Disclosure of Invention
The application aims to provide a high-elasticity anti-reflux heart valve stent. It has been found that the anti-regurgitation heart valve stent does not require a significant native leaflet clamping force, but rather requires the insertion of the positioning element into the non-closing surface of the native leaflet, i.e. the interior of the aortic sinus, and that all conventional stents have been designed with significant support force in order to maintain the shape of the stent, i.e. the stent as a whole has a certain strength, i.e. the positioning element is relatively rigidly connected to the proximal end of the stent, such design presents a significant problem in that the positioning element will rigidly impact the aortic sinus bottom each time the stent is subjected to regurgitation pressure from the aortic blood flow, typically about 3600 tens of thousands of beats per year, and thus the continued rigidity of the positioning element impacts the aortic sinus bottom, causing immeasurable damage to the aortic sinus bottom, even the aortic sinus bottom being punctured. In particular, in the highly elastic anti-reflux heart valve stent described herein, the fastening portion and the reinforcement mesh inside the fastening portion in a conventional heart valve stent are replaced with a diamond-shaped mesh that is resilient, making the positioning member resilient relative to the proximal end of the stent.
In order to solve the technical problems, the application provides the following technical scheme.
In a first aspect, the present application provides a highly elastic anti-regurgitation heart valve stent comprising a highly elastic anti-regurgitation heart valve stent proximal end and a highly elastic anti-regurgitation heart valve stent distal end, characterized in that the highly elastic anti-regurgitation heart valve stent distal end comprises positioning members arranged between adjacent connecting members for positioning the highly elastic anti-regurgitation heart valve stent, the positioning members comprising a first positioning arm, a second positioning arm and a positioning member distal end connecting the first positioning arm and the second positioning arm and protruding towards the highly elastic anti-regurgitation heart valve stent proximal end;
the proximal end of the high-elasticity anti-reflux heart valve stent comprises a clamping end, wherein the clamping end comprises at least one layer of diamond grid units which are connected with each other;
The high-elasticity anti-reflux heart valve stent further comprises a reinforcing net, wherein the reinforcing net comprises at least one quadrilateral grid unit which is elliptical or rhombic when the high-elasticity anti-reflux heart valve stent stretches, one end of the reinforcing net is fixedly connected with a connecting piece of the high-elasticity anti-reflux heart valve stent, and the other end of the reinforcing net is fixedly connected with the distal end of the rhombic grid unit;
the reinforcing mesh, together with the positioning member, sandwiches the native leaflet.
In one embodiment of the first aspect, the reinforcing mesh includes a first quadrilateral mesh unit, where the first quadrilateral mesh unit is formed by connecting a first link, a second link, a third link, and a fourth link, a proximal end of the first link is fixedly connected to a distal end of the second link, and a proximal end of the fourth link is fixedly connected to a distal end of the third link;
The distal ends of the first connecting rod and the fourth connecting rod are fixedly connected to the connecting piece, and the proximal ends of the second connecting rod and the third connecting rod are fixedly connected to the distal ends of the diamond grid units.
In an embodiment of the first aspect, the reinforcing mesh includes a first quadrilateral mesh unit and a second quadrilateral mesh unit, where the first quadrilateral mesh unit is formed by connecting a first link, a second link, a third link and a fourth link, a proximal end of the first link is fixedly connected to a distal end of the second link, a proximal end of the fourth link is fixedly connected to a distal end of the third link, the second quadrilateral mesh unit is formed by connecting a fifth link, a sixth link, a seventh link and an eighth link, a proximal end of the fifth link is fixedly connected to a distal end of the sixth link, and a proximal end of the eighth link is fixedly connected to a distal end of the seventh link;
The distal ends of the first connecting rod and the fourth connecting rod are fixedly connected to the connecting piece, the proximal ends of the sixth connecting rod and the seventh connecting rod are fixedly connected to the distal ends of the diamond grid units, and the second connecting rod, the third connecting rod, the fifth connecting rod and the eighth connecting rod share a vertex.
In an embodiment of the first aspect, the reinforcing mesh further includes two third quadrilateral mesh units, the two third quadrilateral mesh units are symmetrically disposed on two sides of the second quadrilateral mesh unit, one side, close to the second quadrilateral mesh unit, of the third quadrilateral mesh unit shares a vertex with the second quadrilateral mesh unit, a proximal end of the third quadrilateral mesh unit is fixedly connected to a distal end of the rhombic mesh unit, and the distal end of the third quadrilateral mesh unit is a free end.
In an embodiment of the first aspect, when the number of quadrilateral mesh units is two, the number of quadrilateral mesh units increases along the distal end of the high-elasticity anti-regurgitation heart valve stent towards the proximal end of the high-elasticity anti-regurgitation heart valve stent.
In one embodiment of the first aspect, the reinforcing mesh is provided with a plurality of layers of quadrilateral mesh units, and at least one layer of quadrilateral mesh units is 1.
In one embodiment of the first aspect, the stiffening web has at least three layers of quadrangular mesh units, the number of quadrangular mesh units per layer from the distal end to the proximal end of the stiffening web not being all increasing but being partly kept equal.
In one embodiment of the first aspect, the quadrilateral mesh unit is formed of a reinforcing mesh link that is thin at its middle and wide at its two ends. The diamond grid unit is composed of a clamping end connecting rod, and the middle of the clamping end connecting rod is thin and two ends of the clamping end connecting rod are wide.
