Replacement valve devices

Abstract

The present invention belongs to the field of medical device technology, and specifically relates to a valve replacement device, comprising: a stent mechanism having an outer frame and an inner frame connected to the outer frame; a leaflet mechanism located in the inner frame and comprising a plurality of artificial leaflets; the leaflet mechanism further comprising: a plurality of leaflet connection structures, the leaflet connection structures comprising coupling ears and connecting pieces, the outflow end of each artificial leaflet being connected to a coupling ear on both sides, the two ends of the connecting piece being respectively arranged in the coupling ears connecting two adjacent artificial leaflets, the outer layer of the coupling ear and the connecting layer clamping the connecting piece to connect the two adjacent artificial leaflets. The outflow end of the artificial leaflet of the present invention is connected to the inner frame through the leaflet connection structure, and when the leaflet connection structure is connected to the inner frame through sutures, the sutures act on the coupling ear parts of the outer layer and the inner layer, and the connecting layer only needs to withstand the tearing force from the artificial leaflet, and no longer needs to withstand external forces such as tearing of the sutures, thereby increasing the service life of the artificial leaflet.

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 develop lesions such as insufficiency (regurgitation) and valvular stenosis due to congenital or acquired inflammation, which affects the patient's quality of life and may be life-threatening in severe cases.

[0003] Artificial bioprosthetic valves are a device for treating the above-mentioned diseases. Bioprosthetic valves mostly use bovine pericardium or porcine pericardium as the artificial valve leaflet components for opening and closing. 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 to solve the technical problem that after two adjacent leaflets are sutured and connected to a stent, the existing leaflet connection structure is prone to regurgitation due to movement of the leaflets or the stent.

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

[0006] a bracket mechanism comprising an outer frame and an inner frame connected to the outer frame;

[0007] a leaflet mechanism, the leaflet mechanism being located in the inner frame and comprising a plurality of artificial leaflets;

[0008] The leaflet mechanism further comprises:

[0009] A plurality of leaflet connection structures, each having a lug and a connecting piece, wherein each of the artificial valve leaflets is connected to a lug on both sides of the outflow end, the lug having at least three integrally connected layers, an intermediate layer in the lug serving as a connecting layer connected to the artificial valve leaflet, and two ends of the connecting piece respectively disposed in the lug connecting two adjacent artificial valve leaflets, the connecting piece being sandwiched between the outer layer of the lug and the connecting layer to connect the two adjacent artificial valve leaflets;

[0010] Several artificial valve leaflets are connected in sequence through the valve leaflet connection structure to form a central one-way openable and closable structure.

[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 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.

[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 on the outflow end side of the middle portion of the connecting piece.

[0016] Optionally, in the valve replacement device as described above, the at least three layers of the ear are sutured together 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 a connecting ear sewing line.

[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, wherein the inflow end of the folding ear is connected to the outflow end of the other end of the ear;

[0021] After the ear portion is folded 180° from the circumferential middle portion toward the distal axis, the folded ear is bent 180° toward the proximal axis side from the position where it is connected to the ear portion 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 folded ear and the outer folded 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 of the artificial valve leaflet.

[0027] Optionally, in the valve replacement device as described above, the width of the clip ears 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 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;

[0029] Alternatively, 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 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 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 composed 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. The connecting rods are used to connect with the distal 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, forming a collapsed structure that collapses from the outflow end to the inflow end.

[0035] Optionally, in the valve replacement device as described above, the inflow end of the connecting rod is provided with a connector, and the connector may be a card 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 covering mechanism having an inner frame and a film covering 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 a pull wire passing 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 is smoothly connected 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 barb openings and the barb 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 composed 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 curved rod comprising 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.

[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, the 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 curved 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 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 head, 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 through hole, and the inflow end of the external frame is connected to the external frame covering through the blunt 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 through hole.

[0065] The positive progress effect of the present invention is:

[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. The connection layer is mainly fixed by the friction force formed by the squeezing of the ear parts of the outer and inner layers, and no longer needs to withstand external forces such as tearing of sutures, thereby increasing the service life of the artificial valve leaflet.

