Crimp alignment procedures and devices for prosthetic implants

Abstract

Assemblies for crimping a prosthetic implant on a target crimping location relative to a delivery apparatus is provided, as well as components of the assemblies and methods of using the assemblies and components thereof. An assembly can include an alignment guide and an implant alignment device. The alignment guide can include a positioning element configured to receive a delivery apparatus for a prosthetic implant and a mounting element configured to releasably secure the alignment guide to a portion of a crimping device. The assembly can also include an implant alignment device configured to fit, at least partially, within the cavity defined by the alignment guide mounting portion.

Description

Attorney Docket No: THVMC-23892WO01CRIMP ALIGNMENT PROCEDURES AND DEVICES FOR PROSTHETIC IMPLANTSCROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 717,454, filed November 7, 2024, which is incorporated by reference herein in its entirety.FIELD

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

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.SUMMARY

[0004] Described herein are prosthetic implants, delivery apparatus, and methods for crimping prosthetic implants on to delivery apparatus. The disclosed prosthetic implants, delivery apparatus, and methods can, for example, provide automation and accuracy in the crimping process and the resulting placement of the implant. As such, the devices and methods disclosedAttorney Docket No: THVMC-23892WO01 herein can, among other things, overcome one or more of the deficiencies of typical prosthetic implants and their delivery apparatus.

[0005] In some examples, an alignment assembly for crimping a prosthetic implant, comprises: an alignment guide comprising a mounting element defining an inner cavity and an outer surface, wherein the outer surface is positioned radially outward from the inner cavity and comprises one or more engagement members configured to secure the mounting element to a crimping device; and an implant alignment device moveably coupled to the mounting element and comprising a support portion and a coupling portion, wherein the support portion is configured to support a prosthetic implant on a distal end portion and extend at least partially within a central channel of the crimping device, and wherein the coupling portion is configured to extend at least partially within the inner cavity of the mounting element such that the implant alignment device and the mounting element are slidable relative to one another.

[0006] In some examples, the alignment assembly further comprises a spacer sized and shaped to fit within the inner cavity of the mounting element and configured to maintain the implant alignment device at a desired position within the inner cavity of the mounting element.

[0007] In some examples, the alignment guide further comprises a positioning element coupled to a proximal end portion of the mounting element and configured to receive a shaft portion of a distal end portion of a delivery apparatus for a prosthetic implant and prevent axial and radial movement relative to the positioning element.

[0008] In some examples, the positioning element and the mounting element are two separate elements which are removably coupled to one another.

[0009] In some examples, the positioning element of the alignment guide further comprises one or more retention members.

[0010] In some examples, the alignment assembly further comprises one or more clips extending in a proximal direction from the mounting element and a distal wall of the positioning element with one or more notches, wherein the one or more clips are configured to couple with the one or more notches.Attorney Docket No: THVMC-23892WO01

[0011] In some examples, an internal surface of the mounting element comprises one or more rails and an outer surface of the implant alignment device comprises one or more slots sized and shaped to fit the one or more rails.

[0012] In some examples, the mounting element and the implant alignment device define a longitudinal axis and the one or more rails and the one or more slots extend in a direction that is parallel to the longitudinal axis.

[0013] In some examples, the one or more rails and one or more slots are configured to prevent circumferential movement of the implant alignment device relative to the alignment guide.

[0014] In some examples, an internal surface of the mounting element comprises one or more slots and the coupling portion of the implant alignment device comprises one or more guide elements, wherein the guide elements are configured to slide within the slots. In some examples, the slots comprise a lodging portion, wherein when the guide elements are in the lodging portion, the alignment guide and the implant alignment device are axially fixed relative to one another. In some examples, the slots comprise an axial extending portion, and wherein when the guide elements are in the axially extending portion of the slots the implant alignment device is configured to slide axially relative to the alignment guide.

[0015] In some examples, the prosthetic implant comprises a prosthetic valve. In some examples, the prosthetic implant comprises a stent.

[0016] In some examples, an alignment assembly for crimping a prosthetic implant, comprises: an alignment guide comprising: a mounting portion defining an inner cavity and an outer surface, wherein the outer surface comprises one or more engagement members configured to secure the mounting portion to a crimping device; and a positioning portion coupled to the mounting portion and extending in a proximal direction configured to receive a shaft portion of a distal end portion of a delivery apparatus; and an implant alignment device moveably coupled to the mounting portion of the alignment guide and comprising a support portion and a coupling portion, wherein the support portion is configured to support a prosthetic implant on a distal end portion and extend at least partially within a central channel of the crimping device, and wherein the coupling portion is configured to extend at least partially within the inner cavity of the mounting portion such that the implant alignment device and the mounting portion are slidable relative to one another.Attorney Docket No: THVMC-23892WO01

[0017] In some examples, the positioning portion is configured to retain the shaft portion of the distal end portion of a delivery apparatus such that a target crimping location of the delivery apparatus extends into the central channel of the crimping device.

[0018] In some examples, the implant alignment device is configured to position the prosthetic implant around the target crimping location within the central channel of the crimping device.

[0019] In some examples, the implant alignment device further comprises a coupling member positioned on an outer diameter of the implant alignment device which is configured to fit within a slot in the crimping device, wherein crimping the prosthetic implant results in the coupling member sliding out of and detaching from the crimping device.

[0020] In some examples, the mounting portion of the alignment guide further comprises a proximal wall which comprises one or more apertures and the coupling portion of the implant alignment device further comprises one or more protrusions, wherein the apertures are configured to allow the protrusions to pass through as the implant alignment device slides in the proximal direction relative to the alignment guide.

[0021] In some examples, the inner cavity of the mounting portion comprises one or more slots and the coupling portion of the implant alignment device comprises one or more guide elements, wherein the guide elements are configured to slide within the slots. In some examples, the slots comprise a lodging portion, wherein when the guide elements are in the lodging portion, the alignment guide and the implant alignment device are axially fixed relative to one another. In some examples, the slots comprise an axial extending portion, and wherein when the guide elements are in the axially extending portion of the slots the implant alignment device is configured to slide axially relative to the alignment guide.

[0022] In some examples, an assembly for crimping a prosthetic implant on a delivery apparatus comprises: a crimping device comprising a central channel, a first side portion, and a second side portion, wherein the central channel extends from the first side portion to the second side portion; an alignment guide coupled to the first side portion of the crimping device and configured to receive a distal end portion of a delivery apparatus and position a target crimping location of the distal end portion of the delivery apparatus within the central channel of the crimping device; and an implant alignment device slidably coupled to the alignment guide, andAttorney Docket No; THVMC-23892WO01 configured to position a prosthetic implant around the target crimping location of the distal end portion of the delivery apparatus and within the central channel of the crimping device.

[0023] In some examples, the alignment guide comprises a positioning portion extending in a proximal direction from the first side portion of the crimping device and configured to receive a shaft portion of the distal end portion of a delivery apparatus.

[0024] In some examples, the positioning portion of the alignment guide further comprises one or more retention members configured to retain the shaft portion of the distal end portion of the delivery apparatus and prevent axial and radial movement relative to the alignment guide.

[0025] In some examples, the alignment guide comprises a mounting portion coupled to a distal end of the positioning portion and having an inner diameter defining an inner cavity and an outer surface wherein the outer surface comprises one or more engagement members configured to couple with a crimping device; and the implant alignment device is sized and shaped to fit at least partially within the inner diameter of the mounting portion such that the implant alignment device and the mounting portion are slidable relative to one another, and wherein the implant alignment device is configured to extend at least partially within a central channel of the crimping device.

[0026] In some examples, the implant alignment device has a coupling member positioned on an outer diameter of the implant alignment device which is sized and shaped to fit within a slot in the crimping device, wherein crimping the prosthetic implant results in the coupling member sliding out of and detaching from the crimping device.

[0027] In some examples, an alignment guide for a delivery apparatus comprises: a positioning portion configured to receive a shaft portion of a distal end portion of a delivery apparatus for a prosthetic implant and to position a target crimping location of a distal end portion of a delivery apparatus within a central channel of a crimping device; and a mounting portion coupled to a distal end portion of the positioning portion comprising an inner cavity, an outer surface, and one or more engagement members coupled to the outer surface and disposed radially outward from the inner cavity, and configured to releasably secure the alignment guide to a first side portion of a crimping device.

[0028] In some examples, the positioning portion comprises one or more jaws, configured to prevent movement of the delivery apparatus relative to the crimping device. In some examples,Attorney Docket No; THVMC-23892WO01 the positioning portion is configured to restrict circumferential movement of the delivery apparatus relative to the crimping device. In some examples, the positioning portion is configured to restrict axial movement of the delivery apparatus relative to the crimping device. In some examples, the alignment guide further comprising a locking mechanism configured to lock the one or more jaws in a closed position.

[0029] In some examples, the positioning portion and the mounting portion comprise two separate pieces which are releasably coupled to one another.

[0030] In some examples, an assembly for crimping a prosthetic implant on a delivery apparatus comprises: a crimping device; an alignment guide coupled to the first side portion of the crimping device; and an implant alignment device disposed within the inner cavity of the mounting portion of the alignment guide and coupled to the first side portion of the crimping device.

[0031] In some examples, the implant alignment device comprises: a coupling portion configured to fit at least partially within the inner cavity of the mounting portion such that the implant alignment device and the mounting portion are slidable relative to one another, and wherein the implant alignment device is configured to extend at least partially within a central channel of the crimping device; a support portion coupled to the coupling portion, the support portion tapers from a wider end that is disposed adjacent to the coupling portion to a narrower end portion, wherein the support portion comprises an outward facing support surface that is configured to receive a prosthetic implant thereon; and a central channel defining a longitudinal axis and extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus therethrough.

[0032] In some examples, the coupling portion comprises a coupling member, wherein the coupling member is positioned radially outward from the support portion and sized and shaped to within a slot in the crimping device.

[0033] In some examples, the assembly further comprises one or more one or more axially extending alignment members, each alignment member extends axially from the wider end of the support portion, wherein the one or more axially extending alignment members extend over the narrower end portion of the support portion, each alignment member comprising a free end configured to abut an end of the prosthetic implant.Attomey Docket No: THVMC-23892WO01

[0034] In some examples, a method of mounting a prosthetic implant to a delivery apparatus comprises: positioning a prosthetic implant onto an implant alignment device; coupling a prosthetic implant delivery apparatus to an alignment guide; loading the implant alignment device within the alignment guide; positioning a distal end portion of the prosthetic implant delivery apparatus, the prosthetic implant, and a distal end portion of the implant alignment device within a central channel of a crimping device.

[0035] In some examples, loading the implant alignment device within the alignment guide comprises positioning the implant alignment device in a lodging position such that the implant alignment device is axially fixed relative to the alignment guide.

[0036] In some examples, the method further comprises placing the implant alignment guide in an actuation position by rotating the alignment guide relative to the implant alignment device resulting in the implant alignment device being free to move axially relative to the alignment guide.

[0037] In some examples, the method further comprises crimping the prosthetic implant, resulting in a crimped prosthetic implant. In some examples, crimping the prosthetic implant results in the implant alignment device moving axially relative to the alignment guide.

[0038] In some examples, a method of mounting a prosthetic implant to a delivery apparatus comprises: positioning a prosthetic implant onto an implant alignment device; positioning a distal end portion of a prosthetic implant delivery apparatus within a support portion of an alignment guide; inserting a proximal portion of the implant alignment device within an inner cavity of a mounting portion of the alignment guide which results in a balloon catheter of the prosthetic implant delivery apparatus being positioned within a central channel of the implant alignment device and within a central passage of the prosthetic implant; and positioning the balloon catheter, the prosthetic implant, and a distal end portion of the implant alignment device within a central channel of a crimping device and coupling the implant alignment device and the mounting portion of the alignment guide to a proximal side portion of the crimping device, such that the prosthetic implant is axially aligned with compression elements of the crimping device.

[0039] In some examples, a method of mounting a prosthetic implant to a delivery apparatus comprises: positioning a prosthetic implant onto an implant alignment device, wherein a proximal end portion of the implant alignment device is positioned within a mounting portionAttorney Docket No; THVMC-23892WO01 which comprises an inner cavity and an outer surface, wherein the outer surface comprises one or more engagement members configured to couple the mounting portion to a crimping device; positioning the prosthetic implant and a distal end portion of the implant alignment device within a central channel of a crimping device; coupling the mounting portion to a proximal side portion of the crimping device, such that the prosthetic implant is axially aligned with compression elements of the crimping device; positioning a distal end portion of a prosthetic implant delivery apparatus within a positioning portion of an alignment guide; inserting a balloon catheter of the prosthetic implant delivery apparatus within a central channel of the implant alignment device, a central passage of the prosthetic implant, such that a target crimping location of the balloon catheter is axially aligned with compression elements of the crimping device; coupling a distal end portion of the positioning portion of the alignment guide to a proximal end portion of the implant alignment device.

[0040] In some examples, the method further comprises, prior to inserting a balloon catheter of the prosthetic implant delivery apparatus within a central channel of the implant alignment device, removing a spacer which is configured to maintain the implant alignment device at a desired position within the inner cavity of the mounting portion.

[0041] In some examples, the method further comprises crimping the prosthetic implant, resulting in a crimped prosthetic implant.

[0042] In some examples, crimping the prosthetic implant comprises one or more crimping motions, wherein each of the crimping motions has the result of ensuring the prosthetic implant is properly crimped.

