WO2025199105A1

WO2025199105A1 - Prosthetic valves and frames thereof

Info

Publication number: WO2025199105A1
Application number: PCT/US2025/020375
Authority: WO
Inventors: Nikolai Gurovich; Karin LAVON; Eran GROSU; Michael BUKIN
Original assignee: Edwards Lifesciences Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 2024-03-19
Filing date: 2025-03-18
Publication date: 2025-09-25
Anticipated expiration: 2026-09-19

Abstract

The present disclosure relates to prosthetic valves and frames thereof. In an example, a prosthetic valve comprises a frame configured to transition between a radially expanded and a crimped state, and a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve. The frame comprises a plurality of intersecting struts that include a plurality of angled struts arranged to form a plurality of circumferentially extending rungs of struts, and a plurality of axial frame members extending between an outflow rung and a second rung of angled struts. A proximally oriented shoulder defined by at least one of the plurality of axial struts and a distally oriented shoulder defined by an adjacent axial frame member define, in the crimped state, a minimal gap greater than a thickness of a leaflet of the prosthetic valve.

Description

PROSTHETIC VALVES AND FRAMES THEREOF

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63/567,804, filed March 19, 2024, which is incorporated by reference herein.

FIELD

[0002] The present disclosure relates to prosthetic valves, and in particular, to frames of prosthetic valves designed to reduce the risk of leaflet pinching between struts of the frame during crimping of the valve.

BACKGROUND

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

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

[0005] Most expandable prosthetic valves comprise a cylindrical metal frame and prosthetic leaflets mounted inside the frame. When implanted in a patient’s body, the leaflets of the prosthetic heart valve are configured to open and close (during systole and diastole, for example), in order to regulate a flow of blood through the prosthetic heart valve. SUMMARY

[0006] When a prosthetic valve is placed in a crimping apparatus to radially compress the valve to a smaller diameter for insertion into a patient, the leaflets are pressed against the inner surface of the frame and portions of the tissue can protrude into open cells of the frame between the struts and can be pinched due to the scissor-like motion of the struts. If the valve is severely crimped to achieve a small crimping size, this scissor-like motion can result in cuts and rupture of the tissue leaflets. The present disclosure is directed towards prosthetic valves comprising frames designed to reduce the risk of leaflet pinching when the valve is crimped.

[0007] In one of its basic configurations, a prosthetic valve comprises a frame configured to transition between a radially expanded and a crimped state, wherein the frame comprises a plurality of intersecting struts and configured to maintain, in the crimped state, a minimal gap between at least some of the adjacent angled struts. This basic configuration can preferably be provided with any one or more of the features described elsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and/or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0008] In some examples, the plurality of intersecting struts comprises a plurality of angled struts arranged to form a plurality of circumferentially extending rungs of struts.

[0009] In some examples, the plurality of rungs comprises an outflow rung comprising outflow struts.

[0010] In some examples, the plurality of rungs comprises a second rung distal to the outflow rung.

[0011] In some examples, the plurality of rungs comprises an inflow rung comprising inflow struts.

[0012] In some examples, the plurality of intersecting struts comprises a plurality of axial frame members extending between the outflow rung and the second rung.

[0013] In some examples, the plurality of axial frame members comprises a plurality of axial struts.

[0014] In some examples, the plurality of axial frame members comprises a plurality of commissure support members.

[0015] In some examples, the prosthetic valve comprises a valvular structure mounted inside the frame. [0016] In some examples, the valvular structure can comprise a plurality of leaflets configured to regulate flow through the prosthetic valve, wherein each leaflet has a leaflet thickness.

[0017] In some examples, an inflow edge portion of at least one of the plurality of axial struts can optionally define a proximally oriented shoulder, and an inflow edge portion of at least one of the plurality of commissure support members can optionally define a distally oriented shoulder, such that a minimal gap defined, in the crimped state, between the proximally oriented shoulder and the distally oriented shoulder of adjacent axial frame members is greater than the leaflet thickness.

[0018] In some examples, the gap defined in the crimped state between the proximally oriented shoulder and the distally oriented shoulder of adjacent axial frame members, can optionally be uniform along the lengths of the proximally oriented shoulder and the distally oriented shoulder.

[0019] In some examples, the proximally oriented shoulder can optionally be distal to the distally oriented shoulder in the crimped state.

[0020] In some examples, the proximally oriented shoulder can optionally be parallel to the distally oriented shoulder in the crimped state.

[0021] In some examples, a minimal gap defined, in the crimped state, between adjacent angled struts of the second rung, can optionally be equal to or greater than the minimal gap defined between the proximally oriented shoulder and the distally oriented shoulder of adjacent axial frame members.

[0022] In some examples, an inflow edge portion of at least one of the plurality of axial struts can optionally define a proximally oriented shoulder, and an inflow edge portion of at least one of the plurality of commissure support members can optionally define a distally oriented shoulder, such that a minimal gap defined, in the crimped state, between the inflow edge portions of adjacent axial frame members, is greater than the leaflet thickness.

[0023] In some examples, the gap defined in the crimped state between the inflow edge portions of adjacent axial frame members can optionally be uniform along the lengths of the inflow edge portions.

[0024] In some examples, the inflow edge portions of adjacent axial frame members can optionally be parallel to each other in the crimped state.

[0025] In some examples, a minimal gap defined, in the crimped state, between adjacent angled struts of the second rung, can optionally be equal to or greater than the minimal gap defined between the inflow edge portions of adjacent axial frame members. [0026] In some examples, pairs of adjacent angled struts of the same rung can optionally be configured to assume an outwardly bent configuration in the crimped state.

[0027] In some examples, each pair of adjacent angled struts of the second rung can optionally extend from a mutual horizontal strut.

[0028] In some examples, the length of the horizontal strut can optionally be within a range of 0.3 mm - 0.4 mm.

[0029] In some examples, a gap defined between ends of adjacent angled struts, opposite of the horizontal strut, can optionally be greater, in the crimped state, than the length of the horizontal strut.

[0030] In some examples, the gap defined in the crimped state between ends of adjacent angled struts, opposite of the horizontal strut, can optionally be within a range of 0.47 mm. - 0.57 mm. [0031] In some examples, the gap defined in the crimped state between ends of adjacent angled struts, opposite of the horizontal strut, can optionally be at least as great as 120% of the length of the horizontal strut.

[0032] In some examples, a gap defined in the crimped state between inflow end portions of adjacent axial frame members can optionally be equal to or greater than the gap defined between ends of adjacent angled struts, opposite of the horizontal strut.

[0033] In some examples, inner edges of adjacent angled struts extending from mutual apex regions of the frame can optionally be configured to contact each other in the crimped state, so as to maintain a gap between adjacent angled struts of at least one other rung of the frame.

[0034] In some examples, the angled struts can comprise the inner edges contacting each other in the crimped state can be the outflow struts.

[0035] In some examples, the angled struts of the at least one other rung between which the gap can optionally be maintained can be angled struts of the second rung.

[0036] In some examples, the inner edge of each outflow strut can optionally be laterally offset from the corresponding inner edge of the axial frame member extending therefrom.

[0037] In some examples, outer edges of neighboring outflow struts can optionally be spaced from each other, in the crimped state, along at least part of the length of the outflow struts.

[0038] In some examples, the angled struts comprise the inner edges contacting each other in the crimped state can optionally be the inflow struts.

[0039] In some examples, the angled struts of the at least one other rung between which the gap can optionally be maintained can be angled struts extending proximally from the inflow rung. [0040] In some examples, the inner edge of each inflow strut can optionally be laterally offset from the corresponding inner edge of the angled strut optionally extending proximally therefrom.

[0041] In some examples, one or more angled struts of a pair of adjacent angled struts extending from mutual apex regions of the frame can comprise a lateral bump configured to contact the adjacent angled strut in the crimped state, in a manner that maintains a gap between adjacent angled struts of at least one other rung of the frame.

[0042] In some examples, the lateral bumps can optionally extend from inner edges of the adjacent angled struts.

[0043] In some examples, outer edges of neighboring struts that include the lateral bumps extending from their inner edges, can optionally be devoid of lateral bumps.

[0044] In some examples, at least some of the angled struts that include lateral bumps extending from their inner edges, can comprise lateral bumps optionally extending from their outer edges.

[0045] In some examples, one lateral bump extending from one of the angled struts of the pair of angled struts can optionally define a proximally oriented edge portion.

[0046] In some examples, the lateral bump extending from one of the angled struts of the pair of angled struts can optionally be configured to engage with a complementary support member of the adjacent angled strut of the pair of angled struts, in the crimped state.

[0047] In some examples, the complementary support member can comprise a distally oriented edge portion optionally configured to contact the proximally oriented edge portion in the crimped state.

[0048] In some examples, the proximally oriented edge portion and the distally oriented edge portion can optionally have complementary shapes.

[0049] In some examples, the angled struts comprise the lateral bumps can optionally be the outflow struts.

[0050] In some examples, the lateral bumps can optionally be configured to maintain, in the crimped state, a gap between adjacent axial frame members.

[0051] In some examples, one or more of the axial frame members optionally comprises at least one lateral bump configured to contact an adjacent axial frame member in the crimped state, in a manner that maintains a gap between adjacent angled struts of the second rung.

[0052] In some examples, each axial frame member that comprises the lateral bump extending from one side thereof, optionally comprises a lateral bump extending from an opposite side thereof. [0053] In some examples, the lateral bump optionally comprises a proximally oriented edge portion.

[0054] In some examples, the lateral bumps can optionally extend from outflow end portions of the corresponding axial frame members.

[0055] In some examples, the axial frame member adjacent to the axial frame member that includes the lateral bump, can optionally be devoid of a lateral bump extending from a side facing the lateral bump.

[0056] In some examples, the proximally oriented edge portion can optionally be configured to engage, in the crimped state, a distally-oriented shoulder defined at the transition between outflow struts and the outflow end portion of the adjacent axial frame member.

[0057] In some examples, the lateral bumps can optionally extend from intermediate portions of the corresponding axial frame members.

[0058] In some examples, the lateral bump extending from one of the axial frame members can optionally be configured to engage with a complementary support member of the adjacent axial frame member, in the crimped state.

[0059] In some examples, the complementary support member optionally comprises a distally oriented edge portion optionally configured to contact the proximally oriented edge portion in the crimped state.

[0060] In some examples, the proximally oriented edge portion and the distally oriented edge portion can optionally have complementary shapes.

[0061] The aspects of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE FIGURES

[0062] Some examples of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some examples may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an example in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.

In the Figures:

[0063] Fig. 1A is a perspective side view of an exemplary prosthetic valve.

[0064] Fig. IB is a perspective view of the frame of the prosthetic valve of Fig. 1 A.

[0065] Fig. 1C is a side view of a portion of the frame of Fig. IB.

[0066] Fig. 2 shows an exemplary delivery apparatus carrying an exemplary prosthetic valve.

[0067] Fig. 3 shows a portion of an exemplary frame that includes angled stmts configured to assume a relatively straight vertical orientation in the crimped state.

[0068] Fig. 4 shows a portion of an exemplary frame that includes axial frame members defining distally oriented shoulders which are axially offset from proximally oriented shoulders of adjacent axial frame members, in the crimped state.

[0069] Fig. 5 shows a portion of an exemplary frame that includes angled stmts configured to assume an outwardly bent orientation in the crimped state.

[0070] Fig. 6 shows a portion of an exemplary frame that includes pairs of adjacent outflow stmts configured to contact each other at their inner edges in the crimped state.

[0071] Fig. 7 A shows a portion of an exemplary frame that includes pairs of adjacent inflow stmts configured to contact each other at their inner edges in the crimped state.

[0072] Fig. 7B shows a portions of the exemplary frame of Fig. 7A, with the apex regions approximated towards each other in the crimped state.

[0073] Fig. 8 shows a portion of an exemplary frame that includes outflow stmts equipped with lateral bumps extending from both sides thereof.

[0074] Fig. 9 shows a portion of an exemplary frame that includes pairs of adjacent outflow stmts that include lateral bumps extending from inner edges thereof.

[0075] Fig. 10 shows a portion of an exemplary frame that includes axial frame members equipped with lateral bumps configured to engage, in the crimped state, with distally oriented shoulder at upper end of adjacent axial frame members.

[0076] Fig. 11 shows a portion of an exemplary frame that includes axial frame members equipped with lateral bumps configured to engage, in the crimped state, with complementary support members extending from adjacent axial frame members.

[0077] Fig. 12 shows a portion of an exemplary frame that includes outflow struts equipped with lateral bumps configured to engage, in the crimped state, with complementary support members extending from adjacent outflow struts. DETAILED DESCRIPTION

[0078] 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.

[0079] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0080] 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.

[0081] As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the terms "have" or "includes" means "comprises". Further, the terms "coupled", "connected", and "attached", as used herein, are interchangeable and generally mean physically, mechanically, chemically, magnetically, and/or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. As used herein, "and/or" means "and" or "or", as well as "and" and "or". [0082] 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.

[0083] The term "plurality" or "plural" when used together with an element means two or more of the element. Directions and other relative references (e.g., inner and outer, upper and lower, above and below, left and right, and proximal and distal) may be used to facilitate discussion of the drawings and principles herein but are not intended to be limiting.

[0084] The terms "proximal" and "distal" are defined relative to the use position of a delivery apparatus. In general, the end of the delivery apparatus closest to the user of the apparatus is the proximal end, and the end of the delivery apparatus farthest from the user (e.g., the end that is inserted into a patient’s body) is the distal end. The term "proximal" when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the proximal end of the delivery apparatus. The term "distal" when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the distal end of the delivery apparatus. The terms "longitudinal" and "axial" are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0085] Throughout the figures of the drawings, different superscripts for the same reference numerals are used to denote different examples of the same elements. Examples of the disclosed devices and systems may include any combination of different examples of the same elements. Specifically, any reference to an element without a superscript may refer to any alternative example of the same element denoted with a superscript. In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component.

[0086] Figs. 1A-1C illustrate a prosthetic valve 10, according to one example. 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 optionally be crimped on or retained by an implant delivery apparatus 52 (see Fig. 2) in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site. The expanded state may include a range of diameters to which the valve may expand, between the compressed state and a maximal diameter reached at a fully expanded state. Thus, a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state.

[0087] A prosthetic valve of the current disclosure (e.g., prosthetic valve 10, 100) may include any prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve. The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve), or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0088] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Patent No. 10,363,130, which is incorporated by reference herein. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in US Publication No. 2022/0079749, which is incorporated herein by reference. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Patent No. 11,291,540, which is incorporated herein by reference.

