Alignment device for a prosthetic implant

Abstract

An alignment device for crimping a prosthetic valve onto a delivery apparatus is disclosed. The alignment device can include a coupling portion configured to couple with a crimping device, a support portion that tapers from a wider end that is disposed adjacent a first end of the coupling portion to a narrower end, where the support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve, and a central channel extending through the coupling portion and the support portion. The alignment device can include one or more axially extending alignment members, each alignment member extending axially outward from the first end of the coupling portion and over the support portion, each alignment member comprising a free end with a retention feature that is configured to hold the prosthetic heart valve in a specified orientation on the support surface.

Description

ALIGNMENT DEVICE FOR A PROSTHETIC IMPLANT CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 668,436, filed July 8, 2024, which is incorporated by reference herein in its entirety. FIELD

[0002] The present disclosure relates to apparatuses, systems, and methods for crimping a prosthetic implant onto a delivery apparatus. BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic 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] Mounting and crimping a prosthetic heart valve on a delivery apparatus involves complex steps and requires specialized skills. Accordingly, improvements to systems and methods to facilitate such mounting and crimping operations are desirable. SUMMARY

[0005] Described herein are alignment devices, assemblies, and methods for aligning a prosthetic heart valve in a desired circumferential and / or axial orientation within a crimpingdevice and crimping the prosthetic heart valve onto a delivery apparatus in a desired orientation. In some examples, an alignment device can comprise alignment members configured to hold the prosthetic heart valve in a desired circumferential and axial position on a support surface of the alignment device. As such, when a coupling portion of the alignment device is coupled to a crimping device, the prosthetic heart valve can be held within the crimping device in a desired circumferential and axial position relative to a delivery apparatus inserted into the crimping device, thereby making the crimping process more accurate and efficient.

[0006] The prosthetic heart valves delivered with the delivery apparatuses disclosed herein are, for example, radially expandable from a radially compressed state mounted on the delivery apparatus to a radially expanded state for implantation using an inflatable balloon (or an equivalent expansion device) of the delivery apparatus. Although the devices and methods disclosed herein are particularly described with respect to crimping and implanting prosthetic heart valves (for example, a prosthetic aortic valve or prosthetic mitral valve), the disclosed devices and methods can be used for crimping and implanting other types of prosthetic valves (for example, prosthetic venous valves) and / or other types of expandable prosthetic devices adapted to be implanted in various body lumens (for example, stents, grafts, etc.).

[0007] An alignment device for a prosthetic valve can comprise a coupling portion and a support portion that tapers from a wider end that is disposed adjacent a first end of the coupling portion to a narrower end, wherein the support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve thereon.

[0008] In some examples, the coupling portion of the alignment device can comprise a coupling member configured to couple with a crimping device.

[0009] In some examples, the alignment device can comprise a central channel extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

[0010] In some examples, the alignment device can comprise one or more axially extending alignment members, each alignment member extending axially outward from the first end of the coupling portion and over the support portion.

[0011] In some examples, each alignment member can have a free end with a retention feature that is configured to hold the prosthetic heart valve in a specified orientation on the support surface when the prosthetic heart valve is arranged on the support surface.

[0012] In some examples, the retention feature is configured to receive and hook around a portion of a frame of the prosthetic heart valve.

[0013] In some examples, the support portion comprises one or more cut-outs in the support surface that extend through the support portion.

[0014] In some examples, each alignment member extends over a respective cut-out of the one or more cut-outs.

[0015] In some examples, the free end of each alignment member is deflectable radially inward, into a respective cut-out of the one or more cut-outs.

[0016] In some examples, an alignment device for a prosthetic heart valve comprises a coupling portion configured to couple with a crimping device, and a support portion that tapers from a wider end that is disposed adjacent a first end of the coupling portion to a narrower end, where the support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve thereon. The alignment device further comprises one or more axially extending alignment members, each alignment member extending axially outward from the first end of the coupling portion and over the support portion, each alignment member comprising a free end with a retention feature that is configured to hold the prosthetic heart valve in a specified orientation on the support surface when the prosthetic heart valve is arranged on the support surface. The alignment device further comprises a central channel extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

[0017] In some examples, an alignment device for a prosthetic heart valve comprises a coupling portion configured to couple with a crimping device and a support portion that tapers from a wider end that is disposed adjacent a first end of the coupling portion to a narrower end, where the support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve thereon and one or more cut-outs that extend through a wall of the support portion and from the first end of the coupling portion toward the narrower end of the support portion. The alignment device further comprises one or more axially extending alignment members, each alignment member extending axially outward from the first end of the coupling portion and along a respective cut-out of the one or more cut-outs, each alignment member comprising a free end with a retention feature that is configured to hook around a portion of a frame of the prosthetic heart valve that is axiallyaligned with a commissure of the prosthetic heart valve and hold the prosthetic heart valve in place on the support surface when the prosthetic heart valve is arranged on the support surface. The alignment device further comprises a central channel extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

[0018] In some examples, an alignment device for a prosthetic heart valve comprises a coupling portion configured to couple with a crimping device and having opposing first and second ends and a support portion having opposing first and second ends and extending axially from the second end of the coupling portion, wherein the support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve thereon and a plurality of cut-outs in the support surface that extend through a wall of the support portion and extend from the first end of the support portion that is disposed adjacent to the second end of the coupling portion toward the second end of the support portion that is disposed axially away from the coupling portion. The plurality of cut-outs are spaced circumferentially apart around the support portion. The alignment device further comprises a plurality of axially extending alignment members, each alignment member extending axially outward from the second end of the coupling portion and along a respective cut-out of the plurality of cut-outs, each alignment member comprising a free end with a retention feature that is configured to receive a portion of the prosthetic heart valve and hold the prosthetic heart valve in place on the support surface when the prosthetic heart valve is arranged on the support surface, and where the free end is deflectable radially inward, into the respective cut- out during crimping or the prosthetic heart valve with the crimping device. The alignment device further comprises a central channel extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

[0019] In some examples, an alignment device for a prosthetic heart valve comprises a coupling portion comprising a coupling member configured to couple with a crimping device and a support portion that tapers from a wider end that is disposed adjacent a first end of the coupling portion to a narrower end. The support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve thereon, and the support portion includes a plurality of apertures spaced circumferentially apart around the support portion, each aperture extending through a wall of the support portion. Thealignment device further comprises one or more axially extending alignment members, each alignment member extending axially outward from the first end of the coupling portion, over the support portion and to the support surface, each alignment member comprising a free end configured to abut an end of the prosthetic heart valve and be axially aligned with a commissure of the prosthetic heart valve when the prosthetic heart valve is arranged on the support surface. The plurality of apertures and the free end of each alignment member are spaced circumferentially apart at a same axial location along the support portion. The alignment device further comprises a central channel extending through the coupling portion and the support portion, in a direction of a central longitudinal axis of the alignment device, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

[0020] In some examples, an alignment device for a prosthetic heart valve comprises a coupling portion configured to couple with a crimping device and a support portion having a wider end that is disposed adjacent a first end of the coupling portion and a narrower end spaced away from the coupling portion. The support portion comprises a first section that tapers radially inward from the wider end toward the narrower end at a first angle, a second section that tapers radially inward from the first section to the narrower end at a second angle, wherein the first angle is smaller than the second angle, and a central channel extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

[0021] In some examples, an alignment device for a prosthetic heart valve comprises a coupling portion comprising a coupling member configured to couple with a crimping device and a support portion that tapers from a wider end that is disposed adjacent a first end of the coupling portion to a narrower end. The support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve thereon, and the support portion includes a plurality of cut-outs spaced apart around the support portion, each cut-out extending through a wall of the support portion and along an entire length of the support portion from the wider end to the narrower end. The alignment device further comprises one or more axially extending alignment members, each alignment member extending axially outward from the first end of the coupling portion, over a respective cut-out of the plurality of cut-outs of the support portion and to the support surface, each alignment member comprising a free end configured to be axially aligned with a commissure of theprosthetic heart valve when the prosthetic heart valve is arranged on the support surface. The alignment device further comprises a central channel extending through the coupling portion and the support portion, in a direction of a central longitudinal axis of the alignment device, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

[0022] In some examples, an alignment device for a prosthetic heart valve comprises a coupling portion configured to couple with a crimping device; a support portion that tapers from a wider end that is disposed adjacent a first end of the coupling portion to a narrower end, wherein the support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve thereon and one or more cut-outs that extend through a wall of the support portion and from the first end of the coupling portion toward the narrower end of the support portion, wherein each cut-out comprises a first section with a first width and a second section with a second width that is smaller than the first width; one or more axially extending alignment members, each alignment member extending axially outward from the first end of the coupling portion and along a respective cut-out of the one or more cut-outs, each alignment member comprising a free end that is configured to interface with a frame of the prosthetic heart valve that is axially aligned with a commissure of the prosthetic heart valve when the prosthetic vale is arranged on the support surface; and a central channel extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

[0023] In some examples, an alignment device comprises one or more of the components recited in Examples 1-68 and 78-93 below.

[0024] A method can comprise placing a prosthetic valve in a radially expanded configuration over a support surface of a tapered support portion of an alignment device and rotationally aligning the prosthetic valve on the support surface and coupling a retention feature at a free end of each alignment member to the prosthetic valve to hold the prosthetic valve in place on the support surface.

[0025] In some examples, the method can comprise rotationally aligning the prosthetic valve on the support surface such that commissures of the prosthetic valve are axially aligned with alignment members of the alignment device.

[0026] In some examples, the support portion extends from a proximal end of a coupling portion of the alignment device, the alignment members extend axially outward from the proximal end of the coupling portion, and the coupling portion includes a coupling member.

[0027] In some examples, the method can comprise inserting the prosthetic valve held on the support surface into a channel of a crimping device, the channel being surrounded by a plurality of pressing surfaces of the crimping device.

[0028] In some examples, the method can comprise coupling the coupling member with the crimping device such that the alignment device is held in a specified circumferential orientation relative to the crimping device.

[0029] In some examples, the method can comprise radially compressing the prosthetic valve placed within the channel by actuating the crimping device to move the pressing surfaces radially inwardly.

[0030] In some examples, the method can comprise deflecting the alignment members radially inward and disengaging them from the prosthetic valve.

[0031] In some examples, a method comprises placing a prosthetic valve in a radially expanded configuration over a support surface of a tapered support portion of an alignment device and rotationally aligning the prosthetic valve on the support surface such that commissures of the prosthetic valve are axially aligned with alignment members of the alignment device, and coupling a retention feature at a free end of each alignment member to the prosthetic valve to hold the prosthetic valve in place on the support surface. The support portion extends from a proximal end of a coupling portion of the alignment device, the alignment members extend axially outward from the proximal end of the coupling portion, and the coupling portion includes a coupling member. The method further includes inserting the prosthetic valve held on the support surface into a channel of a crimping device, the channel being surrounded by a plurality of pressing surfaces of the crimping device. The method further includes coupling the coupling member with the crimping device such that the alignment device is held in a specified circumferential orientation relative to the crimping device. The method further includes radially compressing the prosthetic valve placed within the channel by actuating the crimping device to move the pressing surfaces radially inwardly. The radially compressing causes the alignment members to deflect radially inward and disengage from the prosthetic valve and causes the alignment device to be moved axially out of and away from the prosthetic valve.

[0032] In some examples, a method comprises one or more of the features recited in Examples 69-77 below.

[0033] 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

[0034] FIG.1 is a perspective view of a prosthetic heart valve.

[0035] FIG.2 is a perspective view of a delivery apparatus for a prosthetic heart valve, according to an example.

[0036] FIG.3 is a perspective view of a prosthetic heart valve, according to an example.

[0037] FIG.4 is a perspective view of a prosthetic heart valve, according to an example.

[0038] FIG.5A is a rear perspective view of an exemplary crimping device used to crimp a prosthetic device, such as a prosthetic heart valve, to a delivery apparatus.

[0039] FIG.5B is a front perspective view of the crimping device of FIG.5A.

[0040] FIG.6 is a perspective view of an exemplary alignment device comprising alignment members with retention features.

[0041] FIG.7 is a cross-sectional side view of the alignment device of FIG.6.

[0042] FIG.8 is a perspective view of the alignment device of FIG.6 with a frame of a prosthetic valve mounted on a support surface of the alignment device with the retention features of the alignment members coupled to a portion of the frame.

[0043] FIG.9 is a detail view of a portion of one alignment member of the alignment device of FIG.8 coupled to struts of the frame of the prosthetic valve.

[0044] FIG.10 is a side view of the alignment device of FIG.8.

[0045] FIG.11 is a perspective view of the alignment device of FIG.6 with a prosthetic valve mounted on a support surface of the alignment device with the retention features of the alignment members coupled to an end portion of the prosthetic valve.

[0046] FIG.12 is a cross-sectional view of an exemplary crimping device with the alignment device of FIG.6 coupled with the crimping device.

[0047] FIG.13 is a cross-sectional end view of the prosthetic valve mounted on the alignment device within a channel of the crimping device of FIG.12 and pressing surfaces of the crimping device interfacing with the alignment members of the alignment device during crimping.

