Valve prosthesis

Abstract

The application discloses a valve prosthesis, which comprises an inner layer support, an outer layer support and an elastic piece. The inner layer support is arranged in the outer layer support and connected with the outer layer support. The two ends of the elastic piece are connected with the outer layer support and the inner layer support respectively. The inflow end of the inner layer support and the outflow end of the outer layer support are connected, and the inner wall of the outer layer support and the outer wall of the inner layer support are arranged at intervals, so that a certain deformation space is formed between the outer layer support and the inner layer support. Therefore, when the outer layer support is extruded and deformed, the outer layer support can be deformed in the deformation space, and the probability that the leaflet assembly is affected by the extrusion of the outer layer support on the inner layer support is reduced.

Description

Technical Field

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

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

[0003] 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 valves with prosthetic valves. Existing valve prostheses have a certain degree of elastic deformation to adapt to the heart's diastole and expansion. However, as the valve prosthesis moves with the heart's beat, the valve leaflets inside the prosthesis are easily subjected to excessive compression and deformation. Summary of the Invention

[0004] Therefore, it is necessary to provide a valve prosthesis, including an inner stent, an outer stent, and an elastic element, wherein the inner stent is inserted inside the outer stent, the inner stent and the outer stent are connected, the inner stent and the outer stent are spaced apart, and the two ends of the elastic element are respectively connected to the outer stent and the inner stent.

[0005] Optionally, one end of the elastic element is connected to the inflow section or intermediate section of the outer support, and the other end of the elastic element is connected to the outflow section of the inner support.

[0006] Optionally, at least part of the outflow section of the inner support is bent radially outward to form a flared structure, and the elastic element is connected to the flared structure.

[0007] Optionally, the elastic element includes a bonding portion that at least partially bonds with the outer support layer when the elastic element deforms.

[0008] Optionally, the fitting part has an arc-shaped structure, with the convex surface of the arc-shaped structure facing the inflow end and the concave surface of the arc-shaped structure facing the inflow end.

[0009] Optionally, the elastic element includes a first rod and a second rod connected to each other, the first rod and the second rod being arranged at a predetermined angle, one end of the first rod being connected to the outer layer support, the other end of the second rod being connected to the inner layer support, and the first rod forming the fitting portion.

[0010] Optionally, the valve prosthesis further includes a first cover, a second cover, and a third cover. The first cover covers the outer wall of the outer stent, the second cover covers the inner wall of the inner stent, the first cover and the second cover are connected at the outflow end of the inner stent, and the third cover is located between the inner stent and the outer stent and is connected to the first cover and the third cover, respectively. The third cover is located on the side of the elastic element near the outflow end.

[0011] Optionally, there are multiple elastic elements, all of which are arranged around the inner support, and the third coating covers all of the elastic elements.

[0012] Optionally, the area between the outer support and the inner support includes a first area and a second area that are circumferentially adjacent, and the distribution density of the elastic element in the first area is greater than the distribution density in the second area.

[0013] Optionally, the outer support includes a plurality of rhomboid skeletons arranged circumferentially, with adjacent rhomboid skeletons spaced apart, and the elastic element connected to the rhomboid skeletons.

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

[0015] This invention connects the inflow end of the inner support layer and the outflow end of the outer support layer. The inner wall of the outer support layer and the outer wall of the inner support layer are spaced apart, creating a certain deformation space between them. Therefore, when the outer support layer is compressed and deformed, it can deform within this space, reducing the probability of the outer support layer compressing the inner support layer and affecting the leaflet assembly. When the outer support layer is compressed and deformed, one end of an elastic element is connected to the outer support layer, and the other end is connected to the inner support layer. This allows the deformation force on the outer support layer to be partially offset by the elastic deformation of the elastic element, thereby reducing stress concentration at the connection point between the outer and inner support layers and preventing breakage at the connection point. Attached Figure Description

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

[0017] Figure 1 This is a schematic diagram of the valve prosthesis in Embodiment 1 of the present invention;

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

[0019] Figure 3 This is a schematic axial cross-sectional view of the valve prosthesis in Embodiment 1 of the present invention;

[0020] Figure 4 This is a schematic axial cross-sectional view of the valve prosthesis after valve assembly removal in Embodiment 1 of the present invention;

[0021] Figure 5 This is a schematic diagram of another embodiment of the elastic element and outer support in Embodiment 1 of the present invention;

[0022] Figure 6 For the present invention Figure 4 An enlarged structural diagram of one embodiment of the structure at point A in the diagram;

[0023] Figure 7 For the present invention Figure 4 An enlarged schematic diagram of another embodiment of the structure at point A;

[0024] Figure 8 This is a schematic diagram of the structure of the outer skeleton of the outer support in Embodiment 1 of the present invention, showing the spacing between the outer layers.

