Prosthetic valves and unitary valvular structures thereof

Abstract

The present disclosure relates to prosthetic valves and valvular structures thereof. In an example, a prosthetic valve can include a frame movable between a radially compressed configuration and a radially expanded configuration, and a valvular structure coupled to the frame. The valvular structure is a one-piece material that includes a plurality of integrally formed leaflets configured to regulate flow through the prosthetic valve, and at least one integral commissure fold continuously extending between two adjacent leaflets. The integral commissure fold is defined proximal to an intermediate slit of the valvular structure, and extends radially outwards through a window opening of the frame, forming a first commissure coupled to the frame.

Description

PROSTHETIC VALVES AND UNITARY VALVULAR STRUCTURES THEREOFCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 635,285, filed April 17, 2024, which is incorporated by reference herein.FIELD

[0002] The present disclosure relates to implantable, radially expandable prosthetic devices, such as prosthetic valves, and in particular, to prosthetic valves that include one-piece valvular structures.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] The prosthetic heart valve can include valvular structure (having two or more leaflets) for regulating blood flow in a single direction. The leaflets can form commissures between adjacent ones of the leaflets. The commissures can be attached to a frame of the prosthetic heart valve.SUMMARY

[0006] The present disclosure is directed towards prosthetic valves comprising unitary valvular structures that define integral leaflets attached to frames of the valves via commissures extending through window openings or cells of the frame.

[0007] In one of its basic configurations, a prosthetic valve comprises a valvular structure comprising a plurality of integrally formed leaflets configured to regulate flow through the prosthetic valve, and at least one integral commissure fold continuously extending between two adjacent leaflets and forming a first commissure extending through a first window opening of a frame of the prosthetic valve. 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 frame is movable between a radially compressed configuration and a radially expanded configuration.

[0009] In some examples, the valvular structure is coupled to the frame.

[0010] In some examples, the first commissure can optionally be coupled to the frame.

[0011] In some examples, the integral commissure fold can optionally be defined proximal to an intermediate slit of the valvular structure.

[0012] In some examples, the integral commissure fold can optionally extend radially outwards through the first window.

[0013] In some examples, the valvular structure can optionally be a one-piece material.

[0014] In some examples, the first commissure optionally comprises a first wedge member optionally extending through a channel of the integral commissure fold.

[0015] In some examples, a total width of the first commissure can be greater than a width of the first window opening.

[0016] In some examples, the valvular structure can optionally be formed from a patch comprising two opposing side edges attached to each other to optionally form a cylindrical configuration of the valvular structure.

[0017] In some examples, the valvular structure optionally comprises two tabs optionally extending from the opposing side edges.

[0018] In some examples, the tabs optionally extend radially outwards through a second window opening of the frame, forming a second commissure coupled to the frame.

[0019] In some examples, the tabs can optionally be wrapped around a second wedge member of the second commissure.

[0020] In some examples, a total width of the second commissure can be greater than a width of the second window opening.

[0021] In some examples, the frame optionally comprises an outflow rung of angled struts, a first subsequent rung of angled struts, and a plurality of axial frame members optionally extending between the outflow rung and the first subsequent rung.

[0022] In some examples, the plurality of axial frame members optionally comprises a plurality of axial post struts and a plurality of axial support members.

[0023] In some examples, the first commissure can optionally be coupled to the corresponding first commissure post.

[0024] In some examples, the plurality of axial frame members optionally comprises a plurality of axial struts and a plurality of commissure support members.

[0025] In some examples, at least one of the commissure support members can be a first commissure support member optionally defining the first window between sidewalls of the first commissure support member.

[0026] In some examples, the first commissure can optionally be coupled to the corresponding first commissure support member.

[0027] In some examples, the valvular structure optionally comprises a pocket distal to the intermediate slit, the pocket optionally extending radially outwards through an axially-adjacent cell of the frame, which is distal to the first commissure support member.

[0028] In some examples, the first wedge member optionally extends from the integral commissure fold, across a junction optionally connecting the first commissure support member with the axially-adjacent cell, into the pocket.

[0029] In some examples, the first commissure support member optionally comprises a crossbar extending between the sidewalls, wherein the first window opening can be a first upper window opening optionally extending proximally from the crossbar, and wherein the first commissure support member optionally comprises a first lower window opening optionally extending distally from the crossbar.

[0030] In some examples, the valvular structure optionally comprises a pocket distal to the intermediate slit, the pocket optionally extending radially outwards through the first lower window opening.

[0031] In some examples, the first wedge member optionally extends from the integral commissure fold, across the crossbar, into the pocket.

[0032] In some examples, the integral commissure fold extending through the first upper window opening can be an upper integral commissure fold, wherein the valvular structure optionally comprises a lower integral commissure fold optionally extending radially outwards through the first lower window opening.

[0033] In some examples, the intermediate slit at which the upper integral commissure fold terminates can be an upper intermediate slit, wherein the lower integral commissure fold optionally axially extends between the upper intermediate slit and a lower intermediate slit of the valvular structure.

[0034] In some examples, the first wedge member optionally extends from the upper integral commissure fold, across the crossbar, into through a channel of the lower integral commissure fold.

[0035] In one of its basic configurations, a prosthetic valve comprises a valvular structure comprising a plurality of integrally formed leaflets configured to regulate flow through the prosthetic valve, and at least one integral commissure fold continuously extending between two adjacent leaflets and forming a first commissure extending through an outflow cell of a frame of the prosthetic valve. 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.

[0036] In some examples, the frame is movable between a radially compressed configuration and a radially expanded configuration.

[0037] In some examples, the valvular structure is coupled to the frame.

[0038] In some examples, the first commissure can optionally be coupled to the frame.

[0039] In some examples, the integral commissure fold can optionally be defined proximal to an intermediate slit of the valvular structure.

[0040] In some examples, the frame can comprise an outflow cell row, a first subsequent cell row, and a second subsequent cell row.

[0041] In some examples, the integral commissure fold can optionally extend radially outwards through the outflow cell.

[0042] In some examples, the valvular structure can optionally be a one-piece material.

[0043] In some examples, the commissure optionally comprises a wedge member optionally extending through a channel of the integral commissure fold.

[0044] In some examples, the valvular structure optionally comprises a pocket distal to the intermediate slit, the pocket optionally extending radially outwards through an axially-adjacent cell of the second subsequent cell row.

[0045] In some examples, the wedge member optionally extends from the integral commissure fold, across a junction optionally connecting the outflow cell with the axially-adjacent cell, into the pocket.

[0046] In some examples, the integral commissure fold extending through the outflow cell can be an upper integral commissure fold, wherein the valvular structure optionally comprises a lower integral commissure fold optionally extending radially outwards through an axially- adjacent cell of the second subsequent cell row.

[0047] In some examples, the intermediate slit at which the upper integral commissure fold optionally terminates can be an upper intermediate slit, wherein the lower integral commissure fold axially optionally extends between the upper intermediate slit and a lower intermediate slit of the valvular structure.

[0048] In some examples, the wedge member optionally extends from the upper integral commissure fold, across a junction optionally connecting the outflow cell with the axially- adjacent cell, into through a channel of the lower integral commissure fold.

[0049] 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

[0050] 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:

[0051] Fig. 1A is a perspective side view of an exemplary prosthetic valve.

[0052] Fig. IB is a perspective view of an annular frame of the prosthetic valve of Fig. 1A.

[0053] Fig. 1C is a flattened view of the frame of Fig. IB.

[0054] Fig. 2A shows a flattened view of one-piece valvular structure.

[0055] Fig. 2B shows a flattened view of the valvular structure of Fig. 2A with slits.

[0056] Fig. 2C shows the valvular structure of Fig. 2B in a 3D-shaped configuration.

[0057] Fig. 2D shows the valvular structure of Fig. 2C rolled into a cylindrical configuration.

[0058] Fig. 2E shows a final cylindrical configuration of the valvular structure of Fig. 2D.

[0059] Fig. 3A shows an exemplary commissure comprising an integral commissure fold of the valvular structure.

[0060] Fig. 3B shows an exemplary commissure comprising tabs of the valvular structure.

[0061] Fig. 4A is a side view of an exemplary prosthetic valve.

[0062] Fig. 4B is a perspective view of an annular frame of the prosthetic valve of Fig. 4A.

[0063] Fig. 5 shows an exemplary commissure of the prosthetic valve of Fig. 4A.

[0064] Fig. 6 is a perspective view of an annular frame comprising H-shaped commissure support members defining open window portions.

[0065] Fig. 7A shows an exemplary commissure comprising an integral commissure fold coupled to the frame of Fig. 6.

[0066] Fig. 7B shows an exemplary commissure comprising tabs coupled to the frame of Fig.6.

[0067] Fig. 8 is a perspective view of an annular frame comprising H-shaped commissure support members defining closed window portions.

[0068] Fig. 9 shows a flattened view of an exemplary valvular structure comprising upper and lower slits.

[0069] Fig. 10A shows an exemplary commissure comprising integral commissure folds of the valvular structure of Fig. 9 coupled to the frame of Fig. 8.

[0070] Fig. 10B shows an exemplary commissure comprising tabs of the valvular structure of Fig. 9 coupled to the frame of Fig. 8.

[0071] Fig. 11 is a side view of an exemplary prosthetic valve.

[0072] Fig. 12 is a perspective view of a portion of the prosthetic valve of Fig. 11.DETAILED DESCRIPTION

[0073] 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 disclosureis 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.

[0074] 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.

[0075] 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.

[0076] 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”.

[0077] 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 withrespect 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.

[0078] 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.

[0079] The term “proximal”, as used herein, generally refers to a position, direction, or portion of any device or a component of a device, which is closer to a user of a delivery apparatus that can be used to implant the device in the patient and farther away from the implantation site. 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 device. The term “distal”, as used herein, generally refers to a position, direction, or portion of any device or a component of a device, which is further away from the user and closer to the implantation site. 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.

[0080] 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.

[0081] Figs. 1 A and IB show perspective views of an example of a prosthetic valve 100, with and without soft components (such as skirts and a valvular structure), respectively. The term "prosthetic valve", as used herein, refers to any type of a prosthetic valve deliverable to a patient's target site over a catheter, which is radially expandable and compressible between a radially compressed, or crimped, state, and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus (not shown) in the radially compressed state during delivery, and then expanded to the radially expanded stateonce the prosthetic valve reaches the implantation site. The expanded state may include a range of diameters to which the valve may expand, between the compressed state and a maximal diameter reached at a fully expanded state. Thus, a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state. A prosthetic valve 100 (described herein with respect to Figs. 1A-3B, for example), 200 (described herein with respect to Figs. 4A-10B, for example), or 300 (described herein with respect to Figs. 11-12, for example) of the current disclosure may include any prosthetic valve configured to he mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve.

[0082] It is to be understood that the 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. 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.

[0083] The term "plurality", as used herein, means more than one.

[0084] The prosthetic valve 100 comprises an inflow end 106 and an outflow end 104. In some instances, the inflow end 106 is the distal end of the prosthetic valve 100, and the outflow end 104 is the proximal end of the prosthetic valve 100. Alternatively, depending for example on the delivery approach of the valve, the inflow end can be the proximal end of the prosthetic valve, and the outflow end can be the distal end of the prosthetic valve.

[0085] 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.

[0086] The term "inflow", as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve.

[0087] 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.

[0088] The terms “longitudinal” and “axial”, as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0089] The valve 100 comprises an annular frame 102 movable between a radially compressed state and a radially expanded state, and a valvular structure 50 mounted within the frame 102. Fig. 1C shows the frame 102 of Fig. IB in a flat configuration for purposes of illustration. The frame 102 can be made of various suitable materials, including plastically-deformable materials such as, but not limited to, stainless steel, a nickel-based alloy (e.g., a cobaltchromium or a nickel-cobalt-chromium alloy such as MP35N alloy), polymers, or combinations thereof. When constructed of a plastically-deformable materials, the frame 102 can be crimped to a radially compressed state on a balloon catheter (not shown), and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. Alternatively or additionally, the frame 102 can be made of shape-memory materials such as, but not limited to, nickel-titanium alloy (e.g., Nitinol).

