artificial heart valves

Abstract

An expandable frame for a prosthetic heart valve is disclosed. As an example, the prosthetic valve can include a frame including interconnected angled struts defining rows of cells between first and second ends of the frame, the struts including a first row of struts at the first end, a second row of struts, and a third row of struts. The first row of first cells is disposed at the first end and is defined by the first row of struts and the second row of struts, the second row of second cells is disposed adjacent to the first row of first cells and is defined by the second row of struts and the third row of struts, each first cell being wider than each second cell, and the second row of struts including a plurality of free vertex regions, each connecting adjacent ends of a respective pair of angled struts and having a first surface with a constant convex curvature.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 401,538, filed August 26, 2022, which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to an expandable prosthetic heart valve, including a frame for the prosthetic heart valve. [Background technology]

[0003] The human heart can suffer from a variety of valvular diseases. These valvular diseases can lead to serious cardiac dysfunction, ultimately necessitating repair of the native valve or replacement of the native valve with a prosthetic valve. There are several known repair devices (e.g., stents) and prosthetic valves, as well as several known methods for 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 within the body that are not easily accessible by surgery and to locations where non-surgical access is desirable. In one specific example, a prosthetic heart valve can be crimped onto the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) to reach the implantation site within the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon to which the prosthetic valve is attached, or by activating a mechanical actuator that applies an expansive force to the prosthetic valve, or by deploying the prosthetic valve from a sheath on a delivery device, allowing the prosthetic valve to self-expand to its functional size.

[0004] Most expandable prosthetic heart valves include a radially expandable and compressible cylindrical metal frame or stent, and prosthetic valve leaflets attached to the inside of the frame. In some embodiments, the prosthetic heart valve can include an inner skirt disposed around the inside of the frame, with the leaflets secured to the inner skirt.

[0005] In some embodiments, the prosthetic heart valve may be implanted within the aortic root, which includes the left and right coronary ostia and is defined between the native aortic annulus and the sino-ascending junction (STJ). The prosthetic heart valve may be implanted either within the native aortic valve or within a previously implanted prosthetic heart valve (e.g., previously implanted via a valve-in-valve (ViV) procedure). However, during such implantation, there may be a risk of at least partially blocking the coronary ostia due to the leaflets of the aortic valve being pushed laterally during expansion of the prosthetic heart valve, the leaflets of the previously implanted prosthetic heart valve being similarly pushed laterally during expansion of the new prosthetic heart valve during the ViV procedure, and / or the overlapping frames of the two valves after the ViV procedure. As a result, access to the coronary arteries for subsequent interventions (e.g., via a catheter) may become more difficult.

[0006] Therefore, there is a need for improved frame designs for prosthetic heart valves. Summary of the Invention

[0007] Prosthetic heart valves, delivery devices, and methods for implanting the prosthetic heart valves are described herein. In particular, examples of radially expandable and compressible frames for prosthetic heart valves are described herein. The frame of the prosthetic heart valve can include a plurality of interconnected struts defining a plurality of cell rows disposed between the outflow end and the inflow end of the frame. In some embodiments, a first cell row disposed at the outflow end can have fewer cells than subsequent rows of the frame, such that the cells of the first cell row have a larger width (circumferentially) than the cells of the subsequent rows. As a result, cells of a second cell row adjacent to the first cell row can have apexes that are exposed (or free) and not attached to the additional struts defining the first cell row. In some embodiments, these apexes, like the apexes or apex regions of the first cell row at the outflow end of the frame, can have a curved profile with a constant convex curvature between the angled struts or strut portions to which they are connected. As a result, these apexes or apex regions may be more atraumatic and may not interfere with the leaflets of the prosthetic heart valve as they open and close during operation of the prosthetic heart valve. In some embodiments, an inner skirt may be disposed about the inner surface of the frame, with the outflow edge of the inner skirt secured to the struts forming the first and second rows of cells and positioned below (upstream of, or toward the inflow end of, the frame) the exposed apexes or apex regions. Thus, the devices and methods disclosed herein may overcome, among other things, one or more deficiencies of typical prosthetic heart valves.

[0008] The prosthetic heart valve may include a frame and a valvular structure coupled to the frame. In addition to these components, the prosthetic heart valve may further include one or more of the components disclosed herein.

[0009] In some embodiments, the frame can include a plurality of interconnected angled struts defining a plurality of circumferentially extending cell rows disposed between the outflow end and the inflow end of the frame, the plurality of interconnected angled struts arranged to form a plurality of circumferentially extending strut rows, including a first strut row at the outflow end of the frame, a second strut row upstream of the first strut row, and a third strut row upstream of the second strut row.

[0010] In some embodiments, the plurality of circumferentially extending cell rows includes a first row of first cells disposed at the outflow end and defined at least in part by a first row of struts and a second row of struts, and a second row of second cells disposed upstream of the first row of first cells and defined at least in part by a second row of struts and a third row of struts, wherein each first cell of the first row of first cells has a first width that is greater than a second width of each second cell of the second row of second cells.

[0011] In some embodiments, the second row of struts includes a plurality of free vertex regions, each free vertex region connecting together adjacent ends of a respective pair of angled struts of the second row of struts.

[0012] In some embodiments, each free vertex region has a first surface facing in a downstream direction and an opposing second surface facing in an upstream direction, the first surface having a constant convex curvature extending between adjacent ends of a respective pair of angled struts.

[0013] In some embodiments, the plurality of interconnected struts further includes a plurality of axially extending struts circumferentially spaced about the frame and connected to the first row of struts, a first portion of the angled struts of the second row of struts each directly connected to a respective axially extending strut of the plurality of axially extending struts, and a second portion of the angled struts of the second row of struts forming pairs of angled struts connected together by free vertex regions not attached to the plurality of axially extending struts.

[0014] In some embodiments, the prosthetic heart valve may include an inner skirt disposed around the inner surface of the frame, the outflow edge portion of the inner skirt being secured to the second row of struts, and at each free apex region, the outflow edge portion being disposed upstream of the free apex region.

[0015] In some embodiments, a prosthetic heart valve comprises a radially expandable and compressible annular frame including a plurality of interconnected angled struts defining a plurality of circumferentially extending cell rows disposed between an outflow end and an inflow end of the frame, the plurality of interconnected angled struts being arranged to form a plurality of circumferentially extending strut rows, including a first strut row at the outflow end of the frame, a second strut row upstream of the first strut row, and a third strut row upstream of the second strut row, the plurality of circumferentially extending cell rows including a first row of first cells disposed at the outflow end and defined at least in part by the first and second strut row, and a second row of second cells disposed upstream of the first row of first cells and defined at least in part by the second and third strut row, each first cell of the first row of first cells having a first width greater than a second width of each second cell of the second row of second cells. The second row of struts includes a plurality of free vertex regions, each free vertex region connecting adjacent ends of each pair of angled struts of the second row of struts together and having a first surface facing in a downstream direction and an opposing second surface facing in an upstream direction, the first surface having a constant convex curvature extending between adjacent ends of each pair of angled struts.

[0016] In some embodiments, the prosthetic heart valve comprises a radially expandable and foldable annular frame including a plurality of interconnected struts defining a plurality of circumferentially extending cell rows disposed between the outflow end and the inflow end of the frame. The plurality of interconnected struts includes a plurality of circumferentially extending angled strut rows including a first row of struts at the outflow end of the frame, a second row of struts upstream of the first row of struts, a third row of struts upstream of the second row of struts, and a plurality of axial struts spaced circumferentially around the frame and extending between the first and second rows of struts. The plurality of circumferentially extending cell rows includes a first row of first cells disposed at the outflow end and defined at least in part by the first and second rows of struts and the plurality of axial struts, and a second row of second cells disposed upstream of the first row of first cells and defined at least in part by the second and third rows of struts. Each first cell in the first row of first cells has a first width greater than a second width of each second cell in the second row of second cells. The second row of second cells includes a first portion of the second cell defined by a first pair of angled struts in the second row of struts directly connected at adjacent ends thereof to the plurality of axial struts, and a second portion of the second cell defined by a second pair of angled struts in the second row of struts and a plurality of free vertex regions. Each free vertex region connects adjacent ends of a respective second pair of angled struts together and has a first surface facing a downstream direction and an opposing second surface facing an upstream direction, the first surface having a constant convex curvature extending between adjacent ends of the respective second pair of angled struts, and the plurality of free vertex regions are not attached to the plurality of axial struts.

[0017] In some embodiments, the prosthetic heart valve comprises a radially expandable and collapsible annular frame including a plurality of interconnected struts defining a plurality of circumferentially extending cell rows disposed between the outflow end and the inflow end of the frame. The plurality of interconnected struts includes a circumferentially extending row of first struts defining the outflow end, each first strut including two angled strut sections interconnected by an outflow apex region, the outflow apex region curved between the two angled strut sections and having a width that is narrower than the width of the two angled strut sections. The plurality of interconnected struts further includes a plurality of axially extending struts spaced circumferentially around the frame and connected to the first row of struts, and a circumferentially extending row of angled second struts disposed upstream of the first row of struts. Each first portion of the second struts in the angled second row of struts is directly connected to a respective axially extending strut of the plurality of axially extending struts. A second portion of the second struts of the angled second row of struts form pairs of second struts connected together by free vertex regions not attached to the plurality of axially extending struts, the free vertex regions of each respective pair of second struts having a first surface facing a downstream direction and an opposing second surface facing an upstream direction, the first surface curved between each pair of second struts, and the second surface concave inwardly toward the first surface such that the width of the free vertex region between the first surface and the second surface is smaller than the width of each pair of second struts. The plurality of interconnected struts further includes a third circumferentially extending angled row of struts, wherein the first row of struts, the axially extending struts, and the second angled row of struts form a first row of cells of the plurality of rows of cells disposed at the outflow end, and the second angled row of struts and the third angled row of struts form a second row of cells of the plurality of rows of cells disposed adjacent to the first row of cells, wherein the first width of each cell of the first row of cells is wider than the second width of each cell of the second row of cells. The prosthetic heart valve further comprises a plurality of leaflets fixed inside the frame and configured to open and close to regulate blood flow through the prosthetic heart valve from the inflow end to the outflow end of the frame, and wherein each free apex region of the second angled row of struts is positioned at the level of a portion of the plurality of leaflets that open and close during operation of the prosthetic heart valve.

[0018] In some embodiments, a prosthetic heart valve comprises a radially expandable and compressible annular frame including a plurality of interconnected angled struts defining a plurality of circumferentially extending cell rows disposed between a first end and a second end of the frame, the plurality of interconnected angled struts being arranged to form a plurality of circumferentially extending strut rows, including a first strut row at the first end of the frame, a second strut row disposed adjacent to the first strut row, and a third strut row disposed adjacent to the second strut row, the second strut row being disposed between the first strut row and the third strut row. The plurality of circumferentially extending cell rows include a first row of first cells disposed at the first end and defined at least in part by the first row of struts and the second row of struts, and a second row of second cells disposed adjacent to the first row of first cells and defined at least in part by the second row of struts and the third row of struts, each first cell of the first row of first cells having a first width greater than a second width of each second cell of the second row of second cells. The second row of struts includes a plurality of free vertex regions, each free vertex region connecting adjacent ends of a respective pair of angled struts of the second row of struts together and having a first surface facing the first end of the frame and an opposing second surface facing the second end of the frame, the first surface having a constant convex curvature extending between the adjacent ends of the respective pair of angled struts.

[0019] In some embodiments, a prosthetic heart valve comprises a radially expandable and compressible annular frame including a plurality of interconnected struts defining a plurality of circumferentially extending cell rows disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts including a circumferentially extending row of outflow struts defining an outflow end, each outflow strut including two angled strut sections interconnected by an apex region, each outflow apex region curved between a corresponding pair of the two angled strut sections and having a narrowed width and a length extending along at least 25% of the total length of the outflow strut, the narrowed width being less than the width of the two angled strut sections. The plurality of interconnected struts further includes a circumferentially extending, angled first row of struts positioned upstream of the outflow strut row, the outflow strut row and the angled first row of struts at least partially forming a first row of cells among the plurality of circumferentially extending cell rows positioned at the outflow end, each cell of the first row of cells having a first width greater than second widths of cells of the remaining row of cells of the plurality of circumferentially extending cell rows.

[0020] In some embodiments, a prosthetic heart valve comprises a radially expandable and compressible annular frame including a plurality of interconnected angled struts defining a plurality of circumferentially extending cell rows disposed between a first end and a second end of the frame, the plurality of interconnected angled struts being arranged to form a plurality of circumferentially extending strut rows, including a first strut row at the first end of the frame, a second strut row disposed adjacent to the first strut row, and a third strut row disposed adjacent to the second strut row, the second strut row being disposed between the first strut row and the third strut row. The plurality of circumferentially extending cell rows include a first row of first cells disposed at the first end and defined at least in part by the first row of struts and the second row of struts, and a second row of second cells disposed adjacent to the first row of first cells and defined at least in part by the second row of struts and the third row of struts, each first cell of the first row of first cells having a first width greater than a second width of each second cell of the second row of second cells. The second row of struts includes a plurality of free vertices, each free vertex connecting adjacent ends of a respective pair of angled struts in the second row of struts. The prosthetic heart valve further includes an inner skirt disposed around an inner surface of the frame, a first edge portion of the inner skirt secured to the second row of struts, and at each free vertex, the first edge portion is disposed away from the free vertex toward the second end of the frame, and the second edge portion of the inner skirt is disposed at the second end of the frame.

[0021] In some embodiments, the prosthetic heart valve comprises a radially expandable and compressible annular frame including a plurality of interconnected angled struts arranged to form a plurality of circumferentially extending strut rows, including a first row of struts, a second row of struts downstream of the first row of struts, and a third row of struts downstream of the second row of struts. The prosthetic heart valve further comprises an inner skirt disposed around an inner surface of the frame. The inner skirt includes an inflow edge and an outflow edge, the outflow edge being sewn to the struts of the second row of struts and including a plurality of circumferentially spaced peaks, the peaks align with respective apexes of the second row of struts, and at least one peak has a straight edge spaced from the respective apex toward the inflow end of the frame.

[0022] In some embodiments, a prosthetic heart valve comprises a radially expandable and compressible annular frame including a plurality of interconnected angled struts defining a plurality of circumferentially extending cell rows disposed between an outflow end and an inflow end of the frame, the plurality of interconnected angled struts being arranged to form a plurality of circumferentially extending strut rows, including a first strut row at the outflow end of the frame, a second strut row upstream of the first strut row, and a third strut row upstream of the second strut row. The plurality of circumferentially extending cell rows include a first row of first cells disposed at the outflow end and defined at least in part by the first and second strut rows and axially extending struts interconnecting struts of the first and second strut rows, and a second row of second cells disposed upstream of the first row of first cells and defined at least in part by the second and third strut rows. The second row of struts includes a plurality of free vertex regions that are not connected to the struts of the first row of struts by axially extending struts, each free vertex region connecting adjacent ends of a respective pair of angled struts of the second row of struts together and having a first surface facing in a downstream direction, an opposing second surface facing in an upstream direction, and a width measured from the first surface to the second surface, the width being less than the width of the struts connected by the free vertex region.

[0023] In some embodiments, the prosthetic heart valve includes one or more components described in Examples 1-38, Examples 55-124, and Example 126 below.

[0024] The assembly may include a delivery device and an implantable prosthetic heart valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration.

