A heart valve prosthesis

Abstract

The present application provides a heart valve prosthesis, which has a first end and a second end opposite in a first direction; the heart valve prosthesis comprises a first support body, a second support body and an artificial valve leaflet; the first support body has a first edge and a second edge opposite in a second direction, which is perpendicular to the first direction; the second support body comprises a first segment, which is located on one side of the first support body and has a non-linear configuration; the first segment intersects the first edge at a first intersection point and intersects the second edge at a second intersection point; the second support body is connected with the first support body and allows the first segment to rotate relative to the first support body around a line connecting the first intersection point and the second intersection point; the artificial valve leaflet is connected with the edge of the second support body located on the side close to the first end and the first segment; the heart valve prosthesis has a contracted state and an expanded state; when the heart valve prosthesis switches from the contracted state to the expanded state, the first segment rotates and drives the middle part of the first segment to move in the direction close to the first end, and the distance between the middle part of the first segment and the first support body increases; when the heart valve prosthesis is in the expanded state, the area of the cross section of the artificial valve prosthesis perpendicular to the first direction first increases and then decreases along the first direction. The heart valve prosthesis can replace the native atrioventricular valve and / or the native arterial valve and has a larger effective valve orifice area.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to a heart valve prosthesis. BACKGROUND

[0002] The heart comprises four chambers, namely a left atrium, a left ventricle, a right atrium and a right ventricle. Among them, the left atrium and the left ventricle are located on the left side, and the right atrium and the right ventricle are located on the right side. The atrium and the ventricle on the same side form a ventricular inflow tract, and the ventricular inflow tract forms an atrioventricular valve. Specifically, the left atrium and the left ventricle form a mitral valve, and the right atrium and the right ventricle form a tricuspid valve. The ventricle and the artery form a ventricular outflow tract, and the ventricular outflow tract forms an arterial valve. Specifically, the left ventricular outflow tract forms an aortic valve, and the right ventricular outflow tract forms a pulmonary valve. The atrioventricular valve and the arterial valve both function as a one-way valve to ensure normal blood flow. When any atrioventricular valve and / or arterial valve has a problem, the cardiac hemodynamics will change accordingly, leading to abnormal heart function and causing valvular heart disease.

[0003] The incidence of valvular heart disease increases significantly with age. Studies have shown that the incidence of valvular heart disease in people over 75 years old is as high as 13%. Currently, the treatment options for valvular heart disease include traditional surgical operation and transcatheter valve replacement. Traditional surgical operation has the disadvantages of high risk and high mortality, and is not suitable for patients who are old, have multiple organ diseases, have a history of thoracotomy, and have poor heart function. Transcatheter valve replacement has received widespread attention from experts and scholars due to its advantages of no need for thoracotomy, small trauma, and fast recovery of patients.

[0004] Although the heart valve prosthesis has made great progress, there are still some problems to be solved, for example, after the artificial heart valve is implanted in the heart, multiple components are located at the native valve annulus, which leads to the problem of small effective orifice area (EOA) of the heart valve prosthesis. In addition, the size of the existing artificial heart valve after compression is large, which is easy to cause damage to the blood vessels during the intervention process. SUMMARY

[0005] The purpose of the present application is to provide a heart valve prosthesis, which aims to increase the effective orifice area while reducing the compression size and reducing the damage to the blood vessels during the intervention process.

[0006] To achieve the above-mentioned purpose, the present application provides a heart valve prosthesis having a first end and a second end opposite in a first direction, comprising:

[0007] a first support body having a first edge and a second edge opposite in a second direction, the second direction being perpendicular to the first direction;

[0008] a second support body comprising a first segment; the first segment is located at one side of the second support body and has a non-straight configuration; the first segment intersects the first edge at a first intersection point and intersects the second edge at a second intersection point; the second support body is connected to the first support body and allows the first segment to rotate relative to the first support body about a line connecting the first intersection point and the second intersection point; and

[0009] a prosthetic leaflet connected to the first support body at an edge of the second support body close to the first end and the first segment;

[0010] the heart valve prosthesis has a contracted state and an expanded state; when the heart valve prosthesis switches from the contracted state to the expanded state, the first segment rotates and drives the middle part of the first segment to move in a direction close to the first end, and the distance between the middle part of the first segment and the first support body increases; when the heart valve prosthesis is in the expanded state, the area of the cross section of the heart valve prosthesis perpendicular to the first direction first increases and then decreases along the first direction.

[0011] Optionally, when the heart valve prosthesis is in the expanded state, the area of the cross section of the heart valve prosthesis perpendicular to the first direction at the second end is greater than the area of the cross section of the heart valve prosthesis perpendicular to the first direction at the first end.

