WO2025231282A1

WO2025231282A1 - Devices and methods for crimping prosthetic implants

Info

Publication number: WO2025231282A1
Application number: PCT/US2025/027360
Authority: WO
Inventors: Grant Jason Gangeness; James William Ventress; Teresa Truc LAI; Danica Wuan Ting WONG; Tri D. Tran
Original assignee: Edwards Lifesciences Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 2024-05-02
Filing date: 2025-05-01
Publication date: 2025-11-06
Anticipated expiration: 2026-11-02

Abstract

An assembly for crimping a prosthetic implant on a target crimping location relative to a delivery apparatus. The alignment guide can include an outer wall defining a central channel configured to receive a delivery apparatus for a prosthetic implant, a coupling portion coupled to the proximal end portion of the outer wall and disposed radially outward from the central channel configured to releasably secure the alignment guide to a distal side portion of a crimping device, and one or more retention elements configured to restrict axial and/or radial movement of the delivery apparatus relative to the alignment guide. The assembly can also include an implant alignment device and a crimping device.

Description

DEVICES AND METHODS FOR CRIMPING PROSTHETIC IMPLANTS

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Nos. 63/699,665, filed September 26, 2024, and 63/641,871, filed May 2, 2024, which are incorporated by reference herein.

FIELD

[0002] The present disclosure relates to apparatuses, systems, and methods for crimping a prosthetic implant on 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 heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.

SUMMARY

[0004] Described herein are prosthetic implants, delivery apparatus, and methods for crimping prosthetic implants on to delivery apparatus. The disclosed prosthetic implants, delivery apparatus, and methods can, for example, automate and/or improve accuracy in the crimping process and/or the resulting placement of the implant. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic implants and their delivery apparatus. [0005] An assembly for crimping a prosthetic implant on a delivery apparatus can comprise: a crimping device comprising a central channel, a proximal side portion, and a distal side portion, wherein the central channel extends from the proximal side portion to the distal side portion; an alignment guide coupled to the distal side portion of the crimping device and configured to receive a distal end portion of a delivery apparatus; and an implant alignment device coupled to the proximal side portion of the crimping device and configured to position a prosthetic implant within the central channel of the crimping device.

[0006] In some examples, the alignment guide comprises a central channel configured to receive a distal end portion of a delivery apparatus. In some examples, the alignment guide comprises one or more retention members configured to retain the distal end portion of the delivery apparatus.

[0007] In some examples, the implant alignment device has a coupling member positioned on an outer diameter of the implant alignment device which is sized and shaped to fit within a slot in the crimping device, wherein crimping the prosthetic implant results in the coupling member sliding out of and detaching from the crimping device.

[0008] In some examples, the prosthetic implant comprises a prosthetic valve. In some examples, the prosthetic implant comprises a stent.

[0009] In some examples, an assembly comprises one or more of the components recited in examples 1-6 below.

[0010] An alignment guide for a delivery apparatus can comprise: an outer wall defining a central channel and a longitudinal axis, wherein the central channel is configured to receive a delivery apparatus for a prosthetic implant; a coupling portion coupled to a proximal end portion of the outer wall and disposed radially outward from the central channel and configured to releasably secure the alignment guide to a distal side portion of a crimping device; and one or more retention elements extending from the coupling portion and configured to engage a distal end portion of the delivery apparatus and restrict axial and/or radial movement of the delivery apparatus relative to the alignment guide.

[0011] In some examples, the one or more retention elements comprises a support portion configured to receive a distal end portion of the delivery apparatus, wherein the support portion is configured to retain the distal end portion of the delivery apparatus in a radial direction while allowing rotational motion around a central axis. In some examples, the alignment guide further comprises a distal wall coupled to a distal end portion of the outer wall, and the one or more retention elements comprises an aperture in the distal wall. In some examples, the one or more retention elements are configured to restrict axial movement. In some examples, the one or more retention elements comprises one or more retention arms wherein each of the one or more retention arms is configured to capture the delivery apparatus and restricts axial movement. In some examples, the one or more retention arms are further configured to restrict radial movement. In some examples, the one or more retention arms comprises two retention arms. In some examples, the delivery apparatus comprises an alignment cover and the one or more retention arms are configured to engage the alignment cover.

[0012] In some examples, the coupling portion comprises one or more coupling members configured to be inserted into a corresponding coupling portion of the crimping device. In some examples, the coupling members are configured to be twisted around the longitudinal axis to couple with the crimping device.

[0013] In some examples, the distal end portion of the delivery apparatus comprises a cylindrical stylet and wherein the stylet is sized and shaped to fit into the aperture in the distal wall. In some examples, the delivery apparatus further comprises an alignment cover with an annular groove and the one or more retention elements are sized and shaped to couple with the annular groove.

[0014] In some examples, an alignment guide comprises one or more of the components recited in examples 7-18 below.

[0015] An assembly for crimping a prosthetic implant on a delivery apparatus can comprise: a crimping device; an alignment guide coupled to the distal side portion of the crimping device; and an implant alignment device coupled to a proximal side portion of the crimping device.

[0016] In some examples, an assembly comprises one or more of the components recited in examples 7-22 below.

[0017] An implant alignment device can comprise: a coupling portion configured to couple with a crimping device; a support portion coupled to the coupling portion, the support portion tapers from a wider end that is disposed adjacent to the coupling portion to a narrower end portion, wherein the support portion comprises an outward facing support surface that is configured to receive a prosthetic implant thereon; and a central channel defining a longitudinal axis and extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus therethrough.

[0018] In some examples, the coupling portion comprises a coupling member, wherein the coupling member is positioned radially outward from the support portion and sized and shaped to within a slot in the crimping device.

[0019] In some examples, the assembly further comprises one or more one or more axially extending alignment members, each alignment member extending axially from the wider end of the support portion, wherein the one or more axially extending alignment members extend over the narrower end portion of the support portion, each alignment member comprising a free end configured to abut an end of the prosthetic implant.

[0020] In some examples, an implant alignment device configured to be releasably coupled to a crimping device comprises: a coupling portion configured to be releasably coupled to a proximal side portion of the crimping device; and a support portion with one or more support members, wherein each support member comprises an outward facing support surface, wherein the support surfaces are configured to be inserted into a prosthetic implant to support the prosthetic implant, and wherein the support members are configured to deflect radially inward during crimping of the prosthetic implant by the crimping device.

[0021] In some examples, the coupling portion is configured to be inserted into a crimper aperture of the crimping device.

[0022] In some examples, the implant alignment device further comprises a central channel extending through the coupling portion and the support portion, wherein the central channel is configured to receive a delivery apparatus for the prosthetic implant therethrough, and wherein the coupling portion defines a lumen that forms a portion of the central channel.

[0023] In some examples, the coupling portion comprises a first end, a second end, and a cylindrical wall extending between the first end and the second end.

[0024] In some examples, the coupling portion comprises a plurality of radial projections extending radially away from the cylindrical wall and configured to mate with corresponding features of the crimping device to restrict rotation of the implant alignment device relative to the crimping device.

[0025] In some examples, the cylindrical wall comprises a cutout such that the cylindrical wall extends only partially around a central axis of the implant alignment device. [0026] In some examples, the cutout is configured to permit a portion of a delivery apparatus that extends through a central channel of the implant alignment device to pass through the cutout to permit the implant alignment device to be removed from the delivery apparatus.

[0027] In some examples, the coupling portion comprises a plurality of radial projections extending radially away from the cylindrical wall, and wherein the cutout is formed in one of the plurality of radial projections.

[0028] In some examples, each support member comprises a support body that at least partially defines a support ledge that is configured to engage a portion of the prosthetic implant to define an axial position of the prosthetic implant relative to the implant alignment device when the prosthetic implant is supported on the support surfaces.

[0029] In some examples, each support member is configured to transition between a supporting configuration, in which the support surfaces of the support members are positioned to support the prosthetic implant thereon, and an ejection configuration, in which the support surfaces are radially deflected toward a central axis of the implant alignment device to facilitate ejection of the implant alignment device from the crimping device.

[0030] In some examples, each support member is biased toward the supporting configuration.

[0031] In some examples, the support members are configured to engage one another when in the ejection configuration.

[0032] In some examples, each support member comprises one or both of an alignment tab and an alignment receiver, and wherein, when the support members are in the ejection configuration, each alignment tab is received within a corresponding alignment receiver.

[0033] In some examples, when each support member is in the supporting configuration, the support surface is angled relative to a direction parallel to the central axis by a support angle that is one or more of at least 1 degree, at least 3 degrees, at least 5 degrees, at most 7 degrees, at most 4 degrees, or at most 2 degrees.

[0034] In some examples, when each support member is in the ejection configuration, the support surface is angled relative to a direction parallel to the central axis by an ejection angle that is one or more of at least 10 degrees, at least 13 degrees, at least 15 degrees, at least 20 degrees, at most 25 degrees, at most 17 degrees, at most 14 degrees, or at most 12 degrees. [0035] In some examples, each support member comprises an attached end and a free end disposed axially away from the attached end, and wherein the free end is configured to deflect radially inward during crimping of the prosthetic implant by the crimping device.

[0036] In some examples, the support portion comprises an annular projection that extends distally from the coupling portion, and wherein the attached end of each support member is attached to and extends distally from the annular projection.

[0037] In some examples, the attached end of each support member is attached to and extends distally from the coupling portion.

[0038] In some examples, each support member comprises a flexure region proximate to the attached end, and wherein the flexure region is configured such that the support member bends within the flexure region relative to the coupling portion to move the free end radially toward a central axis of the implant alignment device in response to a radially inward directed force applied to the support surface.

[0039] In some examples, the flexure region comprises an indentation configured to facilitate flexure of the support member in the flexure region.

[0040] In some examples, each support member comprises an engagement feature configured to enhance engagement between the support member and the implantable device.

[0041] In some examples, each engagement feature protrudes radially away from the support surface of the corresponding support member.

[0042] In some examples, each engagement feature comprises one or more of a circumferentially extending feature, an axially extending feature, a protrusion, a plurality of protrusions, or a texture surface feature.

[0043] In some examples, an implant alignment device comprises one or more of the components recited in examples 23-45 below.

[0044] An alignment guide for a delivery apparatus can comprise: a guide shaft; a central channel extending through the guide shaft and defining a longitudinal axis; and a coupling portion, wherein the central channel is configured to receive a distal end portion of the delivery apparatus while the delivery apparatus is inserted into a crimping device to axially align the delivery apparatus relative to the crimping device. [0045] In some examples, the alignment guide further comprises a guide wall extending between the guide shaft and the coupling portion, wherein the guide wall is ramped to guide the delivery apparatus radially inward toward the central channel.

[0046] In some examples, the coupling portion comprises an outer wall that is disposed radially outward from the central channel, and wherein the guide wall extends to a proximal end region of the outer wall.

[0047] In some examples, the coupling portion comprises an alignment member configured to engage the crimping device and to rotationally align the coupling portion with the crimping device.

[0048] In some examples, the alignment member comprises an axially extending projection that extends proximally from a distal end region of an outer wall of the coupling portion toward a proximal end region of the outer wall.

[0049] In some examples, the guide shaft comprises an inner wall that at least partially defines the central channel, and wherein a distal end region of the inner wall comprises an engagement surface configured to engage a portion of the delivery apparatus to restrict further axial translation of the delivery apparatus in the distal direction.

[0050] In some examples, the guide shaft comprises a distal aperture through which a distal end region of the delivery apparatus extends when the delivery apparatus is axially aligned with the alignment guide.

[0051] In some examples, the guide shaft comprises a viewing cutout that extends to the central channel to permit visual inspection of one or more components of the delivery apparatus within the central channel.

[0052] In some examples, the viewing cutout extends fully to a distal end of the guide shaft, and wherein the guide shaft extends only partially around the longitudinal axis at the distal end.

[0053] In some examples, the viewing cutout is spaced apart from a distal end of the guide shaft, and wherein the guide shaft extends fully around the longitudinal axis at the distal end.

[0054] In some examples, the guide shaft comprises an alignment feature configured to be axially aligned with a corresponding feature of the delivery apparatus when the delivery apparatus is axially aligned with the alignment guide. [0055] In some examples, the alignment feature comprises a groove defined in the guide shaft.

[0056] In some examples, the alignment feature comprises one or more of a visual indicator, a printed marking, or a raised feature.

[0057] In some examples, an alignment guide comprises one or more of the features recited in examples 46-58 below.

[0058] An assembly for crimping a prosthetic implant on a delivery apparatus can comprise: a crimping device; an implant alignment device; and an alignment guide.

[0059] In some examples, an assembly comprises one or more of the components recited in examples 23-58 below.

[0060] A method of mounting a prosthetic implant to a delivery apparatus can comprise: positioning a prosthetic implant comprising an annular frame onto an implant alignment device; inserting a balloon catheter of the prosthetic implant delivery apparatus within a central channel of the implant alignment device and within a central passage of the prosthetic implant; positioning the balloon catheter, the prosthetic implant, and a distal end portion of the implant alignment device within a central channel of a crimping device and coupling the implant alignment device to a proximal side portion of the crimping device, such that the prosthetic implant is axially aligned with compression elements of the crimping device; and advancing the balloon catheter through the crimping device and positioning the balloon catheter in an alignment guide that is coupled to a distal side portion of the crimping device.

[0061] In some examples, the method further comprises, prior to positioning the prosthetic implant onto the implant alignment device, operatively coupling a crimp alignment tool to a distal portion of the delivery apparatus.

[0062] In some examples, the prosthetic implant comprises one or more commissures and positioning the prosthetic implant onto the implant alignment device comprises aligning the one or more commissures with one or more markings one the implant alignment device.

[0063] In some examples, the method further comprises after inserting the balloon catheter within the central channel of the alignment guide, capturing the crimp alignment tool with one or more retention members. In some examples, the method further comprising crimping an annular frame of the prosthetic implant, resulting in a crimped prosthetic implant. [0064] In some examples, the step of crimping the annular frame of the prosthetic implant comprises one or more crimping motions, wherein each of the crimping motions has the result of ensuring the annular frame is properly crimped.

[0065] In some examples, crimping the annular frame results in the implant alignment device being ejected from the crimping device. In some examples, the compression elements are a plurality of circumferentially arrayed nesting jaws.

[0066] In some examples, the method further comprises removing the balloon catheter and the crimped prosthetic implant, which is now disposed on the balloon catheter, from the alignment guide, crimping device, and implant alignment device.

[0067] In some examples, the method further comprises inserting the delivery apparatus into a patient’s vasculature.

[0068] In some examples, a method comprises one or more of the steps recited in examples 60-69 below.

[0069] A method of mounting a prosthetic implant to a delivery apparatus can comprise: positioning the prosthetic implant onto an implant alignment device; coupling the implant alignment device to a proximal side portion of a crimping device to position the prosthetic implant within a crimper aperture of the crimping device; coupling an alignment guide to a distal side portion of the crimping device; inserting the delivery apparatus through a central channel of the implant alignment device and through the crimper aperture; inserting a portion of the delivery apparatus within the alignment guide; and actuating the crimping device to crimp the prosthetic implant onto the delivery apparatus.

[0070] In some examples, the actuating the crimping device causes the implant alignment device to be ejected from the proximal side portion of the crimping device while the prosthetic implant remains within the crimper aperture.

[0071] In some examples, the implant alignment device comprises a support portion with one or more support members, wherein each support member comprises an outward facing support surface that supports the prosthetic implant when the prosthetic implant is positioned on the implant alignment device, and wherein the actuating the crimping device causes the support members to deflect radially inward. [0072] In some examples, a method further comprises removing the implant alignment device from the delivery apparatus while the delivery apparatus is positioned within the crimper aperture.

