Valve stent and aorta heart valve prosthesis

Abstract

The utility model provides a valve stent and an artificial heart valve of an aorta, the valve stent can be radially compressed or radially expanded, and a net-shaped annular frame structure of the valve stent comprises a first connecting edge, a second connecting edge, a third connecting edge, a fourth connecting edge, a first common edge and a second common edge which are bent in an S shape; when an original aorta artificial heart valve fails, only the first connecting edge, the second connecting edge, the third connecting edge, the fourth connecting edge, the first common edge and the second common edge which are bent in an S shape need to be straightened under the action of external force, so that the valve stent can perform secondary radial expansion, and the original aorta artificial heart valve does not need to be taken out; the aorta artificial heart valve of the same model or size can be directly implanted into the diseased part of the heart valve of the patient again, so that the situation that the aorta artificial heart valve of a small size can only be implanted into the diseased part of the heart valve of the patient again due to the fact that the valve support cannot achieve secondary radial expansion is avoided.

Description

Technical Field

[0001] The utility model belongs to the technical field of heart valves, and in particular relates to a valve stent and an aortic artificial heart valve. Background Art

[0002] Heart valve diseases are mostly treated with transvascular technology that uses a catheter delivery assembly to deliver and implant an artificial heart valve. The artificial valve is installed in a curled state at the distal end of the catheter delivery assembly. The catheter delivery assembly advances through the patient's blood vessels to the implantation site, and the artificial valve at the distal end of the catheter delivery assembly is propped open by balloon inflation. This treatment method can effectively improve treatment efficiency and relieve patients' pain.

[0003] Currently, for patients with severe aortic heart valve calcification, balloon-expandable artificial heart valves are generally used to implant artificial heart valves. Since the valve stent of the artificial heart valve is usually unable to undergo secondary radial expansion when implanted in the patient's heart valve diseased area, when the artificial heart valve fails or is damaged, a smaller artificial heart valve can only be implanted into the patient's heart valve diseased area again through a pre-expansion balloon, which makes it difficult for the patient's heart function to maintain normal, thus reducing the treatment effect and quality of life. Utility Model Content

[0004] Based on the above-mentioned problems existing in the prior art, the purpose of the embodiments of the utility model is to provide a valve stent to solve the technical problem that the valve stent of the artificial heart valve in the prior art cannot be radially expanded a second time, and when the artificial heart valve fails or is damaged, an artificial heart valve of a smaller model or size can only be implanted into the patient's heart valve diseased site again, making it difficult for the patient to maintain normal heart function.

[0005] To achieve the above-mentioned purpose, the technical solution adopted by the utility model is: to provide an aortic artificial heart valve, comprising:

[0006] A first wavy annular border;

[0007] a second wave-shaped annular frame, parallel to and spaced from the first wave-shaped annular frame; and

[0008] A mesh annular frame, located between the first wave-shaped annular frame and the second wave-shaped annular frame, and connecting the first wave-shaped annular frame and the second wave-shaped annular frame;

[0009] Wherein, along the axial direction of the mesh annular frame, the mesh annular frame includes a first annular frame formed by splicing a row of first diamond grids and a second annular frame formed by splicing a row of second diamond grids, a first node is formed between two adjacent first diamond grids, a second node is formed between two adjacent second diamond grids, a third node is formed at the connection between the upper corner of each first diamond grid and the first wavy annular frame, and a fourth node is formed at the connection between the lower corner of each second diamond grid and the second wavy annular frame, so that the valve stent can be radially compressed or radially expanded; each first diamond grid is formed by enclosing a first connecting edge, a second connecting edge, a first common edge and a second common edge, and each second diamond grid is formed by enclosing a third connecting edge, a fourth connecting edge, a first common edge and a second common edge, and the first connecting edge, the second connecting edge, the third connecting edge, the fourth connecting edge, the first common edge and the second common edge are respectively arranged to be S-shaped, so that the radially expanded valve stent can be radially expanded twice.

[0010] Furthermore, when the valve stent is in a radially compressed state, each of the first connecting edges with an S-shaped curve is fitted or anastomosed with the corresponding second connecting edge with an S-shaped curve, each of the third connecting edges with an S-shaped curve is fitted or anastomosed with the corresponding fourth connecting edge with an S-shaped curve, and each of the first common edges with an S-shaped curve is fitted or anastomosed with the corresponding second common edge with an S-shaped curve, so that the valve stent can be enclosed to form a hollow columnar structure.