[0025] In some embodiments, the delivery device comprises a balloon, and the folded prosthetic heart valve is mounted around the balloon and can be radially expanded to an expanded configuration while the balloon is within the patient.

[0026] In some embodiments, the prosthetic heart valve comprises a radially expandable and compressible annular frame including a plurality of interconnected angled struts defining a plurality of circumferentially extending rows of cells disposed between the outflow end and the inflow end of the frame.

[0027] In some embodiments, the plurality of interconnected angled struts are arranged to form a plurality of circumferentially extending strut rows, including a first strut row at the outflow end of the frame, a second strut row upstream of the first strut row, and a third strut row upstream of the second strut row. The plurality of circumferentially extending cell rows include a first row of first cells disposed at the outflow end and defined at least in part by the first and second strut row rows, and a second row of second cells disposed upstream of the first row of first cells and defined at least in part by the second and third strut row rows, each first cell of the first row of first cells having a first width greater than a second width of each second cell of the second row of second cells.

[0028] In some embodiments, the second row of struts includes a plurality of free vertex regions, each free vertex region connecting together a respective pair of angled struts of the second row of struts.

[0029] In some embodiments, each vertex region has a first surface facing the outflow end of the frame and an opposing second surface facing the inflow end of the frame.

[0030] In some embodiments, the first surface forms a single continuous convex curve from one angled post of each pair of angled posts on a first side of the free vertex region to the other angled post of each pair of angled posts on an opposite second side of the free vertex region.

[0031] In some embodiments, the prosthetic heart valve may include an inner skirt disposed around the inner surface of the frame, the outflow edge portion of the inner skirt being secured to the second row of struts, and at each free apex region, the outflow edge portion being disposed upstream of the free apex region.

[0032] In some embodiments, the assembly comprises a delivery device including a balloon and an implantable prosthetic heart valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. The prosthetic heart valve comprises a radially expandable and compressible annular frame including a plurality of interconnected angled struts defining a plurality of circumferentially extending cell rows disposed between an outflow end and an inflow end of the frame, the plurality of interconnected angled struts being arranged to form a plurality of circumferentially extending strut rows, including a first strut row at the outflow end of the frame, a second strut row upstream of the first strut row, and a third strut row upstream of the second strut row. The plurality of circumferentially extending cell rows include a first row of first cells disposed at the outflow end and defined at least in part by a first row of struts and a second row of struts, and a second row of second cells disposed upstream of the first row of first cells and defined at least in part by a second row of struts and a third row of struts, each first cell of the first row of first cells having a first width greater than a second width of each second cell of the second row of second cells. The second row of struts includes a plurality of free vertex regions, each connecting a respective pair of angled struts of the second row of struts together and having a first surface facing the outflow end of the frame and an opposing second surface facing the inflow end of the frame. The first surface forms a single continuous convex curve from one angled strut of each pair of angled struts on a first side of the free vertex region to another angled strut of each pair of angled struts on a second side opposite the free vertex region. The collapsed prosthetic heart valve is mounted around the balloon and can be radially expanded to an expanded configuration while the balloon is within the patient.

[0033] In some embodiments, the assembly includes one or more of the components listed in Examples 39-54 below.

[0034] The various innovations in 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. These and other objects, features, and advantages of the present disclosure will become more apparent from the following Detailed Description, from the claims, and from the accompanying drawings. [Brief explanation of the drawings]

[0035] [Figure 1] FIG. 1 is a side view of a prosthetic heart valve, according to one embodiment. [Figure 2] FIG. 2 is a side view of the frame of the prosthetic heart valve of FIG. 1. [Figure 3] 3 is a side view of a portion of the frame of FIG. 2, showing the portion of the frame in a straight (non-annular) state. [Figure 4] 1A-1C are exemplary side views of a delivery device configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site. [Figure 5A] FIG. 1 is a side view of a portion of an exemplary frame of a prosthetic heart valve in a radially expanded configuration, the frame including a first row of cells that is wider than an adjacent second row of cells, such that a portion of the second row of cells has a curved apex region that is not attached to the struts that form the first row of cells. [Figure 5B] FIG. 5B is a side view of the portion of the frame of FIG. 5A in a radially compressed configuration. [Figure 6] FIG. 5B is a side view of the entire frame of FIG. 5A in a straight (non-circular) state. [Figure 7] 10 is a side view of a portion of another exemplary frame for a prosthetic heart valve, in which the angled struts of the frame assume an inwardly bent orientation in the frame's radially compressed state. FIG. [Figure 8]FIG. 10 is a side view of a portion of another exemplary frame for a prosthetic heart valve, in which the angled struts of the frame assume a relatively straight, vertical orientation in the frame's radially compressed state. [Figure 9] FIG. 5B is an interior side view of the portion of the frame of FIG. 5A having an inner skirt disposed on the inner surface of the strut, the inner skirt having an outflow edge disposed below the apex region not attached to the strut forming the first row of cells. [Figure 10] 10 is a cross-sectional view of the frame and inner skirt of FIG. 9, with the outer skirt positioned on the outer surface of the frame and the outflow edge of the inner skirt folded over itself and disposed upstream of the free apex region of the frame. DETAILED DESCRIPTION OF THE INVENTION

[0036] General Considerations For purposes of this specification, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, apparatus, and systems should not be construed as limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone, in various combinations with each other, and in various subcombinations with each other. The methods, apparatus, and systems are not limited to any particular aspect, feature, or combination thereof, and the disclosed examples do not require that any one or more particular advantages be present or problems be solved.

[0037] Although some operations in the disclosed embodiments are described in a particular sequential order for convenience of presentation, it will be understood that aspects of the description encompass permutations unless a particular order is required by specific language set forth below. For example, operations described sequentially may, in some cases, be permuted or performed simultaneously. Moreover, for purposes of simplicity, the accompanying drawings may not show various ways in which the disclosed methods can be used in combination with other methods. Additionally, the description sometimes uses terms such as "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 those skilled in the art.

[0038] 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." Furthermore, the term "coupled" generally means to be physically, mechanically, chemically, magnetically, and / or electrically coupled or connected, and does not exclude the presence of intervening elements between coupled or associated members, unless specific language to the contrary exists.

[0039] As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and farther away from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is farther away from the user and closer to the implantation site. Thus, for example, proximal movement of a device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of a device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal" and "axial," unless expressly defined otherwise, refer to axes extending in a proximal-distal direction.

[0040] As used herein, "eg" means "for example" and "ie" means "that is."

[0041] Overview of the disclosed technology As described above, the prosthetic heart valve includes a radially expandable and compressible annular frame and a plurality of valve leaflets attached to the frame. The frame can include a plurality of cell rows formed by interconnected struts of the frame. The plurality of cell rows can include a first cell row disposed at the outflow end of the frame. In some embodiments, the cells of the first cell row are axially elongated relative to the cells of the remaining cell rows of the frame.

[0042] Additionally or alternatively, in some embodiments, to further increase the size of the cells in the first cell row for increased coronary access after implantation, the cells in the first cell row can be wider circumferentially than the cells in the remaining rows of cells in the frame. For example, in some cases, there can be one cell in the first cell row for every two cells in each remaining cell row (e.g., because the cells in the first row are twice as wide as the cells in the remaining cell rows). As a result, cells in the second cell row that are disposed adjacent to and connected to the first cell row can include free vertices that are not attached to the (additional) struts that define the first cell row.

[0043] As the leaflets of the prosthetic valve (when implanted in a patient's body) move between closed and open states during operation of the prosthetic valve, they (in their open state) may come into contact with these free apexes of the second row of cells, which in some cases may shorten the lifespan of the valve leaflets.

[0044] The prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be compressed or held by an implant delivery device in a radially compressed state and advanced through a patient's vascular system on the delivery device. After the prosthetic valve reaches the implantation site, the prosthetic valve can be expanded to a radially expanded state. It will be understood that the prosthetic valves disclosed herein can be used with a variety of implant delivery devices and implanted via a variety of delivery procedures, examples of which will be described in more detail below.

[0045] In some cases, when the prosthetic valve is in a radially compressed state and the angled struts of the frame assume a more vertical orientation, the leaflets may become trapped between adjacent struts of the frame, which may also reduce the lifespan of the leaflets.

[0046] Described herein are various examples of frames for prosthetic heart valves that include a first row of cells disposed at a first end (e.g., the outflow end) of the frame that is circumferentially wider than the cells of the remaining rows of cells of the frame, thereby resulting in exposed or free apexes formed by a row of angled struts that partially define a second row of cells adjacent to the first row of cells. The free apexes can have a first surface facing the outflow end of the frame and an opposing second surface facing the inflow end of the frame, the first surface having a constant convex curvature extending between adjacent ends of a pair of angled struts in the row of angled struts. In some embodiments, the free apexes or apex regions can have a narrower width than the angled struts to which they are connected. As a result, these free apexes or apex regions can be more atraumatic and may not interfere with the leaflets of the prosthetic heart valve as they open and close during operation of the prosthetic heart valve. As a result, the lifespan of the valve leaflets can be extended.

[0047] In some embodiments, an inner skirt may be disposed around the inner surface of the frame. The outflow edge of the inner skirt may have a zigzag shape and be secured to the row of struts that form the free apex. However, in some embodiments, the outflow edge of the inner skirt may be trimmed or disposed below or upstream of the free apex. In some embodiments, the outflow edge may also be folded back on itself (toward the frame) so that its rough edge is pushed away from the leaflets. As a result, the lifespan of the leaflets may be extended.

[0048] FIG. 1 illustrates an exemplary prosthetic device (e.g., a prosthetic heart valve) including a frame, leaflets secured inside the frame, and an outer skirt disposed around the outer surface of the frame. In some embodiments, the frame may include a plurality of interconnected angled struts at the inflow and outflow ends of the frame, and apex regions extending and / or curved between the angled struts, as shown in FIGS. 2 and 3. In some embodiments, the cells of a first cell row of the frame located at a first end (e.g., the outflow end) of the frame may be axially elongated relative to the cells of the remaining cell rows of the frame (FIGS. 2 and 3). The prosthetic device can be advanced through the patient's vasculature to the native heart valve by a delivery device, such as the exemplary delivery device shown in FIG. 4.

[0049] In some embodiments, as shown in Figures 5A-6, the cells of the first cell row may also be wider in the circumferential direction than the cells of the remaining cell rows of the frame. In some cases, each cell of the first cell row may span the width of two cells of the second cell row adjacent to the first cell row, thereby providing a free apex region at a first end of a portion of the cells of the second cell row (Figures 5A and 6). The free apex region may have a downstream-facing surface with a constant convex curvature extending between the angled struts or strut segments to which they are connected (Figures 5A-6). In some embodiments, the free apex region may have a shape similar to the apex region at the outflow end and / or inflow end of the frame (e.g., as shown in Figures 1-3 and 5A-6).

[0050] FIG. 5A shows a portion of the frame in a radially expanded state, and FIG. 5B shows a portion of the frame in a radially compressed (or folded) state. In the radially compressed state, the angled struts of the frame may assume a more vertical orientation (extending axially) and be positioned closer to one another. The frame may further include relatively short horizontal struts extending between adjacent cells of the same cell row that act as spacers and are sized to maintain a minimal gap between adjacent struts in the radially compressed (crimped) state, thereby reducing the risk of pinching the valve leaflets (FIGS. 5A and 5B). The frame may be configured so that the angled struts assume a relatively straight vertical orientation (FIG. 8) or an inwardly bent shape (FIG. 7) in the compressed state. When bent inward, the length of the horizontal struts may be selected to maintain a minimal gap between the struts (e.g., at their narrowest point).

[0051] 9 and 10 show an inner skirt disposed on the inner surface of the frame with its outflow edge disposed upstream of the free apex region.

[0052] Examples of the disclosed technology FIG. 1 illustrates a prosthetic heart valve 100 (artificial valve) according to one embodiment. While all of the prosthetic valves disclosed herein are configured to be implanted into the native aortic valve annulus, in other embodiments, they can also be configured to be implanted into other native valve annuluses of the heart (such as the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves can also be implanted within blood vessels communicating with the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), the superior vena cava, or the inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels of a patient. The disclosed prosthetic valves can also 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.

[0053] In some embodiments, the disclosed prosthetic valves can be implanted within a docking or anchoring device implanted within a native heart valve or blood vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed, for example, in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at a native mitral valve, as disclosed, for example, in PCT Publication No. WO 2020 / 247907, 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 to replace the function of a diseased tricuspid valve, as disclosed, for example, in U.S. Patent Application Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0054] The prosthetic heart valve 100 may include a stent or frame 102, a valvular structure 104, and a circumferential outer sealing member or outer skirt 106. The prosthetic heart valve 100 (and frame 102) may have an inflow end 108 and an outflow end 110. The valvular structure 104 may be disposed within the frame 102, with the outer skirt 106 disposed around the outer surface of the frame 102.

[0055] The valve structure 104 may include a plurality of leaflets 112 (e.g., three leaflets as shown in FIG. 1 ) collectively forming a valve structure that may be arranged to collapse in a tricuspid configuration. The leaflets 112 may be secured to one another at adjacent sides (e.g., commissure tabs) to form commissures 114 of the valve structure 104. For example, each leaflet 112 may include an opposing commissure tab disposed on an opposite side of each leaflet 112 and a leaflet edge portion extending between the opposing commissure tabs. The leaflet edge portions of the leaflets 112 may have an undulating, curved, scalloped shape and may be secured directly to the frame 102 (e.g., with sutures). However, in alternative embodiments, the leaflet edge portions of the leaflets 112 may be secured to an inner skirt, which in turn may be secured to the frame 102. In some embodiments, the leaflets 112 may be formed from pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or a variety of other suitable natural or synthetic materials known in the art and described in U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0056] In some embodiments, the outer skirt 106 can be an annular skirt. In some cases, the outer skirt 106 can include one or more skirt sections connected together and / or individually to the frame 102. The outer skirt 106 can include a woven or polymeric material, such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, and the like. In some cases, instead of having a relatively straight upper edge portion as shown in FIG. 1 , the outer skirt 106 can have a contoured 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, that can be used with the frame 102 can be found in U.S. Provisional Patent Application No. 63 / 366,599, filed June 17, 2022, which is incorporated herein by reference.

[0057] Frame 102 may 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). Frame 102 is shown alone in FIG. 2, and a portion of frame 102 in a linear (non-annular) configuration is shown in FIG. 3.

[0058] The frame 102 can be formed from any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol). If constructed from a plastically expandable material, the frame 102 (and thus the valve 100) can be crimped into a radially compressed state on a delivery catheter and then expanded within the patient's body by an inflatable balloon or equivalent expansion mechanism. If constructed from a self-expandable material, the frame 102 (and thus the valve 100) can be crimped into a radially compressed state and constrained in the compressed state by insertion into a sheath or equivalent mechanism on the delivery catheter. After introduction into the body, the valve can be advanced from the delivery sheath, allowing the valve to expand to its functional size.

[0059] Suitable plastically expandable materials that can be used to form the frames (e.g., frame 102) disclosed herein include metal alloys, polymers, or combinations thereof. Exemplary metal alloys can include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some embodiments, frame 102 can include stainless steel. In some embodiments, frame 102 can include cobalt-chromium. In some embodiments, frame 102 can include nickel-cobalt-chromium. In some embodiments, frame 102 can include a nickel-cobalt-chromium-molybdenum alloy, such as MP35N® (a trademark of SPS technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 includes 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight.

