Single-leaflet mechanical valve

Abstract

A single-leaflet mechanical valve, comprising a mechanical valve annulus (1), a limiting base (2), a movable valve leaflet (3), and a guide rod (4), wherein a connection hole (101) is provided in the middle of the mechanical valve annulus (1); the limiting base (2) is mounted at the bottom of the mechanical valve annulus (1), and an open movement region (201) is provided between the mechanical valve annulus (1) and the limiting base (2); and the movable valve leaflet (3) and the guide rod (4) are both located in the movement region (201), and the movable valve leaflet (3) can perform a reciprocating motion vertically along the trajectory direction of the guide rod (4), such that the movable valve leaflet (3) can movably open or close the entire channel opening of the connection hole (101), thereby relatively increasing the orifice area and achieving a lower transvalvular pressure gradient. By means of cooperation of the movable valve leaflet (3) and the guide rod (4), the mechanical valve can effectively avoid thrombosis, and is not easily damaged; and even if thrombosis occurs, the mechanical valve is not easily stuck, thus avoiding the risk of valve sticking or dysfunction, and enabling the reduction or elimination of anticoagulant therapy.

Description

A single-leaflet mechanical valve TECHNICAL FIELD

[0001] The present application relates to the technical field of mechanical valve, and in particular to a single-leaflet mechanical valve. BACKGROUND

[0002] Among heart disease patients, especially the lesions of mitral valve, aortic valve, tricuspid valve and pulmonary valve, are often accompanied by congenital malformation or later acquired stenosis, insufficiency and other problems, which further cause heart failure and lead to systemic or pulmonary circulation congestion. Clinically, such patients show symptoms such as shortness of breath, palpitation, fatigue, abdominal distension, and lower extremity edema after exercise. If not treated in time, the condition may worsen rapidly, and even develop into heart failure, so that the patient can only choose artificial heart implantation or wait for heart transplantation. At present, the main treatment methods for valve lesions include valve repair and valve replacement surgery.

[0003] In valve replacement, the commonly used artificial valve in clinic is divided into two categories: mechanical valve and biological valve. For patients without atrial fibrillation, the anticoagulant therapy time after biological valve replacement is usually half a year. However, the service life of biological valve is limited, generally 3 to 15 years, and with the increase of use time, there is a risk of decay and damage, especially not suitable for young patients. Mechanical valve becomes a common choice due to its long-term durability, but requires lifelong anticoagulant therapy. Whether it is a single-leaflet, double-leaflet or triple-leaflet mechanical valve, there is a risk of organ bleeding during anticoagulant therapy, such as cerebral hemorrhage, gastrointestinal bleeding, excessive growth of vascular overgrowth, loss of valve orifice area, and even dysfunction, which requires reoperation. At the same time, insufficient anticoagulation may lead to thrombosis, causing valve dysfunction or embolism, further increasing the risk of complications such as valve jamming and cerebral infarction. For some small annulus or low weight patients, due to the small size of the annulus, the existing mechanical valve and biological valve cannot meet the implantation requirements. Such patients usually need to take annulus enlargement or choose a larger size valve for implantation, which not only increases the difficulty of surgery, but also leads to a significant increase in transvalvular pressure difference, affecting the heart function of the patient and possibly shortening the service life of the valve. Especially in small annulus patients, oversized valves increase the risk of valve dysfunction, which further affects the treatment effect.

[0004] Therefore, the existing mechanical valve and biological valve still have many problems when applied to small annulus or low weight patients, and a new type of valve that can solve these limitations is urgently needed. SUMMARY

[0005] The present application aims to provide a single-leaf mechanical valve, which can be used for a long time, avoids valve clamping or dysfunction, and does not require or only requires low anticoagulant therapy, and has a larger valve opening area (the opening area of the same type of valve is obviously larger than that of existing mechanical valves and biological valves).

[0006] In order to achieve the above-mentioned purpose, the technical scheme adopted by the present application is as follows:

[0007] The present application provides a single-leaf mechanical valve, which comprises:

[0008] A mechanical valve ring having a through hole in the middle;

[0009] A limiting base installed at the bottom of the mechanical valve ring, wherein an open movable area is provided between the mechanical valve ring and the limiting base, the top of the movable area is communicated to the through hole and forms a blood passage;

[0010] A mobile valve leaf and a guide rod, both of which are located in the movable area, the outer periphery of the mobile valve leaf is circular and the top is convex, which is used to reduce blood flow resistance and reduce thrombus adhesion, the mobile valve leaf is installed on the guide rod and can reciprocate up and down along the track direction of the guide rod, so that the mobile valve leaf can open or close the whole passage of the through hole to relatively increase the opening area and have a small trans-valve pressure difference.