[0025] Figure 9 This is a schematic diagram of the connection structure of the inner frame of the inner support in Embodiment 1 of the present invention;

[0026] Figure 10 This is a schematic diagram of the film connection structure in Embodiment 2 of the present invention;

[0027] Figure 11 This is a schematic diagram showing the distribution of the elastic element in the first and second regions in Embodiment 2 of the present invention.

[0028] Figure label:

[0029] 100 - Valve prosthesis; 110 - Inner stent; 111 - First inflow segment; 112 - First intermediate segment; 113 - First outflow segment; 114 - First endoscaffold unit; 115 - Second endoscaffold unit; 120 - Outer stent; 121 - Second inflow segment; 122 - Second intermediate segment; 123 - Second outflow segment; 124 - First exoskeleton unit; 1241 - First strut; 1242 - Second strut; 1243 - Third strut; 1244 - Fourth strut; 125 - Second outer frame unit; 1251- Fifth rod; 1252- Sixth rod; 1253- Seventh rod; 1254- Eighth rod; 130- Elastic element; 131- Fitting part; 1311- Convex surface; 1312- Concave surface; 132- First rod; 133- Second rod; 141- Inflow end; 142- Outflow end; 150- Leaflet assembly; 161- First coating; 162- Second coating; 163- Third coating; 171- First region; 172- Second region. Detailed Implementation

[0030] 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.

[0031] 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.

[0032] In the field of interventional medical devices, "distal" is typically defined as the end furthest from the operator during surgery, and "proximal" as the end closest to the operator. In this invention, the valve prosthesis includes an open state and a closed state. When the valve prosthesis is in the open state, blood flow can pass through it; when it is in the closed state, blood flow cannot pass through it. In this invention, when the valve prosthesis is in a flow-through state, the end from which blood flows in is defined as the inflow end, and the end from which blood flows out is defined as the outflow end.

[0033] Example 1

[0034] This embodiment provides a valve prosthesis 100, which can be used to replace human valves, such as aortic valves, pulmonary valves, tricuspid valves, etc. 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.

[0035] like Figure 1 As shown, the valve prosthesis 100 includes an inner stent 110, an outer stent 120, and an elastic member 130. The inner stent 110 passes through the outer stent 120, and the outflow end of the inner stent 110 is connected to the outflow end of the outer stent 120. The inner wall of the outer stent 120 and the outer wall of the inner stent 110 are spaced apart (except at the connection).

[0036] The inner stent 110 has a tubular structure and can be made of shape memory metal, medical-grade stainless steel, or polymer materials. The inner stent 110 has a certain degree of elastic deformation; when compressed, it undergoes elastic deformation to adapt to the applied pressure. The inner stent 110 provides a connection point for the leaflet assembly 150, which is sutured to the inner stent 110. The leaflet assembly 150 is located inside the inner stent 110 and includes an open and a closed state. When the leaflet assembly 150 is in the open state, blood can pass through the inside of the inner stent 110. When the leaflet assembly 150 is in the closed state, it forms a blockage within the inner stent 110, making it difficult for blood to pass through. In this example, when the valve assembly is in the open state, the end of the valve prosthesis 100 where blood flows in is the inflow end 141; and the end where blood flows out is the outflow end 142.

[0037] like Figure 2 As shown, the outer stent 120 is located radially outside the inner stent 110, and the inner stent 110 passes through the outer stent 120. The inner wall of the outer stent 120 and the outer wall of the inner stent 110 are spaced apart except where they connect, with a certain distance x between them. The outflow end of the outer stent 120 is connected to the outflow end of the inner stent 110. The outer stent 120 can be made of shape memory metal, medical stainless steel, or polymer material. The outer stent 120 has a certain elastic deformation property; when the outer stent 120 is compressed, it undergoes elastic deformation to adapt to the compressive force. The diameter of the outer stent 120 is slightly larger than the diameter of the valve annulus. After the valve prosthesis 100 is implanted in the human body, the outer stent 120 conforms to the valve annulus and has a certain elastic force.

