Prosthetic valves having flexible polymeric structures coupled to frames thereof

Abstract

The present disclosure relates to prosthetic valves comprising flexible structures coupled to frames thereof. In an example, a prosthetic valve comprises a frame configured to transition between a radially expanded and a crimped state, and one or more flexible polymeric structures. A frame-facing surface of at least one of the flexible polymeric structures is interfacing at an interface region with a portion of an inner surface or an outer surface of at least one strut of the frame to which the flexible polymeric structure is coupled. At least one of the flexible polymeric structures and the at least one strut can define a textured surface formed along at least a portion of the interface region.

Description

THVFN-23757WOOIPROSTHETIC VALVES HAVING FLEXIBLE POLYMERIC STRUCTURES COUPLED TO FRAMES THEREOF CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Patent Application No. 63 / 742,561, filed January 7, 2025, the entire disclosure which is incorporated by reference for all purposes.FIELD

[0002] The present disclosure relates to prosthetic devices, and in particular, to prosthetic valves having flexible polymeric structures designed to be coupled to frames thereof.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. Artificial valves can remain substantially fully effective in the body for up to about 15 years, before beginning to malfunction. Malfunctioning artificial valves can be replaced, but this is a difficult and highly invasive procedure, with relatively high risk to the patient.

[0004] Most expandable prosthetic valves comprise a cylindrical metal frame and prosthetic leaflets mounted inside the frame. The prosthetic leaflets, otherwise referred to as valvular structure, are designed to imitate the native heart valves. Although having some obvious benefits, artificial leaflets derived from organic tissue suffer several drawbacks, not least of which is relatively swift degradation. These drawbacks have led to a rising trend of alternative synthetic valvular structures, having higher durability and quite good bio-compatibility. The synthetic valvular structures are usually formed from flexible polymeric material, which allows the valves to open and close (during systole and diastole, for example), in order to regulate a flow of blood through the prosthetic heart valve.SUMMARY

[0005] The present disclosure is directed towards prosthetic valves including a textured portion at an interfacing region defined between struts of the frame and a flexible polymeric structure suturelessly coupled thereto.

[0006] In one of its basic configurations, a prosthetic valve comprises a frame and at least one flexible polymeric structure suturelessly coupled to the frame. This basic configuration can preferably be provided with any one or more of the features describedTHVFN-23757WOOIelsewhere herein, in particular with those of the examples described hereafter. However, it should be understood that the basic configuration can preferably also be provided with any one or more of the features shown in the figures and / or described in conjunction with the figures, either in addition to or alternatively to the features of the examples described hereafter.

[0007] In some examples, the frame is configured to transition between a radially expanded and a crimped state.

[0008] In some examples, the frame comprises a plurality of intersecting struts.

[0009] In some examples, the flexible polymeric structure is suturelessly coupled to the frame by a coupling portion that encapsulates at least a portion of the plurality of struts.

[0010] In some examples, the at least one flexible polymeric structure is coupled to the frame by a coupling portion that encapsulates at least a portion of the plurality of struts.

[0011] In some examples, a portion of a frame-facing surface, along a portion of the at least one flexible polymeric structure which is coupled to the corresponding plurality of encapsulated struts, is interfacing at an interface region with a surface of the encapsulated struts facing the corresponding portion of the flexible polymeric structure coupled thereto.

[0012] In some examples, at least one of the flexible polymeric structures and at least one strut of the frame comprises the textured surface formed along at least a portion of the interface region.

[0013] In some examples, the textured surface is configured to limit relative movement between the at least one flexible polymeric structure and the corresponding struts coupled thereto along the interface region.

[0014] In some examples, the textured surface is configured to enhance friction between the at least one flexible polymeric structure and the corresponding struts coupled thereto along the interface region.

[0015] In some examples, the textured surface is configured to enhance adhesive forces between the at least one flexible polymeric structure and the corresponding struts coupled thereto along the interface region.

[0016] In some examples, the at least one flexible polymeric structure comprises at least one of: a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve; an inner skirt mounted on the inner surface of the frame; and an outer skirt mounted on the outer surface of the frame.

[0017] In some examples, the at least one flexible polymeric structure defining the interface region comprises the valvular structure.

[0018] In some examples, the portion of the flexible polymeric structure coupled to the frame by the coupling portion comprises cusp end portions of the leaflets.

[0019] In some examples, the at least one flexible polymeric structure defining the interface region comprises the inner skirt, wherein the frame-facing surface of the inner skirt is an outer surface of the inner skirt, and wherein the inner skirt comprises the textured surface formed on its outer surface.

[0020] In some examples, the at least one flexible polymeric structure comprises the outer skirt, wherein the frame-facing surface of the outer skirt is an inner surface of the outer skirt, and wherein the outer skirt comprises the textured surface on its inner surface.

[0021] In some examples, the textured surface comprises peak regions and trough regions.

[0022] In some examples, the peak regions extend at an angle relative to a plane of a non-textured surface bordering with the textured surface.

[0023] In some examples, a prosthetic valve can include any of the features recited in Examples 1—29 below.

[0024] 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

[0025] 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.THVFN-23757WOOI

[0026] In the Figures:

[0027] Fig. 1A is a perspective side view of an exemplary prosthetic valve.

[0028] Fig. 1B is a perspective side view of the frame of the prosthetic valve of Fig. 1A.

[0029] Fig. 2 is a perspective view of an exemplary valvular structure comprising three leaflets.

[0030] Fig. 3 is a perspective side view of an exemplary prosthetic valve in which the valvular structure is sutured to the frame thereof.

[0031] Fig. 4 shows an exemplary delivery apparatus carrying an exemplary prosthetic valve.

[0032] Fig. 5A is a perspective view of an exemplary prosthetic valve including a valvular structure coupled to the frame by [a coupling portion formed from] an adhesive composition.

[0033] Fig. 5B is a perspective side view of a frame including commissure support members devoid of commissure window openings.

[0034] Fig. 6 schematically shows a single polymeric leaflet including struts coupled thereto by a coupling portion.

[0035] Fig- ?A isacross-sectional view of a strut overlying a leaflet, in preparation to having a polymeric solution applied thereto.

[0036] Fig. 7B is a cross-sectional view of the strut coupled to the leaflet of Fig. 7 A, following application of the polymeric solution which forms an adhesive composition.

[0037] Fig. 8A is a perspective side view of a single polymeric leaflet including a textured portion.

[0038] Fig. 8B is a magnified view of a portion of the textured portion of Fig. 8A.

[0039] Fig. 9 shows an exemplary forming of a textured portion of a leaflet using a toothed instrument.

[0040] Fig. 10A is a perspective view of a frame including a textured portion along a scalloped line on the inner surface thereof.

[0041] Fig. 10B is a magnified view of a portion of the textured portion of Fig. 10A.

[0042] Fig. nA is a cross-sectional view of an interface region of a flexible polymeric structure and a strut including a textured portion protruding skewedly from the surface of the flexible polymeric structure.

[0043] Fig- nB is a cross-sectional view of an interface region similar to Fig. 11A, including a textured portion protruding perpendicularly from the strut surface.

[0044] Fig. 12A shows a pre-assembled flattened view of an exemplary outer skirt including a textured portion on the inner surface thereof shaped to correspond to struts of a frame.

[0045] Fig. 12B shows the outer skirt of Fig. 12A, rolled to a cylindrical shape.

[0046] Fig. 13 is a perspective view of a frame including a textured portion on the outer surface thereof [corresponding to the height of the outer skirt].

[0047] Fig. 14A shows a pre-assembled flattened view of an exemplary inner skirt including a textured portion on the outer surface thereof shaped to correspond to struts of a frame.

[0048] Fig. 14B shows the inner skirt of Fig. 14A, rolled to a cylindrical shape.

[0049] Fig. 15 is a perspective view of a frame including a textured portion on the inner surface thereof [corresponding to the height of the inner skirt].DETAILED DESCRIPTION

[0050] 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 anyway. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and subcombinations 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.

[0051] 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 theTHVFN-23757WOOIdisclosed 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 ordinaiy skill in the art.

[0052] 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.

[0053] 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”.

[0054] Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as “inner,” “outer,” “upper,” “lower,” “inside,” “outside,” “top,” “bottom,” “interior,” “exterior,” “left,” right,” and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated examples. Such terms are not, however, intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, an “upper” part can become a “lower” part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same.

[0055] 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.

[0056] The terms “proximal” and “distal” are defined relative to the use position of a delivery apparatus. In general, the end of the delivery apparatus closest to the user of the apparatus is the proximal end, and the end of the delivery apparatus farthest from theuser (e.g., the end that is inserted into a patient’s body) is the distal end. The term “proximal” when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the proximal end of the delivery apparatus. The term “distal” when used with two spatially separated positions or parts of an object can be understood to mean closer to or oriented towards the distal end of the delivery apparatus. The terms “longitudinal” and “axial” are interchangeable, and refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0057] 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.

[0058] Figs. 1A-1B illustrate a prosthetic valve 10 according to one example. The term “prosthetic valve,” as used herein, refers to any type of a prosthetic valve deliverable to a patient’s target site over a catheter, which is radially expandable and compressible between a radially compressed, or crimped, state, and a radially expanded state. Thus, the prosthetic valves can optionally be crimped on or retained by an implant delivery apparatus 252 (see Fig. 4) in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site. The expanded state may include a range of diameters to which the valve may expand, between the compressed state and a maximal diameter reached at a fully expanded state. Thus, a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state.

[0059] A prosthetic valve of the current disclosure (e.g., prosthetic valve 10, too) may include any prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve. The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve), or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. TheTHVFN-23757WOOIdisclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0060] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Patent No. 10,363,130, which is incorporated by reference herein. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in US Publication No. 2022 / 0079749, which is incorporated herein by reference. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Patent No. 11,291,540, which is incorporated herein by reference.

[0061] It is to be understood that any prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses. Balloon expandable valves generally involve a procedure of inflating a balloon within a prosthetic valve, thereby expanding the prosthetic valve within the desired implantation site. Once the valve is sufficiently expanded, the balloon is deflated and retrieved along with a delivery apparatus 252 (see Fig. 4). 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.

[0062] The prosthetic valve 10 comprises a frame 106 movable between a radially compressed state and a radially expanded state, and a valvular structure mounted within the frame 106. The frame extends between an inflow end 104 and an outflow end 102, and defines a central longitudinal axis extending in a direction from the inflow end 104 to the outflow end 102. In some instances, the inflow end 104 is the distal end of the frame 106, and the outflow end 102 is the proximal end of the frame 106. Alternatively, depending for example on the delivery approach of the valve, the inflow end can be the proximal end of the frame, and the outflow end can be the distal end of the frame. Fig. 1A is a perspective view of an exemplary prosthetic valve 10 that can optionally include an inner skirt 180 disposed within an inner surface 118 of the frame 106, an outer skirt 170 disposed around an outer surface 116 of the frame 106, and a valvular structure 50 mounted inside the frame 106, optionally connected to the inner skirt 180. Fig. 1B is a perspective view of the frame 106 of the prosthetic valve 10 of Fig. 1A.