[0067] 2. When in use, the connecting piece is clamped at each end by the lugs connecting two adjacent artificial valve leaflets, effectively connecting the adjacent prosthetic valve lugs. The connecting piece is made of a polymer material with strong tear resistance, designed to withstand the tearing forces during the opening and closing of adjacent artificial valve leaflets. The median piece is designed to provide positioning, ensuring that the connecting piece is evenly distributed within the adjacent lugs, resulting in a lug with uniform mechanical properties.

[0068] 3. The multi-layer structure of the connecting ear is formed by folding an integrally connected ear portion and a folded ear portion. The ear portion is directly connected to the artificial valve leaflet, greatly simplifying the manufacturing process of the connecting ear. The connecting ear only needs to be made at the same time as the artificial valve leaflet. No sutures are required to sew the connected components together, further reducing wear on the sutures caused by the tearing force of the artificial valve leaflet.

[0069] 4. The clip design, after the joint ear is folded, clamps to the side of the artificial valve leaflet, facilitating better closure of the two ends of the adjacent artificial valve leaflet outflow end. The clip ear with a 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 distal 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. At this time, if it is found that the inflow end of the external frame does not fit the inner wall of the heart perfectly, the angle or position of the entire stent mechanism can be adjusted by adjusting the delivery system and the movable connecting rod, 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, the inner frame can be more securely connected to the external conveying system by pulling the wire through the connector through-hole. Moreover, 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 barb rods, there is no fixed point in the middle part where the two barb rods are connected. Therefore, when the barbs are compressed, the barb rods will easily deform because there are not too many fixed constraint points. If the barb rods are too long, the barb rods may interfere with the external connection block in the 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 barb in the compressed state does not exceed the outflow end of the external connection block, even if the barb rods are deformed, they cannot be sleeved on the external connection block. When the barb adopts an independent curved rod structure, compared with the design of two barb rods, it avoids the problem of excessive interference of the barbs during compression during transportation. In the compressed state, regardless of whether the outflow end of the curved rod exceeds the outflow end of the external connection block, the phenomenon of the curved rod sleeved on the external connection block will not occur.

[0074] 8. In order to increase the contact area between the curved rod and the native leaflet, the width of the curved rod from the curved portion to the free end is greater than the width of the curved rod from the curved portion to the connecting end, thereby increasing the contact area between the curved portion 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 equal widths. In this case, a stabilizing plate needs to be provided on the curved rod between the curved portion and the free end, thereby increasing the contact area between the curved portion 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 portion to the free end becomes smaller and smaller. This is because when the curved rod clamps the native leaflet, since the free end is farthest from the curved portion, its clamping force is relatively small relative to the part close to the curved portion. Therefore, a stabilizing plate with a relatively high density is provided at the free end to increase the bonding 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 and density of stabilizing plates in the curved portion also helps reduce the contact area between the curved portion and the native leaflet. Since the native leaflet is relatively soft, it helps the curved portion to sink into the native leaflet to a certain extent (i.e., the native leaflet is concave and deformed), thereby promoting the free end to fit the native leaflet better. On the contrary, if the native leaflet at the curved portion is particularly thick and there are too many stabilizing plates, the curved portion cannot sink into the native leaflet due to the large contact area, which may cause the free end to tilt, and the free end may not be able to play the role of clamping the native leaflet. In order to increase the bending force of the bending rod, a bending block is added to the curved portion so that the curved portion can provide a greater bending retention force after bending, which is beneficial for the bending rod to clamp the native leaflet.

[0075] 5. The inflow end of the external frame is designed with several curved links, replacing the traditional grid-shaped outward skirt. Whether compressed and straightened or bent after expansion, the lengths of the proximal and distal ends of the curved links remain unchanged. Therefore, the film will not tear during compression and expansion, ensuring smooth compression of the inflow end of the external frame. Compared to a grid-shaped outward skirt, the curved links offer greater flexibility and circumferential wiggle room, allowing them to better adapt to the shape of the heart's inner wall.

