Expandable prosthetic heart valve with flattened tips

Abstract

A heart valve prosthesis comprising a radially expandable and compressible annular frame is disclosed. The frame comprises a plurality of interconnected rows of cells disposed between an inflow end and an outflow end of the frame, the interconnected rows of cells comprising a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. The frame further comprises a plurality of tip regions formed at the inflow end and the outflow end, each tip region curved between two angled strut portions and forming one of the outflow struts or one of the inflow struts with the two angled strut portions.Each tip region has a reduced width and a length extending at least 25% of the total length of the outflow strut or the inflow strut, the reduced width being less than the width of the two angled strut sections.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application 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 63 / 279,096, filed November 13, 2021, all of which are incorporated herein by reference in their entirety. TECHNICAL FIELD

[0002] The present disclosure relates to expandable prosthetic heart valves comprising frames with tip regions having a narrower width and a reduced height. BACKGROUND

[0003] The human heart can suffer from various valvular heart diseases. These valvular heart diseases can lead to significant dysfunction of the heart and ultimately require repair of the natural heart valve or replacement of the natural valve with an artificial valve. There are a number of known repair devices (e.g. stents) and artificial heart valves, as well as a number of known methods for implanting these devices and valves in humans. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver medical prostheses to locations in the body that are not easily accessible by surgery or where non-surgical access is desirable. In a specific example, a prosthetic heart valve can be inserted into a compressed or...It can be crimped onto the distal end of a delivery device and advanced through the patient's vasculature (e.g., through a femoral artery and the aorta) until the prosthesis reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, e.g., by inflating a balloon to which the prosthetic valve is attached, by actuating a mechanical actuator that exerts an expansion force on the prosthetic valve, or by extending the prosthetic valve from a sheath of the delivery device, allowing the prosthetic valve itself to expand to its functional size.

[0004] Most expandable transcatheter heart valves comprise a radially expandable and compressible cylindrical metal frame and prosthetic valves mounted within the frame. The frame may include a plurality of circumferentially extending rows of angled struts defining rows of open cells of the frame. The frame may have a plurality of apexes at both the inflow and outflow ends spaced apart along the circumference of the frame, with each apexes forming a junction between two angled struts (or strut portions) at either the inflow or outflow end of the frame. In some cases, prosthetic heart valves have frames with angled struts that form sharp angles at the apexes, resulting in relatively high stress concentrations at the apexes.Other prosthetic heart valves may have frames with tips that have essentially vertical U-shaped sections connecting adjacent angled struts at each tip, thereby distributing stresses across the angled struts and away from the tips. However, such tip shapes can increase the overall height of the frame (in the axial direction).

[0005] Another problem with the frame tip configurations described above is the exposed anterior or distal (e.g., inflow or inflow) tips, which interact with the inflatable balloon and / or the delivery sheath through which the delivery device travels en route to the implantation site. In some cases, for example, upon reaching the implantation site, the prosthetic heart valve may be pushed toward and over the balloon into a deployment position, causing the tips to rub and / or chafe against the balloon. In some cases, this may result in balloon damage, which may result in insufficient inflation at the implantation site. In other examples, the more pointed or sharp-edged tips at the distal end (e.g.,at the inflow end) of the valve frame during delivery through the vasculature and through a delivery sheath that extends along a portion of the vasculature to the implantation site, may strike or penetrate the delivery sheath, thereby damaging the sheath and possibly the vasculature.

[0006] US 9 603 727 B2 discloses an expandable stent for implantation into a body lumen, such as an artery. The stent consists of a plurality of radially expandable cylindrical rings generally aligned along a common longitudinal axis of the stent and interconnected by one or more connecting links arranged to provide longitudinal flexibility of the stent. The pattern of the connecting links is optimized to reduce stress on the connecting links and increase the longitudinal flexibility and safety of the stent. The stent includes a distal end ring and a proximal end ring, the length of which is shorter than the length of the body rings.

[0007] US 2020 / 0 352 709 A1 discloses a heart valve prosthesis including a frame having an inflow end, an outflow end, and a central portion. The frame is radially expandable from a collapsed configuration to an expandable configuration. The inflow end includes a plurality of first strut elements having a first strut width and forming a first angle between adjacent first strut elements, and the central portion includes a plurality of second strut elements having a second strut width and forming a second angle between adjacent second strut elements. A plurality of valve leaflets are disposed within the frame.At least one of the first and second angles or the first strut width and the second strut width are different such that when the heart valve prosthesis is crimped onto a cylindrical balloon and expandable by means of the cylindrical balloon, a diameter of the outflow end is different from a diameter of the middle part.

[0008] Accordingly, there is a need for improved frame designs for heart valve prostheses. OVERVIEW

[0009] This text describes examples of prosthetic heart valves that include a radially expandable and compressible, annular frame with a plurality of interconnected struts. The prosthetic heart valve may further include a valve assembly attached to the frame. In some examples, the struts of the frame may form a plurality of rows of cells disposed between an inflow end and an outflow end of the frame. The outflow end may be defined by a plurality of outflow struts and the inflow end by a plurality of inflow struts. The frame may further include a plurality of tip regions that curve between two angled strut portions and, with the two angled strut portions, form one of the inflow struts or outflow struts.The tip regions may be configured to be more atraumatic and have a lower height in the axial direction. For example, in some cases, the tip regions may have a reduced width (compared to the angled strut portions) extending along a circumferential length. In other cases, the tip regions (which may alternatively be referred to as apices) may have a reduced width and a central cusp protruding outward from the tapered or narrowed portions of the tip region.

[0010] In a representative example, a prosthetic heart valve comprises a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end and an outflow end of the frame, wherein the plurality of interconnected struts comprises a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. Each outflow strut comprises two angled strut sections interconnected by a tip region, and each inflow strut comprises two angled strut sections interconnected by a tip region.Each tip region curves between a corresponding pair of two angled strut portions, each tip region having a reduced width and a length extending at least 25% of a total length of the outflow strut or the inflow strut, and wherein the reduced width is less than a width of the two angled strut portions.

[0011] In another representative example, a prosthetic heart valve comprises: a radially expandable and compressible annular frame comprising a plurality of interconnected struts defining a plurality of rows of cells disposed between an outflow end and an inflow end of the frame, wherein the plurality of interconnected struts comprises a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. Each of the plurality of outflow struts and the plurality of inflow struts comprises: two angled strut portions and a tip region disposed between the two angled strut portions.The tip portion includes a curved, axially facing outer surface forming a single curve between the axially facing outer surfaces of the two angled strut portions, and an axially facing inner recess recessed from the axially facing inner surfaces of the two angled strut portions inwardly toward the curved outer surface of the tip portion such that a width of the tip portion is smaller than a width of the two angled strut portions.

[0012] In another representative example, a prosthetic heart valve comprises: a radially expandable and compressible annular frame comprising a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end and an outflow end of the frame, wherein the plurality of interconnected struts comprises a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. Each of the plurality of outflow struts and the plurality of inflow struts comprises: two angled strut portions; and a tip region disposed between the two angled strut portions, the tip region comprising a tip and two tapered orcomprises tapered strut sections extending outwardly from the tip in opposite directions relative to a central longitudinal axis of the tip region. A width of the two tapered strut sections is less than a width of the two angled strut sections, and a combined length of the two tapered strut sections is at least 25% of a length of a corresponding outflow strut or inflow strut comprising the tip region.

[0013] In another representative example, a prosthetic heart valve comprises a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end and an outflow end of the frame, wherein the plurality of interconnected struts comprises a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. Each outflow strut comprises two angled strut sections interconnected by a tip region, and each inflow strut comprises two angled strut sections interconnected by a tip region.Each tip section curves between a corresponding pair of two angled strut sections, with each tip section having a tapered width relative to a width of the two angled strut sections. Each tip section forms an angle between the two angled strut sections that is greater than 120 degrees.

[0014] In another representative example, a prosthetic heart valve comprises a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end and an outflow end of the frame, wherein the plurality of interconnected struts comprises a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. Each outflow strut comprises two angled strut sections interconnected by a tip region, and each inflow strut comprises two angled strut sections interconnected by a tip region. Each tip region curves between a corresponding pair of two angled strut sections, and each tip region has a tapered orReduced width relative to the width of the two angled strut sections. Each tip region is configured to plastically deform upon initial radial compression of the frame, causing it to work harden and shifting the frame's bending points toward the ends of the angled strut sections, away from the tip region, during subsequent radial expansion.

[0015] In another representative example, a heart valve prosthesis comprises a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end and an outflow end of the frame, wherein the plurality of rows of cells includes a first row of cells disposed at the outflow end, wherein the cells of the first row of cells have a greater axial length than the cells of the remaining rows of cells of the plurality of rows of cells.The frame further comprises a plurality of axial struts, each axial strut defining an axial side of two adjacent cells of the first row of cells and comprising: a central portion having a width greater than a width of the angled struts of the plurality of interconnected struts; and an upper end portion and a lower end portion disposed at opposite ends of the central portion and each wider than the width of the central portion.

[0016] In another representative example, a heart valve prosthesis comprises a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end and an outflow end of the frame, wherein the plurality of interconnected struts comprises a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end.Each of the plurality of outflow struts and the plurality of inflow struts comprises two angled strut sections and a tip disposed between the two angled strut sections, the tip having an axially facing inner surface including two inner depressions depressed into the inner surface and a central protrusion projecting away from and disposed between the two inner depressions. The two inner depressions form tapered regions of the tip whose width is less than the width of the two angled strut sections.

[0017] In another representative example, a prosthetic heart valve comprises a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between a first end and a second end of the frame, the plurality of interconnected struts comprising a plurality of first struts defining the first end and a plurality of second struts defining the second end, each first strut comprising two angled strut portions connected by a tip.Each tip of one or more tips at the first end curves between a corresponding pair of two angled strut members, has a reduced width relative to a width of the two angled strut members, and includes a central protuberance projecting from an axially facing inner surface of the tip.

[0018] In another representative example, a prosthetic heart valve comprises a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end and an outflow end of the frame, wherein the plurality of rows of cells comprises a first row of cells disposed at the outflow end and a plurality of axial struts. Each axial strut defines an axial side of two adjacent cells of the first row of cells and has a width greater than a width of angled struts of the plurality of interconnected struts. Each axial strut includes one or more slots disposed along a length of the axial strut, wherein the one or more slots extend through a portion of the width of the axial strut.

[0019] In another representative example, a prosthetic heart valve comprises a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end and an outflow end of the frame, the plurality of rows of cells comprising a first row of cells disposed at the outflow end and a plurality of axial struts, each axial strut defining an axial side of two adjacent cells of the first row of cells and having a width greater than a width of angled struts of the plurality of interconnected struts. Each axial strut includes a plurality of slots or recesses spaced apart along a length of the axial strut, each slot or recess being located in the axial strut.each recess of the plurality of slots extends through a portion of the width of the axial strut.

[0020] In another representative example, a prosthetic heart valve comprises a radially expandable and compressible frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between a first end and a second end of the frame, wherein the plurality of interconnected struts comprises a plurality of first struts defining the first end and a plurality of second struts defining the second end. Each first strut comprises two angled strut portions and a tip region disposed between the two angled strut portions, wherein the tip region is curved between the two angled strut portions and has a reduced width relative to the width of the two angled strut portions.The heart valve prosthesis further comprises a cover element that is wrapped around and covers the tip region of the frame.

[0021] In another representative example, a heart valve prosthesis comprises a radially expandable and compressible annular frame comprising a plurality of interconnected rows of cells disposed between an outflow end and an inflow end of the frame, wherein the plurality of interconnected rows of cells comprises a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end.Each of the plurality of inflow struts comprises two angled strut portions; and a tip portion disposed between the two angled strut portions, the tip portion comprising a curved, axially facing outer surface forming a single curve between axially facing outer surfaces of the two angled strut portions, and an axially facing inner recess recessed inwardly from the axially facing inner surfaces of the two angled strut portions toward the curved outer surface of the tip portion such that a width of the tip portion is smaller than a width of the two angled strut portions, and shoulders formed at both ends of the tip portion transitioning from the smaller width of the tip portion to the width of the two angled strut portions.The heart valve prosthesis further comprises a cover member having a plurality of loops wrapped around and covering at least a portion of the tip region of the frame between the shoulders of the tip region.

[0022] In another representative example, a prosthetic heart valve comprises a radially expandable and compressible annular frame comprising a plurality of interconnected struts defining a plurality of rows of cells disposed between a first end and a second end of the frame, the plurality of interconnected struts comprising a plurality of first struts defining the first end and a plurality of second struts defining the second end, each of the plurality of first struts comprising a tip region; and a skirt disposed around one of an inner surface and an outer surface of the frame and connected to the frame.The skirt includes a first edge extending around a perimeter of the skirt and connected to the first end of the frame, and a plurality of axially extending tabs extending from the first edge and spaced from each other, each tab of the plurality of axially extending tabs wrapping around a corresponding tip portion such that the tip portion is covered.

[0023] The various inventions of this disclosure may be used in combination or individually. This overview or summary is intended to introduce, in simplified form, a selection of concepts that are described further below in the detailed description. This summary is not intended to identify key features or essential characteristics of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a perspective view of a heart valve prosthesis according to an example. Fig. 2 is a side view of an example of a delivery device configured to deliver and implant a radially expandable heart valve prosthesis at an implantation site. Fig. 3 is a perspective view of a heart valve prosthesis according to another example. Fig. 4 is a side view of the heart valve prosthesis of Fig. 3, which is radially compressed on and around a part of a distal end portion of a delivery device. Fig. 5 is a side view of a frame for a prosthetic heart valve according to another example, the frame having tips or tip portions that form a relatively large angle between angled struts of the frame at the inflow or outflow end of the frame and having a relatively large radius of curvature. Fig. 6 is an enlarged view of a portion of the frame of Fig. 5, which shows the angle between the angled struts at the tip areas. Fig. 7 is an enlarged view of a portion of a frame of a prosthetic heart valve having a plurality of commissure windows offset from an outflow end of the frame and disposed toward a lower portion of two adjacent cells of a row of cells at the outflow end of the frame. Fig. 8A is an enlarged view of a portion of an exemplary prosthetic heart valve frame including window strut portions forming a commissure window of the frame and a single opening above the commissure window. Fig. 8B is an enlarged view of a portion of an exemplary frame of a prosthetic heart valve including window strut portions forming a commissure window of the frame and two openings above the commissure window. Fig. 9A is a side view of a portion of a frame having tip regions at the downstream end of the frame and tip regions at the upstream end of the frame, the downstream and upstream tip regions having reduced widths extending over different lengths. Fig. Figure 9B is an enlarged view of one of the exhaust tip areas of the frame of Fig. 9A. Fig. Figure 9C is an enlarged view of one of the inflow tip areas of the frame of Fig. 9A. Fig. 10A is a side view of a portion of a frame having tip portions at both an outflow end and an inflow end of the frame, the tip portions having a reduced width extending a distance along an outflow strut or inflow strut of the frame. Fig. Figure 10B is an enlarged view of one of the tip areas at the outflow end of the frame of Fig. 10A. Fig. Figure 10C is an enlarged view of one of the tip areas at the inflow end of the frame of Fig. 10A. Fig. 11 is a partial view of a frame for a prosthetic heart valve, the frame including axially extending window strut portions defining commissure windows of the frame, according to one example. Fig. Figure 12 shows overlapping partial views of a frame for a heart valve prosthesis in a radially compressed configuration and a radially expanded configuration. Fig. 13 is a perspective view of an example of a prosthetic heart valve including a frame and an outer skirt attached to the frame. Fig. 14A and Fig. 14B show a top portion of the frame of Fig. 10A, wherein the tip portion is rotated or twisted about its axis to form a twisted outer surface. Fig. 15 is a partial view of the frame of Fig. 10A, which shows an exemplary cushioning element connected to and covering at least a portion of a tip region of the frame. Fig. Figure 16A is a partial view of a frame for a prosthetic heart valve showing a tip of the frame having two curved internal depressions separated by a central cusp. Fig. Figure 16B is a detailed view of the single tip of Fig. 16A. Fig. 17 is a partial view of a frame for a prosthetic heart valve showing an enlarged axial strut of the frame, the axial strut having a plurality of slots or recesses. Fig. 18 is a partial view of a second prosthetic heart valve expanded within a previously implanted first prosthetic heart valve and a balloon deflecting adjacent axial struts of the first and second prosthetic heart valves away from each other to create a space for coronary access. Fig. 19 is a partial view of the frame of Fig. 11, wherein the frame includes an axial strut having a plurality of slots or recesses configured to increase compliance of the axial strut. Fig. 20 is a side view of a portion of a frame of a prosthetic heart valve having tip regions and an exemplary cover member wrapped around and at least partially covering at least a portion of the tip regions. Fig. 21 is a side view of a portion of a frame of a prosthetic heart valve having a tip region at a first end of the frame wrapped and covered by an exemplary cover member. Fig. 22 is an end view of the frame part of Fig. 21. Fig. 23 is a side perspective view of a portion of a frame of a prosthetic heart valve having a tip region at a first end of the frame wrapped and covered by another exemplary cover member. Fig. 24 is an end view of the frame part of Fig. 23. Fig. 25 is a side view of a portion of a prosthetic heart valve having a frame and a skirt disposed around a surface of the frame, the skirt having distal flaps configured to wrap around and cover tip regions at a first end of the frame. Fig. 26 is a cross-sectional view of the heart valve prosthesis of Fig. 25. Fig. 27 is a perspective view of a portion of a frame of a prosthetic heart valve from within the frame, showing an exemplary cover member extending around tip regions of the frame and through an outer skirt disposed around an outer surface of the frame such that the cover member covers at least a portion of the tip regions and secures the outer skirt to the frame. Fig. 28A shows a first portion of an exemplary method for using the same cover member to cover tip portions of a frame and attach an outer skirt to the frame, wherein the cover member is used to form a plurality of loops around a first tip portion and through the outer skirt. Fig. 28B shows a second part of the exemplary method for using the same cover member to cover the tip regions of the frame and secure the outer skirt to the frame, wherein the cover member is used to form two knots at the first tip region after the plurality of loops have been formed around the first tip region. Fig. 28C shows a third part of the exemplary method for using the same cover member to cover the lace regions of the frame and secure the outer skirt to the frame, wherein the cover member is used to form whip stitches along an edge portion of the outer skirt between adjacent lace regions and then to form loops around a second lace region. Fig. 29 is a perspective view of a prosthetic heart valve from the exterior of the prosthetic heart valve showing an outer skirt of the prosthetic heart valve attached to an inflow end of the frame with a cover member extending around the tip regions of the frame and through the outer skirt. Fig. 30 is a side perspective view of a portion of a frame of a prosthetic heart valve having an axially extending strut defining a commissure window therein, wherein an end portion of the axially extending strut disposed on one side of the commissure window includes a concave area at a base of an angled strut of the frame to which the axially extending strut connects. Fig. 31 is an enlarged view of a portion of a frame of a prosthetic heart valve showing another example of a concave area located at a transition between an outflow end portion of an axially extending strut of the frame and an angled strut of the frame. DETAILED DESCRIPTIONGeneral Considerations

[0024] For the purposes of this description, certain aspects, advantages, and novel features of the examples of this disclosure are described herein. The methods, systems, and devices described should not be construed as limiting in any way. Rather, this disclosure is directed to all novel and non-obvious features and aspects of the various disclosed examples, both alone and in various combinations and subcombinations with one another. The disclosed methods, systems, and devices are not limited to any particular aspect, feature, or combination thereof, nor do the disclosed methods, systems, and devices require any particular advantage or advantage to be present or any problems to be solved.

[0025] Although the operations of some of the disclosed examples are described in a particular sequential order for ease of illustration, it should be understood that this type of description also involves rearranging them, unless a particular order is required by the specific language or description set forth below. For example, in some cases the operations described sequentially may be rearranged or performed concurrently. For simplicity, the accompanying figures do not show the various ways in which the disclosed methods may be used in conjunction with other methods. Also, the description sometimes uses terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed.The actual processes corresponding to these terms may vary depending on the particular implementation and are readily apparent to a person skilled in the art.

[0026] As used in this application and the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Furthermore, the term "includes" means "comprising." Furthermore, the term "coupled" generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or connected and does not preclude the presence of intermediate elements between the coupled or connected elements unless expressly stated otherwise.

[0027] As used herein, the term "proximal" refers to a position, direction, or part of a device that is closer to the user and farther from the implantation site. As used herein, the term "distal" refers to a position, direction, or part of a device that is farther from the user and closer to the implantation site. For example, proximal movement of a device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), whereas 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). The terms "longitudinal" and "axial" refer to an axis that extends in a proximal and distal direction, unless expressly defined otherwise. Examples of the disclosed technology

[0028] This text describes examples of radially expandable and compressible heart valve prostheses with an annular frame. The heart valve prosthesis may further include a plurality of valve leaflets attached to the frame. In some examples, the valve leaflets may be attached to the frame via commissures formed by connecting pairs of adjacent ends (e.g., commissure flaps) of the valve leaflets.

[0029] In some examples, the frame of the heart valve prosthesis may include a plurality of rows of cells formed by interconnected struts of the frame. The plurality of rows of cells may include a first row of cells located at an outflow end of the frame. In some examples, the cells of the first row of cells are elongated in an axial direction compared to the cells of the remaining rows of cells of the frame.

[0030] The frame may have a plurality of tip portions at both the inlet and outlet ends spaced apart around the perimeter of the frame, each tip portion forming a connection between two angled strut portions at either the inlet or outlet end of the frame. For example, the two angled strut portions and the corresponding tip portion may together form an outlet strut at the outlet end of the frame or an inlet strut at the inlet end of the frame. Each tip portion may curve between the two corresponding angled strut portions and have a width (in a direction perpendicular to the curve of the tip portion) that is less than a width of either of the two angled strut portions.

[0031] In some examples, the tip region may have a length that is at least 25% of the length of the corresponding exhaust strut or inlet strut. Furthermore, in some examples, the tip region may have a larger radius of curvature and define a larger angle (e.g., between 120 and 140 degrees) between the two angled strut sections than conventional tips or apices, which are more pointed or U-shaped. This may result in the tip regions having a relatively low overall height defined in the axial direction (e.g., equal to the width of the tip region, which is smaller than the width of the angled strut sections).

[0032] In some examples, the tip region may consist of two curved internal depressions separated by a microscopic protrusion.

[0033] In this way, the relatively low height of the tip regions can allow the cells at the outflow end of the frame to have a greater axial length, resulting in a larger open area at an outflow end of the cells for blood flow and coronary access. Furthermore, the configuration of the tip regions described above can provide more atraumatic tip regions at the outflow and inflow ends of the frame, thereby reducing interaction between the tip regions and a balloon of a delivery device and / or a delivery sheath.

[0034] Additionally, in some examples, a cushioning or covering member may cover and / or wrap around at least a portion of the tips or apex or tip region at one end of the frame, thereby providing even more atraumatic tip regions or tips and potentially reducing shear forces through a delivery sheath during delivery of the radially compressed heart valve prosthesis to an implantation site via a delivery device.

[0035] The prosthetic valves disclosed herein may be radially compressible and expandable between a radially compressed state and a radially expandable state. Thus, the prosthetic valves may be crimped onto an implant delivery device or held by the device in the radially compressed state during delivery and then expanded to the radially expandable state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery devices and may be implanted via various delivery methods, examples of which are discussed in more detail below.

[0036] Fig. 1 shows a prosthetic heart valve 10 according to one example. Any of the prosthetic valves disclosed herein can be implanted into the native aortic annulus, although in other examples, they can also be implanted into the other native annuli of the heart (e.g., the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves can also be implanted into vessels communicating with the heart, such as the pulmonary artery (to replace the function of a diseased pulmonary valve) or the superior or inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and vessels of a patient. The disclosed prosthetic valves can also be implanted into a previously implanted prosthetic valve (a surgical prosthetic valve or a transcatheter prosthetic heart valve) in a valve-in-valve procedure.

