A heart valve device

Abstract

The application discloses a heart valve device and relates to the technical field of artificial heart valves, which comprises an outer valve frame and a valve leaflet assembly connected to the inside of the outer valve frame, and the outer valve frame is a ring-shaped grid frame; the outer valve frame comprises an inflow side grid frame and an outflow side grid frame arranged in sequence from an inflow end to an outflow end, and the inflow side grid frame and the outflow side grid frame form an annular recess for clamping a native valve ring on the outer periphery of the outer valve frame; the outflow side grid frame comprises a plurality of groups of grid support units connected in sequence along the circumferential direction and enclosed into a ring, and the grid support unit comprises an outer convex grid support and an inner concave grid support, and the outer surface of the inner concave grid support is arranged in a concave manner relative to the outer surface of the outer convex grid support. In this way, the anterior leaflet of the original mitral valve can be attached to the inner concave grid support, the extrusion of the outer valve frame on the anterior leaflet is reduced, the anterior leaflet is prevented from being extruded to the left ventricular outflow tract by the outer valve frame, and the outflow area of the left ventricular outflow tract is prevented from being reduced to cause obstruction.

Description

Technical Field

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

[0002] With the continuous development of transcatheter artificial heart valve replacement technology, it has become the preferred treatment option for most patients. However, in transcatheter mitral valve replacement, if the size of the valve frame in the left ventricle is too large, it will mechanically compress and push the anterior leaflet of the mitral valve into the left ventricular outflow tract, leading to postoperative complications such as left ventricular outflow tract obstruction.

[0003] Therefore, there is a need to design a heart valve device that has minimal impact on the left ventricular outflow tract, so as to minimize trauma to patients while ensuring safety. Summary of the Invention

[0004] Therefore, the purpose of this invention is to provide a heart valve device to solve the problem that existing artificial heart valves compress the anterior leaflet of the mitral valve after implantation of an autologous valve, which can easily cause left ventricular outflow tract obstruction, and can also prevent postoperative complications such as paravalvular leakage.

[0005] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows: A heart valve device includes an external valve frame, which is an annular mesh frame; the external valve frame has an inflow end and an outflow end, and the external valve frame includes an inflow-side mesh frame and an outflow-side mesh frame arranged sequentially from the inflow end to the outflow end; The outflow side grid frame includes multiple sets of grid support units that are connected continuously along their circumference and form a ring. The grid support unit includes an outwardly convex grid support and an inwardly concave grid support. The outer surface of the inwardly concave grid support is recessed relative to the outer surface of the outwardly convex grid support.

[0006] Furthermore, the inflow-side mesh frame and the outflow-side mesh frame form annular recesses on the outer periphery of the outer valve frame for clamping the autologous valve annulus. Furthermore, the number of the concave mesh supports is one or more sets.

[0007] Furthermore, the number of concave mesh supports and the number of convex mesh supports can be the same or different.

[0008] Furthermore, when the number of concave mesh supports and the number of convex mesh supports are the same, each group of concave mesh supports occupies the same angle in the circumferential direction of the outflow side mesh frame, and each group of convex mesh supports occupies the same angle in the circumferential direction of the outflow side mesh frame; the concave mesh supports and the convex mesh supports may occupy the same or different angles in the circumferential direction of the outflow side mesh frame.

[0009] Furthermore, the outflow side grid frame includes three sets of convex grid supports and three sets of concave grid supports that are alternately connected along its circumferential direction.

[0010] Furthermore, one end of each of the multiple sets of grid support units is connected to the inflow-side grid frame, and the concave grid support and the adjacent convex grid support have a hollow area in the circumferential direction of the outflow-side grid frame; the other ends of the multiple sets of grid support units away from the inflow-side grid frame are connected as one unit by a circumferentially arranged circumferential connector.

[0011] Furthermore, the circumferential connector and the outer petal frame are an integral structure.

[0012] Furthermore, the circumferential connector and the outer petal frame are made of the same material.

[0013] Furthermore, the circumferential connector is a foldable and bendable elastic support rod. When the outer petal frame is in a radially contracted state, the circumferential connector is compressed, bent, and folded into the gap between the concave mesh support and the convex mesh support. When the outer petal frame is in a radially extended state, the circumferential connector unfolds under its own restoring force and is supported between two adjacent petal frame connecting pieces. This foldable and bendable circumferential connector does not require additional space when the outer petal frame is radially contracted, and can be supported between the outflow sides of two adjacent sets of mesh support units when the outer petal frame is radially extended, enhancing the radial stiffness of the outer petal frame. This makes the multiple sets of mesh support units form a ring shape after unfolding, improving the overall stability of the outer petal frame after unfolding.

[0014] Furthermore, the grid support unit includes multiple rows of support rods connected continuously from the inflow end to the outflow end. Each row of support rods includes one angled support rod or multiple angled support rods connected at the top. The number of angled support rods in different rows of support rods gradually decreases from the inflow end to the outflow end. When the outer petal frame is in a radially expanded state, two adjacent grid support units and the circumferential connectors connecting the two adjacent grid support units enclose a triangular-shaped petal frame hollow area.

[0015] Furthermore, the first row of barbs is provided at the apex of the first row of support rods closest to the inflow-side grid frame of the grid support unit. The first row of barbs is used to anchor the outer valve frame to the annulus of the native mitral valve.

[0016] Furthermore, the apex of the second row of support rods adjacent to the first row of support rods in the convex mesh support is provided with a second row of barbs, which are used to anchor the external valve frame to the posterior leaflet of the original mitral valve or the ventricular wall.

[0017] Furthermore, each of the multiple sets of grid support units is provided with a petal frame connecting piece at the other end away from the inflow side grid frame, and two adjacent petal frame connecting pieces are connected as one unit by a circumferentially arranged circumferential connector.

[0018] Furthermore, the valve frame connector is provided with a release hole, and the valve frame connector is connected to the delivery device for releasing the heart valve through the release hole.

