Leaflets for prosthetic valves

Abstract

A prosthetic valve constituted of: a frame movable between a radially compressed and a radially expanded state; and a plurality of leaflets secured to the frame, each leaflet having: a leaflet first face and a leaflet second face opposing the leaflet first face, a free edge defining a free edge midpoint, and an opposing cusp edge defining a cusp edge midpoint and first and second leaflet body sidelines, each leaflet body sideline extending from the cusp edge midpoint to the free edge, wherein in the radially expanded state of the frame, the leaflet has a first portion and a second portion, the first portion having a concave surface at the first face thereof, and wherein in the radially expanded state of the frame, the second portion extends from the first portion and defines a convex surface at the first face thereof between the first portion and the cusp edge midpoint.

Description

LEAFLETS FOR PROSTHETIC VALVESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 624,869, filed January 25, 2024, which is incorporated by reference herein.FIELD

[0002] The invention relates generally to the field of 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 valve over a catheter and implanting it over the native malfunctioning valve, have been developed over the years.

[0004] Different types of prosthetic 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, toward 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.

[0005] A prosthetic valve conventionally includes a circumferential frame that can be a metallic frame configured to transition between compressed and expanded states, and soft components sutured thereto, such as a leaflet assembly composed of a plurality of leaflets attached to the frame via a plurality of commissure assemblies, and configured to regulate blood flow through the prosthetic valve, as well as a skirt that can prevent perivalvular leakage as further serve as an intermediate means of attachment of the leaflet assembly, along a lower scalloped edge thereof, to the frame. The average human heart beats about 100,000 times perday. Thus, such soft components may be subject to wear due to ongoing movement thereof relative to the frame, as the leaflets move between open and closed positions during systolic and diastolic phases of the blood flow through the valve.

[0006] The leaflets can include tabs at both ends, such that two tabs of each two adjacent leaflets are secured to each other to form a commissure assembly by which they are coupled to the frame. Conventional commissure assemblies are formed such that the portions of the leaflets in the vicinity of the frame, e.g. in or in close proximity to the commissure assemblies, are pressed against each other both in their open and closed positions. This direct contact of these portions of the leaflets can promote tissue overgrowth or pannus formation while the prosthetic valve is implanted within a patient's body, which in turn will result in a relatively rigid region of the leaflets that extends radially inward over time, and may limit the effective orifice area (EOA) of the valve in the open position of the leaflets.

[0007] Another drawback of some prosthetic valves is that conventional leaflets are typically designed as flattenable components that assume a somewhat folded configuration when attached to the frame, but can be unbent and flattened when placed on a flat plane, for example prior to prosthetic valve assembly. It has been observed that lateral folds may be formed across the leaflets in their open position, which can result in flow separation due to excessive momentum loss immediately after flowing past the fold. This disrupts the flow with turbulence and flow eddies, which cause the free ends of the leaflets to flutter. The stresses of such flutter can lead to fatigue failure over time. Another drawback associated with utilization of flattenable leaflets relates to their limited robustness to geometrical changes of the frame, as their design and dimensions are adapted to provide adequate EOA in their open position and proper sealing by coapting against each other in their closed position, in a relatively limited geometry and size of the prosthetic valve.SUMMARY

[0008] Accordingly, it is a principal object of the present invention to overcome at least some of the disadvantages of prior art prosthetic valves.

[0009] In some examples, a prosthetic valve is provided, the prosthetic valve comprising: a frame having an inflow end and an outflow end, wherein the frame is movable between a radially compressed and a radially expanded state; and a plurality of leaflets.

[0010] hi some examples, each leaflet has: a leaflet first face and a leaflet second face opposing the leaflet first face, a free edge defining a free edge midpoint, and an opposing cuspedge, the cusp edge defining a cusp edge midpoint and first and second leaflet body sidelines, each leaflet body sideline extending from the cusp edge midpoint to the free edge.

[0011] In some examples, in the radially expanded state of the frame, the leaflet has a first portion and a second portion, the first portion having a concave surface at the first face thereof.

[0012] In some examples, in the radially expanded state of the frame, the second portion extends from the first portion and defines a convex surface at the first face thereof between the first portion and the cusp edge midpoint.

[0013] In some examples, for each of the plurality of leaflets, the second portion of the leaflet, at the first face thereof, is secured at a predetermined height level of the frame, wherein, for each of the plurality of leaflets, each leaflet body sideline extends past the predetermined height level of the frame in the direction of the inflow end of the frame.

[0014] In some examples, for each of the plurality of leaflets, an apex of the second face extends past the predetermined height level of the frame in the direction of the inflow end.

[0015] In some examples, in the radially expanded state of the frame the cusp edge midpoint is oriented towards the outflow end of the frame.

[0016] In some examples, each of the cusp edge midpoint and the free edge is oriented towards the outflow end of the frame.

[0017] In some examples, for each of the plurality of leaflets, the leaflet second face, at the cusp edge midpoint, is secured at a predetermined height level of the frame, wherein, for each of the plurality of leaflets, each leaflet body sideline extends past the predetermined height level of the frame in the direction of the inflow end of the frame.

[0018] In some examples, for each of the plurality of leaflets, an apex of the second face extends past the predetermined height level of the frame in the direction of the inflow end.

[0019] In some examples, for each of the plurality of leaflets, the leaflet, at the cusp edge midpoint, is secured at a predetermined height level of the frame.

[0020] In some examples, for each of the plurality of leaflets, each leaflet body sideline extends past the predetermined height level of the frame in the direction of the inflow end of the frame.

[0021] In some examples, a prosthetic valve can include any of the features recited in Examples 1-61 below.

[0022] Additional features and advantages of the invention will become apparent from the following drawings and description.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which thisinvention pertains. In case of conflict, the patent specification, including definitions, governs. As used herein, the articles "a" and "an" mean "at least one" or "one or more" unless the context clearly dictates otherwise. As utilized herein, "and / or" means any one or more of the items in the list joined by "and / or". As an example, "x and / or y" means any element of the three-element set { (x), (y), (x, y) } . In other words, "x and / or y" means "one or both of x and y". As another example, "x, y, and / or z" means any element of the seven-element set { (x), (y), (z), (x, y), (x, z), (y, z), (x, y, z)}. In other words, "x, y and / or z" means "one or more of x, y and z".

[0024] Further, unless expressly stated to the contrary, "or" refers to an inclusive or and not to an exclusive or. For example, a condition A or B is satisfied by anyone of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present).

[0025] The various innovations 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 DRAWINGS

[0026] For a better understanding of the invention and to show how the same may be carried into effect, reference will now be made, purely by way of example, to the accompanying drawings.

[0027] With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred examples of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how several forms of the invention may be embodied in practice. In the accompanying drawings:

[0028] Figs. 1A - IE illustrate various high-level views of a prior art prosthetic valve.

[0029] Figs. 2A - 2C illustrate various high-level views a first leaflet, in accordance with some examples of the disclosure.

[0030] Fig. 2D illustrates three of the leaflets of Figs. 2A - 2C in a tricuspid configuration.

[0031] Figs. 2E - 2G illustrate cross-sectional views of a portion the first leaflet of Figs. 2A - 2C in various positions.

[0032] Figs. 3A - 3B illustrate various high-level views of a second leaflet, in accordance with some examples of the disclosure.

[0033] Fig. 4 illustrates an exemplary delivery apparatus carrying a balloon expandable prosthetic valve.

[0034] Fig. 5 illustrates a high-level view of a new prosthetic valve implanted within a previously implanted host prosthetic valve, utilizing the prior art prosthetic valve of Figs. 1A - IF.

[0035] Fig. 6 illustrates a high-level view of a new prosthetic valve implanted within a previously implanted host prosthetic valve, utilizing the leaflets of Figs. 2 A - 2G.DETAILED DESCRIPTION

[0036] 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.

[0037] 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 inconjunction 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.

[0038] 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. 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.

[0039] 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. Additionally, the terms "has", "exhibits" or "includes" means "comprises".

[0040] As used herein, the terms "integrally formed" and "unitary construction" refer to a construction that does not include any welds, fasteners, or other means for securing separately formed pieces of material to each other.

[0041] Figs. 1A - IB illustrate a high-level perspective view of an exemplary prior art prosthetic heart valve 10. 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 valves can be crimped on or retained by a deliver}' apparatus 400 (shown for example in Fig. 4) 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. A prior artprosthetic valve 10 or any other prosthetic valve of the current disclosure 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.

[0042] It is understood that the prosthetic valves disclosed herein may be used with a variety of 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. Self-expandable valves include a frame that is shapeset 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 and U.S. Provisional Application No. 63 / 085,947, filed September 30, 2020, 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.

