CN115381597A

CN115381597A - Stay wire composite ring and self-expansion heart valve stent comprising same

Info

Publication number: CN115381597A
Application number: CN202210657572.1A
Authority: CN
Inventors: 吴明明; 王春光; 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Koka Nantong Lifesciences Co Ltd
Priority date: 2022-03-28
Filing date: 2022-06-10
Publication date: 2022-11-25
Also published as: CN116849870A; CN115105259B; CN219000725U; CN218792637U; CN218356471U; CN219000720U; CN116807684A; CN115624416A; CN218356470U; CN117752468A; CN117752467A; CN115670750A; CN116849869A; CN218356472U; CN116869705A; CN219332099U; WO2023184639A1; CN115105259A; CN116807686A; CN218792636U

Abstract

The invention discloses a pull wire composite ring fixedly connected to a heart valve stent, which comprises a connecting plate fixedly connected with the heart valve stent and a through hole suitable for a pull wire to pass through, and the pull wire composite ring is configured to be identifiable under X rays. The present application also relates to a self-expanding heart valve stent comprising a pull-wire composite ring as described above. The stay wire composite ring does not comprise a mounting hole for mounting a marker, and the self-expanding heart valve stent is developed by arranging an X-ray-impermeable layer and a high-density metal layer on a connecting plate of the stay wire composite ring or setting the outer contour of the connecting plate of the stay wire composite ring into a specific shape, so that the marker can be prevented from flowing into a human body, and the safety of a user can be guaranteed. In addition, the pull wire composite ring described herein can facilitate the operation of the positioning member and reduce the difficulty of the operation.

Description

Stay wire composite ring and self-expansion heart valve stent comprising same

Technical Field

The invention relates to the technical field of medical instruments, in particular to a stay wire composite ring and a self-expansion heart valve stent comprising the same.

Background

Since the way of performing surgery via a catheter has many advantages such as less trauma and fast recovery, more and more surgeries are beginning to be performed via a catheter. Aortic valve replacement was also changed from the earlier surgical approach to transcatheter aortic valve replacement. In performing the surgery, it is necessary to accurately identify the position of the self-expanding heart valve stent, and thus, it is necessary to develop the self-expanding heart valve stent.

In addition, self-expanding heart valve stents typically include positioning members for positioning the self-expanding heart valve stent and fasteners for sutured fixation of the prosthetic valve leaflets, which require adjustment of the positioning members during delivery of the self-expanding heart valve stent.

The distal end of the traditional positioning piece is provided with a marker (the marker is radiopaque), and although the marker is convenient to position and implant the stent to a certain extent, the marker is at risk of falling off. If the "marker" falls off and then flows with the blood into other organs, this will seriously affect the safety of the user.

Disclosure of Invention

The present application is directed to a compound stay ring with a developing function and a self-expanding arc including the same, thereby solving the technical problems of the prior art. In particular, the pull wire composite ring described herein does not include mounting holes for mounting a marker and is configured to be identifiable under X-rays and can be used to accurately position a self-expanding heart valve stent. In addition, the stay wire composite ring can also comprise a through hole suitable for the stay wire to pass through, and the positioning piece is adjusted.

In order to achieve the above object, the present invention provides the following technical solutions.

In a first aspect, the present application provides a pull wire composite ring fixedly attached to a heart valve stent, characterized in that the pull wire composite ring comprises a connecting plate for fixed attachment to the heart valve stent and a through hole adapted for a pull wire to pass through, and is configured to be identifiable under X-ray.

In one embodiment of the first aspect, the connecting plate includes a fixed end and a free end, the fixed end of the connecting plate is fixedly connected with the heart valve support, and the free end of the connecting plate is inclined inward along the axis of the heart valve support.

In one embodiment of the first aspect, the through hole is provided at a free end of the connection plate.

In one embodiment of the first aspect, the surface of the connection plate is provided with an X-ray opaque marker layer or a high-density metal plating.

In one embodiment of the first aspect, the external profile of the connecting plate is configured in one or more of a gourd shape, a triangular shape, a circular shape, a diamond shape, or a cat-claw shape.

In a second aspect, the present application provides a self-expanding heart valve stent characterized in that it comprises a pull-wire composite ring as described in the first aspect.