[0019] Furthermore, the end of the inflow-side grid frame away from the outflow-side grid frame bends outward in the radial direction relative to the outer petal frame; the inflow-side grid frame includes multiple sets of grid groups that are connected and form a ring, and two adjacent sets of grid groups forming the same ring are connected by a vertex or a side, and the vertices of the multiple sets of grid groups near the outflow-side grid frame are connected to the vertices at the top of the inflow-side grid frame.

[0020] Furthermore, the grid assembly includes a first valve support rod arranged at an angle, an axial connector, and a second valve support rod arranged at an angle. The axial connector connects the apex of the first valve support rod and the apex of the second valve support rod. The first valve support rod and / or the second valve support rod are curved outwards. The inflow-side grid frame has a flange-shaped structure and is located at the position from the annulus of the native mitral valve to the atrial wall, conforming to the atrial wall to prevent the external valve support from falling into the ventricle and also providing an anchoring and sealing function.

[0021] Furthermore, at least one set of the concave mesh support is connected to a clamping member, which is an elastically bendable clamping member; when the outer valve support is in a radially contracted state, multiple clamping members are straightened outwards towards the outflow end along the central axis of the outer valve support; when the outer valve support is in a radially expanded state, multiple clamping members are bent outwards towards the outer side of the outer valve support, and one of the clamping members presses the anterior leaflet of the native mitral valve against the outer side of the concave mesh support and cooperates with the concave mesh support to clamp the anterior leaflet of the native mitral valve.

[0022] Furthermore, the clamping member includes a pair of curved support rods and a middle skirt, one end of the pair of curved support rods is connected to the concave grid support, and the other end of the pair of curved support rods is connected; the middle skirt is connected between the pair of curved support rods and covers the space enclosed by the pair of curved support rods.

[0023] Furthermore, the clamping member includes a pair of curved short rods, an arc-shaped round rod, and a middle skirt. One end of the pair of curved short rods is connected to the concave grid support, and both ends of the arc-shaped round rod are respectively connected to the other ends of the pair of curved short rods. The middle skirt is connected to the arc-shaped round rod and covers the space enclosed by the pair of curved short rods and the arc-shaped round rod.

[0024] Furthermore, the inflow end of the outer petal frame is connected to a skirt extending to the outside of the inflow mesh frame.

[0025] Furthermore, the heart valve device also includes an inner valve frame located inside the outer valve frame, with a leaflet assembly connected to the inner side of the inner valve frame. An inflow-side sealing skirt is sealingly connected between the inflow end of the inner valve frame and the inflow end of the outer valve frame, and the inflow-side sealing skirt forms a circumferential seal on the outer periphery of the leaflet assembly.

[0026] Furthermore, the inner side of the outer valve frame is connected to an inner skirt of the outer valve frame; the inner skirt of the outer valve frame covers the first row of support rods between the inner side of the inflow side grid frame and the inner side of the outflow side grid frame, and the second valve frame support rod of the inflow side grid frame is used to abut against the valve annulus of the native mitral valve.

[0027] Furthermore, the inner valve frame includes an inner valve frame mesh frame in the form of an annular grid, and an inner valve frame skirt connected to the inner valve frame mesh frame. The inflow-side sealing skirt is sealed between the inner side skirt of the outer valve frame and the inner valve frame skirt; the inflow side of the outer valve frame and the inner valve frame is sealed to form a circumferential seal on the outer periphery of the leaflet assembly.

[0028] Furthermore, the inner flap skirt is connected to the inner or outer side of the inner flap mesh frame.

[0029] Furthermore, the outflow end of the inner valve frame is provided with a plurality of circumferentially arranged valve feet, which are fixedly connected to the valve frame connecting piece of the outer valve frame by stitches.

[0030] The technical solution of this invention has the following advantages: 1. The heart valve device provided by the present invention, when delivered to the annulus of the native mitral valve, allows the outer valve frame, which is in the shape of an annular mesh frame, to expand radially outward. The inflow-side mesh frame of the outer valve frame is located on the atrial side, and the outflow-side mesh frame is located on the ventricular side. The outflow-side mesh frame is formed by connecting convex and concave mesh supports circumferentially to form a ring, with the outer surface of the concave mesh support being concave relative to the outer surface of the convex mesh support. The anterior leaflet of the native mitral valve can fit against the outer side of the concave mesh support. Compared with the prior art where the anterior leaflet of the native mitral valve abuts against the outer surface of the convex mesh support of the outer valve frame, this method reduces the compression of the anterior leaflet by the outer valve frame, avoids squeezing the anterior leaflet into the left ventricular outflow tract, thus reducing the area of ​​the left ventricular outflow tract and preventing left ventricular outflow tract obstruction.

[0031] 2. The heart valve device provided by this invention includes an outflow side mesh frame of the external valve frame comprising three sets of convex mesh supports and three sets of concave mesh supports that are alternately connected along their circumferential direction. The convex and concave mesh supports are arranged at 60° intervals, and the two sets of concave mesh supports are arranged at 120° intervals. The anterior leaflet can be attached to the outer surface of any set of concave mesh supports. When the external valve frame is released and deployed at the mitral valve position, regardless of the circumferential angle of the external valve frame, the anterior leaflet can always be positioned opposite to the outer surface of one set of concave mesh supports. During the catheter-directed implantation of the heart valve device, in order to align the outer surface of the concave mesh supports with the anterior leaflet, it is not necessary to adjust the circumferential orientation of the heart valve device before release, or only a small angle adjustment is needed, making the surgical operation simpler.

[0032] 3. In the heart valve device provided by the present invention, one end of two adjacent sets of mesh support units is connected by a apex, and the other end of two adjacent sets of mesh support units is connected by a circumferentially arranged circumferential connector, so that multiple sets of mesh support units can form an integral frame; since the adjacent convex mesh support and concave mesh support have hollow areas in the circumferential direction of the outflow side mesh frame, when the outer valve frame is released and radially expanded, the convex mesh support will not cause the concave mesh support to deform due to its own restoring force, so that the concave mesh support can more stably maintain the concave shape of the outer surface after radial expansion.