[0043] The prosthetic valve 10 has an inflow end 14 and an outflow end 16. In some instances, the inflow end 14 is the distal end of the prosthetic valve 10, and the outflow end 16 is the proximal end of the prosthetic valve 10. Alternatively, depending for example on the delivery approach of the valve, the inflow end can be the proximal end of the prosthetic valve, and the outflow end can be the distal end of the prosthetic valve.

[0044] 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.

[0045] 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.

[0046] 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 10, for example between the valve's central axis 15 and the outflow end 16.

[0047] The term "inflow", as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 10, for example between inflow end 14 and a central axis 15 of the valve 10.

[0048] 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.

[0049] The terms "longitudinal" and "axial", as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0050] The prosthetic valve 10 comprises an annular frame 12 movable between a radially compressed state and a radially expanded state, and a leaflet assembly 20 mounted within the frame 12. The frame 12 can be made of various suitable materials, including plastically- deformable materials such as, but not limited to, stainless steel, a nickel based alloy (e.g., a cobalt-chromium or a nickel-cobalt-chromium alloy such as MP35N alloy), polymers, or combinations thereof. When constructed of a plastically-deformable materials, the frame 12 can be crimped to a radially compressed state on a balloon catheter (not shown), and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. Alternatively or additionally, the frame 12 can be made of shape-memory materials such as, but not limited to, nickel titanium alloy (e.g., Nitinol). When constructed of a shape-memory material, the frame 12 can be crimped to a radially compressed state and restrained in the compressed state by insertion into an outer delivery shaft or equivalent mechanism of a delivery apparatus 400.

[0051] In the example illustrated in Figs. 1A - IB, the frame 12 is an annular, stent-like structure comprising a plurality of intersecting struts 30, and defining central axis 15 of the prosthetic valve 10. The frame 12 defines a frame inner surface 40 facing the central axis 15, and an opposite frame outer surface 42 facing away from the central axis 15, for example facing the surrounding anatomy, including annular and blood vessel walls, when implanted in a patient's body. In this application, the term "strut" 30 encompasses vertical struts, angled or curved struts, 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 strut 30 may be any elongated member or portion of the frame 12. The frame 12 can have one or moremultiple rows of cells 21 defined by intersecting struts 30. The frame 12 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 14 to the outflow end 16 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.

[0052] Struts 30 comprise angled struts 32, and optionally vertical struts 34. The term "vertical strut" refers to a strut that generally extends in an axial direction, while the term "angled strut" generally refers to a strut that can extend at an angle relative to an axial line intersecting therewith along a plane defined by the frame 12. It is to be understood that the term "angled strut" encompasses both linear angled struts and curved struts. The exemplary frame 12 of the prosthetic valve 10 illustrated in Figs. 1A - IB comprises a plurality of angled struts 32 and at least two types of vertical struts 34, namely outflow vertical struts 34a formed along the uppermost row of cells 21 (i.e., adjacent outflow end 16), and inflow vertical struts 34b formed along the lowermost row of cells 21 (i.e., adjacent inflow end 14).

[0053] Two or more struts 30 can intersect at junctions 18, which can be equally or unequally spaced apart from each other. The struts 30 may be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 12 can be 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.

[0054] Fig. 4 shows a prosthetic delivery apparatus 400 in accordance with some examples. Deliver}' apparatus 400 comprises a handle 410 and a delivery shaft 420, and carries a prosthetic heart valve 10. In some examples, delivery apparatus 400 further comprises an outer shaft 430. In some examples, delivery apparatus 400 further comprises an inflatable medical balloon 440 and a catheter 450. In some examples, delivery apparatus 400 further comprises a nosecone 460.

[0055] In some examples (not shown), handle 410 further comprises a fluid port. In some examples (not shown), handle 410 further comprises an adjustment member, such as a rotatable knob, optionally coupled to a pull wire (not shown) extending distally from handle 410 through delivery shaft 420. In some examples, catheter 450 extends distally beyond outer shaft 430 and delivery shaft 420, and through inflatable medical balloon 440. In some examples, nosecone 460 is secured to a distal end of inflatable medical balloon 440 and is optionally mounted on, or coupled to, catheter 450.

[0056] In some examples, catheter 450 is in fluid communication with inflatable medical balloon 440. In such an embodiment, fluid can be injected through catheter 450 to inflateinflatable medical balloon 440, thus expanding and deploying prosthetic heart valve 10, as will be described below. In some examples, inflatable medical balloon 440 is not provided, and prosthetic heart valve 10 is expanded using mechanical mechanisms, as will be described below.

[0057] Delivery shaft 420, outer shaft 430, inflatable medical balloon 440 and catheter 450 can be formed from any of various suitable materials, such as nylon, braided stainless steel wires, or a polyether block amide (commercially available as Pebax®). In some examples, delivery shaft 420 and outer shaft 430 have longitudinal sections formed from different materials in order to vary the flexibility of the shafts along their lengths. In some examples, catheter 450 has an inner liner or layer formed of Teflon® to minimize sliding friction with a guide wire (not shown). In some examples, delivery shaft 420 and outer shaft 430 are axially and / or rotatably movable relative to each other and / or handle 410.

[0058] In operation, a user holds handle 410 and maneuvers delivery shaft 420 such that prosthetic heart valve 10 and inflatable medical balloon 440 are inserted into a patient lumen 470 and positioned at a desired implantation site. In some examples, during delivery, prosthetic heart valve 10 is secured within delivery shaft 420 in a crimped state. In some examples, delivery shaft 420 is maneuvered along with outer shaft 430. In an embodiment where a mechanical mechanism is provided instead of inflatable medical balloon 440, as described above, the mechanical mechanism is inserted into patient lumen 470 along with prosthetic heart valve 10.

[0059] hi some examples, during delivery of prosthetic heart valve 10, handle 410 is maneuvered by an operator (e.g., a clinician or a surgeon) to axially advance or retract components of delivery apparatus 400, such as nosecone 460, delivery shaft 420 and / or outer shaft 430, through the patient's vasculature. In some examples, handle 410 comprises one or more operating interfaces, such as steerable or rotatable adjustment knobs, levers, sliders, buttons (not shown) and other actuating mechanisms, which are operatively connected to different components of delivery apparatus 400 and configured to produce axial movement of delivery apparatus 400 in the proximal and distal directions. In an embodiment where a rotatable knob is provided, and operatively coupled to a pull wire, rotating the rotatable knob increases or decreases the tension in the pull wire, thereby adjusting the curvature of delivery shaft 420 to guide prosthetic heart valve 10 to the desired location.

[0060] Delivery apparatus 400 can be utilized, for example, to deliver prosthetic heart valve 10 for mounting against the aortic annulus, the mitral annulus or any other native annulus. In some examples (not shown), a pusher is further provided, the pusher arranged to pushprosthetic heart valve 10 out of delivery shaft 420. In one further embodiment, prosthetic heart valve 10 is crimped over a portion of catheter 450, proximal to inflatable medical balloon 440, or such that only a distal portion of prosthetic heart valve 10 is crimped over inflatable medical balloon 440, so as to reduce the overall profile in a crimped state during delivery. In such an embodiment, the pusher can be utilized to push prosthetic heart valve 10 to extend entirely over the balloon upon reaching the site of implantation, prior to balloon inflation.

[0061] Initially, inflatable medical balloon 440 is in a deflated state and prosthetic heart valve 10 is in a compressed state. In some examples, prosthetic heart valve 10 and inflatable medical balloon 440 are initially retained within outer shaft 430, and once inflatable medical balloon 440 and prosthetic heart valve 10 are positioned at the desired implantation site in patient lumen 470 they are pushed out of outer shaft 430 and / or outer shaft 430 is pulled back therefrom. In some examples, a distal end of outer shaft 430 extends over prosthetic heart valve 10 and contacts nosecone 460 in a delivery configuration (not shown) of prosthetic heart valve 10. Thus, in such an embodiment, the distal end of outer shaft 430 serves as a delivery capsule that contains, or houses, prosthetic heart valve 10 in a radially compressed or radially compressed state for delivery through the patient's vasculature. In some examples, outer shaft 430 and delivery shaft 420 are configured to be axially movable relative to each other, such that a proximally oriented movement of outer shaft 430 relative to delivery shaft 420, or a distally oriented movement of delivery shaft 420 relative to outer shaft 430, removes prosthetic heart valve 10 and inflatable medical balloon 440 from the confines of outer shaft 430. In an alternative embodiment, prosthetic heart valve 10 is not housed within outer shaft 430 during delivery and in such an embodiment outer shaft 430 is optionally not provided.

[0062] After positioning prosthetic heart valve 10 at the desired implantation site, an inflation fluid (not shown) is injected into inflatable medical balloon 440. As the inflation fluid fills inflatable medical balloon 440, inflatable medical balloon 440 is inflated, thereby causing prosthetic heart valve 10 to expand into an expanded state. In some examples, the expanded state includes a range of diameters to which prosthetic heart valve 10 can 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 a radially compressed, or crimped state, and a maximally expanded state.

