A heart valve stent and an artificial heart valve

Abstract

This disclosure relates to cardiac valve stents and artificial heart valves. The cardiac valve stent is a radially contractible and expandable annular frame, comprising an inflow end, an outflow end, and connecting components. The inflow end includes multiple first support frames arranged circumferentially at intervals, each first support frame including two waist connecting ends and two spaced-apart top connecting ends. The outflow end includes multiple second support frames arranged circumferentially at intervals, each second support frame including two spaced-apart bottom connecting ends. Each first support frame is correspondingly connected to one second support frame, and the two bottom connecting ends are respectively connected to the two top connecting ends, forming two spaced-apart connection points. The connecting components include multiple first connecting rods and multiple second connecting rods. The two ends of each first connecting rod are respectively connected to the waist connecting ends of adjacent first support frames; the two ends of each second connecting rod are respectively connected to the two connection points. This enhances radial support force and achieves a balance between radial support force and compressibility.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to the technical field of medical devices, and particularly relates to a heart valve stent and an artificial heart valve. BACKGROUND

[0002] Heart valves grow between atrium and ventricle, ventricle and aorta, and play the role of one-way valve to help blood flow in one direction. If the heart valve is diseased, it will affect the movement of blood flow, thereby causing abnormal heart function and eventually leading to heart failure. Therefore, when the autologous heart valve is damaged, abnormal or inoperable, heart valve replacement surgery must be performed.

[0003] Traditional heart valve replacement is an open high-invasive treatment, and the surgical trauma is large and needs extracorporeal circulation. The surgical risk is very high, and during the operation, it is easy to cause adverse reactions such as massive hemorrhage, infection, arrhythmia, etc., which leads to the fact that the patient needs to recover for several months.

[0004] In recent years, researchers have been committed to performing interventional catheter artificial heart valve replacement without opening the chest cavity or placing the patient in extracorporeal circulation, striving to minimize trauma, so that the biological valve can pass through the patient's own valve to be placed, thereby avoiding the removal of the patient's diseased valve.

[0005] The balloon-expandable valve is usually composed of a heart valve stent and an artificial valve. The balloon-expandable valve needs to be compressed before implantation, and then expanded by a specific delivery device through an access sheath to the patient's own valve and then supported on the patient's own valve. Therefore, the balloon-expandable valve not only needs to pass through the smallest access blood vessel, but also needs sufficient support after the valve stent is expanded, so as to minimize patient trauma and safety. However, the existing heart valve stent is directly connected by rods, and it is difficult to balance the radial support force and the compressibility, and it is difficult to anchor with the patient's own valve. SUMMARY

[0006] Therefore, it is necessary to provide a heart valve stent and an artificial heart valve, which can balance the radial support force and the compressibility, and facilitate the anchoring with the patient's own valve.

[0007] The application provides a heart valve stent, which is a radially contractible and expandable annular frame. The heart valve stent comprises an inflow end, an outflow end and a connecting assembly. The inflow end comprises a plurality of first support frames, which are sequentially and circumferentially arranged at intervals. Each first support frame comprises two waist connecting ends and two spaced top connecting ends. The outflow end comprises a plurality of second support frames, which are sequentially arranged circumferentially. Each second support frame comprises two spaced bottom connecting ends. Each first support frame is connected to a second support frame. The two bottom connecting ends are connected to the two top connecting ends respectively and form two spaced connecting points. The connecting assembly comprises a plurality of first connecting rods and a plurality of second connecting rods. The two ends of each first connecting rod are connected to the waist connecting ends of adjacent first support frames respectively. The two ends of each second connecting rod are connected to the two connecting points respectively.

[0008] When the heart valve stent expands radially, the first connecting rods connect the first support frames, the second connecting rods connect the inflow end and the outflow end, and the first connecting rods and the second connecting rods jointly act to reduce the number of the first support frames and the second support frames forming the annular frame, so that the heart valve stent can be compressed to a smaller size. The annular structure formed by the first connecting rods after compression can be anchored to the patient's own valve. When the heart valve stent expands, the first connecting rods and the second connecting rods significantly enhance the radial support force, realize the balance between the radial support force and the compression, and ensure the structural stability of the heart valve stent after contraction and expansion.