In one embodiment of the second aspect, the self-expanding heart valve stent comprises a distal end of the self-expanding heart valve stent which is close to the apex of the heart when the heart valve stent is in the expanded state and a proximal end of the self-expanding heart valve stent which is far from the apex of the heart when the heart valve stent is in the expanded state, and the proximal end of the heart valve stent comprises connecting pieces and positioning pieces and fastening pieces which are arranged between adjacent connecting pieces, wherein the fastening pieces are used for fixing the artificial heart valve leaflets. In this embodiment, the positioning element includes a first positioning arm, a second positioning arm, and a positioning element distal end connecting the first positioning arm and the second positioning arm, the first positioning arm is fixedly connected to a first connecting element, the second positioning arm is fixedly connected to a second connecting element, and the first connecting element is adjacent to the second connecting element. In this embodiment, the fastener includes a first fastening arc fixedly connected to a first connector, a second fastening arc fixedly connected to a second connector, and a fastener distal end connecting the first fastening arc and the second fastening arc, the first connector adjacent to the second connector. In this embodiment, the pull wire composite ring is fixedly attached to the distal end of the positioning member.

In an embodiment of the second aspect, the connecting member includes a connecting block, a connecting web, and a connecting frame, one end of the connecting block forms the proximal end of the anti-regurgitation heart valve stent, and the other end of the connecting block is connected to the connecting frame through the connecting web, and the connecting frame sequentially includes a positioning member connecting portion and a fastening member connecting portion along a direction from the proximal end of the anti-regurgitation heart valve stent to the distal end of the anti-regurgitation heart valve stent.

In one embodiment of the second aspect, the width of the connecting web is smaller than the width of the connecting piece.

In one embodiment of the second aspect, the connecting frame comprises a hollow elongated suture hole.

In one embodiment of the second aspect, the self-expanding heart valve holder further comprises a support member disposed between adjacent connectors, the support member comprising a first support arm fixedly connected to a first connector, a second support arm fixedly connected to a second connector, and a support member distal end connecting the first support arm and the second support arm, the first connector being adjacent to the second connector.

In the embodiment that the self-expanding heart valve stent comprises a support, the connecting piece comprises a connecting block, a connecting web and a connecting frame, one end of the connecting block forms the near end of the anti-backflow heart valve stent, the other end of the connecting block is connected with the connecting frame through the connecting web, and the connecting frame sequentially comprises a support connecting part, a positioning piece connecting part and a fastener connecting part along the direction from the near end of the anti-backflow heart valve stent to the far end of the anti-backflow heart valve stent.

In one embodiment of the second aspect, the first and second fastening arches of the fastener include fastening arch concave portions and fastening arch convex portions when the self-inflating heart valve stent is in the expanded state. The fastening arc concave part is an arc-shaped rod-shaped structure which is convex towards the direction far away from the self-expanding heart valve support and is simultaneously convex towards the proximal end of the self-expanding heart valve support. The fastening arc projection portion is an arc-shaped rod-like structure that projects toward the self-expanding heart valve stent and simultaneously projects toward the distal end of the self-expanding heart valve stent. In this embodiment, the proximal end of the fastening arc concave portion is connected to the connecting member, the distal end of the fastening arc concave portion is fixedly connected to the fastening arc convex portion, and the distal end of the fastening arc convex portion is connected to the adjacent fastening arc convex portion through the distal end of the fastening member.

Compared with the prior art, the beneficial effect of this application lies in: the stay wire composite ring does not comprise a mounting hole for mounting a marker, but the self-expanding heart valve stent is developed by arranging an X-ray-opaque layer and a high-density metal layer on a connecting plate of the stay wire composite ring or setting the outer contour of the connecting plate of the stay wire composite ring into a specific shape, so that the marker can be prevented from flowing into a human body, and the safety of a user is guaranteed. In addition, the pull wire composite ring described herein can facilitate the operation of the positioning member and reduce the difficulty of the operation.

Drawings

The technical features and advantages of the present invention are more fully understood by referring to the following detailed description in conjunction with the accompanying drawings.

FIG. 1 shows a perspective view of a self-expanding heart valve stent in an expanded state according to one embodiment of the present application.

Fig. 2 shows a partial enlarged view of the area a in fig. 1.

Fig. 3 shows a guyed composite ring according to another embodiment.

Fig. 4 shows a guyed composite ring according to another embodiment.

Fig. 5 shows a guyed composite ring according to another embodiment.

Fig. 6 shows a guyed composite ring according to another embodiment.

FIG. 7 shows a deployed view of the self-inflating heart valve stent of FIG. 1.

Fig. 8 shows a partial enlarged view of the region B in fig. 7.

Fig. 9 shows a partial enlarged view of the region C in fig. 7.

