Expandable prosthetic heart valve with flattened apices

Abstract

This invention discloses an artificial heart valve comprising a radially expandable and compressible annular frame. The frame includes a plurality of interconnecting struts defining multiple rows of units disposed between an inlet and an outlet end of the frame. The interconnecting struts include a plurality of outlet struts defining the outlet end and a plurality of inlet struts defining the inlet end. The frame further includes a plurality of apex regions formed at the inlet and outlet ends. Each apex region bends between two angled strut portions and forms one of the outlet struts or one of the inlet struts having the two angled strut portions. Each apex region has a narrowed width and a length extending at least 25% of the total length of one of the outlet struts or the inlet struts, the narrowed width being less than the width of one of the two angled strut portions.

Description

[Technical Field]

[0001] Cross-reference to related applications

[0002] This application claims the benefits of U.S. Provisional Patent Application No. 63 / 178,416, filed April 22, 2021; U.S. Provisional Patent Application No. 63 / 194,830, filed May 28, 2021; and U.S. Provisional Patent Application No. 63 / 279,096, filed November 13, 2021, all of which are incorporated herein by reference in their entirety. Field of Invention

[0003] This disclosure relates to an expandable artificial heart valve, including a frame with a narrowed and reduced-height apex region. [Previous Technology]

[0004] Background of the Invention

[0005] The human heart can be susceptible to various valvular diseases. These valvular diseases can lead to significant heart failure and ultimately require repair of the native valve or replacement with an artificial valve. Various known repair devices (e.g., stents) and artificial valves exist, as well as various known methods for implanting such devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various surgeries to deliver artificial medical devices to sites within the body that are not easily accessible by surgery or can be accessed without surgery. In a particular instance, an artificial heart valve may be mounted in a coiled state on the distal end of a delivery device and advanced via the patient's vascular structures (e.g., via the femoral and aortic arteries) until the artificial valve reaches the implantation site in the heart. The artificial valve then expands to its functional size, for example, by inflating a balloon on which the artificial valve is mounted, actuating a mechanical actuator that applies expansion force to the artificial valve, or by unfolding the sheath of the delivery device, allowing the artificial valve to expand to its functional size spontaneously.

[0006] Most expandable transcatheter heart valves comprise a radially expandable and compressible cylindrical metal frame and an artificial leaflet housed within the frame. The frame may comprise multiple circumferentially extending rows of angled struts defining open unit rows of the frame. At each of the inflow and outflow ends, the frame may comprise multiple apexes spaced apart from each other around the circumference of the frame, each apex forming a face between two angled struts (or strut portions) at the inflow or outflow end of the frame. In some cases, the artificial heart valve has a frame with angled struts forming acute angles at the apexes, thereby creating relatively high stress concentration at the apexes. Other artificial heart valves may have a frame with apexes having substantially vertical U-shaped portions connecting adjacent angled struts at each apex, thereby distributing stress across the angled struts and away from the apexes. However, such apex designs can increase the overall height of the frame (in the axial direction).

[0007] Another problem with the frame tip configuration described above includes the interaction between the exposed anterior or distal (e.g., inflow) tip and the delivery sheath that the inflatable balloon and / or delivery device passes through on its way to the implantation site. For example, in some cases, upon reaching the implantation site, the artificial heart valve may be pushed toward and over the balloon to the deployed position, causing the tip to rub against and / or abrade the balloon. In some cases, this can cause balloon degeneration, which can lead to underinflation at the implantation site. In other instances, during navigation through the vascular structure and through the delivery sheath that extends along a portion of the vascular structure to the implantation site, at the distal end (e.g., the inflow end) of the valve frame, a sharper or pointed tip may impinge on or penetrate the delivery sheath, thereby damaging the sheath and potentially the vascular structure.

[0008] Therefore, a modified frame design is needed for artificial heart valves. [Summary of the Invention]

[0009] Summary of the Invention

[0010] Examples of artificial heart valves comprising a radially expandable and compressible annular frame including multiple interconnected struts are described herein. The artificial heart valve may further include leaflet assemblies fastened to the frame. In some instances, the struts of the frame may define multiple rows of units disposed between the inflow and outflow ends of the frame. The outflow end may be defined by multiple outflow struts and the inflow end may be defined by multiple inflow struts. The frame may further include multiple apex regions that bend between two angled strut portions and form one of an inflow strut or an outflow strut having two angled strut portions. The apex regions may be assembled to be less damaging and have a lower height in the axial direction. For example, in some cases, the apex region may have a narrowed width (compared to the angled strut portion) extending a certain length in the circumferential direction. In other cases, the apex region (which may be alternatively referred to as the apex) may have a narrowed width and a central protrusion projecting outward from a thinned region of the apex.

[0011] In a representative example, the artificial heart valve includes a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining multiple rows of units disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts including a plurality of outflow struts defining an outflow end and a plurality of inflow struts defining an inflow end. Each outflow strut includes two angled strut portions interconnected by a apical region, and each inflow strut includes two angled strut portions interconnected by a apical region. Each apical region bends between a corresponding pair of two angled strut portions, wherein each apical region has a narrowed width and a length extending at least 25% of the total length of the outflow or inflow struts, and wherein the narrowed width is less than the width of the two angled strut portions.

[0012] In another representative example, the artificial heart valve includes: a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of units disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts including a plurality of outflow struts defining an outflow end and a plurality of inflow struts defining an inflow end. Each of the plurality of outflow struts and the plurality of inflow struts includes: two angled strut portions and a top region disposed between the two angled strut portions. The top region includes a curved axially outward surface forming a single curved surface between the axially outward surfaces of the two angled strut portions and an axially inwardly recessed curved outer surface from the axially inwardly recessed surface of the two angled strut portions toward the top region, such that the width of the top region is less than the width of the two angled strut portions.

[0013] In another representative example, the artificial heart valve includes: a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of units disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts including a plurality of outflow struts defining an outflow end and a plurality of inflow struts defining an inflow end. Each of the plurality of outflow struts and the plurality of inflow struts includes: two angled strut portions; and a apex region disposed between the two angled strut portions, the apex region including a apex and two thinned strut portions extending outward from the apex in opposite directions relative to the central longitudinal axis of the apex region. The width of the two thinned strut portions is less than the width of the two angled strut portions and the combined length of the two thinned strut portions is at least 25% of the length of the corresponding outflow strut or inflow strut including the apex region.

[0014] In another representative example, the artificial heart valve includes a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining multiple rows of units disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts including a plurality of outflow struts defining an outflow end and a plurality of inflow struts defining an inflow end. Each outflow strut includes two angled strut portions interconnected by a apical region, and each inflow strut includes two angled strut portions interconnected by a apical region. Each apical region bends between a corresponding pair of two angled strut portions, wherein each apical region has a narrowed width relative to the width of the two angled strut portions. Each apical region forms an angle greater than 120 degrees between the two angled strut portions.

[0015] In another representative example, the artificial heart valve comprises a radially expandable and compressible annular frame, including: a plurality of interconnected struts defining multiple rows of units disposed between an inflow and an outflow end of the frame, the plurality of interconnected struts including a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. Each outflow strut includes two angled strut portions interconnected by a apical region, and each inflow strut includes two angled strut portions interconnected by a apical region. Each apical region bends between a corresponding pair of two angled strut portions, and each apical region has a narrowed width relative to the width of the two angled strut portions. Each apical region is configured to plastically deform during the initial radial compression of the frame such that it becomes strain-hardened and the bending point of the frame shifts away from the apical region to the end of the angled strut portion during subsequent radial expansion.

[0016] In another representative example, the artificial heart valve includes a radially expandable and compressible annular frame comprising: a plurality of interconnecting struts defining a plurality of rows of units disposed between an inflow end and an outflow end of the frame, the plurality of rows of units including a first row of units disposed at the outflow end, the units in the first row of units having a greater axial length than the units in the remaining rows of units. The frame further includes a plurality of axial struts, each axial strut defining an axial side of two adjacent units in the first row of units and including: a central portion having a width greater than the width of the angled struts of the plurality of interconnecting struts; and an upper portion and a lower portion disposed at opposite ends of the central portion, each wider than the width of the central portion.

[0017] In another representative example, the artificial heart valve includes a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of units disposed between an inflow end and an outflow end of the frame; the plurality of interconnected struts including a plurality of outflow struts defining an outflow end and a plurality of inflow struts defining an inflow end. Each of the plurality of outflow struts and the plurality of inflow struts includes two angled strut portions and a tip disposed between the two angled strut portions, the tip having an axially facing inner surface, including two recesses recessed into the inner surface and a central protrusion disposed between the two recesses and a protrusion away from the two recesses. The two recesses form a thinned region of the tip, the width of which is less than the width of the two angled strut portions.

[0018] In another representative example, the artificial heart valve includes a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of units disposed between a first end and a second end of the frame, the plurality of interconnected struts including a plurality of first struts defining the first end and a plurality of second struts defining the second end, wherein each first strut includes two angled strut portions interconnected by apexes. At the first end, each of one or more apexes bends between a corresponding pair of two angled strut portions, has a narrowed width relative to the width of the two angled strut portions, and includes a central protrusion axially projecting inward from the apex.

[0019] In another representative example, the artificial heart valve includes a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of units disposed between an inflow and an outflow end of the frame, the plurality of rows of units including a first row of units disposed at the outflow end and a plurality of axial struts. Each axial strut defines the axial side of two adjacent units in the first row of units and has a width greater than the width of the angled struts of the plurality of interconnected struts. Each axial strut includes one or more slits disposed along the length of the axial strut, the one or more slits extending through a portion of the width of the axial strut.

[0020] In another representative example, the artificial heart valve includes a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of units disposed between an inlet and an outlet end of the frame, the plurality of rows of units including a first row of units disposed at the outlet end and a plurality of axial struts, each axial strut defining an axial side of two adjacent units in the first row of units and having a width greater than the width of the angled struts of the plurality of interconnected struts. Each axial strut includes a plurality of slits spaced apart from each other along the length of the axial strut, each of the plurality of slits extending through a portion of the width of the axial strut.

[0021] In another representative example, the artificial heart valve includes a radially expandable and compressible frame comprising: a plurality of interconnected struts defining a plurality of rows of units disposed between a first end and a second end of the frame, the plurality of interconnected struts including a plurality of first struts defining the first end and a plurality of second struts defining the second end. Each first strut includes two angled strut portions; and a tip region disposed between the two angled strut portions, the tip region being curved between the two angled strut portions and having a narrowed width relative to the width of the two angled strut portions. The artificial heart valve further includes a covering element surrounding and covering the tip region of the frame.

[0022] In another representative example, the artificial heart valve includes a radially expandable and compressible annular frame comprising: a plurality of interconnecting struts defining a plurality of rows of units disposed between an inflow end and an outflow end of the frame, the plurality of interconnecting struts including a plurality of outflow struts defining an outflow end and a plurality of inflow struts defining an inflow end. Each of the plurality of inflow struts includes two angled strut portions; and a top region disposed between the two angled strut portions, the top region including a curved axially outward surface forming a single curved surface between the axially outward surfaces of the two angled strut portions and an axially inwardly recessed curved outer surface of the top region concave from the axially inwardly facing surfaces of the two angled strut portions toward the top region, such that the width of the top region is less than the width of the two angled strut portions and a shoulder is formed at either end of the top region where the smaller width of the top region transitions to the width of the two angled strut portions. The artificial heart valve further includes a covering element comprising a plurality of loops that surrounds and covers at least a portion of the top region of the frame between the shoulders of the top region.

[0023] In another representative example, the artificial heart valve includes a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of units disposed between a first end and a second end of the frame, the plurality of interconnected struts including a plurality of first struts defining the first end and a plurality of second struts defining the second end, wherein each of the plurality of first struts includes a apex region; and a side edge disposed around an inner or outer surface of the frame and coupled to the frame. The side edge includes a first edge extending circumferentially around the side edge and connected to the first end of the frame; and a plurality of axially extending valves extending from the first edge and spaced apart from each other, each of the plurality of axially extending valves surrounding a corresponding apex region such that the apex region is covered.

[0024] The various innovations disclosed herein can be used in combination or individually. This disclosure is provided to introduce, in a simplified form, the concepts further described below in the embodiments. This disclosure is not intended to identify key or basic morphological features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. The foregoing and other objectives, morphological features, and advantages of this disclosure will become more apparent from the following embodiments, the claims, and the accompanying drawings.

Implementation Method

[0064] Detailed Description of Preferred Embodiments: General Considerations

[0065] For the purposes of this description, certain aspects, advantages, and novel morphologies of examples of this disclosure are described herein. The methods, systems, and apparatus described should not be construed as limiting in any way. In fact, this disclosure relates individually and in various combinations and sub-combinations to all novel and non-obvious morphologies and forms of the various disclosed examples. The disclosed methods, systems, and apparatus are not limited to any particular morphology, form, or combination thereof, nor are they required to possess any particular advantage or problem-solving capability.

[0066] Although some operations in the disclosed examples are described in a specific sequential order for ease of presentation, it should be understood that this manner of description encompasses reconfiguration unless the specific language described below requires a particular order. For example, sequentially described operations may be reconfigured or performed concurrently in some cases. Furthermore, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be combined with other methods. Additionally, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation, and those generally skilled in the art can easily identify these operations.

[0067] Unless the context clearly specifies otherwise, as used in this application and the claims, the singular forms "a / an" and "the" include the plural forms. Additionally, the term "comprising" means "including". Furthermore, the term "coupled" generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or connected, and does not exclude the presence of intermediate elements between coupled or associated items in the absence of a specific opposite language.

[0068] As used herein, the term "proximal" refers to the position, orientation, or portion of the device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to the position, orientation, or portion of the device that is further away from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., away from the patient's body), while distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). Unless otherwise explicitly defined, the terms "longitudinal" and "axial" refer to axes extending in the proximal and distal directions. Examples of the disclosed technology

[0069] Examples of radially expandable and compressible artificial heart valves comprising a ring-shaped frame are described herein. The artificial heart valve may further comprise a plurality of leaflets attached to the frame. In some instances, the leaflets may be attached to the frame via commissures formed by adjoining adjacent ends of the leaflets (e.g., commissural flaps).

[0070] In some instances, the frame of the artificial heart valve may include multiple rows of units formed by interconnecting struts of the frame. The multiple rows of units may include a first row of units disposed at the outflow end of the frame. In some instances, the units in the first row of units are elongated in the axial direction relative to the units in the remaining rows of units of the frame.

[0071] At each of the inflow and outflow ends, the frame may include a plurality of top regions spaced apart from each other around the circumference of the frame, each top region forming a joint between two angled support portions at the inflow or outflow end of the frame. For example, the two angled support portions and the corresponding top regions may together form an outflow support at the outflow end of the frame or an inflow support at the inflow end of the frame. Each top region may be curved between the corresponding two angled support portions and have a width less than the width of the two angled support portions (in the direction perpendicular to the curve of the top region).

[0072] In some instances, the top region may have a length of at least 25% of the length of the corresponding outflow or inflow support. Furthermore, in some instances, the top region may have a larger radius of curvature and define a larger angle (e.g., between 120 and 140 degrees) between two angled support portions, compared to more conventional tops with a sharper or U-shape. This allows the top region to have a relatively smaller total height defined in the axial direction (e.g., equal to or less than the width of the top region than the width of the angled support portion).

[0073] In some instances, the top region may contain two curved internal recesses separated from each other by micro-sized bumps.

[0074] In this manner, the relatively small height of the tip region allows the unit at the outflow end of the frame to have a longer axial length, thereby creating more open space at the outflow end of the unit for blood flow and coronary artery access. In addition, the tip region configuration described above can provide more non-invasive tip regions at both the outflow and inflow ends of the frame, thereby reducing the interaction between the tip region and the balloon of the delivery device and / or delivery sheath.

[0075] In addition, in some instances, a buffer or covering element may cover at least a portion of the tip or tip region at the end of the frame and / or wrap around at least a portion of the tip or tip region, thereby providing even more non-traumatic tip region or tip during navigation of the radially compressed artificial heart valve via the delivery device to the implantation site and possibly reducing thrust via the delivery sheath.

[0076] The artificial valve disclosed herein can be radially compressed and expanded between a radially compressed state and a radially expanded state. Therefore, the artificial valve can be coiled in a radially compressed state on or held by the implantation delivery device during delivery, and then expanded to a radially expanded state after the artificial valve reaches the implantation site. It should be understood that the artificial valve disclosed herein can be used with a variety of implantation delivery devices and can be implanted via a variety of delivery procedures, examples of which will be discussed in more detail later.

[0077] Figure 1 illustrates an artificial heart valve 10 according to one example. Any of the artificial valves disclosed herein is suitable for implantation in the native aortic annulus, but in other examples, it may be suitable for implantation in other native valve annulus of the heart (e.g., lung, mitral, and tricuspid valves). The disclosed artificial valves may also be implanted in blood vessels communicating with the heart, including the pulmonary artery (for replacing the function of a diseased pulmonary valve) or the superior or inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries, and vessels of the patient. The disclosed artificial valves may also be implanted in a valve-in-valve procedure within a previously implanted artificial valve (which may be an artificial surgical valve or an artificial transcatheter heart valve).

[0078] In some instances, the disclosed artificial valve can be implanted within a docking or anchoring device implanted within a native heart valve or blood vessel. For example, in one instance, the disclosed artificial valve can be implanted within a docking device implanted within a pulmonary artery to replace the function of a diseased lung valve, as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another instance, the disclosed artificial valve can be implanted within a docking device implanted within or at the native mitral valve, as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In yet another instance, the disclosed artificial valve can be implanted within a docking device implanted within a superior or inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed in U.S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0079] The artificial valve 10 may have four main components: a stent or frame 12, a valve structure 14, a medial edge 16, and a perivascular external sealing component or lateral edge 18. The artificial valve 10 may have an inflow portion 15, a middle portion 17, and an outflow portion 19. The medial edge 16 may be disposed on and / or coupled to the inner surface of the frame 12, while the lateral edge 18 may be disposed on and / or coupled to the outer surface of the frame 12.

[0080] Valve structure 14 may include three leaflets 40 that collectively form a leaflet structure, which may be configured to collapse in a tricuspid valve configuration, but in other instances, a larger or fewer number of leaflets (e.g., one or more leaflets 40) may be present. The leaflets 40 may be fastened to each other on their adjacent sides to form a commissure 22 of leaflet structure 14. The lower edge of valve structure 14 may have a wavy, fan-shaped shape and may be fastened to the medial edge 16 by sutures (not shown). In some instances, the leaflets 40 may be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials known in the art and described in U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0081] The frame 12 may be radially compressible (collapseable) and expandable (e.g., the expandable configuration shown in FIG. 1) and includes a plurality of interconnecting pillars 24. A plurality of circumferentially spaced tips 26 are formed at the inflow portion 15 and the outflow portion 19 of the frame 12 (only the tips 26 at the outflow portion 19 are visible in FIG. 1). Each tip 26 is formed at the interface between two angled pillars 24 at the inflow portion 15 or the outflow portion 19. FIG. 1 depicts a known frame design with tips 26 forming a U-shaped bend between two angled pillars 24. In some instances, the angle 30 between the two angled pillars 24 connected at the tip 26 may be in the range of 90 to 120 degrees.

[0082] The frame 12 may be formed with a plurality of circumferentially spaced slots, or adapted to mount the fusion 22 of the valve structure 14 to the fusion window 20 of the frame. The frame 12 may be made of any of a variety of suitable malleable expandable materials (e.g., stainless steel) or self-expanding materials (e.g., Nitinol). When constructed of malleable expandable materials, the frame 12 (and therefore the artificial valve 10) can be rolled into a radially collapsed configuration on the delivery catheter or device, and then expanded inside the patient by an inflatable balloon or equivalent expansion mechanism. When constructed of expandable materials, the frame 12 (and therefore the artificial valve 10) can be rolled into a radially collapsed configuration and confined in the collapsed configuration by insertion into an equivalent mechanism of the sheath or delivery catheter. Once inside the body, the artificial valve can be advanced from the delivery sheath, which allows the artificial valve to expand to its functional size.

[0083] Suitable malleable and expandable materials that can be used to form the frame 12 include, but are not limited to, stainless steel, biocompatible materials, high-strength alloys (e.g., cobalt-chromium or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In a particular example, the frame 12 is made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N® alloy (SPS Technology, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (covered by ASTM F562-02). The MP35N® alloy / UNS R30035 alloy contains 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. Additional details regarding the artificial valve 10 and its various components are described in WIPO Patent Application Publication No. WO 2018 / 222799, which is incorporated herein by reference.

[0084] Figure 2 illustrates a delivery device 100 according to an example, which can be used to implant an expandable artificial heart valve (e.g., the artificial heart valve 10 of Figure 1 or any of the other artificial heart valves described herein). In some examples, the delivery device 100 is specifically adapted for introducing the artificial valve into the heart.

[0085] In the example illustrated in Figure 2, the delivery device 100 is a balloon catheter, which includes a handle 102 and a steerable outer shaft 104 extending distally from the handle 102. The delivery device 100 may further include an intermediate shaft 106 (which may also be referred to as a balloon shaft) extending proximally and distally from the handle 102, the portion extending distally from the handle 102 also coaxially extending through the outer shaft 104. In addition, the delivery device 100 may further include an inner shaft 108 extending distally from the handle 102 coaxially through the intermediate shaft 106 and the outer shaft 104, and extending proximally from the handle 102 coaxially through the intermediate shaft 106.

[0086] The outer shaft 104 and the intermediate shaft 106 can be assembled to longitudinally translate (e.g., move) relative to each other along the central longitudinal axis 120 of the delivery device 100 to facilitate delivery and positioning of the artificial valve at the implantation site in the patient's body.

[0087] The intermediate shaft 106 may include a proximal portion 110 extending from the proximal end of the handle 102 to the proximal end of the connector 112. A rotatable knob 114 may be mounted on the proximal portion 110 and may be assembled to allow the intermediate shaft 106 to rotate about a central longitudinal axis 120 and relative to the outer shaft 104.

[0088] The connector 112 may include a first port 138 configured to receive a guide wire passing through it and a second port 140 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 140 may be fluidly coupled to the interior of the intermediate shaft 106.

[0089] The intermediate shaft 106 may further include a distal portion that extends distally beyond the distal end of the outer shaft 104 when the distal end of the outer shaft 104 is positioned away from the inflatable bladder 118 of the conveying device 100. The distal portion of the inner shaft 108 may extend distally beyond the distal portion of the intermediate shaft 106.

[0090] The balloon 118 can be coupled to the distal portion of the intermediate shaft 106.

[0091] In some instances, the distal end of balloon 118 may be coupled to the distal end of delivery device 100, such as to an anterior cone 122 (as shown in FIG. 2) or an alternative component (e.g., distal shoulder) at the distal end of delivery device 100. The intermediate portion of balloon 118 may overlay the valve mounting portion 124 of the distal portion of delivery device 100, and the distal portion of balloon 118 may overlay the distal shoulder 126 of delivery device 100. The valve mounting portion 124 and the intermediate portion of balloon 118 may be assembled to accommodate an artificial heart valve in a radially compressed state. For example, as schematically shown in FIG. 2, an artificial heart valve 150 (which may be one of the artificial valves described herein) may be mounted around balloon 118 at the valve mounting portion 124 of delivery device 100.

[0092] The balloon shoulder assembly, including the distal shoulder 126, is assembled to maintain the artificial heart valve 150 (or other medical device) in a fixed position on the balloon 118 during delivery via the patient's vascular structures.

