Prosthetic heart valve having radiopaque markers for commissure alignment

Abstract

A prosthetic heart valve can include a frame, a valvular structure coupled to the frame, a commissure formed by the valvular structure, and a radiopaque marker fixedly attached to the commissure. The frame can include a plurality of struts that form a plurality of commissure windows spaced circumferentially apart around the frame. The commissure can be secured to a respective one of the plurality of commissure windows. In some examples, the radiopaque marker can include a central longitudinal axis, and the radiopaque marker can be asymmetric about the central longitudinal axis. In some examples, the radiopaque marker can help a user better determine a circumferential position or orientation of the prosthetic heart valve under fluoroscopy without having to mount the prosthetic heart valve onto a delivery apparatus in a specific, predetermined orientation.

Description

PROSTHETIC HEART VALVE HAVING RADIOPAQUE MARKERS FORCOMMISSURE ALIGNMENTCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 564,933, filed on March 13, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to prosthetic heart valves that include radiopaque markers.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, delivery apparatuses, and methods for implanting prosthetic heart valves. The disclosed prosthetic heart valves, delivery apparatus, and methods can, for example, provide for improved alignment between the prosthetic heart valve and the patient’s native anatomy. As such, the devices and methods disclosed herein can,among other things, overcome one or more of the deficiencies of typical prosthetic heart valves, delivery apparatuses, and methods.

[0005] A prosthetic heart valve can include a frame.

[0006] In some example, the frame that can include a plurality of struts that can form a plurality of commissure windows spaced circumferentially apart around the frame.

[0007] In some examples, the prosthetic heart valve can include a valvular structure coupled to the frame.

[0008] In some examples, the prosthetic heart valve can include a commissure formed by the valvular structure.

[0009] In some examples, the commissure can be secured to a respective one of the plurality of commissure windows of the frame.

[0010] In some examples, the prosthetic heart valve can include a radiopaque marker fixedly attached to the commissure.

[0011] In some examples, the valvular structure can include a first leaflet that can include a first tab, a second leaflet that can include a second tab, and a flexible connector secured to each one of the first tab and the second tab.

[0012] In some examples, the first tab, the second tab, and a portion of the flexible connector can extend through the commissure window,

[0013] In some examples, the first leaflet, the second leaflet, and the flexible connector can form the commissure.

[0014] In some examples, the radiopaque marker can be fixedly attached to the flexible connector outside of the frame.

[0015] In some examples, the radiopaque marker can be sutured to the flexible connector.

[0016] In some examples, the flexible connector can include a first end portion, a second end portion opposite the first end portion, and a central portion disposed between the first end portion and the second end portion.

[0017] In some examples, the radiopaque marker can be fixedly attached to the central portion of the flexible connector.

[0018] In some examples, the flexible connector can include a flap extending from the central portion in a direction that is perpendicular to both the first end portion and the second end portion.

[0019] In some examples, the flap can be folded over the central portion of the flexible connector and can cover the radiopaque marker.

[0020] In some examples, the flexible connector can include a central portion, a first side portion extending in a first circumferential direction from the central portion, a second side portion extending in a second circumferential direction from the central portion, and a flap extending in the first circumferential direction from the first side portion.

[0021] In some examples, the radiopaque marker can be fixedly attached to the flap of the flexible connector.

[0022] In some examples, radiopaque marker can include a central longitudinal axis.

[0023] In some examples, the radiopaque marker can be asymmetric about the central longitudinal axis.

[0024] In some examples, the radiopaque marker can have an E- shape.

[0025] In some examples, the radiopaque marker can have a C-shape.

[0026] In some examples, the radiopaque marker can have a greater radiopacity than the annular frame, the first leaflet, and the second leaflet.

[0027] In some examples, the radiopaque marker can include at least one alignment feature.

[0028] In some examples, the at least one alignment feature can include a first alignment feature disposed at a proximal end portion of the radiopaque marker and a second alignment feature disposed at a distal end portion of the radiopaque marker.

[0029] In some examples, the at least one alignment feature can include at least one notch.

[0030] A method can include securing a first tab of a first leaflet to a first end portion of a flexible connector, securing a second tab of a second leaflet to a second end portion of the flexible connector, wherein the first end portion can be opposite the second end portion, inserting at least a portion of the first tab, at least a portion of the second tab, and at least a portion of the flexible connector though a commissure window of a radially compressible and expandable frame to form a commissure.

[0031] In some examples, the method can include coupling a radiopaque marker to the commissure.

[0032] In some examples, coupling the radiopaque marker to the commissure can include coupling the radiopaque marker to the central portion of the flexible connector.

[0033] A method can include mounting a prosthetic medical device to a distal end portion of a delivery apparatus, wherein the prosthetic medical device can include a frame, at least one commissure, and a radiopaque marker coupled to the at least one commissure outside of the frame, advancing the prosthetic medical device and the distal end portion of the delivery apparatus through a subject’s vasculature to an implantation site, and visualizing the radiopaque marker under fluoroscopy to determine a circumferential position of the prosthetic medical device relative to the implantation site.

[0034] In some examples, the implantation site can be a native aortic annulus.

[0035] In some examples, visualizing the radiopaque marker under fluoroscopy can include determining a circumferential position of the radiopaque marker relative to at least one coronary artery adjacent the native aortic annulus.

[0036] In some examples, visualizing the radiopaque marker under fluoroscopy can include determining, based on a direction of the visualization of the radiopaque marker, whether the radiopaque marker is in a front plane or a back plane of a fluoroscope image.

[0037] In some examples, a prosthetic heart valve can include a frame, a valvular structure coupled to the frame, a commissure formed by the valvular structure, and a radiopaque marker fixedly attached to the commissure. The frame can include a plurality of struts that can form a plurality of commissure windows spaced circumferentially apart around the frame. The commissure can be secured to a respective one of the plurality of commissure windows.

[0038] In some examples, a prosthetic heart valve can include an annular frame that includes at least one window frame portion, a first leaflet and a second leaflet, and a radiopaque marker. The first leaflet and the second leaflet can be secured to one another at their adjacent sides to form a commissure that is coupled to the at least one window frame portion of the annular frame. The radiopaque marker can be coupled to the commissure outside of the frame.

[0039] In some examples, a prosthetic heart valve can include a frame that includes a plurality of struts, a valvular structure coupled to the frame, wherein the valvular structure comprises a flexible connector that includes a central portion, a first side portion extending in a first circumferential direction from the central portion, a second side portion extending in a second circumferential direction from the central portion, and a flap extending in the first circumferential direction from the first side portion, and a radiopaque marker fixedly attached to the flexible connector.

[0040] In some examples, a method can include securing a first tab of a first leaflet to a first end portion of a flexible connector, securing a second tab of a second leaflet to a second end portion of the flexible connector, wherein the first end portion can be opposite the second end portion, inserting at least a portion of the first tab, at least a portion of the second tab, and at least a portion of the flexible connector though a commissure window of a radially compressible and expandable frame to form a commissure; and coupling a radiopaque marker to the commissure.

[0041] In some examples, a method can include mounting a prosthetic medical device to a distal end portion of a delivery apparatus, wherein the prosthetic medical device can include a frame, at least one commissure, and a radiopaque marker coupled to the at least one commissure outside of the frame, advancing the prosthetic medical device and the distal end portion of the delivery apparatus through a subject’s vasculature to an implantation site, and visualizing the radiopaque marker under fluoroscopy to determine a circumferential position of the prosthetic medical device relative to the implantation site.

[0042] In some examples, a prosthetic heart valve can comprise: a frame comprising a plurality of struts, a valvular structure coupled to the frame, a commissure formed by the valvular structure, and a radiopaque marker positioned at the commissure and having at least one alignment feature for aligning with a guidewire.