[0090] In the example illustrated in Figs. 1A-1B, the frame 102 is an annular, stent-like structure comprising a plurality of intersecting struts 110. In this application, the term "strut" 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 110 may be any elongated member or portion of the frame 102. The frame 102 can include a plurality of strut rungs 114 that can collectively define a plurality of cells 128 arranged in several cell rows 130. The frame 102 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 106 to the outflow end 104 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.

[0091] Two or more struts 110 can intersect at junctions 138, which can be equally or unequally spaced apart from each other. The struts 110 may be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 102 canbe 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.

[0092] Figs. 1A-1C show an exemplary prosthetic valve 100 that can be representative of, but is not limited to, a balloon expandable prosthetic valve. In some examples, the struts 110 comprise angled struts 112 and axial frame members 116. The term "axial frame member" refers to a strut or a component of the frame 102 that generally extends in an axial direction, while the term "angled strut" generally refers to a strut that can extend at an angle relative to an axial line intersecting therewith along a plane defined by the frame 102. It is to be understood that the term "angled strut" encompasses both linear angled struts and curved struts.

[0093] The frame 102 can further comprise a plurality of outflow apices 132 at the outflow end 104 of the frame, and a plurality of inflow apices 134 at the inflow end 106 of the frame. A plurality of intermediate junctions 138 are disposed between the inflow end 106 and outflow end 104.

[0094] The frame 102 of a prosthetic valve 100 comprises an outflow rung 1140 of outflow angled struts 1120 at the outflow end 104 of the frame, and a plurality of subsequent rungs 114S distal to the outflow rung 1140, each comprising a plurality of subsequent angled struts 112S. The distal-most rung at the inflow end 106 of the frame can be also referred to as an inflow rung 1141 comprising a plurality of inflow angled struts 1121.

[0095] The frame 102 further comprises an outflow cell row 1300 of outflow cells 1280 at the outflow end 104 of the frame, and a plurality of subsequent cell rows 130S distal to the outflow cell row 1300, each comprising a plurality of subsequent cells 128S. The distal-most cell row at the inflow end 106 of the frame can be also referred to as an inflow cell row 1301 comprising a plurality of inflow cells 1281.

[0096] In the example illustrated in Figs. 1A-1C, the frame 102 of the prosthetic valve 100 is shown to comprise five subsequent rungs 114 distal to the outflow rung 1140, defining four subsequent cells rows 130 distal to the outflow cell row 1300. Namely, the frame 102 is shown to include a first subsequent rung 114S1 distal to the outflow rung 1140 and comprising subsequent angled struts 112S1, a second subsequent rung 114S2 distal to the first subsequent rung 114S1 and comprising subsequent angled struts 112S2, a third subsequent rung 114S3 distal to the second subsequent rung 114S2 and comprising subsequent angled struts 112S3, a fourth subsequent rung 114S4 distal to the third subsequent rung 114S3 and comprising subsequent angled struts 112S4, and an inflow rung 1141 distal to the fourth subsequent rung 114S4 and comprising inflow angled struts 1121.

[0097] Similarly, the frame 102 is shown to include a first subsequent cell row 130S1 distal to the outflow cell row 1300 and comprising subsequent cells 128S1, a second subsequent cell row 130S2 distal to the first subsequent cell row 130S1 and comprising subsequent cells 128S2, a third subsequent cell row 13OS3 distal to the second subsequent cell row 130S2 and comprising subsequent cells 128S3, and an inflow cell row 1301 distal to the third subsequent cell row 130S3 and comprising inflow cells 1281.

[0098] A frame 102 of a prosthetic valve 100 can include a plurality of axial frame members 1 16 vertically extending between the outflow rung 1 140 of angled struts 1120, and the first or proximal-most subsequent rung 114S1 of angled struts 112S1.

[0099] The upper end portions of the outflow angled struts 1120 of the outflow rung 1140 are forming the outflow apices 132 at or proximate to the outflow end 104, and end portions of the inflow angled struts 1121 of the inflow rung 1141 are forming the inflow apices 134 at the inflow end 106. The outflow angled struts 1120 of the outflow rung 1140 are further connected to axial frame members 116 at lower junctions 138 which are distal to the outflow apices 132, such that the outflow angled struts 1120 circumferentially extend in a zig-zagged formation between the outflow apices 132 and the lower junctions 138 of the outflow rung 1140.

[0100] The struts of each of the subsequent rungs 114S, including the inflow rung 1141, can also extend circumferentially in a zig-zagged formation between upper and lower junctions 138 thereof. In some examples, the first subsequent rung 114S1 can further define a plurality of free apices 136 which are circumferentially aligned with the outflow apices 132. Free apices 136 are defined as apices of the first subsequent rung 114S 1 which are not attached to any other struts 110 other than the first angled struts 112S1 of the first subsequent rung 114S1. The remainder of the upper junctions 138 of the first subsequent rung 114S 1, which are not free apices 136, can be further connected to axial frame members 116 extending proximally therefrom.

[0101] The valvular structure 50 can include a plurality of leaflets 52 (e.g., three leaflets), positioned at least partially within the frame 102, and configured to regulate flow of blood through the prosthetic valve 100 from the inflow end 106 to the outflow end 104. While three leaflets 52 arranged to collapse in a tricuspid arrangement, are shown in the example illustrated in Fig. 1 A, it will be clear that a prosthetic valve 100 can include any other number of leaflets 52. Adjacent leaflets 52 can be arranged together to form commissures 80 that are coupled (directly or indirectly) to respective portions of the frame 102, thereby securing at least a portion of the valvular structure 50 to the frame 102.

[0102] The prosthetic valve 100 can further comprise at least one skirt or sealing member. In some examples, a prosthetic valve can include an inner skirt 146 secured to an inner surface 107 of the frame 102, and configured to function, for example, as a sealing member to prevent or decrease perivalvular leakage. In some examples, an inner skirt can be provided as an integrally formed region of the valvular structure 50. In some examples, an inner skirt can be provided as a separate component that can further function as an anchoring region for the leaflets 52 to the frame 102, and / or function to protect the leaflets 52 against damage which may be caused by contact with the frame 102, for example during valve crimping or during working cycles of the prosthetic valve 100.

[0103] In some examples, a prosthetic valve 100 can include an outer skirt 148 mounted on an outer surface 108 of the frame 102, and configure to function, for example, as a sealing member retained between the frame 102 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 100.

[0104] Any of an inner skirt 146 and / or outer skirt 148 can be made of various suitable biocompatible materials, such as, but not limited to, various synthetic materials (e.g., PET) or natural tissue (e.g. pericardial tissue). In some examples, an inner skirt 146 comprises a single sheet of material that extends continuously around the inner surface 107 of the frame 102. In some examples, the outer skirt 148 comprises a single sheet of material that extends continuously around the outer surface 108 of the frame 102.

[0105] In some examples, frame 102 can further include a plurality of commissure posts 122 coupled to the outflow rung 1140 and extending axially therefrom. In the example illustrated in Figs. 1A-1C, the frame 102 is shown to include commissure posts 122 extending proximally from the outflow rung 1140. Each commissure post 122 is configured to support a commissure 80 coupled thereto, such as by including an attachment feature that can facilitate coupling of the commissure 80 to the frame 102. In some examples, the attachment feature can include window opening 124 defined between two axially-extending sidewalls 126. The number of commissure posts 122 can match the number of leaflets 52. In some examples, the frame 102 can include three commissure posts 122.

[0106] In some examples, the commissure posts 122 can extend from lower junctions 138 of the outflow rung 1140 beyond the outflow apices 132 in the proximal direction, terminating proximal to the outflow apices 132, in the expanded state of the frame 102.

[0107] The axial frame members 116 can extend between upper junctions 138 of the first subsequent rung 114S1 and lower junctions 138 of the outflow rung 1140. In some examples,the axial frame members 116 comprise a plurality of axial support members 118 and a plurality of axial post struts 120, wherein the axial post struts 120 are attached to lower junctions 138 of the outflow rung 1140 from which commissure posts 122 extend, while the axial support members 118 are attached to lower junctions 138 of the outflow rung 1140 which are not connected to commissure posts 122. Stated otherwise, the axial post struts 120 are aligned with respective commissure posts 122, and can together form continuous axial frame portions passing through corresponding lower junctions 138 of the outflow rung 1140, while the axial support members 1 18 terminate at corresponding lower junctions 138 of the outflow rung 1 140 disposed between commissure posts 122. The axial frame members 116, including axial support members 118 and axial post struts 120, can be parallel to each other and / or to a central longitudinal axis CA of the prosthetic valve 100.

[0108] Each cell row 130 of the frame 102 comprises a plurality of cells 128 extending circumferentially such that each cell 128 is directly coupled to two circumferentially adjacent cells 128 on both sides thereof within the same cell row 130. The term "cell 128", as used herein, refers to a closed cell, having an enclosed perimeter defined by at least four struts 110.

[0109] In some examples, the outflow cells 1280 are coupled to adjacent outflow cells 1280 within the outflow cell row 1300 via axial frame members 116. The outflow cells 1280 of the exemplary valve 100 shown in Figs. 1A-1C can be generally hexagonal, each outflow cell 1280 defined between two outflow angled struts 1120 of the outflow rung 1140, four first subsequent angled struts 112S 1 of the first subsequent rung 114S 1, and two axial frame members 116 extending between the outflow rung 1140 and the first subsequent rung 114S1.

[0110] Cells 128S, 1281 of the subsequent cell rows 130S, 1301 can be generally diamond- shaped cells. For example, the frame 102 of exemplary prosthetic valve 100 is shown to include first subsequent cells 128S 1 defined by two first subsequent angled struts 112S1 and two second subsequent angled struts 112S2, second subsequent cells 128S2 defined by two second subsequent angled struts 112S2 and two third subsequent angled struts 112S3, third subsequent cells 128S3 defined by two third subsequent angled struts 112S3 and two fourth subsequent angled struts 112S4, and inflow cells 1281 defined by two fourth subsequent angled struts 112S4 and two inflow angled struts 1121.

[0111] A prosthetic valve 100 may be expanded against a calcified aortic annulus, requiring it to overcome the relatively increased rigidity of the calcified tissue during expansion. One of the factors known to affect the radial force exerted by the frame 102 of a valve 100 on the surrounding anatomy is the number of cells 128 in corresponding cell rows, wherein a greater number of cells 128 (i.e., a higher cell density) will result in a greater radial force duringexpansion. Thus, frames 102 of some types of prosthetic valves 100 may be provided with a relatively large number of cells 128 to increase the radial force to overcome the resistance of the calcified annular pathologies.

[0112] Some prosthetic valves may have an overall axial length, in their expanded state, that can place the outflow cell row 1300 at the level of the coronary ostia. For example, such valves 100 can be designed to have their outflow apices 132 contacting or being placed in the vicinity of the sinuses or the Sinotubular Junction (STJ) when expanded at the site of implantation. In some instances, a patient may require implantation of a coronary stent or other procedure that requires access to a coronary artery after prosthetic valve implantation. For such instances, a physician may need to access the coronary artery through the opening defined by an outflow cell 1280 of the outflow cell row 1300 facing the coronary ostium.

