Prosthetic valve capable of being loaded in two directions

Abstract

The invention provides an artificial valve capable of being loaded bidirectionally. The artificial valve capable of being loaded bidirectionally comprises a valve frame, a film covering the valve frame, at least two artificial valve leaflets capable of being opened and closed oppositely and a plurality of loading rods. The artificial valve leaflet is fixedly connected to the valve frame or / and the membrane; the loading rod is rotatably connected to the valve frame and is configured to selectively and axially protrude out of the first end or the second end of the valve frame so as to be loaded by a valve conveying device; alternatively, the loading rod is configured to be selectively connected with and axially protrude out of the first end or the second end of the valve frame so as to be loaded by the valve conveying device. The artificial valve capable of being loaded in the two directions breaks through the limitation in the aspects of an intervention mode and a native valve suitable for replacement, and the application range is obviously widened.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an artificial valve capable of being loaded bidirectionally. Background Art

[0002] Human heart valves include the aortic valve, atrioventricular valves, etc., among which the atrioventricular valves include the mitral valve and tricuspid valve. These valves act as one-way valves that work synchronously with the heart, allowing blood to flow downstream but preventing blood from flowing upstream. For example, the mitral valve allows blood to flow from the left atrium to the left ventricle, but prevents blood from flowing from the left ventricle to the left atrium; the tricuspid valve allows blood to flow from the right atrium to the right ventricle, but prevents blood from flowing from the right ventricle to the right atrium; the aortic valve allows blood to flow from the left ventricle to the aorta, but prevents blood from flowing from the aorta to the left ventricle.

[0003] Heart valve disease can cause hemodynamic changes, leading to lesions in the heart and blood vessels. Traditional treatments for valvular disease include drug therapy and surgical procedures with corresponding surgical indications. Among them, drug therapy has limited effects, and surgical procedures usually require thoracotomy, which is too invasive and requires extracorporeal circulation, and has a high incidence of complications and infection risks.

[0004] In recent years, transcatheter interventional treatment technology has developed rapidly. For severe valvular diseases, artificial valves can be used to replace diseased native heart valves.

[0005] Minimally invasive interventions for artificial valves include transcatheter and transapical. In addition, the orientation of the free ends of the leaflets of the artificial atrioventricular valve is opposite to that of the leaflets of the artificial aortic valve. The position of the loading part where the existing artificial valve is connected to the delivery system is single, so there are limitations in the intervention method and the native valve suitable for replacement: for the same native valve, the transcatheter artificial valve is not suitable for transapical delivery, and the transapical artificial valve is not suitable for transcatheter delivery; for the same transcatheter method or the same transapical method, the artificial atrioventricular valve cannot be used for aortic valve replacement, and the artificial aortic valve cannot be used for atrioventricular valve replacement. Summary of the invention

[0006] In view of this, the present invention aims to provide an artificial valve that can solve the above problems.

[0007] An artificial valve provided by the present invention includes a valve frame, a membrane covering the valve frame, at least two artificial valve leaflets that can open and close relative to each other, and a plurality of loading rods; the artificial valve leaflets are fixedly connected to the valve frame and / or the membrane; the loading rods can be rotatably connected to the valve frame and are configured to selectively protrude axially from the first end or the second end of the valve frame so as to be loaded by a valve delivery device.

[0008] In some embodiments, the valve frame includes a plurality of rows of grids, and the loading rod is rotatably connected to a node of the grid located in the axial middle of the valve frame.

[0009] Preferably, the loading rod is located radially outside the valve frame.

[0010] Preferably, the length of the loading rod is at least greater than the axial length of the grid in the clamped state, so that the loading rod rotates toward the first end of the valve frame until it axially protrudes from the first end of the valve frame, or the loading rod rotates toward the second end of the valve frame until it axially protrudes from the second end of the valve frame.

[0011] In some embodiments, the valve rack includes several rows of grids, and the plurality of loading rods include several first loading rods and several second loading rods, wherein the first loading rod can be rotatably connected to the node of the grid where the first end of the valve rack is located, and the second loading rod can be rotatably connected to the node of the grid where the second end of the valve rack is located.

[0012] Optionally, the first loading rod is located radially outside or radially inside the valve frame; the second loading rod is located radially outside or radially inside the valve frame.

[0013] Preferably, the first loading rod may be constrained to a rod of the grid at which the first end of the valve frame is located, and the second loading rod may be constrained to a rod of the grid at which the second end of the valve frame is located; the constraint on the second loading rod is maintained and the constraint on the first loading rod is released to allow the first loading rod to rotate to axially protrude from the first end of the valve frame; or the constraint on the first loading rod is maintained and the constraint on the second loading rod is released to allow the second loading rod to rotate to axially protrude from the second end of the valve frame.

[0014] In some embodiments, the loading rod is rotatably connected to the valve frame via a pin.

[0015] In some embodiments, a limiting structure is provided between the valve frame and the loading rod to keep the loading rod axially protruding from the first end or the second end of the valve frame.

[0016] Another artificial valve provided by the present invention includes a valve frame, a membrane covering the valve frame, at least two artificial valve leaflets that can open and close relative to each other, and a plurality of loading rods; the artificial valve leaflets are fixedly connected to the valve frame and / or the membrane; the loading rods are configured to be selectively connected and axially protrude from the first end or the second end of the valve frame so as to be loaded by the valve delivery device.