[0043] In some examples, crimping the prosthetic implant results in the implant alignment device moving axially within the inner cavity of the mounting portion and being ejected from the crimping device.

[0044] In some examples, the implant alignment device is retained within the inner cavity of the mounting portion.

[0045] In some examples, the prosthetic implant comprises one or more commissures and positioning the prosthetic implant onto the implant alignment device comprises aligning the one or more commissures with one or more markings one the implant alignment device.Attorney Docket No: THVMC-23892WO01

[0046] In some examples, the method comprises removing the balloon catheter and the crimped prosthetic implant, which is now disposed on the balloon catheter, from the alignment guide, crimping device, and implant alignment device.

[0047] In some examples, the method comprises inserting the delivery apparatus into a subject’s (e.g., a living subject, a simulation, etc.) vasculature.

[0048] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with body parts, heart, tissue, etc. being simulated).

[0049] 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, which proceeds with reference to the accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0050] FIGS. 1A-1B are perspective views illustrating components of a prosthetic implant preparation assemblies according to one example.

[0051] FIGS. 2A-2B are detailed perspective views of a distal end portion of a delivery apparatus.

[0052] FIGS. 3A-3C are perspective views of components of an alignment guide according to one example.

[0053] FIG. 4 is a perspective view of an implant alignment device configured to interface with the alignment guide of FIGS. 3A-3C.

[0054] FIG. 5 is a perspective view of an implant alignment device according to another example.

[0055] FIG. 6 is a perspective view of an alignment guide, configured to interface with the implant alignment device of FIG. 5, according to another example.Attorney Docket No: THVMC-23892WO01

[0056] FIG. 7 is a perspective view of the alignment guide of FIG. 6 with the upper jaw and locking mechanism installed.

[0057] FIGS. 8A-8C are cross sectional views of the implant alignment device of FIG. 5 and the alignment guide of FIG. 6 in operation.

[0058] FIGS. 9A-9B are perspective views of an implant alignment device according to a third example.

[0059] FIG. 10 is a perspective view of a mounting portion of an alignment guide according to a third example.

[0060] FIG. 11 is a perspective view of a positioning portion of an alignment guide configured to interface with the mounting portion of FIG. 10.

[0061] FIG. 12 is an exploded, perspective view of the implant alignment device, mounting portion of the alignment guide, and positioning portion of the alignment guide according to the same examples as in FIGS 9A-11.

[0062] FIG. 13 depicts an example of a prosthetic heart valve that can be implanted using any of the delivery apparatuses disclosed herein.DETAILED DESCRIPTIONGeneral Considerations

[0063] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0064] 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 specificAttorney Docket No: THVMC-23892WO01 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 having the benefit of this disclosure.

[0065] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps not expressly referenced. Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language. It is further noted that the claims can be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation.

[0066] 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 unless otherwise specified herein. 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 unless otherwise specified herein. Thus, for example and where applicable, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the subject’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the subject’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.Attorney Docket No: THVMC-23892WO01

[0067] As used herein, the term “operatively coupled,” as used to describe a configuration and / or relationship between two or more components, is intended to refer to a configuration and / or relationship in which the components are directly or indirectly coupled to one another in a manner consistent with the structures and / or functions disclosed herein. For example, a pair of components may be described as being operatively coupled to one another when such components are coupled to one another in a manner that is operative to produce the structural configurations and / or functional properties disclosed herein.

[0068] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.”Introduction to the Disclosed Technology

[0069] Disclosed herein are various systems, apparatuses, methods, etc., including prosthetic implant preparation assemblies that can be used in conjunction with implantable medical devices, for example prosthetic implants (such as transcatheter heart valves (THV) and / or stents). The various systems, apparatuses, methods, etc. disclosed herein generally are directed to preparing the implantable prosthetic implants for delivery through a subject’s vasculature to a target implantation site. In particular, the present disclosure pertains to examples in which the implantable prosthetic implant comprises an annular frame that can be crimped to a constricted diameter for passage through the subject’s vasculature and subsequently expanded to an operative diameter by an inflatable balloon of the delivery apparatus.

[0070] Before crimping, a balloon-expandable implantable prosthetic implant can be placed over an expandable balloon on a catheter shaft. In cases where the implant was manufactured in its fully crimped diameter, the implant is expanded and then crimped on the balloon. In order to ensure that the balloon reliably expands the frame of the implant after the implant reaches a target implantation site in the subject’s vasculature, it may be beneficial to ensure that the crimping process results in the implant being crimped accurately onto the balloon at a repeatably precise location. The proper placement of the crimped prosthetic implant on the target crimping location can help to ensure a predictable deployment. An accurate and precise crimp at the target crimping location of the balloon helps to ensure repeatable and reliable implant expansion and deployment shape of the frame. It also may be beneficial to ensure that the crimping process crimps the frame of the implant evenly and without damage to the implant while ensuring that the crimped diameter of the implant is sufficiently small to traverse the subject’s vasculature.Attorney Docket No: THVMC-23892WO01The present disclosure provides one or more advantages, including addressing one or more of these needs.

[0071] The present disclosure generally is directed to examples of implantable valve preparations assemblies and to examples of methods of utilizing various components of prosthetic valve preparation assemblies to prepare an implantable prosthetic valve for delivery to a target implantation site.

[0072] As shown in FIGS. 1A-1B, and as discussed in more detail below, a prosthetic implant preparation assembly 10 can comprise a prosthetic valve 300, a delivery apparatus 200 configured to deliver a prosthetic implant, such as prosthetic valve 300, to the target implantation site, and a crimping device 100 for crimping the prosthetic valve 300 around the delivery apparatus 200.Exemplary Implantable Prosthetic Valve

[0073] Various prosthetic implants are described and / or discussed herein. While specific examples of prosthetic heart valves are discussed herein, general structures, methods of manufacture, and methods of use of various implantable prosthetic implants that can be adapted for use with the apparatuses and methods disclosed herein are described in at least U.S. Pat. No. 9,393,110, U.S. Pat. No. 10,195,025, U.S. Pat. No. 11,013,600, and U.S. Pat. No. 11,185,406, the disclosures of which are incorporated by reference herein in their entirety.

[0074] FIGS. 1A illustrates an example of a prosthetic implant, in the depicted example, the prosthetic implant is as prosthetic valve 300. As used herein, the implantable prosthetic implant is an implantable prosthetic valve 300 (also may referred to as a “prosthetic valve” and / or a “transcatheter heart valve (THV)”).Examples of a Delivery Apparatus

[0075] Prosthetic implant delivery apparatus according to examples, and / or components thereof, are shown in FIGS. 1A and 2A-2B. While specific examples of delivery apparatus are discussed herein, general structures and methods of use of various prosthetic implant delivery apparatus that can be adapted for use with the apparatuses and methods disclosed here are described in at least U.S. Pat. No. 9,061,119 and U.S. Pat. No. 9,339,384, the disclosures of which are incorporated by reference herein in their entirety.Attorney Docket No: THVMC-23892WO01

[0076] As illustrated in FIGS. 1A and 2A-2B, a delivery apparatus 200 can comprise a steerable guide catheter 210 and a balloon catheter 220 extending through the guide catheter 210. As used herein, the guide catheter 210 (also may be referred to as a “flex catheter” and / or a “main catheter”). The use of the term “guide catheter” should be understood, however, to include flex or main catheters, as well as other catheters that do not have the ability to flex or guide through a subject’s vasculature. In some examples, such as in the illustrated example, the guide catheter 210 and the balloon catheter 220 are adapted to slide longitudinally relative to each other to facilitate delivery and positioning of the implantable prosthetic valve 300 at the target implantation site in the subject's body.

[0077] As shown in FIG. 1A, the guide catheter 210 includes a handle portion 212 and an elongate guide catheter shaft, or tube, 214 extending from the handle portion 212. The balloon catheter 220 includes a proximal portion 222 adjacent to the handle portion 212 and a balloon catheter shaft 226 that extends from the proximal portion 222 and through the handle portion 212 and the guide catheter shaft 214. The delivery apparatus 200 additionally comprises an inflatable balloon 230 mounted on the balloon catheter 220 at a distal portion 224 of the balloon catheter 220, which is opposite the proximal portion 222.

[0078] The inflatable balloon comprises a target crimping location around which the implantable prosthetic implant, such as prosthetic valve 300 is crimped. One example of a target crimping location 232 is shown in FIGS. 2A-2B. As discussed in more detail herein, the delivery apparatus 200 generally is configured such that the implantable prosthetic valve 300 is mounted to the delivery apparatus 200 in a crimped state to prepare the delivery apparatus 200 and the implantable prosthetic valve 300 for insertion into a subject’s vasculature. The term “target crimping location” is intended to refer to any suitable axial location and / or range of locations along the inflatable balloon 230 at which the implantable prosthetic valve 300 is to be operatively coupled. As an example, the target crimping location may include and / or be an axial position along the inflatable balloon 230 at which a distal end of the implantable prosthetic valve 300 is to be located when the implantable prosthetic valve 300 is properly crimped to the inflatable balloon 230.

[0079] In some examples, the target crimping location may include and / or be an axial position along the inflatable balloon 230 at which a proximal end of the implantable prosthetic valve 300Attorney Docket No: THVMC-23892WO01 is to be located when then implantable prosthetic valve 300 is properly crimped to the inflatable balloon 230.

[0080] In some examples, the target crimping location may refer to a portion (e.g., an interval) of the length of the inflatable balloon 230 within which the implantable prosthetic valve 300 is to be positioned when the implantable prosthetic valve 300 is properly crimped to the inflatable balloon 230.

[0081] In some examples, the target crimping location may refer to a position proximal relative to the position of the prosthetic valve 300 shown in FIG. 2B. For example, a prosthetic valve can be crimped onto a proximal portion of the inflatable balloon or onto a location proximal to the balloon. In such instances, after the delivery apparatus and the prosthetic valve are inserted into the subject’s vasculature, the prosthetic valve can be moved distally from the crimped location to a position on the inflatable balloon configured for deploying the prosthetic valve.

[0082] In some examples, as illustrated in FIGS. 2A-B, the delivery apparatus 200 may comprise a stylet 250 which can comprise a cylindrical stylet shaft 252 (e.g., a rigid and / or metallic shaft).Examples of a Crimper Assembly

[0083] As discussed herein, the prosthetic implant preparation assembly 10 generally comprises a crimping device 100 for crimping the implantable prosthetic valve 300 onto the inflatable balloon 230. Crimper assemblies according to some examples, and / or components thereof, are shown in FIGS. 1A-1B. While specific examples of crimper assemblies are discussed herein, general structures and methods of use of various crimper assemblies that can be adapted for use with the apparatuses and methods disclosed here are described in at least U.S. Pat. No. 7,530,253, the disclosure of which is incorporated by reference herein in its entirety.

[0084] As illustrated at least in FIGS. 1A-1B, a crimping device 100 can comprise a base 112, a housing 110 fixedly mounted to the base 112, and a plurality of compression elements. In the depicted example the plurality of compression elements comprises a plurality of circumferentially arrayed nesting jaws 114 supported within the housing 110. More specifically, the housing 110 defines a crimper assembly central axis 101, and the jaws 114 are radially moveable within the housing 110 toward and away from the crimper assembly central axis 101. The jaws 1 14 collectively define a crimper aperture 130 (also referred to as a “central channel”)Attorney Docket No: THVMC-23892WO01 that varies in diameter as the jaws 114 move toward and away from the crimper assembly central axis 101.

[0085] The crimping device 100 further comprises an actuator handle 120 configured to be manually actuated to move the jaws 114 to vary the diameter of the crimper aperture 130. Specifically, in the illustrated example, the actuator handle 120 can be pivoted relative to the housing 110 in a first direction to move the jaws 114 radially toward the crimper assembly central axis 101, and the actuator handle 120 can be pivoted relative to the housing 110 in a second direction that is opposite the first direction to move the jaws 114 radially away from the crimper assembly central axis 101. Accordingly, when the implantable prosthetic valve 300 is positioned within the crimper aperture 130, actuating the actuator handle 120 to decrease the diameter of the crimper aperture 130 can operate to crimp the implantable prosthetic valve 300.

[0086] The crimping device 100 may comprise a distal side portion 102 (also referred to as a “distal face”) and a proximal side portion 104 (also referred to as a “proximal face”) and the crimper aperture 130 may extend from an opening on the distal side portion 102 to an opening on the proximal side portion 104. With respect to the crimping devices disclosed herein, the term “proximal side portion” refers to a first side of the crimping device, for example, the side of the crimping device through which the distal end of the delivery apparatus is initially inserted, and the term “distal side portion” refers to the side of the crimping device that is opposite to the proximal side of the crimping device. In some instances, the proximal side portion of the crimping device can be referred to as “a first side portion” and the distal side portion of the crimping device can be referred to as “a second side portion.”

[0087] The distal side portion 102 and / or the proximal side portion 104 may comprise one or more coupling mechanisms. In some examples, as illustrated in FIG. 1A, the distal side portion 102 may comprise a cut-out portion 108 (also referred to as a “recess”). In some examples, as illustrated in FIG. IB, the proximal side portion 104 may comprise one or more slots 106. In the depicted example, there are three slots 106 which are configured to couple with a corresponding mechanism which may be turned, such as in a clockwise direction to secure to the crimping device 100.

