Radiopaque plating of prosthetic heart valve frames

Abstract

Radiopaque plating for prosthetic heart valve frames is disclosed. A prosthetic heart valve can comprise a radially expandable and compressible annular frame and a plurality of leaflets arranged within the frame. The frame can comprise a plurality of struts arranged in rows and forming cells and commissure support portions. Selected struts of the plurality of struts, such as struts forming inlet rows of struts or cells, and / or regions of commissure support portions, can have radiopaque plating that is visible under fluoroscopy for alignment relative to anatomical landmarks within or adjacent the native heart valve. Also disclosed herein are methods of implanting a prosthetic heart valve comprising a frame with radiopaque plating within a native heart valve and methods of plating a prosthetic heart valve frame with a radiopaque material.

Description

THVVA-24038WO01RADIOPAQUE PLATING OF PROSTHETIC HEART VALVE FRAMESCROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 733,122, filed December 12, 2024, which is incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure relates to radiopaque plating of prosthetic heart valve frames.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 (e.g., 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.

[0004] In a 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 (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic 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 valve, or by deploying the prosthetic valve from a sheath of the delivery apparatus so that the prosthetic valve can self-expand to its functional size.

[0005] Many expandable prosthetic heart valves comprise a radially expandable and compressible annular metal frame or stent, prosthetic leaflets mounted inside the frame, and in some instances, outer skirts or seals secured to the frame. In some cases, separate alignment elements or markers with radiopaque properties can be attached to portions of the prosthetic valve or the delivery apparatus. These radiopaque alignment markers can beTHVVA-24038WO01visible under guided fluoroscopy when inside a body and can be used to spatially orient an axial and radial position of the prosthetic valve during delivery at an implantation site with respect to the native valve and / or surrounding anatomy.

[0006] In some examples, attachment of separate alignment markers can increase the time and complexity of the manufacturing process. The addition of separate alignment markers to the prosthetic valve can also increase the crimp profile of the prosthetic valve.SUMMARY

[0007] Accordingly, a need exists for accurate and reliable radiopaque alignment features that can improve prosthetic valve alignment and decrease crimp profile and manufacturing costs.

[0008] Described herein are prosthetic heart valves, delivery apparatuses, and methods for implanting prosthetic heart valves. Also described herein are configurations and methods for radiopaque plating of prosthetic valve frames for prosthetic valve alignment within a native heart valve. The disclosed prosthetic heart valves, delivery apparatuses, radiopaque plating, and methods can, for example, allow for accurate deployment of a prosthetic valve while reducing manufacturing time and costs and / or decreasing the crimp profile of the prosthetic valve. In some cases, the radiopaque plating can be used to indicate the position of selected portions of the prosthetic valve frame for subsequent procedures, such as a valve-in-valve procedure or a procedure requiring access to a coronary artery. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatuses.

[0009] A prosthetic heart valve can comprise a radially expandable and compressible annular frame and a valvular structure comprising a plurality of leaflets coupled to the frame at a plurality of commissures. In addition to these components, a prosthetic heart valve can further comprise one or more of the components disclosed herein.

[0010] In some examples, a prosthetic heart valve frame can comprise a plurality of commissure support portions spaced circumferentially apart around the frame.

[0011] In some examples, the commissures can be supported by respective commissure support portions.

[0012] In some examples, at least a portion of at least one commissure support portion can have a radiopaque plating.THVVA-24038WO01

[0013] In some examples, the radiopaque plating can form a reflection asymmetric, radiopaque indicator at one or more of the plurality of commissure support portions.

[0014] In some examples, the commissure support portions can comprise commissure windows, wherein each commissure window can comprise a first axially extending commissure support strut, a second axially extending commissure support strut, a first circumferential strut connecting inflow end portions of the first and second axially extending commissure support struts, and a second circumferential strut connecting outflow end portions of the first and second axially extending commissure support struts, and wherein the first axially extending commissure support strut and at least one of the first circumferential strut and the second circumferential strut of at least one of the commissure windows can have the radiopaque plating.

[0015] In some examples, the first axially extending commissure support strut, the first circumferential strut, and the second circumferential strut of at least one of the commissure windows can have the radiopaque plating.

[0016] In some examples, the first axially extending commissure support strut, the first circumferential strut, and the second circumferential strut of each of the commissure windows can have the radiopaque plating.

[0017] In some examples, the commissure support portions can comprise commissure support cells formed by struts of the frame, and a portion of the struts of at least one of the commissure support cells can have the radiopaque plating.

[0018] In some examples, the commissure support cells can comprise a first angled outflow strut, a second angled outflow strut, a first angled inflow strut, and a second angled inflow strut, and wherein at least one of the first and second angled outflow struts and at least one of the first and second angled inflow struts can have the radiopaque plating.

[0019] In some examples, the radiopaque plating can be on only an exterior surface of the frame at the one or more of the plurality of commissure support portions.

[0020] In some examples, the radiopaque plating can comprise one or more of gold, platinum, tantalum, iridium, palladium, and rhodium.

[0021] In some examples, the frame can have a height extending from an inlet end to an outlet end of the frame, and an inlet portion of the frame can have a radiopaque plating.

[0022] In some examples, the radiopaque plating on the inlet portion can extend from the inlet end toward the outlet end for at least 20 percent of the height of the frame.THVVA-24038WO01

[0023] In some examples, the radiopaque plating on the inlet portion can extend from the inlet end toward the outlet end for at least 50 percent of the height of the frame.

[0024] In some examples, the radiopaque plating on the inlet portion can extend from the inlet end toward the outlet end for 5 to 50 percent of the height of the frame.

[0025] In some examples, the radiopaque plating can extend up to 80 percent of the height of the frame from the inlet end.

[0026] In some examples, the radiopaque plating can extend between 20-60 percent of the height of the frame from the inlet end.

[0027] In some examples, the radiopaque plating can extend between 30-50 percent of the height of the frame from the inlet end.

[0028] In some examples, the radiopaque plating can extend between 40-50 percent of the height of the frame from the inlet end.

[0029] In some examples, wherein the radiopaque plating can extend 50 percent of the height of the frame from the inlet end.

[0030] In some examples, the radiopaque plating can be on only an exterior surface of the frame along the inlet portion of the frame.

[0031] In some examples, the radiopaque plating can be on one or more of an exterior, an interior and / or a side surface of struts that form the inlet portion of the frame.

[0032] In some examples, the frame can further comprise a plurality of angled struts arranged in a plurality of circumferentially extending rows of angled struts forming at least one circumferentially extending row of cells defining an inlet end of the frame wherein at least a portion of the cells can have a radiopaque plating.

[0033] In some examples, the at least one circumferentially extending row of cells can comprise a first row of cells at the inlet end of the frame, and wherein every cell of the first row of cells can have the radiopaque plating.

[0034] In some examples, the at least one circumferentially extending row of cells can comprise a second row of cells adjacent the first row of cells, and wherein at least a portion of each cell of the second row of cells can have the radiopaque plating.

[0035] In some examples, the plurality of rows of angled struts can include a first row of angled struts at the inlet end of the frame, wherein the struts of the first row of angled struts can have radiopaque plating.THVVA-24038WO01

[0036] In some examples, a prosthetic heart valve comprises a radially expandable and compressible annular frame, wherein the frame comprises a plurality of commissure support portions spaced circumferentially apart around the frame; a plurality of leaflets arranged within the frame and forming a plurality of commissures supported by respective commissure support portions; and wherein at least a portion of at least one commissure support portion has a radiopaque plating.

[0037] In some examples, a prosthetic heart valve comprises a radially expandable and compressible annular frame, wherein the frame comprises a plurality of angled struts arranged in a plurality of circumferentially extending rows of angled struts forming at least one circumferentially extending row of cells defining an inlet end of the frame; and a plurality of leaflets disposed within the frame and configured to regulate a flow of blood through the frame in one direction from the inlet end of the frame to an outlet end of the frame, wherein at least a portion of the cells has a radiopaque plating.

[0038] In some examples, a prosthetic heart valve comprises a radially expandable and compressible annular frame having a plurality of struts comprising a first metal having a first radiopacity; a plurality of leaflets disposed within the frame and configured to regulate a flow of blood through the frame in one direction from an inlet end of the frame to an outlet end of the frame; and wherein one or more selected struts of the plurality of struts are plated with a second metal having a second radiopacity that is greater than the first radiopacity.

[0039] In some examples, a prosthetic heart valve comprises one or more of the components recited in Examples 1-27 and 78 below.

[0040] In some examples, an expandable frame for a prosthetic heart valve can comprise a plurality of struts comprising a first metal having a first radiopacity. In addition, an expandable frame for a prosthetic heart valve can further comprise one or more of the elements disclosed herein.

[0041] In some examples, one or more selected struts of the plurality of struts can be plated with a second metal having a second radiopacity that is greater than the first radiopacity.

[0042] In some examples, the first metal can be cobalt-chromium.

[0043] In some examples, the second metal can be gold or platinum.

[0044] In some examples, the one or more selected struts can form a circumferential arrangement of struts around the frame.THVVA-24038WO01

[0045] In some examples, the one or more selected struts can form at least one reflection asymmetric, radiopaque indicator.

[0046] In some examples, the reflection asymmetric, radiopaque indicator can form a C shape, a backwards C shape, an uppercase gamma shape, a backwards uppercase gamma shape, an L shape, or a backwards L shape when viewed from outside of the frame.

[0047] In some examples, the one or more selected struts can be plated with the second metal on only an exterior surface of the frame.

[0048] In some examples, the one or more selected struts can be plated with the second metal on all sides of the one or more selected struts.

[0049] In some examples, the one or more selected struts can have radiopaque plating on one or more of an exterior, an interior and / or a side surface of the one or more selected struts.

[0050] In some examples, the one or more selected struts can comprise struts that are configured as axially extending commissure supports forming portions of at least one commissure window.

[0051] In some examples, the one or more selected struts can comprise struts that are configured as commissure supports forming portions of at least one commissure support cell.

[0052] In some examples, the one or more selected struts can comprise struts that are configured as commissure supports and / or struts forming a row of cells at an inlet end of the frame.

[0053] In some examples, an expandable frame for a prosthetic heart valve comprises a plurality of struts comprising a first metal having a first radiopacity, wherein one or more selected struts are plated with a second metal having a second radiopacity that is greater than the first radiopacity.

[0054] In some examples, an annular, expandable frame for a prosthetic heart valve comprises a plurality of struts, wherein one or more selected struts of the plurality of struts has radiopaque plating.

[0055] In some examples, an expandable frame for a prosthetic heart valve comprises one or more of the elements recited in Examples 28-55 below.

[0056] In some examples, a method of implanting a prosthetic heart valve can comprise delivering the prosthetic heart valve to an implantation site at a native heart valve in a radially crimped configuration and expanding the prosthetic heart valve into a radially expandedTHVVA-24038WO01configuration at the implantation site. In addition to these steps, a method of implanting a prosthetic heart valve can further comprise one or more of the steps disclosed herein.

[0057] In some examples, the prosthetic heart valve can comprise a radially expandable frame comprising a radiopaque plating and the method can further comprise aligning the radiopaque plating relative to an anatomical landmark within or adjacent the native heart valve under fluoroscopy.

[0058] In some examples, the frame can comprise a plurality of commissure support portions, wherein at least one of the commissure support portions can include the radiopaque plating, and the act of aligning the portion of the frame can comprise rotationally aligning the radiopaque plating with a commissure of the native heart valve.

[0059] In some examples, the frame can comprise an inlet region with a radiopaque plating, and the act of aligning the portion of the frame can comprise axially aligning the plated, inlet region of the frame within an annulus the native heart valve.

