Prosthetic valve preparation assemblies and associated methods

Abstract

Prosthetic valve preparation assemblies and associated methods are disclosed herein. A crimper assembly may include a first crimp stop and a second crimp stop that define respective ranges of motion of an actuator handle. A method of mounting an implantable prosthetic valve to a valve delivery device may include inserting a balloon catheter within the implantable prosthetic valve, partially curling an annular frame of the implantable prosthetic valve, positioning a curled alignment tool in an aligned configuration relative to the valve delivery device, and positioning the curled alignment tool in a non-aligned configuration relative to the valve delivery device. The implantable prosthetic valve is positioned to engage the curl alignment tool, and the annular frame is fully curled.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 368,632, filed on July 15, 2022, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates to prosthetic valve preparation assemblies and associated methods, and more particularly to assemblies and methods utilizing apparatus for crimping an implantable prosthetic valve onto a delivery device. Background Art

[0004] The human heart may suffer from various valvular diseases. These valvular diseases may cause significant dysfunction of the heart, and ultimately require repairing the natural valve or replacing the natural valve with an artificial valve. There are many known repair devices (e.g., stents) and artificial valves, as well as many known methods for implanting these devices and valves into the human body. Percutaneous and minimally invasive surgical methods are used in various surgeries to deliver prosthetic medical devices to a position that is not easily accessible by surgery or a position that is expected to be accessible without surgery. In a specific example, a prosthetic heart valve can be mounted on the distal end of a delivery device in a curled state, and advanced through the patient's vascular system (e.g., through the femoral artery and aorta) until the prosthetic heart valve reaches the implantation site in the heart. Subsequently, for example, by inflating a balloon on which a prosthetic valve is mounted, a mechanical actuator that applies an expansion force to the prosthetic heart valve is actuated, or by deploying the prosthetic heart valve from the sheath of the delivery device so that the prosthetic heart valve can self-expand to its functional size, the prosthetic heart valve is expanded to its functional size. Summary of the invention

[0005] Disclosed herein are prosthetic valve preparation assemblies including a crimper assembly, a valve delivery assembly, an implantable prosthetic valve, and a crimp alignment tool, and associated methods. The disclosed prosthetic valve preparation assemblies and methods can, for example, ensure that an implantable prosthetic valve is crimped to a valve delivery device at a desired position.

[0006] The crimper assembly may include an actuator handle, a second crimping stop, and a first crimping stop. The actuator handle is configured to be manually actuated to crimp an implantable prosthetic valve around a valve delivery device. The valve delivery device may include a handle and one or more shafts coupled to the handle. The second crimping stop defines a full range of motion of the actuator handle, and the first crimping stop defines a portion of the range of motion of the actuator handle. The first crimping stop is configured to selectively and operably couple to the second crimping stop.

[0007] In a representative example, the crimper assembly further comprises: a base; a housing fixedly mounted to the base and defining a crimper assembly central axis; and a plurality of circumferentially arranged nested jaws supported within the housing. The jaws are radially movable within the housing toward and away from the central axis. The plurality of jaws collectively define a crimper aperture, the diameter of the crimper aperture varying as the jaws move toward and away from the central axis.

[0008] In some examples, the actuator handle is movable relative to the housing to move the jaws toward and away from the central axis.

[0009] In some examples, when the first crimp stop is operably coupled to the second crimp stop, actuating the actuator handle to engage the first crimp stop operates to bring the crimper aperture to a first stop diameter.

[0010] In some examples, when the first crimp stop is removed from the second crimp stop, actuating the actuator handle to engage the second crimp stop operates to bring the crimper aperture to a second stop diameter that is less than the first stop diameter.

[0011] In some examples, the crimper assembly includes one or more of the components described in Examples 1-14 and / or 25-43 below.

[0012] A method for mounting an implantable prosthetic valve to a valve delivery device may include inserting a balloon catheter of the valve delivery device into a central passage of a frame of the implantable prosthetic valve, partially curling the annular frame of the implantable prosthetic valve with a crimper assembly, and fully curling the annular frame of the implantable prosthetic valve.

[0013] In some examples, a method further includes operably coupling a crimping alignment tool to a distal portion of the valve delivery device to position the crimping alignment tool in an aligned configuration relative to the valve delivery device, and positioning the implantable prosthetic valve to engage the crimping alignment tool.

[0014] In some instances, the crimper assembly includes an actuator handle configured to be manually actuated to curl the implantable prosthetic valve around the valve delivery device, a second crimp stop that limits an entire range of motion of the actuator handle, and a first crimp stop that limits a portion of the range of motion of the actuator handle and is configured to be selectively and operably coupled to the second crimp stop.

[0015] In some examples, partially curling the annular frame includes actuating the actuator handle to engage the first curl stop with the first curl stop operably coupled to the second curl stop.

[0016] In some examples, fully curling the annular frame includes actuating the actuator handle to engage the second curl stop.

[0017] In some examples, the method further includes removing the first curl stop from the second curl stop after the partially curling the annular frame and before the fully curling the annular frame.

[0018] In some examples, the method comprises one or more of the steps described in Examples 19-24 below.

[0019] The various innovations of the present disclosure may be used in combination or alone. The present disclosure is provided to introduce a series of concepts further described in the following detailed description in a simplified form. The present disclosure is not intended to identify the 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 present disclosure will become more apparent from the following detailed description, claims and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is a perspective view illustrating components of a prosthetic valve preparation assembly according to one example.

[0021] Figure 2 is a detailed perspective view of an example of a crimp alignment tool and balloon cover assembly mounted on a valve delivery device.

[0022] Figure 3 yes Figure 2 Exploded view of the crimp alignment tool, balloon cover assembly, and valve delivery device of the invention.

[0023] Figure 4 is a partial perspective view showing the crimp alignment tool mounted on a valve delivery device and the balloon cover assembly removed from the valve delivery device.

[0024] Figure 5A is an isometric view of a pair of balloon cover flap portions in an assembled configuration.

[0025] Figure 5B yes Figure 5A A side view of one of the flap portions of the balloon cover.

[0026] Figure 5C yes Figure 5AAn isometric view of one of the flap sections of the balloon cover.

[0027] Figure 5D yes Figure 5A Another isometric view of the flap portion of the balloon cover.

[0028] Fig. 6A is an isometric view of the crimp alignment tool.

[0029] Figure 6B yes Fig. 6A Another isometric view of the curl alignment tool.

[0030] Figure 6C yes Fig. 6A A plan view of the crimp alignment tool.

[0031] Fig.6D It is like Figure 6C The line in 6D-6D is observed Fig. 6A Cross-sectional view of the crimp alignment tool.

[0032] Figure 7 is a side view of a curl stop assembly according to one example.

[0033] Fig. 8A yes Figure 7 A side view of a first curl stop of a curl stop assembly.

[0034] Figure 8B yes Fig. 8A Isometric view of the first curl stop.

[0035] Figure 8C yes Fig. 8A Another isometric view of the first curl stop.

[0036] Fig. 9A yes Figure 7 A side view of a second curl stop of the curl stop assembly.

[0037] Fig. 9B yes Fig. 9A Isometric view of the second curl stop.

[0038] Fig. 9C yes Fig. 9A Another isometric view of the second curl stop.

[0039] Fig.10 is a side view of another example of a curl stop assembly.

[0040] Fig.11 is a perspective view of an example of an implantable prosthetic valve.

[0041] Fig.12is a perspective view of an example of an implantable prosthetic valve in an operational configuration and positioned on an example of a valve delivery device.

[0042] Fig.13 is located in the crimper assembly Fig.12 Perspective view of an implantable prosthetic valve and valve delivery device.

[0043] Fig.14 yes Fig.13 A perspective view of an implantable prosthetic valve, a valve delivery device, and a crimper assembly, wherein an actuator handle of the crimper assembly engages a first crimp stop of the crimper assembly.

[0044] Fig.15 yes Fig.12 A perspective view of an implantable prosthetic valve and a valve delivery device of FIG. 1 , wherein the implantable prosthetic valve is in an intermediate configuration and engages an example of a crimp alignment tool.

[0045] Fig.16 yes Fig.15 A perspective view of an implantable prosthetic valve, valve delivery device, and crimper assembly of Fig.13 An actuator handle of the crimper assembly engages a second crimp stop of the crimper assembly.

[0046] Fig.17 yes Fig.12 A perspective view of an implantable prosthetic valve and a valve delivery device of FIG. 1 , wherein the implantable prosthetic valve is in a delivery configuration.

[0047] Fig.18 yes Fig.17 A perspective view of an implantable prosthetic valve and a valve delivery device with a stylet of the valve delivery device removed.

[0048] Fig.19 is a flow chart depicting an example of a method of mounting an implantable prosthetic valve to a valve delivery device. DETAILED DESCRIPTION

[0049] General considerations

[0050] For the purposes of this specification, certain aspects, advantages, and novel features of examples of the present disclosure are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any way. Instead, the present disclosure relates to all novel and non-obvious features and aspects of the various disclosed examples, individually and in various combinations and sub-combinations with each other. The methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, nor do the disclosed examples require the presence of any one or more specific advantages or solutions to problems.

[0051] Although the operations of some of the disclosed examples are described in a particular sequential order for ease of presentation, it should be understood that this manner of description encompasses repetitions unless the specific language set forth below requires a particular order. For example, in some cases, the operations described in sequence may be repeated or performed simultaneously. In addition, for the sake of simplicity, the accompanying drawings may not show the various ways in which the disclosed methods may be used in conjunction with other methods. In addition, this specification sometimes uses terms such as "providing" or "implementing" to describe the disclosed methods. These terms are high-level abstractions of the actual operations performed. The actual operations corresponding to these terms may vary depending on the specific implementation and are easily discernible by a person of ordinary skill in the art.

[0052] 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 "include" means "comprise." Further, the term "coupled" generally means physical, mechanical, chemical, magnetic, and / or electrical coupling or connection, and does not exclude the presence of intervening elements between coupled or associated items absent specific language to the contrary.

[0053] As used herein, the term "proximal" refers to a device that is closer to the user and further away from the location, direction or part of the implantation site. As used herein, the term "distal" refers to a device that is further away from the user and closer to the location, direction or part of the implantation site. Therefore, for example, the proximal movement of the device is the movement of the device away from the implantation site and toward the user (e.g., leaving the patient's body), and the distal movement of the device is the movement of the device away from the user and toward the implantation site (e.g., entering the patient's body). Unless otherwise clearly defined, the terms "longitudinal" and "axial" refer to the axis extending in the proximal and distal directions. Further, the term "radial" refers to a direction perpendicular to the axis arrangement and pointing from the center of the object along the radius (wherein the axis is positioned at the center, such as the central longitudinal axis of the delivery assembly).

[0054] As used herein, "such as" means "for example," and "ie" means "that is to say."

[0055] Introduction of public technology

[0056] Various systems, devices, methods, etc. are disclosed herein, including prosthetic valve preparation assemblies that can be used in conjunction with implantable prosthetic valves, such as transcatheter heart valves (THVs). The various systems, devices, methods, etc. disclosed herein generally relate to preparing implantable prosthetic valves for delivery through a patient's vasculature to a target implantation site. Specifically, the present disclosure relates to instances in which an implantable prosthetic valve includes an annular frame that can be crimped to a contracted diameter for passage through a patient's vasculature and subsequently expanded to an operating diameter by an inflatable balloon of a valve delivery device.

[0057] Prior to curling, a balloon-expandable implantable prosthetic valve is typically placed over an expandable balloon on a catheter shaft. In the case where the valve is manufactured at its fully curled diameter, the valve is expanded and then curled onto the balloon. In order to ensure that the balloon reliably expands the frame of the valve after the valve reaches the target implantation site in the patient's vasculature, it may be beneficial to ensure that the curling process causes the valve to curl onto the balloon at a repeatable and precise position. It is also beneficial to ensure that the curling process curls the frame of the valve uniformly and does not damage the valve, while ensuring that the curled diameter of the valve is small enough to traverse the patient's vasculature. The present disclosure addresses these needs.

[0058] The present disclosure is generally directed to examples of implantable valve preparation assemblies and examples of methods of preparing an implantable prosthetic valve for delivery to a target implantation site utilizing various components of the prosthetic valve preparation assemblies.

[0059] like Figure 1 As shown, and as discussed in more detail below, the prosthetic valve preparation assembly 10 can include an implantable prosthetic valve 300, a valve delivery device 200 configured to deliver the implantable prosthetic valve 300 to a target implantation site, and a crimper assembly 100 for crimping the implantable prosthetic valve around the valve delivery device.

[0060] Also like Figure 1 As shown, and as discussed in more detail below, the prosthetic valve preparation assembly 10 can further include a curling alignment tool 400 configured to facilitate curling of the implantable prosthetic valve at a target curling position relative to the valve delivery device 200, and / or a balloon cover assembly 450 configured to selectively engage the valve delivery device 200 and / or the curling alignment tool 400.

[0061] Exemplary Implantable Prosthetic Valve

[0062] Various prosthetic valves are described and / or discussed herein. Although specific examples of prosthetic heart valves are discussed herein, the general structure, methods of manufacture, and methods of use of various implantable prosthetic valves that may be suitable for use with the apparatus 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 each of which are incorporated herein by reference in their entirety.

[0063] The prosthetic valve disclosed herein can be radially compressed and expanded between a radially compressed state and a radially expanded state. Thus, during delivery, the prosthetic valve can be crimped on or held by an implant delivery device in a radially compressed state, and then once the prosthetic valve reaches the implantation site, the prosthetic valve is expanded to a radially expanded state. It should be understood that the prosthetic valve disclosed herein can be used with a variety of implant delivery devices and can be implanted via a variety of delivery procedures, examples of which will be discussed in more detail later.

[0064] Figure 1 , 11 -12, 15 and 17-18 show examples of implantable prosthetic valves 300. As used herein, implantable prosthetic valves 300 may also be referred to as prosthetic valves 300, valves 300 and / or transcatheter heart valves (THV) 300. Any of the prosthetic valves disclosed herein are suitable for implantation in the native aortic valve annulus, but in other examples, the prosthetic valves may be suitable for implantation in other native valve annuli of the heart (pulmonary valve, mitral valve and tricuspid valve). The disclosed prosthetic valves may also be implanted in blood vessels connected to the heart, including the patient's pulmonary artery (to replace the function of a diseased pulmonary valve, or the superior vena cava or inferior vena cava (to replace the function of a diseased tricuspid valve) or various other veins, arteries and blood vessels. The disclosed prosthetic valves may also be implanted in a previously implanted prosthetic valve (which may be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0065] In some examples, the disclosed prosthetic valve can be implanted in a docking or anchoring device implanted in a natural heart valve or blood vessel. For example, in one example, the disclosed prosthetic valve can be implanted in a docking device implanted in the pulmonary artery to replace the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another example, the disclosed prosthetic valve can be implanted in a docking device implanted in or at a natural mitral valve, such as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In another example, the disclosed prosthetic valve can be implanted in a docking device implanted in the superior vena cava or the inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed in U.S. Patent Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0066] like Fig.11 As shown in FIG. 1 , the implantable prosthetic valve 300 includes an annular frame 310 defining a frame central passage 314 and a valve assembly 320 positioned within the frame central passage 314. The annular frame 310 is radially expandable and contractible so that the implantable prosthetic valve 300 can be placed in a delivery configuration (see, e.g., FIG. 1 ). Figure 17-18 ) and operational configuration (see e.g. Figure 11-12 ). Specifically, when in the delivery configuration, the diameter of implantable prosthetic valve 300 is reduced sufficiently to be sized for delivery through the patient's vasculature. When in the operational configuration, implantable prosthetic valve 300 is expanded in diameter so as to be operably mounted at a target implantation site and to allow valve assembly 320 to operate to regulate blood flow in the patient. However, it should be understood that implantable prosthetic valve 300 may be described as being in the operational configuration even when implantable prosthetic valve 300 is not positioned within a patient and / or at a target implantation site.