[0063] In an embodiment where inflatable medical balloon 440 is replaced with a mechanical mechanism, prosthetic heart valve 10 is expanded utilizing the mechanical mechanism. In some examples (not shown), where the frame of prosthetic heart valve 10 is constructed with hingeably connected struts, a differential lateral force is provided to prostheticheart valve 10 to open prosthetic heart valve 10 to an expanded state, as known to those skilled in the art. Alternatively, in an embodiment where prosthetic heart valve 10 comprises a selfexpandable frame, as described above, prosthetic heart valve 10 is initially crimpled within outer shaft 430 and expands when released therefrom.

[0064] The leaflet assembly 20 comprises a plurality of leaflets 50 (e.g., three leaflets), positioned at least partially within the frame 12, and configured to regulate flow of blood through the prosthetic valve 10 from the inflow end 14 to the outflow end 16. While three leaflets 50 arranged to collapse in a tricuspid arrangement, are shown in the exemplary implementation illustrated in Fig. 1 A, it will be clear that a prosthetic valve 10 can include any other number of leaflets 50. The leaflets 50 are made of a flexible material, derived from biological materials (e.g., bovine pericardium or pericardium from other sources), biocompatible synthetic materials, or other suitable materials as known in the art and described, for example, in U.S. Pat. Nos. 6,730,118, 6,767,362 and 6,908,481, which are incorporated by reference herein.

[0065] Each leaflet 50 has a rounded cusp edge 56 opposite a free edge 52, and a pair of generally oppositely-directed tabs 62 separating the cusp edge 56 and the free edge 52. The cusp edge 56 forms a single scallop and defines a cusp edge midpoint 58, opposite to a free edge midpoint 54 defined by the corresponding free edge 52.

[0066] In some examples, a leaflet body 60 is defined as the portion of the leaflet 50 that extends between the cusp edge 56, tabs 62, and free edge 52. That is to say, leaflet body 60 does not include the tabs 62. Each leaflet body 60 defines two leaflet body sidelines 66, each extending from the cusp edge midpoint 58 to the free edge 52.

[0067] The leaflet 50 defines a leaflet first face 68, that can be also referred to as a leaflet outer face, facing away from the central axis 15 when the leaflet assembly 20 is mounted in the frame 12, and a leaflet second face 70, that can be also referred to as a leaflet inner face, facing toward central axis 15 and toward the other leaflets 50 of the leaflet assembly 20 shown in Figs. 1 A - IB. Any of the leaflet first face 68 and / or second face 70 is a face defined over the leaflets body 60 and its tabs 62.

[0068] When the leaflets 50 are coupled to the frame and to each other, the lower edge of the resulting leaflet assembly 20 desirably has a curved scalloped shape. By forming the leaflets with this scalloped geometry, stresses on the leaflets 50 are reduced which, in turn, improves durability of the valve. The scalloped geometry also reduces the amount of tissue material used to form the leaflet structure, thereby allowing a smaller, more even crimped profile at the inflow end of the valve.

[0069] Responsive to an increase in pressure at the inflow end 14 of frame 12, for example during the systole, leaflets 50 transition to an open position, thereby allowing blood to flow therethrough. Responsive to a decrease in pressure at the inflow end 14 of frame 12, for example during the diastole, leaflets 50 transition to a closed position. In the closed position, the leaflets 50 define a non-planar coaptation plane (not annotated) when their free edges 52 co-apt with each other to seal blood flow through the prosthetic valve 10. Leaflets 50 can be secured to one another at their tabs 62 to form commissure assemblies 22 of the leaflet assembly 20, which can be secured, directly or indirectly, to structural elements connected to the frame 12 or embedded therein, such as commissure posts or commissure windows 28. When secured to two other leaflets 50 to form leaflet assembly 20, the cusp edges 56 of the leaflets 50 collectively form the scalloped line of the leaflet assembly 20.

[0070] In some examples, at least some (e.g., three) of the outflow vertical struts 34a can be commissure support struts that can define axially extending window frame portions, also termed commissure windows 28. As shown in Figs. 1A - IB, the commissure window 28 can be configured to receive a corresponding commissure assembly 22. For example, the tabs 62 of a commissure assembly 22 can be passed through the commissure window 28 outward along the radial direction of the frame 12 in order to secure the commissure assembly 22 to the frame 12.

[0071] Various configurations are known in the art by which commissure assemblies may be formed and coupled to a frame 12, some of which can include an outer wedge inserted into between the tabs once they are passed to the radially-outer side of the commissure window. The outer wedge can increase a width of the portion of the commissure assembly extending out of the commissure window (radially away from central axis 15) such that this outer portion of the commissure assembly cannot pass back through the commissure window.

[0072] While the commissure window 28 is illustrated in Figs. 1A - IB as an opening formed within an outflow vertical strut 34a of the frame 12, it is to be understood that such commissure windows can be similarly formed as part of other components attached to the frame 12, such as actuators of mechanically expandable prosthetic valves or other types of structural posts, and that other commissure assembly configuration can be formed without wedge members, for example by wrapping or otherwise suturing portions of the tabs to or around struts or other posts attached to the frame. Further details regarding prosthetic valves, including the manner in which commissures may be mounted to their frames, are described in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,252,202, and 9,393,110; U.S. Publication Nos. 2018 / 0325665, 2019 / 0105153, U.S. Application Nos. 62 / 869,948 and62 / 813,643; and PCT Application No. PCT / US2019 / 61392, all of which documents are incorporated herein by reference. Any of the techniques and mechanisms disclosed in the prior documents can be used to connect commissure assemblies 22, directly or indirectly, to the frame 12.

[0073] The prosthetic valve 10 can also include one or more skirts or sealing members. For example, the prosthetic valve 10 can include an inner skirt 72 mounted on the frame inner surface 40 and / or an outer skirt 80 mounted on the frame outer surface 42 (shown for example in Figs. 5 - 6). The inner skirt 72 can be a circumferential inner skirt that spans an entire circumference of the frame inner surface 40, having a skirt outer surface 74 facing the frame 12 and a skirt inner surface 76 facing central axis 15. The inner skirt 72 can function as a sealing member to prevent or decrease perivalvular leakage (e.g., when the prosthetic valve is placed at the implantation site) and as an attachment surface to anchor a portion of the leaflets 50 to the frame 12. In particular examples, the cusp edges 56 can be sutured to the inner skirt 72 along scallop line 78, which in turn can be sutured to selected struts of the frame. Fig. IB does not show the inner skirt 72 for clarity. It is noted that the inner skirt 72 is not required, and the leaflets 50 can be sutured to either an outer skirt or directly to the frame 12.

[0074] In order to facilitate the securing of the leaflets 50 to the inner skirt 72, or alternatively to the outer skirt or frame 12, leaflet first face 68 is curved outwards in the vicinity of cusp edge midpoint 58 such that a portion 69 of the leaflet first face 68 faces the frame 12, thereby presenting a larger surface area for connected the leaflet 50 to the inner skirt 72, the outer skirt, or the frame 12. The flat shape of portion 69 can more clearly be seen in Figs. 1C - IE which show cross-sectional views of a leaflet 50 against the frame 12 (inner skirt 72 not shown for clarity) in different positions. The cross-sectional view is taken along line 55 extending through a leaflet 50 shown in Fig. IB.

[0075] Fig. 1C shows a cross-sectional view of the leaflet 50 in a closed state, when the frame 12 is in a radially expanded state. Fig. ID shows a cross-sectional view of the leaflet 50 in an open state, when the frame 12 is in the radially expanded state. The height Hl of the frame 12 in the radially expanded state is shown in Figs. 1C - ID. Fig. IE shows a cross- sectional view of the leaflet 50, when the frame 12 is in a radially compressed state, such as during delivery to the site of implantation. The height Hl' of the frame 12 in the radially compressed state is shown in Fig. IE. In some examples, as shown in Fig. ID,

[0076] hi some examples, free edge 52 of the leaflet 50 does not reach outflow end 16, thereby leaving space for a catheter to be passed through the frame 12. The distance between free edge 52 and outflow end 16 is denoted S. In some examples, free edge 52 is at least 2 mmaway from outflow end 16. In some instances, it may be necessary to implant a second prosthetic valve within a previously-implanted prosthetic valve in what is known as a valvein-valve (VIV) procedure. Such a procedure can be used to augment or replace a previously- implanted valve (e.g., if the previously-implanted valve is failing or otherwise compromised). Implantation of the second prosthetic valve or “guest valve” within the first prosthetic valve or “host valve” can be challenging with smaller diameter valves because it can be difficult to properly align and orient the guest valve within the host valve while maintaining access to the coronary ostia. The configuration leaflets 50, where free edges 52 do not reach outflow end 16 can retain access to the coronary ostia regardless of the positioning of the guest valve within the host valve.

