heart valve prosthesis

Abstract

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

Description

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

[0002] The present invention relates to the field of heart valve replacement or heart valve support, in particular the replacement or support of a heart valve that has a degenerated annuloplasty ring or ring calcification, in particular for implantation into a mitral valve that has a degenerated annuloplasty ring or mitral valve ring calcification. BACKGROUND

[0003] Native heart valves are one-way valves, meaning they allow blood to pass through in the direction of normal blood flow but not backward. Many diseases or risk factors, such as age and sex, are known to be associated with heart valve dysfunction. Such dysfunction is usually associated with regurgitation, the backflow of blood through the heart valve in a non-normal direction. Particularly if prolonged, regurgitation can worsen and become life-threatening.

[0004] Furthermore, a malfunctioning heart valve can cause malfunctions in other heart valves. In particular, mitral valve dysfunction can lead to aortic valve closure, as a mitral valve leaflet is forced into an unfavorable position within the ventricle. This is known to occur especially during transcatheter mitral valve replacement (TMVR).

[0005] In recent years, techniques for implanting heart valve prostheses of various shapes have been developed, with the aim of replacing or supporting the native heart valve. With most of these techniques and the corresponding heart valve prostheses, it is common practice to achieve sufficient anchoring of the prosthesis while allowing the surrounding heart tissue to continue functioning, i.e., to adapt to the dynamic movement of the heart during the cardiac cycle.

[0006] In particular, anchoring the heart valve prosthesis to the ventricular side of the natural heart valve can be challenging, as most anchoring techniques rely on the expansion of an anchoring structure against the natural annulus and leaflets, which can cause the annulus to expand and / or, depending on the patient's anatomy, force a leaflet to expand into the right ventricular outflow tract or the left ventricular outflow tract.

[0007] US 11,633,278 B2 discloses a mitral valve prosthesis featuring a stent frame with an outwardly flared distal, middle, and proximal cell row, wherein every second distal vertex of a cell row in the middle row adjacent to the proximal row is not connected to the proximal row. This allows the proximal row to be large, improving anchorage. Conversely, the distal row is smaller than the proximal row to avoid obstruction of the left ventricular outflow tract. Therefore, barbs are provided on the distal cell row to further improve anchorage. However, such barbs can damage surrounding tissue, and the small size of the distal row increases the risk of prosthesis displacement, for example, in the case of progressive annular dilatation.

[0008] EP 3 760 165 A1 discloses a mitral valve prosthesis comprising a stent frame with an outwardly expanded distal, a middle, and a proximal cell row. To avoid obstruction of the left ventricular outflow tract, the stent frame is asymmetrically designed such that no cells, or cells smaller than the other cells of the distal row, are provided on the side adjacent to the left ventricular outflow tract. However, the omission or minimization of cells in the distal row destabilizes the anchoring and thus increases the risk of displacement.

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

[0010] Therefore, an objective of the present invention is to provide a heart valve prosthesis that enables adequate anchoring, a minimal risk of tissue injury or obstruction of a ventricular outflow tract, and the correction of an adverse anatomy in this respect. SUMMARY OF THE INVENTION

[0011] In a first aspect, the goal is achieved by a heart valve prosthesis for implantation into a patient's heart, wherein the heart valve prosthesis is expandable between a radially crimped or compressed configuration and a radially expanded configuration and has 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 which has a stent frame and a valve element 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 has a most proximal cell row at the proximal end and a most distal cell row at the distal end, and at least one intermediate cell row arranged between the most proximal cell row and the most distal cell row, wherein Each cell of the at least one middle cell row has essentially the shape of a rhombus with a proximal apex and a distal apex opposite each other in the longitudinal direction of the stent frame, and with a right apex and a left apex opposite each other in the circumferential direction of the stent frame, wherein a right apex of a first cell in the at least one middle cell row is connected to a left apex of a second cell that borders the first cell of the middle cell row in the circumferential direction, and wherein Each cell of the most proximal cell row is formed by two struts, each with a first end and a second end, wherein the first ends of the two struts are connected to each other and form a most proximal vertex, and each end of the second ends of the two struts is connected to a proximal vertex of a cell of the middle cell row adjacent to the most proximal cell row, wherein a proximal vertex(s) of a cell of the middle cell row adjacent to the most proximal cell row is not connected to the second ends and is free from any connection with them, and wherein Each cell of the most distal cell row is formed by two struts, each with a first end and a second end, the first ends of the two struts being connected to each other and forming a most distal vertex, and each end of the second ends of the two struts being connected to a distal vertex of a cell of the middle cell row adjacent to the most distal cell row, such that one distal vertex(s) of a cell of the middle cell row adjacent to the most distal cell row is not connected to the second ends and is free from any connection to the second ends.

[0012] The term “stent frame” here, as is generally the case in this field, refers to a net or grid / frame made of stent wires that forms a generally tubular frame to provide a degree of rigidity and flexibility to and support the optional prosthetic material that at least partially covers the stent frame.

[0013] Accordingly, the term “cells” in the present description, as is generally the case in this field, is to be understood as a through-hole within the stent frame, i.e., as the meshes of the net or grid that forms the stent frame, including the stent wires that form the respective mesh.

[0014] In the present description, the direction “proximal” refers to a direction that points away from a heart chamber (ventricle), while the direction “distal” refers to a direction that points towards or into a heart chamber (ventricle).

[0015] The term "vertex" here is to be understood consistently as an extreme point. Such an extreme point can be formed by an acute or obtuse angle or by a curve; that is, a vertex can be acute or pointed, or smooth or only slightly curved.

[0016] The heart valve prosthesis can be expanded between a radially crimped or compressed configuration and a radially expanded configuration. As will be clear to those skilled in the art, a heart valve prosthesis can be implanted minimally invasively using a delivery catheter. Thus, a radially crimped configuration of a heart valve prosthesis is the configuration the prosthesis has when loaded onto such a delivery catheter. Conversely, a radially expanded configuration of a heart valve prosthesis is the configuration the prosthesis has when implanted into a patient's heart.

[0017] A distal vertex(s) of a cell in the middle cell row, each adjacent to the distalmost cell row or the proximalmost cell row respectively, which is / are not connected to the second end(s) and is / are free from any connection to the second end(s), is to be understood as meaning that the respective proximal or distal vertex is not connected to a second end or to a second end other than the middle one, i.e., for example, via a left or right vertex.

[0018] In a preferred embodiment, each end of the second ends of the two struts forming the most proximal cell row is connected to a proximal vertex of a cell of the middle cell row adjacent to the most proximal cell row, such that each second proximal vertex of a cell of the middle cell row adjacent to the most proximal cell row is not connected to the second ends and is free from any connection with the second ends.

[0019] This advantageously leads to greater malleability of the proximal cell row and less resistance during the expansion process.

[0020] In a preferred embodiment, each end of the second ends of the two struts forming the distalmost cell row is connected to a distal vertex of a cell of the middle cell row adjacent to the distalmost cell row, such that each second distal vertex(s) of a cell of the middle cell row adjacent to the distalmost cell row is not connected to the second ends and is free from any connection with the second ends.

[0021] This advantageously leads to greater malleability of the distal cell row and less resistance during the expansion process.

[0022] In a preferred embodiment, the most proximal cell row and the most distal cell row are each flared outwards in the direction of the lumen of the heart valve prosthesis.

[0023] This advantageously leads to sufficient anchoring of the heart valve prosthesis in the native annulus.

[0024] In a preferred embodiment, the heart valve prosthesis has between 1 and 5 intermediate cell rows.