In one embodiment of the first aspect, the first positioning arm and the second positioning arm are linear or curved.
In one embodiment of the first aspect, the positioning member has an opening angle of 2 ° -14 ° when the high elastic anti-reflux heart valve stent is stretched.
In one embodiment of the first aspect, the positioner distal end presents a parabolic shape.
In one embodiment of the first aspect, a vertical distance from the distal end of the positioning member to the distal end of the detent end is 2mm to 8mm.
In one embodiment of the first aspect, the distal end of the detent end is flared relative to the proximal end of the detent end, and the distal end of the detent end is flared at an angle of 6 ° to 14 ° relative to the proximal end of the detent end.
In one embodiment of the first aspect, the connecting piece includes a connecting block, a connecting web and a connecting frame, one end of the connecting block forms the proximal end of the anti-backflow heart valve stent, the other end is connected with the connecting frame through the connecting web, the distal end of the connecting frame is fixedly connected with the distal ends of the first positioning arm and the second positioning arm, and the proximal end of the connecting frame is fixedly connected with the distal end of the quadrangular mesh unit.
In one embodiment of the first aspect, the attachment frame includes an elongated suture hole adapted for passage of a prosthetic leaflet therethrough, one end of the elongated suture hole being proximal to the distal end of the attachment frame and the other end being proximal to the proximal end of the attachment frame.
In one embodiment of the first aspect, the distal end of the high-elasticity anti-regurgitation heart valve stent further comprises a support member disposed between adjacent connectors, the support member being closer to the distal end of the high-elasticity anti-regurgitation heart valve stent than the positioning member and for securing native leaflets;
The support includes a first support arm, a second support arm, and a support distal end connecting the first support arm and the second support arm and protruding toward a proximal end of the high elasticity anti-reflux heart valve stent.
In one embodiment of the first aspect, the connecting piece 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, the other end is connected with the connecting frame through the connecting web, the distal end of the connecting frame is fixedly connected with the distal ends of the first supporting arm and the second supporting arm, and the proximal end of the connecting frame is fixedly connected with the distal ends of the first positioning arm, the second positioning arm and the quadrangular lattice unit.
Compared with the prior art, the invention has the following positive effects:
1. The high-elasticity anti-reflux heart valve stent positioning piece is connected with the clamping end through the elastic reinforcing net, when the valve is subjected to aortic blood reflux pressure, the reinforcing net deforms to a certain extent, the impact of the positioning piece on the aortic sinus bottom is buffered, the damage of the positioning piece on the aortic sinus bottom is reduced, and the valve is more friendly to users;
2. the high-elasticity anti-reflux heart valve stent is easier to position and operate due to the arrangement of the stay wire composite ring.
In addition, the highly elastic anti-reflux heart valve stent described herein has the following advantages. The locating piece and the bracket generate a certain opening angle, so that the locating piece is convenient to catch the valve leaflet, the operation difficulty is reduced, the natural opening angle of the locating piece in the unfolded state ranges from 2 degrees to 14 degrees, and in the embodiment with the supporting piece, the opening angle of the supporting piece is smaller than that of the locating piece. The bottom of the positioning piece is parabolic, so that the contact stress between the positioning piece and the sinus bottom is reduced, and the annulus is prevented from being broken. The vertical distance from the distal end of the positioning piece to the distal end of the clamping end is 2mm-8mm, and the preferable size is 6mm;
The far end of the clamping end is outwards expanded relative to the near end of the clamping end, the angle of the far end of the clamping end is 6-14 degrees relative to the near end of the clamping end, the outwards expansion is required to be generated, the reverse flow support is prevented from being displaced towards the aortic direction, the clamping end and the aortic valve ring play an anchoring role, and the overlarge angle cannot be generated because the clamping end extending into the heart is prevented from touching the his bundle, so that the normal beating of the heart is influenced, and the life is endangered;
The support piece is connected with the distal end of the connecting piece, and the positioning piece is connected with the proximal end of the connecting piece, so that the design is to prevent the distal end of the support piece and the distal end of the positioning piece from forming a scissor structure, thereby shearing the primary valve leaflet and causing secondary damage to the primary valve leaflet of a human body;
the connecting rods of the quadrangular grid units and the rhombic grid units still adopt a form of thin middle and wide two ends, so that the fatigue resistance of the high-elasticity anti-reflux heart valve stent is improved, the rebound performance of the high-elasticity anti-reflux heart valve stent is improved, and the high-elasticity anti-reflux heart valve stent is convenient to self-expand.
Detailed Description
Unless defined otherwise, technical or scientific terms used in the specification and claims should be given the ordinary meaning as understood by one of ordinary skill in the art to which the invention pertains.
In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention.
Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first", "a second", etc. may explicitly or implicitly include one or more such feature. In the description of the present invention, unless otherwise indicated, the meaning of "a plurality" is two or more.
In the description of the present invention, unless explicitly stated and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be, for example, connected, detachably connected, or integrally connected, mechanically connected, electrically connected, directly connected, indirectly connected through intermediaries, or in communication 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 in a specific case.
