Valve prostheses and methods of making and using valve prostheses

Abstract

The present invention relates to an atrioventricular heart valve prosthesis implantable, for example, into the heart of a mammal. The heart valve prosthesis comprises a collapsible-expandable tubular stent having a lumen, preferably having an opening cross-section or area during use or in a fully expanded state of the stent that is smaller than an opening area of a native atrioventricular heart valve to be replaced by the heart valve prosthesis. The heart valve prosthesis further includes an inner valve tip disposed within the lumen of the tubular stent that closes the heart valve by resting against each other, an outer valve leaflet that closes against the native valve leaflet, and at least one anchor wire connected directly or indirectly to the tubular stent. The invention also relates to a method for manufacturing a heart valve prosthesis and to a method for inserting a heart valve prosthesis.

Description

Technical Field

[0001] This invention relates to a prosthetic valve, particularly for use in the heart, especially in a minimally invasive or percutaneous manner, and more specifically to a heart valve prosthesis constructed and suitable for replacing mammalian heart valves, most particularly atrioventricular valves, mitral valves, bicuspid valves, and / or tricuspid valves. The invention also relates to a method for manufacturing a heart valve prosthesis according to claim 21, and to a method for inserting, implanting, and / or anchoring a heart valve prosthesis according to claim 25. Summary of the Invention

[0002] The purpose of this invention is to describe in detail another heart valve prosthesis, a method for manufacturing a heart valve prosthesis, and a method for inserting, implanting, and / or anchoring a heart valve prosthesis.

[0003] The heart valve prostheses according to the invention, preferably atrioventricular heart valve prostheses, are designed, constructed and / or adapted for implantation into the heart of a mammal.

[0004] The heart valve prosthesis according to the invention comprises at least one, preferably collapsible-expandable, tubular stent having an inner lumen. The inner lumen preferably has an opening cross-section or area during use or in the fully expanded state of the stent, which is smaller than the opening area of ​​the native heart valve, for example, smaller than the opening area of ​​an atrioventricular heart valve to be replaced by a heart valve prosthesis in a mammal.

[0005] The heart valve prosthesis according to the invention further includes at least one, two, preferably three or four internal valve cusps or leaflets disposed within the lumen of a tubular stent to close the valve by resting against each other. The internal valve cusps or leaflets may be provided and / or configured, particularly in the implanted state, for closing the heart valve during cardiac systole and for opening during cardiac diastole by being pushed open to allow blood flow, for example, from the atria to the ventricles. The internal valve cusps or leaflets are preferably disposed at or near the proximal orifice of the tubular stent. The proximal orifice may be one of the two end orifices of the tubular stent. Alternatively, the internal valve cusps may be configured as a collapseable structure that does not open to prevent blood flow through the proximal orifice of the tubular stent, but instead blocks blood flow in both directions through the proximal orifice in the stent during cardiac systole and diastole.

[0006] The heart valve prosthesis according to the invention further includes at least one, two, preferably three or four anchoring lines, which are, or can be, directly or indirectly connected to a tubular stent, or are components of the tubular stent, for example, through a first end or free end of the respective line. The anchoring lines may be connected to the tubular stent, for example, preferably prior to implantation, preferably in a non-removable manner, and / or to the outer surface of the tubular stent to maintain connection with the valve prosthesis during use after implantation.

[0007] The method for manufacturing a heart valve prosthesis according to the invention, and particularly for manufacturing a heart valve prosthesis according to the invention, comprises at least the following steps: providing a preferably collapsible-expandable tubular stent having an inner lumen. The inner lumen of the tubular stent preferably has an opening cross-section or area during use or in the fully expanded state of the tubular stent, which is smaller than the opening area of ​​the native heart valve, for example, the opening area of ​​the native atrioventricular heart valve to be replaced by a heart valve prosthesis in a mammal.

[0008] The method for manufacturing a heart valve prosthesis according to the invention further includes or encompasses the following steps: arranging, securing, and / or attaching, e.g., suturing, and / or knotting at least one, two, preferably three, or four internal valve tips or leaflets within the lumen of a tubular stent. The internal valve tips or leaflets may be provided and / or configured, particularly in the implanted state, for closing the heart valve during cardiac systole and for opening during cardiac diastole by being pushed open to allow blood flow, for example, from the atria to the ventricles. Alternatively, the internal valve tips may be configured as a collapseable structure that does not open to prevent blood flow through the proximal aperture of the tubular stent, but instead blocks blood flow in both directions through the proximal aperture in the stent during cardiac systole and diastole.

[0009] The method for manufacturing a heart valve prosthesis according to the invention further includes or encompasses the step of providing at least one, two, preferably three, or four anchoring wires. The anchoring wires may be connected directly or indirectly to a tubular stent, for example, through a first end or free end of the respective wire, or may be part of the tubular stent. The anchoring wires may be connected to the tubular stent in a non-removable manner and / or to maintain connection during use of the valve prosthesis after implantation.

[0010] The method for inserting, implanting and / or anchoring a heart valve prosthesis according to the invention, particularly for inserting, implanting and / or anchoring a heart valve prosthesis according to the invention and / or for inserting, implanting and / or anchoring a heart valve prosthesis manufactured according to the manufacturing method according to the invention, includes at least the following steps: providing and / or manufacturing at least one heart valve prosthesis, particularly a heart valve prosthesis according to the invention.

[0011] Methods for inserting, implanting, and / or anchoring a heart valve prosthesis according to the invention further include or encompass the following steps: advancing the heart valve prosthesis into the right atrium of the heart to position the heart valve prosthesis within the opening of the native heart valve to be replaced, for example, within the opening of the native tricuspid or mitral valve.

[0012] Methods for inserting, implanting, and / or anchoring a heart valve prosthesis according to the invention further include or encompass the following steps: passing the heart valve prosthesis through a perforation in the interatrial septum, for example, a perforation in the septum between the left and right atria, so as to position the heart valve prosthesis, for example, within the opening of the native heart valve to be replaced, for example, within the opening of the native mitral valve.

[0013] According to embodiments of the present invention, some, several, or all of the following features may be included in any combination, unless those skilled in the art recognize that such a combination is technically impossible.

[0014] In all the following statements, the use of expressions such as “may be” or “may have” should be understood as being synonymous with “preferably is” or “preferably has”, respectively, and is intended to illustrate embodiments according to the invention.

