Stent for a prosthetic valve

Abstract

The application provides a stent of a prosthetic valve, the stent of the prosthetic valve having opposite inflow and outflow sides, comprising: a support part surrounded by a plurality of U-shaped frames, the openings of the U-shaped frames facing the outflow side, the side edges of adjacent two U-shaped frames being adjacent to each other to form a joint column, and the side edges of the adjacent two U-shaped frames meeting at the top end of the joint column; and a ring part being a mesh structure that is radially deformable and located on the inflow side of the support part as a whole, the connection part between the ring part and the support part being at multiple positions and corresponding to the bottoms of the U-shaped frames on the inflow side respectively. The prosthetic valve prepared by using the stent of the prosthetic valve provided by the application can be implanted in the body in a surgical manner, and meanwhile, based on the partial compressibility of the prosthetic valve, the delivery performance is improved, and the surgical incision can be smaller.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a stent for an artificial valve. Background Technology

[0002] In existing technologies, artificial aortic valves can be broadly classified into transcatheter aortic valves and surgically implanted valves. Transcatheter aortic valves have very small incisions and can be implanted without stopping the heart, without cardiopulmonary bypass or general anesthesia, resulting in faster patient recovery. However, interventional valves also have limitations, including but not limited to: relying on structural anchoring, which places high demands on the patient's aortic anatomy; the need to assess the anti-displacement performance of the interventional valve due to the absence of sutures; the inability to remove the patient's original valve leaflets before implantation, which poses a risk of obstructing the coronary artery opening when the original leaflets are opened by the implanted interventional valve; the risk of paravalvular leakage in most interventional valves; and the limited number of products designed with valve-in-valve (ViV) functionality, where a new valve is deployed within a failed valve.

[0003] Surgical implantable valves include: traditional open-chest surgical valves and sutureless (minimally sutured) surgical valves. Among them, traditional open-chest surgical valves have the following advantages:

[0004] (1) The patient’s original leaflet can be removed before implantation to prevent interference with the surgical valve after implantation.

[0005] (2) The indications can basically cover all forms of valvular disease;

[0006] (3) The valve is very short, so the risk of obstructing the coronary artery opening and damaging the vascular tissue is very small;

[0007] (4) Due to the large number of sutures, there is no risk of displacement and virtually no perivalvular leakage.

[0008] Traditional open-chest surgical valves also have limitations, such as:

[0009] (1) The surgery requires cutting the sternum and aorta, which causes great damage to the patient's body. The incision is large (about 20cm), painful, and slow to recover.

[0010] (2) According to doctors’ experience, in the case of cardiopulmonary bypass and cardiac arrest, traditional surgical valves require about 90 stitches (14 positions, 6 stitches at each position), and the circulation arrest time usually takes about 1 hour. Related studies have shown that a longer circulation arrest time may lead to irreversible brain damage.

[0011] (3) Multiple sutures can damage the root of the aorta in patients;

[0012] (4) Compared with interventional valve surgery, open-heart surgery has higher requirements for the patient's age and physical condition.

[0013] Sutureless (less suture) minimally invasive small-incision surgical valve products can solve some of the problems caused by the large number of sutures in traditional open-chest surgical valve surgery, but they also have problems such as poor anchoring effect and easy to cause paravalvular leakage. Summary of the Invention

[0014] To address the issue of artificial valve implantation, a stent for artificial valves is provided, which inherits the advantages of surgical artificial valves while overcoming the problem of multiple sutures in surgical valve surgery, and has better delivery and anchoring properties.

[0015] A stent for an artificial valve, having opposing inflow and outflow sides, comprising:

[0016] The support is formed by multiple U-shaped frames, with the opening of each U-shaped frame facing the outflow side. The sides of two adjacent U-shaped frames are close to each other to form a connecting column, and the sides of two adjacent U-shaped frames meet at the top of the connecting column.

[0017] The annular portion is a radially deformable mesh structure and is located on the inflow side of the support portion. The annular portion is connected to the inflow side of the U-shaped frame.

[0018] Several alternative methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each alternative method can be combined individually with respect to the overall solution above, or multiple alternative methods can be combined with each other.

[0019] Optionally, there are multiple connection points between the annular portion and the supporting portion, each corresponding to the bottom of the U-shaped frame.

[0020] Optionally, the bracket has a relative loaded state and a released state, wherein:

[0021] In the loaded state, the outflow side of the support portion converges radially inward, and the annular portion flares outward toward the inflow side as a whole.

[0022] In the released state, the outflow side of the support expands radially outward, and the bracket as a whole has a straight cylindrical structure.

[0023] Optionally, there are three U-shaped frames, with the bottom of each U-shaped frame on the inflow side serving as a connecting end. The annular portion is fixed to each connecting end via corresponding grid structure vertices.

[0024] Optionally, the frame strength of the U-shaped frame is greater than the frame strength of the annular portion.

[0025] Optionally, the top of the connecting column is widened in the circumferential direction of the support to form a connecting lug for adaptation to the conveying system.

[0026] Optionally, the top of the connecting column is widened in the circumferential direction of the bracket to form a T-shaped structure, and the horizontal and vertical part of the T-shaped structure is the connecting ear.

[0027] Optionally, one or more connecting strips are provided between the sides of two adjacent U-shaped frames, and the connecting strips form one or more openwork windows at the joint column.

[0028] Optionally, along the axial direction of the bracket, the length of the annular portion is L1, the length of the support portion is L2, and L1 is less than L2.

[0029] Optionally, L1:L2 = 1:1.5 to 1:3.

[0030] Optionally, the grid structure of the annular portion consists of cells arranged circumferentially, with each cell forming only one circle in the axial direction.

[0031] Optionally, the total number of cells can be 9 to 24, and must be an integer multiple of the number of U-shaped boxes.

[0032] Optionally, each U-shaped frame may span 3 to 6 cells in the circumferential direction of the support.

[0033] Optionally, when the annular portion is flattened, each cell has the same axial height.

[0034] Optionally, at least one of the cells is a deformation-releasing cell open on the inflow side of the annular portion.

[0035] Optionally, apart from the deformation release cell, the remaining cells are generally rhomboid or hexagonal.

[0036] Optionally, the number of deformation release grids is the same as the number of connecting columns, and the deformation release grids and connecting columns are aligned axially with the support.

[0037] Optionally, the deformation release grid is a V-shaped frame, with the opening of the V-shape facing the inflow side of the annular portion.

[0038] Optionally, the bracket is integrally cut from a shape memory alloy.

[0039] This application also provides an implantable expandable artificial heart valve, which has an implanted state and an implanted expandable state, wherein the implanted artificial heart valve has a first size and the implanted expandable artificial heart valve has a second size, the second size being larger than the first size.

[0040] The artificial heart valve has opposing inflow and outflow sides, and the artificial heart valve includes a stent comprising:

[0041] The support is formed by multiple U-shaped frames, with the opening of each U-shaped frame facing the outflow side. The sides of two adjacent U-shaped frames are close to each other to form a connecting column, and the sides of two adjacent U-shaped frames meet at the top of the connecting column.