FIG. 10 shows a perspective view of a self-inflating heart valve stent in an expanded state according to another embodiment of the present application.

FIG. 11 shows a deployment view of the self-inflating heart valve stent of FIG. 10

Fig. 12 shows a partial enlarged view of the region D in fig. 11.

Fig. 13 shows a partial enlarged view of the region E in fig. 11.

FIG. 14 shows a perspective view of a self-inflating heart valve stent in an expanded state according to another embodiment of the present application.

Fig. 15 shows a partial enlarged view of the region F in fig. 14.

Fig. 16 shows a perspective view illustrating a fastening arc according to another embodiment of the present application.

Detailed Description

Unless otherwise defined, technical or scientific terms used in the present specification and claims should have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like, indicate orientations or positional relationships based on those shown in the drawings, and are used only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the referenced devices or elements must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be construed as limiting the present invention.

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

In the description of the present invention, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art through specific situations.

As used herein, when describing the heart valve stent, "proximal" refers to the side of the delivery device or the direction of the user-manipulated end when the heart valve stent assumes an expanded state. Accordingly, "distal" refers to the side of the heart valve stent that is distal from the delivery device or away from the direction of the user-manipulated end when the heart valve stent assumes an expanded state. In the present application, when describing the heart valve stent, "proximal" refers to a side of the heart valve stent that is close to the apex of the heart when the heart valve stent assumes an expanded state. Accordingly, "distal" refers to the side of the heart valve stent that is distal to the apex of the heart when the heart valve stent is in an expanded state. Because the cardiac valve stent described herein is delivered by a catheter through the aorta, the distal and proximal ends refer to the same location, and the proximal and distal ends refer to the same location, but this does not preclude transapical implantation, but rather the cardiac valve stent is described herein as being delivered by a catheter through the aorta.

Example 1

The embodiment provides a pull-wire composite ring and a self-expanding heart valve stent comprising the same. The pull wire composite ring disclosed by the embodiment has a developing function, and can accurately position the self-expanding heart valve stent during operation. In addition, the pull-wire composite ring also comprises a through hole suitable for the pull wire to pass through, so that the positioning part of the self-expanding heart valve support can be operated conveniently.

Reference is first made to fig. 1 and 7, in which fig. 1 shows a perspective view of a self-inflating heart valve stent according to example 1 in an expanded state, and fig. 7 shows a development view of the heart valve stent according to the present example. As shown in fig. 1 and 7, the heart valve stent of the present embodiment may include a distal end of the heart valve stent close to the apex of the heart when the heart valve stent is in the expanded state and a proximal end of the heart valve stent far from the apex of the heart when the heart valve stent is in the expanded state. The proximal end of the heart valve stent may include connectors 14 and positioning members 12 and fasteners 13 disposed between adjacent connectors. The positioning member 12 may be used to position the self-expanding heart valve stent while the fastener 13 may be used to secure the prosthetic heart valve leaflets.

In the present embodiment, the positioning member 12 may include a first positioning arm 121, a second positioning arm 122, and a positioning member distal end 123 connecting the first positioning arm and the second positioning arm. The first positioning arm 121 is fixedly connected to a first connecting member, and the second positioning arm 122 is fixedly connected to a second connecting member, the first connecting member being adjacent to the second connecting member. Further, the fastener 13 includes a first fastening arc 131, a second fastening arc 132, and a fastener distal end 133 connecting the first fastening arc 131 and the second fastening arc 132. The first fastening arc 131 is fixedly connected to a first connecting member, and the second fastening arc 132 is fixedly connected to a second connecting member, the first connecting member being adjacent to the second connecting member. After the self-expanding heart valve stent is placed at the aortic valve position, the positioning member 12 will clamp the native valve leaflets with the fastening members 13, and the artificial heart valve leaflets inside the self-expanding heart valve stent will work in place of the native valve leaflets.

In one embodiment, referring to fig. 7, the first positioning arm 121 and the second positioning arm 122 are linear when the heart valve stent is in a compressed state. The first positioning arm 121 and the second positioning arm 122 are designed to be linear so as to facilitate compression, and when the first positioning arm and the second positioning arm are fully compressed, the occupied space is minimum, and the linear structure can ensure that the first positioning arm and the second positioning arm do not interfere with each other. In addition, the stent is formed by cutting a nickel-titanium tube, but the adopted material can be any material which can be implanted into a human body, the linear design is also beneficial to processing, the processing path is shortened, and the processing cost is reduced.