[0060] In some examples, the frame can comprise a plurality of struts and selected struts of the plurality of struts can have the radiopaque plating, and the act of aligning the portion of the frame can comprise rotationally aligning the radiopaque plating with a coronary artery.

[0061] In some examples, the method can further comprise plating a portion of a prosthetic heart valve frame with a radiopaque material, wherein the frame can comprise a first metal having a first radiopacity and the radiopaque material can comprise a second metal having a second radiopacity greater than the first radiopacity.

[0062] In some examples, the method can further comprise masking the prosthetic heart valve frame to form a masked region and an unmasked region of the frame.

[0063] In some examples, the act of masking the frame can comprise applying a masking material to the frame to form the masked region.

[0064] In some examples, the act of masking the frame can comprise selectively removing the masking material to form the unmasked region.

[0065] In some examples, the act of plating a portion of the frame can comprise changing a radiopacity of the unmasked region from the first radiopacity to the second radiopacity.

[0066] In some examples, the act of plating a portion of the frame can comprise coating portions of only an exterior surface of the frame with the second metal.

[0067] In some examples, the method can further comprise arranging a plurality of leaflets within the frame and securing commissures of the leaflets to the frame.THVVA-24038WO01

[0068] In some examples, the act of plating a portion of the frame can comprise electroplating the portion of the frame with the radiopaque material.

[0069] In some examples, a method of implanting a prosthetic heart valve comprises delivering the prosthetic heart valve to an implantation site at a native heart valve in a radially crimped configuration, wherein the prosthetic heart valve comprises a radially expandable frame comprising a radiopaque plating; aligning the radiopaque plating relative to an anatomical landmark within or adjacent the native heart valve under fluoroscopy; and expanding the prosthetic heart valve into a radially expanded configuration at the implantation site.

[0070] In some examples, a method comprises plating a portion of a prosthetic heart valve frame with a radiopaque material, wherein the frame comprises a first metal having a first radiopacity and the radiopaque material comprises a second metal having a second radiopacity greater than the first radiopacity.

[0071] In some examples, a method of implanting and / or plating a prosthetic heart valve comprises one or more of the steps recited in Examples 56-77 below.

[0072] 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

[0073] FIG. 1 is a side view of a prosthetic heart valve comprising a frame, according to an example.

[0074] FIG. 2 is a perspective view of the frame of the prosthetic heart valve of FIG. 1.

[0075] FIG. 3 is a perspective view of a prosthetic heart valve comprising a frame, according to an example.

[0076] FIG. 4 is a perspective view of the prosthetic valve of FIG. 3 with the components on the outside of the frame shown in transparent lines for purpose of illustration.THVVA-24038WO01

[0077] FIG. 5 is a side view of a frame of a prosthetic heart valve, according to an example, where a portion of a commissure window has a radiopaque plating.

[0078] FIG. 5A is an enlarged view of the commissure window with the radiopaque plating of FIG. 5.

[0079] FIG. 6 is a side view of the frame of FIG. 5, according to an example, where the frame is shown in a straightened (non-annular) state and has inlet struts and commissure windows with a radiopaque plating.

[0080] FIG. 7 is a side view of the frame of FIG. 5, according to an example, where the frame is shown in a straightened (non-annular) state and has a plurality of inlet rows of cells and commissure windows with a radiopaque plating.

[0081] FIG. 8 is a side view of a frame of a prosthetic heart valve, according to an example, where the frame is shown in a straightened (non-annular) state and where a portion of each commissure support cell has a radiopaque plating.

[0082] FIG. 8A is an enlarged view of one commissure support cell with the radiopaque plating of FIG. 8.

[0083] FIG. 9 is a side view of the frame of FIG. 8, according to an example, where the frame has an inlet row of cells with a radiopaque plating.

[0084] FIG. 10 is a side view of the frame of FIG. 8, according to an example, where an inlet portion of the frame has a radiopaque plating.

[0085] FIG. 11 is a side view of a delivery apparatus for a prosthetic heart valve, according to an example.

[0086] FIG. 12 is a side view of the frame of FIG. 5, according to an example, where the frame is shown in a straightened (non-annular) state and has an intermediate portion and commissure windows with a radiopaque plating.DETAILED DESCRIPTIONGeneral Considerations

[0087] 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. TheTHVVA-24038WO01methods, 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.

[0088] 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 correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0089] 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.” The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps not expressly referenced. 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. It is further noted that the claims can be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

[0090] 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 (e.g., outTHVVA-24038W001of the subject’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (e.g., into the subject’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0091] Reference throughout this specification to “an implementation” means that a particular feature, structure, or characteristic described in connection with the implementation is included in at least one implementation. Thus, appearances of the phrases “in an implementation” or “in some implementations” in various places throughout this specification are not necessarily all referring to the same implementation or a single exclusive implementation. Furthermore, the particular features, structures, or characteristics described herein may be combined in any suitable manner in one or more implementations.

[0092] The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any aspect described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects. Unless specifically stated otherwise, the term “some” refers to one or more.

[0093] It will be understood that the benefits and advantages described herein can relate to one implementation or can relate to several implementations. Aspects described in connection with one implementation are intended to be able to be used with the other implementation. Any explanation in connection with one implementation applies to similar features of the other implementations, and elements of multiple implementations can be combined to form other implementations. The implementations are not limited to those that solve any or all of the stated problems or those that have any or all of the stated benefits and advantages.

[0094] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain implementations herein is intended merely to better illuminate the devices and methods disclosed herein and does not pose a limitation on the scope of the disclosure otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the disclosure.

[0095] All structural and functional equivalents to the components of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to beTHVVA-24038WO01encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

[0096] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0097] Described herein are examples of prosthetic heart valves (also referred to herein as “prosthetic valves"), prosthetic valve frames with radiopaque plating, and leaflet assemblies for prosthetic heart valves. Also described herein are examples of methods for aligning a prosthetic heart valve within a native heart valve (also referred to herein as a “native valve”) and configurations and methods for plating prosthetic valve frames with radiopaque materials. The prosthetic heart valves can comprise a radially expandable and compressible annular frame with a plurality of struts which can be arranged in a plurality of circumferentially extending rows of struts forming at least one circumferentially extending row of cells. The prosthetic valves can further comprise a valvular structure located within the frame. The valvular structure can comprise a plurality of leaflets and a plurality of prosthetic leaflet commissures that can be secured to commissure support portions in the frame. The prosthetic leaflets regulate a flow of blood through the frame in one direction from the inlet end of the frame to an outlet end of the frame.

[0098] Axially and rotationally aligning features of a prosthetic heart valve with features of a native heart valve and / or a surrounding anatomy during implantation can be advantageous. For example, rotationally aligning prosthetic leaflet commissures of a prosthetic heart valve with the commissures of the native aortic valve can improve blood flow through the prosthetic valve to the coronary arteries. In some examples, rotational alignment of the prosthetic heart valve can further improve coronary access to arteries in subsequent procedures. Additionally or alternatively, axially aligning an inlet portion of an annular frame of a prosthetic heart valve with a native aortic valve annulus can reduce the likelihood of conduction disturbances and / or paravalvular leakage after prosthetic valve implantation.

[0099] As introduced above, in known prosthetic heart valves, separate radiopaque markers can be attached to surfaces of a prosthetic heart valve or a prosthetic heart valve delivery apparatus. In some examples, the addition of radiopaque markers to a prosthetic heart valve can increase the time and complexity of the manufacturing process. Moreover, separate radiopaque markers can increase the overall crimp profile of a prosthetic heart valve, whichTHVVA-24038WO01can increase the push forces required to advance the prosthetic valve through an introducer sheath.

[0100] Described herein are prosthetic valve frames (also referred to herein as “frames” or “valve frames”) comprising regions of selective radiopaque plating that can be visualized under fluoroscopy for alignment during implantation or for post-implantation procedures. By selectively plating a radiopaque material onto specific regions of a prosthetic valve frame, radiopaque features visible under fluoroscopy can be integrated directly into the structure of the frame without the need for additional components. Thus, in some examples, the radiopaque plating can simplify the manufacturing process.

[0101] FIG. 1 illustrates an exemplary prosthetic heart valve comprising a frame, leaflets secured on an inside of the frame, and an outer skirt disposed around an outer surface of the frame. FIG. 2 shows the frame of the prosthetic heart valve of FIG. 1 with commissure support portions in the form of commissure windows which are configured to receive leaflet commissures.

[0102] FIG. 3 shows an example of another exemplary prosthetic heart valve that comprises a frame, a plurality of leaflets, and an outer sealing member. As seen in FIG. 4, the frame of the prosthetic heart valve of FIG. 3 can have commissure support portions in the form of commissure support cells which are configured to receive leaflet commissures.

[0103] FIGS. 5 and 5A show a frame for a prosthetic heart valve, according to an example, where the frame has portions of a commissure window with a radiopaque plating. FIGS. 6-7 show the frame of FIGS. 5 and 5 A in a flattened, non-annular state where the frame comprises inlet portions with a radiopaque plating, according to an example.

[0104] FIGS. 8 and 8 A show a frame for a prosthetic heart valve in a flattened, non-annular state, according to an example, where the frame comprises portions of commissure support cells with a radiopaque plating. FIGS. 9-10 show the frame of FIGS. 8 and 8 A where the frame comprises inlet portions with a radiopaque plating, according to an example.

[0105] Prosthetic heart valves (such as the prosthetic valves of FIGS. 1-4, or any other prosthetic valve described herein) comprising frames (such as the frames shown in FIGS. 5-10, or any other frame described herein) can be advanced through a subject’s vasculature, such as to a native heart valve for implantation, by a delivery apparatus, such as the exemplary delivery apparatus shown in FIG. 11.THVVA-24038W001

[0106] FIG. 12 is a side view of a frame for a prosthetic heart valve in a straightened (nonannular state) and having an intermediate portion and commissure windows (e.g., portions thereof) with a radiopaque plating.Examples of the Disclosed Technology

[0107] Prosthetic heart valves (also referred to herein as “prosthetic valves’’) disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a subject’s vasculature on a delivery apparatus. The prosthetic valve can be expanded to the radially expanded state (e.g., a deployed state) once the prosthetic valve reaches an 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 below.

[0108] FIG. 1 shows an exemplary prosthetic heart valve 100, according to an example. Any of the prosthetic valves disclosed herein can be adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves can also 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 subject (e.g., a living subject, a simulation, etc.). The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0109] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U. S. Publication No. 2017 / 0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. W02020 / 247907, which is incorporated by reference herein. In another example, theTHVVA-24038WO01disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U. S. Publication No. 2019 / 0000615, which is incorporated by reference herein.

[0110] The prosthetic heart valve 100 of FIG. 1 can be radially expandable and compressible between a radially expanded working state and a radially compressed state. In some examples, the prosthetic heart valve 100 can be expandable to any one of a plurality of radially expanded working states that includes a smallest radially expanded working state and a largest radially expanded working state. In this way, the prosthetic heart valve can beneficially be adapted and / or configured to be implanted into different sizes of native annuluses and / or other anatomic features (for example, vessels communicating with the heart such as the pulmonary artery, the superior vena cava, the inferior vena cava, or other various veins, arteries, and vessels).

[0111] As shown in FIG. 1, the prosthetic heart valve 100 can include a stent or frame 102, a valvular structure 104 disposed on an inside of the frame 102, and a perivalvular outer sealing member or outer skirt 106, and an inner skirt 107, in some examples. The prosthetic heart valve 100 (and the frame 102) can have an inflow end 108 and an outflow end 110. The valvular structure 104 can be disposed on an interior of the frame 102 while the outer skirt 106 can be disposed around an outer surface 109 of the frame 102.