[0037] In some examples, the disclosed prosthetic valves can be implanted into a docking or anchoring device that is implanted into a native heart valve or vessel. In one example, the disclosed prosthetic valves can be implanted into a docking device implanted into the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed in US Publication No. 2017 / 0231756, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted into a docking device that is implanted in or on the native mitral valve, as disclosed in PCT Publication No. WO2020 / 247907, which is hereby incorporated by reference.In another example, the disclosed prosthetic valves may be implanted into a docking device implanted in the 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.

[0038] The valve prosthesis 10 may include four main components: a stent or frame 12, a valve structure 14, an inner skirt 16, and a perivalvular outer sealing element or outer skirt 18. The valve prosthesis 10 may include an inflow end portion 15, an intermediate portion 17, and an outflow end portion 19. The inner skirt 16 may be disposed on and / or connected to an inner surface of the frame 12, while the outer skirt 18 may be disposed on and / or connected to an outer surface of the frame 12.

[0039] The valve structure 14 may include three leaflets 40 that together form a leaflet structure that may be arranged to collapse in a tricuspid configuration, although in other examples, a greater or fewer number of leaflets may be present (e.g., one or more leaflets 40). The leaflets 40 may be attached to one another at their adjacent sides to form commissures 22 of the leaflet structure 14. The lower border or edge of the valve structure 14 may have a wavy, curved arcuate shape and be attached to the inner skirt 16 by sutures (not shown). In some examples, the leaflets 40 may be formed from pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials, as are known in the art and described in U.S. Pat. No. 6,730.118, which is incorporated herein by reference.

[0040] The frame 12 can be radially compressible (collapsible) and expandable (e.g. in the Fig. 1 in its expanded configuration) and a plurality of interconnected struts 24. A plurality of apices 26 are formed at the inflow end portion 15 and the outflow end portion 19 of the frame 12, which apices are spaced apart from one another in the circumferential direction (in Fig. 1, only the tips 26 at the outflow end section 19 are visible. Each tip or apex 26 is formed at a junction between two angled struts 24 either at the inflow end section 15 or at the outflow end section 19. Fig. Figure 1 shows a known frame construction with tips 26 forming a U-shaped bend between the two angled struts 24. In some examples, the angle 30 between the two angled struts 24 connected at the tip 26 may be in the range of 90 to 120 degrees.

[0041] The frame 12 may be formed with a plurality of circumferentially spaced slots or recesses or commissure windows 20 suitable for securing the commissures 22 of the valve structure 14 to the frame. The frame 12 may be constructed from various suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol). If the frame 12 (and thus the valve prosthesis 10) is constructed from a plastically expandable material, it may be crimped onto a delivery catheter or delivery device and then expanded within the patient by an inflatable balloon or equivalent expansion mechanism.If the frame 12 (and thus the prosthetic valve 10) is made of a self-expanding material, it can be crimped into a radially collapsed configuration and secured in the collapsed configuration by insertion into a sheath or equivalent delivery catheter mechanism. Once the prosthetic valve is within the body, it can be pushed out of the sheath, allowing the prosthetic valve to expand to its functional size.

[0042] Suitable plastically expandable materials that can be used to fabricate frame 12 include, but are not limited to, stainless steel, biocompatible, high-strength alloys (e.g., cobalt-chromium or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In particular examples, frame 12 is made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N® alloy (SPS Technologies, Jenkintown, Pennsylvania), which conforms to UNS R30035 alloy (ASTM F562-02). MP35N® alloy / UNS R30035 alloy consists of 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum (by weight). Further details of the valve prosthesis 10 and its various components are described in WIPO patent application No. WO 2018 / 222799, which is incorporated herein by reference.

[0043] Fig. Figure 2 shows a delivery device 100 according to an example that can be used to implant an expandable valve prosthesis (e.g., the valve prosthesis 10 of Fig. 1 or any of the other prosthetic valves described herein). In some examples, the delivery device 100 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0044] The feeding device 100 in the Fig. The example illustrated in Figure 2 is a balloon catheter having 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 from the handle 102 and distally from the handle 102, wherein the portion extending distally from the handle 102 also extends coaxially through the outer shaft 104. Additionally, the delivery device 100 may further include an inner shaft 108 extending coaxially through the intermediate shaft 106 and the outer shaft 104 distally from the handle 102 and coaxially through the intermediate shaft 106 proximally from the handle 102.

[0045] The outer shaft 104 and the intermediate shaft 106 may be configured to translate (e.g., move) relative to each other longitudinally along a central longitudinal axis 120 of the delivery device 100 to facilitate the delivery and positioning of a valve prosthesis at an implantation site in a patient's body.

[0046] The intermediate shaft 106 may include a proximal end portion 110 that extends proximally from a proximal end of the handle 102 to an adapter 112. A rotatable knob 114 may be attached to the proximal end portion 110 and may be configured to rotate the intermediate shaft 106 about the central longitudinal axis 120 and relative to the outer shaft 104.

[0047] The adapter 112 may include a first port 138 configured to receive a guidewire and a second port 140 configured to receive a fluid (e.g., inflation fluid) from a fluid source. The second port 140 may be fluidly connected to an inner lumen of the intermediate shaft 106.

[0048] The intermediate shaft 106 may further include a distal end portion that extends distally beyond a distal end of the outer shaft 104 when a distal end of the outer shaft 104 is positioned away from an inflatable balloon 118 of the delivery device 100. A distal end portion of the inner shaft 108 may extend distally beyond the distal end portion of the intermediate shaft 106.

[0049] The balloon 118 may be connected to the distal end portion of the intermediate shaft 106.

[0050] In some examples, a distal end of the balloon 118 may be coupled to a distal end of the delivery device 100, such as with a nose cone 122 (as shown in Fig. 2), or with an alternative component at the distal end of the delivery device 100 (e.g., a distal shoulder). An intermediate portion of the balloon 118 may overlie a valve attachment portion 124 of a distal end portion of the delivery device 100, and a distal end portion of the balloon 118 may overlie a distal shoulder 126 of the delivery device 100. The valve attachment portion 124 and the intermediate portion of the balloon 118 may be configured to receive a heart valve prosthesis in a radially compressed state. For example, as shown in Fig. 2, a prosthetic heart valve 150 (which may be one of the prosthetic valves described herein) may be mounted around the balloon 118 on the valve attachment portion 124 of the delivery device 100.

[0051] The balloon shoulder assembly, including the distal shoulder 126, is configured to hold the prosthetic valve 150 (or other medical device) in a fixed position on the balloon 118 during transport through the patient's vasculature.

[0052] The outer shaft 104 may have a distal head portion 128 attached to its distal end. The outer shaft 104 and the intermediate shaft 106 may be axially displaceable relative to each other to position the distal head portion 128 near a proximal end of the valve attachment portion 124 when the valve prosthesis 150 is in the radially compressed state on the valve attachment portion 124 (as shown in Fig. 2) and secured during delivery of the prosthetic valve to the target implantation site. As such, the distal head portion 128 may be configured to resist movement of the prosthetic valve 150 relative to the balloon 118 in a proximal direction with respect to the balloon 118 when the distal head portion 128 is disposed adjacent a proximal side of the valve attachment portion 124.

[0053] An annular space may be defined between an outer surface of the inner shaft 108 and an inner surface of the intermediate shaft 106 and may be configured to receive fluid from a fluid source via the second port 140 of the adapter 112. The annular space may be in fluid communication with a fluid passage formed between the outer surface of the distal end portion of the inner shaft 108 and an inner surface of the balloon 118. Thus, fluid from the fluid source may flow from the annular space to the fluid passage to inflate the balloon 118 and radially expand and deploy the prosthetic valve 150.

[0054] An inner lumen of the inner shaft may be configured to receive a guidewire therethrough to navigate the distal end portion of the delivery device 100 to the target implantation site.

[0055] The handle 102 may include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery device 100. In the example shown, the handle 102 includes, for example, an adjustment member, such as the rotatable knob 160 shown, which in turn is operatively connected to the proximal end portion of a puller wire. The puller wire may extend distally from the handle 102 through the outer shaft 104 and has a distal end portion attached to the outer shaft 104 at or near the distal end of the outer shaft 104. By rotating the knob 160, the pulling force in the puller wire may be increased or decreased, thereby adjusting the curvature of the distal end portion of the delivery device 100. Further details regarding steering or bending mechanisms for the delivery device can be found in U.S. Patent No. 9,339,384, which is incorporated herein by reference.

[0056] The handle 102 may further include an adjustment mechanism 161 with an adjustment element, such as the illustrated rotatable knob 162, and an associated locking mechanism with another adjustment element, embodied 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 Application Nos. 63 / 069,567 and 63 / 138,890, which are incorporated herein by reference.

[0057] Fig. Figure 3 shows an example of a prosthetic valve 200 comprising a radially expandable and compressible annular frame 202 and a plurality of leaflets 204 attached to the frame. Each leaflet 204 may include opposing commissure flaps disposed on opposite sides of the leaflet 204 and a cusp portion extending between the opposing commissure flaps.

[0058] The frame 202 may be made of various suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel-titanium alloy (NiTi), such as Nitinol) as are known in the art. In some examples, the frame 202 is made of a plastically expandable material as described above with reference to the valve prosthesis 10 of Fig. 1 was described.

[0059] The frame 202 may include a plurality of interconnected struts 206 forming a plurality of rows of open cells 208 between an outflow end 210 and an inflow end 212 of the frame 202. In some examples, as in Fig. 3, the frame 202 may comprise three rows of cells 208, wherein a first (e.g., upper in Fig. 3) Row of cells 214 located at the outflow end 210 has cells 208 that are elongated in an axial direction (relative to a central longitudinal axis 216 of the frame 202) compared to the cells 208 in the remaining rows of cells. For example, the cells 208 of the first row of cells, or row of cells 214, may have a greater axial length, defined in a direction of a central longitudinal axis 216 of the frame 202, than the cells 208 in the remaining rows of cells (e.g., cells in the row of cells at the inflow end 212).

[0060] In some examples, such as Fig. 3, each row of cells 208 comprises nine cells. Therefore, in such examples, frame 202 may be referred to as a nine-cell frame.

[0061] In other examples, frame 202 may include more than three rows of cells (e.g., four or five) and / or more or fewer than nine cells per row. In some examples, cells 208 in the first row of cells 214 may not be elongated compared to cells 208 in the remaining rows of cells of frame 202.

[0062] The interconnected struts 206 may include a plurality of angled struts 218, 234, 236, and 238 arranged in a plurality of circumferentially extending rows of angled struts, the rows being 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 row of angled struts 238 arranged end-to-end and extending circumferentially at the inflow end 212 of the frame, a second row of circumferentially extending angled struts 236, a third row of circumferentially extending angled struts 234, and a fourth row of circumferentially extending angled struts 218 at the outflow end 210 of the frame 202.The fourth row of angled struts 218 may be connected to the third row of angled struts 234 by a plurality of axially extending window strut portions 240 and a plurality of (e.g., axially extending) axial struts 232. The axially extending window strut portions 240 define commissure windows (e.g., open windows) 242 that are circumferentially spaced from each other around the frame 202 and that are adapted to receive a pair of commissure tabs of a pair of adjacent valve leaflets 204 disposed within a commissure 230.

[0063] One or more (e.g. two, as in Fig. 3) Axial struts 232 may be arranged circumferentially between two commissure windows 242 formed by the window strut sections 240. Since the frame 202 is smaller than other valve prostheses, such as the valve prosthesis 10 of Fig. 1, fewer cells per row (e.g., nine) and fewer axial struts 232 between each commissure window 242, each cell 208 may have a greater width (circumferentially), thereby providing a larger opening for blood flow and / or coronary access, as described herein.

[0064] Each axial strut 232 and each window strut section 240 extends from a location defined by the convergence of the lower ends (e.g., ends located inward of and farthest from the outflow end 210) of two angled struts 218 (which may also be referred to as an upper strut connection or upper elongated strut connection) to another location defined by the convergence of the upper ends (e.g., ends located closer to the outflow end 210) of two angled struts 234 (which may also be referred to as a lower strut connection or lower elongated strut connection). Each axial strut 232 and each window strut section 240 forms one axial side of two adjacent cells of the first row of cells 214.

[0065] In some examples, such as Fig. 3, each axial strut 232 may have a width 244 that is greater than a width of the angled struts 218, 234, 236, and / or 238. As used herein, the "width" of a strut is measured between opposite locations on opposite surfaces of a strut that extend between the radially facing inner and outer surfaces of the strut (relative to the central longitudinal axis 216 of the frame 200). The "thickness" of a strut is measured between opposite locations on the radially facing inner and outer surfaces of a strut and is perpendicular to the width of the strut. In some examples, the width 244 of the axial struts 232 is 50-200%, 75-150%, or at least 100% greater than the width of the angled struts of the frame 202 (e.g., twice).For example, if the angled struts 218, 234, 236, and 238 are approximately 0.3 mm wide, then the width 244 of the axial struts 232 may be in a range of 0.45 mm - 0.9 mm, 0.5 mm - 0.75 mm, or at least 0.6 mm. In some examples, the width 244 of the axial struts 232 may be in a range of 0.5 mm - 1.0 mm.

[0066] In known valve prostheses (such as the one in Fig. For example, in the valve 10 shown in Figure 1), the axial struts have the same width as the other struts (e.g., the angled struts) of the frame. However, when the valve leaflets of the prosthetic valve are pressed against the frame during the systolic phase, the valve leaflets may bulge radially outward through the cell openings around the struts during implantation and use due to the relatively reduced width of the axial struts. This phenomenon may compromise the long-term durability of the valve leaflets, particularly if the upper (e.g., the outflow) edges of the valve leaflets press against the axial struts and become bent over, as described above.

[0067] By providing the axial struts 232 with a width 244 that is greater than the width of other, angled struts of the frame 202, a larger contact area is provided when the valve leaflets 204 contact the wider axial struts 232 during systole, thereby distributing the load and reducing the extent to which the valve leaflets 204 can fold radially outward through the cells 208 beyond the axial struts 232. This may increase the long-term durability of the valve leaflets 204.

[0068] In some cases, the free edges or margins at the outflow end 228 of the valve leaflets 204 may press against the axial struts 232 at their outflow end sections (e.g., the upper end sections) 246. However, these outflow end sections 246 may be even wider than the width 244 (as in Fig. 3), thereby providing an even larger contact and support surface for the valve leaflets 204.

[0069] As introduced above, the frame 202 can be compared to the valve prosthesis of Fig. 1 fewer cells in the circumferential direction (e.g. nine in Fig. 3), and each cell 208 may have a larger width (measured circumferentially). This larger width of the cells 208 of the first row of cells 214 may allow the wider axial struts 232 to be incorporated into the frame 202 without reducing the open area for blood flow and / or coronary access.

[0070] Commissure flaps of adjacent valve leaflets 204 may be connected to each other to form commissures 230. Each commissure 230 of the prosthetic heart valve 200 includes two paired commissure flaps, one from each of the two adjacent valve leaflets 204, extending through a commissure window 242 of the frame 202. Each commissure 230 may be attached to the window strut portions 240 that form the commissure window 242.

[0071] The sail edge portion (e.g., the scalloped or scalloped edge) of each flap sail 204 may be attached to the frame via one or more fasteners (e.g., stitching). In some examples, as in Fig. 3, the leaflet edge portion of each leaflet 204 may be directly attached to the struts of the frame 202 (e.g., the angled struts 234, 236, and 238). For example, the leaflet edge portions of the leaflets 204 may be sewn to the angled struts 234, 236, and 238, which generally follow the contour of the leaflet edge portions of the leaflets.

[0072] In some examples, the leaflet edge portion of the flap leaflets 204 may be attached to an inner skirt, and the inner skirt may then be attached directly to the frame 202.

[0073] Further, in some examples, an outer skirt may be connected to an outer surface of the frame 202 (e.g., similar to the outer skirt 18 of the valve 10 of Fig. 1).

[0074] As in Fig. 3, in some examples, one or more or each of the axial struts 232 may include an inflow end portion 248 (e.g., an inflow end portion that is closer to the inflow end than the outflow end portion 246) that is widened relative to a middle portion 247 of the axial strut 232 (which may be defined by the width 244), similar to the outflow end portion 246 (as described above). In some examples, the inflow end portion 248 of the axial strut 232 may include an opening 249. The openings 249 may be configured to receive fasteners (e.g., sutures) to attach soft components of the valve prosthesis 200 to the frame 202. For example, in some cases, an outer skirt may be positioned around an outer surface of the frame 202 and attached to the openings 249 (e.g., as shown in Fig. 13 and described below).

[0075] 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 connection between two angled struts 218 at the inflow end 212 or the outflow end 210. The tips 220 are circumferentially spaced from each other at the inflow end 212 and the outflow end 210. As shown in Fig. 3, each tip 220 may have side portions 222 that bend or curve axially outward from the angled strut 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 portion 224 may be relatively flat and have a surface disposed perpendicular to the central longitudinal axis 216. Each tip 220 may have two bends at its end portion 224 and two bends at the side portions 222 (e.g., one at the junction between each side portion 222 and the angled strut 218). In this manner, the tips 220 may be U-shaped, similar to the tips 26 of the valve of Fig. 1.

[0076] While tips 220 with such a shape can distribute the stresses at the tips 220 across the angled struts 218 to which they are connected, such a shape results in the height (in the axial direction) 221 of the tips 220 at the inflow end 212 and the outflow end 210 being added to the overall height of the valve prosthesis 200. As a result, the inflow end 226 of the valve leaflets 204 is spaced from the inflow end 212 of the frame 202. This, in turn, can result in the outflow end 228 of the valve leaflets 204 being located closer to the outflow end 210 of the frame, resulting in less clearance in the cells 208 of the upper row of cells 214 between the outflow edges of the valve leaflets and the upper row of struts 218. In some examples, this arrangement may cause the valve leaflets 204, including the commissures 230 of the adjacent commissure lobes of the valve leaflets 204, to at least partially block blood flow into the coronary ostia.Furthermore, devices for re-accessing the coronary arteries can be prevented from passing through such small spaces.

[0077] Fig. Figure 4 shows the valve prosthesis 200 radially compressed onto and around a portion of a distal end section of a delivery device 250 (which may be the same as or similar to the delivery device 100 of Fig. 2). As in Fig. 4, the valve prosthesis 200 is compressed radially around a portion of an inflatable balloon 252 of the delivery device 250 (the inflatable balloon 252 may be similar to the balloon 118 of Fig. 2). In some examples, as in Fig. 4, the prosthetic valve 200 may be crimped onto the distal end portion of the delivery device 250 with the inflow end 212 facing a nose cone 254 of the delivery device 250. In other examples, the prosthetic valve 200 may be crimped onto the distal end portion of the delivery device 250 with the outflow end portion 210 facing a nose cone 254.

[0078] In such a configuration, at least the tips 220 are exposed at the inflow end 212, which may result in abrasion of the tips 220 against or penetration of the tips 220 into an inner wall of a delivery sheath through which the delivery device 250 passes en route to the implantation site (e.g., during delivery of the prosthetic valve 200 to the target implantation site). For example, when the prosthetic valve 200 is radially compressed (e.g., crimped) around the delivery device 250 during an implantation procedure, the prosthetic valve 200 may be pushed through an inner lumen of the delivery sheath, and the tips 220 may contact, puncture, or tear the walls of the delivery sheath.

[0079] In some examples, the exposed tips 220 may interact with the balloon 252. For example, if the prosthetic valve 200 is crimped outside an inflatable portion of the balloon 252, the flow tips 220 may interact with the balloon 252 (e.g., scratch it or resist movement of the valve over the balloon) upon reaching the implantation site as the prosthetic valve 200 is slid over the inflatable portion of the balloon 252.

[0080] To address the problems described above with such U-shaped or more pointed tips that add height to the inflow and outflow ends of the valve prosthesis, a valve prosthesis frame may instead have tips or tip regions that form a larger angle between the angled struts (or angled strut sections) at the inflow or outflow end of the frame and have a larger radius of curvature, resulting in a more curved or flattened shape (e.g., less sharp-edged, as shown in the Fig. 1 and Fig. 3), which may be more atraumatic for the delivery device balloon and delivery sheath. Furthermore, as discussed below, such tip regions may provide a lower axial height at the inflow and outflow ends of the prosthetic valve, allowing the inflow ends (e.g., the inflow end of the end portion of the leaflets) of the valve leaflets to be positioned closer to the inflow end of the frame, thus creating a larger open area at the outflow end portion of the prosthetic valve for improved blood flow and coronary access.

[0081] Fig. 5 shows an exemplary frame 300 for a valve prosthesis comprising interconnected struts 302 forming tips (or tip regions) 304 at an inflow end 306 and outflow end 308 of the frame 300. As in Fig. 5 and the enlarged view of a part of the frame 300 of Fig. 6, each tip 304 is sandwiched between two angled struts 310 (similar to the angled struts 218 and 238 of the frame 202 of Fig. 3) is arranged at the inflow end section 306 or outflow end section 308 of the frame 300 and forms a transition between them.

[0082] Each 304 tip can be compared to the 220 tips of Fig. 3 have a flatter (e.g., less pointed) shape. For example, each tip 304 may have a curved or relatively flat outer surface 312 and an arcuate or curved inner recess 314 disposed opposite the outer surface 312 ( Fig. 6). The inner recess 314 forms a narrow area at the tip 304 with a width 316 that is smaller than the width 318 of the angled struts 310 ( Fig. 6). This narrow region of the tip 304 can distribute stresses to which the frame 300 is subjected away from the tip and across the two angled struts 310 extending from either side of the tip 304.

[0083] Each tip 304 of the frame 300 ( Fig. 5 and Fig. 6) may have a lower height compared to each tip 220 of the frame 202 ( Fig. 3). For example, Fig. 3 a height difference 322 between the inflow end 212 of the frame 202 (at the tip 220), due to the more flattened tips 304 of the frame 300, and the location where the inflow end 306 of the frame 300 would be located in comparison. As a result, the inflow end 226 of the valve leaflets 204 can be positioned closer to the inflow end 306 of the frame 300 than in the frame 202. In some examples, with the same overall valve height for the frame 300 and the frame 202, this allows the cells of the frame 300, in particular the first row of cells 324 located at or near the outflow end 308, to be extended in the axial direction. For example, in some cases, an axial height 326 of the first row of cells 324 ( Fig. 5) by approximately twice the height 221 of the more U-shaped and axially aligned tips 220 of the frame 202 ( Fig. 3) be elevated relative to the axial height of the first row of cells 214 of frame 202. This "higher" or longer first row of cells 324 of frame 300 may have a larger portion exposed above the outflow end of the valve leaflets, thereby creating more open space for blood flow at the outflow end of frame 300 and reducing the risk of sinus sequestration.

[0084] In some examples, such as Fig. 6, an angle (e.g., the tip angle) 320 between the two angled struts 310 connected at the tip 304 may be greater than 120 degrees. In some examples, the angle 320 may be in a range of 120 (not including) to 140 degrees (e.g., such that the angle 320 is greater than 120 degrees). In some examples, the angle 320 may be in a range of 135-140 degrees, 138-140 degrees, or 139-140 degrees. In some examples, the angle 320 may be approximately 140 degrees (e.g., ±1 degree).

[0085] In some examples, a balloon-expandable valve comprising the frame 300 may be deployed by inflating a balloon of a delivery device around which the prosthetic valve is mounted (e.g., such as the delivery device of Fig. 2), radially expanded and deployed at a target implantation site. After such deployment, due to a low inherent elasticity of the metal from which the frame 300 is constructed, the frame tends to recoil radially inward (toward a central longitudinal axis of the frame) to an expanded diameter slightly smaller than the diameter defined by the inflated balloon (of the delivery device) once the balloon is deflated and no longer exerts a radially outward force on the frame 300. It may be desirable to keep this radial recoil to a range of less than five percent of the diameter of the heart valve prosthesis as it radially expands over the inflated balloon.Reducing the radial rebound from the diameter of the valve on the inflated balloon to the diameter of the valve after balloon deflation may provide better predictability of the final expanded diameter of the valve.