[0011] In a possible implementation, a sliding hole is provided in the middle of the mobile valve leaf, which is adapted to slide with the guide rod, the guide rod is inserted into the sliding hole, so that the mobile valve leaf reciprocates up and down along the track direction of the guide rod, which can reduce thrombus and valve clamping dysfunction.

[0012] In a possible implementation, the inner side of the mechanical valve ring is arc-shaped.

[0013] In a possible implementation, the limiting base is a ring-shaped hollow structure, the inner diameter of which is connected with a first supporting member for supporting the guide rod, and the bottom end of the guide rod is installed on the first supporting member.

[0014] In a possible implementation, the first supporting member comprises a first connecting part, an arch-shaped segment and a second connecting part connected in sequence.

[0015] The first end of the first connecting part is connected to one side of the open end of the arch-shaped segment, and the first end of the second connecting part is connected to the other side of the open end of the arch-shaped segment.

[0016] The second ends of the first connecting part and the second connecting part are respectively connected to the limiting base, and the bottom end of the guide rod is installed in the middle of the arch-shaped segment.

[0017] In a possible implementation, the mobile leaf is provided with an arc-shaped cavity, and the outer bending curvature of the arc-shaped section is equal to or smaller than the bending curvature of the arc-shaped cavity, for supporting the mobile leaf sliding along the guide rod.

[0018] In a possible implementation, the first support member is a horizontal rod, and the first end of the first support member is connected to the limiting base, and the second end is located in the middle of the limiting base and connected to the bottom end of the guide rod.

[0019] In a possible implementation, the top of the guide rod is higher than the mechanical valve ring, so that a movable allowance section is left in the direction of the moving track of the mobile leaf along the guide rod.

[0020] In a possible implementation, the inner diameter of the mechanical valve ring is connected with a second support member for installing the guide rod, and the top of the guide rod is installed to the middle of the second support member.

[0021] In a possible implementation, the second support member is an arc-shaped or elliptical structure.

[0022] In a possible implementation, at least one support leg is connected between the bottom of the mechanical valve ring and the top of the limiting base, so as to constitute an open movable area.

[0023] In a possible implementation, the outer diameter of the mobile leaf is greater than the inner diameter of the through hole and smaller than the inner diameter of the movable area surrounded by the support leg.

[0024] In a possible implementation, the top convex surface of the mobile leaf can extend to the outside of the mechanical valve ring.

[0025] In a possible implementation, the outer side of the mechanical valve ring is coaxially provided with an annular suture ring.

[0026] In summary, due to the adoption of the above technical solutions, the beneficial effects of the present application are:

[0027] In the application, the moving leaflet and the guide rod are used in cooperation, the moving leaflet can be used for reciprocating movement up and down, compared with the existing mechanical valve, the mechanical valve can effectively prevent thrombosis, is not easy to damage, and can be used for a long time; even if thrombosis is formed, it is not easy to be stuck, and the valve or dysfunction is avoided. Due to the fact that thrombosis is not easy to be formed, the patient does not need or only needs less anticoagulant therapy during use. There is no mechanical valve or biological valve blocking at the through hole, compared with the existing same type valve, the opening area of the mechanical valve is obviously larger than that of the existing mechanical valve and biological valve, a larger opening area and a smaller transvalvular pressure difference are provided, the performance of the valve is significantly improved, and the valve is suitable for more clinical patients, especially small valve rings or low weight patients. BRIEF DESCRIPTION OF DRAWINGS

[0028] Fig. 1 is a perspective view of the application;

[0029] Fig. 2 is a sectional view of the moving leaflet and the through hole in the closed state of the application;

[0030] Fig. 3 is a perspective view of the moving leaflet and the through hole in the open state of the application;

[0031] Fig. 4 is a sectional view of the moving leaflet and the through hole in the open state of the application;

[0032] Fig. 5 is a perspective view of the moving leaflet of the application;

[0033] Fig. 6 is a sectional view of the moving leaflet of the application;

[0034] Fig. 7 is a perspective view of another embodiment of the mechanical valve of the application;

[0035] Fig. 8 is a sectional view of another embodiment of the mechanical valve of the application.