[0011] Furthermore, the first wavy annular frame is formed by a serrated cobalt-chromium alloy wire, and a first U-shaped connection portion is formed at the connection between the first wavy annular frame and each of the third nodes, and a plurality of first inverted U-shaped connection portions are formed at one end of the first wavy annular frame away from the third node.

[0012] Furthermore, the second wavy annular frame is formed by a serrated cobalt-chromium alloy wire, and a second U-shaped connection portion is formed at the connection between the second wavy annular frame and each of the fourth nodes, and a plurality of second inverted U-shaped connection portions are formed at one end of the second wavy annular frame away from the fourth node.

[0013] Furthermore, the first wavy annular frame is connected to the upper part of the mesh annular frame through a plurality of first connecting rods, and the second wavy annular frame is connected to the lower part of the mesh ring through a plurality of second connecting rods, so that the first wavy annular frame, the second wavy annular frame and the mesh annular frame constitute a mesh annular frame structure.

[0014] Furthermore, a plurality of the first connecting rods are vertically arranged, and the plurality of the first connecting rods are evenly spaced along the circumference of the mesh annular frame.

[0015] Furthermore, a plurality of the second connecting rods are vertically arranged, and the plurality of the second connecting rods are evenly spaced along the circumference of the mesh annular frame.

[0016] Furthermore, the valve support is made of a plastically deformable alloy material with anti-fatigue performance, and the plastically deformable alloy material is a cobalt-chromium alloy or a nickel-titanium alloy.

[0017] Furthermore, a groove is concavely provided on the outer surface of the valve stent, and a drug-carrying coating is covered on the concave surface of the groove.

[0018] Another object of the embodiments of the utility model is to provide an aortic artificial heart valve including the valve stent provided by any of the above embodiments, so as to solve the technical problem that the valve stent of the artificial heart valve in the prior art cannot be radially expanded a second time, and when the artificial heart valve fails or is damaged, an artificial heart valve of a smaller model or size can only be implanted again into the patient's heart valve diseased site, making it difficult for the patient to maintain normal heart function.

[0019] To achieve the above-mentioned purpose, the technical solution adopted by the present invention is: to provide an aortic artificial heart valve, including the valve stent provided by any of the above-mentioned embodiments.

[0020] Compared with the prior art, the above one or more technical solutions in the embodiments of the present invention have at least one of the following beneficial effects:

[0021] The aortic artificial heart valve in the embodiment of the utility model has a valve stent that can be radially compressed or radially expanded, and the mesh annular frame structure of the valve stent includes a first connecting edge, a second connecting edge, a third connecting edge, a fourth connecting edge, a first common edge and a second common edge that are curved in an S shape. When the original aortic artificial heart valve fails, it is only necessary to straighten the first connecting edge, the second connecting edge, the third connecting edge, the fourth connecting edge, the first common edge and the second common edge that are curved in an S shape under the action of external force, so that the valve stent can be radially expanded a second time. There is no need to remove the original aortic artificial heart valve, and the aortic artificial heart valve of the same model or size can be directly implanted into the patient's heart valve diseased site again, thereby eliminating the need to implant a smaller aortic artificial heart valve into the patient's heart valve diseased site again due to the inability of the valve stent to achieve secondary radial expansion. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0023] Figure 1 A schematic diagram of the three-dimensional structure of the aortic artificial heart valve provided by an embodiment of the utility model in a radially expanded state;

[0024] Figure 2 Another three-dimensional structural schematic diagram of the aortic artificial heart valve provided by an embodiment of the utility model in a radially expanded state;

[0025] Figure 3 Another three-dimensional structural schematic diagram of the aortic artificial heart valve provided by an embodiment of the utility model in a radially expanded state;

[0026] Figure 4 A schematic cross-sectional view of the aortic artificial heart valve provided by an embodiment of the utility model in a radially expanded state;

[0027] Figure 5 An exploded view of the valve support and skirt structure provided by an embodiment of the utility model;

[0028] Figure 6 A schematic diagram of the three-dimensional structure of the aortic artificial heart valve provided by an embodiment of the utility model in a radially compressed state;

[0029] Figure 7 A schematic diagram of the three-dimensional structure of the valve stent provided by the embodiment of the utility model in a radially compressed state;

[0030] Figure 8 A schematic diagram of the three-dimensional structure of the valve stent provided by the embodiment of the utility model in a radially expanded state;

[0031] Fig. 9 A schematic diagram of the structure of the skirt structure provided by an embodiment of the utility model;

[0032] Fig.10 A schematic diagram of a partially enlarged structure of the valve stent provided in an embodiment of the utility model when it is in a radially expanded state.

