Single-leaf mechanical valve

Abstract

The invention discloses a single-leaf mechanical valve which comprises a mechanical valve ring, a limiting base, a movable valve leaf and a guide rod. A via hole is formed in the middle of the mechanical valve ring; the limiting base is installed at the bottom of the mechanical valve ring, and an open moving area is arranged between the mechanical valve ring and the limiting base; the movable valve leaflet and the guide rod are both located in the movable area, and the movable valve leaflet can move up and down in a reciprocating mode in the track direction of the guide rod, so that the movable valve leaflet can movably open or close the whole channel opening of the through hole, the opening area is relatively increased, and the valve crossing pressure difference is small; through cooperation of the movable valve leaflet and the guide rod, thrombus formation is effectively avoided, and damage is not prone to occurring; even if thrombus is formed, the valve is not prone to being clamped, the risk of valve clamping or dysfunction is avoided, and anticoagulation treatment can be reduced or not needed. According to the mechanical valve, a larger opening area is provided, the performance of the valve is remarkably improved, and the mechanical valve is suitable for more clinical patients, especially small-valve-ring or low-weight patients.

Description

Technical Field

[0001] The present invention relates to the technical field of mechanical valves, and in particular to a single-leaflet mechanical valve. Background Art

[0002] Patients with heart disease, especially those with mitral valve, aortic valve, tricuspid valve and pulmonary valve lesions, are often accompanied by congenital malformations of the valve or later acquired stenosis, insufficiency and other problems, which in turn lead to heart failure and congestion in the systemic or pulmonary circulation. Clinically, such patients show symptoms such as shortness of breath, palpitations, fatigue, abdominal distension, and lower limb edema after activity. If not treated promptly, the condition may deteriorate rapidly and even develop into heart failure. Patients can only choose artificial heart implantation or wait for heart transplantation. Currently, the main treatments for valvular disease include valve repair and valve replacement surgery.

[0003] In valve replacement, the artificial valves commonly used in clinical practice are divided into two categories: mechanical valves and biological valves. For patients without atrial fibrillation, anticoagulation treatment is usually for half a year after biological valve replacement. However, the service life of biological valves is limited, generally 3 to 15 years, and with the increase in usage time, there is a risk of decay and damage, which is particularly unsuitable for young patients. Mechanical valves have become a common choice due to their long-term durability, but they require lifelong anticoagulation treatment. Whether it is a single-leaf, bi-leaf or tri-leaf mechanical valve, there is a risk of organ bleeding during anticoagulation treatment, such as cerebral hemorrhage, gastrointestinal bleeding, excessive growth of vascular pannus, loss of valve orifice area, and even dysfunction, requiring re-surgery. At the same time, insufficient anticoagulation may lead to thrombosis, resulting in valve dysfunction or embolism, further increasing the risk of complications such as valve jamming and cerebral infarction. For some patients with small valve rings or low body weight, due to the small size of the valve ring, the existing mechanical valves and biological valves cannot meet the implantation requirements. Such patients usually need to enlarge the valve ring or choose an oversized valve for implantation, which not only increases the difficulty of surgery, but also leads to a significant increase in transvalvular pressure gradient, affecting the patient's heart function and possibly shortening the life of the valve. Especially in patients with small valve rings, oversized valves increase the risk of valve dysfunction, which in turn affects the treatment effect.

[0004] Therefore, existing mechanical valves and biological valves still have many problems when used in patients with small valve rings or low body weight, and a new valve that can solve these limitations is urgently needed. Summary of the invention

[0005] The purpose of the present invention is to provide a single-leaflet mechanical valve to solve the above-mentioned problems, specifically a mechanical valve that can be used for a long time, avoids valve sticking or dysfunction, and requires no or only low anticoagulant treatment, and has a larger valve orifice area (the opening area of ​​the valve of the same model is significantly larger than that of existing mechanical valves and biological valves).

