Replacement valve device

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a valve replacement device which comprises a support mechanism, a valve replacement mechanism and a valve replacement mechanism. The valve leaflet mechanism is located in the inner frame and comprises a plurality of artificial valve leaflets; the valve leaflet mechanism further comprises a plurality of valve leaflet connecting structures, each valve leaflet connecting structure is provided with a connecting lug and a connecting piece, the two sides of the outflow end of each artificial valve leaflet are each connected with one connecting lug, and the two ends of each connecting piece are arranged in the connecting lugs connected with every two adjacent artificial valve leaflets respectively. And the outer layer of the connecting lug and the connecting layer clamp the connecting sheet so as to connect two adjacent artificial valve leaflets. The outflow end of the artificial valve leaflet is connected with the inner frame through the valve leaflet connecting structure, when the valve leaflet connecting structure is connected with the inner frame through a suture line, the suture line acts on the ear connecting parts of the outer layer and the inner layer, and the connecting layer only needs to bear tearing force from the artificial valve leaflet and does not need to bear external force such as tearing force similar to the suture line any more; and the service life of the artificial valve leaflet is prolonged.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a valve replacement device. Background Art

[0002] Heart valves are the basic structure of the heart, and severe valvular diseases can lead to death. Heart valves refer to the valves between the atria and ventricles or between the ventricles and arteries. Their main function is to prevent blood from flowing back and ensure that blood flows from the atria to the ventricles (or from the ventricles to the aorta / pulmonary artery). There are four types of heart valves based on their shape and position: the mitral valve between the left ventricle and the left atrium, the tricuspid valve between the right ventricle and the right atrium, the aortic valve between the left ventricle and the aorta, and the pulmonary valve between the right ventricle and the pulmonary artery. Heart valves may suffer from insufficiency (regurgitation), valvular stenosis and other diseases due to congenital or acquired inflammation and other reasons, affecting the patient's quality of life, and in severe cases may be life-threatening.

[0003] An artificial biological valve is a device for treating the above diseases. Biological valves mostly use bovine pericardium or porcine pericardium as the opening and closing artificial valve leaflet components. Since the pericardium is soft, the connection structure of the outflow ends of adjacent artificial valve leaflets will directly affect the opening and closing performance or anti-reflux performance of the valve leaflets. Summary of the invention

[0004] The present invention aims to provide a valve replacement device in view of the technical problem that after two adjacent leaflets are sutured and connected to a stent, the existing leaflet connection structure is prone to cause reflux due to the movement of the leaflets or the stent, and the present invention aims to provide a valve replacement device.

[0005] In order to solve the above technical problems, one aspect of the present invention provides a valve replacement device, the valve replacement device comprising:

[0006] A support mechanism, the support mechanism comprising an outer frame and an inner frame connected to the outer frame;

[0007] a valve leaflet mechanism, the valve leaflet mechanism is located in the inner frame, and the valve leaflet mechanism includes a plurality of artificial valve leaflets;

[0008] The leaflet mechanism further comprises:

[0009] A plurality of leaflet connection structures, wherein the leaflet connection structures have connecting ears and connecting pieces, each artificial leaflet is connected to a connecting ear on both sides of the outflow end, the connecting ears have at least three layers connected in one piece, an intermediate layer in the connecting ears is connected to the artificial leaflets as a connecting layer, and the two ends of the connecting piece are respectively arranged in the connecting ears connecting two adjacent artificial leaflets, and the connecting piece is clamped by the outer layer of the connecting ears and the connecting layer to connect the two adjacent artificial leaflets;

[0010] A plurality of artificial valve leaflets are connected in sequence through the valve leaflet connection structure to form a middle structure that can be opened and closed in one direction.

[0011] Optionally, in the valve replacement device as described above, a plurality of leaflet suture holes are provided on the inner frame, and the coupling ears and the connecting pieces are located on the inner side of the inner frame and are sutured and connected to the inner frame through the leaflet suture holes.

[0012] Optionally, in the valve replacement device as described above, the leaflet suture hole is a long strip through hole or a waist-shaped hole;

[0013] Alternatively, the leaflet suture hole is composed of a plurality of suture sub-holes, and the plurality of suture sub-holes are distributed along the axial direction.

[0014] Optionally, in the valve replacement device as described above, the connecting piece is made of a polymer material, such as PET or other materials.

[0015] Optionally, in the valve replacement device as described above, a median piece is provided on the connecting piece, and the median piece is located at the middle outflow end side of the connecting piece.

[0016] Optionally, in the replacement valve device as described above, at least three layers of the ear are sutured by ear sutures;

[0017] When a connecting piece is provided, the at least three-layer structure of the connecting ear and the connecting piece are sewn together by connecting ear sewing lines.

[0018] Optionally, in the valve replacement device as described above, the ear comprises:

[0019] an ear portion, one end of which is connected to the artificial valve leaflet;

[0020] a folding ear, the inflow end of the folding ear being connected to the outflow end of the other end of the ear;

[0021] After the ear is folded 180° from the circumferential middle to the distal axis, the folded ear is bent 180° from the connection position with the ear to the proximal axis side to form the connecting ear.

[0022] Optionally, in the valve replacement device as described above, one end of the ear is integrally connected to the artificial valve leaflet, and the inflow end of the folded ear is integrally connected to the outflow end of the other end of the ear.

[0023] Optionally, in the replacement valve device as described above, the folding ear includes an inner folding ear and an outer folding ear. After the ear is folded 180° from the circumferential middle to the distal axis, the inner folding ear and the outer folding ear are stacked together, so that in the formed connected ear, the proximal side of the ear forms a two-layer structure.

[0024] Optionally, in the valve replacement device as described above, an avoidance groove is provided between the inner folding ear and the outer folding ear.

[0025] Optionally, in the valve replacement device as described above, the length of the outer folded ear is greater than the length of the inner folded ear, and when the inner folded ear and the outer folded ear are stacked together, the ends of the inner folded ear and the outer folded ear are flush.

[0026] Optionally, in the valve replacement device as described above, a clamping ear is provided on the outer side of the folded ear, and after the ear portion and the folded ear are folded to form the connecting ear, the clamping ear is connected to the side edge of the artificial valve leaflet.

[0027] Optionally, in the valve replacement device as described above, the width of the clip ear located on the side of the artificial valve leaflet decreases from the outflow end to the inflow end of the artificial valve leaflet.

[0028] Optionally, in the valve replacement device as described above, when the folded ear includes an inner folded ear and an outer folded ear, the clamping ear is arranged on the outer side of the outer folded ear;

[0029] Or, when the folding ear includes an inner folding ear and an outer folding ear, the clip ear is arranged on the inner side of the inner folding ear;

[0030] Optionally, in the valve replacement device as described above, when the folded ear includes an inner folded ear and an outer folded ear, the clamping ear is arranged on the inner side of the inner folded ear, and the clamping ear is connected to the outflow end of the artificial valve leaflet.

[0031] Optionally, in the valve replacement device as described above, the inner frame comprises:

[0032] An inner frame body, a hollow cylindrical structure consisting of several layers of inner frame grids;

[0033] A plurality of connecting rods are evenly connected to the inflow end of the inner frame body along the circumferential direction, and the connecting rods are used to connect with the far end of the external conveying system. The inflow end of the inner frame does not exceed the inflow end of the outer frame in the axial direction.

[0034] Optionally, in the valve replacement device as described above, the inflow ends of the plurality of connecting rods are obliquely arranged at the inflow end of the inner frame body to form a gathering structure that gathers from the outflow end to the inflow end.

[0035] Optionally, in the valve replacement device as described above, a connector is provided at the inflow end of the connecting rod, and the connector may be a clamping connector with a circular, elliptical or rectangular structure.

[0036] Optionally, in the aforementioned replacement valve device, the replacement valve device further comprises:

[0037] A film coating mechanism, comprising an inner frame film coating, which is coated on the inner frame;

[0038] The connector is provided with a connector through hole, and the inflow end of the inner frame is connected to the external conveying system by passing a pull wire through the connector through hole.

[0039] Optionally, in the aforementioned replacement valve device, the replacement valve device further comprises:

[0040] A plurality of barbs are evenly arranged on the outer peripheral surface of the outer frame along the circumferential direction, and a barb opening facing the inflow end is formed between the barbs and the outer frame.