[0093] The outer shaft 104 may include a distal tip portion 128 mounted on its distal end. The outer shaft 104 and the intermediate shaft 106 may be axially translated relative to each other to position the distal tip portion 128 proximally to the valve mounting portion 124 when the artificial valve 150 is mounted in a radially compressed state on the valve mounting portion 124 (as shown in FIG. 2) and during delivery of the artificial valve to the target implantation site. Thus, when the distal tip portion 128 is positioned proximally to the valve mounting portion 124, the distal tip portion 128 may be configured to prevent the artificial valve 150 from moving proximally relative to the balloon 118 in the axial direction relative to the balloon 118.

[0094] The annular space is defined between the outer surface of the inner shaft 108 and the inner surface of the intermediate shaft 106 and can be assembled to receive fluid from a fluid source via the second port 140 of the connector 112. The annular space is fluidly coupled to a fluid passage formed between the outer surface of the distal portion of the inner shaft 108 and the inner surface of the balloon 118. Thus, fluid from the fluid source can flow from the annular space to the fluid passage to inflate and radially expand the balloon 118 and deploy the artificial valve 150.

[0095] The inner cavity of the inner shaft can be assembled to accommodate a guide wire passing through it for navigating the distal portion of the delivery device 100 to the target implantation site.

[0096] Handle 102 may include a steering mechanism configured to adjust the curvature of the distal portion of the conveyor 100. In the illustrated example, for example, handle 102 includes an adjustment element, such as the illustrated rotatable knob 160, which is then operatively coupled to the proximal portion of the pull cable. The pull cable may extend distally from handle 102 through the outer shaft 104 and has a distal portion attached to the outer shaft 104 at or near its distal end. Rotating knob 160 increases or decreases the tension in the pull cable, thereby adjusting the curvature of the distal portion of the conveyor 100. Further details of the steering or deflection mechanism of the conveyor can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0097] The handle 102 may further include an adjustment mechanism 161 comprising an adjustment component such as the illustrated rotatable knob 162, and an associated locking mechanism comprising another adjustment component configured as a rotatable knob 178. The adjustment mechanism 161 is configured to adjust the axial position of the intermediate shaft 106 relative to the outer shaft 104 (e.g., for fine positioning at the implantation site). Further details regarding the delivery device 100 can be found in U.S. Provisional Applications Nos. 63 / 069,567 and 63 / 138,890, which are incorporated herein by reference.

[0098] Figure 3 shows an example of an artificial heart valve 200 comprising a radially expandable and compressible annular frame 202 and a plurality of leaflets 204 fastened to the frame. Each leaflet 204 may include opposing commissural flaps disposed on opposite sides of the leaflet 204 and a valve tip edge portion extending between the opposing commissural flaps.

[0099] The frame 202 may be made of any of the various suitable malleable expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloys (NiTi), such as nickel-titanium metals). In some instances, the frame 202 comprises malleable expandable materials, such as those described above with reference to FIG1 for the artificial heart valve 10.

[0100] The frame 202 may include a plurality of interconnecting pillars 206 forming multiple rows of open units 208 between the outflow end 210 and the inflow end 212 of the frame 202. In some instances, as shown in FIG3, the frame 202 may include three rows of units 208, wherein a first (e.g., the upper row in FIG3) row of units 214 is disposed at the outflow end 210 and has units 208 that are elongated in the axial direction (relative to the central longitudinal axis 216 of the frame 202) compared to the units 208 in the remaining rows of units. For example, the units 208 in the first row of units 214 may have a longer axial length defined in the direction of the central longitudinal axis 216 of the frame 202 compared to the units 208 in the remaining rows of units (e.g., the units in that row of units at the inflow end 212).

[0101] In some instances, as shown in Figure 3, each column of cells 208 contains nine cells. Therefore, in such instances, frame 202 may be referred to as a nine-cell frame.

[0102] In other instances, frame 202 may contain more than three columns of cells (e.g., four or five columns) and / or more or fewer than nine cells per column. In some instances, cells 208 in the first column of cells 214 may not be elongated compared to cells 208 in the remaining columns of frame 202.

[0103] The interconnecting pillars 206 may include a plurality of angled pillars 218, 234, 236, and 238 arranged in a plurality of columns extending circumferentially as angled pillars, wherein such columns are arranged along the length of the frame between the outflow end 210 and the inflow end 212 of the frame 202. For example, the frame 202 may include a first column of angled pillars 238 arranged end-to-end and extending circumferentially at the inflow end 212 of the frame; a second column of angled pillars 236 extending circumferentially; a third column of angled pillars 234 extending circumferentially; and a fourth column of angled pillars 218 extending circumferentially at the outflow end 210 of the frame 12. The fourth column of angled pillars 218 may be connected to the third column of angled pillars 234 by a plurality of axially extending window pillar portions 240 and a plurality of axial (e.g., axially extending) pillars 232. The axially extending window support portion 240 defines a connecting window (e.g., an open window) 242, which is circumferentially spaced from each other around the frame 202 and adapted to accommodate a pair of connecting tabulae of one pair of adjacent leaflets 204 disposed in the connecting 230.

[0104] One or more (e.g., two, as shown in FIG3) axial struts 232 may be circumferentially positioned between two joined windows 242 formed by the window strut portions 240. Since each column of frame 202 may include fewer units (e.g., nine) and fewer axial struts 232 may be included between each joined window 242, each unit 208 may have an increased width (in the circumferential direction) compared to other artificial heart valves, such as the artificial heart valve 10 of FIG1, thereby providing a larger opening for blood flow and / or coronary artery access, as described herein.

[0105] Each axial pillar 232 and each window pillar portion 240 extends from a position defined by the convergence of the lower ends of two angled pillars 218 (which may also be referred to as upper pillar joints or upper elongated pillar joints) (e.g., the end configured to be inside the outlet end 210 and furthest from the outlet end) to another position defined by the convergence of the upper ends of two angled pillars 234 (which may also be referred to as lower pillar joints or lower elongated pillar joints) (e.g., the end configured closer to the outlet end 210). Each axial pillar 232 and each window pillar portion 240 forms the axial side of two adjacent units in the first row of units 214.

[0106] In some instances, as shown in FIG3, each axial strut 232 may have a width 244 greater than the width of the angled struts 218, 234, 236 and / or 238. As used herein, the “width” of a strut is measured between relative positions on opposite surfaces of the strut extending radially between its inner and outer surfaces (relative to the central longitudinal axis 216 of frame 200). The “thickness” of a strut is measured between relative positions on its inner and outer surfaces and perpendicular to the width of the strut. In some instances, the width 244 of the axial strut 232 is 50 to 200%, 75 to 150%, or at least 100% (e.g., twice) greater than the width of the angled struts of frame 202. For example, if the angled struts 218, 234, 236, and 238 are approximately 0.3 mm, then the width 244 of the axial strut 232 can be in the range of 0.45 mm to 0.9 mm, 0.5 mm to 0.75 mm, or at least 0.6 mm. In some instances, the width 244 of the axial strut 232 can be in the range of 0.5 mm to 1.0 mm.

[0107] For example, in known artificial heart valves (such as valve 10 shown in Figure 1), the axial strut has the same width as the other struts of the frame (e.g., angled struts). However, when implanted and during use, as the leaflets of the artificial heart valve press against the frame during the systolic phase, the leaflets may bend radially outward through the unit opening due to the relatively narrow width of the axial strut. This phenomenon can reduce the long-term durability of the leaflets, especially when the upper (e.g., outflowing) edge of the leaflet is pushed against and bent by the axial strut, as described above.

[0108] Therefore, by providing a width 244 to the axial support 232 that is greater than the width of the other angled supports of the frame 202, a larger contact area is provided when the leaflet 204 contacts the wider axial support 232 during contraction, thereby distributing stress and reducing the extent to which the leaflet 204 can fold radially outward through the unit 208 above the axial support 232. Thus, the long-term durability of the leaflet 204 can be improved.

[0109] In some cases, at the outflow end 228 of the leaflet 204, the free edge may press against the axial support 232 at its outflow (e.g., upper) end portion 246. However, such outflow end portion 246 may be even wider than the width 244 (as shown in FIG3), thereby providing the leaflet 204 with an even larger contact area and support.

[0110] As described above, since the frame 202 may have fewer units in the circumferential direction (e.g., nine in Figure 3), each unit 208 may have an increased width (measured in the circumferential direction) compared to the artificial valve of Figure 1. This increased width of the units 208 in the first row of units 214 allows the wider axial struts 232 to be incorporated into the frame 202 without sacrificing the open space for blood flow and / or coronary artery access.

[0111] The syndesmotic flaps of adjacent leaflets 204 can be fastened together to form a syndesm 230. Each syndesm 230 of the artificial heart valve 200 includes two syndesmotic flaps paired together, one syndesmotic flap originating from each of the two adjacent leaflets 204 and extending through the syndesmotic window 242 of the frame 202. Each syndesm 230 can be fastened to the window strut portion 240 forming the syndesmotic window 242.

[0112] The tip edge portion (e.g., fan-shaped edge) of each leaflet 204 can be fastened to the frame via one or more fasteners (e.g., sutures). In some instances, as shown in FIG3, the tip edge portion of each leaflet 204 can be directly fastened to the struts (e.g., angled struts 234, 236, and 238) of the frame 202. For example, the tip edge portion of the leaflet 204 can be sutured to the angled struts 234, 236, and 238, which generally follow the contour of the tip edge portion of the leaflet.

[0113] In some instances, the leaflet 204 can be fastened to the inner edge and the inner edge can then be directly fastened to the frame 202.

[0114] In addition, in some instances, the outer edge may be connected to the outer surface of the frame 202 (e.g., similar to the outer edge 18 of the valve 10 in FIG1).

[0115] As shown in Figure 3, in some instances, one or more of the axial struts 232, or each of them, may include an inflow portion (e.g., an inflow portion closer to the inflow end than the outflow portion 246) 248, which is widened relative to the intermediate portion 247 of the axial strut 232 (which may be defined by width 244), similar to the outflow portion 246 (as described above). In some instances, the inflow portion 248 of the axial strut 232 may include an aperture 249. The aperture 249 may be configured to receive fasteners (e.g., sutures) for attaching the soft components of the artificial heart valve 200 to the frame 202. For example, in some cases, the outer edge may be positioned around the outer surface of the frame 202 and secured to the aperture 249 (e.g., as shown in Figure 13 and further described below).

[0116] The frame 202 may further include a plurality of tips 220 formed at the inflow end 212 and the outflow end 210, each tip 220 forming a joint between two angled supports 218 at the inflow end 212 or the outflow end 210. Thus, the tips 220 are circumferentially spaced apart from each other at the inflow end 212 and the outflow end 210. As shown in FIG3, each tip 220 may have a side portion 222 that curves outward from the angled support 218 to which it is connected and an end portion 224 extending between the two side portions 222 of the tip 220. The side portions 222 may extend in a direction parallel to the central longitudinal axis 216. The end portions 224 may be relatively flat and include a surface disposed perpendicular to the central longitudinal axis 216. Each tip 220 may have two bends at its distal portion 224 and two bends at its lateral portion 222 (e.g., one bend at the interface between each lateral portion 222 and the angled strut 218). In this way, the tip 220 may be U-shaped, similar to the tip 26 of the valve in FIG1.

[0117] Although the tip 220 of this shape can distribute stress across the angled strut 218 to which it is connected, this shape results in the height (in the axial direction) 221 of the tip 220 being added to the total height of the artificial heart valve 200 at the inlet 212 and outlet 210. Therefore, the inlet 226 of the leaflet 204 is spaced apart from the inlet 212 of the frame 202. This, in turn, allows the outlet 228 of the leaflet 204 to be positioned closer to the outlet 210 of the frame, thereby leaving a smaller open space in the unit 208 of the upper row of units 214 between the outlet edge of the leaflet and the struts 218 of the upper row. In some instances, this configuration can cause the leaflet 204, including the commissure 230 of the adjacent commissural flap of the leaflet 204, to at least partially block blood flow into the coronary ostium. Furthermore, it can inhibit the coronary re-entry device from passing through such a small space.

[0118] Figure 4 shows an artificial heart valve 200 radially compressed onto and around a portion of the distal portion of a delivery device 250 (which may be identical to or similar to delivery device 100 of Figure 2). As shown in Figure 4, the artificial heart valve 200 is radially compressed around a portion of an inflatable balloon 252 of the delivery device 250 (the inflatable balloon 252 may be similar to balloon 118 of Figure 2). In some instances, as shown in Figure 4, the artificial heart valve 200 may be rolled up onto the distal portion of the delivery device 250 with the inflow end 212 facing the anterior cone 254 of the delivery device 250. In other instances, the artificial heart valve 200 may be rolled up onto the distal portion of the delivery device 250 with the outflow end 210 facing the anterior cone 254.

[0119] In this configuration, at least the tip 220 at the inlet end 212 is exposed, which can cause wear on the tip 220 or penetration of the tip 220 into the inner wall of the delivery sheath through which the delivery device 250 passes to the implantation site (e.g., during delivery of the artificial heart valve 200 to the target implantation site). For example, during implantation surgery when the artificial heart valve 200 is radially compressed (e.g., coiled) around the delivery device 250, the artificial heart valve 200 may be pushed through the inner lumen of the delivery sheath and the tip 220 may contact, perforate, or tear the wall of the delivery sheath.

[0120] In some instances, the exposed tip 220 may interact with the balloon 252. For example, if the artificial heart valve 200 curls away from the inflatable portion of the balloon 252, as the artificial heart valve 200 is pushed over the inflatable portion of the balloon 252, upon reaching the implantation site, the flow into the tip 220 may interact with the balloon 252 (e.g., scrape or resist the movement of the valve over the balloon).

[0121] To address the aforementioned problems with the addition of height to the inlet and outlet ends of the artificial heart valve, the frame of the artificial heart valve may actually have a tip or tip region at the inlet or outlet end of the frame that forms a large angle and has a large radius of curvature between the angled struts (or portions of the angled struts), thereby creating a more curved or flatter shape (e.g., a smaller acute angle, such as the U-shaped design shown in Figures 1 and 3) that may cause less damage to the balloon and delivery sheath of the delivery device. Furthermore, as explained further below, such a tip region can create a smaller axial height at the inlet and outlet ends of the artificial heart valve, thereby allowing the inlet end of the leaflet (e.g., the inlet end of the leaflet tip edge portion) to be positioned closer to the inlet end of the frame, and thus creating a larger open space at the outlet end of the artificial heart valve for increased blood flow and coronary artery access.

[0122] Figure 5 shows an exemplary frame 300 for an artificial heart valve, which includes interconnected struts 302 forming apex (or apex region) 304 at the inlet end 306 and outlet end 308 of the frame 300. As shown in the enlarged view of a portion of the frame 300 in Figures 5 and 6, each apex 304 is positioned at the inlet end 306 or outlet end 308 of the frame 300 between two angled struts 310 (similar to the angled struts 218 and 238 of the frame 202 in Figure 3) and forms a transition area between the two angled struts.

[0123] Compared to the tip 220 in FIG. 3, each tip 304 may have a flatter (e.g., less pointed) shape. For example, each tip 304 may include a curved or relatively flat outer surface 312 and an arcuate or curved recess 314 (FIG. 6) disposed opposite the outer surface 312. The recess 314 forms a thinned region at the tip 304, having a width 316 smaller than the width 318 of the angled strut 310 (FIG. 6). This thinned region of the tip 304 may be located away from the tip and across the angled strut 310 extending from either side of the tip 304, thus distributing the stress experienced by the frame 300.

[0124] Each apex 304 of frame 300 (Figures 5 and 6) may have a reduced height compared to each apex 220 of frame 202 (Figure 3). For example, Figure 3 shows a height difference 322 between the inflow end 212 of frame 202 (at apex 220) and the inflow end 306 of frame 300, due to the flatter apex 304 of frame 300. Therefore, the inflow end 226 of leaflet 204 may be positioned closer to the inflow end 306 of frame 300 than it is in frame 202. In some instances, for the same overall valve height of frame 300 and frame 202, this allows the units of frame 300, specifically the first row of units 324 positioned at or near the outflow end 308, to extend axially. For example, in some cases, the axial height 326 (FIG. 5) of the first row unit 324 can be approximately twice the height 221 (FIG. 3) of the height of the more U-shaped and axially oriented apex 220 of the frame 202, compared to the axial height of the first row unit 214 of the frame 202. These "higher" or longer first row units 324 of the frame 300 can have a larger portion exposed above the outflow end of the leaflet, thereby creating a larger open space for blood flow at the outflow end of the frame 300 and reducing the risk of sinus septum.

[0125] In some instances, as shown in FIG6, the angle (e.g., apex angle) 320 between the two angled supports 310 connected at the top 304 may be greater than 120 degrees. In some instances, the angle 320 may be in the range of 120 degrees (excluding the endpoints) to 140 degrees (e.g., such that the angle 320 is greater than 120 degrees). In some instances, the angle 320 may be in the range of 135 to 140 degrees, 138 to 140 degrees, or 139 to 140 degrees. In some instances, the angle 320 may be approximately 140 degrees (e.g., ±1 degree).

[0126] In some instances, the balloon-expandable valve comprising the frame 300 is radially expandable and deployed at the target implantation site by inflating a balloon of a delivery device around which the artificial heart valve is mounted (e.g., a delivery device such as that in Figure 2). After such deployment, due to a small amount of inherent elasticity in the metal forming the frame 300, the frame tends to bounce radially inward (towards the central longitudinal axis of the frame) back to the expansion diameter, which is slightly smaller than the diameter defined by the inflatable balloon (of the delivery device), once the balloon has deflated and no longer exerts a radially outward force on the frame 300. When radially expanding over the inflatable balloon, such radial bounce may be required to be within 5% of the diameter of the artificial heart valve. Reducing the radial bounce from the diameter of the valve over the inflatable balloon to the diameter of the valve after the balloon has deflated provides better predictability of the final expansion diameter of the valve.

[0127] The angle 320 at the apex 304 can affect the degree of rebound of the frame 300 after the artificial heart valve frame is radially expanded by inflating and deflating the balloon. For example, a larger apex angle (e.g., greater than 120 degrees and at most 140 degrees) can cause a smaller degree of radial rebound compared to a smaller apex angle (e.g., between 90 degrees and 120 degrees).

[0128] The apex 304 of the angle 320, which is created between the angled struts 310 within the range described above (e.g., greater than 120 degrees and at most 140 degrees), can cause radial rebound in the range of 0.3 to 0.4 mm at the inlet end 306 and the outlet end 308 for an artificial valve having an expansion working diameter of 20 mm. This is less than half of the radial rebound that may be experienced at the middle portion of the valve (e.g., in the range of 0.95 to 0.97 mm). The radial rebound at the inlet end 306 and the outlet end 308 of the frame 202 can also be significantly less than the radial rebound of valves with a more conventional apex and an apex angle of 120 degrees or less (e.g., valve 10 of FIG. 1), which can be in the range of 0.7 to 0.8 mm.

[0129] Advantageously, as described above, the configuration of the tip 304 allows the apex angle 320 to be enlarged beyond the angle of a conventional U-shaped apex angle, thereby reducing the degree of radial springback of the frame 300. Furthermore, the increased angle and shape of the tip 304 (e.g., reduced height and curved or bow-shaped shape, as described above) provide a less damaged tip 304 (compared to a sharper and / or U-shaped tip, such as those shown in Figures 1 and 3). Therefore, the risk of the tip 304 interacting with the inflatable bladder and native anatomy of the delivery sheath and / or delivery device, and / or the deterioration of the inflatable bladder and native anatomy of the delivery sheath and / or delivery device, is reduced.

[0130] Apart from the configuration of the top 304, the frame 300 may be similar to the frame 202 of FIG3. For example, the frame 300 may include a first column unit 324 defined by the angled pillar 310 at the outlet 308, angled pillar 234, window pillar portion 240, and axial pillar 232.

[0131] In some instances, as shown in Figures 5 and 6, one or more of the axial struts 232 may have an increased width 244, as described above with reference to Figure 3. Furthermore, one or more of the axial struts 232 may include an aperture 249 in the inflow portion 248.

[0132] In some instances, instead of being centered along the window support portion 240 and between two adjacent units in the upper column unit 324 (e.g., as shown in FIG. 5), the connecting window 342 may be positioned along the lower portion of the axial support forming the axial side of the two adjacent units in the first column unit 324, as shown in FIG. 7. In other words, the connecting window 342 may be spaced apart from the outlet end 308 of the frame 300 and spaced apart towards the lower portion of the two adjacent units in the first column unit 324.

[0133] For example, FIG. 7 shows a portion of an example of a frame 300 including a combined window 342 lowered (compared to the combined window 242 shown in FIG. 5) within the first column unit 324. The combined window 342 is formed and defined between a first axially extending window pillar portion 340a and a second axially extending window pillar portion 340b. As shown in FIG. 7, the length 344 of the axially extending window pillar portions 340a and 340b is shorter than the length 346 of the axial pillar 232. The axially extending window pillar portions 340a and 340b are integrally formed with the frame 300, each window pillar portion extending from an upper (e.g., proximal) axial pillar 348. The axially extending window pillar portions 340a and 340b and the upper axial pillar 348 can together form an axially extending frame portion that defines the axial side of each of the two adjacent elongated units 350 in the upper column unit 324.

[0134] In some instances, the width of the upper axial support 348, which is defined in the circumferential direction and perpendicular to the central longitudinal axis of the frame, may be the same as the width of the axially extending window support portions 340a and 340b and / or the additional supports of the frame (e.g., angled supports 310).

[0135] In some instances, the width of the upper axial strut 348 may be greater than (e.g., thicker than) the width of the axially extending window struts 340a and 340b and / or additional struts of the frame (e.g., angled struts 310).

[0136] In some instances, the upper axial support 348 may include additional geometric features, such as holes or notches along one or more of its length.

[0137] The upper axial strut 348 is disposed between the upper (e.g., proximal) elongated strut joint 352 (e.g., the joint between the two angled struts 310 and the upper axial strut 348) and the upper edge 354 of the connecting window 342. The upper edge 354 is disposed substantially perpendicular to the upper axial strut 348 and offset laterally (e.g., circumferentially) from each other by the axially extending window strut portions 340a and 340b. In other words, the upper edge 354 may extend in a circumferential (or lateral) direction between the upper ends of each of the axially extending window strut portions 340a and 340b. As used herein, "upper" end, strut, or edge may refer to the end, strut, or edge of an assembly disposed closer to the proximal side of the frame 300 or the outlet end 308, and "lower" end, strut, or edge may refer to the end, strut, or edge of an assembly disposed further away from the outlet end 308 and toward the inlet end 306.

[0138] As shown in FIG. 7, in some embodiments, the lower elongated support surfaces connecting the lower ends of the support portions 340a and 340b are replaced by the open lower end of the connecting window 342. For example, in some cases, each axially extending window support portion 340a and 340b includes lower clamping portions 356a and 356b, which are formed by the lower curved (e.g., angled) portions of the respective axially extending window support portions 340a and 340b. As shown in FIG. 7, the curved portions of the lower clamping portions 356a and 356b are angled toward each other. Therefore, as shown in FIG. 7, the lower clamping portions 356a and 356b can jointly form a neck region at the lower end of the open connecting window 342.

[0139] In some instances, the connecting tabs of the coupling may extend through the open coupling window 342 to form a coupling assembly (e.g., a coupling assembled to frame 300). For example, in some cases, the connecting tabs of two adjacent leaflets may be inserted into the coupling window 342 through an opening defined between the lower clamping portions 356a and 356b.