[0042] The annular portion is a radially deformable mesh structure and is located on the inflow side of the support portion. At least a portion of the annular portion in the circumferential direction is an expandable area.

[0043] Several alternative methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each alternative method can be combined individually with respect to the overall solution above, or multiple alternative methods can be combined with each other.

[0044] Optionally, both the first and second dimensions are the diameter of the artificial heart valve, with the second dimension being 1 to 4 mm larger than the first dimension.

[0045] Optionally, the expandable region is located on the inflow side of the annular portion.

[0046] Optionally, the expandable area is a frame structure that can extend in the circumferential direction of the support, and the frame structure is V-shaped or W-shaped.

[0047] Optionally, the position of the expandable area is aligned axially with the inflow side of the connecting column in the support.

[0048] This application also provides an artificial valve, comprising:

[0049] A stent, which forms a blood flow channel within its interior, has opposing inflow and outflow sides. The stent includes:

[0050] The support section is formed by multiple U-shaped frames, with the opening of each U-shaped frame facing the outflow side. The sides of two adjacent U-shaped frames are adjacent to each other to form a connecting column, and the sides of two adjacent U-shaped frames converge at the top of the connecting column. The annular section is a radially deformable mesh structure and is located on the inflow side of the support section. The annular section is connected to the inflow side of the U-shaped frames.

[0051] Multiple leaflets, each leaflet having a fixed edge connected to the U-shaped frame and a free edge that cooperates with other leaflets to change the degree of opening of the blood flow channel;

[0052] A film is applied to the radial inner and / or outer sides of the support.

[0053] A suture ring is fixed to the outer periphery of the bracket.

[0054] Optionally, the outer periphery of the support is surrounded by an annular anti-leakage portion, which is located on the inflow side of the suture ring.

[0055] Optionally, the suture ring extends circumferentially along the support and has a wave structure, with the portion on the inflow side being a trough and the portion on the outflow side being a crest, and the trough abutting against the anti-leakage part.

[0056] Optionally, the suture ring is located on the inflow side of the U-shaped frame, and a gap is left between it and the U-shaped frame.

[0057] Optionally, the membrane includes an outer membrane covering the radially outer side of the support, and the anti-leakage portion includes an expandable material strip and a first portion of the outer membrane, wherein the first portion wraps around the expandable material strip.

[0058] Optionally, the outer film is made of PET material.

[0059] Optionally, the suture ring includes a suture material strip and a second portion of the outer covering, wherein the second portion wraps around the suture material strip.

[0060] Optionally, the covering includes an inner covering that covers the radially inner side of the stent, the outflow side of the inner covering being abutted to the fixed edge of the leaflet, and the inner covering and the outer covering being joined together at the inflow side of the stent.

[0061] Optionally, the inner and outer membranes are an integral membrane or separate membranes.

[0062] Optionally, the expandable material strip and the stitching material strip are each independently and completely wrapped by the outer covering film, or are sandwiched between the inner covering film and the outer covering film.

[0063] Optionally, the expandable material strip is a strip of water-absorbing and expanding material that is continuously distributed around the circumference of the support, or it is a plurality of blocks arranged at intervals; the annular part has a grid structure, and the block-shaped water-absorbing and expanding material is respectively located in the hollow area of ​​the corresponding grid structure.

[0064] Optionally, the expandable material strip includes a base arranged around the periphery of the support and a water-absorbing and expandable material fixed to the base.

[0065] Optionally, the suture ring has threading marks, which are offset from the connecting posts in the circumferential direction of the support.

[0066] Optionally, the suture ring has a threading mark located at the trough of the wave.

[0067] The artificial valve provided in this application can be surgically implanted into the body. At the same time, based on the partial compressibility of the artificial valve, the delivery performance is improved, and the surgical incision can be smaller. Attached Figure Description

[0068] Figure 1a This is a schematic diagram of a stent for an artificial valve.

[0069] Figure 1b for Figure 1a Front view of the artificial valve stent shown;

[0070] Figure 1c for Figure 1a The diagram shows a stent connected to the leaflets of an artificial valve.

[0071] Figure 1d for Figure 1a The diagram shows a stent connected to the leaflets of an artificial valve.

[0072] Figure 1e This is a schematic diagram of a stent for an artificial valve.

[0073] Figure 1f This is a schematic diagram of an artificial valve;

[0074] Figure 1g for Figure 1f A schematic diagram of an artificial valve is shown.

[0075] Figure 1h This is a schematic diagram of an artificial valve;

[0076] Figure 1i for Figure 1h Exploded view of an artificial valve in China;

[0077] Figure 1j This is a schematic diagram of the anti-peripheral leakage section in an artificial valve;

[0078] Figure 1k This is a schematic diagram of the integrated structure of the anti-peripheral leakage section and the inner lining in an artificial valve.

[0079] Figure 2a This is a schematic diagram of the valve holder;

[0080] Figure 2b This is a schematic diagram of the valve holder;

[0081] Figure 2c for Figure 2b Sectional view along line AA in the middle;

[0082] Figure 2d An exploded view of the control handle in the valve holder;

[0083] Figure 2eAn exploded view of the control handle in the valve holder (another perspective);

[0084] Figure 2f This is a schematic diagram of the valve latch in the valve holder (the sleeve structure is omitted);

[0085] Figure 2g A schematic diagram showing the valve holder beginning to load the artificial valve;

[0086] Figure 2h A schematic diagram showing the complete loading of the artificial valve into the valve holder;

[0087] Figure 2i A schematic diagram showing the valve holder fully loaded with the artificial valve and the locking mechanism locked.

[0088] Figure 2j A schematic diagram of a valve holder placing an artificial valve into the native valve annulus;

[0089] Figure 2k This is a schematic diagram showing the placement of the artificial valve into the native valve annulus using a valve holder, with the suture ring fully open.

[0090] Figure 2l A schematic diagram showing the complete release of the artificial valve by the valve holder;

[0091] Figure 2m This is a schematic diagram of an artificial valve after it has been implanted in the human body.

[0092] In the diagram: 110, Support section; 111, U-shaped frame; 112, Connecting post; 113, Connecting end; 114, Connecting ear; 115, Connecting strip; 116, Openwork window; 120, Annular section; 121, V-shaped frame strip; 122, Expandable area; 130, Leaflet; 131, Free edge; 132, Fixed edge; 140, Covering membrane; 141, Inner covering membrane; 142, Outer covering membrane; 150, Suture ring; 151, Suture material tape; 160, Leakage prevention section; 161, Expandable material tape; 170, Threading mark;

[0093] 210. Control handle; 211. Housing; 212. Movable base; 213. Gear adjustment mechanism; 214. Control button; 215. Slot; 216. Elastic latch; 217. Elastic strip; 218. Guide structure; 219. Locking element; 220. Sleeve; 221. Clearance groove; 230. Valve latch; 231. Adaptor structure; 240. Transmission element; 241. Inner tube; 242. Outer tube; 250. Limiting groove. Detailed Implementation

[0094] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0095] To better describe and illustrate the embodiments of this application, reference may be made to one or more accompanying drawings, but the additional details or examples used to describe the drawings should not be considered as limiting the scope of any of the inventive creations of this application, the embodiments or preferred methods described herein.

