Anti-reflux stent and prosthetic valve device for facilitating radial contraction

Abstract

The application discloses an anti-reflux stent and artificial valve device convenient for radial contraction and relates to the technical field of medical devices.The anti-reflux stent convenient for radial contraction comprises connecting pieces, positioning pieces, fastening pieces, clamping end and a reinforcing net, the connecting pieces are arranged at intervals in the circumferential direction at the distal end of the anti-reflux stent convenient for radial contraction; the positioning pieces and the fastening pieces are arranged between the adjacent connecting pieces, and the positioning pieces and the fastening pieces form a clamping space for clamping the native valve leaflet in the relaxed state; the clamping end is in the shape of a broken line and forms a plurality of clamping units in the shape of a V with the opening facing away from the distal end of the anti-reflux stent convenient for radial contraction, the clamping unit comprises a first clamping unit connected with the proximal end of the fastening piece and a second clamping unit located between the adjacent first clamping units; the reinforcing net is composed of two self-expanding arcs, the distal ends of the two self-expanding arcs are connected with the adjacent two fastening pieces one by one, and the proximal ends of the two self-expanding arcs are connected with the clamping end respectively.The anti-reflux stent convenient for radial contraction can automatically adapt to the reduction of the valve annulus.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an anti-reflux stent and artificial valve device that facilitates radial contraction. Background Technology

[0002] Due to its advantages such as minimal invasiveness and rapid recovery, transcatheter aortic valve replacement (TVR) is increasingly being used in surgeries. In surgeries where the native heart valve is replaced with an artificial valve due to disease, taking aortic valve replacement for aortic regurgitation as an example, early surgical methods required cutting the sternum to suture the artificial valve to the aortic annulus. Currently, this has gradually changed to TVR. An anti-regurgitation stent is an important device in TVR aortic valve replacement, often fabricated from nickel-titanium tubing. During the procedure, the anti-regurgitation stent, with the artificial valve leaflets sutured, is first gripped and then delivered via a delivery system. The stent is then released, causing it to expand and open the artificial valve leaflets while simultaneously fixing the native valve leaflets.

[0003] Traditional stents generally require sufficient radial support to ensure stable placement in the aortic sinus. However, patients with regurgitation caused by aortic dilation typically have high systolic blood pressure. Because regurgitation leads to insufficient blood pumping, the heart compensates by increasing its pumping capacity, resulting in elevated blood pressure and valve annulus dilation. However, after stent implantation, the regurgitation disappears, and the heart's blood supply returns to normal. The compensatory pumping action gradually ceases, and the valve annulus shrinks. At this point, the aortic wall compresses the stent. Current stents, due to their relatively strong radial support, cannot automatically adapt to changes in the valve annulus.

[0004] Therefore, it is necessary to propose a relatively flexible regurgitation stent that will also undergo a certain degree of radial shrinkage during the process of annular shrinkage. Summary of the Invention

[0005] The purpose of this application is to provide an anti-regurgitation stent and artificial valve device that facilitates radial contraction, thereby solving the problem that the anti-regurgitation stent, due to its relatively strong radial support force, cannot automatically adapt to changes in the valve annulus.

[0006] To achieve the above objectives, the present invention provides the following technical solution.

[0007] An anti-backflow stent that facilitates radial contraction includes:

[0008] Connectors, each of which is circumferentially spaced at the distal end of the anti-backflow support that facilitates radial contraction;

[0009] The positioning element and the fastener are provided between adjacent connecting elements. The positioning element and the fastener are respectively bent toward the proximal end of the anti-backflow stent that facilitates radial contraction. In the extended state, in the radial direction of the anti-backflow stent that facilitates radial contraction, the proximal end of the positioning element is located outside its corresponding fastener. A clamping space for clamping the original leaflet is formed between the positioning element and the fastener.

[0010] The locking end is zigzag-shaped and forms several V-shaped locking units with openings facing away from the distal end of the anti-backflow bracket that facilitates radial contraction. The locking unit includes a first locking unit connected to the proximal end of the fastener and a second locking unit located between adjacent first locking units.

[0011] A reinforcing mesh is provided between adjacent fasteners. The reinforcing mesh is composed of two self-expanding arcs. The distal ends of the two self-expanding arcs are connected to the two adjacent fasteners in a one-to-one correspondence, and the proximal ends of the two self-expanding arcs are respectively connected to the locking end.

[0012] Optionally, the proximal ends of each of the positioning units are sequentially connected to form a hollow structure; the distal end of the first positioning unit is connected to the fastener.

[0013] Optionally, four second card slot units are provided between adjacent first card slot units.

[0014] Optionally, the proximal ends of the two self-expanding arcs are connected one-to-one with the distal ends of the two adjacent second positioning units.

[0015] Optionally, the two self-expanding arcs are defined as a first self-expanding arc and a second self-expanding arc, with the middle part of the first expansion arc and the middle part of the second self-expanding arc connected.

[0016] The first self-expanding arc includes a first rod and a second rod connected in sequence, and the second self-expanding arc includes a third rod and a fourth rod. The first rod, the second rod, the third rod, and the fourth rod are connected to each other, wherein, in the extended state:

[0017] The distal ends of the first rod and the fourth rod bend away from each other, while the proximal ends of the first rod and the fourth rod bend closer to each other; the degree of bending of the first rod and the fourth rod is greater than that of the second rod and the third rod.

[0018] Optionally, in the contracted state, both the first and second self-expanding arcs are straight lines, the first and second rods are of equal length, and the third and fourth rods are of equal length.