In one embodiment, the distal end of the spacer 12 has a parabolic configuration to reduce the contact stress of the spacer 12 with the sinus floor and prevent annular rupture.

In one embodiment, the fastener 13 has a width that is wider than the width of the spacer 12 to provide strong support.

In one embodiment, referring to FIGS. 14-16, in the expanded state of the self-inflating heart valve stent, the fastening arches of the fasteners 13 include fastening arch concave portions 136 and fastening arch convex portions 137. The fastening arc recessed portion 136 is an arc-shaped rod-like structure that is raised in a direction away from the self-expanding heart valve stent, and the arc-shaped structure is simultaneously directed in the direction of the proximal end of the self-expanding heart valve stent along the axis of the self-expanding heart valve stent, and the distal end of the fastening arc recessed portion 136 is fixedly connected to the fastening arc raised portion 137. The fastening arc protrusion portion 137 is an arc-shaped rod-like structure protruding toward the self-expanding heart valve stent while pointing in the direction of the distal end of the self-expanding heart valve stent along the axis of the self-expanding heart valve stent. The distal ends of the fastening arc protrusion portions 137 connect adjacent fastening arc protrusion portions 137 by the fastener distal ends 133. By such a design, the fastener distal end is made less open, preventing the prosthetic valve leaflet from opening too far into the native valve leaflet region. Secondly, the fastener 13 may be composed of two and/or three segments (for example, a linear segment is added between the concave portion 136 of the fastening arc and the convex portion 137 of the fastening arc), etc., and the fastener 13 composed of two segments obviously shows that the opening angle of the distal end of the fastener 13 relative to the convex portion 137 of the fastening arc is smaller, so that the change angle of the convex portion 137 of the fastening arc at the distal end of the fastener 13 is small in the process of compressing and expanding, although the nickel-titanium alloy has super elasticity, the too large compression expansion deformation still affects the performance of the nickel-titanium alloy, so that the deformation degree of the nickel-titanium alloy is reduced, the self-expansion performance of the nickel-titanium alloy can be better, and the self-expansion of the self-expanding heart valve stent is facilitated.

In one embodiment, the positioning member 12 has a second opening angle when the heart valve stent is in the expanded state, the second opening angle being 4 ° to 14 °. For example, the second opening angle may be 6 °, 8 °, 10 °, 12 °, etc. The positioning member 12 and the fastening member 13 form a certain opening angle, so that the positioning member 12 can catch the valve leaflets conveniently, and the operation difficulty is reduced. The positioning part 12 can be used for preventing the valve ventricle from displacing, so that the distal end of the artificial valve leaflet is aligned with the distal end of the native valve leaflet, the native valve can be restored to the maximum extent, the position of the original native valve can be kept, the native valve can be well replaced by the artificial valve, the influence on blood flow is reduced, the occurrence of thrombus is reduced, the positioning part 12 and the fastening part 13 can clamp the native valve to prevent the native valve from moving freely due to the arrangement of the second opening angle of 4-14 degrees, if the second opening angle is too large, the clamping force between the positioning part 12 and the fastening part 13 is weakened, the native valve leaflet cannot be clamped, and meanwhile, the native valve leaflet is tightly attached to the support, so that perivalvular leakage is reduced.

In one embodiment, the distal end of the positioning member 12 is positioned closest to the distal end of the heart valve stent at a vertical distance of 4mm to 8mm, preferably 6mm, from the distal-most portion of the heart valve stent (i.e., the capture end 16 described below).

In one embodiment, the distal end of the station end 16 is flared proximally relative to the station end 16, and the distal end of the station end 16 is flared proximally at an angle of 6 ° to 14 ° relative to the station end 16. The reason why the flaring is needed is to prevent the self-expanding heart valve stent from displacing towards the aorta and to perform anchoring function. At the same time, the reason why the excessive angle cannot be generated is to prevent the his bundle from being touched, thereby affecting the normal beating of the heart and endangering life.

