Valve prostheses and methods for manufacturing and using valve prostheses

Abstract

The present invention relates to an atrioventricular valve prosthesis that can be implanted in, for example, the heart of a mammal. The heart valve prosthesis comprises a foldable and expandable tubular stent having a lumen, the lumen having, preferably during use of the stent or when fully expanded, an opening cross-sectional area or opening area smaller than the opening area of ​​the natural atrioventricular valve replaced by the heart valve prosthesis. The heart valve prosthesis further comprises an internal valve leaflet positioned within the lumen of the tubular stent that closes the heart valve by abutting against each other, an external valve leaflet that closes against the natural valve leaflet, and at least one fixation suture directly or indirectly connected to the tubular stent. The present invention further relates to a method for manufacturing a heart valve prosthesis and a method for inserting a heart valve prosthesis.

Description

Technical Field

[0001] The present invention relates to an artificial valve, particularly an artificial valve for implantation into the heart, more particularly for implantation by a minimally invasive or percutaneous method. More specifically, the present invention relates to a heart valve prosthesis configured to be suitable for replacement of a mammalian heart valve, more specifically an atrio-ventricular heart valve, a mitral valve, a bicuspid valve, and / or a tricuspid valve. The present invention further relates to a method for manufacturing a heart valve prosthesis according to claim 21, and a method for inserting, implanting, and / or fixing a heart valve prosthesis according to claim 25.

Summary of the Invention

Problems to be Solved by the Invention

[0002] The object of the present invention is to specify yet another heart valve prosthesis, a method for manufacturing a heart valve prosthesis, and a method for inserting, implanting, and / or fixing a heart valve prosthesis.

Means for Solving the Problems

[0003] A heart valve prosthesis according to the present invention, preferably an atrio-ventricular valve prosthesis, is designed, constructed, and / or adapted to be implantable in a mammalian heart.

[0004] The heart valve prosthesis according to the present invention comprises at least one, preferably collapsible-expandable, tubular stent having a lumen. The lumen preferably has an opening cross-sectional area or opening area that is smaller, for example, than the opening area of a native heart valve replaced by the heart valve prosthesis, during use of the stent or in a fully expanded state, such as the opening area of a mammalian atrio-ventricular valve.

[0005] The cardiac valve prosthesis according to the present invention further comprises at least one, two, preferably three or four internal valve leaflets or lobes positioned within the lumen of a tubular stent and closing the valve by contacting each other. The internal valve leaflets or lobes can be configured, particularly in the implanted state, to close the cardiac valve during systole and to open the cardiac valve during diastole, for example by being pushed aside, thereby allowing blood flow, for example, from the atrium to the ventricle. The internal valve leaflets or lobes are preferably positioned at or near the proximal opening of the tubular stent. The proximal opening can be one of two openings at the end of the tubular stent. The internal valve leaflets may not be opened to allow blood flow through the proximal opening of the tubular stent during systole and diastole, but instead may be configured as a foldable structure that blocks blood flow in both directions through the proximal opening within the stent.

[0006] The heart valve prosthesis according to the present invention further comprises at least one, two, preferably three or four fixation threads, which may be directly or indirectly connected to a tubular stent, for example, by the first end or free end of each thread, or may be an integral part of the tubular stent. The fixation threads may preferably be connected to the tubular stent before implantation, for example to the outer surface of the tubular stent, preferably in a non-separable manner, and / or remain connected to the tubular stent during use of the valve prosthesis after implantation.

[0007] A method according to the present invention for manufacturing a heart valve prosthesis, and more particularly for manufacturing a heart valve prosthesis, includes or encompasses at least the step of preparing a preferably foldable and expandable tubular stent having a lumen. The lumen of the tubular stent preferably has an opening cross-sectional area or opening area smaller than the opening area of, for example, a natural heart valve in a mammal, such as a natural atrioventricular valve, which is preferably replaced by the heart valve prosthesis during use or when the tubular stent is fully expanded.

[0008] A method according to the present invention for manufacturing a cardiac valve prosthesis further includes or encompasses the steps of positioning, securely fixing, and / or attaching, for example, suture and / or binding, at least one, two, preferably three or four internal valve leaflets or lobes within the lumen of a tubular stent. The internal valve leaflets or lobes may be configured, particularly in the implanted state, to close the cardiac valve during systole and to open the cardiac valve during diastole, for example by being pushed aside, thereby allowing blood flow, for example, from the atrium to the ventricle. The internal valve leaflets may, instead of being opened during systole and diastole to allow blood flow through the proximal opening of the tubular stent, be configured as foldable structures that block blood flow in both directions through the proximal opening within the stent.

[0009] A method according to the present invention for manufacturing a heart valve prosthesis further includes or encompasses the step of providing at least one, two, preferably three or four fixation threads. The fixation threads can be directly or indirectly connected to a tubular stent, for example, by the first end or free end of each thread, or can be an integral part of the tubular stent. The fixation threads may be connected to the tubular stent in a way that makes them inseparable and / or that they remain connected during use of the valve prosthesis after implantation.

[0010] A method according to the present invention for inserting, implanting, and / or fixing a heart valve prosthesis, particularly for inserting, implanting, and / or fixing a heart valve prosthesis, and / or for inserting, implanting, and / or fixing a heart valve prosthesis manufactured according to a manufacturing method according to the present invention, comprises or includes at least the step of preparing and / or manufacturing at least one heart valve prosthesis, particularly a heart valve prosthesis according to the present invention.

[0011] A method for inserting, implanting, and / or fixing a heart valve prosthesis according to the present invention further includes or encompasses the step of leading the heart valve prosthesis to the right atrium of the heart so as to position the heart valve prosthesis within the opening of the original heart valve to be replaced, for example, within the opening of the original tricuspid valve or mitral valve.

[0012] A method for inserting, implanting, and / or fixing a heart valve prosthesis according to the present invention further includes or encompasses the step of passing the heart valve prosthesis through an intra-atrial septum, for example, a perforation in the septum located between the left and right atria, so that the heart valve prosthesis is positioned, for example, within the opening of the original heart valve to be replaced, for example, within the opening of the original mitral valve.

[0013] Embodiments of the present invention may include some, some, or all of the following features in any combination, unless a person skilled in the art would recognize that such combination is technically impossible.

[0014] In all the following descriptions, expressions such as "can have" or "can have" should be understood as synonymous with "preferably has" or "preferably possess," respectively, and are intended to illustrate embodiments of the present invention.

[0015] Whenever numerical expressions are referred to herein, a person skilled in the art will recognize or understand them as indicating a lower limit of a number. Unless it leads a person skilled in the art to a clear contradiction, a person skilled in the art will understand, for example, that the expression “one” (and “a / an”) includes “at least one.” This understanding is equally encompassed by the present invention as an interpretation that a numerical expression, for example, “one” (and “a / an”), may alternatively mean “exactly one” if it is clearly technically possible to a person skilled in the art. Both understandings are encompassed by the present invention and apply herein to all numerical expressions used.

