wall of the suture rod 2121.

[0041] like Figure 10 As shown, during the process of switching the leaflet assembly 230 from the closed state to the open state, the leaflet assembly 230 includes multiple leaflets 2301. When the heart is in a contracted state, the free end of the leaflet 2301 is subjected to the pressure of the heart chamber and moves away from the center of the main body 212. The leaflet 2301 pulls the suture rod 2121 away from the center of the stent 210. The suture rod 2121 is pulled away from the center of the stent 210 by the leaflet 2301 to reset. After resetting, the suture rod 2121 is no longer pulled by the leaflet 2301. The filling part 222 is reset with the movement of the suture rod 2121. The angle between the suture rod 2121 and the axis of the stent 210 is a1, and the vertical distance between the filling part 222 and the inflow end of the stent 210 is d1.

[0042] like Figure 11 As shown, during the transition of the leaflet assembly 230 from the open to the closed state, the heart is in diastole. The free end of the leaflet 2301 moves towards the center of the main body 212. The leaflet assembly 230 pulls the suture rod 2121 towards the center of the stent 210. The suture rod 2121 is pulled towards the center of the stent 210 by the leaflet, and the angle between the suture rod 2121 and the axis of the stent 210 is α2. The filling part 222 moves towards the outflow end due to the deformation and pulling effect of the suture rod 2121. The vertical distance between the filling part 222 and the inflow end of the stent 210 is d2. The filling part 222 compresses the protrusion between the original leaflet fusion tissue. The distance d2 is greater than the distance d1. The angle α1 < the angle α2.

[0043] like Figure 12 As shown, Figure 12The diagram shows the suture rod 2121 before and after deformation. The dashed line represents the suture rod 2121 before deformation. The angle between the suture rod 2121 when the leaflet assembly 230 is in the open state and the suture rod 2121 when the leaflet assembly 230 is in the closed state is a3.

[0044] Thus, the stent 210 includes a suture rod 2121, which is arranged along the axial direction of the stent 210. The leaflet assembly 230 is located inside the stent 210 and connected to the suture rod 2121. The opening and closing of the leaflet assembly 230 can pull the suture rod 2121 towards the center of the stent 210 or drive the suture rod 2121 away from the center of the stent 210. The filling part 222 is connected to the suture rod 2121, so that the filling part 222 can move towards the outflow end 241 following the movement of the suture rod 2121. This allows the proximal part of the filling part 222 to compress the protruding position between the original leaflet fusion tissues during the closing of the leaflet assembly 230, thereby facilitating the expulsion of accumulated blood flow in the protruding position between the original leaflet fusion tissues and preventing thrombus formation in this area.

[0045] like Figure 13 As shown, the suture rod 2121 includes a support section 2123, which is located near the outflow end 241 of the support 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 near the inflow end 242.

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

[0047] It should be noted that the support section 2123 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 212 are: 1.5:2:3, the length ratio from the second section 2124 to the midpoint of the support section 2123 is 4, and the length ratio from the first section 2122 to the midpoint of the support section 2123 is 2.5. In this way, the length of the suture rod 2121 from the second section 2124 to the midpoint of the support section 2123 is greater than the length from the first section 2122 to the midpoint of the support section 2123.

[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, with the support section 2123 and the filling part 222 being on both sides of the axial midpoint of the suture rod 2121 respectively, the position of the maximum deformation amount of the suture rod 2121 under the traction of the leaflets is near the inflow end 242 of the suture rod 2121. Thus, it is convenient for 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 bulges 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 section 2123 is located radially outside the outflow end 211 or the inflow end 213. The second section 2124 of the suture rod 2121 is connected to the support section 2123. The second section 2124 is inclined relative to the axis of the stent 210. The end of the second section 2124 close to the support section 2123 is located radially outside the outflow end 211 or the inflow end 213. The included angle between the second section 2124 and the axis of the stent 210 is between 10° and 45°. Specifically, the included angle between the second section 2124 and the axis of the stent 210 is 10°, 15°, 25°, 30° or 45°. The filling part 222 is connected to the second section 2124. The filling part 222 is also inclined relative to the axis of the stent 210. The included angle between the filling part 222 and the axis of the stent 210 is between 10° and 45°. Specifically, the included angle between the filling part 222 and the axis of the stent 210 is 10°, 15°, 25°, 30° or 45°.

[0051] For example, in one embodiment, when the leaflet assembly 230 is in the open state, the suture rod 2121 has been reset, the second section 2124 is in a state 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 section 2124 is inclined relative to the axis of the stent 210, the included angle between the second section 2124 and the axis of the stent 210 is a1, the filling part 222 is inclined relative to the axis of the stent 210, the included angle between the filling part 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 part 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 section 2124 is in a state where it is pulled by the leaflet assembly 230, the force between the suture rod 2121 and the leaflet assembly 230 is large, the included angle between the suture rod 2121 and the axis of the stent 210 is a2, the included angle between the filling part 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 part 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 part 222 is closer to the outflow end 241 of the stent 210.

[0052] Thus, with the support section 2123 at least partially protruding towards the radially outer side of the support 210, and the suture rod 2121 and the corresponding portion of the filling part 222 tilted towards the radially outer side of the support 210, when the suture rod 2121 is not pulled by the leaflet assembly 230, the filling part 222 is tilted relative to the end of the support 210. When the suture rod 2121 is stretched by the leaflet assembly 230, the filling part 222 moves towards the radially inner side of the support 210 along with the suture rod 2121. The distal end of the filling part 222 has a large displacement in the axial direction along the support 210, which facilitates the filling part 222 to compress the sidewall of the original leaflet fusion area.

[0053] See again Figure 9 In one embodiment, the inner membrane 2602 includes an inner membrane connecting portion 2602a and an inner membrane body 2602b. The inner membrane connecting portion 2602a protrudes towards the outflow end and includes a flap corner connecting portion 2602a1 and a transition portion 2602a2 that are connected to each other. Figure 14 The valve angle connection 2602a1 is connected to the leaflet assembly 230 and the suture rod 2121. The transition part 2602a2 is used to connect the valve angle connection 2602a1 and the inner lining 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 is kept in an expanded state in the axial direction to avoid wrinkles, thereby preventing blood from accumulating in the transition part 2602a2 and forming 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 using a third suture 2204, which has a plurality of cross suture points 2204a along the suture rod 2121.

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

[0056] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0057] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A valve prosthesis comprising an inflow end and an outflow end, characterized in that, The valve prosthesis comprises a stent, a sealing member and a covering film, the covering film at least covers a part of the stent near the inflow end, the sealing member comprises a sealing material, a first fixing member and a second fixing member during preparation of the sealing member, the sealing material comprises a first edge and a second edge arranged oppositely, the first edge or a nearby area of the first edge is fixed with the covering film by the first fixing member to form a preliminary positioning, then the second edge is brought close to the first edge by rolling or folding and is adjusted in shape and position to form a rolled or folded annular structure arranged outside the covering film and having a proper shape and position, and the annular structure is fixed with the covering film by the second fixing member.

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

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

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

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

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

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

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

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

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

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