Valve prosthesis and methods of making and using valve prosthesis

Abstract

The present invention relates to an atrio-ventricular heart valve prosthesis which is implantable into a heart, e.g., of a mammal. The heart valve prosthesis comprises a collapsible- expandable tubular stent with an inner lumen, the inner lumen, during use or in a fully expanded state of the stent, preferably having an opening cross section or area, that is smaller than the opening area of the native atrio-ventricular heart valve that is to be replaced by the heart valve prosthesis. It further comprises interior valvular cusps arranged within the inner lumen of the tubular stent that are closing the heart valve by resting against each other, outer leaflets that close against the native valve leaflets and at least one anchoring thread that is, directly or indirectly, connected to the tubular stent. The invention further relates to a method for producing a heart valve prosthesis and a method for inserting a heart valve prosthesis.

Description

[0001] VALVE PROSTHESIS AND

[0002] METHODS OF MAKING AND USING VALVE PROSTHESIS

[0003] The present invention relates to a prosthetic valve , in particular for implantation in a heart , especially in a minimally invasive or percutaneous manner, and more particularly to a heart valve prosthesis configured and suitable for replacement of a mammalian heart valve , most particularly an atrio-ventricular heart valve , mitral valve , bicuspid and / or tricuspid valve . The present invention further relates to a method for producing a heart valve prosthesis according to claim 21 and to a method of inserting, implanting and / or anchoring a heart valve prosthesis according to claim 25 .

[0004] An obj ect of the present invention is to speci fy a further heart valve prosthesis , a method for producing a heart valve prosthesis and a method for inserting, implanting and / or anchoring a heart valve prosthesis .

[0005] The heart valve prosthesis , preferably an atrio-ventricular heart valve prosthesis , according to the present invention i s designed, configured and / or suitable to be implantable into a mammalian heart .

[0006] The heart valve prosthesis according to the present invention comprises at least one , preferably collapsible-expandable , tubular stent having an inner lumen . The inner lumen, preferably during use or in a fully expanded state of the stent , preferably has an opening cross section or area, that is smaller than the opening area of the native heart valve , e . g . , than the opening area of an atrio-ventricular heart valve , e . g . , of a mammal , that is to be replaced by the heart valve prosthesis . The heart valve prosthesis according to the present invention further comprises at least one , two , preferably three or four , interior valvular cusps or leaflets arranged within the inner lumen of the tubular stent that are closing the valve by resting against each other . The interior valvular cusps or leaflets may be provided and / or configured, especially in an implanted state , for closing the heart valve during systole and for opening, e . g . , by being pushed apart , the heart valve during diastole , in order to allow a blood flow, e . g . , from the atrium into the ventricle . The interior valvular cusps or leaflets are preferably arranged at or close to the proximal aperture of the tubular stent . The proximal aperture may be one of the two ends apertures of the tubular stent . The inner valvular cusps may alternatively be configured as a collapsible structure that does not open in order to allow blood flow through the proximal aperture of the tubular stent and instead blocks the blood flow through the proximal aperture in the stent in both directions , during systole and diastole .

[0007] The heart valve prosthesis according to the present invention further comprises at least one , two , preferably three or four , anchoring threads that are , or may be , directly or indirectly, connected to the tubular stent , e . g . , by a first or free end of the respective thread, or that are an integral part of the tubular stent . The anchoring threads may be connected to the tubular stent , e . g . , to an exterior surface of the tubular stent , preferably before implantation, preferably in a non-detachable manner and / or in order to stay connected with the tubular stent during use of the valve prosthesis after implantation .

[0008] The method according to the present invention for producing a heart valve prosthesis , in particular for producing a heart valve prosthesis according to the present invention, at least comprises or encompasses the step of providing a, preferably collapsible-expandable, tubular stent with an inner lumen. The inner lumen of the tubular stent, preferably during use or in a fully expanded state of the tubular stent, preferably has an opening cross section or area, that is smaller than the opening area of the native heart valve, e.g., of a native atrioventricular heart valve, e.g., of a mammal, that is to be replaced by the heart valve prosthesis.

[0009] The method according to the present invention for producing a heart valve prosthesis further comprises or encompasses the step of arranging, securing and / or attaching, e.g., sewing and / or knotting, at least one, two, preferably three or four, interior valvular cusps or leaflets within the inner lumen of the tubular stent. The interior valvular cusps or leaflets may be provided and / or configured, especially in an implanted state, for closing the heart valve during systole and for opening, e.g., by being pushed apart, the heart valve during diastole, in order to allow a blood flow, e.g., from the atrium into the ventricle. The inner valvular cusps may alternatively be configured as a collapsible structure that does not open in order to allow blood flow through the proximal aperture of the tubular stent and instead blocks the blood flow through the proximal aperture in the stent in both directions, during systole and diastole.

[0010] The method according to the present invention for producing a heart valve prosthesis further comprises or encompasses the step of providing for at least one, two, preferably three or four, anchoring threads. The anchoring threads may be, directly or indirectly, connected to the tubular stent, e.g., by a first or free end of the respective thread, or may be an integral part of the tubular stent. The anchoring threads may be connected to the tubular stent in a non-detachable manner and / or in order to stay connected during use of the valve prosthesis after implantation . The method according to the present invention for inserting, implanting and / or anchoring a heart valve prosthesis , in particular for inserting, implanting and / or anchoring a heart valve prosthesis according to the present invention and / or for inserting, implanting and / or anchoring a heart valve prosthesis produced according to the producing method according to the present invention, at least comprises or encompasses the step of providing and / or producing at least one heart valve prosthesis , in particular a heart valve prosthesis according to the present invention .

[0011] The method for inserting, implanting and / or anchoring the heart valve prosthesis according to the present invention further comprises or encompasses the step of forwarding the heart valve prosthesis to the right atrium of the heart in order to position the heart valve prosthesis within an opening of the native heart valve to be replaced, e . g . , within an opening of a native tricuspid or mitral valve .

[0012] The method for inserting, implanting and / or anchoring the heart valve prosthesis according to the present invention further comprises or encompasses the step of passing the heart valve prosthesis through a perforation in an intra-atrial septum, e . g . , in a septum lying between the left atrium and the right atrium in order to , e . g . , position the heart valve prosthesi s within an opening of the native heart valve to be replaced, e . g . , within an opening of a native mitral valve .

[0013] Embodiments according to the present invention may comprise some , several or all of the following features in any combination, unless the person skilled in the art recogni zes their combination as technically impossible . In all the following statements , the use of the expression "may be" or "may have" and so on, is to be understood synonymously with "preferably is" or "preferably has , " and so on respectively, and is intended to illustrate embodiments according to the present invention .

[0014] Whenever numerical words are mentioned herein, the person skilled in the art shall recogni ze or understand them as indications of a numerical lower limit . Unless it leads the person skilled in the art to an evident contradiction, the person skilled in the art shall comprehend the speci fication for example of "one" ( also "a / an") as encompassing "at least one" . This understanding is also equally encompassed by the present invention as the interpretation that a numeric word, for example , "one" ( also "a / an") may alternatively mean "exactly one" , wherever this is evidently technically possible for the person skilled in the art . Both understandings are encompassed by the present invention and apply herein to all used numerical words .

