Alignment tools for prosthetic implants

Abstract

Alignment tools and methods for locating prosthetic implants on delivery apparatuses are disclosed. The alignment tools can comprise a stop surface and an alignment surface disposed a distance from the stop surface. The stop surface engages a datum on a delivery apparatus and the alignment surface is configured to abut a portion of the prosthetic implant and align the prosthetic implant relative to the delivery apparatus. The alignment tool can further comprise a cavity configured to receive a portion of the delivery apparatus.

Description

Attorney Docket No: THVMC-23753WO01 ALIGNMENT TOOLS FOR PROSTHETIC IMPLANTS CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 634,255, filed April 15, 2024, which is incorporated by reference herein in its entirety. FIELD

[0002] The present disclosure relates to prosthetic implant preparation assemblies and associated methods, and more particularly to assemblies and methods that utilize an alignment device for positioning an implantable prosthetic implant onto a delivery apparatus. BACKGROUND

[0003] Prosthetic implants can be used to treat vascular disorders. For example, prosthetic heart valves can be used to treat issues with native heart valves. The native heart valves (the aortic, pulmonary, tricuspid, and mitral valves) serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. These heart valves can be rendered less effective by congenital, inflammatory, infectious, and other conditions. Such conditions can eventually lead to serious cardiovascular compromise or death.

[0004] A transcatheter technique can be used for introducing and implanting a prosthetic implant (e.g., a stent or a prosthetic heart valve) using a flexible catheter in a manner that is less invasive than open heart surgery. In this technique, a prosthetic implant can be mounted in a crimped state on the end portion of a flexible catheter and advanced through a blood vessel of the patient until the valve reaches the implantation site. The implant at the distal end of the catheter can then be expanded to its functional size at the site of the defective native vasculature or native valve, such as by inflating a balloon on which the implant is mounted. Alternatively, the implantAttorney Docket No: THVMC-23753WO01 can have a resilient, self-expanding frame that expands the valve to its functional size when it is advanced from a delivery sheath at the distal end of the catheter. Optionally, the implant can have a mechanically expandable frame, or the implant can have a combination of expansion mechanism, such as balloon-expandable, self-expandable, and / or mechanically expandable portions.

[0005] In some examples, prior to being inserted into a patient’s body, a prosthetic implant is typically placed over an expandable balloon of a delivery apparatus, and the prosthetic implant is crimped from an initial large diameter to a smaller diameter. The crimped prosthetic implant is then advanced into and through a patient’s vasculature a treatment site. The prosthetic implant is expanded at or adjacent the treatment site by inflating the balloon of the delivery apparatus. SUMMARY

[0006] Described herein are prosthetic implant preparation assemblies including crimper assemblies, implant delivery assemblies, and implantable prosthetic implants, such as prosthetic valves, as well as associated methods. Also described herein are alignment tools for positioning and aligning prosthetic implants on expandable balloons of delivery assemblies. The disclosed prosthetic implant preparation assemblies and methods can, for example, ensure that the prosthetic implant is crimped to an implant delivery apparatus at a desired location without the need for positional adjustment at an implantation site. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic implants, for example prosthetic heart valves, and their delivery apparatuses.

[0007] An alignment tool for locating a prosthetic implant on a delivery apparatus can comprise a stop surface and an alignment surface disposed a distance from the stop surface. In addition to these features, an alignment tool can further comprise one or more of the components and / or features disclosed herein.

[0008] In some examples, the stop surface can engage the delivery apparatus.Attorney Docket No: THVMC-23753WO01

[0009] In some examples, the alignment surface can be configured to abut a portion of the prosthetic implant and align the prosthetic implant relative to the delivery apparatus.

[0010] In some examples, the alignment tool can further comprise a cavity configured to receive a portion of the delivery apparatus.

[0011] In some examples, the stop surface can at least partially define the cavity.

[0012] In some examples, the alignment tool can further comprise an indicator specifying a location of the stop surface.

[0013] In some examples, the alignment tool can further comprise features for rotationally aligning the prosthetic implant.

[0014] In some examples, the alignment tool can rest on a top surface of a substrate.

[0015] In some examples, the alignment tool can be positioned at an angle relative to the top surface of the substrate.

[0016] In some examples, the prosthetic implant can be a prosthetic heart valve or a stent.

[0017] In some examples, the alignment tool can comprise a main body with a top surface, a first end, and a second end spaced apart from the first end by the top surface, where the cavity can be formed in the top surface.

[0018] In some examples, the main body can comprise the stop surface.

[0019] In some examples, the first end of the main body can form the alignment surface.

[0020] In some examples, the stop surface can contact a distal surface of a flexible catheter of the delivery apparatus.

[0021] In some examples, the stop surface can contact a tip of a nose cone of the delivery apparatus.

[0022] In some examples, the alignment surface can be perpendicular to the top surface of the main body.

[0023] In some examples, the alignment tool can comprise a wall extending from the top surface of the main body.Attorney Docket No: THVMC-23753WO01

[0024] In some examples, the wall can be disposed between the first end of the main body and the second end of the main body along at least a portion of the top surface.

[0025] In some examples, the wall can form at least a portion of the cavity.

[0026] In some examples, the wall can form a slot or a window.

[0027] In some examples, the wall can be curved.

[0028] In some examples, the stop surface can surround an aperture.

[0029] In some examples, the stop surface can be perpendicular to the top surface of the main body.

[0030] In some examples, the cavity can have a conical shape.

[0031] In some examples, an alignment tool for locating a prosthetic implant on a delivery apparatus comprises a stop surface, wherein the stop surface engages the delivery apparatus, and an alignment surface disposed a distance from the stop surface, wherein the alignment surface is configured to abut a portion of the prosthetic implant and align the prosthetic implant relative to the delivery apparatus.

[0032] In some examples, an alignment tool for a prosthetic implant comprises a main body with a top surface, a first end, a second end spaced apart from the first end by the top surface, and a cavity formed in the top surface, wherein the main body comprises a stop surface at least partially defining the cavity and configured for contacting a delivery apparatus, and wherein the first end of the main body forms an alignment surface configured for contacting the prosthetic implant.

[0033] In some examples, an alignment tool for a prosthetic implant comprises one or more of the features and / or components recited in Examples 1-20 and 45 below.

[0034] An assembly can comprise a crimp stop and an alignment tool, wherein the alignment tool is coupled to the crimp stop. In addition to these components, an assembly can further comprise one or more of the components and / or features disclosed herein.

[0035] In some examples, the assembly can be configured to attach to a crimper assembly.Attorney Docket No: THVMC-23753WO01

[0036] In some examples, a portion of the alignment tool can rest on a top surface of the crimper assembly.

[0037] In some examples, the alignment tool and the crimp stop can be formed as a single, integral piece.

[0038] In some examples, the alignment tool and the crimp stop can be formed as separate, attached pieces.

[0039] In some examples, an assembly comprises a crimp stop and an alignment tool, wherein the alignment tool is coupled to the crimp stop.

[0040] In some examples, an assembly comprises a crimp stop and an alignment tool comprising any one of the components and / or features recited in Examples 21-26 below.

[0041] A method of aligning a prosthetic implant on a delivery apparatus can comprise inserting a portion of a delivery apparatus into a cavity of an alignment tool. In addition to this step, the method of aligning a prosthetic implant on a delivery apparatus can further comprise one or more of the steps disclosed herein.

[0042] In some examples, the method can comprise positioning a datum of the delivery apparatus within the cavity and into contact with an inner surface at least partially defining the cavity.

[0043] In some examples, the method can comprise advancing the prosthetic implant over the delivery apparatus and into contact with an alignment surface of the alignment tool.

[0044] In some examples, the datum can be a nose cone.

[0045] In some examples, the datum can be a distal surface of a flexible catheter.

[0046] In some examples, the method can comprise visualizing the datum through a slot or a window in the alignment tool.

[0047] In some examples, the method can comprise crimping the prosthetic implant on the delivery apparatus before inserting the portion of the delivery apparatus into the cavity of the alignment tool.Attorney Docket No: THVMC-23753WO01

[0048] In some examples, the method can comprise crimping the prosthetic implant on the delivery apparatus after removing the delivery apparatus from the alignment tool.

[0049] In some examples, the method can comprise aligning a portion of the prosthetic implant rotationally relative to the alignment tool.

[0050] In some examples, a method of aligning a prosthetic implant on a delivery apparatus comprises inserting a portion of a delivery apparatus into a cavity of an alignment tool, positioning a datum of the delivery apparatus within the cavity and into contact with an inner surface at least partially defining the cavity, and advancing the prosthetic implant over the delivery apparatus and into contact with an alignment surface of the alignment tool.

[0051] In some examples, a method of aligning a prosthetic implant on a delivery apparatus comprises one or more of the steps recited in Examples 27-35 and 44 below.

[0052] A kit for a prosthetic implant preparation assembly can comprise a crimp stop and an alignment tool. In addition to these components, the kit can comprise one or more of the components disclosed herein.

