Artificial valve preparation assembly and related methods

Abstract

Artificial valve preparation assemblies and related methods are disclosed herein. The compressor assembly can include a first compression stop and a second compression stop that define respective movable ranges of an actuator handle. A method of attaching a transplantable artificial valve to a valve delivery device can include inserting a balloon catheter into the transplantable artificial valve, partially compressing the annular frame of the transplantable artificial valve, positioning a compression alignment tool in an alignment configuration relative to the valve delivery device, positioning the transplantable artificial valve to engage the compression alignment tool, and fully compressing the annular frame.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 368,632, filed on July 15, 2022, which is hereby incorporated by reference in its entirety.

[0002] The present disclosure relates to prosthetic valve preparation assemblies and related methods, and more particularly, to assemblies and methods that utilize an apparatus for crimping a transplantable prosthetic valve onto a delivery device.

Background Art

[0003] The human heart can be affected by various valvular diseases. These valvular diseases can cause severe heart dysfunction and may ultimately require repair of the native valve or replacement of the native valve with a prosthetic valve. There are multiple known repair devices (e.g., stents) and prosthetic valves, as well as multiple known methods for implanting these devices and valves within a human. Percutaneous and minimally invasive surgical approaches are used in various procedures to deliver medical devices to locations within the body that are not easily accessible surgically or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a compressed state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through the femoral artery and aorta) until the prosthetic heart valve reaches the implantation site within the heart. Thereafter, the prosthetic heart valve is expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, by actuating a mechanical actuator that applies an expanding force to the prosthetic heart valve, or by deploying the prosthetic heart valve from the sheath of the delivery device, such that the prosthetic heart valve can self - expand to its functional size.

Summary of the Invention

[0004] This specification discloses artificial valve preparation assemblies including compressor assemblies, valve delivery assemblies, implantable artificial valves, and compression alignment tools, as well as related methods. The disclosed artificial valve preparation assemblies and methods can ensure, for example, that an implantable artificial valve is crimped to a valve delivery device at a desired location.

[0005] The compressor assembly can include an actuator handle, a second compression stop, and a first compression stop. The actuator handle is configured to be manually actuated to compress an implantable artificial valve around a valve delivery device. The valve delivery device can include a handle and one or more shafts coupled to the handle. The second compression stop defines the full range of motion of the actuator handle, and the first compression stop defines a partial range of motion of the actuator handle. The first compression stop is configured to be selectively and operably coupled to the second compression stop.

[0006] In an exemplary embodiment, the compressor assembly further includes a base, a housing fixedly attached to the base and defining a central axis of the compressor assembly, and a plurality of circumferentially arranged nested jaws supported within the housing. The jaws are movable radially within the housing toward and away from the central axis. The plurality of jaws collectively define a compressor opening whose diameter changes as the jaws move toward and away from the central axis.

[0007] In some embodiments, the actuator handle is movable relative to the housing to move the jaws toward and away from the central axis.

[0008] In some embodiments, when the first compression stop is operably coupled to the second compression stop, the compressor opening is operated to a first stop diameter by actuating the actuator handle to engage the first compression stop.

[0009] In some embodiments, when the first compression stop is removed from the second compression stop, to engage the second compression stop, the actuator handle is actuated so that the compressor opening is sized to a second stop diameter that is smaller than the first stop diameter.

[0010] In some embodiments, the compressor assembly comprises one or more of the components recited in Examples 1-14 and / or 25-43 below.

[0011] A method of attaching a transplantable artificial valve to a valve delivery device can include inserting a balloon catheter of the valve delivery device into a central passage of a frame of the transplantable artificial valve, partially compressing the annular frame of the transplantable artificial valve with a compressor assembly, and fully compressing the annular frame of the transplantable artificial valve.

[0012] In some embodiments, the method further includes operably coupling a compression alignment tool to a distal portion of the valve delivery device to position the compression alignment tool in an alignment configuration with respect to the valve delivery device, and positioning the transplantable artificial valve to engage the compression alignment tool.

[0013] In some embodiments, the compressor assembly includes an actuator handle configured to be manually actuated to compress a transplantable artificial valve around a valve delivery device, a second compression stop defining the full range of motion of the actuator handle, and a first compression stop defining a partial range of motion of the actuator handle and configured to be selectively and operably coupled to the second compression stop.

[0014] In some embodiments, partially compressing the annular frame includes actuating the actuator handle to engage the first compression stop while the first compression stop is operably coupled to the second compression stop.

[0015] In some embodiments, completely compressing the annular frame includes actuating the actuator handle to engage the second compression stop.

[0016] In some embodiments, the method further includes removing the first compression stop from the second compression stop after partially compressing the annular frame and before completely compressing the annular frame.

[0017] In some embodiments, the method includes one or more of the steps recited in Examples 19 - 24 below.

[0018] The various innovations of the present disclosure may be used in combination or separately. The summary of the invention is provided to introduce, in a simplified form, a selection of concepts that are further described in the following detailed description of the invention. The summary of the invention is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The above and other objects, features, and advantages of the present disclosure will become more apparent from the following detailed description of the invention, the claims, and the accompanying drawings.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0020] General Considerations For the purposes of this specification, certain aspects, advantages, and novel features of the embodiments of the present disclosure are described herein. The disclosed methods, apparatuses, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, alone, in various combinations with each other, and in various sub-combinations with each other. The methods, apparatuses, and systems are not limited to any particular aspect, feature, or combination thereof, and the methods, apparatuses, and systems do not require the presence of any one or more particular advantages, nor do they require the presence of problems to be solved.

[0021] Although some operations of the disclosed embodiments are described in a particular sequential order for purposes of presentation, it should be understood that this description of the aspects is inclusive of permutations unless the specific language described below requires a particular order. For example, operations described sequentially may, in some cases, be permuted or may be performed concurrently. Additionally, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods may be used in combination with other methods. Additionally, in the description, terms such as "provide" or "achieve" are sometimes used to describe the disclosed methods. These terms are high-level abstractions related to the actual operations being performed. The actual operations corresponding to these terms may vary depending on the particular implementation and will be readily recognizable to those of ordinary skill in the art.

[0022] As used in this application and in the claims, the singular forms "a", "an", and "the" include the plural unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises". Further, the term "coupled" generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or connected, and does not exclude the presence of intervening elements between the coupled or associated members unless a specific contrary statement is made.

[0023] As used herein, the term "proximal" refers to the position, direction, or part of the device that is closer to the user and farther from the implantation site. The term "distal" as used herein refers to the position, direction, or part of the device that is farther from the user and closer to the implantation site. Thus, for example, proximal movement of the device is movement of the device away from the implantation site and toward the user (e.g., out of the patient's body), while distal movement of the device is movement of the device away from the user and toward the implantation site (e.g., into the patient's body). The terms "longitudinal direction" and "axial direction" refer to an axis extending in the proximal and distal directions unless otherwise explicitly defined. Further, the term "radial direction" refers to a direction disposed perpendicular to the axis and extending along a radius from the center of the object (where the axis is centered, such as the central longitudinal axis of the delivery assembly).

[0024] As used herein, "e.g." means "for example", and "i.e." means "that is".

[0025] Introduction to the Disclosed Technology Disclosed herein are various systems, devices, methods, etc. that include artificial valve preparation assemblies that can be used in conjunction with implantable artificial valves (e.g., transcatheter heart valves (THVs)). The various systems, devices, methods, etc. disclosed herein generally are directed to preparing an implantable artificial valve for delivery to a target implantation site through a patient's vasculature. In particular, the present disclosure relates to embodiments where the implantable artificial valve comprises an annular frame that is compressed to a reduced diameter for passage through the patient's vasculature and then expanded to an operating diameter by an inflatable balloon of a valve delivery device.

[0026] Prior to compression, a balloon-expandable implantable artificial valve typically is disposed over an inflatable balloon on a catheter shaft. If the valve is manufactured at its fully compressed diameter, the valve is expanded and then compressed onto the balloon. After the valve reaches the target implantation site within the patient's vasculature, it can be beneficial to ensure that the compression process ensures that the valve is repeatedly compressed onto the balloon at an accurate position to ensure that the balloon reliably expands the frame of the valve. Also, it can be beneficial to ensure that the compression process evenly compresses the frame of the valve without damaging the valve, while ensuring that the compressed diameter of the valve is small enough to traverse the patient's vasculature. The present disclosure addresses these needs.

[0027] The present disclosure generally is directed to embodiments of implantable valve preparation assemblies and methods of using various components of the artificial valve preparation assembly to prepare an implantable artificial valve for delivery to a target implantation site.

[0028] As shown in FIG. 1 and discussed in more detail below, the artificial valve preparation assembly 10 can include an implantable artificial valve 300, a valve delivery device 200 configured to deliver the implantable artificial valve 300 to a target implantation site, and a compression assembly 100 for compressing the implantable artificial valve around the valve delivery device.

[0029] As also shown in FIG. 1 and discussed in more detail below, the prosthetic valve preparation assembly 10 can further include a compression alignment tool 400 configured to facilitate compressing a transplantable prosthetic valve to a target compressed 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 compression alignment tool 400.

[0030] Exemplary transplantable prosthetic valves A variety of prosthetic valves are described and / or contemplated herein. Specific examples of heart valves are discussed herein, but the general structure, manufacturing methods, and methods of use of the various transplantable prosthetic valves that can be adapted for use with the devices and methods disclosed herein are described in at least U.S. Patent Nos. 9,393,110, 10,195,025, 11,013,600, and 11,185,406, the disclosures of each of which are hereby incorporated by reference in their entirety.

[0031] The prosthetic valves disclosed herein can be radially compressible and radially expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic valve can be in a radially compressed state during delivery and be compressed on or held by an implant delivery device, and then expand to a radially expanded state once the prosthetic valve reaches the implantation site. It will be understood that the prosthetic valves disclosed herein can be used with a variety of implant delivery devices and implanted via a variety of delivery techniques, examples of which are described in more detail below.

[0032] Figures 1, 11, 12, 15, 17, and 18 illustrate an example of an implantable artificial valve 300. As used herein, the implantable artificial valve 300 may also be referred to as artificial valve 300, valve 300, and / or transcatheter heart valve (THV) 300. Any of the artificial valves disclosed herein are adapted to be implanted within the native aortic valve annulus, although in other embodiments, they may be adapted to be implanted within other native valve annuli of the heart (pulmonary valve, mitral valve, and tricuspid valve). The disclosed artificial valves may also be implanted within blood vessels that communicate with the heart, including the pulmonary artery (to replace the function of a diseased pulmonary valve), or the superior or inferior vena cava (to replace the function of a diseased tricuspid valve), or various other veins, arteries, and blood vessels of a patient. The disclosed artificial valves may also be implanted within a previously implanted artificial valve (which may be an artificial surgical valve or an artificial transcatheter heart valve) in a valve-in-valve procedure.

[0033] In some embodiments, the disclosed artificial valves may be implanted within a docking or anchoring device that is implanted within a native heart valve or blood vessel. For example, in one example, the disclosed artificial valve may be implanted within a docking device implanted within the pulmonary artery to replace the function of a diseased pulmonary valve, as disclosed in the specification of U.S. Publication No. 2017 / 0231756, which is incorporated herein by reference. In another embodiment, the disclosed artificial valve may be implanted within or within a docking device implanted within the native mitral valve, as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In another example, the disclosed artificial valve may be implanted within a docking device implanted within the superior or inferior vena cava to replace the function of a diseased tricuspid valve, as disclosed in the specification of U.S. Publication No. 2019 / 0000615, which is incorporated herein by reference.

[0034] As shown in FIG. 11, the implantable artificial valve 300 includes an annular frame 310 that defines 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 to transition the implantable artificial valve 300 between a delivery configuration (see, e.g., FIGS. 17 and 18) and an operating configuration (see, e.g., FIGS. 11 and 12). Specifically, in the delivery configuration, the implantable artificial valve 300 has a sufficiently reduced diameter to be sized for delivery through a patient's vasculature. In the operating configuration, the implantable artificial valve 300 has an expanded diameter such that it can be operably mounted at a target implantation site and such that the valve assembly 320 operates to regulate blood flow within the patient. However, it should be understood that the implantable artificial valve 300 can be described as being in the operating configuration even when the implantable artificial valve 300 is not positioned within the patient and / or at the target implantation site.

[0035] The frame 310 can be made from any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol), as is known in the art. When constructed from a plastically expandable material, the frame 310 (and thus the valve 300) can be compressed into a radially compressed state on a delivery catheter and then expanded within the patient's body by an inflatable balloon or equivalent expansion mechanism. When constructed from a self-expandable material, the frame 310 (and thus the valve 300) can be compressed into a radially compressed state and constrained in the compressed state by insertion within a sheath of the delivery catheter or an equivalent mechanism. Once introduced into the body, the valve can be advanced from the delivery sheath, whereby the valve can expand to its functional size.

[0036] Suitable plastically expandable materials that can be used to form the frames disclosed herein (e.g., frame 310) include metal alloys, polymers, or combinations thereof. Exemplary metal alloys can include one or more of nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metals. In some embodiments, frame 310 can include stainless steel. In some embodiments, frame 310 can include cobalt-chromium. In some embodiments, frame 310 can include nickel-cobalt-chromium. In some embodiments, frame 310 includes a nickel-cobalt-chromium-molybdenum alloy such as MP35N (trademark) (a trade name of SPS Technologies), which is equivalent to UNS R30035 (coated by ASTM F562-02). MP35N (trademark) / UNS R30035 includes 35 wt% nickel, 35 wt% cobalt, 20 wt% chromium, and 10 wt% molybdenum.

[0037] Examples of valve delivery devices Described herein are examples of steerable delivery devices (sometimes referred to as steerable catheters and / or valve delivery assemblies) that can be used to navigate a subject's vasculature to deliver an implantable expandable medical device (e.g., an artificial heart valve), a tool, a drug, or other therapy to a location within the subject's body. Examples of procedures where a steerable catheter is useful include procedures involving neurology, urology, gynecology, fertility (e.g., in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvascular, transrectal, and access to any body tube or cavity. Specific examples include placing implants including stents, grafts, embolization coils, etc., positioning imaging devices including ultrasonic transducers and / or their components, and positioning energy sources for performing, e.g., lithotripsy, RF sources, ultrasonic emitters, electromagnetic sources, laser sources, heat sources, etc.

[0038] The valve delivery assembly according to the embodiment, and / or its components, are shown in FIGS. 1-4 and FIGS. 12-18. Although specific embodiments of the valve delivery assembly are discussed herein, the general structure and method of use of various valve delivery assemblies that can be adapted for use with the devices and methods disclosed herein are described in at least U.S. Patent Nos. 9,061,119 and 9,339,384, the disclosures of which are incorporated herein by reference in their entirety.

[0039] As shown at least in FIGS. 1-3, the valve delivery device 200 may comprise a steerable guide catheter 210 and a balloon catheter 220 (shown in FIGS. 1 and 3) extending through the guide catheter 210. As used herein, the guide catheter 210 may also be referred to as a bendable catheter 210 and / or a main catheter 210. However, it should be understood that the use of the term "main catheter" includes bendable or guide catheters, as well as other catheters that do not have the ability to bend or navigate through a patient's vasculature.

[0040] In some embodiments, such as the illustrated embodiment, the guide catheter 210 and the balloon catheter 220 are adapted to slide relative to each other in the longitudinal axis to facilitate the delivery and positioning of the implantable prosthetic valve 300 at a target implantation site within the patient's body.

