MXPA00011791A - Mechanical heart valve - Google Patents

Abstract

The present invention relates to an improved trileaflet mechanical heart valve (100) and an improved leaflet (110) for use with such valve. The valve (100) and leaflet (110) of the present invention provide improved flow characteristics, minimize blood clotting behind the leaflets, and provide more natural opening and closing times. The valve includes a valve housing (105) which contains pivot/hinge mechanism (130, 200, and 300) for allowing rotation of and retention of the leaflets (110). The valve housing (105) also includes windows or openings (125) which allows for complete washing of the pivot/hinge mechanism (130, 200, and 300) as well as the leaflets (110). The novel leaflets (110) are airfoil-like having a complex S-shaped curvature on their outer surface. This novel geometry, when combined with the location of the leaflet's pivot axis, causes a tendency for the leaflet (110) to rotate towards the closed position. Thus, the leaflet (110) begins to close much earlier than a conventional leaflet and is substantially closed before the flow reverses, similar to the function of a natural valve.

Description

T MECHANICAL HEART VALVE BRIEF DESCRIPTION OF THE INVENTION • This application claims priority under 35 U.S.C. §119 (e) for the North American Provisional Application No. 5 60 / 088,184, filed on June 5, 1998, and under 35 U.S.C. §120 for the North American Series No. 09 / 035,981, entitled MECANICAL VALVE PROSTHESIS ITH OPTIMIZED CLOSING MODE filed on March 6, 1998, the description of which is expressly incorporated herein by reference, and its # 10 North American patent application Series No. 08 / 859,530, filed on May 20, 1997, currently abandoned. The present invention relates to an improved three-tailed mechanical heart valve. More specifically, the present invention relates to a three-tailed mechanical heart valve with improved flow characteristics. Such a mechanical heart valve is useful for surgical implantation in a • Patient as a replacement for a damaged or diseased heart valve. 20 There are numerous considerations in the design and manufacture of a mechanical prosthetic heart valve. An important consideration is the biocompatibility of the materials used in the prosthesis. The materials used must be compatible with the body and with the blood. In addition, the materials must be inert with respect to the natural blood coagulation process, that is, they must not induce thrombosis (an accumulation of factors • blood, mainly platelets and fibrin with entrapment of cellular elements, often causing tipping to the point of this information) when connected by the blood flow. A local thrombus results in an embolism (the sudden blockage of a blood-carrying spleen) and even under certain circumstances can stop the operation of the valve properly. HE have tested numerous materials for desirable biocompatibility. Various materials are commonly used to make commercially available prosthetic heart valves (such as stainless steel, chromium alloys, titanium and its alloys, and pyrolytic carbon). 15 Another consideration in the design and manufacture of a mechanical prosthetic heart valve is the ability of the valve to provide fluid flow performance • optimal. Mechanical prosthetic heart valves often create areas of turbulent flow, swirls and areas of stagnation. All these phenomena can also lead to thrombosis and thromboembolism. Biological valves (or bioprostheses) emulate the shape and flow pattern of the natural heart valve and thus have better fluid flow performance over mechanical prostheses conventional. Such bioprosthetic valves do not require that ^ j ^^^^ ¡^^^^ j ^ j ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ ^^^^^ &4affltfBl MA long-term anticoagulant medication is taken by the patient after implantation at least in the • aortic position. These two thrombo-generating factors (materials used and flow characteristics) are problems in conventional mechanical heart valve prostheses. Thus, patients currently receiving a mechanical heart valve prosthesis require a continuous regimen of anticoagulant drugs that can result in bleeding problems. The use of drugs ^^ 10 anticoagulants therefore constitutes a major disadvantage of mechanical heart prosthetic valves when compared to bioprostheses. However, biological replacement valves suffer from problems as well. As the experience has indicated clinical, unlike mechanical valves, often its duration is short too. Due to the progressive deterioration of the bioprosthesis, they often need to be • replaced by very expensive additional specialty surgery. 20 Still another consideration in the design and manufacture of a mechanical prosthetic heart valve has to do with the loss of the head (pressure loss) associated with the valve. This loss of the head occurs during systolic ejection or diastolic filling of a ventricle.

In conventional designs, some loss of the head is inevitable since it is inherent to the reduction in the effective orifice area of the mechanical prosthetic heart valve • when compared to natural valves. The reduction in the effective orifice is caused by the stitched ring that is conventionally required for the surgical installation of the prosthetic valve, by the thickness of the valve housing, and by the joints that enable the valve flaps (tabs). to move between an open and closed position. Another portion of the head loss is due to • 10 the geometric arrangement of the flaps of the valve with respect to blood flow. As mentioned in the above regarding the progressive deterioration of the bioprosthesis, durability is another consideration in the design and manufacture of a valve of mechanical prosthetic heart. A mechanical prosthetic heart valve must demonstrate a mechanical life equivalent to approximately 380-600 million cycles (ie, the equivalent of approximately 15 years). Obviously, the mechanical life is related to the design geometric valve as well as the mechanical characteristics of the materials used. Of course, the ability of the valve to decrease the exhaust is also important. Usually the escape includes regurgitation (delayed blood flow through the valve during operation, and otherwise known as dynamic exhaust) and static exhaust (any flow through the valve in the fully closed position) • closed) . In conventional valves, the amount of regurgitation is at least 5% of the blood flow volume during each cycle, and often more. When a patient has two prosthetic valves in the same ventricle, the regurgitation (dynamic escape) thus comprises at least about 10% (escape in the order of several hundred L per day). In this way, the escape • Dynamic 10 clearly puts undesirable stress on the heart muscle. The static leak, in the other band, is typically caused by imperfect mechanical rise of the prosthetic valve when its flaps close. Because the static exhaust also causes it to work harder on heart muscle, the design and manufacture of a mechanical prosthetic heart valve should be taken into consideration. The closed mechanism of natural heart valves has not been taken into account in the design of conventional mechanical valve prostheses. When the flow rate through the valve starts from scratch, the natural aortic valve is already closed to more than 90%. In contrast, conventional mechanical valve prostheses at the same time remain almost completely open. From this almost completely open position, the tabs of conventional mechanical valve abruptly close with the ñÜIMH- 'mrír? it t large amount of regurgitation. In an aortic position, this occurs at the beginning of the diastole, and in the mitral position, • this occurs even more abruptly at the beginning of the systole. The conventional mechanical tabs, the speed of the main closing of some portions of the tabs (at 70 beats per minute), are in the order of 1.2-1.5 m / seconds, while the highest closing speed is approximately 0.60 m / s. seconds. Fast angular closing speeds create cavitation in heart valves • 10 mechanical prosthetics. This high closing speed increases the intensity of the impact of the tabs with the closure, and in this way, generates acoustic vibrations large enough to cause discomfort in the patient, damage to the blood (embolism), and generates formations of micro bubbles in the blood that can be detected by a transcranial Doppler (HITS-High Intensity Transcranial Signáis). • Thus, conventional mechanical heart valves suffer from various disadvantages. First, the conventional mechanical heart valves fail to provide optimal blood flow characteristics. Later, conventional mechanical heart valves allow blood to pool behind the valve tabs, thereby creating the possibility of blood coagulation in those locations. As well, i * ^ la¡ ^ í ^ ^^.