[0012] Optionally, the distance between the first edge and the second edge remains constant; or the distance between the first edge and the second edge increases in the direction from the first end to the second end.

[0013] Optionally, the line connecting the first intersection point and the second intersection point extends in the second direction.

[0014] Optionally, a second plane intersects the line connecting the first intersection point and the second intersection point at a fourth intersection point, and the second plane also intersects the first segment at a third intersection point; the second plane is parallel to the first direction and perpendicular to the line connecting the first intersection point and the second intersection point; a ray extending from the fourth intersection point in the direction from the first end to the second end and the line connecting the fourth intersection point and the third intersection point form an object angle;

[0015] When the heart valve prosthesis is in the contracted state, the angle of the object angle is greater than 0° and less than or equal to 30°; when the heart valve prosthesis is in the expanded state, the angle of the object angle is greater than or equal to 75° and less than or equal to 105°.

[0016] Optionally, the second support body further comprises a second segment, the second segment being connected to the first segment in a head-to-tail manner; the second segment is in a straight line configuration and is located on a line connecting the first intersection point and the second intersection point; the second segment is connected to the first support body.

[0017] Optionally, the first segment is in any one of an arc shape, a "L" shape and a U shape.

[0018] Optionally, when the heart valve prosthesis is in the expanded state, a center angle formed by a center of a circle on which projections of the first support body and the artificial valve leaflets are located and the center of the circle is less than or equal to 120° in a plane perpendicular to the first direction.

[0019] Optionally, the first support body comprises a support base, the support base comprising a plurality of support rods connected in a head-to-tail manner and forming a ring structure; one of the plurality of support rods is a first support rod and another one of the plurality of support rods is a second support rod, the first support rod and the second support rod both extend along the first direction, and the first support rod and the second support rod are arranged along the second direction; the first edge is located at the first support rod and the second edge is located at the second support rod; or the support body comprises a sheet structure.

[0020] Optionally, the first support body further comprises a cladding layer, the cladding layer being connected to the support base and covering all regions where the support base is located.

[0021] Compared with the prior art, the heart valve prosthesis has the following advantages:

[0022] The aforementioned heart valve prosthesis has a first end and a second end opposite in a first direction; the heart valve prosthesis comprises a first support body, a second support body and an artificial valve leaflet; the first support body has a first edge and a second edge opposite in a second direction, the second direction being perpendicular to the first direction; the second support body comprises a first segment, the first segment being located on one side of the first support body, and the first segment being in a non-linear configuration; the first segment intersects the first edge at a first intersection point, and the first segment also intersects the second edge at a second intersection point; the second support body is connected with the first support body, and allows the first segment to rotate relative to the first support body about a line connecting the first intersection point and the second intersection point; the artificial valve leaflet is connected with the first support body on an edge of the second support body close to the first end and the first segment; the heart valve prosthesis has a contracted state and an expanded state; when the heart valve prosthesis switches from the contracted state to the expanded state, the first segment rotates and drives a middle part of the first segment to move in a direction close to the first end, and the distance between the middle part of the first segment and the first support body is increased; when the heart valve prosthesis is in the expanded state, the area of a cross section of the artificial valve prosthesis perpendicular to the first direction first increases and then decreases along the first direction. When the heart valve prosthesis is used to replace a native atrioventricular valve and / or a native arterial valve, and the heart valve prosthesis is in the contracted state, blood is allowed to flow from a region between the native tissue and a side of the artificial valve leaflet away from the first support body, so that the heart valve prosthesis has a larger effective valve orifice area. At the same time, the heart valve prosthesis has a smaller outer diameter when being compressed, which can effectively reduce the pushing resistance in the intervention process and also reduce the damage to the blood vessels.

[0023] Further, when the heart valve prosthesis is used to replace a native aortic valve, by controlling the setting position of the entire heart valve prosthesis, the heart valve prosthesis can be effectively prevented from blocking the coronary artery orifice, thereby avoiding the problem of coronary artery occlusion. BRIEF DESCRIPTION OF DRAWINGS

[0024] The accompanying drawings are used to better understand the present application, and do not constitute an improper limitation on the present application. Among them:

[0025] Figure 1 is a structural schematic view of a heart valve prosthesis provided by the present application according to an embodiment, the heart valve prosthesis in the view is in an expanded state;

[0026] Figure 2 is a structural schematic view of a heart valve prosthesis provided by the present application according to an embodiment, the heart valve prosthesis in the view is in an expanded state, and Figure 2 and Figure 1The observation direction is different;

[0027] Figure 3 is a structural schematic diagram of a heart valve prosthesis provided by the present application according to an embodiment, and the heart valve prosthesis in the diagram is in a contracted state;