[0113] In some examples, the outflow cells 1280 of the prosthetic valve 100 can have a height (measured in the axial direction) which is greater than the height of cells 128S, 1281 of the subsequent cell rows 130S, 1301, due to the axial frame members 116 interconnecting the outflow rung 1140 and the first subsequent rung 114S1. In some examples, as further illustrated in Figs. 1A-1C, the outflow cells 1280 can have a width (measured in the circumferential direction, such as between two neighboring axial frame members 116) which is greater than the width of cells 128S, 1281 of the subsequent cell rows 130S, 1301.

[0114] The number of subsequent and / or cells 128S, 1281 of the subsequent and / or inflow cell rows 1308, 1301 can be chosen to be relatively large to provide sufficient radial force during expansion against the native annulus, which may result in a smaller width of these cells 128S, 1281. Taking advantage of the fact that increased radial force during valve expansion is required primarily at the region of the native annulus, corresponding to the lower portion (i.e., distal or inflow portion) of the frame, outflow cell row 1300 can include wider outflow cells 1280 than cells of the subsequent cell rows. The width of the outflow cells 1280 can be configured to be larger than the outer diameter of a selected coronary catheter (e.g., a 6 Fr coronary catheter).

[0115] In some examples, apices of the frame 102, such as any of the outflow apices 132, inflow apices 134, and free apices 136, comprise arcuate regions defined between upper and lower curved surfaces. Each outflow apex 132 and / or free apex 136 can include an arcuate apex region 140 defined between an upwardly convex-shaped upper curved surface 142 and an opposing lower curved surface 144 that can form an inner depression of the outflow apex 132 or free apex 136. Similarly, each inflow apex 134 can include an arcuate apex region 140 defined between a downwardly concave-shaped lower curved surface 144 and an opposing upper curved surface 142 that can form an inner depression of the inflow apex 134.

[0116] In some examples, the arcuate apex regions 140 of any of the outflow apices 132, inflow apices 134, and / or free apices 136, are narrower than the remainder of the corresponding angled struts 112 diverging therefrom. The term "width", as used herein with respect to a strut or an apex, refers to a dimension of a strut or an arcuate apex region measured between opposing locations on opposing surfaces of the strut or apex that extend between the radially facing inner and outer surfaces of the strut or apex, respectively.

[0117] In some instances, when the leaflets are in an open state when implanted in a patient, the leaflets can contact the free apices 136. In such cases, it is beneficial for the free apices 136 to have arcuate regions with curved outer surfaces, as illustrated in Figs. 1A-1C. The curved outer surface is more atraumatic and may not interfere with the leaflets of the prosthetic valve as the leaflets open and close during operation of the prosthetic valve. Thus, a long term durability of the leaflets can be increased.

[0118] While all apices of the exemplary frame 102 illustrated in Figs. 1A-1C are shown to include arcuate regions, it is to be understood that this is shown by way of illustration and not limitation, and that in some examples, any of the outflow apices 132, inflow apices 134, or free apices 136, can have any other shape, including being in the form of "pointed" apices devoid of arcuate regions, being shaped as M-shaped double-pointed apices, and the like.

[0119] In some examples, as shown in Figs. 1 A-1C, the length of an outflow angled strut 1120 is greater than the length of an angled strut 112S1 of the first subsequent rung 114S1, and / or any other subsequent rung 114S, 1141 of the frame 102. In some examples, the width of an outflow angled strut 1120 can be larger than the width of angled struts 112S1 of the first subsequent rung 114S1, and / or any other subsequent rung 114S, 1141 of the frame 102. It is to be understood that wider outflow angled struts 1120 along the outflow rung 1140 are shown and described by way of illustration and not limitation, and that in some examples, all angled struts 112 of a frame 102 can have similar widths.

[0120] In some examples, as illustrated in Figs. 1A-1C, each outflow cell 1280 can span a width of two subsequent cells 128S1 of the first subsequent cell row 130S1 and / or any other subsequent cell row 1308, 1301. In some examples, the outflow cell row 1300 includes six outflow cells 1280, while any subsequent cell row 1308, 1301 can include twelve cells 128. The axial support members 118 and axial post struts 120 can be alternately arranged around the circumference of the outflow cell row 1300, such that a single axial support member 118 can be disposed between each two successive axial post struts 120, and a single axial post strut 120 can be disposed between each two successive axial support member 118.

[0121] While all cells 128 of the subsequent cell rows 130S, 1301 are shown in the example illustrated in Figs. 1A-1C to have substantially the same size and shape, it is to be understood that in some examples, cells 128 of the subsequent cell rows 130S, 1301 can have different sizes and shapes.

[0122] In some examples, the valvular structure 50 can be formed as a unitary component having dedicated regions thereof defining integrally formed leaflets 52 that can be continuously interconnected at intermediate portions 66 (indicated, for example, in Fig. 2E). Such intermediate portions 66 can be secured to the frame 102 to form commissures 80.

[0123] In some examples, the plurality of leaflets 52 can be integrally formed as regions of a one-piece valvular structure 50, meaning that all of the leaflets 52 are continuous with each other without the need to otherwise couple them to each other (such as by suturing, adhering, and the like) to form the valvular structure 50.

[0124] The leaflets 52 can 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 valves, including the manner in which the valvular structure 50 can be coupled to the frame 102 of the prosthetic valve 100, 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.

[0125] As shown, for example, in Fig. 2E, each leaflet 52 includes a leaflet belly 54 which is the movable and unattached part of the leaflet, defined between a lower cusp line 56 and an upper free edge 58 of the leaflet. In some examples, leaflet bellies 54 described herein can have a three-dimensional and concave shape, thereby resulting in increased mobility of the leaflet when the prosthetic valve is implanted in a patient. As a result, the efficiency of the prosthetic valve including the valvular structure can be improved.

[0126] Various exemplary implementations for prosthetic valve 100, 200, 300 and / or components thereof, such as valvular structures 50 and commissures 80, 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, assembly 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, assembly or component, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary implementations. For example, a unitary valvular structures 50a, illustrated in Fig. 2E, is anexemplary implementation of a unitary valvular structures 50, and thus can include any of the features described for a prosthetic valve 100 throughout the current disclosure, except that intermediate portions 66 of the valvular structures 50afurther define integral commissure folds 74 and / or tabs 76. The terms "unitary valvular structure" and "valvular structure", as used herein, are interchangeable, and refer to a valvular structure which is a one-piece material.

[0127] Figs. 2A-2E show some stages in a method of forming an exemplary valvular structure 50a. Fig. 2A shows a flattened view of a patch 40 of material, which can be a tissue patch that can have a generally rectangular shape extending between side edges 42a and 42b. The patch is dimensioned to define a plurality of leaflets 52, each leaflet separated from an adjacent leaflet by an intermediate portion 66. Leaflets formed next to the side edges 42 are separated from the side edges 42 by corresponding side portions 68.

[0128] Fig. 2B shows the patch 40 of Fig. 2A, wherein intermediate slits 70 are formed at the intermediate portions 66. The slits 70 are distal to the free edges 58 and can optionally be rectangularly shaped. Side slits 72 can be optionally similarly formed next to the side edges 42 of the patch 40, so as to define opposing tabs 76a and 76b of the patch 40 extending from both side edges 42a and 42b, respectively. The side slits 72 can be axially aligned with the intermediate slits 70.

[0129] The relatively flat rectangular patch 40 can be optionally inserted into a mold assembly (not shown) and pressed between upper and lower templates, forcing it to assume a 3D-shaped configuration defined by the various surfaces of such templates. Fig. 2C shows the patch 40 in a 3D-shaped configuration, after removal from such a mold assembly. When the patch is formed of a tissue material (e.g., bovine pericardium), cross-linking the tissue patch 40 can result in the tissue maintaining its shape after being removed or separated from the mold assembly. As further illustrated in Fig. 2C, the regions of the intermediate portions 66 which are above (or proximal to) the intermediate slits 70 can be folded radially away from the plane of the patch 40, thereby forming integral commissure folds 74.

[0130] Fig. 2D shows an optional subsequent step of forming a tubular valvular structure 50 by rolling the 3D-shaped patch 40. For example, the side edges 42a and 42b can be brought together in a mating or otherwise abutting relationship. Once mated, both side edges 42a, 42b can be coupled to each other, such as by sewing, adhering, or otherwise attaching the side edges 42, thus resulting in a substantially cylindrical valvular structure 50 as shown in Fig. 2E. When the valvular structure 50 is rolled to assume its cylindrical configuration, as shown in Fig. 2E, each intermediate portion 66 can be folded so as to form an integral commissure fold 74 above the corresponding intermediate slit 70, extending radially outwards. The two tabs 76a, 76bextending from the side edges 42a, 42b are disposed next to each other when the patch 40 is rolled to a cylindrical form, and can be joined together to form a combined shape that can be optionally similar to that of an integral commissure fold 74.

[0131] Each leaflet 52 of the valvular structure 50, as shown in Fig. 2E, has a free edge 58 and a cusp line 56 that can have, in some examples, a curved shape, opposite to the free edge 58. The cusp line 56 of each leaflet 52 can form a single scallop that can be, for example, parabolic in shape. Integral commissure folds 74 and tabs 76 of the valvular structure 50acan extend from the level of the free edges 58 to the corresponding intermediate slits 70 and side slits 72, respectively. A leaf-shaped leaflet belly 54 of each leaflet 52 is defined between the cusp line 56 and the free edge 58, excluding the intermediate portions 66.

[0132] When the valvular structure 50 is coupled to the frame 102, a line of attachment, also referred to as a scalloped line, can extend along the cusp lines 56 of all leaflets 52, together forming a scalloped shaped attachment pattern that can be stitched or otherwise coupled to the frame, directly or indirectly. The scalloped line of attachment, following at least a portion of the cusp lines 56, such as parallel to and somewhat distal to the cusp lines, optionally without extending into the intermediate portions 66, can have an undulating, curved scalloped shape. By forming the leaflets of the valvular structure 50 with this scalloped geometry (such as along the cusp lines 56), stresses on the leaflets 52 are reduced which, in turn, improves durability of the prosthetic valve. The leaflet belly 54 of each leaflet 52 is the part of the leaflet 52 remaining unattached to the frame or other components of the valve after assembly, configured to open and close (or coapt) during operation of the prosthetic valve, such as during systole and diastole.

[0133] In some examples, the valvular structure 50 can optionally further comprise an engagement portion 62 extending between a distal end 64 thereof and the cusp lines 56, wherein the distal end 64 of the engagement portion 62 can be circular in the cylindrical configuration of the valvular structure 50, as shown for example in Fig. 2E, or substantially linear in a flattened configuration of the valvular structure 50, as shown in Figs. 2A-2C for example. In some examples, the engagement portion 62 can be cylindrically disposed along an inner surface of the frame 102, and coupled thereto, such as by sutures or other couplers that extend both through the scalloped line following at least a portion of the cusp lines 56, and the distal end 64 of the engagement portion 62.

[0134] In contrast to the leaflets 52, the engagement portion 62 can remain flattenable after the 3D-shaping process of the leaflets 52. Having a flattenable engagement portion 62 can assist in attachment thereof to the frame 102, wherein a flattenable engagement portion 62 can berolled into a cylindrical or semi-cylindrical shape that can conveniently cover the inner surface of the frame 102, while the leaflet bellies 54, which are movable portions that remain unattached to the frame, can be formed as portions which are not-flattenable to improve performance of the valvular structure 50.

[0135] In some examples, the distal end 64 of the engagement portion 62 can extend all the way towards, or terminate in close proximity to, the inflow end 106 of the frame 102. In some examples, the distal end 64 of the engagement portion 62 can extend all the way towards, or terminate in close proximity to, the inflow apices 134. In some examples, the distal end 64 of the engagement portion 62 is parallel to the inflow end 106. In some examples, the distal end 64 of the engagement portion 62 is curved, for example by generally tracking the scalloped shape of the cusp lines 56.

