Systems and methods for aligning a commissure of a prosthetic valve with a commissure of a native valve

Abstract

Systems and methods for aligning commissures of a prosthetic valve with commissures of a native valve, for various imaging views, are disclosed. As an example, a delivery apparatus includes a rotatable first shaft that is configured to rotate around a central longitudinal axis of the delivery apparatus to rotationally align a prosthetic valve mounted on the delivery apparatus with native anatomy at a target implantation site. The delivery apparatus further includes a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft, a polymeric body mounted on the distal end portion of the second shaft, a first radiopaque marker disposed on the polymeric body, and a second radiopaque marker disposed on the polymeric body, where the first and second radiopaque markers are spaced circumferentially apart from one another.

Description

SYSTEMS AND METHODS FOR ALIGNING A COMMISSURE OF A PROSTHETIC VALVE WITH A COMMISSURE OF A NATIVE VALVE CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 624,399, filed January 24, 2024, which is incorporated by reference herein in its entirety. FIELD

[0002] The present disclosure relates to apparatuses, systems, and methods for mounting a prosthetic valve onto a delivery apparatus and deploying the prosthetic valve at a native valve such that a commissure of the prosthetic valve is aligned with a commissure of the native valve. 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. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (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.

[0004] It may be desirable to deploy the prosthetic valve at the native valve using the delivery apparatus such that commissures of the prosthetic valve are aligned withcommissures of the native valve. However, such alignment can be complicated and differ based on user preferences and / or patient anatomy. Accordingly, a need exists for improved systems and methods for positioning radially expandable prosthetic heart valves relative to the native anatomy. SUMMARY

[0005] Described herein are examples of systems and methods for implanting a prosthetic valve at a native valve of a heart of a patient with at least one commissure of the prosthetic valve in alignment with a commissure of the native valve. In some examples, the prosthetic valve can be mounted in a radially compressed state onto a delivery apparatus for delivery to a target implantation site and then deployed at the target implantation site (e.g., the native valve) with the delivery apparatus. In some examples, the delivery apparatus can include an inflatable balloon and the prosthetic valve can be radially expanded and deployed by inflating the balloon at the target implantation site. After reaching the native valve, an asymmetric marker configured to be visualized under fluoroscopic imaging, which is disposed on a distal end portion of the delivery apparatus and corresponds to a location of a commissure of the prosthetic valve, can be aligned with a commissure of the native valve in the selected imaging view such that after deploying the prosthetic valve, the commissures of the prosthetic valve are aligned (for example, in a circumferential direction) with commissures of the native valve. In some examples, systems for mounting the prosthetic heart valve onto the delivery apparatus can be configured to mount the prosthetic heart valve with various offsets from the asymmetric marker on the delivery apparatus which are based on the imaging view to be used during the implantation procedure. In some examples, the delivery apparatus can include two or more asymmetric markers, where each asymmetric corresponds to a different selected imaging view to be used during the implantation procedure, which results in the prosthetic valve being implanted in the native valve with commissures aligned. In this way, the disclosed systems, delivery apparatuses, and methods can, for example, provide the ability to implant a prosthetic valve easily and effectively at a native valve with commissures aligned with one another while utilizing different imaging views. 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.

[0006] A delivery apparatus for a prosthetic implant can comprise a handle and one or more shafts coupled to the handle.

[0007] In some examples, a polymeric body can be mounted on a distal end portion of a shaft of the delivery apparatus.

[0008] In some examples, a first radiopaque marker is disposed on the polymeric body.

[0009] In some examples, the first radiopaque marker is reflection asymmetric along an axis that is parallel to a central longitudinal axis of the delivery apparatus.

[0010] In some examples, a second radiopaque marker is disposed on the polymeric body and the first and second radiopaque markers are spaced apart from one another in a circumferential direction.

[0011] In some examples, the second radiopaque marker is reflection asymmetric along an axis that is parallel to the central longitudinal axis.

[0012] In some examples, the delivery apparatus includes a rotatable first shaft and a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft.

[0013] In some examples, the polymeric body is mounted on the distal end portion of the second shaft.

[0014] In some examples, a delivery apparatus comprises a rotatable first shaft that is configured to rotate around a central longitudinal axis of the delivery apparatus to rotationally align a prosthetic valve mounted on the delivery apparatus with native anatomy at a target implantation site, a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft, a polymeric body mounted on the distal end portion of the second shaft, a first radiopaque marker disposed on the polymeric body, and a second radiopaque marker disposed on the polymeric body. The first and second radiopaque markers are spaced circumferentially apart from one another.

[0015] In some examples, a delivery apparatus comprises a first radiopaque marker positioned along a distal end portion of the delivery apparatus, and a second radiopaque marker positioned along the distal end portion of the delivery apparatus. The first and second radiopaque markers are spaced apart from one another in a circumferential direction. The first and second radiopaque markers are reflection asymmetric along an axis that is parallel to the central longitudinal axis.

[0016] In some examples, a delivery apparatus comprises one or more of the components recited in Examples 1-17 and 20-33 below.

[0017] An assembly can comprise a prosthetic heart valve and a delivery apparatus.

[0018] In some examples, the delivery apparatus comprises a shaft extending distally from a handle.

[0019] In some examples, the prosthetic heart valve is mounted on a valve mounting portion of a distal end portion of the shaft.

[0020] In some examples, the delivery apparatus includes a polymeric body mounted to a distal end portion of the shaft and the polymeric body is offset axially from the valve mounting portion.

[0021] In some examples, first and second radiopaque markers are disposed on or in the polymeric body, wherein the first and second radiopaque markers are circumferentially offset from one another.

[0022] In some examples, the first and second radiopaque markers are asymmetric markers.

[0023] In some examples, an assembly comprises the delivery apparatus of any one of Examples 1-17 and further comprising a prosthetic heart valve mounted in a radially compressed configuration onto and around a valve mounting portion of the distal end portion of the second shaft, wherein the polymeric body is axially offset from the prosthetic heart valve.

[0024] In some examples, an assembly comprises the delivery apparatus of any one of Examples 20-33 and further comprising a prosthetic heart valve mounted in a radially compressed configuration onto and around a valve mounting portion of the distal end portion of the shaft, wherein the polymeric body is axially offset from the prosthetic heart valve.

[0025] In some examples, an assembly comprises one or more of the components recited in Examples 18-19, 34-35, and 77 below.

[0026] An assembly can comprise a crimping device and a positioning device configured to couple to the crimping device.

[0027] In some examples, the positioning device is configured to couple to the crimping device in two different circumferential or rotational orientations that correspond to different imaging views to be used during a prosthetic valve implantation procedure.

[0028] In some examples, the crimping device has a channel and an opening to the channel on a first face of the crimping device, where the opening includes a plurality of circumferentially spaced apart slots.

[0029] In some examples, the first face includes a first indicator and a second indicator spaced circumferentially apart from one another adjacent to the opening.

[0030] In some examples, the positioning device can comprise a body and a flange extending radially outward from the body at a distal end of the positioning device, where the flange comprises a plurality of circumferentially spaced apart extension portions.

[0031] In some examples, the flange of the positioning device can include first and second indicating elements.

[0032] In some examples, the first indicating element is disposed adjacent to a first extension portion of the plurality of extension portions and the second indicating element is disposed adjacent to a second extension portion of the plurality of extension portions.

[0033] In some examples, the plurality of extension portions is configured to couple to the plurality of slots in two different orientations.

[0034] In some examples, in a first orientation the first indicating element is aligned with the second indicator of the crimping device, and in a second orientation the second indicating element is aligned with the second indicator of the crimping device.

[0035] In some examples, an assembly comprises a crimping device having a channel and an opening to the channel on a first face of the crimping device, where the opening includes a plurality of circumferentially spaced apart slots, and where the first face includes a first indicator and a second indicator spaced circumferentially apart from one another adjacent to the opening. The assembly further comprises a positioning device comprising a body and a flange extending radially outward from the body at a distal end of the positioning device, where the flange comprises a plurality of circumferentially spaced apart extension portions and first and second indicating elements, where the first indicating element is disposed adjacent to a first extension portion of the plurality of extension portions and the second indicating element is disposed adjacent to a second extension portion of the plurality of extension portions. The plurality of extension portions is configured to couple to the plurality of slots in two different orientations, where in a first orientation the first indicating element is aligned with the second indicator of the crimping device, and where in a second orientation the second indicating element is aligned with the second indicator of the crimping device.

[0036] In some examples, an assembly comprises a delivery apparatus for a prosthetic device comprising a shaft and a valve mounting portion along a portion of the shaft, a crimping device having a channel and an opening to the channel on a first face of the crimping device, where the opening includes a plurality of circumferentially spaced apart slots, and a positioning device comprising a body and a flange extending radially outward from the bodyat a distal end of the positioning device. The body is configured to couple to the shaft, proximal to the valve mounting portion, where the flange comprises a plurality of circumferentially spaced apart extension portions, and where the plurality of extension portions is configured to mate with the plurality of slots in two different orientations which are circumferentially offset from one another.

[0037] In some examples, an assembly comprises one or more of the components recited in Examples 52-66 below.

[0038] A method can comprise selecting a fluoroscopic imaging view out of two or more possible fluoroscopic imaging views to be used during an implantation procedure and selecting a first radiopaque marker out of two or more radiopaque markers based on the selected imaging view.

[0039] In some examples, the two or more radiopaque markers are circumferentially offset from one another on a distal end portion of a delivery apparatus.

[0040] In some examples, the two or more radiopaque markers are circumferentially offset from one another on a polymeric body mounted on a distal end portion of a shaft of a delivery apparatus.

[0041] In some examples, the method can include advancing the distal end portion of the shaft of the delivery apparatus toward a native valve of a heart, where a prosthetic heart valve is radially compressed around the distal end portion of the delivery apparatus, at a valve mounting portion of the delivery apparatus.

[0042] In some examples, the method can include visualizing in the selected fluoroscopic imaging view, a position of the first radiopaque marker relative to a guidewire extending through the shaft.

[0043] In some examples, the first radiopaque marker is asymmetric.

[0044] In some examples, the method can include rotating the shaft of the delivery apparatus, which rotates the prosthetic heart valve and the first radiopaque marker, until the first radiopaque marker is centered along the guidewire and is in a predetermined orientation in the selected fluoroscopic imaging view.

[0045] In some examples, the method can include radially expanding and implanting the prosthetic heart valve in the native valve such that commissures of the prosthetic heart valve are aligned with commissures of the native valve.

[0046] In some examples, a method comprises advancing a distal end portion of a delivery apparatus toward a native valve of a heart, where a prosthetic heart valve is radially compressed around a distal end portion of the delivery apparatus, at a valve mounting portion of the delivery apparatus. The method further comprises selecting a fluoroscopic imaging view out of a first fluoroscopic imaging view and a second fluoroscopic imaging view to be used during an implantation procedure. For a first fluoroscopic imaging view, the method includes: visualizing under fluoroscopy, a position of a first radiopaque marker positioned along a distal end portion of a shaft of the delivery apparatus relative to a guidewire extending through the shaft, where the first radiopaque marker is reflection asymmetric along an axis that is parallel to a central longitudinal axis of the delivery apparatus; rotating the shaft of the delivery apparatus, which rotates the prosthetic heart valve and the first radiopaque marker, until the first radiopaque marker is centered along the guidewire and is in a predetermined orientation in the first fluoroscopic imaging view; and radially expanding the prosthetic heart valve to implant the prosthetic heart valve in the native valve such that commissures of the prosthetic heart valve are aligned with commissures of the native valve. For a second fluoroscopic imaging view, the method includes visualizing under fluoroscopy, a position of a second radiopaque marker positioned along the distal end portion of the shaft of the delivery apparatus relative to the guidewire extending through the shaft, where the second radiopaque marker is circumferentially offset from the first radiopaque marker, and wherein the second radiopaque marker is reflection asymmetric along an axis that is parallel to the central longitudinal axis of the delivery apparatus; rotating the shaft of the delivery apparatus, which rotates the prosthetic heart valve and the second radiopaque marker, until the second radiopaque marker is centered along the guidewire and is in a predetermined orientation in the second fluoroscopic imaging view; and radially expanding the prosthetic heart valve to implant the prosthetic heart valve in the native valve such that commissures of the prosthetic heart valve are aligned with commissures of the native valve.

[0047] In some examples, a method comprises advancing a distal end portion of a delivery apparatus toward a native valve of a heart, where a prosthetic heart valve is radially compressed around an inflatable balloon of the delivery apparatus, at a valve mounting portion of the delivery apparatus. The method further comprises, for a first fluoroscopic imaging view, visualizing under fluoroscopy, a position of a first radiopaque marker disposed on a polymeric body mounted on a distal end portion of a shaft of the delivery apparatusrelative to a guidewire extending through the shaft, where the first radiopaque marker is reflection asymmetric along an axis that is parallel to a central longitudinal axis of the delivery apparatus, rotating the shaft of the delivery apparatus, which rotates the prosthetic heart valve and the first radiopaque marker, until the first radiopaque marker is centered along the guidewire and is in a predetermined orientation in the first fluoroscopic imaging view, and inflating the balloon to radially expand and implant the prosthetic heart valve in the native valve such that commissures of the prosthetic heart valve are aligned with commissures of the native valve. The method further comprises, for a second fluoroscopic imaging view, visualizing under fluoroscopy, a position of a second radiopaque marker disposed on the polymeric body of the delivery apparatus relative to a guidewire extending through the shaft, where the second radiopaque marker is circumferentially offset from the first radiopaque marker, and where the second radiopaque marker is reflection asymmetric along an axis that is parallel to the central longitudinal axis of the delivery apparatus, rotating the shaft of the delivery apparatus, which rotates the prosthetic heart valve and the second radiopaque marker, until the second radiopaque marker is centered along the guidewire and is in a predetermined orientation in the second fluoroscopic imaging view, and inflating the balloon to radially expand and implant the prosthetic heart valve in the native valve such that commissures of the prosthetic heart valve are aligned with commissures of the native valve.

