Heart valve stent

Abstract

The application discloses a heart valve stent, which comprises connecting pieces, support pieces, positioning pieces and fastening pieces arranged between adjacent connecting pieces, the fastening pieces are used for fixing artificial heart valve leaflets, the positioning pieces are closer to the distal end of the heart valve stent than the support pieces, the fastening pieces are closer to the distal end of the heart valve stent than the positioning pieces, the distal ends of the support pieces and the positioning pieces are rods protruding towards the distal end of the heart valve stent, the support pieces are arranged on one side of native heart valve leaflets, and the positioning pieces are arranged on the other side of the native heart valve leaflets. The heart valve stent can effectively avoid the interference of the native heart valve leaflets on the artificial heart valve leaflets.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a heart valve stent. Background Technology

[0002] Because transcatheter aortic valve replacement (TAVR) surgery offers numerous advantages such as minimal invasiveness and rapid recovery, it is increasingly being used in various procedures. This has led to a shift in aortic valve replacement from open surgery to transcatheter procedures. Consequently, there is a need for a cardiac valve stent that is suitable for transcatheter aortic valve replacement, easy to fix, and provides secure fixation.

[0003] Chinese invention patent CN102413793B, entitled "Stent for Positioning and Anchoring of Valve Prosthesis at Implantation Site in Patient's Heart," discloses an expandable stent comprising multiple positioning arcs and multiple retaining arcs. The positioning arcs are formed within multiple pockets on the native heart valve and located on a first side of multiple native heart valve leaflets. The retaining arcs are configured to be located on a second side of the multiple native heart valve leaflets opposite to the first side. Each retaining arc is divided into multiple arm segments by multiple curved edges, and these arm segments interconnect to form retaining arc arms, which are straight when the stent is not expanded. Each arm of the retaining arc has a shape that matches the leaflet of the valve prosthesis to which the stent is attached.

[0004] However, in the existing heart valve stent disclosed in this technology, the native valve leaflet is directly clamped between the positioning element and the fastening arc, which poses a risk that the native heart valve leaflet may intrude into the artificial heart valve leaflet. Summary of the Invention

[0005] The purpose of this application is to provide a heart valve stent including a support member, thereby solving the technical problem in the prior art where the native heart valve leaflets may interfere with the artificial heart valve leaflets. Specifically, the heart valve stent described herein may include a support member, a positioning member, and a fastener. Both the support member and the positioning member protrude towards the distal end of the heart valve stent, thereby clamping the native heart valve leaflets between the support member and the positioning member, while the artificial heart valve leaflets are sutured to the fastener, so that the native heart valve leaflets and the artificial heart valve leaflets are physically completely separated, thereby preventing the native heart valve leaflets from interfering with the artificial heart valve leaflets.

[0006] To achieve the above objectives, the present invention provides the following technical solution.

[0007] In a first aspect, this application provides a heart valve stent, comprising a distal end of the heart valve stent near the apex of the heart when the heart valve stent is in an extended state and a proximal end of the heart valve stent away from the apex of the heart when the heart valve stent is in an extended state, characterized in that the proximal end of the heart valve stent includes a connector and a support, a positioning member and a fastener disposed between adjacent connectors, the fastener being used to fix the artificial heart valve leaflet; The support includes a first support arm, a second support arm, and a distal end of a support connecting the first support arm and the second support arm. The first support arm is fixedly connected to a first connector, and the second support arm is fixedly connected to a second connector. The first connector is adjacent to the second connector. The positioning component includes a first positioning arm, a second positioning arm, and a distal end of the positioning component connecting the first positioning arm and the second positioning arm. The first positioning arm is fixedly connected to a first connecting component, and the second positioning arm is fixedly connected to a second connecting component. The first connecting component is adjacent to the second connecting component. The fastener includes a first fastening arc, a second fastening arc, and a fastener distal end connecting the first fastening arc and the second fastening arc. The first fastening arc is fixedly connected to a first connector, and the second fastening arc is fixedly connected to a second connector. The first connector is adjacent to the second connector. The positioning member is closer to the distal end of the heart valve stent than the support member, and the fastener is closer to the distal end of the heart valve stent than the positioning member. The distal ends of the support member and the positioning member are rods protruding toward the distal end of the heart valve stent. The support member is located on one side of the original heart valve leaflet, and the positioning member is located on the other side of the original heart valve leaflet.