[0019] Optionally, in the axial direction of the anti-backflow bracket that facilitates radial contraction, the fastener is divided into an upper half and a lower half. The upper half is used to connect the connector, and the proximal end of the fastener is formed on the lower half. The distal ends of the first self-expanding arc and the second self-expanding arc are connected to the upper half of the fastener.

[0020] Optionally, the positioning element includes a first positioning arm, a second positioning arm, and a proximal end of the positioning element, wherein the first positioning arm and the second positioning arm are connected through the proximal end of the positioning element.

[0021] Optionally, the fastener includes a first fastening arm, a second fastening arm, and a fastener proximal end connecting the first fastening arm and the second fastening arm, wherein the first fastening arm and the second fastening arm are respectively connected to two adjacent connectors;

[0022] The connector includes a positioning member connecting part, a fastener connecting part, and a sewing part. The sewing part is provided with a sewing through hole and is located between the positioning member connecting part and the fastener connecting part.

[0023] The connector further includes a connecting block and a web plate, wherein the connecting block is connected to the positioning member connecting part through the web plate;

[0024] The width of the web is smaller than the width of the connecting block.

[0025] Optionally, the anti-backflow bracket that facilitates radial contraction further includes a support member disposed between adjacent connectors, with both ends of the support member corresponding to the two connectors, the support member bending away from the connectors, and the proximal end of the support member being closer to the connectors than the proximal end of the positioning member.

[0026] Optionally, the anti-backflow support that facilitates radial contraction further includes a marker and a fixing member, wherein the proximal end of the fixing member is connected to the positioning member, and the marker is mounted on the fixing member.

[0027] Optionally, the fixing member includes a fixing part and a limiting part, with the two ends of the fixing part respectively connected to the limiting part and the proximal end of the positioning member; the marking member is a C-shaped structure that wraps around the fixing part, and the limiting part is used to prevent the marking member from detaching from the fixing part.

[0028] Optionally, the fastener is provided with a fixing hole, and the marking element is embedded in the fixing hole.

[0029] Optionally, the distal end of the fixing part includes a wire through hole for the wire to pass through, so as to control the degree of relaxation of the positioning member.

[0030] An artificial valve device, comprising:

[0031] The anti-backflow bracket, which facilitates radial contraction as described in any of the preceding claims, forms an installation channel;

[0032] The film is applied and fixed to the fastener;

[0033] An artificial leaflet is fixed to the membrane and the connector and sewn to the connector. The artificial leaflet is used to control the opening and closing of the installation channel.

[0034] A leak-proof skirt is provided at the locking end to prevent leakage from the side of the anti-backflow bracket that facilitates radial contraction.

[0035] Compared with the prior art, the beneficial effects of this application are as follows:

[0036] (1) By using a reinforcing mesh to connect adjacent fasteners and the locking end between the two fasteners, the two self-expanding arcs of the reinforcing mesh are set to a structure in which the proximal end connects to the locking end and the distal end connects to the fastener. On the one hand, this improves the radial and circumferential support of the anti-reflux stent that is easy to contract radially, and reduces the degree of deformation caused by external forces on the anti-reflux stent that is easy to contract radially. At the same time, since the self-expanding arc is not a structure that extends in the circumferential direction, but a structure that extends in the axial direction, the elastic force generated by the two self-expanding arcs in the extended state is more reflected in the axial direction, and the elastic force given to the anti-reflux stent that is easy to contract radially is relatively small. Therefore, the radial support provided by the reinforcing mesh is not particularly strong. After the anti-reflux stent that is easy to contract radially is implanted, the reflux disappears, and after the heart's blood supply function returns to normal, the heart's compensatory pumping gradually disappears. During the process of valve annulus shrinkage, the two self-expanding arcs lengthen, and the anti-reflux stent that is easy to contract radially is relatively compressed and contracts to adapt to the size of the valve annulus, thereby reducing the harm to the human body.

[0037] (2) The reinforced net 8 also effectively prevents the original leaflets from intruding into the installation channel formed by the reflux support and interfering with the work of the artificial leaflets.

[0038] (3) In the prior art, the locking end is formed by several rhomboid meshes, that is, the locking unit is a rhomboid structure. In this embodiment, the locking end 5 composed of rhomboid meshes is designed as a broken line structure composed of multiple connecting rods. The two adjacent connecting rods form a V-shaped structure instead of rhomboid meshes. When the height of the locking end 5 remains unchanged, the length of the broken line structure connecting rod is longer than the length of the rhomboid mesh connecting rod. Therefore, when the number of V-shaped structures is equal to the number of rhomboid meshes and the opening diameter of the bracket is the same, the opening angle α of the adjacent rhomboid mesh connecting rod is greater than the opening angle β of the adjacent broken line structure connecting rod. Although nickel-titanium metal has superelasticity, the deformation is also limited. Excessive deformation will still affect the performance of nickel-titanium alloy. The adjacent connecting rods of the locking end need to expand from compression to near 0° to α, while the adjacent connecting rods of the locking end of the polygonal structure expand from compression to near 0° to β. Obviously, the deformation at the connection of the adjacent connecting rods of the locking end composed of the rhombus grid is greater than that of the connection of the adjacent connecting rods of the locking end composed of the polygonal structure. Therefore, the elasticity of the locking end composed of the rhombus structure after opening is not as good as that of the locking end composed of the connecting rod structure. Thus, the locking end composed of the connecting rod structure can more flexibly adapt to the shrinkage of the valve ring. Moreover, the deformation at the connection of the connecting rod of the locking end composed of the connecting rod structure is smaller than that at the connection of the connecting rod of the locking end composed of the rhombus grid structure. Therefore, it has less impact on the fatigue strength of the locking end and / or is less likely to cause deformation and fracture of the locking end connecting rod during compression and expansion. Attached Figure Description

[0039] The technical features and advantages of the present invention will be more fully understood by taking into account the accompanying drawings and the following detailed description.