[0036] Markings in the figure: 1, mechanical valve ring; 101, through hole; 2, limiting base; 201, active area; 3, moving leaflet; 301, sliding hole; 302, convex surface; 303, arched cavity; 4, guide rod; 400, active excess segment; 5, first support member; 501, first connecting part; 502, arched segment; 503, second connecting part; 6, second support member; 7, support leg; 8, annular suture ring. DETAILED DESCRIPTION

[0037] In order to make the purpose, technical scheme and advantages of the application more clear, the embodiments of the application will be further described in detail below with reference to the drawings.

[0038] Firstly, the overall structure of the single-leaf mechanical valve is described using Fig. 1, which is a perspective view of the application. The single-leaf mechanical valve is described below in the clinical situation.

[0039] Referring to Figs. 2-4, Fig. 2 is a cross-sectional view of the mobile leaflet 3 and the through hole 101 in a closed state, Fig. 3 is a perspective view of the mobile leaflet 3 and the through hole 101 in an open state, and Fig. 4 is a cross-sectional view of the mobile leaflet 3 and the through hole 101 in an open state.

[0040] The single-leaf mechanical valve comprises a mechanical valve ring 1, a limiting base 2, a mobile leaflet 3, and a guide rod 4, wherein:

[0041] Referring to Fig. 1, the mechanical valve ring 1 is generally circular or elliptical and is made of metal such as titanium alloy. When the mechanical valve is implanted in the human body, for example, implanted to replace the tricuspid valve or the mitral valve of the heart, the mechanical valve ring 1 is fixed at the native valve ring. The mechanical valve ring 1 has a through hole 101 in the middle for blood flow. The inner side of the mechanical valve ring 1 is arc-shaped, the edge is smooth, the blood flow resistance is small, the transvalvular pressure difference is small, and blood clots are not easy to adhere.

[0042] The limiting base 2 is located in the ventricle. The limiting base 2 is a ring-shaped hollow structure, and an open active area 201 is provided between the mechanical valve ring 1 and the limiting base 2. The limiting base 2 is installed at the bottom of the mechanical valve ring 1. As shown in Fig. 3, the top of the active area 201 is connected to the through hole 101 and forms a blood passage.

[0043] Referring to Figs. 1-4, the mobile leaflet 3 is installed on the guide rod 4. The mobile leaflet 3 and the guide rod 4 are located in the active area 201. The mobile leaflet 3 is installed on the guide rod 4 and can reciprocally move up and down along the track direction of the guide rod 4, so that the mobile leaflet 3 can actively open the entire passage of the through hole 101 (see Figs. 3 and 4) or actively close the entire passage of the through hole 101 (see Figs. 1 and 2), so as to relatively increase the opening area (the opening area of the same model valve is obviously larger than that of the existing mechanical valve and biological valve) and have a small transvalvular pressure difference, thereby significantly improving the performance of the valve and being suitable for more clinical patients, especially small valve rings or low-weight patients.

[0044] In this embodiment, when the mechanical valve is implanted in the human body, when the ventricle contracts, the mobile leaflet 3 moves along the guide rod 4 to the mechanical valve ring 1 to close the through hole 101 (see Figs. 1 and 2), which can achieve the effect of closing the mechanical valve ring 1, that is, block the blood passage and prevent blood flow through the mechanical valve ring 1 to the atrium;

[0045] When the atrium contracts, the mobile leaflet 3 moves away from the mechanical valve ring 1 along the guide rod 4, and there is no blocking object at the through hole 101 (see Figs. 3 and 4), the blood passage is open, and the blood flow can flow from the atrium to the ventricle in one direction, thereby realizing the one-way open function of the blood passage.

[0046] In the application, the mobile valve leaflet 3 can move up and down reciprocally under the cooperation of the mobile valve leaflet 3 and the guide rod 4. Compared with the existing mechanical valve, the mechanical valve in the application has no clamping groove and shaft device in structure, can effectively prevent thrombosis, and prolong the service life of the mechanical valve, is not easy to be damaged, and can be used for a long time. Even if thrombosis is formed, it is not easy to be stuck, and clamping or dysfunction is avoided. Moreover, since thrombosis is not easy to be formed, the patient does not need or only needs less anticoagulant therapy during use.