[0088] In some examples, the proximal side portion 104 may comprise a cut-out portion 116.Attorney Docket No: THVMC-23892WO01

[0089] In some examples, the distal side portion 102 and / or the proximal side portion 104 may comprise other coupling mechanisms such as a recess, snap-in feature, alternate alignment feature, or a combination of any of these that is configured to mate with a corresponding mating interface on a component such as an implant alignment device or an alignment guide, as described in detail below.

[0090] In some examples, the crimper aperture 130 extends along a crimper aperture length, as measured along a direction parallel to the crimper assembly central axis 101, that is equal to or greater than a length of the implantable prosthetic valve 300. Accordingly, in such examples, the implantable prosthetic valve 300 may be positioned fully within the crimper aperture 130 such that the crimping device 100 exerts a crimping force evenly across the full length of the implantable prosthetic valve 300.

[0091] When the crimping device 100 is utilized to fully crimp the implantable prosthetic valve 300 to the delivery configuration, the implantable prosthetic valve 300 can engage the inflatable balloon 230 sufficiently tightly that the implantable prosthetic valve 300 is restricted from translating relative to the inflatable balloon 230. Thus, prior to fully crimping the implantable prosthetic valve 300 upon the inflatable balloon 230, it is desirable to ensure that the implantable prosthetic valve 300 is properly positioned at the target crimping location.

[0092] In some examples, it may be desirable to partially crimp the implantable prosthetic valve 300 to an intermediate configuration prior to fully crimping the implantable prosthetic valve 300 to the delivery configuration. Specifically, in such examples, the implantable prosthetic valve 300 in the intermediate configuration may be sized (e.g., in inner diameter) to engage the delivery apparatus 200 and / or the inflatable balloon 230 such that the implantable prosthetic valve 300 may be manually translated relative to the inflatable balloon 230, but such that the implantable prosthetic valve 300 is at least partially restricted from inadvertent translation relative to the inflatable balloon 230. In this manner, crimping the implantable prosthetic valve 300 to the intermediate configuration and subsequently positioning the implantable prosthetic valve 300 at the target crimping location may ensure that the implantable prosthetic valve 300 remains at the target crimping location during the final crimping action.

[0093] 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 theAttorney Docket No: THVMC-23892WO01 crimper aperture 130 to a corresponding predetermined diameter. This in turn can be accomplished by mechanically limiting a range of motion of the actuator handle 120 during use of the crimping device 100.

[0094] More specifically, as illustrated in FIGS. 1A-1B the crimping device 100 can comprise a first crimp stop 150 and a second crimp stop 170, each of which may be utilized to define a respective range of motion of the actuator handle 120. The second crimp stop 170 can be fixedly coupled relative to the housing 110 during use of the crimping device 100, and the first crimp stop 150 can be selectively and operatively coupled to the second crimp stop 170. In particular, and as described in more detail herein, the first crimp stop 150 is configured to be mechanically coupled to the second crimp stop 170.

[0095] In some examples, the first crimp stop 150 and the second crimp stop 170 may be described as representing components of a crimp stop assembly 140 of the crimping device 100. In particular, FIG. 1A illustrates an example of a crimp stop assembly 140 that includes a first example of the first crimp stop 150 in combination with the second crimp stop 170.

[0096] When the first crimp stop 150 is operatively coupled to the second crimp stop 170, the first crimp stop 150 and the second crimp stop 170 collectively can define a partial range of motion of the actuator handle 120. That is, when the first crimp stop 150 is operatively coupled to the second crimp stop 170, the actuator handle 120 may be actuated to decrease the diameter of the crimper aperture 130 only until the actuator handle 120 engages the first crimp stop 150, at which point the actuator handle 120 is mechanically restricted and / or prevented from further actuation in this direction. Crimping in this manner can correspond to a partially crimped state.

[0097] With the first crimp stop 150 removed, the actuator handle 120 may be actuated to decrease the diameter of the crimper aperture 130 only until the actuator handle 120 engages the second crimp stop 170, at which point the actuator handle 120 is mechanically restricted and / or prevented from further actuation in this direction. Crimping in this manner can correspond to a fully crimped state.

[0098] While specific examples of crimper assemblies and crimp stop assemblies are discussed herein, general structures and methods of use of crimper assemblies and various crimp stop assemblies that can be adapted for use with the apparatuses and methods disclosed here areAttorney Docket No: THVMC-23892WO01 described, for example, in International Pub. No. WO 2024 / 015433 Al, which is incorporated by reference herein in its entirety.

[0099] In some examples of delivery assemblies for transporting implantable prosthetic implants, the delivery apparatus is configured such that the implantable prosthetic implant is crimped onto a location that is proximal to, but removed from, the inflatable balloon. Such configurations may facilitate crimping the prosthetic implant to relatively small profile, thereby facilitating delivery of the prosthetic valve through the subject’s vasculature. The use of such systems generally necessitates a separate step of repositioning the prosthetic implant upon the inflatable balloon while inside the subject’s vasculature.

[0100] By contrast, mounting the prosthetic implant directly onto the inflatable balloon prior to entering the subject’s vasculature can improve the reliability and ease of implanting the prosthetic valve at the target implantation site. Accordingly, the apparatuses and methods disclosed herein can be used to crimp a prosthetic implant such as the implantable prosthetic valve 300 on the inflatable balloon 230 with a tightly compressed profile and at a precise target crimping location relative to the delivery apparatus 200. Manually aligning and mounting the prosthetic implant directly onto the inflatable balloon can present challenges and may require extensive training for users. It is desirable to increase automation in the valve crimping process, which in turn can increase accuracy and uniformity of the positioning of the crimped prosthetic implants while reducing the amount of training required for users to proficiently place the prosthetic implants. The proper placement of the crimped prosthetic implant at the target crimping location on the balloon can help to ensure a predictable deployment. An accurate and precise crimp at the target crimping location helps to ensure repeatable and reliable implant expansion and deployment shape of the frame. The crimping tools described herein can help to ensure repeatability and reliability.

[0101] Additional components may be used to increase automation and provide the benefits described above.

[0102] In some examples, an alignment assembly for crimping a prosthetic implant on a target crimping location relative to a delivery apparatus comprises an implant alignment device, such as any of implant alignment device 500, 600, 800, and an alignment guide, such as any of alignment guide 400, 700, 900.Attorney Docket No: THVMC-23892WO01

[0103] In some examples, the assembly is used with a crimping device, such as crimping device 100.

[0104] In some examples, the assembly comprises the alignment guide 400. depicted in FIGS. 3A-3C and the implant alignment device 500, depicted in FIG. 4.

[0105] In some examples, the assembly comprises the alignment guide 700, depicted in FIGS. 6-7, and the implant alignment device 600, depicted in FIG. 5.

[0106] In some examples, the assembly comprises the alignment guide 900, depicted in FIGS. 10-12, and the implant alignment device 800, depicted in FIGS. 9A-9B.

[0107] While specific examples of implant alignment devices and alignment guides are discussed herein, general structures and methods of use of various implant alignment devices and / or alignment guides that can be adapted to be usable and / or for use with the apparatuses and methods disclosed here are described in at least in U.S. Pub. No. 2023 / 0218415 and International Pub. No. WO 2022 / 046585, which are incorporated by reference herein in their entirety.

[0108] FIGS. 3A-3C depict components of an exemplary alignment guide 400 which may be used as a part of an alignment assembly for crimping a prosthetic implant to position a distal end portion of a prosthetic implant delivery apparatus 200 at a preselected position within a crimping device 100. The alignment guide 400 can comprise one or more retention members configured to retain the shaft portion of the distal end portion of the delivery apparatus and prevent axial and radial movement relative to the alignment guide.

[0109] In some examples, the alignment guide 400 may comprise a positioning portion 402 (also referred to as a “positioning element”) and a mounting portion 404 (also referred to as a “mounting element”) along with an upper jaw 406 (see FIG. 3B), and a removable locking mechanism 450 (see FIG. 3C).

[0110] In some examples, the alignment guide 400 comprises the positioning portion 402 and the mounting portion 404 formed (e.g., molded together) as one piece (i.e. as a unitary component). The positioning portion 402 can define a central channel 410 which can be sized and shaped to receive the guide catheter shaft 214 and help ensure it stays at the desired axial position within the central channel 410.Attorney Docket No: THVMC-23892WO01

[0111] In some examples the positioning portion 402 and the mounting portion 404 may comprise two separate pieces. The positioning portion 402, upper jaw 406. and locking mechanism 450 may have features which are configured to engage a distal end portion of the delivery apparatus and restrict axial and / or circumferential movement of the delivery apparatus relative to the alignment guide. In the depicted example, the upper jaw 406 comprises an opening 409 configured to interact with the hinge 408.

[0112] In some examples, the opening may be sized and shaped to have, for example, a friction fit and / or a snap fit with the hinge 408. In some examples, there may be one or more jaws.

[0113] In some examples, the locking mechanism 450 is configured to lock the upper jaw 406 in a closed position.

[0114] In some examples, positioning the prosthetic implant delivery apparatus at a preselected position ensures that the prosthetic implant is crimped at the target crimping location. This may have the benefit of increasing accuracy and increasing uniformity in the prosthetic implant crimping location on the delivery apparatus. The locking mechanism 450 can be used to lock the positioning portion 402 to the upper jaw 406 and help to ensure the guide catheter shaft 214 stays at the desired axial position within the central channel 410. In the depicted example, the locking mechanism 450 defines an opening 452 that is sized and shaped to fit over a rail 403 of the positioning portion and an edge 407 of the upper jaw 406.

[0115] In some examples, the edge 407 is slightly flared outward and the opening 452 is shaped and sized to slide over edge 407 and the slight flare of edge 407 retains the locking mechanism 450 in place via, for example, a snap fit and / or a friction fit. The upper jaw 406 and the locking mechanism 450 can be installed on the positioning portion 402 in a manner similar to that depicted in FIG. 7 for alignment guide 700.

[0116] The alignment guide 400 is clamped around the guide shaft 214 at a location proximal to and near and / or adjacent to a proximal end portion of the balloon 230. Thus, the positioning portion 402, and upper jaw 406 have the advantage of keeping the target crimping location at the desired axial and radial position within the crimping device 100.

[0117] The mounting portion 404 can be disposed at a distal end of the alignment guide 400.The mounting portion 404 may have features which are configured to couple the alignment guideAttorney Docket No: THVMC-23892WO01400 to a crimping device, for example to the proximal side portion 104 of the crimping device 100.

[0118] In some examples, the mounting portion 404 can include one or more engagement members that are configured to mate with corresponding mating features on a side surface (e.g., proximal face) of a crimping device, such as the crimping device 100.

[0119] In some examples, the mounting portion 404 comprises a wall 413 which forms a cylindrical, or a partial cylindrical shape, and is sized and shaped to couple with a portion (e.g.. the proximal side portion 104) of the crimping device 100.

[0120] In some examples, the mounting portion 404 comprises one or more engagement members which are coupled to the outer surface of the mounting portion and which are sized and shaped to fit with corresponding features of the crimping device 100.

[0121] In some examples, as shown in FIG. 3A, the engagement members are configured as tabs or fingers extending in the axial direction.

[0122] In some examples, the engagement members may comprise one or more fingers which can be spaced apart from one another around a circumference of the mounting portion 404. In the depicted example, the engagement members comprise three fingers 414, circumferentially spaced from one another. Each finger 414 comprises a free end 416 and attached end 418 that are formed by one or more slots 420 in (through) the cylindrical wall. The free end 416 may include a protrusion 422 (or nub or bump) that protrudes radially outward from an outer surface of the free end 416 and is configured to couple with corresponding features on a portion (e.g.. the proximal side portion 104) of the crimping device 100, such as one or more slots 106.

[0123] In some examples, the mounting portion 404 can have different configurations, such as a recess, snap-in feature, or alternate alignment features that are configured to mate with a corresponding mating interface of the crimping device 100. As one example, the mounting portion 404 may comprise one or recesses and a portion (e.g., the proximal side portion 104) of the crimping device may comprise a corresponding one or more fingers.

[0124] In some examples, the mounting portion 404 can further include one or more indicating elements that can indicate an orientation of insertion into the crimping device, such as arrows, triangles, dots, etc.Attorney Docket No: THVMC-23892WO01

[0125] In some examples, the mounting portion 404 has one or more features which are configured to interface with an implant alignment device. In the depicted example, the mounting portion 404 defines an inner cavity 424 which is sized and shaped to receive an implant alignment device and / or a portion thereof. In the depicted example, the inner cavity 424 is configured to receive the coupling portion 502 of the implant alignment device 500.

[0126] In some examples, the mounting portion 404 may comprise one or more ledges 426, which extend radially inward into the inner cavity 424 and are configured to support corresponding features on an implant alignment device, such as edge 521 of the implant alignment device 500 shown in FIG. 4.

[0127] In some examples, a proximal wall 428 of the mounting portion 404 comprises one or more apertures 430 which are sized and shaped to allow corresponding protrusions 520 of the implant alignment device 500 to pass through as the implant is crimped and the implant alignment device 500 is ejected from the crimping device 100 in the proximal direction.

[0128] Alternate examples of mounting assemblies that are configured to crimp a prosthetic valve onto a delivery apparatus at a predetermined position and / or orientation relative to the delivery apparatus are described in U.S. Pub. No. 2021 / 0030533, which is incorporated by reference herein.

[0129] In some examples, the alignment assembly may also comprise an implant alignment device which may be used to position a prosthetic implant, such as the prosthetic valve 300, at a preselected position within a crimping device, such as within the crimper aperture 130 of the crimping device 100.