[0077] An outer skirt can function as a sealing member by sealing against the tissue of the native valve annulus and helping to reduce paravalvular leakage past the prosthetic valve 10. The inner and outer skirts can be formed from any of various suitable biocompatible materials, including any of various synthetic materials (e.g., PET) or natural tissue (e.g., pericardial tissue). The inner and outer skirts can be mounted to the frame using sutures, an adhesive, welding, and / or other means for attaching the skirts to the frame. Further details regarding the inner and outer skirts and techniques for assembling the leaflets to the inner skirt and assembling the skirts on the frame are disclosed in U.S. Provisional Application No. 62 / 854,702, U.S. Provisional Application No. 62 / 797,837 and U.S. Patent Application Publication No. 2019 / 0192296, each of which is incorporated herein by reference.

[0078] As mentioned above, a leaflet 50 is made of a flexible material that can be derived from a biological materials (e.g., pericardial tissue) or a bio-compatible synthetic material. For example, a portion of pericardium can be flattened over a flat surface and cut to form a leaflet 50. The cut portion of the pericardium is then bent such that the free edge 52 becomes curved inwards, approximating free edge midpoint 54 toward central axis 15, such that the distance between the tabs 62 is reduced. Although the region around free edge midpoint 54 becomes curved, the rest of free edge 52 can remain generally straight. Each leaflet 50 is flattenable, i.e. it can be unbent and flattened.

[0079] In order to allow the leaflets 50 to open against the frame 12 (as illustrated in Fig. ID), such as during systole, a height Hl of the frame 12, defined between the inflow end 14 and the outflow end 16, should be greater than the distance between free edge midpoint 54 and cusp edge midpoint 58, when measured along leaflet first face 68, denoted L in Fig. IB. In that case, there will be sufficient support for the leaflet 50 when fully spread against the frame 12. However, this requires that the height Hl of the frame 12 be sufficiently large.

[0080] As described above, the frame 12 is advanced towards the implantation site in a radially compressed state. Upon arrival at the implantation site, the frame 12 is then expanded to a radially expanded state. During radial expansion, the frame 12 foreshortens in a manner that approximates the inflow end 14 and outflow end 16 to each other. Thus, height Hl' of the frame 12 in the radially compressed state is even greater than height Hl of the frame 12 in the radially expanded state. However, the frame 12 is a rigid device, and a greater height Hl' makes it more difficult to advance to the implantation site through the tortuous vasculature.

[0081] Figs. 2A - 2C illustrate various high-level perspective views of a leaflet 100 for a leaflet assembly 110 of a prosthetic valve, in accordance with some examples. In some examples, leaflet 100 is made of a flexible material, derived from biological materials (e.g., bovine pericardium or pericardium from other sources), bio-compatible synthetic materials, or other suitable materials as known in the art and described, for example, in U.S. Pat. Nos. 6,730,118, 6,767,362 and 6,908,481, the entire contents of each of which are incorporated by reference herein.

[0082] Similar to leaflet 50 described above, with like reference numerals referring to like portions of the leaflet, leaflet 100 has: a leaflet first face 168; a leaflet second face 170 opposing leaflet first face 168; a free edge 152 extending between tabs 162 and defining a free edge midpoint 154; a cusp edge 156 opposing free edge 152 and defining a cusp edge midpoint 158 opposing free edge midpoint 154; a leaflet body 160 defined between the cusp edge 156, tabs 162 and free edge 152; a first leaflet body sideline 166a extending from the cusp edge midpoint 158 to the free edge 152; and a second leaflet body sideline 166b opposing first leaflet body sideline 166a. The term "free edge", as used herein, means an edge which is not connected to a frame, thereby allowing the free edge to move back and forth as blood flows through leaflet assembly 110 across leaflet 100.

[0083] In some examples, leaflet 100 is not flattenable. The term "not flattenable", as used herein, means that it cannot be flattened. In some examples, if an attempt is made to straighten out the curve of free edge 152 of leaflet 100, the curve will not be able to be completely straightened such that leaflet 100 becomes flat. In some examples, if an attempt is made to straighten out the curves of first leaflet body sideline 166a and second leaflet body sideline 166b, the curves will not be able to be completely straightened such that leaflet 100 becomes flat. In some examples, each of first face 168 and second face 170 of leaflet 100 is a non- developable surface. Thus, first face 168 and second face 170 cannot be flattened. This is in contrast to leaflets 50, described above, that are flattenable.

[0084] In some examples, a first portion 180 of leaflet 100 is curved from first leaflet body sideline 166a to second leaflet body sideline 166b. In such an example, any cross-section of first portion 180 extending from first leaflet body sideline 166a to second leaflet body sideline 166b can define a curve. In some examples, the curve defined by each cross-section of first portion 180 extending from first leaflet body sideline 166a to second leaflet body sideline 166b exhibits a generally parabolic shape. In some examples, the curve of first portion 180 from first leaflet body sideline 166a to second leaflet body sideline 166b forms a predetermined section of an ellipsoid.

[0085] In some examples, leaflet first face 168 of the first portion 180 of leaflet 100 is a concave surface. In some examples, leaflet first face 168 of the first portion 180 is a concave surface whose first end is defined by first leaflet body sideline 166a and whose second end is defined by second leaflet body sideline 166b. The ends of a concave surface, as described herein, are defined such that the concavity of the surface extends from the first end to the second end thereof. In some examples, the concavity of leaflet first face 168 of the first portion 180 is three-dimensional, such that the concave surface is defined by a first concave cross-section extending from first leaflet body sideline 166a to second leaflet body sideline 166b and a second concave cross-section extending from free edge 152 to an apex 182 of leaflet first face 168, apex 182 defining an end 182 of first portion 180.

[0086] In some examples, leaflet first face 168 of a second portion 184 of leaflet 100 is a convex surface, where the second portion 184 extends from the first portion 180 to cusp edge midpoint 158. Thus, leaflet first face 168 of the second portion 184 presents an increased surface area to a frame 102 to be attached thereto (as shown in Fig. 2E), or to an inner or outer skirt (not shown for simplicity). In some examples, the frame 102 is in all respects similar to the frame 12 described above, with the exception of its height, as described below.

[0087] In some examples, leaflet second face 170 of the first portion 180 is a convex surface. In some examples, leaflet second face 170 of the first portion 180 is a convex surface whose first end is defined by first leaflet body sideline 166a and whose second end is defined by second leaflet body sideline 166b. The ends of a convex surface, as described herein, are defined such that the convexity of the surface extends form the first end to the second end thereof. In some examples, the convexity of leaflet second face 170 is three-dimensional, such that the concave surface defined by a first concave cross-section extending from first leaflet body sideline 166a to second leaflet body sideline 166b and a second concave cross-section extending from free edge 152 to the apex 182 of the leaflet first face 168.

[0088] In some examples, leaflet second face 170 of the second portion 184 of leaflet 100 is a concave surface.

[0089] In some examples, the distance between first leaflet body sideline 166a and second leaflet body sideline 166b decreases from free edge 152 to cusp edge midpoint 158, i.e. the distance is greater at free edge 152 than at cusp edge midpoint 158. In some examples, this distance is measured via the shortest path along leaflet first face 168 or leaflet second face 170. In some examples, this distance is measured via the shortest direct line from first leaflet body sideline 166a to second leaflet body sideline 166b.

[0090] hi some examples, each of first leaflet body sideline 166a and second leaflet body sideline 166b have an undulating shape, as described above. In some examples, first leaflet body sideline 166a and second leaflet body sideline 166b meet in cusp edge midpoint 158. In some examples, cusp edge midpoint 158 is defined by the meeting point of first leaflet body sideline 166a and second leaflet body sideline 166b.

[0091] Fig. 2D illustrates three of the leaflets of Figs. 2A - 2C in a tricuspid configuration, in a closed state, as described above in relation to Figs. 1A - IB. As described above, responsive to an increase in pressure, for example during the systole, leaflets 100 transition to an open position, thereby allowing blood to flow therethrough. Responsive to a decrease in pressure, for example during the diastole, leaflets 100 transition to a closed position. In the closed position, the leaflets 100 define a non-planar coaptation plane (not annotated) when their free edges 152 co-apt with each other to seal blood flow through the prosthetic valve (not shown for simplicity). A length L of a leaflet 100 is shown in Fig. 2D, extending along the leaflet first face 168.

