Heart valve stent, heart valve assembly and method of operation thereof

Abstract

The invention relates to a heart valve stent, a heart valve assembly and a method of operating the same. The heart valve stent comprises a plurality of supporting rods arranged in the circumferential direction, first middle connecting ends, in the inflow and outflow direction, of each pair of supporting rods are separated from each other, the two side ends of each pair of supporting rods are connected, and the first middle connecting ends are close to the first inflow side ends of the supporting rods and far away from the first outflow side ends of the supporting rods; the second middle connecting ends, in the inflow and outflow direction, of each pair of middle rods are separated from each other, the two side ends of each pair of middle rods are connected and separated, and the second middle connecting ends are away from the second inflow side ends of the middle rods and close to the second outflow side ends of the middle rods; the extension rods are arranged at intervals in the circumferential direction, and the extension rods are connected to the second outflow side ends of every two adjacent middle rods; the connecting rods are arranged in the circumferential direction, each pair of connecting rods is connected between every two adjacent extension rods, and the outflow side ends of each pair of connecting rods are connected with each other. The heart valve stent is stable.

Description

Technical Field

[0001] The present application relates to the technical field of medical supplies, and particularly to a heart valve stent, a heart valve assembly and an operation method thereof. Background Art

[0002] The heart is an important organ of the human body or an organism. When the heart valve of its own is abnormal, a new heart valve can be installed through a heart valve replacement surgery.

[0003] Traditional heart valve replacement surgery is an open and highly invasive treatment. The surgical trauma is large and extracorporeal circulation is required. The surgical risk is very high, and adverse reactions such as massive bleeding, infection, and arrhythmia are likely to occur during the surgery, resulting in the patient possibly taking up to several months to recover. In recent years, researchers have been committed to realizing interventional catheter artificial heart valve replacement without opening the chest cavity or placing the patient on extracorporeal circulation, aiming to minimize the trauma. This biological valve can pass through the patient's own valve for replacement, thus avoiding resection of the diseased valve of the patient.

[0004] Since this biological valve needs to reach its own valve through a specific delivery device via an access sheath and be supported on the patient's own valve, before implantation, this biological valve needs to be compressed, pass through the smallest possible access blood vessel, and then be expanded in the body using a balloon. The valve stent needs to have sufficient supporting force to minimize the patient's trauma and improve safety. In addition, if deformation is found after compression and expansion in the body, or slippage or size abnormality occurs during expansion, it cannot be removed and replaced again except by surgical technical means, which will affect the best effect that the clinical expected valve can achieve at this time.

[0005] In addition, a rhombic structure formed by two adjacent struts will be formed in a conventional valve stent. When stressed, the rhombic structure of this valve stent is very likely to become unstable and it is difficult to maintain an ideal shape; there is also a risk of displacement. The rhombic structure and the gyroscopic structure often have stress concentration phenomena and the risk of paravalvular leakage. Poor performance of the valve stent may also result in a high incidence of conduction block. Summary of the Invention

[0006] The present application provides a heart valve stent, which includes: 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 multiple pairs of adjacent support rods, the first middle connection ends of each pair of support rods along the inflow and outflow directions being separated from each other while the two side ends are connected, the first middle connection end being close to the first inflow side end of the support rod and far from the first outflow side end of the support rod; a plurality of intermediate rods arranged circumferentially, the intermediate rods being connected to the first outflow side ends one by one, the plurality of intermediate rods including multiple pairs of adjacent intermediate rods, the second middle connection ends of each pair of intermediate rods along the inflow and outflow directions being separated from each other while the two side ends are connected and separated, the second middle connection end being far 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 arranged at intervals 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, and the outflow side ends of each pair of connecting rods being connected to each other.

[0007] By providing multiple pairs of support rods, each pair of support rods fits the human valve annulus with a unique peach-shaped closed-loop unit structure. When the peach-shaped structure deforms, the radial force value and the axial force value are different, which is beneficial to avoid instability. This specific geometric configuration overcomes the stress concentration phenomenon of the diamond structure and the gyro structure and the risk of paravalvular leakage. Multiple intermediate rods can also form a peach-shaped structure composed of two adjacent intermediate rods, improving stability.

