Prosthetic heart valve

Abstract

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

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 401,538, filed on August 26, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to expandable prosthetic heart valves, including frames for prosthetic heart valves. Background Art

[0004] The human heart may suffer from various valvular diseases. These valvular diseases may cause significant dysfunction of the heart and ultimately require repairing the autologous valve or replacing the autologous valve with an artificial valve. There are many known repair devices (e.g., stents) and artificial valves, as well as many known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various surgeries to deliver prosthetic medical devices to a position that is not easily accessible by surgery or a position that is expected to be accessible without surgery. In a specific example, a prosthetic heart valve can be installed on the distal end of a delivery device in a crimped state and is advanced through the patient's vascular system (e.g., through the femoral artery and aorta) until the prosthetic valve reaches the implantation site in the heart. Then, for example, by expanding a balloon on which a prosthetic valve is installed, a mechanical actuator that applies an expansion force to the prosthetic valve is actuated, or by deploying a prosthetic valve from a sheath of a delivery device so that the prosthetic valve can be self-expanded to its functional size, the prosthetic valve is expanded to its functional size.

[0005] Most expandable prosthetic heart valves include a radially expandable and radially compressible cylindrical metal frame or stent and prosthetic leaflets mounted within the frame. In some examples, the prosthetic heart valve may include an inner skirt disposed around the interior of the frame, wherein the leaflets are secured to the inner skirt.

[0006] In some instances, a prosthetic heart valve can be implanted within the aortic root, which includes the right and left coronary ostia and is defined between the native aortic annulus and the sinotubular junction (STJ). The prosthetic heart valve can be implanted 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 partial occlusion of the coronary ostia due to the native aortic valve leaflets being pushed laterally during expansion of the prosthetic heart valve, the prosthetic 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., using a catheter) may become more difficult.

[0007] Therefore, a need exists for improved frame designs for prosthetic heart valves. Summary of the invention

[0008] Prosthetic heart valves, delivery devices, and methods for implanting prosthetic heart valves are described herein. Specifically, examples of radially expandable and radially compressible frames for prosthetic heart valves are described herein. The frame of the prosthetic heart valve may include a plurality of interconnected struts defining multiple rows of pores disposed between the outflow end and the inflow end of the frame. In some instances, a first row of pores disposed at the outflow end may have fewer pores than subsequent rows of the frame, such that the width of the pores in the first row of pores (in the circumferential direction) is greater than the width of the pores in the subsequent rows. Therefore, the pores in the second row of pores adjacent to the first row of pores may have exposed (or free) vertices and are not attached to additional struts defining the first row of pores. In some instances, these vertices may have a curved profile with a constant convex curvature between the angled struts or strut portions to which they are connected, similar to the vertices or vertex regions of the first row of pores at the outflow end of the frame. Thus, these apexes or apex regions can be more atraumatic and not interfere with the leaflets of the prosthetic heart valve as the leaflets open and close during operation of the prosthetic heart valve. In some examples, an inner skirt can be disposed about the inner surface of the frame, wherein the outflow edge of the inner skirt is secured to struts forming the first and second rows of pores and disposed below (upstream or toward the inflow end of the frame) the exposed apexes or apex regions. Thus, the devices and methods disclosed herein can overcome, among other things, one or more deficiencies of typical prosthetic heart valves.

[0009] The prosthetic heart valve may include a frame, and a valve 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.

[0010] In some instances, a frame can include a plurality of interconnected angled struts defining a plurality of rows of circumferentially extending pore chambers arranged 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 rows of circumferentially extending struts, 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, and a third row of struts upstream of the second row of struts.

[0011] In some instances, the multiple rows of circumferentially extending pores include: a first row of first pores, the first row of first pores being disposed at the outflow end and being at least partially defined by the first row of struts and the second row of struts; and a second row of second pores, the second row of second pores being disposed upstream of the first row of first pores and being at least partially defined by the second row of struts and the third row of struts, wherein a first width of each first pore in the first row of first pores is greater than a second width of each second pore in the second row of second pores.

[0012] In some examples, the second row of struts includes a plurality of free apex regions, and each free apex region connects together adjacent ends of a corresponding pair of angled struts in the second row of struts.

[0013] In some examples, each free apex region has a first surface facing in a downstream direction and an opposing second surface facing in an upstream direction, wherein the first surface has a constant convex curvature extending between the adjacent ends of the corresponding pair of angled struts.

[0014] In some examples, the plurality of interconnected struts further comprises a plurality of axially extending struts spaced circumferentially around the frame and connected to the first row of struts. The first portion of the angled struts in the second row of struts are each directly connected to a corresponding axially extending strut in the plurality of axially extending struts. The second portion of the angled struts in the second row of struts form pairs of angled struts connected together by free apex regions that are not attached to the plurality of axially extending struts.

[0015] In some examples, the prosthetic heart valve can include an inner skirt disposed around an inner surface of the frame, wherein an outflow edge portion of the inner skirt is secured to the second row of struts, and wherein at each free apex region, the outflow edge portion is disposed upstream of the free apex region.

[0016] In some examples, a prosthetic heart valve comprises a radially expandable and radially compressible annular frame, the radially expandable and radially compressible annular frame comprising a plurality of interconnected angled struts, the plurality of interconnected angled struts defining a plurality of rows of circumferentially extending pores 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 rows of circumferentially extending struts, 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, and a third row of struts upstream of the second row of struts. The plurality of rows of circumferentially extending pores comprises: a first row of first pores disposed at the outflow end and at least partially defined by the first row of struts and the second row of struts; and a second row of second pores disposed upstream of the first row of first pores and at least partially defined by the second row of struts and the third row of struts, wherein a first width of each first pore in the first row of first pores is greater than a second width of each second pore in the second row of second pores. The second row of struts includes a plurality of free apex regions, and each free apex region connects together adjacent ends of a corresponding pair of angled struts in the second row of struts, and has a first surface facing a downstream direction and an opposite second surface facing an upstream direction, wherein the first surface has a constant convex curvature extending between the adjacent ends of the corresponding pair of angled struts.

[0017] In some examples, a prosthetic heart valve comprises a radially expandable and radially collapsible annular frame, the radially expandable and radially collapsible annular frame comprising a plurality of interconnected struts, the plurality of interconnected struts defining a plurality of rows of circumferentially extending pores disposed between an outflow end and an inflow end of the frame. The plurality of interconnected struts comprises a plurality of rows of circumferentially extending angled struts, the plurality of rows of circumferentially extending angled struts comprising a first row of struts at the outflow end of the frame, a second row of struts upstream of the first row of struts, and a third row of struts upstream of the second row of struts, and a plurality of axial struts circumferentially spaced around the frame and extending between the first row of struts and the second row of struts. The plurality of rows of circumferentially extending pores comprises: a first row of first pores disposed at the outflow end and at least partially defined by the first row of struts and the second row of struts and the plurality of axial struts; and a second row of second pores disposed upstream of the first row of first pores and at least partially defined by the second row of struts and the third row of struts. The first width of each first cell in the first row of first cells is greater than the second width of each second cell in the second row of second cells. The second row of second cells includes a first portion of a second cell defined by a first pair of angled columns of the second row of columns and a second portion of a second cell defined by a second pair of angled columns and a plurality of free apex regions of the second row of columns, the second row of columns being directly connected to the plurality of axial columns at their adjacent ends. Each free apex region connects the adjacent ends of the corresponding second pair of angled columns together and has a first surface facing in a downstream direction and an opposite second surface facing in an upstream direction, wherein the first surface has a constant convex curvature extending between the adjacent ends of the corresponding second pair of angled columns, and wherein the plurality of free apex regions are not attached to the plurality of axial columns.

[0018] In some examples, a prosthetic heart valve comprises a radially expandable and radially collapsible annular frame comprising a plurality of interconnected struts defining a plurality of rows of circumferentially extending pores disposed between an outflow end and an inflow end of the frame. The plurality of interconnected struts comprises a row of circumferentially extending first struts defining the outflow end, each first strut comprising two angled strut portions interconnected by an outflow apex region, wherein the outflow apex region bends between the two angled strut portions and has a narrowed width relative to the width of the two angled strut portions. The plurality of interconnected struts further comprises a plurality of axially extending struts spaced circumferentially around the frame and connected to the row of first struts; and a row of circumferentially extending angled second struts disposed upstream of the row of first struts. Each of the first portion of the second struts in the row of angled second struts is directly connected to a corresponding axially extending strut in the plurality of axially extending struts. The second struts of the second portion of the row of angled second struts form pairs of second struts connected together by free apex regions that are not attached to the plurality of axially extending struts, wherein the free apex regions of each corresponding pair of second struts have a first surface facing in a downstream direction and an opposite second surface facing in an upstream direction, wherein the first surface is curved between the corresponding pair of second struts, and wherein the second surface is recessed inwardly toward the first surface so that the width of the free apex region between the first surface and the second surface is less than the width of the corresponding pair of second struts. The plurality of interconnected struts further include a row of circumferentially extending angled third struts, wherein the row of first struts, the axially extending struts and the row of angled second struts form a first row of pores of the plurality of rows of pores disposed at the outflow end, wherein the row of angled second struts and the row of angled third struts form a second row of pores of the plurality of rows of pores disposed adjacent to the first row of pores, and wherein the first width of each pore in the first row of pores is wider than the second width of each pore in the second row of pores. The prosthetic heart valve further includes a plurality of leaflets secured to an interior of the frame and configured to open and close to regulate the flow of blood from the inflow end of the frame through the prosthetic heart valve to the outflow end, wherein each free apex region of the row of angled second struts is positioned at the level of a portion of the plurality of leaflets that opens and closes during operation of the prosthetic heart valve.

[0019] In some examples, a prosthetic heart valve comprises a radially expandable and radially compressible annular frame comprising a plurality of interconnected angled struts defining a plurality of rows of circumferentially extending pores 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 rows of circumferentially extending struts, including a first row of struts at the first end of the frame, a second row of struts disposed adjacent to the first row of struts, and a third row of struts disposed adjacent to the second row of struts, the second row of struts disposed between the first row of struts and the third row of struts. The plurality of rows of circumferentially extending pores comprises: a first row of first pores disposed at the first end and at least partially defined by the first row of struts and the second row of struts; and a second row of second pores disposed adjacent to the first row of first pores and at least partially defined by the second row of struts and the third row of struts, wherein a first width of each first pore in the first row of first pores is greater than a second width of each second pore in the second row of second pores. The second row of struts includes a plurality of free apex regions, and each free apex region connects together adjacent ends of a corresponding pair of angled struts in the second row of struts, and has a first surface facing the first end of the frame and an opposite second surface facing the second end of the frame, wherein the first surface has a constant convex curvature extending between the adjacent ends of the corresponding pair of angled struts.

[0020] In some examples, a prosthetic heart valve comprises a radially expandable and radially compressible annular frame comprising a plurality of interconnected struts defining a plurality of rows of circumferentially extending pores disposed between an inflow end and an outflow end of the frame. The plurality of interconnected struts comprises a row of circumferentially extending outflow struts defining the outflow end, wherein each outflow strut comprises two angled strut portions interconnected by an apex region, wherein each apex region bends between a corresponding pair of the two angled strut portions and has a narrowed width and a length extending along at least 25% of the total length of the outflow strut, wherein the narrowed width is less than a width of the two angled strut portions. The plurality of interconnected struts further include a row of circumferentially extending angled first struts disposed upstream of the row of outflow struts, wherein the row of outflow struts and the row of angled first struts at least partially form a first row of pores among the plurality of circumferentially extending rows of pores disposed at the outflow end, and wherein a first width of each pore in the first row of pores is greater than a second width of pores in remaining rows of pores among the plurality of circumferentially extending rows of pores.

[0021] In some examples, a prosthetic heart valve comprises a radially expandable and radially compressible annular frame comprising a plurality of interconnected angled struts defining a plurality of rows of circumferentially extending pores 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 rows of circumferentially extending struts, including a first row of struts at the first end of the frame, a second row of struts disposed adjacent to the first row of struts, and a third row of struts disposed adjacent to the second row of struts, the second row of struts disposed between the first row of struts and the third row of struts. The plurality of rows of circumferentially extending pores comprises: a first row of first pores disposed at the first end and at least partially defined by the first row of struts and the second row of struts; and a second row of second pores disposed adjacent to the first row of first pores and at least partially defined by the second row of struts and the third row of struts, wherein a first width of each first pore in the first row of first pores is greater than a second width of each second pore in the second row of second pores. The second row of struts includes a plurality of free vertices, and each free vertex connects together adjacent ends of a corresponding 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, wherein a first edge portion of the inner skirt is secured to the second row of struts, wherein at each free vertex, the first edge portion is disposed away from the free vertex toward the second end of the frame, and wherein a second edge portion of the inner skirt is disposed at the second end of the frame.

[0022] In some examples, a prosthetic heart valve comprises a radially expandable and radially compressible annular frame comprising a plurality of interconnected angled struts, the plurality of interconnected angled struts being arranged to form a plurality of rows of circumferentially extending struts, 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 comprises an inflow edge and an outflow edge, wherein the outflow edge is sutured to the struts in the second row of struts, and comprises a plurality of peaks spaced apart from each other in a circumferential direction, wherein the peaks are aligned with corresponding vertices of the second row of struts, and wherein at least one peak has a straight edge spaced apart from the corresponding vertex toward an inflow end of the frame.

[0023] In some examples, a prosthetic heart valve comprises a radially expandable and radially compressible annular frame, the radially expandable and radially compressible annular frame comprising a plurality of interconnected angled struts, the plurality of interconnected angled struts defining a plurality of rows of circumferentially extending pores 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 rows of circumferentially extending struts, 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, and a third row of struts upstream of the second row of struts. The plurality of rows of circumferentially extending pores comprises: a first row of first pores disposed at the outflow end and at least partially defined by the first row of struts and the second row of struts and axially extending struts interconnecting struts in the first row of struts and the second row of struts; and a second row of second pores disposed upstream of the first row of first pores and at least partially defined by the second row of struts and the third row of struts. The second row of struts includes a plurality of free apex regions that are not connected to struts in the first row of struts by axially extending struts, and wherein each free apex region connects together adjacent ends of a corresponding pair of angled struts in the second row of struts, and has a first surface facing a downstream direction, an opposite second surface facing an upstream direction, and a width measured from the first surface to the second surface, wherein the width is less than the width of the struts connected by the free apex regions.

[0024] In some examples, a prosthetic heart valve includes one or more of the components described in Examples 1-38, 55-124, and 126 below.

[0025] The assembly may include a delivery device and an implantable prosthetic heart valve that is radially collapsible into a collapsed configuration and radially expandable into an expanded configuration.

[0026] In some examples, the delivery device includes a balloon, and the collapsed prosthetic heart valve can be mounted around the balloon and radially expanded to an expanded configuration of the balloon inside the patient's body.

[0027] In some instances, the prosthetic heart valve includes a radially expandable and radially compressible annular frame including a plurality of interconnected angled struts defining a plurality of rows of circumferentially extending pores arranged between an outflow end and an inflow end of the frame.

[0028] In some examples, the plurality of interconnected angled struts are arranged to form a plurality of rows of circumferentially extending struts, 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, and a third row of struts upstream of the second row of struts. The plurality of rows of circumferentially extending cells include: a first row of first cells disposed at the outflow end and at least partially defined by the first row of struts and the second row of struts; and a second row of second cells disposed upstream of the first row of first cells and at least partially defined by the second row of struts and the third row of struts, wherein a first width of each first cell in the first row of first cells is greater than a second width of each second cell in the second row of second cells.