[0028] Figure 4 is a schematic diagram of an application scenario of a heart valve prosthesis provided by the present application according to an embodiment, and the heart valve prosthesis in the diagram is in a contracted state;

[0029] Figure 5 is a schematic diagram of an application scenario of a heart valve prosthesis provided by the present application according to an embodiment, and the heart valve prosthesis in the diagram is in an inflated state;

[0030] Figure 6 is a schematic diagram of an application scenario of a heart valve prosthesis provided by the present application according to an embodiment, and the heart valve prosthesis in the diagram replaces a native aortic valve, and the heart valve prosthesis is in an inflated state;

[0031] Figure 7 is a partial structural schematic diagram of a heart valve prosthesis provided by the present application according to an embodiment, and a first support body is shown in the diagram, but a coating layer is not shown;

[0032] Figure 8 is a partial structural schematic diagram of a heart valve prosthesis provided by the present application according to an embodiment, and a first support body is shown in the diagram;

[0033] Figure 9 is a partial structural schematic diagram of a heart valve prosthesis provided by the present application according to another embodiment, and a first support body is shown in the diagram, but a coating layer is not shown;

[0034] Figure 10 is a partial structural schematic diagram of a heart valve prosthesis provided by the present application according to another embodiment, and a first support body is shown in the diagram;

[0035] Figure 11 is a partial structural schematic diagram of a heart valve prosthesis provided by the present application according to another embodiment, and a first support body is shown in the diagram, but a coating layer is not shown;

[0036] Figure 12 is a partial structural schematic diagram of a heart valve prosthesis provided by the present application according to another embodiment, and a first support body is shown in the diagram;

[0037] Figure 13 is a partial structural schematic diagram of a heart valve prosthesis provided by the present application according to an embodiment, and a second support body is shown in the diagram;

[0038] Figure 14is a schematic diagram of a partial structure of a heart valve prosthesis according to another embodiment of the present application, showing a second support body;

[0039] Figure 15 is a schematic diagram of a partial structure of a heart valve prosthesis according to another embodiment of the present application, showing a second support body.

[0040] [The following reference signs are used:]

[0041] 10 - heart valve prosthesis, 11 - first end, 12 - second end, 13 - reference position, 100 - first support body, 101 - first edge, 102 - second edge, 110 - support base, 111 - support rod, 111a - first support rod, 111b - second support rod, 112 - reinforcing rod, 120 - covering layer, 200 - second support body, 210 - first segment, 220 - second segment, 300 - artificial valve leaflet,

[0042] 01 - first connecting line, 02 - blood flow passage, 03 - coronary artery orifice, 04 - first plane, 05 - second plane, 06 - second connecting line. DETAILED DESCRIPTION

[0043] Other advantages and effects of the present application can be easily understood by those skilled in the art from the above description. The present application can also be implemented or applied in other different embodiments, and the details in the description can be modified or changed based on different views and applications without departing from the spirit of the present application. It should be noted that the drawings provided in the present embodiment only schematically illustrate the basic concept of the present application, and thus the drawings only show the components related to the present application without showing the number, shape and size of the components in actual implementation. The type, number and ratio of the components in actual implementation can be arbitrarily changed, and the layout type of the components can be more complex.

[0044] In addition, each of the embodiments described below has one or more technical features, but this does not mean that the user of the present application must simultaneously implement all the technical features in any embodiment, or can only separately implement one or more technical features in different embodiments. In other words, under the premise of implementation, those skilled in the art can selectively implement part or all of the technical features in any embodiment, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present application, according to the disclosure of the present application and the design specification or implementation requirements.

[0045] As used in this specification, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense of "and / or" unless the content clearly dictates otherwise, and the term "have" or "has" is generally employed in its sense of "have or has at least one" or "has or has at least one" unless the content clearly dictates otherwise. The term "mounting", "connected", "connection" should be given broadest interpretation, for example, can be fixed connection, can also be detachable connection, or integrally connected. It can be mechanical connection, or electrical connection. It can be directly connected, or indirectly connected through an intermediate medium, it can be internal communication of two elements or interaction relationship between two elements. The relationship terms such as "first", "second" and the like are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between the entities or operations, nor indicate or imply relative importance or implicitly indicate the number of technical features indicated. It should be understood that the orientation or positional relationship indicated by the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "axial", "radial", "circumferential" and the like are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as limiting the present application. The specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0046] The present application aims to provide a heart valve prosthesis with the advantages of large effective orifice area and small outer diameter when crimped.

