Heart valve stent, heart valve assembly and method of operating the same

Abstract

The present application relates to a heart valve stent, a heart valve assembly and a method for operating the same. The heart valve stent comprises a plurality of support rods arranged circumferentially, first middle connecting ends of each pair of the support rods are separated from each other and connected at both sides, the first middle connecting ends are close to first inflow side ends of the support rods and away from first outflow side ends of the support rods; a plurality of intermediate rods arranged circumferentially, second middle connecting ends of each pair of the intermediate rods are separated from each other and connected at both sides, the second middle connecting ends are away from second inflow side ends of the intermediate rods and close to second outflow side ends of the intermediate rods; a plurality of extension rods arranged circumferentially at intervals, the extension rods are connected to the second outflow side ends of two adjacent intermediate rods; and a plurality of connecting rods arranged circumferentially, each pair of the connecting rods is connected between two adjacent extension rods, and outflow side ends of each pair of the connecting rods are connected to each other. The heart valve stent is stable.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to heart valve stents, heart valve assemblies and their operation methods. Background Technology

[0002] The heart is an important organ of the human body or an organism. When a person's own heart valves are abnormal, a heart valve replacement surgery can be performed to install new heart valves.

[0003] Traditional heart valve replacement surgery is an open, highly invasive procedure with significant trauma and the need for cardiopulmonary bypass. The surgery carries high risks, including complications such as massive bleeding, infection, and arrhythmia, potentially leading to months of recovery for patients. In recent years, researchers have focused on achieving interventional catheter-based artificial heart valve replacement without opening the chest cavity or placing the patient on cardiopulmonary bypass, aiming to minimize trauma. This bioprosthetic valve can replace the patient's own valve, thus avoiding the removal of the diseased valve.

[0004] Because this bioprosthetic valve needs to be delivered via a specific delivery device through an access sheath to reach and support the patient's own valve, it must be compressed before implantation. This compression requires navigating through the smallest possible access vessel and then inflating it with a balloon inside the body. The valve stent must provide sufficient support to minimize patient trauma and enhance safety. Furthermore, if deformation, slippage, or dimensional abnormalities are found during inflating after compression, it cannot be removed and replaced without surgical intervention, thus affecting the optimal clinical outcome expected from the valve.

[0005] Furthermore, conventional valve stents often form a rhomboid structure composed of two adjacent struts. Under stress, this rhomboid structure is prone to instability and struggles to maintain its ideal shape; there is also a risk of displacement. Rhomboid and gyro-shaped structures often exhibit stress concentration and paravalvular leakage risks. Poor valve stent performance can also lead to a higher incidence of conduction block. Summary of the Invention

[0006] This application provides a cardiac valve stent, comprising: a plurality of support rods arranged circumferentially, the support rods extending in a zigzag manner along the inflow and outflow directions, the plurality of support rods including a plurality of pairs of adjacent support rods, each pair of support rods having a first middle connecting end separated from each other along the inflow and outflow directions while the two side ends are connected, the first middle connecting end being close to the first inflow side end of the support rod and away from the first outflow side end of the support rod; a plurality of intermediate rods arranged circumferentially, the intermediate rods being connected one-to-one with the first outflow side ends, the plurality of intermediate rods including a plurality of pairs of adjacent intermediate rods, each pair of intermediate rods having a second middle connecting end separated from each other along the inflow and outflow directions while the two side ends are connected separately, the second middle connecting end being away from the second inflow side end of the intermediate rod and close to the second outflow side end of the intermediate rod; a plurality of extension rods spaced apart circumferentially, the extension rods being connected to the second outflow side ends of two adjacent intermediate rods; and a plurality of connecting rods arranged circumferentially, each pair of connecting rods being connected between two adjacent extension rods, the outflow side ends of each pair of connecting rods being connected to each other.

[0007] By incorporating multiple pairs of support rods, each pair fitting snugly against the human valve annulus in a unique peach-shaped closed-loop unit structure, the radial and axial force values ​​differ during deformation of the peach-shaped structure, thus helping to prevent instability. This specific geometric configuration overcomes the stress concentration phenomenon and perivalvular leakage risk associated with rhomboid and gyro-shaped structures. Multiple intermediate rods can also form a peach-shaped structure composed of two adjacent intermediate rods, further enhancing stability.

[0008] In the heart valve stent of this embodiment, the peach-shaped structure differs from the conventional rhomboid structure. Instead, it employs bipolar anchoring at the peach-shaped apex and the X-junction, achieving better fit, increasing the contact area, and avoiding tissue damage. This not only reduces the risk of displacement but also significantly reduces the incidence of conduction block. The peach-shaped heart valve stent fits more closely to the valve annulus upon contact, reducing local stress concentration, thereby helping to reduce the risk of annular tearing and preventing stroke.

[0009] In some embodiments, the support rod includes a first rod and a second rod that are bent against each other, and the intermediate rod includes a third rod and a fourth rod that are bent against each other; the first rod, the second rod, the third rod and the fourth rod are arranged sequentially along the inflow and outflow directions; the second rod, the third rod and the fourth rod are all thinner than the connecting rod; the first rod has the same or smaller cross-sectional area as the connecting rod, and the first rod has the same or larger cross-sectional area as the thickest of the second rod, the third rod and the fourth rod.