[0017] In some embodiments, a plurality of first docking portions are provided at the first end and the second end of the valve frame, and a second docking portion is provided on the loading rod. The second docking portion can selectively be mutually interlocked with the first docking portion located at the first end of the valve frame or mutually interlocked with the first docking portion located at the second end of the valve frame, and a sleeve is movably provided on the loading rod, and the sleeve is used to wrap the mutually interlocking portion of the first docking portion and the second docking portion.

[0018] Preferably, a clamping portion adjacent to the second docking portion is provided on the loading rod, and the clamping portion is used to clamp the sleeve to keep the sleeve wrapping the mutually embedded portion of the first docking portion and the second docking portion.

[0019] The artificial valve provided by the present invention can achieve bidirectional loading by adopting any of the above technical solutions. For the same native diseased valve, the bidirectionally loadable artificial valve can be connected and loaded on the valve delivery device using a loading rod protruding from the first end of the valve frame, suitable for one of the interventional methods of transcatheter or transapical, or can be connected and loaded on the valve delivery device using a loading rod protruding from the second end of the valve frame, suitable for the other of the interventional methods of transcatheter or transapical. For the same interventional method of transcatheter or transapical, the bidirectionally loadable artificial valve can be connected and loaded on the valve delivery device using a loading rod protruding axially from the first end or the second end of the valve frame, deployed in a first orientation to replace the native aortic valve; it can also be connected and loaded on the valve delivery device using a loading rod protruding axially from the corresponding other end of the valve frame, deployed in a second orientation inverted relative to the first orientation to replace the native atrioventricular valve. Compared with the prior art, the bidirectionally loadable artificial valve of the present invention breaks through the limitations in terms of interventional methods and native valves suitable for replacement, and its scope of application is significantly broadened. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is a schematic diagram of the three-dimensional structure of a bidirectionally loadable artificial valve according to an embodiment of the present invention;

[0021] Figure 2 for Figure 1 A schematic diagram showing that the first loading rod and the second loading rod are both bound to the valve frame;

[0022] Figure 3 for Figure 1 Schematic diagram of the mid-valve frame;

[0023] Figure 4 for Figure 3 The enlarged schematic diagram of point B in the middle;

[0024] Figure 5 for Figure 1 A schematic structural diagram of the first loading rod in FIG.

[0025] Figure 6 for Figure 1 The enlarged schematic diagram of point A in the middle;

[0026] Figure 7 for Figure 6 A schematic longitudinal section of the indicated part;

[0027] Figure 8 for Figure 1 Schematic diagram of a prosthetic valve replacing the native aortic valve via transcatheter intervention;

[0028] Fig. 9 for Figure 1 Schematic diagram of the prosthetic valve replacing the native aortic valve via transapical approach;

[0029] Fig.10 for Figure 1 Schematic diagram of the artificial valve replacing the native mitral valve through transcatheter intervention;

[0030] Fig.11 for Figure 1 Schematic diagram of the prosthetic valve replacing the native mitral valve via transapical approach;

[0031] Fig.12 for Figure 1 Schematic diagram of the prosthetic valve replacing the native tricuspid valve via transcatheter intervention;

[0032] Fig.13 for Figure 1 Schematic diagram of the prosthetic valve replacing the native tricuspid valve via transapical approach;

[0033] Fig.14 It is a schematic diagram of the three-dimensional structure of an artificial valve capable of bidirectional loading according to another embodiment of the present invention;

[0034] Fig.15 for Fig.14 A schematic diagram of a loading rod being rotated to a first end axially protruding from a valve frame;

[0035] Fig.16 for Fig.15 The enlarged schematic diagram of the center C;

[0036] Fig.17 for Fig.15 Schematic diagram of the valve frame and the loading rod in the pressed and gripped state;

[0037] Fig.18 for Fig.15 Schematic diagram of the structure of the middle valve frame;

[0038] Fig.19 for Fig.15A schematic diagram of the structure of the loading rod in one viewing angle;

[0039] Fig. 20 for Fig.15 A schematic diagram of the structure of the loading rod in another perspective;

[0040] Fig.21 for Fig.14 A schematic cross-sectional view of the artificial valve shown in the state where the loading rod axially protrudes from the first end of the valve frame;

[0041] Fig. 22 for Fig.21 The enlarged schematic diagram of F in the middle;

[0042] Fig.23 for Fig.21 The enlarged schematic diagram of the H in the middle;

[0043] Fig.24 for Fig.14 A schematic cross-sectional view of the artificial valve shown in the state where the loading rod axially protrudes from the second end of the valve frame;

[0044] Fig.25 This is a schematic diagram of the three-dimensional structure of a bidirectionally loadable artificial valve according to another embodiment of the present invention;

[0045] Fig.26 for Fig.25 Schematic diagram of the three-dimensional structure of the middle valve frame;

[0046] Fig. 27 for Fig.26 The enlarged schematic diagram of the N position in the middle;

[0047] Fig.28 for Fig.26 The enlarged schematic diagram of R in the middle;

[0048] Fig.29 for Fig.25 A schematic diagram of the structure of the middle loading rod and sleeve;

[0049] Fig.30 for Fig.25 The enlarged schematic diagram of the M in the middle;

[0050] Fig.31 for Fig.30 A perspective schematic diagram of the parts shown. DETAILED DESCRIPTION

[0051] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. In addition, the embodiments described below can be combined with each other as long as there is no contradiction or conflict, and the same or similar concepts or processes may not be repeated in some embodiments.

