Bidirectionally loadable prosthetic valve

Abstract

The application provides a bidirectional loading artificial valve, which comprises a valve frame, a membrane covering the valve frame, at least two artificial valve leaves capable of being opened and closed relative to each other, and a plurality of loading rods; the artificial valve leaves are fixedly connected to the valve frame and / or the membrane; the loading rods are rotatably connected to the valve frame and are configured to be selectively axially protruded from a first end or a second end of the valve frame to be loaded by a valve delivery device; or the loading rods are configured to be selectively connected to and axially protruded from the first end or the second end of the valve frame to be loaded by the valve delivery device. The bidirectional loading artificial valve of the application breaks through the limitations in the intervention mode and the native valve suitable for replacement, and the application range is obviously widened.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and specifically to an artificial valve that can be loaded bidirectionally. Background Technology

[0002] The human heart valves include the aortic valve and atrioventricular valves, among which the atrioventricular valves include the mitral valve and tricuspid valve. These valves act as one-way valves, working in sync 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; and 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 heart disease include medication and surgical procedures when indicated. Medication has limited effectiveness, while surgery typically requires open-chest surgery, which is highly invasive, necessitates cardiopulmonary bypass, and carries a high risk of complications and infection.

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

[0005] Minimally invasive interventional methods for prosthetic valves include transcatheter and transapical approaches. Furthermore, the free ends of the leaflets of an atrioventricular valve are oriented in the opposite direction to those of an aortic valve. Existing prosthetic valves have a single loading point for connection to the delivery system, thus limiting the types of interventions and suitable replacement native valves: for the same native valve, transcatheter prosthetic valves are not suitable for transapical delivery, and vice versa; for the same transcatheter or transapical approach, atrioventricular valves cannot be used for aortic valve replacement, and vice versa. Summary of the Invention

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

[0007] The present invention provides an artificial valve comprising a valve frame, a membrane covering the valve frame, at least two artificial valve leaflets that can be opened and closed 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 rotatably connected to the valve frame and are configured to selectively protrude axially from a first end or a second end of the valve frame for loading by a valve delivery device.

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

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

[0010] Preferably, the length of the loading rod is at least greater than the axial length of the mesh in the gripped state, such that the loading rod rotates toward the first end of the petal frame to axially protrude beyond the first end of the petal frame, or the loading rod rotates toward the second end of the petal frame to axially protrude beyond the second end of the petal frame.

[0011] In some embodiments, the petal frame includes a plurality of rows of grids, and the plurality of loading rods includes a plurality of first loading rods and a plurality of second loading rods, wherein the first loading rods are rotatably connected to the nodes of the grid where the first end of the petal frame is located, and the second loading rods are rotatably connected to the nodes of the grid where the second end of the petal frame is located.

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

[0013] Preferably, the first loading rod can be secured to a support rod of the grid at the first end of the petal frame, and the second loading rod can be secured to a support rod of the grid at the second end of the petal frame; the second loading rod is secured while the first loading rod is released to allow the first loading rod to rotate axially protrude from the first end of the petal frame; or the first loading rod is secured while the second loading rod is released to allow the second loading rod to rotate axially protrude from the second end of the petal frame.

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

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

[0016] Another type of 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 be opened and closed 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 a first end or a second end of the valve frame for loading by a valve delivery device.

[0017] In some embodiments, the first end and the second end of the petal frame are each provided with a plurality of first docking portions, and the loading rod is provided with a second docking portion. The second docking portion can selectively engage with the first docking portion located at the first end of the petal frame or with the first docking portion located at the second end of the petal frame. A sleeve is movably sleeved on the loading rod, and the sleeve is used to wrap the part where the first docking portion and the second docking portion engage with each other.

[0018] Preferably, the loading rod is provided with a retaining part adjacent to the second docking part, the retaining part being used to engage the sleeve to keep the sleeve covering the portion where the first docking part and the second docking part are mutually fitted.

