valve prosthesis

Abstract

This invention relates to a valve prosthesis, which includes a support body and an elastic element disposed outside the support body. The support body has a through-hole, and the elastic element is arranged circumferentially around the support body, forming an annular cavity structure with the support body. The through-hole communicates with the annular cavity structure. Thus, by providing a through-hole in the support body, the through-hole communicates with the semi-closed structure, allowing blood flow within the semi-closed structure to flow out through the through-hole, preventing blood from stagnating within the semi-closed structure and forming a thrombus, thus promoting smooth blood flow. Furthermore, blood flow in the opposite direction can flow into the elastic element, where it is buffered, preventing blood from directly overflowing from the sidewall of the stent due to the through-hole in the inner fabric, thus avoiding paravalvular leakage.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a valve prosthesis. Background Technology

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

[0003] Heart valve disease can cause hemodynamic changes, easily leading to lesions in organs such as the heart and blood vessels. Currently, the most effective treatment for valvular disease is to replace the body's own valve with a prosthetic valve. Some valve stents have a perforation to guide blood outflow; however, after blood flows out through this perforation, some blood can easily leak from the side wall of the stent, forming paravalvular leakage. Summary of the Invention

[0004] Therefore, it is necessary to provide a valve prosthesis, including a support body and an elastic member disposed outside the support body. The support body has a through portion, and the elastic member is disposed along the circumference of the support body and surrounds the support body to form an annular cavity structure. The through portion communicates with the annular cavity structure.

[0005] Optionally, the elastic element has an outlet, and the annular cavity structure is connected to the outside through the outlet.

[0006] Optionally, the elastic element includes a connected axial main body and a radial extension, the radial extension extending radially outward along the axial main body, and an outlet is opened on the radial extension.

[0007] Optionally, when the valve prosthesis is in operation, the radial extension is located on the side of the support body closer to the left ventricular outflow tract.

[0008] Optionally, the elastic element includes a support frame, the support frame having greater deformation capacity at the radial extension than at the axial main body.

[0009] Optionally, the support frame includes a first braided wire and a second braided wire. At the radial extension, the first braided wire and the second braided wire intersect and are movably connected. At the axial main body, the first braided wire and the second braided wire intersect and are fixedly connected.

[0010] Optionally, the first and second braided filaments interweave vertically to form a support skeleton, and the number of interweaving points of the first and second braided filaments at the radial extension is less than the number of interweaving points at the longitudinal main body.

[0011] Optionally, in the region where the radial extension is located, the first braided filament crosses at least two intersections with the second braided filament to complete one interlacing.

[0012] Optionally, the elastic element also includes an inner liner and an outer liner, the inner liner being located inside the support frame and the outer liner being located outside the support frame, with an outlet opened on the inner liner and / or the outer liner, and the support frame at the radial extension being movable relative to the inner liner and / or the outer liner.

[0013] Optionally, at the radial extension, the inner and outer cladding films form a suspended section, within which the supporting frame can move.

[0014] Optionally, the inner liner completely covers the inner wall of the support frame, while the outer liner only covers the area of ​​the support frame in the axial main body, and the support frame at the radial extension is exposed on the outside of the inner liner.

[0015] Optionally, the outer membrane completely covers the outer wall of the support frame, the inner membrane only covers the area of ​​the support frame in the axial main body, and the support frame in the radial extension is exposed on the inner side of the outer membrane.

[0016] Optionally, the wire diameter of the supporting skeleton at the radial extension is smaller than the wire diameter at the axial main body.

[0017] Compared with the prior art, the beneficial effects of the valve prosthesis described in this invention are:

[0018] This invention provides a through-hole in the support body, which connects to a semi-closed structure. Blood flow within the semi-closed structure can exit through the through-hole, preventing blood from stagnating and forming thrombi, thus promoting smooth blood flow. Furthermore, the through-hole connects to an elastic element, allowing blood flow in the opposite direction to the blood flow to flow into the elastic element, which buffers the blood flow and prevents blood from overflowing directly from the side wall of the stent due to the through-hole in the inner fabric, thus avoiding paravalvular leakage. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the structure of a valve prosthesis in the prior art;

[0020] Figure 2 This is a schematic diagram of the closed structure formed by the leaflets and the inner fabric in the prior art;

[0021] Figure 3 This is a schematic diagram of the valve prosthesis in Embodiment 1 of the present invention;

[0022] Figure 4 This is a schematic diagram of the axial cross-sectional structure of the valve prosthesis in Embodiment 1 of the present invention;

[0023] Figure 5 This is a schematic diagram of the connection structure between the valve assembly and the inner fabric in Embodiment 1 of the present invention;

[0024] Figure 6This is a schematic diagram of the structure with a through-hole in the inner layer fabric in Embodiment 1 of the present invention;

[0025] Figure 7 This is a schematic diagram of the unfolded structure of the leaflet assembly in Embodiment 1 of the present invention;

[0026] Figure 8 This is a schematic diagram of the structure of the bracket in Embodiment 1 of the present invention;

[0027] Figure 9 This is a schematic diagram of the valve prosthesis in Embodiment 2 of the present invention;

[0028] Figure 10 This is a schematic diagram of the axial cross-sectional structure of the valve prosthesis in Embodiment 2 of the present invention;

[0029] Figure 11 This is a schematic diagram of the elastic element in Embodiment 2 of the present invention;

[0030] Figure 12 For the present invention Figure 11 Enlarged schematic diagram of the structure at point A in the diagram;

[0031] Figure 13 This is a schematic diagram of the valve prosthesis installation structure on the valve annulus in Embodiment 2 of the present invention;

[0032] Figure 14 This is a schematic diagram of the unfolded structure of one embodiment of the support in Embodiment 3 of the present invention;

[0033] Figure 15 This is a schematic diagram of the unfolded structure of another embodiment of the support in Embodiment 3 of the present invention;

[0034] Figure 16 This is a schematic diagram showing the different diameters of the metal rods of the bracket in Embodiment 3 of the present invention;

[0035] Figure 17 For the present invention Figure 16 Enlarged schematic diagram of the structure at point C;

[0036] Figure 18 This is a schematic diagram showing the arrangement of the flow-blocking membrane in the first and second flow sections in Embodiment 3 of the present invention;

[0037] Figure 19 This is a schematic diagram of the elastic element in Embodiment 4 of the present invention;

[0038] Figure 20 This is a top view of the elastic element in Embodiment 4 of the present invention;

[0039] Figure 21 For the present invention Figure 20A schematic diagram of the cross-sectional structure at point AA;

[0040] Figure 22 A schematic diagram of the valve prosthesis in Embodiment 4 of the present invention;

[0041] Figure 23 This is a schematic diagram of the axial cross-sectional structure of the valve prosthesis according to Embodiment 4 of the present invention;

[0042] Figure 24 This is a schematic diagram of the structure of a valve ring in the prior art;

[0043] Figure 25 This is a schematic diagram of the supporting frame structure in Embodiment 4 of the present invention;

[0044] Figure 26 This is a top view of the support frame in Embodiment 4 of the present invention;

[0045] Figure 27 This is a schematic diagram of the unfolded structure of the support frame in Embodiment 4 of the present invention;

[0046] Figure 28 For the present invention Figure 27 A magnified schematic diagram of the structure at point B in the diagram;

[0047] Figure 29 This is a schematic diagram of the connection structure of the film and the supporting skeleton in one embodiment of the present invention (Volume 5).

[0048] Figure 30 This is a schematic diagram of the connection structure between the film and the supporting skeleton in another embodiment of the present invention, as shown in Embodiment 5.

[0049] Figure 31 This is a schematic diagram of the connection structure between the membrane and the supporting skeleton in another embodiment of the invention, as shown in Embodiment 5.

[0050] Figure 32 This is a schematic diagram of the interlacing structure of the braided yarns of the supporting skeleton in Embodiment 5 of the present invention;

[0051] Figure 33 This is a schematic diagram of the valve prosthesis in Embodiment Six of the present invention;

[0052] Figure 34 This is a schematic diagram of the axial cross-sectional structure of the valve prosthesis in Embodiment Six of the present invention;

[0053] Figure 35 This is an isometric view of the elastic element in Embodiment Six of the present invention;

[0054] Figure 36 This is a front view of the elastic element in Embodiment Six of the present invention;

[0055] Figure 37 This is a schematic diagram of another embodiment of the valve prosthesis in Embodiment Six of the present invention;

[0056] Figure 38 A schematic diagram of another embodiment of the elastic element in Embodiment Six of the present invention;

[0057] Figure 39 For the present invention Figure 35 A schematic diagram of the axial cross-sectional structure of the elastic element in the diagram;

[0058] Figure 40 This is a schematic diagram of the axial cross-sectional structure of the elastic element in Embodiment Six of the present invention. Detailed Implementation

[0059] 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.

[0060] 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.

[0061] In the field of interventional medical devices, "distal" is usually defined as the end furthest from the operator during surgery, and "proximal" is defined as the end closest to the operator during surgery. In this invention, however, the end from which blood flows in is defined as the distal end, and the end from which blood flows out is defined as the proximal end.

[0062] Example 1

[0063] This embodiment provides a valve prosthesis that can be used to replace various types of human valves, such as aortic valves, pulmonary valves, tricuspid valves, etc., and is particularly suitable for mitral valves. To facilitate the description of the working principle of the valve prosthesis in this application, this embodiment uses the mitral valve as an example to illustrate the valve prosthesis of this invention.

[0064] like Figures 3 to 5 As shown, the valve prosthesis includes a support body and a leaflet assembly 230. The support body includes a scaffold 210 and an inner fabric 220.

[0065] The stent 210 is used to mount the leaflet assembly 230 and is fixed to the valve annulus after implantation in the human body. In this embodiment, the stent 210 has a certain degree of elasticity, and its diameter is slightly larger than the valve annulus. After the stent 210 is implanted into the valve annulus, it is held in place. For example, when the stent 210 is implanted at the location of the mitral valve, the sidewall of the stent 210 fits against the valve annulus with a certain elastic force, thereby achieving an interference fit between the stent 210 and the valve annulus to limit the valve prosthesis at the valve annulus.

[0066] In this embodiment, as Figure 3 , Figure 4 As shown, the inner fabric 220 is disposed on the side wall of the support 210 to form a support body, and the inner fabric 220 is used to provide a connection position for the leaflet assembly 230. It should be noted that the material of the inner fabric 220 can be any one of PET, PTFE, PU, ​​or PA. The inner fabric 220 can be connected to the support 210 by heat pressing, sewing, or bonding. The inner fabric 220 can be connected to the outer or inner side wall of the support 210.