[0048] In some examples, a method comprises selecting a fluoroscopic imaging view out of two or more possible fluoroscopic imaging views to be used during an implantation procedure and selecting a first radiopaque marker out of two or more radiopaque markers based on the selected imaging view, where the two or more radiopaque markers are circumferentially offset from one another on a polymeric body mounted on a distal end portion of a shaft of a delivery apparatus. The method further comprises advancing the distal end portion of the shaft of the delivery apparatus toward a native valve of a heart, where a prosthetic heart valve is radially compressed around an inflatable balloon of the delivery apparatus, at a valve mounting portion of the delivery apparatus, and visualizing in the selected fluoroscopic imaging view, a position of the first radiopaque marker relative to a guidewire extending through the shaft, where the first radiopaque marker is reflection asymmetric along an axis that is parallel to a central longitudinal axis of the delivery apparatus. The method further comprises rotating the shaft of the delivery apparatus, which rotates the prosthetic heart valve and the first radiopaque marker, until the first radiopaquemarker is centered along the guidewire and is in a predetermined orientation in the selected fluoroscopic imaging view, and inflating the balloon to radially expand and implant the prosthetic heart valve in the native valve such that commissures of the prosthetic heart valve are aligned with commissures of the native valve.

[0049] In some examples, a method comprises one or more of the features recited in Examples 36-51 and 76 below.

[0050] A method can comprise coupling a positioning device to a delivery apparatus and coupling the positioning device to a crimping device in a selected circumferential orientation out of two possible circumferential orientations.

[0051] In some examples, the method can include coupling a body of the positioning device to a shaft of the delivery apparatus, adjacent to a valve mounting portion of the delivery apparatus.

[0052] In some examples, the positioning device comprises a flange extending radially outward from the body and the flange comprises a plurality of circumferentially spaced apart extension portions.

[0053] In some examples, the method can include, for a first fluoroscopic imaging view to be used during a first implantation procedure with the delivery apparatus, coupling the flange to a side of the crimping device such that the plurality of extension portions mate with a plurality of complementary slots in an opening to a channel of the crimping device and the valve mounting portion of the delivery apparatus is held within the channel in a first circumferential orientation.

[0054] In some examples, the method can include, for a second fluoroscopic imaging view to be used during a second implantation procedure with the delivery apparatus, coupling the flange to the side of the crimping device such that the plurality of extension portions mate with the plurality of complementary slots and the valve mounting portion of the delivery apparatus is held within the channel in a second circumferential orientation.

[0055] In some examples, a method comprises coupling a body of a positioning device to a shaft of a delivery apparatus, adjacent to a valve mounting portion of the delivery apparatus, where the positioning device comprises a flange extending radially outward from the body at a distal end of the positioning device, and where the flange comprises a plurality of circumferentially spaced apart extension portions. The method further comprises selecting between a first fluoroscopic imaging view and a second fluoroscopic imaging view to be usedduring an implantation procedure with the delivery apparatus. The method further comprises, for a first fluoroscopic imaging view to be used during a first implantation procedure with the delivery apparatus, coupling the flange to a side of a crimping device such that the plurality of extension portions mate with a plurality of complementary slots in an opening to a channel of the crimping device and the valve mounting portion of the delivery apparatus is held within the channel in a first circumferential orientation. The method further comprises, for a second fluoroscopic imaging view to be used during a second implantation procedure with the delivery apparatus, coupling the flange to the side of the crimping device such that the plurality of extension portions mate with the plurality of complementary slots and the valve mounting portion of the delivery apparatus is held within the channel in a second circumferential orientation.

[0056] In some examples, a method comprises one or more of the features recited in Examples 67-75 below.

[0057] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, or simulator (e.g., with body parts, heart, tissue, etc. being simulated).

[0058] 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

[0059] FIG.1A is a perspective view of a prosthetic heart valve, according to an example.

[0060] FIG.1B is a perspective view of the prosthetic valve of FIG.1A with the components on the outside of the frame shown in transparent lines for purpose of illustration.

[0061] FIG.2A is a side view of an exemplary delivery apparatus configured to deliver and implant a radially expandable prosthetic heart valve at an implantation site.

[0062] FIG.2B is a cross-sectional side view of a distal end portion of the delivery apparatus of FIG.2A.

[0063] FIG.2C is a side view of the distal end portion of the delivery apparatus of FIG.2A, with a first radiopaque marker disposed on a distal shoulder of the delivery apparatus.

[0064] FIG.3 is an exemplary fluoroscopic image depicting the first radiopaque marker of the delivery apparatus of FIG.2C aligned with a guidewire extending through the delivery apparatus.

[0065] FIG.4A is a cross-sectional view of an aortic valve illustrating a first positioning of a prosthetic valve within the aortic valve where commissures of the prosthetic valve at least partially block one or more openings to the coronary arteries.

[0066] FIG.4B is a cross-sectional view of an aortic valve illustrating a second positioning of a prosthetic valve within the aortic valve where commissures of the prosthetic valve are circumferentially aligned with native commissure of the aortic valve, thereby maintaining access to the coronary arteries.

[0067] FIG.5A is a schematic of an example of a three-cusp imaging view of a native valve which can be used for visualizing a delivery apparatus in a patient’s heart during an implantation procedure and rotationally aligning a prosthetic valve mounted on the delivery apparatus.

[0068] FIG.5B is a cross-sectional view of a native valve, illustrating a location of commissures of the native valve within the imaging view of FIG.5A.

[0069] FIG.6A is a schematic of an example of a cusp overlap imaging view of a native valve which can be used for visualizing a delivery apparatus in a patient’s heart during an implantation procedure and rotationally aligning a prosthetic valve mounted on the delivery apparatus.

[0070] FIG.6B is a cross-sectional view of a native valve, illustrating a location of commissures of the native valve within the imaging view of FIG.6A.

[0071] FIG.7A is a perspective view of a mounting assembly comprising a support body and a ring body, according to an example.

[0072] FIG.7B is an end view of a prosthetic valve mounted on the support body of the mounting assembly of FIG.7A, with commissures aligned with corresponding indicators on the ring body.

[0073] FIG.8 is a perspective view of an exemplary positioning device mounted to a distal end portion of a delivery apparatus.

[0074] FIG.9 is a perspective view of a first side of a crimping device, which can be configured to receive the mounting assembly of FIGS 7A and 7B.

[0075] FIG.10A is a perspective view of a second side of the crimping device, which is configured to receive a flange of the positioning device of FIG.8.

[0076] FIG.10B is a side view of the crimping device of FIG.10A with the positioning device inserted into an opening of the crimping device.

[0077] FIG.10C is a side view of the crimping device of FIG.10A with the positioning device locked into engagement with complementary mating features of the crimping device.

[0078] FIG.11 is a front view of an exemplary positioning device configured to couple to a delivery apparatus and couple to a crimping device in two possible orientations, where each orientation corresponds to a different imaging view to be used during a valve implantation procedure with the delivery apparatus.

[0079] FIG.12 is a detail side view of an exemplary crimping device configured to receive and mate with the positioning device of FIG.11.

[0080] FIG.13A is a side view of the distal end portion of the delivery apparatus of FIG.2A, wherein the delivery apparatus includes a second radiopaque marker disposed on a distal shoulder of the delivery apparatus.

[0081] FIG.13B is a perspective view of the delivery apparatus of FIG.13A, showing the first radiopaque marker and the second radiopaque marker circumferentially offset from one another on the distal shoulder, and where the first radiopaque marker is a “C”.

[0082] FIG.14 is a perspective view of the delivery apparatus of FIG.13A, showing the first radiopaque marker and the second radiopaque marker circumferentially offset from one another on the distal shoulder, where the first radiopaque marker is a “3”.

[0083] FIG.15 is a side view of the delivery apparatus of FIG.12A, showing a predetermined circumferential offset between the second radiopaque marker and a selected commissure of the radially compressed prosthetic valve.

[0084] FIG.16 is a schematic of a three-cusp imaging view of a native valve and a distal end portion of a delivery apparatus at or adjacent to the native valve.

[0085] FIG.17 is a schematic of a cross-sectional view of the native valve with the distal end portion of the delivery apparatus disposed therein, for the three-cusp imaging view of FIG. 16.

[0086] FIG.18 is a schematic of a two-cusp (or cusp overlap) imaging view of a native valve and a distal end portion of a delivery apparatus at or adjacent to the native valve.

[0087] FIG.19 is a schematic of a cross-sectional view of the native valve with the distal end portion of the delivery apparatus disposed therein, for the two-cusp imaging view of FIG.18. DETAILED DESCRIPTION General Considerations

[0088] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0089] 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.

[0090] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0091] 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., out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (e.g., into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0092] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0093] Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valves can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on the delivery apparatus. The prosthetic valve can be expanded to the radially expanded state once the prosthetic valve reaches the implantation site. It is understood that the prosthetic valves disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail later.

[0094] As introduced above, it may be desirable to deploy a prosthetic valve at a native valve using a delivery apparatus such that commissures of the prosthetic valve are aligned with commissures of the native valve. Such alignment can improve the performance of the implanted prosthetic heart valve, improve the function of the native anatomy, and / or enable future interventional procedures that require access to coronary arteries or the valve leaflet. In some examples, the prosthetic valve can be mounted on a distal end portion of a delivery apparatus and the distal end portion of the delivery apparatus can include a radiopaque marker that is configured to be aligned with a guidewire and / or the native anatomy at an implantation site. For example, during an implantation procedure, a user can utilize fluoroscopy (for example, long axis fluoroscopy) to visualize the distal end portion of the delivery apparatus, including the radiopaque marker, relative to the surrounding nativeanatomy (for example, the native aortic valve) and / or a guidewire extending through the delivery apparatus in order to implant the prosthetic valve such that the target commissure is aligned with a native valve commissure. In some instances, the circumferential position of a target commissure of the prosthetic valve, when mounted on the delivery apparatus prior to the implantation procedure, relative to the radiopaque marker can be predetermined based on the fluoroscopic imaging view to be used during the implantation procedure. However, current systems and methods for mounting the prosthetic valve onto the delivery apparatus in a predetermined orientation relative to the radiopaque marker, and for deploying the prosthetic valve at the native valve, may not allow a user to select from a plurality of possible imaging views for imaging the heart and positioning the distal end portion of the delivery apparatus relative to the native valve (e.g., a three-cusp view vs. a cusp overlap view). For example, for each imaging view, the known location of a target commissure of the native valve may be different. As a result, it is desirable to have systems and methods for allowing a user to implant the prosthetic valve with commissures aligned with commissures of the native valve, using the same delivery apparatus and a desired imaging view.

[0095] FIGS.1A and 1B show an exemplary prosthetic heart valve in a radially expanded configuration that can be mounted into a radially compressed configuration onto a delivery apparatus (e.g., the delivery apparatus of FIGS.2A-2C). Instead of implanting the prosthetic valve in a random circumferential orientation relative to the native valve (as shown in FIG. 4A), it may be desirable to implant the prosthetic valve with commissures aligned with those of the native valve, thereby maintaining coronary access. In some examples, the delivery apparatus can comprise one or more radiopaque markers on a distal end portion of the delivery apparatus, as shown in FIG.2C. The marker(s) can be configured to enable positioning of the prosthetic valve mounted thereon at an implantation site such that upon deployment, the prosthetic valve is implanted with its commissures aligned with commissures of the native valve, as shown in the example of FIG.4B. In some examples, in an imaging view, the marker can be aligned with a guidewire extending through the delivery apparatus (as shown in FIG.3), and due to a predetermined amount of offset between the marker and a selected commissure of the prosthetic valve which is based on the imaging view (and a known location of a target commissure of the native valve), the prosthetic valve can be deployed such that its commissures align with the commissures of the native valve upon implantation.

[0096] Various imaging views can be used for visualization during a valve implantation procedure, such as the three-cusp view shown in FIGS.5A and 5B or the two-cusp (or cusp overlap) view shown in FIGS.6A and 6B. The location of commissures of the native valve can be different between these two imaging views, as shown in FIGS.5B and 6B. Thus, in some examples, the prosthetic valve can be mounted onto the delivery apparatus in a predetermined circumferential orientation relative to a radiopaque marker on the delivery apparatus which can be based on a specified imaging view and known arrangement of native valve commissures within the specified imaging view.

[0097] FIGS.7A and 7B show an exemplary mounting assembly that can be used to orient a prosthetic heart valve within a crimping device (such as the crimping device shown in FIG.9) at a specified circumferential orientation relative to the crimping device. FIG.8 shows an exemplary positioning device that can couple to a distal end portion of a delivery apparatus and the crimping device (e.g., the crimping device of FIGS.10A-10C, such that the radiopaque marker on the delivery apparatus is held in a predetermined circumferential orientation within the crimping device. As a result, the prosthetic valve can be crimped onto the delivery apparatus such that a selected commissure of the prosthetic valve is circumferentially offset from the radiopaque marker on the delivery apparatus by a predetermined amount. However, this predetermined amount and configuration of the delivery apparatus may only work for one imaging view.

[0098] Thus, in some examples, the crimping device and / or positioning device can be adapted such that the positioning device (as shown in FIG.11) can be coupled to the crimping device (as shown in FIG.12) in two different circumferential (or rotational orientations), thereby resulting in the prosthetic valve being crimped onto the delivery apparatus in two different rotational orientations relative to the radiopaque marker on the delivery apparatus. The two different circumferential orientations can correspond to two different imaging views to be used during an implantation procedure, which results in the prosthetic valve being implanted with commissures aligned with the native valve commissures.

[0099] In some examples, to accommodate use of the same delivery apparatus for implantation procedures utilizing different fluoroscopic imaging views, the delivery apparatus can include two radiopaque markers that are circumferentially spaced apart from one another (as shown in the examples of FIGS.13A-15). Each marker can correspond to adifferent imaging view to be used during the implantation procedure. In this way, by aligning a first marker with a guidewire in a first imaging view (as shown in FIGS.16 and 17) or aligning the second marker with the guidewire in a second imaging view (as shown in FIGS. 18 and 19), the same delivery apparatus can be used to implant the prosthetic valve with commissures in alignment with those of the native valve.