[0073] In some examples, the implant alignment device comprises a cylindrical wall that defines a cutout such that the cylindrical wall extends only partially circumferentially around a central axis of the implant alignment device, and wherein the removing the implant alignment device from the delivery apparatus comprises passing a portion of the delivery apparatus through the cutout.

[0074] In some examples, the inserting the portion of the delivery apparatus within the alignment guide comprises positioning the delivery apparatus in a predetermined axial position relative to the alignment guide.

[0075] In some examples, the alignment guide comprises a guide shaft that at least partially defines a central channel, and wherein the inserting the portion of the delivery apparatus within the alignment guide comprises advancing the delivery apparatus through the central channel.

[0076] In some examples, the alignment guide comprises an alignment feature, and wherein the inserting the portion of the delivery apparatus within the alignment guide comprises positioning the delivery apparatus relative to the alignment guide such that a portion of the delivery apparatus is axially aligned with the alignment feature.

[0077] In some examples, a method further comprises inserting the delivery apparatus into a patient’s vasculature.

[0078] In some examples, a method comprises one or more of the steps recited in examples 70-78 below.

[0079] 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 [0080] FIGS. 1A-1B are perspective views illustrating components of a prosthetic implant preparation assemblies according to one example.

[0081] FIG. 2 is a detail perspective view of an example of a crimp alignment tool installed on a delivery apparatus.

[0082] FIGS. 3A-3C depict different aspects of an implant alignment device according to one example.

[0083] FIGS. 4A-4C depict different aspects of an alignment guide according to one example.

[0084] FIG. 5 is a partial cross-sectional view of a crimper assembly with an implant alignment device and an alignment guide from the top down.

[0085] FIG. 6 is a partial cross-sectional view of a crimper assembly with an implant alignment device and an alignment guide from the front of the crimper assembly.

[0086] FIGS 7A-7C depict different aspects of an alignment guide according to another example.

[0087] FIGS. 8A-8B depict different aspects of an alignment guide according to another example.

[0088] FIG. 9 depicts an example of a prosthetic heart valve that can be implanted using any of the delivery apparatuses disclosed herein.

[0089] FIGS. 10A-10C depict different aspects of an implant alignment device according to another example.

[0090] FIGS. 11A-11C are schematic cross-sectional views depicting operation of the implant alignment device of FIGS. 10A-10C in conjunction with a crimping device according to an example.

[0091] FIGS. 12A-12C depict different aspects of an implant alignment device according to another example.

[0092] FIG. 13 depicts an implant alignment device supporting a prosthetic heart valve according to an example.

[0093] FIGS. 14A-14D depict different aspects of an alignment guide according to another example. [0094] FIG. 15 depicts the alignment guide of FIGS. 14A-14D operatively coupled to a first side portion of a crimping device according to an example.

[0095] FIGS. 16A-16C depict different aspects of a configuration in which the implant alignment device of FIGS. 10 A- 10C and an alignment guide are operatively coupled to a crimping device through which a delivery apparatus is inserted according to an example.

DETAILED DESCRIPTION

General Considerations

[0096] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0097] 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.

[0098] 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. [0099] 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.

[0100] As used herein, the term “operatively coupled,” as used to describe a configuration and/or relationship between two or more components, is intended to refer to a configuration and/or relationship in which the components are directly or indirectly coupled to one another in a manner consistent with the structures and/or functions disclosed herein. For example, a pair of components may be described as being operatively coupled to one another when such components are coupled to one another in a manner that is operative to produce the structural configurations and/or functional properties disclosed herein.

[0101] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”

Introduction to the Disclosed Technology

[0102] Disclosed herein are various systems, apparatuses, methods, etc., including prosthetic implant preparation assemblies that can be used in conjunction with implantable medical devices, for example prosthetic implants (such as transcatheter heart valves (THV)). The various systems, apparatuses, methods, etc. disclosed herein generally are directed to preparing the implantable prosthetic implants for delivery through a patient’s vasculature to a target implantation site. In particular, the present disclosure pertains to examples in which the implantable prosthetic implant comprises an annular frame that can be crimped to a constricted diameter for passage through the patient’s vasculature and subsequently expanded to an operative diameter by an inflatable balloon of the delivery apparatus.

[0103] Before crimping, a balloon-expandable implantable prosthetic implant is typically placed over an expandable balloon on a catheter shaft. In cases where the implant was manufactured in its fully crimped diameter, the implant is expanded and then crimped on the balloon. In order to ensure that the balloon reliably expands the frame of the implant after the implant reaches a target implantation site in the patient’s vasculature, it may be beneficial to ensure that the crimping process results in the implant being crimped accurately onto the balloon at a repeatably precise location. The proper placement of the crimped prosthetic implant on the target crimping location can help to ensure a predictable deployment. An accurate and precise crimp at the target crimping location of the balloon helps to ensure repeatable and reliable implant expansion and deployment shape of the frame. It also may be beneficial to ensure that the crimping process crimps the frame of the implant evenly and without damage to the implant while ensuring that the crimped diameter of the implant is sufficiently small to traverse the patient’s vasculature. The present disclosure addresses these needs.

[0104] The present disclosure generally is directed to examples of implantable valve preparations assemblies and to examples of methods of utilizing various components of prosthetic valve preparation assemblies to prepare an implantable prosthetic valve for delivery to a target implantation site.

[0105] As shown in FIGS. 1A-1B, and as discussed in more detail below, a prosthetic implant preparation assembly 10 can comprise a prosthetic valve 300, a delivery apparatus 200 configured to deliver a prosthetic implant, such as prosthetic valve 300, to the target implantation site, and a crimping device 100 for crimping the prosthetic valve 300 around the delivery apparatus 200.

[0106] As shown in FIG. 2, and as discussed in more detail below, the prosthetic implant preparation assembly 10 further can comprise a crimp alignment tool 400 (also referred to as an “alignment cover”) configured to facilitate crimping the implantable prosthetic implant at a target crimping location relative to the delivery apparatus 200.

Exemplary Implantable Prosthetic Valve

[0107] Various prosthetic implants are described and/or discussed herein. While specific examples of prosthetic heart valves are discussed herein, general structures, methods of manufacture, and methods of use of various implantable prosthetic implants that can be adapted for use with the apparatuses and methods disclosed herein are described in at least U.S. Pat. No. 9,393,110, U.S. Pat. No. 10,195,025, U.S. Pat. No. 11,013,600, and U.S. Pat. No. 11 ,185,406, the disclosures of which are incorporated by reference herein in their entirety.

[0108] FIGS. 1A illustrates an example of a prosthetic implant, in the depicted example, the prosthetic implant is as prosthetic valve 300. As used herein, the implantable prosthetic implant is an implantable prosthetic valve 300 (also may referred to as a “prosthetic valve” and/or a “transcatheter heart valve (THV)”).

Examples of a Delivery Apparatus

[0109] Prosthetic implant delivery apparatus according to examples, and/or components thereof, are shown in FIGS. 1A and 2. While specific examples of delivery apparatus are discussed herein, general structures and methods of use of various prosthetic implant delivery apparatus that can be adapted for use with the apparatuses and methods disclosed here are described in at least U.S. Pat. No. 9,061,119 and U.S. Pat. No. 9,339,384, the disclosures of which are incorporated by reference herein in their entirety.

[0110] As illustrated in FIGS. 1A and 2, a delivery apparatus 200 can comprise a steerable guide catheter 210 and a balloon catheter 220 extending through the guide catheter 210. As used herein, the guide catheter 210 (also may be referred to as a “flex catheter” and/or a “main catheter). The use of the term “guide catheter” should be understood, however, to include flex or main catheters, as well as other catheters that do not have the ability to flex or guide through a patient’s vasculature. In some examples, such as in the illustrated example, the guide catheter 210 and the balloon catheter 220 are adapted to slide longitudinally relative to each other to facilitate delivery and positioning of the implantable prosthetic valve 300 at the target implantation site in the patient's body.

[0111] As shown in FIG. 1A, the guide catheter 210 includes a handle portion 212 and an elongated guide catheter shaft, or tube, 214 extending from the handle portion 212. The balloon catheter 220 includes a proximal portion 222 adjacent to the handle portion 212 and a balloon catheter shaft 226 that extends from the proximal portion 222 and through the handle portion 212 and the guide catheter shaft 214. The delivery apparatus 200 additionally comprises an inflatable balloon 230 mounted on the balloon catheter 220 at a distal portion 224 of the balloon catheter 220, which is opposite the proximal portion 222. As discussed in more detail herein, the delivery apparatus 200 generally is configured such that the implantable prosthetic valve 300 is mounted to the delivery apparatus 200 in a crimped state to prepare the delivery apparatus 200 and the implantable prosthetic valve 300 for insertion into a patient’ s vasculature.

[0112] In some examples, as illustrated in FIG. 2, the delivery apparatus 200 comprises a stylet 250. As illustrated in FIG. 2, the stylet 250 can comprise a cylindrical stylet shaft 252 (e.g., a rigid and/or metallic shaft) that is configured to extend through the distal aperture 422 of the crimp alignment tool 400 (discussed below).

Examples of a Crimp Alignment Tool

[0113] As discussed above, it generally is desirable to ensure that the implantable prosthetic valve 300 is precisely and reliably positioned at the target crimpling location relative to the inflatable balloon 230 prior to fully crimping the implantable prosthetic valve 300 onto the inflatable balloon 230. Accordingly, and as shown in FIG. 2 the prosthetic implant preparation assembly 10 can comprise a crimp alignment tool 400 that is configured to facilitate positioning the implantable prosthetic valve 300 at the target crimping location.

[0114] The crimp alignment tool 400 can be utilized to help ensure that the implantable prosthetic valve 300 is positioned at a predetermined axial position relative to one or more components of the delivery apparatus 200 that corresponds to the target crimping location. Specifically, and as discussed in more detail herein, the crimp alignment tool 400 can be configured to engage each of the delivery apparatus 200 and the implantable prosthetic valve 300 to position the implantable prosthetic valve 300 at the target crimping location relative to the delivery apparatus 200.

[0115] The alignment configuration of the crimp alignment tool 400 may be described and/or defined with reference to a relative orientation and/or a mechanical engagement between the crimp alignment tool 400 and the delivery apparatus 200. In particular, and as described in more detail herein, the crimp alignment tool 400 can comprise a crimp alignment tool distal end 420 that is configured to engage the distal portion of the delivery apparatus 200 to define the alignment configuration and/or to retain the crimp alignment tool 400 in the alignment configuration.

[0116] When the crimp alignment tool 400 is in the alignment configuration relative to the delivery apparatus 200, the position of the crimp alignment tool 400 may be utilized to place the implantable prosthetic valve 300 at the target crimping location. In particular, the crimp alignment tool 400 comprises a valve stop 412 positioned in a proximal region 410 of the crimp alignment tool 400.

[0117] The crimp alignment tool 400 may be configured to engage the delivery apparatus 200 in the alignment configuration in any of a variety of manners. In some examples, the crimp alignment tool 400 can be moved longitudinally (e.g., via axial translation) onto the distal portion of the delivery apparatus 200 to operatively couple the crimp alignment tool 400 to the delivery apparatus 200. Similarly, in such examples, the crimp alignment tool 400 may be removed from the delivery apparatus 200 by longitudinally sliding the crimp alignment tool 400 off of and away from the delivery apparatus 200.

[0118] In some examples, the crimp alignment tool 400 can be configured to restrict and/or prevent inadvertent removal of the crimp alignment tool 400 from the delivery apparatus 200. For example, the crimp alignment tool 400 can be configured such that, when the crimp alignment tool 400 is in the alignment configuration, the crimp alignment tool 400 is at least partially restricted from being removed from the delivery apparatus 200. As more specific examples, the crimp alignment tool 400 may be configured to engage the distal portion of the delivery apparatus in a friction-fit engagement, a mechanical engagement, a latching engagement, a snap-fit engagement, etc.

[0119] In some examples, positioning the crimp alignment tool 400 in the alignment configuration may produce a tactile and/or auditory confirmation, such as a snap, a pop, a bump, etc., that indicates that the crimp alignment tool has reached the alignment configuration. Such a tactile and/or auditory confirmation can be the result, for example, of forming a mechanical coupling, such as engaging a latch, engaging/receiving a detent, engaging/receiving a projection or a groove, etc.

[0120] The crimp alignment tool 400 may be configured to receive and/or engage any suitable portion of the delivery apparatus 200 for defining, and/or for retaining the crimp alignment tool 400 in, the alignment configuration. In some examples, and as illustrated in FIG. 2 the crimp alignment tool 400 is configured such that the stylet 250 of the delivery apparatus 200 engages the crimp alignment tool distal end 420 when the crimp alignment tool 400 is in the alignment configuration. In such examples, the crimp alignment tool 400 can be configured such that an inner diameter of the crimp alignment tool 400 mates with an outer diameter of the stylet 250 when the crimp alignment tool 400 is in the alignment configuration.

[0121] In particular, and as discussed above, the stylet 250 may be formed of a material that is rigid and thus may provide a reliable point of reference for measuring an axial distance relative to the inflatable balloon 230. For example, when the stylet 250 is formed of a relatively rigid material, such rigidity may facilitate establishing a precise and/or well-defined positional relationship between the stylet 250 and the crimp alignment tool 400. [0122] In some examples, and as illustrated at least in FIG. 2, the crimp alignment tool distal end 420 comprises a distal aperture 422 that receives the distal portion of the delivery apparatus 200 (e.g., the stylet 250) when the crimp alignment tool is in the alignment configuration. In some such examples, the crimp alignment tool 400 can be configured such that the stylet 250 extends at least partially through the distal aperture 422 when the crimp alignment tool 400 is in the alignment configuration. In this manner, the engagement between the distal aperture 422 and the stylet 250 may at least partially define the alignment configuration. For example, the stylet 250 can be at least partially conical in shape such that the stylet 250 engages the distal aperture 422 (i.e., the portion of the crimp alignment tool 400 that defines the distal aperture 422) only when the stylet 250 is in a precise and predetermined axial position relative to the crimp alignment tool 400.

[0123] The crimp alignment tool 400 can comprise an engagement feature 430. The engagement feature 430 may comprise and/or be any suitable feature, such as features that mates with another and/or mechanically engages another to restrict and/or prevent axial translation of the crimp alignment tool 400 relative to an alignment guide, such as alignment guide 600 as described below. As a more specific example, and as illustrated in FIG. 2, the engagement feature 430 can comprise an annular groove 432.

[0124] In some examples, the crimp alignment tool 400 can comprise a distal alignment indicator 424 in the form of one or more features for providing a visual verification that the crimp alignment tool 400 is in the alignment configuration. For example, in some examples, and as illustrated in FIG. 2, the distal alignment indicator 424 comprises a window 426 that permits visual inspection of the delivery apparatus 200 through the crimp alignment tool 400. That is, in such examples, the window 426 can be an opening and/or an aperture formed in a side wall of the crimp alignment tool 400 such that a portion of the delivery apparatus 200 that is received within the crimp alignment tool 400 is visible through the window 426.

[0125] In some examples, the crimp alignment tool 400 is configured such that, when the crimp alignment tool is in the alignment configuration, a component of the delivery apparatus is axially aligned with a distal edge of the window 426 and/or with a proximal edge of the window 426. In some examples, the window 426 is positioned such that a proximal edge of the stylet 250 is axially aligned with a distal edge of the window 426 when the crimp alignment tool 400 is in the alignment configuration. In this manner, the user can verify that the crimp alignment tool 400 is in the alignment configuration by visually verifying that the proximal edge of the stylet 250 is axially aligned with the distal edge of the window 426. [0126] The crimp alignment tool 400 may be configured to engage the implantable prosthetic valve 300 to position the implantable prosthetic valve 300 at the target crimping location in any suitable manner. In some examples, the crimp alignment tool 400 comprises and/or terminates at a crimp alignment tool proximal end 414 that defines the valve stop 412. This is not required of all examples of the crimp alignment tool, however. For example, it additionally is within the scope of the present disclosure that the crimp alignment tool 400 is configured to at least partially axially overlap with the implantable prosthetic valve 300 to position the implantable prosthetic valve 300 at the target crimping location.

