Heart valve prosthesis

Abstract

The present invention relates to a heart valve prosthesis for implantation into the heart of a patient, and to a delivery system for introducing such heart valve prosthesis into the heart of a patient.

Description

Heart valve prosthesis

[0001] The present invention relates to a heart valve prosthesis for implantation into the heart of a patient, and to a delivery system for introducing such heart valve prosthesis into the heart of a patient.TECHNICAL FIELD

[0002] The present invention relates to the field of heart valve replacement or support, especially to the replacement or support of a heart valve comprising a degenerated annuloplasty ring or an annular calcification anatomy, especially for implantation into a mitral valve comprising a degenerated annuloplasty ring or mitral annular calcification.BACKGROUND

[0003] Native heart valves are one-way valves, which means they allow the blood flow to pass in the direction of the physiological blood flow but not backwards. Many diseases or risk factors as for example age and gender are known to be linked to a malfunction of a heart valve. Such malfunction is usually associated with a regurgitation, i.e. blood passing the heart valve backwards in a non-physiological direction. Especially when persisting over a prolonged time, such regurgitation may aggravate and become life-threatening.

[0004] Furthermore, malfunction of one heart valve may cause intermediary a malfunction of other heart valves. Especially a malfunction of the mitral valve, may lead to an obstruction of the aortic valve due to a leaflet of the mitral valve being forced into a disadvantageous position within the ventricle. This is known to occur especially in case of a transcatheter mitral valve replacement (TMVR).

[0005] In the past years, techniques for the implantation of heart valve prostheses of varying shape, with the objective of replacing or supporting the native heart valve have been developed. It is common for most of those techniques and the respective heart valve prostheses that a sufficient anchoring of the heart valve prosthesis has to be achieved, while still allowing the surrounding tissue of the heart to perform, i.e., to adapt to the dynamic movement of the heart during the cardiac cycle.

[0006] In particular, the anchoring of the heart valve prosthesis at the ventricular side of the native heart valve may be challenging since most anchoring techniques rely on expansion of an anchoring structure against the native annulus and the leaflets, such that the annulus may dilatate and / or, depending on the anatomy of the patient, a leaflet may be forced to extend within the right ventricular outflow tract or left ventricular outflow tract, respectively.

[0007] US 11,633, 278, B2 discloses a mitral heart valve prosthesis comprising a stent frame comprising an outwardly flared distalmost, an intermediate, and an outwardly flared proximal- most row of cells, wherein every second distal vertex of a row of cells of the intermediate row adjacent to the proximalmost row is not connected to the proximalmost row. This allows the proximalmost row to be large, thus improving the anchoring. The distalmost row in contrast is disclosed to be smaller as compared to the proximalmost row, to avoid obstruction of the left ventricular outflow tract. Therefore, barbs are provided at the distalmost row of cells to further improve anchoring. However, such barbs may cause damage to the surrounding tissue and the small size of the distalmost row enhances the risk of displacement of the prosthesis, for example in case of progressive annulus dilatation.

[0008] EP 3 760 165 A1 discloses a mitral heart valve prosthesis comprising a stent frame comprising an outwardly flared distalmost, an intermediate, and an outwardly flared proximalmost row of cells. To avoid obstruction of the left ventricular outflow tract, the stent frame is constructed asymmetrically such that at the side adjacent to the left ventricular outflow tract, no cells or cells being smaller as compared to the other cells of the distalmost row are provided. However, relinquishing or minimizing cells of the distalmost row destabilizes the anchoring and thus enhances the risk of displacement.

[0009] US 2014 / 0046426 A1 discloses a mitral valve prosthesis comprising multiple U-shaped arms extending evenly distributed from the distal end of the valve prosthesis and grasping around the native valve's leaflets to position the valve prosthesis. Also, a corresponding delivery system is disclosed. However, when using the leaflet to anchor the prosthesis, the native leaflet may be forced into a position obstructing the left ventricular outflow tract and / or the anatomy of the patient.

[0010] Thus, it is an object of the present invention to provide a heart valve prosthesis allowing for sufficient anchoring, minimal risk of tissue injury or obstruction of a ventricular outflow tract, and correction of a disadvantageous anatomy in this respect.SUMMARY OF THE INVENTION

[0011] In an aspect of the invention, the object is solved by a heart valve prosthesis for implantation into the heart of a patient, wherein the heart valve prosthesis is expandable between a radially crimped configuration and a radially expanded configuration, and includes a lumen, having a luminal side and an abluminal side, a distal end and a proximal end, and a central longitudinal axis defined perpendicularly through the lumen, and comprising a stent frame and a valve element being attached to the stent frame within the lumen, wherein the stent frame is formed from a plurality of adjacent cells arranged in circumferential rows, wherein the plurality of cells comprises a proximalmost row of cells at the proximal end and a distalmost row of cells at the distal end, and at least one intermediate row of cells, arranged between the proximalmost row and distalmost row of cells, wherein each cell of the at least one intermediate row of cells has substantially the shape of a rhombus with a proximal vertex and an distal vertex, being opposite to one another in the longitudinal direction of the stent frame, and with a right vertex and a left vertex, being opposite to one another in the circumferential direction of the stent frame, wherein a right vertex of a first cell in the at least one intermediate row of cells is connected to a leftvertex of second cell adjacent to the first cell of the intermediate row of cells in the circumferential direction, and wherein each cell of the proximalmost row of cells is formed by two struts each having a first end and a second end, the first ends of the two struts being connected to one another forming a proximalmost vertex, and each end of the second ends of the two struts being connected to a proximal vertex of a cell of the intermediate row of cells lying adjacent to the proximalmost row of cells, such, that one proximal vertex / vertices of a cell of the intermediate row of cells that lies adjacent to the proximalmost row of cells is unconnected with and free from a connection with the second ends, and wherein each cell of the distalmost row of cells is formed by two struts each having a first end and a second end, the first ends of the two struts being connected to one another forming an distalmost vertex, and each end of the second ends of the two struts being connected to a distal vertex of a cell of the intermediate row of cells lying adjacent to the distalmost row of cells, such, that one distal vertex / vertices of a cell of the intermediate row of cells that lies adjacent to the distalmost row of cells is unconnected with and free from a connection with the second ends.

[0012] In a second aspect, the problem is solved by a heart valve prosthesis for implantation into the heart of a patient, wherein the heart valve prosthesis is expandable between a radially crimped configuration and a radially expanded configuration, and includes a lumen, having a luminal and an abluminal side, a distal end and a proximal end, and a central longitudinal axis defined perpendicularly through the lumen, and comprising a stent frame and a valve element being attached to the stent frame within the lumen, wherein the stent frame is formed from a plurality of adjacent cells arranged in circumferential rows, wherein the plurality of cells comprises a proximalmost row of cells at the proximal end and a distalmost row of cells at the distal end, and at least one intermediate row of cells, arranged between the proximalmost row and distalmost row of cells, and wherein the heart valve prosthesis further comprisesa deflecting element for keeping a native leaflet from obstructing ventricular outflow, wherein the deflecting element is formed by a stent wire arm, which is self-expandable and can be expanded from a crimped configuration into an expanded configuration, and which comprises a first end, a first portion, an intermediate portion, a second portion and a second end, which stent wire arm, via its first end, is attached to the stent frame, forming an attachment point, and protrudes with the first portion, the intermediate portion, the second portion and the second end beyond the distal end of the heart valve prosthesis, with the second end being unattached to the stent frame, and wherein the first portion, the intermediate portion and the second portion are configured to form the deflecting element for accommodating the native leaflet, and wherein a distance between the intermediate portion and the central longitudinal axis of the heart valve prosthesis is smaller than a distance between the attachment point and the central longitudinal axis of the heart valve prosthesis.

[0013] In a third aspect, a delivery system for introducing a heart valve prosthesis into the heart of a patient is disclosed, wherein the delivery system comprises a heart valve prosthesis as described above and below, and also a delivery catheter, the delivery catheter comprising a retractable outer sheath, that, in a state where the heart valve prosthesis is loaded onto the delivery catheter, holds the heart valve prosthesis in a crimped state, wherein the delivery system is configured, such, that in the loaded state and crimped state of the heart valve prosthesis, the first portion and the second portion of the stent wire arm are not angled relative to each other, and the intermediate portion is not curved; and wherein upon retraction of the outer sheath, first the second end of the stent wire arm is exposed, then the second portion is folded outwardly until a preset radius of the intermediate portion is reached and the deflecting element is formed, and, when the second portion is folded outwardly, and after full exposure of the stent wire arm, the deflecting elementdeflects towards the central longitudinal axis, such, that a distance between the intermediate portion and the central longitudinal axis of the heart valve prosthesis is smaller than a distance between the first end’s attachment point and the central longitudinal axis of the heart valve prosthesis, preferably wherein the deflecting element is angled relative to and towards the distal end in an angle of between 30° and 85°.DEFINITIONS

[0014] The term “stent frame” throughout herein is to be understood, as generally in the field, as a net or grid of stent wires forming a generally tubular framework for providing a certain degree of rigidity and flexibility to and for supporting an optional prosthetic material covering the stent frame at least partially.