[0029] In some examples, the second row of struts includes a plurality of free apex regions, and each free apex region connects together a corresponding pair of angled struts in the second row of struts.

[0030] In some examples, each apex region has a first surface facing the outflow end of the frame and an opposing second surface facing the inflow end of the frame.

[0031] In some instances, the first surface forms a single continuous convex curve from one of the corresponding pair of angled struts on a first side of the free apex region to the other of the corresponding pair of angled struts on an opposite second side of the free apex region.

[0032] In some examples, the prosthetic heart valve can include an inner skirt disposed around an inner surface of the frame, wherein an outflow edge portion of the inner skirt is secured to the second row of struts, and wherein at each free apex region, the outflow edge portion is disposed upstream of the free apex region.

[0033] In some examples, an assembly includes: a delivery device including a balloon; and an implantable prosthetic heart valve that is radially collapsible into a collapsed configuration and radially expandable into an expanded configuration. The prosthetic heart valve includes a radially expandable and radially compressible annular frame, the radially expandable and radially compressible annular frame including a plurality of interconnected angled struts defining a plurality of rows of circumferentially extending pores arranged 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 rows of circumferentially extending struts, 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, and a third row of struts upstream of the second row of struts. The plurality of rows of circumferentially extending pores include: a first row of first pores, the first row of first pores being disposed at the outflow end and being at least partially defined by the first row of struts and the second row of struts; and a second row of second pores, the second row of second pores being disposed upstream of the first row of first pores and being at least partially defined by the second row of struts and the third row of struts, wherein a first width of each first pore in the first row of first pores is greater than a second width of each second pore in the second row of second pores. The second row of struts includes a plurality of free apex regions, and each free apex region connects a corresponding pair of angled struts in the second row of struts together and has a first surface facing the outflow end of the frame and an opposite second surface facing the inflow end of the frame. The first surface forms a single continuous convex curve from one of the corresponding pair of angled struts on a first side of the free apex region to the other of the corresponding pair of angled struts on an opposite second side of the free apex region. The collapsed prosthetic heart valve can be mounted around the balloon and radially expanded to an expanded configuration of the balloon inside the patient's body.

[0034] In some examples, the assembly includes one or more of the components described in Examples 39-54 below.

[0035] The various innovations of the present disclosure may be used in combination or alone. The present disclosure is provided to introduce a series of concepts further described in the following specific embodiments in a simplified form. The present disclosure is not intended to identify the key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features and advantages of the present disclosure will become more apparent from the following specific embodiments, claims and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1 is a side view of a prosthetic heart valve according to one embodiment.

[0037] Figure 2 yes Figure 1 Side view of the frame of a prosthetic heart valve.

[0038] Figure 3 yes Figure 2 A side view of a portion of a frame showing the portion of the frame in a straightened (non-circular) state.

[0039] Figure 4 is a side view of an exemplary delivery device configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site.

[0040] Figure 5A is a side view of a portion of an exemplary frame for a prosthetic heart valve in a radially expanded configuration, the frame comprising a first row of pores that are wider than pores in an adjacent second row of pores, resulting in a portion of the pores in the second row of pores having a curved apex region that is not attached to struts forming the first row of pores.

[0041] Figure 5B yes Figure 5A A side view of a portion of a frame in a radially compressed configuration.

[0042] Figure 6 In a straightened (non-circular) state Figure 5A Side view of the complete frame.

[0043] Figure 7 is a side view of a portion of another exemplary frame of a prosthetic heart valve wherein angled struts of the frame assume an inwardly bent orientation in a radially compressed state of the frame.

[0044] Figure 8 is a side view of a portion of another exemplary frame of a prosthetic heart valve wherein angled struts of the frame assume a relatively straight vertical orientation in a radially compressed state of the frame.

[0045] Fig. 9 yes Figure 5A An inside view of a portion of a frame in which an inner skirt is disposed on an inner surface of a support post, the inner skirt having an outflow edge disposed below an apex region of the support post that is not attached to the support post forming a first row of aperture chambers.

[0046] Fig.10 yes Fig. 9 A cross-sectional view of a frame and an inner skirt, wherein the outer skirt is placed on the outer surface of the frame and the outflow edge of the inner skirt is folded over itself and arranged upstream of the free apex area of ​​the frame. DETAILED DESCRIPTION

[0047] General considerations

[0048] For the purposes of this specification, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and sub-combinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed examples require the presence of any one or more specific advantages or solutions to problems.

[0049] Although the operations of some of the disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this manner of description encompasses repetitions unless the specific language set forth below requires a particular order. For example, in some cases, the operations described in sequence may be repeated or performed simultaneously. In addition, for the sake of simplicity, the accompanying drawings may not show the various ways in which the disclosed methods may be used in conjunction with other methods. Additionally, this specification sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are readily discernible by a person of ordinary skill in the art.

[0050] 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 "include" means "comprise." Further, the term "coupled" generally means physical, mechanical, chemical, magnetic, and / or electrical coupling or connection, and does not exclude the presence of intervening elements between coupled or associated items absent specific language to the contrary.

[0051] As used herein, the term "proximal" refers to a device that is closer to a user and further away from a location, direction or part of an implant site. As used herein, the term "distal" refers to a device that is further away from a user and closer to a location, direction or part of an implant site. Thus, for example, the proximal motion of a device is a motion of the device away from an implant site and toward a user (e.g., leaving a patient's body), while the distal motion of a device is a motion of the device away from a user and toward an implant site (e.g., entering a patient's body). Unless otherwise clearly defined, the terms "longitudinal" and "axial" refer to axes extending in proximal and distal directions.

[0052] As used herein, "such as" means "for example," and "ie" means "that is to say."

[0053] Overview of Public Technology

[0054] As described above, the prosthetic heart valve can include a radially expandable and radially compressible annular frame and a plurality of leaflets attached to the frame. The frame can include multiple rows of pores formed by interconnected struts of the frame. The multiple rows of pores can include a first row of pores arranged at the outflow end of the frame. In some examples, the pores in the first row of pores are elongated in the axial direction relative to the pores in the remaining rows of pores of the frame.

[0055] Additionally or alternatively, in some instances, to further increase the size of the pores in the first row of pores to increase coronary access after implantation, the pores in the first row of pores can be wider in the circumferential direction relative to the pores in the remaining rows of pores of the frame. For example, in some cases, there may be one pore in the first row of pores for every two pores in each of the remaining rows of pores (e.g., because the pores in the first row are twice as wide as the pores in the remaining rows of pores). Thus, the pores in the second row of pores of the first row of pores that are positioned adjacent to and connected to the first row of pores can include free vertices that are not attached to the (additional) struts defining the first row of pores.

[0056] Since the leaflets of the prosthetic valve move between a closed state and an open state during operation of the prosthetic valve (when implanted in a patient's body), they may contact (in their open state) these free vertices of the second row of pores. In some cases, this may reduce the durability of the leaflets.

[0057] The prosthetic valve disclosed herein can be radially compressible and radially expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be curled on or held by an implant delivery device in a radially compressed state while being advanced through the patient's vascular system on the delivery device. Once the prosthetic valve reaches the implantation site, the prosthetic valve can be expanded to a radially expanded state. It should be understood that the prosthetic valve disclosed herein can be used with a variety of implant delivery devices and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0058] In some cases, when the prosthetic valve is in radial compression and the angled struts of the frame assume a more vertical orientation, the leaflets may become pinched between adjacent struts of the frame. This may also reduce the durability of the leaflets.

[0059] Various examples of frames for prosthetic heart valves are described herein, including a first row of pores disposed at a first end (e.g., an outflow end) of the frame that is wider in a circumferential direction than the pores in the remaining rows of pores of the frame, thereby creating an exposed or free vertex formed by a row of angled struts that partially define a second row of pores adjacent to the first row of pores. The free vertex can have a first surface facing the outflow end of the frame and an opposing second surface facing the inflow end of the frame, wherein the first surface has a constant convex curvature extending between adjacent ends of a pair of angled struts in the row of angled struts. In some examples, the free vertex or vertex region can have a narrowed width relative to the angled struts to which it is connected. Therefore, these free vertices or vertex regions can be more non-damaging and can not interfere with the leaflets of the prosthetic heart valve as the leaflets open and close during operation of the prosthetic heart valve. Therefore, the durability of the leaflets can be improved.

[0060] In some instances, the inner skirt can be placed around the inner surface of the frame. The outflow edge of the inner skirt can have a sawtooth shape and be fixed to a row of struts forming a free apex. However, in some instances, the outflow edge of the inner skirt can be trimmed or arranged below or upstream of the free apex. In some instances, the outflow edge can also be folded on itself (towards the frame) so that its rough edge is hidden away from the leaflet. Therefore, the durability of the leaflet can be improved.

[0061] Figure 1 An exemplary prosthetic device (e.g., a prosthetic heart valve) is shown that includes a frame, leaflets secured to an interior of the frame, and an outer skirt disposed around an outer surface of the frame. In some examples, the frame can include a plurality of interconnected and angled struts and an apex region that extends and / or curves between the angled struts at the inflow end and the outflow end of the frame, such as Figure 2 and Figure 3 In some examples, the cells in the first row of cells of the frame disposed at the first end (e.g., the outflow end) of the frame can be elongated in the axial direction relative to the cells in the remaining rows of cells of the frame ( Figure 2 and Figure 3 The prosthetic device can be delivered via a delivery device such as Figure 4 The exemplary delivery device shown) is advanced through the patient's vasculature, such as to a native heart valve.

[0062] In some examples, the cells in the first row of cells may also be wider in the circumferential direction relative to the cells in the remaining rows of cells of the frame, such as Figure 5A-6In some cases, each well in the first row of wells can span the width of two wells in the second row of wells positioned adjacent to the first row of wells, thereby creating a free apex region ( Figure 5A and 6 The free apex region may have a downstream facing surface having a constant convex curvature extending between the angled struts or strut portions to which it is connected ( Figure 5A-6 In some examples, the free apex region can have a shape similar to the apex region of the outflow end and / or inflow end of the frame (e.g., Figure 1-3 and 5A-6).

[0063] Figure 5A shows a portion of the frame in a radially expanded state, and Figure 5B The frame portion is shown in a radially compressed (or collapsed) state. In the radially compressed state, the angled struts of the frame can assume a more vertical orientation (extending in the axial direction) and be positioned closer to each other. The frame can further include relatively short horizontal struts extending between adjacent cells in the same row of cells, the relatively short horizontal struts acting as spacers and sized to maintain a minimum gap between adjacent struts in the radially compressed (crimped) state, thereby reducing the risk of leaflet pinching ( Figure 5A and 5B The frame can be configured so that the angled struts assume a relatively straight vertical orientation when compressed ( Figure 8 ) or an inward-curving shape ( Figure 7 ). When bending inward, the length of the horizontal struts can be selected to maintain a minimum gap between the struts (e.g., at their narrowest points).

[0064] Fig. 9 and 10 An inner skirt is shown mounted on the inner surface of the frame, with its outflow edge arranged upstream of the free apex region.

[0065] Examples of the disclosed technology

[0066] Figure 1A prosthetic heart valve 100 (prosthetic valve) according to one example is shown. Any of the prosthetic valves disclosed herein is suitable for implantation in a native aortic valve annulus, but in other examples, the prosthetic valve may be suitable for implantation in other native valve annuli of the heart (pulmonary valve, mitral valve, and tricuspid valve). The disclosed prosthetic valve may also be implanted in a blood vessel connected to the heart, including the patient's pulmonary artery (to replace the function of a diseased pulmonary valve, or the superior vena cava or inferior vena cava (to replace the function of a diseased tricuspid valve) or various other veins, arteries, and blood vessels. The disclosed prosthetic valve may also be implanted into a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) during a valve-in-valve procedure.

[0067] In some instances, the disclosed prosthetic valve can be implanted in a docking or anchoring device implanted in a natural heart valve or vessel. For example, in one instance, the disclosed prosthetic valve can be implanted in a docking device implanted in the pulmonary artery for replacing the function of a diseased pulmonary valve, as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another instance, the disclosed prosthetic valve can be implanted in a docking device implanted in or at a natural mitral valve, as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In another instance, the disclosed prosthetic valve can be implanted in a docking device implanted in the superior vena cava or the inferior vena cava for replacing the function of a diseased tricuspid valve, as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0068] The prosthetic heart valve 100 can include a stent or frame 102, a valve structure 104, and a paravalvular outer sealing member or outer skirt 106. The prosthetic heart valve 100 (and the frame 102) can have an inflow end 108 and an outflow end 110. The valve structure 104 can be disposed on the interior of the frame 102, while the outer skirt 106 is disposed around the outer surface of the frame 102.

[0069] The valve structure 104 may include a plurality of leaflets 112 (e.g., three leaflets, such as Figure 1), which together form a leaflet structure that can be arranged to collapse in a tricuspid arrangement. The leaflets 112 can be secured to each other at their adjacent sides (e.g., commissure tabs) to form commissures 114 of the valve structure 104. For example, each leaflet 112 can include opposing commissure tabs disposed on opposing sides of the leaflet 112 and a cusp edge portion extending between the opposing commissure tabs. The cusp edge portion of the leaflet 112 can have an undulating curved fan-like shape and can be directly secured to the frame 102 (e.g., by sutures). However, in alternative examples, the cusp edge portion of the leaflet 112 can be secured to an inner skirt, which is then secured to the frame 102. In some examples, the leaflets 112 can be formed of pericardial tissue (e.g., bovine pericardial tissue), a biocompatible synthetic material, or various other suitable natural or synthetic materials as are known in the art and described in U.S. Pat. No. 6,730,118, which is incorporated herein by reference.

[0070] In some examples, the outer skirt 106 can be an annular skirt. In some cases, the outer skirt 106 can include one or more skirt portions connected together and / or individually connected to the frame 102. The outer skirt 106 can include a fabric or polymer material such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc. In some cases, instead of Figure 1 106 may have an undulating upper edge portion extending along and secured to the angled struts 134. Examples of such outer skirts and various other outer skirts that may be used with the frame 102 may be found in U.S. Provisional Patent Application No. 63 / 366,599, filed on June 17, 2022, which is incorporated herein by reference.

[0071] The frame 102 can be in a radially compressed (or collapsed) configuration and a radially expanded configuration (the expanded configuration is Figure 1 ) between which the frame 102 can be radially compressed and radially expanded. Figure 2 1 and a portion of the frame 102 in a straightened (non-annular) configuration is shown separately in FIG. Figure 3 Shown in.

[0072] The frame 102 can be made of any of a variety of suitable plastic expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol). When composed of plastic expandable materials, the frame 102 (and therefore the valve 100) can be curled to a radially compressed state on a delivery catheter and then expanded in the patient's body by an inflatable balloon or an equivalent expansion mechanism. When composed of self-expandable materials, the frame 102 (and therefore the valve 100) can be curled to a radially compressed state and limited to a compressed state by being inserted into a sheath or an equivalent mechanism of a delivery catheter. Once in the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0073] Suitable plastic expandable materials that can be used to form the frameworks disclosed herein (e.g., framework 102) include metal alloys, polymers, or combinations thereof. Example metal alloys can include one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some instances, the framework 102 can include stainless steel. In some instances, the framework 102 can include a cobalt-chromium alloy. In some instances, the framework 102 can include nickel-cobalt-chromium. In some instances, the framework 102 includes a nickel-cobalt-chromium-molybdenum alloy, such as MP35N. TM (trade name of SPS technologies), which is equivalent to UNSR30035 (covered by ASTM F562-02). MP35N TM / UNS R30035 contains 35 wt% nickel, 35 wt% cobalt, 20 wt% chromium and 10 wt% molybdenum.