[0041] Optionally, in the valve replacement device as described above, the barbs include:

[0042] Two barbed rods, one end of the two barbed rods first converges inward from the outflow end to the inflow end and then expands outward and then smoothly connects to form an inverted V-shaped structure with rounded corners, the other ends of the two barbed rods are bent inward toward the inflow end and are respectively connected to the outer peripheral surface of the outer frame, so that the barbs form the barbed openings and the barbed openings have a smoothly transitioned shrinking structure and an outward expansion structure from the outflow end to the inflow end.

[0043] Optionally, in the valve replacement device as described above, the outer frame comprises:

[0044] An external frame body, a hollow cylindrical structure consisting of several layers of external frame grids;

[0045] A plurality of external connection blocks are evenly connected to the outflow end of the outer frame body along the circumferential direction, and the outer frame is connected to the inner frame through the external connection blocks;

[0046] The outflow end of the barb in the compressed state does not exceed the outflow end of the outer connecting block.

[0047] Optionally, in the valve replacement device as described above, the barb is a bent rod, which includes a connecting end, a bent portion and a free end, the connecting end is connected to the outer frame, and the bent portion and the free end form the barb opening.

[0048] Optionally, in the valve replacement device as described above, the rod width from the curved portion to the free end is greater than the rod width from the curved portion to the connecting end.

[0049] Optionally, in the valve replacement device as described above, the rod width from the curved portion to the free end is equal to the rod width from the curved portion to the connecting end, and a stabilizing plate is provided on the curved rod between the curved portion and the free end, and the width of the stabilizing plate is greater than the rod width of the curved rod.

[0050] Optionally, in the valve replacement device as described above, the shape of the stabilizing plate can be rectangular, semicircular, circular or crescent-shaped.

[0051] Optionally, in the valve replacement device as described above, there are one or more stabilizing plates, and the stabilizing plates are arranged at any position between the curved portion and the free end.

[0052] Optionally, in the valve replacement device as described above, when there is one stabilizing plate, one stabilizing plate is located at the end of the free end or at a position between the curved portion and the free end.

[0053] Optionally, in the valve replacement device as described above, when there are multiple stabilizing plates, the multiple stabilizing plates are evenly distributed.

[0054] Optionally, in the valve replacement device as described above, when there are multiple stabilizing plates, the distance between adjacent stabilizing plates becomes smaller and smaller from the bending portion to the free end.

[0055] Optionally, in the valve replacement device as described above, the curved portion is provided with a curved block, and the width of the curved block is greater than the rod width of the curved rod.

[0056] Optionally, in the valve replacement device as described above, the outer frame further comprises:

[0057] A plurality of curved connecting rods are evenly connected to the inflow end of the outer frame body along the circumferential direction to form a variable diameter annular structure that first increases and then decreases from the outflow end to the inflow end.

[0058] Optionally, in the valve replacement device as described above, the inflow end of the outer frame body is expanded outward and smoothly connected to the outflow end of the curved connecting rod.

[0059] Optionally, in the valve replacement device as described above, the inflow end of the curved connecting rod is a blunt head formed by an arc surface.

[0060] Optionally, in the valve replacement device as described above, the inflow end of the curved connecting rod is provided with a protective blunt tip, which may be circular, elliptical, or have an arc surface at the distal end and the diameter of the arc surface is greater than the width of the curved connecting rod.

[0061] Optionally, in the valve replacement device as described above, the coating mechanism further comprises an outer frame coating, and the outer frame coating is coated on the outer frame;

[0062] The blunt tip or the protective blunt tip is provided with a blunt tip through hole, and the inflow end of the external frame is connected to the external frame covering through the blunt tip through hole via an external frame suture line.

[0063] Optionally, in the valve replacement device as described above, a marker is embedded in the blunt through hole, and the marker is made of a radiopaque material.

[0064] Optionally, in the valve replacement device as described above, the blunt-tip through hole is an elongated through hole or a waist-shaped hole.

[0065] The positive and progressive effects of the present invention are:

[0066] 1. The outflow end of the artificial valve leaflet is connected to the inner frame through the valve leaflet connecting structure. Since the ear has a multi-layer structure, when the valve leaflet connecting structure is connected to the inner frame through sutures, the sutures act on the ear parts of the outer and inner layers, and the inner frame will not contact the ear of the middle connecting layer, that is, the connecting layer only needs to withstand the tearing force from the artificial valve leaflet, and the connection layer is fixed mainly by the friction force formed by the squeezing of the ear parts of the outer and inner layers, and no external force such as tearing of sutures is required, thereby increasing the service life of the artificial valve leaflet.

[0067] 2. When the connecting piece is used, the two ends are clamped by the connecting ears of two adjacent artificial valve leaflets to achieve a better connection between the adjacent artificial valve leaflets. The connecting piece made of polymer material has a strong tear resistance and is used to withstand the tearing force during the opening and closing of adjacent artificial valve leaflets. The design of the median piece is used to play a positioning role, so that the connecting piece is evenly distributed in the adjacent connecting ears, thereby forming a connecting ear with uniform mechanical properties.

[0068] 3. The multi-layer structure of the connecting ear is formed by folding the integrally connected ear and the folded ear, and the ear is directly connected to the artificial valve leaflet, which greatly simplifies the production process of the connecting ear. It only needs to make the connecting ear together when making the artificial valve leaflet. And there is no need to suture the integrally connected parts, which further reduces the wear of the suture caused by the tearing force of the artificial valve leaflet.

[0069] 4. The design of the clip ear: after the joint ear is folded, the clip ear is clamped on the side of the artificial valve leaflet, which is conducive to better closure of the two ends of the outflow end of the adjacent artificial valve leaflet. The clip ear with gradual width can reduce the impact of the clip ear on the opening and closing of the artificial valve leaflet.

[0070] 5. By setting a connecting rod at the inflow end of the inner frame, the connecting rod is connected to the far end of the external delivery system. After the inflow end of the external frame is released, the inflow end of the external frame fits against the inner wall of the heart. If it is found that the inflow end of the external frame does not fit the inner wall of the heart perfectly, the delivery system can be adjusted to move the connecting rod, thereby adjusting the angle or position of the entire stent mechanism, thereby achieving the purpose of controllable and adjustable stent mechanism after the inflow end of the external frame is released and expanded.

[0071] 6. A connector is provided at the inflow end of the connecting rod to achieve better connection or separation with the conveying system.

[0072] Through the design of the connector through-hole, it can be achieved by pulling a wire through the connector through-hole, so that the inner frame can be more securely connected to the external conveying system, and when the inner frame is released, it can restrain the inner frame and make the release of the inner frame slower.

[0073] 7. The barbs can adopt two different structures. In the barb structure formed by two barbed rods, there is no fixed point in the middle part where the two barbed rods are connected. Therefore, when the barbs are compressed, the barbed rods will be easily deformed because there are not too many fixed constraint points. If the barbed rods are too long, the barbed rods may interfere with the external connection block in a compressed state, and the barbs may be sleeved on the external connection block and cannot expand and open. By ensuring that the outflow end of the barbs in a compressed state does not exceed the outflow end of the external connection block, even if the barbed rods are deformed, they cannot be sleeved on the external connection block. When the barbs adopt an independent curved rod structure, compared with the design of two barbed rods, the problem of excessive interference of the barbs during compression is avoided during transportation. In a compressed state, regardless of whether the outflow end of the curved rod exceeds the outflow end of the external connection block, the curved rod will not be sleeved on the external connection block.

[0074] 8. In order to increase the contact area between the curved rod and the native leaflet, the rod width from the curved part to the free end of the curved rod is greater than the rod width from the curved part to the connecting end, thereby increasing the contact area between the curved part and the free end and the native leaflet, thereby further increasing the stability of the barbs clamping the native leaflet. In order to reduce the weight of the curved rod, the curved rod can also be designed to have an equal rod width. In this case, a stabilizing plate is required to be provided on the curved rod between the curved part and the free end, thereby increasing the contact area between the curved part and the free end and the native leaflet, thereby increasing stability. When there are multiple stabilizing plates, a non-uniform distribution design is adopted, that is, the spacing between adjacent stabilizing plates in the direction from the curved part to the free end is getting smaller and smaller. This is because when the curved rod clamps the native leaflet, since the free end is farthest from the curved part, its clamping force is relatively small relative to the part close to the curved part. Therefore, a stabilizing plate with a relatively large density is provided at the free end, which can increase the combination area between the free end and the native leaflet, thereby increasing the stability of the curved rod clamping the native leaflet. At the same time, the small number density of stabilizing plates in the curved part is also conducive to reducing the contact area between the curved part and the native leaflet. Since the native leaflet is relatively soft, it is conducive to the curved part to sink into the native leaflet to a certain extent (that is, the native leaflet is sunken and deformed), thereby promoting the free end to fit the native leaflet better. On the contrary, if the native leaflet at the curved part is particularly thick and there are too many stabilizing plates, the curved part cannot sink into the native leaflet due to the large contact area, which may cause the free end to tilt, so that the free end cannot play the function of clamping the native leaflet. In order to increase the bending force of the bending rod, a bending block is added to the curved part, so that after the curved part is bent, the curved part can provide a greater bending retention force, which is conducive to the bending rod clamping the native leaflet.

