Heart valve stent and artificial heart valve

Abstract

The invention relates to a heart valve stent and a prosthetic heart valve. The heart valve stent is an annular frame capable of contracting and expanding in the radial direction, the heart valve stent comprises an inflow end, an outflow end and a connecting assembly, the inflow end comprises a plurality of first supporting frames which are sequentially arranged at intervals in the circumferential direction, and each first supporting frame comprises two waist connecting ends and two spaced top connecting ends; the outflow end comprises a plurality of second supporting frames which are sequentially arranged in the circumferential direction, each second supporting frame comprises two spaced bottom connecting ends, each first supporting frame is correspondingly connected to one second supporting frame, and the two bottom connecting ends are correspondingly connected with the two top connecting ends respectively to form two spaced connecting points; the connecting assembly comprises a plurality of first connecting rods and a plurality of second connecting rods, and the two ends of each first connecting rod are connected to the waist connecting ends of the adjacent first supporting frames correspondingly. The two ends of each second connecting rod are connected to the two connecting points respectively. The radial supporting force is enhanced, and balance between the radial supporting force and compressibility is achieved.

Description

Technical Field

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

[0002] Heart valves grow between the atria and ventricles, and between the ventricles and large arteries, acting as one-way valves to assist the unidirectional movement of blood flow. If a heart valve malfunctions, it will affect the movement of blood flow, resulting in abnormal heart function and ultimately heart failure. Therefore, when the autologous heart valve is damaged, abnormal, or non-functional, a heart valve replacement surgery must be performed.

[0003] In traditional heart valve replacement, the surgical operation is an open and highly invasive procedure. The surgical trauma is large and requires extracorporeal circulation. The surgical risk is very high, and adverse reactions such as massive bleeding, infection, and arrhythmia are prone to occur during the operation, resulting in the patient even needing several months to recover.

[0004] In recent years, researchers have been working on achieving interventional catheter artificial heart valve replacement without opening the chest or placing the patient on extracorporeal circulation, aiming to minimize trauma and enable the biological valve to be deployed through the patient's own valve, thus avoiding resection of the diseased valve of the patient.

[0005] A balloon-expandable valve usually consists of a heart valve stent and an artificial valve. Before implantation, the balloon-expandable valve needs to be compressed and delivered through a specific delivery device via an access sheath to the location of the own valve and then expanded, and then supported on the patient's own valve. Therefore, the balloon-expandable valve should be able to pass through the smallest possible access blood vessel, and at the same time, the valve stent needs sufficient supporting force after expansion to minimize the patient's trauma and ensure safety. However, most of the existing heart valve stents are direct connections of rods, making it difficult to achieve a balance between radial supporting force and compressibility, and it is also difficult to anchor to the own valve. Summary of the Invention

[0006] Based on this, it is necessary to provide a heart valve stent and an artificial heart valve that can achieve a balance between radial supporting force and compressibility and facilitate anchoring to the own valve.

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

[0008] When the heart valve stent provided by the present application expands radially, the first connecting rod connects the first support frame, and the second connecting rod connects the inflow end and the outflow end. The first connecting rod and the second connecting rod act together to reduce the number of the first support frame and the second support frame forming the annular frame, and can be compressed to a smaller size. The annular structure formed by the compressed first connecting rod can be anchored to the patient's own valve. When the heart valve stent expands, the first connecting rod and the second connecting rod significantly enhance the radial supporting force, realize the balance between the radial supporting force and the compressibility, and ensure the structural stability of the heart valve stent after contraction and expansion.

[0009] In some embodiments, the heart valve stent has an expanded state and a contracted state that are deformed radially. In the expanded state, the radial dimension of the outflow end is greater than the radial dimension of the inflow end.

[0010] With such a setting, the heart valve stent in the expanded state is in a micro trumpet shape, which can better control the expected size of the artificial valve, further ensure hemodynamics, and make the blood flow more smoothly through the heart valve stent.

[0011] In some embodiments, each first support frame further includes two waist support rods, a bottom end connecting rod and two bottom end support rods. Each waist support rod is correspondingly connected to a bottom end support rod to form a waist connection end. The two waist support rods form two spaced-apart top connection ends. Two ends of the bottom end connecting rod are respectively connected to the bottom ends of the two bottom end support rods.