[0130] In some examples, the implant alignment device may have features which allow it to maintain the implant position before the crimping device is engaged and then to be ejected as the plurality of circumferentially arrayed nesting jaws 114 of the crimping device 100 come into contact with and then compress the prosthetic implant.

[0131] In some examples, the implant alignment device may comprise a cone shape and / or truncated cone shape which allows the implant alignment device to be ejected in a proximal direction as the implant is moved from an expanded state to a compressed state.Attorney Docket No: THVMC-23892WO01

[0132] FIG. 4 depicts an exemplary implant alignment device 500 that is configured to receive and support a prosthetic implant. The implant alignment device is sized and shaped be partially disposed within an alignment guide, such as alignment guide 400 and, in some examples, is configured to couple to a crimping device, such as crimping device 100. As shown the implant alignment device 500 includes a coupling portion 502 and a support portion 504 (also referred to as an “implant support portion”).

[0133] In some examples, the implant alignment device may further comprise one or more alignment members. The implant alignment device 500 also includes a central channel 508 extending through the coupling portion 502 and the support portion 504. The central channel 508 defines a central axis 501 and is sized and shaped to receive a delivery apparatus for the prosthetic implant therethrough (for example, delivery apparatus 200).

[0134] As mentioned above, and described more fully below, the coupling portion 502 can be configured to fit within the inner cavity 424 defined by mounting portion 404. The coupling portion 502 may also be configured to releasably couple to a crimping device, such as the crimping device 100 shown in FIGS. 1A-1B. The support portion 504 can be configured to support a prosthetic implant (for example, prosthetic valve 300) on an outward facing support surface.

[0135] In some examples, as shown in FIG. 4, the support portion 504 is disposed and / or positioned at and extends distally from the coupling portion 502. In the depicted example, the support portion 504 tapers from a wider end that is disposed and / or positioned at the coupling portion 504 to a narrower end portion. The narrower end can form a support surface 510, which is configured to be inserted into the prosthetic valve 300. In some instances, the support portion 504 and coupling portion 502 can be formed (e.g., molded together) as one piece (as a unitary component).

[0136] The coupling portion 502 includes a first end 512 (proximal end) and a second end 514 (distal end). The coupling portion 502 defines a lumen that forms a portion of a central channel 508. A wall 516, and / or a partial wall, extends between the first end 512 and the second end 514 of the coupling portion 502. The wall 515 can form an annulus, or partial annulus, around the central axis 501.Attorney Docket No: THVMC-23892WO01

[0137] In some examples the wall 516 can have one or more breaks or windows. In the depicted example, the cylindrical wall has three windows 518 (one window is not shown in FIG. 4). The windows 518 can form open portions in the wall 516 such that the wall 516 comprises a partial annular configuration. In the depicted example, the windows 518 are sections that are absent from the wall 516 such that the remaining portions of the wall 516 define an upper portion 519 and protrusions 520. The upper portion 519 and the protrusions 520 can engage the alignment guide 400 as implant alignment device 500 moves relative to the crimping device 100.

[0138] The upper portion 519 comprises lower edges 521. In some examples, the lower edges 521 of the upper portion 519 may correspond to the ledges 426 of the alignment guide 400. The ledges 426 may provide support to the edges 521 as the implant alignment device 500 slides axially relative to the alignment guide 400.

[0139] The protrusions 520 are spaced circumferentially from the upper portion 519 by the windows 518. The protrusions 520 may be sized and shaped to correspond to corresponding features in an alignment guide such as the apertures 430 in the alignment guide 400. In this manner, the protrusions 520 extend through the apertures 430 as the implant alignment device 500 slides axially relative to the alignment guide 400.

[0140] A similar interaction between an implant alignment device and an alignment guide is further described below and depicted in FIGS. 8A-8C.

[0141] In some examples, the coupling portion 502 may include a coupling member 522 that is configured to rotationally align the coupling portion 502 with the crimping device (e.g., crimping device 100, as shown in FIG. 1A-1B). The coupling member 522 can be positioned on an outer diameter of the upper portion 519 of the coupling portion 502, proximate to the first end 512, such that it aligns the coupling portion 502 in a predetermined circumferential orientation within the crimper aperture 130 of the crimping device 100. The coupling member 522 can be configured (shaped) to mate with the cut-out portion 116 of the proximal side portion 104 of the crimping device 100. In this manner, the coupling member 522 rotationally aligns the coupling portion 502, and thus the valve mounted on the support portion 504, with the crimping device 100. As a result of this coupling between the coupling member 522 and cut-out portion 116, the implant alignment device 500, and prosthetic valve mounted thereon, are prevented from rotating during crimping.Attorney Docket No: THVMC-23892WO01

[0142] In some examples, as shown in FIG. 4, the coupling member 522 is an axially extending projection that extends distally from the first end 512 toward the second end 514 of the coupling portion 502. A free end 524 of the coupling member 522 can taper from the top or radially outward facing side to a point.

[0143] In some instances, instead of tapering to a point, the free end 524 can taper to a narrower region (as shown in FIG. 4 and can be referred to as a tapered end).

[0144] In some instances, the free end 524 may taper at both a top (radially outward facing side) and bottom (radially inward facing side) to a point or tapered end. The tapered free end 524 can allow for easier insertion into and coupling with the cut-out portion 116 in the crimping device.

[0145] In some examples, the coupling member 522 can have different configurations, such as a recess, snap-in feature, or alternate alignment feature that is configured to mate with a corresponding mating interface of the crimping device 100. As one example, the crimping device can comprise a projection (in lieu of the cut-out portion 116) and the coupling member can comprise a slot (in lieu of the projection) configured to receive the projection of the crimping device.

[0146] In some examples, using the alignment assembly for crimping a prosthetic implant to a delivery apparatus, comprises positioning a prosthetic valve 300 onto the implant alignment device 500 then positioning a distal portion 224 of the balloon catheter 220 within the central channel 410 of the positioning portion 402 of the alignment guide 400 and is retained in place by the upper jaw 406, which can help to ensure the guide catheter shaft 214 stays at the desired axial position. In some instances, the alignment guide 400 can comprise a mating feature (in lieu of or in addition to the upper jaw 406) that retains the axial position of the balloon catheter 220 relative to the alignment guide 400. The coupling portion 502 of the implant alignment device 500 is inserted into the inner cavity 424 of the mounting portion 404 of the alignment guide 400 which results in a balloon catheter of the prosthetic implant delivery apparatus being positioned within the central channel 508 of the implant alignment device 500 and within a central passage of the prosthetic implant 300. The balloon catheter 220, the prosthetic valve 300, and a distal end portion of the implant alignment device 500 are then positioned within the aperture 130 of a crimping device 100 and the mounting portion 404 of the alignment guide 400 is coupled to theAttorney Docket No: THVMC-23892WO01 proximal side portion 104 of the crimping device 100. In this way, the longitudinal axis 401, the central axis 501, and the crimper assembly central axis 101 are aligned with one another.

[0147] In some examples, where the implant alignment device 500 comprises a coupling member 522, the coupling member 522 is inserted into the cut-out portion 116. The prosthetic implant is axially aligned with compression elements of the crimping device. When the actuator handle 120 of the crimping device 100 is actuated to decrease the diameter of the crimper aperture 130 the implantable prosthetic valve 300 is crimped and the implant alignment device 500 slides axially proximally relative to the crimping device 100 and the alignment guide 400.

[0148] In some examples, as the implant alignment device moves proximally, the protrusions 520 of the implant alignment device 500 pass through the apertures 430 in the proximal wall 428 of the alignment guide 400.

[0149] FIGS. 5-7, depict another example of an alignment assembly for crimping a prosthetic implant on a target crimping location relative to a delivery apparatus. The depicted example includes an implant alignment device 600, depicted in FIG. 5, which is configured to be used with an alignment guide 700, depicted in FIGS. 6-7, such that the implant alignment device 600 is positioned partially within the alignment guide 700 as described in detail below. The implant alignment device 600 shares features with the implant alignment device 500 and that the alignment guide 700 shares features with the alignment guide 400.

[0150] In some examples, the implant alignment device 600 and / or the alignment guide 700 described below are the same as the implant alignment device 500 and / or the alignment guide 400 except for the differences described below. It should be noted, however, that the alignment guides and or implant alignment devices described below need not include all of the components described above.

[0151] In some examples, the implant alignment device 600 includes a coupling portion 602 and a support portion 604 (also referred to as an “implant support portion”). The support portion 604 can include a support surface 610. The implant alignment device 600 also includes a central channel 608 extending through the coupling portion 602 and the support portion 604. The central channel 608 defines a central axis 601 and is sized and shaped to receive a delivery apparatus for the prosthetic implant therethrough (for example, delivery apparatus 200).Attorney Docket No: THVMC-23892WO01

[0152] The coupling portion 602 can be configured to fit within the cavity defined by mounting portion 704 of the alignment guide 700, discussed below. The coupling portion 602 may also be configured to releasably couple to a crimping device, such as the crimping device 100 shown in FIGS. 1A-1B and can include a coupling member 622 that is configured to rotationally align the coupling portion 602 with the crimping device (e.g., crimping device 100).

[0153] The coupling portion 602 includes a first end 612 (proximal end) and a second end 614 (distal end). Components can extend between the first end 612 and the second end 614 of the coupling portion 602.

[0154] In some examples, the coupling portion comprises protrusions, such as protrusions 620 which may be sized and shaped to correspond to corresponding features in an alignment guide such as the apertures 730 in the alignment guide 700.

[0155] In some examples, the protrusions comprise guide elements 624, which are sized and shaped to fit within slots 770 on the inner surface of the mounting portion 704 of the alignment guide 700.

[0156] In some examples, the guide elements are keyed to fit into the slot in a predetermined way. In the depicted example, the guide elements 624 are rectangular projections which are narrower in the axial direction and wider in the circumferential direction.

[0157] In some examples, the coupling portion 602 may comprise slots and the inner surface of the mounting portion 704 may comprise corresponding guide elements.

[0158] In some examples, the support portion 604 may comprise one or more alignment members which can have the advantage of increasing accuracy of the implant placement on the implant alignment device.

[0159] In some examples, the implant alignment device 600 includes one or more axially extending alignment members spaced circumferentially apart from one another around the implant alignment device 600.

[0160] In some examples, the implant alignment device 600 includes three alignment members 606 which are spaced circumferentially apart from one another.Attorney Docket No: THVMC-23892WO01

[0161] In some examples, the implant alignment device 600 can include more or less than three alignment members 606 (e.g., one, two, four, etc.). Each alignment member 606 includes an attached end 648 and a free end 650 disposed axially away from the attached end 648.

[0162] In some examples, the attached end 648 is disposed at (coupled to or formed together with) the second end 614 of the coupling portion 602. Each alignment member extends axially distally from the coupling portion 602, over a portion of the support portion 604 and terminates at a free end 650 adjacent to the support surface 610. In other words, each alignment member 606 extends axially from the wider end of the support portion 604 and extends over a narrower portion of the support portion 604, each alignment member 606 comprising a free end 650 configured to abut an end of the prosthetic implant.

[0163] The support portion 604 can include one or more cut-outs or windows 652 disposed adjacent to each alignment member 606. In some examples, each window 652 can extend from the first end 648 to the support surface 610. In some examples, the support portion 604 can have one window 652 for each alignment member 606 (e.g., three windows 652 in the example shown in FIG. 5). As such, each window 652 can be configured to receive the free end 650 of a respective alignment member 606 therein. For example, the free end 650 of each alignment member 606 is configured to deflect or bend radially inward, into the corresponding window 652, in response to a radially inward directed force applied to its outer surface (e.g., during crimping with the crimping device 100).

[0164] In some examples, the free end 650 of each alignment member 606 is also configured to abut an end of the prosthetic valve and be axially aligned with a commissure of the prosthetic valve, when the prosthetic valve is mounted on the support surface 610.

[0165] In some examples, the free end 650 of each alignment member 606 is configured to be inserted into a prosthetic valve 300 such that the free ends 650 of each alignment member 606 axially overlaps with the proximal end portion of the prosthetic valve 300.

[0166] In some examples, the alignment members 606 can be t-shaped. For example, a cross bar portion 654 of the t-shape can form between the attached end 648 and the free end 650 and a shaft of the t-shape can extend between the free end 650 and the attached end 648.

[0167] In some examples, one or more alignment indicators 662 can be provided. For example, one or more alignment indicators 662 can be disposed on a distal face 664 at the distal end of theAttomey Docket No: THVMC-23892WO01 support portion 604. Each alignment indicator 662 can be axially aligned with a corresponding alignment member 606. As such, each alignment indicator 662 can be configured to indicate an axial location for a commissure of a prosthetic valve when mounted on the support surface 610.

[0168] In some examples, the alignment indicators 662 can be arrows, lines, or variously shaped raised markings protruding from the distal face 664.

[0169] In some examples, the alignment indicators 662 can be arrows, lines, or variously shaped markings in the distal face 664. For example, the alignment indicators 662 can be colored differently than a remainder of the implant alignment device 600. In some examples, the implant alignment device 600 may not include alignment indicators 662.

[0170] FIGS. 6-7 depict an alignment guide 700 which may be used to position a distal end portion of a prosthetic implant delivery apparatus at a preselected position within a crimping device. The alignment device defines a longitudinal axis 701.