[0100] In this way, the delivery apparatus and / or components for mounting a prosthetic valve onto a delivery apparatus can be adapted such that the same delivery apparatus can be used to achieve commissure alignment in different implantation procedures utilizing different imaging views. Examples of the Disclosed Technology

[0101] FIGS.1A and 1B show an exemplary prosthetic valve 50. Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in other examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries and vessels of a patient. The disclosed prosthetic 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.

[0102] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, in one example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No.2017 / 0231756, which is incorporated by reference herein. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspidvalve, such as disclosed in U.S. Publication No.2019 / 0000615, which is incorporated herein by reference.

[0103] The prosthetic valve 50 can have three main components: a stent or frame, 52, a valvular structure 54, and a sealing member 56 (FIG.1A). FIG.1B is a perspective view of the prosthetic valve 50 with the components on the outside of the frame 52 (including the sealing member 56) shown in transparent lines for purposes of illustration. The prosthetic valve 50 can have an inflow end 66 and an outflow end 68.

[0104] The valvular structure 54 can comprise three leaflets 60, 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 60). In some examples, the leaflets 60 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, which is incorporated by reference herein.

[0105] Each leaflet 60 can be coupled to the frame 52 along its inflow edge 62 (the lower edge in the figures; also referred to as “cusp edges”) and at commissures 64 of the valvular structure 54 where adjacent portions (e.g., commissure tabs) of two leaflets are connected to each other. In some examples, the commissures 64 can comprise an attachment member (e.g., comprising fabric, flexible polymer, or the like) arranged across a cell (e.g., commissure cell) of the frame 52, the cell formed by struts of the frame. The attachment member can be secured to the struts of the frame forming the cell and the adjacent portions of the two leaflets can be connected to the attachment member to form the commissure 64 (e.g., as shown in FIGS.3-8, as described further below).

[0106] 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 struts of the frame to couple the cusp edges of the leaflets to the frame.

[0107] The frame 52 can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., Nitinol). When constructed of a plastically-expandable material, the frame 52 (and thus the prosthetic valve 50) can be crimped to a radially collapsed configuration on a delivery apparatus (e.g., catheter) and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. Various crimping devices can be used to crimp the prosthetic valve 50 and the otherprosthetic 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.

[0108] In some instances, the prosthetic valve 50 can be crimped directly onto the inflatable balloon of the delivery apparatus, such that the prosthetic valve 50 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 50 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.

[0109] When constructed of a self-expandable material, the frame 52 (and thus the prosthetic valve 50) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery apparatus. 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.

[0110] Suitable plastically-expandable materials that can be used to form the frame 52 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 52 can comprise stainless steel. In some examples, the frame 52 can comprise cobalt-chromium. In some examples, the frame 52 can comprise nickel-cobalt-chromium. In some examples, the frame^52 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.

[0111] The frame 52 in the illustrated example comprises a plurality of circumferentially extending rows of angled struts 72 defining rows of open cells 74 (or openings) of the frame. The frame 52 can have a cylindrical or substantially cylindrical shape having a constant diameter from the inflow end 66 to the outflow end 68 of the frame 52 as shown, or the frame 52 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.

[0112] The frame 52, at each of the inflow end 66 and the outflow end 68, may comprise a plurality of apices 80 spaced apart from one another around a circumference of the frame 52.

[0113] The sealing member 56 in the illustrated example is mounted on the outside of the frame 52 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 56 can comprise an inner layer 76 (which can be in contact with the outer surface of the frame 52) and an outer layer 78. The sealing member 56 can be connected to the frame 52 using suitable techniques or mechanisms. For example, the sealing member 56 can be sutured to the frame 52 via sutures that can extend around the struts 72 and through the inner layer 76. In alternative examples, the inner layer 76 can be mounted on the inner surface of the frame 52, while the outer layer 78 is on the outside of the frame 52.

[0114] The outer layer 78 can be configured or shaped to extend radially outward from the inner layer 76 and the frame 52 when the prosthetic valve 50 is deployed. When the prosthetic valve is fully expanded outside of a patient’s body, the outer layer 78 can expand away from the inner layer 76 to create a space between the two layers. Thus, when implanted inside the body, this allows the outer layer 78 to expand into contact with the surrounding tissue.

[0115] Additional details regarding the prosthetic valve 50 and its various components are described in U.S. Patent Publication No.2018 / 0028310, which is incorporated herein by reference.

[0116] FIG.2A shows an exemplary delivery apparatus 100, which can be used to implant an expandable prosthetic heart valve (for example, the prosthetic valve 50 of FIG.1A), or another type of expandable prosthetic medical device (such as a stent). A distal end portion 109 of the delivery apparatus 100 is shown in FIGS.2B and 2C (cross-sectional side view and side view, respectively). In some examples, the delivery apparatus 100 is specifically adapted for use in introducing a prosthetic valve into a heart. As described further below, the delivery apparatus 100 can be configured to rotate the prosthetic valve, mounted on the delivery apparatus in a radially compressed state, at the target implantation site (for example, at a native valve of the heart) to achieve commissure alignment between the native valve and prosthetic valve after deploying the prosthetic valve.

[0117] In the depicted example, the delivery apparatus 100 is a balloon catheter comprising a handle 102 and a steerable, outer shaft 104 extending distally from the handle 102. Thedelivery apparatus 100 can further comprise an intermediate shaft 106 (which also may be referred to as a balloon shaft) that extends both proximally and distally from the handle 102. The portion of the intermediate shaft 106 extending distally from the handle 102 also extends coaxially through the outer shaft 104. Additionally, the delivery apparatus 100 can further comprise an inner shaft 108 extending distally from the handle 102 and coaxially through the intermediate shaft 106 and the outer shaft 104. The inner shaft 108 also extends proximally from the handle 102 and coaxially through the intermediate shaft 106.

[0118] The outer shaft 104 and the intermediate shaft 106 are configured to translate longitudinally, along a central longitudinal axis 120 of the delivery apparatus 100, relative to one another to facilitate delivery and positioning of a prosthetic valve at an implantation site in a patient’s body.

[0119] The intermediate shaft 106 can include a proximal end portion 110 that extends proximally from a proximal end of the handle 102, to an adaptor 112. A rotatable knob 114 can be mounted on the proximal end portion 110. The knob 114 can be configured to rotate the intermediate shaft 106 around the central longitudinal axis 120 of the delivery apparatus 100 and relative to the outer shaft 104.

[0120] The adaptor 112 can include a first port 138 configured to receive a guidewire therethrough and a second port 140 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 140 can be fluidly coupled to an inner lumen of the intermediate shaft 106.

[0121] The intermediate shaft 106 can further include a distal end portion 116 that extends distally beyond a distal end of the outer shaft 104 when the distal end of the outer shaft 104 is positioned away from an inflatable balloon 118 of the delivery apparatus. A distal end portion of the inner shaft 108 can extend distally beyond the distal end portion 116 of the intermediate shaft 106.

[0122] The balloon 118 can be coupled to the distal end portion 116 of the intermediate shaft 106. For example, a proximal end portion of the balloon 118 can be coupled to and / or around a distal end 148 of the intermediate shaft 106.

[0123] The balloon 118 can comprise a distal end portion (or section) 132, a proximal end portion (or section) 133, and an intermediate portion (or section) 135, the intermediate portion 135 disposed between the distal end portion 132 and the proximal end portion 133.

[0124] In some examples, a distal end of the distal end portion 132 of the balloon 118 can be coupled to a distal end of the delivery apparatus 100, such as to a nose cone 122, or to an alternate component at the distal end of the delivery apparatus 100 (for example, a distal shoulder). In some examples, the intermediate portion 135 of the balloon 118 can overlay a valve mounting portion 124 of a distal end portion 109 of the delivery apparatus 100, the distal end portion 132 can overly a distal shoulder 126 of the delivery apparatus 100, and the proximal end portion 133 can surround a portion of the inner shaft 108 (FIG.2B). The valve mounting portion 124 and the intermediate portion 135 of the balloon 118 can be configured to receive a prosthetic valve in a radially compressed state.

[0125] As described herein, rotation of the intermediate shaft 106 can cause rotation of the balloon 118 and the prosthetic valve mounted thereon for rotational positioning of the prosthetic valve relative to the native anatomy at the target implantation site.

[0126] The delivery apparatus 100 can include a balloon shoulder assembly 180 configured to maintain the prosthetic heart valve or other medical device at a fixed position on the balloon 118 during delivery through the patient’s vasculature. The balloon shoulder assembly 180 can include a distal shoulder 126 arranged within a distal end portion of the balloon 118 and coupled to the distal end portion of the inner shaft 108. The distal shoulder 126 can be configured to resist movement of the prosthetic valve or other medical device mounted on the valve mounting portion 124 distally, in an axial direction (for example, along the central longitudinal axis 120), relative to the balloon 118.

[0127] For example, the distal shoulder 126 can include a flared portion 131 arranged adjacent to the valve mounting portion 124 (as shown in FIGS.2B and 2C). In some examples, the flared portion 131 can include a plurality of wings 130 that flare radially outward from a base portion 125 (for example, shaft) of the distal shoulder 126, toward the valve mounting portion 124. In some examples, the flared portion 131 can comprise four wings 130 spaced circumferentially apart from one another.

[0128] The outer shaft 104 can include a distal tip portion 128 mounted on its distal end. In some examples, the distal tip portion 128 can be configured as a flex adaptor including a plurality of inner and outer helical grooves. The outer shaft 104 and the intermediate shaft 106 can be translated axially relative to one another to position the distal tip portion 128 adjacent to a proximal end of the valve mounting portion 124, when a prosthetic valve is mounted in the radially compressed state on the valve mounting portion 124 and duringdelivery of the prosthetic valve to the target implantation site. As such, the distal tip portion 128 can be configured to resist movement of the prosthetic valve relative to the balloon 118 proximally, in the axial direction, relative to the balloon 118, when the distal tip portion 128 is arranged adjacent to a proximal side of the valve mounting portion 124.

[0129] In some examples, the nose cone 122 can be disposed distal to and be coupled to the distal shoulder 126. In some examples, the nose cone 122 can be coupled to the distal end portion of the inner shaft 108.

[0130] In some examples, the delivery apparatus 100 can comprise one or more markers or marker bands 153 that are configured to indicate to a user a location of a specified component of the delivery apparatus. In some examples, the one or more marker bands 153 can be radiopaque. In some examples, one or more marker bands 153 can be radially compressed (for example, crimped), or otherwise mounted, onto the inner shaft 108.

[0131] An annular space 136 can be defined between an outer surface of the inner shaft 108 and an inner surface of the intermediate shaft 106. In some examples, the annular space 136 can be referred to as an inner lumen of the intermediate shaft 106. In some examples, the annular space 136 can be configured to receive an inflation fluid from a fluid source via the second port 140 of the adaptor 112 (for example, the annular space 136 can be in fluid communication with the second port 140 of the adaptor 112). The annular space 136 can be fluidly coupled to a fluid passageway 142 formed between the outer surface of the distal end portion of the inner shaft 108 and an inner surface of the balloon 118. As such, fluid from the fluid source can flow to the fluid passageway 142 from the annular space 136 to inflate the balloon 118 and radially expand and deploy the prosthetic valve.

[0132] In some examples, the distal end portion 132 of the balloon 118 can include a radial depression 134 that is depressed radially inwardly, toward the central longitudinal axis 120, relative to an outermost radial surface of the distal shoulder 126 and an outermost radial surface of the nose cone 122. In some examples, after crimping of the prosthetic valve onto the valve mounting portion 124, the distal tip portion 128 can be advanced over the proximal end portion 133 of the balloon 118. As a result, fluid arranged within the proximal end portion 133 of the balloon 118 can be displaced and pushed distally, within the balloon 118, to the distal end portion 132 of the balloon 118. The radially depressed, distal end portion 132 of the balloon 118 can then radially expand (for example, inflate partially) as it receives the displaced fluid to an expanded state. The radial depression 134 can be configured (forexample, sized) so that the distal end portion 132 can receive the displaced fluid without radial expanding the portion of the balloon 118 within the valve mounting portion 124, thereby preventing the crimped profile of the prosthetic valve from increasing.

[0133] In some examples, the distal end portion 132 of the balloon 118 may not include the radial depression 134. In some examples, the proximal end portion 133 of the balloon may not have an outwardly formed shape (as shown in FIG.2B), and instead may have a more cylindrical cross-section, as shown in FIG.2C. In such examples, the distal end portion 132 may not need the radial depression 134 since there will be little to no excess fluid that gets displaced from the proximal end portion 133 as the distal tip portion 128 is advanced over the more cylindrical proximal end portion 133.

[0134] An inner lumen 144 of the inner shaft 108 can be configured to receive a guidewire therethrough, for navigating the distal end portion 109 of the delivery apparatus 100 to the target implantation site. As introduced above, the first port 138 of the adaptor 112 can be coupled to the inner lumen 144 and configured to receive the guidewire. For example, the distal end portion 109 of the delivery apparatus 100 can be advanced over the guidewire, to the target implantation site.

[0135] As shown in FIG.2A, the handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion 109 of the delivery apparatus 100. For example, the handle 102 can include an adjustment member, such as the illustrated rotatable knob 160, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 102 through the outer shaft 104 and has a distal end portion affixed to the outer shaft 104 at or near the distal end of the outer shaft 104. Rotating the knob 160 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion 109 of the delivery apparatus 100. Further details on steering or flex mechanisms for the delivery apparatus are described in U.S. Patent No. 9,339,384, which is incorporated by reference herein in its entirety.

