Mechanical heart valve

Abstract

A mechanical heart valve (10) comprises an annular support (12) having an anterior portion (14) and a posterior portion (16), a first leaflet (18) oscillatingly connected to the anterior portion (14) of the annular support (12), and a second leaflet (20) oscillatingly connected to the posterior portion (16) of the annular support (12). The mechanical heart valve (10) is configured to alternately assume a closed condition in which the first leaflet (18) and the second leaflet (20) seal the mechanical heart valve (10), and an open condition in which the first leaflet (18) has a first opening angle (α) relative to the annular support (12) and the second leaflet (20) has a second opening angle (β) relative to the annular support (12).

Description

[0001] Mechanical heart valve

[0002] Technical field

[0003] The present invention relates to a mechanical heart valve. In particular, but not exclusively, the present mechanical heart valve may be applied as a mitral valve, arranged between the left atrium and the left ventricle of the heart.

[0004] Prior art

[0005] There are four cardiac chambers and four cardiac valves in the heart, two atrioventricular valves separating the atria and ventricles, and two semilunar valves separating the ventricles and the pulmonary artery or aorta, respectively. The mitral valve is the atrioventricular valve that separates the left atrium from the left ventricle.

[0006] The cardiac chambers are physiologically asymmetrical. The mitral valve also has an asymmetrical anatomy in the shape of the mitral ring, in the shape of the leaflets and in the position of the papillary muscles. It follows that the trans-mitral flow has a substantially inclined direction, directed towards the posterior wall of the left ventricle, creating a natural rotary movement of the blood within the ventricle, also known in the field as a “vortex”.

[0007] The formation of the vortex in the left ventricle is a fundamental physiological condition for the hemodynamics of the blood flow in the heart. The absence or alteration of the mechanism of the formation of the blood vortex leads to non-physiological hemodynamics, the main negative consequences of which are pumping energy inefficiency, high risk of thrombus formation, and remodeling of the left ventricle. In particular, in the absence of the formation of a ventricular vortex, a physiological heart would consume a greater amount of energy. This energy consumption is even more accentuated when the ventricular function of the heart is impaired, such as in the case of functional mitral insufficiency.

[0008] To date, repair of the mitral valve is preferred, for example by means of transcatheter or open-heart techniques, over its replacement. When the only possible solution is to replace the mitral valve, the recommendations of the scientific community are to use mechanical valves in patients under 65 years of age (“2020 ACC / AHA Guideline for the Management of Patients With Valvular Heart Disease”) to reduce the risk of reintervention and to increase the survival of the individual (Kaneco T. et al. “Mechanical and bioprosthetic replacement of the mitral valve in patients under the age of 65. ” J Thorac Cardiovasc Surg 2014; 147(1): 117-26). Long-term results confirm the superiority of mechanical versus biological valves in patients up to 65 years of age (Goldstone A.B. et al. “Mechanical or biological prostheses for the replacement of the aortic valve and the mitral valve”. N Engl J Med 2017; 377: 1847-1857).

[0009] Typically, mitral mechanical prostheses are designed in a similar way to an aortic prosthesis, i.e., they have a circular ring and a central opening or opening for the passage of the blood flow, which is substantially perpendicular to the ring of said valve. Although these valves have proven to be effective and have excellent performance in preventing blood regurgitation in the atrium, they have limitations, including hemodynamic performance not comparable to that of a physiological mitral valve, heart fatigue during the action of pumping blood, turbulence in the blood flow directed to the left ventricle, and an increased risk of thrombus formation.

[0010] Summary of the invention

[0011] It is an object of the present invention to construct mechanical heart valves that are capable of ensuring a physiological rotary (or vortex) movement of the blood during the passage thereof from the left atrium to the left ventricle.

[0012] A further object of the present invention is to construct mechanical heart valves configured to reduce unwanted or excessive turbulence in the blood flow directed to the left ventricle, resulting in reduced thrombus formation.