[0171] In some examples, the alignment guide 700 may comprise a positioning portion 702 (also referred to as a “positioning element”) and a mounting portion 704 (also referred to as a “mounting element”). The mounting portion 704 may have features which are configured to couple the alignment guide 700 to a crimping device, for example to the proximal side portion 104 of the crimping device 100. The positioning portion 702 may have features which are configured to engage a distal end portion of the delivery apparatus and restrict axial and / or radial movement of the delivery apparatus relative to the alignment guide, the positioning portion 702 should be understood to be substantially the same as the positioning portion 402 described above and should be understood to configured to interface with an upper jaw 706 (similar to upper jaw 406 depicted in FIG. 3B) pivotably coupled via a hinge 708 as well as a locking mechanism 750 (similar to locking mechanism 450 depicted in FIG. 3C).

[0172] In some examples, positioning the prosthetic implant delivery apparatus at a preselected position ensures that the prosthetic implant is crimped at the target crimping location. This may have the benefit of increasing accuracy and increasing uniformity in the prosthetic implant crimping location on the delivery apparatus.

[0173] The mounting portion 704 can include one or more engagement members that are configured to mate with correspondingly shaped mating features on a side surface (e.g., proximal face) of a crimping device, such as the crimping device 100.Attorney Docket No: THVMC-23892WO01

[0174] In some examples, the mounting portion 704 comprises a wall 713 which forms a cylindrical, or a partial cylindrical shape, and is configured to fit the proximal side portion 104 of the crimping device 100.

[0175] In some examples, the mounting portion 704 comprises one or more engagement members which are configured to interface with features on the proximal side portion 104 of the crimping device 100. The engagement members can be disposed radially outward from an inner cavity 724. The mounting portion 704 is configured to releasably secure the alignment guide 700 to a crimping device such as to the proximal side portion 104 of the crimping device 100.

[0176] In some examples, the mounting portion 704 comprises a plurality of arms 712 which extend radially outward from the inner cavity 724 in a spiral arm pattern. The plurality of arms 712 are configured to interface with corresponding the one or more slots 106 on the crimping device 100. In the depicted example, the mounting portion 704 comprises three arms 712. Each arm 712 comprises a free end 714 and attached end 716.

[0177] In some examples, the free end 714 can include a protrusion 720 (or nub or bump) that protrudes radially outward from a radial outer surface of the free end 714.

[0178] In some examples, the mounting portion 704 is configured to be twisted around the longitudinal axis to couple with the crimping device 100, such as by turning the alignment guide 700 a quarter turn. This configuration may have the advantage of ensuring a secure connection between the plurality of arms 712 and the one or more slots 106.

[0179] In some examples, the mounting portion 704 can have different configurations, such as a recess, snap-in feature, or alternate alignment features that are configured to mate with a corresponding mating interface of the crimping device 100. As one example, the mounting portion 704 may comprise one or more recesses and the distal side portion of the crimping device may comprise a corresponding one or more arms.

[0180] In some examples, the mounting portion has one or more features which are configured to interface with an implant alignment device. In the depicted example, the mounting portion 704 defines an inner cavity 724 which is configured to receive an implant alignment device and / or a portion thereof. In the depicted example, the inner cavity 724 is configured to receive the coupling portion 602 of the implant alignment device 600.Attorney Docket No: THVMC-23892WO01

[0181] In some examples, the inner surface of the mounting portion 704 comprises slots 770 which are sized and shaped to correspond to guide elements 624 of the implant alignment device 600. The slots 770 can, for example, restrict and / or enable one or more types of relative movement between the implant alignment device 600 and the alignment guide 700 during different portions of a crimping procedure.

[0182] In some examples, the slots 770 can comprise an insertion portion 772 located on the distal face of the mounting portion 704, a lodging portion 774, a transition portion 776, and an axial extending portion 778. Each of these portions are further described below.

[0183] In some examples, a proximal wall 728 of the mounting portion 704 comprises one or more apertures 730 which are sized and shaped to allow corresponding protrusions 620 of the implant alignment device 600 to pass, at least partially, through the proximal wall 728 as the implant is crimped and the implant alignment device 600 is ejected from the crimping device in the proximal direction.

[0184] As shown in FIG. 7, the alignment guide 700 can comprise one or more retention members configured to retain the shaft portion of the distal end portion of the delivery apparatus and prevent axial and radial movement relative to the alignment guide. In the depicted example, the positioning portion 702 and the upper jaw 706 can be pivotably coupled to one another via a hinge 708. In the depicted example, the upper jaw 706 comprises an opening (similar to opening 409 depicted in FIG. 3B) configured to interact with the hinge 708.

[0185] In some examples, the opening may be sized and shaped to have , for example, a snap fit and / or a friction fit with the hinge 708. The positioning portion 702 and the upper jaw 706 can define a central channel 710 that is configured to receive the guide catheter shaft 214 (or another shaft portion) of the delivery apparatus 200. The central channel 710 defines a longitudinal axis 701 which extends along the positioning portion 702 and through the mounting portion 704.

[0186] FIGS. 8A-8C depict cross-sectional views of the alignment assembly comprising the implant alignment device 600 and the alignment guide 700. These cross-sectional views show the interactions between the implant alignment device 600 and the alignment guide 700 from an initial position to a position where the implant has been crimped on the balloon and the implant alignment device 600 has been ejected from the crimping device and is retained within the mounting portion 704 of the alignment guide 700.Attorney Docket No: THVMC-23892WO01

[0187] FIG. 8A depicts an initial or loading position of the alignment assembly. Prior to this, a distal portion 224 of the balloon catheter 220 can be secured within the positioning portion 702 of the alignment guide 700 and a prosthetic implant, such as prosthetic valve 300, can be positioned on the support portion 604 of the implant alignment device 600. In this depiction, the coupling portion 602 of the implant alignment device 600 is inserted into the inner cavity 724 of the alignment guide 700. During insertion, the guide elements 624 of the implant alignment device 600 pass through the insertion portion 772 of a respective slot 770. The implant alignment device 600 and the alignment guide 700 are turned relative to one another such that each of the guide elements 624 moves to the corresponding lodging portion 774. This results in the balloon catheter 220 being positioned through the central channel 608 of the implant alignment device 600 and such that a target crimping location 232 is axially aligned within the prosthetic implant. With each of the guide elements 624 in the corresponding lodging portion 774, the implant alignment device 600 and the alignment guide 700 are axially locked relative to one another. Axially locking the implant alignment device 600 and the alignment guide 700 together can for example be helpful when installing the implant alignment assembly to the crimping device 100 by restricting relative movement between the implant alignment device 600 and the alignment guide 700 and resulting in greater accuracy and repeatability in the crimping process. The alignment assembly is then inserted into the proximal side portion 104 of the crimping device 100 with the coupling member 622 being inserted into the cut-out portion 116 and the support portion 604 extending into the crimper aperture 130. This results in the prosthetic implant and the target crimping location 232 being axially aligned with jaws 114 within the crimper aperture 130 of the crimping device 100.

[0188] In FIG. 8B, the alignment guide 700 has been moved from the loading position to an actuation position. This is accomplished, for example, by rotating the alignment guide 700 relative to the crimping device 100 (and the implant alignment device 600). This locks the alignment guide 700 into place relative to the crimping device 100 by connecting the plurality of arms 712 of the alignment guide 700 and the one or more slots 106 of the crimping device 100. Since the coupling member 622 of the implant alignment device 600 is inserted into the cut-out portion 116 of the crimping device 100, the implant alignment device 600 remains stationary relative to the crimping device 100 as the alignment guide 700 is rotated relative to the crimping device 100. As the alignment guide 700 is rotated relative to the implant alignment device 600,Attorney Docket No: THVMC-23892WO01 results in the guide elements 624 slide in a circumferential direction through the transition portion 776 of the slots 770. When the rotation of the alignment guide 700 relative to the crimping device 100 is complete, the guide elements 624 are positioned at the distal end of the respective axial extending portions 778. In this position, the implant alignment device 600 is free to slide proximally in the axial direction relative to the alignment guide 700. When the actuator handle 120 of the crimping device 100 is actuated to decrease the diameter of the crimper aperture 130 the implantable prosthetic valve 300 is crimped and the implant alignment device 600 slides axially proximally relative to the crimping device 100 and the alignment guide 700.

[0189] In FIG. 8C, the prosthetic implant has been crimped and the implant alignment device 600 has been ejected from the crimping device 100 in the proximal direction. As the implant alignment device 600 is ejected, the guide elements 624 slide axially proximally along the axially extending portions 778. The protrusions 620 slide through the apertures 730 in the alignment guide 700 but the implant alignment device 600 is retained, at least partially, within the mounting portion 704. The prosthetic implant is in a crimped configuration at the target crimping location 232 of the balloon catheter 220.

[0190] FIGS. 9A-12 depict another example of an alignment assembly for crimping a prosthetic implant on a target crimping location relative to a delivery apparatus. The depicted example includes an implant alignment device 800, depicted in FIGS. 9A-9B, which is configured to be used with an alignment guide 900, depicted in FIGS. 10-11, such that the implant alignment device 800 is positioned partially within the alignment guide 900 as described in detail below. The implant alignment device 800 may share features with the implant alignment device 500, 600 and that the alignment guide 900 may share features with the alignment guide 400, 700.

[0191] In some examples, the implant alignment device 800 is the same as the implant alignment device 500, 600 and / or the alignment guide 700 is the same as the alignment guide 400, 700 except for the differences described below. It should be noted, however, that the alignment guides and or implant alignment devices described below need not include all of the components described above.

[0192] As depicted in FIGS. 9A-9B, the implant alignment device 800 comprises a coupling portion 802 and a support portion 804 (also referred to as an “implant support portion”). TheAttorney Docket No: THVMC-23892WO01 support portion 804 can be understood to be substantially similar to the support portion 604 of the implant alignment device 600. These similarities include a support surface 810, alignment members 806, alignment indicators 862, and a central channel 808 extending through the coupling portion 802 and the support portion 804. The support portion 804 can be configured to partially extend into the crimper aperture 130 of the crimping device 100 (from the proximal side portion 104 of the crimping device 100). The central channel 808 defines a central axis 801 and is sized and shaped to receive a delivery apparatus for the prosthetic implant therethrough (for example, delivery apparatus 200).

[0193] The coupling portion 802 can be configured to fit within the cavity 924 defined by mounting element 900a of the alignment guide 900, discussed below. In the depicted example, the implant alignment device 800 does not include a coupling member, similar to coupling member 622 of the implant alignment device 600, the rotational alignment of the coupling portion 802 and the crimping device is provided by other mechanisms. The coupling portion 802 can comprise axially extending groves which are sized and shaped to fit with corresponding axially extending rails on the internal surface of the mounting portion of the alignment guide. In the depicted example, there are three axially extending grooves 840 which are circumferentially spaced around the exterior surface of the coupling portion 802 and are sized and shaped to correspond to rails 940 on the internal surface of the mounting portion 904 of the alignment guide 900.

[0194] In some examples, the exterior surface of the coupling portion 802 may comprise one or more rails and the internal surface of the mounting portion may comprise one or more corresponding grooves.

[0195] In some examples, the coupling portion 802 may comprise one or more radially extending protrusions. In the depicted example there are two protrusions 842 for each axially extending groove 840 and the protrusions 842 are positioned on either side of each of the grooves 840 the protrusions 842 may be configured to interface with corresponding features on the internal surface of the mounting portion 904 of the alignment guide 900. In the depicted example, the coupling portion also comprises a circumferentially extending lip 844 which may be configured to interface with corresponding features of the internal surface of the mounting element 900a of the alignment guide 900.Attorney Docket No: THVMC-23892WO01

[0196] The alignment guide 900, depicted in FIGS. 10-11, may comprise two elements which may be removably coupled to one another: an alignment guide mounting element 900a (see FIG. 10) and an alignment guide positioning element 900b (see FIG. 11).

[0197] In some examples, the alignment guide mounting element 900a and the alignment guide positioning element 900b are removably coupled to one another.

[0198] In some examples, the alignment guide mounting element 900a comprises one or more clips and the alignment guide positioning element 900b comprises one or more corresponding notches. In the depicted example alignment guide mounting element 900a comprises three clips 960 and the alignment guide positioning element 900b three corresponding notches 964. The three clips 960 and the three notches 964 are circumferentially dispersed relative to the alignment guide mounting element 900a and the alignment guide positioning element 900b respectively.

[0199] In some examples, the alignment guide mounting element may comprise one or more notches and the alignment guide positioning element may comprise one or more clips.

[0200] The alignment guide positioning element 900b may have features which are configured to engage a distal end portion of the delivery apparatus and restrict axial and / or radial movement of the delivery apparatus relative to the alignment guide positioning element 900b. The positioning element 900b should be understood to work in substantially the same way as the positioning portion 402 described in detail including an upper jaw (see FIG. 3B) pivotably coupled via a hinge 908 and a locking mechanism 450 (see FIG. 3C). The positioning element 900b defines a longitudinal axis 901b.

[0201] In some examples, positioning the prosthetic implant delivery apparatus at a preselected position ensures that the prosthetic implant is crimped at the target crimping location. This may have the benefit of increasing accuracy and increasing uniformity in the prosthetic implant crimping location on the delivery apparatus.

[0202] In some examples, a distal wall 928 of the positioning element 900b comprises one or more windows 930 which are sized and shaped to allow corresponding protrusions 820 of the implant alignment device 800 to pass through as the prosthetic implant is crimped and the implant alignment device 800 is ejected from the crimping device in the proximal direction.Attomey Docket No: THVMC-23892WO01

[0203] The alignment guide mounting element 900a may have features which are configured to couple the alignment guide 900 to a crimping device, for example to the proximal side portion 104 of the crimping device 100. The alignment guide mounting element 900a can include one or more engagement members that are configured to mate with correspondingly shaped mating features on a side surface (e.g., proximal face) of a crimping device, such as the crimping device 100.