[0008] In the heart valve stent according to the embodiment of the present application, the peach-shaped structure is different from the conventional diamond structure, and adopts bipolar anchoring at the peach-shaped top and the X junction to achieve better fitting, increase the contact area, and avoid tissue damage at the same time. It not only reduces the displacement risk, but also significantly reduces the incidence of conduction block. The heart valve stent with a peach-shaped structure is more fitting when contacting the valve annulus, reduces local stress concentration, which is beneficial to reducing the risk of valve annulus tear and preventing stroke.

[0009] In some embodiments, the support rod includes a first rod and a second rod that are deflected from each other, and the intermediate rod includes a third rod and a fourth rod that are deflected from each other; the first rod, the second rod, the third rod, and the fourth rod are arranged in sequence 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 compared with the connecting rod, and the first rod has the same or larger cross-sectional area compared with the thickest one of the second rod, the third rod, and the fourth rod.

[0010] With such a setting, the structural strength at both ends of the heart valve stent is higher than that in the middle. When the heart valve stent is inflated by a balloon, the overall opening state is relatively synchronous, which is beneficial to avoiding the dog-bone phenomenon. The heart valve stent expands and deforms smoothly, which helps to avoid the tip piercing the balloon and ensures safety. The heart valve stent has little impact on the left ventricular outflow tract after implantation.

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

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

[0013] In this way, the heart-shaped closed-loop unit is composed of arc-shaped rods with specific curvature characteristics, and the dimensions of the vertex of the peach-shaped structure along the inflow and outflow directions and the dimensions of the base along the inflow and outflow directions meet the ratio of 1:1.1 to 1:2. This specific geometric configuration overcomes the stress concentration phenomenon and paravalvular leakage risk of the diamond structure and gyro-shaped structure.

[0014] In addition, the heart valve stent can present different shadows in the image. Specifically, there are differences in the image at different positions along the axial direction, such as the connection end and the non-connection end. Therefore, the layered pattern along the axial direction can be used as a release mark, which helps to confirm the position of the heart valve stent relative to the heart and is conducive to the precise configuration of the ratio of the valve above and below the valve.

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

[0016] With such an arrangement, a diamond shape is formed between the four peach-shaped structures, the support segment and the middle segment are stable as a whole, and the deformation process of the heart valve stent is relatively balanced, and the support performance in the expanded state is stable.

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

[0018] With such arrangement, the connection part can pull the connected part to deform, and the deformation force is balanced with the supporting force; the size of the heart valve stent in the compressed state is small, and the force is stable during deformation.

[0019] In some embodiments, the plurality of extension rods include an extension mounting rod having a mounting hole; at the same extension mounting rod, the distance between the ends of the two middle rods is smaller than the distance between the ends of the two connecting rods.

[0020] With such arrangement, the extended mounting rod is used to connect the leaflets, and its position is appropriate. When the heart valve stent is deformed, the extended mounting rod can maintain its posture; the difference in the arrangement of the connecting rod and the intermediate rod is beneficial to maintaining the overall shape of the heart valve stent.

[0021] In some embodiments, at least one pair of intermediate rods is offset and misaligned with the corresponding at least one pair of connecting rods in the circumferential direction, and is aligned with the corresponding at least one pair of supporting rods in the circumferential direction.

[0022] With such arrangement, the newly added imbalance of the connecting section and the middle section can offset each other for the imbalance of the heart valve stent caused by the extended mounting rod, which is beneficial to the overall stability of the heart valve stent after compression and expansion.

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

[0024] With such arrangement, the heart valve stent has a simple structure, a small size in a compressed state, and good strength in an expanded state; and can effectively connect the valve leaflets.

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

[0026] By providing a heart valve stent, the heart valve component can be stably compressed and expanded, and the shape of the valve leaflets can be reliably maintained.

[0027] The present 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 includes: compressing the heart valve stent radially to reduce the outer diameter of the heart valve stent; or using an airbag to prop up the heart valve stent in a compressed state to increase the outer diameter of the heart valve stent.