[0136] Figs. 3A and 3B are partial perspective views of an exemplary first commissure 80aI and an exemplary second commissure 80aS, respectively, mounted in corresponding commissure posts 122. A first commissure 801 is a commissure formed by an integral commissure fold 74, and a second commissure 80S is a commissure formed by the two tabs 76a, 76b joined together. Any prosthetic valve 100, 200, 300 disclosed herein can optionally comprises a single second commissure 80S and a plurality of first commissures 801. In some examples, the valvular structure 50 comprises three leaflets 52. In some examples, any prosthetic valve 100, 200, 300 disclosed herein can optionally comprises a single second commissure 80S and two first commissures 801.

[0137] The commissure post 122 of prosthetic valve 100 comprises window opening 124 that can optionally be a closed window opening bound between sidewalls 126 and upper lateral strut portion.

[0138] An exemplary first commissure 80aI is formed by extending an integral commissure fold 74 of a valvular structure 50aradially outwards through a corresponding window opening 124, as shown in Fig. 3A. The integral commissure fold 74 forms a tube-like structure that defines a channel 82 extending axially therethrough, radially outwards to the commissure port 122. A wedge member 90 is then inserted into the channel 82, such that the total width Wc of the commissure 801 (indicated, for example, in Fig. 3A), is greater than the width Wo (indicated, for example, in Fig. 1C) of the width of the window opening 124, thereby preventing, or at least restraining, passage of the outer portion of the first commissure 801 radially inward past the window opening 124. The total width Wc of a commissure 801 is dictated by the thickness Tw of the wedge member 90 and twice the thickness Tv of the valvular structure 50 (contributing the thickness Tv on each side of the integral commissure fold 74surrounding the wedge member 90). In some examples, additional optional components included in a commissure 801 can further widen the commissure 801.

[0139] An exemplary second commissure 80aS is formed by extending the tabs 76a, 76b of a valvular structure 50aradially outwards through a corresponding window opening 124, as shown in Fig. 3B. The portions of the tabs 76a, 76b extending out of the window opening 124 are wrapped over a wedge member 90, such that the total width Wc of the commissure 80S (indicated, for example, in Fig. 3B), is greater than the width Wo of the width of the window opening 124, thereby preventing, or at least restraining, passage of the outer portion of the first commissure 80S radially inward past the window opening 124. The total width Wc of a commissure 80S is dictated by the thickness Tw of the wedge member 90 and twice the thickness Tv of the valvular structure 50 (contributing the thicknesses Tv of both tabs 76 disposed on opposite sides of the wedge member 90). In some examples, additional optional components included in a commissure 801 can further widen the commissure 80S.

[0140] One or more sutures (not shown) can be employed to attached different portion of a commissure 80ato each other. For example, a suture can be stitched through both tabs 76a, 76b and a corresponding wedge member 90 to couple them to each other at the portion of the second commissure 80S extending out of the window opening 124. Similarly, a suture can be stitched through the integral commissure fold 74 and the corresponding wedge member 90 to couple them to each other at the portion of the first commissure 801 extending out of the window opening 124. It is to be understood that any other number and positions of sutures or other coupling members can be employed. For example, components of a commissure 80acan be attached to each other by stapling, gluing, welding, and the like.

[0141] Optionally, the height of the integral commissure folds 74 and tabs 76, defined by the distance of the intermediate slits 70 and side slits 72 from the level of the free edges 58, can generally match the height of the window openings 124.

[0142] A wedge members 90 can be formed from a relatively thick, multi-filament or monofilament suture, yarn or cable (e.g., a braided, polyester suture, such as an Ethibond suture), a piece of cloth or fabric folded one or more times to increase its thickness, or any other structure. In some examples, the disclosed wedge members 90, or sutures coupled thereto, can be formed of a material that does not encourage tissue ingrowth, such as ultra-high molecular weight polyethylene (UHMPE), polyethylene terephthalate (PET), polyurethane (PU), or polytetrafluoroethylene (PTFE). In some examples, the disclosed wedge members 90 can comprise a material that is minimally porous, configured to prevent or minimize neovascularization, or does not allow tissue anchoring can be used for the disclosed wedgemembers. In some examples, the disclosed wedge members 90 can be a coated or laminated polymeric material. In some examples, the disclosed wedge members 90 can comprise a polymer material that is processed in a manner, or otherwise configured, to reduce the likelihood for tissue ingrowth. For example, if exposure of the material to certain levels of heat may induce thrombogenicity, the materials for the disclosed wedge members may be processed in a manner that avoids or reduces such heating steps.

[0143] While coupling of a commissure 80 to a commissure post 122 that includes a closed window opening 124 enclosed by an upper lateral strut portion 137 is illustrated in Figs. 3A- 3B, it is to be understood that in some examples, a commissure post 122 can be devoid of an upper lateral strut portion 137, such that the window opening 124 is open ended towards the outflow end 104. In such examples, integral commissure folds 74 and / or tabs 76 can be passed from the upper openings of the commissure posts 122 into the window openings 124, from the radially-inner side to the radially-outer side of the commissure posts 122.

[0144] Commissure posts 122 and window openings 124 thereof, to which first commissures 801 are coupled, can also be referred to, throughout the specification and the claims, as first commissure posts 122 and first window openings 124 thereof. Similarly, commissure posts 122 and window openings 124 thereof, to which second commissures 80S are coupled, can also be referred to, throughout the specification and the claims, as second commissure posts 122 and second window openings 124.

[0145] Any wedge member 90 extending through any first commissure 801 disclosed herein (for any exemplary valve 100, 200 or 300) can be referred to, throughout the specification and the claims, as a first wedge member. Similarly, any wedge member 90 extending through any second commissure 80S disclosed herein (for any exemplary valve 100, 200 or 300) can be referred to, throughout the specification and the claims, as a second wedge member.

[0146] Figs. 4A and 4B show a side view and a perspective view of an example of a prosthetic valve 200, with and without soft components (such as skirts and a valvular structure), respectively. The prosthetic valve 200 comprises an inflow end 206 and an outflow end 204. In some instances, the inflow end 206 is the distal end of the prosthetic valve 200, and the outflow end 204 is the proximal end of the prosthetic valve 200. Alternatively, depending for example on the delivery approach of the valve, the inflow end can be the proximal end of the prosthetic valve, and the outflow end can be the distal end of the prosthetic valve.

[0147] The valve 200 comprises an annular frame 202 movable between a radially compressed state and a radially expanded state, and a valvular structure 50 mounted within the frame 202. The frame 202 can be made of various suitable plastically-expandable materials (e.g., stainlesssteel, etc.) or self-expanding materials (e.g., Nitinol). When constructed of a plastically - expandable material, the frame 202 (and thus the valve 200) can be crimped to a radially compressed state on a balloon catheter (not shown), and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 202 (and thus the valve 200) 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.

[0148] Suitable plastically-expandable materials that can optionally be used to form the frames disclosed herein (e.g., the frame 202) 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 202 comprises stainless steel. In some examples, the frame 202 comprises cobalt-chromium. In some examples, the frame 202 comprises nickel-cobalt-chromium. In some examples, the frame 202 a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0149] In the example illustrated in Figs. 4A-4B, the frame 202 is an annular, stent- like structure comprising a plurality of intersecting struts 210 which form multiple rows 230 of cells 228 between the outflow end 204 and the inflow end 206 of the frame 202. A strut 210 may be any elongated member or portion of the frame 202. The frame 202 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 206 to the outflow end 204 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.

[0150] Two or more struts 210 can intersect at junctions 238, which can be equally or unequally spaced apart from each other. The struts 210 may be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 202 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.

[0151] Figs. 4A-4B show an exemplary prosthetic valve 200 that can be representative of, but is not limited to, a balloon expandable prosthetic valve. In some examples, the struts 210 comprise angled struts 212 and axial frame members 216. The frame 202 can further comprisea plurality of outflow apices 232 at the outflow end 204 of the frame, and a plurality of inflow apices 234 at the inflow end 206 of the frame. A plurality of intermediate junctions 238 are disposed between the inflow end 206 and outflow end 204.

[0152] The frame 202 includes an outflow cell row 2300, an inflow cell row 2301, and optionally (but not necessarily) one or more subsequent cell rows 230S therebetween. In the example illustrated in Figs. 4A-4B, the frame 202 is shown to comprises four cell rows 230, each row comprising a plurality of cells 228 extending circumferentially such that each cell 228 is directly coupled to two circumferentially adjacent cells 228 on both sides thereof within the same row of cells. The term "cell 228", as used herein, refers to a closed cell, having an enclosed perimeter defined by at least four struts 210. The outflow cell row 2300, disposed at the outflow end 204, comprises outflow cells 2280 that are elongated in an axial direction, compared to cells 228 in the remaining cell rows 230, which can include a first subsequent cell row 230S1, a second subsequent cell row 230S2, and the inflow cell row 2301.

[0153] In some examples, such as shown in Figs. 4A-4B, each cell row 230 comprises twelve cells 228. Thus, the frame 202 can be referred to as a twelve-cell frame. In other examples, the frame 202 can have a greater or fewer number of circumferentially extending cell rows 230 and / or a greater or fewer number of cells 228 in each cell row.

[0154] In some examples, cells 228 are coupled to adjacent cells 228 within the same row, such as within the outflow (or proximal-most) cell row 2300, via axial frame members 216. Axial frame members 216 include, in some examples, commissure support members 222 and non-commissural axial struts 218. A commissure support member 222 is configured to support a corresponding commissure 80 of the valvular structure 50. The axial frame members 216, including non-commissural axial struts 218 and commissure support members 222, can optionally be parallel to each other.

[0155] In some examples, a commissure support member 222 can optionally comprise a window opening 224 defined between two axially-extending sidewalls 226. 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 50. That is to say, an axial struts 218 is not configured to mount a commissure, and may be devoid of a window opening 224.

[0156] The frame 202 includes an outflow rung 2140, an inflow rung 2141, and one or more subsequent rungs 214S therebetween, which can be also referred to as intermediate rungs. In the example illustrated in Figs. 4A-4B, the frame 202 is shown to comprise five rungs 214 of angled struts 212, including the outflow rung 2140 of angled outflow struts 2120 which iscloser to the outflow end 204 relative to other rungs of struts, a first subsequent rung 214S1 of angled struts 212S1 which is distal to the outflow rung 2140, a second subsequent rung 214S2 of angled struts 212S2 which is distal to the first subsequent rung 214S1, a third subsequent rung 214S3 of angled struts 212S3 which is distal to the second subsequent rung 214S2, and the inflow rung 2141, which includes angled inflow struts 2121 that are closer to the inflow end 206 relative to other rungs of struts. It is to be understood that a frame 202 can optionally include less or more than five rungs.

[0157] One or more (for example, two, as shown in Figs. 4A-4B) axial struts 218 can be positioned between, in the circumferential direction, two commissure support members 222. In some examples, each axial strut 218 can have a width that is larger than a width of the angled struts 212. In some examples, the width of the axial struts 218 is 50-200%, 75-150%, or at least 100% larger than (e.g., double) the width of the angled struts 212 of the frame 202.

[0158] By providing the axial struts 218 with the width that is greater than the width of other, angled struts 212 of the frame 202, a larger contact area is provided for when the leaflets 52 contact the wider axial struts 218 during systole, thereby distributing the stress and reducing the extent to which the leaflets may fold over the axial struts 218, radially outward through the outflow cells 2280. As a result, a long-term durability of the leaflets can be increased.