[0204] In some examples, the mounting element 900a comprises a cylindrical wall which forms a cylindrical, or a partial cylindrical shape, and is sized and shaped to fit with the proximal side portion 104 of the crimping device 100. The engagement members can be disposed radially outward from an inner cavity 924 and configured to releasably secure the alignment guide mounting element 900a to a crimping device such as to the proximal side portion 104 of the crimping device 100.

[0205] In some examples, the engagement members comprises a plurality of arms 912 which extend radially outward from the inner cavity 924 in a spiral arm pattern. The plurality of arms 912 are sized and shaped to fit with corresponding features on the proximal side portion 104 of the crimping device 100, such as one or more slots 106. In the depicted example, the mounting element 900a comprises three arms 912.

[0206] In some examples, the mounting element 900a is configured to be twisted around the longitudinal axis to couple with the proximal side portion 104 of the crimping device 100.

[0207] In some examples, the mounting element 900a is configured to be coupled with the proximal side portion 104 of the crimping device 100 by rotating the alignment guide 900 relative to the crimping device 100.

[0208] In some examples, the alignment guide 900 is rotated a quarter turn relative to the crimping device 100. This configuration may have the advantage of ensuring a secure connection between the plurality of arms 912 and the one or more slots 106.

[0209] In some examples, the mounting element 900a can have different configurations, such as a recess, snap-in feature, or alternate alignment features that are configured to mate with a corresponding mating interface of the crimping device 100. As one example, the mounting element 900a may comprise one or more recess and the distal side portion of the crimping device may comprise a corresponding one or more arms.Attomey Docket No: THVMC-23892WO01

[0210] In some examples, the mounting element has one or more features which are configured to interface with the implant alignment device 800. In the depicted example, the mounting element 900a defines an inner cavity 924 which is sized and shaped to receive an implant alignment device and / or a portion thereof. The inner cavity defines a longitudinal axis 901a.The inner cavity 924 is configured to receive the coupling portion 802 of the implant alignment device 800. Features on the internal surface of the mounting element 900a may be configured to interact with features of the coupling portion 802.

[0211] In some examples, the inner surface of the mounting element 900a comprises one or more rails. In the depicted example, the inner surface of the mounting element 900a comprises three rails 940 sized and shaped to correspond to three axially extending grooves 840 which are circumferentially spaced around the exterior surface of the coupling portion 802.

[0212] In some examples the rails 940 and the grooves 840 prevent circumferential movement of the implant alignment device 800 relative to the alignment guide 900.

[0213] In some examples, there can be a first ledge 942 which is sized and shaped to correspond to the protrusions 842 which are on either side of each axially extending groove 840 on the coupling portion 802 of the implant alignment device 800.

[0214] In some examples, a second ledge 944 on the internal surface of the mounting element 900a is configured to interact with a corresponding the coupling portion also comprises a circumferentially extending lip 844.

[0215] In some examples, the implant alignment device 800 is configured to enter the inner cavity 924 from a proximal side and the circumferentially extending first ledge 942 and / or second ledge 944 prevent the implant alignment device 800 from sliding all the way distally through the mounting element 900a.

[0216] FIG. 12 depicts the implant alignment device 800 and the two portions of the alignment guide 900 all positioned on a shared axis 801, 901a, 901b. Also depicted is a spacer 1000 which can be used to maintain the position of the implant alignment device 800 within the inner cavity 924 of the mounting element 900a, for example, during product shipping. The spacer can comprise a flange 1002, a distally extending wall 1004 and a plurality of supports 1006. The distally extending wall is configured to be inserted into the inner cavity 924 and the supports 1006 are configured to interface with the rails 940. When the spacer 1000 is installed into theAttorney Docket No: THVMC-23892WO01 inner cavity 924 it prevents the implant alignment device 800 from sliding axially proximally relative to the mounting element 900a and maintains the implant alignment device 800 at a desired position at least partially within the mounting element 900a.

[0217] In some examples, the use of the alignment assembly, comprises positioning a prosthetic valve 300 onto the implant alignment device 800 wherein a proximal end portion of the implant alignment device 800 is positioned within the inner cavity 924 of the mounting element 900a. The prosthetic valve 300 and a distal end portion of the implant alignment device 800 may then be positioned within a crimper aperture 130 of a crimping device 100. The mounting element 900a is then coupled to the proximal side portion 104 of the crimping device 100, such that the prosthetic implant 300 is axially aligned with the jaws 114 of the crimping device 100. A distal portion 224 of the balloon catheter 220 may then be secured within a positioning element 900b of the alignment guide 900. The target crimp location 232 is then positioned through the central channel 808 of the implant alignment device 800 and within the prosthetic implant 300, such that a target crimping location 232 of the balloon catheter 220 is axially aligned with the jaws 114 of the crimping device 100. The distal wall 928 of the positioning element 900b is coupled to a proximal end portion of the mounting element 900a using clips 960 and the corresponding notches 964. When the actuator handle 120 of the crimping device 100 is actuated to decrease the diameter of the crimper aperture 130 the implantable prosthetic valve 300 is crimped and the implant alignment device 800 slides axially proximally relative to the crimping device 100 and the alignment guide 900.

[0218] In some examples, as the implant alignment device moves proximally, the protrusions 820 of the implant alignment device 800 pass through the distal wall 928 of the positioning element 900b.

[0219] The apparatuses and methods described above can be used to crimp a prosthetic implant onto an inflatable balloon with a tightly compressed profile and at a precise target crimping location relative to the delivery apparatus. In order to ensure that the balloon reliably expands the frame of the implant after the implant reaches a target implantation site in the subject’s vasculature, it may be beneficial to ensure that the crimping process results in the implant being crimped accurately onto the balloon at a repeatably precise location. Manually aligning and mounting the prosthetic implant directly onto the inflatable balloon presents challenges and mayAttorney Docket No: THVMC-23892WO01 require extensive training for users. It is desirable to increase automation in the valve crimping process, which in turn can increase accuracy and uniformity of the positioning of the crimped prosthetic implants while reducing the amount of training required for users to proficiently place the prosthetic implants. The proper placement of the crimped prosthetic implant at the target crimping location on the balloon helps to ensure a predictable deployment. An accurate and precise crimp at the target crimping location helps to ensure repeatable and reliable implant expansion and deployment shape of the frame. The crimping tools described above can help to ensure repeatability and reliability.

[0220] FIG. 13 shows a prosthetic heart valve 1100, which can be one specific example of the prosthetic valve 300 described above. As shown, the prosthetic heart valve 1100 comprises an annular frame, or stent, 1102 which can support a leaflet structure 1104 and / or an outer skirt 1106. In some examples, the prosthetic heart valve 1100 is adapted to be implanted in a native valve (e.g., in the native mitral, tricuspid, aortic, pulmonic valve) and can be implanted in the body using, for example, the delivery apparatus 200 described above. The prosthetic valve 1100 can also be implanted within the body using any of the other delivery apparatuses described herein.

[0221] In some examples, the frame 1102 comprises a plastically expandable material, which can be metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal.

[0222] In some examples, the frame 1102 can comprise stainless steel. In some examples, the frame 1 102 can comprise cobalt-chromium.

[0223] In some examples, the frame 1102 can comprise nickel-cobalt-chromium.

[0224] In some examples, the frame 1102 comprises a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.Delivery TechniquesAttorney Docket No: THVMC-23892WO01

[0225] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-stemotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

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

[0227] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be usedAttorney Docket No: THVMC-23892WO01 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.

[0228] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0229] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a subject’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

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

[0231] The techniques, methods, steps, etc. described or suggested herein or in references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example,Attorney Docket No: THVMC-23892WO01 with the body parts, tissue, etc. being simulated), etc. When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if demonstrating in the air on an imaginary heart), etc.Additional Examples of the Disclosed Technology

[0232] 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.

[0233] Example 1. An alignment assembly for crimping a prosthetic implant, comprising: an alignment guide comprising a mounting element defining an inner cavity and an outer surface, wherein the outer surface is positioned radially outward from the inner cavity and comprises one or more engagement members configured to secure the mounting element to a crimping device; and an implant alignment device moveably coupled to the mounting element and comprising a support portion and a coupling portion, wherein the support portion is configured to support a prosthetic implant on a distal end portion and extend at least partially within a central channel of the crimping device, and wherein the coupling portion is configured to extend at least partially within the inner cavity of the mounting element such that the implant alignment device and the mounting element are slidable relative to one another.

[0234] Example 2. The alignment assembly of any example herein, particularly example 1, further comprising a spacer sized and shaped to fit within the inner cavity of the mounting element and configured to maintain the implant alignment device at a desired position within the inner cavity of the mounting element.

[0235] Example 3. The alignment assembly of any example herein, particularly example 1, wherein the alignment guide further comprises a positioning element coupled to a proximal end portion of the mounting element and configured to receive a shaft portion of a distal end portionAttorney Docket No: THVMC-23892WO01 of a delivery apparatus for a prosthetic implant and prevent axial and radial movement relative to the positioning element.

[0236] Example 4. The alignment assembly of any example herein, particularly example 3, wherein the positioning element and the mounting element are two separate elements which are removably coupled to one another.

[0237] Example 5. The alignment assembly of any example herein, particularly any one of examples 3-4, wherein the positioning element of the alignment guide further comprises one or more retention members.

[0238] Example 6. The alignment assembly of any example herein, particularly any one of examples 3-4, further comprising one or more clips extending in a proximal direction from the mounting element and a distal wall of the positioning element with one or more notches, wherein the one or more clips are configured to couple with the one or more notches.

[0239] Example 7. The alignment assembly of any example herein, particularly any one of examples 1-6, wherein an internal surface of the mounting element comprises one or more rails and an outer surface of the implant alignment device comprises one or more slots sized and shaped to fit the one or more rails.

[0240] Example 8. The alignment assembly of any example herein, particularly example 7. wherein the mounting element and the implant alignment device define a longitudinal axis and the one or more rails and the one or more slots extend in a direction that is parallel to the longitudinal axis.

[0241] Example 9. The alignment assembly of any example herein, particularly any one of examples 7-8, wherein the one or more rails and one or more slots are configured to prevent circumferential movement of the implant alignment device relative to the alignment guide.

[0242] Example 10. The alignment guide of any example herein, particularly any one of examples 1-6, wherein an internal surface of the mounting element comprises one or more slots and the coupling portion of the implant alignment device comprises one or more guide elements, wherein the guide elements are configured to slide within the slots.

[0243] Example 11. The alignment assembly of any example herein, particularly example 10, wherein the slots comprise a lodging portion, wherein when the guide elements are in the lodgingAttorney Docket No; THVMC-23892WO01 portion, the alignment guide and the implant alignment device are axially fixed relative to one another.

[0244] Example 12. The alignment guide of any example herein, particularly any one of examples 10-11, wherein the slots comprise an axial extending portion, and wherein when the guide elements are in the axially extending portion of the slots the implant alignment device is configured to slide axially relative to the alignment guide.

[0245] Example 13. The alignment assembly of any example herein, particularly any one of examples 1-12, wherein the prosthetic implant comprises a prosthetic valve.

[0246] Example 14. The alignment assembly of any example herein, particularly any one of examples 1-12, wherein the prosthetic implant comprises a stent.

[0247] Example 15. An alignment assembly for crimping a prosthetic implant, comprising: an alignment guide comprising: a mounting portion defining an inner cavity and an outer surface, wherein the outer surface comprises one or more engagement members configured to secure the mounting portion to a crimping device; and a positioning portion coupled to the mounting portion and extending in a proximal direction configured to receive a shaft portion of a distal end portion of a delivery apparatus; and an implant alignment device moveably coupled to the mounting portion of the alignment guide and comprising a support portion and a coupling portion, wherein the support portion is configured to support a prosthetic implant on a distal end portion and extend at least partially within a central channel of the crimping device, and wherein the coupling portion is configured to extend at least partially within the inner cavity of the mounting portion such that the implant alignment device and the mounting portion are slidable relative to one another.

[0248] Example 16. The alignment assembly of any example herein, particularly example 15, wherein the positioning portion is configured to retain the shaft portion of the distal end portion of a delivery apparatus such that a target crimping location of the delivery apparatus extends into the central channel of the crimping device.

[0249] Example 17. The alignment assembly of any example herein, particularly example 16, wherein the implant alignment device is configured to position the prosthetic implant around the target crimping location within the central channel of the crimping device.Attorney Docket No: THVMC-23892WO01

[0250] Example 18. The alignment assembly of any example herein, particularly any one of examples 15-17, wherein the implant alignment device further comprises a coupling member positioned on an outer diameter of the implant alignment device which is configured to fit within a slot in the crimping device, wherein crimping the prosthetic implant results in the coupling member sliding out of and detaching from the crimping device.

[0251] Example 19. The alignment assembly of any example herein, particularly any one of examples 15-18, wherein the mounting portion of the alignment guide further comprises a proximal wall which comprises one or more apertures and the coupling portion of the implant alignment device further comprises one or more protrusions, wherein the apertures are configured to allow the protrusions to pass through as the implant alignment device slides in the proximal direction relative to the alignment guide.