[0016] For example, whenever spatial information such as “top,” “bottom,” “left,” or “right” is referred to herein, a person skilled in the art will understand that this means the arrangement in the drawings attached herein and / or in use. “Bottom” is closer to the center of the Earth or the bottom of the figure than “top.”

[0017] The terms “proximal” (derived from the Latin “proximus” meaning “closest”) and “distal” (derived from the Latin “distare” meaning “away from”) are used herein to describe parts or locations that are close to or far from the main body. The “proximal end” of a heart valve prosthesis is defined herein as the end of the tubular stent to which the internal valve leaflets are connected or attached. The opposite end of the stent is referred herein as the “distal end” of the heart valve prosthesis. For a more detailed explanation, see the descriptions in Figures 1 and 5.

[0018] Advantageous developments of the present invention are the subject matter of the dependent claims and embodiments.

[0019] Whenever an embodiment is referred to herein, it is an exemplary embodiment of the present invention and should not be understood as limiting.

[0020] Where the subject matter of the present invention is disclosed herein to include one or more features in a particular embodiment, it is also disclosed herein, for example, as an exclusion, that the subject matter of the present invention may likewise not expressly include these features or these features in other embodiments of the present invention. Accordingly, for any embodiment referred to herein, its opposite embodiment, for example expressed in negative form, is also disclosed.

[0021] When the terms "to be programmed" or "to be configured" are used herein, these terms may be synonymous in some embodiments.

[0022] In some embodiments, the heart valve prosthesis is configured to be releasably bent or crimped for delivery to the intended implantation site.

[0023] In some embodiments of the heart valve prosthesis according to the present invention, at least one, preferably a plurality of fixation threads, after implanting the heart valve prosthesis into the mitral valve of the left atrium, are fixed, tied, or have a length sufficient to maintain their state at a position outside the left atrium, such as the atrial septum, preferably the superior vena cava, or more preferably the more proximal jugular vein, or after implanting the heart valve prosthesis into the tricuspid valve of the right atrium, are fixed, tied, or have a length sufficient to maintain their state at a position outside the right atrium, preferably the superior vena cava, or more preferably the more proximal jugular vein.

[0024] In some embodiments, the heart valve prosthesis preferably comprises at least one or more eyelets, or other parts, which are part of a tubular stent or are directly or indirectly attached to the tubular stent, and these eyelets or other parts are for connecting and / or attaching at least one fixation thread to the tubular stent, or are connected and / or attached to at least one fixation thread. At least one or more eyelets, or other parts, preferably do not contribute to the foldable and expandable properties of the tubular stent.

[0025] In some embodiments, the eyelet is connected to a preferably proximal, outer or inner part of the tubular stent, preferably to the periphery of the tubular stent.

[0026] In some embodiments of the heart valve prosthesis, the fixation thread is directly or indirectly connected and / or attached to the eyelet in an optionally separable or non-separable manner.

[0027] In some embodiments, the heart valve prosthesis according to the present invention further comprises external valve leaflets or cusps that are disposed, attached, and / or securely fixed to the outer surface of a tubular stent.

[0028] The heart valve prosthesis may comprise at least one, two, preferably three, up to six external valve leaflets. The external valve leaflets are preferably disposed in proximity to the proximal opening of the tubular stent and are configured to close the valve against native tissue, preferably against the leaflets of the native atrioventricular valve, for example, against the posterior and / or anterior leaflets of the mitral valve. In particular, they may be provided or configured to close the valve in an implanted state and / or during systole. The external valve leaflets may be further provided or configured to be open and allow blood flow from the left atrium to the left ventricle, for example, in an implanted state and / or during diastole.

[0029] In some embodiments, the external valve leaflets are formed by a disk or flange of a material having a round shape, which is round and preferably a frustum of a cone having a central through-opening. Thus, this shape may also be referred to as a cone in this specification.

[0030] In some embodiments, a part of any of the disk-shaped part, flange-shaped part or conical part, particularly a part of the outer periphery of any of the disk-shaped part, flange-shaped part or conical part, and / or a part of the periphery of the through-opening is attached to the tubular stent, particularly to the outside or outer surface of the tubular stent, for example, to its mesh, for example, by being sewn. A part of the periphery of the through-opening can preferably be attached to the proximal end of the tubular stent. A part of the outer periphery of the disk-shaped part can preferably be attached to the tubular stent below the proximal end of the tubular stent, preferably at a predetermined distance therefrom, for example, at its distal end, and / or at any other arbitrary part between them, or at their positions along the tubular stent.

[0031] In some embodiments, the heart valve prosthesis further comprises at least one or more distal anchors, preferably distal to the tubular stent, more preferably connected to its distal end, or being part of the tubular stent.

[0032] In some embodiments, the tubular stent has exclusively one, at least one, or more, preferably distal anchors.

[0033] In some embodiments, the distal anchors are preferably uniformly or non-uniformly distributed along the periphery of the distal end or end portion of the tubular stent, or along a portion of the periphery of the distal end of the tubular stent, for example, along only half, one-third, or one-quarter of the periphery.

[0034] In some embodiments, the tubular stent does not have distal and / or proximal anchors, and in particular, does not have anchors that directly or indirectly fix the heart valve prosthesis to the tissue of the original heart valve being replaced.

[0035] In some embodiments, the anchor has a first end and a second end, the first end being connected to a tubular stent, and the second end being a free end opposite to the first end.

[0036] In some embodiments, at least one anchor is constructed and / or configured to swing radially outward at its free end.

[0037] In some embodiments, at least one, some, or all of the above preferably distal anchors are positioned such that, when subjected to compression, force, or pressure, for example by the sheath, the angle between the distal anchor and the tubular stent is less than a right angle with respect to the longitudinal axis A of the tubular stent, preferably 5° to 90°, more preferably 10° to 30°.

[0038] In some embodiments, most or all of the fixation threads in the anchors and / or eyelets of the heart valve prosthesis are preferably provided exclusively along the same, preferably one-half, one-third, one-quarter of the periphery of the tubular stent or its end, or along any other portion.

[0039] In some embodiments, the internal valve leaflets are preferably arranged within a tubular stent so as to form, for example, anterior, posterior, and septal leaflets, one first leaflet and preferably a second and third leaflet, or any multiple leaflets. In this configuration, the internal valve leaflets allow fluid to flow in one direction (referred to as the downstream direction) when they are opened or pushed apart from each other. However, fluid flow in the opposite direction (referred to as the upstream direction) causes the internal valve leaflets to close or push against each other, so that the heart valve prosthesis mimics the function of a natural valve (check valve).