[0075] 5. The inflow end of the external frame is provided with a plurality of curved connecting rods instead of the traditional grid shape as the outward expansion skirt part. Whether the curved connecting rod is compressed and straightened or in a bent state after expansion, the length of the proximal and distal ends of the curved connecting rod will not change. Therefore, the film will not be torn during the compression and expansion process, and the smooth compression of the inflow end of the external frame is achieved. The curved connecting rod is more flexible than the outward expansion skirt in the grid shape, and has a certain activity space in the circumferential direction, so the curved connecting rod can better adapt to the shape of the inner wall of the heart.

[0076] 6. Setting the inflow end of the curved connecting rod to a blunt tip can prevent the inner wall of the heart from being stabbed. In particular, a larger protective blunt tip is added to the inflow end of the curved connecting rod, so that the inflow end of the curved connecting rod forms a larger end, further preventing it from stabbing the heart. Through the design of the blunt through hole, the connection between the outer frame coating and the inflow end of the outer frame can be achieved by passing sutures through the blunt through hole, preventing the outer frame coating from sliding along the curved connecting rod, and ensuring that the positions of the outer frame coating and the inflow end of the outer frame remain stable during the implantation of the stent mechanism. A marker is embedded in the blunt through hole so that the inflow end of the external frame can have an obvious image point under the imaging device, which is convenient for the operator to confirm whether the position of the inflow end of the external frame meets the position requirements. BRIEF DESCRIPTION OF THE DRAWINGS

[0077] The disclosure of the present invention will become more apparent with reference to the accompanying drawings. It should be understood that these drawings are only for illustrative purposes and are not intended to limit the scope of protection of the present invention. In the drawings:

[0078] Figure 1(a) to Figure 1(e) A schematic diagram of a connection relationship between the connecting ear and the artificial valve leaflet in each embodiment of the present invention;

[0079] Figure 2 A diagram showing the position relationship between the ear portion in FIG1(c) and the artificial valve leaflet after being bent;

[0080] Figure 3 A positional relationship diagram of the ear portion and the folded ear formed by bending the connected ear and the artificial valve leaflet in FIG. 1( c );

[0081] Figure 4 A schematic diagram of the structure of the connecting piece of the present invention;

[0082] Figure 5 for Figure 3 A diagram showing the positional relationship between the lugs, artificial valve leaflets and the connecting piece;

[0083] Figure 6(a) shows Figure 5 A positional relationship diagram between two adjacent coupling ears, two adjacent artificial valve leaflets, and the coupling piece;

[0084] FIG6( b ) is a schematic diagram of FIG6( a ) from another angle;

[0085] Figure 7 1(d) is a diagram showing the positional relationship between the ear and the folded ear formed by bending the connected ear and the artificial valve leaflet;

[0086] Figure 8 1(e) is a diagram showing the positional relationship between the ear and the folded ear formed by bending the connected ear and the artificial valve leaflet;

[0087] Fig. 9 A schematic diagram of an application of the present invention;

[0088] FIG10( a ) is a schematic diagram of a structure of an embodiment of the present invention;

[0089] FIG10( b ) is a three-dimensional view of FIG10( a ) excluding the laminating mechanism;

[0090] FIG10( c ) is a front view of FIG10( b );

[0091] FIG10( d ) is a top view of FIG10( b );

[0092] FIG. 11( a ) is a front view of the outer frame in FIG. 10( a );

[0093] FIG11( b ) is a schematic diagram of the compressed state of FIG11( a );

[0094] FIG11( c ) is a partial enlarged view of FIG11( b );

[0095] FIG. 12( a ) is a front view of the inner frame in FIG. 10( a );

[0096] FIG12( b ) is a stereogram of FIG12( a );

[0097] FIG12( c ) is a schematic diagram of the compressed state of FIG12( a );

[0098] FIG12( d ) is a schematic diagram of an inner frame in a compressed state according to an embodiment of the present invention;

[0099] FIG12( e ) is a partial enlarged view of FIG12( d );

[0100] 13(a) and 13(b) are diagrams showing two different positional relationships between the bending rod and the external connection block when the external frame of the present invention is in a compressed state;

[0101] FIG. 13( c ) is a position distribution diagram of the stabilizing plate on the curved rod according to the present invention;

[0102] FIG13( d ) is a partial enlarged view of FIG13( c );

[0103] FIG13( e ) is a position relationship diagram of the bending portion and the bending block of the present invention;

[0104] FIG13( f ) is a partial enlarged view of FIG13( e );

[0105] FIG13( g ) is a perspective view of the outer frame in FIG13( a ) in an expanded state;

[0106] FIG. 14( a ) is a diagram of an implantation process of FIG. 10( a );

[0107] Figures 14(b) and 14(c) are diagrams showing another implantation process of Figure 10(a). DETAILED DESCRIPTION

[0108] The following describes the embodiments of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention.

[0109] It should be noted that the following embodiments and features therein may be combined with each other if there is no conflict.

[0110] In the description of the present invention, it should be noted that directional words such as the terms "outside", "middle", "inside", "outside", etc., which indicate directions and positional relationships, are based on the directions or positional relationships shown in the drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and cannot be understood as limiting the specific protection scope of the present invention.

[0111] In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features. Therefore, the definition of "first" and "second" features can explicitly or implicitly include one or more of the features. In the description of the present invention, "several" and "a number" mean two or more, unless otherwise clearly and specifically defined.

[0112] In this application, when describing artificial valve leaflets or abutments, "inflow end" and "outflow end" are used as directional terms, which are commonly used terms in the field of interventional medical devices, where "inflow end" refers to the end where antegrade blood first flows into the interventional medical device, such as the lower end in Figure 1(a). "Outflow end" refers to the end where antegrade blood flows out of the interventional medical device, such as the upper end in Figure 1(a). "Axial" refers to the direction parallel to the line connecting the center of the "inflow end" and the center of the "outflow end", such as Fig. 9The axial direction of the middle bracket is also the up-and-down direction, and the “radial direction” refers to the direction perpendicular to the above-mentioned “axial direction”.

[0113] In this application, when describing an artificial valve leaflet or a joint ear, such as Fig. 9 As shown, the “proximal side” refers to the side of the artificial valve leaflet that is close to the stent axis A after being installed on the stent, and correspondingly, the “distal side” refers to the side of the artificial valve leaflet that is away from the stent axis A after being installed on the stent.

[0114] In this application, when describing the inner frame or the outer frame, "inflow end" and "outflow end" are used as directional words, which are commonly used terms in the field of interventional medical devices, where "inflow end" refers to the end where antegrade blood first flows into the interventional medical device, such as the upper end in Figure 10(a). "Outflow end" refers to the end where antegrade blood flows out of the interventional medical device, such as the lower end in Figure 10(a).

[0115] The embodiment of the present invention provides a replacement valve device, which includes a stent mechanism and a leaflet mechanism, wherein the stent mechanism has an outer frame 100 and an inner frame 200, wherein the inner frame 200 is usually disposed inside the outer frame 100 and connected to the outer frame 100. The leaflet mechanism is located inside the inner frame 200, and a function similar to a "one-way valve" is formed by the leaflet mechanism, which can well avoid reflux.

[0116] The valve leaflet mechanism includes a plurality of artificial valve leaflets 500 and a plurality of valve leaflet connection structures 600, Fig. 9 The leaflet connection structure 600 is used to connect to the outflow end of the artificial leaflet 500, and the artificial leaflet 500 is connected to the inner frame 200 through the leaflet connection structure 600, that is, the artificial leaflet 500 is not directly connected to the inner frame 200, but is indirectly connected through the leaflet connection structure 600.