[0015] Whenever numerical terms are mentioned herein, those skilled in the art should recognize or understand them as indications of a lower limit of a numerical value. Unless it is obviously contradictory to those skilled in the art, the description of, for example, “one” (also known as “a / an”) should be understood to cover “at least one”. This understanding is also equivalently covered by the invention to mean that numerical terms, such as “one” (also known as “a / an”), may alternatively mean “exactly one”, provided that this is technically obvious to those skilled in the art. Both understandings are covered by the invention and apply to all numerical terms used herein.

[0016] Whenever spatial information is mentioned herein, such as, for example, “top,” “bottom,” “left,” or “right,” those skilled in the art will understand that this refers to the arrangement in the accompanying drawings and / or in use. “Bottom” is closer to the Earth’s center or the bottom of the figure than “top.”

[0017] The terms “proximal” (from the Latin *proximus*, meaning “nearest”) and “distal” (from the Latin *distare*, meaning “farthest”) are used herein to describe portions or locations that are closer to or farther from the body. The “proximal end” of a heart valve prosthesis is defined herein as the end of the tubular stent that connects to or is attached to the tip of the internal valve. The opposite end of the stent is referred to herein as the “distal end” of the heart valve prosthesis. For a more detailed explanation, please refer to [link to relevant documentation].Figure 1 and Figure 5 The description.

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

[0019] Whenever an embodiment is mentioned herein, it is an exemplary embodiment of the invention and should not be construed as limiting.

[0020] While this document discloses that the subject matter of the invention includes one or more features in a certain embodiment, it also discloses that the subject matter of the invention expressly excludes this or those features in other embodiments, equally according to the invention, for example, in the sense of a disclaimer. Therefore, for each applicable embodiment mentioned herein, opposite embodiments are also disclosed, for example, expressed as negations.

[0021] When this article refers to programming or construction, these terms may be interchangeable in some embodiments.

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

[0023] In several embodiments of the heart valve prosthesis according to the invention, at least one, preferably multiple, anchoring lines are long enough to be anchored or secured or kept anchored or secured at a position on the lateral side of the left atrium after the heart valve prosthesis is implanted into the mitral valve of the left atrium, for example, at the interatrial septum, preferably at the superior vena cava, or more preferably closer to the jugular vein; or after the heart valve prosthesis is implanted into the tricuspid valve of the right atrium, anchored or secured or kept anchored or secured on the lateral side of the right atrium, preferably at the superior vena cava, or more preferably closer to the jugular vein.

[0024] In some embodiments, the heart valve prosthesis includes at least one or more orifices or other segments, which are preferably part of a tubular stent, or directly or indirectly attached to the tubular stent for connecting and / or attaching at least one anchoring line to the tubular stent, or for connecting and / or attaching to at least one anchoring line. At least one or more orifices or other segments preferably do not contribute to the collapsible-expandable properties of the tubular stent.

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

[0026] In some embodiments of heart valve prostheses, anchoring lines may optionally be directly or indirectly connected to and / or attached to the orifice in a detachable or non-detachable manner.

[0027] In several embodiments, the heart valve prosthesis according to the invention further includes an external valve tip or leaflet disposed, attached, and / or secured to the outer surface of a tubular stent.

[0028] Heart valve prostheses may include at least one, two, preferably three, or up to six external valve tips provided and configured to abut against native tissue, preferably against the tips of native atrioventricular valves, such as against the proximal foramina of the posterior and / or anterior mitral valve leaflets, preferably near the proximal foramen of a tubular stent, particularly in the implanted state and / or during cardiac systole. External valve tips may also be provided and configured to open, particularly in the implanted state and / or during cardiac diastole, to allow blood flow, for example, from the left atrium to the left ventricle.

[0029] In some embodiments, the tip of the external valve is formed from a disc or brim of a circular material, preferably a truncated cone with a central through-hole. Therefore, this shape may be referred to herein as a cone.

[0030] In several embodiments, sections of the disk, skirt, or cone, particularly sections of the outer circumference and / or the circumference of the through-hole, are attached, for example, to the tubular support, especially to the exterior or outer surface of the tubular support, for example, to the mesh of the tubular support. Sections of the circumference of the through-hole may preferably be attached to the proximal end of the tubular support. Sections of the outer circumference of the disk may preferably be attached to or along a section of the tubular support below the proximal end of the tubular support, preferably at a predetermined distance from the tubular support, for example, at the distal end of the tubular support and / or in any other section therebetween.

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

[0032] In several embodiments, the tubular support has one, at least one, or more anchors that are preferably distal.

[0033] In some embodiments, the distal anchors are preferably distributed uniformly or non-uniformly along the circumference of the distal end or end section of the tubular support, or only along a section of the circumference of the distal end of the tubular support, such as half, third, or quarter.

[0034] In several embodiments, the tubular stent has no distal end and / or no proximal anchor, particularly no anchor for directly or indirectly anchoring the heart valve prosthesis to the tissue of the native heart valve to be replaced.

[0035] In several embodiments, the anchor has a first end and a second end, wherein the first end is connected to the tubular support, and wherein the second end is 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, preferably at least one, some, or all of the distal anchors are provided to be positioned at an angle between the distal anchor and the tubular support, the angle being smaller than a rectangular position relative to the longitudinal axis A of the tubular support, preferably between 5° and 90° toward the distal end of the support, more preferably between 10° and 30°, when there is no radial constraint, force, or pressure applied, for example, by the sheath.

[0038] In several embodiments, most or all of the anchoring lines, anchors, and / or orifices of the heart valve prosthesis are exclusively provided along a preferred circumference, half, third, quarter, or any other segment of the circumference of the tubular stent or its end.

[0039] In some embodiments, the internal valve tips are arranged to form a first tip, preferably arranged within a tubular stent, and preferably a second and third tip, or any plurality of tips, such as anterior, posterior, and septal tips. With this arrangement, the internal valve tips allow fluid flow in one direction (referred to as the downstream direction), for example, when they open or are pushed apart from each other. However, fluid flow in the opposite direction (referred to as the upstream direction) closes or pushes the internal valve tips against each other, causing the prosthetic heart valve to mimic the (check valve) function of a natural valve.