Examples of a Crimper Assembly

[0127] As discussed herein, the prosthetic implant preparation assembly 10 generally comprises a crimping device 100 for crimping the implantable prosthetic valve 300 onto the inflatable balloon 230. Crimper assemblies according to some examples, and/or components thereof, are shown in FIGS. 1A-1B and 5-6. While specific examples of crimper assemblies are discussed herein, general structures and methods of use of various crimper assemblies that can be adapted for use with the apparatuses and methods disclosed here are described in at least U.S. Pat. No. 7,530,253, the disclosure of which is incorporated by reference herein in its entirety.

[0128] As illustrated at least in FIGS. 1 A-1B, a crimping device 100 can comprise a base 112, a housing 110 fixedly mounted to the base 112, and a plurality of compression elements. In the depicted example the plurality of compression elements comprises a plurality of circumferentially arrayed nesting jaws 114 supported within the housing 110. More specifically, the housing 110 defines a crimper assembly central axis 101, and the jaws 114 are radially moveable within the housing 110 toward and away from the crimper assembly central axis 101. The jaws 114 collectively define a crimper aperture 130 (also referred to as a “central channel”) that varies in diameter as the jaws 114 move toward and away from the crimper assembly central axis 101 .

[0129] The crimping device 100 further comprises an actuator handle 120 configured to be manually actuated to move the jaws 114 to vary the diameter of the crimper aperture 130. Specifically, in the illustrated example, the actuator handle 120 can be pivoted relative to the housing 110 in a first direction to move the jaws 114 radially toward the crimper assembly central axis 101, and the actuator handle 120 can be pivoted relative to the housing 110 in a second direction that is opposite the first direction to move the jaws 1 14 radially away from the crimper assembly central axis 101. Accordingly, when the implantable prosthetic valve 300 is positioned within the crimper aperture 130, actuating the actuator handle 120 to decrease the diameter of the crimper aperture 130 can operate to crimp the implantable prosthetic valve 300.

[0130] The crimping device 100 may comprise a first side portion 102 and a second side portion 104 and the crimper aperture 130 may extend from an opening on the first side portion 102 to an opening on the second side portion 104. In some examples, such as in the examples of FIGS. IB and 5-6, the first side portion 102 also may be referred to as a proximal side portion 102 and/or as a proximal face 102. In such examples, the second side portion 104 also may be referred to as a distal side portion 104 and/or as a distal face 104. In other examples, such as in the examples of FIGS. 11A-11C and 15-17, the first side portion 102 also may be referred to as a distal side portion 102 and/or as a distal face 102. In such examples, the second side portion 104 also may be referred to as a proximal side portion 104 and/or as a proximal face 104.

[0131] The first side portion 102 and/or the second side portion 104 may comprise one or more coupling mechanisms. In some examples, as illustrated in FIG. 1A, the first side portion 102 may comprise a cut-out portion 108 (also referred to as a “recess”). In some examples, as illustrated in FIG. IB, the second side portion 104 may comprise one or more slots 106. In the depicted example, there are three slots 106 which are configured to couple with a corresponding mechanism which may be turned, such as in a clockwise direction to secure to the crimping device 100. In some examples, the first side portion 102 and/or the second side portion 104 may comprise other coupling mechanisms such as a recess, snap-in feature, alternate alignment feature, or a combination of any of these that is configured to mate with a corresponding mating interface on a component such as an implant alignment device or an alignment guide, as described in detail below.

[0132] In some examples, the crimper aperture 130 extends along a crimper aperture length, as measured along a direction parallel to the crimper assembly central axis 101, that is equal to or greater than a length of the implantable prosthetic valve 300. Accordingly, in such examples, the implantable prosthetic valve 300 may be positioned fully within the crimper aperture 130 such that the crimping device 100 exerts a crimping force evenly across the full length of the implantable prosthetic valve 300. [0133] When the crimping device 100 is utilized to fully crimp the implantable prosthetic valve 300 to the delivery configuration, the implantable prosthetic valve 300 can engage the inflatable balloon 230 sufficiently tightly that the implantable prosthetic valve 300 is restricted from translating relative to the inflatable balloon 230. Thus, prior to fully crimping the implantable prosthetic valve 300 upon the inflatable balloon 230, it is desirable to ensure that the implantable prosthetic valve 300 is properly positioned at the target crimping location.

[0134] As used herein, the term “target crimping location” is intended to refer to any suitable axial location and/or range of locations along the inflatable balloon 230 at which the implantable prosthetic valve 300 is to be operatively coupled. As an example, the target crimping location may include and/or be an axial position along the inflatable balloon 230 at which a distal end of the implantable prosthetic valve 300 is to be located when the implantable prosthetic valve 300 is properly crimped to the inflatable balloon 230. As another example, the target crimping location may include and/or be an axial position along the inflatable balloon 230 at which a proximal end of the implantable prosthetic valve 300 is to be located when then implantable prosthetic valve 300 is properly crimped to the inflatable balloon 230. As yet another example, the target crimping location may refer to a portion (e.g., an interval) of the length of the inflatable balloon 230 within which the implantable prosthetic valve 300 is to be positioned when the implantable prosthetic valve 300 is properly crimped to the inflatable balloon 230.

[0135] In some examples, it may be desirable to partially crimp the implantable prosthetic valve 300 to an intermediate configuration prior to fully crimping the implantable prosthetic valve 300 to the delivery configuration. Specifically, in such examples, the implantable prosthetic valve 300 in the intermediate configuration may be sized (e.g., in inner diameter) to engage the delivery apparatus 200 and/or the inflatable balloon 230 such that the implantable prosthetic valve 300 may be manually translated relative to the inflatable balloon 230, but such that the implantable prosthetic valve 300 is at least partially restricted from inadvertent translation relative to the inflatable balloon 230. In this manner, crimping the implantable prosthetic valve 300 to the intermediate configuration and subsequently positioning the implantable prosthetic valve 300 at the target crimping location may ensure that the implantable prosthetic valve 300 remains at the target crimping location during the final crimping action. [0136] In some examples, crimping the implantable prosthetic valve 300 to the intermediate configuration or to the delivery configuration is accomplished by bringing the diameter of the crimper aperture 130 to a corresponding predetermined diameter. This in turn can be accomplished by mechanically limiting a range of motion of the actuator handle 120 during use of the crimping device 100.

[0137] More specifically, as illustrated in FIGS. 1A-1B the crimping device 100 can comprise a first crimp stop 150 and a second crimp stop 170, each of which may be utilized to define a respective range of motion of the actuator handle 120. The second crimp stop 170 can be fixedly coupled relative to the housing 110 during use of the crimping device 100, and the first crimp stop 150 can be selectively and operatively coupled to the second crimp stop 170. In particular, and as described in more detail herein, the first crimp stop 150 is configured to be mechanically coupled to the second crimp stop 170.

[0138] In some examples, the first crimp stop 150 and the second crimp stop 170 may be described as representing components of a crimp stop assembly 140 of the crimping device 100. In particular, FIG. 1A illustrates an example of a crimp stop assembly 140 that includes a first example of the first crimp stop 150 in combination with the second crimp stop 170.

[0139] When the first crimp stop 150 is operatively coupled to the second crimp stop 170, the first crimp stop 150 and the second crimp stop 170 collectively can define a partial range of motion of the actuator handle 120. That is, when the first crimp stop 150 is operatively coupled to the second crimp stop 170, the actuator handle 120 may be actuated to decrease the diameter of the crimper aperture 130 only until the actuator handle 120 engages the first crimp stop 150, at which point the actuator handle 120 is mechanically restricted and/or prevented from further actuation in this direction.

[0140] While specific examples of crimper assemblies and crimp stop assemblies are discussed herein, general structures and methods of use of crimper assemblies and various crimp stop assemblies that can be adapted for use with the apparatuses and methods disclosed here are described, for example, in International Pub. No. WO 2024/015433 Al, which is incorporated by reference herein in its entirety.

[0141] In some examples of delivery assemblies for transporting implantable prosthetic implants, the delivery apparatus is configured such that the implantable prosthetic implant is crimped onto a location that is proximal to, but removed from, the inflatable balloon. Such configurations may facilitate crimping the prosthetic implant to relatively small profile, thereby facilitating delivery of the prosthetic valve through the patient’ s vasculature. The use of such systems generally necessitates a separate step of repositioning the prosthetic implant upon the inflatable balloon while inside the patient’ s vasculature.

[0142] By contrast, mounting the prosthetic implant directly onto the inflatable balloon prior to entering the patient’s vasculature can improve the reliability and ease of implanting the prosthetic valve at the target implantation site. Accordingly, the apparatuses and methods disclosed herein can be used to crimp a prosthetic implant such as the implantable prosthetic valve 300 on the inflatable balloon 230 with a tightly compressed profile and at a precise target crimping location relative to the delivery apparatus 200. Manually aligning and mounting the prosthetic implant directly onto the inflatable balloon can present challenges and may require extensive training for users. It is desirable to increase automation in the valve crimping process, which in turn can increase accuracy and uniformity of the positioning of the crimped prosthetic implants while reducing the amount of training required for users to proficiently place the prosthetic implants. The proper placement of the crimped prosthetic implant at the target crimping location on the balloon can help to ensure a predictable deployment. An accurate and precise crimp at the target crimping location helps to ensure repeatable and reliable implant expansion and deployment shape of the frame. The crimping tools described herein can help to ensure repeatability and reliability.

[0143] Additional components may be used to increase automation and provide the benefits described above. In some examples, an implant alignment device, such as implant alignment device 500, for a prosthetic implant is used with the crimping device 100 described above. In some examples, an alignment guide, such as alignment guide 600, 700, or 700’, is used with the crimping device 100. In some examples, the implant alignment device 500, one of alignment guides 600, 700, or 700’, and the crimping device are all used together.

[0144] In some examples, an implant alignment device may be used to position a prosthetic implant, such as the prosthetic valve 300, at a preselected position within a crimping device, such as within the crimper aperture 130 of the crimping device 100. In some examples, the implant alignment device may have features which allow it to maintain the implant position before the crimping device is engaged and then to be ejected as the plurality of circumferentially arrayed nesting jaws 114 of the crimping device 100 come into contact with and then compress the implant. In some examples, the implant alignment device may comprise a cone shape which allows the implant alignment device to be ejected in a proximal direction as the implant is moved from an expanded state to a compressed state. [0145] FIGS. 3A-3C depict an exemplary implant alignment device 500 that is configured to receive a prosthetic implant thereon and couple to a crimping device. As shown in the side view of FIG 3A and the perspective view of FIG. 3C, the implant alignment device 500 includes a coupling portion 502, a support portion 504 (also referred to as an “implant support portion”), and one or more alignment members 506. The implant alignment device 500 also includes a central channel 508 extending through the coupling portion 502 and the support portion 504. The central channel 508 defines a central axis 501 and is sized and shaped to receive a delivery apparatus for the prosthetic implant therethrough (for example, delivery apparatus 200).

[0146] As described more fully below, the coupling portion 502 can be configured to releasably couple to a crimping device, such as the crimping device 100 shown in FIGS. 1A and 5-6. The support portion 504 can be configured to support a prosthetic implant (for example, prosthetic valve 300) on an outward facing support surface. In some examples, as shown in FIGS. 3A-3C, the support portion 504 is disposed at and extends distally from the coupling portion 502. In the depicted example, the support portion 504 tapers from a wider end that is disposed at the coupling portion to a narrower end portion. The narrower end can form a support surface 510, which is configured to be inserted into the prosthetic valve 300. The alignment members 506 can be used to space the prosthetic implant away from the coupling portion 502 and achieve a desired rotational alignment of the prosthetic valve relative to the coupling portion 502 and the crimping device. In some instances, the support portion 504 and coupling portion 502 (and the alignment members 506) can be formed (e.g., molded together) as one piece (as a unitary component).

[0147] As introduced above, the coupling portion 502 can be configured to be inserted into the crimper aperture 130 of the crimping device 100 (from the first side portion 102 of the crimping device 100) and couple to the crimping device 100.

[0148] The coupling portion 502 includes a first end 512 (proximal end) and a second end 514 (distal end). The coupling portion 502 defines a lumen that forms a portion of the central channel 508. A cylindrical wall 516 extends between the first end 512 and the second end 514 of the coupling portion 502. In some examples, the first end 512 can be referred to as a first end of the cylindrical wall 516 and the second end 514 can be referred to as the second end of the cylindrical wall 516. [0149] The coupling portion 502 includes a coupling member 522 that is configured to rotationally align the coupling portion 502 with the crimping device (e.g., crimping device 100, as shown in FIG. 6). The coupling member 522 can be circumferentially positioned on the coupling portion 502, proximate to the first end 512, such that it aligns the coupling portion 502 in a predetermined circumferential orientation within the crimper aperture 130 of the crimping device 100. The coupling member 522 can be configured (shaped) to mate with the cut-out portion 108 of the crimping device 100. In this manner, the coupling member 522 rotationally aligns the coupling portion 502, and thus the valve mounted on the support portion 504, with the crimping device 100. As a result of this coupling between the coupling member 522 and cut-out portion 108, the implant alignment device 500, and prosthetic valve mounted thereon, are prevented from rotating during crimping using the crimping device 100.

[0150] In some examples, as shown in FIGS. 3A-3C, the coupling member 522 is an axially extending projection that extends axially away from the first end 512 toward the second end 514 of the coupling portion 502. A free end 524 of the coupling member 522 can taper from the top or radially outward facing side to a point. In some instances, instead of tapering to a point, the free end 524 can taper to a narrower region (that is a little wider than shown in FIG. 3A and can be referred to as a tapered end). In some instances, the free end 524 may taper at both a top (radially outward facing side) and bottom (radially inward facing side) to a point or tapered end. The tapered free end 524 can allow for easier insertion into and coupling with the cut-out portion 108 in the crimping device.

[0151] In some examples, the coupling member 522 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 100. As one example, the crimping device can comprise a projection (in lieu of the cut-out portion 108) and the coupling member can comprise a slot (in lieu of the projection) configured to receive the projection of the crimping device.

[0152] The cylindrical wall 516 of the coupling portion 502 can include one or more retaining members 532 which can be configured as projections that prevent the coupling portion 502 from moving axially distally relative to the crimping device 100 after the implant alignment device 500 is attached to the crimping device 100. As a result, the implant alignment device 500 can be retained in a predetermined axial position within the crimping device 100, and relative to a delivery apparatus inserted into and coupled with the crimping device. As shown in FIG. 3B, the coupling portion 502 includes two retaining members 532 spaced apart from one another around the coupling portion 502.

[0153] As seen in FIGS. 3 A and 3B, in some examples, the implant alignment device 500 includes one or more axially extending alignment members 506 spaced circumferentially apart from one another around the implant alignment device 500. In some examples, the implant alignment device 500 includes three alignment members 506. In some examples, the implant alignment device 500 can include more or less than three alignment members 506 (e.g., one, two, four, etc.). Each alignment member 506 includes an attached end 548 and a free end 550 disposed axially away from the attached end 548. In some examples, the attached end 548 is disposed at (coupled to or formed together with) the second end 514 of the coupling portion 502. Each alignment member extends axially distally from the coupling portion 502, over a portion of the support portion 504 and terminates at a free end 550 adjacent to the support surface 510.

