Valve prosthesis

Abstract

The application relates to the technical field of medical devices, and provides a valve prosthesis, which comprises a stent and a bag arranged on the stent; the stent comprises an extension body which can be located on one side of a heart valve ring, and the side of the extension body opposite to the heart valve ring is an outer side; the bag is located on the outer side of the extension body; wherein the bag has an opening through which blood can enter. Through the technical scheme, the valve prosthesis can better fit the heart valve ring, thereby solving the problem of paravalvular leakage.

Description

TECHNICAL FIELD

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

[0002] Mitral stenosis or regurgitation is one of the common valve diseases. Due to congenital abnormalities or acquired lesions, the mitral valve cannot completely close during left ventricular contraction, causing part of the blood flowing from the left atrium into the left ventricle to flow back to the left atrium, resulting in a series of pathological changes and clinical symptoms of the heart, and in severe cases, can lead to heart failure and even death.

[0003] Most of the existing mitral replacement stents are in the shape of a cylinder. After anchoring, the radial support force provided by the elasticity of the stent itself is used for support. However, the tissue structure of the mitral valve and the annulus in the human heart is asymmetric, and there are individual differences. It is difficult for the mitral replacement stent to maintain good adhesion under the condition of large differences, resulting in the problem of paravalvular leakage of the mitral replacement stent. SUMMARY

[0004] The technical problem to be solved by the present application is to provide a valve prosthesis that improves the adhesion to the heart valve annulus, thereby solving the problem of paravalvular leakage.

[0005] To solve the above technical problems, the present application adopts the following technical solutions:

[0006] The present application provides a valve prosthesis, comprising: a stent and a bag body arranged on the stent; the stent comprises an extension body that can be located on one side of the heart valve annulus, and the side opposite to the heart valve annulus of the extension body is the outer side; the bag body is located on the outer side of the extension body; wherein the bag body has an opening through which blood can enter.

[0007] In the implementation process of the above technical solution, the stent comprises an extension body that can be located on one side of the heart valve annulus after anchoring, and the bag body is located on the outer side of the extension body. When the stent is installed in place, the bag body is between the extension body and the heart valve annulus, and the bag body has an opening through which blood can enter. In this way, after the valve prosthesis is anchored, blood enters the bag body through the opening and gradually thrombosis fills in the bag body, further filling the gap between the stent and the heart valve annulus, improving the adhesion between the valve prosthesis and the heart valve annulus, and reducing the problem of paravalvular leakage.

[0008] Furthermore, the bag body filled between the extension body and the heart valve annulus has good adhesion, and can fill different amounts of blood according to the size of the gap between the stent and the heart valve annulus, thereby improving the adaptability of the stent.

[0009] As an implementation form, the extension body comprises a plurality of first positioning units arranged along the circumference of the stent; and the bag body is located outside the plurality of first positioning units.

[0010] In the implementation process of the above technical solution, the plurality of first positioning units are arranged along the circumference of the stent to improve the stability between the stent and the heart valve annulus; meanwhile, the bag body is located outside the plurality of first positioning units, so that the bag body is in an unfolded state and has a ring structure, and when there is a gap between the valve prosthesis and the heart valve annulus after the valve prosthesis is anchored, blood can enter the bag body.

[0011] As an implementation form, each first positioning unit comprises two first positioning rods, and the two first positioning rods in the same first positioning unit form a first connection point; and the bag body is located outside the plurality of first connection points.

[0012] In the implementation process of the above technical solution, the two first positioning rods in the same first positioning unit are connected to form a first connection point, so that the circumference of the stent has a plurality of first connection points, thereby improving the stability between the stent and the heart valve annulus; meanwhile, the bag body is located outside the plurality of first connection points, so that the bag body extends along the radial direction of the extension body, the length of the bag body in the radial direction is extended, the area of the bag body capable of plugging the gap is improved, and the problem of paravalvular leakage is further reduced.

[0013] As an implementation form, the two first positioning rods in the two adjacent first positioning units adjacent to each other meet at a first node at one end in the downstream direction, and the bag body is located outside the first node.

