Cover for a medical balloon

Abstract

A balloon cover (300) for a catheter balloon is disclosed. The balloon cover (300) comprises a first housing component (310) and a second housing component (320), wherein a distal end portion (314) of the first housing component (310) is adapted to be releasably coupled to a proximal end portion (326) of the second housing component (320). The first housing component (310) and the second housing component (320) each comprise a complete annular body. The first housing component (310) and the second housing component (320) are coupled and decoupled from each other by moving the first housing component and the second housing component along their longitudinal axes (312, 322). A method of assembling and disassembling the balloon cover (300) over the catheter balloon is further disclosed.

Description

COVER FOR A MEDICAL BALLOON CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Application No.63 / 671,346, filed July 15, 2024, which is incorporated by reference herein in its entirety. FIELD

[0002] The present disclosure relates to covers for inflatable medical balloons. BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable.

[0004] In a specific example, a prosthetic heart valve can be mounted in a crimped state on a distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.

[0005] Inflatable medical balloons, in some examples, can have pleats that enable folding of the balloon in compact manner when the balloon is deflated, for example, for storage and shipping, for delivery through a patient’s vasculature, and / or while preparing the delivery apparatus for an implantation procedure. Covers can be used to both protect the inflatable balloon and retain the balloon in a compact, folded state. When the cover is placed over the balloon, care must be taken to avoid pinching and causing any damage to the balloon. Thus,a need exists for a balloon cover that is easy to use while also avoiding any damage to the balloon. SUMMARY

[0006] Described herein are prosthetic heart valves, delivery apparatuses, and methods for implanting prosthetic heart valves. Also described herein are inflatable medical balloons (also referred to herein as “balloons” or “catheter balloons”) used to deploy prosthetic implants, covers for balloons, and methods for assembling covers over and removing covers from balloons. The disclosed covers and methods can, for example, provide protection for a balloon, while minimizing the likelihood that the inflatable balloon can be damaged by the cover. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves, balloon covers, and their delivery apparatuses.

[0007] A balloon cover for a catheter balloon can comprise a first housing component and a second housing component. In addition to these components, a balloon cover can further comprise one or more of the components disclosed herein.

[0008] In some examples, a distal end portion of the first housing component can be adapted to be releasably coupled to a proximal end portion of the second housing component.

[0009] In some examples, the first housing component can comprise a first cavity adapted to receive a proximal portion of the catheter balloon.

[0010] In some examples, the second housing component can comprise a second cavity adapted to receive a distal portion of the catheter balloon.

[0011] In some examples, the first cavity, the second cavity, or both the first cavity and the second cavity can be adapted to receive a portion of a balloon catheter other than the balloon.

[0012] In some examples, the first cavity, the second cavity, or both the first cavity and the second cavity can be adapted to receive a portion of the catheter balloon having a varying outer diameter.

[0013] In some examples, the first cavity, the second cavity, or both the first cavity and the second cavity can be adapted to receive a bulbous shaped section of the catheter balloon.

[0014] In some examples, the first cavity, the second cavity, or both the first cavity and the second cavity can be adapted to receive a portion of the catheter balloon having a constant outer diameter.

[0015] In some examples, the first cavity can be defined by a first inner surface and the second cavity can be defined by a second inner surface, wherein the first and second innersurfaces can be configured to provide a gap between an outer surface of the catheter balloon and the first and second inner surfaces when the first and second housing components are coupled to each other.

[0016] In some examples, the first housing component can have a first longitudinal axis and the second housing component can have a second longitudinal axis, wherein the first longitudinal axis and the second longitudinal axis can be colinear when the first housing component and the second housing component are coupled to each other.

[0017] In some examples, the first housing component and the second housing component can be configured to be decoupled from each other by moving the first and second housing components in opposite directions along the first longitudinal axis and the second longitudinal axis.

[0018] In some examples, the distal end portion of the first housing component can comprise a first coupling feature and the proximal end portion of the second housing component can comprise a second coupling feature, wherein the first coupling feature can be adapted to engage the second coupling feature to couple the first and second housing components to each other.