[0067] Please see Figures 4 to 7 The leaflet assembly 230 is connected to the inner fabric 220 and located inside the support 210. The leaflet assembly 230 includes at least two leaflets, all of which include a suture portion 231 and a movable portion 232. The suture portion 231 of the leaflet is sutured to the inner fabric 220, and the movable portion 232 is a free end that can move away from or towards the inner fabric 220 with the heartbeat.

[0068] The leaflet assembly 230 includes an open state and a closed state. When the leaflet assembly 230 is in the open state, the movable portions 232 of all leaflets are attached to or close to the inner fabric 220, allowing blood to pass through the inside of the stent 210. When the leaflet assembly 230 is in the closed state, the movable portions 232 of all leaflets are away from the inner fabric 220, and the movable portions 232 on two adjacent leaflets at least partially overlap to form a blockage inside the stent 210.

[0069] In one implementation, such as Figure 7As shown, the leaflet assembly 230 includes a first leaflet 233, a second leaflet 234, and a third leaflet 235 equidistantly spaced along the circumference of the inner fabric 220. Each of the three leaflets includes a movable portion 232 and a suture portion 231. The suture portion 231 is arc-shaped and sutured to the inner fabric 220 along its arc-shaped contour. The movable portion 232 is approximately straight. The leaflet assembly 230 is made of biological tissue or synthetic materials. For example, the biological tissue can be any one of bovine pericardium, sheep pericardium, porcine pericardium, or equine pericardium tissue, and the synthetic material can be polyurethane, polytetrafluoroethylene, or silicone polyester. During operation, when the leaflets are open, blood flow can pass through the leaflet assembly 230 into the stent 210; when the leaflets are closed, the leaflet assembly 230 blocks blood flow from passing through it.

[0070] In this embodiment, please refer to Figure 5 , Figure 6 The inner fabric 220 has a through portion 221 facing the radially outer side of the support 210. When the leaflet assembly 230 is in the closed state, the through portion 221 covers at least the area between the proximal and distal ends of the leaflet assembly 230.

[0071] The through-hole 221 is formed on the circumferential sidewall of the inner fabric 220 and faces the radially outward side of the support 210. The position of the through-hole 221 corresponds to the position of the leaflet on the leaflet assembly 230. It can be understood that there can be multiple through-holes 221, and the number of through-holes 221 corresponding to each leaflet can be the same or different. In this embodiment, the number of through-holes 221 is not limited. Specifically, there can be 1, 2, 3 or 6 through-holes 221.

[0072] It should be noted that you should return to [the previous page]. Figure 2 When the leaflet assembly 230 is in the closed state, the radial projection area of ​​the leaflet assembly 230 on the inner fabric 220 refers to the radial projection area S1 of all the leaflets of the closed leaflet assembly 230 on the inner fabric 220. When the through portion 221 is located within the shadow area S1, the through portion 221 can cover the area between the proximal and distal ends of the leaflet assembly 230.

[0073] In the prior art, when the leaflet assembly 230 is in the open state, the movable part 232 of the leaflet is attached to or close to the inner fabric 220; when the leaflet assembly 230 switches from the open state to the closed state, the movable part 232 of the leaflet moves toward the distal end until the edge of the movable part 232 overlaps with the movable part 232 of another adjacent leaflet, thereby closing the leaflet assembly 230. At this time, the leaflet and the shaded area S1 on the inner fabric 220 enclose a semi-closed structure 140 with an opening on one side, and the opening of the semi-closed structure 140 faces the proximal end.

[0074] Thus, when the leaflet assembly 230 is in the closed state, the leaflets and the inner fabric 220 form a semi-closed structure 140. When the leaflet assembly 230 is in the closed state, the heart pushes the blood flow in the direction of blood flow against the flow through the valve. At this time, the blood flow will generate eddies and slow down after entering the semi-closed structure 140, which makes it easy for thrombi to accumulate in the semi-closed structure 140 in this area. By opening a through-hole 221 on the inner fabric 220, the through-hole 221 faces the radial outer side of the stent 210. When the leaflet assembly 230 is in the closed state, the through-hole 221 is at least partially located in the radial projection area of ​​all leaflets on the inner fabric 220 when the leaflet assembly 230 is in the closed state. This allows the through-hole 221 to communicate with the semi-closed structure 140, and the blood flow in the semi-closed structure 140 can flow out through the through-hole 221, avoiding blood flow stagnation in the semi-closed structure 140 and the formation of thrombi, thus promoting the smooth flow of blood.

[0075] In this embodiment, please refer to Figures 5 to 7 The distal end of the through-hole 221 corresponds to the outline of the leaflet assembly 230, and the proximal end of the through-hole 221 is nearly flush with the proximal end of the inner fabric 220. The through-hole 221 extends from the proximal end of the inner fabric 220 to the position where the leaflet and the inner fabric 220 are sewn together. Specifically, the through-hole 221 includes a first edge 2211 and a second edge 2212. The first edge 2211 is nearly flush with the proximal end of the inner fabric 220, and the second edge 2212 coincides with the sewn end of the leaflet, that is, the second edge 2212 is arc-shaped. There are three through-holes 221, and the three through-holes 221 correspond to the first leaflet 233, the second leaflet 234, and the third leaflet 235, respectively.

[0076] Therefore, when the leaflet assembly 230 is in the closed state, the distal end of the through-hole 221 corresponds to the outline of the leaflet assembly 230, and the proximal end of the through-hole 221 is flush with the inner fabric 220, so that the through-hole 221 completely covers the area of ​​the inner fabric 220 covered by the radial projection of the leaflet, thereby eliminating the semi-closed structure 140 formed by the leaflet and the skirt fabric, and avoiding the formation of eddies.

[0077] In this embodiment, please refer to Figure 6 , Figure 7The through portion 221 has a circumferentially continuous structure along the inner layer fabric 220, and the distal edge of the through portion 221 is set along the stitching trajectory of the leaflet assembly 230.

[0078] It should be noted that in this embodiment, the through portion 221 has a circumferentially continuous structure, that is, the distal edge of the through portion 221 is continuous along the edges of the sewn ends of the first leaf 233, the second leaf 234, and the third leaf 235, and the first edge 2211 of the through portion 221 is flush with the proximal end of the inner layer fabric 220. Specifically, the circumferentially adjacent edges of the sewn portions 231 of the first leaf 233 and the second leaf 234 are fitted together, the circumferentially adjacent edges of the sewn portions 231 of the second leaf 234 and the third leaf 235 are fitted together, and the circumferentially adjacent edges of the sewn portions 231 of the third leaf 235 are fitted together. When the distal edge of the through portion 221 is provided along the edges of the sewn portions 231 of the first leaf 233, the second leaf 234, and the third leaf 235, the through portion 221 exhibits a circumferentially continuous structure. Therefore, by making the through portion 221 a circumferentially continuous structure along the inner layer fabric 220, and by setting the distal edge of the through portion 221 along the stitching trajectory of the leaflet assembly 230, the area of ​​the through portion 221 can be maximized, thereby eliminating the semi-closed structure 140 and avoiding the generation of eddies.

[0079] In this embodiment, please refer to Figure 8 The stent 210 includes a support rod assembly 211, a wave structure 212, and a skirt portion 213. The support rod assembly 211 is arranged axially along the stent 210, and there are multiple support rod assemblies 211 distributed circumferentially along the stent 210. The axial ends of the multiple support rod assemblies 211 intersect at the proximal end of the stent 210. The wave structure 212 is connected to the support rod assembly 211 to increase the radial support performance of the stent 210. The skirt portion 213 is connected to the crest of the furthest wave structure 212 or to the furthest end of the support rod assembly 211. The support rod assembly 211 and the wave structure 212 form the main structure. The skirt portion 213 is connected to the furthest end of the main structure and is inclined radially outward from the main structure. The inner fabric 220 is connected to the sidewall of the main structure, and the valve assembly 230 is located inside the main structure.

[0080] In one implementation, please refer to Figure 8The support rod assembly 211 includes a first support rod 2111, a second support rod 2112, and a third support rod 2113. The first axial ends of the first support rod 2111 and the second support rod 2112 extend along the axial direction of the bracket 210. The second axial ends of the first support rod 2111 and the second support rod 2112 are connected and inclined toward the radially inner side of the bracket 210. One end of the third support rod 2113 is connected to the second axial ends of the first support rod 2111 and the second support rod 2112. The other end of the third support rod 2113 is connected to the third support rod 2113 of all other support rod assemblies 211 and converges at the center of the proximal end of the bracket 210.

[0081] The first support rod 2111 and the second support rod 2112 extend axially to form the inflow section 215 and the intermediate section 216 of the bracket 210; the portions of the first support rod 2111 and the second support rod 2112 that are inclined radially inward and the portion of the third support rod 2113 form the outflow section 217; the waveform structure 212 includes a first waveform structure 2121 and a second waveform structure 2122, the first waveform structure 2121 is welded to or integrally connected to the inflow section 215, and the second waveform structure 2122 is welded to or integrally connected to the intermediate section 216. Therefore, by setting the first waveform structure 2121 and the second waveform structure 2122 only in the inflow section 215 and the outflow section 217, the number of support rods on the outflow section 217 of the stent 210 (the waveform structure 212 can also be regarded as a support rod) is less than the number of support rods on the inflow section 215 and the outflow section 217, thereby making the flow area on the outflow section 217 larger than the flow area on the inflow section 215 and the outflow section 217, and increasing the smoothness of blood flow.

[0082] In this embodiment, as Figure 8 As shown, one end of the skirt portion 213 is connected to the crest of the farthest waveform structure 212, and the other end of the skirt portion 213 is inclined towards the radially outer side of the main body of the support 210. The skirt portion 213 includes a plurality of connecting rods 2131 connected end to end. All connecting rods 2131 are inclined towards the radially outer side of the main body of the support 210, and adjacent connecting rods 2131 have a certain included angle. The included angle between adjacent connecting rods 2131 is between 90° and 120°. Specifically, the included angle between adjacent connecting rods 2131 can be 90°, 100°, 110°, or 120°. The connection point between adjacent connecting rods 2131 is an arc-shaped structure 2132 to avoid the connecting edge of the connecting rod 2131 being too sharp and piercing the inner wall of the heart. It is understood that in other embodiments, the skirt portion 213 can also be connected to the distal end of the support rod assembly 211.

[0083] Therefore, when the stent 210 is implanted at the valve annulus, it is connected to the waveform structure 212 or the support rod assembly 211 through the skirt portion 213. The other end of the skirt portion 213 is inclined toward the radial outer side of the stent 210, so that the skirt portion 213 can be locked on the edge of the valve annulus, which increases the anti-displacement performance of the stent 210 and reduces the risk of the stent 210 shifting due to the influence of heart pulsation.