[0053] In some examples, the alignment tool and the crimp stop can be configured for a specific prosthetic implant size and corresponding implant delivery apparatus.

[0054] In some examples, the kit can comprise coupling elements for securing the alignment tool to the crimp stop.

[0055] In some examples, the kit can comprise coupling elements for securing the alignment tool, the crimp stop, or both the alignment tool and the crimp stop to a substrate.

[0056] In some examples, the kit can comprise ramps, protrusions, or other angling elements.

[0057] In some examples, the kit can comprise the corresponding prosthetic implant.

[0058] In some examples, a kit for a prosthetic implant preparation assembly comprises a crimp stop and an alignment tool, wherein the alignment tool and the crimp stop are configured for a specific prosthetic implant size and corresponding implant delivery apparatus.

[0059] In some examples, a kit for a prosthetic implant preparation assembly comprises one or more of the elements recited in Examples 36-43 below.Attorney Docket No: THVMC-23753WO01

[0060] 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

[0061] FIG. 1A is a perspective view of a crimper assembly, according to an example.

[0062] FIG. 1B is a perspective view of a delivery apparatus for a prosthetic valve, according to an example.

[0063] FIG. 2 is a perspective view of an alignment tool, according to an example.

[0064] FIG. 3 a top view of the alignment tool of FIG. 2.

[0065] FIG. 4 is a cross-sectional view of the alignment tool of FIG. 2.

[0066] FIG. 5A is a side view of an implantable prosthetic valve positioned on a valve delivery apparatus with the implantable prosthetic valve in an uncrimped configuration.

[0067] FIG. 5B is a side view of the implantable prosthetic valve and the valve delivery apparatus of FIG. 5A with the implantable prosthetic valve in a partially crimped configuration.

[0068] FIG. 5C is a top view of the implantable prosthetic valve and the valve delivery apparatus of FIG. 5B in the alignment tool of FIG. 2 with the implantable prosthetic valve in an aligned position.

[0069] FIG. 5D is a side view of the aligned implantable prosthetic valve and the valve delivery apparatus of FIGS. 5C with the implantable prosthetic valve in a fully crimped configuration.

[0070] FIG. 6 is a perspective view of an alignment tool coupled to a crimp stop, according to an example.

[0071] FIG. 7 is a perspective view of the alignment tool and the crimp stop of FIG. 6.Attorney Docket No: THVMC-23753WO01

[0072] FIG. 8 is a side view of the alignment tool and the crimp stop of FIG. 6, showing an alignment tool angle.

[0073] FIG. 9 is a front view of the alignment tool and the crimp stop of FIG. 6, showing an alignment tool angle.

[0074] FIG. 10 is a perspective view of an alignment tool, according to an example.

[0075] FIG. 11 is a perspective view of the alignment tool of FIG. 10.

[0076] FIG. 12 is a top view of the alignment tool of FIGS. 10 and 11.

[0077] FIG. 13A is a side view of the implantable prosthetic valve and the valve delivery apparatus of FIG. 5A with the implantable prosthetic valve in a partially crimped configuration.

[0078] FIG. 13B is a top view of the implantable prosthetic valve and the valve delivery apparatus of FIG. 13A in the alignment tool of FIG. 10 with the implantable prosthetic valve in an aligned position.

[0079] FIG. 14 is a perspective view of an alignment tool coupled to a crimp stop, according to an example.

[0080] FIG. 15 is a perspective view of the alignment tool and the crimp stop of FIG. 14.

[0081] FIG. 16 is a side view of the alignment tool and the crimp stop of FIGS. 14 and 15, showing an alignment tool angle.

[0082] FIG. 17 is a top view of the alignment tool and the crimp stop of FIGS. 14 and 15, showing an alignment tool angle.

[0083] FIG. 18 is a flowchart depicting an example of a method of mounting, aligning, and crimping an implantable prosthetic valve to a valve delivery apparatus. DETAILED DESCRIPTION General Considerations

[0084] 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 directedAttorney Docket No: THVMC-23753WO01 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.

[0085] 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.

[0086] 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.

[0087] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (e.g., out of the patient’s body),Attorney Docket No: THVMC-23753WO01 while distal motion of the device is motion of the device away from the user and toward the implantation site (e.g., into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0088] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0089] Prosthetic implants (e.g., prosthetic valves, stents, etc.) disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic implants can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on the delivery apparatus. The prosthetic implant can be expanded to the radially expanded state once the prosthetic implant reaches the implantation site. It is understood that the prosthetic implant disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail below.

[0090] A prosthetic implant can be crimped onto an inflation balloon. Aligning the prosthetic implant relative to the delivery apparatus accurately and consistently can improve the predictability of the deployment process at the implantation location.

[0091] Therefore, a need exists for a tool to reliably position the prosthetic implant on an expandable balloon of a balloon delivery system in a desired location before inserting the prosthetic implant into the body. In this way, the implant is already in its desired position, or closer thereto, for deployment when inserted into the patient. Both mounting and positioning of a prosthetic implant onto an inflatable balloon as a part of a prep procedure prior to entering the patient’s vasculature can improve the reliability and ease of implanting the prosthetic device at the desired implantation site. Aligning a prosthetic implant as a part of a prep procedure is additionally or alternatively advantageous, for instance, when the implant (via an implant catheter) is inserted through an outer catheter (e.g., a guide sheath) due to limited space between the implant and the guide sheath.Attorney Docket No: THVMC-23753WO01

[0092] The present disclosure is generally directed to examples of prosthetic implant preparation assemblies and methods of utilizing various components of prosthetic implant preparation assemblies to prepare and align a prosthetic implant, for example a prosthetic heart valve or a stent, for delivery at an implantation site. Described herein are alignment tools for positioning a prosthetic implant on a balloon of a delivery apparatus, where the alignment tools locate the prosthetic implant in a desired location on a balloon in advance of insertion and delivery within a body.

[0093] Although the examples described herein are primarily directed to prosthetic heart valves deployed in a native valve, the examples and methods described herein can apply to prosthetic implants deployed in previously implanted valves, rings, grafts, or stents (for example, valve-in- valve or valve-in-ring applications). The disclosed devices and methods can be utilized at any location in a patient’s vasculature, including any of the native heart valves (e.g., mitral, aortic, pulmonary, and / or tricuspid). Additionally, although the examples described herein are primarily directed to prosthetic heart valves, the disclosed devices and methods can be used with various other prosthetic implants, including for instance, stents.

[0094] As shown in FIGS. 1A-1B, and discussed in more detail below, a prosthetic valve preparation assembly can comprise an implantable prosthetic valve 300, a valve delivery apparatus 200 configured to deliver the implantable prosthetic valve 300 to an implantation site, and a crimper assembly (also referred to herein as a “crimping device”) 100 for crimping the implantable prosthetic valve around the valve delivery apparatus.

[0095] In some examples, as shown in FIGS. 2-4, 6-12, and 14-17, alignment tools (also referred to herein as “alignment fixtures” or “fixtures”) can be used to align partially crimped prosthetic valves on an expandable balloon of a balloon delivery system before inserting the prosthetic valve into the body.

[0096] FIGS. 5A-5D and 13A-13B show steps described in an example method of FIG. 18, the steps including partially crimping, aligning, and fully crimping a prosthetic heart valve (for example, prosthetic valve 300, or any other prosthetic valve described herein) on an expandableAttorney Docket No: THVMC-23753WO01 balloon of a valve delivery apparatus (for example, the valve delivery apparatus 200, or any other valve delivery apparatus described herein) using a crimper assembly (for example, crimper assembly 100, or any other crimper assembly described herein) and an alignment tool. Examples of the Disclosed Technology

[0097] Various prosthetic valves 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 valves 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 disclosure of each of which is incorporated by reference herein.

[0098] Valve delivery assemblies and valve preparation assemblies, according to examples, and / or components thereof, are shown in FIGS. 1A, 1B, 5A-5D, and 13A-13B. While specific examples of valve delivery assemblies are discussed herein, general structures and methods of use of various valve delivery assemblies that can be adapted for use with the apparatuses and methods disclosed herein 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.

[0099] FIGS. 1B, 5A-5D, and 13A-13B illustrate an example of an implantable prosthetic valve (also referred to herein as a “prosthetic valve,” a “transcatheter heart valve,” or a “THV”) 300. As illustrated in FIGS. 1B, 5A-5D, and 13A-13B the implantable prosthetic valve 300 comprises an annular frame 310 defining a frame central passage 314. The annular frame 310 is radially expandable and contractable to transition the implantable prosthetic valve 300 between a delivery configuration and an operational configuration. Specifically, when in the delivery configuration, the implantable prosthetic valve 300 is sufficiently reduced in diameter to be sized for delivery through the patient’s vasculature. When in the operational configuration, the implantable prosthetic valve 300 is expanded in diameter so as to be operatively mounted at the target implantation site and so as to regulate a blood flow within the patient. The implantable prosthetic valve 300 may be described as being in the operational configuration even when theAttorney Docket No: THVMC-23753WO01 implantable prosthetic valve 300 is not positioned within the patient and / or at the target implantation site.

