Prosthetic heart valve system

Abstract

The invention relates to a prosthetic heart valve system (10) comprising a stent graft component (12), and a valve component (16). The valve component (16) comprises a stent frame (17) and a valve member (18), the stent frame (17) comprising an annulus section (22), an aortic section (23), and an intermediate section (24) located between the annulus section (22) and the aortic section (23). A cell area ratio of a cell area of a cell (50) in the row (19b) of cells in the intermediate section (24) to a cell area of a cell (30) in the row (19a) of cells in the annulus section (22) and / or of a cell (40) in the row (19c) of cells in the aortic section (23) is at least from about 2:1, preferably 3.:1, to about 5:1.

Description

Prosthetic heart valve systemFIELD OF THE INVENTION

[0001] The present invention relates to a prosthetic heart valve system designed for implantation in the human cardiovascular system, specifically for replacing or repairing diseased native vessels and / or valves. The system is particularly well-suited for transcatheter procedures, enabling minimally invasive implantation. The prosthetic heart valve system comprises both a stent graft component and a valve component, which work together to restore the intended functions within the cardiovascular system. In particular, the present invention relates to a prosthetic heart valve system and a method for endovascular aortic treatment using the prosthetic heart valve system, including repair of diseased aortic valve, aortic stenosis, ascending aortic aneurysms, aortic insufficiency, aortic regurgitation, bicuspid valve disease, and / or aortic dissections.BACKGROUND

[0002] Heart valve disease, particularly aortic valve disease, is a leading cause of cardiovascular-related deaths. Aortic stenosis, the narrowing of the aortic valve, and aortic regurgitation, where the valve fails to close properly, can both disrupt the heart's function, leading to heart failure if untreated. Aortic stenosis, in particular, is prevalent among aging populations, making it a significant public health concern.

[0003] Traditional treatment options for aortic valve disease include mechanical or biological valve replacement via open-heart surgery. However, these procedures carry inherent risks, especially for elderly or high-risk patients. Moreover, mechanical valves necessitate lifelong anticoagulation therapy to prevent thromboembolic events, while biological valves, although offering more natural hemodynamics, are prone to tissue degeneration and calcification over time.

[0004] In recent years, transcatheter aortic valve replacement (TAVR) has emerged as a minimally invasive alternative to traditional surgery. This approach allows for the implantation of prosthetic aortic valves through catheter-based techniques, offering significant advantages in terms of recovery time and reducing the overall risks associated with open surgery. However, current TAVR devices still face challenges related to valve durability, paravalvular leakages, and suitability for various anatomical profiles, in particular considering the challenges for maintaining the coronary blood flow.SUMMRAY OF THE INVENTION

[0005] The present invention provides an improved prosthetic heart valve system, which is specifically suitable for the combination of the treatment of a diseased aorta and the replacement of the native aortic valve, addressing the limitations associated with both surgical and transcatheter aortic valve replacement methods known in the art. Also, this system is adaptable for both traditional surgical replacement and minimally invasive TAVR procedures.

[0006] The invention also includes methods for the secure implantation of the prosthetic heart valve (aortic) system, whether through open-heart surgery or minimally invasive transcatheter approaches.

[0007] By addressing the shortcomings of current aortic valve replacement technologies, this invention offers a robust solution for patients suffering from aortic valve diseases. It holds the potential to extend the lifespan of prosthetic valves, reduce postprocedural complications, and improve overall patient outcomes.

[0008] According to the invention, the prosthetic heart valve system comprises an outflow end and an inflow end, a valve component that is generally tubular and comprising a stent frame and a valve member, the stent frame having a radially collapsed configuration and a radially expanded configuration, and wherein the stent frame comprises a plurality of rows of cells formed by struts, e.g., a first, a second, a third and a fourth strut, joined to each other at intersection points, the cells being arranged adjacent to oneanother and extending around a circumference c of the stent frame, wherein the stent frame comprises an annulus section, an aortic section, and an intermediate section located between the annulus section and the aortic section, wherein the intermediate section is formed of / comprised of one row of cells, and wherein, in the radially expanded configuration, a cell area ratio of a cell in the row of cells in the intermediate row to a cell area ratio of a cell in the row of cells in the annulus section and / or the aortic section is at least from about 2:1, preferably 3:1, to about 5:1 ; the system optionally comprises a stent graft component that is generally tubular and has a longitudinal axis, and comprising a stent element and a graft element covering the stent element.

[0009] In other words, the cell area ratio between a cell in the row of cells in the intermediate section and a cell area of a cell in the row of cells in the annulus section and / or the aortic section is at least from about 2: 1 , preferably at least about 3: 1 , preferably at least about 4:1 and preferably at least 5:1.

[0010] The prosthetic heart valve system of the invention comprises both a stent graft component and a valve component, which work together to provide structural support and proper functioning of the complex within the cardiovascular system.

[0011] As discussed above, the prosthetic heart valve system is particularly designed for replacement of a native aortic valve, which is why the prosthetic heart valve system of the invention can also be designated as prosthetic aortic valve system. Where applicable, the system of the invention, or essential features thereof, can also be applied for replacement of other valves of a heart of a mammal.

[0012] The stent graft component of the system is generally tubular and is comprised of a stent element and a graft element. This structure provides a stable yet flexible scaffold that ensures proper placement and anchoring within the aorta. The stent element forms the backbone of the structure, while the graft element covers and protects it, ensuring compatibility with surrounding tissues. The stent graft element is designed for covering a section of the aorta, and, where appropriate, for sealing one or multiple entry and re-entry tears of a dissection.

[0013] The valve component, also generally tubular in structure, comprises a stent frame and a valve member.

[0014] The prosthetic heart valve, via the stent frame and stent element, can transition between a radially collapsed configuration, for being loaded on a catheter and for delivery through vessels, and a radially expanded configuration, for firm anchoring within the cardiovascular system. A key feature of the prosthetic heart valve is the cellular structure of the stent frame of the valve component, which extend circumferentially around the stent frame, enabling a flexible yet stable expansion. The valve component stabilizes the aortic root and replaces the aortic valve.

[0015] The stent frame in the expanded configuration of the valve component includes distinct sections: an annulus section, an aortic section, and an intermediate section between the two. According to the definition set forth herein, the intermediate section is formed by one (1) row of cells. Accordingly, throughout the description, whenever the intermediate section is described or designated, this is to be understood as also to refer to the (one) intermediate row. Also, analogously, it is to be understood, that the annulus section is comprised of / defined respective row(s) of cells, and that the aortic section is comprised of / defined by respective row(s) of cells.

[0016] Both the annulus and aortic sections, as such, have larger diameters compared to the intermediate section, which allows for optimal fitting within the heart. The intermediate section, or rather the row of cells forming the intermediate section while having a smaller diameter, is distinguished by its larger cells, with a cell area ratio compared to the smaller cells of the annulus and / or aortic section ranging from 2:1 to 5:1. This design optimizes flexibility and ensures that the valve can expand appropriately while maintaining its structural integrity, and furthermore allows the prosthetic heart valve to remain pervious to the coronary flow.

[0017] Presently, and as generally understood, the term “cell area” refers to the two-dimensional surface area enclosed by the interconnected struts that form the spaces (cells) within a lattice structure of the stent frame. E.g., if the cell is about rhomboid, thecell is considered to be formed of four struts being interconnected at four interesting points. Accordingly, the stent frame is a mesh-like device used to support or hold open blood vessels, and the lattice is composed of repeating units or patterns, i.e.: “cells”, formed by the struts. By defining that the cell area ratio between a cell area of a cell in the row of cells in the intermediate row and a cell area of a cell in the row of cells in the annulus section and / or a cell in the aortic section is at least from about 2:1 , preferably 3:1 , to about 5:1 , it is implied that the cell area of the cell of the row of cells of the intermediate section is at least about twice as large, or about three-times, or about four-times or about 5 times larger than the cell area of a cell of the row of cells of the annulus and / or of the aortic section.

[0018] Preferably, the cell in the intermediate section is at least from about 2:1 , preferably 3:1 , to about 5:1 , i.e., at least about twice as large, or about three-times, or about four-times or about 5 times larger than each of the cells of the annulus and aortic section.

[0019] Generally, and within the present invention, the term “about” shall acknowledge that the number specified therewith may not be exact but close to the stated value. It allows for reasonable variation or approximation while still encompassing the invention's core technical aspects. Presently, that means, that the cell area of a / all cell(s) of the intermediate section does not need to be exactly twice, three-, four- or five-times larger, but also, e.g., 2,1-times, 2,2-times, 2,3-times, 2,4-times, 2,5-times, 2,6-times, 2,7- times, 2,8-times, 2,9-times, 3,1 -times, 3,2-times, 3,3-times, etc., larger.

[0020] The cell area can be measured, e.g., via manual measurement using microscopic imaging, where a high-resolution image of the stent lattice using a microscope, such as an optical or electron microscope, is obtained. An image analysis software (such as Imaged, CAD, or similar) can be used to outline the boundaries of the cell within the image, and a software can calculate the enclosed area based on the image’s pixel scale. Measurements can be accurately converted to real-world units (e.g., square millimeters). Alternatively, a CAD model analysis can be used, based on a computer-aided design model of the stent frame, employing the CAD software. By selecting the cell structure and using built-in measurement tools one can calculate the enclosed area in the unit of choice(e.g., mm2). Also, alternatively, a 3D optical profilometer or a laser scanner is used to create a detailed surface profile of the stent frame and a 3D model of the stent frame lattice based on the scan data is generated. Analysis software is used to measure the area of each cell by selecting the boundaries of the cells in the 3D model. Using one of these methods, one can accurately measure the cell area of a cell of the respective cell sections and directly compare their cell areas.

[0021] According to one aspect of the invention, the aortic section and the annulus section, in the radially expanded configuration, have a larger diameter than the intermediate section.

[0022] With the diameter of the aortic and annulus section being larger than the diameter of the intermediate row, a general form of the valve component or rather the stent frame is generated, which is generally “hourglass”-shaped. In other words, the intermediate row, thus, forms a section that has a “concave shape”, or a curvature or indentation that curves inward, relative to the outer surface of the otherwise tubular structure.

