Prosthetic valves

Abstract

The present disclosure relates to prosthetic valves. In an example, a prosthetic valve comprises a frame configured to transition between a radially expanded and a crimped state. The frame includes a plurality of strut rungs, each comprising a plurality of struts pairs arranged around a circumference of the frame. Each strut pair comprises two angled struts diverging from a mutual vertex to opposite junctures at which the angled struts are connected to axial frame members which are circumferentially spaced from each other. The plurality of strut rungs include an outflow rang defining an outflow end of the frame, an inflow rang defining an inflow end of the frame, and at least one intermediate rang therebetween.

Description

PROSTHETIC VALVESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 717,997, filed November 8, 2024, which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to implantable, radially expandable prosthetic devices, such as prosthetic valves.BACKGROUND

[0003] Native heart valves, such as the aortic, pulmonary and mitral valves, function to assure adequate directional flow from and to the heart, and between the heart's chambers, to supply blood to the whole cardiovascular system. Various valvular diseases can render the valves ineffective and require replacement with artificial valves. Surgical procedures can be performed to repair or replace a heart valve. Surgeries are prone to an abundance of clinical complications, hence alternative less invasive techniques of delivering a prosthetic heart valve over a catheter and implanting it over the native malfunctioning valve, have been developed over the years.

[0004] Different types of prosthetic heart valves are known to date, including balloon expandable valve, self-expandable valves and mechanically-expandable valves. Different methods of delivery and implantation are also known, and may vary according to the site of implantation and the type of prosthetic valve. One exemplary technique includes utilization of a delivery assembly for delivering a prosthetic valve in a crimped state, from an incision which can be located at the patient's femoral or iliac artery, towards the native malfunctioning valve. Once the prosthetic valve is properly positioned at the desired site of implantation, it can be expanded against the surrounding anatomy, such as an annulus of a native valve, and the delivery assembly can be retrieved thereafter.SUMMARY

[0005] The present disclosure is directed towards prosthetic valves defining generally V- shaped pairs of angled stmts between adjacent axial frame members thereof.

[0006] In one of its basic configurations, a prosthetic valve comprises a frame configured to transition between a radially expanded and a crimped state, wherein the frame comprises aplurality of axial frame members circumferentially spaced from each other and a plurality of strut rungs, wherein each strut rung a plurality of struts pairs arranged around a circumference of the frame. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0007] In some examples, each strut pair comprises two angled struts diverging from a mutual vertex to opposite junctures at which the angled struts are connected to two of the axial frame members.

[0008] In some examples, the plurality of strut rungs further comprises an outflow rung defining an outflow end of the frame, and an inflow rung defining an inflow end of the frame.

[0009] In some examples, the plurality of strut rungs comprises an intermediate rung disposed between the outflow rung and the inflow rung.

[0010] In some examples, the intermediate rung is a first intermediate rung distal to the outflow rung, and the plurality of rungs further comprises a second intermediate rung disposed between the first intermediate rung and the inflow rung.

[0011] In some examples, the plurality of axial frame members comprises a plurality of commissure support axial members, and a plurality of non-commissural axial members.

[0012] In some examples, each axial frame member comprises a plurality of axial segments, each extending between junctures of two of the strut rungs.

[0013] In some examples, the prosthetic valve further comprises a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.

[0014] In some examples, each leaflet comprises a free edge closer to the outflow end, and a cusp end portion closer to the inflow end.

[0015] In some examples, each two adjacent leaflets are coupled to each other at commissures attached to the commissure support axial member.

[0016] In some examples, the outflow axial segment of the commissure support frame member comprises a commissure window opening.

[0017] In some examples, the prosthetic valve further comprises a skirt disposed around the frame.

[0018] In some examples, the skirt extends from the inflow end to the vertices of the intermediate rung.

[0019] In some examples, the strut pairs of the inflow rung comprise: a plurality of strut pairs oriented towards the inflow end, each disposed between two strut pairs oriented towards the outflow end.

[0020] In some examples, the cusp end portions of the leaflets are coupled to the strut pairs of the inflow rung which are oriented towards the inflow end.

[0021] In some examples, midpoints of the cusp end portions are coupled to the vertices of the stmt pairs of the inflow rung which are oriented towards the inflow end.

[0022] In some examples, the stmt pairs of the inflow rung which are oriented towards the inflow end are configured to resiliently bend radially inwards when the leaflets move to a closed state in which the leaflets coapt with each other.

[0023] In some examples, two immediately adjacent non-commissural axial members are disposed between two immediately adjacent commissure support axial members.

[0024] In some examples, each stmt pair of the inflow mng, which is oriented towards the inflow end, extends between two non-commissural axial members.

[0025] In some examples, each stmt pair of the inflow mng, which is oriented towards the outflow end, extends between a commissure support frame member and a non-commissural axial member.

[0026] In some examples, the junctures connecting the stmt pairs of the inflow mng with the commissure support axial members define first inflow apices of the frame.

[0027] In some examples, the vertices of the stmt pairs of the inflow mng which are oriented towards the inflow end define second inflow apices which are distal to the first inflow apices.

[0028] In some examples, all of the stmt pairs of the outflow mng are oriented towards the inflow end.

[0029] In some examples, all of the stmt pairs of the inflow mng are oriented towards the outflow end.

[0030] In some examples, the frame further comprises a plurality of vertical stabilization stmts, each extending axially between vertices of two of the plurality of mngs.

[0031] In some examples, the vertical stabilization stmts are axially shorter than the axial frame members.

[0032] In some examples, at least two of the plurality of stmt mngs are devoid of vertical stabilization stmts extending therebetween.

[0033] In some examples, the vertical stabilization stmts extend between the inflow rung and the intermediate rung.

[0034] In some examples, an axial distance between junctures of the inflow rang and the intermediate rang is greater than an axial distance between the outflow rang and the intermediate rang.

[0035] In some examples, the strut pairs of the intermediate rang are parallel to the strut pairs of the inflow rang.

[0036] In some examples, all of the strut pairs of the intermediate rang are oriented towards the outflow end.

[0037] In some examples, the vertical stabilization struts extend between the outflow rang and the intermediate rang.

[0038] In some examples, an axial distance between junctures of the outflow rang and the intermediate rang is greater than an axial distance between the inflow rang and the intermediate rang.

[0039] In some examples, the strut pairs of the intermediate rang are parallel to the strut pairs of the outflow rang.

[0040] In some examples, all of the strut pairs of the intermediate rang are oriented towards the inflow end.

[0041] In some examples, the first intermediate rung and the second intermediate rang are connected to the axial frame members at mutual junctures.

[0042] In some examples, the first intermediate rang and the second intermediate rang together define a row of diamond-shaped cells.

[0043] In some examples, the vertices of all strut pairs which are circumferentially aligned with each other, are axially spaced from each other in the radially expanded state of the frame.

[0044] In some examples, the lengths of all of the angled struts are equal to each other.

[0045] In some examples, a medial free edge portion of the free edge of the leaflets is axially offset by a minimal axial distance from the outflow end of the frame.

[0046] In some examples, the minimal axial distance is greater than 1.5 millimeters.

[0047] In some examples, a lateral length of the medial free edge portion is greater than 70% of a total length of the free edge.

[0048] In some examples, the frame further comprises a plurality of top markers, each extending proximally from a corresponding one of the commissure support axial members and comprising a neck portion and a head portion.

[0049] In some examples, the top markers are configured to atraumatically engage a tissue when pressed thereagainst upon implantation of the prosthetic valve.

[0050] In some examples, a lateral length of the head portion is equal to or greater than 1 millimeter.

[0051] In some examples, a lateral length of the head portion is equal to or greater than 2 millimeters.

[0052] In some examples, the head portion is covered by a covering element.

[0053] In some examples, the covering element comprises a cap encapsulating the head portion.

[0054] In some examples, the neck portion is configured to bend when the top marker is pressed against the tissue.

[0055] In some examples, an axial length of the neck portion is greater than 2 millimeters.

[0056] In some examples, the neck portion is serpentine-shaped.

[0057] In some examples, a frame portion disposed on one side of the commissure support axial member includes a differently shaped feature compared to an equivalent feature of a frame portion disposed on the opposite side of the commissure support axial member.

[0058] In some examples, the differently shaped feature comprises a widened portion of a corresponding one of the non-commissural axial members.

[0059] In some examples, the widened portion comprises a uniform width along at least 75% of the length of the corresponding outflow axial segment, which is wider than the width of an equivalent axial segment of the opposite frame portion.

[0060] In some examples, the widened portion comprises a bulge of the corresponding axial frame.

[0061] In some examples, the bulge is circularly-shaped.

[0062] In some examples, the prosthetic valve further comprises an aperture extending through the bulge.

[0063] In some examples, the enlarged joint is one of the joints of the intermediate rung.

[0064] In some examples, the prosthetic valve further comprises an aperture extending through the enlarged joint.

[0065] In some examples, the vertices of the outflow mng comprise arcuate regions defined between upper and lower curved surfaces thereof.

[0066] In some examples, the vertices of the intermediate rung comprise arcuate regions defined between upper and lower curved surfaces thereof.

[0067] In some examples, the arcuate regions define a width which is less than a width of the angled struts continuously extending therefrom.

[0068] In some examples, the axial frame members are at least partially covered by at least one covering member.

[0069] In some examples, the outflow rung is covered by at least one covering member.

[0070] In some examples, the intermediate rung is covered by at least one covering member.

[0071] In some examples, the at least one covering member comprises a strip wrapped around a corresponding portion of the frame covered thereby.

[0072] In some examples, a radiopaque marker is attached to each of the commissures.

[0073] In some examples, the radiopaque marker is asymmetric.

[0074] In some examples, the radiopaque marker is C-shaped.

[0075] In some examples, a prosthetic valve can include any of the features recited in Examples 1-143 below.

[0076] The aspects of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.BRIEF DESCRIPTION OF THE FIGURES

[0077] Some examples of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some examples may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an example in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.In the Figures:

[0078] Fig. 1 A is a perspective side view of an exemplary prosthetic valve that includes three rungs of angled struts.

[0079] Fig. IB is a side view of the frame of the prosthetic valve of Fig. 1 A.

[0080] Fig. 1C shows a flattened view of the frame of Fig. IB.

[0081] Figs. 2A and 2B are side views of the frame of Fig. IB in a radially crimped state and a radially expanded state, respectively.

[0082] Fig. 3 shows a flattened view of an exemplary leaflet.

[0083] Fig. 4A is a side view of an exemplary frame that includes four rungs of angled struts.

[0084] Fig. 4B shows a flattened view of the frame of Fig. 4A.

[0085] Fig. 5 shows an exemplary delivery apparatus carrying an exemplary prosthetic valve.

[0086] Fig. 6 shows one third of an exemplary prosthetic valve defining a minimal axial distance between the free edge of the leaflet and the outflow end of the frame.

[0087] Fig. 7 A illustrates an exemplary positioning of a prosthetic valve in an aortic valve, relative to a coronary artery, where the prosthetic valve at least partially inhibits blood flow to the coronary artery.

[0088] Fig. 7B illustrates an exemplary positioning of a prosthetic valve in an aortic valve, relative to a coronary artery, where the prosthetic valve is spaced farther from the coronary artery relative to its position in Fig. 7A.

[0089] Fig. 8 is a side view of an exemplary frame of a prosthetic valve having axial segments thereof wrapped by covering elements.

[0090] Fig. 9 is a side view of an exemplary frame of a prosthetic valve having angled struts thereof wrapped by covering elements.

[0091] Fig. 10 is a side view of an exemplary frame having vertices thereof comprising arcuate regions.

[0092] Fig. 11A is a cross-sectional view of an aortic valve illustrating a first positioning of a prosthetic valve within the aortic valve where commissures of the prosthetic valve at least partially block one or more coronary ostia.

[0093] Fig. 1 IB is a cross-sectional view of an aortic valve illustrating a second positioning of a prosthetic valve within the aortic valve where commissures of the prosthetic valve are circumferentially aligned with native commissure of the aortic valve, thereby maintaining access to the coronary arteries.

[0094] Fig. 12 shows a portion of an exemplary prosthetic valve that includes a top marker having an enlarged head portion.

[0095] Fig. 13 shows a portion of an exemplary prosthetic valve that includes a cap covering a head portion of a top marker thereof.

[0096] Fig. 14 shows a portion of an exemplary prosthetic valve that includes a top marker having an elongated neck portion.

[0097] Fig. 15 shows the top marker of Fig. 14 in a bent state when pressed against the sinus ceiling.

[0098] Fig. 16 shows a portion of an exemplary prosthetic valve that includes a top marker having a serpentine-shaped neck portion.

[0099] Fig. 17 A shows a portion of an exemplary frame having a widened axial segment on one side of a commissure support segment.

[0100] Fig. 17B shows a portion of an exemplary frame having an axial segment that including a bulging widened portion on one side of a commissure support segment.

[0101] Fig. 18A shows a portion of an exemplary frame having an enlarged joint on one side of a commissure support axial member.

[0102] Fig. 18B shows the exemplary frame of Fig. 18A further defining an aperture extending through the enlarged joint.

[0103] Fig. 19 shows a portion of an exemplary frame having an enlarged outflow apex on one side of a commissure support axial member.

[0104] Fig. 20 shows a portion of an exemplary prosthetic valve having a radiopaque marker attached to a commissure thereof.

[0105] Fig. 21 A is a perspective side view of an exemplary prosthetic valve having an outflow rung flipped relative to the outflow rung of the prosthetic valve of Fig. 1 A.

[0106] Fig. 21B is a perspective side view of the prosthetic valve of Fig. 21 A, having outflow apices thereof comprising arcuate regions.

[0107] Fig. 22 is a perspective side view of an exemplary prosthetic valve having both the outflow rung and the intermediate rung flipped relative to the same rungs of the prosthetic valve of Fig. 1A.

[0108] Fig. 23A is a perspective view of an exemplary frame having an intermediate cell row comprising diamond-shaped cells.

[0109] Fig. 23B shows a portion of the frame of Fig. 23 A.

[0110] Fig. 24A shows a portion of an exemplary frame having an intermediate rung flipped relative to the intermediate rung of the prosthetic valve of Fig. 1 A.

[0111] Fig. 24B shows a portion of the frame of Fig. 24A further comprising vertical stabilization stmts axially extending between vertices of the inflow rung and the intermediate rung.

[0112] Fig. 25A shows a portion of an exemplary frame having an outflow rung and an intermediate rang axially spaced from each other to a greater distance relative to their positions shown in the frame of Fig. 1 A.

[0113] Fig. 25B shows a portion of the frame of Fig. 25A further comprising vertical stabilization struts axially extending between vertices of the outflow rung and the intermediate rung.

[0114] Fig. 26 shows a portion of an exemplary prosthetic valve having an inflow rung that include a downwardly-oriented pair of struts between neighboring upwardly -oriented pairs of struts on both sides thereof.DETAILED DESCRIPTION

[0115] For purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present, or problems be solved. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope of the disclosed technology.

[0116] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0117] All features described herein are independent of one another and, except where structurally impossible, can be used in combination with any other feature described herein.

[0118] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the terms "have" or "includes" means "comprises". Further, the terms "coupled", "connected", and "attached", as used herein, are interchangeable and generally mean physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, "and / or" means "and" or "or", as well as "and" and "or".

[0119] Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as "inner," "outer," "upper," "lower," "inside," "outside,", "top," "bottom," "interior," "exterior," "left," right," and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an "upper" part can become a "lower" part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same.

[0120] The term "plurality" or "plural" when used together with an element means two or more of the element. Directions and other relative references (e.g., inner and outer, upper and lower, above and below, left and right, and proximal and distal) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting.

[0121] The terms "proximal" and "distal" are defined relative to the use position of a delivery apparatus. In general, the end of the delivery apparatus closest to the user of the apparatus is the proximal end, and the end of the delivery apparatus farthest from the user (e.g., the end that is inserted into a patient’s body) is the distal end. The term "proximal" when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the proximal end of the delivery apparatus. The term "distal" when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the distal end of the delivery apparatus. The terms "longitudinal" and "axial" are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0122] Throughout the figures of the drawings, different superscripts for the same reference numerals are used to denote different examples of the same elements. Examples of the disclosed devices and systems may include any combination of different examples of the same elements. Specifically, any reference to an element without a superscript may refer to anyalternative example of the same element denoted with a superscript. In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component.

[0123] Figs. 1A and IB show perspective and side views, respectively, of an example of a prosthetic valve 10, with and without soft components (such as skirts and a leaflet assembly). The term "prosthetic valve", as used herein, refers to any type of a prosthetic valve deliverable to a patient's target site over a catheter, which is radially expandable and compressible between a radially compressed, or crimped, state, and a radially expanded state. Thus, the prosthetic valve can optionally be crimped on or retained by an implant delivery apparatus 52 (see Fig. 5) in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site. The expanded state may include a range of diameters to which the valve may expand, between the compressed state and a maximal diameter reached at a fully expanded state. Thus, a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state.