[0038] like Figure 3As shown, the sidewall of the outer support 120 is inclined relative to the sidewall of the inner support 110, and the sidewall of the outer support 120 and the sidewall of the inner support 110 have a certain angle α. The angle α between the sidewall of the outer support 120 and the sidewall of the inner support 110 is between 30° and 60°, specifically, the angle α can be 30°, 45°, 50° or 60°. The distance between the inner wall of the outer support 120 and the outer wall of the inner support 110 increases from the outlet end 142 towards the outlet end 142.

[0039] One end of the elastic element 130 is connected to the outer support 120, and the other end is connected to the inner support 110. The elastic element 130 is located between the outer support 120 and the inner support 110. When one end of the elastic element 130 is compressed, the elastic element 130 can elastically deform. Specifically, the elastic element 130 is made of an elastic material, which can be a shape memory alloy or elastic medical stainless steel. The elastic element 130 can be a rod-shaped element, and its two ends are welded to or integrally connected to the inner support 110 and the outer support 120, respectively. It should be noted that the integral connection in this embodiment refers to the inner support 110, the outer support 120, and the elastic element 130 being integrally cut from a shape memory material. The elastic element 130 can be horizontally arranged (i.e., along the radial direction of the inner support 110) or inclined relative to the inner support 110. After the valve prosthesis 100 is implanted in the human body, when the outer stent 120 moves toward the inner stent 110 due to the contraction force of the valve annulus, the outer stent 120 compresses the elastic element 130, the elastic element 130 undergoes elastic deformation and provides a certain support force for the outer stent 120, one end of the elastic element 130 moves toward the inner stent 110, the elastic element 130 bends and deforms to form an arc, and at the same time, transfers part of the compressive force on the outer stent 120 to the inner stent 110.

[0040] Therefore, by connecting the outflow end of the inner support 110 and the outflow end of the outer support 120, and by spacing the inner wall of the outer support 120 and the outer wall of the inner support 110 apart except at the connection point, a certain deformation space is provided between the outer support 120 and the inner support 110. Thus, when the outer support 120 is compressed and deformed, the outer support 120 can deform within this deformation space, reducing the probability that the outer support 120 will compress the inner support 110 and affect the leaflet assembly 150. When the outer support 120 is deformed under pressure, one end of the elastic element 130 is connected to the outer support 120, and the other end of the elastic element 130 is connected to the inner support 110. This allows the deformation force on the outer support 120 to be partially offset by the elastic deformation of the elastic element 130 and the deformation of the inner support 110, thereby dispersing the force on the outer support 120 at the valve annulus. This reduces the stress concentration at the connection node between the outer support 120 and the inner support 110 at the outflow end 142, preventing the outer support 120 and the inner support 110 from breaking at the connection point. In addition, it can increase the radial support force of the outer support 120 and improve the fit between the outer support 120 and the valve annulus.

[0041] like Figure 3 , Figure 4 As shown, the leaflet assembly 150 is connected to the inner support 110. The leaflet assembly 150 is located inside the inner support 110 and is located away from the position where the inner support 110 is connected to the elastic member 130.

[0042] The leaflet assembly 150 is sewn onto the inner wall of the inner support 110. The leaflet assembly 150 is connected to the elastic member 130 and the inner support 110 at a certain distance. Specifically, the leaflet assembly 150 can be set at a first position in the axial direction of the inner support 110, and the elastic member 130 is connected to the inner support 110 at a second position in the axial direction. The proximal end of the first position and the second position have a certain distance x2 in the axial direction.

[0043] Specifically, the inner support 110 includes a first inflow section 111, a first intermediate section 112, and a first outflow section 113. The first inflow section 111 is located at the inflow end of the inner support 110, the first outflow section 113 is located at the outflow end of the inner support 110, and the first intermediate section 112 is located between the inflow section and the outflow section. In one embodiment, the elastic member 130 is connected to the first inflow section 111, and the leaflet assembly 150 is connected to either the first intermediate section 112 or the first outflow section 113. In another embodiment, the elastic member 130 is connected to the first intermediate section 112, and the leaflet assembly 150 is connected to either the first inflow section 111 or the first outflow section 113. In yet another embodiment, the elastic member 130 is connected to the first outflow section 113, and the leaflet assembly 150 is connected to either the first inflow section 111 or the first intermediate section 112.

