Prosthetic heart valve

Abstract

A prosthetic heart valve can include a frame with inflow and outflow ends, outflow struts defining the outflow end, and inflow struts defining the inflow end. At least one inflow strut or one outflow strut includes two angled strut portions interconnected by an apex region. The apex region can have a narrowed width smaller than a width of the two angled strut portions. In some examples, the apex region can have a length in a range from 3% to 10% of a total length of the outflow strut or the inflow strut. In some examples, the apex region can include a notch. In some examples, the apex region can define an arc length in a range from approximately 0.25 millimeters to approximately 0.85 millimeters, wherein the apex region can have a constant width along the arc length.

Description

PROSTHETIC HEART VALVECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U. S. Provisional Patent Application No.63 / 717,029, filed on November 6, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to prosthetic heart valves, and in particular to radially expandable and compressible frames for prosthetic heart valves.BACKGROUND

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

[0004] Described herein are prosthetic heart valves and frames for prosthetic heart valves. The disclosed prosthetic heart valves and frames can, for example, provide for improved expansion during deployment. As such, the devices disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves.

[0005] In some examples, a prosthetic heart valve can include a radially expandable and compressible annular frame.

[0006] In some examples, the frame can include an inflow end and an outflow end.

[0007] In some examples, the frame can include a plurality of interconnected struts.

[0008] In some examples, the plurality of interconnected struts can define a plurality of rows of cells arranged between the inflow end and the outflow end of the frame.

[0009] In some examples, the plurality of interconnected struts can include a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end.

[0010] In some examples, at least one inflow strut or at least one outflow strut can include an apex region curving between a corresponding pair of two angled strut portions.

[0011] In some examples, the apex region can have a narrowed width smaller than a width of the two angled strut portions.

[0012] In some examples, the apex region can have a length in a range from 3% to 40% of a total length of the outflow strut or the inflow strut.

[0013] In some examples, the apex region can have a length in a range from 3% to 10% of a total length of the outflow strut or the inflow strut.

[0014] In some examples, the apex region can have a length in a range from 6% to 30% of a total length of the outflow strut or the inflow strut.

[0015] some examples, the apex region can have a length in a range from 8% to 25% of a total length of the outflow strut or the inflow strut.

[0016] In some examples, the apex region can include at least one thinned strut portion connecting the two angled strut portions.

[0017] In some examples, the at least one thinned strut portion can include an inner surface defining an inner radius of curvature and an outer surface defining and outer radius of curvature, and the outer surface can be closer than the inner surface to an apex of the apex region.

[0018] In some examples, the inner radius of curvature and the outer radius of curvature can be concentric along a length of the at least one thinned strut portion.

[0019] In some examples, the inner radius of curvature and the outer radius of curvature are not concentric along a length of the at least one thinned strut portion.

[0020] In some examples, the apex region can include a notch.

[0021] In some examples, the prosthetic heart valve can further include a plurality of leaflets mounted on an inside of the annular frame.

[0022] In some examples, the apex region can include a head.

[0023] In some examples, the head can have an elliptical cross-section.

[0024] Example 20. The prosthetic heart valve of any example herein, particularly any one of Examples 17-19, wherein the head can have a flat radially outwards-facing side.

[0025] In some examples, the apex region can define an arc length along which the apex region has a constant width.

[0026] In some examples, the arc length can be in a range from approximately 0.25 millimeters to approximately 0.85 millimeters.

[0027] In some examples, the arc length can be in a range from approximately 0.25 millimeters to approximately 0.35 millimeters.

[0028] In some examples, the arc length can be in a range from approximately 0.4 millimeters to approximately 0.5 millimeters.

[0029] In some examples, the arc length can be in a range from approximately 0.7 millimeters to approximately 0.85 millimeters.

[0030] In some examples, a prosthetic heart valve can include a radially expandable and compressible annular frame and a plurality of leaflets mounted on an inside of the annular frame. The frame can include an inflow end, an outflow end, and a plurality of interconnected struts defining a plurality of rows of cells arranged between the inflow end and the outflow end of the frame. The plurality of interconnected struts can include a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. At least one inflow strut or at least one outflow strut can include an apex region curving between a corresponding pair of two angled strut portions. The apex region can have a narrowed width smaller than a width of the two angled strut portions. The apex region can have a length in a range from 3% to 10% of a total length of the outflow strut or the inflow strut.

[0031] In some examples, a prosthetic heart valve can include a radially expandable and compressible annular frame and a plurality of leaflets mounted on an inside of the annular frame. The annular frame can include an inflow end, an outflow end, and a plurality of interconnected struts defining a plurality of rows of cells arranged between the inflow end and the outflow end of the frame. The plurality of interconnected struts can include a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. At least one inflow strut or at least one outflow strut can include an apex region curving between a corresponding pair of two angled strut portions. The apex region can include a notch.

[0032] In some examples, a prosthetic heart valve can include a radially expandable and compressible annular frame and a plurality of leaflets mounted on an inside of the annular frame. The annular frame can include an inflow end, an outflow end, and a plurality of interconnected stmts defining a plurality of rows of cells arranged between the inflow end and the outflow end of the frame. The plurality of interconnected struts can include a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. At least one inflow strut or at least one outflow strut can include an apex region curving between a corresponding pair of two angled strut portions. The apex region can include a head having an elliptical cross-section coupled to each of the two angled stmt portions.

[0033] In some examples, a prosthetic heart valve can include a radially expandable and compressible annular frame and a plurality of leaflets mounted on an inside of the annular frame. The radially expandable and compressible annular frame can include an inflow end, an outflow end, and a plurality of interconnected stmts defining a plurality of rows of cells arranged between the inflow end and the outflow end of the frame. The plurality of interconnected struts can include a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. At least one inflow strut or at least one outflow strut can include an apex region curving between a corresponding pair of two angled strut portions. The apex region can define an arc length along which the apex region has a constant width. The arc length can be in a range from approximately 0.25 millimeters to approximately 0.85 millimeters.

[0034] In some examples, a prosthetic valve can include a radially expandable and compressible annular frame and a plurality of leaflets mounted on an inside of the annular frame. The frame can include an inflow end, an outflow end, and a plurality ofinterconnected struts defining a plurality of rows of cells arranged between the inflow end and the outflow end of the frame. The plurality of interconnected struts can include a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. At least one inflow strut or at least one outflow strut can include an apex region curving between a corresponding pair of two angled strut portions. The apex region can include at least one thinned strut portion defining an inner radius of curvature and an outer radius of curvature, wherein the inner radius of curvature and the outer radius of curvature can be non-concentric.

[0035] In some examples, a prosthetic heart valve comprises one or more of the components recited in Examples 1-38 below.

[0036] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0037] FIG. 1 is a side view of a prosthetic heart valve, according to an example.

[0038] FIG. 2 is a side view of a frame of the prosthetic heart valve of FIG. 1.

[0039] FIG. 3 is a side view of a portion of the frame of FIG. 2, showing the portion of the frame in a straightened (non-annular) state.

[0040] FIG. 4 is a side view of a prosthetic heart valve delivery apparatus, according to an example.

[0041] FIG. 5A is a side view of a portion of a strut of a prosthetic heart valve frame, according to an example.

[0042] FIG. 5B is a side view of a portion of a strut of a prosthetic heart valve frame, according to an example.

[0043] FIG. 6 is a side view of a portion of a strut of a prosthetic heart valve frame, according to an example.

[0044] FIG. 7 is a side view of an outflow portion of a prosthetic heart valve, according to an example.

[0045] FIG. 8 is a side view of a portion of a strut of a prosthetic heart valve frame, according to an example.

[0046] FIG. 9A is a side view of a portion of an outflow strut of a prosthetic heart valve frame, according to an example.

[0047] FIG. 9B is a side view of a portion of an inflow strut of a prosthetic heart valve frame, according to an example.

[0048] FIG. 10 is a side view of a portion of a frame for a prosthetic heart valve, according to an example.