[0023] Overall, the prosthetic heart valve system is designed to provide a reliable and adaptable solution for replacing malfunctioning heart valves. Its design ensures proper anchoring within the heart and adjacent vessels and structures, while its flexible components allow for easy deployment and long-term functionality.

[0024] With the prosthetic heart valve system provided herein, the objections underlying the invention are fully solved.When referring to the inflow and outflow end, generally, the direction of the blood flow through the prosthetic heart valve system is defined, i.e. , the blood enters the prosthetic heart valve system at the inflow end and is intended to leave the prosthetic heart valve system at the outflow end. Due to the large cells in the intermediate section, which are uncovered by a material (i.e., no material like a prosthesis material or valve material is covering the cells from the inside or outside), the pathway towards the openings of the left and right coronary arteries remain open, so that blood can also leave the prosthetic heartvalve system at this point, ensuring and guaranteeing the coronary blood supply. Accordingly, the valve element’s orientation can also be identified as to comprise an inflow end (i.e. , the region of the annulus section) and an outflow end, i.e. , the region of the aortic section.

[0025] With the prosthesis heart valve system placed in the heart, the stent graft component will cover the aorta ascendens, with the stent elements allowing a flexible alignment. Also, with the graft element of the stent graft component, a sealing at the stent graft ends, i.e., inflow and outflow, can be achieved by placing the stent graft component within the target vessel.

[0026] Any suitable fluid-tight or substantially fluid-tight material can be used for the graft element of the stent graft component. In a preferred embodiment, the material for the graft element is a biocompatible fabric, including but not limited to woven, knitted or otherwise fabricated material, such as polyester, such as polyethylene terephthalate, fluorinated polymers, such as polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyvinylidene fluoride, polysiloxane, including polydimethyl siloxane, polyurethanes, including polyetherurethanes, polylactide, polyglycolide and copolymers thereof. In another embodiment, material for the graft element is an animal-derived tissue, such as but not limited to porcine pericardium, bovine pericardium, dry porcine pericardium, dry bovine pericardium.

[0027] Also, materials that are not inherently biocompatible may be used when previously subjected to surface modifications in order to render the materials biocompatible.

[0028] The valve component is / is designed for anchoring in the region of the left ventricular outflow tract (LVOT), sinus of Valsalva, annulus, native valve leaflets, sino-tub- ular junction of a heart of a patient.

[0029] The designation of the valve component’s sections with “aortic” and “annulus” and with the “intermediate” row also serves to indicate the orientation of this valvecomponent, as well as to substantially designate the location of the section upon placement in the heart: The aortic section, upon placement of the prosthetic heart valve system, will be located right above / in the vicinity of the sino-tubular junction, the intermediate section will be located at / around the height of the native leaflets, sinuses of Valsalva and coronary ostia, and the annulus section will be located at / around the valve annuls and the LVOT of the heart.

[0030] The prosthetic heart valve system of the invention is generally used in the heart of a mammalian patient in need thereof, i.e., a patient suffering from a mal- or non-functioning aortic valve, and / or generally suffering from aortic valve disease, aortic stenosis, ascending aortic aneurysms, aortic insufficiency, aortic regurgitation, ascending aneurysm, bicuspid valve disease, and / or aortic dissection. The patient preferably is human.

[0031] According to one aspect, the annulus section and / or the aortic section, and / or the intermediate section comprise(s) a row of a plurality of cells, each cell of the plurality of cells being generally diamond-shaped and having four corners, respectively formed by two angularly connected struts, with a first corner pointing towards the outflow end and a second corner pointing toward the inflow end, and a third and a fourth corner pointing into the direction of the circumference c of the stent frame.

[0032] The generally diamond-shaped form of the cells provides enhanced radial strength and flexibility, allowing the system to conform to the natural shape of the aortic anatomy while minimizing stress on the stent frame.

[0033] Presently, and as generally understood, with the expression “generally diamond-shaped” when referring to the shape of a cell, it is meant that the cell has an overall shape resembling that of a diamond or rhombus, but it allows for some variation or approximation in the exact geometry. In this context, "generally" means that the shape is predominantly diamond-like, with four sides and pointed ends, but it may not conform perfectly to the strict geometrical definition of a diamond or rhombus. In other words, the diamond shape is represented by two opposing pairs of about parallel struts.

[0034] According to another aspect of the invention, the intermediate section comprises a row of cells having between 3 and 12, preferably 6 cells.

[0035] By optimizing the number of cells in the intermediate section, in particular by providing the large cells in the intermediate section, the system enhances flexibility in this region, which is essential for accommodating anatomical variations and ensuring a secure fit. In particular 6 cells in the intermediate section are preferred.

[0036] According to the invention, the large cells of the intermediate section are not covered by prosthesis material or valve elements, thus guaranteeing that the prosthetic heart valve is pervious to the coronary blood flow.

[0037] In another aspect of the invention, a row of cells in the annulus section and / or the aortic section comprises between 6 and 24 cells, preferably 9, 12 or 15 cells.

[0038] Customizing the number of cells in these sections allows for scalability of the prosthetic valve, enabling adaptation to different patient anatomies and varying degrees of dilation in the aortic annulus and aorta. A particularly preferred embodiment has 12 cells in an outermost (i.e., the last row of cells at the inflow end) row of cells of the annulus section at the inflow end, and 12 cells in the outermost (i.e. the last low of cells at the outflow end) row of cells of the aortic section at the outflow end.

[0039] The intermediate section has preferably one (1) row of cells, a cell of the row of cells of the intermediate section comprising a cell area ratio of at least from about 2: 1 , preferably 3: 1 , to about 5: 1.

[0040] According to another aspect of the invention, each cell in the row of cells in the intermediate section comprises a cell area, such, that the cell area ratio of the cell area of each cell in the row of cells in the intermediate section to a cell area of each cell in the row of cells in the aortic and annulus section is at least from about 2:1 , preferably 3: 1 , to about 5: 1. That is, according to this embodiment, each and every cell of the row ofcells of the intermediate row has a cell area that is at least two-times larger than the cell area of each cell of the aortic section and / or the annulus section.

[0041] According to a preferred embodiment, each and every cell of the row of cells of the intermediate row has a cell area that is larger than the cell area of a or any cell of the aortic section and the annulus section.

[0042] According to another preferred embodiment, each and ever cell of the row of cells of the intermediate row as the same cell area, that is at least two-times larger than the cell area of a cell of the aortic section and the annulus section. In other words, in this embodiment, each and every cell of the row of cells of the intermediate row has the same cell area, and the ratio of the cell area of a cell of the row of cells of the intermediate row to the cell area of a cell of the row of cells of the annulus section and of the aortic section is at least from about 2:1, preferably 3: 1 , to about 5: 1.

[0043] By ensuring that each of the cells in the intermediate section is larger than each of the cells in the annulus and aortic section, the handling and placement of the prosthetic heart valve system in the heart is even more facilitated, since the orientation of the intermediate section will not depend on the size of the cells to guarantee a pervious coronary flow.

[0044] Generally, preferred length dimensions - measured along the longitudinal axis of the prosthetic heart valve system - the aortic section, the intermediate row, that forms a section, and the annulus section are, e.g., from about 8 mm to14 mm (aortic section), 12 to 24 mm (intermediate section), and 6 to 12 mm (annulus section), respectively.

[0045] In a further aspect of the present invention relates to a prosthetic heart valve system comprising an outflow end and an inflow end, a stent graft component, the stent graft component being generally tubular and having a longitudinal axis, and comprising a stent element and a graft element covering the stent element, and a valve component, the valve component being generally tubular and comprising a stent frame and a valve member, the stent frame having a radially collapsed configuration and a radiallyexpanded configuration, and wherein the stent frame comprises a plurality of rows of cells, which cells are formed by struts joined to each other at intersection points, the cells being arranged adjacent to one another and extending around a circumference c of the stent frame, wherein the stent frame comprises an annulus section, an aortic section, and an intermediate section located between the annulus section and the aortic section, wherein the intermediate section is comprised of one row of cells comprising six cells, wherein the aortic section and the annulus section, in the radially expanded configuration, have a larger diameter than the intermediate section, and wherein a cell area ratio of a cell area of a cell in the row of cells in the intermediate section to a cell area of a cell in the row of cells in the annulus section and of a cell in the row of cells in the aortic section is at least from about 2:1, preferably 3.:1, to about 5:1. Further, in a refinement of this embodiment, the stent frame, in the annulus section and the aortic section, respectively, comprises two rows of cells formed by struts joined to each other at intersection points, each of which row of cells comprises twelve cells, and six singular or individual cells, each of which does not have adjacent cells in a circumferential row of cells.

[0046] According to another aspect of the invention, the annulus section comprises a crown section, the crown section being comprised of a plurality of strut-elements outwardly (with respect to the tubular configuration) and circumferentially protruding, preferably towards the sinuses of Valsalva, in the radially expanded configuration.

[0047] The crown section enhances anchoring in the annulus, the sinuses of Valsalva and / or the native leaflets by providing additional support and stabilization, which is critical for preventing migration and / or embolization of the prosthetic heart valve system after implantation.

[0048] Accordingly, with a “crown section” a plurality of circumferentially outwardly protruding struts- or wire-elements are designated, which extend away from the generally tubular body of the stent frame and are configured to engage with the surrounding anatomy, such as the annulus of the heart. The crown section also is preferably ringlike circumferentially surrounding the stent frame at the annulus section at the indicated position. This implies that all of the strut-elements are circumferentially surround the tubular stent frame along the same virtual plane.

[0049] According to an embodiment, the crown section can be formed using a shape setting tool, such, that exact or at least three strut-elements are formed by preformed protrusions of the shape setting tool.

[0050] In other words, the outwardly protruding strut-elements of the crown section are formed by angularly connected struts, creating a series of peaks, giving the crown section a wavelike or scalloped structure. In the expanded configuration, the crown section ensures optimal positioning and anchoring of the stent frame within the biological structure.