[0047] In order to make the purpose, advantages and characteristics of the present application clearer, the present application will be further described in detail below in combination with the drawings. It should be noted that the drawings are all very simplified and use non-precise proportions, and are only used to facilitate and clarify the purpose of assisting the description of the embodiments of the present application. The same or similar reference numerals in the drawings represent the same or similar parts.

[0048] Figures 1 to 3 A structural schematic diagram of a heart valve prosthesis 10 provided by an embodiment of the present application is shown. Figures 7 to 12 is a partial structural schematic diagram of the heart valve prosthesis 10; Figures 13 to 15 is a partial structural schematic diagram of another part of the heart valve prosthesis 10.

[0049] Please refer to Figures 1 to 3 , Figures 7 to 15, the heart valve prosthesis 10 has a first end 11 and a second end 12 opposite in a first direction. The first direction is identified by a bidirectional arrow X in the illustration. The heart valve prosthesis 10 further comprises a first support body 100, a second support body 200 and an artificial valve leaflet 300.

[0050] The first support body 100 extends along the first direction and has a first edge 101 and a second edge 102 opposite in a second direction. The second direction is perpendicular to the first direction, and is identified by a bidirectional arrow Y in the illustration.

[0051] The second support body 200 comprises a first segment 210 located at one side of the first support body 100 and having a non-straight configuration. The first segment 210 intersects the first edge 101 at a first intersection point A1 and intersects the second edge 102 at a second intersection point A2. A line connecting the first intersection point A1 and the second intersection point A2 is a first line 01. The second support body 200 is rotationally connected with the first support body 100 and allows the first segment 210 to rotate relative to the first support body 100 about the first line 01. Figure 2 In the illustrated embodiment, the first line 01 is visually coincident with the first support body 100, the first edge 101 is visually coincident with the first intersection point A1, and the second edge 102 is visually coincident with the second intersection point A2.

[0052] The artificial valve leaflet 300 is connected with the first support body 100 at an edge of the second support body 200 close to the first end 11. The artificial valve leaflet 300 is also connected with the first segment 210. In this way, the first end 11 of the heart valve prosthesis 10 is a closed end, and the second end 12 of the heart valve prosthesis 10 is an open end, and the profile of the opening is defined by the first segment 210.

[0053] The heart valve prosthesis 10 has an expanded state as shown in Figure 1 and Figure 2 and a contracted state as shown in Figure 3 When the heart valve prosthesis 10 is in the contracted state, the distance from the middle of the first segment 210 to the first support body 100 is L1, and when the heart valve prosthesis 10 is in the expanded state, the distance from the middle of the first segment 210 to the first support body 100 is L2, and L2 is greater than L1. The middle of the first segment 210 refers to a position of the first segment 210 between the first intersection point A1 and the second intersection point A2, which can be the midpoint of the first segment 210 or a position near the midpoint of the first segment 210.

[0054] In the process of switching the heart valve prosthesis 10 from the contracted state to the expanded state, the first segment 210 rotates around the first connecting line 01 in a third direction, and drives the middle part of the first segment 210 to move in a direction close to the first end 11, and increases the distance between the middle part of the first segment 210 and the first support body 100 from a smaller L1 to a larger L2. When the heart valve prosthesis 10 is switched from the expanded state to the contracted state, the first segment 210 rotates around the first connecting line 01 in a fourth direction opposite to the third direction, and drives the middle part of the first segment 210 to move in a direction close to the second end 12, and reduces the distance between the middle part of the first segment 210 and the first support body 100 from the larger L2 to the smaller L1. In other words, by switching the artificial valve prosthesis 10 from the contracted state to the expanded state, the distance between the middle part of the first segment 210 and the first support body 100 is increased, and by switching the artificial valve prosthesis from the expanded state to the contracted state, the distance between the middle part of the first segment 210 and the first support body 100 is reduced.

[0055] Here, in the Figure 1 and Figure 3 shown orientation, the third direction is the counterclockwise direction shown by the single-headed arrow S1 in Figure 3 , and the fourth direction is the clockwise direction shown by the single-headed arrow S2 in Figure 1 .

[0056] It should be noted that there are two conditions for switching the heart valve prosthesis 10 from the contracted state to the expanded state, one is to rotate the first segment 210 in the fourth direction to the distance between the middle part of the first segment 210 and the first support body 100 is L2, and the other is to inject perfusion liquid between the artificial valve leaflet 300 close to the first support body 100. The perfusion of the perfusion liquid is carried out during the rotation of the first segment 210 in the fourth direction, and / or after the rotation of the first segment 210 in the fourth direction.