[0028] The method for operating a heart valve stent of the present application can deform the heart valve stent to place it in a favorable compressed state or a favorable expanded state. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0030] Figure 2 is a schematic axonometric view of a heart valve stent according to one or more embodiments;

[0031] Figure 3 A schematic diagram of the structure of a support rod, an intermediate rod, an extension rod, a connecting rod and a connecting portion according to one or more embodiments;

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

[0033] Figure 5 Schematic top view of a heart valve stent according to one or more embodiments;

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

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

[0036] Description of reference numerals: 1, support rod; 11, first rod; 12, second rod; 111, first inflow side end; 112, fourth outflow side end; 10, first middle connection 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, middle 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 middle rod; 202, second middle rod; 203, third middle rod; 204, fourth middle rod; 205, fifth middle 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, connection part;

[0039] 100, heart valve stent; 110, support section; 1110, first ring; 1120, second ring; 120, middle section; 1210, third ring; 1220, fourth ring; 130, extension section; 140, connection section; 200, valve leaf; 300, skirt; 400, heart valve assembly. Detailed implementation manners

[0040] To make the above objects, features and advantages of the present application more obvious and understandable, the following will describe the detailed implementation manners of the present application with reference to the accompanying drawings. Many specific details are set forth in the following description in order to fully understand the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present application. Therefore, the present application is not limited by the specific embodiments of the disclosed implementation manners below.

[0041] In the description of the present application, it should be understood that the orientation or positional relationships indicated by the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "perpendicular", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. are based on the orientation or positional relationships shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to the present application.

[0042] In the present application, unless otherwise clearly specified and limited, the first feature being "on" or "under" the second feature may be that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on top of" the second feature may be that the first feature is directly above or obliquely above the second feature, or merely indicates that the first feature has a higher horizontal height than the second feature. The first feature being "under", "beneath" and "underneath" the second feature may be that the first feature is directly below or obliquely below the second feature, or merely indicates that the first feature has a lower horizontal height than the second feature.

[0043] In addition, the terms "first", "second", "third", etc. are only used for descriptive purposes, and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined as "first" and "second" may explicitly or implicitly include at least one of such features. Exemplarily, the first support rod may also be referred to as the third support rod, and the third support rod may also be referred to as the first support rod. In the description of the present application, the meaning of "a plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0044] In the present application, unless otherwise clearly specified and limited, the terms "connected" and "coupled" should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a flexible connection, or a rigid connection along at least one direction; it may be a mechanical connection, or an electrical connection; it may be directly connected, or indirectly connected through an intermediate medium, or directly connected while there is an intermediate medium, and may also be the internal communication of two elements or the interaction relationship between two elements, unless otherwise clearly limited. The terms "installed", "set", "fixed", etc. can be understood in a broad sense as connection. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific circumstances.

[0045] It should be noted that in this application, the so-called distal end and proximal end are based on the operator. The end close to the operator is the proximal end or proximal part, and the end far from the operator is the distal end or distal part. The side facing the operator is the proximal side or proximal side, and the side facing away from the operator is the distal side or distal side. In addition, the distal direction and the 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 the positive or negative direction.

[0046] For convenience of description, a three-dimensional 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-outflow direction.

[0047] Reference Figure 1 , Figure 1 shows the heart valve stent in this application. In an exemplary embodiment, the heart valve stent 100 includes a support section 110, an intermediate section 120, an extension section 130, and a connection section 140. The support section 110, the intermediate section 120, the extension section 130, and the connection section 140 can be arranged in sequence along the positive direction of the Z axis.

[0048] The heart valve stent 100 can be compressed or expanded. As shown in Figure 2 , the heart valve stent 100 in the expanded state can be generally cylindrical in structure, with its axis parallel to the Z axis direction, and its radial and circumferential directions in the XY plane; the heart valve stent 100 is a mesh as a whole. The material of the heart valve stent 100 can be metal, such as a metal compatible with the human body; or the material is a polymer material, and the strength of the polymer material is greater than the strength of the material of the leaflet 200 to be installed.

[0049] As shown in Figure 3 and Figure 4 , Figure 3 shows the structure of a part of the heart valve stent 100; Figure 4 shows the structure of a part of the heart valve stent 100 being unfolded, such as a part of one-third of the circumference. The heart valve stent 100 can only include four sections. Exemplarily, the support section 110 and the intermediate section 120 can be substantially of equal length and longer than the extension section 130 and the connection section 140. The outer diameter dimensions of each section can be substantially the same; the wall thickness of each section along the radial direction can be substantially the same or different.