[0051] According to another aspect of the invention, a strut-element of the plurality of the strut-elements is formed of two angularly connected struts each having a first end and a second end, the first ends of the two struts being connected with one another, and the second ends of the two struts being connected, respectively, to the third and fourth corner of a cell of a row of cells of the annulus section, and / or to a second and a first strut of two non-adjacent cells of a row of cells of the annulus section, and wherein preferably the strut-element is arranged essentially parallel to the angularly connected struts forming the first corner of a cell in a row of cells. In an embodiment, the second ends of the two struts are connected with one another, such, that a closed loop or circular structure is formed.

[0052] This configuration of strut-elements resembles the formation of wings in the annulus section, which protrude outwardly from the longitudinal axis in the expanded configuration. This structure of the strut-elements ensures that the struts maintain proper alignment and tension during expansion, thereby contributing to the overall durability and positioning accuracy of the valve.

[0053] According to one embodiment, the second ends of the strut-elements are, respectively, connected, to a second strut of a first cell and a first strut of a second cell of a first row of cells of the annulus section, wherein the first cell and the second cell are not adjacent to one another in the first row of cells.

[0054] According to another aspect of the invention, the crown section has exactly three strut-elements or only every second cell in the row of cells of the annulus section comprises a strut-element. Preferably the exactly three strut-elements are circumferentially spaced at 120° in the crown section.

[0055] This selective distribution of strut-elements reduces the overall material and stiffness of the structure, allowing for better flexibility in the valve’s movement while still providing sufficient support.

[0056] In a further refinement of this embodiment, and another aspect of the invention relates to a prosthetic heart valve system comprising an outflow end and an inflow end, a stent graft component, the stent graft component being generally tubular and having a longitudinal axis, and comprising a stent element and a graft element covering the stent element, and a valve component, the valve component being generally tubular and comprising a stent frame and a valve member, the stent frame having a radially collapsed configuration and a radially expanded configuration, and wherein the stent frame comprises a plurality of rows of cells, which cells are formed by struts joined to each other at intersection points, the cells being arranged adjacent to one another and extending around a circumference c of the stent frame, wherein the stent frame comprises an annulus section, an aortic section, and an intermediate section located between the annulus section and the aortic section, wherein the intermediate section is comprised of one row of cells comprising six cells, wherein the aortic section and the annulus section, in the radially expanded configuration, have a larger diameter than the intermediate section, and wherein a cell area ratio of a cell area of a cell in the row of cells in the intermediate section to a cell area of a cell in the row of cells in the annulus section and of a cell in the row of cells in the aortic section is at least from about 2:1, preferably 3: 1 , to about 5: 1. Further, in a refinement of this embodiment, the stent frame, in the aortic section, comprises two rows of cells formed by struts joined to each other at intersection points, each of which row of cells comprises twelve cells, and six singular or individual cells, each of which does not have adjacent cells in a circumferential row of cells. Further, this embodiment comprises, as discussed above, the crown section being comprised of a plurality of strut-elements outwardly (with respect to the tubular configuration) and circumferentially protruding, with a strut-element of the plurality of the strut-elements being formed of two angularlyconnected struts each having a first end and a second end, the first ends of the two struts being connected with one another, and the second ends of the two struts being connected, respectively, to the third and fourth corner of a cell of the row of cells of the annulus section, and / or to a second and first strut of two non-adjacent cells of a first row of cells of the annulus section, and wherein preferably the strut-element is arranged essentially parallel to the angularly connected struts forming the first corner of a cell in a row of cells. In this embodiment, preferably exactly three strut-elements are provided, which preferably are circumferentially spaced at 120° in the crown section, or six strut-elements are provided at every second cell in the row of cells of the annulus section. Also, the annulus section comprises a row of cells, formed by struts joined to each other at intersection points, which row of cells comprises twelve cells, and a row of cells having six cells.

[0057] According to another aspect of the invention, the crown section is formed by strut-elements and the strut-elements outwardly protruding represent the two struts forming the first corner of a cell of a last row of cells of the annulus section, and pointing towards the outflow end, which last row of cells is directly adjacent to the row of cells of the intermediate section.

[0058] This arrangement of struts elements has the advantage that additional wings / protrusion means are not necessary, but rather the struts of a cell of a row of cells in the annulus section can be designed to protrude outwardly.

[0059] It is to be understood, and, in other words, that in this case the struts outwardly protruding represent a “free” edge or corner of a cell, which corner or edge is not connected at this corner / edge of an adjacent cell’s corner / edge. Rather, the cor- ner / edge protrudes freely and outwardly away from the longitudinal axis in the radially expanded configuration. In this embodiment, the stent provides additional radial strength at the critical interface between the annulus and intermediate row, reinforcing the structure where pressure gradients may be highest.

[0060] With the “last row” of cells of the annulus section, the row of cells is meant which is directly adjacent to the (one) row of cells of the intermediate section.

[0061] According to another aspect of the invention, each cell of the last row of cells of the annulus section comprises the strut-elements outwardly protruding.

[0062] By ensuring every cell in the final row has outwardly protruding strut- elements, the system enhances its overall radial / axial strength, ensuring a secure and stable placement in the annulus.

[0063] Accordingly, in a further refinement of this embodiment, and another aspect of the invention relates to a prosthetic heart valve system comprising an outflow end and an inflow end, a stent graft component, the stent graft component being generally tubular and having a longitudinal axis, and comprising a stent element and a graft element covering the stent element, and a valve component, the valve component being generally tubular and comprising a stent frame and a valve member, the stent frame having a radially collapsed configuration and a radially expanded configuration, and wherein the stent frame comprises a plurality of rows of cells, which cells are formed by struts joined to each other at intersection points, the cells being arranged adjacent to one another and extending around a circumference c of the stent frame, wherein the stent frame comprises an annulus section, an aortic section, and an intermediate section located between the annulus section and the aortic section, wherein the intermediate section is comprised of one row of cells comprising six cells, wherein the aortic section and the annulus section, in the radially expanded configuration, have a larger diameter than the intermediate section, and wherein a cell area ratio of a cell area of a cell in the row of cells in the intermediate section to a cell area of a cell in the row of cells in the annulus section and of a cell in the row of cells in the aortic section is at least from about 2:1, preferably 3.:1 , to about 5:1. Further, in a refinement of this embodiment, the stent frame, in the aortic section, comprises two rows of cells formed by struts joined to each other at intersection points, each of which row of cells comprises twelve cells, and six singular or individual cells, each of which does not have adjacent cells in a circumferential row of cells. Further, this embodiment comprises, as discussed above, the crown section, which crown section is formed by strut-elements and the strut-elements protrude outwardly and represent the two struts forming the first corner of a cell of a last row of cells of the annulus section and pointing towards the outflow end, which last row of cells is directly adjacent to the row of cells of the intermediate section. In this embodiment, six strut-elements are provided at everysecond cell in the last row of cells of the annulus section. Also, the annulus section comprises two rows of cells, formed by struts joined to each other at intersection points, which row of cells comprises twelve cells.

[0064] According to another aspect of the invention, in the intermediate row, between two adjacent cells of the row of cells, at least one rhomboid cell is provided, the cell area of which is smaller than the cell area of the two directly adjacent cells of the row of cells in the intermediate row and smaller than the cell area of any of the cells of row of cells in the annulus section and in the aortic section, the rhomboid cell having a first pair of edges, being opposite to one another along a first diagonal that is parallel to the longitudinal axis, and a second pair of edges, being opposite to one another along a second diagonal in the circumferential direction, wherein in the radially collapsed configuration, the length of the second diagonal is longer than the length of the second diagonal in the radially expanded configuration.

[0065] These smaller rhomboid cells enhance flexibility and help distribute stress evenly during the transition between sections, improving the valve’s ability to conform to complex geometries in the aortic root.

[0066] In particular, in the radially expressed configuration, the rhomboid cell provides “extra” or additional length required to bulge the so-called intercommissural portions of the stent frame. The “intercommissural portion” of a stent frame refers to the section of the stent frame that spans between the commissures of a valve structure / valve element of a prosthetic heart valve system. Due to the bulges, the intermediate section, in the radially expanded configuration, does not have a perfect hourglass shape; in other words, the diameter of the intermediate section is not entirely, i.e., not over the entire longitudinal length of the cells in the intermediate section, smaller than the diameters of the annulus and aortic section in the radially expanded configuration. However, the intermediate section, i.e., the intermediate row has a portion comprising a smaller diameter than the annulus and the aortic section, namely outside of the portion of the bulges caused by be rhomboid cells, and preferably in the region where the intermediate row of cells is connected to the aortic section.

[0067] In this connection, presently and as generally understood, “commissures” in heart valves are the points or regions where the leaflets (or cusps) of a valve meet and are attached to the wall of the valve. For example, in the aortic or mitral valve, commissures are the areas where the valve leaflets come together at the edges. The in- tercommissural portion, accordingly, is the part of the stent frame that connects or extends between the commissures. In valved stent frame, the intercommissural portion is often designed to provide structural support while allowing the valve leaflets to function properly. It helps maintain the geometry of the valve and contributes to its stability when implanted in the body.

[0068] The rhomboid cells, in the radially expanded configuration and placed in the heart, provide for bulges in the stent frame, which, between inflow and outflow of blood, remain fully connected with the surrounding tissue, in order to intercept the Valsalva sinuses and native leaflets. In that way, the risk of migration / embolization of the prosthetic heart valve system is mitigated and the overall placement is stabilized.

[0069] According to another aspect of the invention, in the intermediate section, between 2 and 6, preferably 3 rhomboid cells are provided. The inclusion of a specific number of rhomboid cells ensures precise control over the expansion and flexibility of the intermediate section, optimizing the fit within the aortic anatomy.

[0070] In a particularly preferred embodiment, the intermediate section / row comprises six cells, each of which have a larger cell area than all (i.e. , each) of the cells of the annulus and aortic section, and, in addition, three rhomboid cells are provided.