[0112] The valvular structure 104 can comprise a plurality of leaflets 112 (for example, three leaflets), collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement. The leaflets 112 can be secured to one another at their adjacent sides (for example, at commissure tabs 115) to form commissures 114 of the valvular structure 104. For example, each leaflet 112 can comprise opposing commissure tabs 115 disposed on opposite sides of the leaflet 112 and a cusp edge portion extending between the opposing commissure tabs 115. In some examples, the cusp edge portion of the leaflets 112 can have an undulating, curved scalloped shape. In some examples, the cusp edge portions of the leaflets can be secured to the inner skirt 107 and / or to the frame 102 (for example, by sutures).

[0113] In some examples, the leaflets 112 (and / or any leaflets described herein) can be formed of pericardial tissue (for example, bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art andTHVVA-24038WO01described in U. S. Patent No. 6,730,118, which is incorporated by reference herein in its entirety.

[0114] In some examples, the outer skirt 106 can be an annular skirt. In some examples, the outer skirt 106 can comprise one or more skirt portions that are connected together and / or individually connected to the frame 102.

[0115] The inner skirt 107 can be disposed between an inner surface 113 (FIG. 2) of the annular frame 102 and outer surfaces 116 (i.e., outflow surfaces) of the leaflets 112. In some examples, the inner skirt 107 can comprise one or more skirt portions that are connected together.

[0116] The outer skirt 106 and / or an inner skirt 107 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the outer skirt 106 and / or the inner skirt 107 can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the outer skirt 106 and / or the inner skirt 107 can comprise a fabric without interlaced yams or fibers or randomly interlaced yams or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the outer skirt 106 and / or the inner skirt 107 can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the outer skirt 106 and / or the inner skirt 107 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the outer skirt 106 and / or the inner skirt 107 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0117] FIG. 2 is a perspective view of the frame 102 of FIG. 1, where the frame 102 is in an exemplary radially expanded (annular) state. The frame 102 and / or any one of the frames disclosed herein can be made of any of various suitable plastically-expandable materials (forTHVVA-24038W001example, stainless steel, etc.) or self-expanding materials (for example, Nitinol). When constructed of a plastically-expandable material, the frame 102 (and thus the prosthetic heart valve 100) can be crimped to a radially compressed (or crimped) state on a delivery apparatus (such as the delivery apparatus shown in FIG. 11), and then expanded inside a subject by an inflatable balloon or equivalent expansion mechanism. When constructed of a selfexpandable material, the frame 102 (and thus the prosthetic heart valve 100) can be crimped to a radially compressed state and restrained in the radially 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 state (for example, any one of the plurality of radially expanded working states).

[0118] Suitable plastically-expandable materials that can be used to form the frame 102 include metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame can comprise stainless steel. In some examples, the frame can comprise cobalt-chromium. In some examples, the frame can comprise nickel-cobalt-chromium. In some examples, the frame comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0119] As seen in FIG. 2, the frame 102 can comprise a plurality of interconnected stmts 117 that form open cells 118 arranged in multiple rows of cells that extend in a circumferential direction and are disposed between the inflow end 108 and the outflow end 110 of the frame 102.

[0120] In the example shown in FIG. 2, the frame 102 can comprise four circumferentially extending rows of cells with a first (upper in the orientation shown in FIGS. 1-2) row disposed at the outflow end 110. In some examples, the first row can comprise cells 118a that are elongated in an axial direction (relative to a central longitudinal axis 122 of the frame 102), compared to cells 118b in the remaining rows. In some examples, the cells 118a of the first row may not be elongated relative to the other rows and / or the cells of the other rows may be elongated relative to the remaining rows. In some examples, the cells 118 can beTHVVA-24038W001diamond-shaped. As shown, the frame 102 includes twelve cells per row. In some examples, the frame 102 can include a greater or fewer number of cells in each row.

[0121] The frame can further comprise a plurality of axially extending commissure support portions 130 and a plurality of axial stmts 132. The axially extending commissure support portions 130 can have an inflow end portion 134 and an outflow end portion 136 and can define commissure windows 140 that are spaced apart from one another around the frame 102 in a circumferential direction.

[0122] The frame 102 can further comprise a plurality of apices (the highest or most outward extending, in an axial direction, point) 150 formed at the inflow end 108 and the outflow end 110. The apices 150 can be spaced apart from one another, in a circumferential direction at the inflow end 108 and the outflow end 110.

[0123] Referring back to FIG. 1, the commissure tabs 115 of adjacent leaflets 112 can be secured together to form commissures 114 as described above. In some examples, each of the commissures 114 of the prosthetic heart valve 100 can comprise two commissure tabs 115 paired together, one from each of two adjacent leaflets 112, with each pair of tabs 115 extending through the commissure window 140 of the frame 102. Each commissure 114 can be secured to a respective commissure window 140.

[0124] FIGS. 3 and 4 show another exemplary prosthetic valve 200, according to an example. The prosthetic valve 200 can have a stent or frame 202, a valvular structure 204, and a seahng member 206. FIG. 4 is a perspective view of the prosthetic valve 200 with the components on the outside of the frame 202 (such as the sealing member 206) shown in transparent lines for purposes of illustration. The prosthetic valve 200 can have an inflow end 208 and an outflow end 210.

[0125] The valvular structure 204 can comprise three leaflets 212, collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although in other examples there can be greater or fewer number of leaflets (e.g., one or more leaflets 212). In some examples, as described above regarding the leaflets 112, the leaflets 212 can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U. S. Patent No. 6,730,118.

[0126] Each leaflet 212 can be coupled to the frame 202 along its inflow edge 213 (the lower edge in the figures; also referred to as “cusp edges”) and at commissures 214 of the valvularTHVVA-24038W001structure 204 where adjacent portions (e.g., commissure tabs) of two leaflets are connected to each other. In some examples, the commissures 214 can comprise an attachment member (e.g., comprising fabric, flexible polymer, or the like) arranged across a cell (e.g., a commissure support cell 218a) of the frame 202, the cell formed by stmts of the frame. The attachment member can be secured to the stmts of the frame forming the cell and the adjacent portions of the two leaflets (e.g., two adjacent commissure tabs) can be connected to the attachment member to form the commissure 214.

[0127] In some examples, a reinforcing element or connecting skirt, such as a fabric strip, can be connected directly to the cusp edges of the leaflets and to the stmts of the frame to couple the cusp edges of the leaflets to the frame.

[0128] As described above regarding frame 102, the frame 202 can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol). When constmcted of a plastically-expandable material, the frame 202 (and thus the prosthetic valve 200) can be crimped to a radially collapsed configuration on a delivery apparatus (e.g., catheter) and then expanded inside a subject by an inflatable balloon or equivalent expansion mechanism. Various crimping devices can be used to crimp the prosthetic valve 200 and the other prosthetic valves described herein around the delivery apparatus, such as the crimping devices described in U. S. Patent No. 7,530,253, which is incorporated herein by reference.

[0129] In some instances, the prosthetic valve 200 can be crimped directly onto the inflatable balloon of the delivery apparatus, such that the prosthetic valve 200 is axially aligned with and disposed radially outward of the balloon during advancing the prosthetic valve on the delivery apparatus to the implantation site, for example as described in PCT Application No. PCT / US2021 / 047056, which is incorporated herein by reference. In alternate instances, the prosthetic valve 200 can be crimped onto the delivery apparatus axially offset from the balloon, and then moved over the balloon at the implantation site, prior to inflation of the balloon and radial expansion of the prosthetic valve, such as described in U. S. Patent Application 9,339,384, which is incorporated herein by reference in its entirety.

[0130] When constmcted of a self-expandable material, the frame 202 (and thus the prosthetic valve 200) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a deliveryTHVVA-24038WO01apparatus. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

[0131] Suitable plastically-expandable materials that can be used to form the frame 202 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 202 can comprise stainless steel. In some examples, the frame 202 can comprise cobalt-chromium. In some examples, the frame 202 can comprise nickel-cobalt-chromium. In some examples, the frame 202 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0132] The frame 202 in the illustrated example comprises a plurality of circumferentially extending rows of angled struts 217 defining rows of open cells 218 (or openings) of the frame. The frame 202 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 208 to the outflow end 210 of the frame 202 as shown, or the frame 202 can vary in diameter along the height of the frame, as disclosed in U. S. Patent Publication No. 2012 / 0239142, which is incorporated herein by reference.

[0133] The frame 202, at each of the inflow end 208 and the outflow end 210, may comprise a plurality of apices 250 spaced apart from one another around a circumference of the frame 202.

[0134] The sealing member 206 in the illustrated example is mounted on the outside of the frame 202 and functions to create a seal against the surrounding tissue (e.g., the native leaflets and / or native annulus) to prevent or at least minimize paravalvular leakage. The sealing member 206 can comprise an inner layer 260 (which can be in contact with the outer surface of the frame 202) and an outer layer 262. The sealing member 206 can be connected to the frame 202 using suitable techniques or mechanisms. For example, the sealing member 206 can be sutured to the frame 202 via sutures that can extend around the stmts 217 and through the inner layer 260. In some examples, the inner layer 260 can be mounted on the inner surface of the frame 202, while the outer layer 262 is on the outside of the frame 202.

[0135] The outer layer 262 can be configured or shaped to extend radially outward from the inner layer 260 and the frame 202 when the prosthetic valve 200 is deployed. When the prosthetic valve is fully expanded outside of a subject’s body, the outer layer 262 can expandTHVVA-24038W001away from the inner layer 260 to create a space between the two layers. Thus, when implanted inside the body, this allows the outer layer 262 to expand into contact with the surrounding tissue.

[0136] Additional details regarding the prosthetic valve 200 and its various components are described in U. S. Patent Publication No. 2018 / 0028310 and U. S. Patent No. 12,004,947, which are incorporated herein by reference.

[0137] As introduced above, prosthetic valve frames disclosed herein can comprise radiopaque markers for alignment with an anatomical landmark within or adjacent a native heart valve during delivery and implantation. FIGS. 5 and 5 A show an example of a frame 300 for a prosthetic valve, where selected regions of the frame 300 comprise radiopaque plating. The frame 300 comprises an inflow end (also referred to herein as an “inlet end”) 308, an outflow end (also referred to herein as an “outlet end”) 310, an outer (i.e., exterior) surface 309, and an inner (i.e., interior) surface 313.

[0138] The frame 300 can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol) having a first radiopacity when viewed under fluoroscopy. Suitable plastically-expandable materials that can be used to form the frame 300 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 300 can comprise stainless steel. In some examples, the frame 300 can comprise cobalt-chromium. In some examples, the frame 300 can comprise nickel-cobalt-chromium. In some examples, the frame 300 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight. The material of the frame 300 can be selected to optimize contrast with plated regions of the frame as will be described further below.

[0139] The frame 300 comprises a plurality of interconnected struts 317 that form open cells 318 arranged in multiple rows of cells that extend in a circumferential direction and are disposed between the inflow end 308 and the outflow end 310 of the frame 300.

[0140] In the example shown in FIGS. 5 and 5A, the frame 300 can comprise four circumferentially extending rows 319, 321, 323, and 325 of cells with a first row 319 (theTHVVA-24038W001upper row in the orientation shown in FIG. 5) disposed at the outflow end 310. In some examples, the first row 319 can comprise cells 318a that are elongated in an axial direction (relative to a central longitudinal axis 322 of the frame 300), compared to cells 318b in rows 321 and 323 and cells 318c in row 325. In some examples, the cells 318a of the first row 319 may not be elongated relative to the other rows 321, 323, 325 and / or the cells of the other rows 321, 323, 325 may be elongated relative to the remaining rows. In some examples, the cells 318 can be diamond-shaped. As shown, the frame 300 includes twelve cells per row. In some examples, the frame 300 can include a greater or fewer number of cells in each row.