[0040] Figure 1 This is a schematic diagram of the structure of the anti-backflow stent in the extended state, which facilitates radial contraction, according to Embodiment 1 of the present invention.

[0041] Figure 2 This is an unfolded view of the anti-backflow support for easy radial contraction according to Embodiment 1 of the present invention in the contracted state, in which the markings are hidden;

[0042] Figure 3 The diagrams show a structural comparison of the locking end in Embodiment 1 of the present invention, used to illustrate the working principle of the locking end in Embodiment 1 by comparing it with the prior art. (a) shows a partial structure of the existing locking end, and (b) shows a partial structure of the locking end in Embodiment 1. Figure 1 Enlarged view of part A;

[0043] Figure 4 for Figure 2 Enlarged view of part B;

[0044] Figure 5 This is a partial structural diagram of the anti-backflow support that facilitates radial contraction in Embodiment 1 of the present invention after it has been deployed in the contracted state;

[0045] Figure 6 This is a schematic diagram of the structure of the marker in Embodiment 1 of the present invention;

[0046] Figure 7 This is a front view of the radially contractible anti-backflow stent of Embodiment 2 of the present invention in its extended state, where the locking end is not shown.

[0047] Figure label:

[0048] Connector 1

[0049] Positioning component connecting part 11

[0050] Fastener connection part 12

[0051] Suture 13

[0052] Suture through hole 131

[0053] Connector block 14

[0054] Web 15

[0055] Positioning component 2

[0056] First positioning arm 21

[0057] Second positioning arm 22

[0058] Positioning component proximal end 23

[0059] Support component 33

[0060] Fastener 4

[0061] First fastening arm 41

[0062] Second fastening arm 42

[0063] Fastener proximal end 43

[0064] Card position 5

[0065] First card slot unit 51

[0066] Second card slot unit 52

[0067] Marker 6

[0068] Central Marking Section 61

[0069] Fastener 7

[0070] Limiting part 71

[0071] Fixing part 72

[0072] Pull the wire through hole 73

[0073] Fixing hole 74

[0074] Strengthen Network 8

[0075] First self-expanding arc 81

[0076] First shot 811

[0077] Second shot 812

[0078] Second self-expansion arc 82

[0079] Third shot 821

[0080] Fourth shot 822 Detailed Implementation

[0081] Unless otherwise defined, the technical or scientific terms used in this specification and claims shall have the ordinary meaning as understood by one of ordinary skill in the art to which this invention pertains.

[0082] In the description of this invention, it should be understood that the terms "center", "longitudinal", "lateral", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0083] Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0084] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art will understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0085] In any of the following embodiments, the radially contractible anti-backflow stent has one end close to the apex of the heart and the other end far from the apex in the use state. During the description, the "proximal end" of a component refers to the end of the component close to the apex in the use state, and correspondingly, the "distal end" of a component refers to the end of the component far from the apex in the use state. The radially contractible anti-backflow stent in any of the following embodiments can be extended and compressed. In the use state, it is in an extended state, defined as the "stretched state"; in the non-use state, for ease of storage and protection, it is artificially compressed radially to a certain state, defined as the "contracted state". In the following description of the radially contractible anti-backflow stent, the terms "circumferential," "axial," "radial," and "axis" are all relative to the radially contractible anti-backflow stent. It should be noted that "axial" here refers generally to the direction of the "axis," without any positional limitation. For example, when the "axis" extends vertically, "axial" is understood as the "vertical direction," not just the location of the "axis." When the outer surface of a component is mentioned in the following description, it refers to the side of the component that is away from the axis of the radially contractile anti-reflux stent, i.e., the side opposite to the inner wall of the blood vessel. The following description of the radially contractile anti-reflux stent involves the native leaflets. The side of the native leaflets that is in contact with each other when they are functioning normally is defined as the closed side, and the side of the native leaflets opposite to the closed side is defined as the non-closed side.

[0086] Please see Figures 1 to 6 Understanding this embodiment. This embodiment provides a radially contractile anti-reflux stent for use in heart valve replacement surgery. The radially contractile anti-reflux stent, in its contracted state, is transported to the appropriate position via a delivery device and then released, ultimately functioning in its extended state. The radially contractile anti-reflux stent has a hollow structure with open edges; the hollow portion is used to house artificial leaflets to achieve the function of the original leaflets.

[0087] The anti-backflow support for easy radial contraction includes a support body with a hollow structure and openwork around its perimeter. The support body includes a connector 1, a positioning component 2, a fastener 4, a locking end 5, and a reinforcing mesh 8.

[0088] Connector 1 is located at the distal end of the anti-backflow support that facilitates radial contraction, and is spaced circumferentially along the anti-backflow support that facilitates radial contraction. Adjacent connectors 1 are connected by positioning elements 2, that is, a positioning element 2 is provided between any group of adjacent connectors 1.