[0015] Whenever spatial information, such as e . g . , "top" , "bottom" , " left" or "right" is mentioned herein, the person skilled in the art understands this to mean the arrangement in the herein- attached figures and / or in the state of use . "Bottom" is closer to the center of the earth o t? the bottom of the figure than "top" .

[0016] The terms "proximal" ( from Latin proximus ' nearest ' ) and "distal" ( from Latin distare ' to stand away from ' ) are herein used to describe parts or locations that are close to or distant from the main mass of the body, respectively . The "proximal end" of the heart valve prosthesis is defined herein as the end o f the tubular stent where the interior valvular cusps are connected or attached to . The opposite end of the stent i s referred to herein as "distal end" of the heart valve prosthesis .

[0017] Please confer to the descriptions of Fig . 1 and Fig . 5 for more detailed explanation .

[0018] Advantageous developments of the present invention are each subj ect-matter of the dependent claims and embodiments .

[0019] Whenever an embodiment is mentioned herein, it is then an exemplary embodiment according to the present invention which is not to be understood as limiting .

[0020] When it is disclosed herein that the sub ect-matter according to the present invention comprises one or several features in a certain embodiment , it is also respectively disclosed herein that the subj ect-matter according to the present invention does , in other embodiments , likewise according to the present invention, explicitly not comprise this or these features , for example , in the sense of a disclaimer . Therefore , for every embodiment mentioned herein it applies that the converse embodiment , e . g . , formulated as negation, is also disclosed .

[0021] When programmed or configured is mentioned herein, then these terms may in some embodiments be interchangeable .

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

[0023] In several embodiments of the heart valve prosthesis according to the present invention, at least one , preferably a plurality of anchoring threads is / are long enough to be or to remain anchored or laced at a position outside of the left atrium, e . g . , at the intra-atrial septum, preferably at the Vena Cava Superior, or more preferably further proximal at the Vena Jugularis , after implantation of the heart valve prosthesis in the mitral valve of the left atrium, or outside of the right atrium, preferably at the Vena Cava Superior, or more preferably further proximal at the Vena Jugularis , after implantation o f the heart valve prosthesis in the tricuspid valve of the right atrium .

[0024] In some embodiments , the heart valve prosthesis comprises at least one , or more eyelets , or other sections , that are preferably part of the tubular stent , or attached to it , directly or indirectly, for connecting and / or attaching at least one anchoring thread to the tubular stent , or for being connected and / or attached to at least one anchoring thread . The least one , or more eyelets , or other sections , do preferably not contribute to the collapsible-expandable nature of the tubular stent .

[0025] In several embodiments , the eyelets are connected to a , preferably proximal , external or internal , section of the tubular stent , preferably a circumference of the tubular stent .

[0026] In some embodiments of the heart valve prosthesis , the anchoring threads are connected and / or attached, directly or indirectly, optionally in a detachable manner or non-detachable manner, to the eyelets .

[0027] In several embodiments , the heart valve prosthesis according to the present invention further comprises exterior valvular cusps or leaflets arranged, attached and / or secured at an outer surface of the tubular stent .

[0028] The heart valve prosthesis may comprise at least one , two preferably three up to six exterior valvular cusps , preferably close to the proximal aperture of the tubular stent , provided and configured for closing the valve against native tissue , preferably against the native atrio-ventricular valve cusps, e.g., against a posterior and / or an anterior mitral valve leaflet, in particular in an implanted state and / or during systole. The exterior valvular cusps may further be provided and configured for opening, in particular in an implanted state and / or during diastole, in order to allow a blood flow, e.g., from the left atrium into the left ventricle.

[0029] In some embodiments, the exterior valvular cusps are formed by a disc or brim of material, round in shape, preferably a truncated cone having a central through opening. Thus, the shape may also be referred to as a cone herein.

[0030] In several embodiments, sections of the disc, brim or cone, in particular sections of the external circumference of the disc, brim or cone and / or of the circumference of the through opening, are attached, e.g., sewed, to the tubular stent, particularly to an exterior or exterior surface of the tubular stent, e.g., to a mesh thereof. Sections of the circumference of the through opening may preferably be attached to a proximal end of the tubular stent. Sections of the external circumference of the disc may preferably be attached to, or along, a section of the tubular stent below the proximal end of the tubular stent, preferably at a predetermined distance thereof, e.g., at a distal end thereof and / or at any other section therebetween.

[0031] In some embodiments, the heart valve prosthesis further comprises at least one, or a plurality of, preferably distal, anchors which are connected to, or part of, the tubular stent, preferably at a distal end thereof.

[0032] In several embodiments, the tubular stent has exclusively one, at least one, or more, preferably distal, anchor (s) . In some embodiments the distal anchors are, evenly or unevenly, distributed, preferably along a circumference of the distal end, or end section, of the tubular stent, or only along a section, e.g., a half, a third, a fourth, of the circumference of the distal end of the tubular stent.

[0033] In several embodiments, the tubular stent has no distal and / or no proximal anchor, in particular no anchors for, directly or indirectly, anchoring the heart valve prosthesis with tissue of the native heart valve to be replaced.

[0034] In several embodiments, the anchors have a first end and a second end, wherein the first end is connected to the tubular stent, and wherein the second end is a free end, opposite to the first end .

[0035] In some embodiments at least one anchor is constructed and / or configured to swing radially outward at its free end.

[0036] In some embodiments, at least one, some or all of said, preferably distal, anchors are provided to assume a position forming at an angle between the distal anchors and the tubular stent that is smaller than rectangular position, with regard to a longitudinal axis A of the tubular stent, preferably between 5° and 90°, more preferably between 10° and 30° towards the distal end of the stent when being without radial constraints, forces or pressure, e.g., by a sheath.

[0037] In several embodiments, a majority or all of the anchoring threads, of the anchors and / or of the eyelets of the heart valve prosthesis are exclusively provided along, preferably the same, one half, one third, one fourth, or any other section of the circumference of the tubular stent or end thereof. In some embodiments, the interior valvular cusps are arranged so as to form one first cusp and preferably a second cusp and a third cusp, or any plurality of cusps, e.g., as cuspis anterior, cuspis posterior, cuspis septalis, preferably arranged within the tubular stent. With this arrangement, the interior valvular cusps allow a liquid flow in one direction (referred to as a downstream direction) , e.g., when they open or are pushed away from each other. A liquid flow in the opposite direction (referred to as a upstream direction) however, closes or pushes the interior valvular cusps against each other so that the heart valve prosthesis imitates the (check-valve) function of a natural valve.