[0067] The frame 310 can be made of any of various suitable plastic expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol) known in the art. When constructed of plastic expandable materials, the frame 310 (and therefore the valve 300) can be curled into a radially compressed state on the delivery catheter and then expanded in the patient's body by an inflatable balloon or an equivalent expansion mechanism. When constructed of self-expandable materials, the frame 310 (and therefore the valve 300) can be curled into a radially compressed state and limited to a compressed state by being inserted into a sheath or an equivalent mechanism of the delivery catheter. Once in the body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0068] Suitable plastic expandable materials that can be used to form the frames disclosed herein (e.g., frame 310) include metal alloys, polymers, or combinations thereof. Example metal alloys can include one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some instances, frame 310 can include stainless steel. In some instances, frame 310 can include cobalt-chromium alloy. In some instances, frame 310 can include nickel-cobalt-chromium. In some instances, frame 310 includes a nickel-cobalt-chromium-molybdenum alloy, such as MP35N. TM (trade name of SPS Technologies), which is equivalent to UNSR30035 (covered by ASTM F562-02). MP35N TM / UNS R30035 contains 35 wt% nickel, 35 wt% cobalt, 20 wt% chromium and 10 wt% molybdenum.

[0069] Examples of Valve Delivery Devices

[0070] Described herein are examples of steerable delivery devices (sometimes referred to as steerable catheters and / or valve delivery assemblies) that can be used to guide the vasculature of a subject to deliver an implantable, expandable medical device (e.g., a prosthetic heart valve), tool, medicament, or other therapy to a location in the subject's body. Examples of procedures for which steerable catheters are applicable include neurological, urological, gynecological, fertility (e.g., in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures that include access to any body duct or cavity. Specific examples include placement of implants, including stents, grafts, embolization coils, etc.; positioning of imaging devices and / or components thereof, including ultrasonic transducers; and positioning of energy sources, RF sources, ultrasonic transmitters, electromagnetic sources, laser sources, heat sources, etc., such as for performing lithotripsy.

[0071] According to an example, a valve delivery assembly and / or components thereof are Figure 1-4 Although specific examples of valve delivery assemblies are discussed herein, the general structure and methods of use of various valve delivery assemblies that may be suitable for use with the devices and methods disclosed herein are described in at least U.S. Pat. Nos. 9,061,119 and 9,339,384, the disclosures of which are incorporated herein by reference in their entireties.

[0072] At least Figure 1-3 As shown in FIG. 1 , the valve delivery device 200 may include a steerable guide catheter 210 and a balloon catheter 220 extending through the guide catheter 210 (in FIG. 1 ). Figure 1 and Figure 3As used herein, guide catheter 210 may also be referred to as flexible catheter 210 and / or main catheter 210. However, use of the term "main catheter" should be understood to include flexible or guide catheters, as well as other catheters that are not flexible or guideable through the patient's vasculature.

[0073] In some embodiments, such as in the illustrated embodiment, guide catheter 210 and balloon catheter 220 are adapted to slide longitudinally relative to one another to facilitate delivery and positioning of implantable prosthetic valve 300 at a target implantation site within a patient's body.

[0074] like Figure 1 As shown, guide catheter 210 includes a handle portion 212 and an elongated guide catheter shaft or tube 214 extending from handle portion 212. Balloon catheter 220 includes a proximal portion 222 adjacent to handle portion 212 and a balloon catheter shaft 226 extending from proximal portion 222 and through handle portion 212 and guide catheter shaft 214.

[0075] In some instances, and at least as Figure 3 , the balloon catheter shaft 226 can be an outer balloon catheter shaft 226, and the balloon catheter 220 can additionally include an inner balloon catheter shaft 228, which extends from the proximal portion 222 and coaxially passes through the outer balloon catheter shaft 226 and the inflatable balloon 230. In such examples, the balloon catheter 220 can include a fluid passage, which is fluidly connected to the annular space defined between the inner balloon catheter shaft 228 and the outer balloon catheter shaft 226. Specifically, such a fluid passage can be fluidically connected to a fluid source for inflating the inflatable balloon so as to convert the implantable prosthetic valve 300 from a delivery configuration to an operational configuration. In the present disclosure, the operational configuration can also be referred to as a radially expanded configuration of the implantable prosthetic valve 300 and / or the annular frame 310.

[0076] Continue to refer Figure 1 and Figure 3 , the valve delivery device 200 additionally includes an inflatable balloon 230 mounted on the balloon catheter 220 at a distal portion 224 of the balloon catheter 220 opposite the proximal portion 222. As discussed in more detail herein, the valve delivery device 200 is generally configured such that an implantable prosthetic valve 300 is mounted to the valve delivery device 200 in a crimped state to prepare the valve delivery device 200 and the implantable prosthetic valve 300 for insertion into the vasculature of a patient.

[0077] In some examples of valve delivery assemblies for delivering implantable prosthetic valves, the valve delivery device is configured to crimp the implantable prosthetic valve to a position adjacent to but removed from an inflatable balloon. Such a configuration can facilitate crimping the implantable prosthetic valve to a relatively small profile, thereby facilitating delivery of the implantable prosthetic valve through the patient's vasculature. Use of such a system typically requires a separate step of repositioning the implantable prosthetic valve on the inflatable balloon within the patient's vasculature.

[0078] In contrast, mounting an implantable prosthetic valve directly onto an inflatable balloon prior to entering the patient's vasculature can improve the reliability and ease of implanting the implantable prosthetic valve at a target implantation site. Thus, the apparatus and methods disclosed herein can be used to crimp an implantable prosthetic valve 300 on an inflatable balloon 230 relative to a valve delivery apparatus 200 in a tightly compressed profile and at a precise target crimping position.

[0079] In some instances, and at least as Figure 3 , the valve delivery device 200 includes a nose component 240 mounted at the distal end of the valve delivery device 200 to facilitate advancement of the valve delivery device 200 through the patient's vasculature to a target implantation site. In some cases, it may be useful to connect the nose component 240 to a separate elongated shaft so that the nose component 240 can move independently of the other elements of the valve delivery device 200. The nose component 240 can be formed from any of a variety of materials, including various polymers, metals, and / or composite materials.

[0080] In some instances, and at least as Figure 3 As shown in , the valve delivery device 200 further includes a stylet 250 configured to be removably coupled to the distal end of the nasal component 240. More specifically, and as shown in Figure 3 As shown in , the nasal component 240 can include a nasal component lumen 242, and the stylet 250 can include a stylet shaft 252 (e.g., a rigid and / or metal shaft) that is configured to be received within the nasal component lumen 242 to selectively couple the stylet 250 to the nasal component 240.

[0081] In some instances, the stylet 250 is more rigid than the nasal component 240. Specifically, the nasal component 240 can be formed of a material that is sufficiently elastic and / or compliant to enable the nasal component 240 to traverse the patient's vasculature without damaging the patient's vasculature. That is, the valve delivery device 200 can be configured such that the nasal component 240 defines the distal end or tip of the valve delivery device 200 as the valve delivery device 200 advances through the patient's vasculature. However, as described in more detail herein, operably coupling the nasal component 240 to the relatively rigid stylet 250 prior to introducing the valve delivery device 200 into the patient's vasculature can facilitate reliably positioning the implantable prosthetic valve 300 at a target crimping position on the inflatable balloon 230.

[0082] As used herein, the term "operably 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 each other in a manner consistent with the structure and / or functionality disclosed herein. For example, a pair of components may be described as being operably coupled to each other when such components are operably coupled to each other to produce the structural configuration and / or functional properties disclosed herein.

[0083] Examples of delivery technologies

[0084] In order to implant the prosthetic valve in the native aortic valve by the transfemoral delivery method, the prosthetic valve is installed along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral artery and advanced into and through the descending aorta, around the aortic arch and through the ascending aorta. The prosthetic valve is positioned in the native aortic valve and radially expanded (e.g., by inflating the balloon, actuating one or more actuators of the delivery device, or deploying the prosthetic valve from the sheath to allow the prosthetic valve to self-expand). Alternatively, the prosthetic valve can be implanted in the native aortic valve in a transapical surgery, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through the surgical opening in the chest and the apex, and the prosthetic valve is positioned in the native aortic valve. Alternatively, in a transaortic procedure, the prosthetic valve (on the distal portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, through a partial J-shaped sternotomy or a right parasternal mini-thoracotomy, and is then advanced through the ascending aorta toward the native aortic valve.

[0085] To implant a prosthetic valve into the native mitral valve via a transseptal delivery method, the prosthetic valve is mounted in a radially compressed state along the distal portion of the delivery device. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and advanced into and through the inferior vena cava, into the right atrium, through the atrial septum (through a perforation made in the atrial septum), into the left atrium, and advanced toward the native mitral valve. Alternatively, the prosthetic valve can be implanted into the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and apex of the heart, and the prosthetic valve is positioned within the native mitral valve.

[0086] To implant the prosthetic valve into the native tricuspid valve, the prosthetic valve is installed along the distal portion of the delivery device in a radially compressed state. The prosthetic valve and the distal portion of the delivery device are inserted into the femoral vein and 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 method can be used to implant the prosthetic valve into the native pulmonary valve or 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.

[0087] Another delivery method is a transatrial approach, in which the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision made through the atrial wall (of the right or left atrium) to access any native heart valve. Atrial delivery can also be performed intravascularly, such as from the pulmonary veins. Yet another delivery method is a transventricular approach, in which the prosthetic valve (on the distal portion of the delivery device) is inserted through an incision in the chest and through an incision made through the wall of the right ventricle (usually at or near the base of the heart) to implant the prosthetic valve into the native tricuspid valve, native pulmonary valve, or pulmonary artery.

[0088] In all delivery methods, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery methods are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of a variety of delivery procedures and delivery devices known in the art.

[0089] Examples of Crimper Assemblies

[0090] As discussed herein, the prosthetic valve preparation assembly 10 generally includes a crimper assembly 100 for crimping an implantable prosthetic valve 300 onto an inflatable balloon 230. The crimper assembly and / or components thereof according to some examples are provided in Figure 1 , 7-10, 13-14 and 16. Although specific examples of crimper assemblies are discussed herein, the general structure and methods of use of various crimper assemblies that may be suitable for use with the apparatus and methods disclosed herein are described in at least U.S. Patent No. 7,530,253, the disclosure of which is incorporated herein by reference in its entirety.

[0091] If at least Figure 1 and Fig.13 As shown in FIG. 1 , the crimper assembly 100 may include a base 112, a housing 110 fixedly mounted to the base 112, and a plurality of circumferentially arranged nested jaws 114 (in Figure 1 ), the plurality of circumferentially arranged nested jaws are supported within a housing 110. More specifically, the housing 110 defines a crimper assembly central axis 102, and the jaws 114 are radially movable within the housing 110 toward and away from the crimper assembly central axis 102. The jaws 114 collectively define a crimper orifice 130, the diameter of which changes as the jaws 114 move toward and away from the crimper assembly central axis 102.

[0092] The crimper assembly 100 further includes an actuator handle 120 that is configured to be manually actuated to move the jaws 114 to change the diameter of the crimper orifice 130. Specifically, in the illustrated example, the actuator handle 120 can be pivoted relative to the housing 110 in a first direction to move the jaws 114 radially toward the crimper assembly central axis 102, and the actuator handle 120 can be pivoted relative to the housing 110 in a second direction opposite to the first direction to move the jaws 114 radially away from the crimper assembly central axis 102. Thus, when the implantable prosthetic valve 300 is positioned within the crimper orifice 130, actuating the actuator handle 120 to reduce the diameter of the crimper orifice 130 can operate to crimp the implantable prosthetic valve 300.

[0093] In some examples, the crimper orifice 130 extends along a crimper orifice length, as measured along a direction parallel to the crimper assembly central axis 102, that is equal to or greater than the valve length 302 ( 102 ) of the implantable prosthetic valve 300. Fig.12 ). Thus, in such examples, implantable prosthetic valve 300 can be positioned completely within crimper orifice 130 such that crimper assembly 100 applies the crimping force uniformly across the entire length of implantable prosthetic valve 300.

[0094] When crimper assembly 100 is used to fully crimp implantable prosthetic valve 300 to the delivery configuration, implantable prosthetic valve 300 may engage inflatable balloon 230 sufficiently tightly so that implantable prosthetic valve 300 is restricted from translating relative to inflatable balloon 230. Therefore, before fully crimping implantable prosthetic valve 300 on inflatable balloon 230, it is desirable to ensure that implantable prosthetic valve 300 is properly positioned at the target crimped position.

[0095] As used herein, the term "target crimp position" is intended to refer to any suitable axial position and / or range of positions along the inflatable balloon 230 to which the implantable prosthetic valve 300 will be operably coupled. For example, the target crimp position may include and / or may be the axial position along the inflatable balloon 230 at which the distal end of the implantable prosthetic valve 300 is located when the implantable prosthetic valve 300 is properly crimped to the inflatable balloon 230. As another example, the target crimp position may include and / or may be the axial position along the inflatable balloon 230 at which the proximal end of the implantable prosthetic valve 300 is located when the implantable prosthetic valve 300 is properly crimped to the inflatable balloon 230. As yet another example, the target crimp position may refer to a portion (e.g., a spacing) of the length of the inflatable balloon 230 within which the implantable prosthetic valve 300 is positioned when the implantable prosthetic valve 300 is properly crimped to the inflatable balloon 230.

[0096] Positioning the implantable prosthetic valve 300 at a target crimped position with high precision and / or accuracy can facilitate predictable deployment of the implantable prosthetic valve 300 at a target implantation site. Specifically, in some instances, positioning the implantable prosthetic valve 300 at a target implantation site is performed by positioning one or more components of the valve delivery device 200 at a known, measurable, and / or controlled position and / or orientation relative to the patient's anatomy. Therefore, in such instances, controlling the position of the implantable prosthetic valve 300 relative to the delivery device 200 with high precision and / or accuracy can facilitate controlling the position and / or orientation of the implantable prosthetic valve 300 relative to the target implantation site.

[0097] Additionally, in some instances, the shape of implantable prosthetic valve 300 after radial expansion by inflatable balloon 230 is sensitive to the position at which implantable prosthetic valve 300 is crimped onto inflatable balloon 230. Thus, in such instances, controlling the position of implantable prosthetic valve 300 relative to delivery device 200 (e.g., relative to inflatable balloon 230) with a high degree of precision and / or accuracy can be advantageous in ensuring that implantable prosthetic valve 300 assumes the intended shape when radially expanded by inflatable balloon 230 to an operative configuration at a target implantation site.

[0098] The devices and methods disclosed herein can facilitate and / or enable the implantable prosthetic valve 300 to be crimped at a target crimping position with any suitable precision and / or accuracy. Specifically, in some examples, the devices and methods disclosed herein can consistently produce a crimping accuracy of approximately 1.0-1.5 millimeters (mm) relative to the target crimping position. In some such examples, the target crimping position corresponds to a distinct location and / or feature of the valve delivery device 200, such as a portion of the nose component 240 and / or a distal portion of the balloon catheter 220.

[0099] When implantable prosthetic valve 300 is in the operational configuration and positioned near the target crimped position, the diameter of frame central passageway 314 can be large enough so that implantable prosthetic valve 300 only loosely and / or tangentially engages valve delivery apparatus 200. Thus, even if implantable prosthetic valve 300 in the operational configuration is properly positioned at the target crimped position prior to fully crimping implantable prosthetic valve 300, the crimping action (and / or axial translation of valve delivery apparatus 200 during the crimping action) can displace implantable prosthetic valve 300 to a position away from the target crimped position.