[0014] In the implementation process of the above technical solution, the two first positioning rods in the two adjacent first positioning units adjacent to each other meet at a first node at one end in the downstream direction, thereby improving the stability of the stent structure; in addition, the bag body is located outside the plurality of first nodes, thereby improving the coverage area of the bag body and reducing the problem of paravalvular leakage.

[0015] As an implementation form, the bag body comprises a first layer and a second layer, the first layer is connected with the stent, and the second layer has a free edge portion; and the free edge portion forms an opening of the bag body.

[0016] In the implementation process of the above technical solution, the bag body is provided as a first layer and a second layer, wherein the second layer is located outside the first layer in the radial direction of the stent, the first layer is connected with the stent to satisfy the stability between the bag body and the stent, and the second layer has a free edge portion to form an opening of the bag body, thereby facilitating blood to enter the bag body.

[0017] As an implementation form, the free edge part is located at the opposite end of the connecting position of the second layer and the first layer, and the free edge part is the entire edge of the second layer.

[0018] In the implementation process of the above technical solution, the free edge part is located at the opposite edge of the connecting position of the second layer and the first layer, and the free edge part is located at the entire edge of the second layer, so that the blood can enter the bag body from the periphery, and the problem of paravalvular leakage is reduced.

[0019] As an implementation form, the support body is connected with the extension body, the support body defines a flow channel for blood circulation, the extension body further includes a plurality of second positioning units, the plurality of second positioning units are arranged along the circumferential direction of the support body, each second positioning unit includes two second positioning rods, the two second positioning rods in the same second positioning unit are connected to form a second connecting point at the end away from the flow channel, and the first layer is connected with the second connecting point.

[0020] In the implementation process of the above technical solution, the support body is connected with the extension body, the support body defines a flow channel for blood circulation, the extension body further includes a plurality of second positioning units, the plurality of second positioning units are arranged along the circumferential direction of the support body, each second positioning unit includes two second positioning rods, the two second positioning rods in the same second positioning unit are connected to form a second connecting point at the end away from the flow channel, so as to improve the stability between the support and the heart valve ring; the first layer is further connected with the second connecting point, which further improves the stability between the bag body and the support, and facilitates the blood to enter the bag body.

[0021] As an implementation form, the support body is connected with the extension body, the support body defines a flow channel for blood circulation, the extension body extends outward along the radial direction of the support body, and the bag body is connected with the support body.

[0022] In the implementation process of the above technical solution, the bag body is connected with the support body, and since the bag body has a free edge part, the bag body can be located outside the extension body to make the blood enter the bag body.

[0023] As an implementation form, the bag body is a high polymer film or a textile cloth.

[0024] In the implementation process of the above technical solution, the bag body is a high polymer film or a textile cloth, which is convenient for sewing or bonding with the support, and at the same time, the high polymer film or the textile cloth can also play a role in stopping blood flow, so that the blood entering the bag body reduces blood flow, the blood gradually coagulates to form a thrombus, and plays a role in plugging.

[0025] As an implementation form, the support body comprises a plurality of first support units, each of the first support units comprises a first support rod and a second support rod, and two second positioning rods in the same second positioning unit are connected with the first support rod and the second support rod in two adjacent first support units respectively.

[0026] In the implementation process of the above technical solution, the support body comprises a plurality of first support units, each of the first support units comprises a first support rod and a second support rod, and two second positioning rods in the same second positioning unit are connected with the first support rod and the second support rod in two adjacent first support units respectively, so that the stent is in a hollow state, facilitating blood flow; at the same time, the stability of the stent is improved.

[0027] As an implementation form, the first support rod and the second support rod are connected at one end in the upstream direction to form a third connection point; and one end in the downstream direction of the second support rod in one of the two adjacent first support units is merged with one end in the downstream direction of the first support rod in the other first support unit at the third connection point.

[0028] In the implementation process of the above technical solution, the first support rod and the second support rod are connected at one end in the upstream direction to form a third connection point, thereby improving the structural stability of the stent; and one end in the downstream direction of the second support rod in one of the two adjacent first support units is merged with one end in the downstream direction of the first support rod in the other first support unit at the third connection point, thereby improving the structural stability of the stent.