[0089] It is to be understood that any prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses. Balloon expandable valves generally involve a procedure of inflating a balloon within a prosthetic valve, thereby expanding the prosthetic valve within the desired implantation site. Once the valve is sufficiently expanded, the balloon is deflated and retrieved along with a delivery apparatus 52 (see Fig. 2). Self-expandable valves include a frame that is shape-set to automatically expand as soon an outer retaining shaft or capsule (not shown) is withdrawn proximally relative to the prosthetic valve. Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion. The mechanical actuation mechanism usually includes a plurality of expansion and locking assemblies (such as the prosthetic valves described in U.S. Patent No. 10,603,165, International Application No. PCT/US2021/052745, and U.S. Provisional Application Nos. 63/085,947 and 63/209904, each of which is incorporated herein by reference in its entirety), releasably coupled to respective actuation assemblies of a delivery apparatus, controlled via a handle (not shown) for actuating the expansion and locking assemblies to expand the prosthetic valve to a desired diameter. The expansion and locking assemblies may optionally lock the valve's diameter to prevent undesired recompression thereof, and disconnection of the actuation assemblies from the expansion and locking assemblies, to enable retrieval of the delivery apparatus once the prosthetic valve is properly positioned at the desired site of implantation.

[0090] The prosthetic valve 10 comprises a frame 106 movable between a radially compressed state and a radially expanded state, and a valvular structure 160 mounted within the frame 106. The frame extends between an inflow end 104 and an outflow end 102, and defines a central longitudinal axis Ca extending in a direction from the inflow end 104 to the outflow end 102. In some instances, the inflow end 104 is the distal end of the frame 106, and the outflow end 102 is the proximal end of the frame 106. Alternatively, depending for example on the delivery approach of the valve, the inflow end can be the proximal end of the frame, and the outflow end can be the distal end of the frame. Fig. 1 A is a perspective view of an exemplary prosthetic valve 10 that can optionally include an inner skirt 174 disposed around an inner surface of the frame 106, an outer skirt 180 disposed around an outer surface of the frame 106, and a valvular structure 160 mounted inside the frame 106, optionally connected to the inner skirt 174. Fig. IB is a perspective view of the frame 106 of the prosthetic valve 10 of Fig. 10A. Fig. 1C is a side view of a portion of the frame 106 of Fig. IB.

[0091] 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.

[0092] 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.

[0093] 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. [0094] The term "inflow", as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve.

[0095] 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.

[0096] The terms "longitudinal" and "axial", as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0097] The frame 106 can be made of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol). When constructed of a plastically-expandable material, the frame 106 (and thus the valve 10, 100) can be crimped to a radially compressed state on a delivery catheter (e.g., delivery balloon catheter 60 shown in Fig. 2) and then expanded inside a patient by an inflatable balloon (e.g., balloon 62 shown in Fig. 2) or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 106 (and thus the valve 10, 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0098] Suitable plastically-expandable materials that can optionally be used to form the frames disclosed herein (e.g., the frame 106) include metal alloys, polymers, or combinations thereof. Example metal alloys can optionally comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 106 comprises stainless steel. In some examples, the frame 106 comprises cobalt-chromium. In some examples, the frame 106 comprises nickel-cobalt-chromium. In some examples, the frame 106 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS technologies), which is equivalent to UNS R3OO35 (covered by ASTM F562-02). MP35N™/UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0099] In the example illustrated in Figs. 1A-1C, the frame 106 is an annular, stent-like structure comprising a plurality of intersecting struts 108 which form multiple rows 146 of cells 144 between the outflow end 102 and the inflow end 104 of the frame 106. In this application, the term "strut" 108 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 108 may be any elongated member or portion of the frame 106. The frame 106 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 104 to the outflow end 102 as shown, or the frame can vary in diameter along the height of the frame, as disclosed in US Pat. No. 9,155,619, which is incorporated herein by reference.

[0100] The interconnected struts 108 include a plurality of angled struts 110 arranged in a plurality of rungs 112 of circumferentially extending rungs of angled struts, with the strut rungs 112 being arrayed along the length of the frame 106 between the outflow end 102 and the inflow end 104. Struts 108 of the frame 106 can optionally further include a plurality of axial frame members 114. The term "axial frame member" refers to a strut or a component of the frame 106 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 106. It is to be understood that the term "angled strut" encompasses both linear angled struts and curved struts.

[0101] Two or more struts 108 can intersect at junctions 148, which can be equally or unequally spaced apart from each other. The struts 108 may be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 106 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.

[0102] The valvular structure 160 can comprise a plurality of leaflets 162 (e.g., three leaflets), positioned at least partially within the frame 106, and configured to regulate flow of blood through the prosthetic valve 100 from the inflow end 104 to the outflow end 102. While three leaflets 162 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Figs. 1A-1C, it will be clear that a prosthetic valve 10 can include any other number of leaflets 162. Adjacent leaflets 162 can be arranged together to form commissures 172 that are coupled (directly or indirectly) to respective portions of the frame 106, thereby securing at least a portion of the valvular structure 160 to the frame 106. In some examples, each leaflet 162 can optionally comprise opposing tabs 170, wherein each tab 170 can be secured to an adjacent tab 170 of an adjacent leaflet 162 to form a commissure 172 that is secured to the frame 106.

[0103] Each leaflet 162 can further include a free edge portion 164 on a portion of the leaflet 162 between the two tabs 170 and closest to the outflow end 102 of the frame 106, and a cusp edge portion 166 extending between the two tabs 170 opposite to the free edge portion 164. In some examples, the cusp edge portion 166 can optionally have an undulating, curved scalloped shape. A leaflet inflow end portion 168 is defined as the distal-most portion of the leaflet 162 along the cusp end portion 166. In some examples, the leaflet inflow end portion 168 can optionally be defined at the middle of the

[0104] The leaflets 162 can optionally define a non-planar coaptation plane (not annotated) when the free edge portions 164 of the leaflets coapt or mate with each other to seal blood flow through the prosthetic valve 10. During diastole, the adjacent free edge portions 164 should coapt with each other to prevent retrograde blood from flowing between the free edge portions 164. During systole, the adjacent free edge portions 164 will separate from each other and allow antegrade blood to flow between free edge portions 164.

[0105] The leaflets 162 can optionally be made from, in whole or part, biological material (e.g., pericardium), bio-compatible synthetic materials, or other such materials. Further details regarding transcatheter prosthetic heart valves, including the manner in which the valvular structure 160 can be coupled to the frame 106 of the prosthetic valve 10, can be found, for example, in U.S. Patent Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,652,202, and 11,135,056, all of which are incorporated herein by reference in their entireties.

[0106] The frame 106 includes an outflow cell row, which is the first cell row 146a in the illustrated example, an inflow cell row, which is represented by the fourth cell row 146d in the illustrated example, and optionally (but not necessarily) one or more additional cell rows therebetween. A frame can include less or more than four rows of cells, such that the inflow cell row is not necessarily the fourth cell row, but can be any other distal-most row of cells.

[0107] In the example illustrated in Figs. 1 A-1C, the frame 106 is shown to comprises four cell rows 146, each row comprising a plurality of cells 144 extending circumferentially such that each cell 144 is directly coupled to two circumferentially adjacent cells 144 on both sides thereof within the same row of cells. The term "cell", as used herein, refers to a closed cell, having an enclosed perimeter defined by at least four struts 108. The first or outflow cell row 146a (upper in the orientation shown in Figs. 1A-1C), disposed at the outflow end 102, comprises outflow cells 144a that are elongated in an axial direction (relative to the central longitudinal axis Ca), compared to cells 144 in the remaining cell rows 146, which can include a second cell row 146b, a third cell row 146c, and a fourth cell row 146d.

[0108] In some examples, such as shown in Figs. 1A-1C, each cell row 146 comprises twelve cells 144. Thus, the frame 106 can be referred to as a twelve-cell frame. In other examples, the frame 106 can have a greater or fewer number of circumferentially extending cell rows 146 and/or a greater or fewer number of cells 144 in each cell row. [0109] In some examples, cells 144 are coupled to adjacent cells 144 within the same row, such as within the outflow (or proximal-most) cell row 146a, via axial frame members 114. Axial frame members 114 include, in some examples, commissure support members 132 and non-commissural axial struts 122. A commissure support member 132 is configured to support a corresponding commissure 172 of the valvular structure 160. The axial frame members 114, including non-commissural axial struts 122 and commissure support members 132, can optionally be parallel to each other and/or to the central longitudinal axis Ca of the frame 106. [0110] In some examples, a commissure support member 132 can optionally comprise a commissure window opening 134 defined between two axially-extending commissure sidewalls 136. While commissure support members 132 that include commissure window openings 134 are illustrated and described herein, it is to be understood that a frame 106 can include other types of commissure support members configured to mount a commissure 172 in any other suitable manner, such as by supporting portions of the valvular structure 160 that can be wrapped therearound, can include apertures through which sutures for attaching the commissures can be passed, and the like. The terms "non-commissural axial strut" and "axial strut", as used herein, are interchangeable, and refer to an axial frame member configured to remain unattached to the valvular structure 160. That is to say, an axial struts 122 is not configured to mount a commissure, and may be devoid of a window opening 134.

[0111] The frame 106 includes an outflow rung, which is the first rung 112a in the illustrated example, an inflow rung, which is represented by the fifth rung 112e in the illustrated example, and one or more additional rungs therebetween, which can be referred to as intermediate rungs. A frame can include less or more than five rungs, such that the inflow rung is not necessarily the fifth rung, but can be any other distal-most rung.

[0112] In the example illustrated in Figs. 1 A- 1C, the frame 106 is shown to comprise five rungs 112 of angled struts 110, including a first or outflow rung 112a of angled struts which is closer to the outflow end 102 relative to other rungs of struts, a second rung 112b of angled struts which is distal to the first rung 112a, a third rung 112c of angled struts which is distal to the second rung 112b, a fourth rung 112d of angled struts which is distal to the third rung 112c, and a fifth rung 112e, also termed herein an inflow rung 112e, which includes angled struts that are closer to the inflow end 104 relative to other rungs of struts.

[0113] One or more (for example, two, as shown in Figs. 1A-1C) axial struts 122 can be positioned between, in the circumferential direction, two commissure support members 132. In some examples, each axial strut 122 can have a width that is larger than a width of the angled struts 110. As used herein, a “width” of a strut is measured between opposing locations on opposing surfaces of a strut that extend between the radially facing inner and outer surfaces of the strut (relative to the central axis Ca). A “thickness” of a strut is measured between opposing locations on the radially facing inner and outer surfaces of a strut and is perpendicular to the width of the strut. In some examples, the width of the axial struts 122 is 50-200%, 75-150%, or at least 100% larger than (e.g., double) the width of the angled struts 110 of the frame 106. [0114] By providing the axial struts 122 with the width that is greater than the width of other, angled struts 110 of the frame 106, a larger contact area is provided for when the leaflets 162 contact the wider axial struts 122 during systole, thereby distributing the stress and reducing the extent to which the leaflets may fold over the axial struts 122, radially outward through the outflow cells 144a. As a result, a long-term durability of the leaflets can be increased.

[0115] The outflow cells 144a of the outflow cell row 146a of the exemplary frame 106 illustrated in Figs. 1A-1C are shown to be generally hexagonal, each cell defined between two outflow angled struts 110a of the outflow rung 112a, two angled struts 110b of the second rung 112b, and two axial frame members 114 extending between the outflow rung 112a and the second rung 112b. Cells of the second cell row 146b, third cell row 146c, and fourth or inflow cell row 146d, can be generally diamond- shaped cells, with the cells 144 of the second cell row 146b defined by two intermediate angled struts 110 of the second rung 112b and two intermediate angled struts 110 of the third rung 112c, cells 144 of the third cell row 146c defined by two intermediate angled struts 110 of the third rung 112c and two intermediate angled struts 110 of the fourth rung 112d, and inflow cells 144d of the inflow cell row 146d defined by two intermediate angled struts 110 of the fourth rung 112d and two angled struts 1 lOe of the inflow rung 112e.

[0116] Each rung 112 of angled struts 110 is shown to be circumferentially arranged in a generally zig-zagged pattern. Each axial frame member 114 can have an outflow end portion 116 at which the axial frame member 114 is linked to outflow angled struts 110a of the outflow rung 112a, and an inflow end portion 120 at which the axial frame member 114 is linked to angled struts 110b of the second rung 112b.

[0117] Adjacent angled struts 110 can define an angle therebetween that can change between the expanded and crimped states. The term "adjacent angled struts" refers to a couple of angled struts 110 of the same rung 112, diverging from a mutual junction 148. For example, adjacent angled struts 110b of the second rung 112b can define an angle |3 therebetween, which can change be defined between angle p_e in the expanded state shown in Fig. 1C, to a smaller angle p_c in the crimped state (an example of which is shown in Fig. 5). [0118] As mentioned above, while three rows 146 of cells 144 defined between five rungs 112 of angled struts 110 are illustrated, it is to be understood that any exemplary prosthetic valve disclosed herein can include any other number of cell rows 146 and strut rungs 112.

[0119] In some examples, the prosthetic valve 10 can optionally include an inner skirt 174 secured to an inner surface of the frame 106. The inner skirt 174 extends between a skirt inflow end portion 178 which is at or closer to the inflow end 104 of the frame 106, and a skirt outflow end portion 176 which is closer to the outflow end 102 of the frame 106. The inner skirt 174 can function as a sealing member to prevent or decrease perivalvular leakage, to anchor the valvular structure 160 to the frame 106, and/or to protect the leaflets 162 against damage caused by contact with the frame 106 during crimping and during working cycles of the prosthetic valve 10. In some examples, cusp edge portions 166 of the leaflets 162 can be sutured to the inner skirt 174 generally along a scallop-shaped line. The inner skirt 174 can in turn be coupled to the frame 106 by one or more fasteners, such as sutures. In some examples, an inner skirt 174 comprises a single sheet of material that extends continuously around frame 106. In some examples, the inner skirt 174 can optionally comprise one or more skirt portions that are connected together and/or individually connected to the frame 106.

[0120] In some examples, the prosthetic valve 10 can further include an outer skirt 180 disposed around an outer surface of the frame 106, and configure to function, for example, as a sealing member retained between the frame 106 and the surrounding tissue of the native annulus against which the prosthetic valve is mounted, thereby reducing risk of paravalvular leakage (PVL) past the prosthetic valve 10. In some examples, the outer skirt 180 comprises a single sheet of material that extends continuously around the frame 106. In some examples, the outer skirt 180 can optionally comprise one or more skirt portions that are connected together and/or individually connected to the frame 106.