[0038] In several embodiments, the exterior valvular cusps are arranged so as to form at least one cusp, preferably a plurality of cusps, more preferably a first cusp, a second cusp, a third cusp. The plurality of exterior valvular cusps may be disposed at an exterior of the tubular stent and have thus no stent related counter parts. The exterior valvular cusps have a base, connected to the stent orifice, a flexible free leaflet edge (moves freely and is not attached to the stent) and, depending on the number of exterior valvular cusps, a corresponding number of commissures where the exterior valvular cusp is connected (e.g., sewn) to the stent commissural structure / strut , parallel to the stent longitudinal axis. With this arrangement, when the heart valve prosthesis is implanted and the interior valvular cusps close against each other, the flexible free leaflet edge opens and closes to regulate blood flow such that the exterior valvular cusps close against the native (diseased) valve leaflets or tissues to prevent a liquid or blood flow therebetween, e.g., in a upstream direction, but they allow a liquid flow in the opposite direction (referred to as a downstream direction) , e.g., when they open or are pushed towards the stent. Thus the exterior valvular cusps act as valve leaflets allowing liquid or blood flow in one direction, but not closing off blood flow entirely or sealing around the heart valve prosthesis as would a sealing cuff.

[0039] In some embodiments, the heart valve prosthesis is an atrioventricular valve, a mitral heart valve or a tricuspid valve. The heart valve prosthesis may be or is intended to be implanted into a native mitral heart valve.

[0040] In several embodiments, the heart valve prosthesis according to the present invention is, or may be, at least in part, covered by a sheath, preferably in in collapsed state. The sheath is intended to force and maintain the heart valve prosthesis, in particular the stent, the interior and exterior valvular cusps and / or some or all of the anchors in a collapsed position thereof, e.g., until reaching the intended implantation site of the valve heart prosthesis.

[0041] In some embodiments, the surface of a cross-section of the tubular stent, e.g., a cross section area perpendicular to the longitudinal axis A of the tubular stent, preferably in an extended state of the tubular stent, is comprised in a range of 0.3cm2to 5cm2. The surface of the cross-section of the extended tubular stent may be adapted or chosen according to the expected surface of the native heart valve to be replaced which may depend on the size, race and / or weight of the respective mammalian.

[0042] In several embodiments, in an implanted state of the heart valve prosthesis, an angle a between the longitudinal axis A of the tubular stent and an axis B extending perpendicular to the surface of the native heart valve or of the mitral annulus of the native heart valve is comprised in a range from zero to 90°, preferably 20 to 60°, most preferably in a range from 30 to 50°. The surface of the native heart valve may thereby be defined by an axis 300y referred to as an anterior posterior direction and an axis 300x referred to as a lateral direction, both axis being preferably perpendicular to each other and to the axis B . The heart valve prosthesis may be implanted and / or secured oblique or tilted, with regard to the surface of the native heart valve , in particular in an anterior posterior axis direction 300y and / or in a lateral axis direction 300x, i . e . , a plane perpendicular to the longitudinal axis A of the tubular stent may be inclined, or form a first angle , with the anterior posterior axis 300y in a plane defined by the axis B and the anterior posterior axis 300y, and / or a plane perpendicular to the longitudinal axis A of the tubular stent may be inclined, or form a second angle with the lateral axis 300x in a plane defined by the axis B and the lateral axis 300x of the native heart valve 300 or of the mitral annulus 307 .

[0043] In some embodiments , the heart valve prosthesis , in particular the interior valvular cusps or leaflets , the exterior valvular cusps or leaflets , eyelets , anchors and / or anchoring threads are made of biological or non-biological or arti ficial materials .

[0044] Non-biological materials may be for example plastics , metals and / or other durable materials . An advantage of using non- biological materials is that structural deterioration of the produced heart valve prosthesis is avoided, and thus , the heart valve prosthesis has a long-term durability .

[0045] Biological material may be for example biological or tissues from animals , such as e . g . , porcine , bovine and / or equine tissues , preferably previously treated, or from the mammalian intended to receive the heart valve prosthesis . An advantage of using biological materials is that the produced heart valve prosthesis does not require li fe-long full systemic anticoagulation, contrary to artificial heart valve prosthesis which are prone to blood clotting and increase a risk of embolism.

[0046] In several embodiments, the heart valve prosthesis is a checkvalve, or has, or imitates, at least the function of a checkvalve .

[0047] In several embodiments, the heart valve prosthesis does not comprise or disclose an, preferably exterior cuff, in particular no exterior cuff configured and / or arranged for sealing the tubular stent against native tissues, e.g., against a native aortic valve.

[0048] In some embodiments, the method for inserting, implanting and / or anchoring the heart valve prosthesis according to the present invention in particular may comprise or encompass endovascular insertion of the heart valve prosthesis, e.g., into a jugular vein, e.g., of a mammal.

[0049] In several embodiments of the method for producing a heart valve prosthesis according to the present invention, providing the anchoring threads includes providing anchoring threads that are long enough to reach, to be or to remain anchored or laced at a position outside of the left atrium, e.g., at the intra-atrial septum, preferably at the Vena Cava Superior, or more preferably further proximal at the Vena Jugularis, after implantation of the heart valve prosthesis in the mitral valve of the left atrium, or outside of the right atrium, preferably at the Vena Cava Superior, or more preferably further proximal at the Vena Jugularis, after implantation of the heart valve prosthesis in the tricuspid valve of the right atrium. In some embodiments of the method for producing a heart valve prosthesis, the anchoring threads are, or are being connected, e.g., knotted or sewed, to the eyelets.

[0050] In several embodiments, the method for producing a heart valve prosthesis further encompasses the step of arranging, securing and / or connecting exterior valvular cusps at an outer surface of the tubular stent.

[0051] In some embodiments of the method for producing a heart valve prosthesis, the exterior valvular cusps (151 to 156) are formed by attaching a sheet, e.g., a truncated cone, of, preferably biocompatible, material, preferably round in shape, having a central through opening and free leaflet edge, e.g., by sewing, to a corresponding number of commissures to the tubular stent parallel to the longitudinal axis of the stent, e.g., to a mesh thereof or commissural structure / strut ( s ) . The material may be biological or non-biological , or artificial material.

[0052] In several embodiments of the method for producing a heart valve prosthesis, some, a majority, or all of the anchoring threads and / or of the eyelets are, or are being provided along the end of the tubular stent, preferably along a circumference of the distal end, or end section, of the tubular stent, or only along a section thereof, e.g., a half, a third, a fourth, of the circumference of the distal end of the tubular stent.

[0053] In some embodiments of the method for producing a heart valve prosthesis, the interior valvular cusps are, or are being arranged, secured and / or connected, preferably within the tubular stent, so as to form one cusp two cusps preferably three cusp, e.g., as cuspis anterior, cuspis posterior, cuspis septalis, or any plurality of cusps. In some embodiments the inner valvular cusps are alternatively made of a structure that is blocking the flow in the stent in both directions , in systole and diastole .

[0054] In several embodiments of the method for producing a heart valve prosthesis , the exterior valvular cusps are being arranged so as to form at least one cusp preferably a plurality of cusps , more preferably a first cusp, a second cusp, a third cusp . The plurality of exterior valvular cusps may be disposed at an exterior of the tubular stent .