[0010] This design ensures that the structural strength at both ends of the heart valve stent is higher than that in the middle. When the stent is supported by a balloon, the overall opening is more synchronized, helping to avoid the "dog bone" phenomenon (where the stent expands and deforms smoothly), preventing the stent's tip from puncturing the balloon and ensuring safety. The heart valve stent also has minimal impact on the left ventricular outflow tract after implantation.

[0011] In some implementations, along the inflow and outflow directions, the span H1 between the first middle connecting end and the first inflow side end and the span H2 between the first middle connecting end and the first outflow side end satisfy: 1.1≤H2 / H1≤2.

[0012] For example, along the inflow and outflow directions, the span H3 between the second middle connecting end and the second outflow side end and the span H4 between the second middle connecting end and the second inflow side end satisfy: 1.1≤H4 / H3≤2.

[0013] With this configuration, the heart-shaped closed-loop unit is composed of arc-shaped rods with specific curvature characteristics. The dimensions of the apex of the heart-shaped structure along the inflow and outflow directions are in a ratio of 1:1.1 to 1:2 to the dimensions of the base along the inflow and outflow directions. This specific geometric configuration overcomes the stress concentration phenomenon and the risk of periploidal leakage in rhomboid and gyro-shaped structures.

[0014] In addition, heart valve stents can appear as different shadows in images. Specifically, there are differences in the images at different locations along the axis, such as the connecting end and the non-connecting end. This layered pattern along the axis can be used as a release marker, which helps to confirm the position of the heart valve stent relative to the heart and facilitates the precise configuration of the supravalvular and subvalvular ratios.

[0015] In some implementations, the support rod and the intermediate rod are symmetrical in shape.

[0016] With this configuration, the four peach-shaped structures form a rhombus, ensuring overall stability of the support and middle sections. Consequently, the deformation process of the heart valve stent is more balanced, and its support performance is stable during expansion.

[0017] In some embodiments, adjacent support rods, adjacent intermediate rods, and adjacent connecting rods are connected by corresponding connecting parts, which extend circumferentially; the first inflow end, the first middle connecting end, the first outflow end, the second inflow end, the second middle connecting end, the second outflow end, and the third outflow end of the connecting rod all extend in the inflow and outflow direction.

[0018] With this design, the connecting part can pull the connected part to deform, and the deformation force and support force are balanced; the size of the heart valve stent in the compressed state is small, and the force is stable when deformed.

[0019] In some embodiments, the plurality of extension rods includes an extension mounting rod with mounting holes; at the same extension mounting rod, the distance between the ends of two intermediate rods is less than the distance between the ends of two connecting rods.

[0020] With this configuration, the extension rod is used to connect the leaflets, and its proper position allows it to maintain its posture when the heart valve stent deforms. The difference in the configuration between the connecting rod and the intermediate rod helps maintain the overall shape of the heart valve stent.

[0021] In some implementations, at least one pair of intermediate rods are circumferentially offset from at least one pair of corresponding connecting rods and aligned circumferentially with at least one pair of corresponding support rods.

[0022] This design allows the new imbalance between the connecting section and the intermediate section to counteract the imbalance caused by the extended mounting rod in the heart valve stent, which is beneficial to the overall stability of the heart valve stent after compression and expansion.

[0023] In some embodiments, the number of extension rods is twelve, and the plurality of extension rods includes three extension mounting rods evenly distributed circumferentially.

[0024] This design results in a simple heart valve stent structure, small size in the compressed state, and good strength in the expanded state; it can effectively connect the valve leaflets.

[0025] This application also provides a heart valve assembly, which includes: the aforementioned heart valve stent; leaflets disposed within the heart valve stent; and a skirt connected to a plurality of support rods and connected to the leaflets.

[0026] By installing heart valve stents, the heart valve assembly can be stably compressed and expanded, reliably maintaining the shape of the valve leaflets.

[0027] This application also provides a method for operating a heart valve stent, based on the aforementioned heart valve stent or the aforementioned heart valve assembly, the method comprising: radially compressing the heart valve stent to reduce the outer diameter of the heart valve stent; or using an airbag to inflate the heart valve stent in the compressed state to increase the outer diameter of the heart valve stent.

[0028] The method for manipulating a heart valve stent disclosed in this application enables the heart valve stent to be deformed, placing it in a favorable compressed state or a favorable expanded state. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of a heart valve stent according to one or more embodiments;

[0030] Figure 2 A schematic isometric view of a cardiac valve stent according to one or more embodiments;

[0031] Figure 3 This is a structural schematic diagram of a support rod, intermediate rod, extension rod, connecting rod, and connecting part according to one or more embodiments;

[0032] Figure 4 A schematic diagram of the deployment of a cardiac valve stent according to one or more embodiments;

[0033] Figure 5 A schematic top view of a cardiac valve stent according to one or more embodiments;

[0034] Figure 6 A schematic front view of a heart valve assembly according to one or more embodiments;

[0035] Figure 7 This is a schematic flowchart of a method for operating a heart valve stent according to one or more embodiments.