[0019] The artificial valve provided by this invention can be bidirectionally loaded using any of the above technical solutions. For the same primary diseased valve, the bidirectionally loadable artificial valve can be connected to and loaded onto a valve delivery device using a loading rod protruding from the first end of the valve frame, suitable for either transcatheter or transapical intervention. Alternatively, it can be connected to and loaded onto a valve delivery device using a loading rod protruding from the second end of the valve frame, suitable for either transcatheter or transapical intervention. For the same transcatheter or transapical intervention, the bidirectionally loadable artificial valve can be connected to and loaded onto a valve delivery device using a loading rod axially protruding from either the first or second end of the valve frame, deployed in a first orientation to replace the primary aortic valve; or it can be connected to and loaded onto a valve delivery device using a loading rod axially protruding from the corresponding other end of the valve frame, deployed in a second orientation inverted from the first orientation to replace the primary atrioventricular valve. Compared with the prior art, the bidirectionally loadable artificial valve of this invention overcomes the limitations in intervention methods and suitable primary valves for replacement, significantly broadening its applicability. Attached Figure Description

[0020] Figure 1 This is a three-dimensional structural schematic diagram 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 and second loading rods are both bound to the petal frame;

[0022] Figure 3 for Figure 1 A schematic diagram of the midlobe articulation system;

[0023] Figure 4 for Figure 3 Enlarged view of point B in the middle;

[0024] Figure 5 for Figure 1 A schematic diagram of the structure of the first loading rod in the middle;

[0025] Figure 6 for Figure 1 Enlarged view of point A in the middle;

[0026] Figure 7 for Figure 6 A longitudinal cross-sectional view of the area shown;

[0027] Figure 8 for Figure 1 The diagram shows a transcatheter interventional replacement of the native aortic valve with an artificial valve.

[0028] Figure 9 for Figure 1 The diagram shows a transapical interventional replacement of the native aortic valve with an artificial valve.

[0029] Figure 10 for Figure 1 The diagram shows a diagnostic replacement of the native mitral valve with an artificial valve via a catheter-based intervention.

[0030] Figure 11 for Figure 1 The diagram shows an artificial valve replacing the native mitral valve via a transapical intervention.

[0031] Figure 12 for Figure 1 The diagram shows a transcatheter interventional replacement of the native tricuspid valve with an artificial valve.

[0032] Figure 13 for Figure 1 The diagram shows an artificial valve replacing the native tricuspid valve via a transapical intervention.

[0033] Figure 14 This is a three-dimensional structural schematic diagram of a bidirectionally loadable artificial valve according to another embodiment of the present invention;

[0034] Figure 15 for Figure 14 A schematic diagram showing the loading rod being rotated to axially protrude from the first end of the petiole frame;

[0035] Figure 16 for Figure 15 Enlarged view of point C in the middle;

[0036] Figure 17 for Figure 15 A schematic diagram of the petal frame and loading rod in the gripping state;

[0037] Figure 18 for Figure 15 A schematic diagram of the midlobe structure;

[0038] Figure 19 for Figure 15A schematic diagram of the loading rod in the middle from one perspective;

[0039] Figure 20 for Figure 15 A structural schematic diagram of the loading rod from another perspective;

[0040] Figure 21 for Figure 14 The diagram shows a cross-sectional view of the artificial valve with the loading rod protruding axially from the first end of the valve frame.

[0041] Figure 22 for Figure 21 Enlarged view of point F in the middle;

[0042] Figure 23 for Figure 21 Enlarged view of point H in the middle;

[0043] Figure 24 for Figure 14 The diagram shows a cross-sectional view of the artificial valve with the loading rod protruding axially from the second end of the valve frame.

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

[0045] Figure 26 for Figure 25 A three-dimensional structural diagram of the midlobe articulation.

[0046] Figure 27 for Figure 26 Enlarged view of point N;

[0047] Figure 28 for Figure 26 Enlarged view of point R in the middle;

[0048] Figure 29 for Figure 25 Schematic diagram of the loading rod and sleeve;

[0049] Figure 30 for Figure 25 Enlarged view of point M in the middle;

[0050] Figure 31 for Figure 30 A perspective view of the area shown. Detailed Implementation

[0051] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Furthermore, 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, it should be noted that in this article, "proximal" refers to the end of the device or component closer to the operator, and "distal" refers to the end of the device or component farther from the operator; "inflow end" refers to the end located upstream of the blood flow, and "outflow end" refers to the end located downstream of the blood flow; "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, "superior" and "inferior" are distinguished in the axial direction according to the actual placement orientation or the orientation shown in the diagram.

[0053] It is worth noting that the terms indicating orientation or positional relationship mentioned above are only for the convenience of describing the present invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as limiting the present invention.