[0041] As shown in FIG. 1, the guide catheter 210 includes a handle portion 212 and an elongated guide catheter shaft or tube 214 extending from the handle portion 212. The balloon catheter 220 includes a proximal portion 222 adjacent to the handle portion 212 and a balloon catheter shaft 226 extending from the proximal portion 222 through the handle portion 212 and the guide catheter shaft 214.

[0042] In some embodiments, at least as shown in FIG. 3, the balloon catheter shaft 226 can be an outer balloon catheter shaft, and the balloon catheter 220 can further include an inner balloon catheter shaft 228 that extends coaxially from the proximal portion 222 through the outer balloon catheter shaft 226 and the inflatable balloon 230. In such an embodiment, the balloon catheter 220 can include a fluid passage that is in fluid communication with an annular space defined between the inner balloon catheter shaft 228 and the outer balloon catheter shaft 226. Specifically, such a fluid passage can be fluidly connectable to a fluid source for inflating the inflatable balloon, such as to transition the implantable artificial valve 300 from a delivery configuration to an operative configuration. In the present disclosure, the operative configuration can also be referred to as a radially expanded configuration of the implantable artificial valve 300 and / or the annular frame 310.

[0043] Continuing to refer to FIGS. 1 and 3, the valve delivery device 200 further includes an inflatable balloon 230 mounted on the balloon catheter 220 at the distal portion 224 of the balloon catheter 220, which is opposite the proximal portion 222. As discussed in more detail herein, the valve delivery device 200 is generally configured such that the implantable artificial valve 300 is mounted on the valve delivery device 200 in a compressed state to prepare the valve delivery device 200 and the implantable artificial valve 300 for insertion into the patient's vasculature.

[0044] In some embodiments of a valve delivery assembly for delivering an implantable artificial valve, the valve delivery device is configured such that the implantable artificial valve is compressed at a position proximal to the inflatable balloon but removed therefrom. Such a configuration can facilitate compressing the implantable artificial valve into a relatively small outer profile, thereby facilitating delivery of the implantable artificial valve through the patient's vasculature. Use of such a system generally requires a separate step of repositioning the implantable artificial valve onto the inflatable balloon while it is inside the patient's vasculature.

[0045] In contrast, mounting a transplantable artificial valve directly onto an inflatable balloon before it enters the patient's vasculature can improve the reliability and ease of implanting the transplantable artificial valve at the target implantation site. Thus, the devices and methods disclosed herein can be used to compress a transplantable artificial valve 300 at an accurate target compression position relative to a valve delivery device 200 onto an inflatable balloon 230 having a tightly compressed outer shape.

[0046] In some embodiments, at least as shown in FIG. 3, the valve delivery device 200 includes a nose piece 240 attached to the distal end of the valve delivery device 200 to facilitate advancement of the valve delivery device 200 through the patient's vasculature to the target implantation site. In some cases, it may be useful to have a nose piece 240 connected to a separate elongate shaft such that the nose piece 240 can move independently of other elements of the valve delivery device 200. The nose piece 240 can be formed of any of a variety of materials, including various polymers, metals, and / or composite materials.

[0047] In some embodiments, at least as shown in FIG. 3, the valve delivery device 200 further includes a stylet 250 configured to be removably coupled to the distal end of the nose piece 240. More specifically, as shown in FIG. 3, the nose piece 240 can include a nose piece lumen 242, and the stylet 250 can include a stylet shaft 252 (e.g., a rigid and / or metal shaft) configured to be received within the nose piece lumen 242 to selectively couple the stylet 250 to the nose piece 240.

[0048] In some embodiments, the stylet 250 is more rigid than the nose piece 240. In particular, the nose piece 240 can be formed of a material that is sufficiently elastic and / or conformable to allow the nose piece 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 nose piece 240 defines the distal end or tip of the valve delivery device 200 when the valve delivery device 200 is moved through the patient's vasculature. However, as will be described in more detail herein, operably coupling the relatively rigid stylet 250 to the nose piece 240 can facilitate securely positioning the implantable artificial valve 300 at a target compression position on the inflatable balloon 230 prior to introducing the valve delivery device 200 into the patient's vasculature.

[0049] As used herein to describe the configuration and / or relationship between two or more components, the term "operably coupled" is intended to refer to a configuration and / or relationship in which components are directly or indirectly coupled to one another in a manner consistent with the structures and / or functions disclosed herein. For example, a pair of components can be described as being operably coupled to one another if such components are coupled to one another in a manner operable to produce the structural configurations and / or functional characteristics disclosed herein.

[0050] Examples of Delivery Techniques For implanting an artificial valve within the native aortic valve via a transfemoral delivery approach, the artificial valve is mounted in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral artery and advanced through the descending aorta and through the aortic arch and through the ascending aorta and around the aortic arch. The artificial valve is positioned within the native aortic valve and expanded radially (e.g., by inflating a balloon, by actuating one or more actuators of the delivery device, or by deploying the artificial valve from a sheath to make the artificial valve self-expanding). Alternatively, the artificial valve may be implanted within the native aortic valve via a transapical procedure, in which case the artificial valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the artificial valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, the artificial valve (on the distal end portion of the delivery device) is introduced into the aorta through a surgical incision in the ascending aorta, for example, by a partial J sternotomy or a mini-thoracotomy right parasternal, and then advanced through the ascending aorta toward the native aortic valve.

[0051] For implanting an artificial valve within the native mitral valve via a transseptal delivery approach, the artificial valve is mounted in a radially compressed state along the distal end portion of the delivery device. The artificial valve and the distal end portion of the delivery device are inserted into the femoral vein and advanced through the inferior vena cava and through the inferior vena cava to the right atrium, across the atrial septum (through a puncture made within the atrial septum), to the left atrium, and toward the native mitral valve. Alternatively, the artificial valve may be implanted within the native mitral valve via a transapical procedure, whereby the artificial valve (on the distal end portion of the delivery device) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart, and the artificial valve is positioned within the native mitral valve.

[0052] To implant an artificial valve within a native tricuspid valve, the artificial valve is mounted in a radially compressed state along a distal end portion of a delivery device. The artificial valve and the distal end of the delivery device are inserted into the femoral vein and advanced through the inferior vena cava and into the right atrium, where the artificial valve is positioned within the native tricuspid valve. A similar approach can be used to implant an artificial valve within a native pulmonary valve or within the pulmonary artery, except that the artificial valve is advanced through the native tricuspid valve and into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0053] Another delivery approach is a transatrial approach, in which the artificial valve (on the distal end of the delivery device) is inserted through an incision in the chest wall and through an incision created through the atrial wall (right atrium or left atrium) to access either the native heart valve. Atrial delivery can also be performed intravascularly, for example, from a pulmonary vein. Yet another delivery approach is a transventricular approach, in which the artificial valve (on the distal end portion of the delivery device) is inserted through an incision in the chest wall and through an incision created through the wall of the right ventricle (typically at or near the base of the heart) to implant the artificial valve within the native tricuspid valve, within the native pulmonary valve, or within the pulmonary artery.

[0054] In all delivery approaches, the delivery device can be advanced over a guidewire previously inserted into the patient's vasculature. Moreover, the disclosed delivery approaches are not intended to be limiting. Any artificial valve disclosed herein can be implanted using any of a variety of delivery techniques and delivery devices known in the art.

[0055] Example of a Compression Assembly As discussed herein, the prosthetic valve preparation assembly 10 generally includes a compressor assembly 100 for compressing a prosthetic valve 300 that can be implanted on an inflatable balloon 230. The compressor assembly according to some embodiments, and / or its components, are shown in FIGS. 1, 7-10, 13 and 14, and FIG. 16. Specific embodiments of the compressor assembly are considered herein, but the general structure and method of use of various compressor assemblies that can be adapted for use with the devices and methods disclosed herein are described at least in U.S. Patent No. 7,530,253, the disclosure of which is hereby incorporated by reference in its entirety.

[0056] As shown at least in FIGS. 1 and 13, the compressor assembly 100 can include a base 112, a housing 110 fixedly attached to the base 112, and a plurality of circumferentially arranged nested jaws 114 (labeled in FIG. 1) supported within the housing 110. More specifically, the housing 110 defines a central axis 102 of the compressor assembly, and the jaws 114 are movable radially within the housing 110 toward and away from the central axis 102 of the compressor assembly. The jaws 114 collectively define a compressor opening 130 whose diameter changes as the jaws 114 move toward and away from the central axis 102 of the compressor assembly.

[0057] The compressor assembly 100 further includes an actuator handle 120 configured to be manually actuated to move the jaw portion 114 so as to change the diameter of the compressor opening 130. Specifically, in the illustrated embodiment, the actuator handle 120 can be pivoted in a first direction relative to the housing 110 to move the jaw portion 114 radially toward the central axis 102 of the compressor assembly, and the actuator handle 120 can be pivoted in a second direction opposite the first direction relative to the housing 110 to move the jaw portion 114 radially away from the central axis 102 of the compressor assembly. Thus, when the implantable artificial valve 300 is positioned within the compressor opening 130, the actuator handle 120 can be actuated to compress the implantable artificial valve 300 so as to reduce the diameter of the compressor opening 130.

[0058] In some embodiments, the compressor opening 130 extends along a compressor opening length that is greater than or equal to the valve length 302 of the implantable artificial valve 300, measured along a direction parallel to the central axis 102 of the compressor assembly (as shown in FIG. 12). Thus, in such embodiments, the implantable artificial valve 300 can be fully positioned within the compressor opening 130 such that the compressor assembly 100 exerts a uniform compressive force over the entire length of the implantable artificial valve 300.

[0059] When the compressor assembly 100 is utilized to fully compress the implantable artificial valve 300 into a delivery configuration, the implantable artificial valve 300 can engage closely enough with the inflatable balloon 230 such that translation of the implantable artificial valve 300 relative to the inflatable balloon 230 is restricted. Thus, it is desirable to ensure that the implantable artificial valve 300 is properly positioned at the target compression position before fully compressing the implantable artificial valve 300 onto the inflatable balloon 230.

[0060] As used herein, the term "target compression position" is intended to refer to any suitable axial position and / or range of positions along the inflatable balloon 230 to which the implantable artificial valve 300 is operably coupled. As an example, the target compression position may include, and / or may be, the axial position along the inflatable balloon 230 where the distal end of the implantable artificial valve 300 is located when the implantable artificial valve 300 is properly compressed against the inflatable balloon 230. As another example, the target compression position may include, and / or may be, the axial position along the inflatable balloon 230 where the proximal end of the implantable artificial valve 300 is located when the implantable artificial valve 300 is then properly compressed against the inflatable balloon 230. As yet another example, the target compression position may refer to a portion (e.g., interval) of the length of the inflatable balloon 230 within which the implantable artificial valve 300 is positioned when the implantable artificial valve 300 is properly compressed against the inflatable balloon 230.

[0061] Positioning the implantable artificial valve 300 at the target compression location with a high degree of precision and / or accuracy can facilitate predictable deployment at the target implantation site of the implantable artificial valve 300. In particular, in some embodiments, positioning the implantable artificial valve 300 at the target implantation site is accomplished by positioning one or more components of the valve delivery device 200 at known, measurable, and / or controlled positions and / or orientations relative to the patient's anatomy. Thus, in such embodiments, controlling the position of the implantable artificial valve 300 relative to the delivery device 200 with a high degree of precision and / or accuracy can be beneficial in controlling the position and / or orientation of the implantable artificial valve 300 relative to the target implantation site.

[0062] Furthermore, in some embodiments, the shape of the implantable prosthetic valve 300 after being radially expanded by the inflatable balloon 230 is sensitive to the position where the implantable prosthetic valve 300 is compressed onto the inflatable balloon 230. Thus, in such embodiments, controlling the position of the implantable prosthetic valve 300 relative to the delivery device 200 (e.g., relative to the inflatable balloon 230) with a high degree of precision and / or accuracy can be beneficial to ensure that the implantable prosthetic valve 300 assumes the intended shape when being radially expanded by the inflatable balloon 230 into the operative configuration at the target implantation site.

[0063] The devices and methods disclosed herein can facilitate and / or enable compressing the implantable prosthetic valve 300 at the target compression location with any suitable degree of precision and / or accuracy. In particular, in some embodiments, the devices and methods disclosed herein can consistently achieve a compression accuracy of about 1.0 millimeter (mm) to 1.5 millimeters (mm) relative to the target compression position. In some such embodiments, the target compression position corresponds to a well-defined position and / or mechanism of the valve delivery device 200, such as a portion of the nose piece 240 and / or the distal portion of the balloon catheter 220.

[0064] When the implantable prosthetic valve 300 is in the operative configuration and positioned near the target compression position, the diameter of the frame central passage 314 may be large enough for the implantable prosthetic valve 300 to engage loosely and / or only tangentially with the valve delivery device 200. Thus, even if the implantable prosthetic valve 300 in the operative configuration is properly positioned at the target compression location before fully compressing the implantable prosthetic valve 300, the compression action (and / or the axial translation of the valve delivery device 200 during the compression action) can cause the implantable prosthetic valve 300 to shift to a position away from the target compression position.

[0065] Thus, it may be desirable to partially compress the implantable prosthetic valve 300 into an intermediate configuration before fully compressing the implantable prosthetic valve 300 into a delivery configuration. Specifically, in such an embodiment, the implantable prosthetic valve 300 in the intermediate configuration can be manually translated relative to the inflatable balloon 230, but is sized (e.g., by inner diameter) to engage the valve delivery device 200 and / or the inflatable balloon 230 such that the implantable prosthetic valve 300 is at least partially restricted from inadvertent translation relative to the inflatable balloon 230. In this way, compressing the implantable prosthetic valve 300 into the intermediate configuration and then positioning the implantable prosthetic valve 300 at the target compression position can ensure that the implantable prosthetic valve 300 remains at the target compression position during the final compression actuation.

[0066] In some embodiments, compressing the implantable prosthetic valve 300 into the intermediate or delivery configuration is achieved by setting the diameter of the compressor aperture 130 to a corresponding predetermined diameter. This can then be achieved by mechanically restricting the range of motion of the actuator handle 120 during use of the compressor assembly 100.

[0067] More specifically, as shown in FIGS. 1, 7-10, 13 and 14, and FIG. 16, and as discussed in more detail below, the compressor assembly 100 can include a first compression stop 150 (examples of which are shown in FIGS. 1, 7-8C, 10, and 13 and 14) and a second compression stop 170 (shown in FIGS. 1, 7, 9A-10, 13 and 14, and FIG. 16), each of which can be utilized to define a respective range of motion of the actuator handle 120. The second compression stop 170 can be fixedly coupled to the housing 110 during use of the compressor assembly 100, and the first compression stop 150 can be selectively and operably coupled to the second compression stop 170. In particular, as described in more detail herein, the first compression stop 150 is configured to be mechanically coupled to the second compression stop 170.

[0068] In some embodiments, the first compression stop portion 150 and the second compression stop portion 170 may be described as representing components of the compression stop assembly 140 of the compressor assembly 100. In particular, FIGS. 1, 7-8c, and 13 and 14 show a first embodiment of the compression stop assembly 140a including a first embodiment of the first compression stop portion 150a in combination with the second compression stop portion 170, while FIG. 10 shows a second embodiment of the compression stop assembly 140b including a second embodiment of the first compression stop portion 150b in combination with the second compression stop portion 170.

[0069] In the present disclosure, unless otherwise stated (e.g., referring to a particular illustrated embodiment), references to the compression stop assembly 140 may be understood to relate to and / or refer to either and / or both of the compression stop assembly 140a of the first embodiment and / or the compression stop assembly 140b of the second embodiment. Similarly, in the present disclosure, unless otherwise stated (e.g., referring to a particular illustrated embodiment), references to the first compression stop portion 150 may be understood to relate to and / or refer to either and / or both of the first compression stop portion 150a of the first embodiment and / or the first compression stop portion 150b of the second embodiment. Thus, in the present disclosure, like numbers are used to refer to like components of the various embodiments of the compression stop assembly 140 and / or the first compression stop portion 150, although each such number may not be specifically described and / or explicitly referenced herein.