[0047] In addition, for some small valve rings or low-weight patients, due to the small valve ring, the current mechanical valve and biological valve cannot be normally implanted, and often need to be implanted by tilting the valve or expanding the valve ring, and at the same time, the trans-valve pressure difference is high, which affects the heart function of the patient and the service life of the valve.

[0048] In view of the above problems, referring to FIGS. 3 and 4, the mobile valve leaflet 3 in the above moves downward along the guide rod 4, the through hole 101 is opened, and there is no mechanical valve leaflet or biological valve blocking at the through hole 101 (i.e., the valve orifice). Compared with the existing same type valve, the opening area of the mechanical valve in the application is obviously larger than that of the existing mechanical valve and biological valve, and a larger opening area and smaller trans-valve pressure difference are provided. Therefore, for patients with a small valve ring, a smaller type valve can be selected for implantation than the currently applied valve, without the need to implant by tilting or expanding the valve ring, and a smaller trans-valve pressure difference can also be obtained.

[0049] Of course, the mechanical valve can also be implanted and replaced into the aortic valve or the pulmonary valve, so that the limiting base 2 is located in the aorta or the pulmonary artery, and plays a one-way guiding role along the direction of blood flow.

[0050] In some embodiments, as shown in FIG. 5, FIG. 5 is a perspective view of the mobile valve leaflet 3 in the application. The specific structure of the mobile valve leaflet 3 and the cooperation principle of the mobile valve leaflet 3 and the guide rod 4 are as follows:

[0051] The outer periphery of the mobile valve leaflet 3 is circular, and the top is convex 302, which can be used to reduce blood flow resistance and reduce thrombus adhesion;

[0052] The middle part of the mobile valve leaflet 3 is provided with a sliding hole 301, which is used for sliding with the guide rod 4. The guide rod 4 is inserted into the sliding hole 301, so that the mobile valve leaflet 3 slides up and down along the track direction of the guide rod 4.

[0053] In the present embodiment, as shown in FIG. 5, the mobile valve leaflet 3 is designed as follows: the outer periphery is circular, and the top is convex 302. This design makes the contact resistance of the mobile valve leaflet 3 to the blood flow small, the trans-valve pressure difference small, and the thrombus adhesion not easy. Moreover, the mobile valve leaflet 3 slides vertically along the central axis of the guide rod 4, is not easy to be damaged, has a long service life, and has no risk of thrombosis, clamping, dysfunction, etc. Therefore, the frequency of blood coagulation therapy can be reduced.

[0054] In addition, due to the mechanical properties of the valve, some patients can hear the "click" sound of the valve closing when the mechanical valve installed in the heart is opened and closed, which will give some people a bad feeling. In order to solve the problem of "click" sound, as shown in FIG. 1 and FIG. 2, the curved moving valve leaflet 3 is an integral whole, and the entire curved opening of the moving valve leaflet 3 is buckled on the mechanical valve ring 1 when the moving valve leaflet 3 changes from the open state to the closed state, which prevents the sound caused by the strong impact of a certain point or a certain area of the moving valve leaflet 3 on the mechanical valve ring. Due to the improved smooth closing performance, the noise of the moving valve leaflet 3 during operation is greatly reduced.

[0055] In some embodiments, as shown in FIG. 1. FIG. 1 is a perspective view of the present application. Regarding the specific installation structure of the guide rod 4. The inner diameter of the limiting base 2 is connected with the first support member 5 for supporting the guide rod 4, and the two sides of the first support member 5 have opening areas for blood circulation, so that the limiting base 2 forms a hollow structure.

[0056] The bottom end of the guide rod 4 is installed on the first support member 5, which serves to support and install the guide rod 4.

[0057] As shown in FIG. 2. FIG. 2 is a cross-sectional view of the moving valve leaflet 3 and the through hole 101 in the closed state. Regarding the specific structure and working principle of the first support member 5. The first support member 5 includes a first connecting part 501, an arch-shaped segment 502 and a second connecting part 503 connected in sequence;

[0058] The first end of the first connecting part 501 is connected to one side of the opening end of the arch-shaped segment 502, and the first end of the second connecting part 503 is connected to the other side of the opening end of the arch-shaped segment 502;

[0059] The second ends of the first connecting part 501 and the second connecting part 503 are respectively connected to the limiting base 2, so that the height of the arch-shaped segment 502 is higher than that of the limiting base 2, and the bottom end of the guide rod 4 is installed in the middle of the arch-shaped segment 502.

