Leaflets for prosthetic valves

Abstract

A prosthetic valve, constituted of: 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 plurality of securing points, the plurality of leaflets secured to the frame via the plurality of securing points, wherein, for each of the plurality of leaflets, distances between adjacent securing points when the respective leaflet is not secured to the frame are greater than distances between the adjacent securing points when the respective leaflet is secured to the frame, wherein each of the plurality of leaflets is not flattenable.

Description

LEAFLETS FOR PROSTHETIC VALVESCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 624,705, filed January 24, 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.

[0006] 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

[0007] Accordingly, it is a principal object of the present invention to overcome at least some of the disadvantages of prior art prosthetic valves.

[0008] In some examples this is provided by 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 plurality of securing points, the plurality of leaflets secured to the frame via the plurality of securing points.

[0009] In some examples, for each of the plurality of leaflets, distances between adjacent securing points when the respective leaflet is not secured to the frame are greater than distances between the adjacent securing points when the respective leaflet is secured to the frame.

[0010] In some examples, each of the plurality of leaflets is not flattenable.

[0011] In some examples, wherein at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the adjacent securing points when the respective leaflet is secured to the frame are not uniform.

[0012] 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 secured to the frame, each leaflet having a plurality of securing points, the plurality of leaflets secured to the frame via the plurality of securing points, wherein, for each of the plurality of leaflets, distances between adjacent securing points when the respective leaflet is not secured to the frame aredifferent than distances between the adjacent securing points when the respective leaflet is secured to the frame.

[0013] In some examples, at least some of the differences between distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the adjacent securing points when the respective leaflet is secured to the frame are not uniform.

[0014] In some examples, for each of the plurality of leaflets, the distances between adjacent securing points when the respective leaflet is not secured to the frame are greater than the distances between the adjacent securing points when the respective leaflet is secured to the frame.

[0015] In some examples, each of the plurality of leaflets is not flattenable.

[0016] In some examples, a prosthetic valve can include any of the features recited in Examples 1-84 below.

[0017] Additional features and advantages of the invention will become apparent from the following drawings and description.

[0018] 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 this invention 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".

[0019] 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).

[0020] 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, andadvantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.BRIEF DESCRIPTION OF DRAWINGS

[0021] For a better understanding of the invention and to illustrate how the same may be carried into effect, reference will now be made, purely by way of example, to the accompanying drawings.

[0022] 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 illustrate 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:

[0023] Figs. 1A - 1C illustrate various high-level views and features of a first leaflet for a prosthetic valve, in accordance with some examples.

[0024] Fig. 2A illustrates a high-level view of a first prosthetic valve comprising a plurality of leaflets of Figs. 1 A - 1C, in accordance with some examples.

[0025] Fig. 2B illustrates a high-level view of a second prosthetic valve comprising a plurality of leaflets of Figs. 1A - 1C, in accordance with some examples.

[0026] Fig. 2C illustrates a high-level view of a second leaflet for a prosthetic valve, in accordance with some examples.

[0027] Fig. 2D illustrates a high-level view of a third prosthetic valve comprising a plurality of leaflets, in accordance with some examples.

[0028] Figs. 3A - 3C illustrate parts of an exemplary mold assembly that can be used in a method for fabricating a leaflet valvular structure.

[0029] Fig. 4A illustrates a patch of material prior to placement thereof in a mold assembly.

[0030] Fig. 4B illustrates the 3D-shaped patch removed from a mold assembly.

[0031] Fig. 4C illustrates an optional step in a method for forming a tubular leaflet assembly by rolling the 3D-shaped patch.

[0032] Fig. 4D illustrates an exemplary leaflet assembly that includes an engagement portion.

[0033] Fig. 5 is a perspective view of a first template of an exemplary mold assembly that can be used to form a single leaflet.

[0034] Figs. 6A - 6B illustrate steps of forming leaflets by forging, in accordance with some examples.

[0035] Fig. 7 illustrates an exemplary delivery apparatus carrying a balloon expandable prosthetic valve.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 illustrate the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[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 aparticular 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 - 1C illustrate various high-level perspective views of a leaflet 10afor a leaflet assembly of a prosthetic valve, in accordance with some examples. In some examples, leaflet 10ais 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.

[0042] In some examples, leaflet 10ahas: a leaflet first face 22; a leaflet second face 24 opposing leaflet first face 22; a pair of tabs 26; a free edge 28 extending between tab hinge lines 30 of tabs 26 and defining a free edge midpoint 29; a cusp edge 32 opposing free edge 28 and defining a cusp edge midpoint 33 opposing free edge midpoint 29; a leaflet body 40 defined between the cusp edge 32, tab hinge lines 30 and free edge 28. In some examples, tab hinge lines 30 are each a respective imaginary line shown as a continuation of the cusp edge 32 toward the free edge 28 along each tab 26. Tab hinge lines 30 are each illustrated as a dash line in Figs. 1A - 1C.

[0043] In some examples, leaflet body 40 defines two leaflet body sidelines 42, each extending from the cusp edge midpoint 33 to the free edge 28. In some examples, a first leaflet body sideline 42a extends from the cusp edge midpoint 33 to the free edge 28 and a second leaflet body sideline 42b similarly extends from the cusp edge midpoint 33 to the free edge 28,while opposing first leaflet body sideline 42a. 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 the leaflet assembly across leaflet 10a.

[0044] In some examples, the term "free edge", as used herein, refers to the upper edge of the leaflet extending between both tab hinge lines 30. The leaflet body 40 is defined as the portion of the leaflet 10athat extends between the cusp edge 32, tab hinge lines 30, and free edge 28. That is to say, leaflet body 40 does not include the tabs 26.

[0045] In some examples, leaflet 10ais not flattenable. The term "not flattenable", as used herein, means that it cannot be flattened. Particularly, in some examples, if an attempt is made to straighten out the curve of free edge 28 of leaflet 10a, the curve will not be able to be completely straightened such that leaflet 10abecomes flat. In some examples, if an attempt is made to straighten out the curves of first leaflet body sideline 42a and second leaflet body sideline 42b, the curves will not be able to be completely straightened such that leaflet 10abecomes flat. In one further example, each of first face 22 and second face 24 of leaflet 10ais a non-developable surface. Thus, first face 22 and second face 24 cannot be flattened.

[0046] In some examples, leaflet 10ais curved from first leaflet body sideline 42a to second leaflet body sideline 42b. Particularly, in such an example, any cross-section of leaflet 10aextending from first leaflet body sideline 42a to second leaflet body sideline 42b defines a curve. In one further example, the curve defined by each cross-section of leaflet 10aextending from first leaflet body sideline 42a to second leaflet body sideline 42b exhibits a generally parabolic shape. In another further example, the curve of leaflet 10afrom first leaflet body sideline 42a to second leaflet body sideline 42b forms a predetermined section of an ellipsoid.

[0047] In some examples, leaflet first face 22 is a concave surface. In one further example, leaflet first face 22 is a concave curve whose first end is defined by first leaflet body sideline 42a and whose second end is defined by second leaflet body sideline 42b. 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 another further example, the concavity of leaflet first face 22 is three-dimensional, such that the concave surface is defined by a first concave crosssection extending from first leaflet body sideline 42a to second leaflet body sideline 42b and a second concave cross-section extending from free edge 28 to cusp edge midpoint 33.

[0048] In some examples, leaflet second face 24 is a convex surface. In one further example, leaflet second face 24 is a convex surface whose first end is defined by first leaflet body sideline 42a and whose second end is defined by second leaflet body sideline 42b. The ends of a convex surface, as described herein, are defined such that the convexity of the surfaceextends form the first end to the second end thereof. In another further example, the convexity of leaflet second face 24 is three-dimensional, such that the concave surface defined by a first concave cross-section extending from first leaflet body sideline 42a to second leaflet body sideline 42b and a second concave cross-section extending from free edge 28 to cusp edge midpoint 33.

[0049] In some examples, the distance between first leaflet body sideline 42a and second leaflet body sideline 42b decreases from free edge 28 to cusp edge midpoint 33, i.e. the distance is greater at free edge 28 than at cusp edge midpoint 33. In one further example, this distance is measured via the shortest path along leaflet first face 22 or leaflet second face 24. In another further example, this distance is measured via the shortest direct line from first leaflet body sideline 42a to second leaflet body sideline 42b.

[0050] In some examples, each of first leaflet body sideline 42a and second leaflet body sideline 42b is curved. In one further example, each of first leaflet body sideline 42a and second leaflet body sideline 42b is curved from free edge 28 to cusp edge midpoint 33. In some examples, first leaflet body sideline 42a and second leaflet body sideline 42b meet in cusp edge midpoint 33. In one further example, cusp edge midpoint 33 is defined by the meeting point of first leaflet body sideline 42a and second leaflet body sideline 42b. In some examples, first leaflet body sideline 42a and second leaflet body sideline 42b form a continuous curve, with cusp edge midpoint 33 being a local extremum of this curve. In one further example, the ends of the continuous curve are defined by free edge 28.