[0054] It is also worth noting that the artificial valve in this invention has a gripped state (also known as a contracted state) suitable for delivery or deployment, as well as a free state or an expanded state after deployment. Unless otherwise specified, the structural description below is made in the expanded state.

[0055] This invention provides a bidirectionally loadable artificial valve for replacing diseased native heart valves and controlling blood flow direction in place of the native heart valves.

[0056] like Figure 1 As shown, in one embodiment, the bidirectionally loadable artificial valve 100 includes a valve frame 1, a membrane 3 covering the valve frame 1, at least two openable and closable artificial valve leaflets 5, and several loading rods 7.

[0057] Combination Figure 2 and Figure 3The valve frame 1 is an expandable cylindrical frame component that supports the artificial valve leaflet 5. The valve frame 1 can be radially compressed to a crimped or compressed state for delivery to a predetermined deployment site. The valve frame 1 can also expand or inflate at the deployment site to its functional dimensions as in its deployed state. Preferably, the valve frame 1 is made of a shape-memory metal such as a nickel-titanium alloy, thus giving it self-expanding and self-renewing properties. The overall axial height of the valve frame 1 is typically not less than 15 mm, and the diameter is typically not less than 20 mm; appropriate sizes can be selected based on the actual condition of the native heart valve to be replaced.

[0058] The artificial leaflet 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 materials. The artificial leaflet 5 can be fixedly attached to the valve frame 1 and / or the membrane 3 by sutures. The free ends E of each artificial leaflet 5 that are not fixed by sutures can open and close relative to each other to allow or prevent blood flow.

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

[0060] Specifically, in the axial direction, the end of the petiole frame 1 closest to the free end E of the artificial leaflet 5 is the first end 11 of the petiole frame 1, and the end opposite to the first end 11, or the end of the petiole frame 1 furthest from the free end E of the artificial leaflet, is the second end 13 of the petiole frame 1. Between the first end 11 and the second end 13, the petiole frame 1 includes several rows of interconnected grids, where the number of rows can be 2, 3, 4, 5, or even more. Each grid is formed by several support rods connected and enclosed. The shape of the grid can be... Figures 1-3 The rhombus shown, formed by four supporting rods, can also be hexagonal or other shapes. Figures 1-3 As shown in the example, the petal frame 1 includes 3 rows of grids, where the first row of grids G1 is the grid where the first end 11 is located, the third row of grids G2 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 petal frame 1.

[0061] Please see Figures 1-7In this embodiment, the loading rods 7 include several first loading rods 71 ​​and several second loading rods 73. The first loading rods 71 ​​are rotatably connected to nodes in the first row of grid G1 (i.e., the grid where the first end 11 of the petal frame 1 is located), and the second loading rods 73 are rotatably connected to nodes in the third row of grid G3 (i.e., the grid where the second end 13 of the petal frame 1 is located). Nodes are the points where adjacent rods of the grid connect. Depending on the usage requirements, the operator can selectively rotate the first loading rods 71 ​​so that they axially protrude beyond the first end 11 of the petal frame 1, thereby connecting the first loading rods 71 ​​to the conveying device and being loaded by the conveying device; or rotate the second loading rods 73 so that they axially protrude beyond the second end 13 of the petal frame 1, thereby connecting the second loading rods 73 to the conveying device and being loaded by the conveying device. Both the first loading rods 71 ​​and the second loading rods 73 can be made of materials such as 316LVM stainless steel, cobalt-chromium alloy, or nickel-titanium alloy through 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 petal frame 1. Of course, the first loading rod 71 can also be optionally connected to other nodes (left node, right node, lower node) of the first row of grid G1. However, 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 petal frame 1. When other nodes are selected, when the first loading rod 71 is rotated into place, only a part of the length of the first loading rod 71 can protrude axially from the first end 11 of the petal frame 1.

[0063] The number of first loading rods 71 ​​can be three or more. These first loading rods 71 ​​can be evenly or non-evenly arranged circumferentially at the first end 11 of the petal frame 1. There can be at least one grid G1 between adjacent first loading rods 71, or each grid G1's upper node D1 can be connected to a first loading rod 71. The axial lengths of the first loading rods 71 ​​can be consistent or staggered, without limitation. The number of second loading rods 73 can be three or more. These second loading rods 73 can be evenly or non-evenly arranged circumferentially at the second end 13 of the petal frame 1. There can be at least one grid G3 between adjacent second loading rods 73, or each grid G3's lower node D3 can be connected to a second loading rod 73. The axial lengths of the second loading rods 73 can be consistent or staggered, without limitation. The first loading rods 71 ​​and second loading rods 73 can be aligned or staggered circumferentially, without limitation.