[0074] like Figure 2 and 3 As shown in FIG. 1 , the frame 102 may include a plurality of interconnected struts 116 that form a plurality of rows of open pore chambers 118 between the outflow end 110 and the inflow end 108 of the frame 102. In some examples, as shown in FIG. Figure 2 and 3 As shown, the frame 102 may include three rows of wells 118, wherein the first (in Figure 2 and 3 The first row of cells 120 (in the orientation shown above) is disposed at the outflow end 110. The first row of cells 120 includes cells 118 that are elongated in the axial direction (relative to the central longitudinal axis 122 of the frame 102) compared to the cells 118 in the remaining rows of cells. For example, the cells 118 in the first row of cells 120 may have a longer axial length 124 (124 mm) than the cells 118 in the remaining rows of cells. Figure 3), the remaining rows of pore chambers may include a second row of pore chambers 126 and a third row of pore chambers 128, the third row of pore chambers 128 being disposed at the inflow end 108, and the second row of pore chambers 126 being disposed between the first row of pore chambers 120 and the third row of pore chambers 128.

[0075] In some instances, such as Figure 2 As shown in , each row of wells includes nine wells 118. Thus, in such examples, the frame 102 can be referred to as a nine-well frame.

[0076] In alternative examples, the frame 102 may include more than three rows of cells (e.g., four or five rows) and / or more or fewer than nine cells per row. In some examples, the cells 118 in the first row of cells 120 may not be elongated compared to the cells 118 in the remaining rows of cells (the second row of cells 126 and the third row of cells 128) of the frame 102.

[0077] The interconnected struts 116 may include a plurality of angled struts 130, 132, 134, and 136 arranged in a plurality of circumferentially extending rows of angled struts 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 row of angled struts 130 arranged end-to-end and extending circumferentially at the inflow end 108 of the frame; a second row of circumferentially extending angled struts 132; a third row of circumferentially extending angled struts 134; and a fourth row of circumferentially extending angled struts 136 at the outflow end 110 of the frame 102. 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 138 (or window strut portions) and a plurality of axial (or axially extending) struts 140. Axially extending window struts 138 (which may also be referred to as axial struts including commissure windows) define commissure windows (e.g., open windows) 142 that are spaced apart from one another in a circumferential direction around the frame 102 and are adapted to receive a commissure (e.g., Figure 1 In some examples, the commissure windows 142 and / or the axially extending window struts 138 defining the commissure windows 142 may be referred to herein as commissure features or commissure supports, each of which is configured to receive and / or secure to a pair of commissure tabs in a pair of adjacent leaflets.

[0078] One or more (e.g., two, such as Figure 2 and 3Axial struts 140 (shown) can be positioned in the circumferential direction between two commissure windows 142 formed by window struts 138. Because frame 102 can include fewer pores (e.g., nine) per row and fewer axial struts 140 can be included between each commissure window 142 than some more conventional prosthetic heart valves, each pore 118 can have an increased width (in the circumferential direction), thereby providing a larger opening for blood flow and / or coronary artery access.

[0079] Each axial strut 140 and each window strut 138 extends from a position defined by the convergence of lower ends (e.g., ends disposed inboard of and furthest 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 position defined by the convergence of upper ends (e.g., 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 form axial sides of two adjacent cells in the first row of cells 120.

[0080] In some instances, such as Figure 3 As shown in FIG. 1 , each axial strut 140 may have a width 144 ( Figure 3 ), which is greater than the width of the angled struts 130, 132, 134, and 136. As used herein, the "width" of a strut is measured between relative locations on opposing surfaces of the strut that extend between the radially facing inner and outer surfaces of the strut (relative to the central longitudinal axis 122 of the frame 102). The "thickness" of the strut is measured between relative locations on the radially facing inner and outer surfaces of the strut and is perpendicular to the width of the strut. In some examples, the width 144 of the axial strut 140 is 50-200%, 75-150%, or at least 100% (e.g., twice) greater than the width of the angled struts of the frame 102.

[0081] By providing the axial struts 140 with a width 144 that is greater than the width of the other angled struts of the frame 102, a greater contact area is provided when the leaflets 112 contact the wider axial struts 140 during systole, thereby distributing stresses and reducing the extent to which the leaflets 112 may fold over the axial struts 140, radially outward through the ostium 118. As a result, the long-term durability of the leaflets 112 may be improved.

[0082] Because the pores 118 of the frame 102 can have a relatively large width compared to alternative prosthetic valves having more than nine pores per row (as described above), wider axial struts 140 can be more easily incorporated into the frame 102 without sacrificing open space for blood flow and / or coronary artery access.

[0083] The commissure tabs 115 of adjacent leaflets 112 may be secured together to form commissures 114 ( Figure 1 Each commissure 114 of the prosthetic heart valve 100 includes two commissure tabs 115 that pair together, one from each of two adjacent leaflets 112, and extend through a commissure window 142 of the frame 102. Each commissure 114 can be secured to a window post 138 that forms the commissure window 142.

[0084] The cusp 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 examples, the cusp edge portion of each leaflet 112 can be secured directly to a strut (e.g., angled struts 130, 132, and 134) of the frame 102. For example, the cusp edge portion of the leaflet 112 can be sutured to the angled struts 130, 132, and 134 that generally follow the contour of the cusp edge portion of the leaflet 112.

[0085] In some examples, the cusp edge portions of the leaflets 112 can be secured to the inner skirt, and the inner skirt can then be secured directly to the frame 102 .

[0086] Various methods for securing leaflets 112 to a frame such as frame 102 are disclosed in U.S. Provisional Patent Application 63 / 278,922 filed on November 12, 2021 and U.S. Provisional Patent Application 63 / 300,302 filed on January 18, 2022, both of which are incorporated herein by reference.

[0087] like Figure 2 and Figure 3 As shown in , in some examples, one or more or each of the axial struts 140 can include an inflow end portion 146 (e.g., the end portion closest to the inflow end 108) and an outflow end portion 148 that are widened relative to a middle portion 150 (which can be defined by a width 144) of the axial strut 140. In some cases, the inflow end portion 146 of the axial strut 140 can include an orifice 147. The orifice 147 can be configured to receive a fastener (e.g., a suture) to attach the soft component of the prosthetic heart valve 100 to the frame 102. For example, in some cases, as Figure 1 As shown in FIG. 1 , the outer skirt 106 can be positioned around the outer surface of the frame 102 , and the upper or outflow edge portion of the outer skirt 106 can be secured to the aperture 147 by fasteners 149 (eg, sutures).

[0088] The interconnected struts 116 may also include horizontal struts 182 extending between adjacent cells 118 in a cell of the frame 102 ( Figure 2 and 3 ). The horizontal struts 182 can extend in a circumferential direction and are also referred to as circumferentially extending struts 182. The horizontal struts 182 can connect the angled struts in two adjacent rows of angled struts of the frame 102 to each other. For example, each horizontal strut 182 can connect to two angled struts in a row of struts (e.g., Figure 3 The support 134 shown) and two angled supports in another row of adjacent supports (e.g., Figure 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 angled lines that can follow the fanning lines of the leaflets when the leaflets are attached to the frame 102. Thus, when the frame 102 is in a radially expanded configuration (e.g., Figure 2 and 3 ), the horizontal struts 182 can allow the angled struts to follow a shape that more closely matches the shape of the fan line of the leaflets. Additionally, the horizontal struts 182 can serve as spacers that can maintain a specified gap between the angled struts when the frame 102 is in the radially compressed configuration, thereby reducing the risk of pinching the leaflets between the struts in the radially compressed configuration.

[0089] The frame 102 may further include a plurality of apex regions 152 formed at the inflow end 108 and the outflow end 110, each apex region 152 extending and forming a junction between two angled struts 130 at the inflow end 108 or a junction between two angled struts 136 at the outflow end 110. Thus, the apex regions 152 are spaced apart from each other in the circumferential direction at the inflow end 108 and the outflow end 110.

[0090] Each apex region 152 may include an apex 154 (the point that is highest or extends most outward in the axial direction) and two thinned (or narrowed) strut portions 156, one thinned strut portion 156 extending from either side of the apex 154 to a corresponding wider angled strut 136 (at the outflow end 110) or angled strut 130 (at the inflow end 108) ( Figure 3). In this way, each of the apex regions 152 at the outflow end 110 can form a narrowed transition region between and relative to two angled struts 136 extending from the corresponding apex region 152, and each of the apex regions 152 at the inflow end 108 can form a narrowed transition region between and relative to two angled struts 130 extending from the corresponding apex region 152.

[0091] The thinned strut portion 156 of the apex region 152 may have a width 158 (160) that is less than the width 160 of the angled struts 130 or 136. Figure 3 ). In some examples, width 158 can be a uniform width (e.g., along the entire length of strut portion 156). In some examples, width 158 of thinned strut portion 156 can be approximately 0.06-0.15 mm less than width 160 of angled struts 130 and / or 136.

[0092] The thinned strut portion 156 of the apex region 152 may have a first length 162 ( Figure 3 ). In some examples, the first length 162 is in the range of 0.8-1.4 mm, 0.9-1.2 mm, 0.95-1.05 mm, or about 1.0 mm (e.g., ± 0.03 mm). In alternative examples, the first length 162 is in the range of 0.3-0.7 mm, 0.4-0.6 mm, 0.45-0.55 mm, or about 0.5 mm (e.g., ± 0.03 mm).

[0093] Thus, each outflow apex region 152 may include two thinned strut portions 156 having a first length 162, each extending outwardly 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.

[0094] Each apex region 152 and two corresponding angled struts 136 at the outflow end 110 may form an outflow strut 166 , and each apex region 152 and two corresponding angled struts 130 at the inflow end 108 may form an inflow strut 168 .

[0095] Each outflow strut 166 and inflow strut 168 may have a length that includes the apex region 152 and two angled struts 136 or 130 (or strut portions) on either side of the apex region 152. Half of the total length of each outflow strut 166 and inflow strut 168 is within Figure 31 and 16 as a length 170 extending 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 inflow strut 168 is twice the length 170. In some examples, the length 170 of one half of each inflow strut 168 may be different than the length 170 of one half of each outflow strut 166.

[0096] In some cases, the length of each thinned strut portion 156 can be at least 25% of the length 170 of the corresponding half of the outflow strut 166 or the inflow strut 168. In other words, the length of each apex region 152 (the 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 the inflow strut 168. In some examples, the length of each apex region 152 can be greater than 25%, such as 25-35%, of the total length of the corresponding outflow strut 166 or the inflow strut 168.

[0097] In some examples, each apex region 152 can include a curved axially facing outer surface 172 and an arcuate or curved axially facing inner recess 174 forming a thinned strut portion 156. For example, the curved inner recess 174 can be recessed from the inner surface of the angled strut portion 156 toward the curved outer surface 172, thereby forming a smaller width thinned strut portion 156. Thus, the curved inner recess 174 can be formed on the cell side of the apex region 152 (e.g., opposite the exterior of the apex region 152).

[0098] In some instances, 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).

[0099] As used herein, "constant convex curvature" may refer to a continuously curved surface that is convex and has no inflection points (no change in direction of curvature).

[0100] Each vertex region 152 can have a radius of curvature 176 along the curved outer surface 172 (e.g., in some cases, along the entirety or entire length of the curved outer surface 172) ( Figure 3). In some cases, the radius of curvature 176 of the entire curved outer surface 172 at the vertex 154 and / or along the vertex region 152 can be greater than 1 mm. In some cases, the radius of curvature 176 can be in the range of 1-20 mm, 3-16 mm, or 8-14 mm. In some cases, the radius of curvature 176 can be greater than 10 mm. The radius of curvature 176 can depend on the width 158 of the thinned pillar portion 156 (e.g., the amount of reduction from the width of the angled pillar 130 or 136) and the first length 162 (and therefore change due to changes in the width and the first length).

[0101] Additionally, the height (axial height) 178 of the apex region 152 may be the width 158 ( Figure 3 ), the height can be defined in the axial direction from the outer surface of the two angled struts 130 or 136 to the curved outer surface 172 of the apex region 152 at the apex 414. In this way, the height 178 of the apex region 152 can be relatively small and does not add to the overall axial height of the radially expanded frame 102. Figure 1 )'s leaflets 112 may be positioned proximate 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 .

[0102] In some examples, each of the apex regions 152 may form an angle 180 (°C) between two angled struts 130 or 136 extending from either side of the corresponding apex region 152. Figure 3 ). In some cases, angle 180 can be in the range of 120 (exclusive) to 140 degrees (eg, such that angle 180 is greater than 120 degrees and less than or equal to 140 degrees).

[0103] Additional details and examples of frames for prosthetic heart valves including apex regions can be found in PCT Application No. PCT / US2022 / 025687, which is incorporated herein by reference.

[0104] Figure 4 A delivery device 200 is shown according to one example that can be used to implant an expandable prosthetic heart valve (eg, Figure 1 In some examples, delivery device 200 is particularly suitable for introducing a prosthetic valve into a heart.

[0105] Figure 4The delivery device 200 in the illustrated example is a balloon catheter that includes 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 from the handle 202 and extending distally from the handle 202, the portion extending distally from the handle 202 also coaxially extending through the outer shaft 204. Additionally, the delivery device 200 may further include an inner shaft 208 that extends distally from the handle 202 coaxially through the intermediate shaft 206 and the outer shaft 204, and extends proximally from the handle 202 coaxially through the intermediate shaft 206.

[0106] Outer shaft 204 and intermediate shaft 206 may be configured to longitudinally translate (eg, move) relative to one another along central longitudinal axis 220 of delivery device 200 to facilitate delivery and positioning of a prosthetic valve at an implantation site within a patient.

[0107] The intermediate shaft 206 may include a proximal portion 210 extending proximally from the proximal end of the handle 202 to the adapter 212. A rotatable knob 214 may be mounted on the proximal portion 210 and may be configured to rotate the intermediate shaft 206 about the central longitudinal axis 220 and relative to the outer shaft 204.

[0108] The adapter 212 can include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive a fluid (eg, an inflation fluid) from a fluid source. The second port 240 can be fluidly coupled to the inner lumen of the intermediate shaft 206.

[0109] The intermediate shaft 206 can further include a distal 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 expandable balloon 218 of the delivery device 200. The distal portion of the inner shaft 208 can extend distally beyond the distal portion of the intermediate shaft 206.

[0110] The balloon 218 can be coupled to the distal portion of the intermediate shaft 206 .

[0111] In some examples, the distal end of balloon 218 can be coupled to the distal end of delivery device 200, such as to nose cone 222 (eg, Figure 4 200), or an alternative component (e.g., a distal shoulder) coupled to the distal end of the delivery device 200. The middle portion of the balloon 218 can cover the valve mounting portion 224 of the distal portion of the delivery device 200, and the distal portion of the balloon 218 can cover the distal shoulder 226 of the delivery device 200. The valve mounting portion 224 and the middle portion of the balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as Figure 4As schematically shown in , a prosthetic heart valve 250 , which may be one of the prosthetic valves described herein, may be mounted around a balloon 218 at a valve mounting portion 224 of a delivery device 200 .