[0121] Any of an inner skirt 174 and/or outer skirt 180 can optionally comprise various suitable biocompatible materials, such as, but not limited to, natural tissue (e.g. pericardial tissue), a fabric, or polymeric material (such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc.). [0122] It is to be understood that an inner skirt and an outer skirt are shown and described herein by way of illustration and not limitation. For example, a prosthetic valve 10 can optionally be provided with an inner skirt 174 and without an outer skirt, in which case, the inner skirt 174 further serves as a PVL sealing member of the valve against the surrounding anatomy. Similarly, a prosthetic valve 10 can optionally be provided with an outer skirt 180 and without an inner skirt, in which case, the leaflet's cusp edge portion 166 can be optionally directly coupled (e.g., sutured) to struts 108 of the frame 106. [0123] In some examples, the inflow end portion 120 of an axial frame member 114 can optionally comprise an aperture 182. The apertures 182 can be configured to receive fasteners (e.g., sutures) for attaching soft components of the prosthetic valve 10 to the frame 106. For example, in some instances, the outer skirt 180 can be positioned around the outer surface of the frame 106 and an upper or outflow edge portion of the outer skirt 180 can be secured to the apertures 182 by fasteners (e.g., sutures).

[0124] In some examples, the stiffness of the frame 106 can be increased to withstand radial resistive and crushing forces and to increase the longevity of the valvular structure, particularly when the prosthetic valve is deployed to larger diameters (e.g., from about 29 mm to about 31 mm). In some examples, the outflow angled struts 110a at the can optionally be thicker and/or wider than the remaining angled struts HOb-llOe.

[0125] In some examples, the interconnected struts 108 can optionally further comprise horizontal struts 142 that extend between adjacent cells 144 of a cell row 146. The horizontal struts 142 can extend in a circumferential direction and also be referred to as circumferentially extending struts 142. The horizontal struts 142 can connect angled struts of two adjacent rungs of angled struts of the frame 106 to one another. For example, each horizontal strut 142 can connect to two angled struts of one row of struts (for example, angled struts 110b of second rung 112b) and two angled struts in another, adjacent row of struts (for example, angled struts 110c of rung 112c). As a result, an angled strut 110b extending between commissure support member 132 and the horizontal strut 142 and an angled strut 110c extending between the horizontal strut 142 and another horizontal strut 142 disposed closer to the inflow end 104 of the frame 106 can be aligned along an angled line that can follow a scallop line of the leaflets (when the leaflets are attached to the frame 106). Thus, the horizontal struts 142 can allow the angled struts to follow a shape that more closely matches a shape of the scallop line of the leaflets when the frame 106 is in the radially expanded configuration. Additionally, the horizontal struts 142 can serve as spacers that can maintain a specified gap between the angled struts when the frame 106 is in the radially compressed configuration, thereby reducing a risk of pinching the leaflets between the struts in the radially compressed configuration.

[0126] As shown, the frame 106 can optionally comprise a plurality of apex regions 150 formed at the outflow and inflow ends 102, 104 of the frame 106. Each apex region 150 extends and forms a junction between two outflow angled struts 110a at the outflow end 102 or two inflow angled struts 1 lOe at the inflow end 104. As such, the apex regions 150 are spaced apart from one another around a circumference of the frame 106 at the outflow end 102 and the inflow end 104. [0127] Each apex region 150 can optionally comprise an apex 152 (the highest or most outward extending, in an axial direction, point) and two thinned (or narrowed) strut portions 154, one thinned strut portion 154 extending from either side of the apex 152 to a corresponding, wider, outflow angled stmt 110a (at the outflow end 102) or inflow angled stmt IlOe (at the inflow end 104). In this way, each of the apex regions 150 at the outflow end 102 can form a narrowed transition region between and relative to the two outflow angled struts 110a extending from the corresponding apex region 150 and each of the apex regions 150 at the inflow end 104 can form a narrowed transition region between and relative to the two inflow angled stmts 1 lOe extending from the corresponding apex region 150.

[0128] In some examples, each apex region 150 can optionally comprise a curved, axially facing outer surface 156 and an arcuate or curved, axially facing inner depression 158 which forms the thinned stmt portions 154. The curved inner depressions 158 can optionally be formed on a cell side of the apex region 150 (e.g., as opposed to the outside of the apex region 150).

[0129] In some examples, the curved outer surface 156 of each apex region 150 can optionally form a single, continuous curve from one angled stmt 110 on a first side of the apex region 150 to another angled stmt 110 on an opposite, second side of the apex region 150. For example, the curved outer surface 156 can optionally have a constant convex curvature. The term "constant convex curvature", as used herein, refers to a continuously curved surface which is convex and which does not have an inflection point (no change in direction of the curvature). [0130] In some examples, each of the outflow angled stmts 110a can optionally have a width greater than a width of the intermediate angled stmts HOb-llOd. The width of the outflow angled stmts 110a increases the stiffness of the outflow end 102 of the frame 106. Such a configuration advantageously provides greater radial resistive force and cmsh resistance at the outflow end 102 of the prosthetic valve 10 (which in some prosthetic valves is more prone to fatigue/failure), while the intermediate angled stmts HOb-llOd remain narrower (and thus less stiff). The less stiff intermediate angled stmts 110b-l lOd can prevent or mitigate leaflet tearing during balloon expansion (as could potentially occur if the entire frame 106 were stiffer). For example, balloon expansion of some prosthetic valves can result in tearing of the leaflets if the expanding balloon presses them against an overly stiff mid-portion of the frame, particularly in the case of large diameter valves. Stiffening the outflow angled stmts 110a while retaining the less stiff intermediate angled stmts HOb-llOd advantageously provides the desired radial resistance/cmsh resistance at the outflow end 102 without decreasing the longevity of the leaflets. [0131] In some examples, the inflow angled struts IlOe can optionally also have increased stiffness relative to the intermediate angled struts HOb-l lOd. In some examples, the inflow angled struts 1 lOe can optionally have a width greater than the width of the intermediate angled struts 110b-l lOd, but less than the width of the outflow angled struts 110a. In other examples, the inflow angled struts IlOe can optionally have a width that is equal to or greater than the width of the outflow angled struts 110a.

[0132] Increasing the stiffness of the inflow angled struts IlOe further increases the overall stiffness of the frame 106 without specifically stiffening the intermediate angled struts 1 10b- HOd, which is advantageous for the reasons described above.

[0133] Another advantage provided by the stiffened outflow angled struts 110a and/or inflow angled struts IlOe is that they can facilitate synchronized deployment (e.g., the expansion of the outflow and inflow end portions of the frame 106 at the same or substantially the same rate), thereby allowing the frame 106 to assume a uniform cylindrical expansion profile. This can prevent an undesired hourglass or V-shaped frame configuration.

[0134] In some examples, inner edges of angled outflow struts 110a can be laterally offset from the corresponding edges continuously extending therefrom along the outflow end portions 116 of the axial frame members 114, optionally defining outflow edge portions 124 that transition from a wider neck portion at the lower end of the outflow struts 110a connected to a single axial frame member 114, towards a narrower width of the corresponding outflow end portion 116 of the axial frame member 114, each outflow edge portion 124 thereby defining a distally- oriented shoulder 126. The distally-oriented shoulders 126 can be generally curved in shape as illustrated, though any other shape is contemplated.

[0135] In some examples, the inflow end portion 120 of one or more of, or each of, the axial struts 122, can optionally be wider than the intermediate portion 118. In such cases, the axial strut 122 can optionally define inflow edge portions 128 that transition from the wider inflow end portion 120 towards the intermediate portion 118, on both lateral sides of the axial strut 122, each inflow edge portion 128 thereby defining a proximally-oriented shoulder 130. The proximally-oriented shoulders 130 can be generally curved in shape as illustrated, though any other shape is contemplated.

[0136] In some examples, a width between lateral outer edges of the commissure sidewalls 136 of one or more of, or each of, the commissure support members 132, can optionally be greater than the width of the inflow end portion 120 of the corresponding commissure support member 132. In such cases, the commissure support member 132 can optionally define inflow edge portions 138 that transition from the narrower inflow end portion 120 towards commissure sidewalls 136, on both lateral sides of the commissure support member 132, each inflow edge portion 138 thereby defining a distally-oriented shoulder 140. The distally-oriented shoulders 140 can be generally curved in shape as illustrated, though any other shape is contemplated.

[0137] Fig. 2 shows a perspective view of an exemplary delivery assembly 50 that includes a delivery apparatus 52 adapted to deliver a prosthetic device, which can be the prosthetic valve 10 described above, or any exemplary prosthetic valve 100 described below with respect to Figs. 4-12. The delivery apparatus 52 can optionally include a handle 54 and at least one catheter extending therefrom, configured to carry a prosthetic valve 10, 100 in a crimped state through the patient’s vasculature. An exemplary delivery assembly 50 comprises an exemplary delivery apparatus 52 configured to carry a balloon expandable prosthetic valve. The delivery apparatus 52 can optionally comprise a balloon catheter 60 having an inflatable balloon 62 mounted on its distal end. A prosthetic device, such as prosthetic valve 10, 100, can be optionally carried in a crimped state over the balloon catheter 60.

[0138] In some examples, a delivery apparatus 52 further comprises an outer shaft 58. Optionally, an outer shaft 58 of a delivery apparatus 52 can concentrically extend over the balloon catheter 60.

[0139] The outer shaft 58 and the balloon catheter 60 can optionally be configured to be axially movable relative to each other. For example, a proximally oriented movement of the outer shaft 58 relative to the balloon catheter 60, or a distally oriented movement of the balloon catheter 60 relative to the outer shaft 58, can expose the prosthetic valve 10, 100 from the outer shaft 58.

[0140] A delivery apparatus 52 can optionally further include a nosecone 64 to facilitate advancement of the delivery apparatus 52 through the patient’s vasculature to the site of treatment. A nosecone shaft (concealed from view in Fig. 2) can optionally extend proximally from the nosecone 64 through a lumen of the balloon catheter 60, towards the handle 54.

[0141] In Fig. 2, a prosthetic valve 10, 100 is mounted on the balloon 62 and is shown in a crimped state, providing prosthetic valve 10, 100 with a reduced diameter for delivery to the heart via the patient’s vasculature. While the prosthetic valve 10, 100 is shown in Fig. 2 as being crimped or mounted on the balloon 62 for delivery to the treatment location, it should be understood that the prosthetic valve can be optionally crimped or mounted at a location different from the location of balloon 62 (e.g., proximal to the balloon 62) and repositioned over the balloon at some time before inflating the balloon and deploying the prosthetic valve. This off-balloon delivery allows the prosthetic valve to be crimped to a lower profile than would be possible if the prosthetic valve was crimped on top of the balloon 62. The lower profile permits the clinician to more easily navigate the delivery apparatus (including the crimped prosthetic valve) through a patient’s vasculature to the treatment location. The lower profile of the crimped prosthetic valve can be particularly helpful when navigating through portions of the patient's vasculature which are particularly narrow, such as the iliac artery.

[0142] The proximal ends of the balloon catheter 60, the outer shaft 58, and/or the nosecone shaft, can optionally be coupled to the handle 54. During delivery, the handle 54 can be maneuvered by an operator (e.g., a clinician or a surgeon) to axially advance or retract components of the delivery apparatus 52, such as the nosecone shaft, the outer shaft 58, and/or the balloon catheter 60, through the patient's vasculature and/or along the target site of implantation, as well as to inflate the balloon 62 mounted on the balloon catheter 60, for example to expand a prosthetic valve 10, 100 mounted on the balloon 62, and to deflate the balloon 62 and retract the delivery apparatus 52, for example once the prosthetic valve 10, 100 is mounted in the implantation site.

[0143] The handle 54 can optionally include a steering mechanism configured to adjust the curvature of a distal end portion of the delivery apparatus 52. In the illustrated example, the handle 54 includes an adjustment member, such as the illustrated rotatable knob 56a, which in turn is operatively coupled to the proximal end portion of a pull wire (not shown). The pull wire can optionally extend distally from the handle 54 through the outer shaft 58 and has a distal end portion affixed to the outer shaft 58 at or near the distal end of the outer shaft 58. Rotating the knob 56a can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 52. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Pat. No. 9,339,384, which is incorporated by reference herein.

[0144] In some examples, the handle 54 can include an adjustment member such as the illustrated rotatable knob 56b, configured to adjust the axial position of the balloon catheter 60 relative to the outer shaft 58, for example for fine positioning at the implantation site. The handle can include additional knobs to control additional components of the delivery apparatus 52. Further details on the delivery apparatus 52 can be found in PCT Application No. PCT/US2021/047056, which is incorporated by reference herein.

[0145] A prosthetic valve 10, 100 can be carried by the delivery apparatus 52 during delivery in a crimped state, and expanded, for example by balloon inflation, to secure it in a native heart valve annulus (such as an aortic annulus) or against a previously implanted prosthetic valve (for example, during valve-in-valve implantation procedures). In some examples, the balloon 62 is secured to a distal end portion of the balloon catheter 60 at its proximal end, while the balloon's distal end can optionally be coupled, directly or indirectly, to another component of the delivery apparatus 52, such as the nosecone 64 or nosecone shaft.

[0146] Balloon 62 is configured to transition between a deflated and inflated states. Upon reaching the site of implantation, the balloon 62 can be inflated to radially expand the prosthetic valve 10, 100. Once the prosthetic valve 10, 100 is expanded to its functional diameter within a native annulus, the balloon 62 can be deflated, and the delivery apparatus 52 can be retrieved from the patient's body.

[0147] In some examples, the delivery apparatus 52 with the prosthetic valve 10, 100 assembled thereon, can be packaged in a sterile package that can be supplied to end users for storage and eventual use. In some examples, when the leaflets of the prosthetic valve are made from, or include at least an inner core made from, bovine pericardium tissue or other natural or synthetic tissues, the leaflets can be treated during the manufacturing process so that they are completely or substantially dehydrated and can be stored in a partially or fully crimped state without a hydrating fluid. In this manner, the package containing the prosthetic valve and the delivery apparatus, can be free of any liquid. Methods for treating tissue leaflets for dry storage are disclosed in U.S. Pat. Nos. 8,007,992 and 8,357,387, both of which documents are incorporated herein by reference.

[0148] When a prosthetic valve is placed in a crimping apparatus (not shown) to radially compress the valve to a smaller diameter for insertion into a patient, the leaflets 162 are pressed against the inner surface of the frame 106 and portions of the tissue can protrude into the open cells 144 of the frame between the struts 108 and can be pinched due to the scissor- like motion of the struts 108, particularly along the outflow cells 144a. If the valve is severely crimped to achieve a small crimping size, this scissor-like motion can result in cuts and rupture of the tissue leaflets. Disclosed herein are frames of prosthetic valves designed to reduce the risk of leaflet pinching when the valve is crimped. The term "crimped state", as used herein, refers to a state of the prosthetic valve after being compressed, optionally by a suitable crimping apparatus, to a diameter suitable for insertion and delivery through a patient’s vasculature, by a delivery apparatus, to the target site of implantation.