[0064] Specifically, in this embodiment, the first loading rod 71 is disposed radially outside the first row of grid G1, facilitating the rotation of the first loading rod 71 relative to the petal holder 1. The first loading rod 71 includes, as follows: Figure 5 The rod 711 shown, the connecting part 713 provided at one end of the rod 711, and the loading part 715 provided at the other end of the rod 711 are shown. The connecting part 713 is rotatably connected to the valve frame 1, and the loading part 715 is configured to be loaded by the valve delivery device.

[0065] Combination Figures 3-5 and Figure 7 The connecting part 713 has a first hole K1, and the nodes of the grid G1, such as the above node D1, have a second hole K2. The pin 81 of a pin 8 moves radially through the first hole K1 and the second hole K2. The two ends of the pin 81 are respectively fixedly connected to the anti-detachment part 83. The radial dimension of the anti-detachment part 83 is increased relative to the first hole K1 and the second hole K2 to prevent the first loading rod 71, the petal frame 1 and the pin 8 from detaching.

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

[0067] The second loading rod 73 is located radially outside the third row of grid G3, facilitating its rotation relative to the petal frame 1. The second loading rod 73 has the same structure as the first loading rod 71, and will not be described further here. The node of the second loading rod 73 to grid G3 is rotatably connected via pin 8, as shown in node D3 below, and will also not be described further here.

[0068] Understandably, in other embodiments, the first loading rod 71 can also be rotatably connected to the upper node D1 of the first row of grid G1 radially inward, as long as the length of the first loading rod 71 is controlled to ensure that it does not interfere with the artificial leaflet 5 before it rotates to the point where it protrudes axially from the first end 11 of the valve frame 1. Similarly, the second loading rod 73 can also be rotatably connected to the lower node D3 of the third row of grid G3 radially inward, as long as the length of the second loading rod 73 is controlled to ensure that it does not interfere with the artificial leaflet 5 before it rotates to the point where it protrudes axially from the second end 13 of the valve frame 1. Compared to placing the loading rod radially inward of the valve frame, placing it radially outward helps reduce the overall compression 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 coincide with a rod of the grid (such as grid G1) where the first end 11 of the valve frame 1 is located, and is bound to that rod. The second loading rod 73 can be rotated to coincide with a rod of the grid (such as grid G3) where the second end 13 of the valve frame is located, and is bound to that 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 rods used axially protrude from the valve frame 1, while the unused loading rods do not axially protrude from the valve frame 1, which helps to reduce the overall length of the artificial valve and facilitates the valve's passage through a curved path.

[0070] Specifically, the first loading rod 71 can be secured to the support rod of the grid (such as grid G1) where the first end 11 of the petal frame 1 is located by several coils 61 or cloth sleeves. The first loading rod 71 can be released by untying or cutting the coils 61 or removing the cloth sleeve. Similarly, the second loading rod 73 can be secured to the support rod of the grid (such as grid G1) where the second end 13 of the petal frame 1 is located by several coils 63 or cloth sleeves. The second loading rod 73 can be released by untying or cutting the coils 63 or removing the cloth sleeve. Of course, other releasable securing methods can also be used.

[0071] Combination Figure 1 and Figures 3-7 As shown, in order to ensure that the first loading rod 71 can stop after rotating into position and remain in the position of protruding axially from the first end 11 of the valve frame 1, thereby facilitating the accurate release of the artificial valve, a limiting structure is also provided between the first loading rod 71 and the valve frame 1. Specifically, the limiting structure includes a first limiting hole K3 opened on the rod body 711, a second limiting hole K4 opened on the upper node D1, and a limiting pin 19. Among them, the first limiting hole K3 is located outside and adjacent to the first hole K1, and the second limiting hole K4 is located outside and adjacent to the second hole K2. When the first loading rod 71 rotates into position, that is, parallel to the valve frame axial direction, the first limiting hole K3 and the second limiting hole K4 are aligned, and the limiting pin 19 is inserted into the first limiting hole K3 and the second limiting hole K4 to form an interference fit, thereby stopping the first loading rod 71.