[0043] In some examples, a method can comprise: mounting a prosthetic heart valve to a distal end portion of a delivery apparatus, wherein the prosthetic heart valve includes a frame, at least one commissure, and a radiopaque marker coupled to the at least one commissure, wherein the radiopaque marker comprises at least one alignment feature, advancing the prosthetic heart valve and the distal end portion of the delivery apparatus over a guidewire and through a subject’s vasculature to an implantation site, and, under fluoroscopy,visualizing the radiopaque marker and the guidewire and aligning the at least one alignment feature of the radiopaque marker with the guidewire.

[0044] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with body parts, heart, tissue, etc. being simulated).

[0045] 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

[0046] FIG. 1 is a side view of a prosthetic heart valve, according to an example.

[0047] FIG. 2 is a side view of a prosthetic heart valve delivery apparatus, according to an example.

[0048] FIG. 3 is a flattened view of two leaflets of the prosthetic heart valve of FIG. 1 interconnected by a flexible connector.

[0049] FIG. 4 is a cross-sectional view of a portion of a frame and a valvular structure of the prosthetic heart valve of FIG. 1.

[0050] FIG. 5 is a side view of the portion of the frame and the valvular structure of the prosthetic heart valve of FIG. 1.

[0051] FIG. 6 is a side view of an asymmetric radiopaque marker and a flexible connector for a prosthetic heart valve, according to an example, wherein the flexible connector is shown in an unfolded configuration.

[0052] FIG. 7 is a side view of the flexible connector of FIG. 6 shown in a folded configuration.

[0053] FIG. 8 is a side view of a prosthetic heart valve comprising a radiopaque marker, according to an example.

[0054] FIG. 9 is a side view of a portion of the prosthetic heart valve of FIG. 8.

[0055] FIG. 10 is a side view of an asymmetric radiopaque marker, according to an example.

[0056] FIG. 11 is a side view of a flexible connector for a prosthetic heart valve, according to an example, wherein the flexible connector is shown in an unfolded configuration.

[0057] FIG. 12 is a perspective view of the flexible connector of FIG. 11 attached to a frame of a prosthetic heart valve and shown in a partially assembled state, according to an example.

[0058] FIG. 13 is a perspective view of a portion of the flexible connector of FIG. 12, wherein a radiopaque marker is shown being stitched to a flap of the flexible connector.

[0059] FIG. 14 is a perspective view of the flexible connector and radiopaque marker of FIG. 13, wherein the flexible connector of FIG. 11 is shown in a folded configuration.

[0060] FIG. 15 is a cross-sectional view of a portion of the frame and flexible connector of FIG. 12.DETAILED DESCRIPTIONGeneral Considerations

[0061] 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.

[0062] 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 that correspondto these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0063] 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.

[0064] 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.

[0065] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Introduction to the Disclosed Technology

[0066] In some examples of a transcatheter aortic valve replacement (“TAVR”) procedure, a prosthetic heart valve (which is also referred to herein as a “prosthetic valve”) can be mounted onto a distal end portion of a prosthetic heart valve delivery apparatus (which is also referred to herein as a “delivery apparatus”), advanced through a subject’s vasculature using the delivery apparatus, and implanted at a subject’s native aortic annulus. In some examples of the TAVR procedure, it can be desirable to implant the prosthetic heart valve in a particular alignment, position, or orientation relative to the subject’s native anatomy. For example, the prosthetic heart valve can be aligned such that commissures of the prosthetic heart valve are offset in a circumferential direction from the subject’s the left and right coronary arteries, such as by aligning the commissures of the prosthetic heart valve with the commissures of the native aortic valve. In some examples, circumferentially offsetting the commissures of the prosthetic heart valve from the subject’s left and right coronary arteries can further increase the likelihood that the prosthetic heart valve permits blood flow through the subject’s coronary arteries andcan facilitate access to one or both coronary arteries via the prosthetic heart valve in a postimplantation procedure.

[0067] In some examples of a “valve- in- valve” TAVR procedure, in which a prosthetic heart valve is implanted inside a previously-implanted prosthetic medical device (for example, a previously-implanted prosthetic heart valve, a prosthetic heart valve docking device, etc.), it can be desirable to circumferentially align certain features of the prosthetic heart valve (for example commissures of the prosthetic heart valve) with certain features of the prosthetic medical device (for example, commissures of the previously-implanted prosthetic heart valve). In some examples of a valve-in- valve TAVR procedure, it is desirable to align the commissures of the new prosthetic heart valve (the “guest valve”) with the commissures of the previously implanted prosthetic heart valve (the “host valve”) to facilitate access to the coronary arteries.

[0068] In some examples of the TAVR procedure, a user (for example, a doctor, clinician, etc.) can use fluoroscopy to orient the prosthetic heart valve in a particular circumferential position relative to the subject’s native anatomy and / or the previously-implanted prosthetic medical device. For example, the user can use fluoroscopy to visualize a radiopaque marker affixed to the distal end portion of the delivery apparatus relative to the surrounding native anatomy (for example, the native aortic valve, coronary arteries, etc.), a guidewire extending through the delivery apparatus, and / or a second prosthetic medical device. If the prosthetic heart valve is mounted onto the delivery apparatus in a predetermined orientation relative to the radiopaque marker and / or the distal end of the delivery apparatus, the user can determine the orientation of the prosthetic heart valve relative to the native anatomy, guidewire, and / or other prosthetic medical device based on the visualized position of the radiopaque marker fixed to the delivery apparatus and the known predetermined orientation of the prosthetic heart valve relative to the delivery apparatus.

[0069] However, in such examples, the prosthetic heart valve must be aligned with the radiopaque marker of the delivery apparatus in the specific, predetermined orientation prior to implantation. Thus, there is a need for a prosthetic heart valve and / or method of implanting a prosthetic heart valve that does not require such alignment prior to implantation.

[0070] Described herein are various examples of a prosthetic heart valve that includes a radiopaque marker. Since the radiopaque marker is attached directly to the prosthetic heart valve, the user does not need to mount the prosthetic heart valve onto the delivery apparatus in a specific, predetermined orientation in order to determine the orientation of the prosthetic heartvalve and / or a portion thereof (for example, the commissures of the prosthetic heart valve) relative to the subject’s native anatomy under fluoroscopy, thereby beneficially simplifying the prosthetic heart valve implantation procedure. Furthermore, in some examples, the radiopaque marker is asymmetric, allowing the user to easily determine whether the radiopaque marker is in a front plane or back plane of a fluoroscopic image.

[0071] Although this introduction to the disclosed technology is described with reference to a prosthetic heart valve and a TAVR procedure, it should be understood that the exemplary radiopaque markers disclosed herein can included on any implantable medical device (for example, a prosthetic heart valve docking device, a stent, and / or any prosthetic medical device) and / or used in conjunction with any medical procedure (for example, a mitral valve replacement procedure, a tricuspid valve replacement procedure, a pulmonary valve replacement procedure, etc.).Examples of the Disclosed Technology

[0072] 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.

[0073] 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.Example Prosthetic Heart Valve

[0074] FIG. 1 shows an exemplary prosthetic heart valve 100, according to an example. Any of 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 prostheticheart valves also can be implanted within vessels communicating 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 heart valves also can be implanted within a previously implanted prosthetic heart valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in- valve procedure.

[0075] In some examples, the disclosed prosthetic heart valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, the disclosed prosthetic heart 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 heart 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 by reference herein. In another example, the disclosed prosthetic heart 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 by reference herein.

[0076] The prosthetic heart valve 100 can comprise a frame 112, a valvular structure 114, an inner skirt 116, and a perivalvular outer sealing member or outer skirt 118. The prosthetic valve 100 can comprise an inflow end portion 115 and an outflow end portion 119, and an intermediate portion 117 extending therebetween.