[0096] It should be noted that when a component is said to be "connected" to another component, it can be directly connected to the other component or it can be connected to a component in between. When a component is said to be "set on" another component, it can be directly set on the other component or it may be set to a component in between.

[0097] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the specification of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application.

[0098] This application provides an artificial valve having a compressed state and an expanded state, see [link to details]. Figure 1f , Figure 1g , Figure 1h , Figure 1i As shown, it includes:

[0099] A stent, the inside of which forms a blood flow channel;

[0100] Multiple leaflets 130, each leaflet 130 having a fixed edge 132 connected to a U-shaped frame 111 and a free edge 131 that cooperates with other leaflets 130 to change the degree of opening of the blood flow channel;

[0101] The film 140 covers the inner and / or outer radial sides of the support;

[0102] The suture ring 150 is fixed to the outer periphery of the support.

[0103] The membrane 140 covers the inner and / or outer sides of the support radially.

[0104] After implantation, the suture ring 150 is used to suture with the valve ring to fix the valve position.

[0105] In some embodiments, the stent is integrally cut from a shape memory alloy tubing, such as nickel-titanium alloy. This stent can be used in transcatheter valve replacement and also in surgical valves, for example, to be fixed to the valve annulus without sutures or with minimal sutures. For example, fixing to the valve annulus with surgical sutures inherits the advantages of surgical artificial valves, such as extremely low risk of displacement, low risk of obstructing the coronary arteries, the ability to remove diseased native valve leaflets, broad indications, and the ability to achieve valve-in-valve functionality (i.e., after valve failure, a new valve can be placed within the existing valve).

[0106] The stent of the artificial valve is made of nickel-titanium alloy and can be compressed radially to 16mm, reducing the difficulty of the valve descending to the valve annulus. During implantation, the incision length on the patient's body surface can be controlled within 4-6cm to meet the stent placement requirements, which is much smaller than the 20cm incision length required for traditional surgical valve placement. This reduces the number of sutures, saves occlusion time, and reduces damage to the patient's aortic root.

[0107] In addition, the small incision allows for the use of the intercostal approach, avoiding the pain caused to the patient by cutting the sternum in the middle. Furthermore, it reduces the difficulty of implantation for patients with a small diameter at the sinus junction.

[0108] The support has a compressed state and an expanded state. See also Figure 1a , Figure 1b As shown, the support, in an expanded state, has opposing inflow and outflow sides, and includes:

[0109] The support portion 110 is formed by a plurality of U-shaped frames 111, with the opening of each U-shaped frame 111 facing the outflow side. Figure 1a (The dashed line in the middle represents the direction of blood flow). The sides of two adjacent U-shaped frames 111 are close to each other to form a connecting column 112. The sides of two adjacent U-shaped frames 111 converge at the top of the connecting column 112.

[0110] The annular portion 120 is a radially deformable mesh structure and is located on the inflow side of the support portion 110. There are multiple connection points between the annular portion 120 and the support portion 110, and they correspond to the bottom of each U-shaped frame 111 on the inflow side (in this embodiment, the turning part of the U-shape, that is, the lowest point of the U-shape).

[0111] The annular portion 120 has a deformable grid structure in the radial direction. The grid structure is a general concept and does not strictly require that each part in the circumferential direction has a complete grid.

[0112] Because the annular portion 120 has a deformable space in the radial direction, the artificial valve stent can be compressed to a certain extent in the radial direction. During the artificial valve implantation process, the artificial valve stent can be compressed. Compared with existing surgical valve replacement surgery, the valve is compressed to a great extent, which makes the surgical field wider.

[0113] See Figure 1a , Figure 1b , Figure 2h As shown, the support has a relative loaded state and a released state, wherein:

[0114] In the loaded state, the outflow side of the support 110 converges radially inward, and the annular part 120 flares outward toward the inflow side, thus compressing the bracket.

[0115] In the released state, the outflow side of the support 110 expands radially outward, and the support as a whole has a straight cylindrical structure. At this time, the support is in an expanded state and is not compressed.

[0116] Figure 1a , Figure 1b In the middle, the stent of the artificial valve is in the released state (inflated state), and the stent as a whole has a straight cylindrical structure. Figure 2h In the process, the artificial valve stent is in the loading state, the sides of the U-shaped frame 111 of the support part 110 come together to form an inwardly converging structure, and the annular part 120 is adaptively flared toward the outflow side.

[0117] In some embodiments, the stent is a one-piece structure and is made of a self-expanding, release-release shape memory material. For example, a stent is obtained by cutting a nickel-titanium alloy tube and then heat-treating it to shape it.

[0118] The stent has an expandable structure and is made of nickel-titanium. It can be anchored using the radial support force of the stent, eliminating the need for balloon dilation and reducing the complexity of the surgical procedure.

[0119] See Figure 1a , Figure 1b As shown, there are three U-shaped frames 111. The bottom of each U-shaped frame 111 on the inflow side is the connecting end 113. The annular part 120 is fixed to each connecting end 113 through the corresponding grid structure vertices.

[0120] The bottom of the inflow side, that is, the middle position of the bottom of the U-shaped frame 111, is defined as the connecting end 113, and the connecting end 113 is fixedly connected to the vertices of the grid structure of the annular part 120.

[0121] In some embodiments, the frame strength of the U-shaped frame 111 is greater than the frame strength of the annular portion 120.

[0122] The outflow side of the valve is the leaflet working area, that is, the U-shaped frame 111 serves as the most direct support when the leaflet 130 moves. The frame strength of the U-shaped frame 111 is greater than that of the frame strength of the annular portion 120. When the leaflet 130 opens and closes, the U-shaped frame 111 has higher strength and is less prone to deformation, reducing swaying and minimizing the impact on the annular portion 120, thus enhancing the durability of the stent.

[0123] During implantation, the mesh structure of the annular portion 120 primarily serves an anchoring function, anchoring itself to the annulus of the human heart valve. While ensuring the radial support force of the artificial heart valve, the frame strength of the annular portion 120 is less than that of the U-shaped frame 111. This allows the annular portion 120 to deform and adapt to external forces when subjected to pressure, reducing the impact on the U-shaped frame 111 of the support portion 110.

[0124] To achieve the difference in frame strength, the frame strip of the U-shaped frame 111 can be wider or thicker than the frame strip of the annular portion 120. Considering the convenience of processing, it is preferable that the frame strip of the U-shaped frame 111 can be wider than the frame strip of the annular portion 120.

[0125] In one embodiment, see Figure 1a , Figure 1b As shown, the top of the column 112 is widened in the circumferential direction of the support to form a connecting lug 114 for adaptation to the conveying system.