[0140] In some instances, the axially extending window pillars 340a and 340b and their respective lower clamping portions 356a and 356b may laterally flex or elastically bend (e.g., laterally outward and away from each other) during leaflet insertion.

[0141] In some embodiments, the suture may cover or surround the lower clamping portions 356a and 356b (e.g., cover or surround the outer bends in each of the lower clamping portions) once the connecting tabs are positioned within the connecting window 342 to clamp the lower ends of the axially extending window pillars 340a and 340b together and prevent the connecting tabs from axially sliding out of the connecting window 34. In alternative embodiments, alternative fasteners or clamping members (e.g., straps, cords, cable ties, or the like) may be used to clamp the lower clamping portions 356a and 356b together.

[0142] In other instances, the lower end of each connecting window 342 can be closed and formed by a lower elongated support surface (e.g., similar to surface 352).

[0143] Furthermore, in some instances, the axial position of the upper edge 354 (along the central longitudinal axis of the frame 300) or the axial distance between the upper edge 354 and the outflow end 308 of the frame can be selected such that the leaflet as a whole or at least a large portion of the leaflet remains within the lower portion 358 of the unit in the first row of units 324 and the upper portion 360 of the unit in the upper row of units 324 remains substantially unobstructed by the leaflet. In this way, the connecting window 342 and thus the leaflet are axially offset toward the inflow end (which may also be referred to as the upstream end) of the first row of units 324. Therefore, during valve operation, the space for blood flow and / or access via the re-entry device through the upper (or outflow) portion 358 of the first row of units 324 is substantially increased.

[0144] For example, in some cases, the length 362 of the upper axial support 348 may be selected such that the axial distance 364 between the outlet end 308 of the frame 300 and the outlet edge of the leaflet at the junction (or the axial position of the upper edge 354, as indicated by the dashed line in FIG. 7) is within a selected range. In some instances, the selected range of the axial distance 364 is in the range of 2 to 6 mm, 2 to 4 mm, or 2 to 3 mm. In some instances, the selected range of the axial distance 364 is in the range of 20 to 50%, 25 to 45%, or 30 to 40% of the total axial distance (or height) 326 (FIG. 5) of the elongated unit 350. In some instances, the length 362 of the upper axial support 348 may be in the range of 0.75 to 2.5 mm, 1 to 2 mm, or approximately 1.5 mm. Therefore, the upper portion 358 of the unit in the first column 324 can be sized to provide sufficient blood flow and / or enter via a re-entry device.

[0145] In some instances, the outflow margin of the leaflet away from the commissure (and commissural flap, toward the center of the valve (towards the central longitudinal axis of the frame)) may be higher (closer to the outflow end 308) or lower than the outflow margin of the leaflet at the commissural flap.

[0146] In some instances, the outflow edge of the leaflet, which is away from the commissure (and commissural flap, toward the center of the valve (towards the central longitudinal axis of the frame)), may also be offset axially by a distance 364 from the outflow end 308 of the frame 300.

[0147] FIG8A shows another example of the window pillar portion of the connecting window 242 forming the frame 300. As shown in FIG8A, in some examples, the connecting window 242 may be formed by axially extending window pillar portions 370a and 370b extending (e.g., axially extending pillars) between the angled pillars 310 and 234 at the outflow end 308. In some examples, the window pillar portions 370a and 370b are formed as a single piece and may be collectively referred to as the axially extending window pillar or window pillar portion forming the connecting window 242. The window pillar portions 370a and 370b may be similar to the window pillar portion 240 shown in FIG5, but are assembled such that the connecting window 242 defined therein is moved downward toward the angled pillar 234 (and the inflow end of the valve). For example, as shown in FIG8A, window support portions 370a and 370b may form a first or upper portion 372 above the connecting window 242 (e.g., a portion closer to the end of the outlet 308) and a second or lower portion 374 below the connecting window 242 (e.g., a portion farther from the end of the outlet 308), wherein the upper portion 372 is larger (or thicker) than the lower portion 374 in the axial direction. Therefore, in some embodiments, the upper portion 372 may include a aperture 376. In some embodiments, the aperture 376 may be configured to accommodate one or more fasteners (e.g., sutures) within the connecting window 242 when the connecting tabs of the leaflets are secured to the frame.

[0148] In some instances, the upper portion 372 may include more than a single aperture 376, such as two or more apertures. For example, FIG8B shows another exemplary configuration of the window strut portions 1502a, 1502b (which constitute axially extending struts) of the connecting window 1504 forming the frame 1500 of the artificial heart valve. The upper portion 1506 (which may also be referred to herein as the "outflow portion") of the window strut portions 1502a, 1502b (located above the connecting window 1504 in FIG8B) includes two apertures 1508 disposed therein. The frame 1500 may be similar to one of the frames disclosed herein, such as frame 400 or 500 (as further described below). However, the configuration of the window strut portions 1502a, 1502b and the upper portion 1506 including the two apertures 1508 may be included in many different frames, such as any of the frames disclosed herein. The two openings 1508 can be assembled to accommodate one or more sutures or alternative fasteners for securing the syndesm for adjacent leaflets within the syndesm window 1504. In some cases, by using two openings 1508 (instead of using only one opening), the syndesm (forming a syndesm) can be secured more easily and reliably to the syndesm window 1504.

[0149] Returning to Figures 5 and 6, in some instances, forming a thinning region across the tip 304 can cause high stress at the center of the thinning region (e.g., the midpoint of the tip), which can reduce the strength of the tip. For example, for a frame 300 with a tip 304 (Figures 5 and 6), the point of maximum stress during radial expansion of the frame 300 can be experienced at the tip 304, as indicated by the dashed circle 330 in Figure 6. In some instances, the maximum stress at point 330 can be up to 2,140 MPa. It may be necessary to provide a frame for an artificial heart valve in which the maximum stress experienced during expansion does not exceed 2,000 MPa. In some instances, it is required that the maximum stress experienced by the frame during expansion is less than 1,700 MPa.

[0150] Therefore, it is necessary to provide a top or top region with reduced height, similar to the top 304 shown in Figures 5 and 6, but reducing the strain concentration at the top region and / or the maximum stress experienced by the frame during radial expansion away from the top movement.

[0151] In one example, strain concentration and / or maximum stress (such as those shown in Figures 5 and 6) experienced at the top of a frame with a reduced height top or top region having a thinned area can be reduced by altering the top region of the frame such that such top regions have a reduced width (relative to the angled columns of the frame) extending over a larger length (e.g., at least 25% of the length of the inflow or outflow column) of the top region. Exemplary examples of such frame configurations are shown in Figures 9A to 9C and Figures 10A to 10C, as described below.

[0152] Figures 9A to 9C show examples of a portion of a frame 400 having an outflow tip region 402 (one of those shown in Figures 9A and 9B) at the outflow end 406 of the frame 400 and an inflow tip region 404 (one of those shown in Figures 9A and 9C) at the inflow end 408 of the frame 400. In some instances, the outflow end 406 may include a plurality of outflow struts 460, each outflow strut 460 including an outflow tip region 402 at the outflow end 406 of the frame 400 and two angled strut portions 410 (which may be referred to as angled struts and may be similar to the angled struts 310 of the frame 300, as described above with reference to Figures 5 and 6). For example, each outflow tip region 402 may bend between two angled strut portions 410, wherein each strut portion extends between the outflow tip region 402 and different axial struts 232 (as shown in Figure 9A) or window strut portions. Similarly, the inflow end 408 may include a plurality of inflow pillars 462, each inflow pillar 462 including an inflow top region 404 and two angled pillar portions 410 at the inflow end 408 of the frame 400.

[0153] Each of the outflow top region 402 and the inflow top region 404 may include a top 412 (the highest or most outwardly extending point in the axial direction) and a thinned (or narrowed) support portion 414 extending from either side of the top 412 and connecting to a corresponding angled support portion 410 (Figures 9B and 9C). In this way, each of the outflow top region 402 and the inflow top region 404 may form a narrowed transition zone between and relative to the two angled support portions 410 extending from the corresponding top region.

[0154] In some instances, each of the outflow top region 402 and the inflow top region 404 may include a transition portion 420 (FIG. 9B) whose width narrows or gradually narrows from the corresponding angled pillar portion 410 to the corresponding thinned pillar portion 414.

[0155] In other instances, the outflow top region 402 and the inflow top region 404 may not include the transition portion 420, and in fact, the transition portion 420 may be included in the corresponding angled support portion 410.

[0156] The thinned support portion 414 of the outflow top region 402 and the inflow top region 404 may have a width 416 that is smaller than the width 418 of the angled support portion 410 (Figures 9B and 9C). In some instances, the width 416 may be a uniform width (e.g., along the entire length of the support portion 414). As described above, the width of the support portion (as used herein with reference to the width 416 of the thinned support portion 414 and the width 418 of the angled support portion 410) is measured between relative positions on opposite surfaces of the support portion extending radially between the inner and outer surfaces.

[0157] In some instances, the width 416 of the thinned support portion 414 may be approximately 0.06 to 0.15 mm smaller than the width 418 of the angled support portion 410. For example, in some cases, the width 418 of the angled support portion 410 may be approximately 0.3 mm and the width 416 of the thinned support portion 414 may be in the range of approximately 0.15 to 0.24 mm. In some instances, the width 416 of the thinned support portion 414 may be in the range of approximately 0.18 to 0.22 mm. In some instances, the width 416 of the thinned support portion 414 may be approximately 0.2 mm (e.g., ±0.03 mm). The width 416 may also be referred to as the width of the outlet top region 402 and the inflow top region 404.

[0158] Compared to the top of frame 300 (Figs. 5 and 5), the outflow top region 402 and inflow top region 404 of frame 400 (Figs. 9A to 9C) have thinned support portions 414 extending over a larger distance between the angled support portions 410. For example, the thinned support portion 414 of the outflow top region 402 may have a first length 422 (Fig. 9B). In some instances, this first length is in the range of 0.8 to 1.4 mm, 0.9 to 1.2 mm, or 0.95 to 1.05 mm. In some instances, this first length is about 1.0 mm (e.g., ±0.03 mm). Therefore, the thinned support portion 414 extending from and on either side of the top 412 of the outflow top region 402 may have this first length 422 (only one first length 422 is shown in Fig. 9B). In other words, each outflowing top region 402 may include two thinned pillar portions 414 having the first length 422, each extending outward from the top 412 relative to the central longitudinal axis 426 of the unit. Therefore, the total length of the top region 402 may be twice the first length 422 (e.g., in the range of 1.6 to 2.8 mm, 1.8 to 2.4 mm, or 1.9 to 2.2 mm, or about 2.0 mm).

[0159] Furthermore, in some instances, the thinned pillar portion 414 flowing into the top region 404 may have a second length 424, wherein the second length 424 is less than the first length 422 (FIG. 9C). In some instances, the second length 424 is in the range of 0.3 to 0.7 mm, 0.4 to 0.6 mm, or 0.45 to 0.55 mm. In some instances, the second length 424 is about 0.5 mm (e.g., ±0.03 mm). Each of the two thinned pillar portions 414 flowing into the same top region 404 may have the second length 424 (only one length is indicated in FIG. 9C). Therefore, the total length of the top region 404 may be twice the second length 424 (e.g., in the range of 0.6 to 1.4 mm, 0.8 to 1.2 mm, or 0.9 to 1.1 mm, or about 1.0 mm).

[0160] Each outflow support 460 and inflow support 462 may have a length including a top region (402 or 404), a transition portion or region 420, and two angled support portions 410 on either side of the top region. Half of the total length of each outflow support 460 and inflow support 462 is shown as length 425 in Figures 9B and 9C, extending from one end of one angled support portion 410 to the central longitudinal axis 426. Therefore, the length of each outflow support 460 and inflow support 462 is twice the length 425. In some instances, half the length 425 of each inflow support 462 may differ from half the length 425 of each outflow support 460.

[0161] The length of each thinned support portion 414 may be at least 25% of the length 425 of the corresponding half of the outflow support 460 or inflow support 462. In other words, the length of each outflow tip region 402 (the total length being twice the first length 422) and the length of each inflow tip region 404 (the total length being twice the second length 424) may be at least 25% of the total length of the outflow support 460 or inflow support 462 (twice the length 425). In some instances, the length of each tip region (e.g., the outflow tip region 402) may be greater than 25% of the total length of the corresponding outflow support 460 or inflow support (twice the length 425), such as 25% to 35%.

[0162] In some embodiments, each outflow top region 402 and inflow top region 404 may include a curved axially facing outward surface 428 and an arcuate or curved axially facing inward recess 430, which form a thinned support portion 414. For example, the curved inward recess 430 may be recessed from the inner surface of the angled support portion 410 toward the curved outer surface 428, thereby forming a thinned support portion 414 with a smaller width. Thus, the curved inward recess 430 may be formed on the unit side of the top region (e.g., relative to the outside of the top region).

[0163] In some instances, the curved outer surface 428 of each tip region (402 or 404) may form a single continuous curved surface from an angled strut portion 410 on a first side of the tip region to another angled strut portion 410 on the opposite second side of the tip region. In contrast, the tips of the frames of the artificial heart valves 10 and 200 shown in Figures 1 and 3 may each include three or four bends (e.g., tip 220 has four bends or curved surfaces from an angled strut on one side of the tip to another angled strut on the opposite side of the tip).

[0164] Each outflow tip region 402 and inflow tip region 404 may have a radius of curvature 432 along the curved outer surface 428 (e.g., in some cases, along the entire length of the curved outer surface 428). The radius of curvature 432 at the tip 412 and / or along the entire curved outer surface 428 of the tip region may be larger than a previous tip design having a more pointed or U-shaped shape. In some instances, the radius of curvature 432 may be greater than 1 mm. In some instances, the radius of curvature 432 may be in the range of 1 to 20 mm, 3 to 16 mm, or 8 to 14 mm. In some instances, the radius of curvature 432 may be greater than 10 mm. In some instances, the radius of curvature 432 may be about 13.5 mm (±0.03 mm). The radius of curvature 432 may depend on the width 416 of the thinned support portion 414 (e.g., the reduction in the width of the self-angled support portion 410) and the length (422 or 424) (and thus change due to the change in width and length).

[0165] In some instances, the radius of curvature 432 may be defined such that the top region (inflow to top region 404 or outflow from top region 402) is flat (e.g., the radius of curvature 432 may be infinite). For example, in such cases, the outer surface 428 may be planar, wherein the planar outer surface 428 is defined perpendicular to the central longitudinal axis 426.

[0166] Furthermore, the height (axial height) 464 of the outflow top region 402 and the inflow top region 404, defined in the axial direction from the outer surfaces of the two angled support portions 410 to the curved outer surface 428 of the top region at the top 412, can be the width 416 of the thinned support portion 414 (as shown in FIG9B). In this way, the height 464 of the outflow top region 402 and the inflow top region 404 can be relatively small and will not significantly increase the overall axial height of the radially expanding frame 400. Therefore, as described above, the leaflets fastened to the frame 400 can be closed to the inflow end 408, thereby leaving a larger open space at the outflow end 406 of the frame 400 that is not obstructed by the leaflets.

[0167] The remainder of frame 400 may resemble frame 300 of Figures 5 and 6. In some instances, each of the outflow top region 402 and the inflow top region 404 may form an angle 440 (Figure 9A) between two angled support portions 410 extending from either side of the corresponding top region. In some instances, angle 440 may resemble angle 320 of frame 300. For example, in some cases, angle 440 may be in the range of 120 degrees (excluding the endpoints) to 140 degrees (e.g., such that angle 440 is greater than 120 degrees and less than or equal to 140 degrees). In some instances, angle 440 may be in the range of 135 to 140 degrees, 138 to 140 degrees, or 139 to 140 degrees. In some instances, angle 440 may be approximately 140 degrees (e.g., ±1 degree).

[0168] The point of maximum stress in the frame 400, which has the outflow top region 402 and inflow top region 404 as described above (during the expansion of the frame 400), may be at the outflow top region 402, as indicated by the dashed circle 434 in Figure 9A. In some instances, the maximum stress at point 434 may be 1,795 MPa. Although this maximum stress is less than the maximum stress of the frame 300 (Figure 6), it may still be necessary to have a frame with a lower maximum stress in the top region away from the frame.

[0169] Figures 10A to 10C show another example of a portion of a frame 500 having a top region 502 at both the inflow end 508 and the outflow end 506 of the frame 500. The top region 502 may be the same as or similar to the outflow top region 402 of the frame 400. For example, each top region 502 (at both the inflow and outflow ends) may include a top 412 and two thinned support portions 414, one of which extends from either side of the top 412 to a corresponding wider angled support portion 410. Furthermore, similar to the top region 402 of the frame 400, each top region 502 at both the inflow end 508 and the outflow end 506 of the frame 500 may have a width 416 and a thinned support portion having a first length 422.

[0170] In addition, each top region 502 and the two corresponding angled pillar portions 410 can form an outflow pillar 560 at the outflow end 506, and each top region 502 and the two corresponding angled pillar portions 410 can form an inflow pillar 562 at the inflow end 508.

[0171] Similar to frame 400, the first length 422 of thinning the support portion 414 can cause the total length of the top region 502 to be at least 25% of the total length of the corresponding outflow support 560 or inflow support 562 (twice the length 425 shown in Figures 10B and 10C). In some instances, the length of each top region 502 can be greater than 25% of the total length of the outflow support 560 or inflow support 562 (twice the length 425), such as 25% to 35% (Figures 10B and 10C).

[0172] Therefore, for the frame 500, both the inlet end 508 and the outlet end 506 of the top region 502 may have a longer, thinner support portion 414 having the first length 422. This configuration of the top region 502 may cause a reduction in maximum stress at a location spaced apart from the top region 502. For example, the maximum stress point of the frame 500 (during the expansion of the frame 500) may be experienced in the region of the angled support portion 410, close to the support joint 510 and far from the top region 502, as indicated by the dashed circle 512 in FIG10A. In some instances, the maximum stress at point 512 may be 1,619 MPa.

[0173] In some instances, the top region 502 of the frame 500 may be further defined by an angle 440 and a radius of curvature 432 (Fig. 10A), as described above with reference to Figs. 9A to 9C.

[0174] In some instances, the frame 500 may include an axially extending window pillar portion 514 that defines the connecting window 520 of the frame 500 (FIG. 10A). The window pillar portion 514 may form an upper (or outflow) end portion 516 above the connecting window 520 and a lower (or inflow) end portion 518 below the connecting window 520, wherein the upper end portion 516 is larger than (or longer in the axial direction than) the lower end portion 518. This configuration allows the connecting window 520 to be slightly offset toward the inflow end 508 of the frame 500 (similar to that described above with reference to window pillar portions 370a and 370b in FIG. 8).

[0175] In other examples, as shown in a partial frame view of FIG11, frame 500 may include axially extending window pillar portions 522 defining the connecting window 520 of frame 500. Window pillar portions 522 may form an upper (outflow) end portion 524 above the connecting window 520 and a lower (inflow) end portion 526 below the connecting window 520, wherein the length 528 of the upper end portion 524 (in the axial direction) is the same as or substantially the same as the lower end portion 526 (FIG. 11). In some examples, the length 528 of the upper end portion 524 and the lower end portion 526 may be greater than the width 418 of the frame pillars (e.g., angled pillar portions 410). For example, in some cases, the length 528 may be in the range of 0.35 to 0.5 mm or 0.38 to 0.45 mm or approximately 0.4 mm (e.g., ±0.03 mm).

[0176] The reduction in maximum stress away from the tip region 502 during the radial expansion of frame 500 (compared to previously disclosed frames, including frames 300 and 400) can be attributed to the stress intensification of tip region 502 that occurs during radial compression or curling of frame 500 into its radial compression configuration. For example, as shown in FIG12, frame 500 may be radially compressed or curled into radial compression configuration 530 (e.g., for delivery to a target implantation site on a distal portion of a delivery device) and then (e.g., after reaching the target implantation site for implantation) radially expanded into its radial expansion configuration 532. FIG12 shows an overlapping view of frame 500 in its radial compression configuration 530 and its radial expansion configuration 532 for comparative purposes.

[0177] As an example, when the frame 500 is rolled into its radially compressed configuration 530, the top region 502 specifically bends and plastically deforms around a more central region including the top 412. Therefore, the top region 502 undergoes strain hardening (or stress reinforcement). As shown in Figure 12, the point of maximum stress during rolling occurs at the top region 502, as indicated by the dashed circle 534.

[0178] Next, during the subsequent radial expansion configuration 532, since the top region 502 has already been strain-hardened, it will not plastically deform during expansion. In fact, the point of maximum stress during the expansion of the frame 500 can occur away from the top region 502 along the angled support portion 410, as indicated by the dashed circle 536 in Figure 12. In this way, the bending points of the frame between the curling and expansion of the frame 500 are respectively shifted from the top region 502 to points away from the top region 502 (as indicated by circle 536). Therefore, the top region 502 can be more robust and less likely to undergo degradation, and the frame 500 can be more stable.

[0179] As shown in Figures 11 and 12, the frame 500 may also include horizontal pillars 538 extending between adjacent units 535 in a column of units of the frame 500. The horizontal pillars 538 may extend in a circumferential direction and are also referred to as circumferentially extending pillars 538. The horizontal pillars 538 may connect two adjacent columns of angled pillars of the frame 500 to each other. For example, each horizontal pillar 538 may connect to two angled pillars in one column (e.g., pillar 537 shown in Figure 11) and two angled pillars in another adjacent column (e.g., pillar 539 shown in Figure 11). Therefore, the angled support 539 extending between the connecting window 520 and the horizontal support 538, and the angled support 537 extending between the horizontal support 538 and another horizontal support 538 disposed adjacent to the inflow end 508 of the frame, can be aligned along the angled line that follows the fan-shaped line of the leaflet (when the leaflet is attached to the frame 500). Thus, the horizontal support 538 allows the angled support to follow a shape that more closely matches the shape of the fan-shaped line of the leaflet when the frame 500 is in the radially expanded configuration 532. In addition, the horizontal support 538 can serve as a spacer that can maintain the gap 533 between the angled supports (as shown in FIG. 12) when the frame 500 is in the radially compressed configuration 530, thereby reducing the risk of the leaflet being pinched between the supports in the radially compressed configuration 530.

[0180] FIG13 is a perspective view of an example of an artificial heart valve 600 including a frame 620 and an outer (fabric) side edge 602 fastened to the frame 620. The frame 620 may include a plurality of interconnected and angled struts 630 and a plurality of top regions 632 at the inlet end 622 and the outlet end 624 of the frame 620. The frame 620 may be similar to (or replaced by) any of the frames described herein, such as frame 300 (FIGs 5 to 8), frame 400 (FIGs 9A to 9C), or frame 500 (FIGs 10A to 10C). As shown in FIG13, the outer edge 602 may extend around the outer surface of the frame 620 from the inlet end 622 toward the outlet end 624 (covered by the outer edge 602 in FIG13). In some instances, as shown in FIG13, the outer edge 602 may be fastened to the struts of the frame at the inlet end 622 by one or more sutures 604.

[0181] Furthermore, in some embodiments, the outflow end of the outer edge 602 may be secured to the inflow end portion 248 of the axial strut 232 and / or the upper part or outflow end of the angled strut 234 by one or more sutures 606 (see FIG. 5). In some embodiments, a portion of the suture 606 may extend through and be secured to a hole 249 in the inflow end portion 248 of the axial strut 232 (the hole 249 is shown by the dashed line in FIG. 13 to indicate its location below the outer edge 602). In some embodiments, the suture 606 and / or the suture 604 may be inlet and outlet sutures.