[0141] The frame can further comprise a plurality of axially extending commissure support portions (also referred to herein as “commissure support portions") 330 and a plurality of axial struts 332 disposed in the first row 319 of cells at the outflow end 310. Each of the axially extending commissure support portions 330 can have an inflow end portion 334 and an outflow end portion 336. In the example shown in FIGS. 5 and 5A, the axially extending commissure support portions 330 are shown as commissure windows 340 that are spaced apart from one another around the frame 300 in a circumferential direction.

[0142] Each commissure window 340 can have a first axially extending commissure support strut 342 and a second axially extending commissure support strut 344 that is parallel to the first axially extending commissure support strut 342 and circumferentially offset therefrom to define a slot or opening 345 for receiving a commissure. A first circumferential strut 346 extends laterally between and connects inflow end portions of the first and second axially extending commissure support struts 342, 344, and a second circumferential strut 348 extends laterally between and connects outflow end portions of the first and second axially extending commissure support struts 342, 344. In this way, the slot 345 is bounded circumferentially by the first and second axially extending commissure support struts 342, 344 and axially by the first and second circumferential struts 346, 348. Commissures of a valvular structure (for example, valvular structure 104) can extend through the slots and can be secured to the commissure windows 340 as shown and described above in connection with FIG. 1. As such, the circumferential locations of the commissure windows 340 correspond to locations of respective prosthetic leaflet commissures.

[0143] In some examples, a prosthetic heart valve can include the frame 300, a valvular structure (for example, valvular structure 104), an inner skirt (for example, inner skirt 107), and an outer skirt (for example, outer skirt 106). Further details regarding the frame 300 andTHVVA-24038WO01prosthetic heart valves that include the frame 300 are disclosed in U. S. Patent No. 9,393,110, which is incorporated herein by reference.

[0144] As described above, it can be advantageous to identify the location of at least one prosthetic leaflet commissure under fluoroscopy for alignment with a native valve commissure during implantation. In some examples, the outer surface 309 of the frame 300 can be configured with radiopaque plating along portions of at least one commissure window 340. For example, the outer surface 309 along the first axially extending commissure support strut 342, the first circumferential strut 346, and the second circumferential strut 348 of a commissure window 340 can be plated, thus forming a radiopaque indicator 370a at the commissure window 340 in a backwards C shape, as shown in stippling in FIGS. 5 and 5A.

[0145] Materials having a second radiopacity that is greater than the first radiopacity of the frame 300 can be selected for use in plating. In other words, it is advantageous that the radiopaque plating be different and darker under fluoroscopy than the non-plated regions of the frame. For example, the radiopaque plating material can comprise any bio-compatible metal such as, for example, gold, platinum, iridium, palladium, tantalum, and rhodium. As introduced above, the radiopaque plating material can be selected to maximize contrast between the plated regions of the frame 300 and the non-plated regions of the frame for enhanced visibility. In this way, when a user (e.g., a surgeon) is orienting a prosthetic heart valve comprising the frame 300 for implantation in a native valve, the relative axial and rotational position of the plated portions of the frame 300 (the commissure windows 340, for example) are clearly visible and contrast with the non-plated portions of the frame 300.Accordingly, the user can adjust the relative position of the prosthetic heart valve for alignment. In the example shown in FIG. 5, the user can rotationally align the one or more commissure windows 340 comprising the radiopaque plating (and, by extension, the prosthetic leaflet commissures attached thereto) with the commissures of the native valve.

[0146] The radiopaque indicator 370a shown in FIGS. 5 and 5A can have an asymmetric shape that is reflection asymmetric along an axis that is parallel to the central longitudinal axis 322 of the frame. Thus, the radiopaque indicator 370a has a first orientation when the indicator is in the foreground of a fluoroscopic view and a second, reversed orientation when the indicator is in the background of a fluoroscopic view. The different orientations allow the user to determine whether the radiopaque indicator 370a (and the commissure window, for example) is in the foreground (the front of the frame) or in the background (the back of theTHVVA-24038WO01frame) in the fluoroscopic view. The user can thus orient the radiopaque indicator 370a and the prosthetic valve rotationally in space with respect to anatomical landmarks within or adjacent the native heart valve.

[0147] In some examples, one or more of the commissure windows 340 includes a respective radiopaque indicator 370a, such as one of the commissure windows 340, two of the commissure windows 340, or all of the commissure windows 340.

[0148] In some examples, the radiopaque indicator 370a can comprise plating along the second axially extending commissure support strut 344 (without plating on the first axially extending support strut 342) and both of the first and second circumferential struts 346, 348, thus forming a forward facing C shape.

[0149] In some examples, the radiopaque indicator 370a can comprise plating along the second axially extending commissure support strut 344 and either the first circumferential stmt 346, forming an L shape, or the second circumferential strut 348, forming an uppercase gamma shape.

[0150] In some examples, the radiopaque indicator 370a can comprise plating along the first axially extending commissure support strut 342 and either the first circumferential stmt 346, forming a backwards L shape, or the second circumferential strut 348, forming a backwards, uppercase gamma.

[0151] In some examples, the radiopaque indicator 370a can comprise plating along selected portions of the first axially extending commissure support strut 342, the second axially extending commissure support strut 344, the first circumferential stmt 346, and / or the second circumferential strut 348. In some examples, the radiopaque indicator 370a can be reflection symmetric along an axis that is parallel to the central longitudinal axis 322 of the frame 300. For example, plating can be provided on the outer surfaces of each strut 342, 344, 346, and 348 to form a rectangular radiopaque indicator. In some examples, the frame 102 (FIGS. 1-2) can be provided with radiopaque plating at one or more of the commissure windows 140 to form one or more radiopaque indicators 370a.

[0152] In some examples, the plating forming the radiopaque indicator 370a is formed only on the outer surface of the frame. In lieu of or in addition to forming the plating on the outer surface of the frame, the plating can be formed on the inner surface of the frame, and / or on the side surfaces of the struts 342, 344, 346, and / or 348.THVVA-24038W001

[0153] Additionally or alternatively, as described above, it can be advantageous to axially align an inlet portion of a prosthetic heart valve with a native annulus of a native heart valve. FIGS. 6-7 show examples of the frame 300 with inlet portions of the frame 300 having radiopaque plating. FIGS. 6-7 show the frame 300 of FIG. 5 in a straightened and flattened (non-annular) state. Although FIGS. 6-7 show the frame 300 in a flattened configuration with a first side 377 and a second side 379 shown on opposing ends, it is understood that the first side 377 actually extends directly into the second side 379. In other words, the annular frame 300 is shown cut and flattened for clarity in viewing the multiple rows of cells 318 and the angled struts 317 that form the frame 300.

[0154] In some examples, the frame 300 can include a first row 380 of angled struts 317a defining the inflow end of the frame, a second row 382 of angled struts 317b, a third row 384 of angled struts 317c, a fourth row 386 of angled struts 317d, and a fifth row 388 of angled struts 317e defining the outflow end of the frame. A row of vertical struts 390 can extend between and connect the first and second rows 380, 382 of angled stmts.

[0155] In some examples, at least a portion of the outer surface 309 of the frame 300 along a first row 380 of angled struts 317a at the inflow end 308 of the frame 300 can have radiopaque plating, forming a radiopaque indicator 370b shown by the stippling in FIG. 6. In some examples, the entirety of the outer surface 309 of the frame along the first row 380 of stmts 317a is covered with the radiopaque plating, as shown in FIG. 6. In some examples, all of the surfaces (i.e., interior, exterior, and side surfaces) of the angled struts 317a can have radiopaque plating. The indicator 370b can be used to denote the inflow end 308 of the frame 300 during implantation and axial alignment. For example, during an implantation procedure, the indicator 370b can be more precisely aligned with the native aortic valve annulus, while avoiding contact between the frame and the left branch bundle just below the aortic valve annulus. Avoiding contact with the left branch bundle can reduce conduction disturbances and the need for a pacemaker post deployment.

[0156] In some examples, the outer surface 309 of the frame 300 along each of the angled struts 317 disposed within a distance dl from the inflow end 308 can have radiopaque plating, thus forming a radiopaque indicator 370c shown in stippling in FIG. 7. In some examples, all of the surfaces (i.e., interior, exterior, and side surfaces) of the frame 300 along each of the angled struts 317 within the distance dl can have radiopaque plating.THVVA-24038W001

[0157] In some examples, the distance dl can be selected to span the first row 380 of angled struts 317a and the row of vertical struts 390. In some examples, the distance dl can span the first row 380 of angled struts 317a, the row of vertical struts 390, and the second row 382 of angled struts 317b (i.e., row 325 of cells). In some examples, as shown in FIG. 7, the distance dl can span the first row 380 of angled struts 317a, the row of vertical struts 390, the second row 382 of angled struts 317b, and the third row 384 of angled struts 317c (i.e., rows 325, 323 of cells). In some examples, as shown in FIG. 7, the distance dl can span the first row 380 of angled struts 317a, the row of vertical struts 390, the second row 382 of angled struts 317b, the third row 384 of angled struts 317c, the fourth row 386 of angled struts 317d, and optionally at least along the axially extending commissure support portions 330 and the axial stmts 332.

[0158] In some examples, the distance dl can be selected to extend at least 40% of the total axial height hl of the frame 300 from the inflow end 308, where the total axial height hl extends from the inflow end 308 to the outflow end 310 of the frame 300. In some examples, the distance dl can be selected to extend at least 10%, 20%, 30%, 40% 50%, 60%, 70%, 80%, or 90% of the total height hl of the frame 300 from the inflow end 308.

[0159] In some examples, the axial height of the indicator 370c (equal to dl) can be selected to match an axial height of an outer skirt or sealing member (for example, outer skirt 106 or sealing member 206), which allows the user to more accurately align the outer skirt or sealing member of the prosthetic valve with a native annulus, thus reducing paravalvular leakage. For example, if the indicator 370c is formed on the struts of the first row 380, the second row 382, the third row 384, and the row of struts 390, the outer skirt can extend from the first row 380 of angled struts 317a to the third row 384 of angled struts 317c.

[0160] In some examples, an intermediate portion of the frame 300 can have radiopaque plating that forms a radiopaque indicator 370d in the shape of a discontinuous band of spaced apart radiopaque markers along a row of stmts, such as shown in stippling in FIG. 12. The indicator 370d is formed by plated portions of the stmts 317c of the third row 384 of stmts. In the illustrated example, the stmts 317c are not plated along their entire length such that plated portions of pairs of stmts 317c form respective radiopaque markers having an inverted V-shape that are spaced apart from each other in a circumferential direction. In other examples, the indicator 370d can be a continuous band of radiopaque plating extending along the entire row 384.THVVA-24038W001

[0161] An outflow end of the radiopaque marker 370d can be disposed a distance d3 from the inflow end 308 of the frame 300 and have an axial height 392. In some examples, the outer surface 309 of the frame 300 in the region of the radiopaque marker 370d can be plated. In some examples, all of the surfaces (i.e., interior, exterior, and side surfaces) of the frame 300 in the region of the radiopaque marker 370d can be plated. The distance d3 can extend, for example, 11 mm from the inflow end 308 of the frame 300. The axial height 392 can extend, for example, 1.5 mm. In other examples, in lieu of or in addition to the indicator 370d, the frame 300 can have the same discontinuous band of radiopaque markers formed on one or more of the other rows of stmts (any one of rows 380, 382, 384, 386, and / or 388). In some examples, the frame 400 can have one or more indicators comprising a discontinuous band of markers (e.g., indicator 370d) on one or more rows of struts of the frame 400.