[0252] Example 20. The alignment assembly of any example herein, particularly any one of examples 15-19, wherein the inner cavity of the mounting portion comprises one or more slots and the coupling portion of the implant alignment device comprises one or more guide elements, wherein the guide elements are configured to slide within the slots.

[0253] Example 21. The alignment assembly of any example herein, particularly example 20, wherein the slots comprise a lodging portion, wherein when the guide elements are in the lodging portion, the alignment guide and the implant alignment device are axially fixed relative to one another.

[0254] Example 22. The alignment guide of any example herein, particularly any one of examples 20-21, wherein the slots comprise an axial extending portion, and wherein when the guide elements are in the axially extending portion of the slots the implant alignment device is configured to slide axially relative to the alignment guide.

[0255] Example 23. The alignment assembly of any example herein, particularly any one of examples 15-22, wherein the prosthetic implant comprises a prosthetic valve.

[0256] Example 24. The alignment assembly of any example herein, particularly any one of examples 15-22, wherein the prosthetic implant comprises a stent.

[0257] Example 25. An assembly for crimping a prosthetic implant on a delivery apparatus, the assembly comprising: a crimping device comprising a central channel, a first side portion, and aAttorney Docket No; THVMC-23892WO01 second side portion, wherein the central channel extends from the first side portion to the second side portion; an alignment guide coupled to the first side portion of the crimping device and configured to receive a distal end portion of a delivery apparatus and position a target crimping location of the distal end portion of the delivery apparatus within the central channel of the crimping device; and an implant alignment device slidably coupled to the alignment guide, and configured to position a prosthetic implant around the target crimping location of the distal end portion of the delivery apparatus and within the central channel of the crimping device.

[0258] Example 26. The assembly of any example herein, particularly example 25, wherein the alignment guide comprises a positioning portion extending in a proximal direction from the first side portion of the crimping device and configured to receive a shaft portion of the distal end portion of a delivery apparatus.

[0259] Example 27. The assembly of any example herein, particularly example 26, wherein the positioning portion of the alignment guide further comprises one or more retention members configured to retain the shaft portion of the distal end portion of the delivery apparatus and prevent axial and radial movement relative to the alignment guide.

[0260] Example 28. The assembly of any example herein, particularly any one of examples 25-27, wherein the alignment guide comprises a mounting portion coupled to a distal end of the positioning portion and having an inner diameter defining an inner cavity and an outer surface wherein the outer surface comprises one or more engagement members configured to couple with a crimping device; and the implant alignment device is sized and shaped to fit at least partially within the inner diameter of the mounting portion such that the implant alignment device and the mounting portion are slidable relative to one another, and wherein the implant alignment device is configured to extend at least partially within a central channel of the crimping device.

[0261] Example 29. The assembly of any example herein, particularly any one of examples 25-28, wherein the implant alignment device has a coupling member positioned on an outer diameter of the implant alignment device which is sized and shaped to fit within a slot in the crimping device, wherein crimping the prosthetic implant results in the coupling member sliding out of and detaching from the crimping device.Attorney Docket No; THVMC-23892WO01

[0262] Example 30. An alignment guide for a delivery apparatus, the alignment guide comprising: a positioning portion configured to receive a shaft portion of a distal end portion of a delivery apparatus for a prosthetic implant and to position a target crimping location of a distal end portion of a delivery apparatus within a central channel of a crimping device; and a mounting portion coupled to a distal end portion of the positioning portion comprising an inner cavity, an outer surface, and one or more engagement members coupled to the outer surface and disposed radially outward from the inner cavity, and configured to releasably secure the alignment guide to a first side portion of a crimping device.

[0263] Example 31. The alignment guide of any example herein, particularly example 30 wherein the positioning portion comprises one or more jaws, configured to prevent movement of the delivery apparatus relative to the crimping device.

[0264] Example 32. The alignment guide of any example herein, particularly any one of examples 30-31, wherein the positioning portion is configured to restrict circumferential movement of the delivery apparatus relative to the crimping device.

[0265] Example 33. The alignment guide of any example herein, particularly any one of examples 30-32 wherein the positioning portion is configured to restrict axial movement of the delivery apparatus relative to the crimping device

[0266] Example 34. The alignment guide of any example herein, particularly any one of examples 30-33, wherein the alignment guide further comprising a locking mechanism configured to lock the one or more jaws in a closed position.

[0267] Example 35. The alignment guide of any example herein, particularly any one of examples 30-34, wherein the positioning portion and the mounting portion comprise two separate pieces which are releasably coupled to one another.

[0268] Example 36. An assembly for crimping a prosthetic implant on a delivery apparatus, comprising: a crimping device; the alignment guide of any example herein, particularly any one of examples 30-36 coupled to the first side portion of the crimping device; and an implant alignment device disposed within the inner cavity of the mounting portion of the alignment guide and coupled to the first side portion of the crimping device.Attorney Docket No: THVMC-23892WO01

[0269] Example 37. The assembly of any example herein, particularly example 36, wherein the implant alignment device comprises: a coupling portion configured to fit at least partially within the inner cavity of the mounting portion such that the implant alignment device and the mounting portion are slidable relative to one another, and wherein the implant alignment device is configured to extend at least partially within a central channel of the crimping device; a support portion coupled to the coupling portion, the support portion tapers from a wider end that is disposed adjacent to the coupling portion to a narrower end portion, wherein the support portion comprises an outward facing support surface that is configured to receive a prosthetic implant thereon; and a central channel defining a longitudinal axis and extending through the coupling portion and the support portion, the central channel configured to receive a delivery apparatus therethrough.

[0270] Example 38. The assembly of any example herein, particularly example 37, wherein the coupling portion comprises a coupling member, wherein the coupling member is positioned radially outward from the support portion and sized and shaped to within a slot in the crimping device.

[0271] Example 39. The assembly of any example herein, particularly any one of examples 37- 38, further comprising one or more one or more axially extending alignment members, each alignment member extends axially from the wider end of the support portion, wherein the one or more axially extending alignment members extend over the narrower end portion of the support portion, each alignment member comprising a free end configured to abut an end of the prosthetic implant.

[0272] Example 40. A method of mounting a prosthetic implant to a delivery apparatus, the method comprising: positioning a prosthetic implant onto an implant alignment device; coupling a prosthetic implant delivery apparatus to an alignment guide; loading the implant alignment device within the alignment guide; positioning a distal end portion of the prosthetic implant delivery apparatus, the prosthetic implant, and a distal end portion of the implant alignment device within a central channel of a crimping device.

[0273] Example 41. The method of any example herein, particularly example 40, wherein loading the implant alignment device within the alignment guide comprises positioning theAttomey Docket No: THVMC-23892WO01 implant alignment device in a lodging position such that the implant alignment device is axially fixed relative to the alignment guide.

[0274] Example 42. The method of any example herein, particularly example 41, further comprising placing the implant alignment guide in an actuation position by rotating the alignment guide relative to the implant alignment device resulting in the implant alignment device being free to move axially relative to the alignment guide.

[0275] Example 43. The method of any example herein, particularly any one of examples 40-42, further comprising crimping the prosthetic implant, resulting in a crimped prosthetic implant.

[0276] Example 44. The method of any example herein, particularly example 43 wherein crimping the prosthetic implant results in the implant alignment device moving axially relative to the alignment guide.

[0277] Example 45. A method of mounting a prosthetic implant to a delivery apparatus, the method comprising: positioning a prosthetic implant onto an implant alignment device; positioning a distal end portion of a prosthetic implant delivery apparatus within a support portion of an alignment guide; inserting a proximal portion of the implant alignment device within an inner cavity of a mounting portion of the alignment guide which results in a balloon catheter of the prosthetic implant delivery apparatus being positioned within a central channel of the implant alignment device and within a central passage of the prosthetic implant; and positioning the balloon catheter, the prosthetic implant, and a distal end portion of the implant alignment device within a central channel of a crimping device and coupling the implant alignment device and the mounting portion of the alignment guide to a proximal side portion of the crimping device, such that the prosthetic implant is axially aligned with compression elements of the crimping device.

[0278] Example 46. A method of mounting a prosthetic implant to a delivery apparatus, the method comprising: positioning a prosthetic implant onto an implant alignment device, wherein a proximal end portion of the implant alignment device is positioned within a mounting portion which comprises an inner cavity and an outer surface, wherein the outer surface comprises one or more engagement members configured to couple the mounting portion to a crimping device; positioning the prosthetic implant and a distal end portion of the implant alignment device within a central channel of a crimping device; coupling the mounting portion to a proximal side portionAttorney Docket No; THVMC-23892WO01 of the crimping device, such that the prosthetic implant is axially aligned with compression elements of the crimping device; positioning a distal end portion of a prosthetic implant delivery apparatus within a positioning portion of an alignment guide; inserting a balloon catheter of the prosthetic implant delivery apparatus within a central channel of the implant alignment device, a central passage of the prosthetic implant, such that a target crimping location of the balloon catheter is axially aligned with compression elements of the crimping device; coupling a distal end portion of the positioning portion of the alignment guide to a proximal end portion of the implant alignment device.

[0279] Example 47. The method of any example herein, particularly example 46 further comprising, prior to inserting a balloon catheter of the prosthetic implant delivery apparatus within a central channel of the implant alignment device, removing a spacer which is configured to maintain the implant alignment device at a desired position within the inner cavity of the mounting portion.

[0280] Example 48. The method of any example herein, particularly any one of examples 45-47, further comprising crimping the prosthetic implant, resulting in a crimped prosthetic implant.

[0281] Example 49. The method of any example herein, particularly example 48, wherein crimping the prosthetic implant comprises one or more crimping motions, wherein each of the crimping motions has the result of ensuring the prosthetic implant is properly crimped.

[0282] Example 50. The method of any example herein, particularly any one of examples 48-49, wherein crimping the prosthetic implant results in the implant alignment device moving axially within the inner cavity of the mounting portion and being ejected from the crimping device.

[0283] Example 51. The method of any example herein, particularly example 50, wherein the implant alignment device is retained within the inner cavity of the mounting portion.

[0284] Example 52. The method of any example herein, particularly any one of examples 45-51, wherein the prosthetic implant comprises one or more commissures and positioning the prosthetic implant onto the implant alignment device comprises aligning the one or more commissures with one or more markings one the implant alignment device.

[0285] Example 53. The method of any example herein, particularly any one of examples 48-52, further comprising removing the balloon catheter and the crimped prosthetic implant, which isAttorney Docket No: THVMC-23892WO01 now disposed on the balloon catheter, from the alignment guide, crimping device, and implant alignment device.

[0286] Example 54. The method of any example herein, particularly example 53, further comprising inserting the delivery apparatus into a subject’s vasculature.

[0287] Example 55. The method of any example herein, particularly any one of examples 45-54, wherein the prosthetic implant comprises a prosthetic valve.

[0288] Example 56. The method of any example herein, particularly any one of examples 45-54, wherein the prosthetic implant comprises a stent.

[0289] Example 57. An alignment assembly for crimping a prosthetic implant, comprising: an alignment guide comprising a mounting element defining an inner cavity and an outer surface, wherein the outer surface is positioned radially outward from the inner cavity and comprises one or more engagement members configured to secure the mounting element to a crimping device; and an implant alignment device comprising a support portion and a coupling portion, wherein the support portion is configured to support a prosthetic implant on a distal end portion and extend at least partially within a central channel of the crimping device, and wherein at least a portion of the implant alignment device is slidably positioned within the inner cavity of the mounting element, such that the implant alignment device is slidable relative to the mounting element.

[0290] Example 58. The alignment assembly of any example herein, particularly example 57, further comprising a spacer sized and shaped to fit at least partially within the inner cavity of the mounting element and configured to maintain the implant alignment device at a desired position within the inner cavity of the mounting element.

[0291] Example 59. The alignment assembly of any example herein, particularly example 57, wherein the alignment guide further comprises a positioning element coupled to and / or extending from a proximal end portion of the mounting element and configured to receive a shaft portion of a distal end portion of a delivery apparatus for a prosthetic implant and prevent axial and radial movement relative to the positioning element.Attorney Docket No: THVMC-23892WO01

[0292] Example 60. The alignment assembly of any example herein, particularly example 59, wherein the positioning element and the mounting element are two separate elements which are removably coupled to one another.

[0293] Example 61. The alignment assembly of any example herein, particularly any one of examples 59-60, wherein the positioning element of the alignment guide further comprises one or more retention members.

[0294] Example 62. The alignment assembly of any example herein, particularly any one of examples 59-60, further comprising one or more clips extending in a proximal direction from the mounting element and a distal wall of the positioning element with one or more notches, wherein the one or more clips are configured to couple with the one or more notches.

[0295] Example 63. The alignment assembly of any example herein, particularly any one of examples 57-62, wherein an internal surface of the mounting element comprises one or more rails and an outer surface of the implant alignment device comprises one or more slots sized and shaped to fit the one or more rails.

[0296] Example 64. The alignment assembly of any example herein, particularly example 63, wherein the mounting element and the implant alignment device define a longitudinal axis and the one or more rails and the one or more slots extend in a direction that is parallel to the longitudinal axis.

[0297] Example 65. The alignment assembly of any example herein, particularly any one of examples 63-64, wherein the one or more rails and one or more slots are configured to prevent circumferential movement of the implant alignment device relative to the alignment guide.

[0298] Example 66. The alignment guide of any example herein, particularly any one of examples 57-62, wherein an internal surface of the mounting element comprises one or more slots and the coupling portion of the implant alignment device comprises one or more guide elements, wherein the guide elements are configured to slide within the slots.