[0070] When the first compression stop portion 150 is operably coupled to the second compression stop portion 170, the first compression stop portion 150 and the second compression stop portion 170 may collectively define a partial movement range of the actuator handle 120. That is, when the first compression stop portion 150 is operably coupled to the second compression stop portion 170, the actuator handle 120 may be actuated to reduce the diameter of the compressor opening 130 only until the actuator handle 120 engages the first compression stop portion 150, at which point the actuator handle 120 is mechanically limited and / or prevented from further actuation in this direction.

[0071] FIG. 14 shows an embodiment in which a transplantable artificial valve 300 and a valve delivery device 200 (not visible in FIG. 14) are positioned within a compressor opening 130 and an actuator handle 120 is actuated to engage a first compression stop 150. As shown in FIG. 14, when the actuator handle 120 engages the first compression stop 150, the compressor opening 130 can be described as having a first stop diameter 132 corresponding to an intermediate configuration of the transplantable artificial valve 300. That is, when the transplantable artificial valve 300 is positioned within the compressor opening 130 and the actuator handle 120 engages the first compression stop 150, the compressor opening 130 is compressed to the intermediate configuration as a result of the transplantable artificial valve 300 being brought to the first stop diameter 132. As a result, the outer diameter of the transplantable artificial valve 300 may be at least substantially equal to the first stop diameter 132 when the transplantable artificial valve is in the intermediate configuration.

[0072] When the first compression stop 150 is removed from the second compression stop 170, the second compression stop 170 can define the full range of motion of the actuator handle 120. That is, when the first compression stop 150 is removed from the second compression stop 170 and the second compression stop 170 is fixedly coupled to the housing 110, the actuator handle 120 can be actuated to reduce the diameter of the compressor opening 130 only until the actuator handle 120 engages the second compression stop 170, at which point the actuator handle 120 is mechanically limited and / or prevented from further actuation in this direction.

[0073] FIG. 16 shows an embodiment where a transplantable artificial valve 300 and a valve delivery device 200 (not visible in FIG. 16) are positioned within a compressor opening 130 and an actuator handle 120 is actuated to engage a second compression stop 170. As shown in FIG. 16, when the actuator handle 120 engages the second compression stop, the compressor opening 130 can be described as corresponding to the delivery configuration of the transplantable artificial valve 300 and having a second stop diameter 134 that is smaller than a first stop diameter 132. That is, when the transplantable artificial valve 300 is positioned within the compressor opening 130 and the actuator handle 120 engages the second compression stop 170, the transplantable artificial valve 300 is compressed into the delivery configuration as a result of the compressor opening 130 assuming the second stop diameter 134. As a result, the outer diameter of the transplantable artificial valve 300 may be at least substantially equal to the second stop diameter 134 when the transplantable artificial valve is in the delivery configuration.

[0074] In the embodiments disclosed herein, the first compression stop 150 can be utilized during an initial step utilized to compress the implantable prosthetic valve 300 of the compressor assembly 100, and / or the second compression stop 170 can be utilized during a final step utilized to compress the implantable prosthetic valve 300 of the compressor assembly 100. Thus, in such embodiments, the first compression stop 150 can be additionally or alternatively referred to as the initial compression stop 150, and / or the second compression stop 170 can be additionally or alternatively referred to as the final compression stop 170. Similarly, in such embodiments, the first stop diameter 132 can be additionally or alternatively referred to as the initial stop diameter 132, and / or the second stop diameter 134 can be additionally or alternatively referred to as the final stop diameter 134. However, such embodiments are not limiting, and additionally, within the scope of the present disclosure, the compression stop assembly 140 may further include additional compression stops such as a third compression stop, a fourth compression stop, and the like. In such embodiments, a plurality of compression stops (and / or subsets thereof) can be coupled to each other in various combinations to define respective ranges of motion of the actuator handle 120 and / or to generate respective diameters of the compressor opening 130.

[0075] The first compression stop 150 and the second compression stop 170 may each have any of a variety of mechanisms and / or configurations for demonstrating the functionality disclosed herein. FIGS. 8A-8C illustrate a first embodiment of the first compression stop 150a, while FIGS. 9A-9C illustrate an embodiment of the second compression stop 170. FIG. 7 shows the first compression stop 150a of FIGS. 8A-8C operably coupled to the second compression stop 170 of FIGS. 9A-9C, while FIG. 10 shows another embodiment of the first compression stop 150b operably coupled to the second compression stop 170 of FIGS. 9A-9C.

[0076] In some embodiments, at least as shown in FIGS. 7 to 8C, the first compression stop portion 150 defines a terminal end 160 of the first compression stop portion and includes a body 158 of the first compression stop portion (e.g., the body 158a of the first compression stop portion shown in FIGS. 7 to 8C) that terminates at the terminal end 160 of the first compression stop portion. In such an embodiment, the compressor assembly 100 is configured such that the actuator handle 120 engages the terminal end 160 of the first compression stop portion during use of the compressor assembly 100 to partially compress the implantable artificial valve 300.

[0077] Similarly, in some embodiments, at least as shown in FIGS. 7 and 9A to 9C, the second compression stop portion 170 defines a terminal end 174 of the second compression stop portion and includes a body 172 of the second compression stop portion that terminates at the terminal end 174 of the second compression stop portion. In such an embodiment, the compressor assembly 100 is configured such that the actuator handle 120 engages the terminal end 174 of the second compression stop portion during use of the compressor assembly 100 to fully compress the implantable artificial valve 300.

[0078] The first compression stop portion 150 and / or the second compression stop portion 170 may additionally have any of a variety of mechanisms to facilitate operably coupling the first compression stop portion 150 to the second compression stop portion 170. For example, in some embodiments, as shown in FIGS. 7 to 8C, the first compression stop portion 150 includes a second compression stop receiver 154 (e.g., the second compression stop receiver 154a shown in FIGS. 7 to 8C) configured to receive a portion of the second compression stop portion 170, such as the body 172 of the second compression stop portion and / or the terminal end 174 of the second compression stop portion, when the first compression stop portion 150 is operably coupled to the second compression stop portion 170. As a more specific example, the second compression stop receiver 154 may include a receiver channel 156 (the receiver channel 156a shown in FIGS. 7 to 8C) for receiving an elongate portion of the second compression stop portion 170 to mechanically couple the first compression stop portion 150 to the second compression stop portion 170 and / or may be the receiver channel 156.

[0079] In some embodiments, the internal geometry of the first compression stop 150 (e.g., the receiver channel 156) is configured to receive the upper portion of the second compression stop 170 of the mating configuration (e.g., the portion including the end 174 of the second compression stop). For example, the receiver channel 156 may have a shape similar to the upper portion of the second compression stop 170 such that the first compression stop 150 can be snapped onto the second compression stop 170. Such mechanical engagement can also serve to prevent the first compression stop 150 from being inadvertently removed from the second compression stop 170.

[0080] Additionally or alternatively, in some embodiments, such as the embodiments of FIGS. 7-8C, the first compression stop 150 includes a gripping mechanism 152 (e.g., the gripping mechanism 152a shown in FIGS. 7-8C) configured to facilitate removal of the first compression stop 150 from the second compression stop 170. In particular, when present, the gripping mechanism 152 may be configured to be gripped by a user to apply torque to the first compression stop 150 and / or to enable the user to pull the first compression stop 150 away from the second compression stop 170. The gripping mechanism 152 may include various structures and / or may be any of them, and examples of such include tabs, levers, protrusions, and depressions. In some embodiments, the gripping mechanism 152 is at least partially defined by the body 158 of the first compression stop.

[0081] A second embodiment of the first compression stop portion 150b shown in FIG. 10 is substantially similar to the first embodiment of the first compression stop portion 150a shown in FIGS. 7-8C, except that the body 158b of the first compression stop portion additionally defines an upper recess 159 to which the receiver channel 156b is connected (e.g., open). In particular, as shown in FIG. 10, when the first compression stop portion 150b is coupled to the second compression stop portion 170, the body 172 of the second compression stop portion occupies the receiver channel 156b but does not occupy the upper recess 159, which is then positioned between the end 160b of the first compression stop portion and the end 174 of the second compression stop portion. Such a configuration can facilitate bending of the body 158b of the first compression stop portion, such as when pulling and / or applying torque to the gripping mechanism 152b to remove the first compression stop portion 150b from the second compression stop portion 170.

[0082] As described above, the compressor assembly 100 is generally configured such that the second compression stop portion 170 is fixedly coupled to the housing 110 during use of the compressor assembly 100. In particular, as shown in FIG. 13, during use of the compressor assembly 100, the second compression stop portion 170 can be coupled to the base 112 and / or the housing 110 at a compression stop attachment location 118 defined by the base 112 and / or the housing 110.

[0083] In some embodiments, the base 112 and / or the housing 110 may include a compression stop receiver 116 that defines the compression stop attachment location 118. In such embodiments, the compression stop receiver 116 may include and / or be any suitable structure and / or mechanism for fixedly holding the second compression stop portion 170, and examples thereof include friction fit connections, snap fit connections, latch connections, key connections, and the like.

[0084] In some embodiments, the second compression stop 170 may be permanently or semi - permanently attached to the compression stop attachment location 118. In other words, in such embodiments, the second compression stop 170 may not be configured to be removed from the compression stop attachment location 118 without damaging the compressor assembly 100. However, this is not necessary for all embodiments of the compressor assembly 100, and additionally, it is within the scope of the present disclosure that the second compression stop 170 may be configured to be selectively and / or temporarily attached to the compression stop attachment location 118. In other words, in some embodiments, the second compression stop 170 may be configured to be selectively and repeatedly coupled to and removed from the compression stop attachment location 118 without damaging the compressor assembly 100.

[0085] Embodiments of a compression alignment tool As described above, generally, it is desirable to ensure that the implantable prosthetic valve 300 is accurately and reliably positioned at a target compression position relative to the inflatable balloon 230 before fully compressing the implantable prosthetic valve 300 onto the inflatable balloon 230. Thus, as shown at least in FIGS. 2 - 4, FIGS. 6A - 6D, and FIG. 15, the prosthetic valve preparation assembly 10 may include a compression alignment tool 400 configured to facilitate positioning the implantable prosthetic valve 300 at the target compression position.

[0086] The compression alignment tool 400 can be utilized 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 corresponding to the target compression position. Specifically, as discussed in more detail herein, the compression 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 compression position relative to the valve delivery device 200.

[0087] As described above, when the implantable artificial valve 300 is in an intermediate configuration (e.g., after being partially compressed by the compressor assembly 100), the implantable artificial valve 300 can be manually translated along the length of the valve delivery device 200 and / or the inflatable balloon 230, or otherwise, inadvertent translation with respect to the valve delivery device 200 can be restricted. Thus, in some embodiments, the compression alignment tool 400 is utilized to position the implantable artificial valve 300 while the implantable artificial valve 300 is in the intermediate configuration.

[0088] The compression alignment tool 400 can have any of a variety of features and / or mechanisms for engaging the valve delivery device 200 and / or the implantable artificial valve 300. In some embodiments, as shown at least in FIGS. 3, 6B, and 6D, the compression alignment tool 400 includes a catheter receiver 440 configured to receive the distal portion of the valve delivery device 200. In particular, the compression alignment tool 400 is configured such that when the distal portion of the valve delivery device 200 is operably received within the catheter receiver 440 (as described herein), the compression alignment tool 400 can be described as being in an aligned configuration with respect to the valve delivery device 200.

[0089] The aligned configuration of the compression alignment tool 400 can be described and / or defined with reference to the relative orientation and / or mechanical engagement between the compression alignment tool 400 and the valve delivery device 200. In particular, as described in more detail herein, the compression alignment tool 400 can include a distal end 420 of the compression alignment tool configured to engage the distal portion of the valve delivery device 200 to define the aligned configuration and / or to hold the compression alignment tool 400 in the aligned configuration.

[0090] When the compression alignment tool 400 is in an aligned configuration with respect to the valve delivery device 200, the position of the compression alignment tool 400 can be utilized to place the implantable artificial valve 300 in the target compression position. In particular, as shown in FIGS. 3, 6A - 6D, and 15, the compression alignment tool 400 includes a valve stop 412 positioned within the proximal region 410 of the compression alignment tool 400.

[0091] As shown in FIG. 15, the valve stop portion 412 is configured to engage the distal frame end 312 of the annular frame 310 of the implantable artificial valve 300. Specifically, the compression alignment tool 400 is configured such that when the compression alignment tool 400 is in an alignment configuration where the distal end 420 of the compression alignment tool engages the distal portion of the valve delivery device 200, the implantable artificial valve 300 is positioned so that the distal frame end 312 engages the valve stop portion 412, and then the implantable artificial valve 300 is operated to be positioned at the target compression position. As will be discussed in more detail below, the valve stop portion 412 may comprise and / or be a structure defined by the compression alignment tool 400, such as its annular surface and / or its end edge.

[0092] The compression alignment tool 400 may be configured to engage the valve delivery device 200 in the alignment configuration in any of a variety of manners. In some embodiments, the compression alignment tool 400 may be moved axially (e.g., via axial translation) on the distal portion of the valve delivery device 200 to operably couple the compression alignment tool 400 to the valve delivery device 200. Similarly, in such embodiments, the compression alignment tool 400 may be removed from the valve delivery device 200 by sliding the compression alignment tool 400 axially out of and away from the valve delivery device 200.

[0093] In some embodiments, the compression alignment tool 400 may be configured to limit and / or prevent inadvertent removal of the compression alignment tool 400 from the valve delivery device 200. For example, the compression alignment tool 400 may be configured such that when the compression alignment tool 400 is in the alignment configuration, removal of the compression alignment tool 400 from the valve delivery device 200 is at least partially restricted. As a more specific example, the compression alignment tool 400 may be configured to engage the distal portion of the valve delivery device by a friction fit engagement, a mechanical engagement, a latch engagement, a snap fit engagement, or the like.

[0094] In some embodiments, by positioning the compression alignment tool 400 in the alignment configuration, haptic and / or auditory confirmations such as snaps, pops, bumps, etc. can be generated indicating that the compression alignment tool has reached the alignment configuration. Such haptic and / or auditory confirmations can be the result of forming mechanical couplings such as latch engagement, detent engagement / reception, protrusion or groove engagement / reception, etc.

[0095] The compression alignment tool 400 can be configured to receive and / or engage any suitable portion of the valve delivery device 200 to define and / or hold the compression alignment tool 400 in the alignment configuration. In some embodiments, as shown in FIGS. 2, 4, and 15, the compression alignment tool 400 is configured such that when the compression alignment tool 400 is in the alignment configuration, the stylet 250 of the valve delivery device 200 engages the distal end 420 of the compression alignment tool. In such embodiments, the compression alignment tool 400 can be configured such that when the compression alignment tool 400 is in the alignment configuration, the inner diameter of the compression alignment tool 400 mates with the outer diameter of the stylet 250.

[0096] In particular, as described above, the stylet 250 can be formed of a material that is more rigid than the nose piece 240, and thus can provide a reliable reference point for measuring the axial distance relative to the expandable balloon 230. For example, when the stylet 250 is formed of a relatively rigid material, such rigidity can facilitate establishing an accurate and / or well-defined positional relationship between the stylet 250 and the compression alignment tool 400.