[0033] Among them, the reference numerals in the figure are:

[0034] 1-artificial valve; 11-valve leaflet;

[0035] 2-valve support; 21-inflow section; 211-first wave-shaped annular frame; 212-first U-shaped connecting part; 213-first inverted U-shaped connecting part; 22-flow-through section; 221-net-shaped annular frame; 222-first diamond grid; 2221-first connecting edge; 2222-second connecting edge; 223-second diamond grid; 2231-third connecting edge; 2232-fourth connecting edge; 224-first common edge; 225-second common edge; 23-outflow section; 231-second wave-shaped annular frame; 232-second U-shaped connecting part; 233-second inverted U-shaped connecting part; 24-first node; 25-second node; 26-third node; 27-fourth node; 28-first connecting rod; 29-second connecting rod;

[0036] 3-skirt structure; 31-inner skirt; 32-outer skirt; 33-arc-shaped bending surface; 34-annular protrusion; 35-gap; 36-outer protrusion; 37-first connecting ear; 38-second connecting ear; 4-groove. DETAILED DESCRIPTION

[0037] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0038] It should be noted that when an element is referred to as being "connected to" or "set on" another element, it can be directly on the other element or indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or indirectly connected to the other element. In addition, the terms "first", "second", "third" and "fourth" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first", "second", "third" and "fourth" can explicitly or implicitly include one or more of the features. In the description of the utility model, the meaning of "multiple" is two or more, unless otherwise clearly specified and specifically defined. In the description of the utility model, it should be noted that, unless otherwise clearly specified and defined, the terms "installed", "connected" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For those skilled in the art, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances.

[0039] Reference throughout the specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present application. Thus, when the phrases "in one embodiment," "in some embodiments," or "in some of these embodiments" appear in various places throughout the specification, not all references are to the same embodiment. Furthermore, in one or more embodiments, the particular features, structures, or characteristics may be combined in any suitable manner.

[0040] Please also read Figures 1 to 10 The aortic artificial heart valve provided by the embodiment of the utility model is now described. Figure 1 , Figure 2 and Figure 3 The aortic artificial heart valve provided by the embodiment of the utility model includes an artificial valve 1, a valve support 2 and a skirt structure 3. The artificial valve 1 includes a plurality of flexible leaflets 11 made of shape memory material. The material of the leaflets 11 is one or more of biological tissues, polymer materials, and tissue engineering materials that have been treated with a solution. For example, the material of the leaflets 11 is preferably pericardial material. The pericardial material mainly includes porcine pericardium and bovine pericardium. Porcine pericardium is a dense tissue that wraps the pig heart. Bovine pericardium is a dense tissue that wraps the bovine heart. The content of collagen in porcine pericardial tissue and bovine pericardial tissue is high, and they are very dense and tight. The artificial valve 1 made of them has better tolerance to the pressure of the cardiac cycle and is less bent under bending stress. Therefore, the artificial valve 1 made of pericardial material has better tolerance to the pressure of the cardiac cycle, thereby improving the medical effect and durability of the artificial valve 1. On the one hand, the valve stent 2 is used to support and fix the artificial valve 1. The artificial valve 1 relies on the supporting force of the valve stent 2 to maintain a circular state. On the other hand, the valve stent 2 is used to support the patient's heart valve, implant and fix the artificial valve 1 at the patient's native heart valve lesion, so that the artificial valve 1 can replace the patient's native heart valve and maintain normal heart function. The valve stent 2 is made of a plastically deformable alloy material with fatigue resistance, so that the valve stent 2 can be radially compressed or radially expanded. When the valve stent 2 is in radial compression, it can be implanted into the heart through the patient's aortic blood vessel. When the valve stent 2 is in radial expansion, it can provide radial support force to support the patient's heart valve.