[0136] The handle 102 can further include an adjustment mechanism 161 including an adjustment member, such as the illustrated rotatable knob 162. The adjustment mechanism 161 can be configured to move (thus adjust the axial position) of the intermediate shaft 106 relative to the outer shaft 104. The handle 102 can also include a locking mechanism configured to retain (for example, lock) the position of the intermediate shaft 106 relative to the handle 102. In some examples, the locking mechanism can include another adjustmentmember, which can be configured as a rotatable knob 178. In some examples, rotating the knob 178 to a locked position can cause the intermediate shaft 106 to frictionally engage with other components of the handle 102, thereby restraining movement of the intermediate shaft 106 for fine positioning of the prosthetic valve mounted on the distal end portion of the delivery apparatus 100. Rotating the knob 178 to an unlocked position allows axial and rotational movement of the intermediate shaft 106 relative to the proximal end portion of the handle 102. For example, rotation of the knob 162 can cause the intermediate shaft 106 to move axially relative to the outer shaft 104 (either in the proximal or distal direction, depending on the direction the knob 162 is rotated).

[0137] Further details on the adjustment mechanism and locking mechanism of the handle 102 can be found in U.S. Patent No.9,339,384, which is incorporated by reference herein in its entirety. Additional examples of delivery apparatuses and related steering mechanism can be found in U.S. Patent No.8,568,472, which is incorporated herein by reference in its entirety.

[0138] According to certain examples, to implant a prosthetic valve (for example, prosthetic valve 50) in a native heart valve of the patient, the delivery apparatus 100 can be introduced into vasculature of the patient. The prosthetic valve can be initially retained in a radially compressed configuration on the valve mounting portion 124 (and over the balloon 118) of the delivery apparatus 100.

[0139] In some instances, once inside the patient’s vasculature, the position (e.g., axial position) of the prosthetic valve relative to the balloon 118 can be adjusted such that the prosthetic valve 50 is centered on the balloon 118. In some instances, the axial position of the prosthetic valve relative to the balloon 118 may not be adjusted.

[0140] When navigating the prosthetic valve through an arched region of the vasculature (for example, the aortic arch), the curvature of the distal end portion 109 of the delivery apparatus 100 can be adjusted, for example, by rotating the knob 160 to increase or decrease the tension in the pull wire which extends between the handle 102 and the distal end of the outer shaft 104. The prosthetic valve can be positioned within or adjacent an annulus of the native heart valve. Prior to inflating the balloon 118, the outer shaft 104 can be retracted proximally away from the balloon 118 for a sufficient distance so that the outer shaft does not interfere with balloon inflation. This can be accomplished, for example, by holding the adaptor 112 stationary against the operating table and rotating the knob 162 in a direction that causes thehandle 102 and the outer shaft 104 to move proximally away from the balloon 118. Then, the prosthetic valve can be radially expanded and deployed by inflating the balloon 118. Inflation of the balloon 118 can radially expand the prosthetic valve 50 so that the prosthetic valve 50 contacts the native annulus. The expanded prosthetic valve 50 becomes anchored within the native aortic annulus by the radial outward force of the valve’s frame against the surrounding tissue.

[0141] As described above, the knob 114 of the handle 102 can be configured to rotate the intermediate shaft 106, thereby rotating the balloon 118 mounted on the intermediate shaft 106, a radially compressed prosthetic valve mounted on the balloon 118, around the valve mounting portion 124, and the inner shaft 108. Thus, rotating the knob 114 can rotate the prosthetic valve, around the central longitudinal axis 120, into a desired (circumferential or rotational) orientation relative to the native anatomy at the target implantation site.

[0142] For example, to implant a prosthetic valve (for example, prosthetic valve 50) at a native aortic valve, instead of deploying the prosthetic valve with the delivery apparatus 100 in a random rotational orientation relative to the aorta 205, which may result in commissures (for example, commissures 64) of the prosthetic valve being arranged in front of the coronary arteries 204 (as shown in the example of FIG.4A), it may be desirable to deploy the prosthetic valve in a targeted rotational orientation where the commissures 64 are positioned away from and do not block the coronary arteries 204 (e.g., to reduce the likelihood of blocking coronary access during subsequent interventional procedures). Specifically, the delivery apparatus 100 can be configured to control the rotational positioning of the prosthetic heart valve 50 relative to the native valve 202, to achieve the commissure alignment shown in the example of FIG.4B, thereby increasing access to the coronary arteries 204. For example, as shown in FIG.4B, the prosthetic valve 50 is implanted such that its commissures 64 are circumferentially aligned with the commissures 212 of the native aortic valve. Additionally, this positioning of the prosthetic heart valve can facilitate a later, leaflet cutting procedure that provides increased access to the coronary arteries.

[0143] To facilitate implanting a prosthetic valve such that its commissures are circumferentially aligned with commissures of the native valve, the delivery apparatus 100 can comprise at least one radiopaque marker 150 disposed on the distal end portion 109 of the delivery apparatus 100, as shown in FIG.2C. For example, the at least one radiopaquemarker 150 can be disposed on the distal end portion 109 of the delivery apparatus 100, adjacent to the valve mounting portion 124.

[0144] The radiopaque marker 150 is configured to be visible under medical imaging. For example, the marker(s) can comprise a radiopaque material that is configured to be visible under medical imaging, such as fluoroscopy and / or other types of X-ray imaging. In some examples, the marker(s) can comprise a radiopaque or other material that is configured to be visible under MRI, ultrasound, and / or echocardiogram. In some examples, the markers described herein can comprise tantalum. In some examples, the markers described herein can comprise another type of radiopaque material or combination of materials, such as one or more of iodine, barium, barium sulfate, tantalum, bismuth, or gold.

[0145] As shown in FIG.2C, the marker 150 is arranged on and / or embedded within a portion of the distal shoulder 126. In some examples, as shown in FIG.2C, the marker 150 is arranged on and / or embedded in one of the wings 130 of the flared portion 131 of the distal shoulder 126. As a result, the marker 150 is oriented radially outward from an outer surface of the inner shaft 108. Further, when the radially compressed prosthetic valve is arranged on the valve mounting portion 124, the marker 150 can be arranged proximate and adjacent to the prosthetic valve.

[0146] In some examples, the marker 150 can be centered on one of the wings 130, such that it is centered along the central longitudinal axis 120.

[0147] In some examples, instead of being arranged on or in a wing 130 of the distal shoulder 126, the marker 150 can be arranged on and / or embedded within another portion of the distal shoulder 126 or another polymeric body or component of the distal end portion 109 of the delivery apparatus 100. For example, in some examples, the marker 150 can be positioned on and / or embedded within the nose cone 122.

[0148] The marker 150 can have various shapes or patterns. For example, though the marker 150 is shown in FIG.2C as having a C shape, in some examples, the marker 150 can be configured as a different asymmetric shape or symbol, such as a star, triangle, “X”, “2”, “3”, or the like. Additional examples of the shape of the marker, and multiple differently shaped markers for the delivery apparatus are described below with reference to FIGS.13A-15.

[0149] For example, the asymmetric marker 150 can be reflection asymmetric along an axis that is parallel to the central longitudinal axis of the delivery apparatus. In this way, under medical imaging, such as fluoroscopy, a position of the marker 150 within the imaging view,relative to the guidewire (e.g., a front vs. a back of the imaging view), can be more easily discerned, as described further below.

[0150] Arranging the marker 150 on or in the distal shoulder 126, or another polymeric body of the distal end portion of the delivery apparatus 100, can allow the marker 150 to be more visible under imaging, such as fluoroscopy, since a remainder of the distal shoulder 126 can be less or non-radiopaque, and thus, can be less, or not, visible in the fluoroscopic image.

[0151] As shown in the exemplary fluoroscopic image or imaging view 152 of FIG.3, a guidewire 154 extending through a center of the distal end portion 109 of the delivery apparatus 100 (e.g., through the inner lumen of the inner shaft 108) is visible under fluoroscopy. The marker 150 can be positioned radially outward of the guidewire 154 due to the marker 150 being positioned on the flared portion 131 of the distal shoulder 126, as described above. This further increases the visibility of the marker 150 under imaging, during an implantation procedure. When the marker 150 is arranged in a direct back or direct front of the imaging view, the marker 150 can appear to overlap the guidewire 154. For example, as shown in FIG.3, the C-shaped asymmetric marker 150 is aligned with (e.g., overlapping) the guidewire 154 and the “C” is readable, in its first (forward) orientation. In some examples, this position of the marker 150 shown in FIG.3 may indicate the marker 150 is arranged behind the guidewire 154 within the fluoroscopic imaging view 152, and thus, in the direct back of the imaging view.

[0152] Arranging the marker 150 on or in the distal shoulder 126 (or another polymeric body of the delivery apparatus that is positioned offset from the prosthetic valve, in the axial direction) also allows the marker 150 to be offset, in a circumferential direction, from a selected commissure of the prosthetic valve (when mounted on the delivery apparatus). For example, since, in some examples, the prosthetic valve rotates upon inflation of the inflatable balloon 118, the marker 150 can be offset in the circumferential direction from the selected commissure of the prosthetic valve mounted on the delivery apparatus to compensate for this rotation. As a result, after deployment of the prosthetic valve, the selected commissure of the prosthetic valve may be aligned with the target commissure of the native valve.

[0153] During an implantation procedure, a selected imaging view (e.g., fluoroscopic imaging view) can be used to visualize the distal end portion of the delivery apparatus, including the marker 150 and the radially compressed prosthetic valve (e.g., frame 52) relative to the surrounding native anatomy. For example, FIG.5A shows a schematic of afirst imaging view, known as a three-cusp imaging view 250. In the three-cusp imaging view 250, the non-coronary cusp 252 of the native valve (e.g., aortic valve) 260 and the left coronary cusp 254 are arranged opposite one another in the view and each are overlapped by a different portion of the right coronary cusp 256, with all three cusps aligned along a transverse axis 258. Thus, as shown in the cross-sectional view of the native valve 260 in FIG.5B, for the three-cusp imaging view 250, a selected commissure 262 of the native valve 260, which is arranged between the non-coronary cusp 252 and the left coronary cusp 254 is arranged in the direct back 264 of the three-cusp imaging view 250. FIG.5B also shows the direct front 266 of the imaging view, in which the right coronary cusp 256 is located.

[0154] FIG.6A shows a schematic of a second imaging view that can be used by a medical professional during an implantation procedure, known as a cusp overlap view 270 (which can also be referred to as a two-cusp imaging view). In some examples, the cusp overlap view 270 can also be referred to as a two-cusp view. In some examples, in the cusp overlap view 270, the left coronary cusp 254 and the right coronary cusp 256 overlap one another and the non-coronary cusp 252 is offset from the left coronary cusp 254 and the right coronary cusp 256 (and thus can be referred to as a right / left cusp overlap view). As shown in the cross- sectional view of the native valve 260 in FIG.6B, for the cusp overlap view 270, the selected commissure 262 is circumferentially offset from the direct back 264 of the imaging view.

[0155] In some examples, in the cusp overlap view 270, the right coronary cusp 256 and the non-coronary cusp 252 overlap one another and the left coronary cusp 254 is offset from the right coronary cusp 256 and the non-coronary cusp 252. As such, the selected commissure 262 would be offset from the direct back 264 of the imaging view.

[0156] It should be noted that, in some examples, a different commissure of the native valve (other than the commissure arranged between the non-coronary cusp and the left coronary cusp) can be the selected commissure on which the predetermined offset between the marker and the selected commissure of the prosthetic valve is at least partially based.

[0157] In this way, based on an existing knowledge of a location of a selected commissure (or commissures) of the native valve (in which the prosthetic valve is to be implanted) within the selected imaging view, a user can rotationally align the distal end portion of the delivery apparatus at the target implantation site, such that the marker 150 is aligned with the known location of the selected commissure, in the selected imaging view, or such that the marker 150 is arranged in a certain position within the selected imaging view (e.g., direct back) anddeploying the prosthetic valve in such an orientation will result in commissure alignment between the prosthetic valve and the native valve.

[0158] Further details on the delivery apparatus 100 and systems and methods for aligning commissures of a prosthetic valve with commissure of a native valve are described in PCT Patent Publication No. WO 2022 / 046585, which is incorporated by reference herein in its entirety.

[0159] In some examples, one or more radiopaque markers on the distal end portion of the delivery apparatus can be configured to indicate a circumferential location of a selected commissure of the prosthetic valve after radially expanding the prosthetic valve with the delivery apparatus (for example, via inflating a balloon of the delivery apparatus). In some examples, one or more radiopaque markers on the distal end portion of the delivery apparatus can be configured to be aligned with a guidewire in an imaging view, thereby resulting in commissure alignment between the prosthetic valve and native valve upon deployment of the prosthetic valve with the delivery apparatus. For example, as described further below with reference to FIGS.7A-9, the prosthetic valve can be mounted onto the valve mounting portion of the delivery apparatus such that a selected commissure is circumferentially offset from a corresponding radiopaque marker on the delivery apparatus by a specified amount. The offset can account for rotation of the prosthetic valve during valve deployment (e.g., during balloon inflation) and / or the imaging view being used for visualization and alignment during the implantation procedure, such that the selected commissure of the prosthetic valve is aligned with the target commissure of the native valve after deployment.

[0160] For crimping a prosthetic valve onto a valve mounting portion of a delivery apparatus, in a specified circumferential (or rotational) orientation and / or axial orientation (or position), a mounting assembly can be used. The mounting assembly can comprise a support body (which can also be referred to as a coupling and support member) and an alignment ring (which can also be referred to as a ring body). A first portion of the support body can be configured to receive the prosthetic valve (e.g., prosthetic valve 50) thereon and a second portion of the support body can couple to a crimping device (e.g., crimping device 500 shown in FIGS.9-10C). The alignment ring coupled with the support body can be configured to rotationally (or circumferentially) align the prosthetic valve on the first portion of the support body and couple with the crimping device such that the prosthetic valve is held within the crimping device in a specified circumferential orientation and / or axial orientation relative tothe crimping device. As a result, the prosthetic valve can be crimped into a radially compressed configuration onto a valve mounting portion of a delivery apparatus (e.g., delivery apparatus 100) such that the radially compressed prosthetic valve is in a specified circumferential orientation and / or axial orientation relative to the delivery apparatus (e.g., such that a specified commissure of the radially compressed prosthetic valve is circumferentially offset from a corresponding radiopaque marker on the delivery apparatus by a predetermined amount).

