Heart valve implants

Abstract

The present invention relates to an artificial heart valve (20), which comprises a generally tubular stent support (102) and a valve structure (118). The stent support (102) comprises a plurality of rows (150, 151, 152, 154, 156, 158, 159, 161) of diamond-shaped unit structures (110), and crowns (135) at its distal end (107) and proximal end (103), and three V-shaped openings, which are open to the distal end (107) of the stent support (102).

Description

[0001] This application is a divisional application of Chinese patent application No. 201510111484.1, whose application date is March 13, 2015 and whose invention name is “Heart Valve Implant”. Technical Field

[0002] The present invention relates to artificial heart valves for replacing the body's natural valves. Background Art

[0003] Heart valve replacement is necessary when the congenital heart valve is damaged, malfunctions or does not work. In the heart, the heart valve maintains a unidirectional flow of blood by opening and closing depending on the pressure difference on each side. Therefore, the heart valve may be affected by a variety of diseases and may therefore require heart valve replacement. The heart valve may become leaky, i.e., regurgitant, or insufficient, in which case the aortic valve is not functional and blood passively flows back to the heart in the wrong direction. In addition, the heart valve may become partially closed, i.e., stenotic, in which case the heart valve cannot open completely, thereby hindering the flow of blood from the heart. These two situations often exist at the same time.

[0004] Heart valve replacement usually requires a median sternotomy and therefore open heart surgery, which is a major impact on the treated patient: the sternum is sawn in half and after opening the pericardium, the patient is placed on a cardiopulmonary bypass machine. After the patient is placed on the bypass machine, the patient's diseased aortic valve is removed and a mechanical or fabric heart valve is placed in its place. In addition to the physical stress associated with the procedure, there is also the risk of death or serious complications caused by open heart surgery, which depends particularly on the patient's health and age.

[0005] However, systems have been developed that allow percutaneous introduction and placement of artificial heart valves, by which open-heart surgery can be avoided. The placement of such heart valve prostheses obtained can be retrograde, ie against the direction of normal blood flow, or antegrade, in line with blood flow.

[0006] For percutaneous heart valve replacement, a variety of types and structures of artificial heart valves are currently used, wherein the actual shape and structure of any particular artificial heart valve depends on the heart valve being replaced. Typically, artificial heart valve designs attempt to replicate the function of the heart valve being replaced and therefore typically include a valve leaflet-like structure used in conjunction with a bioprosthesis or a mechanical heart valve prosthesis, wherein the bioprosthesis is typically prepared from animal tissue (animal heart valve tissue or animal pericardial tissue) and treated to prevent rejection and to prevent calcification, and the mechanical heart valve prosthesis is typically composed entirely of synthetic or non-biological materials. Thus, a replacement valve may include a segment with a valve that is somehow mounted within a (self) expandable stent support. The valve structure is typically mounted on two types of stents: self-expanding stents and balloon-expandable stents. In order to place such a heart valve in a delivery device and ultimately in a patient, the valve must first be folded or bent to reduce its circumferential size.

[0007] When the collapsed artificial valve reaches the ideal implant site in the patient (i.e., at or near the annulus of the patient's heart valve to be replaced by the artificial valve), the artificial valve is unfolded or released from the delivery device and expanded to the full size of the operation. In the case of a balloon-expandable valve, the entire valve is usually released and then expanded by an expandable balloon placed in the valve stent. In the case of a self-expanding valve, the placement system usually includes a retractable sheath, after which the stent automatically begins to expand.

[0008] For a fully functional artificial heart valve, it is crucial that all its components fulfill their respective tasks: On the one hand, the valve needs to be adequately connected to the stent support, because otherwise the valve is prone to failure, and valve failure has serious consequences for the patient in the circulatory system. On the other hand, the stent support needs to be fully expanded and thus ensure safe fixation in the heart vessel.

[0009] Therefore, there is a continuing need to improve currently available placement systems and prosthetic heart valves to facilitate the manipulation of the prosthetic valve when loaded onto the placement system to deliver it to the valve to be replaced, while ensuring smooth and easy release of the prosthetic heart valve into the heart vessels.

[0010] Therefore, an object of the present invention is to provide an artificial heart valve which meets the above requirements and overcomes the disadvantages of currently used heart valve prostheses. Summary of the invention

[0011] This and other objects are solved according to the present invention by a prosthetic heart valve for replacing a patient's native valve, wherein the prosthetic heart valve comprises (i) an expandable generally tubular stent support forming a wire frame; The invention relates to a stent support having a proximal end, a proximal portion, a middle portion, a distal portion, and a distal end, an inner region, a longitudinal axis extending from the proximal end to the distal end, and a circumference, wherein the proximal end includes a crown portion having a plurality of free peaks pointing in the proximal direction, and the distal end includes a crown portion having a plurality of free peaks pointing in the distal direction, and wherein the tubular stent support includes a plurality of adjacent rows of interconnected rhombus-shaped cell structures extending between the proximal end and the distal end; the artificial heart valve also includes (ii) a valve structure, the valve structure having a plurality of valve leaflets (i.e., at least two, preferably three valve leaflets), a valve skirt, and a plurality of valve commissures, and wherein the valve is attached to the inner region of the stent support so that in the proximal portion, the inner surface of the tubular stent support is lined with the valve, thereby forming a sealing area, the valve, in the region between the distal end and the middle portion, is fixed to the stent support via the valve commissures, and the stent support has a valveless portion in the region between the distal end and the middle portion. Furthermore, the distal end of the stent support has, at its crown, only three free peaks pointing in the distal direction, wherein each of the three peaks pointing in the distal direction has a connecting line extension structure having a first line segment and a second line segment, the first line segment being substantially parallel to the longitudinal axis and having a generally longitudinal shape extending from the distal end in the proximal direction, and at least a portion of the second line segment extending in a direction perpendicular to the longitudinal axis.