[0036] Explanation of reference numerals in the attached drawings: 1. Support rod; 11. First rod; 12. Second rod; 111. First inflow side end; 112. Fourth outflow side end; 10. First middle connecting end; 121. Fourth inflow side end; 122. First outflow side end; 101. First support rod; 102. Second support rod; 103. Third support rod; 104. Fourth support rod;

[0037] 2. Intermediate rod; 21. Third rod; 22. Fourth rod; 211. Second inflow side end; 20. Second middle connection end; 212. Fifth outflow side end; 221. Fifth inflow side end; 222. Second outflow side end; 201. First intermediate rod; 202. Second intermediate rod; 203. Third intermediate rod; 204. Fourth intermediate rod; 205. Fifth intermediate rod;

[0038] 3. Extension rod; 301. First extension rod; 302. Second extension rod; 303. Third extension rod; 4. Connecting rod; 41. Third inflow side end; 42. Third outflow side end; 401. First connecting rod; 402. Second connecting rod; 403. Third connecting rod; 404. Fourth connecting rod; 405. Fifth connecting rod; 5. Connecting part;

[0039] 100. Heart valve stent; 110. Support segment; 1110. First ring; 1120. Second ring; 120. Intermediate segment; 1210. Third ring; 1220. Fourth ring; 130. Extension segment; 140. Connecting segment; 200. Leaflet; 300. Skirt; 400. Heart valve assembly. Detailed Implementation

[0040] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0041] In the description of this application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., indicating the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, are only for the convenience of describing this application 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, and therefore should not be construed as a limitation of this application.

[0042] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0043] Furthermore, the terms "first," "second," and "third," 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 as "first" or "second" may explicitly or implicitly include at least one of that feature. For example, a first support rod may also be referred to as a third support rod, and a third support rod may also be referred to as a first support rod. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0044] In this application, unless otherwise expressly specified and limited, the terms "connected," "linked," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; a flexible connection or a rigid connection along at least one direction; a mechanical connection or an electrical connection; a direct connection or an indirect connection through an intermediate medium, or a direct connection with an intermediate medium present; and they can also refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. The terms "installed," "set," "fixed," etc., can be broadly understood as connection. For those skilled in the art, the specific meaning of the above terms in this application can be understood according to the specific circumstances.

[0045] It should be noted that, in this application, the terms "distal" and "proximal" are used with the operator as the reference point. The end closer to the operator is called the proximal end or proximal portion, and the end farther from the operator is called the distal end or distal portion. The side facing the operator is called the proximal side or proximal side, and the side away from the operator is called the distal side or distal side. In addition, "distal direction" and "proximal direction" represent two directions; the proximal-distal direction is parallel to the distal direction and the proximal direction, and the proximal-distal direction does not specifically refer to forward or reverse directions.

[0046] For ease of description, a spatial rectangular coordinate system XYZ is established, where the positive direction of the Z-axis can be the direction from the inflow side to the outflow side, also known as the inflow and outflow direction.

[0047] refer to Figure 1 , Figure 1 A heart valve stent according to this application is shown. In an exemplary embodiment, the heart valve stent 100 includes a support segment 110, an intermediate segment 120, an extension segment 130, and a connecting segment 140. The support segment 110, intermediate segment 120, extension segment 130, and connecting segment 140 may be arranged sequentially along the positive Z-axis.

[0048] The heart valve stent 100 can be compressed or expanded. (Combined) Figure 2 As shown, the expanded heart valve stent 100 can be approximately cylindrical in shape, with its axial direction parallel to the Z-axis and its radial and circumferential directions in the XY plane; the heart valve stent 100 is generally mesh-like. The material of the heart valve stent 100 can be metal, such as a biocompatible metal; or it can be a polymer material, the strength of which is greater than the strength of the material of the valve leaflet 200 to be installed.

[0049] Combination Figure 3 and Figure 4 As shown, Figure 3 The structure of a portion of the heart valve stent 100 is shown in the figure; Figure 4 The diagram shows a portion of a heart valve stent 100 unfolded, such as a third of a circumference. The heart valve stent 100 may comprise only four segments. Exemplarily, the support segment 110 and the intermediate segment 120 may be substantially equal in length and longer than the extension segment 130 and the connecting segment 140. The outer diameter of each segment may be substantially the same; the radial wall thickness of each segment may be substantially the same or different.

[0050] The support section 110 includes a plurality of support rods 1 arranged circumferentially. (Reference) Figure 4The support section 110 includes a first support rod 101, a second support rod 102, a third support rod 103 and a fourth support rod 104. The first support rod 101 and the second support rod 102 can be a pair of support rods 1. The third support rod 103 and one of the support rods 1 on the right side of the figure are a pair of support rods 1. The fourth support rod 104 and one of the support rods 1 on the left side of the figure are a pair of support rods 1.