[0077] The frame 112 can comprise an annular structure that is radially compressible and expandable. The frame 112 can comprise a plurality of struts that form the annular structure. The plurality of struts can form a plurality of window frame portions 130 of the frame 112 that can be spaced apart in a circumferential direction of the frame 1 12. Each window frame portion 130 can define an axially extending commissure window 132. Thus, the frame 112 can comprise a plurality of commissure windows 132, which can similarly be spaced apart in the circumferential direction of the frame 112.

[0078] The frame 112 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol) as known in the art. When constructed of a plastically-expandable material, the frame 112 (and thus theprosthetic heart valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable catheter balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 112 (and thus the prosthetic heart 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 prosthetic heart valve 100 can be advanced from the delivery sheath, which allows the prosthetic heart valve 100 to expand to its functional size.

[0079] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 112) 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 112 can comprise stainless steel. In some examples, the frame 112 can comprise cobalt-chromium. In some examples, the frame 112 can comprise nickel-cobalt-chromium. In some examples, the frame 112 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R3OO35 (covered by ASTM F562-02). MP35N™ / UNS R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0080] The valvular structure 114 (which is also referred to herein as a “leaflet structure”) can comprise a plurality of leaflets 140 collectively forming a leaflet structure. In some examples, the valvular structure 1 14 can comprise three leaflets 140 arranged in a tricuspid arrangement. However, there can be a greater or fewer number of leaflets 140. The leaflets can be secured to one another at their adjacent sides to form commissures 122 of the valvular structure 114. The lower edge of the valvular structure 114 can have an undulating, curved scalloped shape, and can be secured to the inner skirt 116 by sutures (not shown). In some examples, the leaflets 140 can be formed of pericardial tissue (such as bovine pericardial tissue), biocompatible synthetic materials, or other various 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.

[0081] The inner skirt 116 and / or the outer skirt 118 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 skirts 116, 118 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 skirts116, 118 can comprise a fabric without 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 yams or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirts 116, 118 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 skirts 116, 118 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirts 116, 118 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0082] FIG. 3 is a flattened view of two leaflets 140 interconnected by a flexible connector 124 (which is also referred to herein as a “fabric connector”). The flexible connector 124 can include opposing end portions 126 disposed on either side of a central portion 128. As shown, each leaflet 140 includes two lower tabs 142 (which are also referred to herein as “primary tabs”) on opposite sides of the leaflet 140. Opposite end portions of the flexible connector 124 can be placed in an overlapping relationship with the lower tabs 142. Each lower tab 142 can be secured to a corresponding end portion 126 of the flexible connector 124 by suturing along a line extending from a lower edge the flexible connector 124 to an upper edge of the flexible connector 124. Three leaflets 140 can be secured to each other side-to-side using three flexible connectors 124. As further shown, each leaflet 140 further includes two upper tabs 144 (which are also referred to herein as “secondary tabs”). As further shown, each upper tab 144 is adjacent a corresponding one of the lower tabs 142 and extends away from a free edge of the leaflet 140 and / or the corresponding lower tab 142.

[0083] FIG. 4 is a cross-sectional view of a portion of the frame 112 and the valvular structure 114. As shown, the commissure 122 is formed by inserting at least portions of two adjacent lower tabs 142 of a pair of adjacent leaflets 140 and at least a portion of the flexible connector 124 connecting the adjacent lower tabs 142 through a respective commissure window 132 defined between two struts or posts 131a, 131b of a window frame portion 130 of the frame 112. As further shown, a wedge 146 presses the lower tabs 142 and the flexible connector 124 against the frame 112 in a radially inwards-facing direction, such that a portion of the first lower tab 142 of one leaflet 140 and a first portion of the flexible connector 124 are foldedagainst the outside of the frame 112 at the first strut 131a and a portion of the second lower tab portion 142 of the other leaflet 140 and a second portion of the flexible connector 124 are folded against outside of the frame 112 at the second strut 131b.

[0084] As shown, each one of the upper tabs 144 is folded along a vertical fold axis to form an L-shape that includes an inner portion 154 and an outer portion 156. The inner portion 154 can contact a surface of the main body of the leaflet 140 and the outer portion 156 can contact the flexible connector 124. The outer portion 156 can be sutured to the flexible connector 124 using a suture 158.

[0085] As shown, a pair of suture lines 148 are formed to retain portions of the lower tabs 142 against the frame 112 in the manner shown in FIGS. 4-5. Each suture line 148 extends through the flexible connector 124, the lower tab 142, the wedge 146, and another portion of the flexible connector 124. Then, as shown, each lower tab 142 is secured to a corresponding one of the upper tabs 144 with a primary suture line 150 that extends through one layer of the flexible connector 124, the lower tab 142, another layer of the flexible connector 124, another layer of the flexible connector 124, and the outer portion 156 of the upper tab 144. Finally, as shown, the suture material used to form the primary suture line 150 can be used to further form whip stitches 152 at the edges of the lower and upper tabs 142, 144. The whip stitches 152 can extend through two layers of the flexible connector 124 that can be sandwiched between portions of the lower and upper tabs 142, 144.

[0086] During valve cycling, the leaflets 140 can articulate primarily at inner edges 160 of the folded inner portions 154 of the upper tabs 144. However, when the prosthetic heart valve 100 is radially compressed to a delivery state, the relatively higher forces acting on the leaflets 140 can cause the leaflets 140 to splay apart about a longitudinal axis 162, allowing for a smaller crimped diameter.

[0087] FIG. 5 is a side view of the portion of the frame 112 and the valvular structure 114. FIGS. 4-5 shows the fully assembled commissure 122, which in the illustrated example includes the flexible connector 124, the folded lower tabs 142, the folded upper tabs 144, the suture lines 148, the primary suture lines 150, and the whip stitches 152.

[0088] The remaining commissure tab assemblies of the valvular structure 114 can be coupled to respective commissure windows portions 130 of the frame 112 in the same manner as described above. Further details of the method for forming the commissure tab assemblies and coupling them to the frame are disclosed in U.S. Patent No. 9,393,110, which is incorporatedby reference herein. It should be noted that FIGS. 3-5 show one exemplary technique for coupling the commissures of a leaflet assembly to a frame. Other techniques, methods, and mechanisms can be used for coupling the commissure tab assemblies to the frame 112, such as any of those disclosed in U.S. Patent No. 9,393,110, U.S. Publication No. 2018 / 0325665, or PCT Publication No. WO 2021 / 202,172, each of which is incorporated by reference herein.

[0089] FIG. 6 is a side view of a radiopaque marker 170 and a flexible connector 324 (which is also referred to herein as a “fabric connector”) for a prosthetic heart valve, according to an example. In some examples, the flexible connector 324 is used place of the flexible connector 124 to form each commissure 122 of the valvular structure 114. The radiopaque marker 170 and / or the flexible connector 324 can be used with any of the exemplary prosthetic heart valves disclosed herein (for example, any one of prosthetic heart valves 100, 300). It should further be understood that the radiopaque marker 170 and / or the flexible connector 324 can be used with any implantable medical device (for example, a prosthetic heart valve docking device, a stent, any prosthetic medical device, etc.).