[0012] With such a setting, the bottom end connecting rod is in the shape of a cross bar and has a certain length in the circumferential direction. The bottom end connecting rod in the contracted heart valve stent is closer to a circle, greatly reducing the risk of scratching blood vessels.

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

[0014] With such a setting, the first support frame is a quadrilateral grid and has a relatively large size along the axial direction, reducing the material of the first support frame while keeping the axial size of the heart valve stent unchanged. Under the same condition of crimping and deformation, the first support frame can be compressed to a smaller size.

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

[0016] With such a setting, the hexagonal frames are sequentially connected such that the outflow end is sparser relative to the inflow end. The radial support force at the outflow end is less than that at the inflow end. When the balloon is inflated, the radial size of the outflow end is larger than that of the inflow end, better reducing the impact of the artificial valve on the left and right coronary arteries, and at the same time providing sufficient space for coronary protection during the operation and releasing a coronary stent.

[0017] In some of these 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] With such a setting, 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. Without increasing the density of the heart valve stent, the radial support force is significantly enhanced, improving the safety and accuracy of anchoring and reducing the incidence of conduction block.

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

[0020] With such a setting, the fixing hole facilitates the connection and fixation of the artificial valve to the heart valve stent.

[0021] In some of these embodiments, the top connecting rod and the second connecting rod are eccentric and asymmetrically designed along the axial direction.

[0022] With such a setting, it prevents the heart valve stent from skewing when changing from the expanded state to the contracted state.

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

[0024] The eccentric and asymmetric designs of the fixing hole, the top connecting rod, and the second connecting rod make the heart valve stent unbalanced. Therefore, the eccentric and asymmetric design of the second support frame synthesizes the foregoing imbalance to maintain the overall balance, ensuring the stability of the heart valve stent after compression and expansion.

[0025] The present application provides an artificial heart valve, which includes the above-mentioned heart valve stent, artificial valve and polymer skirt. The artificial valve is located within the annular frame of the heart valve stent and is connected to the heart valve stent. A part of the polymer skirt is located within the annular frame of the heart valve stent, and another part of the polymer skirt is located outside the annular frame of the heart valve stent. The polymer skirt is connected to the artificial valve and the heart valve stent.

[0026] For the artificial heart valve provided by the present application, the artificial valve and the polymer skirt are connected through the heart valve stent and implanted into the body to anchor with the native valve. The heart valve stent can be compressed to a smaller size during systole, reducing the risk of scratching blood vessels, increasing the radial support force and balance, ensuring the stability of the heart valve stent after expansion, and thus ensuring the smooth flow of blood through the artificial heart valve. Description of the Drawings

[0027] Figure 1 is an expanded schematic view of the heart valve stent in the embodiment of the present disclosure;

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

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

[0030] Figure 4 is a schematic view of the heart valve stent in the embodiment of the present disclosure in a contracted state;

[0031] Figure 5 is a schematic view of the heart valve stent in the embodiment of the present disclosure in an expanded state;

[0032] Figure 6 is a schematic view of the structure of the artificial heart valve in the embodiment of the present disclosure.

[0033] Reference Signs:

[0034] 100, artificial heart valve; 10, heart valve stent; 1, inflow end; 11, first support frame; 111, waist connection end; 112, waist support rod; 1121, top connection end; 113, bottom connecting rod; 114, bottom support rod; 2, outflow end; 21, second support frame; 211, lower inclined rod; 2111, bottom connection end; 212, longitudinal rod; 213, upper inclined rod; 214, top connecting rod; 22, fixing hole; 3, connection point; 4, connection assembly; 41, first connecting rod; 42, second connecting rod; 20, artificial valve; 30, polymer skirt. Detailed Description

[0035] To make the above objects, features, and advantages of the embodiments of the present disclosure more apparent and understandable, the following provides a detailed description of the specific embodiments of the present disclosure in conjunction with the accompanying drawings. A lot of specific details are set forth in the following description to facilitate a full understanding of the embodiments of the present disclosure. However, the embodiments of the present disclosure can be implemented in many other ways different from those described herein. Those skilled in the art can make similar improvements without departing from the spirit of the embodiments of the present disclosure. Therefore, the embodiments of the present disclosure are not limited by the specific embodiments disclosed below.