[0019] In some examples, the first and second coupling features can be adapted to form a snap-fit connection.

[0020] In some examples, the first housing component can comprise a complete annular body.

[0021] In some examples, the second housing component can comprise a complete annular body.

[0022] In some examples, a balloon cover for a catheter balloon comprises a first housing component, and a second housing component, wherein a distal end portion of the first housing component is adapted to be releasably coupled to a proximal end portion of the second housing component.

[0023] In some examples, a balloon cover for a catheter balloon comprises one or more of the components recited in Examples 1-14 and 28 below.

[0024] An assembly can comprise a balloon catheter comprising a shaft and a balloon, and a cover surrounding the balloon. In addition to these components, an assembly can further comprise one or more of the components disclosed herein.

[0025] In some examples, the cover can comprise a first, proximal housing component.

[0026] In some examples, the cover can comprise a second, distal housing component coupled to the first, proximal housing component.

[0027] In some examples, the first, proximal housing component and the second, distal housing component can be separable from each other to uncover the balloon by moving the first, proximal housing component and the second, distal housing component in opposite directions along a longitudinal axis of the balloon catheter.

[0028] In some examples, the balloon can have a proximal portion and a distal portion, and the first, proximal housing component can have a first cavity having a shape that corresponds to a shape of the proximal portion of the balloon and the second, distal housing component can have a second cavity having a shape that corresponds to a shape of the distal portion of the balloon.

[0029] In some examples, the first, proximal housing component can completely surround the proximal portion of the balloon.

[0030] In some examples, the second, distal housing component can completely surround the distal portion of the balloon.

[0031] In some examples, the first cavity, the second cavity, or both the first and second cavities can have a shape that is adapted to receive a portion of the balloon catheter other than the balloon.

[0032] In some examples, an assembly comprises a balloon catheter comprising a shaft and a balloon, a cover surrounding the balloon, wherein the cover comprises a first, proximal housing component and a second, distal housing component coupled to the first, proximal housing component. The first, proximal housing component and the second, distal housing component are separable from each other to uncover the balloon by moving the first, proximal housing component and the second, distal housing component in opposite directions along a longitudinal axis of the balloon catheter.

[0033] In some examples, an assembly comprises one or more of the components recited in Examples 15-19 below.

[0034] A method can comprise positioning a first housing component of a cover over a proximal portion of a balloon of a balloon catheter. In addition to this step, a method can further comprise one or more of the steps disclosed herein.

[0035] In some examples, the method can further comprise positioning a second housing component of the cover over a distal portion of the balloon.

[0036] In some examples, the method can further comprise coupling a proximal end portion of the second housing component to a distal end portion of the first housing component.

[0037] In some examples, the method can further comprise moving the first housing component in a proximal-to-distal direction along a longitudinal axis of the balloon catheter.

[0038] In some examples, the method can further comprise positioning second housing over the distal portion of the balloon comprising moving the second housing component in a distal-to-proximal direction along a longitudinal axis of the balloon catheter.

[0039] In some examples, the method can further comprise forming a snap-fit connection between the second housing component and the first housing component.

[0040] In some examples, the method can further comprise removing the second housing component from the first housing component in a direction along the longitudinal axis of the balloon catheter.

[0041] In some examples, the first housing component can comprise a complete annular body.

[0042] In some examples, the second housing component can comprise a complete annular body.

[0043] In some examples, a method comprises positioning a first housing component of a cover over a proximal portion of a balloon of a balloon catheter, positioning a second housing component of the cover over a distal portion of the balloon, and coupling a proximal end portion of the second housing component to a distal end portion of the first housing component.

[0044] In some examples, a method of one or more of the steps recited in Examples 20-27 below.

[0045] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] FIG.1 is a side view of a prosthetic heart valve, according to an example.

[0047] FIG.2 is a side view of a delivery apparatus for a prosthetic heart valve, according to an example, where the delivery apparatus comprises a balloon catheter.

[0048] FIG.3 is an enlarged, side view of the distal end portion of the balloon catheter of FIG. 2, showing details of the balloon.

[0049] FIG.4 is a cross-sectional view of a balloon cover, according to an example.