[0124] A prosthetic valve of the current disclosure (e.g., prosthetic valve 10, 100) may include any prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve. The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve), or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0125] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Patent No. 10,363,130, which is incorporated by reference herein. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in US Publication No. 2022 / 0079749, which is incorporated herein by reference. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava forreplacing the function of a diseased tricuspid valve, such as disclosed in U.S. Patent No. 11,291,540, which is incorporated herein by reference.

[0126] It is to be understood that any prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses. Balloon expandable valves generally involve a procedure of inflating a balloon within a prosthetic valve, thereby expanding the prosthetic valve within the desired implantation site. Once the valve is sufficiently expanded, the balloon is deflated and retrieved along with a delivery apparatus 52 (see Fig. 5). Self-expandable valves include a frame that is shape-set to automatically expand as soon an outer retaining shaft or capsule (not shown) is withdrawn proximally relative to the prosthetic valve. Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion. The mechanical actuation mechanism usually includes a plurality of expansion and locking assemblies (such as the prosthetic valves described in U.S. Patent No. 10,603,165, International Application No. PCT / US2021 / 052745, and U.S. Provisional Application Nos. 63 / 085,947 and 63 / 209904, each of which is incorporated herein by reference in its entirety), releasably coupled to respective actuation assemblies of a delivery apparatus, controlled via a handle (not shown) for actuating the expansion and locking assemblies to expand the prosthetic valve to a desired diameter. The expansion and locking assemblies may optionally lock the valve's diameter to prevent undesired recompression thereof, and disconnection of the actuation assemblies from the expansion and locking assemblies, to enable retrieval of the delivery apparatus once the prosthetic valve is properly positioned at the desired site of implantation.

[0127] The prosthetic valve 10 comprises a frame 106 movable between a radially compressed state and a radially expanded state, and a valvular structure 170 mounted within the frame 106. The frame extends between an inflow end 104 and an outflow end 102, and defines a central longitudinal axis CA extending in a direction from the inflow end 104 to the outflow end 102. In some instances, the inflow end 104 is the distal end of the frame 106, and the outflow end 102 is the proximal end of the frame 106. Alternatively, depending for example on the delivery approach of the valve, the inflow end can be the proximal end of the frame, and the outflow end can be the distal end of the frame.

[0128] The term "proximal", as used herein, generally refers to a position, direction, or portion of a device or a component of a device, which is closer to the user (for example, during an implantation procedure) and further away from the implantation site.

[0129] The term "distal", as used herein, generally refers to a position, direction, or portion of a device or a component of a device, which is further away from the user and closer to the implantation site.

[0130] The term "outflow", as used herein, refers to a region of the prosthetic valve through which the blood flows through and out of the prosthetic valve.

[0131] The term "inflow", as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve.

[0132] In the context of the present application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow", respectively. Thus, for example, the lower end of the prosthetic valve is its inflow end and the upper end of the prosthetic valve is its outflow end.

[0133] The terms "longitudinal" and "axial", as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0134] Fig. 1C shows the frame 106 in a flat configuration for purposes of illustration. The frame 106 can be made of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol). When constructed of a plastically- expandable material, the frame 106 (and thus the valve 10, 100) can be crimped to a radially compressed state on a delivery catheter (e.g., balloon catheter 60 shown in Fig. 5) and then expanded inside a patient by an inflatable balloon (e.g., balloon 62 shown in Fig. 5) or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 106 (and thus the valve 10, 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0135] Suitable plastically-expandable materials that can optionally be used to form the frames disclosed herein (e.g., the frame 106) include metal alloys, polymers, or combinations thereof. Example metal alloys can optionally comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, rhenium, or other biocompatible metal. In some examples, the frame 106 comprises stainless steel. In some examples, the frame 106 comprises cobaltchromium. In some examples, the frame 106 comprises nickel-cobalt-chromium. In some examples, the frame 106 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight. In some examples, the frame 106 comprises a refractorymetal alloy. In some examples, the frame 106 comprises a metal alloy that includes at least 20% atomic weight of at least one of: MoRe alloy, ReW alloy, MoReCr alloy, MoReTa alloy, MoReTi alloy, WCu alloy, ReCr, molybdenum alloy, rhenium alloy, tungsten alloy, tantalum alloy, niobium alloy, or any combination thereof. In some examples, the frame 106 comprises a metal allow that includes at least 20 atomic weight percentage of rhenium.

[0136] In the example illustrated in Figs. 1A-1C, the frame 106 is an annular, stent-like structure comprising a plurality of intersecting struts 108 which form multiple rows 130 of cells 128 between the outflow end 102 and the inflow end 104 of the frame 106. In this application, the term "stmt" 108 encompasses vertical stmts, angled or curved stmts, support posts, commissure windows, and any similar structures described by U.S. Pat. Nos. 7,993,394 and 9,393,110, which are incorporated herein by reference. A stmt 108 may be any elongated member or portion of the frame 106. The frame 106 can include a plurality of stmt rungs 114 that can collectively define a plurality of cells 128 arranged in several cell rows 130. The frame 106 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 104 to the outflow end 102 as shown, or the frame can vary in diameter along the height of the frame, as disclosed in US Pat. No. 9,155,619, which is incorporated herein by reference.

[0137] Figs. 1A-1C show an exemplary prosthetic valve 10 that can be representative of, but is not limited to, a balloon expandable prosthetic valve. The interconnected stmts 108 include a plurality of angled stmts 110 arranged in a plurality circumferentially extending mngs 114 of angled stmts, with the stmt mngs 114 being arrayed along the length of the frame 106 between the outflow end 102 and the inflow end 104. Stmts 108 of the frame 106 can optionally further include a plurality of axial frame members 116 angularly spaced apart from each other around the circumference of the frame. The term "axial frame member" refers to a stmt or a component of the frame 106 that generally extends in an axial direction (parallel to the central longitudinal axis CA), while the term "angled stmt" generally refers to a stmt that can extend at an angle relative to an axial line intersecting therewith along a plane defined by the frame 106. It is to be understood that the term "angled stmt" encompasses both linear angled stmts and curved stmts, including, in some examples, stmts that can have one or more undulations along their lengths.

[0138] The angled stmts 110 in each mng 114 are arranged is stmt pairs 112, wherein each pair 112 fomrs a V shape between adjacent axial frame members 116. The angled stmts 110 of each pair 112 intersect with each other at a vertex 134, which is illustrated in Figs. 1A-1C in the form of a generally U-shaped stmcture, though any other suitable shape of the vertex iscontemplated. Opposite to the vertex 134, each angled strut 110 is connected to the corresponding axial frame member 116 at a joint 132. Thus, each pair 112 of struts is connected by two joints 132 to the corresponding two axial frame members 116. The terms "pair", "strut pair", and "pair of struts", as used throughout the description and the claims, are interchangeable.

[0139] The frame 106 further defines a plurality of outflow apices 136 at the outflow end 102 of the frame, and a plurality of inflow apices 138 at the inflow end 104 of the frame. The angled stmts 1 10 may be pivotable or bendable relative to each other, to the central longitudinal axis CA, and / or relative to the axial frame members 116, so as to permit frame expansion or compression. For example, the frame 106 can be optionally formed from a single piece of material, such as a metal tube, via various processes such as, but not limited to, laser cutting, electroforming, and / or physical vapor deposition, while retaining the ability to collapse / expand radially in the absence of hinges and like.

[0140] Any frame disclosed herein can include at least three stmt mngs, namely an outflow mng 1140 of outflow angled stmts 110O at the outflow end 102 of the frame, an inflow mng 1141 of outflow angled stmts 1101 at the inflow end 104 of the frame, and at least one intermediate rang 114S therebetween. Any frame disclosed herein can include at least two cell rows 130, namely an outflow cell row 1300 of outflow cells 1280 at the outflow end 102 of the frame, and an inflow cell row 1301 of inflow cells 1281 at the inflow end 104 of the frame. Optionally, but not necessarily, one or more intermediate cells rows 130S can be further defined between the outflow cell row 1300 and the inflow cell row 1301.

[0141] Various exemplary implementations for prosthetic valve 100 and / or components thereof can be referred to, throughout the specification, with superscripts, for ease of explanation of features that refer to such exemplary implementations. It is to be understood, however, that any reference to structural or functional features of any device, apparatus or component, without a superscript, refers to these features being commonly shared by all specific exemplary implementations that can be also indicated by superscripts. In contrast, features emphasized with respect to an exemplary implementation of any device, apparatus or component, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary implementations. For example, a prosthetic valve 10a, illustrated in Figs. 1A-1C, is an exemplary implementation of a prosthetic valve 10, and thus can include any of the features described for a prosthetic valve 10 throughout the current disclosure, except that the frame 106a of the prosthetic valve 10a comprises exactly three stmt mngs 114 that define exactly two cell rows 130 therebetween. Namely, frame 106a is shown to include a singleintermediate rung 114S comprising a plurality of intermediate struts 1101, and no intermediate cell rows between the outflow cell row 1300 and inflow cell row 1301. It is to be understood that a frame 106 can optionally include less or more than three rungs.

[0142] The valvular structure 170 can comprise a plurality of leaflets 172 (e.g., three leaflets), positioned at least partially within the frame 106, and configured to regulate flow of blood through the prosthetic valve 10 from the inflow end 104 to the outflow end 102. While three leaflets 172 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Fig. 1 A, it will be clear that a prosthetic valve 10 can include any other number of leaflets 172. Adjacent leaflets 172 can be arranged together to form commissures 184 that are coupled (directly or indirectly) to respective portions of the frame 106, thereby securing at least a portion of the valvular structure 170 to the frame 106.

[0143] The frame 106 includes an outflow cell row 1300, an inflow cell row 1301, and optionally (but not necessarily) one or more intermediate cell rows 130S therebetween. Each cell row 130 comprises a plurality of cells 128 extending circumferentially such that each cell 128 is directly coupled to two circumferentially adjacent cells 128 on both sides thereof within the same row of cells. The term "cell", as used herein, refers to a closed cell, having an enclosed perimeter defined by at least four struts 108. In the example illustrated in Figs. 1A-1C, the frame 106a is shown to include exactly two cell rows 130, namely the outflow cell row 1300 and the inflow cell row 1301, without any intermediate cell rows therebetween.

[0144] In some examples, such as shown in Figs. 1A-1C, each cell row 130 comprises nine cells 128. Thus, the frame 106 can be referred to as a nine-cell frame. In other examples, the frame 106 can have a greater or fewer number of circumferentially extending cell rows 130 and / or a greater or fewer number of cells 128 in each cell row.

[0145] In some examples, cells 128 are coupled to adjacent cells 128 within the same row via axial frame members 116. Each axial frame member 116 can be comprised of axial segment 118, wherein an axial segment 118 of an axial frame member 116 is defined as a portion of the corresponding axial frame member 116 extending between axially-adjacent joints 132 of the same axial frame member 116. Thus, the number of segments 118 of each axial frame member 116 can match the number of cell rows 130 of the frame. In the example illustrated in Figs. 1A- 1C, adjacent inflow cells 1281 share common inflow axial segments 1181, and adjacent outflow cells 1280 share common outflow axial segments 1180.

[0146] Axial frame members 116 include, in some examples, commissure support axial members 122 and non-commissural axial members 120. A commissure support axial member 122 has one of its axial segments 118 defined as a commissure support segment 124, configuredto support a corresponding commissure 184 of the valvular structure 170. In contrast, a non- commissural axial members 120 can be defined such that non of its axial segments 118 is a commissure support segment. The axial frame members 116, including non-commissural axial members 120 and commissure support axial members 122, can optionally be parallel to each other and / or to the central longitudinal axis CA of the frame 106.

[0147] In some examples, commissure support segments 124 are outflow axial segments 1180, wherein each pair of immediately adjacent commissure support segments 124 can be separated by one or more outflow axial segments 1 180 of non-commissural axial members 1 120 disposed therebetween.

[0148] In some examples, a commissure support segment 124 can optionally comprise a commissure window opening 126 defined between two axially-extending sidewalls. While commissure support segments 124 that include commissure window openings 126 are illustrated and described herein, it is to be understood that a frame 106 can include other types of commissure support segments configured to mount a commissure 184 in any other suitable manner, such as by supporting portions of the valvular structure 170 that can be wrapped therearound, can include apertures through which sutures for attaching the commissures can be passed, and the like.

[0149] While the width of most of the axial segments 118 is shown in Figs. 1A-1C to be substantially similar to that of the angled struts WS, it is to be understood that in some examples, at least some axial frame members 116 or axial segments 118 thereof can have a width WA that is larger than a width WS of at least some of the angled struts 110. As used herein, a "width" of a strut is measured between opposing locations on opposing surfaces of a strut that extend between the radially facing inner and outer surfaces of the stmt (relative to the central axis CA). A "thickness" of a stmt is measured between opposing locations on the radially facing inner and outer surfaces of a stmt and is perpendicular to the width of the stmt. In some examples, a width of the commissure support segment 124 can be greater than that of other axial segments, for example due to inclusion of a commissure window opening 126 formed therein.

[0150] The V-shaped configuration of the stmt pairs 112 can be oriented either towards the inflow end (i.e., the direction oriented from the outflow end to the inflow end) or towards the outflow end (i.e., the direction oriented from the inflow end to the outflow end). In some examples, as shown for frame 106a in Fig. 1A-1C, all stmt pairs 112 of the same mng 114 are oriented in the same direction. Stated otherwise, a stmt pair 112 is termed to be oriented toward the inflow end when its vertex 134 is closer to the inflow end 104 while its two joints 132 arecloser to the outflow end 102. Similarly, a stmt pair 112 is termed to be oriented toward the outflow end when its vertex 134 is closer to the outflow end 102 while its two joints 132 are closer to the inflow end 104. In the example illustrated in Figs. 1A-1C, all stmt pairs 112 of the outflow rung 1140 are oriented towards the inflow end, while all stmt pairs 1 12 of the inflow mng 1141 are oriented towards the outflow end.

[0151] In the example shown for frame 106a in Figs. 1A-1C, all stmt pairs 112 of the single intermediate rang 114S are further shown to be oriented towards the inflow end, such that the outflow mng 1 140 and the intermediate mng 1 14S are substantially parallel to each other.

[0152] Each outflow cell 1280 is defined between a pair of outflow angled stmts 1120, a pair of intermediate angled stmts 112S, and two outflow axial segments 1180 extending between the two pairs of angled stmts. Each inflow cell 1281 is defined between a pair of inflow angled stmts 1121, a pair of intermediate angled stmts 112S, and two inflow axial segments 1181 extending between the two pairs of angled stmts.

[0153] As mentioned above, while two rows 130 of cells 128 defined between three rungs 114 of angled stmts 110 are illustrated, it is to be understood that any exemplary prosthetic valve disclosed herein can include any other number of cell rows 130 and stmt rungs 114.

[0154] In some examples, the prosthetic valve 10 can optionally include at least one skirt 190 disposed around the frame 106. In some examples, the at least one skirt 190 can include an inner skirt secured to an inner surface of the frame 106. The inner skirt can function as a sealing member to prevent or decrease perivalvular leakage, to anchor the valvular stmcture 170 to the frame 106, and / or to protect the leaflets 172 against damage caused by contact with the frame 106 during crimping and during working cycles of the prosthetic valve 10. In some examples, cusp end portions 178 of the leaflets 172 can be sutured to the inner skirt generally along a scallop-shaped line. The inner skirt can in turn be coupled to the frame 106 by one or more fasteners, such as sutures. In some examples, an inner skirt comprises a single sheet of material that extends continuously around frame 106. In some examples, the inner skirt can optionally comprise one or more skirt portions that are connected together and / or individually connected to the frame 106.

[0155] Due to the orientation of the stmt pairs 112 along the inflow mng 1141 and the outflow mng 1140, the outflow apices 136 are defined at the upper joints 132 of the axial frame members 116 with the outflow mng of stmts 1140, and the inflow apices 138 are defined at the lower joints 132 of the axial frame members 116 with the inflow mng of stmts 1141.

[0156] In some examples, the inflow axial segments 1181 are longer than the outflow axial segments 1 180, as shown for exemplary prosthetic valve 10a in Figs. 1A-1C. When the stmtpairs 112 of the inflow rung 1141 and the outflow rung are oriented towards each other, the inflow axial segments 1181 can be designed to be long enough to prevent these rungs from crossing each other in the compressed or expanded states of the frame. In contrast, the parallel orientation of the outflow rung 1140 and the intermediate rung 114S allow for a relatively shorter length of the outflow axial segments 1180, thereby enabling, in some examples, formation of an overall shorter prosthetic valve 10 if desired.

[0157] Figs. 2A and 2B are side views of the frame 106a of Figs. 1A-1C, in a radially crimped state and in a radially expanded state, respectively. As shown, the height of the frame, defined as the axial distance between the inflow end 104 and outflow end 102 of the frame 106, does not change between the compressed and expanded state of the frame. Specifically, a frame configuration in which the strut pairs 112 of the outflow rung 1140 are oriented towards the inflow end 104, and the strut pairs 112 of the inflow rung 1141 are oriented towards the outflow end 102, such that all vertices 134 of any strut pairs 112 are disposed between both ends of the frame at all times, can result in no foreshortening during expansion from the compressed state.