[0097] More specifically, in some embodiments, the stylet shaft 252 extends into the nose piece 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 embodiments, when the stylet 250 is operably coupled to the nose piece 240, the axial force applied to the stylet 250 can be transmitted to the balloon catheter 220 via the stylet shaft 252. Since the axial position of the distal end of the balloon catheter 220 is substantially fixed relative to the inflatable balloon 230 (and thus relative to the target compression position), the stylet 250 itself can function as a reference position for positioning the target compression position. That is, the stylet 250 and / or the stylet shaft 252 are sized such that when the stylet shaft 252 engages the distal end of the balloon catheter 220 via the nose piece lumen 242, and when the compression alignment tool 400 receives and engages the stylet 250, the valve stop 412 aligns with the target compression position (and / or its distal end). In this way, such a configuration can facilitate establishing an accurate and substantially constant axial positional relationship between the compression alignment tool 400 and the target compression position, and thus ensure that the compression alignment tool 400 can be utilized to properly position the implantable prosthetic valve 300.

[0098] In some embodiments, at least as shown in FIG. 4, the distal end 420 of the compression alignment tool includes a distal opening 422 that receives the distal portion of the valve delivery device 200 (e.g., the stylet 250) when the compression alignment tool is in the aligned configuration.

[0099] In particular, in some such embodiments, the compression alignment tool 400 can be configured such that when the compression alignment tool 400 is in the aligned configuration, the stylet 250 extends at least partially through the distal opening 422. In this way, the engagement between the distal opening 422 and the stylet 250 can at least partially define the aligned configuration.

[0100] For example, the stylet 250 can be at least partially conical such that the stylet 250 engages the distal opening 422 (i.e., a portion of the compression alignment tool 400 that defines the distal opening 422) only when the stylet 250 is in an accurate and predetermined axial position relative to the compression alignment tool 400.

[0101] In some embodiments, the compression alignment tool 400 can include a distal alignment indicator 424 in the form of one or more mechanisms for visually verifying that the compression alignment tool 400 is in an aligned configuration. For example, in some embodiments, as shown in FIGS. 2-4, 6A-6D, and 15, the distal alignment indicator 424 includes a window 426 that enables visual inspection of the valve delivery device 200 by the compression alignment tool 400. That is, in such embodiments, the window 426 can be an opening and / or aperture formed in the sidewall of the compression alignment tool 400 such that a portion of the valve delivery device 200 received within the compression alignment tool 400 is visible through the window 426.

[0102] In some embodiments, the compression alignment tool 400 is configured such that when the compression alignment tool is in an aligned configuration, components of the valve delivery device are axially aligned with the distal edge and / or the proximal edge of the window 426. In particular, in some embodiments, as shown at least in FIG. 15, the window 426 is positioned such that when the compression alignment tool 400 is in an 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 compression alignment tool 400 is in an aligned configuration by visually verifying that the proximal edge of the stylet 250 is axially aligned with the distal edge of the window 426.

[0103] Additionally or alternatively, in some embodiments, as schematically shown in FIG. 6C, the distal alignment indicator 424 may comprise one or more visual indicia 428 that provide another visual indicator that the compression alignment tool 400 is in an aligned configuration. For example, the visual indicia 428 may be configured such that when the compression alignment tool 400 is in an 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. By way of example, the visual indicia 428 may include and / or be marks, color marks, printed marks, embossed marks, debossed marks, lines, symbols, etc.

[0104] The compression alignment tool 400 may be configured to engage the implantable prosthetic valve 300 to position the implantable prosthetic valve 300 in any suitable manner at a target compression location. In some embodiments, at least as shown in FIGS. 6A - 6C, the compression alignment tool 400 includes a proximal end 414 of the compression alignment tool that defines a valve stop 412 and / or terminates at the proximal end 414 of the compression alignment tool that defines the valve stop 412. In other words, in such embodiments, the distal frame end 312 is positioned to engage and / or abut against the proximal end 414 of the compression alignment tool while the compression alignment tool 400 is in an aligned configuration to position the implantable prosthetic valve at the target compression position.

[0105] However, this is not required for all embodiments of the compression alignment tool. For example, it is additionally within the scope of the present disclosure for the compression alignment tool 400 to be configured to at least partially axially overlap with the implantable prosthetic valve 300 to position the implantable prosthetic valve 300 at a target compression position. As a more specific example, as schematically shown in FIG. 6D, the compression alignment tool 400 may comprise a stepped inner surface that defines the 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 compression alignment tool 400.

[0106] Example of balloon cover assembly In some embodiments, the prosthetic valve preparation assembly 10 may further comprise one or more mechanisms for preserving the shape and / or configuration of the valve delivery device 200 and / or the compression alignment tool 400 before compressing the implantable prosthetic valve 300 onto the inflatable balloon 230. For example, in some embodiments, as shown in FIGS. 2-5D, the prosthetic valve preparation assembly 10 comprises a balloon cover assembly 450 configured to be operably coupled to the inflatable balloon 230 to shape and / or protect the inflatable balloon 230, etc., before preparing the valve delivery device 200 to be deployed within the patient's vasculature. More specifically, as will be described in more detail herein, the balloon cover assembly 450 may be configured to cover and / or engage the inflatable balloon 230 to protect the inflatable balloon 230 from damage or mis-shaping, etc., during transfer to the user.

[0107] In some embodiments, as shown in FIGS. 2-5D, the balloon cover assembly 450 may comprise a pair of balloon cover clam shell portions 460a and 460b configured to be attached to opposite sides of the inflatable balloon 230 when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230. In particular, FIG. 2 shows the balloon cover clam shell portions 460a and 460b operably coupled to the inflatable balloon 230, and FIGS. 3 and 4 show the balloon cover clam shell portions 460a and 460b removed from the inflatable balloon 230. As discussed below, FIGS. 5A-5C show the balloon cover clam shell portions 460a and / or 460b in more detail. In the present disclosure, the balloon cover clam shell portion 460a may also be referred to as the first balloon cover clam shell portion 460a, and / or the balloon cover clam shell portion 460b may also be referred to as the second balloon cover clam shell portion 460b.

[0108] The balloon cover crimp shell portions 460a and 460b can collectively engage the inflatable balloon 230 to maintain the balloon cover assembly 450 in a fixed position relative to the inflatable balloon 230 and / or to maintain the shape of the inflatable balloon 230, etc. Each of the balloon cover crimp shell portions 460a and 460b, as used herein, may be described as representing respective examples of the balloon cover crimp shell portion 460.

[0109] In some embodiments, the balloon cover assembly 450 further comprises one or more mechanisms to limit removal of the balloon cover crimp shell portions 460a and 460b from the inflatable balloon 230. In particular, in some embodiments, as shown in FIGS. 2 and 3, the balloon cover assembly 450 comprises a balloon cover sleeve 452 configured to surround the balloon cover crimp shell portions 460a and 460b and hold the balloon cover crimp shell portions 460a and 460b against the inflatable balloon 230. In other words, when the balloon cover assembly 450 is operatively coupled to the inflatable balloon 230 and the balloon cover crimp shell portions 460a and 460b are received within the balloon cover sleeve 452, the balloon cover sleeve 452 can limit and / or prevent the balloon cover crimp shell portions 460a and 460b from being removed from the inflatable balloon 230 until the balloon cover shell portion 452 is removed from the balloon cover crimp shell portions 460a and 460b.

[0110] In some embodiments, with particular reference to FIGS. 2, 3, and 5A, balloon cover column shell portions 460a and 460b, when operatively coupled to the inflatable balloon 230, collectively form a cylindrical outer surface, and the balloon cover sleeve 452 (shown in FIG. 3) has a cylindrical inner surface that receives and engages the balloon cover column shell portions 460a and 460b. In this way, in this embodiment, the balloon cover sleeve 452 can be attached onto and removed from the balloon cover column shell portions 460a and 460b by sliding the balloon cover sleeve 452 axially over and outside the balloon cover column shell portions 460a and 460b.

[0111] However, such a configuration is not required, and furthermore, it is within the scope of the present disclosure that the balloon cover sleeve 452 can have any suitable form for engaging the balloon cover column shell portions 460a and 460b. For example, the balloon cover column shell portions 460a and 460b and the balloon cover sleeve 452 can each have mating surfaces that engage each other (e.g., via a friction interface and / or a mechanical coupling) to limit, for example, the inadvertent removal of the balloon cover sleeve 452 from the balloon cover column shell portions 460a and 460b.

[0112] Each of the balloon cover crimp shell portions 460a and 460b can be configured to engage a balloon 230 that is inflatable in any of a variety of configurations. In some embodiments, at least as shown in FIGS. 5C and 5D, each of the balloon cover crimp shell portions 460a and / or 460b can include respective proximal balloon engagement surfaces 462a or 462b that engage the inflatable balloon 230 when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230. In particular, engagement between the proximal balloon engagement surface 462 and the inflatable balloon 230 can facilitate establishing and / or preserving the formed geometric shape of the inflatable balloon 230. Additionally, or alternatively, engagement between the proximal balloon engagement surfaces 462a and 462b and the inflatable balloon 230 can limit the axial translation of the balloon cover crimp shell portion 460 relative to the inflatable balloon 230 when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230.

[0113] Each of the proximal balloon engagement surfaces 462a and 462b can include and / or can be any of a variety of structural mechanisms for engaging the inflatable balloon 230. For example, at least as shown in FIGS. 5C and 5D, each of the proximal balloon engagement surfaces 462a and / or 462b can include and / or can 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 illustrated embodiment, 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 crimp shell portions 460a and 460b are assembled together, the locking ribs 464a and 464b are alternately arranged with respect to each other.

[0114] In some embodiments, the proximal balloon engagement surfaces 462a and 462b may 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, if each of the proximal balloon engagement surfaces 462a and 462b includes respective locking ribs 464a and 464b, the locking ribs 464a may be arranged alternately with the locking ribs 464b and configured to frictionally engage, and thus limit the balloon cover clam shell portions 460a and 460b from being removed from each other. Stated another way, in such embodiments, the proximal balloon engagement surfaces 462a and 462b are configured to engage with each other to mechanically hold the balloon cover clam shell portions 460a and 460b together when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230.

[0115] As described above, the balloon cover clam shell portions 460a / 460b and / or their proximal balloon engagement surfaces 462a / 462b may engage the inflatable balloon 230 to facilitate establishing and / or preserving the geometry of the inflatable balloon 230. In particular, the engagement between the proximal balloon engagement surfaces 462a / 462b and the inflatable balloon 230 may be manipulated to slightly compress and / or mechanically shape the inflatable balloon 230 (such as the proximal portion 232 of the inflatable balloon 230 as shown in FIGS. 3 and 4).

[0116] Additionally or alternatively, such engagement may be manipulated to form the inflatable balloon 230 into a reduced radius outer profile (e.g., relative to the outer profile before the balloon cover assembly 450 is operably coupled to the inflatable balloon 230) that can be sustained when the inflatable balloon 230 is removed from the balloon cover clam shell portions 460a / 460b. Such a constricted outer profile may facilitate ensuring that the final outer profile of the inflatable balloon 230 (e.g., after using the compressor assembly 100 disclosed herein) is small enough to extend within the inner diameter of the guide catheter shaft 214.

[0117] In some embodiments, a pair of balloon cover crimp shell portions 460a and 460b are at least substantially similar and / or identical to each other. For example, in the embodiments of FIGS. 5A-5D, the balloon cover crimp shell portions 460a and 460b are identical to each other except for the configuration of their respective proximal balloon engagement surfaces 462a / 462b and the number of locking ribs 464. Specifically, the balloon cover crimp shell portion 460a (FIG. 5C) includes a proximal balloon engagement surface 462a having four locking ribs 464, while the balloon cover crimp shell portion 460b (FIG. 5D) includes a proximal balloon engagement surface 462b having three locking ribs 464.

[0118] While the present disclosure generally relates to embodiments in which the balloon cover assembly 450 comprises a pair of balloon cover crimp shell portions 460 (e.g., balloon cover crimp shell portions 460a and 460b), this is not essential to all embodiments of the balloon cover assembly 450. For example, it is within the scope of the present disclosure that the balloon cover assembly 450 may comprise any suitable number of balloon cover crimp shell portions 460 for engaging the inflatable balloon 230 described herein, such as three balloon cover crimp shell portions 460, four balloon cover crimp shell portions 460, or five or more balloon cover crimp shell portions 460.

[0119] In some embodiments, at least as shown in FIGS. 2 and 5A, a pair of balloon cover crimp shell portions 460 are configured to engage each other when the balloon cover assembly is operably coupled to the inflatable balloon 230. More specifically, the pair of balloon cover crimp shell portions 460 may be configured to abut and / or fit together with each other.

[0120] However, this is not necessary for all embodiments of the balloon cover assembly 450, and additionally, it is within the scope of the present disclosure that the balloon cover crimp shell portions 460 can be spaced apart from each other when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230.

[0121] In some embodiments, the balloon cover assembly 450 can be configured to engage the compression alignment tool 400, additionally or alternatively, 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 compression alignment tool 400 such that when the balloon cover assembly 450 is operably coupled to the inflatable balloon 230 and the compression alignment tool 400 is in an aligned configuration, the balloon cover assembly 450 restricts the compression alignment tool 400 from being removed from the valve delivery device 200.

[0122] As a more specific example, at least as shown in FIG. 3, the compression alignment tool 400 can include a crimp shell engagement mechanism 430, and each balloon cover crimp shell portion 460 can include a compression alignment tool engagement mechanism 470 that engages the crimp shell engagement mechanism 430 when the balloon cover assembly 450 operably engages the compression alignment tool 400.

[0123] The crimp shell engagement mechanism 430 and the compression alignment tool engagement mechanism 470 can include any suitable mechanism, such as a mechanism that fits and / or mechanically engages with each other, to limit and / or prevent the axial translation of the compression alignment tool 400 relative to the balloon cover assembly 450, and / or can be any suitable mechanism. As a more specific example, as shown in FIG. 3, the crimp shell engagement mechanism 430 can include an annular groove 432, and each compression alignment tool engagement mechanism 470 can include an engagement tooth 472. In particular, FIG. 3 labels the engagement tooth 472b of the second balloon cover crimp shell portion 460b, and the engagement tooth 472a of the first balloon cover crimp shell portion 460a is shown more clearly in FIG. 4.

[0124] As shown in FIG. 4, each engaging tooth 472a and 472b may extend radially inwardly such that when the balloon cover assembly 450 is operably engaged with the compression alignment tool 400, each engaging tooth extends into the annular groove 432. Thus, in such an embodiment, when the balloon cover assembly 450 is operably engaged with the compression alignment tool 400, each engaging tooth 472 is received within a portion of the annular groove 432 to limit the axial translation of the compression alignment tool 400 relative to the balloon cover assembly 450.

[0125] In this way, in the illustrated embodiment, each compression alignment tool engagement mechanism 470 may be described as a male fitting mechanism and the clam shell engagement mechanism 430 may be described as a female fitting mechanism. However, this is not necessary for all embodiments of the balloon cover assembly and / or the compression alignment tool. For example, additionally or alternatively, it is within the scope of the present disclosure that each compression alignment tool engagement mechanism 470 may also include a female fitting mechanism (e.g., groove, channel, trough, recess, indentation, etc.) and / or may be a female fitting mechanism. Similarly, additionally or alternatively, it is within the scope of the present disclosure that the clam shell engagement mechanism 430 may also include a male fitting mechanism (e.g., tooth, protrusion, ridge, etc.) and / or may be a male fitting mechanism.