[0015] Accordingly, the term “cells” throughout herein is to be understood, as generally in the field, as a through-hole within the stent-frame, i.e., the meshes of the net or grid forming the stent frame including the stent wires forming the respective mesh.

[0016] Throughout herein, the direction indication “proximal” refers to a direction oriented away from a ventricle of a heart, while the direction indication “distal” refers to a direction oriented towards or into a ventricle.

[0017] Throughout herein, the term “vertex” is to be understood as an extreme point. Such extreme point may be formed by an acute or obtuse angle or by a curvature. Accordingly, a vertex may appear sharply pointed (“peaky”) or may be smooth or only slightly curved. This definition applies, for example, to the corner points of a rhombus, regardless of their angular or curved configuration.

[0018] The heart valve prosthesis is expandable between a radially crimped configuration and a radially expanded configuration. As will be clear to the skilled person, a heart valve prosthesis can be implanted minimal-invasively by use of a delivery catheter. Thus, a radially crimped configuration of a heart valve prosthesis is a configuration the heart valve prosthesis has when the heart valve prosthesis is loaded onto such delivery catheter. Aradially expanded configuration of a heart valve prosthesis in contrast is a configuration the heart valve prosthesis has when the heart valve prosthesis was implanted into the heart of a patient.

[0019] A distal vertex / vertices of a cell of the intermediate row of cells that lies adjacent to the distalmost row of cells or proximalmost row of cells, respectively, being unconnected with and free from a connection with the second ends is to be understood such that the respective proximal or distal vertex is not connected to a second end or second end other than intermediary, i.e. , for example, via a left or right vertex.

[0020] As used herein, the term “valve element” refers to a component of the heart valve prosthesis that is configured to regulate unidirectional blood flow through the lumen of the prosthesis. The valve element is attached to the stent frame within the lumen and is operable between an open configuration, in which blood flow is permitted in the forward direction (typically from the ventricle to the artery), and a closed configuration, in which backflow is substantially prevented. The valve element may include one or more leaflets formed from biological tissue or synthetic material and may assume any suitable shape or design, including trileaflet or bileaflet configurations, adapted to mimic the function of a native heart valve.PREFERRED EMDBOIMENTS OF THE INVENTION

[0021] In a preferred embodiment of both of the above mentioned first and second aspect of the heart valve prosthesis of the invention, each end of the second ends of the two struts forming the proximalmost row of cells is connected to a proximal vertex of a cell of the intermediate row of cells lying adjacent to the proximalmost row of cells, such, that every second proximal vertex / vertices of a cell of the intermediate row of cells that lies adjacent to the proximalmost row of cells is unconnected with and free from a connection with the second ends.

[0022] Advantageously, this leads to higher formability of the proximalmost row of cells and lower resistance during the expansion process.

[0023] In a preferred embodiment of both of the above mentioned first and second aspect of the heart valve prosthesis of the invention, each end of the second ends of the two struts forming the distalmost row of cells is connected to a distal vertex of a cell of the intermediate row of cells lying adjacent to the distalmost row of cells, such, that every second distal vertex / vertices of a cell of the intermediate row of cells that lies adjacent to the distalmost row of cells is unconnected with and free from a connection with the second ends.

[0024] Advantageously, this leads to higher formability of the distalmost row of cells and lower resistance during the expansion process.

[0025] In a preferred embodiment of both of the above mentioned first and second aspect of the heart valve prosthesis of the invention, the proximalmost row of cells and the distalmost row of cells are outwardly flared, respectively, with respect to the lumen of the heart valve prosthesis.

[0026] This advantageously yields sufficient anchoring of the heart valve prosthesis in the native annulus.

[0027] In a preferred embodiment of both of the above mentioned first and second aspect of the heart valve prosthesis of the invention, the heart valve prosthesis comprises between 1 and 5 intermediate row(s) of cells, i.e. , 1 , 2, 3, 4 or 4 intermediate row(s) of cells, preferably 3.

[0028] Such selection advantageously yields a sufficiently rigid stent frame to further sustain anchoring of the heart valve prosthesis by causing friction to withstand forces the heart valve prosthesis is exerted to when implanted, while ensuring sufficient flexibility to perform.

[0029] In a preferred embodiment of both of the above mentioned first and second aspect of the heart valve prosthesis of the invention, the stent frame is at least partially self-expanding and / or at least partially plastically deformable.

[0030] The stent frame being at least partially self-expandable advantageously facilitates implantation since it is not to be expanded completely by the surgeon.

[0031] The stent frame being at least partially plastically deformable advantageously allows to adjust the heart valve prosthesis during implantation to the individual anatomy of the patient.

[0032] The stent frame being partially self-expanding and partially plastically deformable allows to provide parts of the stent frame known to require adjustment to the individual anatomy of the patient with in this respect advantageous plastic deformability while providing parts of the stent frame not requiring such adjustment with the easy-to-handle self-expandability.

[0033] In a preferred embodiment of both of the above mentioned first and second aspect of the heart valve prosthesis of the invention, the stent frame is plastically deformable via inflation of a balloon, i.e., the stent frame is balloon-expandable.

[0034] In a preferred embodiment of both of the above mentioned first and second aspect of the heart valve prosthesis of the invention, the heart valve prosthesis is for implantation into or use in the treatment of a diseased native heart valve.

[0035] In a preferred embodiment of both of the above mentioned first and second aspect of the heart valve prosthesis of the invention, wherein the proximalmost row of cells and distal- most row of cells are outwardly flared, the heart valve prosthesis is for implantation into or use in the treatment of a heart valve comprising a degenerated surgical annuloplasty ring or a diseased native heart valve, wherein the diseased native valve is preferably an annular calcified heart valve, most preferably an annular calcified mitral heart valve. In such case, the stent frame is advantageous since an annuloplasty ring, even though degenerated, or an annular calcification provides additional grip for the proximalmost and distal- most rows of cells, both being outwardly flared.

[0036] In a preferred embodiment of both of the above mentioned first and second aspect of the heart valve prosthesis of the invention, the stent frame is made from one piece.

[0037] This advantageously enhances longevity and stability of the heart valve prosthesis.

[0038] According to a second aspect, as mentioned above, the problem is solved by a heart valve prosthesis for implantation into the heart of a patient, wherein the heart valve prosthesis is expandable between a radially crimped configuration and a radially expanded configuration, and includes a lumen, having a luminal and an abluminal side, a distal end and a proximal end, and a central longitudinal axis defined perpendicularly through the lumen, and comprising a stent frame and a valve element being attached to the stent frame within the lumen, wherein the stent frame is formed from a plurality of adjacent cells arranged in circumferential rows, wherein the plurality of cells comprises a proximalmost row of cells at the proximal end and a distalmost row of cells at the distal end, and at least one intermediate row of cells, arranged between the proximalmost row and distalmost row of cells, and wherein the heart valve prosthesis further comprises a deflecting element for keeping a native leaflet from obstructing ventricular outflow, wherein the deflecting element is formed by a stent wire arm, which is self-expandable and can be expanded from a crimped configuration into an expanded configuration, and which comprises a first end, a first portion, an intermediate portion, a second portion and a second end, which stent wire arm, via its first end, is attached to the stent frame, forming an attachment point, and protrudes with the first portion, the intermediate portion, the second portion and the second end beyond the distal end of the heart valve prosthesis, with the second end being unattached to the stent frame, and wherein the first portion, the intermediate portion and the second portion are configured to form the deflecting element for accommodating the native leaflet, andwherein a distance between the intermediate portion and the central longitudinal axis of the heart valve prosthesis is smaller than a distance between the attachment point and the central longitudinal axis of the heart valve prosthesis.

[0039] The heart valve prosthesis of aspects of the invention is expandable between a radially crimped configuration and a radially expanded configuration. As will be clear to the skilled person, a heart valve prosthesis can be implanted minimal-invasively by use of a delivery catheter. Thus, a radially crimped configuration of a heart valve prosthesis is a configuration the heart valve prosthesis has when the heart valve prosthesis is loaded onto such delivery catheter. A radially expanded configuration of a heart valve prosthesis in contrast is a configuration the heart valve prosthesis has when the heart valve prosthesis was implanted into the heart of a patient.

[0040] According to the invention, a “deflecting element” is an element, which is formed and designed such that it is suitable and can keep or hold - i.e. , deflect - a native leaflet from obstructing ventricular outflow. According to the invention, the deflecting element is formed by a stent wire arm. The stent wire arm, preferably, can be a single stent wire, wherein the first end of the stent wire arm is attached to the stent frame and the second end of the stent wire arm is not attached to the stent frame. The stent wire arm can also be a stent wire forming a loop such that both ends of the looped stent wire are connected to the stent frame, resulting in one or two attachment points. The end designated as the “first end” is preferably one of these two attached ends. The stent wire arm can also be a branched stent wire. Alternatively, the stent wire arm can be a framework or network of multiple stent wires connected via at least one attachment point to the stent frame.