As used herein, when describing the heart valve stent, "proximal" refers to the side of the delivery device or the side in 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 to the delivery device or the direction of the end manipulated by the user when the heart valve stent is in an expanded state. In the present application, when describing the heart valve stent, "proximal" refers to the side of the heart valve stent that is closer 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 from the apex of the heart when the heart valve stent is in an expanded state. Since the heart valve stent described herein is catheter delivered through the aorta, the distal end is co-located with the proximal end and the proximal end is co-located with the distal end, but this does not preclude implantation by transapical means, as described herein by way of example only.
The technical solution of the present application will be clearly and completely described in the following with reference to the accompanying drawings and embodiments of the present application.
Example 1
The present embodiment provides a highly elastic anti-regurgitation heart valve stent, the reinforcement mesh 13 of which comprises a quadrangular mesh unit 131.
Referring to fig. 1, the high-elasticity anti-regurgitation heart valve stent of the present embodiment may comprise a high-elasticity anti-regurgitation heart valve stent proximal end and a high-elasticity anti-regurgitation heart valve stent distal end. The distal end of the highly elastic anti-reflux heart valve stent includes a positioning member 12 disposed between adjacent connecting members 14. The positioning member 12 may be used to position a highly elastic anti-reflux heart valve stent. Referring to fig. 2, the positioner 12 may include a first positioner arm 121, a second positioner arm 122, and a positioner distal end 123 connecting the first positioner arm 121 and the second positioner arm 122 and protruding toward the proximal end of the high-elasticity anti-reflux heart valve stent. In this embodiment, the proximal end of the highly elastic anti-reflux heart valve stent includes a detent end 16, the detent end 16 comprising a layer of interconnected 18 diamond-shaped mesh cells 161.
In this embodiment, the high-elasticity anti-regurgitation heart valve stent further comprises a reinforcing mesh 13, wherein the reinforcing mesh 13 comprises a quadrangular mesh unit 131 which is elliptical or rhombic when the high-elasticity anti-regurgitation heart valve stent is stretched, one end of the reinforcing mesh 13 is fixedly connected with a connecting piece 14 of the high-elasticity anti-regurgitation heart valve stent, the other end of the reinforcing mesh 13 is fixedly connected with the distal end of the rhombic mesh unit 161, and the quadrangular mesh unit 131 is elastic in the axial direction.
Next, more details and features of the positioning member 12 of the high-elasticity anti-reflux heart valve stent of the present embodiment will be described first.
In this embodiment, the positioning member 12 may be used to position a highly elastic anti-reflux heart valve stent. 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 121 and the second positioning arm 122. The retainer distal end 123 may be convex toward the proximal end of the high-elasticity anti-reflux heart valve stent. The first positioning arm 121 is fixedly connected to a first connector and the second positioning arm 122 is fixedly connected to a second connector, the first connector being adjacent to the second connector. After the high-elasticity anti-regurgitation heart valve stent is placed in the aortic valve position, the positioning member 12 and the reinforcing mesh 13 clamp the native valve leaflets, and the artificial heart valve leaflets inside the high-elasticity anti-regurgitation heart valve stent work instead of the native valve leaflets.
In one embodiment, referring to fig. 2, 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 in order to facilitate compression of the highly elastic anti-reflux heart valve stent. When the high-elasticity anti-reflux heart valve stent is fully compressed, the occupied space is minimum, and the linear structure can ensure that the high-elasticity anti-reflux heart valve stent and the high-elasticity anti-reflux heart valve stent cannot interfere when being compressed. In addition, the high-elasticity anti-reflux heart valve stent of the embodiment can be cut by a nickel-titanium tube, but the material adopted 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 positioning member 12 may be parabolic in configuration, reducing contact stress of the positioning member 12 with the sinus floor, preventing annulus rupture. In one embodiment, the positioning member 12 has a second opening angle of 2 ° -14 ° when the high elastic anti-reflux heart valve stent is in an expanded state. For example, the second opening angle may be 4 °,6 °, 8 °, 10 °, 12 °, etc. The positioning piece 12 can be used for preventing the valve from shifting towards the ventricle when the valve is subjected to the reflux pressure of aortic blood flow, and enabling the distal end of the artificial valve leaflet to be always aligned with the end of the native valve She Yuanxin, so that the function of the native valve is restored to the greatest extent, and meanwhile, the artificial valve can be kept at the position of the original native valve, so that the artificial valve can well replace the native valve, the influence on blood flow is reduced, the occurrence of thrombus is reduced, the positioning piece 12 and the reinforcing net 13 can be relatively clamped by setting the second opening angle to be 2-14 degrees, the free movement of the native valve is prevented, if the opening angle is not set, the positioning piece 12 can be used for setting the inside of the native valve She Yaru bracket, the artificial valve leaflet She Qinrao is caused, the work is influenced, and if the second opening angle is set to be too large, the clamping force between the positioning piece 12 and the reinforcing net 13 is weakened, so that the native valve cannot be contacted with the positioning piece 12 and the reinforcing net 13 at the same time, the native valve cannot be tightly attached to the bracket, and the risk of paravalvular leakage of the valve is increased.
In one embodiment, the distal end of the positioning member 12 is closest to the distal end of the heart valve stent and is spaced from the distal end of the heart valve stent furthest (i.e., the detent end 16 described below) by a vertical distance of 2mm to 8mm, with a preferred dimension of 6mm.