[0158] As the frame of such a configuration moves from the radially compressed state shown in Fig. 2A, to the radially expanded state shown in Fig. 2B, the circumferential distance between adjacent axial frame members 116 increases due to pivoting or angular movement of the angled stmt 110. However, since the inflow end 104 and outflow end 102 coincide with the ends of the axial frame members 116, which do not change orientation during frame compression or expansion, the frame's height remains unchanged and equal to the length of the axial frame members 1 16, thereby substantially eliminating valve foreshortening. Stated otherwise, when the upper and lower ends of the axial frame members 116, at which the axial frame members 116 intersect with the outflow rung of angled stmts 1140 and the inflow mng of angled stmts 1141, define the outflow apices 136 and the inflow apices 138, respectively, the height (or axial length) of the frame 106 is substantially equal to the unchanging length of the axial frame members 116, irrespective of the state or diameter of the prosthetic valve. This can facilitate more accurate and / or predictable deployment of the prosthetic valve from the radially compressed state.

[0159] In some examples, the frame 106 can further include one or more top markers 146 extending proximally from the outflow end 102 of the frame. For example, a top marker 146 can be generally continuous with a corresponding axial frame member 116 from which it extends. A top marker is configured to serve as an indicator of the angular orientation of the frame 106, and can have various suitable shapes and dimensions. For example, the top marker 146 illustrated for exemplary frame 106a is shown to be flag-shaped, including a neck portionextending substantially in an axial direction from the outflow end 102 of the frame, and terminating with a head portion 150 that extends in a lateral or circumferential direction, substantially perpendicularly to the neck portion 148. It is to be understood that any reference to an outflow end 102 of a frame 106a as shown in Figs. 1 A-2B, for example, refers to an end defined at the level of the outflow apices 136, such that the top markers 146 can be termed to extend past the level of the outflow end 102. Likewise, any reference herein to a height (or axial length) of a frame 106, refers to a distance between the inflow end 104 and the outflow end 102, without accounting for top markers 146 considered to extend pas the outflow end 102.

[0160] In some examples, the at least one skirt 190 can include an outer skirt disposed around an outer surface of the frame 106, and configure to function, for example, as a sealing member retained between the frame 106 and the surrounding tissue of the native annulus against which the prosthetic valve is mounted, thereby reducing risk of paravalvular leakage (PVL) past the prosthetic valve 10. In some examples, the outer skirt comprises a single sheet of material that extends continuously around the frame 106. In some examples, the outer skirt can optionally comprise one or more skirt portions that are connected together and / or individually connected to the frame 106.

[0161] Any of an inner skirt and / or outer skirt can optionally comprise various suitable biocompatible materials, such as, but not limited to, natural tissue (e.g. pericardial tissue), a fabric, or polymeric material (such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc.).

[0162] It is to be understood that an inner skirt and an outer skirt are described herein by way of illustration and not limitation. For example, a prosthetic valve 10 can optionally be provided with an inner skirt and without an outer skirt, in which case, the inner skirt further serves as a PVL sealing member of the valve against the surrounding anatomy. Similarly, a prosthetic valve 10 can optionally be provided with an outer skirt (such as skirt 190 illustrated in Fig. 1 A) and without an inner skirt, in which case, the leaflet's cusp end portion 178 can be optionally directly coupled (e.g., sutured) to stmts 108 of the frame 106.

[0163] Fig. 3 shows a flattened view of an exemplary leaflet 172. In some examples, each leaflet 172 can optionally comprise opposing commissure attachment members, which can be optionally in the form of tabs 176 as shown, for example, in Fig. 3. Optionally, each tab 176 can be secured to an adjacent tab 176 of an adjacent leaflet 172 to form a commissure 184 that is secured to the frame 106.

[0164] Each leaflet 172 further defines a free edge 180 on a portion of the leaflet 172 between the two tabs 176 and closest to the outflow end 102 of the frame 106, and a cusp end portion 178 extending between the two tabs 176 opposite to the free edge 180. In some examples, thecusp end portion 178 can optionally define a single scallop having a midpoint 182 that can be the lowermost or distal-most point of the leaflet 172. A central axis CL of the leaflet 172, extending through the midpoint 182, can similarly bisect the free edge 180, wherein the medial free edge portion 181 can be defined as a portion of the free edge 180 extending from the central axis of the leaflet CL towards both side of the leaflet (e.g., towards both tabs 176), wherein the lateral length LL of the medial free edge portion 181 can be defined as a percentage portion of the total length of the free edge 180. For example, a length of the free edge 180 can be defined, in the lateral direction (e.g., when the leaflet is in a spread flat configuration as illustrated in Fig. 3), as the distance between the opposing tabs 176, while the lateral length LL of the medial free edge portion 181 can be defined to be at least 75% of this total free edge length.

[0165] The leaflets 172 can optionally define a non-planar coaptation plane (not annotated) when the free edge portions of the leaflets coapt or mate with each other to seal blood flow through the prosthetic valve 10. During diastole, the adjacent free edge portions should coapt with each other to prevent retrograde blood from flowing between the free edge portions. During systole, the adjacent free edge portions will separate from each other and allow antegrade blood to flow between free edge portions.

[0166] The leaflets 172 can optionally be made from, in whole or part, biological material (e.g., pericardium), bio-compatible synthetic materials, or other such materials. Further details regarding transcatheter prosthetic heart valves, including the manner in which the valvular structure 170 can be coupled to the frame 106 of the prosthetic valve 10, can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,652,202, and 11,135,056, all of which are incorporated herein by reference in their entireties.

[0167] Figs. 4 A and 4B show perspective and flattened views of a frame 106b of exemplary prosthetic valve 10b, illustrated without soft components such as leaflets or skirts for simplicity. Prosthetic valve 10b can be structurally and functionally similar to any example of prosthetic valve 10 described herein, except that the frame 106b of prosthetic valve 10b includes two intermediate rungs 114S of angled struts, namely a first intermediate rung 114S1 of first intermediate angled struts 110S 1 distal to the outflow rung 1140, and a second intermediate rung 114S2 of second intermediate angled struts 11 OS 2 distal to the first intermediate rung 114S1 and proximal to the inflow rung 1141. Thus, frame 106b defines a single intermediate cell row 130S between the outflow cell row 1300 and the inflow cell row 1301.

[0168] All strut pairs 112 of the outflow rung 1140 and all strut pairs 112 of the first intermediate rung 114S 1 are oriented towards the inflow end, such that the outflow rung 1140 and the first intermediate rung 114S 1 are substantially parallel to each other. All strut pairs 112 of the inflow rung 1141 and all strut pairs 112 of the second intermediate rung 114S2 are oriented towards the outflow end, such that the inflow rung 1141 and the second intermediate rung 114S2 are substantially parallel to each other.

[0169] Each outflow cell 1280 of frame 106b is defined between a pair of outflow angled struts 1 120, a pair of first intermediate angled stmts 1 12S1 , and two outflow axial segments 1180 extending between the two pairs of angled stmts. Each inflow cell 1281 of frame 106b is defined between a pair of inflow angled stmts 1121, a pair of second intermediate angled stmts 112S2, and two inflow axial segments 1181 extending between the two pairs of angled stmts. Each intermediate cell 128S of frame 106b is defined between a pair of first intermediate angled stmts 112S1, a pair of second intermediate angled stmts 112S2, and two intermediate axial segments 118S extending between the two pairs of angled stmts.

[0170] Fig. 5 shows an exemplary delivery assembly 50 that includes a delivery apparatus 52 adapted to deliver a prosthetic device, which can be any exemplary prosthetic valve 10 described above, or any exemplary prosthetic valve 100 described below with respect to Figs. 6-26. The delivery apparatus 52 can optionally include a handle 54 and at least one catheter extending therefrom, configured to carry a prosthetic valve 10, 100 in a radially compressed state through the patient's vasculature. An exemplary delivery assembly 50 comprises an exemplary delivery apparatus 52 configured to carry a balloon expandable prosthetic valve. The delivery apparatus 52 can optionally comprise a balloon catheter 60 having an inflatable balloon 62 mounted on its distal end. A prosthetic device, such as prosthetic valve 10, 100, can be optionally carried in a crimped state over the balloon catheter 60.

[0171] In some examples, a delivery apparatus 52 further comprises an outer shaft 58. Optionally, an outer shaft 58 of a delivery apparatus 52 can concentrically extend over the balloon catheter 60.

[0172] The outer shaft 58 and the balloon catheter 60 can optionally be configured to be axially movable relative to each other. For example, a proximally oriented movement of the outer shaft 58 relative to the balloon catheter 60, or a distally oriented movement of the balloon catheter 60 relative to the outer shaft 58, can expose the prosthetic valve 10, 100 from the outer shaft 58.

[0173] A delivery apparatus 52 can optionally further include a nosecone 64 to facilitate advancement of the delivery apparatus 52 through the patient's vasculature to the site oftreatment. A nosecone shaft (concealed from view in Fig. 5) can optionally extend proximally from the nosecone 64 through a lumen of the balloon catheter 60, towards the handle 54.

[0174] In Fig. 5, a prosthetic valve 10, 100 is mounted on the balloon 62 and is shown in a crimped state, providing prosthetic valve 10, 100 with a reduced diameter for delivery to the heart via the patient's vasculature. While the prosthetic valve 10, 100 is shown in Fig. 5 as being crimped or mounted on the balloon 62 for delivery to the treatment location, it should be understood that the prosthetic valve can be optionally crimped or mounted at a location different from the location of balloon 62 (e.g., proximal to the balloon 62) and repositioned over the balloon at some time before inflating the balloon and deploying the prosthetic valve. This off-balloon delivery allows the prosthetic valve to be crimped to a lower profile than would be possible if the prosthetic valve was crimped on top of the balloon 62. The lower profile permits the clinician to more easily navigate the delivery apparatus (including the crimped prosthetic valve) through a patient's vasculature to the treatment location. The lower profile of the crimped prosthetic valve can be particularly helpful when navigating through portions of the patient's vasculature which are particularly narrow, such as the iliac artery.

[0175] The proximal ends of the balloon catheter 60, the outer shaft 58, and / or the nosecone shaft, can optionally be coupled to the handle 54. During delivery, the handle 54 can be maneuvered by an operator (e.g., a clinician or a surgeon) to axially advance or retract components of the delivery apparatus 52, such as the nosecone shaft, the outer shaft 58, and / or the balloon catheter 60, through the patient's vasculature and / or along the target site of implantation, as well as to inflate the balloon 62 mounted on the balloon catheter 60, for example to expand a prosthetic valve 10, 100 mounted on the balloon 62, and to deflate the balloon 62 and retract the delivery apparatus 52, for example once the prosthetic valve 10, 100 is mounted in the implantation site.

[0176] The handle 54 can optionally include a steering mechanism configured to adjust the curvature of a distal end portion of the delivery apparatus 52. In the illustrated example, the handle 54 includes an adjustment member, such as the illustrated rotatable knob 56a, which in turn is operatively coupled to the proximal end portion of a pull wire (not shown). The pull wire can optionally extend distally from the handle 54 through the outer shaft 58 and has a distal end portion affixed to the outer shaft 58 at or near the distal end of the outer shaft 58. Rotating the knob 56a can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 52. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Pat. No. 9,339,384, which is incorporated by reference herein.

[0177] In some examples, the handle 54 can include an adjustment member such as the illustrated rotatable knob 56b, configured to adjust the axial position of the balloon catheter 60 relative to the outer shaft 58, for example for fine positioning at the implantation site. The handle can include additional knobs to control additional components of the delivery apparatus 52. Further details on the delivery apparatus 52 can be found in PCT Application No. PCT / US2021 / 047056, which is incorporated by reference herein.

[0178] A prosthetic valve 10, 100 can be carried by the delivery apparatus 52 during delivery in a crimped state, and expanded, for example by balloon inflation, to secure it in a native heart valve annulus (such as an aortic annulus) or against a previously implanted prosthetic valve (for example, during valve -in-valve implantation procedures). In some examples, the balloon 62 is secured to a distal end portion of the balloon catheter 60 at its proximal end, while the balloon's distal end can optionally be coupled, directly or indirectly, to another component of the delivery apparatus 52, such as the nosecone 64 or nosecone shaft.

[0179] Balloon 62 is configured to transition between a deflated and inflated states. Upon reaching the site of implantation, the balloon 62 can be inflated to radially expand the prosthetic valve 10, 100. Once the prosthetic valve 10, 100 is expanded to its functional diameter within a native annulus, the balloon 62 can be deflated, and the delivery apparatus 52 can be retrieved from the patient's body.

[0180] In some examples, the delivery apparatus 52 with the prosthetic valve 10, 100 assembled thereon, can be packaged in a sterile package that can be supplied to end users for storage and eventual use. In some examples, when the leaflets of the prosthetic valve are made from, or include at least an inner core made from, bovine pericardium tissue or other natural or synthetic tissues, the leaflets can be treated during the manufacturing process so that they are completely or substantially dehydrated and can be stored in a partially or fully crimped state without a hydrating fluid. In this manner, the package containing the prosthetic valve and the delivery apparatus, can be free of any liquid. Methods for treating tissue leaflets for dry storage are disclosed in U.S. Pat. Nos. 8,007,992 and 8,357,387, both of which documents are incorporated herein by reference.

[0181] Described herein are examples of prosthetic valves 100 that can be structurally and functionally similar to any exemplary prosthetic valve 10 described above, except where indicated otherwise.

[0182] Fig. 6 shows one third of an exemplary prosthetic valve 100c, which is an exemplary implementation of a prosthetic valve 10, 100, and thus can include any of the features described for a prosthetic valve 10 or 100 throughout the current disclosure, except that a minimal axialdistance SU is defined between the free edge 180 of the leaflet 172c and the outflow end 102 of the frame 106c of prosthetic valve 100c.

[0183] In some instances, after a prosthetic valve 10, 100 has been implanted it may become necessary to access the coronary artery 36 (shown in Figs. 7A-7B for example). Thus, it may be necessary to preserve coronary access either through or above the frame of a prosthetic valve 10, 100. This access can be affected by the positioning of the free edges 180 of the leaflets 172.

[0184] Lowering the free edges 180 of the leaflet 172 enlarges the space available above the level of the free edges 180, such as a space defined between the free edges 180 and a sinus ceiling 32 when implanted, as described in greater detail below with respect to Fig. 7B, through which a catheter or other surgical implement can be passed.

[0185] In some examples, this can be accomplished by forming the leaflet 172c to have a shape and dimensions that will result in the desired distancing of the free edge 180 from the outflow end 102 when the leaflet 172c is coupled to the frame 106. For example, when formed of a tissue, such as pericardium, the leaflet can be cut from a tissue patch according to the desired shape and dimensions. In another example, when the leaflet is formed of a synthetic material, formation of the leaflet can include appropriate procedures by which the desired shape and dimensions can be achieved, including (but not limited to) molding, 3D injection, cutting, heat shaping (for example, in the case of leaflets formed from thermoplastic polymers), and the like.

[0186] In some examples, a leaflet 172c can have tabs 176 terminating, at upper ends of the tabs, at a higher level than that of the free edge 180, which can be also referred to a s a "high- tab" configuration. Tabs 176 of adjacent leaflets 172c can be coupled together to form a commissure 184, which can be coupled to the frame 106 at a commissure support segment 124, optionally passed through a commissure window opening 126 which is lower than (or distal to) the outflow end 102. In the case of a high-tab leaflet 172c, the free edge 180 which is even lower than the commissures 184, can be therefore axially offset from the outflow end 102 by a distance that can be equal to or greater than the desired minimal axial distance SU.

[0187] In some examples, the free edge 180 can be relatively straight in a spread flat configuration of the leaflet (as shown for example in Fig. 3), such as by being substantially perpendicular to the central axis of the leaflet CL. In some examples, the free edge 180 can have a curved or non-linear configuration. Any example of a prosthetic valve 100c referred to as having the free edge 180 being offset by a minimal axial distance SU from the outflow end 102, can similarly refer to a medial free edge portion 181, extending over a lateral length LL, being offset by a minimal distance SU from the outflow end 102. In some examples, the lateral length LL is equal to or greater than 50% of the total length of the free edge 180. In someexamples, the lateral length LL is equal to or greater than 60% of the total length of the free edge 180. In some examples, the lateral length LL is equal to or greater than 70% of the total length of the free edge 180. In some examples, the lateral length LL is equal to or greater than 75% of the total length of the free edge 180. In some examples, the lateral length LL is equal to or greater than 80% of the total length of the free edge 180.

[0188] In some examples, a delivery apparatus 52 (or another, similar delivery apparatus) can be configured to deploy and implant a prosthetic valve 10, 100 within the aortic root 22 of the aorta. As shown in Figs. 7A-7B, the aortic root 22 of the aorta is defined between the native aortic annulus 24 and the sinotubular junction (STJ) 34 (the junction between the sinus 30 and the ascending aorta 20). Branching off the aortic root 22 are the coronary arteries 36 (e.g., the left coronary artery and the right coronary artery). The coronary artery ostia 38 are the openings that connect the aortic root 22 to the coronary arteries 36. The coronary arteries 36 carry oxygenated blood from the aorta to the muscle of the heart.