[0051] In some examples, leaflet 10afurther comprises a plurality of securing points 50. In some examples, each securing point 50 comprises an aperture. In some examples, coupling of the leaflet 10ato a frame of a prosthetic valve is performed by passing a suture (or other fastener) through the securing points 50 and corresponding struts of the frame, as will be described below.

[0052] Fig. 2A illustrates a high-level perspective view of a prosthetic valve 100a, in accordance with some examples. 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 delivery apparatus 500 (shown for example in Fig. 7) 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 expandedstate. Thus, a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state. The prosthetic valve 100amay 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.

[0053] 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.

[0054] The term "plurality", as used herein, means more than one.

[0055] In some examples, the prosthetic valve 100ahas an inflow end 104 and an outflow end 106. In some examples, the inflow end 104 is the distal end of the prosthetic valve 100a, and the outflow end 106 is the proximal end of the prosthetic valve 100a. 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.

[0056] 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.

[0057] 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.

[0058] 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 100a, for example via the outflow end 106.

[0059] The term "inflow", as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve 100a, for example via the inflow end 104.

[0060] 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.

[0061] The terms "longitudinal" and "axial", as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0062] In some examples, the prosthetic valve 100acomprises an annular frame 102 movable between a radially compressed state and a radially expanded state, and a leaflet assembly 130 mounted within the frame 102. The frame 102 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 102 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 102 can be made of shapememory materials such as, but not limited to, nickel titanium alloy (e.g., Nitinol). When constructed of a shape-memory material, the frame 102 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.

[0063] In the example illustrated in Fig. 2A, the frame 102 is an annular, stent-like structure comprising a plurality of intersecting struts 112. The frame 102 defines a frame inner surface 110 facing inwards, and an opposite frame outer surface 108 facing outwards, 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" 112 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 112may be any elongated member or portion of the frame 102. The frame 102 can have one or more multiple rows of cells defined by intersecting struts 112. The frame 102 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 104 to the outflow end 106 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.

[0064] In some examples, struts 112 comprise angled struts 114, and optionally vertical struts 116. 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 102. It is to be understood that the term "angled strut" encompasses both linear angled struts and curved struts. The exemplary frame 102 of the prosthetic valve 100aillustrated in Fig. 2A comprises a plurality of angled struts 114 and at least two types of vertical struts 116, namely outflow vertical struts 116a formed along the uppermost row of cells (i.e., adjacent outflow end 106), and inflow vertical struts 116b formed along the lowermost row of cells (i.e., adjacent inflow end 104).

[0065] In some examples, two or more struts 112 can intersect at junctions 120, which can be equally or unequally spaced apart from each other. The struts 112 may be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 102 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.

[0066] The leaflet assembly 130 comprises a plurality of leaflets 10a(e.g., three leaflets), positioned at least partially within the frame 102, and configured to regulate flow of blood through the prosthetic valve 100afrom the inflow end 104 to the outflow end 106. While three leaflets 10aarranged to collapse in a tricuspid arrangement, are shown in the exemplary implementation illustrated in Fig. 2A, it will be clear that a prosthetic valve 100acan include any other number of leaflets 10. The leaflets 10aare 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.

[0067] In some examples, when the leaflets 10aare coupled to the frame 102 and to each other, the lower edge of the resulting leaflet assembly 130 has an undulating, curved scalloped shape. In some examples, by forming the leaflets 10awith this scalloped geometry, stresses onthe leaflets 140 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.

[0068] In some examples, the leaflets 10adefine a non-planar coaptation plane (not annotated) when their free edges 28 co-apt with each other to seal blood flow through the prosthetic valve 100a. Leaflets 10acan be secured to one another at their tabs 26 to form commissure assemblies 132 of the leaflet assembly 130, which can be secured, directly or indirectly, to structural elements connected to the frame 102 or embedded therein, such as commissure posts or commissure windows 118. When secured to two other leaflets 10ato form leaflet assembly 130, the cusp edges 32 of the leaflets 10acollectively form the scalloped line of the leaflet assembly 130, shown as a dashed line in Fig. 2A.

[0069] In some examples, at least some (e.g., three) of the outflow vertical struts 116a can be commissure support struts that can define axially extending window frame portions, also termed commissure windows 118. As shown in Fig. 2 A, the commissure window 118 can be configured to receive a corresponding commissure assembly 132. For example, the tabs 26 of a commissure assembly 132 can be passed through the commissure window 118 outward along the radial direction of the frame 102 in order to secure the commissure assembly 132 to the frame 102.

[0070] Various configurations are known in the art by which commissure assemblies may be formed and coupled to a frame 102, 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 such that this outer portion of the commissure assembly cannot pass back through the commissure window.

[0071] Frame 102 is constructed to form an enclosure 111 and leaflets 10aare positioned within enclosure 111. The term "enclosure", as used herein, means an area that is surrounded by frame 102. In some examples, frame 102 is generally cylindrical shaped.

[0072] Fig. 2A illustrates, in partially enlarged view, one exemplary prior art configuration of a commissure assembly 132 coupled to the commissure window 118 using an outer wedge 134. As shown, the commissure assembly 132 can be formed such that two tabs 26a and 26b of adjacent leaflets are wrapped over the outer wedge 134 at the portion extending radially away from the commissure window 118. The total width of both tabs 26 with the outer wedge 134 is greater than the width of the commissure window 118, thereby preventing, or at least restraining, passage of the outer portion of the commissure assembly 132 radially inward.

[0073] While the commissure window 118 is illustrated in Fig. 2A as an opening formed within an outflow vertical strut 116a of the frame 102, it is to be understood that such commissure windows can be similarly formed as part of other components attached to the frame 102, 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 and 62 / 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 132, directly or indirectly, to the frame 102.

[0074] In some examples, leaflets 10aand tabs 26 are formed of a continuous piece of material. In some examples, separate leaflets 10aare provided, and are separately mounted within frame 102 and / or secured to each other.

[0075] In some examples, the prosthetic valve 100acan include an inner skirt 122 mounted on the frame inner surface 110 and / or an outer skirt mounted on the frame outer surface 108 (not shown in Fig. 2A). The inner skirt 122 can be a circumferential inner skirt that spans an entire circumference of the frame inner surface 110. The inner skirt 122 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 100ato the frame 102.

[0076] An outer skirt (not shown) can function as a sealing member by sealing against the tissue of the native valve annulus and helping to reduce paraval vular leakage past the prosthetic valve 100a. 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.

[0077] In some examples, each leaflet 10ais attached to the inner skirt 122 via the securing points 50, the leaflet 10abeing attached to the inner skirt 122 at attachment points 123. In some examples, each leaflet 10ais sutured to the inner skirt 122 via the securing points 50, the leaflet 10abeing sutured to the inner skirt 122 at attachment points 123. In some examples, the securing points 50 extend generally along a scallop line 128 of the leaflet 10a. As used herein, the term “scallop line” can refer to a shape of the cusp edges of the leaflets 10aof a prosthetic heart valve (since it undulates or looks like a scallop). In some examples, the sutures can pass through securing points 50 in an in-and-out pattern to form a plurality of connecting stitches securing the leaflet 10ato the frame 102. In some examples, the inner skirt 122 can be sutured to selected struts of the frame 102.

[0078] In some examples, the securing points 50 can be separated from one another by a distance 55, as shown in Fig. IB. Distance 55 is defined when the leaflet 10ais not secured to the frame 102 (e.g., via inner skirt 122). In some examples, distance 55 is measured from adjacent edges of the securing points 50. In some examples, distance 55 is greater than the distance 125 between adjacent attachment points 123. Thus, when the leaflet 10ais secured to the inner skirt 122, the material of leaflet 10ais compressed. In some examples, the compression of the material of leaflet 10aprevents a space being formed between leaflet 10aand the frame 102, where blood can accumulate.

[0079] In some examples, distance 55 is up to 70% greater than the distance 125 between adjacent attachment points 123. In some examples, distance 55 is up to 40% greater than the distance 125 between adjacent attachment points 123. In some examples, distance 55 is between 30% - 40% greater than the distance 125 between adjacent attachment points 123. In some examples, the distance 55 between adjacent securing points 50 is selected to not be greater than a value which would excessively compress leaflet 10a, thereby causing folds to form within the leaflet 10a.

[0080] In some examples, distance 55 is less than the distance 125 between adjacent attachment points 123. In some examples, where distance 55 is less than the distance 125, the material of leaflet 10ais stretched. In some examples, stretching the material of the leaflet 10acan prevent the curvature of the leaflet 10afrom being too deep which can cause hardening of the material thereof.

[0081] Although the above has been described in relation to examples where the leaflet 10ais attached to an inner skirt 122, this is not meant to be limiting in any way. In some examples, the leaflet 10acan be attached to an outer skirt, as will be described below.