[0048] FIG.14 is a schematic, cross-sectional side view of an exemplary alignment device comprising a support portion with a first section and second section that each taper at different angles relative to a central longitudinal axis of the alignment device.

[0049] FIG.15 is a schematic, cross-sectional side view of an exemplary alignment device comprising a support portion with a first section and second section that each taper at different angles relative to a central longitudinal axis of the alignment device, and a step arranged at an end of the first section that connects to a coupling portion of the alignment device.

[0050] FIG.16 is a schematic, cross-sectional side view of an exemplary alignment device comprising a support portion and alignment members extending over the support portion, where the support portion has a support surface including a plurality of apertures spaced circumferentially apart around the support surface, where the apertures are aligned with free ends of the alignment members.

[0051] FIG.17 is a schematic, cross-sectional side view of an exemplary alignment device comprising a support portion with axially extending slots that extend across an entire length of the support portion and alignment members that each extend over a respective axially extending slot.

[0052] FIG.18 is a simplified, schematic end view of the alignment device of FIG.17.

[0053] FIG.19 is a flow chart for radially compressing a prosthetic valve onto a delivery apparatus with a crimping device while the prosthetic valve is held in a predetermined circumferential orientation and axial position within and relative to the crimping device.

[0054] FIG.20 is a perspective view of an exemplary alignment device comprising alignment members with retention features and cut-outs shaped to receive the alignment members. DETAILED DESCRIPTION General Considerations

[0055] 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 disclosureis 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.

[0056] 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.

[0057] 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.

[0058] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0059] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Overview of the Disclosed Technology

[0060] As introduced above, prosthetic heart valves can be mounted onto a delivery apparatus in a crimped or radially compressed state for delivery to a target implantation site using the delivery apparatus. However, mounting and crimping a prosthetic heart valve on a delivery apparatus involves complex steps and requires specialized skills. For example, it may be desirable to crimp the prosthetic heart valve onto a delivery apparatus in a specified circumferential orientation relative to the delivery apparatus (for example, with a commissure of the prosthetic heart valve being aligned with a radiopaque marker on the delivery apparatus). In some examples, it may be desirable to crimp the prosthetic heart valve onto the delivery apparatus in a specified axial orientation on the delivery apparatus (for example, on a valve mounting portion of the delivery apparatus). However, when crimping using a crimping device, the prosthetic valve may be inadvertently shifted axially or rotated from its specified alignment with the delivery apparatus inserted inside the crimping device. As a result, the prosthetic heart valve may not be crimped into the specified circumferential and / or axial orientation on the delivery apparatus. This can result in the prosthetic heart valve being implanted at the native anatomy in a position that is different than desired or creating more difficulty during the implantation procedure.

[0061] In some examples, an alignment device can be used to mount a prosthetic heart valve thereon prior to crimping the prosthetic heart valve to the delivery apparatus. The alignment device can be configured with one or more alignment members that are configured to be aligned with target features on the prosthetic heart valve (for example, one or more commissures of the prosthetic heart valve). As a result, the prosthetic heart valve can be aligned on the alignment device in a specified circumferential (or rotational) position relative to the alignment device. In some examples, the prosthetic heart valve may fit more loosely on a support surface of the alignment device, thereby causing it to possibly slide along or fall off the alignment device when being inserted into the crimping device. Thus, in some examples, the one or more alignment members can comprise a retention feature at their free end that is configured to hold the prosthetic valve on a support surface of the alignment device, thereby preventing the valve from shifting axially or circumferentially on the alignment device when being coupled with the crimping device.

[0062] In some examples, the retention features of the alignment members can attach, hook, or otherwise couple to a portion of the prosthetic heart valve (for example, the valve frame),thereby holding the valve in place (axially and / or circumferentially) on the alignment device. In some instances, the retention features on the alignment members can be particularly useful for retaining smaller diameter prosthetic valves, such as valves having a diameter of less than 23 mm or about 20 mm, on the alignment device.

[0063] The alignment device can also include a coupling member that is configured to couple with a crimping device. As a result, the alignment device can be coupled with the crimping device in a specified circumferential orientation relative to the crimping device, thereby aligning the prosthetic heart valve mounted and held thereon in a specified circumferential orientation with the crimping device. As a result, the prosthetic heart valve can be crimped onto a delivery apparatus using the crimping device in a desired circumferential and axial orientation relative to the delivery apparatus.

[0064] FIGS.1, 3, and 4 show exemplary prosthetic heart valves comprising a frame and a plurality of leaflets. FIG.2 depicts an exemplary delivery apparatus that may be used to deliver any of the prosthetic valves described herein to a target implantation site. FIGS.5A and 5B show an exemplary crimping device that can be used to crimp a prosthetic valve onto a delivery apparatus prior to an implantation procedure.

[0065] FIGS.6-11 depict an alignment device comprising alignment members with retention features that are configured to hold a prosthetic valve on a support surface of the alignment device (as shown in FIGS.8-11), thereby preventing unwanted axial or rotational movement of the valve on the support surface.

[0066] FIG.12 depicts the alignment device held within a crimping device with the prosthetic valve mounted thereon. During crimping, crimping jaws of the crimping device can press against and deflect the alignment members of the alignment device radially inward, thereby releasing the prosthetic valve and enabling the crimping device to crimp the prosthetic valve onto a delivery apparatus (as shown in FIG.13). FIG.19 presents a method for radially compressing a prosthetic valve onto a delivery apparatus with the crimping device while the prosthetic valve is held in a predetermined circumferential orientation and axial position within and relative to the crimping device using the alignment device.

[0067] FIGS.14-18 show examples of various alignment devices with sloped support surfaces and / or apertures that are configured to retain a prosthetic valve on the support surface (such as a smaller diameter prosthetic valve) before and during crimping.

[0068] FIG.20 shows an example of an alignment device with windows or cut-outs that are each shaped to receive a respective alignment member. Each cut-out can comprise a wider section and a narrower section that is configured to increase leaflet contact area on the alignment device and enable better ejection of the alignment device from the crimping device during crimping. Examples of the Disclosed Technology

[0069] FIG.1 shows an exemplary prosthetic valve 10, according to one example. 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.

[0070] 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 some examples, 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 some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No.2019 / 0000615, which is incorporated herein by reference.

[0071] The prosthetic valve 10 comprises four main components: a stent or frame 12, a valvular structure 14, an inner skirt 16, and a perivalvular outer sealing member or outer skirt 18. The prosthetic valve 10 can have an inflow end portion 15 (also referred to herein as an “inflow end”), an intermediate portion 17, and an outflow end portion 19. The inner skirt 16can be arranged on and / or coupled to an inner surface of the frame 12, while the outer skirt 18 can be arranged on and / or coupled to an outer surface of the frame 12.

[0072] The valvular structure 14 can comprise three leaflets 40, collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, although in some instances there can be greater or fewer number of leaflets (for example, one or more leaflets 40). The leaflets 40 can be secured to one another at their adjacent sides to form commissures 22 of the valvular (for example, leaflet) structure 14. The lower edge of valvular structure 14 can have an undulating, curved scalloped shape and can be secured to the inner skirt 16 by sutures (not shown). In some examples, the leaflets 40 can be formed of pericardial tissue (for example, bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in U.S. Patent No.6,730,118, which is incorporated by reference herein.

[0073] The frame 12 can be formed with a plurality of circumferentially spaced slots, or commissure windows 20 that are adapted to mount the commissures 22 of the valvular structure 14 to the frame. For example, the commissure windows 20 can be defined by axially extending window strut portions 24 (relative to a central longitudinal axis 50 of the prosthetic valve 10) of the frame 12, which can also be referred to herein as “commissure supports”. Each commissure window 20 is adapted to receive a pair of commissure tabs 42 of a pair of adjacent leaflets 40 arranged into a corresponding commissure 22. As shown in FIG.1 and described further below, the pair of commissure tabs 42 extend from inside the frame 12, through the commissure window 20, and exterior to the frame 12. For example, as shown in FIG.1, the commissure tabs 42 can extend over and / or protrude radially outward from an outer surface 44 (radially outward facing surface) of the frame 12, and in particular, outer surfaces of the window strut portions 24.

[0074] The frame 12 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol). When constructed of a plastically-expandable material, the frame 12 (and thus the prosthetic valve 10) can be crimped to a radially collapsed configuration on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 12 (and thus the prosthetic valve 10) 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 catheter. Once inside thebody, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

[0075] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 12) 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 12 can comprise stainless steel. In some examples, the frame 12 can comprise cobalt- chromium. In some examples, the frame 12 can comprise nickel-cobalt-chromium. In some examples, the frame^12 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.

[0076] FIG.2 shows a delivery apparatus 100, according to an example, that can be used to implant an expandable prosthetic heart valve (for example, prosthetic valve 10), or another type of expandable prosthetic medical device (such as a stent). In some examples, the delivery apparatus 100 is specifically adapted for use in introducing a prosthetic valve into a heart.

[0077] The delivery apparatus 100 in the illustrated example of FIG.2 is a balloon catheter comprising a handle 102, a steerable, outer shaft 104 extending from the handle 102, an intermediate shaft extending from the handle 102 coaxially through the steerable outer shaft 104, and an inner shaft 106 extending from the handle 102 coaxially through the intermediate shaft and the steerable, outer shaft 104, an inflatable balloon (for example, balloon) 108 extending from a distal end of the intermediate shaft, and a nosecone 110 arranged at a distal end of the delivery apparatus 100. A distal end portion 112 of the delivery apparatus 100 includes the balloon 108, the nosecone 110, and a balloon shoulder assembly. A prosthetic medical device, such as a prosthetic heart valve may be mounted on a valve retaining portion of the balloon 108, or adjacent to the balloon 108.

[0078] In some examples, a balloon shoulder assembly is configured to maintain the prosthetic heart valve or other medical device at a fixed position on the balloon 108 during delivery through the patient’s vasculature. In some examples, the balloon shoulder assembly can include a proximal shoulder 120 and / or a distal shoulder 122.

[0079] The balloon 108 can include a central portion (which can be approximately cylindrical when inflated, as shown in FIG.2) and two tapered end portions that connect to the delivery apparatus 100 (for example, to one or more shafts and / or a nosecone of the delivery apparatus).

[0080] The handle 102 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus. In the illustrated example, for example, the handle 102 includes an adjustment member, such as the illustrated rotatable knob 134, which in turn is operatively coupled to the proximal end portion of a pull wire (not shown). The pull wire extends distally from the handle 102 through the outer shaft 104 and has a distal end portion affixed to the outer shaft at or near the distal end of the outer shaft 104. Rotating the knob 134 is effective to increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus.

[0081] The delivery apparatus 100 can be configured to be advanced over a guidewire that can be received within a guidewire lumen defined by an innermost shaft of the delivery apparatus 100.

[0082] In some examples, the delivery apparatus (or another, similar delivery apparatus) can be configured to deploy and implant a prosthetic heart valve (for example, prosthetic valve 10 of FIG.1) in the native aortic annulus of a native aortic valve. Further details on such a delivery apparatus can be found in International Application No. PCT / US2021 / 047056, which is incorporated by reference herein.

[0083] FIG.3 shows a prosthetic valve 200 comprising a radially expandable and / or compressible annular frame 202, a plurality of leaflets 204 mounted within the frame 202, and an outer skirt 206 secured to and around an outer surface of the frame 202. The frame 202 can comprise a plurality of interconnected struts 214 and a plurality of apices 208 that are spaced circumferentially apart around an inflow end 216 and an outflow end 218 of the frame 202 (only the apices 208 at the outflow end portion 218 are visible in FIG.3). Each apex 208 is formed at a junction between two angled struts 214 at either the inflow end 216 or the outflow end 218. The frame 202 comprises a plurality of axially extending posts 210, some of which define commissure windows therein. For example, the axially extending posts 210 that define commissure windows therein can comprise axially extending window struts 220 (which can also be referred to herein as commissure supports or commissure support posts) that define a commissure window 222 therebetween. Commissure tabs of adjacent leaflets204 can be paired together and extend through the commissure windows 222, thereby forming commissures 212 secured to the frame 202 which can protrude radially outward from the frame 202. In some examples, the prosthetic valve 200 can be a balloon expandable valve and can be used with the delivery apparatus 100 of FIG.2. Additional details on the prosthetic valve 200 can be found in PCT Publication No. WO / 2022 / 226147, which is incorporated by reference herein.

[0084] FIG.4 shows a prosthetic valve 250 comprising a stent or frame, 252, a valvular structure 254, and a sealing member 256. The prosthetic valve 250 has an inflow end 266 and an outflow end 268. The valvular structure 254 can comprise three leaflets 260, 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 (for example, one or more leaflets 260). Each leaflet 260 can be coupled to the frame 252 along its inflow edge (also referred to as “cusp edge”) and at commissures 264 of the valvular structure 254 where adjacent portions (for example, commissure tabs) of two leaflets are connected to each other. In some examples, the commissures 264 can comprise an attachment member (for example, comprising fabric, flexible polymer, or the like) arranged across a cell (for example, commissure cell) of the frame 252, 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 264.