[0063] The term “proximal,” as used herein, generally refers to a position, direction, or portion of a device or a component of a device, which is closer to the user (for example, during an implantation procedure) and further away from the implantation site.

[0064] The term “distal,” as used herein, generally refers to a position, direction, or portion of a device or a component of a device, which is further away from the user and closer to the implantation site.

[0065] 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.

[0066] The term “inflow,” as used herein, refers to a region of the prosthetic valve through which the blood flows into the prosthetic valve.

[0067] 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.

[0068] The terms “longitudinal” and “axial,” as used herein, refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0069] The frame 106 can be made of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol). When constructed of a plastically-expandable material, the frame 106 (and thus a valve 10, too disclosed herein) can be crimped to a radially compressed state on a delivery catheter (e.g., balloon catheter 260 shown in Fig.4) and then expanded inside a patient by an inflatable balloon (e.g., balloon 262 shown in Fig. 4) or equivalent expansion mechanism. Whenconstructed of a self-expandable material, the frame 106 (and thus the valve 10, too) 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.

[0070] Suitable plastically-expandable materials that can optionally be used to form the frames disclosed herein (e.g., the frame 106) include metal alloys, polymers, or combinations thereof. Example metal alloys can optionally comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 106 comprises stainless steel. In some examples, the frame 106 comprises cobalt-chromium. In some examples, the frame 106 comprises nickel-cobalt-chromium. In some examples, the frame 106 comprises a nickel-cobalt - chromium-molybdenum alloy, such as MP35N™ (tradename of SPS technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0071] In the example illustrated in Figs. 1A-1B, the frame 106 is an annular, stent-like structure comprising a plurality of intersecting struts 108 which form multiple rows 130 of cells 126 between the outflow end 102 and the inflow end 104 of the frame 106. The frame 106 defines a frame inner surface 118 facing the longitudinal central axis of the frame, and an opposite frame outer surface 116 facing away from the central axis of the frame, for example facing the surrounding anatomy, including annular and blood vessel walls, when implanted in a patient’s body.

[0072] In this application, the term “strut” 108 encompasses vertical struts, angled or curved struts, support posts, commissure windows, and any similar structures described by U.S. Pat. Nos. 7,993,394 and 9,393,110, which are incorporated herein by reference. A strut 108 may be any elongated member or portion of the frame 106. The frame 106 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 104 to the outflow end 102 as shown, or the frame can vary in diameter along the height of the frame, as disclosed in US Pat. No. 9,155,619, which is incorporated herein by reference.

[0073] The interconnected struts 108 include a plurality of angled struts 110 arranged in a plurality of circumferentially extending rungs 112 of angled struts 108, with the strut rungs 112 being arrayed along the length of the frame 106 between the outflow end 102 and the inflow end 104. Struts 108 of the frame 106 can optionally further include a plurality of axial frame members 114. The term “axial frame member” refers to a strut or a component of the frame 106 that generally extends in an axial direction, while the termTHVFN-23757WOOI“angled strut” generally refers to a strut that can extend at an angle relative to an axial line intersecting therewith along a plane defined by the frame 106. It is to be understood that the term “angled strut” encompasses both linear angled struts and curved struts.

[0074] Two or more struts 108 can intersect at junctions 132, which can be equally or unequally spaced apart from each other. The frame 106 can further comprise a plurality of outflow apices 134 at the outflow end 102 of the frame, and a plurality of inflow apices 136 at the inflow end 104 of the frame. The struts 108 may be pivotable or bendable relative to each other, so as to permit frame expansion or compression. For example, the frame 106 can be optionally formed from a single piece of material, such as a metal tube, via various processes such as, but not limited to, laser cutting, electroforming, and / or physical vapor deposition, while retaining the ability to collapse / expand radially in the absence of hinges and like.

[0075] The valvular structure 50 can comprise a plurality of leaflets 52 (e.g., three leaflets), positioned at least partially within the frame 106, and configured to regulate flow of blood through the prosthetic valve 10 from the inflow end 104 to the outflow end 102. While three leaflets 52 arranged to collapse in a tricuspid arrangement are shown, explicitly in the example illustrated in Fig 2 for example, it will be clear that a prosthetic valve 10 can include any other number of leaflets 52. Adjacent leaflets 52 can be arranged together to form commissures 192 that are coupled (directly or indirectly) to respective portions of the frame 106, thereby securing at least a portion of the valvular structure 50 to the frame 106.

[0076] Fig. 2 shows a perspective view of a collapsed valvular structure 50, comprising three exemplary leaflets 52. Each leaflet 52 can define opposing outflow side portions 159, extending between the cusp end portions 156 and the free edge portion 154. In some examples, outflow side portions 159 serve as commissure attachment members, which can be optionally in the form of tabs 160 as shown, for example, in Fig. 2. Optionally, each tab 160 can be secured to an adjacent tab 160 of an adjacent leaflet 52 to form a commissure 192 that is secured to the frame 106.

[0077] Each leaflet 52 can further include a free edge portion 154 on a portion of the leaflet 52 between the two tabs 160 and closest to the outflow end 102 of the frame 106, and a cusp end portion 156 extending between the two tabs 160 opposite to the free edge portion 154. In some examples, the cusp end portion 156 can optionally have an undulating, curved scalloped shape. A leaflet inflow end portion (not annotated) is defined as the distal-most portion of the leaflet 52 along the cusp end portion 156. In some examples, the leaflet inflow end portion can optionally be defined at the middle of the cusp end portion 156.

[0078] The leaflets 52 can optionally define a non-planar coaptation plane (not annotated) when the free edge portions 154 of the leaflets coapt or mate with each other to seal blood flow through the prosthetic valve 10. During diastole, the adjacent free edge portions 154 should coapt with each other to prevent retrograde blood from flowing between the free edge portions 154. During systole, the adjacent free edge portions 154 will separate from each other and allow antegrade blood to flow between free edge portions 154.

[0079] Leaflet 52 is further shown to include a leaflet body 158, which is the movable and unattached part of the leaflet, defined between a lower cusp end portion 156 and the upper free edge portion 154. In some examples, the leaflet body 158 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.

[0080] In some examples, the leaflet 52 can comprise shaped tissue material. In some examples, a leaflet body 158 of leaflet 52 disclosed herein is not flattenable. The term “not flattenable,” as used herein, means that the leaflet body 158 cannot be flattened. That is to say, if an attempt is made to straighten out the curve of a free edge portion 154, the curve will not be able to be completely straightened such that leaflet body 158 becomes flat. This is in contrast to leaflets that are cut from a flat patch and are then attached (e.g., sutured) to a frame of a prosthetic valve, wherein upon removal of such leaflets from the frame they can be laid flat on a flattened surface, with their free edge portions being able to completely straighten in their free state. In some examples, a leaflet body 158 which is not flattenable defines a non-developable surface. Further details regarding leaflets or leaflet bellies thereof, which are three-dimensional or not flattenable, are described in International Application No. PCT / US2022 / 032303, and U.S. Provisional Application No. 63 / 587,399, each of which is incorporated herein by reference in its entirety.

[0081] Each leaflet 52 defines a first leaflet surface 162, which is an outwardly-facing surface along at least the leaflet body 158, oriented towards the inner surface 118 of the frame 106. When the prosthetic valve 10 includes an inner skirt 180, the first leaflet surface 162 is an outwardly-facing surface of the leaflet body 158, oriented towards the inner surface 185 (indicated, for example, in Fig. 14A) of the inner skirt 180. Each leaflet 52 further defines a leaflet second surface 164, which is an inwardly-facing surface along at least the leaflet body 158, oriented the central longitudinal axis CA of the frame. In some examples, the cusp end portion 156 of the leaflet 52 can be outwardly folded over itself in the radial direction, such that at least the first leaflet surface 162 is facing radiallyTHVFN-23757WOOIinward along the cusp end portion, and the second leaflet surface 164 forms an outwardly-facing surface of the cusp end portion 156.

[0082] The leaflets 52 can optionally be made from, in whole or part, biological material (e.g., pericardium), bio-compatible synthetic materials, or other such materials. Further details regarding transcatheter prosthetic heart valves, including the manner in which the valvular structure 50, 150 can be coupled to the frame 106 of the prosthetic valve 10, too, 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. In some examples, the leaflets are made from a synthetic polymeric material selected from the group consisting of ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, and PE.

[0083] Returning to Figures 1A-1B, the frame 106 includes an outflow cell row 13OO, an inflow cell row 130I, and optionally (but not necessarily) one or more subsequent cell rows 130S therebetween. In the example illustrated in Figs. 1A-1B, the frame 106 is shown to comprises four cell rows 130, each row comprising a plurality of cells 126 extending circumferentially such that each cell 126 is directly coupled to two circumferentially adjacent cells 126 on both sides thereof within the same row of cells. The term “cell,” as used herein, refers to a closed cell, having an enclosed perimeter defined by at least four struts 108. The outflow cell row 1300, disposed at the outflow end 102, comprises outflow cells 126O that are elongated in an axial direction (relative to the central longitudinal axis), compared to cells 126 in the remaining cell rows 130, which can include a first subsequent cell row 130S1, a second subsequent cell row 130S2, and the inflow cell row 130I.

[0084] In some examples, such as shown in Figs. 1A-1B, each cell row 130 comprises twelve cells 126. Thus, the frame 106 can be referred to as a twelve-cell frame. In other examples, the frame 106 can have a greater or fewer number of circumferentially extending cell rows 130 and / or a greater or fewer number of cells 126 in each cell row.

[0085] In some examples, cells 126 are coupled to adjacent cells 126 within the same row, such as within the outflow (or proximal-most) cell row 1300, via axial frame members 114. Axial frame members 114 include, in some examples, commissure support members 122 and non-commissural axial struts 120. A commissure support member 122 is configured to support a corresponding commissure 192 of the valvular structure 50. The axial frame members 114, including non-commissural axial struts 120 and commissure support members 122, can optionally be parallel to each other and / or to the central longitudinal axis of the frame 106.[oo86] In some examples, a commissure support member 122 can optionally comprise a commissure window opening 124 defined between two axially-extending commissure sidewalls. While commissure support members 122 that include commissure window openings 124 are illustrated and described herein, it is to be understood that a frame 106 can include other types of commissure support members configured to mount a commissure 192 in any other suitable manner, such as by supporting portions of the valvular structure 50, 150 that can be wrapped therearound, can include apertures through which sutures for attaching the commissures can be passed, and the like. The terms “non-commissural axial strut” and “axial strut,” as used herein, are interchangeable, and refer to an axial frame member configured to remain unattached to the valvular structure 50. That is to say, an axial strut 120 is not configured to mount a commissure, and may be devoid of a window opening 124.

[0087] The frame 106 includes an outflow rung 112O, an inflow rung 112I, and one or more subsequent rungs 112S therebetween, which can be also referred to as intermediate rungs. In the example illustrated in Figs. 1A-1B, the frame io6ais shown to comprise five rungs 112 of angled struts 110, including the outflow rung 112O of angled outflow struts noO which is closer to the outflow end 102 relative to other rungs of struts, a first subsequent rung 112S1 of angled struts 110S1 which is distal to the outflow rung 112O, a second subsequent rung 112S2 of angled struts 110S2 which is distal to the first subsequent rung 112S1, a third subsequent rung 112S3 of angled struts 110S3 which is distal to the second subsequent rung 112S2, and the inflow rung 112I, which includes angled inflow struts 110I that are closer to the inflow end 104 relative to other rungs of struts. It is to be understood that a frame 106 can optionally include less or more than five rungs.