Conventional mechanical heart valves can not provide optimal opening and closing times (ie, • times that adequately emulate a natural human valve). It has not been possible, on the pin, to reproduce the 5 flow characteristics of a natural valve when a mechanical prosthesis is used. Thus, with the use of conventional mechanical heart valves, embolic incidents and subsequently mortality can be directly or indirectly attached to the valve prosthesis. • 10 Accordingly, there is a need for an improved mechanical heart valve for implantation in a patient that provides improved flow characteristics, decreases blood accumulation behind the tabs, and provides opening and closing behavior more natural. As a consequence, the present invention is directed to an improved mechanical heart valve for surgical implantation in a patient that substantially eliminates one or more of the problems or disadvantages encountered. in the prior art. An object of the present invention is to provide an improved mechanical heart valve for surgical implantation in a patient that provides improved flow characteristics. Another object of the present invention is I, * *** *** * ***** ** * * ***** *. **. aa ^^^ 1a ^ _. a «a _ ^ :. a -« ^. Ia1: a; a ^^ provide an improved mechanical heart valve for surgical implantation in a patient that decreases the • potential for blood coagulation behind the tabs. Another object of the present invention is to provide an improved mechanical heart valve for implantation in a patient that provides improved (ie, more natural) opening and closing behavior. Another object of the present invention is • 10 provide an improved mechanical heart valve for implantation in a patient that provides reduced regurgitation and closure volume to thereby reduce the workload on the heart. Additional features and advantages of The invention will be set forth in the description that follows, and in part will be apparent from the description, or may be learned by practice of the invention. The objects and other advantages of the invention will be realized and obtained by the structure particularly indicated in the description written and the claims of the same as well as the attached drawings. In order to achieve these and other advantages and in accordance with the purpose of the invention, as it is extensively modified and described, an exemplary embodiment refers to a tongue revolving for a prosthetic heart valve that includes a middle portion that has leading and trailing edge surfaces, and inner and outer surfaces that connect • the leading and trailing edge surfaces, wherein the inner surface generally defines a convex curvature 5 from the leading edge surface to the trailing edge surface and the outer surface generally defines a convex curvature near the leading edge surface and a concave curvature near the trailing edge surface, and the first and second portions of wafers • 10 located at opposite ends to the tabs to facilitate the pivoting or rotation of the tongue as it opens and closes. Another exemplary embodiment refers to a rotating tongue for a prosthetic heart valve that closes which includes a middle portion having leading and trailing edge surfaces, and inner and outer surfaces that connect the leading edge surfaces and • exit, where the interior surface generally defines a convex curvature from the edge surface forward to the trailing edge surface and the outer surface generally defines a convex curvature near the leading edge surface a concave curvature near the leading edge surface. The first and second portions of wings are located in opposite ends to the tongue to facilitate the rotation of the tongue, and closure means are included to cause the tongue to rotate into a closed position before reflux • Substantial blood through the heart valve. Yet another exemplary embodiment refers to a mechanical prosthetic heart valve, the valve includes an annular housing having an inner circumferential surface and at least one tongue disposed adjacent the inner circumferential surface and capable of rotating between an open position in what the • Blood can flow through the heart valve and a closed position in which blood is prevented from flowing through the heart valve. The tongue includes a middle portion that has leading and trailing edge surfaces and inner and outer surfaces that connect the front and exit edge surfaces, wherein the interior surface generally defines a convex curvature from the front edge surface to the surface • trailing edge and outer surface generally defines a convex curvature near the edge surface of outlet and a concave curvature near the trailing edge surface. The first and second portions of wings are located at opposite ends to the tabs to facilitate the rotation of the tongue. Another exemplary embodiment refers to a valve of When the prosthetic heart suddenly sags, the valve includes an annular housing having an inner circumferential surface and at least one tongue disposed adjacent to the prosthesis. • inner circumferential surface and is able to rotate between an open position in which blood can flow through the valve of the heart and a closed position in which blood prevents flow through the valve of the heart. The tongue has closure means for causing the tongue to rotate to a closed position prior to substantial reflux of blood through the heart valve. • 10 An additional exemplary embodiment refers to a prosthetic mechanical heart valve that includes an annular housing having an inner circumferential surface and at least one tongue disposed adjacent the inner circumferential surface and is capable of rotating between an open position in which blood can flow through the heart valve and a closed position in which blood prevents flow through the heart valve.