[0036] In the description of the embodiments of the present disclosure, it should be understood that 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. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings. These are only for the convenience of describing the embodiments of the present disclosure 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. Therefore, they should not be construed as limitations on the embodiments of the present disclosure.

[0037] In the embodiments of the present disclosure, unless otherwise clearly specified and limited, the first feature being "on" or "under" the second feature may mean 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 mean 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 mean 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.

[0038] In addition, the terms "first", "second", "third", etc. are used only 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, features defined with "first" and "second" may explicitly or implicitly include at least one such feature. Exemplarily, the first support frame may also be referred to as the second support frame, and the second support frame may also be referred to as the first support frame. In the description of the present invention, the meaning of "a plurality" is at least two, such as two, three, etc., unless otherwise specifically defined.

[0039] In the embodiments of the present disclosure, unless otherwise clearly specified and limited, terms such as "connected" and "coupled" shall be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or an integral one; it may be a flexible connection or a rigid connection in 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 there may be an intermediate medium while being directly connected, and it may also be the internal communication of two components or the interaction relationship between two components, unless otherwise clearly limited. Terms such as "installed", "set", and "fixed" may be understood in a broad sense as a connection. For those of ordinary skill in the art, the specific meanings of the above terms in the embodiments of the present disclosure may be understood according to specific circumstances.

[0040] Reference Figure 1 , Figure 1 shows the deployment view of the heart valve stent 10 in the embodiments of the present disclosure. The present disclosure relates to the technical field of medical devices.

[0041] Combined with 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 includes an inflow end 1, an outflow end 2, and a connection assembly 4. Exemplarily, the lower half of the heart valve stent 10 in the axial direction is the inflow end 1, and the upper half is the outflow end 2.

[0042] The inflow end 1 includes a plurality of first support frames 11, and the plurality of first support frames 11 are circumferentially arranged at intervals in sequence. The outflow end 2 includes a plurality of second support frames 21, and the plurality of second support frames 21 are circumferentially arranged in sequence. Each first support frame 11 is correspondingly connected to a second support frame 21. The connection assembly 4 includes a plurality of first connecting rods 41 and a plurality of second connecting rods 42. Exemplarily, two adjacent first support frames 11 are connected circumferentially by the first connecting rod 41, and the first support frames 11 and the first connecting rods 41 are sequentially connected to enclose the inflow end 1. Two adjacent second support frames 21 are connected circumferentially, and the plurality of second support frames 21 are sequentially connected circumferentially to form the outflow end 2. Each first support frame 11 is connected to the second support frame 21 arranged correspondingly in the axial direction through the second connecting rod 42.

[0043] Each first support frame 11 includes two spaced-apart top connection ends 1121, and the two top connection ends 1121 are circumferentially spaced; each second support frame 21 includes two spaced-apart bottom connection ends 2111, and the two bottom connection ends 2111 are circumferentially spaced; an axially corresponding top connection end 1121 and a bottom connection end 2111 are connected to form a connection point 3, and the other axially corresponding top connection end 1121 and the other bottom connection end 2111 are connected to form another connection point 3. The two connection points 3 are circumferentially spaced, and two ends of a second connecting rod 42 are respectively connected to the two connection points 3.

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

[0045] Reference Figures 1 to 5 , for the heart valve stent 10 provided by the embodiment of the present disclosure, the second connecting rod 42 is used to connect the inflow end 1 and the outflow end 2, and the first connecting rod 41 is used to connect the first support frames 11 circumferentially. The first connecting rod 41 and the second connecting rod 42 act together to reduce the number of the first support frames 11 and the second support frames 21 forming the annular frame. After the heart valve stent 10 is contracted, it can be compressed to a smaller size. Taking the cross bars (the first connecting rod 41 and the second connecting rod 42) as the reference standard, the annular structure formed by the first connecting rod 41 is relatively obvious, and the ring structure formed by the second connecting rod 42 is also relatively obvious. After being implanted into the body, it is convenient to observe and locate the position of the first connecting rod 41 and improve the accuracy of anchoring with the patient's own valve. When the heart valve stent 10 expands, the first connecting rod 41 and the second connecting rod 42 significantly enhance the radial supporting force, achieve the balance between the radial supporting force and the compressibility, and ensure the structural stability of the heart valve stent 10 after contraction and expansion.