[0088] One or more (for example, three, as shown in Figs. 1A— 1B) axial struts 120 can be positioned between, in the circumferential direction, two commissure support members 122. In some examples, each axial strut 120 can have a width that is larger than a width of the angled struts 110. As used herein, a “width” of a strut is measured between opposing locations on opposing surfaces of a strut that extend between the radially facing inner and outer surfaces of the strut (relative to the central axis). A “thickness” of a strut is measured between opposing locations on the radially facing inner and outer surfaces of a strut and is perpendicular to the width of the strut. In some examples, the width of the axial struts 120 is 50-200%, 75-150%, or at least 100% larger than (e.g., double) the width of the angled struts 110 of the frame 106.

[0089] By providing the axial struts 120 with the width that is greater than the width of other, angled struts 110 of the frame 106, a larger contact area is provided for when theleaflets 52 contact the wider axial struts 120 during systole, thereby distributing the stress and reducing the extent to which the leaflets may fold over the axial struts 120, radially outward through the outflow cells 126O. As a result, a long-term durability of the leaflets can be increased.

[0090] The outflow cells 126O of the outflow cell row 1300 of the exemplary frame 106 illustrated in Figs. 1A— 1B are shown to be generally hexagonal, each cell defined between two outflow angled struts noO of the outflow rung 112O, two angled struts 110S1 of the first subsequent rung 112S1, and two axial frame members 114 extending between the outflow rung 112O and the first subsequent rung 112S1. Cells of the first subsequent cell row 130S1, second subsequent cell row 130S2, and inflow cell row 130I, can be generally diamond-shaped cells, with the cells 126S1 of the first subsequent cell row 130S1 defined by two angled struts 110S1 of the first subsequent rung 112S1 and two angled struts 110S2 of the second subsequent rung 112S2, cells 126S2 of the second subsequent cell row 130S2 defined by two angled struts 110S2 of the second subsequent rung 112S2 and two angled struts 110S3 of the third subsequent rung 112S3, and inflow cells 126I of the inflow cell row 130I defined by two angled struts 110S3 of the third subsequent rung 112S3 and two angled struts 110I of the inflow rung 112I.

[0091] Each rung 112 of angled struts 110 is shown to be circumferentially arranged in a generally zig-zagged pattern. Each axial frame member 114 can have an outflow end portion at which the axial frame member 114 is linked to outflow angled struts noO of the outflow rung 112O, and an inflow end portion at which the axial frame member 114 is linked to angled struts 110S1 of the first subsequent rung 112S1.

[0092] As mentioned above, while three rows 130 of cells 126 defined between five rungs 112 of angled struts 110 are illustrated, it is to be understood that any exemplary prosthetic valve disclosed herein can include any other number of cell rows 130 and strut rungs 112.

[0093] In some examples, the prosthetic valve 10 can optionally include an inner skirt 180 secured to inner surface 118 of the frame 106. As shown for example in Figs. 14A and 14B, inner skirt 180 defines an inner skirt outer surface 184, facing the frame inner surface 118, and an inner skirt inner surface 185, facing the central longitudinal axis CA of the frame, and optionally facing the leaflet first surface 162 (which is at least partially the leaflet outer surface). The inner skirt 180 can function as a sealing member to prevent or decrease perivalvular leakage, to anchor the valvular structure 50 to the frame 106, and / or to protect the leaflets 52 against damage caused by contact with the frame 106 during crimping and during working cycles of the prosthetic valve 10. In some examples, cusp edge portions 156 of the leaflets 52 can be coupled to the inner skirt 180 generallyTHVFN-23757WOOIalong a scallop-shaped line 142. The inner skirt 180 can in turn be coupled to the frame 106. In some examples, an inner skirt 180 comprises a single sheet of material that extends continuously around frame 106. In some examples, the inner skirt 180 can optionally comprise one or more skirt portions that are connected together and / or individually connected to the frame 106.

[0094] In some examples, the prosthetic valve 10 can further include an outer skirt 170 disposed around outer surface 116 of the frame 106, and configured to function, for example, as a sealing member retained between the frame 106 and the surrounding tissue of the native annulus against which the prosthetic valve is mounted, thereby reducing risk of paravalvular leakage (PVL) past the prosthetic valve 10. As shown for example in Figs. 12A and 12B, outer skirt 170 defines an outer skirt inner surface 175, facing the frame outer surface 116, and an opposing outer skirt outer surface 174, facing away from the frame 106. In some examples, the outer skirt 170 comprises a single sheet of material that extends continuously around the frame 106. In some examples, the outer skirt 170 can optionally comprise one or more skirt portions that are connected together and / or individually connected to the frame 106.

[0095] As used herein, the term “frame-facing surface” refers to a surface of a flexible polymeric structure, or a portion thereof, which is facing the inner or outer surface of frame 106. For example, outer surface 184 is the frame-facing surface of inner skirt 180, as it is the surface thereof which faces inner surface 118 of frame 106, as described above. As another example, when cusp end portion 156 of leaflet 52 is outwardly folded over itself in the radial direction, as described above, the leaflet second surface 164, at the region of cusp end portion 156, is a frame-facing surface.

[0096] Any of an inner skirt 180 and / or outer skirt 170 can optionally comprise various suitable biocompatible materials, such as, but not limited to, natural tissue (e.<j. pericardial tissue), a fabric, or polymeric material, such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, and the like. In some examples, inner skirt 180 and / or outer skirt 170 comprise at least one polymeric material selected from ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, and combinations thereof. Each possibility represents a separate example.

[0097] It is to be understood that an inner skirt and an outer skirt are shown and described herein by way of illustration and not limitation. For example, a prosthetic valve 10 can optionally be provided with an inner skirt 180 and without an outer skirt, in which case, the inner skirt 180 further serves as a PVL sealing member of the valve against the surrounding anatomy. Similarly, a prosthetic valve 10 can optionally be provided with an outer skirt 170 and without an inner skirt, in which case, the leaflet’s cusp end portion156 can be optionally directly coupled (e.g., sutured) to struts 108 of frame 106, as will be described in greater detail below with respect to Fig. 3.

[0098] Various exemplary implementations for prosthetic valve and components thereof, such as frame, leaflets, and the like, 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 prosthetic valve or component thereof, 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 prosthetic valve or component thereof, referred to with a superscript, may be optionally shared by some but not necessarily all other exemplary implementations.

[0099] For example, a prosthetic valve 10% illustrated in Figs. 1A-1B, is an exemplary implementation of a prosthetic valve 10, and thus can include any of the features described for a prosthetic valve 10 throughout the current disclosure, except that the leaflets 52 are indirectly coupled, along the cusp end portions 156, to the frame io6a. Specifically, the cusp end portions 156 of the leaflets 52 are attached to an inner skirt 180 of prosthetic valve ioa, and the inner skirt 180 is attached, in turn, to the frame io6a. In some examples, cusp end portions 156 of the leaflets 52 can be sutured to the inner skirt 180 generally along a scallop-shaped line 142. The inner skirt 180 can in turn be coupled to the frame 106 by one or more fasteners, such as sutures 190.

[0100] Fig. 3 is a perspective side view of an exemplary prosthetic valve iob. Prosthetic valve iobcan be structurally and functionally similar to any example of prosthetic valve 10 described herein, except that the leaflets 52 are directly secured along their cusp end portions 156 to struts 108 the frame 106 of prosthetic valve iobby one or more fasteners, such as suture 190. While an outer skirt 170 is not illustrated in Fig. 3, it is to be understood that a prosthetic valve iobcan optionally include an outer skirt 170 disposed around the frame 106.

[0101] Fig. 4 shows a perspective view of an exemplaiy delivery assembly 250 that includes a deliveiy apparatus 252 adapted to deliver a prosthetic device, which can be any exemplaiy prosthetic valve 10 described above, or any exemplary prosthetic valve too described below with respect to Figs. 5-15. The delivery apparatus 252 can optionally include a handle 254 and at least one catheter extending therefrom, configured to carry a prosthetic valve 10, too in a crimped state through the patient’s vasculature. An exemplary delivery assembly 250 comprises an exemplary delivery apparatus 252 configured to carry a balloon expandable prosthetic valve. The deliveryTHVFN-23757WOOIapparatus 252 can optionally comprise a balloon catheter 260 having an inflatable balloon 262 mounted on its distal end. A prosthetic device, such as prosthetic valve 10, too, can be optionally carried in a crimped state over the balloon catheter 260.

[0102] In some examples, a delivery apparatus 252 further comprises an outer shaft 258.Optionally, an outer shaft 258 of a delivery apparatus 252 can concentrically extend over the balloon catheter 260.

[0103] The outer shaft 258 and the balloon catheter 260 can optionally be configured to be axially movable relative to each other. For example, a proximally oriented movement of the outer shaft 258 relative to the balloon catheter 260, or a distally oriented movement of the balloon catheter 260 relative to the outer shaft 258, can expose the prosthetic valve 10, too from the outer shaft 258.

[0104] A delivery apparatus 252 can optionally further include a nosecone 264 to facilitate advancement of the delivery apparatus 252 through the patient’s vasculature to the site of treatment. A nosecone shaft (concealed from view in Fig. 4) can optionally extend proximally from the nosecone 264 through a lumen of the balloon catheter 260, towards the handle 254.

[0105] In Fig. 4, a prosthetic valve 10, too is mounted on the balloon 262 and is shown in a crimped state, providing prosthetic valve 10, too with a reduced diameter for delivery to the heart via the patient’s vasculature. While the prosthetic valve 10, too is shown in Fig.4 as being crimped or mounted on the balloon 262 for delivery to the treatment location, it should be understood that the prosthetic valve can be optionally crimped or mounted at a location different from the location of balloon 262 {e.g., proximal to the balloon 262) and repositioned over the balloon at some time before inflating the balloon and deploying the prosthetic valve. This off-balloon delivery allows the prosthetic valve to be crimped to a lower profile than would be possible if the prosthetic valve was crimped on top of the balloon 262. The lower profile permits the clinician to more easily navigate the delivery apparatus (including the crimped prosthetic valve) through a patient’s vasculature to the treatment location. The lower profile of the crimped prosthetic valve can be particularly helpful when navigating through portions of the patient’s vasculature which are particularly narrow, such as the iliac artery.

[0106] The proximal ends of the balloon catheter 260, the outer shaft 258, and / or the nosecone shaft, can optionally be coupled to the handle 254. During delivery, the handle 254 can be maneuvered by an operator {e.g., a clinician or a surgeon) to axially advance or retract components of the delivery apparatus 252, such as the nosecone shaft, the outer shaft 258, and / or the balloon catheter 260, through the patient’s vasculatureand / or along the target site of implantation, as well as to inflate the balloon 262 mounted on the balloon catheter 260, for example to expand a prosthetic valve 10, too mounted on the balloon 262, and to deflate the balloon 262 and retract the delivery apparatus 252, for example once the prosthetic valve 10, too is mounted in the implantation site.