[0041] Please refer to further Figure 1 , Figure 7 and Figure 8When the valve stent 2 is in a radially expanded state, a mesh annular frame structure can be formed, the mesh annular frame structure includes an inflow section 21, an outflow section 23 and a flow-through section 22 connecting the inflow section 21 and the outflow section 23, and the artificial valve 1 is arranged in the inflow section 21 and / or the flow-through section 22. The skirt structure 3 is used to fit the irregular pathological tissue structure of the calcified part of the patient, and the skirt structure 3 is arranged on the valve stent 2 near the outflow section 23. The skirt structure 3 is made of a polymer material with shape memory, so that the skirt structure 3 can closely fit the pathological tissue structure of the calcified part of the patient by relying on its own shape memory performance, and even when encountering an irregular or uneven calcified tissue structure surface, the skirt structure 3 can still fit well or well with the calcified heart valve. In addition, since the skirt structure 3 can fully fit with the irregular or uneven calcified tissue structure surface, it not only effectively increases the contact area between the skirt structure 3 and the diseased tissue structure in the calcified area of ​​the patient, but also makes the skirt structure 3 and the diseased tissue structure in the calcified area of ​​the patient more closely contacted, which can play a good role in preventing the aortic artificial heart valve from falling off and slipping.

[0042] Compared with the prior art, the artificial aortic heart valve provided in the embodiment of the utility model has a skirt structure 3 arranged on the valve stent 2 that carries the artificial valve 1. Since the skirt structure 3 is made of a polymer material with shape memory, the skirt structure 3 can closely fit the pathological tissue structure of the calcified part of the patient by relying on its own shape memory performance, and can effectively improve the fit between the artificial aortic heart valve and the irregularly calcified or uneven tissue structure surface of the patient's heart valve, thereby ensuring that the artificial aortic heart valve is completely consistent with the pathological tissue structure of the patient and effectively preventing paravalvular leakage. Furthermore, since the skirt structure 3 can closely fit the irregular pathological tissue structure of the calcified part of the patient by relying on its own shape memory property, the skirt structure 3 can closely fit the pathological tissue structure of the calcified part of the patient, thereby enabling the skirt structure 3 to fully fit the irregular or uneven calcified tissue structure surface of the patient, which not only effectively increases the contact area between the skirt structure 3 and the pathological tissue structure of the calcified part of the patient, but also can enhance the tightness of the contact between the skirt structure 3 and the pathological tissue structure of the calcified part of the patient, thereby facilitating a good anti-detachment and anti-slip effect on the artificial aortic heart valve.

[0043] In some of the embodiments, the plastically deformable alloy material is a cobalt-chromium alloy or a nickel-titanium alloy, which, on the one hand, enables the valve stent 2 to have a greater supporting force, so that the aortic artificial heart valve will not lose its roundness during implantation or long-term exercise, thereby improving the durability of the valve stent 2; on the other hand, it enables the valve stent 2 to have a good plastic deformation ability, which can ensure that the aortic artificial heart valve can be radially compressed to be small enough to be easily non-invasively inserted into the heart through the patient's blood vessels, and can also ensure that the aortic artificial heart valve can be radially expanded and quickly expanded by a pre-expansion balloon. In other words, the valve stent 2 is made of a plastically deformable alloy material such as a cobalt-chromium alloy or a nickel-titanium alloy, so that the valve stent 2 has both strong supporting strength and better plastic deformation ability, which not only enables the valve stent 2 to be radially compressed or radially expanded, but also enables the radially expanded valve stent 2 to have a strong supporting ability. It should be noted that, in some other embodiments, the valve stent 2 can also be made of shape memory alloy. Before the valve stent 2 is implanted into the patient's heart, the valve stent 2 is in a contracted state. After the valve stent 2 is implanted into the patient's heart, it can expand and be in an expanded state.

[0044] In some of the embodiments, the polymer material with shape memory is a polyester fiber membrane. The skirt structure 3 is made of the polyester fiber membrane. The skirt structure 3 only needs to be molded on the valve stent 2, so that the skirt structure 3 can rely on its own shape memory performance to fit tightly with the pathological tissue structure of the patient's calcified area, which can effectively improve the fit between the aortic artificial heart valve and the irregular or uneven calcified tissue structure surface of the patient's heart valve, thereby ensuring that the aortic artificial heart valve is completely consistent with the patient's pathological tissue structure and effectively preventing paravalvular leakage, ensuring that the skirt structure 3 fits the growth of the calcified heart valve, effectively increasing the contact area between the skirt structure 3 and the pathological tissue structure of the patient's calcified area, and enhancing the tightness of the contact between the skirt structure 3 and the pathological tissue structure of the patient's calcified area.

