Frame for prosthetic heart valve

Abstract

A prosthetic heart valve includes a radially expandable and compressible annular frame having a plurality of interconnected angled struts defining a plurality of axially extending columns arranged circumferentially around the frame. The angled struts are arranged to form a first row of angled struts at the first end of the frame, one or more intermediate rows of angled struts, and a second row of angled struts at the second end of the frame. The angled struts include a plurality of reinforced struts and a plurality of non-reinforced struts. The plurality of reinforced struts each have a width greater than a width of each of the non-reinforced struts. A first set of columns of the axially extending columns are reinforced columns including one or more reinforced struts. The reinforced columns are disposed in a circumferentially symmetric pattern about the circumference of the frame.

Description

FRAME FOR PROSTHETIC HEART VALVEFIELDCROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 664,310, filed June 26, 2024, which is incorporated herein by reference in its entirety.FIELD

[0002] The present application relates to expandable prosthetic heart valves, including frames for prosthetic heart valves.BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.

[0004] Most expandable, transcatheter heart valves comprise a radially expandable and compressible cylindrical metal frame and prosthetic leaflets mounted inside the frame. In some examples, a prosthetic heart valve can be implanted within the aortic root, which includes the right and left coronary ostia and is defined between the native aortic valve annulus and the sinotubular junction (STJ). The prosthetic heart valve can be implantedeither within the native aortic valve or within a previously implanted prosthetic heart valve (e.g., previously implanted via a valve-in-valve (ViV) procedure).SUMMARY

[0005] Described herein are prosthetic heart valves, delivery apparatuses, and methods for implanting prosthetic heart valves. In particular, described herein are examples of radially expandable and compressible frames for prosthetic heart valves. The frame of a prosthetic heart valve can comprise a plurality of interconnected struts that define a plurality of axially extending columns arranged circumferentially around the frame. The plurality of interconnected angled struts can be arranged to form a first row at a first end of the frame, one or more intermediate rows of angled struts, and a second row of angled struts at a second end of the frame.

[0006] In some examples, the plurality of angled struts can comprise a plurality of reinforced struts and a plurality of non-reinforced struts, wherein the plurality of reinforced struts each have a width greater than a width of each of the non-reinforced struts.

[0007] In some examples, a first set of columns of the plurality of axially extending columns are configured as reinforced columns comprising one or more reinforced struts. In some examples, the reinforced columns are disposed in a circumferentially symmetric pattern about the circumference of the frame. In some examples, the frame can comprise a second set of columns configured as non-reinforced columns that do not have any reinforced struts.

[0008] In some examples, the width of each of the reinforced struts can be between 0.3 mm and 1.0 mm.

[0009] In some examples, the frame can comprise nine axially extending columns, six of which are configured as reinforced columns and three of which are configured as nonreinforced columns. The non-reinforced columns can be disposed 120 degrees from one another about the circumference of the frame.

[0010] In some examples, the frame can comprise nine axially extending columns, three of which are configured as reinforced columns. The reinforced columns can be disposed 120 degrees from one another about the circumference of the frame.

[0011] In some examples, the frame can comprise twelve axially extending columns, wherein six columns are configured as reinforced columns and six columns are configured as nonreinforced columns.

[0012] In some examples, each angled strut in a reinforced column is a reinforced strut.

[0013] In some examples, each reinforced column comprises reinforced struts in the first row of angled struts and the second row of angled struts, and wherein all of the angled struts in the one or more intermediate rows of angled struts are non-reinforced struts.

[0014] In some examples, all of the angled struts of the non-reinforced columns are nonreinforced struts.

[0015] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0016] FIG. 1 is a side view of a prosthetic heart valve, according to one example.

[0017] FIG. 2 is a side view of a frame of the prosthetic heart valve of FIG. 1.

[0018] FIG. 3 is a side view of a portion of the frame of FIG. 2, showing the portion of the frame in a straightened (non-annular) state.

[0019] FIG. 4 is a side view of an exemplary delivery apparatus configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site.

[0020] FIG. 5 is a side view of a portion of a frame for a prosthetic heart valve, according to one example.

[0021] FIG. 6 is a side view of a portion of a frame for a prosthetic heart valve, according to one example.

[0022] FIG. 7 is a side view of a portion of a frame for a prosthetic heart valve, according to one example.DETAILED DESCRIPTIONGeneral Considerations

[0023] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0024] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0025] 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 term “includes” means “comprises.” Further, the term “coupled” generally means 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.

[0026] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body).The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0027] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Overview of the Disclosed Technology

[0028] As introduced above, prosthetic heart valves can comprise a radially expandable and compressible annular frame and a plurality of leaflets attached to the frame. The frame can include a plurality of rows of cells formed by interconnected struts of the frame. The plurality of rows of cells can include a first row of cells arranged at an outflow end of the frame. In some examples, the cells of the first row of cells are elongated in an axial direction relative to cells of remaining rows of cells of the frame.

[0029] Additionally or alternatively, in some examples, in order to further increase a size of the cells of the first row of cells for increased coronary access following implantation, the cells of the first row of cell can be wider in a circumferential direction relative to cells of remaining rows of cells of the frame. For example, in some instances there may be one cell in the first row of cells for every two cells in each remaining row of cells (for example, due to the cells in the first row being twice as wide as the cells in the remaining rows of cells). As a result, cells of a second row of cells disposed adjacent to and connected to the first row of cells can include free apices that are unattached to (additional) struts defining the first row of cells.

[0030] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on the delivery apparatus. The prosthetic valve can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0031] In some instances, expansion of a prosthetic valve (e.g., using an inflatable balloon or other expandable member) can result in uneven expansion of the frame, resulting in some cells that are fully open while others are only partially opened thereby posing a risk ofimproper anchoring against the native anatomy, improper paravalvular leakage (PVL) sealing, and improper leaflet coaptation.

[0032] Described herein (see e.g., FIGS. 5-7 and the accompanying description thereof) are various examples of frames for prosthetic heart valves having thicker and / or wider struts in certain selected areas, for example, comprising columns of the frame that are adjacent the commissures. The columns including thicker / wider struts can be referred to as “reinforced columns,” the cells comprising thicker / wider struts as “reinforced cells,” and the struts themselves as “reinforced struts.” Such reinforced columns can provide additional stiffness at locations where such stiffness is beneficial during expansion (e.g., adjacent the commissures). The columns and cells formed solely or predominantly of the thinner struts (also referred to as “non-reinforced columns,” “non-reinforced cells,” and “non-reinforced struts”) offer less resistance during expansion of the frame, allowing for circumferentially- symmetric force distribution throughout the frame as the unreinforced cells expand first, followed by the reinforced cells. This allows the frame to assume a desired cylindrical configuration.Examples of the Disclosed Technology

[0033] FIG. 1 shows a prosthetic heart valve 100 (prosthetic valve), according to one example. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0034] 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. For example, in one example, 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 referenceherein. In another example, 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 another example, 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.

[0035] The prosthetic heart valve 100 can include a stent or frame 102, a valvular structure 104, and a perivalvular outer sealing member or outer skirt 106. The prosthetic heart valve 100 (and the frame 102) can have an inflow end 108 and an outflow end 110. The valvular structure 104 can be disposed on an interior of the frame 102 while the outer skirt 106 is disposed around an outer surface of the frame 102.

[0036] The valvular structure 104 can comprise a plurality of leaflets 112 (e.g., three leaflets, as shown in FIG. 1), collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement. The leaflets 112 can be secured to one another at their adjacent sides (e.g., commissure tabs) to form commissures 114 of the valvular structure 104. For example, each leaflet 112 can comprise opposing commissure tabs disposed on opposite sides of the leaflet 112 and a cusp edge portion extending between the opposing commissure tabs. The cusp edge portion of the leaflets 112 can have an undulating, curved scalloped shape, and can be secured directly to the frame 102 (e.g., by sutures). However, in alternate examples, the cusp edge portion of the leaflets 112 can be secured to an inner skirt which is then secured to the frame 102. In some examples, the leaflets 112 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.