[0055] In some embodiments , the method for producing a heart valve prosthesis further comprises the step of covering, at least in part , the heart valve prosthesis such that the stent , the exterior and interior cusps and / or some or all of the anchors are or may be forced in a collapsed state thereof . Such a cover may be exemplarily implemented by a sheath preferably maintaining the collapsed valve heart prosthesis in a collapsed position thereof , e . g . , until reaching the intended implantation site of the valve heart prosthesis .

[0056] In some embodiments , the method for inserting a heart valve prosthesis according to the present invention further encompasses the step of retracting the cover or the sheath such that the heart valve prosthesis may assume or recover an expanded state thereof .

[0057] In several embodiments , the method for inserting a heart valve prosthesis further encompasses the step of positioning and / or orienting the heart valve prosthesis , e . g . , by changing the length of one or more of the anchoring threads . This may be done by manipulating the length of individual anchoring threads in order to tilt the heart valve prosthesis in all possible directions , allowing the movement of the proximal end of the tubular stent out of the native heart valve to be replaced, e . g . , out of the left ventricle into the atrium .

[0058] In several embodiments the heart valve prosthesis is tilted and oriented by means of the anchoring threads with the intent to move the distal end of the stent away from the left ventricular outflow tract , avoiding outflow tract obstruction caused by the heart valve prosthesis .

[0059] In some embodiments , the step of positioning and / or orienting the heart valve prosthesis may comprise orienting and securing the heart valve prosthesis so that an angle a between the longitudinal axis A of the tubular stent and an axis B extending perpendicular to the surface of heart valve to be replaced, e . g . , of the mitral annulus of the native heart valve , i s comprised in a range from zero to 90 ° , preferably 20 ° to 60 ° , most preferably in a range from 30 ° to 50 ° .

[0060] In several embodiments , the surface of the native heart valve may be defined by an axis 300y referred to as an anterior posterior direction and an axis 300x referred to as a lateral direction, both axis being preferably perpendicular to each other and to the axis B and the heart valve prosthesis may be implanted and / or secured oblique or tilted, with regard to the surface of the native heart valve , in particular in an anterior posterior axis direction 300y and / or in a lateral axis direction 300x, i . e . , a plane perpendicular to the longitudinal axis A o f the tubular stent may be inclined, or form a first angle , with the anterior posterior axis 300y in a plane defined by the axis B and the anterior posterior axis 300y, and / or a plane perpendicular to the longitudinal axis A of the tubular stent may be inclined, or form a second angle with the lateral axis 300x in a plane defined by the axis B and the lateral axis 300x of the native heart valve 300 or of the mitral annulus 307 . In some embodiments, the method for inserting a heart valve prosthesis further encompasses the step of connecting, e. g., knotting, the anchoring threads to a native structure, e.g., anchor, or native tissue, e.g., of the mammal.

[0061] In several embodiments, in particular in an implanted state of the heart valve prosthesis, an angle a between the longitudinal axis A of the tubular stent and an axis B extending perpendicular to the surface of the mitral annulus of the native heart valve is comprised in a range from zero to 90°, preferably 20° to 60°, most preferably in a range from 30° to 50°.

[0062] In some embodiments, the delivery of the heart valve prosthesis at the implantation site may occur minimal invasive, e.g., percutaneous, transluminal, intercostal, and / or endovascular, e.g., through an opening at a jugular, subclavian or femoral vein, or other blood vessel, or at the apex of the left ventricle. An advantage of using such endovascular techniques has strong benefit from the standpoint of health, safety and costs. In particular only minimal invasion of the mammalian body is required so that at least a considerable reduction of the use of a general anesthesia and / or of the duration of related hospital or clinic stay is achievable.

[0063] Some or all embodiments according to the present invention may have one, several or all of the advantages mentioned above and / or below .

[0064] All the advantages that may be achieved with the methods according to the invention may also be achieved undiminished in certain embodiments according to the present invention with the heart valve prosthesis, and vice versa. The present invention is described below purely exemplarily with reference to the accompanying figures . In them, the same reference numerals designate identical or similar components . The following applies :

[0065] Fig . 1 shows an exemplary embodiment of a, purely exemplary mitral , atrio-ventricular heart valve prosthesis according to the present invention;

[0066] Fig . la shows the interior valvular cusps of the heart valve prosthesis of Fig . 1 ;

[0067] Fig . 2 shows a further exemplary embodiment of a, purely exemplary mitral , heart valve prosthesis according to the present invention;

[0068] Fig . 3 shows a further exemplary embodiment of a, purely exemplary mitral , heart valve prosthesis according to the present invention during use ;

[0069] Fig . 3a shows the angle between the anchors and stent of the embodiment in Fig . 3 ;

[0070] Fig . 4 shows the embodiment of the heart valve prosthesis of Fig . 3 in a schematically represented implanted state ;

[0071] Fig . 5 shows a further embodiment of a heart valve prosthesis in an implanted state , showing its position in the heart and its anchoring;

[0072] Fig . 6 shows an incompetent or dys functional , exemplarily bicuspid, mitral valve from above into which a, purely exemplary tricuspid or mitral , heart valve prosthesis according to the present invention is to be implanted, x axis showing lateral direction (plane ) and y axis showing anterior-posterior direction (plan) ;

[0073] Fig . 6a shows the mitral valve of Fig . 6 with an implanted, purely exemplary tricuspid or mitral , heart valve prosthesis according to the present invention from above ;

[0074] Fig . 7 shows an exemplary course of a method for producing a heart valve prosthesis , preferably according to the present invention; and

[0075] Fig . 8 shows an exemplary course of a method for inserting, implanting and / or anchoring a, purely exemplary tricuspid or mitral , heart valve prosthesis , purely exemplary into a j ugular vein of a canine , preferably according to the present invention .

[0076] Fig . 1 shows an exemplary embodiment of an atrio-ventricular heart valve prosthesis 1000 according to the present invention, which is implantable and intended to be implanted, anchored and / or secured into the heart of a mammal , preferably for replacing or substituting the valve function, in particular check valve function, of a dys functional or defective native heart valve . The heart valve prosthesis 1000 may be bicuspid or tricuspid . In Fig . 1 the heart valve prosthesis 1000 comprises a tubular stent 100 and three interior valvular cusps 110 arranged in or within the lumen L of the tubular stent 100 , at the proximal end of the tubular stent 100 . The tubular stent 100 may be collapsible-expandable . The heart valve prosthesis 1000 may especially be configured and / or arranged to prevent a backflow in one direction, in particular from ventricular blood to the atrium . In this and the following figures, the upper part of the stent is herein referred to as "proximal", the lower part is herein referred to as "distal" (see the description with regard to Fig . 5 ) .