[0126] The connecting ear 114 is used to connect the artificial valve stent to the delivery system, ensuring stable installation of the stent within the system. The top of the connecting post 112 widens circumferentially to form a T-shaped structure; the horizontal and vertical portions of the T-shaped structure constitute the connecting ear 114. The connecting ear 114 can employ various structures, including... Figure 1a , Figure 1b Besides the roughly rectangular structure shown, other forms, such as a semicircle, can also be used.

[0127] In one embodiment, see Figure 1a , Figure 1b As shown, one or more connecting strips 115 are provided between the sides of two adjacent U-shaped frames 111, and the connecting strips 115 form one or more openwork windows 116 at the location of the connecting column 112.

[0128] The connecting strip 115 forms a connecting structure between the sides of two adjacent U-shaped frames 111, which strengthens the connection between the sides of the two adjacent U-shaped frames 111 on the one hand, and does not excessively interfere with the deformation of the sides of the U-shaped frames 111 on the other hand.

[0129] During the sewing process, the leaf 130 has a flange that wraps around part of the side of the U-shaped frame 111, and at least one openwork window 116 is used to accommodate the flange of the leaf 130.

[0130] In one embodiment, see Figure 1b As shown, along the axial direction of the bracket, the length of the annular portion 120 is L1, the length of the support portion 110 is L2, and L1 is less than L2.

[0131] The support portion 110 is used to fix the leaflet 130 and has at least an axial length adapted to the leaflet 130, while the annular portion 120 is used for positioning in the blood vessel and supporting the structure to prevent paravalvular leakage. Since the artificial valve is sutured to the valve annulus through a surgical procedure, the annular portion 120 can easily meet the positioning requirements and does not need to be too long axially. At the same time, supporting the structure to prevent paravalvular leakage also does not require an excessively long axial length. Therefore, while meeting the usage requirements, the axial length is minimized as much as possible to reduce adverse effects on the implantation site tissue.

[0132] In one embodiment, see Figure 1b As shown, L1:L2 = 1:1.5 to 1:3.

[0133] In one embodiment, see Figure 1a , Figure 1b As shown, at least a portion of the annular portion 120 in the circumferential direction is a V-shaped frame strip 121.

[0134] When subjected to external force, the V-shaped frame 121 is more prone to deformation and changes the angle of the V-shape. When valve-in-valve implantation is required, the presence of the V-shaped frame 121 makes it easier for the annular portion 120 to expand outward in the circumferential direction when subjected to radial external force, which is conducive to the implantation of the new valve.

[0135] When the annular portion 120 expands outward under radial force, it adapts to the external force through the V-shaped frame strip, reducing the impact on the support portion 110, that is, reducing the impact on the shape of the leaflet 130 connected to the support portion 110.

[0136] Self-expanding valves and bulbous expansion valves can be used as valve-in-valve implantation. Since the V-shaped frame 121 of the stent can expand under external force, after implantation of the self-expanding valve, the small incision valve can be opened without rebounding, ensuring that the opening area is not affected.

[0137] In one embodiment, see Figure 1a , Figure 1b As shown, the grid structure of the annular part 120 consists of cells arranged circumferentially, with each cell forming only one circle in the axial direction.

[0138] The annular portion 120 has a shorter axial dimension and only one ring of cells, reducing the density of cells. This makes the annular portion 120 more prone to deformation when subjected to radial external forces. Since the valve is implanted surgically, there is a suture between the valve and the valve annulus. The annular portion 120 is easy to deform and will not adversely affect the positioning. Moreover, it is easier to expand circumferentially when valve-in-valve implantation is required, which is conducive to the implantation of the new valve.

[0139] In one embodiment, see Figure 1a , Figure 1b As shown, the number of all cells is between 9 and 24, and is an integer multiple of the number of U-shaped boxes 111.

[0140] Each U-shaped frame spans 3 to 6 cells horizontally along the circumference of the support frame. See also Figure 1b As shown, each U-shaped frame spans 5 cells horizontally in the circumference of the support. Figure 1b In the diagram, L3 represents the projection length of half a U-shaped frame onto the circumference of the support, which corresponds to exactly 2.5 cells. Through simple calculation, we can obtain the projection length of a U-shaped frame onto the circumference of the support, which corresponds to exactly 5 cells. In other words, each U-shaped frame spans 5 cells on the circumference of the support.

[0141] All cells are evenly distributed circumferentially, or divided into at least N groups, where N is the number of U-shaped frames, and each group has the same number of frames. There are a total of 12 cells, and each cell is not strictly a completely closed circumferential structure; it can be open circumferentially.

[0142] In one embodiment, see Figure 1b As shown, in the flattened state, each cell of the annular portion 120 has the same axial height. The same axial height means that each cell has the same dimension along the support axis, and also includes that each cell is positioned in the same direction along the support axis. The vertices of the outflow sides of each cell in the annular portion 120 are coplanar, and this face is perpendicular to the axis of the support.

[0143] Only some cells of the annular portion 120 are connected to the connecting end 113 of the U-shaped frame 111, while the remaining cells are not connected to the U-shaped frame 111. The deformation between the side of the U-shaped frame 111 and the annular portion 120 is relatively independent.

[0144] In one embodiment, see Figure 1a , 1b As shown, at least one cell is a deformation release cell open on the inflow side of the annular portion 120.

[0145] V-shaped frame 121 is the deformation release grid. Under the action of radial external force, the deformation release grid deforms first to adapt to the external force, and the remaining circumferentially closed cells deform subsequently.

[0146] In one embodiment, see Figure 1a , 1b As shown, except for the deformation release cell, the other cells are roughly rhombuses or hexagons. The cells are rhombuses or hexagons, and adjacent cells are connected by their vertices.

[0147] The shape of the cell is not a strict geometric shape, and there are local deformations due to processing needs, but it should at least meet the requirements of radial contraction and expansion of the support.

[0148] In one embodiment, see Figure 1a As shown, the number and circumferential position of the deformation release grids correspond one-to-one with the connecting columns 112. The number of deformation release grids is the same as the number of connecting columns, and the deformation release grids and connecting columns are aligned axially with the support.

[0149] The deformation release grid and the connecting column 112 are in one-to-one correspondence. When subjected to external force, the circumferential expansion parts of the annular part 120 and the support part 110 are aligned with each other in the axial direction. The deformation of the annular part 120 and the support part 110 restrains each other less. That is, when the annular part 120 expands circumferentially, it will not be restrained by the support part 110, and vice versa.

[0150] In one embodiment, see Figure 1a As shown, the deformation release grid is a V-shaped frame 121, and the opening of the V-shape faces the inflow side of the annular portion 120.

[0151] The V-shaped opening faces the inflow side of the annular portion 120, and the V-shaped opening expands more easily when subjected to radial external force.

[0152] In one embodiment, see Figure 1f As shown, the outer periphery of the support is surrounded by an annular anti-leakage portion 160, which is located on the inflow side of the suture ring 150.

[0153] See Figure 1f As shown, the suture ring 150 extends circumferentially along the support and has a wave structure. The part on the inflow side is a trough, and the part on the outflow side is a crest. The trough is in contact with the anti-leakage part 160.