[0090] The radiopaque marker 170 can be configured to be at least partially opaque or otherwise visible under fluoroscopy and / or any other medical imaging technique (for example, computed tomography (CT) scanning, magnetic resonance imaging (MRI), plain radiography, ultrasound imaging, etc.). Additionally, the radiopaque marker 170 can be fixedly attached to a portion of the prosthetic heart valve. In this way, the radiopaque marker 170 can beneficially help a user (for example, a user of a delivery apparatus) determine a position or orientation of the prosthetic heart valve relative to a subject’s native anatomy, a guidewire extending through the delivery apparatus, a prosthetic medical device (for example, a docking device, a previously-implanted prosthetic heart valve, etc.), and / or any other feature during a prosthetic heart valve implantation procedure. For example, the radiopaque marker 170 can be fixedly attached to any combination of a frame (for example, the frame 112), the commissure 122, a flexible connector (for example, flexible connector 124, flexible connector 324, flexible connector 424, etc.), a portion of a leaflet (for example, the lower tab 142 and / or the upper tab 144 of the leaflet 140), a skirt (for example, inner skirt 116, outer skirt 118, etc.), and / or any other portion of the prosthetic heart valve. As the user rotates the prosthetic heart valve in a circumferential direction (about an axis extending between a proximal end and a distal end of the delivery apparatus and / or prosthetic heart valve), the radiopaque marker 170 can rotate in unison with the rest of the prosthetic heart valve and provide the user with a target that is visible under fluoroscopy. The user can then determine, based on the visualized circumferentialposition or orientation of the radiopaque marker 170, a circumferential position or orientation of the prosthetic heart valve. In this example, since the radiopaque marker 170 is directly attached to a portion prosthetic heart valve instead of the delivery apparatus, the user does not need to mount the prosthetic heart valve onto the delivery apparatus in a specific, predetermined orientation prior to implantation, thereby simplifying the implantation procedure. Moreover, once implanted, the radiopaque marker 170 can serve as landmark on a host valve for positioning a guest valve at a specified orientation with respect to the host valve. For example, if one or more radiopaque markers 170 are positioned at one or more of the commissures of a host valve, the commissures of the guest valve (also having one or more radiopaque markers 170), can be aligned with the commissures of the host valve in a valve-in- valve procedure.

[0091] The radiopaque marker 170 can be fixedly attached to any portion of the prosthetic heart valve, including but not limited to any combination of the frame (for example, the frame 1 12), one of the commissure tab assemblies, the flexible connector (for example, flexible connector 124, flexible connector 324, or flexible connector 424), at least a portion of one or more of the leaflets (for example, the lower tabs 142, the upper tabs 144, and / or any other portion of the leaflets 140), the inner skirt (for example, the inner skirt 116), the outer skirt (for example, the outer skirt 118), and / or any other portion of the prosthetic heart valve.

[0092] For example, as shown in FIG. 6, the radiopaque marker 170 can be attached to the flexible connector 324. The flexible connector 324 can subsequently be coupled to the leaflets 140 and attached to the frame 112 in order to form the commissure 122. In other words, the radiopaque marker 170 can be attached to the commissure 122. In some examples, fixedly attaching the radiopaque marker 170 to the commissure 122 or adjacent the commissure 122 can help the user better determine the circumferential position or orientation of the commissures 122. Thus, in some examples, by helping the user determine the orientation of the prosthetic heart valve’s commissures 122, the radiopaque marker 170 can help the user better align the prosthetic heart valve’s commissures 122 to be circumferentially offset from the subject’s coronary arteries and / or the commissures of a host valve.

[0093] As shown, the radiopaque marker 170 optionally comprises at least one hole 172 that extends in a radial direction of the prosthetic heart valve. The at least one hole 172 can be configured to receive a suture 177 therethrough. The suture can be used to fixedly attach the radiopaque marker 170 to the flexible connector 324 and / or any other portion of the prosthetic heart valve. As shown, the radiopaque marker 170 comprises six holes 172 arranged into twolongitudinally-extending columns. However, the radiopaque marker 170 can comprise any number of holes 172 in any arrangement. Although the radiopaque marker 170 is illustrated as including holes 172 for the suture, it should be understood that the radiopaque marker 170 can be fixedly attached to the flexible connector 324 (or any other portion of the prosthetic heart valve) using any method and / or mechanism, including but not limiting to adhesives, metal fasteners (for example, staples), ultrasonic welding, etc.

[0094] The radiopaque marker 170 can have a different opacity under fluoroscopy than another portion of the prosthetic heart valve. For example, the radiopaque marker 170 can be more opaque than the rest of the prosthetic heart valve (including the frame 112) when visualized under fluoroscopy in order to provide the user with a more visible target that is easier to identify and / or track during the implantation procedure.

[0095] The radiopaque marker 170 can be formed from any radiopaque material. In some examples, the radiopaque marker 170 can be formed from a radiopaque metal, including but not limited to tantalum, gold, and / or platinum iridium. In some examples, the radiopacity of the radiopaque material can be greater than the radiopacity of any one of the other materials used to form the prosthetic heart valve (for the example, the materials forming any one of the frame 112, the valvular structure 114, the inner skirt 116, the outer skirt 118, etc.) to provide a more visible target under fluoroscopy. In other words, the radiopaque marker 170 can have a greater radiopacity than any of the frame 112, the valvular structure 114, the inner skirt 116, the outer skirt 1 18, etc.

[0096] It should be understood that although the opacity of the radiopaque marker 170 is primarily discussed herein with respect to fluoroscopy, it should be understood that the radiopaque marker 170 can additionally or alternatively be configured to be more opaque and / or visible under any medical imaging method used in a medical procedure (for example, computed tomography (CT) scanning, magnetic resonance imaging (MRI), plain radiography, ultrasound imaging, etc.).

[0097] In some examples, the radiopaque marker 170 can optionally be asymmetric about a central longitudinal axis 174 of the radiopaque marker 170. The central longitudinal axis 174 can be parallel to a longitudinal axis of the prosthetic heart valve (for example, an axis extending between the proximal and distal ends of the prosthetic heart valve). For example, as shown, the radiopaque marker 170 can have an asymmetric E-shape. The central longitudinal axis 174 can bisect the radiopaque marker 170 such that a first circumferential portion of theE-shape on a first side of the central longitudinal axis 174 and a second circumferential portion of the E-shape on a second, other side of the central longitudinal axis 174 have different shapes. The asymmetry of the radiopaque marker 170 can further help the user determine the relative circumferential orientation or position of the radiopaque marker 170. For example, the E-shape can face forwards (“E”) when the radiopaque marker 170 is facing in a circumferential direction that is relatively closer to a fluoroscopy screen than an X-ray source (“in the front plane of the fluoroscope image”) and can face backwards (“3”) when the radiopaque marker 170 is facing in a circumferential direction that is relatively farther away from the fluoroscopy screen and closer to the X-ray source (“in the back plane of the fluoroscope image”). Thus, the user can more easily determine, based on the direction of the visualization of the E-shape, whether the radiopaque marker 170 is in the front plane or back plane of the fluoroscope image. Although the asymmetric radiopaque marker 170 is shown as having the E-shape, the asymmetric radiopaque marker 170 can have a C-shape, an arrow shape, or any other shape that is asymmetric about the central longitudinal axis 174.

[0098] The flexible connector 324 can include opposing end portions 326 (which are also referred to herein as “side portions” and / or “circumferential side portions”) disposed on either side of a central portion 328. As shown, the radiopaque marker 170 is configured to be fixedly attached (for example, sutured) to the central portion 328. One exemplary difference between the flexible connector 324 — shown in an unfolded configuration in FIG. 6 — and the flexible connector 124 is that the flexible connector further includes a flap 329 that extends from a lower edge of the central portion 328 in a direction that is perpendicular to both opposing end portions 326 (for example, towards an upper edge of the central portion 328). The flexible connector 324 can be folded from an unfolded configuration (best shown in FIG. 6) to a folded configuration (best shown in FIG. 7) by folding the flap 329 in the direction of arrow 176 to cover the radiopaque marker 170. In another example, the flap 329 can extend from the upper edge of the central portion 328 and can be folded downwardly to cover the radiopaque marker 170. In some examples, folding the flap 329 over the radiopaque marker 170 can beneficially further minimize contact between the radiopaque marker 170 and the subject’s native anatomy and / or a previously implanted prosthetic medical device. In such examples, the flexible connector 324 can be used in lieu of the flexible connector 124. In some examples, the commissure 122 of a prosthetic valve can be assembled and mounted to the frame 112 using the flexible connector 324 instead of the flexible connector 124 in the same manner shown in FIGS. 4-5, with the addition of connecting the radiopaque marker 170 to the flexible connector324 (such as with sutures 177) and folding the flap. In other examples, each radiopaque marker 170 of the prosthetic valve can be mounted to a flexible connector without a flap, such as the flexible connector 124.