[0161] Further, in some examples, it may be desirable to maintain the leaflets (for example, leaflets 60 of prosthetic valve 50) in an open position during crimping of the prosthetic valve to the delivery apparatus, thereby reducing a likelihood of degradation to the leaflets and / or attachments of the leaflets to a frame of the prosthetic valve. Thus, in some examples, the first portion (a valve support portion) of the support body can be configured to support and / or maintain one or more leaflets of the prosthetic valve in an open position within the crimping device and during crimping.

[0162] FIGS.7A and 7B depict an exemplary mounting assembly 300 which comprises a support body 301 and a ring body 306 (which can also be referred to herein as an alignment ring). The support body 301 can be configured to be inserted into a crimping device, such as the crimping device 500 shown in FIG.9, and can have a coupling portion 302 and a support portion 304 configured to be positioned between one or more leaflets of the prosthetic device and the delivery apparatus (e.g., delivery apparatus 100) and for supporting the one or more leaflets in an open position when the prosthetic valve is mounted thereon (as shown in FIG. 7B). The coupling portion 302 is configured to be received within and / or couple to the crimping device. The support portion 304 can include an outward-facing support surface 310 that is configured to receive the prosthetic valve thereon (and interface with the valve leaflets).

[0163] In some examples, as shown in FIG.7A, the coupling portion 302 can have a cylindrical shape with a cylindrical outer surface 312. An alignment member 324 can be arranged on the coupling portion 302 and configured to rotationally align the support body 301 with the crimping device. The alignment member 324 can be circumferentially positioned on the coupling portion 302, proximate to a first end 303 of the coupling portion 302 (and support body 301), at a position that circumferentially aligns the support body 301 in a predetermined position and orientation within the crimping device.

[0164] An exemplary crimping device 500 (which can also be referred to as a crimper), which can be configured to receive the mounting assembly 300, is shown in FIGS.9-10C. FIG.9 illustrates a front perspective view of the crimping device 500 (or a view from the distal side of the crimping device 500) and FIGS.10A-10C illustrate rear views of the crimping device 500 (or views from the proximal side of the crimping device 500). The crimping device 500 can include a base 586, an actuator in the form of a handle 588, and a channel 590 for the prosthetic valve and the delivery apparatus to be inserted into.

[0165] The crimping device 500 can further include a rotatable body 598 configured to be rotated with rotation of the handle 588. The crimping device 500 can operate by a plurality of pressing surfaces 584 surrounding the channel 590 and being configured to apply a compressive force to radially compress a prosthetic valve positioned within the channel 590 (for example, prosthetic valve 50). The pressing surfaces 584 may surround an axis 502 of the channel 590. The pressing surfaces 584 may be configured such that as the rotatable body 598 is rotated, a body presses and moves the pressing surfaces 584 towards the center of the channel 590 and the diameter of the channel 590 reduces. A prosthetic valve positioned within the channel 590 will accordingly be compressed within the channel 590, due to the radially compressive force of the pressing surfaces 584 against the prosthetic valve.

[0166] The crimping device 500 may include a proximal face 592 including a proximal opening 594 that leads into the channel 590 (as shown in FIG.10A). The proximal opening 594 may be configured for the delivery apparatus (e.g., the delivery apparatus 100) to be inserted into the channel 590 therethrough.

[0167] In some examples, the proximal face 592 can include a mating interface with mating structures, configured as slots 596 that are shaped to receive complementary features of a positioning device (for example, the extension portions 406 of the positioning device 400 shown in FIG.8, as described further below and described in more detail in PCT Patent Publication No. WO 2022 / 046585, which is already incorporated by reference above). The crimping device 500 includes three circumferentially spaced apart slots 596, where each slot 596 is configured to receive a respective extension portion of the positioning device. Additional details on the mating interface between the slots 596 and positioning device will be described further below.

[0168] As shown in FIG.9, the crimping device 500 can include a distal face 504 including a distal opening 506 that leads into the channel 590. The distal face 504 can include a matinginterface, which can comprise a cut-out 508. In some examples, the cut-out 508 can be configured as (and referred to as) a recess, channel, depression, or the like, in the distal face 504. The cut-out 508 can be shaped to receive the alignment member 324 of the support body 301.

[0169] Returning to FIG.7A, the alignment member 324 can comprise an axially extending protrusion that extends axially outward from the first end 303 toward to the support portion 304 of the support body 301. The alignment member 324 can be configured to insert into the cut-out 508 (or recess) on the distal face 504 of the crimping device 500 to rotationally align the support body 301 with the crimping device 500. The alignment member 324 can, in some examples, be further configured to allow the support body 301 to slide distally out of the cut- out 508 during operation of the crimping device 500.

[0170] The support portion 304, and thus the support surface 310, can have a tapered shape that tapers radially inward in a direction away from the coupling portion 302 toward the second end 342 of the support body 301. In some examples, the support portion 304 can have a conical shape, as shown in FIG.7A.

[0171] The support body 301 can include a central channel 344. The central channel 344 may be configured for the delivery apparatus to extend therethrough.

[0172] In operation, the prosthetic valve 50 (or another prosthetic valve) may be slid distally onto the support surface 310 of the support portion 304 of the support body 301, with the frame 52 of the prosthetic valve 50 extending over the support surface 310 and the inner surfaces of the leaflets 60 of the prosthetic valve being arranged against the support surface 310 (as shown in FIG.7B).

[0173] To align the prosthetic valve 50 in a desired circumferential orientation around the support portion 304, and to space the prosthetic valve 50 from the coupling portion 302 at a desired spacing, a ring body 306 (which can also be referred to as an alignment ring) can be utilized and positioned upon the support body 301, as shown in FIGS.7A and 7B.

[0174] The ring body 306 couples to and extends around the support body 301. In some examples, the ring body 306 can include one or more arms (which can also be referred to as body portions) 362, 364, each having an arcuate shape that forms half of the ring body 306.

[0175] A first lever (e.g., radial extension) 376 may extend radially outward from the first arm 362, and a second lever (e.g., radial extension) 378 may extend radially outward from the second arm 364. The first lever 376 and second lever 378 may each be configured to bepressed to rotate the first arm 362 or the second arm 364 about the pivot 370 to cause the ring body 306 to move to an open position (for removing the ring body 306 from the support body 301, for example).

[0176] The ring body 306 includes an alignment guide which comprises one or more indicators 360a‒c (which may also be referred to as alignment markers) configured to indicate a desired circumferential (e.g., rotational) position of selected elements (e.g., commissures) of the prosthetic valve 50 relative to the ring body 306. Each indicator 360a‒c may further indicate the desired circumferential position of the selected elements of the prosthetic valve 50 relative to the support body 301 (e.g., when the ring body 306 is coupled to the support body 301.

[0177] Each indicator 360a‒c can comprise a marking, groove, raised element, or other form of indicator. The indicators 360a‒c can be circumferentially spaced apart from each other on the ring body 306 and the circumferential position of each indicator 360a‒c can correspond to and indicate a desired position of one of the commissures of the prosthetic valve when the ring body 306 is coupled to the support body 301 and the prosthetic valve is arranged around the support portion 304 of the support body 301 (as shown in FIG.7B). As such, a user may position the ring body 306 on the support body 301 and align the commissures 64a-c of the prosthetic valve 50 with respective indicators 360a‒c (FIG.50).

[0178] In some examples, instead of being a separate component, the ring body or a similar alignment guide can be incorporated into the support body, as described in U.S. provisional application no.63 / 533,555, filed August 18, 2023, which is incorporated by reference herein in its entirety.

[0179] As a result, the prosthetic valve 50 can be crimped or radially compressed onto the delivery apparatus at a predetermined circumferential orientation relative to the delivery apparatus (e.g., relative to a radiopaque marker on the delivery apparatus, as described herein).

[0180] The mounting assembly 300 may be part of an assembly or system (e.g., mounting system) for use in crimping a prosthetic valve having one or more leaflets to a delivery apparatus. In some examples, the assemblies or systems may include a positioning device 400 configured to couple to a portion (e.g., distal end portion) of the delivery apparatus, proximal to the valve mounting portion.

[0181] FIG.8, for example, illustrates an exemplary positioning device 400 coupled to a distal end portion 109 of the delivery apparatus 100, adjacent to the valve mounting portion 124. The positioning device 400 can include a body 402 which includes a central channel that is configured to receive the intermediate shaft 106 (or another shaft portion, such as the outer shaft 104) of the delivery apparatus 100.

[0182] The positioning device 400 includes a flange 404 extending radially outward from the body 402 at a distal end of the positioning device 400. The flange 404 can include one or more mating elements that are configured to mate with correspondingly shaped mating features in a side surface (e.g., proximal face) of a crimping device (e.g., the slots 596 of the crimping device 500, as shown in FIG.10A). In some examples, as shown in FIG.8, the mating elements are configured as circumferentially extending extension portions 406 which are spaced apart from one another around a circumference (or perimeter) of the flange 404. For example, each extension portion 406 can extend circumferentially along a portion of a perimeter of the flange 404.

[0183] In some examples, the flange 404 can include an indicating element 408 that can indicate an orientation of insertion of the extension portions 406 into the crimping device 500. For example, FIGS.10A-10C show a plurality of circumferentially spaced apart slots 596 that are each configured to receive a respective extension portion 406 of the plurality of extension portions 406 of the positioning device 400.

[0184] As shown in FIGS.10A-10B, the proximal face 592 of the crimping device 500 has a first indicator 570 (e.g., a “1”) and a second indicator 572 (e.g., a “2”) which visually depict to a user how to insert and lock the flange 404 of the positioning device 400 into the crimping device such that the delivery apparatus (particularly, the radiopaque marker 150) is held within the crimping device in a predetermined circumferential orientation.

[0185] For example, during use, a user can insert the flange 404 into the proximal opening 594 including the slots 596 such that the indicating element 408 (which, in some examples can be an arrow, as shown in FIGS.8, 10B, and 10C) is circumferentially or rotationally aligned with the first indicator 570 (e.g., the “1”). The user can then rotate the flange 404 (and thus the rest of the positioning device 400 and the delivery apparatus) until the indicating element 408 reaches the second indicator 572, thereby locking the extension portions 406 into the respective slots 596 and holding the delivery apparatus within thechannel of the crimping device 500 at a predetermined circumferential orientation relative to the crimping device 500.

[0186] When both the positioning device 400 (coupled to the delivery apparatus) and the mounting assembly 300 (coupled to the prosthetic valve) are coupled to the crimping device 500, as described above, the prosthetic valve can be crimped to the delivery apparatus such that a selected commissure is circumferentially offset from a corresponding radiopaque marker on the delivery apparatus (e.g., marker 150) by a predetermined amount that will result in commissure alignment upon deployment at a native valve using a specified imaging view.

[0187] Further details on mounting assemblies, positioning devices, and systems for crimping a prosthetic valve onto a delivery apparatus such that a selected commissure of the prosthetic valve is circumferentially offset from a radiopaque marker on the delivery apparatus by a predetermined amount are described in PCT Patent Publication No. WO 2022 / 046585, which is already incorporated by reference above.

[0188] As introduced above, the circumferential position of the target or selected commissure of the prosthetic valve, when mounted on the delivery apparatus prior to the implantation procedure, relative to the radiopaque marker (e.g., marker 150) can be predetermined based on the fluoroscopic imaging view to be used during the implantation procedure. However, current systems and methods for mounting the prosthetic valve onto the delivery apparatus in a predetermined orientation relative to the radiopaque marker, and for deploying the prosthetic valve at the native valve, may not allow a user to select from a plurality of possible imaging views for imaging the heart and the position of the distal end portion of the delivery apparatus relative to the native valve (e.g., a three-cusp view vs. a cusp overlap view). For example, the systems and devices described above can, in some instances, be configured to achieve commissure alignment at the implantation site for a single (predetermined) fluoroscopic imaging view (e.g., the three-cusp imaging view).

[0189] Thus, it is desirable to have systems and methods for allowing a user to implant the prosthetic valve with commissures aligned with the native valve, using the same delivery apparatus, and using one out of a plurality of possible imaging views. Described below are various systems and / or methods that allow a user to select from two different imaging views and implant the prosthetic valve at a native valve with commissures aligned. In this way,different user preferences during an implantation procedure can be accommodated, while using the same mounting components and delivery apparatus.

[0190] In some examples, an alignment ring similar to the ring body 306 can have two sets of circumferentially offset indicators (e.g., indicators 360a-c being a first set) that each correspond to a different imaging view to be used with the delivery apparatus during an implantation procedure. In some examples, a user can select from two or more possible alignment rings, each with a unique set of indicators that correspond to a specific imaging view. As a result, the rotational position of the prosthetic valve on the support body (e.g., support body 301) can be determined by the selected alignment ring, which is based on the intended fluoroscopic imaging view to be used during the procedure. Additional details on such alignment rings or ring bodies can be found in PCT Patent Publication No. WO 2022 / 046585, which is already incorporated by reference above.

[0191] In some examples, a positioning device, such as the positioning device 600 shown in FIG.11, can be configured to couple to a distal end portion of a delivery apparatus (e.g., the distal end portion 109 of the delivery apparatus 100, similar to as shown in FIG.8) and couple to a crimping device (e.g., crimping device 650 shown in FIG.12) in two possible circumferential (or rotational) orientations, where each orientation corresponds to a different imaging view to be used during a valve implantation procedure with the delivery apparatus (for achieving commissure alignment, as described herein). The positioning device 600 can be similar to the positioning device 400, except it includes four circumferentially spaced apart extension portions 606 (instead of three) and two indicting elements 608, 610 (instead of one) that are spaced circumferentially apart from one another on the flange 604. The crimping device 650 can be similar to the crimping device 500 except for its number and arrangement of slots 696, as described further below.