[0041] The stent wire arm protrudes with the first portion, the intermediate portion, the second portion and the second end beyond the distal end of the heart valve prosthesis.

[0042] This advantageously reduces interference between the deflecting element and the valve element and minimizes or avoids a risk of transvalvular leakage.

[0043] The distance between the intermediate portion and the central longitudinal axis being smaller than the distance between the attachment point and the central longitudinal axis is advantageous since this way, the native leaflet accommodated by the deflecting element, is deflected by the deflecting element into a position allowing efficient blood flow through the heart valve into which the heart valve prosthesis is implanted as well as through another adjacent heart valve, wherein without the deflecting element, the blood flow through such other heart valve would be impaired by a disadvantageous position of said native leaflet.

[0044] As will be clear to the skilled person, the distance between the intermediate portion and the central longitudinal axis and the distance between the attachment point and the central longitudinal axis depends on the individual anatomical requirements of the patient.

[0045] In a preferred embodiment of the invention, the deflecting element is formed such, that the intermediate portion is curved with a preset radius, effecting that the first portion generally expands into the distal direction or away from the distal end, and the second portion generally expands into the proximal direction or towards the distal end.

[0046] By such configuration the deflecting element advantageously can grasp or extend around at least a part of the free edge of the native leaflet allowing to influence the position of the leaflet by means of the deflecting element, especially by deflecting the deflecting element. Thus, the deflecting element is advantageously configured for safely accommodating the native leaflet.

[0047] In a preferred embodiment, the preset radius is from 1 mm to 10 mm, with the outer ranges included, respectively.

[0048] Such radius advantageously allows that the leaflet is safely grasped or slightly clamped but not clamped such that the tissue of the leaflet is injured.

[0049] In a preferred embodiment of the invention, the deflecting element is angled relative to and towards the distal end in an angle of between 30° and 85°, preferably 50° to 85°C,with the outer ranges included, respectively. In a further preferred embodiment, the deflecting element is angled relative to and towards the distal end in an angle of between about 30° and 60°, preferably about 35° to 55°C, preferably about 40° to 50°, and more preferably about 42° to 48°, with the outer ranges included, respectively. In a preferred embodiment, the angle is about 45°C.

[0050] Such angle 0 advantageously allows to sufficiently deflect the native leaflet out of an outflow tract of another heart valve without obstructing instead the heart valve prosthesis itself.

[0051] In a preferred embodiment, the first portion and second portion are angled in an angle a of between about 120° to 210°, of about 140° to about 190°, of about 160° to about 180°, with the outer ranges included, respectively.

[0052] Such angle a advantageously allows to sufficiently accommodate the native leaflet by the deflecting element as to securely hold or clamp it.

[0053] In a preferred embodiment of the invention, the first end of the stent wire arm is attached to the abluminal side or luminal side, or to a distalmost point of the distalmost row of cells, or a combination of the aforementioned.

[0054] This reduces the extension of the deflecting element within or through the lumen or in between the heart valve prosthesis and the surrounding tissue as compared to an attachment to the proximalmost point of the proximalmost row of cells, which advantageously reduces interference of the deflecting element with the valve element and the risk of para- valvular leakage.

[0055] In a preferred embodiment of the invention, the stent wire arm, more preferably at least the intermediate portion and / or the first end of the stent wire arm, or the stent wire arm as such, is at least partially or in total made from a shape-memory material, preferably from Nitinol. This advantageously provides self-expandability and / or deflectability of the deflecting element.

[0056] In a preferred embodiment of the aspects of the invention, the stent frame and the stent wire arm are made from one piece. This advantageously smoothens the surface at the attachment point reducing risk of injury of the surrounding tissue and improves stability and longevity of the attachment.

[0057] In a preferred embodiment, each cell of the at least one intermediate row of cells has substantially the shape of a rhombus with a proximal vertex and an distal vertex, being opposite to one another in the longitudinal direction of the stent frame, and with a right vertex and a left vertex, being opposite to one another in the circumferential direction of the stent frame, wherein a right vertex of a first cell in the at least one intermediate row of cells is connected to a left vertex of second cell adjacent to the first cell of the intermediate row of cells in the circumferential direction, and wherein each cell of the proximalmost row of cells is formed by two struts each having a first end and a second end, the first ends of the two struts being connected to one another forming an proximalmost vertex, and each end of the second ends of the two struts being connected to a proximal vertex of a cell of the intermediate row of cells lying adjacent to the proximalmost row of cells, such, that one proximal vertex / vertices of a cell of the intermediate row of cells that lies adjacent to the proximalmost row of cells is unconnected with and free from a connection with the second ends, and wherein each cell of the distalmost row of cells is formed by two struts each having a first end and a second end, the first ends of the two struts being connected to one another forming an distalmost vertex, and each end of the second ends of the two struts being connected to a distal vertex of a cell of the intermediate row of cells lying adjacent to the distalmost row of cells, such, that one distal vertex / vertices of a cell of the intermediate row of cells that lies adjacent to the distalmost row of cells is unconnected with and free from a connection with the second ends.

[0058] A distal vertex / vertices of a cell of the intermediate row of cells that lies adjacent to the distalmost row of cells or proximalmost row of cells, respectively, being unconnected with and free from a connection with the second ends is to be understood such that therespective proximal or distal vertex is not connected to a second end or second end other than intermediary, i.e. , for example, via a left or right vertex.

[0059] This embodiment advantageously yields a sufficient anchoring of the heart valve prosthesis, to which anchoring the deflecting element does not contribute.

[0060] In a preferred embodiment of the aspects of the invention, each end of the second ends of the two struts forming the proximalmost row of cells is connected to a proximal vertex of a cell of the intermediate row of cells lying adjacent to the proximalmost row of cells, such, that every second proximal vertex / vertices of a cell of the intermediate row of cells that lies adjacent to the proximalmost row of cells is unconnected with and free from a connection with the second ends.

[0061] This advantageously yields a uniform and enhanced flexibility of the cells of the proximalmost row of cells. Such enhanced flexibility improves adjustability of the stent frame to the individual anatomical needs of the patient.

[0062] In a preferred embodiment, each end of the second ends of the two struts forming the dis- talmost row of cells is connected to a distal vertex of a cell of the intermediate row of cells lying adjacent to the distalmost row of cells, such, that every second distal vertex / vertices of a cell of the intermediate row of cells that lies adjacent to the distalmost row of cells is unconnected with and free from a connection with the second ends.

[0063] This advantageously yields a uniform and enhanced flexibility of the cells of the distalmost row of cells. Such enhanced flexibility improves adjustability of the stent frame to the individual anatomical needs of the patient. Preferably, the patient is a mammal, preferably a human.

[0064] In a preferred embodiment of the invention, the stent frame is made from one piece. This advantageously enhances longevity and stability of the heart valve prosthesis.

[0065] In a preferred embodiment of the invention, the proximalmost row of cells and the distal- most row of cells are outwardly flared, respectively, with respect to the lumen of the heart valve prosthesis.

[0066] This advantageously yields sufficient anchoring of the heart valve prosthesis in the native annulus.

[0067] In a preferred embodiment of the invention, the heart valve prosthesis comprises between 1 and 5 intermediate row(s) of cells, i.e. , 1, 2, 3, 4, or 5 intermediate row(s) of cells, preferably 3.

[0068] Such selection advantageously yields a sufficiently rigid stent frame to further sustain anchoring of the heart valve prosthesis by causing friction to withstand forces the heart valve prosthesis is exerted to when implanted, while ensuring sufficient flexibility to perform.

[0069] In a preferred embodiment of the aspects of the invention, the valve element comprises from one to four leaflets, i.e., 1 , 2, 3 or 4 leaflets.

[0070] In a preferred embodiment of the invention, the stent frame is at least partially self-expanding and / or at least partially plastically deformable.

[0071] The stent frame being at least partially self-expandable advantageously facilitates implantation since it is not to be expanded completely by the surgeon.

[0072] The stent frame being at least partially plastically deformable advantageously allows to adjust the heart valve prosthesis during implantation to the individual anatomy of the patient.

[0073] The stent frame being partially self-expanding and partially plastically deformable allows to provide parts of the stent frame known to require adjustment to the individual anatomy of the patient with in this respect advantageous plastic deformability while providing partsof the stent frame not requiring such adjustment with the easy-to-handle self-expandability.

[0074] In a preferred embodiment of the invention, the heart valve prosthesis is plastically deformable via inflation of a balloon, i.e., the heart valve prosthesis is balloon-expandable.

[0075] In a preferred embodiment of the invention, the first end of the stent wire arm is attached to a distal vertex of a cell of the intermediate row of cell lying adjacent to the distalmost row of cells, preferably to a distal vertex to which at least one second end of a strut forming the distalmost row of cells is connected.

[0076] Such attachment is advantageous in that it avoids the deflecting element to unnecessarily extend within the lumen, which may cause interference with the valve element, or in between the native valve tissue and the heart valve prosthesis, which may cause paravalvu- lar leakage.