[0009] In some embodiments, the heart valve stent has an expansion state and a contraction state in which the radial dimension of the outflow end is greater than the radial dimension of the inflow end.

[0010] In this way, the heart valve stent in the expansion state is in a micro-horn shape, which can better control the expected size of the artificial valve and further ensure the hemodynamics, so that the blood flow passes through the heart valve stent more smoothly.

[0011] In some embodiments, the first support frame further comprises two waist support rods, a bottom connecting rod and two bottom support rods. Each waist support rod is connected to a bottom support rod and forms a waist connecting end. The two waist support rods form two spaced top connecting ends. The two ends of the bottom connecting rod are connected to the bottom ends of the two bottom support rods respectively.

[0012] In this way, the bottom connecting rod is in the shape of a horizontal bar and has a certain length in the circumferential direction. The bottom connecting rod in the contracted heart valve stent is closer to a circle, which greatly reduces the risk of scratching the blood vessel.

[0013] In some embodiments, the axial dimension of the waist support rod is greater than the axial dimension of the bottom support rod.

[0014] In this way, the first support frame is a quadrilateral grid and has a large axial dimension, which reduces the material of the first support frame while the axial dimension of the heart valve stent remains unchanged. Under the same crimping deformation condition, the first support frame can be compressed to a smaller size.

[0015] In some embodiments, the second support frame comprises a hexagonal frame, the hexagonal frame comprises two upper inclined rods, two lower inclined rods, two longitudinal rods, and a top connecting rod, two ends of the top connecting rod are connected to the top ends of the two upper inclined rods, the bottom end of each upper inclined rod and the top end of each lower inclined rod are connected to the two ends of a longitudinal rod, respectively, and the two lower inclined rods form two spaced bottom connecting ends.

[0016] In this way, the hexagonal frame is connected in sequence so that the outflow end is more sparse relative to the inflow end, the radial support force of the outflow end is smaller than that of the inflow end, and the radial dimension of the outflow end is larger than that of the inflow end when the balloon is expanded, which better reduces the impact of the artificial valve on the left and right coronary arteries and provides sufficient space for intraoperative coronary protection and release of a coronary stent.

[0017] In some embodiments, the ratio of the distance between the first connecting rod and the bottom connecting rod to the distance between the top connecting rod and the bottom connecting rod ranges from 5% to 40%.

[0018] In this way, the first connecting rod provides support at the middle and lower positions of the heart valve stent for anchoring with the patient's own valve, significantly enhances the radial support force without increasing the density of the heart valve stent, improves the safety and accuracy of anchoring, and reduces the incidence of conduction block.

[0019] In some embodiments, every 120° along the circumference, the longitudinal rods of two adjacent second support frames enclose a fixing hole.

[0020] In this way, the fixing hole facilitates the connection and fixation of the artificial valve to the heart valve stent.

[0021] In some embodiments, the top connecting rod and the second connecting rod are designed to be eccentrically asymmetric along the axial direction.

[0022] In this way, the eccentrically asymmetric design of the top connecting rod and the second connecting rod prevents the heart valve stent from being skewed when changing from the expanded state to the contracted state.

[0023] In some embodiments, the two adjacent second support frames are connected eccentrically asymmetrically along the axial direction.

[0024] The eccentrically asymmetric design of the fixing hole, the top connecting rod, and the second connecting rod makes the heart valve stent unbalanced. Therefore, the eccentrically asymmetric design of the second support frame integrates the aforementioned unbalance to maintain the overall balance and ensure the stability of the heart valve stent after compression and expansion.

[0025] The application provides an artificial heart valve, which comprises the heart valve support, the artificial valve and the polymer skirt.