[0040] In some embodiments, the external leaflets are arranged to form at least one leaflet, preferably multiple leaflets, more preferably a first leaflet, a second leaflet, and a third leaflet. Multiple external leaflets can be positioned on the outside of the tubular stent and therefore may not have stent-related counterparts. The external leaflets have a base connected to the orifice of the stent, a flexible free leaflet edge (which moves freely and is not attached to the stent), and a corresponding number of commissures, depending on the number of external leaflets, to which the external leaflets are connected (e.g., sewn) to a stent commissure structure / strut parallel to the longitudinal axis of the stent. In this configuration, when a heart valve prosthesis is implanted and the internal leaflets close to each other, the flexible free leaflet margins open and close to regulate blood flow, thereby closing off the external leaflets to the original (disease-affected) leaflets or tissue, preventing the flow of fluid or blood between them, for example, in the upstream direction. However, when the external leaflets are opened or pushed toward the stent, for example, they allow fluid flow in the opposite direction (called the downstream direction). Thus, the external leaflets function as leaflets that allow the flow of fluid or blood in one direction but do not completely block blood flow or seal around the heart valve prosthesis like a sealing cuff.

[0041] In some embodiments, the heart valve prosthesis is an atrioventricular valve, a mitral valve, or a tricuspid valve. The heart valve prosthesis can be implanted in or is intended to be implanted in the congenital mitral valve.

[0042] In some embodiments, the heart valve prosthesis according to the present invention may be covered or partially covered by a sheath, preferably in a folded state. The sheath is intended to forcibly hold and maintain the heart valve prosthesis, particularly some or all of the stent, internal and external leaflets, and / or anchors, in their folded position until, for example, the intended implantation site of the heart valve prosthesis is reached.

[0043] In some embodiments, preferably when the tubular stent is in an expanded state, the area of ​​the cross-section of the tubular stent, for example, the area of ​​the cross-section perpendicular to the longitudinal axis A of the tubular stent, is 0.3 cm². 2 ~5cm 2 It comprises a range of dimensions. The cross-section of the expanded tubular stent can be fitted or selected according to the expected facets of the original heart valve being replaced, which may depend on the size, species, and / or weight of the respective mammal.

[0044] In some embodiments, with a heart valve prosthesis implanted, the angle α between the longitudinal axis A of the tubular stent and the axis B extending perpendicularly to the surface of the congenital heart valve or the surface of the mitral valve ring of the congenital heart valve is set in the range of 0° to 90°, preferably 20° to 60°, and most preferably 30° to 50°.

[0045] Therefore, the surface of the innate heart valve can be defined by an axis 300y, referred to as the anterior-posterior direction, and an axis 300x, referred to as the lateral direction, both axes preferably perpendicular to each other and also perpendicular to axis B. The heart valve prosthesis can be implanted and / or securely fixed at an oblique or inclined position relative to the surface of the innate heart valve, particularly with respect to the anterior-posterior axis 300y and / or the lateral axis 300x. That is, the plane perpendicular to the longitudinal axis A of the tubular stent may be inclined with respect to the anterior-posterior axis 300y in the plane defined by axis B and the anterior-posterior axis 300y, or may form a first angle, and / or the plane perpendicular to the longitudinal axis A of the tubular stent may be inclined with respect to the lateral axis 300x in the plane defined by axis B and the lateral axis 300x of the innate heart valve 300 or mitral valve ring 307, or may form a second angle.

[0046] In some embodiments, the heart valve prosthesis, particularly the internal leaflets or lobes, the external leaflets or lobes, the eyelets, the anchors, and / or the fixation sutures, are made from biological or non-biological materials, or artificial materials.

[0047] Non-biological materials can be, for example, plastics, metals, and / or other durable materials. The advantage of using non-biological materials is that structural degradation of the manufactured heart valve prosthesis is avoided, resulting in the heart valve prosthesis having long-term durability.

[0048] The biological material may be, for example, animal-derived biological tissue such as, preferably pre-treated, pig, cattle, and / or horse tissue, or mammalian-derived biological tissue intended to receive a heart valve prosthesis. The advantage of using a biological material is that a heart valve prosthesis thus produced does not require lifelong systemic anticoagulation therapy, in contrast to artificial heart valve prostheses, which are prone to blood clotting and increase the risk of embolism.

[0049] In some embodiments, the heart valve prosthesis is a check valve, or at least has the function of a check valve, or mimics the function of a check valve.

[0050] In some embodiments, the cardiac valve prosthesis is preferably configured to seal the tubular stent to the natural tissue, for example, to the natural aortic valve, and / or does not have, or is not disclosed, an external cuff.

[0051] In some embodiments, the method of inserting, implanting, and / or fixing a cardiac valve prosthesis according to the present invention may include or encompass intravascular insertion of the cardiac valve prosthesis into, for example, a jugular vein, such as a mammalian jugular vein.

[0052] In some embodiments of the method for manufacturing a heart valve prosthesis according to the present invention, providing a fixation suture includes, after implanting a heart valve prosthesis in the mitral valve of the left atrium, providing a fixation suture of sufficient length to reach an external location in the left atrium, for example, the atrial septum, preferably the superior vena cava, or more preferably a more proximal jugular vein, and to fix or bind it, or to maintain that state, or after implanting a heart valve prosthesis in the tricuspid valve of the right atrium, providing a fixation suture of sufficient length to reach an external location in the right atrium, preferably the superior vena cava, or more preferably a more proximal jugular vein, and to fix or bind it, or to maintain that state.

[0053] In some embodiments of a method for manufacturing a heart valve prosthesis, the fixing sutures are connected to or attached to the eyelets, for example, by tying or sewing.

[0054] In some embodiments, the method for manufacturing a heart valve prosthesis further includes the step of positioning, securely fixing, and / or connecting external valve leaflets to the outer surface of a tubular stent.

[0055] In some embodiments of a method for manufacturing a heart valve prosthesis, the external valve leaflets 151-156 are formed by attaching, for example, a sheet formed of a biocompatible material, which is for example frustoconical, preferably round in shape, and having a central through-opening and a free leaflet margin, to, for example, a corresponding number of joints parallel to the longitudinal axis of the stent, to, for example, the mesh or joint structure / strut(s) of a tubular stent, for example. The material may be biological, non-biological, or artificial.

[0056] In some embodiments of a method for manufacturing a heart valve prosthesis, some, most, or all of the fixation sutures and / or eyelets are provided along the end of the tubular stent, preferably along the periphery of the distal end or end portion of the tubular stent, or along only half, one-third, or one-quarter of the periphery of the distal end of the tubular stent.

[0057] In some embodiments of a method for manufacturing a heart valve prosthesis, the internal leaflets are arranged and securely fixed and / or connected, preferably within a tubular stent, to form one leaflet, two leaflets, preferably three leaflets, for example, anterior leaflet, posterior leaflet, septal leaflet, or any multiple leaflets.

[0058] In some embodiments, the internal valve leaflets are instead structured to block blood flow within the stent in both directions during systole and diastole.

[0059] In some embodiments of a method for manufacturing a heart valve prosthesis, the external leaflets are arranged to form at least one leaflet, preferably a plurality of leaflets, more preferably a first leaflet, a second leaflet, and a third leaflet. The plurality of external leaflets can be arranged around the outer shape of a tubular stent.