[0044] In this way, by setting the leaflet assembly 150 at a position away from the connection between the inner support 110 and the elastic member 130, there is a certain distance between the leaflet assembly 150 and the connection between the inner support 110 and the elastic member 130. When the deformation force of the outer support 120 is too large and is transmitted to the inner support 110 through the elastic member 130, the leaflet assembly 150 can avoid the deformation point of the inner support 110, thereby reducing the influence of the deformation of the inner support 110 on the leaflet assembly 150.

[0045] like Figure 4 As shown, one end of the elastic element 130 is connected to the middle section of the outer support 120, and the other end of the elastic element 130 is connected to the outflow section of the inner support 110. The leaflet assembly 150 is located in the middle section of the inner support 110.

[0046] The outer stent 120 includes a second inflow section 121, a second intermediate section 122, and a second outflow section 123 connected in sequence. The second inflow section 121 extends from the inflow end 141 toward the outflow end 142, and bends from the inflow end 141 toward a direction closer to the inner stent 110. The diameter of the second inflow section 121 gradually decreases from the inflow end 141 toward the outflow end 142. The radial projection of the second intermediate section 122 covers the first inflow section 111 and the first intermediate section 112. The second outflow section 123 is flush with the first outflow section 113. The outflow end 142 of the outer stent 120 is connected to the outflow end 142 of the inner stent 110. The leaflet assembly 150 is sutured to the first intermediate section 112. One end of the elastic element 130 is connected to the first intermediate section 112, and the other end is connected to the first outflow section 113. When the elastic element 130 is compressed by the outer support 120, the elastic element 130 deforms towards the outer support 120, increasing the contact area between the elastic element 130 and the outer support 120. After bending, the concave surface of the elastic element 130 faces the outflow end 142, and the convex surface faces the inflow end 141. The greater the deformation of the outer support 120 towards the inner support 110, the more bent the elastic element 130 becomes, the larger the contact area between the elastic element 130 and the outer support 120, and the stronger the interference of the elastic element 130 with the deformation of the outer support 120, thereby increasing the supporting capacity of the elastic element 130 towards the outer support 120. In another embodiment, the concave surface of the elastic element 130 may also face the inflow end 141, and the convex surface of the elastic element 130 may also face the outflow end 141.

[0047] In other implementations, such as Figure 5As shown, one end of the elastic member 130 is connected to the inflow section of the outer support 120, and the other end of the elastic member 130 is connected to the outflow section of the inner support 110. That is, one end of the elastic member 130 is connected to the second inflow section 121, and the other end of the elastic member 130 is connected to the first outflow section 113. Specifically, the elastic member 130 is connected to the flared structure of the first outflow section 113.

[0048] The advantage of this arrangement is that, by connecting one end of the elastic element 130 to the middle section of the outer support 120 and the other end of the elastic element 130 to the outflow section of the inner support 110, the elastic element 130 can be tilted relative to the outer support 120. When the outer support 120 deforms towards the inner support 110, the elastic element 130 can partially conform to the outer support 120. Furthermore, the greater the deformation of the outer support 120, the larger the contact area between the elastic element 130 and the outer support 120, thus strengthening the interference with the deformation of the outer support 120. By connecting the leaflet assembly 150 to the middle section of the inner support 110, the leaflet assembly 150 can avoid the connection point between the inner support 110 and the elastic element 130, thus avoiding the deformation point of the inner support 110 and reducing the impact of the deformation of the inner support 110 on the leaflet assembly 150.

[0049] The elastic member 130 is provided with a fitting part 131, which at least partially fits against the outer support 120 when the elastic member 130 is deformed.

[0050] For example, in one implementation, such as Figure 6 As shown, the elastic element 130 includes an arc-shaped rod with an arc structure. The arc-shaped rod is the contact portion 131 of the elastic element 130. The convex surface 1311 of the arc-shaped rod faces the inflow end 141, and the concave surface 1312 of the arc-shaped rod faces the inflow end 141. The greater the deformation of the outer support 120 towards the inner support 110, the more curved the elastic element 130 becomes, and the larger the contact area between the elastic element 130 and the outer support 120 becomes.