[0082] Fig. 2B illustrates an example of a prosthetic heart valve 200 comprising a radially expandable and compressible annular frame 202 and a plurality of leaflets 10asecured to the frame.

[0083] As described above in relation to frame 102, the frame 202 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 202 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 202 can be made of shapememory materials such as, but not limited to, nickel titanium alloy (e.g., Nitinol). When constructed of a shape-memory material, the frame 202 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.

[0084] As described above in relation to frame 102, the frame 202 comprises a plurality of interconnected struts 206 which form multiple rows of open cells 208 between an outflow end 210 and an inflow end 212 of the frame 202. In some examples, as shown in Fig. 2B, the frame 202 can comprise three rows of cells 208 with a first (e.g., upper in Fig. 2B) row of cells 214, disposed at the outflow end 210, having cells 208 that are elongated in an axial direction, as compared to cells 208 in the remaining rows of cells. For example, the cells 208 of the first row of cells 214 can have a longer axial length than cells 208 in the remaining rows of cells (e.g., cells in the row of cells at the inflow end 212).

[0085] In some examples, the interconnected struts 206 include a plurality of angled struts 218, 234, 236, and 238 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the length of the frame between the outflow end 210 and the inflow end 212 of the frame 202. The angled struts are connected at respective junctions 235. For example, the frame 202 can comprise a first row of angled struts 238 arranged end-to-end and extending circumferentially at the inflow end 212 of the frame; a second row of circumferentially extending, angled struts 236; a third row of circumferentially extending, angled struts 234; and a fourth row of circumferentially extending, angled struts 218 at the outflow end 210 of the frame 12. The fourth row of angled struts 218 can be connected to the third row of angled struts 234 by a plurality of axially extending window strut portions 240 and a plurality of axial (e.g., axially extending) struts 232. In some examples, the axially extending window strut portions 240 define commissure windows (e.g., open windows) 242that are spaced apart from one another around the frame 202, in a circumferential direction, and which are adapted to receive a pair of commissure tabs of a pair of adjacent leaflets 10a.

[0086] Each axial strut 232 and each window strut portion 240 extends from a location defined by the convergence of the lower ends (e.g., ends arranged inward of and farthest away from the outflow end 210) of two angled struts 218 (which can also be referred to as an upper strut junction or upper elongated strut junction) to another location defined by the convergence of the upper ends (e.g., ends arranged closer to the outflow end 210) of two angled struts 234 (which can also be referred to as a lower strut junction or lower elongate strut junction). Each axial strut 232 and each window strut portion 240 forms an axial side of two adjacent cells of the first row of cells 214.

[0087] In some examples, each leaflet 10acan be secured to the struts of the frame 202 (e.g., angled struts 234, 236, and 238) via one or more sutures 124, that extend through securing points 50. For example, the leaflets 10acan be sutured to the angled struts 234, 236, 238 that generally follow the contour of the cusp edge 32 of the leaflets 10. As described above in relation to frame 102, in some examples the distance between adjacent securing points 50 when not secured to the frame is greater than the distance therebetween when secured to the frame. As described above in relation to frame 102, in some examples the distance between adjacent securing points 50 when not secured to the frame is up to 70% greater than the distance therebetween when secured to the frame. As described above in relation to frame 102, in some examples the distance between adjacent securing points 50 when not secured to the frame is up to 40% greater than the distance therebetween when secured to the frame. As described above in relation to frame 102, in some examples the distance between adjacent securing points 50 when not secured to the frame is between 30 - 40% greater than the distance therebetween when secured to the frame.

[0088] In some examples, the distances between securing points 50 that are adjacent to junctions 235 are defined with the above distances since junctions 235 maintain the sutures 124 in place, while the other sutures 124 can move along the respective struts.

[0089] Fig. 2C illustrates a perspective views of a leaflet 10bfor a leaflet assembly of a prosthetic valve, in accordance with some examples. In some examples, leaflet 10bis in all respects similar to leaflet 10adescribed above, with the exception that the distances 56 between adjacent securing points 50 are not uniform. In some examples, as described above in relation to distances 55, distances 56 are measured form adjacent edges of securing points 50. Particularly, in some examples, one or more of the distances 56 may be different than all the rest. In some examples, where the leaflet 10bis secured to a frame 102 (optionally attached toan inner skirt or outer skirt), as described above in relation to Fig. 2A - 2B (and as further described below), the differences between distances 56 and the distances 125 between adjacent attachment points are not uniform. In some examples, this will cause different levels of compression in different areas of the leaflet 10b. Such a difference in the levels of compression throughout the leaflet can cause a more profound change in shape, thereby further improving the prevention of the formation of a space between the leaflet of the frame (as described above).

[0090] In some examples, the distances 56 change gradually along the length of cusp edge 32. In some examples, the distances 56 increase the closer the securing points 50 are to the free edge 28. In some examples, the distances 56 increase the closer the securing points 50 are to the cusp edge midpoint 33.

[0091] In some examples, some of the distances 56 are greater than the distances 125 of the attachment points and some of the distances 56 are equal to, or less than, the distances 125 of the attachment points. In some examples, where some portions of the material of the leaflet are compressed, and other portions of the material of the leaflet are not compressed, or that are stretched, this reduces the chance of lateral folds forming in the leaflet.

[0092] Fig. 2D illustrates a high-level perspective view of a prosthetic valve 100b. In some examples, prosthetic valve 100bis in all respects similar to prosthetic valve 100adescribed above, with the exception that an outer skirt 250 is provided instead of an inner skirt. Outer skirt 250 is secured to a frame outer surface 108. A plurality of leaflets 10care secured to the frame 102. The distances between securing points 50 in leaflet 10ccan be uniform, as shown in relation to leaflet 10a, or non-uniform, as shown in leaflet 10b.

[0093] In some examples, as shown, the leaflet 10cis attached to the outer skirt 250 via securing points 50 and attachment points 252 on the outer skirt 250. In some examples, the leaflet 10cis attached to the outer skirt 250 with sutures 124. In some examples, as shown, the distances 255 between adjacent attachment points 252 are not uniform. In some examples, the distances 255 are measured between adjacent edges of attachment points 252. As described above, in some examples, the differences between distances 255 of the outer skirt 250 and the distances 55, or 56, of the leaflet 10cchange along the scallop edge of the leaflet 10c.

[0094] Figs. 3A-3C illustrate parts of an exemplary mold assembly 310 that can be used in a method for fabricating a leaflet assembly 130 defining leaflets 10 thereof (e.g., leaflets 10a, 10band 10c). The mold assembly 310 can include a first template 312 and a second template 332. The first 312 and second 332 templates can have complementary surfaces, configured to sandwich a patch 300 of material, such as tissue material, therebetween, during formation and shaping of the patch 300 to assume a three-dimensional configuration, as will be described ingreater detail below. In some examples, the first 312 and second 332 templates can be provided as separate components that can be coupled to each other, such as when a patch 300 is placed therebetween, for example by virtue of appropriate fasteners 352 configured to couple both templates to each other. In some examples, the first 312 and second 332 templates can be connected to each other, such as in a pivotable manner along a hinge (not shown). Fig. 3 A illustrates a perspective view of a mold assembly 310 with first template 312 positioned above, and spaced apart from, the second template 332. Fig. 3B illustrates a perspective view the first template 312 inverted relative to its orientation in Fig. 3 , so as to expose the surfaces configured to contact a patch 300 during formation of a leaflet assembly 130. Fig. 3C illustrates a front perspective view of the second template 332 of Fig. 3C.

[0095] In some examples, mold assembly 310ashown in Figs. 3A-3C is an exemplary implementation of mold assembly 310, and thus includes features described for mold assembly 310 throughout the current disclosure, except that while mold assembly 310 can be used to form either the leaflet assembly 130 as a unitary one-piece structure, or to form separate leaflets 10 that can be joined to form a leaflet assembly 130, mold assembly 310ais configured to fabricate a one-piece leaflet assembly 130.

[0096] The first template 312 of mold assembly 310acan include a planar segment 314 and a plurality of raised leaflet forming portions 316, such as the three raised leaflet forming portions 316a, 316b and 316c in the illustrated example. The second template 332 of mold assembly 310acan include a planar segment 334 and a plurality of recessed leaflet forming portions 336, such as the three recessed leaflet forming portions 336a, 336b and 336c in the illustrated example. While the mold assembly 310ais described herein and illustrated in Figs. 3A-3C to include three raised leaflet forming portions 316 and three recessed leaflet forming portions 336, it is to be understood that this is shown by way of illustration and not limitation, and that a mold assembly 310acan include two or more than three raised 316 and recessed 336 leaflet forming portions, matching the number of leaflets 10 in the desired resulting leaflet assembly 130 to be mounted in a frame 102 or 202. Thus, any reference to three raised leaflet forming portions 316 or three recessed leaflet forming portions 336 of mold assembly 310acan be replaced by any other number, such as two or more than three, matching the number of desired leaflets 10 of the leaflet assembly 130.