[0162] As described above for FIGS. 5 and 5A, materials having a second radiopacity that is greater than the first radiopacity of the frame 300 can be selected for use forming the indicators 370b, 370c, and 370d shown in FIGS. 6-7 and 12 and described above. The radiopaque plating material can be selected to maximize contrast between the plated regions (e.g., the plated inlet region and / or the plated intermediate portion) of the frame 300 and the remaining non-plated regions of the frame for enhanced visibility. In this way, when a user (e.g., a surgeon or physician) is orienting a prosthetic heart valve comprising the frame 300 for implantation in a native valve, the relative axial position of the plated portions of the frame 300 are clearly visible in contrast to the non-plated portions of the frame 300. The outer skirt of a prosthetic heart valve typically defines the “landing zone” of the prosthetic valve; that is, the region of the prosthetic valve that ideally contacts the surrounding native annulus when the prosthetic valve is expanded to optimize sealing of the outer skirt against the surrounding annulus. If, as described above, the plated portions of the frame correspond to the height of the outer skirt, the physician can more accurately and precisely position the landing zone of the prosthetic valve within the native annulus to optimize sealing and minimize paravalvular leakage.

[0163] In some examples, the height dl of the plated portion of the frame can be used to indicate an intended implantation depth of the prosthetic heart valve, which can be described as the ratio of the portion of the prosthetic valve positioned supra-annularly to the portion of the portion of the prosthetic valve positioned sub-annularly when the prosthetic valve is fully deployed. For example, for an 80 / 20 deployment, 80% of the prosthetic valve is positionedTHVVA-24038WO01supra-annularly and 20% of the prosthetic valve is positioned sub-annularly; for an 90 / 10 deployment, 90% of the prosthetic valve is positioned supra-annularly and 10% of the prosthetic valve is positioned sub-annularly, and so on. The height dl therefore can be selected to correspond to the portion of the frame that is to be positioned sub-annularly for a desired deployment position. For example, the height dl can be 10% of the total height hl for a 90 / 10 deployment position, 20% of the total height hl for a, 80 / 20 deployment position, 30% of the total height hl for a 70 / 30 deployment position, 40% of the total height hl for a 60 / 40 deployment position, 50% of the total height hl for a 50 / 50 deployment position, and so on.

[0164] In some examples, the radiopaque indicator 370d may be similarly used to mark an intended implantation depth of the prosthetic heart valve as described above in connection with the radiopaque indicator 370c. Accordingly, the distance d3 from the inflow end 308 of the frame 300 can be selected to indicate the portion of the frame that is to be positioned sub-annularly for a desired deployment position as described above.

[0165] In some examples, the frame 300 can comprise one or more radiopaque indicators 370a, the indicator 370b, or both one or more radiopaque indicators 370a and the radiopaque indicator 370b.

[0166] In some examples, the frame 300 can comprise one or more radiopaque indicators 370a, the radiopaque indicator 370c, or both one or more radiopaque indicators 370a and the radiopaque indicator 370c.

[0167] In some examples, the frame 300 can comprise one or more radiopaque indicators 370a, the radiopaque indicator 370d, or both one or more radiopaque indicators 370a and the radiopaque indicator 370d.

[0168] In some examples, the frame can comprise only the radiopaque indicator 370b, the radiopaque indicator 370c, or the radiopaque indicator 370d.

[0169] In some examples, radiopaque indicators may comprise different radiopaque plating materials having different radiopacities to distinguish between different radiopaque indicators on the frame. For example, as shown in FIG. 12, the radiopaque markers 370a may have a greater radiopacity and be darker under fluoroscopy than the radiopaque marker 370d. In other words, the radiopaque plating material of individual markers (e.g., indicators 370a, 370b, 370c, and / or 370d) on the frame 300 can be varied to further differentiate portions of the frame for improved visualization for relative positioning in space.THVVA-24038WO01

[0170] In some examples, it may be advantageous to identify the location of an outlet portion of a prosthetic heart valve under fluoroscopy during or after implantation. In some examples, all of the angled struts 317e at the outflow end 310 of the frame 300 can have radiopaque plating, in lieu of or in addition to other portions of the frame having radiopaque plating as described above. In some examples, selected angled struts 317e at the outflow end 310 of the frame 300 can have radiopaque plating. In some examples, the apices at the outflow end 310 of the frame 300 can have radiopaque plating, or selected apices at the outflow end 310 of the frame 300 can have radiopaque plating, in lieu of or in addition to other portions of the frame having radiopaque plating as described above. For example, only the apices adjacent to the commissure support portions 330 can have radiopaque plating.

[0171] Radiopaque plating can be applied to other examples of prosthetic valve frames, for example, a frame 400 shown in FIG. 8. FIG. 8 shows an example of the frame 400 for a prosthetic heart valve in a straightened and flattened (non-annular) state. The frame 400 comprises an inflow end (also referred to herein as an “inlet end”) 408, an outflow end (also referred to herein as an “outlet end”) 410, an outer (i.e., exterior) surface 409, and an inner (i.e., interior) surface 413.

[0172] As described above for other frames, the frame 400 can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol) having a first radiopacity when viewed under fluoroscopy. Suitable plastically-expandable materials that can be used to form the frame 400 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 400 can comprise stainless steel. In some examples, the frame 400 can comprise cobalt-chromium. In some examples, the frame 400 can comprise nickel-cobalt-chromium. In some examples, the frame 400 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight. As described above for frame 300, the material of the frame 400 can be selected to optimize contrast with plated regions of the frame.

[0173] The frame 400 comprises a plurality of horizontal struts 415 and interconnected, angled struts 417. The angled struts 417 are connected to adjacent angled struts 417 by theTHVVA-24038W001horizontal struts 415, thus forming open cells 418 arranged in multiple rows of cells that extend in a circumferential direction and are disposed between the inflow end 408 and the outflow end 410 of the frame 400.

[0174] In the example shown in FIG. 8, the frame 400 can comprise four circumferentially extending rows 419, 421, 423, 425 of cells with a first row 419 (upper in the orientation shown in FIG. 8) disposed at the outflow end 410 and a fourth row 425 (lower in the orientation shown in FIG. 8) disposed at the inflow end 408. In some examples, the first row 419 and the fourth row 425 can comprise cells 418a that are asymmetric, compared to symmetric cells 418b in the intervening rows 421 and 423. In some examples, the cells 418 can be diamond-shaped. As shown in FIG. 8, the frame 400 includes twelve cells per row. In some examples, the frame 400 can include a greater or fewer number of cells in each row.

[0175] The frame can further comprise a plurality of commissure support portions 430 disposed in the first row 419 of cells at the outflow end 410. The commissure support portions 430 are shown as commissure support cells 440 (similar to commissure support cells 218a) that are spaced apart from one another around the frame 400 in a circumferential direction.

[0176] Although FIG. 8 shows the frame 400 in a flattened configuration with a first side 480 and a second side 482 shown on opposing ends, it is understood that the first side 480 actually extends directly into the second side 482. In other words, the annular frame 400 is shown cut and flattened for clarity in viewing the multiple rows of cells 418, and the horizontal and angled struts 415, 417 that form the frame 400.

[0177] As seen in FIGS. 8 and 8 A, the outer surface 409 of the frame 400 can have radiopaque plating along at least a portion of the commissure support cells 440. Each commissure support cell 440 of the frame 400 forms an inner space or opening 445 in the frame bounded by a first angled outflow strut 490, a second angled outflow strut 492, a first angled inflow strut 494, and a second angled inflow strut 496. The first and second angled outflow struts 490, 492 are connected at their outflow ends by a horizontal strut 415a forming an apex 498. The first and second angled inflow struts 494, 496 are connected at their inflow ends by a horizontal strut 415b. The commissures of a valvular structure (for example, valvular structure 204) can be coupled to and supported by the commissure support cells 440, in the same manner as shown in FIG. 3.THVVA-24038W001

[0178] Similar to the radiopaque indicator 370a shown in FIGS. 5 and 5A and described above, portions of at least one commissure support cell 440 can be plated with a radiopaque material. For example, the outer surface 409 along the first and second angled outflow struts 490, 492, and the first angled inflow stmt 494 of a commissure support cell 440 can be plated, thus forming a radiopaque indicator 470a at the commissure support cell 440, as shown in stippling in FIG. 8A.

[0179] As described above, materials having a second radiopacity that is greater than the first radiopacity of the frame 400 can be selected for use in plating. For example, the radiopaque plating material can comprise any bio-compatible plated metal such as, for example, gold, platinum, iridium, palladium, tantalum, and rhodium. The radiopaque plating material can be selected to maximize contrast between the plated regions of the frame 400 and the non-plated regions of the frame for enhanced visibility.

[0180] The radiopaque indicator 470a shown in FIGS. 8 and 8A can have a reflection asymmetric shape along a longitudinal axis as described above for the radiopaque indicator 370a. In this way, the user can orient the radiopaque indicator 470a and the prosthetic valve rotationally in space.

[0181] In some examples, the outer surface 409 of the frame 400 at each commissure support cell 440 around the circumference of the frame 400 can have the radiopaque plating as described and shown in FIG. 8A.

[0182] In some examples, the outer surface 409 of the frame 400 at one or more selected commissure support cells 440 around the circumference of the frame 400 can have the radiopaque plating as described and shown in FIG. 8A.

[0183] In some examples, the radiopaque indicator 470a can comprise plating along the first and second angled outflow struts 490, 492, and the second angled inflow strut 496.

[0184] In some examples, the radiopaque indicator 470a can comprise plating along the first angled outflow strut 490 and the first angled inflow strut 494.

[0185] In some examples, the radiopaque indicator 470a can comprise plating along the second angled outflow strut 492 and the second angled inflow stmt 496.

[0186] In some examples, the radiopaque indicator 370a can comprise plating along the first and second angled inflow stmts 494, 496, and the second angled outflow stmt 492.

[0187] In some examples, the radiopaque indicator 370a can comprise plating along the first and second angled inflow stmts 494. 496, and the first angled outflow stmt 490.THVVA-24038W001

[0188] In some examples, the radiopaque indicator 370a can comprise plating along selected portions of one or more of the first and second angled outflow struts 490, 492, and the first and second angled inflow struts 494, 496, and can be reflection asymmetric or reflection symmetric along a longitudinal axis. In any of the examples of the radiopaque indicator 370a disclosed herein, the plating can be formed on any one or more of the outer surfaces of the struts, the inner surfaces of the struts, and / or the side surfaces of the struts.

[0189] Additionally or alternatively, other portions of frame 400 can be plated for visualization under fluoroscopy. In some examples, the outer surface 409 of the frame 400 along the horizontal and angled stmts 415, 417 forming the fourth row 425 of cells can have radiopaque plating, forming a radiopaque indicator 470b as shown in stippling in FIG. 9. In some examples, the plating that forms the indicator 470b can be formed on any one or more of the outer surfaces of the stmts, the inner surfaces of the stmts, and / or the side surfaces of the stmts.

[0190] In some examples, all of the surfaces (i.e., interior, exterior, and side surfaces) or only the outer surface 409 of a first row of angled stmts 417a can have radiopaque plating, thus denoting the inlet end 408 of the frame 400.

[0191] In some examples, the outer surface 409 of the frame 400 along each of the angled stmts 417 disposed within a distance d2 from the inlet end 408 can have radiopaque plating, thus forming a radiopaque indicator 470c shown in stippling in FIG. 10. In some examples, the plating that forms the indicator 470c can be formed on any one or more of the outer surfaces of the stmts, the inner surfaces of the stmts, and / or the side surfaces of the stmts within the distance d2.