In this embodiment, the highly elastic anti-reflux heart valve stent may further comprise a pull wire composite ring 124. Specifically, the positioning member 12 may include a pull wire composite ring 124, the pull wire composite ring 124 being fixedly connected to the positioning member 12 and located on a side of the positioning member 12 facing the high elastic anti-reflux heart valve stent. The pull wire compound ring 124 may include a first through hole 1241 and a second through hole 1242, the first through hole 1241 being used for mounting a marker, the second through hole 1242 being adapted to penetrate a pull wire, and the second through hole 1242 being closer to the heart valve stent proximal end than the first through hole 1241. In one embodiment, the first via 1241 has a larger pore size than the second via 1242. The distal end of the positioning member 12 is provided with a pull wire composite ring 124 which combines the attachment of the pull wire to a marker (the marker is radiopaque) to a location which effectively reduces the space occupation of the product. By using one position, the opening and closing control and the positioning of the positioning piece 12 can be realized, so that the compression performance of a product is improved, the product is conveyed by using a catheter, and the opening angle of the positioning piece 12 can be controlled, and the difficulty of operation is reduced. The stay wire composite ring 124 structure is provided with two through holes, the large holes are used for placing marker points so as to facilitate accurate positioning of implantation, ensure that the positioning piece touches the sinus bottom, penetrate the stay wire by the small Kong Fangbian, control the opening angle of the positioning piece 12 through the stay wire in the implantation process, facilitate capturing the valve leaflet and reduce the operation difficulty. In a preferred embodiment, the pull wire composite ring 124 is disposed on the inside of the distal end of the positioning member 12 (the inside being the opening direction of the positioning member 12) and is inclined inwardly with respect to the stent axis to prevent the proximal end of the pull wire composite ring from hitting the aortic wall during stent shaking, thereby damaging the aorta, which may seriously lead to aortic dissection for the user and life threatening.
Next, further details and features of the reinforcing mesh 13 will be described.
In this embodiment, the reinforcement mesh 13 can be used to sandwich the native leaflet with the positioning member 12. In this embodiment, the reinforcing mesh 13 may include one quadrangular mesh unit 131, and in this embodiment, the reinforcing mesh 13 may include only one first quadrangular mesh unit 1131, where the first quadrangular mesh unit 131 is formed by connecting a first link 1301, a second link 1302, a third link 1303, and a fourth link 1304, where a proximal end of the first link 1301 is fixedly connected to a distal end of the second link 1302, and a proximal end of the fourth link 1304 is fixedly connected to a distal end of the third link 1303. In this embodiment, the distal ends of the first link 1301 and the fourth link 1304 are fixedly connected to the connecting element 14, the proximal ends of the second link 1302 and the third link 1303 are fixedly connected to the distal ends of the diamond grid units 161 of the clamping end 16, after the valve stent is implanted in the aortic valve, the valve stent will bear the reflux pressure of the aortic blood flow, at this time, the aortic reflux blood will impact the artificial valve leaflets, the distal ends of the artificial valve leaflets are mainly closed, and will not bear a large amount of force perpendicular to the stent axis, the bottom (proximal end) of the artificial valve leaflets is completely sealed to form a blocking surface, so that the bottom (proximal end) of the artificial valve leaflets will be subjected to a large force perpendicular to the stent axis, when the bottom (proximal end) of the artificial valve leaflets is impacted by the blood flow, the clamping end 16 will be driven to move in the direction of the heart chamber, the clamping end 16 will transmit the force to the positioning element 12 through the reinforcing mesh 13, the positioning element 12 will not move down by the clamping end 16, the reinforcing mesh 13 of the stent is composed of the shape unit 131, the first link 1301 and the second link 1302 and the first link 1302 and the second link are not stressed by the force, the elastic impact force of the elastic impact element 16 is greatly reduced, and the elastic impact force is transmitted to the side of the elastic impact element is greatly stressed to the side of the opposite the clamping end 16, and the elastic impact end is reduced by the bending impact end 16 is stressed at the opposite the first end 16, and the opposite the side end 16.
Herein, for convenience of description, the links constituting the quadrangular mesh unit 131 are collectively referred to as a reinforcing mesh link. The quadrangular mesh unit 131 may be constituted by a reinforcing mesh link, which is thin at the middle and wide at both ends. Such a structure can optimize the fatigue resistance of the high-elasticity anti-regurgitation heart valve stent and improve the rebound performance of the high-elasticity anti-regurgitation heart valve stent.
Next, more details and features of the detent end 16 will be described.
The proximal end of the highly elastic anti-reflux heart valve stent may include a clamping end 16, and the clamping end 16 may include at least one layer of interconnected diamond-shaped mesh cells 161. The width center of the positioning end link 162 constituting the positioning end structure unit 161 is small and large at both ends. As shown in fig. 1 and 2, the lever 162 of the click end structure unit 161 may be symmetrical with the smallest width in the middle thereof, and then smoothly gets larger toward both ends without abrupt stepwise changes. The edges of the bar 162 are smooth. In one embodiment, the clamping end structural units 161 are diamond-shaped squares, and the clamping end 16 may include 18 clamping end structural units 161 arranged in a layer and connected to each other. Adjacent detent end structure units 161 may be connected to each other by sharing one vertex. The clip end structural unit attachment zones 164 extend a predetermined length along the circumferential and longitudinal directions of the highly elastic anti-reflux heart valve stent, respectively.