• The tongue includes a middle portion that has leading and trailing edge surfaces and interior surfaces and which connect the leading and trailing edge surfaces, and the first and second portions of wings located at opposite ends to the tongue to facilitate the rotation of the tongue, and first and second pivotal structures of tongues adapted to cooperate with the first and second wings, respectively, to facilitate the rotation of at least one tongue between the open and closed positions. Each of the pivotal first and second tongue structures includes an input projection extending from the inner circumferential surface of the housing and adapted to contact one of the portions of wings in the open and closed positions, and a projection of closure extending from the inner circumferential surface of the housing and adapted to contact one of the wings portion in the closed position, where the closing projection and the input projection are configured and separated from one another to increase the flow velocity near one of the alite portions. Yet another exemplary embodiment relates to a prosthetic mechanical heart valve that includes an annular housing having an inner circumferential surface and defining at least one opening through the annular housing, and at least one tongue disposed adjacent to the inner circumferential surface and able to rotate between an open position in which blood can flow through the heart valve and a closed position in which blood prevents flow through the heart valve. The tongue includes a middle portion and first and second portions of wings located at opposite ends to the tongue to facilitate rotation of the tongue, wherein no portion of the at least one tongue is received within at least one opening • during rotation between the open and closed position to provide increased blood flow about one-fifth of the alite portions. Yet another additional embodiment relates to a prosthetic heart valve of mechanical early closure, the valve includes an annular housing having an inner circumferential surface, and at least one • 10 tongue disposed adjacent to the inner circumferential surface and capable of rotating between an open position in which blood can flow through the heart valve and a closed position in which blood prevents flow through the heart valve . The tongue includes a medium of early closure to create a tendency for the tongue to rotate toward the closed position so that the tongue is substantially closed before the initiation of the tongue. • reflux of blood through the heart valve. A final exemplary modality refers to a prosthetic heart valve of mechanical early closure, the valve includes an annular housing having an inner circumferential surface, and at least one tongue disposed adjacent the inner circumferential surface and capable of rotating between an open position in the which blood can flow through the heart valve and a closed position in which blood prevents flow through the heart valve. The tongue includes • surfaces with complex curvatures to create a tendency for the tongue to rotate toward the closed position so that the tongue is substantially closed before the initiation of blood reflux through the heart valve. It will be understood that both the foregoing general description and the following detailed description are both explanatory and explanatory examples and are intended to provide further explanation of the invention as claimed. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings that are included to provide a further understanding of the invention and constitute a part of this specification, illustrate embodiments of the invention and together with the written description, serve to explain the principles of the invention. • In the drawings: Figure 1 is an elevated isometric view of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with the tabs in the fully open position; Figure 2 is another elevated isometric view of a preferred embodiment of a multi-tailed mechanical heart valve according to the present invention with a? ^^ i | t &j j the tabs in an open position; Figure 3 is the high isometric view of the • Figure 2 according to the present invention with the tabs in the fully closed position; Figure 4 is the elevated isometric view of Figure 2 according to the present invention with the tabs in a partially open position; Figure 5 is a top plan view of a preferred embodiment of a mechanical heart valve of • 10 multiple tabs according to the present invention with the tabs in the fully open position; Figure 6 is a top plan view of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with the tabs in the fully closed position; Figure 7 is a bottom plan view of a preferred embodiment of a mechanical heart valve of • multiple tabs according to the present invention with the tabs in the fully closed position; Figure 8 is a bottom plan view of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with the tabs in the fully open position; Figure 9 is a bottom plan view of a preferred embodiment of a mechanical heart valve of A. It. multiple tabs according to the present invention with the tabs removed; Figure 10 is a top plan view of a preferred embodiment of a 5-tailed mechanical heart valve according to the present invention with the tabs removed; Figure 11 is an isometric view of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with the tabs removed; Figure 12 is an isometric view in partial cross-section taken along line 12 '-12' in Figure 11 of a preferred embodiment of a multi-tabs mechanical heart valve in accordance with present invention with the tabs removed; Figure 13 is an isometric cross-sectional view of the housing of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention; Figure 14 is a side view of a preferred embodiment of a tab of a multi-tabs mechanical heart valve according to the present invention; Figure 15 is an isometric view of a preferred embodiment of a tongue of a heart valve multi-tabs mechanics according to the present invention; Figure 16 is a front view of a modality • preferred one tab of a multi-tabs mechanical heart valve according to the present invention; Figure 17 is a top view of a preferred embodiment of a tab of a multi-tabs mechanical heart valve according to the present invention; Figure 18 is a bottom view of a preferred embodiment of a tab of a multi-tailed mechanical heart valve 10 according to the present invention; Figure 19 is a top plan view of a preferred embodiment of a tab of a multi-tabs mechanical heart valve according to the present invention with three different cross-sectional views included; Figure 20 is a partial cross-sectional view taken along the line 20 '-20' in Figure 17 of the profile of a preferred embodiment of a tongue for a mechanical heart valve of multiple tabs of In accordance with the present invention; Figure 21 is a cross-sectional view taken along line 21 '-21' in Figure 5 of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with the tabs in the fully open position; ..J.- üa.¿ ^ > .

Figure 22 is a cross-sectional view taken along the line 22 '-22' in Figure 6 of a • preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with only one of the tabs shown in the fully closed position; Figure 23 is a cross-sectional view taken along line 21 '-21' in Figure 5 of a preferred embodiment of a mechanical heart valve of • 10 multiple tabs according to the present invention with the tabs removed; Figure 24 is a graphical representation of the performance of a preferred embodiment of a multi-tabs mechanical heart valve in accordance with present invention in the aortic position at three different heart rates; Figure 25 is a graphic representation of the • performance of a preferred embodiment of a multi-tabs mechanical heart valve in accordance with present invention at the mitral position at three different heart rates; and Figure 26 is a cross-sectional view similar to Figure 21 illustrating a preferred embodiment of a stitched ring for a multi-tailed mechanical heart valve according to the present invention. h * í. * 6 **. ** * * Reference will now be made in detail to the preferred embodiments of the present invention, examples of • which are illustrated in the attached drawings. For example, Figure 1 shows an elevated isometric view of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with the tabs in the fully open position so that blood can flow through the valve of blood. As shown in Figure 1, the valve 100 of The mechanical heart of multiple tabs generally includes an annular housing 105 and rotating tabs 110 (as used herein, the term "annular" is taken to encompass any continuous surface). The housing 105 includes inner and outer circumferential surfaces as described in the above (as used herein, the phrase "circumferential surface" is taken to imply the abutting surface of any closed configuration). The housing 105 has three concave portions 115 and three convex portions 120 around its upper surface, as well as six openings 125 in it (called in the present windows) and six projections 130 of input. Note that the input projections 130 extend from the inner circumferential surface of the housing 105 into the path F of blood flow.

The housing 105 can be constructed of any rigid biocompatible material. For example, accommodation • 105 can be constructed of any biocompatible metallic material, such as chromium, nickel-tungsten and titanium. The housing 105 can also be constructed of any rigid biocompatible organic material such as, for example, pyrolytic carbon. In addition, the housing 105 can be constructed from any biocompatible polymeric material, such as a biocompatible plastic material.

• In the preferred embodiment, housing 105 is machined from a solid metal bar. Like the housing 105, the tabs 110 can be constructed of any rigid biocompatible material (metallic, organic or polymeric). In the preferred mode, The tongues 110 are preferably made from pyrolytic carbon. Tabs 110 of the preferred embodiment have two complex non-parallel curved surfaces. Figure 2 shows a high isometric view of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with tabs 110 rotated to an open position. Figure 2 also clearly shows the structure in the housing 105 that facilitates rotation and retains the tabs 110.