[0077] In the example of Fig. 1 a, purely optionally collapsible- expandable, tubular stent 100 with an inner lumen L is shown in a fully expanded state to which it may expand, e.g., during use and / or after implantation at the implantation site, e.g., at the dysfunctional or defective native heart valve. The Inner lumen L preferably has an opening cross section or area, that is smaller than the opening area of the native heart valve, e.g., of the native atrio-ventricular heart valve of e.g., a mammal, that is, or which function is to be replaced, repaired or substituted by the heart valve prosthesis 1000.

[0078] In this example, optionally three interior valvular cusps 110 are arranged, attached, fastened and / or fixed within, or connected to, in particular an interior of, the inner lumen L of the tubular stent 100. The interior valvular cusps 110 may preferably be arranged and / or attached at one end of the tubular stent 100, preferably at one end of the tubular stent 100 which is intended to prevent a blood flow from the ventricle into the atrium after implantation, e.g., at a proximal opening or aperture of the tubular stent 100.

[0079] Fig. la shows the interior valvular cusps 110 of the heart valve prosthesis 1000 of Fig. 1 for a better overview without the tubular stent 100.

[0080] In the example of Fig. la there are exemplarily three interior valvular cusps 110. The number of cusps 110 is purely exemplary and is not to be understood as limiting. The interior valvular cusps 110 are arranged and / or configured such that they are closing the heart valve prosthesis 1000 by resting against each other, e.g., when a liquid, e.g., blood, flows from the proximal end (in Fig. 1, the top of the tubular stent 100) to the distal end (in Fig. 1, the low end of the tubular stent 100) . The block arrow indicates a possible liquid flow from the proximal to the distal end of the tubular stent 100. After implantation of the heart valve prosthesis 1000 with the proximal end opening, e.g., into an atrium 404, 405 (see Fig. 4) , and the distal end opening into a ventricle 406, 407 (see Fig. 4) , a blood flow from a ventricle 406, 407 (see Fig. 4) into an atrium is 404, 405 (see Fig. 4) will be prevented. On the other hand, a blood flow from the atrium 404, 405 (see Fig. 4) into a ventricle 406, 407 (see Fig. 4) will be possible.

[0081] Fig. 2 shows a further exemplary embodiment of a heart valve prosthesis 1000 according to the present invention.

[0082] The heart valve prosthesis 1000 is purely exemplary designed and configured as a tricuspid valve with three interior valvular cusps 110 arranged at one end of a tubular stent 100 within the tubular stent 100. In the example of Fig. 2, an exterior brim or cone 180 of, preferably biocompatible, material is attached to the tubular stent 100, in particular to an exterior of the tubular stent 100, in order to form exterior valvular cusps 151 to 156 (not shown in Fig. 2, see Fig. 3, Fig. 4 and Fig. 6a) . The brim or cone 180 may preferably be round preferably a truncated cone and may preferably have a central circular opening 181 and a flexible free leaflet edge 158. Attaching the brim 180 to the stent 100 is represented by a block arrow.

[0083] The exterior brim or cone 180 may optionally have a central through opening 181, which circumference 183 may be attached or fixed to the one end of the tubular stent 100 supporting or comprising the interior valvular cusps 110. The external circumference of such a cone is referred to as the external circumference 182 of the brim or cone 180. The circumference of the through opening 181 is referred to as the circumference 183 of the through opening 181

[0084] Sections of the brim or cone 180 may be folded down along the longitude, length or sections of the tubular stent 100, e.g., along or on the external surface of the tubular stent 100, and may be attached or connected, e.g., sewed, preferably at the commissures 211 of the brim or cone 180, and / or at other sections, e.g., at the circumference 183 of the through opening 181, to the tubular stent 100, e.g., to a mesh thereof, as shown, e.g., in detail with regard to the following figures. The step of attaching or connecting said sections of the brim or cone 180 to the tubular stent 100 is schematically represented in Fig. 2 by the four arrows curving down. As example in Fig. 2 the brim or cone 180 has four commissures 211 and four cusps 151, 152, 153 154 (not visible) . The brim or cone commissures 211 are sutured to the stent mesh (strut) along the stent longitudinal diameter .

[0085] Fig. 3 shows a further exemplary embodiment of a purely exemplary tricuspid heart valve prosthesis 1000 according to the present invention during use and / or in a fully deployed state.

[0086] Reference is made to the reference numerals and descriptions regarding the preceding figures. Only differences therefrom or complements thereto are mentioned in the following.

[0087] The heart valve prosthesis 1000, in particular the tubular stent 100, comprises eyelets 160 which do preferably not contribute to the collapsible-expandable nature of the tubular stent 100. In the example of Fig. 3 the eyelets 160 are positioned radially at the upper edge of the tubular stent 100, surrounding it at nearly equal and / or predetermined, preferably equal, distances. This position may also be defined being radially between the interior valvular cusps 110 and the exterior valvular cusps 151 to 156.

[0088] In the example of Fig. 3 the heart valve prosthesis 1000 has exemplarily six eyelets 160 disposed around the circumference of the end or upper edge of the tubular stent 100 at approximately equal distances. The number and position of the eyelets 160 is, however, purely exemplary and is not to be understood as limiting.

[0089] The eyelets 160 may be intended to be connection points, or to be part of a connection, for anchoring at least one or more threads 130 (not shown in Fig. 3, see Fig. 4 and Fig. 5) in order to fix them at the tubular stent 100, or to connect them thereto .

[0090] Instead of eyelets 160, other sections of the tubular stent 100 may be attached or connected, directly or indirectly, to the anchoring threads 130, respectively.

[0091] In some embodiments the eyelets 160 may be connected to the tubular stent 100 and / or to one or more proximal anchor (s) respectively. This is not shown in Fig. 3.

[0092] A plurality of, in the example of Fig. 3 distal, anchors 170 which are connected to, or parts of, the tubular stent 100, are shown at a distal end thereof.

[0093] The anchors 170 have a first end and a second end, wherein the first end is connected, directly or indirectly, in a detachable or undetachable manner, to the tubular stent 100, and wherein the second end is a free end, opposite to the first end, preferably swinging radially out.

[0094] At least some of said distal anchors 170 are provided to assume a position forming an angle 171 between the distal anchors and the tubular stent 100 that is smaller than rectangular position with regard to a longitudinal axis A of the tubular stent 100, preferably between 5° and 90°, more preferably between 10° and 30° when being without radial constraints, forces or pressure, applied, e.g., by a sheath.

[0095] The anchors 170 are preferably designed such that they may engage with their free end with tissue of a native valve and or mitral valve chordae and or mitral valve annulus during use (not shown, see Fig. 4) , in particular in an extended state of the tubular stent 100, so that the heart valve prosthesis 1000 may be secured or fixed within said native valve.

[0096] Fig. 4 shows the embodiment of the heart valve prosthesis 1000 of Fig. 3 in an implanted state within a mitral annulus 307 of a native mitral valve 300.

[0097] There are purely exemplarily three anchoring threads 130 that are, directly or indirectly, connected to the tubular stent 100, e.g., by a first end of the respective thread 130 that is connected to a respective eyelet 160. Optionally, two or more anchoring threads 130 may be connected to a single or the same eyelet 160. The number of the anchoring threads 130, the position where they are connected to the tubular stent 100 and that they are connected to eyelets 160 is purely exemplary and is not to be understood as limiting.