[0013] Another object of the present invention is to construct mechanical heart valves configured to facilitate blood recirculation or lavage in the left ventricle, minimizing the areas of the ventricle prone to stasis and / or blood accumulation. These and other objects and advantages, which will be better understood in the following, are achieved according to the invention having the features defined in the accompanying claims.

[0014] In short, a mechanical heart valve configured to be arranged between the left atrium and the left ventricle of a heart comprises an annular support having an anterior portion and a posterior portion, a first leaflet oscillatingly connected to the anterior portion of the annular support and a second leaflet oscillatingly connected to the posterior portion of the annular support. The mechanical heart valve is configured to alternately assume a closed condition wherein the leaflets seal the mechanical heart valve and an open condition wherein the first leaflet has a first opening angle relative to the annular support and the second leaflet has a second opening angle relative to the annular support.

[0015] Brief description of the drawings

[0016] The features and advantages of the invention will emerge from the detailed description of some exemplary embodiments made with reference to the accompanying drawings, given as an indication and not intended to be limiting, wherein:

[0017] Fig. 1 is a perspective view of an embodiment of a mechanical heart valve in an open condition,

[0018] Fig. 2 is a cross-sectional perspective view of the mechanical heart valve of Fig. 1,

[0019] Fig. 3 is a side view of the mechanical heart valve of Fig. 1,

[0020] Fig. 4 is a cross-sectional side view of the mechanical heart valve of Fig. 3,

[0021] Fig. 5 is a top view of the mechanical heart valve of Fig. 1,

[0022] Fig. 6 is a perspective view of the mechanical heart valve of Fig. 1 in a closed condition,

[0023] Fig. 7 is a side view of the mechanical heart valve of Fig. 6,

[0024] Fig. 8 is a cross-sectional side view of the mechanical heart valve of Fig. 7,

[0025] Fig. 9 is a top view of the mechanical heart valve of Fig. 6,

[0026] Fig. 10 is a perspective view of an alternative embodiment of a mechanical heart valve in an open condition, Fig. 11 is a cross-sectional perspective view of the mechanical heart valve of Fig. 10, Fig. 12 is a side view of the mechanical heart valve of Fig. 10,

[0027] Fig. 13 is a cross-sectional side view of the mechanical heart valve of Fig. 12,

[0028] Fig. 14 is a top view of the mechanical heart valve of Fig. 10,

[0029] Fig. 15 is a perspective view of an alternative embodiment of a mechanical heart valve in an open condition,

[0030] Fig. 16 is a cross-sectional perspective view of the mechanical heart valve of Fig. 15, Fig. 17 is a cross-sectional side view of the mechanical heart valve of Fig. 15, Fig. 18 is a perspective view of the mechanical heart valve of Fig. 15, in a closed condition, and

[0031] Fig. 19 is a cross-sectional side view of the mechanical heart valve of Fig. 18.

[0032] Detailed description

[0033] A mechanical heart valve according to the present invention is configured to be arranged or implanted between the left atrium and the left ventricle of a patient’s heart, i.e., it is a mechanical heart valve configured to be placed as a replacement of a patient’s native mitral valve.

[0034] In an implanted condition, i.e., when arranged within the heart of a patient, the mechanical heart valve of the present invention allows terms and orientations to be defined such as “anterior”, “posterior”, “upper”, and “lower”. The term “anterior” refers to the portion of the mechanical heart valve facing the interventricular septum in the implanted condition. The term “posterior” refers to the portion of the mechanical heart valve facing the posterior wall and / or the side wall of the left ventricle in the implanted condition. The term “upper” refers to the face of the mechanical heart valve facing the atrium, i.e., a direction upstream of the patient’s blood flow in the implanted condition. The term “lower” refers to the face of the mechanical heart valve facing the ventricle, i.e., in a direction downstream of the patient’s blood flow in the implanted condition.

[0035] As illustrated in the figures, the mechanical heart valve 10 of the present invention comprises an annular support 12 having an anterior portion 14 and a posterior portion 16 and also comprising two leaflets or membranes 18, 20, where a first leaflet or anterior leaflet 18 is connected to the anterior portion 14 of the annular support 12 and a second leaflet or posterior leaflet 20 is connected to the posterior portion 16 of the annular support 12.