[0052] First of all, it should be noted that in this article, "proximal end" refers to the end of the device or component close to the operator, and "distal end" refers to the end of the device or component away from the operator; "inflow end" refers to the end located upstream of the blood, and "outflow end" refers to the end located downstream of the blood; "axial" refers to the direction that coincides with or is parallel to the central axis of the device or component. "Radial" refers to the direction that is perpendicular or approximately perpendicular to the axial direction and along the radius or diameter of the device or component. "Circumferential" refers to the direction surrounding the axial direction. For artificial valves used to replace atrioventricular valves or aortic valves, the upper and lower parts are distinguished in the axial direction according to the actual placement orientation or the illustrated orientation.

[0053] It is worth noting that the above-mentioned terms indicating orientation or positional relationship 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 orientation, be constructed and operate in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0054] It is also worth noting that the artificial valve in the present invention has a gripping state (also called a contracted state) suitable for the delivery or deployment process, and also has an expanded state in a free state or after deployment is completed. Unless otherwise specified, the structural description below is made in the expanded state.

[0055] The present invention provides an artificial valve capable of bidirectional loading, which is used to replace a diseased native heart valve and replace the native heart valve to control the direction of blood flow.

[0056] like Figure 1 As shown, in one embodiment, a bidirectionally loadable artificial valve 100 includes a valve frame 1, a membrane 3 covering the valve frame 1, at least two artificial valve leaflets 5 that can open and close relative to each other, and a plurality of loading rods 7.

[0057] Combination Figure 2 and Figure 3, wherein the valve frame 1 is an expandable cylindrical frame member that supports the artificial valve leaflet 5. The valve frame 1 can be radially compressed to a gripped state or a compressed state to be delivered to a preset deployment site, and the valve frame 1 can also expand or swell to a functional size in the deployed state at the deployment site. Preferably, the valve frame 1 is made of a metal with shape memory function such as nickel-titanium alloy, so that the valve frame 1 has self-expansion properties and can self-expand. The overall axial height of the valve frame 1 is usually not less than 15 mm, and the diameter is usually not less than 20 mm. The appropriate size specification can be selected according to the actual situation of the native heart valve to be replaced.

[0058] The artificial valve leaf 5 can be made of any suitable biological material (e.g., pericardial tissue, such as bovine or porcine pericardium), biocompatible synthetic material or other such material. The artificial valve leaf 5 can be fixedly connected to the valve frame 1 and / or the membrane 3 by sutures. The free ends E of each artificial valve leaf 5 not fixed by sutures can be relatively opened and closed to allow or prevent blood from flowing through.

[0059] The membrane 3 may be made of a biocompatible, flexible, compressible material, such as poly-PTFE fabric, PET fabric, pericardial tissue, etc. The membrane 3 may be fixed to the radial inner surface and / or radial outer surface of the valve frame 1 by sutures to cover the valve frame 1 and form a blood flow channel.

[0060] Specifically, in the axial direction, the end of the valve frame 1 close to the free end E of the artificial valve leaflet 5 is the first end 11 of the valve frame 1, and the end opposite to the first end 11 or the end of the valve frame 1 away from the free end E of the artificial valve leaflet is the second end 13 of the valve frame 1. Between the first end 11 and the second end 13, the valve frame 1 includes a plurality of rows of interconnected grids, wherein the plurality of rows may be 2 rows, 3 rows, 4 rows, 5 rows or even more. Each grid is formed by connecting and surrounding a plurality of struts. The shape of the grid can be Figure 1-Figure 3 The rhombus formed by four supporting rods shown in the figure may also be a hexagon or other shapes. Figure 1-Figure 3 As shown in the example, the valve frame 1 includes 3 rows of grids, wherein the first row of grids G1 is the grid where the first end 11 is located, the third row of grids is the grid where the second end 13 is located, and the second row of grids G2 is located between the first row of grids and the third row of grids, that is, the second row of grids G2 is located in the axial middle of the valve frame 1.

[0061] See also Figure 1-Figure 7In this embodiment, the plurality of loading rods 7 include a plurality of first loading rods 71 ​​and a plurality of second loading rods 73, wherein the first loading rod 71 can be rotatably connected to a node of the first row of grids G1 (i.e., the grid where the first end 11 of the valve frame 1 is located), and the second loading rod 73 can be rotatably connected to a node of the third row of grids G3 (i.e., the grid where the second end 13 of the valve frame 1 is located), and the node is the part where two adjacent rods of the grid are connected. According to the use requirements, the operator can selectively rotate the first loading rod 71 to make it axially protrude from the first end 11 of the valve frame 1, and then use the first loading rod 71 to connect with the conveying device, and the first loading rod 71 is loaded by the conveying device; or rotate the second loading rod 73 to make it axially protrude from the second end 13 of the valve frame 1, and then use the second loading rod 73 to connect with the conveying device, and the second loading rod 73 is loaded by the conveying device. Both the first loading rod 71 and the second loading rod 73 can be made of 316LVM stainless steel, cobalt-chromium alloy, nickel-titanium alloy and other materials by machining.

[0062] Preferably, the first loading rod 71 is rotatably connected to the upper node D1 of the first row of grid G1 (according to Figure 2 , Figure 3 As shown in the orientation, the upper node D1 is a component of the first end 11 of the valve frame 1. Of course, the first loading rod 71 can also be selectively connected to other nodes (left node, right node, lower node) of the first row grid G1, but selecting the upper node D1 helps to reduce the length of the first loading rod 71. When the first loading rod 71 is rotated into place, all parts of the first loading rod 71 protrude axially from the first end 11 of the valve frame 1; when other nodes are selected, when the first loading rod 71 is rotated into place, only a partial length of the first loading rod 71 can protrude axially from the first end 11 of the valve frame 1.