[0040] In several embodiments, external valve tips are arranged to form at least one tip, preferably multiple tips, more preferably a first tip, a second tip, and a third tip. Multiple external valve tips may be positioned outside the tubular stent, and therefore there are no stent-associated mating portions. The external valve tips have a base connected to the stent orifice, flexible free leaflet edges (free-moving and not attached to the stent), and a corresponding number of commissures depending on the number of external valve tips, wherein the external valve tips are connected (e.g., sutured) to the stent commissure structure / strut parallel to the longitudinal axis of the stent. With this arrangement, when the heart valve prosthesis is implanted and the internal valve tips abut against each other, the flexible free leaflet edges open and close to regulate blood flow, causing the external valve tips to close against the native (disease) valve leaflets or tissue to prevent fluid or blood flow therebetween, for example, in the upstream direction, but they allow fluid flow in the opposite direction (referred to as the downstream direction), for example, when they open or are pushed towards the stent. Therefore, the tips of the external valves act as valve leaflets, allowing fluid or blood to flow in one direction, but not completely blocking blood flow or sealing the heart valve prosthesis like a cuff.

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

[0042] In several embodiments, the heart valve prosthesis according to the invention is preferably at least partially covered, or may be covered, by a sheath in its collapsed state. The sheath is designed to compress and retain some or all of the heart valve prosthesis, particularly the stent, the internal and external valve tips, and / or anchors, in their collapsed position, for example, until the intended implantation site of the heart valve prosthesis is reached.

[0043] In some embodiments, the surface area of ​​the tubular stent's cross-section, for example, the cross-sectional area perpendicular to the longitudinal axis A of the tubular stent, is preferably included in the extended state of the tubular stent within 0.3 cm². 2 Up to 5 cm 2 Within a certain range. The surface of the extended tubular stent cross section can be adapted or selected based on the expected surface of the native heart valve to be replaced, which may depend on the size, species, and / or weight of the corresponding mammal.

[0044] In several embodiments, when the 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 native heart valve or the surface of the mitral annulus of the native heart valve is included in the range of 0° to 90°, preferably 20° to 60°, and most preferably in the range of 30° to 50°.

[0045] The surface of the native heart valve can thus be defined by an axis 300y, referred to as the anteroposterior direction, and an axis 300x, referred to as the transverse direction, the two axes preferably being perpendicular to each other and perpendicular to axis B. The heart valve prosthesis can be implanted and / or secured obliquely or tilted relative to the surface of the native heart valve, particularly in the anteroposterior axis direction 300y and / or in the transverse axis direction 300x. That is, the plane perpendicular to the longitudinal axis A of the tubular stent can be oblique, or form a first angle with the anteroposterior axis 300y in the plane defined by axis B and the anteroposterior axis 300y, and / or the plane perpendicular to the longitudinal axis A of the tubular stent can be oblique, or form a second angle with the transverse axis 300x in the plane defined by axis B of the native heart valve 300 or mitral annulus 307 and the transverse axis 300x.

[0046] In some embodiments, the heart valve prosthesis, particularly the tip or leaflet of the internal valve, the tip or leaflet of the external valve, the eyelet, the anchor and / or the anchoring line, is made of biological material, or non-biological material, or artificial material.

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

[0048] Biomaterials can be, for example, organisms or tissues derived from animals, such as, for instance, pre-treated tissues from pigs, cattle, and / or horses, or organisms or tissues from mammals intended to receive heart valve prostheses. An advantage of using biomaterials is that the resulting heart valve prostheses do not require lifelong systemic anticoagulation, unlike artificial heart valve prostheses, which are prone to clotting and increase the risk of embolism.

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

[0050] In several embodiments, the heart valve prosthesis does not include or does not close a preferred external cuff, in particular an external cuff that is not constructed and / or arranged to abut against native tissue, such as against a native aortic valve sealing tubular stent.

[0051] In some embodiments, methods for inserting, implanting, and / or anchoring a heart valve prosthesis according to the invention may particularly include or encompass intravascular insertion of the heart valve prosthesis, for example, insertion into, for example, the jugular vein of a mammal.

[0052] In several embodiments of the method for manufacturing a heart valve prosthesis according to the invention, providing an anchoring line includes providing an anchoring line of sufficient length to reach, anchor, or fasten or remain anchored or fastened to a position lateral to the left atrium after the heart valve prosthesis is implanted into the mitral valve of the left atrium, for example, at the interatrial septum, preferably at the superior vena cava, or more preferably closer to the jugular vein; or after the heart valve prosthesis is implanted into the tricuspid valve of the right atrium, to reach, anchor, or fasten or remain anchored or fastened to a position lateral to the right atrium, preferably at the superior vena cava, or more preferably closer to the jugular vein.

[0053] In some embodiments of the method for manufacturing heart valve prostheses, anchoring lines are connected or are being connected, for example, knotted or sewn to the eyelets.

[0054] In several embodiments, the method for manufacturing a heart valve prosthesis further includes the steps of: arranging, securing, and / or connecting external valve tips at the outer surface of a tubular stent.

[0055] In some embodiments of the method for manufacturing a heart valve prosthesis, the external valve tip (151-156) is formed by attaching a sheet of preferably circular, preferably biocompatible material, such as a truncated cone, having a central through-hole and free leaflet edges, parallel to the longitudinal axis of a stent, such as a mesh or strut attached to a tubular stent, for example, by suturing a corresponding number of sutures. This material can be biological, non-biological, or artificial.

[0056] In several embodiments of the method for manufacturing a heart valve prosthesis, some, most, or all of the anchoring lines and / or orifices are provided or are being provided along the end of the tubular stent, preferably along the circumference of the distal end or end section of the tubular stent, or only along a section of the tubular stent, such as half, one-third, or one-quarter of the circumference of the distal end of the tubular stent.

[0057] In some embodiments of the method for manufacturing a heart valve prosthesis, the internal valve tip is or is being arranged, secured, and / or connected within a preferred tubular stent to form one tip, two tips, preferably three tips (e.g., anterior tip, posterior tip, septal tip), or any number of tips.

[0058] In some embodiments, the tip of the internal valve is alternatively made of a structure that blocks flow in both directions within the stent during cardiac systole and diastole.

[0059] In several embodiments of the method for manufacturing a heart valve prosthesis, external valve tips are being arranged to form at least one tip, preferably multiple tips, more preferably a first tip, a second tip, and a third tip. Multiple external valve tips may be positioned outside the tubular stent.

[0060] In some embodiments, the method of manufacturing a heart valve prosthesis further includes the step of: at least partially covering the heart valve prosthesis such that some or all of the stents, external and internal valve tips and / or anchors are, or can be, forced into their collapsed state. Such a covering may be exemplarily implemented by a sheath that preferably holds the collapsed heart valve prosthesis in its collapsed position, for example, until the intended implantation site of the heart valve prosthesis is reached.