[0100] As illustrated in FIGS. 1B, 5A-5D, and 13A-13B, a valve delivery apparatus (also referred to herein as a “delivery apparatus” or “delivery assembly”) 200 can comprise a steerable guide catheter 210 and a balloon catheter 220 extending through the guide catheter 210 (also referred to herein as a “flex catheter,” a “flexible catheter,” and / or a “main catheter”). 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.

[0101] 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 flex catheter 210 has a distal end 216, where the tip 216 has a distal surface 218. 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.

[0102] With continued reference to FIGS. 1B, 5A-5D, and 13A-13B, the valve delivery apparatus 200 additionally comprises an inflatable balloon 230 (also referred to herein as a “balloon”) mounted on the balloon catheter 220 at a distal portion of the balloon catheter 220, which is opposite the proximal portion 222. As discussed in more detail below, the valve delivery apparatus 200 is generally configured such that the implantable prosthetic valve 300 is mounted to the valve delivery apparatus 200 in a crimped state to prepare the valve delivery apparatus 200 and the implantable prosthetic valve 300 for insertion into a patient’s vasculature.

[0103] In some examples as illustrated in FIGS. 1B, 5A-5D, and 13A-13B, the valve delivery apparatus 200 comprises a nose cone 240 that is mounted at a distal end of the valve delivery apparatus 200 to facilitate advancement of the valve delivery apparatus 200 through the patient's vasculature to the target implantation site. The nose cone 240 can be formed of any of a variety of materials, including various polymeric, metallic, and / or composite materials. AdditionalAttorney Docket No: THVMC-23753WO01 details of the valve delivery apparatus 200 can be found in PCT / US23 / 27476, which is incorporated by reference herein.

[0104] As discussed herein, prosthetic valve preparation generally comprises a crimper assembly (also referred to herein as a “crimping device”) 100 for crimping the implantable prosthetic valve 300 onto the balloon 230. A crimper assembly according to an example, and / or components thereof, is shown in FIG. 1A. 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 herein are described in at least U.S. Pat. No. 7,530,253 and PCT / US23 / 27476, the disclosures of which are incorporated by reference herein.

[0105] As illustrated in FIG. 1A, the crimper assembly 100 can comprise a base 112, a housing 110 fixedly mounted to the base 112, and a plurality of circumferentially arrayed nesting jaws 114 supported within the housing 110. More specifically, the housing 110 defines a crimper assembly central axis 102, and the jaws 114 are radially moveable within the housing 110 toward and away from the crimper assembly central axis 102. The jaws 114 collectively define a crimper aperture 130 that varies in diameter as the jaws 114 move toward and away from the crimper assembly central axis 102.

[0106] The crimper assembly 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 102, 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 114 radially away from the crimper assembly central axis 102. In some examples, a crimp stop 150 can be used to limit pivoting action of the actuator handle 120. Accordingly, when the implantable prosthetic valve 300 is positioned within the crimper aperture 130, actuating the actuator handle 120 to decreaseAttorney Docket No: THVMC-23753WO01 the diameter of the crimper aperture 130 can operate to crimp the implantable prosthetic valve 300.

[0107] Prior to fully crimping the implantable prosthetic valve 300 on the inflatable balloon 230, it is desirable to position the implantable prosthetic valve 300 at a desired crimping location. As such, an alignment tool can be used to adjust the relative position of the prosthetic valve 300 on the balloon 230. Alignment tools (for example the alignment tool 400, or any other alignment tool described herein) broadly comprise a stop surface against which a datum feature (also referred to herein as a “datum”) of a valve delivery apparatus can contact for alignment, where the datum feature can comprise any relatively rigid surface of the valve delivery apparatus.

[0108] As will be described herein, dimensions and sizes of the alignment tool can be specified to accommodate a specific implantable prosthetic valve and corresponding valve delivery apparatus. That is, specific prosthetic valves and corresponding valve delivery apparatuses can have complementary alignment tools. Alignment tools can be labeled accordingly, using indicia (e.g., colors, labels, etc.) to denote use with a particular prosthetic valve and / or valve delivery apparatus.

[0109] FIGS. 2-4 show an example of an alignment tool (also referred to herein as a “tool” or “alignment fixture”) 400 that can be used to position the prosthetic valve 300 on the balloon 230 prior to fully crimping the prosthetic valve 300 in place. The alignment tool 400 can comprise a main body (also referred to herein as a “tray”) 402 with a first end 410, a second end 412, a top surface 414, and an alignment surface 415 located at the first end 410. The alignment surface 415 can be perpendicular to the top surface 414 of the alignment tool 400. The top surface 414 can have a first recess 416 and a second recess 418, where the first and second recesses 416, 418 extend into the main body 402 away from the top surface 414. The first recess 416 extends to the alignment surface 415 and has a first edge 420 and a second edge 422 where the first recess 416 interfaces the top surface 414. The first and second edges 420, 422 can be rounded with varying radii.Attorney Docket No: THVMC-23753WO01

[0110] As shown in FIGS. 2-4, the alignment tool 400 can further comprise a wall 424 extending from the top surface 414 of the main body 402 at the first edge 420, where an inner surface 428 of the wall 424 and the main body 402 form a cavity 430. The cavity 430 can have a conical shape. A slot or gap 431 can remain between the wall 424 and the second edge 422 as shown in FIG. 2, providing visual access to the inner surface 428 of the wall 424 and the cavity 430.

[0111] In some examples, the wall 424 can also extend from the second edge 422, thereby enclosing the cavity 430 at both the first and second edges 420, 422. Additionally or alternatively to the slot 431, the wall 424 can have at least one window providing visual access to the cavity 430 from the outside.

[0112] The wall 424 can be replaced by a protrusion or block extending from at least a portion of the top surface 414, where an inner surface of the protrusion together with the main body 402 form the cavity 430. As such, an exterior profile of the protrusion can vary so long as the cavity 430 itself is dimensionally consistent.

[0113] In some examples, the main body 402 alone forms the cavity 430. For instance, the first recess 416 and / or the cavity 430 can have a shallow inset depth within the main body 402 or a deeper inset depth within the main body 402. With a shallow inset depth and a conical shaped cavity 430, an inner wall of the cavity 430 can span (e.g., up to 180 degrees) around the conical shape. With a deeper inset depth and a conical shaped cavity 430, the inner walls of the cavity 430 can span (e.g., greater than 180 degrees) around the conical shape, resulting in a partially enclosed, wrapped configuration.

[0114] The wall 424 can be formed integrally with the main body 402, by molding, 3D printing, or machining the alignment tool 400 as a single part. In some examples, the wall 424 can be fabricated separately and coupled to the main body 402 using bonding, thermal fusing, mechanical fasteners such as snaps, or combinations thereof. The alignment tool can be made of any of a variety of materials, including various polymeric, metallic, and / or composite materials. Some or all of edges of the alignment tool 400 can be manufactured with rounded finishes, reducing the likelihood that an edge will snag or tear contacting components.Attorney Docket No: THVMC-23753WO01

[0115] As described above, the cavity 430 can be configured to match an outer profile of a nose cone (for example, the nose cone 240, or any other nose cone described herein) of a valve delivery apparatus (for example, the delivery apparatus 200, or any other delivery apparatus described herein). As shown in FIGS. 2 and 4, the wall 424 is curved and the cavity 430 has a conical shape corresponding to a conical shape of a nose cone. For instance, the wall 424 can be curved to extend 35-135 degrees around the conical shape.

[0116] It is also possible to vary a length of the wall 424 (i.e., the cavity 430), where the length is a portion of the distance between the first and second ends 410, 412 of the main body 402.

[0117] In some examples, the first recess 416 is specified to match a portion of an outer profile of a corresponding balloon (for example, balloon 230, or any other balloon described herein). The first recess 416 can be sized to loosely fit the corresponding balloon, leaving space or slack around the corresponding balloon. Alternatively, the remaining portion of the first recess 416 can be sized to closely fit the corresponding balloon.

[0118] As seen in FIGS. 2 and 4, a stop surface 434 (also referred to herein as an “inner stop surface” or an “inner, annular surface”) is disposed at a distal end of the cavity 430, in some instances, located adjacent to the second recess 418. In some examples, the stop surface 434 is perpendicular to the top surface 414. The stop surface 434 can further have an aperture extending through its surface, forming a portion of the second recess 418 and accommodating a guide wire or a portion of a catheter therethrough. The stop surface 434 can be configured in size and shape to match a size and shape of a tip of the corresponding nose cone (for example, the nose cone 240, or any other nose cone described herein), where the nose cone is a datum feature (also referred to herein as a “datum”) and can contact the stop surface 434 for positioning. Alternatively, the stop surface 434 can be oversized or undersized compared to the tip of the corresponding nose cone.

[0119] In some examples, the alignment tool 400 comprises at least one indicator 440, where the at least one indicator 440 denotes a location of the stop surface 434 and is visible to a user. FIGS. 2-4 show the at least one indicator 440 as a line on the top surface 414 of the main bodyAttorney Docket No: THVMC-23753WO01 402, however, the main body can comprise any indicator on any portion of the alignment tool 400 that designates the location of the stop surface 434 to a user. For example, the indicator may comprise a visual marker, such as an indented or protruding line, arrow, or other indicia.