[0063] The number of the first loading rods 71 ​​may be 3 or more, and the first loading rods 71 ​​may be arranged uniformly or non-uniformly in the circumferential direction at the first end 11 of the valve frame 1, and at least one grid G1 may be spaced between two adjacent first loading rods 71, or the upper node D1 of each grid G1 is respectively connected to a first loading rod 71. The axial lengths of the first loading rods 71 ​​may be consistent or staggered, which is not limited here. The number of the second loading rods 73 may be 3 or more, and the second loading rods 73 may be arranged uniformly or non-uniformly in the circumferential direction at the second end 13 of the valve frame 1, and at least one grid G3 may be spaced between two adjacent second loading rods 73, or the lower node D3 of each grid G3 is respectively connected to a second loading rod 73. The axial lengths of the second loading rods 73 may be consistent or staggered, which is not limited here. The first loading rod 71 and the second loading rod 73 may be aligned or staggered in the circumferential direction, which is not limited here.

[0064] Specifically, in this embodiment, the first loading rod 71 is disposed radially outside the first row of grids G1, so as to facilitate the operation of rotating the first loading rod 71 relative to the valve frame 1. The first loading rod 71 includes: Figure 5 The rod body 711, the connecting portion 713 provided at one end of the rod body 711, and the loading portion 715 provided at the other end of the rod body 711 are shown. The connecting portion 713 is used to be rotatably connected to the valve frame 1, and the loading portion 715 is configured to be loaded by the valve delivery device.

[0065] Combination Figure 3-Figure 5 and Figure 7 The connecting portion 713 is provided with a first hole K1, and the node of the grid G1 such as the node D1 is provided with a second hole K2. The pin shaft 81 of a pin 8 is movable through the first hole K1 and the second hole K2 along the radial direction of the petal frame. The two ends of the pin shaft 81 are respectively fixedly connected to the anti-detachment portion 83. The radial size of the anti-detachment portion 83 is increased relative to the first hole K1 and the second hole K2, so as to prevent the first loading rod 71, the petal frame 1 and the pin 8 from detaching.

[0066] The loading portion 715 may be, but is not limited to, a semicircular protrusion, a circular hole, etc. A groove or protrusion of a matching shape is provided on the distal end of the valve delivery device to implement connection and loading.

[0067] The second loading rod 73 is arranged radially outside the third row of grids G3, so as to facilitate the operation of rotating the second loading rod 73 relative to the valve frame 1. The second loading rod 73 has the same structure as the first loading rod 71, which will not be described in detail here. The second loading rod 73 and the nodes of the grid G3 such as the following node D3 are also rotatably connected by the pin 8, which will not be described in detail here.

[0068] It can be understood that in other embodiments, the first loading rod 71 can also be rotatably connected to the upper node D1 of the grid G1 on the radial inner side of the first row of grids G1, as long as the length of the first loading rod 71 is controlled to ensure that it does not interfere with the artificial valve leaflet 5 before the first loading rod 71 rotates to axially protrude from the first end 11 of the valve frame 1. The second loading rod 73 can also be rotatably connected to the lower node D3 of the grid G3 on the radial inner side of the third row of grids G3, as long as the length of the second loading rod 73 is controlled to ensure that it does not interfere with the artificial valve leaflet 5 before the second loading rod 73 rotates to axially protrude from the second end 13 of the valve frame 1. Compared with the solution of setting the loading rod on the radial outer side of the valve frame, the solution of setting the loading rod on the radial inner side of the valve frame helps to reduce the overall crimping size of the artificial valve.

[0069] like Figure 1 , Figure 2As shown, only one of the first loading rod 71 and the second loading rod 73 needs to be used. When the loading rod is not used or the valve 100 is not loaded, the first loading rod 71 can be rotated to overlap with a rod of a grid (such as grid G1) where the first end 11 of the valve frame 1 is located, and is restrained on the rod, and the second loading rod 73 can be rotated to overlap with a rod of a grid (such as grid G3) where the second end 13 of the valve frame is located, and is restrained on the rod. When the first loading rod 71 is needed, the restraint on the first loading rod 71 is released to allow the first loading rod 71 to be rotated to axially protrude from the first end 11 of the valve frame 1, but the restraint on the second loading rod 73 is still maintained; when the second loading rod 73 is needed, the restraint on the second loading rod 73 is released to allow the second loading rod 73 to be rotated to axially protrude from the second end 13 of the valve frame 1, but the restraint on the second loading rod 73 is still maintained; this arrangement ensures that only the loading rod that is used protrudes axially from the valve frame 1, while the loading rod that is not used does not protrude axially from the valve frame 1, which helps to reduce the overall length of the artificial valve and facilitate the valve to pass through a curved path.

[0070] Specifically, the first loading rod 71 can be bound by being tied to the support rod of the grid (such as grid G1) where the first end 11 of the valve frame 1 is located through a plurality of coils 61 or cloth sleeves, and the first loading rod 71 can be released by untying or cutting the coils 61 or removing the cloth sleeves; the second loading rod 73 can be bound by being tied to the support rod of the grid (such as grid G1) where the second end 13 of the valve frame 1 is located through a plurality of coils 63 or cloth sleeves, and the second loading rod 73 can be released by untying or cutting the coils 63 or removing the cloth sleeves. Of course, other releasable binding methods can also be used.