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

[0062] In several embodiments, the method for inserting a heart valve prosthesis also includes the step of positioning and / or orienting the heart valve prosthesis, for example, by changing the length of one or more anchor lines. This can be achieved by manipulating the length of the individual anchor lines to tilt the heart valve prosthesis in all possible directions, thereby allowing the proximal end of the tubular stent to be removed from the native heart valve to be replaced, for example, removed from the left ventricle into the atrium.

[0063] In several embodiments, the purpose of tilting and oriented the heart valve prosthesis by means of anchor lines is to move the distal end of the stent away from the left ventricular outflow tract, thereby avoiding 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 stabilizing the heart valve prosthesis such that the angle α between the longitudinal axis A of the tubular stent and the axis B extending perpendicularly to the surface of the heart valve to be replaced, such as the surface of the mitral annulus of the native heart valve, is included in the range of 0° to 90°, preferably 20° to 60°, and more preferably in the range of 30° to 50°.

[0065] In several embodiments, the surface of the native heart valve may thus be defined by an axis 300y, referred to as the anterior-posterior direction, and an axis 300x, referred to as the lateral direction, the two axes preferably being perpendicular to each other and perpendicular to axis B. The heart valve prosthesis may be implanted and / or secured obliquely or tilted relative to the surface of the native heart valve, particularly in the anterior-posterior axis direction 300y and / or in the lateral axis direction 300x. That is, the plane perpendicular to the longitudinal axis A of the tubular stent may be oblique, or form a first angle with the anterior-posterior axis 300y in the plane defined by axis B and the anterior-posterior axis 300y, and / or the plane perpendicular to the longitudinal axis A of the tubular stent may be oblique, or form a second angle with the lateral axis 300x in the plane defined by axis B of the native heart valve 300 or mitral valve annulus 307 and the lateral axis 300x.

[0066] In some embodiments, the method for inserting a heart valve prosthesis also includes the step of connecting, for example, knotting, an anchoring wire to a native structure (e.g., an anchor) or native tissue of a mammal.

[0067] In several embodiments, particularly in the implanted state of the heart valve prosthesis, the angle α between the longitudinal axis A of the tubular stent and the axis B extending perpendicularly to the surface of the mitral annulus of the native heart valve is included in the range of 0° to 90°, preferably 20° to 60°, and more preferably in the range of 30° to 50°.

[0068] In some embodiments, delivery of the heart valve prosthesis at the implantation site can be minimally invasive, for example, percutaneously, transcavitarily, intercostally, and / or intravascularly, through openings in the jugular, subclavian, or femoral veins or other vessels, or through an opening at the apex of the left ventricle. The advantages of using such endovascular techniques are significant from a health, safety, and cost perspective. In particular, the minimally invasive nature of the mammalian body allows for at least a substantial reduction in the use of general anesthesia and / or the duration of the associated hospital or clinic stay.

[0069] According to some or all embodiments of the present invention, one, several or all of the advantages mentioned above and / or below may be present.

[0070] All the advantages that can be achieved using the method according to the invention can also be achieved without diminishing the advantages in certain embodiments of the invention with heart valve prostheses, and vice versa.

[0071] The invention is described below by way of example only with reference to the accompanying drawings. In the drawings, the same reference numerals denote the same or similar parts. Subsequently applicable: Attached Figure Description

[0072] Figure 1An exemplary embodiment of a purely exemplary mitral valve atrioventricular heart valve prosthesis according to the present invention is shown; Figure 1 a shows Figure 1 The internal valve tip of a prosthetic heart valve; Figure 2 Another exemplary embodiment of a purely exemplary mitral valve prosthesis according to the present invention is shown; Figure 3 Another exemplary embodiment of the purely exemplary mitral valve prosthesis according to the present invention during use is shown; Figure 3 a shows Figure 3 The angle between the anchor and the bracket in the embodiment; Figure 4 The image shows an implanted state as schematically represented. Figure 3 Examples of heart valve prostheses; Figure 5 Another embodiment of a heart valve prosthesis in an implanted state is shown, illustrating its position in the heart and at its anchoring point; Figure 6 An exemplary bicuspid mitral valve with insufficiency or dysfunction is shown above, into which a purely exemplary tricuspid or mitral valve prosthesis according to the invention is to be implanted. The x-axis shows the lateral direction (plane), and the y-axis shows the anterior-posterior direction (plane). Figure 6 a. From above, a purely exemplary tricuspid or mitral valve prosthesis with implantation according to the present invention is shown. Figure 6 The mitral valve; Figure 7 An exemplary process for manufacturing a heart valve prosthesis preferably according to the present invention is shown; and Figure 8 An exemplary procedure is shown for inserting, implanting, and / or anchoring, preferably according to the invention, a purely exemplary tricuspid or mitral valve prosthesis into the jugular vein of a dog. Detailed Implementation

[0073] Figure 1 An exemplary embodiment of an atrioventricular heart valve prosthesis 1000 according to the present invention is shown. This atrioventricular heart valve prosthesis is implantable and designed to be implanted, anchored, and / or secured into the heart of a mammal, preferably for replacing or substituting the valve function, particularly the check valve function, of a dysfunctional or defective native heart valve. The heart valve prosthesis 1000 may be a bicuspid or tricuspid valve. Figure 1In this figure, the heart valve prosthesis 1000 includes a tubular stent 100 and three internal valve tips 110, which are arranged in or within the lumen L of the tubular stent 100 at the proximal end of the stent 100. The tubular stent 100 may be collapsible-expandable. The heart valve prosthesis 1000 may be configured and / or arranged, in particular, to prevent backflow in one direction, especially from ventricular blood to atrium. In this figure and subsequent figures, the upper portion of the stent is referred to herein as “proximal” and the lower portion as “distal” (see relative to). Figure 5 (Description).

[0074] exist Figure 1 The example illustrates a purely optional collapsible-expandable tubular stent 100 with an inner lumen L in a fully expanded state, which can expand to this fully expanded state, for example, during use and / or after implantation at the implantation site (e.g., at a dysfunctional or defective native heart valve). The inner lumen L preferably has an opening cross-section or area smaller than the opening area of ​​the native heart valve, for example, the opening area of ​​a native atrioventricular heart valve in mammals, that is, its function to be replaced, repaired, or superseded by the heart valve prosthesis 1000.

[0075] In this example, three optional internal valve tips 110 are arranged, attached, secured, and / or fixed within, particularly inside, the lumen L of the tubular stent 100, or connected to, the lumen L, particularly the interior of the lumen. The internal valve tips 110 may preferably be arranged and / or attached to one end of the tubular stent 100, preferably at one end of the tubular stent 100 designed to prevent blood flow from the ventricle into the atrium after implantation, for example at the proximal opening or proximal foramen of the tubular stent 100.