[0086] The angle 320 at the tip 304 can influence the degree of retraction of the frame 300 after radial expansion of the frame of the heart valve prosthesis by inflation and deflation of the balloon. For example, larger angles at the tip (e.g., greater than 120 and up to 140 degrees) can result in a lesser degree of radial retraction compared to smaller angles at the tip (e.g., between 90 and 120 degrees).

[0087] Tips 304 that create the angle 320 between the angled struts 310 in the range described above (e.g., greater than 120 degrees and up to 140 degrees) can result in a radial recess at the inflow end 306 and outflow end 308 in the range of 0.3-0.4 mm for a valve prosthesis with an expanded working diameter of 20 mm, which is less than half the radial recess that can occur in the midsection of the valve (e.g., in a range of 0.95-0.97 mm). The radial recess at the inflow end 306 and outflow end 308 of the frame 202 can also be significantly less than the radial recess of a valve with more conventional tips and tip angles of 120 degrees or less (e.g., such as the valve 10 of Fig. 1), which can be in the range of 0.7-0.8 mm.

[0088] Advantageously, the configuration of the tips 304 as described above allows for an increase in the tip angle 320 beyond that of conventional U-shaped tip angles, thereby reducing the amount of radial recession of the frame 300. Furthermore, the increased angle and shape of the tips 304 (e.g., reduced height and curved or arcuate shape as described above) provide tips 304 that are more atraumatic (compared to more pointed and / or U-shaped tips, such as those in Fig. 1 and Fig. 3). As a result, the risk of the tips 304 interacting with and / or damaging the delivery sheath and / or inflatable balloon of the delivery device, as well as the native anatomy, can be reduced.

[0089] Apart from the configuration of the tips 304, the frame 300 can be similar to the frame 202 of Fig. 3. For example, the frame 300 may include a first row of cells 324 defined by the angled struts 310 at the outflow end 308, the angled struts 234 and the window strut portions 240, and the axial struts 232.

[0090] In some examples, such as Fig. 5 and Fig. 6, one or more or each of the axial struts 232 may have the increased width 244 as described above with reference to Fig. 3. Further, one or more or each of the axial struts 232 may include the opening 249 in the inflow end portion 248.

[0091] In some examples, a commissural window 342, instead of being centered along the window strut portions 240 and between two adjacent cells of the upper row of cells 324 (e.g., as in Fig. 5), along a lower portion of the axial struts forming the axial sides of the two adjacent cells of the first row of cells 324, as shown in Fig. 7. In other words, the commissure window 342 may be spaced away from the outflow end 308 of the frame 300 and toward a lower portion of the two adjacent cells of the first row of cells 324.

[0092] Fig. For example, Figure 7 shows a portion of an example of the frame 300 with the commissural window 342 lowered within the first row of cells 324 (compared to the Fig. 5). The gap window 342 is formed and defined between a first, axially extending window strut portion 340a and a second, axially extending window strut portion 340b. As shown in Fig. 7, a length 344 of the axially extending window strut portions 340a and 340b is shorter than a length 346 of the axial struts 232. The axially extending window strut portions 340a and 340b are formed integrally with the frame 300 and each extend from an upper (e.g., proximal) axial strut 348. Together, the axially extending window strut portions 340a and 340b and the upper axial strut 348 can form an axially extending frame portion that defines an axial side of each two adjacent elongated cells 350 of the upper row of cells 324.

[0093] In some examples, the width of the upper axial strut 348, defined circumferentially and perpendicular to the central longitudinal axis of the frame, may be the same as the width of the axially extending window strut portions 340a and 340b and / or additional struts of the frame (e.g., the angled struts 310).

[0094] In some examples, the width of the upper axial strut 348 may be greater (e.g., thicker) than the width of the axially extending window struts 340a and 340b and / or additional struts of the frame (e.g., the angle struts 310).

[0095] In some examples, the upper axial strut 348 may have additional geometric features, such as one or more holes or notches along its length.

[0096] The upper axial strut 348 is disposed between an upper (e.g., proximal) elongated strut connection 352 (e.g., the connection between two angled struts 310 and the upper axial strut 348) and an upper edge 354 of the commissure window 342. The upper edge 354 is disposed substantially perpendicular to the upper axial strut 348 and laterally (e.g., circumferentially) offsets the axially extending window strut portions 340a and 340b from each other. In other words, the upper edge 354 may extend circumferentially (or laterally) between the upper ends of the axially extending window strut portions 340a and 340b.As used herein, "upper" ends, struts, or edges may refer to ends, struts, or edges of components located closer to a proximal or outflow end 308 of the frame 300, and "lower" ends, struts, or edges may refer to ends, struts, or edges of components located farther from the outflow end 308 and toward the inflow end 306.

[0097] As in Fig. 7, in some examples, the lower elongated strut connection that would connect the lower ends of the strut sections 340a, 340b is replaced by an open, lower end of the commissure window 342. In some cases, for example, each axially extending window strut section 340a and 340b includes a lower clamping section 356a and 356b, respectively, formed by a lower, curved (e.g., angled) portion of the respective axially extending window strut sections 340a and 340b. As shown in Fig. 7, the bends of the lower clamping sections 356a and 356b are angled to each other. As shown in Fig. 7, the lower clamping portions 356a and 356b may therefore together form a neck region at the lower end of the open commissure window 342.

[0098] In some examples, the commissure tabs of one commissure may extend through the open commissure window 342 to form a commissure assembly (e.g., a commissure mounted on the frame 300). For example, in some cases, commissure tabs of two adjacent valve leaflets may be inserted into the commissure window 342 through an opening defined between the lower clamping portions 356a and 356b.

[0099] In some examples, the axially extending window struts 340a and 340b and their respective lower clamping portions 356a and 356b may be laterally bent or resiliently curved (e.g., laterally outward and away from each other) during deployment of the valve leaflets.

[0100] In some examples, a suture may be wrapped or looped around the lower clamping portions 356a and 356b (e.g., wrapped or looped around outer bends in each of the lower clamping portions) once the commissure tabs are positioned within the commissure window 342 to clamp the lower ends of the axially extending window struts 340a and 340b together and prevent the commissure tabs from sliding axially out of the commissure window 342. In alternative examples, alternative fastening or clamping means (e.g., straps, cords, knots, or the like) may be used to clamp the lower clamping portions 356a and 356b together.

[0101] In other examples, the lower end of each commissure window 342 may be closed and formed by a lower elongated strut connection (e.g., similar to connection 352).

[0102] Furthermore, in some examples, the axial position (along the central longitudinal axis of the frame 300) of the upper edge 354 or the axial distance between the upper edge 354 and the outflow end portion 308 of the frame can be selected such that all or at least a majority of the valve leaflets remain within a lower portion 358 of the cells of the first row of cells 324 and an upper portion 360 of the cells of the upper row of cells 324 remains substantially unblocked by the valve leaflets. In this way, the commissure window 342 and thus the valve leaflets are axially offset toward an inflow end (which may also be referred to as the upstream end) of the first row of cells 324.This substantially increases the area for blood flow and / or access via a re-access device through the upper (or downstream) portions 358 of the first row of cells 324 during operation of the valve.

[0103] For example, in some cases, a length 362 of the upper axial strut 348 may be selected to provide an axial distance 364 between the outflow end 308 of the frame 300 and the outflow edges of the valve leaflets at the commissure (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 examples, the selected range of the axial distance 364 is in a range of 2-6 mm, 2-4 mm, or 2-3 mm. In some examples, the selected range of the axial distance 364 is in a range of 20-50%, 25-45%, or 30-40% of the total axial distance (or height) 326 ( Fig. 5) the elongated cells 350. In some examples, the length 362 of the upper axial strut 348 may be in a range of 0.75-2.5 mm, or 1-2 mm, or about 1.5 mm. Consequently, the upper portion 358 of the cells of the first row of cells 324 may be sized to provide adequate blood flow and / or access via a re-access device.

[0104] In some examples, the outflow edges of the valve leaflets remote from the commissure (and commissure tabs) may be higher (closer to the outflow end 308) or lower toward the center of the valve (toward the central longitudinal axis of the frame) than the outflow edges of the valve leaflets at the commissure tabs.

[0105] In some examples, the outflow edges of the valve leaflets remote from the commissure (and commissure tabs) may also be offset toward the center of the valve (toward the central longitudinal axis of the frame) by the axial distance 364 from the outflow end 308 of the frame 300.

[0106] Fig. Figure 8A shows another example of the window strut sections that form the commissure windows 242 of the frame 300. As in Fig. 8A, in some examples, the commissure window 242 may be formed by axially extending window strut portions 370a and 370b (e.g., an axially extending strut) extending between angled struts 310 at the outflow end 308 and angled struts 234. In some examples, the window strut portions 370a and 370b are integrally formed and may collectively be referred to as an axially extending window strut or window strut portion forming the commissure window 242. The window strut portions 370a and 370b may have the configuration shown in Fig. 5, but are configured such that the commissure window 242 defined by them is displaced downwards, toward the angled struts 234 (and the inflow end of the valve). As shown in Fig. 8A, the window strut portions 370a and 370b may, for example, form a first or upper end portion 372 above the commissure window 242 (e.g., the end portion closer to the outflow end 308) and a second or lower end portion 374 below the commissure window 242 (e.g., the end portion farther from the outflow end 308), with the upper end portion 372 being larger (or thicker) in the axial direction than the lower end portion 374. Therefore, in some examples, the upper end portion 372 may include an opening 376. In some examples, the opening 376 may be configured to receive one or more fasteners (e.g., sutures) when the commissure tabs of the valve leaflets are attached to the frame within the commissure window 242.

[0107] In some examples, the upper end portion 372 may have more than a single opening 376, such as two or more openings. Fig. For example, Figure 8B shows another exemplary configuration of window strut sections 1502a, 1502b (forming an axially extending strut) forming a commissure window 1504 of a frame 1500 of a valve prosthesis. An upper end portion 1506 (which may also be referred to herein as an "outflow end portion") of the window strut sections 1502a, 1502b (in Fig. 8B (located above the commissure window 1504) includes two openings 1508 disposed therein. The frame 1500 may be similar to any of the frames disclosed herein, such as frame 400 or 500 (as described further below). However, the configuration of the window strut portions 1502a, 1502b and the upper end portion 1506 with the two openings 1508 may be included in many different frames, such as any of the frames disclosed herein. The two openings 1508 may be configured to receive one or more sutures or other fasteners used to secure commissure tabs of adjacent valve leaflets within the commissure window 1504. In some cases, the commissure tabs (forming a commissure) may be more easily and reliably attached to the commissure window 1504 by using two openings 1508 (instead of just one).

[0108] Back to Fig. 5 and Fig. 6: In some examples, the formation of a narrow region above the tip 304 may result in high stresses developing in the center of the narrow region (e.g., in the center of the tip), which may reduce the strength of the tip. For example, in the frame 300 with the tips 304 ( Fig. ) the point of maximum stress during radial expansion of frame 300 will occur at tips 304, as indicated by dashed circle 330 in Fig. shown. In some examples, the maximum stress at point 330 may be up to 2,140 MPa. It may be desirable to provide a frame for a valve prosthesis in which the maximum stress during expansion does not exceed 2,000 MPa. In some examples, it is desirable for the maximum stress experienced by the frame during expansion to be less than 1,700 MPa.

[0109] Therefore, there is a need to provide a tip or tip area with a lower height, similar to those shown in the Fig. 5 and Fig. 6, but which reduces the strain concentrations in the tip region and / or moves the maximum stresses occurring during radial expansion of the frame away from the tips.

[0110] In one example, the strain concentrations and / or maximum stresses observed at the tips of frames with reduced height tips or tip regions with thinned areas (such as those shown in Fig. 5 and Fig. 6) can be reduced by modifying the tip regions of the frame to have a reduced width (relative to angled struts of the frame) that extends over a greater length of the inlet or outlet strut that includes the tip region (e.g., at least 25% of a length of the inlet or outlet strut). Exemplary examples of such frame configurations are shown in the Fig. 9A-9C and 10A-10C as described below.

[0111] Fig. 9A-9C show an example of a portion of the frame 400 having outflow tip regions 402 (one in Fig. 9A and Fig. 9B) at an outflow end 406 of the frame 400 and inflow tip regions 404 (one in Fig. 9A and Fig. 9C) at an inflow end 408 of the frame 400. In some examples, the outflow end 406 may include a plurality of outflow struts 460, each outflow strut 460 having an outflow tip region 402 and two angled strut sections 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 the Fig. 5 and Fig. 6) at the outflow end 406 of the frame 400. For example, each outflow tip region 402 may curve between two angled window strut sections 410, with each window strut section extending between the outflow tip region 402 and a different axial strut 232 (as shown in Fig. 9A) or a window strut portion. Similarly, the inflow end 408 may include a plurality of inflow struts 462, each inflow strut 462 including an inflow tip portion 404 and two angled strut portions 410 at the inflow end 408 of the frame 400.

[0112] Each of the outflow tip regions 402 and inflow tip regions 404 may include a tip 412 (the highest or most outwardly extending point in the axial direction) and narrow (or constricted) strut sections 414 extending from either side of the tip 412 and connected to corresponding angled strut sections 410 ( Fig. 9B and Fig. 9C). In this manner, each of the outflow tip regions 402 and the inflow tip regions 404 may form a narrowed transition region between and relative to the two angled strut portions 410 extending from the corresponding tip region.

[0113] In some examples, each of the outflow tip regions 402 and the inflow tip regions 404 may include transition sections 420 ( Fig. 9B) that taper or narrow in width from the corresponding angled strut portion 410 to the corresponding narrow strut portion 414.

[0114] In other examples, the outflow tip regions 402 and the inflow tip regions 404 may not include the transition sections 420, and instead, the transition sections 420 may be included in the corresponding angled strut portions 410.

[0115] The narrow strut sections 414 of the outflow tip region 402 and the inflow tip region 404 may have a width 416 that is smaller than a width 418 of the angled strut sections 410 ( Fig. 9B and Fig. 9C). In some examples, the width 416 may be a uniform width (e.g., along the entire length of the strut portion 414). As introduced above, the width of a strut portion (as used herein with reference to the width 416 of the narrow strut portions 414 and the width 418 of the angled strut portions 410) is measured between opposing locations on opposing surfaces of a strut portion that extend between the radially facing inner and outer surfaces of the strut portion.

[0116] In some examples, the width 416 of the narrower strut sections 414 may be about 0.06 - 0.15 mm smaller than the width 418 of the angled strut sections 410. For example, in some cases, the width 418 of the angled strut sections 410 may be about 0.3 mm and the width 416 of the narrower strut sections 414 may be in a range of about 0.15 - 0.24 mm. In some examples, the width 416 of the narrow strut sections 414 may be in a range of about 0.18 to 0.22 mm. In some examples, the width 416 of the narrow strut sections 414 may be about 0.2 mm (e.g., ± 0.03 mm). The width 416 may also be referred to as the width of the outflow tip region 402 and the inflow tip region 404.

[0117] In contrast to the tips of the frame 300 ( Fig. 5 and Fig. 5) the outflow tip regions 402 and the inflow tip regions 404 of the frame 400 ( Fig. 9A-9C) have the narrower strut sections 414 extending over a greater distance between the angled strut members 410. For example, the narrow strut sections 414 of the discharge tip regions 402 may have a first length 422 ( Fig. 9B). In some examples, the first length is in a range of 0.8-1.4 mm, 0.9-1.2 mm, or 0.95-1.05 mm. In some examples, the first length is about 1.0 mm (e.g., ±0.03 mm). Thus, narrow strut portions 414 located on either side of and extending from the tip 412 of the discharge tip region 402 may have the first length 422 (in Fig. 9B, only a first length 422 is shown.) In other words, each discharge tip region 402 may include two narrow strut sections 414 having the first length 422, each extending from the tip 412 relative to a central longitudinal axis 426 of the cells. Thus, the total length of the tip region 402 may be twice the first length 422 (e.g., in a range of 1.6-2.8 mm, 1.8-2.4 mm, or 1.9-2.2 mm, or about 2.0 mm).

[0118] Further, in some examples, the narrow or tapered strut portions 414 of the inflow tip regions 404 may have a second length 424, wherein the second length 424 is less than the first length 422 ( Fig. 9C). In some examples, the second length 424 is in a range of 0.3-0.7 mm, 0.4-0.6 mm, or 0.45-0.55 mm. In some examples, the second length 424 is about 0.5 mm (e.g., ±0.03 mm). Each of the two narrow strut sections 414 of the same inflow tip region 404 may have the second length 424 (in Fig. 9C, only one is shown). Thus, the total length of the tip region 404 may be twice the second length 424 (e.g., in a range of 0.6-1.4 mm, 0.8-1.2 mm, or 0.9-1.1 mm, or about 1.0 mm).

[0119] Each exhaust strut 460 and inlet strut 462 may have a length that includes a tip region (402 or 404), the transition sections or regions 420, and the two angled strut portions 410 on either side of the tip region. Half of the total length of each exhaust strut 460 and inlet strut 462 is shown in the Fig. 9B and Fig. 9C as a length 425 extending from one end of an angled inflow section 410 to the central longitudinal axis 426. Thus, the length of each outflow strut 460 and inflow strut 462 is twice the length 425. In some examples, the length 425 for half of each inflow strut 462 may be different than the length 425 of half of each outflow strut 460.

[0120] The length of each narrow strut portion 414 may be at least 25% of the length 425 of the corresponding half of the exhaust strut 460 or inlet strut 462. In other words, the length of each exhaust tip portion 402 (a total length twice the first length 422) and each inlet tip portion 404 (a total length twice the second length 424) may be at least 25% of the total length (twice the length 425) of the exhaust strut 460 or inlet strut 462. In some examples, the length of each tip portion (such as the exhaust tip portion 402) may be more than 25% of the total length of the corresponding exhaust strut 460 or inlet strut (twice the length 425), e.g., 25-35%.

[0121] In some examples, each outflow tip region 402 and inflow tip region 404 may include a curved, axially facing outer surface 428 and an arcuate or curved, axially facing inner recess 430 that forms the narrower strut portions 414. For example, the curved inner recess 430 may descend from an inner surface of the angled strut members 410 toward the curved outer surface 428, thereby forming the narrower strut portions 414. Thus, the curved inner recesses 430 may be formed on a cell side of the tip region (e.g., as opposed to the outer side of the tip region).

[0122] In some examples, the curved outer surface 428 of each tip region (402 or 404) may form a single, continuous curve from one angled strut portion 410 on a first side of the tip region to another angled strut portion 410 on an opposite, second side of the tip region. In contrast, the tips of the frames of the Fig. 1 and 3, respectively, have three or four curves (e.g., tip 220 has four bends or curves from an angled strut on one side of the tip to another angled strut on an opposite side of the tip).

[0123] 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 an entirety or an 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 previous tip designs with more pointed or U-shapes. In some examples, the radius of curvature 432 may be greater than 1 mm. In some examples, the radius of curvature 432 may be in a range of 1-20 mm, 3-16 mm, or 8-14 mm. In some examples, the radius of curvature 432 may be greater than 10 mm. In some examples, the radius of curvature 432 may be approximately 13.5 mm (±0.03 mm). The radius of curvature 432 may be dependent on the width 416 (e.g.,the extent of the reduction in width compared to the angled strut sections 410) and the length (422 or 424) of the narrow strut sections 414 (and thus change due to changes).

[0124] In some examples, the radius of curvature 432 may be defined such that the tip region (inflow tip region 404 or outflow tip region 402) is flat (e.g., the radius of curvature 432 may be infinite). In such cases, the outer surface 428 may, for example, be planar, with the planar outer surface 428 defined normal to the central longitudinal axis 426.

[0125] Further, a height (an axial height) 464 of the outflow tip portions 402 and the inflow tip portions 404, which may be defined in the axial direction from an outer surface of the two angled strut parts 410 to the curved outer surface 428 of the tip portion at the tip 412, may be the width 416 of the narrow strut parts 414 (as in Fig. 9B). In this way, the height 464 of the outflow tip regions 402 and the inflow tip regions 404 can be relatively small and do not contribute much to the overall axial height of the radially expandable frame 400. Thus, as described above, valve leaflets attached to the frame 400 can be located near the inflow end 408, leaving a larger open area at the outflow end 406 of the frame 400 that is not blocked by the valve leaflets.

[0126] A remainder of the frame 400 can be similar to the frame 300 of the Fig. 5 and Fig. 6. In some examples, each of the outflow tip regions 402 and the inflow tip regions 404 may form an angle 440 between the two angled strut sections 410 extending from either side of the corresponding tip region ( Fig. 9A). In some examples, angle 440 may be similar to angle 320 of frame 300. In some cases, angle 440 may, for example, be in a range of 120 (not including) to 140 degrees (e.g., such that angle 440 is greater than 120 degrees and less than or equal to 140 degrees). In some examples, angle 440 may be in a range of 135-140 degrees, 138-140 degrees, or 139-140 degrees. In some examples, angle 440 may be approximately 140 degrees (e.g., ±1 degree).

[0127] The point of maximum stress (during the extension of the frame 400) of the frame 400 with the above-described outflow tip regions 402 and inflow tip regions 404 may occur in the outflow tip regions 402, as indicated by the dashed circle 434 in Fig. 9A. In some examples, the maximum stress at point 434 may be 1,795 MPa. This is less than the maximum stress of frame 300 ( Fig. 6), but it may still be desirable to have a frame with a lower maximum voltage that does not occur in the peak regions of the frame.

[0128] Fig. 10A-10C show another example of an end section of a frame 500 having tip regions 502 at both an upstream end section 508 and an downstream end section 506 of the frame 500. The tip regions 502 may be the same or similar to the downstream tip regions 402 of the frame 400. For example, each tip region 502 (at the upstream end and the downstream end) may include the tip 412 and two narrow strut sections 414, with one narrow strut section 414 extending from each side of the tip 412 to a corresponding wider, angled strut section 410. Further, each tip region 502 at the inlet end 508 and outlet end 506 of the frame 500, similar to the tip regions 402 of the frame 400, may have the width 416 and narrow strut portions having a first length 422.

[0129] Further, each tip region 502 and two corresponding angled strut sections 410 at the outflow end 506 may form an outflow strut 560, and each tip region 502 and two corresponding angled strut sections 410 at the inflow end 508 may form an inflow strut 562.

[0130] Similar to frame 400, the first length 422 of the narrow strut portion 414 may cause the overall length of the tip region 502 to be at least 25% of the overall length (twice the length 425 shown in the Fig. ) of the corresponding outflow strut 560 or inflow strut 562. In some examples, the length of each tip portion 502 may be more than 25% of the total length (twice the length 425) of the outflow strut 560 or the inflow strut 562, for example, 25-35% ( Fig. 10B and Fig. 10C).

[0131] Thus, in frame 500, both the tip regions 502 at the inflow end 508 and the outflow end 506 may include the longer, narrower strut sections 414 with the first length 422. This configuration of the tip regions 502 may result in a reduced maximum stress at a location spaced from the tip regions 502. For example, the point of maximum stress (during expansion of frame 500) of frame 500 may occur in a region of the angled strut sections 410 near a strut connection 510 and away from the tip region 502, as indicated by the dashed circle 512 in Fig. 10A. In some examples, the maximum stress at point 512 may be 1.619 MPa.

[0132] In some examples, the tip portions 502 of the frame 500 may be further defined by the angle 440 and the radius of curvature 432 ( Fig. 10A) as defined above with reference to the Fig. 9A-9C.