[0071] Accordingly, in a further refinement of this embodiment, and another aspect of the invention relates to a prosthetic heart valve system comprising an outflow end and an inflow end, a stent graft component, the stent graft component being generally tubular and having a longitudinal axis, and comprising a stent element and a graft element covering the stent element, and a valve component, the valve component being generally tubular and comprising a stent frame and a valve member, the stent frame having a radially collapsed configuration and a radially expanded configuration, and wherein the stentframe comprises a plurality of rows of cells, which cells are formed by struts joined to each other at intersection points, the cells being arranged adjacent to one another and extending around a circumference c of the stent frame, wherein the stent frame comprises an annulus section, an aortic section, and an intermediate section located between the annulus section and the aortic section, wherein the intermediate section is comprised of one row of cells comprising six cells, wherein a cell area ratio of a cell area of a cell in the row of cells in the intermediate section to a cell area of a cell in the row of cells in the annulus section and of a cell in the row of cells in the aortic section is at least from about 2:1, preferably 3.:1, to about 5:11, and wherein in the intermediate section, between two adjacent cells of the row of cells, one rhomboid cell is provided, the cell area of which is smaller than the cell area of the two adjacent cells of the row of cells in the intermediate section and smaller than the cell area of any of the cells of row of cells in the annulus section and in the aortic section, such, that six rhomboid cells are provided, each having a first pair of edges being opposite to one another along a first diagonal e parallel to the longitudinal axis L, and a second pair of edges, being opposite to one another along a second diagonal in the circumferential direction, wherein in the radially collapsed configuration, the length of the second diagonal f is longer than the length of the second diagonal in the radially expanded configuration. Further, in a refinement of this embodiment, the stent frame, in the aortic section and the annulus section, comprises two rows of cells formed by struts joined to each other at intersection points, each of which row of cells comprises twelve cells, and six singular or individual cells, each of which does not have adjacent cells in a circumferential row of cells.

[0072] According to another aspect of the invention, the annulus section and / or the aortic section each comprises between 1 and 4 row of cells.

[0073] This configuration allows for customizable valve sizing, which is critical in addressing variations in patient anatomy, particularly in cases where different aortic diameters are encountered.

[0074] According to another aspect of the invention, at the inflow end, the annulus section has a first row of cells, and wherein every second cell, at its second cornerpointing toward the inflow end, has strut-attachment-means protruding beyond the second corners of the cells of the first row of cells.

[0075] Via these strut-attachment-means, the prosthetic heart valve system can be easily loaded and temporarily fixed on a loading system of a catheter. The strut-attach- ment-means do not represent part of the cells but are separate / additional means which are attached to and extend / protrude beyond the corner of the edges, allowing them to be fixed in a catheter, thereby facilitating the loading of the system onto the catheter and holding the system in a radially compressed state.

[0076] According to an embodiment of the invention, the strut-attachment- means are comprised of a short straight single strut comprising two ends, one end being attached to the second corner of the cell(s) of the first row of cells, and one end carrying a closed or open circular / ring structure.

[0077] This embodiment has the advantage that these attachment means can be accommodated in respective recesses in the loading system, the recesses having the negative shape of these attachment means, i.e. a shape where a straight strut and / or the closed or open structure can be accommodated.

[0078] According to another aspect of the invention, the valve component comprises a collapsible and expandable valve member mounted within the stent frame at the annulus section, wherein preferably the valve component further comprises a skirt assembly mounted to the stent frame.

[0079] This collapsibility ensures ease of delivery through minimally invasive techniques, allowing for smooth navigation through the vasculature and precise positioning of the prosthetic heart valve system.

[0080] The valve element can be created from human or animal donors. They can be created, e.g., from pericardium of human or any mammal, or from native leaflets from the heart or veins, or from any other biological material suitable for the intendedpurpose. Generally speaking, such valves are also called biological or tissue valves - as contrary to mechanical valves.

[0081] Accordingly, in a preferred embodiment, the valve element is a biological valve and comprises or consists of a material that is selected from animal pericardium, in particular porcine, bovine, equine pericardium, or from native leaflets from human heart or veins.

[0082] According to another aspect of the invention, the valve component and the stent graft component are connected with one another only via the graft element, with the stent element and the stent frame not being interconnected with each other through struts.

[0083] This separation of components ensures that each part of the system can function independently, enhancing flexibility and minimizing stress on the valve, which can improve durability and reduce complications.

[0084] According to another aspect of the invention, the stent element comprises a plurality of stent springs, which stent springs are not connected via one another through struts, and which stent springs are attached, preferably sewn, at intervals, to the graft element.

[0085] By using stent springs instead of continuous interconnected struts, the design allows for greater flexibility and a more dynamic response to the natural movements of the heart, improving overall functionality.

[0086] According to another aspect of the invention, the stent springs are circumferentially undulating and forming bends, which bends are alternately oriented toward the outflow end and the inflow end, and which stent springs are aligned along the longitudinal axis of the stent graft component, such that a bend of a first stent spring, which bend is oriented toward the outflow end, is aligned with a bend of a spaced apart second stent spring also oriented towards the outflow end.

[0087] This undulating design distributes stress more evenly across the stent graft, reducing the risk of fatigue and structural failure over time.

[0088] According to another aspect of the invention, the prosthetic heart valve system is used for / in a method for anchoring to the heart of a patient, wherein the stent graft component is sized and configured for being anchored in the ascending aorta above the sino-tubular junction and distal to the aortic arch, and wherein the valve component is sized and configured for being anchored in the region of the annulus of the heart of a patient.

[0089] The sizing and configuration for specific anatomical regions ensure that the prosthesis is well-seated in both the aortic and annular regions, reducing the risk of valve migration or paravalvular leakage, thus improving patient outcomes.

[0090] Generally, while the description of the present prosthetic heart valve system is defined with regard to the position in the region of the aorta / aortic valve, the prosthetic heart valve system can also be used for any other heart valve or any other vessel, the prosthetic heart valve system is suitable for, and a person skilled in the art will recognize the dimensions of the prosthetic heart valve system in view of the respective anatomical conditions of a patient in need receiving a prosthetic heart valve system of the invention.

[0091] According to another aspect of the invention, the stent graft component and / or the valve component are provided with radiopaque markers, radiopaque sutures or reference elements.

[0092] In a preferred embodiment of the invention, the stent graft component is provided with radiopaque markers at the proximal end and distal end of the stent graft element to guarantee a proper placement to ensure the patency of the coronary and head vessel openings. The radiopaque markers at the proximal end and distal end or on the inflow and outflow end can be different.

[0093] With “proximal” and “distal” end of the stent graft element the inflow and outflow end, respectively, with regard to the stent graft component are designated. That is, the inflow end of the stent graft component represents the end connected (via the graft element) with the valve component, and the outflow end of the stent graft element also represents the outflow end of the prosthetic heart valve system.

[0094] Generally, the stent frame and / or the stent element can be made of or comprise any suitable material, including but not limited to biocompatible metals, implantable quality stainless steel wires, nickel, and titanium alloys, in particular nitinol, and biocompatible plastics attached to a graft.

[0095] In an aspect of the invention, the stent element of the stent graft component comprises or consists of individual stent rings three-dimensionally shaped, or a woven or braided stent frame comprising interwoven or braided stent elements. In another aspect, the stent frame of the valve component is a laser-cut stent frame.

[0096] In a further aspect, the stent frame and / or stent element is either self-expandable or balloon-expandable, which allows for radial force fixation within the intended anatomical landing zones, e.g., aorta ascendens, left ventricular outflow tract (LVOT), s / - nus Valsalva, sino-tubular junction and / or annulus.

[0097] As mentioned above, the present invention also relates to the prosthetic heart valve system as described above for anchoring into / to the cardiovascular system of a patient, wherein the stent graft component is sized and configured for being anchored in a target artery, preferably in the ascending aorta above the sino-tubular junction, and wherein the valve component is sized and configured for being anchored in the target valve complex of a patient, preferably in the region of the annulus, sinuses of Valsalva, coronary ostia, native leaflets and cusps and sino-tubular junction of the aortic complex.

[0098] The prosthetic heart valve system of the present invention can also be used in a method for treating a disease in a patient in need thereof, which disease is selected from repair of aortic valve disease, aortic stenosis, ascending aortic aneurysms,aortic insufficiency, aortic regurgitation, ascending aneurysm, bicuspid valve disease, and / or aortic dissections.

[0099] According to this method or use, a prosthetic heart valve system of the invention is selected for the patient in particular depending on the structural conditions of the heart, and the selected prosthetic heart valve system is loaded onto a delivery catheter, and the delivery catheter is introduced into the patient and advanced to the heart, and subsequently released, such, that the stent graft component is placed in the intended anatomical landing zones, such as aorta ascendens, and the valve component is placed in the intended anatomical landing zones, such as the left ventricular outflow tract (LVOT), sinus Valsalva, sino-tubular junction and / or annulus of the heart of the patient.

[0100] The system according to the invention can be either surgically implanted or delivered by transcatheter methods. In the latter case, i.e. with a transcatheter method, the system according to the invention is loaded onto a suitable deployment catheter, there being compressed by a retractable sheath or tube. The deployment catheter is inserted into the heart of a patient whose aortic valve needs replacement or support.

[0101] The deployment catheter having the system according to the invention loaded thereon in a compressed state, can be advanced, e.g., transapically (i.e., through the apex of the heart), into the heart’s left ventricle; using imaging guidance (typically fluoroscopy and echocardiography), the catheter is directed across the aortic valve into the diseased valve site. Once in position, the prosthetic heart valve system is deployed inside the patient’s existing, diseased aortic valve by retracting the sheath and allowing the valve to expand to its full size, positioning itself within the native valve annulus.

[0102] Alternatively, when using TAVR, the prosthetic heart valve system of the invention can be introduced transfemoral through the femoral artery.

[0103] In both routes, correct placement can be monitored via the visualization elements, e.g., radiopaque markers, radiopaque sutures, radiopaque components of the prosthetic heart valve system and / or delivery system.

[0104] Upon correct placement, the sheath or the otherwise compressing means is retracted to stepwise release the system according to the invention, upon which action the stent members of the system, i.e. the stent frame and the stent element can expand and fixate the prosthetic heart valve system to the surrounding anatomy, e.g., vessels and / or the heart.

[0105] The one or more valve mounted on the prosthetic heart valve system can operate as soon as the compressing means are retracted.

[0106] The prosthetic heart valve system of the invention has the advantage that the system can be radially compressed and retracted again, in case the placement needs to be corrected.

[0107] Further advantages and features of the invention are set forth in the following description and in the attached figures.