[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 punctured. 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 puncturing the heart. 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 sutures 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. 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 equipment, 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 for illustrative purposes only 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) Schematic diagram of a connection relationship between the lug and the artificial valve leaflet in various embodiments of the present invention;

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

[0080] Figure 3 A diagram showing the positional relationship between the ear portion and the folded ear formed by bending the connected ear and the artificial valve leaflet in FIG1(c);

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

[0082] Figure 5 for Figure 3 Diagram of the positional relationship between the lugs, artificial valve leaflets and connecting pieces;

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

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

[0085] Figure 7 FIG1( d ) is a diagram showing the positional relationship between the ear and the artificial valve leaflet formed by bending the ear and the folded ear;

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

[0087] Figure 9 This is a schematic diagram of an application of the present invention;

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

[0089] FIG10( b ) is a perspective 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] FIG11( a ) is a front view of the outer frame in FIG10( a );

[0093] Figure 11(b) is a schematic diagram of the compressed state of Figure 11(a);

[0094] Figure 11(c) is a partial enlarged view of Figure 11(b);

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

[0096] FIG12( b ) is a perspective view of FIG12( a );

[0097] Figure 12(c) is a schematic diagram of the compressed state of Figure 12(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] Figure 12(e) is a partial enlarged view of Figure 12(d);

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

[0101] FIG13( c ) is a position distribution diagram of the stabilizing plate on the curved rod according to the present invention;

[0102] Figure 13(d) is a partial enlarged view of Figure 13(c);

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

[0104] Figure 13(f) is a partial enlarged view of Figure 13(e);

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

[0106] FIG14( a ) is a diagram of an implantation process of FIG10( 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. Those skilled in the art will readily understand the other advantages and benefits of the present invention from the disclosure herein. The present invention may also be implemented or applied through various other specific embodiments, and the details in this specification may be modified or altered based on different perspectives and applications without departing from the spirit of the present invention.

[0109] It should be noted that, unless there is any conflict, the following embodiments and features therein may be combined with each other.

[0110] In the description of the present invention, it should be noted that, for directional words, such as the terms "outside", "middle", "inside", "outside", etc., the directions and positional relationships indicated are based on the directions or positional relationships shown in the accompanying 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 scope of protection of the present invention.

[0111] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features. Therefore, the terms "first" and "second" may explicitly or implicitly refer to one or more of these features. Throughout the description of the present invention, "several" and "a number" mean two or more, unless otherwise specifically defined.

[0112] In this application, when describing artificial valve leaflets or joint ears, "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" means the end where antegrade blood first flows into the interventional medical device, such as the lower end in Figure 1(a). "Outflow end" means 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 Figure 9The axial direction of the middle bracket is also the up-down direction, and the “radial direction” refers to the direction perpendicular to the above “axial direction”.

[0113] In this application, when describing a prosthetic valve leaflet or a joint, such as Figure 9 As shown, the "proximal side" refers to the side of the artificial valve leaflet close to the stent axis A after being installed on the stent. Correspondingly, the "distal side" refers to the side of the artificial valve leaflet away from the stent axis A after being installed on the stent.

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

[0115] An embodiment of the present invention provides a replacement valve device comprising a stent mechanism and a leaflet mechanism. The stent mechanism comprises an outer frame 100 and an inner frame 200. The inner frame 200 is typically disposed within and connected to the outer frame 100. The leaflet mechanism is located within the inner frame 200 and functions like a one-way valve, effectively preventing reflux.

[0116] The leaflet mechanism includes several artificial leaflets 500 and several leaflet connection structures 600. Figure 9 The leaflet connecting 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 connecting structure 600, that is, the artificial leaflet 500 is not directly connected to the inner frame 200, but is indirectly connected through the leaflet connecting structure 600.

[0117] The leaflet connection structure 600 of the present invention includes a connecting ear 610 connected to the artificial leaflet 500. Each artificial leaflet 500 is connected to a connecting ear 610 on both sides of the outflow end. The connecting ear 610 is bent at the side of the outflow end of the artificial leaflet 500. The connecting ear 610 has at least three layers, namely, an outer layer located on the distal axis side, an inner layer located on the proximal axis side, and several intermediate layers located between the outer layer and the inner layer. One of the several intermediate layers is connected to the artificial leaflet 500 as a connecting 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 serves as a connecting layer connected to the artificial valve leaflet 500.