[0126] Exemplary Method Referring now to FIG. 19, the present disclosure provides a method of attaching a transplantable artificial valve to a valve delivery device for delivering the transplantable artificial valve to a target implantation site within a patient's vasculature. The method may be practiced in conjunction with any suitable components of the artificial valve preparation assembly 10 disclosed herein. Thus, in the present disclosure, any description of components, mechanisms, features, configurations, etc. presented with reference to the steps of the method is to be understood as referring to any corresponding (e.g., similarly named) components, mechanisms, features, configurations, etc. disclosed herein with reference to the artificial valve preparation assembly 10 and / or with reference to FIGS. 1 - 18.

[0127] As shown in FIG. 19, method 500 may include, at 510, inserting the balloon catheter of the valve delivery device into the central passage of the frame of the implantable prosthetic valve. For example, inserting the balloon catheter into the central passage at 510 may include sliding the implantable prosthetic valve axially on the distal portion of the valve delivery device to position the implantable prosthetic valve around and / or proximate to the inflatable balloon.

[0128] FIG. 12 may be described as showing an example configuration of an implantable prosthetic valve and a valve delivery device after performing the insertion of the balloon catheter into the central passage at 510.

[0129] In some embodiments, as described above, the valve delivery device may include a balloon cover assembly having a pair of balloon cover clam shell portions and a balloon cover sleeve. In some such embodiments, method 500 may be initiated and / or at least partially implemented while the balloon cover assembly is operably coupled to the inflatable balloon. Thus, in some embodiments, method 500 further includes removing the balloon cover assembly from the inflatable balloon before inserting the balloon catheter into the central passage at 510.

[0130] In some such embodiments, removing the balloon cover assembly includes removing the balloon cover sleeve from the pair of balloon cover clam shell portions (e.g., by sliding the balloon cover sleeve axially away from the balloon cover clam shell portions). After removing the balloon cover assembly, the method may include removing the pair of balloon cover clam shell portions from the inflatable balloon.

[0131] At 520, method 500 may include partially compressing the annular frame of the implantable artificial valve with a compressor assembly. As discussed herein, the compressor assembly may be utilized to partially compress the annular frame of the implantable artificial valve to place the implantable artificial valve in an intermediate configuration, and the implantable artificial valve may be selectively but intentionally positioned along the valve delivery device.

[0132] As discussed herein, partially compressing the annular frame at 520 may include radially compressing the implantable artificial valve to a diameter that is at least substantially equal to the first stop diameter, such as may be defined by the diameter of the compressor opening.

[0133] In some embodiments, partially compressing the annular frame at 520 includes engaging the implantable artificial valve directly with the jaws of the compressor assembly.

[0134] As disclosed herein, the compressor assembly may include a first compression stop and a second compression stop that individually or collectively define the range of motion of the actuator handle of the compressor assembly. In particular, partially compressing the annular frame at 520 may include actuating the actuator handle while the second compression stop is fixedly coupled to the housing of the compressor assembly and while the first compression stop is operably coupled to the second compression stop. Thus, in some embodiments, method 500 further includes operably coupling the first compression stop to the second compression stop, such as by inserting the second compression stop into a second compression stop receiver of the first compression stop, prior to partially compressing the annular frame at 520.

[0135] With the first compression stop operably coupled to the second compression stop, partially compressing the annular frame at 520 may include positioning the implantable artificial valve within the compressor opening of the compressor assembly (e.g., as shown in FIG. 13) and actuating the actuator handle to engage the first compression stop (e.g., as shown in FIG. 14).

[0136] In particular, in some embodiments, the implantable artificial valve is positioned within the compressor opening such that the overall length of the implantable artificial valve is contained within the compressor opening length of the compressor opening. As a result, partially compressing the annular frame 520 can include radially uniformly compressing the annular frame over its entire length.

[0137] At 530, method 500 can include operably coupling a compression alignment tool to a distal portion of the valve delivery device to position the compression alignment tool in an alignment configuration with respect to the valve delivery device. In particular, as described in more detail herein, when the compression alignment tool is in the alignment configuration, the compression alignment tool can be utilized to determine and / or establish a target compression position of the implantable artificial valve on the inflatable balloon.

[0138] In some embodiments, operably coupling the compression alignment tool at 530 includes engaging a distal portion of the valve delivery device with the compression alignment tool to position the compression alignment tool in the alignment configuration. This can be accomplished in any suitable manner, such as by receiving the distal portion of the valve delivery device within the compression alignment tool such that the stylet of the valve delivery device extends partially within the distal opening of the compression alignment tool.

[0139] In various embodiments, operably coupling the compression alignment tool at 530 to the valve delivery device can be performed before or after partially compressing the annular frame at 520. FIG. 15 can be described as showing an embodiment of the configuration of the implantable artificial valve and the valve delivery device after partially compressing the annular frame at 520 and after operably coupling the compression alignment tool at 530.

[0140] In some embodiments, operably coupling the compression alignment tool 530 additionally or alternatively may include axially advancing the compression alignment tool toward the expandable balloon until further axial advancement of the compression alignment tool is restricted (e.g., due to the stylet engaging the distal end of the compression alignment tool).

[0141] In some embodiments, operably coupling the compression alignment tool 530 includes visually verifying that the compression alignment tool has reached an alignment configuration. For example, as described above, the compression alignment tool may include a distal alignment indicator configured to provide a visual indication that the compression alignment tool is in an alignment configuration. Thus, in some embodiments, method 500 may include visually verifying the axial position of the valve delivery device relative to the distal alignment indicator.

[0142] As a more specific example, in some embodiments, visually verifying the axial position of the valve delivery device includes, for example, visually verifying that components of the valve delivery device (such as the proximal edge of the stylet) are axially aligned with the proximal or distal edge of a window defined in the compression alignment tool, as shown in FIG. 15.

[0143] Additionally or alternatively, verifying the axial position of the valve delivery device may include verifying that components of the valve delivery device are axially aligned with one or more visual markings of the compression alignment tool, as described above.

[0144] At 540, method 500 may include positioning a transplantable prosthetic valve for engagement with the compression alignment tool. For example, positioning a transplantable valve for engagement with the compression alignment tool at 540 may include axially translating the transplantable prosthetic valve relative to the valve delivery device such that the distal frame end of the annular frame engages the valve stop of the compression alignment tool.

[0145] In some embodiments, positioning the implantable prosthetic valve to engage the compression alignment tool 540 is performed after partially compressing the annular frame 520 at 520. In particular, while in the intermediate configuration, if the implantable prosthetic valve is positioned to engage the compression alignment tool, the implantable prosthetic valve can remain in a substantially fixed axial position relative to the inflatable balloon while the implantable prosthetic valve is fully compressed onto the inflatable balloon.

[0146] In other words, in such embodiments, positioning the implantable prosthetic valve to engage the compression alignment tool 540 is performed by the implantable prosthetic valve in the intermediate configuration, and the implantable prosthetic valve is substantially fixed in a predetermined position relative to the inflatable balloon until intentionally repositioned. In this way, partially compressing the annular frame to transition the implantable prosthetic valve to the intermediate configuration facilitates positioning the implantable prosthetic valve to engage the compression alignment tool, as discussed below, such that the implantable prosthetic valve remains in a predetermined position relative to the compression alignment tool during subsequent compression steps.

[0147] FIG. 15 may be further described as showing an embodiment of the configuration of the implantable prosthetic valve and the valve delivery device after partially compressing the annular frame at 520, operably coupling the compression alignment tool at 530, and positioning the implantable prosthetic valve at 540.

[0148] At 550, method 500 may include fully compressing the annular frame of the implantable prosthetic valve. As discussed herein, a compression assembly may be utilized to fully compress the annular frame of the implantable prosthetic valve to place the implantable prosthetic valve in a delivery configuration. When the implantable prosthetic valve is in the delivery configuration, the annular frame of the implantable prosthetic valve is contracted to a diameter that is at least substantially equal to a second stop diameter that is smaller than the first stop diameter. In some embodiments, fully compressing the annular frame at 550 includes directly engaging the implantable prosthetic valve with the jaws of the compression assembly.

[0149] As discussed herein, fully compressing the annular frame at 550 can include actuating the actuator handle while the second compression stop is fixedly coupled to the housing of the compressor assembly, but while the first compression stop is removed from the second compression stop. Thus, in some embodiments, method 500 further includes removing the first compression stop from the second compression stop before fully compressing the annular frame at 550.

[0150] In some embodiments, removing the first compression stop from the second compression stop can include gripping the gripping mechanism of the initial compression upper portion to pivot the first compression stop relative to the second compression stop and / or pull the first compression stop away from the second compression stop.

[0151] With the first compression stop removed from the second compression stop, fully compressing the annular frame at 550, as shown in FIG. 16, can include positioning the implantable prosthetic valve within the compressor opening of the compressor assembly and actuating the actuator handle to engage the second compression stop.

[0152] In particular, in some embodiments, the implantable prosthetic valve is positioned within the compressor opening such that the overall length of the implantable prosthetic valve is contained within the compressor opening length of the compressor opening. As a result, fully compressing the annular frame at 550 can include radially and evenly compressing the annular frame over the entire length of the annular frame.

[0153] In some embodiments, actuating the actuator handle to once engage the second compression stop may be insufficient to maintain the implantable prosthetic valve in the delivery configuration after the jaws of the compressor assembly are released from the implantable prosthetic valve. For example, the annular frame of the implantable prosthetic valve may be sufficiently stiff and / or elastic such that, after compressing the annular frame to the second stop diameter by compressing the annular frame at 550, the annular frame expands slightly to a diameter greater than the second stop diameter after the jaws are released.

[0154] Accordingly, in some embodiments, method 500 further includes actuating the actuator handle to release the jaws of the compressor assembly from the implantable prosthetic valve after actuating the actuator handle to engage the second compression stop, and repeating actuating the actuator handle to engage the second compression stop. Stated another way, in such embodiments, fully compressing the annular frame at 550 includes repeatedly compressing the implantable prosthetic valve by the compressor assembly to ensure that the annular frame remains at a diameter substantially equal to the second stop diameter after the jaws are released from the annular frame. In such embodiments, fully compressing the annular frame at 550 may include contacting the actuator handle with the second compression stop any suitable number of times, including at least twice, at least three times, at least four times, and / or up to five times.

[0155] When the implantable prosthetic valve is fully compressed on the inflatable balloon and in the delivery configuration, the valve delivery device may be prepared for insertion into the patient's vasculature, except that the various components associated with method 500 may remain coupled to the valve delivery device.

[0156] Accordingly, in some embodiments, method 500 further includes removing a compression alignment tool from the valve delivery device and / or removing a stylet of the valve delivery device from the nose piece. For example, FIG. 17 may be described as showing the configuration of a transplantable prosthetic valve and a valve delivery device with the stylet still coupled to the nose piece after the annular frame has been fully compressed at 550, while FIG. 18 may be described as showing these components after the stylet has been removed from the nose piece. Further, FIG. 18 shows a configuration in which the guide catheter is advanced distally relative to the configuration of FIG. 17 such that the guide catheter extends proximate to the fully compressed transplantable prosthetic valve.

[0157] In particular, referring to the embodiments of FIGS. 17 and 18, when the transplantable prosthetic valve 300 is fully compressed onto the inflatable balloon 230, the proximal portion 232 of the inflatable balloon 230 may not be covered (as shown in FIG. 17). To prepare the valve delivery device 200 for advancement through the patient's vasculature, the proximal portion 232 of the inflatable balloon 230 may be covered by advancing the guide catheter shaft 214 distally for abutting and / or engaging the transplantable prosthetic valve 300 (as shown in FIG. 18).

[0158] As described above, the various components and / or mechanisms of the prosthetic valve preparation assembly 10 may be configured to facilitate advancing the guide catheter shaft 214 over the proximal portion 232 of the inflatable balloon 230. For example, as described above, engagement between the proximal balloon engagement surfaces 462a / 462b and the inflatable balloon 230 operably compresses and / or mechanically forms the proximal portion 232 of the inflatable balloon 230 into a profile that is preferably contracted such that the proximal portion 232 can extend within the inner diameter of the guide catheter shaft 214.

[0159] Any system, device, instrument, etc. in this specification can be sterilized (e.g., using heating / heat, pressure, steam, radiation, and / or chemicals, etc.) to ensure safe use for patients, and any method in this specification can include sterilizing the associated system, device, instrument, etc. as one of the steps of the method. Examples of sterilization by heating / heat include sterilization by steam and sterilization by autoclave. Examples of radiation for use in sterilization include, but are not limited to, gamma rays, ultraviolet rays, and electron beams. Examples of chemicals for use in sterilization include, but are not limited to, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization by hydrogen peroxide can be carried out, for example, using hydrogen peroxide plasma.

Examples

[0160] Additional examples of the disclosed technology In view of the implementations described above with respect to the disclosed subject matter, this application discloses the additional examples listed below. It should be noted that one individual feature in an example, or two or more features in combination in that example, and optionally in combination with one or more features in one or more further examples, are also further examples that fall within the disclosure of this application.

[0161] Example 1. A transplantable artificial valve comprising an annular frame defining a frame central passage and a valve assembly positioned within the frame central passage, a valve delivery device configured to deliver the transplantable artificial valve through a patient's vasculature to a target implantation site, and a compression assembly for compressing the transplantable artificial valve around the valve delivery device, the compression assembly comprising an actuator handle configured to be manually actuated to compress the transplantable artificial valve around the valve delivery device, a second compression stop defining the full range of motion of the actuator handle, a first compression stop defining a partial range of motion of the actuator handle and configured to be selectively and operably coupled to the second compression stop, and a compression alignment tool configured to facilitate compressing the transplantable artificial valve against an inflatable balloon of the valve delivery device, the compression alignment tool being configured to engage the transplantable artificial valve to position the transplantable artificial valve at a target compression position relative to the valve delivery device, and the compression alignment tool being configured to be slid axially on a distal portion of the valve delivery device to operably couple the compression alignment tool to the valve delivery device, the artificial valve preparation assembly.

[0162] Example 2. 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 on the balloon catheter, a nose piece mounted at a distal end of the valve delivery device to facilitate advancement of the valve delivery device through a patient's vasculature to a target implantation site, and a stylet configured to be removably coupled to a distal end of the nose piece, the valve delivery device being configured such that the transplantable artificial valve is directly mounted on the inflatable balloon prior to introducing the valve delivery device into a patient's vasculature, the artificial valve preparation system according to any one of the examples herein, particularly Example 1.

[0163] Example 3. The nose piece has a nose piece lumen, and the stylet comprises a stylet shaft configured to be received within the nose piece lumen for selectively coupling the stylet to the nose piece, of any of the embodiments herein, particularly the artificial valve preparation system described in embodiment 2.

[0164] Example 4. The artificial valve preparation system further comprises a balloon cover assembly configured to be operably coupled to an inflatable balloon, the balloon cover assembly comprising a pair of balloon cover clam shell portions configured to be mounted on opposite sides of the inflatable balloon when the balloon cover assembly is operably coupled to the inflatable balloon, and a balloon cover sleeve configured to surround the pair of balloon cover clam shell portions for holding the balloon cover clam shell portions against the inflatable balloon when the balloon cover assembly is operably coupled to the inflatable balloon, wherein when the balloon cover assembly is operably coupled to the inflatable balloon, the balloon cover sleeve restricts removal of the balloon cover clam shell portions from the inflatable balloon, and the balloon cover sleeve is configured to slide axially outward from the pair of balloon cover clam shell portions to enable removal of the pair of balloon cover clam shell portions from the inflatable balloon, of any of the embodiments herein, particularly any one of embodiments 2 - 3.