[0108] It will be understood that the aforementioned features and the features still to be explained below can be used not only in the respectively specified combination but also in other combinations or on their own, without departing from the scope of the present invention.BRIEF DESCRIPTION OF THE DRAWINGS

[0109] The aforementioned features of the invention and the features still to be explained below are shown in the figures, in which:

[0110] Fig. 1 shows a schematic drawing of a human heart in A; B shows an isolated depiction of the anatomic segments of the thoracic aorta; and C shows a schematic drawing of an exemplary embodiment of the prosthetic heart valve system of the invention implanted in the heart;

[0111] Fig. 2 shows a schematic drawing of a first embodiment of the prosthetic heart valve system of the invention; with the stent frame of the valve component displayed rolled-up in A, and tubular shaped and in radially compressed configuration in B; the radially expanded configuration is shown in C, and the assembled prosthetic heart valve system is shown in D;

[0112] Fig. 3 shows a schematic drawing of a second embodiment of the stent frame of the prosthetic heart valve system of the invention, with the stent frame of the valve component displayed rolled-up in A, which, on the right hand side also shows an enlarged portion of the stent frame; the radially expanded configuration is shown in B; the isolated stent frame of this embodiment is shown, in the radially expanded configuration, placed at the level of the ventricular outflow tract (LVOT), sinus of Valsalva, annulus, native valve leaflets, sino-tubular junction of a heart of a patient in C;

[0113] Fig. 4 shows a third embodiment of the stent frame of the prosthetic heart valve system of the invention, the stent frame shown in radially expanded configuration;

[0114] Fig. 5 shows a fourth embodiment of the prosthetic heart valve system of the invention, with the stent frame of the valve component displayed rolled-up in A, in a radially expanded configuration is shown in B; C shows a schematic illustration of the form of the rhomboid cell of the fourth embodiment upon radial compression (left), radial expansion (middle) and again compression (right); and D shows an assembled prosthetic heart valve system using the stent frame of the fourth embodiment, and E shows an enlarged portion of the system shown in D; and

[0115] Fig. 6 shows a schematic drawing of a fifth embodiment of the stent frame of the prosthetic heart valve system of the invention, with the stent frame of the valve component displayed in the radially expanded configuration shown in A and rotated around the longitudinal axis in B; and with the completely assembled valve component in C; D and E show the forming of the stent frame of this embodiment, using a shape settingtool, and F a side view of the shape setting tool with focus on the forming of one exemplary strut-element.DETAILLED DESCRIPTION OF PREFERRED EMBODIMENTS

[0116] In Fig. 1A, a human heart 150 is depicted, having a right atrium 154, a right ventricle 155, a left atrium 156 and a left ventricle 157. Also depicted in Fig. 1 is a portion of the superior vena cava 152, entering the heart 150 via the right atrium 154, and a portion of the inferior vena cava 153. Arrows 170 and 171 indicate the physiological direction of blood flow.

[0117] In more detail, the superior vena cava 152 returns the blood from the upper half of the body and opens into the upper and back part of the right atrium 154, the direction of its orifice 152a being downward and forward. Its orifice 152a has no valve.

[0118] The inferior vena cava 153, which has a larger diameter than the superior vena cava 152, returns the blood from the lower half of the body, and opens into the lowest part of the right atrium 154, its orifice 153a being directed upward and backward, and guarded by a rudimentary valve, the valve of the inferior vena cava (Eustachian valve, not shown).

[0119] The right ventricle 155 has a triangular in form and extends from the right atrium 154 to near the apex 159 of the heart 150.

[0120] The right atrioventricular orifice (not depicted in Fig. 1) is the large oval aperture of communication between the right atrium 154 and ventricle 155, and is guarded by the tricuspid valve 160.

[0121] The opening 161 of the pulmonary artery 162 is circular in form and is placed above and to the left of the atrioventricular opening; it is guarded by the pulmonary valves 163.

[0122] The left atrium 156 is smaller than the right atrium 154. The left ventricle 157 is longer and more conical in shape than the right ventricle 155. The left atrioventricular opening (mitral orifice, not depicted in fig. 1) is placed to the left of the aortic orifice 165, and is guarded by the bicuspid or mitral valve 166.

[0123] The aortic opening 165 is a circular aperture, in front and to the right of the atrioventricular opening, and its orifice is guarded by the aortic valve 167. Reference number 168 in Fig. 1A generally designates the aorta.

[0124] Fig. 1B shows, in an enlarged view as compared to Fig. 1A, the anatomic segments of the thoracic aorta 168a, with the aortic root designated with 180, the sino-tubular junction schematically indicated with 181 , and the ascending thoracic aorta (aorta ascendens) with 182. The aorta ascendens 182 passes into the aortic arch 183, with the brachiocephalic trunk 184, the left common carotid artery 185 and the left subclavian artery 186 branching off in the aortic arch 183; the descending aorta is designated with 187. In the aortic root 180, the coronary artery 188a and 188b are branching off. In the aortic root 180, the sinuses of Valsalva is designated with 189, and, again the aortic valve 167 is shown.

[0125] With the system according to the invention, aortic valve diseases as mentioned above can be treated, and placement of an exemplary embodiment of the prosthetic heart valve system 10 according to the invention is depicted in the attached fig. 1C. Generally, the prosthetic heart valve system 10 comprises a stent graft component 12 and a valve component 16. As can be seen in this figure, with reference to the feature designated in Fig. 2, in the configuration, where the prosthetic heart valve system 10 is radially expanded in the heart of a patient to be treated, the stent graft component 12 is placed and anchored in the aorta ascendens 182, and the valve component 16 is anchored in the region of the ventricular outflow tract (LVOT), sinus of Valsalva 189, annulus, native valve leaflets, sino-tubular junction 181 of a heart of a patient.

[0126] As mentioned above, Fig. 2 shows a schematic drawing of a first embodiment of the prosthetic heart valve system of the invention, wherein Fig. 2A shows thestent frame 17 of the valve component 16 of this embodiment rolled-up; Fig. 2B displays the stent frame 17 in a tubular shape and in a radially compressed configuration. The radially expanded configuration is shown in Fig. 2C, and the assembled prosthetic heart valve system 10, comprising the stent graft component 12 and the valve component 16 is shown in Fig. 2D.

[0127] As can be seen in Fig. 2, the stent frame 17 comprises an annular section 22, an aortic section 23, and an intermediate section 24 between the annulus section 22 and the aortic section 23. The annulus section 22 represents the region at the inflow end 11a of the prosthetic heart valve system 10.

[0128] The stent frame 17 is comprised of a metal frame, and can be, e.g., selfexpanding, when using, e.g., Nitinol as material. The stent frame can be laser-cut.

[0129] As can be seen in Fig. 2, the annulus section 22 comprises cells 30, which cells 30 represent individual geometric openings or patterns formed by the interconnecting struts (thin, supporting bars) 30a, 30b, 30c, 30d, that make up the stent frame’s 17 structure. These cells 30 have a generally rhomboid, in this case diamond-shaped form. The cells 30 collectively form a lattice-like framework that can expand or collapse as the stent changes configuration from the collapsed to the expanded state. As such, the cells 30 are defined by the points where the struts 30a, 30b, 30c, 30d intersect, which are designated as intersection points or corners c1 , c2, c3, and c4, respectively. As can be taken from Fig. 2C, the struts 30a and 30b intersect at corner c1 , and struts 30c and strut 30d intersect at corner c2. Corner c1 and corner c2 are, respectively, pointing along the longitudinal axis L of the prosthetic heart valve system, with the corner c1 pointing towards the outflow end 11b, and corner c2 pointing towards the inflow end 11a. Further, the intersecting struts 30b and 30d form a corner c4, and intersection struts 30a and 30c form corner c3, which point along the circumferential direction c. The cells 30 of the annulus section 22 are arranged in a row 19a of cells, with the cells 30 being adjacent to one another in the circumferential direction.

[0130] In the shown embodiment, the annulus section comprises two rows 19a of cells, a first row of cells 19a’, which is the first row of cells 19a’ at the inflow end 11a of the stent frame 17 (which represents the inflow end 11a of the prosthetic heart valve system 10), a second row of cells 19a” adjacent to the first row of cells 19a’, both rows of which comprise, respectively, in the embodiment shown, twelve cells 30. Each two corners, the c1 corner of a first cell 30’ and the c1 corner of a second cell 30” of the second row of cells 19a”, which second cell 30” is adjacent to the first cell 30’, form, together with the c4 corner of the first cell 30’ - which is also the c3 corner of the second cell 30”, a “singular” or individual cell 30s. A cell 30s does not have (directly) adjacent cells in a circumferential row of cells. In the embodiment shown in Fig. 2c, the annulus section comprises six “singular” cells 30s. The c1 corner of this cell 30s represents the intersection point of two cells 50 of the intermediate section 24.

[0131] The aortic section 23 of the stent frame 17 also comprises cells, which are designated with the reference number 40. Also, the cells 40 of the aortic section represent individual geometric openings or patterns formed by the interconnecting struts (thin, supporting bars) 40a, 40b, 40c, 40d. Also, these cells 40 have a generally rhomboid, in this case diamond-shaped form. As the cells 30 of the annulus section, the cells 40 are defined by the points where the struts 40a, 40b, 40c, 40d intersect, which are designated as intersection points or corners c1, c2, c3, and c4, respectively. As can be taken from Fig. 2, the struts 40a and 40b intersect at corner c1 , and struts 40c and strut 40d intersect at corner c2. Corner c1 and corner c2 are, respectively, pointing along the longitudinal axis L of the prosthetic heart valve system, with the corner c1 pointing towards the outflow end 11b, and corner c2 pointing towards the inflow end 11a. Further, the intersecting struts 40b and 40d form a corner c4, and intersection struts 40a and 40c form corner c3, which point along the circumferential direction c. The cells 40 of the aortic section 23 are arranged in a row 19c of cells, with the cells 40 being adjacent to one another in the circumferential direction.