[0060] 2 and 3, the frame 102 can include a plurality of interconnected struts 116 that form rows of open cells 118 between the outflow end 110 and the inflow end 108 of the frame 102. In some embodiments, as shown in FIGS. 2 and 3, the frame 102 is comprised of three rows of cells 118, with the cells 120 of a first row (the upper row in the orientation shown in FIGS. 2 and 3) disposed at the outflow end 110. The first row of cells 120 includes cells 118 that are elongated in the axial direction (relative to a central longitudinal axis 122 of the frame 102) compared to the cells 118 of the remaining rows of cells. For example, the cells 118 of the first cell row 120 may have a longer axial length 124 (FIG. 3) than the cells 118 of the remaining rows, which include a second cell row 126 and a third cell row 128, with the third cell row 128 disposed at the inlet end 108 and the second cell row 126 disposed between the first cell row 120 and the third cell row 128.

[0061] In some embodiments, as shown in Figure 2, each column of cells includes nine cells 118. Thus, in such embodiments, frame 102 may be referred to as a nine-cell frame.

[0062] In alternative embodiments, frame 102 may include more than three rows of cells (e.g., four or five rows) and / or may include more than ten cells or fewer than eight cells per row. In some embodiments, cells 118 in first row of cells 120 may not be elongated compared to cells 118 in the remaining rows of cells of frame 102 (second row of cells 126 and third row of cells 128).

[0063] The interconnected struts 116 may include a plurality of angled struts 130, 132, 134, and 136 arranged in multiple rows of circumferentially extending angled strut rows, which rows are arranged along the length of the frame 102 between the outflow end 110 and the inflow end 108. For example, the frame 102 may include a first circumferentially extending row of angled struts 130 arranged end-to-end at the inflow end 108 of the frame, a second circumferentially extending row of angled struts 132, a third circumferentially extending row of angled struts 134, and a fourth circumferentially extending row of angled struts 136 at the outflow end 110 of the frame 102. The fourth row of angled struts 136 may be connected to the third row of angled struts 134 by a plurality of axially extending window struts (or window strut portions) 138 and a plurality of axial (or axially extending) struts 140. Axially extending window struts 138 (also referred to as axial struts including commissural windows) are spaced circumferentially around the frame 102 and define commissural windows (e.g., open windows) 142 adapted to receive a pair of commissural tabs of a pair of adjacent leaflets 112 disposed at a commissure (e.g., commissure 114 shown in FIG. 1 ). In some examples, the commissural windows 142 and / or the axially extending window struts 138 defining the commissural windows 142 may be referred to herein as commissural features or commissural supports, where each commissural feature or support is configured to receive and / or be secured to a pair of commissural tabs of a pair of adjacent leaflets.

[0064] One or more (e.g., two as shown in FIGS. 2 and 3 ) axial struts 140 can be positioned circumferentially between two commissural windows 142 formed by the window struts 138. Because the frame 102 can include fewer cells per row (e.g., nine) and fewer axial struts 140 between each commissural window 142 compared to conventional prosthetic heart valves, each cell 118 can have an increased width (circumferentially), thereby providing a larger opening for blood flow and / or coronary access.

[0065] Each axial strut 140 and each window strut 138 extends from a location defined by the convergence of the lower ends (e.g., the ends disposed inwardly from and furthest away from the outflow end 110) of two angled struts 136 (which may also be referred to as upper strut junctions or upper elongated strut junctions) to another location defined by the convergence of the upper ends (e.g., the ends disposed closer to the outflow end 110) of two angled struts 134 (which may also be referred to as lower strut junctions or lower elongated strut junctions). Each axial strut 140 and each window strut 138 forms the axial sides of two adjacent cells in the first cell row 120.

[0066] In some embodiments, as shown in FIG. 3, each axial strut 140 can have a width 144 (FIG. 3) that is greater than the width of the angular struts 130, 132, 134, and 136. As used herein, the "width" of a strut is measured between opposite locations on opposite faces of the strut that extend between the radially opposed inner and outer surfaces of the strut (relative to the central longitudinal axis 122 of the frame 102). The "thickness" of a strut is measured between opposite locations on the radially opposed inner and outer surfaces of the strut and is perpendicular to the width of the strut. In some embodiments, the width 144 of the axial strut 140 is greater (e.g., twice as greater) than the width of the angular struts of the frame 102 by 50% to 200%, 75% to 150%, or at least 100%.

[0067] By providing axial struts 140 with widths 144 that are greater than the widths of the other angled struts of frame 102, a larger contact area is provided when leaflets 112 contact the wider axial struts 140 during systole, thereby distributing stress and reducing the extent to which leaflets 112 may collapse radially outward through cells 118 onto axial struts 140. As a result, the long-term durability of leaflets 112 can be increased.

[0068] Because the cells 118 of the frame 102 can have a relatively large width compared to alternative prosthetic valves having more than nine cells per row (as introduced above), wider axial struts 140 can be more easily incorporated into the frame 102 without sacrificing open space for blood flow and / or coronary access.

[0069] The commissure tabs 115 of adjacent leaflets 112 can be secured together to form a commissure 114 (FIG. 1). Each commissure 114 of the prosthetic heart valve 100 includes two paired commissure tabs 115, one from each of two adjacent leaflets 112, that extend through commissure windows 142 in the frame 102. Each commissure 114 can be secured to a window strut 138 that forms the commissure window 142.

[0070] The leaflet edge portion (e.g., scalloped edge) of each leaflet 112 can be secured to the frame 102 via one or more fasteners (e.g., sutures). In some embodiments, the leaflet edge portion of each leaflet 112 can be secured directly to struts (e.g., angled struts 130, 132, and 134) of the frame 102. For example, the leaflet edge portion of the leaflet 112 can be sutured to the angled struts 130, 132, and 134 that generally follow the contour of the leaflet edge portion of the leaflet 112.

[0071] In some embodiments, the leaflet edge portions of the leaflets 112 may be secured to the inner skirt, which may be secured directly to the frame 102 .

[0072] Various methods for securing the leaflets 112 to a frame such as frame 102 are disclosed in U.S. Provisional Patent Application No. 63 / 278,922, filed November 12, 2021, and U.S. Provisional Patent Application No. 63 / 300,302, filed January 18, 2022, both of which are incorporated herein by reference.

[0073] 2 and 3 , in some embodiments, one or more or each of the axial struts 140 may include an inflow end portion 146 (e.g., an end portion closest to the inflow end 108) and an outflow end portion 148 that are wider relative to an intermediate portion 150 (which may be defined by a width 144) of the axial strut 140. In some cases, the inflow end portion 146 of the axial strut 140 may include an opening 147. The opening 147 may be configured to receive a fastener (e.g., suture) for attaching the soft component of the prosthetic heart valve 100 to the frame 102. For example, in some cases, the outer skirt 106 may be positioned around the outer surface of the frame 102, and an upper or outflow edge portion of the outer skirt 106 may be secured to the opening 147 by a fastener 149 (e.g., suture), as shown in FIG.

[0074] The interconnected columns 116 may also include horizontal columns 182 extending between adjacent cells 118 of a row of cells of the frame 102 (FIGS. 2 and 3). The horizontal columns 182 may extend circumferentially and may also be referred to as circumferentially extending columns 182. The horizontal columns 182 may connect the angled columns of two adjacent rows of the frame 102. For example, each horizontal column 182 may connect to two angled columns of one row (e.g., column 134 shown in FIG. 3) and to two angled columns of another adjacent row (e.g., column 132 shown in FIG. 3). As a result, the angled struts 184 extending between the axially extending window struts 138 and the horizontal struts 182, and the angled struts 186 extending between the horizontal struts 182 and another horizontal strut 182 disposed adjacent the inflow end 108 of the frame 102, can be aligned along an angled line that can follow the scallop line of the valve leaflet (when the leaflet is attached to the frame 102). Thus, when the frame 102 is in a radially expanded configuration (as shown in FIGS. 2 and 3 ), the horizontal struts 182 allow the angled struts to conform to a shape that more closely matches the shape of the scallop line of the valve leaflet. Additionally, the horizontal struts 182 can function as spacers that can maintain a specified gap between the angled struts when the frame 102 is in a radially compressed configuration, thereby reducing the risk of the leaflet becoming pinched between the struts in the radially compressed configuration.

[0075] The frame 102 may further include a plurality of apex regions 152 formed at the inflow end 108 and the outflow end 110, with each apex region 152 extending between and forming a junction between two of the angled struts 130 at the inflow end 108 or two of the angled struts 136 at the outflow end 110. As such, the apex regions 152 are circumferentially spaced apart from one another at the inflow end 108 and the outflow end 110.

[0076] Each apex region 152 may include an apex 154 (the axially highest or most outwardly extending point) and two thinned (or narrowed) strut portions 156, one extending from either side of the apex 154 to a corresponding wider angled strut 136 (outflow end 110) or angled strut 130 (inflow end 108) ( FIG. 3 ). In this manner, each apex region 152 at the outflow end 110 may form a narrowed transition region between and to the two angled struts 136 extending from the corresponding apex region 152, and each apex region 152 at the inflow end 108 may form a narrowed transition region between and to the two angled struts 130 extending from the corresponding apex region 152.

[0077] The thinned strut portion 156 of the apex region 152 may have a width 158 that is smaller than the width 160 of the angled struts 130 or 136 (FIG. 3). In some embodiments, the width 158 may be a uniform width (e.g., along the entire length of the strut portion 156). In some embodiments, the width 158 of the thinned strut portion 156 may be smaller than the width 160 of the angled struts 130 and / or 136 by approximately 0.06 mm to 0.15 mm.

[0078] The thin-walled strut portions 156 of the apex region 152 can have a first length 162 (FIG. 3). In some embodiments, the first length 162 is in the range of 0.8 mm to 1.4 mm, 0.9 mm to 1.2 mm, 0.95 mm to 1.05 mm, or about 1.0 mm (e.g., ±0.03 mm). In alternative embodiments, the first length 162 is in the range of 0.3 mm to 0.7 mm, 0.4 mm to 0.6 mm, 0.45 mm to 0.55 mm, or about 0.5 mm (e.g., ±0.03 mm).

[0079] Thus, each outflow apex region 152 may include two thin-walled strut portions 156 having a first length 162, with each strut portion 156 extending outward from the apex 154 relative to a central longitudinal axis 164 of the cell 118. Thus, the total length of the apex region 152 may be twice the first length 162.

[0080] Two corresponding angled struts 136 in each apex region 152 and outflow end 110 may form outflow struts 166 , and two corresponding angled struts 130 in each apex region 152 and inflow end 108 may form inflow struts 168 .

[0081] Each outflow strut 166 and inflow strut 168 can have a length that includes the apex region 152 and the two angled struts 136 or 130 (or strut portions) on either side of the apex region 152. In FIG. 3 , half of the total length of the outflow strut 166 and inflow strut 168 is shown as length 170, which extends from the end of one angled strut 136 or 130 to the central longitudinal axis 164. Thus, the length of each outflow strut 166 and each inflow strut 168 is twice the length 170. In some embodiments, the half length 170 of each inflow strut 168 can be different from the half length 170 of each outflow strut 166.

[0082] In some cases, 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. Stated another way, the length of each apex region 152 (whose total length is twice the first length 162) can be at least 25% of the total length (twice the length 170) of the outflow strut 166 or inflow strut 168. In some embodiments, the length of each apex region 152 can be more than 25%, e.g., 25% to 35%, of the total length of the corresponding outflow strut 166 or inflow strut 168.

[0083] In some embodiments, each apex region 152 may include a curved, axially-facing outer surface 172 and an arcuate or curved, axially-facing inner recess 174 that forms the thin-walled strut portion 156. For example, the curved inner recess 174 may be recessed from the inner surface of the angled strut portion 156 toward the curved outer surface 172, thereby forming a thinner-walled strut portion 156 with a smaller width. Thus, the curved inner recess 174 may be formed on the cell side of the apex region 152 (e.g., as opposed to the outside of the apex region 152).

[0084] In some embodiments, 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 (e.g., the curved outer surface 172 can have a constant convex curvature).

[0085] As used herein, "constant convex curvature" can refer to a continuously curved surface that is convex and has no points of inflection (no change in direction of curvature).

[0086] Each apex region 152 may have a radius of curvature 176 along its curved outer surface 172 (e.g., in some cases, along the entire or full length of the curved outer surface 172) (FIG. 3). In some cases, the radius of curvature 176 at the apex 154 and / or along the entire curved outer surface 172 of the apex region 152 may be greater than 1 mm. In some cases, the radius of curvature 176 may range from 1 mm to 20 mm, 3 mm to 16 mm, or 8 mm to 14 mm. In some cases, the radius of curvature 176 may be greater than 10 mm. The radius of curvature 176 may depend on (and thus vary due to) the width 158 (e.g., the amount of width reduction from the angled struts 130 or 136) and the first length 162 of the thin-walled strut portion 156.

[0087] Furthermore, the height (axial height) 178 of the apex region 152, which can be defined in the axial direction from the outer surfaces of the two angled struts 130 or 136 to the curved outer surface 172 of the apex region 152 at the apex 414, can be the width 158 of the thin-walled strut portions 156 ( FIG. 3 ). In this manner, the height 178 of the apex region 152 can be relatively small and add little height to the overall axial height of the radially expanded frame 102. Thus, the leaflets 112 ( FIG. 1 ) secured to the frame 102 can be disposed occluded relative to the inflow end 108, thereby leaving a larger open space at the outflow end 110 of the frame 102 that is not blocked by the leaflets 112.

[0088] In some embodiments, each vertex region 152 can form an angle 180 between two angled struts 130 or 136 extending from either side of the corresponding vertex region 152 (FIG. 3). In some cases, angle 180 can range from (but not limited to) 120 degrees to 140 degrees (e.g., angle 180 is greater than 120 degrees and less than or equal to 140 degrees).

[0089] Further details and examples of prosthetic heart valve frames, including apex regions, can be found in PCT Application No. PCT / US2022 / 025687, which is incorporated herein by reference.

[0090] 4 illustrates an example delivery device 200 that may be used to implant an expandable prosthetic heart valve (e.g., the prosthetic heart valve 100 of FIG. 1 and / or any other prosthetic heart valve described herein). In some embodiments, the delivery device 200 is specifically configured for use in introducing the prosthetic valve into the heart.

[0091] 4 is a balloon catheter including a handle 202 and a steerable outer shaft 204 extending distally from the handle 202. The delivery device 200 may further include an intermediate shaft 206 (which may also be referred to as a balloon shaft) extending proximally and distally from the handle 202, the portion extending distally from the handle 202 also extending coaxially through the outer shaft 204. In addition, the delivery device 200 may further include an inner shaft 208 extending coaxially distally from the handle 202 through the intermediate shaft 206 and the outer shaft 204, and coaxially proximally from the handle 202 through the intermediate shaft 206.

[0092] The outer shaft 204 and the intermediate shaft 206 can be configured to translate (e.g., move) longitudinally relative to one another along a central longitudinal axis 220 of the delivery device 200 to facilitate delivery and positioning of the prosthetic valve at an implantation site within a patient's body.

[0093] The midshaft 206 may include a proximal end portion 210 that extends proximally from the proximal end portion of the handle 202 to an adapter 212. A rotatable knob 214 may be attached to the proximal end portion 210 and configured to rotate the midshaft 206 relative to the outer shaft 204 about a central longitudinal axis 220.