[0045] Please refer to Figure 2 , Figure 3 and Fig. 9In some embodiments, the skirt structure 3 includes an inner skirt 31 extending to the inner side of the outflow section 23 and an outer skirt 32 extending to the outer side of the outflow section 23. The connection between the inner skirt 31 and the outer skirt 32 forms an arc-shaped bending surface 33, so that the outer skirt 32 forms an annular protrusion 34 protruding toward the pathological tissue structure of the calcified part of the patient. The annular protrusion 34 abuts against the pathological tissue structure of the calcified part of the patient, further enhancing the tightness of the contact between the skirt structure 3 and the pathological tissue structure of the calcified part of the patient, and also improving the fit or anastomosis between the skirt structure 3 and the pathological tissue structure of the calcified part of the patient, thereby effectively enhancing the effect of preventing paravalvular leakage and preventing detachment and slipping. In addition, an anti-slip step is formed on the outer skirt 32 near the annular protrusion 34. During the pre-expansion and implantation of the artificial aortic heart valve, the pre-expansion balloon can contact the calcified aortic valve through the anti-slip step, thereby increasing the friction between the artificial aortic heart valve and the calcified aortic valve, and effectively preventing the artificial aortic heart valve from shifting or slipping from the calcified aortic valve during the implantation process, thereby overcoming the defect that the artificial aortic heart valve is prone to shifting or slipping, making it difficult for the artificial aortic heart valve to adapt to the pre-expansion treatment of the calcified part of the aortic valve and the stenosis part of the lesion.

[0046] Please refer to Figure 4 In some embodiments, a gap 35 is provided between a portion of the outer skirt 32 adjacent to the arcuate bending surface 33 and an outer side surface of the outflow section 23, so that the portion of the outer skirt 32 adjacent to the arcuate bending surface 33 can be locally concavely deformed toward the outer side surface of the outflow section 23, thereby enabling the portion of the outer skirt 32 adjacent to the arcuate bending surface 33 to adapt well to the irregular or uneven calcified tissue structure surface at the patient's heart valve, which is beneficial to improving the fit between the skirt structure 3 and the pathological tissue structure at the calcified site of the patient, and enhancing the tightness of the contact between the skirt structure 3 and the pathological tissue structure at the calcified site of the patient.

[0047] Please refer to Figure 5 , Figure 6 and Figure 7In some embodiments, the valve stent 2 includes a first wavy annular frame 211, a second wavy annular frame 231 parallel to and spaced from the first wavy annular frame 211, and a mesh annular frame 221 connecting the first wavy annular frame 211 and the second wavy annular frame 231; along the axial direction of the mesh annular frame 221, the mesh annular frame 221 includes a first annular frame formed by splicing a row of first diamond grids 222 and a second annular frame formed by splicing a row of second diamond grids 223, a first node 24 is formed between two adjacent first diamond grids 222, a second node 25 is formed between two adjacent second diamond grids 223, a third node 26 is formed at the connection between the upper corner of each first diamond grid 222 and the first wavy annular frame 211, a fourth node 27 is formed at the connection between the lower corner of each second diamond grid 223 and the second wavy annular frame 231, and the flow-through segment 22 is located between the third node 26 and the fourth node 27. In this embodiment, the first wave-shaped annular frame 211 is connected to the upper part of the mesh annular frame 221 through a plurality of first connecting rods 28, and the second wave-shaped annular frame 231 is connected to the lower part of the mesh annular frame 221 through a plurality of second connecting rods 29, so that the first wave-shaped annular frame 211, the second wave-shaped annular frame 231 and the mesh annular frame 221 constitute a mesh annular frame structure (the valve stent 2 is in an expanded state), so that the valve stent 2 has a greater supporting force after being expanded and expanded by the pre-expansion balloon. It should be noted that the plurality of first connecting rods 28 are arranged in a vertical state, and the plurality of first connecting rods 28 are arranged at equal intervals along the circumference of the mesh annular frame 221, which, on the one hand, facilitates radial compression and radial expansion of the valve stent 2, and on the other hand, can enhance the supporting force of the valve stent 2. The plurality of second connecting rods 29 are arranged in a vertical state, and the plurality of second connecting rods 29 are arranged at equal intervals along the circumference of the mesh annular frame 221, which, on the one hand, facilitates radial compression and radial expansion of the valve stent 2, and on the other hand, can enhance the supporting force of the valve stent 2.