[0057] Please refer to Figure 1When the heart valve prosthesis 10 is in the expanded state, the area of the cross section of the heart valve prosthesis 10 perpendicular to the first direction increases first and then decreases along the first direction. That is, the area of the cross section of the heart valve prosthesis 10 perpendicular to the first direction increases first and then decreases along the direction from the first end 11 to the second end 12, or in other words, the area of the cross section of the heart valve prosthesis 10 perpendicular to the first direction increases first and then decreases along the direction from the second end 12 to the first end 11. Hereinafter, for the convenience of description, the cross section of the heart valve prosthesis 10 perpendicular to the first direction is referred to as a transverse cross section.

[0058] In other words, the heart valve prosthesis 10 has a reference position 13. In the first direction, the reference position 13 is located between the first end 11 and the second end 12, and the area of the transverse cross section of the heart valve prosthesis 10 decreases along the direction away from the reference position 13. That is, the heart valve prosthesis 10 has a structure of small ends and a large middle, and has the largest transverse cross-sectional area at the reference position 13.

[0059] As known by those skilled in the art, the artificial valve leaflet 300 is generally made of soft biological tissue, and when the heart valve prosthesis 10 is applied, the first direction is generally vertical. Thus, for the heart valve prosthesis 10 in the expanded state, under the action of the perfusion liquid, the profile line of the artificial valve leaflet 300 on the transverse cross section at the reference position 13 is a circular arc. The material used to make the artificial valve leaflet 300 should have relatively stable chemical properties, and optional materials include but are not limited to at least one of pig pericardium, cow pericardium, sheep pericardium, horse pericardium, and animal small intestinal submucosa. In addition, the artificial valve leaflet 300 is a relatively large sheet structure, and can also be connected by a plurality of smaller sheet structures.

[0060] The heart valve prosthesis 10 can be applied to the treatment of valvular heart disease to replace the native valve (i.e., at least one of the native mitral valve, the native tricuspid valve, the native aortic valve, and the native pulmonary valve) to function as a one-way valve, at which time the perfusion liquid is blood, and the perfusion of blood is performed during and after the rotation of the first segment 210 in the fourth direction.

[0061] Figure 4 and Figure 5 A schematic view of the scenario in which the heart valve prosthesis 10 replaces the native valve is shown, as shown in Figure 4 and Figure 5 As shown in the drawings, the first edge 101 and the second edge 102 of the first support body 100 abut the native tissue (at the Figure 4 and Figure 5In the shown orientation, the first support body 100, the first edge 101 and the second edge 102 are visually coincident, and the prosthetic heart valve 10 is kept in the contracted state during diastole and in the expanded state during systole. Thus, during diastole, the middle part of the first section 210 is at a small distance (L1) from the first support body 100, so that the blood flow passage 02 is formed between the side of the artificial leaflet 300 facing away from the first support body 100 and the native tissue, allowing blood to flow through the blood flow passage 02 in the direction from the first end 11 to the second end 12, for the purpose of blood flow from the ventricle to the artery or from the atrium to the ventricle. During the transition from diastole to systole, the distance between the middle part of the first section 210 and the first support body 100 increases to L2, and blood at least partially flows from the first section 210 into the side of the artificial leaflet 300 close to the first support body 100, causing the artificial leaflet 300 to be expanded, so that the prosthetic heart valve 10 is switched to the expanded state. At this time, the artificial leaflet 300 abuts against the native tissue at least at the reference position 13 and blocks the blood flow passage 02 in the direction from the second end 12 to the first end 11, so as to prevent blood from flowing in the direction from the artery to the ventricle or from the ventricle to the atrium, thereby reducing paravalvular leakage. Since the prosthetic heart valve 10 provided by the embodiment of the present application has fewer components, the cross section of the blood flow passage 02 formed by the prosthetic heart valve 10 in the contracted state can be larger, so as to allow sufficient blood to enter the artery or the ventricle during diastole. In addition, the prosthetic heart valve 10 with fewer components has a smaller outer diameter when crimped, so that the resistance to delivery during the interventional operation is correspondingly smaller, and the blood vessel is less likely to be damaged.

[0062] It should be understood that, when the prosthetic heart valve 10 is in the expanded state, the maximum distance D1 from the artificial leaflet 300 to the first support body 100 at the reference position 13 should be not less than the inner diameter D2 of the implantation site, so that the artificial leaflet 300 abuts against the native tissue at least at the reference position 13. In particular, when D1 is greater than D2, the artificial leaflet 300 forms a structure similar to an interference fit between the reference position 13 and the native tissue for the prosthetic heart valve 10 in the expanded state, which can better block the blood flow passage 02 and reduce paravalvular leakage.