In one embodiment, referring to fig. 1, the distal end of the heart valve stent further comprises a retaining end 16 and a reinforcing mesh 15, and a hollow 17 is present between the retaining end 16 and the reinforcing mesh 15. In this embodiment, the number of the diamond-shaped squares of the clamping end 16 is 18, which effectively ensures compressibility of the heart valve stent, and also ensures self-expansion property of the clamping end 16, and the rod widths of the diamond-shaped squares are gradually changed (thin in the middle and wide in two ends) to optimize fatigue resistance of the stent, and simultaneously enhance rebound effect of the clamping end 16, thereby facilitating self-expansion of the stent. In addition, because the heart valve support only comprises 18 diamond-shaped grids, only one reinforcing net 15 is needed to connect the clamping end 16 between the adjacent fastening arcs of the heart valve support, a large number of hollowed-out parts can be formed, the weight of the heart valve support is effectively reduced, the heart valve support is convenient to compress, and the rod width of the diamond-shaped grids is gradually changed (the middle part is thin and the two ends are wide) so as to optimize the fatigue resistance of the support. In addition, the presence of the reinforcing mesh 15 may both increase the central structural strength of the stent and isolate the native valve leaflets to prevent invasion of the artificial valve leaflets.

Next, further technical features of the reinforcing mesh 15 will be described in more detail with reference to fig. 7 and 8.

In another embodiment, referring to fig. 7 and 8, a reinforcing mesh 15 is disposed between the capture end 16 and the fasteners 13, a distal end of the reinforcing mesh 15 is secured to the capture end 16, and a proximal end of the reinforcing mesh 15 is fixedly attached between different fastening arcs of adjacent fasteners 13. In a preferred embodiment, the reinforcing mesh 15 comprises a plurality of interconnected reinforcing mesh structural units 151, the reinforcing mesh structural units 151 on one side of the proximal end of the reinforcing mesh 15 being fixedly connected to the second fastening arcs of the first fastening members, and the reinforcing mesh structural units 151 on the other side of the proximal end of the reinforcing mesh 15 being fixedly connected to the first fastening arcs of the second fastening members. In other words, the proximal ends of the reinforcing mesh 15 are respectively connected to different fastening arcs of different fasteners, thereby achieving a fixed connection. In one embodiment, the retaining end structural unit 151 is a diamond structure, the reinforcing mesh structural unit 151 at the distal end of the reinforcing mesh 15 and a retaining end structural unit 161 at the retaining end 16 share a vertex, and the reinforcing mesh structural unit 151 of the reinforcing mesh 15 and the fastening arc of the fastening member 13 share one or two sides. In one embodiment, the width of the rods 152 forming the reinforcing mesh structural unit 151 is smaller at the center and larger at the two ends, similar to the rods forming the retaining end structural unit 161.

In a preferred embodiment, the reinforcing mesh 15 comprises three layers connected to each other in sequence along the axial direction from the proximal end of the heart valve stent to the distal end of the heart valve stent, wherein the first layer comprises one reinforcing mesh structure unit 151, the second layer comprises two reinforcing mesh structure units 151, and the third layer comprises one reinforcing mesh structure unit 151. The reinforcing mesh structure unit 151 of the first layer shares one side with the second fastening arc of the fastener on its left, and shares one side with the first fastening arc of the fastener on its right. The reinforcing mesh structure unit 151 on the left side of the second layer shares one edge with the second fastening arc of the fastener 13 on the left side thereof, and the reinforcing mesh structure unit 151 on the right side of the second layer shares one edge with the first fastening arc of the fastener 13 on the right side thereof. The reinforcing mesh structure units 151 of the third layer share a vertex with the clamping end structure units. In this embodiment, the reinforcing mesh structure unit connecting region 154 of the second layer of the reinforcing mesh extends along the circumferential direction and the longitudinal direction of the self-expanding heart valve stent by a predetermined length, the reinforcing mesh structure unit connecting region 154 comprises a bending structure 153 which is concave towards the circumferential direction of the self-expanding heart valve stent, the bending structure 153 of the reinforcing mesh structure unit connecting region 154 can prevent the rod 152 from breaking during the compression and self-expansion processes of the clamping end 16 of the self-expanding heart valve stent, and the bending structure 153 can ensure that when the covering membrane is sutured by the self-expanding heart valve stent, the suture can be fixed at the bending structure 153, and the suture can be prevented from sliding on the clamping end structure unit to influence the fixation of the covering membrane.

Next, with reference to fig. 7 and 9, further technical features of the card terminal 16 will be described in more detail.

In one embodiment, and referring first to FIG. 9, the distal end of the self-expanding heart valve stent may comprise a retaining end 16, the retaining end 16 comprising a plurality of retaining end structural units 161 connected to one another, the rods 162 comprising the retaining end structural units 161 having a smaller width at the center and larger widths at the two ends. In the embodiment shown in fig. 9, the rods 162 of the locking end structure unit 161 may be symmetrical, have a minimum width in the middle, and then become larger smoothly toward both ends without abrupt stepwise changes. The edges of the bar 162 are smooth.