[0076] Figure 1 a shows Figure 1 The internal valve tip 110 of the heart valve prosthesis 1000, for better overview, does not have a tubular stent 100.

[0077] exist Figure 1 In example a, there are three exemplary internal valve tips 110. The number of tips 110 is purely exemplary and should not be construed as limiting. The internal valve tips 110 are arranged and / or configured such that they close the heart valve prosthesis 1000 by resting against each other, for example, when fluid (e.g., blood) flows from the proximal end (in... Figure 1 The middle part (the top of the tubular stent 100) flows to the distal end (in Figure 1When the lower end of the tubular stent 100 is in the middle. The hollow arrow indicates the possible fluid flow from the proximal end to the distal end of the tubular stent 100. After implantation of the heart valve prosthesis 1000, where the proximal end opening enters, for example, atria 404, 405 (see Figure 4 ), and the distal end openings enter ventricles 406 and 407 (see Figure 4 ), will prevent the passage of ventricles 406 and 407 (see Figure 4 ) Entering atrium 404, 405 (see Figure 4 Blood flow from the atria 404 and 405 (see...) Figure 4 ) Entering ventricles 406, 407 (see Figure 4 Blood flow will be possible.

[0078] Figure 2 Another exemplary embodiment of the heart valve prosthesis 1000 according to the present invention is shown.

[0079] The heart valve prosthesis 1000 is designed and constructed, purely by way of example, as a tricuspid valve having three internal valve tips 110 disposed at one end of a tubular stent 100 located within a tubular stent 100. Figure 2 In the example, a biocompatible material is preferably used to attach the outer skirt or cone 180 to the tubular stent 100, particularly to the outside of the tubular stent 100, to form the external valve tips 151 to 156. Figure 2 Not shown in the image, see [link / reference]. Figure 3 , Figure 4 and Figure 6 a) The skirt or cone 180 may preferably be circular, preferably a truncated cone, and may preferably have a central annular opening 181 and a flexible, free leaflet edge 158. The hollow arrow indicates that the skirt 180 is attached to the support 100.

[0080] The outer skirt or cone 180 may optionally have a central through-hole 181, the circumference 183 of which may be attached or secured to the support of the tubular support 100 or include one end of the internal valve tip 110. The outer circumference of such a cone is referred to as the outer circumference 182 of the skirt or cone 180. The circumference of the through-hole 181 is referred to as the circumference 183 of the through-hole 181.

[0081] The skirt or cone 180 section may be folded downward along the longitudinal length or section of the tubular support 100, for example, folded along or on the outer surface of the tubular support 100, and may be attached or joined (e.g., sewn) to the tubular support 100, for example preferably at the joint 211 of the skirt or cone 180 and / or at other sections (e.g., at the circumference 183 of the through-hole 181), for example, attached or joined to the mesh of the tubular support, as shown in detail, for example, with respect to the following figures. The step of attaching or joining said section of the skirt or cone 180 to the tubular support 100 is described in... Figure 2 The middle part is schematically represented by four downward-curving arrows. (For example...) Figure 2 In the example, the skirt or cone 180 has four syndes 211 and four cusps 151, 152, 153, 154 (not visible). The skirt or cone syndes 211 are sewn to the support mesh (strap) along the longitudinal diameter of the support.

[0082] Figure 3 Another exemplary embodiment of the tricuspid valve prosthesis 1000 according to the invention, during use and / or in a fully deployed state, is shown.

[0083] Refer to the accompanying figures and descriptions. The differences or additions to these figures are mentioned below only.

[0084] Heart valve prostheses 1000, particularly tubular stents 100, include perforations 160, which preferably do not contribute to the collapsible-expandable properties of the tubular stent 100. Figure 3 In the example, the orifice 160 is radially positioned at the upper edge of the tubular stent 100, thereby surrounding the tubular stent at nearly equal and / or predetermined, preferably equal distances. This position can also be defined radially between the inner valve tip 110 and the outer valve tips 151 to 156.

[0085] exist Figure 3 In the example, the heart valve prosthesis 1000 has six exemplary orifices 160, which are arranged at approximately equal distances around the circumference of the end or upper edge of the tubular stent 100. However, the number and location of the orifices 160 are purely exemplary and should not be construed as limiting.

[0086] Eyelet 160 may be intended to be a connection point or part of a connection for anchoring at least one or more wires 130. Figure 3 Not shown in the image, see [link / reference]. Figure 4 and Figure 5 (in order to secure them to the tubular support 100, or to connect them to the tubular support).

[0087] Instead of the eyelet 160, other sections of the tubular support 100 may be directly or indirectly attached to or connected to the anchor line 130.

[0088] In some embodiments, the eyelet 160 may be connected to the tubular support 100 and / or to one or more proximal anchors, respectively. This is in Figure 3 Not shown in the image.

[0089] exist Figure 3 In the example, a plurality of distal anchors 170 are shown at the distal end of the tubular support 100, which are connected to or are part of the tubular support.

[0090] Anchor 170 has a first end and a second end, wherein the first end is directly or indirectly connected to the tubular support 100 in a detachable or non-detachable manner, and wherein the second end is a free end opposite to the first end, preferably radially outwardly swinging.

[0091] At least some of the distal anchors 170 are provided to be positioned at an angle 171 between the distal anchor and the tubular support 100, which is smaller than a rectangular position relative to the longitudinal axis A of the tubular support 100, preferably between 5° and 90°, more preferably between 10° and 30°, when there is no radial constraint, force or pressure applied, for example by the sheath.

[0092] Anchor 170 is preferably designed such that during use (not shown, see...) Figure 4 In particular, in the expanded state of the tubular stents 100, they can use their free ends to engage with the tissue of the native valve and / or the chordae tendineae and / or the mitral annulus, so that the heart valve prosthesis 1000 can be stabilized or fixed within the native valve.

[0093] Figure 4 The image shows the implanted mitral valve within the mitral annulus 307 of the native mitral valve 300. Figure 3 An example of a heart valve prosthesis 1000.

[0094] There are three anchor lines 130, which are connected directly or indirectly to the tubular support 100, for example, through a first end of the respective line 130 connected to a corresponding eyelet 160. Alternatively, two or more anchor lines 130 may be connected to a single or identical eyelet 160. The number of anchor lines 130, their connection to the tubular support 100, and their connection to the eyelets 160 are purely exemplary and should not be construed as limiting.