[0084] like Figure 5 As shown, the bracket 210 also includes anchors 214, which are connected to the support rod assembly 211 and inclined towards the radially outer side of the bracket 210. The angle between the anchor 214 and the axial direction of the bracket 210 is between 30° and 60°, specifically, the angle between the anchor 214 and the axial direction of the bracket 210 can be 30°, 40°, 45°, or 60°. In one embodiment, there are multiple anchors 214, all inclined towards the radially outer side of the bracket 210. The anchors 214 include a first anchor 214 and a second anchor 214. The first anchor 214 is connected to the first support rod 2111, and the second anchor 214 is connected to the second support rod 2112. It is understood that in other embodiments, the anchors 214 may also be connected to the wave structure 212 or the third support rod 2113.

[0085] It is understood that the scaffold 210 can be formed by cutting a shape memory alloy, and the sidewalls of the scaffold 210 have a mesh structure. In other embodiments, the scaffold 210 can also be formed by weaving shape memory alloy wires or by electrospinning. The scaffold 210 can be made of biocompatible materials such as nickel-titanium alloy, stainless steel, polyamide, or polylactic acid.

[0086] Please return Figure 3 and Figure 4 The sidewall of the skirt portion 213 is further covered with a flow-blocking membrane 240. The flow-blocking membrane 240 may cover the end face of the skirt portion 213 away from the leaflet assembly 230, or the end face of the skirt portion 213 close to the leaflet assembly 230, or simultaneously cover both the end faces of the skirt portion 213 away from and away from the leaflet assembly 230. The flow-blocking membrane 240 may be at least one of a PET flow-blocking membrane, a PTFE flow-blocking membrane, or a PA flow-blocking membrane. The flow-blocking membrane 240 may be sewn to the skirt portion 213, bonded to the skirt portion 213, or bonded to the skirt portion 213 by heat pressing.

[0087] Therefore, by covering the sidewall of the skirt portion 213 with a flow-blocking membrane 240, the flow-blocking membrane 240 can form a barrier on the skirt portion 213. When blood flows through the through portion 221 and flows toward the distal end, the flow-blocking membrane 240 can block the blood flow, reducing the probability of blood overflowing from the circumferential sidewall of the stent 210 and forming paravalvular leakage.

[0088] Example 2

[0089] The difference between this embodiment and Embodiment 1 is that, as Figure 9 , Figure 10 As shown, the valve prosthesis also includes a circular elastic element 350, which is sleeved on the outer wall of the stent 310. The elastic element 350 and the stent 310 enclose a ring cavity structure, and the through part communicates with the ring cavity structure.

[0090] like Figure 9 As shown, the elastic element 350 is arranged around the circumference of the support 310, forming an elastic buffer zone on the outside of the support 310. After the valve prosthesis is implanted into the human body, the sidewall of the elastic element 350 fits against the human valve annulus and has a certain radial elastic force. Under the radial elastic force, the elastic element 350 is interference-fitted with the human valve annulus to achieve the limiting of the valve prosthesis at the human valve annulus.

[0091] like Figure 10 , Figure 11 As shown, the elastic member 350 is connected to the circumferential sidewall of the support 310 and extends from the inflow section to the outflow section, and the elastic member 350 at least partially covers the area where the through section is located. The radial cross-sectional structure of the sidewall of the elastic element 350 is L-shaped. Specifically, the elastic element 350 includes a circumferential sidewall 352 and a proximal end face 353. The circumferential sidewall 352 is perpendicular to the proximal end face 353. The distal end of the circumferential sidewall 352 is connected to the skirt portion. The flow-blocking membrane 340 on the skirt portion is attached to the distal end of the circumferential sidewall 352 to form the distal end face of the elastic element 350. The proximal end of the circumferential sidewall 352 and the proximal end face 353 are connected. The proximal end face 353 is connected to the sidewall of the stent 310. The space between the distal end face and the proximal end face 353 constitutes a flow port 351. The area covered by the flow port 351 at least partially overlaps with the area covered by the through portion to achieve communication between the flow port 351 and the through portion. Blood flow sequentially passes through the through portion and the flow port 351 into the elastic element 350.

[0092] For example, in one implementation, such as Figure 10 As shown, after the valve prosthesis is implanted in the human body, when the heart compresses the blood flow in the direction against the valve flow (in the direction indicated by arrow f), the valve assembly 330 is in a closed state, and the blood flow flows in the direction against the valve flow. Then, under the obstruction of the valve assembly 330 and the pressure of the heart, the blood flow passes through the through-hole and the flow port 351 and flows into the elastic member 350. When the heart pumps the blood flow in the direction with the valve flow, the valve assembly 330 is in an open state, and the blood in the elastic member 350 flows back into the ventricle under the action of gravity.

[0093] like Figure 11As shown, a central through hole 354 extending through the axial distal end face is provided on the proximal end face 353 of the elastic element 350, and the bracket 310 passes through the central through hole 354. The bracket 310 is connected to the proximal end face 353 of the elastic element 350. Specifically, the bracket 310 can be welded, sewn, or integrally connected to the proximal end face 353 of the elastic element 350.

[0094] The advantage of this design is that by setting the elastic element 350 as a cavity structure, with the annular cavity structure connected to the through-hole, on the one hand, blood flow in the opposite direction of blood flow can flow into the elastic element 350, allowing the blood flow to be buffered within the elastic element 350, preventing blood flow from directly overflowing from the side wall of the stent 310 and forming paravalvular leakage due to the through-hole on the inner layer fabric 320; on the other hand, since the elastic element 350 is sleeved on the stent 310, the elastic element 350 forms a secondary flow obstruction on the outer side wall of the stent 310, preventing blood flow from leaking from the circumferential side wall 352 of the stent 310 due to the through-hole, further reducing the probability of paravalvular leakage.

[0095] In this embodiment, please refer to Figure 11 The elastic element 350 includes a support frame 355 and a sealing membrane 356, with a flow-blocking membrane 340 disposed on the sidewall of the support frame 355. It should be noted that the support frame 355 has a ring-shaped structure and can be formed by weaving or cutting from nickel-titanium alloy. The material of the weaving wire includes nickel-titanium alloy wire or stainless steel wire, and other biocompatible materials with a certain degree of elasticity. The sealing membrane 356 can be a PET film, a PTFE film, or a PU film. When the sealing membrane 356 is a PET film, it is sewn or bonded to the sidewall of the support frame 355; when the sealing membrane 356 is a PTFE film, it is hot-pressed and bonded to both sides of the sidewall of the support frame 355 using a hot-pressing process. Therefore, by including a support frame 355 and a sealing membrane 356 in the elastic element 350, and with the sealing membrane 356 covering the side wall of the support frame 355, the support frame 355 has good elasticity and deformation properties, thus giving the elastic element 350 good elasticity to adapt to the deformation of the heart during contraction and relaxation. By covering the side wall of the support frame 355 with the sealing membrane 356, the support frame 355 is sealed, and the surface of the sealing membrane 356 is relatively smooth, making the flow of blood within the elastic element 350 smoother, thereby reducing the probability of blood stagnation within the elastic element 350 and forming cumulative thrombi.

[0096] Please see Figure 11 , Figure 12Multiple positioning grooves 3531 are formed on the proximal end face 353 of the elastic element 350. The openings of the positioning grooves 3531 are oriented towards the center of the central through hole 354. The multiple positioning grooves 3531 are arranged at equal intervals along the axial direction of the elastic element 350. The positioning grooves 3531 are positioned and engaged with the support rod assembly 311. Specifically, the positioning grooves 3531 include a first positioning groove 3531 and a second positioning groove 3531b. The outline of the first positioning groove 3531a corresponds to the outline of the first support rod 3111, and the outline of the second positioning groove 3531b corresponds to the outline of the second support rod 3112. When the elastic element 350 is sleeved on the main body of the bracket 310, the first support rod 3111 is inserted into the first positioning groove 3531a, and the second support rod 3112 is inserted into the second positioning groove 3531b. Then, the connection between the elastic element 350 and the bracket 310 is achieved by welding the positioning grooves 3531 and the support rod assembly 311. Therefore, by positioning the positioning groove 3531 and the support rod assembly 311, the support rod assembly 311 can limit the axial displacement of the elastic element 350, preventing the elastic element 350 from shifting under the compression of the valve annulus, thereby increasing the structural stability of the valve prosthesis.

[0097] Further, please refer to Figure 11 An outlet 357 is provided on the near end face 353 of the elastic member 350. The outlet 357 is connected to the annular cavity structure inside the elastic member 350. The annular cavity structure is connected to the outside through the outlet 357.

[0098] In this embodiment, the proximal end face 353 of the elastic member 350 is radially parallel to the stent 310, and the opening direction of the outlet 357 is perpendicular to the proximal end face 353 of the elastic member 350, that is, the opening direction of the outlet 357 is oriented towards the proximal end of the stent 310. This embodiment does not limit the shape of the outlet 357; for example, the shape of the outlet 357 can be rectangular, circular, or triangular. The outlet 357 is used to drain blood flowing into the elastic member 350.

[0099] In one embodiment, when the valve assembly 330 is in the closed state and the blood flow is in the reverse direction, the blood flow sequentially passes through the through portion and the flow port 351 into the elastic member 350, and then, under the pressure of the heart, the blood flow can flow out through the outlet 357. The outlet 357 is formed on the sealing membrane 356 on the proximal end face 353.

[0100] Please see Figure 11The outlet 357 has a larger cross-sectional area on the side closer to the stent 310 than on the side farther from the stent 310. The size of the outlet 357 refers to the opening area of ​​the outlet 357 in the circumferential direction of the elastic member 350. Therefore, by setting the outlet 357 to have a larger cross-sectional area on the side closer to the stent 310 and a smaller cross-sectional area on the side farther from the stent 310, on the one hand, the blood flow rate is larger on the side closer to the stent 310, facilitating blood outflow; on the other hand, the blood flow rate is smaller on the side farther from the stent 310, and setting the outlet 357 to have a smaller cross-sectional area on the side farther from the stent 310 effectively reduces the impact of the outlet 357 on the radial support force of the elastic member 350. In other embodiments, the cross-sectional area of ​​the outlet 357 decreases from the side closer to the stent 310 to the side farther from the stent 310.

[0101] It is understood that in other embodiments, the size of the outlet 357 on the side closer to the support 310 is smaller than the size on the side farther from the support 310.