[0112] 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.

[0113] The outer shaft 204 may include a distal tip portion 228 mounted on its distal end. Figure 4 224) and during delivery of the prosthetic valve to the target implantation site, the outer shaft 204 and the intermediate shaft 206 can be axially translated relative to each other to position the distal tip portion 228 adjacent to the proximal end of the valve mounting portion 224. Thus, the distal tip portion 228 can be configured to resist proximal movement of the prosthetic valve 250 relative to the balloon 218 in an axial direction relative to the balloon 218 when the distal tip portion 228 is disposed adjacent to the proximal side of the valve mounting portion 224.

[0114] An annular space can be defined between the outer surface of the inner shaft 208 and the inner surface of the intermediate shaft 206, and can be configured to receive fluid from a fluid source via the second port 240 of the adapter 212. The annular space can be fluidly coupled to a fluid passage formed between the outer surface of the distal portion of the inner shaft 208 and the inner surface of the balloon 218. Thus, fluid from the fluid source can flow from the annular space to the fluid passage to inflate the balloon 218 and radially expand and deploy the prosthetic valve 250.

[0115] The inner lumen of the inner shaft can be configured to receive a guidewire therethrough for guiding the distal portion of the delivery device 200 to the target implantation site.

[0116] The handle 202 may include a steering mechanism configured to adjust the curvature of the distal portion of the delivery device 200. In the illustrated example, for example, the handle 202 includes an adjustment member, such as a rotatable knob 260 as illustrated, which is in turn operatively coupled to the proximal portion of the traction wire. The traction wire may extend distally from the handle 202 through the outer shaft 204 and have a distal portion fixed to the outer shaft 204 at or near the distal end of the outer shaft 204. Rotating the knob 260 may increase or decrease the tension in the traction wire, thereby adjusting the curvature of the distal portion of the delivery device 200. Further details on the steering or flexing mechanism for the delivery device may be found in U.S. Pat. No. 9,339,384, which is incorporated herein by reference.

[0117] The handle 202 can further include an adjustment mechanism 261 and an associated locking mechanism, the adjustment mechanism including an adjustment member, such as a rotatable knob 262 as shown, the locking mechanism including another adjustment member configured as a rotatable knob 278. The adjustment mechanism 261 is configured to adjust the axial position of the intermediate shaft 206 relative to the outer shaft 204 (e.g., for fine positioning at the implantation site). Additional details about the delivery device 200 can be found in PCT Application No. PCT / US2021 / 047056, which is incorporated herein by reference.

[0118] Figure 5A-6 Another exemplary frame 300 for a prosthetic heart valve is shown. In some examples, the frame 300 may be used in place of Figure 1 The frame 102 of the prosthetic heart valve 100 of FIG. 300 can be in a radially compressed (or collapsed) configuration ( Figure 5B ) and radial expansion configurations ( Figure 5A ) can be radially compressed and radially expanded. A portion of the frame 300 is Figure 5A and 5B , while the entire frame 300 in a straightened (non-annular) configuration is shown in Figure 8 It should be noted that the frame 300 can be in an annular configuration, such as Figure 2 shown.

[0119] Frame 300 may comprise a plastically expandable material (eg, stainless steel, etc.) or a self-expanding material (eg, nickel-titanium alloy (NiTi), such as Nitinol) as discussed above with reference to frame 102 .

[0120] The frame 300 may include a plurality of interconnected struts 316 that form a plurality of rows of open pore chambers 314, 318 between the outflow end 302 and the inflow end 304 of the frame 300. In some examples, as Figure 5A-6 As shown, the frame 300 may include four rows of wells 314, 318, wherein the first (in Figure 5A-6 The first row of cells 320 is disposed at the outflow end 302 (in the orientation shown). The first row of cells 320 includes cells 314 that are elongated in the axial direction (relative to the central longitudinal axis of the frame 300 and the direction extending between the outflow end 302 and the inflow end 304) and wider in the circumferential direction than the cells 318 in the remaining rows of cells. For example, the cells 314 in the first row of cells 320 may have a longer axial length 324 ( 100 ft ) than the cells 318 in the remaining rows of cells. Figure 5A , as measured from the outflow end to the inflow end of the cell 320) and a greater width 322. The increased width 322 and axial length 324 of the first row of cells 314 can provide a larger opening for coronary artery access through the frame 300.

[0121] The remaining rows of cells may include second row of cells 326, third row of cells 328, and fourth row of cells 329. Fourth row of cells 329 is disposed at inflow end 304, and second row of cells 326 is disposed between first row of cells 320 and third row of cells 328 (which is disposed adjacent to fourth row of cells 329).

[0122] In some instances, such as Figure 6 As shown, each of the second row of wells 326, the third row of wells 328, and the fourth row of wells 329 includes 12 wells 318, and the first row of wells 320 includes six wells 314. This arrangement of the different number of wells between the first row of wells 320 and the remaining rows of wells is due to the fact that the width 322 of the wells 314 in the first row of wells 320 is twice the width 312 of the wells 318 in the remaining rows of wells (e.g., the adjacent second row of wells 326). Therefore, in some examples, each well 314 in the first row of wells 320 can span the width of two wells 314 (such as the third row of wells 328, such as the fourth row of wells 329). Figure 5A and 6 In other words, the width 322 of each cell 314 may be twice the width 312 of the cell 318.

[0123] In alternative examples, frame 300 may include a different number of rows of wells, such as three rows (e.g., similar to Figure 2 and 3 Additionally or alternatively, in some cases, frame 300 may include more or less than 12 and six cells per row (e.g., ten and five cells per row). In some alternative examples, cells 314 in first row 320 of cells may not be elongated compared to cells 318 in the remaining rows of cells of frame 300. In still other alternative examples, width 322 of cells 314 may be greater than or less than Figure 5A and 6 The width shown (eg, 1.5 times the width 312 of the cavity 318).

[0124] The interconnected struts 316 may include a plurality of angled struts 330, 331, 332, 334, and 336 arranged in a plurality of circumferentially extending rows of angled struts 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 row of angled struts 330 arranged end to end and extending circumferentially at the inflow end 304 of the frame; a second row of circumferentially extending angled struts 331; a third row of circumferentially extending angled struts 332; a fourth row of circumferentially extending angled struts 334; and a fifth row of circumferentially extending angled struts 336 at the outflow end 302 of the frame 300. The circumferentially extending rows of angled struts (and additional components, such as rows of cells) may be referred to herein as "upstream" or "downstream" of other circumferentially extending rows of angled struts. As used herein, "upstream" or "downstream" is relative to the outflow end 302 of the frame (which is the downstream end of the frame) and the inflow end 304 of the frame (which is the upstream end of the frame) and the direction of blood flow through the frame 300 (from the inflow end 304 to the outflow end 302). For example, the fourth row of angled struts 334 is positioned upstream of the fifth row of angled struts 336.

[0125] The fifth row of angled struts 336 can be connected to the fourth row of angled struts 334 via a plurality of axially extending window struts 338 (which can be configured similarly to the window struts 138 of the frame 102, as described above) and a plurality of axial (or axially extending) struts 340 (which can be configured similarly to the axial struts 140 of the frame 102, as described above). The axially extending window struts 338 (which can also be referred to as axial struts including commissure windows) define commissure windows (e.g., open windows) 342 that are spaced apart from each other in a circumferential direction around the frame 300 and are adapted to receive a plurality of axially extending window struts 338 disposed to the commissures (e.g., open windows). Figure 1 In some examples, the commissure windows 342 and / or the axially extending window struts 338 defining the commissure windows 342 may be referred to herein as commissure features or commissure supports, each of which is configured to receive and / or secure to a pair of commissure tabs in a pair of adjacent leaflets.

[0126] like Figure 6As shown, one axial strut 340 can be positioned in the circumferential direction between two commissure windows 342 formed by the window strut portion 338. Each axial strut 340 and each window strut 338 extend from a position defined by the convergence of lower ends (e.g., ends disposed inside and farthest 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 position defined by the convergence of upper ends (e.g., ends disposed 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 form axial sides of two adjacent cells in the first row of cells 320.

[0127] In some examples, the width 360 of angled strut 336 can be greater than the width of the struts in the remaining rows of struts (e.g., to provide increased strength for larger / wider cells 314). For example, width 360 can be greater than width 362 of angled strut 334 (which can also be the width of angled struts 331 and 332 in some examples). Additionally, in some examples, width 364 of angled strut 330 can be greater than width 362. However, in some examples, width 360 of angled strut 336 can still be greater than width 364 of angled strut 330.

[0128] In some examples, the frame 300 can further include a plurality of apex regions 352 formed at the outflow end 302 and a plurality of apex regions 354 formed at the inflow end 304. Each apex region 354 can extend at the inflow end 304 of the frame 300 and form a junction between two angled struts 330. The apex regions 354 can be configured the same or similar to the apex regions 152, as described above (and therefore, not re-described here for the sake of brevity).

[0129] 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 region 352 can also be configured similarly to the apex region 152, as described above. For example, each apex region 352 can include an apex 355 and two thinned (or narrowed) strut portions 356 ( Figure 5A ), the strut portions 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 may have a width 357 ( Figure 5A ).

[0130] In some examples, width 357 can be approximately 0.06-0.15 mm less than width 360 of angled struts 336. For example, in some cases, width 360 can be approximately 0.46 mm and width 357 can be approximately 0.4 mm.

[0131] However, because cell 314 is wider than the cells in the remaining rows of frame 300 (and compared to cell 118 in frame 102), the length of angled struts 336 is greater than the length of angled struts 330. Thus, for example, the length of thinned strut portion 356 of each vertex region 352 may be longer than the length of thinned strut portion 358 of each vertex region 354 ( Figure 5A ). However, the relative proportions between the thinned strut portions 356 and the angled struts 336 of the apex region 352 can be similar or identical to the relative proportions of the apex region 152 of the frame 102 described above (e.g., the length of the thinned strut portions 356 can be at least 25% of the length of the angled struts 336).

[0132] Each vertex region 352 and two corresponding angled struts 336 at the outflow end 302 may form an outflow strut 366, and each vertex region 354 and two corresponding angled struts 330 at the inflow end 304 may form an inflow strut 368. Due to the increased width 322 of the cells 314 in the first row of cells 320, the outflow struts 366 are longer than the inflow struts 368.

[0133] The length of the vertex region 352 (e.g., the length of the arc along the two thinned pillar portions 356, similar to Figure 3 The length 162 shown is at least 25% of the length of the outflow strut 366. Similarly, the length of the apex region 354 is at least 25% of the length of the inflow strut 368.

[0134] As described above, the overall shape or curvature of apex regions 352 and 354 may be similar to the shape or curvature of apex region 152. Exemplary dimensions of apex regions 352 and 354 are described below with reference to free apex region 370.

[0135] In this way, the apex region 352 can have a relatively small axial height and not add much to the overall axial height of the radially expanded frame 300 (similar to the apex region 152 as described above, and despite the longer length of the outflow struts 366). Thus, the axial height of the radially expanded frame 300 can be less than alternative valve frames having a more pointed apex and / or having a greater axial height.

[0136] Due to the increased width 322 of the cells 314 in the first row of cells 320 relative to the width 312 of the cells 318 in the second row of cells 326, a portion of the second row of cells 320 may be formed by struts having exposed or free apex regions 370 that are not attached to another strut of an adjacent row of cells (the first row of cells 320). As used herein, a "free apex region" may refer to an apex region that is not attached (directly attached) to any other strut, except for an angled strut that bends and extends therebetween (e.g., a pair of angled struts 334 and a corresponding apex region 370 disposed therebetween).

[0137] For example, the free apex region 370 is not attached to any axial struts 340 or axially extending window struts 338. Figure 5A-6 As shown, every other cell 318 in the second row of cells 326 can be defined by a strut having a free apex region 370. In an alternative example, more than one cell 318 defined by a strut having a free apex region 370 can 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.

[0138] As described above, in some instances, the free apex region 370 can interact with the leaflets of a prosthetic heart valve. Figure 1 When the leaflets 112 of the prosthetic heart valve are secured to the frame 300 as described herein, the free apex region 370 can be positioned at the level (or axial height) of a portion of the leaflets that open and close during operation of the prosthetic heart valve. Thus, in some cases, the leaflets can contact the free apex region 370 when the leaflets are in an open state when implanted in a patient.

[0139] Therefore, it is beneficial for the free apex region 370 to have a curved outer surface 372 similar to the apex regions 352 and 354. For example, Figure 5A-6 As shown, each free apex region 370 can have an overall shape similar to apex regions 352 and 354, as described above, such as having a continuously curved outer surface 372 having a constant convex curvature that curves between the angled struts 334 to which it is connected (e.g., having a radius of curvature within any of the ranges described herein for any of the curved apex regions). The outer surface 372 can face in a downstream direction or toward the outflow end 302.

[0140] As used herein, "constant convex curvature" may refer to a continuously curved surface that is convex and has no inflection points (no change in direction of curvature).

[0141] Each free apex region 370 can extend and 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 corresponding wider angled struts 334 (similar to apex regions 352, 354, and / or 152). As described above, the overall shape or curvature of free apex region 370 can be similar to the overall shape or curvature of apex region 152.

[0142] The free apex regions 370 (e.g., the thinned strut portions and the apex in the free apex regions 370) have a narrowed width relative to the angled struts 334 to which they are connected, thereby forming an inner recess 374 on the bore side of each free apex region 370 (e.g., the inner recess 374 is formed on the opposing inner surface 373 of the free apex region 370 facing in the upstream direction or toward the inflow end 304). The width of the free apex region 370 can be defined between the outer surface 372 and the inner surface 373.

[0143] The width of the free apex region 370 may be approximately 0.06-0.15 mm less than the width of the angled struts 334. For example, in some cases, the width of the free apex region 370 may be approximately 0.18 mm, and the width of the angled struts 334 may be approximately 0.24 mm.

[0144] The length of each free vertex region 370 (eg, along the vertex region 370, similar to Figure 3 The arc length (arc length) of length 162 shown is at least 25% of the length of the entire strut to which it belongs, where the strut is defined as including the free apex region 370 and the two angled struts 335 connected thereto.

[0145] In some cases, the lengths of free apex zone 370, outflow apex zone 352, and / or inflow apex zone 354 may be in the range of 0.5-4.7 mm or 0.9-3.7 mm (e.g., free apex zone 370 at the lower end of the range and outflow apex zone 352 at the upper end of the range).

[0146] In some examples, the radius of curvature of the free apex region 370 , the outflow apex region 352 , and / or the inflow apex region 354 may be in the range of 0.3-10 mm, 0.5-8 mm, or 0.2-20 mm.

[0147] In some cases, the ratio between the width of any of apex regions 370, 352, and 354 to the width of the angled strut to which it is connected (e.g., the ratio between the width of free apex region 370 and the width of angled strut 334 and / or the ratio between width 357 and width 360 of apex region 352) can be in the range of 0.15–0.98, 0.4–0.8, or 0.6–0.9.

[0148] In some examples, the central longitudinal axis of each free apex region 370 may be aligned with (overlapping with) the central longitudinal axis of the corresponding apex region 352. In alternative examples, the free apex regions 370 may not be aligned with the corresponding apex regions 352 (e.g., if the cells 314 are not twice as wide as the cells 318 in the second row of cells 326).