[0036] Preferred embodiments may have an annular support 12 having an overall D shape, i.e., a shape wherein the anterior portion 14 has a smaller curvature than the posterior portion 16 (Fig. 1, 5, 10 and 14). For example, the anterior portion 14 may be linear and the posterior portion 16 may be semi-elliptical. In other words, the anterior portion 14 and the posterior portion 16 of the annular support 12 may have different shapes to each other.

[0037] The annular support 12 may be provided with an annular protrusion 15, also known as a “sewing ring”, which protrudes externally from the same annular support 12 and may be made of synthetic fabric, for example polyethylene terephthalate. The annular protrusion 15 may be advantageously handled by the surgeon, preventing damage to other, more delicate components such as the leaflets 18, 20, and may be used for anchoring the sutures to anchor the annular structure 12 to the patient’s mitral valve ring.

[0038] In an alternative embodiment, the annular support 12 may have an elongated, overall elliptical shape (Fig. 15). In other words, the anterior portion 14 and the posterior portion 16 may have corresponding shapes to each other. For example, the anterior portion 14 and the posterior portion 16 may both have an overall C-shape.

[0039] In an alternative embodiment, the annular support 12 may have an elongated shape, which is generally rectangular.

[0040] In an alternative embodiment, the annular support 12 may have an overall trapezoidal shape, wherein the posterior portion may be smaller than the anterior portion.

[0041] The annular protrusion 15 may be provided with visual indicators, e.g., notches or graphical markings, arranged to be aligned with natural commissures, i.e., with the connection points between the leaflets and ring of the native mitral valve, during implantation of the mechanical heart valve 10. The two leaflets 18, 20 may have different dimensions from each other. Preferably, the first leaflet or anterior leaflet 18 may be larger in size than the second leaflet or posterior leaflet 20. Preferably, the first leaflet 18 may have a surface extension or area of between 55% and 65% and the second leaflet 20 may have a surface extension or area of between 35% and 45% of the size of an inner space or opening 11 formed by the annular support 12 for the passage of the blood flow. For example, the first leaflet may have a surface or area equal to 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64% or 65% and the second leaflet may have a surface or area equal to 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44% or 45% of the size of the opening 11.

[0042] Additionally or alternatively, the first leaflet 18 may be longer than the second leaflet 20, i.e., it may extend in a direction away from the connection zone between the leaflet 18 and the annular support 12 by a greater amount with respect the second leaflet 20. Preferably, the first leaflet 18 may extend in a direction away from the connection or junction zone between the first leaflet 18 and the annular support 12 by a length of between 55% and 65% of the length of the opening 11, i.e., the size of the opening 11 in the anterior-posterior direction. For example, the first leaflet 18 may have a length equal to 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64% or 65%.

[0043] Preferably, the second leaflet 20 may extend in a direction away from the connection or junction zone between the second leaflet 20 and the annular support 12 by a length of between 35% and 45% of the length of the opening 11, i.e., the size of the opening 11 in the anterior-posterior direction. For example, the second leaflet 20 may have a length equal to 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%.

[0044] A valve 10 with leaflets 18, 20 having different dimensions from each other advantageously allows the blood flow, which passes through the mechanical heart valve in the implanted condition, to be directed in a desired direction, preferably, a direction inclined toward the posterior wall of the left ventricle, facilitating the formation of a vortex of blood flow in the left ventricle. The leaflets 18, 20 may be flat, or concave or convex towards the left ventricle, or combinations thereof when the mechanical heart valve 10 is in the implanted condition.

[0045] The opening 11 formed internally by the annular support 12 may be delimited by an inner surface 13 having an anterior part 13 a, arranged at the anterior portion 14 of the annular support 12, and a posterior part 13b, arranged at the posterior portion 16 of the annular support (Fig. 4, 5, 13, 14 and 15).