[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. The fixing of the connecting layer mainly relies on the friction force formed by the squeezing of the connecting ear parts of the outer layer and the inner layer, and no longer needs to withstand external forces such as tearing of sutures, 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 connecting piece 620, one end of which is disposed between the outer layer and the connecting layer of the coupling ear 610. The coupling ear 610 clamps the connecting piece 620 to connect two adjacent artificial valve leaflets 500. Several artificial valve leaflets 500 are sequentially connected by the leaflet connection structure 600 to form a central structure that can be opened and closed in one direction.

[0120] In a specific implementation, as shown in Figures 6(a) and 6(b), the two ends of the connecting piece 620 are respectively disposed 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 via the connecting ears 610 and the connecting piece 620. In this case, a connecting piece 620 is disposed on both sides of the outflow end of an artificial valve leaflet 500, and the outflow ends of two adjacent artificial valve leaflets 500 share a connecting piece 620, so that multiple artificial valve leaflets 500 are sequentially connected via 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 polymer connecting piece 620 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 center piece 621, which is located at the middle outflow end side of the connecting piece 620. The design of the center 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 a connecting ear 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 those used when connecting the ear 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 can 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 . 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), when 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. The two connected 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 portion 611 is folded 180° from the circumferential middle toward the distal axis, the folded ear 612 is bent 180° toward the proximal axis from the connection position with the ear portion 611 to form the connecting ear 610. At this time, the connecting ear 610 has a three-layer structure.

[0130] When the leaflet connection structure 600 has the coupling piece 620 , the coupling 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 integrated design of the artificial valve leaflet 500 and the connecting ear 610 requires only that the connecting ear 610 be manufactured together with the artificial valve leaflet 500. Furthermore, sutures are not required between the integrally connected artificial valve leaflet 500 and the ear 611, and between the ear 611 and the folded ear 612, further reducing wear on the sutures caused by the tearing force of the artificial valve leaflet 500.

[0132] In some embodiments, referring to FIG1(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 portion 611 is folded 180 degrees from the circumferential middle portion to the distal axis, as shown in FIG1(c), the inner folded ear 6121 is located on the inner side of the outer folded ear 6122. Figure 2As shown, the inner folding ear 6121 and the outer folding ear 6122 are stacked together, and the inner folding ear 6121 and the outer folding ear 6122 are bent 180 degrees 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 the inner folded ear 6121 and the outer folded ear 6122 form a two-layer structure on the proximal side of the ear portion 611.

[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 two-layer structure of the folded ear 612 can better withstand the tension.

[0134] 1( c ), an escape groove 6123 is provided between the inner folding ear 6121 and the outer folding ear 6122. The escape groove 6123 can reduce the internal stress caused by the reverse folding of the link ear 610, or prevent the link ear 610 from folding and deforming due to accumulation of material at the fold.

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

[0136] Because the outer folded ear 6122 is wrapped around the outer side of the inner folded ear 6121, when the outer folded ear 6122 is longer than the inner folded ear 6121, the ends of the inner folded ear 6121 and the outer folded ear 6122 can be flush after the connecting ear 610 is folded. 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 based on the thickness of different artificial valve leaflets 500 and can be obtained without creative effort by a person skilled in the art.

[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 closure of the two ends of the outflow end of the adjacent artificial valve leaflet 500.

[0138] In some embodiments, the clip ears 613 can be connected to the artificial valve leaflet 500 by sutures.

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

[0140] In some embodiments, reference Figure 7 The width of the clip ears 613 located on the side of the artificial valve leaflet 500 decreases gradually from the outflow end to the inflow end of the artificial valve leaflet 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 leaflet 500.

[0141] In some embodiments, referring to FIG1(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 FIG1(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. This design makes the connection between the artificial valve leaflet and the connecting ear of the two-layer structure formed after folding, and improves the tear resistance of the connection.