[0120] Additionally or alternatively, the indicator may further comprise an audible, haptic, or visible cue such as a light that activates when the stop surface 434 is engaged inside the cavity, as will be described herein further below. In other words, the alignment tool 400 may comprise a visual marker, such as an indented or protruding line, arrow, or other indicia, and / or an audible, haptic, and / or visible cue such as a light.

[0121] The main body 402 of the alignment tool 400 can comprise a bottom surface 442, where the bottom surface 442 can be rounded or flat as shown in FIGS. 2-4. In some examples, the alignment tool 400 can be mounted to a substrate, such as a laboratory or assembly area benchtop or table, a laboratory or assembly area device, or a portion of a crimping assembly (for example, the base 112 of the crimper assembly 100, or any other crimper assembly or portion thereof described herein).

[0122] In some instances, the bottom surface 442 can be permanently or removably attached, fastened, bonded, or fused to a substrate. As such, the bottom surface 442 can include means for fastening, bonding, or attaching the alignment tool 400 to the substrate, such as for example, snapping, hook and loop, fastener, or adhesive elements. Attachment elements can be located on portions of the bottom surface 442 or over the entire bottom surface 442.

[0123] In some examples, the alignment tool can be held by the user during an alignment operation and, as such, may have features to enable secure gripping or handling, such as for example, straps or finger holds.

[0124] The bottom surface 442 may further comprise features to orient the alignment tool 400 on a substrate at an angle. The bottom surface 442 may comprise ramps, protrusions, or other angling elements to position the alignment tool 400 and the top surface 414 at an angle with respect to a substrate or a mount. Heights of the ramps, protrusions, or other angling elements can be specified to yield a desired angular orientation in at least one plane or axis.Attorney Docket No: THVMC-23753WO01

[0125] In some examples, ramps, protrusions, or other angling elements are built into or are integrated as a single piece with the main body 402. For instance, the main body 402 itself can be formed with a ramped bottom surface 442 disposed at an angle with respect to the top surface 414.

[0126] In some examples, ramps, protrusions, or other angling elements can be separate components that are permanently or removably attached, fastened, bonded, or fused to the bottom surface 442. For example, the ramps, protrusions, or other angling elements can be attached by the user to portions of or the entire bottom surface 442 to suit the user’s unique preferences and / or ergonomics. The angling elements can be specified to ensure that a catheter of the delivery apparatus lays flat (i.e., parallel to a substrate, such as a laboratory or assembly area benchtop, table, or device). The ramps, protrusions, or other angling elements can be removed, reattached, and / or adjusted thereafter by the same user or a different user.

[0127] Additionally and / or alternatively, the alignment tool 400 can comprise features for rotationally aligning portions of a prosthetic valve, such as commissures or apices of a frame, onto a balloon of a delivery apparatus. For example, as will be described further herein below, the alignment tool 400 may comprise markings such as lines or other indicia to which commissures or other features of a prosthetic valve can be aligned rotationally about a longitudinal axis of the prosthetic valve.

[0128] Referring to FIGS. 5A-5B and as previously described, the crimper assembly 100 of FIG. 1A can be used to partially crimp the implantable prosthetic valve 300 in an intermediate configuration prior to fully crimping the implantable prosthetic valve 300 in a delivery configuration. FIG. 5A shows the implantable prosthetic valve 300 assembled onto the valve delivery apparatus 200 before an initial crimping operation. FIG. 5B shows the implantable prosthetic valve 300 after a partial crimping operation to the intermediate configuration, where a distal frame end 312 of the annular frame 310 of the prosthetic valve is positioned a distance D1 from a tip of the nose cone 240.Attorney Docket No: THVMC-23753WO01

[0129] Specifically, in such examples, the implantable prosthetic valve 300 in the intermediate configuration may be sized (e.g., in inner diameter) to engage the valve 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 shown in FIG. 5B and subsequently positioning the implantable prosthetic valve 300 at the desired crimping location may ensure that the implantable prosthetic valve 300 remains at the desired crimping location during a final crimping action.

[0130] 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 of the crimper assembly 100 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 crimper assembly 100 by using the crimp stop 150. Crimping action and crimp stops are described in PCT / US23 / 27476.

[0131] As shown in FIG. 5C, after crimping the implantable prosthetic valve 300 to the intermediate configuration, the valve delivery apparatus 200 can be inserted into a complementary alignment tool, for example, the alignment tool 400 as shown, or any other alignment tool described herein. As described above, the cavity 430 can be sized to accommodate and / or match an outer profile of the corresponding nose cone 240. The first recess 416 can be dimensioned to accommodate and / or match an outer profile of the corresponding balloon 230. The stop surface 434 can be sized and shaped to accommodate and / or match an outer envelope of the corresponding tip of the nose cone 240.

[0132] The valve delivery apparatus 200 can be inserted into the alignment tool 400 until the tip of the nose cone 240 contacts the stop surface 434. The at least one indicator 440 can visually indicate the location of the stop surface 434 to the user with respect to the nose cone 240 during insertion and, in some examples, the user can see the nose cone 240 through the slot 431 betweenAttorney Docket No: THVMC-23753WO01 the wall 424 and the second edge 422. As described above, the alignment tool 400 can comprise other indicators denoting when the tip of the nose cone 240 contacts the stop surface 434. The alignment tool 400 may alternatively or additionally have other windows through which the user can see the nose cone 240 within the cavity 430 and against the stop surface 434.

[0133] Once the valve delivery apparatus 200 is fully inserted into the alignment tool 400 such that the tip of the nose cone 240 contacts the stop surface 434, the prosthetic valve 300 can be translated axially along its longitudinal axis into abutment with the alignment surface 415. The alignment surface 415 is configured to engage the distal frame end 312 of the annular frame 310 of the implantable prosthetic valve 300. The distance D2 between the alignment surface 415 and the stop surface 434 on the alignment tool 400 dictates the relative position of the prosthetic valve 300 on the balloon 230. That is, the alignment surface 415 of the alignment tool 400 is configured such that, when the tip of the nose cone 240 contacts the stop surface 434 and the distal frame end 312 engages the alignment surface 415, the alignment surface 415 operates to position the implantable prosthetic valve 300 at the desired crimping location. In this way, the distance D2 can be specified to ensure that the prosthetic valve 300 is situated at the desired location on the balloon 230 for implantation in the body.

[0134] It is also possible that the prosthetic valve 300 can be rotated about its longitudinal axis such that portions of the prosthetic valve 300, such as leaflet commissures or apices of the frame 310, are rotationally aligned onto the balloon 230 of the delivery apparatus 200. For example, the alignment tool 400 may comprise markings such as lines or other indicia to which the commissures or other features can be aligned, ensuring rotational alignment with respect to the delivery apparatus 200.

[0135] Because the implantable prosthetic valve 300 is at least partially restricted from inadvertent translation relative to the inflatable balloon 230 due to partial crimping, the prosthetic valve 300 maintains its aligned axial and / or rotational position once in abutment with the alignment surface 415. As such, the valve delivery apparatus 200 can be removed from the alignment tool 400 and re-inserted into the crimper assembly 100. FIG. 5D illustrates theAttorney Docket No: THVMC-23753WO01 prosthetic valve 300 at the desired location on the balloon 230 in the delivery configuration after final crimping, where the prosthetic valve 300 is ready for insertion, delivery, and deployment at an implantation site.

[0136] In the example of FIGS. 2-4, the alignment tool 400 comprises a main body 402, where the main body 402, in some examples, can be attached to a substrate, surface, or device. As previously described, it is also possible that the alignment tool 400 can be held by the user. In some examples, an alignment tool can be in integrated directly into elements of a device, such as a crimper assembly, and more specifically, a crimp stop.

[0137] As seen in FIG. 1A, the crimp stop 150, which provides a manual rotation stop for the handle 120, is attached to the base 112 of the crimper assembly 100. The crimp stop 150 is therefore conveniently located for user access during preparation for and operation of the crimper assembly 100. FIGS. 6-9 illustrate an example of an alignment tool 500 that is coupled to or integrally formed in a single piece with the crimp stop 150 of the crimper assembly 100.

[0138] As shown in FIGS. 6-9, features of the alignment tool 500 correspond to features of the alignment tool 400 and reference numbers are labeled accordingly. In this way, feature descriptions for the alignment tool 400 apply to the corresponding features in the alignment tool 500 and are incorporated herein. For instance, alignment tool 500 comprises a wall 524, where descriptions regarding the wall 424 likewise apply to the wall 524.