[0033] 4. In the heart valve device provided by the present invention, the number of angular struts in different strut groups gradually decreases from the inflow end to the outflow end. When the external valve frame is in a radially expanded state, the concave mesh support, the convex mesh support, and the circumferential connector can form a triangular valve frame hollow area. The formation of this valve frame hollow area can reduce the compression support on the anterior leaflet, and at the same time allow blood flow to pass smoothly, avoiding the obstruction of the left ventricular outflow tract caused by the excessive radial support force squeezing the anterior leaflet into the left ventricular outflow tract.

[0034] 5. The heart valve device provided by the present invention has a first row of barbs on the mesh support unit, which can better anchor the external valve frame to the annulus of the native mitral valve, thereby enabling the inflow-side mesh frame and outflow-side mesh frame of the external valve frame to better fit the native valve annulus with less impact on the ventricular structure.

[0035] 6. The heart valve device provided by the present invention has a second row of barbs at the apex of the second row of struts of the convex mesh stent, while the corresponding position of the concave mesh stent does not have a second row of barbs. The second row of barbs only on the convex mesh stent can make the external valve stent better anchored to the corresponding position of the posterior leaflet of the mitral valve or the ventricular wall.

[0036] 7. The heart valve device provided by the present invention has a valve frame connecting piece that can be fixed relative to the outer valve frame by passing sutures through the suture holes of the outer valve frame and the valve feet of the inner valve frame, and is connected to the delivery device for releasing the heart valve device through its release hole during compression insertion, so as to ensure that the outer valve frame is gradually released in the left ventricle as expected; moreover, the overall length of this valve stent in the axial direction is small, which can achieve a smaller size when compressing the catheter, making it more conducive to realizing transfemoral vein intervention.

[0037] 8. The heart valve device provided by the present invention has an inflow-side grid frame that bends outward in the radial direction relative to the outer valve frame at one end away from the outflow-side grid frame; the inflow-side grid frame includes multiple sets of grid groups that are connected and form a ring, and two adjacent sets of grid groups that form the same ring are connected at one vertices or along one side, and the vertices of the multiple sets of grid groups near the outflow-side grid frame are connected to the vertices of the top of the inflow-side grid frame; the outward bending of the upper end of the inflow-side grid frame relative to the radial direction of the outer valve frame creates a certain gap between the atrial-side outer valve frame and the inner valve frame, and provides a larger anchoring area between the atrial-side outer valve frame and the annulus of the native mitral valve, allowing the atrial-side outer valve frame to be better anchored to the annulus of the native mitral valve, thus preventing paravalvular leakage.

[0038] 9. The heart valve device provided by the present invention has a clamping member at the position of the concave mesh support, which allows the anterior leaflet to fit better against the outer valve support, reduces the squeezing of the anterior leaflet by the outer valve support, and reduces the obstruction of the left ventricular outflow tract.

[0039] 10. The heart valve device provided by the present invention has an inner valve frame and an outer valve frame that are sealed together on the atrial side by an inflow-side sealing skirt, thereby blocking blood flow on the ventricular and atrial sides and preventing paravalvular leakage.

[0040] 11. The heart valve device provided by the present invention has an inner valve frame with a structure similar to that of an aortic valve frame, which can play a good role in supporting the leaflet assembly; the inner and outer valve frames are connected by sutures through the suture holes of the valve frame connecting piece, which can maintain the stability and independence of the inner and outer valve frames; when the outer valve frame contracts and relaxes with the ventricle, the inner valve frame leaflet assembly can open and close stably without being excessively affected; at the same time, after valve replacement, the outer valve frame has a certain degree of compliance and will not compress the inner valve frame. Attached Figure Description

[0041] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0042] Figure 1 This is a three-dimensional structural diagram of the heart valve device in Embodiment 1 of the present invention; Figure 2 This is a front view of the heart valve device in Embodiment 1 of the present invention; Figure 3 This is a front view of the outer lobe frame in Embodiment 1 of the present invention; Figure 4 This is a bottom view of the outer lobe frame in Embodiment 1 of the present invention; Figure 5 This is a three-dimensional structural diagram of the outer valve frame in Embodiment 1 of the present invention; Figure 6 This is a schematic diagram of the structure of the valve frame connecting piece of the outer valve frame in Embodiment 1 of the present invention; Figure 7 This is a three-dimensional structural diagram of the inner valve frame in Embodiment 1 of the present invention; Figure 8 This is a three-dimensional structural diagram of the heart valve device in Embodiment 2 of the present invention; Figure 9 This is a front view of the heart valve device in Embodiment 2 of the present invention; Figure 10 This is a three-dimensional structural diagram of the outer valve frame in Embodiment 2 of the present invention; Figure 11 This is a schematic diagram of the structure of the outer petal frame connecting piece and clamping member in Embodiment 2 of the present invention; Figure 12 This is a front view of the outer lobe frame in Embodiment 2 of the present invention; Figure 13 This is a bottom view of the outer lobe frame in Embodiment 2 of the present invention; Figure 14This is a schematic diagram of the structure of the outer petal frame connecting piece and clamping member in Embodiment 3 of the present invention; Figure 15 This is a bottom view of the outer lobe frame in Embodiment 3 of the present invention; Figure 16 This is a top view of the outer petal frame in Embodiment 3 of the present invention.