[0049] FIG. 11 is a side view of a portion of a strut of a prosthetic heart valve frame, according to an example.DETAILED DESCRIPTIONGeneral Considerations

[0050] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0051] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations thatcorrespond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0052] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0053] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0054] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Examples of the Disclosed Technology

[0055] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state during delivery, and then expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0056] FIG. 1 shows a prosthetic heart valve 100 (which is also referred to herein as a “prosthetic valve”), according to one example. The prosthetic heart valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vesselscommunicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0057] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U. S. Publication No. 2017 / 0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U. S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0058] The prosthetic heart valve 100 can include a stent or frame 102, a valvular structure 104, and a perivalvular outer sealing member or outer skirt 106. The prosthetic heart valve 100 (and the frame 102) can have an inflow end 108 and an outflow end 110. The valvular structure 104 can be disposed on an interior of the frame 102 while the outer skirt 106 is disposed around an outer surface of the frame 102.

[0059] The valvular structure 104 can comprise a plurality of leaflets 112 (for example, three leaflets), collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement. The leaflets 112 can be secured to one another at their adjacent sides (for example, commissure tabs) to form commissures 114 of the valvular structure 104. For example, each leaflet 112 can comprise opposing commissure tabs disposed on opposite sides of the leaflet 112 and a cusp edge portion extending between the opposing commissure tabs. The cusp edge portion of the leaflets 112 can have an undulating, curved scalloped shape, and can be secured directly to the frame 102 (for example, by sutures). However, in alternate examples, the cusp edge portion of the leaflets 112 can be secured to an inner skirt which is then secured to the frame 102. In some examples, the leaflets 112 can be formed ofpericardial tissue (for example, bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U. S. Patent No. 6,730,118, which is incorporated by reference herein.

[0060] In some examples, the outer skirt 106 can be an annular skirt. In some instances, the outer skirt 106 can comprise one or more skirt portions that are connected together and / or individually connected to the frame 102. The outer skirt 106 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the outer skirt 106 can comprise a fabric having interlaced yams or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the outer skirt 106 can comprise a fabric without interlaced yarns or fibers or randomly interlaced yams or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the outer skirt 106 can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the outer skirt 106 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the outer skirt 106 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources). Other examples of outer skirts that can be used with the frame 102 can be found in PCT Publication No. WO 2023 / 244612, filed on June 13, 2023, which is incorporated by reference herein.

[0061] The frame 102 can be radially compressible and expandable between a radially compressed (or collapsed) configuration and a radially expanded configuration (the expanded configuration is shown in FIG. 1). The frame 102 is shown alone in FIG. 2 and a portion of the frame 102 in a straightened (non-annular) configuration is shown in FIG. 3.

[0062] The frame 102 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol). When constructed of a plastically -expandable material, the frame 102 (and thus the prosthetic heart valve 100) can be crimped to a radially compressed state on a deliverycatheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 102 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0063] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 102) include metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 102 can comprise stainless steel. In some examples, the frame 102 can comprise cobalt-chromium. In some examples, the frame 102 can comprise nickel-cobalt-chromium. In some examples, the frame 102 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0064] As shown in FIGS. 2 and 3, the frame 102 can comprise a plurality of interconnected struts 116 which form multiple rows of open cells 118 between the outflow end 110 and the inflow end 108 of the frame 102. In some examples, as shown in FIGS. 2 and 3, the frame 102 can comprise three rows of cells 118 with a first (upper in the orientation shown in FIGS.2 and 3) row 120 of cells disposed at the outflow end 110. The first row 120 of cells comprises cells 118 that are elongated in an axial direction (relative to a central longitudinal axis 122 of the frame 102), as compared to cells 118 in the remaining rows of cells. For example, the cells 118 of the first row 120 of cells can have a longer axial length 124 (FIG. 3) than cells 118 in the remaining rows of cells, which can include a second row 126 of cells and a third row 128 of cells, the third row 128 of cells disposed at the inflow end 108 and the second row 126 of cells disposed between the first row 120 of cells and the third row 128 of cells.

[0065] In some examples, as shown in FIG. 2, each row of cells comprises nine cells 118. Thus, in such examples, the frame 102 can be referred to as a “nine-cell frame.”

[0066] In alternate examples, the frame 102 can comprise more than three rows of cells (for example, four or five rows of cells) and / or more or less than nine cells per row. In someexamples, the cells 118 in the first row 120 of cells may not be elongated compared to cells 118 in the remaining rows of cells of the frame 102 (the second row 126 of cells and the third row 128 of cells).

[0067] The interconnected struts 116 can include a plurality of angled struts 130, 132, 134, and 136 arranged in a plurality of rows of circumferentially extending rows of angled struts, with the rows being arrayed along the length of the frame 102 between the outflow end 110 and the inflow end 108. For example, the frame 102 can comprise a first row of angled stmts 130 (which are also referred to herein as “inflow stmts”) arranged end-to-end and extending circumferentially at the inflow end 108 of the frame; a second row of circumferentially extending, angled struts 132; a third row of circumferentially extending, angled struts 134; and a fourth row of circumferentially extending, angled struts 436 at the outflow end 110 of the frame 102. The fourth row of angled stmts 136 (which are also referred to herein as “outflow stmts”) can be connected to the third row of angled struts 134 by a plurality of axially extending window struts 138 (or window strut portions) and a plurality of axial (or axially extending) struts 140. The axially extending window struts 138 (which can also be referred to as axial struts that include a commissure window) define commissure windows (for example, open windows) 142 that are spaced apart from one another around the frame 102, in a circumferential direction, and which are adapted to receive a pair of commissure tabs of a pair of adjacent leaflets 112 arranged into a commissure (for example, commissure 114 shown in FIG. 1). In some examples, the commissure windows 142 and / or the axially extending window stmts 138 defining the commissure windows 142 can be referred to herein as commissure features or commissure supports, each commissure feature or support configured to receive and / or be secured to a pair of commissure tabs of a pair of adjacent leaflets.

[0068] Each inflow strut 130 can include a pair of angled strut portions 131. The pair of angled strut portions 131 can be connected by an apex region 152, which forms a junction between the two angled strut portions 131. As such, the apex regions 152 can be spaced apart from one another in a circumferential direction at the inflow end 108.

[0069] Each apex region 152 can include a corresponding apex 154 (the most outward extending point in an axial direction) and two thinned (or narrowed) strut portions 156. For the inflow stmts 130, the apex 154 can be the most outward extending point of the frame 102 in an inflow direction. One thinned strut portion 156 can extend from either side of the apex 154 to a corresponding one of the wider angled strut portion 131. The angled stmt portions131 can also be referred to herein as “widened strut portions” to distinguish them from the thinned stmt portions 156. In this way, each of the apex regions 152 at the inflow end 108 can form a narrowed transition region between and relative to the two angled strut portions 131 extending from the corresponding apex region 152. The apex region 152 can form an angle 180 (which is also referred to herein as an “apex angle”) between the two angled strut portions 131 extending from either side of the corresponding apex region 152. Each outflow strut 136 has an overall length 160 that extends from a first location at a junction with a commissure strut 138 or an axial strut 140 to a second location at next closest junction with a commissure strut 138 or an axial strut 140.

[0070] Similarly, each outflow strut 136 can include the pair of angled strut portions 131 connected by the apex region 152. The apex regions 152 of the outflow struts 136 can be spaced apart from one another in a circumferential direction at the outflow end 110. The apex regions of the outflow struts 136 can define apices 154 that are the most outward extending points in the outflow direction. The apex regions 152 of the outflow struts 136 can include thinned strut portions 156 extending from each side of the apices 154 and can define apex angles 180.

[0071] One or more (for example, two, as shown in FIGS. 2 and 3) axial stmts 140 can be positioned between, in the circumferential direction, two commissure windows 142 formed by the window stmts 138. Since the frame 102 can include fewer cells per row (for example, nine) and fewer axial struts 140 between each commissure window 142, as compared to some more traditional prosthetic heart valves, each cell 118 can have an increased width (in the circumferential direction), thereby providing a larger opening for blood flow and / or coronary access.