[0139] In some examples, the alignment tool 500 can be fabricated separately and coupled to the crimp stop 150. The alignment tool 500 and / or the crimp stop 150 can be configured with mating features and / or surfaces to facilitate attachment. As shown in the example of FIG. 7, a side wall 550 of the alignment tool 500 can be configured to mate with a corresponding notch 554 in the crimp stop 150. Alternatively, the notch 554 can be formed into the main body 502 of the alignment tool 500. Interfacing surfaces between the alignment tool 500 and the crimp stop 150 can be attached and secured using bonding, thermal fusing, mechanical fasteners such as snaps, or combinations thereof. The alignment tool can be made of any of a variety of materials, including various polymeric, metallic, and / or composite materials.Attorney Docket No: THVMC-23753WO01

[0140] In other examples, the crimp stop 150 and / or the alignment tool 500 can be configured with features other than a notch that permit attachment of an alignment tool. Interfacing features and / or surfaces can comprise bonding, thermal fusing, mechanical fasteners such as snaps, or combinations thereof to secure the features and / or surfaces together.

[0141] In some examples, the alignment tool 500 can be fabricated integrally with the crimp stop 150 as a single piece by molding, 3D printing, or machining the alignment tool 500 directly into the crimp stop 150.

[0142] The alignment tool 500 can be centered in a lengthwise dimension about a centerline CL of the crimp stop 150, as shown in FIG. 8. Additionally, the alignment tool 500 can be oriented in a specified angular configuration with respect to the crimp stop 150 to improve user ergonomics and / or visibility. As shown in FIGS. 8-9, it may be desirable to orient the bottom surface 542 and therefore the top surface 514 at an angle with respect to the crimp stop 150 and the base 112 of the crimper assembly 100. FIG. 8 shows a first angle A1 disposed between an inner edge E1 of the bottom surface 542 and a horizontal plane P1, where the horizontal plane P1 is parallel to a substrate, such as the base 112 of the crimper assembly 100 and / or a laboratory or assembly area benchtop or table.

[0143] FIG. 9 illustrates a second angle A2 disposed between a front edge E2 of the bottom surface 542 and the horizontal plane P1. The first and second angles A1, A2 can be specified to yield an angular orientation of the alignment tool 500 with respect to the crimp stop, crimper assembly 100, substrate, or laboratory or assembly area benchtop or table that optimizes user ease and physical access. For example, the first and second angles A1, A2 can be specified to ensure a delivery apparatus and catheter thereof is flat while using the alignment tool 500. By orienting the alignment tool 500 in this way, the user may have improved visibility of the cavity 530, the stop surface 534, at least one indicator 540, and / or insertion into the alignment tool 500.

[0144] In some examples, when the alignment tool 500 is fabricated separately and coupled to the crimp stop 150, the alignment tool 500 and the crimp stop 150 comprise elements or features to encourage assembly in a specified angular orientation. For example, the notch 554 can beAttorney Docket No: THVMC-23753WO01 configured such that, when the alignment tool 500 is assembled, it fits with the crimp stop 150 at a specified angle.

[0145] In some examples, other features or indicia may be included to indicate angular orientation and placement of the alignment tool 500 with respect to the crimp stop 150. It is also possible in some instances, that the relative angular orientation can be adjusted to suit the preferences and needs of a particular user and / or be adjusted thereafter by the same user or a different user.

[0146] When the alignment tool 500 is fabricated integrally with the crimp stop 150 as a single piece, the angles A1 and A2 can be specified for fabrication, such that the resulting single piece results in the desired, relative angular orientation as prescribed.

[0147] In some examples, alignment tools can be configured with stop surfaces to interface with other datums of a valve delivery apparatus, where the datums can be any relatively rigid surface on the delivery apparatus. For instance, a distal surface of a flex catheter can be used as a datum feature for positioning a valve delivery apparatus with respect to an alignment tool.

[0148] FIGS. 10-12 illustrate an example of an alignment tool 600 comprising an alternative stop surface configuration. Dimensions and sizes of the alignment tool 600 can be specified to accommodate a specific implantable prosthetic valve and corresponding valve delivery apparatus. In other words, specific prosthetic valves and corresponding valve delivery apparatuses can have complementary alignment tools. Alignment tool 600 can be labeled accordingly, using indicia or colors to denote use with a particular prosthetic valve and / or valve delivery apparatus.

[0149] The alignment tool 600 comprises a main body 602 with a first end 610, a second end 612 located a distance from the first end, a top surface 614, an end surface 615 located at the first end 610, and an alignment surface 617 located at the second end 612. Outer sides of the alignment tool 600 extending between the first and second ends 610, 612 are shown in FIGS. 10- 12 as being rounded or circular, but the sides can be alternatively squared off. An outer envelopeAttorney Docket No: THVMC-23753WO01 of the main body 602, including a diameter and / or width can vary depending on a shape and size of the corresponding valve delivery device.

[0150] The alignment surface 617 can be perpendicular to the top surface 614 of the alignment tool 600. The top surface 614 can have a first recess 616 and a second recess 618, where the first and second recesses 616, 618 extend into the main body 602 away from the top surface 614. The first recess 616 can extend to the end surface 615 and have a first edge 620 and a second edge 622 where the first recess 616 interfaces with the top surface 614. The second recess 618 can extend to the alignment surface 617 and have a first edge 621 and a second edge 623 where the first recess 616 interfaces the top surface 614.

[0151] As shown in FIGS. 10-12, the alignment tool 600 can further comprise a wall 624 extending from the top surface 614 of the main body 602 at the first edge 620, where an inner surface 628 of the wall 624 together with the main body 602 forms a cavity 630.

[0152] A slot or gap can remain between the wall 624 and the second edge 622, or in some examples, the wall 624 can also extend from the second edge 622, thereby partially or fully enclosing the cavity 630 at both the first and second edges 620, 622. Additionally or alternatively to a slot or gap, the wall 624 can have at least one window providing visual access to the cavity 630 from the outside.

[0153] The wall 624 can be replaced by a protrusion or a block extending from at least a portion of the top surface 614, where an inner surface of the protrusion or block together with the main body 602 forms the cavity 630. As such, an exterior profile of the protrusion can vary so long as the cavity 630 itself within is dimensionally consistent.

[0154] In some examples, the main body 602 alone forms the cavity 630. The first recess 616 and / or the cavity 630, can have a shallow inset depth within the main body 602 or a deeper inset depth within the main body 602. With a shallow inset depth and a conical or cylindrically shaped cavity 630, an inner wall of the cavity 630 can span (e.g., up to 180 degrees) around the conical / cylindrical shape. With a deeper inset depth and a conical or cylindrically shaped cavityAttorney Docket No: THVMC-23753WO01 630, the inner walls of the cavity 630 can span (e.g., greater than 180 degrees) around the conical shape, resulting in a partially enclosed, wrapped configuration.

[0155] The wall 624 can be formed integrally with the main body 602, by molding, 3D printing, or machining the alignment tool 600 as a single part. In some examples, the wall 624 can be fabricated separately and coupled to the main body 602 using bonding, thermal fusing, mechanical fasteners such as snaps, or combinations thereof. The alignment tool can be made of any of a variety of materials, including various polymeric, metallic, and / or composite materials. Some or all of edges of the alignment tool 600 can be manufactured with rounded finishes, for example as shown for edges 621 and 623, reducing the likelihood that an edge will snag or tear contacting components.

[0156] As described above, the cavity 630 can be configured to match and / or accommodate an outer profile of a distal end a flexible catheter (for example, the distal end 216 of the flex catheter 210, or any flex catheter described herein) of a valve delivery apparatus (for example, the delivery apparatus 200, or any delivery apparatus described herein).

[0157] As shown in FIGS. 10-12, the wall 624 is shown curved and the cavity 630 has a shape corresponding to a distal end of a flex catheter, shown as conical. The wall 624 can be curved to extend 35-135 degrees around the conical shape. It is also possible to vary a length of the wall 624 (i.e., the cavity 630), where the length is a portion of the distance between the first and second ends 610, 612 of the main body 602.

[0158] The first recess 616 can be specified to match an outer profile of the flex catheter (for example, flex catheter 210, or any other flexible catheter described herein). The first recess 616 can be sized to loosely fit the corresponding flex catheter, leaving space or slack around the corresponding flex catheter. Alternatively, the first recess 616 can be sized to closely fit the corresponding flex catheter.

[0159] As seen in FIG. 10, the cavity 630 comprises a stop surface 634 (also referred to herein as an “inner stop surface” or an “inner, annular surface”), located adjacent to the second recess 618. In some examples, the stop surface 634 is perpendicular to the top surface 614. The stop surfaceAttorney Docket No: THVMC-23753WO01 634 can further have an aperture extending through its surface, forming a portion of the second recess 618 and accommodating other portions of a valve delivery apparatus therethrough.

[0160] The stop surface 634 can be configured in size and shape to match a size and / or shape of a distal surface of the corresponding flex catheter (for example, the distal surface 218), where the distal surface is a datum that can contact and bottom-out on the stop surface 634 for locating and positioning. Alternatively, the stop surface 634 can be oversized or undersized compared to the size and shape of the corresponding distal surface of the flex catheter.