[0043] Explanation of reference numerals in the attached figures: 1. Outer flap frame; 11. Inflow side mesh frame; 111. Inner skirt of outer flap frame; 112. Axial connector; 113. First flap frame support rod; 114. Second flap frame support rod; 12. Outflow side mesh frame; 121. Angled support rod; 122. First row of barbs; 123. Second row of barbs; 13. Flap frame connecting piece; 131. Connecting piece body; 132. Release hole; 133. Suture hole; 14. Circumferential connector; 15. Outwardly convex mesh support; 16. Inwardly concave mesh support; 17. Flap frame hollow area; 2. Inner valve frame; 21. Inflow side sealing skirt; 22. Inner valve frame skirt; 23. Leaflet suture hole; 24. Valve foot; 241. Valve foot suture hole; 25. Inner valve frame mesh frame; 3. Leaflet assembly; 4. Clamping component; 41. Curved support rod; 42. Middle skirt; 43. Curved short rod; 44. Arc-shaped round rod. Detailed Implementation

[0044] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0045] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0046] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0047] In transcatheter mitral valve replacement (TCVPR), an artificial heart valve is implanted into the patient's mitral valve via a catheter. The implanted artificial valve's frame supports the patient's own valve, and the artificial leaflets within the frame can open and close, replacing the function of the patient's own valve. During TCVPR, if the portion of the frame located in the left ventricle protrudes excessively, it can mechanically compress and push the anterior leaflet of the mitral valve into the left ventricular outflow tract, leading to postoperative complications such as left ventricular outflow tract obstruction. Therefore, a heart valve device is needed that minimizes the risk of left ventricular outflow tract obstruction under the compressive force of the anterior leaflet of the mitral valve.

[0048] Example 1 like Figures 1 to 7 The illustration shows a heart valve device comprising an outer valve frame 1, an inner valve frame 2, and a leaflet assembly 3. The outer valve frame 1 surrounds the outer periphery of the inner valve frame 2, and the leaflet assembly 3 is connected to the inner side of the inner valve frame 2. The leaflet assembly 3 includes three artificial leaflets capable of opening and closing. After the heart valve device provided by this invention is implanted into the mitral valve location, the leaflet assembly 3 replaces the autologous leaflets, thus achieving the effect of treating or improving stenosis and regurgitation caused by primary mitral valve disease.

[0049] like Figure 1 , Figure 5 and Figure 7 As shown, the outer flap 1 can be made of any of the various suitable self-expanding materials known in the art (e.g., nickel-titanium alloys). The inner flap 2 can be made of any of the various suitable malleable expansion materials known in the art (e.g., cobalt-chromium alloys, etc.) or self-expanding materials (e.g., nickel-titanium alloys).

[0050] Both the outer valve frame 1 and the inner valve frame 2 are annular frame structures with multiple repeating polygonal grids, and both can contract and deform radially. When the outer valve frame 1 and the inner valve frame 2 are made of self-expanding materials (e.g., nickel-titanium alloy) or malleably expandable materials, the outer valve frame 1, the inner valve frame 2, and the leaflet assembly 3 can be radially compressed to a compressed state and confined in this compressed state by insertion into a catheter. After the heart valve device is implanted in the human heart valve location, the heart valve device can be pushed out from the catheter, allowing the outer valve frame 1, the inner valve frame 2, and the leaflet assembly 3 to expand to their functional dimensions via self-expansion or balloon expansion. After the heart valve device is delivered through the catheter into the annulus of the human heart valve, the outer valve frame 1 and the inner valve frame 2 can expand radially outward to... Figure 1 As shown, the external valve frame 1 has an inflow end and an outflow end. The inflow end of the external valve frame 1 is located on the atrial side, and the outflow end is located on the ventricular side. There is a gap between the external valve frame 1 and the internal valve frame 2, and the compliance of the external valve frame 1 is greater than that of the internal valve frame 2. When the external valve frame 1 contracts and relaxes with the ventricle, the external valve frame 1 is more flexible due to its greater compliance, and the external valve frame 1 will not compress the internal valve frame 2. The leaflet assembly 3 inside the internal valve frame 2 can open and close stably without being affected by the external valve frame 1.

[0051] like Figure 1 , Figure 5 and Figure 7 As shown, the inner side of the outer flap 1 is connected to the inner side skirt 111. The inner flap 2 includes an inner flap mesh frame 25 and an inner flap skirt 22. The inner flap mesh frame 25 is in the shape of a cylindrical mesh, and the inner flap skirt 22 is sewn to the inner or outer side of the inner flap mesh frame 25.

[0052] like Figure 1 , Figure 5 and Figure 7 As shown, the heart valve device also includes an inflow-side sealing skirt 21. The inflow-side sealing skirt 21 is sewn to the inflow end of the inner valve frame mesh frame 25 and the inflow end of the outer valve frame 1, sealing the space between the inner valve frame 2 and the outer valve frame 1. In some embodiments, the inflow-side sealing skirt 21 seals the inner side skirt 111 of the outer valve frame 1 and the inflow-side sealing skirt 21 of the inner valve frame 2, forming a circumferential seal at the inflow end of the inflow end in the gap between the outer valve frame 1 and the inner valve frame 2.

[0053] Specifically, the inner skirt 111 of the outer valve frame, the inner skirt 22 of the inner valve frame, and the inflow-side sealing skirt 21 are made of PET or other polymer materials, which serve as a seal to prevent perivalvular leakage.

[0054] like Figure 1 , Figure 5 and Figure 7As shown, in some embodiments, the inner valve frame mesh frame 25 has three leaflet suture holes 23 evenly arranged circumferentially. The three leaflets of the leaflet assembly 3 are respectively sutured to the inner valve frame skirt 22 under the guidance of the leaflet suture holes 23. The leaflet suture holes 23 can ensure that the leaflet suture position is fixed and the suture effect is consistent, ensuring the hemodynamic stability of the leaflets. In this way, the inner valve frame 2 can support the leaflet assembly 3 well.

[0055] like Figure 1 , Figure 5 and Figure 7 As shown, the outflow end of the outer valve frame 1 is provided with a valve frame connecting piece 13, and the outflow end of the inner valve frame mesh frame 25 is provided with a valve foot 24. The valve frame connecting piece 13 and the valve foot 24 are connected and fixed by sutures to maintain the stability and independence of the inner valve frame 2 and the outer valve frame 1. The inner valve frame 2 and the outer valve frame 1 are sealed at the inflow end by an inflow-side sealing skirt 21, which can block the blood between the ventricular side and the atrial side, thereby preventing paravalvular leakage.