[0037] In some examples, the outer skirt 106 can be an annular skirt. In some instances, the outer skirt 106 can comprise one or more skirt portions that are connected together and / or individually connected to the frame 102. The outer skirt 106 can comprise a fabric or polymeric material, such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc. In some instances, instead of having a relatively straight upper edge portion, as shown in FIG. 1, the outer skirt 106 can have an undulating upper edge portion that extends along and is secured to the angled struts 134. Examples of such outer skirts, as well as various other outer skirts, thatcan be used with the frame 102 can be found in PCT Publication No. WO2023 / 244612, which is incorporated by reference herein.

[0038] The frame 102 can be radially compressible and expandable between a radially compressed (or collapsed) configuration and a radially expanded configuration (the expanded configuration is shown in FIG. 1 ). The frame 102 is shown alone in FIG. 2 and a portion of the frame 102 in a straightened (non-annular) configuration is shown in FIG. 3.

[0039] The frame 102 can be made of any 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 102 (and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0040] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (e.g., the frame 102) include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 102 can comprise stainless steel. In some examples, the frame 102 can comprise cobalt-chromium. In some examples, the frame 102 can comprise nickel-cobalt- chromium. In some examples, the frame 102 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.

[0041] As shown in FIGS. 2 and 3, the frame 102 can comprise a plurality of interconnected struts 116 which form multiple rows of open cells 118 between the outflow end 110 and the inflow end 108 of the frame 102. In some examples, as shown in FIGS. 2 and 3, the frame 102 can comprise three rows of cells 118 with a first (upper in the orientation shown in FIGS. 2 and 3) row 120 of cells 118 disposed at the outflow end 110. The first row 120 comprises cells 118 that are elongated in an axial direction (relative to a central longitudinal axis 122 of the frame 102), as compared to cells 1 18 in the remaining rows of cells. For example, thecells 118 of the first row 120 of cells can have a longer axial length 124 (FIG. 3) than cells 118 in the remaining rows of cells, which can include a second row 126 of cells and a third row 128 of cells, the third row 128 of cells disposed at the inflow end 108 and the second row 126 of cells disposed between the first row 120 of cells 10 and the third row 128 of cells.

[0042] In some examples, as shown in FIG. 2, each row of cells comprises nine cells 1 18. Thus, in such examples, the frame 102 can be referred to as a nine-cell frame.

[0043] In alternate examples, the frame 102 can comprise more than three rows of cells (e.g., four or five) and / or more or less than nine cells per row. In some examples, the cells 118 in the first row 120 of cells may not be elongated compared to cells 118 in the remaining rows of cells of the frame 102 (the second row 126 of cells and the third row 128 of cells).

[0044] The interconnected struts 116 can include a plurality of angled struts 130, 132, 134, and 136 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the length of the frame 102 between the outflow end 110 and the inflow end 108. For example, the frame 102 can comprise a first row of angled struts 130 arranged end-to-end and extending circumferentially at the inflow end 108 of the frame; a second row of circumferentially extending, angled struts 132; a third row of circumferentially extending, angled struts 134; and a fourth row of circumferentially extending, angled struts 136 at the outflow end 110 of the frame 102.

[0045] The fourth row of angled struts 136 can be connected to the third row of angled struts 134 by a plurality of axially extending window struts 138 (or window strut portions) and a plurality of axial (or axially extending) struts 140. The axially extending window struts 138 (which can also be referred to as axial struts that include a commissure window) define commissure windows (e.g., open windows) 142 that are spaced apart from one another around the frame 102, in a circumferential direction, and which are adapted to receive a pair of commissure tabs of a pair of adjacent leaflets 112 arranged into a commissure (e.g., commissure 114 shown in FIG. 1). In some examples, the commissure windows 142 and / or the axially extending window struts 138 defining the commissure windows 142 can be referred to herein as commissure features or commissure supports, each commissure feature or support configured to receive and / or be secured to a pair of commissure tabs of a pair of adjacent leaflets.

[0046] One or more (for example, two, as shown in FIGS. 2 and 3) axial struts 140 can be positioned between, in the circumferential direction, two commissure windows 142 formedby the window struts 138. Since the frame 102 can include fewer cells per row (e.g., nine) and fewer axial struts 140 between each commissure window 142, as compared to some more traditional prosthetic heart valves, each cell 118 can have an increased width (in the circumferential direction), thereby providing a larger opening for blood flow and / or coronary access.

[0047] Each axial strut 140 and each window strut 138 extends from a location defined by the convergence of the lower ends (e.g., ends arranged inward of and farthest away from the outflow end 110) of two angled struts 136 (which can also be referred to as an upper strut junction or upper elongated strut junction) to another location defined by the convergence of the upper ends (e.g., ends arranged closer to the outflow end 110) of two angled struts 134 (which can also be referred to as a lower strut junction or lower elongate strut junction).Each axial strut 140 and each window strut 138 forms an axial side of two adjacent cells of the first row of cells 120.

[0048] In some examples, as shown in FIG. 3, each axial strut 140 can have a width 144 (FIG. 3) that is larger than a width of the angled struts 130, 132, 134, and 136. 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 longitudinal axis 122 of the frame 102). A “thickness” of a strut is measured between opposing locations on the radially facing inner surface or radially facing outer surface of a strut and is perpendicular to the width of the strut. In some examples, the width 144 of the axial struts 140 is 50-200%, 75-150%, or at least 100% larger than (e.g., double) the width of the angled struts of the frame 102.

[0049] By providing the axial struts 140 with the width 144 that is greater than the width of other, angled struts of the frame 102, a larger contact area is provided for when the leaflets 112 contact the wider axial struts 140 during systole, thereby distributing the stress and reducing the extent to which the leaflets 1 12 may fold over the axial struts 140, radially outward through the cells 118. As a result, a long-term durability of the leaflets 112 can be increased.

[0050] Since the cells 118 of the frame 102 can have a relatively large width compared to alternate prosthetic valves that have more than nine cells per row (as introduced above), the wider axial struts 140 can be more easily incorporated into the frame 102, without sacrificing open space for blood flow and / or coronary access.

[0051] Commissure tabs 115 of adjacent leaflets 112 can be secured together to form commissures 114 (FIG. 1). Each commissure 114 of the prosthetic heart valve 100 comprises two commissure tabs 115 paired together, one from each of two adjacent leaflets 112, and extending through a commissure window 142 of the frame 102. Each commissure 114 can be secured to the window struts 138 forming the commissure window 142.

[0052] The cusp edge portion (e.g., scallop edge) of each leaflet 112 can be secured to the frame 102 via one or more fasteners (e.g., sutures). In some examples, the cusp edge portion of each leaflet 112 can be secured directly to the struts of the frame 102 (e.g., angled struts 130, 132, and 134). For example, the cusp edge portions of the leaflets 112 can be sutured to the angled struts 130, 132, and 134 that generally follow the contour of the cusp edge portions of the leaflets 112.

[0053] In some examples, the cusp edge portion of the leaflets 112 can be secured to an inner skirt and the inner skirt can then be secured directly to the frame 102.

[0054] Various methods for securing the leaflets 112 to a frame, such as the frame 102, are disclosed in PCT Publication WO2023 / 086548, which is incorporated by reference herein in its entirety.

[0055] As shown in FIGS. 2 and 3, in some examples, one or more of or each of the axial struts 140 can comprise an inflow end portion 146 (e.g., an end portion that is closest to the inflow end 108) and an outflow end portion 148 that are widened relative to a middle portion 150 of the axial strut 140 (which can be defined by the width 144). In some instances, the inflow end portion 146 of the axial strut 140 can comprise an aperture 147. The apertures 147 can be configured to receive fasteners (e.g., sutures) for attaching soft components of the prosthetic heart valve 100 to the frame 102. For example, in some instances, the outer skirt 106 can be positioned around the outer surface of the frame 102 and an upper or outflow edge portion of the outer skirt 106 can be secured to the apertures 147 by fasteners 149 (e.g., sutures), as shown in FIG. 1.