[0077] In a preferred embodiment of the aspects of the invention, the heart valve prosthesis is a mitral valve prosthesis.

[0078] This is advantageous, because the aortic valve and the mitral valve are close to each other and angled to each other such that the aortic valve may be easily at least partially obstructed by the anterior leaflet of the mitral valve. Thus, the heart valve prosthesis allows by means of the deflecting element to deflect the anterior mitral leaflet such that no obstruction of the aortic valve occurs.

[0079] In a preferred embodiment of the aspects of the invention, the heart valve prosthesis is for implantation into or use in the treatment of a diseased native heart valve.

[0080] In a preferred embodiment of the aspects of the invention, the heart valve prosthesis is for implantation into or use in the treatment of an annular calcified heart valve.

[0081] The heart valve prosthesis is advantageous for implantation into or use in the treatment of an annular calcified heart valve since an annular calcified heart valve provides sufficient grip for the heart valve prosthesis.

[0082] In a preferred embodiment of the aspects of the invention, the heart valve prosthesis is for implantation into or use in the treatment of an annular calcified mitral valve.

[0083] The heart valve prosthesis of the invention is advantageous for implantation into or use in the treatment of an annular calcified mitral valve since in mitral annular calcification, the anterior leaflet of the native mitral valve is known to be prone to be in a position that is disadvantageous for a transcatheter mitral valve replacement (TMVR), i.e. hinders efficient blood flow through the left ventricular outflow tract or the aortic valve after implantation of heart valve prostheses of prior art, respectively.

[0084] In a preferred embodiment of the invention, the heart valve prosthesis is for implantation into or use in the treatment of a heart valve comprising a degenerated surgical annulo- plasty ring. In such case, the stent frame is advantageous since an annuloplasty ring, even though degenerated, provides additional grip for the proximalmost and distalmost rows of cells, both being outwardly flared.

[0085] As mentioned above, in a third aspect, the objective is solved by a delivery system for introducing a heart valve prosthesis into the heart of a patient, wherein the delivery system comprises a heart valve prosthesis according to the second aspect of the invention, a delivery catheter, and a retractable outer sheath that, in a state where the heart valve prosthesis is loaded onto the delivery catheter, holds the heart valve prosthesis in a crimped state, wherein the delivery system is configured, such, that in the loaded state and crimped state of the heart valve prosthesis, the first and the second portion of the stent wire arm are not angled relative to each other, and the intermediate portion is not curved; and whereinupon retraction of the outer sheath, first the second end of the stent wire arm is exposed, then the second portion is folded outwardly until a preset radius of the intermediate portion is reached and the deflecting element is formed, and, when the second portion is folded outwardly, and after full exposure of the stent wire arm, the deflecting element deflects towards the central longitudinal axis, such, that a distance between the intermediate portion and the central longitudinal axis of the heart valve prosthesis is smaller than a distance between the first end’s attachment point and the central longitudinal axis of the heart valve prosthesis.

[0086] Such delivery system advantageously allows to easily accommodate a native leaflet by the deflecting element and to correct a disadvantageous anatomy, i.e., a disadvantageous position of the respective native leaflet.

[0087] In a preferred embodiment of the invention, the deflecting element deflects until being angled relative to and towards the distal end in an angle p of between about 30° and 85°, preferably of between about 50° to 85°, with each of the outer ranges included, respectively. In a further preferred embodiment, the deflecting element is angled relative to and towards the distal end in an angle p of between about 30° and 60°, preferably about 35° to 55°C, preferably about 40° to 50°, and more preferably about 42° to 48°, with the outer ranges included, respectively. In a preferred embodiment, the angle is about 45°C.

[0088] In a preferred embodiment of the invention, the outer sheath is retracted in the proximal direction.

[0089] This advantageously allows transseptal delivery of the heart valve prosthesis.

[0090] In a preferred embodiment of the invention, the delivery catheter further comprises a pullwire, wherein the pull-wire, in the state where the heart valve prosthesis is loaded onto the delivery catheter, is releasably attached to the second end and exerts a tensile force onto the stent wire arm, andthe outer sheath is retracted in the distal direction, and the second portion is folded outwardly upon reduction of the tensile force exerted by the pull-wire, and after the second portion was folded outwardly, the second end is detached from the pull-wire.

[0091] This advantageously allows transapical delivery of the heart valve prosthesis.

[0092] In a fourth aspect of the invention, a method for releasing / deploying a heart valve prosthesis according to the second aspect from a delivery catheter, comprising the use of the delivery system.

[0093] Such method advantageously allows to easily accommodate a native leaflet by the stent wire arm and to correct a disadvantageous anatomy, i.e., a disadvantageous position of the respective native leaflet.

[0094] In a preferred embodiment of the invention, the method is a method for treatment of a heart valve having a degenerated surgical annuloplasty ring or a diseased native heart valve, wherein the diseased native valve is preferably an annular calcified heart valve, most preferably an annular calcified mitral heart valve.BRIEF DESCRIPTION OF THE FIGURES

[0095] Fig. 1 shows an embodiment of a heart valve prosthesis of the invention in a side-view.

[0096] Fig. 2 shows another embodiment of the heart valve prosthesis of the invention in a sideview.

[0097] Fig. 3 shows the heart valve prosthesis shown in Fig. 2 implanted into the heart of a patient.

[0098] Fig. 4 shows an embodiment of a delivery system of the invention, being used for transseptal introduction / delivery of the heart valve shown in Fig. 2 into the heart of a patient.

[0099] Fig. 5 shows an embodiment of a delivery system of the invention, being used for trans- apical introduction / delivery of the heart valve shown in Fig. 2 into the heart of a patient.

[0100] Fig. 6 shows a detail of the delivery system shown and used in Fig. 5 in more detail.DETAILLED DESCRIPTION OF PREFERRED EMBODIMENTSHeart valve prosthesis according to the first aspect

[0101] Fig. 1 shows an embodiment of a heart valve prosthesis 10 according to the invention in a side-view.

[0102] The heart valve prosthesis 10 comprises a proximal end 12, a distal end 14, a central longitudinal axis 62, a stent frame 48, and a valve element 49 and includes a lumen 16.

[0103] The heart valve prosthesis 10 is expandable between a radially crimped configuration and a radially expanded configuration. Fig. 1 shows a radially expanded configuration.

[0104] The proximal end 12 forms a first opening allowing a liquid to pass. When in use, the first opening allows blood to pass.

[0105] The distal end 14 forms a second opening allowing a liquid to pass. When in use, the second opening allows blood to pass.

[0106] The lumen 16 comprises a luminal side 58 and an abluminal side 60 and extends tubularly through the stent frame 48 such that a liquid can enter the lumen 16 via the proximal end 12, pass the lumen 16, and exit the lumen 16 via the distal end 14.

[0107] The lumen 16 extends tubularly through the heart valve prosthesis 10 such that a liquid can enter the lumen 16 via the proximal end 12, pass the lumen 16, and exit the lumen 16 via the distal end 14.

[0108] The luminal side 58 faces from the stent frame 48 towards the lumen 16. The luminal side 58 can be at least partially covered by a prosthetic material.

[0109] The abluminal side 60 faces from the stent frame 48 away from the lumen 16. The abluminal side 60 can be at least partially covered by a prosthetic material.

[0110] The central longitudinal axis 62 is defined perpendicularly through the lumen 16.

[0111] The stent frame 48 is formed from a plurality of adjacent cells. The plurality of adjacent cells is arranged in circumferential rows.

[0112] As will be clear to the skilled person, at least some of the cells can be sealed, for example by a prosthetic material.

[0113] The plurality of adjacent cells comprises a proximalmost row of cells 18, a distalmost row of cells 20, and at least one intermediate row of cells 22.

[0114] The at least one intermediate row of cells 22 is arranged in between the proximalmost row of cells 18 and the distalmost row of cells 20.

[0115] In a preferred embodiment, 3 intermediate rows of cells 22 are provided. In other preferred embodiments, 1 , 2, 4, or 5 intermediate rows of cells 22 can be provided.

[0116] Each cell of the at least one intermediate row of cells 22 has substantially the shape of a rhombus with a proximal vertex 40, a distal vertex 42, a right vertex 44, and a left vertex 46. The proximal vertex 40 and the distal vertex 42 are opposite to one another in the longitudinal direction of the stent frame 10. The right vertex 44 and the left vertex 46 are opposite to one another in the circumferential direction of the stent frame 48. A right vertex 44 of a first cell is connected to a left vertex 46 of second cell adjacent to the first cell in the circumferential direction of the stent frame 48.

[0117] The proximalmost row of cells 18 is arranged at the proximal end 12 and comprises a plurality of cells. The plurality of cells is arranged adjacent to each other and circumferentially around the lumen 16. Each cell of the proximalmost row of cells 18 can be equally sized and is formed by two proximal struts 24. Each proximal strut 24 comprises a first end 26 and a second end 28. The first ends 26 are connected to one another forming a proximalmost vertex 30. The second ends 28 are connected to a proximal vertex 40, such that every second proximal vertex 40 is unconnected with and free from a connection with a second end 28.