[0085] 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.

[0086] The frame 252 in the illustrated example comprises a plurality of circumferentially extending rows of angled struts 272 defining rows of open cells (or openings) of the frame. The frame 252, at each of the inflow end 266 and the outflow end 268, may comprise a plurality of apices 280 spaced apart from one another around a circumference of the frame 252.

[0087] The sealing member 256 in the illustrated example is mounted on the outside of the frame 252 and functions to create a seal against the surrounding tissue (for example, the native leaflets and / or native annulus) to prevent or at least minimize paravalvular leakage. In some examples, the sealing member 256 can comprise an inner layer 276 (which can be incontact with the outer surface of the frame 252) and an outer layer 278. The sealing member 256 can be connected to the frame 252 using suitable techniques or mechanisms. For example, the sealing member 256 can be sutured to the frame 252 via sutures that can extend around the struts 272 and through the inner layer 276. In alternative examples, the inner layer 276 can be mounted on the inner surface of the frame 252, while the outer layer 278 is on the outside of the frame 252.

[0088] Additional details regarding the prosthetic valve 250 and its various components are described in U.S. Patent Publication No.2018 / 0028310, which is incorporated by reference herein in its entirety.

[0089] According to some examples, to implant a prosthetic valve (for example, prosthetic valves 10, 200, or 250) 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 distal end portion 112 of the delivery apparatus 100.

[0090] In some instances, once inside the patient’s vasculature, the position (for example, axial position) of the prosthetic valve relative to the balloon 108 can be adjusted such that the prosthetic valve is centered on the balloon 108.

[0091] In some instances, the axial position of the prosthetic valve relative to the balloon 108 may not be adjusted.

[0092] When navigating the prosthetic valve through an arched region of the vasculature (for example, the aortic arch), the curvature of the distal end portion of the delivery apparatus 100 can be adjusted, for example, by rotating the knob 134 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 108, the outer shaft 104 can be retracted proximally away from the balloon 108 for a sufficient distance so that the outer shaft does not interfere with balloon inflation. Then, the prosthetic valve can be radially expanded and deployed by inflating the balloon 108. Inflation of the balloon 108 can radially expand the prosthetic valve so that the prosthetic valve contacts the native annulus. The expanded prosthetic valve becomes anchored within the native aortic annulus by the radial outward force of the valve’s frame against the surrounding tissue.

[0093] In some examples, a knob of the delivery apparatus 100, or the entire delivery apparatus, can be configured to rotate the intermediate shaft of the delivery apparatus 100, thereby rotating the balloon 108 mounted on the intermediate shaft and a radially compressed prosthetic valve mounted on the balloon 108. As a result, the prosthetic valve can be rotated around a central longitudinal axis of the delivery apparatus, into a desired (circumferential or rotational) orientation relative to the native anatomy at the target implantation site.

[0094] For example, to implant a prosthetic valve 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, which may result in commissures of the prosthetic valve being arranged in front of the coronary arteries, it may be desirable to deploy the prosthetic valve in a targeted rotational orientation where the commissures are positioned away from and do not block the coronary arteries (for example, to reduce the likelihood 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 relative to the native valve, to achieve the commissure alignment, thereby increasing access to the coronary arteries. Additionally, this positioning of the prosthetic heart valve can facilitate a later, leaflet cutting procedure that provides increased access to the coronary arteries.

[0095] Further details on methods of aligning commissures of native valve with commissures of prosthetic valve after deploying the prosthetic valve are described in PCT Patent Publication No. WO 2022 / 046585, which is incorporated by reference herein in its entirety.

[0096] FIGS.5A-18 show examples of various components that can be used to crimp a prosthetic valve (such as prosthetic valve 50, 200, or 250) onto a valve mounting portion of a delivery apparatus (for example, either on or proximal to the inflatable balloon, such as balloon 108) in a predetermined position and orientation relative to the delivery apparatus. For example, it may be desirable to crimp the prosthetic heart valve onto the delivery apparatus in a specified circumferential orientation relative to the delivery apparatus, such as a commissure of the prosthetic heart valve being circumferentially aligned with a radiopaque marker on the delivery apparatus (for example, a radiopaque marker that is distal to the inflatable balloon).

[0097] The prosthetic valve may be crimped to the valve mounting portion of the delivery apparatus in a variety of manners. In some examples, a crimping device, such as theexemplary crimping device 300 shown in FIGS.5A and 5B, can be used to crimp the prosthetic valve onto the valve mounting portion of the delivery apparatus. As described further below, the crimping device 300 can include mating interfaces, on opposite sides of the crimping device 300, that are configured to receive and mate with corresponding mating interfaces on first and second components of the mounting assembly.

[0098] FIG.5A illustrates a rear perspective view of the crimping device 300 (or a view from the proximal side of the crimping device 300) and FIG.5B illustrates a front perspective view of the crimping device 300 (or a view from the distal side of the crimping device 300). The crimping device 300 can include a base 386, an actuator in the form of a handle 388, and a channel 390 for the prosthetic valve and the delivery apparatus to be inserted into. The crimping device 300 may include a proximal face 392 including a proximal opening 394 that leads into the channel 390. The proximal opening 394 may be configured for the delivery apparatus to be inserted into the channel 390 therethrough.

[0099] In some examples, the proximal face 392 can include a mating interface with mating structures 396 in the form of cut-outs that can be configured to mate with a positioning device (for example, a positioning device coupled to a distal end portion of delivery apparatus, as disclosed in PCT Patent Publication No. WO 2022 / 046585, which is already incorporated by reference above). For example, the mating interface can include one or more mating structures 396.

[0100] The crimping device 300 can further include a rotatable body 398 configured to be rotated with rotation of the handle 388. The crimping device 300 may operate by a plurality of pressing surfaces 384 surrounding the channel 390 and being configured to apply a compressive force to radially compress a prosthetic valve positioned within the channel 390 (for example, prosthetic valve 50, 200, or 250). The pressing surfaces 384 may surround an axis 302 of the channel 390. The pressing surfaces 384 may be configured such that as the rotatable body 398 is rotated, a body presses and moves the pressing surfaces 384 towards the center of the channel 390 and the diameter of the channel 390 reduces. The pressing surfaces 384 may form an iris structure that allows the pressing surfaces 384 to move towards the center of the channel 390 and reduce the diameter of the channel 390. A prosthetic valve positioned within the channel 390 will accordingly be compressed within the channel 390, due to the radially compressive force of the pressing surfaces 384 against the prosthetic valve.

[0101] As shown in FIG.5B, the crimping device 300 may include a distal face 304 including a distal opening 306 that leads into the channel 390. The distal face 304 can include a mating interface, which can comprise a cut-out portion 308. In some examples, the cut-out portion 308 can be configured as (and referred to as) a recess, notch, indentation, depression, cut-out, or the like, in the distal face 304. The cut-out portion 308 (or recess 308) can be configured (for example, shaped) to receive an alignment device of a valve support member for the prosthetic valve (for example, the coupling member 422 shown in FIGS.6- 12, as described further below).

[0102] The distal opening 306 can be configured for a portion of the delivery apparatus to pass therethrough during a crimping operation being performed by the crimping device 300.

[0103] The configuration of a crimping device can be varied in alternate examples.

[0104] 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), an alignment device can be used. A first portion of the alignment device can be configured to receive the prosthetic valve (for example, prosthetic valve 50, 200, or 250) thereon and a second portion of the alignment device can couple to a crimping device (for example, crimping device 300). For example, the alignment device can include one or more alignment members that are configured to be aligned with target features on the prosthetic valve (for example, one or more commissures of the prosthetic heart valve). As a result, the prosthetic valve can be aligned on the first portion of the alignment device in a specified circumferential (or rotational) position relative to the alignment device. When the second portion of the alignment device is coupled to the crimping device, the prosthetic valve is held within the crimping device in a specified circumferential orientation and / or axial orientation relative to the 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 (for example, 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.

[0105] 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, thefirst portion (a valve support portion) of the alignment device 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.

[0106] As introduced above, in some examples, the prosthetic valve may fit more loosely on the first portion of the alignment device, thereby causing it to possibly slide along or fall off the alignment device when being inserted into the crimping device. Thus, in some examples, the alignment members can comprise retention features at their free end that are configured to hold the prosthetic valve on a support surface of the alignment device, thereby preventing the valve from shifting axially or circumferentially on the alignment device when being coupled with the crimping device. In some instances, the retention features on the alignment members can be particularly useful for retaining smaller diameter prosthetic valves, such as valves having a diameter of less than 23 mm or about 20 mm, on the alignment device.

[0107] FIGS.6-11 depict an exemplary alignment device 400 that is configured to receive a prosthetic valve thereon and couple to a crimping device. As shown in the perspective view of FIG.6 and the cross-sectional side view of FIG.7, the alignment device 400 includes a coupling portion 402, a support portion 404 (valve support portion), and one or more alignment members 406. The alignment device 400 also includes a central channel 408 extending through the coupling portion 402 and the support portion 404. The central channel 408 is configured to receive a delivery apparatus for the prosthetic valve therethrough (for example, delivery apparatus 100).

[0108] As described more fully below, the coupling portion 402 can be configured to releasably couple to a crimping device, such as the crimping device 300 shown in FIGS.5A- 5B and 12-13. The support portion 404 can be configured to be inserted into a prosthetic valve (for example, prosthetic valve 50, 200, or 250) so that leaflets of the prosthetic valve can contact and rest upon a support surface 410 of the support portion 404. The alignment members 406 can be used to space the prosthetic valve away from the coupling portion 402 and achieve a desired rotational and / or axial alignment of the prosthetic valve relative to the coupling portion 402 and the crimping device. As described further below, the alignment members 406 can be further configured to hold the prosthetic valve in place on the support surface 410 (in the desired rotational and / or axial configuration), so that the prosthetic valve cannot slip or be knocked off the alignment device 400.

[0109] As shown in FIGS.6-8, the support portion 404 can extend proximally from the coupling portion 402.

[0110] In some examples, the support portion 404 and the coupling portion 402 (and the alignment members 406) can be formed (e.g., molded together) as one piece (as a unitary component).

[0111] In some examples, the support portion 404 and the coupling portion 402 can be two separate pieces that are removably coupled to one another, such as described in U.S. Patent Application No.63 / 533,555, filed August 18, 2023, which is incorporated by reference herein, as already noted above.

[0112] As introduced above, the coupling portion 402 can be configured to be inserted into the channel 390 of the crimping device 300 (from one side or the distal face 304 of the crimping device 300) and couple to the crimping device 300.

[0113] The coupling portion 402 includes a first end 412 (which, in some examples, can be the distal end) and a second end 414 (which, in some examples, can be the proximal end).

[0114] The coupling portion 402 includes a cylindrical wall 416 (as shown in FIG.7), which has an outer surface 418 and an inner surface 420 (FIG.7). The inner surface 420 defines a lumen of the coupling portion 402 that forms a portion of the central channel 408. The cylindrical wall 416 extends between the first end 412 and the second end 414 of the coupling portion 402. In some examples, the first end 412 can be referred to as a first end of the cylindrical wall 416 and the second end 414 can be referred to as the second end of the cylindrical wall 416.

[0115] The coupling portion 402 includes a coupling member 422 (FIGS.6, 8, and 11) that is configured to rotationally align the coupling portion 402 with the crimping device (e.g., crimping device 300, as shown in FIG.12). The coupling member 422 can be circumferentially positioned on the coupling portion 402, proximate to the first end 412, such that it aligns the coupling portion 402 in a predetermined circumferential orientation within the channel 390 of the crimping device 300.

[0116] For example, the coupling member 422 can be configured (shaped) to mate with a cut-out portion of a crimping device (for example, cut-out portion 308, or recess 308, of the crimping device 300). In this manner, the coupling member 422 rotationally aligns the coupling portion 402, and thus the valve mounted on the support portion 404, with the crimping device. As a result of this coupling between the coupling member 422 and cut-outportion 308, the alignment device 400, and prosthetic valve mounted thereon, are prevented from rotating during crimping using the crimping device 300 (or another, similar crimping device).

[0117] In some examples, as shown in FIGS.6, 8, and 11, the coupling member 422 is an axially extending projection that extends axially away from the first end 412 toward the second end 414 of the coupling portion 402.

[0118] In some examples, as shown in FIGS.6, 8, and 11, a free end 424 of the coupling member 422 tapers at both a top (radially outward facing side) and bottom (radially inward facing side) to a point 426.

[0119] In some examples, instead of tapering to a point 426, the free end 424 can taper to a narrower region (e.g., that is a little wider than shown in FIG.6 and can be referred to as a tapered end). By having a taper on both sides of the free end 424 of the coupling member 422, the alignment device 400 can be easier to manufacture.

[0120] In some instances, the free end 424 may only taper on one side of the coupling member 422 (e.g., only from the top or radially outward facing side to the point).

[0121] The tapered free end 424 can allow for easier insertion into and coupling with the cut- out portion (for example, cut-out portion 308) in the crimping device.