[0192] For example, as shown in FIG.11, the positioning device 600 includes a body 602 with a central channel 612 that is configured to receive a shaft of a delivery apparatus (e.g., the intermediate shaft 106 of the delivery apparatus 100). The positioning device 600 includes the flange 604 extending radially outward from the body 602 at a distal end of the positioning device 600.

[0193] The flange 604 includes four extension portions 606, each configured to mate with a corresponding slot 696 in a proximal face 692 of a crimping device 650 (shown in FIG.12). The extension portions 606 can be configured the same or similar to the extension portions406 of positioning device 400 and the slots 696 can be configured the same or similar to the slots 596 of the crimping device 500. For example, each extension portion 606 can extend circumferentially along a portion of a perimeter of the flange 604. However, as shown in FIG.12, the crimping device 650 can include four circumferentially spaced apart slots 696 surrounding a channel 690 (instead of the three slots 596 of crimping device 500).

[0194] As shown in FIG.12, the proximal face 692 of the crimping device 650 can include a first indicator 670 (e.g., a “1”) and a second indicator 672 (e.g., a “2”) which visually depict to a user how to insert and lock the flange 604 of the positioning device 600 into the crimping device 650 such that the delivery apparatus (particularly the radiopaque marker 150) is held within the crimping device 650 in a predetermined circumferential orientation. In some examples, as shown in FIG.12, the first indicator 670 is radially aligned with a space between two adjacent slots 696 and the second indicator 672 is radially aligned with one of the two adjacent slots 696.

[0195] The flange 604 can include at least two indicating elements 608, 610 that can indicate an orientation of insertion of the extension portions 406 into the crimping device 500, for two or more possible imaging views. In some examples, as shown in FIG.11, the first indicating element 608 can be disposed adjacent to a first extension portion 606 and the second indicating element 610 can be disposed adjacent to a second extension portion 606. In some examples, the first and second extension portions 606 are adjacent to one another.

[0196] In some examples, the extension portions 606 are equally spaced around the flange 604, and as a result, the first indicating element 608 and the second indicating element 610 can be disposed 90 degrees apart from one another.

[0197] The first indicating element 608 can correspond to a first imaging view (e.g., the three-cusp view) to use for commissure alignment during an implantation procedure and the second indicating element 610 can correspond to a second imaging view (e.g., the cusp overlap or two-cusp view) to use for commissure alignment during an implantation procedure. In this way, the same positioning device 600 can be used for alignment of the delivery apparatus inside the crimping device 650 for two possible imaging views.

[0198] For example, for a first implantation procedure utilizing the three-cusp view for visualizing the radiopaque marker on the distal end portion of the delivery apparatus to achieve commissure alignment, a user can insert the flange 604 into a proximal opening 694 of the crimping device 650 which includes the slots 696 such that the first indicating element608 (which in some examples can be an arrow, as shown in FIG.11) is circumferentially or rotationally aligned with the first indicator 670 (e.g., the “1”). The user can then rotate the flange 604 (and thus the rest of the positioning device 600 and the delivery apparatus) until the indicating element 608 reaches the second indicator 672, thereby locking the extension portions 606 into the respective slots 696 and holding the delivery apparatus within the channel 690 of the crimping device 650 at a predetermined circumferential orientation. When both the positioning device 600 (coupled to the delivery apparatus) and the mounting assembly 300 (or a similar mounting assembly coupled to the prosthetic valve) are coupled to the crimping device 650, as described above, the prosthetic valve can be crimped to the delivery apparatus such that a selected commissure of the prosthetic valve is circumferentially offset from the corresponding marker on the delivery apparatus (e.g., marker 150) by a predetermined amount that will result in commissure alignment upon aligning the marker with the guidewire in the first imaging view (e.g., the three-cusp view) and deploying the prosthetic heart valve within the native valve with the delivery apparatus.

[0199] For a second implantation procedure utilizing the cusp overlap (or two-cusp) view for visualizing the radiopaque marker on the distal end portion of the delivery apparatus to achieve commissure alignment, a user can insert the flange 604 into a proximal opening 694 of the crimping device 650 which includes the slots 696 such that the second indicating element 610 (which in some examples can be an arrow, as shown in FIG.11) is circumferentially or rotationally aligned with the first indicator 670 (e.g., the “1”). The user can then rotate the flange 604 (and thus the rest of the positioning device 600 and the delivery apparatus) until the second indicating element 610 reaches the second indicator 672, thereby locking the extension portions 606 into the respective slots 696 and holding the delivery apparatus within the channel 690 of the crimping device 650 at a predetermined circumferential orientation. When both the positioning device 600 (coupled to the delivery apparatus) and the mounting assembly 300 (coupled to the prosthetic valve) are coupled to the crimping device 650, as described above, the prosthetic valve can be crimped to the delivery apparatus such that a selected commissure is circumferentially offset from the corresponding marker on the delivery apparatus (e.g., marker 150) by a predetermined amount that will result in commissure alignment upon aligning the marker with the guidewire in the second imaging view (e.g., the cusp overlap view) and deploying the prosthetic heart valve within the native valve with the delivery apparatus.

[0200] In some examples, the delivery apparatus 100 can have multiple radiopaque markers on its distal end portion 109 which correspond to different specified imaging views to be used to visualize the distal end portion 109 at the native valve during an implantation procedure. For example, as introduced above, different medical professionals may have difference preferences as to which fluoroscopic imaging view to use during an implantation procedure for visualizing the delivery apparatus and implanting the prosthetic valve with commissures aligned with the native valve. By utilizing two or more radiopaque markers that are circumferentially offset from one another on the distal end portion 109 of the delivery apparatus 100, the same delivery apparatus 100 can be used by a variety of users that use different imaging views during a prosthetic valve implantation procedure.

[0201] For example, in some instances the radiopaque marker 150 on the distal end portion 109 of the delivery apparatus 100 (as shown in FIG.2C) can be a first radiopaque marker 150 (shown in FIG.2C) and the delivery apparatus 100 can include a second radiopaque marker 156 (as shown in FIG.13A). In some examples, the first radiopaque marker 150 can be the marker used for achieving commissure alignment during an implantation procedure when using a first imaging view, such as the three-cusp view, and the second radiopaque marker 156 can be the marker used for achieving commissure alignment during an implantation procedure when using a second imaging view, such as the cusp overlap or two-cusp view.

[0202] As such, in some examples, the second radiopaque marker 156 can be a “2” (for two- cusp view), as shown in FIGS.13A-15.

[0203] In some examples, the first radiopaque marker 150 is a “C” (as shown in FIGS.2C and 13B).

[0204] In some examples, the first radiopaque marker 150 can be a “3” (for three-cusp view), as shown in FIG.14.

[0205] Both the first radiopaque marker 150 and the second radiopaque marker 156 can be asymmetric markers, as described herein. By being asymmetric, or reflection asymmetric along an axis that is parallel to the central longitudinal axis of the delivery apparatus, under medical imaging (e.g., fluoroscopy) a position of the markers 150 and / or 156 within the imaging view, relative to the guidewire, can be more easily discerned. For example, when the first radiopaque marker 150 is aligned with the guidewire such that it is readable (frontwards) in the three-cusp imaging view, the prosthetic valve can be deployed with the delivery apparatus and implanted with commissure aligned with the native valve. As anotherexample, when the second radiopaque marker 156 is aligned with the guidewire such that it is readable (frontwards) in the two-cusp (or cusp overlap) imaging view, the prosthetic valve can be deployed with the delivery apparatus and implanted with commissure aligned with the native valve.

[0206] As shown in FIGS.13B and 14, in some examples, the first radiopaque marker 150 and the second radiopaque marker 156 can each be positioned on or in a different wing 130 of the distal shoulder 126.

[0207] In some examples, as shown in FIGS.13B and 14, the first radiopaque marker 150 and the second radiopaque marker 156 are disposed in or on adjacent wings 130. Since the distal shoulder 126 includes four circumferentially spaced apart wings 130, the first radiopaque marker 150 and the second radiopaque marker 156 can be disposed approximately 90 degrees apart from one another on or in the distal shoulder 126. This can account for the difference in orientation between the two imaging views (three-cusp and two-cusp views). In some examples, the target native valve commissure for aligning with the specified commissure of the prosthetic valve can be approximately 90 degrees different between the two imaging views.

[0208] In some examples of the delivery apparatus 100, such as the version shown in FIG. 14, by utilizing a “3” for the first radiopaque marker 150 and a “2” for the second radiopaque marker 156, it may be more intuitive for a medical professional to quickly select the correct radiopaque marker for alignment during an implantation procedure using a selected imaging view (e.g., the three-cusp or two-cusp view).

[0209] In this way, the same delivery apparatus can be used by multiple users with different imaging view preferences.

[0210] Further, in some examples, the same mounting assembly and / or positioning device, such as the mounting assembly 300 and / or the positioning device 400 described herein, can be used with the same delivery apparatus and both the first and second radiopaque markers 150 and 156. In such instances, the positioning device 400 can be coupled to the delivery apparatus 100 in a specified circumferential orientation relative to the selected radiopaque marker (marker 150 or marker 156) so that the prosthetic valve 50 is mounted and radially compressed onto the valve mounting portion 124 of the delivery apparatus 100 such that a specified commissure 64 is circumferentially offset from the selected radiopaque marker (the second radiopaque marker 156 shown in the example of FIG.15) by a predetermined offset190, as shown in FIG.15. The other radiopaque marker (e.g., the first radiopaque marker 150) is then offset from the specified commissure 64 by 90 degrees minus the offset 190.

[0211] In alternate examples, the prosthetic valve 50 can be mounted and radially compressed onto the valve mounting portion 124 of the delivery apparatus 100 such that a specified commissure 64 is circumferentially offset from the first marker 150 by a predetermined offset and the other radiopaque marker (the second radiopaque marker 156) is then offset from the specified commissure 64 by 90 degrees minus the offset. For example, in some examples, the first radiopaque marker 150 can replace the second radiopaque marker in FIG.15.

[0212] In some examples, the predetermined offset 190 can be based on amount of rotation the prosthetic valve experiences during radial expansion by the balloon of the delivery apparatus (e.g., due to the folding or pleating of the balloon).

[0213] FIGS.16-19 show exemplary use of the delivery apparatus 100 including the first radiopaque marker 150 and the second radiopaque marker 156 during a first implantation procedure utilizing the three-cusp view (FIGS.16 and 17) and during a second implantation procedure utilizing the two-cusp (or cusp overlap) view (FIGS.18 and 19).

[0214] Turning first to FIGS.16 and 17, FIG.16 is a schematic of a three-cusp imaging view 700 of the native valve 260 and the distal end portion 109 of the delivery apparatus 100 at or adjacent to the native valve 260. FIG.17 is a schematic of a cross-sectional view 710 of the native valve 260, for the three-cusp imaging view. During the first implantation procedure, when the distal end portion 109 is at or adjacent the native valve 260, the delivery apparatus can be rotated until the first radiopaque marker 150 appears in a forward readable or preselected orientation (e.g., the forward C shown in FIG.16) and is aligned with the guidewire 154. As a result, the first radiopaque marker 150 can be in a direct back of the imaging view, aligned with the specified commissure 262 of the native valve 260, as shown in FIG.17. As introduced above, and depicted in FIG.17, a specified commissure 64 of the prosthetic valve 50 can be mounted onto the delivery apparatus with a predetermined offset from the first radiopaque marker 150. As such, when the prosthetic valve 50 is deployed with the delivery apparatus 100, the prosthetic valve 50 can rotate as it radially expands (as depicted by arrow 702), thereby resulting in the commissure 64 being aligned with the specified commissure 262 of the native valve 260 upon implantation inside the native valve 260.

[0215] During the second implantation procedure using the two-cusp view, the second radiopaque marker 156 is used for alignment at the native valve. For example, FIG.18 is a schematic of a two-cusp (or cusp overlap) imaging view 720 of the native valve 260 and the distal end portion 109 of the delivery apparatus 100 at or adjacent to the native valve 260. FIG.19 is a schematic of a cross-sectional view 730 of the native valve 260, for the two-cusp imaging view. During the second implantation procedure, when the distal end portion 109 is at or adjacent the native valve 260, the delivery apparatus can be rotated until the second radiopaque marker 156 appears in a forward readable or preselected orientation (e.g., the forward 2 shown in FIG.18) and is aligned with the guidewire 154. As a result, the second radiopaque marker 156 can be in a direct back of the imaging view and offset from the specified commissure 262 of the native valve 260 by a known amount, as shown in FIG.19 (e.g., in this instance, about 90 degrees). Thus, when the prosthetic valve 50 is deployed with the delivery apparatus 100, the prosthetic valve 50 can rotate as it radially expands (as depicted by arrow 722), thereby resulting in the commissure 64 being aligned with the specified commissure 262 of the native valve 260 upon implantation inside the native valve 260.

[0216] By utilizing a delivery apparatus with two radiopaque markers disposed on the distal end portion (e.g., the distal shoulder) 90 degrees apart, the same mounting assemblies and delivery apparatus can be used for two different imaging views (the 2-cusp or 3-cusp views).

[0217] In this way, the delivery apparatus or components for mounting a prosthetic valve onto a delivery apparatus described herein can be adapted such that the same delivery apparatus can be used to achieve commissure alignment in different implantation procedures utilizing different imaging views.

[0218] In some examples, one or more of the above-described apparatuses and methods can be applied to and modified for a self-expanding prosthetic valve (and methods of implanting self-expanding prosthetic valves). For example, a self-expanding valve can be mounted on a distal end portion of a delivery apparatus and a sheath or capsule of the delivery apparatus can cover the prosthetic valve and hold it in a radially compressed state for delivery to a target implantation site (for example, a native valve). In some examples, the two radiopaque markers described herein (for example, the first radiopaque marker 150 and the second radiopaque marker 156) can be disposed on the nosecone or the sheath / capsule of the delivery apparatus. The self-expanding prosthetic valve can be mounted onto the delivery apparatussuch that the first radiopaque marker 150 is aligned (circumferentially) with a specified commissure of the prosthetic valve (without an offset). A method for implanting the prosthetic valve with such a delivery apparatus can include rotating the distal end portion of the delivery apparatus (and the two radiopaque markers and the valve) until the selected radiopaque marker for the selected imaging view (the first or second radiopaque marker) is aligned with the guidewire in the imaging view. The delivery apparatus can then be actuated to radially expand and implant the prosthetic valve at the implantation site with commissures aligned with those of the native valve (for example, by moving the sheath or capsule away from and off the prosthetic valve such that the prosthetic valve self-expands within the native valve). Delivery Techniques a prosthetic valve within the native aortic valve via a transfemoraldelivery 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 aortic valve. 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-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0220] 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 theinferior 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.