[0025] This selection has the advantage of creating a sufficiently rigid stent frame that further supports the anchoring of the heart valve prosthesis by generating friction to withstand the forces to which the heart valve prosthesis is subjected during implantation, while at the same time ensuring sufficient flexibility for function.

[0026] In a preferred embodiment, the stent frame is at least partially self-expanding and / or at least partially plastically deformable.

[0027] The stent frame, which is at least partially self-expanding, advantageously facilitates implantation, as it does not need to be fully expanded by the surgeon.

[0028] The stent frame, which is at least partially plastically deformable, advantageously allows the heart valve prosthesis to be adapted to the individual anatomy of the patient during implantation.

[0029] The partially self-expanding and partially plastically deformable stent frame makes it possible to provide parts of the stent frame, which are known to need to be adapted to the individual anatomy of the patient, with a plastic deformability that is advantageous in this respect, while parts of the stent frame that do not require such adaptation can be provided with the easily manageable self-expandability.

[0030] In a preferred embodiment, the stent frame is plastically deformable by inflating a balloon, i.e., the stent frame is balloon-expandable.

[0031] In a preferred embodiment, the heart valve prosthesis is intended for implantation in or use in the treatment of a diseased natural heart valve.

[0032] In a preferred embodiment, in which the most proximal and distal cell rows are expanded outwards, the heart valve prosthesis is intended for implantation in or use in the treatment of a heart valve that has a degenerated surgical annuloplasty ring or a diseased native heart valve, wherein the diseased native valve is preferably a ring calcification of the heart valve, most preferably a ring calcification of the mitral valve. In such a case, the stent frame is advantageous because an annuloplasty ring, even if degenerated, or a ring calcification provides additional support for the most proximal and distal cell rows, both of which are expanded outwards.

[0033] In a preferred embodiment, the stent frame is manufactured from a single piece.

[0034] This advantageously increases the longevity and stability of the heart valve prosthesis.

[0035] In a second aspect, the problem is solved by a heart valve prosthesis for implantation into a patient's heart, wherein the heart valve prosthesis is expandable between a radially crimped configuration and a radially expanded configuration and has 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 which has a stent frame and a valve element 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 has a most proximal cell row at the proximal end and a most distal cell row at the distal end, and at least one intermediate cell row arranged between the most proximal cell row and the most distal cell row, and wherein the heart valve prosthesis further comprises - a deflection element to prevent a native valve from obstructing ventricular outflow, wherein the deflection element is formed by a stent wire arm that is self-expanding and can be expanded from a crimped configuration to an expanded configuration, and which has a first end, a first section, an intermediate section, a second section and a second end, - wherein the stent wire arm is attached to the stent frame via its first end, forming an attachment point, and extends beyond the distal end of the heart valve prosthesis with its first section, intermediate section, second section and second end, the second end not being attached to the stent frame, and wherein - the first section, the intermediate section and the second section are configured to form the deflection element for receiving the native valve, and - wherein the distance between the intermediate section and the central longitudinal axis of the heart valve prosthesis is less than the distance between the at least one attachment point of the first end and the central longitudinal axis of the heart valve prosthesis.

[0036] The heart valve prosthesis can be expanded between a radially crimped configuration and a radially expanded configuration. As will be clear to those skilled in the art, a heart valve prosthesis can be implanted minimally invasively using a delivery catheter. Thus, a radially crimped configuration of a heart valve prosthesis is the configuration the prosthesis has when loaded onto such a delivery catheter. Conversely, a radially expanded configuration of a heart valve prosthesis is the configuration the prosthesis has when implanted into a patient's heart.

[0037] According to the present invention, a "deflecting element" is an element shaped and designed to prevent a native valve from obstructing ventricular outflow, or to keep the valve in its position, i.e., to deflect it. According to the present invention, the deflecting element is formed by a stent wire arm. The stent wire arm can preferably 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 stent wire are connected to the stent frame, in which case the first end is preferably connected to the stent frame via two attachment points. The stent wire arm can also be a branched stent wire.Alternatively, the stent wire arm can be a framework or a network of several stent wires connected to the stent frame via at least one attachment point.

[0038] The stent wire arm extends beyond the distal end of the heart valve prosthesis with its first section, intermediate section, second section, and second end.

[0039] This advantageously reduces interference between the deflecting element and the valve element and minimizes or avoids the risk of transvalvular leakage.

[0040] The distance between the middle section and the central longitudinal axis is smaller than the distance between the attachment point and the central longitudinal axis, because in this way the native valve received by the deflection element is deflected by the deflection element into a position that allows efficient blood flow through the heart valve into which the heart valve prosthesis is implanted, as well as through another adjacent heart valve, whereas without the deflection element, the blood flow through this other heart valve would be impaired by an unfavorable position of the native valve.

[0041] As the expert will understand, the distance between the intermediate section and the central longitudinal axis and the distance between the attachment point and the central longitudinal axis depend on the individual anatomical requirements of the patient.

[0042] In a preferred embodiment, the deflecting element is designed such that the intermediate section is curved with a preset radius, causing the first section to generally extend in a distal direction or away from the distal end, and the second section to generally extend in a proximal direction or towards the distal end.

[0043] With such a configuration, the deflecting element can advantageously capture or encompass at least a portion of the free edge of the native valve, thereby allowing the valve's position to be influenced by the deflecting element, particularly by deflecting the deflecting element. Thus, the deflecting element is advantageously configured to securely receive the native valve.

[0044] In a preferred embodiment, the preset radius is 1 mm to 10 mm.

[0045] Such a radius advantageously allows the flap to be securely grasped or gently clamped, but not so tightly as to damage the flap tissue.

[0046] In a preferred embodiment, the deflecting element is angled relative to the distal end at an angle β between 30° and 85°, preferably 50° to 85°, including the outer regions. In a further preferred embodiment, the deflecting element is angled relative to and in the direction of the distal end at an angle β between approximately 30° and 60°, preferably approximately 35° to 55°, preferably approximately 40° to 50°, and even more preferably approximately 42° to 48°, including the outer regions. In a preferred embodiment, the angle is approximately 45°.

[0047] Such an angle β advantageously allows the native valve to be sufficiently deflected from an outflow channel of another heart valve without obstructing the heart valve prosthesis itself.

[0048] In a preferred embodiment, the first section and the second section are angled at an angle α between about 120° and 210°, about 140° and about 190°, and about 160° and about 180°.

[0049] Such an angle α advantageously allows the deflecting element to sufficiently accommodate the native flap in order to hold or clamp it securely.

[0050] In a preferred embodiment, the first end of the stent wire arm is attached to the abluminal side or the luminal side or to a most distal point of the most distal cell row or a combination of the aforementioned points.

[0051] This reduces the extension of the deflection element within or through the lumen or between the heart valve prosthesis and the surrounding tissue compared to attachment at the most proximal point of the most proximal cell row, which advantageously reduces interference of the deflection element with the valve element and the risk of paravalvular leakage.

[0052] In a preferred embodiment, the stent wire arm, preferably at least the intermediate section and / or the first end of the stent wire arm or the stent wire arm as such, is made at least partially or completely of a shape memory material, preferably nitinol. This advantageously ensures self-expandability and / or deflection of the deflection element.

[0053] In a preferred embodiment, the stent frame and the stent wire arm are manufactured from a single piece. This advantageously smooths the surface at the fixation site, thereby reducing the risk of injury to the surrounding tissue and improving the stability and longevity of the fixation.