[0063] It should also be particularly pointed out that, when the prosthetic heart valve 10 provided by the embodiment of the present application is used to replace the native aortic valve, the first support body 100 is located at the coronary orifice 03 (such as the coronary orifice 03 in FIG. 1), and the second support body 200 is located at the aortic orifice 04 (such as the aortic orifice 04 in FIG. 1). Figure 6The reference position 13 is located on the side of the coronary artery ostium 03 close to the ventricle. In this way, the heart valve prosthesis 10 in the expanded state does not block the coronary artery ostium 03, effectively ensuring the blood perfusion of the coronary artery.

[0064] Please refer to Figure 2 , a first plane 04 is defined, which is perpendicular to the first direction. When the heart valve prosthesis 10 in the expanded state is projected onto the first plane 04, the angle of the center angle β formed by the center of the circle where the projection of the first support body 100 and the projection of the artificial valve leaflet 300 are located and the center O is less than or equal to 120°. In this way, when the heart valve prosthesis 10 is used to replace the native aortic valve, the first support body 100 can be circumferentially offset from the coronary artery ostium 03.

[0065] In practice, the cross-sectional area of the blood flow passage 02 is set as needed. Please refer to Figures 1 to 3 , a second plane 05 is defined, which is parallel to the first direction and also perpendicular to the first line 01. The second plane 05 intersects the first line 01 at a fourth intersection point A4, and the second plane 05 also intersects the first segment 210 at a third intersection point A3. The line connecting the third intersection point A3 and the fourth intersection point A4 is a second line 06. The second line 06 is located on the second plane 05, and in Figure 1 , the second line 06 is visually coincident with the second segment 210, and the fourth intersection point A4 is visually coincident with the first intersection point A1 and the second intersection point A2, and in Figure 2 , the second line 06 is visually coincident with the second plane 05. The angle between the ray extending from the fourth intersection point A4 and in the direction from the first end to the second end and the second line 06 is defined as the target angle α. When the heart valve prosthesis 10 is in the contracted state, the cross-sectional area of the blood flow passage 02 is related to the angle of the target angle α, specifically, under the condition that other parameters are fixed, the cross-sectional area of the blood flow passage 02 is inversely proportional to the target angle α. That is, when the heart valve prosthesis 10 is in the contracted state, the smaller the angle of the target angle α, the larger the cross-sectional area of the blood flow passage 02, and the larger the angle of the target angle α, the smaller the cross-sectional area of the blood flow passage 02. Alternatively, when the heart valve prosthesis is in the contracted state, the angle of the target angle α is greater than 0° and less than or equal to 30°, for example, 5°, 10°, 12°, 15°, 18°, 20°, 25°, 30°, etc.

[0066] When the heart valve prosthesis 10 is in the expanded state, the angle of the target included angle a can be greater than or equal to 75° and less than or equal to 105°, and optional angles include but are not limited to any of 75°, 78°, 80°, 90°, 95°, 100°, 103°, 105°. As a preferred, the angle of the target included angle a in the heart valve prosthesis in the expanded state is 90°, which is most conducive to blood perfusion.

[0067] In addition, the distance D3 between the midpoint of the first segment 210 and the midpoint of the first line 01 should be less than D2. Such a setting can ensure that the first segment 210 is always not in contact with the native tissue, on the one hand, to avoid endothelialization of the first segment 210, which can cause the first segment 210 to be unable to rotate, on the other hand, to avoid damage to the native tissue during rotation, and on the other hand, to ensure that the part of the heart valve prosthesis 10 located on the side of the reference position 13 close to the second end 12 does not block the coronary artery orifice when the heart valve prosthesis 10 replaces the native aortic valve and the reference position 13 is located on the side of the coronary artery orifice close to the ventricle. It should be noted that when the heart valve prosthesis 10 is in the expanded state, if the angle of the target included angle a is 90°, and the middle part of the first segment 210 is the midpoint of the first segment 210, then L2 is equal to D3. Figure 1 and Figure 3 In the orientation shown, the midpoint of the first segment 210 and the third intersection A3 coincide visually, and the midpoint of the first line 01 and the first intersection A1, the second intersection A2, and the fourth intersection A4 coincide visually. In fact, when the second plane 05 passes through the midpoint of the first segment 210 and the midpoint of the first line 01, the midpoint of the first segment 210 is the third intersection A3, and the midpoint of the first line 01 is the fourth intersection A4.

[0068] Further, when the heart valve prosthesis 10 is in the expanded state, the cross-sectional area of the heart valve prosthesis 10 at the second end 12 is greater than the cross-sectional area of the heart valve prosthesis 10 at the first end 11. The advantage of such a setting is that when the heart switches from the systole to the diastole, the blood can flow more smoothly along the first end 11 towards the second end 12, and the blood located on the side of the artificial valve leaflet 300 close to the first support body 100 is pushed out, and the first segment 210 is pushed to rotate along the fourth direction, achieving the switching of the heart valve prosthesis 10 from the expanded state to the contracted state, while reducing the transvalvular pressure difference.