[0006] In order to achieve the above object, the technical solution adopted by the present invention is as follows: The present application provides a single-leaflet mechanical valve, comprising: A mechanical valve ring with a conducting hole in the middle; A limiting base is installed on the bottom of the mechanical valve ring, an open movable area is provided between the mechanical valve ring and the limiting base, and the top of the movable area is connected to the conducting hole to form a blood channel; The movable leaflet and the guide rod are both located within the active area. The outer periphery of the movable leaflet is circular and the top is convex, which is used to reduce blood flow resistance and reduce thrombus adhesion. The movable leaflet is installed on the guide rod and can move back and forth up and down along the trajectory direction of the guide rod, so that the movable leaflet can movably open or close the entire channel opening of the conducting hole to achieve a relatively increased opening area and a small transvalvular pressure difference.

[0007] In a possible embodiment, a sliding hole adapted to slide with the guide rod is opened in the middle of the movable leaflet, and the guide rod is inserted into the sliding hole so that the movable leaflet can slide back and forth up and down along the trajectory of the guide rod, thereby reducing thrombosis and stuck valve dysfunction.

[0008] In a possible implementation, the inner side of the mechanical valve ring is arc-shaped.

[0009] In a possible implementation, the limiting base is an annular hollow structure, and a first supporting member for supporting the guide rod is connected between the inner diameter of the limiting base, and the bottom end of the guide rod is mounted on the first supporting member.

[0010] In a possible implementation, the first supporting member includes a first connecting component, an arched segment, and a second connecting component that are sequentially connected; The first end of the first connecting member is connected to one side of the open end of the arched segment, and the first end of the second connecting member is connected to the other side of the open end of the arched segment; The second ends of the first connecting member and the second connecting member are respectively connected to the limiting base, and the bottom end of the guide rod is installed to the middle part of the arched section.

[0011] In a possible implementation, an arched cavity is provided in the movable leaflet, and the outer curvature of the arched segment is equal to or smaller than the curvature of the arched cavity, so as to support the movable leaflet sliding down along the guide rod.

[0012] In a possible implementation, the first supporting member is a cross bar, a first end of the first supporting member is connected to the limiting base, and a second end of the first supporting member is located in the middle of the limiting base and connected to the bottom end of the guide rod.

[0013] In a possible implementation, the top of the guide rod is higher than the mechanical valve ring, so that the movable leaflet has a movable margin section along the moving trajectory of the guide rod.

[0014] In a possible implementation, a second support member for mounting the guide rod is connected between the inner diameter of the mechanical valve ring, and the top of the guide rod is mounted to the middle of the second support member.

[0015] In a possible implementation, the second supporting member is an arc-shaped or elliptical structure.

[0016] In a possible implementation, at least one supporting leg is connected between the bottom of the mechanical valve ring and the top of the limiting base, so as to form the open activity area.

[0017] In a possible implementation, the outer diameter of the movable leaflet is larger than the inner diameter of the conducting hole, and smaller than the inner diameter of the active area surrounded by the supporting legs.

[0018] In a possible embodiment, the top convex surface of the movable leaflet may extend to the outside of the mechanical valve ring.

[0019] In a possible implementation, an annular suture ring is coaxially provided on the outer side of the mechanical valve ring.

[0020] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are: In the present invention, by using the movable leaflet in conjunction with the guide rod, the movable leaflet can be used to move up and down reciprocatingly. Compared with the existing mechanical valve, it can effectively prevent thrombosis, is not easy to be damaged, and can be used for a long time; even if a thrombus is formed, it is not easy to get stuck, thus avoiding valve jamming or functional disorders. Since it is not easy to produce thrombus, patients do not need or only need less anticoagulant treatment during use. There is no obstruction of mechanical leaflets or biological valves at the conduction hole. Compared with the existing valves of the same model, the opening area of ​​the mechanical valve is significantly larger than the existing mechanical valves and biological valves, providing a larger opening area and a small transvalvular pressure difference, which significantly improves the performance of the valve and is suitable for more clinical patients, especially those with small valve rings or low body weight. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a three-dimensional schematic diagram of the present invention; Figure 2 It is a cross-sectional view of the movable leaflet and the conducting hole in the present invention in a closed state; Figure 3 It is a stereoscopic diagram of the movable leaflet and the conducting hole in the present invention in an open state; Figure 4 It is a cross-sectional view of the movable leaflet and the conducting hole in the present invention when they are in an open state; Figure 5 is a three-dimensional schematic diagram of the movable leaflet in the present invention; Figure 6 is a cross-sectional view of the movable leaflet in the present invention; Figure 7 is a three-dimensional diagram of another embodiment of the mechanical valve of the present invention; Figure 8 It is a cross-sectional view of another embodiment of the mechanical valve in the present invention.