[0192] In some examples, the distance d2 can be selected to span the fourth row 425 of cells 418a, as shown in FIG. 9. In some examples, the distance d2 can be selected to span the third and fourth rows 423, 425 (i.e., two rows) of cells 418b, 418a. In some examples, the distance d2 can be selected to extend over 40% of the total axial height h2 of the frame 400 from the inlet end 408, where the total axial height h2 extends from the inlet end 408 to the outlet end 410 of the frame 400. In some examples, the distance d2 can be selected to extend at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the total height h2 of the frame 400 from the inlet end 408.

[0193] In some examples, the height d2 of the indicator 470c can be selected to match an axial height of an outer skirt or sealing member, thus denoting the axial position of the outerTHVVA-24038WO01skirt or sealing member on the frame, as previously described. In some examples, the height d2 can be selected to correspond to the portion of the frame that is to be positioned sub-annularly for a desired deployment position, as previously described.

[0194] As described above for the radiopaque indicators 370a-370c and 470a, materials having a second radiopacity that is greater than the first radiopacity of the frame 400 can be selected for use in plating the indicators 470b and 470c shown in FIGS. 9-10. The radiopaque plating material can be selected to maximize contrast between the plated inlet region of the frame 400 and the remaining non-plated regions of the frame for enhanced visibility. In this way, when a user is orienting a prosthetic heart valve comprising the frame 400 for implantation in a native valve, the relative axial position of the plated portions of the frame 400 (the inlet row 425 of cells or a plurality of rows, for example) are clearly visible in contrast to the non-plated portions of the frame 400. Accordingly, the user can adjust the relative axial position of the prosthetic heart valve to achieve a desired deployment position (for example, an 80 / 20 deployment position), to position the outer skirt within the native annulus, and / or to avoid the left branch bundle in the left ventricle.

[0195] In some examples, the frame 400 can comprise one or more radiopaque indicators 470a, the indicator 470b, or both one or more indicators 470a and the indicator 470b.

[0196] In some examples, the frame 400 can comprise one or more radiopaque indicators 470a, the indicator 470c, or both one or more indicators 470a and the indicator 470c.

[0197] In some examples, the frame can comprise only the radiopaque indicator 470b or the radiopaque indicator 470c.

[0198] In some examples, all of the angled stmts 417 and / or the apices 498 at the outflow end 410 of the frame 400 can have radiopaque plating, in lieu of or in addition to other portions of the frame having radiopaque plating as described above. In some examples, selected angled stmts 417 at the outflow end 410 of the frame 400 can have radiopaque plating, in lieu of or in addition to other portions of the frame having radiopaque plating as described above. In some examples, selected apices 498 at the outflow end 410 of the frame 400 can have radiopaque plating, such as only the struts or the apices 498 that form part of a commissure support cell 440.

[0199] As described above, radiopaque metals can be applied to a prosthetic valve frame in plating operations which can integrate radiopaque indicators directly onto the frame structure for assembly ease. Additionally, in many circumstances, these plating operations can yieldTHVVA-24038W001predictable and repeatable plated regions on the frame which can result in improved consistency. Any of various plating processes can be used to form the radiopaque indicators 370a-370c and 470a-470c described herein, such as for example, electroplating, electroless (autocatalytic) plating, immersion plating, carburizing, physical vapor deposition, plasma spray coating, or chemical plating techniques.

[0200] In some examples, selected regions of a frame can be coated in a masking material, leaving remaining portions of the frame unmasked. Masked regions of the frame resist plating while unmasked regions receive plating during the plating operation. In other words, portions of the frame where plating is desired can be left unmasked, thus allowing a radiopaque material to be plated thereon. Accordingly, any region where plating is not desired can be masked. A plating process can be carried out to plate the unmasked portions of the frame, after which the masking material can be removed.

[0201] Any masking process can be used to selectively plate portions of a frame. In some examples, a frame can be fully coated with a masking material in a first step. The masking material can be selectively removed from areas of the frame where plating is desired in a subsequent step, such as by removing the masking material via etching, a solvent, and / or other means.

[0202] In some examples, stencils can be used to apply a masking material or a masking material can be applied with an applicator or with other deposition techniques. In some examples, a plating metal can be deposited directly onto a frame using an applicator.Regardless of plating technique, precise positioning of an integrated radiopaque indicator can be achieved.

[0203] As described above, radiopaque, plated indicators (for example, any radiopaque indicator described herein such as the radiopaque indicators 370a-370c and 470a-470c) can be used during delivery and implantation of a prosthetic heart valve for alignment with anatomical landmarks within or adjacent a native heart valve. Additionally or alternatively, the radiopaque, plated indicators described herein can be used to indicate an orientation or position of a prosthetic valve in a secondary or subsequent procedure after implantation. For example, the radiopaque, plated indicators can be used for alignment in a valve-in-valve procedure, where a prosthetic valve is implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve). Portions of either or both of the previously implanted prosthetic valve and the subsequentTHVVA-24038W001prosthetic valve can be plated with radiopaque materials which can be used for relative alignment therebetween during valve-in-valve implantation.

[0204] In another example, prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. Portions of the prosthetic valve and / or the docking device can have radiopaque plating to assist in relative alignment therebetween during implantation.

[0205] In some examples, subsequent procedures may require navigation of instruments through or around a frame of an implanted prosthetic heart valve for coronary access.Portions of the prosthetic valve frame in areas near arteries can have radiopaque plating to indicate the location of the frame elements for coronary access once the prosthetic valve is implanted. The plated portions of the frame are visible under fluoroscopy, enabling the user to navigate around and / or through the prosthetic valve structure and into the arteries. In this way, as described herein, radiopaque plated prosthetic valve frames can be used to orient a prosthetic valve frame not only during initial delivery and implantation, but during any follow-up procedure.Delivery Apparatus

[0206] FIG. 11 shows a delivery apparatus 500, according to an example, which can be used to implant an expandable prosthetic heart valve, for example, the prosthetic heart valves 100 and 200, or any other prosthetic heart valve described herein, such as those including frames 300 or 400 or any other frame described herein. In some examples, the delivery apparatus 500 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0207] The delivery apparatus 500 in the illustrated example of FIG. 11 is a balloon catheter comprising a handle 502 and a steerable, outer shaft 504 extending distally from the handle 502. The delivery apparatus 500 can further comprise an intermediate shaft 506 (which also may be referred to as a balloon shaft) that extends proximally from the handle 502 and distally from the handle 502, the portion extending distally from the handle 502 also extending coaxially through the outer shaft 504. Additionally, the delivery apparatus 500 can further comprise an inner shaft 508 extending distally from the handle 502 coaxially through the intermediate shaft 506 and the outer shaft 504 and proximally from the handle 502 coaxially through the intermediate shaft 506.

[0208] The outer shaft 504 and the intermediate shaft 506 can be configured to translate (e.g., move) longitudinally, along a central longitudinal axis 520 of the delivery apparatus 500,THVVA-24038W001relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a subject’s body.

[0209] The intermediate shaft 506 can include a proximal end portion 510 that extends proximally from a proximal end of the handle 502, to an adaptor 512. A rotatable knob 514 can be mounted on the proximal end portion 510 and can be configured to rotate the intermediate shaft 506 around the central longitudinal axis 520 and relative to the outer shaft 504.

[0210] The adaptor 512 can include a first port 538 configured to receive a guidewire therethrough and a second port 540 configured to receive fluid (e.g., inflation fluid) from a fluid source. The second port 540 can be fluidly coupled to an inner lumen of the intermediate shaft 506.

[0211] The intermediate shaft 506 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 504 when a distal end of the outer shaft 504 is positioned away from an inflatable balloon 518 of the delivery apparatus 500. A distal end portion of the inner shaft 508 can extend distally beyond the distal end portion of the intermediate shaft 506.

[0212] The balloon 518 can be coupled to the distal end portion of the intermediate shaft 506.

[0213] In some examples, a distal end of the balloon 518 can be coupled to a distal end of the delivery apparatus 500, such as to a nose cone 522 (as shown in FIG. 11), or to an alternate component at the distal end of the delivery apparatus 500 (e.g., a distal shoulder). An intermediate portion of the balloon 518 can overlay a valve mounting portion 524 of a distal end portion of the delivery apparatus 500 and a distal end portion of the balloon 518 can overly a distal shoulder 526 of the delivery apparatus 500. The valve mounting portion 524 and the intermediate portion of the balloon 518 can be configured to receive a prosthetic heart valve in a radially compressed state. For example, as shown schematically in FIG. 11, a prosthetic heart valve 550 (which can be one of the prosthetic valves described herein) can be mounted around the balloon 518, at the valve mounting portion 524 of the delivery apparatus 500.

[0214] The balloon shoulder assembly, including the distal shoulder 526, is configured to maintain the prosthetic heart valve 550 (or any other prosthetic heart valve described herein) at a fixed position on the balloon 518 during delivery through the subject’s vasculature.THVVA-24038W001

[0215] The outer shaft 504 can include a distal tip portion 528 mounted on its distal end. The outer shaft 504 and the intermediate shaft 506 can be translated axially relative to one another to position the distal tip portion 528 adjacent to a proximal end of the valve mounting portion 524, when the prosthetic valve 550 is mounted in the radially compressed state on the valve mounting portion 524 (as shown in FIG. 11) and during delivery of the prosthetic valve to the target implantation site. As such, the distal tip portion 528 can be configured to resist movement of the prosthetic valve 550 relative to the balloon 518 proximally, in the axial direction, relative to the balloon 518, when the distal tip portion 528 is arranged adjacent to a proximal side of the valve mounting portion 524.

[0216] An annular space can be defined between an outer surface of the inner shaft 508 and an inner surface of the intermediate shaft 506 and can be configured to receive fluid from a fluid source via the second port 540 of the adaptor 512. 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 508 and an inner surface of the balloon 518. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the balloon 518 and radially expand and deploy the prosthetic valve 550.

[0217] 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 500 to the target implantation site.

[0218] The handle 502 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 500. In the illustrated example, for example, the handle 502 includes an adjustment member, such as the illustrated rotatable knob 560, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 502 through the outer shaft 504 and has a distal end portion affixed to the outer shaft 504 at or near the distal end of the outer shaft 504. Rotating the knob 560 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 500. Further details on steering or flex mechanisms for the delivery apparatus can be found in U. S. Patent No.9,339,384.

[0219] The handle 502 can further include an adjustment mechanism 561 including an adjustment member, such as the illustrated rotatable knob 562, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 578. TheTHVVA-24038W001adjustment mechanism 561 is configured to adjust the axial position of the intermediate shaft 506 relative to the outer shaft 504 (e.g., for fine positioning at the implantation site). Further details on the delivery apparatus 500 can be found in PCT Publication No. WO2022 / 046585 which is incorporated by reference herein in its entirety.

[0220] A delivery apparatus, for example the delivery apparatus 500, can be used to deliver a prosthetic heart valve (for example, the prosthetic heart valves 100 and 200 or any prosthetic valve described herein) to an implantation site at a native heart valve in a radially crimped configuration, after which a portion of the frame comprising radiopaque plating can be aligned relative to an anatomical landmark within or adjacent the native heart valve under fluoroscopy. Although the delivery apparatus 500 is shown in FIG. 11 with the prosthetic heart valve 550, it is understood that the delivery apparatus 500 may be used with any prosthetic heart valve described herein, such as for example, prosthetic heart valves 100 and 200 or any prosthetic valve comprising a frame, such as for example frames 300 or 400. In this way, selective radiopaque plating can be used to rotationally and / or axially align prosthetic heart valves with portions of a native heart valve or surrounding native anatomy in a reliable and effective manner and with increased accuracy, consistency, and cost efficiency.Delivery Techniques

[0221] 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 (e.g.. 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). Additionally and / or alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aorticvalve. Additionally and / or alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-stemotomy or right parasternalTHVVA-24038WO01mini -thoracotomy, and then advanced through the ascending aorta toward the nati e aortic valve.