[0149] Fig. 3 shows a portion of a frame 106 of an exemplary prosthetic valve 10, including horizontal struts 142 and angled struts 110 that can optionally assume a relatively straight vertical orientation when the frame is radially compressed (or crimped). When the angled struts 110 assume the relatively straight vertical orientation (in the axial direction) in the crimped state of the valve 10, a length LH of the horizontal strut 142 can be specified to retain a minimal gap S 1 between the angled struts, such as between angled struts 110b of the second rung 112b. The minimal gap SI can reduce a crimp profile of the frame 106 while avoiding pinching leaflets between the angled struts in the crimped state. The horizontal struts can optionally be dimensioned to retain a minimal gap SI within a range of about 0.2 mm. - 0.7 mm. or about 0.3 mm. - 0.4 mm.

[0150] In some examples, the minimal gap SI in the crimped state can be a function of the prosthetic valve’s leaflet thickness, and can account for compressibility of the tissue of the leaflet. For example, for a leaflet having a thickness of about 0.4 mm., a minimal gap SI can be optionally designed to accommodate a leaflet folded over itself, which may require a gap of at least 0.8 mm. However, if the tissue has about 50% compressibility, it may be sufficient to design for a minimal gap of about 0.4 mm.

[0151] In some examples, a leaflet 162 axially extends along at least a portion of the outflow cell 144a, optionally having its free edge portion 164 terminating at or in close proximity to an upper end of the commissure window opening 134. In such cases, the leaflet 162 can optionally protrude through a portion of the outflow cell 144a that includes at least part of the space between adjacent angled struts 110b of the second rung 112b and optionally at least part of the space between adjacent axial frame members 114 on both sides of the outflow cell 144a. Thus, it may be desirable to maintain a minimal gap between angled struts 110b of the second rung 112b and between axial frame members 114 disposed on both sides of the outflow cell 144a, at least between the inflow end portion 120 and at least part of the intermediate portion 118 of the adjacent axial frame members.

[0152] In some cases, a minimal gap defined between adjacent struts along cells through which a portion of a leaflet can protrude in the crimped state, may be small enough so as to pose a risk of pinching the leaflet. For example, the minimal gap defined between adjacent struts configured to assume the relatively straight vertical orientation, as shown in Fig. 3, may be smaller than a minimal gap required to avoid pinching the leaflets. Moreover, when the gap S 1 is primarily dictated by the length Ln of horizontal struts 142, portions of the cells which are distanced from the horizontal struts 142, such as the inflow end portion 120 and/or intermediate portions 118 of adjacent axial frame members 114 may be less affected by horizontal struts 142, such that under crimping forces, gaps formed therebetween can be smaller than the length LH of horizontal struts 142, posing a risk of pinching leaflets extending therethrough.

[0153] While angled struts 110 of the prosthetic valve exemplified in Fig. 3 are shown to assume a relatively straight vertical orientation, some types of prosthetic valves can be designed to include angled struts configured to assume an inwardly bent orientation (not shown), which can pose a similar risk of leaflet pinching. [0154] The shape of various struts of the frame, such as portions of axial frame members, may also lead to local narrowed gaps defined therebetween in the crimped state, posing a similar risk of leaflet pinching in such cases, as described below.

[0155] When the angled struts 110b of the second rung 112b assume the relatively straight vertical orientation (in the axial direction) in the crimped state of the valve 10, as illustrated in Fig. 3, a uniform gap SI is defined between adjacent angled struts 110b, which can optionally be substantially equal to the length Ln of the horizontal strut 142. The gap between adjacent axial frame members 1 14 can optionally be also equal to or greater than the gap S I at least along a portion of the height of the axial frame members 114, terminating at the axial level of the free edge portion 164 of the leaflets 162, such as between the inflow end portions 120 and the intermediate end portions 118 of the corresponding axial frame members 114.

[0156] In some examples, some of the outflow cells 144a can be defined, each, between two axial struts 122. In some examples, some of the outflow cells 144a can be defined, each, between two commissure support members 132. In some examples, some of the outflow cells 144a can be defined, each, between a commissure support member 132 and an axial strut 122. [0157] In some cases, distally oriented shoulders 140 defined by inflow edge portions 138 of a commissure support member 132 and proximally oriented shoulder 130 defined by inflow edge portion 128 of axial struts 122 might be at least partially axially aligned with each other in the crimped state. In such a case, as shown in Fig. 3, a minimal gap S2 defined in the crimped state between a distally-oriented shoulder 140 and a corresponding proximally oriented shoulder 130 on both sides of the same outflow cell 144a can be narrower than the minimal gap SI defined between the adjacent angled struts 114b, such that a minimal gap SI between the angled struts 114b, which can optionally be uniform along the vertical length of the struts 114b, may be narrowed to a smaller minimal gap S2 (e.g., S2 < SI) between adjacent shoulders 140 and 130, and can optionally widen to a larger gap, such as a gap that can be equal to or greater than the minimal gap SI, along the intermediate portions 118. The narrower gap S2 between the shoulders 140 and 130 may be small enough to pose a risk of pinching a portion of a leaflet extending between these shoulders.

[0158] In extreme cases, inflow end portions 120 of adjacent axial frame members 114 may be even in contact with each other, completely closing the gap therebetween in the crimped state of the valve. For example, al least part of an inflow edge portion 138 along an inflow portion 120 of a commissure support member 132 can be in direct contact with an inflow edge portion 128 of an inflow portion 120 of an adjacent axial strut 122, thereby further increasing the damage that may be caused to a leaflet pinched therebetween during crimping of the valve. [0159] Described herein are prosthetic valves 100 that include frames designed to define a minimal gap along cell portions through which leaflets can extend, so as to avoid pinching the leaflets in the crimped state of the prosthetic valve 100. A prosthetic valve 100 according to any of the examples described below with respect to Figs. 4-12, can be structurally and functionally similar to any example described above with respect to prosthetic valve 10, except that the frames 106 of a prosthetic valve 100 can optionally include features and/or shape design of some struts or portions thereof that can avoid a risk of leaflet pinching in the crimped state. Other components and features of prosthetic valve 100, including valvular structure 160 with leaflets 162, optional inner skirt 174, and optional outer skirt 180, can be similar to the same components, with the same component numerals, and features thereof, described above with respect to prosthetic valve 10, and in the interest of brevity will not be described further. [0160] Various exemplary implementations for prosthetic valve 100 and/or components thereof can be referred to, throughout the specification, with superscripts, for ease of explanation of features that refer to such exemplary implementations. It is to be understood, however, that any reference to structural or functional features of any device, apparatus or component, without a superscript, refers to these features being commonly shared by all specific exemplary implementations that can be also indicated by superscripts. In contrast, features emphasized with respect to an exemplary implementation of any device, apparatus or component, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary implementations.

[0161] Fig. 4 shows a portion of a frame 106^a of an exemplary prosthetic valve 100^a. The prosthetic valve 100^a can be structurally and functionally similar to any example of prosthetic valve 10 described above, except that distally oriented shoulders 140 defined by the inflow edge portion 138 is axially offset from the proximally oriented shoulder 130 of the inflow edge portion 128.

[0162] In some examples, the angled struts 110 of the frame 106^a are configured to assume a relatively straight vertical orientation (in the axial direction) in the crimped state of the valve 100^a, defining a uniform gap S 1 between adjacent angled struts 110 as shown in Fig. 4, though it is to be understood that other orientations of adjacent angled struts 110 are contemplated.

[0163] In contrast to the configuration illustrated for exemplary prosthetic valve 10 in Fig. 3, the distally-oriented shoulder 140 of the prosthetic valve 100^a is sufficiently proximally offset from the adjacent proximally oriented shoulder 130, as illustrated in Fig. 4, such that a minimal gap S2 between adjacent inflow edge portion 138 and 128 is wide enough to avoid accidental leaflet pinching therebetween. In some examples, the distally-oriented shoulder 140 is offset from the proximally oriented shoulder 130 such that a uniform minimal gap S2 is defined between the adjacent inflow edge portion 138 and 128 of corresponding inflow end portion 120 of respective commissure support member 132 and the adjacent axial strut 122. In some examples, the minimal gap S2 between adjacent inflow edge portions 138, 128 is equal to or greater than the minimal gap SI between adjacent angled struts 110b of the second rung 112b. [0164] The axial offset between the shoulders 140 and 130 can be optionally achieved by proximally offsetting the commissure window opening 134 along with the commissure sidewalls 136 and the distally-oriented shoulder 140 as illustrated in Fig. 4, relative to their axial positions illustrated in Fig. 3, and/or by distally offsetting the proximally oriented shoulder 130.

[0165] Fig. 5 shows a portion of a frame 106^b of an exemplary prosthetic valve 100^b. The prosthetic valve 100^b is similar to any example described herein for prosthetic valve 10 or prosthetic valve 100, except that angled struts 110 of the frame 106^b are configured to assume an outwardly bent orientation in the crimped state. Thus, while exemplary valves 10 and 100^a are illustrated in Figs. 3 and 4, respectively, to have parallel angled struts 110b along the second rung 112b in the crimped state, corresponding to a zero crimped-angle p_c therebetween, the struts 110b define a positive angle p>_c in the crimped state in the example illustrated for prosthetic valve 100^b in Fig. 5.

[0166] Frame 106^b can optionally include horizontal struts 142. As illustrated in Fig. 5, angled struts 110 of the same rung 112 can diverge from each other when axially extending away from a junction 148 that can optionally include a mutual horizontal strut 142 interconnected therebetween, such that a minimal gap SI between adjacent angled struts 110 is defined proximate to horizontal strut 142 from which the angled struts 110 diverge, and can optionally be equal to, or slightly greater than, the length LH of the corresponding horizontal strut 142. [0167] In the crimped state, each couple of angled struts 110b of the second rung 112b defined on both sides of a respective outflow cell 144a diverge from each other such that the gap S2 between their upper (or proximal) ends, and/or between the corresponding inflow end portions 120 of the respective adjacent axial frame members 114, is greater than the gap SI between their lower (or distal) ends, proximate the corresponding horizontal strut 142. In some examples, the gap defined between the intermediate portions 118 of the adjacent axial frame members 114 on both sides of the outflow cell 114a is substantially equal, in the crimped state, to the gap S2 between their respective inflow end portions 120.

[0168] As further illustrated in Fig. 5, each couple of angled struts extending along both sides of a cell which is distal to the outflow cell row 146a, such as cells 144 along the second cell row 146b, third cell row 146c, and/or fourth cell row 146d, can diverge from each other such that a gap S3 defined at an axial center of the cell 144 (or optionally another intermediate axial height of the cell) is greater than the gap SI at the proximal and/or distal ends of the cell 144. In some examples, the gap S2 is substantially equal to the gap S3.

[0169] In some examples, a frame 106^b can be designed to form outwardly bent angled struts 110 in the crimped state by modifying the size of the horizontal struts 142. For example, a horizontal strut 142 of the prosthetic valve 10 of Fig. 3 can have a length LH of about 0.45 mm. The minimal gap S 1 of the valve 10 illustrated in Fig. 3 can optionally have a uniform value of 0.45 mm. between adjacent angled struts 110b of the second rung 112b, or, for the case of a prosthetic valve 10 equipped with angled struts configured to assume an inwardly bent orientation in the crimped state, the gap can be reduced from about 0.45 mm. in close proximity to the horizontal strut, to about 0.4 mm. at the end of the angled struts 110 opposite to the horizontal strut 142. Compared to such an example of the prosthetic valve 10, the frame 106^b of prosthetic valve 100^b can optionally include horizontal struts having a smaller length LH, such as a length LH of about 0.34 mm, such that the lateral distance between adjacent angled struts 110 of a frame 106^b can widen, in the crimped state, from a gap SI of about 0.34 mm. to a gap S2 and/or gap S3 of about 0.52mm.

[0170] It is to be understood that any reference to a length LH of a horizontal strut 142 disclosed herein, refers to the lateral length of the strut 142 between the angled struts 110 interconnected thereby, and excluding the widths of the angled struts 110 themselves.

[0171] In some examples, the length LH of a horizontal strut 142 of frame 106^b is within a range of about 0.3 mm - 0.4 mm. In some examples, the length Ln of a horizontal strut 142 of frame 106^b is within a range of about 0.32 mm - 0.36 mm. In some examples, the length LH of a horizontal strut 142 of frame 106^b is equal to about 0.34 mm. In some examples, the length LH of a horizontal strut 142 is smaller than the thickness of a leaflet 162 of the valve 100^b. In some examples, the gap S2, S3 between adjacent angled struts 110 at an end of the angled struts 110 opposite to the horizontal strut 142 connecting the angled struts 110 to each other, is greater than the length LH of the horizontal strut 142. In some examples, the gap S2, S3 is within a range of about 0.47 mm. - 0.57 mm. In some examples, the gap S2, S3 is within a range of about 0.5 mm. - 0.54 mm. In some examples, the gap S2, S3 is equal to about 0.52 mm. In some examples, the gap S2, S3 is at least as great as 120% of the length LH of a horizontal strut 142. In some examples, the gap S2, S3 is at least as great as 130% of the length LH of a horizontal strut 142. In some examples, the gap S2, S3 is at least as great as 150% of the length LH of a horizontal strut 142. In some examples, the length LH of a horizontal strut 142 is within a range of about 0.32 mm - 0.36 mm, and the gap S2, S3 is within a range of about 0.47 mm.

- 0.57 mm. In some examples, the length LH of a horizontal strut 142 is smaller than the thickness of leaflet 162, and the gap S2, S3 is greater than the thickness of leaflet 162.

[0172] While the gap between adjacent angled struts 110 may be smaller along a portion of the cell 144 that is closer to the horizontal strut 142, the risk of a leaflet 162 being pinched along such smaller gap is relatively low due to the fact that the portion of the leaflet that is closer to the horizontal strut 142 and the narrower gap regions in close proximity thereto, is not likely to extend radially through the cell 144 along such regions, as the horizontal strut 142 and the portions of the angled struts 110 diverging therefrom, yet extending close to each other in relative close proximity to each other at these regions, will prevent radial leaflet extension at these regions. The slope of the outwardly bent angled struts 110 and the values of the gaps SI and S2 at both ends of the angled struts 110 can be designed such that the gap between adjacent angled struts 110 is large enough to reduce risk of pinching along regions which are closer to the widest gaps S2, S3.

[0173] In some cases, a portion of the leaflet 162 which is closer to the leaflet inflow end portion 168 may protrude through the inflow cell 144d, posing a similar risk of being pinched by angled struts 110 of the inflow cell 144d in the crimped state. When a leaflet 162 is sutured along the cusp edge portion 166 to an inner skirt 174, the leaflet may protrude through the cell's opening along with a corresponding portion of the inner skirt to which it is attached.

[0174] In some examples, as illustrated in Fig. 5, a couple of inflow angled struts I lOe along the inflow rung 112e diverge from the apex region 150 at the inflow end 104 of the frame 106^b so as to define the wider gap S3 at the center (or other axial position at which the inflow angled struts 1 lOe terminate) of the corresponding inflow cell 144d. A wider gap S3 defined along the inflow cells 144d in the crimped state can allow a portion of a leaflet 162 to protrude therethrough with reduced risk of being pinched. When the leaflet 162 is sutured to an inner skirt 174, the size of the gap S3 in the crimped state can be designed to account for the thickness of both the leaflet 162 and the inner skirt 174.