[0008] In one embodiment of the first aspect, when the heart valve stent is in a compressed state, the first support arm and the second support arm are linear.

[0009] In one embodiment of the first aspect, when the heart valve stent is in a compressed state, the first positioning arm and the second positioning arm are linear.

[0010] In one embodiment of the first aspect, the distal end of the positioning element has a parabolic structure.

[0011] In one embodiment of the first aspect, when the heart valve stent is in an extended state, the support member has a first opening angle, the positioning member has a second opening angle of 4-14°, and the first opening angle is smaller than the second opening angle.

[0012] In one embodiment of the first aspect, the vertical distance between the point closest to the distal end of the positioning member and the farthest point of the distal end of the heart valve stent is 4mm-8mm, preferably 6mm.

[0013] In one embodiment of the first aspect, the connector includes a connecting block, a connecting web, and a connecting frame. One end of the connecting block forms the proximal end of the heart valve stent, and the other end is connected to the connecting frame through the connecting web. Along the direction from the proximal end of the heart valve stent to the distal end of the heart valve stent, the connecting frame sequentially includes a support connecting portion, a positioning connecting portion, and a fastener connecting portion.

[0014] In one embodiment of the first aspect, the width of the connecting web is smaller than the width of the connecting block and smaller than the width of the support member connecting portion.

[0015] In one embodiment of the first aspect, the connecting frame includes a hollow, elongated stitching hole.

[0016] In one embodiment of the first aspect, the positioning member includes a pull wire composite ring fixedly connected to the positioning member and located on the side of the positioning member facing the proximal end of the heart valve stent. The pull wire composite ring includes a first through hole and a second through hole, the first through hole being used for mounting a marker, the second through hole being adapted to insert a pull wire, and the second through hole being closer to the proximal end of the heart valve stent than the first through hole.

[0017] In one embodiment of the first aspect, the diameter of the first through hole is larger than the diameter of the second through hole.

[0018] In one embodiment of the first aspect, the pull wire composite ring is disposed at the distal end of the positioning member and is inclined inward relative to the axis of the heart valve stent.

[0019] In one embodiment of the first aspect, the support member includes a support member pull loop adapted to insert a pull wire, the support member pull loop being fixedly connected to the distal end of the support member.

[0020] In one embodiment of the first aspect, the support member pull loop is fixedly connected to the outer side of the distal end of the support member.

[0021] In one embodiment of the first aspect, when the heart valve stent is in a compressed state, the position of the support member pull ring is aligned with the position of the pull ring composite ring in the axial direction of the heart valve stent.

[0022] In one embodiment of the first aspect, the support member pull ring is inclined outward relative to the support member, preferably, the angle of inclination of the support member pull ring relative to the support member is 100°-160°.

[0023] Compared with the prior art, the beneficial effects of this application are as follows: (1) The original heart valve leaflets are sandwiched between the support and the positioning component, so that the original heart valve leaflets and the artificial heart valve leaflets are physically completely separated, thereby avoiding the original heart valve leaflets from interfering with the artificial heart valve leaflets. (2) By setting up a pull wire composite ring and a support pull wire ring, the difficulty of clamping the original heart valve leaflet with the positioning and support components can be reduced, making the operation more convenient; (3) Since the original leaflet is held by the support and the positioning component, the clamping is relatively more secure. At the same time, the support also facilitates the heart valve stent to expand more smoothly, increasing the radial force when the stent expands. Attached Figure Description

[0024] The technical features and advantages of the present invention will be more fully understood by taking into account the accompanying drawings and the following detailed description.

[0025] Figure 1 A perspective view showing a heart valve stent in an extended state according to one embodiment of this application.

[0026] Figure 2 Display as shown Figure 1 The image shows a three-dimensional view of the heart valve stent from another angle.

[0027] Figure 3 Display as shown Figure 1 The diagram shows the unfolded form of a heart valve stent.

[0028] Figure 4 show Figure 3 A magnified view of a portion of region B in the middle.