[0154] The support portion 504 can include one or more cut-outs or windows 552 disposed adjacent to each alignment member 506. In some examples, each window 552 can extend from the first end 548 to the support surface 510. The support portion 504 can have one window 552 for each alignment member 506 (e.g., three windows 552 in the example shown in FIGS. 3A-3C). As such, each window 552 can be configured to receive the free end 550 of a respective alignment member 506 therein. For example, the free end 550 of each alignment member 506 is configured to deflect or bend radially inward, into the corresponding window 552, in response to a radially inward directed force applied to its outer surface (e.g., during crimping with the crimping device 100).

[0155] In some examples, the free end 550 of each alignment member 506 is also configured to abut an end of the prosthetic valve and be axially aligned with a commissure of the prosthetic valve, when the prosthetic valve is mounted on the support surface 510. In some examples, the free end 550 of each alignment member 506 is configured to be inserted into a prosthetic valve 300 such that the free ends 550 of each alignment member 506 axially overlaps with the proximal end portion of the prosthetic valve 300.

[0156] In some examples, the alignment members 506 can be t-shaped. For example, a cross bar portion 554 of the t-shape can form between the attached end 548 and the free end 550 and a shaft of the t-shape can extend between the free end 550 and the attached end 348. [0157] In some examples, one or more alignment indicators 562 can be disposed on a distal face 564 at the distal end of the support portion 504. Each alignment indicator 562 can be axially aligned with a corresponding alignment member 506. As such, each alignment indicator 562 can be configured to indicate an axial location for a commissure of a prosthetic valve when mounted on the support surface 510. In some examples, the alignment indicators 562 can be arrows, lines, or variously shaped raised markings protruding from the distal face 564. In some examples, the alignment indicators 562 can be arrows, lines, or variously shaped markings in the distal face 564. For example, the alignment indicators 562 can be colored differently than a remainder of the implant alignment device 500. In some examples, the implant alignment device 500 may not include alignment indicators 562.

[0158] While specific examples of implant alignment device are discussed herein, general structures and methods of use of various implant alignment devices that can be adapted for use with the apparatuses and methods disclosed here are described in at least in U.S. Pub. No. 2023/0218415, which is incorporated by reference herein in its entirety.

[0159] In some examples, an alignment guide may be used to position a distal end portion of a prosthetic implant delivery apparatus at a preselected position within a crimping device. In some examples, the alignment guide may have features which are configured to engage a distal end portion of the delivery apparatus and restrict axial and/or radial movement of the delivery apparatus relative to the alignment guide. In some examples, positioning the prosthetic implant delivery apparatus at a preselected position ensures that the prosthetic implant is crimped at the target crimping location. This may have the benefit of increasing accuracy and increasing uniformity in the prosthetic implant crimping location on the delivery apparatus.

[0160] FIGS. 4A-4C depict different aspects of an alignment guide for a prosthetic implant delivery apparatus according to one example. The alignment guide is configured to receive a distal end portion of the delivery apparatus 200, which may be covered by the crimp alignment tool 400 (e.g., see FIG. 2), and position it at a preselected position within crimper aperture 130 of the crimping device 100 such that the target crimping location on the balloon 230 is positioned to receive the prosthetic valve 300. The alignment guide may comprise a central channel 602 defining a longitudinal axis 601, a coupling portion 606, a distal wall 608, and one or more retention elements. [0161] In the example depicted in FIGS. 4A-4C the central channel 602 is surrounded by the outer wall 604 and is at least partially defined by one or more retention arms 622 and an opening 626 in a midwall 624. The central channel is sized and shaped to receive the distal end portion of a delivery apparatus, such as the delivery apparatus 200, which in some examples may be covered by a cover, such as the crimp alignment tool 400.

[0162] The coupling portion 606 is disposed radially outward from the central channel and configured to releasably secure the alignment guide 600 to a second side portion of a crimping device, such as the crimping device 100. In some examples, the coupling portion 606 comprises a cylindrical wall which is sized and shaped to fit with the opening of the crimper aperture 130 on the second side portion of the crimping device 100. In some examples, the coupling portion 606 comprises one or more coupling members which are sized and shaped to fit with corresponding coupling portion of the crimping device 100. In some examples, the coupling portion may comprise one or more coupling members, these coupling members may comprise one or more fingers 612. In the depicted example, the coupling members comprises three fingers 612. Each finger 612 comprises a free end 614 and attached end 616 that are formed by one or more slots 618 in (through) the cylindrical wall. The free end 614 may include a protrusion 620 (or nub or bump) that protrudes radially outward from an outer surface of the free end 614 and is configured to couple with corresponding features on the second side portion of the crimping device 100, such as one or more slots 106. In some examples, the coupling portion 606 can have different configurations, such as a recess, snap-in feature, or alternate alignment features that are configured to mate with a corresponding mating interface of the crimping device 100. As one example, the coupling portion 606 may comprise one or recesses and the second side portion of the crimping device may comprise a corresponding one or more fingers.

[0163] In some examples, one or more retention elements extend distally from the coupling portion. The one or more retention elements may be configured to engage a distal end portion of the delivery apparatus and restrict axial and/or radial movement of the delivery apparatus 200 relative to the alignment guide. The retention elements may also be configured to engage a casing disposed around the distal end portion of the delivery apparatus 200. In some examples, the retention elements may be configured to engage the crimp alignment tool 400 which is disposed around the distal end portion of the delivery apparatus 200.

[0164] In some examples, the retention elements comprise a support portion configured to receive a distal end portion of the prosthetic delivery apparatus. The support portion is configured to retain the distal end portion of the prosthetic delivery apparatus in a radial direction. In some examples, the support portion allows rotational motion around a central axis. In some examples, the support portion comprises an aperture 610 in the distal wall 608, which is sized and shaped to receive a portion of the distal end portion of the prosthetic delivery apparatus, such as the stylet 250 of the delivery apparatus 200. In some examples, the aperture 610 is circular, but in other examples it may be another suitable shape. In some examples, the support portion may have a different configuration, such as a recess in the distal wall, a groove in the distal wall, and/or a hollow protrusion on the distal wall.

[0165] In some examples, the one or more retention elements comprises one or more retention arms 622. In the depicted example, there are two retention arms 622. The retention arms 622 may have a free end and an attached end. In some examples the attached end may be coupled to an internal structure that is positioned distal to the coupling portion 606 and proximal to the distal wall 608. In the depicted example, the attached ends of the retention arms are coupled to a midwall 624 which comprise a semicircular wall with an opening 626 which partially defines the central channel 602. The free end of the retention arms 622 may be configured to couple with features on the distal end portion of the delivery apparatus 200 or the crimp alignment tool 400. In the depicted example, the free end of the retention arms comprises a lip portion 628 which extends radially inward and is configured to engage the crimp alignment tool 400 such as to correspond with the engagement feature 430 which can comprise an annular groove 432 as described above.

[0166] FIGS. 5-6 depict a crimper assembly comprising the crimping device 100 with the implant alignment device 500, the alignment guide 600, the prosthetic valve 300, and the distal end portion of the delivery apparatus 200 (covered by the crimp alignment tool 400) all used together to position the prosthetic valve 300 around the target crimping location on the distal end portion of delivery apparatus 200. As depicted, when crimping device 100, the implant alignment device 500, and the alignment guide 600 are coupled together they provide axial alignment, such that the crimper assembly central axis 101, the central axis 501 of the implant alignment device 500, and the longitudinal axis 601 of the alignment guide 600 are all substantially aligned with one another to form a common axis and the target crimping location of the balloon 230 is positioned within the crimper aperture 130 of the crimping device 100. FIG. 5 depicts a top-down cross section of the crimping device 100 and FIG. 6 depicts a side cross section of crimping device 100. [0167] To prepare the crimper assembly for crimping the prosthetic valve 300. The prosthetic valve 300 is positioned on the implant alignment device 500 on the support portion 504. In some examples, the crimp alignment tool 400 is operatively coupled to the balloon catheter 220. The balloon catheter 220 of the delivery apparatus 200 is then inserted within a central channel 508 of the implant alignment device 500 and within a central passage of the prosthetic valve 300. The balloon catheter 220, the prosthetic valve 300, and a distal end portion of the implant alignment device 500 are then positioned within a crimper aperture 130 of a crimping device 100 and the implant alignment device 500 is coupled to a first side portion 102 of the crimping device 100, such that the prosthetic implant is axially aligned with the compression elements. In this example, the first side portion 102 of the crimping device 100 may be referred to as a proximal side portion 102 of the crimping device 100. In the depicted example, the prosthetic valve 300 is aligned with jaws 114 of the crimping device 100. The balloon catheter is advanced through the crimping device and positioned into the alignment guide 600 that is coupled to a second side portion of the crimping device, which in this example may be referred to as a distal side portion of the crimping device. The distal end portion of the implant alignment device 500 may be captured by the crimp alignment tool with one or more retention members.

[0168] As depicted in FIG. 5, the prosthetic valve 300 is installed on the support portion 504 of the implant alignment device 500 such that the free ends 550 of each alignment member 506 axially overlaps with the proximal end portion of the prosthetic valve 300. The distal end portion of the delivery apparatus 200 is inserted such that it extends through the implant alignment device 500 and the prosthetic valve 300. As depicted in FIG. 6, the implant alignment device 500 is coupled to the crimping device 100 with the coupling member 522 which is inserted into cut-out portion 108 on the first side portion 102 of the crimping device 100. The coupling member 522 sits on the ledge created by the cut-out portion 108 and is held in place by friction. This configuration allows the coupling member 522 to slide in an axially proximal direction and detach from the crimping device 100 as the implant 300 is crimped.

[0169] Returning to FIG. 5, the alignment guide 600 is coupled with the second side portion 104 of the crimping device by the one or more fingers 612 which are inserted into the one or more slots 106. The distal end portion of the delivery apparatus 200 (covered by the crimp alignment tool 400) is inserted into the central channel 602 and is retained by one or more retention elements. In the depicted example, the one or more retention elements comprise the aperture 610 in the distal wall 608, which captures the stylet 250. The one or more retention members also comprise two retention arms 622 which couple with the engagement feature 430.

[0170] As depicted in FIGS. 5-6, coupling the crimping device 100 with the implant alignment device 500, and the alignment guide 600, and installing the distal end portion of the delivery apparatus 200 within this assembly, ensures that the prosthetic valve 300 is positioned within the jaws 114 and disposed around the target crimping location on the balloon 230. The prosthetic valve 300 can then be accurately crimped.

[0171] As discussed above, crimping the prosthetic valve 300 may comprise one or more crimping motions, wherein each of the crimping motions has the result of ensuring the annular frame is properly crimped. In some examples, crimping the prosthetic valve 300 results in the implant alignment device 500 being ejected from the crimping device. The balloon catheter and the crimped prosthetic implant, which is now disposed on the balloon catheter, are then removed from the alignment guide 600, crimping device 100, and implant alignment device 500.

[0172] FIGS 7A-7C depict aspects of an alignment guide 700 according to another example. The alignment guide is configured to receive and position a distal end portion of the delivery apparatus 200, such as for example, the distal end of the balloon 230 which may be covered by the crimp alignment tool 400 (e.g., see FIG. 2). The alignment guide may comprise a central channel 702 defining a longitudinal axis 701, a coupling portion 706, a proximal wall 707, a distal wall 708, and one or more retention elements. The central channel may be defined by an outer wall 703, which is coupled to the proximal wall 707 at a proximal end portion and coupled to the distal wall 708 at a distal end portion. In some examples, the proximal wall 707, the outer wall 703 of the central channel 702, and the distal wall 708 are formed of one continuous piece of material. The central channel 702 is sized and shaped to receive the distal end portion of the delivery apparatus 200 which in some examples may be covered by the crimp alignment tool 400.

[0173] In some examples, the proximal wall 707 comprises an inner portion 707a and an outer portion 707b. The outer portion 707b is disposed radially outward from the inner portion 707a. In the depicted example, the inner portion 707a and the outer portion 707b are disposed in the same plane. [0174] The coupling portion 706 is disposed radially outward from the central channel 702 and in some examples is coupled to the outer portion 707b of the proximal wall 707. The coupling portion 706 is configured to releasably secure the alignment guide 700 to a crimping device such as to the second side portion 104 of the crimping device 100. In some examples, the coupling portion 706 comprises a plurality of arms 712 which extend radially outward from the outer portion 707b of the proximal wall 707 in a spiral arm pattern. The plurality of arms 712 are sized and shaped to fit with corresponding features on the second side portion 104 of the crimping device 100, such as one or more slots 106. In the depicted example, the coupling portion 706 comprises three arms 712. Each arm 712 comprises a free end 714 and attached end 716. In some examples, the free end 714 can includes a protrusion 720 (or nub or bump) that protrudes radially outward from a radial outer surface of the free end 714. In some examples, the coupling portion 706 is configured to be twisted around the longitudinal axis to couple with the second side portion 104 of the crimping device 100, such as by turning the alignment guide 700 a quarter turn. This configuration may have the advantage of ensuring a secure connection between the plurality of arms 712 and the one or more slots 106. In some examples, the coupling portion 706 can have different configurations, such as a recess, snap-in feature, or alternate alignment features that are configured to mate with a corresponding mating interface of the crimping device 100. As one example, the coupling portion 706 may comprise one or more recess and the second side portion of the crimping device may comprise a corresponding one or more arms.

[0175] In some examples, one or more retention elements extend from the coupling portion. The one or more retention elements may be configured to engage a distal end portion of the delivery apparatus and restrict axial and/or radial movement of the delivery apparatus relative to the alignment guide. In some examples, the retention elements may be configured to engage a casing disposed around the distal end portion of the delivery apparatus 200. In some examples, the retention elements may be configured to engage the crimp alignment tool 400 which is disposed around the distal end portion of the delivery apparatus 200.

[0176] In some examples, the retention elements comprise a support portion configured to receive a distal end portion of the delivery apparatus 200. The support portion is configured to retain the distal end portion of the delivery apparatus in a radial direction. In some examples, the support portion allows rotational motion around a central axis. In some examples, the support portion comprises an aperture 710 in the distal wall 708 which is sized and shaped to receive a portion of the distal end portion of the prosthetic delivery apparatus, such as the stylet 250 of the delivery apparatus 200. In some examples, the aperture 710 is circular, but in other examples it may be another suitable shape.

[0177] In some examples, the one or more retention elements comprise one or more retention arms. In the depicted example, there are two retention arms 722. The retention arms may have a free end and an attached end. In some examples the attached end may be coupled to the outer wall 703. The free end of the retention arms 722 may be configured to couple with features on the distal end portion of the delivery apparatus 200 or the crimp alignment tool 400. In the depicted example, the free end of the retention arms 722 comprise a lip portion 728 which extends radially inward and is configured to engage the crimp alignment tool 400 such as to correspond with the engagement feature 430 which can comprise an annular groove 432 as described above.

[0178] FIGS. 8A-8B depict aspects of an alignment guide 700’ which should be understood to be the same as the alignment guide 700 as described above, except for the differences detailed below. The proximal wall 707 of the alignment guide 700’ comprises an inner portion 707a’ and an outer portion 707b’. The outer portion 707b’ is disposed radially outward from the inner portion 707a’. In the depicted example, the inner portion 707a’ is disposed axially proximal to the outer portion 707b’. This may have the advantage of decreasing the potential that the prosthetic valve 300 slides in an axially distal direction to axially overlap the proximal end 414 crimp alignment tool 400 during the crimping process.

[0179] Mounting the prosthetic implant directly onto the inflatable balloon prior to entering the patient’s vasculature can improve the reliability and ease of implanting the prosthetic valve at the target implantation site. Accordingly, the apparatuses and methods disclosed above can be used to crimp a prosthetic implant such as the implantable prosthetic valve 300 on the inflatable balloon 230 with a tightly compressed profile and at a precise target crimping location relative to the delivery apparatus 200. Manually aligning and mounting the prosthetic implant directly onto the inflatable balloon can present challenges and may require extensive training for users. The apparatuses and methods described above increase automation in the valve crimping process, which in turn can increase accuracy and uniformity of the positioning of the crimped prosthetic implants while reducing the amount of training required for users to proficiently place the prosthetic implants. The proper placement of the crimped prosthetic implant at the target crimping location of the balloon can help to ensure a predictable deployment. An accurate and precise crimp at the target crimping location helps to ensure repeatable and reliable implant expansion and deployment shape of the frame. The crimping tools described herein can help to ensure repeatability and reliability.