[0154] After valve implantation, the stent is anchored by its own expandable structure, and the suture ring 150 is sutured to the valve annulus to ensure the stability of the valve after implantation. At the same time, the anti-leakage part 160 can seal the gap between the valve annulus and the suture ring 150 to prevent blood from flowing through the gap.

[0155] In one embodiment, see Figure 1fAs shown, the suture ring 150 is located on the inflow side of the U-shaped frame 111, and there is a gap between it and the U-shaped frame 111.

[0156] The septum facilitates the sewing of the membrane 140 and the leaflet 130, and also provides the suture ring 150 with a certain deformation space. That is, when the artificial valve is compressed and enters the valve holder, the deformation of the suture ring 150 will not bring a large deformation pressure to the leaflet 130.

[0157] In one embodiment, see Figure 1f , Figure 1g , Figure 1h , Figure 1i As shown, the membrane 140 includes an outer membrane 142 and covers the outer side of the support radially. The anti-leakage part 160 includes an expandable material strip 161 and a first part of the outer membrane 142, and the first part wraps the expandable material strip 161.

[0158] In one embodiment, see Figure 1f , Figure 1g , Figure 1h , Figure 1i As shown, the suture ring 150 includes a suture material strip 151 and a second part of an outer covering 142, and the second part wraps around the suture material strip 151.

[0159] In addition to the first and second parts, the outer membrane 142 may have other parts. The outer membrane 142 is a single piece, wherein the first part wraps the expandable material strip 161 and the second part wraps the stitching material strip 151, reducing the splicing of the outer membrane 142, which facilitates processing and reduces material leakage.

[0160] The suture material 151 can be made of silicone rubber, which has moderate elasticity, reduces rigid compression on the valve annulus, and facilitates the suturing process. The artificial valve is sewn onto the valve annulus through three suture points, reducing the risk of valve displacement. The suture ring 150 can also fit well with the original valve annulus, which reduces paravalvular leakage to a certain extent.

[0161] In one embodiment, see Figure 1f , Figure 1g , Figure 1h , Figure 1i As shown, the membrane 140 includes an inner membrane 141, which covers the inner side of the stent in the radial direction. The outflow side of the inner membrane 141 is connected to the fixing edge 132 of the leaflet 130. The inner membrane 141 and the outer membrane 142 are connected to the inflow side of the stent.

[0162] The inner liner 141 and the outer liner 142 completely enclose the stent, reducing the exposed portion.

[0163] The inner membrane 141 and the outer membrane 142 are either an integral membrane or separate membranes.

[0164] The inner and outer films are made of different or the same materials.

[0165] In one embodiment, the inner film 141 is made of PU material, and the outer film is made of PET material (PET fabric).

[0166] The seams between the separate membranes are located on the inflow side of the stent, or on the outer radial side of the stent, or on the inner radial side of the stent.

[0167] In one embodiment, see Figure 1f , Figure 1g , Figure 1h , Figure 1i As shown, the expandable material strip 161 and the stitching material strip 151 are each independently and completely wrapped by the outer covering film 142, or are clamped and wrapped between the inner covering film 141 and the outer covering film 142.

[0168] See Figure 1i As shown, the suture material strip 151 extends circumferentially along the support and has a wavy structure. When the inner cover 141 and the outer cover 142 wrap the suture material strip 151, they do not change the wavy configuration of the suture material strip. Therefore, the resulting suture ring 150 also has a wavy structure consistent with the suture material strip 151. The part on the inflow side is a trough, and the part on the outflow side is a crest. The trough is close to the anti-leakage part 160.

[0169] The expandable material belt 161 can be made of PU foam. PU foam has the characteristics of good elasticity and water impermeability, which is conducive to tight fit with the valve annulus and reduces paravalvular leakage.

[0170] In one embodiment, see Figure 1f , Figure 1g , Figure 1h , Figure 1i As shown, the expandable material strip 161 includes a base arranged around the periphery of the support and a water-absorbing and expandable material fixed to the base.

[0171] The substrate and the water-absorbing and swelling material are made of polymer materials, such as one or more of the following: polyester, polyethylene terephthalate (PET), polyetheretherketone (PEEK), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), ultra-high molecular weight polyethylene (UHMWPE), silicone, polyoxymethylene, polyphenylene sulfone, polysulfone, polyvinylidene fluoride, and polyamide. The substrate can be a polymer material such as PET, and the water-absorbing and swelling material can be a water-swellable material such as hydrogel or a porous foam material. In one embodiment, see [reference needed]. Figure 1f , Figure 1g , Figure 1h , Figure 1i , Figure 1j As shown, the water-absorbing and expanding material is in the form of a strip and is continuously distributed around the circumference of the support, or it is a plurality of blocks arranged at intervals; the annular part 120 has a grid structure, and the block-shaped water-absorbing and expanding material is respectively located in the hollow area of ​​the corresponding grid structure.

[0172] The water-absorbing and expanding material consists of multiple blocks arranged at intervals, with each block protruding radially outward relative to the support.

[0173] In one embodiment, see Figure 1j As shown, the anti-leakage part 160 includes an expandable material strip and a portion of an inner liner 141, with the expandable material strip 161 attached to the inner liner 141.

[0174] In one embodiment, the inner membrane 141 is made of an expandable material, and the expandable material strip 161 and the inner membrane 141 are an integral structure.

[0175] In one embodiment, see Figure 1j As shown, the expandable material strip 161 is connected to the inflow side of the inner membrane 141 and is a plurality of blocks arranged at intervals along the circumference of the support. The annular part has a grid structure, and the block-shaped water-absorbing and expanding material is respectively located in the hollow area of ​​the corresponding grid structure.

[0176] In one embodiment, see Figure 1f , Figure 1g , Figure 1h , Figure 1i As shown, the suture ring 150 has a threading mark 170, which is staggered from the connecting post 112 in the circumferential direction of the support. That is, the threading mark 170 is set in the middle of two adjacent connecting posts 112 in the circumferential direction of the support.

[0177] In one embodiment, see Figure 2h , Figure 2i As shown in the figure, the dashed line indicates the direction of blood flow. In the loaded state, the suture ring 150 has a wavy structure extending circumferentially along the stent.

[0178] The part located on the inflow side is the trough;

[0179] The part located on the outflow side is the crest.

[0180] The support has a wave structure in both the loaded and released states, the difference being the difference in the height difference between the crests and troughs.

[0181] In one embodiment, see Figure 2h , Figure 2i As shown, the suture ring 150 has a threading mark 170, which is located at the trough position when loaded.

[0182] This application also provides an implantable expandable artificial heart valve, which has an implanted state and an expanded state after implantation. The implanted artificial heart valve has a first size, and the expanded artificial heart valve after implantation has a second size, which is larger than the first size.