[0182] In some instances, as shown in FIG13, an additional stitch 608, which can be assembled as an overlap, can fasten the outer edge 602 to the angled pillar of the frame 620, which is positioned between the inflow end 622 and the inflow end of the window pillar portion forming the combined window of the frame 620 and extends therebetween.

[0183] As described above, the exposed tip of the artificial heart valve frame can interact with the inflatable balloon of the delivery device on which the artificial heart valve is mounted (and compressed radially around it) and / or the delivery sheath through which the delivery device advances toward the target implantation site. Therefore, the exposed tip of the artificial heart valve frame may cause damage to the delivery device, the delivery sheath, and / or the patient's vascular structures. The tip regions (402, 404) of frame 400 (Figures 9A to 9C) and tip region 502 of frame 500 are less damaging than previously exposed tips with a more pointed or U-shaped tip due to their larger circular curl profile (which can be provided by the increased angle and shape of the tip region, as described above).

[0184] For example, as shown in FIG12, when the frame 500 is in a radially compressed configuration 530, the tip region 502 forms a curved shape along its outer surface 428. This shape can facilitate easier sliding over the inflatable balloon of the delivery device as the artificial heart valve is pushed from its initial installation position (e.g., away from or partially away from the balloon) to an deployed position above the balloon (e.g., when the artificial heart valve is initially curled away from most of the balloon). The continuous curved shape of the tip region of the frame can also reduce the likelihood of the tip region (e.g., at tip 412) penetrating into the balloon (when initially installed on the balloon, as shown in the illustrative delivery device of FIG2) and / or penetrating into the delivery sheath during delivery to the target implantation site.

[0185] In some instances, it may be necessary to provide an even more undamaged surface at the top region (e.g., at least at the far end of the frame, which may be the inflow end). In one instance, the height-reduced, curved, and thinner top regions (e.g., top regions 402, 404, and / or 502) may be further rounded and / or corner-removed at their edges (e.g., the outer edges forming the curved outer surfaces 428 shown in Figures 9B, 9C, 10B, 10C, and 12).

[0186] In another example, as shown in Figures 14A and 14B, the exemplary tip region 502 (or alternatively tip region 402 or 404) shown in Figure 14A may be rotated or twisted about its axis 702 (which may be referred to as the transverse axis) in the direction of arrow 704 to form a twisted outer surface 706 (Figure 14B). This twisted outer surface 706 may be less blunt and less damaging to conveyor components and / or native anatomy exposed to or in contact with the tip region 502.

[0187] In another example, at least a portion of one or more top regions (e.g., top regions 402, 404, and / or 502) of a frame (e.g., one of frames 400 or 500) may be covered by a buffer element. For example, in some cases, as shown in FIG15, a buffer element 802 may cover at least a portion of the top region 502 at the inflow end 508 of the frame 500. In other examples, the frame 500 may be replaced by the frame 400 (FIGs 9A to 9C) and the buffer element 802 may cover the inflow top region 404 and / or the outflow top region 402.

[0188] As shown in FIG15, a buffer element 802 may be coupled to and cover at least a portion of the top region 502 (e.g., the distal end, such as the top 412) at the inflow end 508 of the frame 500. In some instances, each top region 502 at the inflow end 58 may be at least partially covered by a different buffer element 802.

[0189] The cushioning element 802 may comprise a flexible material folded over the top region 502 (e.g., the central portion of the top region 502 including the top 412). In some instances, the flexible material may be a fabric. In other instances, the flexible material may be another type of relatively soft flexible material, such as a fabric, a relatively soft flexible polymer (e.g., silicone), or the like. When made of fabric, the fabric fibers may be made of any of a variety of biocompatible materials, such as polyethylene terephthalate (PET). The fabric may be a woven, nonwoven, or napped fabric (e.g., velvet, cotton, etc.) having clusters or loops of fibers extending from a self-woven base layer. Any of the various fabrics disclosed in U.S. Publication No. 2019 / 0192296, which is incorporated herein by reference, may be used to form the cushioning element 802.

[0190] In some embodiments, the cushioning element 802 includes a plurality of folds 804 disposed above and extending across the curved outer surface 428 of the top region 502 to form the distal surface (or layer) 806 of the cushioning element 802. In this manner, the plurality of folds 804 may be formed above and across the top 412 of the top region 502. The plurality of folds 804 may extend between the inner layer 808 and the outer layer 810 of the cushioning element 802, wherein the inner layer 808 covers the radially inward inner surface of the corresponding top region 502 (e.g., towards the central longitudinal axis of the frame) and the outer layer 810 covers the radially outward surface of the corresponding top region 502 (e.g., away from the central longitudinal axis of the frame). In this manner, the inner layer 808 is positioned closer to the central longitudinal axis than the outer layer 810.

[0191] In some instances, the inner layer 808 and outer layer 810 of the buffer element 802 may extend along / across the entire width 416 of the top region 502.

[0192] By covering at least the curved outer surface 428 of the tip region 502, at the tip 412, the buffer element 802 can further reduce wear between the exposed tip region 502 and the inner surface of the inflatable balloon and / or sheath of the delivery device during the delivery of the artificial heart valve to the target implantation site, thereby reducing the degradation of the sheath and / or balloon.

[0193] It should be understood that references to the distal and proximal ends of the artificial valve and / or frame 500 may refer to the position of the valve's distal end during delivery on the delivery device. For example, when an artificial heart valve including frame 500 (or frame 400) is mounted on the distal portion of the delivery device (as depicted in Figures 2 and 4), the inflow end of the artificial valve is the most distal end of the artificial valve, and the outflow end of the artificial valve is the most proximal end of the artificial valve. This configuration is suitable for retrograde delivery of the artificial heart valve across the aorta to the native aortic valve. However, in other instances, depending on the specific delivery method and the specific implantation location within the heart, the outflow end of the artificial heart valve may be the distal end of the artificial heart valve during delivery. For example, when the artificial heart valve is delivered to the native mitral valve via a transseptal delivery pathway, the outflow end of the artificial heart valve may be the most distal end of the artificial valve. Therefore, depending on the specific delivery method used for the surgery and the specific implantation location within the heart, the buffer element 802 (and / or buffer elements assembled in different ways) can be installed on the inflow or outflow end of the artificial valve.

[0194] In other examples, the buffer element 802 may be installed on both the inlet and outlet ends of the artificial heart valve. In still other examples, the buffer element 802 may be installed only on the tip region 502 at the inlet end of the artificial heart valve.

[0195] In some instances, as shown in FIG15, each of the plurality of tip regions 502 (e.g., at least at the inlet or distal end of the frame during delivery) includes a discrete buffer element 802 that covers at least the tip 412 of the tip region 502. In alternative instances, a single buffer element may cover each of the plurality of tip regions 502 at the inlet end 508 of the frame 500. For example, in such cases, the single buffer element may comprise a single circumferential sleeve that is configured integrally around the circumference of the inlet end 508 and covers the entire tip region 502 at the inlet end 508. In other instances, the frame 500 may include two or more buffer elements, each covering at least two tip regions 502. In still other instances, one or more buffer elements may be portions of the outer or inner lateral edge of the valve. In these instances, the lateral edge may have an integral individual buffer element or a single buffer element.

[0196] Figures 20 to 29 illustrate additional examples of covering and / or cushioning elements for the tip region of a frame for an artificial heart valve. For example, such coverings and / or cushioning elements can, for instance, reduce friction between the tip region and one or more components of the delivery device or system (such as a guide or guide sheath, delivery sheath, and / or balloon of the delivery device), for example, when the artificial heart valve is radially compressed around a portion of the distal portion of the delivery device and / or advances relative to the delivery sheath (e.g., to expose the artificial heart valve at the implantation site). Furthermore, in some instances, the radially compressed artificial heart valve on the delivery device can be an expandable delivery sheath as it advances through its delivery sheath. Thus, during advancement through the expandable delivery sheath, the artificial heart valve can exert radial forces to expand the sheath (e.g., against a vessel wall) and apply an axial force component (e.g., shear pressure) against the inner wall of the sheath during advancement, generated by contact with the frame (e.g., the inflow tip or tip region of the frame). This axial force component is proportional to the coefficient of friction between the tip (or tip region) and the delivery sheath, and the stress is inversely proportional to the area (force divided by the contact area). Therefore, it may be necessary to reduce the coefficient of friction and increase the contact area at the distal end of the artificial heart valve (e.g., the inflow end, when using a transfemoral delivery method in the case of an artificial aortic valve) to reduce the axial force component as the valve advances through the delivery sheath.

[0197] Figures 20 to 24 illustrate examples of one or more top regions of a frame for an artificial heart valve covered with material. For example, such coverings may reduce friction, provide cushioning, and / or provide non-abrasive coverage of the top regions. The coverings may be formed of various materials, such as polymers or fabrics. For example, one or more top regions (e.g., top regions 402, 404, and / or 502) of a frame (e.g., one of frames 400 or 500) may be covered by a covering element that surrounds or covers the circumference of the strut portion forming the top region. In some instances, as shown in Figure 20, a covering element 1100 (e.g., a suture or another strip or band of polymer or fabric material) may cover at least a portion of the top region 502 and / or cover at least a portion of the top region 502 at the inlet end 508 of frame 500.

[0198] It should be noted that, by way of example, frame 500 is used in Figures 20 to 24, and in other instances, covering element 1100 may cover the top area or top of any of the other frames described herein in a manner similar to that described below with reference to Figures 20 to 24.

[0199] As described above, each top region 502 may include a top 412 and two thinned pillar portions 414, one thinned pillar portion 414 extending from each side of the top 412 to a corresponding wider angled pillar portion 410 flowing into the pillar 562 (or outflowing from the pillar 560). Furthermore, each top region 502 may include a curved axially facing outward surface 428 and a recess 430 forming within the thinned pillar portion 414. In some embodiments, the curved outer surface 428 of each top region 502 may form a single continuous surface from one angled pillar portion 410 on a first side of the top region 502 to another angled pillar portion 410 on an opposite second side of the top region 502.

[0200] Therefore, each top region 502 may include shoulders 540 (or shoulder portions) on both sides or ends of the top region 502, which transition from the narrower, thinner support portion 414 of the top region 502 to the wider, angled support portion 410 of the corresponding inflow support 562 or outflow support 560. The shoulders 540 may be disposed on the axially inward-facing surface 542 of the inflow support 562 or the portion disposed on the axially inward-facing surface of the outflow support 560.

[0201] As shown in FIG20, the covering element 1100 may surround and cover at least a portion of the top region 502. In some embodiments, the covering element 1100 may surround and cover a portion or the entire thinned pillar portion 414 between the shoulders 540 of the top region 502. In other embodiments, the covering element 1100 may surround and cover a portion of the top region 502 and one or more of the angled pillar portions 410 connected to the top region 502 (e.g., as shown in FIG21 to 24 and further described below).

[0202] In some instances, the covering element 1100 may surround and cover the top region 502 of one or more of the inflow pillars 562 (e.g., in some cases, each inflow pillar 562). In some instances, the covering element 1100 may surround and cover the top region 50 of one or more of the outflow pillars 560.

[0203] The covering element 1100 may be assembled as a strip or band of material surrounding (or covering) the top region 502. The covering element 1100 may cover the circumference of the thinned support portion 414 of the top region 502 such that a plurality of loops 1102 are formed adjacent to each other across the top region 502 (e.g., relatively tight loops, such that the loops 1102 contact the thinned support portion 414 without drooping from it). In some cases, adjacent loops may at least slightly overlap each other. In other cases, adjacent loops may be adjacent to each other (i.e., non-overlapping). In still other cases, adjacent loops may include gaps between slightly exposed portions of the top region.

[0204] The cover element 1100 may comprise a relatively smooth material, such as polytetrafluoroethylene (PTFE). In some instances, the cover element 1100 may be a strip or monofilament comprising a high-strength material with a relatively low coefficient of friction, such as ultra-high molecular weight polyethylene (UHMWPE) or polyetheretherketone (PEEK). Such materials can provide a larger radius of curvature, which can reduce abrasion on the delivery sheath as the radially compressed artificial heart valve is guided through the delivery device to the implantation site.

[0205] As shown in FIG20, in some embodiments, the cover element 1100 may be coupled at one end to a shoulder 540 of the top region 502 (e.g., by braiding or tying that end of the cover element 1100 to a knot, such as a "grandmother" or double knot) and then repeatedly wrapped around the thinned support portion 414 of the top region 502 to the opposite shoulder 540 of the top region 502. Thus, a plurality of loops 1102 of the cover element 1100 may be formed across the top region 502 between the two shoulders 540 of the top region 502.

[0206] In some instances, the remaining or free ends of the strands of the cover element 1100 may pass below the last (or end) loop 1104 of the cover element 1100 to lock it in place around the top region 502. From the last loop 1104, the free ends of the strands of the cover element 1100 may then extend toward the nearest shoulder 540 adjacent to the top region 502 (FIG. 20), thereby forming a bridging portion 1106. The free ends of the cover element 1100 may then surround or cover the adjacent top region 502.

[0207] In some instances, this procedure may be repeated to form a single strip or band (or one or more strips or bands connected together) extending around and between all top regions 502 at the inflow end 508 (or outflow end 506) of the frame 500 to form a covering element 1100. Thus, all inflow top regions 502 at the inflow end 508 (and / or outflow end 506) of the frame 500 may be covered by the covering element 1100. In this manner, the covering element 1100 may include multiple loops 1102 surrounding and covering each top region 502 at the inflow end 508 (and / or outflow end) of the frame 500 and multiple bridging portions 1106 (or extensions) between loops 1102 of adjacent top regions 502. These multiple bridging portions 1106 may extend across the inflow end 508 of the frame from multiple loops 1102 of one top region 502 to other multiple loops 1102 of adjacent top regions. This can cause the covering element 1100 to create a ring of covering material around the circumference of the frame 500 at the inlet end 508.

[0208] In some instances, as shown in FIG27, the covering element 1100 may also extend through an outer edge disposed around the outer surface of the frame 500, thereby securing the outer edge to the frame 500. For example, an exemplary outer edge 1150 disposed around the outer surface of the frame 500 may be secured or sewn to the inlet end of the frame using the covering element 1100 (FIG. 27). FIG. 27 shows an internal view of a portion of the frame 500, wherein the outer edge 1150 is disposed around the frame and secured to the frame (the outer edge 1150 appears behind the frame 500 in FIG. 27 as it is an internal view). The outer edge 1150 shown in FIG. 27 may comprise any combination of materials described herein with reference to the outer edge of an artificial heart valve. In addition, in alternative examples, different lateral edges can be fastened to frame 500 or another frame of the artificial heart valve in a manner similar to that described below with reference to Figures 27 and 28A to 29 (e.g., lateral edge 1150 can be replaced by lateral edge 602 of Figure 13 or lateral edge of Figure 1 and / or frame 500 or 600 can be replaced by frame 400 of Figure 9A or frame 300 of Figure 5).

[0209] As shown in FIG. 27, the covering element 1100 may extend along the inflow edge portion 1152 of the outer edge 1150 around the top region 502 of the frame 500 (as described above) and through the material (e.g., fabric) of the outer edge 1150. In some cases, one or more or each of the loops 1102 of the covering element may wrap around the top region 502 (as described above) and extend through the outer edge 1150. From the last loop 1104, the covering element 1100 may then be sewn through the inflow edge portion 1152 of the outer edge 1150, thereby forming a plurality of seams 1154 through and around the inflow edge portion 1152 between adjacent top regions 502.

[0210] Figures 28A to 28C illustrate an exemplary method for forming a loop 1102 and an overlap 1154 and securing the outer edge 1150 to another exemplary frame 620 with a cover element 1100. Similar to other frames described herein, frame 620 may include a top region 632 (632a and 632b shown in Figures 28A to 28C) extending between angled pillars 630. Turning first to Figure 28A, starting at the first top region 632a of frame 620, the cover element 1100 may extend through the inflow edge portion 1152 of the outer edge 1150 (e.g., using a needle) and surround the first top region 632a (e.g., adjacent to a first shoulder of the first top region 632a) to form a first loop 1103. In some cases, the cover element 1100 may extend through this first loop 1103 to form a knot (e.g., a first braided loop 1103). The covering element 1100 may then cover the first top region 632a adjacent to the first loop 1103 to form a plurality of loops 1102 (which may be overlaps in some cases). In some instances, three loops 1102 may be formed. However, in alternative instances, the number of loops 1102 may be greater than or less than three, such as two, four or the like.

[0211] After forming loop 1102, in some instances, a final loop 1104 (FIG. 28B) can be formed by sewing a locking seam to the cover element 1100. In some instances, a locking seam can be formed around the first loop 1103 by the cover element 1100, thereby forming a first node 1156, and then another locking seam can be formed around the final loop 1104, thereby forming a second node 1158 (FIG. 28B). However, in other instances, only one node or no node may be formed adjacent to loop 1102.

[0212] A continuous seam 1154 from the first top region 632a may then be formed around and through the inflow edge portion 1152 of the outer edge 1150 between the first top region 632a and the adjacent second top region 632b (FIG. 28C). This procedure may then be repeated to form a loop 1102 above each top region 632 and to form a seam 1154 between adjacent top regions 632 along the inflow edge portion 1152 of the outer edge 1150.

[0213] Figure 29 shows the final configuration of the artificial valve, including fastening to the outer edge 1150 of the frame 620 and the apical region 632 covered by the cover element 1100. It should be noted that the three loops 1102 of the cover element 1100 are shown in Figure 29 extending through the outer edge 1150, but in alternative cases, fewer than three loops 1102 may extend through the outer edge 1150 (e.g., two or only one). For example, in such cases, only a portion of the loop 1102 covering the apical region 632 may also extend through the outer edge 1150. Furthermore, the technique described above for fastening the outer edge to the inlet end of the frame using a cover element covering the apical region (or apex) of the frame can be applied to various different outer edges and frames, such as any combination of outer edges and frames described herein.

[0214] By using the same component (covering element 1100) to cover the top region of the frame and attaching the outer edge 1150 to the frame, the artificial heart valve can be assembled more quickly and easily. Furthermore, by using the same covering element 1100 (e.g., suture) to cover the inflow to the top region and secure the outer edge 1150 to the frame, the curl profile of the artificial heart valve can be reduced (compared to using a first covering element or suture to cover the top region and using a second element or suture to attach the outer edge 1150 to the frame). Additionally, by extending the covering element 1100 through the outer edge 1150, the loop 1102 of the covering element 1100 can be more securely secured in place around the top region, preventing it from moving or sliding away from the top region during radial compression of the artificial heart valve. Therefore, the covering element 1100 can maintain coverage of the top region when the artificial heart valve is in a radially compressed configuration.

[0215] Figures 21 to 24 illustrate additional examples of a covering element for one or more top regions 502 of the frame 500 (or any of the other top regions or tops of the frame described herein). As shown in Figures 21 and 22, the covering element 1200 may include a plurality of loops 1202 that cover one or more top regions 502 at one end of the frame 500 (e.g., inflow end 508). Although Figures 21 and 22 show loops 1202 of the covering element 1200 covering the entire inflow support 562, in other instances, loops 1202 may cover only the top regions 502 (between the shoulders 540), as shown in Figure 20. Furthermore, in some instances, the covering element 1200 may include bridging portions that are the same as or similar to the bridging portion 1106 shown in Figure 20.

[0216] In some instances, as shown in Figures 21 and 22, the covering element 1200 may include nodes 1204 formed between loops 1202 covering adjacent inflow pillars 562 (and / or outflow pillars 560), such nodes being formed around pillar joints 510 between adjacent inflow pillars 562.

[0217] In an alternative embodiment, in Figures 21 and 22, node 1204 may be replaced by forming a longitudinal slit in the strip or strand of the cover element 1200 and allowing the cover element 1200 to pass through itself at the location of node 1204. For example, Figures 23 and 24 illustrate the following case: the cover element 1300 includes a plurality of loops 1302 covering the top region 502 at one end of the frame 500 (e.g., the inflow end 508) and a plurality of connecting portions 1304 extending between adjacent inflow supports 562 across the support joints 510.

[0218] As described above with reference to the cover element 1100 in Figure 20, the cover elements 1200 in Figures 21 and 22 and / or the cover elements 1300 in Figures 23 and 24 may include strips, strands, or sutures containing materials with a relatively low coefficient of friction, such as PTFE, UHMWPE, or PEEK, thereby facilitating smooth sliding of the inlet end 508 of the artificial heart valve over and through the inner wall of the delivery sheath. For example, the coefficient of friction between the cover element 1100 and the delivery sheath should be lower than the coefficient of friction between the bare metal of the artificial heart valve frame and the delivery sheath.

[0219] In some instances, the covering element described herein may have a static coefficient of friction in the range of 0.04 to 0.4, 0.04 to 0.2, or less than 0.2 relative to the inner wall of the conveyor jacket. In some instances, the covering element described herein may have a dynamic coefficient of friction in the range of 0.04 to 0.2, 0.04 to 0.1, or less than 0.1 relative to the inner wall of the conveyor jacket.

[0220] The width of the strips, tapes, or stitches comprising the covering elements 1100, 1200, and / or 1300 can be selected to increase the contact area between the tip region 502 (e.g., at the inflow end 508) and the inner wall of the delivery sheath, thereby reducing the shear stress below the sheath yield strength generated by dividing the force (e.g., the axial force component) by the total contact area. For example, this can reduce the likelihood of the valve being abraded on the delivery device (e.g., the sheath).

[0221] For example, Figures 21 and 22 show a covering element 1200 including a strip, band or suture having a first width of 1206, and Figures 23 and 24 show a covering element 1300 including a strip, band or suture having a second width of 1306, which is greater than the first width of 1206.

[0222] In addition to reducing the shear pressure of the tip region 502 against the delivery sheath during the navigation of the artificial heart valve through the delivery sheath to the implantation site, the proposed covering element may, for example, improve the alignment between the artificial heart valve and the balloon on the delivery device.

[0223] For example, during the deflating of the balloon (e.g., the deflating of the inflatable balloon around the delivery device to radially compress the artificial heart valve), the artificial heart valve may be positioned in a radially compressed configuration by approaching the deflation balloon, which may contain a series of folds disposed around its circumference.

[0224] In reality, the folds of the balloon may not be folded in a neat or organized manner. Therefore, as the radially compressed artificial heart valve advances toward and above the balloon after reaching the implantation site, some folds of the balloon may be caught at the inlet end of the frame on the strut interface (e.g., strut interface 510) and prevent further advance of the artificial heart valve above the balloon. In some cases, this can even cause balloon degeneration.

[0225] The bridging portion 1106 of the covering element 1100 (FIG. 20) prevents such obstruction of the artificial heart valve's advance over the balloon. For example, the bridging portion 1106 can act as a barrier against the folds of the balloon, thereby preventing the balloon folds from being captured on the strut interface 510 at the inflow end. More specifically, as the artificial heart valve slides over the top of the balloon, the bridging portion 1106 can contact the folds of the balloon and deflect these folds radially inward relative to the strut interface 510, allowing the valve to slide relatively smoothly over the balloon.

[0226] In addition, at the anterior edge (e.g., the inflow end) of the artificial heart valve, a smoother material of the covering element 1100 can further promote proper alignment of the artificial heart valve above the balloon and / or reduce resistance.

[0227] Instead of or excluding the cover element, the top region or top of the frame (such as the top region at the inlet end of the frame) may be polymer dip-coated or overmolded to form a circular cover layer over and / or around the top region or top. Because polymer materials are softer and more flexible than most metals, such dip-coated or overmolded covers may not affect the radial compression or expansion of the frame.