[0102] like Figure 11 , Figure 13 As shown, when the valve prosthesis is in working condition, the outlet 357 is located on the side of the elastic element 350 near the left ventricular outflow tract 150.

[0103] The left ventricular outflow tract 150 is located on one side of the mitral valve annulus. When a mitral valve prosthesis is implanted, the valve assembly 330 is open during diastole, and blood passes through the valve prosthesis into the left ventricle. During systole, the valve assembly 330 is closed, and blood enters the left ventricular outflow tract 150 under the pressure of the heart.

[0104] In this embodiment, there are one or more outlets 357, and all outlets 357 are opened on the side of the proximal end face 353 of the elastic member 350 near the left ventricular outflow tract 150. Thus, the elastic member 350 is deformed under the compression of the heart. The deformed elastic member 350 compresses the blood flow inside the elastic member 350 towards the outlet 357. The blood flows from the outlet 357 towards the left ventricular outflow tract 150, thereby facilitating the outflow of blood from the left ventricular outflow tract 150.

[0105] It is understood that in other embodiments, the elastic element 350 is a ring-shaped cavity structure. Specifically, the elastic element 350 includes an axial proximal end face, an axial distal end face, a circumferential outer wall, and a circumferential inner wall, which together form a cavity structure. The axial proximal end face, axial distal end face, circumferential outer wall, and circumferential inner wall are all made of elastic material. When the circumferential outer wall of the elastic element 350 is compressed, corresponding portions of the circumferential outer wall, axial proximal end face, and axial distal end face of the elastic element 350 can undergo adaptive deformation. Therefore, by setting the axial distal end face of the elastic element 350 as a flow-blocking membrane 340 or by covering the axial distal end with a flow-blocking membrane 340, the flow-blocking membrane 340 can form a flow-blocking layer at the distal end of the elastic element 350, preventing blood leakage at the distal end of the elastic element 350.

[0106] It is understood that in other embodiments, the elastic element 350 can be integrally cut and formed with the bracket 310. For example, in one embodiment, a nickel-titanium alloy tube is provided, and the bracket 310 and the elastic element 350 are simultaneously cut into a predetermined shape by laser cutting, thereby achieving an integral connection between the elastic element 350 and the bracket 310.

[0107] It is understood that in other embodiments, a first connecting hole is provided on the circumferential inner sidewall of the elastic member 350, and the first connecting hole is equidistantly spaced along the circumferential inner sidewall of the elastic member 350; a second connecting hole is provided on the bracket 310, and the position of the second connecting hole corresponds to the position of the first connecting hole. The suture thread passes through the first connecting hole and the second connecting hole to realize the connection between the elastic member 350 and the bracket 310.

[0108] It is understood that in other embodiments, there may be multiple flow ports 351, which are spaced apart circumferentially along the elastic member 350 and correspond to the positions of the through portions. It is also understood that in other embodiments, there may be multiple outlets 357, which are spaced apart circumferentially along the elastic member 350 and correspond one-to-one with the positions of the through portions. The multiple outlets 357 being equally spaced circumferentially along the elastic member 350, and the multiple through portions being equally spaced circumferentially along the main body of the bracket 310, with the outlets 357 corresponding one-to-one with the through portions, means that the outlets 357 are located in the direction indicated by the through portions. When the heart compresses blood flow along the valve, blood flows through the entire valve leaflet assembly. Thus, by having multiple outlets 357 spaced circumferentially along the elastic element 350, with the positions of the outlets 357 corresponding one-to-one with the positions of the through-holes, the circumferential blood flow can flow into the elastic element 350 from the through-holes and then flow out evenly through the outlets 357. This avoids inconsistent blood flow pressure in the circumferential position of the elastic element 350, which could cause deformation of the elastic element 350 and squeeze adjacent human valves, leading to deformation of other human valves and affecting the passage of blood on those valves.

[0109] Example 3

[0110] The difference between this embodiment and Embodiment 2 is that, as Figure 14 As shown, in this embodiment, the support 410 has a mesh structure. The support 410 includes a first flow section 418 near the outlet and a second flow section 419 away from the outlet. The amount of fluid passing through the first flow section 418 is less than the amount of fluid passing through the second flow section 419.

[0111] It should be noted that in this embodiment, after the valve prosthesis is implanted into the human body, the outlet is located near the left ventricular outflow tract. That is, it can be understood that after the valve prosthesis is implanted into the human body, the area of ​​the stent 410 near the left ventricular outflow tract is the first flow section 418, and the area away from the left ventricular outflow tract is the second flow section 419.

[0112] In one embodiment, the total mesh area of ​​the stent 410 on the first flow portion 418 is greater than the total mesh area of ​​the region adjacent to the left ventricular outflow tract. For example, as... Figure 14As shown, the support 410 includes a support rod assembly 411 and a corrugated structure 412. The corrugated structure 412 is connected to the support rod assembly 411 to form a mesh structure. The wave height of the corrugated structure 412 on the first flow portion 418 is less than the wave height of the second flow portion 419, and the wave width of the corrugated structure 412 on the first flow portion 418 is less than the wave width of the second flow portion 419. Here, the wave height refers to the vertical distance h between the wave crest and the wave trough, and the wave width refers to the distance w1 between two adjacent wave crests or the distance w2 between two adjacent wave troughs. Thus, through the setting of the wave height and the wave width, the total mesh area on the second flow portion 419 is greater than the total mesh area on the first flow portion 418.

[0113] It can be understood that in other embodiments, it is also possible to set the wave height of the corrugated structure 412 within the second flow portion 419 to be greater than the wave height within the first flow portion 418, and the wave width of the corrugated structure 412 on the first flow portion 418 to be the same as the wave width on the second flow portion 419. Thus, the mesh area on the second flow portion 419 is greater than the mesh area on the first flow portion 418.

[0114] It can be understood that in other embodiments, it is also possible to set the wave width of the corrugated structure 412 within the second flow portion 419 to be greater than the wave width within the first flow portion 418, and the wave height of the corrugated structure 412 within the second flow portion 419 to be the same as the wave height within the first flow portion 418. Thus, the total mesh area on the second flow portion 419 is greater than the total mesh area on the first flow portion 418.

[0115] It can be understood that in other embodiments, the distance between two axially adjacent corrugated structures 412 at the first flow portion 418 is less than the distance at the second flow portion 419. At the first flow portion 418, the distance between two axially adjacent corrugated structures 412 is defined as x1, and at the second flow portion 419, the distance between two axially adjacent corrugated structures 412 is defined as x2, where x1 < x2; thus, the total mesh area on the second flow portion 419 is greater than the total mesh area on the first flow portion 418.

[0116] In another embodiment, as Figure 14 shown, the maximum mesh area S3 on the first flow portion 418 is less than the minimum mesh area S4 on the second flow portion 419.

[0117] It should be noted that the mesh area of ​​different regions of the stent 410 in this embodiment can be compared under the same mesh density or under different mesh densities, as long as the blood flow rate in the first flow section 418 is greater than the blood flow rate in the second flow section 419 when the blood flows through the sidewall of the stent 410. Mesh density refers to the number of mesh openings per unit area. For example, with the same mesh density, the area of ​​a single mesh opening in the second flow section 419 is greater than the area of ​​a single mesh opening in the first flow section 418; with different mesh densities, the sum of the areas of all mesh openings per unit area in the second flow section 419 is greater than the sum of the areas of all mesh openings per unit area in the first flow section 418.

[0118] Therefore, since the stent 410 includes a first flow section 418 near the outlet and a second flow section 419 away from the outlet, the flow rate of fluid in the first flow section 418 is less than that in the second flow section 419. When the heart contracts and compresses the blood flow towards the valve leaflet assembly, the flow rate of blood passing through the stent 410 is inconsistent on both sides. On the side away from the left ventricular outflow tract 150, the mesh area is large, the blood flow rate is large, the pressure is low, the flow velocity is low, and the blood flow entering the elastic element is large. On the side near the left ventricular outflow tract 150, the blood flow rate is small, the pressure is high, and the blood flow quickly enters the elastic element through the through section and then flows out from the outlet. The blood flow stays in the elastic element for a short time and has little impact on the blood flow on the side away from the left ventricular outflow tract 150. Thus, the blood flow forms a unidirectional flow in the elastic element, which promotes the blood flow towards the side of the left ventricular outflow tract 150, making it easier for the blood to flow out from the left ventricular outflow tract 150 and facilitating blood circulation. On the other hand, since the aortic valve is located on the side of the elastic element closer to the left ventricular outflow tract 150, the blood flow on the side closer to the aortic valve is smaller, which can reduce the probability that the blood flow on the side of the elastic element closer to the aortic valve is too large and will compress the aortic valve.

[0119] Furthermore, such as Figure 15 As shown, in this embodiment, the total area of ​​the mesh on the support 410 decreases from the second flow section 419 toward the first flow section 418.

[0120] In this embodiment, the total area of ​​the mesh on the support 410 exhibits a linear changing trend. For example, in Figure 15 In the schematic diagram of the unfolded plan of the stent 410 shown, with the auxiliary line l1 as the center (after actual implantation, l is located at the position of the stent 410 closest to the left ventricular outflow tract), the total area of ​​the mesh of the stent 410 decreases towards both sides of the auxiliary line l.

[0121] In one embodiment, in the planar unfolded schematic diagram of the stent 410, the first flow section 418 includes a third region 4181 and a fourth region 4182, and the second flow section 419 includes a fifth region 4191, a sixth region 4192, a seventh region 4193 and an eighth region 4194. The third region 4181, the fifth region 4191 and the sixth region 4192 are arranged sequentially along the auxiliary line l in a direction away from the left ventricular outflow tract, and the fourth region 4182, the seventh region 4193 and the eighth region 4194 are arranged sequentially along the auxiliary line l in a direction away from the left ventricular outflow tract. Specifically, the area of ​​a single mesh in the third region 4181 is smaller than that in the fifth region 4191, and the area of ​​a single mesh in the fifth region 4191 is smaller than that in the sixth region 4192; the area of ​​a single mesh in the third region 4181 is the same as that in the fourth region 4182, the area of ​​a single mesh in the fifth region 4191 is the same as that in the seventh region 4193, and the area of ​​a single mesh in the sixth region 4192 is the same as that in the eighth region 4194. When blood flows through the sidewall of the stent 410, the flow rate in the third region 4181 is less than that in the fifth region 4191, the flow rate in the fifth region 4191 is less than that in the sixth region 4192; the flow rate in the fourth region 4182 is less than that in the seventh region 4193, and the flow rate in the seventh region 4193 is less than that in the eighth region 4194.