[0029] As an implementation form, the support body further comprises a plurality of third support rods in an arc structure, two adjacent third support rods are separated by one first support unit, and both ends of each third support rod are connected with the third connection point.

[0030] In the implementation process of the above technical solution, the third support rod is arranged in an arc structure, facilitating expansion or contraction of the stent, two adjacent third support rods are separated by one first support unit, and both ends of each third support rod are connected with the third connection point, so as to improve the stability of the stent.

[0031] As an implementation form, the support body further comprises a plurality of second support units arranged along the circumference of the support frame; each of the second support units comprises a fourth support rod and a fifth support rod, and the fourth support rod and the fifth support rod are connected at one end thereof in the downstream direction to form a fourth joint; in the two adjacent second support units, one end of the fourth support rod in the upstream direction in one of the second support units and one end of the fifth support rod in the upstream direction in the other of the second support units are respectively connected to the two ends of the third support rod.

[0032] In the implementation process of the above scheme, the support body further comprises a plurality of second support units arranged along the circumference of the support frame, so that the support frame has a hollow structure; each of the second support units comprises a fourth support rod and a fifth support rod, and the fourth support rod and the fifth support rod are connected at one end thereof in the downstream direction to form a fourth joint; in the two adjacent second support units, one end of the fourth support rod in the upstream direction in one of the second support units and one end of the fifth support rod in the upstream direction in the other of the second support units are respectively connected to the two ends of the third support rod, thereby improving the stability of the overall structure of the support frame.

[0033] As an implementation form, the support frame further comprises an abutting body for abutting against the heart tissue, and the abutting body comprises a connecting portion located on the radial outer side of the support body and connected to the support body; the support body is provided with a first connecting hole, and the connecting portion is provided with a second connecting hole; the valve prosthesis further comprises a first connecting member for penetrating the first connecting hole and the second connecting hole, and a second connecting member for connecting the first connecting hole and the third support rod.

[0034] In the implementation process of the above scheme, the abutting body can be matched with the extension body to abut the inner and outer sides of the heart valve ring respectively, thereby improving the stability between the stent and the heart valve ring; the abutting body comprises a connecting portion located on the radial outer side of the support main body and connected with the support main body, the support main body is provided with a first connecting hole, and the connecting portion is provided with a second connecting hole, so that the first connecting member can connect the abutting body and the support main body, thereby improving the structural strength of the stent; the second connecting member can connect the first connecting hole and the third support rod together, thereby further improving the structural stability of the stent; on the other hand, the extension body is arranged on the radial outer side of the support main body, the stent is arranged in a double-layer stent structure, the abutting body can be released first when the valve prosthesis is released, at this time, the support main body has not been completely released, the position of the abutting body can be adjusted according to the actual situation, the abutting point of the abutting body is positioned on the inner side of the heart valve ring, and then the support main body is released to complete the release of the stent. In this way, before the abutting body is released, the sheath tube enters the target position, and the valve prosthesis does not need to be released after the position of the sheath tube is accurately positioned, but only needs to be released into the ventricular region on the inner side of the heart valve ring, after the abutting body is released, the position of the sheath tube is fine-tuned to position the abutting point of the abutting body on the inner side of the heart valve ring, and then the support main body can be directly released, the accuracy of positioning the first connecting point and the abutting point on the outer side and the inner side of the heart valve ring can be improved, the positioning difficulty of the valve prosthesis is reduced, and the operation convenience is improved.

[0035] As an implementation manner, the abutting body further comprises a plurality of first abutting units for abutting the heart tissue, and the plurality of first abutting units are arranged along the circumference of the support main body; each first abutting unit comprises two first abutting rods, and the two first abutting rods in the same first abutting unit are connected at the edge of the abutting body to form an abutting point for abutting the heart tissue; and adjacent two first abutting rods in adjacent two first abutting units meet at a fifth junction point at one end in the downstream direction.