[0048] Please refer to Figure 5 , Figure 7 and Fig.10In some embodiments, each first diamond grid 222 is formed by a first connecting edge 2221, a second connecting edge 2222, a first common edge 224 and a second common edge 225, and each second diamond grid 223 is formed by a third connecting edge 2231, a fourth connecting edge 2232, a first common edge 224 and a second common edge 225, and the first connecting edge 2221, the second connecting edge 2222, the third connecting edge 2231, the fourth connecting edge 2232, the first common edge 224 and the second common edge 225 are respectively arranged to be S-shaped. In this embodiment, since the valve stent 2 is made of a plastically deformable alloy material such as cobalt-chromium alloy or nickel-titanium alloy, the first connecting edge 2221, the second connecting edge 2222, the first common edge 224 and the second common edge 225 of the first diamond grid 222 are respectively arranged to be S-shaped bends, and the third connecting edge 2231, the fourth connecting edge 2232, the first common edge 224 and the second common edge 225 of the second diamond grid 223 are respectively arranged to be S-shaped bends, so that the valve stent 2 that has been radially expanded by the pre-expansion balloon can undergo secondary radial expansion. In this way, when the original artificial aortic heart valve fails or needs to be replaced with a new one, it is only necessary to straighten the S-shaped first connecting edge 2221, the second connecting edge 2222, the third connecting edge 2231, the fourth connecting edge 2232, the first common edge 224 and the second common edge 225 under the action of external force, so that the valve stent 2 can smoothly undergo a secondary radial expansion. There is no need to remove the original artificial aortic heart valve, and the artificial aortic heart valve of the same model or size can be directly re-implanted into the patient's heart valve diseased area. Therefore, because the valve stent 2 cannot be radially expanded a second time, a smaller artificial aortic heart valve can be re-implanted into the patient's heart valve diseased area through a pre-expansion balloon, which makes it difficult for the patient's heart function to maintain normal and reduces the treatment effect and quality of life.

[0049] Please refer to Figure 1 , Figure 2 and Figure 3 In some embodiments, when the valve stent 2 is in a radially compressed state, each first connecting edge 2221 with an S-shaped curve is tightly fitted or anastomosed with the corresponding second connecting edge 2222 with an S-shaped curve, each third connecting edge 2231 with an S-shaped curve is tightly fitted or anastomosed with the corresponding fourth connecting edge 2232 with an S-shaped curve, and each first common edge 224 with an S-shaped curve is tightly fitted or anastomosed with the corresponding second common edge 225 with an S-shaped curve, so that when the valve stent 2 is in an initial state of radial compression, the valve stent 2 can be enclosed to form a hollow cylindrical structure with a smaller diameter and size, thereby facilitating the non-invasive implantation of the aortic artificial heart valve into the patient's heart aorta through the patient's aortic blood vessel.

[0050] Please refer to Figure 7 , Figure 8 and Fig.10 In some embodiments, a groove 4 is concavely provided on the outer surface of the valve stent 2, and the groove 4 is loaded with drugs for reducing inflammation or preventing thrombosis, which can reduce the occurrence of inflammation on the one hand, and reduce the amount of medication after surgery on the other hand, and promote the integration of the aortic artificial heart valve and human tissue. Specifically, the concave surface of the groove 4 is covered with a drug-loaded coating to prevent the aortic artificial heart valve from falling off before being transplanted to the patient's heart valve site, resulting in the failure of the drug to treat the patient's target. In this embodiment, the drug is coated on the concave surface of the groove 4 in the form of a coating to prevent the drug from falling off due to the squeezing and friction of the blood vessel wall during the process of non-invasively implanting the aortic artificial heart valve into the patient's heart aorta through the patient's aortic blood vessel. It should be noted that the drug-loaded coating is a drug-containing coating formed by coating the concave surface of the groove 4 with drugs that reduce the occurrence of inflammation and promote the integration of the aortic artificial heart valve and human tissue.

[0051] Please refer to Figure 4 , Figure 5 and Fig. 9 In some embodiments, one end of the skirt structure 3 away from the valve support 2 protrudes radially outwards to form an outer protrusion 36 for abutting and fitting with the calcified irregular part of the patient's heart valve. In this embodiment, the outer protrusion 36 protruding from the skirt structure 3 abuts and fits with the calcified irregular part of the patient's heart valve, further enhancing the tightness of the contact between the skirt structure 3 and the pathological tissue structure of the calcified part of the patient, and also improving the fit between the skirt structure 3 and the pathological tissue structure of the calcified part of the patient, thereby effectively enhancing the effect of preventing paravalvular leakage and preventing detachment and slipping.