[0222] 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. Additionally and / or 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.

[0223] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal encl portion of a delivery apparatus. The prosthetic valve and the distal end portion of the deli very apparatus are inserted into a fernoral 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 va 1 ve / pulmonary artery.

[0224] 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 trans ventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an i ncision 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.

[0225] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a subject’s vasculature. Moreover, the disclosed delivery approachesTHVVA-24038W001are 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.Sterilization

[0226] 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 usable and / or for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals usable and / or 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.Simulation

[0227] Any of the method(s) described herein and any methods of using the systems, assemblies, apparatuses, devices, etc. herein can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can optionally comprise computerized and / or physical representations. 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 (e.g., with the body parts, tissue, etc. being simulated), etc.Additional Examples of the Disclosed Technology

[0228] 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.

[0229] Example 1. A prosthetic heart valve comprising: a radially expandable and compressible annular frame, wherein the frame comprises a plurality of commissure support portions spaced circumferentially apart around the frame; a plurality of leaflets arrangedTHVVA-24038WO01within the frame and forming a plurality of commissures supported by respective commissure support portions: and wherein at least a portion of at least one commissure support portion has a radiopaque plating.

[0230] Example 2. The prosthetic heart valve of any example herein, particularly example 1, wherein the commissure support portions comprise commissure windows, wherein each commissure window comprises a first axially extending commissure support strut, a second axially extending commissure support strut, a first circumferential strut connecting inflow end portions of the first and second axially extending commissure support struts, and a second circumferential strut connecting outflow end portions of the first and second axially extending commissure support struts, and wherein the first axially extending commissure support strut and at least one of the first circumferential strut and the second circumferential strut of at least one of the commissure windows has the radiopaque plating.

[0231] Example 3. The prosthetic heart valve of any example herein, particularly example 2, wherein the plurality of commissures extend through respective commissure windows.

[0232] Example 4. The prosthetic heart valve of any example herein, particularly example 3, wherein the plurality of commissures are secured to the respective commissure windows using stitches.

[0233] Example 5. The prosthetic heart valve of any example herein, particularly example 1, wherein the commissure support portions comprise commissure support cells formed by struts of the frame, and a portion of the struts of at least one of the commissure support cells has the radiopaque plating.

[0234] Example 6. The prosthetic heart valve of any example herein, particularly example 5, wherein the commissure support cells comprise a first angled outflow strut, a second angled outflow strut, a first angled inflow strut, and a second angled inflow strut, and wherein at least one of the first and second angled outflow struts and at least one of the first and second angled inflow struts has the radiopaque plating.

[0235] Example 7. The prosthetic heart valve of any example herein, particularly any one of examples 5-6, wherein the plurality of commissures are secured to respective commissure support cells.

[0236] Example 8. The prosthetic heart valve of any example herein, particularly any one of examples 1-7, wherein the radiopaque plating forms a reflection asymmetric, radiopaque indicator at one or more of the plurality of commissure support portions.THVVA-24038W001

[0237] Example 9. The prosthetic heart valve of any example herein, particularly any one of examples 1-8, wherein the radiopaque plating is on only an exterior surface of the frame at the one or more of the plurality of commissure support portions.

[0238] Example 10. The prosthetic heart valve of any example herein, particularly any one of examples 1 -9, wherein the radiopaque plating comprises one of gold, platinum, tantalum, iridium, palladium, and rhodium.

[0239] Example 11. The prosthetic heart valve of any example herein, particularly any one of examples 1-10, wherein the frame has a height extending from an inlet end to an outlet end of the frame, and an inlet portion of the frame has a radiopaque plating.

[0240] Example 12. The prosthetic heart valve of any example herein, particularly example 11, wherein the radiopaque plating on the inlet portion extends from the inlet end toward the outlet end for at least 20 percent of the height of the frame.

[0241] Example 13. The prosthetic heart valve of any example herein, particularly example 11, wherein the radiopaque plating on the inlet portion extends from the inlet end toward the outlet end for at least 50 percent of the height of the frame.

[0242] Example 14. The prosthetic heart valve of any example herein, particularly example 11, wherein the radiopaque plating on the inlet portion extends from the inlet end toward the outlet end for 5 to 50 percent of the height of the frame.

[0243] Example 15. The prosthetic heart valve of any example herein, particularly any one of examples 11-14, wherein the radiopaque plating is on only an exterior surface of the frame along the inlet portion of the frame.

[0244] Example 16. The prosthetic heart valve of any example herein, particularly any one of examples 11-14, wherein the radiopaque plating is on one or more of an exterior, an interior and / or a side surface of struts that form the inlet portion of the frame.

[0245] Example 17. The prosthetic heart valve of any example herein, particularly any one of examples 11-16, wherein the radiopaque plating comprises one of gold, platinum, tantalum, iridium, palladium, and rhodium.

[0246] Example 18. A prosthetic heart valve comprising: a radially expandable and compressible annular frame, wherein the frame comprises a plurality of angled struts arranged in a plurality of circumferentially extending rows of angled struts forming at least one circumferentially extending row of cells defining an inlet end of the frame; and a plurality of leaflets disposed within the frame and configured to regulate a flow of bloodTHVVA-24038W001through the frame in one direction from the inlet end of the frame to an outlet end of the frame, wherein at least a portion of the cells has a radiopaque plating.

[0247] Example 19. The prosthetic heart valve of any example herein, particularly example 18, wherein the at least one circumferentially extending row of cells comprises a first row of cells at the inlet end of the frame, and wherein every cell of the first row of cells has the radiopaque plating.

[0248] Example 20. The prosthetic heart valve of any example herein, particularly example 1, wherein the at least one circumferentially extending row of cells comprises a second row of cells adjacent the first row of cells, and wherein at least a portion of each cell of the second row of cells has the radiopaque plating.

[0249] Example 21. The prosthetic heart valve of any example herein, particularly example 18, wherein the plurality of rows of angled struts include a first row of angled struts at the inlet end of the frame, wherein the struts of the first row of angled struts has radiopaque plating.

[0250] Example 22. The prosthetic heart valve of any example herein, particularly any one of examples 18-21, wherein the frame further comprises radiopaque plating forming at least one radiopaque indicator on a commissure support portion of the frame.

[0251] Example 23. A prosthetic heart valve comprising: a radially expandable and compressible annular frame having a plurality of struts comprising a first metal having a first radiopacity; a plurality of leaflets disposed within the frame and configured to regulate a flow of blood through the frame in one direction from an inlet end of the frame to an outlet end of the frame; and wherein one or more selected struts of the plurality of struts are plated with a second metal having a second radiopacity that is greater than the first radiopacity.

[0252] Example 24. The prosthetic heart valve of any example herein, particularly example 23, wherein the first metal is cobalt-chromium.

[0253] Example 25. The prosthetic heart valve of any example herein, particularly any one of examples 23-24, wherein the second metal is gold or platinum.

[0254] Example 26. The prosthetic heart valve of any example herein, particularly any one of examples 23-25, wherein the one or more selected struts form at least one reflection asymmetric, radiopaque indicator.THVVA-24038WO01

[0255] Example 27. The prosthetic heart valve of any example herein, particularly any one of examples 23-26, wherein the one or more selected struts form a circumferential arrangement of struts around the frame.

[0256] Example 28. An expandable frame for a prosthetic heart valve, the frame comprising: a plurality of struts comprising a first metal having a first radiopacity, wherein one or more selected struts are plated with a second metal having a second radiopacity that is greater than the first radiopacity.

[0257] Example 29. The frame of any example herein, particularly example 28, wherein the one or more selected struts form at least a section of a commissure support portion of the frame.

[0258] Example 30. The frame of any example herein, particularly example 29, wherein the one or more selected struts form a reflection asymmetric, radiopaque indicator at the commissure support portion.

[0259] Example 31. The frame of any example herein, particularly example 30, wherein the reflection asymmetric, radiopaque indicator forms a C shape, a backwards C shape, an uppercase gamma shape, a backwards uppercase gamma shape, an L shape, or a backwards L shape when viewed from outside of the frame.

[0260] Example 32. The frame of any example herein, particularly example 29, wherein the commissure support portion comprises a commissure window that includes the one or more selected struts.

[0261] Example 33. The frame of any example herein, particularly example 32, wherein each commissure window comprises a first axially extending commissure support strut, a second axially extending commissure support strut, a first circumferential strut connecting inflow end portions of the first and second axially extending commissure support struts, and a second circumferential strut connecting outflow end portions of the first and second axially extending commissure support struts, and wherein the first axially extending commissure support strut and at least one of the first circumferential strut and the second circumferential strut of at least one of the commissure windows includes the one or more selected stmts.

[0262] Example 34. The frame of any example herein, particularly example 33, wherein the first axially extending commissure support strut, the first circumferential strut, and the second circumferential strut of at least one of the commissure windows includes the one or more selected struts.THVVA-24038W001

[0263] Example 35. The frame of any example herein, particularly any one of examples 33-34, wherein the first axially extending commissure support strut, the first circumferential strut, and the second circumferential strut of each of the commissure windows includes the one or more selected struts.

[0264] Example 36. The frame of any example herein, particularly example 29, wherein the frame comprises a plurality of cells defined by the plurality of struts, and the commissure support portion comprises a selected cell of the plurality of cells, wherein the selected cell includes the one or more selected struts.

[0265] Example 37. The frame of any example herein, particularly any one of examples 28-36, wherein the one or more selected struts are plated with the second metal on only an exterior surface of the frame.

[0266] Example 38. The frame of any example herein, particularly any one of examples 28-36, wherein the one or more selected struts are plated with the second metal on all sides of the one or more selected struts.

[0267] Example 39. The frame of any example herein, particularly example 28, wherein the one or more selected struts comprise at least a portion of the struts forming an inlet end portion of the expandable frame.

[0268] Example 40. An annular, expandable frame for a prosthetic heart valve, the frame comprising: a plurality of struts, wherein one or more selected struts of the plurality of struts has radiopaque plating.

[0269] Example 41. The frame of any example herein, particularly example 40, wherein the one or more selected struts comprises struts forming a row of cells at an inlet end of the frame.

[0270] Example 42. The frame of any example herein, particularly example 40, wherein the one or more selected struts comprises struts forming two rows of cells at an inlet end of the frame.

[0271] Example 43. The frame of any example herein, particularly example 40, wherein the frame has a height extending from an inlet end to an outlet end of the frame, and wherein the radiopaque plating extends at least 20 percent of the height of the frame from the inlet end.

[0272] Example 44. The frame of any example herein, particularly example 43, wherein the radiopaque plating extends up to 80 percent of the height of the frame from the inlet end.THVVA-24038W001

[0273] Example 45. The frame of any example herein, particularly any one of examples 43-44, wherein the radiopaque plating extends between 20-60 percent of the height of the frame from the inlet end.

[0274] Example 46. The frame of any example herein, particularly any one of examples 43-44, wherein the radiopaque plating extends between 30-50 percent of the height of the frame from the inlet end.

[0275] Example 47. The frame of any example herein, particularly any one of examples 43-44, wherein the radiopaque plating extends between 40-50 percent of the height of the frame from the inlet end.

[0276] Example 48. The frame of any example herein, particularly example 43, wherein the radiopaque plating extends 50 percent of the height of the frame from the inlet end.

[0277] Example 49. The frame of any example herein, particularly any one of examples 40-48, wherein the one or more selected struts have radiopaque plating on only an exterior surface of the frame.

[0278] Example 50. The frame of any example herein, particularly any one of examples 40-48, wherein the one or more selected struts have radiopaque plating on one or more of an exterior, an interior and / or a side surface of the one or more selected struts.

[0279] Example 51. The frame of any example herein, particularly any one of examples 40-48, wherein the one or more selected struts comprise struts that are configured as axially extending commissure supports forming portions of at least one commissure window.