[0051] In another implementation, such as Figure 7As shown, the elastic element 130 includes a first arm 132 and a second arm 133, which are arranged at a predetermined angle. One end of the first arm 132 is connected to the inner support 110, and the other end of the first arm 132 is connected to the second arm 133. The second arm 133 is connected to the outer support 120, forming the contact portion 131. When the outer support 120 compresses the elastic element 130, the angle between the first arm 132 and the second arm 133 decreases, the angle between the second arm 133 and the outer support 120 decreases, and the contact area between the second arm 133 and the outer support 120 increases. The stronger the compressive force on the elastic element 130, the smaller the angle between the first arm 132 and the second arm 133, and the larger the contact area between the second arm 133 and the outer support 120, thus making the interference of the second arm 133 with the outer support 120 stronger.

[0052] In this way, by providing a fitting portion 131 on the elastic member 130, the fitting portion 131 will at least partially fit with the outer support 120 when the elastic member 130 deforms. The greater the deformation of the elastic member 130, the larger the fitting area between the elastic member 130 and the outer support 120, and the stronger the interference with the outer support 120, thus reducing the possibility of the outer support 120 squeezing the middle section.

[0053] like Figure 4 and Figure 5 As shown, the outflow section (i.e., the first outflow section 113) of the inner support 110 is at least partially bent radially outward to form a flared structure, and the elastic member 130 is connected to the flared structure.

[0054] The first outflow section 113 is bent radially outward to form a bent section, which has a flared structure in the circumferential direction. The diameter of the first outflow section 113 increases from near the middle section to near the outflow end 142. The end of the first outflow section 113 is connected to the end of the second outflow section 123. One end of the elastic element 130 is connected to the bent section of the first outflow section 113. The elastic element 130 can be welded to the first outflow section 113 or integrally connected. It should be noted that integral connection means that the elastic element 130 and the outflow section are integrally connected by laser cutting. The outflow section of the outer support 120 bends toward the inner support 110, the first outflow section 113 bends toward the outer support 120, the end of the outer support 120 is connected to the end of the inner support 110 to form an arc-shaped structure, the concave surface of the arc-shaped structure faces the inflow end 141, the convex surface of the arc-shaped structure faces the outflow end 142, and the end of the arc-shaped structure furthest from the inflow end 141 forms the outflow end 142.

[0055] In some embodiments, the curvature of the first outflow section 113 decreases from the position near the middle section towards the position near the outflow end 142. In this embodiment, the curvature of the first outflow section 113 refers to the fact that points on the first outflow section 113 at different positions have different curvature circles. The curvature is the reciprocal of the radius of the curvature circle, i.e., k = 1 / r, where k is the curvature and r is the radius of the curvature circle. The curvature represents the degree of bending of the first outflow section 113; the smaller the curvature, the less bending the outflow section; the larger the curvature, the more bending the first outflow section 113.

[0056] During the bending and deformation of the elastic element 130 under the pressure of the outer support 120, the elastic element 130 deforms and generates stress, which is transmitted to the first outflow section 113. The first outflow section 113 deforms towards the inner side of the inner support 110 under the stress of the elastic element 130. During the resetting process of the outer support 120, the elastic element 130 resets along with the outer support 120, and the first outflow section 113 resets along with the elastic element 130. In the axial cross-sectional view of the inner support 110, the first outflow section 113 bends radially outward, and the first intermediate section 112 is arranged axially. The first outflow section 113 and the first intermediate section 112 have a certain angle between 30° and 80°. Specifically, the angle between the first outflow section 113 and the first intermediate section 112 can be 30°, 45°, 50°, 60°, or 80°. When the elastic element 130 squeezes the outflow section, the first outflow section 113 can deform radially inward.

[0057] Therefore, by bending the first outflow section 113 radially outward, a flared structure is formed in the circumferential direction of the first outflow section 113. The flared structure is connected to the elastic member 130. When the elastic member 130 is squeezed by the outer support 120, on the one hand, the flared structure can deform radially inward to adapt to the stress applied by the elastic member 130 to the inner support 110. On the other hand, since the first outflow section 113 is bent radially outward, the flared structure and the first intermediate section 114 have a certain angle, so the flared structure has a certain space for radial inward deformation. When the first outflow section 113 deforms radially inward, the flared structure provides a certain deformation margin for the first outflow section 113, thereby preventing the first outflow section 113 from driving the first intermediate section 114 to deform radially inward, and avoiding deformation of the leaflet assembly 150 caused by the deformation of the first intermediate section 114.