[0036] In the implementation process of the above scheme, the abutting body further comprises a plurality of first abutting units for abutting the heart tissue, and the plurality of first abutting units are arranged along the circumference of the support main body, thereby improving the stability between the stent and the heart tissue; each first abutting unit comprises two first abutting rods, and the two first abutting rods in the same first abutting unit are connected at the edge of the abutting body to form an abutting point for abutting the heart tissue, thereby realizing multi-point positioning of the abutting body and the heart tissue, and the structure is simple and the positioning stability is high. BRIEF DESCRIPTION OF DRAWINGS

[0037] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the embodiments of the present application will be briefly introduced as follows. It should be understood that the following drawings only show some of the embodiments of the present application, and therefore should not be regarded as a limitation on the scope, and for those skilled in the art, other related drawings can also be obtained without creative labor on the basis of these drawings.

[0038] Figure 1 A structural schematic diagram of a valve prosthesis provided by the embodiments of the present application is shown in the figure.

[0039] Figure 2 A structural schematic diagram of a valve prosthesis provided by the embodiments of the present application is shown in the figure.

[0040] Figure 3 A structural schematic diagram of a valve prosthesis provided by the embodiments of the present application is shown in the figure.

[0041] Figure 4 A structural schematic diagram of a valve prosthesis provided by the embodiments of the present application is shown in the figure.

[0042] Figure 5 A structural schematic diagram of a valve prosthesis provided by the embodiments of the present application is shown in the figure.

[0043] Figure 6 A structural schematic diagram of a valve prosthesis provided by the embodiments of the present application is shown in the figure.

[0044] Figure legend: 1- extension body; 11- first positioning unit; 111- first positioning rod; 112- first connecting point; 113- first node; 12- second positioning unit; 121- second positioning rod; 122- second connecting point; 123- second node; 13- first support unit; 131- first support rod; 132- second support rod; 133- third connecting point; 134- third node; 135- third support rod; 14- second support unit; 141- fourth support rod; 142- fifth support rod; 143- fourth node; 2- abutting body; 21- connecting part; 211- second connecting hole; 22- first abutting unit; 221- first abutting rod; 222- abutting point; 223- fifth node; 3- bag body; 31- opening; 32- first layer; 33- second layer. DETAILED DESCRIPTION

[0045] The technical solutions in the embodiments of the present application will be described in combination with the drawings in the embodiments of the present application.

[0046] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. Furthermore, in the description of this application, terms such as "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0047] like Figure 1 , 2 As shown in Figures 5 and 6, embodiments of this application provide a valve prosthesis, including a stent and a pocket 3 disposed on the stent. The stent includes an extension 1 that can be positioned on one side of the heart valve annulus after anchoring. The pocket 3 is located outside the extension 1. When the stent is installed in place, the pocket 3 is positioned between the extension 1 and the heart valve annulus, and the pocket 3 has an opening 31 that allows blood to enter. Thus, after the valve prosthesis is anchored, blood will enter the pocket 3 through the opening 31, the flow rate will slow down, and blood will gradually thrombose and fill the pocket 3, further filling the gap between the stent and the heart valve annulus, improving the fit between the valve prosthesis and the heart valve annulus, and reducing the problem of paravalvular leakage.

[0048] Optionally, the outer side of the extension body 1 refers to the outer surface of the extension body 1, that is, the outer peripheral side of the extension body 1 located radially outward.

[0049] Optionally, the pocket 3 is filled between the extension body 1 and the heart valve annulus, which has good fit. Depending on the size of the gap between the stent and the heart valve annulus, different amounts of blood can be injected, thus improving the adaptability of the stent.

[0050] Optionally, the opening 31 of the bag body 3 can be formed in a circumferential circle, or several openings 31 can be spaced out along the circumferential circle.

[0051] Optionally, the bag 3 can be sewn onto the stent, or in some cases, it can be covered onto the surface of the stent by means of a film.

[0052] Optionally, the material of the bag body 3 can be a polymer film or non-woven fabric.

[0053] Optionally, a portion of the bag body 3 can be fixed to the support body instead of the outside of the extension body 1, and the bag body 3 has a free edge. Therefore, the bag body 3 can be located on the outside of the extension body 1 even if it is not fixed to the outside of the extension body 1. Of course, as a preferred embodiment, the bag body 3 can be fixed to the outside of both the support body and the extension body 1 to improve the stability between the bag body 3 and the support.