[0175] The term "adjacent angled struts", as used herein, refers to two angled struts 110 along the same rung 112 which can be optionally connected to each other at a junction 148 or an apex region 150, wherein no other angled strut 110 is disposed between the adjacent angled struts. The term "adjacent axial frame members", as used herein, refers to two circumferentially spaced axial frame members 114 that do not include any additional axial frame members disposed therebetween. [0176] In some examples, adjacent outflow angled struts 110a can optionally include stopper features configured to prevent further compression of the frame, or at least an outflow portion of the frame, when a crimped state is achieved, in a manner that maintains a desired minimal gap between some adjacent angled struts 110 and/or adjacent axial frame members 114, designed to avoid or at least reduce the likelihood of pinching the leaflets.

[0177] In some examples, adjacent inflow outflow angled struts I lOe can optionally include stopper features configured to prevent further compression of the frame, or at least an inflow portion of the frame, when a crimped state is achieved, in a manner that maintains a desired minimal gap between some adjacent angled struts 110 and/or adjacent axial frame members 114, designed to avoid or at least reduce the likelihood of pinching the leaflets.

[0178] In some examples, adjacent axial frame members 114 can optionally include stopper features configured to prevent further compression of the frame, or at least an outflow portion of the frame, when a crimped state is achieved, in a manner that maintains a desired minimal gap between some adjacent angled struts 110 and/or adjacent axial frame members 114, designed to avoid or at least reduce the likelihood of pinching the leaflets.

[0179] The term "outflow portion of the frame", as used herein, refers to a portion of the frame 106 that includes the outflow cell row 146a. Stated otherwise, the outflow portion of a frame includes the outflow rung 112a of angled struts 110a, the axial frame members 114, and the second rung 112b of angled struts 110b.

[0180] In some examples, the frame can be designed to have an angle 0_e (indicated, for example, in Fig. 1C) between adjacent angled struts 110b of the second rung 112b which is relatively large in the expanded state, such that after crimping of the valve, the resulting angle Pc in the crimped state, between the same adjacent angled struts 110b, will still be positive, as illustrated in Fig. 5.

[0181] The term "inflow portion of the frame", as used herein, refers to a portion of the frame 106 that includes the inflow cell row 146d. Stated otherwise, the inflow portion of a frame includes the inflow rung 112e of angled struts IlOe, and the rung of angled struts which is proximal to, and extending from, the inflow rung, such as the fourth rung 112d of angled struts 1 lOd for the case of an exemplary frame 106 having a total of five rungs of angled struts.

[0182] Fig. 6 shows a portion of a frame 106^c of an exemplary prosthetic valve 100^c. The prosthetic valve 100^c is similar to any example described herein for prosthetic valve 100, except that couples of adjacent outflow angled struts 110a extending from common apex regions 150 at the outflow end 102 if the frame 106^c are configured to contact each other in the crimped state, such that a minimal gap is defined between adjacent angled struts 110b of the second rung 112b and/or adjacent axial frame members 114.

[0183] Angled struts 110b of the second rung 112b define a width LSM, which can optionally be equal to the width of angled struts of other intermediate rungs, such as the third 112c and/or fourth 112d rungs, or can optionally be different than the width of angled struts along at least one other intermediate rung. The outflow angled struts 110a of the frame 106^c are shown in Fig. 6 to have a width Lso that is greater than the width LSM of the angled struts 110b of the second rung 1 12b, and optionally wider than the width of any other angled struts of all intermediate rungs.

[0184] As shown in Fig. 6, S4 designates the minimal gap between adjacent axial frame members, and SI designates the minimal gap between adjacent angled struts 110b of the second rung 112b. The gaps SI and S4 are continuous with each other, and can optionally be substantially equal to each other (e.g., S1=S4). The minimal gap S4 can optionally be defined between the intermediate portions 118 and/or the inflow end portion 120 of adjacent axial frame members 114.

[0185] The width Lso of adjacent outflow angled struts 110a is increased for frame 106^c, relative to their width in the illustrated examples in Figs. 3-5, for example, towards each other, such that as the frame is compressed, the inner edges of the adjacent struts 110a (i.e., the edges facing each other) get closer, until the outflow struts 110a contact each other along their inner edges in the fully crimped state. When the valve 100^c is in the crimped state, the outflow angled struts 110a and their inner edges can optionally assume a substantially vertical orientation that can be substantially parallel to the axial frame members 114 they extend from.

[0186] The inner edges of adjacent outflow struts 110a are sufficiently offset, in the lateral direction, from the inner edges of the corresponding axial frame members 114, such that in the crimped state, gap S4 separates between the inner edges of adjacent axial frame members 114, and gap SI separates between adjacent corresponding angled struts 110b of the second rung 112b, wherein gaps S4 and/or SI cannot be further reduced since the contacting edges of the outflow angled struts 110a function as stoppers that prevent further compression of the frame, at least along the outflow portion of the frame 106^c. The term "lateral", as used herein, refers to the circumferential direction when the frame assumes its substantially cylindrical configuration.

[0187] The term "inner edge", as used herein with reference to an inner edge of an outflow angled strut 110a, refers to the edge of the strut 110a facing an adjacent angled strut 110a that extends from the same apex region 150 of the outflow end 102 of the frame. An inner edge of a corresponding axial frame member 114 refers to an edge of the axial frame member which is continuous with the inner edge of the outflow angled struts 110a.

[0188] The term "outer edge", as used herein with reference to an outer edge of an outflow angled strut 110a, refers to the edge opposite to the inner edge of the strut 110a. Stated otherwise, an outer edge of an angled strut 110a is an edge facing a neighboring outflow angled strut 110a that extends from a different neighboring apex region 150 of the outflow end 102 of the frame. Two separate outflow angled struts 110a that extend from the same axial frame member 1 14 will have their corresponding outer edges facing each other.

[0189] In some examples, the inner edge of an outflow angled strut 110a is laterally offset from the inner edge of the corresponding axial frame member 114 in the crimped state. In some examples, the inner edge of an outflow angled strut 110a is laterally offset from the inner edge of the corresponding axial frame member 114 by a size that is substantially equal to half the minimal gap S4. In some examples, the inner edge of an outflow angled strut 110a is laterally offset from the inner edge of the corresponding axial frame member 114 by a size that is substantially equal to half the minimal gap SI. In some examples, the minimal gap S4 achieved when inner edges of adjacent outflow angled struts 110a contact each other in the crimped state, is greater than the thickness of leaflet 162. In some examples, the minimal gap SI achieved when inner edges of adjacent outflow angled struts 110a contact each other in the crimped state, is greater than the thickness of leaflet 162.

[0190] While the inner edges of adjacent outflow angled struts 110a are configured to contact each other in the crimped state, the outer edges of neighboring outflow angled struts 110a can optionally be spaced from each other in a vertical orientation of the angled struts 110a, as illustrated in Fig. 6.

[0191] In some examples, the width Lsi of the inflow angled struts IlOe can be optionally smaller than the width Lso of the outflow angled struts 110a. In some examples, the width Lsi of the inflow angled struts IlOe can be optionally smaller than the width Lso of the outflow angled struts 110a but greater than the width LSM of at least some of the angled struts along the intermediate rungs 112, such as angled struts of any of the rungs 112b, 112c, and/or 112d. In some examples, the width Lsi of the inflow angled struts 1 lOe can be optionally substantially equal to the width of at least some of the angled struts along the intermediate rungs 112, such as angled struts of any of the rungs 112b, 112c, and/or 112d. In some examples, the width Lsi of the inflow angled struts IlOe can be optionally substantially equal to the width of LSM of the angled struts 110b of the second rung 112b, as illustrated in Fig. 6. [0192] Fig. 7A shows a portion of a frame 106^d of an exemplary prosthetic valve 100^d. The prosthetic valve 100^d is similar to any example described herein for prosthetic valve 100, except that couples of adjacent inflow angled struts 110a extending from common apex regions 150 at the inflow end 104 if the frame 106^d are configured to contact each other in the crimped state, such that a minimal gap is defined between adjacent angled struts 110 which are proximal to, and extending from, the inflow angled struts I lOe, such as angled struts l lOd of the fourth rung 112d.

[0193] The inflow angled struts 1 lOe of the frame 106^d are shown in Fig. 7 A to have a width Lsi that is greater than the width LSM of other angled struts of the intermediate rungs, such as angled struts 110 of the second 112b, third 112c, and/or fourth 112d rungs.

[0194] The width Lsi of adjacent inflow angled struts 1 lOe is increased for frame 106^d, relative to their width in the illustrated examples in Figs. 3-5, for example, towards each other, such that as the frame is compressed, the inner edges of the adjacent inflow angled struts 1 lOe get closer, until the inflow struts IlOe contact each other along their inner edges in the fully crimped state. When the valve 100^d is in the crimped state, the inflow angled struts I lOe and their inner edges can optionally assume a substantially vertical orientation.

[0195] The term "inner edge", as used herein with reference to an inner edge of an inflow angled strut IlOe, refers to the edge of the strut IlOe facing an adjacent angled strut I lOe that extends from the same apex region 150 of the inflow end 104 of the frame. An inner edge of a corresponding angled strut 1 lOd proximally extending from the inflow angled strut 1 lOe refers to an edge of the angled strut 1 lOd which is continuous with the inner edge of the inflow angled struts IlOe.

[0196] The term "outer edge", as used herein with reference to an outer edge of an inflow angled strut I lOe, refers to the edge opposite to the inner edge of the strut I lOe. Stated otherwise, an outer edge of an angled strut 1 lOe is an edge facing a neighboring inflow angled strut 110a that extends from a different neighboring apex region 150 of the inflow end 104 of the frame.

[0197] In some examples, the inner edge of an inflow angled strut IlOe is laterally offset from the inner edge of the corresponding angled strut extending proximally therefrom, such as a corresponding angled strut l lOd of the fourth rung 112d, in the crimped state. In some examples, the inner edge of an inflow angled strut IlOe is laterally offset from the inner edge of the corresponding angled strut llOd extending proximally therefrom by a size that is substantially equal to half the minimal gap between adjacent angled struts HOd extending proximally from the outflow rung 112e, which can optionally be substantially similar to gap S3 described above with respect to Fig. 5. In some examples, the minimal gap achieved between adjacent angled struts HOd extending proximally from the outflow rung 112e when inner edges of adjacent inflow angled struts I lOe contact each other in the crimped state, is greater than the thickness of leaflet 162. In this manner, inflow angled struts I lOe can be optionally shaped and dimensioned to allow them to serve as stoppers that prevent further compression along an inflow portion of the frame.

[0198] While the inner edges of adjacent inflow angled struts I lOe are configured to contact each other in the crimped state, the outer edges of neighboring inflow angled struts 1 lOe can optionally be spaced from each other in a vertical orientation of the angled struts IlOe, as illustrated in Fig. 7B.

[0199] The compressive forces applied to the valve during crimping can optionally facilitate, in some cases, bending of the outflow struts 110a and/or the inflow struts IlOe towards each other, orienting the corresponding apex regions 150 closer to each other, as illustrated for example in Fig. 7B . This can be achieved for the outflow struts 110a by maintaining a sufficient distance between their outer edges, as shown in the flattened configuration of the frame portions in Figs. 6 and 7A, and can be achieved for the inflow struts I lOe by maintaining a sufficient distance between their outer edges, as shown in the flattened configuration of the frame portion in Fig. 7A. By allowing the apex regions 150 to move radially inwards during crimping, a risk of apex region 150 frictionally engaging with and/or accidentally scraping surfaces surrounded thereby during delivery of the prosthetic valve to the site of implantation, such as, for example, an inner surface of a delivery sheath or catheter, can be reduced.

[0200] It is to be understood that the term "angled struts" as used herein, refers to an angled orientation assumed by such struts in the expanded state of the frame, as shown for example in Figs. 1A-1C, while in the crimped state, at least some of these struts can optionally assume a relatively vertical orientation (e.g., substantially parallel to each other). This is in contrast to axial frame members that remain oriented in a vertical orientation throughout both crimped and expanded states. The terms "outflow angled struts" and "outflow struts", as used herein, are interchangeable. The terms "inflow angled struts" and "inflow struts", as used herein, are interchangeable.

[0201] While Figs. 7A and 7B show an exemplary frame that include both inflow angled struts and outflow angled struts configured to contact each other at inner edges thereof in the crimped state, it is to be understood that in some examples, a frame can include inflow angled struts IlOe configured to contact each other at their inner edges in the crimped state, as described herein with respect to Fig. 7A, while the outflow angled struts 110a can be relatively narrower and not necessarily configured to similarly contact each other at their inner edges.

[0202] While the inflow angled struts 1 lOe are illustrated in Figs. 7A-7B to contact each other, in the crimped state, in a manner that maintains a minimal gap between angled struts HOd of the fourth rung 112d extending proximally therefrom, it is to be understood that a frame can include other numbers of rungs 112, such that the minimal gap is maintained between angled struts 110 of any appropriate rung which proximally extends from the inflow rung.

[0203] In some examples, angled struts 1 10 extending from apex region 150, such as outflow struts 110a and/or inflow struts HOe, can include lateral bumps 184 laterally extending from their inner edges, and optionally their outer edges as well. The lateral bumps 184 can serve as stopper features configured to contact each other in a similar manner to that described for inner edges of outflow struts 110a and/or inflow struts 1 lOe with respect to Figs. 6-7B, except instead of such struts having relatively uniform increased widths Lso and/or Lsi along their lengths, the lateral bumps 184 form a shorter region of contact between adjacent struts.

[0204] Fig. 8 shows a portion of a frame 106^e of an exemplary prosthetic valve 100^e. The prosthetic valve 100^e is similar to any example described herein for prosthetic valve 100, except that angled struts 110 extending from apex regions 150 comprise lateral bumps 184^e extending laterally from the inner and the outer edges of the angled struts. For example, outflow angled struts 110a are shown in Fig. 8 to include lateral bumps 184^e which are configured to contact each other in the crimped state, such that a minimal gap is defined between adjacent angled struts 110b of the second rung 112b and/or adjacent axial frame members 114, which can be referred to as minimal gaps SI and S4 described above with respect to Fig. 6.

[0205] When the valve 100^e is in the crimped state, the outflow angled struts 110a and their inner edges can optionally assume a substantially vertical orientation that can be substantially parallel to the axial frame members 114 they extend from. As further illustrated in Fig. 8, each outflow strut 110a is shown to include an inner lateral bump 184^ea extending laterally from its inner edge, and an outer lateral bump 184^eb extending laterally from its outer edge.