[0122] Therefore, as the total area of ​​the mesh on the stent 410 decreases from the second flow section 419 to the side closer to the first flow section 418, the mesh area on the stent 410 exhibits a linear change. Consequently, the blood flow through the sidewall of the stent 410 decreases from the side away from the left ventricular outflow tract to the side closer to the left ventricular outflow tract. Consequently, the blood flow in the elastic element decreases as it approaches the left ventricular outflow tract, achieving a smooth transition of blood flow from a high-flow area to a low-flow area. This makes the flow within the elastic element more uniform and prevents a sudden increase in flow when the high-flow blood flow away from the left ventricle converges with the blood flow near the left ventricular outflow tract, which could cause the elastic element to expand and compress the left ventricular outflow tract.

[0123] It is understood that in other embodiments, the mesh density on the first flow portion 418 of the support 410 is greater than the mesh density near the second flow portion 419.

[0124] Mesh density refers to the number of mesh openings per unit area. Different mesh densities refer to a comparison when all individual mesh openings have the same area. For the same mesh opening area, a higher mesh density means a greater number of mesh openings per unit area. For example, if all individual mesh openings in the first flow section 418 and the second flow section 419 have the same area, the number of mesh openings per unit area in the first flow section 418 is greater than the number of mesh openings per unit area in the second flow section 419.

[0125] Thus, the greater the mesh density, the greater the blood flow allowed through the area, resulting in a larger flow rate in the second flow section 419 and a smaller flow rate in the first flow section 418. Consequently, the flow rate of the elastic element is smaller on the side closer to the left ventricular outflow tract and smaller on the side farther from the left ventricular outflow tract. On the one hand, this reduces the pressure on the left ventricular outflow tract. On the other hand, the pressure on the side of the elastic element farther from the left ventricular outflow tract is greater than the pressure on the side closer to the left ventricular outflow tract, thereby forming a unidirectional blood flow toward the left ventricular outflow tract, which is more conducive to blood flowing out of the left ventricular outflow tract and promotes blood circulation.

[0126] Furthermore, the mesh density on the main body of the support 410 decreases from the second flow section 419 towards the side closer to the first flow section 418. It should be noted that mesh density refers to the number of mesh openings per unit area. Different mesh densities refer to a comparison when all individual mesh openings have the same area.

[0127] In some embodiments, the number of regions divided by the support 410 can be greater than six or less than six. The more regions divided, the more obvious the linear change in mesh density on the support 410 becomes. In this embodiment, the number of regions divided by the main body of the support 410 is not limited; specifically, it can be 2, 3, 4, 5, or 6.

[0128] In this way, the mesh density on the stent 410 decreases from the second flow section 419 to the first flow section 418, causing the mesh area on the stent 410 to change linearly. This results in the blood flow rate through the sidewall of the stent 410 decreasing from the first flow section 418 to the side closer to the second flow section 419. This makes the blood flow on the elastic element show a pattern where the blood flow rate decreases as it gets closer to the left ventricular outflow tract, achieving a smooth transition of blood flow from a high-flow area to a low-flow area. The flow rate within the elastic element is more uniform, avoiding the situation where a sudden increase in flow rate causes the elastic element to expand and compress the left ventricular outflow tract side when the high-flow blood flow on the side far from the left ventricle converges with the blood flow on the side close to the left ventricular outflow tract.

[0129] It is understood that in other embodiments, the metal coverage on the first flow section 418 is greater than the metal coverage on the second flow section 419.

[0130] It should be noted that the metal coverage rate refers to the ratio of the area of ​​the metal portion to the total planar area of ​​the support after the support 410 is unfolded. A higher metal coverage rate means a larger total area of ​​the support 410 occupied by metal, implying a smaller open area and thus a lower fluid throughput. For example, in one embodiment, such as... Figure 16 , Figure 17 As shown, the diameter of the metal rod d1 on the first flow section 418 is larger than the diameter of the metal rod d2 on the second flow section 419, resulting in a relatively large metal coverage on the first flow section 418 and a relatively small metal coverage on the second flow section 419.

[0131] In this way, by setting the metal coverage rate on the first flow section 418 to be greater than the metal coverage rate on the second flow section 419, the hollow area on the first flow section 418 is smaller than the hollow area on the second flow section 419, thereby making the fluid flow rate on the first flow section 418 less than the fluid flow rate on the second flow section 419.

[0132] Furthermore, the metal coverage rate on the first distribution section 418 is 8%-16%, specifically, the metal coverage rate of the first distribution section 418 can be 8%, 10%, 12%, 14%, or 16%. The metal coverage rate on the second distribution section 419 is 20%-30%, specifically, the metal coverage rate of the second distribution section can be 20%, 22%, 24%, 25%, 26.5%, or 30%.

[0133] It is understood that in other embodiments, the support also includes a flow-blocking membrane, which is disposed on the side wall of the support 410 and at least covers a portion of the mesh on the support 410, and the mesh on the support 410 is at least partially connected to the through portion. The total area of ​​the mesh on the first flow portion 418 covered by the flow-blocking membrane is greater than the total area of ​​the mesh on the second flow portion 419.

[0134] It should be noted that the flow-blocking membrane is located inside the through-hole. After the support is deployed, there is a gap between the edge of the flow-blocking membrane and the edge of the through-hole. This allows blood flow to pass through the through-hole from the edge of the flow-blocking membrane and connect with the annular cavity structure inside the elastic element. For example, as... Figure 18As shown, in one embodiment, the flow-blocking membrane includes a first flow-blocking membrane 421 and a second flow-blocking membrane 422. The first flow-blocking membrane 421 is located in the first flow-through portion 418, and the second flow-blocking membrane 422 is located in the second flow-through portion 419. The area of ​​the first flow-blocking membrane 421 is larger than the area of ​​the second flow-blocking membrane 422. Thus, the total area of ​​the mesh openings on the first flow-through portion 418 covered by the first flow-blocking membrane 421 is greater than the total area of ​​the mesh openings on the second flow-through portion 419 covered by the second flow-blocking membrane 422. Consequently, the flow rate of fluid passing through the first flow-through portion 418 is smaller, and the flow rate passing through the second flow-through portion 419 is larger. It is understood that in other embodiments, a flow-blocking membrane can be provided at the first flow-through portion 418, but not at the second flow-through portion, so that the flow rates of fluid in the first flow-through portion 418 and the second flow-through portion 419 are different.

[0135] It is understood that the stent in this embodiment can be combined with the elastic element in Embodiments 2, 4, 5 and 6 to promote the effect of blood flow forming a unilateral blood flow towards the outlet within the elastic element, which will not be elaborated here.

[0136] Example 4

[0137] The difference between this embodiment and embodiments two and three is that, as Figure 19 , Figure 20 As shown, the elastic member 550 includes a connected axial main body portion 552 and a radial extension portion 553. The radial extension portion 553 extends radially along the axial main body portion 552, and an outlet is provided on the radial extension portion 553.

[0138] In this embodiment, the elastic element 550 can be formed by weaving or cutting a shape memory alloy material. For example, the shape memory alloy material can be a nickel-titanium-based shape memory alloy or an iron-based shape memory alloy. The elastic element 550 has good compliance to adapt to the initial shape of the valve annulus, and the elastic element 550 also has good elasticity to adapt to the shape changes of the valve annulus caused by the heart's beating.

[0139] The elastic element 550 has a ring-shaped closed cavity structure. A flow channel is formed on the inner side of the elastic element 550 for blood flow. The elastic element 550 is attached to the side wall of the stent and has a flow port 551. The elastic element 550 has an outlet 557 on the end face of the valve prosthesis in the distal direction. After the valve prosthesis is implanted into the human body, the blood flows through the through-part and the flow port 551 into the flow channel, and then flows out from the outlet 557 through the flow channel.

[0140] It is understood that, in one embodiment, the elastic element 550 includes a support frame 555 and a sealing membrane 556. The support frame 555 has a ring structure and can be woven or cut from a shape memory alloy material. The shape memory alloy material can be a nickel-titanium-based shape memory alloy or an iron-based shape memory alloy.

[0141] The sealing membrane 556 covers the inner or outer sidewall of the support frame 555, or both. After the sealing membrane 556 covers the sidewall of the support frame 555, the support frame 555 and the sealing membrane 556 form a flow channel, within which blood can flow. The sealing membrane 556 has a flow port 551 on its sidewall that adheres to the stent, and an outlet 557 in the direction indicated by the distal end of the valve prosthesis. After the valve prosthesis is implanted into the human body, blood flows through the perforation and the flow port 551 into the flow channel, and then flows out through the outlet 557.

[0142] like Figure 19 , Figure 20 and Figure 21 As shown, the axial main body 552 is approximately circular (fitting) Figure 16 Middle auxiliary line l2, Figure 18 (As can be clearly shown by auxiliary line l3), the radial extension 553 extends radially along the axial main body 552. The distance d1 of the radial extension 553 from the axis of the central through hole 554 is greater than the distance d2 of the edge of the axial main body 552 from the central through hole 554. The distance d3 of the radial extension 553 extending radially along the axial main body 552 is the distance d1 of the radial extension 553 from the axis of the central through hole 554 minus the distance d2 of the edge of the axial main body 552 from the central through hole 554, i.e., d3 = d2 - d1. The length of d3 is between 3 mm and 7 mm. Specifically, the radial extension length of the extension section can be 3 mm, 4 mm, 5 mm, or 7 mm. In this way, the elastic member 550 has a larger cross-sectional area at the axial main body 552, so that the flow channel size on the side closer to the outlet is larger than the flow channel size on the side farther from the outlet. It is understood that in other embodiments, an axial extension portion may be provided on the side of the elastic member 550 near the outflow channel so that the flow channel volume on the side near the outflow outlet is greater than the flow channel volume on the side away from the outflow outlet. The specific implementation method has been described in Embodiment Six and will not be repeated here.

[0143] like Figures 20 to 23As shown, the axial main body 552 is arranged circumferentially along the bracket 510, the central through hole 554 is opened at the center of the axial main body 552, the bracket 510 is inserted into the central through hole 554, the flow port 551 is opened on the side wall of the axial main body 552 that fits against the bracket 510, the radial extension 553 extends radially along the axial main body 552 and communicates with the axial main body 552, and the outlet 557 is opened on the end face of the radial extension 553 at the distal end of the valve prosthesis.