Each tongue 110 has two wings 205 (the angled portions of the ends of each of the tabs) with a middle portion disposed therebetween. The wings 205 • rest on the input projections 130 (at least when the tabs are in their closed position). In addition to the five input projections 130, the housing 105 can informatively be compared to the structure described in US Patent No. 5,123,918 which is incorporated herein by reference. As shown in Figure 2, the windows 125 communicate with the blood flow through ^ 10 the heart valve 100 in regions designated 220. In this way, the windows 125 allow blood to flow through the back of the wings 205 and substantially wash the pivotal region of the tongue both in the open position and in the open position. the closed. This washing helps reduce greatly stagnation of the blood behind the wings 205, and thus reduces the likelihood of local blood clot formation or thrombus in this region. Note that windows 125 can be any The size configuration that allows proper structural rigidity in the housing 105 and the optimal wash flow through the windows and into the pivotal region of the tabs. In the preferred embodiment, the windows 125 are triangular in shape. Although the housing 105 can be made of any annular configuration, the housing of the preferred embodiment has three concave portions 115 and three convex portions 120 around the upper surface of the circumference, i.e., a scalloped arrangement. These 5 concave portions 115 and convex portions 120 play a special role during the surgical implantation of the valve prosthesis 100. During implantation, a sewn ring (see Figure 26, for example) is attached to the outer circumference of housing 105. The surgeon • 10 then suture through the tissue and through the sewn ring to join the valve at its desired location. If the surgeon inadvertently places one or more of the sutures around the housing 105, when the sutures are pulled tightly, the geometry of the housing 105 will move the sutures misplaced towards the concave portions 115 instead of the convex portions 120. In this way, there is a small opportunity for a suture to be tied over the • convex portions 120 of the housing 105 and thereby preventing the opening and closing of the tabs 110. Figure 3 is an elevated isometric view of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with the tabs in the fully closed position to prevent blood flow through the heart valve.

As shown, the housing 105 also includes six tab catch projections 300 that help prevent the tabs 110 from being easily removed from their seats. • articulated structures. The effective closing angle of the complex curved tongue can be defined by the chordae of the tongue in its middle section. Note that in the preferred embodiment, the tongue of the tabs 110 preferably closes at an angle of about 30 ° to about 40 ° with respect to the intake plane of the housing 105. With the tabs 110 in the closed position, the The angle or pyramidal configuration of the closed tabs 110 also channels the flow through the windows 125 of the valve housing 105 resulting in improved washing by the flow of blood through the back of the wings. 205 and completely washes the pivotal region of the tongue. Again, this washing helps greatly reduce the blood buildup behind the wings 205, and thus reduces the likelihood of • formation of a local blood clot or thrombus in this region. Figure 4 shows a high isometric view of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with the tabs rotated in a partially open position (50% open - in between between the fully position open and the position completely closed). In this position, as well as any other position in which the tongues 110 are at least partially open, the • blood flows through the posterior surface of the tabs 110 and through the windows 125 to completely flush the pivotal region of the tongue. As mentioned in the above, this washing helps to greatly reduce the accumulation of blood behind the wings 205, and thus reduces the likelihood of a local blood clot or thrombus formation in this region. ^^ 10 Figure 5 is a top plan view and Figure 8 is a bottom plan view of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with the tabs in the fully open position. As shown, the open tabs 110 divide the flow of blood through the valve 100 into several different flow paths. The main flow path 500 extends along the central axis of the valve 100, while the outer flow paths 505 are traced by the open tabs 110. Note, as shown in Figures 1 and 2, that the wings 205 of the tabs 110 do not completely cover the windows 125 when the tabs 110 are in the open position. Thus, in this position, as well as any other open position, 25 blood flows through the windows 125 wash ^^^^^^^^^^^^ * á * & * ¡¡¡¡Completely the pivotal region of the tongue, reducing the possibility of stagnation or coagulation of the blood in this region. Although the open angle of the tabs 110 can be used for different requirements, the tabs of the tabs 110 of the preferred embodiment open at an effective angle of about 75 ° to about 90 ° with respect to the input plane of the housing 105. The open angle Effective of the complex curved tongue can be defined by the chorda of the tongue in its middle section. This open angle, coupled with the unique contour of the tabs, provides a central flow valve, similar to the natural valves of the heart. This results in a reduced pressure gradient or pressure drop across the valve in the open position when compared to most conventional mechanical heart valves. Figure 6 is a top plan view and Figure 7 is a bottom plan view of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with the tabs in the fully closed position. As shown, in the preferred embodiment, the lenses 110 close the outer and main flow paths 500 and 505 respectively. However, in some cases, it may be ^^^^ ^^^^ It is desirable to leave a small space between the tabs in the closed position. It has been discovered that a small space, • while allowing for less static escape, some performance characteristics tend to improve, for example, 5 it reduces the damaging effects of cavitation (by increasing the cavitation threshold) on the exit surfaces of the tabs during closure. This small space does not need to be continuous or constant along the irtersection of the tabs 110. It can be a space which is wider in • 10 the pointed tips of the tabs 110 and become progressively narrower radially towards the housing 105. It is noted that a very small opening between the tabs only near their tips is shown in the figures (due to manufacture). Figure 9 is a bottom plan view and the Figure 10 is a top plan view of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with the tabs 110 removed. This figure illustrates the structure in the housing 105 that facilitates rotation and stops the tabs 110. As shown, this structure includes six input projections 130, three closure projections 200, six wing slip paths 210, six tongue catch projections 300, and six arcs 215 of slip of the wings.