[0060] In some embodiments, a method for manufacturing a heart valve prosthesis further includes the step of covering the heart valve prosthesis at least partially with a stent and some or all of the external leaflets, internal leaflets, and / or anchors so that they are forcibly held or can be forcibly held in a folded state. Such a cover can be implemented, for example, by a sheath capable of maintaining the folded heart valve prosthesis in its folded position until it reaches the intended implantation site.

[0061] In some embodiments, the method for inserting a heart valve prosthesis according to the present invention further includes a step of retracting a cover or sheath so that the heart valve prosthesis can exhibit or return to its expanded state.

[0062] In some embodiments, the method for inserting a heart valve prosthesis further includes the step of positioning and / or orienting the heart valve prosthesis by, for example, changing the length of one or more of the fixation sutures. This can be done by manipulating the lengths of the individual fixation sutures to tilt the heart valve prosthesis in all possible directions, making it possible to move the proximal end of the tubular stent out of the original heart valve being replaced, for example, from the left ventricle into the atrium.

[0063] In some embodiments, the heart valve prosthesis is tilted and directed by fixation sutures to move the distal end of the stent away from the left ventricular outflow tract and to avoid outflow tract obstruction caused by the heart valve prosthesis.

[0064] In some embodiments, the step of positioning and / or orienting the heart valve prosthesis may include orienting and securely fixing the heart valve prosthesis such that the angle α between the longitudinal axis A of the tubular stent and the axis B extending perpendicular to the surface of the mitral valve ring of the replacement heart valve, for example, the original heart valve, is in the range of 0° to 90°, preferably 20° to 60°, and most preferably 30° to 50°.

[0065] In some embodiments, the surface of a natural heart valve can be defined by an axis 300y referred to as the anterior-posterior direction and an axis 300x referred to as the lateral direction, both axes preferably perpendicular to each other and also perpendicular to axis B, and the heart valve prosthesis can be embedded and / or securely fixed to the surface of the natural heart valve at an angle or inclination, particularly in the anterior-posterior axis 300y and / or the lateral axis 300x. That is, the plane perpendicular to the longitudinal axis A of the tubular stent may be inclined with respect to the anterior-posterior axis 300y in the plane defined by axis B and the anterior-posterior axis 300y, or may form a first angle, and / or the plane perpendicular to the longitudinal axis A of the tubular stent may be inclined with respect to the lateral axis 300x in the plane defined by axis B and the lateral axis 300x of the natural heart valve 300 or mitral valve ring 307, or may form a second angle.

[0066] In some embodiments, the method for inserting a heart valve prosthesis further includes the step of connecting the fixation sutures, for example, by tying them to a natural mammalian structure, such as an anchor or natural tissue.

[0067] In some embodiments, particularly when a heart valve prosthesis is implanted, the angle α between the longitudinal axis A of the tubular stent and the axis B extending perpendicularly to the surface of the mitral valve ring of the original heart valve is set in the range of 0° to 90°, preferably 20° to 60°, and most preferably 30° to 50°.

[0068] In some embodiments, the delivery of the cardiac valve prosthesis to the implantation site can be performed minimally invasively, for example, percutaneously, transluminally, intercostally, and / or intravascularly, through an opening in the jugular vein, subclavian vein, femoral vein, or other blood vessel, or through an opening at the apex of the left ventricle. The advantages of using such endovascular techniques are that they offer strong benefits in terms of health, safety, and cost. In particular, because the required invasiveness to the mammalian body is minimized, a significant reduction in the use of general anesthesia and / or the associated hospital stay or clinic stay can be achieved.

[0069] Some or all embodiments of the present invention may have one, some, or all of the advantages described above and / or described below.

[0070] All the advantages that can be achieved by the method according to the present invention can also be achieved without impairment in certain specific embodiments of the present invention relating to heart valve prostheses, and vice versa.

[0071] The present invention is described below purely illustratively with reference to the accompanying drawings. In the drawings, the same reference numerals indicate the same or similar components. [Brief explanation of the drawing]

[0072] [Figure 1] This figure shows an exemplary embodiment of a purely exemplary mitral valve atrioventricular valve prosthesis according to the present invention. [Figure 1a] This figure shows the internal valve leaflets of a heart valve prosthesis. [Figure 2] This figure shows a further exemplary embodiment of a purely exemplary mitral valve heart valve prosthesis according to the present invention. [Figure 3] This figure shows a further exemplary embodiment of a purely exemplary mitral valve heart valve prosthesis according to the present invention in use. [Figure 3a] This figure shows the angle between the anchor and the stent in the embodiment shown in Figure 3. [Figure 4] This figure shows a schematic representation of the heart valve prosthesis in its implanted state. [Figure 5] This figure shows a further embodiment of an implanted heart valve prosthesis, illustrating its position and fixation within the heart. [Figure 6] This is a top view of a mitral valve, which is an exemplary bicuspid valve in a state of incompetence or dysfunction, into which a purely exemplary tricuspid valve or mitral valve prosthesis according to the present invention is implanted. The x-axis represents the lateral direction (plane), and the y-axis represents the anterior-posterior direction (plane). [Figure 6a] Figure 6 shows a mitral valve from above, with a purely exemplary tricuspid or mitral valve prosthesis implanted according to the present invention. [Figure 7] This figure shows an exemplary process of a method for manufacturing a heart valve prosthesis, preferably according to the present invention. [Figure 8] This figure shows an exemplary process for inserting, implanting, and / or fixing a purely exemplary tricuspid or mitral valve prosthesis, preferably according to the present invention, into the jugular vein of a dog. [Modes for carrying out the invention]

[0073] Figure 1 shows an exemplary embodiment of the atrioventricular valve prosthesis 1000 according to the present invention. The cardiac valve prosthesis 1000 is implantable and preferably intended to be implanted, fixed, and / or securely fixed in the heart of a mammal to replace or substitute the valve function, particularly the check valve function, of a dysfunctional or defective congenital heart valve. The cardiac valve prosthesis 1000 may be a bicuspid or tricuspid valve. In Figure 1, the cardiac valve prosthesis 1000 comprises a tubular stent 100 and three internal valve leaflets 110 positioned within or inside the lumen L of the tubular stent 100 at its proximal end. The tubular stent 100 may be foldable and expandable. The cardiac valve prosthesis 1000 may be configured and / or positioned to prevent unidirectional regurgitation, particularly regurgitation from ventricular blood to atrium.

[0074] In this figure and the following figures, the upper part of the stent is referred to as the "proximal" part herein, and the lower part is referred to as the "distal" part herein (see the explanation for Figure 5).

[0075] In the example in Figure 1a, a purely optional foldable and expandable tubular stent 100 having a lumen L can be expanded, for example, during use and / or after implantation at an implantation site, e.g., into a dysfunctional or defective congenital heart valve. The tubular stent 100 is shown in its fully expanded state. The lumen L preferably has an opening cross-sectional area or opening area smaller than the opening area of ​​a congenital mammalian heart valve, e.g., a congenital atrioventricular valve, whose function is replaced, repaired or substituted by a heart valve prosthesis 1000.