[0089] The two ends of the positioning member 2 are connected to the two adjacent connecting members 1 in a one-to-one correspondence. The part between the two ends of the positioning member 2 is bent toward the proximal end of the anti-backflow support that facilitates radial contraction, that is, the positioning member 2 is bent toward the direction away from the connecting member 1, so that the positioning member 2 forms a shape with the opening facing the distal end of the anti-backflow support that facilitates radial contraction.

[0090] Fasteners 4 and positioning elements 2 are configured in a one-to-one correspondence, that is, there is one fastener 4 between each group of adjacent connecting elements 1; wherein, in the axial direction of the anti-reflux stent that facilitates radial contraction, the fastener 4 is closer to the proximal end of the anti-reflux stent that facilitates radial contraction than its corresponding positioning element 2. When the anti-reflux stent that facilitates radial contraction is in the extended state, in the radial direction of the anti-reflux stent that facilitates radial contraction, the proximal end of the positioning element 2 is located outside the fastener 4, thereby forming a clamping space between the positioning element 2 and its corresponding fastener 4 for clamping the native leaflet, so that the positioning element 2 can be inserted between the native leaflet and the inner wall of the blood vessel, and the native leaflet is located in the clamping space.

[0091] The locking end 5 is located at the proximal end of the fastener 4, serving as an anchor to prevent the anti-backflow stent, which facilitates radial contraction, from moving away from the apex. The locking end 5 is zigzag-shaped and forms several V-shaped locking units with openings opposite to the distal end of the anti-backflow stent, which facilitates radial contraction. That is, the locking end 5 is bent multiple times, or it can be understood that the locking end 5 is formed by multiple connecting rods connected in sequence to form a bent shape, thereby forming several locking units. V-shaped structures are also formed between adjacent locking units, and the openings of these V-shaped structures are opposite to the openings of the locking units.

[0092] The locking unit includes a first locking unit 51 connected to the proximal end of the fastener 4 and a second locking unit 52 located between adjacent first locking units 51. That is, a part of the locking unit is connected to the fastener and is defined as the first locking unit 51, and a part of the locking unit is not connected to the fastener and is defined as the second locking unit 52.

[0093] The reinforcing mesh is placed between adjacent fasteners 4, and the proximal end of the reinforcing mesh 8 is connected to the distal end of the locking end 5. The reinforcing mesh is composed of two self-expanding arcs, and the distal ends of the two self-expanding arcs are connected to the two adjacent fasteners 4 in a one-to-one correspondence. The proximal ends of the two self-expanding arcs are respectively connected to the locking end 5.

[0094] In operation, the positioning element 2 is positioned between the non-closing surface of the original leaflet and the inner wall of the blood vessel. The outer surface of the positioning element 2 contacts the inner wall of the blood vessel, and the inner surface contacts the non-closing surface of the original leaflet. The proximal end of the positioning element 2 contacts the sinus floor. A channel is formed between the closing surfaces of each original leaflet, and the fastener 4 is located inside this channel, i.e., the fastener 4 is located on one side of the closing surface of the original leaflet. This channel provides space for the artificial leaflet, which can be directly or indirectly installed on the fastener 4 to replace the original leaflet and realize its function.

[0095] As can be seen from the above description, the embodiments of the present invention have at least the following advantages:

[0096] (1) In this embodiment, the reinforcing mesh 8 is used to connect the adjacent fasteners 4 and the locking end 5 between the two fasteners 4. The two self-expanding arcs of the reinforcing mesh 8 are set to connect the locking end 5 at the proximal end and the fastener 4 at the distal end. On the one hand, this improves the radial and circumferential support of the anti-reflux stent that is easy to contract radially, and reduces the degree of deformation caused by external force on the anti-reflux stent that is easy to contract radially. At the same time, since the self-expanding arc is not a structure that extends in the circumferential direction, but a structure that extends in the axial direction, the elastic force generated by the two self-expanding arcs in the stretched state is more reflected in the axial direction, and the elastic force given to the anti-reflux stent that is easy to contract radially is relatively small. Therefore, the radial support provided by the reinforcing mesh 8 is not particularly strong. After the anti-reflux stent that is easy to contract radially is implanted, the reflux disappears. After the heart blood supply function is normal, the heart's compensatory pumping gradually disappears. During the process of valve annulus shrinkage, the two self-expanding arcs lengthen, and the anti-reflux stent that is easy to contract radially is relatively compressed and contracts to adapt to the size of the valve annulus, thereby reducing the harm to the human body.

[0097] (2) The reinforced net 8 also effectively prevents the original leaflets from intruding into the installation channel formed by the reflux support and interfering with the work of the artificial leaflets.

[0098] (3) Figure 3 As shown in (a), in the prior art, the positioning end is formed by enclosing several rhomboid meshes, that is, the positioning unit is a rhomboid structure, such as Figure 3 As shown in (b), in this embodiment, the locking end 5 composed of rhomboid mesh is designed as a broken line structure composed of multiple connecting rods. Adjacent connecting rods form a V-shaped structure instead of the rhomboid mesh. With the height H of the locking end 5 remaining constant, the length L2 of the broken line structure connecting rod is longer than the length L1 of the rhomboid mesh connecting rod. Therefore, when the number of V-shaped structures equals the number of rhomboid meshes, and the bracket opening diameter is the same, the opening angle α of adjacent rhomboid mesh connecting rods is greater than the opening angle β of adjacent broken line structure connecting rods. Although nickel-titanium metal has superelasticity, its deformation is limited. Excessive deformation will still affect the performance of the nickel-titanium alloy. The adjacent connecting rods of the locking end composed of rhomboid mesh need to be compressed... The expansion is near 0° to α, while the adjacent connecting rod of the zigzag structure locking end 5 is compressed and expands to β. Obviously, the deformation of the adjacent connecting rod connection of the locking end composed of rhomboid mesh is greater than that of the adjacent connecting rod connection of the zigzag structure locking end 5. Therefore, the elasticity of the locking end after opening is not as good as that of the locking end 5 composed of link structure. Thus, the locking end 5 composed of link structure can more flexibly adapt to the shrinkage of the valve ring. Moreover, the deformation of the connecting rod connection of the locking end 5 of link structure is smaller than that of the connecting rod connection of rhomboid mesh structure locking end. Therefore, its influence on the fatigue strength of the locking end 5 is also smaller, and / or it is not easy for the connecting rod of the locking end 5 to deform and break during the compression and expansion deformation process.