[0046] The first leaflet 18 may have two contact points 22a, 22b with the anterior portion 14 of the annular support 12 which may define a straight line which may be found adjacent to the anterior portion 13a of the inner surface 13 of the opening 11 of the annular support 12 (Fig. 4, 5, 13, 14 and 15).

[0047] Preferably, the second leaflet 20 may have two contact points 24a, 24b with the posterior portion 16 of the annular support 12 defining a straight line being secant to the opening 11, i.e., a straight line which is located between the posterior portion 13b of the inner surface 13 and a central point of the opening 11 of the annular support 12 (Fig. 4, 5, 13 and 14).

[0048] In an alternative embodiment (Fig. 15), the second leaflet 20 may have two contact points 24a, 24b with the posterior portion 16 of the annular support 12 defining a straight line that may be found adjacent to the posterior portion 13b of the inner surface 13 of the opening 11 of the annular support 12.

[0049] In one embodiment, the opening 11 may form three lumens I la, 11b, 11c or passages for blood flow, i.e., the support ring 12 may form three lumens with the first leaflet 18 and the second leaflet 20 (Fig. 5 and 14). Wherein a first lumen or main lumen 1 la may be formed between the inner surface 13, the first leaflet 18 and the second leaflet 20, a second lumen 1 lb may be formed between the second leaflet 20 and the posterior portion 13b of the inner surface 13 of the annular support 12, and a third lumen 11c may be formed between the first leaflet 18 and the anterior portion 13a of the inner surface 13 of the annular support 12. For example, the main lumen 1 la may be larger than the second 1 lb and third 11c lumen. In an alternative embodiment, the opening 11 may form a single central lumen for the passage of the blood flow.

[0050] The contact points 22a, 22b, 24a, 24b may comprise cantilevered protrusions or projections 30, e.g., cylindrical pins or fins, made on perimetrically outer surfaces of the leaflets 18, 20 arranged to engage in respective niches or cavities 32 made in the inner surface 13 of the annular support 12 (Fig. 2 and 11).

[0051] The niches 32 may be suitably shaped (Fig. 2 and 11) so as to limit the movement of the cantilevered protrusions 30 and, therefore, of the leaflets 18, 20 to predetermined opening and closing angles.

[0052] In an alternative embodiment (Fig. 15), the niches 32 may be cylindrical cavities, the cantilevered protrusions 30 may be cylindrical pins, and locking elements 33 may be present arranged on the inner surface 13 of the support 12 to limit the movement of the protrusions 30 and, therefore, of the leaflets 18, 20.

[0053] The mechanical heart valve 10, in any one of the embodiments described thus far, is configured to alternately assume a closed condition, in which the first leaflet 18 and the second leaflet 20 seal the mechanical heart valve 10, and an open condition, in which the first leaflet 18 has a first maximum opening angle a relative to the annular support 12 and the second leaflet 20 has a second maximum opening angle P relative to the annular support 12 (Fig. 4, 13 and 17). The maximum opening angles a and P may be defined and / or measured between the respective leaflet 18, 20 and a plane defined by the contact points 22a, 22b, 24a, 24b of the leaflets 18, 20 to the annular support 12 (Fig. 4, 13, 17).

[0054] The first opening angle a of the first leaflet 18 with respect to the annular support 12 may be in the range of about 50° to about 90°. Preferably, the first opening angle a may be in the range of about 60° to about 80°. Preferably, the first opening angle a may be in the range of about 65° to about 75°. Even more preferably, the first opening angle a of the first leaflet 18 with respect to the annular support 12 may be about 70°. For example, the first opening angle a may be 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85° or 90°. The second opening angle P of the second leaflet 20 with respect to the annular support 12 may be in the range of about 70° to about 100°. Preferably, the second opening angle P may be in the range of about 70° to about 80°, and / or preferably, the second opening angle P may be in the range of about 80° to about 90°. For example, the second opening angle P may be 70°, 75°, 80°, 85° or 90°.