[0012] The artificial heart valve according to the invention is also particularly suitable for being loaded and introduced into the heart via a loading and placement system suitable for artificial heart valves. The special shape of the prosthesis together with the connection line extension structure at the distal end of the artificial heart valve according to the invention allows the prosthesis to be easily and accurately loaded onto / into the placement system and allows accurate placement at the target site.

[0013] By using the artificial heart valve and the placement system thereof, continuous blood flow is ensured during the placement of the artificial heart valve: via three connecting wire extension structures, the distal end of the artificial heart valve can be reliably fixed in the catheter end of the placement system.

[0014] With the distal end securely attached in the tip of the placement system, balloon deployment can be achieved with the possibility of separately releasing the distal end of the prosthetic heart valve - by moving the tip - and the proximal end of the prosthetic heart valve - by not fully retracting the sheath compressing the prosthetic heart valve. This partial release of the prosthetic heart valve is desirable, since only with partial, balloon expansion of the prosthetic heart valve is it possible to assess its size and arrangement and its planned position without compromising blood flow.

[0015] Thus, by means of the special features of the artificial heart valve according to the invention, a safe and releasable connection to the fixing and placement system is achieved, while ensuring safe placement within the blood vessel after the artificial heart valve is released in the desired position. The interaction of the special design and features of the artificial heart valve according to the invention provides a heart valve that immediately takes over the function of the replaced congenital valve after deployment.

[0016] As used herein, the term "proximal" when used in conjunction with an artificial heart valve refers to the end of the heart valve closest to the heart when the heart valve is implanted in a patient, and the term "distal" when used in conjunction with an artificial heart valve refers to the end of the heart valve farthest from the heart when the heart valve is implanted in a patient. Therefore, in current usage, the term "distal direction" indicates a direction pointing toward the distal end of the artificial heart valve, and the "proximal direction" indicates a direction pointing toward the proximal end of the artificial heart valve.

[0017] According to the present invention, the connecting line extension structure has a first line segment and a second segment, wherein the first line segment is substantially parallel to the longitudinal axis and has a generally longitudinal shape extending from the distal end in the proximal direction, and at least part of the second segment extends in a direction generally perpendicular to the longitudinal axis. The term "generally" when used in this article refers to parallel or perpendicular within 15 degrees, respectively, and also includes parallel or almost parallel or perpendicular or almost perpendicular structures. In particular, with respect to the second segment extending at least partially in a direction generally perpendicular to the longitudinal axis, embodiments are included, wherein the embodiment has a second segment representing a longitudinal line segment generally perpendicular to the longitudinal axis, and embodiments are included, wherein the embodiment has a second segment that is substantially circular or elliptical or square in shape, whereby a portion of the circular or elliptical shape extends perpendicular to the longitudinal axis.

[0018] Therefore, and according to one embodiment, the shape of the second section is selected from substantially circular, oval, square or longitudinal. According to the present invention, these shapes also include circular, oval, square or longitudinal shapes.

[0019] Thus, in embodiments with a second segment having an eh circular or elliptical shape, at least a portion of the circular / elliptical / square / longitudinal shape extends in a direction perpendicular to the longitudinal axis and another portion of the second segment extends in the longitudinal direction.

[0020] According to a preferred embodiment, the connecting line extension structure having a first line segment substantially parallel to the longitudinal axis and having a generally longitudinal shape extending from the distal end in the proximal direction and a second line segment extending at least partially in a direction perpendicular to the longitudinal axis is generally T-shaped.

[0021] Furthermore, as used herein, and as is generally understood, the term "T-shaped" refers to any form or structure of the peak extension of the crown of the stent support, and due to the diamond-shaped unit, it resembles the letter "T", that is, a structure in which a first rod-shaped or rod-shaped first (wire) structure or segment having a first end and a second end has another second rod-shaped or rod-shaped (wire) structure or segment arranged vertically at one end thereof, and the second rod-shaped or rod-shaped structure can be shorter than the first rod-shaped (wire) structure.