[0058] like Figure 5As shown, the angle between the elastic element 130 and the first outlet section 113 is between 30° and 80°. The angle between the elastic element 130 and the first outlet section 113 refers to the angle between the elastic element 130 and the sidewall of the first outlet section 113. Specifically, the angle between the elastic element 130 and the first outlet section 113 can be 30°, 45°, 50°, 60°, or 80°.

[0059] The outer support 120 includes multiple outer frame units arranged circumferentially, with adjacent outer frame units spaced apart, and the elastic element 130 connected to the outer frame unit.

[0060] The outer support 120 includes multiple outer skeleton units. All outer skeleton units are connected to the outflow end 142 of the inner support 110. Two adjacent outer skeleton units are spaced apart in the circumferential direction. Two adjacent outer skeleton units have a certain distance between them in the circumferential direction and a certain partition space in the circumferential direction. Two adjacent outer skeleton units can deform or move within the partition space. The partition space isolates the force transmission between two adjacent outer skeleton units, so that the deformation of the two outer skeleton units will not interfere with each other.

[0061] For example, in one embodiment, the exoskeleton unit has a rhomboid structure. The multiple exoskeleton units include a first exoskeleton unit 124 and a second exoskeleton unit 125 that are circumferentially adjacent. The first exoskeleton unit 124 includes a first rod 1241, a second rod 1242, a third rod 1243, and a fourth rod 1244. The first rod 1241, the second rod 1242, the third rod 1243, and the fourth rod 1244 are connected end to end to form a rhomboid structure. The first rod 1241 and the second rod 1242 are connected to form a first vertex, the second rod 1242 and the third rod 1243 are connected to form a second vertex, the third rod 1243 and the fourth rod 1244 are connected to form a third vertex, and the fourth rod 1244 and the first rod 1241 are connected to form a fourth vertex. The second exoskeleton unit 125 includes a fifth rod 1251, a sixth rod 1252, a seventh rod 1253, and an eighth rod 1254. These rods are connected end-to-end to form a rhombus structure. The fifth rod 1251 and the sixth rod 1252 form the fifth vertex; the sixth rod 1252 and the seventh rod 1253 form the sixth vertex; the seventh rod 1253 and the eighth rod 1254 form the seventh vertex; and the eighth rod 1254 and the fifth rod 1251 form the eighth vertex. The second and sixth vertices are spaced apart, thus achieving an alternating arrangement between the first exoskeleton unit 124 and the second exoskeleton unit 125.

[0062] It is understood that in other implementations, the exoskeleton unit may also be a triangular structure, a pentagonal structure, or a rod-shaped structure.

[0063] like Figure 9 As shown, the inner skeleton includes multiple inner skeleton units arranged circumferentially, with adjacent inner skeleton units circumferentially connected. Adjacent inner skeleton units are fixedly connected circumferentially, either fixedly connected or integrally connected. Deformation stress between adjacent inner skeleton units can be transferred to each other. For example, in one embodiment, the inner skeleton units have a rhomboid structure, including a first inner skeleton unit 114 and a second inner skeleton unit 115 circumferentially adjacent. The first inner skeleton unit 114 has a first vertex 1141 and a second vertex 1142 circumferentially, and the second inner skeleton unit 115 has a third vertex 1151 and a fourth vertex 1152 circumferentially. The second vertex 1142 and the third vertex 1151 are adjacent and fixedly connected. The two ends of the elastic member 130 are connected to the inner skeleton and the outer skeleton, respectively.

[0064] Thus, by including multiple circumferentially spaced exoskeleton units in the outer stent 120, stress isolation spaces are created between adjacent exoskeleton units, preventing deformation of adjacent exoskeleton units from interfering with each other. This allows the outer stent 120 to better adapt to the heart's pulsation. Similarly, by including multiple circumferentially connected inner stent units in the inner stent 110, adjacent inner stent units can interfere with each other, resulting in better structural stability. This prevents the outer stent from pulling on the inner stent through the elastic element 130, ensuring the valve assembly 150 maintains structural stability.