[0051] On one hand, each pair of support rods 1 can have a roughly X-shaped structure. Specifically, the middle connecting ends of each pair of support rods 1 along the inflow and outflow directions are connected to each other, while the two side ends are separated. The middle connecting end of the support rod 1 can be a first middle connecting end 10, and the two side ends of the support rod 1 are a first inflow side end 111 and a first outflow side end 122, respectively. The first middle connecting end 10 of the first support rod 101 is connected to the first middle connecting end 10 of the second support rod 102; the first inflow side end 111 of the first support rod 101 is separated from the first inflow side end 111 of the second support rod 102; and the first outflow side end 122 of the first support rod 101 is separated from the first outflow side end 122 of the second support rod 102.

[0052] On the other hand, the first support rod 101 and the fourth support rod 104 can also be regarded as a pair of support rods 1, and the second support rod 102 and the third support rod 103 can also be regarded as a pair of support rods 1. With this arrangement, the pair of first support rods 101 and the fourth support rod 104 and the pair of second support rods 102 and the third support rod 103 can each have a roughly peach-shaped structure. For example, the first inflow end 111 of the second support rod 102 is connected to the first inflow end 111 of its adjacent third support rod 103, and the two first middle connecting ends 10 are separated; the first outflow end 122 of the second support rod 102 is connected to the first outflow end 122 of its adjacent third support rod 103.

[0053] Furthermore, the support segment 110 may include a first ring 1110 and a second ring 1120. (See reference) Figure 3 The support rod 1 extends in a bend, and includes a first rod 11 and a second rod 12 that are bent towards each other. The first rod 11 may include a fourth outflow end 112, and the second rod 12 may include a fourth inflow end 121. The fourth outflow end 112 and the fourth inflow end 121 are used to form a first central connection end 10.

[0054] The intermediate section 120 includes multiple pairs of intermediate rods 2 arranged circumferentially. Each intermediate rod 2 is connected to a support rod 1 in a one-to-one correspondence, and their cross-sectional shapes may be the same or different. Each pair of intermediate rods 2 can be correspondingly arranged with a pair of support rods 1. For example, the first intermediate rod 201 and the second intermediate rod 202 corresponding to the first support rod 101 and the second support rod 102 may also have a generally X-shaped structure. On the other hand, the first intermediate rod 201 and the fourth intermediate rod 204 corresponding to the first support rod 101 and the fourth support rod 104 may also have a generally peach-shaped structure, and the second intermediate rod 202 and the third intermediate rod 203 may also have a generally peach-shaped structure.

[0055] The intermediate rod 2 includes a second inflow side end 211, a second middle connecting end 20, and a second outflow side end 222 arranged sequentially along the inflow and outflow directions. In a pair of intermediate rods 2 with an X-shaped structure, the two second middle connecting ends 20 are connected to each other, the two second inflow side ends 211 are separated, and the two second outflow side ends 222 are separated. For each intermediate rod 2, the second middle connecting end 20 is connected to the second middle connecting end 20 of an adjacent intermediate rod 2, the second inflow side end 211 is connected to the second inflow side end 211 of another adjacent intermediate rod 2, and the second outflow side end 222 is connected to the second outflow side end 222 of that other intermediate rod 2.

[0056] Furthermore, the intermediate segment 120 may include a third ring 1210 and a fourth ring 1220. (See reference) Figure 3 The intermediate rod 2 extends in a bend, and then includes a third rod 21 and a fourth rod 22 that are bent towards each other. The third rod 21 may include a fifth outflow side end 212, and the fourth rod 22 may include a fifth inflow side end 221. The fifth outflow side end 212 and the fifth inflow side end 221 are used to form a second central connection end 20.

[0057] The extension section 130 includes a plurality of extension rods 3 spaced circumferentially. The extension rods 3 extend in the inflow and outflow directions, and within the extension section 130, the extension rods 3 may not be connected to each other. The extension rods 3 are connected to two adjacent intermediate rods 2; exemplarily, one extension rod 3 is connected to two intermediate rods 2 that constitute the peach-shaped structure.

[0058] The connecting section 140 includes multiple pairs of connecting rods 4 arranged circumferentially. The multiple connecting rods 4 of the connecting section 140 include a first connecting rod 401, a second connecting rod 402, a third connecting rod 403, and a fourth connecting rod 404. On one hand, the first connecting rod 401 and the second connecting rod 402 can be a pair of connecting rods 4, and the fourth connecting rod 404 can be another pair of connecting rods 4 with the connecting rod 4 to its left. Each pair of connecting rods 4 is connected between two adjacent extension rods 3, and the outflow ends of each pair of connecting rods 4 are interconnected. For example, the third outflow end 42 of the first connecting rod 401 is interconnected with the third outflow end 42 of the second connecting rod 402. On the other hand, the third inflow end 41 of the first connecting rod 401 is connected to one extension rod 3, and the third inflow end 41 of the second connecting rod 402 is connected to another extension rod 3.

[0059] On the other hand, the fourth connecting rod 404 and the first connecting rod 401 form a pair of connecting rods 4, and the second connecting rod 402 and the third connecting rod 403 form another pair of connecting rods 4. In this way, the third inflow side end 41 of the pair of connecting rods 4 is connected to the same extension rod 3, and the two third outflow side ends 42 are separated.