[0072] Each axial strut 140 and each window strut 138 extends from a location defined by the convergence of the lower ends (for example, ends arranged inward of and farthest away from the outflow end 110) of two angled struts 136 (which can also be referred to as an upper strut junction or upper elongated strut junction) to another location defined by the convergence of the upper ends (for example, ends arranged closer to the outflow end 110) of two angled struts 134 (which can also be referred to as a lower strut junction or lower elongate strut junction). Each axial strut 140 and each window strut 138 forms an axial side of two adjacent cells of the first row 120 of cells.

[0073] Commissure tabs 115 of adjacent leaflets 112 can be secured together to form commissures 114 (FIG. 1). Each commissure 114 of the prosthetic heart valve 100 comprises two commissure tabs 115 paired together, one from each of two adjacent leaflets 112, and extending through a commissure window 142 of the frame 102. Each commissure 114 can be secured to the window struts 138 forming the commissure window 142.

[0074] The cusp edge portion (for example, scallop edge) of each leaflet 112 can be secured to the frame 102 via one or more fasteners (for example, sutures). In some examples, the cusp edge portion of each leaflet 112 can be secured directly to the struts of the frame 102 (for example, angled struts 130, 132, and 134). For example, the cusp edge portions of the leaflets 112 can be sutured to the angled struts 130, 132, and 134 that generally follow the contour of the cusp edge portions of the leaflets 112.

[0075] In some examples, the cusp edge portion of the leaflets 112 can be secured to an inner skirt and the inner skirt can then be secured directly to the frame 102.

[0076] Various methods for securing the leaflets 112 to a frame, such as the frame 102, are disclosed in PCT Publication WO 2023 / 086548, which is incorporated by reference herein in its entirety.

[0077] FIG. 5A is a side view of an end portion of a prosthetic heart valve frame (which is also referred to herein as a “frame”), according to an example. The frame includes a plurality of inflow struts defining an inflow end of the frame and a plurality of outflow struts defining an outflow end of the frame. FIG. 5A illustrates a portion of an exemplary strut 336 at an axial end of the frame, wherein the stmt 336 is depicted in the radially compressed state of the frame. In some examples, the exemplary strut 336 can be one or more of the plurality of outflow struts at the outflow end of the frame. In some examples, each one of the plurality of outflow struts can have the same structure as the strut 336. In some examples, the exemplary strut 336 can additionally or alternatively be one or more of the plurality of inflow struts at the inflow end of the frame. In some examples, each one of the plurality of inflow struts can have the same structure as the strut 336. In some examples, the frame 102 can include an outflow row of struts 336 defining the outflow end (similar to outflow end 110) of the frame and / or a row of inflow row of struts 336 defining the inflow end (similar to inflow end 108) of the frame.

[0078] The stmt 336 includes a pair of angled stmt portions 331 (which are also referred to herein as “widened stmt portions”) connected by an apex region 352, which curves betweenthe angled stmt portions 331 to form a junction between the two angled strut portions 331. The apex region 352 defines an apex 354 and two thinned strut portions 356, delineated in dashed lines, extending from the sides of the apex 354. The apex region 352 further defines two transition portions 358 (which are also referred to herein as “intermediate portions,” “shoulder portions” or “shoulders”), also delineated in dashed lines, wherein each of the transition portions 358 connects one of the thinned strut portions 356 and a corresponding one of the widened strut portions 331.

[0079] Each widened strut portion 331 has a length (which extends from a corresponding transition portion 358 to a junction with a commissure strut 138 or an axial strut 140) between its end portions, each thinned strut portion 356 has a length 362 extending between its end portions, and each transition portion 358 has a length 364 extending between its end portions. A length of the apex region 352 is the sum of the lengths 362, 364 of the two thinned strut portions 356 and the two transition portions 358. A length 160 (shown in FIG.3, which is also referred to herein as a “total length” or “overall length”) of the stmt 336 is the sum of the lengths of the two widened stmt portions 331, the lengths 362 of the two thinned stmt portions 356, and the lengths 364 of the two transition portions 358. The length 160 of the stmt 336 extends from the end of one of the widened stmts 331 where it intersects a junction with a stmt 138 or stmt 140 to the end of the other widened stmt 331 where it intersects a junction with a stmt 138 or stmt 140.

[0080] The apex region 352 has a length in a range from 3% to 40% of the length 160 of the outflow stmt 336. For example, the apex region 352 can have a length in a range from 3% to 5%, from 5% to 6%, from 6% to 8%, from 8% to 10%, from 10% to 15%, from 15% to 20%, from 20% to 25%, from 25% to 30%, from 30% to 35%, or from 35% to 40% of the length of the outflow stmt 336.

[0081] In some examples, for a frame 102 having an expanded diameter of 23 mm, the apex region 352 can have a length in a range from 6% to 30% of the length 160 of the outflow strut 336. For example, the apex region 352 can have a length in a range from 6% to 10%, from 10% to 15%, from 15% to 20%, from 20% to 25%, or from 25% to 30%, of the length of the outflow strut 336.

[0082] In some examples, for a frame 102 having an expanded diameter of 29 mm, the apex region 352 can have a length in a range from 8% to 25% of the length 160 of the outflow strut336. For example, the apex region 352 can have a length in a range from 8% to 12%, from 12% to 17%, from 17% to 22%, or from 22% to 25% of the length of the outflow strut 336.

[0083] In some examples, the apex region 352 can have a length in a range from 3% to 10% (for example, from 3% to 5%, from 5% to 6%, from 6% to 8%, and / or from 8% to 10%) of the length 160 of the outflow strut 336. In this way, the length of the apex region 352 can be configured to influence the stress concentration at the apex region 352, thereby better distributing stresses along the rows of struts comprised of the struts 336 (for example, one or more of the inflow and outflow rows of struts of the frame) during crimping and expansion to achieve more uniform radial compression and / or expansion of the frame.

[0084] The apex region 352 can have a length in a range from 20% to 40% of the length 160 of the outflow stmt 336. For example, the apex region 352 can have a length in a range from 20% to 25%, from 25% to 30%, from 30% to 35%, or from 35% to 40%, of the length 160 of the outflow stmt 336. Elongating the apex region 352 can be advantageous in that it increases the area below the apex region 352 and the upper edges of the leaflets 112 for passing a coronary catheter through the frame below the apex region 352 for accessing a coronary artery.

[0085] The strut 336 defines a first side surface 366 and a second side surface 368, wherein the first side surface 366 is closer to the center of curvature of the apex region than the second side surface 368. Each widened stmt portion 331 defines a width 370 extending between the first side surface 366 and the second side surface 368, each thinned stmt portion 356 defines a width 372 extending between the first side surface 366 and the second side surface 368, and each transition portion define a width 374 extending between the first side surface 366 and the second side surface 368. As shown, the width 370 of the widened strut portions 331 is greater than each of the widths 372, 374 of the thinned strut portions 356 and the transition portions 358. Thus, the apex region 352 has a maximum width smaller than the width 370 of the two angled strut portions 331. As further shown, the width 370 of the widened strut portion 331 is constant along its length. As further shown, the width 372 of the thinned strut portion 356 is constant along its length 362. As further shown, the width 374 of the transition portion 358 increases along its length 364 from the width 372 of the thinned strut portion 356 to the greater width 370 of the widened strut portion 331.

[0086] As used herein, a “width” of a stmt is measured between opposing locations on opposing surfaces of a stmt, wherein each of the opposing surfaces extends from a radiallyinwardly-facing surface of the strut to an radially outwardly-facing surface of the strut. For example, the width of a strut 336 is measured from a side surface 366 to a side surface 368 of the strut 336. The width of a strut is perpendicular to a thickness of a strut, which is measured along a line that extends from a first location on a radially inwardly facing surface of the strut to a second location on a radially outwardly facing surface of the strut in a radial direction of the frame.