[0159] The outflow cells 2280 of the outflow cell row 2300 of the exemplary frame 202 illustrated in Figs. 4A-4B are shown to be generally hexagonal, each cell defined between two outflow angled struts 2120 of the outflow rung 2140, two angled struts 212S1 of the first subsequent rung 214S1, and two axial frame members 216 extending between the outflow rung 2140 and the first subsequent rung 214S1. Cells of the first subsequent cell row 230S1, second subsequent cell row 230S2, and inflow cell row 2301, can be generally diamond- shaped cells, with the cells 228S1 of the first subsequent cell row 230S 1 defined by two angled struts 212S1 of the first subsequent rung 214S1 and two angled struts 212S2 of the second subsequent rung 214S2, cells 228S2 of the second subsequent cell row 230S2 defined by two angled struts 212S2 of the second subsequent rung 214S2 and two angled struts 212S3 of the third subsequent rung 214S3, and inflow cells 2281 of the inflow cell row 2301 defined by two angled struts 212S3 of the third subsequent rung 214S3 and two angled struts 2121 of the inflow rung 2141.

[0160] Each rung 214 of angled struts 212 is shown to be circumferentially arranged in a generally zig-zagged pattern. Each axial frame member 216 is linked at an upper end thereof to outflow angled struts 2120 of the outflow rung 2140, and is linked at a lower end thereof to angled struts 212S 1 of the first subsequent rung 214S 1.

[0161] As mentioned above, while three rows 230 of cells 228 defined between five rungs 214 of angled struts 212 are illustrated, it is to be understood that any exemplary prosthetic valve 200 disclosed herein can include any other number of cell rows 230 and strut rungs 214.

[0162] In some examples, the prosthetic valve 200 can optionally include an inner skirt 246 secured to an inner surface 207 of the frame 202. In some examples, the prosthetic valve 200 can include an outer skirt 248 mounted on an outer surface 208 of the frame 202. Any of the inner skirt 246 or outer skirt 248 can be similar to any example described above for an inner skirt 146 or outer skirt 148, respectively, of prosthetic valve 100.

[0163] In some examples, apices of the frame 202, such as any of the outflow apices 232 and inflow apices 234, comprise arcuate regions defined between upper and lower curved surfaces. Each outflow apex 232 can include an arcuate apex region 240 defined between an upwardly convex-shaped upper curved surface 242 and an opposing lower curved surface 244 that can form an inner depression of the outflow apex 232. Similarly, each inflow apex 234 can include an arcuate apex region 240 defined between a downwardly concave-shaped lower curved surface 244 and an opposing upper curved surface 242 that can form an inner depression of the inflow apex 234.

[0164] In some examples, the arcuate apex regions 240 of any of the outflow apices 232 and / or inflow apices 234, are narrower than the remainder of the corresponding angled struts 212 diverging therefrom. While all apices of the exemplary frame 202 illustrated in Figs. 4A-4B are shown to include arcuate regions, it is to be understood that this is shown by way of illustration and not limitation, and that in some examples, any of the outflow apices 232 and / or inflow apices 234 can have any other shape, including being in the form of "pointed" apices devoid of arcuate regions, being shaped as M-shaped double-pointed apices, and the like.

[0165] Fig. 4A shows an exemplary prosthetic valve 200b, which is an exemplary implementation of a prosthetic valve 200, and thus can include any of the features described for a prosthetic valve 200 throughout the current disclosure, except that the prosthetic valve 200bincludes a valvular structure 50bforming exemplary commissures 80b. Fig. 5 is a perspective view of an enlarged portion of the prosthetic valve 200bthat includes a commissure 80b.

[0166] An exemplary valvular structure 50bcan be similar to any example described herein for a valvular structure 50athat includes integral commissure folds 74, except that the valvular structure 50bfurther defines pockets 84 extending distally from the slits 70 and / or slits 72, as also illustrated, for example, in Fig. 2E. Pockets 84 can be formed distal to the integralcommissure folds 74, as well as distal to tabs 76 which are joined together in the cylindrical configuration of the valvular structure 50b.

[0167] Pockets 84 which are distal to the integral commissure folds 74 can be formed by folding the material of the valvular structure 50bdistally extending from the intermediate slits 70 radially outwards, such that the upper end of the pocket 84, defined by the edge of the slit 70, extends radially outwards to a distance that can be similar to that of the corresponding integral commissure fold 74, and converges radially inwards in the distal direction towards the surface defined by the engagement portion 62.

[0168] Pockets 84 which are distal to the tabs 76 can be formed by extending portions of the side edges 42 that extend distally from the side slits 72 radially outwards, and folding them over each other, in a manner that forms a structure substantially similar to that described above with respect to the pockets 84 which are aligned with the integral commissure fold 74.

[0169] The commissure 80billustrated in Fig. 5 can be representative of a first commissure 80bI, which can be formed by extending an integral commissure fold 74 of a valvular structure 50bradially outwards through a corresponding window opening 224, and extending a pocket 84 circumferentially aligned with the integral commissure fold 74 radially outwards through an axially-adjacent cell 228 which is distal to the commissure support member 222, such as an axially-adjacent cell 128S1 of the first subsequent cell row 130S1.

[0170] A wedge member 90 is then inserted through the channel 82 of the integral commissure fold 74 towards and into pocket 84, such that in addition to forming a width of the commissure portion which is radially outwards to the window opening 224, configured to prevent or restrain it from slipping radially inwards, the portion of the wedge member 90 extending across the intermediate slit 70 is also supported against (e.g., outwardly from) a junction 238c connecting the commissure support member 222 with the corresponding axially-adjacent cell 228S1, so as to improve securement of the commissure 80bI to the frame 202.

[0171] While the commissure 80billustrated in Fig. 5 may be exemplary of a first commissure 80bI of prosthetic valve 200b, it is to be understood that a second commissure 80bS can be similarly formed for prosthetic valve 200bby extending the tabs 76a, 76b of a valvular structure 50bradially outwards through a corresponding window opening 224, and forming a pocket 84 aligned with the joined tabs 76 by extending portions of the side edges 42a, 42b extending distally from the side slits 72 radially outwards through an axially-adjacent cell 228 which is distal to the corresponding commissure support member 222, such as an axially-adjacent cell 128S1 of the first subsequent cell row 13081.

[0172] The portions of the tabs 76a, 76b extending out of the window opening 124 are wrapped over an upper portion of the wedge member 90 positioned in front (e.g., radially outwards from) the window opening 224, and portions of the side edges 42a, 42b extending out of the corresponding axially- adjacent cell 228 (e.g., cell 228S1 of the first subsequent cell row 230S1) are similarly wrapped over a lower portion of the wedge member 90 positioned in front of the cell 228 (e.g., radially outwards from, and along at least an upper part of, the cell 228S1). In this manner, in addition to forming a width of the commissure portion which is radially outwards to the window opening 224, configured to prevent or restrain it from slipping radially inwards, the portion of the wedge member 90 extending across the side slits 72 is also supported against (e.g., outwardly from) a junction 238c connecting the commissure support member 222 with the corresponding axially-adjacent cell 228S1, so as to improve securement of the commissure 80bS to the frame 202.

[0173] One or more sutures or other suitable couplers (not shown) can be employed to attached different portion of a commissure 80bof prosthetic valve 200bto each other, in a similar manner to that described above with respect to the first and second commissures of prosthetic valve 100. Optionally, the height of the integral commissure folds 74 and tabs 76 of a valvular structure 50b, defined by the distance of the intermediate slits 70 and side slits 72 from the level of the free edges 58, can generally match the height of the window openings 224. The height (in the axial direction) of the intermediate slit 70 and side slits 72 can be set to accommodate the junction 238c connecting the commissure support member 222 with the corresponding axially-adjacent cell 228S1.

[0174] While an exemplary prosthetic valve 200bis described above and illustrated in Figs. 4A and 5 to includes commissures 80bof a valvular structure 50b, it is to be understood that a prosthetic valve 200 can similarly include a valvular structure 50athat doe not necessarily define pockets 84, in which case commissures 80“ of the type described above with respect to Figs. 3A-3B can be similarly formed in a prosthetic valve 200, mutatis mutandis.

[0175] Commissure support members 222 and window openings 224 thereof, to which first commissures 801 are coupled, can also be referred to, throughout the specification and the claims, as first commissure support members 222 and first window openings 224 thereof. Similarly, commissure support members 222 and window opening 224 thereof, to which second commissures 80S are coupled, can also be referred to, throughout the specification and the claims, as second commissure support members 222 and second window openings 224.

[0176] Fig. 6 shows a frame 202cof an exemplary prosthetic valve 200c. Prosthetic valve 200cis an exemplary implementation of a prosthetic valve 200, and thus can include any of thefeatures described for a prosthetic valve 200 throughout the current disclosure, except that the frame 202cof prosthetic valve 200cincludes H-shaped commissure support members 222c.

[0177] As shown in Fig. 6, each commissure support members 222ccan optionally comprise a crossbar 220 extending between the sidewalls 226 along the circumferential direction and connecting with both sidewalls 226, thereby dividing a spacing between the sidewalls 226 into an upper window opening 224U and a lower window opening 224L. In this manner, each commissure support member 222ccan be optionally constructed to have a substantially H- shape in respective side view.

[0178] The upper window opening 224U can optionally be open to the outflow end 204 along the axial direction of the valve 200. The lower window opening 224L can optionally be open to an adjacent cell 228 along the axial direction of the valve 200c, such as an adjacent cell 228S 1 of the first subsequent cell row 230S1.

[0179] In some examples, a valvular structure 50bthat includes integral commissure folds 74 and pockets 84, can be mounted inside frame 202c. Figs. 7A and 7B are partial perspective views of an exemplary first commissure 80bI and an exemplary second commissure 80bS, respectively, mounted in corresponding commissure support members 222c.

[0180] An exemplary first commissure 80bI of prosthetic valve 200ccan be formed by extending an integral commissure fold 74 of a valvular structure 50bradially outwards through an upper window opening 224U, and extending a pocket 84 circumferentially aligned with the integral commissure fold 74 radially outwards through the respective lower window opening 224L. A wedge member 90 is then inserted through the channel 82 of the integral commissure fold 74 towards and into pocket 84, such that in addition to forming a width of the commissure portions which are radially outwards to the upper and lower window openings 224U, 224L, configured to prevent or restrain these commissure portions from slipping radially inwards, the portion of the wedge member 90 extending across the intermediate slit 70 is also supported against crossbar 220, so as to improve securement of the commissure 80bI to the commissure support member 222c.

[0181] An exemplary second commissure 80bS of prosthetic valve 200ccan be formed by extending the tabs 76a, 76b of a valvular structure 50bradially outwards through an upper window opening 224U, and forming a pocket 84 aligned with the joined tabs 76 by extending portions of the side edges 42a, 42b extending distally from the side slits 72 radially outwards through the respective lower window opening 224L.

[0182] The portions of the tabs 76a, 76b extending out of the upper window opening 224U are wrapped over an upper portion of the wedge member 90 positioned in front (e.g., radiallyoutwards from) the upper window opening 224U, and portions of the side edges 42a, 42b extending out of the corresponding lower window opening 224L are similarly wrapped over a lower portion of the wedge member 90 positioned in front of the lower window opening 224L. In this manner, in addition to forming a width of the commissure portion which is radially outwards to the upper and lower window openings 224U, 224L, configured to prevent or restrain these commissure portions from slipping radially inwards, the portion of the wedge member 90 extending across the side slits 72 is also supported against crossbar 220, so as to improve securement of the commissure 80bS to the commissure support member 222c.

[0183] One or more sutures or other suitable couplers (not shown) can be employed to attached different portion of a commissure 80bof prosthetic valve 200cto each other, in a similar manner to that described above. Optionally, the height of the integral commissure folds 74 and tabs 76 of a valvular structure 50b, defined by the distance of the intermediate slits 70 and side slits 72 from the level of the free edges 58, can generally match the height of the upper window openings 224U, which can be optionally shorter than the heights shown in Figs. 4A and 5 for commissures 80bof a prosthetic valve 200b. The height (in the axial direction) of the intermediate slit 70 and side slits 72 can be set to accommodate the crossbar 220 disposed between the upper window opening 224U and the lower window opening 224L.

