A single-leaf mechanical valve

Abstract

The present invention discloses a single-leaflet mechanical valve, comprising a mechanical valve ring, a limiting base, a movable leaflet and a guide rod; a conducting hole is provided in the middle of the mechanical valve ring; the limiting base is mounted to the bottom of the mechanical valve ring, and an open movable area is provided between the mechanical valve ring and the limiting base; the movable leaflet and the guide rod are both located in the movable area, and the movable leaflet can move back and forth up and down along the trajectory direction of the guide rod, so that the movable leaflet can move to open or close the entire channel opening of the conducting hole, so as to achieve a relatively increased opening area and a small transvalvular pressure difference; the present invention effectively avoids thrombosis through the cooperation of the movable leaflet and the guide rod, and is not easy to be damaged; even if thrombosis is formed, it is not easy to cause the valve to get stuck, thus avoiding the risk of valve sticking or dysfunction, and can reduce or eliminate the need for anticoagulation treatment; the mechanical valve provides a larger opening area, significantly improves the performance of the valve, and is suitable for more clinical patients, especially patients with small valve rings or low body weight.

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 lesions of the mitral valve, aortic valve, tricuspid valve and pulmonary valve, 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 in time, 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 prosthetic valves commonly used clinically are divided into two categories: mechanical valves and bioprosthetic valves. For patients without atrial fibrillation, anticoagulation therapy is typically continued for six months after bioprosthetic valve replacement. However, bioprosthetic valves have a limited lifespan, generally ranging from three to 15 years, and are at risk of degradation and damage with age, making them particularly unsuitable for younger patients. Mechanical valves, on the other hand, are a common choice due to their long-term durability, but they require lifelong anticoagulation therapy. Whether using a single-leaflet, bileaflet, or trileaflet mechanical valve, anticoagulation therapy carries the risk of organ bleeding, such as cerebral and gastrointestinal bleeding, pannus overgrowth, loss of valve orifice area, and even functional impairment, necessitating reoperation. Furthermore, inadequate anticoagulation can lead to thrombosis, resulting in valve dysfunction or embolism, further increasing the risk of complications such as valve seizure and cerebral infarction. For some patients with small annulus or low body weight, existing mechanical and bioprosthetic valves are insufficient for implantation due to the smaller annulus size. These patients often require an enlarged annulus or an oversized valve for implantation, which not only increases surgical difficulty but also significantly increases transvalvular pressure gradients, impacting cardiac function and potentially shortening the lifespan of the valve. Especially in patients with small annular valves, oversized valves increase the risk of valve dysfunction, further compromising treatment outcomes.

[0004] Therefore, existing mechanical valves and biological valves still have many problems when used in patients with small valve annuli or low body weight, and there is an urgent need for a new valve that can solve these limitations. 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 jamming or functional disorders, 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:

[0007] The present application provides a single-leaflet mechanical valve, comprising:

[0008] A mechanical valve ring with a conducting hole in the middle;

[0009] A limiting base is mounted 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;

[0010] 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 guide hole, so as to achieve a relatively increased opening area and a small trans-valvular pressure difference.

[0011] 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 slides back and forth up and down along the trajectory of the guide rod, thereby reducing thrombosis and stuck valve dysfunction.

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

[0013] In a possible embodiment, the limiting base is an annular hollow structure, and a first supporting member for supporting the guide rod is connected between the inner diameter thereof, and the bottom end of the guide rod is mounted on the first supporting member.

[0014] In a possible embodiment, the first supporting member includes a first connecting component, an arched segment, and a second connecting component connected in sequence;

[0015] 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;

[0016] 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 of the arch section.

[0017] In a possible embodiment, 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, for supporting the movable leaflet sliding down the guide rod.

[0018] In a possible embodiment, 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 is located in the middle of the limiting base and connected to the bottom end of the guide rod.

[0019] In a possible embodiment, 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.

[0020] In a possible embodiment, a second support 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 support member.

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

[0022] In a possible embodiment, 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 active area.

[0023] 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.

[0024] In one possible embodiment, the top convex surface of the mobile leaflet may extend to the outside of the mechanical valve ring.

[0025] In one possible embodiment, an annular sewing ring is coaxially provided on the outer side of the mechanical valve ring.