[0097] The raised leaflet forming portions 316 can be laterally spaced from each other, so as to define intermediate regions 326 therebetween. The recessed leaflet forming portions 336 can be similarly spaced from each other laterally, so as to define intermediate regions 346 therebetween. Each raised leaflet forming portion 316 can include one or more surfaces shapedto instill a 3D shape of a leaflet 10, wherein each recessed leaflet forming portion 336 can have a shape that is complementary to the shape of the corresponding raised leaflet forming portions 316, also including similarly shaped one or more surfaces generally parallel to the one or more surfaces of the raised leaflet forming portion 316 when the templates 312 and 332 are coupled to each other, for example.

[0098] In some examples, each raised leaflet forming portion 316 comprises a curvilinear surface 318 that can be generally convex, a first outflow surface 320 and a second outflow surface 322 that intersect with each other and with the curvilinear surface 318, wherein the curvilinear surface 318 extends from an end of a cusp line 324 that is closer to the planar segment 314, and the first 320 and second 322 outflow surfaces are closer to an end of the first template 312 that is opposite to the planar segment 314, optionally extending from intermediate regions 326 on both sides of the corresponding raised leaflet forming portion 316 towards each other. In some examples, the first outflow surface 320 and the second outflow surface 322 can be planar surfaces. In some examples, the first outflow surface 320 and the second outflow surface 322 can be curved surfaces, optionally having different surface curvatures than the curvilinear surface 318.

[0099] In some examples, each recessed leaflet forming portion 336 comprises a curvilinear surface 338 that can be generally concave, a first outflow surface 340 and a second outflow surface 342 that intersect with each other and with the curvilinear surface 338, wherein the curvilinear surface 338 extends from an end of a cusp line 344 that is closer to the planar segment 334, and the first 340 and second 342 outflow surfaces are closer to an end of the second template 332 that is opposite to the planar segment 334, optionally extending from intermediate regions 346 on both sides of the corresponding recessed leaflet forming portion 336 towards each other. In some examples, the first outflow surface 340 and the second outflow surface 342 can be planar surfaces. In some examples, the first outflow surface 340 and the second outflow surface 342 can be curved surfaces, optionally having different surface curvatures than the curvilinear surface 338.

[0100] Figs. 4A-4D illustrate some stages in a method of forming a leaflet assembly 130. Fig. 4A illustrates a patch 300 of material, which can be a tissue patch having a generally rectangular patch extending between side edges 302. This patch 300 can be inserted into the mold assembly 310 between the first template 312 and the second template 332, after which both templates 312, 332 can be coupled to each other sandwiching the patch 300 therebetween, forcing it to assume the shape defined by the various surfaces of the templates 312, 332. It is to be understood that the patch 300 can be first placed over the first template 312 and the secondtemplated 332 can be then closed over the patch 300 and the first template 312, or the patch 300 can be first placed over the second template 332 and the first template 312 can be then closed over the patch 300 and the second template 332.

[0101] Coupling of the first 312 and second 332 templates to each other can be accomplished by a variety of fastening means known in the art. For example, the second template 332 can include fasteners 352 in the form of pins, as shown in Figs. 3A-3C, configured to extend into matching holes or apertures (not annotated separately) in the first template 312, though it is to be understood that the first template 312 can include similar pin-like fasteners 352 insertable into matching holes or apertures formed in the second template 332. Pins can be replaced, in some examples, by bolts that can be inserted into the holes or apertures and tightened with corresponding nuts (not shown). It is to be understood that other suitable means for coupling the first 312 and second 332 templates to each other are contemplated, optionally allowing to apply a desired pressure to a tissue patch 300 disposed therebetween.

[0102] When the first 312 and second 332 templates are coupled to each other, the planar segment 314, raised leaflet forming portions 316, and intermediate regions 326 of the first template 312 are aligned with the planar segment 334, recessed leaflet forming portions 336, and intermediate regions 346 of the second template 332.

[0103] In some examples, when the patch 300 comprises a tissue (e.g., pericardium), a cross-linking solution may be applied to the patch 300 in order to facilitate cross-linking of the tissue. In some examples, the cross-linking solution comprises glutaraldehyde. In some examples, the cross-linking solution may be injected into the patch 300. In some examples, the patch 300 may be soaked, immersed in, or penetrated with the cross-linking solution. In some examples, glutaraldehyde may be injected into the patch 300, and examples, the patch 300 may be soaked, immersed in, or penetrated with glutaraldehyde.

[0104] In some examples, a mold assembly 310 with the patch 300 disposed therein, may be immersed into a cross-linking solution, which may comprise glutaraldehyde. In some examples, one template of the mold assembly 310, such as the second template 332, may be removed from the mold assembly 310 when the patch 300 is partially cross-linked, and the patch 300, which can have a three-dimensional form of the desired leaflets 10, meaning that the formed leaflets 10 are not flattenable, may be removed from the mold assembly 310 once it is fully cross-linked. In some examples, one template of the mold assembly 310, such as the second template 332, may be removed from the mold assembly 310 while the mold assembly 310 remains immersed in the cross-linking solution or glutaraldehyde. In some examples, a spacer or a spacing layer (not shown) may be inserted between the first 312 and second 332templates before glutaraldehyde is applied to the patch 300. In some examples, at least one of the first 312 and / or second 332 templates can include perforations (not shown) through which cross-linking solution can flow towards portions of the patch 300 placed between the templates 312, 332.

[0105] Fig. 4B illustrates the patch 300 removed from the mold assembly 310. Crosslinking the tissue patch 300 can result in the tissue maintaining its shape after being removed or separated from the mold assembly 310. As shown, when formed by molding assembly 310a, the patch 300 is a one-piece patch that includes all three sections of the leaflet assembly 130 as continuous segments thereof. Fig. 4C illustrates an optional subsequent step of forming a tubular leaflet assembly 130 by rolling the 3D-shaped patch 300. For example, the side edges 302 can be brought together in a mating or otherwise abutting relationship. Once mated, both side edges 302 can be coupled to each other, such as by sewing, adhering, or otherwise attaching the side edges 302, thus resulting in a substantially cylindrical leaflet assembly 130 as shown in Fig. 3D.

[0106] Each leaflet 10 of the leaflet assembly 130, as shown in Fig. 3D, has a free edge 28 and a cusp line 276 that can have, in some example, a curved shape, opposite to the free edge 28. The cusp line 276 of each leaflet 10 can form a single scallop that can be, for example, parabolic in shape. Commissure attachment regions 280 of the leaflet assembly 130 can be defined between adjacent leaflets 10, as regions of the leaflet assembly 130 that extend to a certain axial length from the level of the free edges 28. A leaf-shaped leaflet belly 274 of each leaflet 10 is defined between the cusp line 276 and the free edge 28, excluding the commissure attachment regions 280.

[0107] When the leaflet assembly 130 is coupled to the frame 102, or 202, as described above, a line of attachment, also referred to as a scalloped line, can extend along the cusp line 276 of all leaflets 10, together forming a scalloped shaped attachment pattern that can be stitched or otherwise coupled to the frame, directly or indirectly. As described above, securing points 50 are further provided (not shown in Fig. 4D). The scalloped line of attachment, following at least a portion of the cusp lines 276, such as parallel to and somewhat distal to the cusp lines, optionally without extending into the commissure attachment regions 280, can have an undulating, curved scalloped shape. By forming the leaflets of the leaflet assembly 130 with this scalloped geometry (such as along the cusp lines 276), stresses on the leaflets 10 are reduced which, in turn, improves durability of the valve 100 or 200. The leaflet belly 274 of each leaflet 10 is the part of the leaflet 10 remaining unattached to the frame or othercomponents of the valve after assembly, configured to open and close (or coapt) during operation of the prosthetic valve 100 or 200, such as during systole and diastole.

[0108] The shape of the leaflet bellies 274 in their free state is dictated by the shapes of the raised 316 and recessed 336 leaflet forming portions of the mold assembly 310. For example, a leaflet belly 274 of leaflet 10 formed by a mold assembly 310 can have a concave region 282 matching the shape of the curvilinear surfaces 318 and 338 of the mold assembly 310, and outflow regions 284 and 286 extending between the free edge 28 and the curvilinear region 182, matching the shapes of first outflow surfaces 320, 340 and second outflow surfaces 322, 342 of the mold assembly 310, when the outflow surfaces 320, 340 and 322, 342 are planar in shape. When the surfaces 320, 340 and 322, 342 of the mold assembly 310 are curved, matching curvatures can be formed along the regions 284 and 286 of the leaflet 10. The outflow regions 284 and 286 can be either planar or curved regions.