[0056] like Figure 2 As shown, the external valve frame 1 includes an inflow-side grid frame 11 and an outflow-side grid frame 12 arranged sequentially from the inflow end to the outflow end; both the inflow-side grid frame 11 and the outflow-side grid frame 12 are frame structures composed of multiple quadrilateral or near-quadrilateral repeating grids. The outflow-side grid frame 12 is generally cylindrical with a central outward protrusion, and the end of the inflow-side grid frame 11 away from the outflow-side grid frame 12 extends radially outward. After the heart valve device is delivered to the valve annulus position of the human heart valve, the inflow-side grid frame 11 of the external valve frame 1 is located on the atrial side, and the outflow-side grid frame 12 of the external valve frame 1 is located on the ventricular side. The inflow-side grid frame 11 and the outflow-side grid frame 12 form annular recesses on the outer periphery of the external valve frame 1 suitable for clamping the valve annulus of the native mitral valve.

[0057] like Figure 2 As shown, one end of the outflow side grid frame 12 is connected to the inflow side grid frame 11, and the petal frame connecting piece 13 is located at the outflow end of the outflow side grid frame 12. Two adjacent petal frame connecting pieces 13 are connected as one unit by a circumferentially arranged circumferential connector 14.

[0058] like Figure 2 , Figure 3 and Figure 4As shown, the outflow-side mesh frame 12 includes multiple sets of mesh support units connected continuously along its circumference and forming a ring. Each mesh support unit includes a convex mesh support 15 and a concave mesh support 16, with the outer surface of the concave mesh support 16 recessed relative to the outer surface of the convex mesh support 15. With this structural form of the outflow-side mesh frame 12, the anterior leaflet of the native mitral valve can conform to the outer side of the concave mesh support 16. Compared to the prior art where the anterior leaflet of the native mitral valve abuts against the surface of the convex mesh support of the outer valve frame 1, this reduces the compression of the anterior leaflet by the outer valve frame 1, preventing the outer valve frame 1 from pushing the anterior leaflet towards the left ventricular outflow tract and thus reducing the area of ​​the left ventricular outflow tract, thereby avoiding surgical complications such as left ventricular outflow tract obstruction.

[0059] like Figure 2 , Figure 3 and Figure 4 As shown, in some embodiments, the outflow-side mesh frame 12 includes three sets of convex mesh supports 15 and three sets of concave mesh supports 16 alternately connected along its circumferential direction. The convex mesh supports 15 and concave mesh supports 16 are arranged at 60° intervals, and the two sets of concave mesh supports 16 are arranged at 120° intervals. The anterior leaflet of the native mitral valve can be attached to the outer surface of any set of concave mesh supports 16. When the external valve frame 1 is released and deployed at the position of the mitral valve, regardless of the circumferential angle of the external valve frame 1, the anterior leaflet of the native mitral valve can always be positioned opposite to the outer surface of one set of concave mesh supports 16. During the transcatheter implantation of the heart valve device, only the circumferential orientation of the heart valve device before release needs to be finely adjusted so that the concave surface of any set of concave mesh supports 16 is aligned with the anterior leaflet position, making the surgical operation simpler.

[0060] It can be understood here that the number of concave mesh supports is one or more sets, and the number and occupancy angle of concave mesh supports 16 and convex mesh supports 15 can be adjusted as needed. The number of concave mesh supports 16 and convex mesh supports 15 can be the same or different. When there are multiple sets of concave mesh supports 16 and convex mesh supports 15, and the number is the same, the angle occupied by each set of concave mesh supports 16 in the circumferential direction of the outflow side mesh frame 12 is the same, and the angle occupied by each set of convex mesh supports 15 in the circumferential direction of the outflow side mesh frame 12 is the same; the angle occupied by each set of concave mesh supports 16 and each set of convex mesh supports 15 in the circumferential direction of the outflow side mesh frame 12 may be the same or different. For example, there are two concave mesh stents 16 and two convex mesh stents 15. The occupancy angle of a single concave mesh stent 16 is approximately 60°, and the occupancy angle of a single convex mesh stent 15 is approximately 120°. During the operation, the circumferential orientation of the heart valve device is adjusted at a small angle before release, so that the outer surface of one of the concave mesh stents 16 is aligned with the anterior leaflet of the native mitral valve. Moreover, setting the occupancy angle of a single concave mesh stent 16 to approximately 60° not only allows it to conform to the anterior leaflet of the native mitral valve, reducing the extrusion of the anterior leaflet, but also maximizes the radial support force of the outer valve stent 1. At the same time, the moderate compression of the anterior leaflet of the native mitral valve by the outer valve stent 1 creates a more secure anchoring effect, reducing the risk of displacement.

[0061] like Figure 2 , Figure 3 and Figure 5As shown, one end of the convex mesh support 15 and the concave mesh support 16 is connected to the inflow side mesh frame 11. Two adjacent sets of convex mesh supports 15 and concave mesh supports 16 are connected at one apex and have a hollow area in the circumferential direction of the outflow side mesh frame 12. Each set of convex mesh supports 15 or concave mesh supports 16 has a petal frame connecting piece 13 at the other end away from the inflow side mesh frame 11. A circumferential connector 14 is integrally connected between two adjacent petal frame connecting pieces 13. The circumferential connector 14 and the other parts of the outer petal frame 1 are integral structures made of the same material. Multiple circumferential connectors 14 connect the outflow ends of multiple sets of convex mesh supports 15 and multiple sets of concave mesh supports 16 into a whole. This configuration allows multiple sets of convex mesh stents 15 and multiple sets of concave mesh stents 16 to form an integral frame. Because there are open areas between adjacent convex mesh stents 15 and concave mesh stents 16, when the outer valve frame 1 is released and radially expanded, the convex mesh stents 15 will not deform due to their own restoring force, allowing the concave mesh stents 16 to maintain a more stable concave shape on their outer surface after radial expansion. The exterior of the concave mesh stents 16 can stably provide a recessed space to accommodate the anterior leaflet of the original mitral valve, reducing pressure on the anterior leaflet of the original mitral valve. Furthermore, it allows blood to better enter the left ventricular outflow tract from this area.