[0189] Depending on a patient’s anatomy, the prosthetic valve may cover (e.g., be placed in front of) at least a portion of a coronary ostium 38, as shown in the example depicted in Fig. 7A. The interference with blood flow to the coronary arteries 36 can be further exacerbated when a leaflet 172 of the prosthetic valve is arranged in front of (e.g., adjacent to) a coronary ostium 38 of one of the coronary arteries 36. For example, a prosthetic valve can be deployed within the aortic root 22 such that the outflow end 102 is at or adjacent to the sinus ceiling 32, below the STJ 34.

[0190] Such positioning of the prosthetic valve can result in one or more leaflets 172 of the prosthetic valve causing coronary artery obstruction. However, if a prosthetic valve 100c, having a free edge 180 of the leaflet sufficiently distanced from the outflow end 102, as described above with respect to Fig. 6, is implanted, as shown in Fig. 7 A, sufficient space can be advantageously provided between the leaflet 172c (or free edge 180 thereof) and a ceiling 32 of the sinus 30 to allow for adequate coronary perfusion and coronary access. In some examples, the minimal axial distance SU and / or the lateral length LL of a medial free edge portion 181 can be at least as great as the diameter of a selected coronary catheter. For example, for a typical 6 Fr coronary catheter, any of the minimal axial distance SU and / or the lateral length LL can be equal to or greater than 2 mm. For instances in which the outflow end 102 of the prosthetic valve is distanced from the native anatomy, for example forming a gap of 0.5 mm or more therebetween, the minimal axial distance SU can be equal to or greater than 1.5 mm.

[0191] In some examples, as shown in Fig. 7B, the outflow end 102 of a prosthetic valve is not necessarily in close proximity to, or in direct contact with, the sinus ceiling 32, such that during diastole, blood can flow from the aorta over top of the outflow end 102 of the prosthetic valve, which can be any valve 10, 100 disclosed herein, or can be a prosthetic valve 100c that offsets the free edges 180 of the leaflets even farther from the surrounding anatomical walls, to ensure adequate space not only for coronary perfusion but for passing a catheter or tool therethrough if required.

[0192] The leaflets 172 of the valvular structure 170 constantly transition between a fully-open state, allowing blood flow through the valve, and a closed state, wherein the leaflets co-apt so as to prevent blood backflow. As such, the movable portions of the leaflets 172 can repetitively hit, when opened, against the frame 106, which may cause leaflet abrasion resulting in a reduction in durability and / or increased wear on the leaflet. Various portions of the frame 106 that can be contacted by the moving portions of the leaflets 172, can be covered and / or coated so as to reduce the risk abrasive damage to the leaflets.

[0193] Fig. 8 is a side view of an exemplary prosthetic valve lOOd, shown without leaflets or skirts for simplicity. Prosthetic valve lOOd is an exemplary implementation of prosthetic valve 100, and thus can include any of the features described for prosthetic valve 100 throughout the current disclosure, except that one or more of the axial segments 118 of prosthetic valve lOOd is covered by a covering element 164. In some examples, one or more of the outflow axial segments 1180 is covered by a covering element 164. In some examples, all of the outflow axial segments 1180 of non-commissural axial members 120 are covered by covering elements 164. While only outflow axial segments 1180 of non-commissural axial members 120 are shown in Fig. 8 to be covered, it is to be understood that other axial segment 118 can be fully or at least partially covered. For example, at least a portion of one or more of the inflow axial segments 1181 can be similarly covered by one or more covering element(s) 164.

[0194] Fig. 9 is a side view of an exemplary prosthetic valve lOOe, shown without leaflets or skirts for simplicity. Prosthetic valve lOOe is an exemplary implementation of prosthetic valve 100, and thus can include any of the features described for prosthetic valve 100 throughout the current disclosure, except that one or more of the angled struts 110 of prosthetic valve lOOe is covered by a covering element 164. In some examples, one or more of the outflow angled stmts 110O is covered by a covering element 164. In some examples, all of the outflow angled stmts 110O are covered by covering elements 164. While only angled stmts 110 of the outflow mng 1140 are shown in Fig. 9 to be covered, it is to be understood that angled stmts of other mngs,such as an intermediate rung 114S, can be similarly covered by one or more covering element(s) 164.

[0195] In some examples, a covering element 164 can comprise a relatively smooth strip or band of material that can cover and / or be looped or wrapped around at least a portion of an axial segment 118 and / or an angled stmt 110. In some examples, a covering element 164 can comprise a fabric or polymeric strip or band of material. In some examples, a covering element 164 can comprise a tissue strip. In some examples, the covering element 164 can be looped or wrapped around at least a portion of corresponding axial segments 1 18 and / or corresponding angled stmts 110. In some examples, multiple covering elements 164, that can be provided as multiple strips of material, can be used to cover corresponding portions of the frame 106, such as axial segment(s) 118 and / or angled stmt(s) 110.

[0196] In some examples, a tissue-based covering member can comprise pericardium or intestinal submucosa. In some examples, covering element 164 can comprise a coating layer that can applied to the one or more axial segment 118 and / or angled stmts 110 by a coating technique selected from, but not limited to, electrospinning, brushing, spray-coating, dip coating, combinations thereof, or any other suitable coating technique.

[0197] In some examples, covering element 164 can comprise at least one material selected from a polycarbonate, a polyamide, a polyester, polytetrafluoroethylene (PTFE), ePTFE, UHMWPE, a polyolefin, a polyether, a polyurethane, and combinations and copolymers thereof. In some examples, covering element 164 can comprise a thermoplastic material such as, but not limited to, thermoplastic polyurethane (TPU), styrene block copolymers (TPS), thermoplastic polyolefinelastomers (TPO), thermoplastic vulcanizates (TPV), thermoplastic copolyester (TPC), thermoplastic polyamides (TP A), and combinations and variations thereof.

[0198] In some examples, one or more of the vertices 134 of a frame 106 is covered by a covering element 164. In some examples, at least the vertices 134 of the outflow rung 1140 are covered by covering elements 164. Nevertheless, vertices 134 of any other rung 114, such as an intermediate rung 110S or inflow rung 1101, can be covered by covering elements 164. In some examples, covering elements 164 can be continuously looped over angled stmts 110 and vertices 134 defined thereby.

[0199] Fig. 10 is a side view of an exemplary prosthetic valve lOOf, shown without leaflets or skirts for simplicity. Prosthetic valve lOOf is an exemplary implementation of prosthetic valve 100, and thus can include any of the features described for prosthetic valve 100 throughout the current disclosure, except that at least some vertices 134 frame 106f, such as vertices 134 of the outflow rung 1140, comprise arcuate regions 140 defined between upper curved surfaces142 axially facing the outflow end 102 and lower curved surfaces 144 axially facing the inflow end 104. In some examples, the arcuate regions 140 of vertices 134 are thinner than the remainder of the corresponding angled struts 110 diverging therefrom.

[0200] The term "width", as used herein with respect to a strut or a vertex, refers to a dimension of a strut or an arcuate region of a vertex measured between opposing locations on opposing surfaces of the strut or vertex that extend between the radially facing inner and outer surfaces of the strut or apex (relative to the central longitudinal axis Ca), respectively. For example, an arcuate region 140 has a width WV defined between its upper 142 and lower 144 curved surfaces, which is less than a width WS of a stmt continuously extending therefrom. The arcuate region 140 can have a uniform width WV along a length LV, which can be in the range of 10%-25% of a length LS of a corresponding angled stmt 110 diverging therefrom, as shown in Fig. 10, wherein the length LS is inclusive of half the arcuate region 140.

[0201] In the example illustrated in Fig. 10, each vertex 134 of the outflow mng 1140 comprises a downwardly convex-shaped lower curved surface 144 and an opposing upper curved surface 142 that can form an inner depression of the vertex 134. In some cases, vertices 134 of the outflow mng 1140 can interact with the leaflets of the prosthetic valve. For example, when the leaflets are secured to the frame, the vertices 134 can be disposed at a level (or axial height) of a portion of the leaflets that open and close during operation of the prosthetic valve.

[0202] Thus, in some instances, when the leaflets are in an open state when implanted in a patient, the leaflets can contact the vertices 134. In such cases, it is beneficial for the corresponding vertices to have an arcuate regions with curved outer surfaces, as illustrated in Fig. 10. The curved outer surface is more atraumatic and may not interfere with the leaflets of the prosthetic valve as the leaflets open and close during operation of the prosthetic valve. Thus, long term durability of the leaflets can be increased.

[0203] While only the vertices 134 along the outflow mng 1140 are shown in Fig. 10 to have arcuate regions 140, with vertices 134 along other mngs, such as the intermediate mng 114S and the inflow mng 1141 shown to be in the form of "pointed" apices which are devoid of arcuate regions, it is to be understood that in some examples, any group of vertices 134 along any mng of stmts can be similarly shaped. For example, each vertex 134 of a mng that includes pairs of stmts 112 oriented towards the inflow end, such as along an intermediate mng 114S, can comprise a downwardly convex-shaped lower curved surface 144 and an opposing upper curved surface 142 that can form an inner depression of the vertex 134. Similarly, each vertex 134 of a mng that includes pairs of stmts 112 oriented towards the outflow end, such as alongthe inflow rung 1141, can comprise an upwardly convex-shaped upper curved surface 142 and an opposing lower curved surface 144 that can form an inner depression of the vertex 134.

[0204] In some examples, the arcuate region 140 of a vertex 134 of a pair of struts 112 oriented towards the inflow end 104 can have a radius of curvature along the lower curved surface 144, and the arcuate region 140 of a vertex 134 of a pair of struts 112 oriented towards the outflow end 102 can have a radius of curvature along the upper curved surface 142. In some examples, the radius of curvature of arcuate region 140 can be greater than 1 mm. In some examples, the radius of curvature of arcuate region 140 can be in a range of 1 -20 mm, 3-16 mm, or 8-14 mm. In some examples, the radius of curvature of arcuate region 140 can be greater than 10 mm. Additional details and examples of frames for prosthetic valves that include apices with arcuate regions can be found in PCT Application No. PCT / US2022 / 025687, which is incorporated by reference herein.

[0205] As mentioned above with respect to Fig. 7A, during implantation, a prosthetic valve may cover (e.g., be placed in front of) at least a portion of the ostium 38 of one of the coronary arteries 36. The interference with blood flow to the coronary arteries 36 can be further exacerbated when a commissure 184 of the prosthetic valve 10, 100 is arranged in front of (e.g., adjacent to) an ostium 38 one of the coronary arteries 36. For example, since adjacent leaflets are coupled together at the commissures 184, the commissures 184 can form bulky structures that block and / or reduce blood flow towards the coronary ostia 38. Thus, less oxygenated blood flow can reach the coronary arteries and the heart muscle.

[0206] Thus, instead of deploying the prosthetic valve with the delivery apparatus in a random rotational orientation relative to the aorta, which may result in commissures 184 of the prosthetic valve 10, 100 being arranged in front of the coronary ostia 38 (as shown in Fig. HA), it may be desirable to deploy the prosthetic valve 10, 100 in an targeted rotational orientation where the commissures 184 are positioned away from and do not block the coronary arteries 36 (as shown in Fig. 1 IB). For example, as shown in Fig. 1 IB, the delivery apparatus can be configured to deploy the prosthetic valve 10, 100 such that commissures 184 of the radially expanded prosthetic valve 10, 100 are circumferentially aligned with the native commissures 28 of the aortic valve.

[0207] Thus, it may be desirable to implant a prosthetic valve in a native valve such that commissures of the prosthetic valve are aligned with commissures of the native valve. In some examples, in order to facilitate the desired rotational positioning of the prosthetic valve relative to the native valve, the prosthetic valve can include a feature which is visible under medicalimaging, configured to indicate a location of a selected commissure of the prosthetic valve relative to the native valve (or alternate native anatomy) during the implantation procedure.

[0208] In some examples, a frame of the prosthetic valve can include a directional marker that can be identified under medical imaging, such as fluoroscopy. For example, prosthetic valve 10 is shown in Figs. 1A-4B to include a top marker 146 configured to allow a clinician to correctly interpret the circumferential orientation of the prosthetic valve and to align the commissures 184 of the prosthetic valve with the native commissure 28 to reduce risk of blocking coronary access. A directional marker, such as top marker 146, may be identified under fluoroscopy simply by virtue of its distinct shape.

[0209] Any directional marker disclosed herein can optionally be formed as an integral part of the frame 106, which can be formed from a radiopaque material such as metal. In some examples, a directional marker can be provided as a separate component which is affixed to the frame, and can be made from the same material as the frame or from any other suitable radiopaque material. In some examples, a directional marker can include a radiopaque coating to enhance visibility thereof under fluoroscopy. In some examples, a directional marker can include a radiopaque component attached thereto.

[0210] In the examples illustrated in Figs. 1 A-4B, a top marker 146 extends from a commissure support axial member 122, and has an asymmetric shape, formed by a head portion 150 that extends at a lateral direction from a neck portion. Because such an asymmetric shape, such as flag-shape of top marker 146, looks different when viewed from a front view as compared to when viewed from a rear view, the clinician can determine whether a particular portion of the frame 106, a commissure support axial member 122, etc., is facing toward or away from the viewing direction.

[0211] Since the optimal circumferential orientation of the prosthetic valve relative to the coronary arteries can be verified prior to deflating the balloon 62 over which the prosthetic valve is expanded, the clinician can ensure that the prosthetic valve is properly oriented in the native anatomy so as to avoid risk of blocking coronary access. While a flag-shaped or P- shaped directional marker is illustrated in Figs. 1 A-4B, it is to be understood that a directional marker can be otherwise formed to have any shape which is asymmetric relative to an axial direction thereof, such as by being formed in the shape of any letter, number, symbol or shape that looks different when viewed from a front view compared to the rear view.

[0212] In some cases, the prosthetic valve 10, 100 can be deployed in the native anatomy such that the outflow end 102 is in close proximity to the sinus wall at the STJ 34, as illustrated for example in Fig. 7B. In some instances, during deployment of the prosthetic valve, the topmarkers 146 can come into contact and be pressed against the sinus ceiling 32. Since a top marker 146 of the type illustrated in Figs. 1A-4B can be relatively sharp due to the small-size of its head portion 150, and can be relatively rigid due to the short length of its neck portion 148, the top marker 146 may pose a risk of tissue damage when pressed thereagainst.

[0213] Fig. 12 shows a portion of an exemplary prosthetic valve 100g having a top marker 146g extending from a commissure support axial member 122 thereof. Prosthetic valve 100g is an exemplary implementation of prosthetic valve 100, and thus can include any of the features described for prosthetic valve 100 throughout the current disclosure, including a top marker as described above with respect to exemplary prosthetic valve 10, except that the head portion 150g of top marker 146g is larger than the head portion 150 illustrated for prosthetic valve 10 in Figs. 1A-4B. A lateral length LH can be defined for the head portion 150g as a length thereof in a direction perpendicular to the axial direction. The lateral length LH of the head portion 150g can be selected to form an atraumatic edge thereof, large enough so as to avoid penetrating or otherwise damaging native tissue against which it can be pressed, such as the sinus ceiling 32. In some examples, the lateral length LH is greater than 1 mm. In some examples, the lateral length LH is greater than 1.5 mm. In some examples, the lateral length LH is greater than 2 mm.

[0214] In some examples, enlargement of the head portion 150 can be achieved by thickening it in the radial direction, instead of or in additional to elongating it in the lateral direction. In some examples, the thickness of a head portion 150 can be greater than the thickness of the remainder of the frame 106.

[0215] In some examples, head portion 150 of top marker 146 can be covered by a covering element 164 which can be implemented according to any example described above for covering elements 164 wrapped or otherwise covering axial segments 118, angled struts 110, or vertices 134.

[0216] Fig. 13 shows a portion of an exemplary prosthetic valve lOOh having a top marker 146 extending from a commissure support axial member 122 thereof. Prosthetic valve lOOh is an exemplary implementation of prosthetic valve 100, and thus can include any of the features described for prosthetic valve 100 throughout the current disclosure, including a top marker 146 that can be implemented according to any example disclosed herein, except that the head portion 150 of top marker 146 is covered by a covering element 164. In some examples, a covering element 164h can include a cap 166. A cap 166 can include a main body that defines an inner pocket 168 sized and shaped to fit around the corresponding head portion 150. In some examples, the cap 166 can be shaped and sized to define an atraumatic end that encapsulatedthe head portion 150. In some examples, the cap 166 can be dimensioned to enlarge surface area that may contact tissue engaged thereby.

[0217] While a covering element 164 in the form of a cap 166 is shown in Fig. 13 to cover a head portion 150 of a top marker 146, in some examples, similar caps 166 can be used as a cover element 164 that cover vertices 134 of the frame 106.

[0218] In some examples, an outer surface 167 of the cap 166 can be curved, such as by being substantially spherical or semi-spherical in shape. The curvature of the outer surface 167 can provide an atraumatic surface.