The distal end of the clamping end 16 expands outwardly relative to the proximal end of the clamping end 16, and the angle of the distal end of the clamping end 16 expanding outwardly relative to the proximal end of the clamping end 16 is 6-14 degrees, which is required to produce the cause of the expansion, prevent the reverse flow stent from displacing towards the aortic direction, cooperate with the aortic valve annulus to play an anchoring role, and cannot produce the cause of the excessive angle because the clamping end extending into the heart is prevented from touching the his bundle, thereby affecting the normal beating of the heart and endangering life.
Next, more details and technical features of the connector 14 will be described.
Returning to fig. 1, the connector 14 may include a connector block 141, a connector web 142, and a connector 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 connecting with a conveyor for conveying the heart valve stent. The distal ends of the connection frame 143 are fixedly connected with the distal ends of the first positioning arm 121 and the second positioning arm 122, and the proximal end of the connection frame 143 is fixedly connected with the distal ends of the quadrangular mesh units 131 of the reinforcing mesh 13. This prevents the positioning member 12 and the reinforcing mesh 13 from secondarily injuring the native valve leaflet by shearing force.
In one embodiment, the width of the connecting web 142 is less than the width of the connecting block 141. In another embodiment, the connecting frame 143 includes a hollow elongated suture hole 144. One end of the elongated suture hole 144 may be near the distal end of the connecting frame 143 and the other end near the proximal end of the connecting frame 143. The strip-shaped suture hole 144 can realize that the proximal edge of the artificial valve leaflet directly passes through the suture hole to be sutured without adding a suture pad, the edge of the artificial valve leaflet is sutured and connected with a covering film in the bracket, the covering film is arranged in the design bracket, namely, the clamping end 16 and the inner surface of the reinforcing net 13, namely, the surface facing the axis of the bracket, the artificial valve leaflet is sutured and connected with the covering film in a mode of relatively suturing the artificial valve leaflet to the bracket, the covering film is wide in connection area, the artificial valve leaflet is sutured by flexible design, the covering film can be made of high polymer materials such as PET (polyethylene terephthalate) or PTFE (polytetrafluoroethylene) or animal pericardial biological tissues, the covering film is covered on the inner surface of the design bracket to prevent blood leakage and achieve the sealing effect, and the artificial valve leaflet can be made of materials containing one or more synthetic materials, engineering biological tissues, biological valve leaflet tissues, pericardial tissues, cross-linked pericardial tissues, aortic root tissues, tissues subjected to chemical or biological processing/treatment tissues or a combination of the artificial valve leaflet tissues, and the pericardial tissues can be selected from but not limited by pigs, sheep, horses, human tissues or a combination of the groups of the materials. Compared with the traditional mode of using a gasket and a heart valve bracket to squeeze and fix the valve leaflets, the sewing mode firstly reduces externally-attached parts of the heart valve bracket, and is beneficial to further compression of the heart valve bracket without the gasket, if the gasket is arranged, the compression of the bracket is not only affected, but also the artificial valve leaflets can be damaged sometimes under the condition of small compression size of the bracket.
Example 2
The present embodiment provides a highly elastic anti-regurgitation heart valve stent comprising a support member 11, and the reinforcement mesh 13 thereof comprises a quadrangular mesh unit 161.
Referring to fig. 3 and 4, the high elastic anti-regurgitation heart valve stent of the present embodiment includes a support member 11, a positioning member 12, a reinforcing mesh 13, a connecting member 14 and a positioning end 16. The distal end of the high-elasticity anti-regurgitation heart valve stent according to the present embodiment further comprises a supporting member 11 disposed between the adjacent connecting members 14, wherein the supporting member 11 is closer to the distal end of the high-elasticity anti-regurgitation heart valve stent than the positioning member 12, and is used for fixing the native valve leaflet. The support 11 may comprise 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 and protruding towards the proximal end of the highly elastic anti-reflux heart valve stent. 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, the first connector being adjacent to the second connector.
In this embodiment, the positioning member 12 is closer to the distal end of the highly elastic anti-reflux heart valve stent than the support member 11. The support distal end 113 and the positioner distal end 123 are rods protruding towards the heart valve stent distal end. The support 11 is provided on one side of the native heart valve leaflet and the positioning member 12 is provided on the other side of the native heart valve leaflet.
Compared with the traditional heart valve stent, the heart valve stent further comprises the supporting piece 11, so that the native valve leaflet can be clamped between the supporting piece 11 and the positioning piece 12, the supporting piece 11 prevents the native valve She Qinrao from being manually operated, and the native valve leaflet is clamped by the supporting piece 11 and the positioning piece 12, so that the clamping is relatively firmer, and meanwhile, the supporting piece 11 is beneficial to the self-expansion of the high-elasticity anti-reflux heart valve stent, so that the radial force during self-expansion is increased.
In one embodiment, referring to fig. 4, the first support arm 111 and the second support arm 112 are linear when the high elastic anti-reflux heart valve stent is in a compressed state. The first positioning arm 111 and the second positioning arm 112 are designed to be linear, so as to facilitate compression of the high-elasticity anti-regurgitation heart valve stent, and when the high-elasticity anti-regurgitation heart valve stent is fully compressed, the space occupied by the high-elasticity anti-regurgitation heart valve stent is minimum, that is, the adjacent first support arm 111 and second support arm 112 can be fully closed during compression. The purpose of the first support arm 111 and the second support arm 112 being linear is to be sufficiently close together to not interfere when compressed. In addition, the high-elasticity anti-reflux heart valve stent can be cut by adopting a nickel-titanium tube, and the linear design is also beneficial to processing, so that the processing path is shortened, and the processing cost is reduced.