[0054] In a preferred embodiment, each cell of the at least one middle cell row has essentially the shape of a rhombus with a proximal apex and a distal apex opposite each other in the longitudinal direction of the stent frame, and with a right apex and a left apex opposite each other in the circumferential direction of the stent frame, wherein a right apex of a first cell in the at least one middle cell row is connected to a left apex of a second cell which is circumferentially adjacent to the first cell of the middle cell row, and wherein Each cell of the most proximal cell row is formed by two struts, each with a first end and a second end, wherein the first ends of the two struts are connected to each other and form a most proximal vertex, and each end of the second ends of the two struts is connected to a proximal vertex of a cell of the middle cell row adjacent to the most proximal cell row, wherein a proximal vertex(s) of a cell of the middle cell row adjacent to the most proximal cell row is not connected to the second ends and is free from any connection with them, and wherein Each cell of the most distal cell row is formed by two struts, each with a first end and a second end, the first ends of the two struts being connected to each other and forming a proximal vertex, and each end of the second ends of the two struts being connected to a distal vertex of a cell of the middle cell row adjacent to the most distal cell row, such that a distal vertex(s) of a cell of the middle cell row adjacent to the most distal cell row is not connected to the second ends and is free from any connection with them.

[0055] A distal vertex(s) of a cell in the middle cell row adjacent to the most distal cell row or proximal cell row is / are to be understood as meaning that the respective proximal or distal vertex is not connected to a second end or to a second end other than the middle one, i.e., for example, via a left or right vertex.

[0056] This embodiment advantageously provides sufficient anchoring of the heart valve prosthesis, to which the anchoring of the deflection element does not contribute.

[0057] In a preferred embodiment, each end of the second ends of the two struts forming the most proximal cell row is connected to a proximal vertex of a cell of the middle cell row adjacent to the most proximal cell row, such that each second proximal vertex of a cell of the middle cell row adjacent to the most proximal cell row is not connected to the second ends and is free from any connection with the second ends.

[0058] This advantageously leads to a more uniform and improved flexibility of the cells in the proximal cell row. This improved flexibility enhances the adaptability of the stent frame to the individual anatomical needs of the patient.

[0059] In a preferred embodiment, each end of the second ends of the two struts forming the distalmost cell row is connected to a distal vertex of a cell of the middle cell row adjacent to the distalmost cell row, such that each second distal vertex(s) of a cell of the middle cell row adjacent to the distalmost cell row is not connected to the second ends and is free from any connection with the second ends.

[0060] This advantageously leads to a more uniform and improved flexibility of the cells in the distal cell layer. This improved flexibility enhances the adaptability of the stent frame to the individual anatomical needs of the patient. Preferably, the patient is a mammal, preferably a human.

[0061] In a preferred embodiment, the stent frame is manufactured from a single piece. This advantageously improves the durability and stability of the heart valve prosthesis.

[0062] In a preferred embodiment, the most proximal cell row and the most distal cell row are each widened outwards with respect to the lumen of the heart valve prosthesis.

[0063] This advantageously leads to sufficient anchoring of the heart valve prosthesis in the native annulus.

[0064] In a preferred embodiment, the heart valve prosthesis has between 1 and 5 intermediate cell rows.

[0065] Such a selection advantageously results in a sufficiently rigid stent frame to further maintain the anchoring of the heart valve prosthesis by generating friction to withstand forces to which the heart valve prosthesis is subjected during implantation, while at the same time ensuring sufficient flexibility for function.

[0066] In a preferred embodiment, the flap element has one to four sails.

[0067] In a preferred embodiment, the stent frame is at least partially self-expanding and / or at least partially plastically deformable.

[0068] The stent frame, which is at least partially self-expanding, advantageously facilitates implantation, as it does not need to be fully expanded by the surgeon.

[0069] The stent frame, which is at least partially plastically deformable, advantageously allows the heart valve prosthesis to be adapted to the individual anatomy of the patient during implantation.

[0070] The partially self-expanding and partially plastically deformable stent frame makes it possible to provide parts of the stent frame, which are known to need to be adapted to the individual anatomy of the patient, with a plastic deformability that is advantageous in this respect, while parts of the stent frame that do not require such adaptation can be provided with the easy-to-use self-expandability.

[0071] In a preferred embodiment, the heart valve prosthesis is plastically deformable by inflating a balloon, i.e., the heart valve prosthesis is balloon-expandable.

[0072] In a preferred embodiment, the first end of the stent wire arm is attached to a distal apex of a cell of the middle cell row adjacent to the most distal cell row, preferably to a distal apex to which at least a second end of a bridge forming the most distal cell row is connected.

[0073] Such a fixation is advantageous in that it prevents the deflecting element from extending unnecessarily into the lumen, which can lead to disturbance of the valve element or between the native valve tissue and the heart valve prosthesis, which in turn can cause paravalvular leakage.

[0074] In a preferred embodiment, the heart valve prosthesis is a mitral valve prosthesis.

[0075] This is advantageous because the aortic and mitral valves are located close to each other and are angled in such a way that the aortic valve can easily be at least partially closed by the anterior mitral valve. Thus, the heart valve prosthesis, by means of the deflection element, allows the anterior mitral valve to be deflected in such a way that the aortic valve does not become closed.

[0076] In a preferred embodiment, the heart valve prosthesis is intended for implantation in or use in the treatment of a diseased native heart valve.

[0077] In a preferred embodiment, the heart valve prosthesis is intended for implantation in or use in the treatment of an annularly calcified heart valve.

[0078] The heart valve prosthesis is advantageous for implantation in or use in the treatment of ring calcification of a heart valve, since ring calcification of the heart valve provides sufficient support for the heart valve prosthesis.

[0079] In a preferred embodiment, the heart valve prosthesis is intended for implantation in or use in the treatment of annular calcification of a mitral valve.

[0080] The heart valve prosthesis is advantageous for implantation in or use in the treatment of mitral valve annular calcification, since in mitral valve calcification it is known that the anterior valve of the natural mitral valve tends to be in a position that is unfavorable for catheter-based mitral valve replacement (TMVR), i.e., it obstructs efficient blood flow through the left ventricular outflow tract or the aortic valve after implantation of prior art heart valve prostheses.

[0081] In a preferred embodiment, the heart valve prosthesis is intended for implantation in or use in the treatment of a heart valve that has a degenerated surgical annuloplasty ring. In such a case, the stent frame is advantageous because an annuloplasty ring, even if degenerated, provides additional support for the most proximal and distal cell rows, both of which are flared outwards.

[0082] In a third aspect, the problem is solved by an introduction system for introducing a heart valve prosthesis into the heart of a patient, wherein the introduction system comprises a heart valve prosthesis according to the second aspect of the invention, an introduction catheter and a retractable outer sheath which, in a state in which the heart valve prosthesis is loaded onto the introduction catheter, holds the heart valve prosthesis in a crimped state, wherein the introduction system is configured such that - in the loaded and crimped state of the heart valve prosthesis, the first and second sections of the stent wire arm are not angled relative to each other and the intermediate section is not curved; and wherein - when retracting the outer sheath, the second end of the stent wire arm is first exposed, then the second section is folded outwards until a predetermined radius of the intermediate section is reached and the deflection element is formed, and when unfolding or bending the first section and after complete exposure of the stent wire arm, the deflection element is deflected or deflected in the direction of the central longitudinal axis so that the distance between the intermediate section and the central longitudinal axis of the heart valve prosthesis is less than the distance between the attachment point of the first end and the central longitudinal axis of the heart valve prosthesis.

[0083] Such an introduction system advantageously makes it possible to easily receive a native valve through the deflection element and to correct an unfavorable anatomy, i.e., an unfavorable position of the respective native valve.