[0092] Fig. 2E illustrates a cross-sectional view of a leaflet 100 in the closed state, in relation to a frame 102 when the frame 102 is in a radially expanded state. Fig. 2F illustrates a cross-sectional view of the leaflet 100 in the open state, in relation to the frame 102 when the frame 102 is in the radially expanded state. A height H2 of the frame 102 in the radially expanded state is shown in Figs. 2E and 2F. Fig. 2G illustrates a cross-sectional view of the leaflet 100 in relation to a frame 102, when the frame 102 is in a radially compressed state. A height H2’ of the frame 102 in the radially compressed state is shown in Fig. 2G. Heights H2 and H2' are each defined between inflow end 114 and outflow end 116. The cross-sectional views are each taken along line 155 extending through a leaflet 100 shown in Fig. 2D.

[0093] The leaflet 100 faces a frame inner surface 140 (opposing a frame outer surface 142) and is secured to the frame 102 near the cusp edge midpoint 158. The leaflet 100 can be attached to the frame 102, or attached to an inner skirt or outer skirt secured to the frame 102(not shown). The height at which the leaflet 100 is secured to the frame is denoted height 190. In some examples, as shown in Fig. 2E, the apex 182 of the leaflet first face 168 extends away from height 190 towards an outflow end 116 of the frame 102. In some examples, from the apex 182, first portion 180 curves and extends past height 190 in the direction of inflow end 114. In some examples, an apex 192 of leaflet second face 170 extends past height 190 in the direction of inflow end 114. In some examples, the apex 192 is defined on curve 155 described above. In some examples, at least a portion of leaflet body sidelines 166 extends past height 190 in the direction of inflow end 114. In some examples, at least a section of the leaflet 100 extends towards, and past, inflow end 114. In some examples, the apex 192 extends past inflow end 114. In some examples, at least a portion of leaflet body sidelines 166 extends towards, and past, inflow end 114.

[0094] In some examples, a distance DI between the frame 102 and the apex 192 of leaflet second face 170 is at least 10% of a radius of the frame 102, defined between a frame inner face 140 and a central axis 15.

[0095] In Fig. 2E, the difference between the height 190 and the height of apex 192 is denoted A. In some examples, difference A is at least 1 millimeter. In some examples, difference A is at least 3 millimeters. In some examples, difference A is at least 5 millimeters. In some examples, difference A is 5 - 7 millimeters. It is noted that A defines the largest distance between leaflet second face 170 and height 190. As shown in Fig. 2A, leaflet body sidelines 166 are closer to the cusp edge midpoint 158 than apex 192. Thus, the difference between the height of leaflet 100 and height 190 decreases along the curves of leaflet second face 170 and leaflet first face 168. In some examples, the largest difference between the height of the leaflet body sidelines 166 and height 190 is about 2 millimeters less than difference A.

[0096] In Fig. 2E, the difference between the height of inflow end 114 and the height of apex 192 is denoted Y. In some examples, difference Y is at least 1 millimeter. In some examples, difference Y is at least 3 millimeters. In some examples, difference Y is at least 5 millimeters. In some examples, difference Y is 5 - 7 millimeters. In some examples, difference Y is less than 2 millimeters smaller than A. In some examples, difference Y is less than 1 millimeter smaller than A.

[0097] As shown in Fig. 2E, because the leaflet 100 extends past height 190, and optionally past inflow end 114, the height H2 of the frame 102 can be shorter than length L. In some examples, as illustrated in Fig. 2F, free edge 152 of the leaflet 100 does not reach outflow end 116, thereby leaving a space, defined by distance S, for a catheter to be passed through the frame 102, as described above in relation to frame 12.

[0098] In some examples, the height H2 of the frame 102, defined between inflow end 114 and outflow end 116, is at least the size of the shortest distance between free edge midpoint 154 and cusp edge midpoint 158 when the frame 102 is crimped and the leaflet 100 is pressed against the frame 102. Thus, as opposed to the frame 12 whose height Hl in the radially expanded state of the frame 12 needs to be as long as the leaflet 100, the frame 102 can have a height H2 in the expanded state of the frame 102 which is shorter than the length L of the leaflet 100. Thus, height H2 is shorter than height Hl (both in the radially expanded state) and height H2' is shorter than height Hl' (both in the radially compressed state).

[0099] hi some examples, the difference between H2' and H2 is greater than 2* A. In some examples, such a difference allows for leaflet 100 to be fully pressed against the frame 102 when the frame 102 is in the radially compressed state.

[0100] It is noted that H2 can be equal to Hl, and the use of leaflets 100 can inherently provide distance S, which for frame 12 would be provided by lengthening Hl. Similarly, a difference between Hl and H2 that is smaller than the difference described above, while still provided distance S.

[0101] Fig. 3A shows a high-level side view of a leaflet 200. In some examples, leaflet 200 is in all respects similar to leaflet 100, with the exception that apex 182 of the leaflet first face 168 culminates in the cusp edge midpoint 158, and second portion 184 is not provided. Fig. 3B shows a cross-sectional view of a leaflet 200 in the closed state, in relation to a frame 102 when the frame 102 is in a radially expanded state.

[0102] Thus, in some examples, leaflet 200 is curved from a first leaflet body sideline 266a to a second leaflet body sideline 266b. In such an example, any cross-section of leaflet 200 extending from first leaflet body sideline 266a to second leaflet body sideline 266b can define a curve. In some examples, the curve defined by each cross-section of leaflet 200 extending from first leaflet body sideline 266a to second leaflet body sideline 266b exhibits a generally parabolic shape. In some examples, the curve of leaflet 200 from first leaflet body sideline 266a to second leaflet body sideline 266b forms a predetermined section of an ellipsoid.

[0103] In some examples, a leaflet first face 268 is a concave surface. In some examples, leaflet first face 268 is a concave surface whose first end is defined by first leaflet body sideline 266a and whose second end is defined by second leaflet body sideline 266b. The ends of a concave surface, as described herein, are defined such that the concavity of the surface extends from the first end to the second end thereof. In some examples, the concavity of leaflet first face 268 is three-dimensional, such that the concave surface is defined by a first concave cross-section extending from first leaflet body sideline 266a to second leaflet body sideline 266b and a second concave cross-section extending from a free edge 252 to a cusp edge midpoint 258.

[0104] In some examples, a leaflet second face 270 defines a convex surface. In some examples, leaflet second face 270 is a convex surface whose first end is defined by first leaflet body sideline 266a and whose second end is defined by second leaflet body sideline 266b. The ends of a convex surface, as described herein, are defined such that the convexity of the surface extends form the first end to the second end thereof. In some examples, the convexity of leaflet second face 270 is three-dimensional, such that the concave surface defined by a first concave cross-section extending from first leaflet body sideline 266a to second leaflet body sideline 266b and a second concave cross-section extending from free edge 252 to cusp edge midpoint 258.

[0105] In some examples, the distance between first leaflet body sideline 266a and second leaflet body sideline 266b decreases from free edge 252 to cusp edge midpoint 258, i.e. the distance is greater at free edge 252 than at cusp edge midpoint 258. In some examples, this distance is measured via the shortest path along leaflet first face 268 or leaflet second face 270. In some examples, this distance is measured via the shortest direct line from first leaflet body sideline 266a to second leaflet body sideline 266b.

[0106] In some examples, each of first leaflet body sideline 266a and second leaflet body sideline 266b is curved. In some examples, each of first leaflet body sideline 266a and second leaflet body sideline 266b is curved from free edge 252 to a cusp edge midpoint 258 of a cusp edge 256. In some examples, first leaflet body sideline 266a and second leaflet body sideline 266b meet in cusp edge midpoint 258. In some examples, cusp edge midpoint 258 is defined by the meeting point of first leaflet body sideline 266a and second leaflet body sideline 266b. In some examples, first leaflet body sideline 266a and second leaflet body sideline 266b form a continuous curve, with cusp edge midpoint 258 being a local extremum of this curve. In some examples, the ends of the continuous curve are defined by free edge 252.

[0107] In some examples, as shown, the curves of body sidelines 266 begin in a first direction and end in a second direction, the second direction opposing the first direction. For example, the body sidelines 266 begin to extend in the direction of inflow end 114 and towards cusp edge midpoint 258 curve towards outflow end 116. Thus, at cusp edge midpoint 258, leaflet second face 270 faces frame inner face 140 of frame 102, as shown in Fig. 3B, which illustrates a high-level cross-sectional view of a portion of the leaflet 200 and the frame 102 (similar to Fig. 2E). This is opposed to leaflets 50 and 100 where the first face (68, 168) of the leaflet faces frame inner face 140 of frame 102.

[0108] As illustrated, each of the cusp edge midpoint 258 and the free edge 252 of leaflet 200 are oriented towards the outflow end 116 of the frame 102. As shown in relation to the orientation of the frame 102 in FIG. 3B, both the cusp edge midpoint 258 and the free edge 252 face upwards.