[0144] After the valve prosthesis is implanted in the human body, the axial main body portion 552 is located on the side of the valve annulus away from the left ventricular outflow tract, and the radial extension portion 553 is located on the side of the valve annulus closer to the left ventricular outflow tract. Blood flows through the through portion and the flow port 551 into the flow channel, then along the flow channel in the axial main body portion 552 into the radial extension portion 553, and finally flows out from the outflow port 557. For example, in one embodiment, such as Figure 23 As shown, when the heart is pumping blood and the valve leaflets are closed, on the side away from the left ventricular outflow tract, blood flows in the direction of f1 through the through-hole and flow port 551 into the elastic element 550. Then, within the elastic element 550, the blood flows towards the side closer to the left ventricular outflow tract (i.e., arrow f2), and then flows out through the outflow port 557 in the direction of f3, exiting the outflow tract. On the side closer to the left ventricular outflow tract, blood flows in the direction of f4 into the elastic element 550, then merges with the blood flow flowing from the side away from the left ventricular outflow tract towards the side closer to the left ventricular outflow tract, and then flows out through the outflow port 557 in the direction of f3. This effectively guides the blood flow to the outflow tract side, preventing blood flow from the side away from the outflow tract from repeatedly returning to the ventricle and failing to reach the outflow tract side, thereby promoting blood circulation.

[0145] It is worth noting that the mitral valve annulus has a saddle-shaped structure (the two sides of the arc are asymmetrical), such as... Figure 24 As shown, the mitral valve annulus 160 has a first wall 161 and a second wall 162. The first wall 161 is the side wall of the mitral valve annulus 160 near the left ventricular outflow tract 150, with a smaller curvature and relatively straight. The second wall 162 is the side wall of the mitral valve annulus away from the left ventricular outflow tract 150, with a larger curvature and relatively curved. When the valve prosthesis is implanted in the position of the valve annulus 160, the circumferential sidewall of the elastic element 550 fits against the valve annulus 160. Since the first wall 161 is relatively straight, the side of the elastic element 550 near the first wall will experience greater compressive force, resulting in greater deformation of the elastic element 550 after compression. This compresses the flow channel of the elastic element 550 near the first wall 161, reduces the cross-sectional area of ​​the flow channel, and obstructs blood flow.

[0146] Thus, by including the interconnected axial main body portion 552 and radial extension portion 553 in the elastic member 550, after the valve prosthesis is implanted into the human body, the radial extension portion 553 can be located on the side closer to the left ventricular outflow tract 150. By extending radially along the axial main body portion 552, the radial extension portion 553 has a greater distance from the center of the stent, thereby increasing the cross-sectional area of ​​the flow channel of the elastic member 550 on the side closer to the left ventricular outflow tract 150. When the elastic member 550 is compressed by the first wall 161, due to the radial extension portion 553… The cross-sectional area of ​​the flow channel at position 3 is relatively large, so that even when the elastic element 550 is compressed by the first wall 161, the flow channel of the elastic element 550 near the first wall 161 still has a certain cross-sectional area, thus ensuring the passage of blood flow in the flow channel. The outlet is opened on the radial extension 553, which is located on the side of the stent near the left ventricular outflow tract 150. This allows the blood flow to flow directly to the outflow tract after passing through the outlet, preventing the blood flow from flowing back into the left ventricle from the side away from the outflow tract, thus facilitating blood circulation.

[0147] Please return to Figure 19 and Figure 24 The support frame 555 is a mesh structure woven from braided yarns. The support frame 555 includes a first sidewall 5551 and a second sidewall 5552. The first sidewall 5551 is arranged circumferentially along the elastic element 550 to form the circumferential sidewall of the elastic element 550. The second sidewall 5552 is connected to the proximal end of the first sidewall 5551 to form the proximal end face of the elastic element 550. The second sidewall 5552 is connected to the stent 510. After the valve prosthesis is implanted into the human body, the first sidewall 5551 fits against the valve annulus, and the second sidewall 5552 is located below the valve annulus or flush with the lower end face of the valve annulus.

[0148] like Figure 19 , Figure 24 As shown, at the radial extension 553, the first sidewall 5551 is radially inclined relative to the elastic member 550, that is, the first sidewall 5551 and the elastic member 550 have a certain radial angle a1. The radial angle a1 between the first sidewall 5551 and the elastic member 550 is between 20° and 80°. Specifically, the radial angle a1 between the first sidewall 5551 and the elastic member 550 can be 20°, 30°, 45°, 60° or 80°.

[0149] When the valve prosthesis is implanted into the valve annulus, the first sidewall 5551 of the radial extension 553 fits against the first wall 161 of the valve annulus 160. By setting the first sidewall 5551 of the radial extension 553 at a certain angle to the radial direction of the elastic member 550, the first sidewall 5551 of the radial extension 553 can tilt towards the side closer to the main support 510, reducing the pressure area of ​​the radial extension 553 on the first wall 161, thereby avoiding excessive pressure from the radial extension 553 on the first wall 161 and squeezing the aortic valve.

[0150] Please return to Figure 19 At the radial extension 553, the outlet 557 is formed on the sealing film 556 covering the second sidewall 5552, the second sidewall 5552 being inclined toward the side closer to the main support 510, i.e., as shown in the figure. Figure 25 As shown, the radial angle a2 between the second sidewall 5552 and the elastic member 550 is a preset angle, which is between 20° and 80°. Specifically, the radial angle between the first sidewall 5551 and the elastic member 550 can be 20°, 30°, 45°, 60° or 80°.

[0151] Thus, at the radial extension 553, an outlet 557 is opened on the second sidewall 5552 at an angle toward the side near the support 510, so that the outlet 557 also tilts toward the side of the left ventricular outflow tract along with the second sidewall 5552, thereby allowing the blood in the flow tract to flow toward the left ventricular outflow tract 150, facilitating the flow of blood into the left ventricular outflow tract 150.

[0152] The first sidewall 5551 at the radial extension 553 includes an arcuate surface structure, wherein the concave surface of the arcuate surface structure is disposed proximally. The arcuate surface structure can be formed by heat setting of a mesh braided structure. It is understood that in other embodiments, the arcuate surface structure can also be formed by cutting shape memory metal. Thus, by including an arcuate surface structure at the first sidewall 5551 at the radial extension 553, with the concave surface of the arcuate surface structure disposed proximally, the side of the arcuate structure near the proximal end has a larger flow channel cross-sectional area, while the side of the arcuate surface structure near the distal end remains inclined to avoid the first wall 161, reducing the pressure of the extension section on the aortic valve. It is understood that in other embodiments, the concave surface of the arcuate surface structure can also be disposed distally.

[0153] like Figure 26 As shown, the support frame 555 includes a first region 5553 located in the radial extension 553 and a second region 5554 located in the axial main body 552. The deformation performance of the first region 5553 is greater than that of the second region 5554.

[0154] It should be noted that deformation performance refers to the amount of deformation of the support frame 555 under pressure. The stronger the deformation performance, the greater the deformation of the support frame 555 under the same pressure; conversely, the weaker the deformation performance, the smaller the deformation of the support frame 555 under the same pressure. Specifically, deformation performance can be tested through in vitro simulation testing using the compression grip method.

[0155] In this embodiment, as Figure 27 , Figure 28 As shown, the support frame 555 is woven from braided wires to form a mesh structure. The braided wires include a first braided wire 5555 and a second braided wire 5556. In the first region 5553, the first braided wire 5555 and the second braided wire intersect and are movably connected. That is, in the first region 5553, the first braided wire 5555 and the second braided wire 5556 only overlap each other. When the first braided wire 5555 and the second braided wire 5556 are subjected to force, the first braided wire 5555 and the second braided wire 5556 can generate relative displacement. For example, in one embodiment, the first region 5553 includes a first intersection point c1 and a second intersection point c2 formed by the intersection of a first braided wire 5555 and a second braided wire 5556, and a third intersection point c3 and a fourth intersection point c4 formed by the intersection of a third braided wire 5557 and a fourth braided wire 5558. When this region is under stress, the first braided wire 5555 and the second braided wire 5556 move in opposite directions, causing the first intersection point c1 and the second intersection point c2 to move towards the side away from the center of the grid, and the third braided wire 5557 and the fourth braided wire 5558 move in opposite directions, causing the third intersection point c3 and the fourth intersection point c4 to move towards the side away from the center of the grid. Thus, when the first region 5553 is under stress, through the intersection and movable connection of the first braided wire 5555 and the second braided wire 5556, the relative movement of the first braided wire 5555 and the second braided wire 5556 causes corresponding deformation of the support frame 555, thereby giving the first region 5553 and the second region 5554 good deformation adaptability.

[0156] Please return Figure 27In the second region 5554, the first braided wire 5555 and the second braided wire 5556 intersect and are fixedly connected. Specifically, in the second region 5554, the first braided wire 5555 and the second braided wire 5556 intersect, and at the intersection point, the first braided wire 5555 and the second braided wire 5556 are fixedly connected. In one embodiment, at the intersection point, the first braided wire 5555 and the second braided wire 5556 can be welded to achieve a fixed connection. In other embodiments, at the intersection point, the first braided wire 5555 and the second braided wire 5556 can also be intertwined or knotted to achieve a fixed connection. Therefore, when the second region 5554 is subjected to force, the intersecting and fixed connection of the first braided wire 5555 and the second braided wire 5556 makes it difficult for them to undergo relative displacement, thus exhibiting strong resistance to deformation.

[0157] It is understood that in other implementations, the first braided filament 5555 and the second braided filament 5556 on the first region 5553 are movably connected at some intersection points, and the first braided filament 5555 and the second braided filament 5556 are fixedly connected at the remaining intersection points (i.e., non-movably connected intersection points). Similarly, on the second region 5554, the first braided filament 5555 and the second braided filament 5556 are movably connected at some intersection points, and the first braided filament 5555 and the second braided filament 5556 are fixedly connected at the remaining intersection points (i.e., non-movably connected intersection points). The number of intersections where the first braided wire 5555 and the second braided wire 5556 are movably connected at the first region 5553 is greater than the number of intersections where the second braided wire 5556 is movably connected. The more intersections where movably connected, the better the deformation performance of the support frame 555. Thus, by having the first braided wire 5555 and the second braided wire 5556 movably connected at the first region 5553 have a greater number of intersections where the second braided wire 5556 is movably connected, the first region 5553 has better deformation performance than the second region 5554.

[0158] It is understood that in other embodiments, the diameter of the braided filament in the first region 5553 is larger than the diameter of the braided filament in the second region 5554. The diameter of the braided filament has a significant impact on its elastic deformation properties. Generally speaking, the larger the diameter of the braided filament, the worse its elastic deformation properties; conversely, the smaller the diameter, the better its elastic deformation properties. In this embodiment, the diameter of the braided filament in the first region 5553 is between 0.15 and 0.2 mm. For example, the diameter of the braided filament in the first region 5553 can be 0.15, 0.16, 0.18, or 0.2 mm. The diameter of the braided filament in the second region 5554 is between 0.2 and 0.25 mm. Specifically, the diameter of the braided filament in the second region 5554 is 0.2, 0.21, 0.22, 0.23, or 0.25 mm. Therefore, by setting different diameters of the braided wires in the first region 5553, the deformation performance of the support frame 555 in the first region 5553 is greater than that of the support frame 555 in the second region 5554. It can be understood that the braided wires can also be mesh wires.