[0072] Similarly, in order to ensure that the second loading rod 73 can stop after rotating into position and remain in the position of 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 aforementioned limiting structure is also provided between the second loading rod 73 and the valve frame 1, which will not be described again here. When the second loading rod 73 rotates into position, i.e., parallel to the valve frame axis, the limiting hole (not shown) on the rod body of the second loading rod 73 aligns with the limiting hole (not shown) on the lower node D3, and the limiting pin (not shown) is inserted into the limiting hole to form an interference fit, thereby stopping the second loading rod 73.

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

[0074] For the same original diseased valve, the artificial valve 100 can be connected to and loaded onto the valve delivery device using the first loading rod 71, suitable for either transcatheter or transapical interventional methods. Alternatively, it can be connected to and loaded onto the valve delivery device using the second loading rod 73, suitable for either transcatheter or transapical interventional methods. For example, for the original aortic valve, the artificial valve 100 can be connected to and loaded onto the valve delivery device 91 using the first loading rod 71, suitable for transcatheter interventional approaches to replace the original aortic valve AV (refer to...). Figure 8 As shown, the free end E of the artificial valve leaflet 5 faces upwards. The specific interventional path can be the femoral artery-aortic arch; alternatively, the second loading rod 73 can be connected to and loaded onto the valve delivery device 91, suitable for transapical interventional approaches to replace the native aortic valve AV (see reference). Figure 9 As shown, the free end E of the artificial leaflet 5 faces upward. For example, for a native mitral or tricuspid valve, the artificial valve 100 can be connected to and loaded onto the valve delivery device 91 using the second loading rod 73, suitable for transcatheter interventional approaches to replace the native mitral valve MV (see reference). Figure 10 As shown, the free end E of the artificial valve leaflet 5 faces downwards. The specific interventional route can be femoral vein-inferior vena cava-right atrium-left atrium-left ventricle or the native tricuspid valve TV (refer to...). Figure 12 As shown, the free end E of the artificial valve leaflet 5 faces downwards. The specific interventional route can be jugular vein-superior vena cava-right atrium; alternatively, the first loading rod 71 can be connected to and loaded onto the valve delivery device, suitable for transapical interventional routes to replace the native mitral valve MV (see reference). Figure 11 As shown, the free end E of the artificial leaflet 5 faces downwards) or the native tricuspid valve TV (refer to...).Figure 13 As shown, the free end E of the artificial leaflet 5 faces downwards.

[0075] It is worth noting that the artificial valve 100 can be deployed alone or in conjunction with the docking device 93 (especially when replacing the native mitral or tricuspid valve). The artificial valve 100 is released into the lumen of the docking device 93. The docking device 93 can be an artificial valve annulus or artificial valve that has been implanted a long time ago; or it can be a specially designed docking device 93, which is implanted first, and the artificial valve 100 is then delivered and released into the docking device 93.

[0076] For the same transcatheter interventional method, the artificial valve 100 can be connected to and loaded onto the valve delivery device 91 using the first loading rod 71, and deployed independently in a first position to replace the native aortic valve AV (refer to...). Figure 8 As shown, the free end E of the artificial valve leaflet 5 faces upwards, and the specific interventional path can be the femoral artery-aortic arch; alternatively, a second loading rod 73 can be used to connect to and load onto the valve delivery device 91, in a second position inverted from the first position, and can be deployed together with the docking device 93 to replace the native atrioventricular valve, including the native mitral valve MV (see reference). Figure 10 As shown, the free end E of the artificial valve leaflet 5 faces downwards. The specific interventional route can be femoral vein-inferior vena cava-right atrium-left atrium-left ventricle or the native tricuspid valve TV (refer to...). Figure 12 As shown, the free end E of the artificial valve leaflet 5 faces downwards, and the specific interventional route can be jugular vein-superior vena cava-right atrium. For the same interventional method via the transapical approach, the artificial valve 100 can be connected to and loaded onto the valve delivery device 91 using the second loading rod 73, and deployed independently in the first position to replace the native aortic valve AV (see reference). Figure 9 As shown, the free end E of the artificial leaflet 5 faces upwards; it can also be connected to and loaded onto the valve delivery device 91 using the first loading rod 71, in a second position inverted from the first position, and deployed together with the docking device 93 to replace the original atrioventricular valve, including the original mitral valve MV (see reference). Figure 11 As shown, the free end E of the artificial leaflet 5 faces downwards) or the native tricuspid valve TV (refer to...). Figure 13 As shown, the free end E of the artificial leaflet 5 faces downwards.