[0132] In the shown embodiment, the aortic section comprises two rows 19c of cells, a first row of cells 19c’, which is arranged at / represents the last row at the outflow end of the stent frame 17, and a second row of cells 19c” adjacent to the first row of cells 19c’, both rows of which comprise, respectively, in the embodiment shown, twelve cells40. Each two corners, the c2 corner of a first cell 40’ and the c2 corner of a second cell 40” of the second row of cells 19a”, which second cell 40” is adjacent to the first cell 40’, form, together with the c4 corner of the first cell 40’ - which is also the c3 corner of the second cell 40”, a “singular” cell 40s. A cell 40s does not have adjacent cells in a circumferential row of cells, i.e. does not have adjacent cells left and right with respect to the circumferential direction. In the embodiment shown in Fig. 2, the aortic section comprises six “singular” cells 40s. The c2 corner of this cell 40s represents the intersection point of two cells 50 of the intermediate section 24.

[0133] Fig. 2 also shows that the intermediate section 24 of the stent frame 17 comprises, i.e., represents one row 19b of cells, which row 19b comprises cells 50. The cells 50 have a cell surface area that is at least two-times larger than each of the cells 30, 40 of the annulus section 22 and aortic section 23. In the embodiment shown in fig. 2, the intermediate row of cells (i.e. the intermediate section 24) comprises six cells 50, all of which have a have a cell surface area that is at least two-times larger than each of the cells 30.

[0134] A cell 50 of the intermediate row 19b is formed by struts 50a, 50b, 50c, and 50d. Also, these cells 50 have a generally rhomboid, in this case diamond-shaped form. The struts 50a, 50b, 50c, and 50d interest at corners c1, c2, c3, and c4, respectively. As can be taken from Fig. 2, the struts 50a and 50b intersect at corner c1, and struts 50c and strut 50d intersect at corner c2. Corner c1 and corner c2 are, respectively, pointing along the longitudinal axis L of the prosthetic heart valve system, with the corner c1 pointing towards the outflow end 11b, and corner c2 pointing towards the inflow end 11a. Further, the intersecting struts 50b and 50d form a corner c4, and intersection struts 50a and 50c form corner c3, which point along the circumferential direction c. The cells 50 of the intermediate row (section) 23 are arranged in a row 19b of cells, with cells 50 being adjacent to one another in the circumferential direction.

[0135] Fig. 2D shows the assembled prosthetic heart valve system 10, comprising the stent frame 17 as detailed in Figs. 2A, 2B and 2C. As can be taken from Fig. 2D, attached to the stent frame 17 is a valve member 18, which is attached within the stent frame 17, such, that the annulus section 22 of the stent frame 17 is at least partly coveredfrom the inside with the valve member 18. Fig. 2 also shows that the stent graft component 12 and the valve component 16 are attached to one another via a graft element 14. The graft element 14 is an element of the stent graft component 12 and is attached to stent springs 13; as can be seen in Fig. 2D, the stent springs are circumferentially meandering, individual stent springs, which are arranged and attached to the graft element 14 in certain distances from one another. In the shown exemplary embodiment, the stent graft component 12 comprises four stent springs 13, i.e. , a first stent spring 13’, a second stent spring 13”, a third stent spring, 13”’, and a fourth stent spring 13’”. The stent springs 13’, 13”, 13’”, 13”” represent the plurality of stent springs 13, and are, according to an embodiment of the invention, not connected via one another through struts, and which stent springs 13’, 13”, 13’”, 13”” are attached, preferably sewn, at intervals, to the graft element 14 .

[0136] As can also be seen in Fig. 2D, the stent springs 13’, 13”, 13’”, 13”” are circumferentially undulating and form bends, which bends are alternately oriented toward an outflow end 11b and the inflow end 11a of the prosthetic heart valve system 10. Further, the stent springs 13’, 13”, 13’”, 13”” are aligned along the longitudinal axis L of the prosthetic heart valve system 10, and, thus, also of the stent graft component, such that a bend of a first stent spring 13’, which bend is oriented toward the outflow end 11b, is aligned with a bend of a spaced apart second stent spring 13” also oriented towards the outflow end 11b.

[0137] Also, the valve component 16 is attached to the graft element 14 of the stent graft component 12 via the first row of cells 19c’ of the aortic section 23, such, that the first row of cells 19c’ are spaced at a certain interval from the stent spring 13”” arranged nearer to the valve component 16 than the other stent springs 13’, 13”, 13’”.

[0138] As can be seen in Fig. 2D, the intermediate section 24, represented by the intermediate row 19b is free from a material of the graft element 14, as well as free from material of the valve member 18.

[0139] Fig. 2D also shows the configuration of the stent frame 17, where the diameters d1, d3 of the annulus and aortic section 22, 23 are larger than the diameter d3 of the intermediate section 24.

[0140] Also shown in Fig. 2 are strut-attachment-means 60, which protrude beyond the second corners c2 of the cells 30 of the first row of cells 19a’.

[0141] Via these strut-attachment-means 60, the prosthetic heart valve system 10 can be easily loaded and temporarily fixed on a loading system of a catheter (not shown). The strut-attachment-means 60 do not represent part of the cells 30 of the first row of cells (19a’) but are separate / additional means which are attached / fixed to and ex- tend / protrude beyond the corner c2. Via these strut-attachment-means 60, the prosthetic heart valve system 10 can be loaded and fixed in / onto loading system of a catheter.

[0142] In the shown embodiment, the strut-attachment-means 60 are comprised of a short straight single strut 61 comprising two ends, a first end 61a and a second end 61b, the first end 61a end being attached to the second corner c2 of the cells 30 of the first row of cells 19a’, and the second end 61b carrying a closed or open circular or ring structure 62.

[0143] Fig. 3 shows another, i.e. , second embodiment of the stent frame 17 of the valve component 16. As can be seen, in Fig. 3A shows a schematic drawing of the stent frame 17 of the valve component 16, displayed rolled-up (left); on the right hand side of Fig. 3A there is shown an enlarged portion of the stent frame 17 as displayed on the left hand side. The radially expanded configuration of this embodiment of the stent frame 17 is shown in Fig. 3B, with the circumference indicated with the dotted arrow “c”. Fig. 3C shows the isolated stent frame of this embodiment, in the radially expanded configuration, placed at the level of the ventricular outflow tract (LVOT), sinus of Valsalva, annulus, native valve leaflets, sino-tubular junction of a heart of a patient, illustrating the general placement of this element in the heart, without showing the other elements of the assembled prosthetic heart valve element system of the invention.

[0144] The stent frame 17 of this embodiment is similar to and comprises the same elements as the stent frame of the embodiment shown in Fig. 2, however, with the exception that the stent frame 17 of the embodiment shown in Fig. 3 comprises a crown section 26. The crown section 26, in the embodiment shown in Fig. 3, is comprised of a plurality of strut-elements 31 outwardly and circumferentially protruding in the radially expanded configuration, preferably towards the sinuses of Valsalva in the radially expanded configuration.

[0145] As can be seen in Fig. 3B, the strut-elements 31 are arranged circumferentially at the same level - or virtual plane - with respect to the circumference c of the tubular stent frame 17.

[0146] The annulus section 22 of the stent frame 17 of the embodiment shown in Fig. 3B has a first row of cells 19a’, with is directly located at the inflow end 11a and which comprises twelve cells 30, and an adjacent second row of cells 19a” comprising six cells. Into the cells 30 of the second row of cells 19a”, in the radially collapsed configuration, the strut-elements 31 are partly protruding, being arranged at the stent frame 17 as follows:

[0147] A strut-element 31 of the plurality of the strut-elements 31 is formed of two angularly connected struts 31a, 31b, each having a first end 31a’, 31b’ and a second end 31a”, 31b”, the struts being connected with one another via the first ends 31a’, 31b’, and the second ends 31a” and 31b” being connected, respectively, essentially to / in the region of the third and fourth corner c3, c4, in the case of a first strut-element 31-1 , or to a second strut 30b and first strut 30a of two non-adjacent cells 30-1 and 30-2 of the first row 19a’ of cells of the annulus section 22, in the case of a second strut-element 31-2. As can be seen from Fig. 3B, the strut-elements 31 are arranged essentially parallel to the angularly connected struts forming the first corner c1 of a cell 30 in the row of cells 19a’.

[0148] Via this configuration of strut-elements 31 , the strut-elements represent or form “wing elements” in the annulus section 22, which protrude outwardly from the longitudinal axis in the expanded configuration. This structure of the strut-elements 31 (as thecrown section 26) contributes to the overall durability and positioning accuracy of the replacement valve.

[0149] Further, Fig. 3B shows that only every second cell 30 in the row of cells 19a’ of the annulus section 22 comprises a strut-element 31.

[0150] Fig. 3C shows the location of the stent frame 17 (for illustrative purposes shown without the valve member 18, and without the stent graft component 12) in the heart of a patient: The stent frame 17 of the valve component 16 is placed at the level of the left ventricular outflow tract (LVOT), sinus Valsalva, sino-tubular junction and / or annulus of the heart of the patient.

[0151] The assembled prosthetic heart valve system comprising the stent frame 17 of this embodiment is not shown. However, the same valve member 18 and the same stent graft component 12 shown for Fig. 2, or any other configuration of the valve member 18 / stent graft component 21 according to the invention, can be used with the stent frame 17 / valve component 16 of the embodiment shown in Fig. 2.

[0152] Fig. 4 shows another, i.e. third, embodiment of a stent frame 17 for the valve component 16 of the prosthetic heart valve system 10 of the invention, in a radially expanded configuration. As can be seen, in this embodiment the annulus section 22 of the stent frame 17 comprises two rows of cells 19a, a first row of cells 19a’ and a second row of cells 19a”.

[0153] The general design of the cells 30, 40, 50 resembles the design of the cells of the alternative stent frames shown in figs. 2 and 3, and the same reference numbers are used to designate the same features, where applicable.

[0154] The stent frame in Fig. 4 also comprises a crown section 26, with strutelements 27 outwardly and circumferentially protruding. Also with this embodiment, the outwardly protruding strut-elements 27 of the crown section 26 are formed by angularlyconnected struts 30a, 30b, creating a series of peaks, giving the crown section 26 a wavelike or scalloped structure.