[0099] In this embodiment, the main body of the bracket is integrally formed. In other words, the connector 1, the positioning component 2, the fastener 4, the reinforcing mesh 8, and the locking end 5 are integrally formed. During processing, they can be cut out from the nickel-titanium alloy tube. After the main body of the bracket is cut out, it is equivalent to a contracted state. Further processing can obtain an extended state.

[0100] In this embodiment, there are three connectors 1, and correspondingly, there are three positioning members 2 and three fasteners 4, which better accommodates the three native valve structures of the aorta. In some other embodiments, as an alternative, the number of connectors 1 can be set to other integers, such as 2, 4, 5, etc.

[0101] In this embodiment, the connectors 1 are evenly distributed circumferentially along the anti-reflux stent, which facilitates radial contraction. The force between each connector 1 and the inner wall of the blood vessel is relatively uniform, reducing the risk of damage caused by uneven distribution of connectors 1 leading to localized stress concentration on the inner wall of the blood vessel. Admittedly, in some other embodiments, the different spacing between adjacent connectors 1 is also within the scope of protection of this invention.

[0102] In this embodiment, all positioning elements 2 and all fasteners 4 adopt the same structure, further improving the uniformity of the force between the anti-reflux stent, which facilitates radial contraction, and the vascular inner wall. Admittedly, in other embodiments, different structures may be used for the positioning elements 2 and / or different structures for the fasteners 4, which are also within the scope of protection of this invention.

[0103] In this embodiment, a reinforcing mesh 8 is provided between any two adjacent fasteners 4, so that the radially shrinking anti-backflow bracket has three reinforcing meshes 8.

[0104] In this embodiment, the proximal ends of each positioning unit are sequentially connected to form a hollow structure; the distal end of the first positioning unit 51 is connected to the fastener 4, thereby facilitating a more uniform and stable positioning effect of the proximal end of the radially contracting anti-backflow bracket throughout the entire circumference.

[0105] In this embodiment, four second locking units 52 are provided between adjacent first locking units 51. This ensures that during the switching between the extended and contracted states, the deformation of the first locking unit 51 and the second locking unit 52 is small, and the radial and circumferential support force of the entire locking end 5 is within a good range.

[0106] In this embodiment, the proximal ends of the two self-expanding arcs are connected one-to-one with the distal ends of the two adjacent second positioning units 52 between the two first positioning units 51. In other words, the span between the proximal ends formed by the two self-expanding arcs is equal to the span between the two adjacent second positioning units 52. On the one hand, this is beneficial for the radial contraction of the anti-backflow bracket, which is easy to contract radially. On the other hand, the self-expanding arcs in the contracted state will not interfere with the fasteners 4.

[0107] The two self-expanding arcs are defined as the first self-expanding arc 81 and the second self-expanding arc 82. In this embodiment, the middle part of the first self-expanding arc and the middle part of the second self-expanding arc 82 are connected. In other embodiments, the first self-expanding arc 81 and the second self-expanding arc 82 are independent of each other and are not directly connected, which is also within the protection scope of this invention.

[0108] In this embodiment, the first self-expanding arc 81 includes a first rod 811 and a second rod 812 connected in sequence, and the second self-expanding arc 82 includes a third rod 821 and a fourth rod 822. The first rod 811, the second rod 812, the third rod 821, and the fourth rod 822 are connected. In the extended state: the distal ends of the first rod 811 and the fourth rod 822 bend in directions away from each other, thus better absorbing force when switching between the extended and contracted states; the proximal ends of the first rod 811 and the fourth rod 822 bend in directions closer to each other, thus... The angle between the proximal ends of the first rod 811 and the second rod 812 is relatively small, making it less prone to breakage when switching between the extended and contracted states. The bending degree of the first rod 811 and the fourth rod 822 is greater than that of the second rod 812 and the third rod 821. During the shrinkage of the valve annulus, the elastic force provided by the first rod 811 and the fourth rod 822 is relatively large, while the elastic force provided by the second rod 812 and the third rod 821 is relatively small. This ensures that the elastic force provided by the entire reinforcing mesh is moderate, achieving both radial support and flexible adaptation to the size of the valve annulus.

[0109] In this embodiment, in the contracted state, the first self-expanding arc 81 and the second self-expanding arc 82 are both straight lines to facilitate processing. The first rod 811 and the second rod 812 are of equal length, and the third rod 821 and the fourth rod 822 are of equal length.