[0094] The adapter 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 connected to the inner lumen of the midshaft 206.

[0095] The midshaft 206 can further include a distal end portion that extends distally beyond the distal end of the outer shaft 204 when the distal end of the outer shaft 204 is positioned away from the inflatable balloon 218 of the delivery device 200. The distal end portion of the inner shaft 208 can extend distally beyond the distal end portion of the midshaft 206.

[0096] The balloon 218 can be coupled to the distal end portion of the midshaft 206 .

[0097] In some embodiments, the distal end of the balloon 218 can be coupled to the distal end of the delivery device 200, such as a nosecone 222 (as shown in FIG. 4 ), or to an alternative component at the distal end (e.g., distal shoulder) of the delivery device 200. An intermediate portion of the balloon 218 can cover a valve mounting portion 224 at the distal end of the delivery device 200, and the distal end portion of the balloon 218 can cover a distal shoulder 226 of the delivery device 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 device 200.

[0098] The balloon shoulder assembly, including the distal shoulder 226, is configured to maintain the prosthetic heart valve 250 (or other medical device) in a fixed position on the balloon 218 during delivery through the patient's vasculature.

[0099] The outer shaft 204 can include a distal tip portion 228 mounted on its distal end. The outer shaft 204 and the midshaft 206 can be axially translated relative to one another to position the distal tip portion 228 adjacent the proximal end of the valve mounting portion 224 when the prosthetic valve 250 is mounted in a 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. In this manner, the distal tip portion 228 can be configured to resist axial, proximal movement of the prosthetic valve 250 relative to the balloon 218 when the distal tip portion 228 is positioned adjacent the proximal side of the valve mounting portion 224.

[0100] An annular space can be defined between the outer surface of the inner shaft 208 and the inner surface of the midshaft 206, and the annular space can be configured to receive fluid from a fluid source via the second port 240 of the adapter 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 the inner surface of the balloon 218. In this manner, fluid from the fluid source can flow from the annular space into the fluid passageway, thereby inflating the balloon 218 and radially expanding and deploying the prosthetic valve 250.

[0101] The inner lumen of the inner shaft can be configured to receive a guidewire therethrough for navigating the distal end portion of the delivery device 200 to the target implantation site.

[0102] The handle 202 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 200. In the illustrated example, for example, the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, that is operably coupled to a proximal end portion of a pull wire. The pull wire can extend distally from the handle 202 through the outer shaft 204 and have a distal end portion secured to the outer shaft 204 at or near its distal end. By rotating the knob 260, the tension in the pull wire can be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 200. Further details regarding steering or bending mechanisms in delivery devices can be found in U.S. Pat. No. 9,339,384, which is incorporated herein by reference.

[0103] The handle 202 can further include an adjustment mechanism 261 that includes an adjustment member, such as the illustrated rotatable knob 262, and an associated locking mechanism that includes 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 regarding the delivery device 200 can be found in PCT Application No. PCT / US2021 / 047056, which is incorporated herein by reference.

[0104] 5A-6 illustrate another exemplary frame 300 for a prosthetic heart valve. In some embodiments, frame 300 may be used in place of frame 102 in prosthetic heart valve 100 of FIG. 1. Frame 300 may be radially compressible and expandable between a radially compressed (or collapsed) configuration ( FIG. 5B ) and a radially expanded configuration ( FIG. 5A ). A portion of frame 300 is shown in FIGS. 5A and 5B , while the entire frame 300 is shown in a linear (non-annular) configuration in FIG. 8 . Note that frame 300 may have an annular configuration, such as that shown in FIG. 2 .

[0105] Frame 300 may comprise any of the plastically expandable materials (eg, stainless steel, etc.) or self-expanding materials (eg, nickel titanium alloys (NiTi), such as nitinol) described above with respect to frame 102.

[0106] The frame 300 can include a plurality of interconnected struts 316 forming multiple rows of open cells 314, 318 between the outflow end 302 and the inflow end 304 of the frame 300. In some embodiments, as shown in FIGS. 5A-6 , the frame 300 can include four rows of cells 314, 318, with a first (upper, as viewed in FIGS. 5A-6 ) row of cells 320 disposed at the outflow end 302. The first row of cells 320 includes cells 314 that are axially elongated (relative to the central longitudinal axis of the frame 300 and extending between the outflow end 302 and the inflow end 304) and circumferentially wider than the cells 318 in the remaining rows. For example, the cells 314 in the first row of cells 320 can have a longer axial length 324 (as measured from the outflow end to the inflow end of the cells 320, FIG. 5A ) and a larger width 322 than the cells 318 in the remaining rows. The increased width 322 and axial length 324 of the first row of cells 314 may provide a larger opening for coronary access through the frame 300 .

[0107] The remaining cell rows can include a second cell row 326, a third cell row 328, and a fourth cell row 329. The fourth cell row 329 is disposed at the inlet end 304, and the second cell row 326 is disposed between the first cell row 320 and the third cell row 328 (which is disposed adjacent to the fourth cell row 329).

[0108] In some embodiments, as shown in FIG. 6 , second cell column 326, third cell column 328, and fourth cell column 329 each include 12 cells 318, and first cell column 320 includes six cells 314. This arrangement of different numbers of cells between first cell column 320 and the remaining cell columns results from the width 322 of the cells 314 in first cell column 320 being twice the width 312 of the cells 318 in the remaining cell columns (e.g., adjacent second cell column 326). Thus, in some embodiments, each cell 314 in first cell column 320 may span the width of two cells 314 (such as third cell column 328, as shown in FIGS. 5A and 6 ). In other words, the width 322 of each cell 314 may be twice the width 312 of the cell 318.

[0109] In alternative embodiments, frame 300 may include a different number of cell rows, such as three (e.g., similar to frame 102 in FIGS. 2 and 3 ) or five. Additionally or alternatively, in some cases, frame 300 may include more or fewer than 12 and 6 cells per row (e.g., 10 and 5 cells per row). In some alternative embodiments, cells 314 in first cell row 320 may not be elongated compared to cells 318 in the remaining cell rows of frame 300. In yet other alternative embodiments, width 322 of cells 314 may be larger or smaller than shown in FIGS. 5A and 6 (e.g., 1.5 times wider than width 312 of cells 318).

[0110] The interconnected struts 316 may include a plurality of angled struts 330, 331, 332, 334, and 336 arranged in multiple rows of circumferentially extending angled strut rows, which rows are arranged along the length of the frame 300 between the outflow end 302 and the inflow end 304. For example, the frame 300 may include a first circumferentially extending row of angled struts 330 arranged end-to-end at the inflow end 304 of the frame, a second circumferentially extending row of angled struts 331, a third circumferentially extending row of angled struts 332, a fourth circumferentially extending row of angled struts 334, and a fifth circumferentially extending row of angled struts 336 at the outflow end 302 of the frame 300. Circumferentially extending angled strut rows (as well as additional components such as cell rows) may be referred to herein as being "upstream" or "downstream" of other circumferentially extending angled strut rows. As used herein, "upstream" or "downstream" is relative to the frame's outflow end 302 (which is the frame's downstream end) and the frame's inflow end 304 (which is the frame's upstream end), and the direction of blood flow through frame 300 (from inflow end 304 to outflow end 302). For example, fourth angled strut row 334 is positioned upstream of fifth angled strut row 336.

[0111] Fifth row of angled struts 336 may be connected to fourth row of angled struts 334 by a plurality of axially extending window struts 338 (which may be configured similarly to window struts 138 of frame 102, as described above) and a plurality of axial (or axially extending) struts 340 (which may be configured similarly to axial struts 140 of frame 102, as described above). Axially extending window struts 338 (also referred to as axial struts including commissural windows) are spaced apart circumferentially around frame 300 and define commissural windows (e.g., open windows) 342 adapted to receive a pair of commissure tabs of a pair of adjacent leaflets disposed at a commissure (e.g., commissure 114 shown in FIG. 1 ). In some examples, the commissural windows 342 and / or the axially extending window struts 338 defining the commissural windows 342 may be referred to herein as commissural features or commissural supports, with each commissural feature or support configured to receive and / or be secured to a pair of commissural tabs of a pair of adjacent leaflets.

[0112] 6 , one axial strut 340 can be positioned circumferentially between two commissure windows 342 formed by the window struts 338. Each axial strut 340 and each window strut 338 extends from a location defined by the convergence of the lower ends (e.g., the ends positioned inwardly and furthest from the outflow end 302) of two angled struts 336 (which may also be referred to as upper strut junctions or upper elongated strut junctions) to another location defined by the convergence of the upper ends (e.g., the ends positioned closer to the outflow end 302) of two angled struts 334 (which may also be referred to as lower strut junctions or lower elongated strut junctions). Each axial strut 340 and each window strut 338 forms the axial sides of two adjacent cells in the first cell row 320.

[0113] In some embodiments, width 360 of angled strut 336 may be greater than the widths of the struts in the remaining strut rows (e.g., to provide increased strength to larger / wider cells 314). For example, width 360 may be greater than width 362 of angled strut 334 (which, in some embodiments, may be the width of angled struts 331 and 332). Additionally, in some embodiments, width 364 of angled strut 330 may be greater than width 362. However, in some embodiments, width 360 of angled strut 336 may still be greater than width 364 of angled strut 330.

[0114] In some embodiments, frame 300 may further comprise a plurality of apex regions 352 formed at outflow end 302 and a plurality of apex regions 354 formed at inflow end 304. Each apex region 354 may extend between, and form a junction with, two angled struts 330 at inflow end 304 of frame 300. The apex regions 354 may be configured the same as or similar to apex regions 152, as described above (and thus will not be described again here for brevity).

[0115] Each apex region 352 can extend between, and form a junction between, two angled struts 336 at the outflow end 302 of the frame 300. The apex regions 352 can also be configured similarly to the apex regions 152, as described above. For example, each apex region 352 can include an apex 355 and two thinned (or narrowed) strut portions 356 ( FIG. 5A ) that extend from either side of the apex 355 to corresponding wider angled struts 336 (at the outflow end 302). The thinned strut portions 356 of the apex region 352 can have a width 357 that is less than the width 360 of the angled struts 336 ( FIG. 5A ).

[0116] In some embodiments, width 357 can be approximately 0.06 mm to 0.15 mm less than width 360 of angled strut 336. For example, in some instances, width 360 can be approximately 0.46 mm and width 357 can be approximately 0.4 mm.

[0117] However, because cell 314 is wider relative to the cells in the remaining rows of frame 300 (and relative to cells 118 of frame 102), angled struts 336 have a longer length than angled struts 330. Thus, the length of thin-walled strut portions 356 in each vertex region 352 may be longer than, for example, thin-walled strut portions 358 in each vertex region 354 (FIG. 5A). However, the relative proportions between thin-walled strut portions 356 in vertex region 352 and angled struts 336 may be similar or the same as those described above for vertex region 152 of frame 102 (e.g., the length of thin-walled strut portions 356 may be at least 25% of the length of angled struts 336).

[0118] Each apex region 352 and two corresponding angled struts 336 in the outflow end 302 can form an outflow strut 366, and each apex region 354 and two corresponding angled struts 330 in the inflow end 304 can form an inflow strut 368. Due to the increased width 322 of the cells 314 in the first cell row 320, the outflow struts 366 are longer than the inflow struts 368.

[0119] The length of apex region 352 (e.g., the arc length along the two thin-walled strut portions 356, similar to length 162 shown in FIG. 3) is at least 25% of the length of outflow struts 366. Similarly, the length of apex region 354 is at least 25% of the length of inflow struts 368.

[0120] The overall shape or curvature of vertex regions 352 and 354 may be similar to the shape or curvature of vertex region 152, as described above. Exemplary dimensions of vertex regions 352 and 354 are described below with reference to free vertex region 370.

[0121] In this manner, the apex region 352 can have a relatively small axial height and (similar to that described above for the apex region 152, despite the longer length of the outflow struts 366) not add much height to the overall axial height of the radially expanded frame 300. In this manner, the axial height of the radially expanded frame 300 can be less than alternative valve frames having apexes that are more pointed and / or have a greater axial height.

[0122] Because of the increased width 322 of cells 314 in first cell row 320 compared to width 312 of cells 318 in second cell row 326, a portion of second cell row 320 may be formed by struts having exposed or free apex regions 370 that are not attached to additional struts in an adjacent cell row (first cell row 320). As used herein, "free apex regions" may refer to apex regions that are curved and not attached (directly attached) to any other struts except for the angled struts extending therebetween (such as a pair of angled struts 334 and the corresponding apex regions 370 disposed therebetween).

[0123] For example, the free apex region 370 is not attached to any axial struts 340 or axially-extending window struts 338. As shown in Figures 5A-6, every other cell 318 in the second row of cells 326 may be defined by a strut having a free apex region 370. In an alternative embodiment, two or more cells 318 defined by a strut having a free apex region 370 may be disposed between cells 318 that are directly connected to an axial strut (e.g., an axial strut 340 or an axially-extending window strut 338) in an adjacent row of struts.

[0124] As mentioned above, in some embodiments, the free apex region 370 may interact with the leaflets of a prosthetic heart valve. For example, when a leaflet (such as leaflet 112 of FIG. 1 ) is secured to the frame 300 as described herein, the free apex region 370 may be positioned at the level (or axial height) of the portion of the leaflet that opens and closes during operation of the prosthetic heart valve. Thus, in some cases, when implanted in a patient, the leaflet may contact the free apex region 370 when the leaflet is in an open state.

[0125] Thus, it is beneficial for the free vertex region 370 to have a curved outer surface 372, similar to the vertex regions 352 and 354. For example, as shown in Figures 5A-6, each free vertex region 370 can have an overall shape similar to the vertex regions 352 and 354, as described above, such as having a continuously curved outer surface 372 with a constant convex curvature curving between the angled struts 334 to which it is connected (e.g., having a radius of curvature in any of the ranges described herein for any of the curved vertex regions). The outer surface 372 can face downstream, or toward the outflow end 302.

[0126] As used herein, "constant convex curvature" can refer to a continuously curved surface that is convex and has no points of inflection (no change in direction of curvature).

[0127] Each free vertex region 370 can extend to form a junction between two angled struts 334 and can include an apex and two thinned (or narrowed) strut portions extending from either side of the apex to a corresponding wider angled strut 334 (similar to vertex regions 352, 354 and / or 152). The overall shape or curvature of free vertex region 370 can be similar to the shape or curvature of vertex region 152, as described above.

[0128] The free vertex regions 370 (e.g., the thin-walled strut portions and apexes of the free vertex regions 370) have narrowed widths relative to the angled struts 334 to which they are connected, thereby forming an internal recess 374 on the cell side of each free vertex region 370 (e.g., the internal recess 374 is formed on the opposing internal surface 373 of the free vertex region 370 facing upstream, or toward the inflow end 304). The width of the free vertex region 370 can be defined between the external surface 372 and the internal surface 373.

[0129] The width of the free vertex region 370 may be approximately 0.06 mm to 0.15 mm less than the width of the angled struts 334. For example, in some cases, the width of the free vertex region 370 may be approximately 0.18 mm and the width of the angled struts 334 may be approximately 0.24 mm.