[0050] The support section 110 includes a plurality of support rods 1 arranged circumferentially. Refer to Figure 4, among the multiple support rods 1 of the support section 110, there are 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 a support rod 1 on its right side in the figure are a pair of support rods 1, and the fourth support rod 104 and a support rod 1 on its left side in the figure are a pair of support rods 1.

[0051] On the one hand, each pair of support rods 1 can have a generally X-shaped configuration. Specifically, the middle connection 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 connection end of the support rod 1 can be the first middle connection end 10, and the two side ends of the support rod 1 are respectively the first inflow side end 111 and the first outflow side end 122. The first middle connection end 10 of the first support rod 101 is connected to the first middle connection 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; 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 then the second support rod 102 and the third support rod 103 can also be regarded as a pair of support rods 1. With such an arrangement, the pair of the first support rod 101 and the fourth support rod 104 and the pair of the second support rod 102 and the third support rod 103 can respectively have a generally peach-shaped configuration. For example, the first inflow side end 111 of the second support rod 102 is connected to the first inflow side end 111 of the adjacent third support rod 103, and the two first middle connection ends 10 are separated; the first outflow side end 122 of the second support rod 102 is connected to the first outflow side end 122 of the adjacent third support rod 103.

[0053] Furthermore, the support section 110 can include a first ring 1110 and a second ring 1120. Refer to Figure 3 , the support rod 1 extends in a zigzag manner, and then the support rod 1 includes a first rod 11 and a second rod 12 that are deflected from each other. The first rod 11 can include a fourth outflow side end 112, and the second rod 12 can include a fourth inflow side end 121. The fourth outflow side end 112 and the fourth inflow side end 121 are used to form the first middle connection end 10.

[0054] The middle section 120 includes multiple pairs of middle rods 2 arranged circumferentially. The middle rods 2 are connected to the support rods 1 in a one-to-one correspondence, and their cross-sectional shapes may be the same or different. Each pair of middle rods 2 can be correspondingly arranged with a pair of support rods 1. Exemplarily, the first middle rod 201 and the second middle 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 middle rod 201 and the fourth middle 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 middle rod 202 and the third middle rod 203 may also have a generally peach-shaped structure.

[0055] The middle rod 2 includes a second inflow-side end 211, a second middle connection end 20, and a second outflow-side end 222 arranged in sequence along the inflow-outflow direction. In a pair of middle rods 2 with an X-shaped structure, the two second middle connection 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 middle rod 2, the second middle connection end 20 is connected to the second middle connection end 20 of an adjacent middle rod 2, the second inflow-side end 211 is connected to the second inflow-side end 211 of another adjacent middle rod 2, and the second outflow-side end 222 is connected to the second outflow-side end 222 of the other middle rod 2.

[0056] Further, the middle section 120 may include a third ring 1210 and a fourth ring 1220. Refer to Figure 3 , the middle rod 2 extends in a zigzag manner. Then, the middle rod 2 includes a third rod 21 and a fourth rod 22 that are deflected from 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 the second middle connection end 20.

[0057] The extension section 130 includes multiple extension rods 3 arranged at intervals circumferentially. The extension rods 3 extend along the inflow-outflow direction, 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 middle rods 2. Exemplarily, one extension rod 3 is connected to two middle rods 2 that form a 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 the 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 a pair of connecting rods 4 with the connecting rod 4 on its left. Each pair of connecting rods 4 divided in this way is connected between two adjacent extension rods 3, and the outflow-side ends of each pair of connecting rods 4 are connected to each other. For example, the third outflow-side end 42 of the first connecting rod 401 is connected to the third outflow-side end 42 of the second connecting rod 402. In addition, the third inflow-side end 41 of the first connecting rod 401 is connected to one extension rod 3, and the third inflow-side 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 are a pair of connecting rods 4, and the second connecting rod 402 and the third connecting rod 403 are another pair of connecting rods 4. The third inflow-side ends 41 of such a pair of connecting rods 4 are connected to the same extension rod 3, and the two third outflow-side ends 42 are separated.

[0060] The connecting section 140 can also be regarded as the fifth ring. Along the Z-axis direction, the sizes of the first ring 1110, the fourth ring 1220, and the connecting section 140 can be substantially the same; while the sizes of the second ring 1120 and the third ring 1210 can be substantially the same. Specifically, the lengths of the first rod 11, the fourth rod 22, and the connecting rod 4 are substantially the same, and the lengths of the second rod 12 and the third rod 21 are substantially the same.