[0056] The interconnected struts 116 can also comprise horizontal struts 182 that extend between adjacent cells 118 of a row of cells of the frame 102 (FIGS. 2 and 3). The horizontal struts 182 can extend in a circumferential direction and also be referred to as circumferentially extending struts 182. The horizontal struts 182 can connect angled struts of two adjacent rows of angled struts of the frame 102 to one another. For example, each horizontal strut 182 can connect to two angled struts of one row of struts (for example, struts134 shown in FIG. 3) and two angled struts in another, adjacent row of struts (for example, struts 132 shown in FIG. 3). As a result, an angled strut 184 extending between an axially extending window strut 138 and the horizontal strut 182 and an angled strut 186 extending between the horizontal strut 182 and another horizontal strut 182 disposed adjacent to the inflow end 108 of the frame 102 can be aligned along an angled line that can follow a scallop line of the leaflets (when the leaflets are attached to the frame 102). Thus, the horizontal struts 182 can allow the angled struts to follow a shape that more closely matches a shape of the scallop line of the leaflets when the frame 102 is in the radially expanded configuration (as shown in FIGS. 2 and 3). Additionally, the horizontal struts 182 can serve as spacers that can maintain a specified gap between the angled struts when the frame 102 is in the radially compressed configuration, thereby reducing a risk of pinching the leaflets between the struts in the radially compressed configuration.

[0057] The frame 102 can further comprise a plurality of apex regions 152 formed at the inflow end 108 and the outflow end 1 10, each apex region 152 extending and forming a junction between two angled struts 130 at the inflow end 108 or two angled struts 136 at the outflow end 110. As such, the apex regions 152 are spaced apart from one another, in a circumferential direction at the inflow end 108 and the outflow end 110.

[0058] Each apex region 152 can comprise an apex 154 (the highest or most outward extending, in an axial direction, point) and two thinned (or narrowed) strut portions 156, one thinned strut portion 156 extending from either side of the apex 154 to a corresponding, wider, angled strut 136 (at the outflow end 110) or angled strut 130 (at the inflow end 108) (FIG. 3). In this way, each of the apex regions 152 at the outflow end 110 can form a narrowed transition region between and relative to the two angled struts 136 extending from the corresponding apex region 152 and each of the apex regions 152 at the inflow end 108 can form a narrowed transition region between and relative to the two angled struts 130 extending from the corresponding apex region 152.

[0059] The thinned strut portions 156 of the apex regions 152 can have a width 158 that is smaller than a width 160 of the angled struts 130 or 136 (FIG. 3). In some examples, the width 158 can be a uniform width (e.g., along an entire length of the strut portion 156). In some examples, the width 158 of the thinned strut portions 156 can be from about 0.06 - 0.15 mm smaller than the width 160 of the angled struts 130 and / or 136.

[0060] The thinned strut portions 156 of the apex regions 152 can have a first length 162 (FIG. 3). In some examples, the first length 162 is in a range of 0.8-1.4 mm, 0.9-1.2 mm, 0.95-1.05 mm, or about 1.0 mm (e.g., ±0.03 mm). In alternate examples, the first length 162 is in a range of 0.3-0.7 mm, 0.4-0.6 mm, 0.45-0.55 mm, or about 0.5 mm (e.g., ±0.03 mm).

[0061] Thus, each outflow apex region 152 can include two thinned strut portions 156 having the first length 162, each extending from the apex 154, outward relative to a central longitudinal axis 164 of the cells 118. Thus, a total length of the apex region 152 can be two times the first length 162.

[0062] Each apex region 152 and two corresponding angled struts 136 at the outflow end 110 can form an outflow strut 166 and each apex region 152 and two corresponding angled struts 130 at the inflow end 108 can form an inflow strut 168.

[0063] Each outflow strut 166 and inflow strut 168 can have a length that includes an apex region 152 and the two angled struts 136 or 130 (or strut portions), respectively, on either side of the apex region 152. One half the total length of each outflow strut 166 and inflow strut 168 is shown in FIG. 3 as length 170, which extends from an end of one angled strut 136 or 130 to the central longitudinal axis 164. Thus, the length of each outflow strut 166 and inflow stmt 168 is two times length 170. In some examples, the length 170 for half of each inflow strut 168 can be different than the length 170 for half of each outflow strut 166.

[0064] In some instances, the length of each thinned strut portion 156 can be at least 25% of the length 170 of the corresponding half outflow strut 166 or inflow strut 168. Said another way, the length of each apex region 152 (a total length being two times the first length 162) can be at least 25% of the total length (two times length 170) of the outflow strut 166 or inflow stmt 168. In some examples, the length of each apex region 152 can be more than 25% of the total length of the corresponding outflow strut 166 or inflow strut 168, such as 25- 35%.

[0065] In some examples, each apex region 152 can comprise a curved, axially facing outer surface 172 and an arcuate or curved, axially facing inner depression 174 which forms the thinned strut portions 156. For example, the curved inner depression 174 can depress toward the curved outer surface 172 from an inner surface of the angled strut portions 156, thereby forming the smaller width thinned strut portions 156. Thus, the curved inner depressions 174 can be formed on a cell side of the apex region 152 (e.g., as opposed to the outside of the apex region 152).

[0066] In some examples, the curved outer surface 172 of each apex region 152 can form a single, continuous curve from one angled strut portion 156 on a first side of the apex region 152 to another angled strut portion 156 on an opposite, second side of the apex region 152 (for example, the curved outer surface 172 can have a constant convex curvature).

[0067] As used herein, “constant convex curvature” can refer to a continuously curved surface which is convex and which does not have an inflection point (no change in direction of the curvature).

[0068] Each apex region 152 can have a radius of curvature 176, along the curved outer surface 172 (e.g., in some instances, along an entirety or an entire length of the curved outer surface 172) (FIG. 3). In some instances, the radius of curvature 176 at the apex 154 and / or along the entire curved outer surface 172 of the apex region 152 can he greater than 1 mm. In some instances, the radius of curvature 176 can be in a range of 1-20 mm, 3-16 mm, or 8-14 mm. In some instances, the radius of curvature 176 can be greater than 10 mm. The radius of curvature 176 can be dependent on (and thus change due to changes in) the width 158 (e.g., the amount of reduction in width from the angled struts 130 or 136) and the first length 162 of the thinned strut portions 156.

[0069] Further, a height (an axial height) 178 of the apex regions 152, which can be defined in the axial direction from an outer surface of the two angled struts 130 or 136 to the curved outer surface 172 of the apex region 152 at the apex, can be the width 158 of the thinned strut portions 156 (FIG. 3). In this way, the height 178 of the apex regions 152 can be relatively small and not add much to the overall axial height of the radially expanded frame 102. Thus, the leaflets 112 secured to the frame 102 (FIG. 1) can be disposed close to the inflow end 108, thereby leaving a lar If ger open space at the outflow end 110 of the frame 102 that is not blocked by the leaflets 112.

[0070] In some examples, each of the apex region 152 can form an angle 180 between the two angled struts 130 or 136 extending from either side of the corresponding apex region 152 (FIG. 3). In some instances, the angle 180 can be in a range of 120 (not inclusive) to 140 degrees (e.g., such that the angle 180 is greater than 120 degrees and less than or equal to 140 degrees).

[0071] Additional details and examples of frames for prosthetic heart valves that include apex regions can be found in PCT Publication No. WO2022 / 226147, which is incorporated by reference herein in its entirety.