[0130] The length of each free vertex region 370 (e.g., the arc length along the vertex region 370, similar to length 162 shown in FIG. 3) is at least 25% of the length of the entire strut to which it belongs, including the free vertex region 370 and the two angled struts 335 to which it is connected, if the strut is defined.

[0131] In some cases, the length of the free apex region 370, the outflow apex region 352, and / or the inflow apex region 354 may range from 0.5 mm to 4.7 mm or from 0.9 mm to 3.7 mm (e.g., the free apex region 370 is at the lower end of the range and the outflow apex region 352 is at the upper end of the range).

[0132] In some embodiments, the radius of curvature of the free apex region 370, the outflow apex region 352, and / or the inflow apex region 354 may range from 0.3 mm to 10 mm, from 0.5 mm to 8 mm, or from 0.2 mm to 20 mm.

[0133] In some cases, the ratio of the width of any of the vertex regions 370, 352, and 354 to the width of the angled struts to which they connect (e.g., the ratio of the width of the free vertex region 370 to the width of the angled strut 334, and / or the ratio of the width 357 of the vertex region 352 to the width 360) may be in the range of 0.15 to 0.98, 0.4 to 0.8, or 0.6 to 0.9.

[0134] In some embodiments, the central longitudinal axis of each free vertex region 370 may be aligned (overlapping) with the central longitudinal axis of the corresponding vertex region 352. In alternative embodiments, the free vertex regions 370 may not be aligned with the corresponding vertex region 352 (e.g., if the cells 314 are not twice as wide as the cells 318 in the second cell row 326).

[0135] In this way, the free apex region 370 may have a more curved (less angular) outer surface that is more atraumatic and may not interfere with the leaflets of the prosthetic heart valve as they open and close during operation of the prosthetic heart valve, thus increasing the long-term durability of the prosthetic valve leaflets.

[0136] In alternative embodiments, the free vertex region 370 of the frame 300 may not include a curved outer surface 372 having a constant convex curvature. Instead, the free vertex region 370 may have an alternative shape similar to the axial strut 340 or the junction between two angled struts 334 that connect to the axially extending window strut 338.

[0137] 5A-6, the interconnected struts 316 of frame 300 may also include horizontal struts 382 (which may be similar to horizontal struts 182 of frame 102, as described above) that extend between adjacent cells 318 of a row of cells of frame 300. Horizontal struts 382 may connect the angled struts of two adjacent rows of angled struts of frame 300. As described above with reference to horizontal struts 182 of frame 102, horizontal struts 382 allow angled struts 330, 331, 332, and 334 to conform to a shape that more closely matches the shape of the scalloped lines of the prosthetic valve leaflets when frame 300 is in a radially expanded configuration (FIG. 5A). Additionally, the horizontal struts 382 can function as spacers that maintain a specified gap 384 between the angled struts 330, 331, 332, and 334 when the frame 300 is in a radially compressed configuration (FIG. 5B), and the specified gap 384 (to minimize the crimping profile of the prosthetic valve) can be minimized as much as possible while still being large enough to reduce the risk of trapping or pinching the leaflets of the prosthetic valve between adjacent angled struts 330, 331, 332, and 334 when the frame 300 is radially compressed (or crimped).

[0138] 7 and 8 illustrate two examples of prosthetic valve frames 400 and 500, respectively, that include horizontal struts 382 and angled struts 330, 331, 332, and 334 that assume either a relatively straight, vertical orientation (FIG. 8) or an inwardly bent orientation (FIG. 7) when the frame is radially compressed (or crimped). Frames 400 and 500 of FIGS. 7 and 8, respectively, may be similar to frame 300, but without the wider outflow cell (cell 314). However, it should be noted that either the angled or straight orientation of angled struts 330, 331, 332, and 334 may also be applied to frame 300, as described below with reference to FIGS. 7 and 8.

[0139] When the angled struts 330, 331, 332, and 334 assume their inwardly bent (or angled) orientation in the compressed state of the frame 400 ( FIG. 7 ), the length 404 of the horizontal struts 382 may be specified to maintain a minimum gap 402 between the angled struts, measured, for example, as the smallest width (circumferentially around the frame 400) between adjacent horizontal struts 382. The minimum gap 402 may reduce the crimp profile of the frame 400 while avoiding pinching the valve leaflets between the angled struts in the crimped state.

[0140] When the angled struts 330, 331, 332, and 334 assume a relatively straight (axial) vertical orientation in the compressed state of the frame 500 ( FIG. 8 ), the lengths 504 of the horizontal struts 382 can be specified to maintain a minimum gap 502 between the angled struts. The minimum gap 502 can reduce the crimped profile of the frame 500 while avoiding pinching the leaflets between the angled struts in the crimped state.

[0141] In some embodiments, the horizontal struts 382 are sized to maintain a minimum gap 402 or 502 within a range of about 0.2 mm to 0.7 mm or about 0.3 mm to 0.4 mm.

[0142] In other examples, the minimum gap 402 or 502 in the crimped configuration may be a function of the thickness of the prosthetic valve leaflets, and may be primarily due to the compressibility of the tissue of the leaflets. For example, for a leaflet having a thickness of approximately 0.2 mm, the minimum gap 402 or 502 may be designed to accommodate the leaflet folded upon itself, which may require a gap of at least 0.4 mm. However, if the tissue has a compressibility of approximately 50%, designing a minimum gap of approximately 0.2 mm may be sufficient.

[0143] In this way, the frame of the prosthetic heart valve can be configured to increase the durability and long-term life of the prosthetic heart valve (e.g., when implanted) while reducing the crimp profile of the prosthetic heart valve and reducing stress on the frame struts (e.g., due to the shape of the apex regions).

[0144] As mentioned above, in some embodiments, the prosthetic valve may include an inner skirt disposed on an inner surface of a frame (such as any one of the frames described herein or a similar frame). In some embodiments, the cusp portions of the valve leaflets (such as leaflets 112) may be secured to the inner skirt, which may then be secured directly to the frame.

[0145] 9 and 10 show an exemplary inner skirt 600 disposed on the inner surface of frame 300. For example, FIG. 9 shows an internal view of frame 300 with inner skirt 600 disposed against the inner surfaces of angled struts 330, 331, 332, 334, while FIG. 10 shows a cross-sectional view of frame 300 and inner skirt 600 of FIG. 9 with outer skirt 620 disposed around the outer surface of frame 300. It should be noted that although inner skirt 600 is illustrated on frame 300, inner skirt 600 may similarly be disposed on different prosthetic valve frames having free apexes or apex regions.

[0146] The inner skirt 600 may have an inflow edge portion 602 disposed at the inflow end 304 of the frame 300, and an outflow edge portion 604. The outflow edge portion 604 may have a zigzag shape. For example, as shown in FIG. 9 , the outflow edge portion 604 may include a plurality of circumferentially spaced peaks. The outflow edge portion 604 may also include a plurality of circumferentially spaced valleys, with one valley disposed between two adjacent peaks. In some embodiments, the shape of the outflow edge portion 604 may follow the shape of the fourth angled row of struts 334 (or the second row of struts relative to the outflow end 302). The outflow edge portion 604 may be secured to the angled struts 334 with, for example, a plurality of stitches 606.

[0147] At each free apex region 370 (or free apex of another frame), a respective apex of the outflow edge portion 604 of the inner skirt 600 may be aligned with the free apex region 370. At least one peak may be disposed below or upstream of each apex region 370, thereby exposing the free apex region 370 (as shown in FIGS. 9 and 10 ). For example, the outflow edge portion 604 does not cover the entire inner surface of the free apex region 370, and as a result, the apex region 370 protrudes above (or downstream of) the outflow edge portion 604.

[0148] In some embodiments, the peak of the outflow edge portion 604 may include a trimmed, flat, or straight edge 610 at each apex region 370. The straight edge 610 of the inner skirt 600 may be located upstream of and spaced apart from the respective apex region 370. In other words, the straight edge 610 may be spaced away from the respective apex region 370 toward the inflow end of the frame.

[0149] In some embodiments, the outflow edge portion 604 (or a portion thereof) is folded over upon itself, outward toward the frame 300 ( FIG. 10 ). As a result, the outflow edge 608 of the outflow edge portion 604 is disposed (sandwiched) between the inner surface of the frame 300 and an adjacent portion of the inner skirt 600 (as shown in FIG. 10 ). Thus, in some embodiments, one or more peaks of the outflow edge portion 604 can be folded over to form creases that form respective linear edges 610.

[0150] In some embodiments, the peaks of the outflow edge portion 604 include a plurality of first peaks that align with respective apexes of the angled struts 334 that connect to the axially extending window struts 338, and a plurality of second peaks that align with respective free apex regions 370. As described above, the second peaks can have straight edges 610, while the first peaks can be pointed (e.g., without trimming or folding). Thus, in some embodiments, the first peaks can extend axially toward the outflow end of the frame to a greater extent than the second peaks.

[0151] In some embodiments, the outflow edge 608 is fused or rougher than the remainder of the inner skirt 600. Thus, folding the outflow edge portion 604 in this manner can hide the outflow edge 608 from the interior of the prosthetic valve, thereby preventing the leaflets from contacting the outflow edge 608.

[0152] When frame 300 (or another frame to which inner skirt 600 is attached) is radially compressed (or crimped) into a radially compressed configuration, outflow edge portion 604 of inner skirt 600 slides upstream of frame 300, further away from free apex region 370. During radial expansion of the frame (e.g., to a radially expanded configuration), outflow edge portion 604 is pulled up by stitches 606 sliding over angled struts 334, but not up to apex region 370.

[0153] This ensures that the flat or straight edge 610 of the inner skirt 600 remains below (upstream) the level of the free apex region 370, thereby reducing the likelihood that the outflow edge 608 will contact the tissue of the leaflet. Additionally, by including the inner skirt 600 on a frame 300 that includes a curved apex region 370 (as described above), leaflet longevity can be further increased.

[0154] Inner skirt 600 may be formed entirely or partially from any suitable biological material, synthetic material (e.g., any of a variety of polymers), or combinations thereof. In some examples, inner skirt 600 may include a fabric having interwoven yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric may have a plush nap or pile. Exemplary fabrics having a plush nap or pile include velour, velvet, bettin, corduroy, terry cloth, fleece, and the like. In some examples, inner skirt 600 may include a fabric without interwoven or randomly interwoven yarns or fibers, such as a felt or an electrospun fabric. Exemplary materials that may be used to form such fabrics (with or without interwoven yarns or fibers) include, but are not limited to, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide, and the like. In some embodiments, inner skirt 600 can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (e.g., thermoplastic polyurethane (TPU)), etc. In some embodiments, inner skirt 600 can comprise a sponge material or foam, such as polyurethane foam. In some embodiments, inner skirt 600 can comprise natural tissue, such as pericardial tissue (e.g., bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0155] delivery technology To implant a prosthetic valve into a 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 device. The prosthetic valve and the distal end portion of the delivery device are inserted into the femoral artery and 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, by actuating one or more actuators of the delivery device, or by deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted within the native aortic valve via a transapical procedure, in which the prosthetic valve (on the distal end portion of the delivery device) 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, the prosthetic valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as by a partial J sternotomy or a right parasternal minithoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0156] To implant 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 device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and 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, the prosthetic valve can be implanted within the native mitral valve via a transapical procedure, in which the prosthetic valve (on the distal end portion of the delivery device) 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.

[0157] To implant 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 device. The prosthetic valve and distal end portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used to implant a prosthetic valve within the native pulmonary valve or pulmonary artery, except the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0158] Another delivery approach is the transatrial approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and an incision is made through the atrial wall (of the right or left atrium) to access either of the native heart valves. Atrial delivery can also be performed intravascularly, such as from a pulmonary vein. Yet another delivery approach is the transventricular approach, in which the prosthetic valve (on the distal end portion of the delivery device) is inserted through an incision in the chest and an incision is made through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve into the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0159] In all delivery approaches, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any of the prosthetic valves disclosed herein can be implanted using any of a variety of delivery procedures and any of a variety of delivery devices known in the art.

[0160] Any system, device, apparatus, etc. described herein can be sterilized (e.g., using heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use on patients, and any method described herein can include sterilizing the associated system, device, apparatus, etc. as one of the method steps. Examples of heat sterilization include steam sterilization and autoclave sterilization. Examples of radiation used for sterilization include, but are not limited to, gamma rays, ultraviolet light, and electron beams. Examples of chemicals used for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Hydrogen peroxide sterilization can be performed, for example, using hydrogen peroxide plasma.

[0161] Additional Examples of the Disclosed Technology In view of the implementations described above with respect to the disclosed subject matter, the present application discloses the following additional examples: It should be noted that any single feature in an example individually, or two or more features in combination in that example, and optionally in combination with one or more features in one or more additional examples, are also further examples falling within the disclosure of the present application.

[0162] Example 1. A prosthetic heart valve comprising a radially expandable and compressible annular frame including a plurality of interconnected angled struts defining a plurality of circumferentially extending cell rows disposed between an outflow end and an inflow end of the frame, the plurality of interconnected angled struts being arranged to form a plurality of circumferentially extending strut rows, including a first strut row at the outflow end of the frame, a second strut row upstream of the first strut row, and a third strut row upstream of the second strut row, the plurality of circumferentially extending cell rows being disposed at the outflow end and including a first of the first cells defined at least in part by the first strut row and the second strut row. and a second row of second cells disposed upstream of the first row of first cells and defined at least in part by a second row of struts and a third row of struts, each first cell of the first row of first cells having a first width greater than a second width of each second cell of the second row of second cells, the second row of struts including a plurality of free vertex regions, each free vertex region connecting together adjacent ends of a respective pair of angled struts of the first row of struts, and having a first surface facing a downstream direction and an opposing second surface facing an upstream direction, the first surface having a constant convex curvature extending between adjacent ends of each pair of angled struts.

[0163] Example 2. The prosthetic heart valve of any example herein, particularly Example 1, wherein the second surface of each free apex region defines a concave region between adjacent ends of each pair of angled struts such that the width of the free apex region between the first surface and the second surface is less than the width of each pair of angled struts.

[0164] Example 3. A prosthetic heart valve as described in any example herein, particularly either Example 1 or Example 2, wherein the first surface of the free apex region forms a single continuous convex curve from the downstream-facing surface of the first angled strut of each pair of angled struts located on a first side of the free apex region to the downstream-facing surface of the second angled strut of each pair of angled struts located on an opposite second side of the free apex region.

[0165] Example 4. A prosthetic heart valve according to any example herein, particularly any one of Examples 1-3, wherein the first width is twice as wide as the second width.

[0166] Example 5. The prosthetic heart valve of any example herein, particularly any one of Examples 1-4, wherein the first row of first cells comprises 6 cells and the second row of second cells comprises 12 cells.

[0167] Example 6. The prosthetic heart valve of any example herein, particularly any one of Examples 1-5, wherein the frame further comprises a plurality of axially extending struts extending between the first and second rows of struts and defining the axial sides of the first row of first cells.

[0168] Example 7. The prosthetic heart valve of any example herein, particularly Example 6, wherein first portions of the struts in the second row of struts form pairs of angled struts that are each connected to a respective axially extending strut of the plurality of axially extending struts, and second portions of the struts in the second row of struts form pairs of angled struts that are connected by a respective free apex region of the plurality of apex regions, and the plurality of free apex regions are not attached to the plurality of axially extending struts.