[0029] Figure 5 show Figure 3 A magnified view of a portion of region C in the middle.

[0030] Figure 6 show Figure 1 The image shown is a three-dimensional view of a heart valve stent after the artificial heart valve leaflets have been installed and the stent is in an extended state.

[0031] Figure 7 show Figure 6 The top view of the 3D diagram shown.

[0032] Figure 8 A perspective view showing a heart valve stent in an extended state according to another embodiment of this application.

[0033] Figure 9 show Figure 8 The diagram shown includes a three-dimensional view of the heart valve stent during the wire pulling process. Detailed Implementation

[0034] Unless otherwise defined, the technical or scientific terms used in this specification and claims shall have the ordinary meaning as understood by one of ordinary skill in the art to which this invention pertains.

[0035] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0036] Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0037] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art will understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0038] As described herein, when referring to the heart valve stent, "proximal" refers to the side of the heart valve stent located in the extended state, either on the side of the delivery device or in the direction of the end operated by the user. Correspondingly, "distal" refers to the side of the heart valve stent located in the extended state, away from the delivery device or in the direction of the end operated by the user. In this application, when describing the heart valve stent, "proximal" refers to the side of the heart valve stent located closer to the apex when it is in the extended state. Correspondingly, "distal" refers to the side of the heart valve stent located away from the apex when it is in the extended state. Because the heart valve stent described herein is delivered via catheter through the aorta, "distal" and "proximal" refer to the same location, but this does not preclude implantation via the apex; this description uses the example of heart valve stent delivery via catheter through the aorta.

[0039] Example 1 This embodiment provides a cardiac valve stent, which will be referred to below. Figure 1-7 The cardiac valve stent of this embodiment is described in detail.

[0040] First refer to Figure 1-3 ,in Figure 1 This image shows a perspective view of the heart valve stent 1 in its extended state according to Embodiment 1. Figure 2 This shows a perspective view of the heart valve stent 1 according to this embodiment from another angle, and Figure 3 This shows an unfolded view of the cardiac valve stent 1 according to this embodiment. Figure 1-3 As shown, the heart valve stent 1 described in this embodiment may include a distal end of the heart valve stent near the apex of the heart when the heart valve stent is in the extended state, and a proximal end of the heart valve stent away from the apex of the heart when the heart valve stent is in the extended state. The proximal end of the heart valve stent may include a connector 14 and a support 11, a positioning member 12, and a fastener 13 disposed between adjacent connectors. The support 11 and the positioning member 12 can be used to fix the native heart valve leaflets, while the fastener 13 can be used to fix the artificial heart valve leaflets.

[0041] In this embodiment, the support member 11 may include a first support arm 111, a second support arm 112, and a distal end 113 connecting the first support arm 111 and the second support arm 112. The first support arm 111 is fixedly connected to a first connector, and the second support arm 112 is fixedly connected to a second connector, with the first connector adjacent to the second connector. Similarly, the positioning member 12 may include a first positioning arm 121, a second positioning arm 122, and a distal end 123 connecting the first positioning arm and the second positioning arm. The first positioning arm 121 is fixedly connected to the first connector, and the second positioning arm 122 is fixedly connected to the second connector, with the first connector adjacent to the second connector. Furthermore, the fastener 13 includes a first fastening arc 131, a second fastening arc 132, and a distal end 133 connecting the first fastening arc and the second fastening arc. The first fastening arc is fixedly connected to the first connector, and the second fastening arc is fixedly connected to the second connector, with the first connector adjacent to the second connector.

[0042] In this embodiment, the positioning member 12 is closer to the distal end of the heart valve stent than the support member 11, and the fastener 13 is closer to the distal end of the heart valve stent than the positioning member 12. The distal ends 113 and 123 of the support member and the positioning member are rods protruding toward the distal end of the heart valve stent. The support member 11 is disposed on one side of the original heart valve leaflet, and the positioning member 12 is disposed on the other side of the original heart valve leaflet.