[0107] The handle 254 can optionally include a steering mechanism configured to adjust the curvature of a distal end portion of the delivery apparatus 252. In the illustrated example, the handle 254 includes an adjustment member, such as the illustrated rotatable knob 256a, which in turn is operatively coupled to the proximal end portion of a pull wire (not shown). The pull wire can optionally extend distally from the handle 254 through the outer shaft 258 and has a distal end portion affixed to the outer shaft 258 at or near the distal end of the outer shaft 258. Rotating the knob 256a can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 252. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Pat. No. 9,339,384, which is incorporated by reference herein.

[0108] In some examples, the handle 254 can include an adjustment member such as the illustrated rotatable knob 256b, configured to adjust the axial position of the balloon catheter 260 relative to the outer shaft 258, for example for fine positioning at the implantation site. The handle can include additional knobs to control additional components of the delivery apparatus 252. Further details on the delivery apparatus 252 can be found in PCT Application No. PCT / US2021 / 047056, which is incorporated by reference herein.

[0109] A prosthetic valve 10, too can be carried by the delivery apparatus 252 during delivery in a crimped state, and expanded, for example by balloon inflation, to secure it in a native heart valve annulus (such as an aortic annulus) or against a previously implanted prosthetic valve (for example, during valve-in-valve implantation procedures). In some examples, the balloon 262 is secured to a distal end portion of the balloon catheter 260 at its proximal end, while the balloon’s distal end can optionally be coupled, directly or indirectly, to another component of the delivery apparatus 252, such as the nosecone 264 or nosecone shaft.

[0110] Balloon 262 is configured to transition between a deflated and inflated states.Upon reaching the site of implantation, the balloon 262 can be inflated to radially expand the prosthetic valve 10, too. Once the prosthetic valve 10, too is expanded to its functional diameter within a native annulus, the balloon 262 can be deflated, and the delivery apparatus 252 can be retrieved from the patient’s body.THVFN-23757WOOI[om] In some examples, the delivery apparatus 252 with the prosthetic valve 10, too assembled thereon, can be packaged in a sterile package that can be supplied to end users for storage and eventual use. In some examples, when the leaflets of the prosthetic valve are made from, or include at least an inner core made from, bovine pericardium tissue or other natural or synthetic tissues, the leaflets can be treated during the manufacturing process so that they are completely or substantially dehydrated and can be stored in a partially or fully crimped state without a hydrating fluid. In this manner, the package containing the prosthetic valve and the deliveiy apparatus, can be free of any liquid. Methods for treating tissue leaflets for dry storage are disclosed in U.S. Pat. Nos.8,007,992 and 8,357,387, both of which documents are incorporated herein by reference.

[0112] Exemplary prosthetic valve 10 disclosed herein can include one or more flexible structure, such a valvular structure and / or a skirt, which is sutured directly to the frame or to one or more intermediate components coupled to the frame. For example, a valvular structure 50 shown in Fig. 2 can include tissue-based leaflets 52 that can be coupled to the frame 106, directly or via one or more intermediate components (such as a skirt), by one or more sutures 190. A suture 190 used to secure a flexible structure of the valve to the frame, either by suturing directly to struts of the frame for example, or by stitching to another component which in turn is coupled to the frame, can be any suitable suture, such as an Ethibond suture.

[0113] An exemplary frame io6ais shown for use in combination with leaflets 52 equipped with tabs 160 both for exemplary prosthetic valve ioaand iob. Frame io6ais an exemplary implementation of a frame 106, and thus can include any of the features described for a frame 106 throughout the current disclosure, except that each commissure attachment members i22aincludes a commissure window opening 124 extending radially therethrough. When used with leaflets 52 that include opposing commissure tabs 160, each tab 160 is secured to an adjacent tab 160 of an adjacent leaflet 52 to form a commissure 192. Tabs 160 can be passed through the commissure window opening 124 and sutured thereto to secure the commissure 192 to the commissure support member 122. As shown in Figs. 1A and 3, cusp end portions 156 of the leaflets 52 can be sutured to frame io6agenerally along a continuous scalloped line 142 which surrounds frame io6a. In the configuration shown in Fig. 3, for example, scalloped line 142 maybe formed from commissure support member 122 and the angled struts 110S1 on both sides thereof, sequentially continuing, in both directions along the circumference of frame 106, to angled struts 110S1, 110S2, 110S3, 110I, optionally up to an inflow apex 136 and back again to angled struts 1101, 110S3, 110S2, 110S1, until reaching the nextcommissure support member 122, thereby eventually forming an undulating path surrounding frame 106.

[0114] As mentioned, a valvular structure can generally include leaflets formed from tissue-based or polymer-based materials. While suturing of a valvular structure 50 to another component of a prosthetic valve 10 (such as the frame or a skirt of the valve) works well for tissue-based leaflets, it presents various challenges for polymeric leaflets. Specifically, a large number of sutures passed through biocompatible synthetic materials can results in uncontrollable tears, uncontrolled stretching of the suture holes, and as a result, failure of the valvular structure.

[0115] Described herein are examples of prosthetic valves too that can be structurally and functionally similar to any exemplary prosthetic valve 10 described above, except for including at least one flexible polymeric structure, such as a valvular structure or a skirt, configured to be suturelessly attached to the frame 106 of the prosthetic valve too.

[0116] Fig. 5A shows a perspective view of an exemplary prosthetic valve iooc, which is an exemplary implementation of a prosthetic valve 10, too, and thus can include any of the features described for a prosthetic valve 10 or too throughout the current disclosure, except that the prosthetic valve ioocincludes a valvular structure 150 comprising biocompatible polymeric leaflets 152 that are suturelessly attached to its frame 106. An optional outer skirt 170 is removed from view for the sake of clarity.

[0117] Similar to valvular structure 50 described above, a valvular structure 150 comprises a plurality of leaflets 152, which can be structurally and functionally similar to any of the exemplary leaflets 52 described above, except that the leaflets 152 comprise a biocompatible synthetic material. In some examples, leaflets 152 disclosed herein can comprise a first polymer material. Any biocompatible polymers suitable for this desired application can be used. For example and without limitations, biocompatible synthetic materials, or various other suitable natural or synthetic materials are described in U.S. Pat. No. 6,730,118, which is incorporated by reference herein. In some examples, the first polymer material can comprise polyurethane-based composition, polyurea composition, polytetrafluoroethylene (PTFE), silicon, styrene isoprene butadiene (SIBS) block copolymers, or any combination thereof. In some examples, a polyurethane-based composition comprises one or more of poly (ether urethanes), poly (ester urethanes), poly (carbonate urethanes), poly (siloxane urethanes), or any combination thereof. In some examples, the polyurethane-based composition can comprise polyurethanepolyester composites, polyurethane-polyamide composites, polyurethane-glass fiber composites, polyurethane-carbon fiber composites, or any combination thereof. In some examples, the first polymer material can comprise a thermoplastic elastomer. In someexamples, the first polymer material can comprise a thermoplastic elastomer selected from the group consisting of: thermoplastic polyurethane (TPU), styrene block copolymers (TPS), Thermoplastic polyolefinelastomers (TPO), thermoplastic vulcanizates (TPV), thermoplastic copolyester (TPC), thermoplastic polyamides (TPA), and combinations thereof. In some examples, the first polymer material comprises TPU.

[0118] At least a portion of a cusp end portion 156 of one or more leaflets 152° of an exemplary valvular structure 150° is suturelessly attached to at least a portion of the plurality of struts of frame 106 with an adhesive composition 146 to form a coupling portion 144, wherein the coupling portion 144 encapsulates the at least a portion of the plurality of struts and seamlessly extends to the at least a portion of a cusp end portion 156 of the one or more leaflets.

[0119] In some examples, outflow side portions 159 of a leaflet 152 can be devoid of commissure tabs, as illustrated for example in Fig. 6. Fig. 5B is a perspective view of a frame io6c, which is similar to any example of a frame 106 disclosed herein, except that the commissure support members 122Cof frame io6ccan be devoid of commissure window openings. In some examples, outflow side portions 159 of leaflets 152 can be optionally secured to the frame 106, such as to commissure support members 122% by an adhesive composition as described herein, thereby forming coupling portion 144, optionally continuous to the coupling portion 144 formed to couple the cusp end portions 156 to struts of the frame. In the example illustrated in Fig. 5A, the cusp end portions 156 are coupled to sequential angled struts 110S1, 110S2, 110S3, and 110I along an undulating scalloped line path of the coupling portion 144, and outflow end portion 159 of adjacent leaflets 1522are shown to be coupled to the commissure support members 122 forming axially-extending portions of the coupling portion 144.

[0120] Fig. 6 schematically shows a single polymeric leaflet 152 coupled to struts 108 of a frame, along a cusp end portion 156 and outflow side portions 159 of the leaflet, by a coupling portion 144 formed from an adhesive composition 146. In some examples, coupling portion 144 covers substantially the entirety of strut 108, e.g., adhesive composition 146 overlays the whole of strut 108, including end portions of the strut e.g., the junctions or apices at one or both ends of the corresponding strut). In some further examples, coupling portion 144 partially covers strut 108. For example, coupling portion 144 may intermittently cover strut 108, such that the covered and uncovered areas of strut 108 are of substantially equal length. In some examples, the covered areas of strut 108 are 1-10 times the length of the uncovered portions. In some examples, the uncovered areas of strut 108 are 1-10 times the length of the covered portions. For another example, coupling portion 144 covers at least the inflow end of strut 108(positioned adjacently to the leaflet 152 inflow end portion) and the tips of strut 108 at the outflow end thereof. In some further examples, as shown Fig. 6, coupling portion 144 covers the entire length of strut 108 while a junction or an apex on one or both ends of the corresponding strut 108 can remain uncovered.

[0121] While leaflet 152 is illustrated in Figs. 5A and 6 to be devoid to tabs, it is to be understood that a polymer-based leaflet 152 can include, in some examples, tabs 160 at its outflow end portions 159. For example, tabs of leaflet 152s can be optionally coupled to commissure support member 122 by an adhesive composition as described herein. Moreover, it is to be understood that a valvular structure 150 of a prosthetic valve iooccan be coupled to a frame 106 that can include commissure window openings 124, as shown for example for frame io6a.

[0122] Figs. 7A-7B illustrate the process of applying the adhesive composition to a strut and an underlying leaflet, as part of the formation of a coupling portion which couples the strut to the leaflet. Fig. 7A is a cross-sectional view of strut 108 overlying leaflet 152, in preparation to having a polymeric solution 148 applied thereto. In particular, inner surface 118 of strut 108 interfaces with an outwardly-facing surface of leaflet 152, such as the outer surface 162 in the illustrated example, and polymeric solution 148 is applied from the opposite direction towards the outer surface 116 of strut 108. Fig. 7B is a cross- sectional view of strut 108 coupled to the leaflet 152 shown in Fig. 7 A, following application of polymeric solution 148 to form an adhesive composition 146, which seamlessly continues from outer surface 116 of strut 108 to an outwardly-facing surface of leaflet 152, such as the outer surface 162 in the illustrated example. This adhesive composition 146, which in its entirety forms coupling portion 144, maintains strut 108 in close and preferably tight contact with leaflet 152.