In one embodiment, the retaining end structure units 161 are diamond-shaped squares, and the retaining end 16 may include 18 retaining end structure units 161 arranged in a layer and connected to each other. Adjacent card end structural units 161 may be connected to each other by sharing a vertex. The adjacent end-of-site structural unit connection regions 164 extend a predetermined length circumferentially and longitudinally of the self-expanding heart valve stent, respectively.

Next, the structure of the connecting member 14 of the present embodiment will be described in more detail. Returning to fig. 1, the connection member 14 may include a connection block 141, a connection web 142, and a connection frame 143. One end of the connecting block 141 forms the proximal end of the heart valve stent, the other end is connected with the connecting frame 143 through the connecting web 142, and the connecting block 141 is used for being connected with a conveyor for conveying the heart valve stent.

Referring to fig. 7, the connecting frame 143 may sequentially include a positioning member connecting portion and a fastener connecting portion in a direction from a proximal end of the heart valve stent to a distal end of the heart valve stent.

In one embodiment, the width of the connection web 142 is less than the width of the connection block 141. In another embodiment, the attachment frame includes a hollow elongated suture hole 144. One end of the elongated suture hole 144 may be provided at the positioner connecting portion and the other end at the fastener connecting portion. The elongated suture hole 144 enables the proximal edge of the artificial leaflet to be directly passed through the suture hole for suturing without adding a suture spacer, and the edge of the artificial leaflet is sutured with the fastening arc. Compared with the traditional mode of using the gasket and the heart valve support to extrude and fix the valve leaflet, the suturing mode firstly reduces the external attached parts of the heart valve support, does not have the gasket, is beneficial to further compressing the heart valve support, and not only influences the support compression if the gasket exists, but also damages the artificial valve leaflet even under the condition that the support compression support is small.

Next, technical features of the pull wire composite ring 124 of the present embodiment will be described in detail with reference to fig. 1 to 6.

In another embodiment, the positioning member 12 may include a pull wire composite ring 124, wherein the pull wire composite ring 124 is fixedly connected to the positioning member 12 and is located on a side of the positioning member 12 facing the proximal end of the heart valve stent. In this embodiment, the pull wire composite ring 124 includes a connecting plate 1243 for fixed connection with a heart valve stent and a through hole 1242 adapted for a pull wire to pass through, and the pull wire composite ring 124 is configured to be identifiable under X-rays.

The distal end of the traditional positioning piece is provided with a marker (the marker is radiopaque), and although the marker is convenient to position and implant the stent to a certain extent, the marker is at risk of falling off. If the "marker" falls off and then flows with the blood into other organs, this will seriously affect the safety of the user. The pull-wire composite ring 124 of the embodiment eliminates a 'marker' mounting hole, and the pull-wire composite ring 124 is provided with a developing function, so that the safety of a user is improved.

As an example, an opaque layer of X-ray marker may be disposed on the surface of the web 1243 of the composite wire ring 124 or a high-density metal coating may be added on the surface of the web 1243, so that the composite wire ring 124 can be more visible under X-rays.

As another example, as shown in fig. 2-5, the external profile of the web 1243 may be provided in one or more of a gourd shape, a triangular shape, a circular shape, a diamond shape, or a cat's claw shape. The pull-wire composite ring 124 has a specific shape, so that an operator can quickly identify the pull-wire composite ring 124 to replace the mark 'marker'

In one embodiment, the connecting plate 1243 includes a fixed end and a free end, the fixed end of the connecting plate 1243 is fixedly connected with the heart valve stent, and the free end of the connecting plate 1243 is inclined inward along the axis of the heart valve stent.

In one embodiment, a through hole 1242 may be provided at a free end of the connection plate 1243. The pull wire can pass through the through hole 1242, so that the operation of the positioning part 12 is improved, the opening and closing control and positioning of the positioning part 12 can be realized, and the positioning part 12 can be favorable for reducing the difficulty of the operation through the opening angle. Because the through hole 1242 is convenient for threading the stay wire, in the implantation process, the opening angle of the positioning part 12 is controlled by the stay wire, so that the valve leaflet is convenient to capture, and the operation difficulty is reduced. In a preferred embodiment, the composite pull wire loop 124 is disposed inboard of the distal end 123 of the positioning element and is angled inwardly relative to the stent axis. In other words, the connecting plate 1243 of the composite pull wire loop 124 is fixedly connected to the distal end 123 of the positioning member 12, and may even be integrally formed. Because the pull-wire composite ring 124 is inclined inward relative to the axis of the self-expanding heart valve stent, the proximal end of the pull-wire composite ring can be prevented from colliding with the wall of the aorta during the shaking process of the stent, so that the aorta is damaged, and the aortic dissection of a user can be seriously caused, so that the life of the user is threatened.