[0100] Thus, it may be desirable to partially crimp implantable prosthetic valve 300 to an intermediate configuration prior to fully crimping implantable prosthetic valve 300 to a delivery configuration. Specifically, in such instances, the size (e.g., inner diameter) of implantable prosthetic valve 300 in the intermediate configuration may be configured to engage valve delivery device 200 and / or inflatable balloon 230 such that implantable prosthetic valve 300 may be manually translated relative to inflatable balloon 230, but such that accidental translation of implantable prosthetic valve 300 relative to inflatable balloon 230 is at least partially limited. In this manner, crimping implantable prosthetic valve 300 to an intermediate configuration and then positioning implantable prosthetic valve 300 at a target crimped position may ensure that implantable prosthetic valve 300 remains at the target crimped position during a final crimping maneuver.

[0101] In some examples, crimping implantable prosthetic valve 300 to an intermediate or delivery configuration is accomplished by bringing the diameter of crimper orifice 130 to a corresponding predetermined diameter. This in turn can be accomplished by mechanically limiting the range of motion of actuator handle 120 during use of crimper assembly 100.

[0102] More specifically, and as Figure 1 , 7 -10, 13-14 and 16, and as discussed in more detail below, the crimper assembly 100 can include a first crimp stop 150 (an example of which is shown in Figure 1 , 7-8C, 10 and 13-14) and a second curl stop 170 (shown in Figure 1 , 7 , 9A-10, 13-14 and 16), each of the curling stops can be used to limit a respective range of motion of the actuator handle 120. The second curling stop 170 can be fixedly coupled relative to the housing 110 during use of the crimper assembly 100, and the first curling stop 150 can be selectively and operably coupled to the second curling stop 170. Specifically, and as described in more detail herein, the first curling stop 150 is configured to be mechanically coupled to the second curling stop 170.

[0103] In some examples, the first crimp stopper 150 and the second crimp stopper 170 may be described as representing components of the crimp stopper assembly 140 of the crimper assembly 100. Specifically, Figure 1 , Figure 7 -8c and Figure 13-14 A first example of a curl stop assembly 140a is shown, the curl stop assembly comprising a first example of a combination of a first curl stop 150a and a second curl stop 170, and Fig.10 A second example of a curl stop assembly 140b is shown, which includes a second example of a combination of a first curl stop 150b and a second curl stop 170.

[0104] In the present disclosure, and unless otherwise specified (e.g., with reference to a specific illustrated example), references to the curl stop assembly 140 may be understood as relating to and / or referring to either or both of the first example curl stop assembly 140a and / or the second example curl stop assembly 140b. Similarly, in the present disclosure, and unless otherwise specified (e.g., with reference to a specific illustrated example), references to the first curl stop 150 may be understood as relating to and / or referring to either or both of the first example first curl stop 150a and / or the second example first curl stop 150b. Thus, in the present disclosure, like numerals are used to refer to like components of the various examples of the curl stop assembly 140 and / or the first curl stop 150, but each such numeral may not be specifically discussed and / or explicitly referenced herein.

[0105] When the first crimp stop 150 is operably coupled to the second crimp stop 170, the first crimp stop 150 and the second crimp stop 170 together can define a portion of the range of motion of the actuator handle 120. That is, when the first crimp stop 150 is operably coupled to the second crimp stop 170, the actuator handle 120 can be actuated to reduce the diameter of the crimper aperture 130 until the actuator handle 120 engages the first crimp stop 150, at which point further actuation of the actuator handle 120 in that direction is mechanically limited and / or prevented.

[0106] Fig.14 An implantable prosthetic valve 300 and a valve delivery device 200 (in Fig.14 1 (not visible in the figure) is positioned within the crimper aperture 130 and wherein the actuator handle 120 is actuated to engage the first crimp stop 150. Fig.14 As shown, when actuator handle 120 engages first crimp stop 150, crimper orifice 130 can be described as having a first stop diameter 132 that corresponds to an intermediate configuration of implantable prosthetic valve 300. That is, when implantable prosthetic valve 300 is positioned within crimper orifice 130 and actuator handle 120 engages first crimp stop 150, implantable prosthetic valve 300 crimps to the intermediate configuration due to crimper orifice 130 reaching first stop diameter 132. Thus, when the implantable prosthetic valve is in the intermediate configuration, the outer diameter of implantable prosthetic valve 300 can be at least substantially equal to first stop diameter 132.

[0107] When the first crimp stop 150 is removed from the second crimp stop 170, the second crimp stop 170 can limit the overall range of motion of the actuator handle 120. That is, when the first crimp stop 150 is removed from the second crimp stop 170, and when the second crimp stop 170 is fixedly coupled relative to the housing 110, the actuator handle 120 can be actuated to reduce the diameter of the crimper aperture 130 until the actuator handle 120 engages the second crimp stop 170, at which point further actuation of the actuator handle 120 in that direction is mechanically limited and / or prevented.

[0108] Fig.16 An implantable prosthetic valve 300 and a valve delivery device 200 (in Fig.16 130 and wherein the actuator handle 120 is actuated to engage the second crimp stop 170. Fig.16170, when actuator handle 120 engages the second crimp stop, crimper orifice 130 can be described as having a second stop diameter 134 that corresponds to the delivery configuration of implantable prosthetic valve 300 and is smaller than first stop diameter 132. That is, when implantable prosthetic valve 300 is positioned within crimper orifice 130 and actuator handle 120 engages second crimp stop 170, implantable prosthetic valve 300 crimps to the delivery configuration due to crimper orifice 130 reaching second stop diameter 134. Thus, when the implantable prosthetic valve is in the delivery configuration, the outer diameter of implantable prosthetic valve 300 can be at least substantially equal to second stop diameter 134.

[0109] In examples disclosed herein, first crimp stop 150 may be used during an initial step of crimping crimper assembly 100 for crimping implantable prosthetic valve 300, and / or second crimp stop 170 may be used during a final step of crimping crimper assembly 100 for crimping implantable prosthetic valve 300. Thus, in such examples, first crimp stop 150 may additionally or alternatively be referred to as an initial crimp stop 150, and / or second crimp stop 170 may additionally or alternatively be referred to as a final crimp stop 170. Similarly, in such examples, first stop diameter 132 may additionally or alternatively be referred to as an initial stop diameter 132, and / or second stop diameter 134 may additionally or alternatively be referred to as a final stop diameter 134. However, such examples are not limiting, and the curl stop assembly 140 may include additional curl stops, such as a third curl stop, a fourth curl stop, etc., which are further within the scope of the present disclosure. In such examples, multiple curl stops (and / or subsets thereof) may be coupled to each other in various combinations to define a respective range of motion of the actuator handle 120 and / or to produce a respective diameter of the crimper aperture 130.

[0110] The first curl stop 150 and the second curl stop 170 may each have any of a variety of features and / or configurations for exhibiting the functionality disclosed herein. Figures 8A-8C A first example of a first curl stop 150a is shown, and Figures 9A-9C An example of a second curl stop 170 is shown. Figure 7 Demonstrates operable connection to Figures 9A-9C The second curling stopper 170 Figures 8A-8C The first curling stopper 150a of Fig.10 Demonstrates operable connection to Figures 9A-9C The second curl stopper 170 is another example of the first curl stopper 150b.

[0111] In some instances, and at least as Figure 7-8C As shown, the first curl stopper 150 includes a first curl stopper body 158 (eg, Figure 7-8C 1 , the first crimp stop body 158a) is shown in the crimp assembly 100, which defines and terminates at the first crimp stop end 160. In such examples, the crimper assembly 100 is configured so that the actuator handle 120 engages the first crimp stop end 160 during use of the crimper assembly 100 to partially crimp the implantable prosthetic valve 300.

[0112] Similarly, in some instances, and at least as Figure 7 and 9A -9C, the second crimp stop 170 includes a second crimp stop body 172 that defines and terminates at a first crimp stop end 174. In such examples, the crimper assembly 100 is configured such that the actuator handle 120 engages the second crimp stop end 174 during use of the crimper assembly 100 to fully crimp the implantable prosthetic valve 300.

[0113] Additionally, the first curl stop 150 and / or the second curl stop 170 may have any of a variety of features to facilitate operably coupling the first curl stop 150 to the second curl stop 170. For example, in some examples, and as Figure 7-8C As shown, the first curling stopper 150 includes a second curling stopper container 154 (e.g., Figure 7-8C The second curl stop receptacle 154a shown in FIG. 1 is configured to receive a portion of the second curl stop 170, such as the second curl stop body 172 and / or the second curl stop end 174, when the first curl stop 150 is operably coupled to the second curl stop 170. As a more specific example, the second curl stop receptacle 154 may include and / or be a receptacle channel 156 (e.g., Figure 7-8C The receptacle channel 156a shown in FIG. 1 receives the elongated portion of the second curl stop 170 to mechanically couple the first curl stop 150 to the second curl stop 170 .

[0114] In some examples, the internal geometry of the first crimp stop 150 (e.g., the receptacle channel 156) is configured to accommodate a top portion (e.g., a portion including the second crimp stop end 174) of the second crimp stop 170 in a mating configuration. For example, the receptacle channel 156 may be shaped similarly to the top portion of the second crimp stop 170 so that the first crimp stop 150 may snap onto the second crimp stop 170. Such mechanical engagement may also be used to prevent accidental removal of the first crimp stop 150 from the second crimp stop 170.

[0115] Additionally or alternatively, in some instances, such as in Figure 7-8C In the example of the first curl stop 150, the first curl stop 150 includes a gripping feature 152 (e.g., Figure 7-8C 150 ), the gripping feature 152a being configured to facilitate removal of the first curl stop 150 from the second curl stop 170. Specifically, when present, the gripping feature 152 can be configured to be gripped by a user to apply torque on the first curl stop 150 and / or to enable the user to pull the first curl stop 150 away from the second curl stop 170. The gripping feature 152 can include and / or be any of a variety of structures, examples of which include tabs, levers, protrusions, notches, etc. In some examples, the gripping feature 152 is at least partially defined by the first curl stop body 158.

[0116] Fig.10 The second example of the first curl stop 150b shown in FIG. 1 is substantially similar to Figure 7-8C , except that the first crimp stop body 158b additionally defines an upper recess 159 connected to (eg, open to) the receptacle passage 156b. Specifically, and as shown Fig.10 As shown, when the first crimp stop 150b is coupled to the second crimp stop 170, the second crimp stop body 172 occupies the receptacle channel 156b but not the upper recess 159, which in turn is positioned between the first crimp stop end 160b and the second crimp stop end 174. Such a configuration can facilitate flexing of the first crimp stop body 158b, such as when the gripping feature 152b is pulled and / or torque is applied thereto to remove the first crimp stop 150b from the second crimp stop 170.

[0117] As discussed above, the crimper assembly 100 is generally configured such that during use of the crimper assembly 100, the second crimp stop 170 is fixedly coupled relative to the housing 110. Specifically, as shown in FIG. Fig.13As shown, during use of the crimper assembly 100 , the second crimp stop 170 may be coupled to the base 112 and / or the housing 110 at a crimp stop attachment location 118 defined by the base 112 and / or the housing 110 .

[0118] In some examples, the base 112 and / or the housing 110 can include a curl stop receptacle 116 that defines a curl stop attachment location 118. In such examples, the curl stop receptacle 116 can include and / or be any suitable structure and / or mechanism for fixedly retaining the second curl stop 170, examples of which include friction fit couplings, snap fit couplings, latch couplings, keyed couplings, and the like.

[0119] In some examples, the second curl stop 170 may be permanently or semi-permanently attached to the curl stop attachment location 118. In other words, in such examples, the second curl stop 170 may not be configured to be removed from the curl stop attachment location 118 without damaging the crimper assembly 100. However, this is not required for all examples of the crimper assembly 100, and it is otherwise within the scope of the present disclosure that the second curl stop 170 may be configured to be selectively and / or temporarily attached to the curl stop attachment location 118. In other words, in some examples, the second curl stop 170 may be configured to be selectively and repeatedly coupled to and removed from the curl stop attachment location 118 without damaging the crimper assembly 100.

[0120] Example of a curl alignment tool

[0121] As discussed above, it is generally desirable to ensure that implantable prosthetic valve 300 is accurately and reliably positioned at a target crimped position relative to inflatable balloon 230 before fully crimping implantable prosthetic valve 300 onto inflatable balloon 230. Therefore, and at least as Figure 2-4 , 6A-6D, and 15, the prosthetic valve preparation assembly 10 can include a crimp alignment tool 400 configured to facilitate positioning the implantable prosthetic valve 300 at a target crimp position.

[0122] The crimp alignment tool 400 can be used to ensure that the implantable prosthetic valve 300 is positioned at a predetermined axial position relative to one or more components of the valve delivery device 200 that correspond to a target crimp position. Specifically, and as discussed in more detail herein, the crimp alignment tool 400 can be configured to engage each of the valve delivery device 200 and the implantable prosthetic valve 300 to position the implantable prosthetic valve 300 at the target crimp position relative to the valve delivery device 200.

[0123] As discussed above, when implantable prosthetic valve 300 is in an intermediate configuration (e.g., after being partially crimped by crimper assembly 100), implantable prosthetic valve 300 may be manually translated along the length of valve delivery apparatus 200 and / or inflatable balloon 230, but may otherwise be restricted from inadvertent translation relative to valve delivery apparatus 200. Thus, in some examples, crimp alignment tool 400 is used to position implantable prosthetic valve 300 when implantable prosthetic valve 300 is in an intermediate configuration.

[0124] The crimp alignment tool 400 can have any of a variety of properties and / or features for engaging the valve delivery device 200 and / or the implantable prosthetic valve 300. In some examples, and at least as Figure 3 , 6B 6D , the crimp alignment tool 400 includes a catheter receptacle 440 configured to receive a distal portion of the valve delivery device 200. Specifically, the crimp alignment tool 400 is configured such that when the distal portion of the valve delivery device 200 is operably received within the catheter receptacle 440 (as described herein), the crimp alignment tool 400 can be described as being in an aligned configuration relative to the valve delivery device 200.

[0125] The alignment configuration of the crimping alignment tool 400 may be described and / or defined with reference to the relative orientation and / or mechanical engagement between the crimping alignment tool 400 and the valve delivery device 200. Specifically, and as described in greater detail herein, the crimping alignment tool 400 may include a crimping alignment tool distal end 420 configured to engage a distal portion of the valve delivery device 200 to define an alignment configuration and / or to maintain the crimping alignment tool 400 in an alignment configuration.

[0126] When the crimp alignment tool 400 is in the aligned configuration relative to the valve delivery device 200, the position of the crimp alignment tool 400 can be used to place the implantable prosthetic valve 300 at the target crimp position. Figure 3 , 6A -6D and 15, the crimp alignment tool 400 includes a valve stopper 412 positioned in a proximal region 410 of the crimp alignment tool 400.

[0127] like Fig.15As shown, valve stopper 412 is configured to engage distal frame end 312 of annular frame 310 of implantable prosthetic valve 300. Specifically, crimp alignment tool 400 is configured such that when crimp alignment tool 400 is in an aligned configuration with crimp alignment tool distal end 420 engaging a distal portion of valve delivery device 200, implantable prosthetic valve 300 is positioned such that distal frame end 312 engages valve stopper 412 to operate to position implantable prosthetic valve 300 at a target crimp position. As discussed in more detail below, valve stopper 412 may include and / or be a structure defined by crimp alignment tool 400, such as an annular surface and / or terminal edge thereof.

[0128] The crimping alignment tool 400 can be configured to engage the valve delivery device 200 in the aligned configuration in any of a variety of ways. In some examples, the crimping alignment tool 400 can be moved longitudinally (e.g., by axial translation) onto the distal portion of the valve delivery device 200 to operably couple the crimping alignment tool 400 to the valve delivery device 200. Similarly, in such examples, the crimping alignment tool 400 can be removed from the valve delivery device 200 by sliding the crimping alignment tool 400 longitudinally off and away from the valve delivery device 200.