[0054] Optionally, the direction of blood flow can be defined as upstream and downstream, with the upstream direction being the outer side of the heart valve annulus and the downstream direction being the inner side of the heart valve annulus.

[0055] As shown in Figure 1 and 5 , as an embodiment, the extension body 1 comprises a plurality of first positioning units 11, the plurality of first positioning units 11 are arranged along the circumference of the stent, realizing multi-point positioning of the stent, so as to improve the stability between the stent and the heart valve annulus; at the same time, the bag body 3 is located outside the plurality of first positioning units 11, so that the bag body 3 is in an unfolded state and has an annular structure, and when there is a gap between the valve prosthesis and the heart valve annulus after the valve prosthesis is anchored, it is convenient for blood to enter the bag body 3.

[0056] Optionally, the bag body 3 can be connected with the plurality of first positioning units 11, so as to improve the stability between the bag body 3 and the extension body 1.

[0057] As shown in Figure 1 , as an embodiment, each first positioning unit 11 comprises two first positioning rods 111, the two first positioning rods 111 in the same first positioning unit 11 are connected to form a first connection point 112, so that the circumference of the stent is formed with a plurality of first connection points 112, improving the stability between the stent and the heart valve annulus; at the same time, the bag body 3 is located outside the plurality of first connection points 112, so that the bag body 3 extends along the radial direction of the extension body 1, extending the length of the bag body 3 in the radial direction, improving the area of the bag body 3 capable of plugging the gap, and further reducing the problem of paravalvular leakage.

[0058] Optionally, the bag body 3 can be connected with the plurality of first connection points 112, improving the stability between the bag body 3 and the extension body 1, and reducing the position of the bag body 3 at the first connection point 112 in a free state, so as to facilitate blood to enter the bag body 3 to form thrombus.

[0059] Optionally, the bag body 3 can be connected to a certain section of the extension body 1 or the entire extension body 1.

[0060] As shown in Figure 1 , as an embodiment, the adjacent two first positioning rods 111 in the adjacent two first positioning units 11 meet at a first junction point 113 at one end in the downstream direction, so as to improve the stability of the stent structure, in addition, the bag body 3 is located outside the plurality of first junction points 113, also improving the coverage area of the bag body 3, reducing the problem of paravalvular leakage.

[0061] Optionally, the bag body 3 can be connected with the first junction point 113, improving the stability between the bag body 3 and the stent.

[0062] As shown in Figure 2 , 5As shown in Figure 6, in one embodiment, the bag body 3 is configured as a first layer 32 and a second layer 33, wherein the second layer 33 is located outside the first layer 32 along the radial direction of the support, the first layer 32 is connected to the support to satisfy the stability between the bag body 3 and the support, and the second layer 33 has a free edge portion, thereby forming an opening 31 in the bag body 3 to facilitate blood entering the bag body 3.

[0063] Optionally, the first layer 32 is connected to the first node 113, the first connection point 112, and the first positioning unit 11. The first layer 32 and the second layer 33 can be two independent layered structures, that is, the first layer 32 is sewn to the second layer 33 at the opposite edge of the free edge of the second layer 33, and the connecting edge of the first layer 32 and the second layer 33 can also be connected to multiple first connection points 112. Of course, the bag body 3 can also be integrally formed, that is, the first layer 32 and the second layer 33 are a whole structure.

[0064] In one implementation, the free edge portion is located at the opposite edge of the connection between the second layer 33 and the first layer 32, and the free edge portion is located at the entire edge of the second layer 33, thereby facilitating blood to enter the bag body 3 from all sides and reducing the problem of perivalvular leakage.

[0065] Optionally, if the bag body 3 is a one-piece structure, the free edge of the second layer 33 is located at the opposite edge where the second layer 33 and the first layer 32 form a bent edge; if the first layer 32 and the second layer 33 are two independent structures, the free edge is located at the opposite edge where the first layer 32 and the second layer 33 are connected.