[0072] FIG. 4 shows a delivery apparatus 200, according to an example, that can be used to implant an expandable prosthetic heart valve (e.g., the prosthetic heart valve 100 of FIG. 1 and / or any of the other prosthetic heart valves described herein). In some examples, the delivery apparatus 200 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0073] The delivery apparatus 200 in the illustrated example of FIG. 4 is a balloon catheter comprising a handle 202 and a steerable, outer shaft 204 extending distally from the handle 202. The delivery apparatus 200 can further comprise an intermediate shaft 206 (which also may be referred to as a balloon shaft) that extends proximally from the handle 202 and distally from the handle 202, the portion extending distally from the handle 202 also extending coaxially through the outer shaft 204. Additionally, the delivery apparatus 200 can further comprise an inner shaft 208 extending distally from the handle 202 coaxially through the intermediate shaft 206 and the outer shaft 204 and proximally from the handle 202 coaxially through the intermediate shaft 206.

[0074] The outer shaft 204 and the intermediate shaft 206 can be configured to translate (e.g., move) longitudinally, along a central longitudinal axis 220 of the delivery apparatus 200, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient’s body.

[0075] The intermediate shaft 206 can include a proximal end portion 210 that extends proximally from a proximal end of the handle 202, to an adaptor 212. A rotatable knob 214 can be mounted on the proximal end portion 210 and can be configured to rotate the intermediate shaft 206 around the central longitudinal axis 220 and relative to the outer shaft 204.

[0076] The adaptor 212 can include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 240 can be fluidly coupled to an inner lumen of the intermediate shaft 206.

[0077] The intermediate shaft 206 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 204 when a distal end of the outer shaft 204 is positioned away from an inflatable balloon 218 of the delivery apparatus 200. A distal end portion of the inner shaft 208 can extend distally beyond the distal end portion of the intermediate shaft 206.

[0078] The balloon 218 can be coupled to the distal end portion of the intermediate shaft 206.

[0079] In some examples, a distal end of the balloon 218 can be coupled to a distal end of the delivery apparatus 200, such as to a nose cone 222 (as shown in FIG. 4), or to an alternate component at the distal end of the delivery apparatus 200 (e.g., a distal shoulder). An intermediate portion of the balloon 218 can overlay a valve mounting portion 224 of a distal end portion of the delivery apparatus 200 and a distal end portion of the balloon 218 can overly a distal shoulder 226 of the delivery apparatus 200. The valve mounting portion 224 and the intermediate portion of the balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 4, a prosthetic heart valve 250 (which can be one of the prosthetic valves described herein) can be mounted around the balloon 218, at the valve mounting portion 224 of the delivery apparatus 200.

[0080] The balloon shoulder assembly, including the distal shoulder 226, is configured to maintain the prosthetic heart valve 250 (or other medical device) at a fixed position on the balloon 218 during delivery through the patient’s vasculature.

[0081] The outer shaft 204 can include a distal tip portion 228 mounted on its distal end. The outer shaft 204 and the intermediate shaft 206 can be translated axially relative to one another to position the distal tip portion 228 adjacent to a proximal end of the valve mounting portion 224, when the prosthetic valve 250 is mounted in the radially compressed state on the valve mounting portion 224 (as shown in FIG. 4) and during delivery of the prosthetic valve to the target implantation site. As such, the distal tip portion 228 can be configured to resist movement of the prosthetic valve 250 relative to the balloon 218 proximally, in the axial direction, relative to the balloon 218, when the distal tip portion 228 is arranged adjacent to a proximal side of the valve mounting portion 224.

[0082] An annular space can be defined between an outer surface of the inner shaft 208 and an inner surface of the intermediate shaft 206 and can be configured to receive fluid from a fluid source via the second port 240 of the adaptor 212. The annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 208 and an inner surface of the balloon 218. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the balloon 218 and radially expand and deploy the prosthetic valve 250.

[0083] An inner lumen of the inner shaft can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 200 to the target implantation site.

[0084] The handle 202 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 200. In the illustrated example, for example, the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 202 through the outer shaft 204 and has a distal end portion affixed to the outer shaft 204 at or near the distal end of the outer shaft 204. Rotating the knob 260 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 200. Further details on steering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0085] The handle 202 can further include an adjustment mechanism 261 including an adjustment member, such as the illustrated rotatable knob 262, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 278. The adjustment mechanism 261 is configured to adjust the axial position of the intermediate shaft 206 relative to the outer shaft 204 (e.g., for fine positioning at the implantation site). Further details on the delivery apparatus 200 can be found in PCT Publication No. WO2022 / 046585 which is incorporated by reference herein in its entirety.

[0086] FIGS. 5-6 illustrate another exemplary frame 300 for a prosthetic heart valve. In some examples, the frame 300 can be used in lieu of frame 102 in the prosthetic heart valve 100 of FIG. 1. Though only a portion of frame 300 is shown in FIGS. 5-6, it should be understood that frame 300 is an annular structure similar to frame 102. FIGS. 5-6 represent a one- third section of the frame 300. Thus, in some examples, a complete frame 300 can comprise three such sections connected side-by-side around the circumference of the frame. A prosthetic valve implementing frame 300 can be implanted using any of the methods, techniques, and / or delivery apparatuses described herein. Suitable materials used to form the frame are described above with reference to frame 102.

[0087] In some examples, the frame 300 can provide a more even expansion during deployment of the prosthetic heart valve incorporating the frame 300. For example, referring to FIGS. 5-6, in some examples, selected areas of the frame 300 can comprise wider struts(referred to herein as “reinforced struts”), thereby modifying the radial distribution of force around the circumference of the frame 300 during expansion to result in a more even force distribution. In such a configuration, the non-reinforced struts (i.e., the struts with a narrower width) offer less resistance and expand first, followed by the reinforced struts.

[0088] 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 (e.g., relative to a central longitudinal axis of the frame). A “thickness” of a strut is measured between opposing locations on the radially facing inner surface or radially facing outer surface of a strut and is perpendicular to the width of the strut. The thickness of the struts is not visible in the views shown in FIGS. 5-7 and extends in a direction into the plane of the page.

[0089] Referring to FIG. 5, the frame 300 can comprise a plurality of interconnected struts 302 that form open cells 304 disposed in multiple rows 306 between the outflow end 308 and the inflow end 310. In some examples, such as shown in FIGS. 5-6, the frame 300 can comprise three circumferentially extending rows 306 of cells 304 with a first (upper in the orientation shown in FIGS. 5-6) row 306a of cells disposed at the outflow end 308. The first row 306a of cells comprises cells 304a that are elongated in an axial direction (relative to a central longitudinal axis of the frame), compared to the cells 304 in the remaining rows of cells. For example, cells 304a in the first row 306a of cells have a longer axial length Li than cells 304b, 304c in the remaining rows of cells, which can include a second row 360h of cells, and a third row 306c of cells.

[0090] In some examples, such as shown in FIGS. 5-6, each row 306 of cells comprises nine cells 304. Thus, the frame 300 can be referred to as a nine-cell frame. In other examples, the frame 300 can have a greater or fewer number of circumferentially extending rows 306 of cells 304 and / or a greater or fewer number of cells 304 in each row. For example, in some instances the frame 300 can have four rows 306 of cells 304, each comprising twelve cells. In such instances the frame 300 can be referred to as a twelve-cell frame.

[0091] In some examples, the cells 304a of the first row 306a may not be elongated relative to the other rows and / or the cells of the other rows (e.g., the second or third rows 306b, 306c) may be elongated relative to the remaining rows.

[0092] The interconnected struts 302 can include a plurality of angled struts 312 and a plurality of axially extending struts 314. The plurality of angled struts 312 are arranged in aplurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the length of the frame 300 between the outflow end 308 and the inflow end 310. For example, the frame 300 can comprise a first row of angled struts 312a arranged end-to-end and extending circumferentially at the outflow end 308 of the frame (also referred to as the “outflow angled struts” 312a); a second row of circumferentially extending, angled struts 312b; a third row of circumferentially extending, angled struts 312c; and a fourth row of circumferentially extending, angled struts 312d at the inflow end 310 of the frame 300 (also referred to as the “inflow angled struts” 312d). The second and third rows of angled struts can be referred to as the “intermediate angled struts” 312b, 312c).