[0228] Figures 25 and 26 illustrate another example of a covering element for the top or top region of a frame 1400 for an artificial heart valve. More specifically, Figures 25 and 26 illustrate an example in which the covering element is assembled to be a valve that surrounds and covers the lateral edge 1410 (or perivalvular seal) of the artificial heart valve for the corresponding top or top region 1402 of the frame 1400. The frame 1400 may include a plurality of interconnected and angled struts 1406 and a plurality of top regions 1402 at the inlet (or first) end 1404 of the frame 1400. The frame 1400 may be any of the frames described herein, such as frame 300 of Figure 5, frame 400 of Figures 9A to 9C, or frame 500 of Figures 10A to 10C.

[0229] In some embodiments, the side edge 1410 (e.g., a fabric side edge) may be configured around the surface of the frame 1400 and may include lobes 1412 extending distally from a first edge 1414 of the side edge 1410. As shown in Figures 25 and 26, the first edge 1414 of the side edge 1410 may be an inflow edge attached to an inflow end 1404 of the frame 1400. The lobes 1412 of the side edge 1410 may be spaced apart from each other around the circumference of the side edge 1410.

[0230] In some instances, the side edge 1410 may be an annular side edge. In some instances, the side edge 1410 may comprise one or more side edge portions connected together and / or individually connected to one or more of the frame 1400. The side edge 1410 may comprise a fabric or polymer material, such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc.

[0231] In some instances, the side edge 1410 may include a plurality of lobes 1412, which may include one lobe 1412 for each top region 1402 of the inflow end 1404 of the frame 1400.

[0232] Each petal 1412 may be assembled to cover the corresponding top region 1402. For example, each petal 1412 may have a width 1416, which is selected such that it covers at least a portion of the top region 1402 or, in some cases, the entire top region. However, in some instances, the width 1416 may be selected such that it does not cover the entire inflow pillar 562 to which the top region 1402 is a part.

[0233] Furthermore, the plurality of flaps 1412 may extend from the first edge 1414 of the lateral edge 1410 and be configured along the first edge 1414 such that each flap 1412 is aligned with the corresponding top region 1402 when the lateral edge 1410 is fastened to the support of the frame 1400 (as shown in FIG25). Thus, each flap 1412 may be folded over the corresponding top region 1402 and the inlet end 1404 of the frame 1400 and fastened thereto by one or more sutures 1408 (or other fasteners, ultrasonic welding and / or other components for fastening), thereby covering the top region 1402 in a manner that conceals the top region 1402 and protects the inner wall of the delivery sheath from contact with the top region 1402 during navigation of the artificial heart valve through the delivery sheath to the implantation site.

[0234] In some instances, as shown in Figures 25 and 26, the side edge 1410 may be an inner side edge disposed around the inner surface 1420 of the frame 1400 (radially inward relative to the central longitudinal axis of the frame 1400). Thus, the petal 1412 may extend from the inner surface 1420 below the corresponding top region 1402 (at the inlet end 1404) and around the outer surface 1422 of the frame 1400 (Figure 26). A suture 1418 (the suture shown in Figure 26) may extend around the top region 1402 through a first portion 1424 of the petal 1412 disposed above the inner surface 1420 of the top region 1402, and around and / or through a second portion 1426 of the petal 1412 disposed above the outer surface 1422 of the top region 1402 (Figure 26). For example, in Figure 26, the suture 1418 is shown as surrounding the second portion 1426 of the petal 1412. However, in an alternative instance, the suture 1418 may additionally or alternatively extend through the second portion 1426 of the flap 1412.

[0235] In other embodiments, the side edge 1410 may be an outer edge configured around the outer surface 1422 of the frame 1400. Thus, the petal 1412 may cover the inner surface 1420 of the frame 1400 from the outer surface 1422 below the corresponding top region 1402 (at the inflow end 1404).

[0236] Although the lateral edge 1410 is shown in Figures 25 and 26 as covering the narrower top region 1402 of the frame 1400, in other instances, the valve 1412 of the lateral edge 1410 may be configured to surround and cover any type of inflow tip or top region of the frame of the artificial heart valve (e.g., a square or pointed tip, such as the top 220 of the frame 200 in Figure 3).

[0237] It should be noted that, for illustrative purposes, FIG26 is schematic and therefore shows small gaps between components (e.g., frame 1400 and side edge 1410 and / or side edge 1410 and top region 1402) to make it easier to distinguish different components. However, in some instances, such gaps may be smaller than the gaps shown, or there may be very small gaps or no gaps between certain components (e.g., seam 1418 and petal 1412). Furthermore, although FIG26 depicts petal 1412 as having more square corners (due to the covering), in some instances, petal 1412 may have a more rounded and flexible covering shape (e.g., due to its inclusion of fabric or polymer material).

[0238] The lateral edge of the valve containing the tip or tip region, which is assembled to cover the end of the frame of the artificial heart valve (e.g., the anterior end of the valve during the advance of the radially compressed artificial heart valve through the delivery sheath to the implantation site, which in some instances may be the inflow end) can prevent the tip or tip region from penetrating and / or damaging the inner wall of the delivery sheath, and reduce the driving force required for the artificial heart valve delivery device to advance through the delivery sheath.

[0239] Further details and examples of a buffer or covering element assembled to cover at least a portion of one or more of the tops of an artificial heart valve can be found in International Patent Application No. PCT / US2020 / 044994, filed August 5, 2020, which claims the benefit of U.S. Provisional Application No. 62 / 886,677, filed August 14, 2019.

[0240] As described above, a frame for an artificial heart valve that includes a narrowed tip region (extending to at least 25% of the length of the inflow or outflow struts containing the tip region) can reduce the maximum stress experienced by the frame during frame expansion and move away from the maximum stress in the tip region, thereby increasing the stability and lifespan of the frame. Furthermore, a tip region having a single continuous curved surface curving between corresponding angled strut portions of the inflow or outflow struts and forming an angle between 120 and 140 degrees between two angled strut portions can produce a tip region with a minimum axial height (e.g., equal to the width of the tip region), thereby allowing the leaflet tip edge portion of the artificial heart valve to be positioned closer to the inflow end of the frame and increasing the axial height of the first row of units located at the outflow end of the frame, thereby providing a larger open space at the outflow end of the frame (not obstructed by leaflet fusion and outflow edges) for increased blood flow and coronary artery access. Additionally, the frame including the tip region defining this larger angle (e.g., greater than 120 degrees and at most 140 degrees) can have reduced radial bounce after the artificial heart valve is radially expanded following deflation of the balloon of the delivery device. Furthermore, such tip regions can be less damaged and have less interaction with the balloon and / or delivery sheath of the delivery device when the artificial heart valve is mounted on the delivery device and navigated to the target implantation site.

[0241] In another example, strain concentration and / or maximum stress (such as those shown in Figures 5 and 6) experienced at the top of a frame with a thinned region or a reduced height of the top region can be reduced by creating a bump or protrusion at the central portion (or center) of the top. As described in more detail below, this bump can, for example, reinforce the center of the top and distribute strain between the thinner regions of the top on both sides of the bump, thereby reducing the likelihood of material degradation due to the high strain experienced during bending at the top during the expansion of the frame.

[0242] Figures 16A and 16B show exemplary examples of a portion of a frame 900 for an artificial heart valve, wherein the frame 900 may be similar to the frame 300 of Figures 5 and 6, except for the configuration of the top. For example, the frame 900 may include interconnecting struts 302 forming tops (or top regions) 902 at the inlet and outlet ends 904 of the frame 900 (shown in Figures 16A and 16B). Similar to the frame 300 of Figures 5 and 6, each top 902 is positioned between two angled struts 310 at the inlet or outlet end 904 of the frame 900 (Figures 16A and 16B) and forms a transition area therebetween. A detailed view of a single top 902 is shown in Figure 16B.

[0243] Each tip 902 may include a curved or relatively flat outer surface 906 (axially facing the outflow end 904) and an arcuate or curved inner surface 914 (axially facing the inflow end) disposed opposite to the outer surface 906. Compared to the single recess of the tip 304 in Figures 5 and 6, the inner surface 914 of each tip 902 (Figure 16A) includes two curved recesses, including a first recess 908 and a second recess 910 separated from each other by a protrusion 912 (Figure 16B). In this way, at the tip 902, the inner surface 914 of the support generally includes an "M" shape.

[0244] As shown in FIG16B, the protrusion 912 may protrude axially away from the first recess 908 and the second recess 910. Furthermore, the protrusion 912 may be positioned in the central region or center of the tip 902, as indicated by the central longitudinal axis 916 in FIG16B. For example, the peaks of the tip 902 and the protrusion 912 (which extend in opposite axial directions) may be aligned along the central longitudinal axis 916.

[0245] The first recess 908 and the second recess 910 may create a thinned region of the tip 902 (on either side of the protrusion 912) having a width (or height) 920 smaller than the width 318 of the angled support 310 (FIG. 16B). In some instances, the width 920 may be the same as or similar to the width 316 of the recess 314 within the tip 304 of the frame 300 (FIG. 6). However, the region of the tip 902 at the protrusion 912 may have a width 922 (FIG. 16B) greater than the width 920 of the first recess 908 and the second recess 910. In some instances, the width 922 is still smaller than the width 318 of the angled support 310.

[0246] In some instances, the difference between the height of the bump 912 and the width 922 and the width 920 may be on the order of micrometers, and therefore invisible to the naked eye. The bump 912 shown in Figure 16B is slightly exaggerated for illustrative purposes (and may actually be smaller than the bump shown in Figure 16B).

[0247] In some instances, the first recess 908 and the second recess 910, as well as the protrusion 912, may be laser-formed. In some instances, the protrusion 912 may be within the dimensional tolerances of the support (±0.025 mm) and may be formed by increasing the resolution of the laser beam at the tip region (e.g., tip 902) where the protrusion 912 is formed. In addition to the regular ±0.025 mm tolerance, a local tolerance is provided for the width difference between the reference width 922 and the width 920, thus locally following the cutting curve. In some cases, this tolerance may be about an order of magnitude tighter than the regular tolerance (e.g., 0.0025 mm, or in other cases 1 to 10 µm). Thus, in some instances, the width difference between the width 922 and the width 920, and therefore the height of the protrusion 912, may be 25 µm ± 2.5 µm. In some instances, the height of bump 912 can range from 10 to 50 µm or from 20 to 30 µm.

[0248] In some instances, since the struts of frame 900 may have substantially rectangular cross-sectional shapes, their moment of inertia I = (1 / 12)bh³ (where "h" refers to the axial height, which may be the same as the width mentioned above, and "b" refers to the radial thickness), the stress generated during bending at the top 902 is proportional to the bending moment divided by the moment of inertia. Therefore, a small increase in the height (or width) of the strut substantially affects the stress / strain (cubic power) generated at the top 902 (or other areas of the strut).

[0249] Therefore, the shape of the protrusion 912, which increases the width 922 (or height) at the center of the tip 902, reduces the strain generated in the central region of the tip 902, while the maximum strain is distributed on either side of the protrusion 912 to the adjacent thinned regions of the tip 902 (at the first recess 908 and the second recess 910). This, in turn, significantly reduces the strain at the reduced height tip 902, thereby allowing the tip 902 to withstand bending forces (e.g., during the radial expansion of the frame 900) without experiencing material degradation.

[0250] As explained above, in some instances, the frame of the artificial heart valve may include an axial strut (e.g., axial strut 232) with an increased width relative to the width of the angled struts of the frame (including the angled struts to which the axial struts are connected and extend therebetween). Therefore, a larger contact area is provided when the leaflet of the artificial heart valve contacts the wider axial strut during contraction, thereby distributing stress and reducing the extent to which the leaflet may fold radially outward through the frame unit above the axial strut. Thus, as an example, the long-term durability of the leaflet of the artificial heart valve can be improved.

[0251] In some cases, widened axial struts can cause coronary artery access problems after valve-in-valve surgery. For example, in some cases, a second artificial heart valve may be implanted within a previously implanted first artificial heart valve. After such valve-in-valve implantation, the axial struts of the first and second artificial heart valves may be positioned close to each other (e.g., adjacent). If coronary artery access requires a coronary artery access catheter and access is blocked by the adjacent axial struts of the first and second artificial heart valves, the balloon catheter is typically advanced between the adjacent axial struts of the first and second artificial heart valves and inflated to laterally and outwardly expand or bend the axial struts, thereby creating a larger opening for coronary artery access. However, the widened axial struts disclosed herein can lead to increased resistance to the inflatable balloon, and in some cases, the adjacent axial struts may not be able to dissociate to allow coronary artery access.

[0252] To improve coronary artery access, artificial heart valves with wider axial struts may also include multiple lateral slits (or notches) along the axial length of the axial strut. Figure 17 shows an exemplary widened axial strut 1000 having a lateral width 1022 and including one or more slits 1002. In some instances, as shown in Figure 17, one or more slits 1002 include multiple slits 1002. As described above, in some instances, the width 1022 of the axial strut 1000 may range from 0.45 mm to 1.0 mm, 0.5 mm to 0.75 mm, or at least 0.6 mm.

[0253] The axial strut 1000 may be coupled to and extend between the angled struts 1004 of the artificial heart valve. The axial length 1006 of the axial strut 1000 may be defined between the point where the lower ends of the two angled struts 1004 converge and the point where the upper ends of the other two angled struts 1004 converge. The slits 1002 may be spaced apart from each other along the axial length 1006 of the axial strut 1000.

[0254] In some instances, the slits 1002 may be divided into groups (e.g., pairs) 1016 of slits 1002 spaced apart from each other along an axial length 1006, wherein there is a small amount of space (in the axial direction) between the slits 1002 included in the same group, thereby creating one or more solid or slitless portions 1008 (e.g., portions not containing slits 1002) in the axial strut 1000. In other words, each group 1016 may be spaced apart from adjacent groups 1016 along the length 1006 of the axial strut 1000 by an amount or spacing greater than the spacing between the slits 1002 within the same group 1016.

[0255] In other instances, the plurality of slits 1002 of the axial strut 1000 may be equidistant from each other along the axial length 1006.

[0256] In some instances, the axial spacing or distance between slits 1002 within the same group 1016 may vary (e.g., may be less than or greater than the axial spacing or distance shown in FIG17).

[0257] In some embodiments, the axial strut 1000 may include a first lateral edge 1010, a second lateral edge 1012, and a radially inward surface 1014 extending between the first lateral edge 1010 and the second lateral edge 1012. Each slit 1002 may extend laterally (or circumferentially) from one of the first lateral edge 1010 and the second lateral edge 1012 into the axial strut 1000 and toward the other of the first lateral edge 1010 and the second lateral edge 1012. In this way, each slit 1002 may extend through a portion of the width 1022 of the axial strut 1000 (e.g., only through that portion and not through the entire width 1022).

[0258] For example, a first portion of slit 1002 (e.g., one slit of each pair or group 1016) may extend from the first lateral edge 1010 toward the second lateral edge 1012 into the axial support 1000, wherein the closed end 1018 of slit 1002 is spaced (laterally) from the second lateral edge 1012 by a distance 1020. Similarly, a second portion of slit 1002 (e.g., one slit of each pair or group 1016) may extend from the second lateral edge 1012 toward the first lateral edge 1010 into the axial support 1000, wherein the closed end 1018 of slit 1002 is spaced (laterally) from the second lateral edge 1012 by a distance 1020. In some instances, the distance 1020 may be in the range of 0.1 to 0.3 mm and the width 1022 may be in the range of 0.5 to 1.0 mm.

[0259] In some instances, the distance 1020 and therefore the width (in the lateral direction) of each slit 1002 may vary for slits in the same axial strut 1000 and / or for different axial struts. The width of the slit 1002 may be the difference between the width 1022 of the axial strut 1000 and the distance 1020. As an example, in one case, the first slit 1002 may have a first width and the second slit 1002 of the same axial strut 1000 may have a second width, which is smaller than the first width (and therefore, the distance 1020 will be larger for the second slit than the first slit). In other instances, the width of each slit 1002 in the axial strut 1000 may be the same (and therefore, the distance 1020 will be the same for each slit 1002).

[0260] Each slit 1002 may have an axial height 1024 ranging from 0.075 to 0.3 mm. In some instances, all slits 1002 in the axial strut 1000 may have the same height 1024. In other instances, one or more of the slits 1002 in the axial strut 1000 may have a different height (smaller or larger) than the other slits 1002 in the axial strut 1000.

[0261] In some instances, the slit 1002 is formed in the axial support 1000 by laser (e.g., by laser cutting).

[0262] The slit 1002 may be referred to as a release slit and may be configured to improve the compliance (e.g., flexibility) of the axial strut 1000 such that when the balloon of the balloon catheter inserted between the adjacent axial struts of the two (concentrically implanted) artificial heart valves is inflated between the adjacent axial struts, the adjacent axial struts bend laterally outward and away from each other, thereby creating space therebetween for coronary artery access. For example, as shown in FIG18, during valve-in-valve surgery, the second (object) artificial heart valve 1030 may be inserted, radially expanded, and implanted within the initially implanted first (body) artificial heart valve 1032. The first axial strut 1034 of the first artificial heart valve 1032 may be positioned close to and adjacent to the second axial strut 1036 of the second artificial heart valve 1030 (both the first axial strut 1034 and the second axial strut 1036 are identical to the axial strut 1000).

[0263] If the first axial strut 1034 and the second axial strut 1036 obstruct the entry of the coronary artery (e.g., due to their positioning anterior to the opening of the coronary artery and their proximity to each other), a balloon catheter may be positioned between the first axial strut 1034 and the second axial strut 1036, and the balloon 1038 of the balloon catheter may be inflated. When the balloon 1038 is inflated and pressure is applied against the lateral edges of the first axial strut 1034 and the second axial strut 1036, the first axial strut 1034 and the second axial strut 1036 bend outward in opposite directions due to their slits 1002. Thus, the first axial strut 1034 and the second axial strut 1036 bend (or buckle) away from each other, thereby creating space between the first axial strut 1034 and the second axial strut 1036 for the coronary artery to enter.

[0264] By extending the slit 1002 from both the lateral edges (sides) of the axial strut 1000, the axial strut 1000 can be bent in either of two (lateral or circumferential) directions, depending on which side of the axial strut 1000 the balloon is located on. For example, as shown in FIG18, the first axial strut 1034 is bent in a first direction 1040 and the second axial strut 1036 is bent in the opposite second direction 1042.

[0265] The axial struts of any of the artificial heart valves described herein can be assembled as the same as or similar to the axial struts 1000 of Figures 17 and 18. For example, as shown in Figure 19, the axial struts 232 of the frame 500 (Figures 10A to 12) may include the plurality of slits 1002. In some instances, as shown in Figure 19, a first group 1044 of slits may be disposed in the wider outflow portion 246 of the axial strut 232, a second group 1048 of slits may be disposed in the narrower middle portion 247 of the axial strut 232, and a third group 1050 of slits may be disposed in the wider inflow portion 248 of the axial strut 232.

[0266] In some instances, as shown in FIG19, the width (in the lateral direction) of slit 1002 in the first group 1044 and the third group 1050 of slits may be greater than the width of slit 1002 in the second group 1048 of slits. Therefore, the distance between the closed end of slit 1002 and the lateral edge of the axial support (e.g., distance 1020 shown in FIG17) may be the same or similar for all slits 1002. In other instances, the width of slit 1002 may be the same for all groups 1044, 1048, and 1050.

[0267] In other examples, all the slits 1002 in the axial strut 232 may be located in the intermediate portion 247, without any slits in the wider outflow portion 246 and inflow portion 248.

[0268] Although the examples of Figures 17 to 19 show six slots 1002 in each axial strut, in other examples each axial strut may contain more or fewer than six slots 1002 (e.g., four, five, eight or the like). In some examples each axial strut may include only one slot 1002.

[0269] However, in some instances, it may be advantageous to have three groups of two slits 1002 (a total of six slits 1002, as shown in the examples of Figures 17 to 19), wherein two slits in the same group extend in opposite lateral directions. For example, this configuration provides three bending points in each direction (lateral direction), thereby allowing the axial strut 1000 to bend in either of the two lateral directions (e.g., depending on which side of the axial strut is subjected to the lateral force from the inflatable balloon).

[0270] Additionally, in some instances, the slit 1002 may have a shape different from those shown in Figures 17 to 19, such as a triangle, square, cone, or similar shape (compared to an ellipse or rectangle with a curved closed end). Furthermore, as mentioned above, the width and height of the slit 1002 may vary.

[0271] As described above, the frame may have axial struts that are wider than the angled struts to which it is connected. The axial struts may include non-connecting window axial struts (e.g., axial strut 232) and axially extending struts that define the connecting window therein (including axially extending window strut portions, such as axially extending window strut portion 240). Higher stress areas may form in the transition zone between the narrower angled struts and the wider axial struts (or axially extending window strut portions). Specifically, higher stress areas may appear at the root or bottom of the angled struts at the outflow end of the frame, where the root of the angled strut bends outward (convexly) to the greater width of the axial struts. These higher stress areas may be exacerbated at the connecting window axial struts due to the higher loads these struts experience during operation of the artificial heart valve (e.g., because the leaflet commissure is directly attached to the connecting window defined by the axially extending window strut portion of the axial strut). Therefore, it is necessary to strengthen the frame in these areas to improve the frame's durability.

[0272] As an example, the stress experienced in these transition regions can be reduced by adding concave regions (or recesses that may create narrowing regions) at the axially extending window strut portions and / or the end portions of the axial struts, thereby strengthening the frame, which is directly connected to the root or bottom of the angled struts of the frame. Examples of such concave regions applied to an exemplary frame 1600 for an artificial heart valve are shown in Figures 30 and 31. Although Figures 30 and 31 depict frame 1600, which may be similar to frame 400 or frame 500 described above, the concave regions described below with reference to Figures 30 and 31 can be applied to various artificial heart valve frames, including any of the frames described herein.

[0273] Turning first to FIG. 30, the frame 1600 may include multiple rows of angled struts 1602, including a first row of angled struts 1602a forming the outflow end 1604 of the frame 1600. The frame 1600 may include a top region 1606 (or a top in other instances, such as the tops shown in FIG. 1, FIG. 3 and FIG. 5) formed at the outflow end 1604 and the inflow end 1608 of the frame 1600. The frame 1600 may also include a plurality of axial struts 1610 (one of which is shown in FIG. 30) defining the connecting window 1612 therein. For example, each axial strut 1610 may include a first window strut portion 1614a and a second window strut portion 1614b, which define the connecting window 1612 and form an upper (outflow) end portion 1616 above the connecting window 1612 (or further toward the outflow end 1604) and a lower (inflow) end portion 1618 below the connecting window 1612 (or further toward the inflow end 1608). The lower end portion 1618 may be connected to the angled strut 1602b of the second column and the upper end portion 1616 may be connected to the angled strut 1602a.

[0274] In some instances, as shown in FIG30, a concave region 1620 (which may be formed or continued as a thinned or narrowed region along the axial strut) may be formed in the upper portion 1616 at the root or bottom of the angled strut 1602a to which it is connected. Specifically, the transition region 1632 between the angled strut 1602a and the axial strut 1610 may include three variations of concavity that produce lower stress at the bottom of the angled strut 1602a, wherein the angled strut 1602a is connected to the upper portion 1616 of the axial strut 1610. The three variations of concavity include a first concave surface 1634 (or concave region) that transitions to a first convex surface 1636 (or convex region) and then to a second concave surface 1635 forming the concave region 1620. A fourth change in concavity can occur at the bottom of the upper portion 1616, as illustrated by the second convex surface 1638 transitioning back to the wider portion of the axial strut 1610. Thus, a more gradual transition zone can be created between the narrower angled strut 1602a and the wider portion 1624 (with a wider width 1628) of the axial strut 1610. Therefore, the maximum stress experienced at the transition region 1632 or at the bottom or root of the angled strut 1602a can be reduced, thereby improving the durability of the frame 1600.