[0050] FIG.5 is a side view of the balloon cover of FIG. 4 during assembly over the balloon of FIG.3.

[0051] FIG.6 is a side view of the balloon cover of FIG.4 after assembly over the balloon of FIG.3. DETAILED DESCRIPTION General Considerations

[0052] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0053] Although the operations of some of the disclosed examples are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0054] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0055] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein,the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0056] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Overview of the Disclosed Technology

[0057] Described herein are examples of a delivery apparatus that can be used to navigate a subject’s vasculature to deliver an implantable, expandable medical device (for example, a prosthetic heart valve, stent, or graft), tools, agents, or other therapy to a location within the body of a subject. Examples of procedures in which the delivery apparatuses are useful include neurological, urological, gynecological, fertility (for example, in vitro fertilization, artificial insemination), laparoscopic, arthroscopic, transesophageal, transvaginal, transvesical, transrectal, and procedures including access in any body duct or cavity. Particular examples include placing implants, including stents, grafts, embolic coils, and the like; positioning imaging devices and / or components thereof, including ultrasound transducers; and positioning energy sources, for example, for performing lithotripsy, RF sources, ultrasound emitters, electromagnetic sources, laser sources, thermal sources, and the like.

[0058] As introduced above, prosthetic implants, such as prosthetic heart valves, can be crimped onto inflatable balloons for delivery through a patient’s vasculature in a crimped state. The prosthetic implant can be expanded to a functional size at an implantation site, for example, by inflating a balloon on which the prosthetic implant is mounted.

[0059] During the manufacturing process, the balloon can be placed in a folded or pleated state. As described above, the pleats enable folding of the balloon into a reduced outer profile for storage, shipping, crimping, and delivery into a body. Covers can be used to protect the balloon from damage (for instance, abrasions, nicks, or tears) as well as maintain the pleats in place during storage and shipping.

[0060] In an exemplary example, an implantable medical device can be a prosthetic heart valve as seen in FIG.1, where the prosthetic heart valve comprises a frame, leaflets secured on an inside of the frame, and an outer skirt disposed around an outer surface of the frame. FIG.2 illustrates an example of a delivery apparatus for a prosthetic heart valve, where thedelivery apparatus comprises a balloon catheter with an inflatable balloon (also referred to herein as a “balloon” or a “catheter balloon”).

[0061] FIG.3 shows a distal end portion of the balloon catheter of FIG.2, where the balloon is mounted to a balloon shaft and shown in a folded configuration with pleats.

[0062] FIG.4 shows an example of a balloon cover, where the balloon cover comprises a first, proximal housing component and a second, distal housing component. The first, proximal housing component and the second, distal housing component are configured to be coupled to each other to cover the balloon, as illustrated in FIG.5. FIG.6 shows the balloon cover after assembly over the balloon. Examples of the Disclosed Technology

[0063] Prosthetic implants (e.g., prosthetic valves, stents, grafts, etc.) disclosed herein can be radially compressible and expandable between a radially compressed state and a radially expanded state. Thus, the prosthetic implants (also referred to herein as “implantable medical devices”) can be crimped on or retained by an implant delivery apparatus in the radially compressed state while being advanced through a patient’s vasculature on the delivery apparatus. The prosthetic implant can be expanded to the radially expanded state (e.g., a deployed state) once the prosthetic implant reaches an implantation site. It is understood that the prosthetic implants disclosed herein may be used with a variety of implant delivery apparatuses and can be implanted via various delivery procedures, examples of which will be discussed in more detail below.

[0064] FIG.1 shows an exemplary prosthetic implant in the form of a prosthetic valve 100, according to an example. Although the examples described herein are primarily directed to prosthetic heart valves, the disclosed devices and methods can be used with various other prosthetic implants, including, for instance, stents and grafts.