[0144] In some embodiments, the connecting ears 610 with a multi-layer structure are respectively connected to both sides of the outflow end of each artificial valve leaflet 500, and the adjacent two artificial valve leaflets 500 are connected through 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 connecting ear 610 is sutured to the inner frame 200 by sutures. Here, the sutures used for the connecting ear 610 can be thinner than the sutures used to suture the connecting ear 610 to the inner frame 200. Since the space for the stent to fix the connecting ear 610 is limited, relatively thick sutures are used to fix the connecting ear 610 and the inner frame 200. A more secure fixation of the connecting ear 610 can be achieved by suturing with fewer suture needles. During suturing, the stent sutures pass through the outer and inner layers of the connecting 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 several 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 circumference, and the connecting rods 220 are used to connect to the distal end of the external delivery system. By arranging the connecting rods 220 at the inflow end of the inner frame body 210, the connecting rods 220 are connected to 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 inflow end is released and expanded.

[0146] In some embodiments, the inflow ends of the connecting rods 220 are tilted to the inflow end of the inner frame body 210, and the connecting rods 220 form a retracted structure that is retracted from the outflow end to the inflow end, which is convenient for connection with the conveyor.

[0147] In some embodiments, referring to FIG12( a ), a connector 221 is provided at the inflow end of the connecting rod 220 . The connector 221 may be a snap-fit ​​connector having a circular, oval, or rectangular structure. The connector 221 is used to snap-fit ​​with the delivery system to facilitate connection or separation with the delivery system.

[0148] In some embodiments, the valve replacement device further includes a coating mechanism having 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 within 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 will 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 will more strongly impact and abut 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 connecting blocks 230, which are uniformly connected along the circumference to the outflow end of the inner frame body 210. In this case, the inner frame 200 includes a plurality of connecting rods 220, the inner frame body 210, and the inner connecting blocks 230, which are sequentially connected from the inflow end to the outflow end. The inner frame 200 is connected to the outer frame 100 via the inner connecting blocks 230. Preferably, the inner frame 200 is connected to the outer frame 100 by connecting the inner connecting blocks 230 to the outer connecting blocks 130.

[0152] In some embodiments, as shown in Figures 11(a) and 12(a), both the external connecting block 130 and the internal connecting block 230 have outflow-end folding structures that converge toward the outflow end. The outflow-end folding structures have a folding angle α, with 45°≤α≤75°. Excessively large folding angles can affect the endothelialization rate at the outflow end of the external frame 100 or the internal frame 200. Therefore, an appropriate folding angle can ensure a satisfactory endothelialization rate while protecting the heart's inner wall from collision and puncture caused by the distal end of the external connecting block 130 or the internal connecting block 230.

[0153] In some embodiments, the outer diameter of the inner frame 200 is no 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 portion of the inner frame 200 to the inflow end is suspended inside the outer frame 100. This ensures that, except for the connection between the inner frame 200 and the outer frame 100, the rest of the inner frame 200 is suspended inside the outer frame 100. This minimizes the impact on the shape of the inner frame during cardiac contraction and expansion, prevents deformation of the leaflet mechanism at the coaptation site, and reduces regurgitation of the prosthetic heart valve.

[0154] In some embodiments, referring to FIG12( a ), the inner frame body 210 comprises a hollow, cylindrical structure formed by two layers of inner frame mesh. The outflow end of the inner frame body 210 is a collapsed structure. The mesh shapes of the two layers of outer frame mesh can be designed to be the same or different as needed. The two layers of mesh shown in FIG12( a ) utilize different mesh shapes.

[0155] In some embodiments, as shown in FIG12( a ), each layer of the inner frame grid is connected by connecting posts 240 , and two adjacent layers of polygonal frames are heat-set to form the inner frame body 210 . The connecting posts 240 of the inner frame grid layer closest to the outflow end are provided with leaflet suture holes 241 , which allow the inner frame 200 to be sutured to the leaflet connection structure 600 .

[0156] Specifically, the connecting ears 610 and the connecting pieces 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 through 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 along the circumference on the connecting post 240. Alternatively, each connecting post 240 may be provided with a leaflet suture hole 241.

[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 FIG12( e ), two suture sub-holes 2411 are arranged side by side along the axial direction to form a set of leaflet suture holes 241. With this design, as shown in FIG9 , the leaflet connection structure 600 can be well fitted to the inner side of the inner frame 200. Furthermore, the outer portion of the suture thread connected to the leaflet connection structure 600 is wrapped around the connecting post 240 between two adjacent suture sub-holes 2411, further preventing the suture thread from tearing or abrading the outer layer of the leaflet connection structure 600.