[0087] As shown, when the frame is crimped to a radially compressed state, the strut 336 is bent such that the apex region 352 curves between the widened strut portions 331. When the frame is in the radially compressed state, the inner surface 366 defines an inner radius of curvature 376 and the outer surface 368 defines an outer radius of curvature 378. As shown, the inner radius of curvature 376 and the outer radius of curvature 378 are concentric along the thinned strut portions 356. As further shown, the inner radius of curvature 376 and the outer radius of curvature 378 are not concentric along the transition portions 358. As further shown, the inner radius of curvature 376 and the outer radius of curvature 378 are equal (for example, infinite) along the widened strut portions 331.

[0088] FIG. 5B is a side view of an end portion of a prosthetic heart valve frame, according to an example. The frame includes a plurality of inflow struts defining an inflow end of the frame and a plurality of outflow struts defining an outflow end of the frame. FIG. 5B illustrates a portion of an exemplary strut 436 at an axial end of the frame, wherein the stmt 436 is depicted in the radially compressed state of the frame. In some examples, the exemplary strut 436 can be one or more of the plurality of outflow struts at the outflow end of the frame. In some examples, each one of the plurality of outflow struts can have the same structure as the strut 436. In some examples, the exemplary strut 436 can additionally or alternatively be one or more of the plurality of inflow struts at the inflow end of the frame. In some examples, each one of the plurality of inflow struts can have the same structure as the strut 436. In some examples, the frame 102 can include an outflow row of the struts 436 defining the outflow end (similar to outflow end 110) of the frame and / or a row of inflow row of the struts 436 defining the inflow end (similar to inflow end 108) of the frame.

[0089] The stmt 436 includes a pair of angled stmt portions 431 (which are also referred to herein as “widened stmt portions”) connected by an apex region 452, which curves between the widened stmt portions 431 to form a junction between the two widened stmt portions 431. The apex region 452 defines an apex 454 and two thinned stmt portions 456 extending from the sides of the apex 454. The apex region 452 further defines two constant- width transitionportions 480 extending from the thinned strut portions 456 and two varying-width transition portions 458 extending from the intermediate constant-width portions 480 and connecting to ends of the widened strut portions 431. Thus, one exemplary difference between the strut 436 and the strut 336 of FIG. 5A is that the strut 436 includes both constant-width transition portions 480 and varying-width transition portions 458.

[0090] Each widened strut portion 431 includes a length (which extends from a corresponding transition portion 458 to a junction with a commissure strut 138 or an axial strut 140) and a width 470 that is constant along the length. Each thinned strut portion 456 includes a length 462 and a width 472 that varies along its length 462. Each varying-width transition portion 458 includes a length 464 and a width 474 that varies along its length 464. Each constant-width transition portion 480 includes a length 482 and a width 484 that is constant along its length 482.

[0091] A total or overall length 160 of the strut 436 is the sum of the lengths of the two widened strut portions 431, the lengths 462 of the two thinned strut portions 456, the lengths 464 of the two varying-width transition portions 458, and the lengths 482 of the two constant-width transition portions 480. A length of the apex region 452 is the sum of the lengths 462, 464, and 482 of the two thinned strut portions 356, the two varying-width transition portions 458, and the two constant-width transition portions 480.

[0092] In some examples, the apex region 452 can have a length in a range from 3% to 40% of the length 160 of the outflow strut 436. For example, the apex region 452 can have a length in a range from 3% to 5%, from 5% to 6%, from 6% to 8%, from 8% to 10%, from 10% to 15%, from 15% to 20%, from 20% to 25%, from 25% to 30%, from 30% to 35%, or from 35% to 40% of the length 160 of the outflow strut 436. In some examples, the frame can have a 23-millimeter nominal diameter and the apex region 452 of the frame can have a length in a range 6% to 30% of the overall length 160 of the outflow strut 436, for example, in a range from 6% to 8%, from 8% to 10%, from 10% to 15%, from 15% to 20%, from 20% to 25%, or from 25% to 30%. In some examples, the frame can have a 29-millimeter nominal diameter and the apex region 452 of the frame can have a length in a range 8% to 25% of the overall length 160 of the outflow strut 436, for example, from 8% to 10%, from 10% to 15%, from 15% to 20%, or from 20% to 25%. In some examples, the apex region 452 can preferably have a length in a range from 3% to 10% (for example, from 3% to 5%, from 5% to 6%, from 6% to 8%, and / or from 8% to 10%) of the length 160 of the outflow strut 436.

[0093] The strut 436 defines a first side surface 466 having an inner radius of curvature 476 and a second side surface 468 having an outer radius of curvature 478, wherein the first side surface 466 is further from the apex 454 than the second side surface 468. One exemplary difference between the strut 436 and the strut 336 shown in FIG. 5A is that the inner and outer radii of curvature 476, 478 are not concentric along the length 462 of the thinned strut portions 456. In some examples, further thinning the inner portions of the thinned strut portions 456, such that the radii of curvature 476, 478 are no longer concentric, can help further concentrate stress at a point near the apex 454 and achieve more uniform radial compression and / or expansion of the frame.

[0094] FIG. 6 is a side view of an end portion of a prosthetic heart valve frame (which is also referred to herein as a “frame”), according to an example. The frame includes a plurality of inflow struts defining an inflow end of the frame and a plurality of outflow struts defining an outflow end of the frame. FIG. 6 illustrates a portion of an exemplary strut 536 at an axial end of the frame, wherein the stmt 536 is depicted in the radially compressed state of the frame. In some examples, the exemplary strut 536 can be one or more of the plurality of outflow struts at the outflow end of the frame. In some examples, each one of the plurality of outflow struts can have the same structure as the strut 536. In some examples, the exemplary strut 536 can additionally or alternatively be one or more of the plurality of inflow struts at the inflow end of the frame. In some examples, each one of the plurality of inflow struts can have the same structure as the strut 536. In some examples, the frame 102 can include an outflow row of the struts 536 defining an outflow end (similar to outflow end 110) of the frame and / or a row of inflow row of the struts 536 defining an inflow end (similar to inflow end 108) of the frame.

[0095] The strut 536 can share certain similar features with the strut 336 shown in FIG. 5A. One exemplary difference is that the strut 536 includes the pair of widened strut portions 331 connected by an apex region 552. One difference between the apex region 552 and the apex region 352 shown in FIG. 5A is that the apex region 552 includes a notch 586 (which is also referred to herein as a “slot”). The notch 586 is shown to have a “v”-shape but in some examples, the notch 586 can have other shapes (for example, a rectangular shape, an inverted “v”- or dovetail-shape, a semicircle, a semi-ellipse, etc.). As shown, the notch 586 extends from the inner surface 366 towards the outer surface 368. In some examples, the notch 586 can extend from the outer surface 368 towards the inner surface 366. As further shown, the notch 586 is aligned with the apex 354 in a circumferential direction of the frame, such thatthe notch 586 is equidistant between the widened strut portions 331 and / or the thinned strut portions 356. However, in some examples, the notch 586 can be disposed anywhere within the apex region 552. In some examples, the notch 586 can provide a narrow portion of the apex region 552 that helps better concentrate stresses at a particular point along the strut 536, for example, a point adjacent the notch 586 to achieve more uniform radial compression and / or expansion of the frame.

[0096] FIG. 7 is a side view of an outflow portion of a prosthetic heart valve frame, according to an example. The illustrated portion of the frame is a portion of an angled strut 636. In some examples, the angled strut 636 can be an “outflow strut” disposed at an outflow end of the frame. In some examples, the angled strut 636 can be in a plurality of angled stmts forming row of outflow stmts. In such examples, the angled stmt 636 can be coupled to two corresponding axial stmts 140 or a corresponding axially extending window strut 138 and a corresponding axial stmt 140. In some examples, the angled stmt 636 can be an “inflow stmt” disposed at an inflow end of the frame. In some examples, the angled stmt 636 can be disposed between the inflow and outflow ends of the frame. In some examples, the frame 102 can include an outflow row of the stmts 636 defining the outflow end (similar to outflow end 110) of the frame 102 and / or a row of inflow row of the stmts 636 defining the inflow end (similar to inflow end 108) of the frame 102.