[0098] Optionally, only eyelets 160 arranged or provided along a half, e.g., the right half, of the circumference (line of sight of the viewer ) of the tubular stent 100 , or a section thereof , are used for being connected to the anchoring threads 130 in thi s example . This may contribute to a necessary and / or intended tilt or oblique orientation of the heart valve prosthesis 1000 within the native mitral valve 300 , or mitral annulus 307 , which may be intended and / or needed so that the heart valve prosthesis 1000 functions properly . Further, it may be intended to move the distal part of the valve prosthesis away from the left ventricular outflow tract to avoid left ventricular outflow tract stenosis . The tilt or oblique orientation may be defined as an angle a . The angle a may be defined as the angle formed between a longitudinal axis A of the tubular stent 100 and an axis B being perpendicular to the surface of the native heart valve or to the surface surrounded by the native mitral annulus 307 .

[0099] The connection between the exemplarily three anchoring threads 130 and the tubular stent 100 is preferably non- detachable , or may at least be configured such that the connection remains during use of the valve prosthesis after implantation .

[0100] The anchoring threads 130 are guided through the intra-atrial septum 201 through an intra-atrial perforation 203 in order to be fixed outside of the atria (not shown, see Fig . 5 ) .

[0101] It is shown in Fig . 4 that the anchors 170 may engage with tissue of a native , e . g . , mitral , valve 300 during use , here exemplarily with a native posterior mitral valvular cusp 302a of a posterior mitral valve 302 and / or a native anterior mitral valvular cusp 301a of an anterior mitral valve 301 .

[0102] Fig . 5 shows a further embodiment of a heart valve prosthesis 1000 according to the present invention implanted, e.g., into a heart 400, in an implanted state, showing an exemplary position in a native heart 400 and an exemplary, corresponding anchoring.

[0103] Reference is made to the description with regard to the preceding figures .

[0104] In the example of Fig. 5 the heart valve prosthesis 1000 is implanted with its proximal end oriented cranial and with its distal end oriented caudal.

[0105] The anchoring threads 130 are anchored or laced outside of the left atria 404 at the Vena Jugularis 401 of the heart 400. They are preferably long enough to be and / or to remain there after implantation of the heart valve prosthesis 1000 between the left ventricle 406 and the left atrium 404.

[0106] Alternatively to the embodiment shown, some or all of the anchoring threads 130 may be anchored or laced at the intra- atrial septum or any location outside the left atrium 404, e.g., less distal, e.g., at the Vena Cava Superior 403.

[0107] Fig. 6 shows an incompetent or dysfunctional native mitral valve 300 from above into which a heart valve prosthesis 1000 according to the present invention is to be implanted.

[0108] It can be seen in Fig. 6 that, within the native mitral valve annulus 307, the native anterior mitral valvular cusp 301a and the native posterior mitral valvular cusp 302a do not close properly. Therefore, an opening 305 remains during the closing action of the native anterior mitral valvular cusp 301a and the native posterior mitral valvular cusp 302a, resulting in an heart valve insufficiency. Fig . 6a shows the mitral valve 300 of Fig . 6 with an implanted heart valve prosthesis 1000 according to the present invention from above .

[0109] Reference is made to the description with regard to the preceding figures .

[0110] In the embodiment of Fig . 6a the heart valve prosthesis 1000 exemplary displays three interior valvular cusps 110 and six exterior valvular cusps 151 , 152 , 153 , 154 , 155 , 156 . The heart valve prosthesis 1000 is anchored between the native anterior mitral valvular cusp 301a and the native posterior mitral valvular cusp 302a analogously to the description herein . Eyelets 160 and anchoring threads 130 have been omitted for the sake of clarity .

[0111] Fig . 7 shows an exemplary course of a method for producing a heart valve prosthesis 1000 , preferably according to the present invention, which is implantable into a native heart 400 .

[0112] Reference is made to the description with regard to the preceding figures .

[0113] Method step Ml represents providing a collapsible-expandable tubular stent 100 with an inner lumen L . The inner lumen L , during use or in a fully expanded state of the stent 100 , preferably has an opening cross section or area that is smaller than the opening area of the native atrio-ventricular heart valve that is , or which function is to be replaced by the heart valve prosthesis 1000 . The tubular stent 100 further has anchors , preferably distal anchors 170 , that may engage , or may be configured to engage , especially in an expanded state of the tubular stent 100 with native tissue , preferably of the native heart valve . Arranging, connecting and / or attaching interior valvular cusps 110 within the inner lumen L of the tubular stent 100 and / or arranging, connecting and / or attaching exterior valvular cusps 151 to 156 is represented by method step M2 .

[0114] In some embodiments of the method, method step M2 may encompas s arranging the interior valvular cusps 110 so as to form, e . g . , one cusp and preferably a second cusp and a third cusp, or any plurality of interior valvular cusps .

[0115] In a further method step M3 , at least one anchoring thread 130 is provided in order to be connected, directly or indirectly, to the tubular stent 100 , e . g . , by a first or free end of the respective thread or in order to be an integral part of the tubular stent 100 . This connection is preferably non-detachable so that the at least one anchoring thread 130 remains connected during use of the valve prosthesis 1000 after implantation .

[0116] In several embodiments of the method, at least one of the anchoring threads 130 may be provided in a length which is long enough to be or remains anchored or laced at a position outside of the left atrium, e . g . , at the intra-atrial septum, preferably at the Vena Cava Superior 403 , or more preferably further proximal at the Vena Jugularis 401 , after implantation of the heart valve prosthesis 1000 in the mitral valve of the left atrium, or outside of the right atrium, preferably at the Vena Cava Superior 403 , or more preferably further proximal at the Vena Jugularis 401 , after implantation of the heart valve prosthesis 1000 in the tricuspid valve of the right atrium . Thi s may be encompassed in method step M3 . Method step M4 represents connecting at least one, or several anchoring threads 130 to eyelets 160, respectively, that are provided at the stent 100 for this purpose.

[0117] In some embodiments, this step may encompass that some or all, or the majority of the anchoring threads 130 and / or of the eyelets 160 may be provided along the entire circumference, or only one section, e.g., one half of the circumference 183 of the through-opening of the brim or disc 180 or along, e.g., one half of the circumference of the tubular stent 100, respectively.

[0118] Arranging exterior valvular cusps 151 to 156 at an outer surface of the tubular stent 100 is represented by method step M6. In some embodiments of the method, method step M6 may encompass arranging and / or connecting the commissures 211 of the brim or truncated cone 180 to an exterior of the tubular stent 100, so as to form, e.g., a desired plurality of commissures 211 and exterior valvular cusps 151 to 156.

[0119] In several embodiments, these exterior valvular cusps 151 to 156 may be formed by attaching a disc or truncated cone 180 of material, preferably round in shape, having a central through opening 181, e.g., by sewing, to the tubular stent (100) , e.g., to a mesh thereof. The attaching of the disc 180 may be regarded as a separate method step M5.