[0122] In some examples, an attached end 428 of the coupling member 422 (which is opposite the free end 424) can extend or protrude outward from a base element 430 of the coupling portion 402. The base element 430 can extend axially from the first end 412 and extend radially outward, away from the outer surface 418 of the cylindrical wall 416. As a result, the coupling member 422 can be spaced radially away and outward from the outer surface 418 of the cylindrical wall 416.

[0123] In some examples, as shown in FIG.12, when the coupling member 422 is inserted into and coupled with the cut-out portion 308 of the crimping device 300, the base element 430 can be disposed adjacent and / or against the distal face 304 of the crimping device 300 (outside the channel 390).

[0124] In some examples, the coupling member 422 can have different configurations, such as a recess, snap-in feature, or alternate alignment feature that is configured to mate with a corresponding mating interface of the crimping device 300 (or another crimping device). As one example, the crimping device can comprise a projection (in lieu of the cut-out portion308) and the coupling member can comprise a slot (in lieu of the projection 422) configured to receive the projection of the crimping device.

[0125] Returning to FIG.6, the cylindrical wall 416 of the coupling portion 402 can include one or more retaining members 432 which can be configured as axial locking mechanisms that prevent the coupling portion 402 from moving axially relative to the crimping device after the alignment device 400 is inserted into and couples to the crimping device. As a result, the alignment device 400 can be retained in a predetermined axial position within the crimping device, and relative to a delivery apparatus inserted into and coupled with the crimping device.

[0126] In some examples, the coupling portion 402 includes two retaining members 432 spaced 140-180 degrees apart from one another around the coupling portion 402.

[0127] However, in some examples, the coupling portion 402 can include more or less than two retaining members 432 (e.g., one, three, or the like).

[0128] Each retaining member 432 can comprise a finger with a free end 434 and an attached end 436 that are formed by a U-shaped slot 433 in (or through) the cylindrical wall 416. The free end 434 includes a protrusion 438 (or nub or bump) that protrudes radially outward from an outer surface of the free end 434.

[0129] The retaining member 432 can be configured as a cantilever, where the free end 434 deflects radially inward as the coupling portion 402 is slid into the channel 390 of the crimping device and then deflects radially outward with the protrusion 438 snapping into a complementary-shaped pocket or slot in the crimping device. Further details on such a complementary-shaped pocket or slot in a crimping device that is configured to receive the retaining member of an alignment device, along with further details on interfaces between a crimping device and alignment device, is described in U.S. Patent Application No. 63 / 533,555, filed August 18, 2023, which is incorporated by reference herein in its entirety.

[0130] A length of the retaining member 432 and size (e.g., radius or height) of the protrusion 438 can be specified such that the free end 434 easily snaps into the slot in the crimping device with little force (from the user) but is also easily released as the crimping device is actuated (to radially compress or crimp the prosthetic valve).

[0131] In some instances, the protrusion 438 can be a spherical nub with a radius that is specified to allow easy insertion and locking into the predetermined axial position within thecrimping device and also easy release from the crimping device (such that the alignment device 400 can be removed) upon crimping with the crimping device.

[0132] In some examples, as shown in FIGS.6, 8, and 11, the alignment device 400 can include a visual indicator 440 that enables a user to easily identify the type of alignment device 400 being used. In some examples, the visual indicator 440 is disposed in the outer surface 418 of the cylindrical wall 416 and can comprise letters or numbers (“##” is shown for illustration purposes only) that correspond to the type of alignment device 400 (such as a specified size out of several possible sizes, which may correspond to a size or type of prosthetic valve to be mounted onto the support portion 404).

[0133] In some examples, as shown in FIG.10, the cylindrical wall 416 can include a flat indentation 490 that is depressed into the outer surface 418 toward the inner surface 420. The indentation 490 can be the location of the molding gate for injection molding the alignment device 400.

[0134] In some examples, the cylindrical wall 416 may not include the indentation 490.

[0135] As introduced above, the support portion 404 can be configured to rotationally align the prosthetic valve on a support surface 410 of the support portion 404, be inserted into a channel of a crimping device (for example, the channel 290 of the crimping device 300), and receive a delivery apparatus through the central channel 408.

[0136] The support portion 404 includes a first end 442 (which, in some examples, can be a distal end) and second end 444 (which, in some examples, can be a proximal end). The first end 442 is disposed adjacent to the second end 414 of the coupling portion 402.

[0137] In some examples, as shown in FIGS.6 and 7, the first end 442 is directly attached to or continuous with the second end 414 of the coupling portion 402.

[0138] In some examples, the first end 442 of the support portion 404 can be attached to an axial wall 446 of the coupling portion 402. The axial wall 446 can be arranged normal to a central longitudinal axis 401 of the alignment device 400 and perpendicular to the cylindrical wall 416.

[0139] The support portion 404 tapers from the first end 442 to the second end 444, such that the second end 444 is narrower (in diameter) than the first end 442. As a result, the support surface 410 which is configured to receive the prosthetic heart valve thereon, also tapers in diameter. In this way, the support surface 410 can be referred to as a conical support surface.

[0140] In some examples, the support surface 410 extends from the first end 442 to the second end 444 of the support portion 404.

[0141] The alignment device 400 includes one or more axially extending alignment members 406 spaced circumferentially apart from one another around the alignment device 400. In some examples, the alignment device 400 includes three alignment members 406 (one for each commissure of the prosthetic valve).

[0142] In some examples, the alignment device 400 can include more or less than three alignment members 406 (e.g., one, two, or the like).

[0143] As shown in FIGS.6-8 and 10, each alignment member 406 includes an attached end 448 and a free end 450 disposed axially away from the attached end 448. The attached end 448 is disposed at (coupled to or formed together with) the second end 414 of the coupling portion 402.

[0144] As such, each alignment member 406 can be configured as a cantilever where the free end 450 is configured to deflect and bend in the radial direction relative to the attached end 448.

[0145] In some examples, the attached end 448 is disposed at (or formed with) the axial wall 446 of the coupling portion 402. Each alignment member 406 extends axially outward from the axial wall 446, over a portion of the support portion 404.

[0146] The support portion 404 can include one or more windows or cut-outs 452 in the support surface 410 that extend through at least a portion of the support portion 404. Each alignment member 406 extends over a respective cut-out 452 of the one or more cut-outs 452.

[0147] The support portion 404 can have one cut-out 452 for each alignment member 406 (e.g., three cut-outs 452 in the example shown in FIGS.6-11). As such, each cut-out 452 can be configured to receive the free end 450 of a respective alignment member 406 therein.

[0148] In some examples, the cut-outs 452 are spaced circumferentially apart around the support portion 404 with the support surface 410 extending between adjacent cut-outs 452.

[0149] Each cut-out 452 can extend through a wall of the support portion 404, from the support surface 410 to the central channel 408. For example, each cut-out 452 can extend through an entire thickness of the support portion 404, between the outer support surface 410 and an inner surface 456 of the support portion 404 that defines a portion of the central channel 408.

[0150] Each cut-out 452 can have a width (in the circumferential direction) that is at least as wide as, or wider than, the corresponding alignment member 406.

[0151] The free end 450 of each alignment member 406 is configured to deflect or bend radially inward, into the corresponding cut-out 452, in response to a radially inward directed force applied to its outer surface (e.g., during crimping with a crimping device).

[0152] As shown in FIGS.6-8 and 10, in some examples, each cut-out 452 is disposed adjacent to the first end 442 of the support portion 404. For example, each cut-out 452 can extend from the first end 442 toward, but spaced away from, the second end 444 of the support portion 404.

[0153] The length of the cut-outs, as defined between the first end 442 and toward the second end 444 of the support portion 404, are longer than their respective alignment members 406.

[0154] The free end 450 of each alignment member 406 can include a retention feature 454 that is configured to hold the prosthetic heart valve on the support surface 410 when the prosthetic heart valve is arranged on the support surface 410 (as shown in FIGS.8-11).

[0155] Each retention feature 454 is shaped to hook around a portion of a frame of the prosthetic heart valve. In FIGS.8-11, frame 12 of prosthetic valve 10 is shown coupled to the alignment device 400 by way of example. However, the retention features 454 (and the entire alignment device 400) can be adapted (shaped and / or sized) to hook around a variety of prosthetic valve frames, such as any of the frames described herein. It should be noted that only the frame 12 of the prosthetic valve is shown in FIGS.8-10 for ease of illustration. However, it should be understood that the entire prosthetic valve including leaflets and, in some examples, a skirt, can be retained on the alignment device 400 by the retention features 454, as shown in FIG.11.

[0156] For example, as shown in FIGS.8-11 and seen in greater detail in FIG.9, each retention feature 454 can be shaped as a hook (or hook-like) which defines an indented region 458, a protrusion 460 disposed on a first side of the indented region 458, and a stop element 462 disposed on an opposite, second side of the indented region 458. The protrusion 460 is closer to a tip of the free end 450 than the stop element 462 and the stop element 462 is closer to the attached end 448 of the alignment member 406 than the protrusion 460.

[0157] The stop element 462 can include a wall extending perpendicular to the length of the alignment member 406 that extends between the attached end 448 and the free end 450. A remainder, or leg 464, of the alignment member 406 extends from the stop element 462 to theattached end 448. In some examples, a first portion of the leg 464 closer to and extending to the stop element 462 is wider than a second portion of the leg 464 that includes and extends from the attached end 448.

[0158] The indented region 458 indents radially inward from the leg 464, as shown in FIG.7. The protrusion 460 protrudes radially outward from the indented region 458 and a tip of the free end 450 that is on an opposite side of the protrusion 460 from the indented region 458.

[0159] In some examples, as shown in FIGS.7 and 9, the protrusion 460 can include a rounded tip that is configured to interface with pressing surfaces of a crimping device (for example, as shown in FIG.13, described further below). The protrusion 460 can gradually slope from the indented region 458 (creating a ramp, for example) and the tip of the free end 450.

[0160] In some examples, a radially inward facing side of the free end 450 that is opposite the protrusion 460 is relatively planar (as shown in FIG.7).

[0161] As shown in FIGS.8-11, the indented region 458 is configured to receive a strut (or struts) of the frame 12 of the prosthetic heart valve. In some examples, as shown in FIG.9, the indented region 458 receives an apex 30 of the frame 12 joining two struts 32 at an end of the frame 12. In some examples, the end is the inflow end 15 of the frame 12. In some examples, the end is the outflow end 19 of the frame 12.

[0162] In some examples, the apex 30 of the frame 12 can abut the stop element 462, as shown in FIG.9. As a result, the frame 12 is held in a specified axial orientation on the support surface 410 (for example, the apex 40 cannot move past the stop element 462 on the support surface 410).

[0163] The protrusion 460 can extend into an open cell 34 of the frame 12, thereby preventing the frame 12 from shifting axially and circumferentially on the support surface 410. In this way, the retention features 454 can hold the frame 12 (and prosthetic valve) in a specified axial and / or circumferential position on the support surface 410 and prevent the prosthetic valve from being displaced off the support surface 410 as the alignment device 400 is inserted into a crimping device.

[0164] Additionally, when a prosthetic valve is arranged on the support surface 410, as shown in FIGS.8-11, the alignment members 406 are axially aligned with respective commissures of the prosthetic valve. For example, as shown in FIG.9, the alignment member 406 is axially aligned with a commissure window 20 of the frame 12. As a result, asshown in FIG.11, the alignment members 406 are axially aligned with respective commissures 22 of the prosthetic valve 10 (which attach to the commissure windows 20 shown in FIG.9). As a result, the prosthetic valve is oriented and held (and maintained) on the support surface 410 in the specified circumferential orientation and, when coupled with a crimping device, is orientated within the crimping device at a specified circumferential orientation relative to the crimping device and a delivery apparatus coupled with the crimping device.

[0165] In some examples, a thickness (in the radial direction) of the alignment members 406 can be specified such that each alignment member 406 can deflect into the respective cut-out 452 and become aligned with the support surface 410 during crimping, as explained further below.

[0166] In some examples, the alignment members 406 can be made of a less stiff material than a remainder of the alignment device 400. For example, the alignment members 406 can comprise a first polymer and the remainder of the alignment device 400 can comprise a second polymer, where the first polymer is less stiff (and thus can bend or deflect more easily) than the second polymer. In some examples, the first polymer is Delrin, Acetal, ABS, or the like. As such, the alignment members 406 can have increased flexibility to capture and release the prosthetic valve.

[0167] When the alignment members 406 comprise a different material than a remainder of the alignment device, the alignment members 406 can be attached thereto (for example, to the axial wall 446 of the coupling portion 402) by a snap-fit connection, glue, or via over molding.

[0168] For reference, a coordinate axis system is shown in FIG.7, which depicts the radial direction 405 and axial direction 403, which are relative to the central longitudinal axis 401 of the alignment device 400.

[0169] In some examples, one or more alignment indicators 466 can be disposed in an axial wall 368 at the second end 444 of the support portion 404 (as shown in FIGS.6-8). Each alignment indicator 466 can be axially aligned with a corresponding alignment member 406. As such, each alignment indicator 466 can be configured to indicate an axial location for a commissure of a prosthetic valve when mounted on the support surface 410.