[0084] In a preferred embodiment, the deflecting element deflects until it is angled relative to the distal end at an angle β of approximately 30° to 85°, preferably between approximately 50° and 85°, including each of the outer regions. In a further preferred embodiment, the deflecting element is angled relative to and in the direction of the distal end at an angle β of approximately 30° to 60°, preferably approximately 35° to 55°, preferably approximately 40° to 50°, and even more preferably approximately 42° to 48°, including the outer regions. In a preferred embodiment, the angle is approximately 45°.

[0085] In a preferred embodiment, the outer shell is retracted in the proximal direction.

[0086] This advantageously allows for the transseptal insertion of the heart valve prosthesis.

[0087] In a preferred embodiment, the insertion catheter further comprises a pull wire, wherein - the traction wire, in the state in which the heart valve prosthesis is loaded onto the delivery catheter, is detachably attached to the second end and exerts a tensile force on the stent wire arm, and - the outer shell is retracted or retractable in a distal direction and - the second section is folded outwards or foldable when the tensile force exerted by the pulling wire is reduced, and - after the second section is folded outwards, the second end is detached from the pulling wire.

[0088] This advantageously allows for transapical insertion of the heart valve prosthesis.

[0089] A fourth aspect describes a procedure for releasing a heart valve prosthesis from a delivery catheter according to the second aspect, which includes the use of the delivery system.

[0090] Such a procedure advantageously makes it possible to easily receive a native valve through the stent wire arm and to correct an unfavorable anatomy, i.e., an unfavorable position of the respective native valve.

[0091] In a preferred embodiment, the method is a method for treating a heart valve with a degenerated surgical annuloplasty ring (80) or a diseased native heart valve, wherein the diseased native valve is preferably a ring calcification of a heart valve, more preferably a ring calcification of a mitral heart valve. BRIEF DESCRIPTION OF THE FIGURES Fig. Figure 1 shows a heart valve prosthesis 10 in a side view. Fig. Figure 2 shows a heart valve prosthesis 100 in a side view. Fig. Figure 3 shows a heart valve prosthesis 100 that is implanted into the heart of a patient. Fig. Figure 4 shows an insertion system 200 for transseptal insertion of a heart valve 100 into the heart of a patient. Fig. Figure 5 shows an insertion system 300 for transapical insertion of a heart valve 100 into the heart of a patient. Fig. Figure 6 shows a pull wire 88 of an insertion system 300 in detail. DETAILED DESCRIPTION OF PREFERRED DESIGNS Heart valve prosthesis according to the first aspect

[0092] Fig. Figure 1 shows a heart valve prosthesis 10 in a side view.

[0093] The heart valve prosthesis 10 has a proximal end 12, a distal end 14, a central longitudinal axis 62, a stent frame 48 and a valve element 49 and has a lumen 16.

[0094] The heart valve prosthesis 10 is expandable between a radially crimped configuration and a radially expanded configuration. Fig. Figure 1 shows a radially expanded configuration.

[0095] The proximal end 12 forms a first opening through which a fluid can pass. In use, this first opening allows blood to pass through.

[0096] The distal end 14 forms a second opening through which a liquid can pass. In use, this second opening allows blood to pass through.

[0097] The lumen 16 has a luminal side 58 and an abluminal side 60 and extends tubularly through the stent frame 48, so that a fluid can enter the lumen 16 via the proximal end 12, pass through the lumen 16 and exit the lumen 16 via the distal end 14.

[0098] The lumen 16 extends tubularly through the heart valve prosthesis 10, so that a fluid can enter the lumen 16 via the proximal end 12, pass through the lumen 16 and exit the lumen 16 via the distal end 14.

[0099] The lumen side 58 faces the stent frame 48 towards the lumen 16. The lumen side 58 may be at least partially covered by a prosthetic material.

[0100] The abluminal side 60 faces away from the stent frame 48 and the lumen 16. The abluminal side 60 may be at least partially covered by a prosthetic material.

[0101] The central longitudinal axis 62 is defined perpendicularly through the lumen 16.

[0102] The stent frame 48 is formed from a multitude of adjacent cells. The multitude of adjacent cells is arranged in circumferential rows.

[0103] As the expert will know, at least some of the cells may be blocked, for example by a prosthetic material.

[0104] The multitude of neighboring cells exhibits a most proximal cell row 18, a most distal cell row 20 and at least one middle cell row 22.

[0105] The at least one middle cell row 22 is arranged between the most proximal cell row 18 and the most distal cell row 20.

[0106] In a preferred embodiment, 3 middle cell rows 22 are provided. In other preferred embodiments, 1 to 5 middle cell rows 22 may be provided.

[0107] Each cell of the at least one middle cell row 22 is essentially rhombus-shaped with a proximal apex 40, a distal apex 42, a right apex 44, and a left apex 46. The proximal apex 40 and the distal apex 42 are opposite each other longitudinally along the stent frame 48. The right apex 44 and the left apex 46 are opposite each other circumferentially along the stent frame 48. A right apex 44 of a first cell is connected to a left apex 46 of a second cell, which borders the first cell circumferentially along the stent frame 48.

[0108] The most proximal cell row 18 is located at the proximal end 12 and comprises a plurality of cells. The plurality of cells are arranged side by side and circumferentially around the lumen 16. Each cell of the most proximal cell row 18 can be of the same size and is formed by two proximal struts 24. Each proximal strut 24 has a first end 26 and a second end 28. The first ends 26 are connected to each other and form a most proximal vertex 30. The second ends 28 are connected to a proximal vertex 40, such that every second proximal vertex 40 is not connected to a second end 28 and is free from any connection to a second end 28.

[0109] The most proximal cell row 18 can be expanded outwards with respect to the lumen 16 of the heart valve prosthesis 10, with the first ends 26 being expanded outwards more steeply than the second ends 28. In other preferred embodiments, the most proximal cell row 18 can be expanded outwards uniformly, or the second ends 28 can be expanded outwards more steeply than the first ends 26.

[0110] The most distal cell row 20 is located at the distal end 14 and comprises a multitude of cells. These multiple cells are arranged side-by-side and circumferentially around the lumen 16. Each cell of the most distal cell row 20 can be of the same size and is formed by two distal struts 32. Each distal strut 32 has a first end 34 and a second end 36. The first ends 34 are connected to each other, forming a most distal vertex 38. The second ends 36 are connected to a distal vertex 42, such that every second distal vertex 42 is not connected to a second end 36 and is free from any connection to a second end 36.

[0111] The distal row of cells 22 can be expanded outwards with respect to the lumen 16 of the heart valve prosthesis 10, with the first ends 34 being expanded outwards more steeply than the second ends 36. In other preferred embodiments, the distal row of cells 22 can be expanded outwards uniformly, or the second ends 36 can be expanded outwards more steeply than the first ends 34.

[0112] In a preferred embodiment, the stent frame 48 can be balloon-expandable. In this embodiment, the stent frame 48 can be made of 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-expanding, the stent frame 48 can be made at least partially of a shape-memory material, preferably nitinol.

[0113] The flap element 49 is attached to the stent frame 48 within the lumen 16. The flap element 49 can be any flap element that is attached to the stent frame 48, at least as an intermediate element, within the lumen 16. A large number of applicable flap elements are known to those skilled in the art.

[0114] In preferred embodiments, the flap element 49 can have 1 to 4 flaps. Heart valve prosthesis according to the second aspect

[0115] Fig. Figure 2 shows a heart valve prosthesis 100 in a side view.

[0116] The heart valve prosthesis 100 has a proximal end 12, a distal end 14, a central longitudinal axis 62, a stent frame 48, a valve element 49 and a deflection element 50 and has a lumen 16.