In this embodiment, the connection member 14 may include a connection block 141, a connection web 142, and a connection frame 143, one end of the connection block 141 forms the proximal end of the anti-backflow heart valve stent, the other end is connected to the connection frame 143 through the connection web 142, the distal end of the connection frame 143 is fixedly connected to the distal ends of the first support arm 111 and the second support arm 112, and the proximal end of the connection frame 143 is fixedly connected to the first positioning arm 121, the second positioning arm 122, and the distal ends of the quadrangular mesh units 131 of the reinforcement mesh 13.
In this embodiment, similar to embodiment 1, the positioning member 12 is provided with a pull-string compound ring 124, and the connecting frame 143 includes a hollow elongated suture hole 144. The features of the positioning member 12, the reinforcing mesh 13, the clamping end 16, the pull wire composite ring 124, the connecting block 141, the connecting web 142 and the elongated suture hole 144, which are not described in detail in this embodiment, are the same as those of embodiment 1, and will not be described again here.
Example 3
The present embodiment provides a highly elastic anti-regurgitation heart valve stent, the reinforcement mesh 13 of which comprises a first quadrangular mesh unit 131 and a second quadrangular mesh unit 132.
Referring to fig. 5 and 6, the reinforcement mesh 13 of the high elastic anti-regurgitation heart valve stent of the present embodiment includes a first quadrangular mesh unit 131 and a second quadrangular mesh unit 132, and the first quadrangular mesh unit 131 is formed by connecting a first link 1301, a second link 1302, a third link 1303 and a fourth link 1304. The proximal end of the first link 1301 is fixedly connected to the distal end of the second link 1302, the proximal end of the fourth link 1304 is fixedly connected to the distal end of the third link 1303, and the second quadrilateral mesh unit 132 is formed by connecting a fifth link 1305, a sixth link 1306, a seventh link 1307, and an eighth link 1308. The proximal end of the fifth link 1305 is fixedly connected to the distal end of the sixth link 1306, and the proximal end of the eighth link 1308 is fixedly connected to the distal end of the seventh link 1307. In this embodiment, the distal ends of the first link 1301 and the fourth link 1304 are fixedly connected to the connecting member 14, the proximal ends of the sixth link 1306 and the seventh link 1307 are fixedly connected to the distal ends of the diamond grid cells 161, and the second link 1302, the third link 1303, the fifth link 1305, and the eighth link 1308 share a vertex.
The reinforcing mesh 13 may include one, two or three layers of quadrangular mesh units 131, and preferably may include two layers of quadrangular mesh units 131. The positioning member 12 is required to have a certain length, that is, to ensure that the distal end 123 of the positioning member is sufficiently inserted into the sinus floor, so that the high elastic anti-regurgitation heart valve stent must have a certain axial length. In the case where the reinforcing mesh 13 has only one quadrangular mesh unit 131, insufficient torsion resistance is easily caused at the proximal end of the high-elasticity anti-regurgitation heart valve stent and at the distal end of the high-elasticity anti-regurgitation heart valve stent, so that the high-elasticity anti-regurgitation heart valve stent is easily twisted, and the high-elasticity anti-regurgitation heart valve stent is entirely bent. In addition, in the embodiment where the reinforcing mesh 13 includes only one quadrangular mesh unit 131, the reinforcing mesh 13 is excessively long in the link, and is greatly deformed in the heat setting and compression excessively long, so that the deformation track thereof is not easily controlled.
By adopting the two-layer quadrilateral mesh unit 131 structure, the distance between the proximal end and the distal end of the reinforcing mesh connecting rod of each quadrilateral mesh unit 131 can be effectively reduced, and the deformation controllability of the quadrilateral mesh units 131 is improved.
The features of the positioning member 12, the connecting member 14, the clamping end 16 and the pull wire compound ring 124, which are not described in detail in this embodiment, are the same as those of embodiment 1, and will not be described again here.
Example 4
The present embodiment provides a highly elastic anti-regurgitation heart valve stent, the reinforcement mesh 13 of which comprises a first quadrangular mesh unit 131 and a second quadrangular mesh unit 132. In addition, the highly elastic anti-regurgitation heart valve stent of the present embodiment further comprises a support 11.
Referring to fig. 7 and 8, the high-elasticity anti-regurgitation heart valve stent of the present embodiment is compared with the high-elasticity anti-regurgitation heart valve stent of embodiment 2 in that the reinforcement mesh 13 of the high-elasticity anti-regurgitation heart valve stent of the present embodiment includes a first quadrangular mesh unit 131 and a second quadrangular mesh unit 132, the first quadrangular mesh unit 131 being formed by connecting a first link 1301, a second link 1302, a third link 1303 and a fourth link 1304. The proximal end of the first link 1301 is fixedly connected to the distal end of the second link 1302, the proximal end of the fourth link 1304 is fixedly connected to the distal end of the third link 1303, and the second quadrilateral mesh unit 132 is formed by connecting a fifth link 1305, a sixth link 1306, a seventh link 1307, and an eighth link 1308. The proximal end of the fifth link 1305 is fixedly connected to the distal end of the sixth link 1306, and the proximal end of the eighth link 1308 is fixedly connected to the distal end of the seventh link 1307. In this embodiment, the distal ends of the first link 1301 and the fourth link 1304 are fixedly connected to the connecting member 14, the proximal ends of the sixth link 1306 and the seventh link 1307 are fixedly connected to the distal ends of the diamond grid cells 161, and the second link 1302, the third link 1303, the fifth link 1305, and the eighth link 1308 share a vertex.