[0022] Therefore, the "T-shaped wire extension structure" of the artificial heart valve according to the present invention points in the distal direction, whereby the second rod-like (wire) structure arranged vertically represents the outermost or final end, and whereby the first rod-like first (wire) structure connected to the second rod-like (wire) structure arranged vertically via its first end is arranged or mounted to the stent support via its second end, more specifically, arranged or mounted to the crown at the distal end of the stent support / artificial heart valve. However, it is obvious from the present disclosure that the "rod-like" structure does not necessarily have to be a uniform cylindrical form or shape, but may have portions with larger or smaller diameters. In addition, the second rod-like structure arranged vertically on the first end of the first rod-like structure may be slightly curved.

[0023] Therefore, and according to one aspect of the artificial heart valve of the present invention, the connecting line extension structure has a first line segment and a second line segment, the first line segment has a first end and a second end, the first line segment is substantially parallel to the longitudinal axis of the stent support, at least a portion of the second line segment is substantially parallel to the periphery of the stent support, and the second line segment is formed at the second end of the first line segment.

[0024] According to another embodiment, the connecting line extension structure has a second line segment, and the shape of the second line segment is selected from a circle, an ellipse or a square.

[0025] At present, "at least a portion" with respect to a second line segment is intended to indicate a line segment that is formed completely (i.e. all parts of the second line segment) perpendicular to the longitudinal axis, or that the second line segment also has a portion extending, for example, in the direction of the longitudinal axis of the stent support. For example, a circular or elliptical or square second line segment will always have a portion extending in a direction perpendicular to the longitudinal axis of the stent support, as well as a portion parallel to the longitudinal axis of the stent support.

[0026] The wireframe of the stent support is preferably made of a shape memory material such as nickel titanium alloy (e.g., Nitinol) or a very high tension material that will expand from its compressed state to its original state after the external force is removed. Utilizing this material, the support structure can be self-expanded from a contracted state to an expanded state, such as by applying heat, energy, etc., or by removing an external force (e.g., a compressive force). This support structure can be repeatedly compressed and expanded without damaging the structure of the stent support. In addition, the support structure of such an embodiment can be laser cut from a single piece of material or can be assembled from a variety of different components. For these types of artificial heart valves with stent supports, an example of an available delivery system includes a catheter with a retractable sheath that covers the artificial heart valve until it is placed, at which time the sheath can be retracted to allow the stent support (and therefore, the artificial heart valve, as well) to expand. Alternatively, the artificial heart valve of the present invention can be implanted using conventional surgical techniques and / or minimally invasive surgical methods. In this case, the artificial heart valve of the present invention can advantageously require relatively few sutures or no sutures to fix the stent to the anatomical position in the patient.

[0027] The prosthetic heart valve is preferably a prosthetic aortic valve and is intended to replace or support a congenitally diseased aortic valve.

[0028] The heart has four valves to ensure that blood does not flow in the wrong direction, for example, to ensure that blood does not flow back from a ventricle into the corresponding atrium. The valve between the left atrium and the left ventricle is the mitral valve, the valve between the right atrium and the right ventricle is the tricuspid valve, and the pulmonary valve is at the opening of the pulmonary artery. The aortic valve is a one-way valve between the heart and the aorta (the main artery from the heart that distributes oxygen-rich blood to the body). The aortic valve usually has three small pieces or leaflets that open widely and close securely to regulate blood flow, allowing blood to flow from the heart to the aorta and preventing blood from flowing back into the heart. Aortic stenosis occurs when calcium deposits on the valve leaflets, limiting their mobility and limiting or blocking blood flow.

[0029] The claimed and described valve structures include a plurality of valve leaflets, a valve skirt portion, and a valve coaptation point or apex; the valve skirt portion representing the area of ​​the valve structure used to connect the valve structure to a stent support (e.g., by sutures).

[0030] The leaflets of the valve structure move to open and close in response to the pressure differential caused by the pumping of the heart. Normally, the mitral valve has two leaflets and the tricuspid valve has at least two, preferably three leaflets. The aortic valve and the pulmonary valve normally have at least two, preferably three leaflets, which are also commonly referred to as "cusps" due to their semi-lunar appearance. In this disclosure, the terms "leaflet" and "cusp" have the same meaning.

[0031] The valve leaflets of the prosthetic heart valve according to the present invention are composed of natural tissue or synthetic material and can be transformed from an open position for opening a patient's heart chamber to a closed position for closing the patient's heart chamber.

[0032] The valve skirt portion of the valve structure as currently described and as generally understood refers to the portion of the valve structure that extends from the valve leaflets and in the proximal direction. The valve leaflets can be formed integrally with the valve skirt portion, for example, a single piece of pericardium can be used to form the valve structure. Alternatively, the valve leaflets and the valve skirt may not be integral, and the valve leaflets and the valve skirt may be made of several parts and from different materials.

[0033] Thus, the skirt portion is composed of natural tissue or synthetic material and is used to mount the valve structure to the stent support, thus forming a sealing area in said area. The skirt portion can have different lengths and preferably extends from the commissure to the very end of the proximal end of the artificial heart valve, and said portion is used as a matching skirt to improve the seal against the aortic root.

[0034] As used herein, the expression "native tissue" refers to naturally occurring tissue, i.e., biological tissue obtained from a patient, another donor (homograft), or a non-human animal (xenograft). The expression also encompasses tissues prepared by tissue engineering, e.g., a combination of engineered extracellular matrices ("scaffolds"), cells, and bioactive molecules.