[0061] The connecting section 140 cooperates with the extension rod 3 and the fourth rod 22 to adopt an asymmetric hexagonal honeycomb layout, that is, the connecting section 140 is misaligned and forms a honeycomb-shaped deformation buffer structure with the heart-shaped unit. While reducing the stent recoil rate, it produces a unique bistable effect during in-vivo expansion, is not easily deformed, and has good rigidity and flexibility. The connecting section 140 and the first ring 1110 can be the two ends of the heart valve stent 100 respectively. For example Figure 5 The axial projection view of the heart valve stent 100 at the end where the connecting section 140 is located is shown.

[0062] Combined Figure 6As shown, an embodiment of the present application provides a heart valve assembly 400, which includes a heart valve stent 100, valve leaflets 200 and a skirt 300. The heart valve stent 100 is the aforementioned heart valve stent 100. The valve leaflets 200 are disposed within the heart valve stent 100 and may include multiple parts that can expand or gather and close with each other. The valve leaflets 200 can be biological valve leaflets, polymer valve leaflets or valve leaflets made of other materials. The skirt 300 is connected to the support section 110 and to the valve leaflets 200. The heart valve stent 100 can ensure stability in the compressed state, during the expansion process and after the anchoring operation. By providing the heart valve stent 100, the heart valve assembly 400 can be stably compressed and expanded, and can reliably maintain the shape of the valve leaflets 200.

[0063] When implanting the heart valve assembly 400, the heart valve stent 100 can be compressed into a compressed state with a smaller radial dimension, and then through minimally invasive surgery, it can be sent to the heart along the blood vessel. Specifically, the inflow side is the distal side and the outflow side is the proximal side, that is, it is transported in the way that the support section 110 is in the front. After the support section 110 reaches the annulus position of the heart, the heart valve stent 100 is expanded into an expanded state. The basic release position ratio of balloon-expandable valve replacement is 0% to 50%. For example, the ratio of above the valve to below the valve is 7 / 3, 8 / 2 or 9 / 1, and the standard position is 20%. Approximately with the first middle connection end 10 of the support rod 1 as a reference, in clinical practice except for special cases, the interval of plus or minus 10% in the Z-axis direction corresponds to the human annulus. By providing multiple pairs of support rods 1, each pair of support rods 1 fits the human annulus in a roughly X-shaped structure, which can ensure good radial support force and can achieve safe anchoring.

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

[0065] After the heart valve stent 100 is expanded, it can fit well with the heart. The physical size and the expanded state size of the heart valve stent 100 can be determined according to the individual conditions of the patient, such as the degree of calcification and the cardiac anatomical structure. Due to good anchoring force, when clinically using the heart valve stent 100, there is no need for excessive oversize for anchoring, which is beneficial to reducing the incidence of conduction block, beneficial to reducing the risk of annulus tear, beneficial to preventing stroke caused by the detachment at the calcification site, and beneficial to preventing 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 may be slightly different. The first rod 11 has the same or smaller cross-sectional area compared to the connecting rod 4, and the first rod 11 has the same or larger cross-sectional area compared to the thickest one 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-sections of the first rod 11 and the intermediate rod 2 are both rectangular, their dimensions along the radial direction of the heart valve stent 100, i.e., the thickness, may be the same, and then the first rod 11 may be wider than the intermediate rod 2 and the second rod 12. The cross-sections of each rod such as the support rod 1 and the intermediate rod 2 may also be approximately circular or a rounded rectangle, etc. The first rod 11 and the connecting rod 4 are thicker, and the structural strength of the first ring 1110 and the connecting section 140 can be higher than that of the second ring 1120, the third ring 1210, and the fourth ring 1220. When the heart valve stent 100 is expanded by the balloon, the overall opening state is relatively synchronous, which is beneficial to avoiding the "dog bone" phenomenon. The heart valve stent 100 expands and deforms smoothly, which helps to prevent puncturing the balloon and ensures safety. The heart valve stent 100 has little impact on the left ventricular outflow tract after implantation.

[0067] Exemplarily, along the Z-axis direction, in the support rod 1, the position of the first middle connection end 10 is close to the first inflow side end 111, and the position of the first middle connection end 10 is far from the first outflow side end 122; in the intermediate rod 2, the position of the second middle connection end 20 is far from the second inflow side end 211, and the position of the second middle connection end 20 is close to 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 formed by two adjacent support rods 1 can be formed in the support section 110, and a peach-shaped structure formed by two adjacent intermediate rods 2 can be formed in the intermediate section 120.