[0221] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0222] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0223] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

[0224] 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 / thermalsterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Simulation

[0225] 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

[0226] 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.

[0227] Example 1. A delivery apparatus comprising: a rotatable first shaft that is configured to rotate around a central longitudinal axis of the delivery apparatus to rotationally align a prosthetic valve mounted on the delivery apparatus with native anatomy at a target implantation site; a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft; a polymeric body mounted on the distal end portion of the second shaft; a first radiopaque marker disposed on the polymeric body; and a second radiopaque marker disposed on the polymeric body, wherein the first and second radiopaque markers are spaced circumferentially apart from one another.

[0228] Example 2. The delivery apparatus of any example herein, particularly example 1, further comprising an inflatable balloon coupled to the distal end portion of the first shaft.

[0229] Example 3. The delivery apparatus of any example herein, particularly example 2, wherein the polymeric body is disposed within a distal end portion of the inflatable balloon.

[0230] Example 4. The delivery apparatus of any example herein, particularly any one of examples 1-3, wherein the polymeric body is disposed adjacent to a valve mounting portion of the distal end portion of the second shaft.

[0231] Example 5. The delivery apparatus of any example herein, particularly any one of examples 1-4, wherein the first and second radiopaque markers are asymmetric markers that are each reflection asymmetric along an axis that is parallel to the central longitudinal axis.

[0232] Example 6. The delivery apparatus of any example herein, particularly example 5, wherein the first radiopaque marker is C-shaped.

[0233] Example 7. The delivery apparatus of any example herein, particularly example 5, wherein the first radiopaque marker is shaped as a number 3.

[0234] Example 8. The delivery apparatus of any example herein, particularly any one of examples 5-7, wherein the second radiopaque marker is shaped as a number 2.

[0235] Example 9. The delivery apparatus of any example herein, particularly any one of examples 1-8, wherein the first and second radiopaque markers are spaced circumferentially apart from one another by 90 degrees.

[0236] Example 10. The delivery apparatus of any example herein, particularly any one of examples 1-9, wherein the polymeric body is a distal shoulder disposed distal to a valve mounting portion of the distal end portion of the second shaft.

[0237] Example 11. The delivery apparatus of any example herein, particularly example 10, wherein the distal shoulder comprises a base portion and a flared portion that extends radially outward from the base portion such that the flared portion is disposed radially outward from an outer surface of the second shaft, and wherein the first and second radiopaque markers are mounted on or embedded within the flared portion of the distal shoulder.

[0238] Example 12. The delivery apparatus of any example herein, particularly example 11, wherein the flared portion comprises a plurality of wings spaced circumferentially apart from one another, wherein the first radiopaque marker is disposed on a first wing of the plurality of wings, and wherein the second radiopaque marker is disposed on a second wing of the plurality of wings.

[0239] Example 13. The delivery apparatus of any example herein, particularly example 12, wherein the first and second wings are adjacent to one another.

[0240] Example 14. The delivery apparatus of any example herein, particularly any one of examples 10-13, further comprising a nose cone coupled to the distal shoulder, wherein the nose cone is disposed distal to the distal shoulder.

[0241] Example 15. The delivery apparatus of any example herein, particularly any one of examples 1-14, further comprising one or more radiopaque marker bands mounted onto the second shaft.

[0242] Example 16. The delivery apparatus of any example herein, particularly any one of examples 1-15, wherein the first shaft is arranged within and configured to rotate relative to a third shaft of the delivery apparatus, and further comprising a handle portion including a steering mechanism configured to selectively adjust a curvature of the third shaft.

[0243] Example 17. The delivery apparatus of any example herein, particularly any one of examples 1-16, further comprising a handle including one or more adjustment mechanisms configured to adjust operation of the delivery apparatus, wherein the first shaft extends distally from the handle, wherein the first shaft has a proximal end portion that extends proximally from the handle, and further comprising a rotatable knob mounted on the proximal end portion of the first shaft, the knob configured to rotate the first shaft.

[0244] Example 18. An assembly comprising the delivery apparatus of any example herein, particularly any one of examples 1-17, and further comprising: a prosthetic heart valve mounted in a radially compressed configuration onto and around a valve mounting portion of the distal end portion of the second shaft, wherein the polymeric body is axially offset from the prosthetic heart valve.

[0245] Example 19. The assembly of any example herein, particularly example 18, further comprising a guidewire that extends through a lumen of the second shaft.

[0246] Example 20. A delivery apparatus comprising: a first radiopaque marker positioned along a distal end portion of the delivery apparatus, wherein the first radiopaque marker is reflection asymmetric along an axis that is parallel to a central longitudinal axis of the delivery apparatus; and a second radiopaque marker positioned along the distal end portion of the delivery apparatus, wherein the first and second radiopaque markers are spaced apart from one another in a circumferential direction, and wherein the second radiopaque marker is reflection asymmetric along an axis that is parallel to the central longitudinal axis.

[0247] Example 21. The delivery apparatus of any example herein, particularly example 20, wherein the first and second radiopaque markers are disposed at a same axial position along the distal end portion of the delivery apparatus.

[0248] Example 22. The delivery apparatus of any example herein, particularly either example 20 or example 21, wherein the first radiopaque marker is C-shaped.

[0249] Example 23. The delivery apparatus of any example herein, particularly either example 20 or example 21, wherein the first radiopaque marker is shaped as a number 3.

[0250] Example 24. The delivery apparatus of any example herein, particularly any one of examples 20-23, wherein the second radiopaque marker is shaped as a number 2.

[0251] Example 25. The delivery apparatus of any example herein, particularly any one of examples 20-24, wherein the first and second radiopaque markers are spaced circumferentially apart from one another by 90 degrees.

[0252] Example 26. The delivery apparatus of any example herein, particularly any one of examples 20-25, further comprising a shaft and a polymeric body mounted on a distal end portion of the shaft, and wherein the first and second radiopaque markers are disposed on the polymeric body.

[0253] Example 27. The delivery apparatus of any example herein, particularly example 26, wherein the polymeric body is a distal shoulder disposed distal to a valve mounting portion of the distal end portion of the shaft.

[0254] Example 28. The delivery apparatus of any example herein, particularly example 27, wherein the distal shoulder comprises a base portion and a flared portion that extends radially outward from the base portion such that the flared portion is disposed radially outward from an outer surface of the shaft, and wherein the first and second radiopaque markers are mounted on or embedded within the flared portion of the distal shoulder.

[0255] Example 29. The delivery apparatus of any example herein, particularly example 28, wherein the flared portion comprises a plurality of wings spaced circumferentially apart from one another, wherein the first radiopaque marker is disposed on a first wing of the plurality of wings, and wherein the second radiopaque marker is disposed on a second wing of the plurality of wings.

[0256] Example 30. The delivery apparatus of any example herein, particularly example 29, wherein the first and second wings are adjacent to one another.

[0257] Example 31. The delivery apparatus of any example herein, particularly any one of examples 27-30, further comprising a nose cone coupled to the distal shoulder, wherein the nose cone is disposed distal to the distal shoulder.

[0258] Example 32. The delivery apparatus of any example herein, particularly any one of examples 20-31, further comprising one or more radiopaque marker bands mounted on the shaft.

[0259] Example 33. The delivery apparatus of any example herein, particularly any one of examples 20-32, further comprising an inflatable balloon disposed around the distal end portion of the shaft, and wherein the polymeric body is disposed within a distal end portion of the inflatable balloon.

[0260] Example 34. An assembly comprising the delivery apparatus of any example herein, particularly any one of examples 20-33, and further comprising: a prosthetic heart valve mounted in a radially compressed configuration onto and around a valve mounting portion of the distal end portion of the shaft, wherein the polymeric body is axially offset from the prosthetic heart valve.

[0261] Example 35. The assembly of any example herein, particularly example 34, further comprising a guidewire that extends through a lumen of the shaft.

[0262] Example 36. A method comprising: advancing a distal end portion of a delivery apparatus toward a native valve of a heart, wherein a prosthetic heart valve is radially compressed around a distal end portion of the delivery apparatus, at a valve mounting portion of the delivery apparatus; selecting a fluoroscopic imaging view out of a first fluoroscopic imaging view and a second fluoroscopic imaging view to be used during an implantation procedure; and for a first fluoroscopic imaging view: visualizing under fluoroscopy, a position of a first radiopaque marker positioned along a distal end portion of a shaft of the delivery apparatus relative to a guidewire extending through the shaft, wherein the first radiopaque marker is reflection asymmetric along an axis that is parallel to a central longitudinal axis of the delivery apparatus; rotating the shaft of the delivery apparatus, which rotates the prosthetic heart valve and the first radiopaque marker, until the first radiopaque marker is centered along the guidewire and is in a predetermined orientation in the first fluoroscopic imaging view; and radially expanding the prosthetic heart valve to implant the prosthetic heart valve in the native valve such that commissures of the prosthetic heart valve are aligned with commissures of the native valve; and for a second fluoroscopic imagingview: visualizing under fluoroscopy, a position of a second radiopaque marker positioned along the distal end portion of the shaft of the delivery apparatus relative to the guidewire extending through the shaft, wherein the second radiopaque marker is circumferentially offset from the first radiopaque marker, and wherein the second radiopaque marker is reflection asymmetric along an axis that is parallel to the central longitudinal axis of the delivery apparatus; rotating the shaft of the delivery apparatus, which rotates the prosthetic heart valve and the second radiopaque marker, until the second radiopaque marker is centered along the guidewire and is in a predetermined orientation in the second fluoroscopic imaging view; and radially expanding the prosthetic heart valve to implant the prosthetic heart valve in the native valve such that commissures of the prosthetic heart valve are aligned with commissures of the native valve.

[0263] Example 37. The method of any example herein, particularly example 36, wherein the first fluoroscopic imaging view is a three-cusp imaging view.

[0264] Example 38. The method of any example herein, particularly either example 36 or example 37, wherein the second fluoroscopic imaging view is a cusp overlap imaging view.

[0265] Example 39. The method of any example herein, particularly any one of examples 36-38, wherein the first radiopaque marker is shaped as a C and the second radiopaque marker is shaped as a number 2.

[0266] Example 40. The method of any example herein, particularly any one of examples 36-38, wherein the first radiopaque marker is shaped as a number 3 and the second radiopaque marker is shaped as a number 2.

[0267] Example 41. The method of any example herein, particularly any one of examples 36-40, wherein the shaft is a first shaft, wherein the first shaft extends through and distally beyond a second shaft of the delivery apparatus, and wherein rotating the shaft of the delivery apparatus includes rotating a knob disposed on a proximal end portion of the second shaft, which also rotates the first shaft.

[0268] Example 42. The method of any example herein, particularly example 41, wherein the prosthetic heart valve is radially compressed around a balloon of the delivery apparatus, and wherein the balloon is coupled to a distal end of the second shaft.

[0269] Example 43. The method of any example herein, particularly any one of examples 36-42, wherein the first and second radiopaque markers are disposed on a polymeric bodythat is mounted on the distal end portion of the shaft, and wherein the first and second radiopaque markers are circumferentially offset from one another by 90 degrees.

[0270] Example 44. A method comprising: selecting a fluoroscopic imaging view out of two or more possible fluoroscopic imaging views to be used during an implantation procedure and selecting a first radiopaque marker out of two or more radiopaque markers based on the selected imaging view, where the two or more radiopaque markers are circumferentially offset from one another on a polymeric body mounted on a distal end portion of a shaft of a delivery apparatus; advancing the distal end portion of the shaft of the delivery apparatus toward a native valve of a heart, wherein a prosthetic heart valve is radially compressed around an inflatable balloon of the delivery apparatus, at a valve mounting portion of the delivery apparatus; visualizing in the selected fluoroscopic imaging view, a position of the first radiopaque marker relative to a guidewire extending through the shaft, wherein the first radiopaque marker is reflection asymmetric along an axis that is parallel to a central longitudinal axis of the delivery apparatus; rotating the shaft of the delivery apparatus, which rotates the prosthetic heart valve and the first radiopaque marker, until the first radiopaque marker is centered along the guidewire and is in a predetermined orientation in the selected fluoroscopic imaging view; and inflating the balloon to radially expand and implant the prosthetic heart valve in the native valve such that commissures of the prosthetic heart valve are aligned with commissures of the native valve.

[0271] Example 45. The method of any example herein, particularly example 44, wherein the selected fluoroscopic imaging view is a three-cusp imaging view.

[0272] Example 46. The method of any example herein, particularly example 44, wherein the selected fluoroscopic imaging view is a cusp overlap imaging view.

[0273] Example 47. The method of any example herein, particularly any one of examples 44-46, wherein the first radiopaque marker is shaped as a C and the two or more radiopaque markers include a second radiopaque marker that is shaped as a number 2.

[0274] Example 48. The method of any example herein, particularly any one of examples 44-46 wherein the first radiopaque marker is shaped as a number 3 and the two or more radiopaque markers include a second radiopaque marker that is shaped as a number 2.

[0275] Example 49. The method of any example herein, particularly any one of examples 44-48, wherein the shaft is a first shaft, wherein the first shaft extends through and distally beyond a second shaft of the delivery apparatus, and wherein rotating the shaft of the deliveryapparatus includes rotating a knob disposed on a proximal end portion of the second shaft, which also rotates the first shaft.

[0276] Example 50. The method of any example herein, particularly example 49, wherein the balloon is coupled to a distal end of the second shaft.