[0062] like Figure 2 , Figure 3 and Figure 5 As shown, both the concave mesh support 16 and the convex mesh support 15 include multiple rows of support rods connected axially. Each row of support rods includes one angled support rod 121 or multiple angled support rods 121 connected circumferentially at the top. The number of angled support rods 121 in different rows of support rods gradually decreases from the inflow end to the outflow end. The angled support rod 121 includes two rods arranged at an angle. When the outer valve frame 1 is in a radially extended state, adjacent concave mesh supports 16, convex mesh supports 15 and circumferential connectors 14 enclose a triangular valve frame hollow area 17. The formation of multiple valve frame hollow areas 17 on the outer valve frame 1 can reduce the compression support of the outer valve frame 1 on the anterior leaflet of the native mitral valve, and avoid obstruction of the left ventricular outflow tract caused by excessive convex valve frames of the outer valve frame 1 squeezing the anterior leaflet of the native mitral valve towards the left ventricular outflow tract.

[0063] like Figure 2 , Figure 3 and Figure 5As shown, in some specific embodiments, each set of concave grid support 16 and convex grid support 15 includes three rows of support rods connected axially. The top first row of support rods includes three angled support rods 121, the middle second row of support rods includes two angled support rods 121, and the bottom third row of support rods includes only one angled support rod 121. Adjacent angled support rods 121 in the same row are connected at their apex. In adjacent rows of support rods, the apex of the angled support rod 121 in the next row is connected to the intersection point of the angled support rod 121 in the previous row. It should be noted that the "intersection point" in this section refers to the meeting point of two support rods in the angled support rod 121, and the "apex" in this section refers to the end of the two support rods in the angled support rod 121 furthest from the intersection point.

[0064] like Figure 2 , Figure 3 and Figure 5 As shown, the concave mesh support 16 and the convex mesh support 15 have a first row of barbs 122 at all vertices of the first row of support rods closest to the inflow-side mesh frame 11. Multiple barbs in the first row of barbs 122 are distributed equidistantly around the circumference of the outer valve frame 1. The first row of barbs 122 pierces the soft tissue of the native mitral valve, anchoring the outer valve frame 1 to the annulus of the native mitral valve. Simultaneously, it fixes and covers the leaflets of the native mitral valve to the outer periphery of the outer valve frame 1, with the edges of the leaflets of the native mitral valve closely adhering to the outflow-side mesh frame 12 of the outer valve frame 1. This arrangement allows the outer valve frame 1 to be better anchored to the annulus of the native mitral valve, enabling the inflow-side mesh frame 11 and the outflow-side mesh frame 12 of the outer valve frame 1 to better fit the native valve annulus with minimal impact on the ventricular structure, effectively preventing paravalvular leakage.

[0065] like Figure 2 , Figure 3 and Figure 5 As shown, the convex mesh support 15 has a second row of barbs 123 at the apex of the second row of support rods adjacent to the first row of support rods, while the concave mesh support 16 does not have a second row of barbs 123 at the corresponding position. The second row of barbs 123 is used to anchor the external valve frame 1 to the posterior leaflet of the native mitral valve or the ventricular wall. The second row of barbs 123 provided only on the convex mesh support 15 allows the external valve frame 1 to be better anchored to the corresponding position of the posterior leaflet of the native mitral valve or the ventricular wall.

[0066] like Figure 2 and Figure 5As shown, the end of the inflow-side grid frame 11 away from the outflow-side grid frame 12 bends outward in the radial direction relative to the outer valve frame 1. The inflow-side grid frame 11 includes multiple sets of grid groups that are connected and form a ring. In the multiple sets of grid groups forming the same ring, two adjacent sets of grid groups are connected by a vertex or a side. The vertices of the multiple sets of grid groups near the outflow-side grid frame 12 are connected to the vertices of the top of the inflow-side grid frame 11. The outward bending of the upper end of the inflow-side grid frame 11 relative to the radial direction of the outer valve frame 1 creates a certain gap between the outer valve frame 1 and the inner valve frame 2. This provides a larger anchoring area between the atrial-side outer valve frame 1 and the annulus of the native mitral valve, allowing the atrial-side outer valve frame 1 to be better anchored to the annulus of the native mitral valve, preventing paravalvular leakage.

[0067] like Figure 5 As shown, the grid group includes a first petal support rod 113, an axial connector 112, and a second petal support rod 114. Both the first petal support rod 113 and the second petal support rod 114 are arranged at an included angle and are both curved outwards. The axial connector 112 connects the apex of the first petal support rod 113 and the apex of the second petal support rod 114. Multiple first petal support rods 113 from multiple grid groups are connected sequentially to form a first row of annular supports arranged circumferentially. Multiple second petal support rods 114 from multiple grid groups are connected sequentially to form a second row of annular supports arranged circumferentially.

[0068] like Figure 2 , Figure 3 and Figure 5 As shown, the inner skirt 111 of the outer valve frame covers the area of ​​the outer valve frame 1 formed by the first row of annular supports, axial connectors 112, the second row of annular supports, and the first row of support rods of the outflow side grid frame 12 of the inflow side grid frame 11. The second valve frame support rod of the inflow side grid frame 11 is used to abut against the valve annulus of the original mitral valve.