[0109] While leaflet bellies 274 are designed to be not flattenable, as described above, optionally having a three-dimensional shape combined of three intersecting regions 282, 284 and 286 having non-identical surface curvatures, it is to be understood that any other three- dimensional shape of a leaflet belly 274 is contemplated, including cup-shaped or otherwise shaped bellies 274 formed between mating three-dimensionally shaped raised 316 and recessed 336 leaflet forming portions of the mold assembly 310, which can similarly result in the leaflet belly 274 being not flattenable.

[0110] In some examples, the curvatures of mold 310, including the curvature of curvilinear surface 338, is designed such that the curvature of leaflet 10 is no greater than a predetermined value. In some examples, the predetermined value is such that an area defined between the cusp lines 276 of the leaflet 10, which doesn't follow the curvature of the leaflet belly 274, is no more than 2% less than the area defined between the cusp lines 276 which does follow the curvature of the leaflet belly. In some examples, this can reduce the probability of the curvature flattening itself out over time.

[0111] Fig. 4D illustrates a leaflet assembly 130a, which can be similar to any example of a leaflet assembly 130 disclosed herein, except that the leaflet assembly 130afurther comprises an engagement portion 290 extending between a distal end 292 thereof and the cusp lines 276, wherein the distal end 292 of the engagement portion 290 can be circular in the cylindrical configuration of the leaflet assembly 130aas shown in Fig. 4D, or substantially linear in a flattened configuration of the leaflet assembly 130aas shown in Fig. 4B for example. In some examples, the engagement portion 290 can be cylindrically disposed along an inner surface of the frame 102 or 202, and coupled thereto, such as by sutures or other couplers, that extendboth through the scalloped line following at least a portion of the cusp lines 276 (through securing points 50), and the distal end 292 of the engagement portion 290.

[0112] It is to be understood that a reference to a distal end of an engagement portion as a linear distal end means that the distal end 292 is not curved or otherwise angled in the axial direction, even though the distal end 292 is circumferentially disposed along the circumference of the frame 102 or 202 when the leaflet assembly 130 is mounted therein. Stated otherwise, the distal end 292 of the engagement portion 290 is at a uniform axial distance from the free edge(s) 28, which can define a uniform height Hv as shown in Fig. 4D. Another definition of a linear distal end 292 can refer to the distal end 292 being at a uniform axial distance from the inflow end 104. Since the cusp lines have a curved shape in the axial direction, this also means that the axial distance between the distal end 292 of the engagement portion 290 and the cusp line 276 varies along the circumference of each leaflet 10, increasing in size from the inflow peak of the corresponding cusp line 276 towards the commissure attachment regions 280.

[0113] The engagement portion 290 can be defined between the planar segments 314 and 334 of the first 312 and second 332 templates, respectively, during formation of the leaflet assembly 130. Thus, in contrast to the leaflet bellies 274 which are not flattenable, the engagement portion 290 are flattenable, meaning that when the leaflet assembly 130 is unattached to the frame and spread over a flat surface, the engagement portions can be flattened. Having flattenable engagement portions 290 can assist in attachment thereof to the frame 102 or 202, wherein a flattenable engagement portion 290 can be rolled into a cylindrical or semi-cylindrical shape that can conveniently cover the inner surface of the frame 102 or 202, while the leaflet bellies 274, which are movable portions that remain unattached to the frame, can be formed as portions which are not-flattenable to improve performance of the leaflet assembly 130 as described above.

[0114] The commissure attachment regions 280 can be defined between the intermediate regions 326 and 346 of the first 312 and second 332 templates, respectively, during formation of the leaflet assembly 130. The cusp lines 276 of the leaflet assembly 130 can be formed between the cusp lines 324 and 344 of the first 312 and second 332 templates, respectively, during formation of the leaflet assembly 130.

[0115] Fig. 5 illustrates a perspective view of a first template 312bof an exemplary mold assembly 310b. The first template 312bcan be similar to any example of the first template 312, including template 312a, describe herein, except that the first template 312bincludes a single raised leaflet forming portion 316 instead of a plurality of raised leaflet forming portions 316 illustrated in Figs. 3A-3C. The raised leaflet forming portion 316 of first template 312bcanhave a curvilinear surface 318 and first 320 and second 322 outflow surfaces, or have any other three-dimensional shape, as described with respect to any example of a raised leaflet forming portion 316 described herein. The first template 312bcan further include a planar segment 314 distal to the cusp line 324 and intermediate regions 326 at opposite sides of the raised leaflet forming portion 316. While not shown for the sake of brevity, it is to be understood that the mold assembly 310bfurther includes a complementary second template 332bthat includes a single recessed leaflet forming portion 336, shaped to mate with the first template 312b.

[0116] The mold assembly 10bcan be utilized to form individual leaflets 10, in the same manner described above, mutatis mutandis. In some examples, an individual leaflet 10 formed by a mold assembly 210bcan further include laterally extending tabs (not shown) at the commissure attachment regions 280, defined between the free edge 28 and the cusp line 276 of the leaflet 10.

[0117] Figs. 6A - 6B illustrate another example for forming leaflets 10 by forging. Fig. 6A illustrates a two-part leaflet shape forming apparatus 400 that includes a base portion 410 and a die portion 420. The base portion 410 can include a mandrel that defines one or more concave surfaces 412, such as the three concave surfaces 412 of the illustrated example. The concavity of each surface 412 is designed to match the desired concavity of leaflet first face 22. The die portion 420 defines one or more convex surfaces 422, matching in number to the number of concave surfaces 412, and having a shape complementary to that of the concave surfaces 412.

[0118] As shown in Fig. 6A, leaflets 10, which can be provided in a flattened configuration, are placed over the concave surfaces 412, and are then pressed between the concave surfaces 412 of the base portion 410 and the convex surface 422 of the die portion 420, to assume the final non-flattenable curved shape described above. As described above in relation to mold 310, in some examples, the curvatures of the concave surfaces 412 and convex surfaces 422 are designed such that the curvature of leaflet 10 is no greater than a predetermined value. In some examples, the predetermined value is such that an area defined between the cusp lines 276 of the leaflet 10, which doesn’t follow the curvature of the leaflet first face 22, is no more than 2% less than the area defined between the cusp lines 276 which does follow the curvature of the leaflet first face 22. In some examples, this can reduce the probability of the curvature flattening itself out over time.

[0119] Fig. 7 illustrates a delivery apparatus 500, according to one configuration, adapted to deliver a balloon expandable prosthetic valve 560 described herein (e.g., prosthetic valve 100 and 200). It should be understood that the delivery apparatus 500 can be used to implant prosthetic devices other than prosthetic valves, such as stents or grafts.

[0120] The delivery apparatus 500 includes a handle 504 and a balloon catheter 552 having an inflatable balloon 550 mounted on its distal end. The balloon expandable prosthetic valve 560 can be carried in a crimped state over the balloon catheter 552. Optionally, an outer delivery shaft 524 can concentrically extend over the balloon catheter 552, and a push shaft 520 disposed over the balloon catheter 552, optionally between the balloon catheter 552 and the outer delivery shaft 524.

[0121] The outer delivery shaft 524, the push shaft 520, and the balloon catheter 552, can be configured to be axially movable relative to each other. For example, a proximally oriented movement of the outer delivery shaft 524 relative to the balloon catheter 552, or a distally oriented movement of the balloon catheter 552 relative to the outer delivery shaft 524, can expose the prosthetic valve 560 from the outer delivery shaft 524. The delivery apparatus 500 can further include a nosecone 540 connected to the distal end of a nosecone shaft (hidden from view in Fig. 7) extending through a lumen of the balloon catheter 552.

[0122] Outer delivery shaft 524, push shaft 520, balloon 550, balloon catheter 552, and nosecone 540 along with the nosecone shaft 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, outer delivery shaft 524 and push shaft 620 have longitudinal sections formed from different materials in order to vary the flexibility of the shafts along their lengths. In some examples, the nosecone shaft has an inner liner or layer formed of Teflon® to minimize sliding friction with a guide wire (not shown).

[0123] The proximal ends of the balloon catheter 552, the outer delivery shaft 524, the push shaft 520, and optionally the nosecone shaft, can be coupled to the handle 504. During delivery of the prosthetic valve 560, the handle 504 can be maneuvered by an operator (e.g., a clinician or a surgeon) to axially advance or retract components of the delivery apparatus 500, such as the nosecone shaft, the balloon catheter 552, the outer delivery shaft 524, and / or the push shaft 520, through the patient's vasculature, as well as to inflate the balloon 550 mounted on the balloon catheter 552, so as to expand the prosthetic valve 560, and to deflate the balloon 550 and retract the delivery apparatus 500 once the prosthetic valve 560 is mounted in the implantation site.