[0277] Example 51. The method of any example herein, particularly any one of examples 44-50, wherein the polymeric body is a distal shoulder mounted on the distal end portion of the shaft, distal to the prosthetic heart valve when the prosthetic heart valve is radially compressed around the balloon, and wherein the distal shoulder is configured to resist movement of the prosthetic heart valve relative to the balloon when the prosthetic heart valve is radially compressed around the balloon.

[0278] Example 52. An assembly comprising: a crimping device having a channel and an opening to the channel on a first face of the crimping device, wherein the opening includes a plurality of circumferentially spaced apart slots, and wherein the first face includes a first indicator and a second indicator spaced circumferentially apart from one another adjacent to the opening; and a positioning device comprising a body and a flange extending radially outward from the body at a distal end of the positioning device, wherein the flange comprises a plurality of circumferentially spaced apart extension portions and first and second indicating elements, wherein the first indicating element is disposed adjacent to a first extension portion of the plurality of extension portions and the second indicating element is disposed adjacent to a second extension portion of the plurality of extension portions, wherein the plurality of extension portions is configured to couple to the plurality of slots in two different orientations, wherein in a first orientation the first indicating element is aligned with the second indicator of the crimping device, and wherein in a second orientation the second indicating element is aligned with the second indicator of the crimping device.

[0279] Example 53. The assembly of any example herein, particularly example 52, wherein the flange of the positioning device is rotatable within the opening of the crimping device from a first position where the first or second indicating element is aligned with the first indicator to a second position where the first or second indicating element is aligned with the second indicator such that the flange is locked in place to the crimping device.

[0280] Example 54. The assembly of any example herein, particularly either example 52 or example 53, wherein the first indicator of the crimping device is radially aligned with a spacebetween two adjacent slots of the plurality of slots, and wherein the second indicator of the crimping device is radially aligned with one of the two adjacent slots.

[0281] Example 55. The assembly of any example herein, particularly any one of examples 52-54, wherein each extension portion of the plurality of extension portions extends circumferentially along a portion of a perimeter of the flange.

[0282] Example 56. The assembly of any example herein, particularly any one of examples 52-55, wherein the first indicating element and the second indicating element are arrows.

[0283] Example 57. The assembly of any example herein, particularly any one of examples 52-56, wherein the plurality of slots includes four slots, and the plurality of extension portions includes four extension portions.

[0284] Example 58. The assembly of any example herein, particularly any one of examples 52-57, further comprising a delivery apparatus for a prosthetic device, and wherein the body of the positioning device is configured to couple around a distal end portion of a shaft of the delivery apparatus.

[0285] Example 59. The assembly of any example herein, particularly any one of examples 52-58, wherein an opposite, second face of the crimping device comprises mating elements configured to mate with a mounting assembly for a prosthetic heart valve.

[0286] Example 60. An assembly comprising: a delivery apparatus for a prosthetic device comprising a shaft and a valve mounting portion along a portion of the shaft; a crimping device having a channel and an opening to the channel on a first face of the crimping device, wherein the opening includes a plurality of circumferentially spaced apart slots; and a positioning device comprising a body and a flange extending radially outward from the body at a distal end of the positioning device, wherein the body is configured to couple to the shaft, proximal to the valve mounting portion, wherein the flange comprises a plurality of circumferentially spaced apart extension portions, and wherein the plurality of extension portions are configured to mate with the plurality of slots in two different orientations which are circumferentially offset from one another.

[0287] Example 61. The assembly of any example herein, particularly example 60, wherein the plurality of slots includes four slots, and the plurality of extension portions includes four extension portions.

[0288] Example 62. The assembly of any example herein, particularly either example 60 or example 61, wherein the flange includes first and second indicating elements that indicatefirst and second orientations, respectively, of insertion of the plurality of extension portions into the crimping device, and wherein the first indicating element is disposed adjacent to a first extension portion of the plurality of extension portions and the second indicating element is disposed adjacent to a second extension portion of the plurality of extension portions.

[0289] Example 63. The assembly of any example herein, particularly example 62, wherein the first face includes a first indicator and a second indicator spaced circumferentially apart from one another adjacent to the opening, and wherein the flange of the positioning device is rotatable within the opening of the crimping device from a first position where the first or second indicating element is aligned with the first indicator to a second position where the first or second indicating element is aligned with the second indicator such that the flange is locked in place within the crimping device.

[0290] Example 64. The assembly of any example herein, particularly example 63, wherein the first indicator of the crimping device is radially aligned with a space between two adjacent slots of the plurality of slots, and wherein the second indicator of the crimping device is radially aligned with one of the two adjacent slots.

[0291] Example 65. The assembly of any example herein, particularly any one of examples 60-64, wherein each extension portion of the plurality of extension portions extends circumferentially along a portion of a perimeter of the flange.

[0292] Example 66. The assembly of any example herein, particularly any one of examples 60-65, further comprising a mounting assembly comprising a support surface configured to receive the prosthetic device and an alignment member configured to mate with a recess on an opposite, second face of the crimping device.

[0293] Example 67. A method comprising: coupling a body of a positioning device to a shaft of a delivery apparatus, adjacent to a valve mounting portion of the delivery apparatus, wherein the positioning device comprises a flange extending radially outward from the body at a distal end of the positioning device, and wherein the flange comprises a plurality of circumferentially spaced apart extension portions; selecting between a first fluoroscopic imaging view and a second fluoroscopic imaging view to be used during an implantation procedure with the delivery apparatus; and for a first fluoroscopic imaging view to be used during a first implantation procedure with the delivery apparatus, coupling the flange to a side of a crimping device such that the plurality of extension portions mate with a plurality of complementary slots in an opening to a channel of the crimping device and the valvemounting portion of the delivery apparatus is held within the channel in a first circumferential orientation; and for a second fluoroscopic imaging view to be used during a second implantation procedure with the delivery apparatus, coupling the flange to the side of the crimping device such that the plurality of extension portions mate with the plurality of complementary slots and the valve mounting portion of the delivery apparatus is held within the channel in a second circumferential orientation.

[0294] Example 68. The method of any example herein, particularly example 67, further comprising crimping a prosthetic heart valve held within the channel of the crimping device onto the valve mounting portion of the delivery apparatus using the crimping device while the valve mounting portion is held in the channel in the first circumferential orientation or the second circumferential orientation.

[0295] Example 69. The method of any example herein, particularly either example 67 or example 68, wherein the coupling the body of the positioning device to the shaft of the delivery apparatus includes coupling the positioning device to the shaft of the delivery apparatus in a specified circumferential orientation relative to a radiopaque marker on a distal end portion of the delivery apparatus.

[0296] Example 70. The method of any example herein, particularly example 69, wherein the radiopaque marker is an asymmetric marker.

[0297] Example 71. The method of any example herein, particularly any one of examples 67-70, wherein the flange includes a first indicating element and a second indicating element that are spaced circumferentially apart from one another on the flange, and wherein the side of the crimping device includes a first indicator and a second indicator that are spaced circumferentially apart and disposed adjacent to the opening of the channel.

[0298] Example 72. The method of any example herein, particularly example 71, wherein the coupling the flange to the side of the crimping device such that the valve mounting portion is held within the channel in the first circumferential orientation includes inserting the flange into the opening such that the first indicating element aligns with the first indicator and rotating the flange within the opening until the first indicating element aligns with the second indicator.

[0299] Example 73. The method of any example herein, particularly example 71, wherein the coupling the flange to the side of the crimping device such that the valve mounting portion is held within the channel in the second circumferential orientation includes insertingthe flange into the opening such that the second indicating element aligns with the first indicator and rotating the flange within the opening until the second indicating element aligns with the second indicator.

[0300] Example 74. The method of any example herein, particularly any one of examples 71-73, wherein the first indicating element is disposed adjacent to a first extension portion of the plurality of extension portions and the second indicating element is disposed adjacent to a second extension portion of the plurality of extension portions.

[0301] Example 75. The method of any example herein, particularly any one of examples 67-75, wherein the first and second circumferential orientations are offset by 90 degrees.

[0302] Example 76. A method comprising sterilizing the prosthetic heart valve, apparatus, and / or assembly of any example.

[0303] Example 77. A prosthetic heart valve of any one of examples 1-76, wherein the prosthetic heart valve is sterilized.

[0304] 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 delivery apparatus can be combined with any one or more features of another delivery apparatus. As another example, any one or more features of one positioning device, mounting assembly, or crimping device can be combined with any one or more features of another positioning device, mounting assembly, or crimping device.

[0305] 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

WE CLAIM:

1. A delivery apparatus comprising: a rotatable first shaft that is configured to rotate around a central longitudinal axis of the delivery apparatus to rotationally align a prosthetic valve mounted on the delivery apparatus with native anatomy at a target implantation site; a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft; a polymeric body mounted on the distal end portion of the second shaft; a first radiopaque marker disposed on the polymeric body; and a second radiopaque marker disposed on the polymeric body, wherein the first and second radiopaque markers are spaced circumferentially apart from one another.

2. The delivery apparatus of claim 1, further comprising an inflatable balloon coupled to the distal end portion of the first shaft.

3. The delivery apparatus of claim 2, wherein the polymeric body is disposed within a distal end portion of the inflatable balloon.

4. The delivery apparatus of any one of claims 1-3, wherein the polymeric body is disposed adjacent to a valve mounting portion of the distal end portion of the second shaft.

5. The delivery apparatus of any one of claims 1-4, wherein the first and second radiopaque markers are asymmetric markers that are each reflection asymmetric along an axis that is parallel to the central longitudinal axis.

6. The delivery apparatus of any one of claims 1-5, wherein the first and second radiopaque markers are spaced circumferentially apart from one another by 90 degrees.

7. The delivery apparatus of any one of claims 1-6, wherein the polymeric body is a distal shoulder disposed distal to a valve mounting portion of the distal end portion of the second shaft.

8. The delivery apparatus of claim 7, wherein the distal shoulder comprises a base portion and a flared portion that extends radially outward from the base portion such that the flared portion is disposed radially outward from an outer surface of the second shaft, and wherein the first and second radiopaque markers are mounted on or embedded within the flared portion of the distal shoulder.

9. The delivery apparatus of claim 8, wherein the flared portion comprises a plurality of wings spaced circumferentially apart from one another, wherein the first radiopaque marker is disposed on a first wing of the plurality of wings, and wherein the second radiopaque marker is disposed on a second wing of the plurality of wings.

10. The delivery apparatus of any one of claims 1-9, further comprising one or more radiopaque marker bands mounted onto the second shaft.

11. An assembly comprising the delivery apparatus of any one of claims 1-10, and further comprising: a prosthetic heart valve mounted in a radially compressed configuration onto and around a valve mounting portion of the distal end portion of the second shaft, wherein the polymeric body is axially offset from the prosthetic heart valve.

12. The assembly of claim 11, further comprising a guidewire that extends through a lumen of the second shaft.

13. A delivery apparatus comprising: a first radiopaque marker positioned along a distal end portion of the delivery apparatus, wherein the first radiopaque marker is reflection asymmetric along an axis that is parallel to a central longitudinal axis of the delivery apparatus; and a second radiopaque marker positioned along the distal end portion of the delivery apparatus, wherein the first and second radiopaque markers are spaced apart from one another in a circumferential direction, and wherein the second radiopaque marker is reflection asymmetric along an axis that is parallel to the central longitudinal axis.

14. The delivery apparatus of claim 13, wherein the first and second radiopaque markers are disposed at a same axial position along the distal end portion of the delivery apparatus.

15. The delivery apparatus of either claim 13 or claim 14, wherein the first radiopaque marker is C-shaped.

16. The delivery apparatus of either claim 13 or claim 14, wherein the first radiopaque marker is shaped as a number 3.

17. The delivery apparatus of any one of claims 13-16, wherein the second radiopaque marker is shaped as a number 2.

18. The delivery apparatus of any one of claims 13-17, wherein the first and second radiopaque markers are spaced circumferentially apart from one another by 90 degrees.

19. The delivery apparatus of any one of claims 13-18, further comprising a shaft and a polymeric body mounted on a distal end portion of the shaft, and wherein the first and second radiopaque markers are disposed on the polymeric body.

20. A method comprising: selecting a fluoroscopic imaging view out of two or more possible fluoroscopic imaging views to be used during an implantation procedure and selecting a first radiopaque marker out of two or more radiopaque markers based on the selected imaging view, where the two or more radiopaque markers are circumferentially offset from one another on a polymeric body mounted on a distal end portion of a shaft of a delivery apparatus; advancing the distal end portion of the shaft of the delivery apparatus toward a native valve of a heart, wherein a prosthetic heart valve is radially compressed around an inflatable balloon of the delivery apparatus, at a valve mounting portion of the delivery apparatus;visualizing in the selected fluoroscopic imaging view, a position of the first radiopaque marker relative to a guidewire extending through the shaft, wherein the first radiopaque marker is reflection asymmetric along an axis that is parallel to a central longitudinal axis of the delivery apparatus; rotating the shaft of the delivery apparatus, which rotates the prosthetic heart valve and the first radiopaque marker, until the first radiopaque marker is centered along the guidewire and is in a predetermined orientation in the selected fluoroscopic imaging view; and inflating the balloon to radially expand and implant the prosthetic heart valve in the native valve such that commissures of the prosthetic heart valve are aligned with commissures of the native valve.

21. The method of claim 20, wherein the selected fluoroscopic imaging view is a three-cusp imaging view.

22. The method of claim 20, wherein the selected fluoroscopic imaging view is a cusp overlap imaging view.

23. The method of any one of claims 20-22 wherein the first radiopaque marker is shaped as a number 3 and the two or more radiopaque markers include a second radiopaque marker that is shaped as a number 2.

24. The method of any one of claims 20-23, wherein the polymeric body is a distal shoulder mounted on the distal end portion of the shaft, distal to the prosthetic heart valve when the prosthetic heart valve is radially compressed around the balloon, and wherein the distal shoulder is configured to resist movement of the prosthetic heart valve relative to the balloon when the prosthetic heart valve is radially compressed around the balloon.

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