[0118] The proximalmost row of cells 18 can be flared outwardly with respect to the lumen 16 of the heart valve prosthesis 10, wherein the first ends 26 can be flared outwardly steeper than the second ends 28. In other preferred embodiments, the proximalmost row of cells 18 can be flared outwardly uniformly or the second ends 28 can be flared outwardly steeper than the first ends 26.

[0119] The distalmost row of cells 20 is arranged at the distal end 14 and comprises a plurality of cells. The plurality of cells is arranged adjacent to each other and circumferentially around the lumen 16. Each cell of the distalmost row of cells 20 can be equally sized and is formed by two distal struts 32. Each distal strut 32 comprises a first end 34 and a second end 36. The first ends 34 are connected to one another forming a distalmost vertex 38. The second ends 36 are connected to a distal vertex 42, such that every second distal vertex 42 is unconnected with and free from a connection with a second end 36.

[0120] The distalmost row of cells 22 can be flared outwardly with respect to the lumen 16 of the heart valve prosthesis 10, wherein the first ends 34 can be flared outwardly steeper than the second ends 36. In other preferred embodiments, the distalmost row of cells 22 can be flared outwardly uniformly or the second ends 36 can be flared outwardly steeper than the first ends 34.

[0121] In a preferred embodiment, the stent frame 48 can be balloon-expandable. In this embodiment, the stent frame 48 can be made from high-performance alloys, preferably MP35N. In other preferred embodiments, the stent frame 48 can be at least partially self-expanding and / or at least partially plastically deformable. In embodiments, in which the stent frame 48 is at least partially self-expandable, the stent frame 48 can be made at least partially from a shape-memory material, preferably from Nitinol.

[0122] The valve element 49 is attached to the stent frame 48 within the lumen 16. The valve element 49 can be any valve element that is attached to the stent frame 48 within the lumen 16 at least intermediary. A multitude of valve elements applicable will be known to the skilled person from prior art.

[0123] In preferred embodiments, the valve element 49 can comprise from 1 to 4 leaflets, i.e., 1, 2, 3, or 4 leaflets.Heart valve prosthesis according to the second aspect

[0124] Fig. 2 shows a heart valve prosthesis 100 according to a second aspect of the invention, also in a side-view.

[0125] The heart valve prosthesis 100 comprises a proximal end 12, a distal end 14, a central longitudinal axis 62, a stent frame 48, a valve element 49, and a deflecting element 50 and includes a lumen 16.

[0126] The heart valve prosthesis 100 is expandable between a radially crimped configuration and a radially expanded configuration. Fig. 1 shows the radially expanded configuration.

[0127] The proximal end 12 forms a first opening allowing a liquid to pass. When in use, the first opening allows blood to pass.

[0128] The distal end 14 forms a second opening allowing a liquid to pass. When in use, the second opening allows blood to pass.

[0129] The lumen 16 comprises a luminal side 58 and an abluminal side 60 and extends tubularly through the stent frame 48 such that a liquid can enter the lumen 16 via the proximal end 12, pass the lumen 16, and exit the lumen 16 via the distal end 14.

[0130] The lumen 16 extends tubularly through the heart valve prosthesis 10 such that a liquid can enter the lumen 16 via the proximal end 12, pass the lumen 16, and exit the lumen 16 via the distal end 14.

[0131] The luminal side 58 faces from the stent frame 48 towards the lumen 16. The luminal side 58 can be at least partially covered by a prosthetic material.

[0132] The abluminal side 60 faces from the stent frame 48 away from the lumen 16. The abluminal side 60 can be at least partially covered by a prosthetic material.

[0133] The central longitudinal axis 62 is defined perpendicularly through the lumen 16.

[0134] The stent frame 48 is formed from a plurality of adjacent cells. The plurality of adjacent cells is arranged in circumferential rows.

[0135] As will be clear to the skilled person, at least some of the cells can be sealed, for example by a prosthetic material.

[0136] The plurality of adjacent cells comprises a proximalmost row of cells 18, a distalmost row of cells 20, and at least one intermediate row of cells 22.

[0137] The at least one intermediate row of cells 22 is arranged in between the proximalmost row of cells 18 and the distalmost row of cells 20.

[0138] In a preferred embodiment, 3 intermediate rows of cells 22 are provided. In other preferred embodiments, from 1 to 5 intermediate rows of cells 22 can be provided.

[0139] In a preferred embodiment, each cell of the at least one intermediate row of cells 22 can have substantially the shape of a rhombus with a proximal vertex 40, a distal vertex 42, a right vertex 44, and a left vertex 46. The proximal vertex 40 and the distal vertex 42 can be opposite to one another in the longitudinal direction of the stent frame 48. The right vertex 44 and the left vertex 46 can be opposite to one another in the circumferential direction of the stent frame 48. A right vertex 44 of a first cell can be connected to a left vertex 46 of second cell adjacent to the first cell in the circumferential direction of the stent frame 48.

[0140] In a preferred embodiment, the proximalmost row of cells 18 can be arranged at the proximal end 12 and can comprise a plurality of cells. The plurality of cells can be arranged adjacent to each other and circumferentially around the lumen 16. Each cell of the proximalmost row of cells 18 can be equally sized and can be formed by two proximal struts 24. Each proximal strut 24 can comprise a first end 26 and a second end 28. The first ends 26 can be connected to one another forming a proximalmost vertex 30. The second ends 28 can be connected to a proximal vertex 40, such that every second proximal vertex 40 is unconnected with and free from a connection with a second end 28.

[0141] In a preferred embodiment, the proximalmost row of cells 18 can be flared outwardly with respect to the lumen 16 of the heart valve prosthesis, wherein the first ends 26 can be flared outwardly steeper than the second ends 28. In other preferred embodiments, the proximalmost row of cells 18 can be flared outwardly uniformly or the second ends 28 can be flared outwardly steeper than the first ends 26.

[0142] In a preferred embodiment, the distalmost row of cells 20 can be arranged at the distal end 14 and can comprise a plurality of cells. The plurality of cells can be arrangedadjacent to each other and circumferentially around the lumen 16. Each cell of the distal- most row of cells 20 can be equally sized and formed by two distal struts 32. Each distal strut 32 can comprise a first end 34 and a second end 36. The first ends 34 can be connected to one another forming a distalmost vertex 38. The second ends 36 can be connected to a distal vertex 42, such that every second distal vertex 42 is unconnected with and free from a connection with a second end 36.

[0143] In a preferred embodiment, the distalmost row of cells 22 can be flared outwardly with respect to the lumen 16 of the heart valve prosthesis, wherein the first ends 34 can be flared outwardly steeper than the second ends 36. In other preferred embodiments, the distalmost row of cells 22 can be flared outwardly uniformly or the second ends 36 can be flared outwardly steeper than the first ends 34.

[0144] In a preferred embodiment, the stent frame 48 can be balloon-expandable. In this embodiment, the stent frame 48 can be made from high-performance alloys, preferably MP35N.In other preferred embodiments, the stent frame 48 can be at least partially self-expanding and / or at least partially plastically deformable. In embodiments, in which the stent frame 48 is at least partially self-expandable, the stent frame 48 can be made at least partially from a shape-memory material, preferably from Nitinol.

[0145] The valve element 49 is attached to the stent frame within the lumen 16. The valve element 49 can be any valve element that is attached to the stent frame 48 within the lumen 16 at least intermediary. A multitude of valve elements applicable will be known to the skilled person from prior art.

[0146] In preferred embodiments, the valve element 49 can comprise from 1 to 4 leaflets, i.e. , 1, 2, 3, or 4 leaflets.

[0147] In other preferred embodiments, the stent frame 48 can be any stent frame that is provided with or connected to sufficient anchoring means anchoring the heart valve prosthesis 100 at its desired position within the respective heart valve. A multitude of stent frames 48 applicable will be known to the skilled person from prior art.

[0148] The deflecting element 50 is formed by a stent wire arm.

[0149] The stent wire arm comprises a first end 64, a first portion 74, an intermediate portion 66, a second portion 78, and a second end 68.

[0150] The stent wire arm is self-expandable from a crimped configuration into an expanded configuration and protrudes with the first portion 74, the intermediate portion 66, the second portion 78 and the second end 68 beyond the distal end 14 of the heart valve prosthesis 100. Fig. 2 shows the stent wire arm in an expanded configuration.

[0151] The first end 64 is connected to the stent frame 48 at a distal vertex 42, forming at least one attachment point 70. A single attachment point 70 can be provided. In such embodiment, the stent wire arm can be a single stent wire. The single attachment point 70 can be oblong.

[0152] In other preferred embodiments, more than one attachment point 70 can be provided. For example, the stent wire arm can be a stent wire forming a loop such that both ends of the stent wire forming a loop, i.e. the first end 64 and second end 68 are attached to the stent frame 48 forming at least one or two attachment points 70. The first end 64 is preferably attached to the stent frame 48 at a defined location on the stent frame, forming one attachment point70. The stent wire arm can also be a branched stent wire. Alternatively, the stent wire arm can be a framework or network of multiple stent wires attached to the stent frame 48, forming at least one attachment point 70.