[0035] The valve structure of the artificial heart valve according to the present invention can therefore include xenograft / homograft or synthetic, non-biological materials. A homograft is a human donor valve, e.g., a heart valve, or a substitute made from human tissue (e.g., pericardial tissue), while a xenograft describes a valve received from an animal, e.g., a heart valve, or a valve made from animal tissue (e.g., pericardial tissue), typically porcine or bovine.

[0036] In a preferred embodiment, the prosthetic heart valve comprises bovine pericardium.

[0037] According to a preferred embodiment, the artificial heart valve, at its distal end, comprises three substantially V-shaped or U-shaped openings on its periphery, which are open to the distal end of the stent support. When used herein, i.e. throughout the present invention, and in particular with respect to V-shaped or U-shaped, "substantially" is intended to indicate the approximate shape or design of the opening, which, in the present invention, resembles the shape of the letter V or U. Slight deviations from these shapes are possible, which however still resemble the letter V or U, i.e. are substantially V-shaped or U-shaped.

[0038] According to a preferred embodiment of the artificial heart valve of the present invention, the rhombus unit structure is formed by two intersections forming a row of peaks, which are separated from each other along the longitudinal axis of the stent support and two intersections separated from each other relative to the periphery of the stent support, wherein the last row at the distal end includes only three rhombus unit structures, and the three rhombus unit structures are separated from each other around the periphery of the stent support so that they do not contact each other.

[0039] By providing only three diamond-shaped units, each with a peak pointing in the distal direction, the overall stent material at the distal end of the stent stent is greatly reduced, thereby facilitating attachment or fixation of the distal end of the stent stent within the loading structure. The connecting line extension structure of the three peaks in the last row matches the loading system engagement device, and the stent stent can therefore be easily loaded and compressed for placement in the patient's heart.

[0040] According to another preferred embodiment of the artificial heart valve according to the present invention, the penultimate row at the distal end, i.e., the row adjacent to the last row at the distal end, includes more rhombus unit structures than the last row at the distal end, wherein some of the rhombus unit structures in the penultimate row are spaced apart from each other around the periphery of the stent support, and wherein some of the rhombus unit structures in the penultimate row are in contact with each other.

[0041] In addition, according to another preferred embodiment of the artificial heart valve according to the present invention, the penultimate row at the distal end, adjacent to the last row at the distal end, includes six diamond-shaped unit structures, wherein the two unit structures of the penultimate row are respectively in contact with each other, thereby forming a unit structure pair, wherein the unit structure pairs of the penultimate row are separated from each other around the periphery of the stent support.

[0042] According to one refinement of the artificial heart valve according to the invention, the row adjacent to the penultimate row at the distal end in the proximal direction comprises more rhombus-shaped unit structures than the penultimate row at the distal end.

[0043] These embodiments provide an overall form of the distal end such that, due to a reduction in the number of rhombus-shaped units, wherein the reduction increases as one moves toward the distal end, the periphery of the tubular form of the artificial heart valve has alternating areas with and without wire frames, thereby forming three "tail"-like wire frames terminating at the distal end.

[0044] Although according to one embodiment of the prosthetic heart valve according to the present invention the tubular form of the stent support has a generally uniform diameter along its longitudinal axis, in other embodiments the prosthetic heart valve may have different or at least two different diameters along its longitudinal axis.

[0045] Hence, according to another embodiment of the prosthetic heart valve according to the invention, in the valveless portion the diameter of the tubular form of the stent support is reduced compared to the remaining tubular shape of the stent support.

[0046] According to one aspect of the invention, the prosthetic heart valve has its largest diameter at the proximal end compared to the remaining tubular shape of the prosthetic heart valve.

[0047] It is also preferred that the coaptation apex is flexible so that it moves inward during valve closure, thereby transferring the stresses generated by the pressure gradient from the pericardium (which, as a biological material, has unpredictable properties) to the stent support (which, as a synthetic material, has isotropic properties and predictable mechanical properties). Advantageously, this will protect the pericardial tissue and thus increase the expected service life of the prosthetic heart valve.

[0048] It will also be apparent to one skilled in the art that the length of the tubular prosthetic heart valve will depend on the valve to be replaced, on the patient, and on the overall condition of the patient's vasculature.

[0049] According to another embodiment of the artificial heart valve according to the present invention, a radiopaque marker is disposed in the middle portion of the stent support, i.e., in the transition region between the leaflets and skirt portion of the valve. This allows the user to accurately understand the valve / leaflet level in each placement state. Preferably, the radiopaque marker is made of or contains a material selected from gold, platinum alloy tantalum or other radiopaque materials. In addition, the form of the marker can be any form, such as circular, square, oval, etc. The marker is preferably connected to the stent support via riveting, bonding or other attachment / mounting means.

[0050] Currently, and throughout this invention and as generally understood, the term "substantially" used herein in conjunction with the accompanying adjective shall also include not only the exact definition of the adjective (such as, for example, parallel), but also minor and subtle deviations thereof, which nevertheless fall under the general and overall definition of the adjective.