[0129] In some examples, the crimp alignment tool 400 can be configured to limit and / or prevent accidental removal of the crimp alignment tool 400 from the valve delivery device 200. For example, the crimp alignment tool 400 can be configured such that when the crimp alignment tool 400 is in the aligned configuration, removal of the crimp alignment tool 400 from the valve delivery device 200 is at least partially limited. As a more specific example, the crimp alignment tool 400 can be configured to engage a distal portion of the valve delivery device with a friction fit engagement, a mechanical engagement, a latch engagement, a snap fit engagement, etc.

[0130] In some examples, positioning the crimp alignment tool 400 in the aligned configuration may produce a tactile and / or audible confirmation, such as a snap, a pop, a bump, etc., indicating that the crimp alignment tool has reached the aligned configuration. Such tactile and / or audible confirmation may be, for example, the result of a mechanical coupling being formed, such as an engaging latch, an engaging / receiving detent, an engaging / receiving protrusion or groove, etc.

[0131] The crimp alignment tool 400 can be configured to receive and / or engage any suitable portion of the valve delivery device 200 for defining and / or maintaining the crimp alignment tool 400 in an aligned configuration. Figure 2 , 415, the crimp alignment tool 400 is configured such that when the crimp alignment tool 400 is in the aligned configuration, the stylet 250 of the valve delivery device 200 engages the crimp alignment tool distal end 420. In such examples, the crimp alignment tool 400 can be configured such that when the crimp alignment tool 400 is in the aligned configuration, the inner diameter of the crimp alignment tool 400 mates with the outer diameter of the stylet 250.

[0132] In particular, and as discussed above, the stylet 250 can be formed of a more rigid material than the nose piece 240, and thus can provide a reliable reference point for measuring an axial distance relative to the inflatable balloon 230. For example, when the stylet 250 is formed of a relatively rigid material, such rigidity can facilitate establishing a precise and / or well-defined positional relationship between the stylet 250 and the crimp alignment tool 400.

[0133] More specifically, in some examples, the stylet shaft 252 extends within the nasal component lumen 242 to engage a relatively rigid component of the valve delivery device 200, such as the distal end of the balloon catheter 220. Thus, in such examples, when the stylet 250 is operably coupled to the nasal component 240, an axial force applied to the stylet 250 can be transmitted to the balloon catheter 220 via the stylet shaft 252. Because the axial position of the distal end of the balloon catheter 220 is substantially fixed relative to the inflatable balloon 230 (and therefore relative to the target crimping position), the stylet 250 itself can be used as a reference position for locating the target crimping position. That is, the size of the stylet 250 and / or the stylet shaft 252 can be set so that when the stylet shaft 252 engages the distal end of the balloon catheter 220 through the nose piece lumen 242, and when the crimp alignment tool 400 receives and engages the stylet 250, the valve stop 412 is aligned with the target crimping position (and / or its distal end). In this way, such a configuration can facilitate establishing a precise and substantially constant axial positional relationship between the crimp alignment tool 400 and the target crimping position, thereby ensuring that the crimp alignment tool 400 can be used to properly position the implantable prosthetic valve 300.

[0134] In some instances, and at least as Figure 4 As shown in FIG. 4 , the crimp alignment tool distal end 420 includes a distal orifice 422 that receives a distal portion of the valve delivery apparatus 200 (eg, the stylet 250 ) when the crimp alignment tool is in the aligned configuration.

[0135] Specifically, in some such examples, crimp alignment tool 400 can be configured such that when crimp alignment tool 400 is in the aligned configuration, stylet 250 at least partially extends through distal aperture 422. In this manner, engagement between distal aperture 422 and stylet 250 can at least partially define the aligned configuration.

[0136] For example, the shape of the guide needle 250 can be at least partially conical, so that the guide needle 250 engages the distal orifice 422 (i.e., the portion of the curling alignment tool 400 that defines the distal orifice 422) only when the guide needle 250 is in a precise and predetermined axial position relative to the curling alignment tool 400.

[0137] In some examples, the crimp alignment tool 400 can include a distal alignment indicator 424 in the form of one or more features for providing visual verification that the crimp alignment tool 400 is in an aligned configuration. For example, in some examples, and as Figure 2-4 , 6A-6D, and 15, the distal alignment indicator 424 includes a window 426 that allows for visual inspection of the valve delivery device 200 through the crimp alignment tool 400. That is, in such examples, the window 426 can be an opening and / or aperture formed in a sidewall of the crimp alignment tool 400 such that a portion of the valve delivery device 200 housed within the crimp alignment tool 400 is visible through the window 426.

[0138] In some examples, the crimp alignment tool 400 is configured such that when the crimp alignment tool is in the aligned configuration, components of the valve delivery device are axially aligned with the distal edge of the window 426 and / or with the proximal edge of the window 426. Specifically, in some examples, and at least in Fig.15 , the window 426 is positioned so that when the crimp alignment tool 400 is in the aligned configuration, the proximal edge of the stylet 250 is axially aligned with the distal edge of the window 426. In this way, the user can verify that the crimp alignment tool 400 is in the aligned configuration by visually verifying that the proximal edge of the stylet 250 is axially aligned with the distal edge of the window 426.

[0139] Additionally or alternatively, in some instances, and as Figure 6C, the distal alignment indicator 424 can include one or more visual indicia 428 that provide another visual indicator that the crimp alignment tool 400 is in the aligned configuration. For example, the visual indicia 428 can be configured such that when the crimp alignment tool 400 is in the aligned configuration, components of the valve delivery device 200 (e.g., the nose piece 240 and / or the stylet 250) are axially aligned with the visual indicia 428. As an example, the visual indicia 428 can include and / or can be a mark, a colored mark, a printed mark, an embossed mark, a debossed mark, a line, a symbol, etc.

[0140] The crimp alignment tool 400 can be configured to engage the implantable prosthetic valve 300 to position the implantable prosthetic valve 300 at a target crimp position in any suitable manner. Figures 6A-6C , the crimp alignment tool 400 includes and / or terminates at a crimp alignment tool proximal end 414 that defines a valve stop 412. In other words, in such examples, positioning the implantable prosthetic valve 300 such that the distal frame end 312 engages and / or abuts the crimp alignment tool proximal end 414 when the crimp alignment tool 400 is in the aligned configuration operates to position the implantable prosthetic valve at a target crimp position.

[0141] However, this is not required for all embodiments of the crimp alignment tool. For example, it is also within the scope of the present disclosure that the crimp alignment tool 400 is configured to at least partially axially overlap the implantable prosthetic valve 300 to position the implantable prosthetic valve 300 at the target crimp position. As a more specific example, and as Fig.6D As schematically shown in FIG. 4 , the curling alignment tool 400 may include a stepped inner surface that defines a valve stop 412 in the form of an annular shoulder or protrusion such that when the distal frame end 312 engages the valve stop 412 , the implantable prosthetic valve 300 is partially received within the curling alignment tool 400 .

[0142] Example of a balloon cover assembly

[0143] In some examples, the prosthetic valve preparation assembly 10 can additionally include one or more features for maintaining the shape and / or configuration of the valve delivery device 200 and / or crimp alignment tool 400 prior to crimping the implantable prosthetic valve 300 onto the inflatable balloon 230. For example, in some examples, and as Figure 2-5D, the prosthetic valve preparation assembly 10 includes a balloon cover assembly 450 that is configured to be operably coupled to the inflatable balloon 230 so as to shape and / or protect the inflatable balloon 230 prior to preparing the valve delivery device 200 to be deployed in the vasculature of a patient. More specifically, and as described in greater detail herein, the balloon cover assembly 450 can be configured to cover and / or engage the inflatable balloon 230 so as to protect the inflatable balloon 230 from damage or deformation when shipped to a user.

[0144] In some instances, and as Figure 2-5D As shown in , the balloon cover assembly 450 can include a pair of balloon cover flap portions 460a and 460b, which are configured to be mounted to opposite sides of the inflatable balloon 230 when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230. Specifically, Figure 2 The balloon cover flap portions 460a and 460b are shown operably coupled to the inflatable balloon 230, and Figure 3-4 The balloon cover flap portions 460a and 460b are shown removed from the inflatable balloon 230. As discussed below, Figures 5A-5C The balloon cover flap portion 460a and / or 460b are shown in more detail. In the present disclosure, the balloon cover flap portion 460a may also be referred to as the first balloon cover flap portion 460a, and / or the balloon cover flap portion 460b may also be referred to as the second balloon cover flap portion 460b.

[0145] The balloon cover flap portions 460a and 460b may collectively engage the inflatable balloon 230 to hold the balloon cover assembly 450 in position relative to the inflatable balloon 230 and / or to maintain the shape of the inflatable balloon 230. As used herein, each of the balloon cover flap portions 460a and 460b may be described as representing a respective instance of the balloon cover flap portion 460.

[0146] In some examples, the balloon cover assembly 450 additionally includes one or more features to limit the removal of the balloon cover flap portions 460a and 460b from the inflatable balloon 230. Specifically, in some examples, and as Figure 2-3, the balloon cover assembly 450 includes a balloon cover sleeve 452 that is configured to surround the balloon cover flap portions 460a and 460b and retain the balloon cover flap portions 460a and 460b relative to the inflatable balloon 230. In other words, when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230, and when the balloon cover flap portions 460a and 460b are received within the balloon cover sleeve 452, the balloon cover sleeve 452 can restrict and / or prevent the balloon cover flap portions 460a and 460b from being removed from the inflatable balloon 230 until the balloon cover sleeve 452 is removed from the balloon cover flap portions 460a and 460b.

[0147] In some instances, and with specific reference to Figure 2-3 5A, when operably coupled to the inflatable balloon 230, the balloon cover flap portions 460a and 460b together form a cylindrical outer surface, and the balloon cover sleeve 452 (at Figure 3 460a and 460b. In this way, in this example, the balloon cover sleeve 452 can be installed on and removed from the balloon cover flap portions 460a and 460b by sliding the balloon cover sleeve 452 longitudinally onto and away from the balloon cover flap portions.

[0148] However, such a configuration is not required, and any suitable form for the balloon cover sleeve 452 to engage the balloon cover flap portions 460a and 460b is otherwise within the scope of the present disclosure. For example, the balloon cover flap portions 460a and 460b and the balloon cover sleeve 452 may include corresponding mating surfaces that engage each other (e.g., via a friction interface and / or mechanical coupling) to limit accidental removal of the balloon cover sleeve 452 from the balloon cover flap portions 460a and 460b.

[0149] Each of the balloon cover flap portions 460a and 460b can be configured to engage the inflatable balloon 230 in any of a variety of ways. In some examples, and at least as Figure 5C-5D, each of the balloon cover flap portions 460a and / or 460b can include a respective proximal balloon engagement surface 462a or 462b (respectively) that engages the inflatable balloon 230 when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230. Specifically, the engagement between the proximal balloon engagement surface 462 and the inflatable balloon 230 can facilitate establishing and / or maintaining a formed geometry of the inflatable balloon 230. Additionally or alternatively, the engagement between the proximal balloon engagement surfaces 462a and 462b and the inflatable balloon 230 can limit axial translation of the balloon cover flap portion 460 relative to the inflatable balloon 230 when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230.

[0150] Each of the proximal balloon engagement surfaces 462a and 462b can include and / or be any of a variety of structural features for engaging the inflatable balloon 230. For example, and at least as Figure 5C-5D As shown in , each of the proximal balloon engagement surfaces 462a and / or 462b can include and / or be one or more locking ribs 464 that extend radially toward and / or engage the inflatable balloon 230 when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230. More specifically, in the example shown, the proximal balloon engagement surface 462a includes four locking ribs 464a, while the proximal balloon engagement surface 462b includes three locking ribs 464b that are staggered relative to the locking ribs 464a. Thus, when the balloon cover flap portions 460a and 460b are assembled to each other, the locking ribs 464a and 464b are staggered with each other.

[0151] In some examples, the proximal balloon engagement surfaces 462a and 462b can be configured to engage with each other when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230. As a more specific example, when each of the proximal balloon engagement surfaces 462a and 462b includes a corresponding locking rib 464a and 464b, the locking rib 464a can be configured to interlace with the locking rib 464b and frictionally engage the locking rib, thereby limiting the removal of the balloon cover flap portions 460a and 460b from each other. In other words, in such examples, the proximal balloon engagement surfaces 462a and 462b are configured to engage with each other when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230 to mechanically hold the balloon cover flap portions 460a and 460b against each other.

[0152] As discussed above, the balloon cover flap portion 460a / 460b and / or its proximal balloon engagement surface 462a / 462b can engage the inflatable balloon 230 to facilitate establishing and / or maintaining the geometric shape of the inflatable balloon 230. Specifically, the engagement between the proximal balloon engagement surface 462a / 462b and the inflatable balloon 230 can operate to slightly compress and / or mechanically shape the inflatable balloon 230 (e.g., the proximal portion 232 of the inflatable balloon 230, e.g., Figure 3-4 shown).

[0153] Additionally or alternatively, such engagement can operate to form the inflatable balloon 230 into a reduced radius profile (e.g., relative to a profile prior to operably coupling the balloon cover assembly 450 to the inflatable balloon 230), which profile can persist upon removal of the balloon cover flap portions 460a / 460b from the inflatable balloon 230. Such a retracted profile can facilitate ensuring that the final profile of the inflatable balloon 230 (e.g., after utilizing the crimper assembly 100 as disclosed herein) is small enough to extend within the inner diameter of the guide catheter shaft 214.

[0154] In some examples, a pair of balloon cover flap portions 460a and 460b are at least substantially similar and / or identical to each other. Figures 5A-5D In the example of , the balloon cover flap portions 460a and 460b are identical to each other except for the configuration and number of locking ribs 464 of each corresponding proximal balloon engagement surface 462a / 462b. Specifically, the balloon cover flap portion 460a ( Figure 5C ) includes a proximal balloon engagement surface 462a having four locking ribs 464, and a balloon cover flap portion 460b ( Figure 5D ) includes a proximal balloon engagement surface 462b having three locking ribs 464.

[0155] Although the present disclosure is generally directed to examples in which the balloon cover assembly 450 includes a pair of balloon cover flap portions 460 (e.g., balloon cover flap portions 460a and 460b), this is not required for all examples of the balloon cover assembly 450. For example, the balloon cover assembly 450 may include any suitable number of balloon cover flap portions 460 for engaging the inflatable balloon 230 as described herein, such as three balloon cover flap portions 460, four balloon cover flap portions 460, or more than four balloon cover flap portions 460 are otherwise within the scope of the present disclosure.

[0156] In some instances, and at least as Figure 2 and 5A, a pair of balloon cover flap portions 460 are configured to engage with each other when the balloon cover assembly is operably coupled to the inflatable balloon 230. More specifically, a pair of balloon cover flap portions 460 can be configured to abut and / or cooperate with each other.

[0157] However, this is not required for all instances of the balloon cover assembly 450 , and it is otherwise within the scope of the present disclosure that the balloon cover flap portions 460 may be spaced apart from one another when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230 .

[0158] In some examples, the balloon cover assembly 450 can additionally or alternatively be configured to engage the crimp alignment tool 400 when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230. For example, the balloon cover assembly 450 can be configured to engage the crimp alignment tool 400 such that when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230, and when the crimp alignment tool 400 is in the aligned configuration, the balloon cover assembly 450 restricts removal of the crimp alignment tool 400 from the valve delivery device 200.

[0159] As a more specific example, and at least in Figure 3 , the crimp alignment tool 400 may include a flap engagement feature 430, and each balloon cover flap portion 460 may include a crimp alignment tool engagement feature 470, which engages the flap engagement feature 430 when the balloon cover assembly 450 is operably engaged with the crimp alignment tool 400.