[0066] like Figure 3 As shown, in one embodiment, the stent includes a support body connected to an extension body 1. The support body encloses a flow channel for blood circulation. The extension body 1 also includes multiple second positioning units 12, which are arranged circumferentially along the support body. Each second positioning unit 12 includes two second positioning rods 121. The two second positioning rods 121 in the same second positioning unit 12 are connected at the end away from the flow channel to form a second connection point 122, thereby improving the stability between the stent and the heart valve annulus. The first layer 32 is connected to the second connection point 122, further improving the stability between the bag body 3 and the stent, and also facilitating blood entry into the bag body 3.

[0067] Optionally, the first connection point 112 protrudes from the second connection point 122 in a direction away from the flow channel. On the one hand, this allows the stent to form multiple support points that contact the heart tissue in the radial direction, thereby improving the stability of the stent and the heart tissue. On the other hand, it can also allow the bag body 3 to have multiple connection positions in the radial direction, thereby improving the stability between the bag body 3 and the stent.

[0068] As a parallel embodiment, the stent further comprises a support body connected with the extension body 1, and the bag body 3 is connected with the support body. In the embodiment, the bag body 3 only needs to be connected with the support body, but not with the extension body 1, so that the bag body 3 can be located outside the extension body 1, so that the blood enters the bag body 3.

[0069] Optionally, the support body is integrally formed with the extension body 1 to meet the structural strength of the stent.

[0070] As an embodiment, the bag body 3 is a high polymer film or a textile cloth, which is convenient to sew or bond with the stent. At the same time, the high polymer film or the textile cloth can also play a role in stopping the blood flow, so that the blood entering the bag body 3 reduces the blood flow, so that the blood gradually coagulates to form a thrombus, and plays a role in plugging.

[0071] As shown in Figure 3 As an embodiment, the support body comprises a plurality of first support units 13, each first support unit 13 comprises a first support rod 131 and a second support rod 132, and the two second positioning rods 121 in the same second positioning unit 12 are respectively connected with the first support rod 131 and the second support rod 132 in the adjacent two first support units 13, so that the stent is in a hollow state, which is convenient for blood flow; at the same time, the stability of the stent is also improved.

[0072] As shown in Figure 3 Optionally, the two first positioning rods 111 of the first positioning unit 11 and the two second positioning rods 121 of the second positioning unit 12 in the same extension direction meet at the second node 123 at one end in the downstream direction, thereby further improving the structural strength of the stent.

[0073] As shown in Figure 3 As an embodiment, the first support rod 131 and the second support rod 132 are connected at one end in the upstream direction to form a third connection point 133, thereby improving the structural stability of the stent; and one end in the downstream direction of the second support rod 132 in one of the two adjacent first support units 13 meets one end in the downstream direction of the first support rod 131 in the other first support unit 13 at a third node 134, thereby improving the structural stability of the stent.

[0074] As shown in Figure 4As shown, as an embodiment, the third support rods 135 are arranged in an arc structure, facilitating the expansion or contraction of the stent, and two adjacent third support rods 135 are separated by a first support unit 13, and the two ends of each third support rod 135 are connected to the third joint 134, so as to improve the stability of the stent.

[0075] As shown in Figure 4 As an embodiment, the support body further comprises a plurality of second support units 14, which are arranged along the circumference of the stent, so that the stent has a hollow structure, and each second support unit 14 comprises a fourth support rod 141 and a fifth support rod 142, and the ends of the fourth support rod 141 and the fifth support rod 142 in the downstream direction are connected to form a fourth joint 143; in two adjacent second support units 14, the end of the fourth support rod 141 in the upstream direction in one of the second support units 14 and the end of the fifth support rod 142 in the upstream direction in the other second support unit 14 are respectively connected to the two ends of the third support rod 135, which also improves the stability of the overall structure of the stent.