[0183] Artificial heart valves have opposing inflow and outflow sides. Artificial heart valves include a stent. See [link to stent description]. Figure 1a and 1e As shown, the support includes:

[0184] The support part 110 is surrounded by multiple U-shaped frames 111, with the opening of each U-shaped frame 111 facing the outflow side. The sides of two adjacent U-shaped frames 111 are adjacent to each other to form a connecting post 112, and the sides of two adjacent U-shaped frames 111 converge at the top of the connecting post 112.

[0185] The annular portion 120 is a radially deformable mesh structure and is located on the inflow side of the support portion 110. At least a portion of the annular portion 120 in the circumferential direction is an expandable area 122, which is aligned with the inflow side of the connecting column 112 in the axial direction of the support.

[0186] The artificial heart valve provided in this application can be used in valve-in-valve surgery, which refers to placing a new valve inside another failed implanted valve. In order to place a new valve inside a failed implanted valve, it is necessary to further dilate the failed implanted valve to a certain extent so as to place a new valve of the same size or the next smaller size as the failed valve, thereby increasing the effective opening area of ​​the valve after implantation.

[0187] In this invention, the annular portion of the stent is a deformable mesh structure with circumferential deformation capability. In addition, by providing an expandable region 122 in the annular portion, sufficient expansion can be performed during flap-in-flap surgery to meet the needs of flap-in-flap surgery.

[0188] The implantation state of the artificial heart valve refers to the normal working state of the artificial heart valve after it is implanted into the human body. The post-implantation dilation state of the artificial heart valve refers to the state after the valve is dilated when a valve-in-valve surgery is required.

[0189] The implanted artificial heart valve has a first size, and the expanded artificial valve after implantation has a second size, which is 1-4 mm larger than the first size. The artificial heart valve has an overall cylindrical structure, and both the first and second sizes are the diameters of the cylindrical structure. Because the artificial heart valve also has flexible structures such as a diaphragm, it is not easy to accurately measure the diameter of the cylindrical structure. Therefore, the first and second sizes can also be defined as the diameters of the artificial heart valve stent.

[0190] The second size is 1-4 mm larger than the first size, which can meet the needs of valve-in-valve implantation. The expandable area 122 is more likely to deform and expand outward under radial force compared to other parts of the annular portion 120. Since the valve is implanted surgically, there is a suture between the valve and the valve annulus. The annular portion 120 is easy to deform and will not have an adverse effect on the positioning. Moreover, it is easier to expand circumferentially when valve-in-valve implantation is required, which is conducive to the implantation of the new valve.

[0191] The expandable region 122 is located on the inflow side of the annular portion. The position of the expandable region 122 is aligned with the inflow side of the connecting column 112. When subjected to external force, the circumferentially expanding parts of the annular portion 120 and the support portion 110 are aligned with each other in the axial direction. The deformation of the annular portion 120 and the support portion 110 restrains each other less. That is, when the annular portion 120 expands circumferentially, it will not be restrained by the support portion 110, and vice versa.

[0192] When the annular portion 120 expands outward under radial force, it adapts to the external force through the expandable region 122, thereby reducing the impact on the support portion 110, that is, reducing the impact on the shape of the leaflet 130 connected to the support portion 110.

[0193] In one embodiment, see Figure 1e As shown, the expandable region 122 is a frame structure that can extend in the circumferential direction of the support, and the area enclosed by the frame structure is an open region.

[0194] The expandable region 122 adopts a circumferentially extendable frame structure. When subjected to radial external force, the frame structure extends, causing the expandable region 122 to deform. The setting of the open region allows for a larger deformation.

[0195] In one embodiment, see Figure 1e As shown, the frame structure is V-shaped or W-shaped.

[0196] The V-shaped frame structure does not require balloon dilation. Utilizing the radial support force of the V-shaped frame structure itself, it fits tightly with the patient's original aortic valve annulus, enhancing valve stability, reducing paravalvular leakage, and lowering the complexity of the surgical procedure.

[0197] In one embodiment, see Figure 1e As shown, the number and circumferential position of the expandable regions 122 correspond one-to-one with the connecting columns 112. The number of expandable regions 122 is the same as the number of connecting columns 112, and the expandable regions 122 and the connecting columns 112 are aligned axially with the support.

[0198] The expandable region 122 and the connecting column 112 are in one-to-one correspondence. When subjected to external force, the circumferentially expanding parts of the annular part 120 and the support part 110 are aligned with each other in the axial direction. The deformation of the annular part 120 and the support part 110 restrains each other less. That is, when the annular part 120 expands circumferentially, it will not be restrained by the support part 110, and vice versa.

[0199] This application also provides a method for processing an artificial valve, including:

[0200] S100. Connect each leaflet to the outflow edge of the radially inner membrane of the support to form the first preform.

[0201] S200, forming a second pre-product by covering the radially outer side of the support;

[0202] S300. The first preform and the second preform are respectively connected to the stent to form the artificial valve.

[0203] In one embodiment, S100, an anti-leakage part is formed by attaching an anti-leakage material to the radially inner side of the support film, or by forming an anti-leakage part by using the folds of the radially inner side of the support film.

[0204] In one embodiment, S200, the first portion of the radially outer membrane of the support is used to wrap the stitching material to form a second preform.

[0205] In one embodiment, S200, the second portion of the radially outer membrane of the support is used to wrap the anti-leakage material to form a second preform.

[0206] In one embodiment, S200, a second preform is formed by utilizing the folds of the radially outer membrane of the support to form a suture portion and / or a leak-proof portion.

[0207] In one embodiment, the method for processing an artificial valve includes step S300:

[0208] S310, The first pre-made part is sewn to the bracket, and a first non-sewn area is reserved at the top of the adjacent connecting post 112;

[0209] S320, The second pre-made product is sewn to the bracket, and a second non-sewn area is reserved at the top of the adjacent connecting post 112;

[0210] S330. Sew the first non-sutured area and the second non-sutured area together with the support to fix them to each other.

[0211] To deliver the artificial valve into the body, this application also provides a valve holder, see [link to relevant documentation]. Figure 2a , Figure 2b , Figure 2c , Figure 2fAs shown, the valve holder includes:

[0212] The control handle 210 has a distal end and a proximal end;

[0213] The valve clip 230 has an adaptation structure 231 on its outer periphery that corresponds to the artificial valve;

[0214] Sleeve 220 is movably positioned on the outer periphery of valve clip 230, and sleeve 220 can switch between two states: wrapping and exposing adapter structure 231;

[0215] Two transmission components 240 are nested together and their distal ends are respectively connected to valve buckle 230 and sleeve 220. The proximal ends of the two transmission components 240 are connected to control handle 210, and at least one of them is movablely engaged with control handle 210 to adapt to the state switching of sleeve 220.

[0216] The proximal end of the control handle 210 is the end closer to the operator, and the distal end is the end farther away from the operator.

[0217] The valve holder shrinks the artificial valve to a smaller size and delivers it to the target location. See [link / reference] Figure 2g , Figure 2h As shown, before the surgery, the artificial valve is connected to the valve clip 230 through the adapter structure 231. By operating the control handle 210, the sleeve 220 is switched from exposing the adapter structure 231 to wrapping the adapter structure 231. The artificial valve is compressed radially to reduce its size so as to fit the small incision position for insertion.