[0159] It is understood that in other embodiments, the support frame 555 is formed by cutting a shape memory alloy, and the metal coverage of the first region 5553 is less than that of the second region 5554. It should be noted that the metal coverage refers to the ratio of the square meter area of ​​the metal portion to the overall planar area of ​​the support frame 555 after it is unfolded. In one embodiment, the metal coverage of the support frame 555 in the first region 5553 is between 5% and 15%, and the metal coverage of the second region 5554 is between 15% and 25%. Specifically, the metal coverage of the support frame 555 in the first region 5553 is 5%, 8%, 10%, or 15%; and the metal coverage of the second region 5554 is 15%, 18%, 20%, or 25%. The fact that the metal coverage rate in the first region 5553 is less than that in the second region 5554 means that the proportion of metal objects in the first region 5553 is greater than that in the second region 5554. The greater the proportion of metal objects, the stronger the resistance to deformation, thus making the deformation performance of the first region 5553 greater than that of the second region 5554.

[0160] The advantage of this arrangement is that the deformation performance at the first region 5553 is greater than that at the second region 5554, making the radial extension 553 easier to deform and thus reducing the pressure of the radial extension 553 on the first wall 161. This reduces the pressure of the radial extension 553 on the aortic valve. In this way, the radial extension 553 can have better deformation performance while ensuring the passability of the flow channel cross-sectional area, so that the elastic member 550 can have better adaptability.

[0161] Example 5

[0162] The difference between this embodiment and embodiments two and four is that, as Figures 29 to 31 As shown, the sealing membrane 656 includes an inner membrane 6561 and an outer membrane 6562. The inner membrane 6561 is located inside the support frame 655, and the outer membrane 6562 is located outside the support frame 655.

[0163] It is understood that the outer membrane 6562 and the inner membrane 6561 may be connected at the edges to cover the support frame 655, or the outer membrane 6562 may be connected to a portion of the outer wall of the support frame 655 and the inner membrane 6561 may be connected to a portion of the inner wall of the support frame 655, or the inner membrane 6561 and the outer membrane 6562 may be connected only at the second region 6554.

[0164] For example, in one implementation, such as Figure 29 As shown, the inner cladding 6561 completely covers the inner wall of the support frame 655, and the outer cladding 6562 completely covers the outer wall of the support frame 655. In the second region 6554, the inner cladding 6561 and the outer cladding 6562 are heat-pressed together. In the first region 6553, the inner cladding 6561 and the outer cladding 6562 are not connected or are only connected at the edges, so that a suspended section is formed between the inner cladding 6561 and the outer cladding 6562. Thus, the inner cladding 6561 and the outer cladding 6562 constrain the braided filaments in the first region 6553, allowing the braided filaments in the support frame 655 to move within the space between the inner cladding 6561 and the outer cladding 6562.

[0165] In another implementation, such as Figure 30 As shown, the inner film 6561 only covers the second region 6554 of the inner sidewall of the elastic member 650, while the outer film 6562 completely covers the outer sidewall of the elastic member 650. The inner film 6561 and the outer film 6562 are heat-pressed together at the second region 6554. Thus, at the first region 6553, only the outer film 6562 covers the braided fibers of the support frame 655. During the heat pressing process, since there is no inner film 6561 at the first region 6553, the outer films 6562 at the first region 6553 do not have opposing sides that are adhered to each other. This causes the outer film 6562 to be suspended outside the support frame 655 after heat pressing, while the support frame 655 is exposed inside the outer film 6562. In this way, the braided fibers at the first region 6553 can move inside the outer film 6562.

[0166] In another implementation, such as Figure 31As shown, the outer film 6562 only covers the second region 6554 of the outer wall of the elastic member 650, while the inner film 6561 completely covers the outer wall of the elastic member 650. The inner film 6561 and the outer film 6562 are heat-pressed together at the second region 6554. Thus, at the first region 6553, only the inner film 6561 covers the braided fibers of the support frame 655. During the heat pressing process, since there is no outer film 6562 at the first region 6553, the inner films 6561 at the first region 6553 do not have opposing sides that are adhered to each other. This causes the inner film 6561 to be suspended inside the support frame 655 after heat pressing, while the support frame 655 is exposed outside the inner film 6561. In this way, the braided fibers at the first region 6553 can move outside the inner film 6561.

[0167] Therefore, by connecting the inner membrane 6561 and the outer membrane 6562 only at the second region 6554, and not connecting the outer membrane 6562 and the inner membrane 6561 at the first region 6553, the inner membrane 6561 and the outer membrane 6562 at the first region 6553 do not restrict the movement of the braided filaments within the first region 6553. This allows the braided filaments of the supporting skeleton 655 to move between the inner membrane 6561 and the outer membrane 6562, thereby reducing the influence of the sealing membrane 656 on the deformation performance of the first region 6553, and further reducing the probability of excessive pressure on the first wall by the extension section.

[0168] It is understood that in other implementations, the sealing film 656 is connected only to the first braided filament 6555 or only to the second braided filament 6556. Specifically, the connection method between the sealing film 656 and the first braided filament 6555 or the second braided filament 6556 can be sewing, heat pressing, or bonding. When the sealing film 656 is connected only to the first braided filament 6555, the sealing film 656 and the first braided filament 6555 have multiple connection points, and the sealing film 656 has a certain deformation allowance between two adjacent connection points. When the sealing film 656 is connected only to the second braided filament 6556, the sealing film 656 and the second braided filament 6556 have multiple connection points, and the sealing film 656 has a certain deformation allowance between two adjacent connection points.

[0169] In one embodiment, when the sealing film 656 is only connected to the first braided filament 6555, and the first braided filament 6555 and the second braided filament 6556 at the first region 6553 are deformed by force and produce relative movement, since the sealing film 656 is not connected to the second braided filament 6556, the second braided filament 6556 will not interfere with the movement of the sealing film 656 following the first braided filament 6555, thereby allowing the sealing film 656 to follow the movement of the first braided filament 6555.

[0170] In one embodiment, when the sealing film 656 is only connected to the second braid 6556, and the first braid 6555 and the second braid 6556 at the first region 6553 are deformed by force and produce relative movement, since the sealing film 656 is not connected to the first braid 6555, the first braid 6555 will not interfere with the movement of the sealing film 656 following the second braid 6556, thereby allowing the sealing film 656 to follow the movement of the second braid 6556.

[0171] Therefore, by connecting the sealing membrane 656 in the first region 6553 only to the first braided filament 6555 or only to the second braided filament 6556, and by providing a certain deformation allowance between adjacent connection points, the sealing membrane 656 can move with either the first or second braided filament 6555. This reduces the constraint of the sealing membrane 656 on the relative movement of the first or second braided filament 6555 or 6556 during deformation, thereby reducing the influence of the sealing membrane 656 on the deformation performance of the first region 6553, and further reducing the probability of excessive pressure on the first wall by the extended section.

[0172] It is understood that this embodiment does not limit the connection method between the sealing film 656 and the first braided filament 6555 and the second braided filament 6556 on the second region 6554. For example, the sealing film 656 can be connected to the first braided filament 6555 and the second braided filament 6556 on the second region 6554 at the same time, or it can be connected only to the first braided filament 6555 or only to the second braided filament 6556.

[0173] It is understood that in other embodiments, such as Figure 32 As shown, the first braided filament 6555 and the second braided filament 6556 are interwoven in an up-and-down manner to form a support frame 655. In the first region 6553, the number of interlacing points of the first braided filament 6555 and the second braided filament 6556 is greater than the number of interlacing points in the second region 6554.

[0174] It should be noted that "overlapping" refers to the first braided yarn 6555 and the second braided yarn 6556 intersecting on one side and then wrapping around to the other side of the second braided yarn 6556. For example, in one embodiment, the second braided yarn 6556 includes a cross-section at the intersection point with the first braided yarn 6555: second braided yarn 6556a, second braided yarn 6556b, second braided yarn 6556c, and second braided yarn 6556d. The initial position of the first braided yarn 6555a is located below the second braided yarn 6556a, and the first braided yarn 6555a wraps around from the lower side of the second braided yarn 6556a to the upper side of the second braided yarn 6556b. Then, the first braiding thread 6555a passes over the upper side of the second braiding thread 6556b and the second braiding thread 6556c in sequence and wraps around to the lower side of the second braiding thread 6556c to achieve one interlacing. At this time, the first braiding thread 6555 wraps around from the lower side of the second braiding thread 6556 to the upper side of the second braiding thread 6556b and the second braiding thread 6556c and then wraps around to the lower side of the second braiding thread 6556d, which is an interlacing that crosses two second braiding threads 6556.

[0175] It is understood that the first braided yarn 6555 crosses at least two intersections with the second braided yarn 6556 to complete one interlacing. For example, in some embodiments, the first braided yarn 6555 may cross two, three, four, or five intersections with the second braided yarn 6556 to achieve one interlacing. It is understood that in other embodiments, the first braided yarn 6555 and the second braided yarn 6556 have interlacing points only at the start and end points; at positions other than the start and end points, all the first braided yarns 6555 are completely above or below the second braided yarn 6556 without any interlacing points.

[0176] The advantage of this arrangement is that the support frame 655 is formed by the interlacing of the first braided wire 6555 and the second braided wire 6556. In the first region 6553, the first braided wire 6555 crosses at least two intersections with the second braided wire 6556 to complete one interlacing. This allows the first braided wire 6555 to form a suspended section on one side of multiple second braided wires 6556. This reduces the number of interlacing points of the first braided wire 6555 and the second braided wire 6556 in the first region 6553, thereby reducing the constraint force between the first braided wire 6555 and the second braided wire 6556 in the first region 6553, improving the deformation capacity of the radial extension section, and reducing the probability of the radial extension section exerting excessive pressure on the first wall.

[0177] Example 6

[0178] The difference between this embodiment and Embodiments 2, 3, 4, and 5 is that, as Figures 33 to 35As shown, the elastic member 750 includes an axial main body portion 752 and an axial extension portion 753. The axial extension portion 753 communicates with the axial main body portion 752 and extends along the axial direction of the axial main body portion 752. An outlet 757 is opened on the axial extension portion 753.