[0022] Markings in the figure: 1. Mechanical valve ring; 101. Conducting hole; 2. Limit base; 201. Activity area; 3. movable leaflet; 301. sliding hole; 302. convex surface; 303. arched cavity; 4. Guide rod; 400, movable margin section; 5. first supporting member; 501. first connecting member; 502. arched segment; 503. second connecting member; 6. A second supporting member; 7. Support leg; 8. Annular suture ring. DETAILED DESCRIPTION

[0023] In order to make the objectives, technical solutions and advantages of the present application clearer, the implementation methods of the present application will be further described in detail below in conjunction with the accompanying drawings.

[0024] First, use Figure 1 , the overall structure of the single-leaflet mechanical valve is described. Figure 1 The following is a three-dimensional schematic diagram of the present invention. The single-leaflet mechanical valve is described in the following under the condition of clinical application.

[0025] Reference Figure 2-Figure 4 , Figure 2 It is a cross-sectional view of the movable leaflet 3 and the conducting hole 101 in the closed state in the present invention. Figure 3 It is a stereoscopic diagram of the movable leaflet 3 and the conducting hole 101 in the present invention in an open state. Figure 4 It is a cross-sectional view of the movable leaflet 3 and the conducting hole 101 in the open state in the present invention.

[0026] The single-leaflet mechanical valve comprises a mechanical valve ring 1, a limiting base 2, a movable valve leaf 3 and a guide rod 4, wherein: Reference Figure 1 The mechanical valve ring 1 is usually circular or elliptical and made of metal such as titanium alloy. When the mechanical valve is implanted in the human body, for example, when it is implanted and replaced in the tricuspid valve or mitral valve of the heart, the mechanical valve ring 1 is fixed to the native valve ring. The middle of the mechanical valve ring 1 has a conducting hole 101 for blood circulation. The inner side of the mechanical valve ring 1 is arc-shaped with smooth edges, small blood flow resistance, small transvalvular pressure difference, and not easy to attach thrombus.

[0027] The limiting base 2 is located in the ventricle. The limiting base 2 is a ring-shaped hollow structure, and an open activity area 201 is provided between the mechanical valve ring 1 and the limiting base 2. The limiting base 2 is installed to the bottom of the mechanical valve ring 1. Figure 3 As shown, the top of the active area 201 is connected to the conducting hole 101 and forms a blood channel.

[0028] Reference Figure 1-Figure 4 As shown, the movable leaflet 3 is mounted on the guide rod 4. The movable leaflet 3 and the guide rod 4 are both located in the active area 201. The movable leaflet 3 is mounted on the guide rod 4 and can reciprocate up and down along the track direction of the guide rod 4, so that the movable leaflet 3 can move to open the entire channel opening of the guide hole 101 (refer to Figure 3 and Figure 4 ), or the movable leaflet 3 can movably close the entire channel opening of the conducting hole 101 (refer to Figure 1 and Figure 2 ) to achieve a relatively larger opening area (the opening area of ​​the same type of valve is significantly larger than the existing mechanical valves and biological valves) and a small transvalvular pressure difference, which significantly improves the performance of the valve and is suitable for more clinical patients, especially those with small valve rings or low body weight.

[0029] In this embodiment, when the mechanical valve is implanted in a human body, when the ventricle contracts, the movable leaflet 3 moves along the guide rod 4 to the mechanical valve ring 1 to close the conducting hole 101 (see Figure 1 and Figure 2 ), which can achieve the effect of closing the mechanical valve ring 1, that is, blocking the blood channel and preventing blood from flowing through the mechanical valve ring 1 to the atrium; When the atrium contracts, the movable leaflet 3 moves away from the mechanical valve ring 1 along the guide rod 4, and there is no obstruction at the conducting hole 101 (see Figure 3 and Figure 4 ), the blood channel is open, and blood can flow unidirectionally from the atrium to the ventricle, realizing the unidirectional conduction function of the blood channel.