[0123] The adhesive composition 146 can be disposed over outer surface 116 of the plurality of struts 108 and a portion of a surface of cusp end portion 156 (and / or outflow side portions 159) of the leaflets 152. In some examples the adhesive composition 146 can form a coupling between struts 108 and an outwardly-facing surface of cusp end portion 156 (and / or outflow side portions 159), such as the outer surface 162 in the illustrated example. In some examples the cusp end portion 156 can be folded outward over itself, such that the outwardly-facing surface facing strut 108 is the second surface 164.

[0124] The adhesive composition 146 can comprise a composition comprising an adhesive polymer, an oligomer, a monomer, or a combination thereof. In some examples, the adhesive polymer material and the leaflet polymer material comprise the same polymer composition. Yet, in other examples, the adhesive polymer can comprise a polymer composition that is different from the leaflet polymer. However, it is understoodTHVFN-23757WOOIthat in such examples, the leaflet and the adhesive polymers are substantially compatible to form a seamless coupling portion. In some examples, while the polymer composition of the leaflet polymer and the adhesive polymer can be the same, these polymers can still differ in molecular weight, different branching structures, and the like. In still further examples, the molecular weight of the polymer composition and degree and type of branching can be tuned to obtain the desired viscosity and solubility characteristics of the adhesive composition.

[0125] It is understood that in examples where the adhesive composition comprises an oligomer, a monomer, or a combination thereof, these oligomers and monomers can represent the same or different structural units of the leaflet polymer. For example, the oligomers and monomers in the adhesive composition can be different from any of the structural units of the leaflet polymer. Yet, in other examples, the oligomers and monomers of the adhesive composition can be represented by at least some of the backbone units that form the leaflet polymer. In still further examples, in addition to the oligomers and monomers of the polymers disclosed above, the composition also can comprise oligomers and monomers of acrylates, epoxy, vinyl, or any combination thereof. In some examples, if the adhesive composition comprises oligomers and monomers, it is understood that such composition can be polymerized after the application to form the coupling portion. Polymerization can be done by any known in the art methods. For example, it can be polymerized by irradiation (e.g., heat, UV- radiation, IR-radiation, and the like).

[0126] In some examples, when the first polymer of the leaflet 152 and the second polymer of adhesive composition 146 have the same polymer composition, the coupling body forms a unibody with the one or more leaflets. In such unlimiting examples, the at least a portion of the plurality of struts is embedded into the adhesive composition, and the adhesive composition non-distinguishably expands into the leaflets. In such examples, the coupling portion seamlessly extends into the cusp end portion of the leaflet, with substantially no rough edges formed at any point of the coupling. In still further examples, the coupling portion can form an edge between the coupling portion and the at least a portion of the leaflet cusp end portion. In still further examples, the adhesive composition substantially diffuses into the desired portion of the cusp end portion of the leaflet. Yet, in still further examples, the adhesive composition can diffuse in a portion of the leaflet that extends beyond the cusp end portion of the leaflet.

[0127] In some examples, coupling portion 144 can have the same thickness as the original cusp end portion 156 of the leaflet. In other examples, the adhesive composition 146 can form a reinforcing portion. In such examples, the reinforcing portion can beTHVFN-23757WOOIformed by an additional layer of adhesive composition 146 that results in an increased thickness around the cusp end portions 156 of the leaflets. Such a reinforcing portion further protects the leaflets from tearing up or any other mechanical damage. In still further examples, coupling portion 144 can have a thickness of about 1 pm to about 500 pm, including exemplary values of about 2 pm, about 5 pm, about 10 pm, about 20 pm, about 30 pm, about 40 pm, about 50 pm, about 60 pm, about 70 pm, about 80 pm, about 90 pm, about 100 pm, about 150 pm, about 200 pm, about 250 pm, about 300 pm, about 350 pm, about 400 pm, and about 450 pm.

[0128] In some examples, coupling portion 144 comprises substantially no gap between the at least a portion of cusp end portion 156 and the at least a portion of the plurality of struts 108, e.g., the gap between the (first or second) surface of cusp end portion 156 and inner surface 118 of struts 108 does not allow polymeric composition 148 to enter thereinto.

[0129] In some examples, the one or more leaflets 152 can comprise a first polymer. Any of the disclosed above first polymers can be utilized. In some examples, the adhesive composition 146 can comprise a composition comprising an adhesive polymer, an oligomer, a monomer, or a combination thereof and a solvent. The adhesive polymer, oligomer, and / or monomer, can comprise any of the disclosed above compounds. In some examples, the solvent can comprise any known in the art solvents that can at least partially dissolve the adhesive polymer and / or oligomer and / or monomer. In such unlimiting examples, the solvent can comprise dimethylacetamide (DMAc), dimethylformamide (DMF), tetrahydrofuran (THF), acetone, isopropyl alcohol (IPA), methyl ethyl ketone (MEK), butyl acetate, and the like, or any combination thereof.

[0130] In still further examples, the polymeric solution 148 can be substantially dissolved in the solvent and dispersed the outwardly-oriented surface of the at least a portion of the cusp end portion 156 of one or more leaflets 152. In some examples, after dispersing the solution in the desired concentration and desired viscosity, some of the portion of the cusp end portion 156 can be slightly dissolved (or melted). In such examples, the adhesive composition 146 and the dissolved portion of leaflet 152 are substantially mixed and seamlessly connected upon the removal of the solvent. The solvent can be removed by any known in the art methods, for example, drying at room temperature and atmospheric pressure, or in a vacuum, or at elevated temperature. In some examples, the solvent is removed at conditions effective to form the desired coupling portion 144. It is understood that conditions are controlled to ensure that leaflets 152 and coupling portions 144 do not lose the desired mechanical and chemicalTHVFN-23757WOOIproperties. In some examples, coupling portion 144 formed by the disclosed herein methods forms a unibody with the one or more leaflets 152.

[0131] In other examples, adhesive polymeric solution 148 can comprise no solvent. In such examples, the adhesive composition can be melted to form a melt solution prior to being applied to the leaflets 152 over the corresponding struts 108. In such examples, the cusp end portion 156 can optionally also be melted to seamlessly incorporate strut 108 within coupling portion 144 and to form a unibody between coupling portion 144 and the leaflets 152.

[0132] In some examples, if needed, adhesive composition 146 can comprise crosslinking materials or polymerization initiators that would allow the quick and efficient formation of coupling portion 144. The specific irradiation conditions will be the conditions effective to provide the desired coupling portion.

[0133] In some examples, the adhesive composition can comprise oligomers or monomers which can be present in the solvent or without the solvent, as disclosed above. In some examples, the oligomers and / or monomers can be dispersed on the aligned struts and leaflets and then polymerized by applying radiation. In some examples, the radiation can be thermal or UV-light or IR-light radiation. In yet further examples, if needed, the adhesive composition can comprise crosslinking materials or polymerization initiators that would allow the quick and efficient formation of the coupling portion. The specific irradiation conditions will be the conditions effective to provide the desired coupling portion.

[0134] In some examples, the adhesive composition 146, when applied, exhibits a viscosity of about 5 mPa-s to about 100,000 mPa-s, including exemplary values of about 10 mPa-s, about 20 mPa-s, about 50 mPa-s, about 100 mPa-s, about 250 mPa-s, about 500 mPa-s, about 750 mPa-s, about 1,000 mPa-s, about 5,000 mPa-s, about 10,000 mPa-s, about 15,000 mPa-s, about 20,000 mPa-s, about 25,000 mPa-s, about 30,000 mPa-s, about 35,000 mPa-s, about 40,000 mPa-s, about 45,000 mPa-s, about 50,000 mPa-s, about 55,000 mPa-s, about 60,000 mPa-s, about 65,000 mPa-s, about 70,000 mPa-s, about 75,000 mPa-s, about 80,000 mPa-s, about 85,000 mPa-s, about 90,000 mPa-s, and about 95,000 mPa-s. In still further examples, the adhesive composition exhibits a surface tension of about 20 mJ / m2to about 60 mJ / m2, including exemplary values of about 25 mJ / m2, about 30 mJ / m2, about 35 mJ / m2, about 40 mJ / m2, about 45 mJ / m2, about 50 mJ / m2, and about 55 mJ / m2.

[0135] It is to be understood, that although coupling of frame 106 to leaflets 152 is illustrated in Figs.5A-7B, similar examples of methods and systems can be applied forcoupling of an inner skirt 180 to frame 106 or an outer skirt 170 to frame 106. For example, an outer skirt 170 can be formed from a first polymer and coupled to struts 108 of frame 106 using an adhesive composition 146 that forms a coupling portion 144 according to any of the examples described above. Similarly, an inner skirt 180 can be formed from a first polymer and coupled to struts 108 of frame 106 using an adhesive composition 146 that forms a coupling portion 144 according to any of the examples described above.

[0136] As set out above, coupling the struts of frame 106 to a flexible polymeric structure, the flexible polymeric structure selected from at least one of leaflets 152, inner skirt 180, and / or outer skirt 170, is achieved by encapsulating selected struts 108 (and / or junctions 132) with adhesive composition 146 which seamlessly continues to a surface of the flexible polymeric structure, thus forming a coupling portion 144. However, this method of coupling may allow for small relative movements of the polymer surface relative to the struts 108 to which it is coupled. These relative movements can lead, over time, to gradual degradation of the flexible polymer structure at the regions of attachment.

[0137] Fig. 8A shows an exemplary polymeric leaflet i52d. Leaflet i52dis an exemplary implementation of polymeric leaflet 152, and thus can include any of the features described for leaflet 152 throughout the current disclosure, except that the leaflet I52dfurther comprises a leaflet textured surface portion 166. Fig. 8B is a magnified view of a portion of leaflet textured portion 166 shown in Fig. 8A. Textured portion 166 is in the location on leaflet t52dto which a strut 108 is intended to be coupled, which in the example shown is along the cusp end portion 156, and optionally at least part of the outflow side portions 159, of leaflet i52d.

[0138] In some examples, the textured portion includes pattern features which can be micropatterns. In general, the patterns or micropatterns include peak regions 167, and trough regions 168 in between and / or surrounding the peak regions. One example of micropattern features that include parallel rows of grooves 167 and ridges 168 is illustrated in Figure 8B, though it is to be understood that other patterns are contemplated. Such a pattern can be optionally created by ablation or subtraction of the material forming troughs or trenches in the otherwise substantially even material (as shown for example in Fig. 9), or deposition or addition of material, creating ridges on the material (as shown for example in Fig. 11A).