[0160] The flap engagement feature 430 and the crimp alignment tool engagement feature 470 may include and / or be any suitable features, such as features that cooperate with each other and / or mechanically engage with each other to limit and / or prevent axial translation of the crimp alignment tool 400 relative to the balloon cover assembly 450. As a more specific example, and as Figure 3 As shown in , the flap engagement feature 430 may include an annular groove 432, and each crimp alignment tool engagement feature 470 may include an engagement tooth 472. Specifically, Figure 3 The engaging teeth 472b of the second balloon cover flap portion 460b are marked, and Figure 4 The engagement teeth 472a of the first balloon cover flap portion 460a are more clearly shown.

[0161] like Figure 4, each engagement tooth 472a and 472b can extend radially inwardly so that when the balloon cover assembly 450 is operably engaged with the crimp alignment tool 400, each engagement tooth extends within the annular groove 432. Therefore, in such examples, when the balloon cover assembly 450 is operably engaged with the crimp alignment tool 400, each engagement tooth 472 is received within a portion of the annular groove 432 to limit axial translation of the crimp alignment tool 400 relative to the balloon cover assembly 450.

[0162] In this way, in the illustrated example, each curling alignment tool engagement feature 470 can be described as a convex mating feature, and the flip cover engagement feature 430 can be described as a concave mating feature. However, this is not required for all examples of the balloon cover assembly and / or the curling alignment tool. For example, each curling alignment tool engagement feature 470 can additionally or alternatively include and / or be a concave mating feature (e.g., a groove, a channel, a slot, a recess, a notch, etc.) and is also within the scope of the present disclosure. Similarly, the flip cover engagement feature 430 can additionally or alternatively include and / or be a convex mating feature (e.g., a tooth, a protrusion, a ridge, etc.) and is also within the scope of the present disclosure.

[0163] Exemplary Methods

[0164] Now go to Fig.19 The present disclosure provides a method of mounting an implantable prosthetic valve to a valve delivery device for delivering the implantable prosthetic valve to a target implantation site within a patient's vasculature. The method may be performed in conjunction with any suitable components of the prosthetic valve preparation assembly 10 disclosed herein. Therefore, in the present disclosure, any description of components, features, characteristics, configurations, etc. presented with reference to steps of the method may be understood as a reference to any of the components, features, characteristics, configurations, etc., presented herein with reference to the prosthetic valve preparation assembly 10 and / or reference to the method. Figure 1-18 Reference to any corresponding (e.g., similarly named) components, features, characteristics, configurations, etc. disclosed.

[0165] like Fig.19 As shown, at 510, method 500 can include inserting a balloon catheter of a valve delivery device into a central passage of a frame of an implantable prosthetic valve. For example, inserting the balloon catheter into the central passage of the frame at 510 can include longitudinally sliding the implantable prosthetic valve onto a distal portion of the valve delivery device so as to position the implantable prosthetic valve around and / or adjacent to the inflatable balloon.

[0166] Fig.12 An example may be described showing the configuration of an implantable prosthetic valve and valve delivery device after inserting a balloon catheter within a central passage of a frame at 510 .

[0167] In some examples, and as discussed above, the valve delivery device can include a balloon cover assembly having a pair of balloon cover flap portions and a balloon cover sleeve. In some such examples, the method 500 can be initiated and / or at least partially performed when the balloon cover assembly is operably coupled to the inflatable balloon. Thus, in some examples, the method 500 additionally includes removing the balloon cover assembly from the inflatable balloon prior to inserting the balloon catheter into the central passage of the frame at 510.

[0168] In some such examples, removing the balloon cover assembly includes removing the balloon cover sleeve from the pair of balloon cover flap portions (e.g., by sliding the balloon cover sleeve axially away from and away from the balloon cover flap portions). After removing the balloon cover assembly, the method may include removing the pair of balloon cover flap portions from the inflatable balloon.

[0169] At 520, method 500 can include partially crimping the annular frame of the implantable prosthetic valve with a crimper assembly. As discussed herein, the crimper assembly can be used to partially crimp the annular frame of the implantable prosthetic valve to bring the implantable prosthetic valve to an intermediate configuration in which the implantable prosthetic valve can be selectively but intentionally positioned along the valve delivery device.

[0170] As discussed herein, partially crimping the annular frame at 520 may include radially compressing the implantable prosthetic valve to bring the annular frame to a diameter at least substantially equal to a first stop diameter, as may be defined by a diameter of a crimper orifice.

[0171] In some examples, partially crimping the annular frame at 520 includes directly engaging the implantable prosthetic valve with jaws of the crimper assembly.

[0172] As disclosed herein, the crimper assembly can include a first crimping stop and a second crimping stop that individually or collectively define a range of motion of an actuator handle of the crimper assembly. Specifically, partially crimping the annular frame at 520 can include actuating the actuator handle when the second crimping stop is fixedly coupled relative to a housing of the crimper assembly and when the first crimping stop is operably coupled to the second crimping stop. Thus, in some examples, the method 500 additionally includes operably coupling the first crimping stop to the second crimping stop, such as by inserting the second crimping stop into a second crimping stop receptacle of the first crimping stop, prior to partially crimping the annular frame at 520.

[0173] With the first crimp stop operably coupled to the second crimp stop, partially crimping the annular frame at 520 may include positioning the implantable prosthetic valve within a crimper orifice of the crimper assembly (e.g., as shown in FIG. Fig.13 ), and actuating the actuator handle to engage the first curl stop (e.g., as Fig.14 shown).

[0174] Specifically, in some examples, the implantable prosthetic valve is positioned within the crimper orifice such that the entire valve length of the implantable prosthetic valve is contained within the crimper orifice length of the crimper orifice. Thus, partially crimping the annular frame at 520 may include uniformly radially compressing the annular frame over its entire length.

[0175] At 530, method 500 can include operably coupling a crimp alignment tool to a distal portion of the valve delivery device to position the crimp alignment tool in an aligned configuration relative to the valve delivery device. Specifically, and as described in greater detail herein, when the crimp alignment tool is in the aligned configuration, the crimp alignment tool can be used to determine and / or establish a target crimp position of the implantable prosthetic valve on the inflatable balloon.

[0176] In some examples, operably coupling the crimp alignment tool at 530 includes engaging the distal portion of the valve delivery device with the crimp alignment tool to position the crimp alignment tool in an aligned configuration. This can be accomplished in any suitable manner, such as by receiving the distal portion of the valve delivery device within the crimp alignment tool such that the stylet of the valve delivery device extends partially within a distal orifice of the crimp alignment tool.

[0177] In various examples, operably coupling the crimp alignment tool to the valve delivery device at 530 can be performed before or after partially crimping the annular frame at 520 . Fig.15 An example may be described showing the configuration of an implantable prosthetic valve and valve delivery apparatus after partially crimping the annular frame at 520 and after operably coupling a crimp alignment tool at 530 .

[0178] In some examples, operably coupling the crimping alignment tool at 530 may additionally or alternatively include axially advancing the crimping alignment tool toward the inflatable balloon until further axial advancement of the crimping alignment tool is limited (eg, due to a stylet engaging a distal end of the crimping alignment tool).

[0179] In some examples, operably coupling the crimp alignment tool at 530 includes visually verifying that the crimp alignment tool has reached the aligned configuration. For example, and as described above, the crimp alignment tool can include a distal alignment indicator configured to provide a visual indication that the crimp alignment tool is in the aligned configuration. Thus, in some examples, method 500 can include visually verifying the axial position of the valve delivery device relative to the distal alignment indicator.

[0180] As a more specific example, in some instances, visually verifying the axial position of the valve delivery device includes visually verifying that a component of the valve delivery device (e.g., a proximal edge of a stylet) is axially aligned with a proximal edge or a distal edge of a window defined in a crimp alignment tool, such as, for example Fig.15 as shown in .

[0181] Additionally or alternatively, verifying the axial position of the valve delivery device can include verifying that components of the valve delivery device are axially aligned with one or more visual indicia of the crimp alignment tool, as discussed above.

[0182] At 540, method 500 can include positioning the implantable prosthetic valve to engage the crimp alignment tool. For example, positioning the implantable valve to engage the crimp alignment tool at 540 can include axially translating the implantable prosthetic valve relative to the valve delivery device such that the distal frame end of the annular frame engages a valve stop of the crimp alignment tool.

[0183] In some examples, positioning the implantable prosthetic valve to engage the crimp alignment tool at 540 is performed after partially crimping the annular frame at 520. Specifically, when the implantable prosthetic valve is positioned to engage the crimp alignment tool when in the intermediate configuration, the implantable prosthetic valve can be maintained at a substantially fixed axial position relative to the inflatable balloon while the implantable prosthetic valve is fully crimped onto the inflatable balloon.

[0184] In other words, in such examples, positioning the implantable prosthetic valve to engage the crimping alignment tool at 540 is performed with the implantable prosthetic valve in an intermediate configuration in which the implantable prosthetic valve is substantially fixed in position relative to the inflatable balloon until intentionally repositioned. In this way, partially crimping the annular frame to transition the implantable prosthetic valve to the intermediate configuration can facilitate positioning the implantable prosthetic valve to engage the crimping alignment tool such that the implantable prosthetic valve remains in position relative to the crimping alignment tool during a subsequent crimping step, as discussed below.

[0185] Fig.15Further may be described as illustrating an example of configuration of an implantable prosthetic valve and valve delivery apparatus after partially crimping the annular frame at 520, after operably coupling a crimp alignment tool at 530, and after positioning the implantable prosthetic valve at 540.

[0186] At 550, method 500 can include fully crimping the annular frame of the implantable prosthetic valve. As discussed herein, a crimper assembly can be used to fully crimp the annular frame of the implantable prosthetic valve to bring the implantable prosthetic valve to a delivery configuration. When the implantable prosthetic valve is in the delivery configuration, the annular frame of the implantable prosthetic valve contracts to a diameter at least substantially equal to a second stop diameter that is less than the first stop diameter. In some examples, fully crimping the annular frame at 550 includes directly engaging the implantable prosthetic valve with the jaws of the crimper assembly.

[0187] As discussed herein, fully crimping the annular frame at 550 can include actuating the actuator handle while the second crimp stop is fixedly coupled relative to the housing of the crimper assembly, but while removing the first crimp stop from the second crimp stop. Thus, in some examples, method 500 additionally includes removing the first crimp stop from the second crimp stop before fully crimping the annular frame at 550.

[0188] In some examples, removing the first curl stop from the second curl stop can include grasping a gripping feature of the initial curl top to pivot the first curl stop relative to the second curl stop and / or pulling the first curl stop away from the second curl stop.

[0189] With the first curl stopper removed from the second curl stopper, and as Fig.16 As shown, fully crimping the annular frame at 550 can include positioning the implantable prosthetic valve within the crimper orifice of the crimper assembly and actuating the actuator handle to engage the second crimp stop.

[0190] Specifically, in some examples, the implantable prosthetic valve is positioned within the crimper orifice such that the entire valve length of the implantable prosthetic valve is contained within the crimper orifice length of the crimper orifice. Thus, fully crimping the annular frame at 550 may include uniformly radially compressing the annular frame over its entire length.

[0191] In some instances, actuating the actuator handle once to engage the second crimp stop may not be sufficient to maintain the implantable prosthetic valve in the delivery configuration after the jaws of the crimper assembly are released from the implantable prosthetic valve. For example, the annular frame of the implantable prosthetic valve at 550 may be sufficiently stiff and / or resilient such that after the annular frame is compressed to the second stop diameter by crimping the annular frame, the annular frame expands slightly to a diameter greater than the second stop diameter after the jaws are released.

[0192] Thus, in some examples, method 500 further includes, after actuating the actuator handle to engage the second crimp stop, actuating the actuator handle to release the jaws of the crimper assembly from the implantable prosthetic valve, and repeatedly actuating the actuator handle to engage the second crimp stop. In other words, in such examples, fully crimping the annular frame at 550 includes repeatedly crimping the implantable prosthetic valve with the crimper assembly to ensure that the annular frame remains at a diameter substantially equal to the diameter of the second stop after the jaws are released from the annular frame. In such examples, fully crimping the annular frame at 550 can include contacting the actuator handle with the second crimp stop any suitable number of times, examples of which include at least two times, at least three times, at least four times, and / or at most five times.

[0193] With the implantable prosthetic valve fully crimped on the inflatable balloon and in the delivery configuration, the valve delivery device can be prepared for insertion into the vasculature of the patient, except that the various components associated with method 500 can remain coupled to the valve delivery device.

[0194] Thus, in some examples, method 500 additionally includes removing the crimp alignment tool from the valve delivery device and / or removing the stylet of the valve delivery device from the nasal component. Fig.17 can be described as showing the configuration of the implantable prosthetic valve and valve delivery device at 550 after the annular frame has been fully crimped and the stylet is still coupled to the nasal component, while Fig.18 It can be described as showing these components after the stylet is removed from the nose piece. Additionally, Fig.18 The guide catheter is shown relative to Fig.17 The configuration is advanced in a distal direction such that the guide catheter extends proximate to the fully crimped implantable prosthetic valve.

[0195] Specifically, and with reference to Figure 17-18 In an example, completely crimping the implantable prosthetic valve 300 onto the inflatable balloon 230 may result in the proximal portion 232 of the inflatable balloon 230 being uncovered (eg, Fig.17To prepare valve delivery device 200 for advancement through the patient's vasculature, proximal portion 232 of inflatable balloon 230 may be covered by advancing guide catheter shaft 214 distally to abut and / or engage implantable prosthetic valve 300 (e.g., Fig.18 shown).

[0196] As discussed above, various components and / or features of the prosthetic valve preparation assembly 10 can be configured to facilitate advancement of the guide catheter shaft 214 over the proximal portion 232 of the inflatable balloon 230. For example, and as discussed above, the engagement between the proximal balloon engagement surfaces 462a / 462b and the inflatable balloon 230 can operate to slightly compress and / or mechanically shape the proximal portion 232 of the inflatable balloon 230 into a profile that is appropriately contracted to allow the proximal portion 232 to extend within the inner diameter of the guide catheter shaft 214.

[0197] Any of the systems, devices, equipment, etc. herein can be sterilized (e.g., with heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure that it is safe for use by patients, and as a step in the steps of the method, any method in the method herein can include the sterilization of the associated systems, devices, equipment, etc. The example of heating / thermal sterilization includes steam sterilization and autoclave sterilization. Examples of radiation for sterilization include, but are not limited to, gamma radiation, ultraviolet radiation, and electron beams. Examples of chemicals for sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. For example, the sterilization carried out with hydrogen peroxide can be completed using hydrogen peroxide plasma.

[0198] Additional Embodiments of the Disclosed Technology

[0199] In view of the above-mentioned embodiments of the disclosed subject matter, the present application discloses the additional embodiments listed below. It should be noted that a feature of a separate embodiment or more than one feature of an embodiment adopted in combination, and optionally combined with one or more features of one or more further embodiments, is a further embodiment that also falls within the disclosure of the present application.

[0200] Example 1. A prosthetic valve preparation assembly, comprising: an implantable prosthetic valve, the implantable prosthetic valve comprising an annular frame defining a central passage of the frame and a valve assembly positioned within the central passage of the frame; a valve delivery device, the valve delivery device being configured to deliver the implantable prosthetic valve to a target implantation site through the vascular system of a patient; a crimper assembly, the crimper assembly being used to crimp the implantable prosthetic valve around the valve delivery device, wherein the crimper assembly comprises: an actuator handle, the actuator handle being configured to be manually actuated to crimp the implantable prosthetic valve around the valve delivery device; a second crimping stopper, the second crimping stopper limiting the actuator handle; a curling alignment tool configured to facilitate curling of the implantable prosthetic valve relative to the inflatable balloon of the valve delivery device; wherein the curling alignment tool is configured to engage the implantable prosthetic valve to position the implantable prosthetic valve at a target curling position relative to the valve delivery device, and wherein the curling alignment tool is configured to slide longitudinally onto a distal portion of the valve delivery device to operably connect the curling alignment tool to the valve delivery device.