[0065] Example 2

[0066] The difference between this embodiment and Embodiment 1 is that, as Figure 10As shown, the valve prosthesis 100 also includes a first cover 161, a second cover 162, and a third cover 163. The first cover 161 is disposed on the outer wall of the outer stent 120, and the second cover 162 is disposed on the inner wall of the inner stent 110. The first cover 161 and the second cover 162 are connected at the outflow end 142 of the inner stent 110. The third cover 163 is located between the inner stent 110 and the outer stent 120. The edge of the third cover 163 near the outer stent 120 is connected to the first cover 161, and the edge of the third cover 163 near the inner stent 110 is connected to the second cover 162. The first cover 161, the second cover 162, and the third cover 163 enclose a sealed cavity structure. The third cover 163 can be located on the side of the elastic member 130 near the inflow end 141, or it can be disposed on the side wall of the elastic member 130 near the inflow end. The sealed cavity structure formed by the first membrane 161, the second membrane 162, and the third membrane 163 is used to seal the area between the elastic element 130, the inner support 110, and the outer support 120 (especially the area of ​​the elastic element near the outflow end), to prevent blood from entering the area and forming a thrombus, and to hinder the deformation of the elastic element 130.

[0067] The first membrane 161 is connected to the outer wall of the outer support 120 and extends from the inflow end 141 of the outer support 120 toward the outflow end 142. The second membrane 162 is connected to the inner wall of the inner support 110 and extends from the inflow end 141 of the inner support 110 toward the outflow end 142. The first membrane 161 and the second membrane 162 are connected at the connection point of the outer support 120 and the inner support 110 at the outflow section. The first membrane 161 and the second membrane 162 can be sewn together or heat-pressed together. In other embodiments, the first cover 161 and the second cover 162 can be the same cover. For example, the cover extends from the outer wall of the outer support 120 and bypasses the outflow section to cover the inner wall of the inner support 110. In this way, the cover can simultaneously cover the outer wall of the outer support 120 and the inner wall of the inner support 110. The cover located on the outer wall of the outer support 120 is the first cover 161, and the cover located on the inner wall of the inner support 110 is the second cover 162. The first cover 161 can be sewn to the outer support 120 or heat-press bonded to it. The second cover 162 can be sewn to the inner support 110 or heat-press bonded to it.

[0068] The third coating 163 is located on the side of the elastic member 130 near the outflow section of the inner support 110. The third coating 163 is located between the inner support 110 and the outer support 120. The third coating 163 is circumferentially surrounding the inner support 110. The third coating 163 includes an inner edge and an outer edge. The outer edge of the third coating 163 refers to the edge of the third coating 163 away from the inner support 110, and the inner edge of the third coating 163 refers to the edge of the third coating 163 near the inner support. The outer edge of the third covering 163 is connected to the first covering 161, and the inner edge of the third covering 163 is connected to the second covering 162. The third covering 163 is sewn or heat-pressed to the first covering 161. The third covering 163 is sewn or heat-pressed to the second covering 162. The third covering 163, the second covering 162 and the first covering 161 enclose a sealed cavity structure, and the elastic element 130 is located inside the sealed cavity structure.

[0069] In this way, the first membrane 161 covers the outer wall of the outer stent 120, and the second membrane 162 covers the inner wall of the inner stent 110. The first membrane 161 and the second membrane 162 are connected at the outflow end 142 of the inner stent 110, so that the first membrane 161 and the second membrane 162 can cover the gap between the inner stent 110 and the outer stent 120, thereby sealing the gap between the inner stent 110 and the outer stent 120 and preventing blood from overflowing from the gap between the inner stent 110 and the outer stent 120, thus preventing paravalvular leakage. The third cover 163 is located on the side of the elastic element 130 near the outflow end 142 of the inner stent 110. The third cover 163 is connected to the first cover 161 and the second cover 162 respectively, so that the third cover 163, the second cover 162, and the first cover 161 form a closed space, thereby preventing blood from entering the closed space. By setting the third cover 163 on the side of the elastic element 130 away from the outflow end 142, the elastic element 130 can be accommodated in the closed space. After the valve prosthesis 100 is implanted in the human body, the elastic element 130 can deform in the closed space, maintaining the flexibility of the elastic element 130 deformation, and preventing the formation of cumulative thrombi in the space of the elastic element 130 near the outflow end 142 of the inner stent 110, which would interfere with the deformation of the elastic element 130.

[0070] There are multiple elastic elements 130, all of which are spaced around the inner stent 110. A third membrane 163 covers all the elastic elements 130. The multiple elastic elements 130 are spaced around the inner stent 110 circumferentially. The third membrane 163 covers all the elastic elements 130 and is attached to the side wall of the elastic element 130 near the inflow end 141. The third membrane 163 forms an isolation barrier on the side of the elastic element 130 near the inflow end 141 to prevent blood from entering the space between the elastic element 130 and the first membrane 161 and the second membrane 162 to form a cumulative thrombus.