[0097] The angled strut 636 can include a pair of angled strut portions 631 connected by an apex region 652. The apex region 652 of the angled strut 636 can be spaced apart from other apex regions of adjacent struts in a circumferential direction of the frame. The apex region 652 can define an apex 654 that is the most outwardly extending point of the angled stmt 636 in an axial direction (for example, an inflow direction for an inflow stmt or an outflow direction for an outflow stmt). As shown, the apex region 652 includes a head 688. In some examples, the head 688 can have an elliptical (for example, circular or oval) cross-section, such that the head 688 can have a maximum circumferential width 692 that is greater than an axial height 694.

[0098] The head 688 can be coupled to each of the two angled strut portions 631. As shown, the head 688 and the angled stmt portions 631 can be coupled at a junction 696. As further shown, the junction 696 includes a concave inner surface 698, for example, with a “u” or “v”-shape. The head 688 can define a second circumferential width 693 at the junction 696 where the angled stmt portions 631 intersect the head 688. The maximum circumferential width 692 can be greater than the second circumferential width 693 such that the headextends circumferentially in two directions (to the left and the right in FIG. 7) beyond the location where each strut portion 631 intersects the head 688.

[0099] In some examples, the head 688 can have a flat or substantially flat radially outwards-facing side. In some examples, the head 688 can have a radially outwards-facing side that protrudes in a radially outwards-facing direction of the frame. For example, the head 688 can have a three-dimensional (for example, spherical or ellipsoidal) shape. In some examples, the head 688 can provide the frame of the prosthetic heart valve with a curved, atraumatic surface.

[0100] FIG. 8 is a side view of one half of a strut 736 (for example, the left side of the strut in FIG. 8) of a prosthetic heart valve frame, according to an example, wherein the strut 736 is depicted in the radially compressed state of the frame. It should be understood that the full strut includes the left side (shown in FIG. 8) and a right side, which is a mirror image of the left side. The frame can comprise a plurality of inflow struts disposed at an inflow end of the frame and a plurality of outflow struts disposed at an outflow end of the frame. In some examples, the strut 736 can be at least one of the plurality of inflow struts. For example, each one of the plurality of inflow struts can be the strut 736. In some examples, the strut 736 can be at least one of the plurality of outflow struts. For example, each one of the plurality of outflow struts can be the strut 736. In some examples, the frame 102 can include an outflow row of struts 736 defining the outflow end 110 of the frame and / or a row of inflow row of struts 736 defining the inflow end 108 of the frame.

[0101] The stmt 736 includes a pair of angled stmt portions 731 (which are also referred to herein as “widened stmt portions”) connected by an apex region 752, which curves between the angled stmt portions 731 to form a junction therebetween. The apex region 752 defines an apex 754, two thinned stmt portions 756 extending from each side of the apex 754, and two transition portions 758 (which are also referred to herein as “intermediate portions,” “shoulder portions” and / or “shoulders”), each connecting one of the thinned stmt portions 756 and a corresponding one of the widened stmt portions 731. FIG. 8 shows only the left hand side of the stmt 736 on one side of the apex 754, so only one thinned stmt portion 756, one transition portion 758, and a portion of one widened stmt portion 731 are illustrated.

[0102] The widened strut portion 731 defines a width 770. The thinned strut portion 756 defines a length 762 and a width 772. In some examples, the length 762 can be approximately 0.15 millimeters (for example, ± 10%). In some examples, the sum of the two lengths 762 can define an arc length of the apex region 752. In such examples, the arc lengthcan be in a range from 0.25 millimeters to 0.35 millimeters, for example, approximately 0.30 millimeters (for example, ± 10%). The transition portion 758 defines a length 764 and a width 774.

[0103] The strut 736 includes an inner surface 766 defining an inner radius of curvature 776 and an outer surface 768 defining an outer radius of curvature 778. As shown, the inner radius of curvature 776 and the outer radius of curvature 778 are concentric along the length 762 of the thinned strut portion 756. Thus, the thinned stmt portion 756 can have a constant width 772. In some examples where the thinned stmt portion 756 has a constant width 772, the arc length can be the length along which the apex region 752 has concentric inner and outer radii of curvature 776, 778. As further shown, the inner radius of curvature 776 and the outer radius of curvature 778 are not concentric along the length 764 of the transition portion 758. Thus, the width 774 of the transition portion 758 is not constant along the length 764 of the transition portion 758. For example, as shown, the width 774 of the transition portion 758 can increase (for example, continuously increase) from the thinned stmt portion 756 to the widened stmt portion 731. In some examples, gradually increasing the width of the transition portion 758 can help better concentrate stress at the thinned stmt region 756 near the apex 754.

[0104] FIG. 9A is a side view of a portion of an outflow stmt 836 of a prosthetic heart valve frame, according to an example, wherein the stmt is depicted in the radially expanded state of the frame. The outflow stmt 836 includes two angled stmt portions 831 (which are also referred to herein as “widened stmt portions”) connected by an outflow apex region 852o. The outflow apex region 852o includes an apex 854, two thinned outflow stmt regions 856o extending from each side of the apex 854, and two transition regions 858, each connecting a corresponding widened stmt portion 831 with a corresponding thinned outflow stmt region 856o.

[0105] Each widened stmt portion 831 defines a width 870 between an inner surface 866 and an outer surface 868. In some examples, the width 870 can be constant along the length of the widened stmt portion 831.

[0106] Each thinned outflow stmt portion 856o defines a length 862o and a width 872. In some examples, the length 862o can be in a range from approximately 0.2 millimeters to approximately 0.25 millimeters, such as approximately 0.23 millimeters (for example, ± 10%). The sum of the lengths 862o of the two thinned outflow stmt portions 856o defines anarc length 890o of the outflow apex region 852o. Thus, in some examples, the arc length 890o can be in a range from approximately 0.4 millimeters to approximately 0.5 millimeters, such as approximately 0.46 millimeters (for example, ± 10%). In some examples, shortening the arc length 890o can better concentrate stress at the outflow apex region 852o. As shown, the width 872 of the thinned outflow strut portion 856o is constant; thus, the arc length 890o can be the length along which outflow apex region 852o has a constant width.

[0107] Each transition portion 858 of the outflow strut 836 can define a width 874. As shown, the width 874 can vary (for example, continuously vary) along the length of the transition portion 858.

[0108] FIG. 9B is a side view of a portion of an inflow strut 830 of a prosthetic heart valve frame, according to an example, wherein the strut is depicted in the radially expanded state of the frame. The inflow strut 830 includes an inflow apex region 852i connecting the widened strut portions 831. The inflow apex region 852i includes the apex 854, two thinned inflow strut regions 856i extending from each side of the apex 854, and two transition regions 858. One exemplary difference between the thinned inflow strut regions 856i and the thinned outflow strut regions 856o shown in FIG. 9A is that the thinned inflow strut regions 856i can each have a length 862i that is greater than the length 862o. For example, the length 862i can be in a range from approximately 0.35 millimeters to approximately 0.4 millimeters, such as approximately 0.39 millimeters (for example, ± 10%). Thus, the inflow apex region 852i can have an arc length 890i (equal to the sum of the lengths 862i of the two thinned inflow strut regions 856i) in a range from approximately 0.7 millimeters to approximately 0.85 millimeters, such as 0.78 millimeters (for example, ± 10%). In some examples, the arc lengths 890i, 890o can be equal. In some examples, the arc length 890o of the outflow apex region 852o can be larger than the arc length 890o of the inflow apex region 852i. In some examples, shortening the arc length 890i can better concentrate stress at the inflow apex region 852i.