[0051] The prosthetic heart valve according to the invention is particularly suitable for use with the placement system according to the invention. The prosthetic heart valve and the placement system interact in such a way that when the placement system has been actuated so as to place the prosthetic heart valve loaded thereon in a balloon-like released state, the native valve can still be passed, which allows very precise positioning. In addition, the prosthesis is fully reloadable, since it can be retracted into the sheath in the event that its removal or replacement should be necessary.

[0052] Furthermore, after the distal end of the prosthetic heart valve in its loaded state (fixed in the cusp) has been released, the cusp can be moved within the expanded end of the prosthesis, thereby preventing the cusp from interfering with the valve material, which could otherwise cause damage to the prosthetic heart valve.

[0053] Furthermore, with the very specific design of the prosthetic heart valve, the formation of a "parachute" that could impede blood flow can be avoided because the prosthesis can be placed exactly at the desired site and the prosthetic heart valve is fully functional after the proximal end is placed.

[0054] According to another aspect of the prosthetic heart valve according to the invention, the prosthetic heart valve, in the region where the intermediate portion transitions into the proximal portion, comprises a portion that is concave relative to the longitudinal axis of the stent support.

[0055] Currently, and as is generally understood, when used herein, the expression "concave" refers to a form of inward curvature as opposed to outward curvature (i.e. as opposed to convex). Thus, the wall or wireframe of the stent support or prosthetic heart valve is thus curved inwardly in this region, and not only on one side, but over its entire periphery. The degree of inward curvature may be only slight.

[0056] The advantage of this embodiment is that the calcium packages present mainly in congenital valve leaflets with calcific stenosis can be better adapted to the calcium packages present mainly in congenital valve leaflets with calcific stenosis, by means of the concave form in this area, i.e. the sealing portion is filled with the valve structure and placed where the native valve is located. Thus, the concave shape is intended to be securely fixed around the anatomical structure of, for example, a calcified congenital aortic valve.

[0057] The present invention also relates to a method for releasing an artificial heart valve according to the present invention loaded on a placement system, the placement system comprising a catheter, a shaft, a sheath, a tip and a drive mechanism, the method comprising the following steps:

[0058] providing a placement system having an expandable prosthetic heart valve according to the present invention loaded thereon,

[0059] actuating a drive mechanism of the placement system to progressively retract the sheath, thereby releasing the middle portion of the prosthetic heart valve, whereby the distal end of the prosthetic heart valve remains fixed within the tip, and the proximal end of the prosthetic heart valve remains fixed within the distal end of the shaft, thereby allowing balloon-like expansion of the prosthetic heart valve,

[0060] moving the tip and thereby releasing the distal end of the prosthetic heart valve,

[0061] and fully retracting the sheath and fully deploying and releasing the inflatable prosthetic heart valve.

[0062] With the method described herein, accurate placement of the prosthetic heart valve is possible. In addition, the method of use of the present invention allows a doctor or surgeon to carefully place and even re-place the prosthetic heart valve without being under time pressure to place the prosthetic heart valve in time so as not to obstruct blood flow. Because with the method according to the present invention, a balloon-like intermediate step of placing the prosthesis is created, the flow of blood through the prosthetic heart valve is ensured, thus providing time for careful placement of the prosthetic heart valve. In addition, with the method according to the present invention, the released end of the prosthesis is prevented from opening.

[0063] According to an improvement of the present invention, the method further comprises the following steps after the providing step:

[0064] The placement system is positioned so that the prosthetic heart valve is in the area of ​​the heart valve to be replaced by the prosthetic heart valve.

[0065] It is to be understood that the above-mentioned features and the features still to be described below fall within the scope of the present invention not only in the respectively stated combination but also in different combinations or alone, so that the present disclosure should be regarded as also particularly directed to other embodiments with other possible combinations.

[0066] Preferred embodiments are shown in the drawings and are described in more detail below. BRIEF DESCRIPTION OF THE DRAWINGS

[0067] In the figure:

[0068] Figure 1A , 1B and 1C show an exemplary embodiment of an artificial heart valve according to the present invention, wherein Figure 1A , 1B and 1C each show the same embodiment; for clarity, Figure 1A , 1B and 1C, not every feature described in the following specification is shown in each of 1A, 1B and 1C, but the corresponding features are discussed with respect to the corresponding figures. DETAILED DESCRIPTION

[0069] In the following, the description is shown in Figure 1A , 1B and 1C, wherein reference numerals for features of the embodiments are for Figure 1A , 1B and 1C are identical. It goes without saying that the Figure 1A , 1B The features indicated in each of 1C are the same as for the corresponding other figures.

[0070] The artificial heart valve 20 has an expandable generally tubular stent support 102 formed into a wire frame. The stent support 102 has a proximal end 103, a proximal portion 104, a middle portion 105, a distal portion 106, and a distal end 107. The stent support 102 also has an inner region, a longitudinal axis 131 extending from the proximal end 103 to the distal end 107, and a periphery 132.