[0093] The first row of angled struts 312a can be connected to the second row of angled struts 312b by a plurality of axially extending struts 314 (also called “axial struts”) including a plurality of axially extending commissure support posts in the form of axially extending window struts (or window strut portions) 316. The axially extending window struts 316 (which can also be referred to as “axial struts that include a commissure window”) define commissure windows 318 (e.g., open windows) that are spaced apart from one another around the frame 300, in a circumferential direction, and which are adapted to receive a pair of commissure tabs of a pair of adjacent leaflets arranged into a commissure. In some examples, the commissure windows 318 and / or the axially extending window struts 316 defining the commissure windows 318 can be referred to herein as commissure features or commissure supports, each commissure feature or support configured to receive and / or be secured to a pair of commissure tabs of a pair of adjacent leaflets.

[0094] One or more (for example, two, as shown in FIGS. 5-6) axial struts 314 can be positioned between, in the circumferential direction, two commissure windows 318 formed by the window struts 316. Each axial strut 314 and each window strut 316 extends from a location defined by the convergence of the lower ends (e.g., ends arranged inward of and farthest away from the outflow end 308) of two angled struts 312 (which can also be referred to as an upper strut junction or upper elongated strut junction) to another location defined by the convergence of the upper ends (e.g., ends arranged closer to the outflow end 308) of two angled struts 312 (which can also be referred to as a lower strut junction or lower elongate strut junction). Each axial strut 314 and each window strut 316 forms an axial side of two adjacent cells of the first row 306a of cells.

[0095] In some examples, such as shown in FIGS. 5 and 6, certain portions of the frame 300 can be reinforced to distribute expansion forces more evenly to the frame 300 during radialexpansion of the prosthetic valve. For example, selected struts 302 of the frame, referred to herein as reinforced struts 320 can have a width 322 wider than a width 324 of the nonreinforced struts 326. For example, the reinforced struts 320 can have a width 322 between about 0.3 mm to about 1.0 mm, between about 0.4 mm and about 0.9 mm, between about 0.5 mm and about 0.8 mm. The non-reinforced struts 326 can have a width 324 between about 0.1 mm and about 0.6 mm less than the width 322 of the reinforced struts 320. For example, the non-reinforced struts 326 can have a width 324 between about 0.2 mm to about 0.5 mm, between about 0.3 mm and about 0.45 mm, between about 0.35 mm and about 0.4 mm. FIGS. 5 and 6 show the reinforced struts 320 with a pattern added for purposes of illustration. The pattern is added to distinguish the reinforced struts 320 from the non-reinforced struts 326 and does not represent actual surface ornamentation.

[0096] In some examples, the frame 300 can be formed through laser-cutting, allowing the reinforced and non-reinforced struts 320, 326 to be cut to a selected width.

[0097] In the configuration shown in FIGS. 5 and 6, the frame 300 can be divided into a plurality of axially extending columns 328, each comprising one or more cells, wherein the one or more cells are arrayed along the length of the frame (the length extending from the inflow end to the outflow end). For purposes of illustration, the columns 328 have been delineated by axes A extending through the axially extending struts 314, including the axially extending window struts 316. In some examples, such as shown in FIGS. 5 and 6, each column 328 can comprise a first cell 304a disposed at the outflow end portion 308 of the frame 300 and a second cell 304c disposed at the inflow end portion 310. One or more struts 302 of selected columns 328 can be configured as reinforced struts 320.

[0098] In some examples, such as shown in FIG. 5, all of the angled struts 312 of one or more selected columns 328 can be configured as reinforced struts 320 with a width 322. In other examples, such as shown in FIG. 6 and discussed further below, only selected struts 302 of selected columns 328 are configured as reinforced struts 320. Columns 328 that include one or more reinforced struts 320 can be referred to as “reinforced columns” and columns that do not include any reinforced struts 320 can be referred to as “non-reinforced columns.”

[0099] As shown in FIGS. 5 and 6, in some examples, each adjacent pair of axially extending window struts 316 can comprise three columns 328 between them, a first column 328a, a second column 328b, and a third column 328c. The second column 328b can be disposed between the first and third columns 328a, 328c. In some examples, such as the illustratedexamples, the second column 328b can comprise non-reinforced struts 326. The first and third columns 328a, 328c can be configured as reinforced columns each comprising one or more reinforced struts 320. This pattern of columns 328 can continue symmetrically about the circumference of the frame such that the nine-cell frame 300 comprises three columns 328 without reinforced struts 320 each disposed 120 degrees from one another and six columns 328 with reinforced struts 320.

[0100] Referring to FIG. 5, the axially extending window struts 316 can have a first reinforced column 328a disposed circumferentially adjacent a first side thereof, and a second reinforced column 328c disposed circumferentially adjacent a second side thereof. In the illustrated example, each of the angled struts 312 of the reinforced columns 328a, 328c is a reinforced strut 320. However, in other examples, the reinforced columns 328a, 328c can comprise any pattern of reinforced struts 320 provided that the pattern is circumferentially symmetrical.

[0101] In other examples, for example, the second column 328b can be a reinforced column comprising one or more reinforced struts 320 and the first and third columns 328a, 328c can be non-reinforced columns comprising only non-reinforced struts 326. In such examples, the reinforced columns 328b can each be disposed 120 degrees from one another about the circumference of the frame 300. Any other pattern of reinforced and non-reinforced columns can be implemented, provided that the pattern is circumferentially symmetric.

[0102] In some examples, selected axially extending struts 314 and / or window struts 316 can also be reinforced to have a width greater than a width of the non-reinforced axially extending struts. However, in other examples, the axially extending struts 314 and / or window struts 316 can be non-reinforced struts.

[0103] The width of the reinforced struts 320 increases the stiffness of the cells 304 comprising the reinforced struts 320 such that during radial expansion of the frame 300 the columns 328b comprising non-reinforced struts 326 expand more quickly and with less force applied than the columns 328a, 328c comprising reinforced struts 320. The positioning of the columns 328b of non-reinforced struts about the circumference of the frame 300 aids in the symmetrical expansion of the frame 300 such that it retains a cylindrical configuration throughout the expansion process.

[0104] In some examples, the non-reinforced struts 326 can be thinner than the reinforced struts 320 only in selected areas (also referred as “localized thinning”). This helps the non-reinforced struts 326 to maintain pliability / flexibility during expansion while helping such struts 326 remain structurally sound when the frame is fully radially expanded.

[0105] Similarly to frame 102, the frame 300 can further comprise a plurality of apex regions 330 formed at the inflow end 310 and the outflow end 308, each apex region 330 extending and forming a junction between two angled struts 312 at the inflow end 310 or two angled struts 312 at the outflow end 308. As such, the apex regions 330 are spaced apart from one another, in a circumferential direction at the inflow end 310 and the outflow end 308.

[0106] Each apex region 330 can comprise an apex 332 (the highest or most outward extending, in an axial direction, point) and two thinned (or narrowed) strut portions 334, one thinned strut portion 334 extending from either side of the apex 332 to a corresponding, wider, angled strut 312a (at the outflow end 308) or angled strut 312d (at the inflow end 310). In this way, each of the apex regions 330 at the outflow end 308 can form a narrowed transition region between and relative to the two angled struts 312a extending from the corresponding apex region 332 and each of the apex regions 330 at the inflow end 310 can form a narrowed transition region between and relative to the two angled struts 312d extending from the corresponding apex region 330.

[0107] The thinned strut portions 334 of the apex regions 330 can have a width 336 that is smaller than a width 322 or 324 of the angled struts 312a or 312d. In some examples, the width can be a uniform width (e.g., along an entire length of the strut portion). In some examples, the width of the thinned strut portions 334 can be from about 0.06 - 0.15 mm smaller than the width 322 or 324 of the angled struts 312a and / or 312d.