Figure 11 is an isometric view of a preferred embodiment of a mechanical heart valve of • multiple tabs according to the present invention with the tabs removed. As shown, each window 125 is placed just below a slip path 210 of the wings, the slip path 210 of the wings is defined between an input projection 130 and a closure projection 200. Also shown in this Figure is the sewn ring that receives the 1100 portion of the housing • 10 105. Although in the preferred embodiment the sewn ring that receives the portion 1100 is an extended part of the housing 105, other seam-ring joining arrangements can be considered. Figure 12 is an isometric view in section Partial transverse line taken along line 12 '-12' in Figure 11 of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with the tabs removed. As illustrated, the input projection 130 includes a portion 1205 of non-uniform surface. It has been discovered during the test that additional wear resistance can be achieved through the use of this non-uniform asymmetric surface on one side of the input projection 130 as it joins with a complementary seating surface. on each tab 110 (provides the interface contact surface instead of the interface contact point). Figure 13 is a plan view in section Transverse of the housing 105 of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention. Although the different cross sections can be considered, in the preferred embodiment, a converging nozzle is used in cross section. As shown, the housing 105 of the preferred embodiment includes a section 1200 convergent as well as a portion 1100 receiving the sewn ring. In this way, the housing 105 of the preferred embodiment converges in the direction F of flow which decreases flow separation and turbulence on the input side of the valve during flow forward through the valve open. The converging nozzle also reduces the pressure drop or pressure gradient across the valve during forward flow through the open valve when • it is compared to other heart valves that have instead of an abrupt or blunt configuration on the input side of the accommodation. In this way, the housing of the preferred embodiment has improved flow characteristics and decreases the pressure or energy losses and flow separation through the open valve. Figure 14 is a side view of a modality Preferred tab 110 for a multi-tabs mechanical heart valve according to the present invention. The preferred embodiment of the tongue 110 according to the present invention includes an alite 205 on each side of the middle portion of the tongue 110. Figure 15 is an isometric view of a preferred embodiment of a tongue 110 for a mechanical heart valve of multiple tabs according to the present invention. The present invention comprises inner flow surface 1400, outer flow surface 1405, front edge surface 1410, and output edge surface 1415. As mentioned in the foregoing, the tongue 110 includes two portions of alita seating 1500 which join with the input projections 130. As this figure is depicted, the outer surface surface 1405 of the tongue 110 is concave along a line extending between the wings 205. Although the preferred embodiment of a tongue 110 for a mechanical heart valve of multiple tabs of According to the present invention it is somewhat triangular in configuration (because three tabs are used), other configurations and numbers of tabs can be used without departing from the spirit and scope of the present invention. Figure 16 is a front view, Figure 17 is a top view and Figure 18 is a bottom view of a preferred embodiment of a tab 110 for a multi-tabs mechanical heart valve in accordance with • present invention. As shown in these figures, the wings 205 include the outer surface 1600 of the wing and the inner surface 1605 of the wing. The outer surface 1600 of alite is the surface that is washed by the blood flow through the windows 125. As shown in Figure 18, the inner flow surface 1400 of the tongue 110 is convex along a line That • 10 extends between the wings 205. Figure 19 is a top plan view of a preferred embodiment of a tongue 110 for a multi-tabs mechanical heart valve according to the present invention with three views in cross section different included. The section cuts (A, B and C) show the changing cross section of the preferred embodiment of a tongue 110 for a heart valve • multi-tabs mechanics according to the present invention from the central line A-A to the exact average of the wing 205. As can be seen, the section A-A shows a cut of several thicknesses and contours, and the section C-C near the wing 205 showing a cut with a smaller variation in thickness and less pronounced contours. Section B-B shows an intermediate cut that exemplifies the transition A-A and C-C. Preferably, the tongue is symmetrical around section A-A. Figure 20 is a cross-sectional view • partial taken along line 20 '-20' in Figure 17 of the profile of a preferred embodiment of a tab 110 5 for a multi-tabs mechanical heart valve according to the present invention. As shown, the inner flow surface 1400 has a convex curvature from the leading edge surface 1410 to the leading edge surface 1415. The surface 1405 of • The outer flow has an S-shaped curvature from the leading edge surface 1410 to the output surface 1415. The configuration of the preferred embodiment of the tongues 110 decreases the flow separation in the position open and change the early closure of the tabs. As will be appreciated by one skilled in the art of fluid mechanics, the configuration of the tongue 110 affects the ^ distribution of the pressure on its surface as blood flows around it. As shown Figure 20, the tab 110 according to the present invention has a virtual pivotal axis approximate in a location shown in 2000. Thus, during the operation the pressure distribution on the tongue will affect the rotational tendency of the tongue around the axis 2000 virtual pivotal.

Given the interior and exterior flow surfaces, the differences between the surface pressure • static along the inner flow surface Pi and the outer flow surface Po and in view of the location of the virtual pivotal axis at a location shown approximately in 2000, the tongue 110 is caused to tend toward the rotation to the position closed. These pressure differentials are created by the configuration similar to an aerodynamic surface of the tongue 110 in • 10 the flow direction F. The mechanics of fluids (including pressure gradients thereof during flow) of a dynamic air surface are well known to those in the fluid mechanics art. The early closure of the mechanical heart valve according to a modality Preferred of the present invention as the flow F through the valve 100 decelerates, and the pressure field reverses. In the aortic portion, the tabs 110 close substantially before the flow reverses, similar to the function of a natural aortic valve. In another aspect, the inner and outer flow surfaces 1400 and 1405, respectively, are advantageously designed so that in the fully open position and the tabs, the surface tangents of both flow surfaces on the exit surface 1415 and the outer flow surface 1405 on the leading edge surface 1410 are aligned substantially in the flow direction F to limit the flow separation in 9 the swirling (turbulence) formation as the blood flow leaves the trailing edge surface 1405 of the 5 tabs 110 open. According to a preferred embodiment of the present invention, the tangent of the inner flow surface 1400 near the front edge surface 1410 of the tongue 110 forms an angle of preferably about 0 ° to about 30 ° with • 10 regarding the direction of flow. In this way, the flow separation on both inner and outer surfaces 1400 and 1405, respectively, of the tongue 110 is decreased. Accordingly, the tabs 110 of the mechanical heart valve 100 according to the present invention reduce the turbulence, the flow separation, and the energy losses associated with the flow through the open valve. • Figure 21 is a cross-sectional view taken along line 21 '-21' in Figure 5 of a The preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with the tabs 110 in the fully open position. Figure 21 clearly illustrates the interaction of the wings 205 with the slip paths 210 of the wings and the wings. arches 215 slip wings. Also, this *** ^ **. j * í *,, nimi, iá?: - ******. *** - **.