[0117] The leaflet connection structure 600 of the present invention includes a connection ear 610 connected to the artificial leaflet 500, and each artificial leaflet 500 is connected to a connection ear 610 on both sides of the outflow end. The connection ear 610 is bent at the side of the outflow end of the artificial leaflet 500. The connection ear 610 has at least three layers, and the at least three layers are respectively an outer layer located on the far axis side, an inner layer located on the near axis side, and a plurality of intermediate layers located between the outer layer and the inner layer. One of the plurality of intermediate layers is connected to the artificial leaflet 500 as a connection layer. For example, Figure 3 As shown, the ear 610 has a four-layer structure, and the middle layer located on the distal axis side of the two middle layers is connected to the artificial valve leaflet 500 as a connecting layer.

[0118] In the present invention, since the connecting ear 610 has a multi-layer structure, when the connecting ear 610 is connected to the inner frame 200 by sutures, the sutures act on the connecting ear parts of the outer layer and the inner layer, and the inner frame 200 will not contact the connecting ear of the middle connecting layer, that is, the connecting layer only needs to withstand the tearing force from the artificial valve leaflet 500, and the connection layer is fixed mainly by the friction force formed by the squeezing of the connecting ear parts of the outer layer and the inner layer, and no external force such as tearing of sutures is required, thereby increasing the service life of the artificial valve leaflet.

[0119] In some embodiments, reference Figure 4 and Figure 5 The leaflet connection structure 600 further includes a connection piece 620, one end of which is disposed between the outer layer and the connection layer of the connection ear 610, and the connection piece 620 is clamped by the connection ear 610 to connect two adjacent artificial leaflets 500. Several artificial leaflets 500 are sequentially connected through the leaflet connection structure 600 to form a one-way openable and closable structure in the middle.

[0120] In specific implementation, as shown in Fig. 6(a) and Fig. 6(b), the two ends of the connecting piece 620 are respectively arranged between the outer layer and the connecting layer of two adjacent connecting ears 610, and the two adjacent connecting ears 610 are respectively connected to the two adjacent artificial valve leaflets 500, so that the two adjacent artificial valve leaflets 500 are connected through the connecting ears 610 and the connecting piece 620. At this time, a connecting piece 620 is respectively arranged on both sides of the outflow end of an artificial valve leaflet 500, and the outflow end sides of two adjacent artificial valve leaflets 500 share a connecting piece 620, so that a plurality of artificial valve leaflets 500 are connected in sequence through the connecting ears 610 and the connecting piece 620.

[0121] In some embodiments, the connecting piece 620 is made of a polymer material, such as PET, etc. The connecting piece 620 made of a polymer material has a strong tear resistance and is used to withstand the tearing force during the opening and closing of adjacent artificial valve leaflets 500.

[0122] In some embodiments, reference Figure 4 The connecting piece 620 is provided with a middle piece 621, which is located at the middle outflow end side of the connecting piece 620. The design of the middle piece 621 is used to play a positioning role, so that the connecting pieces 620 are evenly distributed in the adjacent connecting ears 610, thereby forming connecting ears with uniform mechanical properties.

[0123] In some embodiments, the median piece 621 is integrally connected to the connecting piece 620 .

[0124] In some embodiments, at least three layers of the ear 610 are sutured together to achieve shaping. The sutures may be thinner than the sutures used when connecting the ear 610 to the stent.

[0125] When the leaflet connection structure 600 has a connecting piece 620, at least three layers of the connecting ear 610 and the connecting piece 620 are sutured together by sutures to achieve shaping.

[0126] In some embodiments, the multi-layer structure of the connector 610 may be an independent multi-layer structure, preferably a multi-layer structure formed by unfolding a one-piece connector and then bending it, so as to greatly simplify the manufacturing process of the connector 610. Specifically:

[0127] 1( a ), the ear 610 includes an ear portion 611 and a folded ear 612 , one end of the ear portion 611 is connected to the artificial valve leaflet 500 , and the inflow end of the folded ear 612 is connected to the outflow end of the other end of the ear portion 611 .

[0128] In the expanded state, as shown in Figure 1(a), the side close to the artificial valve leaflet 500 is the inner side, and the side away from the artificial valve leaflet 500 is the outer side, the inner side of the ear 611 is connected to the outer side of the outflow end of the artificial valve leaflet 500, and the inflow end of the folded ear 612 is connected to the outflow end of the outer side of the ear 611, and the two connecting ears 610 form two opposite L-shaped structures on both sides of the outflow end of the artificial valve leaflet 500.

[0129] Furthermore, after the ear 611 is folded 180° from the circumferential middle to the distal axis, the folded ear 612 is bent 180° from the connection position with the ear 611 to the proximal axis to form the connecting ear 610, and the connecting ear 610 at this time is a three-layer structure.

[0130] When the leaflet connection structure 600 has the connecting piece 620 , the connecting piece 620 is clamped between the folded ears 611 .

[0131] In some embodiments, one end of the ear 611 is integrally connected to the artificial valve leaflet 500, and the inflow end of the folded ear 612 is integrally connected to the outflow end of the other end of the ear 611. The artificial valve leaflet 500 and the connecting ear 610 are integrally designed, and the connecting ear 610 only needs to be made together when making the artificial valve leaflet 500. And there is no need to suture between the integrally connected artificial valve leaflet 500 and the ear 611, and between the ear 611 and the folded ear 612, which further reduces the wear of the suture caused by the tearing force of the artificial valve leaflet 500.

[0132] In some embodiments, referring to FIG. 1( c ), the folded ear 612 includes an inner folded ear 6121 and an outer folded ear 6122. In the unfolded state, the side close to the artificial valve leaflet 500 is the inner side, and the side away from the artificial valve leaflet 500 is the outer side. The inner folded ear 6121 is located on the inner side of the outer folded ear 6122. When the ear 611 is folded 180° from the circumferential middle to the distal axis, as shown in FIG. Figure 2As shown, the inner folded ear 6121 and the outer folded ear 6122 are stacked together, and the inner folded ear 6121 and the outer folded ear 6122 are bent 180° from the connection position with the ear portion 611 to the proximal side to form a connecting ear 610. Figure 3 As shown, the connecting ear 610 at this time is a four-layer structure, wherein a two-layer structure is formed on the proximal side of the ear portion 611 by the inner folded ear 6121 and the outer folded ear 6122 .

[0133] When the artificial valve leaflet 500 is closed, the artificial valve leaflet 500 needs to withstand the pressure of the blood. At this time, the ear 611 will be subjected to a tearing force toward the proximal side. At this time, the tension of the suture thread mainly acts on the proximal side of the ear 611, and the folded ear 612 with a two-layer structure can better withstand the tension.

[0134] 1(c), an avoidance groove 6123 is provided between the inner folding ear 6121 and the outer folding ear 6122. The avoidance groove 6123 can reduce the internal stress formed by the reverse folding of the connecting ear 610, or prevent the connecting ear 610 material from accumulating at the folding position and causing the connecting ear 610 to be folded and deformed.

[0135] In some embodiments, referring to FIG. 1( c ) and Figure 2 , the length of the outer folded ear 6122 is greater than the length of the inner folded ear 6121. When the inner folded ear 6121 and the outer folded ear 6122 are stacked together, referring to Figures 6(a) and 6(b), the ends of the inner folded ear 6121 and the outer folded ear 6122 are flush.

[0136] Since the outer folded ear 6122 is wrapped around the outer side of the inner folded ear 6121, when the length of the outer folded ear 6122 is greater than the length of the inner folded ear 6121, after the link ear 610 is folded, the inner folded ear 6121 and the outer folded ear 6122 ends can be flush. Here, the length of the outer folded ear 6122 can be greater than the length of the inner folded ear 6121 by 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, etc. The specific length can be determined according to the thickness of different artificial valve leaflets 500, and can be obtained without creative labor by ordinary technicians in this field.

[0137] 1 (b), the outer side of the folded ear 612 is provided with a clip ear 613, after the ear portion 611 and the folded ear 612 are folded to form a joint ear 610, Figure 7 The clip ears 613 are connected to the side of the artificial valve leaflet 500. The design of the clip ears 613 is conducive to better closing of the two ends of the outflow end of the adjacent artificial valve leaflet 500.