[0068] Reference 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 part.

[0069] Along the inflow and outflow directions, the span H1 between the first middle connection end 10 and the first inflow side end 111 and the span H2 between the first middle connection 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 peach-shaped closed-loop unit is composed of arc-shaped rods with specific curvature characteristics. The dimension of the apex part of the peach-shaped structure along the inflow and outflow directions and the dimension of the base part along the inflow and outflow directions satisfy the ratio of 1:1.1 to 1:2. This specific geometric configuration overcomes the stress concentration phenomenon and the risk of paravalvular leakage of the diamond structure and the gyro structure.

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

[0071] The two peach-shaped structures arranged along the Z-axis direction can be symmetrical. The peach-shaped structure is different from the symmetrical diamond structure. When the peach-shaped structure is deformed, the radial force value is different from the axial force value, which is conducive to avoiding 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] In addition, the heart valve stent 100 can present shadows of different densities in the image. Along the axial direction, different positions in the image will have different changes, for example, from the first middle connecting end 10, the second rod 12, the connecting portion 5 between the support rod 1 and the middle rod 2, the third rod 21 to the second middle connecting end 20, each adjacent two places will be different. The first middle connecting end 10 and the second middle connecting end 20 can be used as release marks. By identifying the offset positions of these two places in the support segment 110 and the middle segment 120, it is helpful to confirm the position of the heart valve stent 100 relative to the heart, which is conducive to accurately configuring the proportion of the upper and lower valves. The heart vertex is used as a double marking system, and the special vertex spacing forms a scale. The heart unit presents a double-peak waveform under perspective, which is different from the single-peak signal of the rhombus, and can form a unique development point to control the release error within a smaller range.

[0073] In some embodiments, two adjacent support rods 1, two adjacent intermediate rods 2, and two adjacent connecting rods 4 are connected by corresponding connecting parts 5. Two adjacent support rods 1 have a certain spacing, and the connecting part 5 extends along the circumferential direction and connects the two support rods 1. Two adjacent intermediate rods 2 and two adjacent connecting rods 4 also have a certain spacing. The connecting part 5 is provided to make the structures of the support rods 1, the intermediate rods 2, and the connecting rods 4 more complete, and the deformation force and the supporting force are balanced. The connecting part 5 can pull the connected part to deform, and can also ensure the connection strength.

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

[0075] In some embodiments, the shapes of the support rods 1 and the intermediate rods 2 are symmetric. The shapes of each pair of support rods 1 can be symmetric, and the shapes of each pair of intermediate rods 2 can be symmetric. 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, and a rhombus is formed between the four peach-shaped structures. The support section 110 and the intermediate section 120 are stable as a whole, and then the deformation process of the heart valve stent 100 is balanced, and the support performance in the expanded state is stable.

[0076] In some embodiments, among the plurality of extension rods 3, there is an extension mounting rod provided with a mounting hole, such as Figure 4 the first extension rod 301 in is designed as an extension mounting rod. The extension mounting rod is used to connect the leaflets 200. The position of the extension mounting rod is appropriate, and when the heart valve stent 100 is deformed, the extension mounting rod can maintain a posture substantially parallel to the Z-axis direction.

[0077] At the same extension mounting rod, for example Figure 4 at the first extension rod 301 of, the distance between the ends of the two intermediate rods 2, that is, the distance between the two second outflow side ends 222, is relatively close, while the distance between the ends of the two connecting rods 4, that is, the distance between the two third inflow side ends 41, is relatively far. The difference in the arrangement of the connecting rod 4 and the intermediate rod 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 and the corresponding at least one pair of connecting rods 4 are circumferentially offset and misaligned, and are circumferentially aligned with the corresponding at least one pair of support rods 1. Such as Figure 4 shown, the pair of support rods 1, namely the first support rod 101 and the second support rod 102, are aligned with the corresponding first intermediate rod 201 and second intermediate rod 202 in the Z-axis direction and are not misaligned circumferentially; while the pair of connecting rods 4, namely the first connecting rod 401 and the second connecting rod 402, are not aligned with the corresponding first intermediate rod 201 and second intermediate rod 202, but are circumferentially offset and misaligned, as Figure 4 shown to be offset to the left.