[0052] Please refer to Figure 1 , Figure 2 and Fig. 9 In some embodiments, a plurality of first connecting ears 37 are provided on the side of the inner skirt 31 away from the arc-shaped bending surface 33, and the first connecting ears 37 are connected to the outer sides of the first connecting edge 2221 and the second connecting edge 2222 of the first diamond grid 222, and the shape and size of the first connecting ears 37 are adapted to the shape and size of the vertex angle of the first diamond grid 222.

[0053] Please refer to Figure 1 , Figure 2 and Fig. 9In some embodiments, a plurality of second connecting ears 38 are provided on the side of the outer skirt 32 away from the arc-shaped bending surface 33, and the second connecting ears 38 are connected to the outer sides of the third connecting edge 2231 and the fourth connecting edge 2232 of the second diamond grid 223, and the shape and size of the second connecting ears 38 are adapted to the shape and size of the bottom angle of the second diamond grid 223.

[0054] Please refer to Figure 4 , Figure 5 and Figure 6 In some embodiments, when the valve stent 2 is in a radially compressed state, the inner skirt 31 is coupled to the inner side of the valve stent 2 in a folded state, and the outer skirt 32 is coupled to the outer side of the valve stent 2 in a folded state. When the valve stent 2 is in a radially expanded state, the inner skirt 31 is attached to the inner side of the valve stent 2, the upper part of the inner skirt 31 is attached to the outer side of the valve stent 2, and the lower part of the inner skirt 31 forms an annular protrusion 34 or an outer protrusion 36 protruding toward the pathological tissue structure of the calcified part of the patient.

[0055] Please refer to Figure 1 , Figure 7 and Figure 8 In some embodiments, the artificial valve 1 is located inside the valve stent 2 corresponding to the inflow section 21 and / or the flow-through section 22, so that the blood flowing through the artificial valve 1 can achieve good unidirectional flow. In addition, the length and radial support force of the flow-through section 22 can ensure that the aortic artificial heart valve is tightly combined with the patient's heart aorta in the circumferential direction, and can ensure the stability of the aortic artificial heart valve when implanted in the patient's heart.

[0056] Please refer to Figure 3 , Figure 5 and Figure 8 In some embodiments, the first wave-shaped annular frame 211 is formed by a sawtooth cobalt-chromium alloy wire, and the connection between the first wave-shaped annular frame 211 and each third node 26 is respectively formed with a first U-shaped connection portion 212, and the end of the first wave-shaped annular frame 211 away from the third node 26 is formed with a plurality of first inverted U-shaped connection portions 213, which is conducive to making the valve stent 2 more compressed. The second wave-shaped annular frame 231 is formed by a sawtooth cobalt-chromium alloy wire, and the connection between the second wave-shaped annular frame 231 and each fourth node 27 is respectively formed with a second U-shaped connection portion 232, and the end of the second wave-shaped annular frame 231 away from the fourth node 27 is formed with a plurality of second inverted U-shaped connection portions 233, which is conducive to making the valve stent 2 more compressed.

[0057] Please refer to Figure 2 , Figure 8 and Fig.10In some embodiments, a first node 24 is formed between two adjacent first diamond grids 222, a second node 25 is formed between two adjacent second diamond grids 223, a third node 26 is formed at the connection between the upper corner of each first diamond grid 222 and the first waveform annular frame 211, a fourth node 27 is formed at the connection between the lower corner of each second diamond grid 223 and the second waveform annular frame 231, the flow-through section 22 is located between the third node 26 and the fourth node 27, the inflow section 21 is located between the first inverted U-shaped connection portion 213 and the third node 26, the outflow section 23 is located between the second inverted U-shaped connection portion 233 and the fourth node 27, the outer skirt 32 is arranged on the outer side of the outflow section 23, and the inner skirt 31 covers the inner side of the flow-through section 22 and the outflow section 23. The side of the outer skirt 32 close to the flow-through section 22 is combined with the connection between the flow-through section 22 and the outflow section 23 by a suturing process or a thermoplastic molding process, and the side of the inner skirt 31 away from the outflow section 23 is combined with the flow-through section 22 by a suturing process or a thermoplastic molding process, so that the lower part of the inner skirt 31 forms an annular protrusion 34 or an outer protrusion 36 protruding toward the pathological tissue structure of the calcified part of the patient. It should be noted that when the skirt structure 3 adopts a thin polyester fiber membrane, the outer skirt 32 is formed by folding outward along the radial direction of the valve stent 2 on the side of the inner skirt 31 close to the outflow section 23, so that the lower part of the inner skirt 31 can form an annular protrusion 34 or an outer protrusion 36 protruding toward the pathological tissue structure of the calcified part of the patient through a heat setting process.