[0071] Combination Figure 1 and Figure 3-Figure 7 As shown, in order to enable the first loading rod 71 to stop after being rotated into position, so as to maintain the position protruding axially from the first end 11 of the valve frame 1, thereby facilitating accurate release of the artificial valve, a limiting structure is further provided between the first loading rod 71 and the valve frame 1. Specifically, the limiting structure includes a first limiting hole K3 provided on the rod body 711, a second limiting hole K4 provided on the upper node D1, and a limiting pin 19. The first limiting hole K3 is located at the periphery of the first hole K1 and adjacent to the first hole K1, and the second limiting hole K4 is located at the periphery of the second hole K2 and adjacent to the second hole K2. When the first loading rod 71 is rotated into position, i.e. parallel to the axial direction of the valve frame, the first limiting hole K3 is aligned with the second limiting hole K4, and the limiting pin 19 is inserted into the first limiting hole K3 and the second limiting hole K4 to form an interference fit, i.e., the first loading rod 71 is stopped.

[0072] Similarly, in order to allow the second loading rod 73 to stop after being rotated into position, so as to maintain a position protruding axially from the second end 13 of the valve frame 1, thereby facilitating accurate release of the valve, a limiting structure identical to the above-mentioned limiting structure is also provided between the second loading rod 73 and the valve frame 1, which will not be described in detail here. When the second loading rod 73 is rotated into position, i.e. parallel to the axial direction of the valve frame, the limiting hole (not marked) provided on the rod body of the second loading rod 73 is aligned with the limiting hole (not marked) provided on the lower node D3, and the limiting pin (not marked) is inserted into the limiting hole to form an interference fit, thereby achieving the stopping of the second loading rod 73.

[0073] See also Figures 8 to 13 Compared with the prior art, the artificial valve 100 of this embodiment can choose to release the restraint on the first loading rod 71, rotate the first loading rod 71 to axially protrude from the first end 11 of the valve frame 1 and be loaded by the valve delivery device, or release the restraint on the second loading rod 73, rotate the second loading rod 73 to axially protrude from the second end 13 of the valve frame 1 and be loaded by the valve delivery device.

[0074] For the same native diseased valve, the artificial valve 100 can be connected and loaded on the valve delivery device using the first loading rod 71, and can be applied to one of the transcatheter or transapical intervention methods, or can be connected and loaded on the valve delivery device using the second loading rod 73, and can be applied to the other of the transcatheter or transapical intervention methods. For example, for the native aortic valve, the artificial valve 100 can be connected and loaded on the valve delivery device 91 using the first loading rod 71, and can be applied to the transcatheter intervention path to replace the native aortic valve AV (refer to Figure 8 As shown, the free end E of the artificial valve leaflet 5 faces upward, and the specific intervention path can be the femoral artery-aortic arch); the second loading rod 73 can also be connected and loaded on the valve delivery device 91, and the native aortic valve AV can be replaced by a transapical intervention path (refer to Fig. 9 As shown, the free end E of the artificial valve leaflet 5 faces upward). For another example, for a native mitral valve or a native tricuspid valve, the artificial valve 100 can be connected and loaded on the valve delivery device 91 using the second loading rod 73, and is suitable for replacing the native mitral valve MV through a transcatheter interventional approach (refer to Fig.10 As shown, the free end E of the artificial valve leaflet 5 faces downward, and the specific intervention path can be femoral vein-inferior vena cava-right atrium-left atrium-left ventricle) or native tricuspid valve TV (refer to Fig.12 As shown, the free end E of the artificial valve leaflet 5 faces downward, and the specific intervention path can be jugular vein-superior vena cava-right atrium); the first loading rod 71 can also be connected and loaded on the valve delivery device, and the native mitral valve MV can be replaced by a transapical intervention path (refer to Fig.11 As shown, the free end E of the artificial valve leaflet 5 is facing downward) or the native tricuspid valve TV (refer to Fig.13 As shown, the free end E of the artificial valve leaflet 5 faces downward).

[0075] It is worth noting that the artificial valve 100 can be deployed alone or in combination with the docking device 93 (especially for replacing the native mitral valve or native tricuspid valve), and the artificial valve 100 is released in the inner cavity of the docking device 93. The docking device 93 can be an artificial valve ring or artificial valve that has been implanted a long time ago; it can also be a specially set docking device 93, which is implanted first, and the artificial valve 100 is delivered and released in the docking device 93 immediately thereafter.

[0076] For the same type of transcatheter intervention, the artificial valve 100 can be connected and loaded on the valve delivery device 91 using the first loading rod 71, and deployed alone in the first orientation to replace the native aortic valve AV (see Figure 8 As shown, the free end E of the artificial valve leaflet 5 faces upward, and the specific intervention path can be the femoral artery-aortic arch); the second loading rod 73 can also be connected and loaded on the valve delivery device 91, and can be deployed together with the docking device 93 in a second orientation inverted relative to the first orientation to replace the native atrioventricular valve, including the native mitral valve MV (refer to Fig.10 As shown, the free end E of the artificial valve leaflet 5 faces downward, and the specific intervention path can be femoral vein-inferior vena cava-right atrium-left atrium-left ventricle) or native tricuspid valve TV (refer to Fig.12 As shown, the free end E of the artificial valve leaflet 5 faces downward, and the specific intervention path can be jugular vein-superior vena cava-right atrium). For the same type of transapical intervention, the artificial valve 100 can be connected and loaded on the valve delivery device 91 using the second loading rod 73, and deployed alone in the first orientation to replace the native aortic valve AV (refer to Fig. 9 As shown, the free end E of the artificial valve leaflet 5 faces upward); the first loading rod 71 can also be connected and loaded on the valve delivery device 91, and can be deployed together with the docking device 93 in a second position inverted relative to the first position to replace the native atrioventricular valve, including the native mitral valve MV (refer to Fig.11 As shown, the free end E of the artificial valve leaflet 5 is facing downward) or the native tricuspid valve TV (refer to Fig.13 As shown, the free end E of the artificial valve leaflet 5 faces downward).