[0201] Example 2. A prosthetic valve preparation system according to any example herein, specifically Example 1, wherein the valve delivery device comprises: a steerable guide catheter comprising a handle portion and a guide catheter shaft extending from the handle portion; a balloon catheter extending through the guide catheter; an inflatable balloon mounted to the balloon catheter; a nasal component mounted at the distal end of the valve delivery device to facilitate advancement of the valve delivery device through the patient's vascular system to the target implantation site; and a stylet configured to be removably connected to the distal end of the nasal component; and wherein the valve delivery device is configured so that the implantable prosthetic valve is directly mounted to the inflatable balloon before the valve delivery device is introduced into the patient's vascular system.

[0202] Example 3. A prosthetic valve preparation system according to any example herein, specifically Example 2, wherein the nasal component includes a nasal component lumen, and wherein the stylet includes a stylet shaft, the stylet shaft being configured to be received within the nasal component lumen to selectively connect the stylet to the nasal component.

[0203] Example 4. According to any example herein, in particular, a prosthetic valve preparation system as described in any one of Examples 2 to 3, further comprising a balloon cover assembly, the balloon cover assembly being configured to be operably connected to the inflatable balloon, the balloon cover assembly comprising: a pair of balloon cover flap portions, the pair of balloon cover flap portions being configured to be mounted to opposite sides of the inflatable balloon when the balloon cover assembly is operably connected to the inflatable balloon; and a balloon cover sleeve, the balloon cover sleeve being configured to be The balloon cover assembly, when operably connected to the inflatable balloon, surrounds the pair of balloon cover flap portions to retain the balloon cover flap portions relative to the inflatable balloon; wherein, when the balloon cover assembly is operably connected to the inflatable balloon, the balloon cover sleeve limits the removal of the balloon cover flap portions from the inflatable balloon, and wherein the balloon cover sleeve is configured to axially slide away from the pair of balloon cover flap portions to allow the pair of balloon cover flap portions to be removed from the inflatable balloon.

[0204] Example 5. A prosthetic valve preparation system according to any example herein, specifically Example 4, wherein the balloon cover assembly is configured to engage the curling alignment tool so that when the balloon cover assembly is operably connected to the inflatable balloon, wherein the curling alignment tool is operably connected to the distal portion of the valve delivery device, the balloon cover assembly restricts removal of the curling alignment tool from the distal portion of the valve delivery device.

[0205] Example 6. A prosthetic valve preparation system according to any example described herein, particularly any one of Examples 4 to 5, wherein each balloon cover flap portion includes a proximal balloon engagement surface, wherein the proximal balloon engagement surface is configured to engage the inflatable balloon when the balloon cover assembly is operably connected to the inflatable balloon.

[0206] Example 7. A prosthetic valve preparation system according to any example herein, particularly any one of Examples 4 to 6, wherein the proximal balloon engagement surface is configured to engage the inflatable balloon to mechanically shape at least a portion of the inflatable balloon.

[0207] Example 8. A prosthetic valve preparation system according to any example herein, specifically any one of Examples 1 to 7, wherein the crimper assembly further comprises: a base; a shell, the shell being fixedly mounted to the base and defining a central axis of the crimper assembly; and a plurality of circumferentially arranged nested jaws, the plurality of circumferentially arranged nested jaws supported within the shell, wherein the jaws are capable of moving radially toward and away from the central axis within the shell, and wherein the plurality of jaws collectively define a crimper orifice, the diameter of the crimper orifice varying as the jaws move toward and away from the central axis; wherein the actuator handle is capable of moving relative to the shell to move the jaws toward and away from the central axis, and wherein the second crimp stop is fixedly connected relative to the shell during use of the crimper assembly.

[0208] Example 9. A prosthetic valve preparation system according to any example herein, particularly Example 8, wherein the crimper orifice extends along a crimper orifice length that is equal to or greater than a valve length of the implantable prosthetic valve as measured in a direction parallel to a central axis of the crimper assembly.

[0209] Example 10. A prosthetic valve preparation system according to any example described herein, particularly any one of Examples 1 to 9, wherein the first curl stop includes a receptacle channel that accommodates the slender portion of the second curl stop when the first curl stop is mechanically connected to the second curl stop.

[0210] Example 11. A prosthetic valve preparation system according to any example herein, specifically any one of Examples 1 to 10, wherein the first curl stop includes a gripping feature configured to facilitate removal of the first curl stop from the second curl stop; and wherein the gripping feature includes one or more of a tab, a lever, a protrusion, and a recess.

[0211] Example 12. A prosthetic valve preparation system according to any example herein, specifically any one of Examples 1 to 11, wherein the curling alignment tool comprises: a catheter receptacle configured to accommodate a distal portion of the valve delivery device to position the curling alignment tool in an alignment configuration relative to the valve delivery device; a curling alignment tool distal end configured to engage the distal portion of the valve delivery device to maintain the curling alignment tool in the alignment configuration; and a valve stopper positioned in a proximal region of the curling alignment tool and configured to engage a distal frame end of the annular frame of the implantable prosthetic valve; and wherein the curling alignment tool is configured so that when the curling alignment tool is in the alignment configuration in which the distal end of the curling alignment tool engages the distal portion of the valve delivery device, the implantable prosthetic valve is positioned so that the distal frame end engages the valve stopper to operate to position the implantable prosthetic valve at the target curling position.

[0212] Example 13. A prosthetic valve preparation system according to any example herein, particularly Example 12, wherein the valve delivery device comprises a nasal component and a stylet, the stylet being configured to be removably connected to a distal end of the nasal component, and wherein the curling alignment tool is configured such that when the curling alignment tool is in the alignment configuration, the stylet engages the distal end of the curling alignment tool.

[0213] Example 14. A prosthetic valve preparation system according to any example herein, specifically Example 13, wherein the nasal component includes a nasal component lumen, wherein the stylet includes a stylet shaft, the stylet shaft being configured to be received within the nasal component lumen to selectively connect the stylet to the nasal component, wherein the valve delivery device includes a manipulable guide catheter and a balloon catheter extending through the guide catheter, and wherein the stylet shaft is configured to extend within the nasal component lumen and engage the distal end of the balloon catheter, such that when the curling alignment tool is in the alignment configuration in which the distal end of the curling alignment tool engages the distal portion of the valve delivery device, the axial position of the valve stop coincides with at least a portion of the target curling position.

[0214] Example 15. A curling alignment tool comprising: a catheter receptacle configured to accommodate a distal portion of a valve delivery device to position the curling alignment tool in an alignment configuration relative to the valve delivery device; a curling alignment tool distal end configured to engage the distal portion of the valve delivery device to maintain the curling alignment tool in the alignment configuration; and a valve stopper positioned in a proximal region of the curling alignment tool and configured to engage a distal frame end of an annular frame of an implantable prosthetic valve; and wherein the curling alignment tool is configured so that when the curling alignment tool is in the alignment configuration in which the distal end of the curling alignment tool engages the distal portion of the valve delivery device, the implantable prosthetic valve is positioned so that the distal frame end engages the valve stopper to operate to position the implantable prosthetic valve at a target curling position.

[0215] Example 16. A curling alignment tool according to any example herein, particularly Example 15, wherein the curling alignment tool is configured to slide longitudinally onto the distal portion of the valve delivery device to operably connect the curling alignment tool to the valve delivery device.

[0216] Example 17. According to any example herein, specifically any one of Examples 15 to 16, the curling alignment tool is configured such that when the curling alignment tool is in the alignment configuration, the curling alignment tool is at least partially restricted from being removed from the valve delivery device.

[0217] Example 18. According to any example herein, specifically any one of Examples 15 to 17, the curling alignment tool further comprises a distal alignment indicator, wherein the distal alignment indicator is configured to provide a visual indication that the curling alignment tool is in the alignment configuration relative to the valve delivery device, wherein the distal alignment indicator comprises a window that allows visual inspection of the valve delivery device through the curling alignment tool, and wherein the curling alignment tool is configured such that when the curling alignment tool is in the alignment configuration relative to the valve delivery device, components of the valve delivery device are axially aligned with one or both of the distal edge of the window and the proximal edge of the window.

[0218] Example 19. A method for mounting an implantable prosthetic valve to a valve delivery device, the method comprising: inserting a balloon catheter of the valve delivery device into a central passage of a frame of the implantable prosthetic valve; partially curling the annular frame of the implantable prosthetic valve with a curler assembly; and completely curling the annular frame of the implantable prosthetic valve.

[0219] Example 20. The method described in any example herein, particularly Example 19, further comprising, after partially curling the annular frame of the implantable prosthetic valve and before completely curling the annular frame of the implantable prosthetic valve: operably connecting a curling alignment tool to a distal portion of the valve delivery device to position the curling alignment tool in an alignment configuration relative to the valve delivery device; and positioning the implantable prosthetic valve to engage the curling alignment tool.

[0220] Example 21. A method according to any example herein, specifically Example 20, wherein the valve delivery device includes a nasal component and a stylet, the nasal component being mounted at a distal end of the valve delivery device, the stylet being configured to be removably connected to the distal end of the nasal component, wherein the curling alignment tool includes a window that allows visual inspection of the valve delivery device through the curling alignment tool, and wherein the method further includes visually verifying that the stylet is axially aligned with one of the distal edge of the window or the proximal edge of the window.

[0221] Example 22. A method according to any example herein, specifically any one of Examples 20 to 21, wherein the valve delivery device includes a nasal component and a stylet, the nasal component being mounted at a distal end of the valve delivery device, the stylet being configured to be removably connected to the distal end of the nasal component, wherein the curling alignment tool includes a curling alignment tool distal end, the curling alignment tool distal end including a distal orifice, wherein operably connecting the curling alignment tool to the distal portion of the valve delivery device includes engaging the stylet with the curling alignment tool distal end, and wherein engaging the stylet includes inserting the stylet at least partially through the distal orifice.

[0222] Example 23. A method according to any example described herein, specifically any one of Examples 20 to 22, wherein positioning the implantable prosthetic valve to engage the curling alignment tool includes axially translating the implantable prosthetic valve relative to the valve delivery device so that the distal frame end of the annular frame engages the valve stop of the curling alignment tool.

[0223] Example 24. A method according to any example herein, specifically any one of Examples 19 to 23, wherein the crimper assembly includes: an actuator handle, which is configured to be manually actuated to curl the implantable prosthetic valve around the valve delivery device; a second curling stop, which limits the entire range of motion of the actuator handle; and a first curling stop, which limits a portion of the range of motion of the actuator handle and is configured to be selectively and operably connected to the second curling stop; wherein partially curling the annular frame includes actuating the actuator handle to engage the first curling stop with the first curling stop operably connected to the second curling stop, wherein fully curling the annular frame includes actuating the actuator handle to engage the second curling stop, and wherein the method further includes removing the first curling stop from the second curling stop after partially curling the annular frame and before fully curling the annular frame.

[0224] Example 25. A crimper assembly comprising: an actuator handle configured to be manually actuated to curl an implantable prosthetic valve around a valve delivery device, a second crimping stop that limits the entire range of motion of the actuator handle, and a first crimping stop that limits a portion of the range of motion of the actuator handle and is configured to be selectively and operably connected to the second crimping stop.

[0225] Example 26. According to any example herein, in particular the curler assembly described in Example 25, further comprising: a base; a shell, which is fixedly mounted to the base and defines a central axis of the curler assembly; and a plurality of circumferentially arranged nested jaws, which are supported within the shell, wherein the jaws are capable of moving radially toward and away from the central axis within the shell, and wherein the plurality of jaws collectively define a curler orifice, the diameter of which changes as the jaws move toward and away from the central axis.

[0226] Example 27. The crimper assembly of any example herein, particularly example 26, wherein the actuator handle is movable relative to the housing to move the jaws toward and away from the central axis.

[0227] Example 28. The crimper assembly according to any example herein, particularly any one of examples 25 to 27, wherein the second crimp stop is fixedly coupled relative to the housing during use of the crimper assembly.

[0228] Example 29. A curler assembly according to any example herein, specifically any one of Examples 25 to 28, wherein, when the first curling stop is operably connected to the second curling stop, the actuator handle is actuated to engage the first curling stop operation to allow the curler orifice to reach a first stop diameter, and wherein, when the first curling stop is removed from the second curling stop, the actuator handle is actuated to engage the second curling stop operation to allow the curler orifice to reach a second stop diameter that is smaller than the first stop diameter.

[0229] Example 30. A crimper assembly according to any example herein, specifically any one of Examples 25 to 29, wherein the crimper orifice extends along a crimper orifice length, as measured along a direction parallel to a central axis of the crimper assembly, the crimper orifice length being equal to or greater than a valve length of the implantable prosthetic valve.

[0230] Example 31. A curler assembly according to any example herein, specifically any one of Examples 25 to 30, wherein the first curling stop includes a first curling stop body, the first curling stop body defining a first curling stop end and terminating at the first curling stop end, and wherein the curler assembly is configured such that the actuator handle engages the first curling stop end during use of the curler assembly and when the first curling stop is operably connected to the second curling stop.

[0231] Example 32. A curler assembly according to any example herein, specifically any one of Examples 25 to 31, wherein the second curling stop includes a second curling stop body, the second curling stop body defines a second curling stop end and terminates at the second curling stop end, and wherein the curler assembly is configured such that the actuator handle engages the second curling stop end during use of the curler assembly and when the first curling stop is removed from the second curling stop.

[0232] Example 33. A curler assembly according to any example herein, specifically any one of Examples 25 to 32, wherein the first curling stop includes a second curling stop receptacle, the second curling stop receptacle being configured to accommodate a portion of the second curling stop, optionally a second curling stop end of the second curling stop body of the second curling stop, when the first curling stop is operably connected to the second curling stop.

[0233] Example 34. A crimper assembly according to any example herein, particularly Example 33, wherein the second crimp stop receptacle includes a receptacle channel that receives the elongated portion of the second crimp stop when the first crimp stop is operably connected to the second crimp stop.

[0234] Example 35. The crimper assembly according to any example herein, particularly any one of Examples 25 to 34, wherein the first crimp stop includes a gripping feature configured to facilitate removal of the first crimp stop from the second crimp stop.

[0235] Example 36. The crimper assembly of any example herein, particularly Example 35, wherein the gripping feature is configured to be gripped by a user to enable the user to apply a torque on the first curling stop to remove the first curling stop from the second curling stop.

[0236] Example 37. The crimper assembly according to any example herein, particularly any one of Examples 35 to 36, wherein the gripping feature is configured to be gripped by a user to enable the user to pull the first curl stop away from the second curl stop.

[0237] Example 38. A crimper assembly according to any example herein, particularly any one of examples 35 to 37, wherein the gripping feature comprises one or more of a tab, a lever, a protrusion, and a recess.

[0238] Example 39. A curler assembly according to any example herein, particularly any one of Examples 25 to 38, wherein during use of the curler assembly, the second curling stop is connected to one or both of the base and the housing at a curling stop attachment location.

[0239] Example 40. The crimper assembly of any example herein, particularly Example 39, wherein the second crimp stop is not configured to be removed from the crimp stop attachment location without damaging the crimper assembly.

[0240] Example 41. The crimper assembly of any example herein, particularly Example 39, wherein the second crimp stop is configured to be selectively and repeatedly coupled to and removed from the crimp stop attachment location without damaging the crimper assembly.