[0124] The handle 504 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 500. In the illustrated example, the handle 504 includes an adjustment member, such as the illustrated rotatable knob 560a, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 504 through the outer delivery shaft 624 and has a distal end portionaffixed to the outer delivery shaft 624 at or near the distal end of the outer delivery shaft 624. Rotating the knob 560a can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 600. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein. The handle 504 can further include an adjustment mechanism including an adjustment member, such as the illustrated rotatable knob 506b. The adjustment mechanism can be configured to adjust the axial position of the push shaft 520 relative to the balloon catheter.

[0125] The prosthetic valve 560 can be carried by the delivery apparatus 500 during delivery in a crimped state, and expanded by balloon inflation to secure it in a native heart valve annulus. In one exemplary implantation procedure, the prosthetic valve 560 is initially crimped over the balloon catheter 552, proximal to the inflatable balloon 550. Because prosthetic valve 560 is crimped at a location different from the location of balloon 550, prosthetic valve 560 can be crimped to a lower profile than would be possible if it was crimped on top of balloon 550. This lower profile permits the clinician to more easily navigate the delivery apparatus 500 (including crimped prosthetic valve 560) through a patient’s vasculature to the treatment location. The lower profile of the crimped prosthetic valve is particularly helpful when navigating through portions of the patient's vasculature which are particularly narrow, such as the iliac artery.

[0126] The balloon 550 can be secured to balloon catheter 552 at its balloon proximal end, and to either the balloon catheter 552 or the nosecone 540 at its distal end. The distal end portion of the push shaft 520 is positioned proximal to the outflow end (e.g., outflow end 104,) of the prosthetic valve 560.

[0127] When reaching the site of implantation, and prior to balloon inflation, the push shaft 520 is advanced distally, allowing its distal end portion to contact and push against the outflow end of prosthetic valve 560, pushing the valve 560 distally therewith. The distal end of push shaft 520 is dimensioned to engage with the outflow end of the prosthetic valve 560 in a crimped configuration of the valve. In some implementations, the distal end portion of the push shaft 520 can be flared radially outward, to terminate at a wider-diameter that can contact the prosthetic valve 560 in its crimped state. Push shaft 520 can then be advanced distally, pushing the prosthetic valve 560 therewith, until the crimped prosthetic valve 560 is disposed around the balloon 550, at which point the balloon 550 can be inflated to radially expand the prosthetic valve 560. Once the prosthetic valve 560 is expanded to its functional diameter within a nativeannulus, the balloon 550 can be deflated, and the delivery apparatus 500 can be retrieved from the patient’s body.

[0128] In particular implementations, the delivery apparatus 500 with the prosthetic valve 560 assembled thereon, can be packaged in a sterile package that can be supplied to end users for storage and eventual use. In particular implementations, the leaflets of the prosthetic valve (typically made from bovine pericardium tissue or other natural or synthetic tissues) are treated during the manufacturing process so that they are completely or substantially dehydrated and can be stored in a partially or fully crimped state without a hydrating fluid. In this manner, the package containing the prosthetic valve 560 and the delivery apparatus 500 can be free of any liquid. Methods for treating tissue leaflets for dry storage are disclosed in U.S. Pat. Nos. 8,007,992 and 8,357,387, both of which documents are incorporated herein by reference.Some Examples of the Disclosed Technology

[0129] Some examples of above-described technology are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application.

[0130] 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 plurality of securing points, the plurality of leaflets secured to the frame via the plurality of securing points, wherein, for each of the plurality of leaflets, distances between adjacent securing points when the respective leaflet is not secured to the frame are greater than distances between the adjacent securing points when the respective leaflet is secured to the frame, wherein each of the plurality of leaflets is not flattenable.

[0131] Example 2. The prosthetic valve of any example herein, particularly example 1, wherein each of the plurality of leaflets comprises a first face and a second face opposing the first face, and wherein, for each of the plurality of leaflets, the leaflet first face and the leaflet second face are non-developable surfaces.

[0132] Example 3. The prosthetic valve of any example herein, particularly example 2, wherein each of the plurality of leaflets comprises 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.

[0133] Example 4. The prosthetic valve of any example herein, particularly example 3, 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.

[0134] Example 5. The prosthetic valve of any example herein, particularly example 4, 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.

[0135] Example 6. The prosthetic valve of any example herein, particularly any one of examples 2 - 5, wherein each of the plurality of leaflets is curved from the free edge to the cusp edge midpoint.

[0136] Example 7. The prosthetic valve of any example herein, particularly any one of examples 1 - 6, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame are such that the respective leaflet is compressed when secured to the frame.

[0137] Example 8. The prosthetic valve of any example herein, particularly example 7, wherein the distances between adjacent securing points when the respective when the respective leaflet is not secured to the frame are such that folds are not formed in the respective leaflet.

[0138] Example 9. The prosthetic valve of any example herein, particularly any one of examples 1 - 8, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the adjacent securing points when the respective leaflet is secured to the frame by up to 70%.

[0139] Example 10. The prosthetic valve of any example herein, particularly example 9, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the adjacent securing points when the respective leaflet is secured to the frame by up to 40%.

[0140] Example 11. The prosthetic valve of example 10, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the adjacent securing points when the respective leaflet is secured to the frame by 30 - 40%.

[0141] Example 12. The prosthetic valve of any example herein, particularly any one of examples 1 - 11, wherein at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distancesbetween the adjacent securing points when the respective leaflet is secured to the frame are uniform.

[0142] Example 13. The prosthetic valve of any example herein, particularly example 12, wherein all of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the adjacent securing points when the respective leaflet is secured to the frame are uniform.

[0143] Example 14. The prosthetic valve of any example herein, particularly any one of examples 1 - 11 , wherein at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the adjacent securing points when the respective leaflet is secured to the frame are not uniform.

[0144] Example 15. The prosthetic valve of any example herein, particularly example 1, wherein each of the plurality of leaflets comprises 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 at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the adjacent securing points when the respective leaflet is secured to the frame are not uniform, and wherein the differences increase the closer the securing points are to the free edge and decrease the closer the securing points are to the cusp edge midpoint.

[0145] Example 16. The prosthetic valve of any example herein, particularly example 1, wherein each of the plurality of leaflets comprises 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 at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the adjacent securing points when the respective leaflet is secured to the frame are not uniform, and wherein the differences decrease the closer the securing points are to the free edge and increase the closer the securing points are to the cusp edge midpoint.

[0146] Example 17. The prosthetic valve of any example herein, particularly example 1, further comprising an inner skirt secured to an inner surface of the frame, wherein each of the plurality of leaflets is attached to the inner skirt via the plurality of securing points.

[0147] Example 18. The prosthetic valve of any example herein, particularly example 17, wherein each of the plurality of leaflets is sutured to the inner skirt via the plurality of securing points.

[0148] Example 19. The prosthetic valve of any example herein, particularly example 17 or 18, wherein each of the plurality of leaflets is attached to the inner skirt at a plurality of attachment points on the inner skirt, each of the plurality of attachment points corresponding to a respective one of the plurality of securing points of the respective leaflet, wherein, for each of the plurality of leaflets, distances between adjacent securing points when the respective leaflet is not secured to the frame are greater than distances between the corresponding attachment points on the inner skirt.

[0149] Example 20. The prosthetic valve of any example herein, particularly example 19, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame, and the distances between the corresponding attachment points on the inner skirt, are such that the respective leaflet is compressed when secured to the frame.

[0150] Example 21. The prosthetic valve of any example herein, particularly example 20, wherein the distances between adjacent securing points when the respective when the respective leaflet is not secured to the frame, and the distances between the corresponding attachment points on the inner skirt, are such that folds are not formed in the respective leaflet.

[0151] Example 22. The prosthetic valve of any example herein, particularly any one of examples 19 - 22, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the corresponding attachment points on the inner skirt by up to 70%.

[0152] Example 23. The prosthetic valve of any example herein, particularly example 22, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the corresponding attachment points on the inner skirt by up to 40%.

[0153] Example 24. The prosthetic valve of any example herein, particularly example 23, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the corresponding attachment points on the inner skirt by 30 - 40%.

[0154] Example 25. The prosthetic valve of any example herein, particularly any one of examples 19 - 24, wherein at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the corresponding attachment points on the inner skirt are uniform.

[0155] Example 26. The prosthetic valve of any example herein, particularly example 25, wherein all of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the corresponding attachment points on the inner skirt are uniform.

[0156] Example 27. The prosthetic valve of any example herein, particularly any one of examples 19 - 24, wherein at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the corresponding attachment points on the inner skirt are not uniform.

[0157] Example 28. The prosthetic valve of any example herein, particularly example 27, wherein each of the plurality of leaflets comprises 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, and wherein the differences increase the closer the securing points are to the free edge and decrease the closer the securing points are to the cusp edge midpoint.

[0158] Example 29. The prosthetic valve of any example herein, particularly example 27, wherein each of the plurality of leaflets comprises 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, and wherein the differences decrease the closer the securing points are to the free edge and increase the closer the securing points are to the cusp edge midpoint.