[0077] As can be seen from the above, the artificial valve 100 of this embodiment can select the corresponding first loading rod 71 or second loading rod 73 to connect with the valve delivery device according to the actual requirements of the native heart valve to be replaced and the intervention method, breaking through the limitations of the intervention method and the native valve suitable for replacement, and significantly broadening the scope of application.

[0078] See also Fig.14The difference between the bidirectionally loadable artificial valve 200 of another embodiment of the present invention and the above-mentioned embodiment mainly lies in the structural change of the loading rod 27, and the other structures and functions that are the same will not be described repeatedly.

[0079] Combination Figure 14-Figure 20 In this embodiment, the plurality of loading rods 27 are no longer distinguished between the first loading rod and the second loading rod, and the length of the loading rod 27 is increased compared to the first loading rod or the second loading rod in the above-mentioned embodiment. The loading rod 27 includes a rod body 271, a connecting portion 273 provided at one end of the rod body 271, and a loading portion 275 provided at the other end of the rod body 271, the connecting portion 273 is used to be rotatably connected to the valve frame 1, and the loading portion 275 is configured to be loaded by the valve delivery device. Specifically, the connecting portion 273 can be rotatably connected to a node (such as node D4) of a grid (such as the second row of grid G2) located in the axial middle of the valve frame 1, and the loading rod 27 can selectively rotate toward the first end 11 of the valve frame 1 until it protrudes axially from the first end 11 of the valve frame 1 (such as Fig.21 ), or rotate toward the second end 13 of the valve frame 1 until it protrudes axially from the second end 13 of the valve frame 1 (as shown in Fig.24 To ensure that the loading rod 27 can axially protrude from the first end 11 or the second end 13 of the valve frame 1, when the valve frame 1 includes three rows of grids, as shown in FIG. Fig.17 As shown, the length of the loading rod 27 / rod body 271 is at least greater than the axial length of a grid in the clamped state.

[0080] It can be understood that if the valve frame includes 4 rows of grids, the grid located in the axial middle of the valve frame 1 can be the 2nd row of grids or the 3rd row of grids; if the valve frame includes 5 rows of grids, the grid located in the axial middle of the valve frame 1 is the 3rd row of grids; and so on. The more rows of grids the valve frame has, the longer the length of the loading rod 27 / rod body 271 needs to be set, such as greater than 1.5 times, 2 times, etc., of the axial length of a grid in the gripping state, to ensure that the loading rod 27 can axially protrude from the first end 11 of the valve frame 1 after being selected to rotate toward the first end 11 of the valve frame 1, and the loading rod 27 can also axially protrude from the second end 13 of the valve frame 1 after being selected to rotate toward the second end 13 of the valve frame 1.

[0081] In this embodiment, since the loading rod 27 can be rotatably connected to the grid located in the axial middle of the valve frame 1, in order to avoid interference with the artificial valve leaflet 5, the loading rod 27 is only arranged on the radial outer side of the valve frame 1. The loading rod 27 can be made of 316LVM stainless steel, cobalt-chromium alloy, nickel-titanium alloy and other materials by machining.

[0082] like Figure 14-16 and Fig.21 and Fig. 22As shown, in this embodiment, the connection part 273 and the node D4 are also connected by a pin 8, and the pin shaft of the pin 8 is correspondingly movable through the through hole (not marked) opened on the node D4 and the through hole (not marked) opened on the connection part 273, and the two ends of the pin shaft are respectively fixedly connected to the anti-detachment part, which is used to prevent the loading rod 27, the petal frame 1 and the pin 8 from detaching. This is the same as the corresponding structure of the above embodiment, and will not be repeated here.

[0083] like Figure 18-Figure 20 and Fig.21 and Fig.23 As shown, in order to make the loading rod 27 stop after being rotated into position, so as to maintain the position protruding axially from the first end 11 of the valve frame 1, or maintain the position protruding axially from the second end 13 of the valve frame 1, so as to facilitate accurate release of the valve, a limiting structure is also provided between the loading rod 27 and the valve frame 1. Specifically, the limiting structure includes a third limiting hole K5 provided on the first end 11 of the valve frame 1 (such as the upper node D1 of the first row of grids G1), a fourth limiting hole K6 provided on the second end 13 of the valve frame 1 (such as the lower node D3 of the third row of grids G3), and a limiting protrusion 29 provided on the rod body 271 of the loading rod 27. Among them, the third limiting hole K5, the through hole opened on the node D4, and the fourth limiting hole K6 are aligned in the axial direction of the valve frame. When the loading rod 27 needs to be operated to rotate toward the first end 11 of the valve frame 1, a radially outward force can be slightly applied to the loading rod 27 to make the limiting protrusion 29 leave the outer surface of the valve frame 1 until the limiting protrusion 29 is aligned with the third limiting hole K5, the force is removed, and the limiting protrusion 29 is inserted into the third limiting hole K5, thereby achieving the parking of the loading rod 27 and keeping the loading rod 27 axially protruding from the first end 11 of the valve frame 1. When the loading rod 27 needs to be operated to rotate toward the second end 13 of the valve frame 1, a radially outward force can be slightly applied to the loading rod 27 to make the limiting protrusion 29 leave the third limiting hole K5 and / or the outer surface of the valve frame 1 until the limiting protrusion 29 is aligned with the fourth limiting hole K6, the force is removed, and the limiting protrusion 29 is inserted into the fourth limiting hole K6, thereby achieving the parking of the loading rod 27 and keeping the loading rod 27 axially protruding from the second end 13 of the valve frame 1.