[0065] Any of the prosthetic valves disclosed herein are adapted to be implanted in the native aortic annulus, although in some examples they can be adapted to be implanted in the other native annuluses of the heart (the pulmonary, mitral, and tricuspid valves). The disclosed prosthetic valves also can be implanted within vessels communicating with the heart, including a pulmonary artery (for replacing the function of a diseased pulmonary valve, or the superior vena cava or the inferior vena cava (for replacing the function of a diseased tricuspid valve) or various other veins, arteries, and vessels of a patient. The disclosed prosthetic valves also can be implanted within a previously implanted prosthetic valve (which can be a prosthetic surgical valve or a prosthetic transcatheter heart valve) in a valve-in-valve procedure.

[0066] In some examples, the disclosed prosthetic valves can be implanted within a docking or anchoring device that is implanted within a native heart valve or a vessel. For example, the disclosed prosthetic valves can be implanted within a docking device implanted within the pulmonary artery for replacing the function of a diseased pulmonary valve, such as disclosed in U.S. Publication No.2017 / 0231756, which is incorporated by reference herein. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within or at the native mitral valve, such as disclosed in PCT Publication No. WO2020 / 247907, which is incorporated herein by reference. In some examples, the disclosed prosthetic valves can be implanted within a docking device implanted within the superior or inferior vena cava for replacing the function of a diseased tricuspid valve, such as disclosed in U.S. Publication No.2019 / 0000615, which is incorporated by reference herein.

[0067] The prosthetic valve 100 can comprise a frame 112, a valvular structure 114, an inner skirt 116, and a perivalvular outer sealing member or outer skirt 118. The prosthetic valve 100 can comprise an inflow end portion 115 and an outflow end portion 119, and an intermediate portion 117 extending therebetween.

[0068] The valvular structure 114 can comprise a plurality of leaflets 140 collectively forming a leaflet structure. In some examples, the valvular structure 114 can comprise three leaflets 140 arranged in a tricuspid arrangement. However, there can be a greater or fewer number of leaflets 140. The leaflets can be secured to one another at their adjacent sides to form commissures 122 of the valvular structure 114. The lower edge of the valvular structure 114 can have an undulating, curved scalloped shape, and can be secured to the inner skirt 116 by sutures (not shown). In some examples, the leaflets 140 can be formed of pericardial tissue (such as bovine pericardial tissue), biocompatible synthetic materials, or other various suitable natural or synthetic materials as known in the art and described in U.S. Patent No. 6,730,118, which is incorporated by reference herein.

[0069] The frame 112 can be made of any of various suitable plastically-expandable materials (for example, stainless steel, etc.) or self-expanding materials (for example, Nitinol) as known in the art. When constructed of a plastically-expandable material, the frame 112 (and thus the valve 100) can be crimped to a radially compressed state on a delivery catheter and then expanded inside a patient by an inflatable catheter balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame 112 (and thus the valve 100) can be crimped to a radially compressed state and restrained in the compressed state by insertion into a sheath or equivalent mechanism of a delivery catheter. Once insidethe body, the valve can be advanced from the delivery sheath, which allows the valve to expand to its functional size.

[0070] Suitable plastically-expandable materials that can be used to form the frames disclosed herein (for example, the frame 112) include, metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the frame 112 can comprise stainless steel. In some examples, the frame 112 can comprise cobalt-chromium. In some examples, the frame 112 can comprise nickel-cobalt- chromium. In some examples, the frame 112 comprises a nickel-cobalt-chromium- molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0071] The inner skirt 116 and / or the outer skirt 118 can be wholly or partly formed of any suitable biological material, synthetic material (for example, any of various polymers), or combinations thereof. In some examples, the skirts 116, 118 can comprise a fabric having interlaced yarns or fibers, such as in the form of a woven, braided, or knitted fabric. In some examples, the fabric can have a plush nap or pile. Exemplary fabrics having a plus nap or pile include velour, velvet, velveteen, corduroy, terrycloth, fleece, etc. In some examples, the skirts 116, 118 can comprise a fabric without interlaced yarns or fibers or randomly interlaced yarns or fibers, such as felt or an electrospun fabric. Exemplary materials that can be used for forming such fabrics (with or without interlaced yarns or fibers) include, without limitation, polyethylene (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyamide etc. In some examples, the skirts 116, 118 can comprise a non-textile or non-fabric material, such as a film made from any of a variety of polymeric materials, such as PTFE, PET, polypropylene, polyamide, polyetheretherketone (PEEK), polyurethane (such as thermoplastic polyurethane (TPU)), etc. In some examples, the skirts 116, 118 can comprise a sponge material or foam, such as polyurethane foam. In some examples, the skirts 116, 118 can comprise natural tissue, such as pericardium (for example, bovine pericardium, porcine pericardium, equine pericardium, or pericardium from other sources).