[0109] In some examples, a section 269 that is attached to the frame 102 (or to an inner or outer skirt) is generally parallel to the frame 102. In some examples, a length of section 269 that is attached to the frame 102 (or to an inner or outer skirt) is denoted C. In some examples, length C is defined by the width of the suture used for attachment of the leaflet 100. In some examples, length C is 0.05 - 0.1 millimeters.

[0110] In some examples, as described above in relation to leaflets 100, section 269 is secured to the frame 102 at height 190. In some examples, as described above in relation to leaflets 100, leaflet 200 extends from height 190 in the direction of inflow end 114. In some examples, an apex 292 of leaflet second face 270 extends from height 190 in the direction of inflow end 114. In some examples, at least a portion of leaflet body sidelines 266 extends from height 190 in the direction of inflow end 114. In some examples, at least a section of the leaflet 200 extends towards, and past, inflow end 114. In some examples, the apex 292 extends past inflow end 114. In some examples, at least a portion of leaflet body sidelines 266 extends towards, and past, inflow end 114.

[0111] In Fig. 3B, the difference between the height 190 and the height of apex 292 is denoted A. In some examples, difference A is at least 1 millimeter. In some examples, difference A is at least 3 millimeters. In some examples, difference A is at least 5 millimeters. In some examples, difference A is 5 - 7 millimeters. It is noted that A defines the largest distance between leaflet second face 270 and height 190. As shown in Fig. 3A, leaflet body sidelines 266 are closer to the cusp edge midpoint 258 than apex 292. Thus, the difference between the height of leaflet 200 and height 190 decreases along the curves of leaflet second face 270 and leaflet first face 268. In some examples, the largest difference between the height of the leaflet body sidelines 266 and height 190 is about 2 millimeters less than difference A.

[0112] In Fig. 3B, the difference between the height of inflow end 114 and the height of apex 292 is denoted Y. In some examples, difference Y is at least 1 millimeter. In some examples, difference Y is at least 3 millimeters. In some examples, difference Y is at least 5 millimeters. In some examples, difference Y is 5 - 7 millimeters. In some examples, difference Y is less than 2 millimeters smaller than A. In some examples, difference Y is less than 1 millimeter smaller than A.

[0113] In some examples, as described above in relation to leaflets 100, the difference between the height H2' of the frame 102 in the radially compressed state (not shown) and the height H2 of the frame 102 in the radially expanded state is at least 2 time greater than the difference A.

[0114] Fig. 5 illustrates a high-level view of a new prosthetic valve implanted within a previously implanted host prosthetic valve, utilizing the prior art prosthetic valve 10b of Figs. 1A - IF. For an existing implanted prosthetic valve, the valvular structure may naturally degrade over time thereby requiring repair or replacement in order to maintain adequate heart functions. In a Valve-in- Valve (ViV) procedure, a new prosthetic heart valve is mounted within the existing, degrading prosthetic heart valve in order to restore proper function. Fig. 5 illustrates an exemplary prosthetic valve 10b that can be implanted within a previously implanted prosthetic valve 10a (for example, after a ViV procedure).

[0115] In this example, the prosthetic valve 10b is a guest valve or new valve, and the prosthetic valve 10a is the host valve or old valve. In this example, the host prosthetic valve 10a was previously implanted within the orifice of the native heart valve (not shown). Each of the prosthetic valves 10a, 10b can have the general structure of the prosthetic valve 10 described with reference to Figs. 1A - IF, though in some examples, each of the prosthetic valves 10a, 10b can be a different type of prosthetic valve. For example, a balloon expandable guest valve 10b can be implanted inside a previously implanted mechanically expandable or self-expandable host valve 10a.

[0116] During implantation of the prosthetic valve 10b, the prosthetic valve 10b is positioned within a central region defined between the leaflets 50 of the prosthetic valve 10a, which now take the role of host leaflets. The prosthetic valve 10b is then radially expanded against the host leaflets 50a. As illustrated, the radial expansion of the prosthetic valve 10a results in outward displacement of the host leaflets 50a. As further illustrated, the host leaflets 50 are displaced such that the host leaflets 50a are sandwiched between the frame 12b of the guest prosthetic valve 10b and the frame 12a of the host prosthetic valve 10a.

[0117] Thus, the leaflets 50b face a frame inner surface 40b of the frame 12b and the leaflets 50a are positioned between the frame 12b and the frame inner surface 40a of the host frame 12a. As described above, in some examples a distance S is present between: the leaflets 50a and 50b; and the outflow end of the frame 12a and 12b.

[0118] Fig. 6 illustrates a high-level view of a new prosthetic valve implanted within a previously implanted host prosthetic valve, utilizing the leaflets of Figs. 2A - 2G. Fig. 6illustrates an exemplary frame 102b that can be implanted within a previously implanted frame 102a (for example, after a ViV procedure), as described above.

[0119] During implantation, the frame 102b is positioned within a central region defined between the leaflets 100a, which now take the role of host leaflets. The frame 102b is then radially expanded against the host leaflets 100a. As illustrated, the radial expansion of the frame 102a results in outward displacement of the host leaflets 100a. As further illustrated, the host leaflets 100a are displaced such that the host leaflets 100a are sandwiched between the frame 102b and the frame 102a.

[0120] Thus, the leaflets 100b face a frame inner surface 140b of the frame 102b and the leaflets 100a are positioned between the frame 102b and the frame inner surface 140a of the host frame 102a. As described above, in some examples a distance S is present between: the leaflets 100a and 100b; and the outflow end of the frame 102a and 102b. As described above, distance S can be achieved when the height H2 of the frame 102 is equal to the height Hl of the frame 12 due to the shape and configuration of leaflets 100. Similarly, as described above, distance S can be achieved with a small difference between heights H2 and Hl.Additional Examples of the Disclosed Technology

[0121] In view of the above described implementations of the disclosed subject matter, this application discloses the additional examples 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 further examples are further examples also falling within the disclosure of this application.

[0122] Example 1. A prosthetic valve, comprising: a frame having an inflow end and an outflow end, wherein the frame is movable between a radially compressed and a radially expanded state; and a plurality of leaflets secured to the frame, each leaflet having: a leaflet first face and a leaflet second face opposing the leaflet first face, a free edge defining a free edge midpoint, and an opposing cusp edge, the cusp edge defining a cusp edge midpoint and first and second leaflet body sidelines, each leaflet body sideline extending from the cusp edge midpoint to the free edge, wherein in the radially expanded state of the frame, the leaflet has a first portion and a second portion, the first portion having a concave surface at the first face thereof, and wherein in the radially expanded state of the frame, the second portion extends from the first portion and defines a convex surface at the first face thereof between the first portion and the cusp edge midpoint.

[0123] Example 2. The prosthetic valve of any example herein, particularly example 1, wherein, for each of the plurality of leaflets, the second portion of the leaflet, at the first face thereof, faces the frame.

[0124] Example 3. The prosthetic valve of any example herein, particularly example 1 or 2, wherein, for each of the plurality of leaflets, the second portion of the leaflet, at the first face thereof, is secured at a predetermined height level of the frame, and wherein, for each of the plurality of leaflets, each leaflet body sideline extends past the predetermined height level of the frame in the direction of the inflow end of the frame.

[0125] Example 4. The prosthetic valve of any example herein, particularly example 3, wherein, for each of the plurality of leaflets, each leaflet body sideline extends at least 1 millimeter past the predetermined height level of the frame in the direction of the inflow end of the frame.

[0126] Example 5. The prosthetic valve of any example herein, particularly example 3 or 4, wherein, for each of the plurality of leaflets, each leaflet body sideline extends past the inflow end of the frame.

[0127] Example 6. The prosthetic valve of any example herein, particularly example 5, wherein, for each of the plurality of leaflets, each leaflet body sideline extends at least 1 millimeter past the inflow end of the frame.

[0128] Example 7. The prosthetic valve of any example herein, particularly any one of examples 3 - 6, wherein, for each of the plurality of leaflets, an apex of the second face extends past the predetermined height level of the frame in the direction of the inflow end.

[0129] Example 8. The prosthetic valve of any example herein, particularly example 7, wherein, for each of the plurality of leaflets, the apex of the second face extends at least 1 millimeter past the predetermined height level of the frame in the direction of the inflow end of the frame.

[0130] Example 9. The prosthetic valve of any example herein, particularly example 7 or 8, wherein, for each of the plurality of leaflets, the apex of the second face extends past the inflow end of the frame.

[0131] Example 10. The prosthetic valve of any example herein, particularly example 9, wherein, for each of the plurality of leaflets, the apex of the second face extends at least 1 millimeter past the inflow end of the frame.

[0132] Example 11. The prosthetic valve of any example herein, particularly any one of examples 9 - 10, wherein a difference between a height of the frame in the radially compressed state and a height of the frame in the radially expanded state is at least 2 times the value of adistance between the predetermined height level of the frame and the apex of the second face of each of the plurality of leaflets.