[0060] Connecting segment 140 can also be considered as a fifth ring. Along the Z-axis, the dimensions of the first ring 1110, the fourth ring 1220, and connecting segment 140 can be approximately the same; while the dimensions of the second ring 1120 and the third ring 1210 can be approximately the same. Specifically, the lengths of the first rod 11, the fourth rod 22, and the connecting rod 4 are approximately the same, and the lengths of the second rod 12 and the third rod 21 are approximately the same.

[0061] The connecting segment 140, in conjunction with the extension rod 3 and the fourth rod 22, adopts an asymmetrical hexagonal honeycomb layout. This means the staggered arrangement of the connecting segment 140 and the heart-shaped unit form a honeycomb-like deformation buffer structure, reducing the stent recoil rate while generating a unique bistable effect during in vivo expansion. This makes it less prone to deformation and exhibits good rigidity and flexibility. The connecting segment 140 and the first ring 1110 can be the two ends of the cardiac valve stent 100, respectively. For example... Figure 5 An axial projection of the heart valve stent 100 at one end where the connecting segment 140 is located is shown.

[0062] Combination Figure 6As shown, this application provides a heart valve assembly 400, which includes a heart valve stent 100, leaflets 200, and a skirt 300. The heart valve stent 100 is the aforementioned heart valve stent. The leaflets 200 are disposed within the heart valve stent 100 and may include multiple parts capable of expanding or closing together. The leaflets 200 may be bioprosthetic valves, polymer valves, or leaflets made of other materials. The skirt 300 is connected to the support section 110 and to the leaflets 200. The heart valve stent 100 maintains stability under compression, during expansion, and after anchoring. By providing the heart valve stent 100, the heart valve assembly 400 can be stably compressed and expanded, reliably maintaining the shape of the leaflets 200.

[0063] During the implantation of the heart valve assembly 400, the heart valve stent 100 can be compressed to a smaller radial dimension and then delivered to the heart via a minimally invasive procedure, specifically with the inflow side distal and the outflow side proximal, i.e., with the support segment 110 in front. After the support segment 110 reaches the valve annulus of the heart, the heart valve stent 100 is expanded. The basic ratio of balloon-expanded valve replacement release position is 0% to 50%, for example, supravalvular to subvalvular ratio of 7 / 3, 8 / 2, or 9 / 1, with the standard position being 20%. Approximately taking the first middle connecting end 10 of the support rod 1 as a reference, clinically, except in special cases, the interval of ±10% along the Z-axis corresponds to the human valve annulus. By setting multiple pairs of support rods 1, each pair of support rods 1 conforming to the human valve annulus in a roughly X-shaped structure, good radial support force can be ensured, achieving safe anchoring.

[0064] In an exemplary embodiment, the dimension of the first ring 1110 along the Z-axis is 5% to 40% of the total dimension of the heart valve stent 100.

[0065] Once expanded, the 100 heart valve stent conforms well to the heart. The physical dimensions and expanded state dimensions of the 100 heart valve stent can be determined based on individual patient conditions such as the degree of calcification and cardiac anatomy. Due to its good anchoring force, the 100 heart valve stent does not require excessive oversize for anchoring during clinical use, which helps reduce the incidence of conduction block, the risk of annular tearing, and prevents stroke caused by dislodgement from calcification sites, thus helping to prevent stroke.

[0066] In some embodiments, the second rod 12, the third rod 21, and the fourth rod 22 are all thinner than the connecting rod 4. The second rod 12, the third rod 21, and the fourth rod 22 may have the same cross-sectional area and the same cross-sectional shape, or they may be slightly different. The first rod 11 has the same or smaller cross-sectional area as the connecting rod 4, and the first rod 11 has the same or larger cross-sectional area than the thickest of the second rod 12, the third rod 21, and the fourth rod 22. The extension rod 3 may also be thicker than the intermediate rod 2. When the cross-section of the first rod 11 and the cross-section of the intermediate rod 2 are both rectangular, their radial dimensions (thickness) along the heart valve stent 100 can be the same, and therefore the first rod 11 may be wider than the intermediate rod 2 and the second rod 12. The cross-sections of the support rod 1, the intermediate rod 2, and other rods may also be approximately circular or rounded rectangular. The first rod 11 and connecting rod 4 are relatively thick. The structural strength of the first ring 1110 and connecting segment 140 is higher than that of the second ring 1120, the third ring 1210, and the fourth ring 1220. When the heart valve stent 100 is inflated by the balloon, the overall opening state is more synchronized, which helps to avoid the "dog bone" phenomenon. The expansion and deformation of the heart valve stent 100 is smooth, which helps to prevent puncturing the balloon and ensure safety. The heart valve stent 100 has little impact on the left ventricular outflow tract after implantation.

[0067] For example, along the Z-axis, in support rod 1, the first middle connecting end 10 is located near the first inflow side end 111, and the first middle connecting end 10 is located away from the first outflow side end 122; in intermediate rod 2, the second middle connecting end 20 is located away from the second inflow side end 211, and the second middle connecting end 20 is located near the second outflow side end 222. Specifically, the first rod 11 is shorter than the second rod 12, and the third rod 21 is longer than the fourth rod 22. A peach-shaped structure composed of two adjacent support rods 1 can be formed in support section 110, and a peach-shaped structure composed of two adjacent intermediate rods 2 can be formed in intermediate section 120.