[0058] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A valve stent, characterized in that: include: A first wavy annular border; A second wave-shaped annular frame is parallel to and spaced apart from the first wave-shaped annular frame; as well as A mesh annular frame, located between the first wave-shaped annular frame and the second wave-shaped annular frame, and connecting the first wave-shaped annular frame and the second wave-shaped annular frame; Wherein, along the axial direction of the mesh annular frame, the mesh annular frame includes a first annular frame formed by splicing a row of first diamond grids and a second annular frame formed by splicing a row of second diamond grids, a first node is formed between two adjacent first diamond grids, a second node is formed between two adjacent second diamond grids, a third node is formed at the connection between the upper corner of each first diamond grid and the first wavy annular frame, and a fourth node is formed at the connection between the lower corner of each second diamond grid and the second wavy annular frame, so that the valve stent can be radially compressed or radially expanded; each first diamond grid is formed by enclosing a first connecting edge, a second connecting edge, a first common edge and a second common edge, and each second diamond grid is formed by enclosing a third connecting edge, a fourth connecting edge, a first common edge and a second common edge, and the first connecting edge, the second connecting edge, the third connecting edge, the fourth connecting edge, the first common edge and the second common edge are respectively arranged to be S-shaped, so that the radially expanded valve stent can be radially expanded twice.

2. The valve stent according to claim 1, characterized in that: When the valve stent is in a radially compressed state, each of the first connecting edges with an S-shaped curve is fitted or anastomosed with the corresponding second connecting edges with an S-shaped curve, each of the third connecting edges with an S-shaped curve is fitted or anastomosed with the corresponding fourth connecting edges with an S-shaped curve, and each of the first common edges with an S-shaped curve is fitted or anastomosed with the corresponding second common edges with an S-shaped curve, so that the valve stent can be enclosed to form a hollow columnar structure.

3. The valve stent according to claim 1, characterized in that: The first wavy annular frame is formed by a serrated cobalt-chromium alloy wire, and a first U-shaped connecting portion is formed at the connection between the first wavy annular frame and each of the third nodes, and a plurality of first inverted U-shaped connecting portions are formed at one end of the first wavy annular frame away from the third node.

4. The valve stent according to claim 1, characterized in that: The second wavy annular frame is formed by a serrated cobalt-chromium alloy wire, and a second U-shaped connection portion is formed at the connection between the second wavy annular frame and each of the fourth nodes, and a plurality of second inverted U-shaped connection portions are formed at one end of the second wavy annular frame away from the fourth node.

5. The valve stent according to claim 1, characterized in that: The first wavy annular frame is connected to the upper part of the mesh annular frame through a plurality of first connecting rods, and the second wavy annular frame is connected to the lower part of the mesh ring through a plurality of second connecting rods, so that the first wavy annular frame, the second wavy annular frame and the mesh annular frame constitute a mesh annular frame structure.

6. The valve stent according to claim 5, characterized in that: A plurality of the first connecting rods are vertically arranged, and the plurality of the first connecting rods are evenly spaced along the circumference of the mesh annular frame.

7. The valve stent according to claim 5, characterized in that: A plurality of the second connecting rods are vertically arranged, and the plurality of the second connecting rods are evenly spaced along the circumference of the mesh annular frame.

8. The valve stent according to claim 1, characterized in that: The valve support is made of a plastically deformable alloy material with anti-fatigue performance, and the plastically deformable alloy material is a cobalt-chromium alloy or a nickel-titanium alloy.

9. The valve stent according to any one of claims 1 to 8, characterized in that: A groove is concavely arranged on the outer surface of the valve support, and a drug-carrying coating is covered on the concave surface of the groove.

10. An aortic artificial heart valve, characterized in that: Comprising the valve stent according to any one of claims 1 to 9.

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