[0139] The dimensions between such rows can be of any suitable height (or depth), width, and spacing suitable for enhancing friction and / or enhancing adhesive forces and / or reducing relative movement between a surface of strut 108 and a respectivesurface of a flexible polymeric structure, e.g., the outer surface of an inner skirt (such as inner skirt 180), the inner surface of an outer skirt (such as outer skirt 170), and / or an outwardly-facing surface (which can be either first surface 162 or second surface 164) of leaflets i52d. The area of contact of a surface of strut 108 and a respective surface of a flexible polymeric structure is referred to herein as the “interface region”. The term “adhesive forces,” as used herein, refers to any forces which increase steady attachment between the two surfaces, particularly surfaces having a textured surface portion in their interfacing region. Adhesive forces may include electrostatic forces and or chemical forces, such as Van der Waals force, hydrogen bonds, ionic bonds, covalent bonds and the like, or may include any other adhesive force known in the art.

[0140] In examples of ablation or subtraction, the depth of the troughs e.g., grooves 167) ranges from about 0.5 pm to about 50 pm, including each value within the specified range, and the width of the troughs from about 1 pm to about 50 pm. In examples of deposition, the height of the peaks (e.g., ridges 168) ranges from about 0.5 pm to about 50 pm, and the width of the peaks from about 1 pm to about 50 pm. The dimensions of the spacing between the respective troughs / peaks may be substantially uniform, as illustrated for example in Fig. 9, or may vary due to various considerations. Such considerations include, for example, the angle of the portion of strut 108 relative to the central axis of frame 106, the proximity of the portion of strut 108 to a non-textured portion of the flexible polymeric structure, and the like. For example, the textured portion can have denser spacing at the edges thereof, e.g., at the areas of the textured surface portion which border with a non-textured portion of the surface of the polymeric structure. Additional considerations such as availability of different texture-forming tools and mechanisms may also affect the texture of the textured portion.

[0141] In some examples, the troughs and peaks have substantially similar dimensions, e.g., in the example of grooves 167 and ridges 168, grooves 167 have substantially the same length and / or substantially the same width as ridges 168. In some further examples, the troughs and peaks may have different dimensions, e.g., the troughs may have a larger or smaller width than the peaks. While Figures 8B and 9 illustrate linear rows, various implementations may utilize zigzags, waves, sinusoids, “plum-pudding” pattern, and / or other patterning of peak regions and / or through regions on the material that enhances friction and / or enhances adhesive forces and / or reduces relative movement between a surface of strut 108 and a respective surface of a flexible polymeric structure.

[0142] Pattern features can also comprise multidimensional and / or multilayered patterning. In some instances, a smaller pattern (e.g., nanopatterns) can be combinedTHVFN-23757WOOIwithin a larger size pattern (e.g., micropattern). For example, the textured portion may include a “chessboard” pattern, where a larger grid is created over a smaller grid. The height of the larger grid can be taller than the smaller grids, and the smaller grids can be embedded into the larger grid. The grid lines of the larger grid can protrude from the surface. The larger grids and the smaller grids can be square or rectangular shapes. In various instances, the larger grid can be created via direct laser writing or interference lithography, while the smaller pattern is created via interference lithography. Direct laser writing can create patterns on even and / or uneven surfaces. Interference lithography may be able to create patterns on even surfaces. Multidimensional structures in various implementations can be any geometry to enhances friction and / or enhances adhesive forces and / or reduces relative movement between a surface of strut 108 and a respective surface of a flexible polymeric structure, including (but not limited to) circular, ovular, oblong, triangular, quadrilateral (e.g., square, rectangular, rhomboidal, trapezoidal), hexagonal, octagonal, any other regular or irregular shape or polygon, and combinations thereof.

[0143] Fig. 9 shows an exemplary process of forming textured portion 166 of an exemplary leaflet i52d, the textured portion 166 including grooves 167 and ridges 168, using a toothed instrument 270 including teeth 272. In some examples, the polymeric leaflet (e.g., valvular structure) is formed (e.g., by a mold) optionally including a marked area which is intended to function as the leaflet textured portion 166. A toothed instrument 270 (e.g., a comb-like device) that includes many small-dimensioned outwardly-extending spikes or protrusions, referred to herein as teeth 272, is then passed over the marked area on the surface of the leaflet to create a desired pattern of textured portion 166. In some examples, the leaflet textured portion 166 (and / or the textured portion of the inner skirt and / or the outer skirt, as described herein) may have a width WT (indicated, for example, in Fig. 8B) which substantially corresponds to the width WS of a strut 108 (indicated, for example, in Fig. 1B). In some further examples, the textured portion has a width WT which is between 2O%-15O% the width of WS, or any intermediate range, e.g., between 7596-125%, between 5o%-ioo%, between 25%-5O%, or between 50%-i50% of WS. In some examples, the width WT maybe about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, about 100%, about 110%, or about 125% of WS.

[0144] As mentioned above, the textured pattern can be created by ablation or subtraction of the material of the struts and / or of the flexible polymeric structure, forming troughs or trenches in the otherwise substantially even material, or by deposition or addition of material, creating ridges on the material. The examplerepresented in Fig. 9 is an example of a method of subtracting material from the surface of a flexible polymeric structure.

[0145] In further examples, particularly but not limited to when a textured portion is formed on the surface of the struts, subtracting the material of the strut and / or of the flexible polymeric structure can be achieved by other or additional subtraction methods. In some examples, the formation of the textured portion is achieved by at least one subtraction method selected from chemical etching, electro-etching, irradiation, laser engraving, and photo-ablation. In some examples, the region which is to be given a patterned texture, e.g., to be formed into the textured portion, may be masked by a material which is resistant to the etching, ablation, or any other subtraction method which is to be applied to the surface of the material. In some examples, the material of the mask has the same pattern as the desired textured portion, wherein the gaps in the mask material correspond to the trough regions of the desired textured portion and the mask material itself corresponds to the peak regions.

[0146] In other examples, when the pattern of the textured portion is formed by deposition or addition of material, the patterned mask can be used such that the gaps in the mask material correspond to the peak regions of the desired textured portion (as the deposited material enters the gaps), and the mask material itself corresponds to the trough regions.

[0147] In some examples, portions of a flexible polymeric structure which are not attached to the frame 106, such as portions of the flexible polymeric structure extending between struts 108 to which the polymeric structure is coupled, can be mostly devoid of a pattern that includes peak and through regions. For example, both surfaces 162 and 164 of the movable body 158 of leaflet i52d can remain substantially smooth along most of the area of the leaflet body 158 e.g., at least 90% of the area of the leaflet body). Surface 164 of the leaflet body 158 is exposed to blood flowing through the valvular structure 150, such as during systole in the case of an aortic valve, and surface 162 of the leaflet body 158 is exposed to blood accumulated between the leaflet 152 and a surrounding skirt that can serve as a sealing member, such as during diastole in the case of an aortic valve. It may be desired, in some examples, to maintain one or both of these surfaces 162, 164 relatively smooth, for example to prevent undesired biologic response by which thrombosis or clotting can occur when blood constituents are irritates by textures surfaces exposed thereto.

[0148] Fig. 10A shows an exemplary frame io6e. Frame io6eis an exemplary implementation of frame 106, and thus can include any of the features described for frame 106 throughout the current disclosure, except that the frame io6efurtherTHVFN-23757WOOIcomprises a frame textured surface portion 138 on the inner surface 118 of some of its struts 108. Fig. 10B is a magnified view of a portion of the of frame io6ethat includes the textured surface portion 138. The frame textured portion 138 is formed over a surface of the struts 108 to which a flexible polymeric structure, such as valvular structure 150, is coupled. In the illustrated example, the frame textured portion 138 is shown to be formed along a continuous path of struts 108 which form a scalloped line (tracking the scalloped line 142), progressing from commissure support member 122 to angled struts 110S1 on both sides thereof, and sequentially continuing, in both directions, to angled struts 110S2, 110S3, 110I, and back again to 110S3, 110S2, 110S1, and another commissure support member 122. As explained above, this scalloped line of struts 108, having a textured portion 138 on inner surface 118 thereof, can be at the interface region between frame io6eand a polymeric leaflet 152, along a path corresponding to the cusp end portion of polymeric leaflets 152. In some examples, the cusp end portion 156 of leaflet 152 is coupled to the textured line of struts 108 by a coupling portion 144, as explained above, such that the textured portion 138 enhances friction and / or enhances adhesive forces and / or reduces relative movement between the inner surface 118 of strut 108 and a respective surface of leaflet 152 at the interface region therebetween.

[0149] As set out above, in some examples, inner surface 118 is coupled to an outwardly- facing surface of the corresponding portion(s) of attachment of the leaflet 152 (such as cusp end portions 156 and / or outflow side portions 159). In some examples, at least a portion of the leaflet 152 or the strut of frame 106 have a textured surface at the interface region therebetween. In some examples, the struts 108 have a surface textured portion 138 along the entire length and / or area of the interface region with leaflet 152. In some examples, the struts 108 have a textured surface portion 138 along at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 70%, at least 80%, at least 90%, at least 95%, or at least 99% of length and / or area of the interface region with leaflet 152. In some examples, leaflet 152 has a textured portion 166 along the entire length and / or area of the interface region with struts 108 if frame 106. In some examples, leaflet 152 has a textured portion 166 along at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 70%, at least 80%, at least 90%, at least 95%, or at least 99% of length and / or area of the interface region with struts 108 of frame 106.

[0150] In some examples, both of struts 108 and the leaflet 152 have a frame textured portion 138 and a leaflet textured portion 166, respectively, at the interface region therebetween. In some examples, the textured portions 138, 166 of struts 108 and leaflet 152 are in different portions of the interface region, such that at any point on theinterface region there is either the textured portion 138 (of inner surface 118) of strut 108, or textured portion 166 of the first or second surface of leaflet 152. In some further examples, the textured portions 138, 166 of struts 108 and leaflet 152 are at the same portions of the interface region, such that textured portion 138 and textured portion 166 at least partially interface. In some examples, textured portion 138 of struts 108 and textured portion 166 of leaflet 152 are complementary to each other, such that the peak regions of textured potion 138 substantially fit into the trough regions of textured portion 166, and vice versa.

[0151] As an unlimiting example, textured portion 138 of struts 108 and textured portion 166 of leaflet 152 can both be in the form or parallel rows of grooves and ridges (such as grooves 167 and ridges 168), which grooves are formed such that when leaflet 152 is positioned against struts 108 of frame 106, the ridges of strut textured portion 138 fit into the grooves of leaflet textured portion 166, and the ridges of leaflet textured portion 166 fit into the grooves of strut textured portion 138. In some further examples, textured portion 138 of struts 108 and textured portion 166 of leaflet 152 are not complementary to each other, such that at least part of the peak regions of strut textured portion 138 interface with at least part of the peak regions of leaflet textured portion 166.

[0152] In some examples, the leaflets i52dcan include a textured portion 166 while all struts 108 of the frame 106 are relatively smooth and devoid of textured portions. In some examples, the frame io6ecan include textured portion 138 while the portions of the leaflets 152 contacted thereby remain relatively smooth and devoid of textured portions.