[0068] refer to Figure 3 and Figure 4 For the peach-shaped structure formed by the support rod 1, the first outflow side end 122 is the apex of the peach heart, and the first inflow side end 111 is the end of the base.

[0069] Along the inflow and outflow directions, the span H1 between the first middle connecting end 10 and the first inflow side end 111, and the span H2 between the first middle connecting end 10 and the first outflow side end 122, satisfy: 1.1 ≤ H2 / H1 ≤ 2. For example, this ratio is 1.2, 1.5, or 1.8. The heart-shaped closed-loop unit is composed of arc-shaped rods with specific curvature characteristics. The dimension of the apex of the heart-shaped structure along the inflow and outflow directions and the dimension of the base along the inflow and outflow directions satisfy a ratio of 1:1.1 to 1:2. This specific geometric configuration overcomes the stress concentration phenomenon and the risk of periploidal leakage in rhomboid and gyro-shaped structures.

[0070] Along the inflow and outflow directions, the span H3 between the second middle connecting end 20 and the second outflow side end 222, and the span H4 between the second middle connecting end 20 and the second inflow side end 211, satisfy the following condition: 1.1 ≤ H4 / H3 ≤ 2. For example, this ratio is 1.2, 1.5, or 1.8.

[0071] The two peach-shaped structures arranged along the Z-axis can be symmetrical. Unlike the symmetrical rhomboid structure, the radial and axial force values ​​differ when the peach-shaped structure deforms, which helps to avoid instability. On the other hand, the X-shaped structure formed in the support section 110 and the X-shaped structure formed in the middle section 120 can also be symmetrical.

[0072] Furthermore, the heart valve stent 100 can present shadows of varying densities in images. Along the axial direction, different locations will show variations in the image; for example, adjacent pairs from the first intermediate connecting end 10, the second rod 12, the connection 5 between the support rod 1 and the intermediate rod 2, the third rod 21 to the second intermediate connecting end 20 will differ. The first intermediate connecting end 10 and the second intermediate connecting end 20 can serve as release markers. Identifying the offset positions of these two points in the support segment 110 and the intermediate segment 120 helps confirm the position of the heart valve stent 100 relative to the heart, facilitating precise configuration of the supravalvular / subvalvular ratio. The heart-shaped apex serves as a dual-marker system; the specific apex spacing forms a scale bar. The heart-shaped unit presents a bimodal waveform under fluoroscopy, distinct from the single-peak signal of a rhombus, and can form unique imaging points, keeping release errors within a small range.

[0073] In some embodiments, adjacent support rods 1, adjacent intermediate rods 2, and adjacent connecting rods 4 are connected by corresponding connecting portions 5. Adjacent support rods 1 have a certain distance between them, and the connecting portion 5 extends circumferentially and connects the two support rods 1. Adjacent intermediate rods 2 and adjacent connecting rods 4 also have a certain distance between them. Providing connecting portions 5 ensures that the structures of the support rods 1, intermediate rods 2, and connecting rods 4 are relatively complete, and that the deformation force and supporting force are balanced. The connecting portion 5 can guide the deformation of the connected parts and also ensures the connection strength.

[0074] The first inflow end 111, the first middle connecting end 10, the first outflow end 122, the second inflow end 211, the second middle connecting end 20, the second outflow end 222, the third inflow end 41, and the third outflow end 42 can all extend in the inflow and outflow directions. When the heart valve stent 100 is in the compressed state, the support rod 1, the intermediate rod 2, and the connecting rod 4 can have a generally straight shape that is nearly parallel to the extension rod 3. The heart valve stent 100 is small in size when compressed, and the support section 110, the intermediate section 120, and the connecting section 140 deform when expanded, and the force is stable during deformation.

[0075] In some embodiments, the shapes of the support rod 1 and the intermediate rod 2 are symmetrical. Each pair of support rods 1 can be symmetrical in shape, and each pair of intermediate rods 2 can be symmetrical in shape. For example, the fourth support rod 104 to the third support rod 103, and the corresponding fourth intermediate rod 204 to the third intermediate rod 203 form four peach-shaped structures, with a rhombus formed between the four peach-shaped structures. The support segment 110 and the intermediate segment 120 are generally stable, resulting in a balanced deformation process for the heart valve stent 100 and stable support performance in the expanded state.

[0076] In some embodiments, the plurality of extension rods 3 include an extension mounting rod with mounting holes, such as Figure 4 The first extension rod 301 is designed as an extension mounting rod. The extension mounting rod is used to connect the leaflet 200. The extension mounting rod is positioned appropriately so that it can maintain a posture that is basically parallel to the Z-axis direction when the heart valve stent 100 deforms.

[0077] At the same extension mounting rod, for example Figure 4 At the first extension rod 301, the distance between the ends of the two intermediate rods 2, i.e., the distance between the two second outflow ends 222, is relatively close, while the distance between the ends of the two connecting rods 4, i.e., the distance between the two third inflow ends 41, is relatively far. The difference in the arrangement of the connecting rods 4 and the intermediate rods 2 is beneficial to maintaining the overall shape of the heart valve stent 100.