[0099] As shown in FIG. 6, the flexible connector 324 optionally includes one or more holes 327 configured to receive the sutures 177 that secure the radiopaque marker 170 to the flexible connector 324.

[0100] FIG. 7 is a side view of the flexible connector 324 shown in the folded configuration. As shown, the flap 329 is secured to the central portion 328 of the flexible connector 324 using sutures 178. As shown, the sutures 178 are sewn in a whip stich pattern along each circumferential side of the flap 329 in a vertical direction, but it should be understood that the suture 178 can be sewn in any stitching pattern. In some examples, the sutures 178 can additionally or alternatively be sewn along a side of the central portion 328 furthest from or opposite the flap 329. In some examples, the sutures 178 can extend through one or more of the holes 172 in the radiopaque marker 170 in order to secure the radiopaque marker 170 to the flexible connector 324. In some examples, sutures 152 can be used to secure the flap 329 to the central portion 328 of the flexible connector 324. Although the illustrated example shows sutures 178, it should be understood that any method and / or mechanism, including but not limiting to adhesives, metal fasteners (for example, staples), ultrasonic welding, etc., can be used to secure the flap 329 to the central portion 328. Additionally, any of these connection means can be to secure the marker 170 to the flexible connector 324 in lieu of or in addition to the sutures 177.

[0101] Although FIGS. 6-7 illustrate the radiopaque marker 170 being used in conjunction with the flexible connector 324, it should be understood that the radiopaque marker 170 can be implemented without the flexible connector 324. For example, the marker 170 can be fixedly attached (such as with sutures 177) to the leaflet material of the commissure 122 outside of the frame 112, such as by attaching the radiopaque marker 170 to the pair of lower tab portions 142. In some such examples, the flexible connector 124 or flexible connector 324 may not be used to form the commissure 122. In some examples, the radiopaque marker 170 can be positioned radially outside of the pair of lower tab portions 142 and radially inside of the flexible connector 124.

[0102] FIG. 8 is a side view of a prosthetic heart valve 300, according to an example. The prosthetic heart valve 300 includes the frame 1 12, the valvular structure 114, the inner skirt116, and the outer skirt 118. One exemplary difference between the prosthetic heart valve 300 and the prosthetic heart valve 100 is that the prosthetic heart valve 300 includes the radiopaque marker 170 mounted to a corresponding commissure 122 formed by the valvular structure 114. As shown, the radiopaque marker 170 is disposed adjacent the commissure 122 in a radially outwards direction. As previously discussed, mounting the radiopaque marker 170 to the commissure 122 helps the user better determine the location of the commissure 122 under fluoroscopy. Although only one radiopaque marker 170 is shown, it should be understood that the prosthetic valve 300 can include a plurality of radiopaque markers arranged in any pattern.

[0103] FIG. 9 is a side view of a portion of a prosthetic heart valve 400, similar to the exemplary prosthetic heart valve 300 shown in FIG. 5. In the prosthetic valve 400, the flexible connector 324 replaces the flexible connector 124. In some examples, the prosthetic valve 400 otherwise can have all of the same components of the prosthetic valve 100. As shown, the radiopaque marker 170 (whose outline is indicated by the dashed line) is covered by the flap 329 of the flexible connector 324. In some examples, a radiopaque marker 170 is positioned at each commissure 122 of the prosthetic heart valve 300. Thus, for a prosthetic valve having three leaflets and three commissures, the prosthetic valve has three radiopaque markers. In some examples, the prosthetic valve can have a marker 170 mounted to at least one of the commissures, while one or more of the commissures can be without a marker 170.

[0104] FIG. 10 is a side view of an asymmetric radiopaque marker 270, according to an example. The radiopaque marker 270, which in some examples can be similar to the radiopaque marker 170 shown best in FIG. 6, can be configured to be at least partially opaque or otherwise visible under fluoroscopy and / or any other medical imaging technique (for example, computed tomography (CT) scanning, magnetic resonance imaging (MRI), plain radiography, ultrasound imaging, etc.). Additionally, the radiopaque marker 270 can be fixedly attached to a portion of a prosthetic heart valve (for example, a commissure of a prosthetic heart valve). As shown, the radiopaque marker 270 comprises at least one hole 272 (which in some examples can be similar to the at least one hole 172 of the radiopaque marker 170) configured to receive a suture 177 (shown best in FIG. 13) and a central longitudinal axis 274 (which in some examples can be similar to the central longitudinal axis 174 of the radiopaque marker 170).

[0105] One exemplary difference between the radiopaque marker 270 and the radiopaque marker 170 is that the radiopaque marker 270 can further include at least one notch 279 (which is also referred to herein as an “alignment feature”). The at least one notch 279 can be a featureon the radiopaque marker 270 configured to help the user align the radiopaque marker 270 and / or the rest of the prosthetic heart valve with the guidewire extending through the delivery apparatus and / or the delivery apparatus.

[0106] For example, as shown, the radiopaque marker 270 includes two notches 279 (for example, a first notch 279 at a proximal end portion of the radiopaque marker 270 and a second notch 279 at a distal end portion of the radiopaque marker 270) that are aligned in a vertical direction of the radiopaque marker 270 and / or aligned along the central longitudinal axis 274. Aligning the guidewire and / or delivery apparatus to overlap both notches 279 can help the user ensure that the central longitudinal axis 274 of the radiopaque marker 270 and / or a longitudinal axis of the prosthetic heart valve are parallel with a longitudinal axis of the guidewire and / or the delivery apparatus. In some examples, the alignment feature(s) can take other forms, such as a protrusion that extends from the proximal edge of the marker 270 (the upper edge in FIG. 10) and / or a protrusion that extends from the distal edge of the marker 270 (the lower edge in FIG. 10). It should be understood that the radiopaque marker 270 and the radiopaque marker 170 are interchangeable such that the radiopaque marker 270 can be used in any example described herein instead of the radiopaque marker 170.

[0107] In some examples, the notches 279 can be used to rotationally align a commissure 122 of the prosthetic valve (for example, prosthetic valve 400) with a native commissure of the native aortic valve. For example, using a standard three-cusp imaging view under fluoroscopy, a delivery apparatus with the prosthetic valve in a radially compressed state on the delivery apparatus can be advanced over a guidewire, which extends through the native aortic valve. In the three-cusp imaging view, the guidewire can be aligned with a native commissure in the back of the imaging view (such as the native commissure between the non-coronary cusp and the left coronary cusp). The radiopaque marker 270 on the prosthetic valve is aligned with the guidewire such that the guide wire intersects or overlaps the notches 279, such as by rotating a handle of the delivery apparatus that is effective to rotate the prosthetic valve relative to the guidewire. Aligning the notches 279 with the guidewire is effective to rotationally align the marker 270 with the native commissure. In some examples, the alignment step is performed prior to advancing the prosthetic valve across the native aortic valve. In some examples, the alignment step is performed after advancing the prosthetic valve across the native aortic valve. In either case, after positioning the prosthetic valve within the native aortic valve, the prosthetic valve can be radially expanded (such as by inflating a balloon of the delivery apparatus) to a radially expanded state in engagement with the native valve such that the commissure 122 ofthe prosthetic having the marker 270 is aligned with the native commissure. In some examples, the notches 279 on the marker 270 can be aligned with the guide wire after partially expanding the prosthetic valve. Further details regarding a procedure for aligning a radiopaque marker with a guidewire can be found in PCT Publication No. WO2022 / 046585, which is incorporated by reference herein.