[0153] In those and other preferred embodiments, the first end 64 can be connected to the ablu- minal side 60. In other preferred embodiments, the first end 64 can be connected to the stent frame 48 at the luminal side 58, abluminal side 60, distal end 14, or a combination of the aforementioned, preferably to the distal end 14 or at the distal end 14 and the abluminal side 58.

[0154] In preferred embodiments, the at least one attachment point 70 can be of any type. Preferably, the attachment point 70 is oblong, circular, ring-shaped, or polygonal, further preferably oblong, circular, or rectangular.

[0155] The attachment can be achieved, for example, by welding, gluing, crimping, or suturing. In other preferred embodiments, the attachment can be achieved by fabricating the stent frame 48 and the stent wire arm from one piece.

[0156] The first portion 74 is arranged distally from the distal end 14 and in between the first end 64 and the intermediate portion 66. The first portion 74 can extend from the first end 64 in the distal direction and can hold the intermediate portion 66 and the at least one attachment point 70 at a distance to each other. In a preferred embodiment, the distance is from 10 mm to 30 mm.

[0157] In a preferred embodiment, the first portion 74 is angled relative to and towards the distal end 14 in an angle p of 60°. In other preferred embodiments, the angle p can be from 30° to 85°, from about 30° and 60°, from about 35° to 55°C, from about 40° to 50°, and from 42° to 48°, with the outer ranges included, respectively. In a preferred embodiment, the angle is about 45°C.

[0158] The intermediate portion 66 is arranged distally from the distal end 14 and in between the first end 64 and the second end 68 and, at least in the expanded configuration, is curved with a preset radius. The preset radius can be 5 mm. In other preferred embodiments, the preset radius can be from 1 mm to 10 mm.

[0159] At least in the expanded configuration, a distance between the intermediate portion 66 and the central longitudinal axis 62 is smaller than a distance between the at least one attachment point 70 and the central longitudinal axis 62.

[0160] The second portion 78 is arranged distally from the distal end 14 and in between the intermediate portion 66 and the second end 68. The second portion 78 can extend from the intermediate portion 66 in the proximal direction and can be shorter than the first portion 74.In other preferred embodiments, the second portion 78 can be equally long as or longer than the first portion 74. Most preferably, the second portion 78 is approximately equally long as the first portion 74.

[0161] In a preferred embodiment, the second portion 78 is angled relative to the first portion 74 in an angle a of 190°. In other preferred embodiments, the angle a can be from 120° to 210°, preferably from 150° to 190°.

[0162] The second end 68 is unconnected to the stent frame 48 other than via the first end 64. In other words, the second end 68 is a free end. The second end 68 can be a straight end. In other preferred embodiments, the second end 68 can be rounded and / or bent and / or comprise a retainer configured to be grasped by and / or releasably connected to a pull-wire of a delivery catheter.

[0163] The retainer can be a circular stent wire, for example an eyelet, or a bent section of a stent wire.

[0164] At least in the expanded configuration, by virtue of the arrangement of the first portion 74, the intermediate portion 66 and the second portion 78, the deflecting element 50 is configured for accommodating a native leaflet. In preferred embodiments, the first portion 74, the intermediate portion 66 and the second portion 78 together form the deflecting element 50 to be 2D- or 3D- U-, V-, J-, or groove-shaped, preferably 2D- or 3D- U-, 2D-V-, 2D- or 3D-J-, or 3D-groove-shaped

[0165] Fig. 3 shows the heart valve prosthesis 100 implanted into the heart of a patient.

[0166] In this embodiment, the heart valve prosthesis 100 can be implanted into a human mitral valve comprising a degenerated surgical annuloplasty ring 80. The deflecting element 50 can accommodate the anterior mitral leaflet 82.

[0167] In other preferred embodiments, the heart valve 100 is for implantation into or use in the treatment of a heart valve comprising a degenerated surgical annuloplasty ring or adiseased native heart valve. Further preferably, the diseased native heart valve is an annular calcified heart valve, more preferably an annular calcified atrioventricular heart valve, and most preferably an annular calcified mitral valve.

[0168] In other preferred embodiments, the heart valve 100 can be for implantation into or use in the treatment of any diseased heart valve, wherein the disease is preferably a mitral valve insufficiency causing a regurgitation, and the heart valve is preferably a human heart valve, further preferably a human atrioventricular heart valve, most preferably a human mitral valve.

[0169] In preferred embodiments, in which the proximalmost row of cells 18 and the distalmost row of cells 20 are outwardly flared, the heart valve prosthesis 100 can be implanted such that the degenerated annuloplasty ring 80 or the calcified annulus, respectively, is positioned in between the outwardly flared proximalmost row of cells 18 and the outwardly flared distalmost row of cells 20 and circumferentially around the at least one intermediate row of cells 22.Delivery system for a heart valve prosthesis according to the second aspect

[0170] Fig. 4 shows a delivery system 200 for transseptal introduction of a heart valve 100 into the heart of a patient.

[0171] The delivery system 200 comprises a heart valve prosthesis 100, and a delivery catheter 84 and has a loaded state, a first deployment state, and a second deployment state.

[0172] The delivery catheter 84 comprises a retractable outer sheath 86.

[0173] The delivery catheter 84 can be loaded with the heart valve prosthesis 100. Various techniques for loading a delivery catheter with a heart valve prosthesis are known to the skilled person from the prior art.

[0174] The outer sheath 86 can be retractable in the proximal direction of the heart valve prosthesis 100.

[0175] Fig. 4A shows a delivery system 200 in the loaded state.

[0176] In the loaded state, the heart valve prosthesis 100 is loaded onto the delivery catheter 84 in a radially crimped configuration, included by the outer sheath 86, and the deflecting element 50 is in a crimped configuration, wherein the first portion 74 and the second portion 78 are not angled relative to each other and the intermediate portion 66 is not curved with the preset radius but unfolded or outstretched. The outer sheath 86 can hold the deflecting element 50 in the crimped configuration.

[0177] In other preferred embodiments, the deflecting element 50 can be hold in the crimped configuration by any means.

[0178] Fig. 4B shows a delivery system 200 in the first deployment state.

[0179] In the first deployment state, the outer sheath 86 can be completely retracted from the heart valve prosthesis 100, and the deflecting element 50 is in a folded configuration, wherein the intermediate portion 66 is curved with the preset radius.

[0180] In other preferred embodiments, in the first deployment state, the outer sheath 86 is at least partially retracted from the heart valve prosthesis 100. For example, the outer sheath 86 can partially or completely include the stent frame 48.

[0181] Fig. 4C shows a delivery system 200 in the second deployment state.

[0182] In the second deployment state, the outer sheath 86 is retracted from the heart valve prosthesis 100, the stent frame 48 can be expanded into the radially expanded configuration, and the deflecting element 50 is in the expanded configuration, wherein the deflecting element is deflected.

[0183] In other preferred embodiments, the heart valve prosthesis 100 is at least partially expanded into the radially expanded configuration. For example, the stent frame 48 may not have reached yet its final radial extension.

[0184] Fig. 5 shows a delivery system 300 for transapical introduction of a heart valve 100 into the heart of a patient.

[0185] The delivery system 300 comprises a heart valve prosthesis 100, a delivery catheter 84, and a pull-wire 88 and has a loaded state, a first deployment state, and a second deployment state.

[0186] The delivery catheter 84 comprises a retractable outer sheath 86.

[0187] The delivery catheter 84 can be loaded with the heart valve prosthesis 100. Various techniques for loading a delivery catheter with a heart valve prosthesis are known to the skilled person from the prior art.

[0188] The outer sheath 86 can be retractable in the distal direction of the heart valve prosthesis 100.

[0189] The pull-wire 88 is releasably connectable to the second end 68 and has a tense state and a relaxed state.

[0190] Fig. 6 shows a pull-wire 88 of a delivery system 300 in more detail.

[0191] The pull-wire 88 can comprise a sheath 90 and a wire 92.

[0192] The sheath 90 can enclose the wire 92 partially and can extend within the outer sheath 86.

[0193] The wire 92 can comprise a first end and a second end.

[0194] The first end of the wire 92 is connected to the delivery catheter 84 and can be retracted or rolled up as to exert a tensile force into the distal direction to the wire 92, respectively.

[0195] The second end of the wire 92 can be releasably attached to the second end 68 or to the delivery catheter 84 as to exert the tensile force exerted via the first end to the wire 92 further to the stent wire arm.

[0196] The releasable attachment to the second end 68 can be achieved for example by guiding the wire 92 with the second end of the wire 92 through or around a retainer and attaching it releasably at the delivery catheter 84, or by providing the second end of the wire 92 with a hook, barb, or other gripping means suitable for attaching it releasably at the second end 68.