[0184] As used herein, the term "upper" and "lower" may be relative to a central longitudinal axis CA of a prosthetic valve (e.g., prosthetic valve 100, 200, or 300) when the valvular structure 50 is installed and coupled to frame, with upper being closer to the outflow end of the valve and lower being closer to the inflow end of the valve.

[0185] In some examples, the tabs 76a, 76b of any exemplary second commissure 80S disclosed herein, can be coupled together prior to insertion through a window opening 224 or an upper window opening 224U. In some examples, upper portions of side edges 42a, 42b of any exemplary second commissure 80bS disclosed herein, can be coupled together so as to form a pocket 84 prior to insertion through a cell 228 (e.g., cell 228S1) or a lower window opening 224L.

[0186] In some examples, integral commissure folds 74 and / or tabs 76 can be passed from upper openings of the commissure support members 222cinto the upper window openings 224U, from the radially-inner side to the radially-outer side of the commissure support member 222c. In some examples, pockets 84 and / or portions of the side edges 42 can be passed from lower openings of the commissure support members 222cinto the lower window openings 224L, from the radially-inner side to the radially-outer side of the commissure support member 222c.

[0187] It is to be understood that any of the commissures 80 disclosed herein can optionally include additional components, such as a flexible cloth or fabric (not shown) that can be optionally disposed around surfaces of an integral commissure fold 74 and / or tabs 76 and / or wedge member(s) 90 and / or portions of a commissure post 122 or a commissure support member 222, optionally configured to protect portions of the valvular structure 50 from abrasion.

[0188] Fig. 8 shows a frame 202dof an exemplary prosthetic valve 200d. Frame 202dcan be similar to any example described herein for frame 202c, except that a commissure support member 222dof the frame 202dfurther comprises an upper lateral strut portion 236U extending between the upper ends of the sidewalls 226 and forming a closed end of the upper window opening 224U, and a lower lateral strut portion 236L extending between the lower ends of the sidewalls 226 and forming a closed end of the lower window opening 224L. The lateral strut portions 236U, 236L are spaced in the axial direction of the frame 202dand extend in the circumferential direction of the frame 202d. The upper window opening 224U is enclosed by the sidewalls 226, the upper lateral strut portion 236U, and the crossbar 220. The lower window opening 224L is enclosed by the sidewalls 226, the lower lateral strut portion 236L, and the crossbar 220. The resulting commissure support member 222dcan be described as having an H-shape with closed ends, where the sidewalls 226 and the crossbar 220 form the H-shape (as in the commissure support member 222c) and the lateral strut portions 236U, 236L form the closed ends. A lower lateral strut portion 236L can optionally define, or be part of, a junction 238c connecting the commissure support member 222dwith an axially-adjacent cell 228S1.

[0189] The crossbar 220 and the lateral strut portions 236U, 236L can enable the commissure support member 222dto be elongated in form. Elongated commissure support members can accommodate longer integral commissure folds (the length or height being measured in the axial direction), which are useful in relieving stresses applied to the leaflets during the transition between the systolic and diastolic phases. The crossbar 220 divides the commissure support member into sub- window portions such that the sidewall portions of each sub- window portion extend over a shorter length, allowing the sub-window portion to retain its structural integrity and resist bending / plastic deformation under load, such as when the prosthetic valve is crimped to a radially compressed state. The lateral strut portions 236U, 236L affixed to the ends of the sidewalls 226 advantageously increase the structural stability of the sidewalls 226.

[0190] In some examples, a prosthetic valve 200dcan optionally include an exemplary valvular structure 50dmounted inside its frame 202d. Fig. 9 shows a flattened view of a valvular structure 50d, prior to being rolled into a cylindrical form thereof. Valvular structure 50dis an exemplaryimplementation of a valvular structure 50, and thus can include any of the features described for a valvular structure 50 throughout the current disclosure, except that the valvular structure 50dcomprises upper intermediate slits 70U and lower intermediate slits 70L (indicated, for example, in Fig. 9) configured to define upper integral commissure folds 74U and lower integral commissure folds 74L (indicated, for example, in Fig. 10A). A valvular structure 50dcan optionally further comprise upper side slits 72U and lower side slits 72L (indicated, for example, in Fig. 9) configured to define upper tabs 76U and lower tabs 76L (indicated, for example, in Fig. 10B).

[0191] Pairs of upper and lower intermediate slits 70U, 70L can be axially spaced from each other, such that each upper integral commissure fold 74U axially extends between the level of the free edges 58 and an upper intermediate slit 70U, and each lower integral commissure fold 74L axially extends between an upper intermediate slit 70U and a corresponding lower intermediate slit 70L. The upper and lower side slits 72U, 72L formed at each of the side edges 42 can be similarly axially spaced from each other, such that each upper tab 76U axially extends between the level of the free edges 58 and an upper side slit 72U, and each lower tab 76L axially extends between an upper side slit 72U and a corresponding lower side slit 72L. The upper side slits 72U can be axially aligned with the upper intermediate slits 70U, and the lower side slits 72L can be axially aligned with the lower intermediate slits 70L.

[0192] Figs. 10A and 10B are partial perspective views of an exemplary first commissure 80dI and an exemplary second commissure 80dS, respectively, mounted in corresponding commissure support members 222d.

[0193] An exemplary first commissure 80dI of prosthetic valve 200dcan be formed by extending an upper integral commissure fold 74U radially outwards through an upper window opening 224U, and extending the lower integral commissure fold 74L which is circumferentially aligned with the upper integral commissure fold 74U, radially outwards through the respective lower window opening 224L. A wedge member 90 is then inserted through an upper channel 82U of the upper integral commissure fold 74U and through a lower channel 82L of the lower integral commissure fold 74L, such that in addition to forming a width of the commissure portions which are radially outwards to the upper and lower window openings 224U, 224L, configured to prevent or restrain these commissure portions from slipping radially inwards, the portion of the wedge member 90 extending across the intermediate slit 70 is also supported against crossbar 220, so as to improve securement of the commissure 80dI to the commissure support member 222d.

[0194] An exemplary second commissure 80dS of prosthetic valve 200dcan be formed by extending the upper tabs 76Ua, 76Ub radially outwards through an upper window opening 224U, and extending the corresponding lower tabs 76La, 76Lb radially outwards through the respective lower window opening 224L.

[0195] The portions of the upper tabs 76Ua, 76Ub extending out of the upper window opening 224U are wrapped over an upper portion of the wedge member 90 positioned in front (e.g., radially outwards from) the upper window opening 224U, and the portions of the lower tabs 76La, 76Lb extending out of the corresponding lower window opening 224L are similarly wrapped over a lower portion of the wedge member 90 positioned in front of the lower window opening 224L. In this manner, in addition to forming a width of the commissure portion which is radially outwards to the upper and lower window openings 224U, 224L, configured to prevent or restrain these commissure portions from slipping radially inwards, the portion of the wedge member 90 extending across the upper side slits 72U is also supported against crossbar 220, so as to improve securement of the commissure 80dS to the commissure support member 222d.

[0196] One or more sutures (not shown) can be employed to attached different portion of a commissure 80dto each other, in a similar manner to that described above. The height of the upper integral commissure folds 74U and upper tabs 76U, defined by the distance of the upper intermediate slits 70U and upper side slits 72U from the level of the free edges 58, can optionally match the height of the upper window openings 224U. Similarly, the height of the lower integral commissure folds 74L and lower tabs 76L, defined by the distance of the lower intermediate slits 70L and lower side slits 72L from the level of the upper intermediate slits 70U and upper side slits 72U, respectively, can optionally match the height of the lower window openings 224L. The height (in the axial direction) of the upper intermediate slit 70U and upper side slits 72U can be set to accommodate the crossbar 220 disposed between the upper window opening 224U and the lower window opening 224L.

[0197] In some examples, the upper tabs 76Ua, 76Ub can be optionally coupled together prior to insertion through an upper window opening 224U, and the lower tabs 76La, 76Lb can be optionally coupled together prior to insertion through a lower window opening 224L.

[0198] In some examples, pockets 84 can be additionally formed in a valvular structure 50dbelow (e.g., distal to) the lower intermediate slits 70L and lower side slits 72L, in a similar manner to that described above for a valvular structure 50b, mutatis mutandis. In such examples, the pocket 84 can extend radially outwards through a cell 228 which is adjacent to the corresponding commissure support member 222dalong the axial direction of the valve 200d,such as an axially-adjacent cell 228S1 of the first subsequent cell row 230S1, and a wedge member 90 can extend from an upper channel 82U, across the crossbar 220, through the lower channel 82L, across the lower lateral strut portion 236L, and into the pocket 84.

[0199] Fig. 11 shows a side view of an example of a prosthetic valve 300. Fig. 12 is a perspective view of a portion of the prosthetic valve 300 that includes a commissure 80, with optional skirts thereof removed from view for clarity. The prosthetic valve 300 comprises an inflow end 306 and an outflow end 304. In some instances, the inflow end 306 is the distal end of the prosthetic valve 300, and the outflow end 304 is the proximal end of the prosthetic valve 300. Alternatively, depending for example on the delivery approach of the valve, the inflow end can be the proximal end of the prosthetic valve, and the outflow end can be the distal end of the prosthetic valve.

[0200] The valve 300 comprises an annular frame 302 movable between a radially compressed state and a radially expanded state, and a valvular structure 50 mounted within the frame 302. The frame 302 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 302 (and thus the valve 300) can be crimped to a radially compressed state on a balloon catheter (not shown), and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 302 (and thus the valve 300) 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.

[0201] Suitable plastically-expandable materials that can optionally be used to form the frames disclosed herein (e.g., the frame 302) 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 302 comprises stainless steel. In some examples, the frame 302 comprises cobalt-chromium. In some examples, the frame 302 comprises nickel-cobalt-chromium. In some examples, the frame 202 a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0202] In the example illustrated in Figs. 11-12, the frame 302 is an annular, stent-like structure comprising a plurality of intersecting struts 310 which form multiple rows 330 of cells 328between the outflow end 304 and the inflow end 306 of the frame 302. A strut 310 may be any elongated member or portion of the frame 302. The frame 302 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 306 to the outflow end 304 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.

[0203] Two or more struts 310 can intersect at junctions 338, which can be equally or unequally spaced apart from each other. The struts 310 may be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 302 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. In some examples, the struts 310 comprise angled struts 312.

[0204] Figs. 11-12 show an exemplary prosthetic valve 300 that can be representative of, but is not limited to, a balloon expandable prosthetic valve. The frame 302 can further comprise a plurality of outflow apices 332 at the outflow end 304 of the frame, and a plurality of inflow apices 334 at the inflow end 306 of the frame. A plurality of intermediate junctions 338 are disposed between the inflow end 306 and outflow end 304.

[0205] The frame 202 includes an outflow cell row 3300, an inflow cell row 3301, and optionally (but not necessarily) one or more subsequent cell rows 330S therebetween. In the example illustrated in Figs. 11-12, the frame 302 is shown to comprises four cell rows 330, each row comprising a plurality of cells 328 extending circumferentially such that each cell 328 is directly coupled to two circumferentially adjacent cells 328 on both sides thereof within the same row of cells. The term "cell 328", as used herein, refers to a closed cell, having an enclosed perimeter defined by at least four struts 310. The outflow cell row 3300, disposed at the outflow end 304, comprises outflow cells 3280 that are elongated in an axial direction, compared to cells 328 in the remaining cell rows 330, which can include a first subsequent cell row 330S1, a second subsequent cell row 330S2, and the inflow cell row 3301. In some examples, the frame 302 of a prosthetic valve 300 can be devoid of axial frame members or axially-extending commissure support members that define window openings.