[0218] In the valve holder, only the sleeve 220 and the valve clip 230 are close to the artificial valve and have limited obstruction. The control handle 210 is far away from the artificial valve, so it is not easy to block the surgeon's view and it is convenient to observe the valve's condition during valve delivery.

[0219] The artificial valve compressed in the cannula is smaller in size, makes it easier to pass through the sinus duct junction, and does not affect the surgeon's field of vision during delivery.

[0220] The working process of the valve holder is described in [reference]. Figures 2g to 2m As shown, the details are as follows:

[0221] See Figure 2g As shown, the sleeve 220 exposes the adapter structure 231 of the valve clip 230, and the artificial valve is combined with the adapter structure 231 of the valve clip 230.

[0222] See Figure 2h As shown, the sleeve 220 is wrapped around the adapter structure 231 by operating the control handle 210, and the artificial valve is in a compressed state.

[0223] See Figure 2iAs shown, the position of the sleeve 220 is locked by controlling the handle 210;

[0224] See Figure 2j As shown, the surgeon passes the suture through the original valve annulus and through the suture ring 150 of the compressed artificial valve, and moves the compressed artificial valve along the suture to deliver it to the original valve annulus.

[0225] See Figure 2k As shown, by controlling the handle 210, the locking of the sleeve 220 position is released, and the sleeve 220 is operated to switch from the state of wrapping the adapter structure 231 to the state of exposing the adapter structure 231, the artificial valve is released, and gradually switches from the loading state to the release state.

[0226] See Figure 2l As shown, the artificial valve has completely detached from the valve clip 230 and returned to its original size;

[0227] See Figure 2m As shown, after the artificial valve is fully released, it is placed at the original valve annulus, and the original valve annulus is sutured to the artificial valve suture ring 150, and the valve holder is removed.

[0228] To avoid obstructing the surgeon's view, the 220 sleeve can be made of a transparent material.

[0229] The two transmission components can slide relative to each other in the axial direction to switch between two states: sleeve 220 enclosing and exposing the fitting structure 231. One transmission component is fixed relative to the control handle 210, while the other transmission component can move axially. The axially movable transmission component can be linked with sleeve 220 or with valve buckle 230.

[0230] In one embodiment, see Figure 2a , Figure 2b , Figure 2c As shown, the far end of the sleeve 220 is a flared structure, and the opening edge of the flared structure is provided with a plurality of clearance grooves 221 arranged at intervals along the circumference.

[0231] See Figure 2h As shown, when the artificial valve is compressed, the relief groove 221 can accommodate the folds of the suture ring 150, reducing the radial dimension of the artificial valve after compression.

[0232] In one embodiment, see Figure 2a , Figure 2f As shown, Figure 2f The sleeve 220 structure is omitted, and the internal valve buckle 230 structure is shown. The valve buckle 230 is columnar, and the adapter structure 231 is an anti-dislodgement groove and / or anti-dislodgement column set on the outer periphery of the valve buckle 230. The circumferential distribution position of the clearance groove 221 corresponds to the adapter structure 231.

[0233] In order to stably hold the artificial valve on the valve clip 230, the valve clip 230 and the adapter structure 231 of the artificial valve are complementary structures. For example, if the artificial valve is provided with an anti-dislodgement ear, then the valve clip 230 is provided with an anti-dislodgement groove corresponding to the shape of the anti-dislodgement ear; if the artificial valve is provided with an anti-dislodgement groove, then the valve clip 230 is provided with an anti-dislodgement post corresponding to the shape of the anti-dislodgement groove.

[0234] The circumferential distribution of the clearance groove 221 corresponds to the adapter structure 231, which is based on the state of the artificial valve after compression, so that the clearance groove 221 can better accommodate the folded parts of the artificial valve.

[0235] The control handle 210 includes:

[0236] Housing 211, the interior of housing 211 is a mounting chamber, one of the two transmission components is fixed to the mounting chamber;

[0237] The movable base 212 is slidably disposed in the mounting chamber, and the other of the two transmission components is fixed to the movable base 212;

[0238] A gear adjustment mechanism 213 is disposed between the movable seat 212 and the mounting chamber, restricting the movable seat 212 to at least two gears;

[0239] The control button 214 is connected to the movable base 212 and at least a portion extends to the outside of the housing 211.

[0240] In one embodiment, see Figure 2d , Figure 2e As shown, the control handle 210 includes:

[0241] Housing 211, housing 211 contains an installation chamber, and a transmission component is fixed to the installation chamber;

[0242] The movable base 212 is slidably disposed in the mounting chamber, and another transmission component is fixed to the movable base 212;

[0243] A gear adjustment mechanism 213 is disposed between the movable seat 212 and the mounting chamber, restricting the movable seat 212 to at least two gears;

[0244] The control button 214 is connected to the movable base 212 and at least a portion extends to the outside of the housing 211.

[0245] The control button 214 is connected to the movable seat 212. The movable seat 212 can be moved by turning the control button 214. The movable seat 212 will be restricted from moving when it reaches the gear position corresponding to the gear adjustment mechanism 213, unless external force is applied by the control button 214 to overcome this restriction.

[0246] The gear adjustment mechanism 213 has at least two gears, each corresponding to one of the following positions:

[0247] a) The position where the artificial valve is fully compressed;

[0248] b) The position where the artificial valve is fully deployed.

[0249] In addition, the settings can be configured to correspond to different states during the release of the artificial valve. For example, a corresponding setting can be set for the state where the suture ring of the artificial valve is fully open. When the suture ring of the artificial valve is kept in the fully open state, the suture ring and the original valve ring are sutured together with sutures. After suturing is completed, the artificial valve is fully released and the valve holder is withdrawn.

[0250] Complete compression of an artificial valve does not refer to the maximum possible compression of the artificial valve, but rather to the final compression state that the artificial valve needs to achieve within the valve holder.

[0251] By limiting the movement of the movable seat 212 through the gear adjustment mechanism 213, the surgeon can avoid valve dislodgement or displacement due to misoperation during the operation, thus ensuring the safety of the surgical procedure.

[0252] The gear adjustment mechanism includes:

[0253] Multiple slots 215 are arranged at intervals along the axial direction of the housing 211, and the multiple slots 215 are disposed on one of the movable base 212 and the inner wall of the housing 211.

[0254] The elastic latch 216 is disposed in the other of the movable seat 212 and the inner wall of the housing 211. The elastic latch 216 engages with the corresponding slot 215 when the movable seat 212 is in different positions.

[0255] The movable seat 212 is fixed in different positions by the cooperation of the elastic latch 216 and the slot 215. When the slot 215 is provided on the movable seat 212, the elastic latch 216 is provided on the inner wall of the housing 211, or when the slot 215 is provided on the inner wall of the housing 211, the slot 215 is provided on the inner wall of the housing 211.

[0256] The number of card slots is the same as the number of gear positions. Each gear position corresponds to the position of a moving base. The number of card slots can be set as needed.