[0197] Fig. 6A shows the pull-wire 88 in the tense state. The pull-wire 88 is releasably connected to the second end 68, exerts a tensile force onto the stent wire arm, and holds the deflecting element 50 in the crimped configuration.

[0198] Fig. 6B and 5B show the pull-wire 88 in the relaxed state. In the embodiment of Fig. 6B, the outer sheath 86 is retracted, and the pull-wire 88 is releasably attached to the second end 68 and holds the deflecting element 50 in a configuration, wherein the intermediate portion 66 is curved. In the embodiment of Fig. 6C and 5B, the outer sheath 86 (not shown in Fig. 6C) is retracted, the pull-wire 88 is not attached to the second end 68, and the intermediate portion 66 is curved with the preset radius.

[0199] Fig. 5A shows a delivery system 300 in a loaded state.

[0200] In the loaded state, the heart valve prosthesis 100 is loaded onto the delivery catheter 84 in a radially crimped configuration, included by the outer sheath 86, and the deflecting element 50 is in a crimped configuration, wherein the first portion 74 and the second portion 78 are not angled relative to each other and the intermediate portion 66 is not curved with the preset radius or unfolded or outstretched. The pull-wire 88 is in the tense state and can hold the deflecting element 50 in the crimped configuration.

[0201] In other preferred embodiments, the deflecting element 50 can be held in the crimped configuration by any means.

[0202] Fig. 5B shows a delivery system 300 in the first deployment state.

[0203] In the first deployment state, the outer sheath 86 can be completely retracted from the heart valve prosthesis 100, and the deflecting element 50 is in the folded configuration, wherein the intermediate portion 66 is curved with the preset radius.

[0204] In other preferred embodiments, in the first deployment state, the outer sheath 86 is at least partially retracted from the heart valve prosthesis 100.

[0205] Fig. 5C shows a delivery system 300 in the second deployment state.

[0206] In the second deployment state, the outer sheath 86 is retracted from the heart valve prosthesis 100, the heart valve prosthesis 100 can be expanded into the radially expanded configuration, and the deflecting element 50 is in the expanded configuration.

[0207] In other preferred embodiments, the heart valve prosthesis 100 is at least partially expanded into the radially expanded configuration. For example, the stent frame 48 may not have reached yet its final radial extension.Method for releasing a heart valve prosthesis according to the second aspect from a delivery system for introduction of a heart valve prosthesis according to the second aspect

[0208] A method 400 for releasing the heart valve prosthesis 100 from a delivery catheter is exemplified by Fig. 4. The method 400 comprises the steps a), b), c), and d).

[0209] The delivery catheter 84 the heart valve prosthesis 100 is to be released from can be the delivery catheter 84 of the delivery system 200. In other preferred embodiments of the method 400, the delivery catheter can be any delivery catheter, onto which the heart valve prosthesis 100 is loaded such that the heart valve prosthesis 100 is in a radially crimpedconfiguration and the deflecting element 50 is in a crimped configuration, the delivery catheter comprising a retractable outer sheath.

[0210] In the step a), the outer sheath 86 is retracted at least partially such that the second end 68 of the stent wire arm is exposed. The outer sheath 86 can be retracted in the proximal direction. In other preferred embodiments, the outer sheath 86 can be retracted in the distal direction.

[0211] In the step b), the second portion 78 is folded outwardly, i.e., to the abluminal side 60, until a preset radius of the intermediate portion 66 is reached and the deflecting element 50 is formed. The step b) can be conducted after completion of the step a) or before completion of the step a), i.e., at least partially simultaneously with the step a).

[0212] In embodiments, wherein the heart valve prosthesis 100 is to be released from is the delivery catheter 84 of delivery system 200, the second portion 78 can start to fold preferably with at least partial retraction of the outer sheath 86, i.e., the step b) can be conducted before completion of the step a).

[0213] In the step c), the stent wire arm is fully exposed, i.e., the outer sheath 86 is completely retracted from the stent wire arm. As will be clear to the skilled person, before expansion of the heart valve prosthesis 100, the outer sheath 86 is to be retracted completely from the stent frame 48. Various techniques for expanding a stent frame during release from a delivery catheter are known to the skilled person.

[0214] In the step d), the deflecting element 50 is to be deflected towards the central longitudinal axis 62, such that a distance between the intermediate portion 66 and the central longitudinal axis 62 is smaller than a distance between the attachment point 70 and the central longitudinal axis 62. The step d) can be conducted after completion of the step c) or before completion of the step c), i.e., at least partially simultaneously with the step c).

[0215] In embodiments, wherein the delivery catheter the heart valve prosthesis 100 is to be released from is the delivery catheter 84 of delivery system 200, the deflecting element 50can start to deflect preferably with at least partial expansion of the stent frame 48, i.e., the step d) can be conducted before completion of the step c).

[0216] A method 500 for releasing the heart valve prosthesis 100 from a delivery catheter is exemplified by Fig. 5 and 6. The method 500 comprises the steps a), aa), b), bb), c), and d).

[0217] The delivery catheter the heart valve prosthesis 100 is to be released from can be the delivery catheter 84 of the delivery system 300. In other preferred embodiments of the method, the delivery catheter can be any delivery catheter, onto which the heart valve prosthesis 100 is loaded such that the heart valve prosthesis 100 is in a radially crimped configuration and the deflecting element 50 is in a crimped configuration, the delivery catheter comprising a retractable outer sheath and a pull-wire releasably connected to the second end 68 and exerting a tensile force to the stent wire arm at least when the outer sheath is retracted.

[0218] In the step a), the outer sheath 86 can be retracted completely such that the second end 68 of the stent wire arm is exposed. The outer sheath 86 can be retracted in the distal direction. In other preferred embodiments, the outer sheath can be retracted in the proximal direction.

[0219] In the step aa), the tensile force exerted by the pull-wire 88 onto the stent wire arm can be reduced, i.e., the pull-wire is transferred from the tense state into the relaxed state.

[0220] In the step b), the second portion 78 is folded outwardly, i.e., to the abluminal side 60, until a preset radius of the intermediate portion 66 is reached and the deflecting element 50 is formed. The step b) can be conducted after completion of the step aa) or before completion of the step aa), i.e., at least partially simultaneously with the step aa).

[0221] In embodiments, wherein a delivery catheter the heart valve prosthesis 100 is to be released from is the delivery catheter 84 of delivery system 300, the second portion 78 can start to fold preferably with reduction of the tensile force exerted by the pull-wire 88, i.e., the step b) can be conducted before completion of the step aa).

[0222] In the step bb), the second end 68 can be detached from the pull-wire 88. This can be conducted by detaching the first end of the wire 92 from the delivery catheter 84. In embodiments, wherein the first end of the wire 92 is releasably attached to the second end 68, this can be achieved by detaching the first end of the pull-wire 88 from the second end 68.

[0223] In the step c), the stent wire arm is fully exposed, i.e., the outer sheath 86 is completely retracted from the stent wire arm. As will be clear to the skilled person, before expansion of the heart valve prosthesis 100, the outer sheath 86 is to be retracted completely from the stent frame 48. Various techniques for expanding a stent frame during release from a delivery catheter are known to the skilled person.

[0224] In the step d), the deflecting element 50 is to be deflected towards the central longitudinal axis 62, such that a distance between the intermediate portion 66 and the central longitudinal axis 62 is smaller than a distance between the attachment point 70 and the central longitudinal axis 62. The step d) can be conducted after completion of the step c) or before completion of the step c), i.e., at least partially simultaneously with the step c).

[0225] In embodiments, wherein the delivery catheter the heart valve prosthesis 100 is to be released from is the delivery catheter 84 of delivery system 300, the deflecting element 50 can start to deflect preferably with at least partial expansion of the stent frame 48, i.e., the step d) can be conducted before completion of the step c).

Claims

Claims1. A heart valve prosthesis (100) for implantation into the heart of a patient, wherein the heart valve prosthesis (100) is expandable between a radially crimped configuration and a radially expanded configuration, and includes a lumen (16), having a luminal side (58) and an abluminal side (60), a distal end (14) and a proximal end (12), and a central longitudinal axis (62) defined perpendicularly through the lumen (16), and comprising a stent frame (48) and a valve element (49) being attached to the stent frame (48) within the lumen (16), wherein the stent frame (48) is formed from a plurality of adjacent cells arranged in circumferential rows, wherein the plurality of cells comprises a proximal- most row of cells (18) at the proximal end (12) and a distalmost row of cells (20) at the distal end (14), and at least one intermediate row of cells (22), arranged between the proximalmost row of cells (18) and distalmost row of cells (20), and wherein the heart valve prosthesis (100) further comprises a deflecting element (50) for keeping a native leaflet from obstructing ventricular outflow, wherein the deflecting element (50) is formed by a stent wire arm, which is self-expandable and can be expanded from a crimped configuration into an expanded configuration, and which comprises a first end (64), a first portion (74), an intermediate portion (66), a second portion (78), and a second end (68), which stent wire arm, via its first end (64), is attached to the stent frame (48), forming at least one attachment point (70), and protrudes with the first portion (74), the intermediate portion (66), the second portion (78), and the second end (68) beyond the distal end (14) of the heart valve prosthesis (100), with the second end (68) being unattached to the stent frame (48), and wherein- the first portion (74), the intermediate portion (66), and the second portion (78) are configured to form the deflecting element (50) for accommodating the native leaflet, and- wherein a distance between the intermediate portion (22) and the central longitudinal axis (62) of the heart valve prosthesis (100) is smaller than a distance between the at least one first end’s attachment point (70) and the central longitudinal axis (62) of the heart valve prosthesis (100).