[0180] FIG. 9 shows a prosthetic heart valve 800, which can be one specific example of the prosthetic valve 300 described above. As shown, the heart valve 800 comprises an annular frame, or stent, 802 which can support a leaflet structure 804 and/or an outer skirt 806. In some examples, the prosthetic heart valve 800 is adapted to be implanted in the native mitral valve and can be implanted in the body using, for example, the delivery apparatus 200 described above. The prosthetic valve 800 can also be implanted within the body using any of the other delivery apparatuses described herein.

[0181] In some examples, the frame 802 comprises a plastically expandable material, which can be 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 802 can comprise stainless steel. In some examples, the frame 802 can comprise cobalt-chromium. In some examples, the frame 802 can comprise nickel-cobalt-chromium. In some examples, the frame 802 comprises a nickel- cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R3OO35 (covered by ASTM F562-02). MP35N™/UNS R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0182] FIGS. 10 A- 10C depict aspects of an implant alignment device 1000 according to another example. Similar to the implant alignment device 500 of FIGS. 3 A-3C, the implant alignment device 1000 is configured to receive a prosthetic implant thereon and to couple to a crimping device. Except as discussed herein, the implant alignment device 1000 may share any suitable attributes, features, characteristics, etc. with the alignment device 500 and/or may be used in conjunction with a crimping device in a substantially similar manner as the alignment device 500.

[0183] As shown in the side view of FIG 10A and the perspective view of FIG. 10C, the implant alignment device 1000 includes a coupling portion 1002 and a support portion 1004 (also referred to as an “implant support portion”) with one or more support members 1006 (e.g., three in this example). The implant alignment device 1000 also includes a central channel 1008 extending through the coupling portion 1002 and the support portion 1004. The central channel 1008 defines a central axis 1001 and is sized and shaped to receive a delivery apparatus for the prosthetic implant therethrough (for example, delivery apparatus 200).

[0184] As described more fully below, the coupling portion 1002 can be configured to releasably couple to a crimping device, such as the crimping device 100 shown in FIGS. 1A and 5-6. The support portion 1004 can be configured to support a prosthetic implant (for example, the prosthetic valve 300, a stent, etc.) on an outward facing support surface 1007 of each support member 1006. In some examples, as shown in FIGS. 10A-10C, the support portion 1004 is disposed at and extends distally from the coupling portion 1002. The support surfaces 1007 of the support members 1006 can be configured to be inserted into the prosthetic implant. The support members 1006 can be used to support the prosthetic implant at a location that is spaced apart from the coupling portion 1002, e.g., to position the prosthetic implant at a desired axial position within the crimping device. In some instances, the support portion 1004 and coupling portion 1002 (and the support members 1006) can be formed (e.g., molded together) as one piece (as a unitary component). As discussed in more detail below, the support members 1006 may be configured to bend, flex, and/or otherwise deflect radially inward during crimping of the prosthetic implant to facilitate ejection of the implant alignment device 1000 from the crimping device.

[0185] As introduced above, the coupling portion 1002 can be configured to be inserted into the crimper aperture 130 of the crimping device 100 and couple to the crimping device 100. In contrast with the examples discussed above, the coupling portion 1002 can be configured to be inserted into the crimper aperture 130 from the second side portion 104 of the crimping device 100, which in this example may be referred to as a proximal side portion of the crimping device.

[0186] The coupling portion 1002 includes a first end 1012 (proximal end) and a second end 1014 (distal end). The coupling portion 1002 defines a lumen that forms a portion of the central channel 1008. A cylindrical wall 1016 extends between the first end 1012 and the second end 1014 of the coupling portion 1002. In some examples, the first end 1012 can be referred to as a first end of the cylindrical wall 1016 and the second end 1014 can be referred to as the second end of the cylindrical wall 1016.

[0187] The coupling portion 1002 includes a plurality of radial projections 1022 extending radially away from the cylindrical wall 1016 and configured to mate with corresponding slots and/or indentations of the crimping device 100. For example, each radial projection 1022 can be configured to be received a corresponding slot 106. In this manner, the radial projections 1022 can be configured to rotationally align the coupling portion 1002 with the crimping device 100 and/or to restrict and/or prevent rotation of the implant alignment device 1000 relative to the crimping device 100. In some examples, the radial projections 1022 may be capable of interfacing with the slots 106 of the crimping device 100 only in one of a finite plurality of rotational orientations, such as one of three rotational orientations. In other examples, the radial projection 1022 may be configured to engage the corresponding slots 106 in only one rotational orientation.

[0188] In some examples, the radial projections 1022 can have different configurations, such as alternative alignment features for mating with a corresponding mating interface of the crimping device 100. As one example, the crimping device can comprise one or more projections (in lieu of the slots 106) and the coupling member can comprise one or more slots (in lieu of the radial projections) configured to receive the projections of the crimping device.

[0189] As shown in FIGS. 10A-10C, the cylindrical wall 1016 of the coupling portion 1002 can include one or more retaining members 1032 which can be configured as axial locking mechanisms that prevent the coupling portion 1002 from moving axially relative to the crimping device after the implant alignment device 1000 is attached to the crimping device. As a result, the implant alignment device 1000 can be retained in a predetermined axial position within the crimping device and relative to a delivery apparatus that is inserted into and coupled with the crimping device.

[0190] In some examples, the coupling portion 1002 includes three retaining members 1032 spaced 120 degrees apart from one another around the coupling portion 1002.

[0191] In other examples, the coupling portion 1002 can include more or fewer than three retaining members 1032 (e.g., one, two, four, etc.).

[0192] Each retaining member 1032 can comprise a finger with a free end 1034 and an attached end 1036 and that are formed by a U-shaped slot 1033 in (through) the cylindrical wall 1016. The free end 1034 includes a protrusion 1038 (or nub or bump) that protrudes radially outward from an outer surface of the free end 1034.

[0193] The retaining member 1032 can be configured as a cantilever, where the free end 1034 deflects radially inward as the implant alignment device 1000 is slid into the central channel of the crimping device and then deflects radially outward with the protrusion 1038 engaging a portion of the crimping device. [0194] In some instances, the protrusion 1038 can be a spherical nub with a radius that is specified to allow easy insertion and locking into the predetermined axial position within the crimping device and also easy release from the crimping device (such that the implant alignment device 1000 can be removed) upon crimping with the crimping device.

[0195] As shown in FIGS. 10 A- 10C, the implant alignment device 1000 includes three support members 1006 circumferentially spaced 120 degrees apart from one another around the central axis 1001. In other examples, the implant alignment device 1000 can include more or fewer than three support members 1006 (for example, one, two, four, etc.). Each support member 1006 includes a support surface 1007 for engaging and/or supporting the prosthetic implant. Each support member 1006 also includes a support body 1046 that at least partially defines a support ledge 1048 that is configured to engage a portion of the prosthetic implant to define an axial position of the prosthetic implant relative to the implant alignment device 1000.

[0196] Each support member 1006 includes an attached end 1042 and a free end 1044 disposed axially away from the attached end 1042. In the examples of FIGS. 10A-10C, the attached end 1042 is attached to an annular projection 1040 of the support portion 1004, which in turn extends distally from the coupling portion 1002. In this manner, each attached end 1042 may be described as being spaced apart from the coupling portion 1002 by the annular projection 1040. Each support member 1006 may be described as extending axially distally from the annular projection 1040.

[0197] As shown in FIGS. 10A and 10C, each support member 1006 includes a flexure region 1050 proximate to the attached end 1042, the annular projection 1040, and/or the coupling portion 1002. The flexure region 1050 is configured such that the support member 1006 flexes, bends, and/or otherwise deflects within the flexure region 1050 relative to the annular projection 1040 and/or relative to the coupling portion 1002. In particular, each support member 1006 can be configured to bend within the flexure region 1050 to move the support surface 1007 and/or the free end 1044 radially toward the central axis 1001 in response to a radially inwardly directed force applied to the support surface 1007 (for example, during crimping with the crimping device 100).

[0198] As described in more detail below, each support member 1006 may be configured to transition between a supporting configuration (as illustrated in FIGS. 10A-10C) and an ejection configuration. When the support members 1006 are in the supporting configuration, the support members 1006 and/or the support surfaces 1007 thereof are positioned to support a prosthetic implant thereon. When the support members 1006 are in the ejection configuration, the support surfaces 1007 and/or the free ends 1044 are radially deflected toward the central axis 1001 to disengage from the prosthetic implant and/or to facilitate ejection of the implant alignment device 1000 from the crimping device. Each support member 1006 may be biased toward the supporting configuration. The supporting configuration also may be referred to as an uncollapsed configuration, and/or the ejection configuration also may be referred to as a collapsed configuration.

[0199] The flexure region 1050 of each support member 1006 may be configured to facilitate transitioning the support member 1006 between the supporting configuration and the ejection configuration in any of a variety of manners. For example, and as shown in FIGS. 10A and 10C, the flexure region 1050 can include an indentation 1052 to facilitate flexure of the support member 1006 in the flexure region 1050. The indentation 1052 can correspond to and/or yield a region of the support member 1006 with a reduced thickness relative to a remainder of the support member 1006. For example, the support member 1006 may be formed of a material that exhibits sufficient rigidity to support the prosthetic implant in relatively thick regions of the support member (e.g., in regions including the support surface 1007 and/or the support body 1046) and that exhibits elastic resilience when thinned by the indentation 1052. In this manner, the flexure region 1050 may be described as representing a living hinge mechanism to permit the free end 1044 to deflect relative to the attached end 1042 while the support member 1006 is formed as a monolithic and/or unitary component.

[0200] It also is within the scope of the present disclosure that the support member 1006 and/or the flexure region 1050 can have any other suitable configuration for transitioning the support member 1006 between the supporting configuration and the ejection configuration. For example, at least a portion of the flexure region 1050 may be formed of a different material than another portion (for example, a remainder) of the support member 1006. Additionally, or alternatively, the flexure region 1050 can include a mechanical hinge mechanism, such as a spring-biased hinge mechanism where the spring(s) biases the support member to the supporting configuration and the crimping device is configured to exert a force greater than the spring force to move the support member to the ejection configuration.

[0201] In some examples, the support members 1006 can be configured to abut and/or engage one another when in the ejection configuration. In particular, and as shown in FIGS. 10B-10C, the free end 1044 of each support member 1006 can include an alignment tab 1054 and/or an alignment receiver 1056. Each alignment receiver 1056 can be configured to receive the alignment tab 1054 of an adjacent support member 1006 when the support members 1006 are in the ejection configuration. In this manner, the engagement between the alignment tabs 1054 and the alignment receivers 1056 can facilitate ensuring radial alignment of the free ends 1044 of the support members 1006 as the support members 1006 approach and/or reach the ejection configuration.

[0202] FIGS. 11A-11C illustrate a manner in which the support members 1006 of the implant alignment device 1000 can operate in conjunction with the crimping device 100. FIG. 11 A illustrates a configuration in which the prosthetic valve 300 is mounted on the implant alignment device 1000 and in which the implant alignment device 1000 positions the prosthetic implant within the crimper aperture 130 of the crimping device 100. Similar to FIGS 10A-10C, FIG. 11A illustrates the support members 1006 in the supporting configuration, such that the support members 1006 are positioned to support the prosthetic valve 300 on the support surfaces 1007.

[0203] As shown in FIG. 11 A, the coupling portion 1002 of the implant alignment device 1000 can be coupled to the second side portion 104 of the coupling device 100, which in this example may be referred to as the proximal side portion. When the implantable valve 300 is supported by the support portion 1004 and the coupling portion 1002 is coupled to the coupling device 100, the implant alignment device 1000 positions the implantable valve 300 within the crimper aperture 130 at a desired axial location. In particular, the axial position of the implantable valve 300 within the crimper aperture 130 can be at least partially defined by the interface between the implant alignment device 1000 and the coupling device 100 and/or by engagement between the implantable valve 300 and the support ledges 1048 of the support members 1006 (shown in FIGS. 10A-10C).

[0204] As shown in FIG. 1 1 A, the supporting configuration of each support member 1006 may be at least partially characterized in terms of a support angle 1064. Specifically, the support angle 1064 can represent an angle of at least a portion of the support member 1006 (e.g., the support surface 1007) relative to a direction parallel to the central axis 1001 when the support member 1006 is in the supporting configuration. In various examples, it may be desirable to configure the implant alignment device 1000 such that the support angle 1064 is sufficiently small to securely support the implantable valve 300 on the support portion 1004. For example, the implantable valve 300 may include a leaflet structure that is biased toward a naturally open state such that the leaflet structure grips onto the support members 1006 less securely than would a naturally closed leaflet structure. As examples, the support angle 1064 may be at least 1 degree, at least 3 degrees, at least 5 degrees, at most 7 degrees, at most 4 degrees, and/or at most 2 degrees.

[0205] FIG. 1 1 A additionally illustrates an example of an interface between the retaining member 1032 and the crimping device 100. In the example of FIG. 11A, the second side portion 104 of the crimping device 100 includes an engagement arm 107 that defines a recess 109 on an interior side (for example, a distally facing side) thereof. The illustrated engagement arm 107 may be one of a plurality of engagement arms 107 of the crimping device 100, such as may define the slots 106 therebetween. As shown in FIG. HA, the recess 109 can receive the protrusion 1038 of the illustrated retaining member 1032. For example, as the implant alignment device 1000 is slid into the crimper aperture 130, the free end 1034 deflects radially inward as the engagement arm 107 urges the protrusion 1038 radially inward. When the implant alignment device 1000 reaches the axial position shown in FIG. 11 A, the resiliency of the retaining member 1032 can cause the protrusion 1038 to snap into position within the recess 109 and/or in engagement with an interior surface of the engagement arm 107. Such engagement can operate to restrict inadvertent removal of the implant alignment device 1000 from the crimping device 100 prior to crimping the prosthetic valve 300.

[0206] A length of the retaining member 1032 and size (for example, radius and/or height) of the protrusion 1038 can be specified such that the free end 1034 easily snaps into the recess 109 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).

[0207] FIG. 11B illustrates an intermediate configuration of the crimping device 100, in which the jaws 114 of the crimping device 100 have partially crimped the prosthetic valve 300. As shown in FIG. 1 IB, the radially inwardly directed force of the jaws 114 also operates to deflect the support members 1006 radially inward toward the central axis 1001, thereby transitioning the support members 1006 to the ejection configuration. With the support members 1006 in the ejection configuration, further radially inward movement of the jaws 114 can operate to eject the implant alignment device 1000 out of the crimper aperture 130 while the implantable valve 300 remains supported within the crimper aperture 130, such as by the jaws 114. [0208] In the configuration shown in FIG. 11B, the prosthetic valve 300 is supported by the jaws 114 and is disengaged from the support members 1006 of the implant alignment device 1000. In other examples, the prosthetic valve 300 may remain slightly engaged with the support members 1006 when the support members 1006 are in the ejection configuration.

[0209] As shown in FIG. 1 IB, the ejection configuration of each support member 1006 may be at least partially characterized in terms of an ejection angle 1066. Specifically, the ejection angle 1066 can represent an angle of at least a portion of the support member 1006 (for example, the support surface 1007) relative to a direction parallel to the central axis 1001 when the support member 1006 is in the ejection configuration.