[0108] FIG. 11 is a side view of a flexible connector 424 for a prosthetic heart valve, according to an example, wherein the flexible connector 424 is shown in an unfolded configuration. The flexible connector 424 (which is also referred to herein as a “fabric connector”) can include a central portion 428 (which in some examples can be similar to the central portion 328 of the flexible connector 324), circumferential side portions 426 (which in some examples can be similar to end portions 326 of the flexible connector 324) that extend in opposing circumferential directions from the central portion 428, one or more holes 427 (which in some examples can be similar to holes 327 of the flexible connector 324) formed in the central portion 428, and a flap 429. One exemplary difference between the flexible connector 424 and the flexible connector 324 is that the flap 429 (which is also referred to herein as a “side flap” and / or a “circumferential flap”) can extend in a circumferential direction from any one of the side portions 426 instead of extending in a vertical direction from the central portion 428. The flexible connector 424 is shown in the unfolded configuration, in which the flap 429 is not folded over the central portion 428 and / or the side portions 426. The flexible connector 424 can be used to form any valvular structure (for example, valvular structure 114) described herein. It should be understood that the flexible connector 424 and the flexible connector 324 are interchangeable such that the flexible connector 424 can be used in any example herein instead of the flexible connector 324.

[0109] FIG. 12 is a perspective view of the flexible connector 424 attached to the frame 112 of a prosthetic heart valve 500 and shown in a partially assembled state, according to an example. As shown, the flap 429 extends in a circumferential direction of the prosthetic heart valve 500 from the commissure 122 of the prosthetic heart valve 500. FIG. 15 is a cross- sectional view taken through a commissure window 132 showing the flexible connector 424 used to form a commissure 122. The commissure 122 in FIGS. 12 and 15 can be formed in a manner similar to that shown in FIG. 4, except that after stitching the flexible connector 424 to the lower tabs 142 of the leaflet, inserting portions of the lower tabs 142 and the flexible connector 424 through the commissure window 132, and forming stitches 146, 148, 158, the flap 429 extends from one side of the commissure window 132.

[0110] After partially forming the commissure 122 with the flap 429 extending from the commissure window 142, the radiopaque marker 170 can be coupled to the flap, as shown in FIG. 13. Specifically, FIG. 13 shows the radiopaque marker 170 coupled to the flap 429 of the flexible connector 424 using the suture 177. As shown, the suture 177 is inserted through one or more of the holes 172 of the radiopaque marker 170 to secure the radiopaque marker 170 to the flap 429 of the flexible connector 424. In some examples, the radiopaque marker 170 can instead be secured to the central portion 428 of the flexible connector 424, the circumferential side portions 426 of the flexible connector 424, and / or any other portion of the flexible connector 424.

[0111] After stitching or otherwise coupling the radiopaque marker 170 to the flap 429, the flap 429 can be folded into a folded configuration, as shown in FIG. 14. In the folded configuration, the flap 429 can be configured to cover the radiopaque marker 170, which is positioned between two layers of the flexible connector 424. In some examples, folding the flap 429 to place the radiopaque marker 170 between two layers of the flexible connector 424 can beneficially further minimize contact between the radiopaque marker 170 and the subject’ s native anatomy and / or a previously implanted prosthetic medical device.

[0112] As shown, the flap 429 can be folded over the central portion 428 and secured thereto using sutures 178. In some examples, such as the illustrated example, the sutures 178 can additionally be used to secure the flap 429 to the central portion 428, thereby eliminating the need for sutures 177. Optional stitches (such as whip stitches) can be formed along one or both of the opposing sides of the flap 429 to secure the flap 429 to the central portion 428 of the flexible connector 424 and / or to outer portions 156 of the upper tabs 144. Although the illustrated example shows sutures 178, it should be understood that any method and / or mechanism, including but not limiting to adhesives, metal fasteners (for example, staples), ultrasonic welding, etc., can be used. Additionally, any of these connection means can be to secure the radiopaque marker 170 to the flexible connector 424 in lieu of or in addition to the sutures 177.Example Delivery Apparatus

[0113] FIG. 2 shows a delivery apparatus 200, according to an example, in the form of a balloon catheter that can be used to implant a prosthetic medical device. In some examples, the delivery apparatus 200 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 valvesdescribed herein). In some examples, the delivery apparatus 200 is specifically adapted for use in introducing a prosthetic heart valve into a heart.

[0114] The delivery apparatus 200 in the illustrated example of FIG. 2 comprises 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.

[0115] 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 heart valve at an implantation site in a patient’s body.

[0116] 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.

[0117] 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.

[0118] 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 catheter balloon 218 (which also referred to herein as a “balloon”) 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.

[0119] The catheter balloon 218 can be coupled to the distal end portion of the intermediate shaft 206.

[0120] In some examples, a distal end of the catheter 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. 2), or to analternate component at the distal end of the delivery apparatus 200 (for example, a distal shoulder). An intermediate portion of the catheter 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 catheter balloon 218 can overly a distal shoulder 226 of the delivery apparatus 200. The valve mounting portion 224 and the intermediate portion of the catheter balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 2, a prosthetic heart valve 250 (which can be one of the prosthetic heart valves described herein) can be mounted around the catheter balloon 218, at the valve mounting portion 224 of the delivery apparatus 200.

[0121] The balloon shoulder assembly, including the distal shoulder 226, is configured to maintain the prosthetic heart valve 250 (or other prosthetic medical device) at a fixed position on the catheter balloon 218 during delivery through the patient’s vasculature.

[0122] 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 heart valve 250 is mounted in the radially compressed state on the valve mounting portion 224 (as shown in FIG. 2) and during delivery of the prosthetic heart valve to the target implantation site. As such, the distal tip portion 228 can be configured to resist movement of the prosthetic heart valve 250 relative to the catheter balloon 218 proximally, in the axial direction, relative to the catheter balloon 218, when the distal tip portion 228 is arranged adjacent to a proximal side of the valve mounting portion 224.

[0123] 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 catheter balloon 218. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the catheter balloon 218 and radially expand and deploy the prosthetic heart valve 250.

[0124] 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.

[0125] 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.

[0126] 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.Delivery Techniques

[0127] 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 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 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 self-expand). 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 aortic valve. 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-sternotomy orright parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0128] 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.

[0129] 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 / pulmonary artery.

[0130] 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.

[0131] 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.

[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.

[0133] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with the body parts, tissue, etc. being simulated), etc.Additional Examples of the Disclosed Technology

[0134] 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.

[0135] Example 1. A prosthetic heart valve can include a frame that can include a plurality of struts that can form a plurality of commissure windows spaced circumferentially apart around the frame; a valvular structure coupled to the frame; a commissure formed by the valvular structure, wherein the commissure can be secured to a respective one of the plurality of commissure windows; and a radiopaque marker fixedly attached to the commissure.

[0136] Example 2. The prosthetic heart valve of any example herein, particularly example 1, wherein the valvular structure can include: a first leaflet that can include a first tab; a second leaflet that can include a second tab; and a flexible connector secured to each one of the first tab and the second tab, wherein the first tab, the second tab, and a portion of the flexible connector can extend through the commissure window, and wherein the first leaflet, the second leaflet, and the flexible connector can form the commissure.

[0137] Example 3. The prosthetic heart valve of any example herein, particularly example 2, wherein the radiopaque marker can be fixedly attached to the flexible connector outside of the frame.

[0138] Example 4. The prosthetic heart valve of any example herein, particularly example 3, wherein the radiopaque marker can be sutured to the flexible connector.

[0139] Example 5. The prosthetic heart valve of any example herein, particularly any one of examples 3-4, wherein the flexible connector can include: a first end portion; a second end portion opposite the first end portion; and a central portion disposed between the first end portion and the second end portion, wherein the radiopaque marker can be fixedly attached to the central portion of the flexible connector.