[0169] Example 8. The prosthetic heart valve of any example herein, particularly any of Example 6 or Example 7, wherein a portion of the plurality of axially extending struts are axially extending window struts defining commissural windows, and further comprising a plurality of leaflets secured together at adjacent sides thereof to form commissures, the commissures being secured to the commissure windows of the frame.

[0170] Example 9. The prosthetic heart valve of any example herein, particularly any one of Examples 1-8, wherein the first row of struts forms pairs of angled struts, the struts of each pair of angled struts in the first row being connected together at their adjacent ends by an outflow apex region, the outflow apex region being curved between the pair of angled struts and having a narrowed width compared to the pair of angled struts.

[0171] Example 10. The prosthetic heart valve of any example herein, particularly Example 9, wherein the outflow apex region has a third surface and an opposing fourth surface facing an upstream direction, the third surface having a constant convex curvature extending between the pair of angled struts.

[0172] Example 11. The prosthetic heart valve of any example herein, particularly any one of Examples 1-10, wherein each first cell of the first row of first cells has a first axial length that is greater than the second axial length of each second cell of the second row of second cells.

[0173] Example 12. A prosthetic heart valve as described in any of the examples herein, particularly any one of Examples 1-11, wherein the frame further comprises a plurality of horizontal struts extending between adjacent second cells of the second row of second cells, each horizontal strut of the plurality of horizontal struts connecting two adjacent struts of the second row of struts to two adjacent struts of the third row of struts.

[0174] Example 13. The prosthetic heart valve of any example herein, particularly Example 12, wherein the circumferential length of each horizontal strut is specified to maintain a specified gap between two adjacent struts in the second row of struts and two adjacent struts in the third row of struts when the frame is in a radially compressed configuration.

[0175] Example 14. The prosthetic heart valve of any example herein, particularly Example 13, wherein in the radially compressed configuration, the second row of struts and the third row of struts are axially oriented in a relatively straight, perpendicular orientation relative to the central longitudinal axis of the frame.

[0176] Example 15. The prosthetic heart valve of any example herein, particularly Example 13, wherein in the radially compressed configuration, the second and third rows of struts extend axially but are angled inwardly toward each other with adjacent horizontal struts.

[0177] Example 16. The prosthetic heart valve of any example herein, particularly any one of Examples 1-15, wherein each strut in the first row of struts has a first width that is greater than the second width of each strut in the second row of struts.

[0178] Example 17. The prosthetic heart valve of any example herein, particularly Example 16, wherein the plurality of circumferentially extending rows of struts further includes a fourth row of struts at the inflow end of the frame, each strut of the fourth row of struts having a third width that is smaller than the first width and greater than the second width.

[0179] Example 18. A prosthetic heart valve as described in any of the examples herein, particularly any one of Examples 1 to 17, further comprising a plurality of leaflets fixed to the inside of the frame and configured to open and close to regulate the flow of blood through the prosthetic heart valve from the inflow end to the outflow end of the frame, wherein each free apex region of the second row of struts is positioned at the level of a portion of the plurality of leaflets that open and close during operation of the prosthetic heart valve.

[0180] Example 19. A prosthetic heart valve comprising: a radially expandable and foldable annular frame including a plurality of interconnected struts defining a plurality of circumferentially extending cell rows disposed between an outflow end and an inflow end of the frame, the plurality of interconnected struts including a plurality of circumferentially extending angled strut rows including a first strut row at the outflow end of the frame, a second strut row upstream of the first strut row, and a third strut row upstream of the second strut row; and a plurality of axial struts circumferentially spaced about the frame and extending between the first and second strut row; the plurality of circumferentially extending cell rows including a first row of first cells disposed at the outflow end and defined at least in part by the first and second strut row and the plurality of axial struts; and a first row of first cells disposed upstream of the first row of first cells and defined by the second and third strut row. and a second row of second cells at least partially defined by the first pair of angled struts of the second row of first cells, each first cell of the first row of first cells having a first width greater than a second width of each second cell of the second row of second cells, the second row of second cells including: a first portion of the second cells defined by a first pair of angled struts of the second row of struts that are directly connected at adjacent ends to a plurality of axial struts; and a second portion of the second cells defined by a second pair of angled struts of the second row of struts and a plurality of free apex regions, each free apex region connecting adjacent ends of a respective second pair of angled struts together and having a first surface facing a downstream direction and an opposing second surface facing an upstream direction, the first surface having a constant convex curvature extending between adjacent ends of a respective second pair of angled struts, and the plurality of free apex regions are not attached to the plurality of axial struts.

[0181] Example 20. The prosthetic heart valve of any example herein, particularly Example 19, wherein the second surface of each free apex region defines an internal recess recessed inwardly from the upstream-facing surface of each second pair of angled struts toward the first surface of the apex region, such that the width of the apex region between its first surface and second surface is less than the width of each second pair of angled struts.

[0182] Example 21. A prosthetic heart valve as described in any example herein, particularly either Example 19 or Example 20, wherein each strut of the first row of struts includes two angled strut portions interconnected by an outflow apex region, the outflow apex region having a constant convex curvature on its downstream-facing surface, curved between the two angled strut portions, and having a narrower width compared to the two angled strut portions.

[0183] Example 22 The prosthetic heart valve of any example herein, particularly example 21, wherein each outflow apex forms an angle between two angled strut portions that is greater than 120 degrees.

[0184] Example 23 The prosthetic heart valve of any example herein, particularly either Example 21 or Example 22, wherein each outflow apex region is aligned with and axially spaced apart from a corresponding free apex region.

[0185] Example 24. The prosthetic heart valve of any example herein, particularly any one of Examples 19-23, wherein the first width is twice as wide as the second width.

[0186] Example 25. A prosthetic heart valve described in any example herein, particularly any one of Examples 19-24, wherein each first cell of the first row of first cells has a first axial length that is longer than the second axial length of each second cell of the second row of second cells.

[0187] Example 26. A prosthetic heart valve as described in any of the examples herein, particularly any one of Examples 19 to 25, further comprising a plurality of valve leaflets fixed to the inside of the frame and configured to open and close to regulate the flow of blood through the prosthetic heart valve from the inflow end to the outflow end of the frame, wherein each free apex region of the second row of struts is positioned at the level of a portion of the plurality of valve leaflets that open and close during operation of the prosthetic heart valve.

[0188] Example 27. A prosthetic heart valve as described in any example herein, particularly example 26, wherein the frame is radially expandable and foldable between a radially expanded configuration and a radially compressed configuration, and the frame further includes a plurality of horizontal struts extending between adjacent second cells of the second row of second cells, each horizontal strut of the plurality of horizontal struts connecting two adjacent struts of the second row of struts to two adjacent struts of the third row of struts, and configured to maintain a specified gap between two adjacent struts of the second row of struts and two adjacent struts of the third row of struts when the frame is in the radially folded configuration.

[0189] Example 28. A prosthetic heart valve described in any example herein, particularly any one of Examples 19-27, wherein each strut in the first row of struts has a first width that is greater than the second width of each strut in the second row of struts.

[0190] Example 29. The prosthetic heart valve of any example herein, particularly Example 28, wherein the plurality of circumferentially extending angled strut rows further includes a fourth strut row at the inflow end of the frame, each strut of the fourth strut row having a third width that is less than the first width.

[0191] Example 30.A prosthetic heart valve comprising: a radially expandable and foldable annular frame including a plurality of interconnected struts defining a plurality of circumferentially extending cell rows disposed between an outflow end and an inflow end of the frame, the plurality of interconnected struts including a circumferentially extending first strut row defining an outflow end, each first strut including two angled strut sections interconnected by an outflow apex region, the outflow apex region curved between the two angled strut sections and having a width that is narrowed relative to the widths of the two angled strut sections; a plurality of axially extending struts circumferentially spaced about the frame and connected to the first row of struts; and a circumferentially extending row of angled second struts disposed upstream of the first row of struts, wherein first portions of the second struts of the angled second row of struts are each directly connected to a respective axially extending strut of the plurality of axially extending struts, and wherein second portions of the second struts of the angled second row of struts form pairs of second struts connected together by free vertex regions not attached to the plurality of axially extending struts, and the free apex region has a first surface facing a downstream direction and an opposing second surface facing an upstream direction, the first surface curved between each pair of second struts, the second surface concave inward toward the first surface such that a width of the free apex region between the first and second surfaces is less than a width of each pair of second struts; and the circumferentially extending row of angled second struts and the circumferentially extending row of angled third struts, the first row of struts, the axially extending struts, and the angled second row of struts being a first row of cells among a plurality of rows of cells disposed at the outflow end. a frame, the frame forming a second row of cells among a plurality of rows of cells disposed adjacent to the first row of cells, the second row of angled struts and the third row of angled struts forming a second row of cells among a plurality of rows of cells disposed adjacent to the first row of cells, the first width of each cell of the first row of cells being greater than the second width of each cell of the second row of cells; and a plurality of leaflets fixed to the inside of the frame and configured to open and close to regulate blood flow through the prosthetic heart valve from the inflow end to the outflow end of the frame, wherein each free apex region of the second row of angled struts is positioned at the level of a portion of the plurality of leaflets that open and close during operation of the prosthetic heart valve.

[0192] Example 31 The prosthetic heart valve of any example herein, particularly example 30, wherein the first surface of each free vertex region has a constant convex curvature between the downstream-facing surfaces of each pair of second struts.

[0193] Example 32. A prosthetic heart valve as described in any example herein, particularly either Example 30 or Example 31, wherein the outflow apex region of each first strut forms an angle between the two angled strut portions that is greater than 120 degrees.

[0194] Example 33. A prosthetic heart valve as described in any of the examples herein, particularly any one of Examples 30-32, wherein the first surface of the outflow apex region of each first strut facing away from the inflow end of the frame forms a single continuous curve having a convex curvature from one of the two angled strut portions on the first side of the outflow apex region to another of the two angled strut portions on the second side of the outflow apex region.

[0195] Example 34. The prosthetic heart valve of any example herein, particularly any one of Examples 30-33, wherein the first width is twice as wide as the second width.

[0196] Example 35. A prosthetic heart valve described in any example herein, particularly any one of Examples 30-34, wherein each cell in the first cell row has a first axial length that is longer than the second axial length of each cell in the second cell row.

[0197] Example 36. A prosthetic heart valve described in any example herein, particularly any one of Examples 30 to 35, wherein the frame is radially expandable and foldable between a radially expanded configuration and a radially folded configuration, and the frame further includes a plurality of horizontal struts extending between adjacent cells of the second cell row, each horizontal strut of the plurality of horizontal struts connecting together two adjacent second struts of the angled second strut row and two adjacent third struts of the angled third strut row, and configured to maintain a specified circumferential gap between two adjacent second struts and two adjacent third struts when the frame is in the radially folded configuration.

[0198] Example 37. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 30-36, wherein the width of the two angled strut portions of each first strut in the first strut row is greater than the width of each second strut in the angled second strut row.

[0199] Example 38. The prosthetic heart valve of any example herein, particularly example 37, wherein the plurality of interconnected struts further comprises a circumferentially extending row of angled fourth struts at the inflow end of the frame, each fourth strut of the angled fourth strut row having a width less than the width of the two angled strut portions of each first strut.

[0200] Example 39. An assembly, comprising: a delivery device comprising a balloon; and an implantable prosthetic heart valve radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, wherein the prosthetic heart valve comprises a radially expandable and compressible annular frame including a plurality of interconnected angled struts defining a plurality of circumferentially extending cell rows disposed between an outflow end and an inflow end of the frame, wherein the plurality of interconnected angled struts are arranged to form a plurality of circumferentially extending strut rows, including a first strut row at the outflow end of the frame, a second strut row upstream of the first strut row, and a third strut row upstream of the second strut row, wherein the plurality of circumferentially extending cell rows comprises a first row of first cells disposed at the outflow end and defined at least in part by the first strut row and the second strut row, and a third strut row upstream of the first row of first cells. and a second row of second cells defined at least in part by the second row of struts and the third row of struts, wherein each first cell of the first row of first cells has a first width greater than a second width of each second cell of the second row of second cells, the second row of struts including a plurality of free apex regions, each free apex region connecting together the angled struts of a respective pair of the second row of struts and having a first surface facing the outflow end of the frame and an opposing second surface facing the inflow end of the frame, the first surfaces forming a single continuous convex curve from one angled strut of each pair of angled struts on the first side of the free apex region to the other angled strut of each pair of angled struts on the opposite second side of the free apex region, the folded prosthetic heart valve being mounted around a balloon and capable of being radially expanded to an expanded configuration while the balloon is within a patient's body.

[0201] Example 40. The assembly of any example herein, particularly example 39, wherein each free vertex region has a width between the first and second surfaces of the free vertex region that is less than the width of each pair of angled struts.

[0202] Example 41. An assembly as described in any example herein, particularly either Example 39 or Example 40, wherein the second surface of each free vertex region defines a recess between the first and second sides of the free vertex region, such that the width of the free vertex region between the first and second surfaces is less than the width of each pair of angled struts.

[0203] Example 42. The assembly of any example herein, particularly any one of Examples 39-41, wherein the first width is twice the second width.

[0204] Example 43. The assembly of any example herein, particularly any one of Examples 39-41, wherein the first row of first cells includes half the number of cells included in the second row of second cells.

[0205] Example 44. The assembly of any example herein, particularly any one of Examples 39-43, wherein the frame further comprises a plurality of axially extending struts extending between the first row of struts and the second row of struts and defining axial sides of the first row of first cells.

[0206] Example 45. The assembly of any example herein, particularly example 44, wherein first portions of the struts in the second row of struts form pairs of angled struts each connected to a respective axially extending strut of the plurality of axially extending struts, and second portions of the struts in the second row of struts form pairs of angled struts connected by a respective free vertex region of the plurality of vertex regions, and the plurality of free vertex regions are not attached to the plurality of axially extending struts.

[0207] Example 46. An assembly as described in any example herein, particularly any of Example 44 or Example 45, further comprising a plurality of leaflets, each leaflet comprising opposing commissure tabs disposed on opposite sides of the leaflet and a leaflet edge portion extending between the opposing commissure tabs, a portion of the plurality of axially extending struts being axially extending window struts defining commissure windows, and the commissure tabs of adjacent leaflets pair together and are secured to respective commissure windows of the frame.

[0208] Example 47. An assembly described in any example herein, particularly any one of Examples 39-46, wherein the first row of struts forms pairs of angled struts, the struts in each pair of angled struts being connected together at their adjacent ends by an outflow apex region, the outflow apex region being curved between the pair of angled struts and having a narrowed width compared to the pair of angled struts.

[0209] Example 48. The assembly of any example herein, particularly Example 47, wherein the outflow apex region has a third surface and an opposing fourth surface facing the inflow end of the frame, the third surface having a constant convex curvature extending between the pair of angled struts.

[0210] Example 49. The assembly of any example herein, particularly any one of Examples 39-48, wherein each first cell in the first row of first cells has a first axial length that is longer than the second axial length of each second cell in the second row of second cells.

[0211] Example 50. The assembly of any example herein, particularly any one of Examples 39-49, wherein the frame further includes a plurality of horizontal struts extending between adjacent second cells in the second row of second cells, each horizontal strut of the plurality of horizontal struts connecting two adjacent struts in the second row of struts to two adjacent struts in the third row of struts.