[0110] In this embodiment, along the axial direction of the anti-backflow bracket that facilitates radial contraction, the fastener 4 is divided into an upper half and a lower half of equal length. The upper half is used to connect to the connector 1, and the two distal ends of the lower half are connected to the upper half. The proximal end of the lower half corresponds to the proximal end of the fastener 4. Figure 2 The diagram uses dashed lines for simplification. The portion of fastener 4 above the dashed line is the upper half, and the portion below the dashed line is the lower half. The distal ends of the first self-expanding arc 81 and the second self-expanding arc 82 connect to the upper half of fastener 4. Thus, within the area formed by adjacent fasteners 4 and locking end 5, the reinforcing mesh can more effectively prevent the original leaflet from intruding into the installation channel formed by the regurgitation stent and interfering with the operation of the artificial leaflet.

[0111] In this embodiment, the positioning element 2 includes a first positioning arm 21, a second positioning arm 22, and a proximal end 23. The proximal ends of the first positioning arm 21 and the second positioning arm 22 are connected by the proximal end 23, forming a V-shaped or U-shaped structure. In this embodiment, the first positioning arm 21 and the second positioning arm 22 are symmetrically arranged, and the proximal end 23 is located in the middle of the positioning arm. Figure 2 As shown, when the anti-reflux stent in its contracted state, which facilitates radial contraction, is cut along the axial direction and unfolded, the first positioning arm 21 and the second positioning arm 22 are straight, and the proximal end 23 of the positioning element is arc-shaped. The arc-shaped proximal end 23 of the positioning element increases the contact area with the sinus floor, reduces the contact stress with the sinus floor, and lowers the risk of damaging the sinus floor and the risk of valve annulus rupture.

[0112] In this embodiment, when the anti-reflux stent, which facilitates radial contraction, is in its extended state: the positioning member 2 gradually extends from its distal end to its proximal end in a direction away from the axis of the anti-reflux stent that facilitates radial contraction. This can also be understood as the positioning member 2 being axially inclined relative to the anti-reflux stent that facilitates radial contraction, so that the distal end of the positioning member 2 abuts against the non-closed surface of the original leaflet. In this embodiment, the opening angle of the positioning member 2 relative to the axis is between 2° and 14°, which can improve the fixation effect of the original leaflet without pressing the original leaflet into the installation channel and affecting the operation of the artificial leaflet.

[0113] In this embodiment, in the extended state of the anti-backflow stent that facilitates radial contraction, the distance from the proximal end of the positioning member 2 to the proximal end of the locking end 5 along the axial direction is any value between 4mm and 8mm. This reduces the risk of the locking end 5 contacting the His bundle. This embodiment uses 6mm, while other embodiments may use 4mm or 8mm.

[0114] In this embodiment, the fastener 4 includes a first fastening arm 41, a second fastening arm 42, and a proximal end 43 connecting the first fastening arm 41 and the second fastening arm 42. The distal end of the first fastening arm 41 and the distal end of the second fastening arm 42 are respectively connected to two adjacent connectors 1. Figure 2 As shown, when the anti-backflow support in the contracted state is cut along the axial direction and unfolded, the first fastening arm 41 and the second fastening arm 42 are straight, and the proximal end 43 of the fastener is arc-shaped; when the anti-backflow support in the extended state is in the radially contracted state, the first fastening arm 41 and the second fastening arm 42 are curved.

[0115] In this embodiment, the connector 1 includes a positioning connector 11, a fastener connector 12, and a suture part 13. The suture part 13 is provided with a suture through hole 131 for suturing the distal end of the artificial valve. In this embodiment, the suture through hole 131 is an elongated hole, which improves the convenience of suturing. The suture part 13 is located between the positioning connector 11 and the fastener connector 12.

[0116] In this embodiment, the connector 1 further includes a connecting block 14 and a web 15. The connecting block 14 is connected to the positioning connector 11 via the web 15. The width of the web 15 is smaller than the width of the connecting block 14. During the delivery of an anti-reflux stent that facilitates radial contraction via catheter, the connecting block 14 is connected to the delivery device. In use, the connecting block 14 is attached to the inner wall of the blood vessel.

[0117] In this embodiment, the anti-reflux stent, which facilitates radial contraction, also includes a support member 3 disposed between adjacent connectors 1. The two ends of the support member 3 are connected to the two connectors 1 in a one-to-one correspondence. The portion between the two ends of the support member 3 is bent away from the connectors 1, and the proximal end of the support member 3 is closer to the connector 1 than the proximal end of the positioning member 2; that is, the proximal end of the support member 3 is located between the proximal ends of the connectors 1 and the positioning member 2. The support member 3 enhances the fixation of the native leaflet, thereby improving the stability of the artificial leaflet.

[0118] In this embodiment, the anti-reflux stent that facilitates radial contraction also includes a marker 6 and a fixation member 7 located at the proximal end of the positioning member 2. The proximal end of the fixation member 7 is connected to the positioning member 2. The marker 6 is made of radiopaque metal and is detachably installed on the fixation member 7. During the operation, the position of the marker 6 is observed through imaging to determine whether the proximal end of the positioning member 2 has reached the sinus floor.

[0119] In this embodiment, the fixing member 7 gradually approaches the axis of the anti-backflow support that facilitates radial contraction from its proximal end to its distal end. It can also be understood that the fixing member 7 is inclined relative to the axis, so that the distal end of the fixing member 7 can abut against the non-closed surface of the original leaflet.