[0133] In some examples, the frame 500 may include axially extending window strut portions 514 that define commissure windows 520 of the frame 500 ( Fig. 10A). The window strut sections 514 may form an upper (or outflow) end section 516 above the commissure window 520 and a lower (or inflow) end section 518 below the commissure window 520, with the upper end section 516 being larger (or longer, in the axial direction) than the lower end section 518. This configuration may offset the commissure window 520 slightly toward the inflow end 508 of the frame 500 (similar to that discussed above with respect to the window strut sections 370a and 370b in Fig. 8).

[0134] In other examples, such as the partial view of the frame in Fig. 11, the frame 500 may include axially extending window strut portions 522 that define the commissure windows 520 of the frame 500. The window strut portions 522 may form an upper (outflow) end portion 524 above the commissure window 520 and a lower (inflow) end portion 526 below the commissure window 520, wherein a length 528 (in the axial direction) of the upper end portion 524 is equal to or substantially equal to 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's strut portions (e.g., the angled strut portions 410). In some cases, the length 528 may, for example, be in a range of 0.35-0.5 mm or 0.38-0.45 mm, or about 0.4 mm (e.g., ±0.03 mm).

[0135] The reduction in maximum stress during radial expansion of frame 500 (compared to previously disclosed frames, including frames 300 and 400) away from tip regions 502 may be attributed to the stress stiffening of tip regions 502 that occurs during radial compression or crimping of frame 500 into its radially compressed configuration. As shown in Fig. 12, the frame 500 may, for example, be compressed or crimped into a radially compressed configuration 530 (e.g., for delivery at the distal end portion of a delivery device to a target implantation site) and then radially expanded (e.g., upon reaching the target implantation site for implantation) into its radially expandable configuration 532. Fig. 12 shows overlapping partial views of the frame 500 in its radially compressed configuration 530 and its radially expandable configuration 532 for comparison purposes.

[0136] For example, when the frame 500 is crimped into its radially compressed configuration 530, the tip regions 502, particularly around a more central region including the tip 412, bend and are plastically deformed. As a result, the tip regions 502 are work hardened (or strain stiffened). As shown in Fig. 12, the points of maximum crimping stress occur in the tip regions 502, as indicated by the dashed circle 534.

[0137] During the subsequent radial expansion into the radially expanded configuration 532, the tip regions 502, because they have been strain-hardened, are not plastically deformed during the expansion. Instead, the points of maximum stress during the expansion of the frame 500 may occur along the angled strut sections 410, away from the tip regions 502, as indicated by dashed circles 536 in Fig. 12. In this way, the bending points of the frame between crimping and expansion of the frame 500 are shifted from the tip regions 502 to points away from the tip regions 502 (points represented by circles 536). As a result, the tip regions 502 can be stronger and less susceptible to damage, and the frame 500 can be more robust.

[0138] As in Fig. 11 and Fig. 12, the frame 500 may also include horizontal struts 538 that extend between adjacent cells 535 of a row of cells of the frame 500. The horizontal struts 538 may extend in a circumferential direction and are also referred to as circumferentially extending struts 538. The horizontal struts 538 may connect angled struts of two adjacent rows of angled struts of the frame 500. For example, each horizontal strut 538 may be connected to two angled struts of a row of struts (e.g., the ones shown in Fig. 11) and two angled struts in another adjacent row of struts (e.g. the struts shown in Fig. 11). Consequently, an angled strut 539 extending between a commissure window 520 and the horizontal strut 538, and an angled strut 537 extending between the horizontal strut 538 and another horizontal strut 538 disposed adjacent the inflow end 508 of the frame may be aligned along an angled line that may follow a wave line of the valve leaflets (when the leaflets are attached to the frame 500). Thus, the horizontal struts 538 may allow the angled struts to follow a shape that more closely matches a wave line of the valve leaflets when the frame 500 is in the radially expandable configuration 532.In addition, the horizontal struts 538 may act as spacers that may maintain a gap 533 between the angled struts when the frame 500 is in the radially compressed configuration 530 (as shown in FIG. Fig. 12), thereby reducing the risk of pinching the valve leaflets between the struts in the radially compressed configuration 530.

[0139] Fig. 13 is a perspective view of an example of a prosthetic valve 600 including a frame 620 and an outer skirt 602 (made of fabric) attached to the frame 620. The frame 620 may include a plurality of interconnected and angled struts 630 and a plurality of tip portions 632 at an inflow end 622 and outflow end 624 of the frame 620. The frame 620 may be similar to (or substituted for) one of the frames described herein, such as one of the frames 300 ( Fig. 5-8), 400 ( Fig. 9A-9C) or 500 ( Fig. 10A-10C). As in Fig. 13, the outer skirt 602 may extend around an outer surface of the frame 620 from the inlet end 622 to the outlet end 624 (in Fig. 13 covered by the outer skirt 602). In some examples, as in Fig. 13, the outer skirt 602 may be secured to the struts of the frame at the inlet end 622 by one or more seams or seam threads 604.

[0140] Further, in some examples, an outflow end of the outer skirt 602 may be connected to inflow end portions 248 of the axial struts 232 and / or to upper or outflow ends of the angled struts 234 (see Fig. 5) by one or more seams 606. In some examples, a portion of the seams 606 may extend through and be secured to the openings 249 in the inflow end portions 248 of the axial struts 232 (the openings 249 are Fig. 13 by dashed lines to indicate their position below the outer skirt 602). In some examples, the seams 606 and / or the seams 604 may be in-and-out seams.

[0141] In some examples, such as Fig. 13, additional seams 608, which may be configured as whipstitches, may attach the outer skirt 602 to angled struts of the frame 620 that are disposed and extend between the inflow end 622 and the inflow ends of window strut portions that form the commissure windows of the frame 620.

[0142] As introduced above, exposed tips of a prosthetic valve frame may interact with an inflatable balloon of a delivery device to which the prosthetic valve is attached (radially compressed) and / or a delivery sheath through which the delivery device is advanced en route to a target implantation site. Therefore, exposed tips of the prosthetic valve frame may traumatize the delivery device, the delivery sheath, and / or the patient's vascular system. The tip regions (402, 404) of the frame 400 ( Fig. 9A-9C) and the tip portions 502 of the frame 500 may be more atraumatic than previously disclosed tips with more pointed tips or U-shapes due to their rounder crimped profile (which may be provided by the increased angle and shape of the tip portions as described above).

[0143] For example, when the frame 500 is in the radially compressed configuration 530, the tip regions 502 form a curved shape along their outer surface 428, as shown in Fig. 12. Such a shape may facilitate sliding over the inflatable balloon of the delivery device when sliding the prosthetic valve from an initial attachment position (e.g., off the balloon or partially off it) to a deployment position over the balloon (e.g., when the prosthetic valve is initially crimped off a major portion of the balloon). The continuously curved shape of the tip regions of the frame may also reduce the likelihood of the tip regions (e.g., at apex 412) becoming snagged into the balloon during delivery to the target implantation site (during initial mounting on the balloon, as in the exemplary delivery device of Fig. 2) and / or penetrate the feeder sheath.

[0144] In some examples, it may be desirable to provide an even more atraumatic surface at the tip regions (e.g., at least at the distal end of the frame, which may be the inflow end). In one example, the reduced-height, curved, and narrower tip regions (e.g., tip regions 402, 404, and / or 502) may be further rounded and / or deburred at their edges (e.g., the outer edge surrounding the Fig. 9B, Fig. 9C, Fig. 10B, Fig. 10C and Fig. 12 curved outer surface 428).

[0145] In another example, as in Fig. 14A and Fig. 14B, the Fig. 14A (or alternatively, tip regions 402 or 404) can be rotated or twisted about its axis 702 (which may be referred to as a transverse axis) in the direction of arrows 704 to form a twisted outer surface 706 ( Fig. 14B). Such a twisted outer surface 706 may be less blunt and more atraumatic to the delivery device components and / or the natural anatomy exposed to or in contact with the tip region 502.

[0146] In another example, at least a portion of one or more tip regions (e.g., tip regions 402, 404, and / or 502) of a frame (e.g., one of frames 400 or 500) may be covered by damping elements. For example, in some cases, as in Fig. 15, a cushioning element 802 may cover at least a portion of a tip region 502 at the inflow end portion 508 of the frame 500. In other examples, the frame 500 may be formed by the frame 400 ( Fig. 9A-9C), and the cushioning elements 802 may cover the inflow tip regions 404 and / or the outflow tip regions 402.

[0147] As in Fig. 15, the cushioning member 802 may be connected to and cover at least a portion (e.g., a distal end, such as the apex 412) of a tip region 502 at the inflow end 508 of the frame 500. In some examples, each tip region 502 at the inflow end 508 may be at least partially covered by a different cushioning member 802.

[0148] The cushioning member 802 may comprise a flexible material folded over the tip region 502 (e.g., a central portion of the tip region 502 including the tip 412). In some examples, the flexible material may be made of fabric. In other examples, the flexible material may be another type of relatively soft, flexible material such as woven fabric, a relatively soft, flexible polymer (e.g., silicone), or the like. If made of a fabric, the fibers of the fabric may be made of various biocompatible materials, e.g., polyethylene terephthalate (PET). The fabric may be a woven fabric, a nonwoven fabric, or a pile fabric (e.g., velvet, velour, etc.) having tufts or loops of fiber extending from a woven base layer. Each of the various fabrics described in U.S. Publication No.2019 / 0192296, which is incorporated herein by reference, may be used to form the cushioning element 802.

[0149] In some examples, the cushioning member 802 includes a plurality of pleats 804 disposed over and extending across the curved outer surface 428 of the tip portion 502, forming a distal surface (or layer) 806 of the cushioning member 802. In this way, the plurality of pleats 804 may be formed over and across the tip 412 of the tip portion 502. The plurality of pleats 804 may extend between an inner layer 808 and an outer layer 810 of the cushioning member 802, with the inner layer 808 covering a radially inwardly facing inner surface (e.g., toward a central longitudinal axis of the frame) of the corresponding tip portion 502 and the outer layer 810 covering a radially outwardly facing surface (e.g., away from a central longitudinal axis of the frame) of the corresponding tip portion 502.In this way, the inner layer 808 is arranged closer to the central longitudinal axis than the outer layer 810.

[0150] In some examples, the inner layer 808 and the outer layer 810 of the cushioning member 802 may extend along / across the entire width 416 of the tip region 502.

[0151] By covering at least the curved outer surface 428 of the tip portion 502 at the tip 412, the cushioning member 802 may further reduce abrasion between the exposed tip portions 502 and an inflatable balloon of a delivery device and / or an inner surface of a sheath during delivery of the heart valve prosthesis to the target implantation site, thereby reducing damage to the sheath and / or balloon.

[0152] It should be understood that references to the distal and proximal ends of the valve prosthesis and / or frame 500 may refer to the positions of the ends of the valve during the delivery device. For example, if a heart valve prosthesis comprising frame 500 (or frame 400) is to be delivered to the distal end portion of the delivery device (as shown in Fig. 2 and Fig. 4), the inflow end of the prosthetic valve is the distalmost end of the prosthetic valve and the outflow end of the prosthetic valve is the proximalmost end of the prosthetic valve. This arrangement may be suitable for retrograde delivery of the prosthetic valve through the aorta into the native aortic valve. However, in other examples, the outflow end of the prosthetic valve may also be the distal end of the prosthetic valve during delivery, depending on the particular delivery method and the particular implantation site in the heart. For example, if a prosthetic valve is delivered into the native mitral valve via a transseptal delivery route, the outflow end of the prosthetic valve may be the distalmost end of the prosthesis.Thus, the cushioning elements 802 (and / or other configured cushioning elements) may be mounted at the inflow end or the outflow end of the valve prosthesis, depending on the particular delivery pathway and the particular implantation site in the heart for the procedure.

[0153] Furthermore, in other examples, the damping elements 802 may be attached to both the inflow and outflow ends of the prosthetic valve. In still other examples, the damping elements 802 may be attached only to the tip regions 502 at the inflow end of the prosthetic valve.

[0154] In some examples, such as Fig. 15, each tip region 502 (e.g., at least at the upstream end or at the distal end of the frame during delivery) of the plurality of tip regions 502 includes a single cushioning element 802 covering at least the tip 412 of the tip region 502. In alternative examples, a single cushioning element may cover each individual tip region 502 of the plurality of tip regions 502 at the upstream end 508 of the frame 500. In these cases, the single cushioning element may, for example, comprise a single, circumferential sleeve disposed around the entire circumference of the upstream end 508 and covering the entire tip region 502 at the upstream end 508. In other examples, the frame 500 may include two or more cushioning elements, each covering at least two tip regions 502. In still other examples, the cushioning element or elements may be part of an outer skirt or an inner skirt of the valve.In these examples, the apron may have integrated individual damping elements or a single damping element.

[0155] Fig. 20-29 show additional examples of a cover and / or cushioning member for tip regions of a frame of a prosthetic valve. These covers and / or cushioning members may, for example, reduce friction between the tip regions and one or more components of a delivery device or delivery system, such as an introducer or introducer sheath, a delivery sheath, and / or a balloon of the delivery device, e.g., when the prosthetic valve is radially compressed around a portion of a distal end section of the delivery device and / or advanced relative to the delivery sheath (e.g., to expose the prosthetic valve at an implantation site). Further, in some examples, the delivery sheath through which the radially compressed prosthetic valve is advanced on the delivery device may be an expandable delivery sheath.Thus, during advancement through the expandable delivery sheath, the prosthetic valve may exert a radial force to expand the sheath (e.g., against the vessel wall), as well as an axial force component resulting from the contact of the frame (e.g., the upstream tips or tip regions of the frame) with the inner wall of the sheath during advancement (e.g., shear stress). This axial force component is proportional to the coefficient of friction between the tips (or tip regions) and the delivery sheath, and the stress is inversely proportional to the area (force divided by contact area). Reducing the coefficient of friction and increasing the contact area at the distal end (e.g., at the inflow end when using a transfemoral delivery sheath with a prosthetic valve) of the prosthetic valve may therefore be desirable to reduce the axial force component during valve advancement through the delivery sheath.

[0156] Fig. 20-24 show examples of wrapping one or more tip regions of a frame of a prosthetic valve with a material. These wraps may, for example, reduce friction, provide cushioning, and / or a non-abrasive covering of the tip regions. The wraps may be made of various materials, such as a polymeric or fabric material. For example, one or more tip regions (e.g., tip regions 402, 404, and / or 502) of a frame (e.g., one of frames 400 or 500) may be covered by a covering member that is looped or wrapped around a perimeter of the strut portions that form the tip region. In some examples, as in Fig. 20, a covering element 1100 (e.g., a seam or other polymeric or fabric strip or band of material) may cover and / or be wrapped around at least a portion of a tip region 502 at the inflow end section 508 of the frame 500.

[0157] It should be noted that the frame 500 in the Fig. 20-24 is used as an example and that in other examples, the cover member 1100 may cover a tip region or tip of any other frame described herein in a similar manner as described below with reference to the Fig. 20-24 described.

[0158] As introduced above, each tip region 502 may include a tip 412 and two narrow strut portions 414, with a narrow strut portion 414 extending from each side of the tip 412 to a corresponding, wider, angled strut portion 410 of the inflow strut 562 (or outflow strut 560). Further, each tip region 502 may have a curved, axially facing outer surface 428 and an inner recess 430 forming the narrower strut portions 414. In some examples, the curved outer surface 428 of each tip region 502 may form a single, continuous curve from one angled strut portion 410 on a first side of the tip region 502 to another angled strut portion 410 on an opposite, second side of the tip region 502.

[0159] Thus, each tip region 502 may include shoulders 540 (or shoulder portions) on both sides or ends of the tip region 502 that transition from the narrower, tapered strut portions 414 of the tip region 502 to the wider, angled strut portions 410 of the corresponding inflow end strut 562 or outflow end strut 560. The shoulders 540 may be disposed on / at an axially facing inner surface 542 of the inflow strut 562 or the outflow strut 560.

[0160] As in Fig. 20, the cover member 1100 may wrap around and cover at least a portion of the tip portion 502. In some examples, the cover member 1100 may wrap around and cover a portion or all of the narrow strut portions 414 between the shoulders 540 of the tip portion 502. In other examples, the cover member 1100 may wrap around and cover the tip portion 502 and a portion of one or more of the angled strut portions 410 connected to the tip portion 502 (e.g., as shown in Fig. 21-24 and described below).

[0161] In some examples, a cover member 1100 may wrap around and cover the tip portions 502 of one or more of the inflow struts 562 (e.g., in some cases, each inflow strut 562). In some examples, a cover member 1100 may wrap around and cover the tip portions 50 of one or more of the outflow struts 560.

[0162] The cover member 1100 may be configured as a strip or band of material that is looped (or wrapped) around the tip regions 502. The cover member 1100 may be wrapped around a perimeter of the narrow strut portions 414 of the tip region 502 such that a plurality of loops 1102 are formed side by side across the tip region 502 (e.g., relatively tight loops such that the loops 1102 touch the narrow strut portions 414 and do not hang from them). In some cases, adjacent loops may at least slightly overlap. In other cases, adjacent loops may abut one another (i.e., not overlap). In still other cases, adjacent loops may have a gap between them in which the tip region is slightly exposed.

[0163] The cover member 1100 may be made of a relatively smooth material such as polytetrafluoroethylene (PTFE). In some examples, the cover member 1100 may be a strip or monofilament comprising a material with higher strength and a relatively low coefficient of friction, such as ultra-high molecular weight polyethylene (UHMWPE) or polyetheretherketone (PEEK). Such materials may provide a larger radius of curvature, resulting in less abrasion of the delivery sheath as the radially compressed prosthetic valve is delivered from the delivery device through the delivery sheath to the implantation site.

[0164] As in Fig. 20, in some examples, the cover member 1100 may be coupled at one end to a shoulder 540 of a tip portion 502 (e.g., by knotting or tying the end of the cover member 1100 in a knot such as a "granny knot" or double knot) and then repeatedly looped around the narrow strut portions 414 of the tip portion 502 to the opposite shoulder 540 of the tip portion 502. In this manner, multiple loops 1102 of the cover member 1100 may be formed across the tip portion 502 between the two shoulders 540 of the tip portion 502.

[0165] In some examples, a remaining or free end portion of the strand of the cover member 1100 may extend beneath a last (or end) loop 1104 of the cover member 1100 to lock it in position around the tip region 502. From the last loop 1104, the free end portion of the strand of the cover member 1100 may then extend toward the nearest shoulder 540 of the adjacent tip region 502 ( Fig. 20), thereby forming a bridge portion 1106. The free end portion of the cover member 1100 can then loop or wrap around the adjacent tip region 502.

[0166] In some examples, this process may be repeated to extend a single strip or band comprising the cover member 1100 (or one or more interconnected strips or bands) around and between all of the tip regions 502 at the inflow end 508 (or outflow end 506) of the frame 500. As a result, all of the inflow tip regions 502 at the inflow end 508 (and / or outflow end 506) of the frame 500 may be covered by the cover member 1100. In this way, the cover member 1100 may include a plurality of loops 1102 covering each tip region 502 at the inflow end 508 (and / or outflow end) of the frame 500, and a plurality of bridge portions 1106 (or extension portions) between the loops 1102 of adjacent tip regions 502.The plurality of bridge sections 1106 may extend across the inflow end 508 of the frame, from one plurality of loops 1102 of one tip region 502 to another plurality of loops 1102 of an adjacent tip region. This may result in the cover member 1100 at the inflow end 508 forming a ring of cover material around the perimeter of the frame 500.

[0167] In some examples, such as Fig. 27, the cover member 1100 may also extend through an outer skirt disposed around an outer surface of the frame 500, thereby securing the outer skirt to the frame 500. For example, an exemplary outer skirt 1150 disposed around an outer surface of the frame 500 may be attached or sewn to the cover member 1100 at an inflow end of the frame ( Fig. 27). Fig. Figure 27 shows an interior view of a portion of the frame 500 with the outer skirt 1150 arranged around and secured to the frame (the outer skirt 1150 appears in Fig. 27 behind the frame 500, as it is an inside view). Fig. The outer skirt 1150 shown in Figure 27 may comprise any combination of the materials described herein with reference to an outer skirt of a prosthetic valve. Furthermore, in alternative examples, another outer skirt may be attached to the frame 500 or another frame of a prosthetic valve in a similar manner, as described below with reference to Figures Fig. 27 and 28A-29 (e.g., the outer skirt 1150 may be replaced by the outer skirt 602 of Fig. 13 or the outer apron of Fig. 1 and / or the frame 500 or 600 can be replaced by the frame 400 of Fig. 9A or the frame 300 of Fig. 5 be replaced).

[0168] As in Fig. 27, the cover member 1100 may extend around the tip regions 502 of the frame 500 (as described above) and through a material (e.g., fabric) of the outer skirt 1150 along an inflowing edge portion 1152 of the outer skirt 1150. In some cases, one or more or each of the loops 1102 of the cover member may be wrapped around the tip region 502 (as described above) and extend through the outer skirt 1150. From the last loop 1104, the cover member 1100 may then be sewn through the inflowing edge portion 1152 of the outer skirt 1150, forming a plurality of whipstitches 1154 through and around the inflowing edge portion 1152 between adjacent tip regions 502.

[0169] Fig. 28A-28C show an exemplary method for forming the loops 1102 and the whipstitches 1154 and for attaching the outer skirt 1150 to another exemplary frame 620 having the cover member 1100. Similar to the other frames described herein, the frame 620 may include tip portions 632 (632a and 632b in the Fig. 28A-28C) extending between angled struts 630. First, Fig. 28A: Starting at a first tip region 632a of the frame 620, the cover member 1100 may be extended through the leading edge portion 1152 of the outer skirt 1150 (e.g., using a needle) and looped around the first tip region 632a (e.g., adjacent a first shoulder of the first tip region 632a) to form a first loop 1103. In some cases, the cover member 1100 may be passed through the first loop 1103 to form a knot (e.g., a first knotted loop 1103). The cover member 1100 may then be wrapped around the first tip region 632a adjacent the first loop 1103 to form a plurality of loops 1102 (which, in some cases, may be whipstitches). In some examples, three loops 1102 may be formed. However, in alternative examples, the number of loops 1102 may be greater or less than three, e.g., two, four, or the like.

[0170] After forming the loops 1102, the final loop 1104 may be formed, in some examples, by sewing a locking stitch with the cover member 1100 ( Fig. 28B). In some examples, a locking stitch with the cover member 1100 may be formed around the first loop 1103, forming a first knot 1156, and then another locking stitch may be formed around the last loop 1104, forming a second knot 1158 ( Fig. 28B). However, in other examples, only one knot or no knot at all may be formed near the loops 1102.

[0171] Whip stitches 1154 extending from the first tip region 632a may then be formed around and through the leading edge portion 1152 of the outer skirt 1150 between the first tip region 632a and an adjacent second tip region 632b ( Fig. 28C). This process may then be repeated to form the loops 1102 over each tip region 632 and whipstitches 1154 along the leading edge portion 1152 of the outer skirt 1150 between adjacent tip regions 632.

[0172] The final configuration of the valve prosthesis, including the outer skirt 1150 attached to the frame 620 and the tip regions 632 covered by the cover member 1100, is shown in Fig. 29. It should be noted that although three loops 1102 of the cover member 1100 are shown extending through the outer skirt 1150 in Fig. 29, in alternative cases, fewer than three loops 1102 may extend through the outer skirt 1150 (e.g., two or only one). In such cases, for example, only a portion of the loops 1102 that wrap around the tip regions 632 may also extend through the outer skirt 1150. Further, the techniques described above for attaching the outer skirt to an upstream end of the frame using a cover member that wraps around the tip regions (or vertices) of the frame may be applied to a variety of different outer skirts and frames, such as any combination of the outer skirts and frames described herein.