[0155] In this embodiment shown in Fig. 4, the two struts 30a, 30b form the first corner c1 of a cell 30 of the second row of cells 19a”. The two struts 30a, 30b are angularly connected to form corner c1, protrude outwardly, such that the corner c1 points towards the outflow end direction of the system. In this embodiment, also the strut-elements 27 of the crown section 26 point / are guided into the area of an adjacent cell 50 of the intermediate section 24, however, without affecting the size of the cell area of cell 50 in the expanded configuration.

[0156] This arrangement of strut-elements 27 has the advantage that additional wings / protrusion means are not necessary, but rather the struts 30a, 30b of a cell 30 of a row of cells 19a” in the annulus section 22 can be designed to protrude outwardly.

[0157] Also, in other words, in this embodiment, the strut-elements 27 outwardly protruding represent a “free” edge or corner c1 of a cell 30, which corner c1 is not connected to an adjacent cell’s corner / edge. Rather, the corner c1 protrudes freely and outwardly away from the longitudinal axis L in the radially expanded configuration.

[0158] For this embodiment of the stent frame 17, as shown in fig. 4, also a valve member 18 and the stent graft component 12 as shown and described for the embodiment depicted in Fig. 2 can be employed. The assembled prosthetic heart valve system comprising this stent frame 10 of Fig. 4 is not shown.

[0159] Fig. 5 shows a fourth embodiment of the prosthetic heart valve system of the invention, with the stent frame 17 of the valve component 16 displayed rolled-up in A, and in a radially expanded configuration is shown in B; C shows a schematic illustration of the form of a rhomboid cell 52 of the fourth embodiment upon radial compression (left), radial expansion (middle) and again compression (right); and D shows an assembled prosthetic heart valve system using the stent frame of the fourth embodiment, and E shows an enlarged portion of the system 10 shown in fig. 5D.

[0160] The general design of the cells 30, 40, 50 resembles the design of the cells of the alternative stent frames shown in Figs. 2, 3, and 4, and the same reference numbers are used to designate the same features, where applicable.

[0161] As mentioned above, Fig. 5 shows a fourth embodiment of the stent frame 17 of a valve component 16 of a prosthetic heart valve system 10 of the invention. Fig. 5A shows the stent frame 17 of the valve component 16 rolled-up, and Fig. 5B shows the stent frame 17 in a radially expanded configuration; the elements of the valve member 18 are, for a better illustrative purpose, not shown in Figs. 5B and 5B.

[0162] As can be seen in Fig. 5A, and 5B, in the intermediate section 24, or rather in the intermediate row 19b, between two adjacent cells 50’, 50” of the row of cells 19b, which have a cell area that is at least two-times larger than the cell area of a cell of the annulus and aortic section 22, 23, at least one rhomboid cell 52 is provided. As can be seen in Fig. 5A and Fig. 5B, the cell area of the rhomboid cell 52 is smaller than the cell area of the two adjacent cells 50’, 50” of the row 19b of cells in the intermediate section 24 and smaller than the cell area of any of the cells 30, 40 of row of cells 19a, 19c, in the annulus section 22 and in the aortic section 23.

[0163] The rhomboid cell 52 is provided between every second cell 50. Accordingly, since the row of cells 19b of the intermediate section 24 comprises six cells 50, the number of rhomboid cells 52 in the row of cells 19b is six.

[0164] As can be seen, e.g., in Fig. 5C, a rhomboid cell 52 has a first pair of edges 52a, 52b, which are opposite to one another along a first diagonal “e” that is parallel to the longitudinal axis L, and a second pair of edges 52c, 52d, that is opposite to one another along a second diagonal “f” in the circumferential direction.

[0165] The diagram shown in Fig. 5C is a schematic illustration of the form of a rhomboid cell 52 upon radial compression (left), radial expansion (middle) and again compression (right). The movement or transition into the respective configurations is indicated with arrows. As can be seen, in the radially collapsed configuration, the length of thesecond diagonal f is longer than the length of the second diagonal f in the radially expanded configuration. Accordingly, via these rhomboid cells, an additional length of the stent frame 17 in the intermediate section 24 in the expanded configuration is provided, which allows the formation of bulges B in the expanded configuration at the positions of the rhomboid cells, as it is shown in Figs. 5B, 5B, and 5E. As discussed above, the bulges B in the stent frame 17 remain, between inflow and outflow of blood, fully connected with the surrounding tissue, in order to intercept the Valsalva sinuses and native leaflets.

[0166] Figs 5D and 5E show an assembled prosthetic heart valve system 10, using the stent frame of the fourth embodiment shown in Fig. 5A, 5B, wherein the stent graft component 12 differs from the stent graft component 12 shown in Fig. 2D. Fig. 5E shows an enlarged portion of the system 10 shown in Fig. 5D.

[0167] As can be seen in Figs. 5D and 5E, the valve component comprises the stent frame 17 described and shown in Fig. 5A, 5B, comprising the rhomboid cells 52 between every second cell 50 if the intermediate row 19b / intermediate section 24, as well as a valve member 18 attached within thereto.

[0168] In the system 10 shown in fig. 5D, the stent graft component 12 comprises three stent springs 13’, 13”, 13”’, successively arranged and attached to the graft element 14 along the longitudinal axis L, at certain intervals, such, that the stent springs 13’, 13”, 13’” are not connected with one another via struts and do not touch each other otherwise. Also, the stent springs 13’, 13”, 13’” are circumferentially undulating and form bends, which bends are alternately oriented toward the outflow end 11b and the inflow end 11a. Further, the stent springs 13’, 13”, 13’” are aligned along the longitudinal axis L of the stent graft component 12, such, that a bend of a first stent spring 13’, which bend is oriented toward the outflow end 11b, is aligned with a bend of a spaced apart second stent spring 13” also oriented towards the outflow end 11b.

[0169] The stent graft component 12 further comprises a first terminal stent spring 13a and a second terminal stent spring 13b, which are located and attached to / at the outflow end 11b of the prosthetic heart valve system 10.

[0170] In the embodiment shown in Fig. 5D, the two stent springs 13a and 13b are attached to the graft element 14, such, that a bend of the first stent spring 13a pointing towards the outflow end 11b lies opposite to a bend of the second stent spring 13b pointing towards the inflow end 11a. Via this configuration, a stable and strong outflow end for positioning the aorta can be achieved in the expanded configuration.

[0171] Fig. 5B again shows, in an enlarged view, the portion of the system 10 where the rhomboid cells 52 effect the bulges B bulge in the stent frame 17. Due to the bulges B, the intermediate section 24, in the radially expanded configuration, does not have a perfect hourglass shape; in other words, the diameter d2 of the intermediate section is not entirely, i.e. , not over the entire longitudinal length of the cells 50 in the intermediate section 24, smaller than the diameters d1 , d3 of the annulus 22 and aortic 23 section in the radially expanded configuration. However, the intermediate section 24, i.e., the intermediate row of cells 19b, has a portion P2 comprising a smaller diameter d2 than the annulus 22 and the aortic 23 section, namely outside of the portion P1 of the bulges caused by be rhomboid cells 52, and, in other words, in the region where the intermediate row of cells 19b is connected to the aortic section’s 23 row of cells 19c, as can be seen in Fig. 5D.

[0172] It is to be understood, that the stent graft components 12 shown in Fig. 5D and 2D can be used interchangeably, and each of which can be used with any of the stent frames 17 of the valve components shown in Figs. 2 to 6.

[0173] Fig. 6 shows a schematic drawing of a fifth embodiment of the stent frame 17 of the prosthetic heart valve system of the invention, wherein Figs. 6A and 6B show the stent frame 17 of the valve component 16 displayed in the radially expanded configuration shown. The valve component 16 comprising a valve member 18 and a skirt assembly 68, is shown in Fig. 6C. Furter, Fig. 6D shows stent frame 17 formed by a shape setting tool 70, and Fig. 6E the shape-setting tool 70, in a side view displaying protruding means 71 forming the angle of an exemplary protruding strut-elements 31.

[0174] The stent frame 17 of the fifth embodiment resembles the stent frame 17 shown in Fig. 3 (second embodiment), and, accordingly, also comprises a crown section 26. The crown section 26, in the embodiment shown in Fig. 6, is comprised of a plurality of strut-elements 31 outwardly and circumferentially protruding in the radially expanded configuration, preferably towards the sinuses of Valsalva in the radially expanded configuration. The annulus section 22 of the stent frame 17 of the embodiment shown in Fig. 6 has a first row of cells 19a’, with is directly located at the inflow end 11a and which comprises twelve cells 30, and an adjacent second row of cells 19a” comprising six cells. In the expanded configuration shown in Fig. 6, from the cells 30 of the second row of cells 19a”, exactly three strut-elements 31 are protruding, being arranged at the stent frame 17 as follows:

[0175] A strut-element 31 of the plurality of the strut-elements 31 is formed of two angularly connected struts 31a, 31b, each having a first end 31a’, 31b’ and a second end 31a”, 31b”, the struts being connected with one another via the first ends 31a’, 31b’, and the second ends 31a” and 31b” being connected, respectively, to a second strut 30b of a first cell 30-1 and a first strut 30a of a second cell 30-2 of the first row 19a’ of cells of the annulus section 22. The first cell 30-1 and the second cell 30-2 are not adjacent to one another, which means, that another cell 30-3 is located in between and is adjacent to the first and second cell 30-1, 30-2. As can be seen from Fig. 3B, the strut-elements 31 are arranged essentially parallel to the angularly connected struts forming the first corner c1 of a cell 30 in the row of cells 19a’.

[0176] Via this configuration of strut-elements 31 , the strut-elements 31 represent or form “wing elements” in the annulus section 22, which protrude outwardly from the longitudinal axis in the expanded configuration. This structure of the strut-elements 31 (as the crown section 26) contributes to the overall durability and positioning accuracy of the replacement valve. As can be seen in Fig. 6, the crown section 26 has exactly three strutelements 31 , which are circumferentially spaced at 120° in the crown section 26 of the stent frame.

[0177] Fig. 6C show the assembled valve component 16 of the fifth embodiment, comprising the stent frame 17 and the valve member 18 mounted inside the tubularvalve component 16 / stent frame 17, as well as a skirt assembly 68, mounted outside the stent frame 17.