[0117] The heart valve prosthesis 100 is expandable between a radially crimped configuration and a radially expanded configuration. Fig. Figure 1 shows the radially expanded configuration.

[0118] The proximal end 12 forms a first opening that allows the passage of a fluid. In use, this first opening allows the passage of blood.

[0119] The distal end 14 forms a second opening through which a liquid can pass. In use, this second opening allows blood to pass through.

[0120] The lumen 16 has a luminal side 58 and an abluminal side 60 and extends tubularly through the stent frame 48, so that a fluid can enter the lumen 16 via the proximal end 12, pass through the lumen 16 and exit the lumen 16 via the distal end 14.

[0121] The lumen 16 extends tubularly through the heart valve prosthesis 10, so that a fluid can enter the lumen 16 via the proximal end 12, pass through the lumen 16 and exit the lumen 16 via the distal end 14.

[0122] The lumen side 58 faces the stent frame 48 towards the lumen 16. The lumen side 58 may be at least partially covered by a prosthetic material.

[0123] The abluminal side 60 faces away from the stent frame 48 and the lumen 16. The abluminal side 60 may be at least partially covered by a prosthetic material.

[0124] The central longitudinal axis 62 is defined perpendicularly through the lumen 16.

[0125] The stent frame 48 is formed from a multitude of adjacent cells. The multitude of adjacent cells is arranged in circumferential rows.

[0126] As the expert will know, at least some of the cells may be blocked, for example by a prosthetic material.

[0127] The multitude of neighboring cells exhibits a most proximal cell row 18, a most distal cell row 20 and at least one middle cell row 22.

[0128] The at least one middle cell row 22 is arranged between the most proximal cell row 18 and the most distal cell row 20.

[0129] In a preferred embodiment, 3 middle cell rows 22 are provided. In other preferred embodiments, 1 to 5 middle cell rows 22 may be provided.

[0130] In a preferred embodiment, each cell of the at least one central cell row 22 can essentially have the shape of a rhombus with a proximal apex 40, a distal apex 42, a right apex 44, and a left apex 46. The proximal apex 40 and the distal apex 42 can be opposite each other in the longitudinal direction of the stent frame 48. The right apex 44 and the left apex 46 can be opposite each other in the circumferential direction of the stent frame 48. A right apex 44 of a first cell can be connected to a left apex 46 of a second cell, which is adjacent to the first cell in the circumferential direction of the stent frame 48.

[0131] In a preferred embodiment, the most proximal cell row 18 can be arranged at the proximal end 12 and comprise a plurality of cells. The plurality of cells can be arranged adjacent to one another and circumferentially around the lumen 16. Each cell of the most proximal cell row 18 can be of the same size and formed by two proximal struts 24. Each proximal strut 24 can have a first end 26 and a second end 28. The first ends 26 can be connected to each other and form a most proximal vertex 30. The second ends 28 can be connected to a proximal vertex 40, such that every second proximal vertex 40 is not connected to a second end 28 and is free from any connection to a second end 28.

[0132] In a preferred embodiment, the most proximal cell row 18 can be expanded outwards with respect to the lumen 16 of the heart valve prosthesis, wherein the first ends 26 can be expanded outwards more steeply than the second ends 28. In other preferred embodiments, the most proximal cell row 18 can be expanded outwards uniformly, or the second ends 28 can be expanded outwards more steeply than the first ends 26.

[0133] In a preferred embodiment, the most distal cell row 20 can be arranged at the distal end 14 and comprise a plurality of cells. The plurality of cells can be arranged adjacent to one another and circumferentially around the lumen 16. Each cell of the most distal cell row 20 can be of the same size and formed by two distal struts 32. Each distal strut 32 can have a first end 34 and a second end 36. The first ends 34 can be connected to each other and form a most distal vertex 38. The second ends 36 can be connected to a distal vertex 42, such that every second distal vertex 42 is not connected to a second end 36 and is free from any connection to a second end 36.

[0134] In a preferred embodiment, the most distal row of cells 22 can be expanded outwards with respect to the lumen 16 of the heart valve prosthesis, with the first ends 34 being expanded outwards at a steeper angle than the second ends 36. In other preferred embodiments, the most distal row of cells 22 can be expanded outwards uniformly, or the second ends 36 can be expanded outwards at a steeper angle than the first ends 34.

[0135] In a preferred embodiment, the stent frame 48 can be balloon-expandable. In this embodiment, the stent frame 48 can be made of 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-expanding, the stent frame 48 can be made at least partially of a shape-memory material, preferably nitinol.

[0136] The flap element 49 is attached to the stent frame within the lumen 16. The flap element 49 can be any flap element that is at least temporarily attached to the stent frame 48 within the lumen 16. A large number of applicable flap elements are known to those skilled in the art.

[0137] In preferred embodiments, the flap element 49 can have 1 to 4 flap sails.

[0138] In other preferred embodiments, the stent frame 48 can be any stent frame that is provided with or connected to sufficient anchoring means to anchor the heart valve prosthesis 100 in its desired position within the respective heart valve. A variety of suitable stent frames 48 are known to those skilled in the art.

[0139] The deflection element 50 is formed by a stent wire arm.

[0140] The stent wire arm has a first end 64, a first section 74, an intermediate section 66, a second section 78 and a second end 68.

[0141] The stent wire arm is self-expanding from a crimped configuration to an expanded configuration and extends beyond the distal end 14 of the heart valve prosthesis 100 with the first section 74, the intermediate section 66, the second section 78 and the second end 68. Fig. Figure 2 shows the stent wire arm in an expanded configuration.

[0142] The first end 64 is connected to the stent frame 48 at a distal vertex 42 and forms at least one attachment point 70. A single attachment point 70 may be provided. In such an embodiment, the stent wire arm may be a single stent wire. The single attachment point 70 may be elongated.

[0143] In other preferred embodiments, multiple attachment points 70 may be provided. For example, the stent wire arm may be a stent wire forming a loop, such that both ends of the looping stent wire, i.e., the first end 64, are attached to the stent frame 48 and form at least one attachment point 70, in which case the first end 64 is preferably attached to the stent frame 48 and forms two attachment points 70. The stent wire arm may also be a branched stent wire. Alternatively, the stent wire arm may be a scaffold or network of multiple stent wires attached to the stent frame 48 and forming at least one attachment point 70.

[0144] In these and other preferred embodiments, the first end 64 can be connected to the abluminal side 60. In other preferred embodiments, the first end 64 can be connected to the stent frame 48 at the luminal side 58, the abluminal side 60, the distal end 14, or a combination of the aforementioned locations, preferably at the distal end 14 or at the distal end 14 and the abluminal side 58.

[0145] In preferred embodiments, the at least one fastening point 70 can be of any type. Preferably, the fastening point 70 is elongated, circular, annular or polygonal, more preferably elongated, circular or rectangular.

[0146] The fastening can be achieved, for example, by welding, gluing, crimping, or sewing. In other preferred embodiments, the fastening can be achieved by manufacturing the stent frame 48 and the stent wire arm from a single piece.

[0147] The first section 74 is arranged distal to the distal end 14 and between the first end 64 and the intermediate section 66. The first section 74 can extend distally from the first end 64 and maintain a distance between the intermediate section 66 and the at least one attachment point 70. In a preferred embodiment, the distance is 10 mm to 30 mm.

[0148] In a preferred embodiment, the first section 74 is angled relative to and towards the distal end 14 at an angle β of 60°. In other preferred embodiments, the angle β can be between 30° and 85°, between approximately 30° and 60°, between approximately 35° and 55°, between approximately 40° and 50°, and between 42° and 48°, with the outer regions being the respective points. In a preferred embodiment, the angle is approximately 45°.