[0140] Example 6. The prosthetic heart valve of any example herein, particularly example5, wherein the flexible connector can include a flap extending from the central portion in a direction that is perpendicular to both the first end portion and the second end portion.

[0141] Example 7. The prosthetic heart valve of any example herein, particularly example6, wherein the flap can be folded over the central portion of the flexible connector and can cover the radiopaque marker.

[0142] Example 8. The prosthetic heart valve of any example herein, particularly any one of examples 6-7, wherein the flap can be secured to the central portion by sutures.

[0143] Example 9. The prosthetic heart valve of any example herein, particularly example 8, wherein the sutures can be arranged in a whip stitch patten.

[0144] Example 10. The prosthetic heart valve of any example herein, particularly any one of examples 8-9, wherein the sutures can extend in a vertical direction along a first circumferential side of the flap and a second circumferential side of the flap.

[0145] Example 11. The prosthetic heart valve of any example herein, particularly any one of examples 1-10, wherein the radiopaque marker can include a central longitudinal axis, and wherein the radiopaque marker can be asymmetric about the central longitudinal axis.

[0146] Example 12. A prosthetic heart valve can include: an annular frame including at least one window frame portion; a first leaflet and a second leaflet, wherein the first leaflet and the second leaflet can be secured to one another at their adjacent sides to form a commissure that is coupled to the at least one window frame portion of the annular frame; and a radiopaque marker coupled to the commissure outside of the annular frame.

[0147] Example 13. The prosthetic heart valve of any example herein, particularly example 12, wherein the radiopaque marker can include a central longitudinal axis, and wherein the radiopaque marker can be asymmetric about the central longitudinal axis.

[0148] Example 14. The prosthetic heart valve of any one of claims 12-13, wherein the radiopaque marker can have an E-shape.

[0149] Example 15. The prosthetic heart valve of any example herein, particularly any one of examples 12-13, wherein the radiopaque marker can have a C-shape.

[0150] Example 16. The prosthetic heart valve of any example herein, particularly any one of examples 12-15, wherein the radiopaque marker can include at least one hole extending through the radiopaque marker.

[0151] Example 17. The prosthetic heart valve of any example herein, particularly example 16, wherein the at least one hole can include a plurality of holes arranged in at least one column extending in a longitudinal direction of the prosthetic heart valve.

[0152] Example 18. The prosthetic heart valve of any example herein, particularly any one of examples 12-17, wherein the radiopaque marker can be formed from a radiopaque metal.

[0153] Example 19. The prosthetic heart valve of any example herein, particularly example 18, wherein the radiopaque marker can be formed from tantalum.

[0154] Example 20. The prosthetic heart valve of any example herein, particularly example 18, wherein the radiopaque marker can be formed from gold.

[0155] Example 21. The prosthetic heart valve of any example herein, particularly example 18, wherein the radiopaque marker can be formed from platinum iridium.

[0156] Example 22. The prosthetic heart valve of any example herein, particularly any one of examples 12-21, wherein the radiopaque marker can have a greater radiopacity than the annular frame, the first leaflet, and the second leaflet.

[0157] Example 23. A method can include: securing a first tab of a first leaflet to a first end portion of a flexible connector; securing a second tab of a second leaflet to a second end portion of the flexible connector, wherein the first end portion can be opposite the second end portion; inserting at least a portion of the first tab, at least a portion of the second tab, and at least a portion of the flexible connector though a commissure window of a radially compressible and expandable frame to form a commissure; and coupling a radiopaque marker to the commissure.

[0158] Example 24. The method of any example herein, particularly example 23, wherein: the flexible connector can include a central portion disposed between the first end portion and the second end portion and a flap extending from the central portion in a direction perpendicular to both the first end portion and the second end portion, and the method can further include, after coupling a radiopaque marker to the commissure, folding the flap to cover the radiopaque marker.

[0159] Example 25. The method of any example herein, particularly example 24, which can further include, after folding the flap to cover the radiopaque marker, suturing the flap to the central portion of the flexible connector.

[0160] Example 26. The method of any example herein, particularly example 25, wherein the flap can be sutured to the central portion using whip stitches.

[0161] Example 27. The method of any example herein, particularly any one of examples 25-26, wherein the flap can be sutured to the central portion along at least one of a first circumferential side of the flap and a second circumferential side of the flap.

[0162] Example 28. The method of any example herein, particularly any one of examples 24-27, wherein coupling the radiopaque marker to the commissure can include coupling the radiopaque marker to the central portion of the flexible connector.

[0163] Example 29. The method of any example herein, particularly any one of examples 23-28, wherein the radiopaque marker can include a central longitudinal axis, and wherein the radiopaque marker is asymmetric about the central longitudinal axis.

[0164] Example 30. A method can include: mounting a prosthetic medical device to a distal end portion of a delivery apparatus, wherein the prosthetic medical device can include a frame, at least one commissure, and a radiopaque marker coupled to the at least one commissure outside of the frame; advancing the prosthetic medical device and the distal end portion of the delivery apparatus through a subject’s vasculature to an implantation site; and visualizing the radiopaque marker under fluoroscopy to determine a circumferential position of the prosthetic medical device relative to the implantation site.

[0165] Example 31. The method of any example herein, particularly example 30, wherein the implantation site can be a native aortic annulus.

[0166] Example 32. The method of any example herein, particularly example 31, wherein visualizing the radiopaque marker under fluoroscopy can include determining a circumferentialposition of the radiopaque marker relative to at least one coronary artery adjacent the native aortic annulus.

[0167] Example 33. The method of any example herein, particularly any one of examples 30- 32, wherein the prosthetic medical device can be a prosthetic heart valve.

[0168] Example 34. The method of any one of claims 30-34, wherein the radiopaque marker is asymmetric about a central longitudinal axis of the radiopaque marker.

[0169] Example 35. The method of any example herein, particularly example 34, wherein visualizing the radiopaque marker under fluoroscopy can include determining, based on a direction of the visualization of the radiopaque marker, whether the radiopaque marker is in a front plane or a back plane of a fluoroscope image.

[0170] Example 36. The method of any example herein, particularly any one of examples 30- 35, wherein mounting a prosthetic medical device to a distal end portion of a delivery apparatus can not require the prosthetic medical device to be mounted in a specific circumferential orientation relative to the distal end portion of the delivery apparatus in order to determine the circumferential position of the prosthetic medical device relative to the implantation site.

[0171] Example 37. The method of any example herein, particularly any one of examples 30-36, wherein the radiopaque marker can include at least one alignment feature, and the method can further include aligning the at least one alignment feature with a guidewire under fluoroscopy.

[0172] Example 38. A prosthetic heart valve can include a frame including a plurality of struts, a valvular structure coupled to the frame, wherein the valvular structure can include a flexible connector that includes a central portion, a first side portion extending in a first circumferential direction from the central portion, a second side portion extending in a second circumferential direction from the central portion, and a flap extending in the first circumferential direction from the first side portion, and a radiopaque marker fixedly attached to the flexible connector.

[0173] Example 39. The prosthetic heart valve of any example herein, particularly example 38, wherein the radiopaque marker can be fixedly attached to the flap of the flexible connector.

[0174] Example 40. The prosthetic heart valve of any example herein, particularly any one of examples 38-39, wherein the radiopaque marker can include at least one alignment feature configured to help a user align the radiopaque marker with a guidewire.

[0175] Example 41. The prosthetic heart valve of any example herein, particularly example 40, wherein the at least one alignment feature can include at least one notch.

[0176] Example 42. The prosthetic heart valve of any example herein, particularly any one of examples 40-41, wherein the at least one alignment feature can include a first alignment feature disposed at a proximal end portion of the radiopaque marker and a second alignment feature disposed at a distal end portion of the radiopaque marker.

[0177] Example 43. The prosthetic heart valve of any example herein, particularly example 42, wherein the first alignment feature and the second alignment feature can each be aligned with a central longitudinal axis of the radiopaque marker.