[0149] In this way, the free apex region 370 can have a more curved (less angled) outer surface that is more atraumatic and does not interfere with the leaflets of the prosthetic heart valve as the leaflets open and close during operation of the prosthetic heart valve. Thus, the long-term durability of the prosthetic valve leaflets can be improved.

[0150] In an alternative example, the free apex region 370 of the frame 300 may not include a curved outer surface 372 having a constant convex curvature. Instead, the free apex region 370 may have an alternative shape similar to the junction between two angled struts 334 connected to the axial struts 340 or the axially extending window struts 338.

[0151] like Figure 5A-6 As shown, the interconnected struts 316 of the frame 300 may also include horizontal struts 382 (which may be similar to the horizontal struts 182 of the frame 102, as described above) extending between adjacent pores 318 in a row of pores of the frame 300. The horizontal struts 382 may connect the angled struts in two adjacent rows of angled struts of the frame 300 to each other. As described above with reference to the horizontal struts 182 of the frame 102, when the frame 300 is in the radially expanded configuration, the horizontal struts 382 may allow the angled struts 330, 331, 332, and 334 to follow a shape that closely matches the shape of the fan lines of the leaflets of the prosthetic valve ( Figure 5A ). Additionally, when the frame 300 is in the radially compressed configuration ( Figure 5B), the horizontal struts 382 can act as spacers that maintain specified gaps 384 between the angled struts 330, 331, 332, and 334, wherein the specified gaps 384 can be minimized as much as possible (to minimize the curling profile of the prosthetic valve) while still being large enough to reduce the risk of catching 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 curled).

[0152] Figure 7 and 8 Two examples of prosthetic valve frames 400 and 500 are shown, respectively, including horizontal struts 382 and angled struts 330, 331, 332, and 334 that either assume a relatively straight vertical orientation ( Figure 8 ), or present an inward curving orientation ( Figure 7 ). Figure 7 and 8 The frames 400 and 500 of can be similar to the frame 300, but without the wider outflow aperture chamber (aperture chamber 314). However, it should be noted that as described below with reference to Figure 7 and 8 The angled or straight orientations of the angled posts 330 , 331 , 332 , and 334 described may also be applied to the frame 300 .

[0153] When the angled struts 330, 331, 332, and 334 assume an inwardly bent (or angled) orientation in the compressed state of the frame 400 ( Figure 7 ), the length 404 of the horizontal struts 382 can be specified to maintain a minimum gap 402 between the angled struts, for example, measured at a minimum width value (in the circumferential direction of the frame 400) between adjacent horizontal struts 382. The minimum gap 402 can reduce the curling profile of the frame 400 while avoiding pinching of the leaflets between the angled struts in the curled state.

[0154] When the angled struts 330, 331, 332 and 334 are in the compressed state of the frame 500 ( Figure 8 ) presents a relatively straight vertical orientation (in the axial direction), the length 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 curling profile of the frame 500 while avoiding pinching of the leaflets between the angled struts in the curled state.

[0155] In some examples, the horizontal struts 382 are sized to maintain the minimum gap 402 or 502 within a range of approximately 0.2 mm-0.7 mm or approximately 0.3 mm-0.4 mm.

[0156] In other examples, the minimum gap 402 or 502 in the crimped configuration can be a function of the thickness of the prosthetic valve leaflets and can take into account the compressibility of the tissue of the leaflets. For example, for a leaflet having a thickness of about 0.2 mm, the minimum gap 402 or 502 can be designed to accommodate the leaflet folded on itself, which may require a gap of at least 0.4 mm. However, if the tissue has a compressibility of about 50%, then designing a minimum gap of about 0.2 mm may be sufficient.

[0157] In this way, the frame of a prosthetic heart valve can be configured to increase the durability and long-term endurance of the prosthetic heart valve (e.g., upon implantation) while also reducing the curl profile of the prosthetic heart valve and reducing stress on the frame struts (e.g., due to the shape of the apex region).

[0158] As introduced above, in some examples, the prosthetic valve can include an inner skirt disposed on the inner surface of a frame (any of the frames described herein or a similar frame). In some examples, the cusp edge portion of the leaflet (e.g., leaflet 112) can be secured to the inner skirt, and then the inner skirt can be directly secured to the frame.

[0159] Fig. 9 and 10 An exemplary inner skirt 600 is shown disposed on the inner surface of the frame 300. For example, Fig. 9 An interior view of the frame 300 is shown with the inner skirt 600 disposed against the inner surfaces of the angled struts 330, 331, 332, 334, and Fig.10 Shows Fig. 9 300 and inner skirt 600, wherein outer skirt 620 is disposed around the outer surface of frame 300. Although inner skirt 600 is depicted on frame 300, it should be noted that inner skirt 600 may be similarly disposed on a different prosthetic valve frame having a free apex or apex region.

[0160] The inner skirt 600 may have an inflow edge portion 602 and an outflow edge portion 604 disposed at the inflow end 304 of the frame 300. The outflow edge portion 604 may have a sawtooth shape. Fig. 9 As shown, the outflow edge portion 604 can include a plurality of peaks spaced apart from each other in the circumferential direction. The outflow edge portion 604 can also include a plurality of valleys spaced apart from each other in the circumferential direction, wherein one valley is disposed between two adjacent peaks. In some examples, the shape of the outflow edge portion 604 can follow the shape of the fourth row of angled struts 334 (or the second row of struts relative to the outflow end 302). For example, the outflow edge portion 604 can be fixed to the angled struts 334 with a plurality of sutures 606.

[0161] At each free apex region 370 (or free apex in another framework), a corresponding peak 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 the corresponding apex region 370, thereby exposing the free apex region 370 (e.g., Fig. 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 the outflow edge portion 604 (or downstream thereof).

[0162] In some examples, the peak of the outflow edge portion 604 can include a trimmed, flat, or straight edge 610 at each apex region 370. The straight edge 610 of the inner skirt 600 can be positioned upstream and away from the corresponding apex region 370. In other words, the straight edge 610 can be spaced apart from the corresponding apex region 370 toward the inflow end of the frame.

[0163] In some examples, the outflow edge portion 604 (or portions thereof) is folded outwardly, toward the frame 300, and folded upon itself (eg, Fig.10 As a result, the outflow edge 608 of the outflow edge portion 604 is disposed between (sandwiched between) the inner surface of the frame 300 and the adjacent portion of the inner skirt 600 (as shown in FIG. Fig.10 Thus, in some examples, one or more peaks of the outflow edge portion 604 may be folded to form a fold line that forms a corresponding straight edge 610.

[0164] In some examples, the peaks of the outflow edge portion 604 include a plurality of first peaks aligned with respective vertices of the angled struts 334 connected to the axially extending window struts 338 and a plurality of second peaks aligned with respective free apex regions 370. As described above, the second peaks may have straight edges 610, while the first peaks may be pointed (e.g., not trimmed or folded). Thus, in some examples, the first peaks may extend axially toward the outflow end of the frame to a greater extent than the second peaks.

[0165] In some examples, outflow edge 608 is fused or rougher than the rest of inner skirt 600. Thus, folding outflow edge portion 604 in this manner can hide outflow edge 608 away from the interior of the prosthetic valve, thereby preventing the leaflets from contacting outflow edge 608.

[0166] When the frame 300 (or another frame to which the inner skirt 600 is attached) is radially compressed (or crimped) into a radially compressed configuration, the outflow edge portion 604 of the inner skirt 600 slides upstream on the frame 300 and away from the free apex region 370. During radial expansion of the frame (e.g., to a radially expanded configuration), the outflow edge portion 604 is pulled up by the sutures 606 sliding over the angled struts 334, but not all the way to the apex region 370.

[0167] This ensures that the flat or straight edge 610 of the inner skirt 600 remains at or below (upstream of) the level of the free apex region 370, thereby reducing the likelihood that the outflow edge 608 will contact the tissue of the leaflet. In addition, by including the inner skirt 600 on a frame 300 that includes a curved apex region 370 (as described above), the durability of the leaflet can be further improved.

[0168] The inner skirt 600 can be formed in whole or in part by any suitable biomaterial, synthetic material (e.g., any polymer in a variety of polymers), or a combination thereof. In some examples, the inner skirt 600 can include a fabric with 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 pile or suede. Exemplary fabrics with plush pile or suede include velvet, velvet, velvet, corduroy, terry, fleece, etc. In some examples, the inner skirt 600 can include a fabric without interwoven yarns or fibers or randomly interwoven yarns or fibers, such as felt or electrospun fabrics. Exemplary materials that can 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, etc. In some examples, the inner skirt 600 can include a non-woven or non-fabric material, such as a film made of any of a variety of polymer materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the inner skirt 600 can include a sponge material or foam, such as polyurethane foam. In some examples, the inner skirt 600 can include natural tissue, such as pericardium (e.g., bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0169] Delivery Technology

[0170] In order to implant the prosthetic valve in the natural aortic valve via the transfemoral delivery method, the prosthetic valve is installed along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal 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 in the native aortic valve and radially expanded (e.g., by inflating the balloon, actuating one or more actuators of the delivery device, or deploying the prosthetic valve from the sheath to allow the prosthetic valve to expand itself). Alternatively, the prosthetic valve can be implanted in the natural aortic valve in a transapical surgery, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and apex, and the prosthetic valve is positioned in the natural aortic valve. Alternatively, in a transaortic approach, the prosthetic valve (on the distal portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-shaped sternotomy or a right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0171] To implant a prosthetic valve into the native mitral valve via a transseptal delivery method, the prosthetic valve is mounted along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the atrial septum (through a perforation made in the atrial septum), into the left atrium, and advanced toward the native mitral valve. Alternatively, the prosthetic valve can be implanted into the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0172] To implant the prosthetic valve into the native tricuspid valve, the prosthetic valve is mounted along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar method can be used to implant the prosthetic valve into the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0173] Another delivery method is a transatrial approach, whereby the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision in the atrial wall (right or left atrium) for access to any native heart valve. Atrial delivery can also be performed intravascularly, such as from the pulmonary veins. Yet another delivery method is a transventricular approach, whereby the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision in the right ventricle wall (usually at or near the bottom of the heart) for implantation of the prosthetic valve into the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0174] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery methods are not intended to be limited. Any prosthetic valve disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0175] Any of the systems, devices, equipment, etc. herein can be sterilized (e.g., with heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure that it is safe for use by patients, and as a step in the steps of the method, any method in the method herein can include the sterilization of the associated systems, devices, equipment, etc. Examples of heating / thermal sterilization include steam sterilization and autoclave sterilization. Examples of radiation for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beams. Examples of chemicals for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. For example, the sterilization carried out with hydrogen peroxide can be completed using hydrogen peroxide plasma.

[0176] Additional Examples of the Disclosed Technology

[0177] In view of the above embodiments of the disclosed subject matter, the present application discloses the additional embodiments listed below. It should be noted that one feature of a separate example or more than one feature of a combination of examples and optionally combined with one or more features of one or more other examples are additional examples that also fall within the disclosure of the present application.

[0178] Example 1. A prosthetic heart valve, comprising: a radially expandable and radially compressible annular frame, the radially expandable and radially compressible annular frame comprising a plurality of interconnected angled struts, the plurality of interconnected angled struts defining a plurality of rows of circumferentially extending pores arranged between an inflow end and an outflow end of the frame, wherein the plurality of interconnected angled struts are arranged to form a plurality of rows of circumferentially extending struts, 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, and a third row of struts upstream of the second row of struts, wherein the plurality of rows of circumferentially extending pores comprise: a first row of first pores, the first row of first pores being disposed at the outflow end and being at least partially defined by the first row of struts and the The second row of struts is defined; and a second row of second chambers, which are arranged upstream of the first row of first chambers and are at least partially defined by the second row of struts and the third row of struts, wherein the first width of each first chamber in the first row of first chambers is greater than the second width of each second chamber in the second row of second chambers, and wherein the second row of struts includes a plurality of free apex areas, and wherein each free apex area connects together adjacent ends of a corresponding pair of angled struts in the second row of struts, and has a first surface facing in a downstream direction and an opposite second surface facing in an upstream direction, wherein the first surface has a constant convex curvature extending between the adjacent ends of the corresponding pair of angled struts.

[0179] Example 2. According to any example herein, in particular the prosthetic heart valve described in Example 1, wherein the second surface of each free apex region defines a recessed region between the adjacent ends of the corresponding 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 the corresponding pair of angled struts.

[0180] Example 3. A prosthetic heart valve according to any example herein, specifically 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 the corresponding pair of angled struts to the downstream-facing surface of the second angled strut of the corresponding pair of angled struts, the surface of the first angled strut being disposed on a first side of the free apex region and the surface of the second angled strut being disposed on an opposite second side of the free apex region.

[0181] Example 4. A prosthetic heart valve according to any example herein, particularly any one of Examples 1 to 3, wherein the first width is twice the second width.

[0182] Example 5. A prosthetic heart valve according to any example herein, particularly any one of Examples 1 to 4, wherein the first row of first chambers includes six chambers and the second row of second chambers includes twelve chambers.

[0183] Example 6. A prosthetic heart valve according to any example herein, specifically any one of Examples 1 to 5, 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 an axial side of the first row of first chambers.

[0184] Example 7. A prosthetic heart valve according to any example herein, specifically Example 6, wherein the struts of a first portion of the second row of struts form pairs of angled struts, each of which is connected to a corresponding axially extending strut among the plurality of axially extending struts, wherein the struts of a second portion of the second row of struts form pairs of angled struts, each of which is connected to a corresponding axially extending strut among the plurality of axially extending struts, and wherein the plurality of free apex regions are not attached to the plurality of axially extending struts.

[0185] Example 8. A prosthetic heart valve according to any example herein, particularly Example 6 or Example 7, wherein a portion of the plurality of axially extending struts are axially extending window struts defining a commissure window, the prosthetic heart valve further comprising a plurality of leaflets fixed together at adjacent sides thereof to form a commissure, and wherein the commissure is fixed to the commissure window of the frame.

[0186] Example 9. A prosthetic heart valve according to any example herein, specifically any one of Examples 1 to 8, wherein the first row of struts forms pairs of angled struts, wherein the struts in each pair of angled struts in the first row are connected together at their adjacent ends by an outflow apex region, and wherein the outflow apex region is bent between the pair of angled struts and has a narrowed width relative to the pair of angled struts.

[0187] Example 10. A prosthetic heart valve according to any example herein, in particular Example 9, wherein the outflow apex region has a third surface and an opposing fourth surface facing the upstream direction, and wherein the third surface has a constant convex curvature extending between the pair of angled struts.

[0188] Example 11. A prosthetic heart valve according to any example herein, particularly any one of Examples 1 to 10, wherein a first axial length of each first chamber in the first row of first chambers is longer than a second axial length of each second chamber in the second row of second chambers.

[0189] Example 12. A prosthetic heart valve according to any example herein, specifically any one of Examples 1 to 11, wherein the frame further comprises a plurality of horizontal struts extending between adjacent second pores in the second row of second pores, and wherein each of the plurality of horizontal struts connects two adjacent struts in the second row of struts to two adjacent struts in the third row of struts.

[0190] Example 13. A prosthetic heart valve according to any example herein, in particular Example 12, wherein the length of each horizontal strut in the circumferential direction is specified to maintain a specified gap between the two adjacent struts in the second row of struts and the two adjacent struts in the third row of struts when the frame is in a radially compressed configuration.

[0191] Example 14. A prosthetic heart valve according to any example herein, in particular 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 vertical orientation relative to a central longitudinal axis of the frame.