[0173] By using the same component (cover member 1100) to both cover the tip regions of the frame and secure the outer skirt 1150 to the frame, the valve prosthesis can be assembled faster and easier. Furthermore, by using the same cover member 1100 (e.g., suture) to cover the inflow tip regions and to secure the outer skirt 1150 to the frame, a crimped profile of the valve prosthesis can be reduced (compared to using a first cover member or suture to cover the tip regions and a second member or suture to secure the outer skirt 1150 to the frame).Furthermore, by extending the cover member 1100 through the outer skirt 1150, the loops 1102 of the cover member 1100 can be more securely attached around the tip regions, preventing them from moving or sliding away from the tip regions during radial compression of the prosthetic valve. This allows the cover member 1100 to continue to cover the tip regions while the prosthetic valve is in the radially compressed configuration.

[0174] Fig. 21-24 show additional examples of cover elements for one or more tip regions 502 of the frame 500 (or any of the other tip regions or vertices of the frames described herein). As shown in the Fig. 21 and Fig. 22, a cover member 1200 may include a plurality of loops 1202 that wrap around one or more tip portions 502 at one end (e.g., the inflow end 508) of the frame 500. Although the Fig. 21 and Fig. 22 show that the loops 1202 of the cover element 1200 cover the entire inflow strut 562, in other examples the loops 1202 may only cover the tip regions 502 (between the shoulders 540), as in Fig. 20. Furthermore, in some examples, the cover element 1200 may include bridge sections that Fig. 20 are the same or similar to the bridge sections 1106 shown.

[0175] In some examples, such as Fig. 21 and Fig. 22, the cover member 1200 may include nodes 1204 formed between the loops 1202 covering adjacent inflow struts 562 (and / or outflow struts 560), with the nodes formed around strut connections 510 between the adjacent inflow struts 562.

[0176] In alternative examples, the nodes 1204 may be replaced by forming longitudinal slots or recesses in the strip or strand of the cover element 1200 and inserting the cover element 1200 at the position of the nodes 1204 in Fig. 21 and Fig. 22 is threaded through itself. Fig. 23 and Fig. 24, for example, show such a case where a cover member 1300 includes a plurality of loops 1302 that wrap around the tip regions 502 at one end (e.g., the inflow end 508) of the frame 500 and a plurality of connecting portions 1304 that extend between adjacent inflow struts 562 via a strut connection 510 between the adjacent inflow struts 562.

[0177] As described above with reference to the cover member 1100 of Fig. 20, the cover element 1200 can be Fig. 21 and Fig. 22 and / or the cover element 1300 of Fig. 23 and Fig. 24 may comprise a strip, strand, or suture comprising a material with a relatively low coefficient of friction, such as PTFE, UHMWPE, or PEEK, thereby promoting smooth sliding of the inflow end of the prosthetic valve 508 over and through the inner wall of the delivery sheath. For example, the coefficient of friction between the cover member 1100 and the delivery sheath should be lower than the coefficient of friction between a bare metal of the prosthetic heart valve frame and the delivery sheath.

[0178] In some examples, the cover elements described herein may have a static coefficient of friction in a range of 0.04-0.4, 0.04-0.2, or less than 0.2 with respect to the inner wall of the feed sleeve. In some examples, the cover elements described herein may have a dynamic coefficient of friction in a range of 0.04-0.2 or 0.04-0.1, or less than 0.1 with respect to the inner wall of the feed sleeve.

[0179] The width of the strip, band, or suture comprising the cover member 1100, 1200, and / or 1300 may be selected to increase the contact area of ​​the tip regions 502 (e.g., at the inflow end 508) with the inner wall of the delivery sheath, thereby reducing the shear stress to a value below the yield strength of the sheath, which is determined by the force (e.g., the axial force component) divided by the total contact area. This may, for example, reduce the likelihood of the valve sticking to the delivery device (e.g., the sheath).

[0180] For example, the Fig. 21 and Fig. 22 the cover element 1200 comprising a strip, a band or a suture thread with a first width 1206, and the Fig. 23 and Fig. 24 show the cover element 1300 comprising a strip, band, or seam having a second width 1306 that is greater than the first width 1206.

[0181] In addition to reducing the shear stress of the tip regions 502 against the delivery sheath during guidance of the prosthetic valve through the delivery sheath to the implantation site, the proposed cover elements can, for example, improve the alignment between the prosthetic valve and the balloon on the delivery device.

[0182] For example, during external balloon crimping (e.g., radially compressing the prosthetic valve around the delivery device outside the inflatable balloon), the prosthetic valve may be positioned in a radially compressed configuration proximal to the deflated balloon, which may have a series of pleats arranged around its circumference.

[0183] In practice, the balloon folds are not necessarily folded in a neat or organized manner. As the radially compressed prosthetic valve is advanced toward and over the balloon upon reaching the implantation site, some balloon folds may become caught on the strut connections (e.g., strut connections 510) at the inflow end of the frame, preventing further advancement of the prosthetic valve over the balloon. In some cases, this may even result in balloon damage.

[0184] The bridge sections 1106 of the cover element 1100 ( Fig. 20) can prevent such a blockage of the prosthetic valve advancement over the balloon from occurring. For example, the bridge sections 1106 can act as a barrier to the balloon folds, thereby preventing the balloon folds from catching on the strut joints 510 at the inflow end. More specifically, as the prosthetic valve is advanced over the balloon, the bridge sections 1106 can contact the balloon folds and deflect these folds radially inward relative to the strut joints 510, allowing the valve to slide over the balloon in a relatively smooth manner.

[0185] Additionally, the smoother material of the cover member 1100 at the leading edge (e.g., at the inflow end) of the prosthetic valve may further facilitate correct alignment of the prosthetic valve over the balloon and / or lower resistance.

[0186] Instead of or in addition to the cover element, the tip regions or tips of the frame (e.g., the tip regions at the inflow end of the frame) can be dip-coated or overmolded with a polymer, forming a circular cover over and / or around the tip regions or tips. Since polymeric materials are softer and more flexible than most metals, such dip-coated or overmolded covers cannot interfere with the radial compression or expansion of the frame.

[0187] Fig. 25 and Fig. 26 show another example of a cover element for tip regions or tip regions of a frame 1400 of a valve prosthesis. More specifically, the Fig. 25 and Fig. 26 shows an example in which the cover element is configured as a flap of a skirt 1410 (or a perivalvular sealing element) of the heart valve prosthesis to envelop and cover a corresponding tip or tip region 1402 of the frame 1400. The frame 1400 may include a plurality of interconnected and angled struts 1406 and a plurality of tip regions 1402 at an inflow (or first) end 1404 of the frame 1400. The frame 1400 may be one of the frames described herein, such as one of the frames 300 of Fig. 5, frame 400 of Fig. 9A-9C or frame 500 of Fig. 10A-10C.

[0188] In some examples, a skirt 1410 (e.g., a fabric skirt) may be disposed around a surface of the frame 1400 and may include tabs 1412 extending distally from a first edge 1414 of the skirt 1410. As shown in the Fig. 25 and Fig. 26, the first edge 1414 of the skirt 1410 may be an inflow edge attached to the inflow end 1404 of the frame 1400. The tabs 1412 of the skirt 1410 may be spaced apart from each other around a perimeter of the skirt 1410.

[0189] In some examples, the skirt 1410 may be an annular skirt. In some examples, the skirt 1410 may be comprised of one or more skirt sections that are connected to each other and / or individually to the frame 1400. The skirt 1410 may be comprised of a fabric or a polymeric material, such as ePTFE, PTFE, PET, TPU, UHMWPE, PEEK, PE, etc.

[0190] In some examples, the skirt 1410 may include a plurality of tabs 1412, which may include one tab 1412 for each tip region 1402 of the inflow end 1404 of the frame 1400.

[0191] Each tab 1412 may be configured to cover a corresponding tip region 1402. For example, each tab 1412 may have a width 1416 selected to cover at least a portion, or in some cases, all, of the tip region 1402. However, in some examples, the width 1416 may be selected to not cover an entire inflow strut 562 to which the tip region 1402 belongs.

[0192] Further, the plurality of tabs 1412 may extend from the first edge 1414 of the skirt 1410 and be arranged along the first edge 1414 such that each flap 1412 is aligned with a corresponding tip portion 1402 when the skirt 1410 is attached to the struts of the frame 1400 (as shown in Fig. 25). As a result, each flap 1412 can be folded over the corresponding tip region 1402 and the inflow end 1404 of the frame 1400 and secured thereto by one or more sutures 1408 (or other fastening means, ultrasonic welding, and / or other means of securing), thereby covering the tip region 1402 in a manner that conceals the tip region 1402 and protects the inner wall of the delivery sheath from being contacted by the tip regions 1402 during guidance of the prosthetic heart valve through the delivery sheath to the implantation site.

[0193] In some examples, such as the Fig. 25 and Fig. 26, the skirt 1410 may be an inner skirt disposed around an inner surface 1420 (radially inwardly directed relative to a central longitudinal axis of the frame 1400) of the frame 1400. As such, the tabs 1412 may wrap from the inner surface 1420 below the respective tip regions 1402 (at the inflow end 1404) and around an outer surface 1422 of the frame 1400 ( Fig. 26). The engravings 1418 (one in Fig. 26) may extend around the tip region 1402, through a first portion 1424 of the tab 1412 disposed over the inner surface 1420 of the tip region 1402, and around and / or through a second portion 1426 of the tab 1412 disposed over the outer surface 1422 of the tip region 1402 ( Fig. 26). In Fig. For example, in Figure 26, the stitch 1418 is shown as extending around the second portion 1426 of the flap 1412. However, in alternative examples, the seam 1418 may additionally or alternately extend through the second portion 1426 of the flap 1412.

[0194] In other examples, the skirt 1410 may be an outer skirt disposed around the outer surface 1422 of the frame 1400. Thus, the tabs 1412 may wrap from the outer surface 1422 below the respective tip regions 1402 (at the inflow end 1404) and around the inner surface 1420 of the frame 1400.

[0195] While the apron was introduced in 1410 Fig. 25 and Fig. 26 as covering the narrower tip regions 1402 of the frame 1400, in other examples, the tabs 1412 of the skirt 1410 may be configured to wrap around and cover any type of inflow tip region or tip region of a frame of a prosthetic valve (e.g., a more square or pointed tip, such as the tip 220 of the frame 200 in Fig. 3).

[0196] It should be noted that Fig. 26 is schematic for illustrative purposes and therefore small gaps are shown between the components (e.g., the frame 1400 and the skirt 1410 and / or the skirt 1410 and the tip portion 1402) to more easily distinguish the various components. However, in some examples, these gaps may be smaller than shown, or there may be few or no gaps between certain components (e.g., between the seam 1418 and the flap 1412). While in Fig. 26 the tabs 1412 are shown with rather square corners (due to the wrap), in some examples the tab 1412 may have a more rounded and flexible wrap shape (e.g., due to the fact that it is made of a fabric or polymer material).

[0197] A skirt comprising tabs configured to cover tips or tip regions at an end of the frame of a prosthetic valve (e.g., a leading end of the tab during advancement of the radially compressed prosthetic valve through the delivery sheath to an implantation site, which in some examples may be the inflow end) may prevent the tips or tip regions from penetrating and / or damaging the inner wall of the delivery sheath, as well as reduce the pushing force required to advance the prosthetic valve through the delivery sheath with the delivery device.

[0198] Further details and examples of cushioning or covering elements configured to cover at least a portion of one or more tips of a frame of a prosthetic valve can be found in International Patent Application No. PCT / US2020 / 044994, filed on August 5, 2020, which claims the benefit of U.S. Provisional Application No. 62 / 886,677, filed on August 14, 2019.

[0199] As described above, a frame for a prosthetic heart valve comprising tip regions with a reduced width extending over a length of at least 25% of a length of the inflow or outflow strut that includes the tip region can reduce the maximum stresses experienced by the frame during frame expansion and shift the maximum stresses away from the tip regions, thereby increasing the robustness and durability of the frame. Furthermore, tip regions with a single, continuous curve that curves between corresponding angled strut sections of the inflow or outflow strut and that forms an angle of between 120 degrees and 140 degrees between the two angled strut sections can result in a tip region with a minimal axial height (e.g.,, which is equal to the width of the tip region), which makes it possible to position leaflet margin sections of valve leaflets of the prosthetic heart valve closer to the inflow end of the frame and to increase an axial height of a first row of cells arranged at the outflow end of the frame, thereby providing more open area at the outflow end of the frame (not blocked by the commissures and outflow edges of the valve leaflets) for increased blood flow and coronary access. Furthermore, frames with tip regions defining this larger angle (e.g., greater than 120 degrees and up to 140 degrees) may exhibit less radial recoil upon deflation of the delivery device balloon following radial expansion of the prosthetic heart valve.Furthermore, such tip regions may be more atraumatic and interact less with the delivery device balloon and / or a delivery sheath when the valve prosthesis is attached to the delivery device and guided to a target implantation site.

[0200] In another example, the strain concentrations and / or maximum stresses observed at the tips of frames with reduced tip heights or tip regions with narrower regions (as in Fig. 5 and Fig. 6) can be reduced by creating a bump or protrusion in a central portion (or center) of the tip. As described below, this bump can, for example, reinforce the tip center and distribute stresses between the thinner regions of the tip on either side of the bump, thereby reducing the likelihood of material deterioration due to high stresses encountered at the tip during bending during frame expansion.

[0201] Fig. 16A and Fig. 16B show an exemplary example of a part of a frame 900 for a heart valve prosthesis, wherein the frame 900 corresponds to the frame 300 of the Fig. 5 and Fig. 6, except for the configuration of the tips. For example, the frame 900 may include interconnected struts 302 having tips (or tip portions) 902 at an inflow end and an outflow end 904 (shown in Fig. 16A and Fig. 16B) of the frame 900. Similar to the frame 300 of the Fig. 5 and Fig. 6, each tip 902 is between two angled struts 310 at the inflow or outflow end 904 ( Fig. 16A and Fig. 16B) of the frame 900 and forms a transition between them. A detailed view of a single tip 902 is shown in Fig. 16B.

[0202] Each tip 902 may have a curved or relatively flat outer surface 906 (axially toward the outflow end 904) and an arcuate or curved inner surface 914 disposed opposite the outer surface 906 (axially toward the inflow end). In contrast to the single inner recess of the tips 304 of the Fig. 5 and Fig. 6 comprises the inner surface 914 ( Fig. 16A) each tip 902 has two curved inner recesses, including a first inner recess 908 and a second inner recess 910 defined by a protuberance 912 ( Fig. 16B) are separated from each other. Thus, the inner surface 914 of the strut at the tip 902 has a generally "M" shape.

[0203] As in Fig. 16B, the bump 912 may protrude axially from the first inner recess 908 and the second inner recess 910. Further, the bump 912 may be located in a central region or in the middle of the tip 902, as shown in Fig. 16B by the central longitudinal axis 916. For example, the tips of the tip 902 and the tips of the bump 912 (extending in opposite axial directions) may be aligned along the central longitudinal axis 916.

[0204] The first inner recess 908 and the second inner recess 910 may create narrow regions of the tip 902 (on either side of the bump 912) that have a width (or height) 920 that is less than a width 318 of the angled struts 310 ( Fig. 16B). In some examples, the width 920 may be the same as or similar to the width 316 of the inner recess 314 of the tip 304 of the frame 300 ( Fig. 6). However, a portion of the tip 902 at the bump 912 may have a width 922 that is greater than the width 920 of the first inner recess 908 and the second inner recess 910 ( Fig. 16B). In some examples, the width 922 is even smaller than the width 318 of the angled struts 310.

[0205] In some examples, the difference between width 922 and width 920, which may be referred to as the height of bump 912, may be in the order of micrometers and thus not visible to the naked eye. Fig. 16B is slightly exaggerated for illustrative purposes (and may actually be smaller than it appears in Fig. 16B appears).

[0206] In some examples, the first inner recess 908 and the second inner recess 910, as well as the bump 912, may be formed using a laser. In some examples, the bump 912 may be within the dimensional tolerance of the strut (±0.025 mm) and may be formed by increasing the resolution of the laser beam in the tip regions (e.g., tip 902) where the bump 912 is formed. In addition to the regular tolerance of ±0.025 mm, a local tolerance is provided that relates to the width difference between the width 922 and the width 920 and thus locally follows the intersection curve. This tolerance may in some cases be approximately one order of magnitude smaller than the regular tolerance (e.g., 0.0025 mm, or in other cases, 1-10 µm). Thus, in some examples, the difference in width between width 922 and width 920 and thus the height of bump 912 can be 25 µm ± 2.5 µm.In some examples, the height of the bump 912 may be in a range of 10 to 50 µm or 20 to 30 µm.

[0207] Since the struts of frame 900, in some examples, may have a substantially rectangular cross-sectional shape for which the moment of inertia is I=(1 / 12)bh3 (where "h" refers to a height in the axial direction, which may be identical to the aforementioned width, and "b" refers to a thickness in the radial direction), the stress developed upon bending of tip 902 is proportional to the bending moment divided by the moment of inertia. Thus, a small increase in the height (or width) of the strut significantly influences (by a third power) the stress / strain developed at tip 902 (or in other areas of the struts).

[0208] Thus, the shape of the bump 912, which results in an increased width 922 (or height) at the center of the tip 902, reduces the strains developed in the central region of the tip 902, while distributing the maximum strains between the two adjacent narrow regions of the tip 902 on either side of the bump 912 (at the first inner recess 908 and the second inner recess 910). This, in turn, can significantly reduce the strains at the reduced-height tip 902, allowing the tip 902 to withstand bending forces (e.g., during radial expansion of the frame 900) without material damage.

[0209] As discussed above, in some examples, a prosthetic heart valve frame may include axial struts (e.g., axial struts 232) that have a greater width relative to the widths of the frame's angled struts (including the angled struts to which the axial strut is connected and extends between them). This provides a larger contact area when the prosthetic heart valve leaflets contact the wider axial struts during systole, thereby distributing stress and reducing the extent to which the leaflets can bulge radially outward through the cells of the frame beyond the axial struts. In this way, for example, the long-term durability of the prosthetic heart valve leaflets may be increased.

[0210] Widened axial struts can sometimes cause problems with coronary access after a valve-in-valve procedure. For example, in some situations, a second prosthetic heart valve may be inserted into a previously implanted first prosthetic heart valve. After such a valve-in-valve procedure, the axial struts of the first and second prosthetic heart valves may be in close proximity (e.g., side by side) to each other. If coronary access with a coronary access catheter is required and access is blocked by the adjacent axial struts of the first and second prosthetic heart valves, a balloon catheter can usually be advanced between the adjacent axial struts of the first and second prosthetic heart valves and inflated to expand or bend the axial struts laterally out of the way, creating a larger opening for coronary access.However, the widened axial struts disclosed here may result in increased resistance to the inflated balloon, and in some cases, the adjacent axial struts may not be able to be separated for coronary access.

[0211] To improve coronary access, a heart valve prosthesis with wider axial struts may also include a plurality of lateral slots or recesses (or notches) in the axial struts along an axial length of the axial struts. An exemplary widened axial strut 1000 with a lateral width 1022 and one or more slots or recesses 1002 is shown in Fig. 17. In some examples, as in Fig. 17, the one or more slots 1002 comprise a plurality of slots 1002. As described above, in some examples, the width 1022 of the axial strut 1000 may be in a range of 0.45 mm - 1.0 mm, 0.5 mm - 0.75 mm, or at least 0.6 mm.

[0212] The axial strut 1000 may be connected to and extend between the angled struts 1004 of the prosthetic heart valve. An axial length 1006 of the axial strut 1000 may be defined between a point where the lower ends of two angled struts 1004 converge and a point where the upper ends of two other angled struts 1004 converge. The slots or recesses 1002 may be spaced apart along the axial length 1006 of the axial strut 1000.

[0213] In some examples, the slots or recesses 1002 may be grouped into groups (e.g., pairs) 1016 of slots 1002 that are spaced apart from each other along the axial length 1006, with smaller distances (in an axial direction) between the slots 1002 included in a same group, thereby creating one or more solid or slot-free sections 1008 in the axial strut 1000 (e.g., sections that do not include slots 1002). In other words, each group 1016 may be spaced from an adjacent group 1016 along the length 1006 of the axial strut 1000 by an amount or distance that is greater than a distance between slots or recesses 1002 within the same group 1016.

[0214] In other examples, the plurality of slots or recesses 1002 of the axial strut 1000 may be evenly spaced from one another along the axial length 1006.

[0215] In some examples, the axial distance between the slots or recesses 1002 may vary within the same group 1016 (e.g., it may be smaller or larger than in Fig. 17 shown).

[0216] In some examples, the axial strut 1000 may include a first lateral edge 1010, a second lateral edge 1012, and a radially inwardly facing surface 1014 extending between the first lateral edge 1010 and the second lateral edge 1012. Each slot or recess 1002 may extend in a lateral direction from one of the first lateral edge 1010 and the second lateral edge 1012 in a lateral (or circumferential) direction 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 slot 1002 may extend through a portion of the width 1022 of the axial strut 1000 (e.g., only through the portion and not through the entire width 1022).

[0217] For example, a first section of slots or recesses 1002 (e.g., one for each pair or group 1016) may extend into the axial strut 1000 from the first lateral edge 1010 toward the second lateral edge 1012, with a closed end 1018 of the slot 1002 spaced from the second lateral edge 1012 by a (lateral) distance 1020. Likewise, a second section of slots or recesses 1002 (e.g., one for each pair or group 1016) may extend into the axial strut 1000 from the second lateral edge 1012 toward the first lateral edge 1010, with the closed end 1018 of the slot 1002 spaced from the second lateral edge 1012 by the (lateral) distance 1020. In some examples, the pitch 1020 may be in a range of 0.1 - 0.3 mm and the width 1022 may be in a range of 0.5 - 1.0 mm.

[0218] In some examples, the pitch 1020, and thus a width (in the lateral direction) of each slot or recess 1002, may vary for slots in the same axial strut 1000 and / or for different axial struts. The width of a slot or recess 1002 may be the difference between the width 1022 of the axial strut 1000 and the pitch 1020. For example, in one case, a first slot 1002 may have a first width and a second slot 1002 of the same axial strut 1000 may have a second width, where the second width is smaller than the first width (and thus the pitch 1020 for the second slot would be larger than for the first slot). In other examples, the width of each slot 1002 in the axial strut 1000 may be the same (and thus the pitch 1020 would be the same for each slot 1002).

[0219] Each slot 1002 may have an axial height 1024 in a range of 0.075 - 0.3 mm. In some examples, all slots or recesses 1002 in the axial strut 1000 may have the same height 1024. In other examples, one or more slots 1002 of the plurality of slots in the axial strut 1000 may have a different height (smaller or larger) than other slots 1002 of the plurality of slots in the axial strut 1000.

[0220] In some examples, the slots or recesses 1002 in the axial strut 1000 are formed by a laser (e.g., by laser cutting).

[0221] The slots 1002 may be referred to as release slots or release recesses and may be configured to increase compliance (e.g., flexibility) of the axial strut 1000, such that when a balloon of a balloon catheter inserted between adjacent axial struts of two (concentrically implanted) valve prostheses is inflated between the adjacent axial struts, the adjacent axial struts bend laterally outward and away from each other, thereby creating a region therebetween for coronary access. As shown in Fig. 18, for example, during a valve-in-valve procedure, a second (guest) prosthetic heart valve 1030 may be deployed, radially expanded, and implanted into an originally implanted first (host) prosthetic heart valve 1032. A first axial strut 1034 of the first prosthetic valve 1032 may be disposed proximally and adjacent to a second axial strut 1036 of the second prosthetic valve 1030 (where both the first axial strut 1034 and the second axial strut 1036 are identical to the axial strut 1000).

[0222] When the first axial strut 1034 and the second axial strut 1036 block coronary access (e.g., due to their positioning in front of an opening to a coronary artery and their close proximity to each other), a balloon catheter can be positioned between the first axial strut 1034 and the second axial strut 1036, and then a balloon 1038 of the balloon catheter can be inflated. When the balloon 1038 is inflated and applies pressure to the side edges of the first axial strut 1034 and the second axial strut 1036, the first axial strut 1034 and the second axial strut 1036 are bent outward in opposite directions due to their slots or recesses 1002. Thus, the first axial strut 1034 and the second axial strut 1036 are bent (or buckled) away from each other, creating a coronary access area between the first axial strut 1034 and the second axial strut 1036.