[0149] The intermediate section 66 is arranged distal to the distal end 14 and between the first end 64 and the second end 68 and is curved with a preset radius, at least in the expanded configuration. The preset radius can be 5 mm. In other preferred embodiments, the preset radius can be between 1 mm and 10 mm.

[0150] At least in the expanded configuration, the distance between the intermediate section 66 and the central longitudinal axis 62 is smaller than the distance between the at least one attachment point 70 and the central longitudinal axis 62.

[0151] The second section 78 is arranged distal to the distal end 14 and between the intermediate section 66 and the second end 68. The second section 78 may extend proximal to the intermediate section 66 and be shorter than the first section 74. In other preferred embodiments, the second section 78 may be the same length as or longer than the first section 74. Most preferably, the second section 78 is approximately the same length as the first section 74.

[0152] In a preferred embodiment, the second section 78 is angled relative to the first section 74 at an angle α of 190°. In other preferred embodiments, the angle α can be between 120° and 210°, preferably between 150° and 190°.

[0153] The second end 68 is not connected to the stent frame 48 except 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 have a retaining device or holder configured to be engaged by a lead wire of an introducer catheter and / or detachably connected to it.

[0154] The holder can be a circular stent wire, for example a loop, or a bent section of a stent wire.

[0155] At least in the expanded configuration, the deflection element 50 is designed to receive a native valve due to the arrangement of the first section 74, the intermediate section 66, and the second section 78. In preferred embodiments, the first section 74, the intermediate section 66, and the second section 78 together form the deflection element 50, which is U-, V-, J-, or groove-shaped.

[0156] Fig. Figure 3 shows the heart valve prosthesis 100, which is implanted into the heart of a patient.

[0157] In this embodiment, the heart valve prosthesis 100 can be implanted into a human mitral valve that has a degenerated surgical annuloplasty ring 80. The deflection element 50 can accommodate the anterior mitral valve 82.

[0158] In other preferred embodiments, the heart valve 100 is intended for implantation in or use in the treatment of a heart valve that has a degenerated surgical annuloplasty ring or a diseased native heart valve. More preferably, the diseased native heart valve is an annular calcification of a heart valve, more preferably an annular calcification of an atrioventricular heart valve, and most preferably an annular calcification of a mitral valve.

[0159] In other preferred embodiments, the heart valve 100 can be provided for implantation in or use in the treatment of any diseased heart valve, wherein the disease is preferably mitral valve regurgitation causing regurgitation, and the heart valve is preferably a human heart valve, more preferably a human atrioventricular heart valve, most preferably a human mitral valve.

[0160] In preferred embodiments, in which the most proximal cell row 18 and the most distal cell row 20 are expanded outwards, the heart valve prosthesis 100 can be implanted such that the degenerated annuloplasty ring 80 or the calcified annulus is positioned between the outwardly expanded most proximal cell row 18 and the outwardly expanded most distal cell row 20 and circumferentially around the at least one middle cell row 22. Delivery system for a heart valve prosthesis according to the second aspect

[0161] Fig. Figure 4 shows an insertion system 200 for transseptal insertion of a heart valve 100 into the heart of a patient.

[0162] The delivery system 200 includes a heart valve prosthesis 100 and a delivery catheter 84 and has a loaded state, a first release state and a second release state.

[0163] The insertion catheter 84 has a retractable outer sheath 86.

[0164] The introducer catheter 84 can be loaded with the heart valve prosthesis 100. Various techniques for loading an introducer catheter with a heart valve prosthesis are known to those skilled in the art.

[0165] The outer shell 86 can be retracted in the proximal direction of the heart valve prosthesis 100.

[0166] Fig. Figure 4A shows an insertion system 200 in the charged state.

[0167] In the loaded state, the heart valve prosthesis 100 is loaded onto the delivery catheter 84 in a radially crimped configuration, enclosed by the outer sheath 86, and the deflection element 50 is in a crimped configuration, wherein the first section 74 and the second section 78 are not angled relative to each other and the intermediate section 66 is not curved with the preset radius, but unfolded or extended. The outer sheath 86 can hold the deflection element 50 in the crimped configuration.

[0168] In other preferred embodiments, the deflecting element 50 can be held in the crimped configuration by any means.

[0169] Fig. Figure 4B shows an introduction system 200 in the first release state.

[0170] In the first release state, the outer shell 86 can be completely retracted from the heart valve prosthesis 100, and the deflection element 50 is in a folded configuration, with the intermediate section 66 curved to the preset radius.

[0171] In other preferred embodiments, in the first release state, the outer shell 86 is at least partially retracted from the heart valve prosthesis 100. For example, the outer shell 86 can partially or completely enclose the stent frame 48.

[0172] Fig. Figure 4C shows an introduction system 200 in the second release state.

[0173] In the second release state, the outer shell 86 is retracted from the heart valve prosthesis 100, the stent frame 48 can be expanded into the radially expanded configuration, and the deflection element 50 is in the expanded configuration with the deflection element deflected.

[0174] 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 yet have reached its final radial extent.

[0175] Fig. Figure 5 shows an insertion system 300 for transapical insertion of a heart valve 100 into the heart of a patient.

[0176] 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.

[0177] The insertion catheter 84 has a retractable outer sheath 86.

[0178] The introducer catheter 84 can be loaded with the heart valve prosthesis 100. Various techniques for loading an introducer catheter with a heart valve prosthesis are known to those skilled in the art.

[0179] The outer shell 86 can be retracted distally to the heart valve prosthesis 100.

[0180] The pull wire 88 can be detachably connected to the second end 68 and has a tensioned state and a relaxed state.

[0181] Fig. Figure 6 shows a pull wire 88 of an insertion system 300 in detail.

[0182] The pull wire 88 can have a sheath 90 and a wire 92.

[0183] The sheath 90 can partially enclose the wire 92 and extend within the outer sheath 86.

[0184] The wire 92 can have a first end and a second end.

[0185] The first end of the wire 92 is connected to the delivery catheter 84 and can be retracted or coiled to exert a traction force in a distal direction on the wire 92.

[0186] The second end of the wire 92 can be detachably attached to the second end 68 or to the introducer catheter 84 in order to further exert the tensile force exerted on the wire 92 via the first end onto the stent wire arm.

[0187] The releasable attachment at the second end 68 can be achieved, for example, by passing the wire 92 through or around a holder with the second end of the wire 92 and releasably attaching it to the introducer catheter 84, or by providing the second end of the wire 92 with a hook, a barb or other gripping device suitable for releasable attachment to the second end 68.

[0188] Fig. Figure 6A shows the tension wire 88 in the tensioned state. The tension wire 88 is detachably connected to the second end 68, exerts a tensile force on the stent wire arm, and holds the deflection element 50 in the crimped configuration.

[0189] Fig. 6B and Fig. Figure 5B shows the tension wire 88 in its relaxed state. In the embodiment of Fig. 6B the outer sheath 86 is retracted, and the pull wire 88 is detachably attached to the second end 68 and holds the deflecting element 50 in a configuration in which the intermediate section 66 is curved. In the embodiment of Fig. 6C and Fig. 5B is the outer shell 86 (in Fig. (6C not shown) withdrawn, the pull wire 88 is not attached to the second end 68, and the intermediate section 66 is curved with the preset radius.

[0190] Fig. Figure 5A shows an insertion system 300 in a charged state.

[0191] In the loaded state, the heart valve prosthesis 100 is loaded onto the delivery catheter 84 in a radially crimped configuration, enclosed by the outer sheath 86, and the deflection element 50 is in a crimped configuration, with the first section 74 and the second section 78 not angled relative to each other and the intermediate section 66 not curved, unfolded, or extended with the preset radius. The pull wire 88 is in a tensioned state and can hold the deflection element 50 in the crimped configuration.