[0069] like Figure 2 , Figure 3 and Figure 5As shown, the circumferential connector 14 is a foldable and bendable elastic support rod. When the outer petal frame 1 is in a radially contracted state, the circumferential connector 14 is compressed, bent, and folded in the area between the concave mesh support 16 and the convex mesh support 15. When the outer petal frame 1 is in a radially extended state, the circumferential connector 14 unfolds under its own restoring force and is supported between two adjacent petal frame connecting pieces 13. This foldable and bendable circumferential connector 14 does not require additional space when the outer petal frame 1 is radially contracted, and can be supported between the outflow sides of two adjacent sets of concave mesh supports 16 and convex mesh supports 15 when the outer petal frame 1 is radially extended, enhancing the radial stiffness of the outer petal frame 1. This makes the multiple sets of concave mesh supports 16 and multiple sets of convex mesh supports 15 form a ring shape after unfolding, improving the overall structural stability of the outer petal frame 1 after unfolding.

[0070] like Figure 5 and Figure 6 As shown, in some embodiments, valve frame connectors 13 are distributed at 60° intervals along the circumference of the outer valve frame 1. Each valve frame connector 13 includes a connector body 131, which has a release hole 132 and three suture holes 133. The valve frame connector 13 is connected to the delivery device for releasing the heart valve through the release hole 132. Figure 7 As shown, the outflow end of the inner valve frame 2 has six circumferentially arranged valve feet 24, each valve foot 24 having multiple valve foot suture holes 241. The valve frame connecting piece 13 secures the outer valve frame 1 and the inner valve frame 2 together with sutures passing through the suture holes 133 and 241 of the valve feet. When the heart valve device is pressed into the catheter for insertion, it is connected to the delivery device that releases the heart valve device through the release hole 132 of the valve frame connecting piece 13, ensuring that the outer valve frame 1 is gradually released in the left ventricle as expected. Moreover, this valve stent has a small overall axial length, allowing for a smaller size when pressed into the catheter, which is beneficial for the heart valve device to be inserted via the femoral vein.

[0071] In this heart valve device, the outflow side mesh frame 12 is formed by three sets of convex mesh supports 15 and three sets of concave mesh supports 16 connected circumferentially to form a ring. The outer surface of the concave mesh support 16 is concave relative to the outer surface of the convex mesh support 15. This structure allows the anterior leaflet of the native mitral valve to better fit the outer surface of the concave mesh support 16. Compared with the prior art where the anterior leaflet of the native mitral valve abuts against the convex surface of the outer valve frame 1, this reduces the compression of the anterior leaflet by the outer valve frame 1, avoids squeezing the anterior leaflet into the left ventricular outflow tract, thus reducing the area of ​​the left ventricular outflow tract and preventing left ventricular outflow tract obstruction.

[0072] Example 2 like Figures 8 to 13The heart valve device shown differs from Embodiment 1 in that the outflow ends of the three sets of concave mesh stents 16 are all connected to elastically bendable clamping members 4. When the external valve frame 1 is in a radially contracted state, the three clamping members 4 are straightened outwards towards the outflow end along the central axis of the external valve frame 1. When the internal and external valve frames 1 are released and deployed in the ventricle, and the external valve frame 1 is in a radially deployed state, the three clamping members 4 bend outwards towards the external side of the external valve frame 1. One of the clamping members 4 presses the anterior leaflet of the native mitral valve against the outside of the concave mesh stent 16 and cooperates with the concave mesh stent 16 to clamp the anterior leaflet of the native mitral valve. The clamping members 4 at the location of the concave mesh stent 16 allow the anterior leaflet of the native mitral valve to better conform to the external valve frame 1, reducing the squeezing of the anterior leaflet of the native mitral valve by the external valve frame 1 and reducing the obstruction of the left ventricular outflow tract. Figures 8 to 13 As shown, the clamping member 4 includes a pair of curved support rods 41 and a middle skirt 42. One end of the pair of curved support rods 41 is integrally connected to the concave mesh support 16 near the valve frame connecting piece 13, and the other ends of the pair of curved support rods 41 are connected as a single unit. The middle skirt 42 is connected between the pair of curved support rods 41 and covers the space enclosed by the pair of curved support rods 41. This clamping member 4 has fewer rods, making it easy to adjust the curvature when passing through the atrial septum.

[0073] Example 3 like Figures 14 to 16 The heart valve device shown differs from Embodiment 2 in that the clamping member 4 includes a pair of curved short rods 43, an arc-shaped round rod 44, and a middle skirt 42. One end of the pair of curved short rods 43 is integrally connected to the concave mesh support 16 near the valve frame connecting piece 13. The two ends of the arc-shaped round rod 44 are respectively spot-welded to the other ends of the pair of curved short rods 43 or pressed together with a metal fitting. The middle skirt 42 is connected to the arc-shaped round rod 44 and covers the space enclosed by the pair of curved short rods 43 and the arc-shaped round rod 44.

[0074] In summary, the heart valve device provided in the embodiments of the present invention mainly has the following beneficial effects: 1. Reduce the impact on the left ventricular outflow tract: The concave mesh stent 16 or the concave mesh stent 16 with clamp 4 can allow the anterior leaflet of the mitral valve to fit against the outer valve stent 1, reducing the squeezing of the anterior leaflet by the outer valve stent 1, thereby reducing the obstruction of the left ventricular outflow tract. 2. Anchoring and Sealing: The first row of barbs 122 circumferentially arranged on the outflow side mesh frame 12 of the external valve frame 1 allows for better fit of the outflow side mesh frame 12 to the valve annulus with minimal impact on the ventricular structure. The clamping member 4 in Embodiments 2 and 3 can clamp the anterior leaflet of the mitral valve, simultaneously anchoring the valve frame and reducing obstruction. The double-layered skirt in Embodiment 3 effectively prevents paravalvular leakage.

[0075] 3. Compressibility: Compared to existing heart valve stents, this barbed external valve stent 1 uses less material overall, and the external valve stent 1 and the entire heart valve stent can be compressed into a smaller transcatheter.