[0159] Example 30. The prosthetic valve of any example herein, particularly example 1, further comprising an outer skirt secured to an outer surface of the frame, wherein each of the plurality of leaflets is attached to the outer skirt via the plurality of securing points.

[0160] Example 31. The prosthetic valve of any example herein, particularly example 30, wherein each of the plurality of leaflets is sutured to the outer skirt via the plurality of securing points.

[0161] Example 32. The prosthetic valve of any example herein, particularly example 30 or 31, wherein each of the plurality of leaflets is attached to the outer skirt at a plurality of attachment points on the outer skirt, each of the plurality of attachment points corresponding to a respective one of the plurality of securing points of the respective leaflet, wherein, for each of the plurality of leaflets, distances between adjacent securing points when the respective leaflet is not secured to the frame are greater than distances between the corresponding attachment points on the outer skirt.

[0162] Example 33. The prosthetic valve of any example herein, particularly example 32, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame, and the distances between the corresponding attachment points on the outer skirt, are such that the respective leaflet is compressed when secured to the frame.

[0163] Example 34. The prosthetic valve of any example herein, particularly example 33, wherein the distances between adjacent securing points when the respective when the respective leaflet is not secured to the frame, and the distances between the corresponding attachment points on the outer skirt, are such that folds are not formed in the respective leaflet.

[0164] Example 35. The prosthetic valve of any example herein, particularly any one of examples 32 - 34, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the corresponding attachment points on the outer skirt by up to 70%.

[0165] Example 36. The prosthetic valve of any example herein, particularly example 35, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the corresponding attachment points on the outer skirt by up to 40%.

[0166] Example 37. The prosthetic valve of any example herein, particularly example 36, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the corresponding attachment points on the outer skirt by 30 - 40%.

[0167] Example 38. The prosthetic valve of any example herein, particularly any one of examples 32 - 37, wherein at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the corresponding attachment points on the outer skirt are uniform.

[0168] Example 39. The prosthetic valve of any example herein, particularly example 38, wherein all of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the corresponding attachment points on the outer skirt are uniform.

[0169] Example 40. The prosthetic valve of any example herein, particularly any one of examples 32 - 37, wherein at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the corresponding attachment points on the outer skirt are not uniform.

[0170] Example 41. The prosthetic valve of any example herein, particularly example 40, wherein each of the plurality of leaflets comprises 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, and wherein the differences increase the closer the securing points are to the free edge and decrease the closer the securing points are to the cusp edge midpoint.

[0171] Example 42. The prosthetic valve of any example herein, particularly example 40, wherein each of the plurality of leaflets comprises 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, and wherein the differences decrease the closer the securing points are to the free edge and increase the closer the securing points are to the cusp edge midpoint.

[0172] Example 43. The prosthetic valve of any example herein, particularly example 1, wherein each of the plurality of leaflets is attached to the frame via the plurality of securing points.

[0173] Example 44. The prosthetic valve of any example herein, particularly example 43, wherein each of the plurality of leaflets is sutured to the frame via the plurality of securing points.

[0174] Example 45. The prosthetic valve of any example herein, particularly any one of examples 1 - 44, wherein, for each of the plurality of leaflets, each of the plurality of securing points comprises an aperture.

[0175] Example 46. 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 plurality of securing points, the plurality of leaflets secured to the frame via the plurality of securing points, wherein, for each of the plurality of leaflets, distances between adjacent securing points when the respective leaflet is not secured to the frame are different than distances between the adjacent securing points when the respective leaflet is secured to the frame, wherein at least some of the differences between distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the adjacent securing points when the respective leaflet is secured to the frame are not uniform.

[0176] Example 47. The prosthetic valve of any example herein, particularly example 46, wherein each of the plurality of leaflets comprises 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 at least some of the differences between the distances between adjacentsecuring points when the respective leaflet is not secured to the frame and the distances between the adjacent securing points when the respective leaflet is secured to the frame are not uniform, and wherein the differences increase the closer the securing points are to the free edge and decrease the closer the securing points are to the cusp edge midpoint.

[0177] Example 48. The prosthetic valve of any example herein, particularly example 46, wherein each of the plurality of leaflets comprises 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 at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the adjacent securing points when the respective leaflet is secured to the frame are not uniform, and wherein the differences decrease the closer the securing points are to the free edge and increase the closer the securing points are to the cusp edge midpoint.

[0178] Example 49. The prosthetic valve of any example herein, particularly any one of examples 46 - 48, wherein, for each of the plurality of leaflets, the distances between adjacent securing points when the respective leaflet is not secured to the frame are greater than the distances between the adjacent securing points when the respective leaflet is secured to the frame.

[0179] Example 50. The prosthetic valve of any example herein, particularly example 49, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the adjacent securing points when the respective leaflet is secured to the frame by up to 70%.

[0180] Example 51. The prosthetic valve of any example herein, particularly example 50, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the adjacent securing points when the respective leaflet is secured to the frame by up to 40%.

[0181] Example 52. The prosthetic valve of any example herein, particularly example 51, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the adjacent securing points when the respective leaflet is secured to the frame by 30 - 40%.

[0182] Example 53. The prosthetic valve of any example herein, particularly any one of examples 46 - 48, wherein, for each of the plurality of leaflets, the distances between adjacent securing points when the respective leaflet is not secured to the frame are less than the distances between the adjacent securing points when the respective leaflet is secured to the frame.

[0183] Example 54. The prosthetic valve of any example herein, particularly example 46, further comprising an inner skirt secured to an inner surface of the frame, wherein each of the plurality of leaflets is attached to the inner skirt via the plurality of securing points.

[0184] Example 55. The prosthetic valve of any example herein, particularly example 54, wherein each of the plurality of leaflets is sutured to the inner skirt via the plurality of securing points.

[0185] Example 56. The prosthetic valve of any example herein, particularly example 54 or 55, wherein each of the plurality of leaflets comprises 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 each of the plurality of leaflets is attached to the inner skirt at a plurality of attachment points on the inner skirt, each of the plurality of attachment points corresponding to a respective one of the plurality of securing points of the respective leaflet, wherein at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the corresponding attachment points on the inner skirt are not uniform, wherein the differences increase the closer the securing points are to the free edge and decrease the closer the securing points are to the cusp edge midpoint.

[0186] Example 57. The prosthetic valve of any example herein, particularly example 54 or 55, wherein each of the plurality of leaflets comprises 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 each of the plurality of leaflets is attached to the inner skirt at a plurality of attachment points on the inner skirt, each of the plurality of attachment points corresponding to a respective one of the plurality of securing points of the respective leaflet, wherein at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the corresponding attachment points on the inner skirt are not uniform, wherein the differences decrease the closer the securing points are to the free edge and increase the closer the securing points are to the cusp edge midpoint.

[0187] Example 58. The prosthetic valve of any example herein, particularly example 54 or 55, wherein each of the plurality of leaflets is attached to the inner skirt at a plurality of attachment points on the inner skirt, each of the plurality of attachment points corresponding to a respective one of the plurality of securing points of the respective leaflet, wherein, for eachof the plurality of leaflets, distances between adjacent securing points when the respective leaflet is not secured to the frame are greater than distances between the corresponding attachment points on the inner skirt.

[0188] Example 59. The prosthetic valve of any example herein, particularly example 58, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame, and the distances between the corresponding attachment points on the inner skirt, are such that the respective leaflet is compressed when secured to the frame.

[0189] Example 60. The prosthetic valve of any example herein, particularly example 58, wherein the distances between adjacent securing points when the respective when the respective leaflet is not secured to the frame, and the distances between the corresponding attachment points on the inner skirt, are such that folds are not formed in the respective leaflet.

[0190] Example 61. The prosthetic valve of any example herein, particularly any one of examples 58 - 60, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the corresponding attachment points on the inner skirt by up to 70%.

[0191] Example 62. The prosthetic valve of any example herein, particularly any one of examples 58 - 60, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the corresponding attachment points on the inner skirt by up to 40%.

[0192] Example 63. The prosthetic valve of any example herein, particularly example 62, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the corresponding attachment points on the inner skirt by 30 - 40%.

[0193] Example 64. The prosthetic valve of any example herein, particularly example 54 or 55, wherein each of the plurality of leaflets is attached to the inner skirt at a plurality of attachment points on the inner skirt, each of the plurality of attachment points corresponding to a respective one of the plurality of securing points of the respective leaflet, wherein, for each of the plurality of leaflets, distances between adjacent securing points when the respective leaflet is not secured to the frame are less than distances between the corresponding attachment points on the inner skirt.

[0194] Example 65. The prosthetic valve of any example herein, particularly example 46, further comprising an outer skirt secured to an inner surface of the frame, wherein each of the plurality of leaflets is attached to the outer skirt via the plurality of securing points.

[0195] Example 66. The prosthetic valve of any example herein, particularly example 65, wherein each of the plurality of leaflets is sutured to the outer skirt via the plurality of securing points.