[0120] In this embodiment, the fixing member 7 includes a limiting part 71 to prevent the marker 6 from detaching from the distal end of the fixing member 7. The fixing member 7 also includes a fixing part 72 on which the marker 6 is mounted. One end of the fixing part 72 is connected to the positioning member 2, and the other end is connected to the limiting part 71. At least a portion of the limiting part 71 protrudes relative to the surface of the fixing part 72 to limit the marker 6. In practical applications, the length of the fixing part 72 can be set to be greater than the length of the marker 6, allowing the marker 6 to move axially along the fixing part 72, thus providing slack for the installation of the marker 6 and facilitating quick installation onto the positioning member 2. Alternatively, the distal end of the marker 6 can abut against the limiting part 71, and the proximal end of the marker 6 can abut against the proximal end of the fixing member 7 or against the positioning member 2, thereby constraining the degree of freedom of the marker 6 in axial displacement and eliminating the risk of damage to the vascular wall and original valve leaflets caused by the axial movement of the marker 6.

[0121] In this embodiment, the limiting part 71 is a plate with a circular outline. In other embodiments, as an alternative, the limiting part 71 may be a protruding structure located on the fixing part 72, or a baffle partially embedded in the fixing part 72.

[0122] The distal end of the fixation element 7 has a suture hole 73 for the suture to pass through, controlling the opening angle of the positioning element 2 relative to the axis of the radially contractible anti-reflux stent. During application, the suture is used to control the opening angle of the positioning element 2, depending on the specific intraoperative environment, to facilitate capture of the original leaflet. Simultaneously, the expansion of the positioning element 2 can be flexibly controlled according to the specific installation environment, allowing the surgeon to control the positioning element 2 to open relative to the outside as needed. Then, the delivery device is used to control the radially contractible anti-reflux stent to retract a certain distance along the blood vessel, allowing for repeated fine-tuning of the radially contractible anti-reflux stent without damaging human tissue. By providing the suture hole 73 on the fixation element 7, the functions of the installation marker 6 and the control of the opening angle of the positioning element 2 are combined, improving the compactness of the radially contractible anti-reflux stent.

[0123] In this embodiment, each positioning element 2 is provided with a fixing element 7 at its proximal end, and each fixing element 7 is provided with a wire through hole 73, which is located on the limiting part 71. By controlling the synchronous opening and closing of each positioning element 2 with a wire, the opening angle of each positioning element 2 can be made the same. The positioning element 2 can quickly capture the original leaflet, thereby rapidly implanting the anti-reflux stent that facilitates radial contraction into the human body. At the same time, when facing irregularities and / or when the original leaflet is deformed due to lesions, making it difficult to insert the positioning element 2 between the non-closed surface of the original leaflet and the inner wall of the blood vessel, the opening angle of the positioning element 2 can be individually controlled by the wire to capture the corresponding original leaflet, thereby improving the accuracy and efficiency of intraoperative positioning of the anti-reflux stent that facilitates radial contraction.

[0124] The marker 6 can be a bendable plate. During installation, the central marker 61 of the bendable plate is aligned with the fixing part 72 of the fixing part 7. Then, the two sides of the bendable plate are bent twice consecutively against the fixing part 72. The thickness of the central marker 61 can be set to be less than the thickness of other parts of the bendable plate, effectively reducing the impact of the marker 6 on the flatness of the outer side of the positioning part 2 and reducing the impact of the unevenness of the proximal end of the positioning part 2 on the inner wall of the blood vessel. Figure 6 As shown, in this embodiment, the marker 6 is C-shaped, and the marker 6 is arranged through the marker from its proximal end to its distal end.

[0125] Example 2

[0126] This embodiment provides an anti-backflow bracket that facilitates radial shrinkage. The difference from Embodiment 1 lies in the structure of the fastener 7 and the marker 6, as well as the connection relationship between them.

[0127] like Figure 7 As shown, in this embodiment, the fixing member 7 and the marking member 6 are interlocked. The fixing member is provided with a fixing hole 74, and the marking member 6 is interlocked in the fixing hole 74. The outer contour of the marking member 6 is adapted to the size of the fixing hole 74 so as to facilitate the interlocking of the marking member 6 into the fixing member 7. The distal end of the fixing member 7 is also provided with a pull wire through hole 73, and the function of the pull wire through hole 73 is the same as in embodiment 1.

[0128] The other parts of this embodiment are the same as in Embodiment 1, and will not be repeated here.

[0129] Example 3

[0130] This invention also provides an artificial valve device, which includes the radially contractile anti-reflux stent provided in any of the above embodiments. The regurgitation stent forms an installation channel. The artificial valve device also includes a cover, an artificial valve leaflet, and a leak-proof skirt. The cover is fixed to the fastener 4 and is arranged around the inner side of the radially contractile anti-reflux stent to prevent blood from leaking through the hollowed-out position of the radially contractile anti-reflux stent. The artificial valve leaflet is fixed to the cover, and the distal ends of the artificial valve leaflet are further fixedly installed on both sides of the suture portion 13 of the connector 1. That is, the edge of the distal end of the artificial valve leaflet is directly sutured through the elongated suture hole 131 without the need for additional suture pads. Compared with the traditional method of using pads and regurgitation stents to squeeze each other to fix the artificial valve leaflet, this method firstly reduces the additional components of the radially contractile anti-reflux stent. Moreover, without pads, it is also beneficial to further compress the radially contractile anti-reflux stent. If there are pads, they will not only affect the compression of the stent, but may even damage the artificial valve leaflet when the stent is compressed to a small size. The leak-proof skirt is located at the proximal end of the locking end 5 to prevent side leakage of the anti-backflow stent, which is prone to radial shrinkage.