[0109] In some examples, the frame 102 can include an outflow row of struts 836 defining the outflow end 110 of the frame and / or a row of inflow row of struts 830 defining the inflow end 108 of the frame.

[0110] FIG. 10 is a portion of a frame 902 of a prosthetic heart valve in a radially expanded state, according to an example. As shown, the frame 902 includes a first row of angled struts 930 arranged end-to-end and extending circumferentially at an inflow end 908 of the frame902, a second row of circumferentially extending, angled struts 932, a third row of circumferentially extending, angled struts 933, a fourth row of circumferentially extending, angled struts 934, and a fifth row of circumferentially extending, angled struts 936 at an outflow end 910 of the frame 902. The fourth and fifth rows of struts 934, 936 can be interconnected by commissure struts 938 and axial struts 940. FIG. 10 shows only one section of the frame 902; it should be understood that the complete frame includes a plurality of frame sections, such as nine or twelve frame sections.

[0111] As further shown, the lengths of each angled strut 930, 932, 933, 934, 936 in each circumferentially extending, row are equal or substantially equal (for example, ±10%). In other words, each angled strut 930, 932, 933, 934, 936 of the frame 902 has the same length. In some examples, configuring the lengths of all angled struts 930, 932, 933, 934, 936 to be equal can further stabilize the frame 902 during expansion or compression. In some examples, the frame 902 can have only four rows of struts (for example, the first row of struts 930 can be omitted), similar to the frame 102 of FIG. 2.

[0112] FIG. 11 is a side view of an end portion of a prosthetic heart valve frame (which is also referred to herein as a “frame”), according to an example. FIG. 11 illustrates a portion of an exemplary strut 1036 at an axial end of a prosthetic heart valve frame, according to an example, wherein the strut 1036 is depicted in a radially compressed state of the frame.

[0113] The strut 1036 can share certain similarities with the strut 336 of FIG. 5A. For example, the strut 1036 can include a pair of widened strut portions 1031 that can share certain similarities with the widened stmt portions 331, an apex region 1052 that can share certain similarities with the apex region 352, an apex 1054 that can share certain similarities with the apex 354, two thinned strut portions 1056 that can share certain similarities with the thinned stmt portions 356, two transition portions 1058 that can share certain similarities with the transition portions 358, a first side surface 1066 that can share certain similarities with the first side surface 366, and a second side surface 1068 that can share certain similarities with the second side surface 368. As shown, each thinned strut portion 1056 defines a length 1062 extending between its end portions and each transition portion 1058 defines a length 1064 extending between its end portions. As further shown, each thinned strut portion 1056 defines a width 1072 extending between the first and second side surfaces 1066, 1068, each transition region 1058 defines a width 1074 extending between the first and second side surfaces 1066, 1068, and each widened strut portion 1031 defines a width 1070 extending between the first and second side surfaces 1066, 1068.

[0114] When the frame is in the radially compressed state, the inner surface 1066 defines an inner radius of curvature 1076 and the outer surface 1068 defines an outer radius of curvature 1078. As shown, the inner radius of curvature 1076 and the outer radius of curvature 1078 are concentric along the thinned strut portions 1056 such that the thinned strut portions 1056 have constant widths 1072 along their lengths 1062.

[0115] As shown in FIG. 11, one exemplary difference between the strut 1036 and the strut 336 of FIG. 5A (and one exemplary similarity between the strut 1036 and the strut 436 of FIG. 5B) is that the strut 1036 further includes two constant-width transition portions 1080, which can share certain similarities with the constant-width transition portions 480 of FIG.5B. Each constant-width transition portion 1080 (which is also referred to herein as a “linear portion”) can be disposed between a corresponding one of the thinned strut portions 1056 and a corresponding one of the transition portions 1058. Each constant-width transition portion 1080 can define a length 1082 extending between its end portions and a width 1084 extending between the first and second side surfaces 1066, 1068. The width 1084 can be constant along the length 1082 of the constant-width transition portion 1080. As shown, the width 1084 of the constant-width transition portion 1080 is equal to the width 1072 of the thinned strut portions 1056. As such, the width 1074 of the transition regions 1058 can taper from the relatively greater width 1070 of the widened strut portions 1058 to the relatively smaller widths 1072, 1084 of the thinned strut portions 1056 and the constant-width transition portions 1080.

[0116] A length of the apex region 1052 can be the sum of the lengths 1062, 1064, and 1082 of the two thinned strut portions 1056, the two varying-width transition portions 1058, and the two constant-width transition portions 1080.

[0117] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.Delivery Apparatus

[0118] FIG. 4 shows a delivery apparatus 200, according to an example, that can be used to implant an expandable prosthetic heart valve (for example, the prosthetic heart valve 100 of FIG. 1 and / or any of the other prosthetic heart valves described herein). In some examples, the delivery apparatus 200 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0119] The delivery apparatus 200 in the illustrated example of FIG. 4 is a balloon catheter comprising a handle 202 and a steerable, outer shaft 204 extending distally from the handle 202. The delivery apparatus 200 can further comprise an intermediate shaft 206 (which also may be referred to as a balloon shaft) that extends proximally from the handle 202 and distally from the handle 202, the portion extending distally from the handle 202 also extending coaxially through the outer shaft 204. Additionally, the delivery apparatus 200 can further comprise an inner shaft 208 extending distally from the handle 202 coaxially through the intermediate shaft 206 and the outer shaft 204 and proximally from the handle 202 coaxially through the intermediate shaft 206.

[0120] The outer shaft 204 and the intermediate shaft 206 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 220 of the delivery apparatus 200, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient’s body.

[0121] The intermediate shaft 206 can include a proximal end portion 210 that extends proximally from a proximal end of the handle 202, to an adaptor 212. A rotatable knob 214 can be mounted on the proximal end portion 210 and can be configured to rotate the intermediate shaft 206 around the central longitudinal axis 220 and relative to the outer shaft 204.

[0122] The adaptor 212 can include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 240 can be fluidly coupled to an inner lumen of the intermediate shaft 206.

[0123] The intermediate shaft 206 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 204 when a distal end of the outer shaft 204 is positioned away from an inflatable balloon 218 of the delivery apparatus 200. A distal end portion of the inner shaft 208 can extend distally beyond the distal end portion of the intermediate shaft 206.

[0124] The balloon 218 can be coupled to the distal end portion of the intermediate shaft 206.

[0125] In some examples, a distal end of the balloon 218 can be coupled to a distal end of the delivery apparatus 200, such as to a nose cone 222 (as shown in FIG. 4), or to an alternate component at the distal end of the delivery apparatus 200 (for example, a distal shoulder). An intermediate portion of the balloon 218 can overlay a valve mounting portion 224 of a distal end portion of the delivery apparatus 200 and a distal end portion of the balloon 218 can overly a distal shoulder 226 of the delivery apparatus 200. The valve mounting portion 224 and the intermediate portion of the balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 4, a prosthetic heart valve 250 (which can be one of the prosthetic valves described herein) can be mounted around the balloon 218, at the valve mounting portion 224 of the delivery apparatus 200.

[0126] The balloon shoulder assembly, including the distal shoulder 226, is configured to maintain the prosthetic heart valve 250 (or other medical device) at a fixed position on the balloon 218 during delivery through the patient’s vasculature.

[0127] The outer shaft 204 can include a distal tip portion 228 mounted on its distal end. The outer shaft 204 and the intermediate shaft 206 can be translated axially relative to one another to position the distal tip portion 228 adjacent to a proximal end of the valve mounting portion 224, when the prosthetic valve 250 is mounted in the radially compressed state on the valve mounting portion 224 (as shown in FIG. 4) and during delivery of the prosthetic valve to the target implantation site. As such, the distal tip portion 228 can be configured to resist movement of the prosthetic valve 250 relative to the balloon 218 proximally, in the axial direction, relative to the balloon 218, when the distal tip portion 228 is arranged adjacent to a proximal side of the valve mounting portion 224.