[0043] Compared with traditional heart valve stents, the heart valve stent described in this article also includes a support member 11, which can clamp the original leaflet between the support member 11 and the positioning member 12. The support member 11 prevents the original leaflet from interfering with the artificial leaflet. Moreover, since the original leaflet is clamped by the support member and the positioning member, the clamping is relatively more secure. At the same time, the support member also facilitates the heart valve stent to expand more smoothly and increases the radial force during self-expansion.

[0044] In one specific implementation, reference is made to... Figure 3When the heart valve stent is in a compressed state, the first support arm and the second support arm are linear. Similarly, when the heart valve stent is in a compressed state, the first positioning arm and the second positioning arm are linear. The linear design of the first and second positioning arms facilitates compression, minimizing their space occupation during full compression, meaning adjacent first and second support arms will come close together during compression. Furthermore, the linear structure ensures that they will not interfere with each other during compression; therefore, the linearity of the first and second positioning arms is also intended to ensure they come close together without interference during compression. Additionally, this stent is cut from a single nickel-titanium tube, but it should be noted that any implantable material can be used. The linear design also facilitates processing, shortens the processing path, and reduces processing costs.

[0045] In one specific embodiment, the distal end of the positioning element has a parabolic structure, which reduces the contact stress between the positioning element and the sinus floor and prevents the valve annulus from rupturing.

[0046] In one specific embodiment, when the heart valve stent is in the extended state, the support member has a first opening angle, and the positioning member has a second opening angle, which is 4°-14°, preferably 6°, 8°, 10°, 12°, etc., and the first opening angle is smaller than the second opening angle. The positioning member 12 and the fastener 13 form a certain opening angle, which facilitates the positioning member 12 to capture the valve leaflet and reduces the difficulty of the operation. The positioning member 12 can be used to prevent the valve from shifting in the ventricular direction and to align the distal end of the artificial valve leaflet with the original valve leaflet, so as to restore the function of the original valve to the greatest extent, while keeping the artificial valve in the original position of the original valve. Therefore, the artificial valve effectively replaces the original valve, reduces the impact on blood flow, and reduces the occurrence of thrombosis. The setting of the second opening angle of 4°-14° allows the positioning member 12 and the fastener 13 to clamp the original valve, preventing the original valve from moving freely. At the same time, the original valve leaflet is closely attached to the stent, reducing paravalvular leakage.

[0047] In one specific embodiment, the vertical distance between the point closest to the distal end of the positioning member and the farthest point of the distal end of the heart valve stent (i.e., the locking end 16 described below) is 4mm-8mm, preferably 6mm.

[0048] In one specific implementation, the distal end of the locking end is outwardly expanded relative to the proximal end, and the angle of this outward expansion is 6°-14°. This outward expansion is necessary to prevent the heart valve stent from shifting towards the aorta, thus providing an anchoring effect. At the same time, an excessively large angle is avoided to prevent contact with the His bundle, which could affect the normal heartbeat and endanger life.

[0049] In one embodiment, the fastener 13 is wider than the support 11 and the positioning member 12 to provide strong support.

[0050] Next, the structure of the connector 14 in this embodiment will be described in more detail. Return to Figures 1-3 The connector 14 may include a connecting block 141, a connecting web 142, and a connecting frame 143. One end of the connecting block 141 forms the proximal end of the heart valve stent, and the other end is connected to the connecting frame 143 through the connecting web 142. The connecting block 141 is for connection with a delivery device for delivering the heart valve stent.

[0051] refer to Figure 3 Along the direction from the proximal end to the distal end of the heart valve stent, the connecting frame 143 may sequentially include a support connecting portion, a positioning connecting portion, and a fastener connecting portion. In one specific embodiment, the support connecting portion may be symmetrical, with one side connected to the first support arm of the first support member and the other side connected to the second support arm of the adjacent second support member. In a preferred embodiment, the upper edge of the connection between the support arm and the connecting frame is a smooth arc with an angle of 100°-160°. Simultaneously, the lower edge of the connection between the support arm and the connecting frame is also a smooth arc with an acute angle.