[0219] In some examples, the outer surface of the cap 166 can be a smooth low-friction surface, to avoid damaging tissue contacted thereby. In some examples, the cap can be coated by a lubricious and / or low-friction material. Appropriate lubricious and / or low-friction material can include, but are not limited to, Teflon, parylene, PTFE, polyethylene, poly vinylidene fluoride, and combinations thereof. In some examples, the covering external surface 316 has a coefficient of friction of 0.1 or less.

[0220] Surface roughness is a component of surface texture. It is quantified by the deviations in the direction of the normal vector of a real surface from its ideal form. If these deviations are large, the surface is considered rough, and if they are small, the surface is considered smooth. Therefore, the term "smooth", as used herein refers to a surface having minor deviations in the direction of the normal vector of a real surface from its ideal form. Smooth surfaces are substantially unitary / continuous surfaces, free from irregular voids. The term "smooth" is not intended to be limited to the narrow meaning of a substantially planar surface devoid of surface irregularities.

[0221] Surface roughness is typically calculated by a method termed "Ra" or roughness average, which represents the arithmetic average of a set of individual measurements of surfaces peaks and valleys (e.g., normal vectors), relative to a mean line (e.g., a real surface), wherein low Ra values represents smooth surfaces.

[0222] In some examples, an outer surface of any covering elements 164 disclosed herein, including covering elements 164 implemented as tapes or ribbons of material that can be wrapped around axial segment 118, angled struts 110, vertices 134 and / or head portions 150 of top markers 146, as well as covering elements 164 that may be implemented as caps 166, can be optionally characterized by having a Ra value of about 0.2 pm or less, which corresponds to a roughness grade number of N4 (for example, as indicated by ISO 1302: 1992). In some examples, the Ra value of an outer surface of any covering element disclosed hereinis below about 0.2 jam. In some examples, an outer surface of any covering element disclosed herein is characterized by having a smooth surface having a Ra value of about 0.2 pm or less.

[0223] In some examples, a top marker 146 can be configured to be relatively flexible or easily bendable such that when pressed against an anatomical wall tissue, such as the sinus ceiling, the top marker 146 may bend without exerting significant force against the tissue. This can be accomplished, in some examples, by modifying the neck portion 148 to be flexible enough to flex and / or bend when the head portion 150 is pressed against the tissue.

[0224] Fig. 14 shows a portion of an exemplary prosthetic valve 1 OOi having a top marker 146i extending from a commissure support axial member 122 thereof. Prosthetic valve lOOi is an exemplary implementation of prosthetic valve 100, and thus can include any of the features described for prosthetic valve 100 throughout the current disclosure, including a top marker 146 that can be implemented according to any example disclosed herein, except that the neck portion 148i of top marker 146i is longer that the neck portion 148 illustrated for prosthetic valve 10 in Figs. 1A-4B. An axial length LN can be defined for the neck portion 148i, optionally selected to be long enough to bend when the top marker 146i is pressed against the sinus ceiling 32, as shown in Fig. 15 for example. In some examples, the axial length LN is greater than 2 mm. In some examples, the axial length LN is greater than 3 mm. In some examples, the axial length LN is greater than 4 mm. In some examples, the length to width ratio of the neck portion 148i is greater than 3. In some examples, the length to width ratio of the neck portion 148i is greater than 4.

[0225] Fig. 16 shows a portion of an exemplary prosthetic valve lOOj having a top marker 146j extending from a commissure support axial member 122 thereof. Prosthetic valve lOOj is an exemplary implementation of prosthetic valve 100, and thus can include any of the features described for prosthetic valve 100 throughout the current disclosure, including a top marker 146 that can be implemented according to any example disclosed herein, except that the neck portion 148j of top marker 146j has a non-linear configuration configured to facilitate bending thereof when the top marker 146j is pressed against the sinus ceiling 32. For example, the neck portion 148j can be serpentine-shaped, though other non-linear configuration are contemplated, such as being C-shape, S-shaped, having a meandering configuration, and the like.

[0226] In some examples, the prosthetic valve can non-symmetric with respect to opposite sides of a commissure support axial member 122. For example, one or more features, visible under medical imaging (such as fluoroscopy), present next to one side of the commissure support axial member 122, can be differently shaped relative to the same feature(s) on the opposite side. Such a differently-shaped feature can be optionally identified under fluoroscopyby virtue of its distinct shape, and in some examples, can further be coated by a radiopaque coating, or include a radiopaque component attached thereto, to enhance visibility thereof. The commissure support segment 124 of a commissure support axial member 122 can be identified, in some examples, due to the window opening 126 formed therein.

[0227] A portion of the frame that includes the differently-shaped feature, which can be any of: an angled strut 110, an axial segment 118, a joint 132 and / or a vertex 134, will be viewed on different sides of the commissure support axial member 122 (or commissure support segment 124 thereof) when viewed from a front view as compared to when viewed from a rear view, such that a clinician can determine whether a particular portion of the frame 106, including the commissure support axial member 122, etc., is facing toward or away from the viewing direction.

[0228] Fig. 17A shows a portion of a frame 106k of an exemplary prosthetic valve 100k. Prosthetic valve 100k is an exemplary implementation of prosthetic valve 100, and thus can include any of the features described for prosthetic valve 100 throughout the current disclosure, except that the frame 106kincludes an axial segment 118 having a widened portion 154 on one side of the commissure support axial member 122, while the axial segment 118 (at the same axial level) on the other side of the commissure support axial member 122 does not include a similar widened portion. The term "immediately adjacent" refers to circumferentially adjacent axial frame members 116 that do not include another axial frame member 116 disposed therebetween. A widened portion 154 can define a maximal width WW.

[0229] The portion of frame 106k shown in Fig. 17A illustrates a commissure support axial member 122 having a first immediately adjacent non-commissural axial member 120a on one side thereof, and a second immediately adjacent non-commissural axial member 120b on the other side. The first non-commissural axial member 120a is shown to include a widened portion 154k extending along most of the length of its outflow axial segment 1180, having a substantially uniform width WW that is greater than the width WA of the outflow axial segment 1180 of the second non-commissural axial member 120b. The term "substantially uniform width", as used herein with respect to an axial segment, refers to a width which is uniform along at least 75% of the length of the axial segment.

[0230] Fig. 17B shows a portion of a frame 1061 of an exemplary prosthetic valve 1001. Prosthetic valve 1001 is similar to any example described herein for prosthetic valve 100k, except that the widened portion 1541 of frame 1061 is shown to define a circular bulge formed along the outflow axial segment 1180 of the first immediately adjacent non-commissural axial member 120a. In some examples, the widened portion 1541 can be shaped like a ring ordoughnut or torus, optionally defining an aperture 156 extending therethrough. In some examples, a radiopaque component can be attached to the widened portion 1541. In some examples, a radiopaque component can be optionally placed inside the aperture 156.

[0231] While the widened portion 1541 is illustrated to be in the form of a circularly-shaped bulge in Fig. 17B, it is to be understood that in some examples, widened portion 1541 can have any other shape bulging from the corresponding axial segment 118, such as elliptic, triangular, rectangular, 8 -shaped, and the like.

[0232] While the outflow axial segment 1 180 of a first non-commissural axial member 120a is shown to include a widened portion 154 in Figs. 17 A and 17B, it is to be understood that any other axial segment of the first non-commissural axial member 120a, such as an inflow axial segment 1181 thereof, can similarly include a widened portion 154. While the first non- commissural axial member 120a is shown to include a widened portion 154 formed along one axial segment 118 thereof, such as the outflow axial segment 1180 in Figs. 17A and 17B, it is to be understood that more than one axial segment 118, and optionally all of the axial segment 118 of the first non-commissural axial member 120a, can include widened portion(s) 154. For example, a first non-commissural axial member 120a can be formed to have a substantially uniform width WW of a widened portion 154k extending along its entire length. Similarly, bulging widened portions 1541, which can be similarly or differently shaped from each other, can be formed along some or all axial segments 118 of a first non-commissural axial member 120a.

[0233] While widened portions 154 are shown in Figs. 17A-17B to be formed along non- commissural axial frame members 120, it is to be understood that any type of widened portion 154 disclosed herein can be similarly formed along angled struts 110. Thus, in some examples, one or two angled struts 110 of at least one pair 112 extending between a commissure support axial member 122 and an immediately-adjacent first non-commissural axial member 120a, can include a widened portion 154, while angled stmts 110 disposed between the commissure support axial member 122 and an immediately-adjacent second non-commissural axial member 120b remain regularly sized, having a stmt width WS smaller than the width WW defined by the widened portion 154.

[0234] Fig. 18A shows a portion of a frame 106m of an exemplary prosthetic valve 100m. Prosthetic valve 100m is an exemplary implementation of prosthetic valve 100, and thus can include any of the features described for prosthetic valve 100 throughout the current disclosure, except that a first non-commissural axial member 120a of the frame 106m includes an enlarged joint 158, while the second non-commissural axial member 120b includes a regularly-size joint132 (at the same axial level). In the example illustrated in Fig. 18A, an enlarged joint 158m is shown to be defined at the intersection between the first non-commissural axial member 120a and the intermediate rung of angled struts 114S.

[0235] Fig. 18B shows a portion of a frame 106n of an exemplary prosthetic valve lOOn. Prosthetic valve lOOn is similar to any example described herein for prosthetic valve 100m, except that the enlarged joint 158n of frame 106n is shown to further define an aperture 160 extending therethrough. In some examples, a radiopaque component can be attached to the enlarged joint 158. In some examples, a radiopaque component can be optionally placed inside the aperture 160 of an enlarged joint 158n.

[0236] Fig. 19 shows a portion of a frame 106o of an exemplary prosthetic valve lOOo. Prosthetic valve lOOo is similar to any example described herein for prosthetic valve 100m or lOOn, except that the enlarged joint 158o is defined at an outflow apex 136 of the frame 106o. While the enlarged joint 158o is shown in Fig. 19 to include an aperture extending therethrough in a manner similar to that of enlarged joint 158n, it is to be understood that in some examples, an enlarged joint or apex 158o can be devoid of an aperture, as illustrated for example for 158m in Fig. 18 A.

[0237] While an enlarged joint 158 formed at an intersection between the first non- commissural axial member 120a and the intermediate rung 114S is shown in Figs. 18A-18B, or with the outflow rung 1140 is shown in Fig. 19, it is to be understood that an enlarged junction can be formed at an intersection between the first non-commissural axial member 120a and any other rung of angled struts, such as the inflow rung 1141 (in which case it will be defined as an enlarged inflow apex). While an enlarged joint 158 is shown to be formed at an intersection between the first non-commissural axial member 120a and a single one of the stmt rungs 114 in Figs. 18A-19, it is to be understood that in some examples, a plurality of enlarged joints 158 can be defined at several axial levels of the first non-commissural axial member 120a, and optionally at the intersection of the first non-commissural axial member 120a with all rungs 114.

[0238] While enlarged joints 158 formed along a first non-commissural axial member 120a are shown in Figs . 18 A- 19, it is to be understood that enlarged vertices 134 can be similarly formed at stmt pairs 112 extending from one side of a commissure support axial member 122. Thus, in some examples, one or two pairs of stmts 112 extending between a commissure support axial member 122 and an immediately-adjacent first non-commissural axial member 120a can define an enlarged vertex that is larger in size than a vertex defined by stmt pairs 112 extending between the commissure support axial member 122 and an immediately-adjacent second non-commissural axial member 120b. An enlarged vertex can be similar to any example described herein for enlarged joints 158, mutatis mutandis, and can either include or be devoid of an aperture extending therethrough.

[0239] As mentioned above, a portion of the frame 106 that includes a widened portion 154, an enlarged joint 158, and / or an enlarged vertex, optionally implemented according to any of the examples disclosed herein to be on one side of a corresponding commissure support axial member 122 but not the other, will appear on different sides of the commissure support axial member 122 when viewed from a front view as compared to when viewed from a rear view, such that a clinician can determine whether a particular portion of the frame 106, including the commissure support axial member 122, etc., is facing toward or away from the viewing direction.

[0240] Fig. 20 shows an exemplary prosthetic valve lOOp. Prosthetic valve lOOp is an exemplary implementation of prosthetic valve 100, and thus can include any of the features described for prosthetic valve 100 throughout the current disclosure, except that prosthetic valve lOOp further includes a radiopaque marker 162 attached to a commissure 184 thereof.

[0241] A commissure 183 can comprise two tabs 176 of adjacent leaflets 172 paired with each other. During assembly of the prosthetic valve, the pair of tabs 176 of the two adjacent leaflets 172 can then be inserted through a commissure window opening 126. As a result, the tabs 176 extend through the commissure window opening 126 and are arranged exterior to the frame 106 (extending radially outward from an outer surface of the frame 106). The tabs 176 forming the commissure 184 can then be secured to the commissure support segment 124, on an outside of the frame 106. In some examples, one or more pieces of fabric or wedge members can be used to cover and / or secure a portion of the commissure 184 to the commissure support segment 124.

[0242] In some examples, as shown in Fig. 20, a radiopaque marker 162 can be attached (e.g., sutured) to an outer surface (a radially outward facing surface) of the commissure 184 such that the radiopaque marker 162 is exposed. In some examples, a piece of fabric or other flexible member can be secured to the commissure 184 and cover all or a portion of the radiopaque marker 162.

[0243] While only one radiopaque marker 162 is visible in Fig. 20, it should be noted that one or more of the commissures 184 can include a radiopaque marker attached thereto. For example, in some cases, a radiopaque marker can be secured to each commissure 184 of the prosthetic valve lOOp (e.g., the prosthetic valve lOOp can include three radiopaque markers:one for each commissure). In some examples, a radiopaque marker 162 may only be attached to one or two of the commissures 184.

[0244] In some examples, the radiopaque marker 162 and the other radiopaque components described herein can comprise a radiopaque material, such as one or more of: tantalum, iodine, barium, barium sulfate, tantalum, bismuth, or gold.

[0245] In some examples, the radiopaque marker 162 can be an asymmetric marker that allows a clinician to differentiate between two different positions of the marker 162 within the imaging view. For example, the asymmetric marker 162 can be configured such that a clinician viewing the imaging view can differentiate between the marker being positioned in a front or a back of the fluoroscopic imaging view.

[0246] In some examples, the asymmetric radiopaque marker 162 can be a letter of the alphabet (such as a C-shaped marker shown in Fig. 20), a number, a symbol, a shape, or the like, that is reflection asymmetric along an axis that is parallel to the central longitudinal axis CA. For example, an asymmetric marker can have a first orientation where it can be read "correctly" or forward (e.g., not backward) and a second orientation that is approximately 180 degrees rotated around the axis from the first orientation, which results in the marker appearing backward to a reader (e.g., clinician).

[0247] Fig. 21 A shows an exemplary prosthetic valve lOOq. Prosthetic valve lOOq is an exemplary implementation of prosthetic valve 100, and thus can include any of the features described for prosthetic valve 100 throughout the current disclosure, except that the strut pairs 112 of the outflow rung 1140 of prosthetic valve lOOq are oriented towards the outflow end, opposite to the intermediate rung 114S having strut pairs 112 oriented towards the inflow end. Thus, the vertices 134 of the outflow rung 1140 form the outflow apices 136 of frame 106q.

[0248] While the joints 132 of the outflow rung 1140 and the intermediate rung 114S immediately distal thereto, can be at the same axial levels (or equally distanced from each other in the axial direction) for exemplary prosthetic valves lOOq and 10a, flipping the orientation of the outflow rung 1140 of frame 106q, relative to the orientation shown in Figs. 1A-1C for exemplary frame 106a, serves to increase the axial distance between the vertices 134 of the outflow rung 1140 and the intermediate rung 114S for frame 106q, relative to the axial distanced between the vertices of the same mngs for the frame 106a, for example. This results in outflow cells 1280 which are larger (or longer in the axial direction) for the frame 106q, relative to the outflow cells 1280 of the frame 106a for example.

[0249] As discussed with respect to Fig. 7 A, some prosthetic valves may have an overall height (or axial length), in their expanded state, that can place the outflow cell row 1300 at the levelof the coronary ostia 38. For example, such valves 100 can be designed to have their outflow apices 136 contacting or being placed in the vicinity of the sinuses 30 or the STJ 34 when expanded at the site of implantation. As further mentioned above, in some instances, a patient may require implantation of a coronary stent or other procedure that requires access to a coronary artery after prosthetic valve implantation. For such instances, a physician may need to access the coronary artery through the opening defined by an outflow cell 1280 of the outflow cell row 1300 facing the coronary ostium.

[0250] Cells 1280 along the outflow cell row 1300 of prosthetic valve lOOq can have an axial length (defined between vertices 134 of the cells) greater than that of other cell rows 130, such as the inflow cell row 1301, or an intermediate cell row 130S if the prosthetic valve lOOq includes two intermediate rungs of angled struts 114S1, 114S2 as described with respect to exemplary valve 10b for example. The increased size of the outflow cells 1280 can advantageously provide a larger opening for blood flow and / or coronary access.