[0192] Example 15. A prosthetic heart valve according to any example herein, in particular Example 13, wherein in the radially compressed configuration, the second row of struts and the third row of struts extend axially but are angled inwardly toward each other at adjacent horizontal struts.

[0193] Example 16. A prosthetic heart valve according to any example herein, particularly any one of Examples 1 to 15, wherein the first width of each strut in the first row of struts is greater than the second width of each strut in the second row of struts.

[0194] Example 17. A prosthetic heart valve according to any example herein, in particular Example 16, wherein the multiple rows of circumferentially extending struts further include a fourth row of struts at the inflow end of the frame, and wherein each strut in the fourth row of struts has a third width that is less than the first width and greater than the second width.

[0195] Example 18. According to any example herein, specifically a prosthetic heart valve as described in any of Examples 1 to 17, further comprising a plurality of leaflets secured to the interior of the frame and configured to open and close to regulate the flow of blood from the inflow end of the frame through the prosthetic heart valve to the outflow end, 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 opens and closes during operation of the prosthetic heart valve.

[0196] Example 19. A prosthetic heart valve, comprising: a radially expandable and radially collapsible annular frame, the radially expandable and radially collapsible annular frame comprising a plurality of interconnected struts, the plurality of interconnected struts defining a plurality of rows of circumferentially extending chambers arranged between an inflow end and an outflow end of the frame, wherein the plurality of interconnected struts comprise: a plurality of rows of circumferentially extending angled struts, the plurality of rows of circumferentially extending angled struts comprising a first row of struts at the outflow end of the frame, a second row of struts upstream of the first row of struts, and a third row of struts upstream of the second row of struts; and a plurality of axial struts circumferentially spaced around the frame and extending between the first row of struts and the second row of struts, wherein the plurality of rows of circumferentially extending chambers comprise: a first row of first chambers, the first row of first chambers being disposed at the outflow end and being at least partially defined by the first row of struts and the second row of struts and the plurality of axial struts; and a second row of second chambers, the second row of second chambers The chamber is disposed upstream of the first row of first holes and is at least partially defined by the second row of struts and the third row of struts, wherein the first width of each first hole in the first row of first holes is greater than the second width of each second hole in the second row of second holes, and wherein the second row of second holes includes: a first portion of the second hole defined by a first pair of angled struts of the second row of struts; and a second portion of the second hole defined by a second pair of angled struts and a plurality of free apex regions of the second row of struts, the second row of struts being directly connected to the plurality of axial struts at adjacent ends thereof, wherein each free apex region connects the adjacent ends of the corresponding second pair of angled struts together and has a first surface facing in a downstream direction and an opposite second surface facing in an upstream direction, wherein the first surface has a constant convex curvature extending between the adjacent ends of the corresponding second pair of angled struts, and wherein the plurality of free apex regions are not attached to the plurality of axial struts.

[0197] Example 20. According to any example herein, in particular the prosthetic heart valve described in Example 19, wherein the second surface of each free apex region defines an inner recessed portion, wherein the inner recessed portion is recessed inwardly toward the first surface of the apex region from the upstream-facing surface of the corresponding second pair of angled struts, such that the width of the apex region between its first and second surfaces is less than the width of the corresponding second pair of angled struts.

[0198] Example 21. A prosthetic heart valve according to any example herein, particularly Example 19 or Example 20, wherein each strut in the first row of struts comprises two angled strut portions interconnected by an outflow apex region, and wherein the outflow apex region bends between the two angled strut portions, has a constant convex curvature at its downstream-facing surface, and has a narrowing relative to the two angled strut portions.

[0199] Example 22. A prosthetic heart valve according to any example herein, in particular Example 21, wherein each outflow apex region forms an angle greater than 120 degrees between the two angled strut portions.

[0200] Example 23. A prosthetic heart valve according to any example herein, particularly example 21 or example 22, wherein each outflow apex region is aligned with and axially spaced apart from a corresponding free apex region.

[0201] Example 24. A prosthetic heart valve according to any example herein, particularly any one of Examples 19 to 23, wherein the first width is twice the second width.

[0202] Example 25. A prosthetic heart valve according to any example herein, particularly any one of Examples 19 to 24, wherein a first axial length of each first chamber in the first row of first chambers is longer than a second axial length of each second chamber in the second row of second chambers.

[0203] Example 26. According to any example herein, specifically a prosthetic heart valve as described in any of Examples 19 to 25, further comprising a plurality of leaflets secured to the interior of the frame and configured to open and close to regulate the flow of blood from the inflow end of the frame through the prosthetic heart valve to the outflow end, 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 opens and closes during operation of the prosthetic heart valve.

[0204] Example 27. A prosthetic heart valve according to any example herein, specifically Example 26, wherein the frame is radially expandable and radially collapsible between a radially expanded configuration and a radially compressed configuration, and wherein the frame further includes a plurality of horizontal struts extending between adjacent second pores in the second row of second pores, wherein each of the plurality of horizontal struts connects two adjacent struts in the second row of struts to two adjacent struts in the third row of struts, and is configured to maintain a specified gap between the two adjacent struts in the second row of struts and the two adjacent struts in the third row of struts when the frame is in a radially collapsed configuration.

[0205] Example 28. A prosthetic heart valve according to any example herein, particularly any one of Examples 19 to 27, wherein the first width of each strut in the first row of struts is greater than the second width of each strut in the second row of struts.

[0206] Example 29. A prosthetic heart valve according to any example herein, particularly Example 28, wherein the multiple rows of circumferentially extending angled struts further include a fourth row of struts at the inflow end of the frame, and wherein each strut in the fourth row of struts has a third width that is less than the first width.

[0207] Example 30. A prosthetic heart valve comprising: a radially expandable and radially collapsible annular frame, the radially expandable and radially collapsible annular frame comprising a plurality of interconnected struts, the plurality of interconnected struts defining a plurality of rows of circumferentially extending pores arranged between an outflow end and an inflow end of the frame, wherein the plurality of interconnected struts comprise: a row of circumferentially extending first struts, the row of circumferentially extending first struts defining the outflow end, each first strut comprising two angled strut portions interconnected by an outflow apex region, wherein the outflow apex region is bent between the two angled strut portions and has a width relative to the width of the two angled strut portions. having a narrowing width; a plurality of axially extending struts, the plurality of axially extending struts being spaced circumferentially around the frame and connected to the row of first struts; a row of circumferentially extending angled second struts, the row of circumferentially extending angled second struts being disposed upstream of the row of first struts, wherein a first portion of the second struts in the row of angled second struts are each directly connected to a corresponding axially extending strut in the plurality of axially extending struts, and wherein a second portion of the second struts in the row of angled second struts form pairs of second struts, the pairs of second struts being connected by free apex regions that are not attached to the plurality of axially extending struts together, wherein the free apex region of each corresponding pair of second struts has a first surface facing in a downstream direction and an opposite second surface facing in an upstream direction, wherein the first surface is curved between the corresponding pair of second struts, and wherein the second surface is recessed inwardly toward the first surface so that a width of the free apex region between the first surface and the second surface is less than a width of the corresponding pair of second struts; and a row of circumferentially extending angled third struts, wherein the row of first struts, the axially extending struts and the row of angled second struts form a first row of pore chambers of the plurality of rows of pore chambers disposed at the outflow end, wherein the one A row of angled second struts and the row of angled third struts form a second row of pores in the multiple rows of pores positioned adjacent to the first row of pores, and wherein a first width of each pore in the first row of pores is wider than a second width of each pore in the second row of pores; and a plurality of leaflets secured to the interior of the frame and configured to open and close to regulate the flow of blood from the inflow end of the frame through the prosthetic heart valve to the outflow end, wherein each free apex region of the row of angled second struts is positioned at a level of a portion of the plurality of leaflets that opens and closes during operation of the prosthetic heart valve.

[0208] Example 31. A prosthetic heart valve according to any example herein, in particular Example 30, wherein the first surface of each free apex region has a constant convex curvature between downstream-facing surfaces of the corresponding pair of second struts.

[0209] Example 32. A prosthetic heart valve according to any example herein, particularly Example 30 or Example 31, wherein the outflow apex region of each first strut forms an angle greater than 120 degrees between the two angled strut portions.

[0210] Example 33. A prosthetic heart valve according to any example herein, specifically any one of Examples 30 to 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 with a convex curvature from one of the two angled strut portions located on a first side of the outflow apex region to the other of the two angled strut portions located on a second side of the outflow apex region.

[0211] Example 34. A prosthetic heart valve according to any example herein, particularly any one of Examples 30 to 33, wherein the first width is twice the second width.

[0212] Example 35. A prosthetic heart valve according to any example herein, particularly any one of Examples 30 to 34, wherein a first axial length of each pore in the first row of pores is longer than a second axial length of each pore in the second row of pores.

[0213] Example 36. A prosthetic heart valve according to any example herein, specifically any one of Examples 30 to 35, wherein the frame is radially expandable and radially collapsible between a radially expanded configuration and a radially collapsed configuration, and wherein the frame further includes a plurality of horizontal struts extending between adjacent pores in the second row of pores, wherein each of the plurality of horizontal struts connects two adjacent second struts in the row of angled second struts and two adjacent third struts in the row of angled third struts together, and is configured to maintain a specified gap in a circumferential direction between the two adjacent second struts and the two adjacent third struts when the frame is in a radially collapsed configuration.

[0214] Example 37. A prosthetic heart valve according to any example herein, particularly any one of Examples 30 to 36, wherein the width of the two angled strut portions of each first strut in the row of first struts is greater than the width of each second strut in the row of angled second struts.

[0215] Example 38. A prosthetic heart valve according to any example herein, specifically Example 37, wherein the plurality of interconnected struts further include a row of circumferentially extending angled fourth struts at the inflow end of the frame, and wherein the width of each fourth strut in the row of angled fourth struts is less than the width of the two angled strut portions of each first strut.

[0216] Example 39. An assembly comprising: a delivery device comprising a balloon; and an implantable prosthetic heart valve, the implantable prosthetic heart valve being radially collapsible into a collapsed configuration and radially expandable into an expanded configuration, comprising: a radially expandable and radially compressible annular frame, the radially expandable and radially compressible annular frame comprising a plurality of interconnected angled struts, the plurality of interconnected angled struts defining a plurality of rows of circumferentially extending pores arranged between an inflow end and an outflow end of the frame, wherein the plurality of interconnected angled struts are arranged to form a plurality of rows of circumferentially extending struts, 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, and a third row of struts upstream of the second row of struts, wherein the plurality of rows of circumferentially extending pores comprise: a first row of first chambers, the first row of first chambers being disposed at the outflow end and being at least partially defined by the first row of struts and the second row of struts; and a second row of second chambers, the second row of A second chamber is disposed upstream of the first row of first chambers and is at least partially defined by the second row of struts and the third row of struts, wherein the first width of each first chamber in the first row of first chambers is greater than the second width of each second chamber in the second row of second chambers, and wherein the second row of struts includes a plurality of free apex regions, and wherein each free apex region connects together a corresponding pair of angled struts in the second row of struts and has a first surface facing the outflow end of the frame and an opposite second surface facing the inflow end of the frame, wherein the first surface forms a single continuous convex curve from one of the corresponding pair of angled struts on the first side of the free apex region to the other of the corresponding pair of angled struts on the opposite second side of the free apex region, wherein the collapsed prosthetic heart valve can be mounted around the balloon and radially expanded to an expanded configuration of the balloon inside the patient's body.

[0217] Example 40. The assembly of any example herein, particularly Example 39, wherein the width of each free apex region between the first surface and the second surface of the free apex region is less than the width of the corresponding pair of angled struts.

[0218] Example 41. An assembly according to any example herein, specifically Example 39 or Example 40, wherein the second surface of each free vertex region defines a recess between the first side and the second side of the free vertex region, the recess being recessed toward the first surface so that the width of the free vertex region between the first surface and the second surface is less than the width of the corresponding pair of angled pillars.

[0219] Example 42. The assembly of any example herein, particularly any one of examples 39 to 41, wherein the first width is twice the second width.

[0220] Example 43. An assembly according to any example herein, particularly any one of Examples 39 to 41, wherein the first row of first cells includes half the number of cells included in the second row of second cells.

[0221] Example 44. An assembly according to any example herein, specifically any one of Examples 39 to 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 an axial side of the first row of first pores.

[0222] Example 45. An assembly according to any example herein, specifically Example 44, wherein the struts of a first portion of the second row of struts form pairs of angled struts, each of which is connected to a corresponding axially extending strut among the plurality of axially extending struts, wherein the struts of a second portion of the second row of struts form pairs of angled struts, each of which is connected to a corresponding axially extending strut among the plurality of axially extending struts, wherein the struts of a second portion of the second row of struts form pairs of angled struts, each of which is connected through a corresponding free apex region among the plurality of apex regions, and wherein the plurality of free apex regions are not attached to the plurality of axially extending struts.

[0223] Example 46. An assembly according to any example herein, particularly 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 cusp edge portion extending between the opposing commissure tabs, wherein a portion of the plurality of axially extending struts are axially extending window struts defining commissure windows, and wherein the commissure tabs of adjacent leaflets are paired together and secured to corresponding commissure windows of the frame.

[0224] Example 47. An assembly according to any example herein, specifically any one of Examples 39 to 46, wherein the first row of struts forms pairs of angled struts, wherein the struts in each pair of angled struts are connected together at their adjacent ends by an outflow apex region, and wherein the outflow apex region bends between the pair of angled struts and has a narrowed width relative to the pair of angled struts.

[0225] Example 48. An assembly according to 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, and wherein the third surface has a constant convex curvature extending between the pair of angled struts.

[0226] Example 49. An assembly according to any example herein, particularly any one of Examples 39 to 48, wherein a first axial length of each first cell in the first row of first cells is longer than a second axial length of each second cell in the second row of second cells.

[0227] Example 50. An assembly according to any example herein, specifically any one of Examples 39 to 49, wherein the frame further comprises a plurality of horizontal struts extending between adjacent second pore chambers in the second row of second pore chambers, and wherein each of the plurality of horizontal struts connects two adjacent struts in the second row of struts to two adjacent struts in the third row of struts.

[0228] Example 51. An assembly according to any example herein, specifically Example 50, wherein the length of each horizontal strut in the circumferential direction is specified to maintain a specified gap between the two adjacent struts in the second row of struts and the two adjacent struts in the third row of struts when the frame is in the collapsed configuration, and wherein in the collapsed configuration, the struts in the first row of struts, the second row of struts, and the third row of struts present a configuration that is more axially extended than when the frame is in the expanded configuration.

[0229] Example 52. An assembly according to any example herein, particularly any one of Examples 39 to 51, wherein the first width of each strut in the first row of struts is greater than the second width of each strut in the second row of struts.

[0230] Example 53. An assembly according to any example herein, particularly Example 52, wherein the multiple rows of circumferentially extending struts further include a fourth row of struts at the inflow end of the frame, and wherein each strut in the fourth row of struts has a third width that is less than the first width and greater than the second width.

[0231] Example 54. An assembly according to any example herein, specifically any one of Examples 39 to 53, wherein the prosthetic heart valve further comprises a plurality of leaflets secured to the interior of the frame and configured to open and close to regulate the flow of blood from the inflow end of the frame through the prosthetic heart valve to the outflow end, 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 opens and closes during operation of the prosthetic heart valve.