[0108] In some examples, selected apices can comprise reinforced thinned strut portions 334 having a width 338. While the reinforced thinned strut portions 334 still have a width 338 smaller than a width of the reinforced angled struts 320, their width is greater than the width 336 of the non-reinforced thinned strut portions 334. For example, in the configuration illustrated in FIG. 5, the columns 328a, 328c adjacent to the axially extending window struts 316 can comprise reinforced thinned strut portions 332 and the second column 328b can comprise non-reinforced thinned strut portions 332.

[0109] Additional details and examples of frames for prosthetic heart valves that include apex regions can be found in PCT Publication No. WO2022 / 226147, which is incorporated by reference herein in its entirety.

[0110] Referring now to FIG. 6, in some examples, only the inflow and / or outflow angled struts 312a, 312d of selected columns 328 are configured as reinforced struts 320. For example, as shown in FIG. 6, only the inflow and outflow angled struts 312a, 312d of the columns 328a, 328c circumferentially adjacent the axially extending window struts 316 are reinforced struts 320. In such a configuration, each of the inflow and outflow angled struts 312a, 312d of the columns 328a, 328c has a width 322 greater than a width 324 of the inflow and outflow angled struts 312a, 312d of the central column 328b. In some examples, the width 322 of the reinforced inflow angled struts 320 and the reinforced outflow angled struts 320 can be the same or approximately the same. In other examples, the reinforced inflow angled struts 320 can have a width greater than a width of the reinforced outflow angled struts 320, or vice versa.

[0111] The width of the reinforced struts 320 increases the stiffness of the inflow and / or outflow angled struts 312a, 312d, while allowing the non-reinforced struts 326 to remain flexible and / or pliable. This configuration can facilitate cylindrical expansion of the frame 300 by facilitating synchronized expansion of the inflow and / or outflow end portions 308, 310. This can prevent the frame 300 from uneven expansion and / or from assuming an undesired hourglass or V-shaped frame configuration.

[0112] In some examples, the reinforced columns can include any configuration of reinforced struts and non-reinforced struts, wherein each reinforced column has the same configuration of reinforced struts and non-reinforced struts; that is, each reinforced column has the same number of the reinforced struts and non-reinforced struts and the same placement of the reinforced struts and non-reinforced struts. For example, each reinforced column can have only struts 312a configured as reinforced struts, only struts 312b configured as reinforced struts, only struts 312c configured as reinforced struts, only struts 312d configured as reinforced struts, or any combination thereof.

[0113] FIG. 7 illustrates a portion of another exemplary frame 400 for a prosthetic heart valve. In some examples, the frame 400 can be used in lieu of frame 102 in the prosthetic heart valve 100 of FIG. 1. Frame 400 can be similar to frame 300 (e.g., comprising the same materials and structures except where indicated otherwise), except that frame 400 can comprise a greater number of circumferentially extending rows 406 of cells 404 (e.g., four rows), with a greater number of cells 404 (e.g., twelve cells) in each row, thereby defining a greater number of axially extending columns 428. Frame 400 can thus be referred to as a twelve-cell frame. A prosthetic valve implementing frame 400 can be implanted using any ofthe methods, techniques, and / or delivery apparatuses described herein. Though FIG. 7 shows a portion of the frame in a straightened (non-annular configuration) it should be understood that the frame 400 can assume an annular configuration.

[0114] As shown in FIG. 7, the frame 400 can comprise a plurality of interconnected struts 402 that form open cells 404 disposed in multiple rows 406 between the outflow end 408 and the inflow end 410. The frame 400 can comprise four circumferentially extending rows 406 of cells with a first (upper in the orientation shown in FIG. 7) row of cells 406a disposed at the outflow end 408. The first row 406a of cells can comprise cells 404a that are elongated in an axial direction (relative to a central longitudinal axis of the frame), compared to the cells 404 in the remaining rows 406b-406d, which can include a second row 406b of cells, a third row 406c of cells, and a fourth row 406d of cells.

[0115] The interconnected struts 402 can include a plurality of angled struts 412 and a plurality of axially extending struts 414. The angled struts 412 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the length of the frame 400 between the outflow end 408 and the inflow end 410. For example, the frame 400 can comprise a first row of angled struts 412a arranged end-to-end and extending circumferentially at the outflow end 408 of the frame (also referred to as the “outflow angled struts” 412a); a second row of circumferentially extending, angled struts 412b; a third row of circumferentially extending, angled struts 412c; a fourth row of circumferentially extending, angled struts 412d; and a fifth row of circumferentially extending, angled struts 412e at the inflow end 410 of the frame 400 (also referred to as the “inflow angled struts” 412e). The second through fourth rows of angled struts can be referred to as the “intermediate angled struts” 412b-412d).

[0116] The first row of angled struts 412a can be connected to the second row of angled struts 412b by a plurality of axially extending struts 414 some of which are configured as axially extending commissure support posts in the form of axially extending window struts 416 (or window strut portions). The axially extending window struts 416 (which can also be referred to as axial struts that include a commissure window) define commissure windows (e.g., open windows) 418 that are spaced apart from one another around the frame 400, in a circumferential direction, and which are adapted to receive a pair of commissure tabs of a pair of adjacent leaflets arranged into a commissure. In some examples, the commissure windows 418 and / or the axially extending window struts 416 defining the commissure windows 418 can be referred to herein as commissure features or commissure supports, eachcommissure feature or support configured to receive and / or be secured to a pair of commissure tabs of a pair of adjacent leaflets.

[0117] As shown in FIG. 7, the frame 400 can be divided into a plurality of axially extending columns 428. For purposes of illustration, the columns 328 have been delineated by axes B extending through the axially extending struts 414, including the axially extending window struts 416. One or more struts 402 of selected columns 428 can be configured as reinforced struts 420. Columns 428 that include reinforced struts 420 can be referred to as “reinforced columns.’" In the illustrated example, all of the angled struts 402 of the reinforced columns are configured as reinforced struts 420.

[0118] Similarly to reinforced struts 320, the reinforced struts 420 can have a width 422 wider than a width 424 of the non-reinforced struts 426. For example, the reinforced struts 420 can have a width 422 between about 0.3 mm to about 1.0 mm, between about 0.4 mm and about 0.9 mm, between about 0.5 mm and about 0.8 mm. The non-reinforced struts 426 can have a width 424 between about 0.1 mm and about 0.6 mm less than the width 422 of the reinforced struts 420. For example, the non-reinforced struts 426 can have a width 424 between about 0.2 mm to about 0.5 mm, between about 0.3 mm and about 0.45 mm, between about 0.35 mm and about 0.4 mm. FIG. 7 shows the reinforced struts 420 with a pattern added for purposes of illustration. The pattern is added to distinguish the reinforced struts 420 from the non-reinforced struts 426 and does not represent actual surface ornamentation.

[0119] As shown in FIG. 7, in some examples, each adjacent pair of axially extending window struts 416 can comprise four columns 428 between them, a first column 428a, a second column 428b, a third column 428c, and a fourth column 428d. The second and third columns 428b, 428c can be disposed between the first and fourth columns 428a, 428d and can comprise non-reinforced struts 426. The first and fourth columns 428a, 428b can be configured as reinforced columns each comprising one or more reinforced struts 420. This pattern of columns 428 can continue symmetrically about the circumference of the frame such that the twelve-cell frame 400 comprises six columns 428 with reinforced struts 420 and six columns without reinforced struts 420 disposed in a circumferentially symmetrical pattern about the frame 400. As shown in FIG. 7, this results in a configuration wherein each axially extending window strut 416 has a reinforced column circumferentially adjacent the strut 416 on either side.

[0120] In some examples, for example, the second and third columns 428b, 428c can be reinforced columns and the first and fourth columns 428a, 428d can be non-reinforced columns. In some examples, any other pattern of reinforced and non-reinforced columns can be implemented, provided that the pattern is circumferentially symmetric.