[0223] Through the slots or recesses 1002 extending from both lateral edges (sides) of the axial strut 1000, the axial strut 1000 can bend in one of two directions (laterally or circumferentially), depending on which side of the axial strut 1000 the balloon is positioned. As shown in Fig. 18, for example, the first axial strut 1034 bends in a first direction 1040 and the second axial strut 1036 bends in an opposite, second direction 1042.

[0224] The axial struts of each of the valve prostheses described here may be the same as or similar to the axial struts 1000 of the Fig. 17 and Fig. 18. As described in Fig. 19, for example, the axial strut 232 of the frame 500 ( Fig. 10A-12) may include the plurality of slots or recesses 1002. In some examples, as in Fig. 19, a first group of slots 1044 may be disposed in the wider outflow end portion 246 of the axial strut 232, a second group of slots 1048 may be disposed in the narrower middle portion 247 of the axial strut 232, and a third group of slots 1050 may be disposed in the wider inflow end portion 248 of the axial strut 232.

[0225] In some examples, such as Fig. 19, a width (in the lateral direction) of the slots or recesses 1002 in the first group of slots or recesses 1044 and the third group of slots or recesses 1050 may be greater than a width of the slots 1002 in the second group of slots 1048. As a result, the distance (e.g., the distance shown in Fig. 17) between the closed end of the slot 1002 and the side edge of the axial strut may be the same or similar for all slots 1002. In other examples, a width of the slots 1002 may be the same for all groups 1044, 1048, and 1050.

[0226] In other examples, all of the slots or recesses 1002 in the axial strut 232 may be located in the central section 247, with no slots in the wider outflow and inflow end sections 246, 248.

[0227] Although the examples in Fig. 17-19 show six slots or recesses 1002 in each axial strut, in other examples, each axial strut may include more or fewer than six slots 1002 (e.g., four, five, eight, or the like). In some examples, each axial strut may have only one slot 1002.

[0228] However, in some examples, three groups of two slots or recesses 1002 (a total of six slots 1002, as in the examples of Fig. 17-19), in which the two slots of the same group extend in opposite lateral directions, may be advantageous. Such a configuration provides, for example, three bending points in each direction (transverse direction), allowing the axial strut 1000 to be bent in one of two transverse directions (e.g., depending on which side of the axial strut receives a transverse force from an inflating balloon).

[0229] Furthermore, in some examples, the slots or recesses 1002 may have shapes other than those shown in the Fig. 17-19, such as triangular, square, conical, or similar (as opposed to oblong or rectangular with a curved closed end). Further, as mentioned above, the width and height of the slots 1002 may vary.

[0230] As introduced above, frames may have axial struts that are wider than the frame's angled struts to which they are connected. The axial struts may include axial struts without commissure windows (e.g., axial struts 232) and axially extending struts (with axially extending window strut portions, such as axially extending window strut portions 240) that define commissure windows therein. Regions of higher stress may be formed at the transition between the narrower angled struts and the wider axial struts (or axially extending window strut portions). In particular, the regions of higher stress may occur at a root or base of an angled strut at the outflow end of the frame, where the root of the angled strut curves outward (convexly) toward a greater width of the axial strut.These higher stress areas may be amplified at the axial struts with commissural window sections of the valve leaflets, as these struts are subjected to greater loads during operation of the prosthetic heart valve (e.g., because the valve leaflet commissure tabs are directly attached to the valve leaflets defined by the axial window sections of the axial struts). Therefore, it is desirable to reinforce the frame in these areas to increase the frame's durability.

[0231] As an example, the stresses occurring in these transition regions can be reduced, thereby strengthening the frame, by adding a concave region (or a depression that may result in a constricted region) to an end portion of the axially extending window strut sections and / or axial struts where they directly connect to a root or base of the angled struts of the frame. Examples of such concave regions applied to an exemplary frame 1600 for a heart valve prosthesis are shown in Fig. 30 and Fig. 31. Although in the Fig. 30 and Fig. 31 the frame 1600 is shown, which may be similar to the frame 400 or 500 described above, the steps described below with reference to the Fig. 30 and Fig. 31 can be applied to a variety of frames for heart valve prostheses, including all frames described here.

[0232] First of all Fig. 30: The frame 1600 may include a plurality of rows of angled struts 1602, including a first row of angled struts 1602a that form an outflow end 1604 of the frame 1600. The frame 1600 may include tip portions 1606 (or in other examples, tips as shown in the 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 a commissure window 1612 therein. For example, each axial strut 1610 may include a first window strut portion 1614a and a second window strut portion 1614b defining the commissure window 1612 and forming an upper (outflow) end portion 1616 above (or further toward the outflow end 1604) of the commissure window 1612 and a lower (or inflow) end portion 1618 below (or further toward the inflow end 1608) of the commissure window 1612. The lower end portion 1618 may be connected to a second series of angled struts 1602b, and the upper end portion 1616 may be connected to the angled struts 1602a.

[0233] In some examples, such as Fig. 30, a concave region 1620 (which may form or continue along the axial strut as a narrow or constricted region) may be formed in the upper end portion 1616 at a root or base of the angled strut 1602a to which it adjoins. In particular, a transition region 1632 between the angled strut 1602a and the axial strut 1610 may have three changes in concavity that result in lower stresses at the base of the angled strut 1602a where the angled strut 1602a connects to the upper portion 1616 of the axial strut 1610. The three changes in concavity include a first concave curve 1634 (or concave region) that transitions into a first convex curve 1636 (or convex region), and then a second concave curve 1635 that forms the concave region 1620.A fourth change in concavity may occur at the base of the upper portion 1616, as shown by the second convex curve 1638, which again merges into the wider portion of the axial strut 1610. Thus, a more gradual transition may be established between the narrower angled struts 1602a and a wider portion 1624 (with a greater width 1628) of the axial strut 1610. As a result, the maximum stresses occurring in the transition regions 1632 or at the base or root of the angled struts 1602a may be reduced, thereby increasing the durability of the frame 1600.

[0234] In some cases, each upper end portion 1616 of each axial strut 1610 may include two concave regions 1620 (or concavities), one on either side of the upper end portion 1616, at the base of the angled strut 1602a. As a result, narrowed regions 1622 having a smaller width 1626 are formed in the upper end portion 1616 adjacent to the angled struts 1602a. For example, the width 1626 of the narrowed regions 1622 may be greater than a width 1630 of the angled struts 1602a, but less than the width 1628 of the wider portion 1624 of the axial strut 1610.

[0235] In some examples, the lower end portion 1618 may also include concave areas 1620, thereby providing a more gradual transition between the wider portion 1624 of the axial strut 1601 and the angled struts 1602b.

[0236] Fig. 31 shows another example of a concave portion 1640 formed in the upper end portion 1616 at a base or root of the angled strut 1602a. The concave portion 1640 may be formed as a circumferentially extending indentation or depression in the upper end portion 1616 at the base of the angled strut 1602a. In some cases, as in Fig. 31, the concave region 1640 may be formed immediately adjacent to a convex curve 1644 in the base of the angled strut 1602a, which is immediately adjacent to another concave curve 1646 in the angled strut 1602a. Additionally, in some cases, the concave region 1640 may transition into another convex curve 1648 in the axial strut 1610.

[0237] The at least three changes in concavity between the concave curve 1646, the convex curve 1644, and the concave region 1640 (and optionally the fourth change in concavity at the concave curve 1646) may result in reduced stresses at the base of the angled strut 1602a where it is connected to the axial strut 1610. Although in Fig. 31 only one side of the axial strut is shown, in some examples both sides of the upper end portion 1616 may include a concave area 1640. Further, in some cases, the lower end portion 1618 of the axial strut 1610 may also include the concave areas 1640 at the base of the angled struts 1602b (similar to Fig. 30 shown).

[0238] In some examples, the concave areas 1640 of Fig. 31 or the concave areas 1620 of Fig. 30 may only be included on the axial struts (at the base of the angled struts to which they are connected) that define the commissure windows (e.g., the axially extending window strut sections described here).

[0239] In alternative examples, the concave areas 1640 of Fig. 31 or the concave areas 1620 of Fig. 30 on all axial struts of the frame at the base of the angled struts to which they are connected, including the axial struts forming the commissure windows and the axial struts without commissure windows (e.g. axial struts 232). Feeding techniques

[0240] To implant a prosthetic valve into the native aortic valve via a transfemoral delivery approach, the prosthetic valve is placed in a radially compressed state along the distal end of a delivery device. The prosthetic valve and the distal end of the delivery device are inserted into a femoral artery and advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery device, or deploying the prosthetic valve from a sheath to allow self-expansion of the prosthetic valve).Alternatively, a prosthetic valve can be implanted into the native aortic valve during a transapical procedure, whereby the prosthetic valve (at the distal end of the delivery device) is inserted through a surgical opening in the chest and at the apex of the heart into the left ventricle, and the prosthetic valve is positioned within the native aortic valve. Alternatively, during a transaortic procedure, a prosthetic valve (at the distal end of the delivery device) is inserted into the aorta through a surgical incision in the ascending aorta, e.g., a partial J-sternotomy or a right parasternal mini-thoracotomy, and then advanced through the ascending aorta to the native aortic valve.

[0241] For implantation of a prosthetic valve into the native mitral valve via a transseptal delivery approach, the prosthetic valve is placed in a radially compressed state along the distal end of a delivery device. The prosthetic valve and the distal end of the delivery device are inserted into a femoral vein and advanced through the inferior vena cava into the right atrium, through the atrial septum (through a puncture in the atrial septum) into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted into the native mitral valve using a transapical procedure, with the prosthetic valve (attached to the distal end of the delivery device) being inserted through a surgical opening in the chest and the apex of the heart into the left ventricle, and the prosthetic valve being positioned within the native mitral valve.

[0242] To implant a prosthetic valve into the native tricuspid valve, the prosthetic valve is placed in a radially compressed state along the distal end of a delivery device. The prosthetic valve and the distal end of the delivery device are inserted into a femoral vein and advanced through the inferior vena cava into the right atrium, where the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve into the native pulmonary valve or pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and to the pulmonary valve / pulmonary artery.

[0243] Another delivery approach is the transatrial approach, in which a prosthetic valve (at the distal end of the delivery device) is inserted through an incision in the chest and an incision is made through the atrial wall (of the right or left atrium) to access one of the native heart valves. Delivery into the atrium can also be achieved intravascularly, e.g., via a pulmonary vein. Another delivery method is the transventricular approach, in which a prosthetic valve (at the distal end of the delivery device) is inserted through an incision in the chest and an incision through the wall of the right ventricle (typically at or near the base of the heart) to implant the prosthetic valve in the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0244] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vascular system. Furthermore, the delivery methods presented here are not intended to be limiting. Each of the valve prostheses disclosed herein can be implanted using any of the various delivery methods and delivery devices known in the art. Additional examples of the disclosed technology

[0245] In view of the above-described embodiments of the disclosed subject matter, this application discloses the additional examples listed below. It should be noted that a feature of an example alone, or more than one feature of the example in combination, and optionally in combination with one or more features of one or more further examples, are further examples that also fall within the disclosure of this application.

[0246] Example 1. A heart valve prosthesis comprising: a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between an outflow end and an inflow end of the frame, the plurality of interconnected struts comprising a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end, each outflow strut comprising two angled strut sections connected by a tip region, and each inflow strut comprising two angled strut sections connected by a tip region;wherein each tip region curves between a corresponding pair of two angled strut sections, each tip region having a reduced width and a length extending over at least 25% of a total length of the outflow strut or the inflow strut, and wherein the reduced width is less than a width of the two angled strut sections;

[0247] Example 2. The heart valve prosthesis of any example herein, particularly example 1, wherein each outflow strut forms an outflow edge of a cell of a first row of cells at the outflow end and wherein each inflow strut forms an inflow edge of a cell of a second row of cells at the inflow end.

[0248] Example 3. The heart valve prosthesis of any example herein, especially example 2, wherein the cell of the first row of cells has a greater axial length, relative to a central longitudinal axis of the frame, than the cell of the second row of cells.

[0249] Example 4. The prosthetic heart valve of any example herein, particularly example 3, wherein the plurality of interconnected struts further comprises a plurality of axial struts extending in a direction of the central longitudinal axis and spaced from each other about a circumference of the frame, each axial strut forming an axial side of two adjacent cells of the first row of cells, and each axial strut having a width that is greater than a width of angled struts of the plurality of interconnected struts.

[0250] Example 5. The heart valve prosthesis of any example herein, particularly example 4, wherein for each axial strut, the width of the axial strut is a width of a central 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 central portion, the lower end portion including an opening.

[0251] Example 6. The prosthetic heart valve of any example herein, particularly example 5, further comprising an outer skirt disposed on an outer surface of the frame around a perimeter of the frame and secured to an outflow end portion of the plurality of interconnected struts, and wherein an outflow end of the outer skirt is secured to the opening of each axial strut.

[0252] Example 7. The prosthetic heart valve of any example herein, particularly example 6, wherein the outer skirt extends from the inflow end of the frame toward the outflow end and proximate the lower end portion of each axial strut.

[0253] Example 8. The prosthetic heart valve of any example herein, particularly any of Examples 1-7, wherein each tip region forms an angle between the two angled strut portions of a corresponding one of the outflow strut and inflow strut that is greater than 120 degrees and up to 140 degrees.

[0254] Example 9. The prosthetic heart valve of any example herein, particularly any of Examples 1-8, wherein each tip region has a curved outer surface with 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.

[0255] Example 10. The heart valve prosthesis of any example herein, particularly any of Examples 1-9, wherein the length of each tip region is in a range of 0.9 mm to 2.2 mm.

[0256] Example 11. The prosthetic heart valve of any example herein, particularly any of Examples 1-9, wherein the length of each tip region is in the range of 1.9 mm to 2.2 mm.

[0257] Example 12. The prosthetic heart valve of any example herein, particularly any of Examples 1-9, wherein the length of each tip region at the outflow end is in a range of 1.8 mm to 2.4 mm and wherein the length of each tip region at the inflow end is in a range of 0.8 mm to 1.2 mm.

[0258] Example 13. The prosthetic heart valve of any example herein, particularly any of Examples 1-12, wherein the reduced width of each tip region is 0.06 mm to 0.15 mm less than the width of the two angled strut portions.

[0259] Example 14. The prosthetic heart valve of any example herein, particularly any of Examples 1-13, wherein the width of the angled strut portions is 0.3 mm and the reduced width of each tip region is in a range of 0.15 mm to 0.24 mm.

[0260] Example 15. The prosthetic heart valve of any example herein, particularly any of Examples 1-14, wherein each tip region has a curved, axially facing outer surface continuous with axially facing outer surfaces of the two angled strut portions of a corresponding one of the outflow strut and the inflow strut, and an arcuate, axially facing inner recess, the inner recess being recessed from axially facing inner surfaces of the two angled strut portions toward the outer surface of the tip region.

[0261] Example 16. The prosthetic heart valve of any example herein, particularly any of Examples 1-15, wherein one or more of the tip regions are twisted about a transverse axis of the tip region such that the tip region has a twisted outer surface configured to be atraumatic.

[0262] Example 17. The heart valve prosthesis of any example herein, particularly any of Examples 1-16, further comprises a plurality of valve leaflets attached to the frame.

[0263] Example 18. The heart valve prosthesis of any example herein, particularly example 17, further comprising a plurality of commissure windows formed by struts of the plurality of interconnected struts forming cells of a first row of cells of the plurality of rows of cells, the first row of cells being disposed at the outflow end of the frame, and each commissure window being configured to receive commissure flaps of two adjacent valve leaflets of the plurality of valve leaflets.

[0264] Example 19. The prosthetic heart valve of any example herein, particularly example 18, wherein each commissure window is spaced from the outflow end of the frame by an upper axial strut extending between a junction between two adjacent outflow end struts and axially extending window strut portions defining the commissure window.

[0265] Example 20. The prosthetic heart valve of any example herein, particularly example 17, wherein each commissure window is defined by axially extending window strut portions forming an upper end portion above the commissure window and a lower end portion below the commissure window, and wherein a length, in an axial direction relative to a central longitudinal axis of the frame, of the upper end portion and the lower end portion is greater than the width of the two angled strut portions.

[0266] Example 21. A heart valve prosthesis comprising: a radially expandable and compressible annular frame comprising a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts comprising a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end, each of the plurality of outflow struts and the plurality of inflow struts comprising: two angled strut portions;and a tip portion disposed between the two angled strut portions, the tip portion comprising a curved, axially facing outer surface forming a single curve between the axially facing outer surfaces of the two angled strut portions, and an axially facing inner recess recessed inwardly from the axially facing inner surfaces of the two angled strut portions toward the curved outer surface of the tip portion such that a width of the tip portion is smaller than a width of the two angled strut portions.;

[0267] Example 22. The prosthetic heart valve of any example herein, especially example 21, wherein a radius of curvature of the curved outer surface of the tip region is greater than 1 mm.

[0268] Example 23. The prosthetic heart valve of any example herein, especially example 21, wherein the radius of curvature of the curved outer surface of the tip region is in a range of 8 mm to 14 mm.

[0269] Example 24. The prosthetic heart valve of any example herein, particularly example 22 or 23, wherein the curved outer surface curves continuously with the radius of curvature from an outer surface of a first angled strut portion of the two angled strut portions on a first side of the tip region to a second angled strut portion of the two angled strut portions on a second side of the tip region.

[0270] Example 25. The prosthetic heart valve of any example herein, particularly any of Examples 21-24, wherein the tip region forms an angle between the two angled strut portions that is greater than 120 degrees and less than or equal to 140 degrees.

[0271] Example 26. The prosthetic heart valve of any example herein, particularly any of Examples 21-24, wherein the tip region forms an angle between the two angled strut portions that is in a range of 135 degrees to 140 degrees.

[0272] Example 27. The prosthetic heart valve of any example herein, particularly any of Examples 21-26, wherein the tip region comprises a tip and two tapered strut portions, one disposed on either side of the tip, each narrow strut portion extending from the tip to a corresponding angled strut portion of the two angled strut portions, and each narrow strut portion of the tip region has a length in a range of 0.8 mm to 1.4 mm.

[0273] Example 28. The prosthetic heart valve of any example herein, particularly any of Examples 21-27, wherein the tip region comprises a tip and two narrow strut portions, one disposed on either side of the tip, each narrow strut portion extending from the tip to a corresponding angled strut portion of the two angled strut portions, and each narrow strut portion of the tip region has a length in a range of 0.95 mm to 1.05 mm.

[0274] Example 29. The prosthetic heart valve of any example herein, particularly any of Examples 21-28, wherein the plurality of rows of cells includes a first row of cells disposed at the outflow end of the frame and a second row of cells disposed at the inflow end of the frame, and wherein the cells of the first row of cells have a greater axial length, relative to a central longitudinal axis of the frame, than the cells of the second row of cells.

[0275] Example 30. The prosthetic heart valve of any example herein, particularly example 29, wherein the plurality of interconnected struts further comprises a plurality of axial struts extending in a direction of the central longitudinal axis and spaced from each other about a circumference of the frame, each axial strut forming an axial side of two adjacent cells of the first row of cells, and each axial strut having a width greater than a width of angled struts of the plurality of interconnected struts, the angled struts comprising angled struts that form the cells of the first row of cells with the axial struts.

[0276] Example 31. The prosthetic heart valve of any example herein, particularly example 30, wherein the width of the axial strut is a width of a central 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 central portion, the lower end portion including an opening.

[0277] Example 32. The prosthetic heart valve of any example herein, particularly Example 31, further comprises an outer skirt disposed on an outer surface of the frame around a perimeter of the frame and secured to an outflow end portion of the plurality of interconnected struts, and wherein an outflow end of the outer skirt is secured to the opening of each axial strut.

[0278] Example 33. The prosthetic heart valve of any example herein, particularly any of examples 21-32, wherein a length of each tip region is in a range of 0.9 mm to 2.2 mm.

[0279] Example 34. The prosthetic heart valve of any example herein, particularly any of examples 21-32, wherein a length of each tip region is in a range of 1.9 mm to 2.2 mm.

[0280] Example 35. The prosthetic heart valve of any example herein, particularly any of Examples 21-32, wherein a length of each tip region at the outflow end of the frame is in a range of 1.8 mm to 2.4 mm and wherein a length of each tip region at the inflow end of the frame is in a range of 0.8 mm to 1.2 mm.

[0281] Example 36. The prosthetic heart valve of any example herein, especially any of examples 21-35, wherein the width of the tip region is from 0.06 mm to 0.15 mm less than the width of the two angled strut portions.

[0282] Example 37. The prosthetic heart valve of any example herein, particularly any of Examples 21-36, wherein the width of the angled strut portions is 0.3 mm and the width of the tip region is in a range of 0.15 mm to 0.24 mm.

[0283] Example 38. The prosthetic heart valve of any example herein, particularly any of Examples 21-37, wherein one or more of the tip regions are twisted about a transverse axis of the tip region such that the tip region has a twisted outer surface configured to be atraumatic.

[0284] Example 39. The heart valve prosthesis of any example herein, particularly any of Examples 21-38, further comprising a plurality of valve leaflets attached to the frame, each valve leaflet comprising opposed commissure tabs disposed on opposite sides of the valve leaflet and a leaflet edge portion extending between the opposed commissure tabs, and wherein the leaflet edge portion of each valve leaflet is disposed adjacent the inflow end of the frame.

[0285] Example 40. The heart valve prosthesis of any example herein, particularly example 39, further comprising a plurality of commissure windows formed by struts of the plurality of interconnected struts forming cells of a first row of cells of the plurality of rows of cells, the first row of cells being disposed at the outflow end of the frame, and each commissure window being configured to receive a commissure flap from each of two adjacent valve leaflets of the plurality of valve leaflets.

[0286] Example 41. The prosthetic heart valve of any example herein, particularly example 40, wherein each commissure window is spaced from the outflow end of the frame by an upper axial strut extending between a junction between two adjacent outflow end struts and axially extending window strut portions defining the commissure window.

[0287] Example 42. The prosthetic heart valve of any example herein, particularly example 40, wherein each commissure window is defined by axially extending window strut portions forming an upper end portion above the commissure window and a lower end portion below the commissure window, and wherein a length in an axial direction relative to a central longitudinal axis of the frame of the upper end portion and the lower end portion is greater than the width of the two angled strut portions.

[0288] Example 43. The prosthetic heart valve of any example herein, particularly any of Examples 21-42, further comprising a cushioning member covering the curved outer surface of at least one tip of the tip region.

[0289] Example 44. A heart valve prosthesis comprising: a radially expandable and compressible annular frame comprising a plurality of interconnected struts defining a plurality of rows of cells disposed between an outflow end and an inflow end of the frame, the plurality of interconnected struts comprising a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end, each of the plurality of outflow struts and the plurality of inflow struts comprising: two angled strut portions;and a tip region disposed between the two angled strut portions, the tip region comprising a tip and two narrow strut portions extending outwardly from the tip in opposite directions relative to a central longitudinal axis of the tip region, a width of the two narrow strut portions being less than a width of the two angled strut portions and a combined length of the two narrow strut portions being at least 25% of a length of a corresponding outflow strut or inflow strut comprising the tip region.;

[0290] Example 45. The prosthetic heart valve of any example herein, particularly example 44, wherein each outflow strut forms an outflow edge of a cell of a first row of cells of the plurality of rows of cells, and wherein each outflow strut is connected to at least one axial strut of a plurality of axial struts of the frame, the at least one axial strut extending axially relative to the central longitudinal axis and forming an axial side of the cell.