[0251] Fig. 21B shows an exemplary prosthetic valve lOOr. Prosthetic valve lOOr is similar to any example described herein for prosthetic valve lOOq, except that the outflow apices 136 of prosthetic valve lOOr comprise arcuate regions 140 defined between upper and lower curved surfaces, in a similar manner to that described above with respect to prosthetic valve lOOf of Fig. 10. Each outflow apex 136 of prosthetic valve lOOr is shown to include an arcuate apex region 140 defined between an upwardly convex-shaped upper curved surface 142 and an opposing lower curved surface 144 that can form an inner depression of the outflow apex 136.

[0252] Assuming that the length of the axial frame members 116 of exemplary prosthetic valve lOOq or lOOr is substantially similar to their length in exemplary prosthetic valves 10a or 10b, for example, the overall height (or axial length) of the frame can be increased for prosthetic valve lOOq or lOOr due to the flipped outflow rung 1140, offsetting the outflow end 102 of the frame farther from the outflow end of the axial frame members 116. Longer valves can lead to conduction disturbances due to the risk of the outflow portion positioned high enough (for example, above the STJ level) so as to interfere with coronary flow and access. Formation of the outflow apices 136 of prosthetic valve lOOr to include arcuate apex regions 140 instead of having upwardly-oriented U-shaped apex portions shown for prosthetic valve lOOq, for example, may shorten the overall length of the frame. Moreover, the arcuate apex regions 140 of the outflow apices 136 can be more atraumatic to reduce risk of damage inflicted by the outflow apices 136 when pressed against an anatomical wall tissue.

[0253] Fig. 22 shows an exemplary prosthetic valve 100s. Prosthetic valve 100s is similar to any example described herein for prosthetic valves lOOq or lOOr, except that the intermediaterung 114S of prosthetic valve 100s is also flipped such that the strut pairs 112 of the intermediate rung 114S of prosthetic valve 100s are oriented towards the outflow end, parallel to the outflow rung 1140.

[0254] The joints 132 of the outflow rung 1140, the intermediate rung 114S immediately distal thereto, and the inflow rung 1141 can be at the same axial levels (or equally distanced from each other in the axial direction) for exemplary prosthetic valves 100s and 10a, such that flipping the orientation of the intermediate rung 114S of frame 106s, relative to the orientation shown in Figs. 1 A-l C for exemplary frame 106a, serves to increase the axial distance between the vertices 134 of the intermediate rung 114S and the inflow rung 1141 for frame 106s, relative to the axial distanced between the vertices of the same rungs for the frame 106a, for example. The skirt 190 can extend from the inflow end 104 to the intermediate rung 114S, optionally having an outflow end of the skirt that generally tracks the zig-zagged shape of the intermediate rung 114S to which it is coupled (for example, by being sutured thereto, or using any other form of couplers). This results in an overall higher skirt 190 which can provide a higher sealing length between the prosthetic valve and the surrounding anatomy.

[0255] The flipped orientation of the outflow rung 1140 of prosthetic valve 100s, in a similar manner to that discussed above with respect to prosthetic valve lOOq for example, can advantageously allow sufficient room for the flipping of the intermediate rung 114S, such that the axial distance between the vertices 134 of the outflow rung 1140 and the intermediate rung 114S is substantially similar to that shown for the oppositely oriented rungs 1140, 114S of prosthetic valve 10a, for example, without posing a risk of struts of the flipped intermediate rung 114S crossing the outflow rang 1140.

[0256] In some examples, vertices 134 of the outflow rang 1140 (which are also outflow apices 136) and / or the intermediate rang 114S can comprise arcuate regions 140, as described above with respect to prosthetic valves lOOr and lOOf, for example.

[0257] Fig. 23A is a perspective view of a frame 106t exemplary prosthetic valve lOOt. Fig. 23B shows a flattened side view of the frame 106t of Fig. 23 A. Prosthetic valve 100m is an exemplary implementation of prosthetic valve 100, and thus can include any of the features described for prosthetic valve 100 throughout the current disclosure, except that it includes an intermediate cell row 130S of diamond-shaped cells 128S.

[0258] Similar to the exemplary frame 106b described above with respect to Figs.4A-4B, the frame 106t is shown to include a total of four rungs of angled struts, wherein all strut pairs 112 of the outflow rang 1140 are oriented towards the inflow end and all strut pairs 112 of the inflow rang 1141 are oriented towards the outflow end. However, in contrast to exemplaryframe 106b, all strut pairs 112 of the first intermediate rung 114S1 are oriented towards the outflow end and all strut pairs 112 of the second intermediate rung 114S2 are oriented towards the inflow end. The first and intermediate rungs 114S1 and 114S2 can further intersect at mutual joints 132 with the corresponding axial frame member 116, resulting in generally rhombus-shaped or diamond-shaped intermediate cells 128S, wherein each intermediate cell 128S is defined between a pair of first intermediate angled struts 112S1 and a pair of second intermediate angled struts 112S2.

[0259] Fig. 24A shows a portion of a frame 106u of an exemplary prosthetic valve lOOu. Prosthetic valve lOOu is similar to any example described herein for prosthetic valve 100s, having all strut pairs 112 of the intermediate rung 114S oriented towards the outflow end, parallel to the inflow rung 1141, except that all strut pairs 112 of the outflow rung 1140 are oriented towards the inflow end, opposite to the orientation of the intermediate rung 114S immediately distal thereto.

[0260] This configuration of the frame 106u, having inflow and intermediate rungs 1141, 114S similarly oriented to the inflow and intermediate rungs of the frame 106s shown in Fig. 22, can allow for the use of an axially longer skirt 190 which can provide a higher sealing length between the prosthetic valve and the surrounding anatomy, in a similar manner to that described above with respect to prosthetic valve 100s. Nevertheless, in contrast to the valve 100s, the outflow rung 1140 of the frame 106u preserves the inflow-directed orientation of its pairs of struts, thereby advantageously eliminating valve foreshortening from the same reasons discussed above with respect to exemplary valve 10a and 10b for example. In some examples, the vertices 134 of the outflow rung 1140 and of the intermediate rung 114S of the frame 106u are sufficiently spaced from each other in the axial direction, to prevent these rungs from crossing each other both in the compressed and the expanded states of the frame.

[0261] Fig. 24B shows a portion of a frame 106v of an exemplary prosthetic valve lOOv. Prosthetic valve lOOv is similar to any example described herein for prosthetic valve lOOu, except that the frame 106v further comprises vertical stabilization struts 152 axially extending between vertices 134 of the inflow rung 1141 and the intermediate rung 114S. The vertical stabilization struts 152 are parallel to each other and to the axial frame members 116, and can be equal in length to the length of the inflow axial segments 11 1. Each vertical stabilization strut 152 is disposed between two immediately adjacent inflow axial segments 1181, effectively splitting the portion defined between two immediately adjacent inflow axial members 1181 into two inflow cells 1281 having about half the width of the outflow cells 1240. In this manner, the relatively elongated inflow cell row 1301 of prosthetic valve lOOv can be strengthened bythe addition of the vertical stabilization struts 152, which can reduce the risk of frame distortion during crimping and / or expansion.

[0262] Fig. 25 A shows a portion of a frame 106w of an exemplary prosthetic valve lOOw. Prosthetic valve lOOf is an exemplary implementation of prosthetic valve 100, and thus can include any of the features described for prosthetic valve 100 throughout the current disclosure, except for having longer inflow axial segments 1180, relative to their lengths as shown for prosthetic valve 10a in Figs. 1A-1C, for example.

[0263] The orientation of all strut rungs 1 14 of the frame 106w can be generally similar to those described above with respect to exemplary frame 106a, such that all stmt pairs 112 of the outflow rung 1140 and all stmt pairs 112 or the intermediate rung 114S are oriented towards the inflow end, parallel to each other, while all stmt pairs 112 of the inflow mng 1141 are oriented towards the outflow end. However, the axial position of the intermediate mng 114S of the frame 106w can be axially offset farther away from the outflow mng 1140, resulting in higher outflow cells 1280, compared to the height (or axial length) of the outflow cells 1280 of prosthetic valve 10a as illustrated in Figs. 1A-1C, for example. In some examples, the outflow axial segments 1180 of the frame 106w are at least as long as, and optionally longer than, the inflow axial segments 1181.

[0264] The increased size of the outflow cells 1280 can advantageously provide a larger opening for blood flow and / or coronary access, as discussed above with respect to exemplary prosthetic valve lOOq of Fig. 21 A. However, in contrast to the valve lOOq, the outflow mng 1140 of the frame 106w preserves the inflow-directed orientation of its pairs of stmts, thereby advantageously eliminating valve foreshortening from the same reasons discussed above with respect to exemplary valve 10a for example.

[0265] Fig. 25B shows a portion of a frame 106x of an exemplary prosthetic valve lOOx. Prosthetic valve lOOx is similar to any example described herein for prosthetic valve lOOw, except that the frame 106x further comprises vertical stabilization stmts 152 axially extending between vertices 134 of the outflow mng 1140 and the intermediate mng 114S. The vertical stabilization stmts 152 are parallel to each other and to the axial frame members 116, and can be equal in length of the length of the outflow axial segments 1180. Each vertical stabilization stmt 152 is disposed between two immediately adjacent outflow axial segments 1180, effectively splitting the portion defined between two immediately adjacent outflow axial segments 1180 into two outflow cells 1280 having about half the width of the inflow cells 1281. In this manner, the relatively elongated outflow cell row 1300 of prosthetic valve lOOxcan be strengthened by the addition of the vertical stabilization struts 152, which can reduce the risk of frame distortion during crimping and / or expansion.

[0266] Fig. 26 shows a third of an exemplary prosthetic valve lOOy. Prosthetic valve lOOy is an exemplary implementation of prosthetic valve 100, and thus can include any of the features described for prosthetic valve 100 throughout the current disclosure, except that the inflow rung 1141 of the frame 106y of prosthetic valve lOOy includes non-uniformly oriented pairs of struts 112, such that some of the pairs of struts 112 can be oriented towards the inflow end, and some can be oriented towards the outflow end.

[0267] As shown, two non-commissural axial members 120-1 and 120-2 are disposed between two immediately adjacent commissure support axial members 122a and 122b, resulting in a total of three pairs of struts 112 of each rung 114 extending between the two immediately adjacent commissure support axial members 122a and 122b. For example, the inflow rung 1 141 is shown to include a first pair of stmts 112-1 disposed between the first commissure support axial member 122a and the first non-commissural axial member 120-1, a second pair of stmts 112-2 disposed between the first non-commissural axial member 120-1 and the second non- commissural axial member 120-2, and a third pair of stmts 112-3 disposed between the second non-commissural axial member 120-2 and the second commissure support axial member 122b.

[0268] All pairs of stmts 112 of the outflow rung 1140, and all pairs of stmts 112 of the intermediate mng 114S, can be uniformly oriented in the same direction, optionally oriented towards the inflow end such that the outflow mng 1140 and the intermediate mng 114S can be parallel to each other.

[0269] All pairs of stmts 112 of the inflow mng 1141 extending between (and connected to) a commissure support axial member 122 and a non-commissural axial member 120 are oriented towards the outflow end, while all pairs of stmts 112 of the inflow mng 1141 extending between (and connected to) immediately adjacent non-commissural axial members 120 are oriented towards the inflow end. For example, the first pair of stmts 112-1 and the third pair of stmts 112-3 are shown to be oriented towards the outflow end, while the second pair of stmts 112-2 disposed therebetween, is shown to be oriented towards the inflow end.

[0270] The intersections of the inflow mng 1141 with the commissure support axial members 122 define first inflow apices 138-1, while the vertices 134 of the second pairs of stmts 112-2 disposed between immediately adjacent non-commissural axial members 120 define second inflow apices 138-2 which are distal to the first inflow apices 138-1.

[0271] In some examples, each leaflet 172 can be secured (e.g., sutured) along its cusp end portion 178 directly to stmts 108 of the frame 106. The cusp end portion 178 of a leaflet 172can define a single scallop having a midpoint 182 that can be the lowermost or distal-most point of the leaflet 172. While a frame having outflow and inflow rungs oriented towards each other, as shown for example for exemplary frame 106a in Figs. 1A-1C, can have a relatively short overall length (dictated, for example, by the length of the axial frame members 116), it may be desired to locally extend the frame at region of the cusp line midpoints 182 to support attachment of leaflets 172 at the lowermost regions. A frame 106y having pairs of struts 112-2 inverted relative to other pairs of struts 112-1, 112-3 of the inflow rung 1141 can offset the vertices 134 defined by the downwardly-oriented pairs 1 12-2 (which are also inflow apices 138-2 of the frame) farther from the inflow ends of the commissure support axial members 122 (which also define inflow apices 138-1 of the frame).

[0272] As a result, the inflow cell row 1301 of the exemplary frame 106y illustrated in Fig. 26 includes two types of inflow cells 1281, namely regular inflow cells 12811 and elongated inflow cells 12812, wherein the axial distance between vertices of the intermediate rung 114S and the inflow rung 1141 is greater for an elongated inflow cell 12812 than for a regular inflow cell 12811.

[0273] The second inflow apices 138-2 defined by vertices 134 of the second pairs of struts 112-2 are circumferentially aligned with the cusp line midpoints 182 of the leaflets 172, such that the cusp line midpoints 182 can be coupled (e.g., sutured) to the second inflow apices 138- 2.

[0274] In some instances, prosthetic valves can experience unwanted tissue overgrowth at the lower end portions of the leaflets (e.g., the portion of the leaflet closer to the cusp end midpoint 182). As further mentioned above, a prosthetic valve can further include a skirt 190 extending around a circumference of the frame 102. In such instances, blood may accumulate in a pocket formed between the leaflets and the skirt.

[0275] In some examples, the inverted pair of struts 112-2 to which the cusp end portions 178 of the leaflets 172 are attached, are configured to resiliently bend radially inwards about their joints 132 and revert to a free unbent position thereof during cycling of the leaflets between the closed and open states. When the leaflets 172 close under the back flow of blood, each inverted pair of struts 112-2 coupled to the lower cusp end portion 178 of the leaflets 172 can bend or deflect radially inwardly towards the central longitudinal axis CA. When the leaflets 172 open under the forward flow of blood, each inverted pair of struts 112-2 can revert to a free unbent configuration thereof, and in some examples, can optionally even deflect radially outwards farther from the central longitudinal axis CA. Advantageously, such bending motion canimprove leaflet mobility to facilitate blood washout from a "pocket" that may be formed between the leaflet and the skirt, as described above.

[0276] While the major portion of the frame 106y extending between the outflow apices 136 at the outflow end 102 and the first inflow apices 138-1 does not foreshorten at all, limited total foreshortening of the frame 106y is equal to the foreshortening of the inverted stmt pairs 112- 2. Advantageously, the reduced extent of foreshortening offered by this frame design means that the length of the frame during deployment is reduced, such that it more easily works its way around highly bent portions of a tortuous vascular path. Moreover, the reduced foreshortening offers easier alignment of the prosthetic valve lOOy with the native annulus, for example.

[0277] Any of the assemblies, devices, apparatuses, etc. herein can be sterilized (for example, with heat, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated assembly, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.Some Examples of the Disclosed Implementations

[0278] Some examples of above-described implementations are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application.

[0279] Example 1. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, the frame comprising: a plurality of strut rungs, each comprising a plurality of struts pairs arranged around a circumference of the frame, wherein each stmt pair comprises two angled stmts diverging from a mutual vertex to opposite junctures at which the angled stmts are connected to axial frame members which are circumferentially spaced from each other, the plurality of stmt mngs comprising: an outflow rung defining an outflow end of the frame, an inflow mng defining an inflow end of the frame, and an intermediate mng therebetween; wherein the stmt pairs of the inflow mng comprise: a plurality of stmt pairs oriented towards the inflow end, each disposed between two stmt pairs oriented towards the outflow end.

[0280] Example 2. The prosthetic valve of any example herein, particularly of example 1, further comprising a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.

[0281] Example 3. The prosthetic valve of any example herein, particularly of example 2, wherein each leaflet comprises a free edge closer to the outflow end, and a cusp end portion closer to the inflow end.

[0282] Example 4. The prosthetic valve of any example herein, particularly of example 3, wherein the cusp end portions of the leaflets are coupled to the stmt pairs of the inflow rang which are oriented towards the inflow end.

[0283] Example 5. The prosthetic valve of any example herein, particularly of any one of examples 3-4, wherein midpoints of the cusp end portions are coupled to the vertices of the strut pairs of the inflow rang which are oriented towards the inflow end.

[0284] Example 6. The prosthetic valve of any example herein, particularly of any one of examples 4-5, wherein the strut pairs of the inflow rang which are oriented towards the inflow end are configured to resiliently bend radially inwards when the leaflets move to a closed state in which the leaflets coapt with each other.

[0285] Example 7. The prosthetic valve of any example herein, particularly of any one of examples 2-6, wherein the axial frame members comprise: a plurality of commissure support axial members, and a plurality of non-commissural axial members.

[0286] Example 8. The prosthetic valve of any example herein, particularly of example 7, wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support axial members.