[0257] In one embodiment, see Figure 2d , Figure 2e As shown, the gear adjustment structure includes:

[0258] Three slots 215 are arranged at intervals along the axial direction of the housing 211, and the three slots 215 are disposed on the inner wall of the housing 211;

[0259] The elastic latch 216 is disposed on the movable seat 212. The elastic latch 216 engages with the corresponding slot 215 when the movable seat 212 is in different positions.

[0260] In one embodiment, see Figure 2d , Figure 2e As shown, the movable seat 212 has two elastic strips 217 fixed side by side. One section of each elastic strip 217 protrudes outward from each other to form two elastic latches 216. The latches 215 are in two rows, each corresponding to one of the elastic latches 216. Figure 2e One of the slots 215 is partially blocked by the housing 211.

[0261] The positions of the two rows of slots 215 correspond one-to-one, and each pair of elastic latches 216 is inserted into the corresponding slot 215.

[0262] In one embodiment, see Figure 2d , Figure 2e As shown, the inner wall of the housing 211 is provided with a guide structure 218 for guiding the movable seat 212. The guide structure 218 is a sliding groove fixed to the inner wall of the housing 211. The housing 211 is also provided with a sliding groove for guiding the movement of the control button 214.

[0263] In one embodiment, see Figure 2d , Figure 2e As shown, both transmission components are tubular, namely an inner tube 241 connected to the valve buckle 230 and an outer tube 242 connected to the sleeve 220. The proximal end of the outer tube 242 is fixed to the movable seat 212, and the proximal end of the inner tube extends past the movable seat 212 and is fixed to the housing 211.

[0264] When operating the control handle 210, the inner tube 241 remains stationary relative to the control handle 210. By changing the position of the outer tube 242, the sleeve 220 can switch between two states: wrapping around and exposing the adapter structure 231 of the valve buckle 230.

[0265] In one embodiment, see Figure 2d , Figure 2e As shown, a locking element 219 is movably mounted on the housing 211, and the locking element 219 can switch between two states: interference and avoidance of the moving seat 212.

[0266] When the artificial valve is in a fully compressed state, the locking element 219 interferes with the movement of the moving seat 212, thus stably installing the artificial valve in the valve holder and preventing misoperation during movement. When it is necessary to release the artificial valve from the valve holder, the locking element 219 is switched to a state that avoids the movement of the moving seat 212.

[0267] In one embodiment, see Figure 2dAs shown, the far end of the movable seat 212 is provided with an L-shaped limiting groove 250. The limiting groove 250 includes a longitudinal section extending along the axial direction of the housing 211 and a transverse section that is perpendicularly connected to the longitudinal section, wherein the end of the longitudinal section is an open opening.

[0268] The locking element 219 is located in the transverse section and the longitudinal section in the two states of interference and avoidance of the moving seat 212, respectively.

[0269] During the transition of the artificial valve from an uncompressed state to a fully compressed state, the locking member 219 enters the longitudinal segment through the opening. When the artificial valve reaches a fully compressed state, the locking member 219 is located at the intersection of the longitudinal and transverse segments. Moving the locking member 219 along the transverse segment moves it away from the longitudinal segment. Because the locking member 219 and the transverse segment interfere with each other in the direction of movement of the moving seat 212, the movement of the moving seat 212 is restricted.

[0270] When it is necessary to release the artificial valve, the locking member 219 is moved along the transverse section so that the locking member 219 is located in the longitudinal section. The locking member 219 can move along the longitudinal section in the movement direction of the moving seat 212, thereby releasing the movement restriction on the moving seat 212.

[0271] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0272] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A stent for a prosthetic valve having opposite inflow and outflow sides, characterized by, The support part is surrounded by a plurality of U-shaped frames, the openings of the U-shaped frames face the outflow side, the side edges of adjacent two U-shaped frames are adjacent to each other to form a joint column, and the side edges of the adjacent two U-shaped frames meet at the top end of the joint column. The annular part is a mesh structure that is radially deformable, and is located on the inflow side of the support part as a whole, and is connected to the inflow side of the U-shaped frame. The mesh structure of the annular part is a unit cell arranged in the circumferential direction, the unit cell is only one circle in the axial direction, and at least one unit cell is a deformation release cell open to the inflow side of the annular part. The connection part between the annular part and the support part is at a plurality of positions and corresponds to the bottom of each U-shaped frame.

2. The stent of the prosthetic valve according to claim 1, characterized in that, The stent has opposite loading and release states, wherein:

3. The stent of the prosthetic valve according to claim 1, wherein, In the loading state, the outflow side of the support part is radially inwardly gathered, and the annular part is flared as a whole toward the inflow side. In the release state, the outflow side of the support part is radially outwardly expanded, and the stent is a straight cylinder structure as a whole. There are three U-shaped frames, the bottom on the inflow side of each U-shaped frame is a connection end, and the annular part is fixed to each connection end through the vertex of the corresponding position of the mesh structure.

4. The stent of the prosthetic valve according to claim 1, wherein, The frame strip strength of the U-shaped frame is greater than the frame strip strength of the annular part.

5. The stent of the prosthetic valve of claim 1, wherein, The top end of the joint column is widened in the circumferential direction of the stent to form a connection ear for adapting to the conveying system.

6. The stent of the prosthetic valve of claim 1, wherein, The top end of the joint column is widened to form a T-shaped structure in the circumferential direction of the stent, and the horizontal straight part of the T-shaped structure is the connection ear.

7. The stent of the prosthetic valve according to claim 6, wherein, One or more communication strips are arranged between the side edges of the adjacent two U-shaped frames, and the communication strip surrounds one or more hollow windows at the joint column position.

8. The stent of the prosthetic valve of claim 1, wherein, In the axial direction of the stent, the length of the annular part is L1, the length of the support part is L2, and L1 is less than L2.

9. The stent of a prosthetic valve according to claim 1, wherein, L1: L2 = 1: 1.5 ~ 1:

3.

10. The stent of the prosthetic valve according to claim 9, characterized in that, The number of all unit cells is 9-24, and is an integer multiple of the number of U-shaped frames.

11. The stent of the prosthetic valve of claim 1, wherein, Each U-shaped frame spans 3-6 unit cells in the circumferential direction of the stent.

12. The stent of the prosthetic valve of claim 1, wherein, In the flattened state, each unit cell has the same axial height.

13. The stent of a prosthetic valve according to claim 1, wherein, Except for the deformation release cell, the remaining unit cells are approximately rhombic or hexagonal.

14. The stent of the prosthetic valve of claim 1, wherein, The number of deformation release cells is the same as the number of joint columns, and the deformation release cell and the joint column are aligned in the axial direction of the stent.

15. The stent of the prosthetic valve of claim 1, wherein, The deformation release cell is a V-shaped frame strip, and the opening of the V shape faces the inflow side of the annular part.

16. The stent of the prosthetic valve of claim 1, wherein, The stent is integrally cut from a shape memory alloy.

17. The stent of a prosthetic valve according to any one of claims 1-16, wherein, ​

Images