[0153] Insome examples, portions of the frame 106 which are not coupled to a corresponding flexible polymeric structure, can be devoid of a pattern that includes peak and through regions. For example, the inner surface 118 along struts 108 of the frame io6dwhich are not coupled to the leaflets 152 can remain substantially smooth. Struts 108 facing the movable bodies 158 of leaflets 152 can be contacted by the leaflet bodies 158 when the valvular structure is in an open state, such as during systole in the case of an aortic valve. If all struts 108 of a frame are formed to have a textured surface along their inner surface 118, continuous cycling of the leaflets between their closed and open state can eventually lead to material abrasion due to their contact with such abrasive surfaces. Thus, it may be desired to preserve a relatively smooth inner surface 118 along any portion of the frame io6ethat can be contacted by movable bodies 158 of the leaflets 152 to improve long-term durability of the valvular structure 150.

[0154] It is to be understood that any example illustrated and / or explained with relation to a flexible polymeric structure such as leaflet 152, inner skirt 180 and outer skirt 170, should be taken as an example which can similarly apply to any of the other flexiblepolymeric structures, unless explicitly said to be applicable only to the exemplified flexible polymeric structure.

[0155] Figs. tiAand 11B represent exemplary interface regions of a flexible polymeric structure and a strut, at least one of which is formed to include a textured portion. Fig.11A is a cross-sectional view of an interface region of leaflet i52dand a strut 108 of prosthetic valve iood, including a textured portion 166 having ridges 168 protruding skewedly from first surface 162 thereof. Adhesive composition 146 encapsulates strut 108 and couples it to leaflet i52d. The peaks 167 of textured surface portion 166 are shown in the illustrated example to extend outward beyond the plain of bordering, or surrounding, surface 162 (which is the outwardly-oriented surface in the illustrated example) towards strut 108, such that grooves 167 are essentially at the same level as surface 162 to which they belong, e.g., in the non-textured portions thereof, and ridges 168 protrude therefrom towards strut 108. In other examples (as shown for example in Figs. 8A-9), the trough regions 167 are burrowed into the surface, reaching a deeper layer of their respective flexible polymeric structure, and the peak regions are at essentially the same level as the surface. In still further examples, both the peak regions and the trough regions are not at the same level as the surface to which they belong, the peak regions extending therefrom towards the interfacing surface and the trough regions being somewhat deeper than the surface. This may be brought about, for example, by the textured region being formed by a combination of deposition and ablation.

[0156] In some examples, as further illustrated in Fig. 11A, peak regions 168 of a leaflet i52dcan be angularly skewed relative to the surface which they are interfacing at the interface region. , chosen to facilitate a “climbing” movement of the leaflet i52dover the surface of the strut 108 to which it is coupled, during cycling movement of the leaflet i52dbetween the closed and open state of the valvular structure. In some examples, a nonvertical angle of peak regions 168 is in the range of 1-75 degrees relative to the corresponding outwardly-facing surface the extend from. In some examples, the nonvertical angle of peak regions 168 is in the range of 1-15, 10-30, 15-45, 30-60, 30-45, or 15-75 degrees relative to the corresponding outwardly-facing surface the extend from.

[0157] Fig. 11B is a cross-sectional view of an interface region of strut 108 of frame io6eand leaflet 152 of prosthetic valve iooe, including textured portion 138 having peak regions 139 protruding substantially perpendicularly from the strut inner surface 118. In some examples, the peak regions may have a non-vertical angle relative to their respective surface.

[0158] Fig. 12A shows a pre-assembled flattened view of an exemplary outer skirt i of.The outer skirt iyofaxially extends between a skirt inflow end portion 172 and a skirtoutflow end portion 171, and can be similar to any example described above with respect to an outer skirt 170, except that the inner surface 175 of outer skirt i7Ofincludes a textured portion 176. While both the outflow end portion 171 and the inflow end portion 172 of the outer skirt 170 are shown in the illustrated example to be relatively linear, it is to be understood that at least one of the end portions 171, 172 can have a non-linear shape, such as an undulating or zig-zagged shape that can generally following the angling of angled struts no of a respective rung 112 to which the end portion of the skirt is attached.

[0159] As shown in Fig. 12A, an outer skirt 170 can include opposing skirt side portions, such as skirt first side portion 173a and skirt second side portion 173b. Compared to the skirt inflow end portion 172 and the skirt outflow end portion 171, the skirt side portions 173a, 173b can be also referred to as short edges of the outer skirt, wherein each of the skirt side portions 173a, 173b extends between the skirt inflow end portion 172 and the skirt outflow end portion 171. In some examples, the first and second side portions 173a, 173b can be non-perpendicular to the skirt inflow end portion 172. For example, the skirt first and second side portions 173a, 173b can extend at angles of about 45 degrees (or in a range of 40 to 50 degrees) relative to the skirt inflow end portion 172. Therefore, an overall general shape of the outer skirt 170 can be that of a rhomboid or parallelogram.

[0160] Fig. 12B shows the outer skirt i7Ofof Fig. 12A rolled to a cylindrical shape, which can be performed during and / or prior to attachment to the frame 106. In some examples, the skirt first and second side portions 173a, 173b can optionally overlap and be secured to one another to form the annular configuration of the outer skirt 170. In some examples, skirt i7Ofcan be disposed upon and connected to frame 106 with an adhesive composition 146 forming a coupling portion similar to coupling portion 144.

[0161] In some examples, the textured portion 176 of inner surface 175 is positioned such that when skirt 170’ is wrapped into its cylindrical form (as shown in Fig. 12B) and is arranged against the frame outer surface 116, the textured portion 176 contacts at least a portion of struts 108. This is referred to herein as textured portion 176 corresponding to at least a portion of struts 108. In some further examples, textured portion 176 corresponds to the entire formation of struts 108 in the portion of frame outer surface 116 against which outer skirt i7Ofis positioned. In other words, in some examples outer skirt t7Ofhas a textured surface 176 in the entire interface region of outer skirt 170 with struts 108.

[0162] In some examples, portions of an inner surface 175 of the outer skirt 170’ extending between struts 108 contacted by the outer skirt 170’, can be mostly devoid of a pattern that includes peak and through regions. For example, the inner surface 175 of theouter skirt i ofcan remain substantially smooth along most of the area exposed to openings defined by corresponding cells 126 of the frame 106 (e.g. at least 90% of the area of inner surface 175 exposed to openings defined by corresponding cells 126). As mentioned above, the valvular structure 150 cycles between open and closed states thereof, wherein leaflets 152 can be pressed against the frame 106 in the open state. In the absence of an inner skirt, portions of the leaflets 152 can optionally protrude outward through openings of cells 126 in the open state, and thus come into contact with corresponding portions of the inner surface 175 of the outer skirt i7Of. Thus, it may be desired to preserve a relatively smooth inner surface 175 along any portion of the outer skirt 1701that can be contacted by movable bodies 158 of the leaflets 152 to improve longterm durability of the valvular structure 150.

[0163] Fig. 13 is a perspective view of an exemplary frame io6g. Frame io6gis an exemplary implementation of frame 106, and thus can include any of the features described for frame 106 throughout the current disclosure, except that at least a portion of the struts 108 of frame io6gdefine a textured surface portion 138 on an outer surface 116 of the struts 108, along a height of the frame io6gcorresponding to the height at which the outer skirt 170 is disposed thereupon. In some examples, frame io6ghas a textured strut surface 138 along the entire formation of struts 108 in the portion of frame outer surface 116 against which an outer skirt 170 is positioned. In other words, in some examples frame 106" has struts 108 having a textured surface 138 in the entire interface region of outer skirt 170 with outer surface 116 of struts 108. In some examples, struts 108 along portions of the frame io6gextending past the outer skirt 170 have a relatively smooth outer surface 116, devoid of any peak or through regions.

[0164] Fig. 14A shows a pre-assembled flattened view of an exemplary inner skirt i8oh.The inner skirt i8ohaxially extends between a skirt inflow end portion 182 and a skirt outflow end portion 181, and can be similar to any example described above with respect to an inner skirt 180, except that the outer surface 184 of inner skirt i8ohincludes a textured portion 186. While both the outflow end portion 181 and the inflow end portion 182 of the inner skirt i8ohare shown in the illustrated example to be relatively linear, it is to be understood that at least one of the end portions 181, 182 can have a non-linear shape, such as an undulating or zig-zagged shape that can generally following the angling of angled struts no of a respective rung 112 to which the end portion of the skirt is attached.

[0165] As shown in Fig. 14A, an inner skirt i8ohcan include opposing skirt side portions, such as skirt first side portion 183a and skirt second side portion 183b. Compared to the skirt inflow end portion 182 and the skirt outflow end portion 181, the skirt side portionsTHVFN-23757WOOI183a, 183b can be also referred to as short edges of the inner skirt, wherein each of the skirt side portions 183a, 183b extends between the skirt inflow end portion 182 and the skirt outflow end portion 181. In some examples, the first and second side portions 183a, 183b can be non-perpendicular to the skirt inflow end portion 182. For example, the skirt first and second side portions 183a, 183b can extend at angles of about 45 degrees (or in a range of 40 to 50 degrees) relative to the skirt inflow end portion 182. Therefore, an overall general shape of the inner skirt 180 can be that of a rhomboid or parallelogram.

[0166] Fig. 14B shows the inner skirt i8ohof Fig. 14B rolled to a cylindrical shape, which can be performed during and / or prior to attachment to the frame 106. In some examples, the skirt first and second side portions 183a, 183b can optionally overlap and be secured to one another to form the annular configuration of the inner skirt 180. In some examples, inner skirt 180 can be disposed within and connected to frame 106 with an adhesive composition 146 forming a coupling portion similar to coupling portion 144.

[0167] In some examples, the textured portion 186 of outer surface 184 is positioned such that when skirt i8ohis wrapped into its cylindrical form (as shown in Fig. 14B) and is arranged against the frame inner surface 118, the textured portion 186 contacts at least a portion of struts 108. This is referred to herein as textured portion 186 corresponding to at least a portion of struts 108. In some further examples, textured portion 186 corresponds to the entire formation of struts 108 of the portion of frame inner surface 118 against which inner skirt i8ohis positioned.

[0168] In some examples, portions of an outer surface 184 of the inner skirt i8ohextending between struts 108 contacted by the inner skirt i8oh, can be mostly devoid of a pattern that includes peak and through regions. For example, the outer surface 184 of the inner skirt 18011can remain substantially smooth along most of the area exposed to openings defined by corresponding cells 126 of the frame 106 (e.<j. at least 90% of the area of outer surface 184 exposed to openings defined by corresponding cells 126).

[0169] Fig. 15 is a perspective view of an exemplary frame 106’. Frame io6‘ is an exemplary implementation of frame 106, and thus can include any of the features described for frame 106 throughout the current disclosure, except that at least a portion of the struts 108 of frame 106' define a textured surface portion 138 on an inner surface 118 of the struts 108, along a height of the frame 106' corresponding to the height at which the inner skirt 180 is disposed therein. In some examples, frame io6‘ has a textured strut surface 138 along the entire formation of struts 108 in the portion of frame inner surface 118 against which inner skirt 180 is positioned. In other words, in some examples frame 106' has struts 108 having a textured surface 138 in the entire interface region of inner skirt 180 with inner surface 118 of struts 108.THVFN-23757WOOI

[0170] In some examples, struts 108 along portions of the frame io6‘ extending past the inner skirt 180 have a relatively smooth inner surface 118, devoid of any peak or through regions. As mentioned above, the valvular structure 150 cycles between open and closed states thereof, wherein leaflets 152 can be pressed, in the open state, against a portion of the frame 106 which is not covered by the inner skirt 180. Thus, it may be desired to preserve a relatively smooth inner surface 118 along any portion of the frame 106' that can be contacted by movable bodies 158 of the leaflets 152 to improve long-term durability of the valvular structure 150.