[0071] The proximal end 103 and the distal end 107 each include a crown having a plurality of free peaks 134, 112: at the proximal end 103, the peaks 134 point in the proximal direction 202, and at the distal end, the peaks 112 point in the distal direction 204. As described above, the "distal direction" refers to the direction in which the distal end 107 of the prosthetic heart valve 20 points, and the "proximal direction" refers to the direction in which the proximal end 103 of the prosthetic heart valve points.

[0072] As can be seen from FIG. 1 , the tubular stent support further includes a plurality of adjacent rows of interconnected diamond-shaped unit structures 110 extending between the proximal end 103 and the distal end 107 .

[0073] The diamond-shaped unit structure 110 may be, for example, laser cut or formed by interweaving or braiding metal (preferably Nitinol) wires.

[0074] As shown in FIG. 1 , the diamond-shaped unit structures 110 are arranged in adjacent rows, wherein each of the diamond-shaped unit structures 110 is defined by a series of lines or line segments of the wireframe formed by the stent support 102: due to the diamond shape of these unit structures 110, at least one "peak" of each diamond-shaped unit structure 110 in one row coincides with a "valley" created by two circumferentially adjacent diamond-shaped unit structures 110 in an adjacent row. Thus, a single row includes a plurality of diamond-shaped unit structures 100 that are circumferentially adjacent to each other around the stent support 102. Thus, similarly, a row of diamond-shaped unit structures 110 that is adjacent to another row that includes a plurality of diamond-shaped structures 110 (referred to herein as an "adjacent row") is a row that is closest to or interconnected with the diamond-shaped unit structures 110 of the other row along the longitudinal direction of the stent support 102.

[0075] In addition, when used herein, a "diamond" shaped unit structure is generally intended to refer to the line-divided, four-sided lattice shape 110 in FIG. 1, which includes intersections where two adjacent lines or line segments meet. As shown in FIG. 1, each diamond unit structure 110 has four intersections, namely two intersections spaced from each other along the longitudinal axis 131 of the stent support 102, which are referred to as "peaks" 133, 134 of a row (or they can be referred to as "valleys" of adjacent rows). The diamond unit structure 110 also includes two intersections spaced from each other relative to the perimeter 132 of the stent support 102.

[0076] At the distal end 107, the stent support 102 includes a crown 135 with three free peaks 112, i.e., the three diamond-shaped units 110 at the distal end 107 each have a free peak 112. Thus, when used in conjunction with "peak", the term "free" is intended to refer to a peak or intersection that is not connected to or adjacent to another unit structure 110 or forms an edge with another unit structure 110. As can also be seen in Figure 1, the three free peaks 112 of the diamond-shaped expandable unit structure 110 pointing in the distal direction each have a connecting line extension structure 114. In the embodiment shown, the connecting line extension structure is T-shaped.

[0077] The three attachment line extension structures 114 present on the three free peaks 134 are used for attachment / connection to a delivery system and are specifically configured to allow for removable attachment / connection of the stent support 102 relative to the delivery system.

[0078] The embodiment of the artificial heart valve 10 shown in the figures has a generally T-shaped connecting line extension structure 114. Currently, and as mentioned above, the expression "T-shaped" refers to any form or design of the free peak 112 of the unit structure 110 having the shape of the letter "T".

[0079] As shown in Figure 1 (particularly Figure 1C As can be seen in the figure, the connecting wire extension structure 114 includes a first wire extension segment and another second wire extension segment, the first wire extension segment extends substantially parallel to the longitudinal axis 131 of the stent support 102, and the second wire extension segment extends substantially parallel to the periphery 132 of the stent support 102. As such, the second wire extension segment can have any other form, such as a circular or oval or square shape, with at least a portion perpendicular to the longitudinal axis 131 of the stent support 102. The first and second wire extension structures together form a connecting wire extension structure suitable for engagement with a corresponding engagement element (not shown) of a placement system.

[0080] In addition, and if Figure 1C As shown in , the first wire extension structure has a first end and a second end. With its first end, the connecting wire extension structure is connected to one of the three free peaks / ends 112 of the stent support 102 (or formed integrally therewith), while the other second end is combined / connected with the second wire extension segment or formed integrally therewith.

[0081] 1 , the middle portion 105 of the stent support 102 carries a radiopaque marker 116, thereby facilitating the positioning and placement of the prosthetic heart valve 20. In addition, the size of the cell structure 110 in the distal portion 106 of the stent support 102 is larger than the size of the cell structure 110 in the proximal portion 104 of the stent support 102.

[0082] As in Figure 1A ,1B and 1C, and in particular according to Figure 1B The artificial heart valve 20 further includes a valve structure 118 having a plurality of (i.e., three) valve leaflets 119 and a plurality of valve commissures 120. The valve structure 118 further includes a valve skirt 121, which is attached to the stent support 102 so that the valve structure 118 partially fills the inner region of the stent support 102, thereby forming a sealing area in the proximal portion 104, wherein the inner region of the tubular stent support 102 is filled by the valve skirt 121.

[0083] As mentioned above, the material of the stent support 102 is preferably made of Nitinol or any other metal having shape memory properties.The valve may be a donor valve, such as a valve from a mammal, or an artificial valve.