[0280] Example 52. The frame of any example herein, particularly example 51, wherein the at least one commissure window comprises a first axially extending commissure support strut, a second axially extending commissure support strut, a first circumferential strut extending between inflow end portions of the first and second axially extending commissure support struts, and a second circumferential strut extending between outflow end portions of the first and second axially extending commissure support struts, and wherein the one or more selected struts includes the first axially extending commissure support strut, the first circumferential strut, and the second circumferential strut.

[0281] Example 53. The frame of any example herein, particularly any one of examples 40-48, wherein the one or more selected struts comprise struts that are configured as commissure supports forming portions of at least one commissure support cell.THVVA-24038W001

[0282] Example 54. The frame of any example herein, particularly example 53, wherein the at least one commissure support cell comprises a first angled outflow strut, a second angled outflow strut, a first angled inflow strut, and a second angled inflow strut, and wherein the one or more selected struts includes at least one of the first and second angled outflow struts and at least one of the first and second angled inflow struts.

[0283] Example 55. The frame of any example herein, particularly example 40, wherein the one or more selected struts comprise struts that are configured as commissure supports and / or struts forming a row of cells at an inlet end of the frame.

[0284] Example 56. A method of implanting a prosthetic heart valve, the method comprising: delivering the prosthetic heart valve to an implantation site at a native heart valve in a radially crimped configuration, wherein the prosthetic heart valve comprises a radially expandable frame comprising a radiopaque plating; aligning the radiopaque plating relative to an anatomical landmark within or adjacent the native heart valve under fluoroscopy; and expanding the prosthetic heart valve into a radially expanded configuration at the implantation site.

[0285] Example 57. The method of any example herein, particularly example 56, wherein the frame comprises a plurality of commissure support portions, wherein at least one of the commissure support portions includes the radiopaque plating, and the act of aligning the portion of the frame comprises rotationally aligning the radiopaque plating with a commissure of the native heart valve.

[0286] Example 58. The method of any example herein, particularly example 57, wherein the radiopaque plating comprises a reflection asymmetric, radiopaque indicator.

[0287] Example 59. The method of any example herein, particularly any one of examples 56-58, wherein the frame comprises an inlet region with a radiopaque plating, and the act of aligning the portion of the frame comprises axially aligning the plated, inlet region of the frame within an annulus the native heart valve.

[0288] Example 60. The method of any example herein, particularly any one of examples 56-59, wherein the frame comprises a plurality of struts and selected struts of the plurality of struts have the radiopaque plating, and the act of aligning the portion of the frame comprises rotationally aligning the radiopaque plating with a coronary artery.

[0289] Example 61. A method comprising: plating a portion of a prosthetic heart valve frame with a radiopaque material, wherein the frame comprises a first metal having a firstTHVVA-24038WO01radiopacity and the radiopaque material comprises a second metal having a second radiopacity greater than the first radiopacity.

[0290] Example 62. The method of any example herein, particularly example 61, further comprising masking the prosthetic heart valve frame to form a masked region and an unmasked region of the frame.

[0291] Example 63. The method of any example herein, particularly example 62, wherein the act of masking the frame comprises applying a masking material to the frame to form the masked region.

[0292] Example 64. The method of any example herein, particularly example 63, wherein the act of masking the frame comprises selectively removing the masking material to form the unmasked region.

[0293] Example 65. The method of any example herein, particularly any one of examples 62-64, wherein the act of plating a portion of the frame comprises changing a radiopacity of the unmasked region from the first radiopacity to the second radiopacity.

[0294] Example 66. The method of any example herein, particularly any one of examples 61-65, wherein the prosthetic heart valve frame comprises a plurality of commissure support portions spaced circumferentially apart around the frame, and the portion of a prosthetic heart valve frame with the radiopaque material comprises a region of at least one of the plurality of commissure support portions.

[0295] Example 67. The method of any example herein, particularly example 66, wherein each of the plurality of commissure support portions is plated with the radiopaque material.

[0296] Example 68. The method of any example herein, particularly any one of examples 61-65, wherein the prosthetic heart valve frame comprises a plurality of struts arranged in a plurality of circumferentially extending rows of struts forming at least one circumferentially extending row of cells defining an inlet end of the frame, wherein the at least one circumferentially extending row of cells comprises a first row of cells at the inlet end of the frame and a second row of cells adjacent the first row of cells, and wherein the portion of a prosthetic heart valve frame with the radiopaque material comprises struts forming the first row of cells or both the first and second rows of cells.

[0297] Example 69. The method of any example herein, particularly any one of examples 61-65, wherein the prosthetic heart valve frame comprises a plurality of struts arranged in a plurality of circumferentially extending rows of struts forming at least one circumferentiallyTHVVA-24038W001extending row of cells defining an inlet end of the frame, wherein the portion of a prosthetic heart valve frame with the radiopaque material comprises struts forming a first row of struts at the inlet end of the frame.

[0298] Example 70. The method of any example herein, particularly any one of examples 61-65, wherein the prosthetic heart valve frame comprises a plurality of commissure support portions spaced circumferentially apart around the frame and a plurality of struts arranged in a plurality of circumferentially extending rows of struts forming a first circumferentially extending row of cells at an inlet end of the frame and a second circumferentially extending row of cells adjacent the first row of cells, and wherein the portion of a prosthetic heart valve frame with the radiopaque material comprises a region of at least one of the plurality of commissure support portions and / or struts forming the first row of cells or both the first and second rows of cells.

[0299] Example 71. The method of any example herein, particularly any one of examples 61-67, wherein the act of plating a portion of the frame comprises coating portions of only an exterior surface of the frame with the second metal.

[0300] Example 72. The method of any example herein, particularly any one of examples 61-71, wherein the first metal is cobalt-chromium.

[0301] Example 73. The method of any example herein, particularly any one of examples 61-72, wherein the second metal is one of gold, platinum, iridium, tantalum, palladium, and rhodium.

[0302] Example 74. The method of any example herein, particularly any one of examples 61-73, further comprising arranging a plurality of leaflets within the frame and securing commissures of the leaflets to the frame.

[0303] Example 75. The method of any example herein, particularly any one of examples 61-74, wherein the act of plating a portion of the frame comprises electroplating the portion of the frame with the radiopaque material.

[0304] Example 76. A method comprising sterilizing the prosthetic heart valve, frame, apparatus, and / or assembly of any example.

[0305] Example 77. A method comprising performing a simulation on a living animal or on a non-living simulation using the prosthetic heart valve, frame, apparatus, radiopaque plating and / or assembly of any example.THVVA-24038W001

[0306] Example 78. A prosthetic heart valve, frame, apparatus, and / or assembly of any one of examples 1-75, wherein the prosthetic heart valve, frame, apparatus, and / or assembly is sterilized.

[0307] 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 valve frame, prosthetic valve, and radiopaque plating method and / or indicator can be combined with any one or more features of another prosthetic valve frame, prosthetic valve, and radiopaque plating method and / or indicator. As another example, any one or more features of one delivery apparatus can be combined with any one or more features of another delivery apparatus.

[0308] 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

THVVA-24038W001WE CLAIM:

1. A prosthetic heart valve comprising:a radially expandable and compressible annular frame having a plurality of struts comprising a first metal having a first radiopacity;a plurality of leaflets disposed within the frame and configured to regulate a flow of blood through the frame in one direction from an inlet end of the frame to an outlet end of the frame, wherein the plurality of leaflets form a plurality of commissures supported by the frame; andwherein one or more selected struts of the plurality of struts are plated with a second metal having a second radiopacity that is greater than the first radiopacity.

2. The prosthetic heart valve of claim 1, wherein the one or more selected struts form at least one reflection asymmetric, radiopaque indicator.

3. The prosthetic heart valve of any one of claims 1-2, wherein the one or more selected stmts form a circumferential arrangement of struts around the frame.

4. The prosthetic heart valve of any one of claims 1-3, wherein the frame comprises a plurality of commissure windows configured to support the plurality of commissures, wherein each commissure window comprises a first axially extending commissure support stmt, a second axially extending commissure support stmt, a first circumferential stmt connecting inflow end portions of the first and second axially extending commissure support stmts, and a second circumferential stmt connecting outflow end portions of the first and second axially extending commissure support stmts, and wherein the one or more selected stmts include the first axially extending commissure support stmt and at least one of the first circumferential stmt and the second circumferential stmt of at least one of the commissure windows.

5. The prosthetic heart valve of claim 4, wherein the one or more selected stmts include the first axially extending commissure support stmt, the first circumferential stmt, and the second circumferential stmt of at least one of the commissure windows.THVVA-24038W0016. The prosthetic heart valve of any one of claims 1-3, wherein the frame comprises commissure support cells formed by the struts of the frame and configured to support the plurality of commissures, wherein the one or more selected struts include one or more struts of one or more selected cells of the commissure support cells.

7. The prosthetic heart valve of any one of claims 1-6, wherein the one or more selected struts are plated with the second metal on only an exterior surface of the frame.

8. The prosthetic heart valve of any one of claims 1-6, wherein the one or more selected struts are plated with the second metal on all sides of the one or more selected struts.

9. An annular, expandable frame for a prosthetic heart valve, the frame comprising:a plurality of struts, wherein one or more selected struts of the plurality of struts has radiopaque plating.

10. The frame of claim 9, wherein the one or more selected struts comprises struts forming a row of cells at an inlet end of the frame.

11. The frame of claim 9, wherein the one or more selected struts comprises struts forming two rows of cells at an inlet end of the frame.

12. The frame of claim 9, wherein the frame has a height extending from an inlet end to an outlet end of the frame, and wherein the radiopaque plating extends at least 20 percent of the height of the frame from the inlet end.

13. The frame of claim 12, wherein the radiopaque plating extends up to 80 percent of the height of the frame from the inlet end.THVVA-24038WO0114. The frame of any one of claims 9-13. wherein the one or more selected struts comprise struts that are configured as axially extending commissure supports forming portions of at least one commissure window.

15. The frame of claim 14, wherein the at least one commissure window comprises a first axially extending commissure support stmt, a second axially extending commissure support stmt, a first circumferential stmt extending between inflow end portions of the first and second axially extending commissure support stmts, and a second circumferential stmt extending between outflow end portions of the first and second axially extending commissure support stmts, and wherein the one or more selected stmts includes the first axially extending commissure support stmt, the first circumferential stmt, and the second circumferential stmt.

16. The frame of any one of claims 9-13, wherein the one or more selected struts comprise struts that are configured as commissure supports forming portions of at least one commissure support cell.

17. The frame of claim 16, wherein the at least one commissure support cell comprises a first angled outflow stmt, a second angled outflow stmt, a first angled inflow stmt, and a second angled inflow stmt, and wherein the one or more selected stmts includes at least one of the first and second angled outflow stmts and at least one of the first and second angled inflow stmts.

18. The frame of claim 9, wherein the one or more selected struts comprise struts that are configured as commissure supports and / or struts forming a row of cells at an inlet end of the frame.

19. A method of implanting a prosthetic heart valve, the method comprising: delivering the prosthetic heart valve to an implantation site at a native heart valve in a radially crimped configuration, wherein the prosthetic heart valve comprises a radially expandable frame comprising a radiopaque plating;THVVA-24038WO01aligning the radiopaque plating relative to an anatomical landmark within or adjacent the native heart valve under fluoroscopy; andexpanding the prosthetic heart valve into a radially expanded configuration at the implantation site.

20. A method comprising:plating a portion of a prosthetic heart valve frame with a radiopaque material, wherein the frame comprises a first metal having a first radiopacity and the radiopaque material comprises a second metal having a second radiopacity greater than the first radiopacity.

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