[0128] An annular space can be defined between an outer surface of the inner shaft 208 and an inner surface of the intermediate shaft 206 and can be configured to receive fluid from a fluid source via the second port 240 of the adaptor 212. The annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 208 and an inner surface of the balloon 218. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the balloon 218 and radially expand and deploy the prosthetic valve 250.

[0129] An inner lumen of the inner shaft can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 200 to the target implantation site.

[0130] The handle 202 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 200. In the illustrated example, for example, the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 202 through the outer shaft 204 and has a distal end portion affixed to the outer shaft 204 at or near the distal end of the outer shaft 204. Rotating the knob 260 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 200. Further details on steering or flex mechanisms for the delivery apparatus can be found in U. S. Patent No. 9,339,384, which is incorporated by reference herein in its entirety.

[0131] The handle 202 can further include an adjustment mechanism 261 including an adjustment member, such as the illustrated rotatable knob 262, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 278. The adjustment mechanism 261 is configured to adjust the axial position of the intermediate shaft 206 relative to the outer shaft 204 (for example, for fine positioning at the implantation site). Further details on the delivery apparatus 200 can be found in PCT Publication No. WO2022 / 046585 which is incorporated by reference herein in its entirety.

[0132] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Delivery Techniques.

[0133] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the21distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to selfexpand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aorticvalve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-stemotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve,

[0134] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0135] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic-valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulrnonary artery.

[0136] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0137] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.Additional Examples of the Disclosed Technology

[0138] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0139] Example 1. A prosthetic heart valve can include a radially expandable and compressible annular frame and a plurality of leaflets mounted on an inside of the annular frame. The frame can include an inflow end, an outflow end, and a plurality of interconnected struts defining a plurality of rows of cells arranged between the inflow end and the outflow end of the frame. The plurality of interconnected struts can include a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. At least one inflow strut or at least one outflow strut can include an apex region curving between a corresponding pair of two angled strut portions. The apex region can have a narrowed width smaller than a width of the two angled strut portions. The apex region can have a length in a range from 3% to 10% of a total length of the outflow strut or the inflow strut.

[0140] Example 2. The prosthetic heart valve of any example herein, particularly Example 1, wherein at least one outflow strut of the plurality of outflow struts can include the apex region.

[0141] Example 3. The prosthetic heart valve of any example herein, particularly Example 2, wherein each outflow strut of the plurality of outflow struts can include the apex region.

[0142] Example 4. The prosthetic heart valve of any example herein, particularly any one of Examples 1-3, wherein at least one inflow strut of the plurality of inflow struts can include the apex region.

[0143] Example 5. The prosthetic heart valve of any example herein, particularly Example 4, wherein each inflow strut of the plurality of inflow struts can include the apex region.

[0144] Example 6. The prosthetic heart valve of any example herein, particularly any one of Examples 1-5, wherein the apex region can include at least one thinned strut portion connecting the two angled strut portions.

[0145] Example 7. The prosthetic heart valve of any example herein, particularly Example 6, wherein the at least one thinned strut portion can include an inner surface defining an inner radius of curvature and an outer surface defining and outer radius of curvature, and wherein the outer surface can be closer than the inner surface to an apex of the apex region.

[0146] Example 8. The prosthetic heart valve of any example herein, particularly Example 7, wherein the inner radius of curvature and the outer radius of curvature can be concentric along a length of the at least one thinned strut portion.

[0147] Example 9. The prosthetic heart valve of any example herein, particularly Example 7, wherein the inner radius of curvature and the outer radius of curvature are not concentric along a length of the at least one thinned strut portion.

[0148] Example 10. A prosthetic heart valve can include a radially expandable and compressible annular frame and a plurality of leaflets mounted on an inside of the annular frame. The annular frame can include an inflow end, an outflow end, and a plurality of interconnected stmts defining a plurality of rows of cells arranged between the inflow end and the outflow end of the frame. The plurality of interconnected struts can include a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. At least one inflow strut or at least one outflow strut can include an apex region curving between a corresponding pair of two angled strut portions. The apex region can include a notch.

[0149] Example 11. The prosthetic heart valve of any example herein, particularly Example 10, wherein the notch can be equidistant between the two angled strut portions.

[0150] Example 12. The prosthetic heart valve of any example herein, particularly any one of Examples 10-11, wherein the apex region can include an inner surface and an outer surface, wherein the outer surface can be closer than the inner surface to an apex of the apex region, and wherein the notch can extend from the inner surface towards the outer surface.

[0151] Example 13. The prosthetic heart valve of any example herein, particularly any one of Examples 10-12, wherein the notch can have a “v”-shape.

[0152] Example 14. The prosthetic heart valve of any example herein, particularly any one of Examples 10-13, wherein the at least one inflow stmt or at least one outflow stmt can include two angled strut portions, and wherein the apex region can include at least one thinned stmt portion disposed between the two angled stmt portions.

[0153] Example 15. The prosthetic heart valve of any example herein, particularly Example 14, wherein the at least one inflow strut or at least one outflow strut can include a transition portion coupling the at least one thinned strut portion and a corresponding one of the two angled strut portions.

[0154] Example 16. The prosthetic heart valve of any example herein, particularly any one of Examples 14-15, wherein the frame can be in a radially compressed state, the at least one thinned strut portion can define an inner radius of curvature and an outer radius of curvature, and the inner radius of curvature and outer radius of curvature can be concentric.

[0155] Example 17. A prosthetic heart valve can include a radially expandable and compressible annular frame and a plurality of leaflets mounted on an inside of the annular frame. The annular frame can include an inflow end, an outflow end, and a plurality of interconnected stmts defining a plurality of rows of cells arranged between the inflow end and the outflow end of the frame. The plurality of interconnected struts can include a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. At least one inflow strut or at least one outflow strut can include an apex region curving between a corresponding pair of two angled strut portions. The apex region can include a head having an elliptical cross-section coupled to each of the two angled stmt portions.

[0156] Example 18. The prosthetic heart valve of any example herein, particularly Example 17, wherein the head can have an oval cross-section.

[0157] Example 19. The prosthetic heart valve of any example herein, particularly any one of Examples 17-18, wherein at least one outflow strut can include the apex region that includes the head with the elliptical cross-section.

[0158] Example 20. The prosthetic heart valve of any example herein, particularly any one of Examples 17-19, wherein the head can have a flat radially outwards -facing side.

[0159] Example 21. The prosthetic heart valve of any example herein, particularly any one of Examples 17-20, wherein the head can be elongated in a circumferential direction of the prosthetic heart valve.

[0160] Example 22. The prosthetic heart valve of any example herein, particularly any one of Examples 17-21, wherein the head can have a maximum circumferential width that is greater than a width of the head where the angled strut portions couple to the head.

[0161] Example 23. The prosthetic heart valve of any example herein, particularly any one of Examples 17-22, wherein the head and the two angled strut portions can be coupled at a junction, and wherein the junction can include a concave inner surface.

[0162] Example 24. The prosthetic heart valve of any example herein, particularly Example 23, wherein the concave inner surface can be “u”-shaped.

[0163] Example 25. The prosthetic heart valve of any example herein, particularly Example 23, wherein the concave inner surface can be “v”-shaped.

[0164] Example 26. A prosthetic heart valve can include a radially expandable and compressible annular frame and a plurality of leaflets mounted on an inside of the annular frame. The radially expandable and compressible annular frame can include an inflow end, an outflow end, and a plurality of interconnected struts defining a plurality of rows of cells arranged between the inflow end and the outflow end of the frame. The plurality of interconnected struts can include a plurality of outflow stmts defining the outflow end and a plurality of inflow stmts defining the inflow end. At least one inflow strut or at least one outflow strut can include an apex region curving between a corresponding pair of two angled strut portions. The apex region can define an arc length along which the apex region has a constant width. The arc length can be in a range from approximately 0.25 millimeters to approximately 0.85 millimeters.