[0196] Example 67. The prosthetic valve of any example herein, particularly example 65 or 66, wherein each of the plurality of leaflets comprises 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 each of the plurality of leaflets is attached to the outer skirt at a plurality of attachment points on the outer skirt, each of the plurality of attachment points corresponding to a respective one of the plurality of securing points of the respective leaflet, wherein at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the corresponding attachment points on the outer skirt are not uniform, wherein the differences increase the closer the securing points are to the free edge and decrease the closer the securing points are to the cusp edge midpoint.

[0197] Example 68. The prosthetic valve of any example herein, particularly example 65 or 66, wherein each of the plurality of leaflets comprises 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 each of the plurality of leaflets is attached to the outer skirt at a plurality of attachment points on the outer skirt, each of the plurality of attachment points corresponding to a respective one of the plurality of securing points of the respective leaflet, wherein at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the corresponding attachment points on the outer skirt are not uniform, wherein the differences decrease the closer the securing points are to the free edge and increase the closer the securing points are to the cusp edge midpoint.

[0198] Example 69. The prosthetic valve of any example herein, particularly example 65 or 66, wherein each of the plurality of leaflets is attached to the outer skirt at a plurality of attachment points on the outer skirt, each of the plurality of attachment points corresponding to a respective one of the plurality of securing points of the respective leaflet, wherein, for each of the plurality of leaflets, distances between adjacent securing points when the respective leaflet is not secured to the frame are greater than distances between the corresponding attachment points on the outer skirt.

[0199] Example 70. The prosthetic valve of any example herein, particularly example 69, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame, and the distances between the corresponding attachment points on the outer skirt, are such that the respective leaflet is compressed when secured to the frame.

[0200] Example 71. The prosthetic valve of any example herein, particularly example 69, wherein the distances between adjacent securing points when the respective when the respective leaflet is not secured to the frame, and the distances between the corresponding attachment points on the outer skirt, are such that folds are not formed in the respective leaflet.

[0201] Example 72. The prosthetic valve of any example herein, particularly any one of examples 69 - 71, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the corresponding attachment points on the outer skirt by up to 70%.

[0202] Example 73. The prosthetic valve of any example herein, particularly any one of examples 69 - 71, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the corresponding attachment points on the outer skirt by up to 40%.

[0203] Example 74. The prosthetic valve of any example herein, particularly example 73, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the corresponding attachment points on the outer skirt by 30 - 40%.

[0204] Example 75. The prosthetic valve of any example herein, particularly example 65 or 66, wherein each of the plurality of leaflets is attached to the outer skirt at a plurality of attachment points on the outer skirt, each of the plurality of attachment points corresponding to a respective one of the plurality of securing points of the respective leaflet, wherein, for each of the plurality of leaflets, distances between adjacent securing points when the respective leaflet is not secured to the frame are less than distances between the corresponding attachment points on the outer skirt.

[0205] Example 76. The prosthetic valve of any example herein, particularly example 46, wherein each of the plurality of leaflets is attached to the frame via the plurality of securing points.

[0206] Example 77. The prosthetic valve of any example herein, particularly example 76, wherein each of the plurality of leaflets is sutured to the frame via the plurality of securing points.

[0207] Example 78. The prosthetic valve of any example herein, particularly any one of examples 46 - 77, wherein, for each of the plurality of leaflets, each of the plurality of securing points comprises an aperture.

[0208] Example 79. The prosthetic valve of any example herein, particularly any one of examples 46 - 78, wherein each of the plurality of leaflets is not flattenable.

[0209] Example 80. The prosthetic valve of any example herein, particularly example 79, wherein each of the plurality of leaflets comprises a first face and a second face opposing the first face, and wherein, for each of the plurality of leaflets, the leaflet first face and the leaflet second face are non-developable surfaces.

[0210] Example 81. The prosthetic valve of any example herein, particularly example 46, wherein each of the plurality of leaflets comprises a first face and a second face opposing the first face, wherein, for each of the plurality of leaflets, the leaflet first face and the leaflet second face are non-developable surfaces, and wherein each of the plurality of leaflets comprises 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.

[0211] Example 82. The prosthetic valve of any example herein, particularly example 81, 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.

[0212] Example 83. The prosthetic valve of any example herein, particularly example 82, 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.

[0213] Examples 84. The prosthetic valve of any example herein, particularly any one of examples 81 - 83, wherein each of the plurality of leaflets is curved from the free edge to the cusp edge midpoint.

[0214] 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.

[0215] 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 thecontext 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.

[0216] 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 plurality of securing points, the plurality of leaflets secured to the frame via the plurality of securing points, wherein, for each of the plurality of leaflets, distances between adjacent securing points when the respective leaflet is not secured to the frame are greater than distances between the adjacent securing points when the respective leaflet is secured to the frame, wherein each of the plurality of leaflets is not flattenable.

2. The prosthetic valve of claim 1, wherein each of the plurality of leaflets comprises a first face and a second face opposing the first face, and wherein, for each of the plurality of leaflets, the leaflet first face and the leaflet second face are non-developable surfaces.

3. The prosthetic valve of any one of claims 1 - 2, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame are such that the respective leaflet is compressed when secured to the frame.

4. The prosthetic valve of claim 3, wherein the distances between adjacent securing points when the respective when the respective leaflet is not secured to the frame are such that folds are not formed in the respective leaflet.

5. The prosthetic valve of any one of claims 1 - 4, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the adjacent securing points when the respective leaflet is secured to the frame by up to 70%.

6. The prosthetic valve of claim 5, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the adjacent securing points when the respective leaflet is secured to the frame by up to 40%.

7. The prosthetic valve of claim 6, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame is greater than the distances between the adjacent securing points when the respective leaflet is secured to the frame by 30 - 40%.

8. The prosthetic valve of any one of claims 1 - 7, wherein at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the adjacent securing points when the respective leaflet is secured to the frame are uniform.

9. The prosthetic valve of claim 8, wherein all of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the adjacent securing points when the respective leaflet is secured to the frame are uniform.

10. The prosthetic valve of any one of claims 1 - 9, wherein at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the adjacent securing points when the respective leaflet is secured to the frame are not uniform.

11. The prosthetic valve of claim 1 , wherein each of the plurality of leaflets comprises 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 at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the adjacent securing points when the respective leaflet is secured to the frame are not uniform, and wherein the differences increase the closer the securing points are to the free edge and decrease the closer the securing points are to the cusp edge midpoint.

12. The prosthetic valve of claim 1, wherein each of the plurality of leaflets comprises 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 at least some of the differences between the distances between adjacent securing points when the respective leaflet is not secured to the frame and the distances between the adjacent securing points when the respective leaflet is secured to the frame are not uniform, and wherein the differences decrease the closer the securing points are to the free edge and increase the closer the securing points are to the cusp edge midpoint.

13. The prosthetic valve of claim 1 , further comprising an inner skirt secured to an inner surface of the frame, wherein each of the plurality of leaflets is attached to the inner skirt via the plurality of securing points.

14. The prosthetic valve of claim 13, wherein each of the plurality of leaflets is attached to the inner skirt at a plurality of attachment points on the inner skirt, each of the plurality of attachment points corresponding to a respective one of the plurality of securing points of the respective leaflet, wherein, for each of the plurality of leaflets, distances between adjacent securing points when the respective leaflet is not secured to the frame are greater than distances between the corresponding attachment points on the inner skirt.

15. The prosthetic valve of claim 14, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame, and the distances between the corresponding attachment points on the inner skirt, are such that the respective leaflet is compressed when secured to the frame.

16. The prosthetic valve of claim 15, wherein the distances between adjacent securing points when the respective when the respective leaflet is not secured to the frame, and the distances between the corresponding attachment points on the inner skirt, are such that folds are not formed in the respective leaflet.

17. The prosthetic valve of claim 1, further comprising an outer skirt secured to an outer surface of the frame, wherein each of the plurality of leaflets is attached to the outer skirt via the plurality of securing points.

18. The prosthetic valve of claim 17, wherein each of the plurality of leaflets is attached to the outer skirt at a plurality of attachment points on the outer skirt, each of the plurality of attachment points corresponding to a respective one of the plurality of securing points of the respective leaflet, wherein, for each of the plurality of leaflets, distances between adjacent securing points when the respective leaflet is not secured to the frame are greater than distances between the corresponding attachment points on the outer skirt.

19. The prosthetic valve of claim 18, wherein the distances between adjacent securing points when the respective leaflet is not secured to the frame, and the distances between the corresponding attachment points on the outer skirt, are such that the respective leaflet is compressed when secured to the frame.

20. The prosthetic valve of claim 19, wherein the distances between adjacent securing points when the respective when the respective leaflet is not secured to the frame, and the distances between the corresponding attachment points on the outer skirt, are such that folds are not formed in the respective leaflet.

Images