[0179] The axial main body 752 is approximately cylindrical. After the valve prosthesis is implanted into the human body, the axial main body 752 is located at the valve and is secured to the valve annulus by radial force. The axial main body 752 has a certain degree of elasticity to adapt to the changes in the valve annulus shape during the heartbeat process. The axial main body 752 has a cavity-like structure.

[0180] The axial extension 753 is connected to the distal end of the axial main body 752 and extends along the distal direction of the axial main body 752. The axial main body 752 and the axial extension 753 are integrally connected. This integral connection means that the axial main body 752 and the axial extension 753 are integrally woven together by braiding or cut from a shape memory alloy. The axial main body 752 and the axial extension 753 together constitute an integral cavity structure in which blood can flow, so that the cavity structure can serve as a flow channel for blood. The axial extension 753 extends along the distal direction of the axial main body 752 such that at least a portion of the axial extension 753 is located on the side of the human valve annulus closer to the ventricle.

[0181] The axial extension 753 includes a circumferential surface 758 and a proximal surface 759. An outlet 757 is located on either the circumferential surface 758 or the distal surface. When the outlet 757 is located on the circumferential surface 758, it is positioned near the left ventricular outflow tract. When the outlet 757 is located on the proximal surface 759, it is positioned near the left ventricular outflow tract. After the valve prosthesis is implanted, during cardiac pulsation, blood flows sequentially through the through-hole and the flow port into the elastic element 750, and then sequentially through the axial main body 752 and the axial extension 753 before exiting through the outlet 757.

[0182] Therefore, the elastic element 750 includes an axial main body portion 752 and an axial extension portion 753. The axial extension portion 753 communicates with the axial main body portion 752 and extends along the axial direction of the axial main body portion 752. After the valve prosthesis is implanted into the human body, the axial extension portion 753 can be located on the lower side of the valve annulus. In this way, the axial extension portion 753 is not compressed by the first wall. Thus, when the axial main body portion 752 is subjected to excessive compression by the first wall, blood flow can pass through the axial extension portion 753, ensuring the smooth flow of blood in the flow channel. By opening the outlet 757 on the axial extension portion 753, the blood flow on the axial extension portion 753 can flow out from the outlet 757, avoiding blood stasis caused by the extension section and reducing the probability of thrombosis.

[0183] When the valve prosthesis is in operation, the outlet 757 is located on the side of the stent 710 closer to the left ventricular outflow tract. Consequently, the elastic element 750 deforms under the pressure of the heart, causing the blood within the deformed elastic element 750 to flow towards the outlet 757. Since the outlet 757 is located on the side of the stent 710 closer to the left ventricular outflow tract, blood flows from the outlet 757 towards the left ventricular outflow tract until it flows into the left ventricular outflow tract, thus facilitating blood flow out of the left ventricular outflow tract and promoting blood circulation.

[0184] like Figures 33 to 36 As shown, the proximal end face 759 of the axial extension 753 (i.e., the proximal end face 759 of the elastic member 750) is inclined relative to the axial direction of the bracket 710, and the proximal end face 759 is inclined toward the side near the outlet 757.

[0185] In one implementation, such as Figure 35 , Figure 36 As shown, the axial extension 753 includes a circumferential surface 758 and a proximal end surface 759. The circumferential surface 758 is arranged along the axial direction of the axial main body 752. The axial length x1 of the circumferential surface 758 on the side near the outlet 757 is greater than the axial length x2 on the side away from the outlet 757, that is, x1>x2. The axial length of the circumferential surface 758 increases from the side near the outlet 757 toward the side away from the outlet 757. The proximal end surface 759 and the circumferential surface 758... The sidewall is connected, and the proximal end face 759 is inclined relative to the axial main body 752, that is, the proximal end face 759 and the axial main body 752 have a certain angle. The proximal end face 759 is preset to have an angle α1 between 20° and 89°. Specifically, the angle between the proximal end face 759 and the axial main body 752 is 21°, 30°, 35°, 45°, 60°, 85° or 89°. The outlet 757 is opened on the circumferential surface 758 near the proximal end face 759 or near the circumferential surface 758.

[0186] Please return Figure 34 When the valve prosthesis is in working condition (i.e., after implantation), the blood flow away from the elastic outlet 757 flows into the elastic element 750 in direction f1. Then, under the guiding effect of the inclined proximal face 759, the blood flow flows and gathers towards the side closer to the outlet 757 (i.e., direction f2 in the attached figure), and then flows out from the outlet 757 in direction f3 in the figure.

[0187] In this way, by setting the proximal end face 759 of the axial extension 753 at an axial angle relative to the support 710, the proximal end face 759 is tilted towards the side near the outlet 757, so that the proximal end face 759 can guide the blood flow towards the side near the outlet 757, thereby achieving the guidance of blood flow and preventing blood flow from accumulating in the elastic member 750 and causing thrombus accumulation.

[0188] It is understood that, in another embodiment, such as Figure 37 , Figure 38 As shown, the proximal end face 859 is radially inclined relative to the bracket 810, and the proximal end face 859 is inclined toward the center of the elastic member 850.

[0189] It should be noted that the radial inclination of the proximal end face 859 relative to the bracket 810 refers to the inclination of the edge 8591 of the proximal end face 859 near the center of the elastic element 850 towards the center of the bracket 850, making the proximal end face 859 present as an inclined annular concave structure or an inclined annular convex structure. The radial direction of the proximal end face 859 and the bracket 810 has a certain included angle α2, which is between 30° and 60°. Specifically, the included angle α2 can be 30°, 40°, 45°, 50° or 60°.

[0190] For example, in one implementation, such as Figure 38 , Figure 39 As shown, the proximal face 859 has an inclined annular concave structure. The inclined annular concave structure means that the proximal face 859 is inclined from the side away from the outlet 857 towards the side closer to the outlet 857, and the proximal face 859 is inclined from the side away from the center of the elastic member 850 towards the side closer to the center of the elastic member 850. The edge 8591 of the proximal face 859 near the center of the elastic member 850 faces the proximal end of the stent 810. Thus, guided by the proximal face 859, the blood flow entering the elastic member 850 can be directed not only from the side away from the outlet 857 to the side closer to the outlet 857, but also from the side away from the center of the elastic member 850 to the side closer to the center of the elastic member 850, further promoting blood flow towards the side closer to the outlet 857.

[0191] For example, in another implementation, such as Figure 40As shown, the proximal face 859 presents an inclined annular convex structure. The inclined annular convex structure means that the proximal face 859 is inclined from the side away from the outlet 857 towards the side closer to the outlet 857, and the proximal face 859 is inclined from the side away from the center of the elastic member 850 towards the side closer to the center of the elastic member 850, with the edge 8591 of the proximal face 859 near the center of the elastic member 850 facing the distal end of the elastic member 850. Thus, guided by the proximal face 859, the blood flow entering the elastic member 850 can be directed not only from the side away from the outlet 857 to the side closer to the outlet 857, but also from the side closer to the center of the elastic member 850 to the side away from the center of the elastic member 850. This effectively guides the blood flow to the outlet 857, reducing the probability of blood reflux from the side away from the outlet 857 into the ventricle.

[0192] In this way, by setting the proximal end face 859 to be radially inclined relative to the support 810, and setting the proximal end face 859 toward the center of the elastic element 850, the proximal end face 859 can not only guide the blood flow in the axial direction, but also guide the blood flow in the radial direction, thereby promoting the guiding effect of blood flow in the elastic element 850 and further reducing the probability of blood flow stagnation in the elastic element 850 and forming thrombi.

[0193] It is understood that in this embodiment, the axial main body 852 may also include a first region near the left ventricular outflow tract 150 and a second region away from the left ventricular outflow tract 150. The arrangement of the support frame 855 and the sealing membrane 856 on the first and second regions of the axial main body 852 are the same as the arrangement direction of the support frame 855 in the first and second regions in Embodiments 4 and 5, and will not be described again here.

[0194] 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.

[0195] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A valve prosthesis, characterized in that, The device includes a support body and an elastic member disposed outside the support body. The support body has a through portion, and the elastic member is disposed along the circumference of the support body and surrounds the support body to form an annular cavity structure. The through portion communicates with the annular cavity structure. When the valve assembly of the valve prosthesis is in the closed state, blood can flow through the through-hole into the annular cavity structure formed by the elastic element and the support; when the valve assembly of the valve prosthesis is in the open state, the blood in the annular cavity structure flows back into the ventricle under the action of gravity.

2. The valve prosthesis according to claim 1, characterized in that, The elastic element has an outlet, and the annular cavity structure communicates with the outside through the outlet.

3. The valve prosthesis according to claim 2, characterized in that, The elastic element includes a connected axial main body and a radial extension, the radial extension extending radially outward along the axial main body, and the outlet is opened on the radial extension.

4. The valve prosthesis according to claim 3, characterized in that, When the valve prosthesis is in working condition, the radial extension is located on the side of the support body closer to the left ventricular outflow tract.

5. The valve prosthesis according to claim 3, characterized in that, The elastic element includes a support frame, the deformation performance of which is greater at the radial extension than at the axial main body.

6. The valve prosthesis according to claim 5, characterized in that, The support frame includes a first braided wire and a second braided wire. At the radial extension, the first braided wire and the second braided wire intersect and are movably connected. At the axial main body, the first braided wire and the second braided wire intersect and are fixedly connected.

7. The valve prosthesis according to claim 6, characterized in that, In the region where the radial extension is located, the first braided filament crosses at least two intersections with the second braided filament to complete one interlacing.

8. The valve prosthesis according to claim 5, characterized in that, The elastic element further includes an inner liner and an outer liner, the inner liner being located inside the support frame and the outer liner being located outside the support frame, the outlet being opened on the inner liner and / or the outer liner, and the support frame at the radial extension being movable relative to the inner liner and / or the outer liner.

9. The valve prosthesis according to claim 8, characterized in that, At the radial extension, the inner cladding and the outer cladding form a suspended section, within which the supporting frame can move.

10. The valve prosthesis according to claim 8, characterized in that, The inner cladding completely covers the inner wall of the support frame, the outer cladding only covers the area of ​​the support frame in the axial main body, and the support frame at the radial extension is exposed on the outside of the inner cladding.

11. The valve prosthesis according to claim 8, characterized in that, The outer membrane completely covers the outer wall of the support frame, the inner membrane only covers the area of ​​the support frame in the axial main body, and the support frame at the radial extension is exposed inside the outer membrane.

12. The valve prosthesis according to claim 5, characterized in that, The diameter of the wires in the radial extension of the supporting skeleton is smaller than that in the axial main body.

Images