[0055] In embodiments of a mechanical heart valve 10, the first opening angle a and the second opening angle P may be different from each other. For example, the first leaflet 18 may have an opening angle a of about 70° with the annular support 12 and the second leaflet 20 may have an opening angle P of about 90° with the annular support 12. For example, the first leaflet 18 may have an opening angle a of about 70° with the annular support 12, and the second leaflet 20 may have an opening angle P of about 80° with the annular support 12. For example, the first leaflet 18 may have an opening angle a of about 70° with the annular support 12 and the second leaflet 20 may have an opening angle P of about 70° with the annular support 12.

[0056] Embodiments of the mechanical heart valve 10 may provide for the first leaflet 18 and / or the second leaflet 20 and / or the support ring 12 to be configured in such a way that in the open condition, i.e., when the leaflets 18, 20 form a respective angle with the support ring 12, an edge of a proximal end of the first leaflet 18 and / or of the second leaflet 20, i.e., the end of the leaflet 18, 20 in which there are contact points 22a, 22b, 24a, 24b with the annular support

[0057] 12, is in contact with the respective part 13a, 13b of the inner surface 13 of the opening 11 (Fig. 16), preventing the passage of blood flow between the respective leaflet 18, 20 and the portion 13a, 13b of the inner surface 13 of the opening 11. In other words, the edge of a proximal end of the first leaflet 18 and / or the second leaflet 20 does not move away from the inner surface 13 of the opening 11.

[0058] In such an embodiment, the opening 11 may form a single lumen or two lumens. For example, when two lumens are formed, a lumen may be formed between the inner surface

[0059] 13, the first leaflet 18, and the second leaflet 20, and a second lumen may be formed between the second leaflet 20 and the posterior portion 13b of the inner surface 13, or a second lumen may be formed between the first leaflet 18 and the anterior portion 13a of the inner surface 13.

[0060] To allow the mechanical heart valve 10 to assume the alternately open and closed conditions, the first leaflet 18 is oscillatingly connected to the anterior portion 14 of the annular support 12, and the second leaflet 20 is oscillatingly connected to the posterior portion 16 of the annular support 12. In other words, the first leaflet 18 and the second leaflet 20 are rotatable, about the respective connection points 22a, 22b, 24a, 24b, with respect to the relative portion 14, 16 of the annular support 12.

[0061] The opening 11 identified by the annular support 12 is intended to be alternately open and occluded by the oscillation movement of the two leaflets 18, 20.

[0062] Embodiments of the mechanical heart valve 10 (Fig. 1-5 and Fig. 10-14), may have the first leaflet 18 and the second leaflet 20 configured to oscillate in concordant directions in an opening phase from the closed condition to the open condition of the mechanical heart valve 10 and in a closing phase from the open condition to the closed condition of the mechanical heart valve 10. In other words, the first 18 and the second 20 leaflets may be configured to oscillate or rotate in the same direction of rotation about the respective connection points 22a, 22b, 24a, 24b, both in the opening and closing phases.

[0063] The embodiments in which the two leaflets 18, 20 are configured to oscillate in concordant directions allow advantageously the flow of blood, which passes through the mechanical heart valve in the implanted and open condition, to be directed to a desired direction, preferably inclined towards the posterior wall of the left ventricle, facilitating the formation of a vortex of blood flow in the left ventricle.

[0064] In one embodiment, the first leaflet 18 and the second leaflet 20 may be configured to be substantially parallel to each other during the entire or at least part of the opening phase and during the entire or at least part of the closing phase of the mechanical heart valve. In other words, the first leaflet 18 and the second leaflet 20 may be configured to oscillate or rotate at the same rotation speed about the respective connection points 22a, 22b, 24a, 24b in the opening phase and in the closing phase.

[0065] The first 18 and the second 20 leaflets each have a respective upper face 18a, 20a and a respective lower face 18b, 20b. When the mechanical heart valve is in the open condition, the upper face 18a of the first leaflet 18 may face a lower face 20b of the second leaflet 20 (Fig. 4 and 13). The upper face 18a of the first leaflet 18 may face a lower face 20b of the second leaflet 20 even during the opening phase of the mechanical heart valve 10.