[0046] Reference Figure 2 , exemplarily, the first connecting rod 41 has a certain length circumferentially. After the heart valve stent 10 is contracted, a plurality of first connecting rods 41 form an annular structure with a plurality of gaps circumferentially, presenting obvious black imaging under imaging. Therefore, the plurality of first connecting rods 41 can be used as release markers to confirm the position of the heart valve stent 10 in its own valve before release.

[0047] Reference Figure 3 , exemplarily, the second connecting rod 42 has a certain length circumferentially and a certain width axially. The dimensional change of the second connecting rod 42 can affect the radial supporting force and the size after compression. The width affects the radial supporting force exponentially, 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 cross bar, and the connection between the second connecting rod 42 and the connection point 3 is arc-shaped.

[0048] It is understandable that both 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 And Figure 5 , in some embodiments, the heart valve stent 10 has a radially deformable expanded state and a contracted state; in the expanded state, the radial dimension of the outflow end 2 is greater than the radial dimension of the inflow end 1.

[0050] With such a setting, the heart valve stent 10 in the expanded state is in a micro-trumpet shape, which can better control the expected size of the artificial valve 20, further ensure hemodynamics, and make the blood flow more smoothly through the heart valve stent 10.

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

[0052] It is understandable 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 its own valve annulus, 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 includes two waist support rods 112, a bottom connecting rod 113 and two bottom support rods 114. Each waist support rod 112 is correspondingly connected to a bottom support rod 114 to form a waist connection end 111, and the two waist support rods 112 form two spaced top connection ends 1121. The two ends of the bottom connecting rod 113 are respectively connected to the bottoms of the two bottom support rods 114. With such a setting, the bottom connecting rod 113 is in the shape of a crossbar 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 blood vessels.

[0055] Reference Figure 2, Exemplarily, the top end of the lumbar support rod 112 is the top connection end 1121.

[0056] Exemplarily, the bottom end of the lumbar 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] Exemplarily, in the expanded state, both the lumbar support rod 112 and the bottom support rod 114 are arc-shaped along the axial direction. In the contracted state, the lumbar support rod 112 and the bottom support rod 114 are linear along the axial direction.

[0058] Reference Figure 1 and Figure 5 , In some of these embodiments, the axial dimension of the lumbar support rod 112 is greater than the axial dimension of the bottom support rod 114. With this setting, the first support frame 11 is a quadrilateral grid and has a relatively large axial dimension, reducing the material of the first support frame 11 without changing the axial dimension of the heart valve stent 10. Under the same crimping and deformation conditions, the first support frame 11 can be compressed to a smaller size.

[0059] Exemplarily, in the expanded state, the first support frame 11 is in a peach shape.

[0060] In other embodiments, the axial dimension of the lumbar support rod 112 is equal to the axial dimension of the bottom support rod 114. Or the axial dimension of the lumbar support rod 112 is less than the axial dimension of the bottom support rod 114.

[0061] Reference Figures 1 to 5 , In some of these embodiments, the second support frame 21 includes a hexagonal frame. The hexagonal frame includes two upper diagonal rods 213, two lower diagonal rods 211, two longitudinal 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 diagonal rods 213. The bottom end of each upper diagonal rod 213 and the top end of each lower diagonal rod 211 are respectively connected to the two ends of a longitudinal rod 212. The two lower diagonal rods 211 form two spaced bottom connection ends 2111.

[0062] With this setting, the hexagonal frame is sequentially connected such that the outflow end 2 is 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 larger than that of the inflow end 1, better reducing the impact of the artificial valve 20 on the left and right coronary arteries, and at the same time providing sufficient space for coronary protection during the operation and releasing the coronary stent.

[0063] Reference Figure 3 , Exemplarily, the bottom end of the lower diagonal rod 211 is the bottom connection end 2111.

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

[0065] The present invention uses the first connecting rod 41 to accurately connect the waist connection ends 111 of adjacent first support frames 11 in a circumferentially fitting manner. The connecting rods are evenly distributed to ensure the connection strength and stability, thereby constructing a continuous beam type support structure. This structure is different from the simple point connection method of commercially available brackets, and can evenly disperse the force, avoiding the stress concentration problem caused by discrete force.