[0161] The second recess 618 is specified to match and / or accommodate a portion of an outer profile of a corresponding balloon (for example, the balloon 230, or any other balloon described herein). The second recess 618 can be sized to loosely fit the corresponding balloon, leaving space or slack around the corresponding balloon. Alternatively, the second recess 618 can be sized to closely fit the corresponding balloon.

[0162] In some instances, the distance between the first and seconds ends 610, 612 of the main body 602 can vary depending on a shape and size of the corresponding valve delivery device.

[0163] The alignment tool 600 can comprises at least one indicator 640, where the at least one indicator 640 denotes a location of the stop surface 634 and is visible to a user. FIGS. 10-12 show the at least one indicator 640 as a protrusion disposed on the top surface 614 of the main body 602 and wrapping around the main body 602. The main body 602 can comprise any indicator on any portion of the alignment tool 600 that designates the location of the stop surface 634 to a user. For example, the indicator may comprise a visual marker, such as an indented or protruding line, arrow, or other indicia.

[0164] Additionally or alternatively, the indicator may further comprise an audible, haptic, or visible cue such as a light that activates when the stop surface 634 is engaged inside the cavity, as will be described further later herein. In other words, the alignment tool 600 may comprise a visual marker, such as an indented or protruding line, arrow, or other indicia, and / or an audible, haptic, and / or visible cue such as a light.Attorney Docket No: THVMC-23753WO01

[0165] The alignment tool 600 may also comprise markers 660 denoting relative position of a balloon catheter, as will be described herein below. The alignment tool may also have words on the top surface 614 or elsewhere on the main body 602 denoting an orientation of use (e.g., where to position a flex catheter or a balloon).

[0166] The main body 602 of the alignment tool 600 comprises a bottom surface 642, where the bottom surface 642 can be rounded or flat as shown in FIGS. 10-12. In some examples, the alignment tool 600 can be mounted to a substrate, such as a laboratory or assembly area benchtop or table, a laboratory or assembly area device, or a portion of a crimping assembly (for example, base 112 of the crimper assembly 100, or any other crimper assembly or portion thereof described herein).

[0167] In some instances, the bottom surface 642 can be permanently or removably attached, fastened, bonded, or fused to a substrate in the same manner as previously discussed for the alignment tool 400, which is incorporated herein for the alignment tool 600.

[0168] In some examples, the alignment tool 600 can be held by the user during an alignment operation and, as such, may have features to enable secure gripping or handling, such as for example, straps or finger holds.

[0169] The bottom surface 642 may further comprise features to orient the alignment tool 600 on a substrate at an angle in the same manner as previously discussed for the alignment tool 400, which is incorporated herein for the alignment tool 600.

[0170] Additionally, the alignment tool 600 can comprise features for aligning portions of a prosthetic valve, such as leaflet commissures or apices of a frame, rotationally onto a balloon of a delivery apparatus. For example, the alignment tool 600 may comprise markings such as lines or other indicia to which leaflet commissures or other features of a prosthetic valve can be aligned rotationally about a longitudinal axis of the prosthetic valve.

[0171] As previously described for FIGS. 5A-5B, the implantable prosthetic valve 300 can be crimped to the intermediate configuration. FIG. 13A shows the implantable prosthetic valve 300 partially crimped on the balloon 230, where an end 316 of the prosthetic valve 300 is a distanceAttorney Docket No: THVMC-23753WO01 D3 from the distal surface 218 of the flex catheter 210. In some examples, the balloon catheter shaft 226 can comprise at least one marker 228 as seen in FIG. 13A.

[0172] As shown in FIG. 13B, after crimping the implantable prosthetic valve 300 to the intermediate configuration, the valve delivery apparatus 200 can be inserted into a complementary alignment tool, for example the alignment tool 600. As described above, the cavity 630 can be sized to accommodate and / or match an outer profile of the distal end 216 of the flex catheter 210. The second recess 618 can be dimensioned to accommodate and / or match an outer profile of the balloon 230 and the balloon catheter shaft 226. The stop surface 634 can be sized and shaped to accommodate and / or match a size and shape of the distal surface 218 of the corresponding flex catheter 210.

[0173] The valve delivery apparatus 200 can be inserted into the alignment tool 600 until the distal surface 218 contacts the stop surface 634. The at least one marker 228 on the balloon catheter shaft 226 can be aligned with the markers 660 on the alignment tool 600, thus adjusting the relative position of the balloon 230 with respect to the alignment tool 600 and the stop surface 634.

[0174] The at least one indicator 640 can visually indicate the location of the stop surface 634 to the user with respect to the distal surface 218 during insertion and, in some examples, the user can see the distal surface 218 through a slot or window. As described above, the alignment tool 600 can comprise other indicators denoting when the distal surface 218 contacts the stop surface 634.

[0175] Once the valve delivery apparatus 200 is fully inserted into the alignment tool 600 such that the distal surface 218 contacts the stop surface 634, the prosthetic valve 300 can be translated axially along its longitudinal axis into abutment with the alignment surface 617. The alignment surface 617 is configured to engage the end 316 of the implantable prosthetic valve 300.

[0176] The distance D4 between the alignment surface 617 and the stop surface 634 on the alignment tool 600 dictates the relative position of the prosthetic valve 300 on the balloon 230.Attorney Docket No: THVMC-23753WO01 In other words, the alignment surface 617 of the alignment tool 600 is configured such that, when the distal surface 218 contacts the stop surface 634 and the end 316 of the prosthetic valve 300 engages the alignment surface 617, the alignment surface 617 operates to position the implantable prosthetic valve 300 at the desired crimping location. In this way, the distance D4 can be specified to ensure that the prosthetic valve 300 is situated at the desired final location on the balloon 230 for implantation in the body.

[0177] The prosthetic valve 300 can also be rotated about its longitudinal axis such that portions of the prosthetic valve 300, such as commissures or apices of the frame 310, are rotationally aligned on the balloon 230 of the delivery apparatus 200. For example, the alignment tool 600 may comprise markings such as lines or other indicia to which the commissures or other features are aligned, ensuring rotational alignment with respect to the delivery apparatus 200.

[0178] Because the implantable prosthetic valve 300 is at least partially restricted from inadvertent translation relative to the inflatable balloon 230 due to partial crimping, the prosthetic valve 300 maintains its aligned axial and / or rotational position once in abutment with the alignment surface 617. As such, the valve delivery apparatus 200 can be removed from the alignment tool 600 and re-inserted into the crimper assembly 100 for a final crimping operation as previously described with respect to FIG. 5D.

[0179] As previously described with respect to FIGS. 6-9, an alignment tool can be integrated directly into elements of a device, such as a crimper assembly, and more specifically, a crimp stop component. FIGS. 14-17 illustrate an example of an alignment tool 700 that is coupled to or integrally formed in a single piece with the crimp stop 150 of the crimper assembly 100. The alignment tool 700 can use a distal surface (such as the distal surface 218, for example) of a flexible catheter (such as the flex catheter 210, for example, or any other flex catheter described herein) as a datum feature for positioning against a stop surface.

[0180] As shown in FIGS. 14-17, features of the alignment tool 700 correspond to features of other alignment tools (for example, the alignment tool 600, or any other alignment tool described herein) and reference numbers are labeled accordingly. In this way, feature descriptions forAttorney Docket No: THVMC-23753WO01 corresponding features in other alignment tools apply to the alignment tool 700 and are incorporated herein for the alignment tool 700. For instance, the alignment tool 700 comprises a wall 724, where descriptions regarding the wall 624 likewise apply to the wall 724.

[0181] In some examples, the alignment tool 700 can be fabricated separately and coupled to the crimp stop 150. The alignment tool 700 and / or the crimp stop 150 can be configured with mating features and / or surfaces to facilitate attachment. As shown in the example of FIG. 15, a side wall 750 of the alignment tool 700 can be configured to mate with a corresponding notch 754 in the crimp stop 150. Alternatively, the notch 754 can be formed into the main body 702 of the alignment tool 700. Interfacing surfaces between the alignment tool 700 and the crimp stop 150 can be attached and secured using bonding, thermal fusing, mechanical fasteners such as snaps, or combinations thereof. The alignment tool can be made of any of a variety of materials, including various polymeric, metallic, and / or composite materials.

[0182] In other examples, the crimp stop 150 can be configured with features other than a notch that permit attachment of an alignment tool. Interfacing features and / or surfaces can comprise bonding, thermal fusing, mechanical fasteners such as snaps, or combinations thereof to secure the features and / or surfaces together.

[0183] In some examples, the alignment tool 700 can be fabricated integrally with the crimp stop 150 as a single piece by molding, 3D printing, or machining the alignment tool 700 directly into the crimp stop 150.

[0184] The alignment tool 700 can be centered in a lengthwise dimension about a centerline CL of the crimp stop 150, as shown in FIG. 16. The alignment tool 700 can be oriented in a specified angular configuration with respect to the crimp stop 150, to improve user ergonomics and / or visibility. It may be desirable to orient the bottom surface 742 and therefore the top surface 714 at an angle with respect to the crimp stop 150 and the base 112 of the crimper assembly 100. FIG. 16 shows a third angle A3 disposed between an edge E3 of the bottom surface 742 of the main body 702 and a horizontal plane P2, where the horizontal plane P2 isAttorney Docket No: THVMC-23753WO01 parallel to a substrate, such as the base 112 of the crimper assembly 100 and / or a laboratory or assembly area benchtop or table.