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

[0027] In the present invention, by using the movable leaflet in conjunction with the guide rod, the movable leaflet can be moved up and down for use. 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 thrombosis, patients do not need or only need less anticoagulant treatment during use. There is no obstruction of mechanical leaflets or biological valves at the guide 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

[0028] Figure 1 It is a three-dimensional schematic diagram of the present invention;

[0029] Figure 2 A cross-sectional view of the movable leaflet and the conducting hole in the present invention in a closed state;

[0030] Figure 3 A three-dimensional diagram of the movable leaflet and the conducting hole in the present invention in an open state;

[0031] Figure 4 A cross-sectional view of the movable leaflet and the conducting hole in the present invention in an open state;

[0032] Figure 5 is a three-dimensional schematic diagram of the movable leaflet in the present invention;

[0033] Figure 6 is a cross-sectional view of the movable leaflet of the present invention;

[0034] Figure 7 is a perspective view of another embodiment of the mechanical valve of the present invention;

[0035] Figure 8 It is a cross-sectional view of another embodiment of the mechanical valve of the present invention.

[0036] Markings in the figure:

[0037] 1. Mechanical valve ring; 101. Conductive hole;

[0038] 2. Limit base; 201. Activity area;

[0039] 3. Moving leaflet; 301. Sliding hole; 302. Convex surface; 303. Arched cavity;

[0040] 4. Guide rod; 400, movable margin section;

[0041] 5. First supporting member; 501. First connecting member; 502. Arched segment; 503. Second connecting member;

[0042] 6. a second supporting member;

[0043] 7. Support leg;

[0044] 8. Annular suture ring. DETAILED DESCRIPTION

[0045] In order to make the objectives, technical solutions and advantages of this application clearer, the implementation methods of this application will be further described in detail below with reference to the accompanying drawings.

[0046] First, use Figure 1 , the overall structure of this single-leaflet mechanical valve is explained, Figure 1 The following is a 3D schematic diagram of the present invention. The single-leaflet mechanical valve is described below under the conditions of clinical application.

[0047] 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 open state in the present invention. 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.

[0048] The single-leaflet mechanical valve comprises a mechanical valve ring 1, a limiting base 2, a movable leaflet 3 and a guide rod 4, wherein:

[0049] 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 in the tricuspid valve or mitral valve of the heart, the mechanical valve ring 1 is fixed to the native valve ring. The mechanical valve ring 1 has a conductive hole 101 in the middle for blood circulation. The inner side of the mechanical valve ring 1 is curved with smooth edges, which reduces blood flow resistance, reduces transvalvular pressure difference, and is not easy to cause thrombus adhesion.

[0050] 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.

[0051] Reference Figure 1-Figure 4 As shown, the movable leaflet 3 is mounted on the guide rod 4. Both the movable leaflet 3 and the guide rod 4 are located in the active area 201. The movable leaflet 3 is mounted on the guide rod 4 and can move 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 of the guide hole 101 (refer to Figure 3 and Figure 4 ), or the movable leaflet 3 can movably close the entire passage 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 that of 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.

[0052] 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 sealing 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;

[0053] 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 guide 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.

[0054] In the present invention, the movable leaflet 3, in conjunction with the guide rod 4, can be reciprocated vertically. Compared to existing mechanical valves, this valve has no slots or shafts, effectively preventing thrombosis and extending the lifespan of the valve. It is also less susceptible to damage and can be used for extended periods. Even if a thrombus forms, it is less likely to become stuck, thus avoiding valve obstruction or functional impairment. Furthermore, because it is less susceptible to thrombosis, patients require minimal or no anticoagulation during use.

[0055] 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 annuli. Implantation often requires methods such as tilting the valve or expanding the valve annulus. At the same time, the transvalvular pressure difference is too high, affecting the patient's heart function and the life of the valve.

[0056] 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 biological valve at the conducting hole 101 (i.e., the valve orifice). Compared with the existing valves of the same model, 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 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.

[0057] Of course, the mechanical valve can also be implanted and replaced in the aortic valve or pulmonary valve, so that the limiting base 2 is located in the aorta or pulmonary artery and plays a unidirectional conduction role along the direction of blood flow.

[0058] In some embodiments, as Figure 5 shown. Figure 5 Schematic diagram of the movable leaflet 3 in the present invention. Specific structure of the movable leaflet 3 and the coordination principle between the movable leaflet 3 and the guide rod 4. Specifically:

[0059] 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;

[0060] 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 .

[0061] In this embodiment, if Figure 5 As 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 thrombosis, stuck leaflet, functional disorder, etc. Therefore, the frequency of coagulation treatment can be reduced.

[0062] In addition, due to the mechanical characteristics 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 having a strong impact on 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.

[0063] In some embodiments, as Figure 1 shown. Figure 1 This 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 have opening areas for blood circulation, so that the limit base 2 has a hollow structure.

[0064] 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 .