[0066] The present invention adopts an asymmetric eccentric layout, and the eccentricity is optimized through multiple experiments, and finally the numerical range of the present invention is determined. When the second connecting rod 42 is connected to the connection point 3, a special rod connection method is adopted to ensure the accurate connection angle and position. This connection method can effectively offset the non-uniform deformation generated during radial expansion. The displacement of the commercially available bracket before and after crimping is 6.63514 mm, while the displacement of the bracket of the present invention after crimping is only 3.95562 mm, and the displacement deformation is significantly reduced.

[0067] The present invention deeply optimizes the width-to-length ratio of the second connecting rod 42. During the design process, the best range of the width and length of the second connecting rod 42 is determined. The unique design of the optimized width-to-length ratio enables the second connecting rod 42 to cooperate with the first connecting rod 41 and the first support frame 11 when bearing radial and axial forces, enhancing the stability of the entire support system. The elongation rate of the commercially available bracket before and after crimping is 0.368622985, while the elongation rate of the bracket of the present invention before and after crimping is 0.22161826.

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

[0069] In some of these 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 such a setting, the first connecting rod 41 provides support at the middle and lower positions of the heart valve stent 10 for anchoring to the patient's own valve. Without increasing the density of the heart valve stent 10, the radial support force is significantly enhanced, the safety and accuracy of anchoring are improved, and the incidence of conduction block is reduced.

[0071] Exemplarily, 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 according to the patient's individual conditions such as the degree of calcification and the cardiac anatomical structure, so that the structure of the heart valve stent 10 after expansion better suits the case.

[0072] Reference Figure 1 and Figure 5 In some of these embodiments, along the circumferential direction, every 120°, the longitudinal rods 212 of two adjacent second support frames 21 enclose to form a fixing hole 22. With such a setting, the fixing hole 22 facilitates the connection and fixation of the artificial valve 20 to the heart valve stent 10.

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

[0074] Exemplarily, the shape of the fixing hole 22 is a rectangular through-hole that can communicate the inside and outside of the heart valve stent. In other embodiments, the fixing hole 22 can also be a circular through-hole or a through-hole of other shapes.

[0075] Reference Figure 1 and Figure 5 In some of these embodiments, the top connecting rod 214 and the second connecting rod 42 are eccentric and asymmetrically designed along the axial direction. With such a setting, it is prevented that the heart valve stent 10 skews when changing from the expanded state to the contracted state.

[0076] Exemplarily, the axial center line of the top connecting rod 214 does not coincide with the axial center line of the second connecting rod 42.

[0077] Reference Figure 1 and Figure 5, in some embodiments, two adjacent second support frames 21 are eccentrically and asymmetrically connected along the axial direction. The eccentric and asymmetric design of the fixing holes 22, the top connecting rod 214 and the second connecting rod 42 makes the heart valve stent 10 unbalanced. Therefore, the eccentric and asymmetric design of the second support frame 21 synthesizes the aforementioned unbalance to maintain the overall balance and ensure the stability of the heart valve stent 10 after compression and expansion.

[0078] Exemplarily, two adjacent second support frames 21 share a longitudinal rod 212, and the upper end of the longitudinal rod 212 is asymmetrically connected to two upper inclined rods 213. Exemplarily, the lower end of the longitudinal rod 212 is asymmetrically connected to two lower inclined rods 211.

[0079] In one embodiment, the connection at the upper end of the longitudinal rod 212 is close to the upper inclined rod 213 of the second support frame 21 on the right side, and the connection at the lower end of the longitudinal rod 212 is close to the lower inclined rod 211 of the second support frame 21 on the left side, synthesizing the imbalance of the connection. In other embodiments, the connection at the upper end of the longitudinal rod 212 is close to the upper inclined rod 213 of the second support frame 21 on the left side, and the connection at the lower end of the longitudinal rod 212 is close to the lower inclined rod 211 of the second support frame 21 on the right side.