[0095] Optionally, in this example, only half (e.g., the right half) or a segment of the circumference (observer's line of sight) of the tubular stent 100 is provided with eyelets 160 for connection to the anchoring line 130. This may facilitate the necessary and / or intended tilt or skew orientation of the heart valve prosthesis 1000 within the native mitral valve 300 or mitral annulus 307, which may be expected and / or necessary for the heart valve prosthesis 1000 to function properly. Furthermore, it may be intended to move the distal portion of the valve prosthesis away from the left ventricular outflow tract to avoid left ventricular outflow tract stenosis. The tilt or skew orientation can be defined as angle α. Angle α can be defined as the angle formed between the longitudinal axis A of the tubular stent 100 and an axis B perpendicular to the surface of the native heart valve or perpendicular to the surface surrounded by the native mitral annulus 307.

[0096] The connection between the exemplary three anchoring lines 130 and the tubular stent 100 is preferably non-removable, or may be configured such that the connection remains unchanged during the use of the valve prosthesis after implantation.

[0097] Anchor wire 130 is guided through the interatrial septum 201 via an intraatrial perforation 203 so as to be secured to the atrium (not shown, see [link]). Figure 5 The outside of ).

[0098] Figure 4 As shown, the anchor 170 can engage with the tissue of the native valve (e.g., mitral valve) 300 during use, exemplarily here engaging with the native posterior mitral valve tip 302a of the posterior mitral valve 302 and / or the native anterior mitral valve tip 301a of the anterior mitral valve 301.

[0099] Figure 5 Another embodiment of the heart valve prosthesis 1000 according to the invention, implanted in, for example, heart 400, is shown in an implanted state, illustrating an exemplary location and an exemplary corresponding anchorage in the native heart 400.

[0100] Refer to the description relative to the previous diagram.

[0101] exist Figure 5 In the example, a heart valve prosthesis 1000 was implanted, wherein its proximal end is oriented cephalicly and its distal end is oriented caudally.

[0102] Anchoring lines 130 are anchored or secured at the jugular vein 401 of the heart 400 to the lateral side of the left atrium 404. They are preferably long enough to remain and / or be present after the implantation of the heart valve prosthesis 1000 between the left ventricle 406 and the left atrium 404.

[0103] As an alternative to the illustrated embodiment, some or all of the anchor lines 130 may be anchored or secured at the interatrial septum or at any location outside the left atrium 404, for example, not too far away, for example, at the superior vena cava 403.

[0104] Figure 6 The image above shows a heart valve prosthesis 1000 according to the invention, into which a dysfunctional or impaired native mitral valve 300 is to be implanted.

[0105] Figure 6 As can be seen, within the native mitral annulus 307, the tips 301a and 302a of the native anterior mitral valve do not close properly. Therefore, during the closure of the tips 301a and 302a of the native anterior and posterior mitral valves, the ostium 305 remains unchanged, resulting in valvular insufficiency.

[0106] Figure 6 A diagram shown above depicts a heart valve prosthesis 1000 implanted according to the invention. Figure 6 The mitral valve is 300.

[0107] Refer to the description relative to the previous diagram.

[0108] exist Figure 6 In embodiment a, the heart valve prosthesis 1000 exemplarily displays three internal mitral valve tips 110 and six external mitral valve tips 151, 152, 153, 154, 155, and 156. Similar to the description herein, the heart valve prosthesis 1000 is anchored between the native anterior mitral valve tip 301a and the native posterior mitral valve tip 302a. For simplicity, the eyelet 160 and anchoring line 130 have been omitted.

[0109] Figure 7 An exemplary process is shown for manufacturing a heart valve prosthesis 1000, preferably according to the invention, which can be implanted into a native heart 400.

[0110] Refer to the description relative to the previous diagram.

[0111] Method step M1 indicates providing a collapsible-expandable tubular stent 100 having an inner lumen L. The inner lumen L preferably has an opening cross-section or area during use or in the fully expanded state of the stent 100, which is smaller than the opening area of ​​the original atrioventricular heart valve to be replaced by the heart valve prosthesis 1000 or whose function is to be replaced by the heart valve prosthesis. The tubular stent 100 also has anchors, preferably distal anchors 170, which, particularly in the expanded state of the tubular stent 100, can be engaged with or can be configured to engage with the original tissue, preferably the original tissue of the original heart valve.

[0112] Method step M2 indicates that an internal valve tip 110 and / or an external valve tip 151 to 156 are arranged, connected and / or attached within the lumen L of the tubular stent 100.

[0113] In some embodiments of the method, method step M2 may cover arranging the internal valve tip 110 to form, for example, a tip and preferably a second and a third tip, or any plurality of internal valve tips.

[0114] In another method step M3, at least one anchoring wire 130 is provided to be directly or indirectly connected to the tubular stent 100, for example, through a first end or free end of the respective wire, or to become part of the tubular stent 100. This connection is preferably non-removable, such that at least one anchoring wire 130 remains connected during the use of the valve prosthesis 1000 after implantation.

[0115] In several embodiments of the method, at least one of the anchoring lines 130 may be provided of a length sufficient to anchor, fasten, or remain anchored or fastened to a position lateral to the left atrium after the heart valve prosthesis 1000 is implanted into the mitral valve of the left atrium, for example, at the interatrial septum, preferably at the superior vena cava 403, or more preferably closer to the jugular vein 401; or after the heart valve prosthesis 1000 is implanted into the tricuspid valve of the right atrium, anchored, fastened, or remained anchored or fastened to a position lateral to the right atrium, preferably at the superior vena cava 403, or more preferably closer to the jugular vein 401. This may be encompassed in method step M3.

[0116] Method step M4 indicates that at least one or more anchor lines 130 are connected to eyelets 160 respectively, for which eyelets are provided at the bracket 100.

[0117] In some embodiments, this step may include providing some or all of the anchor lines and / or eyelets 130 and / or eyelets 160 along the entire circumference 183 of the through hole of the skirt or disc 180 or only a segment (e.g., a half) or along a half of the circumference of, for example, the tubular support 100.

[0118] Method step M6 indicates the arrangement of external valve tips 151 to 156 on the outer surface of the tubular stent 100. In some embodiments of the method, method step M6 may encompass arranging and / or connecting the ferrules 211 of the skirt or truncated cone 180 to the outside of the tubular stent 100 to form, for example, the desired plurality of ferrules 211 and external valve tips 151 to 156.

[0119] In several embodiments, these external valve tips 151 to 156 can be formed by attaching, for example by stitching, a disc or truncated cone 180 having a central through-hole 181 made of a material preferably circular in shape to a tubular stent (100), such as to a mesh of the tubular stent. The attachment of the disc 180 can be considered as a separate method step M5.