[0060] As shown in FIG. 6. FIG. 6 is a cross-sectional view of the moving valve leaflet 3 in the present application. In this embodiment, the moving valve leaflet 3 is provided with an arch-shaped cavity 303, and the bending radius of the outer part of the arch-shaped segment 502 is equal to or less than the bending radius of the arch-shaped cavity 303. In this embodiment, when the moving valve leaflet 3 moves downward along the trajectory direction of the guide rod 4, the arch-shaped cavity 303 provided in the moving valve leaflet 3 serves to support the moving valve leaflet 3 sliding downward along the guide rod 4, which can further avoid the valve from being stuck.

[0061] In some embodiments, as shown in FIG. 7. FIG. 7 is a perspective view of another embodiment of the mechanical valve in the present application. The structure of the mechanical valve in this embodiment is different from the above-mentioned embodiments in that the first support member 5 is a horizontal bar, the first end of the first support member 5 is connected to the limiting base 2, and the second end of the first support member 5 is located in the middle of the limiting base 2 and is connected to the bottom end of the guide rod 4, so that the first support member 5 is perpendicular to the guide rod 4, and the first support member 5 and the guide rod 4 as a whole support and guide the movement of the mobile valve leaflet 3.

[0062] In addition, as shown in FIG. 8. FIG. 8 is a cross-sectional view of another embodiment of the mechanical valve in the present application. The bottom of the mobile valve leaflet 3 in this embodiment is a solid surface structure. The bottom of the mobile valve leaflet 3 can also be provided with an arched cavity 303. The provision of the arched cavity 303 can facilitate the smooth movement of the blood flow to push the mobile valve leaflet 3 to block the through hole 101 during ventricular contraction, and can reduce material cost and the weight of the mobile valve leaflet 3.

[0063] In some embodiments, as shown in FIG. 1. FIG. 1 is a perspective view of the present application. Regarding the connection structure between the limiting base 2 and the mechanical valve ring 1, specifically, at least one support leg 7 is connected between the bottom of the mechanical valve ring 1 and the top of the limiting base 2. As shown in FIG. 1, the number of support legs 7 is two, and the two support legs 7 are symmetrically arranged between the mechanical valve ring 1 and the limiting base 2. Alternatively, as shown in FIG. 7, the number of support legs 7 is three, and the three support legs 7 are arranged in a ring matrix between the mechanical valve ring 1 and the limiting base 2. The space between the mechanical valve ring 1 and the limiting base 2 constitutes a movable area 201.

[0064] In addition, as shown in FIG. 1 or FIG. 7. The outer diameter of the mobile valve leaflet 3 is greater than the inner diameter of the through hole 101, and the outer diameter of the mobile valve leaflet 3 is less than the inner diameter of the movable area 201 surrounded by the support leg 7. This can enable the mobile valve leaflet 3 to move freely up and down in the movable area 201.

[0065] In some embodiments, as shown in FIG. 1. FIG. 1 is a perspective view of the present application. The inner diameter of the mechanical valve ring 1 is connected with a second support member 6 for mounting the guide rod 4, and the second support member 6 is in an arc or elliptical shape.

[0066] The top of the guide rod 4 is mounted to the middle of the second support member 6. The top of the guide rod 4 is higher than the mechanical valve ring 1, so that there is a movement allowance segment 400 in the direction of the movement track of the mobile valve leaflet 3 along the guide rod 4. When the mobile valve leaflet 3 moves upward along the guide rod 4 to close the through hole 101, the top convex surface 302 of the mobile valve leaflet 3 at this time can extend to the outside of the mechanical valve ring 1.

[0067] In the present embodiment, the mechanical valve is a hollow structure, the guide rod 4 is fixed between the first support member 5 and the second support member 6, and part of the mechanical valve is out of the atrium, the total volume is small, and the blood volume in the atrium, ventricle or blood vessel is not affected.