[0138] In some embodiments, when the clip ear 613 is connected to the artificial valve leaflet 500, the connection can be made through sutures.

[0139] In some embodiments, the clip ear 613 is integrally connected with the folding ear 612 .

[0140] In some embodiments, reference Figure 7 The width of the clip ears 613 located on the side of the artificial valve leaf 500 decreases from the outflow end to the inflow end of the artificial valve leaf 500. The clip ears 613 with gradually changing widths can reduce the influence of the clip ears 613 on the opening and closing of the artificial valve leaf 500.

[0141] In some embodiments, referring to FIG. 1( d ), when the folding ear 612 includes an inner folding ear 6121 and an outer folding ear 6122 , the clip ear 613 is disposed on the outer side of the outer folding ear 6122 . Figure 7 The clip ear 613 is connected to the side of the artificial valve leaflet 500.

[0142] In some embodiments, referring to FIG. 1( e ), when the folding ear 612 includes an inner folding ear 6121 and an outer folding ear 6122, the clip ear 613 is disposed on the inner side of the inner folding ear 6121. Figure 8 The clip ear 613 is connected to the side of the artificial valve leaflet 500.

[0143] In some embodiments, reference Figure 8 When the clip ear 613 is arranged on the inner side of the inner fold ear 6121, the clip ear 613 is connected to the outflow end of the artificial valve leaflet 500. Such a design increases the tear resistance of the connection between the artificial valve leaflet and the connecting ear, which forms a two-layer structure after folding.

[0144] In some embodiments, the connecting ears 610 with a multi-layer structure are respectively connected to the two sides of the outflow end of each artificial valve leaflet 500, and the two adjacent artificial valve leaflets 500 are connected by the connecting ears 610 and the connecting pieces 620. Before the leaflet connection structure 600 is connected to the inner frame 200, the connecting ears 610 and the connecting pieces 620 of the multi-layer structure are first connected together by sutures, so that multiple artificial valve leaflets 500 are also connected together. Then, the link ear 610 is sutured to the inner frame 200 by sutures. Here, the sutures used for the link ear 610 can be thinner than the sutures used to suture the link ear 610 to the inner frame 200. Since the space of the stent used to fix the link ear 610 is limited, relatively thick sutures are used to fix the link ear 610 and the inner frame 200. A more secure fixation of the link ear 610 can be achieved by suturing with a smaller number of suture needles. During suturing, the stent sutures penetrate the outer and inner layers of the link ear 100, so that the connection layer connected to the artificial valve leaflet 500 is protected between the outer and inner layers from the tearing force of the stent sutures.

[0145] In some embodiments, reference Figure 12(a) to Figure 12(c) The inner frame 200 includes an inner frame body 210 and a plurality of connecting rods 220. The inner frame body 210 is a hollow cylindrical structure composed of a plurality of layers of inner frame grids. A plurality of connecting rods 220 are evenly connected to the inflow end of the inner frame body 210 along the circumferential direction, and the connecting rods 220 are used to connect with the distal end of the external delivery system. By arranging the connecting rods 220 at the inflow end of the inner frame body 210, and connecting the connecting rods 220 with the distal end of the external delivery system, after the inflow end of the outer frame 100 is released, the inflow end of the outer frame 100 fits with the inner wall of the heart. At this time, if it is found that the inflow end of the outer frame 100 is not perfectly fitted with the inner wall of the heart, the angle or position of the entire stent mechanism can be adjusted by adjusting the delivery system and the movable connecting rods 220, thereby achieving the purpose of controllable and adjustable stent mechanism of the inflow end of the outer frame 100 after the release and expansion.

[0146] In some embodiments, the inflow ends of the plurality of connecting rods 220 are tiltedly disposed at the inflow end of the inner frame body 210, and the plurality of connecting rods 220 form a retracted structure that retracts from the outflow end to the inflow end, which facilitates connection with the conveyor.

[0147] In some embodiments, referring to FIG. 12( a ), a connector 221 is provided at the inflow end of the connecting rod 220 , and the connector 221 may be a card connector of a circular, elliptical or rectangular structure. The connector 221 is used to be card-connected with the conveying system to facilitate connection or separation with the conveying system.

[0148] In some embodiments, the valve replacement device further comprises a coating mechanism, wherein the coating mechanism comprises an inner frame coating, and the inner frame coating is coated on the inner frame 200 .

[0149] Referring to Figure 12(a), a connector through hole 222 is provided on the connector 221, and the inflow end of the inner frame 200 can pass through the connector through hole 222 by a pull wire, so that the inner frame can be more securely connected to the conveying system, and when the inner frame is released, it can play a role in restraining the inner frame, so that the release of the inner frame is slower.

[0150] In some embodiments, when the inner frame 200 is disposed in the outer frame 100, the inflow end of the inner frame 200 does not exceed the inflow end of the outer frame 100 in the axial direction. An inflow end of the inner frame 200 that is too high may cause the inflow end of the inner frame 200 to abut against the inner wall of the atrium, causing damage to the atrium. Especially during atrial contraction, an inflow end of the inner frame 200 that is too high may more strongly impact against the inner wall of the atrium.

[0151] In some embodiments, referring to FIG. 12( a ), the inner frame 200 further includes a plurality of inner connection blocks 230, which are uniformly connected to the outflow end of the inner frame body 210 along the circumferential direction. In this case, the inner frame 200 includes a plurality of connection rods 220, the inner frame body 210, and the inner connection blocks 230 connected in sequence from the inflow end to the outflow end. The inner frame 200 is connected to the outer frame 100 through the inner connection blocks 230. Preferably, the inner frame 200 is connected to the outer frame 100 by connecting the inner connection blocks 230 to the outer connection blocks 130.

[0152] In some embodiments, referring to FIG. 11( a) and FIG. 12( a), the outer connection block 130 and the inner connection block 230 are both outflow end folding structures that fold toward the outflow end. The folding angle of the outflow end folding structure is α, 45°≤α≤75°. If the folding angle is too large, the speed of endothelialization of the outflow end of the outer frame 100 or the outflow end of the inner frame 200 will be affected. Therefore, an appropriate folding angle can meet the endothelialization speed and protect the inner wall of the heart from being punctured by the collision of the distal end of the outer connection block 130 or the inner connection block 230.

[0153] In some embodiments, the outer diameter of the inner frame 200 is not greater than the inner diameter of the outer frame 100 at the same cross section, the outflow end of the inner frame 200 is connected to the outflow end of the outer frame 100, and at least the middle of the inner frame 200 to the inflow end is suspended inside the outer frame 100. In this way, except for the connection between the two, the rest of the inner frame 200 can be suspended inside the outer frame 100, and during the contraction and expansion of the heart, the influence on the shape of the inner frame is minimized, the deformation of the valve leaflet mechanism apposition site is avoided, and the regurgitation of the artificial heart valve is reduced.

[0154] In some embodiments, referring to FIG12(a), the inner frame body 210 is a hollow cylindrical structure composed of two layers of inner frame grids, and the outflow end of the inner frame body 210 is a folded structure. The grid shapes of the two layers of outer frame grids can be designed to be the same or different as needed, and the two layers of grids shown in FIG12(a) are designed to adopt different grid shapes.

[0155] In some embodiments, referring to FIG. 12( a ), each layer of the inner frame grid is connected by a connecting column 240, and two adjacent layers of polygonal frames are heat-set to form the inner frame body 210. The connecting column 240 where the inner frame grid layer closest to the outflow end is located is provided with a leaflet suture hole 241, and the inner frame 200 and the leaflet connection structure 600 are sutured and connected through the leaflet suture hole 241.

[0156] Specifically, the connecting ear 610 and the connecting piece 620 of the leaflet connecting structure 600 are both located on the inner side of the inner frame 200 , and are sutured to the inner frame via the leaflet suture holes 241 with suture threads.

[0157] The number of the leaflet suture holes 241 is at least 2 to meet the leaflet requirements of the replacement valve. The leaflet suture holes 241 are evenly distributed on the connecting column 240 along the circumferential direction. The leaflet suture holes 241 can also be provided on each connecting column 240.

[0158] In some embodiments, reference Figure 12(a) to Figure 12(c) The leaflet suture hole 241 is a long strip through hole or a waist-shaped hole.