[0275] In some cases, each upper portion 1616 of each axial strut 1610 may include two concave regions 1620 (or recesses) at the bottom of the angled strut 1602a, with one concave region on each side of the upper portion 1616. Therefore, a narrowed region 1622 with a narrower width 1626 is created adjacent to the angled strut 1602a in the upper portion 1616. For example, the width 1626 of the narrowed region 1622 may be greater than the width 1630 of the angled strut 1602a but less than the width 1628 of the wider portion 1624 of the axial strut 1610.

[0276] In some instances, the lower portion 1618 may also include a concave region 1620, thereby creating a more gradual transition zone between the wider portion 1624 of the axial strut 1601 and the angled strut 1602b.

[0277] Figure 31 shows another example of a concave region 1640 that may be formed in the upper portion 1616 at the bottom or root of the angled strut 1602a. The concave region 1640 may be formed at the bottom of the angled strut 1602a to extend circumferentially into or recess into the upper portion 1616. In some cases, as shown in Figure 31, the concave region 1640 may be formed adjacent to a convex surface 1644 in the bottom of the angled strut 1602a, which is adjacent to another concave surface 1646 in the angled strut 1602a. In addition, in some cases, the concave region 1640 may transition to another convex surface 1648 in the axial strut 1610.

[0278] At least three variations in concavity between the concave surface 1646, the convex surface 1644, and the concave region 1640 (and optionally a fourth variation in concavity at the concave surface 1646) can generate reduced stress at the bottom of the angled strut 1602a, which is connected to the axial strut 1610. Although only one side of the axial strut is shown in FIG31, in some instances, the two sides of the upper portion 1616 may include the concave region 1640. Furthermore, in some cases, the lower portion 1618 of the axial strut 1610 may also include the concave region 1640 at the bottom of the angled strut 1602b (similar to that shown in FIG30).

[0279] In some instances, the concave region 1640 of FIG31 or the concave region 1620 of FIG30 may be included only on the axial strut (at the bottom of the angled strut to which it is connected) that defines the joined window (e.g., the axially extending window strut portion described herein).

[0280] In an alternative embodiment, the concave region 1640 of FIG. 31 or the concave region 1620 of FIG. 30 may be included on all axial supports of the frame at the bottom of the angled support to which it is connected, including axial supports forming joined windows and axial supports forming non-joined windows (e.g., axial support 232). Conveying technology

[0281] To implant an artificial valve into the native aortic valve via a femoral artery delivery method, the artificial valve is installed in a radially compressed state along the distal portion of the delivery device. The artificial valve and the distal portion of the delivery device are inserted into the femoral artery and advanced into the descending aorta, passing through the descending aorta, around the aortic arc, and through the ascending aorta. The artificial valve is positioned within the native aortic valve and expands radially (e.g., by inflating a balloon, actuating one or more actuators of the delivery device, or by deploying the artificial valve with a self-sheath to allow the artificial valve to expand spontaneously). Alternatively, the artificial valve may be implanted into the native aortic valve during apical surgery, thereby introducing the artificial valve (on the distal portion of the delivery device) into the left ventricle through a surgical incision in the chest and the apex of the heart, and positioning the artificial valve within the native aortic valve. Alternatively, in apical surgery, an artificial valve (on the distal portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, such as via a partial J-sternotomy or a small right parasternal thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0282] To implant an artificial valve into the native mitral valve via a transseptal delivery method, the artificial valve is installed in a radially compressed state along the distal portion of the delivery device. The artificial 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, across the atrial septum (through a perforation created in the atrial septum), into the left atrium, and towards the native mitral valve. Alternatively, the artificial valve can be implanted into the native mitral valve during apical surgery, thereby introducing the artificial valve (on the distal portion of the delivery device) into the left ventricle through a surgical incision in the chest and the apex of the heart, and positioning the artificial valve within the native mitral valve.

[0283] To implant an artificial valve into the native tricuspid valve, the artificial valve is installed in a radially compressed state along the distal portion of the delivery device. The artificial 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 then into the right atrium, with the artificial valve positioned within the native tricuspid valve. A similar method can be used to implant an artificial valve into the native pulmonary valve or pulmonary artery, except that the artificial valve advances through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0284] Another delivery method is the transatrial method, in which the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and an incision made through the atrial wall (right or left atrium) to allow entry into either of the native heart valves. Atrial delivery can also be performed intravascularly, such as via the pulmonary vein. Yet another delivery method is the transventricular method, in which the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (usually at or near the base of the heart) to allow implantation of the prosthetic valve into the native tricuspid valve, native pulmonary valve, or pulmonary artery.

[0285] In all delivery methods, the delivery device can advance above a guideline previously inserted into the patient's vascular structure. Furthermore, the disclosed delivery methods are not intended to be limited. Any of the artificial valves disclosed herein can be implanted using any of the various delivery procedures and delivery devices known in this technology. Additional examples of the disclosed technology

[0286] In view of the implementation described above, this application discloses additional examples listed below. It should be noted that a single morphological element of an example or an example combined with one or more other morphological elements of another example, or more morphological elements arbitrarily combined, are also examples within the scope of the disclosure of this application.

[0287] Example 1. An artificial heart valve comprising: a radially expandable and compressible annular frame including: a plurality of interconnected struts defining a plurality of rows of units disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts including a plurality of outflow struts defining an outflow end and a plurality of inflow struts defining an inflow end, wherein each outflow strut includes two angled strut portions interconnected by a apical region, and wherein each inflow strut includes two angled strut portions interconnected by a apical region; wherein each apical region bends between a corresponding pair of two angled strut portions, wherein each apical region has a narrowed width and a length extending at least 25% of the total length of the outflow struts or inflow struts, and wherein the narrowed width is less than the width of the two angled strut portions.

[0288] Example 2. As in any example herein, specifically Example 1, of the artificial heart valve, wherein each outflow strut forms an outflow edge of a unit in a first row of units at the outflow end, and wherein each inflow strut forms an inflow edge of a unit in a second row of units at the inflow end.

[0289] Example 3. As in any example herein, specifically the artificial heart valve of Example 2, wherein the unit in the first column has a longer axial length relative to the central longitudinal axis of the frame than the unit in the second column.

[0290] Example 4. As in any example herein, specifically the artificial heart valve of Example 3, wherein the plurality of interconnecting struts further comprises a plurality of axial struts extending in the direction of a central longitudinal axis and spaced apart from each other around the circumference of the frame, wherein each axial strut forms the axial side of two adjacent units in the first column of units, and wherein each axial strut has a width greater than the width of the angled struts of the plurality of interconnecting struts.

[0291] Example 5. As in any example herein, specifically Example 4, an artificial heart valve, wherein for each axial strut, the width of the axial strut is the width of the middle portion of the axial strut and wherein each axial strut includes a lower end portion and an upper end portion disposed on opposite sides of the middle portion, the lower end portion including a pore.

[0292] Example 6. As in any example herein, specifically the artificial heart valve of Example 5, further includes an outer edge disposed on the outer surface of the frame, surrounding the circumference of the frame and fastened to a portion of one of the plurality of interconnected struts, wherein the outflow end of the outer edge is fastened to a hole in each axial strut.

[0293] Example 7. As in any example herein, specifically the artificial heart valve of Example 6, wherein the lateral edge extends from the inflow end of the frame toward the outflow end and close to the lower end portion of each axial strut.

[0294] Example 8. As in any example herein, specifically any of Examples 1 to 7, wherein each apical region forms an angle greater than 120 degrees and at most 140 degrees between two angled strut portions of the corresponding outflow strut or inflow strut.

[0295] Example 9. An artificial heart valve, as in any example herein, specifically any of Examples 1 to 8, wherein each apical region includes a curved outer surface having a radius of curvature greater than 1 mm, the curved outer surface extending between the outer surfaces of two angled strut portions corresponding to the outflow strut or inflow strut.

[0296] Example 10. As in any example herein, specifically any of Examples 1 to 9, wherein the length of each apical region is in the range of 0.9 mm to 2.2 mm.

[0297] Example 11. As in any example herein, specifically any of Examples 1 to 9, wherein the length of each apical region is in the range of 1.9 mm to 2.2 mm.

[0298] Example 12. An artificial heart valve, as in any example herein, specifically any of Examples 1 to 9, wherein the length of each apical region at the outflow end is in the range of 1.8 mm to 2.4 mm and the length of each apical region at the inflow end is in the range of 0.8 mm to 1.2 mm.

[0299] Example 13. The artificial heart valve of any of Examples 1 to 12, as in any example herein, wherein the narrowed width of each apical region is 0.06 mm to 0.15 mm smaller than the width of the two angled strut portions.

[0300] Example 14. An artificial heart valve, as in any example herein, specifically any of Examples 1 to 13, wherein the width of the angled strut portion is 0.3 mm and the narrowed width of each apical region is in the range of 0.15 mm to 0.24 mm.

[0301] Example 15. An artificial heart valve, as in any example herein, specifically any of Examples 1 to 14, wherein each apical region includes a curved axially outward surface that is continuous with the axially outward surface of the two angled strut portions of the corresponding outward or inward strut, and an arcuate axially inward recess that recesses from the axially inward surface of the two angled strut portions toward the outer surface of the apical region.

[0302] Example 16. An artificial heart valve, as in any example herein, specifically any of Examples 1 to 15, wherein one or more of the apical regions are twisted about a transverse axis of the apical region such that the apical region comprises an assembled, undamaged twisted outer surface.

[0303] Example 17. As in any example herein, specifically any of Examples 1 to 16, the artificial heart valve further comprises a plurality of leaflets fastened to a frame.

[0304] Example 18. As in any example herein, specifically the artificial heart valve of Example 17, further comprises a plurality of fused windows formed by the struts of the plurality of interconnecting struts of the units forming the first column of the plurality of units, the first column of units being disposed at the outflow end of the frame, and wherein each fused window is configured to receive a fused flap of two adjacent leaflets of the plurality of leaflets.

[0305] Example 19. As in any example herein, specifically Example 18, an artificial heart valve, wherein each synaptic window is spaced apart by an upper axial strut extending between an interface between two adjacent outflow struts and an axially extending window strut portion defining the synaptic window and the outflow end of the frame.

[0306] Example 20. As in any example herein, specifically Example 17, an artificial heart valve, wherein each fusion window is defined by an axially extending window strut portion forming an upper portion above the fusion window and a lower portion below the fusion window, wherein the length of the upper and lower portions in the axial direction relative to the central longitudinal axis of the frame is greater than the width of the two angled strut portions.

[0307] Example 21. An artificial heart valve comprising: a radially expandable and compressible annular frame including a plurality of interconnected struts defining a plurality of rows of units disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts including a plurality of outflow struts defining an outflow end and a plurality of inflow struts defining an inflow end, wherein each of the plurality of outflow struts and the plurality of inflow struts includes: two angled strut portions; and a top region disposed between the two angled strut portions, the top region including a curved axially outward surface forming a single curved surface between the axially outward surfaces of the two angled strut portions and an axially inwardly recessed surface concave from the axially inwardly facing surfaces of the two angled strut portions toward the curved outer surface of the top region, such that the width of the top region is less than the width of the two angled strut portions.

[0308] Example 22. As in any example herein, specifically Example 21, the artificial heart valve has a radius of curvature greater than 1 mm on the curved outer surface of the apical region.

[0309] Example 23. As in any example herein, specifically the artificial heart valve of Example 21, wherein the radius of curvature of the curved outer surface of the apical region is in the range of 8 mm to 14 mm.

[0310] Example 24. The artificial heart valve of example 22 or 23, as in any example herein, wherein the curved outer surface is continuously curved at the radius of curvature from the outer surface of the first angled strut portion of the two angled strut portions on the first side of the top region to the second angled strut portion of the two angled strut portions on the second side of the top region.

[0311] Example 25. An artificial heart valve, as in any example herein, specifically any of Examples 21 to 24, wherein the apical region forms an angle greater than 120 degrees and less than or equal to 140 degrees between two angled strut portions.

[0312] Example 26. An artificial heart valve, as in any example herein, specifically any of Examples 21 to 24, wherein the apical region forms an angle between two angled strut portions in the range of 135 to 140 degrees.

[0313] Example 27. An artificial heart valve, as in any example herein, specifically any of Examples 21 to 26, wherein the apical region comprises an apex and two thinned strut portions, one thinned strut portion being disposed on either side of the apex, each thinned strut portion extending from the apex to a corresponding angled strut portion of the two angled strut portions, and wherein each thinned strut portion of the apical region has a length in the range of 0.8 mm to 1.4 mm.

[0314] Example 28. An artificial heart valve, as in any example herein, specifically any of Examples 21 to 27, wherein the apical region comprises an apex and two thinned strut portions, one thinned strut portion being disposed on either side of the apex, each thinned strut portion extending from the apex to a corresponding angled strut portion of the two angled strut portions, and wherein each thinned strut portion of the apical region has a length in the range of 0.95 mm to 1.05 mm.

[0315] Example 29. An artificial heart valve, as in any example herein, specifically any of Examples 21 to 28, wherein the plurality of units include a first row of units disposed at the outflow end of the frame and a second row of units disposed at the inflow end of the frame, and wherein the units in the first row of units have a longer axial length relative to the central longitudinal axis of the frame than the units in the second row of units.

[0316] Example 30. The artificial heart valve of Example 29, as in any example herein, wherein the plurality of interconnecting struts further comprises a plurality of axial struts extending in the direction of a central longitudinal axis and spaced apart from each other around the circumference of the frame, wherein each axial strut forms the axial side of two adjacent units in the first column of units, and wherein each axial strut has a width greater than the width of the angled struts of the plurality of interconnecting struts, the angled struts including the angled struts forming the units in the first column of units having axial struts.

[0317] Example 31. As in any example herein, specifically Example 30, the artificial heart valve, wherein the width of the axial strut is the width of the middle portion of the axial strut and wherein each axial strut includes a lower end portion and an upper end portion disposed on opposite sides of the middle portion, the lower end portion including a pore.

[0318] Example 32. As in any example herein, specifically the artificial heart valve of Example 31, further includes an outer edge disposed on the outer surface of the frame, surrounding the circumference of the frame and fastened to a portion of one of the plurality of interconnected struts, wherein the outflow end of the outer edge is fastened to a hole in each axial strut.

[0319] Example 33. An artificial heart valve, as in any example herein, specifically any of Examples 21 to 32, wherein the length of each apical region is in the range of 0.9 mm to 2.2 mm.

[0320] Example 34. An artificial heart valve, as in any example herein, specifically any of Examples 21 to 32, wherein the length of each apical region is in the range of 1.9 mm to 2.2 mm.

[0321] Example 35. An artificial heart valve, as in any example herein, specifically any of Examples 21 to 32, wherein the length of each apical region at the outflow end of the frame is in the range of 1.8 mm to 2.4 mm and wherein the length of each apical region at the inflow end of the frame is in the range of 0.8 mm to 1.2 mm.

[0322] Example 36. An artificial heart valve, as in any example herein, specifically any of Examples 21 to 35, wherein the width of the apical region is 0.06 mm to 0.15 mm smaller than the width of the two angled strut portions.

[0323] Example 37. An artificial heart valve, as in any example herein, specifically any of Examples 21 to 36, wherein the width of the angled strut portion is 0.3 mm and the width of the apical region is in the range of 0.15 mm to 0.24 mm.

[0324] Example 38. An artificial heart valve, as in any example herein, specifically any of Examples 21 to 37, wherein one or more of the apical regions are twisted about a transverse axis of the apical region such that the apical region comprises an assembled, undamaged twisted outer surface.

[0325] Example 39. The artificial heart valve of any of Examples 21 to 38, as in any example herein, further comprises a plurality of leaflets fastened to a frame, wherein each leaflet comprises opposing commissural flaps disposed on opposite sides of the leaflet and a valve tip edge portion extending between the opposing commissural flaps, and wherein the valve tip edge portion of each leaflet is disposed adjacent to the inflow end of the frame.

[0326] Example 40. As in any example herein, specifically Example 39, the artificial heart valve further comprises a plurality of fused windows formed by the struts of the plurality of interconnecting struts of the unit forming the first column of the plurality of units, the first column of units being disposed at the outflow end of the frame, and wherein each fused window is configured to receive a fused flap of each of two adjacent leaflets of the plurality of leaflets.

[0327] Example 41. As in any example herein, specifically Example 40, an artificial heart valve, wherein each synaptic window is spaced apart by an upper axial strut extending between an interface between two adjacent outflow struts and an axially extending window strut portion defining the synaptic window and the outflow end of the frame.

[0328] Example 42. As in any example herein, specifically Example 40, an artificial heart valve, wherein each fusion window is defined by an axially extending window strut portion forming an upper portion above the fusion window and a lower portion below the fusion window, wherein the length of the upper and lower portions in the axial direction relative to the central longitudinal axis of the frame is greater than the width of the two angled strut portions.

[0329] Example 43. As in any example herein, specifically any of Examples 21 to 42, the artificial heart valve further includes a cushioning element covering the curved outer surface of at least one apex of the apex region.

[0330] Example 44. An artificial heart valve comprising: a radially expandable and compressible annular frame including a plurality of interconnected struts defining a plurality of rows of units disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts including a plurality of outflow struts defining an outflow end and a plurality of inflow struts defining an inflow end, wherein each of the plurality of outflow struts and the plurality of inflow struts includes: two angled strut portions; and a top region disposed between the two angled strut portions, the top region including a top and two thinned strut portions extending outward in opposite directions from the top relative to the central longitudinal axis of the top region, wherein the width of the two thinned strut portions is less than the width of the two angled strut portions and the combined length of the two thinned strut portions is at least 25% of the length of the corresponding outflow strut or inflow strut including the top region.

[0331] Example 45. The artificial heart valve of Example 44, as in any example herein, wherein each outflow strut forms the outflow edge of a unit of the first row of units in the plurality of units and wherein each outflow strut is connected to at least one of the plurality of axial struts of the frame, the at least one axial strut extending axially relative to the central longitudinal axis and forming the axial side of the unit.

[0332] Example 46. As in any example herein, specifically Example 45, an artificial heart valve wherein the axial strut has a width greater than the width of the angled struts of the plurality of interconnected struts, the angled struts including angled struts forming a unit in the first column of units having the axial strut.

[0333] Example 47. The artificial heart valve of Example 46, as in any example herein, wherein the width of the axial strut is the width of the middle portion of the axial strut and wherein the axial strut includes a lower end portion and an upper end portion disposed on opposite sides of the middle portion, the lower end portion including a pore.

[0334] Example 48. As in any example herein, specifically the artificial heart valve of Example 47, further includes an outer edge disposed on the outer surface of the frame, surrounding the circumference of the frame and fastened to a portion of one of the plurality of interconnected struts, wherein the outflow end of the outer edge is fastened to a hole in the axial strut.

[0335] Example 49. As in any example herein, specifically any of Examples 44 to 48, the height of the top region defined by the axially facing outward surface of the two angled strut portions to the axially facing outward surface of the top region at the top is the width of the two thinned strut portions.

[0336] Example 50. An artificial heart valve, as in any of the examples herein, specifically any of Examples 44 to 49, wherein each of the two thinned strut portions in the apical region has a length in the range of 0.8 mm to 1.4 mm.

[0337] Example 51. An artificial heart valve, as in any example herein, specifically any of Examples 44 to 49, wherein each of the two thinned strut portions in the tip region of each outflow strut has a first length in the range of 0.95 to 1.05 mm and wherein each of the two thinned strut portions in the tip region of each inflow strut has a second length in the range of 0.45 to 0.55 mm.

[0338] Example 52. An artificial heart valve, as in any example herein, specifically any of Examples 44 to 51, wherein each apical region forms an angle greater than 120 degrees and at most 140 degrees between two angled strut portions.

[0339] Example 53. An artificial heart valve, as in any example herein, specifically any of Examples 44 to 52, wherein each apical region includes a curved axially outward-facing surface having a radius of curvature greater than 1 mm, the curved outer surface extending between the axially outward-facing surfaces of two angled strut portions.

[0340] Example 54. An artificial heart valve, as in any example herein, specifically any of Examples 44 to 53, wherein the width of the two thinned strut portions in each apical region is 0.06 mm to 0.15 mm smaller than the width of the two angled strut portions.

[0341] Example 55. An artificial heart valve, as in any example herein, specifically any of Examples 44 to 53, wherein the width of the two angled strut portions is 0.3 mm and the width of the two thinned strut portions in each apical region is in the range of 0.15 mm to 0.24 mm.

[0342] Example 56. An artificial heart valve, as in any example herein, particularly any of Examples 44 to 55, wherein each apical region includes a curved axially facing outward surface and an arcuate axially facing inward recess of two thinned strut portions forming the apical region, wherein the curved outward surface is continuous with the axially facing outward surface of the two angled strut portions, and wherein the inward recess is recessed from the axially facing inward surface of the two angled strut portions toward the curved outward surface.

[0343] Example 57. An artificial heart valve, as in any example herein, particularly any of Examples 44 to 55, wherein one or more of the apical regions are twisted about a transverse axis of the apical region such that the apical region comprises an assembled, undamaged twisted outer surface.

[0344] Example 58. As in any example herein, specifically any of Examples 44 to 56, the artificial heart valve further comprises a plurality of leaflets fastened to a frame.

[0345] Example 59. As in any example herein, specifically the artificial heart valve of Example 58, further comprises a plurality of fused windows formed by the struts of the plurality of interconnecting struts of the units forming the first column of the plurality of units, the first column of units being disposed at the outflow end of the frame, and wherein each fused window is configured to receive a fused flap of two adjacent leaflets of the plurality of leaflets.

[0346] Example 60. The artificial heart valve of Example 59, as in any example herein, wherein each synaptic window is spaced apart by an upper axial strut extending between the interface between two adjacent outflow struts and the outflow end of the window strut portion defining the synaptic window.

[0347] Example 61. The artificial heart valve of Example 59, as in any example herein, wherein each fusion window is defined by an axially extending window strut portion forming an upper portion above the fusion window and a lower portion below the fusion window, wherein the length of the upper and lower portions in the axial direction relative to the central longitudinal axis of the frame is greater than the width of the two angled strut portions.

[0348] Example 62. As in any example herein, specifically any of Examples 44 to 61, the artificial heart valve further includes a buffer element covering at least the outer surface of the tip region.

[0349] Example 63. An artificial heart valve comprising: a radially expandable and compressible annular frame, comprising: a plurality of interconnected struts defining a plurality of rows of units disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts including a plurality of outflow struts defining an outflow end and a plurality of inflow struts defining an inflow end, wherein each outflow strut includes two angled strut portions interconnected by a apical region, and wherein each inflow strut includes two angled strut portions interconnected by a apical region; and wherein each apical region bends between a corresponding pair of two angled strut portions, wherein each apical region has a narrowed width relative to the width of the two angled strut portions, and wherein each apical region forms an angle greater than 120 degrees between the two angled strut portions.

[0350] Example 64. As in any example herein, specifically Example 63, the artificial heart valve, wherein the angle is greater than 120 degrees and at most 140 degrees.

[0351] Example 65. The artificial heart valve of example 63 or 64, as in any example herein, wherein the angle is in the range of 135 to 140 degrees.