[0165] Example 5. The balloon cover assembly is configured to engage a compression alignment tool such that when the balloon cover assembly is operably coupled to the inflatable balloon by the compression alignment tool operably coupled to the distal portion of the valve delivery device, the balloon cover assembly restricts removal of the compression alignment tool from the distal portion of the valve delivery device, of any of the embodiments herein, particularly the artificial valve preparation system described in embodiment 4.

[0166] Example 6. Each balloon cover column shell portion comprises a proximal balloon engagement surface configured to engage an inflatable balloon when the balloon cover assembly is operably coupled to the inflatable balloon, in any of the embodiments described herein, particularly any one of embodiments 4-5, of the artificial valve preparation system.

[0167] Embodiment 7. The proximal balloon engagement surface is configured to engage an inflatable balloon to mechanically shape at least a portion of the inflatable balloon, in any of the embodiments described herein, particularly any one of embodiments 4-6, of the artificial valve preparation system.

[0168] Embodiment 8. The compressor assembly further comprises a base, a housing fixedly attached to the base and defining a central axis of the compressor assembly, and a plurality of circumferentially arranged nested jaws supported within the housing, the jaws being movable radially within the housing toward and away from the central axis, the plurality of jaws collectively defining a compressor opening whose diameter changes as the jaws move toward and away from the central axis, an actuator handle being movable relative to the housing to move the jaws toward and away from the central axis, and a second compression stop being fixedly coupled to the housing during use of the compressor assembly, in any of the embodiments described herein, particularly any one of embodiments 1-7, of the artificial valve preparation system.

[0169] Embodiment 9. The compressor opening extends along a compressor opening length that is greater than or equal to the valve length of the implantable artificial valve as measured along a direction parallel to the central axis of the compressor assembly, in any of the embodiments described herein, particularly the artificial valve preparation system described in Embodiment 8.

[0170] Embodiment 10. The first compression stop portion includes a receiver channel for receiving the elongated portion of the second compression stop portion when the first compression stop portion is mechanically coupled to the second compression stop portion, according to any embodiment of the present specification, particularly any one of embodiments 1 to 9 of the artificial valve preparation system described herein.

[0171] Example 11. The first compression stop portion includes a gripping mechanism configured to facilitate removal of the first compression stop portion from the second compression stop portion, and the gripping mechanism includes one or more of a tab, a lever, a protrusion, and a recess, according to any embodiment of the present specification, particularly any one of embodiments 1 to 10 of the artificial valve preparation system described herein.

[0172] Example 12. The compression alignment tool includes a catheter receiver configured to receive the distal portion of the valve delivery device to position the compression alignment tool in an aligned configuration relative to the valve delivery device, a distal end of the compression alignment tool configured to engage the distal portion of the valve delivery device to hold the compression alignment tool in the aligned configuration, and a valve stop portion positioned in the proximal region of the compression alignment tool and configured to engage the distal frame end of the annular frame of the implantable artificial valve. The compression alignment tool is configured to be operated to position the implantable artificial valve at the target compression position by positioning the implantable artificial valve such that the distal frame end engages the valve stop portion when the distal end of the compression alignment tool engages the distal portion of the valve delivery device and the compression alignment tool is in the aligned configuration, according to any embodiment of the present specification, particularly any one of embodiments 1 to 11 of the artificial valve preparation system described herein.

[0173] Example 13. The valve delivery device includes a nose piece and a stylet configured to be removably coupled to the distal end of the nose piece. The compression alignment tool is configured such that the stylet engages the distal end of the compression alignment tool when the compression alignment tool is in the aligned configuration, according to any embodiment of the present specification, particularly the artificial valve preparation system described in Example 12.

[0174] Example 14. The nose piece has a nose piece lumen, the stylet has a stylet shaft configured to be received within the nose piece lumen for selectively coupling the stylet to the nose piece, the valve delivery device has an operable guide catheter and a balloon catheter extending through the guide catheter, the stylet shaft extends within the nose piece lumen and is configured to engage the distal end of the balloon catheter, such that a compression alignment tool, when in an alignment configuration with the distal end of the compression alignment tool engaged with the distal portion of the valve delivery device, has the axial position of the valve stop portion coincide with at least a portion of the target compression position, an artificial valve preparation system according to any of the embodiments herein, particularly Example 13.

[0175] Example 15. A compression alignment tool comprising a catheter receiver configured to receive the distal portion of a valve delivery device for positioning the compression alignment tool in an alignment configuration with respect to the valve delivery device, a distal end of the compression alignment tool configured to engage the distal portion of the valve delivery device for holding the compression alignment tool in the alignment configuration, and a valve stop positioned within the proximal region of the compression alignment tool and configured to engage the distal frame end of an annular frame of a transplantable artificial valve, wherein the compression alignment tool is configured to be operated to position the transplantable artificial valve at a target compression position by positioning the transplantable artificial valve such that the distal frame end engages the valve stop when the compression alignment tool is in the alignment configuration with the distal end of the compression alignment tool engaged with the distal portion of the valve delivery device.

[0176] Example 16. The compression alignment tool according to any of the embodiments herein, particularly Example 15, wherein the compression alignment tool is configured to be slid axially on the distal portion of the valve delivery device for operably coupling the compression alignment tool to the valve delivery device.

[0177] Example 17. The compression alignment tool is configured such that, when the compression alignment tool is in an aligned configuration, removal of the compression alignment tool from the valve delivery device is at least partially restricted, the compression alignment tool according to any one of the embodiments described herein, particularly any one of embodiments 15-16.

[0178] Example 18. The compression alignment tool further comprises a distal alignment indicator configured to provide a visual indication that the compression alignment tool is in an aligned configuration with respect to the valve delivery device, the distal alignment indicator comprising a window that enables visual inspection of the valve delivery device by the compression alignment tool, the compression alignment tool being configured such that, when the compression alignment tool is in an aligned configuration with respect to the valve delivery device, components of the valve delivery device are axially aligned with one or both of a distal edge and a proximal edge of the window, the compression alignment tool according to any one of the embodiments described herein, particularly any one of embodiments 15-17.

[0179] Example 19. A method of attaching a transplantable artificial 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 transplantable artificial valve, partially compressing an annular frame of the transplantable artificial valve with a compression assembly, and fully compressing the annular frame of the transplantable artificial valve.

[0180] Example 20. After partially compressing the annular frame of the transplantable artificial valve and before fully compressing the annular frame of the transplantable artificial valve, operably coupling a compression alignment tool to a distal portion of the valve delivery device to position the compression alignment tool in an aligned configuration with respect to the valve delivery device, and positioning the transplantable artificial valve to engage the compression alignment tool, the method according to any one of the embodiments described herein, particularly the method described in Example 19.

[0181] Example 21. The valve delivery device comprises a nose piece mounted at the distal end of the valve delivery device and a stylet configured to be removably coupled to the distal end of the nose piece. The compression alignment tool comprises a window that enables visual inspection of the valve delivery device by the compression alignment tool. The method further comprises visually verifying that the stylet is axially aligned with one of the distal edge or the proximal edge of the window. Any of the embodiments described herein, particularly the method described in Embodiment 20.

[0182] Example 22. The valve delivery device comprises a nose piece mounted at the distal end of the valve delivery device and a stylet configured to be removably coupled to the distal end of the nose piece. The compression alignment tool comprises a distal end of the compression alignment tool having a distal opening. Operably coupling the compression alignment tool to the distal portion of the valve delivery device includes engaging the stylet with the distal end of the compression alignment tool. Engaging the stylet includes at least partially inserting the stylet through the distal opening. Any of the embodiments described herein, particularly the method described in any one of Embodiments 20 - 21.

[0183] Example 23. Positioning a transplantable artificial valve for engagement with the compression alignment tool includes axially translating the transplantable artificial valve relative to the valve delivery device such that the distal frame end of the annular frame engages the valve stop portion of the compression alignment tool. Any of the embodiments described herein, particularly the method described in any one of Embodiments 20 - 22.

[0184] Example 24. The compressor assembly is configured to be manually actuated and includes an actuator handle for compressing a transplantable artificial valve around a valve delivery device, a second compression stop defining the full range of motion of the actuator handle, and a first compression stop defining a partial range of motion of the actuator handle and configured to be selectively and operably coupled to the second compression stop. Partially compressing the annular frame includes actuating the actuator handle to engage the first compression stop with the first compression stop operably coupled to the second compression stop. Completely compressing the annular frame includes actuating the actuator handle to engage the second compression stop. The method further includes removing the first compression stop from the second compression stop after partially compressing the annular frame and before completely compressing the annular frame. The method according to any one of the embodiments herein, particularly any one of embodiments 19 to 23.

[0185] Example 25. A compressor assembly for compressing a transplantable artificial valve around a valve delivery device, the compressor assembly comprising an actuator handle configured to be manually actuated, a second compression stop defining the full range of motion of the actuator handle, and a first compression stop defining a partial range of motion of the actuator handle and configured to be selectively and operably coupled to the second compression stop.

[0186] Example 26. The compressor assembly further comprises a base, a housing fixedly attached to the base and defining a central axis of the compressor assembly, and a plurality of nested jaws arranged circumferentially and supported within the housing. The jaws are movable radially within the housing toward and away from the central axis, and the plurality of jaws collectively define a compressor aperture whose diameter changes as the jaws move toward and away from the central axis. The compressor assembly according to any one of the embodiments herein, particularly the compressor assembly described in Example 25.

[0187] Example 27. The actuator handle is movable relative to the housing to move away from the central axis toward the jaw portion, for any embodiment of this specification, particularly the compressor assembly of embodiment 26.

[0188] Example 28. The second compression stop is fixedly coupled to the housing during use of the compressor assembly, for any embodiment of this specification, particularly the compressor assembly described in any one of embodiments 25 - 27.

[0189] Example 29. When the first compression stop is operably coupled to the second compression stop, the actuator handle is actuated to engage the first compression stop so that the compressor opening is sized to a first stop diameter, and when the first compression stop is removed from the second compression stop, the actuator handle is actuated to engage the second compression stop so that the compressor opening is sized to a second stop diameter smaller than the first stop diameter, for any embodiment of this specification, particularly the compressor assembly described in any one of embodiments 25 - 28.

[0190] Example 30. The compressor opening extends along a compressor opening length that is greater than or equal to the valve length of a transplantable artificial valve, measured in a direction parallel to the central axis of the compressor assembly, for any embodiment of this specification, particularly the compressor assembly described in any one of embodiments 25 - 29.

[0191] Example 31. The first compression stop includes a body of the first compression stop that defines a terminus of the first compression stop and terminates at the terminus of the first compression stop, and the compressor assembly is configured such that the actuator handle engages the terminus of the first compression stop during use of the compressor assembly and when the first compression stop is operably coupled to the second compression stop, for any embodiment of this specification, particularly the compressor assembly described in any one of embodiments 25 - 30.

[0192] Example 32. The second compression stop portion defines the end of the second compression stop portion and includes a body of the second compression stop portion that terminates at the end of the second compression stop portion. The compressor assembly is configured to engage the end of the second compression stop portion when the actuator handle is in use in the compressor assembly and when the first compression stop portion is removed from the second compression stop portion. The compressor assembly is as described in any one of the embodiments herein, particularly any one of Embodiments 25 to 31.

[0193] Embodiment 33. The first compression stop portion includes a second compression stop receiver configured to receive, optionally, the end of the second compression stop portion of the body of the second compression stop portion when the first compression stop portion is operably coupled to the second compression stop portion. The compressor assembly is as described in any one of the embodiments herein, particularly any one of Embodiments 25 to 32.

[0194] Embodiment 34. The second compression stop receiver includes a receiver channel configured to receive the elongated portion of the second compression stop portion when the first compression stop portion is operably coupled to the second compression stop portion. The compressor assembly is as described in any one of the embodiments herein, particularly Embodiment 33.

[0195] Embodiment 35. The first compression stop portion includes a gripping mechanism configured to facilitate removal of the first compression stop portion from the second compression stop portion. The compressor assembly is as described in any one of the embodiments herein, particularly any one of Embodiments 25 to 34.

[0196] Embodiment 36. The gripping mechanism is configured to be gripped by a user to enable the user to apply torque to the first compression stop portion to remove the first compression stop portion from the second compression stop portion. The compressor assembly is as described in any one of the embodiments herein, particularly Embodiment 35.

[0197] Embodiment 37. The gripping mechanism is a compressor assembly product according to any one of the embodiments herein, particularly any one of Embodiments 35 to 36, configured to be gripped by a user to enable the user to pull the first compression stop portion away from the second compression stop portion.

[0198] Embodiment 38. The gripping mechanism is a compressor assembly product according to any one of the embodiments herein, particularly any one of Embodiments 35 to 37, comprising one or more of a tab, a lever, a protrusion, and a recess.

[0199] Embodiment 39. During use of the compressor assembly product, the second compression stop portion is a compressor assembly product according to any one of the embodiments herein, particularly any one of Embodiments 25 to 38, coupled to one or both of the base and the housing at the compression stop portion attachment location.

[0200] Embodiment 40. The second compression stop portion is a compressor assembly product according to any one of the embodiments herein, particularly Embodiment 39, not configured to be removed from the compression stop portion attachment location without damaging the compressor assembly product.

[0201] Embodiment 41. The second compression stop portion is a compressor assembly product according to any one of the embodiments herein, particularly Embodiment 39, configured to be selectively and repeatedly coupled to and removed from the compression stop portion attachment location without damaging the compressor assembly product.

[0202] Embodiment 42. A compressor assembly further comprising a base, a housing fixedly attached to the base and defining a central axis of the compressor assembly, and a plurality of nested jaws arranged circumferentially and supported within the housing, wherein the jaws are movable radially within the housing toward and away from the central axis, and the plurality of jaws collectively define a compressor opening whose diameter changes as the jaws move toward and away from the central axis, and one or both of the base and the housing comprises a compression stop receiver defining a compression stop attachment location, the compressor assembly according to any one of the embodiments described herein, particularly any one of embodiments 39-41.

[0203] Example 43. A second compression stop is configured to be operably coupled to the compression stop receiver via one or more of a friction fit, snap fit, latch, and key coupling, the compressor assembly according to any one of the embodiments described herein, particularly embodiment 42.

[0204] Example 44. A valve delivery device comprising an operable guide catheter having a handle portion and a guide catheter shaft extending from the handle portion, a balloon catheter extending through the guide catheter, an inflatable balloon attached to the balloon catheter, a nose piece attached to the distal end of the valve delivery device to facilitate advancement of the valve delivery device through a patient's vascular structure to a target implantation site, and a stylet configured to be removably coupled to the distal end of the nose piece, wherein the valve delivery device is configured such that a transplantable artificial valve is directly attached to the inflatable balloon prior to introducing the valve delivery device into a patient's vascular system.

[0205] Example 45. The balloon catheter comprises 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 through the handle portion and the guide catheter shaft, the valve delivery device according to any one of the embodiments described herein, particularly embodiment 44.

[0206] Example 46. The inflatable balloon is a valve delivery device according to any of the embodiments herein, particularly embodiment 45, attached to the distal portion.

[0207] Example 47. The guide catheter and the balloon catheter are configured to slide axially relative to each other to facilitate the delivery of a transplantable artificial valve and its positioning at the target implantation site, and are a valve delivery device according to any of the embodiments herein, particularly any one of embodiments 44 to 46.

[0208] Example 48. The balloon catheter shaft is an outer balloon catheter shaft, and the balloon catheter further includes an inner balloon catheter shaft extending coaxially from the proximal portion through the outer balloon catheter shaft and the inflatable balloon, and is a valve delivery device according to any of the embodiments herein, particularly any one of embodiments 44 to 47.