[0077] As can be seen from the above, the artificial valve 100 of this embodiment can be connected to the valve delivery device by selecting the corresponding first loading rod 71 or second loading rod 73 according to the actual requirements of the original heart valve to be replaced and the intervention method, which breaks through the limitations in terms of intervention method and suitable original valve for replacement, and significantly broadens the scope of application.

[0078] Please see Figure 14The main difference between the bidirectional loading artificial valve 200 of another embodiment of the present invention and the above embodiment lies in the structural change of the loading rod 27. Other structural and functional similarities will not be described again.

[0079] Combination Figures 14-20 In this embodiment, the multiple loading rods 27 are no longer distinguished as first loading rods and second loading rods, and the length of the loading rods 27 is increased compared to the first or second loading rods in the above embodiments. The loading rod 27 includes a rod body 271, a connecting portion 273 at one end of the rod body 271, and a loading portion 275 at the other end of the rod body 271. The connecting portion 273 is 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 is rotatably connected to a node (e.g., node D4) of a grid (e.g., the second row of grid G2) located in the axial middle of the valve frame 1. The loading rod 27 can selectively rotate toward the first end 11 of the valve frame 1 until it axially protrudes beyond the first end 11 of the valve frame 1 (e.g., node D4). Figure 21 (as shown), or rotate toward the second end 13 of the valve frame 1 until it axially protrudes beyond the second end 13 of the valve frame 1 (as shown). Figure 24 (As shown). To ensure that the loading rod 27 can protrude axially from the first end 11 or the second end 13 of the petal frame 1, in the case where the petal frame 1 includes 3 rows of grids, such as Figure 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 gripping state.

[0080] Understandably, if the petal frame includes 4 rows of grids, then the grid located in the axial middle of the petal frame 1 can be the 2nd or 3rd row of grids; if the petal frame includes 5 rows of grids, then the grid located in the axial middle of the petal frame 1 is the 3rd row of grids; and so on. The more rows of grids the petal frame has, the longer the length of the loading rod 27 / rod body 271 needs to be, such as more than 1.5 times or 2 times 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 petal frame 1 after being rotated towards the first end 11, and also axially protrude from the second end 13 of the petal frame 1 after being rotated towards the second end 13.

[0081] In this embodiment, since the loading rod 27 is rotatably connected to the grid located at the axial center of the petiole frame 1, to avoid interfering with the artificial petiole 5, the loading rod 27 is only located on the radially outer side of the petiole frame 1. The loading rod 27 can be made of materials such as 316LVM stainless steel, cobalt-chromium alloy, or nickel-titanium alloy by machining.

[0082] like Figures 14-16 and Figure 21 and Figure 22As shown, in this embodiment, the connecting part 273 and the node D4 are also connected by a pin 8. The pin 8's shaft passes through a through hole (not shown) on the node D4 and a through hole (not shown) in the connecting part 273. Anti-detachment parts are fixedly connected to both ends of the pin 8 to prevent the loading rod 27, the petal holder 1, and the pin 8 from separating. This is the same structure as the corresponding structure in the above embodiment, and will not be described again here.

[0083] like Figures 18-20 and Figure 21 and Figure 23 As shown, in order to ensure that the loading rod 27 can stop after rotating into position, either in the position of axially protruding from the first end 11 of the valve frame 1 or in the position of axially protruding from the second end 13 of the valve frame 1, thereby facilitating 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 on the first end 11 of the valve frame 1 (such as the upper node D1 of the first row of grid G1), a fourth limiting hole K6 on the second end 13 of the valve frame 1 (such as the lower node D3 of the third row of grid G3), and a limiting protrusion 29 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 axially with the valve frame. When it is necessary to rotate the loading rod 27 toward the first end 11 of the petal frame 1, a slight radial outward force can be applied to the loading rod 27 to make the limiting protrusion 29 leave the outer surface of the petal frame 1 until the limiting protrusion 29 is aligned with the third limiting hole K5. The force is then removed, and the limiting protrusion 29 is inserted into the third limiting hole K5, thereby stopping the loading rod 27 and keeping it axially protruding from the first end 11 of the petal frame 1. When it is necessary to rotate the loading rod 27 toward the second end 13 of the petal frame 1, a slight radial outward force can be 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 petal frame 1 until the limiting protrusion 29 is aligned with the fourth limiting hole K6. The force is then removed, and the limiting protrusion 29 is inserted into the fourth limiting hole K6, thereby stopping the loading rod 27 and keeping it axially protruding from the second end 13 of the petal frame 1.