Figure shows that the distance between the input projections 130 and the closing projection 200 decreases in the direction of blood flow. Thus, the wing slip paths 210 create a nozzle effect to direct blood flow through the windows 125 to substantially wash the back surface of the wings 205 to decrease stagnation. Figure 22 is a cross-sectional view taken along the line 22 '-22' in Figure 6 of a • Preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with only one of the tabs 110 shown in the fully closed position. As shown, when in the closed position, the tongue 110 rests on the input projections 130 and closing projection 200. Also illustrated in this Figure are the tab catch projections 300 to help retain the tab 110 in • housing 105. Figure 23 is a cross-sectional view taken along the line 21 '-21' in Figure 5 of a preferred embodiment of a multi-tabs mechanical heart valve according to the present invention with the tabs 110 removed. Similar to Figure 21, this Figure shows that the distance between the projections 130 of and the closing projection 200 decreases in the direction of blood flow due to the wide configuration of the projections 130, 200. Thus, the rewinding trajectories 210 of the wings as nozzles to direct blood flow through the blood. of the windows 125. This nozzle creates increased flow velocity in and around the windows 125 and the slip arches 215 of the wings. This Figure also shows the polished and aerodynamic sculpturing of the intake projections 130 and the closure projection 200 in the direction of blood flow. These aerodynamic profiles help limit blood separation and swirling (turbulence) as blood flows through these elements. Figures 24 and 25 are graphical representations of the performance of a preferred embodiment of a multi-tailed mechanical heart valve according to the present invention at the aortic and mitral positions, respectively at three different heart rates (50, 70 and 120 beats per minute). minute). As shown in Figure 24 in the aortic position, the preferred embodiment of a multi-tailed mechanical heart valve begins to close very early. In f as illustrated, the closure begins just after the peak flow (as the flow slows and the pressure field reverses) and the tabs of the valve close substantially before ^ ¡^ ^ ^^^ i »^^^ * i. i reverse the flow (at V = 0), similar to the natural function of a natural aortic valve. This closing time • early is made possible by the flow charristics of the preferred valve housing 105 as well as the 5 preferred tabs 110 tending toward closure due to its novel geometry. This closing behavior differs dramatically from that of conventional mechanical valve prostheses. As mentioned in the above, in valve prostheses • 10 conventional mechanics at the moment when the flow velocity becomes zero through the valve, the conventional mechanical valve prosthesis remains open 90%. Thus, with the conventional mechanical valve prosthesis, a significant portion of the closure (more than 90%) occurs during the regurgitation (reflux) of the blood through the valve, and thus the closure is very fast and involves a large amount of dynamic escape (regurgitation). A) Yes, • this very fast closing under reflux at high pressure can lead to numerous undesirable results (cavitation, HITS, and unnecessary tension in the heart muscle). In contrast, the preferred embodiment of a multi-tailed mechanical heart valve according to the present invention begins to close just after the peak flow (as the flow slows and the pressure field reverse) and the tabs on the valve close ^^^^^ r-ffli f ^ ñt ^ ^ iift ^^^^^^^^^^^^^^^ substantially (approximately 90%) before the flow reverses (at V = 0) . Thus, the preferred embodiment of a multi-tailed mechanical heart valve according to the present invention begins to close soon and begins to close very slowly. Because the tabs are almost completely closed prior to the initiation of high pressure reflux, the preferred embodiment of a multi-tabs mechanical heart valve according to the present invention reduces the likelihood of cavitation, HITS, heart plot and regurgitation. . Of course, it should be understood that the closing performance of the present invention can be adjusted to meet the desired criteria, such as a desired closure percentage at zero flow rate (initiation of reflux), or timing the initiation of closing rotation with respect to the maximum flow velocity. Preferred adjustments to the design may include modifying the aerofoil geometry of the tabs 110 to affect the pressure distributions along the interior and exterior flow surfaces 1400 and 1405, respectively, a structural modification to the pivotal structure to return to locate the virtual pivotal point of the tongue, a reconfiguration of the tongue to alter its center of mass or its neutral point, etc. The present invention conceives that the closing performance of the valve t * *** ***? ***** _ ^ _ ^ _ * _ ^ A * _ £ _ ^ _ optimal between 50% a > 90% closure before the flow reverses. • Finally, Figure 26 is a cross-sectional view similar to Figure 21 illustrating a preferred embodiment of a sewn-in ring for a multi-tailed mechanical heart valve (in the aortic position) according to the present invention. As shown, this preferred stitched ring is attached to the outer circumference of the housing in the stitched ring that receives the portion 1100. As illustrated in the detailed description, the improved mechanical heart valve for implantation in a patient in accordance with the present invention substantially eliminates one or more of the problems or disadvantages found in the prior art. The novel structure, as is particularly pointed out in the written description and the accompanying drawings thereof, provides a '* W mechanical heart valve improved for implantation in a patient that provides flow characteristics improves, decreases the coagulation of blood behind the tabs, and provides more natural closing and opening behavior. It will be apparent to those skilled in the art that various variations and modifications can be made in the mechanical heart valve for implantation in a patient of the present invention without departing from the spirit or scope of the present invention. Thus, it is intended that the present invention cover the modifications and variations of this invention with the proviso that they fall within the scope of the description thereof and any equivalents of the structures described therein. • * k '*. * i *?

Claims (59)