[0210] In various examples, it may be desirable to configure the implant alignment device 1000 such that the ejection angle 1066 is sufficiently large to ensure ejection of the implant alignment device 1000 by the crimping device 100. For example, the radially inwardly directed force exerted by the jaws 114 on the support members 1006 (through direct contact and/or via the prosthetic valve 300) can yield a laterally directed (for example, proximally directed) force on the implant alignment device 1000. The laterally directed force can operate to eject the implant alignment device 1000 from the crimping device 100. Because the relative magnitude of the laterally directed force generally increases with the ejection angle 1066, increasing the ejection angle 1066 can ensure that the implant alignment device 1000 is ejected from the crimping device 100. As examples, the ejection angle 1066 may be at least 10 degrees, at least 13 degrees, at least 15 degrees, at least 20 degrees, at most 25 degrees, at most 17 degrees, at most 14 degrees, and/or at most 12 degrees.

[0211] In this manner, configuring the support members 1006 to bend, flex, deflect, and/or collapse relative to the central axis 1001 can facilitate achieving both a support angle 1064 that is sufficiently small to securely support the implantable valve 300 as well as an ejection angle 1066 that is sufficiently large to eject of the implant alignment device 1000 from the crimping device 100.

[0212] FIG. 11C illustrates a configuration in which the jaws 114 of the crimping device 100 have fully crimped the implantable valve 300 and in which the implant alignment device 1000 has consequently been ejected from engagement with the crimping device 100. In the example of FIG. 11C, the support members 1006 have returned to the supporting configuration, such as due to the elastic resilience of the support members 1006. With the implant alignment device 1000 ejected and in the supporting configuration, the delivery apparatus together with the prosthetic implant can be withdrawn through the central channel 1008 of the implant alignment device.

[0213] FIGS. 12A-12C depict aspects of an implant alignment device 1100 according to another example. Similar to the implant alignment device 500 of FIGS. 3 A-3C and the implant alignment device 1000 of FIGS. 10A-10C, the implant alignment device 1 100 is configured to receive a prosthetic implant thereon and to couple to a crimping device. Except as discussed herein, the implant alignment device 1100 may share any suitable attributes, features, characteristics, etc. with the alignment device 500 and/or with the implant alignment device 1000 and/or may be used in conjunction with a crimping device in a substantially similar manner as the implant alignment device 500 and/or the implant alignment device 1000.

[0214] As shown in the side view of FIG 12A and the perspective view of FIG. 12C, the implant alignment device 1100 includes a coupling portion 1102 and a support portion 1104 (also referred to as an “implant support portion”) with one or more support members 1106. The implant alignment device 1100 also includes a central channel 1108 extending through the coupling portion 1102 and the support portion 1104. The central channel 1108 defines a central axis 1101 and is sized and shaped to receive a delivery apparatus for the prosthetic implant therethrough (for example, delivery apparatus 200).

[0215] The coupling portion 1102 can be configured to releasably couple to a crimping device such as in the manner described above with respect to the crimping portion 1002 of the implant alignment device 1000. Each support member 1106 of the support portion 1004 includes an outward facing support surface 1107. The support members 1106 may be configured to bend, flex, and/or otherwise deflect radially inward during crimping of the prosthetic implant to facilitate ejection of the implant alignment device 1100 from the crimping device.

[0216] As shown in FIGS. 12A-12C, each support member 1106 includes an engagement feature 1162 that extends and/or protrudes radially away from the corresponding support surface 1107. The engagement features 1162 can be configured to enhance engagement between the support members 1106 and the implantable device, such as by increasing a friction force between the support members 1106 and the implantable device. In the depicted example, each support member 1106 takes the form of a circumferentially extending bar. In other examples, each engagement feature 1 162 can include and/or be any of a variety of shapes and/or forms, such as one or more protrusions, one or more axially extending features, one or more circumferentially extending features, and/or a textured surface feature of the support surface 1107.

[0217] Similar to the coupling portion 1002 of the implant alignment device 1000, the coupling portion 1 102 of the implant alignment device 1 100 can be configured to be inserted into the crimper aperture 130 of the crimping device 100 from the second side portion 104 of the crimping device 100. The coupling portion 1102 includes a first end 1112 (proximal end) and a second end 1114 (distal end). The coupling portion 1102 defines a lumen that forms a portion of the central channel 1108. A cylindrical wall 1116 extends between the first end 1112 and the second end 1114 of the coupling portion 1102. In some examples, the first end 1112 can be referred to as a first end of the cylindrical wall 1116 and the second end 1114 can be referred to as the second end of the cylindrical wall 1116.

[0218] As shown in FIGS. 12B-12C, the cylindrical wall 1116 includes and/or defines a cutout 1118 such that the cylindrical wall 1116 extends only partially circumferentially around the central axis 1101. The cutout 1118 can effectively connect the central channel 1108 to the region exterior of the implant alignment device 1100. Such a configuration can facilitate removal of the implant alignment device 1100 from the delivery apparatus. For example, subsequent to ejecting the implant alignment device 1100 from a crimping device during an implant crimping operation, a portion of the delivery apparatus (for example, the guide catheter shaft 214) can remain within the central channel 1108. The cutout 11 18 thus can allow for the implant alignment device 1100 to be removed from the delivery apparatus, such as by passing the guide catheter shaft through the cutout 1118.

[0219] The coupling portion 1102 includes a plurality of radial projections 1122 extending radially away from the cylindrical wall 1116, which are configured to mate with corresponding slots and/or indentations of the crimping device 100. For example, each radial projection 1122 can be configured to be received a corresponding slot 106 in the manner described above with respect to the radial projections 1022. As shown in FIGS. 12B-12C, one of the radial projections 1122 can include and/or define the cutout 1118 and thus include two spaced apart radial projection portions.

[0220] As shown in FIGS. 12A-12C, the cylindrical wall 1116 of the coupling portion 1102 can include one or more retaining members 1132 which can be configured as axial locking mechanisms that prevent the coupling portion 1 102 from moving axially relative to the crimping device after the implant alignment device 1100 is attached to the crimping device. As a result, the implant alignment device 1100 can be retained in a predetermined axial position within the crimping device and relative to a delivery apparatus that is inserted into and coupled with the crimping device.

[0221] Each retaining member 1 132 can comprise a finger with a free end 1 134 and an attached end 1136 that are formed by a U-shaped slot 1133 in (through) the cylindrical wall 1116. The free end 1134 includes a protrusion 1138 (or nub or bump) that protrudes radially outward from an outer surface of the free end 1034.

[0222] As shown in FIGS. 12A-12C, the implant alignment device 1100 includes three support members 1106 circumferentially spaced 120 degrees apart from one another around the central axis 1 101. In other examples, the implant alignment device 1 100 can include more or fewer than three support members 1106 (for example, one, two, four, etc.). Each support member 1106 includes a support surface 1107 for engaging and/or supporting the prosthetic implant. Each support member 1106 also includes a support body 1146 that at least partially defines a support ledge 1148 that is configured to engage a portion of the prosthetic implant to define an axial position of the prosthetic implant relative to the implant alignment device 1100.

[0223] Each support member 1106 includes an attached end 1142 and a free end 1144 disposed axially away from the attached end 1142. In the examples of FIGS. 12A-12C, the attached end 1142 is attached to and extends distally from the coupling portion 1102.

[0224] As shown in FIGS. 12A and 12C, each support member 1106 includes a flexure region 1150 proximate to the attached end 1142 and/or the coupling portion 1102. The flexure region 1 150 is configured such that the support member 1 106 flexes, bends, and/or otherwise deflects within the flexure region 1150 relative to the coupling portion 1102. In particular, each support member 1106 can be configured to bend within the flexure region 1150 to move the support surface 1107 and/or the free end 1144 radially toward the central axis 1101 in response to a radially inward directed force applied to the support surface 1107 (for example, during crimping with the crimping device 100).

[0225] Each support member 1 106 may be configured to transition between a supporting configuration (as illustrated in FIGS. 12A-12C) and an ejection configuration in a manner similar to that described with reference to the support members 1006 of the implant alignment device 1000. For example, and as shown in FIGS. 12A and 12C, each the flexure region 1150 can include an indentation 1152 to facilitate flexure of the support member 1106 in the flexure region 1150.

[0226] FIG. 13 illustrates an implant alignment device 1100’ supporting a prosthetic heart valve 1200. The implant alignment device 1100’ of FIG. 13 is substantially identical to the implant alignment device 1 100 of FIGS. 12A-12C with the exception that the implant alignment device 1100’ includes an annular projection 1140 similar to the annular projection 1040 of FIGS. 10A-10C. The prosthetic heart valve 1200 is supported by the support portion 1104. The prosthetic heart valve 1200 may represent an example of the implantable valve 300 and may share any suitable features with the prosthetic heart valve 800 discussed above. As shown in FIG. 13, the implant alignment device 1100 supports the prosthetic heart valve 1200 such that a proximal end region 1202 of the prosthetic heart valve 1200 engages the support ledges 1148 of each support member 1106.

[0227] In some examples, an alignment guide can comprise one or more indicators configured to correspond to a desired orientation of the prosthetic implant. As one example, the alignment guide can comprise a color (e.g., green) configured to correspond to a colored suture on the prosthetic valve, where the colored suture indicates an inflow end of the valve. As another example, the alignment guide can comprise an arrow (e.g., an arrow 1154), words, or other indicia configured to indicate the desired flow direction of the prosthetic heart valve. These features can help ensure that the prosthetic heart valve (or other prosthetic implant) is mounted on the delivery apparatus in the proper orientation for the particular implantation procedure.

[0228] FIGS. 14A-14D depict examples of an alignment guide 1300 according to another example. Similar to the alignment guide 700 discussed above, the alignment guide 1300 is configured to receive and position a distal end portion of a delivery apparatus while the delivery apparatus is inserted into a crimping device to axially align the delivery apparatus relative to the crimping device. The alignment guide 1 00 includes a central channel 1302 defining a longitudinal axis 1301, a coupling portion 1310, and a guide shaft 1340. The central channel 1302 extends through, and is at least partially defined by, the guide shaft 1340. The central channel 1302 is sized and shaped to receive the distal end portion of a delivery apparatus such as the delivery apparatus 200 discussed above. As shown in FIGS. 14B-14D, the alignment guide 1300 additionally includes a guide wall 1360 extending between the guide shaft 1340 and the coupling portion 1310. As discussed in more detail below, the guide shaft 1340 can include and/or define a viewing cutout 1350 and/or an alignment feature 1352 to facilitate axially aligning the delivery apparatus relative to the alignment guide 1300.

[0229] The coupling portion 1310 can include an outer wall 1304 that is disposed radially outward from the central channel 1302. The outer wall 1304 includes and extends between a proximal end region 1306 and a distal end region 1308. The coupling portion 1310 is configured to releasably secure the alignment guide 1300 to a crimping device, such as to the first side portion 102 of the crimping device 100.

[0230] In the example of FIGS. 14A-14D, the coupling portion 1310 includes an alignment member 1312 that is configured to engage the crimping device and/or to rotationally align the coupling portion 1310 with the crimping device. For example, the alignment member 1312 can be circumferentially positioned such that it aligns the coupling portion 1310 in a predetermined rotational orientation relative to the crimper aperture 130 of the crimping device 100. The alignment member 1312 can be shaped and/or otherwise configured to mate with the cut-out portion 108 of the coupling device 100. In this manner, the alignment member 1312 rotationally aligns the coupling portion 1310 with the crimping device, such as to ensure that the viewing cutout 1350 and/or the alignment feature 1352 are oriented to facilitate viewing of the delivery apparatus.

[0231] In some examples, as shown in FIGS. 14A-14D, the alignment member 1312 is an axially extending projection that extends proximally from the distal end region 1308 toward the proximal end region 1306 of the outer wall 1304. The alignment member 1312 can include an attached end 1316 that is coupled to the outer wall 1304 (and/or an associated supporting structure) and a free end 1314 axially displaced from the attached end 1316. The free end 1314 can taper to a point and/or to a narrower region. In various examples, the free end 1314 may taper at both a top (radially outward facing side) and bottom (radially inward facing side) to a point or tapered end or may taper from only the top side or the bottom side. The tapered free end 1314 can allow for easier insertion into and coupling with the cut-out portion 108 in the crimping device.

[0232] In some examples, the alignment member 1312 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 100. As one example, the crimping device can comprise a projection (in lieu of the cut-out portion 108) and the alignment member can comprise a slot (in lieu of the projection) configured to receive the projection of the crimping device.

[0233] The coupling portion 1310 also may have one or more components for restricting removal of the coupling portion 1310 from the crimping device 100. For example, the coupling portion 1310 can include one or more coupling fingers 1320, each of which includes a free end 1322 and an attached end 1324. Each coupling finger 1320 can be formed by a U- shaped slot 1328 in (through) the outer wall 1304. Each free end 1322 includes a protrusion 1326 (or nub or bump) that protrudes radially outward from an outer surface of the free end 1322.

[0234] Each coupling finger 1320 can be configured as a cantilever, where the free end 1322 deflects radially inward as the alignment guide 1300 is slid into the central channel of the crimping device and then deflects radially outward with the protrusion 1326 engaging a portion of the crimping device. In the illustrated example, the protrusion 1326 includes a pair of ramped surfaces to allow easy insertion and locking into the predetermined axial position within the crimping device and also easy release of the alignment guide 1300 from the crimping device.

[0235] As shown in FIGS. 14A-14C, the coupling portion 1 10 also may include one or more engagement protrusions 1330 extending radially from the outer wall 1304. The engagement protrusions 1330 can be configured to engage the first side portion 102 of the crimping device 100 when the alignment guide 1300 is coupled to the crimping device 100. For example, the engagement protrusions can restrict inadvertent removal of the alignment guide 1300 from the crimping device 100, can facilitate rotational alignment of the alignment guide 1300 relative to the crimping device, and/or may at least partially support the alignment guide 1300 in a coaxial configuration relative to the crimping device.

[0236] As shown in FIG. 14D, the central channel 1302 of the alignment guide can be at least partially defined by an inner wall 1342 of the guide shaft 1340. The alignment guide 1300 can be configured to facilitate guiding the distal end region of the delivery apparatus into the guide shaft while the alignment guide 1300 is coupled to the crimping device. For example, the guide wall 1360 can be angled, tapered, and/or ramped in the distal direction. Accordingly, if the distal end region of the delivery apparatus contacts the guide wall 1360 during insertion of the delivery apparatus into the crimping device, the guide wall 1360 can operate to guide the delivery apparatus radially inward toward the longitudinal axis 1301 and/or into the central channel 1302.

[0237] The guide shaft 1340 can facilitate axially aligning the distal end region of the delivery apparatus with the alignment guide 1300 in any of a variety of manners. For example, and as shown in FIG. 14D, a distal end region of the inner wall 1342 of the guide shaft 1340 can include and/or define an engagement surface 1346. The engagement surface 1346 can be configured to abut and/or engage a portion of the delivery apparatus, such as the stylet 250, to restrict further axial translation of the delivery apparatus in the distal direction. In some examples, the engagement surface 1346 can be angled, tapered, and/or ramped, such as in a manner corresponding to a shape of the stylet 250. Additionally, or alternatively, the guide shaft 1340 can include a distal aperture 1344 through which a distal end region of the delivery apparatus (e.g., a distal end of the stylet 250) extends when the delivery apparatus is axially aligned with the alignment guide 1300. In such examples, the engagement surfaced 1346 may he configured to direct the distal end region of the delivery apparatus toward and/or into the distal aperture 1344.

[0238] The guide shaft 1340 also may include one or more features to facilitate visual confirmation of the axial alignment of the delivery apparatus relative to the alignment guide 1300. For example, the guide shaft 1340 can include and/or define a viewing cutout 1350 that extends to the central channel 1302. The viewing cutout 1350 can be configured to permit visual inspection of one or more components of the distal end region of the delivery apparatus, such as the stylet 250 and/or a nosecone of the delivery apparatus. In the example of FIG. 1350, the viewing cutout 1350 extends fully to the distal end of the guide shaft 1340. Stated differently, in this example, the guide shaft 1340 does not extend fully around the longitudinal axis 1301 at the distal end thereof. Accordingly, the distal aperture 1344 may be described as being connected to the viewing cutout 1350.