Example 2

Example 2 differs from example 1 in that the proximal end of the self-inflating heart valve stent further comprises a support 11.

Referring to fig. 10 and 11, the proximal end of the self-expanding heart valve stent of the present embodiment further includes a support member 11, and the support member 11 is disposed between the adjacent connecting members 14. The support 11 may include a first support arm 111, a second support arm 112, and a support distal end 113 connecting the first support arm 111 and the second support arm 112, the first support arm 111 being fixedly connected to a first connector, the second support arm 112 being fixedly connected to a second connector, the first connector being adjacent to the second connector.

In this embodiment, the positioning member 12 is closer to the distal end of the self-expanding heart valve stent than the support member 11, and the fastening member 13 is closer to the distal end of the self-expanding heart valve stent than the positioning member 12. The distal ends of the support 11 and the positioning member 12 are rods projecting toward the distal end of the self-expanding heart valve stent. In this embodiment, the support 11 may be provided on one side of the native heart valve leaflets and the positioning member 12 on the other side of the native heart valve leaflets for clamping the native leaflets. The support 11 can clamp the native heart valve leaflets together with the positioning member 12, avoiding intrusion of the prosthetic heart valve leaflets.

Unlike embodiment 1, the connection frame 143 of the present embodiment further includes a support connection part that is closer to the connection block 141 than the positioning member connection part. In one embodiment, the support member connecting portions may be symmetrical and connected to the first support arm of the first support member and the second support arm of the adjacent second support member. In a preferred embodiment, the upper edge of the support arm at the junction with the connecting frame 143 is a smooth arc with an angle of 100 ° to 160 °. Meanwhile, the lower edge of the connection between the support arm and the connection frame 143 is also a smooth arc, and the angle of the arc is an acute angle.

In one embodiment, the width of the connection web 142 is less than the width of the connection block 141 and less than the width of the connection portion of the supporter. In another embodiment, the connecting frame 143 includes a hollow elongated suture hole 144. One end of the elongated suture hole 144 may be provided at the support member attachment portion and the other end at the retainer member attachment portion or the fastener attachment portion. The elongated suture hole 144 can realize that the proximal edge of the artificial heart valve leaflet directly passes through the suture hole to be sutured without adding a suture gasket, and the edge of the artificial heart valve leaflet is sutured with a fastening arc.

Referring to fig. 13, in one embodiment, the retaining end structure units 161 are diamond-shaped squares, and the retaining end 16 may include a plurality of retaining end structure units 161 arranged in a layer and connected to each other. Adjacent card end structural units 161 may be connected to each other by sharing a vertex. Adjacent ones of the retaining end structural unit connecting regions 164 extend a predetermined length circumferentially and longitudinally of the self-expanding heart valve stent, respectively, and in the circumferential direction of the self-expanding heart valve stent, the adjacent retaining end structural unit connecting regions 164 include curved structures 163 that are concave toward them. Because the width of the two ends of the rod 162 is widest, the rod 162 is widest at the position close to the clamping end structure unit connecting area 164 and is most difficult to deform, so that a large stress is generated in the process of compression and expansion, the rod 162 is easily broken at the position close to the clamping end structure unit connecting area 164, and therefore, the bending stress of the rod 162 at the position close to the clamping end structure unit connecting area 164 is reduced by adding the bending structure 163, the compression and self-expansion process of the clamping end of the self-expanding heart valve stent can effectively prevent the rod 162 from being broken at the clamping end structure unit connecting area 164, and meanwhile, the bending structure 163 can enable the suture thread to be fixed at the bending structure 163 when the stent is used for suturing the membrane, and the suture thread can be prevented from sliding on the clamping end structure unit to influence the fixation of the membrane.

Referring to fig. 12, the pull wire composite ring 124 of the present embodiment includes a connecting plate 1243 for fixed connection with a heart valve stent and a through hole 1242 for passing a pull wire therethrough, and the pull wire composite ring 124 is configured to be identifiable under X-ray. The pull wire composite ring 124 of this embodiment may also have a configuration as shown in fig. 3-6.