[0052] Back Figure 3The support arm of the support member includes point X. The first or second support arm bends at point X, and the deformation point is far from the connecting frame, reducing stress concentration. Because both the support member and the positioning member are connected to the connecting frame 143, and the space in the connecting frame 143 is limited, if the connecting parts of the support member and the positioning member in the connecting frame are very close together, and if the deformation positions of the support member relative to the connecting frame and the positioning member relative to the connecting frame are both at the connection point, and the support member and the positioning member are located on opposite sides of the valve, then if their deformation positions relative to the connecting frame are too close, it is easy to generate a large shear force on the original valve near the connecting frame, thereby damaging the valve. Furthermore, if the deformation areas are too close, stress concentration is also likely to occur, causing the connection between the support member / positioning member and the connecting frame to break. At this point, it is necessary to increase the distance between the two components relative to the deformation position of the connecting frame. Therefore, by increasing the cross-sectional area of ​​the support and the connecting frame while maintaining their streamlined shape, the stent can be easily released by the delivery device. The upper edge of the connection between the support arm and the connecting frame is a smooth arc with an angle of 100°-160°, and the lower edge of the connection between the support arm and the connecting frame is also a smooth arc with an acute angle. This is to form a stress concentration release arc with the lower positioning component and the connection frame, preventing the formation of stress concentration points that could cause breakage at the connection between the support / positioning component and the connecting frame. In the cardiac valve stent described in this paper, the deformation position of the support relative to the connecting frame is shifted to point X, which is far away from the connecting frame. This solves the problem of easily generating large shear forces on the native valve near the connecting frame. Moreover, the distance between the two deformation zones also prevents excessive stress concentration.

[0053] In one embodiment, the width of the connecting web is smaller than the width of the connecting block and smaller than the width of the support member connecting portion. In another embodiment, the connecting frame includes a hollow elongated suture hole 144. One end of the elongated suture hole 144 can be located in the support member connecting portion, and the other end can be located in the positioning member connecting portion or the fastener connecting portion. The elongated suture hole 144 allows the proximal edge of the artificial leaflet to be directly sutured through the suture hole without the need for additional suture pads. The edge of the artificial leaflet is sutured to the fastening arc. Compared with the traditional method of using pads and stents to compress and fix the leaflet, this suture method firstly reduces the external components of the stent, and the absence of pads also facilitates further compression of the stent. If there are pads, it will not only affect the compression of the stent, but may even damage the artificial leaflet when the stent is compressed to a small size.

[0054] In another embodiment, the positioning element may include a drawstring composite ring 124, which is fixedly connected to the positioning element and located on the side of the positioning element facing the proximal end of the heart valve stent. The drawstring composite ring includes a first through hole 1241 and a second through hole 1242. The first through hole is used to install a marker, and the second through hole is adapted to insert a drawstring, and the second through hole is closer to the proximal end of the heart valve stent than the first through hole. In one specific embodiment, the diameter of the first through hole is larger than the diameter of the second through hole. The drawstring composite ring structure at the distal end of the positioning element 12 combines the installation of the drawstring and the marker (the marker is not radiolucent) in one location, effectively reducing the product's space occupancy. Using a single location, the opening and closing control and positioning of the positioning element can be achieved, which not only improves the product's compressibility and facilitates delivery using a catheter, but also allows the positioning element to open, reducing the difficulty of surgical procedures. The suture-guided composite ring structure has two through holes. The larger hole is for placing a marker point to facilitate precise implantation and ensure the positioning device touches the sinus floor. The smaller hole facilitates the insertion of the suture. However, it should be noted that the smaller hole prevents the suture from wobbling within the hole, which could affect the accuracy of manipulating the positioning device. Therefore, it is preferred that the diameter of the suture hole be smaller than the diameter of the larger hole. However, it is not impossible for the diameter of the suture hole to be equal to or greater than the diameter of the larger hole. During implantation, the angle of the positioning device is controlled by the suture, facilitating leaflet capture and reducing the difficulty of the operation. In a preferred embodiment, the suture-guided composite ring is located at the distal end of the positioning device and is tilted inward relative to the axis of the heart valve stent. This prevents the proximal end of the suture-guided composite ring from colliding with the aortic wall during stent movement, which could damage the aorta and, in severe cases, lead to aortic dissection, threatening the user's life. The positioning device can then be pulled outward from the heart valve stent using the suture.