[0291] Example 46. The prosthetic heart valve of any example herein, especially example 45, wherein the axial strut has a width greater than a width of angled struts of the plurality of interconnected struts, the angled struts comprising angled struts forming the cell of the first row of cells with the axial strut.

[0292] Example 47. The prosthetic heart valve of any example herein, especially example 46, wherein the width of the axial strut is a width of a central portion of the axial strut, and wherein the axial strut comprises a lower end portion and an upper end portion disposed on opposite sides of the central portion, the lower end portion comprising an opening.

[0293] Example 48. The prosthetic heart valve of any example herein, particularly example 47, further comprising an outer skirt disposed on an outer surface of the frame around a perimeter of the frame and secured to an outflow end portion of the plurality of interconnected struts, and wherein an outflow end of the outer skirt is secured to the opening of the axial strut.

[0294] Example 49. The prosthetic heart valve of any example herein, particularly any of Examples 44-48, wherein a height of the tip region defined in the axial direction from an axially facing outer surface of the two angled strut portions to an axially facing outer surface of the tip region at the tip is the width of the two narrow strut portions.

[0295] Example 50. The prosthetic heart valve of any example herein, particularly any of examples 44-49, wherein each narrow strut portion of the two narrow strut portions of the tip region has a length in a range of 0.8 mm to 1.4 mm.

[0296] Example 51. The prosthetic heart valve of any example herein, particularly any of examples 44-49, wherein each thinned strut portion of the two thinned strut portions of the tip region of each outflow strut has a first length in a range of 0.95-1.05 mm, and wherein each narrow strut portion of the two narrow strut portions of the tip region of each inflow strut has a second length in a range of 0.45-0.55 mm.

[0297] Example 52. The prosthetic heart valve of any example herein, especially any of examples 44-51, wherein each tip region forms an angle between the two angled strut portions that is greater than 120 degrees and up to 140 degrees.

[0298] Example 53. The prosthetic heart valve of any example herein, particularly any of Examples 44-52, wherein each tip region has a curved, axially facing outer surface with a radius of curvature greater than 1 mm, the curved outer surface extending between axially facing outer surfaces of the two angled strut portions.

[0299] Example 54. The prosthetic heart valve of any example herein, especially any of examples 44-53, wherein the width of the two narrow strut portions of each tip region is 0.06 mm to 0.15 mm less than the width of the two angled strut portions.

[0300] Example 55. The prosthetic heart valve of any example herein, particularly any of examples 44-53, wherein the width of the two angled strut portions is 0.3 mm and the width of the two narrow strut portions of each tip region is in a range of 0.15 mm to 0.24 mm.

[0301] Example 56. The prosthetic heart valve of any example herein, particularly any of Examples 44-55, wherein each tip region has a curved, axially facing outer surface and an arcuate, axially facing inner recess forming the two thinned strut portions of the tip regions, the curved outer surface being continuous with the axially facing outer surfaces of the two angled strut portions, and the inner recess sloping away from the axially facing inner surfaces of the two angled strut portions toward the curved outer surface.

[0302] Example 57. The prosthetic heart valve of any example herein, particularly any of Examples 44-55, wherein one or more of the tip regions are twisted about a transverse axis of the tip region such that the tip region has a twisted outer surface configured to be atraumatic.

[0303] Example 58. The prosthetic heart valve of any example herein, particularly any of Examples 44-56, further comprises a plurality of valve leaflets attached to the frame.

[0304] Example 59. The heart valve prosthesis of any example herein, particularly example 58, further comprising a plurality of commissure windows formed by struts of the plurality of interconnected struts forming cells of a first row of cells of the plurality of rows of cells, the first row of cells being disposed at the outflow end of the frame, and each commissure window being configured to receive commissure flaps of two adjacent valve leaflets of the plurality of valve leaflets.

[0305] Example 60. The prosthetic heart valve of any example herein, particularly example 59, wherein each commissure window is spaced from the outflow end of the frame by an upper axial strut extending between a junction between two adjacent outflow end struts and axially extending window strut portions defining the commissure window.

[0306] Example 61. The prosthetic heart valve of any example herein, particularly example 59, wherein each commissure window is defined by axially extending window strut portions forming an upper end portion above the commissure window and a lower end portion below the commissure window, and wherein a length in an axial direction relative to a central longitudinal axis of the frame of the upper end portion and the lower end portion is greater than the width of the two angled strut portions.

[0307] Example 62. The prosthetic heart valve of any example herein, particularly any of Examples 44-61, further comprising a cushioning member covering an outer surface of at least the tip of the tip region.

[0308] Example 63. A heart valve prosthesis comprising: a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between an outflow end and an inflow end of the frame, the plurality of interconnected struts comprising a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end, each outflow strut comprising two angled strut sections connected by a tip region, and each inflow strut comprising two angled strut sections connected by a tip region;and wherein each tip region curves between a corresponding pair of two angled strut sections, each tip region having a reduced width relative to a width of the two angled strut sections, and each tip region forming an angle between the two angled strut sections that is greater than 120 degrees.;

[0309] Example 64. The prosthetic heart valve of any example herein, especially example 63, wherein the angle is greater than 120 degrees and up to 140 degrees.

[0310] Example 65. The prosthetic heart valve of any example herein, especially example 63 or 64, wherein the angle is in a range of 135 degrees to 140 degrees.

[0311] Example 66. The prosthetic heart valve of any example herein, particularly any of Examples 63-65, wherein each tip region has a curved, axially facing outer surface continuous with the axially facing outer surfaces of the two angled strut portions, and an axially facing inner recess, the inner recess being depressed from the axially facing inner surfaces of the two angled strut portions toward the curved outer surface.

[0312] Example 67. The prosthetic heart valve of any example herein, especially example 66, wherein the curved outer surface of the tip region has a radius of curvature of greater than 1 mm.

[0313] Example 68. The prosthetic heart valve of any example herein, especially example 67, wherein the curved outer surface of the tip region forms a single, continuous curve, defined by the radius of curvature, between the outer surfaces of the two angled strut portions.

[0314] Example 69. The prosthetic heart valve of any example herein, particularly any of Examples 63-68, wherein each outflow strut forms an outflow edge of a cell of a first row of cells disposed at the outflow end of the frame, wherein each inflow strut forms an inflow edge of a cell of a second row of cells disposed at the inflow end of the frame, and wherein the cell of the first row of cells has a greater axial length relative to the central longitudinal axis of the frame than the cell of the second row of cells.

[0315] Example 70. The prosthetic heart valve of any example herein, particularly example 69, wherein the plurality of interconnected struts further comprises a plurality of axial struts extending in a direction of the central longitudinal axis and spaced from each other about a circumference of the frame, each axial strut forming an axial side of two adjacent cells of the first row of cells, and each axial strut having a width that is greater than a width of angled struts of the plurality of interconnected struts.

[0316] Example 71. The prosthetic heart valve of any example herein, especially example 70, wherein the width of the axial strut is a width of a central 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 central portion, the lower end portion including an opening.

[0317] Example 72. The prosthetic heart valve of any example herein, particularly example 71, further comprises an outer skirt disposed on an outer surface of the frame around a perimeter of the frame and secured to an outflow end portion of the plurality of interconnected struts, and wherein an outflow end of the outer skirt is secured to the opening of each axial strut.

[0318] Example 73. The prosthetic heart valve of any example herein, especially example 72, wherein the outer skirt extends from the inflow end of the frame toward the outflow end and proximate the lower end portion of each axial strut.

[0319] Example 74. The prosthetic heart valve of any example herein, especially any of examples 63-73, wherein the length of each tip region is at least 25% of the total length of the outflow strut or inflow strut formed by the tip region with the two angled strut portions.

[0320] Example 75. The prosthetic heart valve of any example herein, especially example 74, wherein the length of each tip region is in a range of 0.9 mm to 2.2 mm.

[0321] Example 76. The prosthetic heart valve of any example herein, especially example 74, wherein the length of each tip region is in a range of 1.9 mm to 2.2 mm.

[0322] Example 77. The prosthetic heart valve of any example herein, especially example 74, wherein the length of each tip region at the outflow end is in a range of 1.8 mm to 2.4 mm and wherein the length of each tip region at the inflow end is in a range of 0.8 mm to 1.2 mm.

[0323] Example 78. The prosthetic heart valve of any example herein, especially any of examples 63-77, wherein the narrowed or reduced width of each tip region is from 0.06 mm to 0.15 mm less than the width of the two angled strut portions.

[0324] Example 79. The prosthetic heart valve of any example herein, particularly any of Examples 63-78, wherein the width of the angled strut portions is 0.3 mm and the narrowed width of each tip region is in a range of 0.15 mm to 0.24 mm.

[0325] Example 80. The prosthetic heart valve of any example herein, particularly any of Examples 63-79, wherein one or more of the tip regions are twisted about a transverse axis of the tip region such that the tip region has a twisted outer surface configured to be atraumatic.

[0326] Example 81. The prosthetic heart valve of any example herein, particularly any of Examples 63-80, further comprising a plurality of valve leaflets attached to the frame, and further comprising a plurality of commissure windows formed by struts of the plurality of interconnected struts forming cells of a first row of cells of the plurality of rows of cells, the first row of cells being disposed at the outflow end of the frame, and each commissure window being configured to receive commissure tabs from two adjacent valve leaflets of the plurality of valve leaflets.

[0327] Example 82. The prosthetic heart valve of any example herein, particularly example 81, wherein each commissure window is spaced from the outflow end of the frame by an upper axial strut extending between a junction between two adjacent outflow end struts and axially extending window strut portions defining the commissure window.

[0328] Example 83. The prosthetic heart valve of any example herein, particularly example 81, wherein each commissure window is defined by axially extending window strut portions forming an upper end portion above the commissure window and a lower end portion below the commissure window, and wherein a length of the upper end portion and the lower end portion in an axial direction relative to the central longitudinal axis of the frame is greater than the width of the two angled strut portions.

[0329] Example 84. A heart valve prosthesis comprising: a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between an outflow end and an inflow end of the frame, the plurality of interconnected struts comprising a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end, each outflow strut comprising two angled strut sections connected by a tip region, and each inflow strut comprising two angled strut sections connected by a tip region;and wherein each tip region curves between a corresponding pair of two angled strut sections, each tip region having a reduced width relative to a width of the two angled strut sections, and wherein each tip region is configured to plastically deform during initial radial compression of the frame so as to strain harden it and shift the bending points of the frame toward the ends of the angled strut sections, away from the tip region, during subsequent radial expansion.;

[0330] Example 85. A heart valve prosthesis comprising: a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end and an outflow end of the frame, the plurality of rows of cells including a first row of cells disposed at the outflow end, the cells of the first row of cells having a greater axial length than the cells of the remaining rows of cells of the plurality of rows of cells; and a plurality of axial struts, each axial strut defining an axial side of two adjacent cells of the first row of cells and comprising: a central 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 at opposite ends of the central portion and each wider than the width of the central portion;

[0331] Example 86. The prosthetic heart valve of any example herein, particularly example 85, wherein the lower end portion has an opening.

[0332] Example 87. The prosthetic heart valve of any example herein, particularly example 86, further comprising an outer skirt disposed on an outer surface of the frame around a perimeter of the frame and secured to an outflow end portion of the plurality of interconnected struts, and wherein an outflow end of the outer skirt is secured to the opening of each axial strut.

[0333] Example 88. The prosthetic heart valve of any example herein, particularly any of examples 85-87, wherein each row of cells of the plurality of rows of cells comprises nine cells, and wherein the plurality of rows of cells comprises three rows of cells.

[0334] Example 89. The prosthetic heart valve of any example herein, particularly any of Examples 85-88, further comprising a plurality of commissure windows defined by axially extending window strut portions of the frame, and wherein each commissure window is defined by a set of window strut portions that form axial sides of two adjacent cells of the first row of cells.

[0335] Example 90. The heart valve prosthesis of any example herein, particularly example 89, further comprising a plurality of valve leaflets attached to the frame, each valve leaflet including opposed commissure tabs disposed on opposite sides of the leaflet and a leaflet margin portion extending between the opposed commissure tabs, and each commissure window configured to receive commissure tabs from two adjacent leaflets of the plurality of leaflets.

[0336] Example 91. The prosthetic heart valve of any example herein, particularly example 89 or 90, wherein the set of window strut portions of each commissural window and each axial strut extends between two corresponding angled struts of a first series of angled struts disposed at the outflow end of the frame and two angled struts of a second series of angled struts, and wherein two adjacent axial struts are disposed between two sets of window strut portions around a perimeter of the frame.

[0337] Example 92. The prosthetic heart valve of any example herein, especially example 91, wherein the set of window strut portions of each commissure window forms an upper end portion above the commissure window and a lower end portion below the commissure window, and wherein a length in an axial direction relative to the central longitudinal axis of the frame of the upper end portion and the lower end portion of the set of window strut portions is greater than the width of the two angled struts of the first row of angled struts and the two angled struts of the second row of angled struts.

[0338] Example 93. The prosthetic heart valve of any example herein, particularly any of Examples 85-92, wherein the plurality of interconnected struts comprises a plurality of outflow struts defining the outflow end of the frame and a plurality of inflow struts defining the inflow end of the frame, and wherein each outflow strut and each inflow strut comprises two angled strut portions and a tip region disposed between the two angled strut portions, the tip region having a curved, axially facing outer surface forming a single curve between axially facing outer surfaces of the two angled strut portions, and an axially facing inner recess depressed inwardly from axially facing inner surfaces of the two angled strut portions toward the curved outer surface of the tip region such thatthat a width of the tip area is smaller than a width of the two angled strut sections.,

[0339] Example 94. The prosthetic heart valve of any example herein, especially example 93, wherein the curved outer surface of the tip region has a radius of curvature in a range of 1 mm to 20 mm.

[0340] Example 95. The prosthetic heart valve of any example herein, particularly example 93 or 94, wherein the inner recess of one cell faces the plurality of rows of cells and the curved outer surface is disposed opposite the inner recess across the width of the tip region.

[0341] Example 96. The prosthetic heart valve of any example herein, especially any of examples 93-95, wherein a length of the tip region is at least 25% of a length of the outflow strut or inflow strut including the tip region.

[0342] Example 97. The prosthetic heart valve of any example herein, especially any of examples 93-96, wherein the tip region forms an angle between the two angled strut portions that is greater than 120 degrees and up to 140 degrees.

[0343] Example 98. The prosthetic heart valve of any example herein, particularly any of examples 93-97, wherein a height of the tip region defined in an axial direction from an axially facing outer surface of the two angled strut portions to an axially facing outer surface of the tip region at an apex of the tip region is the width of the tip region.

[0344] Example 99. A heart valve prosthesis comprising: a radially expandable and compressible annular frame comprising a plurality of interconnected struts defining a plurality of rows of cells disposed between an outflow end and an inflow end of the frame, the plurality of interconnected struts comprising a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end, each of the plurality of outflow struts and the plurality of inflow struts comprising: two angled strut portions;and a tip disposed between the two angled strut portions, the tip having an axially facing inner surface including two inner depressions depressed into the inner surface and a central bump projecting from and disposed between the two inner depressions, the two inner depressions forming narrow regions of the tip that are smaller in width than a width of the two angled strut portions;

[0345] Example 100. The prosthetic heart valve of any example herein, especially example 99, wherein the two inner depressions form narrow regions of the apex on either side of the cusp, the narrow regions having a width less than the width of the two angled strut portions.

[0346] Example 101. The prosthetic heart valve of any example herein, especially example 100, wherein the tip at the central cusp has a width that is greater than the width of the thinned regions of the tip, but less than the width of the two angled strut portions.

[0347] Example 102. The prosthetic heart valve of any example herein, especially any of examples 99-101, wherein the height of the cusp is in a range of 10 µm to 50 µm.

[0348] Example 103. The prosthetic heart valve of any example herein, particularly any of Examples 99-102, wherein the tip has a curved, axially facing outer surface that curves between the axially facing outer surfaces of the two angled strut portions, and wherein the two depressions extend from the axially facing inner surfaces of the two angled strut portions toward the outer surface of the tip.

[0349] Example 104. The prosthetic heart valve of any example herein, especially any of examples 99-103, wherein each apex forms an angle between the two angled strut portions that is greater than 120 degrees and up to 140 degrees.

[0350] Example 105. The prosthetic heart valve of any example herein, particularly any of examples 99-104, wherein the narrow regions of the tip have a width that is from 0.06 mm to 0.15 mm less than the width of the two angled strut portions.

[0351] Example 106. The prosthetic heart valve of any example herein, particularly any of examples 99-105, further comprising a plurality of valve leaflets attached to the frame.

[0352] Example 107. The prosthetic heart valve of any example herein, particularly example 106, further comprising a plurality of commissure windows formed by struts of the plurality of interconnected struts forming cells of a first row of cells of the plurality of rows of cells, the first row of cells being disposed at the outflow end of the frame, and each commissure window being configured to receive commissure flaps of two adjacent valve leaflets of the plurality of valve leaflets.

[0353] Example 108. The prosthetic heart valve of any example herein, particularly example 107, wherein each commissure window is spaced from the outflow end of the frame by an upper axial strut extending between a junction between two adjacent outflow end struts and axially extending window strut portions defining the commissure window.

[0354] Example 109. The prosthetic heart valve of any example herein, particularly example 107, wherein each commissure window is defined by axially extending window strut portions forming an upper end portion above the commissure window and a lower end portion below the commissure window, and wherein a length in an axial direction relative to the central longitudinal axis of the frame of the upper end portion and the lower end portion is greater than the width of the two angled strut portions.

[0355] Example 110. The prosthetic heart valve of any example herein, particularly any of Examples 99-109, wherein each outflow strut forms an outflow edge of a cell of a first row of cells of the plurality of rows of cells at the outflow end, and wherein each inflow strut forms an inflow edge of a cell of a second row of cells of the plurality of rows of cells at the inflow end.

[0356] Example 111. The prosthetic heart valve of any example herein, especially example 110, wherein the cell of the first row of cells has a greater axial length, relative to a central longitudinal axis of the frame, than the cell of the second row of cells.

[0357] Example 112. The prosthetic heart valve of any example herein, particularly example 111, wherein the plurality of interconnected struts further comprises a plurality of axial struts extending in a direction of the central longitudinal axis and spaced from each other about a circumference of the frame, each axial strut forming an axial side of two adjacent cells of the first row of cells, and each axial strut having a width that is greater than a width of angled struts of the plurality of interconnected struts.

[0358] Example 113. The prosthetic heart valve of any example herein, particularly example 112, wherein for each axial strut, the width of the axial strut is a width of a central portion of the axial strut, and wherein the axial strut further comprises an upper end portion and a lower end portion disposed at opposite ends of the central portion, wherein each of the upper end portion and the lower end portion is wider than the width of the central portion.

[0359] Example 114. A prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between a first end and a second end of the frame, the plurality of interconnected struts comprising a plurality of first struts defining the first end and a plurality of second struts defining the second end, each first strut comprising two angled strut portions interconnected by a tip; and wherein each tip of one or more tips at the first end is bent between a corresponding pair of two angled strut portions, has a reduced width relative to a width of the two angled strut portions, and includes a central bulge extending from an axially facing inner surface of the tip.

[0360] Example 115. The prosthetic heart valve of any example herein, especially example 114, wherein the axially facing inner surface of each tip of the one or more prosthetic valves has two inner depressions, the cusp separating the two inner depressions, each inner depression of the two inner depressions being urged inwardly by the cusp and an axially facing inner surface of a corresponding one of the two angled strut portions.

[0361] Example 116. The prosthetic heart valve of any example herein, particularly example 115, wherein for each tip of the one or more prosthetic valves, a width of the tip at each of the two inner depressions is less than the width of the two angled strut portions, and wherein a width of the tip at the cusp is less than the width of the two angled strut portions and greater than the width of the tip at each of the two inner depressions.

[0362] Example 117. The prosthetic heart valve of any example herein, particularly any of examples 114-116, wherein for each tip of the one or more tips, a height of the cusp in an axial direction is in a range of 10 µm to 50 µm.

[0363] Example 118. The prosthetic heart valve of any example herein, particularly any of examples 114-117, wherein for each tip of the one or more tips, a tip of the tip and a tip of the cusp are aligned along a central longitudinal axis of the tip.

[0364] Example 119. The prosthetic heart valve of any example herein, particularly any of examples 114-118, wherein each tip of the one or more strut portions has a curved, axially facing outer surface that curves between the axially facing outer surfaces of the two angled strut portions.

[0365] Example 120. The prosthetic heart valve of any example herein, particularly any of examples 114-119, wherein each tip of the one or more strut portions forms an angle between the two angled strut portions that is greater than 120 degrees and up to 140 degrees.

[0366] Example 121. The prosthetic heart valve of any example herein, particularly any of Examples 114-120, further comprising a plurality of valve leaflets attached to the frame, and a plurality of commissural windows formed by struts of the plurality of interconnected struts forming cells of a first row of cells of the plurality of rows of cells, wherein the first row of cells is disposed at the first end of the frame that is an outflow end of the frame, and wherein each commissural window is configured to receive commissural tabs of two adjacent valve leaflets of the plurality of valve leaflets.

[0367] Example 122. The prosthetic heart valve of any example herein, particularly example 121, wherein each commissure window is spaced from the outflow end of the frame by an upper axial strut extending between a junction between two adjacent outflow end struts and axially extending window strut portions defining the commissure window.

[0368] Example 123. The prosthetic heart valve of any example herein, particularly any of Examples 114-122, wherein the first end is an outflow end and the second end is an inflow end, wherein each first strut forms an outflow edge of a cell of a first row of cells of the plurality of rows of cells at the outflow end, wherein each second strut forms an inflow edge of a cell of a second row of cells of the plurality of rows of cells at the inflow end, and wherein the cell of the first row of cells has a greater axial length, relative to a central longitudinal axis of the frame, than the cell of the second row of cells.

[0369] Example 124. The prosthetic heart valve of any example herein, particularly example 123, wherein the plurality of interconnected struts further comprises a plurality of axial struts extending in a direction of the central longitudinal axis and spaced from each other about a circumference of the frame, each axial strut forming an axial side of two adjacent cells of the first row of cells, and each axial strut having a width that is greater than a width of angled struts of the plurality of interconnected struts.

[0370] Example 125. The prosthetic heart valve of any example herein, particularly example 124, wherein for each axial strut, the width of the axial strut is a width of a central portion of the axial strut, and wherein the axial strut further comprises an upper end portion and a lower end portion disposed at opposite ends of the central portion, wherein each of the upper end portion and the lower end portion is wider than the width of the central portion.

[0371] Example 126. The prosthetic heart valve of any example herein, particularly any of Examples 114-125, wherein each second strut comprises two angled strut portions connected by a tip, and wherein each tip of one or more strut portions is curved at the second end between a corresponding pair of two angled strut portions, has a reduced width relative to a width of the two angled strut portions, and includes a central bulge extending from an axially facing inner surface of the tip.

[0372] Example 127. The prosthetic heart valve of any example herein, particularly any of examples 114-126, wherein the one or more first end tips include each individual first end tip.

[0373] Example 128. A prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end and an outflow end of the frame, the plurality of rows of cells including a first row of cells disposed at the outflow end; and a plurality of axial struts, each axial strut defining an axial side of two adjacent cells of the first row of cells and having a width greater than a width of angled struts of the plurality of interconnected struts, each axial strut including one or more slots or recesses disposed along a length of the axial strut, the one or more slots or recesses extending through a portion of the width of the axial strut.

[0374] Example 129. The prosthetic heart valve of any example herein, particularly example 128, wherein each slot or recess of the one or more slots or recesses extends from one side edge of two side edges defining the axial strut to another side edge of the two side edges, the two side edges being disposed opposite each other transversely to the axial strut.

[0375] Example 130. The prosthetic heart valve of any example herein, especially example 129, wherein the width of the axial strut is in a range of 0.5 to 1.0 mm, and wherein each slot or recess of the one or more slots or recesses has a closed end spaced from one of the two lateral edges by a distance in a range of 0.1 to 0.3 mm.