[0133] Example 12. The prosthetic valve of any example herein, particularly any one of examples 9 - 11, wherein, for each of the plurality of leaflets, a distance between the frame and the apex of the second face is at least 10% of a radius of the frame.

[0134] Example 13. The prosthetic valve of any example herein, particularly any one of examples 1 - 12, wherein each of the plurality of leaflets is not flattenable.

[0135] Example 14. The prosthetic valve of any example herein, particularly example 13, wherein, for each of the plurality of leaflets, the leaflet first face and the leaflet second face are non-developable surfaces.

[0136] Example 15. The prosthetic valve of any example herein, particularly any one of examples 1 - 14, wherein, for each of the plurality of leaflets, the respective leaflet is curved from the first leaflet body sideline to the second leaflet body sideline.

[0137] Example 16. The prosthetic valve of any example herein, particularly example 15, wherein the curve of each of the plurality of leaflets from the respective first leaflet body sideline to the respective second leaflet body sideline forms a predetermined section of an ellipsoid.

[0138] Example 17. The prosthetic valve of any example herein, particularly any one of examples 1 - 16, wherein each of the plurality of leaflets is curved from the free edge to the second portion.

[0139] Example 18. The prosthetic valve of any example herein, particularly any one of examples 1 - 17, wherein, for each of the plurality of leaflets, a predetermined distance is provided between the free edge of the leaflet and the outflow end of the frame when the frame is in the radially expanded state.

[0140] Example 19. The prosthetic valve of any example herein, particularly example 18, wherein the predetermined distance is at least 2 millimeters.

[0141] Example 20. A prosthetic valve, comprising: a frame having an inflow end and an outflow end, wherein the frame is movable between a radially compressed and a radially expanded state; and a plurality of leaflets secured to the frame, each leaflet having: a leaflet first face and a leaflet second face opposing the leaflet first face, a free edge defining a free edge midpoint, and an opposing cusp edge, the cusp edge defining a cusp edge midpoint and first and second leaflet body sidelines, each leaflet body sideline extending from the cusp edge midpoint to the free edge, wherein in the radially expanded state of the frame the cusp edge midpoint is oriented towards the outflow end of the frame.

[0142] Example 21. The prosthetic valve of any example herein, particularly example 20, wherein each of the cusp edge midpoint and the free edge is oriented towards the outflow end of the frame.

[0143] Example 22. The prosthetic valve of any example herein, particularly example 20 or 21, wherein, for each of the plurality of leaflets, the leaflet second face defines a convex surface from the free edge to the cusp edge midpoint, and wherein a portion of the second face, between an apex thereof and the cusp edge midpoint, faces the frame.

[0144] Example 23. The prosthetic valve of any example herein, particularly example 22, wherein, for each of the plurality of leaflets, the portion of the leaflet second face is generally parallel to the frame.

[0145] Example 24. The prosthetic valve of any example herein, particularly any one of examples 20 - 23, wherein, for each of the plurality of leaflets, the leaflet first face defines a concave surface from the free edge to the cusp edge midpoint.

[0146] Example 25. The prosthetic valve of any example herein, particularly example 20, wherein, wherein, for each of the plurality of leaflets, the leaflet first face defines a concave surface from the free edge to the cusp edge midpoint and the leaflet second face defines a convex surface from the free edge to the cusp edge midpoint, wherein the concave surface and the convex surface meet at the free edge and the cusp edge midpoint.

[0147] Example 26. The prosthetic valve of any example herein, particularly any one of examples 20 - 25, wherein, for each of the plurality of leaflets, the leaflet second face, at the cusp edge midpoint, is secured at a predetermined height level of the frame, and wherein, for each of the plurality of leaflets, each leaflet body sideline extends past the predetermined height level of the frame in the direction of the inflow end of the frame.

[0148] Example 27. The prosthetic valve of any example herein, particularly example 26, wherein, for each of the plurality of leaflets, each leaflet body sideline extends at least 1 millimeter past the predetermined height level of the frame in the direction of the inflow end of the frame.

[0149] Example 28. The prosthetic valve of any example herein, particularly example 27, wherein, for each of the plurality of leaflets, each leaflet body sidelines extends past the inflow end of the frame.

[0150] Example 29. The prosthetic valve of any example herein, particularly example 28, wherein, for each of the plurality of leaflets, each leaflet body sideline extends at least 1 millimeter past the inflow end of the frame.

[0151] Example 30. The prosthetic valve of any example herein, particularly any one of examples 26 - 29, wherein, for each of the plurality of leaflets, an apex of the second face extends past the predetermined height level of the frame in the direction of the inflow end.

[0152] Example 31. The prosthetic valve of any example herein, particularly example 30, wherein, for each of the plurality of leaflets, the apex of the second face extends at least 1 millimeter past the predetermined height level of the frame in the direction of the inflow end of the frame.

[0153] Example 32. The prosthetic valve of any example herein, particularly example 30 or 31, wherein, for each of the plurality of leaflets, the apex of the second face extends past the inflow end of the frame.

[0154] Example 33. The prosthetic valve of any example herein, particularly example 32, wherein, for each of the plurality of leaflets, the apex of the second face extends at least 1 millimeter past the inflow end of the frame.

[0155] Example 34. The prosthetic valve of any example herein, particularly any one of examples 30 - 33, wherein a difference between a height of the frame in the radially compressed state and a height of the frame in the radially expanded state is at least 2 times the value of a distance between the predetermined height level of the frame and the apex of the second face of each of the plurality of leaflets.

[0156] Example 35. The prosthetic valve of any example herein, particularly any one of examples 20 - 34, wherein each of the plurality of leaflets is not flattenable.

[0157] Example 36. The prosthetic valve of any example herein, particularly example 35, wherein, for each of the plurality of leaflets, the leaflet first face and the leaflet second face are non-developable surfaces.

[0158] Example 37. The prosthetic valve of any example herein, particularly any one of examples 20 - 36, wherein, for each of the plurality of leaflets, the respective leaflet is curved from the first leaflet body sideline to the second leaflet body sideline.

[0159] Example 38. The prosthetic valve of any example herein, particularly example 37, wherein the curve of each of the plurality of leaflets from the respective first leaflet body sideline to the respective second leaflet body sideline forms a predetermined section of an ellipsoid.

[0160] Example 39. The prosthetic valve of any example herein, particularly any one of examples 20 - 38, wherein, for each of the plurality of leaflets, a predetermined distance is provided between the free edge of the leaflet and the outflow end of the frame when the frame is in the radially expanded state.

[0161] Example 40. The prosthetic valve of any example herein, particularly example 39, wherein the predetermined distance is at least 2 millimeters.

[0162] Example 41. A prosthetic valve, comprising: a frame having an inflow end and an outflow end, wherein the frame is movable between a radially compressed and a radially expanded state; and a plurality of leaflets secured to the frame, each leaflet having: a leaflet first face and a leaflet second face opposing the leaflet first face, a free edge defining a free edge midpoint, and an opposing cusp edge, the cusp edge defining a cusp edge midpoint and first and second leaflet body sidelines, each leaflet body sideline extending from the cusp edge midpoint to the free edge, wherein, for each of the plurality of leaflets, the leaflet, at the cusp edge midpoint, is secured at a predetermined height level of the frame, and wherein, for each of the plurality of leaflets, each leaflet body sideline extends past the predetermined height level of the frame in the direction of the inflow end of the frame.

[0163] Example 42. The prosthetic valve of any example herein, particularly example 41, wherein, for each of the plurality of leaflets, each leaflet body sideline extends at least 1 millimeter past the predetermined height level of the frame in the direction of the inflow end of the frame.

[0164] Example 43. The prosthetic valve of any example herein, particularly example 42, wherein, for each of the plurality of leaflets, each leaflet body sidelines extends past the inflow end of the frame.

[0165] Example 44. The prosthetic valve of any example herein, particularly example 43, wherein, for each of the plurality of leaflets, each leaflet body sideline extends at least 1 millimeter past the inflow end of the frame.

[0166] Example 45. The prosthetic valve of any example herein, particularly any one of examples 41 - 44, wherein, for each of the plurality of leaflets, an apex of the second face extends past the predetermined height level of the frame in the direction of the inflow end.

[0167] Example 46. The prosthetic valve of any example herein, particularly example 45, wherein, for each of the plurality of leaflets, the apex of the second face extends at least 1 millimeter past the predetermined height level of the frame in the direction of the inflow end of the frame.

[0168] Example 47. The prosthetic valve of any example herein, particularly example 45 or 46, wherein, for each of the plurality of leaflets, the apex of the second face extends past the inflow end of the frame.