[0212] Example 51. The assembly of any example herein, particularly example 50, wherein the circumferential length of each horizontal strut is specified to maintain a specific gap between two adjacent struts in the second row of struts and two adjacent struts in the third row of struts when the frame is in a collapsed configuration, and in the collapsed configuration, the first row of struts, the second row of struts, and the third row of struts assume a more axially expanded configuration than when the frame is in an expanded configuration.

[0213] Example 52. The assembly of any example herein, particularly any one of Examples 39-51, wherein each strut in the first row of struts has a first width that is greater than the second width of each strut in the second row of struts.

[0214] Example 53. The assembly of any example herein, particularly example 52, wherein the plurality of circumferentially extending rows of struts further includes a fourth row of struts at the inflow end of the frame, each strut of the fourth row of struts having a third width that is smaller than the first width and greater than the second width.

[0215] Example 54. An assembly described in any of the examples herein, particularly any one of Examples 39 to 53, wherein the prosthetic heart valve further comprises a plurality of leaflets fixed inside the frame and configured to open and close to regulate the flow of blood through the prosthetic heart valve from the inflow end to the outflow end of the frame, and each free apex region of the second row of struts is positioned at the level of a portion of the plurality of leaflets that open and close during operation of the prosthetic heart valve.

[0216] Example 55. A prosthetic heart valve comprising a radially expandable and compressible annular frame including a plurality of interconnected angled struts defining a plurality of circumferentially extending cell rows disposed between a first end and a second end of the frame, wherein the plurality of interconnected angled struts are arranged to form a plurality of circumferentially extending strut rows including a first strut row at the first end of the frame, a second strut row disposed adjacent to the first strut row, and a third strut row disposed adjacent to the second strut row, the second strut row being disposed between the first and third strut rows, and the plurality of circumferentially extending cell rows are disposed at the first end and are defined by at least the first and second strut rows. and a second row of second cells disposed adjacent to the first row of first cells and defined at least in part by the second row of struts and the third row of struts, each first cell of the first row of first cells having a first width greater than a second width of each second cell of the second row of second cells, the second row of struts including a plurality of free apex regions, each free apex region connecting adjacent ends of a respective pair of angled struts of the first row of struts together, and having a first surface facing the first end of the frame and an opposing second surface facing the second end of the frame, the first surface having a constant convex curvature extending between the adjacent ends of each pair of angled struts.

[0217] Example 56. A prosthetic heart valve as described in any example herein, particularly example 55, wherein the second surface of each free apex region defines a concave region between adjacent ends of each pair of angled struts such that the width of the free apex region between the first surface and the second surface is smaller than the width of each pair of angled struts.

[0218] Example 57. A prosthetic heart valve as described in any of the examples herein, particularly example 55 or example 56, wherein the first surface of the free apex region forms a single continuous curve from the surface of the first angled strut of each pair of angled struts facing the first end of the frame and positioned on a first side of the free apex region to the surface of the second angled strut of each pair of angled struts facing the second end of the frame and positioned on the opposite second side of the free apex region.

[0219] Example 58. The prosthetic heart valve of any example herein, particularly any one of Examples 55-57, wherein the first width is twice as wide as the second width.

[0220] Example 59. The prosthetic heart valve of any example herein, particularly any one of Examples 55-58, wherein the first row of first cells comprises 6 cells and the second row of second cells comprises 12 cells.

[0221] Example 60. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 55-59, wherein the frame further comprises a plurality of axially extending struts extending between the first and second rows of struts and defining the axial sides of the first row of first cells.

[0222] Example 61. A prosthetic heart valve as described in any example herein, particularly example 60, wherein first portions of the struts in the second row of struts form pairs of angled struts that are each connected to a respective axially extending strut of the plurality of axially extending struts, and second portions of the struts in the second row of struts form pairs of angled struts that are connected by a respective free apex region of the plurality of apex regions, and the plurality of free apex regions are not attached to the plurality of axially extending struts.

[0223] Example 62. A prosthetic heart valve as described in any example herein, particularly any of Example 60 or Example 61, wherein a portion of the plurality of axially extending struts are axially extending window struts that define commissure windows, and further comprising a plurality of leaflets secured together on their adjacent sides to form commissure portions, the commissure portions being secured to the commissure windows of the frame.

[0224] Example 63. A prosthetic heart valve described in any example herein, particularly any one of Examples 55-62, wherein the first strut row forms pairs of angled struts, the struts of each pair of angled struts being connected together at their adjacent ends by an outflow apex region, the outflow apex region being curved between the pair of angled struts and having a narrowed width compared to the pair of angled struts.

[0225] Example 64. The prosthetic heart valve of any example herein, particularly example 63, wherein the outflow apex region has a third surface and an opposing fourth surface facing the second end of the frame, the third surface having a constant convex curvature extending between the pair of angled struts.

[0226] Example 65. A prosthetic heart valve described in any example herein, particularly any one of Examples 55-64, wherein each first cell of the first row of first cells has a first axial length that is longer than the second axial length of each second cell of the second row of second cells.

[0227] Example 66. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 55 to 65, wherein the frame further includes a plurality of horizontal struts extending between adjacent second cells of the second row of second cells, each horizontal strut of the plurality of horizontal struts connecting two adjacent struts of the second row of struts to two adjacent struts of the third row of struts.

[0228] Example 67. The prosthetic heart valve of any example herein, particularly example 66, wherein the circumferential length of each horizontal strut is specified to maintain a specified gap between two adjacent struts in the second row of struts and two adjacent struts in the third row of struts when the frame is in a radially compressed configuration.

[0229] Example 68. The prosthetic heart valve of any example herein, particularly example 67, wherein in the radially compressed configuration, the second and third strut rows are axially oriented in a relatively straight, perpendicular orientation relative to the central longitudinal axis of the frame.

[0230] Example 69. The prosthetic heart valve of any example herein, particularly example 67, wherein in the radially compressed configuration, the second and third rows of struts extend axially but are angled inwardly toward each other with adjacent horizontal struts.

[0231] Example 70. A prosthetic heart valve described in any example herein, particularly any one of Examples 55-69, wherein each strut in the first row of struts has a first width that is greater than the second width of each strut in the second row of struts.

[0232] Example 71. The prosthetic heart valve of any example herein, particularly example 70, wherein the plurality of circumferentially extending rows of struts further includes a fourth row of struts at a second end of the frame, and each strut of the fourth row of struts has a third width that is smaller than the first width and greater than the second width.

[0233] Example 72. A prosthetic heart valve as described in any of the examples herein, particularly any one of Examples 55 to 71, further comprising a plurality of valve leaflets fixed to the inside of the frame and configured to open and close to regulate the flow of blood through the prosthetic heart valve from the second end to the first end of the frame, wherein each free apex region of the second row of struts is positioned at the level of a portion of the plurality of valve leaflets that open and close during operation of the prosthetic heart valve.

[0234] Example 73. A prosthetic heart valve according to any example herein, particularly any one of Examples 55-72, wherein the first end is the outflow end of the frame and the second end is the inflow end of the frame.

[0235] Example 74. A prosthetic heart valve comprising a radially expandable and compressible annular frame including a plurality of interconnected struts defining a plurality of circumferentially extending cell rows disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts comprising a circumferentially extending row of outflow struts defining an outflow end, each outflow strut including two angled strut portions interconnected by an apex region, each inflow strut having a curved and narrowed width between a corresponding pair of the two angled strut portions and a length extending along at least 25% of the total length of the outflow strut, a circumferentially extending row of outflow struts defining an outflow end, the combined width of the two angled strut segments being less than the width of the two angled strut segments; and a first circumferentially extending, angled row of struts disposed upstream of the outflow strut row, the outflow strut row and the angled first row of struts at least partially forming a first row of cells of a plurality of circumferentially extending rows of cells disposed at the outflow end, each cell of the first row of cells having a first width greater than second widths of the remaining rows of cells of the plurality of circumferentially extending rows of cells.

[0236] Example 75 The prosthetic heart valve of any example herein, particularly example 74, wherein the first width is two times greater than the second width.

[0237] Example 76. A prosthetic heart valve as described in any example herein, particularly either example 74 or example 75, wherein the plurality of interconnected struts further includes a circumferentially extending row of angled second struts positioned upstream of the first angled row of struts, the first angled row of struts and the second angled row of struts forming a second row of cells among the plurality of rows of cells positioned adjacent to and upstream of the first row of cells, and each cell of the second row of cells having a second width that is half the first width.

[0238] Example 77. A prosthetic heart valve as described in any example herein, particularly example 76, wherein a portion of the first struts of the angled first strut row form pairs of first struts connected together by free apex regions not attached to additional struts forming the first cell row, and wherein the free apex regions of each respective pair of second struts have a first surface facing a downstream direction and an opposing second surface facing an upstream direction, the first surface curved between each pair of second struts, and the second surface concave inward toward the first surface such that the width of the free apex region between the first surface and the second surface is smaller than the width of each pair of second struts.

[0239] Example 78. A prosthetic heart valve as described in any of the examples herein, particularly any one of Examples 74-77, further comprising a plurality of axially extending struts, the plurality of interconnected struts extending between the outflow strut row and the angled first strut row and defining the axial sides of the first cell row.

[0240] Example 79. The prosthetic heart valve of any example herein, particularly any one of Examples 74-78, wherein each cell in the first cell row has a longer axial length than the cells in the remaining cell rows.

[0241] Example 80. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 74 to 79, further comprising a plurality of valve leaflets fixed to the inside of the frame and configured to open and close to regulate the flow of blood through the prosthetic heart valve from the inflow end to the outflow end of the frame.

[0242] Example 81. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 74-80, wherein the narrowed width of each apex region is 0.06 mm to 0.15 mm less than the width of the two angled strut portions.

[0243] Example 82. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 1 to 81, further comprising an inner skirt disposed around the inner surface of the frame, the outflow edge portion of the inner skirt being fixed to the second row of struts, and in each free apex region, the outflow edge portion being disposed upstream of the free apex region.

[0244] Example 83. A prosthetic heart valve as described in any example herein, particularly example 82, wherein the outflow edge portion of the inner skirt is folded over on itself so that the outflow edge of the inner skirt is positioned between the inner surface of the frame and an adjacent portion of the inner skirt.

[0245] Example 84. A prosthetic heart valve as described in any example herein, particularly either example 82 or example 83, wherein the outflow edge portion of the inner skirt is secured to the second row of struts with a plurality of stitches.

[0246] Example 85. The prosthetic heart valve of any example herein, particularly any one of Examples 82-84, wherein each apex region is not covered by an inner skirt.

[0247] Example 86. A prosthetic heart valve comprising a radially expandable and compressible annular frame including a plurality of interconnected angled struts defining a plurality of circumferentially extending cell rows disposed between a first end and a second end of the frame, wherein the plurality of interconnected angled struts are arranged to form a plurality of circumferentially extending strut rows, including a first strut row at the first end of the frame, a second strut row disposed adjacent to the first strut row, and a third strut row disposed adjacent to the second strut row, the second strut row being disposed between the first strut row and the third strut row, and the plurality of circumferentially extending cell rows comprising a first row of first cells disposed at the first end and defined at least in part by the first strut row and the second strut row, and a third row of first cells. and a second row of second cells disposed adjacent to the first row of first cells and defined at least in part by a second row of struts and a third row of struts, wherein each first cell of the first row of first cells has a first width greater than a second width of each second cell of the second row of second cells, the second row of struts including a plurality of free vertices, each free vertex connecting adjacent ends of a respective pair of angled struts in the second row of struts together; and an inner skirt disposed around an inner surface of the frame, a first end of the inner skirt fixed to the second row of struts, and at each free vertex, a first edge portion is disposed away from the free vertex toward a second end of the frame, and a second edge portion of the inner skirt is disposed at the second end of the frame.

[0248] Example 87. The prosthetic heart valve of any example herein, particularly example 86, wherein the first edge portion of the inner skirt is folded over on itself so that the outer first edge of the inner skirt is positioned between the inner surface of the frame and an adjacent portion of the inner skirt.

[0249] Example 88. A prosthetic heart valve as described in any example herein, particularly any of Example 86 or Example 87, wherein the first edge portion of the inner skirt is secured to the second row of struts with a plurality of stitches.

[0250] Example 89. A prosthetic heart valve according to any of the examples herein, particularly any one of Examples 86-88, wherein each free apex is not covered by an inner skirt.

[0251] Example 90. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 86 to 89, wherein the first end of the frame is the outflow end, the second end of the frame is the inflow end, the first edge portion of the inner skirt is the outflow edge portion, and at each free apex, the outflow edge portion of the inner skirt is located upstream of the free apex.

[0252] Example 91. A prosthetic heart valve described in any example herein, particularly any one of Examples 86 to 90, wherein each free apex has a first surface facing a first end of the frame and an opposing second surface facing a second end of the frame, the first surface having a constant convex curvature extending between adjacent ends of each pair of angled struts.

[0253] Example 92. A prosthetic heart valve comprising: a radially expandable and compressible annular frame including a plurality of interconnected angled struts arranged to form a plurality of circumferentially extending strut rows, including a first row of struts, a second row of struts downstream of the first row of struts, and a third row of struts downstream of the second row of struts; and an inner skirt disposed around an inner surface of the frame, the skirt including an inflow edge and an outflow edge, the outflow edge being sewn to the struts of the second row of struts and including a plurality of circumferentially spaced apart peaks, the peaks aligned with respective apexes of the second row of struts, and at least one peak having a linear edge spaced apart from its respective apex toward the inflow end of the frame.

[0254] Example 93 The prosthetic heart valve of any example herein, particularly example 92, wherein at least one peak is folded to form a crease that forms a straight edge.

[0255] Example 94. A prosthetic heart valve described in any of the examples herein, particularly any one of Example 92 or Example 93, wherein a first set of apexes of the second strut row are connected to the struts of the third strut row by axially extending struts, and a second set of apexes of the second strut row are free apexes that do not include any axially extending struts connected to the third strut row, and the outflow edge of the skirt includes a plurality of first peaks aligned with the apexes of the first set of apexes and a plurality of second peaks having linear edges aligned with each free apex of the second strut row.

[0256] Example 95 The prosthetic heart valve of any example herein, particularly example 94, wherein each second peak is disposed between a corresponding adjacent first peak.

[0257] Example 96. A prosthetic heart valve according to any example herein, particularly any one of Examples 94-95, wherein the first peak is sharp.

[0258] Example 97. A prosthetic heart valve described in any example herein, particularly any one of Examples 94-96, wherein the first peak extends axially toward the outflow end of the frame to a greater extent than the second peak.

[0259] Example 98. The prosthetic heart valve of any example herein, particularly any one of Examples 94-97, wherein the second peak is folded and the first peak is unfolded.

[0260] Example 99. A prosthetic heart valve described in any example herein, particularly any one of Examples 94 to 98, wherein each free apex of the free apexes connects adjacent ends of a respective pair of struts in the second strut row, each free apex having a first surface facing in a downstream direction and an opposing second surface facing in an upstream direction, the first surface having a constant convex curvature extending between adjacent ends of each pair of struts.

[0261] Example 100. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 94 to 99, further comprising a plurality of valve leaflets fixed to the inside of the frame and configured to open and close to regulate the flow of blood through the prosthetic heart valve from the inflow end to the outflow end of the frame, wherein each free apex of the second row of struts is positioned at the level of a portion of the plurality of valve leaflets that open and close during operation of the prosthetic heart valve.