[0170] In some examples, the alignment indicators 466 may not be axially aligned with the corresponding alignment members 406 (for example, they may be offset from each other).

[0171] In some examples, commissures of the prosthetic valve may not be aligned with the alignment indicators 466 and / or alignment members 406 when mounting the prosthetic valve onto the alignment device 400. In such examples, different features of the prosthetic valve can be aligned with the alignment members 406 and / or alignment indicators 466.

[0172] In some examples, the alignment indicators 466 can be arrows, lines, or variously shaped raised markings protruding from the axial wall 468.

[0173] In some examples, the alignment indicators 466 can be arrows, lines, or variously shaped markings in the axial wall 468. For example, the alignment indicators 466 can be colored differently than a remainder of the alignment device 400.

[0174] In some examples, the alignment device 400 may not include alignment indicators 466.

[0175] FIG.20 depicts an exemplary alignment device 1000 that is similar to the alignment device 400, however each cut-out 1052 in the support portion 404 can have a wider, first section 1040 and a narrower, second section 1042, rather than being a constant width or having a relatively constant width that may taper slightly along its length, as in the alignment device 400. The cut-outs 1052 of the alignment device 1000 may function and be arranged with the support portion 404 similar to the cut-outs 452, but with a different shape, as described herein.

[0176] The same or similar components between the alignment device 400 and the alignment device 1000 are numbered the same in FIG.20 and will not be re-described for the sake of brevity.

[0177] In some examples, as shown in FIG.20, the first section 1040 of each cut-out 1052 can extend from the first end 442 of the support portion 404 toward the second end 444 of the support portion 404 (or toward a mid-point between the first end 442 and second end 444, in some examples) and the second section 1042 can extend from an end of the first section 1040 toward the second end 444 of the support portion 404. In this way, the first section 1040 is disposed at and closer to the first end 442 than the second section 1042, and the second section 1042 is disposed closer to the second end 444 than the first section 1040. A length of the cut-out 1052, as defined in an axial direction, is defined from a first end of the first section 1040 to a second end of the second section 1042.

[0178] The first section 1040 has a first width 1044 and the second section has a second width 1046 that is smaller than the first width 1044. In some examples, the first width 1044is constant along a length of the first section 1040 and the second width 1046 is constant along a length of the second section 1042.

[0179] In some examples, the first width 1044 tapers (or decreases) slightly from the first end 442 to the second section 1042 and / or the second width 1046 tapers (or decreases) slightly from the first section 1040 toward the second end 444. In such cases, the first width 1044 and the second width 1046 can be an average width of the respective first section 1040 and second section 1042, or a maximum width of the respective first section 1040 and second section 1042. In some examples, as shown in FIG.20, the maximum width of the second section 1042 is smaller than the minimum width of the first section 1040.

[0180] The first width 1044 and second width 1046 can be specified based on a width of the alignment member 1006 that extends along the cut-out 1052. For example, the first width 1044 and the second width 1046 can be specified such that they are wider than the portions of the alignment member 1006 that extends over the respective first section 1040 and second section 1042.

[0181] In some examples, as shown in FIG.20, a first portion of the alignment member 1006 can be wider than a second portion, or the remainder, of the alignment member 1006. For example, the stop element 1062 of the retention feature 1054 of each alignment member 1006, which is spaced axially from the protrusion 1060 of the retention feature 1054 by an indented region 1058, can have a width 1066 that is larger than a width of the protrusion 460 (or a more distal portion) of the retention feature 1054. In some examples, by having a larger width 1066, the stop element 1062 can have increased surface area for interfacing with the frame of the prosthetic valve (such as an apex), when the prosthetic valve is arranged on the alignment device 1000.

[0182] In such instances, the first width 1044 of the first section 1040 can be specified to be wider than the width 1066 of the stop element 1062, and the second width 1046 of the second section 1042 can be specified to be smaller than the first width 1044 but larger than the width of the more distal portion of the retention feature 1054 (e.g., the protrusion 1060).

[0183] As a result, the cut-out 1052 can have a contour that more closely follows the shape / width of the alignment member 1006 extending along the cut-out 1052. This results in an increase in surface area of the support surface 410 of the support portion 404 and thus, when a prosthetic valve is arranged on the support surface 410, the leaflets of the prosthetic valve have increased contact with the support surface 410, thereby enabling the alignmentdevice 1000 to be ejected from the crimping device during crimping more easily (for example, as opposed to having a cut-out with a larger width along its length that is specified according to a widest portion of the alignment member, which thereby reduces a total surface area of the support surface 410).

[0184] In some examples, each cut-out 1052 can have more than two sections with varying widths. For example, a cut-out 1052 may have a first section with a first width, a second section with a second width, and a third section with a third width, where the three widths are all different. For example, the cut-out 1052 may include a third section that extends from the first end 442 to the first section 1040 and has a third width that is smaller than the first width 1044 (for example, slightly larger than the leg 1064 of the alignment member 1006). In this way, the wider first section 1040 may primary surround the stop element 1062.

[0185] FIG.19 presents a method 900 for radially compressing a prosthetic valve onto a delivery apparatus with a crimping device while the prosthetic valve is held in a predetermined circumferential orientation and axial position within and relative to the crimping device. The method 900 is described below with reference to FIGS.11-13. However, it should be noted that the method 900 explained below can also be used with other alignment devices that are configured to rotationally align commissures of a prosthetic valve relative to the crimping device and axially align the prosthetic valve within the crimping device, such as the alignment devices shown in FIGS.14-18 and 20, as described further herein, and / or differently configured crimping devices (but which have similar mating components for mating with the alignment device, as described herein).

[0186] The method 900 begins at 902 by placing a prosthetic valve (for example, prosthetic valve 10) in a radially expanded configuration over a support surface of a tapered support portion of an alignment device and rotationally aligning the prosthetic valve on the support surface such that commissures of the prosthetic valve are axially aligned with alignment members of the alignment device. For example, as shown in FIG.11, the prosthetic valve 10 can be positioned on the support surface 410 of the support portion 404 of the alignment device 400. As a result, leaflets of the prosthetic valve 10 can be held open. The prosthetic valve 10 can be rotationally (or circumferentially) aligned on the support surface 410 such that the commissures 22 of the prosthetic valve 10 are axially aligned with the corresponding alignment members 406.

[0187] The method 900 can further include, at 904, coupling a retention feature at a free end of each alignment member to the prosthetic valve to hold the prosthetic valve in place on the support surface. The support portion extends from a proximal end of a coupling portion of the alignment device, the alignment members extend axially outward from the proximal end of the coupling portion. For example, as shown in FIGS.8-11, each retention feature 454 can be hooked around one or more struts of the frame 12 such that an apex 30 that is axially aligned with a commissure 22 is received in the indented region 458 and the apex 30 is disposed adjacent or abuts the stop element 462. In some examples, as shown in FIG.9, the protrusion 460 extends into a cell 34 of the frame 12. As a result, the prosthetic valve 10 is held in place on the support surface 410 (as shown in FIG.11).

[0188] The method 900 can further include, at 906, inserting the prosthetic valve held on the support surface into a channel of a crimping device, the channel being surrounded by a plurality of pressing surfaces of the crimping device. For example, as shown in FIG.12, the alignment device 400, with the prosthetic valve 10 mounted thereon (frame 12 is shown in FIG.12 for illustration purposes), can be inserted into the distal face 304 (or side) of the crimping device 300, with the valve and the second end 444 of the support portion 404 entering the channel 390 first.

[0189] The method 900 can further include, at 908, coupling the coupling member 422 of the alignment device 400 with the crimping device (such as inserting the coupling member 422 into the complementary recess (cut-out portion 308) in the distal face 304 of the crimping device 300) such that the alignment device 400 is held in a specified circumferential orientation relative to the crimping device 300 (as shown in FIG.12).

[0190] In some examples, the method 900 at 906 and / or 908 can further include sliding the retaining member(s) 432 of the alignment device 400 along a surface defining the channel 390 of the crimping device 300 as the alignment device 400 is inserted into the channel 390 and moving the retaining member(s) 432 radially outward and into corresponding slots in the crimping device 300 such that the alignment device 400 is retained in a specified axial orientation within the channel 390. Further details of this interface and methods utilizing the retaining members can be found in U.S. Patent Application No.63 / 533,555, filed August 18, 2023, which is incorporated by reference herein, as already noted above.

[0191] In some examples, the method 900 can further include, at 910, prior to crimping, inserting a valve mounting portion of a delivery apparatus (e.g., delivery apparatus 100) intothe channel 390 (from an opposite side of the crimping device 300, in some examples), and through the central channel 408 of the alignment device 400. In some instances, a positioning device coupled to the delivery apparatus can be coupled to the proximal face of the crimping device 300, thereby holding the valve mounting portion of the delivery apparatus in a specified circumferential and axial orientation within the crimping device, and relative to the prosthetic valve.

[0192] The method 900 can further include, at 912, radially compressing the prosthetic valve placed within the channel of the crimping device (onto the valve mounting portion of the delivery apparatus, for example) by actuating the crimping device to move the pressing surfaces radially inwardly. The radially compressing causes the alignment members to deflect radially inward and the alignment device to be moved axially out of and away from the prosthetic valve.

[0193] For example, as shown in FIG.13, during actuation of the crimping device 300 and crimping of the prosthetic valve 10 to the valve mounting portion of the delivery apparatus, the pressing surfaces 384 of the crimping device 300 move radially inward toward the center of the channel 390, thereby radially compressing the prosthetic valve 10. As the pressing surfaces 384 move inward, they press on the radially outward facing surfaces of the alignment members 406 and cause the free ends 450 of the alignment members 406 to deflect radially inward and into the cut-outs 452. Thus, the retention features 454 are also pressed radially inward and disengage from the frame 12 of the prosthetic valve 10.

[0194] In some examples, the alignment device 400 can remain at least partially inside the channel 390 following crimping (e.g., when the pressing surfaces 384 have finished radially compressing the valve onto the delivery apparatus).

[0195] In some examples, the alignment device 400 can move out of and / or fall out of the crimping device 300 slowly as the pressing surfaces 384 radially compress the valve onto the delivery apparatus.

[0196] Further details on crimping a prosthetic valve mounted on support body to the valve mounting portion of the delivery apparatus and coupling a positioning device coupled to a delivery apparatus to the crimping device can be found in in PCT Patent Publication Nos. WO 2022 / 046585 and WO 2022 / 046319 and U.S. Patent Application No.63 / 533,555, filed August 18, 2023, which are incorporated by reference herein in their entireties.

[0197] By utilizing the alignment device 400 (or a similar alignment device) for rotationally and axially aligning a prosthetic valve within a crimping device, relative to a delivery apparatus arranged within the crimping device, the prosthetic valve can be radially compressed onto a valve mounting portion of the delivery apparatus in a specified circumferential orientation, axial orientation, or both, relative to the delivery apparatus. Further, the specific features of the alignment device 400, including the retention features 454 of the alignment members 406, can allow for a variety of sizes of prosthetic valves (such as smaller diameter valves, as described above) to be held in place on the support surface 410 of the alignment device 400, thereby ensuring that the prosthetic valve is maintained in the desired orientation on the alignment device 400 and within the crimping device (when the alignment device 400 is coupled with the crimping device).

[0198] FIG.14 depicts an exemplary alignment device 500 that is configured to receive a prosthetic valve thereon and couple to a crimping device. The alignment device 500 can be similar to the alignment device 400, except its support portion 504 has two tapered sections having different angles or slopes (instead of a tapered support portion with a constant slope along its entire length) and the alignment device 500 does not include alignment members.

[0199] For example, the alignment device 500 includes a coupling portion 502 and a central channel 508 extending through the coupling portion 502 and the support portion 504. FIG. 14 is schematic, and for the ease of illustration, the coupling portion 502 is not shown in detail. However, in some examples, the coupling portion 502 can be the same as, or similar to, the coupling portion 402, as described above.

[0200] The support portion 504 comprises a first section 510 that defines a first end 514 of the support portion 504 and that extends away from the coupling portion 502. An outer surface 522 of the first section 510 has a first slope or first angle 518 relative to a line that is parallel to a central longitudinal axis 501 of the alignment device 500.

[0201] The support portion 504 further comprises a second section 512 that extends from the first section 510 to an opposite, second end 516 of the support portion 504. An outer surface 524 of the second section 512 has a second slope or second angle 520 relative to a line that is parallel to the central longitudinal axis 501 of the alignment device 500.

[0202] The first angle 518 is smaller than the second angle 520. The smaller, first angle 518 of the first section 510 allows for more contact of the outer surface 522 with leaflets of a prosthetic valve mounted thereon. As a result, a friction force between outer surface 522 ofthe first section 510 and the prosthetic valve leaflets can enable the prosthetic valve to be held in place on the support portion 504 (for example during insertion into a crimping device, similar to as shown in FIG.12), while still enabling the alignment device to release smoothly from within the prosthetic valve during crimping.

[0203] In some examples, the first angle 518 is in a range of 2-10 degrees or 3-7 degrees.