[0239] The guide shaft 1340 additionally or alternatively can include and/or define an alignment feature 1352 configured to be axially aligned with a corresponding feature and/or component of the delivery apparatus. As shown in FIGS. 14A and 14D, the alignment feature 1352 can include and/or be a notch and/or groove defined in the guide shaft 1340. In other examples, the alignment feature 1352 additionally or alternatively can include visual indicators such as printed markings, raised features, etc. [0240] FIG. 15 illustrates a manner in which the coupling portion 1310 of an alignment guide 1300’ can be operatively coupled to the first side portion 102 of the crimping device 100 (shown here with various components of the crimping device 100 hidden for clarity). The alignment guide 1300’ of FIG. 15 is substantially identical to the alignment guide 1300 of FIGS. 14A-14D with the exception that, in the example of FIG. 15, the distal end region of the guide shaft 1340 extends fully around the longitudinal axis such that the viewing cutout 1350 does not extend fully to the distal end of the guide shaft 1340.

[0241] FIG. 15 illustrates a manner in which the alignment member 1312 can extend within the cut-out portion 108 of the crimping device 100. FIG. 15 additionally illustrates a manner in which each protrusion 1326 can engage corresponding interior surfaces of the crimping device 100 to restrict inadvertent removal of the alignment guide 1300 from the crimping device 100.

[0242] FIGS. 16A-16C depict an example in which the implant alignment device 1100 and the alignment guide 1300’ are operatively coupled to the crimping device 100 and the delivery apparatus 200 is axially aligned relative to the crimping device 100. Specifically, FIG. 16A is a top view of the depicted configuration, while FIG. 16B is a detail view of the distal end region of the delivery apparatus, and FIG. 16C is a cross-sectional view as viewed along the line 16C-16C of FIG. 16 A.

[0243] As shown in FIGS. 16A and 16C, the alignment guide 1300’ is operatively coupled to the first side portion 102 of the crimping device 100 and the implant alignment device 1100 is operatively coupled to the second side portion 104 of the crimping device 100. As shown in FIG. 16B, the implant alignment guide axially aligns the distal end region of the delivery apparatus 200 via engagement of the stylet 250 with the guide shaft 1340. This visual alignment may be confirmed, for example, through verification that the interface between the stylet 250 and the nosecone 270 of the delivery apparatus 200 is axially aligned with the alignment feature 1352, as viewed through the viewing cutout 1350.

[0244] As shown in FIG. 16C, the implant alignment device 1100 axially aligns the prosthetic heart valve 1200 relative to the jaws 114 of the crimping device 100. As additionally shown in FIG. 16C, the axial alignment of the delivery apparatus 200 relative to the crimping device 100 serves to axially align the inflatable balloon 230 relative to the jaws 114 of the crimping device 100. In this manner, the implant alignment device 1100 and the alignment guide 1 00 jointly operate to axially align the prosthetic heart valve 1200 relative to the inflatable balloon 230 such that the prosthetic heart valve 1200 may be crimped onto the inflatable balloon 230.

Delivery Techniques

[0245] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand).

Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0246] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0247] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve/pulmonary artery.

[0248] 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.

[0249] 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.

[0250] 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

[0251] 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.

[0252] Example 1. An assembly for crimping a prosthetic implant on a delivery apparatus, the assembly comprising: a crimping device comprising a central channel, a proximal side portion, and a distal side portion, wherein the central channel extends from the proximal side portion to the distal side portion; an alignment guide coupled to the distal side portion of the crimping device and configured to receive a distal end portion of a delivery apparatus; and an implant alignment device coupled to the proximal side portion of the crimping device and configured to position a prosthetic implant within the central channel of the crimping device.

[0253] Example 2. The assembly of any example herein, particularly example 1, wherein the alignment guide comprises a central channel configured to receive a distal end portion of a delivery apparatus.

[0254] Example 3. The assembly of any example herein, particularly any one of examples 1-2, wherein the alignment guide comprises one or more retention members configured to retain the distal end portion of the delivery apparatus.

[0255] Example 4. The assembly of any example herein, particularly any one of examples 1-3, wherein the implant alignment device has a coupling member positioned on an outer diameter of the implant alignment device which is sized and shaped to fit within a slot in the crimping device, wherein crimping the prosthetic implant results in the coupling member sliding out of and detaching from the crimping device.

[0256] Example 5. The assembly of any example herein, particularly any one of examples 1-4, wherein the prosthetic implant comprises a prosthetic valve.

[0257] Example 6. The assembly of any example herein, particularly any one of examples 1-4, wherein the prosthetic implant comprises a stent.

[0258] Example 7. An alignment guide for a delivery apparatus, the alignment guide comprising: an outer wall defining a central channel and a longitudinal axis, wherein the central channel is configured to receive a delivery apparatus for a prosthetic implant; a coupling portion coupled to a proximal end portion of the outer wall and disposed radially outward from the central channel and configured to releasably secure the alignment guide to a distal side portion of a crimping device; and one or more retention elements extending from the coupling portion and configured to engage a distal end portion of the delivery apparatus and restrict axial and/or radial movement of the delivery apparatus relative to the alignment guide.

[0259] Example 8. The alignment guide of any example herein, particularly example 7, wherein the one or more retention elements comprises a support portion configured to receive a distal end portion of the delivery apparatus, wherein the support portion is configured to retain the distal end portion of the delivery apparatus in a radial direction while allowing rotational motion around a central axis.

[0260] Example 9. The alignment guide of any example herein, particularly any one of examples 7-8, wherein the alignment guide further comprises a distal wall coupled to a distal end portion of the outer wall, and the one or more retention elements comprises an aperture in the distal wall.

[0261] Example 10. The alignment guide of any example herein, particularly any one of examples 7-9, wherein the one or more retention elements are configured to restrict axial movement.

[0262] Example 11. The alignment guide of any example herein, particularly any one of examples 7-10, wherein the one or more retention elements comprises one or more retention arms wherein each of the one or more retention arms is configured to capture the delivery apparatus and restricts axial movement.

[0263] Example 12. The alignment guide of any example herein, particularly example 11, wherein the one or more retention arms are further configured to restrict radial movement.

[0264] Example 13. The alignment guide of any example herein, particularly any one of examples 11-12, wherein the one or more retention arms comprises two retention arms.

[0265] Example 14. The alignment guide of any example herein, particularly any one of examples 11-13, wherein the delivery apparatus comprises an alignment cover and the one or more retention arms are configured to engage the alignment cover.

[0266] Example 15. The alignment guide of any example herein, particularly any one of examples 7-14 wherein the coupling portion comprises one or more coupling members configured to be inserted into a corresponding coupling portion of the crimping device.

[0267] Example 16. The alignment guide of any example herein, particularly any one of examples 7-15 wherein the coupling members are configured to be twisted around the longitudinal axis to couple with the crimping device. [0268] Example 17. The alignment guide of any example herein, particularly any one of examples 9-16, wherein the distal end portion of the delivery apparatus comprises a cylindrical stylet and wherein the stylet is sized and shaped to fit into the aperture in the distal wall.

[0269] Example 18. The alignment guide of any example herein, particularly any one of examples 7-17, wherein the delivery apparatus further comprises an alignment cover with an annular groove and the one or more retention elements are sized and shaped to couple with the annular groove.

[0270] Example 19. An assembly for crimping a prosthetic implant on a delivery apparatus, comprising: a crimping device; the alignment guide of any example herein, particularly any one of examples 7-18 coupled to the distal side portion of the crimping device; and an implant alignment device coupled to a proximal side portion of the crimping device.

[0271] Example 20. The assembly of any example herein, particularly example 19, wherein the implant alignment device comprises: a coupling portion configured to couple with a crimping device; a support portion coupled to the coupling portion, the support portion tapers from a wider end that is disposed adjacent to the coupling portion to a narrower end portion, wherein the support portion comprises an outward facing support surface that is configured to receive a prosthetic implant thereon; and a central channel defining a longitudinal axis and extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus therethrough.

[0272] Example 21. The assembly of any example herein, particularly example 20, wherein the coupling portion comprises a coupling member, wherein the coupling member is positioned radially outward from the support portion and sized and shaped to within a slot in the crimping device.

[0273] Example 22. The assembly of any example herein, particularly any one of examples 20-21, further comprising one or more one or more axially extending alignment members, each alignment member extending axially from the wider end of the support portion, wherein the one or more axially extending alignment members extend over the narrower end portion of the support portion, each alignment member comprising a free end configured to abut an end of the prosthetic implant.

[0274] Example 23. An implant alignment device configured to be releasably coupled to a crimping device, the implant alignment device comprising: a coupling portion configured to be releasably coupled to a proximal side portion of the crimping device; and a support portion with one or more support members, wherein each support member comprises an outward facing support surface, wherein the support surfaces are configured to be inserted into a prosthetic implant to support the prosthetic implant, and wherein the support members are configured to deflect radially inward during crimping of the prosthetic implant by the crimping device.

[0275] Example 24. The implant alignment device of any example herein, particularly example 23, wherein the coupling portion is configured to be inserted into a crimper aperture of the crimping device.

[0276] Example 25. The implant alignment device of any example herein, particularly any one of examples 23-24, further comprising a central channel extending through the coupling portion and the support portion, wherein the central channel is configured to receive a delivery apparatus for the prosthetic implant therethrough, and wherein the coupling portion defines a lumen that forms a portion of the central channel.

[0277] Example 26. The implant alignment device of any example herein, particularly any one of examples 23-25, wherein the coupling portion comprises a first end, a second end, and a cylindrical wall extending between the first end and the second end.

[0278] Example 27. The implant alignment device of any example herein, particularly example 26, wherein the coupling portion comprises a plurality of radial projections extending radially away from the cylindrical wall and configured to mate with corresponding features of the crimping device to restrict rotation of the implant alignment device relative to the crimping device.

[0279] Example 28. The implant alignment device of any example herein, particularly any one of examples 26-27, wherein the cylindrical wall comprises a cutout such that the cylindrical wall extends only partially around a central axis of the implant alignment device.

[0280] Example 29. The implant alignment device of any example herein, particularly example 28, wherein the cutout is configured to permit a portion of a delivery apparatus that extends through a central channel of the implant alignment device to pass through the cutout to permit the implant alignment device to be removed from the delivery apparatus.

[0281] Example 30. The implant alignment device of any example herein, particularly any one of examples 28-29, wherein the coupling portion comprises a plurality of radial projections extending radially away from the cylindrical wall, and wherein the cutout is formed in one of the plurality of radial projections.

[0282] Example 31. The implant alignment device of any example herein, particularly any one of examples 23-30, wherein each support member comprises a support body that at least partially defines a support ledge that is configured to engage a portion of the prosthetic implant to define an axial position of the prosthetic implant relative to the implant alignment device when the prosthetic implant is supported on the support surfaces.

[0283] Example 32. The implant alignment device of any example herein, particularly any one of examples 23-31, wherein each support member is configured to transition between a supporting configuration, in which the support surfaces of the support members are positioned to support the prosthetic implant thereon, and an ejection configuration, in which the support surfaces are radially deflected toward a central axis of the implant alignment device to facilitate ejection of the implant alignment device from the crimping device.

[0284] Example 33. The implant alignment device of any example herein, particularly example 32, wherein each support member is biased toward the supporting configuration.

[0285] Example 34. The implant alignment device of any example herein, particularly any one of examples 32-33, wherein the support members are configured to engage one another when in the ejection configuration.

[0286] Example 35. The implant alignment device of any example herein, particularly example 34, wherein each support member comprises one or both of an alignment tab and an alignment receiver, and wherein, when the support members are in the ejection configuration, each alignment tab is received within a corresponding alignment receiver.

[0287] Example 36. The implant alignment device of any example herein, particularly any one of examples 32-35, wherein, when each support member is in the supporting configuration, the support surface is angled relative to a direction parallel to the central axis by a support angle that is one or more of at least 1 degree, at least 3 degrees, at least 5 degrees, at most 7 degrees, at most 4 degrees, or at most 2 degrees.

[0288] Example 37. The implant alignment device of any example herein, particularly any one of examples 32-36, wherein, when each support member is in the ejection configuration, the support surface is angled relative to a direction parallel to the central axis by an ejection angle that is one or more of at least 10 degrees, at least 13 degrees, at least 15 degrees, at least 20 degrees, at most 25 degrees, at most 17 degrees, at most 14 degrees, or at most 12 degrees.

[0289] Example 38. The implant alignment device of any example herein, particularly any one of examples 23-37, wherein each support member comprises an attached end and a free end disposed axially away from the attached end, and wherein the free end is configured to deflect radially inward during crimping of the prosthetic implant by the crimping device.

[0290] Example 39. The implant alignment device of any example herein, particularly example 38, wherein the support portion comprises an annular projection that extends distally from the coupling portion, and wherein the attached end of each support member is attached to and extends distally from the annular projection.

[0291] Example 40. The implant alignment device of any example herein, particularly example 38, wherein the attached end of each support member is attached to and extends distally from the coupling portion.

[0292] Example 41. The implant alignment device of any example herein, particularly any one of examples 38-40, wherein each support member comprises a flexure region proximate to the attached end, and wherein the flexure region is configured such that the support member bends within the flexure region relative to the coupling portion to move the free end radially toward a central axis of the implant alignment device in response to a radially inward directed force applied to the support surface.

[0293] Example 42. The implant alignment device of any example herein, particularly example 41, wherein the flexure region comprises an indentation configured to facilitate flexure of the support member in the flexure region.

[0294] Example 43. The implant alignment device of any example herein, particularly any one of examples 23-42, wherein each support member comprises an engagement feature configured to enhance engagement between the support member and the implantable device.

[0295] Example 44. The implant alignment device of any example herein, particularly example 43, wherein each engagement feature protrudes radially away from the support surface of the corresponding support member.

[0296] Example 45. The implant alignment device of any example herein, particularly any one of examples 43-44, wherein each engagement feature comprises one or more of a circumferentially extending feature, an axially extending feature, a protrusion, a plurality of protrusions, or a texture surface feature.

[0297] Example 46. An alignment guide for a delivery apparatus, the alignment guide comprising: a guide shaft; a central channel extending through the guide shaft and defining a longitudinal axis; and a coupling portion, wherein the central channel is configured to receive a distal end portion of the delivery apparatus while the delivery apparatus is inserted into a crimping device to axially align the delivery apparatus relative to the crimping device.

[0298] Example 47. The alignment guide of any example herein, particularly example 46, further comprising a guide wall extending between the guide shaft and the coupling portion, wherein the guide wall is ramped to guide the delivery apparatus radially inward toward the central channel.

[0299] Example 48. The alignment guide of any example herein, particularly example 47, wherein the coupling portion comprises an outer wall that is disposed radially outward from the central channel, and wherein the guide wall extends to a proximal end region of the outer wall.

[0300] Example 49. The alignment guide of any example herein, particularly any one of examples 46-48, wherein the coupling portion comprises an alignment member configured to engage the crimping device and to rotationally align the coupling portion with the crimping device.

[0301] Example 50. The alignment guide of any example herein, particularly any one of examples 46-49, wherein the alignment member comprises an axially extending projection that extends proximally from a distal end region of an outer wall of the coupling portion toward a proximal end region of the outer wall.

[0302] Example 51. The alignment guide of any example herein, particularly any one of examples 46-50, wherein the guide shaft comprises an inner wall that at least partially defines the central channel, and wherein a distal end region of the inner wall comprises an engagement surface configured to engage a portion of the delivery apparatus to restrict further axial translation of the delivery apparatus in the distal direction.