[0159] In some embodiments, referring to FIG. 12( d ) and FIG. 12 ( e ), the leaflet suture hole 241 is composed of a plurality of suture sub-holes 2411 , and the plurality of suture sub-holes 2411 are distributed axially to form a group of leaflet suture holes 241 .

[0160] For example, as shown in FIG. 12( e ), two suture sub-holes 2411 are arranged side by side in the axial direction to form a group of leaflet suture holes 241. With such a design, as shown in FIG. 9 , the leaflet connection structure 600 can be well fitted on the inner side of the inner frame 200. In addition, the outer part of the suture connected to the leaflet connection structure 600 is wound around the connection column 240 between two adjacent suture sub-holes 2411, further avoiding the problem of the suture tearing or abrasion of the outer layer of the leaflet connection structure 600.

[0161] In some embodiments, the suture sub-hole 2411 is a long strip-shaped through hole or a waist-shaped hole.

[0162] In some embodiments, reference Figure 10(a) to Figure 10(d) The valve replacement device further includes a plurality of barbs 400 , which are uniformly arranged on the outer peripheral surface of the outer frame 100 along the circumferential direction, and a barb opening 410 facing the inflow end is formed between the barbs 400 and the outer frame 100 .

[0163] In some embodiments, referring to FIG. 11( a ), the barb 400 includes two barb rods 420 , one end of the two barb rods 420 first converges inwards from the outflow end to the inflow end and then expands outwards and then smoothly connects to form an inverted V-shaped structure with rounded corners, and the other ends of the two barb rods 420 are bent inwards toward the inflow end and are respectively connected to the outer peripheral surface of the external frame 100 , so as to form a barb opening 410 and the barb opening 410 has a smoothly transitioned shrinking structure and an outward expansion structure from the outflow end to the inflow end. The design of the two barb rods 420 allows the native valve leaflets to be stuck in the barb opening 410 between the barb 400 and the external frame 100 when the external frame 100 is released. After the external frame 100 is completely released, the barb 400 is squeezed by the external frame 100 and is close to the inner wall of the right ventricle. The barb 400 is anchored to reduce the damage to the tissue by the external frame 100 . When the right ventricle contracts, the resistance of the valve leaflet mechanism to the stent mechanism, as well as the friction between the stent mechanism and the right ventricle wall, can offset the upward thrust of the right ventricle pressure on the stent mechanism through the barbs 400. The constricted structure of the barbs 400 can increase the clamping force between the barbs 400 and the valve leaflets. The outward expansion structure of the barbs 400 increases the friction with the right ventricle wall, and the outward expansion end is arc-shaped to avoid puncturing the right ventricle wall.

[0164] In some embodiments, referring to FIG. 11( a ), the outer frame 100 includes an outer frame body 110 and a plurality of outer connection blocks 130 . The outer frame body 110 is a hollow cylindrical structure composed of a plurality of layers of outer frame grids. The plurality of outer connection blocks 130 are evenly connected to the outflow end of the outer frame body 110 along the circumferential direction. The outer frame 100 is connected to the inner frame 200 through the outer connection blocks 130 .

[0165] With reference to Figure 11 (b) and Figure 11 (c), the outflow end of barb 400 in compressed state does not exceed the outflow end of outer connecting block 130. The barb 400 needs to be straightened when replacing the valve device during transportation, as shown in Figure 11 (b) and Figure 11 (c), and the free end of barb 400 (i.e., away from the end connected with outer frame 100) flips 180 ° to form a relatively straight shape for compression. When the barb structure formed by two barb rods, the middle part connected by the two barb rods does not have a fixed point, so when the barb is compressed, the barb rod will be easily deformed because there are no too many fixed constraint points. If the barb rod is too long, the barb rod may interfere with the outer connecting block in compressed state, and the barb is sleeved on the outer connecting block, and cannot be expanded and opened. By the way that the outflow end of the barb in compressed state does not exceed the outflow end of the outer connecting block, even if the barb rod is deformed, it cannot be sleeved on the outer connecting block.

[0166] In some embodiments, referring to FIG. 11( a ), the outer frame 100 further includes a plurality of curved connecting rods 120, which are evenly connected to the inflow end of the outer frame body 110 along the circumferential direction, and the plurality of curved connecting rods 120 form a variable diameter annular structure that increases first and then decreases from the outflow end to the inflow end. At this time, the outer frame 100 includes a plurality of curved connecting rods 120, the outer frame body 110, and the outer connection block 130 that are sequentially connected from the inflow end to the outflow end.

[0167] The inflow end of the traditional external frame 100 usually directly adopts the external frame grid of the external frame body 110 to expand outward to form an outward expansion skirt. Since the axial length of the compressed external frame grid can become very long, it will seriously tear the external frame coating 300. Therefore, the present invention abandons the above-mentioned structure and adopts a plurality of curved connecting rods 120 to replace the traditional outward expansion skirt. Whether the curved connecting rod 120 is compressed and straightened or in a bent state after expansion, it will not change the length of the proximal and distal ends of the curved connecting rod 120. Therefore, the coating will not be torn during the compression and expansion process, and the smooth compression of the inflow end of the external frame is achieved. The curved connecting rod 120 is more flexible than the outward expansion skirt in the shape of a grid, and has a certain activity space in the circumferential direction, so the curved connecting rod 120 can better adapt to the shape of the inner wall of the heart.

[0168] In some embodiments, the inflow end of the outer frame body 110 is expanded outward and smoothly connected to the outflow end of the curved connecting rod 120. This allows the outer frame 100 to quickly expand to a target size after being released. This also avoids the risk of the outer frame body 110 and the curved connecting rod 120 being broken when the outer frame 100 is compressed.

[0169] In some embodiments, the inflow end of the curved connecting rod 120 is a blunt head formed by an arc surface to prevent puncturing the inner wall of the heart.

[0170] In some embodiments, referring to FIG. 11( a ), a protective blunt tip 121 is provided at the inflow end of the curved connecting rod 120. The protective blunt tip 121 may be circular, elliptical, or have an arc surface at the distal end, and the diameter of the arc surface is greater than the width of the curved connecting rod 120. A larger protective blunt tip 121 is provided at the inflow end of the curved connecting rod 120, so that the inflow end of the curved connecting rod 120 forms a larger tip, further preventing it from stabbing the heart.

[0171] In some embodiments, the coating mechanism further includes an outer frame coating 300 , and the outer frame coating 300 is coated on the outer frame 100 .

[0172] 11(a), a blunt through hole 122 is provided on the blunt tip or protective blunt tip 121, and the inflow end of the external frame 100 is connected to the external frame coating 300 by passing a suture through the blunt through hole 122. Through the design of the blunt through hole, the connection between the external frame coating and the inflow end of the external frame can be achieved by passing a suture through the blunt through hole, preventing the external frame coating from sliding along the curved connecting rod, and ensuring that the positions of the external frame coating and the inflow end of the external frame remain stable during the implantation of the stent mechanism.

[0173] In some embodiments, a marker is embedded in the blunt through hole 122, and the marker is made of a radiopaque material. The marker is embedded in the blunt through hole 122, so that the inflow end of the external frame 100 can have a clear image point under the imaging device, which is convenient for the operator to confirm whether the position of the inflow end of the external frame 100 meets the position requirements.

[0174] In some embodiments, the blunt through hole 122 is a long strip through hole or a waist-shaped hole. The design of the long strip through hole or waist-shaped hole does not affect the passage of the suture after the marker is embedded. The marker can be embedded on the inner wall of the blunt through hole 122 before or after the suture passes through.

[0175] In some embodiments, referring to FIG. 11( a ), the outer frame body 110 is a hollow cylindrical structure composed of three layers of outer frame grids, and the inflow end of the outer frame body 110 is an outward expansion structure and the outflow end is a retracted structure. The grid shapes of the three layers of outer frame grids can be designed to be the same or different as needed, and the three layers of grids shown in FIG. 11( a ) are different grid shapes. When the outer frame body 110 is designed with barbs 400, the barbs 400 are located on a layer of outer frame grids near the outflow end. Preferably, they are located on the side of the inflow end of the retracted structure.

[0176] Reference Figure 13(a) to Figure 13(f) The present invention provides a valve replacement device, Figure 10(a) to Figure 10(d) Compared with the embodiment of the present invention, the structure of the barb 400 used is different, and the remaining structures are the same.