[0076] In this example, three optional internal valve leaflets 110 are positioned, attached, secured, and / or fixed or connected to the lumen L of the tubular stent 100, particularly inside the lumen L. The internal valve leaflets 110 can preferably be positioned and / or attached to one end of the tubular stent 100, preferably to one end of the tubular stent 100 intended to prevent blood flow from the ventricle to the atrium after implantation, for example, at the proximal opening or hole of the tubular stent 100.

[0077] Figure 1a shows the internal valve leaflets 110 of the heart valve prosthesis 1000 in Figure 1, without the tubular stent 100, for clarity.

[0078] In the example in Figure 1a, there are three internal valve leaflets 110, although this is illustrative. The number of valve leaflets 110 is purely illustrative and should not be understood as limiting. The internal valve leaflets 110 are positioned and / or configured to close the heart valve prosthesis 1000 by contacting each other when a fluid, such as blood, flows from the proximal end (the upper end of the tubular stent 100 in Figure 1) to the distal end (the lower end of the tubular stent 100 in Figure 1). The block arrows indicate the possible fluid flow from the proximal end to the distal end of the tubular stent 100. After the heart valve prosthesis 1000 is implanted with its proximal opening entering, for example, the atria 404, 405 (see Figure 5) and its distal opening entering the ventricles 406, 407 (see Figure 5), blood flow from the ventricles 406, 407 (see Figure 5) to the atria 404, 405 (see Figure 5) is prevented. On the other hand, blood flow from atria 404 and 405 (see Figure 4) to ventricles 406 and 407 (see Figure 5) is possible.

[0079] Figure 2 shows a further exemplary embodiment of the heart valve prosthesis 1000 according to the present invention.

[0080] The heart valve prosthesis 1000, although merely illustrative, is designed and configured as a tricuspid valve in which three internal leaflets 110 are located within a tubular stent 100 and positioned at one end of the tubular stent 100. In the example in Figure 2, an external flange or cone portion 180, preferably made of a biocompatible material, is attached to the tubular stent 100, particularly to the outer shape of the tubular stent 100, to form the external leaflets 151-156 (not shown in Figure 2; see Figures 3, 4, and 6a). The flange or cone portion 180 can preferably be rounded, preferably frustoconical, and preferably have a central circular opening 181 and a flexible free leaflet margin 158. The attachment of the flange portion 180 to the stent 100 is indicated by block arrows.

[0081] The outer flange-like or conical portion 180 may optionally have a central through-opening 181, the periphery 183 of which can be attached to or fixed to one end of a tubular stent 100 that supports or includes the internal valve leaflets 110. The outer circumference of such a conical portion is referred to as the outer circumference 182 of the flange-like or conical portion 180. The periphery of the through-opening 181 is referred to as the periphery 183 of the through-opening 181.

[0082] A portion of the flange or cone portion 180 can be bent along the longitudinal direction, length, or multiple portions of the tubular stent 100, or along or on the outer surface of the tubular stent 100, for example, as will be shown in detail with respect to the following figures, and can be attached or connected to the tubular stent 100, for example, by sewing, for example, to the mesh of the tubular stent 100, for example, at the joint 211 and / or other portions of the flange or cone portion 180, for example, at the periphery 183 of the through opening 181. The step of attaching or connecting the above portion of the flange or cone portion 180 to the tubular stent 100 is schematically represented in Figure 2 by four curved downward arrows. In Figure 2, as an example, the flange or cone portion 180 has four joints 211 and four valve leaflets 151, 152, 153, 154 (not visible). The joint 211 of the flange-shaped or conical portion is sutured to the stent mesh (strut) along the longitudinal diameter of the stent.

[0083] Figure 3 shows a further exemplary embodiment of the purely exemplary tricuspid valve heart valve prosthesis 1000 according to the present invention in use and / or fully deployed.

[0084] Please refer to the reference numerals and descriptions in the preceding drawings. Only differences or additions to these are mentioned below.

[0085] The heart valve prosthesis 1000, in particular the tubular stent 100, includes eyelets 160 that do not preferably contribute to the foldable and expandable properties of the tubular stent 100. In the example shown in Figure 3, the eyelets 160 are positioned radially on the upper edge of the tubular stent 100, surrounding the tubular stent 100 at substantially equal and / or predetermined, preferably equal, distances. This position can also be defined radially between the internal valve leaflets 110 and the external valve leaflets 151-156.

[0086] In the example shown in Figure 3, the heart valve prosthesis 1000 has six exemplary eyelets 160 positioned at approximately equal distances around the periphery of the end or upper edge of the tubular stent 100. However, the number and position of the eyelets 160 are purely illustrative and should not be understood as limiting.

[0087] The eyelet 160 may be a connection point or part of a connection structure for fixing or connecting at least one or more threads 130 (not shown in Figure 3; see Figures 4 and 5) to the tubular stent 100.

[0088] Instead of the eyelet 160, other parts of the tubular stent 100 may be directly or indirectly attached to or connected to the fixing thread 130.

[0089] In some embodiments, the eyelets 160 can each be connected to a tubular stent 100 and / or one or more proximal anchors, which are not shown in Figure 3.

[0090] In the example shown in Figure 3, multiple distal anchors 170, which are connected to or part of the tubular stent 100, are shown at the distal end of the tubular stent 100.

[0091] The anchor 170 has a first end and a second end, the first end being directly or indirectly connected to the tubular stent 100 in a separable or non-separable manner, and the second end being the free end opposite the first end, which preferably swings radially outward.

[0092] At least some of the distal anchors 170 are positioned such that, for example, when not subjected to radial compression, force, or pressure from the sheath, the angle between the distal anchor and the tubular stent 100 is less than a right angle, and the angle is preferably 5° to 90°, more preferably 10° to 30°.

[0093] Preferably, the anchor 170 is designed such that, during use of the heart valve prosthesis 1000, particularly in the expanded state of the tubular stent 100, the anchor 170 can engage with the tissue of the innate valve and / or mitral valve notochord and / or mitral valve annulus by its free end (see Figure 4, not shown), thereby ensuring that the heart valve prosthesis 1000 can be securely fixed or fixed within the innate valve.

[0094] Figure 4 shows an embodiment of the heart valve prosthesis 1000 of Figure 3, implanted within the mitral valve ring 307 of the congenital mitral valve 300.

[0095] There are three exemplary anchoring threads 130, which are directly or indirectly connected to the tubular stent 100, for example, by the first end of each thread 130 connected to each eyelet 160. Optionally, two or more anchoring threads 130 can be connected to a single or the same eyelet 160. The number of anchoring threads 130, the location where the anchoring threads 130 are connected to the tubular stent 100, and the connection of the anchoring threads 130 to the eyelets 160 are merely examples and should not be understood as limiting.