[0303] Example 52. The alignment guide of any example herein, particularly any one of examples 46-51, wherein the guide shaft comprises a distal aperture through which a distal end region of the delivery apparatus extends when the delivery apparatus is axially aligned with the alignment guide. [0304] Example 53. The alignment guide of any example herein, particularly any one of examples 46-52, wherein the guide shaft comprises a viewing cutout that extends to the central channel to permit visual inspection of one or more components of the delivery apparatus within the central channel.

[0305] Example 54. The alignment guide of any example herein, particularly example 53, wherein the viewing cutout extends fully to a distal end of the guide shaft, and wherein the guide shaft extends only partially around the longitudinal axis at the distal end.

[0306] Example 55. The alignment guide of any example herein, particularly example 53, wherein the viewing cutout is spaced apart from a distal end of the guide shaft, and wherein the guide shaft extends fully around the longitudinal axis at the distal end.

[0307] Example 56. The alignment guide of any example herein, particularly any one of examples 46-55, wherein the guide shaft comprises an alignment feature configured to be axially aligned with a corresponding feature of the delivery apparatus when the delivery apparatus is axially aligned with the alignment guide.

[0308] Example 57. The alignment guide of any example herein, particularly example 56, wherein the alignment feature comprises a groove defined in the guide shaft.

[0309] Example 58. The alignment guide of any example herein, particularly any one of examples 56-57, wherein the alignment feature comprises one or more of a visual indicator, a printed marking, or a raised feature.

[0310] Example 59. An assembly for crimping a prosthetic implant on a delivery apparatus, the assembly comprising: a crimping device; the implant alignment device of any example herein, particularly any one of examples 23-45; and the alignment guide of any example herein, particularly any one of examples 46-58.

[0311] Example 60. A method of mounting a prosthetic implant to a delivery apparatus, the method comprising: positioning a prosthetic implant comprising an annular frame onto an implant alignment device; inserting a balloon catheter of the prosthetic implant delivery apparatus within a central channel of the implant alignment device and within a central passage of the prosthetic implant; positioning the balloon catheter, the prosthetic implant, and a distal end portion of the implant alignment device within a central channel of a crimping device and coupling the implant alignment device to a proximal side portion of the crimping device, such that the prosthetic implant is axially aligned with compression elements of the crimping device; and advancing the balloon catheter through the crimping device and positioning the balloon catheter in an alignment guide that is coupled to a distal side portion of the crimping device.

[0312] Example 61. The method of any example herein, particularly example 60, further comprising, prior to positioning the prosthetic implant onto the implant alignment device, operatively coupling a crimp alignment tool to a distal portion of the delivery apparatus.

[0313] Example 62. The method of any example herein, particularly any one of examples 60-61 wherein the prosthetic implant comprises one or more commissures and positioning the prosthetic implant onto the implant alignment device comprises aligning the one or more commissures with one or more markings one the implant alignment device.

[0314] Example 63. The method of any example herein, particularly any one of examples 60-62, further comprising after inserting the balloon catheter within the central channel of the alignment guide, capturing the crimp alignment tool with one or more retention members.

[0315] Example 64. The method of any example herein, particularly any one of examples 60-63, further comprising crimping an annular frame of the prosthetic implant, resulting in a crimped prosthetic implant.

[0316] Example 65. The method of any example herein, particularly example 64, wherein the step of crimping the annular frame of the prosthetic implant comprises one or more crimping motions, wherein each of the crimping motions has the result of ensuring the annular frame is properly crimped.

[0317] Example 66. The method of any example herein, particularly any one of examples 60-65, wherein crimping the annular frame results in the implant alignment device being ejected from the crimping device.

[0318] Example 67. The method of any example herein, particularly any one of example 60-66, wherein the compression elements are a plurality of circumferentially arrayed nesting jaws.

[0319] Example 68. The method of any example herein, particularly any one of examples 64-67, further comprising removing the balloon catheter and the crimped prosthetic implant, which is now disposed on the balloon catheter, from the alignment guide, crimping device, and implant alignment device.

[0320] Example 69. The method of any example herein, particularly example 68, further comprising inserting the delivery apparatus into a patient’s vasculature. [0321] Example 70. A method of mounting a prosthetic implant to a delivery apparatus, the method comprising: positioning the prosthetic implant onto an implant alignment device; coupling the implant alignment device to a proximal side portion of a crimping device to position the prosthetic implant within a crimper aperture of the crimping device; coupling an alignment guide to a distal side portion of the crimping device; inserting the delivery apparatus through a central channel of the implant alignment device and through the crimper aperture; inserting a portion of the delivery apparatus within the alignment guide; and actuating the crimping device to crimp the prosthetic implant onto the delivery apparatus.

[0322] Example 71. The method of any example herein, particularly example 70, wherein the actuating the crimping device causes the implant alignment device to be ejected from the proximal side portion of the crimping device while the prosthetic implant remains within the crimper aperture.

[0323] Example 72. The method of any example herein, particularly any one of examples 70-71, wherein the implant alignment device comprises a support portion with one or more support members, wherein each support member comprises an outward facing support surface that supports the prosthetic implant when the prosthetic implant is positioned on the implant alignment device, and wherein the actuating the crimping device causes the support members to deflect radially inward.

[0324] Example 73. The method of any example herein, particularly any one of examples 70-72, further comprising removing the implant alignment device from the delivery apparatus while the delivery apparatus is positioned within the crimper aperture.

[0325] Example 74. The method of any example herein, particularly example 73, wherein the implant alignment device comprises a cylindrical wall that defines a cutout such that the cylindrical wall extends only partially circumferentially around a central axis of the implant alignment device, and wherein the removing the implant alignment device from the delivery apparatus comprises passing a portion of the delivery apparatus through the cutout.

[0326] Example 75. The method of any example herein, particularly any one of examples 70-74, wherein the inserting the portion of the delivery apparatus within the alignment guide comprises positioning the delivery apparatus in a predetermined axial position relative to the alignment guide.

[0327] Example 76. The method of any example herein, particularly any one of examples 70-75, wherein the alignment guide comprises a guide shaft that at least partially defines a central channel, and wherein the inserting the portion of the delivery apparatus within the alignment guide comprises advancing the delivery apparatus through the central channel.

[0328] Example 77. The method of any example herein, particularly any one of examples 70-76, wherein the alignment guide comprises an alignment feature, and wherein the inserting the portion of the delivery apparatus within the alignment guide comprises positioning the delivery apparatus relative to the alignment guide such that a portion of the delivery apparatus is axially aligned with the alignment feature.

[0329] Example 78. The method of any example herein, particularly any one of examples 70-77, further comprising inserting the delivery apparatus into a patient’s vasculature.

[0330] Example 79. The apparatus of any example herein, wherein the apparatus is sterilized.

[0331] Example 80. The method of any example herein, further comprising sterilizing the apparatus of any example herein.

[0332] 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 crimping assembly can be combined with any one or more features of another crimping assembly. As another example, any one or more features of one alignment guide can be combined with any one or more features of another alignment guide.

[0333] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

Claims:

1. An implant alignment device configured to be releasably coupled to a crimping device, the implant alignment device comprising: a coupling portion configured to be releasably coupled to a proximal side portion of the crimping device; and a support portion with one or more support members, wherein each support member comprises an outward facing support surface, wherein the support surfaces are configured to be inserted into a prosthetic implant to support the prosthetic implant, and wherein the support members are configured to deflect radially inward during crimping of the prosthetic implant by the crimping device.

2. The implant alignment device of claim 1, further comprising a central channel extending through the coupling portion and the support portion, wherein the central channel is configured to receive a delivery apparatus for the prosthetic implant therethrough, and wherein the coupling portion defines a lumen that forms a portion of the central channel.

3. The implant alignment device of any one of claims 1-2, wherein the coupling portion comprises a first end, a second end, and a cylindrical wall extending between the first end and the second end, wherein the cylindrical wall comprises a cutout such that the cylindrical wall extends only partially around a central axis of the implant alignment device, and wherein the cutout is configured to permit a portion of a delivery apparatus that extends through a central channel of the implant alignment device to pass through the cutout to permit the implant alignment device to be removed from the delivery apparatus.

4. The implant alignment device of any one of claims 1-3, wherein each support member comprises a support body that at least partially defines a support ledge that is configured to engage a portion of the prosthetic implant to define an axial position of the prosthetic implant relative to the implant alignment device when the prosthetic implant is supported on the support surfaces.

5. The implant alignment device of any one of claims 1-4, wherein each support member is configured to transition between a supporting configuration, in which the support surfaces of the support members are positioned to support the prosthetic implant thereon, and an ejection configuration, in which the support surfaces are radially deflected toward a central axis of the implant alignment device to facilitate ejection of the implant alignment device from the crimping device.

6. The implant alignment device of claim 5, wherein the support members are configured to engage one another when in the ejection configuration.

7. The implant alignment device of any one of claims 1-6, wherein each support member comprises an attached end and a free end disposed axially away from the attached end, and wherein the free end is configured to deflect radially inward during crimping of the prosthetic implant by the crimping device.

8. The implant alignment device of claim 7, wherein each support member comprises a flexure region proximate to the attached end, and wherein the flexure region is configured such that the support member bends within the flexure region relative to the coupling portion to move the free end radially toward a central axis of the implant alignment device in response to a radially inward directed force applied to the support surface.

9. The implant alignment device of claim 8, wherein the flexure region comprises an indentation configured to facilitate flexure of the support member in the flexure region.

10. An alignment guide for a delivery apparatus, the alignment guide comprising: a guide shaft; a central channel extending through the guide shaft and defining a longitudinal axis; and a coupling portion, wherein the central channel is configured to receive a distal end portion of the delivery apparatus while the delivery apparatus is inserted into a crimping device to axially align the delivery apparatus relative to the crimping device.

11. The alignment guide of claim 10, further comprising a guide wall extending between the guide shaft and the coupling portion, wherein the guide wall is ramped to guide the delivery apparatus radially inward toward the central channel.

12. The alignment guide of any one of claims 10-11, wherein the coupling portion comprises an alignment member configured to engage the crimping device and to rotationally align the coupling portion with the crimping device.

13. The alignment guide of any one of claims 10-12, wherein the guide shaft comprises an inner wall that at least partially defines the central channel, and wherein a distal end region of the inner wall comprises an engagement surface configured to engage a portion of the delivery apparatus to restrict further axial translation of the delivery apparatus in the distal direction.

14. The alignment guide of any one of claims 10-13, wherein the guide shaft comprises a distal aperture through which a distal end region of the delivery apparatus extends when the delivery apparatus is axially aligned with the alignment guide.

15. The alignment guide of any one of claims 10-14, wherein the guide shaft comprises a viewing cutout that extends to the central channel to permit visual inspection of one or more components of the delivery apparatus within the central channel.

16. The alignment guide of any one of claims 10-15, wherein the guide shaft comprises an alignment feature configured to be axially aligned with a corresponding feature of the delivery apparatus when the delivery apparatus is axially aligned with the alignment guide.

17. An assembly for crimping a prosthetic implant on a delivery apparatus, the assembly comprising: a crimping device; the implant alignment device of any one of claims 1-9; and the alignment guide of any one of claims 10-16.

18. A method of mounting a prosthetic implant to a delivery apparatus, the method comprising: positioning the prosthetic implant onto an implant alignment device; coupling the implant alignment device to a proximal side portion of a crimping device to position the prosthetic implant within a crimper aperture of the crimping device; coupling an alignment guide to a distal side portion of the crimping device; inserting the delivery apparatus through a central channel of the implant alignment device and through the crimper aperture; inserting a portion of the delivery apparatus within the alignment guide; and actuating the crimping device to crimp the prosthetic implant onto the delivery apparatus.

19. The method of claim 18, wherein the actuating the crimping device causes the implant alignment device to be ejected from the proximal side portion of the crimping device while the prosthetic implant remains within the crimper aperture.

20. The method of any one of claims 18-19, wherein the implant alignment device comprises a support portion with one or more support members, wherein each support member comprises an outward facing support surface that supports the prosthetic implant when the prosthetic implant is positioned on the implant alignment device, and wherein the actuating the crimping device causes the support members to deflect radially inward.

21. The method of any one of claims 18-20, further comprising removing the implant alignment device from the delivery apparatus while the delivery apparatus is positioned within the crimper aperture.

22. The method of any one of claims 18-21, wherein the inserting the portion of the delivery apparatus within the alignment guide comprises positioning the delivery apparatus in a predetermined axial position relative to the alignment guide.

23. The method of any one of claims 18-23, wherein the alignment guide comprises an alignment feature, and wherein the inserting the portion of the delivery apparatus within the alignment guide comprises positioning the delivery apparatus relative to the alignment guide such that a portion of the delivery apparatus is axially aligned with the alignment feature.

24. An alignment guide for a delivery apparatus, the alignment guide comprising: an outer wall defining a central channel and a longitudinal axis, wherein the central channel is configured to receive a delivery apparatus for a prosthetic implant; a coupling portion coupled to a proximal end portion of the outer wall and disposed radially outward from the central channel and configured to releasably secure the alignment guide to a distal side portion of a crimping device; and one or more retention elements extending from the coupling portion and configured to engage a distal end portion of the delivery apparatus and restrict axial and/or radial movement of the delivery apparatus relative to the alignment guide.

25. The alignment guide of claim 24, wherein the one or more retention elements comprises a support portion configured to receive a distal end portion of the delivery apparatus, wherein the support portion is configured to retain the distal end portion of the delivery apparatus in a radial direction while allowing rotational motion around a central axis.

26. The alignment guide of any one of claims 24-25, wherein the alignment guide further comprises a distal wall coupled to a distal end portion of the outer wall, and the one or more retention elements comprises an aperture in the distal wall.

27. The alignment guide of any one of claims 24-26, wherein the one or more retention elements are configured to restrict axial movement.

28. The alignment guide of any one of claims 24-27, wherein the one or more retention elements comprises one or more retention arms wherein each of the one or more retention arms is configured to capture the delivery apparatus and restricts axial movement.

29. The alignment guide of claim 28, wherein the delivery apparatus comprises an alignment cover and the one or more retention arms are configured to engage the alignment cover.

30. An assembly for crimping a prosthetic implant on a delivery apparatus, comprising: a crimping device; the alignment guide of any one of claims 24-29 coupled to the distal side portion of the crimping device; and an implant alignment device coupled to a proximal side portion of the crimping device.

31. The assembly of claim 30, wherein the implant alignment device comprises: a coupling portion configured to couple with a crimping device; a support portion coupled to the coupling portion, the support portion tapers from a wider end that is disposed adjacent to the coupling portion to a narrower end portion, wherein the support portion comprises an outward facing support surface that is configured to receive a prosthetic implant thereon; and a central channel defining a longitudinal axis and extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus therethrough.

32. A method of mounting a prosthetic implant to a delivery apparatus, the method comprising: positioning a prosthetic implant comprising an annular frame onto an implant alignment device; inserting a balloon catheter of the prosthetic implant delivery apparatus within a central channel of the implant alignment device and within a central passage of the prosthetic implant; positioning the balloon catheter, the prosthetic implant, and a distal end portion of the implant alignment device within a central channel of a crimping device and coupling the implant alignment device to a proximal side portion of the crimping device, such that the prosthetic implant is axially aligned with compression elements of the crimping device; and advancing the balloon catheter through the crimping device and positioning the balloon catheter in an alignment guide that is coupled to a distal side portion of the crimping device.

33. The method of claim 32, wherein the prosthetic implant comprises one or more commissures and positioning the prosthetic implant onto the implant alignment device comprises aligning the one or more commissures with one or more markings one the implant alignment device.

34. The method of any one of claims 32-33, wherein crimping the annular frame results in the implant alignment device being ejected from the crimping device.