[0206] The frame 302 includes an outflow rung 3140, an inflow rung 3141, and one or more subsequent rungs 314S therebetween, which can be also referred to as intermediate rungs. In the example illustrated in Figs. 11-12, the frame 302 is shown to comprise five rungs 314 of angled struts 312, including the outflow rung 3140 of angled outflow struts 3120 which is closer to the outflow end 304 relative to other rungs of struts, a first subsequent rung 314S1 ofangled struts 312S1 which is distal to the outflow rung 3140, a second subsequent rung 314S2 of angled struts 312S2 which is distal to the first subsequent rung 314S 1, a third subsequent rung 314S3 of angled struts 312S3 which is distal to the second subsequent rung 314S2, and the inflow rung 3141, which includes angled inflow struts 3121 that are closer to the inflow end 306 relative to other rungs of struts. It is to be understood that a frame 302 can optionally include less or more than five rungs.

[0207] The cells 328 of frame 302 can be generally diamond- shaped cells, with outflow cells 3280 of the outflow cell row 3300 defined between two outflow angled struts 3120 of the outflow rung 3140 and two angled struts 312S1 of the first subsequent rung 314S1, cells 328S1 of the first subsequent cell row 330S1 defined by two angled struts 312S1 of the first subsequent rung 314S1 and two angled struts 312S2 of the second subsequent rung 314S2, cells 328S2 of the second subsequent cell row 330S2 defined by two angled struts 312S2 of the second subsequent rung 314S2 and two angled struts 312S3 of the third subsequent rung 314S3, and inflow cells 3281 of the inflow cell row 3301 defined by two angled struts 312S3 of the third subsequent rung 314S3 and two angled struts 3121 of the inflow rung 3141. Each rung 314 of angled struts 312 is shown to be circumferentially arranged in a generally zigzagged pattern.

[0208] In some examples, the interconnected struts 310 can optionally further comprise horizontal struts 320 that extend between adjacent cells 328 of a cell row 330. The horizontal struts 320 can extend in a circumferential direction and also be referred to as circumferentially extending struts 320. The horizontal struts 320 can connect angled struts of two adjacent rungs of angled struts of the frame 302 to one another. Horizontal strut 320 can define, or be part of, intermediate junctions 338 interconnecting adjacent cells or struts.

[0209] As mentioned above, while three rows 330 of cells 328 defined between five rungs 314 of angled struts 312 are illustrated, it is to be understood that an exemplary prosthetic valve 300 can include any other number of cell rows 330 and strut rungs 314.

[0210] In some examples, the prosthetic valve 200 can optionally include an inner skirt 346 secured to an inner surface of the frame 302. In some examples, the prosthetic valve 300 can include an outer skirt 348 mounted on an outer surface of the frame 302. Any of the inner skirt 346 or outer skirt 348 can be similar to any example described above for an inner skirt 146 or outer skirt 148, respectively, of prosthetic valve 100.

[0211] In some examples, an exemplary valvular structure 50bcan be optionally mounted in frame 302 of prosthetic valve 300, forming commissure 80bhaving integral commissure folds 74 and pockets 84.

[0212] Fig. 12 illustrates a commissure 80bwhich can be representative of a first commissure 80bI coupled to the frame 302. A first commissure 80bI of prosthetic valve 300 can be formed by extending an integral commissure fold 74 of a valvular structure 50bradially outwards through an outflow cell 2280, and extending a pocket 84 circumferentially aligned with the integral commissure fold 74 radially outwards through an axially- adjacent cell 228 which is distal to the outflow cell 2280, such as an axially-adjacent cell 128S2 of the second subsequent cell row 130S2.

[0213] A wedge member 90 is then inserted through the channel 82 of the integral commissure fold 74 towards and into pocket 84, such that the portion of the wedge member 90 extending across the intermediate slit 70 is also supported against the outer surface of the frame 302, so as to secure the commissure 80bI to the frame 302.

[0214] While the commissure 80billustrated in Fig. 12 may be exemplary of a first commissure 80bI of prosthetic valve 300, it is to be understood that a second commissure 80bS can be similarly formed for prosthetic valve 300 by extending the tabs 76a, 76b of a valvular structure 50bradially outwards through an outflow cell 2280, and forming a pocket 84 aligned with the joined tabs 76 by extending portions of the side edges 42a, 42b extending distally from the side slits 72 radially outwards through an axially-adjacent cell 228 which is distal to the outflow cell 2280, such as an axially-adjacent cell 128S2 of the second subsequent cell row 130S2.

[0215] The portions of the tabs 76a, 76b extending out of the outflow cell 2280 are wrapped over an upper portion of the wedge member 90 positioned in front (e.g., radially outwards from) the outflow cell 2280, and portions of the side edges 42a, 42b extending out of the corresponding axially-adjacent cell 228 (e.g., cell 228S2 of the second subsequent cell row 230S2) are similarly wrapped over a lower portion of the wedge member 90 positioned in front of the axially-adjacent cell 228 (e.g., radially outwards from, and along at least an upper part of, the cell 228S2). In this manner, the portion of the wedge member 90 extending across the side slits 72 is also supported against the outer surface of the frame 302, so as to secure commissure 80bS to the frame 302.

[0216] In some examples, an upper end portion 81 of a commissure 80 of prosthetic valve 300 extends over an outflow apex 332 and / or portions of adjacent outflow angled struts 3120 converging to the outflow apex 332. The upper end portion 81 of a commissure 80 can include upper portions of the wedge member 90 and integral commissure fold 74 or tabs 76 wrapped thereover. In some examples, the total width of the wedge member 90 and the integral commissure fold 74 or tabs 76 surrounding it, at the upper end portion 81 of the commissure 80, greater than the width of the outflow apex 332 and / or portions of outflow angled struts3120 against which the upper end portion 81 is positioned, so as to provide additional support of the commissure 80, at its upper end portion 81, against the frame 302.

[0217] Optionally, the height of the integral commissure folds 74 and tabs 76 of a valvular structure 50b, defined by the distance of the intermediate slits 70 and side slits 72 from the level of the free edges 58, can generally match the height of opening of the outflow cells 2280. The height (in the axial direction) of the intermediate slit 70 and side slits 72 can be set to accommodate the junction 338c connecting the outflow cell 2280 with the corresponding axially-adjacent cell 328S2.

[0218] One or more sutures or other appropriate couplers (not shown) can be employed to attached different portion of a commissure 80 of prosthetic valve 300 to each other, in a similar manner to that described above with respect to the first and second commissures of prosthetic valve 100. In some examples, an upper end portion 81 of the commissure 80 can be secured, such as by one or more sutures, to the outflow end 304 of the frame 302, such as to the corresponding outflow apex 332 and / or portions of outflow angled struts 3120.

[0219] While an exemplary valvular structure 50bmounted in a frame 302 and forming commissures 80bis described above and illustrated in Figs. 11-12, it is to be understood that in some examples, a prosthetic valve 300 can include an exemplary valvular structure 50dmounted inside its frame 302 and forming commissures 80din a similar manner to that described above for prosthetic valve 200dwith respect to Figs. 10A-10B, mutatis mutandis. For example, an upper integral commissure fold 74U and / or upper tabs 76U of a valvular structure 50dcan extend radially outwards through an outflow cell 2280 of the frame 302, in a similar manner to that described above for an integral commissure fold 74 and / or tabs 76 of a valvular structure 50b, and lower integral commissure fold 74L and / or lower tabs 76L of a valvular structure 50dcan extend radially outwards through a corresponding axially-adjacent cell 228S2, instead of pocket 84, with a wedge members 90 extending through corresponding upper and lower channels 82U, 82L and across a junction 338c disposed therebetween, to form a commissure 80dof a prosthetic valve 300.

[0220] Outflow cells 3300 and axially-adjacent cells 330S2 to which first commissures 801 are coupled, can also be referred to, throughout the specification and the claims, as first outflow cells 3300 and first axially-adjacent cells 330S2. Similarly, outflow cells 3300 and axially- adjacent cells 330S2 to which second commissures 80S are coupled, can also be referred to, throughout the specification and the claims, as second outflow cells 3300 and second axially- adjacent cells 330S2.Some Examples of the Disclosed Implementations

[0221] 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.

[0222] Example 1. A prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration; and a valvular structure coupled to the frame and comprising: a plurality of integrally formed leaflets configured to regulate flow through the prosthetic valve; and at least one integral commissure fold continuously extending between two adjacent leaflets, the integral commissure fold defined proximal to an intermediate slit of the valvular structure and extending radially outwards through a first window opening of the frame, forming a first commissure coupled to the frame; wherein the valvular structure is a one-piece material.

[0223] Example 2. The prosthetic valve of any example herein, particularly of example 1, wherein the first commissure further comprises a first wedge member extending through a channel of the integral commissure fold.

[0224] Example 3. The prosthetic valve of any example herein, particularly of example 2, wherein the first wedge member is positioned radially outwards to the first window opening.

[0225] Example 4. The prosthetic valve of any example herein, particularly of any one of examples 2-3, wherein a total width of the first commissure is greater than a width of the first window opening.

[0226] Example 5. The prosthetic valve of any example herein, particularly of any one of examples 2-4, wherein the valvular structure is formed from a patch comprising two opposing side edges attached to each other to form a cylindrical configuration of the valvular structure.

[0227] Example 6. The prosthetic valve of any example herein, particularly of example 5, wherein the valvular structure further comprises two tabs extending from the opposing side edges.

[0228] The prosthetic valve of claim 6, wherein the tabs extend radially outwards through a second window opening of the frame, forming a second commissure coupled to the frame.

[0229] Example 8. The prosthetic valve of any example herein, particularly of example 7, wherein the tabs are wrapped around a second wedge member of the second commissure.

[0230] Example 9. The prosthetic valve of any example herein, particularly of example 8, wherein the second wedge member is positioned radially outwards to the second window opening.

[0231] Example 10. The prosthetic valve of any example herein, particularly of any one of examples 7-8, wherein a total width of the second commissure is greater than a width of the second window opening.

[0232] Example 11. The prosthetic valve of any example herein, particularly of any one of examples 1-10, wherein the first commissure terminates proximal to outflow apices of the frame.

[0233] Example 12. The prosthetic valve of any example herein, particularly of any one of examples 2-10, wherein the frame comprises an outflow rung of angled stmts, a first subsequent rung of angled stmts, and a plurality of axial frame members extending between the outflow mng and the first subsequent mng.

[0234] Example 13. The prosthetic valve of any example herein, particularly of example 12, wherein the plurality of axial frame members are parallel to each other.

[0235] Example 14. The prosthetic valve of any example herein, particularly of any one of examples 12-13, wherein the plurality of axial frame members comprises a plurality of axial post stmts and a plurality of axial support members.

[0236] Example 15. The prosthetic valve of any example herein, particularly of example 14, wherein the frame further comprises a plurality commissure posts extending proximally from the axial post stmts, wherein at least one of the commissure posts is a first commissure post comprising the first window.

[0237] Example 16. The prosthetic valve of any example herein, particularly of example 15, wherein the first commissure is coupled to the corresponding first commissure post.

[0238] Example 17. The prosthetic valve of any example herein, particularly of any one of examples 7-10, wherein the frame comprises an outflow mng of angled stmts defining outflow apices of the frame, and a second commissure post extending proximally from the outflow mng, the second commissure post defining the second window.

[0239] Example 18. The prosthetic valve of any example herein, particularly of example 17, wherein the second commissure is coupled to the second commissure post.

[0240] Example 19. The prosthetic valve of any example herein, particularly of any one of examples 12-13, wherein the plurality of axial frame members comprises a plurality of axial stmts and a plurality of commissure support members.

[0241] Example 20. The prosthetic valve of any example herein, particularly of example 19, wherein at least one of the commissure support members is a first commissure support member defining the first window between sidewalls of the first commissure support member.