[0084] Furthermore, in the artificial heart valve 20 according to the present invention, the valve structure 118 is fixed to the stent support 102 (i.e., via its engagement points 120) in the region 108 between the distal end 107 and the middle portion 105, and preferably in the distal portion 106 of the stent support 102. Furthermore, in the region 108 between the distal end 107 and the middle portion 105, the stent support 102 has a valveless portion.

[0085] As described above, the coaptation apex / point 120 is flexible and moves inwardly during valve closure.

[0086] also, Figure 1A , 1B 1C shows that the artificial heart valve 20 includes a concave portion 160, i.e., a portion or segment 160 of the tubular stent support 102 having concave walls (i.e., walls that are curved inwardly (relative to the tubular structure)) in the region where the middle portion 105 transitions to the proximal portion 104. This feature allows for better accommodation of the calcium packs that are typically present in the congenital valve leaflets.

[0087] The concave form of the portion 160 may be achieved, for example, by configuring the stent support 102 in this portion as a diamond-shaped cell structure 110 with a lower expansion force than the diamond-shaped cell structures in other areas of the stent support 102. The lower expansion force may be achieved, for example, by cutting the stent structure from a Nitinol tube of a specific length and thickness; to form the desired stent structure 102, the structure cut from the tube is thermally expanded with the aid of a special tool mandrel until the desired diameter is reached; by using a tool mandrel with a different diameter, thus making it possible to produce regions or portions of the tube / stent structure 102 with different diameters.

[0088] See again in particular Figure 1C, the stent support 102 comprises a series of adjacent rows of rhombus-shaped unit structures 110. In particular, the stent support 102 comprises a first row 150 of such unit structures at the proximal end 103 of the stent support 102, which is followed in the longitudinal direction and towards the distal end by or adjacent to a row 151 of rhombus-shaped unit structures 110. Row 151 preferably comprises as many unit structures 110 as row 150; each structure of row 151 shares at least a portion of two line segments with a unit structure 110 of row 150. Row 151 is followed in the distal direction by row 152, which preferably comprises as many unit structures 110 as row 151; each structure of row 152 shares at least a portion of two line segments with a unit structure 110 of row 151.

[0089] The next row 154 adjacent to the row 152 also includes the same number of diamond-shaped unit structures 110 as the rows 150 and 152 .

[0090] Then, row 156, which is adjacent to row 154, includes fewer diamond-shaped unit structures 110, and therefore, row 156 includes unit structures 110 that are considered adjacent in the same row without contacting each other; in other words, they are spaced apart from each other around the perimeter of stent support 102. Thus, a "gap" is formed between cells 164 and 165 of row 156.

[0091] Furthermore, as can also be seen from FIG. 1 , the row 156 comprises not only one gap, but three gaps which are separated or spaced apart from each other at a periodic distance: this is due to the fact that the row 156 “lacks” three rhombus unit structures 110 at the same periodic distance.

[0092] Furthermore, row 158, which is adjacent to row 156 towards the distal end 107 of the stent support 102, again comprises fewer rhombus-shaped unit structures 110 than row 156, a feature which therefore makes the gaps between the cells 174, 175 of row 158 larger than the gaps of row 156. Furthermore, as can also be seen in FIG. 1 , the gaps present in row 158 are adjacent to the gaps of row 156, thereby providing—together with the gaps in the adjacent, subsequently larger, adjacent rows 159 and 161—a terminal V-shaped opening on the periphery of the stent support 102.

[0093] As already described for row 156, each of rows 158, 159 and 161 also includes not just one gap, but three gaps that are separated or spaced apart from each other at periodic distances around the periphery of the stent support 102 and are adjacent to the gaps in the previous (i.e., more proximal) row, thereby enlarging the V-shaped or U-shaped opening in the wall or periphery 132 of the stent support 102.

[0094] If Figure 1A , 1B1C , the last row 190 at the distal end 107 of the stent support 102 only (ie, solely or exclusively) includes three rhombus-shaped unit structures 110 , the peaks of which respectively form a distal crown 135 having a connecting line extension structure 114 .

[0095] Thus, the stent support 102 of the artificial heart valve 20 has three V-shaped or U-shaped openings that open toward the distal end 107. Thus, the three "V"s or "U"s formed in the periphery 132 of the stent support toward the distal end 107 each represent an end opening on the periphery 132 of the artificial heart valve 20, which are separated from each other by a tail-like structure formed by the unit structures 110 that are continuously reduced in rows 156, 158, 159, and 160.

[0096] The flap structure 118 is secured to the stent support 102 via its junction or apex 120 such that the junction 120 is located in the region of the tail-like structure.

[0097] Also by Figure 1A , 1B As can be seen in Figures 1 and 1C, in the distal portion 106, the diameter of the stent support 102 is smaller than the diameter of the stent support 102 in the other stent support portions.

[0098] Although different embodiments of the present invention have been described, it is obvious to those skilled in the art that more embodiments and implementations are possible within the scope of the present invention. In addition, although different indications have been given about the scope of the present invention, the present invention is not limited to any one of these, but may consist of two or more of these combined together. Therefore, the present invention is not limited except according to the attached claims and their equivalents.