[0030] In the present invention, the movable leaflet 3 can be used for reciprocating up and down movement by cooperating with the guide rod 4. Compared with the existing mechanical valve, the structure has no slots and shafts, which can effectively prevent thrombosis and extend the service life of the mechanical valve. It is not easy to be damaged and can be used for a long time. Even if thrombosis is formed, it is not easy to get stuck, thus avoiding valve jam or functional disorder. In addition, since thrombosis is not easy to occur, patients do not need or only need less anticoagulation treatment during use.

[0031] In addition, for some patients with small valve annuli or low body weight, the current mechanical valves and biological valves cannot be implanted normally due to the small valve annulus. Implantation often requires methods such as tilting the valve or expanding the valve annulus. At the same time, the transvalvular pressure gradient is high, affecting the patient's cardiac function and the life of the valve.

[0032] For the above problems, see Figure 3 and Figure 4 When the movable leaflet 3 mentioned above moves downward along the guide rod 4 and the conducting hole 101 is opened, there is no obstruction of the mechanical leaflet or the biological valve at the conducting hole 101 (i.e., the valve orifice). Compared with the existing valves of the same type, the opening area of ​​the mechanical valve in the present invention is significantly larger than the existing mechanical valves and biological valves, providing a larger opening area and a smaller transvalvular pressure difference. Therefore, for patients with a small valve ring, a smaller valve model than the currently used valve can be selected for implantation without the need to adopt methods such as tilting or expanding the valve ring for implantation, and a smaller transvalvular pressure difference can also be obtained.

[0033] Of course, the mechanical valve can also be implanted and replaced in 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 unidirectional conduction role along the direction of blood flow.

[0034] In some embodiments, Figure 5 shown. Figure 5 Schematic diagram of the movable leaflet 3 in the present invention. The specific structure of the movable leaflet 3 and the matching principle of the movable leaflet 3 and the guide rod 4 are as follows: The outer periphery of the movable leaflet 3 is circular and the top is convex 302, which can be used to reduce blood flow resistance and reduce thrombus adhesion; A sliding hole 301 is provided in the middle of the movable leaflet 3 , and the sliding hole 301 is used to slide with the guide rod 4 . The guide rod 4 is inserted into the sliding hole 301 , so that the movable leaflet 3 slides back and forth up and down along the track direction of the guide rod 4 .

[0035] In this embodiment, if Figure 5As shown, the movable leaflet 3 is designed to have a circular outer periphery and a convex top 302. This design reduces the resistance to blood flow, reduces the pressure difference across the leaflet, and makes it less likely for thrombus to adhere. The movable leaflet 3 slides vertically along the central axis of the guide rod 4, is not easily damaged, has a long service life, and has no risks of thrombus, stuck leaflet, functional disorder, etc.; therefore, the frequency of coagulation therapy can be reduced.

[0036] In addition, due to the mechanical properties of the valve, some patients can hear the valve "click" when the mechanical valve installed in the heart opens and closes, which will give some people a bad feeling. Figure 1 and Figure 2 As shown, the curved movable leaflet 3 is a whole. When the movable leaflet 3 changes from an open state to a closed state, the entire curved opening of the movable leaflet 3 will be buckled on the mechanical valve ring 1. This prevents a certain point or area of ​​the movable leaflet 3 from strongly impacting the mechanical valve ring and generating sound. Since the performance of smooth closing is improved, the noise during the operation of the movable leaflet 3 is greatly reduced.

[0037] In some embodiments, Figure 1 shown. Figure 1 It is a three-dimensional schematic diagram of the present invention. Regarding the specific installation structure of the guide rod 4. A first support member 5 for supporting the guide rod 4 is connected between the inner diameter of the limit base 2, and both sides of the first support member 5 are provided with opening areas for blood circulation, so that the limit base 2 forms a hollow structure.

[0038] The bottom end of the guide rod 4 is mounted on the first supporting member 5 , which is used to support and mount the guide rod 4 .