[0206] The inner bumps 184^ea of adjacent outflow struts 110a are sufficiently offset, in the lateral direction, from the inner edges of the corresponding axial frame members 114, such that in the crimped state, gap S4 separates between the inner edges of adjacent axial frame members 114, and gap SI separates between adjacent corresponding angled struts 110b of the second rung 112b, wherein gaps S4 and/or SI cannot be further reduced since the contacting inner lateral bumps 184^ea function as stoppers that prevent further compression of the frame, at least along the outflow portion of the frame 106^e. [0207] In some examples, the lateral end of an inner lateral bump 184^ea is laterally offset from the inner edge of the corresponding axial frame member 114 in the crimped state, optionally by a size that is substantially equal to half the minimal gap S4. In some examples, the lateral end of an inner lateral bump 184^ea is laterally offset from the inner edge of the corresponding axial frame member 114 by a size that is substantially equal to half the minimal gap SI. In some examples, the minimal gap S4 achieved when inner edges of adjacent outflow angled struts 110a contact each other in the crimped state, is greater than the thickness of leaflet 162. In some examples, the minimal gap SI achieved when inner edges of adjacent outflow angled struts 110a contact each other in the crimped state, is greater than the thickness of leaflet 162. [0208] As further illustrated in Fig. 8, the outer lateral bumps 184^eb of neighboring outflow struts 110a can optionally be configured to contact each other in the crimped state as well. Such a configuration can ensure a relatively vertical orientation of the outflow struts 110a in the crimped state, when desired.

[0209] While outflow struts 110a of a frame 106^e are described above and illustrated in Fig. 8 to include lateral bumps 184^e, it is to be understood that in some examples, the inflow struts 1 lOe can similarly include inner lateral bumps 184^ea extending laterally from their inner edges, and outer lateral bumps 184^eb extending laterally from their outer edge, either instead of or in addition to lateral bumps 184^e of outflow struts 110a. Inner lateral bumps 184^ea of inflow struts IlOe can maintain a desired minimal gap between adjacent angled struts extending proximally therefrom, while outer lateral bumps 184^eb of inflow struts I lOe can optionally ensure a relatively vertical orientation of the inflow struts I lOe in the crimped state, when desired.

[0210] Fig. 9 shows a portion of a frame 106^f of an exemplary prosthetic valve 100^f. The prosthetic valve 100^f is similar to any example described herein for prosthetic valve 100^e, except that angled struts 110 extending from apex regions 150 comprise inner lateral bumps 184^f extending laterally from the inner edges of the angled struts, while the outer edges can optionally remain substantially linear and devoid of outer lateral bumps. For example, each couple of adjacent outflow struts 110a that extend from a mutual apex region 150 are shown in Fig. 9 to include inner lateral bumps 184^fa and 184^fb facing each other, configured to contact each other in the crimped state, such that a minimal gap is defined between adjacent angled struts 110b of the second rung 112b and/or adjacent axial frame members 114, which can be referred to as minimal gaps SI and S4 described above with respect to Figs. 6 and 8.

[0211] While the lateral bumps 184^f of adjacent outflow struts 110a are configured to contact each other in the crimped state, the outer edges of neighboring outflow struts 110a can optionally be spaced from each other in a vertical orientation of the outflow struts 110a, as illustrated in Fig. 9. This spacing can allow further approximation of the apex regions 150 towards each other during crimping of the prosthetic valve 100^f, in a similar manner to that described above with respect to Fig. 7B.

[0212] While outflow struts 110a of a frame 106^f are described above and illustrated in Fig. 9 to include inner lateral bumps 184^f, it is to be understood that in some examples, the inflow struts IlOe can similarly include inner lateral bumps 184^f extending laterally from their inner edges, while their outer edges can optionally be devoid of lateral bumps, either instead of or in addition to inner lateral bumps 184^f of outflow stmts 110a. Inner lateral bumps 184^f of inflow stmts I lOe can maintain a desired minimal gap between adjacent angled stmts extending proximally therefrom, while relatively straight outer edges of neighboring inflow stmts 1 lOe can be sufficiently spaced from each other to allow for further approximation of the apex regions 150 towards each other during crimping, in a similar manner to that described above with respect to Fig. 7B.

[0213] In some examples, selected axial frame members 114 can include lateral bumps 184 laterally extending from their edges, configured to serve as stopper features that can optionally contact complementary edges of adjacent axial frame members.

[0214] Fig. 10 shows a portion of a frame 106^g of an exemplary prosthetic valve 100^g. The prosthetic valve 100^g is similar to any example described herein for prosthetic valve 100, except that at least some of the axial frame members 114 include lateral bumps 184^s extending laterally (e.g., sideways) from their outflow end portion 116. In some examples, the lateral bumps 184^s can optionally extend in opposite lateral directions from both sides of the outflow end portions 116. In some examples, the lateral bumps 184^g extend from an upper-most of proximal-most portion of the outflow end portions 116.

[0215] Any axial frame member 114 adjacent to an axial frame member 114 that includes a lateral bump 184^g, can be devoid of a similar bump, at least along the side of the outflow end portion 116 facing the lateral bump 184^g, and optionally define, instead, an outflow edge portions 124 that forms a distally-oriented shoulder 126.

[0216] In the crimped state, the lateral bumps 184^g are configured to contact edges of the outflow end portions 116 of adjacent axial frame members 114, such that a minimal gap is defined between adjacent angled struts 110b of the second rung 112b and/or the corresponding intermediate portions 118 and/or inflow end portions 120 of the adjacent axial frame members 114, which can be referred to as minimal gaps SI and S4 described above with respect to Fig. 6. [0217] In some examples, about half of the axial frame members 114 can include lateral bumps 184^s, while the other half may remain devoid of such bumps, in which case, the axial frame members 114 with and without the lateral bumps 184^s can be alternately arranged around the circumference of the frame 106^g. Fig. 10 illustrates an exemplary arrangement wherein an axial frame member 114-2, devoid of lateral bumps, is disposed between axial frame members 114- 1 and 114-2, each including lateral bumps 184^s extending from their outflow end portions 116. In this exemplary arrangement, the axial frame member 114-1 is shown to be a commissure support member 132 that includes lateral bumps 184^g, the axial frame member 114-2 is shown to be an axial strut 122 which is devoid of lateral bumps, and the axial frame member 114-3 is shown to be an axial strut 122 that includes lateral bumps 184^g. It is to be understood that any axial frame member 114 that includes lateral bumps 184^s or is devoid of such bumps, can be either an axial strut 122 or a commissure support member 132, and that the arrangement of Fig. 10 is merely shown by way of illustration and not limitation, while any other arrangement is contemplated.

[0218] The lateral bump 184^s can laterally terminate, relative to the remainder of the edge it extends from, at a distance that can be equal to a gap S4 that separates between the corresponding intermediate portions 118 and/or inflow end portions 120, and/or sized such that a desired gap SI separates between adjacent corresponding angled struts 110b of the second rung 112b, wherein gaps S4 and/or SI cannot be further reduced since the lateral bumps 184^g function as stoppers that prevent further compression of the frame, at least along the outflow portion of the frame 106^g.

[0219] In some examples, an axial frame member 114 can include two oppositely directed lateral bumps 184^s. For example, axial frame member 114-3 is illustrated in Fig. 10 to include a first lateral bump 184^sa extending from one side of its outflow end portion 116, and a second lateral bump 184^gb extending from opposite side of its outflow end portion 116. In some examples, an axial frame member 114 can include a single lateral bump 184^g extending from one side of its outflow end portion 116, while the opposite side can be devoid of a bump, and can be optionally contacted, in the crimped state, by a lateral bump of an adjacent axial frame member.

[0220] In some examples, the minimal gap S4 achieved when a lateral bump 184^g extending from an outflow end portion 116 of an axial frame member 114 contact the corresponding edge of an outflow end portion 116 of an adjacent axial frame member 114 in the crimped state, is greater than the thickness of leaflet 162. In some examples, the minimal gap SI achieved when a lateral bump 184^g extending from an outflow end portion 116 of an axial frame member 114 contact the corresponding edge of an outflow end portion 116 of an adjacent axial frame member 114 in the crimped state, is greater than the thickness of leaflet 162.

[0221] As further shown in Fig. 10, the lateral bump 184^s further defines a proximally oriented edge portion 186, which can be optionally configured to abut, in the crimped state, a distally oriented shoulder 126 of a corresponding outflow edge portion 124 defined by the adjacent axial frame member 114. The proximally oriented edge portion 186 and the distally oriented shoulder 126 can optionally have complementary shapes. While a curved proximally oriented edge portion 186 is illustrated in Fig. 10, having a curvature that can optionally be similar to that of a corresponding distally oriented shoulder 126, it is to be understood that any other shape is contemplated.

[0222] During crimping of the prosthetic valve 100⁸, the proximally oriented edge portions 186 and the distally oriented shoulders 126 of adjacent axial frame members 114 can be approximated to each other such that when they contact each other in the crimped state, their axial position is locked, while portions along the circumference of the valve in which the proximally oriented edge portions 186 and the distally oriented shoulders 126 are still spaced from each other, can continue advancement towards each other until they abut each other as well. In this manner, axial alignment of the frame can be advantageously achieved, reducing the risk of non-symmetrical expansion of the frame that can otherwise occur when different portions along the circumference of the valve are unevenly compressed.

[0223] Fig. 11 shows a portion of a frame 106^h of an exemplary prosthetic valve 100^h. The prosthetic valve 100^h is similar to any example described herein for prosthetic valve 100, except that at least some of the axial frame members 114 include lateral bumps 184^h that define proximally oriented edge portions 186, configured to engage, in the crimped state, with distally oriented edge portions 190 of complementary support members 188^h extending from adjacent axial frame members 114. In some examples, any of the lateral bumps 184¹¹ and complementary support members 188^h can optionally extend (e.g., sideways) from the intermediate portions 118 (as illustrated) or the outflow end portion 116. In some examples, lateral bumps 184^h can optionally extend in opposite lateral directions from both sides of the intermediate portions 118 (as illustrated) or the outflow end portion 116. In some examples, complementary support members 188^h can optionally extend in opposite lateral directions from both sides of the intermediate portions 118 (as illustrated) or the outflow end portion 116.

[0224] In the crimped state, the lateral bumps 184^h are configured to contact the complementary support members 188^h of adjacent axial frame members 114, such that a minimal gap is defined between adjacent angled struts 110b of the second rung 112b and/or between portions of adjacent axial frame members 114 which are distal to the axial position of the lateral bumps 184^h, which can be referred to as minimal gaps SI and S4 described above with respect to Fig. 6.

[0225] When any of the lateral bumps 184^h and complementary support members 188^h extend from the intermediate portions 118 of the axial frame members 114, their axial position along the intermediate portions 118 is such that in the crimped state of the valve, they are positioned proximal to (e.g., above) the leaflets 162, such as above the level of the free edge portions 164, so as to avoid a risk of pinching portions of the leaflet that may protrude through the outflow cells 144a during crimping.

[0226] In some examples, about half of the axial frame members 114 can include lateral bumps 184^h, while the other half can include complementary support members 188^h, in which case, the axial frame members 114 with the lateral bumps 184^h and with the complementary support members 188^h can be alternately arranged around the circumference of the frame 106^h. It is to be understood that any axial frame member 114 that includes lateral bumps 184^h and/or complementary support members 188^h, can be either an axial strut 122 or a commissure support member 132, and that an arrangement depicted in Fig. 11 is merely shown by way of illustration and not limitation, while any other arrangement is contemplated.

[0227] The size and shape of the lateral bump 184^h and the complementary support members 188^h can be configured such that a gap S4 separates between the corresponding intermediate portions 118 at a level distal to their axial position, and/or inflow end portions 120, and/or such that a desired gap SI separates between adjacent corresponding angled struts 110b of the second rung 112b, wherein gaps S4 and/or S 1 cannot be further reduced since the lateral bumps 184^h and complementary support members 188^h together function as stoppers that prevent further compression of the frame, at least along the outflow portion of the frame 106^h.

[0228] In some examples, an axial frame member 114 can include two oppositely directed lateral bumps 184^h, such as lateral bumps 184^ha and 184^hb extending from opposite side of an axial frame member 114 illustrated in Fig. 11. In some examples, an axial frame member 114 can include two oppositely directed complementary support members 188^h, such as complementary support members 188^ha and 188^hb extending from opposite side of an axial frame member 114 illustrated in Fig. 11. In some examples, an axial frame member 114 can include a single lateral bump 184^h extending from one side thereof, while the opposite side can include a single complementary support member 188^h.

[0229] In some examples, the minimal gap S4 achieved when a lateral bump 184^h contacts the corresponding complementary support member 188^h of an adjacent axial frame member 114 in the crimped state, along a portion of the axial frame member 114 distal to the lateral bump 184^h and/or the complementary support member 188^h, is greater than the thickness of leaflet 162. In some examples, the minimal gap SI achieved when a lateral bump 184^h contacts the corresponding complementary support member 188^h of an adjacent axial frame member 114 in the crimped state, is greater than the thickness of leaflet 162.

[0230] As further shown in Fig. 11, a proximally oriented edge portion 186 of the lateral bump 184^h can optionally be configured to abut, in the crimped state, a distally oriented edge portion 190 of a corresponding complementary support member 188^h. The proximally oriented edge portion 186 of the lateral bump 184^h and the distally oriented edge portion 190 of the corresponding complementary support member 188^h can optionally have complementary shapes. While curved shapes of exemplary proximally oriented edge portions 186 and distally oriented edge portions 190 are illustrated in Fig. 11, it is to be understood that any other shape is contemplated.

[0231] During crimping of the prosthetic valve 100^h, the proximally oriented edge portion 186 of the lateral bump 184^h and the distally oriented edge portion 190 of the complementary support member 188^h of adjacent axial frame members 114 can be approximated to each other such that when they contact each other in the crimped state, their axial position is locked, while portions along the circumference of the valve in which the proximally oriented edge portions 186 and the distally oriented edge portion 190 are still spaced from each other, can continue advancement towards each other until they abut each other as well. In this manner, axial alignment of the frame can be advantageously achieved.

[0232] Fig. 12 shows a portion of a frame 106¹ of an exemplary prosthetic valve 100¹. The prosthetic valve 100¹ is similar to any example described herein for prosthetic valve 100, except that couples of angled struts 110 extending from a mutual apex regions 150 comprise inner lateral bumps 184¹ and inner complementary support members 188¹ extending laterally, towards each other, from the inner edges of the adjacent angled struts, while the outer edges can optionally remain substantially linear and devoid of outer lateral bumps and/or complementary support members. For example, each couple of adjacent outflow struts 110a that extend from a mutual apex region 150 are shown in Fig. 12 to include an inner lateral bump 184¹ extending from one of the outflow struts, and an inner complementary support member 188¹ extending from the adjacent outflow strut, both of which are facing each other and configured to contact each other in the crimped state, such that a minimal gap is defined between adjacent angled struts 110b of the second rung 112b and/or adjacent axial frame members 114, which can be referred to as minimal gaps S 1 and S4 described above with respect to Figs. 6 and 8.