[0171] Any of the assemblies, devices, apparatuses, etc. herein can be sterilized (for example, with heat, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated assembly, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultraviolet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.

[0172] Some Examples of the Disclosed Implementations

[0173] 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.

[0174] Example 1. A prosthetic valve comprising: a frame configured to transition between a radially expanded and a crimped state, wherein the frame comprises a plurality of intersecting struts; and at least one flexible polymeric structure suturelessly coupled to the frame by a coupling portion that encapsulates at least a portion of the plurality of struts; wherein a portion of a frame-facing surface along a portion of the at least one flexible polymeric structure which is coupled to the corresponding plurality of encapsulated struts, is interfacing at an interface region with a surface of the encapsulated struts facing the corresponding portion of the flexible polymeric structure coupled thereto; and wherein at least one of the flexible polymeric structures and the at least one strut comprises a textured surface formed along at least a portion of the interface region.

[0175] Example 2. The prosthetic valve of any example herein, particularly of example 1, wherein the textured surface is configured to limit relative movement between the at least one flexible polymeric structure and the corresponding struts coupled thereto along the interface region.

[0176] Example 3. The prosthetic valve of any example herein, particularly of example 1, wherein the textured surface is configured to enhance friction between the at least one flexible polymeric structure and the corresponding struts coupled thereto along the interface region.

[0177] Example 4. The prosthetic valve of any example herein, particularly of example 1, wherein the textured surface is configured to enhance adhesive forces between the at least one flexible polymeric structure and the corresponding struts coupled thereto along the interface region.

[0178] Example 5. The prosthetic valve of any example herein, particularly of any one of examples 1—4, wherein the flexible polymeric structure comprises the textured surface at the at least a portion of the interface region.

[0179] Example 6. The prosthetic valve of any example herein, particularly of example 5, wherein a width of the textured surface is in the range of 2O%-15O% of a strut width of the corresponding struts coupled thereto.

[0180] Example 7. The prosthetic valve of any example herein, particularly of example 6, wherein the width of the textured surface is equal to the width of the strut width.

[0181] Example 8. The prosthetic valve of any example herein, particularly of any one of examples 1-4, wherein the corresponding struts coupled to the flexible polymeric structure comprise the textured surface at the at least a portion of the interface region.

[0182] Example 9. The prosthetic valve of any example herein, particularly of example 8, wherein the textured surface of the struts is a first textured surface, and wherein the flexible polymeric structure comprises a second textured surface at the at least a portion of the interface region.

[0183] Example 10. The prosthetic valve of any example herein, particularly of example 9, wherein the second textured surface of the flexible polymeric structure is complementary to the first textured surface.

[0184] Example 11. The prosthetic valve of any example herein, particularly of any one of example 1-10, wherein the at least one flexible polymeric structure comprises at least one of: a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve; an inner skirt mountedTHVFN-23757WOOIon an inner surface of the frame; and an outer skirt mounted on an outer surface of the frame.

[0185] Example 12. The prosthetic valve of any example herein, particularly of example 11, wherein the at least one flexible polymeric structure defining the interface region comprises the valvular structure.

[0186] Example 13. The prosthetic valve of any example herein, particularly of example 12, wherein the portion of the flexible polymeric structure coupled to the frame by the coupling portion comprises cusp end portions of the leaflets.

[0187] Example 14. The prosthetic valve of any example herein, particularly of example 13, wherein the cusp end portions of the plurality of leaflets collectively define a scalloped line of attachment of the valvular structure to the frame.

[0188] Example 15. The prosthetic valve of any example herein, particularly of any one of examples 13 or 14, wherein the frame-facing surface of the cusp end portions of the leaflets is a first surface of the leaflets.

[0189] Example 16. The prosthetic valve of any example herein, particularly of example 15, wherein the first surface of the leaflets is an outer surface of body portions of the leaflets oriented radially outwards.

[0190] Example 17. The prosthetic valve of any example herein, particularly of any one of examples 13 or 14, wherein the cusp end portions of the leaflets are folded outward over themselves, wherein the frame-facing surface of the cusp end portions is a second surface of the leaflets, which is an inner surface of body portions of the leaflets oriented radially inwards.

[0191] Example 18. The prosthetic valve of any example herein, particularly of any one of examples 11-17, wherein the at least one flexible polymeric structure defining the interface region comprises the inner skirt, wherein the frame-facing surface of the inner skirt is an outer surface of the inner skirt, and wherein the inner skirt comprises the textured surface formed on its outer surface.

[0192] Example 19. The prosthetic valve of any example herein, particularly of any one of examples 11-18, wherein the at least one flexible polymeric structure comprises the outer skirt, wherein the frame-facing surface of the outer skirt is an inner surface of the outer skirt, and wherein the outer skirt comprises the textured surface on its inner surface.THVFN-23757WOOI

[0193] Example 20. The prosthetic valve of any example herein, particularly of any one of examples 1—19, wherein the textured surface comprises peak regions and trough regions.

[0194] Example 21. The prosthetic valve of any example herein, particularly of example 20, wherein the peak regions comprise row-shaped ridges, and wherein the trough regions comprise row-shaped grooves.

[0195] Example 22. The prosthetic valve of any example herein, particularly of any one of examples 20 or 21, wherein the peak regions of the textured surface extend beyond a plane of a non-textured surface bordering with the textured surface.

[0196] Example 23. The prosthetic valve of any example herein, particularly of any one of examples 20—21, wherein the peak regions extend vertically relative to a plane of a non-textured surface bordering with the textured surface.

[0197] Example 24. The prosthetic valve of any example herein, particularly of any one of examples 20—21, wherein the peak regions extend at an angle relative to a plane of a non-textured surface bordering with the textured surface.

[0198] Example 25. The prosthetic valve of any example herein, particularly of example 24, wherein the angle is between 1-75 degrees relative to the plane of the non-textured surface bordering with the textured surface.

[0199] Example 26. The prosthetic valve of any example herein, particularly of any one of examples 1-25, wherein the coupling portion is formed from an adhesive composition.

[0200] Example 27. The prosthetic valve of any example herein, particularly of any one of examples 1—26, wherein the at least one flexible polymeric structure comprises a first polymer material.

[0201] Example 28. The prosthetic valve of any example herein, particularly of example 27, wherein the first polymer material comprises a thermoplastic elastomer.

[0202] Example 29. The prosthetic valve of any example herein, particularly of example 28, wherein the thermoplastic elastomer comprises thermoplastic polyurethane.

[0203] 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.THVFN-23757WOOI

[0204] In view of the many possible examples to which the principles of the disclosure may be applied, it should be recognized that the illustrated examples are only preferred examples and should not be taken as limiting the scope. Rather, the scope is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.

Claims

WHAT IS CLAIMED IS:

1. A prosthetic valve comprising:a frame configured to transition between a radially expanded and a crimped state, wherein the frame comprises a plurality of intersecting struts, the frame defining an inner surface and an opposing outer surface; and at least one flexible polymeric structure suturelessly coupled to the frame by a coupling portion that encapsulates at least a portion of the plurality of struts; wherein a portion of a frame-facing surface along a portion of the at least one flexible polymeric structure which is coupled to the corresponding plurality of encapsulated struts, is interfacing at an interface region with a surface of the encapsulated struts facing the corresponding portion of the flexible polymeric structure coupled thereto; andwherein at least one of the flexible polymeric structures and the at least one strut comprises a textured surface formed along at least a portion of the interface region.

2. The prosthetic valve of claim i, wherein the textured surface is configured to limit relative movement between the at least one flexible polymeric structure and the corresponding struts coupled thereto along the interface region.

3. The prosthetic valve of claim 1, wherein the textured surface is configured to enhance friction between the at least one flexible polymeric structure and the corresponding struts coupled thereto along the interface region.

4. The prosthetic valve of any one of claims 1-3, wherein the flexible polymeric structure comprises the textured surface at the at least a portion of the interface region.

5. The prosthetic valve of any one of claims 1-3, wherein the corresponding struts coupled to the flexible polymeric structure comprise the textured surface at the at least a portion of the interface region.

6. The prosthetic valve of any one of claim 1-5, wherein the at least one flexible polymeric structure comprises at least one of:a valvular structure mounted inside the frame and comprising a plurality of leaflets configured to regulate flow through the prosthetic valve;an inner skirt mounted on an inner surface of the frame; andan outer skirt mounted on an outer surface of the frame.

7. The prosthetic valve of claim 6, wherein the at least one flexible polymeric structure defining the interface region comprises the valvular structure.THVFN-23757WOOI8. The prosthetic valve of claim 7, wherein the portion of the flexible polymeric structure coupled to the frame by the coupling portion comprises cusp end portions of the leaflets.

9. The prosthetic valve of claim 8, wherein the cusp end portions of the plurality of leaflets collectively define a scalloped line of attachment of the valvular structure to the frame.

10. The prosthetic valve of any one of claims 8 or 9, wherein the frame-facing surface of the cusp end portions of the leaflets is a first surface of the leaflets.

11. The prosthetic valve of claim 10, wherein the first surface of the leaflets is an outer surface of body portions of the leaflets oriented radially outwards.

12. The prosthetic valve of any one of claims 8 or 9, wherein the cusp end portions of the leaflets are folded outward over themselves, wherein the frame-facing surface of the cusp end portions is a second surface of the leaflets, which is an inner surface of body portions of the leaflets oriented radially inwards.

13. The prosthetic valve of any one of claims 6-12, wherein the at least one flexible polymeric structure defining the interface region comprises the inner skirt, wherein the frame-facing surface of the inner skirt is an outer surface of the inner skirt, and wherein the inner skirt comprises the textured surface formed on its outer surface.

14. The prosthetic valve of any one of claims 6-13, wherein the at least one flexible polymeric structure comprises the outer skirt, wherein the frame-facing surface of the outer skirt is an inner surface of the outer skirt, and wherein the outer skirt comprises the textured surface on its inner surface.

15. The prosthetic valve of any one of claims 1-14, wherein the textured surface comprises peak regions and trough regions.

16. The prosthetic valve of claim 15, wherein the peak regions comprise rowshaped ridges, and wherein the trough regions comprise row-shaped grooves.

17. The prosthetic valve of any one of claims 15 or 16, wherein the peak regions of the textured surface extend beyond a plane of a non-textured surface bordering with the textured surface.

18. The prosthetic valve of any one of claims 15-16, wherein the peak regions extend vertically relative to a plane of a non-textured surface bordering with the textured surface.THVFN-23757WOOI19- The prosthetic valve of any one of claims 15-16, wherein the peak regions extend at an angle relative to a plane of a non-textured surface bordering with the textured surface.

20. The prosthetic valve of claim 19, wherein the angle is between 1 and 75 degrees relative to the plane of the non-textured surface bordering with the textured surface.

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