The features of the supporting member 11, the positioning member 12, the connecting member 14, the clamping end 16 and the pull wire compound ring 124, which are not described in detail in this embodiment, are the same as those of embodiment 2, and will not be described again.
Example 5
The present embodiment provides a high-elasticity anti-regurgitation heart valve stent, the reinforcement mesh 13 of which comprises a first quadrangular mesh unit 131, a second quadrangular mesh unit 132, and two third quadrangular mesh units 133.
Referring to fig. 9 to 13, in comparison with embodiment 3, the reinforcing mesh 13 of the present embodiment further includes two third quadrangular mesh units 133 symmetrically disposed on both sides of the second quadrangular mesh unit 132, the proximal ends of the third quadrangular mesh units 133 being fixedly connected to the distal ends of the diamond-shaped mesh units 161 of the click terminals 16, but the distal ends of the third quadrangular mesh units 133 being free ends.
Specifically, the third quadrangular mesh unit 133 may be formed by connecting a ninth link 1309, a tenth link 1310, an eleventh link 1311, and a twelfth link 1312. The proximal end of the ninth link 1309 is fixedly connected to the distal end of the tenth link 1310, and the proximal end of the twelfth link 1312 is fixedly connected to the distal end of the eleventh link 1311. For the third square grid cell 133 disposed on the left side of the second square grid cell 132, the eleventh link 1311 and the twelfth link 1312 of the third square grid cell 133 share one vertex with the fifth link 1305 and the sixth link 1306 of the second square grid cell 132. For the third square grid cell 133 disposed on the right side of the second square grid cell 132, the ninth link 1309 and the tenth link 1310 of the third square grid cell 133 share one vertex with the seventh link 1307 and the eighth link 1308 of the second square grid cell 132. At the same time, the distal end of the ninth link 1309 is fixedly connected to the distal end of the twelfth link 1312 and not to other components of the highly elastic anti-reflux heart valve stent, forming the free end of the third quadrilateral mesh unit 133. The proximal end of the tenth link 1310 is fixedly connected to the proximal end of the eleventh link 1311 and shares a vertex with the distal end of the diamond shaped grid element 161 of the detent end 16.
In this embodiment, the number of the two layers of quadrilateral mesh units 131 increases (preferably 2 are added to each layer) along the distal end of the high-elasticity anti-regurgitation heart valve stent towards the proximal end of the high-elasticity anti-regurgitation heart valve stent, and the proximal ends of the upper layers of quadrilateral mesh units 131 are connected with the distal ends of the lower layers of quadrilateral mesh units 131 instead of intersecting to form a network structure, and the outer outline of the reinforcing mesh 13 is integrally and approximately formed into a triangular-like reinforcing mesh 13, so that the stability between the proximal ends of the high-elasticity anti-regurgitation heart valve stent and the distal ends of the high-elasticity anti-regurgitation heart valve stent can be effectively increased. This embodiment is illustrated as the reinforcing mesh 13 having two layers of quadrangular mesh units, 1 and 3 quadrangular mesh units per layer from the distal end to the proximal end of the reinforcing mesh 13, and other embodiments may have 1 and 5 quadrangular mesh units, etc.
Further, when the reinforcing mesh 13 is provided with multiple layers of quadrilateral mesh units 131, at least one layer of quadrilateral mesh units 131 is 1, so that the reinforcing mesh 13 is guaranteed to have elasticity in the axial direction, and because the reinforcing mesh is provided with multiple layers of quadrilateral mesh units 131 in one layer, the axial elasticity of the reinforcing mesh is inevitably reduced, the damping effect of the reinforcing mesh 13 on the positioning piece 12 is affected, and therefore, the reinforcing mesh 13 needs to be guaranteed to have at least one layer of quadrilateral mesh units 131;
In some embodiments, the reinforcing mesh 13 has multiple layers (greater than 2 layers) of quadrilateral mesh units, and the number of quadrilateral mesh units 131 per layer from the distal end to the proximal end of the reinforcing mesh 13 may not be all increasing, but may remain partially equal, e.g., 1, 3, or 1, 5, respectively, quadrilateral mesh units 131 per layer from the distal end to the proximal end of the reinforcing mesh 13.
The features of the positioning member 12, the connecting member 14, the clamping end 16 and the pull wire compound ring 124, which are not described in detail in this embodiment, are the same as those of embodiment 1, and will not be described again here.
Example 6
The present embodiment provides a high-elasticity anti-regurgitation heart valve stent, the reinforcement mesh 13 of which comprises a first quadrangular mesh unit 131, a second quadrangular mesh unit 132, and two third quadrangular mesh units 133. In addition, the highly elastic anti-regurgitation heart valve stent of the present embodiment further comprises a support 11.