[0169] Example 48. The prosthetic valve of any example herein, particularly example 47, wherein, for each of the plurality of leaflets, the apex of the second face extends at least 1 millimeter past the inflow end of the frame.

[0170] Example 49. The prosthetic valve of any example herein, particularly any one of examples 45 - 48, wherein a difference between a height of the frame in the radially compressed state and a height of the frame in the radially expanded state is at least 2 times the value of a distance between the predetermined height level of the frame and the apex of the second face of each of the plurality of leaflets.

[0171] Example 50. The prosthetic valve of any example herein, particularly any one of examples 41 - 49, wherein each of the plurality of leaflets is not flattenable.

[0172] Example 51. The prosthetic valve of any example herein, particularly example 50, wherein, for each of the plurality of leaflets, the leaflet first face and the leaflet second face are non-developable surfaces.

[0173] Example 52. The prosthetic valve of any example herein, particularly any one of examples 41 - 51, wherein, for each of the plurality of leaflets, the respective leaflet is curved from the first leaflet body sideline to the second leaflet body sideline.

[0174] Example 53. The prosthetic valve of any example herein, particularly example 52, wherein the curve of each of the plurality of leaflets from the respective first leaflet body sideline to the respective second leaflet body sideline forms a predetermined section of an ellipsoid.

[0175] Example 54. The prosthetic valve of any example herein, particularly any one of examples 41 - 53, wherein, for each of the plurality of leaflets, a predetermined distance is provided between the free edge of the leaflet and the outflow end of the frame when the frame is in the radially expanded state.

[0176] Example 55. The prosthetic valve of any example herein, particularly example 54, wherein the predetermined distance is at least 2 millimeters.

[0177] Example 56. The prosthetic valve of any example herein, particularly any one of examples 41 - 55, wherein the leaflet has a first portion and a second portion, the first portion having a concave surface at the first face thereof, and wherein the second portion extends from an end of the first portion and defines a convex surface at the first face thereof between the first portion and the cusp edge midpoint.

[0178] Example 57. The prosthetic valve of any example herein, particularly example 56, wherein, for each of the plurality of leaflets, the second portion of the leaflet, at the first face thereof, faces the frame.

[0179] Example 58. The prosthetic valve of any example herein, particularly any one of examples 41 - 55, wherein each of the cusp edge midpoint and the free edge extends towards the outflow end of the frame.

[0180] Example 59. The prosthetic valve of any example herein, particularly example 58, wherein each of the cusp edge midpoint and the free edge extend towards the outflow end of the frame.

[0181] Example 60. The prosthetic valve of any example herein, particularly example 58 or 59, wherein, for each of the plurality of leaflets, the leaflet second face defines a convex surface from the free edge to the cusp edge midpoint, and wherein a portion of the second face, between an apex thereof and the cusp edge midpoint, faces the frame.

[0182] Example 61. The prosthetic valve of any example herein, particularly example 60, wherein, for each of the plurality of leaflets, the portion of the leaflet second face is generally parallel to the frame.

[0183] It is appreciated that certain features of the invention, 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 invention, which are, for brevity, described in the context of a single example, may also be provided separately or in any suitable subcombination or as suitable in any other described example of the invention. No feature described in the context of an example is to be considered an essential feature of that example, unless explicitly specified as such.

[0184] 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 having an inflow end and an outflow end, wherein the frame is movable between a radially compressed and a radially expanded state; and a plurality of leaflets secured to the frame, each leaflet having: a leaflet first face and a leaflet second face opposing the leaflet first face, a free edge defining a free edge midpoint, and an opposing cusp edge, the cusp edge defining a cusp edge midpoint and first and second leaflet body sidelines, each leaflet body sideline extending from the cusp edge midpoint to the free edge, wherein in the radially expanded state of the frame, the leaflet has a first portion and a second portion, the first portion having a concave surface at the first face thereof, and wherein in the radially expanded state of the frame, the second portion extends from the first portion and defines a convex surface at the first face thereof between the first portion and the cusp edge midpoint.

2. The prosthetic valve of claim 1, wherein, for each of the plurality of leaflets, the second portion of the leaflet, at the first face thereof, faces the frame.

3. The prosthetic valve of claim 1 or 2, wherein, for each of the plurality of leaflets, the second portion of the leaflet, at the first face thereof, is secured at a predetermined height level of the frame, and wherein, for each of the plurality of leaflets, each leaflet body sideline extends past the predetermined height level of the frame in the direction of the inflow end of the frame.

4. The prosthetic valve of claim 3, wherein, for each of the plurality of leaflets, each leaflet body sideline extends past the inflow end of the frame.

5. The prosthetic valve of any one of claims 3 - 4, wherein, for each of the plurality of leaflets, an apex of the second face extends past the predetermined height level of the frame in the direction of the inflow end.

6. The prosthetic valve of claim 5, wherein, for each of the plurality of leaflets, the apex of the second face extends past the inflow end of the frame.

7. The prosthetic valve of claim 6, wherein a difference between a height of the frame in the radially compressed state and a height of the frame in the radially expanded state is at least 2 times the value of a distance between the predetermined height level of the frame and the apex of the second face of each of the plurality of leaflets.

8. The prosthetic valve of any one of claims 6 - 7, wherein, for each of the plurality of leaflets, a distance between the frame and the apex of the second face is at least 10% of a radius of the frame.

9. A prosthetic valve, comprising: a frame having an inflow end and an outflow end, wherein the frame is movable between a radially compressed and a radially expanded state; and a plurality of leaflets secured to the frame, each leaflet having: a leaflet first face and a leaflet second face opposing the leaflet first face, a free edge defining a free edge midpoint, and an opposing cusp edge, the cusp edge defining a cusp edge midpoint and first and second leaflet body sidelines, each leaflet body sideline extending from the cusp edge midpoint to the free edge, wherein in the radially expanded state of the frame the cusp edge midpoint is oriented towards the outflow end of the frame.

10. The prosthetic valve of claim 9, wherein each of the cusp edge midpoint and the free edge is oriented towards the outflow end of the frame.

11. The prosthetic valve of claim 9 or 10, wherein, for each of the plurality of leaflets, the leaflet second face defines a convex surface from the free edge to the cusp edge midpoint, and wherein a portion of the second face, between an apex thereof and the cusp edge midpoint, faces the frame.

12. The prosthetic valve of claim 11, wherein, for each of the plurality of leaflets, the portion of the leaflet second face is generally parallel to the frame.

13. The prosthetic valve of any one of claims 9 - 12, wherein, for each of the plurality of leaflets, the leaflet first face defines a concave surface from the free edge to the cusp edge midpoint.

14. The prosthetic valve of claim 9, wherein, wherein, for each of the plurality of leaflets, the leaflet first face defines a concave surface from the free edge to the cusp edge midpoint and the leaflet second face defines a convex surface from the free edge to the cusp edge midpoint, wherein the concave surface and the convex surface meet at the free edge and the cusp edge midpoint.

15. The prosthetic valve of any one of claims 9 - 14, wherein, for each of the plurality of leaflets, the leaflet second face, at the cusp edge midpoint, is secured at a predetermined height level of the frame, and wherein, for each of the plurality of leaflets, each leaflet body sideline extends past the predetermined height level of the frame in the direction of the inflow end of the frame.

16. A prosthetic valve, comprising: a frame having an inflow end and an outflow end, wherein the frame is movable between a radially compressed and a radially expanded state; and a plurality of leaflets secured to the frame, each leaflet having: a leaflet first face and a leaflet second face opposing the leaflet first face, a free edge defining a free edge midpoint, and an opposing cusp edge, the cusp edge defining a cusp edge midpoint and first and second leaflet body sidelines, each leaflet body sideline extending from the cusp edge midpoint to the free edge, wherein, for each of the plurality of leaflets, the leaflet, at the cusp edge midpoint, is secured at a predetermined height level of the frame, and wherein, for each of the plurality of leaflets, each leaflet body sideline extends past the predetermined height level of the frame in the direction of the inflow end of the frame.

17. The prosthetic valve of claim 16, wherein, for each of the plurality of leaflets, each leaflet body sideline extends at least 1 millimeter past the predetermined height level of the frame in the direction of the inflow end of the frame.

18. The prosthetic valve of claim 17, wherein, for each of the plurality of leaflets, each leaflet body sidelines extends past the inflow end of the frame.

19. The prosthetic valve of claim 18, wherein, for each of the plurality of leaflets, each leaflet body sideline extends at least 1 millimeter past the inflow end of the frame.

20. The prosthetic valve of any one of claims 16 - 19, wherein, for each of the plurality of leaflets, an apex of the second face extends past the predetermined height level of the frame in the direction of the inflow end.

21. The prosthetic valve of claim 20, wherein, for each of the plurality of leaflets, the apex of the second face extends past the inflow end of the frame.

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