Claims

1. An artificial heart valve (20) for replacing a patient's congenital valve, wherein the artificial heart valve (20) comprises: An expandable generally tubular stent support (102) forming a wireframe and having a proximal end (103), a proximal portion (104), a middle portion (105), a distal portion (106) and a distal end (107), an interior region, a longitudinal axis (131) extending from the proximal end (103) to the distal end (107), and a periphery (132), wherein the proximal end (103) and the distal end (107) each include a crown having a plurality of free peaks (112) pointing in proximal (202) and distal (204) directions, respectively, and wherein the tubular stent support (102) includes a plurality of adjacent rows (150, 151, 152, 154, 156, 158, 159, 161) of interconnected rhombus-shaped unit structures extending between the proximal end (103) and the distal end (107), a flap structure (118), wherein the flap structure (118) has a plurality of flap leaflets, a flap skirt (121), and a plurality of flap coaptation apexes (120), and wherein the flap structure (118) is attached to the inner region of the stent support (102) so that in the proximal portion (104), the inner surface of the tubular stent support (102) is covered with the flap structure (118), thereby forming a sealing area, wherein the flap structure (118) is fixed to the stent support (102) via the coaptation apexes (120) in the region (108) between the distal end (107) and the middle portion (105), and the stent support (102) has a flapless portion in the region (108) between the distal end (107) and the middle portion (105), Features The distal end (107) of the stent support (102) has only three free peaks (112) at its crown (135), each of which has a connecting line extension structure (114), the connecting line extension structure having a first line segment (115), the first line segment (115) being substantially parallel to the longitudinal axis and having a generally longitudinal shape extending from the distal end in the proximal direction, and the connecting line extension structure having a second line segment (117), at least part of which extends in a direction perpendicular to the longitudinal axis, and The rhombus unit structures (110) are formed by two intersection points spaced apart from each other along the longitudinal axis (131) of the stent support (102) and two intersection points spaced apart from each other relative to the periphery of the stent support, of the peaks (134) forming a row (150, 151, 152, 154, 156, 158, 159, 161), wherein the last row at the distal end (107) includes only three rhombus unit structures (110), the three rhombus unit structures (110) being spaced apart from each other around the periphery of the stent support (102) such that they do not contact each other, wherein the tubular shape of the stent support (102) is flexible (114) at the fixed site of the coaptation apex (120) of the valve structure (118) at the stent support (102), and wherein in the region where the intermediate portion (105) transitions to the proximal portion (104), the artificial heart valve (20) comprises a region (160) that is recessed relative to the longitudinal axis (131) of the stent support (102) to accommodate the calcium packing of the leaflets of the congenital valve; At the distal end (107), the diameter of the tubular shape of the stent support (102) in the valveless portion is reduced compared to the remaining tubular shape of the stent support (102); and / or, the artificial heart valve has a maximum diameter at the proximal end compared to the remaining tubular shape of the artificial heart valve.

2. The artificial heart valve (20) according to claim 1, characterized in that The artificial heart valve (20) includes three V-shaped or U-shaped openings in its periphery (132) at its distal end (107), and the V-shaped or U-shaped openings are open to the distal end (107) of the stent support (102).

3. The artificial heart valve (20) according to claim 1, characterized in that The row (159) adjacent to the last row (161) at the distal end (107) includes more diamond-shaped unit structures (110) than the last row at the distal end (107), wherein some of the unit structures (110) are spaced apart from each other around the periphery (132) of the stent support (102), and wherein some of the unit structures (110) are in contact with each other.

4. The artificial heart valve (20) according to claim 3, characterized in that The second to last row (159) at the distal end (107) adjacent to the last row (161) at the distal end (107) includes six diamond-shaped unit structures (110), wherein two unit structures (110) are respectively in contact with each other, thereby forming a unit structure pair, wherein the unit structure pairs are spaced apart from each other around the periphery (132) of the stent support (102).

5. The artificial heart valve (20) according to any one of claims 1 to 4, characterized in that A row (158) adjacent to the penultimate row (159) at the distal end (107) in the proximal direction (202) includes more rhombus-shaped unit structures (110) than the penultimate row (159) at the distal end (107).

6. The artificial heart valve (20) according to any one of claims 1 to 4, characterized in that A radiopaque marker (116) is disposed in the middle portion (105) of the stent support (102).

7. The artificial heart valve (20) according to any one of claims 1 to 4, characterized in that The connecting line extension structure (114) has: a first line segment (115), the first line segment (115) having a first end (115a) and a second end (115b) and being substantially parallel to the longitudinal axis (131) of the support support (102); and a second line segment (117) located at the second end (115b) of the first line segment (115).

8. The artificial heart valve (20) according to any one of claims 1 to 4, characterized in that The second line segment (117) has a shape selected from circular, elliptical, square or longitudinal.

9. The artificial heart valve according to any one of claims 1 to 4, characterized in that The connecting line extension structure (114) is T-shaped.

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