[0071] It is understood that, in another embodiment, the third membrane 163 may also be disposed on the side of the elastic member 130 near the outlet end 142.

[0072] like Figure 11 As shown, the area between the outer support 120 and the inner support 110 includes a first region 171 and a second region 172 that are circumferentially adjacent, and the distribution density of the elastic element 130 in the first region 171 is greater than that in the second region 172.

[0073] It should be noted that the human valve annulus has a D-shaped structure, including a straight segment and an arc-shaped segment. After the valve prosthesis 100 is implanted into the human body, the first region 171 corresponds to the straight segment, and the second region 172 corresponds to the arc-shaped segment. In the straight segment, the compressive force on the outer stent 120 in the first region 171 is greater than the compressive force in the second region 172. The area between the outer stent 120 and the inner stent 110 refers to the space formed by the spaced outer stent 120 and the inner stent 110, within which the elastic element 130 is distributed.

[0074] The distribution density of the elastic element 130 refers to the number of elastic elements 130 per unit area. For example, in the top view of the valve prosthesis 100, let x1 be the axial projected area of ​​the first region 171 and x2 be the axial area of ​​the second region 172. Let a1 be the number of elastic elements 130 in the first region 171 and a2 be the number of elastic elements 130 in the second region 172. Then, the distribution density of the elastic element 130 in the first region 171 is D1 = a1 / x1; the distribution density of the elastic element 130 in the second region 172 is D2 = a2 / x2, where D1 > D2.

[0075] Thus, by including the first region 171 and the second region 172 that are circumferentially adjacent to each other in the outer support 120, the distribution density of the elastic element 130 in the first region 171 is greater than that in the second region 172, so that the support of the elastic element 130 in the first region 171 to the outer support 120 is greater than that in the second region 172. Therefore, it is possible to prevent the outer support 120 from being excessively compressed by the straight section, which would cause deformation of the middle section of the inner support 110.

[0076] 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.

[0077] 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 an inner support, an outer support, and an elastic element. The inner support is spaced through and connected to the outer support. The two ends of the elastic element are connected to the outer support and the inner support, respectively. The elastic element includes a fitting portion, and when the elastic element deforms, at least a portion of the fitting portion can fit against the outer support. The inner support provides a connection position for the leaflet assembly.

2. The valve prosthesis according to claim 1, characterized in that, One end of the elastic element is connected to the inflow section or middle section of the outer support, and the other end of the elastic element is connected to the outflow section of the inner support.

3. The valve prosthesis according to claim 2, characterized in that, The outflow section of the inner support is at least partially bent radially outward to form a flared structure, and the elastic element is connected to the flared structure.

4. The valve prosthesis according to claim 1, characterized in that, The fitting part has an arc-shaped structure, with the convex surface of the arc-shaped structure facing the inflow end and the concave surface of the arc-shaped structure facing the outflow end.

5. The valve prosthesis according to claim 1, characterized in that, The elastic element includes a first rod and a second rod connected to each other, the first rod and the second rod being arranged at a predetermined angle, the end of the first rod away from the second rod being connected to the outer support, the end of the second rod away from the first rod being connected to the inner support, and the first rod forming the fitting portion.

6. The valve prosthesis according to claim 1, characterized in that, The valve prosthesis further includes a first cover, a second cover, and a third cover. The first cover is disposed on the outer wall of the outer stent, the second cover is disposed on the inner wall of the inner stent, the first cover and the second cover are connected at the outflow end of the inner stent, and the third cover is located between the inner stent and the outer stent and is connected to the first cover and the second cover, respectively. The first cover, the second cover, and the third cover form a sealed cavity structure, which is used to prevent blood flow from entering the area between the elastic element, the inner stent, and the outer stent.

7. The valve prosthesis according to claim 6, characterized in that, The elastic element is multiple, all of which are arranged around the inner support, and the third coating is provided on the inflow side of all the elastic elements.

8. The valve prosthesis according to claim 7, characterized in that, The area between the outer support and the inner support includes a first area and a second area that are circumferentially adjacent, and the distribution density of the elastic element in the first area is greater than that in the second area.

9. The valve prosthesis according to claim 1, characterized in that, The outer support includes multiple rhomboid skeletons arranged circumferentially, with adjacent rhomboid skeletons spaced apart, and the elastic element connected to the rhomboid skeletons.

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