[0161] In some embodiments, the suture sub-hole 2411 is an elongated 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 circumferential 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 FIG11( a ), the barb 400 includes two barb rods 420 . One end of the two barb rods 420 first converges inward from the outflow end to the inflow end, then expands outward and smoothly connects to form an inverted V-shaped structure with rounded corners. The other ends of the two barb rods 420 bend inward toward the inflow end and are respectively connected to the outer peripheral surface of the external frame 100 , thereby forming a barb opening 410 . The barb opening 410 has a smoothly transitioned contraction 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 leaflet 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 adheres to the inner wall of the right ventricle. The barb 400 anchors the valve, reducing damage to the tissue caused by the external frame 100. During right ventricular contraction, the resistance of the valve leaflets to the stent mechanism, as well as the friction between the stent mechanism and the right ventricular wall, are offset by the upward thrust of the stent mechanism due to right ventricular pressure through barbs 400. The constricted structure of barbs 400 increases the clamping force between barbs 400 and the valve leaflets. The outward flared structure of barbs 400 increases friction with the right ventricular wall, and the curved outward flared end prevents puncture of the right ventricular wall.

[0164] In some embodiments, referring to Figure 11(a), an external frame 100 includes an external frame body 110 and a plurality of external connection blocks 130. The external frame body 110 is a hollow, cylindrical structure formed by multiple layers of external frame grids. The plurality of external connection blocks 130 are evenly connected to the outflow end of the external frame body 110 along the circumference. The external frame 100 is connected to the inner frame 200 via the external 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.Barb 400 needs to be straightened with barb 400 in the process of conveying replacement valve device, as shown in Figure 11 (b) and Figure 11 (c), 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 where two barb rods are connected does not have a fixed point, so when barbs are compressed, barb rods can be easily deformed because there are not too many fixed constraint points. If barb rods are too long, barb rods may occur in compressed state, interfere with outer connecting block, and make barb enclosed on outer connecting block, and cannot expand and open.By the mode that the outflow end of barb in compressed state does not exceed outer connecting block outflow end, even if barb rods are deformed, they cannot be enclosed on outer connecting block.

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

[0167] The inflow end of the conventional external frame 100 is typically formed by directly expanding the external frame grid of the external frame body 110 to form an outwardly expanded skirt. Since the axial length of the compressed external frame grid can become very long, it can severely tear the external frame coating 300. Therefore, the present invention abandons this structure and uses a plurality of curved links 120 to replace the traditional outwardly expanded skirt. Whether the curved links 120 are compressed and straightened or in a bent state after expansion, the length of the proximal and distal ends of the curved links 120 does not change. Therefore, the compression and expansion processes do not cause tearing of the coating, achieving smooth compression of the inflow end of the external frame. Compared to the grid-shaped outwardly expanded skirt, the curved links 120 are more flexible and have a certain amount of circumferential movement space, so the curved links 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 flared outward and smoothly connected to the outflow end of the curved connecting rod 120. This allows the outer frame 100 to quickly expand to the target size after release. This also avoids the risk of the outer frame body 110 and the curved connecting rod 120 being broken during compression.

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

[0170] In some embodiments, referring to FIG11( 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, the diameter of which is greater than the width of the curved connecting rod 120. Providing a larger protective blunt tip 121 at the inflow end of the curved connecting rod 120 provides a larger tip at the inflow end of the curved connecting rod 120, further preventing it from piercing the heart.

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

[0172] Referring to Figure 11(a), a blunt through-hole 122 is provided on the blunt tip or protective blunt tip 121. The inflow end of the external frame 100 is connected to the external frame membrane 300 by sutures passing through the blunt through-hole 122. The blunt through-hole design allows the external frame membrane to be connected to the external frame inflow end by sutures passing through the blunt through-hole, preventing the external frame membrane from sliding along the curved connecting rod, and ensuring that the position of the external frame membrane and the external frame inflow end remains stable during the implantation of the stent mechanism.