[0069] Next, other configurations of the heart valve prosthesis 10 will be described.

[0070] Optionally, the first support body 100 comprises a support base 110 (as shown in Figure 7 , Figure 9 and Figure 11 ). The support base 110 can comprise a ring structure, or a sheet structure.

[0071] When the support base 110 comprises the ring structure, the support base 110 comprises a plurality of support rods 111 which are connected end to end in sequence and form a ring structure, as shown in Figure 7 , Figure 9 and Figure 11 . One of the plurality of support rods 111 is a first support rod 111a, and another is a second support rod 111b. The first support rod 111a and the second support rod 111b both extend in the first direction, and the first support rod 111a and the second support rod 111b are arranged in the second direction. The first edge 101 is located at the first support rod 111a, and the second edge 102 is located at the second support rod 111b. Here, “the first support rod 111a and the second support rod 111b both extend in the first direction” means that the first support rod 111a has two opposite ends in the first direction, and the second support rod 111b has two opposite ends in the first direction, which does not mean that the first support rod 111a extends in a straight line in the first direction, or that the second support rod 111b extends in a straight line in the first direction. In practice, the first support rod 111a can extend in a straight line (as shown in Figure 7 and Figure 9 ), or at least partially extend in a curve (as shown in Figure 11 ), and the second support rod 111b can extend in a straight line (as shown in Figure 7 and Figure 9 ), or at least partially extend in a curve (as shown in Figure 11 ).

[0072] Optionally, the support base 110 can further comprise a reinforcing rod 112, as shown in Figure 11 . The two ends of the reinforcing rod 112 are respectively connected to two different support rods 111.

[0073] When the support base 110 comprises the sheet structure, the sheet structure can be a planar sheet structure, or a curved sheet structure. The first edge 101 and the second edge 102 are respectively at two opposite edges of the sheet structure in the first direction.

[0074] The support base 110 can be made of nickel-titanium alloy, titanium alloy, cobalt-chromium alloy, non-magnetic nickel-cobalt-chromium-molybdenum alloy, 316 stainless steel, other materials with good biocompatibility and good resilience, or can be made of plastically deformable or elastically deformable materials such as balloon expandable materials. The support base 110 can be cut or woven.

[0075] In some embodiments, the first support body 100 not only includes the support base 110, but also includes a coating layer 120 (as shown in Figure 8 、 Figure 10 and Figure 12 When the support base 110 is in the ring structure, the coating layer 120 covers part of the structure of each support rod 111 and also covers the area enclosed by the support base 110. When the support base 110 includes a sheet structure, the coating layer 120 covers the entire support base 110. The coating layer 120 is provided to promote the endothelialization process of the first support body 100 and reduce blood leakage at the first support body 100 when the first support body 100 is not completely endothelialized.

[0076] The material of the coating layer 120 is not particularly limited in the embodiments of the present application and can be polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), polyurethane (PU), or other materials with similar properties.

[0077] In addition, in some optional embodiments, the distance between the first edge 101 and the second edge 102 remains constant, as shown in Figure 7 and Figures 8 to 12 In this case, a plurality of support rods 111 can be connected to form a rectangular structure. In other optional embodiments, as shown in Figures 13 to 15 the distance between the first edge 101 and the second edge 102 increases in the direction from the first end 11 to the second end 12. For example, the projection of the first support body 100 in the direction parallel to the first direction and the second direction is a triangle or a triangle-like shape.

[0078] In addition, the first support body 100 can also be provided with a connection part (not shown in the figure), which is used for connection of a delivery system.

[0079] Please refer to Figure 13The second support 200 further includes a second segment 220. The second segment 220 is connected end-to-end to the first segment 210, forming a ring structure. The second segment 200 is a straight line and lies on line O1 connecting the first intersection point A1 and the second intersection point A2. In practice, the second segment 220 is connected to the first support 100, allowing the first segment 210 to rotate around the second segment 220. The connection method between the second segment 220 and the first support 100 is not limited; options include, but are not limited to, hinged connections and connections via connecting rods.

[0080] Furthermore, the first segment 210 can be as follows: Figure 14 The arc-shaped structure shown, such as a circular arc structure, makes the second support 200 approximately "D" shaped. Alternatively, the first segment 210 may be as follows: Figure 15 The "]" shaped structure shown makes the second support 200 a rectangular structure. Alternatively, the first segment 210 is... ​ The U-shaped structure shown can also be any other suitable shape. In a preferred embodiment, the first connecting line 01 extends along the second direction. Thus, the target included angle α is the dihedral angle formed by the plane containing the second support 200 and the planes containing the first edge 101 and the second edge 102.