[0076] As shown in Figure 1 , 2 As an embodiment, the stent further comprises an abutting body 2 for abutting with the heart tissue, and the abutting body 2 can cooperate with the extending body 1 to abut the inner and outer sides of the heart valve annulus respectively, thereby improving the stability between the stent and the heart valve annulus; the abutting body 2 comprises a connecting portion 21 located on the radial outer side of the support body and connected to the support body, the support body is provided with a first connecting hole, and the connecting portion 21 is provided with a second connecting hole 211, so that the first connecting member can connect the abutting body 2 and the support body, thereby improving the structural strength of the stent; the second connecting member can connect the first connecting hole and the third support rod 135 together, thereby further improving the structural stability of the stent; on the other hand, by arranging the extending body 1 on the radial outer side of the support body, the stent is arranged in a double-layer stent structure, so that when the valve prosthesis is released, the abutting body 2 can be released first, and at this time the support body has not been completely released, and the position of the abutting body 2 can be adjusted according to the actual situation, so that the abutting point 222 of the abutting body 2 is positioned on the inner side of the heart valve annulus, and then the support body is released to complete the release of the stent. In this way, before the abutting body 2 is released, the sheath tube enters the target position, and the position of the sheath tube does not need to be accurately positioned before the valve prosthesis is released, but only needs to be released into the ventricular region on the inner side of the heart valve annulus, and after the abutting body 2 is released, the position of the sheath tube is fine-tuned to position the abutting point 222 of the abutting body 2 on the inner side of the heart valve annulus, and then the support body can be directly released, and the accuracy of positioning the first connecting point 112 and the abutting point 222 on the outer side and the inner side of the heart valve annulus can be improved, thereby reducing the positioning difficulty of the valve prosthesis and improving the convenience of operation.

[0077] Optionally, the support body and the abutment body 2 can be rigidly connected or flexibly connected. For example, the first connecting member can be a rivet or a screw, which passes through the first connecting hole and the second connecting hole 211 to rigidly connect the support body and the abutment body 2; or the first connecting member is a pull wire or a soft rope, which is tied and tightened by passing through the first connecting hole and the second connecting hole 211 to flexibly connect the support body and the abutment body 2. Of course, the first connecting member can be determined according to actual conditions.

[0078] Optionally, the second connecting member can be a pull wire or a soft rope, which can pass through the first connecting hole and be wound around the third support rod 135 to connect the support body and the third support rod 135.

[0079] Optionally, the abutment body 2 arranged on the radial outer side of the support body can also serve to clamp the first layer 32.

[0080] Optionally, in some cases, the first layer 32 can also be connected with the abutment body 2.

[0081] As shown in FIGS. Figure 1 , 2 and 5, as an embodiment, the abutment body 2 further comprises a plurality of first abutment units 22 for abutting the heart tissue, the plurality of first abutment units 22 are arranged along the circumference of the support body to improve the stability between the stent and the heart tissue; each first abutment unit 22 comprises two first abutment rods 221, the two first abutment rods 221 in the same first abutment unit 22 are connected at the edge of the abutment body 2 to form an abutment point 222 for abutting the heart tissue, realizing multi-point positioning of the abutment body 2 and the heart tissue, which is simple in structure and high in positioning stability.

[0082] Optionally, the abutment body 2 can abut the inner side of the heart valve annulus.

[0083] Optionally, the two adjacent first abutment rods 221 in the two adjacent first abutment units 22 converge at a fifth junction point 223 in the downstream direction, the abutment body 2 further comprises a second abutment unit, the second abutment unit comprises two second abutment rods, the edge of the first layer 32 can be fixed on the second abutment rods to improve the stability between the bag body 3 and the stent; the two ends of the two second abutment rods in the upstream direction respectively converge at the fifth junction point 223, and the ends in the downstream direction converge and connect to form a connecting portion 21.

[0084] The above merely provides an example of the present application and is not intended to limit the protection scope of the present application. Any modification, equivalent replacement, improvement, etc. made within the technical scope disclosed by the present application should be included in the protection scope of the present application.

[0085] The above merely provides an example of the present application and is not intended to limit the protection scope of the present application. Any modification, equivalent replacement, improvement, etc. made within the technical scope disclosed by the present application should be included in the protection scope of the present application.

[0086] It should be noted that the relative terms such as first and second, etc. are merely used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply that there is any such actual relationship or order between these entities or operations. Moreover, the terms "include", "contain" or any other variant thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements not only includes those elements, but also includes other elements not explicitly listed or inherent to such process, method, article or device. Without more limitations, the element defined by the statement "including a" does not exclude the presence of other identical elements in the process, method, article or device including the element.