[0178] Figs. 6D to 6F illustrate the formation of an exemplary protruding strut element 31 using a shape-setting tool 70. The shape-setting tool 70 is a molding structure having, in essence, an hourglass-like configuration and comprising integrally formed protrusions 72 (three in the illustrated example) that extend outwardly from an outer surface of a main body 73 of the tool 70.

[0179] As exemplarily shown in Fig. 6F for the formation of one strut element 31 , the protrusion 72 comprises an upper surface 72a, which is substantially orthogonal to the longitudinal axis of the prosthetic heart valve system 10, and a lower surface 72b, which is inclined toward the outflow end 11b at an angle a. The angle a is between 25° and 30°, preferably about 27°, measured from a virtual line intersecting the point where the protrusion transitions, at the lower surface 72b, into the outer surface of the main body 73, orthogonal to the longitudinal axis of the prosthetic heart valve system 10. The protrusion 72 further includes a side surface 72c connecting the upper and lower surfaces 72a and 72b. The side surface 72c is also inclined such that an inner angle between the upper surface 72a and the side surface 72c is between 60° and 80°, preferably about 75°.

[0180] Accordingly, the protrusion may generally be described as having the shape of a short closed tubular or cylindrical body, the free end or side surface of which is generated by an inclined cut.

[0181] For forming the protruding strut elements 31 or 27, the stent frame 17, preferably made of a shape-memory material, is placed on the shape-setting tool 70 so that the strut elements 31, 27 are set at predetermined angles during the shape-setting process.

[0182] As shown in Fig. 6, the strut elements 31 are thereby flared from the stent frame in the inflow direction, e.g., at approximately 12 mm, and are circumferentially spaced at 120° intervals.

Claims

CLAIMS1. Prosthetic heart valve system (10) comprising an outflow end (11b) and an inflow end (11a), a valve component (16), the valve component (16) being generally tubular and comprising a stent frame (17) and a valve member (18), the stent frame (17) having a radially collapsed configuration and a radially expanded configuration, and wherein the stent frame (17) comprises a plurality of rows (19a, 19b, 19c) of cells (30; 40; 50), which cells (30; 40; 50) are formed by struts (30a, 30b, 30c, 30d; 40a, 40b, 40c, 40d; 50a, 50b, 50c, 50d) joined to each other at intersection points, the cells (30; 40; 50) being arranged adjacent to one another and extending around a circumference c of the stent frame (17), and optionally a stent graft component (12), the stent graft component (12) being generally tubular and having a longitudinal axis, and comprising a stent element (13) and a graft element (14) covering the stent element (13); wherein the stent frame (17) comprises an annulus section (22), an aortic section (23), and an intermediate section (24) located between the annulus section (22) and the aortic section (23), wherein the intermediate section (24) is comprised of one row of cells (50), and wherein, in the radially expanded configuration, a cell area ratio of a cell area of a cell (50) in the row (19b) of cells in the intermediate section (24) to a cell area of a cell (30) in the row (19a) of cells in the annulus section (22) and / or of a cell (40) in the row (19c) of cells in the aortic section (23) is at least from about 2: 1 , preferably 3: 1 , to about 5:1.

2. The prosthetic heart valve system (10) of claim 1 , wherein the annulus section (22) and / or the aortic section (23), and the intermediate section (24) comprise(s) a row (19a, 19b, 19c) of a plurality of cells, the cells (30, 40,50) of the plurality of cells, preferably each cell, being generally diamond-shaped and having four corners (c1, c2, c3, c4), respectively formed by two angularly connected struts (30a, 30b; 40a, 40b; 50a, 50b), with a first corner (c1) pointing towards the outflow end (11b) and a second corner (c2) pointing toward the inflow end (11a), and a third (c3) and a fourth (c4) corner pointing into the direction of the circumference c of the stent frame (17).

3. The prosthetic heart valve system (10) of any of the preceding claims, wherein the intermediate section (24) comprises a row of cells (19b) having between 3 and 12, preferably 6, cells (50).

4. The prosthetic heart valve system (10) of any the preceding claims, wherein a row of cells (19a, 19c) in the annulus section (22) and / or the aortic section (23), respectively, comprises between 6 and 24 cells (30; 40), preferably 9, 12 or 15 cells (30; 40), more preferably 12 cells (30; 40).

5. The prosthetic heart valve system (10) of any of the preceding claims, wherein each cell (50) in the row of cells (19b) in the intermediate section (24) comprises a cell area, such, that the cell area ratio of the cell area of each cell (50) in the row of cells (19b) in the intermediate section (24) to a cell area of each cell (30; 40) in the row of cells (19a, 19c) in the aortic (23) and annulus section (22) is at least from about 2:1 , preferably 3:1, to about 5:1.

6. The prosthetic heart valve system (10) of any of the preceding claims, wherein the annulus section (22) comprises a crown section (26), the crown section being comprised of a plurality of strut-elements (31; 27) outwardly protruding in the radially expanded configuration.

7. The prosthetic heart valve system (10) of claim 6, wherein a strut-element (31) of the plurality of the strut-elements (31), is formed of two angularly connected struts (31a, 31b) each having a first end (31a’; 31b’) and a second end (31a”; 31b”), the first ends of the two struts (31a’; 31b’) being connected with one another, and the second ends of the two struts (31a”; 31b”) being connected, respectively, to the third (c3) and fourth corner (c4) of a cell (30) of the row (19a) of cells of the annulus section (22), and / or to a first(30a) and second (30b) strut of two non-adjacent cells (30-1, 30-2) of the row (19a) of cells of the annulus section (22), and wherein preferably the strut-element (31) is arranged essentially parallel to the angularly connected struts (30a, 30b) forming the first corner (c1) of a cell (30) in a row (19a) of cells in the annulus section (22).

8. The prosthetic heart valve system (10) of claim 6 or 7, wherein the crown-section comprises exactly three strut-elements (31), which are circumferentially spaced at 120° in the crown section (26), or wherein only every second cell (30) in the row (19a) of cells of the annulus section (22) comprises a strut-element (31).

9. The prosthetic heart valve system (10) of claim 6, when depending on any of claims 2 to 5, wherein the strut-elements (27) outwardly protruding represent the two struts (30a, 30b) forming the first corner (c1) of a cell (30) of a last row (19a) of cells of the annulus section (22) and pointing towards the outflow end (11b), which last row (19a) of cells is directly adjacent to the row of cells (19b) of the intermediate section (24).

10. The prosthetic heart valve system of claim 9, wherein the crown-section comprises exactly three strut-elements (27), or wherein only every second or each cell (30) of the last row (19a) of cells of the annulus section comprises the strut-elements (27) outwardly protruding.

11. The prosthetic heart valve system (10) of any of claims 1 to 4, wherein in the intermediate section, between two adjacent cells (50’, 50”) of the row of cells, at least one rhomboid cell (52) is provided, the cell area of which is smaller than the cell area of the two adjacent cells (50’, 50”) of the row (19b) of cells in the intermediate section and smaller than the cell area of any of the cells (30, 40) of row of cells in the annulus section and in the aortic section, the rhomboid cell (52) having a first pair of edges (52a, 52b), being opposite to one another along a first diagonal e parallel to the longitudinal axis L, and a second pair of edges (52c, 52d), being opposite to one another along a second diagonal in the circumferential direction, wherein in the radially collapsed configuration, the length of the second diagonal f is longer than the length of the second diagonal in the radially expanded configuration.

12. The prosthetic heart valve system (10) of claim 11 , wherein between 3 and 12, preferably 3 rhomboid cells (52) are provided.

13. The prosthetic heart valve system (10) of any of the preceding claims, wherein the annulus section (22) and / or the aortic section (23) each comprise between 1 and 4 row(s) (19a, 19c) of cells.

14. The prosthetic heart valve system (10) of any of claims 2 to 13, wherein at the inflow end, the annulus section (22) has a first row (19a’) of cells, and wherein every second cell (30) of the first row of cells (19a’), at its second corner (c2) pointing toward the inflow end (11a), has a strut-attachment-means (60) protruding beyond the second corners (c2) of the cells (30) of the first row (19a’) of cells.

15. The prosthetic heart valve system (10) of any of the preceding claims, wherein the valve component (16) comprises a collapsible and expandable valve member (18) mounted within the stent frame (17) at the annulus section (22), wherein preferably the valve component (18) further comprises a skirt assembly mounted to the stent frame (17).

16. The prosthetic heart valve system (10) of any of the preceding claims, including the stent graft component (12) wherein the valve component (16) and the stent graft component (12) are connected with one another only via the graft element (14), with the stent element (13) and the stent frame (17) not being interconnected with each other through struts.

17. The prosthetic heart valve system (10) of any of the preceding claims, including the stent graft component (12) wherein the stent element (13) comprises a plurality of stent springs (13’, 13”, 13’”, 13””), which stent springs (13’, 13”, 13’”, 13””) are not connected via one another through struts, and which stent springs (13’, 13”, 13’”, 13””) are attached, preferably sewn, at intervals, to the graft element (14).

18. The prosthetic heart valve system (10) of claim 17, wherein the stent springs (13’, 13”, 13’”, 13””) are circumferentially undulating and forming bends, which bends are alternately oriented toward the outflow end and the inflow end, and which stent springs (13’,13”, 13”’, 13””) are aligned along the longitudinal axis L of the stent graft component (12), such, that a bend of a first stent spring (30’), which bend is oriented toward the outflow end, is aligned with a bend of a spaced apart second stent spring (30”) oriented towards the outflow or inflow end.

19. The prosthetic heart valve system (10) of any of the preceding claims, wherein the aortic section (23) and the annulus section (22), in the radially expanded configuration, have a larger diameter than the intermediate section (24).

20. The prosthetic heart valve system (10) of any of the preceding claims for anchoring to the cardiovascular system of a patient, including the stent graft component (12) and the valve component (16), wherein the stent graft component (12) is sized and configured for being anchored in a target artery, preferably in the ascending aorta above the sino-tubular junction, and wherein the valve component (16) is sized and configured for being anchored in the target valve complex of a patient, preferably in the region of the annulus, sinuses of Valsalva, coronary ostia, native leaflets and cusps and sino-tubular junction of the aortic complex.

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