[0055] In one specific implementation, reference is made to... Figure 4 and Figure 5The distal end of the heart valve stent also includes a retaining end 16 and a reinforcing mesh 15, with a perforated structure 17 between the retaining end 16 and the reinforcing mesh 15. In this embodiment, the retaining end 16 has 18 rhomboid squares, effectively increasing the compressibility of the heart valve stent. Furthermore, the width of the bars forming the rhomboid squares is gradually changing (narrower in the middle and wider at both ends) to optimize the stent's fatigue resistance. In addition, because the heart valve stent described herein only includes 18 rhomboid squares, only one reinforcing mesh 15 is needed to connect the retaining end between adjacent fastening arcs, creating numerous perforated areas. This effectively reduces the weight of the heart valve stent and facilitates compression. The gradually changing width of the bars forming the rhomboid squares (narrower in the middle and wider at both ends) optimizes the stent's fatigue resistance and enhances the rebound effect of the retaining end, facilitating stent self-expansion. Furthermore, the presence of the reinforcing mesh 15 increases the structural strength of the central part of the stent and also isolates the autologous leaflet to prevent invasion of the artificial leaflet.

[0056] In the embodiment shown in the accompanying drawings, the heart valve stent may include three structurally identical support members, positioning members, fasteners, and connectors. Adjacent connectors are connected by the support members, positioning members, and fasteners. Simultaneously, adjacent support members, positioning members, and fasteners are connected by the connectors. When the heart valve stent is in its extended state, it is essentially cylindrical. The artificial heart valve leaflet can be sandwiched between the support members and positioning members, such as... Figure 6 and 7 As shown.

[0057] Example 2 The difference between Example 2 and Example 1 is that the support includes a support pull ring 114 suitable for threading a pull wire.

[0058] refer to Figure 8 and Figure 9 The support member pull ring 114 is fixedly connected to the support member and is located on the side of the support member facing the distal end of the heart valve stent. The description of the heart valve stent features in Embodiment 1 with reference to the accompanying drawings also applies to this embodiment, and will not be repeated here.

[0059] In one specific embodiment, when the heart valve stent is in a compressed state, the position of the support member pull loop is aligned with the position of the pull loop composite ring, parallel to the axial direction of the heart valve stent. In another specific embodiment, the support member pull loop is tilted outward relative to the support member, so that when clamping the original leaflet, the support member faces the original leaflet without damaging the artificial leaflet, while also serving to compress the original leaflet. Therefore, although... Figure 8 and Figure 9The distal end of the pull loop shown is rounded, but it can also be made pointed to pierce the original leaflet. It should be noted that in this embodiment, the support pull loop 114 is located on the outer side of the distal end of the support (towards the distal end of the heart valve stent). This is because if the support pull loop 114 is located on the inner side of the distal end of the support (towards the proximal end of the heart valve stent), it would obstruct the approach of the distal ends of the first support arm 111 and the second support arm 112, thus affecting the compressibility of the stent. However, placing the support pull loop 114 on the outer side of the distal end of the support... The inner side of the end allows the support member pull ring 114 to act as barbs, which can more reliably fix the original leaflet. Therefore, if the compressibility can be guaranteed, the support member pull ring 114 can also be set on the inner side of the distal end. Preferably, the support member pull ring is tilted outward at an angle α of 100°-160° relative to the support member, so that the support member pull ring is tilted outward relative to the axis of the support. This setting ensures that the support member pull ring will not interfere with the artificial leaflet. Moreover, at this time, the support member pull ring faces the valve, which can make the valve more reliably fixed between the support member and the positioning member.

[0060] The cardiac valve stent of this embodiment can reduce the difficulty of clamping the native leaflet between the positioning member and the support member in Embodiment 1. A pull wire ring is added to the distal end of the support member. The positioning member is controlled from the outside of the stent by one pull wire 3 and the support member is controlled from the inside of the stent by another pull wire 3. This causes the positioning member to open outward and the support member to bend inward, thereby creating a larger gap between the two, which makes it easier to clamp the native leaflet between the positioning member and the support member.