[0066] An alternative embodiment (Fig. 15-17) may have the first leaflet 18 and the second leaflet 20 configured to oscillate with discordant directions in an opening phase from the closed condition to the open condition of the mechanical heart valve 10 and in a closing phase from the open condition and to the open condition of the mechanical heart valve 10. In other words, the first 18 and the second 20 leaflets may be configured to oscillate or rotate in opposite directions about the respective connection points 22a, 22b, 24a, 24b, both in the opening and closing phases of the mechanical heart valve.

[0067] Preferably, the first leaflet 18 and the second leaflet 20 are configured to oscillate divergently in an opening phase from the closed condition to the open condition of the mechanical heart valve 10 and to oscillate convergently in a closing phase from the open condition to the open condition of the mechanical heart valve 10.

[0068] The annular support 12 and / or the first leaflet 18 and / or the second leaflet 20 may be made of a material selected from the group consisting of graphite, pyrolytic carbon, titanium, titanium alloys, alumina, zirconium oxide, polymers, polyether ketone or combinations thereof.

[0069] When made of such materials, the anterior 18 and posterior 20 leaflets may be in the form of sheets or wings that are rigid, non-deformable and rotatable with respect to the annular support 12.

[0070] Preferably, the first leaflet 18 and / or the second leaflet 20 may be made of or coated with pyrolytic carbon because it is a material that is highly biocompatible, has high wear resistance and is able to ensure a smooth annular support surface 12 and leaflets 18, 20, minimizing the formation of clots.

[0071] Titanium and its alloys may advantageously be used for the annular support 12 and / or for the leaflets 18, 20 and / or for the connection points 22a, 22b, 24a, 24b between the leaflets 18, 20 and the annular support 12 because it is a material with high corrosion resistance and is biocompatible.

[0072] Polymer materials, including polyether ether ketone, may advantageously be used to make or coat the annular support 12 and / or the leaflets 18, 20 as they are highly biocompatible and have low platelet adhesion and formation of clots on the surfaces of the valve 10 that may generate thrombi.

[0073] Subject to the principle of the invention, the details of embodiment and implementation may vary widely from that which is described and illustrated, without departing from the scope of the present invention as identified by the claims that follow.

Claims

CLAIMS1. A mechanical heart valve (10) configured to be arranged between the left atrium and the left ventricle of a heart, said mechanical heart valve (10) comprising:- an annular support (12) having an anterior portion (14) and a posterior portion (16),- a first leaflet (18) oscillatingly connected to the anterior portion (14) of the annular support (12), and- a second leaflet (20) oscillatingly connected to the posterior portion (16) of the annular support (12), wherein the mechanical heart valve (10) is configured to alternately assume:- a closed condition wherein the leaflets (18, 20) seal the mechanical heart valve (10), and- an open condition wherein the first leaflet (18) has a first opening angle (a) relative to the annular support (12) and the second leaflet (20) has a second opening angle (P) relative to the annular support (12).

2. The mechanical heart valve (10) according to claim 1, the annular support (12) internally forms an opening (11) and wherein the first leaflet (18) has an area of between 55% and 65% of the dimension of the opening (11) and the second leaflet (20) has an area of between 35% and 45% of the dimension of the opening (11).

3. The mechanical heart valve (10) according to claim 1 or 2, wherein the annular support (12) internally forms an opening (11) and wherein the first leaflet (18) extends in a direction away from the connection zone between the first leaflet (18) and the annular support (12) by a length of between 55% and 65% of the length of the opening (11) and where the second leaflet (20) extends in a direction away from the connection zone between the second leaflet (20) and the annular support (12) by a length of between 35% and 45% of the length of the opening (11).

4. The mechanical heart valve (10) according to any one of the preceding claims, wherein the first leaflet (18) has a maximum first opening angle (a) in the range of about 50° to about 90°, preferably in the range of about 60° to about 80°, preferably 70°.

5. The mechanical heart valve (10) according to any one of the preceding claims, wherein the second leaflet (20) has a second maximum opening angle (P) in the range of about 70° to about 100°, preferably in the range of about 70° to about 80°, and / or preferably in the range of about 80° to about 90°.