[0076] 4. Catheter Bending Capability: In Example 1, the axial length of the cardiac valve stent is relatively small, making it easy for the catheter containing the stent to bend when passing through the atrial septum. In Example 2, although the cardiac valve stent has an everted clamp 4 that can be straightened when pressed inside the catheter, resulting in a slightly longer overall length compared to the stent in Example 1, the clamp 4 has fewer rods, making it easy for the catheter containing the stent to bend when passing through the atrial septum. In Example 3, the clamp 4 of the cardiac valve stent uses a combination of a pair of short rods 43 with a slight bend and a semi-arc-shaped rod 44. The length of the cardiac valve stent in Example 3 is similar to that in Example 1, making it easy for the catheter containing the stent to bend when passing through the atrial septum.

[0077] 5. Stability and Independence of Inner and Outer Valves: The outflow ends of the outer valve frame 1 and the inner valve frame 2 are fixed by sutures passing through suture holes 133, which maintains the overall stability of the heart valve stent. The inner valve frame 2 adopts a structure similar to the aortic valve frame, which can effectively support the leaflet assembly 3. When the outer valve frame 1 contracts and relaxes with the ventricle, the leaflet assembly 3 in the inner valve frame 2 can open and close stably without being excessively affected by the morphology of the original valve annulus or the outer valve frame 1; at the same time, after heart valve stent replacement, the outer valve frame 1 has a certain degree of compliance and will not compress the inner valve frame 2.

[0078] 6. Safety of the short valve frame: The outflow side mesh frame 12 with barbs at the waist can reduce the length of the external valve frame 1 in the ventricle while ensuring its corresponding function, and can minimize the impact on the ventricle.

[0079] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A heart valve device, characterized in that, It includes an outer petal frame (1), which is an annular mesh frame. The outer petal frame (1) has an inflow end and an outflow end. The outer petal frame (1) includes an inflow side mesh frame (11) and an outflow side mesh frame (12) arranged sequentially from the inflow end to the outflow end. The outflow side grid frame (12) includes multiple sets of grid support units that are connected and enclosed in a ring along its circumference. The grid support unit includes an outwardly convex grid support (15) and an inwardly concave grid support (16). The outer surface of the inwardly concave grid support (16) is recessed relative to the outer surface of the outwardly convex grid support (15).

2. The heart valve device according to claim 1, characterized in that, The outflow side grid frame (12) includes three sets of outwardly convex grid supports (15) and three sets of inwardly concave grid supports (16) that are alternately connected along their circumferential direction.

3. The heart valve device according to claim 1, characterized in that, One end of each of the multiple sets of grid support units is connected to the inflow side grid frame (11). The concave grid support (16) and the adjacent convex grid support (15) have a hollow area in the circumferential direction of the outflow side grid frame (12). The other end of the multiple sets of grid support units away from the inflow side grid frame (11) is connected as a whole by a circumferentially arranged circumferential connector (14).

4. The heart valve device according to claim 3, characterized in that, The grid support unit includes multiple rows of support rods connected from the inflow end to the outflow end. Each row of support rods includes one angled support rod (121) or multiple angled support rods (121) connected at the top. The number of angled support rods (121) in different rows of support rods gradually decreases from the inflow end to the outflow end. When the outer petal frame (1) is in a radially expanded state, two adjacent grid support units and the circumferential connector (14) connecting the two adjacent grid support units enclose a triangular petal frame hollow area (17).

5. The heart valve device according to claim 4, characterized in that, The first row of barbs (122) is provided at the apex of the first row of support rods closest to the inflow side grid frame (11) of the grid support unit, and / or, the second row of support rods adjacent to the first row of support rods in the convex grid support (15) is provided at the apex of the second row of support rods (123).

6. The heart valve device according to claim 1, characterized in that, At least one set of the concave mesh support (16) is connected to a clamping member (4); when the outer valve support (1) is in a radially contracted state, a plurality of clamping members (4) are straightened toward the outflow end along the central axis of the outer valve support (1); when the outer valve support (1) is in a radially expanded state, a plurality of clamping members (4) are bent toward the outside of the outer valve support (1), and one of the clamping members (4) presses the anterior leaflet of the native mitral valve against the outside of the concave mesh support (16) and cooperates with the concave mesh support (16) to clamp the anterior leaflet of the native mitral valve.

7. The heart valve device according to claim 6, characterized in that, The clamping member (4) includes a pair of curved support rods (41) and a middle skirt (42). One end of the pair of curved support rods (41) is connected to the concave mesh support (16), and the other end of the pair of curved support rods (41) is connected to the middle skirt (42). The middle skirt (42) is connected between the pair of curved support rods (41) and covers the space enclosed by the pair of curved support rods (41); or, The clamping member (4) includes a pair of curved short rods (43), an arc-shaped round rod (44), and a middle skirt (42). One end of the pair of curved short rods (43) is connected to the concave grid support (16), and both ends of the arc-shaped round rod (44) are respectively connected to the other ends of the pair of curved short rods (43). The middle skirt (42) is connected to the arc-shaped round rod (44) and covers the space enclosed by the pair of curved short rods (43) and the arc-shaped round rod (44).

8. The heart valve device according to claim 4, characterized in that, Each of the multiple sets of grid support units is provided with a petal frame connecting piece (13) at the other end away from the inflow side grid frame (11), and two adjacent petal frame connecting pieces (13) are connected as one unit by a circumferentially arranged circumferential connector (14).

9. The heart valve device according to claim 8, characterized in that, The circumferential connector (14) is a foldable and bendable elastic support rod. When the outer petal frame (1) is in a radially contracted state, the circumferential connector (14) is compressed, bent, and folded in the area between the concave mesh support (16) and the convex mesh support (15). When the outer petal frame (1) is in a radially extended state, the circumferential connector (14) unfolds under its own restoring force and is supported between two adjacent petal frame connecting pieces (13).

10. The heart valve device according to claim 1, characterized in that, The heart valve device also includes an inner valve frame (2) surrounded by the outer valve frame (1), and an inflow-side sealing skirt (21) is sealingly connected between the inflow end of the inner valve frame (2) and the inflow end of the outer valve frame (1), and the inflow-side sealing skirt (21) forms a circumferential seal on the outer periphery of the inner valve frame (2).

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