[0084] For the artificial valve 200 in this embodiment, the loading rod 27 can be rotated toward the first end 11 of the valve frame 1 until it axially protrudes from the first end 11, and the loading part 275 is loaded onto the first end 11 by the valve delivery device; or the loading rod 27 can be rotated toward the second end 13 of the valve frame 1 until it axially protrudes from the second end 13, and the loading part 275 is loaded onto the second end 13 by the valve delivery device. For specific usage methods, please refer to... Figures 8-13According to the relevant description, the artificial valve 200 of this embodiment can also be rotated toward the first end 11 of the valve frame 1 or toward the second end 13 of the valve frame 1 according to the actual requirements of the original heart valve to be replaced and the intervention method, and connected to the valve delivery device accordingly. This breaks through the limitations in terms of intervention method and suitable original valve for replacement, significantly broadens the scope of application, and has a simpler structure and is easier to operate.

[0085] Please see Figure 25 In another embodiment of the present invention, a bidirectionally loadable artificial valve 300 includes a valve frame 1, a membrane 3 covering the valve frame 1, and at least two artificial leaflets 5 that can be opened and closed relative to each other, the artificial leaflets 5 being fixedly connected to the valve frame 1 and / or the membrane 3.

[0086] Combination Figure 26 Similarly, the free end E of the petiole frame 1 near the artificial leaflet 5 is the first end 11 of the petiole frame 1, and the end opposite to the first end 11, or the free end E of the petiole frame 1 away from the artificial leaflet, is the second end 13 of the petiole frame 1. The petiole frame 1 includes several rows of interconnected grids, which can be 2, 3, 4, 5 or more rows. 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 also includes several loading rods 37. Unlike the first loading rod 71 and the second loading rod 73 in the previous embodiment, which are always installed and connected to the valve frame 1, and also unlike 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 only when loading is to be performed, and after connection, they can protrude axially from the first end 11 or the second end 13 of the valve frame 1. That is to say, the several loading rods 37 in this embodiment are separate from the valve frame 1 and independent of each other before being connected to the valve frame 1.

[0088] like Figures 25-28As shown, for ease of installation, several first docking portions 16 are provided on the first end 11 of the petal frame 1, or on each upper node D1 of the first row of grid G1, and several first docking portions 16 are also provided on the second end 13 of the petal frame 1, or on each lower node D3 of the third row of grid G3. The number of first docking portions 16 provided on the first end 11 should be no less than the number of loading rods 37, preferably three or more, and the first docking portions 16 can be adjacent or spaced apart in the circumferential direction. The number of first docking portions 16 provided on the second end 13 should also be no less than the number of loading rods 37, preferably three or more, and the first docking portions 16 can be adjacent or spaced apart in the circumferential direction. The first docking portions 16 provided on the first end 11 can be aligned or offset from the first docking portions 16 provided on the second end 13 in the circumferential direction, which is not limited here.

[0089] The loading rod 37 can be manufactured from materials such as 316LVM stainless steel, cobalt-chromium alloy, and nickel-titanium alloy through machining. The loading rod 37 includes a rod body 371, a second docking portion 373 located at one end of the rod body 371, and a loading portion 375 located at the other end of the rod body 371. The second docking portion 373 can selectively engage 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 to achieve engagement, for example... Figures 27-29 as well as Figure 31 The S-shaped complementary shape shown.

[0090] To prevent the first docking part 16 from disengaging after it engages with the second docking part 373, a sleeve 39 is movably fitted onto the loading rod 37. The sleeve 39 is used to cover the interlocking parts of the first docking part 16 and the second docking part 373. The sleeve 39 can be made of alloy materials such as 316LVM stainless steel through machining.