[0185] FIG. 17 illustrates a fourth angle A4 disposed between a centerline 762 of the cavity 716 projected along the top surface 714 and an intersection of the top surface 714 and a vertical plane P3, where the vertical plane P3 is perpendicular to both the horizontal plane P2 and a vertical plane extending through the crimp stop centerline CL.

[0186] The third and fourth angles A3, A4 can be specified to yield an angular orientation of the alignment tool 700 with respect to a substrate, the crimp stop, crimper assembly 100, or laboratory or assembly area benchtop or table that optimizes user ease and physical access. For example, the third and fourth angles A3, A4 can be specified to ensure that a delivery apparatus and catheter is flat during insertion into the alignment tool 700. By orienting the alignment tool 700 in this way, the user may have improved visibility of the cavity 730, the stop surface 734, at least one indicator 740, markers 760 and / or insertion into the alignment tool 700.

[0187] In some examples, when the alignment tool 700 is fabricated separately and coupled to the crimp stop 150, the alignment tool 700 and the crimp stop 150 comprise elements or features to encourage assembly in a specified angular orientation. For example, the notch 754 can be configured such that, when the alignment tool 700 is assembled to the crimp stop 150, the alignment tool 700 is disposed at the specified angle.

[0188] In some examples, other features or indicia may be included to indicate angular orientation and placement of the alignment tool 700 with respect to the crimp stop 150. It is also possible in some instances, that the relative angular orientation can be adjusted to suit the preferences and needs of a particular user and / or be adjusted thereafter by the same user or a different user.

[0189] When the alignment tool 700 is fabricated integrally with the crimp stop 150 as a single piece, the angles A3 and A4 can be specified for fabrication, such that the resulting single piece yields the desired, relative angular orientation as prescribed.Attorney Docket No: THVMC-23753WO01

[0190] As described above, specific prosthetic valves and corresponding valve delivery apparatuses can have complementary alignment tools. Specific prosthetic valves can also have corresponding crimp stops. Crimp stops with mating / corresponding alignment tools can be labeled accordingly, using indicia or colors to denote use with a particular prosthetic valve and / or valve delivery apparatus.

[0191] In some examples, crimp stops and corresponding alignment tools can be part of a kit, where the kit is specified for a particular prosthetic valve and comprises components needed for crimping and assembling that specific prosthetic valve. For example, prosthetic valves intended for use with a mitral valve can have a corresponding mitral prosthetic valve kit comprising a specific mitral valve alignment tool and crimp stop. The kit can also include the prosthetic valve and / or corresponding delivery apparatus, coupling elements, and / or ramps, protrusions, or other angling elements for user customization.

[0192] FIG. 18 is a flow chart illustrating an example method 800 of using an alignment tool (for example, alignment tools 400, 500, 600, 700 or any alignment tool herein) for positioning and crimping an implantable prosthetic valve onto an inflatable balloon as a part of a prep procedure prior to entering the patient’s vasculature. The method 800 detailed in FIG. 18 is not exhaustive, but representative of one such example method. Method 800 may comprise other steps not detailed herein. Although the method 800 described is primarily directed to prosthetic heart valves, the method can be used with various other prosthetic implants, including for instance, stents.

[0193] At 810, the method 800 can comprise inserting a balloon catheter of a valve delivery apparatus within central passage of an implantable prosthetic valve, where the prosthetic valve comprises an annular frame. For example, the inserting the balloon catheter within the frame central passage at 810 may comprise longitudinally sliding the implantable prosthetic valve onto the distal portion of the valve delivery apparatus, such as to position the implantable prosthetic valve around the inflatable balloon.Attorney Docket No: THVMC-23753WO01

[0194] At 820, the method 800 can comprise inserting the valve delivery apparatus with the balloon catheter and the implantable prosthetic valve thereon in a crimper assembly. At 830, the method can comprise partially crimping the annular frame of the implantable prosthetic valve with the crimper assembly. As discussed herein, the crimper assembly may be utilized to partially crimp the annular frame of the implantable prosthetic valve to bring the implantable prosthetic valve to an intermediate configuration, in which the implantable prosthetic valve may be selectively but deliberately positioned along the balloon of the valve delivery apparatus. As discussed herein, the partially crimping the annular frame at 830 may comprise radially compressing the implantable prosthetic valve to bring the annular frame to a diameter, such as may be defined by a diameter of the crimper aperture.

[0195] At 840, the method 800 can comprise inserting the valve delivery apparatus with the balloon catheter and the partially crimped prosthetic valve thereon into a cavity of an alignment tool. At 850, the user can translate the valve delivery apparatus within the cavity of the alignment tool such that a datum feature on the valve delivery apparatus (such as for example a distal tip of the nose cone 240, or distal surface 218, or any other datum feature described herein) abuts a stop surface.

[0196] After the datum feature of the valve delivery apparatus is in abutment with the stop surface, the partially crimped prosthetic valve can be translated in 860 toward an alignment surface on the alignment tool. In this step, an end of the frame of the prosthetic valve comes into abutment with the alignment surface of the alignment tool.

[0197] In 870, the method 800 can comprise inserting the valve delivery apparatus with the balloon catheter and the aligned partially crimped prosthetic valve back into the crimper assembly.

[0198] The crimper assembly 100 is utilized to fully crimp the implantable prosthetic valve 300 to the delivery apparatus 200 in 880, bringing the implantable prosthetic valve to a delivery configuration at a desired location on the balloon. In this way, the implantable prosthetic valveAttorney Docket No: THVMC-23753WO01 300 can engage the inflatable balloon 230 sufficiently tightly such that the implantable prosthetic valve 300 is restricted from translating relative to the inflatable balloon 230.

[0199] In this way, an alignment tool (such as alignment tools 400, 500, 600, and 700, or any alignment tool described herein) can position a prosthetic implant, such as for example a prosthetic valve or a stent, on a portion of a delivery apparatus, for example an expandable balloon, at a desired location as a part of a prep procedure before insertion in a body or delivery to an implantation site. In some examples, the disclosed alignment tool can be used to position a prosthetic implant on a delivery apparatus at a location away from an inflation balloon. Examples of “off-balloon” crimping can be found in U.S. Pat. No. 9,393,110.

[0200] By mounting and positioning an implantable prosthetic implant onto a balloon prior to entering the patient’s vasculature, the reliability and ease of implanting the prosthetic implant at the desired implantation site can be improved. Delivery Techniques

[0201] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Additionally and / or alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Additionally and / or alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through aAttorney Docket No: THVMC-23753WO01 partial J-sternotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve. In some examples, the prosthetic implant can be delivered via carotid and subclavian access.

[0202] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Additionally and / or alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0203] 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.

[0204] 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 chestAttorney Docket No: THVMC-23753WO01 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.

[0205] 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.

[0206] Sterilization

[0207] 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

[0208] 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.

[0209] Example 1. An alignment tool for locating a prosthetic implant on a delivery apparatus, the alignment tool comprising: a stop surface, wherein the stop surface engages the delivery apparatus; and an alignment surface disposed a distance from the stop surface, wherein theAttorney Docket No: THVMC-23753WO01 alignment surface is configured to abut a portion of the prosthetic implant and align the prosthetic implant relative to the delivery apparatus.

[0210] Example 2. The alignment tool of any example herein, particularly example 1, wherein the alignment tool further comprises a cavity configured to receive a portion of the delivery apparatus.

[0211] Example 3. The alignment tool of any example herein, particularly example 2, wherein the stop surface at least partially defines the cavity.

[0212] Example 4. The alignment tool of any example herein, particularly any one of examples 1-3, further comprising an indicator configured to specify a location of the stop surface.

[0213] Example 5. The alignment tool of any example herein, particularly any one of examples 1-4, further comprising features for rotationally aligning the prosthetic implant.

[0214] Example 6. The alignment tool of any example herein, particularly any one of examples 1-5, wherein the alignment tool rests on a top surface of a substrate.

[0215] Example 7. The alignment tool any example herein, particularly example 6, wherein the alignment tool is positioned at an angle relative to the top surface of the substrate.

[0216] Example 8. The alignment tool of any example herein, particularly any one of examples 1-7, wherein the prosthetic implant is a prosthetic heart valve or a stent.

[0217] Example 9. An alignment tool for a prosthetic implant, the alignment tool comprising: a main body with a top surface, a first end, a second end spaced apart from the first end by the top surface, and a cavity formed in the top surface, wherein the main body comprises a stop surface, and wherein the stop surface at least partially defines the cavity and is configured for contacting a delivery apparatus, and wherein the first end of the main body forms an alignment surface configured for contacting the prosthetic implant.

[0218] Example 10. The alignment tool of any example herein, particularly example 9, wherein the stop surface contacts a distal surface of a flexible catheter of the delivery apparatus.