[0121] In some examples, the reinforced columns 428 can include any configuration of reinforced struts and non-reinforced struts, wherein each reinforced column has the same configuration of reinforced struts and non-reinforced struts; that is, each reinforced column has the same number of the reinforced struts and non-reinforced struts and the same placement of the reinforced struts and non-reinforced struts. For example, each reinforced column can have only struts 412a configured as reinforced struts, only struts 412b configured as reinforced struts, only struts 412c configured as reinforced struts, only struts 412d configured as reinforced struts, only struts 412e configured as reinforced struts, or any combination thereof.

[0122] Additional details and examples of frames for prosthetic heart valves that include reinforced struts can be found in U.S. Provisional Application 63 / 592,864 filed October 24, 2023, and International Application No. PCT / US2023 / 031121, which are incorporated by reference herein in their entirety.Delivery Techniques

[0123] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial I-sternotomy or right parasternal mini- thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0124] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0125] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0126] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0127] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approachesare not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

[0128] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, 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 system, 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, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.

[0129] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with the body parts, tissue, etc. being simulated), etc.Additional Examples of the Disclosed Technology

[0130] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0131] Example 1. A prosthetic heart valve, comprising: a radially expandable and compressible annular frame comprising: a plurality of interconnected angled struts defining a plurality of axially extending columns arranged circumferentially around the frame, the plurality of interconnected angled struts arranged to form a first row of angled struts at a first end of the frame, one or more intermediate rows of angled struts, and a second row of angled struts at a second end of the frame, and wherein the plurality of angled struts comprises a plurality of reinforced struts and a plurality of non-reinforced struts, and wherein the plurality of reinforced struts each have a width greater than a width of each of the non-reinforced struts; wherein a first set of columns of the plurality of axially extending columns are configured as reinforced columns comprising one or more reinforced struts; and wherein thereinforced columns are disposed in a circumferentially symmetric pattern about the circumference of the frame.

[0132] Example 2. The prosthetic heart valve of any example herein, particularly example 1 , wherein a second set of columns of the plurality of axially extending columns are configured as non-reinforced columns that do not have any reinforced struts.

[0133] Example 3. The prosthetic heart valve of any example herein, particularly any one of examples 1 or 2, wherein the frame comprises nine axially extending columns, wherein six columns are configured as reinforced columns and three columns are configured as nonreinforced columns, and wherein the non-reinforced columns are disposed 120 degrees from one another about the circumference of the frame.

[0134] Example 4. The prosthetic heart valve of any example herein, particularly any one of examples 1 or 2, wherein the frame comprises nine axially extending columns, wherein three columns are configured as reinforced columns, and wherein the three reinforced columns are disposed 120 degrees from one another about the circumference of the frame.

[0135] Example 5. The prosthetic heart valve of any example herein, particularly any one of examples 1 or 2, wherein the frame comprises twelve axially extending columns, wherein six columns are configured as reinforced columns and six columns are configured as nonreinforced columns.

[0136] Example 6. The prosthetic heart valve of any example herein, particularly any one of examples 1-5, wherein the width of each of the reinforced struts is between 0.3 mm and 1.0 mm.

[0137] Example 7. The prosthetic heart valve of any example herein, particularly example 6, wherein the width of each of the non-reinforced struts is between 0.1 mm and 0.6 mm less than the width of each of the reinforced struts.

[0138] Example 8. The prosthetic heart valve of any example herein, particularly any one of examples 1-7, wherein the width of each of the non-reinforced struts is between 0.2 mm and 0.5 mm.

[0139] Example 9. The prosthetic heart valve of any example herein, particularly any one of examples 1-8, wherein the frame further comprises a plurality of axially extending struts that extend between the first row of angled struts at the first end of the frame and a first row of the one or more intermediate rows of angled struts.

[0140] Example 10. The prosthetic heart valve of any example herein, particularly example 9, wherein a set of the plurality of axially extending struts are axially extending commissuresupport posts, and wherein a respective reinforced column is disposed circumferentially adjacent a first side edge of each axially extending commissure support post.

[0141] Example 11. The prosthetic heart valve of any example herein, particularly example 10, wherein the respective reinforced column is a first reinforced column and wherein a second reinforced column is disposed circumferentially adjacent a second side edge of each axially extending commissure support post.

[0142] Example 12. The prosthetic heart valve of any example herein, particularly any one of examples 1 -1 1 , further comprising a valvular structure disposed within and coupled to the annular frame.

[0143] Example 13. The prosthetic heart valve of any example herein, particularly any one of examples 1-12, wherein each angled strut in a reinforced column is a reinforced strut.

[0144] Example 14. The prosthetic heart valve of any example herein, particularly any one of examples 1-12, wherein each reinforced column comprises reinforced struts in the first row of angled struts and the second row of angled struts, and wherein the one or more intermediate rows of angled struts are non-reinforced struts.

[0145] Example 15. The prosthetic heart valve of any example herein, particularly any one of examples 1-14, wherein the first row of struts form pairs of angled struts, wherein the struts of each part of angled struts are connected together at their adjacent ends by an outflow apex region, and wherein the outflow apex region has a narrowed thickness relative to each strut of the pair of angled struts.

[0146] Example 16. A prosthetic heart valve, comprising: a radially expandable and compressible annular frame comprising: a plurality of interconnected angled struts defining a plurality of axially extending columns arranged circumferentially around the frame, the plurality of interconnected angled struts arranged to form a first row of angled struts at a first end of the frame, one or more intermediate rows of angled struts, and a second row of angled struts at a second end of the frame, and a plurality of axially extending struts that extend between the first row of angled struts at the first end of the frame and a first row of the one or more intermediate rows of angled struts; and a plurality of leaflets disposed within the frame and secured together at their adjacent sides to form commissures; wherein a set of the plurality of axially extending struts are commissure support posts; wherein the plurality of angled struts comprises a plurality of reinforced struts and a plurality of non-reinforced struts, and wherein each of the plurality of reinforced struts have a width greater than a width of each of the non-reinforced struts; wherein the axially extending columns comprise one or more reinforced columns comprising one or more of the plurality of reinforced struts;wherein the one or more reinforced columns are each disposed circumferentially adjacent a respective axially extending commissure support post; and wherein the commissures are secured to the commissure support posts of the frame.

[0147] Example 17. The prosthetic heart valve of any example herein, particularly example16, wherein the plurality of axially extending columns comprises nine axially extending columns.

[0148] Example 18. The prosthetic heart valve of any example herein, particularly example17, wherein there are three axially extending columns between one of the commissure support posts and another one of the commissure support posts, and wherein two of the three axially extending columns are reinforced columns.

[0149] Example 19. The prosthetic heart valve of any example herein, particularly example 16, wherein the plurality of axially extending columns comprises twelve columns.

[0150] Example 20. The prosthetic heart valve of any example herein, particularly example 19, wherein there are four axially extending columns between one of the commissure support posts and another one of the commissure support posts, and wherein two of the four axially extending columns are reinforced columns.

[0151] Example 21. The prosthetic heart valve of any example herein, particularly any one of examples 16-20, wherein each angled strut in a reinforced column is a reinforced strut.

[0152] Example 22. The prosthetic heart valve of any example herein, particularly any one of examples 16-20, wherein each reinforced column comprises reinforced struts in the first row of angled struts and the second row of angled struts, and wherein all of the angled struts in the one or more intermediate rows of angled struts are non-reinforced struts.

[0153] Example 23. The prosthetic heart valve of any example herein, particularly any one of examples 16-22, wherein the plurality of axially extending columns comprises a plurality of reinforced columns and a plurality of non-reinforced columns, wherein there is at least one non-reinforced column between two reinforced columns.

[0154] Example 24. The prosthetic heart valve of any example herein, particularly example 23, wherein all of the angled struts of the non-reinforced columns are non-reinforced struts.