[0026] The artificial heart valve provided by the application is connected with the polymer skirt through the heart valve support and is implanted in the body to be anchored with the native valve. The heart valve support can be compressed to a smaller size when being contracted, so as to reduce the risk of scratching the blood vessel, increase the radial support force and balance, ensure the stability of the heart valve support after being expanded and ensure the smooth blood flow of the artificial heart valve. BRIEF DESCRIPTION OF DRAWINGS

[0027] Figure 1 FIG. 1 is a schematic diagram of the heart valve support in the embodiment of the present application;

[0028] Figure 2 FIG. 2 is an enlarged view of the structure at A in FIG. 1; Figure 1

[0029] Figure 3 FIG. 3 is an enlarged view of the structure at B in FIG. 1; Figure 1

[0030] FIG. 4 is a schematic diagram of the heart valve support in the contracted state in the embodiment of the present application; Figure 4

[0031] FIG. 5 is a schematic diagram of the heart valve support in the expanded state in the embodiment of the present application; Figure 5

[0032] FIG. 6 is a schematic diagram of the structure of the artificial heart valve in the embodiment of the present application. Figure 6 LIST OF REFERENCE NUMERALS

[0033] 100, artificial heart valve; 10, heart valve support; 1, inflow end; 11, first support frame; 111, waist connecting end; 112, waist support rod; 1121, top connecting end; 113, bottom connecting rod; 114, bottom support rod; 2, outflow end; 21, second support frame; 211, lower inclined rod; 2111, bottom connecting end; 212, vertical rod; 213, upper inclined rod; 214, top connecting rod; 22, fixing hole; 3, connecting point; 4, connecting assembly; 41, first connecting rod; 42, second connecting rod; 20, artificial valve; 30, polymer skirt.

[0034] DETAILED DESCRIPTION ​​

[0035] In order to make the above objectives, characteristics and advantages of the embodiments of the present disclosure more obvious and understandable, specific embodiments of the embodiments of the present disclosure will be described in detail below with reference to the drawings. In the following description, a lot of specific details are set forth in order to provide a thorough understanding of the embodiments of the present disclosure. However, the embodiments of the present disclosure can be implemented in many different ways from those described herein, and those skilled in the art can make similar improvements without departing from the spirit of the embodiments of the present disclosure, and therefore the embodiments of the present disclosure are not limited to the specific examples disclosed below.

[0036] In the description of the embodiments of the present disclosure, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "back", "left", "right", "vertical", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the purpose of facilitating the description of the embodiments of the present disclosure and simplifying the description, and therefore cannot be understood as indicating or implying that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the embodiments of the present disclosure.

[0037] In the embodiments of the present disclosure, unless otherwise explicitly specified and limited, a first feature "on" or "under" a second feature can be that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature "above", "over" and "on" the second feature can be that the first feature is directly above or obliquely above the second feature, or only indicates that the horizontal height of the first feature is higher than that of the second feature. The first feature "below", "under" and "under" the second feature can be that the first feature is directly below or obliquely below the second feature, or only indicates that the horizontal height of the first feature is less than that of the second feature.

[0038] In addition, the terms "first", "second", "third", etc. are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, the features defined with "first", "second" can explicitly or implicitly include at least one of the features. For example, the first support frame can also be referred to as the second support frame, and the second support frame can also be referred to as the first support frame. In the description of the present disclosure, the meaning of "a plurality of" is at least two, such as two, three, etc., unless otherwise explicitly specified and limited.

[0039] In the embodiments of the present disclosure, unless specifically defined and limited otherwise, the terms "connected", "connected", and the like should be interpreted broadly, for example, can be fixedly connected, can be detachably connected, or integrated; can be flexibly connected, or rigidly connected in at least one direction; can be mechanically connected, or electrically connected; can be directly connected, or indirectly connected through an intermediate medium, or directly connected while the intermediate medium exists, or the internal communication of two elements or the interaction relationship between two elements. Unless otherwise specifically defined, the terms "installation", "arrangement", "fixation" and the like can be broadly interpreted as connection. For those skilled in the art, the specific meanings of the above terms in the embodiments of the present disclosure can be understood according to specific circumstances.