[0262] Example 101. A prosthetic heart valve described in any example herein, particularly any one of Examples 92-100, wherein the frame includes a plurality of circumferentially extending cell rows, including an outflow row of first cells defined at least in part by a second row of struts and a third row of struts, and a second row of second cells upstream of the first row of first cells and defined at least in part by the first row of struts and the second row of struts, and wherein each first cell of the first row of first cells has a first width that is greater than the second width of each second cell of the second row of second cells.

[0263] Example 102 The prosthetic heart valve of any example herein, particularly example 101, wherein the first width is twice the second width.

[0264] Example 103. The prosthetic heart valve of any example herein, particularly any one of Examples 92-102, further comprising an outer skirt disposed around the outer surface of the frame.

[0265] Example 104. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 92 to 103, wherein the frame is radially expandable and compressible between a radially expanded configuration and a radially compressed configuration, and wherein when the frame is radially compressed and slides downstream on the frame, but not to the respective apex region, the linear edge of at least one peak is configured to slide upstream on the frame, further upstream from the respective apex region.

[0266] Example 105. A prosthetic heart valve comprising a radially expandable and compressible annular frame including a plurality of interconnected angled struts defining a plurality of circumferentially extending cell rows disposed between an outflow end and an inflow end of the frame, the plurality of interconnected angled struts being arranged to form a plurality of circumferentially extending strut rows, including a first strut row at the outflow end of the frame, a second strut row upstream of the first strut row, and a third strut row upstream of the second strut row, and a plurality of circumferentially extending cell rows are disposed at the outflow end and extend axially to interconnect the struts of the first and second strut rows and the first and second strut rows. 1. A prosthetic heart valve comprising: a first row of first cells at least partially defined by struts; and a second row of second cells disposed upstream of the first row of first cells and at least partially defined by a second row of struts and a third row of struts, the second row of struts including a plurality of free apex regions not connected to struts of the first row of struts by axially extending struts, each free apex region connecting adjacent ends of a respective pair of angled struts of the second row of struts together and having a first surface facing a downstream direction, an opposing second surface facing an upstream direction, and a width measured from the first surface to the second surface, the width being less than the width of the struts connected by the free apex regions.

[0267] Example 106 The prosthetic heart valve of any example herein, particularly example 105, wherein the first surface has a constant convex curvature extending between adjacent ends of each pair of angled struts.

[0268] Example 107. The prosthetic heart valve of any one of claims 105-106, wherein the first cells are wider than the second cells.

[0269] Example 108. The prosthetic heart valve of any one of claims 105 to 107, wherein the second surface forms a recess in the free apex region.

[0270] Example 109. The prosthetic heart valve of any example herein, particularly any one of Examples 105-108, wherein the second row of second cells has twice the number of cells as the first row of first cells.

[0271] Example 110. A prosthetic heart valve described in any one of Examples 105 to 109, wherein a portion of the axially extending strut is an axially extending window strut defining a commissure window, and further comprising a plurality of leaflets fixed together at their adjacent sides to form a commissure portion, the commissure portion being fixed to the commissure window of the frame.

[0272] Example 111. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 105-110, wherein the first row of struts forms pairs of angled struts, the struts of each pair of the first row of angled struts being connected together at their adjacent ends by an outflow apex region, the outflow apex region being curved between the pair of angled struts and having a narrowed width compared to the pair of angled struts.

[0273] Example 112. A prosthetic heart valve as described in any example herein, particularly example 111, wherein the outflow apex region has a third surface and an opposing fourth surface facing an upstream direction, the third surface having a constant convex curvature extending between the pair of angled struts.

[0274] Example 113. A prosthetic heart valve described in any example herein, particularly any one of Examples 105-112, wherein each first cell of the first row of first cells has a first axial length that is longer than the second axial length of each second cell of the second row of second cells.

[0275] Example 114. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 105 to 113, wherein the frame further includes a plurality of horizontal struts extending between adjacent second cells of the second row of second cells, each horizontal strut of the plurality of horizontal struts connecting two adjacent struts of the second row of struts to two adjacent struts of the third row of struts.

[0276] Example 115. The prosthetic heart valve of any example herein, particularly example 114, wherein the circumferential length of each horizontal strut is specified to maintain a specified gap between two adjacent struts in the second row of struts and two adjacent struts in the third row of struts when the frame is in a radially compressed configuration.

[0277] Example 116. A prosthetic heart valve as described in any example herein, particularly example 115, wherein in the radially compressed configuration, the second and third strut rows are axially oriented in a relatively straight, perpendicular orientation relative to the central longitudinal axis of the frame.

[0278] Example 117. The prosthetic heart valve of any example herein, particularly example 116, wherein in the radially compressed configuration, the second and third rows of struts extend axially but are angled inwardly toward each other with adjacent horizontal struts.

[0279] Example 118. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 105-117, wherein each strut in the first row of struts has a first width that is greater than the second width of each strut in the second row of struts.

[0280] Example 119. A prosthetic heart valve as described in any example herein, particularly example 118, wherein the plurality of circumferentially extending strut rows further includes a fourth strut row at the inflow end of the frame, and each strut of the fourth strut row has a third width that is smaller than the first width and greater than the second width.

[0281] Example 120. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 105 to 119, further comprising a plurality of valve leaflets fixed to the inside of the frame and configured to open and close to regulate the flow of blood through the prosthetic heart valve from the inflow end to the outflow end of the frame, wherein each free apex region of the second row of struts is positioned at the level of a portion of the plurality of valve leaflets that open and close during operation of the prosthetic heart valve.

[0282] Example 121. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 105 to 120, further comprising an inner skirt disposed around the inner surface of the frame, the outflow edge portion of the inner skirt being fixed to the second row of struts, and at each free apex region, the outflow edge portion being disposed upstream of the free apex region.

[0283] Example 122. A prosthetic heart valve as described in any example herein, particularly example 121, wherein the outflow edge portion comprises a plurality of peaks spaced apart from one another in the circumferential direction, with portions of the peaks aligned with and spaced apart from the respective apex regions toward the inflow end of the frame.

[0284] Example 123. A prosthetic heart valve described in any of the examples herein, particularly any one of Example 121 or Example 122, wherein at each free apex region, the outflow edge portion is folded against the frame to form a straight edge spaced apart from and upstream of the free apex region.

[0285] Example 124. A prosthetic heart valve described in any of the examples herein, particularly any one of Examples 121-124, wherein the outflow edge portion of the inner skirt is secured to the second row of struts with a plurality of stitches.

[0286] Example 125. A method comprising sterilizing the prosthetic heart valve, device, and / or assembly of any example.

[0287] Example 126. The prosthetic heart valve of any one of Examples 1 to 124, wherein the prosthetic heart valve is sterilized.

[0288] Features described herein with respect to any example may be combined with other features described in any one or more examples in other examples, unless otherwise stated. For example, any one or more features of one prosthetic valve frame may be combined with any one or more features of another prosthetic valve frame.

[0289] In view of the many possible ways in which the principles of the present disclosure may be applied, it will be recognized that the illustrated configurations are illustrative examples of the disclosed technology and should not be taken as limiting the scope of the present disclosure or the claims that follow. Rather, the scope of claimed subject matter is defined by the following claims and their equivalents.

Claims

1. 1. A prosthetic heart valve, comprising: a radially expandable and compressible annular frame including a plurality of interconnected angled struts defining a plurality of circumferentially extending rows of cells disposed between a first end and a second end of the frame; the plurality of interconnected angled struts are arranged to form a plurality of circumferentially extending strut rows, including a first strut row at the first end of the frame, a second strut row disposed adjacent to the first strut row, and a third strut row disposed adjacent to the second strut row, the second strut row being disposed between the first strut row and the third strut row; the plurality of circumferentially extending cell rows a first row of first cells disposed at the first end and at least partially defined by the first row of posts and a second row of posts; a second row of second cells disposed adjacent to the first row of first cells and defined at least in part by the second row of struts and a third row of struts; 1. A prosthetic heart valve, wherein each first cell of the first row of first cells has a first width greater than a second width of each second cell of the second row of second cells, and wherein the second row of struts includes a plurality of free vertex regions, each free vertex region connecting adjacent ends of a respective pair of angled struts of the second row of struts together, and having a first surface facing the first end of the frame and an opposing second surface facing the second end of the frame, the first surface having a constant convex curvature extending between the adjacent ends of each pair of angled struts.

2. 2. The prosthetic heart valve of claim 1, wherein the second surface of each free vertex region defines a concave region between the adjacent ends of each pair of angled struts such that the width of the free vertex region between the first surface and the second surface is less than the width of each pair of angled struts.

3. 3. The prosthetic heart valve of claim 1, wherein the first surface of the free vertex region forms a single continuous curve from a surface of a first angled strut of each pair of the angled tributaries facing the first end of the frame and disposed on a first side of the free vertex region to a surface of a second angled strut of each pair of the angled struts facing the second end of the frame and disposed on an opposite second side of the free vertex region.

4. The prosthetic heart valve according to any one of claims 1 to 3, wherein the first width is twice as wide as the second width.

5. 5. The prosthetic heart valve of claim 1, wherein the frame further comprises a plurality of axially extending struts extending between the first and second rows of struts and defining axial sides of the first row of first cells.

6. 6. The prosthetic heart valve of claim 5, wherein a first portion of struts in the second row of struts form pairs of angled struts each connected to a respective axially extending strut of the plurality of axially extending struts, and a second portion of struts in the second row of struts form pairs of angled struts connected by a free apex region of each of the plurality of apex regions, the plurality of free apex regions not attached to the plurality of axially extending struts.

7. 7. The prosthetic heart valve of claim 5, wherein a portion of the plurality of axially extending struts are axially extending window struts that define commissure windows, and further comprising a plurality of leaflets secured together at their adjacent sides to form commissures, the commissures being secured to the commissure windows of the frame.

8. 8. The prosthetic heart valve of claim 1, wherein the first row of struts forms pairs of angled struts, the struts of each pair of angled struts being connected together at their adjacent ends by an outflow apex region, the outflow apex region curving between the pair of angled struts and having a reduced width compared to the pair of angled struts.

9. 9. The prosthetic heart valve of claim 1, wherein each first cell of the first row of first cells has a first axial length that is longer than a second axial length of each second cell of the second row of second cells.

10. 10. The prosthetic heart valve of claim 1, wherein the frame further comprises a plurality of horizontal struts extending between adjacent second cells of the second row of second cells, each horizontal strut of the plurality of horizontal struts connecting two adjacent struts of the second row of struts to two adjacent struts of the third row of struts.

11. 11. The prosthetic heart valve according to claim 1, further comprising a plurality of leaflets fixed to the inside of the frame and configured to open and close to regulate the flow of blood through the prosthetic heart valve from the second end to the first end of the frame, wherein each free vertex region of the second row of struts is positioned at the level of a portion of the plurality of leaflets that open and close during operation of the prosthetic heart valve.

12. The prosthetic heart valve of any one of claims 1 to 11, wherein the first end is the outflow end of the frame and the second end is the inflow end of the frame.

13. 13. The prosthetic heart valve according to claim 1, further comprising an inner skirt disposed around an inner surface of the frame, the inner skirt having an outflow edge portion fixed to the second row of struts, and at each free apex region, the outflow edge portion being disposed upstream of the free apex region.

14. 1. A prosthetic heart valve, comprising: A radially expandable and collapsible annular frame including a plurality of interconnected struts disposed between an outflow end and an inflow end of the frame and defining a plurality of circumferentially extending rows of cells, the plurality of interconnected struts comprising: a first circumferentially extending row of struts defining the outflow end, each first strut including two angled strut portions interconnected by an outflow apex region, the outflow apex region curved between the two angled strut portions and having a width that is narrowed relative to the widths of the two angled strut portions; a plurality of axially extending struts circumferentially spaced about the frame and connected to the first row of struts; a circumferentially extending row of angled second struts disposed upstream of the first row of struts, wherein first portions of the second struts in the angled second row are each directly connected to a respective axially extending strut of the plurality of axially extending struts, and second portions of the second struts in the angled second row of struts form pairs of second struts connected together by free vertex regions not attached to the plurality of axially extending struts, the free vertex regions of each respective pair of second struts having a first surface facing a downstream direction and an opposing second surface facing an upstream direction, the first surface curved between each pair of second struts, the second surface concave inwardly toward the first surface such that a width of the free vertex region between the first surface and the second surface is less than a width of each pair of second struts; a frame including a third circumferentially extending, angled row of struts, wherein the first row of struts, the axially extending struts, and the second angled row of struts form a first row of cells of the plurality of rows of cells disposed at the outflow end, and the second angled row of struts and the third angled row of struts form a second row of cells of the plurality of rows of cells disposed adjacent to the first row of cells, and wherein a first width of each cell of the first row of cells is greater than a second width of each cell of the second row of cells; a plurality of leaflets fixed to the inside of the frame and configured to open and close to regulate blood flow through the prosthetic heart valve from the inflow end to the outflow end of the frame, wherein each free apex region of the angled second row of struts is positioned at the level of a portion of the plurality of leaflets that open and close during operation of the prosthetic heart valve.

15. 15. The prosthetic heart valve of claim 14, wherein the first surface of each free vertex region has a constant convex curvature between downstream-facing surfaces of each pair of the second struts.

16. 16. The prosthetic heart valve of claim 14, wherein a first surface of the outflow apex region of each first strut facing away from the inflow end of the frame forms a single continuous curve having a convex curvature from one of the two angled strut portions on a first side of the outflow apex region to another of the two angled strut portions on a second side of the outflow apex region.

17. The prosthetic heart valve of any one of claims 14 to 16, wherein the first width is twice as wide as the second width.

18. 1. A prosthetic heart valve, comprising: a radially expandable and compressible annular frame including a plurality of interconnected struts disposed between an inlet end and an outlet end of the frame and defining a plurality of circumferentially extending rows of cells, the plurality of interconnected struts comprising: an array of outflow struts defining the outflow end and extending circumferentially, each outflow strut including two angled strut sections interconnected by an apex region, each outflow apex region curved between a corresponding pair of two angled strut sections and having a narrowed width and a length extending along at least 25% of the total length of the outflow strut, the narrowed width being less than the widths of the two angled strut sections; a first circumferentially extending, angled row of struts disposed upstream of the outflow strut row, the outflow strut row and the angled first row of struts at least partially forming a first row of cells of the circumferentially extending plurality of cell rows disposed at the outflow end, each cell of the first row of cells having a first width greater than second widths of cells of the remaining rows of cells of the circumferentially extending plurality of cell rows.

19. 19. The prosthetic heart valve of claim 18, wherein the first width is twice as wide as the second width.

20. 20. The prosthetic heart valve of claim 18 or claim 19, wherein the plurality of interconnected struts further includes a second angled, circumferentially extending row of struts disposed upstream of the first angled row of struts, the first angled row of struts and the second angled row of struts forming a second row of cells in the plurality of rows of cells disposed adjacent to and upstream of the first row of cells, and each cell in the second row of cells having the second width that is half the first width.

21. 21. The prosthetic heart valve of claim 20, wherein a portion of first struts in the angled first row of struts form pairs of first struts connected together by free apex regions not attached to additional struts forming the first row of cells, and the free apex regions of each respective pair of second struts have a first surface facing a downstream direction and an opposing second surface facing an upstream direction, the first surface curved between each pair of second struts, and the second surface concave inwardly toward the first surface such that a width of the free apex region between the first surface and the second surface is less than a width of each pair of second struts.

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