[0084] For the artificial valve 200 of this embodiment, the loading rod 27 can be rotated toward the first end 11 of the valve frame 1 to axially protrude from the first end 11, and the loading portion 275 is loaded by the valve delivery device outside the first end 11, or the loading rod 27 can be rotated toward the second end 13 of the valve frame 1 to axially protrude from the second end 13, and the loading portion 275 is loaded by the valve delivery device outside the second end 13. For specific usage, please refer to Figure 8-Figure 13According to the relevant description, the artificial valve 200 of this embodiment can also choose to rotate the loading rod 27 toward the first end 11 of the valve frame 1 or rotate the loading rod 27 toward the second end 13 of the valve frame 1 and connect with the valve delivery device accordingly according to the actual requirements of the native heart valve to be replaced and the intervention method, breaking through the limitations of the intervention method and the native valve suitable for replacement, significantly broadening the scope of application, and having a simpler structure and easier operation.

[0085] See also Fig.25 A bidirectionally loadable artificial valve 300 according to another embodiment of the present invention comprises a valve frame 1, a membrane 3 covering the valve frame 1, and at least two artificial valve leaflets 5 that can open and close relative to each other, wherein the artificial valve leaflets 5 are fixedly connected to the valve frame 1 and / or the membrane 3.

[0086] Combination Fig.26 Similarly, the end of the valve frame 1 close to the free end E of the artificial valve leaflet 5 is the first end 11 of the valve frame 1, and the end opposite to the first end 11 or the end of the valve frame 1 away from the free end E of the artificial valve leaflet is the second end 13 of the valve frame 1. The valve frame 1 includes a plurality of rows of interconnected grids, wherein the plurality of rows may be 2 rows, 3 rows, 4 rows, 5 rows or even more. Taking 3 rows as an example, the first row of grids G1 is the grid where the first end 11 is located, and the third row of grids is the grid where the second end 13 is located.

[0087] The artificial valve 300 in this embodiment further includes a plurality of loading rods 37, which are different from the first loading rod 71 and the second loading rod 73 in the aforementioned embodiment which are always installed and connected to the valve frame 1, and also different from the loading rod 27 which is always installed and connected to the valve frame 1. The loading rods 37 in this embodiment are selectively installed and connected to the first end 11 or the second end 13 of the valve frame when loading is to be performed, and after the connection is completed, they can protrude axially from the first end 11 or the second end 13 of the valve frame 1. In other words, the plurality of loading rods 37 in this embodiment are separate and independent from the valve frame 1 before being connected to the valve frame 1.

[0088] like Figure 25-28As shown, in order to facilitate installation, a plurality of first docking portions 16 are provided on the first end 11 of the valve frame 1 or on each upper node D1 of the first row of grids G1, and a plurality of first docking portions 16 are also provided on the second end 13 of the valve frame 1 or on each lower node D3 of the third row of grids G3. The number of the first docking portions 16 provided on the first end 11 should be no less than the number of the loading rods 37, preferably 3 or more, and the first docking portions 16 may be adjacent or spaced in the circumferential direction. The number of the first docking portions 16 provided on the second end 13 should also be no less than the number of the loading rods 37, preferably 3 or more, and the first docking portions 16 may be adjacent or spaced in the circumferential direction. The first docking portions 16 provided at the first end 11 may be aligned or staggered with the first docking portions 16 provided at the second end 13 in the circumferential direction, and there is no limitation here.

[0089] The loading rod 37 can be made of 316LVM stainless steel, cobalt-chromium alloy, nickel-titanium alloy and other materials by machining. The loading rod 37 includes a rod body 371, a second docking portion 373 provided at one end of the rod body 371, and a loading portion 375 provided at the other end of the rod body 371. The second docking portion 373 can selectively be interlocked with the first docking portion 16 located at the first end 11 of the valve frame 1 or with the first docking portion 16 located at the second end 13 of the valve frame 1. The loading portion 375 is configured to be loaded by the valve delivery device. Specifically, the shapes of the first docking portion 16 and the second docking portion 373 are complementary and adapted to achieve interlocking, for example Figure 27-Figure 29 as well as Fig.31 The S-shaped complementary shape shown.

[0090] In order to prevent the first docking portion 16 and the second docking portion 373 from being separated after being engaged, a sleeve 39 is movably provided on the loading rod 37, and the sleeve 39 is used to wrap the mutually engaged part of the first docking portion 16 and the second docking portion 373. The sleeve 39 can be made of alloy materials such as 316LVM stainless steel by machining.