[0287] Example 9. The prosthetic valve of any example herein, particularly of any one of examples 7-8, wherein each of the plurality of commissure support axial members comprises a commissure window opening.

[0288] Example 10. The prosthetic valve of any example herein, particularly of any one of examples 7-9, wherein two immediately adjacent non-commissural axial members are disposed between two immediately adjacent commissure support axial members.

[0289] Example 11. The prosthetic valve of any example herein, particularly of example 10, wherein each strut pair of the inflow rang, which is oriented towards the inflow end, extends between two non-commissural axial members.

[0290] Example 12. The prosthetic valve of any example herein, particularly of any one of examples 10-11, wherein each strut pair of the inflow rang, which is oriented towards theoutflow end, extends between a commissure support frame member and a non-commissural axial members.

[0291] Example 13. The prosthetic valve of any example herein, particularly of any one of examples 7-12, wherein the junctures connecting the strut pairs of the inflow rung with the commissure support axial members define first inflow apices of the frame.

[0292] Example 14. The prosthetic valve of any example herein, particularly of example 13, wherein the vertices of the strut pairs of the inflow rung which are oriented towards the inflow end define second inflow apices which are distal to the first inflow apices.

[0293] Example 15. The prosthetic valve of any example herein, particularly of any one of examples 1-14, wherein all of the strut pairs of the outflow rung are oriented towards the inflow end.

[0294] Example 16. The prosthetic valve of any example herein, particularly of any one of examples 1-15, wherein all of the strut pairs of the intermediate rung are oriented towards the inflow end.

[0295] Example 17. The prosthetic valve of any example herein, particularly of any one of examples 1-16, further comprising a skirt disposed around the frame.

[0296] Example 18. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, the frame comprising: a plurality of strut rungs, each comprising a plurality of struts pairs arranged around a circumference of the frame, wherein each strut pair comprises two angled struts diverging from a mutual vertex to opposite junctures at which the angled struts are connected to axial frame members which are circumferentially spaced from each other, the plurality of strut rungs comprising: an outflow rung defining an outflow end of the frame, an inflow rung defining an inflow end of the frame, and an intermediate rung therebetween; and a plurality of vertical stabilization struts, each extending axially between vertices of two of the plurality of rungs; wherein the vertical stabilization struts are axially shorter than the axial frame members.

[0297] Example 19. The prosthetic valve of any example herein, particularly of example 18, wherein the vertical stabilization struts are parallel to the axial frame members and to a central longitudinal axis of the frame.

[0298] Example 20. The prosthetic valve of any example herein, particularly of any one of examples 18-19, wherein at least two of the plurality of strut rungs are devoid of vertical stabilization stmts extending therebetween.

[0299] Example 21. The prosthetic valve of any example herein, particularly of any one of examples 18-20, wherein all of the strut pairs of the outflow rung are oriented towards the inflow end.

[0300] Example 22. The prosthetic valve of any example herein, particularly of any one of examples 18-21, wherein all of the stmt pairs of the inflow rung are oriented towards the outflow end.

[0301] Example 23. The prosthetic valve of any example herein, particularly of any one of examples 18-22, wherein the vertical stabilization stmts extend between the inflow mng and the intermediate mng.

[0302] Example 24. The prosthetic valve of any example herein, particularly of example 23, wherein an axial distance between junctures of the inflow mng and the intermediate mng is greater than an axial distance between the outflow mng and the intermediate mng.

[0303] Example 25. The prosthetic valve of any example herein, particularly of any one of examples 23-24, wherein the stmt pairs of the intermediate mng are parallel to the stmt pairs of the inflow mng.

[0304] Example 26. The prosthetic valve of any example herein, particularly of any one of examples 23-25, wherein all of the stmt pairs of the intermediate mng are oriented towards the outflow end.

[0305] Example 27. The prosthetic valve of any example herein, particularly of any one of examples 23-26, further comprising a skirt disposed around the frame and extending from the inflow end to the intermediate mng.

[0306] Example 28. The prosthetic valve of any example herein, particularly of any one of examples 18-22, wherein the vertical stabilization stmts extend between the outflow mng and the intermediate mng.

[0307] Example 29. The prosthetic valve of any example herein, particularly of example 28, wherein an axial distance between junctures of the outflow mng and the intermediate mng is greater than an axial distance between the inflow mng and the intermediate mng.

[0308] Example 30. The prosthetic valve of any example herein, particularly of any one of examples 28-29, wherein the stmt pairs of the intermediate mng are parallel to the stmt pairs of the outflow mng.

[0309] Example 31. The prosthetic valve of any example herein, particularly of any one of examples 28-30, wherein all of the stmt pairs of the intemrediate mng are oriented towards the inflow end.

[0310] Example 32. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, the frame comprising: a plurality of strut rungs, each comprising a plurality of stmts pairs arranged around a circumference of the frame, wherein each stmt pair comprises two angled stmts diverging from a mutual vertex to opposite junctures at which the angled stmts are connected to axial frame members which are circumferentially spaced from each other, the plurality of strut mngs comprising: an outflow rung defining an outflow end of the frame, an inflow rang defining an inflow end of the frame, and an intermediate rang therebetween; wherein all of the strut pairs of the outflow rang are oriented towards the inflow end; wherein all of the strut pairs of the inflow rang are oriented towards the outflow end; and wherein an axial distance between the vertices of the intermediate rang and one of the inflow rang or the outflow rang is greater than an axial distance between the vertices of the intermediate rang and one of the inflow rang or the outflow rang.

[0311] Example 33. The prosthetic valve of any example herein, particularly of example 32, wherein the axial distance between junctures of the inflow rung and the intermediate rung is greater than the axial distance between the outflow rang and the intermediate rang.

[0312] Example 34. The prosthetic valve of any example herein, particularly of example 33, wherein the strut pairs of the intermediate rang are parallel to the stmt pairs of the inflow rang.

[0313] Example 35. The prosthetic valve of any example herein, particularly of any one of examples 33-34, wherein all of the stmt pairs of the intermediate rang are oriented towards the outflow end.

[0314] Example 36. The prosthetic valve of any example herein, particularly of example 32, wherein the axial distance between junctures of the outflow rang and the intermediate rang is greater than the axial distance between the inflow rang and the intermediate rang.

[0315] Example 37. The prosthetic valve of any example herein, particularly of example 36, wherein the strut pairs of the intermediate rang are parallel to the strut pairs of the outflow rang.

[0316] Example 38. The prosthetic valve of any example herein, particularly of any one of examples 36-37, wherein all of the strut pairs of the intermediate rang are oriented towards the inflow end.

[0317] Example 39. The prosthetic valve of any example herein, particularly of any one of examples 32-38, further comprising a skirt disposed around the frame and extending from the inflow end to the intermediate rang.

[0318] Example 40. The prosthetic valve of any example herein, particularly of any one of examples 32-39, further comprising a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.

[0319] Example 41. The prosthetic valve of any example herein, particularly of example 40, wherein the axial frame members comprise: a plurality of commissure support axial members, and a plurality of non-commissural axial members.

[0320] Example 42. The prosthetic valve of any example herein, particularly of example 41, wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support axial members.

[0321] Example 43. The prosthetic valve of any example herein, particularly of any one of examples 41-42, wherein each of the plurality of commissure support axial members comprises a commissure window opening.

[0322] Example 44. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, the frame comprising: a plurality of strut rungs, each comprising a plurality of stmts pairs arranged around a circumference of the frame, wherein each stmt pair comprises two angled stmts diverging from a mutual vertex to opposite junctures at which the angled stmts are connected to axial frame members which are circumferentially spaced from each other, the plurality of stmt mngs comprising: an outflow mng defining an outflow end of the frame, a first intermediate mng distal to the outflow mng, a second intermediate rang distal to the first intermediate rang, and an inflow rang distal to the second intermediate rang and defining an inflow end of the frame; wherein all of the strut pairs of the outflow mng and the second intermediate mng are oriented towards the inflow end; and wherein all of the strut pairs of the inflow rang and the first intermediate rang are oriented towards the outflow end.

[0323] Example 45. The prosthetic valve of any example herein, particularly of example 44, wherein the first intermediate rang and the second intermediate rang are connected to the axial frame members at mutual junctures.

[0324] Example 46. The prosthetic valve of any example herein, particularly of any one of examples 44-45, wherein the first intermediate rang and the second intermediate mng together define a row of diamond-shaped cells.

[0325] Example 47. The prosthetic valve of any example herein, particularly of any one of examples 44-46, wherein the vertices of all stmt pairs which are circumferentially aligned with each other, are axially spaced from each other in the radially expanded state of the frame.

[0326] Example 48. The prosthetic valve of any example herein, particularly of any one of examples 44-47, wherein the lengths of all of the angled struts are equal to each other.

[0327] Example 49. The prosthetic valve of any example herein, particularly of any one of examples 44-48, further comprising a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.

[0328] Example 50. The prosthetic valve of any example herein, particularly of example 49, wherein the axial frame members comprise: a plurality of commissure support axial members, and a plurality of non-commissural axial members.

[0329] Example 51. The prosthetic valve of any example herein, particularly of example 50, wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support members.

[0330] Example 52. The prosthetic valve of any example herein, particularly of any one of examples 50-51, wherein each of the plurality of commissure support members comprises a commissure window opening.

[0331] Example 53. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, the frame comprising: a plurality of axial frame members circumferentially spaced from each other and comprising: a plurality of commissure support axial members, and a plurality of non-commissural axial members; and a plurality of stmt rungs, each comprising a plurality of stmts pairs arranged around a circumference of the frame, wherein each stmt pair comprises two angled stmts diverging from a mutual vertex to opposite junctures at which the angled stmts are connected to two of the axial frame members, the plurality of stmt rungs comprising: an outflow mng defining an outflow end of the frame, an inflow mng defining an inflow end of the frame, and an intermediate mng therebetween; a valvular stmcture mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve; wherein all of the stmt pairs of the outflow mng and the inflow mng are oriented towards the outflow end; wherein each commissure support axial member comprises a commissure support segment extending between the junctures of the outflow mng and the intermediate mng; and wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support segments.

[0332] Example 54. The prosthetic valve of any example herein, particularly of example 53, wherein each commissure support segment comprises a commissure window opening.

[0333] Example 55. The prosthetic valve of any example herein, particularly of example 54, wherein tabs of two adjacent leaflets are configured to extend through a corresponding one of the commissure window openings.

[0334] Example 56. The prosthetic valve of any example herein, particularly of any one of examples 53-55, wherein each axial frame member comprises an outflow axial segment extending between the outflow rung and the intermediate rung, and an inflow axial segment extending between the intermediate rung and the inflow rung.

[0335] Example 57. The prosthetic valve of any example herein, particularly of example 56, wherein the frame further defines a row of outflow cells and a row of inflow cells; wherein each outflow cell is defined between one strut pair of the outflow rung, one strut pair of the intermediate rung, and two outflow axial segments extending therebetween; and wherein each inflow cells is defined between one stmt pair of the inflow rung, one stmt pair of the intermediate mng, and two outflow axial segments extending therebetween.

[0336] Example 58. The prosthetic valve of any example herein, particularly of example 57, wherein openings defined by the outflow cells are larger than openings defined by the inflow cells.

[0337] Example 59. The prosthetic valve of any example herein, particularly of any one of examples 53-58, wherein all of the stmt pairs of the intermediate mng are oriented towards the inflow end.

[0338] Example 60. The prosthetic valve of any example herein, particularly of any one of examples 53-57, wherein all of the stmt pairs of the intermediate mng are oriented towards the outflow end.

[0339] Example 61. The prosthetic valve of any example herein, particularly of any one of examples 53-60, further comprising a skirt disposed around the frame and extending from the inflow end to the vertices of the intermediate mng.

[0340] Example 62. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, the frame comprising; a plurality of stmt mngs, each comprising a plurality of stmts pairs arranged around a circumference of the frame, wherein each stmt pair comprises two angled stmts diverging from a mutual vertex to opposite junctures at which the angled stmts are connected to axial frame members which are circumferentially spaced from each other, the plurality of stmt mngs comprising; an outflow mng defining an outflow end of the frame, an inflow rang defining an inflow end of the frame, and an intermediate rung therebetween; and a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, wherein each leaflet comprises a cusp end portion closer to the inflow end and a free edge closer to the outflow end; wherein a medial free edge portion of the free edge of the leaflets is axially offset by a minimal axial distance from the outflow end of the frame.

[0341] Example 63. The prosthetic valve of any example herein, particularly of example 62, wherein the minimal axial distance is greater than 1.5 millimeters.

[0342] Example 64. The prosthetic valve of any example herein, particularly of example 62, wherein the minimal axial distance is greater than 2 millimeters.

[0343] Example 65. The prosthetic valve of any example herein, particularly of any one of examples 62-64, wherein a lateral length of the medial free edge portion is greater than 50% of a total length of the free edge.

[0344] Example 66. The prosthetic valve of any example herein, particularly of any one of examples 62-64, wherein a lateral length of the medial free edge portion is greater than 70% of a total length of the free edge.

[0345] Example 67. The prosthetic valve of any example herein, particularly of any one of examples 62-64, wherein a lateral length of the medial free edge portion is greater than 75% of a total length of the free edge.

[0346] Example 68. The prosthetic valve of any example herein, particularly of any one of examples 62-64, wherein a lateral length of the medial free edge portion is greater than 80% of a total length of the free edge.

[0347] Example 69. The prosthetic valve of any example herein, particularly of any one of examples 62-68, wherein all of the strut pairs of the outflow rung are oriented towards the inflow end.

[0348] Example 70. The prosthetic valve of any example herein, particularly of example 69, wherein the outflow end of the frame is defined at the level of outflow apices which are defined at the junctures connecting the outflow rung to the axial frame members.

[0349] Example 71. The prosthetic valve of any example herein, particularly of any one of examples 62-70, wherein all of the stmt pairs of the inflow rung are oriented towards the outflow end.

[0350] Example 72. The prosthetic valve of any example herein, particularly of any one of examples 62-71, wherein the axial frame members comprise: a plurality of commissure support axial members, and a plurality of non-commissural axial members.

[0351] Example 73. The prosthetic valve of any example herein, particularly of example 72, wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support members.

[0352] Example 74. The prosthetic valve of any example herein, particularly of any one of examples 72-73, wherein each of the plurality of commissure support members comprises a commissure window opening.

[0353] Example 75. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, the frame comprising: a plurality of axial frame members circumferentially spaced from each other and comprising: a plurality of commissure support axial members, and a plurality of non-commissural axial members; and a plurality of stmt rungs, each comprising a plurality of stmts pairs arranged around a circumference of the frame, wherein each stmt pair comprises two angled stmts diverging from a mutual vertex to opposite junctures at which the angled stmts are connected to two of the axial frame members, the plurality of stmt rungs comprising: an outflow mng defining an outflow end of the frame, an inflow mng defining an inflow end of the frame, and an intermediate mng therebetween; and a plurality of top markers, each extending proximally from a corresponding one of the commissure support axial members and comprising a neck portion and a head portion; and a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve; wherein the top markers are configured to atraumatically engage a tissue when pressed thereagainst upon implantation of the prosthetic valve.

[0354] Example 76. The prosthetic valve of any example herein, particularly of example 75, wherein the head portion laterally extends to one side from the neck portion.

[0355] Example 77. The prosthetic valve of any example herein, particularly of any one of examples 75-76, wherein a lateral length of the head portion is equal to or greater than 1 millimeter.

[0356] Example 78. The prosthetic valve of any example herein, particularly of any one of examples 75-76, wherein a lateral length of the head portion is equal to or greater than 1.5 millimeters.

[0357] Example 79. The prosthetic valve of any example herein, particularly of any one of examples 75-76, wherein a lateral length of the head portion is equal to or greater than 2 millimeters.

[0358] Example 80. The prosthetic valve of any example herein, particularly of any one of examples 75-79, wherein the head portion is covered by a covering element.

[0359] Example 81. The prosthetic valve of any example herein, particularly of example 80, wherein the covering element comprises a cap encapsulating the head portion.

[0360] Example 82. The prosthetic valve of any example herein, particularly of example 81, wherein an outer surface of the cap is curved.

[0361] Example 83. The prosthetic valve of any example herein, particularly of example 82, wherein the outer surface of the cap is semi-spherical.

[0362] Example 84. The prosthetic valve of any example herein, particularly of any one of examples 75-83, wherein the neck portion is configured to bend when the top marker is pressed against the tissue.

[0363] Example 85. The prosthetic valve of any example herein, particularly of example 84, wherein the neck portion is flexible.

[0364] Example 86. The prosthetic valve of any example herein, particularly of any one of examples 84-85, wherein an axial length of the neck portion is greater than 2 millimeters.

[0365] Example 87. The prosthetic valve of any example herein, particularly of any one of examples 84-85, wherein an axial length of the neck portion is greater than 3 millimeters.

[0366] Example 88. The prosthetic valve of any example herein, particularly of any one of examples 84-85, wherein an axial length of the neck portion is greater than 4 millimeters.

[0367] Example 89. The prosthetic valve of any example herein, particularly of any one of examples 84-88, wherein a length to width ration of the neck portion is greater than 3.