[0165] Example 27. The prosthetic heart valve of any example herein, particularly Example 26, wherein the arc length can be in a range from approximately 0.25 millimeters to approximately 0.35 millimeters.

[0166] Example 28. The prosthetic heart valve of any example herein, particularly Example 26, wherein the arc length can be in a range from approximately 0.4 millimeters to approximately 0.5 millimeters.

[0167] Example 29. The prosthetic heart valve of any example herein, particularly Example 28, wherein at least one outflow strut can include the apex region.

[0168] Example 30. The prosthetic heart valve of any example herein, particularly Example 26, wherein the arc length can be in a range from approximately 0.7 millimeters to approximately 0.85 millimeters.

[0169] Example 31. The prosthetic heart valve of any example herein, particularly Example 30, wherein at least one inflow strut can include the apex region.

[0170] Example 32. The prosthetic heart valve of any example herein, particularly any one of Examples 24-29, wherein: at least one inflow strut can include an inflow apex region having an inflow arc length, at least one outflow strut can include an outflow apex region having an outflow arc length, and the inflow arc length can be greater than the outflow arc length.

[0171] Example 33. A prosthetic valve can include a radially expandable and compressible annular frame and a plurality of leaflets mounted on an inside of the annular frame. The frame can include an inflow end, an outflow end, and a plurality of interconnected struts defining a plurality of rows of cells arranged between the inflow end and the outflow end of the frame. The plurality of interconnected struts can include a plurality of outflow struts defining the outflow end and a plurality of inflow struts defining the inflow end. At least one inflow strut or at least one outflow strut can include an apex region curving between a corresponding pair of two angled strut portions. The apex region can include at least one thinned strut portion defining an inner radius of curvature and an outer radius of curvature, wherein the inner radius of curvature and the outer radius of curvature can be non-concentric.

[0172] Example 34. The prosthetic valve of any example herein, particularly Example 33, wherein the at least one inflow strut or at least one outflow strut can include two angled strut portions, and wherein the apex region can include at least one thinned strut portion disposed between the two angled strut portions.

[0173] Example 35. The prosthetic valve of any example herein, particularly Example 34, wherein the at least one inflow strut or at least one outflow strut can include a transition portion disposed between the at least one thinned strut portion and a corresponding one of the two angled strut portions.

[0174] Example 36. The prosthetic valve of any example herein, particularly Example 35, wherein the transition portion can have a constant width.

[0175] Example 37. The prosthetic valve of any example herein, particularly Example 35, wherein the transition portion can have a varying width.

[0176] Example 38. The prosthetic heart valve of any example herein, particularly Example 37, wherein the at least inflow strut or at least one outflow strut further includes a constant width portion disposed between the transition portion and the at least one thinned strut portion, wherein a width of the constant width portion is equal to a width of the thinned strut portion.

[0177] Example 39. The prosthetic valve of any example herein, wherein the prosthetic valve is sterilized.

[0178] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one prosthetic heart valve can be combined with any one or more features of another prosthetic heart valve. As another example, any one or more features of one frame can be combined with any one or more features of another frame.

[0179] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

Claims:

1. A prosthetic heart valve comprising:a radially expandable and compressible annular frame comprising:an inflow end;an outflow end; anda plurality of interconnected stmts defining a plurality of rows of cells arranged between the inflow end and the outflow end of the frame, the plurality of interconnected stmts comprising:a plurality of outflow stmts defining the outflow end; and a plurality of inflow stmts defining the inflow end, wherein:at least one inflow stmt or at least one outflow stmt includes an apex region curving between a corresponding pair of two angled strut portions, the apex region has a narrowed width smaller than a width of the two angled stmt portions, andthe apex region has a length in a range from 3% to 10% of a total length of the outflow strut or the inflow strut; anda plurality of leaflets mounted on an inside of the annular frame.

2. The prosthetic heart valve of claim 1, wherein at least one outflow strut of the plurality of outflow struts comprises the apex region.

3. The prosthetic heart valve of any one of claims 1-2, wherein at least one inflow strut of the plurality of inflow struts comprises the apex region.

4. The prosthetic heart valve of any one of claims 1-3, wherein the apex region comprises at least one thinned strut portion connecting the two angled strut portions.

5. The prosthetic heart valve of claim 4, wherein the at least one thinned strut portion includes an inner surface defining an inner radius of curvature and an outer surface defining and outer radius of curvature, and wherein the outer surface is closer than the inner surface to an apex of the apex region.

6. The prosthetic heart valve of claim 5, wherein the inner radius of curvature and the outer radius of curvature are concentric along a length of the at least one thinned strut portion.

7. The prosthetic heart valve of claim 5, wherein the inner radius of curvature and the outer radius of curvature are not concentric along a length of the at least one thinned strut portion.

8. A prosthetic heart valve comprising:a radially expandable and compressible annular frame comprising:an inflow end;an outflow end; anda plurality of interconnected struts defining a plurality of rows of cells arranged between the inflow end and the outflow end of the frame, the plurality of interconnected struts comprising:a plurality of outflow struts defining the outflow end; anda plurality of inflow struts defining the inflow end, wherein:at least one inflow strut or at least one outflow strut includes an apex region curving between a corresponding pair of two angled strut portions, and the apex region includes a notch; anda plurality of leaflets mounted on an inside of the annular frame.

9. The prosthetic heart valve of claim 8, wherein the notch is equidistant between the two angled strut portions.

10. The prosthetic heart valve of any one of claims 8-9, wherein the apex region includes an inner surface and an outer surface, wherein the outer surface is closer than the inner surface to an apex of the apex region, and wherein the notch extends from the inner surface towards the outer surface.

11. The prosthetic heart valve of any one of claims 8-10, wherein the at least one inflow strut or at least one outflow strut includes two angled strut portions, and wherein the apex region comprises at least one thinned strut portion disposed between the two angled strut portions.

12. The prosthetic heart valve of claim 11, wherein the at least one inflow strut or at least one outflow strut includes a transition portion coupling the at least one thinned strut portion and a corresponding one of the two angled strut portions.

13. The prosthetic heart valve of any one of claims 11-12, wherein:the frame is in a radially compressed state,the at least one thinned strut portion defines an inner radius of curvature and an outer radius of curvature, andthe inner radius of curvature and outer radius of curvature are concentric.

14. A prosthetic heart valve comprising:a radially expandable and compressible annular frame comprising:an inflow end;an outflow end; anda plurality of interconnected struts defining a plurality of rows of cells arranged between the inflow end and the outflow end of the frame, the plurality of interconnected struts comprising:a plurality of outflow struts defining the outflow end; anda plurality of inflow struts defining the inflow end, wherein:at least one inflow strut or at least one outflow strut includes an apex region curving between a corresponding pair of two angled strut portions, the apex region defines an arc length along which the apex region has a constant width, andthe arc length is in a range from approximately 0.25 millimeters to approximately 0.85 millimeters; anda plurality of leaflets mounted on an inside of the annular frame.

15. The prosthetic heart valve of claim 14, wherein the arc length is in a range from approximately 0.25 millimeters to approximately 0.35 millimeters.

16. The prosthetic heart valve of claim 14, wherein the arc length is in a range from approximately 0.4 millimeters to approximately 0.5 millimeters.

17. The prosthetic heart valve of claim 15, wherein at least one outflow strut includes the apex region.

18. The prosthetic heart valve of claim 14, wherein the arc length is in a range from approximately 0.7 millimeters to approximately 0.85 millimeters.

19. The prosthetic heart valve of claim 18, wherein at least one inflow strut includes the apex region.

20. The prosthetic heart valve of any one of claims 14-19, wherein:at least one inflow strut includes an inflow apex region having an inflow arc length, at least one outflow strut includes an outflow apex region having an outflow arc length, andthe inflow arc length is greater than the outflow arc length.

Images