[0178] Example 44. A prosthetic heart valve can include: a frame including a plurality of struts; a valvular structure coupled to the frame; a commissure formed by the valvular structure; and a radiopaque marker positioned at the commissure and having at least one alignment feature for aligning with a guidewire.

[0179] Example 45. The prosthetic heart valve of any example herein, particularly example 44, wherein the least one alignment feature can be positioned along a longitudinal axis bisecting the radiopaque marker.

[0180] Example 46. The prosthetic heart valve of any example herein, particularly any one of examples 44-45, wherein the at least one alignment feature can include a first alignment feature on a proximal end of the radiopaque marker and a second alignment feature on a distal end of the radiopaque marker.

[0181] Example 47. The prosthetic heart valve of any example herein, particularly any one of examples 44-46, wherein the at least one alignment feature can include a notch.

[0182] Example 48. The prosthetic heart valve of any example herein, particularly any one of examples 44-47, wherein the radiopaque marker can be asymmetric.

[0183] Example 49. The prosthetic heart valve of any example herein, particularly any one of examples 44-48, wherein the commissure can include a portion that extends through a commissure window of the frame and the radiopaque marker can be affixed to the commissure outside of the frame.

[0184] Example 50. The prosthetic heart valve of any example herein, particularly any one of examples 44-49, wherein the radiopaque marker can be affixed to a fabric connector of the commissure.

[0185] Example 51. A method can include: mounting a prosthetic heart valve to a distal end portion of a delivery apparatus, wherein the prosthetic heart valve can include a frame, at least one commissure, and a radiopaque marker coupled to the at least one commissure, wherein the radiopaque marker can include at least one alignment feature; advancing the prosthetic heart valve and the distal end portion of the delivery apparatus over a guidewire and through a subject’s vasculature to an implantation site; and under fluoroscopy, visualizing the radiopaque marker and the guidewire and aligning the at least one alignment feature of the radiopaque marker with the guidewire.

[0186] Example 52. The method of any example herein, particularly example 51, wherein the implantation site can be a native aortic annulus.

[0187] Example 53. The method of any example herein, particularly example 52, wherein aligning the at least one alignment feature of the radiopaque marker with the guidewire can be effective to align the radiopaque marker with a native commissure of a native aortic valve.

[0188] Example 54. The method of any example herein, particularly example 53, wherein the act of visualizing can include visualizing the radiopaque marker and the guidewire in a three-cusp imaging view.

[0189] Example 55. The method of any example herein, particularly any one of examples 51-54, wherein the radiopaque marker can be asymmetric about a central longitudinal axis of the radiopaque marker.

[0190] Example 56. The method of any example herein, particularly any one of examples 51-55, wherein visualizing the radiopaque marker under fluoroscopy can include determining, based on a direction of the visualization of the radiopaque marker, whether the radiopaque marker is in a front plane or a back plane of a fluoroscope image.

[0191] Example 57. The method of any example herein, particularly any one of examples 51-56, wherein the at least one alignment feature can include at least one notch.

[0192] Example 58. The method of any example herein, particularly example 57, wherein the at least one notch can include a first notch formed on a proximal edge of the radiopaque marker and a second notch formed on a distal end of the radiopaque marker.

[0193] 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 any other prosthetic heart valve. As another example, any one or more features of one radiopaque marker can be combined with any one or more features of another radiopaque marker. As another example, any one or more features of one flexible connector can be combined with any one or more features of another flexible connector.

[0194] 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

Claims1. A prosthetic heart valve comprising: a frame comprising a plurality of struts that form a plurality of commissure windows spaced circumferentially apart around the frame; a valvular structure coupled to the frame; a commissure formed by the valvular structure, wherein the commissure is secured to a respective one of the plurality of commissure windows; and a radiopaque marker fixedly attached to the commissure.

2. The prosthetic heart valve of claim 1 , wherein the valvular structure comprises: a first leaflet that includes a first tab; a second leaflet that includes a second tab; and a flexible connector secured to each one of the first tab and the second tab, wherein the first tab, the second tab, and a portion of the flexible connector extend through the commissure window, and wherein the first leaflet, the second leaflet, and the flexible connector form the commissure.

3. The prosthetic heart valve of claim 2, wherein the radiopaque marker is fixedly attached to the flexible connector outside of the frame.

4. The prosthetic heart valve of claim 3, wherein the radiopaque marker is sutured to the flexible connector.

5. The prosthetic heart valve of any one of claims 3-4, wherein the flexible connector comprises: a first end portion; a second end portion opposite the first end portion; and a central portion disposed between the first end portion and the second end portion, wherein the radiopaque marker is fixedly attached to the central portion of the flexible connector.

6. The prosthetic heart valve of claim 5, wherein the flexible connector comprises a flap extending from the central portion in a direction that is perpendicular to both the first end portion and the second end portion.

7. The prosthetic heart valve of claim 6, wherein the flap is folded over the central portion of the flexible connector and covers the radiopaque marker.

8. The prosthetic heart valve of any one of claims 1 -7, wherein the radiopaque marker comprises a central longitudinal axis, and wherein the radiopaque marker is asymmetric about the central longitudinal axis.

9. A method comprising: securing a first tab of a first leaflet to a first end portion of a flexible connector; securing a second tab of a second leaflet to a second end portion of the flexible connector, wherein the first end portion is opposite the second end portion; inserting at least a portion of the first tab, at least a portion of the second tab, and at least a portion of the flexible connector though a commissure window of a radially compressible and expandable frame to form a commissure; and coupling a radiopaque marker to the commissure.

10. The method of claim 9, wherein: the flexible connector comprises a central portion disposed between the first end portion and the second end portion and a flap extending from the central portion in a direction perpendicular to both the first end portion and the second end portion, and the method further comprises, after coupling a radiopaque marker to the commissure, folding the flap to cover the radiopaque marker.

11. The method of claim 10, further comprising, after folding the flap to cover the radiopaque marker, suturing the flap to the central portion of the flexible connector.

12. The method of claim 11, wherein the flap is sutured to the central portion using whip stitches.

13. The method of any one of claims 11-12, wherein the flap is sutured to the central portion along at least one of a first circumferential side of the flap and a second circumferential side of the flap.

14. The method of any one of claims 10-13, wherein coupling the radiopaque marker to the commissure comprises coupling the radiopaque marker to the central portion of the flexible connector.

15. The method of any one of claims 9-14, wherein the radiopaque marker comprises a central longitudinal axis, and wherein the radiopaque marker is asymmetric about the central longitudinal axis.

16. A method comprising: mounting a prosthetic medical device to a distal end portion of a delivery apparatus, wherein the prosthetic medical device includes a frame, at least one commissure, and a radiopaque marker coupled to the at least one commissure outside of the frame; advancing the prosthetic medical device and the distal end portion of the delivery apparatus through a subject’s vasculature to an implantation site; and visualizing the radiopaque marker under fluoroscopy to determine a circumferential position of the prosthetic medical device relative to the implantation site.

17. The method of claim 16, wherein the implantation site is a native aortic annulus, and wherein visualizing the radiopaque marker under fluoroscopy comprises determining a circumferential position of the radiopaque marker relative to at least one coronary artery adjacent the native aortic annulus.

18. The method of any one of claims 16-17, wherein the radiopaque marker is asymmetric about a central longitudinal axis of the radiopaque marker.

19. The method of claim 18, wherein visualizing the radiopaque marker under fluoroscopy comprises determining, based on a direction of the visualization of the radiopaque marker, whether the radiopaque marker is in a front plane or a back plane of a fluoroscope image.

20. The method of any one of claims 16-19, wherein: the radiopaque marker comprises at least one alignment feature, and the method further comprises aligning the at least one alignment feature with a guidewire under fluoroscopy.

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