[0155] Example 25. The prosthetic heart valve of any example herein, particularly any one of examples 23 or 24, wherein each reinforced column has the same configuration of reinforced struts and non-reinforced struts.

[0156] Example 26. A prosthetic heart valve, comprising: a radially expandable and compressible annular frame comprising: a plurality of interconnected angled struts defining a plurality of axially extending columns arranged circumferentially around the frame, eachcolumn extending from an inflow end of the frame to an outflow end of the frame, the plurality of interconnected angled struts arranged to form an outflow row of angled struts at the outflow end of the frame, one or more intermediate rows of angled struts, and an inflow row of angled struts at the inflow end of the frame, and wherein the plurality of angled struts comprises a plurality of reinforced struts and a plurality of non-reinforced struts, and wherein the plurality of reinforced struts each have a width greater than a width of each of the nonreinforced struts; wherein selected columns of the plurality of axially extending columns are configured as reinforced columns comprising one or more reinforced struts; and wherein the reinforced columns are disposed in a circumferentially symmetric pattern about the circumference of the frame.

[0157] Example 27. The prosthetic heart valve of any example herein, particularly example 26, wherein each angled strut in a reinforced column is a reinforced strut.

[0158] Example 28. The prosthetic heart valve of any example herein, particularly example 26, wherein each reinforced column comprises only reinforced struts in the inflow row of angled struts and the outflow row of angled struts, and wherein all of the angled struts in the one or more intermediate rows of angled struts are non-reinforced struts.

[0159] Example 29. The prosthetic heart valve of any example herein, wherein the prosthetic heart valve is sterilized.

[0160] Example 30. A method of sterilizing any of the prosthetic heart valves described herein.

[0161] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. The reinforced columns and / or reinforced struts can be disposed about the frame in any pattern, provided that the pattern is circumferentially symmetric.

[0162] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

Claims:

1. A prosthetic heart valve, comprising: a radially expandable and compressible annular frame comprising: a plurality of interconnected angled struts defining a plurality of axially extending columns arranged circumferentially around the frame, the plurality of interconnected angled struts arranged to form a first row of angled struts at a first end of the frame, one or more intermediate rows of angled struts, and a second row of angled struts at a second end of the frame, and wherein the plurality of angled struts comprises a plurality of reinforced struts and a plurality of non-reinforced struts, and wherein the plurality of reinforced struts each have a width greater than a width of each of the non-reinforced struts; wherein a first set of columns of the plurality of axially extending columns are configured as reinforced columns comprising one or more reinforced struts; and wherein the reinforced columns are disposed in a circumferentially symmetric pattern about the circumference of the frame.

2. The prosthetic heart valve of claim 1, wherein a second set of columns of the plurality of axially extending columns are configured as non-reinforced columns that do not have any reinforced struts.

3. The prosthetic heart valve of any one of claims 1 or 2, wherein the frame comprises nine axially extending columns, wherein six columns are configured as reinforced columns and three columns are configured as non-reinforced columns, and wherein the nonreinforced columns are disposed 120 degrees from one another about the circumference of the frame.

4. The prosthetic heart valve of any one of claims 1 or 2, wherein the frame comprises nine axially extending columns, wherein three columns are configured as reinforced columns, and wherein the three reinforced columns are disposed 120 degrees from one another about the circumference of the frame.

5. The prosthetic heart valve of any one of claims 1 or 2, wherein the frame comprises twelve axially extending columns, wherein six columns are configured as reinforced columns and six columns are configured as non-reinforced columns.

6. The prosthetic heart valve of any one of claims 1-5, wherein the width of each of the reinforced struts is between 0.3 mm and 1.0 mm.

7. The prosthetic heart valve of claim 6, wherein the width of each of the nonreinforced struts is between 0.1 mm and 0.6 mm less than the width of each of the reinforced struts.

8. The prosthetic heart valve of any one of claims 1-7, wherein the width of each of the non-reinforced struts is between 0.2 mm and 0.5 mm.

9. The prosthetic heart valve of any one of claims 1-8, wherein the frame further comprises a plurality of axially extending struts that extend between the first row of angled struts at the first end of the frame and a first row of the one or more intermediate rows of angled struts.

10. The prosthetic heart valve of claim 9, wherein a set of the plurality of axially extending struts are axially extending commissure support posts, and wherein a respective reinforced column is disposed circumferentially adjacent a first side edge of each axially extending commissure support post.

11. The prosthetic heart valve of claim 10, wherein the respective reinforced column is a first reinforced column and wherein a second reinforced column is disposed circumferentially adjacent a second side edge of each axially extending commissure support post.

12. The prosthetic heart valve of any one of claims 1-11, further comprising a valvular structure disposed within and coupled to the annular frame.

13. The prosthetic heart valve of any one of claims 1-12, wherein each angled strut in a reinforced column is a reinforced strut.

14. The prosthetic heart valve of any one of claims 1-12, wherein each reinforced column comprises reinforced struts in the first row of angled struts and the second row of angled struts, and wherein the one or more intermediate rows of angled struts are nonreinforced struts.

15. The prosthetic heart valve of any one of claims 1-14, wherein the first row of struts form pairs of angled struts, wherein the struts of each part of angled struts are connected together at their adjacent ends by an outflow apex region, and wherein the outflow apex region has a narrowed thickness relative to each strut of the pair of angled struts.

16. A prosthetic heart valve, comprising: a radially expandable and compressible annular frame comprising: a plurality of interconnected angled struts defining a plurality of axially extending columns arranged circumferentially around the frame, the plurality of interconnected angled struts arranged to form a first row of angled struts at a first end of the frame, one or more intermediate rows of angled struts, and a second row of angled struts at a second end of the frame, and a plurality of axially extending struts that extend between the first row of angled struts at the first end of the frame and a first row of the one or more intermediate rows of angled struts; and a plurality of leaflets disposed within the frame and secured together at their adjacent sides to form commissures; wherein a set of the plurality of axially extending struts are commissure support posts; wherein the plurality of angled struts comprises a plurality of reinforced struts and a plurality of non-reinforced struts, and wherein each of the plurality of reinforced struts have a width greater than a width of each of the non-reinforced struts; wherein the axially extending columns comprise one or more reinforced columns comprising one or more of the plurality of reinforced struts; wherein the one or more reinforced columns are each disposed circumferentially adjacent a respective axially extending commissure support post; and wherein the commissures are secured to the commissure support posts of the frame.

17. The prosthetic heart valve of claim 16, wherein the plurality of axially extending columns comprises nine axially extending columns.

18. The prosthetic heart valve of claim 17, wherein there are three axially extending columns between one of the commissure support posts and another one of the commissure support posts, and wherein two of the three axially extending columns are reinforced columns.

19. The prosthetic heart valve of claim 16, wherein the plurality of axially extending columns comprises twelve columns.

20. The prosthetic heart valve of claim 19, wherein there are four axially extending columns between one of the commissure support posts and another one of the commissure support posts, and wherein two of the four axially extending columns are reinforced columns.

21. The prosthetic heart valve of any one of claims 16-20, wherein each angled strut in a reinforced column is a reinforced strut.

22. The prosthetic heart valve of any one of claims 16-20, wherein each reinforced column comprises reinforced struts in the first row of angled struts and the second row of angled struts, and wherein all of the angled struts in the one or more intermediate rows of angled struts are non-reinforced struts.

23. The prosthetic heart valve of any of claims 16-22, wherein the plurality of axially extending columns comprises a plurality of reinforced columns and a plurality of nonreinforced columns, wherein there is at least one non-reinforced column between two reinforced columns.

24. The prosthetic heart valve of claim 23, wherein all of the angled struts of the non-reinforced columns are non-reinforced struts.

25. The prosthetic heart valve of any of claims 23 or 24, wherein each reinforced column has the same configuration of reinforced struts and non-reinforced struts.

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