[0241] Example 42. A curler assembly according to any example herein, specifically any one of Examples 39 to 41, further comprising: a base; a shell fixedly mounted to the base and defining a central axis of the curler assembly; and a plurality of circumferentially arranged nested jaws supported within the shell, wherein the jaws are capable of radially moving toward and away from the central axis within the shell, and wherein the plurality of jaws collectively define a curler orifice, the diameter of the curler orifice changing as the jaws move toward and away from the central axis; wherein one or both of the base and the shell include a curling stop receptacle, the curling stop receptacle defining an attachment position of the curling stop.

[0242] Example 43. According to any example herein, specifically the crimper assembly described in Example 42, wherein the second crimp stop is configured to be operably connected to the crimp stop container by one or more of a friction fit connection, a snap fit connection, a latch connection, and a key connection.

[0243] Example 44. A valve delivery device comprising: a steerable guide catheter comprising a handle portion and a guide catheter shaft extending from the handle portion; a balloon catheter extending through the guide catheter; an inflatable balloon mounted to the balloon catheter; a nasal component mounted at a distal end of the valve delivery device to facilitate advancement of the valve delivery device through a patient's vascular system to a target implantation site; and a stylet configured to be removably connected to the distal end of the nasal component; wherein the valve delivery device is configured such that an implantable prosthetic valve is directly mounted to the inflatable balloon before the valve delivery device is introduced into the patient's vascular system.

[0244] Example 45. According to any example herein, in particular the valve delivery device described in Example 44, the balloon catheter includes a proximal portion adjacent to the handle portion, a distal portion opposite the proximal portion, and a balloon catheter shaft extending from the proximal portion and extending through the handle portion and the guide catheter shaft.

[0245] Example 46. The valve delivery device of any example herein, particularly Example 45, wherein the inflatable balloon is mounted to the distal portion.

[0246] Example 47. A valve delivery device according to any example herein, particularly any one of Examples 44 to 46, wherein the guide catheter and the balloon catheter are configured to slide longitudinally relative to each other to facilitate delivery and positioning of the implantable prosthetic valve at the target implantation site.

[0247] Example 48. According to any example herein, specifically any one of Examples 44 to 47, the valve delivery device, wherein the balloon catheter shaft is an outer balloon catheter shaft; and wherein the balloon catheter further comprises an inner balloon catheter shaft, which extends from the proximal portion and coaxially passes through the outer balloon catheter shaft and the inflatable balloon.

[0248] Example 49. A valve delivery device according to any example herein, in particular Example 48, wherein the balloon catheter comprises a fluid passage, the fluid passage being fluidly connected to an annular space defined between the inner balloon catheter shaft and the outer balloon catheter shaft, and being fluidly connectable to a fluid source for inflating the inflatable balloon.

[0249] Example 50. A valve delivery device according to any example herein, particularly any one of Examples 44 to 49, wherein the nasal component is configured to move independently of one or both of the guide catheter and the balloon catheter.

[0250] Example 51. A valve delivery device according to any example herein, specifically any one of Examples 44 to 50, wherein the nasal component includes a nasal component lumen, and wherein the stylet includes a stylet shaft configured to be received within the nasal component lumen to selectively connect the stylet to the nasal component.

[0251] Example 52. According to any example herein, specifically the valve delivery device described in Example 51, wherein the guide needle shaft is configured to extend within the nasal component lumen and engage the distal end of the balloon catheter, so that when the curling alignment tool is in an alignment configuration in which the distal end of the curling alignment tool engages the distal portion of the valve delivery device, the axial position of the valve stop of the curling alignment tool coincides with at least a portion of the target curling position of the implantable prosthetic valve.

[0252] EXAMPLES According to any example herein, particularly any one of Examples 44 to 52, the valve delivery device wherein the stylet is more rigid than the nasal component.

[0253] Example 54. A valve delivery device according to any example herein, specifically any one of Examples 44 to 53, wherein the implantable prosthetic valve comprises an annular frame defining a central passage of the frame and a valve assembly positioned within the central passage of the frame, and wherein the annular frame is radially expandable and contractible to transition the implantable prosthetic valve between a delivery configuration and an operating configuration, wherein the delivery configuration is sized for delivery through the patient's vascular system and wherein the operating configuration is sized to be operably mounted at the target implantation site.

[0254] Example 55. The valve delivery device of any example herein, particularly Example 54, wherein the implantable prosthetic valve is restricted from translating relative to the inflatable balloon when the implantable prosthetic valve is mounted to the inflatable balloon in the delivery configuration.

[0255] Example 56. A valve delivery device according to any example herein, particularly any one of Examples 54 to 55, wherein the valve delivery device is configured to operate the inflatable balloon by inflating the implantable prosthetic valve mounted to the inflatable balloon to transition the implantable prosthetic valve from the delivery configuration to the operating configuration.

[0256] Example 57. A valve delivery device according to any example described herein, specifically any one of Examples 54 to 56, wherein the annular frame further expands and contracts radially to transition the implantable prosthetic valve to an intermediate configuration defined between the delivery configuration and the operating configuration, and wherein, when the implantable prosthetic valve is mounted to the inflatable balloon in the intermediate configuration, the implantable prosthetic valve engages the inflatable balloon such that the implantable prosthetic valve is at least partially fixed in an appropriate position relative to the inflatable balloon unless the implantable prosthetic valve is intentionally repositioned by a user.

[0257] Example 58. A combination of a valve delivery device according to any example herein, particularly any one of Examples 44 to 57, and the implantable prosthetic valve.

[0258] Example 59. A curling alignment tool configured to facilitate curling of an implantable prosthetic valve relative to an inflatable balloon of a valve delivery device, wherein the curling alignment tool is configured to engage the implantable prosthetic valve to position the implantable prosthetic valve at a target curling position relative to the valve delivery device.

[0259] Example 60. According to any example herein, specifically the curling alignment tool described in Example 59, wherein the curling alignment tool includes: a catheter receptacle, the catheter receptacle being configured to accommodate the distal portion of the valve delivery device to position the curling alignment tool in an alignment configuration relative to the valve delivery device; a curling alignment tool distal end, the curling alignment tool distal end being configured to engage the distal portion of the valve delivery device to maintain the curling alignment tool in the alignment configuration; and a valve stopper, the valve stopper being positioned in the proximal region of the curling alignment tool and being configured to engage the distal frame end of the annular frame of the implantable prosthetic valve; and wherein the curling alignment tool is configured so that when the curling alignment tool is in the alignment configuration in which the distal end of the curling alignment tool engages the distal portion of the valve delivery device, the implantable prosthetic valve is positioned so that the distal frame end engages the valve stopper to operate to position the implantable prosthetic valve at the target curling position.

[0260] Example 61. A curling alignment tool according to any example herein, particularly Example 60, wherein the curling alignment tool is configured to slide longitudinally onto the distal portion of the valve delivery device to operably connect the curling alignment tool to the valve delivery device.

[0261] Example 62. According to any example herein, specifically the curling alignment tool described in any of Examples 59 to 61, wherein the curling alignment tool is configured to at least partially restrict removal of the curling alignment tool from the valve delivery device when the curling alignment tool is in an aligned configuration relative to the valve delivery device.

[0262] Example 63. According to any example herein, specifically any one of Examples 59 to 62, the curling alignment tool is configured to engage the distal portion of the valve delivery device with one or more of a friction fit, a mechanical fit, a latch fit, and a snap fit fit.

[0263] Example 64. A curling alignment tool according to any example herein, specifically any one of Examples 59 to 63, wherein the curling alignment tool includes a valve stop positioned in a proximal region of the curling alignment tool and configured to engage a distal frame end of an annular frame of the implantable prosthetic valve, and wherein the curling alignment tool terminates at a proximal end of the curling alignment tool that defines the valve stop.

[0264] Example 65. A curling alignment tool according to any example herein, specifically any one of Examples 59 to 63, wherein the curling alignment tool includes a valve stopper positioned in a proximal region of the curling alignment tool and configured to engage a distal frame end of an annular frame of the implantable prosthetic valve, and wherein the curling alignment tool includes a stepped inner surface that defines the valve stopper.

[0265] Example 66. A curling alignment tool according to any example herein, in particular Example 65, wherein the curling alignment tool is configured such that when the distal frame end engages the valve stop, the implantable prosthetic valve is partially contained within the curling alignment tool.

[0266] Example 67. A curling alignment tool according to any example herein, specifically any one of Examples 59 to 66, wherein the valve delivery device includes a nasal component and a stylet configured to be removably connected to the distal end of the nasal component, and wherein the curling alignment tool is configured such that when the curling alignment tool is in an alignment configuration relative to the valve delivery device, the stylet engages the distal end of the curling alignment tool.

[0267] Example 68. A curling alignment tool according to any example herein, specifically Example 67, wherein the curling alignment tool is configured such that when the curling alignment tool is in an aligned configuration relative to the valve delivery device, the inner diameter of the curling alignment tool cooperates with the outer diameter of the guide needle.

[0268] Example 69. A curling alignment tool according to any example herein, specifically any one of Examples 59 to 68, wherein the distal end of the curling alignment tool includes a distal orifice, and when the curling alignment tool is in an aligned configuration relative to the valve delivery device, the distal orifice accommodates the distal portion of the valve delivery device.

[0269] Example 70. According to any example herein, specifically the curling alignment tool of Example 69, wherein the valve delivery device includes a nasal component and a stylet, the stylet being configured to be removably connected to the distal end of the nasal component, and wherein the curling alignment tool is configured such that when the curling alignment tool is in the alignment configuration, the stylet extends at least partially through the distal orifice.

[0270] Example 71. According to any example herein, specifically any one of Examples 59 to 70, the curling alignment tool further comprises a distal alignment indicator configured to provide a visual indication that the curling alignment tool is in an aligned configuration relative to the valve delivery device.

[0271] Example 72. The crimp alignment tool of any example herein, particularly Example 71, wherein the distal alignment indicator comprises a window that allows visual inspection of the valve delivery device through the crimp alignment tool.

[0272] Example 73. According to any example herein, specifically the curling alignment tool described in Example 72, wherein the curling alignment tool is configured such that when the curling alignment tool is in the alignment configuration relative to the valve delivery device, components of the valve delivery device are axially aligned with one or both of the distal edge of the window and the proximal edge of the window.

[0273] Example 74. According to any example herein, specifically any one of Examples 71 to 73, the distal alignment indicator includes one or more visual markers such that when the curling alignment tool is in the alignment configuration relative to the valve delivery device, components of the valve delivery device are axially aligned with the visual markers.

[0274] Example 75. According to any example herein, in particular the curl alignment tool of Example 74, wherein the visual identification comprises one or more of a mark, a color mark, a printed mark, an embossed mark, a debossed mark, a line, and a symbol.

[0275] Example 76. A balloon cover assembly comprising: a pair of balloon cover flap portions, the pair of balloon cover flap portions being configured to be mounted to opposite sides of an inflatable balloon when the balloon cover assembly is operably connected to the inflatable balloon; and a balloon cover sleeve, the balloon cover sleeve being configured to surround the pair of balloon cover flap portions to hold the balloon cover flap portions relative to the inflatable balloon when the balloon cover assembly is operably connected to the inflatable balloon; wherein, when the balloon cover assembly is operably connected to the inflatable balloon, the balloon cover sleeve restricts the balloon cover flap portions from being removed from the inflatable balloon, and wherein the balloon cover sleeve is configured to slide axially away from the pair of balloon cover flap portions to allow the pair of balloon cover flap portions to be removed from the inflatable balloon.

[0276] Example 77. A balloon cover assembly according to any example herein, in particular Example 76, wherein each balloon cover flap portion includes a proximal balloon engagement surface, wherein the proximal balloon engagement surface is configured to engage the inflatable balloon when the balloon cover assembly is operably connected to the inflatable balloon.

[0277] Example 78. The balloon cover assembly of any example herein, particularly Example 77, wherein the proximal balloon engagement surface is configured to mechanically shape at least a portion of the inflatable balloon.

[0278] Example 79. A balloon cover assembly according to any example herein, specifically any one of Examples 77 to 78, wherein the proximal balloon engagement surface is configured to engage the inflatable balloon when the balloon cover assembly is operably connected to the inflatable balloon to limit axial translation of the balloon cover flap portion relative to the inflatable balloon.

[0279] Example 80. A balloon cover assembly according to any example herein, specifically any one of Examples 77 to 79, wherein the proximal balloon engagement surface includes one or more locking ribs that extend radially toward the inflatable balloon when the balloon cover assembly is operably connected to the inflatable balloon.

[0280] Example 81. A balloon cover assembly according to any example herein, specifically Example 80, wherein the locking ribs of each proximal balloon mating surface of the pair of balloon cover flap portions are staggered relative to each other so that when the balloon cover assembly is operably connected to the inflatable balloon, the locking ribs of the proximal balloon mating surface of each balloon cover flap portion in the pair of balloon cover flap portions are staggered with each other.

[0281] Example 82. A balloon cover assembly according to any example herein, specifically any one of Examples 77 to 81, wherein the corresponding proximal balloon engagement surfaces of each of the pair of balloon cover flap portions are configured to engage with each other to mechanically hold the balloon cover flap portions against each other when the balloon cover assembly is operably connected to the inflatable balloon.

[0282] Example 83. The balloon cover assembly of any example herein, particularly any one of Examples 76 to 80, wherein the pair of balloon cover flap portions are configured to engage with each other when the balloon cover assembly is operably connected to the inflatable balloon.

[0283] Example 84. The balloon cover assembly of any example herein, particularly any one of Examples 76 to 83, wherein the pair of balloon cover flap portions are configured to abut each other when the balloon cover assembly is operably connected to the inflatable balloon.

[0284] Example 85. The balloon cover assembly of any example herein, particularly any one of Examples 76 to 84, wherein the pair of balloon cover flap portions are configured to mate with each other when the balloon cover assembly is operably coupled to the inflatable balloon.

[0285] Example 86. A balloon cover assembly according to any example herein, specifically any one of Examples 76 to 85, wherein the balloon cover assembly is configured to engage a curling alignment tool, which is configured to accommodate a distal portion of a valve delivery device, such that when the balloon cover assembly is operably connected to the inflatable balloon, wherein the curling alignment tool is operably connected to the distal portion of the valve delivery device, the balloon cover assembly restricts removal of the curling alignment tool from the distal portion of the valve delivery device.

[0286] Example 87. A balloon cover assembly according to any example herein, in particular Example 86, wherein the curling alignment tool includes a flap engagement feature, and wherein each balloon cover flap portion includes a curling alignment tool engagement feature, and when the balloon cover assembly is operably engaged with the curling alignment tool, the curling alignment tool engagement feature engages the flap engagement feature.

[0287] Example 88. According to any example herein, in particular the balloon cover assembly of Example 87, wherein the flap engagement feature includes an annular groove; and wherein each curling alignment tool engagement feature includes an engagement tooth, the engagement tooth being configured to be received within a portion of the annular groove when the balloon cover assembly is operably engaged with the curling alignment tool to limit axial translation of the curling alignment tool relative to the balloon cover assembly.

[0288] Example 89. A method for mounting an implantable prosthetic valve to a valve delivery device, the method comprising: inserting a balloon catheter of the valve delivery device into a central passage of a frame of the implantable prosthetic valve; partially curling the annular frame of the implantable prosthetic valve with a curler assembly; operably connecting a curling alignment tool to a distal portion of the valve delivery device to position the curling alignment tool in an alignment configuration relative to the valve delivery device; positioning the implantable prosthetic valve to engage the curling alignment tool; and completely curling the annular frame of the implantable prosthetic valve; and wherein one or more of the following are true: the curler assembly is a curler assembly according to any example herein, specifically any one of Examples 25 to 43; the valve delivery device is a valve delivery device according to any example herein, specifically any one of Examples 43 to 57; and the curling alignment tool is a curling alignment tool according to any example herein, specifically any one of Examples 58 to 74.