[0299] Example 67. The alignment assembly of any example herein, particularly example 66, wherein the slots comprise a lodging portion, wherein when the guide elements are in the lodging portion, the alignment guide and the implant alignment device are axially fixed relative to one another.Attorney Docket No; THVMC-23892WO01

[0300] Example 68. The alignment guide of any example herein, particularly any one of examples 66-67, wherein the slots comprise an axial extending portion, and wherein when the guide elements are in the axially extending portion of the slots the implant alignment device is configured to slide axially relative to the alignment guide.

[0301] Example 69. The alignment assembly of any example herein, particularly any one of examples 57-68, wherein the prosthetic implant comprises a prosthetic valve.

[0302] Example 70. The alignment assembly of any example herein, particularly any one of examples 57-69, wherein the prosthetic implant comprises a stent.

[0303] Example 71. An assembly for crimping a prosthetic implant on a delivery apparatus, the assembly comprising: a crimping device comprising a central channel, a first side portion, and a second side portion, wherein the central channel extends from the first side portion to the second side portion; an alignment guide configured to couple to the first side portion of the crimping device, the alignment guide configured to receive a portion of a delivery apparatus such that a target crimping location of a distal end portion of the delivery apparatus is positioned within the central channel of the crimping device; and an implant alignment device configured to be at least partially and slidably positioned within an inner cavity of the alignment guide, the implant alignment device configured to position a prosthetic implant around the target crimping location of the distal end portion of the delivery apparatus and within the central channel of the crimping device.

[0304] Example 72. The alignment assembly of any example herein, particularly example 71, wherein the implant alignment device further comprises a coupling member positioned on an outer diameter of the implant alignment device which is configured to fit within a slot in the crimping device, wherein crimping the prosthetic implant results in the coupling member sliding out of and detaching from the crimping device.

[0305] Example 73. The alignment assembly of any example herein, particularly any one of examples 71-72, wherein the alignment guide comprises a mounting portion, wherein the mounting portion is configured to couple to the first side portion of the crimping device, and wherein the mounting portion further comprises a proximal wall which comprises one or more apertures and a coupling portion of the implant alignment device comprises one or moreAttorney Docket No: THVMC-23892WO01 protrusions, wherein the apertures are configured to allow the protrusions to pass through as the implant alignment device slides in the proximal direction relative to the alignment guide.

[0306] Example 74. The alignment assembly of any example herein, particularly any one of examples 71-73, wherein the prosthetic implant comprises a prosthetic valve.

[0307] Example 75. The alignment assembly of any example herein, particularly any one of examples 71-73, wherein the prosthetic implant comprises a stent.

[0308] Example 76. The alignment assembly of any example herein, particularly example 71. wherein the alignment guide comprises a mounting element defining an inner cavity and an outer surface, wherein the outer surface is positioned radially outward from the inner cavity and comprises one or more engagement members configured to secure the mounting element to a crimping device.

[0309] Example 77. The alignment assembly of any example herein, particularly any one of examples 71 and 76, wherein the implant alignment device comprises a support portion and a coupling portion.

[0310] Example 78. The alignment assembly of any example herein, particularly example 73, wherein the coupling portion is configured to extend at least partially within the inner cavity of the alignment guide such that the implant alignment device and the alignment guide are slidable relative to one another.

[0311] Example 79. The alignment assembly of any example herein, particularly example 71, wherein the alignment guide comprises a positioning portion extending in a proximal direction from the first side portion of the crimping device and configured to receive the portion of the delivery apparatus such that a target crimping location of a distal end portion of the delivery apparatus is positioned within the central channel of the crimping device.

[0312] Example 80. The alignment assembly of any example herein, particularly any of examples 73, wherein the implant alignment device is sized and shaped to fit at least partially within the inner diameter of the mounting portion.

[0313] Thus, specific examples of alignment assemblies, devices, and methods have been disclosed. The above description of the disclosed implementations is provided to enable any person skilled in the art to make or use the assemblies, devices and methods disclosed herein.Attorney Docket No: THVMC-23892WO01The preceding detailed description illustrates examples and is not intended to limit the disclosure or the application and uses of the assemblies, devices and methods disclosed herein. Various modifications to these implementations will be readily apparent to those skilled in the art, and the general principles described herein can be applied to other implementations without departing from the spirit or scope of the disclosure.

[0314] Reference throughout this specification to “an implementation” means that a particular feature, structure, or characteristic described in connection with the implementation is included in at least one implementation. Thus, appearances of the phrases “in an implementation” in various places throughout this specification are not necessarily all referring to the same implementation or a single exclusive implementation. Furthermore, the particular features, structures, or characteristics described herein may be combined in any suitable manner in one or more implementations.

[0315] The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any aspect described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects. Unless specifically stated otherwise, the term “some” refers to one or more.

[0316] It will be understood that the benefits and advantages described above can relate to one implementation or can relate to several implementations. Aspects described in connection with one implementation are intended to be able to be used with the other implementation. Any explanation in connection with one implementation applies to similar features of the other implementations, and elements of multiple implementations can be combined to form other implementations. The implementations are not limited to those that solve any or all of the stated problems or those that have any or all of the stated benefits and advantages.

[0317] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain implementations herein is intended merely to better illuminate the assemblies, devices and methods disclosed herein and does not pose a limitation on the scope of the disclosure otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the disclosure.Attorney Docket No: THVMC-23892WO01

[0318] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of one alignment assembly can be combined with any one or more features of another alignment assembly. As another example, any one or more features of one alignment guide can be combined with any one or more features of another alignment guide. As another example, any one or more features of one implant alignment device can be combined with any one or more features of another implant alignment device.

[0319] 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.

[0320] Groupings of alternative elements or implementations of the disclosure herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all groups used in the appended claims.

[0321] All structural and functional equivalents to the components of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

Claims

Attorney Docket No: THVMC-23892WO01What is claimed is:

1. An alignment assembly for crimping a prosthetic implant, comprising: an alignment guide comprising a mounting element defining an inner cavity and an outer surface, wherein the outer surface is positioned radially outward from the inner cavity and comprises one or more engagement members configured to secure the mounting element to a crimping device; and an implant alignment device moveably coupled to the mounting element and comprising a support portion and a coupling portion, wherein the support portion is configured to support a prosthetic implant on a distal end portion and extend at least partially within a central channel of the crimping device, and wherein the coupling portion is configured to extend at least partially within the inner cavity of the mounting element such that the implant alignment device and the mounting element are slidable relative to one another.

2. The alignment assembly of claim 1 , wherein the alignment guide further comprises a positioning element coupled to a proximal end portion of the mounting element and configured to receive a shaft portion of a distal end portion of a delivery apparatus for a prosthetic implant and prevent axial and radial movement relative to the positioning element.

3. The alignment assembly of any one of claims 1-2, wherein the positioning element of the alignment guide further comprises one or more retention members.

4. The alignment assembly of claim 2, further comprising one or more clips extending in a proximal direction from the mounting element and a distal wall of the positioning element comprises one or more notches, wherein the one or more clips are configured to couple with the one or more notches.

5. The alignment assembly of any one of claims 1-4, wherein an internal surface of the mounting element comprises one or more rails and an outer surface of the implant alignment device comprises one or more slots sized and shaped to fit the one or more rails.Attorney Docket No: THVMC-23892WO016. The alignment assembly of claim 5, wherein the mounting element and the implant alignment device define a longitudinal axis and the one or more rails and the one or more slots extend in a direction that is parallel to the longitudinal axis.

7. The alignment guide of any one of claims 1-4, wherein an internal surface of the mounting element comprises one or more slots and the coupling portion of the implant alignment device comprises one or more guide elements, wherein the guide elements are configured to slide within the slots.

8. The alignment assembly of claim 7, wherein the slots comprise a lodging portion, wherein when the guide elements are in the lodging portion, the alignment guide and the implant alignment device are axially fixed relative to one another.

9. The alignment guide of any one of claims 7-8, wherein the slots comprise an axial extending portion, and wherein when the guide elements are in the axially extending portion of the slots the implant alignment device is configured to slide axially relative to the alignment guide.

10. The alignment assembly of any one of claims 1-9, wherein the prosthetic implant comprises a prosthetic valve.

11. The alignment assembly of any one of claims 1-9, wherein the prosthetic implant comprises a stent.

12. An assembly for crimping a prosthetic implant on a delivery apparatus, the assembly comprising: a crimping device comprising a central channel, a first side portion, and a second side portion, wherein the central channel extends from the first side portion to the second side portion; an alignment guide coupled to the first side portion of the crimping device and configured to receive a distal end portion of a delivery apparatus and position a target crimping location ofAttorney Docket No; THVMC-23892WO01 the distal end portion of the delivery apparatus within the central channel of the crimping device; and an implant alignment device slidably coupled to the alignment guide, and configured to position a prosthetic implant around the target crimping location of the distal end portion of the delivery apparatus and within the central channel of the crimping device.

13. The assembly of claim 12, wherein the alignment guide comprises a positioning portion extending in a proximal direction from the first side portion of the crimping device and configured to receive a shaft portion of the distal end portion of a delivery apparatus.

14. The assembly of claim 13, wherein the positioning portion of the alignment guide further comprises one or more retention members configured to retain the shaft portion of the distal end portion of the delivery apparatus and prevent axial and radial movement relative to the alignment guide.

15. The assembly of any one of claims 12-14, wherein the alignment guide comprises a mounting portion coupled to a distal end of the positioning portion and having an inner diameter defining an inner cavity and an outer surface wherein the outer surface comprises one or more engagement members configured to couple with a crimping device; and the implant alignment device is sized and shaped to fit at least partially within the inner diameter of the mounting portion such that the implant alignment device and the mounting portion are slidable relative to one another, and wherein the implant alignment device is configured to extend at least partially within a central channel of the crimping device.

16. The assembly of any one of claims 12-15, wherein the implant alignment device has a coupling member positioned on an outer diameter of the implant alignment device which is sized and shaped to fit within a slot in the crimping device, wherein crimping the prosthetic implant results in the coupling member sliding out of and detaching from the crimping device.

17. An alignment guide for a delivery apparatus, the alignment guide comprising:Attorney Docket No; THVMC-23892WO01 a positioning portion configured to receive a shaft portion of a distal end portion of a delivery apparatus for a prosthetic implant and to position a target crimping location of a distal end portion of a delivery apparatus within a central channel of a crimping device; and a mounting portion coupled to a distal end portion of the positioning portion comprising an inner cavity, an outer surface, and one or more engagement members coupled to the outer surface and disposed radially outward from the inner cavity, and configured to releasably secure the alignment guide to a first side portion of a crimping device.

18. A method of mounting a prosthetic implant to a delivery apparatus, the method comprising: positioning a prosthetic implant onto an implant alignment device, wherein a proximal end portion of the implant alignment device is positioned within a mounting portion which comprises an inner cavity and an outer surface, wherein the outer surface comprises one or more engagement members configured to couple the mounting portion to a crimping device; positioning the prosthetic implant and a distal end portion of the implant alignment device within a central channel of a crimping device; coupling the mounting portion to a proximal side portion of the crimping device, such that the prosthetic implant is axially aligned with compression elements of the crimping device; positioning a distal end portion of a prosthetic implant delivery apparatus within a positioning portion of an alignment guide; inserting a balloon catheter of the prosthetic implant delivery apparatus within a central channel of the implant alignment device, a central passage of the prosthetic implant, such that a target crimping location of the balloon catheter is axially aligned with compression elements of the crimping device; coupling a distal end portion of the positioning portion of the alignment guide to a proximal end portion of the implant alignment device.

19. The method of claim 18 further comprising, prior to inserting a balloon catheter of the prosthetic implant delivery apparatus within a central channel of the implant alignment device, removing a spacer which is configured to maintain the implant alignment device at a desired position within the inner cavity of the mounting portion.Attorney Docket No; THVMC-23892WO0120. The method of any one of claims 18-19, further comprising crimping the prosthetic implant, resulting in a crimped prosthetic implant.

21. The method of claim 20, wherein crimping the prosthetic implant results in the implant alignment device moving axially within the inner cavity of the mounting portion and being ejected from the crimping device.

22. An alignment assembly for crimping a prosthetic implant, comprising: an alignment guide comprising a mounting element defining an inner cavity and an outer surface, wherein the outer surface is positioned radially outward from the inner cavity and comprises one or more engagement members configured to secure the mounting element to a crimping device; and an implant alignment device comprising a support portion and a coupling portion, wherein the support portion is configured to support a prosthetic implant on a distal end portion and extend at least partially within a central channel of the crimping device, and wherein at least a portion of the implant alignment device is slidably positioned within the inner cavity of the mounting element, such that the implant alignment device is slidable relative to the mounting element.

23. An assembly for crimping a prosthetic implant on a delivery apparatus, the assembly comprising: a crimping device comprising a central channel, a first side portion, and a second side portion, wherein the central channel extends from the first side portion to the second side portion; an alignment guide configured to couple to the first side portion of the crimping device, the alignment guide configured to receive a portion of a delivery apparatus such that a target crimping location of a distal end portion of the delivery apparatus is positioned within the central channel of the crimping device; and an implant alignment device configured to be at least partially and slidably positioned within an inner cavity of the alignment guide, the implant alignment device configured toAttorney Docket No: THVMC-23892WO01 position a prosthetic implant around the target crimping location of the distal end portion of the delivery apparatus and within the central channel of the crimping device.

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