[0080] Reference Figure 6 , the present disclosure provides an artificial heart valve 100. The artificial heart valve 100 includes the above-mentioned heart valve stent 10, an artificial valve 20 and a polymer skirt 30. The artificial valve 20 is located within the annular frame of the heart valve stent 10 and is connected to the heart valve stent 10. A part of the polymer skirt 30 is located within the annular frame of the heart valve stent 10, and another part 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] For the artificial heart valve 100 according to the embodiment of the present disclosure, the artificial valve 20 and the polymer skirt 30 are connected through the heart valve stent 10 and implanted into the body to anchor to the self-valve. The heart valve stent 10 can be compressed to a smaller size during contraction, reducing the risk of scratching blood vessels, increasing the radial support force and balance, and ensuring the stability of the heart valve stent 10 after expansion, thereby ensuring the smooth blood flow of the artificial heart valve 100.

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

[0083] Exemplarily, the artificial valve 20 can be a biological valve or a polymer valve. The biological valve includes bovine pericardium, porcine pericardium or other biological pericardia.

[0084] The technical features of the embodiments disclosed above can be combined arbitrarily. For the sake of concise 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 described in this specification.

[0085] In the embodiments disclosed above, unless otherwise clearly specified and limited, the execution order of each step is not restricted. For example, they can be executed in parallel or in different orders successively. 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 embodiments of the present disclosure can be achieved. This is not restricted herein.

[0086] The embodiments disclosed above only represent several implementation manners of the present invention, and the description is relatively specific and detailed. However, it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the present invention patent shall be subject to the appended claims.

Claims

1. A heart valve stent, which is a radially contractible and expandable annular frame, is characterized in that Comprising: An inflow end (1), including a plurality of first support frames (11), the plurality of first support frames (11) being circumferentially arranged at intervals in sequence, each first support frame (11) including two waist connection ends (111) and two spaced top connection ends (1121); An outflow end (2), including a plurality of second support frames (21), the plurality of second support frames (21) being circumferentially arranged in sequence, each second support frame (21) including two spaced bottom connection ends (2111), each first support frame (11) being correspondingly connected to a second support frame (21), the two bottom connection ends (2111) being respectively correspondingly connected to the two top connection ends (1121) and forming two spaced connection points (3); and A connection assembly (4), including a plurality of first connecting rods (41) and a plurality of second connecting rods (42), two ends of each first connecting rod (41) being respectively connected to the waist connection ends (111) of adjacent first support frames (11); two ends of each second connecting rod (42) being respectively connected to the two connection points (3).

2. The heart valve stent according to claim 1, wherein, The heart valve stent (10) has a dilated state and a contracted state that are deformed radially; In the dilated 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 according to claim 1, characterized in that, The first support frame (11) further includes two waist support rods (112), a bottom end connecting rod (113), and two bottom end support rods (114), each waist support rod (112) being correspondingly connected to a bottom end support rod (114) and forming the waist connection end (111), the two waist support rods (112) forming two spaced top connection ends (1121), and two ends of the bottom end connecting rod (113) being respectively connected to the bottom ends of the two bottom end support rods (114).

4. The heart valve stent according to claim 3, characterized in that, 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 according to claim 3, characterized in that, The second support frame (21) includes a hexagonal frame, the hexagonal frame including two upper inclined rods (213), two lower inclined rods (211), two longitudinal rods (212), and a top end connecting rod (214), two ends of the top end connecting rod (214) being 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) being respectively connected to two ends of a longitudinal rod (212), and the two lower inclined rods (211) forming two spaced bottom connection ends (2111).

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

7. The heart valve stent according to claim 5, wherein, At intervals of 120° circumferentially, the longitudinal rods (212) of adjacent second support frames (21) enclose a fixing hole (22).

8. The heart valve stent according to claim 7, characterized in that, The top end connecting rod (214) and the second connecting rod (42) are eccentric and asymmetrically designed axially.

9. The heart valve stent according to claim 8, wherein, Two adjacent second support frames (21) are eccentrically and asymmetrically connected along the axial direction.

10. An artificial heart valve, characterized in that, Comprising a heart valve stent (10), an artificial valve (20) and a polymer skirt (30) according to any one of claims 1 to 9, wherein the artificial valve (20) is located within the annular frame of the heart valve stent (10) and connected to the heart valve stent (10), a part of the polymer skirt (30) is located within the annular frame of the heart valve stent (10), another part of the polymer skirt (30) is located outside the annular frame of the heart valve stent (10), and the polymer skirt (30) is connected to the artificial valve (20) and the heart valve stent (10).

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