[0079] Exemplarily, based on Figure 4 the second extension rod 302 on the left side of the first extension rod 301 in, the coincidence dimension of the third inflow side end 41 of the first connecting rod 401 and the second extension rod 302 is relatively large, and the coincidence dimension of the third inflow side end 41 of the fourth connecting rod 404 and the second extension rod 302 is relatively small or even can be connected to the left side of the second extension rod 302 or connected to the second extension rod 302 through the connecting portion 5. The coincidence degree of the two intermediate rods 2 on the lower side with the extension rod 3 is quite the same, and the two intermediate rods 2 can be slightly offset to the right.

[0080] Exemplarily, the first extension rod 301 is substantially rectangular in shape and may have a pair of symmetry planes 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 symmetric and may be symmetric with respect to the symmetry plane of the first extension rod 301. The second connecting rod 402 and the third connecting rod 403 may also be symmetric with respect to the symmetry plane of the first extension rod 301.

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

[0082] Based on two adjacent extension rods 3, such as the first extension rod 301 and the second extension rod 302, cooperating 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. For the imbalance of the heart valve stent 100 caused by the first extension rod 301 designed as an extended mounting rod, the new imbalance between the connecting section 140 and the intermediate section 120 can offset each other, and 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 symmetric peach-shaped structure, which also helps to improve stability.

[0083] Exemplarily, in the entire heart valve stent 100, the support rod 1 is the inflow end and the connecting rod 4 is the outflow end. Subsequently, the connecting portions 5 at a pair of first inflow side ends 111 are smoothly connected between this pair of first inflow side ends 111 for closing the peach-shaped structure; the connecting portions 5 at a pair of third outflow side ends 42 are smoothly connected between this pair of third outflow side ends 42 for closing the hexagonal structure. The circumferential dimensions of each connecting portion 5 may vary slightly to adapt to the eccentric layouts designed at various places.

[0084] Combined 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 extended mounting rods evenly distributed along the circumferential direction, and the central angle between two adjacent extended mounting rods is 120°. The heart valve stent 100 has a simple structure, a small size in the compressed state, and good strength in the expanded state; it can effectively connect the leaflets 200. In other embodiments, the extension rod 3 may also have other numbers, such as ten, eleven, thirteen, fourteen, etc.; the corresponding numbers of the support rods 1, intermediate rods 2 and connecting rods 4 are also adjusted. For example, fifteen extension rods 3 correspond to thirty, that is, fifteen pairs of connecting rods 4.

[0085] Reference Figure 7 Figure 7 The present application also provides a method 1000 for operating a heart valve stent. The steps of the method 1000 for operating a heart valve stent may be performed during the manufacturing of the heart valve stent 100, the manufacturing of the heart valve assembly 400, the inspection of the heart valve stent 100, or the inspection of the heart valve assembly 400.

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

[0087] Exemplarily, the method 1000 for operating a heart valve stent includes step S120 of using an airbag to expand the compressed heart valve stent 100 to increase the outer diameter of the heart valve stent 100. Optionally, step S110 may be performed before step S120; step S120 may also have been performed before step S110.

[0088] The method 1000 for operating a heart valve stent of the present application can deform the heart valve stent 100 to make it in a favorable compressed state or a favorable expanded state. The compressed heart valve stent 100 or the 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 can verify the function or be used.

[0089] The method of the embodiment of the present application utilizes the heart valve stent 100. The heart-shaped unit has achieved great improvement through a two-stage anchoring mechanism. The first-stage anchoring realizes anatomical fitting by matching the curvature of the heart-shaped apex with the annulus tissue, increasing the contact area. The second-stage anchoring uses the progressive embedding of the X-shaped intersection to avoid tissue damage and effectively reduces the displacement risk.

[0090] The technical features of the above-disclosed embodiments can be combined arbitrarily. For the sake of brevity of description, 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, it should be considered as the scope recorded in this specification.

[0091] In the above-disclosed embodiments, unless otherwise clearly specified and limited, the execution order of each step is not limited. For example, they can be executed in parallel or sequentially in a different order. The sub-steps of each step can also be executed alternately. Various forms of the process can be used, and steps can also be reordered, added, or deleted, as long as the desired results of the technical solutions provided by the present application can be achieved. The present application does not limit this here.