1. CLAIMS 1. A rotating tongue for a valve Prosthetic heart characterized in that it comprises: a middle portion including leading and trailing edge surfaces 5, and inner and outer surfaces connecting the leading and trailing edge surfaces, wherein the inner surface generally defines a convex curvature from the surface from leading edge to the trailing edge surface and the surface • Outside generally defines a convex curvature near the leading edge surface and a concave curvature near the trailing edge surface, and first and second portions of wafers located at opposite ends to the tab to facilitate rotation of the trailing edge. the tongue 2. The revolving tongue according to claim 1, characterized in that the inner surface • has a convex curvature from the first portion of the alite to the second portion of the alite. 3. The rotary tongue according to claim 1, characterized in that the outer surface has a concave curvature from the first portion of the wing to the second portion of the wing. 4. The revolving tongue in accordance with the 25 claim 1, 2, or 3, characterized in that the distance ttsá *. The tab between the inner and outer surfaces is closer to the leading edge surface than the distance between the inner and outer surfaces near the trailing edge surface so that the tab has a cross-sectional airfoil section. 5. The rotary tongue according to claim 1, characterized in that the tongue is formed from pyrolytic carbon. 6. The revolving tongue in accordance with the • 10 claim 4, characterized in that the tongue is formed from pyrolytic carbon. The rotary tongue according to claim 1, characterized in that each portion of the wing is joined to the inner and outer surfaces and to the leading and trailing edge surfaces. 8. A rotating tongue for an early-closure prosthetic heart valve characterized by • comprises: a middle portion including leading and trailing edge surfaces 20, and inner and outer surfaces connecting the leading and trailing edge surfaces, first and second wart potions located at opposite ends to the tab for easy rotation of the tongue; and 25 closure means for causing the tab to rotate to a closed position prior to substantial reflux of blood through the heart valve. 9. The rotary tongue according to claim 8, characterized in that the closing means 5 causes the tab to begin to rotate to a closed position approximately when the maximum flow velocity has been achieved through the valve. The rotary tongue according to claim 8, characterized in that the closing means • 10 comprises a configuration where the inner surface has a convex curvature from the leading edge surface to the trailing edge surface and the outer surface has a convex curvature near the leading edge surface and a concave curvature near 15 of the trailing edge surface. 11. The rotary tongue according to claim 10, characterized in that the closing means • also comprises a configuration where the distance between the inner and outer surfaces is closer to the 20 front edge surface than the distance between the inner and outer surfaces near the trailing edge surface so that the tab has a cross-sectional section of the airfoil. 12. The rotating tongue in accordance with the 25 claim 10, characterized in that the surface The interior has a concave curvature from the first portion of the alite to the second portion of the alite. • 13. The rotating tongue according to claim 12, characterized in that the outer surface 5 has a concave curvature from the first portion of the alite to the second portion of the alite. 14. The rotary tongue according to claim 8 or 11, characterized in that the tongue is formed from pyrolytic carbon. # 10 15. A mechanical prosthetic heart valve, the valve is characterized in that it comprises: an annular housing having an inner circumferential surface; and at least one tab disposed adjacent the inner circumferential surface and capable of rotating between an open position in which blood can flow through the heart valve and a closed position in which the • blood is prevented from flowing through the heart valve, the tab comprises: a middle portion including leading and trailing edge surfaces, and inner and outer surfaces connecting the leading and trailing edge surfaces, wherein the inner surface generally defines a convex curvature from the leading edge surface 25 to the trailing edge surface and the surface i. *. * *, ** i A? The exterior generally defines a convex curvature near the leading edge surface and a concave curvature • near the trailing edge surface; and first and second portions of a Litas located in 5 opposite ends to the tab to facilitate the rotation of the tongue. 16. The prosthetic mechanical heart valve according to claim 15, characterized in that the annular housing comprises a nozzle configuration as • 10 length of the interior circumference surface. 17. The mechanical prosthetic heart valve according to claim 15, characterized in that the inner circumferential surface includes input projections for receiving the tongue. 18. The prosthetic mechanical heart valve according to claim 15, characterized in that the inner surface of at least one tongue has a • convex curvature from the first alite portion to the second alveal portion 20 19. The mechanical prosthetic heart valve according to claim 18, characterized in that the outer surface of at least one tongue has a concave curvature from the first portion. from alita to the second portion of alita. 20. The prosthetic mechanical heart valve according to claim 15, 18, or 19, characterized in that the distance between the inner and outer surfaces of at least one tongue is closer to the leading edge surface than the distance between the inner and outer surfaces near the trailing edge surface so that at least one tab has a cross-sectional section of aerodynamic surface. 21. The mechanical prosthetic heart valve according to claim 15, characterized in that it also comprises at least two tongues. 22. The mechanical prosthetic heart valve according to claim 21, characterized in that it also comprises at least three tabs. 23. The mechanical prosthetic heart valve according to claim 15, characterized in that the valve housing is formed from a metallic material. 24. The mechanical prosthetic heart valve according to claim 15, characterized in that at least one tongue is formed from pyrolytic carbon. 25. A prosthetic heart valve of mechanical early closure characterized in that it comprises: an annular housing having an inner circumferential surface; and at least one tongue disposed adjacent to the inner circumferential surface and capable of rotating between • an open position in which blood can flow through the heart valve and a closed position in which the blood is prevented from flowing through the heart valve, the tongue comprising closure means to cause the tongue turn to a closed position before substantial reflux of blood through the heart valve. 26. The mechanical prosthetic heart valve • 10 according to claim 25, characterized in that the closing means causes the tongue to begin to rotate towards a closed position approximately when the maximum flow velocity has been achieved through the valve. 27. The mechanical prosthetic heart valve according to claim 25, characterized in that at least one tongue comprises: a middle portion including leading and trailing edge surfaces, and inner and outer surfaces 20 connecting the leading and trailing edge surfaces, and first and second waxy potions located at opposite ends to at least one tongue to facilitate rotation of the tongue. 28. The prosthetic mechanical heart valve according to claim 27, characterized in that the closure means comprises a configuration where the • inner surface generally defines a convex curvature from the leading edge surface to the trailing edge surface and the outer surface generally defines a convex curvature near the leading edge surface and a concave curvature near the trailing edge surface . 29. Mechanical prosthetic heart valve • 10 according to claim 28, characterized in that the closure means further comprises a configuration wherein the distance between the inner and outer surfaces of the at least one tongue is closer to the leading edge surface than the distance between the inner surfaces. and outer near the trailing edge surface so that the tab has a cross-sectional section of the aerofoil. • 30. A mechanical prosthetic heart valve, characterized in that it comprises: an annular housing that has; an inner circumferential surface; and at least one tongue disposed adjacent to the inner circumferential surface and capable of rotating between an open position in which blood can flow through 25 of the heart valve and a closed position in which the blood is prevented from flowing through the heart valve, and at least one tab that includes a middle portion that • includes leading and trailing edge surfaces, and the inner and outer surfaces connecting the leading and trailing edge surfaces, and the first and second wafer portions located at opposite ends of at least one tongue to facilitate rotation of at least one tongue; and first and second pivot tongue structures '"*' 10 adapted to cooperate with the first and second wings, respectively, to facilitate rotation of at least one tongue between the open and closed positions, each of the first and second pivotal structures. second tab comprises: an input projection extending from the inner circumferential surface of the housing and adapted to contact one of the portions of • wings in one of the open and closed positions; and a closing projection that extends from the 20 inner circumferential surface of the housing and adapted to make contact with one of the wings portion in the closed position, wherein the closing projection and the input projection are configured and separated from each other to increase the flow rate 25 near one of the wings portions. 31. The mechanical prosthetic heart valve according to claim 30, characterized in that • each input projection has a first width near the inner surface of the annular housing, and a 5 second distal width of the inner surface of the valve housing less than the first width. 32. The mechanical prosthetic heart valve according to claim 30, characterized in that each input projection has a first width close to ^^ 10 to the inner surface of the annular housing, and a second distal width of the inner surface of the valve housing less than the first width. 