[0120] In some embodiments of this method, external valve tips 151 to 156 are arranged to form at least one tip, preferably multiple tips, more preferably a first tip, a second tip, and a third tip. This is indicated by method step M7.

[0121] Method step M8 means covering the heart valve prosthesis 1000 with a sheath (not shown) such that some or all of the heart valve prosthesis, particularly the tubular stent 100, valve tips 110, 151 to 156 and / or anchors 170, are forced and / or held in their collapsed or curled state.

[0122] Optionally, the steps described above may be performed in the order mentioned above, where there may be time overlap between all or some of the steps, or simultaneously.

[0123] Figure 8 An exemplary procedure is shown for inserting a heart valve prosthesis 1000, preferably according to the invention, into the heart, and preferably into the jugular vein 401.

[0124] Refer to the description relative to the previous diagram.

[0125] Method step S1 indicates providing a heart valve prosthesis 1000 preferably according to the present invention.

[0126] Method step S2 indicates that the heart valve prosthesis 1000 is advanced into the right atrium 405 to position it within the opening 305 of the native heart valve (e.g., a bicuspid or tricuspid valve). This allows the heart valve prosthesis 1000, particularly in a collapsed or retracted state, to pass through the perforation 203 in the interatrial septum 201. The collapsed or retracted heart valve prosthesis 1000 may be sheathed or encased in some material to facilitate its passage to the intended implantation site.

[0127] Method step S3 represents retracting the material or sheath optionally surrounding the collapsed heart valve prosthesis 1000, such that some or all of the heart valve prosthesis 1000, particularly the tubular stent 100, the internal and external valve tips 110, 151 to 156 and / or the anchors 170 can be expanded and / or presented in an expanded state.

[0128] Method step S4 indicates that the heart valve prosthesis 1000 is positioned and / or oriented by changing the length of one or more anchor lines 130. This can be achieved by manipulating the length of the individual anchor lines 130, for example, to tilt the heart valve prosthesis 1000 so as to allow the proximal end of the tubular stent 100 to be moved out of the native heart valve to be replaced, for example, out of the left ventricle 406 and into the left atrium 404, for example, to move the distal end of the stent out of the left ventricular outflow tract, for example, to obtain or maintain an angle α between the longitudinal axis A of the heart valve prosthesis 1000 and the surface of the native mitral valve annulus 307 of the native heart in the implanted state. This angle can preferably be included in the range of 0° to 90°, preferably 20° to 60°, and most preferably in the range of 30° to 50°.

[0129] Method step S5 means connecting, for example, knotting the anchor line 130 to, for example, a mammalian native structure or tissue.

[0130] List of reference numerals 1000 Heart valve prosthesis 100 (Tube) stent 110 Internal valve tip 130 Anchor line 151 First external valve tip 152 The tip of the second external valve 153 The tip of the third external valve 154 Fourth external valve tip 155 Fifth external valve tip 156 The tip of the sixth external valve 158 Free external valve tip edge 160 eyelets 170 Anchoring components 171 Angle between anchor and (tubular) support 180 External skirt, disc or truncated cone 181 Through hole 182 outer circumference of the skirt hem 183 circumference of the through hole in the skirt hem 201 Atrial Spectrum 203 Intraatrial perforation 211 Union 300 Mitral valve 300x Horizontal direction 300y Forward and backward directions 301 anterior mitral valve 301a The original anterior mitral valve tip 302 Posterior mitral valve 302a The original posterior mitral valve tip 305 Mitral valve insufficiency 307 Mitral valve annulus 400 Original Heart 401 jugular vein (Vena Jugularis) 403 Superior vena cava (Vena Cava Superior) 404 left atrium 405 right atrium 406 Left ventricle 407 Right ventricle M1 to M8 Method steps for manufacturing heart valve prostheses S1 to S5 Method steps for inserting a heart valve prosthesis L The inner lumen of the tubular stent 100 A Longitudinal axis of tubular stent 100 B Perpendicular to the surface of the native heart valve 300 or the axis perpendicular to the mitral valve annulus 307

Claims

1. An atrioventricular heart valve prosthesis (1000) implantable in the heart of a mammal, said atrioventricular heart valve prosthesis comprising: A collapsible and expandable tubular stent (100) having an inner lumen, the lumen having an opening cross-section or area during use or in the fully expanded state of the stent (100), the opening cross-section or area being smaller than the opening area of ​​the original atrioventricular heart valve to be replaced by the heart valve prosthesis (1000). The internal valve tips (110) of the heart valve, arranged within the lumen of the tubular stent (100) and positioned abutting against each other to close the valve; and At least one anchor line (130) is directly or indirectly connected to the tubular support (100).

2. The heart valve prosthesis (1000) according to claim 1, wherein, After the implantation of the heart valve prosthesis (1000), the at least one anchoring line (130) is long enough to anchor or fasten or remain anchored or fastened to the outside of the atrium.

3. The heart valve prosthesis (1000) according to claim 2, wherein, The heart valve prosthesis is implanted into the mitral valve of the left atrium of the mammalian heart, and after the heart valve prosthesis (1000) is implanted, the at least one anchoring line (130) is long enough to anchor or fasten or remain anchored or fastened at a position on the outside of the left atrium.

4. The heart valve prosthesis (1000) according to claim 3, wherein, After the implantation of the heart valve prosthesis (1000), the at least one anchoring line (130) is long enough to anchor or fasten or remain anchored or fastened to one of the atrial septum (201), superior vena cava (403), or jugular vein (401) of the mammal.

5. The heart valve prosthesis (1000) according to claim 2, wherein, The heart valve prosthesis is implanted into the tricuspid valve of the right atrium of the mammalian heart, and after the heart valve prosthesis (1000) is implanted, the at least one anchoring line (130) is long enough to anchor or fasten or remain anchored or fastened at a position on the outside of the right atrium.

6. The heart valve prosthesis (1000) according to claim 5, wherein, After the implantation of the heart valve prosthesis (1000), the at least one anchoring line (130) is long enough to anchor or fasten or remain anchored or fastened to one of the superior vena cava (403) or jugular vein (401) of the mammal.

7. The heart valve prosthesis (1000) according to claim 1, wherein the heart valve prosthesis includes an orifice (160) or other segment that is part of the tubular stent (100) or is directly or indirectly attached to the tubular stent for connecting at least one anchor line (130) to the tubular stent (100) or to at least one anchor line (130).