[0092] The embodiments disclosed above only represent several implementation manners of the present application. The description thereof is relatively specific and detailed, but it should not be construed as a limitation on the patent protection scope of the present application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several deformations and improvements can still be made, and these all belong to the patent protection scope required by the present application. Therefore, the patent protection scope of the present application shall be subject to the appended claims.

Claims

1. Heart valve stent, characterized in that, Comprising: A plurality of support rods arranged circumferentially, the support rods extending in a zigzag manner along the inflow and outflow direction, the plurality of support rods including multiple pairs of adjacent support rods, and for each pair of the support rods, the first middle connection ends along the inflow and outflow direction are separated from each other while the two side ends are connected, and the first middle connection ends are close to the first inflow side ends of the support rods and far from the first outflow side ends of the support rods; A plurality of intermediate rods arranged along the circumferential direction, the intermediate rods being connected to the first outflow side ends in a one-to-one correspondence, the plurality of intermediate rods including multiple pairs of adjacent intermediate rods, and for each pair of the intermediate rods, the second middle connection ends along the inflow and outflow direction are separated from each other while the two side ends are connected and separated, and the second middle connection ends are far from the second inflow side ends of the intermediate rods and close to the second outflow side ends of the intermediate rods; A plurality of extension rods arranged at intervals along the circumferential direction, the extension rods being connected to the second outflow side ends of two adjacent intermediate rods; And A plurality of connecting rods arranged along the circumferential direction, and for each pair of the connecting rods, they are connected between two adjacent extension rods, and the outflow side ends of each pair of the connecting rods are connected to each other.

2. The heart valve stent according to claim 1, characterized in that, The support rod includes a first rod and a second rod that are deflected from each other, and the intermediate rod includes a third rod and a fourth rod that are deflected from each other; the first rod, the second rod, the third rod, and the fourth rod are arranged in sequence along the inflow and outflow direction; 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 compared to the connecting rod, and the first rod has the same or larger cross-sectional area compared to the thickest one of the second rod, the third rod, and the fourth rod.

3. The heart valve stent according to claim 1, wherein Along the inflow and outflow direction, the span H1 between the first middle connection end and the first inflow side end and the span H2 between the first middle connection end and the first outflow side end satisfy: 1.1 ≤ H2 / H1 ≤ 2, and the span H3 between the second middle connection end and the second outflow side end and the span H4 between the second middle connection end and the second inflow side end satisfy: 1.1 ≤ H4 / H3 ≤ 2.

4. The heart valve stent according to claim 1, wherein The shapes of the support rod and the intermediate rod are symmetrical.

5. The heart valve stent according to claim 1, characterized in that, Adjacent two support rods, adjacent two intermediate rods, and adjacent two connecting rods are respectively connected through corresponding connection parts, and the connection parts extend along the circumferential direction; The first inflow side end, the first middle connection end, the first outflow side end, the second inflow side end, the second middle connection end, the second outflow side end, and the third outflow side end of the connecting rod all extend along the inflow and outflow direction.

6. The heart valve stent according to any one of claims 1 to 5, characterized in that, Among the plurality of extension rods, there is an extension installation rod provided with an installation hole; At the same extension installation rod, the end distance between the two intermediate rods is less than the end distance between the two connecting rods.

7. The heart valve stent according to claim 6, wherein, At least one pair of the intermediate rods and the corresponding at least one pair of connecting rods are offset circumferentially and are circumferentially aligned with the corresponding at least one pair of support rods.

8. The heart valve stent according to claim 6, characterized in that, The number of the extension rods is twelve, and the plurality of extension rods include three extension installation rods evenly distributed along the circumferential direction.

9. A heart valve assembly, characterized in that, Comprising: The heart valve stent according to any one of claims 1 to 8; Leaflets, disposed within the heart valve stent; And A skirt, connected to the plurality of support struts and connected to the leaflets.

10. A method for operating a heart valve stent, based on the heart valve stent according to any one of claims 1 to 8 or the heart valve assembly according to claim 9, characterized in that, The method includes: Radially compressing the heart valve stent to reduce the outer diameter of the heart valve stent; or Using an airbag to expand the compressed heart valve stent to increase the outer diameter of the heart valve stent.

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