[0040] Reference Figure 1 , Figure 1 The expansion diagram of the heart valve stent 10 in the embodiments of the present disclosure is shown. The present disclosure relates to the technical field of medical devices.

[0041] In combination Figures 2 to 5 , the embodiments of the present disclosure provide a heart valve stent 10, which is a radially contractible and expandable annular frame. Exemplarily, the annular frame is a mesh structure, facilitating the radial contraction and expansion of the heart valve stent 10. The heart valve stent 10 comprises an inflow end 1, an outflow end 2 and a connecting assembly 4. Exemplarily, the lower half of the heart valve stent 10 along the axial direction is the inflow end 1, and the upper half is the outflow end 2.

[0042] The inflow end 1 comprises a plurality of first support frames 11, which are sequentially and circumferentially arranged. The outflow end 2 comprises a plurality of second support frames 21, which are sequentially arranged circumferentially. Each first support frame 11 is connected to a corresponding second support frame 21. The connecting assembly 4 comprises a plurality of first connecting rods 41 and a plurality of second connecting rods 42. Exemplarily, two adjacent first support frames 11 are connected along the circumference by the first connecting rod 41, and the first support frames 11 and the first connecting rods 41 are sequentially connected to form the inflow end 1. Two adjacent second support frames 21 are connected along the circumference, and a plurality of second support frames 21 are sequentially connected along the circumference to form the outflow end 2. Each first support frame 11 is connected to a corresponding second support frame 21 arranged along the axial direction by the second connecting rod 42.

[0043] Each first support frame 11 comprises two spaced top connecting ends 1121, the two top connecting ends 1121 are spaced along the circumferential direction; each second support frame 21 comprises two spaced bottom connecting ends 2111, the two bottom connecting ends 2111 are spaced along the circumferential direction; one top connecting end 1121 and one bottom connecting end 2111 correspondingly arranged along the axial direction are connected to form a connecting point 3, another top connecting end 1121 and another bottom connecting end 2111 correspondingly arranged along the axial direction are connected to form another connecting point 3, the two connecting points 3 are spaced along the circumferential direction, and two ends of one second connecting rod 42 are connected to the two connecting points 3 respectively.

[0044] Each first support frame 11 comprises two waist connecting ends 111, and two ends of each first connecting rod 41 are connected to the waist connecting ends 111 of adjacent first support frames 11.

[0045] With reference to Figures 1 to 5 , the heart valve stent 10 provided by the embodiment of the present disclosure, the second connecting rod 42 is used for connecting the inflow end 1 and the outflow end 2, and the first connecting rod 41 is used for connecting the first support frames 11 along the circumferential direction. The first connecting rod 41 and the second connecting rod 42 jointly act to reduce the number of the first support frames 11 and the second support frames 21 forming the annular frame, and when the heart valve stent 10 is contracted, the heart valve stent 10 can be compressed to a smaller size. With the horizontal rod (the first connecting rod 41 and the second connecting rod 42) as a reference standard, the annular structure formed by the first connecting rod 41 is more obvious, and the annular structure formed by the second connecting rod 42 is also more obvious. After being implanted in the body, the position of the first connecting rod 41 is convenient to observe and position, and the accuracy of anchoring with the patient's own valve is improved. When the heart valve stent 10 is expanded, the first connecting rod 41 and the second connecting rod 42 obviously enhance the radial support force, realize the balance of the radial support force and the compressibility, and ensure the structural stability of the heart valve stent 10 after contraction and expansion.

[0046] With reference to Figure 2 , for example, the first connecting rod 41 has a certain length along the circumferential direction, and after the heart valve stent 10 is contracted, a plurality of first connecting rods 41 form an annular structure with a plurality of gaps along the circumferential direction, and the annular structure presents obvious black development under the image. Therefore, the plurality of first connecting rods 41 can serve as a release marker to confirm that the heart valve stent 10 is located at the position of the patient's own valve before being released.