[0233] In some examples, the inner lateral bumps 184¹ define proximally oriented edge portions 186 configured to engage, in the crimped state, with distally oriented edge portions 190 of the inner complementary support members 188¹ extending from adjacent angled struts, in a similar manner to that described above with respect to prosthetic valve 100^h, mutatis mutandis.

[0234] While the lateral bumps 184¹ and complementary support members 188¹ of adjacent outflow struts 110a are configured to contact each other in the crimped state, the outer edges of neighboring outflow struts 110a can optionally be spaced from each other in a vertical orientation of the outflow struts 110a, as illustrated in Fig. 12. This spacing can allow further approximation of the apex regions 150 towards each other during crimping of the prosthetic valve 100¹, in a similar manner to that described above with respect to Fig. 7B.

[0235] In some examples, the minimal gap S4 achieved when a lateral bump 184¹ contacts the corresponding complementary support member 188' of an adjacent outflow strut 110a in the crimped state, is greater than the thickness of leaflet 162. In some examples, the minimal gap SI achieved when a lateral bump 184¹ contacts the corresponding complementary support member 188¹ of an adjacent outflow strut 110a in the crimped state, is greater than the thickness of leaflet 162.

[0236] As further shown in Fig. 12, a proximally oriented edge portion 186 of the inner lateral bump 184¹ can optionally be configured to abut, in the crimped state, a distally oriented edge portion 190 of a corresponding inner complementary support member 188¹. The proximally oriented edge portion 186 of the inner lateral bump 184¹ and the distally oriented edge portion 190 of the corresponding inner complementary support member 188¹ can optionally have complementary shapes. While curved shapes of exemplary proximally oriented edge portions 186 and distally oriented edge portions 190 are illustrated in Fig. 12, it is to be understood that any other shape is contemplated.

[0237] During crimping of the prosthetic valve 100¹, the proximally oriented edge portion 186 of the inner lateral bump 184¹ and the distally oriented edge portion 190 of the inner complementary support member 188¹ of adjacent angled struts, such as adjacent outflow struts 110a, can be approximated to each other such that when they contact each other in the crimped state, their axial position is locked, while portions along the circumference of the valve in which the proximally oriented edge portions 186 and the distally oriented edge portion 190 are still spaced from each other, can continue advancement towards each other until they abut each other as well. In this manner, axial alignment of the frame can be advantageously achieved.

[0238] While outflow struts 110a of a frame 106¹ are described above and illustrated in Fig. 12 to include inner lateral bumps 184¹ and inner complementary support members 188¹, it is to be understood that in some examples, the inflow struts 1 lOe can similarly include inner lateral bumps 184¹ and inner complementary support members 188¹ extending laterally from their inner edges, while their outer edges can optionally be devoid of lateral bumps or complementary support members, either instead of or in addition to inner lateral bumps 184¹ and inner complementary support members 188¹ of outflow struts 110a. Inner lateral bumps 184¹ and inner complementary support members 188¹ of inflow struts I lOe can maintain a desired minimal gap between adjacent angled struts extending proximally therefrom, while relatively straight outer edges of neighboring inflow struts 1 lOe can be sufficiently spaced from each other to allow for further approximation of the apex regions 150 towards each other during crimping, in a similar manner to that described above with respect to Fig. 7B.

Some Examples of the Disclosed Implementations

[0239] Some examples of above-described implementations are enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more examples below are examples also falling within the disclosure of this application.

[0240] Example 1. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, wherein the frame comprises a plurality of intersecting struts arranged between an inflow end and an outflow end of the frame, the plurality of intersecting struts comprising: a plurality of angled struts arranged to form a plurality of circumferentially extending rungs of struts, the rungs comprising: an outflow rung comprising outflow struts, a second rung distal to the outflow rung, and one or more additional rungs of angled struts; and a plurality of axial frame members extending between the outflow rung and the second rung, the axial frame members comprising: a plurality of axial struts and a plurality of commissure support members; and a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, wherein each leaflet has a leaflet thickness; wherein an inflow edge portion of at least one of the plurality of axial struts defines a proximally oriented shoulder, and an inflow edge portion of at least one of the plurality of commissure support members defines a distally oriented shoulder, such that a minimal gap defined, in the crimped state, between the proximally oriented shoulder and the distally oriented shoulder of adjacent axial frame members, is greater than the leaflet thickness.

[0241] Example 2. The prosthetic valve of any example herein, particularly of example 1, wherein the gap defined in the crimped state between the proximally oriented shoulder and the distally oriented shoulder of adjacent axial frame members, is uniform along the lengths of the proximally oriented shoulder and the distally oriented shoulder.

[0242] Example 3. The prosthetic valve of any example herein, particularly of example 1 or 2, wherein the proximally oriented shoulder is distal to the distally oriented shoulder in the crimped state.

[0243] Example 4. The prosthetic valve of any example herein, particularly of any one of examples 1 to 3, wherein the proximally oriented shoulder is parallel to the distally oriented shoulder in the crimped state.

[0244] Example 5. The prosthetic valve of any example herein, particularly of any one of examples 1 to 4, wherein a minimal gap defined, in the crimped state, between adjacent angled struts of the second rung, is equal to or greater than the minimal gap defined between the proximally oriented shoulder and the distally oriented shoulder of adjacent axial frame members.

[0245] Example 6. The prosthetic valve of any example herein, particularly of any one of examples 1 to 5, wherein a minimal gap defined, in the crimped state, between adjacent angled struts of the second rung, is greater than the leaflet thickness.

[0246] Example 7. The prosthetic valve of any example herein, particularly of any one of examples 1 to 6, wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support members.

[0247] Example 8. The prosthetic valve of any example herein, particularly of any one of examples 1 to 7, wherein the commissure support member comprises a window opening.

[0248] Example 9. The prosthetic valve of any example herein, particularly of any one of examples 1 to 8, wherein at least some of the axial frame members further comprise an aperture formed in inflow end portion thereof.

[0249] Example 10. The prosthetic valve of any example herein, particularly of any one of examples 1 to 9, wherein pairs of adjacent angled struts of the same rung are configured to assume an outwardly bent configuration in the crimped state.

[0250] Example 11. The prosthetic valve of any example herein, particularly of any one of examples 1 to 9, wherein pairs of adjacent angled struts of the same rung are configured to extend parallel to each other in the crimped state. [0251] Example 12. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, wherein the frame comprises a plurality of intersecting struts arranged between an inflow end and an outflow end of the frame, the plurality of intersecting struts comprising: a plurality of angled struts arranged to form a plurality of circumferentially extending rungs of struts, the rungs comprising: an outflow rung comprising outflow struts, a second rung distal to the outflow rung, and one or more additional rungs of angled struts; a plurality of axial frame members extending between the outflow rung and the second rung, the axial frame members comprising: a plurality of axial struts and a plurality of commissure support members; and a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, wherein each leaflet has a leaflet thickness; wherein an inflow edge portion of at least one of the plurality of axial struts defines a proximally oriented shoulder, and an inflow edge portion of at least one of the plurality of commissure support members defines a distally oriented shoulder, such that a minimal gap defined, in the crimped state, between the inflow edge portions of adjacent axial frame members, is greater than the leaflet thickness.

[0252] Example 13. The prosthetic valve of any example herein, particularly of example 12, wherein the gap defined in the crimped state between the inflow edge portions of adjacent axial frame members is uniform along the lengths of the inflow edge portions.

[0253] Example 14. The prosthetic valve of any example herein, particularly of example 12 or 13, wherein the proximally oriented shoulder is distal to the distally oriented shoulder in the crimped state.

[0254] Example 15. The prosthetic valve of any example herein, particularly of any one of examples 12 to 14, wherein the inflow edge portions of adjacent axial frame members are parallel to each other in the crimped state.

[0255] Example 16. The prosthetic valve of any example herein, particularly of any one of examples 12 to 15, wherein a minimal gap defined, in the crimped state, between adjacent angled struts of the second rung, is equal to or greater than the minimal gap defined between the inflow edge portions of adjacent axial frame members.

[0256] Example 17. The prosthetic valve of any example herein, particularly of any one of examples 12 to 16, wherein a minimal gap defined, in the crimped state, between adjacent angled struts of the second rung, is greater than the leaflet thickness.

[0257] Example 18. The prosthetic valve of any example herein, particularly of any one of examples 12 to 17, wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support members. [0258] Example 19. The prosthetic valve of any example herein, particularly of any one of examples 12 to 18, wherein the commissure support member comprises a window opening.

[0259] Example 20. The prosthetic valve of any example herein, particularly of any one of examples 12 to 19, wherein at least some of the axial frame members further comprise an aperture formed in inflow end portion thereof.

[0260] Example 21. The prosthetic valve of any example herein, particularly of any one of examples 12 to 20, wherein pairs of adjacent angled struts of the same rung are configured to assume an outwardly bent configuration in the crimped state.

[0261] Example 22. The prosthetic valve of any example herein, particularly of any one of examples 12 to 20, wherein pairs of adjacent angled struts of the same rung are configured to extend parallel to each other in the crimped state.

[0262] Example 23. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, wherein the frame comprises a plurality of intersecting struts arranged between an inflow end and an outflow end of the frame, the plurality of intersecting struts comprising: a plurality of angled struts arranged to form a plurality of circumferentially extending rungs of struts, the rungs comprising: an outflow rung comprising outflow struts, a second rung distal to the outflow rung, and an inflow rung comprising inflow struts; and a plurality of axial frame members extending between the outflow rung and the second rung; and wherein pairs of adjacent angled struts of the same rung are configured to assume an outwardly bent configuration in the crimped state.

[0263] Example 24. The prosthetic valve of any example herein, particularly of example 23, wherein each pair of adjacent angled struts of the second rung extend from a mutual horizontal strut.

[0264] Example 25. The prosthetic of any example herein, particularly of example 24, wherein the length of the horizontal strut is within a range of 0.3 mm - 0.4 mm.

[0265] Example 26. The prosthetic valve of any example herein, particularly of example 24, wherein the length of the horizontal strut is within a range of 0.32 mm - 0.36 mm.

[0266] Example 27. The prosthetic valve of any example herein, particularly of any one of examples 24 to 26, wherein a gap defined between ends of adjacent angled struts, opposite of the horizontal strut, is greater, in the crimped state, than the length of the horizontal strut.

[0267] Example 28. The prosthetic valve of any example herein, particularly of example of claim 27, wherein the gap defined in the crimped state between ends of adjacent angled struts, opposite of the horizontal strut, is within a range of 0.47 mm. - 0.57 mm. [0268] Example 29. The prosthetic valve of any example herein, particularly of example 27, wherein the gap defined in the crimped state between ends of adjacent angled struts, opposite of the horizontal strut, is within a range of 0.5 mm. - 0.54 mm.

[0269] Example 30. The prosthetic valve of any example herein, particularly of example 27, wherein the gap defined in the crimped state between ends of adjacent angled struts, opposite of the horizontal strut, is at least as great as 120% of the length of the horizontal strut.

[0270] Example 31. The prosthetic valve of any example herein, particularly of example 27, wherein the gap defined in the crimped state between ends of adjacent angled struts, opposite of the horizontal strut, is at least as great as 130% of the length of the horizontal strut.

[0271] Example 32. The prosthetic valve of any example herein, particularly of example 27, wherein the gap defined in the crimped state between ends of adjacent angled struts, opposite of the horizontal strut, is at least as great as 150% of the length of the horizontal strut.

[0272] Example 33. The prosthetic valve of any example herein, particularly of any one of examples 27 to 32, wherein a gap defined in the crimped state between inflow end portions of adjacent axial frame members is equal to or greater than the gap defined between ends of adjacent angled struts, opposite of the horizontal strut.

[0273] Example 34. The prosthetic valve of any example herein, particularly of any one of examples 23 to 33, further comprising a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.

[0274] Example 35. The prosthetic valve of claim 34, wherein the axial frame members comprise a plurality of axial struts and a plurality of commissure support members.

[0275] Example 36. The prosthetic valve of any example herein, particularly of example 35, wherein each commissure support member comprises a window opening.

[0276] Example 37. The prosthetic valve of any example herein, particularly of example 34 or 35, wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support members.

[0277] Example 38. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, wherein the frame comprises a plurality of intersecting struts arranged between an inflow end and an outflow end of the frame, the plurality of intersecting struts comprising: a plurality of angled struts arranged to form a plurality of circumferentially extending rungs of struts, the rungs comprising: an outflow rung comprising outflow struts, a second rung distal to the outflow rung, and an inflow rung comprising inflow struts; and a plurality of axial frame members extending between the outflow rung and the second rung; and wherein inner edges of adjacent angled struts extending from mutual apex regions of the frame are configured to contact each other in the crimped state, so as to maintain a gap between adjacent angled struts of at least one other rung of the frame.

[0278] Example 39. The prosthetic valve of any example herein, particularly of example 38, wherein the angled struts comprising the inner edges contacting each other in the crimped state are the outflow struts.

[0279] Example 40. The prosthetic valve of any example herein, particularly of example 39, wherein the angled struts of the at least one other rung between which the gap is maintained are angled struts of the second rung.

[0280] Example 41. The prosthetic valve of any example herein, particularly of example 39 or 40, wherein the inner edge of each outflow strut is laterally offset from the corresponding inner edge of the axial frame member extending therefrom.

[0281] Example 42. The prosthetic valve of any example herein, particularly of any one of examples 39 to 41, wherein a width of each outflow strut is greater than a width of any angled strut of the second rung.

[0282] Example 43. The prosthetic valve of any example herein, particularly of any one of examples 39 to 42, wherein outer edges of neighboring outflow struts are spaced from each other, in the crimped state, along at least part of the length of the outflow struts.

[0283] Example 44. The prosthetic valve of any example herein, particularly of any one of examples 39 to 43, wherein the diameter of the frame at the outflow end is greater than its diameter along the second rung.

[0284] Example 45. The prosthetic valve of any example herein, particularly of any one of examples 39 to 44, wherein the inner edges of adjacent outflow struts are further configured to maintain, in the crimped state, a gap between adjacent axial frame members.

[0285] Example 46. The prosthetic valve of any example herein, particularly of example 45, wherein the gap defined between adjacent axial frame members, in the crimped state, is equal to or greater than the gap between adjacent angled stmts of the second rung.

[0286] Example 47. The prosthetic valve of any example herein, particularly of example 38, wherein the angled stmts comprising the inner edges contacting each other in the crimped state are the inflow stmts.

[0287] Example 48. The prosthetic valve of any example herein, particularly of example 47, wherein the angled stmts of the at least one other mng between which the gap is maintained are angled stmts extending proximally from the inflow mng. [0288] Example 49. The prosthetic valve of any example herein, particularly of any one of examples 48, wherein the inner edge of each inflow strut is laterally offset from the corresponding inner edge of the angled strut extending proximally therefrom.