[0352] Example 66. An artificial heart valve, as in any example herein, particularly any of Examples 63 to 65, wherein each apical region includes a curved axially outward surface that is continuous with the axially outward surface of the two angled strut portions and an axially inward recess that is recessed from the axially inward surface of the two angled strut portions toward the curved outer surface.

[0353] Example 67. As in any example herein, specifically Example 66, the artificial heart valve has a curved outer surface of the apical region having a radius of curvature greater than 1 mm.

[0354] Example 68. As in any example herein, specifically Example 67, the artificial heart valve, wherein the curved outer surface of the apical region forms a single continuous surface defined by the radius of curvature between the outer surfaces of the two angled strut portions.

[0355] Example 69. An artificial heart valve, as in any example herein, specifically any of Examples 63 to 68, wherein each outflow strut forms an outflow edge of a unit in a first row of units disposed at the outflow end of the frame, wherein each inflow strut forms an inflow edge of a unit in a second row of units disposed at the inflow end of the frame, and wherein the unit in the first row of units has a longer axial length relative to the central longitudinal axis of the frame than the unit in the second row of units.

[0356] Example 70. The artificial heart valve of Example 69, as in any example herein, wherein the plurality of interconnecting struts further comprises a plurality of axial struts extending in the direction of a central longitudinal axis and spaced apart from each other around the circumference of the frame, wherein each axial strut forms the axial side of two adjacent units in the first column of units, and wherein each axial strut has a width greater than the width of the angled struts of the plurality of interconnecting struts.

[0357] Example 71. As in any example herein, specifically Example 70, an artificial heart valve, wherein the width of the axial strut is the width of the middle portion of the axial strut and wherein each axial strut includes a lower end portion and an upper end portion disposed on opposite sides of the middle portion, the lower end portion including a pore.

[0358] Example 72. As in any example herein, specifically the artificial heart valve of Example 71, further includes an outer edge disposed on the outer surface of the frame, surrounding the circumference of the frame and fastened to a portion of one of the plurality of interconnected struts, wherein the outflow end of the outer edge is fastened to a hole in each axial strut.

[0359] Example 73. As in any example herein, specifically Example 72, an artificial heart valve wherein the lateral edge extends from the inflow end of the frame toward the outflow end and close to the lower end portion of each axial strut.

[0360] Example 74. An artificial heart valve, as in any example herein, specifically any of Examples 63 to 73, wherein the length of each apical region is at least 25% of the total length of the outflow or inflow struts formed by the apical region and the two angled strut portions.

[0361] Example 75. As in any example herein, specifically Example 74, an artificial heart valve in which the length of each apical region is in the range of 0.9 mm to 2.2 mm.

[0362] Example 76. As in any example herein, specifically Example 74, an artificial heart valve in which the length of each apical region is in the range of 1.9 mm to 2.2 mm.

[0363] Example 77. The artificial heart valve of Example 74, as in any example herein, wherein the length of each apical region at the outflow end is in the range of 1.8 mm to 2.4 mm and wherein the length of each apical region at the inflow end is in the range of 0.8 mm to 1.2 mm.

[0364] Example 78. An artificial heart valve, as in any of the examples in this document, specifically any of Examples 63 to 77, wherein the narrowed width of each apical region is 0.06 mm to 0.15 mm smaller than the width of the two angled strut portions.

[0365] Example 79. An artificial heart valve, as in any example herein, specifically any of Examples 63 to 78, wherein the width of the angled strut portion is 0.3 mm and the narrowed width of each apical region is in the range of 0.15 mm to 0.24 mm.

[0366] Example 80. An artificial heart valve, as in any example herein, specifically any of Examples 63 to 79, wherein one or more of the apical regions are twisted about a transverse axis of the apical region such that the apical region comprises an assembled, undamaged twisted outer surface.

[0367] Example 81. As in any example herein, specifically any of Examples 63 to 80, the artificial heart valve further comprises a plurality of leaflets fastened to a frame and further comprises a plurality of connecting windows formed by struts of a plurality of interconnecting struts forming a unit of a first row of units disposed at an outflow end of the frame, wherein each connecting window is configured to receive a connecting flap of two adjacent leaflets of the plurality of leaflets.

[0368] Example 82. As in any example herein, specifically Example 81, an artificial heart valve, wherein each synaptic window is spaced apart by an upper axial strut extending between an interface between two adjacent outflow struts and an axially extending window strut portion defining the synaptic window and the outflow end of the frame.

[0369] Example 83. As in any example herein, specifically Example 81, of the artificial heart valve, wherein each fusion window is defined by an axially extending window strut portion forming an upper portion above the fusion window and a lower portion below the fusion window, and wherein the length of the upper and lower portions in the axial direction relative to the central longitudinal axis of the frame is greater than the width of the two angled strut portions.

[0370] Example 84. An artificial heart valve comprising: a radially expandable and compressible annular frame including: a plurality of interconnected struts defining a plurality of rows of units disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts including a plurality of outflow struts defining an outflow end and a plurality of inflow struts defining an inflow end, wherein each outflow strut includes two angled strut portions interconnected by a apex region, and wherein each inflow strut includes two angled strut portions interconnected by a apex region; and wherein each apex region bends between a corresponding pair of two angled strut portions, wherein each apex region has a narrowed width relative to the width of the two angled strut portions, and wherein each apex region is configured to plastically deform during initial radial compression of the frame such that it becomes strain-hardened and the bending point of the frame shifts away from the apex region to the end of the angled strut portion during subsequent radial expansion.

[0371] Example 85. An artificial heart valve comprising: a radially expandable and compressible annular frame including: a plurality of interconnected struts defining a plurality of rows of units disposed between an inflow end and an outflow end of the frame, the plurality of rows of units including a first row of units disposed at the outflow end, the units in the first row of units having a greater axial length than the units in the remaining rows of units in the plurality of rows of units; and a plurality of axial struts, each axial strut defining an axial side of two adjacent units in the first row of units and including: a middle portion having a width greater than the width of the angled struts of the plurality of interconnected struts; and an upper end portion and a lower end portion disposed on opposite ends of the middle portion and each wider than the width of the middle portion.

[0372] Example 86. As in any example herein, specifically Example 85, an artificial heart valve, wherein the lower portion includes a pore.

[0373] Example 87. As in any example herein, specifically the artificial heart valve of Example 86, further includes an outer edge disposed on the outer surface of the frame, surrounding the circumference of the frame and fastened to a portion of one of the plurality of interconnected struts, wherein the outflow end of the outer edge is fastened to a hole in each axial strut.

[0374] Example 88. An artificial heart valve, as in any example herein, specifically any of Examples 85 to 87, wherein each of the plurality of columns comprises nine units and wherein the plurality of columns comprises three columns.

[0375] Example 89. As in any example herein, specifically any one of Examples 85 to 88, the artificial heart valve further comprises a plurality of connected windows defined by window strut portions extending axially from the frame, wherein each connected window is defined by a set of window strut portions forming the axial sides of two adjacent units in the first column of units.

[0376] Example 90. As in any example herein, specifically Example 89, the artificial heart valve further comprises a plurality of leaflets fastened to a frame, wherein each leaflet comprises opposing commissural flaps disposed on opposite sides of the leaflet and a valve tip edge portion extending between the opposing commissural flaps, and wherein each commissural window is configured to receive commissural flaps from two adjacent leaflets of the plurality of leaflets.

[0377] Example 91. The artificial heart valve, as in any example herein, specifically Example 89 or 90, wherein the assembly of the window strut portions of each commissural window and each axial strut extends between two corresponding angled struts in a first row of angled struts and two angled struts in a second row of angled struts located at the outflow end of the frame, and wherein two adjacent axial struts are arranged around the circumference of the frame between the two sets of window strut portions.

[0378] Example 92. As in any example herein, specifically the artificial heart valve of Example 91, wherein the collection of window strut portions of each connecting window forms an upper portion above the connecting window and a lower portion below the connecting window, and wherein the length of the upper and lower portions of the collection of window strut portions in the axial direction relative to the central longitudinal axis of the frame is greater than the width of two angled struts in the first column of angled struts and two angled struts in the second column of angled struts.

[0379] Example 93. An artificial heart valve, as in any example herein, specifically any of Examples 85 to 92, wherein the plurality of interconnecting struts comprise a plurality of outflow struts defining the outflow end of a frame and a plurality of inflow struts defining the inflow end of a frame, and wherein each outflow strut and each inflow strut comprises two angled strut portions and a top region disposed between the two angled strut portions, the top region comprising a curved axially outward surface forming a single curved surface between the axially outward surfaces of the two angled strut portions and an axially inwardly recessed curved outer surface of the top region from the axially inwardly recessed surface of the two angled strut portions toward the top region, such that the width of the top region is less than the width of the two angled strut portions.

[0380] Example 94. As in any example herein, specifically Example 93, an artificial heart valve wherein the curved outer surface of the apical region has a radius of curvature in the range of 1 mm to 20 mm.

[0381] Example 95. The artificial heart valve of example 93 or 94, as in any example herein, wherein the indentation faces the unit in the plurality of rows of units and the curved outer surface is positioned opposite the indentation across the width of the apex region.

[0382] Example 96. The artificial heart valve of any of Examples 93 to 95, as in any example herein, wherein the length of the apical region is at least 25% of the length of the outflow or inflow struts of the apical region.

[0383] Example 97. An artificial heart valve, as in any example herein, specifically any of Examples 93 to 96, wherein the apical region forms an angle greater than 120 degrees and at most 140 degrees between two angled strut portions.

[0384] Example 98. As in any example herein, specifically any of Examples 93 to 97, the height of the apical region is defined as the width of the apical region, which is the height defined in the axial direction from the axially facing outward surface of the two angled strut portions to the axially facing outward surface of the apical region at the apex of the apical region.

[0385] Example 99. An artificial heart valve comprising: a radially expandable and compressible annular frame including a plurality of interconnected struts defining a plurality of rows of units disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts including a plurality of outflow struts defining an outflow end and a plurality of inflow struts defining an inflow end, wherein each of the plurality of outflow struts and the plurality of inflow struts includes: two angled strut portions; and a tip disposed between the two angled strut portions, the tip having an axially facing inner surface including two recesses recessed into an inner surface and a central protrusion disposed between the two recesses and away from the two recesses, wherein the two recesses form a thinned region of the tip with a width less than the width of the two angled strut portions.

[0386] Example 100. As in any example herein, specifically Example 99, an artificial heart valve in which two indentations form thinned regions at the tips on either side of a protrusion, the thinned regions having a width less than the width of the two angled strut portions.

[0387] Example 101. As in any example herein, specifically the artificial heart valve of Example 100, wherein at the central protrusion, the apex has a width greater than the width of the thinned region of the apex but less than the width of the two angled strut portions.

[0388] Example 102. An artificial heart valve, as in any of the examples herein, specifically any of Examples 99 to 101, wherein the height of the bump is in the range of 10 µm to 50 µm.

[0389] Example 103. An artificial heart valve, as in any example herein, specifically any of Examples 99 to 102, wherein the apex is comprised of a curved axially outward-facing surface between two angled strut portions and wherein two indentations extend from the axially inward-facing surfaces of the two angled strut portions toward the outer surface of the apex.

[0390] Example 104. An artificial heart valve, as in any example herein, specifically any of Examples 99 to 103, wherein each apex forms an angle greater than 120 degrees and at most 140 degrees between two angled strut portions.

[0391] Example 105. An artificial heart valve, as in any of the examples herein, specifically any of Examples 99 to 104, wherein the thinned region at the apex has a width that is 0.06 mm to 0.15 mm smaller than the width of the two angled strut portions.

[0392] Example 106. As in any example herein, specifically any of Examples 99 to 105, the artificial heart valve further comprises a plurality of leaflets fastened to a frame.

[0393] Example 107. As in any example herein, specifically the artificial heart valve of Example 106, further comprises a plurality of fused windows formed by the struts of the plurality of interconnecting struts of the units forming the first column of the plurality of units, the first column of units being disposed at the outflow end of the frame, and wherein each fused window is configured to receive a fused flap of two adjacent leaflets of the plurality of leaflets.

[0394] Example 108. As in any example herein, specifically Example 107, an artificial heart valve wherein each fusion window is spaced apart by an upper axial strut extending between an interface between two adjacent outflow struts and an axially extending window strut portion defining the fusion window and the outflow end of the frame.

[0395] Example 109. As in any example herein, specifically Example 107, an artificial heart valve, wherein each fusion window is defined by an axially extending window strut portion forming an upper portion above the fusion window and a lower portion below the fusion window, wherein the length of the upper and lower portions in the axial direction relative to the central longitudinal axis of the frame is greater than the width of the two angled strut portions.

[0396] Example 110. An artificial heart valve, as in any example herein, specifically any of Examples 99 to 109, wherein each outflow strut forms an outflow edge of a unit of a first row of units in the plurality of units at an outflow end and wherein each inflow strut forms an inflow edge of a unit of a second row of units in the plurality of units at an inflow end.

[0397] Example 111. As in any example herein, specifically the artificial heart valve of Example 110, wherein the unit in the first column has a longer axial length relative to the central longitudinal axis of the frame than the unit in the second column.

[0398] Example 112. The artificial heart valve of Example 111, as in any example herein, wherein the plurality of interconnecting struts further comprises a plurality of axial struts extending in the direction of a central longitudinal axis and spaced apart from each other around the circumference of the frame, wherein each axial strut forms the axial side of two adjacent units in the first column of units, and wherein each axial strut has a width greater than the width of the angled struts of the plurality of interconnecting struts.

[0399] Example 113. The artificial heart valve of Example 112, as in any example herein, wherein for each axial strut, the width of the axial strut is the width of the middle portion of the axial strut and wherein the axial strut further includes an upper portion and a lower portion disposed on opposite ends of the middle portion, each of the upper portion and the lower portion being wider than the width of the middle portion.

[0400] Example 114. An artificial heart valve comprising: a radially expandable and compressible annular frame, comprising: a plurality of interconnected struts defining a plurality of rows of units disposed between a first end and a second end of the frame, the plurality of interconnected struts including a plurality of first struts defining the first end and a plurality of second struts defining the second end, wherein each first strut includes two angled strut portions interconnected by apexes; and wherein each of one or more apexes at the first end bends between a corresponding pair of two angled strut portions, has a narrowed width relative to the width of the two angled strut portions, and includes a central protrusion axially projecting inwardly away from the apex.

[0401] Example 115. The artificial heart valve of Example 114, as in any example herein, wherein the axially facing inner surface of each of one or more apexes includes two recesses, the protrusion separating the two recesses from each other, wherein each of the two recesses is recessed inward from the axially facing inner surface of the corresponding one of the protrusion and the two angled strut portions.

[0402] Example 116. The artificial heart valve of Example 115, as in any example herein, wherein for each of one or more apexes, the width of the apex at each of the two indentations is less than the width of the two angled strut portions and wherein the width of the apex at the protrusion is less than the width of the two angled strut portions and greater than the width of the apex at each of the two indentations.

[0403] Example 117. An artificial heart valve, as in any example herein, specifically any of Examples 114 to 116, wherein for each of one or more apexes, the height of the bump in the axial direction is in the range of 10 µm to 50 µm.

[0404] Example 118. An artificial heart valve, as in any example herein, specifically any of Examples 114 to 117, wherein for each of one or more apexes, the tip of the apex and the tip of the bump are aligned along the central longitudinal axis of the apex.

[0405] Example 119. An artificial heart valve, as in any example herein, specifically any of Examples 114 to 118, wherein each of one or more apexes comprises a curved axially outward-facing surface between two angled strut portions.

[0406] Example 120. An artificial heart valve, as in any example herein, specifically any of Examples 114 to 119, wherein each of one or more apexes forms an angle greater than 120 degrees and at most 140 degrees between two angled strut portions.

[0407] Example 121. As in any example herein, specifically any one of Examples 114 to 120, the artificial heart valve further comprises a plurality of leaflets fastened to a frame and a plurality of connecting windows formed by struts of a plurality of interconnecting struts forming a unit in a first row of units, the first row of units being disposed at a first end of the frame, the first end being an outflow end of the frame, and wherein each connecting window is configured to receive a connecting flap of two adjacent leaflets among the plurality of leaflets.

[0408] Example 122. As in any example herein, specifically Example 121, an artificial heart valve wherein each synaptic window is spaced apart by an upper axial strut extending between an interface between two adjacent outflow struts and an axially extending window strut portion defining the synaptic window and the outflow end of the frame.

[0409] Example 123. An artificial heart valve, as in any example herein, specifically any of Examples 114 to 122, wherein a first end is an outflow end and a second end is an inflow end, wherein each first strut forms an outflow edge of a unit of a first row of units in the plurality of units at the outflow end, wherein each second strut forms an inflow edge of a unit of a second row of units in the plurality of units at the inflow end, and wherein a unit in the first row of units has a longer axial length relative to the central longitudinal axis of the frame than a unit in the second row of units.

[0410] Example 124. The artificial heart valve of example 123, as in any example herein, wherein the plurality of interconnecting struts further comprises a plurality of axial struts extending in the direction of a central longitudinal axis and spaced apart from each other around the circumference of the frame, wherein each axial strut forms the axial side of two adjacent units in the first column of units, and wherein each axial strut has a width greater than the width of the angled struts of the plurality of interconnecting struts.

[0411] Example 125. The artificial heart valve of Example 124, as in any example herein, wherein for each axial strut, the width of the axial strut is the width of the middle portion of the axial strut and wherein the axial strut further includes an upper portion and a lower portion disposed on opposite ends of the middle portion, each of the upper portion and the lower portion being wider than the width of the middle portion.

[0412] Example 126. An artificial heart valve of any of Examples 114 to 125, as in any example herein, wherein each second strut comprises two angled strut portions interconnected by apexes, and wherein each of one or more apexes at the second end bends between corresponding pairs of angled strut portions, has a narrowed width relative to the width of the two angled strut portions, and comprises a central protrusion axially projecting inward from the apexes.

[0413] Example 127. An artificial heart valve, as in any example herein, specifically any of Examples 114 to 126, wherein one or more apexes at the first end include each apex at the first end.

[0414] Example 128. An artificial heart valve comprising: a radially expandable and compressible annular frame including: a plurality of interconnected struts defining a plurality of rows of units disposed between an inlet end and an outlet end of the frame, the plurality of rows of units including a first row of units disposed at the outlet end; and a plurality of axial struts, each axial strut defining an axial side of two adjacent units in the first row of units and having a width greater than the width of the angled struts of the plurality of interconnected struts, each axial strut including one or more slits disposed along the length of the axial strut, the one or more slits extending through a portion of the width of the axial strut.

[0415] Example 129. The artificial heart valve of Example 128, as in any example herein, wherein each of one or more slits extends from one of two lateral edges of a defining axial strut toward the other of two lateral edges, the two lateral edges being positioned opposite each other across the axial strut.

[0416] Example 130. The artificial heart valve of Example 129, as in any example herein, wherein the width of the axial strut is in the range of 0.5 to 1.0 mm and each of one or more slits has a closed end spaced 0.1 to 0.3 mm from one of the two lateral edges.

[0417] Example 131. The artificial heart valve of example 129 or 130, as in any example herein, wherein one or more slits include a plurality of slits spaced apart from each other along the length of an axial strut, wherein a first portion of the slits of the plurality of slits extends from a first lateral edge of two lateral edges toward a second lateral edge of two lateral edges, and wherein a second portion of the slits of the plurality of slits extends from the second lateral edge toward the first lateral edge.

[0418] Example 132. An artificial heart valve, as in any example herein, specifically any of Examples 128 to 131, wherein each slit has an axial height in the range of 0.075 to 0.3 mm.

[0419] Example 133. As in any example herein, specifically any of Examples 128 to 132, an artificial heart valve in which one or more slits are assembled to improve the compliance of the axial strut.

[0420] Example 134. An artificial heart valve, as in any example herein, specifically any of Examples 128 to 133, wherein one or more slits include a plurality of slits spaced apart from each other along the length of an axial strut, and wherein the plurality of slits are configured as a plurality of groups of slits, each group being spaced apart from an adjacent group by an amount greater than the spacing between the plurality of slits in the same group.

[0421] Example 135. The artificial heart valve of example 134, as in any example herein, wherein each group of a plurality of slits comprises two slits, each of the two slits extending from one of the different lateral edges of the two lateral edges defining the axial strut through a portion of the width of the axial strut, the width being defined between the two lateral edges.

[0422] Example 136. The artificial heart valve of example 134 or 135, as in any example herein, wherein the plurality of groups of slits includes three groups of two slits.

[0423] Example 137. As in any example herein, specifically any of Examples 128 to 136, an artificial heart valve wherein the unit in the first column has a larger axial length than the unit in the remaining columns of the plurality of columns.

[0424] Example 138. An artificial heart valve comprising: a radially expandable and compressible annular frame including: a plurality of interconnected struts defining a plurality of rows of units disposed between an inlet end and an outlet end of the frame, the plurality of rows of units including a first row of units disposed at the outlet end; and a plurality of axial struts, each axial strut defining an axial side of two adjacent units in the first row of units and having a width greater than the width of the angled struts of the plurality of interconnected struts, each axial strut including a plurality of slits spaced apart from each other along the length of the axial strut, each of the plurality of slits extending through a portion of the width of the axial strut.

[0425] Example 139. An artificial heart valve comprising: a radially expandable and compressible frame, comprising: a plurality of interconnected struts defining a plurality of rows of units disposed between a first end and a second end of the frame, the plurality of interconnected struts including a plurality of first struts defining the first end and a plurality of second struts defining the second end, wherein each first strut includes: two angled strut portions; and a top region disposed between the two angled strut portions, the top region being curved between the two angled strut portions and having a narrowed width relative to the width of the two angled strut portions; and a covering element surrounding and covering the top region of the frame.

[0426] Example 140. As in any example herein, specifically Example 139, an artificial heart valve wherein the covering element comprises multiple continuous loops of material strips or bands.

[0427] Example 141. As in any example herein, specifically Example 140, an artificial heart valve, wherein the top region of the frame includes a top and two thinned strut portions extending outward from the top in opposite directions, wherein the width of the two thinned strut portions is narrower than the width of the two angled strut portions, wherein the top region includes a shoulder on either side of the top region transitioning from the narrower two thinned strut portions of the top region to the wider two angled strut portions, and wherein such multiple continuous loops of material strips or bands surround the two thinned strut portions between the shoulders of the top region.

[0428] Example 142. The artificial heart valve of any example herein, specifically Example 140 or 141, wherein the material of the covering element comprises PTFE, UHMWPE or PEEK.

[0429] Example 143. An artificial heart valve, as in any example herein, specifically any of Examples 140 to 142, wherein the covering element comprises a plurality of bridging portions, each bridging portion extending between the plurality of loops in a proximal apex region, the plurality of bridging portions extending along a first end of the frame.

[0430] Example 144. As in any example herein, specifically Example 139, an artificial heart valve, wherein the covering element includes a valve disposed on a lateral edge surrounding a first surface of the frame.

[0431] Example 145. As in any instance herein, specifically Example 144 of the artificial heart valve, wherein the first surface is the inner surface of the frame.

[0432] Example 146. As in any instance herein, specifically the artificial heart valve of example request 144, wherein the first surface is the outer surface of the frame.

[0433] Example 147. An artificial heart valve, as in any example herein, specifically any of Examples 144 to 146, wherein the valve extends from a first edge of a lateral edge attached to a first end of a frame and wherein the valve covers the top region from a first surface of the frame to an opposite second surface.