[0047] With reference to Figure 3 , for example, the second connecting rod 42 has a certain length along the circumferential direction and a certain width along the axial direction. The size of the second connecting rod 42 can affect the radial support force and the size after compression, the width affects the radial support force in an exponential manner, and the length can affect the size after compression and the stability and balance of the heart valve stent 10. The second connecting rod 42 is a horizontal rod, and the connection between the second connecting rod 42 and the connecting point 3 is in the form of a circular arc.

[0048] It can be understood that the length and width of the second connecting rod 42 can be designed according to different specifications of the heart valve stent 10. The second connecting rod 42 ensures the stability of the annular frame when the heart valve stent 10 switches between compression and expansion, so as not to lose stability.

[0049] Reference Figure 4 With Figure 5 In some embodiments, the heart valve stent 10 has a radially deformed expanded state and a contracted state; in the expanded state, the radial dimension of the outflow end 2 is larger than that of the inflow end 1.

[0050] In this way, the heart valve stent 10 in the expanded state is slightly trumpet-shaped, which can better control the expected size of the artificial valve 20 and further ensure the hemodynamics, so that the blood flow passes through the heart valve stent 10 more smoothly.

[0051] For example, after the balloon expands the heart valve stent 10, the radial dimension of the annular formed by the plurality of circumferentially connected second support frames 21 is slightly larger than that of the annular formed by the plurality of circumferentially connected first support frames 11 and the first connecting rod 41, and the trumpet mouth of the slightly trumpet-shaped is the upper half of the heart valve stent 10.

[0052] It can be understood that the balloon expands the heart valve stent 10 into a cylinder with a large outflow and a small inflow. Since the first connecting rod 41 is located at the annulus itself, the inflow end 1 reaches the expected radial dimension, which can prevent affecting the left ventricular outflow tract, reduce the probability of conduction block, and ensure the safety of the left ventricle of the heart.

[0053] In other embodiments, in the expanded state, the radial dimension of the outflow end 2 can be less than or equal to the radial dimension of the inflow end 1.

[0054] Reference Figure 1 , Figure 2 and Figure 5 In some embodiments, the first support frame 11 further comprises two waist support rods 112, a bottom connecting rod 113 and two bottom support rods 114. Each waist support rod 112 is connected to a bottom support rod 114 to form a waist connecting end 111, and the two waist support rods 112 form two spaced top connecting ends 1121, and the two ends of the bottom connecting rod 113 are connected to the bottom ends of the two bottom support rods 114. In this way, the bottom connecting rod 113 is in the shape of a horizontal bar and has a certain length in the circumferential direction. The bottom connecting rod 113 in the contracted heart valve stent 10 is closer to a circle, greatly reducing the risk of scratching the blood vessel.

[0055] Reference Figure 2For example, the top end of the waist support rod 112 is the top connection end 1121.

[0056] For example, the bottom end of the waist support rod 112 is axially connected to the top end of the bottom support rod 114, and the bottom connecting rod 113 is circumferentially connected to the bottom ends of the two bottom support rods 114.

[0057] For example, in the expanded state, both the waist support rod 112 and the bottom support rod 114 are arc-shaped along the axial direction. In the contracted state, both the waist support rod 112 and the bottom support rod 114 are straight along the axial direction.

[0058] refer to Figure 1 and Figure 5 In some embodiments, the axial dimension of the waist support rod 112 is larger than that of the bottom support rod 114. This configuration results in the first support frame 11 being a quadrilateral grid with a larger axial dimension, reducing the material of the first support frame 11 while keeping the axial dimension of the heart valve stent 10 constant. Under the same compression deformation conditions, the first support frame 11 can be compressed to a smaller size.

[0059] For example, in the expanded state, the first support frame 11 is peach-shaped.

[0060] In other embodiments, the axial dimension of the waist support rod 112 is equal to the axial dimension of the bottom support rod 114. Alternatively, the axial dimension of the waist support rod 112 is smaller than the axial dimension of the bottom support rod 114.