[0091] Combination Fig.25 and Figure 29-Figure 31Furthermore, the rod body 371 is provided with a holding portion 377 at a position adjacent to the second docking portion 373, and the holding portion 377 can be configured as a spring sheet capable of elastic deformation. In a natural state, the holding portion 377, i.e., the spring sheet, rises outward from the rod body 371 and extends toward the second docking portion 373, and the free end of the holding portion 377, i.e., the spring sheet, is close to the second docking portion 373. Before and during the engagement of the first docking portion 16 and the second docking portion 373, the sleeve 39 is movably sleeved on the rod body 371 between the loading portion 375 and the holding portion 377. After the first docking portion 16 and the second docking portion 373 are engaged, the operator applies force to push the sleeve 39 toward the second docking portion 373, and the clamping portion 377 is compressed and deformed by the end of the sleeve 39 close to the second docking portion 373 and enters the inner cavity of the sleeve 39 until the sleeve 39 wraps the mutually engaged portion of the first docking portion 16 and the second docking portion 373, and the clamping portion 377 is exposed from the other end of the sleeve 39 and resumes tilting, and the free end of the clamping portion 377 can clamp the end surface of the other end of the sleeve 39. In this way, the sleeve 39 is limited between the clamping portion 377 and the grid node (such as the upper node D1 of the first row of grid G1, or the lower node D3 of the third row of grid G3), thereby maintaining the engaged connection between the first docking portion 16 and the second docking portion 373.

[0092] For the artificial valve 300 of this embodiment, the operator needs to connect all the loading rods 37 to the first end 11 of the valve frame 1 in one way or connect all the loading rods 37 to the second end 13 of the valve frame 1 in one way, and then connect the loading rods 37 to the valve delivery device. For specific usage, please refer to Figure 8-Figure 13 The artificial valve 300 of this embodiment also achieves a widened scope of application.

[0093] The above description is only a preferred specific implementation manner of the present invention, and the protection scope of the present invention is not limited to the embodiments listed above. Any simple change or equivalent replacement of the technical solution that can be obviously obtained by any technician familiar with the technical field within the technical scope disclosed in the present invention falls within the protection scope of the present invention.

Claims

1. A bidirectionally loadable artificial valve, characterized in that: It comprises a valve frame, a membrane covering the valve frame, at least two artificial valve leaflets that can open and close relative to each other, and a plurality of loading rods; the artificial valve leaflets are fixedly connected to the valve frame and / or the membrane; The loading rod is rotatably connected to the valve frame and is configured to selectively protrude axially from the first end or the second end of the valve frame so as to be loaded by the valve delivery device.

2. The bidirectionally loadable artificial valve according to claim 1, characterized in that: The valve frame includes a plurality of rows of grids, and the loading rod is rotatably connected to a node of the grid located in the axial middle of the valve frame.

3. The bidirectionally loadable artificial valve according to claim 2, characterized in that: The loading rod is located radially outside the valve frame.

4. The bidirectionally loadable artificial valve according to claim 3, characterized in that: The length of the loading rod is at least greater than the axial length of the grid in the clamped state, so that the loading rod rotates toward the first end of the valve frame to axially protrude from the first end of the valve frame, or the loading rod rotates toward the second end of the valve frame to axially protrude from the second end of the valve frame.

5. The bidirectionally loadable artificial valve according to claim 1, characterized in that: The valve rack includes a plurality of rows of grids, and the plurality of loading rods include a plurality of first loading rods and a plurality of second loading rods, wherein the first loading rod can be rotatably connected to a node of the grid where the first end of the valve rack is located, and the second loading rod can be rotatably connected to a node of the grid where the second end of the valve rack is located.

6. The bidirectionally loadable artificial valve according to claim 5, characterized in that: The first loading rod is located at the radially outer side or the radially inner side of the valve frame; the second loading rod is located at the radially outer side or the radially inner side of the valve frame.

7. The bidirectionally loadable artificial valve according to claim 6, characterized in that: The first loading rod may be tied to a rod of the grid where the first end of the valve frame is located, and the second loading rod may be tied to a rod of the grid where the second end of the valve frame is located; Maintain the restraint on the second loading rod and release the restraint on the first loading rod to allow the first loading rod to rotate to the first end axially protruding from the valve frame; or maintain the restraint on the first loading rod and release the restraint on the second loading rod to allow the second loading rod to rotate to the second end axially protruding from the valve frame.

8. The bidirectionally loadable artificial valve according to any one of claims 1 to 7, characterized in that: The loading rod is rotatably connected to the valve frame via a pin.

9. The bidirectionally loadable artificial valve according to any one of claims 1 to 7, characterized in that: A limiting structure is provided between the valve frame and the loading rod to keep the loading rod axially protruding from the first end or the second end of the valve frame.

10. An artificial valve capable of bidirectional loading, characterized in that: It comprises a valve frame, a membrane covering the valve frame, at least two artificial valve leaflets that can open and close relative to each other, and a plurality of loading rods; the artificial valve leaflets are fixedly connected to the valve frame and / or the membrane; The loading rod is configured to be selectively connected to and axially protrude from the first end or the second end of the valve frame so as to be loaded by the valve delivery device.

11. The bidirectionally loadable artificial valve according to claim 10, characterized in that: A plurality of first docking parts are provided at the first end and the second end of the valve frame, and a second docking part is provided at the loading rod. The second docking part can selectively be interlocked with the first docking part located at the first end of the valve frame or with the first docking part located at the second end of the valve frame. A sleeve is movably provided on the loading rod, and the sleeve is used to wrap the mutually interlocking parts of the first docking part and the second docking part.

12. The bidirectionally loadable artificial valve according to claim 11, characterized in that: The loading rod is provided with a clamping portion adjacent to the second docking portion, and the clamping portion is used to clamp the sleeve to keep the sleeve wrapping the mutually embedded portion of the first docking portion and the second docking portion.

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