[0068] In some embodiments, as shown in Figure 1. Figure 1 is a schematic diagram of the present application. In order to facilitate the connection and fixation of the mechanical valve ring 1 with the autologous valve ring, an annular suture ring 8 is coaxially arranged on the outer side of the mechanical valve ring 1. The mechanical valve 1 and the autologous valve can be conveniently sutured and fixed through the annular suture ring 8. The annular suture ring 8 is a common structure.

[0069] In the description of the present application, it should be noted that the terms "comprise", "contain" or any other variants thereof are intended to cover non-exclusive inclusion, so that the process, method, article or device including a series of elements not only includes those elements, but also includes other elements not explicitly listed or inherent to such process, method, article or device. Without more limitation, the element defined by the sentence "comprises a" does not exclude the presence of other identical elements in the process, method, article or device including the element.

[0070] In addition, in the description of the present application, the terms "upper", "lower", "front", "rear", "left", "right", "top", "bottom", "inner", "outer" and the like indicate 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 do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application.

[0071] On the other hand, it should be noted that unless otherwise explicitly specified and limited, the terms "provided", "mounted", "connected", "linked" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or integrally connected; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium, or it can be the communication between two elements inside. As used herein, references to "members", "components" or "parts" shall not be limited to a single structural member, component or element, but can include a combination of components, members or elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood in specific circumstances.

Claims

1. A monoleaflet mechanical valve, characterized in that, The utility model relates to a mechanical valve ring, a limit base is installed to the bottom of the mechanical valve ring, and an open activity area is arranged between the mechanical valve ring and the limit base, the top of the activity area is communicated to the through hole and makes it constitute a blood passage, a moving valve leaf and a guide rod are located in the activity area, the outer periphery of the moving valve leaf is circular, and the top is convex, the moving valve leaf is installed to the guide rod and can reciprocate up and down along the track direction of the guide rod, so that the moving valve leaf can open or close the whole passage of the through hole. The middle part of the moving valve leaf is provided with a sliding hole matched with the sliding of the guide rod, and the guide rod is inserted into the sliding hole, so that the moving valve leaf reciprocates up and down along the track direction of the guide rod. The limit base is a ring hollow structure, and a first supporting member for supporting the guide rod is connected between the inner diameter of the limit base, and the bottom end of the guide rod is installed to the first supporting member. The first supporting member comprises a first connecting part, an arch-shaped section and a second connecting part connected in sequence.

2. The monoleaflet mechanical valve of claim 1, wherein, The first end of the first connecting part is connected to one side of the open end of the arch-shaped section, and the first end of the second connecting part is connected to the other side of the open end of the arch-shaped section.

3. The monoleaflet mechanical valve according to claim 1 or 2, characterized in that The second ends of the first connecting part and the second connecting part are connected to the limit base respectively, and the bottom end of the guide rod is installed to the middle part of the arch-shaped section.

4. The monoleaflet mechanical valve of claim 3, wherein, The moving valve leaf is provided with an arch-shaped cavity, and the bending curvature of the outer part of the arch-shaped section is equal to or smaller than the bending curvature of the arch-shaped cavity, so as to support the moving valve leaf sliding down along the guide rod. The first supporting member is a horizontal rod, the first end of the first supporting member is connected to the limit base, and the second end of the first supporting member is located in the middle part of the limit base and connected to the bottom end of the guide rod. The inner diameter of the mechanical valve ring is connected with a second supporting member for installing the guide rod, and the top of the guide rod is installed to the middle part of the second supporting member.

5. The monoleaflet mechanical valve of claim 4, wherein, The top of the guide rod is higher than the mechanical valve ring, so that the moving valve leaf has a movable residual section along the moving track direction of the guide rod.

6. The monoleaflet mechanical valve of claim 3, wherein, The bottom of the mechanical valve ring is connected with at least one supporting leg between the top of the limit base, so as to constitute the open activity area.

7. The monoleaflet mechanical valve of claim 4, wherein, The outer diameter of the moving valve leaf is greater than the inner diameter of the through hole and smaller than the inner diameter of the activity area surrounded by the supporting leg.

8. The monoleaflet mechanical valve of claim 7, wherein, The convex top of the moving valve leaf can extend to the outside of the mechanical valve ring.

9. The monoleaflet mechanical valve of claim 7, wherein, The outer side of the mechanical valve ring is coaxially provided with a ring suture ring. ​ 10. The monoleaflet mechanical valve of claim 1, wherein, ​ 11. The monoleaflet mechanical valve of claim 1, wherein, ​

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