[0434] Example 148. An artificial heart valve, as in any example herein, specifically any of Examples 144 to 147, wherein the lateral margin includes a plurality of valves spaced apart from each other around a first edge of the lateral margin and wherein the first edge and the plurality of valves are secured to a first end of a frame by a plurality of sutures extending through the lateral margin and around the plurality of first struts.

[0435] Example 149. An artificial heart valve, as in any example herein, specifically any of Examples 139 to 148, wherein the first end is the inlet end of the frame.

[0436] Example 150. The artificial heart valve of any of Examples 139 to 149, as in any example herein, wherein each apical region forms an angle greater than 120 degrees and at most 140 degrees between the two angled strut portions of the corresponding first strut.

[0437] Example 151. An artificial heart valve comprising: a radially expandable and compressible annular frame including a plurality of interconnected struts defining a plurality of rows of units disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts including a plurality of outflow struts defining an outflow end and a plurality of inflow struts defining an inflow end, wherein each of the plurality of inflow struts includes: two angled strut portions; and a top region disposed between the two angled strut portions, the top region including a curved axially outward surface forming a single curved surface between the axially outward surfaces of the two angled strut portions and an axially inwardly recessed surface concave from the axially inwardly facing surfaces of the two angled strut portions toward the curved outer surface of the top region, such that the width of the top region is less than the width of the two angled strut portions and a shoulder is formed at either end of the top region where the smaller width of the top region transitions to the width of the two angled strut portions; and a covering element including a plurality of loops surrounding and covering at least a portion of the top region of the frame between the shoulders of the top region.

[0438] Example 152. As in any example herein, specifically Example 151, an artificial heart valve, wherein the covering element further includes a plurality of bridging portions, each bridging portion extending between the plurality of loops in a proximal apex region, the plurality of bridging portions extending around the inflow end of the frame.

[0439] Example 153. The artificial heart valve, as in any example herein, specifically Example 151 or 152, wherein the covering element comprises a strip of material having a dynamic coefficient of friction of less than 0.1 relative to the inner wall of the delivery sheath, through which the artificial heart valve advances as it navigates toward the implantation site.

[0440] Example 154. An artificial heart valve, as in any example herein, specifically any of Examples 151 to 153, wherein the covering element covers the top region of each inflow strut but does not cover the two angled strut portions of each inflow strut.

[0441] Example 155. An artificial heart valve comprising: a radially expandable and compressible annular frame including a plurality of interconnected struts defining a plurality of rows of units disposed between a first end and a second end of the frame, the plurality of interconnected struts including a plurality of first struts defining the first end and a plurality of second struts defining the second end, wherein each of the plurality of first struts includes a apex region; and a side edge disposed around an inner or outer surface of the frame and coupled to the frame, the side edge including: a first edge extending circumferentially around the side edge and connected to the first end of the frame; and a plurality of axially extending valves extending from the first edge and spaced apart from each other, each of the plurality of axially extending valves covering a corresponding apex region such that the apex region is covered.

[0442] Example 156. The artificial heart valve of Example 155, as in any example herein, wherein the lateral edge is disposed around the inner surface of the frame and each valve surrounds the corresponding top region from the inner surface of the frame to the outer surface and is secured to the top region.

[0443] Example 157. The artificial heart valve of Example 155, as in any example herein, wherein the lateral edge is disposed around the outer surface of the frame and each valve surrounds the corresponding apical region from the outer surface of the frame to the inner surface and is secured to the apical region.

[0444] Example 158. An artificial heart valve, as in any example herein, specifically any of Examples 155 to 157, wherein each of the plurality of first struts comprises: two angled strut portions; and a apex region disposed between the two angled strut portions, the apex region comprising an apex and two thinned strut portions extending outward from the apex in opposite directions relative to the central longitudinal axis of the apex region, wherein the width of the two thinned strut portions is less than the width of the two angled strut portions.

[0445] Example 159. As in any example herein, specifically Example 158, an artificial heart valve in which each valve covers the corresponding apical region but does not cover the two angled strut portions as a whole.

[0446] Example 160. The artificial heart valve of example 158 or 159, as in any example herein, wherein the combined length of the two thinned strut portions is at least 25% of the length of the corresponding first strut including the tip region.

[0447] Example 161. An artificial heart valve, as in any example herein, specifically any of Examples 155 to 160, wherein the first end of the frame is the inlet end.

[0448] Example 162. An artificial heart valve comprising: a radially expandable and compressible frame, including: a plurality of interconnected struts defining a plurality of rows of units disposed between a first end and a second end of the frame, the plurality of interconnected struts including a plurality of first struts defining the first end and a plurality of second struts defining the second end, wherein each first strut includes: two angled strut portions; and a top region disposed between the two angled strut portions, the top region being curved between the two angled strut portions and having a narrowed width relative to the width of the two angled strut portions; an outer edge disposed around an outer surface of the frame; and a covering element including a plurality of loops extending around the top region of the frame and extending through the outer edge, such that the outer edge is secured to the frame.

[0449] Example 163. As in any example herein, specifically the artificial heart valve of Example 162, wherein the plurality of circuits surround and cover the apical region.

[0450] Example 164. The artificial heart valve of example 162 or 163, as in any example herein, wherein the apical region comprises a curved axially outward surface forming a single surface between the axially outward surfaces of the two angled strut portions and an axially inwardly concave outer surface of the curved outer surface of the apical region from the axially inwardly oriented surfaces of the two angled strut portions toward the apical region, such that a shoulder is formed at either end of the apical region where the narrowed width of the apical region transitions to the width of the two angled strut portions.

[0451] Example 165. As in any example herein, specifically Example 164, an artificial heart valve in which the plurality of circuits cover the top region between the shoulders of the top region.

[0452] Example 166. An artificial heart valve, as in any example herein, specifically any of Examples 162 to 165, wherein the covering element further comprises a plurality of sutures extending through the edge portion of the outer margin between adjacent top regions at the first end of the frame.

[0453] Example 167. An artificial heart valve, as in any example herein, specifically any of Examples 162 to 166, wherein the first end of the frame is the inlet end of the frame.

[0454] Example 168. An artificial heart valve, as in any example herein, specifically any of Examples 162 to 167, wherein the covering element is a suture.

[0455] Example 169. An artificial heart valve, as in any example herein, specifically any of Examples 162 to 168, wherein the material of the covering element comprises PTFE, UHMWPE or PEEK.

[0456] Example 170. An artificial heart valve comprising: a radially expandable and compressible annular frame including: a plurality of interconnected struts defining a plurality of rows of units disposed between an inflow end and an outflow end of the frame, the plurality of rows of units including a first row of units disposed at the outflow end; and a plurality of connecting windows, wherein each connecting window is formed by an assembly of window strut portions extending axially between a first row of interconnected struts and a second row of interconnected struts forming the first row of units, and wherein the outflow end portion of the assembly of window strut portions disposed above the connecting window includes two apertures disposed therein.

[0457] Example 171. As in any example herein, specifically Example 170, an artificial heart valve, wherein the set of window strut portions defines the axial sides of two adjacent units in the first column of units.

[0458] Example 172. The artificial heart valve of example 170 or 171, as in any example herein, wherein the first column of interconnected struts forms the outflow end of the frame.

[0459] Example 173. As in any example herein, specifically any of Examples 170 to 172, the artificial heart valve further comprises a plurality of leaflets disposed within a frame, wherein each commissural window is configured to accommodate a commissural flap of two adjacent leaflets among the plurality of leaflets.

[0460] Example 174. As in any example herein, specifically Example 173, an artificial heart valve in which two openings are configured to receive one or more fasteners for securing a commissural flap within the commissural window.

[0461] Example 175. An artificial heart valve, as in any example herein, specifically any of Examples 170 to 174, wherein the two pores are axially spaced apart from each other.

[0462] Example 176. An artificial heart valve, as in any example herein, specifically any of Examples 170 to 175, wherein two pores are aligned with each other in the axial direction.

[0463] Example 177. An artificial heart valve comprising: a radially expandable and compressible annular frame including a plurality of interconnected struts defining a plurality of rows of units disposed between an inlet end and an outlet end of the frame, the plurality of interconnected struts including: a plurality of rows of angled struts including a first row of angled struts and a second row of angled struts defining the outlet end; and a plurality of axially extending struts extending between the first row of angled struts and the second row of angled struts, each axially extending strut defining a connecting window therein and including a first end portion disposed on a first side of the connecting window and connected to the first row of angled struts, wherein the first end portion includes a concave region, wherein the first end portion is directly connected to a convex surface in the bottom of the angled strut of the first row of angled struts.

[0464] Example 178. The artificial heart valve of Example 177, as in any example herein, wherein the first end portion includes two concave regions, one concave region being adjacent to a convex surface curved at the bottom of each of the angled struts of the first row of angled struts on each side of the first end portion.

[0465] Example 179. The artificial heart valve of example 177 or 178, as in any example herein, wherein each axially extending strut has a width greater than the width of the angled strut of the first row of angled struts, and wherein a concave region forms a narrowing region in the first end portion of the axial strut.

[0466] Example 180. An artificial heart valve, as in any example herein, specifically any of Examples 177 to 179, wherein each axially extending strut includes a second end portion disposed on a second side of the connecting window and connected to the second row of angled struts, and wherein the second end portion includes a concave region therein adjacent to the angled struts to which the second end portion is connected.

[0467] Example 181. An artificial heart valve, as in any example herein, specifically any of Examples 177 to 180, wherein a convex surface at the base of an angled strut extends from a concave surface in the angled strut, such that a transition region with three changes in concavity is defined between the angled strut and the first end portion of the axially extending strut.

[0468] Example 182. An artificial heart valve, as in any example herein, specifically any of Examples 177 to 181, wherein the plurality of units include a first unit disposed at the outflow end, and wherein each axially extending strut defines the axial sides of two adjacent units in the first unit.

[0469] Example 183. An artificial heart valve, as in any example herein, specifically any of Examples 1 to 20, wherein the plurality of interconnecting struts include a plurality of horizontal struts that extend between adjacent units in the same column of the plurality of columns and space the adjacent units in the same column of the plurality of columns.

[0470] Example 184. The artificial heart valve, as in any example herein, specifically Example 183, wherein each horizontal strut connects two angled struts in the first row of angled struts and two angled struts in the adjacent second row of angled struts.

[0471] Example 185. An artificial heart valve, as in any example herein, specifically any of Examples 128 to 137, wherein the plurality of interconnecting struts include a plurality of horizontal struts extending between adjacent units of the same column and spacing adjacent units of the same column.

[0472] Example 186. The artificial heart valve, as in any example herein, specifically Example 185, wherein each horizontal strut connects two angled struts in the first row of angled struts and two angled struts in the adjacent second row of angled struts.

[0473] Unless otherwise stated, the morphological bodies described herein with respect to any instance may be combined with other morphological bodies described in any one or more of the other instances. For example, any one or more of these morphological bodies of a frame for an artificial heart valve may be combined with any one or more morphological bodies of another frame for an artificial heart valve.

[0474] Given the many possible instances in which the principles of the disclosed technology can be applied, it should be recognized that the illustrated examples are merely preferred examples of the disclosed technology and should not be considered as limiting the scope of the claimed subject matter. In fact, the scope of the claimed subject matter is defined by the following patent application scope and its equivalents. [Simplified Explanation of the Diagram]

[0025] Figure 1 is a perspective view of an artificial heart valve based on an example.

[0026] Figure 2 is a side view of an example of a delivery device assembled for delivering and implanting a radially expandable artificial heart valve at the implantation site.

[0027] Figure 3 is a perspective view of an artificial heart valve according to another example.

[0028] Figure 4 is a side view of the artificial heart valve of Figure 3, which is radially compressed onto and around a portion of the distal part of the delivery device.

[0029] Figure 5 is a side view of a frame for an artificial heart valve according to another example, the frame having a top or top region at the inlet or outlet of the frame that forms a relatively large angle between the angled struts of the frame and has a relatively large radius of curvature.

[0030] Figure 6 is an enlarged view of a portion of the frame of Figure 6 showing the angle between the angled pillars at the top region.

[0031] Figure 7 is an enlarged view of a portion of the frame of an artificial heart valve, which includes multiple connected windows offset from the outflow end of the frame and disposed at the outflow end of the frame toward the lower portion of two adjacent units in a row of units.

[0032] Figure 8A is an enlarged view of a portion of an exemplary frame of an artificial heart valve, which includes the window strut portion of the connecting window forming the frame and a single aperture above the connecting window.

[0033] Figure 8B is an enlarged view of a portion of an exemplary frame of an artificial heart valve, which includes the window support portion of the connecting window forming the frame and two openings above the connecting window.

[0034] Figure 9A is a side view of a portion of a frame including an outflow top region at the outflow end of the frame and an inflow top region at the inflow end of the frame, the outflow and inflow top regions having narrowed widths extending to different lengths.

[0035] Figure 9B is an enlarged view of one of the top outflow regions of the frame in Figure 9A.

[0036] Figure 9C is an enlarged view of one of the inflow top regions of the frame in Figure 9A.

[0037] Figure 10A is a side view of a portion of a frame including top regions at both the outflow and inflow ends of the frame, the top regions having a narrowed width extending a certain distance along the outflow or inflow support of the frame.

[0038] Figure 10B is an enlarged view of one of the top regions at the outlet end of the frame in Figure 10A.

[0039] Figure 10C is an enlarged view of one of the top regions at the inflow end of the frame in Figure 10A.

[0040] Figure 11 is a partial view of a frame for an artificial heart valve according to an example, the frame including axially extending window pillar portions that define the connecting window of the frame.

[0041] Figure 12 shows an overlapping view of the frame for an artificial heart valve in radial compression and radial expansion configurations.

[0042] Figure 13 is a perspective view of an example of an artificial heart valve including a frame and fastened to the outer edge of the frame.

[0043] Figures 14A and 14B show the top region of the frame of Figure 10A, wherein the top region is rotated or twisted about its axis to form a twisted outer surface.

[0044] Figure 15 is a partial view of the frame of Figure 10A, showing an exemplary buffer element coupled to and covering at least a portion of the top area of ​​the frame.

[0045] Figure 16A is a partial view of the frame used for an artificial heart valve, showing one top of the frame which includes two curved internal recesses separated from each other by a central protrusion.

[0046] Figure 16B is a detailed view of a single top of Figure 16A.

[0047] Figure 17 is a partial view of the frame for an artificial heart valve, showing a widened axial strut of the frame that includes multiple slits.

[0048] Figure 18 is a partial view of a second artificial heart valve expanded within a previously implanted first artificial heart valve and a balloon that bends the adjacent axial struts of the first and second artificial heart valves away from each other to create space for the coronary arteries to enter.

[0049] Figure 19 is a partial view of the frame of Figure 11, which includes axial struts having a plurality of slits assembled to improve the compliance of the axial struts.

[0050] Figure 20 is a side view of a portion of the frame of an artificial heart valve, including a top region and an exemplary covering element that surrounds and covers at least a portion of the top region.

[0051] Figure 21 is a side view of a portion of the frame of an artificial heart valve, including a top region at the first end of the frame that is covered and enveloped by an exemplary covering element.

[0052] Figure 22 is an end view of part of the frame in Figure 21.

[0053] Figure 23 is a perspective side view of a portion of the frame of an artificial heart valve, including a top region at the first end of the frame that is covered and enveloped by another exemplary covering element.

[0054] Figure 24 is an end view of part of the frame in Figure 23.

[0055] Figure 25 is a side view of a portion of an artificial heart valve, including a frame and a side edge disposed around the surface of the frame, the side edge including a distal flap assembled to surround and cover the top region at the first end of the frame.

[0056] Figure 26 is a cross-sectional view of the artificial heart valve in Figure 25.

[0057] Figure 27 is a perspective view of a portion of the frame of an artificial heart valve from within the frame, showing an exemplary covering element extending around the top region of the frame and extending through the outer edge disposed around the outer surface of the frame such that the covering element covers at least a portion of the top region and secures the outer edge to the frame.

[0058] Figure 28A shows a first part of an exemplary method for using the same covering element to cover the top region of a frame and fasten the outer edge to the frame, wherein the covering element is used to form a plurality of loops around the first top region and through the outer edge.

[0059] Figure 28B shows a second part of an exemplary method for using the same covering element to cover the top region of a frame and fasten the outer edge to the frame, wherein the covering element is used to form two nodes at the first top region after forming multiple loops around the first top region.

[0060] Figure 28C shows a third part of an exemplary method for covering the top region of a frame and securing the outer edge to the frame using the same covering element, wherein the covering element is used to form an overlap between adjacent top regions along the edge portion of the outer edge, and then to form a loop around a second top region.

[0061] Figure 29 is a perspective view of the artificial heart valve from the outside, showing the outer edge of the artificial heart valve attached to the inlet end of the frame and a covering element that extends around the top region of the frame and through the outer edge.

[0062] Figure 30 is a perspective side view of a portion of the frame of an artificial heart valve, including an axially extending strut defining a connecting window therein, wherein the end portion of the axially extending strut disposed on one side of the connecting window includes a concave region at the bottom of an angled strut of the frame connected to the axially extending strut.

[0063] Figure 31 is an enlarged view of a portion of the frame of an artificial heart valve, showing another example of a concave region in the transition area between the outflow end of the axially extending strut of the frame and the angled strut of the frame.

Claims

1. An artificial heart valve comprising: a radially expandable and compressible annular frame including: a plurality of interconnected struts defining a plurality of rows of units disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts including a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end, wherein each outflow strut includes two angled strut portions interconnected by a apical region, and wherein each inflow strut includes two angled strut portions interconnected by a apical region, wherein each apical region bends between a corresponding pair of two angled strut portions, wherein each apical region has a narrowed width and a length extending at least 25% of the total length of one of the outflow struts or the inflow struts, and wherein the narrowed width is less than the width of one of the two angled strut portions.

2. The artificial heart valve of claim 1, wherein each apical region forms an angle greater than 120 degrees and at most 140 degrees between two angled strut portions of a corresponding outflow strut or inflow strut.

3. The artificial heart valve of claim 1, wherein each apical region includes a curved outer surface having a radius of curvature greater than 1 mm, the curved outer surface extending between the outer surfaces of the two angled strut portions of a corresponding outflow strut or inflow strut.

4. The artificial heart valve of claim 1, wherein the length of each apical region is in the range of 0.9 mm to 2.2 mm.

5. The artificial heart valve of claim 1, wherein the length of each apical region is in the range of 1.9 mm to 2.2 mm.

6. The artificial heart valve of claim 1, wherein the length of each apical region at the outflow end is in the range of 1.8 mm to 2.4 mm and wherein the length of each apical region at the inflow end is in the range of 0.8 mm to 1.2 mm.

7. The artificial heart valve of claim 1, wherein the narrowed width of each apical region is 0.06 mm to 0.15 mm smaller than the width of the two angled strut portions.

8. The artificial heart valve of claim 1, further comprising a plurality of leaflets fastened to the frame and a plurality of fused windows formed by struts of a plurality of interconnecting struts of a unit forming a first column of the plurality of columns, the first column of the unit being disposed at the outflow end of the frame, wherein each fused window is configured to receive a fused flap of two adjacent leaflets of the plurality of leaflets.

9. The artificial heart valve of claim 8, wherein each fusion window is defined by an axially extending window strut portion forming an upper portion above the fusion window and a lower portion below the fusion window, and wherein the length of the upper portion and the lower portion in an axial direction relative to a central longitudinal axis of the frame is greater than the width of the two angled strut portions.

10. The artificial heart valve of claim 9, wherein the upper portion includes a concave region disposed therein, adjacent to a convex surface at the bottom of one of the bottom surfaces of one of the two angled strut portions connected to the upper portion, and wherein the convex surface extends from the concave surface of the first angled strut portion.

11. An artificial heart valve comprising: a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of units disposed between a first end and a second end of the frame, the plurality of interconnected struts including a plurality of first struts defining the first end and a plurality of second struts defining the second end, wherein each first strut includes two angled strut portions interconnected by a apical region, wherein the apical region is curved between the two angled strut portions and has a narrowed width relative to the width of one of the two angled strut portions, and wherein the apical region forms an angle greater than 120 degrees between the two angled strut portions.

12. The artificial heart valve as requested in item 11, wherein the angle is greater than 120 degrees and at most 140 degrees.

13. The artificial heart valve of claim 11, wherein the tip region includes a curved axially outward surface that is continuous with the axially outward surfaces of the two angled strut portions and an axially inward recess that recesses from the axially inward surfaces of the two angled strut portions toward the curved axially outward surface.

14. The artificial heart valve of claim 11, wherein each second strut comprises two angled strut portions interconnected by a tip region, the tip region being curved between the two angled strut portions and having a narrowed width relative to the width of one of the two angled strut portions, wherein the tip region forms an angle greater than 120 degrees between the two angled strut portions, and wherein the first end is an outflow end of the frame and the second end is an inflow end of the frame.

15. The artificial heart valve of claim 14, wherein each first strut forms an outflow edge of a unit in a first row of units disposed at the outflow end of the frame, wherein each second strut forms an inflow edge of a unit in a second row of units disposed at the inflow end of the frame, and wherein the unit in the first row of units has a longer axial length relative to a central longitudinal axis of the frame than the unit in the second row of units.

16. The artificial heart valve of claim 15, wherein the plurality of interconnecting struts further comprises a plurality of axial struts extending in one direction of the central longitudinal axis and spaced apart from each other around one circumference of the frame, wherein each axial strut forms an axial side of two adjacent units in the first column of units, and wherein each axial strut has a width greater than the width of one of the angled struts of the plurality of interconnecting struts.

17. The artificial heart valve of claim 11, further comprising a plurality of leaflets fastened to the frame and further comprising a plurality of fusion windows formed by struts of a plurality of interconnecting struts forming a unit of a first column of the plurality of columns disposed at the first end of the frame, wherein each fusion window is configured to receive a fusion flap of two adjacent leaflets of the plurality of leaflets.

18. The artificial heart valve of claim 17, wherein each fusion window is defined by an axially extending window strut portion forming an upper portion above the fusion window and a lower portion below the fusion window, and wherein the upper portion includes two apertures disposed therein.

19. An artificial heart valve comprising: a radially expandable and compressible frame including: a plurality of interconnected struts defining a plurality of rows of units disposed between a first end and a second end of the frame, the plurality of interconnected struts including a plurality of first struts defining the first end and a plurality of second struts defining the second end, wherein each first strut includes: two angled strut portions; and a tip region disposed between the two angled strut portions, the tip region being curved between the two angled strut portions and having a narrowed width relative to the width of one of the two angled strut portions; and a covering element surrounding and covering the tip region of the frame.

20. The artificial heart valve of claim 19, wherein the covering element comprises a strip or a plurality of continuous loops of material strips or strips.

21. The artificial heart valve of claim 20, wherein the top region of the frame includes a top and two thinned strut portions extending outward from the top in opposite directions, wherein one of the two thinned strut portions is narrower than the width of one of the two angled strut portions, wherein the top region includes a shoulder on either side of the top region where the narrower of the two thinned strut portions transitions to the wider of the two angled strut portions, and wherein the plurality of continuous loops of the material strip or band surround the two thinned strut portions between the shoulders of the top region.

22. The artificial heart valve of claim 19, wherein the first end is an inlet end of the frame, and wherein each apical region forms an angle greater than 120 degrees and at most 140 degrees between the two angled strut portions of a corresponding first strut.

23. The artificial heart valve of any of claims 19 to 22, further comprising an outer edge disposed around an outer surface of the frame, wherein the covering element extends through the outer edge such that the outer edge is secured to the frame.

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