8. The heart valve prosthesis (1000) according to claim 1, wherein, The tip (110) of the internal valve arranged within the lumen of the tubular stent (100) forms a structure that does not open, thereby preventing upstream or downstream blood flow through the lumen of the tubular stent (100).

9. The heart valve prosthesis (1000) according to claim 3, wherein, The eyelet (160) is connected to the proximal section of the tubular support (100).

10. The heart valve prosthesis (1000) according to claim 3 or 4, wherein, The anchor line (130) is connected to the eyelet (160).

11. The heart valve prosthesis (1000) according to claim 1, wherein the heart valve prosthesis further comprises: The external valve tip (151156) disposed on the outer surface of the tubular stent (100), particularly in the implanted state, is configured, for example, to close the valve against native tissue, preferably against the native atrioventricular valve tip, during cardiac systole, and to open during cardiac diastole to allow blood flow from the atrium into the ventricle.

12. The heart valve prosthesis (1000) according to claim 6, wherein, The external valve tip (151156) is formed from a disc or truncated cone (180) of a material preferably circular in shape, having a central through-hole (181), and sections of the disc (180) are attached, for example, to the tubular support (100), for example, to a mesh attached to the tubular support.

13. The heart valve prosthesis (1000) according to claim 1, wherein the heart valve prosthesis further comprises: Preferably, a plurality of anchors (170) are connected at the distal end of the tubular support (100) to the tubular support or a portion thereof.

14. The heart valve prosthesis (1000) according to claim 8, wherein, The anchor (170) has a first end and a second end, wherein the first end is connected to the tubular support (100), and wherein the second end is a free end opposite to the first end.

15. The heart valve prosthesis (1000) according to claim 1, wherein, At least some of the distal anchors (170) are provided to be positioned to form an angle (171) between the distal anchor and the tubular support (100), the angle being smaller than a rectangular position relative to the longitudinal axis A of the tubular support (100), preferably between 5° and 90°, more preferably between 10° and 30° when there is no radial constraint, force or pressure.

16. The heart valve prosthesis (1000) according to claim 1, wherein, The anchor line (130) and / or the eyelet (160) are provided along the entire circumference of the tubular support (100) or alternatively only a portion thereof.

17. The heart valve prosthesis (1000) according to claim 1, wherein, The internal valve tips are arranged to form a valve tip, as well as a preferred second and third valve tip.

18. The heart valve prosthesis (1000) according to claim 1, wherein, The external valve tips are arranged to form at least one tip, preferably multiple tips, more preferably a first tip, a second tip, and a third tip.

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

20. The heart valve prosthesis (1000) according to claim 1, wherein the heart valve prosthesis is at least partially covered by a sheath, the sheath particularly during the displacement of the heart valve prosthesis (1000) to the intended implantation state, forcing or holding the heart valve prosthesis (1000) in a collapsed state.

21. A method for manufacturing a heart valve prosthesis (1000) preferably implantable in a mammalian heart according to claim 1, the method comprising the steps of: A collapsible and expandable tubular stent (100) with an inner lumen is provided, the lumen preferably having an opening cross-section or area during use or in the fully expanded state of the stent (100), the opening cross-section or area being smaller than the opening area of ​​the original atrioventricular heart valve of the mammal to be replaced by the heart valve prosthesis (1000). An internal valve tip (110) is arranged within the lumen (L) of the tubular stent (100). An anchor line (130) is provided, which is directly or indirectly connected to the tubular support (100) or is a component of the tubular support.

22. The method according to claim 21, wherein, After the heart valve prosthesis (1000) is implanted, the anchoring line (130) is long enough to anchor or fasten or remain anchored or fastened to the outside of the atrium.

23. The method according to claim 21, wherein, After the heart valve prosthesis (1000) is implanted into the mitral valve of the left atrium of the mammalian heart, the anchoring line (130) is long enough to anchor or fasten or remain anchored or fastened to the outside of the left atrium.

24. The method according to claim 23, wherein, The anchoring line (130) is long enough to anchor or fasten or remain anchored or fastened to one of the atrial septum (201), superior vena cava (403), or jugular vein (401) of the mammal.

25. The method according to claim 21, wherein, After the heart valve prosthesis (1000) is implanted into the tricuspid valve of the right atrium of the mammalian heart, the anchoring line (130) is long enough to anchor or fasten or remain anchored or fastened to the outside of the right atrium.

26. The method of claim 25, wherein, The anchoring line (130) is long enough to anchor or fasten or remain anchored or fastened to one of the superior vena cava (403) or jugular vein (401) of the mammal.

27. The method according to claim 21, wherein, The anchor line (130) is connected to the eyelet (160).

28. The method of claim 21, further comprising the steps of: External valve tips (151156) are arranged on the outer surface of the tubular stent (100).

29. The method according to claim 21, wherein, The external valve tip (151156) is formed by attaching a disc or truncated cone of material (180) preferably circular in shape to the tubular stent (100) by stitching together a corresponding number of sutures (211), for example, to a mesh or suture structure / staff of the tubular stent.

30. The method according to claim 21, wherein, The anchor line (130) and / or the eyelet (160) are provided along the entire circumference or only a portion of the circumference of the tubular support (100).

31. The method according to claim 21, wherein, The internal valve tip (110) is arranged to form a valve tip, as well as a preferred second valve tip and a third valve tip.

32. The method according to claim 21, wherein, The external valve tip (151156) is arranged to form at least one tip, preferably multiple tips, more preferably a first tip, a second tip, and a third tip.

33. The method according to claim 21, further comprising the following steps: The sheath covers the heart valve prosthesis (1000) such that some or all of the anchors (170) are forced into their collapsed state by the sheath.

34. A method for inserting a heart valve prosthesis (1000), particularly into the jugular vein of a mammal, the method comprising the steps of: Provide a heart valve prosthesis (1000) according to claim 1, and / or manufacture a heart valve prosthesis (1000) according to claim 21. The heart valve prosthesis (1000) is advanced into the right atrium so as to position the heart valve prosthesis (1000) within the opening of the native valve, such as the tricuspid valve; This allows the heart valve prosthesis (1000) to pass through a perforation in the interatrial septum.

35. The method according to the preceding claim, further comprising the steps of: The sheath is retracted so that some or all of the anchors (170) can be in their expanded state.

36. The method of claim 25, further comprising the steps of: The heart valve prosthesis (1000) is positioned and / or oriented and / or tilted by changing the length of one or more of the anchor lines (130).

37. The method of claim 25, further comprising the steps of: The anchoring line (130) is connected, for example, knotted, to the native structure or tissue of the mammal.

Images