[0242] Example 21. The prosthetic valve of any example herein, particularly of example 20, wherein the first commissure is coupled to the corresponding first commissure support member.

[0243] Example 22. The prosthetic valve of any example herein, particularly of any one of examples 20-21, wherein the valvular structure further comprises a pocket distal to the intermediate slit, the pocket extending radially outwards through an axially-adjacent cell of the frame, which is distal to the first commissure support member.

[0244] Example 23. The prosthetic valve of any example herein, particularly of example 22, wherein the first wedge member extends from the integral commissure fold, across a junction connecting the first commissure support member with the axially-adjacent cell, into the pocket.

[0245] Example 24. The prosthetic valve of any example herein, particularly of any one of examples 20-21, wherein the first commissure support member further comprises a crossbar extending between the sidewalls, wherein the first window opening is a first upper window opening extending proximally from the crossbar, and wherein the first commissure support member further comprises a first lower window opening extending distally from the crossbar.

[0246] Example 25. The prosthetic valve of any example herein, particularly of example 24, wherein the valvular structure further comprises a pocket distal to the intermediate slit, the pocket extending radially outwards through the first lower window opening.

[0247] Example 26. The prosthetic valve of any example herein, particularly of example 25, wherein the first wedge member extends from the integral commissure fold, across the crossbar, into the pocket.

[0248] Example 27. The prosthetic valve of any example herein, particularly of example 24, wherein the integral commissure fold extending through the first upper window opening is an upper integral commissure fold, and wherein the valvular structure further comprises a lower integral commissure fold extending radially outwards through the first lower window opening.

[0249] Example 28. The prosthetic valve of any example herein, particularly of example 27, wherein the intermediate slit at which the upper integral commissure fold terminates is an upper intermediate slit, and wherein the lower integral commissure fold axially extends between the upper intermediate slit and a lower intermediate slit of the valvular structure.

[0250] Example 29. The prosthetic valve of any example herein, particularly of example 28, wherein the first wedge member extends from the upper integral commissure fold, across the crossbar, into through a channel of the lower integral commissure fold.

[0251] Example 30. The prosthetic valve of any example herein, particularly of any one of examples 24-29, wherein the first upper window opening is open towards an outflow end of the frame, and the first lower window opening is open towards an axially- adjacent cell of frame.

[0252] Example 31. The prosthetic valve of any example herein, particularly of any one of examples 27-29, wherein the first commissure support member further comprises an upper lateral strut portion proximal to the crossbar, and a lower lateral strut portion distal to the crossbar.

[0253] Example 32. The prosthetic valve of any example herein, particularly of any one of examples 8-10, wherein the frame comprises a plurality of axial frame members disposed between adjacent outflow cells of the frame, the plurality of axial frame members comprising a plurality of axial struts and a plurality of commissure support members.

[0254] Example 33. The prosthetic valve of any example herein, particularly of example 32, wherein at least one of the commissure support members is a second commissure support member defining the second window between sidewalls of the second commissure support member.

[0255] Example 34. The prosthetic valve of any example herein, particularly of example 33, wherein the second commissure is coupled to the second commissure support member.

[0256] Example 35. The prosthetic valve of any example herein, particularly of any one of examples 33-34, wherein the second commissure support member further comprises a crossbar extending between the sidewalls, wherein the second window opening is a second upper window opening extending proximally from the crossbar, and wherein the second commissure support member further comprises a second lower window opening extending distally from the crossbar.

[0257] Example 36. The prosthetic valve of any example herein, particularly of example 35, wherein the tabs extending through the second upper window opening are upper tabs, and wherein the valvular structure further comprises two lower tabs extending from the opposing side edges and radially outwards through the second lower window opening.

[0258] Example 37. The prosthetic valve of any example herein, particularly of example 36, wherein the lower tabs are wrapped around the second wedge member.

[0259] Example 38. The prosthetic valve of any example herein, particularly of example 37, wherein the second wedge member extends across the crossbar between the upper tabs and the lower tabs.

[0260] Example 39. The prosthetic valve of any example herein, particularly of any one of examples 35-38, wherein the wherein the second upper window opening is open towards anoutflow end of the frame, and the second lower window opening is open towards an axially- adjacent cell of frame.

[0261] Example 40. The prosthetic valve of any example herein, particularly of any one of examples 35-38, wherein the second commissure support member further comprises an upper lateral strut portion proximal to the crossbar, and a lower lateral strut portion distal to the crossbar.

[0262] Example 41. The prosthetic valve of any example herein, particularly of any one of examples 1-40, wherein the valvular structure comprises tissue.

[0263] Example 42. The prosthetic valve of any example herein, particularly of example 41, wherein the tissue comprises pericardium.

[0264] Example 43. The prosthetic valve of any example herein, particularly of any one of examples 1-42, wherein each leaflet further comprises a cusp line coupled to the frame, a free edge, and a leaflet belly extending between the cusp line and the free edge.

[0265] Example 44. The prosthetic valve of any example herein, particularly of example 43, wherein the leaflet belly is not flattenable.

[0266] Example 45. A prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame comprising an outflow cell row, a first subsequent cell row, and a second subsequent cell row; and a valvular structure coupled to the frame and comprising: a plurality of integrally formed leaflets configured to regulate flow through the prosthetic valve; and at least one integral commissure fold continuously extending between two adjacent leaflets, the integral commissure fold defined proximal to an intermediate slit of the valvular structure and extending radially outwards through an outflow cell of the outflow cell row, forming a commissure coupled to the frame; wherein the valvular structure is a one-piece material.

[0267] Example 46. The prosthetic valve of any example herein, particularly of example 45, wherein the commissure further comprises a wedge member extending through a channel of the integral commissure fold.

[0268] Example 47. The prosthetic valve of any example herein, particularly of example 46, wherein the wedge member is positioned radially outwards to the cell of the outflow cell row.

[0269] Example 48. The prosthetic valve of any example herein, particularly of any one of examples 46-47, wherein the valvular structure further comprises a pocket distal to the intermediate slit, the pocket extending radially outwards through an axially-adjacent cell of the second subsequent cell row.

[0270] Example 49. The prosthetic valve of any example herein, particularly of example 48, wherein the wedge member extends from the integral commissure fold, across a junction connecting the outflow cell with the axially-adjacent cell, into the pocket.

[0271] Example 50. The prosthetic valve of any example herein, particularly of any one of examples 46-47, wherein the integral commissure fold extending through the outflow cell is an upper integral commissure fold, and wherein the valvular structure further comprises a lower integral commissure fold extending radially outwards through an axially-adjacent cell of the second subsequent cell row.

[0272] Example 51. The prosthetic valve of any example herein, particularly of example 50, wherein the intermediate slit at which the upper integral commissure fold terminates is an upper intermediate slit, and wherein the lower integral commissure fold axially extends between the upper intermediate slit and a lower intermediate slit of the valvular structure.

[0273] Example 52. The prosthetic valve of any example herein, particularly of example 51, wherein the wedge member extends from the upper integral commissure fold, across a junction connecting the outflow cell with the axially-adjacent cell, into through a channel of the lower integral commissure fold.

[0274] Example 53. The prosthetic valve of any example herein, particularly of any one of examples 45-52, wherein the valvular structure comprises tissue.

[0275] Example 54. The prosthetic valve of any example herein, particularly of example 53, wherein the tissue comprises pericardium.

[0276] Example 55. The prosthetic valve of any example herein, particularly of any one of examples 45-54, wherein each leaflet further comprises a cusp line coupled to the frame, a free edge, and a leaflet belly extending between the cusp line and the free edge.

[0277] Example 56. The prosthetic valve of any example herein, particularly of example 55, wherein the leaflet belly is not flattenable.

[0278] 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.

[0279] 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 andshould not be taken as limiting the scope. Rather, the scope is defined by the following claims.We therefore claim all that comes within the scope and spirit of these claims.

Claims

CLAIMS1. A prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration; and a valvular structure coupled to the frame and comprising: a plurality of integrally formed leaflets configured to regulate flow through the prosthetic valve; and at least one integral commissure fold continuously extending between two adjacent leaflets, the integral commissure fold defined proximal to an intermediate slit of the valvular structure and extending radially outwards through a first window opening of the frame, forming a first commissure coupled to the frame; wherein the valvular structure is a one-piece material.

2. The prosthetic valve of claim 1, wherein the first commissure further comprises a first wedge member extending through a channel of the integral commissure fold.

3. The prosthetic valve of claim 2, wherein a total width of the first commissure is greater than a width of the first window opening.

4. The prosthetic valve of any one of claims 2-3, wherein the valvular structure is formed from a patch comprising two opposing side edges attached to each other to form a cylindrical configuration of the valvular structure.

5. The prosthetic valve of claim 4, wherein the valvular structure further comprises two tabs extending from the opposing side edges.

6. The prosthetic valve of claim 5, wherein the tabs extend radially outwards through a second window opening of the frame, forming a second commissure coupled to the frame.

7. The prosthetic valve of claim 6, wherein the tabs are wrapped around a second wedge member of the second commissure.

8. The prosthetic valve of any one of claims 6-7, wherein a total width of the second commissure is greater than a width of the second window opening.

9. The prosthetic valve of any one of claims 2-8, wherein the frame comprises an outflow rung of angled struts, a first subsequent rung of angled struts, and aplurality of axial frame members extending between the outflow rung and the first subsequent rung.

10. The prosthetic valve of claim 9, wherein the plurality of axial frame members comprises a plurality of axial struts and a plurality of commissure support members.

11. The prosthetic valve of claim 10, wherein at least one of the commissure support members is a first commissure support member defining the first window between sidewalls of the first commissure support member.

12. The prosthetic valve of claim 11, wherein the valvular structure further comprises a pocket distal to the intermediate slit, the pocket extending radially outwards through an axially- adjacent cell of the frame, which is distal to the first commissure support member.

13. The prosthetic valve of claim 12, wherein the first wedge member extends from the integral commissure fold, across a junction connecting the first commissure support member with the axially-adjacent cell, into the pocket.

14. A prosthetic valve comprising: a frame movable between a radially compressed configuration and a radially expanded configuration, the frame comprising an outflow cell row, a first subsequent cell row, and a second subsequent cell row; and a valvular structure coupled to the frame and comprising: a plurality of integrally formed leaflets configured to regulate flow through the prosthetic valve; and at least one integral commissure fold continuously extending between two adjacent leaflets, the integral commissure fold defined proximal to an intermediate slit of the valvular structure and extending radially outwards through an outflow cell of the outflow cell row, forming a commissure coupled to the frame; wherein the valvular structure is a one-piece material.

15. The prosthetic valve of claim 14, wherein the commissure further comprises a wedge member extending through a channel of the integral commissure fold.

16. The prosthetic valve of claim 15, wherein the valvular structure further comprises a pocket distal to the intermediate slit, the pocket extending radially outwards through an axially-adjacent cell of the second subsequent cell row.

17. The prosthetic valve of claim 16, wherein the wedge member extends from the integral commissure fold, across a junction connecting the outflow cell with the axially-adjacent cell, into the pocket.

18. The prosthetic valve of claim 15, wherein the integral commissure fold extending through the outflow cell is an upper integral commissure fold, and wherein the valvular structure further comprises a lower integral commissure fold extending radially outwards through an axially-adjacent cell of the second subsequent cell row.

19. The prosthetic valve of claim 18, wherein the intermediate slit at which the upper integral commissure fold terminates is an upper intermediate slit, and wherein the lower integral commissure fold axially extends between the upper intermediate slit and a lower intermediate slit of the valvular structure.

20. The prosthetic valve of claim 19, wherein the wedge member extends from the upper integral commissure fold, across a junction connecting the outflow cell with the axially-adjacent cell, into through a channel of the lower integral commissure fold.

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