[0209] Example 49. The balloon catheter includes a fluid passage in fluid communication with an annular space defined between the inner balloon catheter shaft and the outer balloon catheter shaft and fluid-connectable to a fluid source for inflating the inflatable balloon, and is a valve delivery device according to any of the embodiments herein, particularly embodiment 48.

[0210] Example 50. The nose piece is configured to move independently of one or both of the guide catheter and the balloon catheter, and is a valve delivery device according to any of the embodiments herein, particularly any one of embodiments 44 to 49.

[0211] Example 51. The nose piece has a nose piece lumen, and the stylet comprises a stylet shaft configured to be received within the nose piece lumen for selectively coupling the stylet to the nose piece, a valve delivery device according to any one of the embodiments herein, particularly any one of embodiments 44 to 50.

[0212] Embodiment 52. The stylet shaft extends within the nose piece lumen and is configured to engage the distal end of the balloon catheter such that, as a result, when the compression alignment tool is in an aligned configuration with the distal end of the compression alignment tool engaged with the distal portion of the valve delivery device, the axial position of the valve stop portion of the compression alignment tool coincides with at least a portion of the target compression position of the implantable prosthetic valve, a valve delivery device according to any one of the embodiments herein, particularly embodiment 51.

[0213] Embodiment 53. The stylet is more rigid than the nose piece, a valve delivery device according to any one of the embodiments herein, particularly any one of embodiments 44 to 52.

[0214] Embodiment 54. The implantable prosthetic valve comprises an annular frame defining a frame central passage and a valve assembly positioned within the frame central passage, the annular frame being radially expandable and contractible to transition the implantable prosthetic valve between a delivery configuration in which the implantable prosthetic valve is sized for delivery through a patient's vasculature and an operative configuration in which the implantable prosthetic valve is sized to be operably mounted at a target implantation site, a valve delivery device according to any one of the embodiments herein, particularly any one of embodiments 44 to 53.

[0215] Embodiment 55. When the implantable prosthetic valve is mounted on an expandable balloon in the delivery configuration, the implantable prosthetic valve is restricted from translating relative to the expandable balloon, a valve delivery device according to any one of the embodiments herein, particularly embodiment 54.

[0216] Embodiment 56. The valve delivery device is configured to be operated such that, by expanding an inflatable balloon with a transplantable artificial valve attached thereto, the transplantable artificial valve is shifted from a delivery configuration to an operating configuration, as described in any of the embodiments herein, particularly any one of Embodiments 54 to 55 of the valve delivery device described herein.

[0217] Embodiment 57. The annular frame is further radially expandable and contractible to shift a transplantable artificial valve to an intermediate configuration defined between a delivery configuration and an operating configuration, and when the transplantable artificial valve is attached to the inflatable balloon in the intermediate configuration, the transplantable artificial valve engages the inflatable balloon such that the transplantable artificial valve is at least partially fixed in position relative to the inflatable balloon unless the transplantable artificial valve is intentionally repositioned by the user, as described in any of the embodiments herein, particularly any one of Embodiments 54 to 56 of the valve delivery device described herein.

[0218] Embodiment 58. A valve delivery device as described in any of the embodiments herein, particularly any one of Embodiments 44 to 57, in combination with a transplantable artificial valve.

[0219] Embodiment 59. A compression alignment tool configured to facilitate compressing a transplantable artificial valve against an inflatable balloon of a valve delivery device, the compression alignment tool being configured to engage the transplantable artificial valve to position the transplantable artificial valve at a target compression position relative to the valve delivery device.

[0220] Embodiment 60. The compression alignment tool includes a catheter receiver configured to receive the distal portion of the valve delivery device to position the compression alignment tool in an alignment configuration relative to the valve delivery device, a distal end of the compression alignment tool configured to engage the distal portion of the valve delivery device to hold the compression alignment tool in the alignment configuration, and a valve stop positioned within the proximal region of the compression alignment tool and configured to engage the distal frame end of the annular frame of the implantable artificial valve. The compression alignment tool is configured to be operated to position the implantable artificial valve at a target compression position by positioning the implantable artificial valve such that when the compression alignment tool is in the alignment configuration with the distal end of the compression alignment tool engaged with the distal portion of the valve delivery device, the distal frame end engages the valve stop. The compression alignment tool according to any embodiment described herein, particularly embodiment 59.

[0221] Example 61. The compression alignment tool is configured to be slid axially on the distal portion of the valve delivery device to operably couple the compression alignment tool to the valve delivery device. The compression alignment tool according to any embodiment described herein, particularly embodiment 60.

[0222] Example 62. The compression alignment tool is configured such that when the compression alignment tool is in an alignment configuration relative to the valve delivery device, removal of the compression alignment tool from the valve delivery device is at least partially restricted. The compression alignment tool according to any embodiment described herein, particularly any one of embodiments 59 - 61.

[0223] Example 63. The compression alignment tool is configured to engage the distal portion of the valve delivery device in one or more of a friction fit engagement, a mechanical engagement, a latch engagement, and a snap fit engagement. The compression alignment tool according to any embodiment described herein, particularly any one of embodiments 59 - 62.

[0224] Example 64. The compression alignment tool comprises a valve stop configured to be positioned within the proximal region of the compression alignment tool and engage the distal frame end of the annular frame of a transplantable artificial valve, and the compression alignment tool terminates at the proximal end of the compression alignment tool that defines the valve stop, the compression alignment tool according to any one of the embodiments described herein, particularly any one of embodiments 59 - 63.

[0225] Example 65. The compression alignment tool comprises a valve stop configured to be positioned within the proximal region of the compression alignment tool and engage the distal frame end of the annular frame of a transplantable artificial valve, and the compression alignment tool comprises a stepped inner surface that defines the valve stop, the compression alignment tool according to any one of the embodiments described herein, particularly any one of embodiments 59 - 63.

[0226] Example 66. The compression alignment tool is configured such that when the distal frame end engages the valve stop, the transplantable artificial valve is partially received within the compression alignment tool, the compression alignment tool according to any one of the embodiments described herein, particularly the compression alignment tool described in Example 65.

[0227] Example 67. The valve delivery device comprises a nose piece and a stylet configured to be removably coupled to the distal end of the nose piece, and the compression alignment tool is configured such that when the compression alignment tool is in an aligned configuration with respect to the valve delivery device, the stylet engages the distal end of the compression alignment tool, the compression alignment tool according to any one of the embodiments described herein, particularly any one of embodiments 59 - 66.

[0228] Example 68. The compression alignment tool is configured such that when the compression alignment tool is in an aligned configuration with respect to the valve delivery device, the inner diameter of the compression alignment tool mates with the outer diameter of the stylet, the compression alignment tool according to any one of the embodiments described herein, particularly the compression alignment tool described in Example 67.

[0229] Example 69. The distal end of the compression alignment tool, in any of the embodiments of this specification, particularly any one of embodiments 59 to 68, comprises a distal opening that receives the distal portion of the valve delivery device when the compression alignment tool is in an aligned configuration with the valve delivery device. The compression alignment tool is as described in any of the embodiments of this specification, particularly any one of embodiments 59 to 68, where the distal end of the compression alignment tool has a distal opening for receiving the distal part of the valve delivery device when the compression alignment tool is in an aligned configuration with the valve delivery device.

[0230] Example 70. The valve delivery device comprises a nose piece and a stylet configured to be removably coupled to the distal end of the nose piece. The compression alignment tool is configured such that when the compression alignment tool is in an aligned configuration, the stylet extends at least partially through the distal opening. The compression alignment tool is as described in any of the embodiments of this specification, particularly embodiment 69, where the valve delivery device includes a nose piece and a stylet configured to be removably attached to the distal end of the nose piece, and the compression alignment tool is configured so that when in an aligned configuration, the stylet extends at least partially through the distal opening.

[0231] Example 71. The compression alignment tool further comprises a distal alignment indicator configured to provide a visual indication that the compression alignment tool is in an aligned configuration with the valve delivery device. The compression alignment tool is as described in any of the embodiments of this specification, particularly any one of embodiments 59 to 70, where the compression alignment tool further has a distal alignment indicator configured to give a visual indication that the compression alignment tool is in an aligned configuration with the valve delivery device.

[0232] Example 72. The distal alignment indicator comprises a window that enables visual inspection of the valve delivery device by the compression alignment tool. The compression alignment tool is as described in any of the embodiments of this specification, particularly embodiment 71, where the distal alignment indicator has a window that allows visual inspection of the valve delivery device by the compression alignment tool.

[0233] Example 73. The compression alignment tool is configured such that when the compression alignment tool is in an aligned configuration with the valve delivery device, the components of the valve delivery device are axially aligned with one or both of the distal edge and the proximal edge of the window. The compression alignment tool is as described in any of the embodiments of this specification, particularly embodiment 72, where the compression alignment tool is configured so that when in an aligned configuration with the valve delivery device, the components of the valve delivery device are axially aligned with one or both of the distal and proximal edges of the window.

[0234] Example 74. The distal alignment indicator comprises one or more visual markings such that when the compression alignment tool is in an aligned configuration with the valve delivery device, the components of the valve delivery device are axially aligned with the visual markings. The compression alignment tool is as described in any of the embodiments of this specification, particularly any one of embodiments 71 to 73, where the distal alignment indicator has one or more visual markings so that when the compression alignment tool is in an aligned configuration with the valve delivery device, the components of the valve delivery device are axially aligned with the visual markings.

[0235] Example 75. The visual mark includes one or more of a mark, a colored mark, a printed mark, an embossed mark, a debossed mark, a line, and a symbol, and is the compression alignment tool according to any example herein, particularly Example 74.

[0236] Example 76. A balloon cover assembly, comprising: a pair of balloon cover clam shell portions configured to be mounted on opposite sides of an inflatable balloon when the balloon cover assembly is operably coupled to the inflatable balloon; and a balloon cover sleeve configured to surround the pair of balloon cover clam shell portions to hold the balloon cover clam shell portions against the inflatable balloon when the balloon cover assembly is operably coupled to the inflatable balloon. When the balloon cover assembly is operably coupled to the inflatable balloon, the balloon cover sleeve restricts the balloon cover clam shell portions from being removed from the inflatable balloon, and the balloon cover sleeve is configured to axially slide outward from the pair of balloon cover clam shell portions to enable the pair of balloon cover clam shell portions to be removed from the inflatable balloon.

[0237] Example 77. Each balloon cover clam shell portion includes a proximal balloon engaging surface configured to engage the inflatable balloon when the balloon cover assembly is operably coupled to the inflatable balloon, and is the balloon cover assembly according to any example herein, particularly Example 76.

[0238] Example 78. The proximal balloon engaging surface is configured to mechanically shape at least a portion of the inflatable balloon, and is the balloon cover assembly according to any example herein, particularly Example 77.

[0239] Example 79. The proximal balloon engagement surface is configured to engage an inflatable balloon to limit the axial translation of the balloon cover clam shell portion relative to the inflatable balloon when the balloon cover assembly is operably coupled to the inflatable balloon, as described in any of the embodiments herein, particularly any one of embodiments 77-78 of the balloon cover assembly.

[0240] Example 80. The proximal balloon engagement surface comprises one or more locking ribs extending radially toward the inflatable balloon when the balloon cover assembly is operably coupled to the inflatable balloon, as described in any of the embodiments herein, particularly any one of embodiments 77-79 of the balloon cover assembly.

[0241] Example 81. The locking ribs of the proximal balloon engagement surfaces of each of the pair of balloon cover clam shell portions are vibrated relative to each other such that the locking ribs of the proximal balloon engagement surfaces of each of the pair of balloon cover clam shell portions are alternately arranged relative to each other when the balloon cover assembly is operably coupled to the inflatable balloon, as described in any of the embodiments herein, particularly the balloon cover assembly described in Example 80.

[0242] Example 82. Each respective proximal balloon engagement surface of each of the pair of balloon cover clam shell portions is configured to engage with each other to mechanically hold the balloon cover clam shell portions relative to each other when the balloon cover assembly is operably coupled to the inflatable balloon, as described in any of the embodiments herein, particularly any one of embodiments 77-81 of the balloon cover assembly.

[0243] Example 83. The pair of balloon cover clam shell portions are configured to engage with each other when the balloon cover assembly is operably coupled to the inflatable balloon, as described in any of the embodiments herein, particularly any one of embodiments 76-80 of the balloon cover assembly.

[0244] Example 84. A pair of balloon cover clam shell portions are configured to abut each other when the balloon cover assembly is operably coupled to an inflatable balloon, the balloon cover assembly according to any one of the embodiments herein, particularly any one of embodiments 76 - 83.

[0245] Example 85. A pair of balloon cover clam shell portions are configured to fit together when the balloon cover assembly is operably coupled to an inflatable balloon, the balloon cover assembly according to any one of the embodiments herein, particularly any one of embodiments 76 - 84.

[0246] Example 86. The balloon cover assembly is configured to engage a compression alignment tool configured to receive a distal portion of a valve delivery device such that, as a result, when the balloon cover assembly is operably coupled to an inflatable balloon by the compression alignment tool operably coupled to the distal portion of the valve delivery device, the balloon cover assembly restricts removal of the compression alignment tool from the distal portion of the valve delivery device, the balloon cover assembly according to any one of the embodiments herein, particularly any one of embodiments 76 - 85.

[0247] Example 87. The compression alignment tool includes a clam shell engagement mechanism and each balloon cover clam shell portion includes a compression alignment tool engagement mechanism configured to engage the clam shell engagement mechanism when the balloon cover assembly is operably engaged with the compression alignment tool, the balloon cover assembly according to any one of the embodiments herein, particularly the balloon cover assembly according to embodiment 86.

[0248] Example 88. The clam shell engagement mechanism comprises an annular groove, and each compression alignment tool engagement mechanism comprises engagement teeth configured to be received within a portion of the annular groove to limit axial translation of the compression alignment tool relative to the balloon cover assembly when the balloon cover assembly is operably engaged with the compression alignment tool, of any embodiment of the present specification, particularly the balloon cover assembly described in embodiment 87.

[0249] Embodiment 89. A method of attaching a transplantable artificial valve to a valve delivery device, comprising inserting a balloon catheter of the valve delivery device into a central passage of a frame of the transplantable artificial valve, partially compressing an annular frame of the transplantable artificial valve by a compressor assembly, operably coupling a compression alignment tool to a distal portion of the valve delivery device to position the compression alignment tool in an alignment configuration relative to the valve delivery device, positioning the transplantable artificial valve to engage the compression alignment tool, and fully compressing the annular frame of the transplantable artificial valve, wherein the compressor assembly is a compressor assembly described in any one of embodiments 25 - 43 of the present specification, the valve delivery device is a valve delivery device described in any one of embodiments 43 - 57 of the present specification, and the compression alignment tool is a compression alignment tool described in any one of embodiments 58 - 74 of the present specification, of one or more of them, a method.

[0250] Embodiment 90. Partially compressing the annular frame of the transplantable artificial valve includes radially compressing the transplantable artificial valve to make the annular frame have a diameter at least substantially equal to a first stop diameter, and fully compressing the annular frame of the transplantable artificial valve includes radially compressing the transplantable artificial valve to make the annular frame have a diameter at least substantially equal to a second stop diameter smaller than the first stop diameter, of any embodiment of the present specification, particularly the method described in embodiment 89.

[0251] Embodiment 91. Partially compressing the annular frame involves transitioning the implantable prosthetic valve to an intermediate configuration where the implantable prosthetic valve engages an inflatable balloon of a valve delivery device. As a result, the implantable prosthetic valve is at least partially fixed in position relative to the inflatable balloon, unless the implantable prosthetic valve is intentionally repositioned by the user. Positioning the implantable prosthetic valve to engage a compression alignment tool is performed by the implantable prosthetic valve in the intermediate configuration, as described in any of the embodiments herein, particularly the method described in Embodiment 90.