[0120] In some embodiments of the method, the exterior valvular cusps 151 to 156 are being arranged so as to form at least one cusp, preferably a plurality of cusps, more preferably a first cusp, a second cusp, a third cusp. This is represented by method step M7.

[0121] Method step M8 represents covering the heart valve prosthesis 1000 with a sheath (not shown) such that the heart valve prosthesis , in particular the tubular stent 100 , the cusps 110 , 151 to 156 and / or some or all of anchors 170 are forced and / or maintained in a collapsed or crimped state thereof .

[0122] Optionally, the steps described above are carried out in the above-mentioned order, optionally with a time overlap between all or some of the steps , or simultaneously .

[0123] Fig . 8 shows an exemplary course of a method for inserting a heart valve prosthesis 1000 , preferably according to the present invention, into a heart , preferably into a j ugular vein 401 .

[0124] Reference is made to the description with regard to the preceding figures .

[0125] Method step S I represents providing a heart valve prosthesis 1000 , preferably according to the present invention .

[0126] Forwarding the heart valve prosthesis 1000 to the right atrium 405 in order to position the heart valve prosthesis 1000 within an opening 305 of a native , e . g . , a bicuspid or tricuspid, heart valve is represented by method step S2 . Thereby the heart valve prosthesis 1000 may be passed through a perforation 203 in an intra-atrial septum 201 , in particular in a collapsed or retracted state . The heart valve prosthesis 1000 in a collapsed or retracted state may be surrounded by a sheath or sheathed by some material for facilitating passing-through of the heart valve prosthesis 1000 to the intended implantation position .

[0127] Method step S3 represents retracting the material or sheath optionally surrounding the heart valve prosthesis 1000 in a collapsed state such that the heart valve prosthesis 1000 , in particular the tubular stent 100 , the interior and exterior cusps 110, 151 to 156 and / or some or all of the anchors 170, may expand and / or assume an expanded state.

[0128] Positioning and / or orienting the heart valve prosthesis 1000 by changing the length of one or more of the anchoring threads 130 is represented by method step S4. This may be done by manipulating the length of the individual anchoring threads 130, e.g., in order to tilt the heart valve prosthesis 1000, allowing the movement of the proximal end of the tubular stent 100 out of below the native heart valve to be replaced, e.g., out of the left ventricle 406 into the left atrium 404, e.g., moving the distal end of the stent out of the left ventricular outflow tract, e.g., in order to obtain or maintain, in an implanted state, an angle a between a longitudinal axis A of the heart valve prosthesis 1000 and a surface of the native mitral valve annulus 307 of the native heart, which may be preferably comprised in a range from zero to 90°, preferably 20 to 60°, most preferably in a range from 30 to 50°.

[0129] Method step S5 represents connecting, e. g., knotting, the anchoring threads 130 to a native structure or to native tissue, e.g., of the mammal.

[0130] List of reference numerals

[0131] 1000 heart valve prosthesis

[0132] 100 ( tubular ) stent

[0133] 110 interior valvular cusps

[0134] 130 anchoring threads

[0135] 151 first exterior valvular cusp

[0136] 152 second exterior valvular cusp

[0137] 153 third exterior valvular cusp

[0138] 154 forth exterior valvular cusp

[0139] 155 fi fth exterior valvular cusp

[0140] 156 sixth exterior valvular cusp

[0141] 158 free exterior valvular cusp edge

[0142] 160 eyelets

[0143] 170 anchors

[0144] 171 angle between anchor and ( tubular ) stent

[0145] 180 exterior brim, disc or truncated cone

[0146] 181 through opening

[0147] 182 external circumference of the brim

[0148] 183 circumference of the through-opening of the brim

[0149] 201 intra-atrial septum

[0150] 203 intra-atrial perforation

[0151] 211 commissures

[0152] 300 mitral valve

[0153] 300x lateral direction

[0154] 300y anterior posterior direction

[0155] 301 anterior mitral valve

[0156] 301a native anterior mitral valvular cusp

[0157] 302 posterior mitral valve

[0158] 302a native posterior mitral valvular cusp

[0159] 305 mitral valve incompetence

[0160] 307 mitral valve annulus 400 native heart

[0161] 401 Vena Jugularis ; j ugular vein

[0162] 403 Vena Cava Superior ; superior vena cava

[0163] 404 left atrium

[0164] 405 right atrium

[0165] 406 left ventricle

[0166] 407 right ventricle

[0167] Ml to M8 method steps of the method for producing a heart valve prosthesis

[0168] S I to S5 method steps of the method for inserting a heart valve prosthesis

[0169] L inner lumen of the tubular stent 100

[0170] A longitudinal axis of the tubular stent 100

[0171] B axis perpendicular to the surface of the native heart valve 300 or to the mitral annulus 307

Claims

ClaimsAtrio-ventricular heart valve prosthesis (1000) which is implantable into a mammal heart which comprises: a collapsible-expandable tubular stent (100) with an inner lumen, the inner lumen, during use or in a fully expanded state of the stent (100) , having an opening cross section or area, that is smaller than the opening area of the native atrio-ventricular heart valve that is to be replaced by the heart valve prosthesis (1000) , interior valvular cusps (110) arranged within the inner lumen of the tubular stent (100) that are closing the heart valve by resting against each other; and at least one anchoring thread (130) , directly or indirectly, connected to the tubular stent (100) .

2. Heart valve prosthesis (1000) according to claim 1, wherein, after implantation of the heart valve prosthesis (1000) , the at least one anchoring thread (130) is long enough to be or remain anchored or laced outside of the atria.

3. Heart valve prosthesis (1000) according to claim 2, wherein the heart valve prosthesis is implanted in a mitral valve of a left atrium of the mammal heart, and after implantation of the heart valve prosthesis (1000) , the at least one anchoring thread (130) is long enough to be or remain anchored or laced at a position outside of the left atrium.

4. Heart valve prosthesis (1000) according to claim 3, wherein after implantation of the heart valve prosthesis (1000) , the at least one anchoring thread (130) is long enough to be or remain anchored or laced at one of an intra-atrial septum (201) , a Vena Cava Superior (403) or a Vena Jugularis (401) of the mammal.

5. Heart valve prosthesis (1000) according to claim 2, wherein the heart valve prosthesis is implanted in a tricuspid valve of a right atrium of the mammal heart, and after implantation of the heart valve prosthesis (1000) , the at least one anchoring thread (130) is long enough to be or remain anchored or laced at a position outside of the right atrium.

6. Heart valve prosthesis (1000) according to claim 5, wherein after implantation of the heart valve prosthesis (1000) , the at least one anchoring thread (130) is long enough to be or remain anchored or laced at one of a Vena Cava Superior (403) or a Vena Jugularis (401) of the mammal .

7. Heart valve prosthesis (1000) according to claim 1, comprising eyelets (160) , or other sections that are part of the tubular stent (100) , or attached to it, directly or indirectly, for connecting at least one anchoring thread (130) to the tubular stent (100) , or connected to at least one anchoring thread (130) .