[0289] Example 50. The prosthetic valve of any example herein, particularly of example 48 or 49, wherein a width of each inflow strut is greater than a width of the angled strut extending proximally therefrom.

[0290] Example 51. The prosthetic valve of any example herein, particularly of any one of examples 47 to 50, wherein outer edges of neighboring inflow struts are spaced from each other, in the crimped state, along at least part of the length of the inflow struts.

[0291] Example 52. The prosthetic valve of any example herein, particularly of any one of examples 47 to 51, wherein the diameter of the frame at the inflow end is greater than its diameter along the second rung.

[0292] Example 53. The prosthetic valve of any example herein, particularly of any one of examples 38 to 52, further comprising a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.

[0293] Example 54. The prosthetic valve of any example herein, particularly of example 53, wherein the axial frame members comprise a plurality of axial struts and a plurality of commissure support members.

[0294] Example 55. The prosthetic valve of any example herein, particularly of example 54, wherein each commissure support member comprises a window opening.

[0295] Example 56. The prosthetic valve of any example herein, particularly of example 54 or 55, wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support members.

[0296] Example 57. The prosthetic valve of any example herein, particularly of any one of examples 53 to 56, further comprising an inner skirt disposed inside of and coupled to the frame.

[0297] Example 58. The prosthetic valve of any example herein, particularly of example 57, wherein the leaflets are coupled, along cusp edge portions thereof, to the inner skirt.

[0298] Example 59. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, wherein the frame comprises a plurality of intersecting struts arranged between an inflow end and an outflow end of the frame, the plurality of intersecting struts comprising: a plurality of angled struts arranged to form a plurality of circumferentially extending rungs of struts, the rungs comprising: an outflow rung comprising outflow struts, a second rung distal to the outflow rung, and an inflow rung comprising inflow struts; and a plurality of axial frame members extending between the outflow rung and the second rung; and a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, wherein each leaflet has a leaflet thickness; wherein one or more angled struts of a pair of adjacent angled struts extending from mutual apex regions of the frame further comprises a lateral bump configured to contact the adjacent angled strut in the crimped state, in a manner that maintains a gap between adjacent angled struts of at least one other rung of the frame.

[0299] Example 60. The prosthetic valve of claim 59, wherein the lateral bumps extend from inner edges of the adjacent angled struts.

[0300] Example 61. The prosthetic valve of any example herein, particularly of example 60, wherein outer edges of neighboring struts that include the lateral bumps extending from their inner edges, are devoid of lateral bumps.

[0301] Example 62. The prosthetic valve of any example herein, particularly of example 61, wherein the outer edges of neighboring struts that include the lateral bumps extending from their inner edges, are spaced from each other, in the crimped state, along at least a portion of the length of the angled struts.

[0302] Example 63. The prosthetic valve of any example herein, particularly of example 60, wherein at least some of the angled struts that include lateral bumps extending from their inner edges, further comprise lateral bumps extending from their outer edges.

[0303] Example 64. The prosthetic valve of any example herein, particularly of example 63, wherein the lateral bumps extending from the outer edges of neighboring angled struts are configured to contact each other in the crimped state.

[0304] Example 65. The prosthetic valve of any example herein, particularly of any one of examples 59 to 64, wherein one lateral bump extending from one of the angled struts of the pair of angled struts defines a proximally oriented edge portion.

[0305] Example 66. The prosthetic valve of any example herein, particularly of example 65, wherein the lateral bump extending from one of the angled struts of the pair of angled struts is configured to engage with a complementary support member of the adjacent angled strut of the pair of angled struts, in the crimped state.

[0306] Example 67. The prosthetic valve of any example herein, particularly of example 66, wherein the complementary support member comprises a distally oriented edge portion configured to contact the proximally oriented edge portion in the crimped state. [0307] Example 68. The prosthetic valve of any example herein, particularly of example 67, wherein the proximally oriented edge portion and the distally oriented edge portion have complementary shapes.

[0308] Example 69. The prosthetic valve of any example herein, particularly of example 67 or 68, wherein the proximally oriented edge portion and the distally oriented edge portion are curved.

[0309] Example 70. The prosthetic valve of any example herein, particularly of any one of examples 59 to 69, wherein the angled struts comprising the lateral bumps are the outflow struts.

[0310] Example 71. The prosthetic valve of any example herein, particularly of example 70, wherein the angled struts of the at least one other rung between which the gap is maintained are angled struts of the second rung.

[0311] Example 72. The prosthetic valve of any example herein, particularly of example 70 or 71, wherein the lateral bumps are further configured to maintain, in the crimped state, a gap between adjacent axial frame members.

[0312] Example 73. The prosthetic valve of any example herein, particularly of example 72, wherein the gap defined between adjacent axial frame members, in the crimped state, is equal to or greater than the gap between adjacent angled struts of the second rung.

[0313] Example 74. The prosthetic valve of any example herein, particularly of any one of examples 59 to 69, wherein the angled struts comprising the inner edges contacting each other in the crimped state are the inflow struts.

[0314] Example 75. The prosthetic valve of any example herein, particularly of example 74, wherein the angled struts of the at least one other rung between which the gap is maintained are angled struts extending proximally from the inflow rung.

[0315] Example 76. The prosthetic valve of any example herein, particularly of any one of examples 59 to 75, further comprising a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.

[0316] Example 77. The prosthetic valve of any example herein, particularly of example 76, wherein the axial frame members comprise a plurality of axial struts and a plurality of commissure support members.

[0317] Example 78. The prosthetic valve of any example herein, particularly of example 77, wherein each commissure support member comprises a window opening. [0318] Example 79. The prosthetic valve of any example herein, particularly of example 77 or 78, wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support members.

[0319] Example 80. The prosthetic valve of any example herein, particularly of any one of examples 76 to 79, further comprising an inner skirt disposed inside of and coupled to the frame.

[0320] Example 81. The prosthetic valve of any example herein, particularly of example 80, wherein the leaflets are coupled, along cusp edge portions thereof, to the inner skirt.

[0321] Example 82. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, wherein the frame comprises a plurality of intersecting struts arranged between an inflow end and an outflow end of the frame, the plurality of intersecting struts comprising: a plurality of angled struts arranged to form a plurality of circumferentially extending rungs of struts, the rungs comprising: an outflow rung comprising outflow struts, a second rung distal to the outflow rung, and one or more additional rungs of angled struts; and a plurality of axial frame members extending between the outflow rung and the second rung, the axial frame members comprising: a plurality of axial struts and a plurality of commissure support members; and a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, wherein each leaflet has a leaflet thickness; wherein one or more of the axial frame members further comprises at least one lateral bump configured to contact an adjacent axial frame member in the crimped state, in a manner that maintains a gap between adjacent angled struts of the second rung.

[0322] Example 83. The prosthetic valve of any example herein, particularly of example 82, wherein each axial frame member that comprises the lateral bump extending from one side thereof, further comprises a lateral bump extending from an opposite side thereof.

[0323] Example 84. The prosthetic valve of any example herein, particularly of example 82 or 83, wherein the lateral bump comprises a proximally oriented edge portion.

[0324] Example 85. The prosthetic valve of any example herein, particularly of example 84, wherein the lateral bumps extend from outflow end portions of the corresponding axial frame members.

[0325] Example 86. The prosthetic valve of any example herein, particularly of example 84 or 85, wherein the axial frame member adjacent to the axial frame member that includes the lateral bump, is devoid of a lateral bump extending from a side facing the lateral bump. [0326] Example 87. The prosthetic valve of any example herein, particularly of any one of examples 84 to 86, wherein the proximally oriented edge portion is configured to engage, in the crimped state, a distally-oriented shoulder defined at the transition between outflow struts and the outflow end portion of the adjacent axial frame member.

[0327] Example 88. The prosthetic valve of any example herein, particularly of example 84, wherein the lateral bumps extend from intermediate portions of the corresponding axial frame members.

[0328] Example 89. The prosthetic valve of any example herein, particularly of example 84 or 88, wherein the lateral bump extending from one of the axial frame members is configured to engage with a complementary support member of the adjacent axial frame member, in the crimped state.

[0329] Example 90. The prosthetic valve of any example herein, particularly of example 89, wherein the complementary support member comprises a distally oriented edge portion configured to contact the proximally oriented edge portion in the crimped state.

[0330] Example 91. The prosthetic valve of any example herein, particularly of example 90, wherein the proximally oriented edge portion and the distally oriented edge portion have complementary shapes.

[0331] Example 92. The prosthetic valve of any example herein, particularly of example 90 or 91, wherein the proximally oriented edge portion and the distally oriented edge portion are curved.

[0332] Example 93. The prosthetic valve of any example herein, particularly of any one of examples 82 to 92, further comprising a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve.

[0333] Example 94. The prosthetic valve of any example herein, particularly of example 93, wherein the axial frame members comprise a plurality of axial struts and a plurality of commissure support members.

[0334] Example 95. The prosthetic valve of any example herein, particularly of example 94, wherein each commissure support member comprises a window opening.

[0335] Example 96. The prosthetic valve of any example herein, particularly of example 94 or 95, wherein each two adjacent leaflets are coupled to each other at commissures attached to the commissure support members.

[0336] It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate examples, may also be provided in combination in a single example. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single example, may also be provided separately or in any suitable sub-combination or as suitable in any other described example of the disclosure. No feature described in the context of an example is to be considered an essential feature of that example, unless explicitly specified as such.

[0337] 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

1. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, wherein the frame comprises a plurality of intersecting struts arranged between an inflow end and an outflow end of the frame, the plurality of intersecting struts comprising: a plurality of angled struts arranged to form a plurality of circumferentially extending rungs of struts, the rungs comprising: an outflow rung comprising outflow struts, a second rung distal to the outflow rung, and one or more additional rungs of angled struts; and a plurality of axial frame members extending between the outflow rung and the second rung, the axial frame members comprising: a plurality of axial struts and a plurality of commissure support members; and a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, wherein each leaflet has a leaflet thickness; wherein an inflow edge portion of at least one of the plurality of axial struts defines a proximally oriented shoulder, and an inflow edge portion of at least one of the plurality of commissure support members defines a distally oriented shoulder, such that a minimal gap defined, in the crimped state, between the proximally oriented shoulder and the distally oriented shoulder of adjacent axial frame members, is greater than the leaflet thickness.

2. The prosthetic valve of claim 1 , wherein the gap defined in the crimped state between the proximally oriented shoulder and the distally oriented shoulder of adjacent axial frame members, is uniform along the lengths of the proximally oriented shoulder and the distally oriented shoulder.

3. The prosthetic valve of claim 1 or 2, wherein the proximally oriented shoulder is distal to the distally oriented shoulder in the crimped state.

4. The prosthetic valve of any one of claims 1 to 3, wherein the proximally oriented shoulder is parallel to the distally oriented shoulder in the crimped state.

5. The prosthetic valve of any one of claims 1 to 4, wherein a minimal gap defined, in the crimped state, between adjacent angled struts of the second rung, is equal to or greater than the minimal gap defined between the proximally oriented shoulder and the distally oriented shoulder of adjacent axial frame members.

6. The prosthetic valve of any one of claims 1 to 5, wherein a minimal gap defined, in the crimped state, between adjacent angled struts of the second rung, is greater than the leaflet thickness.

7. The prosthetic valve of any one of claims 1 to 6, wherein pairs of adjacent angled struts of the same rung are configured to assume an outwardly bent configuration in the crimped state.

8. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, wherein the frame comprises a plurality of intersecting struts arranged between an inflow end and an outflow end of the frame, the plurality of intersecting struts comprising: a plurality of angled struts arranged to form a plurality of circumferentially extending rungs of struts, the rungs comprising: an outflow rung comprising outflow struts, a second rung distal to the outflow rung, and an inflow rung comprising inflow struts; and a plurality of axial frame members extending between the outflow rung and the second rung; and wherein pairs of adjacent angled struts of the same rung are configured to assume an outwardly bent configuration in the crimped state.

9. The prosthetic valve of claim 8, wherein each pair of adjacent angled struts of the second rung extend from a mutual horizontal strut.

10. The prosthetic valve of claim 9, wherein the length of the horizontal strut is within a range of 0.3 mm - 0.4 mm.

11. The prosthetic valve of any one of claims 9 to 10, wherein a gap defined between ends of adjacent angled struts, opposite of the horizontal strut, is greater, in the crimped state, than the length of the horizontal strut.

12. The prosthetic valve of claim 11, wherein the gap defined in the crimped state between ends of adjacent angled struts, opposite of the horizontal strut, is within a range of 0.47 mm. - 0.57 mm.

13. The prosthetic valve of claim 11, wherein the gap defined in the crimped state between ends of adjacent angled struts, opposite of the horizontal strut, is at least as great as 120% of the length of the horizontal strut.

14. The prosthetic valve of any one of claims 11 to 13, wherein a gap defined in the crimped state between inflow end portions of adjacent axial frame members is equal to or greater than the gap defined between ends of adjacent angled struts, opposite of the horizontal strut.

15. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, wherein the frame comprises a plurality of intersecting struts arranged between an inflow end and an outflow end of the frame, the plurality of intersecting struts comprising: a plurality of angled struts arranged to form a plurality of circumferentially extending rungs of struts, the rungs comprising: an outflow rung comprising outflow struts, a second rung distal to the outflow rung, and an inflow rung comprising inflow struts; and a plurality of axial frame members extending between the outflow rung and the second rung; and a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve, wherein each leaflet has a leaflet thickness; wherein one or more angled struts of a pair of adjacent angled struts extending from mutual apex regions of the frame further comprises a lateral bump configured to contact the adjacent angled strut in the crimped state, in a manner that maintains a gap between adjacent angled struts of at least one other rung of the frame.

16. The prosthetic valve of claim 15, wherein the lateral bumps extend from inner edges of the adjacent angled struts.

17. The prosthetic valve of claim 16, wherein at least some of the angled struts that include lateral bumps extending from their inner edges, further comprise lateral bumps extending from their outer edges.

18. The prosthetic valve of any one of claims 15 to 17, wherein one lateral bump extending from one of the angled struts of the pair of angled struts defines a proximally oriented edge portion, and wherein the lateral bump extending from one of the angled struts of the pair of angled struts is configured to engage with a complementary support member of the adjacent angled strut of the pair of angled struts, in the crimped state.

19. The prosthetic valve of claim 18, wherein the complementary support member comprises a distally oriented edge portion configured to contact the proximally oriented edge portion in the crimped state.

20. The prosthetic valve of claim 19, wherein the proximally oriented edge portion and the distally oriented edge portion have complementary shapes.

21. The prosthetic valve of any one of claims 15 to 20, wherein the angled struts comprising the lateral bumps are the outflow struts.

22. The prosthetic valve of claim 21, wherein the lateral bumps are further configured to maintain, in the crimped state, a gap between adjacent axial frame members.