[0192] In other preferred embodiments, the deflecting element 50 can be held in the crimped configuration by any means.

[0193] Fig. Figure 5B shows an introduction system 300 in the first release state.

[0194] In the first release state, the outer shell 86 can be completely retracted from the heart valve prosthesis 100, and the deflection element 50 is in the folded configuration, with the intermediate section 66 curved with the preset radius.

[0195] In other preferred embodiments, in the first release state the outer shell 86 is at least partially withdrawn from the heart valve prosthesis 100.

[0196] Fig. Figure 5C shows an introduction system 300 in the second release state.

[0197] In the second release state, the outer shell 86 is retracted from the heart valve prosthesis 100, the heart valve prosthesis 100 can be expanded into the radially expanded configuration and the deflection element 50 is in the expanded configuration.

[0198] 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 yet have reached its final radial extent. Method for releasing a heart valve prosthesis according to the second aspect from an introduction system for introducing a heart valve prosthesis according to the second aspect

[0199] A procedure 400 for releasing the heart valve prosthesis 100 from an introducing catheter is in Fig. 4 is shown as an example. Procedure 400 has steps a), b), c) and d).

[0200] The introducer catheter 84, from which the heart valve prosthesis 100 is to be released, can be the introducer catheter 84 of the introducer system 200. In other preferred embodiments of the method 400, the introducer catheter can be any introducer 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 deflection element 50 is in a crimped configuration, wherein the introducer catheter has a retractable outer sheath.

[0201] In step a), the outer sheath 86 is at least partially retracted so that the second end 68 of the stent wire arm is exposed. The outer sheath 86 can be retracted in a proximal direction. In other preferred embodiments, the outer sheath 86 can be retracted in a distal direction.

[0202] In step b), the second section 78 folds or expands outwards, i.e., towards the abluminal side 60, until a preset radius of the intermediate section 66 is reached and the deflecting element 50 is formed. Step b) can be performed after completion of step a) or before completion of step a), i.e., at least partially simultaneously with step a).

[0203] In embodiments in which the heart valve prosthesis 100 is to be released from the introducer catheter 84 of the introducer system 200, the second section 78 can preferably begin unfolding or expanding with at least partial retraction of the outer sheath 86, i.e. step b) can be carried out before completion of step a).

[0204] In step c), the stent wire arm is fully exposed, i.e., the outer sheath 86 is completely withdrawn from the stent wire arm. As will be clear to those skilled in the art, before the heart valve prosthesis 100 is expanded, the outer sheath 86 must be completely withdrawn from the stent frame 48. Various techniques for expanding a stent frame during its release from a delivery catheter are known to those skilled in the art.

[0205] In step d), the deflecting element 50 is to be deflected in the direction of the central longitudinal axis 62 such that the distance between the intermediate section 66 and the central longitudinal axis 62 is smaller than the distance between the attachment point 70 and the central longitudinal axis 62. Step d) can be carried out after completion of step c) or before completion of step c), i.e., at least partially simultaneously with step c).

[0206] In embodiments in which the introducer catheter from which the heart valve prosthesis 100 is to be released is the introducer catheter 84 of the introducer system 200, the deflection element 50 can preferably begin deflecting with at least partial expansion of the stent frame 48, i.e. step d) can be carried out before completion of step c).

[0207] A procedure 500 for releasing the heart valve prosthesis 100 from an introducer catheter is in the Fig. 5 and Fig. Figure 6 is shown as an example. Procedure 500 includes steps a), aa), b), bb), c) and d).

[0208] The introducer catheter from which the heart valve prosthesis 100 is to be released can be the introducer catheter 84 of the introducer system 300. In other preferred embodiments of the method, the introducer catheter can be any introducer 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 deflection element 50 is in a crimped configuration, wherein the introducer catheter has a retractable outer sheath and a pull wire that is detachably connected to the second end 68 and exerts a tensile force on the stent wire arm at least when the outer sheath is retracted.

[0209] In step a), the outer sheath 86 can be completely retracted, exposing the second end 68 of the stent wire arm. The outer sheath 86 can be retracted distally. In other preferred embodiments, the outer sheath can be retracted proximally.

[0210] In step aa) the tensile force exerted by the pull wire 88 on the stent wire arm can be reduced, i.e. the pull wire is transferred from the tensioned state to the relaxed state.

[0211] In step b), the second section 78 is bent or deflected outwards, i.e., towards the abluminal side 60, until a predetermined radius of the intermediate section 66 is reached and the deflection element 50 is formed. Step b) can be carried out after completion of step aa) or before completion of step aa), i.e., at least partially simultaneously with step aa).

[0212] In embodiments in which the introducer catheter from which the heart valve prosthesis 100 is to be released is the introducer catheter 84 of the introducer system 300, the second section 78 can preferably begin to fold with a reduction of the traction force exerted by the traction wire 88, i.e. step b) can be carried out before the completion of step aa).

[0213] In step bb), the second end 68 can be detached from the pull wire 88. This can be done by detaching the first end of the wire 92 from the introducer catheter 84. In embodiments where the first end of the wire 92 is detachably 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.

[0214] In step c), the stent wire arm is completely exposed, i.e., the outer sheath 86 is completely withdrawn from the stent wire arm. As will be clear to those skilled in the art, before expanding the heart valve prosthesis 100, the outer sheath 86 must be completely withdrawn from the stent frame 48. Various techniques for expanding and releasing a stent frame or stent scaffold from a delivery catheter are known to those skilled in the art.

[0215] In step d), the deflecting element 50 is deflected in the direction of the central longitudinal axis 62 such that the distance between the intermediate section 66 and the central longitudinal axis 62 is smaller than the distance between the attachment point 70 and the central longitudinal axis 62. Step d) can be carried out after completion of step c) or before completion of step c), i.e., at least partially simultaneously with step c).

[0216] In embodiments in which the introducer catheter from which the heart valve prosthesis 100 is to be released is the introducer catheter 84 of the introducer system 300, the deflection element 50 can preferably begin the deflection with at least partial expansion of the stent frame 48, i.e. step d) can be carried out before completion of step c). QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] US 11,633,278 B2

[0007] EP 3 760 165 A1

[0008] US 2014 / 0046426 A1

[0009]