The features of the positioning member 12, the fastening member 13, the reinforcing mesh 15, and other structures not specifically described in this embodiment are the same as those of embodiment 1, and refer to the description of embodiment 1.

It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.

Claims

1. A pull wire composite ring fixedly attached to a heart valve stent, wherein the pull wire composite ring comprises a connecting plate for fixed attachment to the heart valve stent and a through hole adapted for a pull wire to pass through, and is configured to be identifiable under X-rays.

2. The pull wire composite ring of claim 1, wherein the connecting plate comprises a fixed end and a free end, the fixed end of the connecting plate fixedly connects to the heart valve stent, and the free end of the connecting plate is inclined inward along an axis of the heart valve stent.

3. The guy composite ring of claim 2, wherein the through hole is provided at a free end of the web.

4. The puller composite ring according to any one of claims 1-3, wherein the surface of the web is provided with an X-ray opaque marker layer or a high density metal plating.

5. The wiredrawing composite ring according to any of claims 1-3, wherein the external profile of the web is configured in one or more of a gourd shape, a triangular shape, a circular shape, a diamond shape, or a cat-claw shape.

6. A self-expanding heart valve stent comprising the pull-wire composite ring of any one of claims 1-5.

7. The self-expanding heart valve stent of claim 6, comprising a distal end of the self-expanding heart valve stent that is proximal to an apex of the heart when the heart valve stent is in an expanded state and a proximal end of the self-expanding heart valve stent that is distal to the apex of the heart when the heart valve stent is in an expanded state, wherein the proximal end of the heart valve stent comprises connecting members and positioning members and fasteners disposed between adjacent connecting members, the fasteners for securing prosthetic heart valve leaflets;

the positioning part comprises a first positioning arm, a second positioning arm and a positioning part far end for connecting the first positioning arm and the second positioning arm, the first positioning arm is fixedly connected to a first connecting piece, the second positioning arm is fixedly connected to a second connecting piece, and the first connecting piece is adjacent to the second connecting piece;

wherein the fastener comprises 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, the second fastening arc is fixedly connected to a second connector, and the first connector is adjacent to the second connector;

wherein the pull wire composite ring is fixedly connected to the distal end of the positioning member.

8. The self-expanding heart valve stent of claim 7, wherein the connector comprises a connector block, a connector web, and a connector frame, one end of the connector block forming the proximal end of the anti-regurgitation heart valve stent and the other end being connected to the connector frame through the connector web, the connector frame comprising in sequence a positioning member connector and a fastener connector in a direction from the proximal end of the anti-regurgitation heart valve stent to the distal end of the anti-regurgitation heart valve stent.

9. The self-expanding heart valve stent of claim 8, wherein the connecting web has a width less than a width of the connecting block.

10. The self-expanding heart valve stent of claim 8, wherein the attachment frame comprises a hollow elongated suture hole.

11. The self-expanding heart valve stent of claim 7, further comprising:

support piece, support piece sets up between adjacent connecting piece, support piece includes first support arm, second support arm and connects first support arm with the support piece distal end of second support arm, first support arm fixed connection is to first connecting piece, second support arm fixed connection is to the second connecting piece, first connecting piece with the second connecting piece is adjacent.

12. The self-expanding heart valve stent of claim 11, wherein the connector comprises a connector block, a connector web, and a connector frame, one end of the connector block forming the proximal end of the anti-regurgitation heart valve stent and the other end being connected to the connector frame through the connector web, the connector frame comprising in sequence a support member connector, a positioning member connector, and a fastener connector in a direction from the proximal end of the anti-regurgitation heart valve stent to the distal end of the anti-regurgitation heart valve stent.

13. The self-expanding heart valve stent of any one of claims 7-12, wherein the first and second fastening arches of the fastener comprise, when the self-expanding heart valve stent is in an expanded state:

a fastening arc recessed portion that is an arc-shaped rod-like structure that is convex toward a direction away from the self-expanding heart valve stent and that is convex toward a proximal end of the self-expanding heart valve stent at the same time;

a fastening arc projection portion that is an arc-shaped rod-like structure that projects toward the self-expanding heart valve stent and that simultaneously projects toward a distal end of the self-expanding heart valve stent;

the proximal end of the fastening arc concave part is connected to the connecting piece, the distal end of the fastening arc concave part is fixedly connected with the fastening arc convex part, and the distal end of the fastening arc convex part is connected with the adjacent fastening arc convex part through the distal end of the fastening piece.