[0368] Example 90. The prosthetic valve of any example herein, particularly of any one of examples 84-88, wherein a length to width ration of the neck portion is greater than 4.

[0369] Example 91. The prosthetic valve of any example herein, particularly of any one of examples 84-90, wherein the neck portion is serpentine-shaped.

[0370] Example 92. The prosthetic valve of any example herein, particularly of any one of examples 75-91, wherein all of the strut pairs of the outflow rung are oriented towards the inflow end.

[0371] Example 93. The prosthetic valve of any example herein, particularly of any one of examples 75-92, wherein all of the stmt pairs of the inflow rung are oriented towards the outflow end.

[0372] Example 94. The prosthetic valve of any example herein, particularly of any one of examples 75-93, wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support members.

[0373] Example 95. The prosthetic valve of any example herein, particularly of any one of examples 93-94, wherein each of the plurality of commissure support members comprises a commissure window opening.

[0374] Example 96. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, the frame comprising: a plurality of axial frame members circumferentially spaced from each other and comprising: a plurality of commissure support axial members, and a plurality of non-commissural axial members; and a plurality of strut rungs, each comprising a plurality of struts pairs arranged around a circumference of theframe, wherein each strut pair comprises two angled stmts diverging from a mutual vertex to opposite junctures at which the angled stmts are connected to two of the axial frame members, the plurality of stmt rungs comprising: an outflow mng defining an outflow end of the frame, an inflow mng defining an inflow end of the frame, and an intermediate mng therebetween; and a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve; wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support axial member; and wherein a frame portion disposed on one side of the commissure support axial member includes a differently shaped feature compared to an equivalent feature of a frame portion disposed on the opposite side of the commissure support axial member.

[0375] Example 97. The prosthetic valve of any example herein, particularly of example 96, wherein the differently shaped feature comprises a widened portion of a corresponding one of the non-commissural axial members.

[0376] Example 98. The prosthetic valve of any example herein, particularly of example 97, wherein each axial frame member comprises a plurality of axial segments, each defined as a portion of the axial frame member extending between junctures of two of the strut rungs.

[0377] Example 99. The prosthetic valve of any example herein, particularly of example 97, wherein each axial segment comprises an outflow axial segment extending between the outflow rung and the intermediate rung, and wherein the corresponding outflow axial segment comprises the widened portion.

[0378] Example 100. The prosthetic valve of any example herein, particularly of example 99, wherein the widened portion comprises a uniform width along at least 75% of the length of the corresponding outflow axial segment, which is wider than the width of an equivalent axial segment of the opposite frame portion.

[0379] Example 101. The prosthetic valve of any example herein, particularly of any one of examples 97-99, wherein the widened portion comprises a bulge of the corresponding axial frame.

[0380] Example 102. The prosthetic valve of any example herein, particularly of example 101, wherein the bulge is circularly-shaped.

[0381] Example 103. The prosthetic valve of any example herein, particularly of any one of examples 101-102, further comprising an aperture extending through the bulge.

[0382] Example 104. The prosthetic valve of any example herein, particularly of any one of examples 97-102, further comprising a radiopaque component attached to the widened portion.

[0383] Example 105. The prosthetic valve of any example herein, particularly of example 96, wherein the differently shaped feature comprises an enlarged joint.

[0384] Example 106. The prosthetic valve of any example herein, particularly of example 105, wherein the enlarged joint is one of the joints of the intermediate rang.

[0385] Example 107. The prosthetic valve of any example herein, particularly of example 105, wherein the joints of the outflow rung define outflow apices of the frame, and wherein the enlarged joint is an enlarged outflow apex.

[0386] Example 108. The prosthetic valve of any example herein, particularly of any one of examples 105-107, further comprising an aperture extending through the enlarged joint.

[0387] Example 109. The prosthetic valve of any example herein, particularly of any one of examples 105-107, further comprising a radiopaque component attached to the enlarged joint.

[0388] Example 110. The prosthetic valve of any example herein, particularly of any one of examples 96-109, wherein all of the strut pairs of the outflow rang are oriented towards the inflow end.

[0389] Example 111. The prosthetic valve of any example herein, particularly of any one of examples 96-110, wherein all of the strut pairs of the inflow rang are oriented towards the outflow end.

[0390] Example 112. The prosthetic valve of any example herein, particularly of any one of examples 96-111, wherein each of the plurality of commissure support members comprises a commissure window opening.

[0391] Example 113. The prosthetic valve of any example herein, particularly of any one of examples 1-112, wherein the vertices of the outflow rang comprise arcuate regions defined between upper and lower curved surfaces thereof.

[0392] Example 114. The prosthetic valve of any example herein, particularly of any one of examples 1-113, wherein the vertices of the intermediate rung comprise arcuate regions defined between upper and lower curved surfaces thereof.

[0393] Example 115. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, the frame comprising: a plurality of strut rungs, each comprising a plurality of struts pairs arranged around a circumference of the frame, wherein each strut pair comprises two angled struts diverging from a mutual vertex to opposite junctures at which the angled struts are connected to axial frame members which are circumferentially spaced from each other, the plurality of strut rungs comprising: an outflow rung defining an outflow end of the frame, an inflow rang defining an inflow end of the frame, and an intermediate rang therebetween; and a valvular structure mounted inside the frame andcomprising a plurality of leaflets configured to regulate flow through the prosthetic valve, wherein each leaflet comprises a cusp end portion closer to the inflow end and a free edge closer to the outflow end; wherein the vertices of the outflow rung comprise arcuate regions defined between upper and lower curved surfaces thereof.

[0394] Example 116. The prosthetic valve of any example herein, particularly of example 115, wherein the vertices of the intermediate rung comprise arcuate regions defined between upper and lower curved surfaces thereof.

[0395] Example 1 17. The prosthetic valve of any example herein, particularly of any one of examples 115-116, wherein all of the strut pairs of the outflow rung are oriented towards the inflow end.

[0396] Example 118. The prosthetic valve of any example herein, particularly of any one of examples 115-117, wherein all of the strut pairs of the inflow rung are oriented towards the outflow end.

[0397] Example 119. The prosthetic valve of any example herein, particularly of any one of examples 115-118, wherein the intermediate rung is a first intermediate rung distal to the outflow rung, and wherein the plurality of rungs further comprises a second intermediate rung disposed between the first intermediate rung and the inflow rung.

[0398] Example 120. The prosthetic valve of any example herein, particularly of any one of examples 113-119, wherein the arcuate regions define a width which is less than a width of the angled struts continuously extending therefrom.

[0399] Example 121. The prosthetic valve of any example herein, particularly of any one of examples 1-120, wherein the axial frame members are at least partially covered by at least one covering member.

[0400] Example 122. The prosthetic valve of any example herein, particularly of any one of examples 1-121, wherein the outflow rung is covered by at least one covering member.

[0401] Example 123. The prosthetic valve of any example herein, particularly of any one of examples 1-122, wherein the intermediate rung is covered by at least one covering member.

[0402] Example 124. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, the frame comprising a plurality of struts that comprise: a plurality of axial frame members circumferentially spaced from each other and comprising: a plurality of commissure support axial members, and a plurality of non- commissural axial members; and a plurality of strut rungs, each comprising a plurality of struts pairs arranged around a circumference of the frame, wherein each strut pair comprises two angled struts diverging from a mutual vertex to opposite junctures at which the angled strutsare connected to two of the axial frame members, the plurality of strut rungs comprising: an outflow rung defining an outflow end of the frame, an inflow rung defining an inflow end of the frame, and an intermediate rung therebetween; and a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve; wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support axial member; and wherein at least some struts are covered by at least one covering member.

[0403] Example 125. The prosthetic valve of any example herein, particularly of example 124, wherein each axial frame member comprises an outflow axial segment extending between the outflow rung and the intermediate rung.

[0404] Example 126. The prosthetic valve of any example herein, particularly of example 125, wherein the outflow axial segments of the non-commissural axial members are covered by the at least one covering member.

[0405] Example 127. The prosthetic valve of any example herein, particularly of any one of examples 124-126, wherein the angled struts of the outflow rung are covered by the at least one covering member.

[0406] Example 128. The prosthetic valve of any example herein, particularly of any one of examples 124-127, wherein the angled struts of the intermediate rung are covered by the at least one covering member.

[0407] Example 129. The prosthetic valve of any example herein, particularly of any one of examples 124-128, wherein the vertices of the outflow rung are covered by the at least one covering member.

[0408] Example 130. The prosthetic valve of any example herein, particularly of any one of examples 124-129, wherein the vertices of the intermediate rung are covered by the at least one covering member.

[0409] Example 131. The prosthetic valve of any example herein, particularly of any one of examples 124-130, wherein all of the strut pairs of the outflow rung are oriented towards the inflow end.

[0410] Example 132. The prosthetic valve of any example herein, particularly of any one of examples 124-131, wherein all of the strut pairs of the inflow rung are oriented towards the outflow end.

[0411] Example 133. The prosthetic valve of any example herein, particularly of any one of examples 124-132, wherein the intermediate rung is a first intermediate rung distal to theoutflow rung, and wherein the plurality of rungs further comprises a second intermediate rung disposed between the first intermediate rung and the inflow rung.

[0412] Example 134. The prosthetic valve of any example herein, particularly of any one of examples 121-133, wherein the at least one covering member comprises a strip wrapped around a corresponding portion of the frame covered thereby.

[0413] Example 135. The prosthetic valve of any example herein, particularly of any one of examples 121-133, wherein the at least one covering member comprises a layer coating a corresponding portion of the frame covered thereby.

[0414] Example 136. The prosthetic valve of any example herein, particularly of any one of examples 1-135, further comprising a radiopaque marker attached to a commissure formed by tabs of two adjacent leaflets secured to each other.

[0415] Example 137. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, the frame comprising a plurality of struts that comprise: a plurality of axial frame members circumferentially spaced from each other and comprising: a plurality of commissure support axial members, and a plurality of non- commissural axial members: and a plurality of strut rungs, each comprising a plurality of struts pairs arranged around a circumference of the frame, wherein each strut pair comprises two angled struts diverging from a mutual vertex to opposite junctures at which the angled stmts are connected to two of the axial frame members, the plurality of stmt mngs comprising: an outflow mng defining an outflow end of the frame, an inflow mng defining an inflow end of the frame, and an intermediate mng therebetween; and a valvular stmcture mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve; wherein tabs of each two adjacent leaflets are coupled to each other at commissures attached to the commissure support axial member; and wherein a radiopaque marker attached to each of the commissures.

[0416] Example 138. The prosthetic valve of any example herein, particularly of example 137, wherein all of the stmt pairs of the outflow mng are oriented towards the inflow end.

[0417] Example 139. The prosthetic valve of any example herein, particularly of any one of examples 137-138, wherein all of the stmt pairs of the inflow mng are oriented towards the outflow end.

[0418] Example 140. The prosthetic valve of any example herein, particularly of any one of examples 137-139, wherein the intermediate mng is a first intermediate mng distal to the outflow mng, and wherein the plurality of mngs further comprises a second intermediate mng disposed between the first intermediate rang and the inflow mng.

[0419] Example 141. The prosthetic valve of any example herein, particularly of any one of examples 136-140, wherein the radiopaque marker is sutured to an outwardly facing surface of the corresponding commissure.

[0420] Example 142. The prosthetic valve of any example herein, particularly of any one of examples 136-141, wherein the radiopaque marker is asymmetric.

[0421] Example 143. The prosthetic valve of any example herein, particularly of example 142, wherein the radiopaque marker is C-shaped.

[0422] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate examples, may also be provided in combination in a single example. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single example, may also be provided separately or in any suitable sub-combination or as suitable in any other described example of the disclosure. No feature described in the context of an example is to be considered an essential feature of that example, unless explicitly specified as such.

[0423] In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope. Rather, the scope is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.

Claims

CLAIMS1. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, the frame comprising: a plurality of stmt rungs, each comprising a plurality of struts pairs arranged around a circumference of the frame, wherein each stmt pair comprises two angled stmts diverging from a mutual vertex to opposite junctures at which the angled stmts are connected to axial frame members which are circumferentially spaced from each other, the plurality of stmt rungs comprising: an outflow rang defining an outflow end of the frame, an inflow rang defining an inflow end of the frame, and an intermediate rung therebetween; wherein the strut pairs of the inflow rang comprise: a plurality of strut pairs oriented towards the inflow end, each disposed between two strut pairs oriented towards the outflow end.

2. The prosthetic valve of claim 1 , further comprising a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, wherein each leaflet comprises a free edge closer to the outflow end, and a cusp end portion closer to the inflow end, and wherein the cusp end portions of the leaflets are coupled to the strut pairs of the inflow rang which are oriented towards the inflow end.

3. The prosthetic valve of claim 2, wherein midpoints of the cusp end portions are coupled to the vertices of the strut pairs of the inflow rang which are oriented towards the inflow end.

4. The prosthetic valve of any one of claims 2-3, wherein the axial frame members comprise: a plurality of commissure support axial members; and a plurality of non-commissural axial members, and wherein two immediately adjacent non-commissural axial members are disposed between two immediately adjacent commissure support axial members.

5. The prosthetic valve of claim 4, wherein each strut pair of the inflow rang, which is oriented towards the inflow end, extends between two non- commissural axial members.

6. The prosthetic valve of any one of claims 1-5, wherein all of the strut pairs of the outflow rung are oriented towards the inflow end.

7. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, the frame comprising: a plurality of stmt rungs, each comprising a plurality of struts pairs arranged around a circumference of the frame, wherein each stmt pair comprises two angled stmts diverging from a mutual vertex to opposite junctures at which the angled stmts are connected to axial frame members which are circumferentially spaced from each other, the plurality of stmt rungs comprising: an outflow rang defining an outflow end of the frame, an inflow rang defining an inflow end of the frame, and an intermediate rang therebetween; and a plurality of vertical stabilization struts, each extending axially between vertices of two of the plurality of rungs; wherein the vertical stabilization struts are axially shorter than the axial frame members.

8. The prosthetic valve of claim 7, wherein at least two of the plurality of strut rungs are devoid of vertical stabilization struts extending therebetween.

9. The prosthetic valve of any one of claims 7-8, wherein all of the strut pairs of the outflow rang are oriented towards the inflow end.

10. The prosthetic valve of any one of claims 7-9, wherein all of the strut pairs of the inflow rang are oriented towards the outflow end.

11. The prosthetic valve of any one of claims 7-10, wherein the vertical stabilization struts extend between the inflow rang and the intermediate rang.

12. The prosthetic valve of claim 11, wherein an axial distance between junctures of the inflow rang and the intermediate rang is greater than an axial distance between the outflow rang and the intermediate rang.

13. The prosthetic valve of any one of claims 11-12, wherein all of the strut pairs of the intermediate rang are oriented towards the outflow end.

14. The prosthetic valve of any one of claims 7-10, wherein the vertical stabilization struts extend between the outflow rang and the intermediate rang.

15. The prosthetic valve of claim 14, wherein an axial distance between junctures of the outflow rung and the intermediate rung is greater than an axial distance between the inflow rung and the intermediate rung.

16. The prosthetic valve of any one of claims 14-15, wherein all of the stmt pairs of the intermediate rung are oriented towards the inflow end.

17. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, the frame comprising: a plurality of axial frame members circumferentially spaced from each other and comprising: a plurality of commissure support axial members, and a plurality of non-commissural axial members; and a plurality of stmt mngs, each comprising a plurality of stmts pairs arranged around a circumference of the frame, wherein each stmt pair comprises two angled stmts diverging from a mutual vertex to opposite junctures at which the angled stmts are connected to two of the axial frame members, the plurality of stmt mngs comprising: an outflow mng defining an outflow end of the frame, an inflow mng defining an inflow end of the frame, and an intermediate mng therebetween; and a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve; wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support axial member; and wherein a frame portion disposed on one side of the commissure support axial member includes a differently shaped feature compared to an equivalent feature of a frame portion disposed on the opposite side of the commissure support axial member.

18. The prosthetic valve of claim 17, wherein the differently shaped feature comprises a widened portion of a corresponding one of the non-commissural axial members.

19. The prosthetic valve of claim 18, wherein the widened portion comprises a uniform width along at least 75% of the length of an axial segment of thecorresponding non-commissural axial member, which is wider than the width of an equivalent axial segment of the opposite frame portion.

20. The prosthetic valve of claim 18, wherein the widened portion comprises a bulge of the corresponding axial frame, and an aperture extending through the bulge.

21. The prosthetic valve of claim 17, wherein the differently shaped feature comprises an enlarged joint.

22. The prosthetic valve of claim 21 , further comprising an aperture extending through the enlarged joint.

23. The prosthetic valve of any one of claims 1-22, wherein the vertices of the outflow rung comprise arcuate regions defined between upper and lower curved surfaces thereof.

24. The prosthetic valve of any one of claims 1-23, wherein the axial frame members are at least partially covered by at least one covering member.

25. The prosthetic valve of any one of claims 1-24, wherein the outflow rung is covered by at least one covering member.

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