[0177] In some embodiments, the barb 400 adopts a curved rod 430, and the curved rod 430 includes a connecting end 431, a curved portion 432 and a free end 433. The connecting end 431 is connected to the outer frame 100, and the curved portion 432 and the free end 433 form a barb opening 410. When the barb 400 adopts an independent curved rod 430 structure, compared with the design of using two barbed rods 420, it avoids the problem of barb transition interference during compression during transportation. In the compressed state, as shown in Figure 13 (a), the outflow end of the curved rod 430 does not exceed the outflow end of the outer connecting block 130, and as shown in Figure 13 (b), the outflow end of the curved rod 430 exceeds the outflow end of the outer connecting block 130. Regardless of whether the outflow end of the curved rod 430 exceeds the outflow end of the outer connecting block 130, the phenomenon of the curved rod 430 being sleeved on the outer connecting block 130 will not occur.

[0178] In some embodiments, the rod width from the curved portion 432 to the free end 433 is greater than the rod width from the curved portion 432 to the connecting end 431. In order to increase the contact area between the curved rod 430 and the native leaflet, the rod width from the curved portion 432 to the free end 433 of the curved rod 430 is greater than the rod width from the curved portion 432 to the connecting end 431, thereby increasing the contact area between the curved portion 432 and the free end 433 and the native leaflet, thereby further increasing the stability of the barb 400 in clamping the native leaflet.

[0179] In some embodiments, referring to Fig. 13(c) and Fig. 13(d), the rod width from the curved portion 432 to the free end 433 is equal to the rod width from the curved portion 432 to the connecting end 431, and a stabilizing plate 434 is provided on the curved rod 430 between the curved portion 432 and the free end 433, and the width of the stabilizing plate 434 is greater than the rod width of the curved rod 430. In order to reduce the weight of the curved rod 430, the curved rod 430 can also be designed to have equal rod widths. In this case, a stabilizing plate 434 is required to be provided on the curved rod 430 between the curved portion 432 and the free end 433, thereby increasing the contact area between the curved portion 432 and the free end 433 and the native leaflet, thereby increasing stability.

[0180] In some embodiments, the shape of the stabilizing plate 434 can be rectangular, semicircular, circular, crescent-shaped, etc. As shown in FIG13( d ), the stabilizing plate 434 is crescent-shaped.

[0181] In some embodiments, there are one or more stabilizing plates 434 , and the stabilizing plates 434 are disposed at any position between the bent portion 432 and the free end 433 .

[0182] In some embodiments, when there is one stabilizing plate 434, one stabilizing plate 434 is located at the end of the free end 433 or between the bent portion 432 and the free end 433. As shown in FIG. 13(a) and FIG. 13(b), the stabilizing plate 434 is located at the end of the free end 433.

[0183] In some embodiments, when there are multiple stabilizing plates 434, the multiple stabilizing plates 434 are evenly distributed. Preferably, as shown in FIG. 13( c ) and FIG. 13( d ), when there are multiple stabilizing plates 434, the spacing between adjacent stabilizing plates 434 decreases from the curved portion 432 to the free end 433 .

[0184] When there are multiple stabilizing plates 434, a non-uniform distribution design is adopted, that is, the distance between adjacent stabilizing plates 434 in the direction from the bending portion 432 to the free end 433 becomes smaller and smaller. This is because when the bending rod 430 clamps the native leaflet, since the free end 433 is farthest from the bending portion 432, its clamping force is relatively small relative to the part close to the bending portion 432. Therefore, a relatively high density of stabilizing plates 434 is provided at the free end 433 to increase the combined area between the free end 433 and the native leaflet, thereby increasing the stability of the bending rod 430 in clamping the native leaflet. At the same time, the small density of the stabilizing plates 434 in the curved portion 432 is also conducive to reducing the contact area between the curved portion 432 and the native leaflet. Since the native leaflet is relatively soft, it is conducive to the curved portion 432 to sink into the native leaflet to a certain extent (that is, the native leaflet is concave and deformed), thereby promoting the free end 433 to fit the native leaflet better. On the contrary, if the native leaflet at the curved portion 432 is particularly thick and there are too many stabilizing plates 434, the curved portion 432 cannot sink into the native leaflet due to the large contact area, which may cause the free end 433 to tilt up, and the free end 433 cannot play the function of clamping the native leaflet.

[0185] In some embodiments, referring to Fig. 13(e) and Fig. 13(f), the curved portion 432 is provided with a curved block 435, and the width of the curved block 435 is greater than the width of the curved rod 430. In order to increase the bending force of the curved rod 430, the curved block 435 is added to the curved portion 432, so that after the curved portion 432 is bent, the curved portion 432 can provide a greater bending retention force, which is beneficial for the curved rod 430 to clamp the native valve leaflet.

[0186] The present invention Figure 10(a) to Figure 10(d) The valve replacement device provided by the embodiment of the present invention, Figure 13(a) to Figure 13(f) The valve replacement devices provided in the embodiments can be implanted into the human body via the femoral vein or the jugular vein. Figure 10(a) to Figure 10(d) Taking the replacement valve device provided in the embodiment as an example, the implantation method is as follows:

[0187] After placing the replacement valve device at the predetermined position, the outer tube 910 of the delivery system is first retreated to release the outflow end of the outer frame 100. At this time, the barbs 400 are turned outward to capture the native leaflets. After completing the capture of the native leaflets, the outer tube 910 continues to retreat to release the inflow end of the outer frame 100. At this time, the inflow end of the outer frame 100 is completely released and fits against the inner wall of the heart. At this time, observe whether the fitting position of the outer frame 100 and the inner wall of the heart is appropriate. If not, the connecting rod 220 of the inner frame 200 is still in a connected state, that is, the connecting rod 220 is placed in the groove of the connector of the delivery system and is covered by the ear-hanging covering tube of the delivery system. At this time, the inner frame 200 is controlled by the connecting rod 220, thereby driving the adjustment of the movement of the outer frame 100, as shown in Figure 14 (a). When it is confirmed that the position of the outer frame 100 meets the requirements, the ear-hanging covering tube is retracted so that the connecting rod 220 is not constrained by the ear-hanging covering tube and pops out from the groove of the connector. The delivery system is separated from the connecting rod 220 of the inner frame 200, so that the replacement valve device is stably present in the heart.

[0188] The present invention Figure 10(a) to Figure 10(d) The valve replacement device provided by the embodiment of the present invention, Figure 13(a) to Figure 13(f) The valve replacement devices provided in the embodiments can be implanted into the human body via the apical approach. Figure 10(a) to Figure 10(d) Taking the replacement valve device provided in the embodiment as an example, the implantation method is as follows:

[0189] The inner tube 920 of the conveying system penetrates the inside of the stent mechanism. The inner tube 920 is used to collect the inflow end of the stent mechanism at the far end, and can be connected or separated from the connecting rod 220 of the inner frame 200. The outflow end of the stent mechanism is collected at the far end of the outer tube 910. When releasing the stent mechanism, as shown in FIG14(b), first, the outflow end of the stent mechanism is released by retreating the outer tube 910. At this time, the barbs 400 are turned outward to capture the native leaflets. After completing the capture of the native leaflets, as shown in FIG14(c), the inflow end of the outer frame 100 is released through the distal end of the inner tube 920. The inflow end of the outer frame 100 is completely released and fits against the inner wall of the heart. At this time, observe whether the fitting position of the outer frame 100 and the inner wall of the heart is appropriate. If not, since the distal end of the inner tube 920 is still connected to the connecting rod 220, the inner frame 200 is controlled by the connecting rod 220, thereby driving the adjustment of the movement of the outer frame 100. When it is confirmed that the position of the outer frame 100 meets the requirements, the connection between the distal end of the inner tube 920 and the connecting rod 220 is released, so that the replacement valve device is stably present in the heart.

[0190] The embodiment of the present invention provides a valve replacement device, Figure 10(a) to Figure 10(d) Compared with the embodiment, a wire pulling hole is provided on the end of the barb 400 away from the outer frame 100, and the rest of the structures are the same.

[0191] In some embodiments, the barb 400 includes two barb rods 420, and the corner formed by the smooth connection of the two barb rods 420 is an end away from the outer frame 100. The corner is provided with a pull wire hole as a free end, and the pull wire hole allows a control pull wire to pass through, thereby controlling the angle of the barb opening 410.