[0173] In some embodiments, a marker is embedded within the blunt through-hole 122. The marker is made of a radiopaque material. Embedding the marker within the blunt through-hole 122 provides a distinct imaging point at the inflow end of the external frame 100 under imaging equipment, making it easier for operators to confirm whether the inflow end of the external frame 100 meets the required position.

[0174] In some embodiments, the blunt through hole 122 is an elongated through hole or a waist-shaped hole. The design of the elongated 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 is passed through.

[0175] In some embodiments, referring to FIG11( a ), the outer frame body 110 comprises a hollow, cylindrical structure formed by three layers of outer frame mesh. The inflow end of the outer frame body 110 has an outwardly flared structure, while the outflow end has a converged structure. The mesh shapes of the three layers of outer frame mesh can be designed to be the same or different as needed. The three layers of mesh shown in FIG11( a ) utilize different mesh shapes. When barbs 400 are designed on the outer frame body 110, the barbs 400 are located on the layer of outer frame mesh near the outflow end. Preferably, they are located on the side of the inflow end of the converged structure.

[0176] Reference Figure 13(a) to Figure 13(f) The embodiment of 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 rest of the structures are the same.

[0177] In some embodiments, the barb 400 adopts a curved rod 430, which 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 a single independent curved rod 430 structure, compared to a design 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. 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 curved rod 430 will not be sleeved on the outer connecting block 130.

[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. To increase the contact area between the curved rod 430 and the native leaflets, 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 leaflets, thereby further increasing the stability of the barbs 400 in clamping the native leaflets.

[0179] In some embodiments, referring to Figures 13(c) and 13(d), the width of the rod from the curved portion 432 to the free end 433 is equal to the width of the rod from the curved portion 432 to the connecting end 431. A stabilizing plate 434 is provided on the curved rod 430 between the curved portion 432 and the free end 433. The width of the stabilizing plate 434 is greater than the width of the curved rod 430. To reduce the weight of the curved rod 430, the curved rod 430 can also be designed to have equal widths. In this case, the 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, the 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 FIG13(a) and FIG13(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 FIG13(c) and FIG13(d), when there are multiple stabilizing plates 434, the distance 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, the free end 433 is farthest from the bending portion 432, so its clamping force is relatively small relative to the part close to the bending portion 432. Therefore, the free end 433 is provided with a relatively large density of stabilizing plates 434, which can increase the bonding 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 number density of the stabilizing plates 434 in the curved portion 432 is small, which 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 Figures 13(e) and 13(f), the curved portion 432 is provided with a bending block 435, the width of which is greater than the width of the curved rod 430. To increase the bending force of the curved rod 430, the bending 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 helps the curved rod 430 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 or 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 the replacement valve device is placed in the predetermined position, the outer tube 910 of the delivery system first retreats 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 delivery system penetrates the interior of the stent mechanism. The distal end of the inner tube 920 is used to collect the inflow end of the stent mechanism 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 by the distal end of the outer tube 910. When releasing the stent mechanism, as shown in FIG14( b ), the outflow end of the stent mechanism is first 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 by 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, it is observed 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, which in turn drives 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 of the present invention, 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 the 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 the control pull wire to pass through, thereby controlling the angle of the barb opening 410 by controlling the pull wire.

[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 leaflet. Even if the barb 400 fails to capture, the control pull line can be used to open the barb 400 again to recapture the native leaflet. Each barb 400 of this embodiment can independently control the opening and closing of the barb 400 through its independent control pull line, and can open different angles at different times and maintain different times. Therefore, the differences in the three leaflets of the native leaflet are effectively addressed. The difference in the required opening angle or time of the barb 400 is beneficial for the replacement valve device to capture all the native leaflets, or for all the barbs 400 to capture the 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 operational 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, the end of the free end 433 of the bending rod 430 is provided with a wire hole, and the rest of the structure is the same.

[0194] The present invention has been described in detail above with reference to the embodiments of the accompanying drawings. A person skilled in the art can make various modifications to the present invention based on the above description. Therefore, certain details in the embodiments should not be construed as limiting the present invention. The scope of protection of the present invention shall be determined by the scope defined by the appended claims.