[0039] like Figure 2 shown. Figure 2 It is a cross-sectional view of the movable leaflet 3 and the conducting hole 101 in the present invention in a closed state. Regarding the specific structure and working principle of the first supporting member 5. The first supporting member 5 includes a first connecting member 501, an arched segment 502 and a second connecting member 503 connected in sequence; A first end of the first connecting member 501 is connected to one side of the opening end of the arched section 502, and a first end of the second connecting member 503 is connected to the other side of the opening end of the arched section 502; The second ends of the first connecting member 501 and the second connecting member 503 are respectively connected to the limiting base 2 so that the arched section 502 thereof is higher than the limiting base 2 , and the bottom end of the guide rod 4 is installed to the middle of the arched section 502 .

[0040] like Figure 6 shown. Figure 6: is a cross-sectional view of the movable flap 3 in the present invention. The movable flap 3 in this embodiment is provided with an arched cavity 303, and the curvature of the outer curvature of the arched segment 502 is equal to or less than the curvature of the arched cavity 303. In this embodiment, when the movable flap 3 moves downward along the trajectory direction of the guide rod 4, the movable flap 3 is provided with an arched cavity 303, which is used to support the movable flap 3 sliding down along the guide rod 4, and can further avoid flap jamming.

[0041] In some embodiments, Figure 7 shown. Figure 7 : is a stereoscopic diagram of another embodiment of the mechanical valve of the present invention. The structure of the mechanical valve is different from that of the above embodiment in that the first support member 5 is a cross bar, the first end of the first support member 5 is connected to the limiting base 2, the second end of the first support member 5 is located in the middle of the limiting base 2 and connected to the bottom end of the guide rod 4, so that the first support member 5 and the guide rod 4 are vertically arranged, and the first support member 5 and the guide rod 4 as a whole play a supporting and guiding role for the movable leaflet 3.

[0042] In addition, if Figure 8 shown. Figure 8 2 is a cross-sectional view of another embodiment of the mechanical valve of the present invention. The bottom of the movable leaflet 3 in this embodiment is a solid surface structure, and an arched cavity 303 can also be provided at the bottom of the movable leaflet 3. The provision of the arched cavity 303 can facilitate blood flow to smoothly push the movable leaflet 3 to block the conducting hole 101 when the ventricle contracts, and can reduce materials, reduce costs, and reduce the weight of the movable leaflet 3.

[0043] In some embodiments, Figure 1 shown. Figure 1 The connection structure between the limiting base 2 and the mechanical valve ring 1 is as follows: at least one supporting leg 7 is connected between the bottom of the mechanical valve ring 1 and the top of the limiting base 2. Figure 1 As shown, there are two supporting legs 7, and the two supporting legs 7 are symmetrically arranged between the mechanical valve ring 1 and the limiting base 2, or in other words, Figure 7 As shown, there are three supporting legs 7, which 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 an active area 201.

[0044] In addition, if Figure 1 or Figure 7 The outer diameter of the movable leaflet 3 is larger than the inner diameter of the conducting hole 101 , and the outer diameter of the movable leaflet 3 is smaller than the inner diameter of the active area 201 surrounded by the supporting legs 7 . The movable leaflet 3 can freely move up and down in the active area 201 .

[0045] In some embodiments, Figure 1shown. Figure 1 The second support member 6 for mounting the guide rod 4 is connected between the inner diameter of the mechanical valve ring 1, and the second support member 6 is an arc-shaped or elliptical structure.

[0046] 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 the movable leaflet 3 has a movable margin section 400 along the moving track direction of the guide rod 4. When the movable leaflet 3 moves up along the guide rod 4 and closes the conducting hole 101, the top convex surface 302 of the movable leaflet 3 can extend to the outside of the mechanical valve ring 1.

[0047] In this 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 protruding from the atrium. The total volume is small and does not affect the blood volume in the atrium, ventricle or blood vessels.

[0048] In some embodiments, Figure 1 shown. Figure 1 It is a three-dimensional schematic diagram of the present invention. In order to facilitate the connection and fixation between the mechanical valve ring 1 and the autologous valve ring, an annular sewing ring 8 is coaxially provided on the outer side of the mechanical valve ring 1. The mechanical valve ring 1 and the autologous valve can be conveniently sutured and fixed by the annular sewing ring 8. The structure of the annular sewing ring 8 is a common structure.