[0061] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

Claims

1. A heart valve stent, comprising a distal end of the heart valve stent near the apex of the heart when the heart valve stent is in an extended state, and a proximal end of the heart valve stent away from the apex of the heart when the heart valve stent is in an extended state, characterized in that, The proximal end of the heart valve stent includes a connector and a support, a positioning element and a fastener disposed between adjacent connectors, the fastener being used to fix the artificial heart valve leaflets; The support includes a first support arm, a second support arm, and a distal end of a support connecting the first support arm and the second support arm. The first support arm is fixedly connected to a first connector, and the second support arm is fixedly connected to a second connector. The first connector is adjacent to the second connector. The positioning component includes a first positioning arm, a second positioning arm, and a distal end of the positioning component connecting the first positioning arm and the second positioning arm. The first positioning arm is fixedly connected to a first connecting component, and the second positioning arm is fixedly connected to a second connecting component. The first connecting component is adjacent to the second connecting component. The fastener includes a first fastening arc, a second fastening arc, and a fastener distal end connecting the first fastening arc and the second fastening arc. The first fastening arc is fixedly connected to a first connector, and the second fastening arc is fixedly connected to a second connector. The first connector is adjacent to the second connector. Wherein, the positioning member is closer to the distal end of the heart valve stent than the support member, the fastener is closer to the distal end of the heart valve stent than the positioning member, the distal ends of the support member and the distal ends of the positioning member are rods protruding toward the distal end of the heart valve stent, the support member is disposed on one side of the original heart valve leaflet, and the positioning member is disposed on the other side of the original heart valve leaflet; The distal end of the positioning component has a parabolic structure; When the heart valve stent is in the extended state, the support has a first opening angle, the positioning member has a second opening angle, the second opening angle is 4°-14°, and the first opening angle is smaller than the second opening angle. The positioning element includes a pull wire composite ring, which is fixedly connected to the positioning element and located on the side of the positioning element facing the proximal end of the heart valve stent. The pull wire composite ring includes a first through hole and a second through hole. The first through hole is used to install a marker, and the second through hole is adapted to insert a pull wire. The second through hole is closer to the proximal end of the heart valve stent than the first through hole.

2. The cardiac valve stent as described in claim 1, characterized in that, When the heart valve stent is in a compressed state, the first support arm and the second support arm are linear.

3. The cardiac valve stent as described in claim 1, characterized in that, When the heart valve stent is in a compressed state, the first positioning arm and the second positioning arm are linear.

4. The cardiac valve stent as described in claim 1, characterized in that, The vertical distance between the point closest to the distal end of the positioning element and the farthest point of the distal end of the heart valve stent is 4mm-8mm.

5. The cardiac valve stent as described in claim 1, characterized in that, The connector includes a connecting block, a connecting web, and a connecting frame. One end of the connecting block forms the proximal end of the heart valve stent, and the other end is connected to the connecting frame through the connecting web. Along the direction from the proximal end of the heart valve stent to the distal end of the heart valve stent, the connecting frame sequentially includes a support connecting portion, a positioning connecting portion, and a fastener connecting portion.

6. The cardiac valve stent as described in claim 5, characterized in that, The width of the connecting web is smaller than the width of the connecting block and smaller than the width of the connecting portion of the support member.

7. The cardiac valve stent as described in claim 5, characterized in that, The connecting frame includes a hollow, elongated stitching hole.

8. The cardiac valve stent as described in claim 1, characterized in that, The diameter of the first through hole is larger than the diameter of the second through hole.

9. The cardiac valve stent as described in claim 1, characterized in that, The pull wire composite ring is located at the distal end of the positioning element and is inclined inward relative to the axis of the heart valve stent.

10. The cardiac valve stent as described in claim 1, 5, or 6, characterized in that, The support member includes a support member pull ring adapted to insert a pull wire, and the support member pull ring is fixedly connected to the distal end of the support member.

11. The cardiac valve stent as described in claim 10, characterized in that, The support member's pull ring is fixedly connected to the outer side of the far end of the support member.

12. The cardiac valve stent as described in claim 10, characterized in that, When the heart valve stent is in a compressed state, the position of the support wire loop is aligned with the position of the wire composite loop.

13. The cardiac valve stent as described in claim 10, characterized in that, The pull ring of the support member is tilted outward relative to the support member, and the outward tilt angle is 100°-160°.

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