Claims

1. A valve replacement device, comprising: a bracket mechanism comprising an outer frame and an inner frame connected to the outer frame; a leaflet mechanism, the leaflet mechanism being located in the inner frame and comprising a plurality of artificial leaflets; Characterized in that the leaflet mechanism further comprises: A plurality of leaflet connection structures, each having a lug and a connecting piece, wherein each of the artificial valve leaflets is connected to a lug on both sides of the outflow end, the lug having at least three integrally connected layers, an intermediate layer in the lug serving as a connecting layer connected to the artificial valve leaflet, and two ends of the connecting piece respectively disposed in the lug connecting two adjacent artificial valve leaflets, the connecting piece being sandwiched between the outer layer of the lug and the connecting layer to connect the two adjacent artificial valve leaflets; The inner frame is provided with a plurality of leaflet suture holes, the coupling ears and the coupling piece are located on the inner side of the inner frame and are sutured to the inner frame through the leaflet suture holes; The connecting ear comprises an ear portion and a folding ear, wherein the side close to the artificial valve leaflet is the inner side and the side away from the artificial valve leaflet is the outer side, the inner side of the ear portion is connected to the outer side of the outflow end of the artificial valve leaflet, and the inflow end of the folding ear portion is connected to the outflow end of the outer side of the ear portion, and the two connecting ears form two opposite L-shaped structures on both sides of the outflow end of the artificial valve leaflet; the connecting ear is formed by bending the ear portion 180° from the circumferential middle portion toward the distal axis and then bending the folding ear 180° from the connection position with the ear portion toward the proximal axis. 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; A clamping ear is provided on the outer side of the folded ear. After the ear and the folded ear are folded to form the connecting ear, the clamping ear is connected to the side of the artificial valve leaflet. The width of the clamping ear located on the side of the artificial valve leaflet decreases from the outflow end to the inflow end of the artificial valve leaflet.

2. The valve replacement device according to claim 1, wherein: The leaflet suturing hole is a long strip through hole, a waist-shaped hole, or is composed of a plurality of suturing 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 provided 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 pieces are sewn together by coupling ear sutures.

5. The valve replacement device according to claim 1, wherein: 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.

6. The valve replacement device according to claim 5, wherein: An avoidance groove is provided between the inner folding ear and the outer folding ear; And / or, the length of the outer folding ear is greater than the length of the inner folding ear, and when the inner folding ear and the outer folding ear are stacked together, the ends of the inner folding ear and the outer folding ear are flush.

7. The valve replacement device according to claim 5, wherein: The clip ear is arranged on the outside of the outer folding ear, or the clip ear is arranged on the inside of the inner folding ear; The clip ear is connected to the outflow end of the artificial valve leaflet.

8. The valve replacement device according to any one of claims 1 to 7, wherein: The inner frame comprises: An inner frame body, a hollow cylindrical structure composed 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. The connecting rods are used to connect with the distal 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.

9. The valve replacement device according to claim 8, wherein: The inflow ends of the plurality of connecting rods are obliquely arranged at the inflow end of the inner frame body, forming a retracted structure that converges from the outflow end to the inflow end; And / or, the inflow end of the connecting rod is provided with a connector for connecting to or disconnecting from a delivery system; And / or, the valve replacement device further comprises: a covering mechanism having an inner frame covering, covering 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 a pull wire passing through the connector through hole.

10. The valve replacement device according to any one of claims 1 to 7, wherein: The valve replacement device further comprises: A plurality of barbs are uniformly 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 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 barb openings, and the barb openings have a smoothly transitioned shrinking structure and an outward expansion structure from the outflow end to the inflow end; The outer frame includes: An external frame body, a hollow cylindrical structure composed 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.

11. The valve replacement device according to any one of claims 1 to 7, wherein: The valve replacement device further comprises: A plurality of barbs are uniformly 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 comprising 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.

12. The valve replacement device according to any one of claims 1 to 7, wherein: The outer frame includes: An external frame body, a hollow cylindrical structure composed 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.

13. The valve replacement device according to claim 12, wherein: The valve replacement device further comprises: a covering mechanism, the covering mechanism comprising an outer frame covering, the outer frame covering 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.

Images