Claims

1. A valve prosthesis, characterized in that, The bracket includes an extension body which can be located on one side of the heart valve ring, and the other side of the extension body opposite to the heart valve ring is the outer side; the bag body is located on the outer side of the extension body; wherein the bag body has an opening through which blood can enter; The extension body includes a plurality of first positioning units arranged along the circumference of the bracket; The bag body is located on the outer side of the plurality of first positioning units; the bag body includes a first layer and a second layer, the first layer is connected with the bracket, and the second layer has a free edge portion; the free edge portion forms the opening of the bag body; the second layer is located on the outer side of the first layer in the radial direction of the bracket; The bracket includes a support body connected with the extension body, the support body defines a flow channel for blood flow, and the extension body extends outward in the radial direction of the support body; the bag body is connected with the support body.

2. The valve prosthesis of claim 1, wherein, Each first positioning unit includes two first positioning rods, and the two first positioning rods in the same first positioning unit form a first connection point; the bag body is located on the outer side of a plurality of first connection points.

3. The valve prosthesis of claim 2, wherein, The adjacent two first positioning rods in the adjacent two first positioning units converge at a first node at one end in the downstream direction, and the bag body is located on the outer side of the first node.

4. The valve prosthesis of claim 1, wherein, The free edge portion is located at the opposite end of the connection position between the second layer and the first layer, and the free edge portion is the entire edge of the second layer.

5. The valve prosthesis of claim 4, wherein, The bracket includes a support body connected with the extension body, the support body defines a flow channel for blood flow, and the extension body further includes a plurality of second positioning units arranged along the circumference of the support body, each second positioning unit includes two second positioning rods, and the two second positioning rods in the same second positioning unit are connected to form a second connection point at one end away from the flow channel, and the first layer is connected with the second connection point.

6. The valve prosthesis of any of claims 1 to 5, characterized in that The bag body is a high polymer film or a textile cloth.

7. The valve prosthesis of claim 5, wherein, The support body includes a plurality of first support units, each first support unit includes a first support rod and a second support rod, and the two second positioning rods in the same second positioning unit are respectively connected with the first support rod and the second support rod in the adjacent two first support units.

8. The valve prosthesis of claim 7, wherein, The first support rod and the second support rod are connected to form a third connection point at one end in the upstream direction; one end in the downstream direction of the second support rod in one of the adjacent two first support units converges with one end in the downstream direction of the first support rod in the other first support unit at a third node.

9. The valve prosthesis of claim 8, wherein, The support body further includes a plurality of arc-shaped third support rods, adjacent two third support rods are separated by one first support unit, and both ends of each third support rod are connected with the third node.

10. The valve prosthesis of claim 9, wherein, The support body further comprises a plurality of second support units arranged along the circumference of the stent; each of the second support units comprises a fourth support rod and a fifth support rod, and the ends of the fourth and fifth support rods in the downstream direction are connected to form a fourth joint; the end of the fourth support rod of one of the two adjacent second support units in the upstream direction and the end of the fifth support rod of the other second support unit in the upstream direction are respectively connected to the two ends of the third support rod.

11. The valve prosthesis of claim 9, wherein, The stent further comprises an abutting body for abutting the heart tissue, and the abutting body comprises a connecting portion located on the radial outside of the support body and connected to the support body; The support body is provided with a first connecting hole, and the connecting portion is provided with a second connecting hole; The valve prosthesis further comprises a first connecting member for penetrating the first connecting hole and the second connecting hole, and a second connecting member for connecting the first connecting hole and the third support rod.

12. The valve prosthesis of claim 11, wherein, The abutting body further comprises a plurality of first abutting units for abutting the heart tissue, and the plurality of first abutting units are arranged along the circumference of the support body; Each of the first abutting units comprises two first abutting rods, and the two first abutting rods in the same first abutting unit are connected at the edge of the abutting body to form an abutting point for abutting the heart tissue; the two adjacent first abutting rods in the two adjacent first abutting units are connected at the ends in the downstream direction to form a fifth joint.

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