[0376] Example 131. The prosthetic heart valve of any example herein, particularly example 129 or example 130, wherein the one or more slots or recesses comprise a plurality of slots or recesses spaced apart from one another along the length of the axial strut, wherein a first portion of the slots of the plurality of slots extends from a first lateral edge of the two lateral edges to a second lateral edge of the two lateral edges, and wherein a second portion of the slots of the plurality of slots extends from the second lateral edge to the first lateral edge.

[0377] Example 132. The prosthetic heart valve of any example herein, particularly any of examples 128-131, wherein each slot or recess has an axial height in a range of 0.075 to 0.3 mm.

[0378] Example 133. The prosthetic heart valve of any example herein, particularly any of examples 128-132, wherein the one or more slots or recesses are configured to increase compliance of the axial strut.

[0379] Example 134. The prosthetic heart valve of any example herein, particularly any of Examples 128-133, wherein the one or more slots or recesses comprise a plurality of slots or recesses spaced apart from one another along the length of the axial strut, and wherein the plurality of slots are arranged in a plurality of groups of a plurality of slots, each group being spaced apart from an adjacent group by an amount greater than a distance between the plurality of slots of a same group.

[0380] Example 135. The prosthetic heart valve of any example herein, particularly example 134, wherein each group of multiple slots or multiple recesses comprises two slots or two recesses, each of the two slots extending through a portion of the width of the axial strut from a different one of two side edges defining the axial strut, the width being defined between the two side edges.

[0381] Example 136. The prosthetic heart valve of any example herein, particularly example 134 or example 135, wherein the plurality of groups of multiple slits comprises three groups of two slits or recesses.

[0382] Example 137. The prosthetic heart valve of any example herein, especially any of examples 128-136, wherein the cells of the first row of cells have a greater axial length than the cells of the remaining rows of cells of the plurality of rows of cells.

[0383] Example 138. A prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end and an outflow end of the frame, the plurality of rows of cells including a first row of cells disposed at the outflow end; and a plurality of axial struts, each axial strut defining an axial side of two adjacent cells of the first row of cells and having a width greater than a width of angled struts of the plurality of interconnected struts, each axial strut including a plurality of slots spaced apart along a length of the axial strut, each slot of the plurality of slots extending through a portion of the width of the axial strut.

[0384] Example 139. A prosthetic heart valve comprising: a radially expandable and compressible frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between a first end and a second end of the frame, the plurality of interconnected struts comprising a plurality of first struts defining the first end and a plurality of second struts defining the second end, each first strut comprising: 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 reduced width relative to a width of the two angled strut portions; and a cover member wrapped around and covering the tip region of the frame.

[0385] Example 140. The prosthetic heart valve of any example herein, particularly example 139, wherein the cover member comprises a plurality of consecutive loops of a strip or ribbon of material.

[0386] Example 141. The prosthetic heart valve of any example herein, especially example 140, wherein the tip region of the frame comprises a tip and two narrow strut portions extending outwardly from the tip in opposite directions, a width of the two narrow strut portions being narrower than a width of the two angled strut portions, the tip region having shoulders on either side of the tip region that transition from the narrower two narrow strut portions of the tip region to the wider two angled strut portions, and the plurality of successive loops of the strip or band of material are wrapped around the two narrow strut portions between the shoulders of the tip region.

[0387] Example 142. The heart valve prosthesis of any example herein, particularly example 140 or 141, wherein the material of the cover member comprises PTFE, UHMWPE, or PEEK.

[0388] Example 143. The prosthetic heart valve of any example herein, particularly any of examples 140-142, wherein the cover member comprises a plurality of bridge portions, each bridge portion extending between the plurality of loops of adjacent tip regions, the plurality of bridge portions extending along the first end of the frame.

[0389] Example 144. The prosthetic heart valve of any example herein, particularly example 139, wherein the cover member comprises a flap of a skirt disposed around a first surface of the frame.

[0390] Example 145. The prosthetic heart valve of any example herein, particularly example claim 144, wherein the first surface is an inner surface of the frame.

[0391] Example 146. The prosthetic heart valve of any example herein, particularly example claim 144, wherein the first surface is an outer surface of the frame.

[0392] Example 147. The prosthetic heart valve of any example herein, particularly any of Examples 144-146, wherein the flap extends from a first edge of the skirt that is attached to the first end of the frame, and wherein the flap wraps around the apex region from the first surface to an opposite, second surface of the frame.

[0393] Example 148. The prosthetic heart valve of any example herein, particularly any of Examples 144-147, wherein the skirt comprises a plurality of flaps spaced apart from each other about a first edge of the skirt, and wherein the first edge and the plurality of flaps are attached to the first end of the frame with a plurality of stitches extending through the skirt and around the plurality of first struts.

[0394] Example 149. The prosthetic heart valve of any example herein, particularly any of examples 139-148, wherein the first end is an inflow end of the frame.

[0395] Example 150. The prosthetic heart valve of any example herein, particularly any of examples 139-149, wherein each tip region forms an angle between the two angled strut portions of a corresponding first strut that is greater than 120 degrees and up to 140 degrees.

[0396] Example 151. A heart valve prosthesis comprising: a radially expandable and compressible annular frame comprising a plurality of interconnected struts defining a plurality of rows of cells disposed between an outflow end and an inflow end of the frame, the plurality of interconnected struts comprising a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end, each of the plurality of inflow struts comprising: two angled strut portions;and a tip portion disposed between the two angled strut portions, the tip portion having a curved, axially facing outer surface forming a single curve between axially facing outer surfaces of the two angled strut portions, and an axially facing inner recess depressed inwardly from the axially facing inner surfaces of the two angled strut portions toward the curved outer surface of the tip portion such that a width of the tip portion is smaller than a width of the two angled strut portions and shoulders are formed at both ends of the tip portion transitioning from the smaller width of the tip portion to the width of the two angled strut portions;and a cover member having a plurality of loops wrapped around and covering at least a portion of the toe portion of the frame between the shoulders of the toe portion;

[0397] Example 152. The prosthetic heart valve of any example herein, particularly example 151, wherein the cover member further comprises a plurality of bridge portions, each bridge portion extending between the plurality of loops of adjacent tip regions, the plurality of bridge portions extending around the inflow end of the frame.

[0398] Example 153. The prosthetic heart valve of any example herein, particularly example 151 or 152, wherein the cover member comprises a band of a material having a dynamic coefficient of friction of less than 0.1 with respect to an inner wall of a delivery sheath through which the prosthetic heart valve is advanced when guided to an implantation site.

[0399] Example 154. The prosthetic heart valve of any example herein, particularly any of examples 151-153, wherein the cover member covers the tip region of each inflow strut without covering the two angled strut portions of each inflow strut.

[0400] Example 155. A prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising a plurality of interconnected struts defining a plurality of rows of cells disposed between a first end and a second end of the frame, the plurality of interconnected struts comprising a plurality of first struts defining the first end and a plurality of second struts defining the second end, each of the plurality of first struts comprising a tip region; and a skirt disposed around one of an inner surface and an outer surface of the frame and connected to the frame, the skirt comprising: a first edge extending around a perimeter of the skirt and connected to the first end of the frame;and a plurality of axially extending flaps extending from the first edge and spaced apart from one another, each flap of the plurality of axially extending flaps being wrapped around a respective tip region such that the tip region is covered;

[0401] Example 156. The prosthetic heart valve of any example herein, especially example 155, wherein the skirt is disposed around the inner surface of the frame and each valve wraps around the corresponding apex region from the inner surface to the outer surface of the frame and is secured to the apex region.

[0402] Example 157. The prosthetic heart valve of any example herein, especially example 155, wherein the skirt is disposed around the outer surface of the frame and each valve wraps around the corresponding apex region from the outer surface to the inner surface of the frame and is secured to the apex region.

[0403] Example 158. The prosthetic heart valve of any example herein, particularly any of examples 155-157, wherein each of the plurality of first struts comprises: two angled strut portions; and the tip region disposed between the two angled strut portions, the tip region comprising a tip and two thinned strut portions extending outwardly from the tip in opposite directions with respect to a central longitudinal axis of the tip region, wherein a width of the two thinned strut portions is less than a width of the two angled strut portions.

[0404] Example 159. The prosthetic heart valve of any example herein, especially example 158, wherein each valve is wrapped around the corresponding tip region without wrapping the two angled strut portions in their entirety.

[0405] Example 160. The prosthetic heart valve of any example herein, especially example 158 or 159, wherein a combined length of the two narrow strut portions is at least 25% of a length of a corresponding first strut comprising the tip region.

[0406] Example 161. The prosthetic heart valve of any example herein, particularly any of examples 155-160, wherein the first end of the frame is an inflow end.

[0407] Example 162. A prosthetic heart valve comprising: a radially expandable and compressible frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between a first end and a second end of the frame, the plurality of interconnected struts comprising a plurality of first struts defining the first end and a plurality of second struts defining the second end, each first strut comprising: two angled strut portions; and a tip region disposed between the two angled strut portions, the tip region curving between the two angled strut portions and having a reduced width relative to a width of the two angled strut portions; an outer skirt disposed around an outer surface of the frame;and a cover member including a plurality of loops extending around the top portion of the frame and through the outer skirt so that the outer skirt is secured to the frame;

[0408] Example 163. The prosthetic heart valve of any example herein, especially example 162, wherein the plurality of loops wrap around and cover the tip region.

[0409] Example 164. The prosthetic heart valve of any example herein, particularly either Example 162 or Example 163, wherein the tip region comprises a curved, axially facing outer surface forming a single curve between axially facing outer surfaces of the two angled strut portions and an axially facing inner depression depressed inwardly from the axially facing inner surfaces of the two angled strut portions toward the curved outer surface of the tip region to form shoulders at both ends of the tip region that blend from the narrowed width of the tip region into the width of the two angled strut portions.

[0410] Example 165. The prosthetic heart valve of any example herein, especially example 164, wherein the plurality of loops cover the tip region between the shoulders of the tip region.

[0411] Example 166. The prosthetic heart valve of any example herein, particularly any of examples 162-165, wherein the cover member further comprises a plurality of stitches extending through a peripheral portion of the outer skirt between adjacent tip portions at the first end of the frame.

[0412] Example 167. The prosthetic heart valve of any example herein, particularly any of examples 162-166, wherein the first end of the frame is an inflow end of the frame.

[0413] Example 168. The prosthetic heart valve of any example herein, particularly any of examples 162-167, wherein the covering member is a suture.

[0414] Example 169. The prosthetic heart valve of any example herein, particularly any of examples 162-168, wherein a material of the cover member comprises PTFE, UHMWPE, or PEEK.

[0415] Example 170. A prosthetic heart valve comprising: a radially expandable and compressible annular frame comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end and an outflow end of the frame, the plurality of rows of cells including a first row of cells disposed at the outflow end; and a plurality of commissure windows, each commissure window formed by a set 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 cells, and an outflow end portion of the set of window strut portions disposed above the commissure window including two openings disposed therein.

[0416] Example 171. The prosthetic heart valve of any example herein, especially example 170, wherein the set of window strut portions defines an axial side of two adjacent cells of the first row of cells.

[0417] Example 172. The prosthetic heart valve of any example herein, particularly either example 170 or example 171, wherein the first series of interconnected struts forms the outflow end of the frame.

[0418] Example 173. The heart valve prosthesis of any example herein, particularly any of examples 170-172, further comprising a plurality of valve leaflets disposed within the frame, and wherein each commissure window is configured to receive commissure tabs from two adjacent valve leaflets of the plurality of valve leaflets.

[0419] Example 174. The prosthetic heart valve of any example herein, particularly example 173, wherein the two openings are configured to receive one or more fasteners to secure the commissure tabs within the commissure window.

[0420] Example 175. The prosthetic heart valve of any example herein, particularly any of examples 170-174, wherein the two openings are axially spaced from each other.

[0421] Example 176. The prosthetic heart valve of any example herein, particularly any of examples 170-175, wherein the two openings are axially aligned with each other.

[0422] Example 177. A heart valve prosthesis comprising: a radially expandable and compressible annular frame comprising a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end and an outflow end of the frame, the plurality of interconnected struts comprising: a plurality of rows of angled struts including a first row of angled struts defining the outflow end and a second row of angled struts;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 commissure window therein and having a first end portion disposed on a first side of the commissure window and connected to the first row of angled struts, the first end portion having a concave region in which the first end portion directly connects to a convex curve in a base of an angled strut of the first row of angled struts;

[0423] Example 178. The prosthetic heart valve of any example herein, particularly example 177, wherein the first end portion has two concave regions, one on either side of the first end portion, adjacent a respective convex bulge in a base of a respective angled strut of the first series of angled struts.

[0424] Example 179. The prosthetic heart valve of any example herein, particularly either Example 177 or Example 178, wherein each axially extending strut has a width greater than a width of the angled struts of the first series of angled struts, and wherein the concave region forms a constricted region in the first end portion of the axial strut.

[0425] Example 180. The prosthetic heart valve of any example herein, particularly any of Examples 177-179, wherein each axially extending strut has a second end portion disposed on a second side of the commissure window and connected to the second series of angled struts, and wherein the second end portion has a concave region therein adjacent where the second end portion is connected to an angled strut of the second series of angled struts.

[0426] Example 181. The prosthetic heart valve of any example herein, particularly any of examples 177-180, wherein the convex curvature in the base of the angled strut extends from a concave curvature in the angled strut such that a transition region having three changes in concavity is defined between the angled strut and the first end portion of the axially extending strut.

[0427] Example 182. The prosthetic heart valve of any example herein, particularly any of Examples 177-181, wherein the plurality of rows of cells includes a first row of cells disposed at the outflow end, and wherein each axially extending strut defines an axial side of two adjacent cells of the first row of cells.

[0428] Example 183. The prosthetic heart valve of any example herein, particularly any of Examples 1-20, wherein the plurality of interconnected struts comprises a plurality of horizontal struts extending between and spacing apart adjacent cells of a same row of cells of the plurality of rows of cells.

[0429] Example 184. The prosthetic heart valve of any example herein, especially example 183, wherein each horizontal strut interconnects two angled struts of a first row of angled struts and two angled struts of an adjacent second row of angled struts.

[0430] Example 185. The prosthetic heart valve of any example herein, particularly any of Examples 128-137, wherein the plurality of interconnected struts comprises a plurality of horizontal struts extending between and spacing apart adjacent cells of a same row of cells.

[0431] Example 186. The prosthetic heart valve of any example herein, especially example 185, wherein each horizontal strut interconnects two angled struts of a first row of angled struts and two angled struts of an adjacent second row of angled struts.

[0432] The features described herein with respect to any example may be combined with other features described in one or more of the other examples, unless otherwise noted. For example, any one or more of the features of one frame for a prosthetic heart valve may be combined with one or more features of another frame for a prosthetic heart valve.

[0433] Given the many possible examples to which the principles of the disclosed technology may be applied, it should be recognized that the examples presented are only preferred examples of the disclosed technology and should not be construed as limiting the scope of the claimed subject matter. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

[1] A heart valve prosthesis comprising: a radially expandable and compressible annular frame (400; 500) with: a plurality of interconnected struts defining a plurality of rows of cells disposed between an inflow end (408; 508) and an outflow end (406; 506) of the frame, wherein the plurality of interconnected struts comprises a plurality of outflow struts (460; 560) defining the outflow end (406; 506) and a plurality of inflow struts (462; 562) defining the inflow end (408; 508), wherein each outflow strut (460; 560) comprises two angled strut sections (410; 510) interconnected by a tip region (404; 502), and / or wherein each inflow strut (462; 562) comprises two angled strut sections (410; 510) interconnected by a tip region (404; 502), wherein each tip region (402; 404; 502) curves between a corresponding pair of two angled strut sections (410; 510), wherein each tip region (404; 502) has a reduced width (416) and a length that extends over at least 25% of a total length (425) of the outflow strut (460; 560) or the inflow strut (462; 562), and wherein the reduced width (416) is smaller than a width (418) of the two angled strut sections (410; 510). [2] The heart valve prosthesis of claim 1, wherein each tip region (404; 502) forms an angle (440) between the two angled strut sections (410; 510) of a corresponding outflow strut (460; 560) and / or inflow strut (462; 562) that is greater than 120 degrees and up to 140 degrees. [3] The heart valve prosthesis of claim 1 or 2, wherein each tip region (404; 502) comprises a curved outer surface having a radius of curvature of more than 1 mm, the curved outer surface extending between the outer surfaces of the two angled strut sections (410; 510) of a corresponding outflow strut (460; 560) and / or inflow strut (462; 562). [4] The heart valve prosthesis according to any one of claims 1 to 3, wherein the length of each tip region (402, 404; 502) is in a range of 0.9 mm to 2.2 mm. [5] The heart valve prosthesis according to any one of claims 1 to 3, wherein the length of each tip region (402, 404; 502) is in a range of 1.9 mm to 2.2 mm. [6] The heart valve prosthesis according to any one of claims 1 to 3, wherein the length of each tip region (402, 404; 502) at the outflow end (406; 506) is in a range of 1.8 mm to 2.4 mm, and wherein the length of each tip region (404; 502) at the inflow end (408; 508) is in a range of 0.8 mm to 1.2 mm. [7] The heart valve prosthesis according to any one of claims 1 to 6, wherein the reduced width (416) of each tip region (404; 502) is 0.06 mm to 0.15 mm smaller than the width (418) of the two angled strut sections (410; 510). [8] The heart valve prosthesis of any one of claims 1 to 7, further comprising a plurality of valve leaflets (204) attached to the frame (400; 500) and a plurality of commissure windows (520) formed by struts of the plurality of interconnected struts forming cells of a first row of cells (324) of the plurality of rows of cells, the first row of cells (324) being disposed at the outflow end (406; 506) of the frame, and each commissure window (242; 520) being configured to receive commissure tabs from two adjacent valve leaflets (204) of the plurality of valve leaflets (204). [9] The heart valve prosthesis of claim 8, wherein each commissure window (520) is defined by axially extending window strut portions (514) forming an upper end portion (516) above the commissure window and a lower end portion (518) below the commissure window (520), and wherein a length (528) of the upper end portion (516) and the lower end portion (518) in an axial direction relative to a central longitudinal axis of the frame is greater than the width of the two angled strut portions (410). [10] The heart valve prosthesis of claim 9, wherein the upper end portion (1616) includes a concave region (1620) disposed therein that is adjacent to a convex curve (1634) at a base of a first angled strut portion (1602a) of the two angled strut portions (410; 510) to which the upper end portion (1616) is connected, and wherein the convex curve (1636) extends from a concave curve (1634) in the first angled strut portion (1602a). [11] A heart valve prosthesis comprising: a radially expandable and compressible annular frame (400; 500) with: a plurality of interconnected struts defining a plurality of rows of cells disposed between a first end and a second end of the frame, the plurality of interconnected struts comprising a plurality of first struts defining the first end and a plurality of second struts defining the second end, each first strut comprising two angled strut sections (410; 510) interconnected by a tip region (404; 502), wherein the tip region (404; 502) curves between the two angled strut sections (410; 510) and has a reduced width (416) relative to a width of the two angled strut sections (410; 510), and wherein the tip region (404; 502) forms an angle (320) between the two angled strut sections (410; 510) that is greater than 120 degrees. [12] The heart valve prosthesis of claim 11, wherein the angle (320) is greater than 120 degrees and up to 140 degrees. [13] The heart valve prosthesis of claim 11 or 12, wherein the tip region (404; 502) comprises a curved, axially facing outer surface (428) continuous with the axially facing outer surfaces of the two angled strut sections (410; 510) and an axially facing inner recess (430), the inner recess (430) being recessed from the axially facing inner surfaces of the two angled strut sections (410; 510) towards the curved outer surface (428). [14] The heart valve prosthesis of any one of claims 11 to 13, wherein each second strut comprises two angled strut sections (410; 510) connected by a tip region (404; 502) that curves between the two angled strut sections (410; 510) and has a reduced width (416) relative to a width of the two angled strut sections (410; 510), the tip region (404; 502) forming an angle (320) between the two angled strut sections (410; 510) that is greater than 120 degrees, and the first end is an outflow end (406; 506) of the frame (400; 500) and the second end is an inflow end (408; 508) of the frame (400; 500). [15] The heart valve prosthesis of claim 14, wherein each first strut forms an outflow edge of a cell of a first row of cells arranged at the outflow end (406; 506) of the frame (400; 500), wherein each second strut forms an inflow edge of a cell of a second row of cells arranged at the inflow end (408; 508) of the frame (400; 500), and wherein the cell of the first row of cells has a greater axial length with respect to a central longitudinal axis of the frame than the cell of the second row of cells. [16] The heart valve prosthesis of claim 15, wherein the plurality of interconnected struts further comprises a plurality of axial struts (232) extending in a direction of the central longitudinal axis and spaced apart from each other about a circumference of the frame (400; 500), each axial strut (232) forming an axial side of two adjacent cells of the first row of cells (324), and each axial strut (232) having a width (244) greater than a width (416) of angled struts (410; 510) of the plurality of interconnected struts. [17] The heart valve prosthesis of any one of claims 11 to 16, further comprising a plurality of valve leaflets (204) attached to the frame (400; 500), and further comprising a plurality of commissure windows (242) formed by struts of the plurality of interconnected struts forming cells of a first row of cells (324) of the plurality of rows of cells, the first row of cells (324) being disposed at the first end of the frame, and each commissure window (242) being configured to receive commissure tabs from two adjacent valve leaflets (204) of the plurality of valve leaflets (204). [18] A heart valve prosthesis according to claim 17, wherein each commissure window (242) is defined by axially extending window strut portions (370a, 370b) forming an upper end portion (372) above the commissure window (242) and a lower end portion (374) below the commissure window (242), and wherein the upper end portion (372) includes two openings (376) disposed therein. [19] A heart valve prosthesis comprising: a radially expandable and compressible annular frame (400; 500) comprising: a plurality of interconnected struts defining a plurality of rows of cells disposed between a first end and a second end of the frame, the plurality of interconnected struts comprising a plurality of first struts defining the first end and a plurality of second struts defining the second end, each of the first struts and / or the second struts comprising: two angled strut sections (410; 510); and a tip region (404; 502) disposed between the two angled strut sections (410; 510), the tip region (404; 502) curving between the two angled strut sections (410; 510) and having a reduced width (416) relative to the width of the two angled strut sections (410; 510); and a cover member (1100) wrapped around and covering the tip portion (404; 502) of the plurality of first struts or the tip portion (404, 502) of the plurality of second struts of the frame (400; 500). [20] The heart valve prosthesis of claim 19, wherein the cover member (1100) comprises a plurality of successive loops (1102) of a strip or band of material. [21] The heart valve prosthesis of claim 20, wherein the tip region (404; 502) of the frame (400; 500) comprises a tip (502) and two narrow strut portions (414) extending outwardly from the tip (520) in opposite directions, wherein a width (416) of the two narrow strut portions (414) is narrower than a width (418) of the two angled strut portions (410; 510), wherein the tip region (404; 502) has shoulders (540) on both sides of the tip region that transition from the narrower of the two narrow strut portions (414) of the tip region (404; 502) to the wider of the two angled strut portions (410; 510), and wherein the plurality of consecutive loops (1002) of the strip or band of material wrapped around the two narrow strut sections (414) between the shoulders (540) of the tip region (404; 502). [22] The heart valve prosthesis of any one of claims 19 to 21, wherein the first end is an inflow end (408; 508) of the frame (400; 500) and wherein each tip region (404; 502) forms an angle (440) between the two angled strut portions (410; 510) of a corresponding first strut that is greater than 120 degrees and up to 140 degrees. [23] The heart valve prosthesis of any one of claims 19 to 22, further comprising an outer skirt (602) disposed around an outer surface (620) of the frame (400; 500), and wherein the cover member (1100) extends through the outer skirt (602) such that the outer skirt (602) is secured to the frame (400; 500).

Images