8. Heart valve prosthesis (1000) according to claim 1, wherein the interior valvular cusps (110) arranged within the inner lumen of the tubular stent (100) form a structure that does not open to allow upstream or downstream blood flow through the inner lumen of the tubular stent (100) .

9. Heart valve prosthesis (1000) according to claim 3, wherein the eyelets (160) are connected to a proximal section of the tubular stent (100) .

10. Heart valve prosthesis (1000) according to claim 3 or 4, wherein the anchoring threads (130) are connected to the eyelets (160) .

11. Heart valve prosthesis (1000) according to claim 1, further comprising: exterior valvular cusps (151 to 156) arranged at an outer surface of the tubular stent (100) , e.g., configured for closing the valve against native tissue, preferably against the native atrioventricular valve cusps during systole and for opening during diastole to allow blood flow from the atrium into the ventricle, in particular in an implanted state .

12. Heart valve prosthesis (1000) according to claim 6, wherein the exterior valvular cusps (151 to 156) are formed by a disc or truncated cone (180) of material, preferably round in shape, having a central through opening (181) , sections of the disc (180) being attached, e.g., sewed, to the tubular stent (100) , e.g., to a mesh thereof.

13. Heart valve prosthesis (1000) according to claim 1, further comprising: a plurality of, preferably distal, anchors (170) which are connected to, or part of, the tubular stent (100) , preferably at a distal end thereof.

14. Heart valve prosthesis (1000) according to claim 8, wherein the anchors (170) have a first end and a second end, wherein the first end is connected to the tubular stent (100) , and wherein the second end is a free end, opposite to the first end.

15. Heart valve prosthesis (1000) according to claim 1, wherein at least some of said distal anchors (170) are provided to assume a position forming an angle (171) between the distal anchors and the tubular stent (100) that is smaller than rectangular position with regard to a longitudinal axis A of the tubular stent (100) , preferably between 5° and 90°, more preferably between 10° and 30° when being without radial constraints, forces or pressure .

16. Heart valve prosthesis (1000) according to claim 1, wherein the anchoring threads (130) and / or of the eyelets (160) are provided along the entire circumference or alternatively only a portion of the circumference of the tubular stent (100) .

17. Heart valve prosthesis (1000) according to claim 1, wherein the interior valvular cusps are arranged so as to form one cusp and preferably a second cusp and a third cusp .

18. Heart valve prosthesis (1000) according to claim 1, wherein the exterior valvular cusps are arranged so as to form at least one cusp, preferably a plurality of cusps, more preferably a first cusp, a second cusp, a third cusp.

19. Heart valve prosthesis (1000) according to claim 1, wherein the heart valve prosthesis (1000) is an atrioventricular valve, a mitral heart valve or a tricuspid valve .

20. Heart valve prosthesis (1000) according to claim 1, at least in part covered by a sheath, the sheath forcing or maintaining the heart valve prosthesis ( 1000 ) in a collapsed state, in particular during displacement of the heart valve prosthesis (1000) to an intended implantation state .

21. Method for producing a heart valve prosthesis (1000) , preferably according to claim 1, which is implantable into a mammal heart the method comprising the steps : providing a collapsible-expandable tubular stent (100) with an inner lumen, the inner lumen, during use or in a fully expanded state of the stent (100) , preferably having an opening cross section or area, that is smaller than the opening area of the native atrio-ventricular heart valve of the mammal that is to be replaced by the heart valve prosthesis (1000) , arranging interior valvular cusps (110) within the inner lumen (L) of the tubular stent (100) ; providing for anchoring threads (130) that are, directly or indirectly, connected to the tubular stent (100) or integral part thereof.

22. Method according to claim 21, wherein, after implantation of the heart valve prosthesis (1000) , the anchoring threads(130) are long enough to be or remain anchored or laced outside of the atria.

23. Method according to claim 21, wherein, after implantation of the heart valve prosthesis (1000) in a mitral valve of a left atrium of the mammal heart, the anchoring threads (130) are long enough to be or remain anchored or laced outside of the left atrium.

24. Method according to claim 23, wherein the anchoring threads (130) are long enough to be or remain anchored or laced at one of an intra-atrial septum (201) , a Vena Cava Superior (403) or a Vena Jugularis (401) of the mammal.

25. Method according to claim 21, wherein, after implantation of the heart valve prosthesis (1000) in a tricuspid valve of a right atrium of the mammal heart, the anchoring threads (130) are long enough to be or remain anchored or laced outside of the right atrium.

26. Method according to claim 25, wherein the anchoring threads (130) are long enough to be or remain anchored or laced at one of a Vena Cava Superior (403) or a Vena Jugularis (401) of the mammal.

27. Method according to claim 21, wherein the anchoring threads (130) are connected to the eyelets (160) .

28. Method according to claim 21, further encompassing the step : arranging exterior valvular cusps (151 to 156) at an outer surface of the tubular stent (100) .

29. Method according to claim 21, wherein the exterior valvular cusps (151 to 156) are formed by attaching a disc or truncated cone of material (180) , preferably round in shape, having a central through opening (181) and free leaflet edge (158) , e.g., by sewing, a corresponding number of commissure (211) to the tubular stent (100) parallel to a longitudinal axis of the stent, e.g., to a mesh thereof or, e.g., commissural structure / strut .

30. Method according to claim 21, wherein the anchoring threads (130) and / or of the eyelets (160) are being provided along the entire circumference, or only a portion of the circumference of the tubular stent (100) .

31. Method according to claim 21, wherein the interior valvular cusps (110) are being arranged so as to form one cusp and preferably a second cusp and a third cusp.

32. Method according to claim 21, wherein the exterior valvular cusps (151 to 156) are being arranged so as to form at least one cusp, preferably a plurality of cusps, more preferably a first cusp, a second cusp, a third cusp.

33. Method according to claim 21, further comprising the step of covering the heart valve prosthesis (1000) such that some or all of the anchors (170) are forced in a collapsed state thereof by the sheath.

34. Method for inserting a heart valve prosthesis (1000) , in particular into the Jugular vein, of a mammal, comprising the steps: providing a heart valve prosthesis (1000) according to claim 1 and / or producing a heart valve prosthesis (1000) according to claim 21;forwarding the heart valve prosthesis (1000) to the right atrium in order to position the heart valve prosthesis (1000) within the opening of the native, e.g., tricuspid, valve; thereby passing the heart valve prosthesis (1000) through a perforation in the intra-atrial septum.

35. Method according to the preceding claim, further encompassing the step: retracting the sheath such that some or all of the anchors (170) may assume an expanded state thereof.

36. Method according to 25, further encompassing the step: positioning and / or orienting and / or tilting the heart valve prosthesis (1000) by changing the length of one or more of the anchoring threads (130) .

37. Method according to claim 25, further encompassing the step : connecting, e. g., knotting, the anchoring threads (130) to a native structure or of tissue, of the mammal .

Images