[0078] In some embodiments, at least one pair of intermediate rods 2 are circumferentially offset from at least one pair of corresponding connecting rods 4 and aligned circumferentially with at least one pair of corresponding support rods 1. For example... Figure 4 As shown, the pair of support rods 1, the first support rod 101 and the second support rod 102, are aligned with the corresponding first intermediate rod 201 and the second intermediate rod 202 along the Z-axis direction, and there is no misalignment along the circumferential direction; however, the pair of connecting rods 4, the first connecting rod 401 and the second connecting rod 402, are not aligned with the corresponding first intermediate rod 201 and the second intermediate rod 202, but are offset and misaligned along the circumferential direction, as shown in the figure. Figure 4 The image is slightly to the left.

[0079] For example, based on Figure 4 The second extension rod 302 on the left side of the first extension rod 301 has a large overlap with the third inflow end 41 of the first connecting rod 401 and the second extension rod 302. The third inflow end 41 of the fourth connecting rod 404 has a small overlap with the second extension rod 302. It can even be connected to the left side of the second extension rod 302 or connected to the second extension rod 302 through the connecting part 5. The two intermediate rods 2 on the lower side have a similar degree of overlap with the extension rod 3, and the two intermediate rods 2 can be slightly offset to the right.

[0080] For example, the first extension rod 301 is substantially rectangular in shape and may have a plane of symmetry parallel to the Z-axis direction. Based on the first extension rod 301, the second intermediate rod 202 and the third intermediate rod 203 are substantially symmetrical and may be symmetrical with respect to the plane of symmetry of the first extension rod 301. The second connecting rod 402 and the third connecting rod 403 may also be symmetrical with respect to the plane of symmetry of the first extension rod 301.

[0081] For example, a fifth connecting rod 405 may be located between the third extension rod 303 and the fourth connecting rod 404, and a fifth intermediate rod 205 may be located between the third extension rod 303 and the fourth intermediate rod 204. The fifth connecting rod 405 and the fifth intermediate rod 205 may be arranged asymmetrically. For example, along the circumferential direction, the fifth connecting rod 405 may be shorter, while the fifth intermediate rod 205 may be longer.

[0082] Based on two adjacent extension rods 3, such as the first extension rod 301 and the second extension rod 302, along with the fourth rod 22 of the first intermediate rod 201, the fourth rod 22 of the second intermediate rod 202, the first connecting rod 401, and the second connecting rod 402, six rods form a hexagonal structure. To address the imbalance in the heart valve stent 100 caused by the first extension rod 301 designed as an extension mounting rod, the added imbalance between the connecting segment 140 and the intermediate segment 120 can mutually cancel each other out. The offset misalignment of the connecting rod 4 is beneficial to the overall stability of the heart valve stent 100 after compression and expansion. The hexagonal structure is unbalanced, but its inflow side is a symmetrical peach-shaped structure, which also helps to improve stability.

[0083] For example, in the entire heart valve stent 100, the support rod 1 is the inflow end and the connecting rod 4 is the outflow end. Then, a pair of connecting portions 5 at the first inflow side ends 111 are smoothly connected between these two first inflow side ends 111 to close the peach-shaped structure; a pair of connecting portions 5 at the third outflow side ends 42 are smoothly connected between these two third outflow side ends 42 to close the hexagonal structure. The circumferential dimensions of each connecting portion 5 may vary slightly to accommodate the designed eccentric layout.

[0084] Combination Figure 1 , Figure 2 and Figure 5 As shown, in some embodiments, the number of extension rods 3 is twelve, and the plurality of extension rods 3 includes three extension mounting rods evenly distributed circumferentially, with a central angle of 120° between two adjacent extension mounting rods. The heart valve stent 100 has a simple structure, small size in the compressed state, and good strength in the expanded state; it can effectively connect the leaflet 200. In other embodiments, the number of extension rods 3 may also be other, such as ten, eleven, thirteen, fourteen, etc.; the number of corresponding support rods 1, intermediate rods 2, and connecting rods 4 is also adjusted. For example, fifteen extension rods 3 correspond to thirty, or fifteen pairs, of connecting rods 4.

[0085] refer to Figure 7 This application also provides a method 1000 for operating a heart valve stent. The steps of the method 1000 for operating a heart valve stent can be performed during the manufacture of the heart valve stent 100, the manufacture of the heart valve assembly 400, the inspection of the heart valve stent 100, or the inspection of the heart valve assembly 400.

[0086] For example, a method 1000 for operating a heart valve stent includes step S110, radially compressing the heart valve stent 100 to reduce the outer diameter of the heart valve stent 100.

[0087] For example, a method 1000 for operating a heart valve stent includes step S120, which involves using a balloon to inflate a compressed heart valve stent 100, thereby increasing the outer diameter of the heart valve stent 100. Optionally, step S110 may be performed before step S120; step S120 may also be performed before step S110.