[0219] Example 11. The alignment tool of any example herein, particularly example 9, wherein the stop surface contacts a tip of a nose cone of the delivery apparatus.Attorney Docket No: THVMC-23753WO01

[0220] Example 12. The alignment tool of any example herein, particularly any one of examples 9-11, wherein the alignment surface is perpendicular to the top surface of the main body.

[0221] Example 13. The alignment tool of any example herein, particularly any one of examples 9-12, further comprising a wall extending from the top surface of the main body, wherein the wall is disposed between the first end of the main body and the second end of the main body along at least a portion of the top surface.

[0222] Example 14. The alignment tool of any example herein, particularly example 13, wherein the wall forms at least a portion of the cavity.

[0223] Example 15. The alignment tool of any example herein, particularly any one of examples 13-14, wherein the wall forms a slot or a window.

[0224] Example 16. The alignment tool of any example herein, particularly any one of examples 13-15, wherein the wall is curved.

[0225] Example 17. The alignment tool of any example herein, particularly any one of examples 9-16, wherein the stop surface surrounds an aperture.

[0226] Example 18. The alignment tool of any example herein, particularly any one of examples 9-17, wherein the stop surface is perpendicular to the top surface of the main body.

[0227] Example 19. The alignment tool of any example herein, particularly any one of examples 9-18, wherein the cavity has a conical shape.

[0228] Example 20. The alignment tool of any example herein, particularly any one of examples 9-19, wherein the prosthetic implant is a prosthetic heart valve or a stent.

[0229] Example 21. An assembly comprising: a crimp stop; and the alignment tool of any example herein, particularly any one of examples 1-20, wherein the alignment tool is coupled to the crimp stop.

[0230] Example 22. The assembly of any example herein, particularly example 21, wherein the assembly is configured to attach to a crimper assembly.

[0231] Example 23. The assembly of any example herein, particularly example 22, wherein a portion of the alignment tool rests on a top surface of the crimper assembly.Attorney Docket No: THVMC-23753WO01

[0232] Example 24. The assembly of any example herein, particularly any one of examples 21- 23, wherein the alignment tool and the crimp stop are formed as a single, integral piece.

[0233] Example 25. The assembly of any example herein, particularly any one of examples 21- 23, wherein the alignment tool and the crimp stop are formed as separate, attached pieces.

[0234] Example 26. The assembly of any example herein, particularly example 25, wherein the alignment tool and the crimp stop are attached using bonding, fusing, heat welding, mechanical fastening, or combinations thereof.

[0235] Example 27. A method of aligning a prosthetic implant on a delivery apparatus, the method comprising: inserting a portion of a delivery apparatus into a cavity of an alignment tool; positioning a datum of the delivery apparatus within the cavity and into contact with an inner surface, wherein the inner surface at least partially defines the cavity; and advancing the prosthetic implant over the delivery apparatus and into contact with an alignment surface of the alignment tool.

[0236] Example 28. The method of any example herein, particularly example 27, wherein the datum is a tip of a nose cone.

[0237] Example 29. The method of any example herein, particularly example 27, wherein the datum is a distal surface of a flexible catheter.

[0238] Example 30. The method of any example herein, particularly any one of examples 27- 29, further comprising visualizing the datum through a slot or a window in the alignment tool.

[0239] Example 31. The method of any example herein, particularly any one of examples 27- 30, wherein the prosthetic implant is a prosthetic valve or a stent.

[0240] Example 32. The method of any example herein, particularly any one of examples 27- 31, further comprising crimping the prosthetic implant on the delivery apparatus before inserting the portion of the delivery apparatus into the cavity of the alignment tool.

[0241] Example 33. The method of any example herein, particularly any one of examples 27- 32, further comprising crimping the prosthetic implant on the delivery apparatus after removing the delivery apparatus from the alignment tool.Attorney Docket No: THVMC-23753WO01

[0242] Example 34. The method of any example herein, particularly any one of examples 27- 33, further comprising aligning a portion of the prosthetic implant rotationally relative to the alignment tool.

[0243] Example 35. The method of any example herein, particularly any one of examples 27- 34, wherein the alignment tool comprises at least one indicator signaling when the datum abuts the inner surface.

[0244] Example 36. A kit for a prosthetic implant preparation assembly, the kit comprising: a crimp stop; and an alignment tool, wherein the alignment tool and the crimp stop are configured for a specific prosthetic implant size and corresponding implant delivery apparatus.

[0245] Example 37. The kit of any example herein, particularly example 36, wherein the alignment tool is removably coupled to the crimp stop.

[0246] Example 38. The kit of any example herein, particularly example 36, wherein the alignment tool is permanently coupled to the crimp stop.

[0247] Example 39. The kit of any example herein, particularly any one of examples 36-38, further comprising coupling elements for securing the alignment tool to the crimp stop.

[0248] Example 40. The kit of any one any example herein, particularly any one of examples 36-39, further comprising coupling elements for securing the alignment tool, the crimp stop, or both the alignment tool and the crimp stop to a substrate.

[0249] Example 41. The kit of any example herein, particularly any one of examples 36-40, further comprising ramps, protrusions, or other angling elements.

[0250] Example 42. The kit of any example herein, particularly any one of examples 36-41, further comprising the corresponding prosthetic implant.

[0251] Example 43. The kit of any example herein, particularly any one of examples 36-42, wherein the prosthetic implant is a prosthetic valve or a stent.

[0252] Example 44. A method comprising sterilizing the prosthetic heart valve, apparatus, alignment tool, and / or assembly of any example.Attorney Docket No: THVMC-23753WO01

[0253] Example 45. A prosthetic heart valve, apparatus, alignment tool, and / or assembly of any one of examples 1-44, wherein the prosthetic heart valve and related apparatus, alignment tool, and / or assemblies, and tools are sterilized.

[0254] 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 alignment tool can be combined with any one or more features of another alignment tool. As another example, any one or more features of one delivery apparatus or assembly can be combined with any one or more features of another delivery apparatus or assembly.

[0255] 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

Attorney Docket No: THVMC-23753WO01 CLAIMS:

1. An alignment tool for locating a prosthetic implant on a delivery apparatus, the alignment tool comprising: a stop surface, wherein the stop surface engages the delivery apparatus; and an alignment surface disposed a distance from the stop surface, wherein the alignment surface is configured to abut a portion of the prosthetic implant and align the prosthetic implant relative to the delivery apparatus.

2. The alignment tool of claim 1, wherein the alignment tool further comprises a cavity configured to receive a portion of the delivery apparatus.

3. The alignment tool of claim 2, wherein the stop surface at least partially defines the cavity.

4. The alignment tool of any one of claims 1-3, further comprising an indicator configured to specify a location of the stop surface.

5. The alignment tool of any one of claims 1-4, further comprising features for rotationally aligning the prosthetic implant.

6. The alignment tool of any one of claims 1-5, wherein the prosthetic implant is a prosthetic heart valve or a stent.

7. An assembly comprising: a crimp stop; and the alignment tool of any one of claims 1-6, wherein the alignment tool is coupled to the crimp stop.Attorney Docket No: THVMC-23753WO01 8. The assembly of claim 7, wherein the assembly is configured to attach to a crimper assembly.

9. The assembly of claim 8, wherein a portion of the alignment tool rests on a top surface of the crimper assembly.

10. The assembly of any one of claims 7-9, wherein the alignment tool and the crimp stop are formed as a single, integral piece.

11. The assembly of any one of claims 7-9, wherein the alignment tool and the crimp stop are formed as separate, attached pieces.

12. A method of aligning a prosthetic implant on a delivery apparatus, the method comprising: inserting a portion of a delivery apparatus into a cavity of an alignment tool; positioning a datum of the delivery apparatus within the cavity and into contact with an inner surface, wherein the inner surface at least partially defines the cavity; and advancing the prosthetic implant over the delivery apparatus and into contact with an alignment surface of the alignment tool.

13. The method of claim 12, wherein the datum is a tip of a nose cone.

14. The method of claim 12, wherein the datum is a distal surface of a flexible catheter.Attorney Docket No: THVMC-23753WO01 15. The method of any one of claims 12-14, wherein the prosthetic implant is a prosthetic valve or a stent.

16. The method of any one of claims 12-15, further comprising crimping the prosthetic implant on the delivery apparatus after removing the delivery apparatus from the alignment tool.

17. The method of any one of claims 12-16, further comprising aligning a portion of the prosthetic implant rotationally relative to the alignment tool.

18. A kit for a prosthetic implant preparation assembly, the kit comprising: a crimp stop; and an alignment tool, wherein the alignment tool and the crimp stop are configured for a specific prosthetic implant size and corresponding implant delivery apparatus.

19. The kit of claim 18, wherein the alignment tool is removably coupled to the crimp stop.

20. The kit of claim 18, wherein the alignment tool is permanently coupled to the crimp stop.

21. The kit of any one of claims 18-20, further comprising the corresponding prosthetic implant.

22. The kit of any one of claims 18-21, wherein the prosthetic implant is a prosthetic valve or a stent.

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