6. The mechanical heart valve (10) according to any one of the preceding claims, wherein the annular support (12) and / or the first leaflet (18) and / or the second leaflet (20) are made of a material selected from the group consisting of graphite, pyrolytic carbon, titanium, titanium alloys, alumina, zirconium oxide, polymers, polyether ether ketone or combinations thereof.

7. The mechanical heart valve (10) according to any one of the preceding claims, wherein annular support (12) has an overall D shape.

8. The mechanical heart valve (10) according to any one of claims 1 to 6, wherein the annular support (12) has an overall elliptical shape.

9. The mechanical heart valve (10) according to any one of claims 1 to 6, wherein annular support (12) has an overall rectangular shape.

10. The mechanical heart valve (10) according to any one of the preceding claims, wherein the annular support (12) internally forms an opening (11) delimited by an inner surface (13) having an anterior part (13a) and a posterior part (13b), the first leaflet (18) has two contact points (22a, 22b) with the anterior portion (14) of the annular support (12), said two contact points (22a, 22b) defining a straight line being adjacent to the anterior portion (13a) of the inner edge (13) of the opening (11) of the annular support (12), and the second leaflet (20) has two contact points (24a, 24b) with the posterior portionbeing secant to the opening (11), between the posterior portion (13b) of the inner surface (13) and a central point of the opening (11) of the annular support (12).

11. The mechanical heart valve (10) according to any one of the preceding claims, wherein the first leaflet (18) and the second leaflet (20) are configured to oscillate with concordant directions in an opening phase from the closed condition to the open condition of the mechanical heart valve (10) and in a closing phase from the open condition to the closed condition of the mechanical heart valve (10).

12. The mechanical heart valve (10) according to any one of the preceding claims, wherein an upper face (18a) of the first leaflet (18) faces towards a lower face (20b) of the second leaflet (20) in the open condition of mechanical heart valve (10).

13. The mechanical heart valve (10) according to any one of the claims 1 to 9, wherein the annular support (12) internally forms an opening (11) delimited by an inner surface (13) having an anterior part (13a) and a posterior part (13b), the first leaflet (18) has two contact points (22a, 22b) with the anterior portion (14) of the annular support (12), said two contact points (22a, 22b) defining a straight line being adjacent to the anterior portion (13a) of the inner surface (13) of the opening (11) of the annular support (12), and the second leaflet (20) has two contact points (24a, 24b) with the posterior portion (16) of the annular support (12), said two contact points (24a, 24b) defining a straight line being adjacent to the posterior portion (13b) of the inner surface (13) of the opening (11) of the annular support (12).

14. The mechanical heart valve (10) according to any one of claims 1 to 9 or according to claim 13, wherein the first leaflet (18) and the second leaflet (20) are configured to oscillate in discordant directions in an opening phase from the closed condition to the open condition of the mechanical heart valve (10) and in a closing phase from the open condition to the closed condition of the mechanical heart valve (10).

15. The mechanical heart valve (10) according to any one of claims 1 to 9 or claim 13 or 14, wherein the first leaflet (18) and the second leaflet (20) are configured to oscillate divergently in an opening phase from the closed condition to the open condition of the mechanical heart valve (10) and to oscillate convergently in a closing phase from the open condition and to the open condition of the mechanical heart valve (10).

16. The mechanical heart valve (10) according to any one of claims 10 to 15, wherein an edge of a proximal end of the first leaflet (18) and / or the second leaflet (20) is in contact with the part (13a, 13b) of the inner surface (13) of the opening (11).

17. The mechanical heart valve (10) according to any one of claims 10 to 15, wherein the opening (11) forms three lumens (I la, 11b, 11c), and wherein a first lumen (I la) is formed between the inner surface (13), the first leaflet (18), and the second leaflet (20), a second lumen (11b) is formed between the second leaflet (20) and the posterior portion (13b) of the inner surface (13), and a third lumen (11c) is formed between the first leaflet (18) and the anterior portion (13a) of the inner surface (13).

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