[0232] Example 55. A prosthetic heart valve, comprising: a radially expandable and radially compressible annular frame, the radially expandable and radially compressible annular frame comprising a plurality of interconnected angled struts, the plurality of interconnected angled struts defining a plurality of rows of circumferentially extending pores arranged 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 rows of circumferentially extending struts, including a first row of struts at the first end of the frame, a second row of struts disposed adjacent to the first row of struts, and a third row of struts disposed adjacent to the second row of struts, the second row of struts being disposed between the first row of struts and the third row of struts, wherein the plurality of rows of circumferentially extending pores comprise: a first row of first pores, the first row of first pores being disposed at the first end, and at least partially The frame is defined by the first row of struts and the second row of struts; and a second row of second pores, which are arranged adjacent to the first row of first pores and are at least partially defined by the second row of struts and the third row of struts, wherein the first width of each first pore in the first row of first pores is greater than the second width of each second pore in the second row of second pores, and wherein the second row of struts includes a plurality of free vertex areas, and wherein each free vertex area connects together adjacent ends of a corresponding pair of angled struts in the second row of struts, and has a first surface facing the first end of the frame and an opposite second surface facing the second end of the frame, wherein the first surface has a constant convex curvature extending between the adjacent ends of the corresponding pair of angled struts.

[0233] Example 56. According to any example herein, in particular the prosthetic heart valve described in Example 55, wherein the second surface of each free apex region defines a recessed region between the adjacent ends of the corresponding 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 the corresponding pair of angled struts.

[0234] Example 57. A prosthetic heart valve according to any example herein, specifically Example 55 or Example 56, wherein the first surface of the free apex region forms a single continuous curve from the surface of a first angled strut in the corresponding pair of angled struts to the surface of a second angled strut in the corresponding pair of angled struts, the surface of the first angled strut facing the first end of the frame and disposed on a first side of the free apex region, and the surface of the second angled strut facing the second end of the frame and disposed on an opposite second side of the free apex region.

[0235] Example 58. A prosthetic heart valve according to any example herein, particularly any one of Examples 55 to 57, wherein the first width is twice the second width.

[0236] Example 59. A prosthetic heart valve according to any example herein, particularly any one of Examples 55 to 58, wherein the first row of first chambers includes six chambers and the second row of second chambers includes twelve chambers.

[0237] Example 60. A prosthetic heart valve according to any example herein, specifically any one of Examples 55 to 59, 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 an axial side of the first row of first chambers.

[0238] Example 61. A prosthetic heart valve according to any example herein, specifically Example 60, wherein the struts of a first portion of the second row of struts form pairs of angled struts, each of the pairs of angled struts being connected to a corresponding axially extending strut among the plurality of axially extending struts, wherein the struts of a second portion of the second row of struts form pairs of angled struts, the pairs of angled struts being connected via corresponding free apex regions among the plurality of apex regions, and wherein the plurality of free apex regions are not attached to the plurality of axially extending struts.

[0239] Example 62. A prosthetic heart valve according to any example herein, specifically Example 60 or Example 61, wherein a portion of the plurality of axially extending struts are axially extending window struts that define a commissure window, the prosthetic heart valve further comprising a plurality of leaflets secured together at adjacent sides thereof to form a commissure, and wherein the commissure is secured to the commissure window of the frame.

[0240] Example 63. A prosthetic heart valve according to any example herein, specifically any one of Examples 55 to 62, wherein the first row of struts forms pairs of angled struts, wherein the struts in each pair of angled struts are connected together at their adjacent ends by an outflow apex region, and wherein the outflow apex region is bent between the pair of angled struts and has a narrowed width relative to the pair of angled struts.

[0241] Example 64. A prosthetic heart valve according to any example herein, particularly Example 63, wherein the outflow apex region has a third surface and a fourth surface opposite the second end of the frame, and wherein the third surface has a constant convex curvature extending between the pair of angled struts.

[0242] Example 65. A prosthetic heart valve according to any example herein, specifically any one of Examples 55 to 64, wherein a first axial length of each first chamber in the first row of first chambers is longer than a second axial length of each second chamber in the second row of second chambers.

[0243] Example 66. A prosthetic heart valve according to any example herein, specifically any one of Examples 55 to 65, wherein the frame further comprises a plurality of horizontal struts extending between adjacent second pores in the second row of second pores, and wherein each of the plurality of horizontal struts connects two adjacent struts in the second row of struts to two adjacent struts in the third row of struts.

[0244] Example 67. A prosthetic heart valve according to any example herein, in particular Example 66, wherein the length of each horizontal strut in the circumferential direction is specified to maintain a specified gap between the two adjacent struts in the second row of struts and the two adjacent struts in the third row of struts when the frame is in a radially compressed configuration.

[0245] Example 68. A prosthetic heart valve according to any example herein, in particular Example 67, wherein in the radially compressed configuration, the second row of struts and the third row of struts are axially oriented in a relatively straight vertical orientation relative to a central longitudinal axis of the frame.

[0246] Example 69. A prosthetic heart valve according to any example herein, in particular Example 67, wherein in the radially compressed configuration, the second row of struts and the third row of struts extend axially but are angled inwardly toward each other at adjacent horizontal struts.

[0247] Example 70. A prosthetic heart valve according to any example herein, particularly any one of Examples 55 to 69, wherein the first width of each strut in the first row of struts is greater than the second width of each strut in the second row of struts.

[0248] Example 71. A prosthetic heart valve according to any example herein, specifically Example 70, wherein the multiple rows of circumferentially extending struts further include a fourth row of struts at the second end of the frame, and wherein each strut in the fourth row of struts has a third width that is less than the first width and greater than the second width.

[0249] Example 72. A prosthetic heart valve according to any example herein, specifically any one of Examples 55 to 71, further comprising a plurality of leaflets secured to the interior of the frame and configured to open and close to regulate the flow of blood from the second end of the frame through the prosthetic heart valve to the first end, 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 opens and closes during operation of the prosthetic heart valve.

[0250] Example 73. A prosthetic heart valve according to any example herein, particularly any one of Examples 55 to 72, wherein the first end is an outflow end of the frame and the second end is an inflow end of the frame.

[0251] Example 74. A prosthetic heart valve comprising: a radially expandable and radially compressible annular frame, the radially expandable and radially compressible annular frame comprising a plurality of interconnected struts, the plurality of interconnected struts defining a plurality of rows of circumferentially extending pores arranged between an inflow end and an outflow end of the frame, the plurality of interconnected struts comprising: a row of circumferentially extending outflow struts, the row of circumferentially extending outflow struts defining the outflow end, wherein each outflow strut comprises two angled strut portions interconnected by an apex region, wherein each apex region bends between a corresponding pair of the two angled strut portions and has a narrowing width and a length extending along at least 25% of the total length of the outflow strut, wherein the narrowed width is less than the width of the two angled strut portions; and a row of circumferentially extending angled first struts, wherein the row of circumferentially extending angled first struts is disposed upstream of the row of outflow struts, wherein the row of outflow struts and the row of angled first struts at least partially form a first row of pores of the multiple rows of circumferentially extending pores disposed at the outflow end, and wherein a first width of each pore in the first row of pores is greater than a second width of pores in the remaining rows of pores of the multiple rows of circumferentially extending pores.

[0252] Example 75. A prosthetic heart valve according to any example herein, in particular Example 74, wherein the first width is twice the second width.

[0253] Example 76. A prosthetic heart valve according to any example herein, specifically Example 74 or Example 75, wherein the plurality of interconnected struts further include a row of circumferentially extending angled second struts disposed upstream of the row of angled first struts, and wherein the row of angled first struts and the row of angled second struts form a second row of pores among the plurality of rows of pores, the second row of pores being disposed adjacent to and upstream of the first row of pores, and wherein the second width of each pore in the second row of pores is half of the first width.

[0254] Example 77. A prosthetic heart valve according to any example herein, specifically Example 76, wherein the first struts of a portion of the row of angled first struts form pairs of first struts, and the pairs of first struts are connected together by free apex regions that are not attached to additional struts forming the first row of pore chambers, wherein the free apex regions of each corresponding pair of second struts have a first surface facing a downstream direction and an opposite second surface facing an upstream direction, wherein the first surface is bent between the corresponding pair of second struts, and wherein the second surface is recessed inwardly toward the first surface so that the width of the free apex region between the first surface and the second surface is less than the width of the corresponding pair of second struts.

[0255] Example 78. A prosthetic heart valve according to any example herein, specifically any one of Examples 74 to 77, wherein the plurality of interconnected struts further include a plurality of axially extending struts extending between the row of outflow struts and the row of angled first struts and defining an axial side of the first row of orifices.

[0256] Example 79. A prosthetic heart valve according to any example herein, particularly any one of Examples 74 to 78, wherein each pore in the first row of pores has a longer axial length than pores in the remaining rows of pores.

[0257] Example 80. According to any example herein, specifically the prosthetic heart valve of any one of Examples 74 to 79, further comprising a plurality of leaflets secured to the interior of the frame and configured to open and close to regulate the flow of blood from the inflow end of the frame through the prosthetic heart valve to the outflow end.

[0258] Example 81. A prosthetic heart valve according to any example herein, particularly any one of Examples 74 to 80, wherein the narrowed width of each apex region is 0.06 mm to 0.15 mm smaller than the width of the two angled strut portions.

[0259] Example 82. According to any example herein, specifically a prosthetic heart valve described in any one of Examples 1 to 81, further comprising an inner skirt disposed around the inner surface of the frame, wherein an outflow edge portion of the inner skirt is fixed to the second row of struts, and wherein at each free apex region, the outflow edge portion is disposed upstream of the free apex region.

[0260] Example 83. A prosthetic heart valve according to any example herein, in particular Example 82, wherein the outflow edge portion is folded upon itself such that the outflow edge of the inner skirt is disposed between the inner surface of the frame and an adjacent portion of the inner skirt.

[0261] Example 84. A prosthetic heart valve according to any example herein, particularly Example 82 or Example 83, wherein the outflow edge portion of the inner skirt is secured to the second row of struts by a plurality of sutures.

[0262] Example 85. A prosthetic heart valve according to any example herein, particularly any one of Examples 82 to 84, wherein each apex region is uncovered by the inner skirt.

[0263] Example 86. A prosthetic heart valve, comprising: a radially expandable and radially compressible annular frame, the radially expandable and radially compressible annular frame comprising a plurality of interconnected angled struts, the plurality of interconnected angled struts defining a plurality of rows of circumferentially extending pores arranged 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 rows of circumferentially extending struts, including a first row of struts at the first end of the frame, a second row of struts disposed adjacent to the first row of struts, and a third row of struts disposed adjacent to the second row of struts, the second row of struts being disposed between the first row of struts and the third row of struts, wherein the plurality of rows of circumferentially extending pores comprise: a first row of first pores, the first row of first pores being disposed at the first end and being at least partially defined by the first row of struts and the second row of struts. The frame is defined by pillars; and a second row of second cells, which are arranged adjacent to the first row of first cells and are at least partially defined by the second row of pillars and the third row of pillars, wherein the first width of each first cell in the first row of first cells is greater than the second width of each second cell in the second row of second cells, and wherein the second row of pillars includes a plurality of free vertices, and wherein each free vertex connects together adjacent ends of a corresponding pair of angled pillars in the second row of pillars; and an inner skirt arranged around the inner surface of the frame, wherein a first edge portion of the inner skirt is fixed to the second row of pillars, wherein at each free vertex, the first edge portion is arranged away from the free vertex toward the second end of the frame, and wherein the second edge portion of the inner skirt is arranged at the second end of the frame.

[0264] Example 87. A prosthetic heart valve according to any example herein, in particular Example 86, wherein the first edge portion is folded upon itself such that an outer first edge of the inner skirt is disposed between the inner surface of the frame and an adjacent portion of the inner skirt.

[0265] Example 88. A prosthetic heart valve according to any example herein, particularly Example 86 or Example 87, wherein the first edge portion of the inner skirt is secured to the second row of struts by a plurality of sutures.

[0266] Example 89. A prosthetic heart valve according to any example herein, particularly any one of Examples 86 to 88, wherein each free apex is uncovered by the inner skirt.

[0267] Example 90. A prosthetic heart valve according to any example herein, specifically any one of Examples 86 to 89, wherein the first end of the frame is an outflow end and the second end of the frame is an inflow end, wherein the first edge portion of the inner skirt is the outflow edge portion, and wherein at each free vertex, the outflow edge portion of the inner skirt is positioned upstream of the free vertex.

[0268] Example 91. A prosthetic heart valve according to any example herein, specifically any one of Examples 86 to 90, wherein each free vertex has a first surface facing the first end of the frame and an opposing second surface facing the second end of the frame, and wherein the first surface has a constant convex curvature extending between the adjacent ends of the corresponding pair of angled struts.

[0269] Example 92. A prosthetic heart valve comprising: a radially expandable and radially compressible annular frame, the radially expandable and radially compressible annular frame comprising a plurality of interconnected angled struts, the plurality of interconnected angled struts being arranged to form a plurality of rows of circumferentially extending struts, 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 the inner surface of the frame, wherein the skirt comprises an inflow edge and an outflow edge, wherein the outflow edge is sewn to the struts in the second row of struts and comprises a plurality of peaks spaced apart from each other in a circumferential direction, wherein the peaks are aligned with corresponding vertices of the second row of struts, and wherein at least one peak has a straight edge spaced apart from the corresponding vertex toward the inflow end of the frame.

[0270] Example 93. A prosthetic heart valve according to any example herein, in particular Example 92, wherein the at least one peak is folded to form a fold line, and the fold line forms the straight edge.

[0271] Example 94. A prosthetic heart valve according to any example herein, specifically any one of Examples 92 or 93, wherein a first group of vertices of the second row of struts are connected to the third row of struts via axially extending struts, and a second group of vertices of the second row of struts are free vertices that are not connected to any axially extending struts of the third row of struts, wherein the outflow edge of the skirt comprises a plurality of first peaks aligned with vertices in the first group of vertices and a plurality of second peaks having straight edges aligned with corresponding free vertices of the second row of struts.

[0272] Example 95. A prosthetic heart valve according to any example herein, in particular Example 94, wherein each second peak is positioned between two adjacent first peaks.

[0273] Example 96. A prosthetic heart valve according to any example herein, particularly any one of Examples 94 to 95, wherein the first peak is sharp.

[0274] Example 97. A prosthetic heart valve according to any example herein, particularly any one of Examples 94 to 96, wherein the first peak extends axially toward the outflow end of the frame to a greater extent than the second peak.

[0275] Example 98. A prosthetic heart valve according to any example herein, particularly any one of Examples 94 to 97, wherein the second peak is folded and the first peak is not folded.

[0276] Example 99. A prosthetic heart valve according to any example herein, specifically any one of Examples 94 to 98, wherein each of the free vertices connects adjacent ends of a corresponding pair of struts of the second row of struts, and wherein each free vertex has a first surface facing a downstream direction and an opposite second surface facing an upstream direction, wherein the first surface has a constant convex curvature extending between the adjacent ends of the corresponding pair of struts.

[0277] Example 100. A prosthetic heart valve according to any example herein, specifically any one of Examples 94 to 99, further comprising a plurality of leaflets secured to an interior of the frame and configured to open and close to regulate the flow of blood from the inflow end of the frame through the prosthetic heart valve to the outflow end, wherein each free vertex of the second row of struts is positioned at a level of a portion of the plurality of leaflets that opens and closes during operation of the prosthetic heart valve.