[0096] Although optional, in this example, only eyelets 160 located along half of the periphery of the tubular stent 100, for example, the right half of the periphery (as viewed from the observer's line of sight), or located along a portion of the periphery of the tubular stent 100, are used for connection to the fixation suture 130. This may contribute to maintaining the necessary and / or intended tilt or oblique orientation of the heart valve prosthesis 1000 within the innate mitral valve 300 or mitral valve ring 307, which may be intended and / or required for the heart valve prosthesis 1000 to function properly. Furthermore, to avoid left ventricular outflow tract stenosis, it may be intended to move the distal portion of the valve prosthesis away from the left ventricular outflow tract. The tilt or oblique orientation can be defined as an angle α. The angle α can be defined as the angle formed between the longitudinal axis A of the tubular stent 100 and the axis B which is perpendicular to the surface enclosed by the surface of the natural heart valve or the natural mitral valve ring 307.

[0097] For example, the connections between the three fixing threads 130 and the tubular stent 100 are preferably inseparable, or can be configured to at least maintain the connections during use of the valve prosthesis after implantation.

[0098] The fixing suture 130 is guided through the atrial septum 201 and through the intraatrial perforation 203 so that it is fixed to the outside of the atrium (not shown, see Figure 5).

[0099] As shown in Figure 4, the anchor 170 can engage with the tissue of the innate valve, for example, the mitral valve 300, during the use of the heart valve prosthesis 1000, and here it is illustrated that it can engage with the innate posterior mitral valve leaflet 302a of the posterior mitral valve 302, and / or the innate anterior mitral valve leaflet 301a of the anterior mitral valve 301.

[0100] Figure 5 shows a further embodiment of the heart valve prosthesis 1000 according to the present invention, implanted in, for example, a heart 400, illustrating an exemplary position within the innate heart 400 and an exemplary corresponding fixation state.

[0101] Please refer to the explanation in the preceding drawings.

[0102] In the example shown in Figure 5, the heart valve prosthesis 1000 is implanted with its proximal end oriented cranially and its distal end oriented caudally.

[0103] The fixation suture 130 is fixed or woven into the outside of the left atrium 404 in the jugular vein 401 of the heart 400. Preferably, the fixation suture 130 is long enough to be present and / or remain there after the cardiac valve prosthesis 1000 has been implanted between the left ventricle 406 and the left atrium 404.

[0104] Alternatively, some or all of the fixation sutures 130 may be fixed to or woven into any location outside the atrial septum or left atrium 404, for example, not too distal, such as the superior vena cava 403.

[0105] Figure 6 shows from above a non-performing or dysfunctional congenital mitral valve 300 into which the heart valve prosthesis 1000 according to the present invention is implanted.

[0106] Figure 6 shows that within the congenital mitral valve ring 307, the congenital anterior mitral valve leaflet 301a and the congenital posterior mitral valve leaflet 302a do not close properly. Therefore, the opening 305 remains open during the closing action of the congenital anterior mitral valve leaflet 301a and the congenital posterior mitral valve leaflet 302a, leading to cardiac valve insufficiency.

[0107] Figure 6a shows the mitral valve 300 of Figure 6 with the heart valve prosthesis 1000 according to the present invention implanted, from above.

[0108] Please refer to the explanation in the preceding drawings.

[0109] In the embodiment shown in Figure 6a, the heart valve prosthesis 1000 comprises, exemplary, three internal leaflets 110 and six external leaflets 151, 152, 153, 154, 155, and 156. The heart valve prosthesis 1000 is fixed between the congenital anterior mitral leaflet 301a and the congenital posterior mitral leaflet 302a, as described herein. For clarity, the eyelets 160 and fixation sutures 130 are omitted.

[0110] Figure 7 shows an exemplary process for manufacturing a cardiac valve prosthesis 1000 that can be implanted in a congenital heart 400, preferably according to the present invention.

[0111] Please refer to the explanation in the preceding drawings.

[0112] In step M1 of the method, a foldable and expandable tubular stent 100 having a lumen L is prepared. The lumen L preferably has an opening cross-sectional area or opening area that is smaller than the opening area of ​​the natural atrioventricular valve whose function is replaced by the heart valve prosthesis 1000, either during use of the stent 100 or when fully expanded. The tubular stent 100 further has an anchor, preferably a distal anchor 170, which can or can be configured to engage with the natural tissue of the natural heart valve, preferably in the expanded state of the tubular stent 100.

[0113] In step M2 of the method, at least one of the following is performed: positioning, connecting, and / or attaching the internal valve leaflets 110 within the lumen L of the tubular stent 100, and positioning, connecting, and / or attaching the external valve leaflets 151-156.

[0114] In some embodiments of this method, step M2 may include arranging the internal valve leaflet 110 to form, for example, one valve leaflet and preferably a second valve leaflet and a third valve leaflet, or any number of internal valve leaflets.

[0115] In a further step M3, at least one fixing thread 130 is connected directly or indirectly to the tubular stent 100, for example, by the first end or free end of each thread, or provided as an integral part of the tubular stent 100. This connection is preferably inseparable so that at least one fixing thread 130 remains connected during use of the valve prosthesis 1000 after implantation.

[0116] In some embodiments of this method, at least one of the fixation sutures 130 may be of sufficient length to be fixed or bound to, or maintain in such a state, at an external location in the left atrium, for example, the atrial septum, preferably the superior vena cava 403, or more preferably a more proximal jugular vein 401, after the cardiac valve prosthesis 1000 has been implanted in the mitral valve of the left atrium, or at such a state to be fixed or bound to, or maintain in such a state, at an external location in the right atrium, preferably the superior vena cava 403, or more preferably a more proximal jugular vein 401, after the cardiac valve prosthesis 1000 has been implanted in the tricuspid valve of the right atrium. This can be included in step M3 of the method.

[0117] In step M4 of the method, at least one or more fixing threads 130 are connected to the eyelets 160 provided on the stent 100 for this purpose.

[0118] In some embodiments, this step may include providing some, all, or most of the fixing threads 130 and / or eyelets 160 along the entire periphery 183 of the through-opening of the flange-shaped or conical portion 180, or only a portion of the periphery, for example, along half of the periphery, or for example, along half of the periphery of the tubular stent 100.

[0119] In step M6, the external valve leaflets 151-156 are positioned on the outer surface of the tubular stent 100. In some embodiments of this method, step M6 may include positioning and / or connecting the joints 211 of the flange or frustoconical portion 180 to the outer shape of the tubular stent 100, for example, to form a desired number of joints 211 and external valve leaflets 151-156.

[0120] In some embodiments, these external valve leaflets 151-156 can be formed by attaching a disc-shaped or frustoconical portion 180, preferably made of a round material and having a central through-opening 181, to the tubular stent 100, for example, its mesh, for example, by sewing it on. The attachment of the disc-shaped portion 180 can be considered a separate method step M5.