[0061] refer to Figures 1 to 5 In some embodiments, the second support frame 21 includes a hexagonal frame, which includes two upper inclined rods 213, two lower inclined rods 211, two vertical rods 212 and a top connecting rod 214. The two ends of the top connecting rod 214 are respectively connected to the top ends of the two upper inclined rods 213. The bottom end of each upper inclined rod 213 and the top end of each lower inclined rod 211 are respectively connected to the two ends of a vertical rod 212. The two lower inclined rods 211 form two spaced bottom connecting ends 2111.

[0062] With this configuration, the hexagonal frames are connected in sequence, making the outflow end 2 sparser than the inflow end 1. The radial support force of the outflow end 2 is less than that of the inflow end 1. When the balloon is inflated, the radial dimension of the outflow end 2 is greater than that of the inflow end 1, which better reduces the impact of the artificial valve 20 on the left and right coronary arteries. At the same time, it provides sufficient space for coronary artery protection and coronary stent release during the operation.

[0063] refer to Figure 3 For example, the bottom end of the lower inclined rod 211 is the bottom connection end 2111.

[0064] In one embodiment, the two ends of the top connecting rod 214 are connected to the tops of the two upper inclined rods 213, the bottom ends of the two upper inclined rods 213 are respectively connected to the tops of the two vertical rods 212, the bottom ends of the two vertical rods 212 are respectively connected to the tops of the two lower inclined rods 211, the bottom ends of the two lower inclined rods 211 are respectively connected to the tops of the two waist support rods 112 and form two spaced connection points 3, the bottom ends of the two waist support rods 112 are respectively connected to the tops of the two bottom support rods 114, the bottom ends of the two bottom support rods 114 are connected to the two ends of the bottom connecting rod 113, and the two ends of the second connecting rod 42 are connected to the two spaced connection points 3.

[0065] This invention employs a first connecting rod 41 that precisely connects the waist connecting ends 111 of adjacent first support frames 11 in a circumferential, fitted manner. The connecting rods are evenly distributed, ensuring connection strength and stability, thereby constructing a continuous beam-type support structure. This structure differs from the simple point connection method of commercially available supports, enabling the even distribution of force and avoiding stress concentration problems caused by discrete force application.

[0066] This invention employs an asymmetrical eccentric layout. The eccentricity was optimized through multiple experiments to determine the final numerical range. When the second connecting rod 42 connects to the connection point 3, a special rod connection method is used to ensure precise connection angle and position. This connection method effectively counteracts the non-uniform deformation generated during radial expansion. The displacement of commercially available brackets before and after compression is 6.63514 mm, while the displacement of the bracket of this invention after compression is only 3.95562 mm, significantly reducing displacement deformation.

[0067] This invention optimizes the width-to-length ratio of the second connecting rod 42. During the design process, the optimal range for the width and length of the second connecting rod 42 was determined. This unique design of the optimized width-to-length ratio allows the second connecting rod 42 to work synergistically with the first connecting rod 41 and the first support frame 11 when subjected to radial and axial forces, enhancing the stability of the entire support system. The elongation of commercially available brackets before and after compression is 0.368622985, while the elongation of the bracket of this invention before and after compression is 0.22161826.

[0068] The first support frame waist connection end of the present invention adopts a unique design. The waist connection end 111 of the first support frame 11 adopts a unique gradient cross-section design, and its cross-section gradually changes from the part connected to the first connecting rod 41 to the main body of the first support frame 11. This design can optimize the material distribution while ensuring the connection strength, further improve the mechanical properties of the first support frame 11, and enable it to better transmit and disperse stress in the entire support structure.

[0069] In some embodiments, the ratio of the distance between the first connecting rod 41 and the bottom connecting rod 113 to the distance between the top connecting rod 214 and the bottom connecting rod 113 ranges from 5% to 40%.

[0070] With this configuration, the first connecting rod 41 provides support at the lower middle position of the heart valve stent 10 for anchoring with the patient's own valve. Without increasing the density of the heart valve stent 10, it significantly enhances the radial support force, improves the safety and accuracy of anchoring, and reduces the incidence of conduction block.