[0204] In some examples, the second angle 520 is in a range of 4-12 degrees or 5-9 degrees.

[0205] FIG.15 depicts an exemplary alignment device 600 that is configured to receive a prosthetic valve thereon and couple to a crimping device. The alignment device 600 can be the same as the alignment device 500 described above, except its support portion 604 includes an additional, third section 606 that extends between a first end 614 of the support portion 604 that is disposed at a coupling portion 602 and a first section 610 (where the coupling portion 602 can be the same as or similar to the coupling portion 402, as described above).

[0206] For example, the alignment device 600 comprises a first section 610 with an outer surface 622 having a first angle that can be the same or similar to the first angle 518 described above.

[0207] The alignment device 600 comprises a second section 612 with an outer surface 624 having a second angle that can be the same or similar to the second angle 520 described above. As such, the first angle of the first section 610 can be smaller than the second angle of the second section 512, thereby increasing the contact surface area between the outer surface 622 and leaflets 652 of a prosthetic valve 650, as depicted schematically in FIG.15.

[0208] In some examples, the prosthetic valve 650 can be one of the prosthetic valves described herein, such as prosthetic valves 10, 200, and 250.

[0209] Thus, the first section 610 can extend between the third section 606 and the second section 612, and the second section 612 can extend to a second end 616 of the support portion 604.

[0210] The third section 606 defines an axially facing surface 626 (or wall) that forms a stop for an end of the prosthetic valve 650, such as an end of the frame 654 of the prosthetic valve 650 (as shown schematically in FIG.15). As a result, the axially facing surface 626 can control (or set) an axial location for the prosthetic valve 650 on the support portion 604.

[0211] In some examples, the axially facing surface 626 can comprise visual indicators (such as markings, indentations, or the like) that identify target circumferential locations for thecommissures of the prosthetic valve 650. As such, the visual indicators can allow for the prosthetic valve to be mounted on the support portion 604 in a specified circumferential configuration.

[0212] FIG.16 depicts an exemplary alignment device 700 that is configured to receive a prosthetic valve thereon and couple to a crimping device. The alignment device 700 includes a coupling portion 702, a support portion 704, and a central channel 708 extending through the coupling portion 702 and the support portion 704. The alignment device 700 further includes a plurality of axially extending alignment members 706.

[0213] The support portion 704 has a support surface 710 with a plurality of apertures 712 spaced circumferentially apart around the support surface 710. The apertures 712 are adjacent to free ends 714 of the alignment members 706.

[0214] In some examples, the apertures 712 are aligned with the free ends 714 of the alignment members 706.

[0215] The apertures 712 are configured to receive apices of a frame of a prosthetic valve (such as apices of the frame 12 or 252). As such, the apertures 712 can define retention features configured to hold the prosthetic valve in place on the support surface 710, when mounted on the alignment device 700.

[0216] Apart from the inclusion of apertures 712, the alignment device 700 can be the same or similar to the alignment devices described in U.S. Patent Application No.63 / 533,555, filed August 18, 2023, which is incorporated by reference herein in its entirety. In some examples, a slope or angle of the taper of the support surface can be smaller than those described in U.S. Patent Application No.63 / 533,555.

[0217] FIGS.17 and 18 depict an exemplary alignment device 800 that is configured to receive a prosthetic valve thereon and couple to a crimping device. The alignment device 800 can be the same or similar to the alignment device 700, except instead of apertures 712, a support surface 810 of a support portion 804 of the alignment device 800 can have a relatively small angle 812 that is sized to maintain a prosthetic valve secured on the support surface 810 when inserting the support portion 804 into a crimping device and prior to crimping. For example, the alignment device 800 includes a coupling portion 802, a central channel 808 extending through the coupling portion 802 and the support portion 804, and alignment members 806 (that can be the same or similar to the alignment members 706).

[0218] FIG.17 is schematic, and for the ease of illustration, the coupling portion 802 is not shown in detail. However, in some examples, the coupling portion 802 can be the same as, or similar to, the coupling portion 402, as described above and / or the coupling portion described in U.S. Patent Application No.63 / 533,555.

[0219] In some examples, the angle 812 of the support surface 810 can be less than eight degrees.

[0220] In some examples, the angle 812 can be in a range of 1-8 degrees.

[0221] The relatively small angle 812 can allow for increased contact surface area between the support surface 810 and leaflets of a prosthetic valve mounted thereon, thereby increasing a friction force between the valve and support surface 810.

[0222] Additionally, as shown in FIGS.17 and 18, the support portion 804 can include cut- outs 814 that extend an entire length of the support portion 804 (for example, from a wider, first end 816 to a narrower, second end 818 of the support portion 804). The full-length cut- outs 814 allow the support surface 810 of the support portion 804 to collapse radially inward during crimping, thereby creating a larger angle that enables the alignment device 800 to be ejected from the crimping device during crimping. In this way, the angle 812 shown in FIG. 17 can be a resting (non-deformed) angle of the support surface 810 and this angle 812 increases during crimping in response to the crimping jaws (or pressing surfaces) of the crimping device pressing radially inward against the support surface 810.

[0223] FIG.18 is a simplified, schematic end view of the alignment device 800, from the second end 818), showing the spaced apart cut-outs 814 that extend through the support portion 804.

[0224] In this way, the various alignment devices described herein provide support portions that enable prosthetic valves having varying diameters (especially, smaller diameter valves, as described herein) to be held in place on the support surface of the support portion, even during insertion into a crimping device. As a result, the prosthetic valve can be maintained on the alignment device, and thus inside the crimping device, in a desired circumferential and / or axial orientation relative to the alignment device and crimping device. Delivery Techniques

[0225] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion ofthe delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). 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.

[0226] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Additionally and / or alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0227] 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 advancedthrough the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0228] 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.

[0229] 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.

[0230] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Additional Examples of the Disclosed Technology

[0231] 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.

[0232] Example 1. An alignment device for a prosthetic heart valve, comprising a coupling portion configured to couple with a crimping device; a support portion that tapers from awider end that is disposed adjacent a first end of the coupling portion to a narrower end, wherein the support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve thereon; one or more axially extending alignment members, each alignment member extending axially outward from the first end of the coupling portion and over the support portion, each alignment member comprising a free end with a retention feature that is configured to hold the prosthetic heart valve in a specified orientation on the support surface when the prosthetic heart valve is arranged on the support surface; and a central channel extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

[0233] Example 2. The alignment device of any example herein, particularly example 1, wherein the retention feature is configured to hold the prosthetic heart valve in a specified circumferential orientation and axial orientation on the support surface.

[0234] Example 3. The alignment device of any example herein, particularly either example 1 or example 2, wherein the retention feature is shaped to hook around a portion of a frame of the prosthetic heart valve.

[0235] Example 4. The alignment device of any example herein, particularly any one of examples 1-3, wherein the retention feature comprises a hook defining an indented region, a protrusion disposed on a first side of the indented region, and a stop element disposed on an opposite, second side of the indented region, wherein the indented region is configured to receive a strut of a frame of the prosthetic heart valve.

[0236] Example 5. The alignment device of any example herein, particularly any one of examples 1-4, wherein the one or more alignment members includes at least two alignment members that are spaced circumferentially apart around the support portion.

[0237] Example 6. The alignment device of any example herein, particularly any one of examples 1-5, wherein the support portion comprises one or more cut-outs in the support surface that extend through the support portion, and wherein each alignment member extends over a respective cut-out of the one or more cut-outs.

[0238] Example 7. The alignment device of any example herein, particularly example 6, wherein each cut-out extends through a wall of the support portion, from the support surface to the central channel.

[0239] Example 8. The alignment device of any example herein, particularly either example 6 or example 7, wherein each cut-out extends from the wider end of the support portion toward, but spaced away from, the narrower end of the support portion.

[0240] Example 9. The alignment device of any example herein, particularly any one of examples 6-8, wherein the one or more cut-outs includes a plurality of cut-outs spaced circumferentially apart around the support portion, and wherein the support surface extends between adjacent cut-outs of the plurality of cut-outs.

[0241] Example 10. The alignment device of any example herein, particularly any one of examples 6-9, wherein a width of each cut-out, defined in a circumferential direction, is wider than a width of a respective alignment member of the one or more alignment members.

[0242] Example 11. The alignment device of any example herein, particularly any one of examples 6-10, wherein the free end of each alignment member is configured to deflect radially inward toward the central channel and into a respective cut-out.

[0243] Example 12. The alignment device of any example herein, particularly any one of examples 1-11, wherein the coupling portion comprises an axially extending coupling member that is configured to couple with the crimping device.

[0244] Example 13. The alignment device of any example herein, particularly example 12, wherein the coupling member extends axially from a second end toward the first end of the coupling portion, the second end arranged opposite the first end.

[0245] Example 14. The alignment device of any example herein, particularly either example 12 or example 13, wherein the coupling member has a free end that tapers from its opposing radially outward facing and radially inward facing surfaces to a point.

[0246] Example 15. The alignment device of any example herein, particularly either example 13 or example 14, wherein the coupling portion comprises a cylindrical wall with an outer surface and an inner surface at least partially defining the central channel, and wherein the cylindrical wall extends from the first end to the second end of the coupling portion.

[0247] Example 16. The alignment device of any example herein, particularly example 15, wherein the coupling member is spaced radially away from the outer surface of the cylindrical wall.

[0248] Example 17. The alignment device of any example herein, particularly either example 15 or example 16, further comprising at least one retaining member disposed in thecylindrical wall of the coupling portion, wherein the retaining member is configured to retain an axial position of the alignment device inside a channel of the crimping device.

[0249] Example 18. The alignment device of any example herein, particularly example 17, wherein the at least one retaining member comprises a finger with a free end and attached end that are formed by a U-shaped slot in the cylindrical wall, wherein the free end includes a protrusion that protrudes radially outward from an outer surface of the free end, and wherein the free end is configured to deflect radially inward and outward relative to the attached end.

[0250] Example 19. The alignment device of any example herein, particularly either example 17 or example 18, wherein the at least one retaining member includes two retaining members disposed in opposite sides of the cylindrical wall of the coupling portion.

[0251] Example 20. The alignment device of any example herein, particularly any one of examples 1-19, wherein the support portion comprises one or more alignment indicators disposed at the narrower end, and wherein each alignment indicator is axially aligned with a corresponding alignment member of the one or more alignment members.

[0252] Example 21. The alignment device of any example herein, particularly any one of examples 1-20, wherein the portion of the prosthetic heart valve that the retention feature attaches to is axially aligned with a commissure of the prosthetic heart valve.

[0253] Example 22. An assembly comprising the alignment device of any example herein, particularly any one of examples 1-21, and the prosthetic heart valve.

[0254] Example 23. A system for crimping a prosthetic heart valve to a delivery apparatus, comprising the alignment device of any example herein, particularly any one of examples 1- 21; and a crimping device which comprises a channel, wherein a first opening to the channel is disposed on a side of the crimping device, the first opening configured to receive the support portion of the alignment device therethrough, and wherein the crimping device includes a recess in the side that is configured to receive a coupling member of the coupling portion of the alignment device therein.

[0255] Example 24. The system of any example herein, particularly example 23, wherein the channel of the crimping device includes a slot, and wherein the coupling portion of the alignment device further comprises a retaining member that is configured to couple with the slot such that the alignment device is held in a specified axial orientation within and relative to the crimping device.

[0256] Example 25. The system of any example herein, particularly example 24, wherein the retaining member is a first retaining member, and wherein the coupling portion comprises a second retaining member spaced circumferentially apart from the first retaining member.

[0257] Example 26. The system of any example herein, particularly example 24, wherein the retaining member is disposed in a cylindrical wall of the coupling portion, the cylindrical wall having an outer surface and an opposite, inner surface that at least partially defines the central channel of the alignment device.

[0258] Example 27. The system of any example herein, particularly example 26, wherein the retaining member comprises a finger with a free end and attached end that are formed by a U- shaped slot in the cylindrical wall, wherein the free end includes a protrusion that protrudes radially outward from an outer surface of the free end, and wherein the free end is configured to deflect radially inward and outward relative to the attached end.

[0259] Example 28. The system of any example herein, particularly example 27, wherein the protrusion is a spherical nub.

[0260] Example 29. The system of any example herein, particularly either example 27 or example 28, wherein a surface that defines the channel of the crimping device has a ramped portion at an entrance to the channel, wherein the ramped portion ramps radially inward from the side of the crimping device toward an inside of the channel, and wherein the protrusion is configured to slide along the surface to the slot.

[0261] Example 30. The system of any example herein, particularly any one of examples 23- 29, wherein the coupling member extends axially outward from a second end of the coupling portion toward the first end of the coupling portion, and wherein the coupling member is shaped to fit within the recess of the crimping device and circumferentially align the alignment device within and relative to the crimping device.