[0289] Example 90. The method of any example herein, specifically Example 89, wherein partially curling the annular frame of the implantable prosthetic valve includes radially compressing the implantable prosthetic valve so that the annular frame reaches a diameter at least substantially equal to a first stop diameter, and wherein fully curling the annular frame of the implantable prosthetic valve includes radially compressing the implantable prosthetic valve so that the annular frame reaches a diameter at least substantially equal to a second stop diameter that is smaller than the first stop diameter.

[0290] Example 91. A method according to any example herein, particularly Example 90, wherein partially curling the annular frame includes transitioning the implantable prosthetic valve to an intermediate configuration in which the implantable prosthetic valve engages the inflatable balloon of the valve delivery device so that the implantable prosthetic valve is at least partially fixed in an appropriate position relative to the inflatable balloon unless the implantable prosthetic valve is intentionally repositioned by a user, and wherein positioning the implantable prosthetic valve to engage the curling alignment tool is performed with the implantable prosthetic valve in the intermediate configuration.

[0291] Example 92. A method according to any example herein, specifically any one of Examples 89 to 91, wherein the valve delivery device further includes: a balloon cover assembly, which is operably connected to the inflatable balloon of the valve delivery device, the balloon cover assembly including: a pair of balloon cover flap parts, the pair of balloon cover flap parts are mounted to opposite sides of the inflatable balloon; and a balloon cover sleeve, the balloon cover sleeve surrounds the pair of balloon cover flap parts to hold the balloon cover flap parts relative to the inflatable balloon; and wherein the method further includes removing the balloon cover assembly from the inflatable balloon before inserting the balloon catheter into the central passage of the frame.

[0292] Example 93. A method according to any example herein, specifically Example 92, wherein removing the balloon cover assembly from the inflatable balloon includes: removing the balloon cover sleeve from the pair of balloon cover flap portions; and after removing the balloon cover sleeve, removing the pair of balloon cover flap portions from the inflatable balloon.

[0293] Example 94. A method according to any example herein, specifically any one of Examples 89 to 93, wherein operably connecting the curling alignment tool to the distal portion of the valve delivery device includes engaging the distal portion of the valve delivery device with the curling alignment tool to position the curling alignment tool in the alignment configuration.

[0294] Example 95. A method according to any example herein, particularly any one of Examples 89 to 94, wherein operably connecting the curling alignment tool to the distal portion of the valve delivery device includes axially advancing the curling alignment tool toward the inflatable balloon until further axial advancement of the curling alignment tool is limited.

[0295] Example 96. A method according to any example herein, particularly any one of Examples 89 to 95, wherein operably connecting the curling alignment tool to the distal portion of the valve delivery device includes engaging a guide needle of the valve delivery device with a curling alignment tool distal end of the curling alignment tool.

[0296] Example 97. The method of any example herein, particularly Example 96, wherein the distal end of the curling alignment tool includes a distal orifice; and wherein engaging the stylet includes inserting the stylet at least partially through the distal orifice.

[0297] Example 98. A method according to any example herein, specifically any one of Examples 89 to 97, wherein the curling alignment tool includes a distal alignment indicator, the distal alignment indicator being configured as a visual indication that the curling alignment tool is in the alignment configuration relative to the valve delivery device, and wherein operably connecting the curling alignment tool to the distal portion of the valve delivery device includes visual verification of the axial position of the valve delivery device relative to the distal alignment indicator.

[0298] Example 99. The method of any example herein, particularly Example 98, wherein the distal alignment indicator includes a window that allows visual inspection of the valve delivery device through the curling alignment tool, and wherein the visual verification of the axial position includes verifying that a component of the valve delivery device is axially aligned with one or both of a distal edge of the window and a proximal edge of the window.

[0299] Example 100. The method of any example herein, particularly Example 99, wherein the component of the valve delivery device is a proximal edge of a stylet of the valve delivery device.

[0300] Example 101. A method according to any example herein, particularly any one of Examples 98 to 100, wherein the distal alignment indicator comprises one or more visual markers, and wherein verifying the axial position comprises verifying that a component of the valve delivery device is axially aligned with the visual marker.

[0301] Example 102. According to any example herein, specifically the method described in any of Examples 89 to 101, further comprising operably connecting the first curling stop of the curler assembly to the second curling stop of the curler assembly before partially curling the annular frame of the implantable prosthetic valve.

[0302] Example 103. A method according to any example herein, specifically Example 102, wherein the first curling stop includes a second curling stop container, the second curling stop container is configured to accommodate a portion of the second curling stop, and wherein the first curling stop is operably connected to the second curling stop includes inserting the second curling stop into the second curling stop container.

[0303] Example 104. A method according to any example herein, specifically any one of Examples 89 to 103, wherein partially curling the annular frame of the implantable prosthetic valve includes directly engaging the implantable prosthetic valve with jaws of the crimper assembly.

[0304] Example 105. A method according to any example herein, specifically any one of Examples 89 to 104, wherein partially curling the annular frame of the implantable prosthetic valve includes: positioning the implantable prosthetic valve within a crimper orifice of the crimper assembly with a second crimping stop of the crimper assembly fixedly connected relative to a housing of the crimper assembly and with a first crimping stop of the crimper assembly operably connected to the second crimping stop; and actuating an actuator handle of the crimper assembly to engage the first crimping stop.

[0305] Example 106. The method of any example herein, particularly Example 105, wherein positioning the implantable prosthetic valve within the crimper orifice includes positioning such that the entire valve length of the implantable prosthetic valve is contained within the crimper orifice length of the crimper orifice.

[0306] Example 107. A method according to any example described herein, specifically any one of Examples 89 to 106, wherein positioning the implantable prosthetic valve relative to the curling alignment tool includes axially translating the implantable prosthetic valve relative to the valve delivery device so that the distal frame end of the annular frame engages the valve stop of the curling alignment tool.

[0307] Example 108. A method according to any example herein, specifically any one of Examples 89 to 107, further comprising removing the first curling stop of the curler assembly from the second curling stop of the curler assembly before completely curling the annular frame of the implantable prosthetic valve.

[0308] Example 109. A method according to any example herein, specifically Example 108, wherein the first curling stop includes a gripping feature configured to facilitate removal of the first curling stop from the second curling stop, and wherein removing the first curling stop from the second curling stop includes gripping the gripping feature until one or both of the following occur: pivoting the first curling stop relative to the second curling stop; and pulling the first curling stop away from the second curling stop.

[0309] Example 110. A method according to any example herein, specifically any one of Examples 89 to 109, wherein fully crimping the annular frame of the implantable prosthetic valve includes directly engaging the implantable prosthetic valve with jaws of the crimper assembly.

[0310] Example 111. A method according to any example herein, specifically any one of Examples 89 to 110, wherein fully curling the annular frame of the implantable prosthetic valve includes: positioning the implantable prosthetic valve within the crimper orifice of the crimper assembly with a second crimping stop of the crimper assembly fixedly connected relative to a housing of the crimper assembly and with a first crimping stop of the crimper assembly removed from the second crimping stop; and actuating an actuator handle of the crimper assembly to engage the second crimping stop.

[0311] Example 112. A method according to any example herein, particularly Example 111, wherein positioning the implantable prosthetic valve within the crimper orifice includes positioning such that the entire valve length of the implantable prosthetic valve is contained within the crimper orifice length of the crimper orifice.

[0312] Example 113. A method according to any example herein, specifically any one of Examples 111 to 112, further comprising, after actuating the actuator handle to engage the second curl stop: actuating the actuator handle to release the plurality of jaws of the curler assembly from the implantable prosthetic valve; and repeating the actuating of the actuator handle to engage the second curl stop and the actuating of the actuator handle to release the jaws from the implantable prosthetic valve.

[0313] Example 114. The method of any example herein, particularly Example 113, wherein the repeating includes repeating such that the actuating the actuator handle to engage the second curl stop is performed one or more of at least two times, at least three times, at least four times, and at most five times.

[0314] Example 115. According to any example herein, particularly any one of Examples 89 to 114, the method further comprising removing the crimping alignment tool from the valve delivery device after the annular frame is fully crimped.

[0315] Example 116. A method according to any example herein, particularly any one of Examples 89 to 115, further comprising removing the stylet of the valve delivery device from the nasal portion of the valve delivery device after removing the curling alignment tool from the valve delivery device.

[0316] Example 117. The prosthetic valve preparation assembly according to any example herein, particularly any one of Examples 1 to 14, wherein one or more components of the valve preparation assembly are sterilized.

[0317] Example 118. A method comprising sterilizing one or more components of a valve preparation assembly according to any example herein, particularly any one of Examples 1-14.

[0318] Example 119. The crimp alignment tool according to any example herein, particularly any one of Examples 15 to 18, wherein the crimp alignment tool is sterilized.

[0319] Example 120. A method comprising sterilizing a crimp alignment tool according to any example herein, particularly any one of Examples 15 to 18.

[0320] Example 121. The crimper assembly according to any example herein, particularly any one of Examples 25 to 43, wherein one or more components of the crimper assembly are sterilized.

[0321] Example 122. A method comprising sterilizing one or more components of a crimper assembly according to any example herein, particularly any one of Examples 25-43.

[0322] Example 123. A valve delivery device according to any example herein, particularly any one of Examples 44 to 58, wherein one or more components of the valve delivery device are sterilized.

[0323] Example 124. A method comprising sterilizing one or more components of a valve delivery device according to any example herein, particularly any one of Examples 44-58.

[0324] Example 125. The curl alignment tool according to any example herein, particularly any one of Examples 59 to 75, wherein the curl alignment tool is sterilized.

[0325] Example 126. A method comprising sterilizing a crimp alignment tool according to any example herein, particularly any one of Examples 59 to 75.

[0326] Example 127. The balloon cover assembly of any example herein, particularly any one of Examples 76 to 88, wherein one or more components of the balloon cover assembly are sterilized.

[0327] Example 128. A method comprising sterilizing one or more components of a balloon cover assembly according to any example herein, particularly any one of Examples 76-88.

[0328] Unless otherwise stated, features described herein with respect to any example may be combined with other features described in any one or more of the other examples. For example, any one or more of the features of one prosthetic valve preparation system may be combined with any one or more of the features of another prosthetic valve preparation system. As another example, any one or more of the features of one crimper assembly may be combined with any one or more of the features of another crimper assembly.

[0329] In view of the many possible ways in which the principles of the present disclosure can 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 present disclosure, nor should they be taken as limiting the claims. Instead, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A crimper assembly comprising: an actuator handle configured to be manually actuated to crimp the implantable prosthetic valve around the valve delivery device; a second curl stop that limits the overall range of motion of the actuator handle; as well as A first curl stop defines a portion of the range of motion of the actuator handle and is configured to be selectively and operably coupled to the second curl stop.

2. The crimper assembly of claim 1, further comprising: base; a housing fixedly mounted to the base and defining a crimper assembly central axis; and A plurality of circumferentially arranged nested jaws are supported within the housing, wherein the jaws are capable of radially moving within the housing toward and away from the central axis, and wherein the plurality of jaws collectively define a crimper orifice having a diameter that varies as the jaws move toward and away from the central axis.

3. The crimper assembly of claim 2, wherein the actuator handle is movable relative to the housing to move the jaws toward and away from the central axis.

4. The crimper assembly of any one of claims 1 to 3, wherein the second crimp stop is fixedly coupled relative to the housing during use of the crimper assembly.

5. The crimper assembly according to any one of claims 1 to 4, wherein: When the first crimp stop is operably coupled to the second crimp stop, actuating the actuator handle to engage the first crimp stop to operate the crimper aperture to a first stop diameter, and wherein when the first crimp stop is removed from the second crimp stop, actuating the actuator handle to engage the second crimp stop operates to bring the crimper aperture to a second stop diameter that is smaller than the first stop diameter.

6. The crimper assembly of any one of claims 1 to 5, wherein the crimper orifice extends along a crimper orifice length that is equal to or greater than a valve length of the implantable prosthetic valve as measured along a direction parallel to a central axis of the crimper assembly.

7. A curler assembly according to any one of claims 1 to 6, wherein the first curling stop includes a first curling stop body, the first curling stop body defines a first curling stop end and terminates at the first curling stop end, and wherein the curler assembly is configured so that the actuator handle engages the first curling stop end during use of the curler assembly and when the first curling stop is operably connected to the second curling stop.

8. A curler assembly according to any one of claims 1 to 7, wherein the second curling stop includes a second curling stop body, the second curling stop body defines a second curling stop end and terminates at the second curling stop end, and wherein the curler assembly is configured so that the actuator handle engages the second curling stop end during use of the curler assembly and when the first curling stop is removed from the second curling stop.

9. A curler assembly according to any one of claims 1 to 8, wherein the first curling stop includes a second curling stop receptacle, and the second curling stop receptacle is configured to accommodate a portion of the second curling stop when the first curling stop is operably connected to the second curling stop, optionally a second curling stop end of the second curling stop body of the second curling stop.

10. The crimper assembly of claim 9, wherein the second crimp stop receptacle includes a receptacle channel that receives an elongated portion of the second crimp stop when the first crimp stop is operably coupled to the second crimp stop.

11. The crimper assembly of any one of claims 1 to 10, wherein the first crimp stop includes a gripping feature configured to facilitate removal of the first crimp stop from the second crimp stop.

12. The crimper assembly of claim 11, wherein the gripping feature is configured to be gripped by a user to enable the user to apply a torque on the first curl stop to remove the first curl stop from the second curl stop.

13. The crimper assembly of claim 11, wherein the gripping feature is configured to be gripped by a user to enable the user to pull the first curl stop away from the second curl stop.

14. The crimper assembly of claim 11, wherein the gripping feature comprises one or more of a tab, a lever, a protrusion, and a notch.

15. The crimper assembly according to any one of claims 1 to 14, wherein: During use of the crimper assembly, the second curl stop is coupled to one or both of the base and the housing at a curl stop attachment location.

16. The crimper assembly of claim 15, wherein the second crimp stop is not configured to be removed from the crimp stop attachment location without damaging the crimper assembly.

17. The crimper assembly of claim 15, wherein the second crimp stop is configured to be selectively and repeatedly coupled to and removed from the crimp stop attachment location without damaging the crimper assembly.

18. The crimper assembly of claim 15, further comprising: base; a housing fixedly mounted to the base and defining a crimper assembly central axis; and a plurality of circumferentially arrayed, nested jaws supported within the housing, wherein the jaws are radially movable within the housing toward and away from the central axis, and wherein the plurality of jaws collectively define a crimper orifice having a diameter that varies as the jaws move toward and away from the central axis; Wherein one or both of the base and the housing include a curl stop receptacle that defines the curl stop attachment location.

19. A method of mounting an implantable prosthetic valve to a valve delivery device, the method comprising: inserting a balloon catheter of the valve delivery device into a central passage of a frame of the implantable prosthetic valve; partially crimping the annular frame of the implantable prosthetic valve with a crimper assembly; operably coupling a crimp alignment tool to a distal portion of the valve delivery device to position the crimp alignment tool in an aligned configuration relative to the valve delivery device; positioning the implantable prosthetic valve to engage the crimp alignment tool; and The annular frame of the implantable prosthetic valve is fully crimped.

20. The method of claim 19, wherein the crimper assembly comprises: an actuator handle configured to be manually actuated to crimp the implantable prosthetic valve around the valve delivery device; a second curl stop that limits the overall range of motion of the actuator handle; as well as a first curl stop defining a portion of the range of motion of the actuator handle and configured to be selectively and operably coupled to the second curl stop; wherein partially curling the annular frame comprises actuating the actuator handle to engage the first curl stop with the first curl stop operably coupled to the second curl stop, wherein fully curling the annular frame comprises actuating the actuator handle to engage the second curl stop, and Wherein the method further comprises removing the first curl stop from the second curl stop after said partially curling the annular frame and before said fully curling the annular frame.

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