[0071] For example, the ratio of the distance between the first connecting rod 41 and the bottom connecting rod 113 to the distance between the top connecting rod 214 and the bottom connecting rod 113 can be 10%, 20%, or 30%. The doctor will determine the anchoring position based on the patient's individual condition, such as the degree of calcification and the cardiac anatomy, so that the expanded structure of the heart valve stent 10 is better suited to the case.

[0072] refer to Figure 1 and Figure 5 In some embodiments, the longitudinal bars 212 of two adjacent second support frames 21 are arranged at circumferential intervals of 120° to form a fixing hole 22. This arrangement allows the fixing hole 22 to facilitate the connection and fixation of the artificial valve 20 to the heart valve stent 10.

[0073] For example, the fixing hole 22 is formed by connecting the top and bottom ends of the two longitudinal rods 212 of the two adjacent second support frames 21 respectively.

[0074] For example, the fixing hole 22 is a rectangular through hole that connects the inner and outer sides of the heart valve stent. In other embodiments, the fixing hole 22 may also be a circular through hole or a through hole of other shapes.

[0075] refer to Figure 1 and Figure 5 In some embodiments, the top connecting rod 214 and the second connecting rod 42 are axially eccentrically asymmetrically designed. This arrangement prevents the heart valve stent 10 from tilting when changing from an expanded to a contracted state.

[0076] For example, the centerline of the top connecting rod 214 along the axial direction does not coincide with the centerline of the second connecting rod 42 along the axial direction.

[0077] refer to Figure 1 and Figure 5In some embodiments, two adjacent second support frames 21 are eccentrically and asymmetrically connected along the axial direction. The eccentric and asymmetrical design of the fixing hole 22, the top connecting rod 214, and the second connecting rod 42 causes the heart valve stent 10 to be unbalanced. Therefore, the eccentric and asymmetrical design of the second support frame 21 integrates the aforementioned imbalance to maintain the overall balance and ensure the stability of the heart valve stent 10 after compression and expansion.

[0078] For example, two adjacent second support frames 21 share a single longitudinal bar 212, the upper end of which is asymmetrically connected to two upper diagonal bars 213. For example, the lower end of the longitudinal bar 212 is asymmetrically connected to two lower diagonal bars 211.

[0079] In one embodiment, the upper end of the longitudinal bar 212 is connected near the upper inclined bar 213 of the second support frame 21 on the right, and the lower end of the longitudinal bar 212 is connected near the lower inclined bar 211 of the second support frame 21 on the left, thus mitigating the imbalance in the connection. In other embodiments, the upper end of the longitudinal bar 212 is connected near the upper inclined bar 213 of the second support frame 21 on the left, and the lower end of the longitudinal bar 212 is connected near the lower inclined bar 211 of the second support frame 21 on the right.

[0080] refer to Figure 6 This disclosure provides an artificial heart valve 100, which includes the aforementioned heart valve stent 10, artificial valve 20, and polymer skirt 30. The artificial valve 20 is located within and connected to the heart valve stent 10 within its annular frame. A portion of the polymer skirt 30 is located within the annular frame of the heart valve stent 10, and another portion of the polymer skirt 30 is located inside and outside the annular frame of the heart valve stent 10. The polymer skirt 30 is connected to the artificial valve 20 and the heart valve stent 10.

[0081] The artificial heart valve 100 of this disclosure comprises an artificial valve 20 and a polymer skirt 30 connected to each other via a heart valve stent 10 and implanted in the body, anchored to the original valve. The heart valve stent 10 can be compressed to a smaller size during contraction, reducing the risk of blood vessel damage, increasing radial support and balance, ensuring the stability of the heart valve stent 10 after expansion, and thus ensuring smooth blood flow through the artificial heart valve 100.

[0082] For example, a suture (not shown) passes through the fixation hole 22 to connect the artificial valve 20 to the polymer skirt 30 and suture the artificial valve 20 to the polymer skirt 30 to the heart valve stent 10.