[0278] Example 101. A prosthetic heart valve according to any example herein, specifically any one of Examples 92 to 100, wherein the frame includes multiple rows of circumferentially extending pores, the multiple rows of circumferentially extending pores comprising: an outflow row of first pores, the outflow row of first pores being at least partially defined by the second row of struts and the third row of struts; and a second row of second pores, the second row of second pores being located upstream of the first row of first pores and being at least partially defined by the first row of struts and the second row of struts, wherein a first width of each first pore in the first row of first pores is greater than a second width of each second pore in the second row of second pores.

[0279] Example 102. A prosthetic heart valve according to any example herein, in particular Example 101, wherein the first width is twice the second width.

[0280] Example 103. A prosthetic heart valve according to any example herein, particularly any one of Examples 92 to 102, further comprising an outer skirt disposed around an outer surface of the frame.

[0281] Example 104. A prosthetic heart valve according to any example herein, specifically any one of Examples 92 to 103, wherein the frame is radially expandable and radially compressible between a radially expanded configuration and a radially compressed configuration, and wherein the straight edge of at least one of the peaks is configured to slide upstream on the frame, slide farther upstream from the corresponding apex region when the frame is radially compressed, and slide downstream on the frame toward but not all the way to the corresponding apex region.

[0282] Example 105. A prosthetic heart valve, comprising: a radially expandable and radially compressible annular frame, the radially expandable and radially compressible annular frame comprising a plurality of interconnected angled struts, the plurality of interconnected angled struts defining a plurality of rows of circumferentially extending pores arranged between an inflow end and an outflow end of the frame, wherein the plurality of interconnected angled struts are arranged to form a plurality of rows of circumferentially extending struts, 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, and a third row of struts upstream of the second row of struts, wherein the plurality of rows of circumferentially extending pores comprise: a first row of first pores, the first row of first pores being disposed at the outflow end and being at least partially defined by the first row of struts and the second row of struts, and an axial A second row of second chambers, the second row of second chambers being disposed upstream of the first row of first chambers and being at least partially defined by the second row of chambers and the third row of chambers, wherein the second row of chambers comprises a plurality of free apex regions, the plurality of free apex regions being not connected to the first row of chambers through axially extending chambers, and wherein each free apex region connects together adjacent ends of a corresponding pair of angled chambers in the second row of chambers, and having a first surface facing in a downstream direction, an opposite second surface facing in an upstream direction, and a width measured from the first surface to the second surface, wherein the width is less than the width of the chambers connected by the free apex regions.

[0283] Example 106. A prosthetic heart valve according to any example herein, particularly Example 105, wherein the first surface has a constant convex curvature extending between the adjacent ends of the corresponding pair of angled struts.

[0284] Example 107. A prosthetic heart valve according to any one of claims 105-106 wherein the first aperture chamber is wider than the second aperture chamber.

[0285] Example 108. The prosthetic heart valve of any one of Claims 105-107 wherein the second surface forms a recess in the free apex region.

[0286] Example 109. A prosthetic heart valve according to any example herein, particularly any one of Examples 105 to 108, wherein the number of chambers in the second row of second chambers is twice the number of chambers in the first row of first chambers.

[0287] Example 110. A prosthetic heart valve according to any one of claims 105 to 109, wherein a portion of the axially extending struts are axially extending window struts that define a commissure window, the prosthetic heart valve further comprising a plurality of leaflets secured together at adjacent sides thereof to form a commissure, and wherein the commissure is secured to the commissure window of the frame.

[0288] Example 111. A prosthetic heart valve according to any example herein, specifically any one of Examples 105 to 110, wherein the first row of struts forms pairs of angled struts, wherein the struts in each pair of angled struts in the first row are connected together at their adjacent ends by an outflow apex region, and wherein the outflow apex region is bent between the pair of angled struts and has a narrowed width relative to the pair of angled struts.

[0289] Example 112. A prosthetic heart valve according to any example herein, particularly Example 111, wherein the outflow apex region has a third surface and an opposing fourth surface facing the upstream direction, and wherein the third surface has a constant convex curvature extending between the pair of angled struts.

[0290] Example 113. A prosthetic heart valve according to any example herein, specifically any one of Examples 105 to 112, wherein a first axial length of each first chamber in the first row of first chambers is longer than a second axial length of each second chamber in the second row of second chambers.

[0291] Example 114. A prosthetic heart valve according to any example herein, specifically any one of Examples 105 to 113, wherein the frame further comprises a plurality of horizontal struts extending between adjacent second pores in the second row of second pores, and wherein each of the plurality of horizontal struts connects two adjacent struts in the second row of struts to two adjacent struts in the third row of struts.

[0292] Example 115. A prosthetic heart valve according to any example herein, in particular Example 114, wherein the length of each horizontal strut in the circumferential direction is specified to maintain a specified gap between the two adjacent struts in the second row of struts and the two adjacent struts in the third row of struts when the frame is in a radially compressed configuration.

[0293] Example 116. A prosthetic heart valve according to any example herein, particularly Example 115, wherein in the radially compressed configuration, the second row of struts and the third row of struts are axially oriented in a relatively straight vertical orientation relative to a central longitudinal axis of the frame.

[0294] Example 117. A prosthetic heart valve according to any example herein, particularly Example 116, wherein in the radially compressed configuration, the second row of struts and the third row of struts extend axially but are angled inwardly toward each other at adjacent horizontal struts.

[0295] Example 118. A prosthetic heart valve according to any example herein, particularly any one of Examples 105 to 117, wherein the first width of each strut in the first row of struts is greater than the second width of each strut in the second row of struts.

[0296] Example 119. A prosthetic heart valve according to any example herein, specifically Example 118, wherein the multiple rows of circumferentially extending struts further include a fourth row of struts at the inflow end of the frame, and wherein each strut in the fourth row of struts has a third width that is less than the first width and greater than the second width.

[0297] Example 120. A prosthetic heart valve according to any example herein, specifically any one of Examples 105 to 119, further comprising a plurality of leaflets secured to an interior of the frame and configured to open and close to regulate the flow of blood from the inflow end of the frame through the prosthetic heart valve to the outflow end, wherein each free apex region of the second row of struts is positioned at a level of a portion of the plurality of leaflets that opens and closes during operation of the prosthetic heart valve.

[0298] Example 121. According to any example herein, specifically a prosthetic heart valve described in any one of Examples 105 to 120, further comprising an inner skirt disposed around the inner surface of the frame, wherein an outflow edge portion of the inner skirt is fixed to the second row of struts, and wherein at each free apex region, the outflow edge portion is disposed upstream of the free apex region.

[0299] Example 122. A prosthetic heart valve according to any example herein, in particular Example 121, wherein the outflow edge portion includes a plurality of peaks spaced apart from one another in a circumferential direction, wherein a portion of the peaks are aligned with corresponding apex regions and are spaced apart from the corresponding apex regions toward the inflow end of the frame.

[0300] Example 123. A prosthetic heart valve according to any example herein, particularly examples 121 or 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.

[0301] Example 124. A prosthetic heart valve according to any example herein, particularly any one of Examples 121 to 124, wherein the outflow edge portion of the inner skirt is secured to the second row of struts by a plurality of sutures.

[0302] Example 125. A method comprising sterilizing a prosthetic heart valve, device, and / or assembly according to any example.

[0303] Example 126. A prosthetic heart valve according to any one of Examples 1 to 124, wherein the prosthetic heart valve is sterilized.

[0304] Unless otherwise stated, features described herein with respect to any example may be combined with other features described in any one or more examples in other examples. For example, any one or more features of the features of a prosthetic valve frame may be combined with any one or more features of another prosthetic valve frame.

[0305] In view of the many possible ways in which the principles of the present disclosure can be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the present disclosure, nor should they be taken as limiting the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A prosthetic heart valve, comprising: a radially expandable and compressible annular frame comprising a plurality of interconnected angled struts defining a plurality of rows of circumferentially extending cells 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 rows of struts, including a first row of struts located at the first end of the frame, a second row of struts disposed adjacent to the first row of struts, and a third row of struts disposed adjacent to the second row of struts, the second row of struts being disposed between the first row of struts and the third row of struts, wherein the plurality of rows of circumferentially extending cells comprise: 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, the second row of second cells being disposed adjacent to the first row of first cells and being at least partially defined by the second row of struts and the third row of struts, wherein The first width of each first cell in the first row of first cells is greater than the second width of each second cell in the second row of second cells, and wherein the second row of struts includes a plurality of free apex regions, and wherein each free apex region connects together adjacent ends of a corresponding pair of angled struts in the second row of struts and has a first surface facing the first end of the frame and an opposing second surface facing the second end of the frame, wherein The first surface has a constant convex curvature extending between the adjacent ends of the respective pair of angled struts.

2. A prosthetic heart valve according to claim 1, wherein the second surface of each free apex region defines a recessed region between the adjacent ends of the corresponding pair of angled struts, so that the width of the free apex region between the first surface and the second surface is less than the width of the corresponding pair of angled struts.

3. A prosthetic heart valve according to claim 1 or claim 2, wherein the first surface of the free apex region forms a single continuous curve from the surface of a first angled strut in the corresponding pair of angled struts to the surface of a second angled strut in the corresponding pair of angled struts, the surface of the first angled strut facing the first end of the frame and disposed on a first side of the free apex region, and the surface of the second angled strut facing the second end of the frame and disposed on an opposite second side of the free apex region.

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

5. A prosthetic heart valve according to any one of claims 1 to 4, 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 an axial side of the first row of first chambers.

6. A prosthetic heart valve according to claim 5, wherein the struts of the first portion of the second row of struts form pairs of angled struts, each of which is connected to a corresponding axially extending strut among the plurality of axially extending struts, wherein the struts of the second portion of the second row of struts form pairs of angled struts, each of which is connected to a corresponding free apex region among the plurality of apex regions, and wherein the plurality of free apex regions are not attached to the plurality of axially extending struts.

7. A prosthetic heart valve according to claim 5 or claim 6, wherein a portion of the plurality of axially extending struts are axially extending window struts that define a commissure window, the prosthetic heart valve further comprising a plurality of leaflets that are fixed together at adjacent sides thereof to form a commissure, and wherein the commissure is fixed to the commissure window of the frame.

8. A prosthetic heart valve according to any one of claims 1 to 7, wherein the first row of struts forms pairs of angled struts, wherein the struts in each pair of angled struts are connected together at their adjacent ends by an outflow apex region, and wherein the outflow apex region is bent between the pair of angled struts and has a narrowed width relative to the pair of angled struts.

9. The prosthetic heart valve of any one of claims 1 to 8, wherein a first axial length of each first pore in the first row of first pores is longer than a second axial length of each second pore in the second row of second pores.

10. A prosthetic heart valve according to any one of claims 1 to 9, wherein the frame further comprises a plurality of horizontal struts extending between adjacent second pores in the second row of second pores, and wherein each of the plurality of horizontal struts connects two adjacent struts in the second row of struts to two adjacent struts in the third row of struts.

11. A prosthetic heart valve according to any one of claims 1 to 10, further comprising a plurality of leaflets secured to the interior of the frame and configured to open and close to regulate the flow of blood from the second end of the frame through the prosthetic heart valve to the first end, 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 opens and closes 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 an outflow end of the frame and the second end is an inflow end of the frame.

13. A prosthetic heart valve according to any one of claims 1 to 12, further comprising an inner skirt sleeve disposed around the inner surface of the frame, wherein an outflow edge portion of the inner skirt sleeve is fixed to the second row of struts, and wherein at each free apex region, the outflow edge portion is disposed upstream of the free apex region.

14. A prosthetic heart valve comprising: A radially expandable and radially collapsible annular frame comprising a plurality of interconnected struts defining a plurality of rows of circumferentially extending cells disposed between an outflow end and an inflow end of the frame, wherein the plurality of interconnected struts comprises: a row of circumferentially extending first struts, the row of circumferentially extending first struts defining the outflow end, each first strut comprising two angled strut portions interconnected by an outflow apex region, wherein the outflow apex region bends between the two angled strut portions, and having a narrowed width relative to the width of the two angled strut portions; a plurality of axially extending struts spaced circumferentially about the frame and connected to the row of first struts; a row of circumferentially extending angled second struts disposed upstream of the row of first struts, wherein a first portion of the row of angled second struts are each directly connected to a corresponding axially extending strut of the plurality of axially extending struts, and wherein a second portion of the row of angled second struts form pairs of second struts connected together by free apex regions not attached to the plurality of axially extending struts, wherein the free apex regions of each corresponding pair of second struts have a first surface facing in a downstream direction and an opposite second surface facing in an upstream direction, wherein the first surface is curved between the corresponding pair of second struts, and wherein the second surface is recessed 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 the corresponding pair of second struts; as well as a row of circumferentially extending angled third struts, wherein the row of first struts, the axially extending struts, and the row of angled second struts form a first row of cells of the plurality of rows of cells disposed at the outflow end, wherein the row of angled second struts and the row of angled third 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 wider than a second width of each cell of the second row of cells; as well as A plurality of leaflets are secured within the interior of the frame and are configured to open and close to regulate the flow of blood from the inflow end of the frame through the prosthetic heart valve to the outflow end, wherein each free apex region of the row of angled second struts is positioned at the level of a portion of the plurality of leaflets that opens and closes during operation of the prosthetic heart valve.

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

16. A prosthetic heart valve according to claim 14 or claim 15, 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 with a convex curvature from one of the two angled strut portions located on a first side of the outflow apex region to the other of the two angled strut portions located 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 the second width.

18. A prosthetic heart valve comprising: A radially expandable and compressible annular frame comprising a plurality of interconnected struts defining a plurality of rows of circumferentially extending cells disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts comprising: a row of circumferentially extending outflow struts defining the outflow end, wherein each outflow strut comprises two angled strut portions interconnected by an apex region, wherein each apex region bends between a corresponding pair of the two angled strut portions and has a narrowed width and a length extending along at least 25% of the total length of the outflow strut, wherein the narrowed width is less than a width of the two angled strut portions; and A row of circumferentially extending angled first struts, the row of circumferentially extending angled first struts being disposed upstream of the row of outflow struts, wherein the row of outflow struts and the row of angled first struts at least partially form a first row of pores among the multiple rows of circumferentially extending pores disposed at the outflow end, and wherein a first width of each pore in the first row of pores is greater than a second width of pores in the remaining rows of pores among the multiple rows of circumferentially extending pores.

19. The prosthetic heart valve of claim 187, wherein the first width is twice the second width.

20. A prosthetic heart valve according to claim 18 or claim 19, wherein the plurality of interconnected struts further include a row of circumferentially extending angled second struts disposed upstream of the row of angled first struts, and wherein the row of angled first struts and the row of angled second struts form a second row of pores among the multiple rows of pores, the second row of pores being disposed adjacent to and upstream of the first row of pores, and wherein the second width of each pore in the second row of pores is half of the first width.

21. A prosthetic heart valve according to claim 20, wherein a portion of the first struts in the row of angled first struts form pairs of first struts, and the pairs of first struts are connected together by free apex regions that are not attached to other struts forming the first row of pore chambers, wherein the free apex regions of each corresponding pair of second struts have a first surface facing a downstream direction and an opposite second surface facing an upstream direction, wherein the first surface is curved between the corresponding pair of second struts, and wherein the second surface is recessed inwardly toward the first surface so that the width of the free apex region between the first surface and the second surface is less than the width of the corresponding pair of second struts.

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