[0081] The embodiments of the present invention do not specifically limit the material used to manufacture the second support 200. Optional materials include, but are not limited to, at least one of nickel-titanium alloy, titanium alloy, cobalt-chromium alloy, non-magnetic nickel-cobalt-chromium-molybdenum alloy, and 316 stainless steel. Furthermore, preferably, the second support 102 is connected to the first support 100 at the location of the outflow end 12.

[0082] The artificial leaflet 300 can be connected to the first support 100 by suturing, gluing, or any other suitable method. The artificial leaflet 300 can be connected to the second support 200 by suturing, gluing, or any other suitable method.

[0083] While the present invention has been disclosed above, it is not limited thereto. Those skilled in the art can make various modifications and variations to the present invention without departing from its spirit and scope. Therefore, if such modifications and variations fall within the scope of the claims and their equivalents, the present invention also intends to include such modifications and variations.

Claims

1. A heart valve prosthesis having a first end and a second end opposite in a first direction, characterized in that, The heart valve prosthesis comprises: a first support body having a first edge and a second edge opposite to each other in a second direction perpendicular to a first direction; a second support body comprising a first section; the first section is located on one side of the first support body and has a non-linear configuration; the first section intersects the first edge at a first intersection point and intersects the second edge at a second intersection point; the second support body is connected to the first support body and allows the first section to rotate relative to the first support body about a line connecting the first intersection point and the second intersection point; and an artificial valve leaflet connected to the first support body at an edge of the second support body close to the first end and the first section, so that the first end of the heart valve prosthesis is a closed end and the second end is an open end; the heart valve prosthesis has a contracted state and an expanded state; when the heart valve prosthesis switches from the contracted state to the expanded state, the first section rotates and drives the middle part of the first section to move in a direction close to the first end, and the distance between the middle part of the first section and the first support body increases; when the heart valve prosthesis is in the expanded state, the area of the cross section of the heart valve prosthesis perpendicular to the first direction first increases and then decreases along the first direction.

2. The heart valve prosthesis of claim 1, characterized in that When the heart valve prosthesis is in the expanded state, the area of the cross section of the heart valve prosthesis perpendicular to the first direction at the second end is greater than the area of the cross section of the heart valve prosthesis perpendicular to the first direction at the first end.

3. The heart valve prosthesis of claim 1, characterized in that The distance between the first edge and the second edge remains constant; or the distance between the first edge and the second edge increases in a direction from the first end to the second end.

4. The heart valve prosthesis of claim 1, characterized in that The line connecting the first intersection point and the second intersection point extends in the second direction.

5. The heart valve prosthesis of claim 1 or 4, characterized in that A second plane intersects the line connecting the first intersection point and the second intersection point at a fourth intersection point, and intersects the first section at a third intersection point; the second plane is parallel to the first direction and perpendicular to the line connecting the first intersection point and the second intersection point; a ray extending from the fourth intersection point in a direction from the first end to the second end forms an object angle with the line connecting the fourth intersection point and the third intersection point; When the heart valve prosthesis is in the contracted state, the angle of the object angle is greater than 0° and less than or equal to 30°; when the heart valve prosthesis is in the expanded state, the angle of the object angle is greater than or equal to 75° and less than or equal to 105°.

6. The heart valve prosthesis of claim 1, characterized in that The second support body further comprises a second section; the second section is connected to the first section in a head-to-tail manner; the second section has a linear configuration and is located on the line connecting the first intersection point and the second intersection point; and the second section is connected to the first support body.

7. The heart valve prosthesis of claim 1 or 6, characterized in that The first section has any one of an arc shape, a "L" shape, and a U shape.

8. The heart valve prosthesis of claim 1, characterized in that When the heart valve prosthesis is in the expanded state, a center angle formed by a projection of the first support body and a center of a circle in which projections of the artificial valve leaflets lie is less than or equal to 120° in a plane perpendicular to the first direction.

9. The heart valve prosthesis of claim 1, characterized in that The first support body comprises a support base, the support base comprising a plurality of support rods connected end to end and forming a ring structure; one of the plurality of support rods is a first support rod, and another is a second support rod; the first support rod and the second support rod both extend along the first direction, and the first support rod and the second support rod are arranged along the second direction; the first edge is located at the first support rod, and the second edge is located at the second support rod; or the support body comprises a sheet structure.

10. The heart valve prosthesis of claim 9, characterized in that The first support body further comprises a cladding layer, the cladding layer being connected with the support base and covering all areas where the support base is located.

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