[0252] Embodiment 92. The valve delivery device further includes a balloon cover assembly operably coupled to the inflatable balloon of the valve delivery device. The balloon cover assembly includes a pair of balloon cover clam shell portions attached to opposite sides of the inflatable balloon and a balloon cover sleeve surrounding the pair of balloon cover clam shell portions to hold the balloon cover clam shell portions against the inflatable balloon. The method further includes removing the balloon cover assembly from the inflatable balloon before inserting the balloon catheter into the frame central passageway, as described in any of the embodiments herein, particularly any one of Embodiments 89 - 91.

[0253] Embodiment 93. Removing the balloon cover assembly from the inflatable balloon includes removing the balloon cover sleeve from the pair of balloon cover clam shell portions and, after removing the balloon cover sleeve, removing the pair of balloon cover clam shell portions from the inflatable balloon, as described in any of the embodiments herein, particularly the method described in Embodiment 92.

[0254] Embodiment 94. Operably coupling a compression alignment tool to the distal portion of the valve delivery device includes engaging the distal portion of the valve delivery device with the compression alignment tool to position the compression alignment tool in an alignment configuration, as described in any of the embodiments herein, particularly any one of Embodiments 89 - 93.

[0255] Example 95. Operably coupling a compression alignment tool to a distal portion of a valve delivery device includes axially advancing the compression alignment tool toward an inflatable balloon until further axial advancement of the compression alignment tool is restricted, according to any of the embodiments herein, particularly the method described in any one of Examples 89-94.

[0256] Example 96. Operably coupling a compression alignment tool to a distal portion of a valve delivery device includes engaging a stylet of the valve delivery device with a distal end of the compression alignment tool, according to any of the embodiments herein, particularly the method described in any one of Examples 89-95.

[0257] Example 97. The distal end of the compression alignment tool includes a distal opening, and engaging the stylet includes at least partially inserting the stylet through the distal opening, according to any of the embodiments herein, particularly the method described in Example 96.

[0258] Example 98. The compression alignment tool includes a distal alignment indicator configured to provide a visual indication that the compression alignment tool is in an aligned configuration relative to the valve delivery device, and operably coupling the compression alignment tool to a distal portion of the valve delivery device includes visually verifying an axial position relative to the distal alignment indicator of the valve delivery device, according to any of the embodiments herein, particularly the method described in any one of Examples 89-97.

[0259] Example 99. The distal alignment indicator includes a window that enables visual inspection of the valve delivery device by the compression alignment tool, and visually verifying the axial position includes verifying that components of the valve delivery device are axially aligned with one or both of a distal edge and a proximal edge of the window, according to any of the embodiments herein, particularly the method described in Example 98.

[0260] Example 100. The components of the valve delivery device are the methods described in any of the embodiments herein, particularly embodiment 99, which is the proximal edge of the stylet of the valve delivery device.

[0261] Example 101. The distal alignment indicator includes one or more visual marks, and verifying the axial position includes verifying that the components of the valve delivery device are axially aligned with the visual marks, as described in any of the embodiments herein, particularly any one of embodiments 98 - 100.

[0262] Example 102. Further comprising operably coupling a first compression stop of the compression assembly to a second compression stop of the compression assembly before partially compressing the annular frame of the implantable artificial valve, as described in any of the embodiments herein, particularly any one of embodiments 89 - 101.

[0263] Example 103. The first compression stop includes a second compression stop receiver configured to receive a portion of the second compression stop, and operably coupling the first compression stop to the second compression stop includes inserting the second compression stop into the second compression stop receiver, as described in any of the embodiments herein, particularly embodiment 102.

[0264] Example 104. Partially compressing the annular frame of the implantable artificial valve includes directly engaging the implantable artificial valve with the jaws of the compression assembly, as described in any of the embodiments herein, particularly any one of embodiments 89 - 103.

[0265] Example 105. Partially compressing the annular frame of a transplantable artificial valve involves positioning the transplantable artificial valve within the compressor opening of the compressor assembly and operating the actuator handle of the compressor assembly to engage the first compression stop, with the second compression stop of the compressor assembly fixedly coupled to the housing of the compressor assembly and the first compression stop of the compressor assembly operably coupled to the second compression stop. This is the method described in any of the embodiments herein, particularly any one of embodiments 89 - 104.

[0266] Example 106. Positioning a transplantable artificial valve within the compressor opening involves positioning it such that the overall valve length of the transplantable artificial valve is contained within the compressor opening length of the compressor opening. This is the method described in any of the embodiments herein, particularly embodiment 105.

[0267] Example 107. Positioning a transplantable artificial valve relative to a compression alignment tool involves axially translating the transplantable artificial valve relative to the valve delivery device such that the distal frame end of the annular frame engages the valve stop of the compression alignment tool. This is the method described in any of the embodiments herein, particularly any one of embodiments 89 - 106.

[0268] Example 108. Before fully compressing the annular frame of a transplantable artificial valve, further includes removing the first compression stop of the compressor assembly from the second compression stop of the compressor assembly. This is the method described in any of the embodiments herein, particularly any one of embodiments 89 - 107.

[0269] Example 109. The first compression stop portion includes a gripping mechanism configured to facilitate removal of the first compression stop portion from the second compression stop portion. Removing the first compression stop portion from the second compression stop portion involves gripping the gripping mechanism for one or both of pivoting the first compression stop portion relative to the second compression stop portion and pulling the first compression stop portion away from the second compression stop portion, as described in any of the embodiments herein, particularly the method described in Embodiment 108.

[0270] Embodiment 110. Completely compressing the annular frame of a transplantable artificial valve includes engaging the transplantable artificial valve directly with the jaws of a compression assembly, as described in any of the embodiments herein, particularly any one of Embodiments 89 - 109.

[0271] Embodiment 111. Completely compressing the annular frame of a transplantable artificial valve includes positioning the transplantable artificial valve within the compression opening of a compression assembly with the second compression stop portion of the compression assembly fixedly coupled to the housing of the compression assembly and the first compression stop portion of the compression assembly removed from the second compression stop portion, and actuating the actuator handle of the compression assembly to engage the second compression stop portion, as described in any of the embodiments herein, particularly any one of Embodiments 89 - 110.

[0272] Embodiment 112. Positioning a transplantable artificial valve within a compression opening includes positioning the valve such that the overall length of the valve is contained within the length of the compression opening of the compression opening, as described in any of the embodiments herein, particularly the method described in Embodiment 111.

[0273] Embodiment 113. After actuating the actuator handle to engage the second compression stop, actuating the actuator handle to release the plurality of jaw portions of the compressor assembly from the implantable prosthetic valve, and repeating the act of actuating the actuator handle to engage the second compression stop and actuating the actuator handle to release the jaw portions from the implantable prosthetic valve, the method according to any one of the embodiments herein, particularly any one of embodiments 111 - 112.

[0274] Example 114. Repeating includes repeating such that actuating the actuator handle to engage the second compression stop is performed at least two, at least three, at least four, and up to five times, one or more of which is performed, the method according to any one of the embodiments herein, particularly the method described in embodiment 113.

[0275] Example 115. Further including removing the compression alignment tool from the valve delivery device after completely compressing the annular frame, the method according to any one of the embodiments herein, particularly any one of embodiments 89 - 114.

[0276] Example 116. Further including removing the stylet of the valve delivery device from the nose piece of the valve delivery device after removing the compression alignment tool from the valve delivery device, the method according to any one of the embodiments herein, particularly any one of embodiments 89 - 115.

[0277] Example 117. One or more components of the valve preparation assembly are sterilized, the prosthetic valve preparation assembly according to any one of the embodiments herein, particularly any one of embodiments 1 - 14.

[0278] Example 118. A method including sterilizing one or more components of the valve preparation assembly according to any one of the embodiments herein, particularly any one of embodiments 1 - 14.

[0279] Example 119. The compression alignment tool is sterilized, and is the compression alignment tool described in any one of the embodiments herein, particularly any one of Embodiments 15 to 18.

[0280] Example 120. A method comprising sterilizing the compression alignment tool described in any one of the embodiments herein, particularly any one of Embodiments 15 to 18.

[0281] Example 121. One or more components of the compressor assembly are sterilized, and are the compressor assembly described in any one of the embodiments herein, particularly any one of Embodiments 25 to 43.

[0282] Example 122. A method comprising sterilizing one or more components of the compressor assembly described in any one of the embodiments herein, particularly any one of Embodiments 25 to 43.

[0283] Example 123. One or more components of the valve delivery device are sterilized, and are the valve delivery device described in any one of the embodiments herein, particularly any one of Embodiments 44 to 58.

[0284] Example 124. A method comprising sterilizing one or more components of the valve delivery device described in any one of the embodiments herein, particularly any one of Embodiments 44 to 58.

[0285] Example 125. The compression alignment tool is sterilized, and is the compression alignment tool described in any one of the embodiments herein, particularly any one of Embodiments 59 to 75.

[0286] Example 126. A method comprising sterilizing the compression alignment tool described in any one of the embodiments herein, particularly any one of Embodiments 59 to 75.

[0287] Example 127. One or more components of the balloon cover assembly are sterilized, the balloon cover assembly described in any of the examples herein, particularly any one of Examples 76-88.

[0288] Example 128. A method comprising sterilizing one or more components of the balloon cover assembly described in any of the examples herein, particularly any one of Examples 76-88.

[0289] For any feature described herein with respect to any example, unless otherwise stated, it can be combined with any one or more of the other features described in any one or more of the other examples. For example, any one or more of the features of one artificial valve preparation system can be combined with any one or more of the features of another artificial valve preparation system. As another example, any one or more of the features of one compressor assembly can be combined with any one or more of the features of another compressor assembly.

[0290] Considering the many possible aspects to which the principles of the present disclosure can be applied, it should be recognized that the illustrated configurations are shown as examples of the disclosed technology and should not be construed as limiting the scope of the present disclosure or the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

1. A compressor assembly product, An actuator handle configured to be manually actuated to compress a transplantable artificial valve around a valve delivery device, A second compression stop portion defining the entire movable range of the actuator handle, A first compression stop portion defining a partial movable range of the actuator handle and configured to be selectively and operably coupled to the second compression stop portion, the compressor assembly product comprising the first compression stop portion.

2. A base, A housing fixedly attached to the base and defining a central axis of the compressor assembly product, A plurality of concentric jaws arranged circumferentially and supported within the housing, the jaws being movable radially within the housing away from the central axis towards the central axis, the plurality of jaws collectively defining a compressor opening whose diameter changes as the jaws move away from the central axis towards the central axis, the compressor assembly product according to claim 1, further comprising the concentric jaws.

3. The compressor assembly product according to claim 2, wherein the actuator handle is movable relative to the housing to move the jaws away from the central axis towards the central axis.

4. The compressor assembly product according to any one of claims 1 to 3, wherein the second compression stop portion is fixedly coupled to the housing during use of the compressor assembly product.

5. When the first compression stop portion is operably coupled to the second compression stop portion, the compressor opening is operated to a first stop diameter by actuating the actuator handle to engage the first compression stop portion, When the first compression stop portion is removed from the second compression stop portion, the compressor opening is operated to a second stop diameter smaller than the first stop diameter by actuating the actuator handle to engage the second compression stop portion, the compressor assembly product according to any one of claims 1 to 4.

6. The compressor assembly product according to any one of claims 1 to 5, wherein the compressor opening extends along a compressor opening length greater than or equal to the valve length of the transplantable artificial valve, measured along a direction parallel to the central axis of the compressor assembly product.

7. The first compression stop portion defines a terminal end of the first compression stop portion and includes a body of the first compression stop portion that terminates at the terminal end of the first compression stop portion. The compressor assembly is configured such that the actuator handle engages the terminal end of the first compression stop portion during use of the compressor assembly and when the first compression stop portion is operably coupled to the second compression stop portion. The compressor assembly according to any one of claims 1 to 6.

8. The second compression stop portion defines a terminal end of the second compression stop portion and includes a body of the second compression stop portion that terminates at the terminal end of the second compression stop portion. The compressor assembly is configured such that the actuator handle engages the terminal end of the second compression stop portion during use of the compressor assembly and when the first compression stop portion is removed from the second compression stop portion. The compressor assembly according to any one of claims 1 to 7.

9. The first compression stop portion includes a second compression stop receiver configured to receive, optionally, a portion of the second compression stop portion and the terminal end of the second compression stop portion of the body of the second compression stop portion when the first compression stop portion is operably coupled to the second compression stop portion. The compressor assembly according to any one of claims 1 to 8.

10. The second compression stop receiver includes a receiver channel configured to receive an elongate portion of the second compression stop portion when the first compression stop portion is operably coupled to the second compression stop portion. The compressor assembly according to claim 9.

11. The first compression stop portion includes a gripping mechanism configured to facilitate removal of the first compression stop portion from the second compression stop portion. The compressor assembly according to any one of claims 1 to 10.

12. The gripping mechanism is configured to be gripped by a user to enable the user to apply torque to the first compression stop portion to remove the first compression stop portion from the second compression stop portion. The compressor assembly according to claim 11.

13. The gripping mechanism is configured to be gripped by a user to enable the user to pull the first compression stop portion away from the second compression stop portion. The compressor assembly according to claim 11.

14. The compression assembly product according to claim 11, wherein the gripping mechanism includes one or more of a tab, a lever, a protrusion, and a depression.

15. The compression assembly product according to any one of claims 1 to 14, wherein during use of the compression assembly product, the second compression stop portion is coupled to one or both of the base portion and the housing at a compression stop attachment position.

16. The compression assembly product according to claim 15, wherein the second compression stop portion is not configured to be removed from the compression stop attachment position without damaging the compression assembly product.

17. The compression assembly product according to claim 15, wherein the second compression stop portion is configured to be selectively and repeatedly coupled to the compression stop attachment position and removed from the compression stop attachment position without damaging the compression assembly product.

18. A base portion, A housing fixedly attached to the base portion and defining a central axis of the compression assembly product, A plurality of nested jaw portions supported within the housing and arranged circumferentially, wherein the jaw portions are movable radially within the housing away from the central axis toward the central axis, and the plurality of jaw portions collectively define a compression opening whose diameter changes when the jaw portions move away from the central axis toward the central axis, and further comprising a nested jaw portion. The compression assembly product according to claim 15, wherein one or both of the base portion and the housing include a compression stop receiver defining the compression stop attachment position.

19. A method of attaching a transplantable artificial valve to a valve delivery device, comprising: Inserting a balloon catheter of the valve delivery device into a central passage of a frame of the transplantable artificial valve; Partially compressing an annular frame of the transplantable artificial valve by a compression assembly product; Operably coupling a compression alignment tool to a distal portion of the valve delivery device to position the compression alignment tool in an alignment configuration with respect to the valve delivery device; Positioning the transplantable artificial valve to engage the compression alignment tool; and Fully compressing the annular frame of the transplantable artificial valve.

20. The compression assembly product includes An actuator handle configured to be manually actuated to compress the transplantable artificial valve around the valve delivery device. a second compression stop that defines the entire movable range of the actuator handle; a first compression stop that defines a partial movable range of the actuator handle and is configured to be selectively and operably coupled to the second compression stop; partially compressing the annular frame includes actuating the actuator handle to engage the first compression stop with the second compression stop operably coupled thereto; fully compressing the annular frame includes actuating the actuator handle to engage the second compression stop; The method of claim 19 further comprising removing the first compression stop from the second compression stop after partially compressing the annular frame and before fully compressing the annular frame.

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