[0262] Example 31. An alignment device for a prosthetic heart valve, comprising a coupling portion configured to couple with a crimping device; a support portion that tapers from a wider end that is disposed adjacent a first end of the coupling portion to a narrower end, wherein the support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve thereon and one or more cut-outs that extend through a wall of the support portion and from the first end of the coupling portion toward the narrower end of the support portion; one or more axially extending alignment members, each alignment member extending axially outward from the first end of the coupling portion and along arespective cut-out of the one or more cut-outs, each alignment member comprising a free end with a retention feature that is configured to hook around a portion of a frame of the prosthetic heart valve that is axially aligned with a commissure of the prosthetic heart valve and hold the prosthetic heart valve in place on the support surface when the prosthetic heart valve is arranged on the support surface; and a central channel extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

[0263] Example 32. The alignment device of any example herein, particularly example 31, wherein each cut-out extends through the wall of the support portion, from the support surface to the central channel.

[0264] Example 33. The alignment device of any example herein, particularly either example 31 or example 32, wherein each cut-out has a first end disposed at the wider end of the support portion and a second end that is disposed closer to the narrower end than the wider end of the support portion but is spaced away from the narrower end of the support portion.

[0265] Example 34. The alignment device of any example herein, particularly any one of examples 31-33, wherein each cut-out has a first width that is wider than a second width of a respective alignment member of the one or more axially extending alignment members.

[0266] Example 35. The alignment device of any example herein, particularly any one of examples 31-34, wherein each alignment member extends over and along a respective cut- out, in a direction of a central longitudinal axis of the alignment device, and wherein each alignment member has a first length that is shorter than a second length of the respective cut- out.

[0267] Example 36. The alignment device of any example herein, particularly any one of examples 31-35, wherein the free end of each alignment member is configured to deflect radially inward toward the central channel and into a respective cut-out in response to a radially inwardly applied force.

[0268] Example 37. The alignment device of any example herein, particularly any one of examples 31-36, wherein the one or more alignment members includes a plurality of alignment members spaced circumferentially apart around the support portion, and wherein the one or more cut-outs includes a plurality of cut-outs spaced circumferentially apart around the support portion.

[0269] Example 38. The alignment device of any example herein, particularly any one of examples 31-37, wherein the retention feature comprises a protrusion and an indented region proximal to the protrusion, wherein the indented region is configured to receive a strut of the frame of the prosthetic heart valve and the protrusion is configured to extend into an open cell of the frame that is at least partially defined by the strut.

[0270] Example 39. The alignment device of any example herein, particularly example 38, wherein the retention feature further comprises a stop element disposed proximal to the indented region, and wherein the stop element and protrusion are configured to receive the strut therebetween and hold the frame axially and circumferentially in place on the support surface.

[0271] Example 40. The alignment device of any example herein, particularly any one of examples 31-39, wherein the coupling portion comprises an axially extending coupling member that is configured to couple with a recess in the crimping device.

[0272] Example 41. The alignment device of any example herein, particularly example 40, wherein the coupling member extends axially from a second end of the coupling portion toward the first end of the coupling portion, the second end arranged opposite the first end.

[0273] Example 42. The alignment device of any example herein, particularly either example 40 or example 41, wherein the coupling member has a free end that tapers from its opposing radially outward facing and radially inward facing surfaces to a point.

[0274] Example 43. The alignment device of any example herein, particularly either example 41 or example 42, wherein the coupling portion comprises a cylindrical wall with an outer surface and an inner surface at least partially defining the central channel, wherein the cylindrical wall extends from the first end to the second end of the coupling portion, and wherein the coupling member is spaced radially outward of the outer surface of the cylindrical wall.

[0275] Example 44. The alignment device of any example herein, particularly example 43, further comprising at least one retaining member disposed in the cylindrical wall of the coupling portion, wherein the retaining member is configured to retain an axial position of the alignment device inside a channel of the crimping device.

[0276] Example 45. The alignment device of any example herein, particularly example 44, wherein the at least one retaining member comprises a finger with a free end and attached end that are formed by a U-shaped slot in the cylindrical wall, wherein the free end includes aprotrusion that protrudes radially outward from an outer surface of the free end, and wherein the free end is configured to deflect radially inward and outward relative to the attached end.

[0277] Example 46. The alignment device of any example herein, particularly either example 44 or example 45, wherein the at least one retaining member includes two retaining members disposed in opposite sides of the cylindrical wall of the coupling portion.

[0278] Example 47. The alignment device of any example herein, particularly example 46, wherein each retaining member of the two retaining members is circumferentially offset from the coupling member.

[0279] Example 48. The alignment device of any example herein, particularly any one of examples 31-47, wherein the support portion comprises one or more alignment indicators disposed at the narrower end, and wherein each alignment indicator is axially aligned with a corresponding alignment member of the one or more alignment members.

[0280] Example 49. An assembly comprising the alignment device of any example herein, particularly any one of examples 31-48, and the prosthetic heart valve.

[0281] Example 50. A system for crimping a prosthetic heart valve to a delivery apparatus, comprising the alignment device of any example herein, particularly any one of examples 31- 48; and a crimping device which comprises a channel, wherein a first opening to the channel is disposed on a distal side of the crimping device, the first opening configured to receive the support portion of the alignment device therethrough, and wherein the crimping device includes a recess in the distal side that is configured to receive a coupling member of the coupling portion of the alignment device therein.

[0282] Example 51. The system of any example herein, particularly example 50, wherein the coupling member extends axially outward from a second end of the coupling portion toward the first end of the coupling portion, and wherein the coupling member is shaped to fit within the recess of the crimping device and circumferentially align the alignment device within and relative to the crimping device.

[0283] Example 52. The system of any example herein, particularly either example 50 or example 51, wherein the crimping device comprises a plurality of pressing surfaces surround the channel of the crimping device, and wherein the free end of each alignment member is configured to deflect radially inward toward the central channel of the alignment device in response to a radially inward force applied thereto by the pressing surfaces.

[0284] Example 53. An alignment device for a prosthetic heart valve comprising a coupling portion configured to couple with a crimping device and having opposing first and second ends; a support portion having opposing first and second ends and extending axially from the second end of the coupling portion, wherein the support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve thereon and a plurality of cut-outs in the support surface that extend through a wall of the support portion and extend from the first end of the support portion that is disposed adjacent to the second end of the coupling portion toward the second end of the support portion that is disposed axially away from the coupling portion, and wherein the plurality of cut-outs are spaced circumferentially apart around the support portion; a plurality of axially extending alignment members, each alignment member extending axially outward from the second end of the coupling portion and along a respective cut-out of the plurality of cut-outs, each alignment member comprising a free end with a retention feature that is configured to receive a portion of the prosthetic heart valve and hold the prosthetic heart valve in place on the support surface when the prosthetic heart valve is arranged on the support surface, and wherein the free end is deflectable radially inward, into the respective cut-out during crimping or the prosthetic heart valve with the crimping device; and a central channel extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

[0285] Example 54. The alignment device of any example herein, particularly example 53, wherein the support portion tapers radially inward from its first end to its second end, and wherein the second end of the support portion is narrower than the first end of the support portion.

[0286] Example 55. The alignment device of any example herein, particularly either example 53 or example 54, wherein the support surface defines an outward facing surface of the wall of the support portion and an inward facing surface of the wall defines a portion of the central channel extending through the support portion.

[0287] Example 56. The alignment device of any example herein, particularly any one of examples 53-55, wherein each cut-out has a first end disposed at the first end of the support portion and a second end that is disposed closer to the second end of the support portion than the first end of the support portion but is spaced away from the second end of the support portion.

[0288] Example 57. The alignment device of any example herein, particularly any one of examples 53-56, wherein each cut-out has a first width that is wider than a second width of a respective alignment member of the plurality of alignment members.

[0289] Example 58. The alignment device of any example herein, particularly any one of examples 53-57, wherein each cut-out has a first length that is longer than a second length of a respective alignment member of the plurality of alignment members.

[0290] Example 59. The alignment device of any example herein, particularly any one of examples 53-58, wherein each alignment device is configured as a cantilever where the free end of each alignment member is configured to deflect radially inward toward the central channel and into a respective cut-out in response to a radially inwardly applied force.

[0291] Example 60. The alignment device of any example herein, particularly any one of examples 53-59, wherein the retention feature comprises an indented region that indents radially inward relative to portions of the alignment member on both sides of the indented region, and wherein the indented region is configured to receive one or more struts of a frame of the prosthetic heart valve.

[0292] Example 61. The alignment device of any example herein, particularly example 60, wherein the retention feature further comprises a protrusion on a first side of the indented region and a stop element on an opposite, second side of the indented region, wherein the stop element is configured to interface with an end of the frame defined by the one or more struts, and wherein the protrusion is configured to extend into an open cell of the frame that is at least partially defined by the one or more struts.

[0293] Example 62. The alignment device of any example herein, particularly any one of examples 53-61, wherein the coupling portion comprises an axially extending coupling member that is configured to couple with a recess in the crimping device.

[0294] Example 63. The alignment device of any example herein, particularly example 62, wherein the coupling member extends axially from the first end toward the second end of the coupling portion.

[0295] Example 64. The alignment device of any example herein, particularly any one of examples 53-63, wherein the support portion comprises one or more alignment indicators disposed at the second end of the support portion, in an axially facing surface of the support portion, and wherein each alignment indicator is axially aligned with a corresponding alignment member of the plurality of alignment members.

[0296] Example 65. An assembly comprising the alignment device of any example herein, particularly any one of examples 53-64, and the prosthetic heart valve.

[0297] Example 66. A system for crimping a prosthetic heart valve to a delivery apparatus, comprising the alignment device of any example herein, particularly any one of examples 53- 64; and a crimping device which comprises a channel, wherein a first opening to the channel is disposed on a distal side of the crimping device, the first opening configured to receive the support portion of the alignment device therethrough, and wherein the crimping device includes a recess in the distal side that is configured to receive a coupling member of the coupling portion of the alignment device therein.

[0298] Example 67. The system of any example herein, particularly example 66, wherein the coupling member extends axially outward from a second end of the coupling portion toward the first end of the coupling portion, and wherein the coupling member is shaped to fit within the recess of the crimping device and circumferentially align the alignment device within and relative to the crimping device.

[0299] Example 68. The system of any example herein, particularly either example 66 or example 67, wherein the channel of the crimping device is surrounded by a plurality of pressing surfaces of the crimping device, and wherein the retention feature of each alignment member comprises a protrusion with a rounded tip that is configured to interface with the plurality of pressing surfaces during crimping of the prosthetic heart valve with the crimping device.

[0300] Example 69. A method comprising placing a prosthetic valve in a radially expanded configuration over a support surface of a tapered support portion of an alignment device and rotationally aligning the prosthetic valve on the support surface such that commissures of the prosthetic valve are axially aligned with alignment members of the alignment device, and coupling a retention feature at a free end of each alignment member to the prosthetic valve to hold the prosthetic valve in place on the support surface, wherein the support portion extends from a proximal end of a coupling portion of the alignment device, wherein the alignment members extend axially outward from the proximal end of the coupling portion, and wherein the coupling portion includes a coupling member; inserting the prosthetic valve held on the support surface into a channel of a crimping device, the channel being surrounded by a plurality of pressing surfaces of the crimping device; coupling the coupling member with the crimping device such that the alignment device is held in a specified circumferentialorientation relative to the crimping device; and radially compressing the prosthetic valve placed within the channel by actuating the crimping device to move the pressing surfaces radially inwardly, wherein the radially compressing causes the alignment members to deflect radially inward and disengage from the prosthetic valve, and causes the alignment device to be moved axially out of and away from the prosthetic valve.

[0301] Example 70. The method of any example herein, particularly example 69, further comprising, prior to the radially compressing the prosthetic valve by actuating the crimping device, inserting a valve mounting portion of a delivery apparatus into the channel of the crimping device and through a central channel of the alignment device, and wherein the radially compressing the prosthetic valve includes radially compressing the prosthetic valve onto the valve mounting portion of the delivery apparatus.

[0302] Example 71. The method of any example herein, particularly either example 69 or example 70, wherein the coupling portion of the alignment device comprises a cylindrical wall and a retaining member disposed in the cylindrical wall, and further comprising sliding the retaining member along a surface defining the channel of the crimping device as the alignment device is inserted into the channel and moving the retaining member radially outward and into a slot in the crimping device that is radially offset from the channel such that the alignment device is retained in a specified axial orientation within the channel.

[0303] Example 72. The method of any example herein, particularly example 71, wherein the radially compressing further causes the retaining member to uncouple from the slot and allow the alignment device to be moved axially out of and away from the prosthetic valve.

[0304] Example 73. The method of any example herein, particularly any one of examples 69-72, wherein placing the prosthetic valve over the support surface and rotationally aligning the prosthetic valve on the support surface includes, for each alignment member, hooking the retention feature around a strut defining an end portion of a frame of the prosthetic valve such the prosthetic valve is held axially and circumferentially in place on the support surface.

[0305] Example 74. The method of any example herein, particularly example 73, wherein the hooking the retention feature around the strut includes receiving an apex of the frame that joins two struts at an end of the frame within an indented region of the retention feature, abutting the apex against a stop element of the retention feature, and extending a protrusion of the retention feature through an open cell of the frame that is at least partially defined by the two struts.