[0131] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

Claims

1. An anti-reflux stent that facilitates radial contraction, characterized in that, include: Connectors, each of which is circumferentially spaced at the distal end of the anti-backflow support that facilitates radial contraction; The positioning element and the fastener are provided between adjacent connecting elements. The positioning element and the fastener are respectively bent toward the proximal end of the anti-backflow stent that facilitates radial contraction. In the extended state, in the radial direction of the anti-backflow stent that facilitates radial contraction, the proximal end of the positioning element is located outside its corresponding fastener. A clamping space for clamping the original leaflet is formed between the positioning element and the fastener. The locking end is zigzag-shaped and forms several V-shaped locking units with openings facing away from the distal end of the anti-backflow bracket that facilitates radial contraction. The locking unit includes a first locking unit connected to the proximal end of the fastener and a second locking unit located between adjacent first locking units. A reinforcing mesh is provided between adjacent fasteners. The reinforcing mesh is composed of two self-expanding arcs. The distal ends of the two self-expanding arcs are connected to the two adjacent fasteners in a one-to-one correspondence. The proximal ends of the two self-expanding arcs are respectively connected to the locking end. The proximal ends of the two self-expanding arcs are connected to the distal ends of the two adjacent second locking units in a one-to-one correspondence. The two self-expanding arcs are defined as a first self-expanding arc and a second self-expanding arc, and the middle parts of the first self-expanding arc and the second self-expanding arc are connected. The first self-expanding arc includes a first rod and a second rod connected in sequence, and the second self-expanding arc includes a third rod and a fourth rod. The first rod, the second rod, the third rod, and the fourth rod are connected to each other, wherein, in the extended state: The distal ends of the first rod and the fourth rod bend away from each other, while the proximal ends of the first rod and the fourth rod bend closer to each other; the degree of bending of the first rod and the fourth rod is greater than that of the second rod and the third rod.

2. The anti-reflux stent of claim 1, wherein, The proximal ends of each of the positioning units are connected sequentially to form a hollow structure; the distal end of the first positioning unit is connected to the fastener.

3. The ease of radial contraction anti-reflux stent of claim 1, wherein, Four second card slot units are provided between adjacent first card slot units.

4. The ease of radial contraction anti-reflux stent of claim 1, wherein, In the contracted state, both the first and second self-expanding arcs are straight lines, the first and second rods are of equal length, and the third and fourth rods are of equal length.

5. The ease of radially collapsing anti-reflux stent of claim 1, wherein, In the axial direction of the anti-backflow bracket that facilitates radial contraction, the fastener is divided into an upper half and a lower half. The upper half is used to connect the connector, and the proximal end of the fastener is formed on the lower half. The distal ends of the first self-expanding arc and the second self-expanding arc are connected to the upper half of the fastener.

6. The ease of radially collapsing anti-reflux stent of claim 1, wherein, The positioning element includes a first positioning arm, a second positioning arm, and a proximal end of the positioning element, wherein the first positioning arm and the second positioning arm are connected through the proximal end of the positioning element.

7. The anti-backflow support that facilitates radial contraction as described in claim 1, characterized in that, The fastener includes a first fastening arm, a second fastening arm, and a fastener proximal end connecting the first fastening arm and the second fastening arm. The first fastening arm and the second fastening arm are respectively connected to two adjacent connectors. The connector includes a positioning member connecting part, a fastener connecting part, and a sewing part. The sewing part is provided with a sewing through hole and is located between the positioning member connecting part and the fastener connecting part. The connector further includes a connecting block and a web plate, wherein the connecting block is connected to the positioning member connecting part through the web plate; The width of the web is smaller than the width of the connecting block.

8. The anti-backflow support that facilitates radial contraction as described in claim 1, characterized in that, The radially retractable anti-backflow bracket further includes a support member disposed between adjacent connectors. The two ends of the support member are connected to the two connectors in a one-to-one correspondence. The support member is bent away from the connectors, and the proximal end of the support member is closer to the connectors than the proximal end of the positioning member.

9. The anti-backflow support that facilitates radial contraction as described in claim 1, characterized in that, The anti-backflow support that facilitates radial contraction also includes a marker and a fixing member, wherein the proximal end of the fixing member is connected to the positioning member, and the marker is mounted on the fixing member.

10. The anti-backflow support for easy radial contraction as described in claim 9, characterized in that, The fixing member includes a fixing part and a limiting part. The two ends of the fixing part are respectively connected to the limiting part and the proximal end of the positioning member. The marking member is a C-shaped structure that wraps around the fixing part. The limiting part is used to prevent the marking member from detaching from the fixing part.

11. The anti-backflow support for easy radial contraction as described in claim 9, characterized in that, The fastener has a fixing hole, and the marker is fitted into the fixing hole.

12. The anti-backflow stent that facilitates radial contraction as described in any one of claims 9-11, characterized in that, The distal end of the fixing part includes a wire through hole for the wire to pass through, so as to control the degree of expansion of the positioning member.

13. An artificial valve device, characterized in that, include: The anti-backflow bracket that facilitates radial contraction as described in any one of claims 1-12, wherein the backflow bracket forms an installation channel; The film is applied and fixed to the fastener; An artificial leaflet is fixed to the membrane and the connector and sewn to the connector. The artificial leaflet is used to control the opening and closing of the installation channel. A leak-proof skirt is provided at the locking end to prevent side leakage of the anti-backflow bracket that facilitates radial contraction.

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