[0088] The method 1000 for manipulating a heart valve stent of this application enables the heart valve stent 100 to deform into a favorable compressed state or a favorable expanded state. The compressed heart valve stent 100 or heart valve assembly 400 is small in size and easy to store and transport. The expanded heart valve stent 100 is easy to assemble and allows for functional verification or use.

[0089] The method of this application utilizes a heart valve stent 100. The heart-shaped unit achieves significant improvement through a two-stage anchoring mechanism. The first-stage anchoring achieves anatomical fit by matching the curvature of the heart apex with the valve annulus tissue, increasing the contact area. The second-stage anchoring utilizes the progressive embedding of the X-shaped intersection to avoid tissue damage and effectively reduce the risk of displacement.

[0090] The technical features of the above-disclosed 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.

[0091] In the embodiments disclosed above, unless otherwise explicitly specified and limited, the execution order of each step is not restricted. For example, they can be executed in parallel or sequentially in different orders. The sub-steps of each step can also be executed alternately. Various forms of processes described above can be used, and steps can be reordered, added, or deleted, as long as the desired result of the technical solution provided in this application can be achieved, and this application does not impose any restrictions here.

[0092] The embodiments disclosed above merely illustrate 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 patent protection of this application. 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 scope of patent protection claimed by this application. Therefore, the scope of patent protection of this application should be determined by the appended claims.

Claims

1. A heart valve stent, characterized in that, include: Multiple support rods are arranged circumferentially, and the support rods extend in a zigzag manner along the inflow and outflow direction. The multiple support rods include multiple pairs of adjacent support rods. The first middle connecting end of each pair of support rods along the inflow and outflow direction is separated from each other while the two side ends are connected. The first middle connecting end is close to the first inflow side end of the support rod and far away from the first outflow side end of the support rod. A plurality of intermediate rods are arranged along the circumferential direction, and the intermediate rods are connected one-to-one with the first outflow side end. The plurality of intermediate rods include a plurality of pairs of adjacent intermediate rods. The second middle connecting end of each pair of intermediate rods along the inflow and outflow direction is separated from each other, while the two side ends are connected and separated. The second middle connecting end is away from the second inflow side end of the intermediate rod and close to the second outflow side end of the intermediate rod. A plurality of extension rods are arranged at circumferential intervals, the extension rods being connected to the second outflow side ends of two adjacent intermediate rods; as well as Multiple connecting rods are arranged circumferentially, with each pair of connecting rods connected between two adjacent extension rods, and the outflow ends of each pair of connecting rods are connected to each other.

2. The cardiac valve stent according to claim 1, characterized in that, The support rod includes a first rod and a second rod that are bent at each other, and the intermediate rod includes a third rod and a fourth rod that are bent at each other; the first rod, the second rod, the third rod and the fourth rod are arranged sequentially along the inflow and outflow directions; The second rod, the third rod, and the fourth rod are all thinner than the connecting rod; The first rod has the same or smaller cross-sectional area as the connecting rod, and the first rod has the same or larger cross-sectional area as the thickest of the second, third, and fourth rods.

3. The cardiac valve stent according to claim 1, characterized in that, Along the inflow and outflow directions, the span H1 between the first middle connecting end and the first inflow side end and the span H2 between the first middle connecting end and the first outflow side end satisfy: 1.1≤H2 / H1≤2, and the span H3 between the second middle connecting end and the second outflow side end and the span H4 between the second middle connecting end and the second inflow side end satisfy: 1.1≤H4 / H3≤2.

4. The cardiac valve stent according to claim 1, characterized in that, The support rod and the intermediate rod are symmetrical in shape.

5. The cardiac valve stent according to claim 1, characterized in that, Adjacent support rods, adjacent intermediate rods, and adjacent connecting rods are connected by corresponding connecting parts, which extend along the circumferential direction. The first inflow end, the first middle connecting end, the first outflow end, the second inflow end, the second middle connecting end, the second outflow end, and the third outflow end of the connecting rod all extend along the inflow and outflow direction.

6. The cardiac valve stent according to any one of claims 1 to 5, characterized in that, The plurality of extension rods includes an extension mounting rod with mounting holes; At the same extension mounting rod, the distance between the ends of the two intermediate rods is less than the distance between the ends of the two connecting rods.

7. The cardiac valve stent according to claim 6, characterized in that, At least one pair of the intermediate rods and the corresponding at least one pair of connecting rods are offset and misaligned along the circumferential direction, and are aligned with the corresponding at least one pair of support rods along the circumferential direction.

8. The cardiac valve stent according to claim 6, characterized in that, The number of extension rods is twelve, and the plurality of extension rods includes three extension mounting rods evenly distributed along the circumference.

9. A heart valve assembly, characterized in that, include: Heart valve stent as described in any one of claims 1 to 8; Leaflets are disposed within the cardiac valve stent; as well as The skirt is connected to the plurality of support rods and to the petals.

10. A method for operating a heart valve stent, based on a heart valve stent as described in any one of claims 1 to 8 or a heart valve assembly as described in claim 9, characterized in that, The method includes: The heart valve stent is compressed radially to reduce its outer diameter; or An airbag is used to support the heart valve stent in a compressed state, thereby increasing the outer diameter of the heart valve stent.

Images