[0306] Example 75. The method of any example herein, particularly any one of examples 69-74, wherein the radially compressing includes moving the pressing surfaces radially inwardly such that the pressing surfaces push against the retention feature of each alignment member and deflects the free end of each alignment member radially inward into a respective cut-out of a plurality of cut-outs disposed in a wall of the support portion, wherein the wall is defined between the support surface and a central channel of the alignment device.

[0307] Example 76. The method of any example herein, particularly any one of examples 69-75, wherein the alignment device comprises three alignment members, and wherein rotationally aligning the prosthetic valve on the support surface includes axially aligning each commissure of three commissures of the prosthetic valve with a corresponding alignment member of the three alignment members of the alignment device.

[0308] Example 77. The method of any example herein, particularly any one of examples 69-76, wherein the coupling member extends axially outward from a distal end of the coupling portion toward the support portion, and wherein coupling the coupling member with the crimping device includes inserting the coupling member into a complementary recess in a distal face of the crimping device such that the alignment device is held in the specified circumferential orientation relative to the crimping device.

[0309] Example 78. An alignment device for a prosthetic heart valve, comprising a coupling portion comprising a coupling member configured to couple with a crimping device; a support portion that tapers from a wider end that is disposed adjacent a first end of the coupling portion to a narrower end, wherein the support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve thereon, and wherein the support portion includes a plurality of apertures spaced circumferentially apart around the support portion, each aperture extending through a wall of the support portion; one or more axially extending alignment members, each alignment member extending axially outward from the first end of the coupling portion, over the support portion and to the support surface, each alignment member comprising a free end configured to abut an end of the prosthetic heart valve and be axially aligned with a commissure of the prosthetic heart valve when the prosthetic heart valve is arranged on the support surface, and wherein the plurality of apertures and the free end of each alignment member are spaced circumferentially apart at a same axial location along the support portion; and a central channel extending through the coupling portion and the support portion, in a direction of a central longitudinal axis of thealignment device, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

[0310] Example 79. An alignment device for a prosthetic heart valve, comprising a coupling portion configured to couple with a crimping device; a support portion having a wider end that is disposed adjacent a first end of the coupling portion and a narrower end spaced away from the coupling portion, the support portion comprising a first section that tapers radially inward from the wider end toward the narrower end at a first angle; a second section that tapers radially inward from the first section to the narrower end at a second angle, wherein the first angle is smaller than the second angle; and a central channel extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

[0311] Example 80. An alignment device for a prosthetic heart valve, comprising a coupling portion comprising a coupling member configured to couple with a crimping device; a support portion that tapers from a wider end that is disposed adjacent a first end of the coupling portion to a narrower end, wherein the support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve thereon, and wherein the support portion includes a plurality of cut-outs spaced apart around the support portion, each cut-out extending through a wall of the support portion and along an entire length of the support portion from the wider end to the narrower end; one or more axially extending alignment members, each alignment member extending axially outward from the first end of the coupling portion, over a respective cut-out of the plurality of cut-outs of the support portion and to the support surface, each alignment member comprising a free end configured to be axially aligned with a commissure of the prosthetic heart valve when the prosthetic heart valve is arranged on the support surface; and a central channel extending through the coupling portion and the support portion, in a direction of a central longitudinal axis of the alignment device, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

[0312] Example 81. The alignment device of any example herein, particularly example 80, wherein the free end of each alignment member is configured to abut an end of the prosthetic heart valve.

[0313] Example 82. The alignment device of any example herein, particularly example 80 or example 81, wherein an angle of the support surface, relative to the central longitudinal axis, is less than eight degrees.

[0314] Example 83. The alignment device of any example herein, particularly any one of examples 6-11 or any one of examples 31-33, wherein each cut-out comprises a first section with a first width and a second section with a second width that is smaller than the first width.

[0315] Example 84. The alignment device of any example herein, particularly example 83, wherein the first section extends from the wider end of the support portion, and wherein the second section extends from the first section toward the narrower end of the support portion.

[0316] Example 85. The alignment device of any example herein, particularly either example 83 or example 84, wherein the retention feature comprises a hook defining an indented region, a protrusion disposed on a first side of the indented region, and a stop element disposed on an opposite, second side of the indented region, wherein the indented region is configured to receive a strut of a frame of the prosthetic heart valve, and wherein the stop element is wider than and spaced axially from the protrusion.

[0317] Example 86. The alignment device of any example herein, particularly example 85, wherein the protrusion of the retention feature of each alignment member extends over the second section of the respective cut-out, and wherein the stop element of the retention feature of each alignment member extends over the first section of the respective cut-out.

[0318] Example 87. The alignment device of any example herein, particularly example 39, wherein stop element is wider than the protrusion, and wherein each cut-out has a first section extending from the wider end of the support portion and a second section extending from the first section towards the narrower end of the support portion, wherein the second section is narrower than the first section, wherein the protrusion extends over the second section of the respective cut-out, and wherein the stop element extends over the first section of the respective cut-out.

[0319] Example 88. An alignment device for a prosthetic heart valve, comprising: a coupling portion configured to couple with a crimping device; a support portion that tapers from a wider end that is disposed adjacent a first end of the coupling portion to a narrower end, wherein the support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve thereon and one or more cut-outs that extend through a wall of the support portion and from the first end of the coupling portion toward the narrower endof the support portion, wherein each cut-out comprises a first section with a first width and a second section with a second width that is smaller than the first width; one or more axially extending alignment members, each alignment member extending axially outward from the first end of the coupling portion and along a respective cut-out of the one or more cut-outs, each alignment member comprising a free end that is configured to interface with a frame of the prosthetic heart valve that is axially aligned with a commissure of the prosthetic heart valve when the prosthetic vale is arranged on the support surface; and a central channel extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

[0320] Example 89. The alignment device of any example herein, particularly example 88, wherein the first section extends from the wider end of the support portion, and wherein the second section extends from the first section toward the narrower end of the support portion.

[0321] Example 90. The alignment device of any example herein, particularly example 89, wherein the free end of each alignment member extends along the second section of the respective cut-out.

[0322] Example 91. The alignment device of any example herein, particularly example 89, wherein each alignment member comprises a protrusion defining the free end and a stop element spaced axially from the protrusion, wherein the stop element is configured to receive an apex of the frame, and wherein the stop element has a width, in a circumferential direction, that is wider than a width of the protrusion.

[0323] Example 92. The alignment device of any example herein, particularly example 91, wherein the protrusion extends over the second section of the respective cut-out, and wherein the stop element extends over the first section of the respective cut-out.

[0324] Example 93. The alignment device of any example herein, particularly example 88, wherein the free end of each alignment member includes a retention feature that is configured to hook around a portion of the frame of the prosthetic heart valve that is axially aligned with the commissure of the prosthetic heart valve and hold the prosthetic heart valve in place on the support surface when the prosthetic heart valve is arranged on the support surface.

[0325] Example 94. A method comprising sterilizing the prosthetic heart valve, apparatus, and / or assembly of any example.

[0326] Example 95. A prosthetic heart valve of any one of examples, wherein the prosthetic heart valve is sterilized.

[0327] 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 alignment device can be combined with any one or more features of another alignment device. As another example, any one or more features of one prosthetic valve can be combined with any one or more features of another prosthetic valve.

[0328] 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. An alignment device for a prosthetic heart valve, comprising: a coupling portion configured to couple with a crimping device; a support portion that tapers from a wider end that is disposed adjacent a first end of the coupling portion to a narrower end, wherein the support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve thereon; one or more axially extending alignment members, each alignment member extending axially outward from the first end of the coupling portion and over the support portion, each alignment member comprising a free end with a retention feature that is configured to hold the prosthetic heart valve in a specified orientation on the support surface when the prosthetic heart valve is arranged on the support surface; and a central channel extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

2. The alignment device of claim 1, wherein the retention feature is configured to hook around a portion of a frame of the prosthetic heart valve and hold the prosthetic heart valve in a specified circumferential orientation and axial orientation on the support surface.

3. The alignment device of either claim 1 or claim 2, wherein the retention feature comprises a hook defining an indented region, a protrusion disposed on a first side of the indented region, and a stop element disposed on an opposite, second side of the indented region, wherein the indented region is configured to receive a strut of a frame of the prosthetic heart valve.

4. The alignment device of any one of claims 1-3, wherein the one or more alignment members includes at least two alignment members that are spaced circumferentially apart around the support portion.

5. The alignment device of any one of claims 1-4, wherein the support portion comprises one or more cut-outs in the support surface that extend through the supportportion, and wherein each alignment member extends over a respective cut-out of the one or more cut-outs.

6. The alignment device of claim 5, wherein each cut-out extends through a wall of the support portion, from the support surface to the central channel.

7. The alignment device of either claim 5 or claim 6, wherein each cut-out extends from the wider end of the support portion toward, but spaced away from, the narrower end of the support portion.

8. The alignment device of any one of claims 5-7, wherein a width of each cut- out, defined in a circumferential direction, is wider than a width of a respective alignment member of the one or more alignment members.

9. The alignment device of claim 8, wherein each cut-out comprises a first section with a first width and a second section with a second width that is smaller than the first width.

10. The alignment device of claim 9, wherein the first section extends from the wider end of the support portion, and wherein the second section extends from the first section toward the narrower end of the support portion.

11. The alignment device of any one of claims 5-10, wherein the free end of each alignment member is configured to deflect radially inward toward the central channel and into a respective cut-out.

12. The alignment device of any one of claims 1-11, wherein the coupling portion comprises an axially extending coupling member that is configured to couple with the crimping device.

13. A system for crimping a prosthetic heart valve to a delivery apparatus, comprising:the alignment device of any one of claims 1-12; and a crimping device which comprises a channel, wherein a first opening to the channel is disposed on a side of the crimping device, the first opening configured to receive the support portion of the alignment device therethrough, and wherein the crimping device includes a recess in the side that is configured to receive a coupling member of the coupling portion of the alignment device therein.

14. An alignment device for a prosthetic heart valve, comprising: a coupling portion configured to couple with a crimping device; a support portion that tapers from a wider end that is disposed adjacent a first end of the coupling portion to a narrower end, wherein the support portion comprises an outward facing support surface that is configured to receive the prosthetic heart valve thereon and one or more cut-outs that extend through a wall of the support portion and from the first end of the coupling portion toward the narrower end of the support portion; one or more axially extending alignment members, each alignment member extending axially outward from the first end of the coupling portion and along a respective cut-out of the one or more cut-outs, each alignment member comprising a free end with a retention feature that is configured to hook around a portion of a frame of the prosthetic heart valve that is axially aligned with a commissure of the prosthetic heart valve and hold the prosthetic heart valve in place on the support surface when the prosthetic heart valve is arranged on the support surface; and a central channel extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus for the prosthetic heart valve therethrough.

15. The alignment device of claim 14, wherein each cut-out extends through the wall of the support portion, from the support surface to the central channel.

16. The alignment device of either claim 14 or claim 15, wherein each cut-out has a first end disposed at the wider end of the support portion and a second end that is disposed closer to the narrower end than the wider end of the support portion but is spaced away from the narrower end of the support portion.

17. The alignment device of any one of claims 14-16, wherein the free end of each alignment member is configured to deflect radially inward toward the central channel and into a respective cut-out in response to a radially inwardly applied force.

18. A method comprising: placing a prosthetic valve in a radially expanded configuration over a support surface of a tapered support portion of an alignment device and rotationally aligning the prosthetic valve on the support surface such that commissures of the prosthetic valve are axially aligned with alignment members of the alignment device, and coupling a retention feature at a free end of each alignment member to the prosthetic valve to hold the prosthetic valve in place on the support surface, wherein the support portion extends from a proximal end of a coupling portion of the alignment device, wherein the alignment members extend axially outward from the proximal end of the coupling portion, and wherein the coupling portion includes a coupling member; inserting the prosthetic valve held on the support surface into a channel of a crimping device, the channel being surrounded by a plurality of pressing surfaces of the crimping device; coupling the coupling member with the crimping device such that the alignment device is held in a specified circumferential orientation relative to the crimping device; and radially compressing the prosthetic valve placed within the channel by actuating the crimping device to move the pressing surfaces radially inwardly, wherein the radially compressing causes the alignment members to deflect radially inward and disengage from the prosthetic valve, and causes the alignment device to be moved axially out of and away from the prosthetic valve.

19. The method of claim 18, further comprising, prior to the radially compressing the prosthetic valve by actuating the crimping device, inserting a valve mounting portion of a delivery apparatus into the channel of the crimping device and through a central channel of the alignment device, and wherein the radially compressing the prosthetic valve includes radially compressing the prosthetic valve onto the valve mounting portion of the delivery apparatus.

20. The method of any one of either claim 18 or claim 19, wherein the radially compressing includes moving the pressing surfaces radially inwardly such that the pressing surfaces push against the retention feature of each alignment member and deflects the free end of each alignment member radially inward into a respective cut-out of a plurality of cut- outs disposed in a wall of the support portion, wherein the wall is defined between the support surface and the channel of the alignment device.

Images