[0049] In the description of the present invention, it should be noted that the terms "comprises", "includes" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also includes other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "comprises a ..." does not exclude the existence of other identical elements in the process, method, article or device including the element.

[0050] In addition, in the description of the present invention, the terms "upper", "lower", "front", "back", "left", "right", "top", "bottom", "inside", "outside", etc. indicate directions or positional relationships based on the directions or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction. Therefore, they should not be understood as limitations on the present invention.

[0051] On the other hand, it should be noted that, unless otherwise clearly specified and limited, the terms "provided on", "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, or it can be internal communication between two elements. As described herein, references to "component", "part" or "portion" should not be limited to a single structural member, part or element, but may include an assembly of parts, components or elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

Claims

1. A single-leaflet mechanical valve, characterized in that: include: A mechanical valve ring with a conducting hole in the middle; A limiting base is installed on the bottom of the mechanical valve ring, an open movable area is provided between the mechanical valve ring and the limiting base, and the top of the movable area is connected to the conducting hole to form a blood channel; The movable leaflet and the guide rod are both located in the active area. The outer periphery of the movable leaflet is circular and the top is convex. The movable leaflet is mounted on the guide rod and can move back and forth up and down along the trajectory direction of the guide rod, so that the movable leaflet can movably open or close the entire channel opening of the guide hole.

2. The single-leaflet mechanical valve according to claim 1, characterized in that: A sliding hole adapted to slide with the guide rod is opened in the middle of the movable leaflet, and the guide rod is inserted into the sliding hole to make the movable leaflet slide reciprocatingly up and down along the track direction of the guide rod.

3. The single-leaflet mechanical valve according to claim 1 or 2, characterized in that: The limiting base is an annular hollow structure, and a first supporting member for supporting the guide rod is connected between the inner diameter of the limiting base, and the bottom end of the guide rod is mounted on the first supporting member.

4. The single-leaflet mechanical valve according to claim 3, characterized in that: The first supporting member comprises a first connecting part, an arched segment and a second connecting part connected in sequence; The first end of the first connecting member is connected to one side of the open end of the arched segment, and the first end of the second connecting member is connected to the other side of the open end of the arched segment; The second ends of the first connecting member and the second connecting member are respectively connected to the limiting base, and the bottom end of the guide rod is installed to the middle part of the arched section.

5. The single-leaflet mechanical valve according to claim 4, characterized in that: An arched cavity is provided in the movable leaflet, and the outer curvature of the arched segment is equal to or smaller than the curvature of the arched cavity, so as to support the movable leaflet sliding down along the guide rod.

6. The single-leaflet mechanical valve according to claim 3, characterized in that: The first supporting member is a cross bar, a first end of the first supporting member is connected to the limiting base, and a second end of the first supporting member is located in the middle of the limiting base and connected to the bottom end of the guide rod.

7. The single-leaflet mechanical valve according to claim 4, characterized in that: A second supporting member for mounting the guide rod is connected between the inner diameters of the mechanical valve ring, and the top of the guide rod is mounted to the middle of the second supporting member.

8. The single-leaflet mechanical valve according to claim 7, characterized in that: The top of the guide rod is higher than the mechanical valve ring, so that the movable leaflet has a movable margin section along the moving track direction of the guide rod.

9. The single-leaflet mechanical valve according to claim 7, characterized in that: At least one supporting leg is connected between the bottom of the mechanical valve ring and the top of the limiting base, so as to form the open activity area; The outer diameter of the movable leaflet is larger than the inner diameter of the conducting hole, and smaller than the inner diameter of the active area surrounded by the supporting legs.

10. The single-leaflet mechanical valve according to claim 1, characterized in that: The top convex surface of the movable leaflet may extend to the outside of the mechanical valve ring.

11. The single-leaflet mechanical valve according to claim 1, characterized in that: An annular sewing ring is coaxially arranged on the outer side of the mechanical valve ring.

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