[0083] For example, the artificial valve 20 can be a bioprosthetic valve or a polymeric valve. Bioprosthetic valves include bovine pericardium, porcine pericardium, or other biological pericardium.

[0084] 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.

[0085] 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 by the embodiments of this disclosure can be achieved, and no limitations are imposed herein.

[0086] The embodiments disclosed above merely illustrate several implementation methods of the present invention, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A heart valve stent, being an annular frame which is radially contractible and expandable, characterized in that, The heart valve stent (10) comprises: an inflow end (1) comprising a plurality of first support frames (11) arranged circumferentially and sequentially, each of the first support frames (11) comprising two waist connecting ends (111), two spaced top connecting ends (1121), two bottom ends and a bottom end connecting rod (113), the two ends of the bottom end connecting rod (113) being connected to the two bottom ends respectively, the bottom end connecting rod (113) being in the shape of a horizontal bar and having a certain length in the circumferential direction; an outflow end (2) comprising a plurality of second support frames (21) arranged circumferentially and sequentially, each of the second support frames (21) comprising two spaced bottom connecting ends (2111) and having two longitudinal rods (212) and a top end connecting rod (214), each of the first support frames (11) being connected to a second support frame (21) correspondingly, the two bottom connecting ends (2111) being connected to the two top connecting ends (1121) correspondingly and forming two spaced connecting points (3), the longitudinal rods (212) of two adjacent second support frames (21) forming a fixing hole (22) in the circumferential direction every 120°; and a connecting assembly (4) comprising a plurality of first connecting rods (41) and a plurality of second connecting rods (42), the two ends of each of the first connecting rods (41) being connected to the waist connecting ends (111) of two adjacent first support frames (11) respectively, the two ends of each of the second connecting rods (42) being connected to two connecting points (3) respectively, the top end connecting rod (214) and the second connecting rod (42) being designed to be eccentrically asymmetric in the axial direction, and two adjacent second support frames (21) being connected to be eccentrically asymmetric in the axial direction.

2. The heart valve stent of claim 1, wherein, The heart valve stent (10) has an expanded state and a contracted state in the radial direction. In the expanded state, the radial dimension of the outflow end (2) is greater than the radial dimension of the inflow end (1).

3. The heart valve stent of claim 1, wherein, The first support frame (11) further comprises two waist support rods (112), a bottom end connecting rod (113) and two bottom end support rods (114), each of the waist support rods (112) being connected to one of the bottom end support rods (114) and forming the waist connecting end (111), the two waist support rods (112) forming the two spaced top connecting ends (1121), and the two ends of the bottom end connecting rod (113) being connected to the bottom ends of the two bottom end support rods (114) respectively.

4. The heart valve stent of claim 3, wherein, The axial dimension of the waist support rod (112) is greater than the axial dimension of the bottom end support rod (114).

5. The heart valve stent of claim 3, wherein, The second support frame (21) comprises a hexagonal frame, the hexagonal frame comprises two upper inclined rods (213), two lower inclined rods (211), two vertical rods (212) and a top connecting rod (214), two ends of the top connecting rod (214) are connected to top ends of the two upper inclined rods (213) respectively, bottom ends of each of the upper inclined rods (213) and top ends of each of the lower inclined rods (211) are connected to two ends of one of the vertical rods (212) respectively, and the two lower inclined rods (211) form two spaced bottom connecting ends (2111).

6. The heart valve stent of claim 5, wherein, The ratio of the distance between the first connecting rod (41) and the bottom connecting rod (113) to the distance between the top connecting rod (214) and the bottom connecting rod (113) is in the range of 5% to 40%.

7. A prosthetic heart valve, characterized in that, The heart valve stent (10), the artificial valve (20) and the polymer skirt (30) are connected to each other, the artificial valve (20) is located in the annular frame of the heart valve stent (10), and a part of the polymer skirt (30) is located in the annular frame of the heart valve stent (10).

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