33. The mechanical prosthetic heart valve according to claim 30, characterized in that the The annular housing defines at least one opening therethrough close to the input and closing projections. • 34. The mechanical prosthetic heart valve according to claim 33, characterized in that the The distance between the input projection and the closure projection decreases in the direction of blood flow to direct at least a portion of the blood flow through at least one opening when at least one tab is in the direction of flow. open position 25 35. The mechanical prosthetic heart valve g * ^ B¡aag * Ba ^^ according to claim 30, characterized in that the inner surface of at least one generally • defines a convex curvature from the leading edge surface to the trailing edge surface and the outer surface of at least one lencfuette generally defines a convex curvature near the leading edge surface and a concave curvature near the trailing surface. trailing edge. 36. The prosthetic mechanical heart valve of f 10 according to claim 35, characterized in that the distance between the inner and outer surfaces is closer to the leading edge surface than the distance between the inner and outer surfaces near the surface of outlet edge so that at least one tab has a cross-sectional section of aerofoil. 37. A mechanical prosthetic heart valve, characterized in that it comprises: an annular housing having an inner circumferential surface and defining at least one opening through the circumferential surface; and at least one tongue disposed adjacent to the inner circumferential surface and capable of rotating between an open position in which blood can flow through 25 of the heart valve and a closed position in which the blood is prevented from flowing through the heart valve, and at least one tongue comprising a middle portion and first and second portions of wings located at opposite ends of the heart valve. tongue to facilitate tongue rotation, wherein no portion of at least one tongue is received within at least one opening during rotation between the open and closed position to provide an increased blood flow near one of the portions of wings. 38. The mechanical prosthetic heart valve according to claim 35, characterized in that the annular valve housing includes first and second pivotal structures of tabs adapted to cooperate with the first and second wings, respectively, to facilitate rotation of at least a tongue between the open and closed positions, each of the first and second pivotal tongue structures comprise: an input projection extending from the inner circumferential surface of the housing and adapted to contact one of the portions of wings in one of the open and closed positions; and a closure projection extending from the inner circumferential surface of the housing and adapted to make contact with one of the alite portions in the closed position, wherein the closing projection and the intake projection are configured and separated from each other to direct the flow through so • less an opening through the circumference surface. 39. The mechanical prosthetic heart valve according to claim 37, characterized in that the medial portion of the at least one tongue includes leading and distal edge surfaces, and inner and outer surfaces that connect the leading and trailing edge surfaces. exit, and where the interior surface • 10 generally defines a convex curvature from the leading edge surface to the trailing edge surface and the outer surface generally defines a convex curvature near the leading edge surface and a concave curvature close to the trailing edge surface. 15 departure. 40. The mechanical prosthetic heart valve according to claim 39, characterized in that the • distance between the inner and outer surfaces is closer to the surface of the front edge than the The distance between the outer inner surfaces near the trailing edge surface so that at least one tab has a cross-sectional airfoil section. 41. The prosthetic mechanical heart valve according to claim 39, characterized in that at least one opening through the circumferential surface is close to the closing projections and • opening. 42. The mechanical prosthetic heart valve according to claim 39, characterized in that the annular valve housing is formed from a metallic material. 43. The mechanical prosthetic heart valve according to claim 39, characterized in that • At least one tongue is formed from pyrolytic carbon. 44. A prosthetic heart valve with mechanical early closure, characterized in that the valve comprises: an annular housing having an inner circumferential surface; and at least one tongue disposed adjacent to the inner circumferential surface and capable of rotating between an open position in which blood can flow through 20 of the heart valve and a closed position in which blood is prevented from flowing through the heart valve, at least one tab comprises early closing means to create a tendency for the tab to rotate to a closed position before of the initiation of the reflux of the 25 blood through the heart valve. ^^^ ^^^^^^ & ^^^^^^^^^^ 45. The prosthetic heart valve mechanical early closure according to claim 44, characterized in that at least one tongue is closed more than 50% before the initiation of reflux of blood through the heart valve. 46. The mechanical prosthetic heart valve of early mechanical closure according to claim 45, characterized in that at least one tongue is closed more than 60% before the initiation of the reflux of blood through the heart valve. 47. The prosthetic heart valve of mechanical early closure according to claim 46, characterized in that at least one tongue closes more than 70% before the initiation of the reflux of the blood through the heart valve. 48. The mechanical prosthetic heart valve of early mechanical closure according to claim 47, characterized in that at least one tongue closes more than 80% before the initiation of the reflux of the blood through the heart valve. 49. The prosthetic heart valve of mechanical early closure according to claim 48, characterized in that at least one tongue closes more than 90% before the initiation of the reflux of the blood through the heart valve. .. * * * i * ^ h? SÉfflltí.tá imt ******* ***. ** - * -? * - * * i. ** *****. *. . * * *. ** . * ^ ********* i ****. ** h ***. ** ***** * f ** h * ** - **. ***. . < t **. ** S. - -l *, *, ** * :, -8 * to a * * *********** * * 50. The prosthetic heart valve of mechanical early closure according to claim 46, characterized in that at least one tongue further comprises: a middle portion including leading and trailing edge surfaces, and inner and outer surfaces connecting the leading and trailing edge surfaces, and first and second portions of wings located in • 10 opposite ends of at least one tongue to facilitate rotation of at least one tongue, each of the wing portions has a first side near the annular valve housing and a second side opposite thereto. 51. The prosthetic heart valve with mechanical early closure according to claim 50, characterized in that the early closing means comprise • a configuration wherein the inner surface of at least one tongue has a convex curvature from the 20 front edge surface to the trailing edge surface and the outer surface has a convex curvature near the leading edge surface and a concave curvature near the trailing edge surface. 52. The closing prosthetic heart valve 25 early mechanics according to claim 51, *. . - ****. * -i * characterized in that the early closure means comprises a configuration in which the distance between the surfaces • interior and exterior of at least one tongue is closer to the front edge surface than the distance 5 between the inner and outer surfaces near the trailing edge surface so that at least one tongue has a cross section of the aerodynamic surface. 53. The closing prosthetic heart valve • Early mechanical device according to claim 50, characterized in that at least one opening through the annular housing is provided to allow the flow of blood through the first side of at least one of the portions of wings when at least a tongue is in 15 the open position. 54. A prosthetic heart valve of mechanical early closure, characterized in that it comprises: • an annular housing having an inner circumferential surface; and at least one tongue disposed adjacent the inner circumferential surface and capable of rotating between an open position in which blood can flow through the heart valve and a closed position in which blood is prevented from flowing through. of the heart valve, for At least one tongue comprises surfaces with complex curvatures to create a tendency for at least one tongue to rotate toward the closed position so that at least one tongue closes substantially before the initiation of blood reflux through the valve from the heart The prosthetic heart valve of mechanical early closure according to claim 54, characterized in that surfaces with complex curvatures cause at least one tongue to begin to rotate towards a closed position approximately when a maximum flow velocity has been reached. achieved through the valve. 56. The prosthetic heart valve of mechanical early closure according to claim 54, characterized in that at least one tongue further comprises: a middle portion that includes front and exit edge surfaces, and interior and exterior surfaces that connect the front and exit edge surfaces; • and first and second portions of aiites located at opposite ends of at least one tab to facilitate rotation of at least one tab, each of the portions of wings has a first side near the annular valve housing and a second side opposite to it. 25 57. The closing prosthetic heart valve i? * & -a, -i a »ak *. Mechanical early in accordance with claim 56, characterized in that the complex curvatures comprise a • configuration wherein the inner surface of at least one tongue has a convex curvature from the leading edge surface 5 to the trailing edge surface and the outer surface has a convex curvature near the leading edge surface and a concave curvature near the trailing edge surface. 58. The closing prosthetic heart valve 10 according to claim 57, characterized in that the complex curvatures comprise a configuration wherein the distance between the inner and outer surfaces of at least one tongue is closer to the leading edge surface than the distance 15 between the inner and outer surfaces near the trailing edge surface so that at least one tab has a cross-sectional section of the trailing edge. • aerodynamic surface. 59. The closing prosthetic heart valve 20 according to claim 56, characterized in that at least one opening through the annular housing is provided to allow the flow of blood through the first side of at least one of the portions of wings when at least one tongue is in 25 the open position. agj ^ ¡^ aa ^^ gj ^ gffijjtegogy ^^^^^^ a ^ a ^^^^ Ma ^^. ^^ aa ^ i ^^^^^^^ a ^^