Referring to fig. 14 and 15, in comparison with embodiment 4, the reinforcing mesh 13 of the present embodiment further includes two third quadrangular mesh units 133 symmetrically disposed on both sides of the second quadrangular mesh unit 132, the proximal ends of the third quadrangular mesh units 133 being fixedly connected to the distal ends of the diamond-shaped mesh units 161 of the click terminals 16, but the distal ends of the third quadrangular mesh units 133 being free ends.
Specifically, the third quadrangular mesh unit 133 may be formed by connecting a ninth link 1309, a tenth link 1310, an eleventh link 1311, and a twelfth link 1312. The proximal end of the ninth link 1309 is fixedly connected to the distal end of the tenth link 1310, and the proximal end of the twelfth link 1312 is fixedly connected to the distal end of the eleventh link 1311. For the third square grid cell 133 disposed on the left side of the second square grid cell 132, the eleventh link 1311 and the twelfth link 1312 of the third square grid cell 133 share one vertex with the fifth link 1305 and the sixth link 1306 of the second square grid cell 132. For the third square grid cell 133 disposed on the right side of the second square grid cell 132, the ninth link 1309 and the tenth link 1310 of the third square grid cell 133 share one vertex with the seventh link 1307 and the eighth link 1308 of the second square grid cell 132. At the same time, the distal end of the ninth link 1309 is fixedly connected to the distal end of the twelfth link 1312 and not to other components of the highly elastic anti-reflux heart valve stent, forming the free end of the third quadrilateral mesh unit 133. The proximal end of the tenth link 1310 is fixedly connected to the proximal end of the eleventh link 1311 and shares a vertex with the distal end of the diamond shaped grid element 161 of the detent end 16.
In the present embodiment of the present invention, in the present embodiment,
In this embodiment, the number of the two layers of quadrilateral mesh units 131 increases (preferably 2 are added to each layer) along the distal end of the high-elasticity anti-regurgitation heart valve stent towards the proximal end of the high-elasticity anti-regurgitation heart valve stent, and the proximal ends of the upper layers of quadrilateral mesh units 131 are connected with the distal ends of the lower layers of quadrilateral mesh units 131 instead of intersecting to form a network structure, and the outer outline of the reinforcing mesh 13 is integrally and approximately formed into a triangular-like reinforcing mesh 13, so that the stability between the proximal ends of the high-elasticity anti-regurgitation heart valve stent and the distal ends of the high-elasticity anti-regurgitation heart valve stent can be effectively increased. This embodiment is illustrated as the reinforcing mesh 13 having two layers of quadrangular mesh units, 1 and 3 quadrangular mesh units per layer from the distal end to the proximal end of the reinforcing mesh 13, and other embodiments may have 1 and 5 quadrangular mesh units, etc.
Further, when the reinforcing mesh 13 is provided with multiple layers of quadrilateral mesh units 131, at least one layer of quadrilateral mesh units 131 is 1, so that the reinforcing mesh 13 is guaranteed to have elasticity in the axial direction, and the reinforcing mesh 13 is guaranteed to have at least one layer of quadrilateral mesh units 131 because the reinforcing mesh is provided with multiple layers of quadrilateral mesh units 131, which inevitably leads to the axial elasticity reduction of the reinforcing mesh and influences the damping effect of the reinforcing mesh 13 on the positioning piece 12.
In some embodiments, the reinforcing mesh 13 has multiple layers (greater than 2 layers) of quadrilateral mesh units, and the number of quadrilateral mesh units 131 per layer from the distal end to the proximal end of the reinforcing mesh 13 may not be all increasing, but may remain partially equal, e.g., 1, 3, or 1, 5, respectively, quadrilateral mesh units 131 per layer from the distal end to the proximal end of the reinforcing mesh 13.
The features of the supporting member 11, the positioning member 12, the connecting member 14, the clamping end 16 and the pull wire compound ring 124, which are not described in detail in this embodiment, are the same as those of embodiment 2, and will not be described again.
Example 7
This embodiment provides a highly elastic anti-regurgitation heart valve stent similar in structure to the highly elastic anti-regurgitation heart valve stent described in embodiment 5. The only difference is that the first positioning arm 121 and the second positioning arm 122 of the positioning member 12 are curved. Specifically, the first positioning arm 121 may include a first positioning arm protruding portion 125 protruding toward an adjacent connector, and the second positioning arm 122 may include a second positioning arm protruding portion 126 protruding toward an adjacent connector. The spacer 12 formed by bending cutting is capable of cutting a longer spacer 12 with the same length of nitinol tube than a conventional cut linear spacer 12. This effectively increases the axial length of the positioning member 12 in the extended state. In other words, for a length of the high elastic anti-regurgitation heart valve stent, the positioning member 12 employing curved cutting is relatively straightened when the high elastic anti-regurgitation heart valve stent is in a deployed state, which enables insertion into the deeper aortic sinus floor.
The embodiments are described above in order to facilitate the understanding and application of the present application by those of ordinary skill in the art. It will be apparent to those skilled in the art that various modifications can be made to these embodiments and that the general principles described herein may be applied to other embodiments without the use of inventive faculty. Therefore, the present application is not limited to the embodiments herein, and those skilled in the art, based on the present disclosure, may make improvements and modifications within the scope and spirit of the present application without departing from the scope and spirit of the present application.