[0121] In some embodiments of this method, the external valve leaflets 151-156 are arranged to form at least one valve leaflet, preferably a plurality of valve leaflets, more preferably a first valve leaflet, a second valve leaflet, and a third valve leaflet. This corresponds to step M7 of the method.

[0122] In step M8 of the method, the heart valve prosthesis 1000 is covered with a sheath (not shown) so that some or all of the heart valve prosthesis, particularly the tubular stent 100, the leaflets 110, 151-156, and / or the anchor 170, are forcibly held and / or maintained in their folded or compressed state.

[0123] While optional, the above steps may be performed in the order described above, with some or all of them overlapping in time or simultaneously.

[0124] Figure 8 shows an exemplary process for inserting a cardiac valve prosthesis 1000 into the heart, preferably the jugular vein 401, according to the present invention.

[0125] Please refer to the explanation in the preceding drawings.

[0126] In step S1 of the method, a heart valve prosthesis 1000, preferably according to the present invention, is prepared.

[0127] In step S2, the heart valve prosthesis 1000 is brought into the right atrium 405 to position it within the opening 305 of a natural heart valve, such as a bicuspid or tricuspid valve. This allows the heart valve prosthesis 1000 to pass through the perforation 203 in the atrial septum 201, particularly in a folded or retracted state. The folded or retracted heart valve prosthesis 1000 may be enclosed by a sheath or covered by some material to facilitate passage of the heart valve prosthesis 1000 to its intended implantation site.

[0128] In step S3 of the method, the material or sheath surrounding the heart valve prosthesis 1000, which is in a folded state, is retracted so that some or all of the heart valve prosthesis 1000, particularly the tubular stent 100, the internal leaflets 110 and the external leaflets 151-156, and / or the anchor 170, can expand and / or be in an expanded state.

[0129] In step 4 of the method, the heart valve prosthesis 1000 is positioned and / or directed by changing the length of one or more of the fixation sutures 130. This can be done, for example, by manipulating the lengths of the individual fixation sutures 130 to tilt the heart valve prosthesis 1000. For example, by moving the proximal end of the tubular stent 100 from below the original heart valve to be replaced, for example from the left ventricle 406 to the left atrium 404, and moving the distal end of the stent, for example, from the left ventricular outflow tract, an angle α between the longitudinal axis A of the implanted heart valve prosthesis 1000 and the plane of the original mitral valve ring 307 of the original heart is obtained or maintained. This angle α can be in the range of 0° to 90°, preferably 20° to 60°, and most preferably 30° to 50°.

[0130] In step S5 of the method, the fixing thread 130 is connected, for example, to an innate structure or innate tissue of a mammal, for example, by tying it. [Explanation of Symbols]

[0131] 1000 Heart valve prostheses 100 (tubular) stent 110 Internal leaflet 130 Fixing thread 151 First external valve leaflet 152 Second external valve leaflet 153 Third external valve leaflet 154 Fourth external valve leaflet 155 Fifth external valve leaflet 156 Sixth external valve leaflet 158 Free external valve tip 160 eyelets 170 Anchors 171 Angle between the anchor and the (tubular) stent 180 Outer flange-shaped portion, disc-shaped portion, or frustoconical portion 181 Through-opening 182 Outer circumference of the flange-like part 183 Periphery of the through-opening of the flange-like portion 201 Atrial septum 203 Intraatrial perforation 211 Joint 300 Mitral valve 300x horizontal 300y front and back direction 301 Anterior mitral valve 301a Congenital premitral valve leaflets 302 Posterior mitral valve 302a Congenital posterior mitral valve leaflets 305 Mitral valve insufficiency 307 Mitral valve ring 400 Natural Heart 401 Jugular vein 403 Superior vena cava 404 Left atrium 405 Right atrium 406 Left ventricle 407 Right ventricle Method steps for manufacturing M1-M8 heart valve prostheses Steps for inserting heart valve prostheses (S1-S5) Lumen of L-shaped tubular stent 100 A Longitudinal axis of the tubular stent 100 B. An axis perpendicular to the plane of the congenital heart valve 300 or mitral valve ring 307.

Claims

1. An atrioventricular valve prosthesis (1000) that can be implanted in the heart of a mammal, A foldable and expandable tubular stent (100) having a lumen, wherein the lumen has an opening cross-sectional area or opening area smaller than the opening area of ​​the natural atrioventricular valve replaced by the cardiac valve prosthesis (1000) during use of the stent (100) or when fully expanded, The tubular stent (100) has internal valve leaflets (110) which are placed inside the lumen and which close the heart valve by contacting each other, At least one fixing thread (130) directly or indirectly connected to the tubular stent (100), A heart valve prosthesis equipped with [specific features / features].

2. A heart valve prosthesis (1000) according to claim 1, A heart valve prosthesis (1000) wherein, after implantation of the heart valve prosthesis (1000), at least one fixing suture (130) is long enough to be fixed or bound to the outside of the atrium, or to maintain that state.

3. A heart valve prosthesis (1000) according to claim 2, The heart valve prosthesis is to be implanted in the mitral valve of the left atrium of the heart of the mammal, and after implantation of the heart valve prosthesis (1000), the at least one fixing suture (130) is fixed or bound to a position outside the left atrium, or is of sufficient length to maintain that position.

4. A heart valve prosthesis (1000) according to claim 3, A heart valve prosthesis (1000) wherein, after implantation of the heart valve prosthesis (1000), at least one fixation suture (130) is of sufficient length to be fixed to or bound to one of the mammalian atrial septum (201), superior vena cava (403), or jugular vein (401), or to maintain that state.

5. A heart valve prosthesis (1000) according to claim 2, The heart valve prosthesis is to be implanted in the tricuspid valve of the right atrium of the heart of the mammal, and after implantation of the heart valve prosthesis (1000), at least one fixation suture (130) is fixed or bound to a position outside the right atrium, or is of sufficient length to maintain that position.

6. A heart valve prosthesis (1000) according to claim 5, A heart valve prosthesis (1000) wherein, after implantation, at least one fixing suture (130) is long enough to be fixed to or bound to one of the superior vena cava (403) or jugular vein (401) of the mammal, or to maintain that state.

7. A heart valve prosthesis (1000) according to claim 1, A heart valve prosthesis comprising an eyelet (160) or other part which is part of the tubular stent (100) or is directly or indirectly attached to the tubular stent (100) so as to connect at least one fixing thread (130) to the tubular stent (100), or to at least one fixing thread (130).

8. A heart valve prosthesis (1000) according to claim 1, A heart valve prosthesis in which the internal valve leaflets (110) positioned within the lumen of the tubular stent (100) form a structure that does not open in order to allow blood flow upstream or downstream through the lumen of the tubular stent (100).

9. A heart valve prosthesis (1000) according to claim 3, The eyelet (160) is connected to the proximal portion of the tubular stent (100), and is a cardiac valve prosthesis.