[0192] By controlling the pull line to open the barb 400 to a large angle and maintain it for a long time, the barb 400 can have more opportunities to capture the native leaflets. Even if the barb 400 fails to capture, the barb 400 can be opened again using the control pull line to recapture the native leaflets. Each barb 400 of the present embodiment can be independently controlled by its independent control pull line to open and close the barb 400, and can be opened at different angles at different times and maintained for different times. Therefore, the differences in the three leaflets of the native leaflets are effectively addressed. The resulting differences in the required opening angles or times of the barbs 400 facilitate the replacement valve device to capture all native leaflets, or facilitate all barbs 400 to capture native leaflets, thereby increasing the stability of the replacement valve device in the human body. At the same time, for the operator, the fault tolerance of the replacement valve device in capturing the native leaflets is improved, and multiple repeated captures of the native leaflets can be achieved. Different barb 400 adjustments can be made actively according to the changes in the native leaflets, instead of having to wait for the native leaflets to move to the desired position before capturing. This greatly reduces the difficulty of the replacement surgery, reduces the operation time, and thus reduces the harm of the surgery to the human body.

[0193] The embodiment of the present invention provides a valve replacement device, Figure 13(a) to Figure 13(f) Compared with the embodiment, a wire pulling hole is provided at the end of the free end 433 of the bending rod 430, and the rest of the structures are the same.

[0194] The present invention is described in detail above in conjunction with the embodiments of the accompanying drawings. A person skilled in the art can make various variations of the present invention according to the above description. Therefore, some details in the embodiments should not be construed as limiting the present invention, and the present invention shall be protected by the scope defined by the attached claims.

Claims

1. A valve replacement device, comprising: A support mechanism, the support mechanism comprising an outer frame and an inner frame connected to the outer frame; a valve leaflet mechanism, the valve leaflet mechanism is located in the inner frame, and the valve leaflet mechanism includes a plurality of artificial valve leaflets; Characterized in that the leaflet mechanism further comprises: A plurality of leaflet connection structures, each of which has a connection ear and a connection piece, wherein each of the outflow ends of the artificial leaflets is respectively connected to a connection ear, the connection ear has at least three layers of structure connected as one body, an intermediate layer in the connection ear is connected to the artificial leaflets as a connection layer, and the two ends of the connection piece are respectively arranged in the connection ear connecting two adjacent artificial leaflets, and the connection piece is clamped by the outer layer of the connection ear and the connection layer to connect the two adjacent artificial leaflets.

2. The valve replacement device according to claim 1, characterized in that: The inner frame is provided with a plurality of leaflet suture holes, the coupling ears and the connecting piece are located on the inner side of the inner frame and are sutured and connected to the inner frame through the leaflet suture holes; The leaflet suture hole is preferably a long strip through hole, a waist-shaped hole, or is composed of a plurality of suture sub-holes distributed along the axial direction.

3. The valve replacement device according to claim 1, wherein: The connecting piece is made of polymer material; And / or, a middle piece is arranged on the connecting piece, and the middle piece is located at the middle outflow end side of the connecting piece.

4. The valve replacement device according to claim 1, wherein: The at least three-layer structure of the coupling ear and the connecting piece are sewn together by a coupling ear sewing line.

5. The valve replacement device according to claim 1, wherein: The coupling ear comprises: an ear portion, one end of which is connected to the artificial valve leaflet; a folding ear, the inflow end of the folding ear being connected to the outflow end of the other end of the ear; After the ear is folded 180° from the circumferential middle to the distal axis, the folded ear is bent 180° from the connection position with the ear to the proximal axis side to form the connecting ear.

6. The valve replacement device according to claim 5, characterized in that: One end of the ear is integrally connected to the artificial valve leaflet, and the inflow end of the folded ear is integrally connected to the outflow end of the other end of the ear; And / or, the folding ear includes an inner folding ear and an outer folding ear. When the ear is folded 180° from the circumferential middle to the distal axis, the inner folding ear and the outer folding ear are stacked together, so that in the formed connected ear, the proximal side of the ear forms a two-layer structure.

7. The valve replacement device according to claim 6, wherein: An avoidance groove is provided between the inner folding ear and the outer folding ear; And / or, the length of the outer folded ear is greater than the length of the inner folded ear, and when the inner folded ear and the outer folded ear are stacked together, the ends of the inner folded ear and the outer folded ear are flush.

8. The valve replacement device according to claim 5, characterized in that: A clip ear is arranged on the outer side of the folded ear, and after the ear portion and the folded ear are folded to form the connecting ear, the clip ear is connected to the side edge of the artificial valve leaflet; And / or, the width of the clip ear located on the side of the artificial valve leaflet decreases from the outflow end to the inflow end of the artificial valve leaflet; And / or, when the folding ear includes an inner folding ear and an outer folding ear, the clamping ear is arranged on the outer side of the outer folding ear, or when the folding ear includes an inner folding ear and an outer folding ear, the clamping ear is arranged on the inner side of the inner folding ear; And / or, when the folded ear includes an inner folded ear and an outer folded ear, the clamping ear is arranged on the inner side of the inner folded ear, and the clamping ear is connected to the outflow end of the artificial valve leaflet.

9. The valve replacement device according to any one of claims 1 to 8, characterized in that: The inner frame comprises: An inner frame body, a hollow cylindrical structure consisting of several layers of inner frame grids; A plurality of connecting rods are evenly connected to the inflow end of the inner frame body along the circumferential direction, and the connecting rods are used to connect with the far end of the external conveying system. The inflow end of the inner frame does not exceed the inflow end of the outer frame in the axial direction.

10. The valve replacement device according to claim 9, wherein: The inflow ends of the plurality of connecting rods are obliquely arranged at the inflow end of the inner frame body, forming a gathering structure that gathers from the outflow end to the inflow end; And / or, the inflow end of the connecting rod is provided with a connecting head for connecting or disconnecting with a conveying system; And / or, the valve replacement device further comprises: a coating mechanism having an inner frame coating, which is coated on the inner frame; And / or, a connector through hole is provided on the connector, and the inflow end of the inner frame is connected to the external conveying system by passing a pull wire through the connector through hole.

11. The valve replacement device according to any one of claims 1 to 8, characterized in that: The valve replacement device further comprises: A plurality of barbs are evenly arranged on the outer peripheral surface of the outer frame along the circumferential direction, and a barb opening facing the inflow end is formed between the barbs and the outer frame; The barbs include: Two barbed rods, one end of the two barbed rods first converges inwards from the outflow end to the inflow end and then expands outwards and then smoothly connects to form an inverted V-shaped structure with rounded corners, the other ends of the two barbed rods are bent inwards toward the inflow end and are respectively connected to the outer peripheral surface of the outer frame, so that the barbs form the barbed openings and the barbed openings have a smoothly transitioned shrinking structure and an outward expansion structure from the outflow end to the inflow end; The outer frame comprises: An external frame body, a hollow cylindrical structure consisting of several layers of external frame grids; A plurality of external connection blocks are evenly connected to the outflow end of the outer frame body along the circumferential direction, and the outer frame is connected to the inner frame through the external connection blocks; The outflow end of the barb in the compressed state does not exceed the outflow end of the outer connecting block.

12. The valve replacement device according to any one of claims 1 to 8, characterized in that: The valve replacement device further comprises: A plurality of barbs are evenly arranged on the outer peripheral surface of the outer frame along the circumferential direction, and a barb opening facing the inflow end is formed between the barbs and the outer frame; The barb is a curved rod, which includes a connecting end, a curved portion and a free end. The connecting end is connected to the outer frame, and the curved portion and the free end form the barb opening.

13. The valve replacement device according to any one of claims 1 to 8, characterized in that: The outer frame comprises: An external frame body, a hollow cylindrical structure consisting of several layers of external frame grids; A plurality of curved connecting rods are evenly connected to the inflow end of the outer frame body along the circumferential direction to form a variable diameter annular structure that first increases and then decreases from the outflow end to the inflow end.

14. The valve replacement device according to claim 13, wherein: The valve replacement device further comprises: a coating mechanism, the coating mechanism comprising an outer frame coating, the outer frame coating covering the outer frame; The inflow end of the curved connecting rod is provided with a blunt through hole, and the inflow end of the external frame is connected to the external frame covering through an external frame suture thread passing through the blunt through hole.

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