[0065] like Figure 2 shown. Figure 2 This is a cross-sectional view of the movable leaflet 3 and the conducting 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 arched section 502, and a second connecting part 503 connected in sequence;

[0066] The first end of the first connecting member 501 is connected to one side of the open end of the arched segment 502, and the first end of the second connecting member 503 is connected to the other side of the open end of the arched segment 502;

[0067] 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 height of the limiting base 2 , and the bottom end of the guide rod 4 is installed to the middle of the arched section 502 .

[0068] like Figure 6 shown. Figure 6 This is a cross-sectional view of the movable leaflet 3 of the present invention. In this embodiment, the movable leaflet 3 is provided with an arched cavity 303, and the curvature of the outer portion of the arched segment 502 is equal to or less than that of the arched cavity 303. In this embodiment, as the movable leaflet 3 moves downward along the trajectory of the guide rod 4, the arched cavity 303 provided within the movable leaflet 3 provides support for the movable leaflet 3 as it slides downward along the guide rod 4, further preventing it from becoming stuck.

[0069] In some embodiments, as Figure 7 shown. Figure 7 This is a perspective view of another embodiment of a mechanical valve according to the present invention. The structure of this mechanical valve differs from that of the aforementioned embodiment in that the first support member 5 is a crossbar. 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 connected to the bottom end of the guide rod 4, so that the first support member 5 and the guide rod 4 are arranged perpendicularly. The first support member 5 and the guide rod 4 together support and guide the movable leaflet 3.

[0070] In addition, if Figure 8 shown. Figure 8 This is a cross-sectional view of another embodiment of the mechanical valve of the present invention. In this embodiment, the bottom of the movable leaflet 3 is a solid surface structure. An arched cavity 303 may also be formed at the bottom of the movable leaflet 3. The provision of arched cavity 303 facilitates smooth blood flow in pushing the movable leaflet 3 to block the conduction hole 101 during ventricular contraction, reduces material costs, and reduces the weight of the movable leaflet 3.

[0071] In some embodiments, as Figure 1 shown. Figure 1 The figure is a three-dimensional schematic diagram of the present invention. Regarding the connection structure between the limiting base 2 and the mechanical valve ring 1, specifically: 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, such as Figure 1 As shown, there are two supporting legs 7, which 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 support 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.

[0072] 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 smaller than the inner diameter of the active area 201 surrounded by the support legs 7 . This enables the movable leaflet 3 to move freely up and down in the active area 201 .

[0073] In some embodiments, as Figure 1 shown. 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.

[0074] 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 annulus 1, leaving a margin of motion 400 for the movable leaflet 3 along the trajectory of the guide rod 4. When the movable leaflet 3 moves upward along the guide rod 4, closing the guide hole 101, the top convex surface 302 of the movable leaflet 3 can extend outside the mechanical annulus 1.

[0075] 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 atria, ventricles or blood vessels.

[0076] In some embodiments, as Figure 1 shown. Figure 1 This is a three-dimensional schematic diagram of the present invention. 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. This annular sewing ring 8 facilitates the suturing and fixation of the mechanical valve ring 1 to the autologous valve. This annular sewing ring 8 is a common structure.

[0077] In the description of the present invention, it should be noted that the terms "comprises," "includes," or any other variations thereof are intended to encompass non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus. In the absence of further limitations, an element defined by the phrase "comprising a..." does not preclude the presence of other identical elements in the process, method, article, or apparatus comprising the element.

[0078] In addition, in the description of the present invention, the terms "upper", "lower", "front", "back", "left", "right", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and 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 orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0079] On the other hand, it should be noted that, unless otherwise expressly specified or 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 a direct connection or an indirect connection through an intermediate medium, or it can be a communication between the two elements. As used 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 on a case-by-case basis.

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 mounted 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 movable 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 reciprocate up and down along the trajectory of the guide rod, so that the movable leaflet can movably open or close the entire passage opening of the guide hole. 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 slides back and forth up and down along the trajectory direction of the guide rod; 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 installed on the first supporting member.

2. The single-leaflet mechanical valve according to claim 1, characterized in that The first supporting member includes 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 in the middle of the arched section; Correspondingly, 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.

3. The single-leaflet mechanical valve according to claim 1, 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.

4. The single-leaflet mechanical valve according to claim 2, 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.

5. The single-leaflet mechanical valve according to claim 4, 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 trajectory direction of the guide rod.

6. The single-leaflet mechanical valve according to claim 4, 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 active 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.

7. The single-leaflet mechanical valve according to claim 1, characterized in that The top convex surface of the mobile leaflet extends to the outside of the mechanical valve ring.

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

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