10. A heart valve prosthesis (1000) according to claim 3 or 4, The fixing thread (130) is connected to the eyelet (160) of the heart valve prosthesis.

11. A heart valve prosthesis (1000) according to claim 1, External valve leaflets (151-156) arranged on the outer surface of the tubular stent (100), which, in particular when implanted, are configured to close the valve to the natural tissue, preferably to the natural atrioventricular valve leaflets, during systole, and to open during diastole to allow blood flow from the atrium to the ventricle, A heart valve prosthesis that further enhances these features.

12. A heart valve prosthesis (1000) according to claim 6, The external valve leaflets (151-156) are preferably formed by a disc-shaped portion or a frustoconical portion (180) having a central through-opening (181) made of a rounded material, and a portion of the disc-shaped portion (180) is attached to the tubular stent (100), for example, by sewing it to its mesh, in a heart valve prosthesis.

13. A heart valve prosthesis (1000) according to claim 1, The tubular stent (100) is provided with a plurality of anchors (170), preferably distal anchors (170), which are preferably connected to the tubular stent at its distal end or which are part of the tubular stent (100). A heart valve prosthesis that further enhances these features.

14. A heart valve prosthesis (1000) according to claim 8, A heart valve prosthesis comprising an anchor (170) having a first end and a second end, the first end being connected to the tubular stent (100), and the second end being a free end located opposite the first end.

15. A heart valve prosthesis (1000) according to claim 1, A heart valve prosthesis in which at least some of the distal anchors (170) are positioned such that, when not subjected to radial compression, force, or pressure, the angle between the distal anchors and the tubular stent (100) is less than a right angle with respect to the longitudinal axis A of the tubular stent (100), preferably between 5° and 90°, more preferably between 10° and 30°.

16. A heart valve prosthesis (1000) according to claim 1, A cardiac valve prosthesis in which the fixing sutures (130) and / or the eyelets (160) are provided along the entire periphery of the tubular stent (100), or alternatively, along only a portion of the periphery of the tubular stent (100).

17. A heart valve prosthesis (1000) according to claim 1, A cardiac valve prosthesis in which the internal valve leaflets are arranged to form one valve leaflet and preferably a second valve leaflet and a third valve leaflet.

18. A heart valve prosthesis (1000) according to claim 1, A cardiac valve prosthesis in which the external valve leaflets are arranged to form at least one, preferably multiple, and more preferably a first, second, and third valve leaflet.

19. A heart valve prosthesis (1000) according to claim 1, The cardiac valve prosthesis (1000) is a cardiac valve prosthesis that is an atrioventricular valve, a mitral valve, or a tricuspid valve.

20. A heart valve prosthesis (1000) according to claim 1, A heart valve prosthesis, at least partially covered by a sheath, the sheath forcibly holding or maintaining the heart valve prosthesis (1000) in a folded state, particularly while the heart valve prosthesis (1000) is displaced to its intended embedded state.

21. A method for manufacturing a heart valve prosthesis (1000) that can be implanted in the heart of a mammal, preferably according to claim 1, The steps include: preparing a foldable and expandable tubular stent (100) having a lumen, wherein the lumen preferably has an opening cross-sectional area or opening area smaller than the opening area of ​​the mammalian atrioventricular valve that is replaced by the cardiac valve prosthesis (1000) during use or when the stent (100) is fully expanded; The steps include: positioning the internal valve leaflet (110) within the lumen (L) of the tubular stent (100); The steps include providing a fixing thread (130) that is directly or indirectly connected to the tubular stent (100) or is an integral part of the tubular stent (100), Methods that include...

22. The method according to claim 21, A method wherein, after the implantation of the cardiac valve prosthesis (1000), the fixation suture (130) is of sufficient length to be fixed or bound to the outside of the atrium, or to maintain that state.

23. The method according to claim 21, A method wherein, after implanting the heart valve prosthesis (1000) in the mitral valve of the left atrium of the heart of the mammal, the fixation suture (130) is of sufficient length to fix or tie to the outside of the left atrium or to maintain that state.

24. The method according to claim 23, A method wherein the fixing suture (130) is of sufficient length to be fixed to or bound to one of the atrial septum (201), superior vena cava (403), or jugular vein (401) of the mammal, or to maintain that state.

25. The method according to claim 21, A method comprising implanting the heart valve prosthesis (1000) into the tricuspid valve of the right atrium of the heart of the mammal, wherein the fixation suture (130) is of sufficient length to fix or tie to the outside of the right atrium or to maintain that state.

26. The method according to claim 25, The fixation thread (130) is of sufficient length to be fixed to or bound to one of the superior vena cava (403) or jugular vein (401) of the mammal, or to maintain that state.

27. The method according to claim 21, The fixing thread (130) is connected to the eyelet (160).

28. The method according to claim 21, The step of arranging external valve leaflets (151-156) on the outer surface of the tubular stent (100), A method that further encompasses it.

29. The method according to claim 21, The method involves attaching a disc-shaped portion or frustoconical portion (180) having a central through-opening (181) and a free leaf edge (158) to the external valve leaflets (151-156), preferably made of a rounded material, for example, by sewing a corresponding number of valve joints (211) to, for example, the mesh or valve leaflet joint structure / strut of the tubular stent (100) parallel to the longitudinal axis of the stent.

30. The method according to claim 21, A method wherein the fixing thread (130) and / or the eyelet (160) are provided along the entire periphery of the tubular stent (100), or along only a portion of the periphery of the tubular stent (100).

31. The method according to claim 21, The method wherein the internal valve leaflets (110) are arranged to form one valve leaflet and preferably a second valve leaflet and a third valve leaflet.

32. The method according to claim 21, A method wherein the external valve leaflets (151-156) are arranged to form at least one valve leaflet, preferably a plurality of valve leaflets, more preferably a first valve leaflet, a second valve leaflet, and a third valve leaflet.

33. The method according to claim 21, A method further comprising the step of covering the heart valve prosthesis (1000) such that the sheath forces some or all of the anchors (170) to be held in their folded state.

34. A method for inserting a heart valve prosthesis (1000) into the jugular vein of a mammal, The steps of preparing the heart valve prosthesis (1000) described in claim 1 and / or manufacturing the heart valve prosthesis (1000) described in claim 21, The steps include: positioning the heart valve prosthesis (1000) within the opening of a natural valve, such as a tricuspid valve, by bringing the heart valve prosthesis (1000) into the right atrium; This involves the step of passing the heart valve prosthesis (1000) through the perforation in the atrial septum, Methods that include...

35. The method according to claim 34, A step of contracting the sheath so that some or all of the anchors (170) can exhibit their expanded state, A method that further encompasses it.

36. The method according to claim 25, A step of positioning and / or oriented and / or tilting the heart valve prosthesis (1000) by changing the length of one or more of the fixing threads (130), A method that further encompasses it.

37. The method according to claim 25, The step of connecting the fixing thread (130) to the innate structure or tissue of the mammal, for example by tying it, A method that further encompasses it.

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