Claims

[1] Heart valve prosthesis (10) for implantation into the heart of a patient, wherein the heart valve prosthesis (10) is expandable between a radially compressed configuration and a radially expanded configuration, and has a lumen (16) with 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 which has a stent frame (48) and a valve element (49) 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 has a most proximal cell row (18) at the proximal end (12) and a most distal cell row (20) at the distal end (14), and at least one intermediate cell row (22) arranged between the most proximal cell row (18) and the most distal cell row (20), wherein - each cell of the at least one middle cell row (22) substantially in the shape of a rhombus with a proximal apex (40) and a distal apex (42) opposite each other in the longitudinal direction of the stent frame (48), and with a right apex (44) and a left apex (46) opposite each other in the circumferential direction of the stent frame (48), wherein a right apex (44) of a first cell in the at least one middle cell row (22) is connected to a left apex (46) of a second cell which is circumferentially adjacent to the first cell of the middle cell row (22), and wherein - each cell of the most proximal cell row (18) is formed by two proximal struts (24), each having a first end (26) and a second end (28), wherein the first ends (26) of the two proximal struts (24) are connected to each other and form a most proximal vertex (30), and each end of the second ends (28) of the two proximal struts is connected to a proximal vertex (40) of a cell of the middle cell row (22) adjacent to the most proximal cell row (18), such that a proximal vertex (40) of a cell of the middle cell row of cells (22) adjacent to the most proximal cell row (18) is not connected to the second ends (28) and is free from any connection with them, and wherein each cell of the most distal cell row (20) is formed by two distal struts (32), each having a first end (34) and have a second end (36),wherein the first ends (34) of the two distal struts (32) are connected to each other and form a distal apex (38), and each end of the second ends (36) of the two distal struts (34) is connected to a distal apex (42) of a cell of the middle cell row (22) adjacent to the distal cell row (20), wherein a distal apex (42) of a cell of the middle cell row (22) adjacent to the distal cell row (20) is not connected to the second ends (36) and is free from any connection with them. [2] The heart valve prosthesis (10) according to claim 1, wherein the most proximal cell row (18) and the most distal cell row (20) are each expanded outwards with respect to the lumen (16) of the heart valve prosthesis (10). [3] Heart valve prosthesis (10) according to one of the preceding claims, comprising between 1 and 5 intermediate cell rows (22). [4] Heart valve prosthesis (100) for implantation into the heart of a patient, wherein the heart valve prosthesis (100) is expandable between a radially compressed configuration and a radially expanded configuration and has a lumen (16) with 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 a stent frame (48) and a valve element (49) which is 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 has a most proximal cell row (18) at the proximal end (12) and a most distal cell row (20) at the distal end (14), and at least one intermediate cell row (22) arranged between the most proximal cell row (18) and the most distal cell row (20), and wherein the heart valve prosthesis (100) further comprises - a deflection element (50) to prevent a native valve from obstructing ventricular outflow, wherein the deflection element (50) is formed by a stent wire arm that is self-expanding and can be expanded from a crimped configuration to an expanded configuration, and which has a first end (64), a first section (74), an intermediate section (66), a second section (78) and a second end (68), - wherein the stent wire arm is attached to the stent frame (48) via its first end (64), forming at least one attachment point (70), and extends beyond the distal end (14) of the heart valve prosthesis (100) with its first section (74), intermediate section (66), second section (78) and second end (68), wherein the second end (68) is not attached to the stent frame (48), and wherein - the first section (74), the intermediate section (66) and the second section (78) are configured to form the deflection element (50) for receiving the native valve, and - wherein the distance between the intermediate section (22) and the central longitudinal axis (62) of the heart valve prosthesis (100) is less than the distance between the at least one attachment point (70) of the first end and the central longitudinal axis (62) of the heart valve prosthesis (100). [5] Heart valve prosthesis (100) according to claim 4, wherein the deflection element (50) is designed such that the intermediate section (22) is curved with a predetermined radius, whereby the first section (74) generally extends in a distal direction or away from the distal end (14), and the second section (78) extends substantially in a proximal direction or towards the distal end (14). [6] Heart valve prosthesis (100) according to claim 4 or 5, wherein the deflection element (50) is angled with respect to the central longitudinal axis (62) at an angle β between 30° and 85° relative to the distal end (14) and in the direction of the distal end (14). [7] Heart valve prosthesis (100) according to one of claims 4 to 6, wherein the first section (74) and the second section (78) are angled at an angle α between 120° and 210°. [8] Heart valve prosthesis (100) according to any one of claims 4 to 7, wherein the first end (64) of the stent wire arm is attached to the abluminal side (60) or the luminal side (58) or to a most distal point of the most distal cell row (20) or a combination of the aforementioned locations. [9] Heart valve prosthesis (100) according to any one of claims 4 to 8, wherein each cell of the at least one middle cell row (22) has essentially the shape of a rhombus with a proximal apex (40) and a distal apex (42) opposite each other in the longitudinal direction of the stent frame (48), and with a right apex (44) and a left apex (46) opposite each other in the circumferential direction of the stent frame (48), wherein a right apex (44) of a first cell in the at least one middle cell row (22) is connected to a left apex (46) of a second cell which is circumferentially adjacent to the first cell of the middle cell row (22), and wherein Each cell of the most proximal cell row (18) is formed by two proximal struts (24), each having a first end (26) and a second end (28), wherein the first ends (26) of the two proximal struts (24) are connected to each other and form a most proximal vertex (30), and each end of the second ends (28) of the two proximal struts (24) is connected to a proximal vertex (40) of a cell of the middle cell row (22) adjacent to the most proximal cell row (18), such that a proximal vertex (40) of a cell of the middle cell row (22) adjacent to the most proximal cell row (18) is not connected to the second ends (28) and is free from any connection with them, and wherein Each cell of the most distal cell row (20) is formed by two distal struts (32), each having a first end (34) and a second end (36), wherein the first ends (34) of the two distal struts (32) are connected to each other and form a most distal vertex (38), and each end of the second ends (36) of the two distal struts (32) is connected to a distal vertex (42) of a cell of the middle cell row (22) adjacent to the most distal cell row (20), wherein a distal vertex (42) of a cell of the middle cell row (22) adjacent to the most distal cell row (20) is not connected to the second ends (36) and is free from any connection with them. [10] Heart valve prosthesis (100) according to any one of claims 4 to 9, wherein the most proximal cell row (18) and the most distal cell row (20) are each expanded outwards with respect to the lumen (16) of the heart valve prosthesis (100). [11] Heart valve prosthesis according to one of claims 4 to 10, comprising intermediate cell rows (22) between 1 and 5. [12] Heart valve prosthesis (100) according to one of the preceding claims, wherein the valve element (49) has between 1 and 4 leaflets. [13] Heart valve prosthesis (100) according to 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 by inflating a balloon. [14] Heart valve prosthesis (100) according to any of the preceding claims, which is a mitral valve prosthesis. [15] Heart valve prosthesis (100) according to any of the preceding claims for implantation in or use in the treatment of a heart valve with a degenerated surgical annuloplasty ring (80) or a diseased native heart valve, wherein the diseased native valve is preferably an annularly calcified heart valve, more preferably an annularly calcified mitral heart valve. [16] 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 one of claims 4 to 15, a delivery catheter (84), wherein the delivery catheter (84) has a retractable outer sheath (86) which, in a state in which 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 and crimped state of the heart valve prosthesis (100), the first section (74) and the second section (78) of the stent wire arm are not angled relative to each other, and the intermediate section (22) is not curved; and wherein - when retracting the outer sheath (86), first the second end (68) of the stent wire arm is exposed, then the second section (78) is bent outwards until a predetermined radius of the intermediate section (66) is reached and the deflection element (50) is formed, and when bending outwards of the second section (78) and after complete exposure of the stent wire arm, the deflection element (50) is deflected in the direction of the central longitudinal axis (62) such that a distance between the intermediate section (22) and the central longitudinal axis (62) of the heart valve prosthesis (100) is less than a distance between the attachment point (70) of the first end (64) and the central longitudinal axis (62) of the heart valve prosthesis (100), wherein preferably the deflection element (50) is angled relative to and in the direction of the distal end (14) at an angle β between 30° and 85°. [17] Insertion system (200) according to claim 16, wherein the outer sheath (86) is retractable in a proximal direction. [18] Introduction system (300) according to claim 16, wherein the introduction catheter (84) further comprises a pull wire (88), wherein - the traction wire (88) in the state in which the heart valve prosthesis (100) is loaded onto the delivery catheter (84), is detachably attached to the second end (68) and exerts a traction force on the stent wire arm, and - the outer shell (86) is retractable in a distal direction, and - the second section (78) folds outwards when the tensile force exerted by the pulling wire (88) is reduced, and - after unfolding the second section (78) the second end (68) is detached from the pull wire.

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