[0091] Combination Figure 25 and Figures 29-31Furthermore, the rod 371 is provided with a retaining part 377 near the second docking part 373. The retaining part 377 can be configured as a spring that can elastically deform. In its natural state, the retaining part 377, i.e., the spring, extends outward from the rod 371 toward the second docking part 373, with the free end of the retaining part 377 close to the second docking part 373. Before and during the engagement of the first docking part 16 and the second docking part 373, the sleeve 39 is movably sleeved on the rod 371 between the loading part 375 and the retaining part 377. After the first mating part 16 and the second mating part 373 are engaged, the operator applies force to push the sleeve 39 towards the second mating part 373. The retaining part 377 is compressed and deformed by the end of the sleeve 39 closest to the second mating part 373, entering the inner cavity of the sleeve 39 until the sleeve 39 covers the engaged portion of the first mating part 16 and the second mating part 373. The retaining part 377 is then exposed from the other end of the sleeve 39 and returns to its raised position. The free end of the retaining part 377 can engage with the end face of the other end of the sleeve 39. Thus, the sleeve 39 is confined between the retaining part 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 mating part 16 and the second mating part 373.

[0092] For the artificial valve 300 in this embodiment, the operator needs to connect all the loading rods 37 to the first end 11 of the valve frame 1 in one of two ways, or connect all the loading rods 37 to the second end 13 of the valve frame 1 in one of two ways. The loading rods 37 are then connected to the valve delivery device. For specific usage instructions, please refer to [link / reference needed]. Figures 8-13 The relevant description is provided. The artificial valve 300 in this embodiment also expands its applicability.

[0093] The above description is only a preferred embodiment of the present invention. The scope of protection of the present invention is not limited to the embodiments listed above. Any simple changes or equivalent substitutions of the technical solutions that can be obviously obtained by those skilled in the art within the scope of the technology disclosed in the present invention shall fall within the scope of protection of the present invention.

Claims

1. An artificial valve capable of bidirectional loading, characterized in that, It 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 several 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 project axially from either the first or second end of the valve frame for loading by the valve delivery device.

2. The bidirectionally loadable artificial valve as described in claim 1, characterized in that, The petal frame includes several rows of grids, and the loading rod is rotatably connected to a node of the grid located at the axial center of the petal frame.

3. The bidirectionally loadable artificial valve as described in claim 2, characterized in that, The loading rod is located radially outside the petiole.

4. The bidirectionally loadable artificial valve as described in claim 3, characterized in that, The length of the loading rod is at least greater than the axial length of the mesh in the gripping state, such that the loading rod can be rotated toward a first end of the petal frame to axially protrude beyond the first end of the petal frame, or the loading rod can be rotated toward a second end of the petal frame to axially protrude beyond the second end of the petal frame.

5. The bidirectionally loadable artificial valve as described in claim 1, characterized in that, The petal frame includes several rows of grids, and the plurality of loading rods includes several first loading rods and several second loading rods, wherein the first loading rods are rotatably connected to the nodes of the grid where the first end of the petal frame is located, and the second loading rods are rotatably connected to the nodes of the grid where the second end of the petal frame is located.

6. The bidirectionally loadable artificial valve as described in claim 5, characterized in that, The first loading rod is located radially outside or radially inside the petiole; the second loading rod is located radially outside or radially inside the petiole.

7. The bidirectionally loadable artificial valve as described in claim 6, characterized in that, The first loading rod can be secured to a support rod of the grid at the first end of the petal frame, and the second loading rod can be secured to a support rod of the grid at the second end of the petal frame; 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 an axially protruding end of the petiole; 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 an axially protruding end of the petiole.

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

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

10. An artificial valve capable of bidirectional loading, characterized in that, It 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 several 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 and axially protrude from the first or second end of the valve frame for loading by the valve delivery device; The first and second ends of the petal frame are each provided with a plurality of first docking portions, and the loading rod is provided with a second docking portion. The second docking portion can selectively engage with the first docking portion located at the first end of the petal frame or with the first docking portion located at the second end of the petal frame. A sleeve is movably sleeved on the loading rod, and the sleeve is used to wrap the part where the first docking portion and the second docking portion engage with each other.

11. The bidirectionally loadable artificial valve as described in claim 10, characterized in that, The loading rod is provided with a retaining part adjacent to the second docking part. The retaining part is used to engage the sleeve to keep the sleeve covering the part where the first docking part and the second docking part are interlocked.

Images