2. The heart valve prosthesis (100) of claim 1 , wherein the deflecting element (50) is formed such, that the intermediate portion (22) is curved with a preset radius, effecting that the first portion (74) generally expands into the distal direction or away from the distal end (14), and the second portion (78) generally expands into the proximal direction or towards the distal end (14).

3. The heart valve prosthesis (100) of claim 1 or 2, wherein the deflecting element (50), with respect to the central longitudinal axis (62), is angled relative to and towards the distal end (14) in an angle [3 of between 30° and 85°.

4. The heart valve prosthesis (100) of any of claims 1 to 3, wherein the first portion (74) and second portion (78) are angled in an angle a of between 120° to 210°.

5. The heart valve prosthesis (100) of any of claims 1 to 4, wherein the first end (64) of the stent wire arm is attached to the abluminal side (60) or luminal side (58), or to a distalmost point of the distalmost row of cells (20), or a combination of the aforementioned.

6. The heart valve prosthesis (100) of any of claims 1 to 5, wherein each cell of the at least one intermediate row of cells (22) has substantially the shape of a rhombus with a proximal vertex (40) and an distal vertex (42), being opposite to one another in the longitudinal direction of the stent frame (48), and with a right vertex (44) and a left vertex (46), being opposite to one another in the circumferential direction of the stent frame (48), wherein a right vertex (44) of a first cell in the at least one intermediate row of cells (22) is connected to a left vertex (46) of second cell adjacent to the first cell of the intermediate row of cells (22) in the circumferential direction, and whereineach cell of the proximalmost row of cells (18) is formed by two proximal struts (24) each having a first end (26) and a second end (28), the first ends (26) of the two proximal struts (24) being connected to one another forming an proximal- most vertex (30), and each end of the second ends (28) of the two proximal struts (24) being connected to a proximal vertex (40) of a cell of the intermediate row of cells (22) lying adjacent to the proximalmost row of cells (18), such, that one proximal vertex (40) of a cell of the intermediate row of cells (22) that lies adjacent to the proximalmost row of cells (18) is unconnected with and free from a connection with the second ends (28), and wherein each cell of the distalmost row of cells (20) is formed by two distal struts (32) each having a first end (34) and a second end (36), the first ends (34) of the two distal struts (32) being connected to one another forming an distalmost vertex (38), and each end of the second ends (36) of the two distal struts (32) being connected to a distal vertex (42) of a cell of the intermediate row of cells (22) lying adjacent to the distalmost row of cells (20), such, that one distal vertex (42) of a cell of the intermediate row of cells (22) that lies adjacent to the distalmost row of cells (20) is unconnected with and free from a connection with the second ends (36).

7. The heart valve prosthesis (100) of any of claims 1 to 6, wherein the proximalmost row of cells (18) and the distalmost row of cells (20) are outwardly flared, respectively, with respect to the lumen (16) of the heart valve prosthesis (100).

8. The heart valve prosthesis of any of claims 1 to 7, comprising between 1 and 5 intermediate row(s) of cells (22).

9. A heart valve prosthesis (10) for implantation into the heart of a patient, wherein the heart valve prosthesis (10) is expandable between a radially crimped configuration and a radially expanded configuration, and includes a lumen (16), having a luminal side (58) and an abluminal side (60), a distal end (14) and a proximal end (12), and a central longitudinal axis (62) defined perpendicularly through the lumen (16), and comprising a stent frame (48) and a valve element (49) being attached to the stent frame (48) within the lumen (16), whereinthe stent frame (48) is formed from a plurality of adjacent cells arranged in circumferential rows, wherein the plurality of cells comprises a proximalmost row of cells (18) at the proximal end (12) and a distalmost row of cells (20) at the distal end (14), and at least one intermediate row of cells (22), arranged between the proximalmost row of cells (18) and distalmost row of cells (20), wherein each cell of the at least one intermediate row of cells (22) has substantially the shape of a rhombus with a proximal vertex (40) and an distal vertex (42), being opposite to one another in the longitudinal direction of the stent frame (48), and with a right vertex (44) and a left vertex (46), being opposite to one another in the circumferential direction of the stent frame (48), wherein a right vertex (44) of a first cell in the at least one intermediate row of cells (22) is connected to a left vertex (46) of second cell adjacent to the first cell of the intermediate row of cells (22) in the circumferential direction, and wherein each cell of the proximalmost row of cells (18) is formed by two proximal struts (24) each having a first end (26) and a second end (28), the first ends (26) of the two proximal struts (24) being connected to one another forming a proximalmost vertex 30, and each end of the second ends (28) of the two proximal struts being connected to a proximal vertex (40) of a cell of the intermediate row of cells (22) lying adjacent to the proximalmost row of cells (18), such, that one proximal vertex (40) of a cell of the intermediate row of cells (22) that lies adjacent to the proximalmost row of cells (18) is unconnected with and free from a connection with the second ends (28), and wherein each cell of the distalmost row of cells (20) is formed by two distal struts (32) each having a first end (34) and a second end (36), the first ends (34) of the two distal struts (32) being connected to one another forming an distalmost vertex (38), and each end of the second ends (36) of the two distal struts (34) being connected to a distal vertex (42) of a cell of the intermediate row of cells (22) lying adjacent to the distalmost row of cells (20), such, that one distal vertex (42) of a cell of the intermediate row of cells (22) that lies adjacent to the distalmost row of cells (20) is unconnected with and free from a connection with the second ends (36).

10. The heart valve prosthesis (10) of claim 9, wherein the proximalmost row of cells (18) and the distalmost row of cells (20) are outwardly flared, respectively, with respect to the lumen (16) of the heart valve prosthesis (10).

11. The heart valve prosthesis (10) of claim 9 or 10, comprising between 1 and 5 intermediate row(s) of cells (22).

12. The heart valve prosthesis (100) of any of the proceeding claims, wherein the valve element (49) comprises between 1 and 4 leaflets.

13. The heart valve prosthesis (100) of any one of the preceding claims, wherein the stent frame (48) is at least partially self-expanding and / or at least partially plastically deformable, preferably plastically deformable via inflation of a balloon.

14. The heart valve prosthesis (100) of any of the preceding claims, being a mitral valve prosthesis.

15. The heart valve prosthesis (100) of any one of the preceding claims for implantation into or use in the treatment of a heart valve having a degenerated surgical an- nuloplasty ring (80) or a diseased native heart valve, wherein the diseased native valve is preferably an annular calcified heart valve, most preferably an annular calcified mitral heart valve.

16. A delivery system (200; 300) for introducing a heart valve prosthesis (100) into the heart of a patient, wherein the delivery system (200; 300) comprises a heart valve prosthesis (100) according to any of the preceding claims, a delivery catheter 84, the delivery catheter (84) comprising a retractable outer sheath (86) that, in a state where the heart valve prosthesis (100) is loaded onto the delivery catheter (84), holds the heart valve prosthesis in a crimped state, wherein the delivery system (200; 300) is configured, such, that in the loaded state and crimped state of the heart valve prosthesis (100), the first portion (74) and the second portion (78) of the stent wire arm arenot angled relative to each other, and the intermediate portion (22) is not curved; and wherein upon retraction of the outer sheath (86), first the second end (68) of the stent wire arm is exposed, then the second portion (78) is folded outwardly until a preset radius of the intermediate portion (66) is reached and the deflecting element (50) is formed, and, when the second portion (78) is folded outwardly, and after full exposure of the stent wire arm, the deflecting element (50) deflects towards the central longitudinal axis (62), such, that a distance between the intermediate portion (22) and the central longitudinal axis (62) of the heart valve prosthesis (100) is smaller than a distance between the first end’s (64) attachment point (70) and the central longitudinal axis (62) of the heart valve prosthesis (100), preferably wherein the deflecting element (50) is angled relative to and towards the distal end (14) in an angle p of between 30° and 85°.

17. The delivery system (200) of claim 16, wherein the outer sheath (86) is retracted in the proximal direction.

18. The delivery system (300) of claim 16 or 17, wherein the delivery catheter (84) further comprises a pull-wire (88), wherein the pull wire (88), in the state where the heart valve prosthesis (100) is loaded onto the delivery catheter (84), is releasably attached to the second end (68) and exerts a tensile force onto the stent wire arm, and the outer sheath (86) is retracted in the distal direction, and the second portion (78) is folded outwardly upon reduction of the tensile force exerted by the pull-wire (88), and after the second portion (78) was folded outwardly, the second end (68) is detached from the pull-wire.

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