[0072] FIG.2 shows a delivery apparatus 200, according to an example, in the form of a balloon catheter that can be used to implant a prosthetic medical device. In some examples, the delivery apparatus 200 can be used to implant an expandable prosthetic heart valve (for example, the prosthetic heart valve 100 of FIG.1 and / or any of the other prosthetic heartvalves described herein, or other types of implants). In some examples, the delivery apparatus 200 can be specifically adapted for use in introducing a prosthetic heart valve into a heart.

[0073] The delivery apparatus 200 in the illustrated example of FIG.2 comprises a handle 202 and a steerable, outer shaft 204 extending distally from the handle 202. The delivery apparatus 200 can further comprise an intermediate shaft 206 (also referred to herein as a “balloon shaft”) that extends proximally from the handle 202 and distally from the handle 202, the portion extending distally from the handle 202 also extending coaxially through the outer shaft 204. Additionally, the delivery apparatus 200 can further comprise an inner shaft 208 extending distally from the handle 202 coaxially through the intermediate shaft 206 and the outer shaft 204 and proximally from the handle 202 coaxially through the intermediate shaft 206.

[0074] The outer shaft 204 and the intermediate shaft 206 can be configured to translate (for example, move) longitudinally, along a central longitudinal axis 220 of the delivery apparatus 200, relative to one another to facilitate delivery and positioning of a prosthetic heart valve at an implantation site in a patient’s body.

[0075] The intermediate shaft 206 can include a proximal end portion 210 that extends proximally from a proximal end of the handle 202, to an adaptor 212. A rotatable knob 214 can be mounted on the proximal end portion 210 and can be configured to rotate the intermediate shaft 206 around the central longitudinal axis 220 and relative to the outer shaft 204.

[0076] The adaptor 212 can include a first port 238 configured to receive a guidewire therethrough and a second port 240 configured to receive fluid (for example, inflation fluid) from a fluid source. The second port 240 can be fluidly coupled to an inner lumen of the intermediate shaft 206.

[0077] The balloon shaft 206 can further include a distal end portion that extends distally beyond a distal end of the outer shaft 204 when a distal end of the outer shaft 204 is positioned away from an inflatable catheter balloon 218 (also referred to herein as a “balloon” or an “inflatable balloon”) of the delivery apparatus 200. A distal end portion of the inner shaft 208 can extend distally beyond the distal end portion of the balloon shaft 206.

[0078] A proximal end 242 of the balloon 218 can be coupled to the distal end portion of the balloon shaft 206. In some examples, a distal end 244 of the balloon 218 can be coupled to a distal end of the delivery apparatus 200, such as to a nose cone 222 (as shown in FIGS.2-3). An intermediate portion of the catheter balloon 218 can overlay a valve mounting portion 224of a distal end portion of the delivery apparatus 200. The valve mounting portion 224 and the intermediate portion of the catheter balloon 218 can be configured to receive a prosthetic heart valve in a radially compressed (e.g., crimped) state. For example, as shown schematically in FIG.2, a prosthetic heart valve 250 (which can be any of the prosthetic heart valves described herein) can be mounted around the catheter balloon 218, at the valve mounting portion 224 of the delivery apparatus 200.

[0079] As seen in FIG.2, the outer shaft 204 can include a distal tip portion 228 mounted on its distal end. The outer shaft 204 and the intermediate shaft 206 can be translated axially relative to one another to position the distal tip portion 228 adjacent to a proximal end of the valve mounting portion 224, when a prosthetic heart valve 250 is mounted in the radially compressed state on the valve mounting portion 224 (as shown in FIG.2) and during delivery of the prosthetic heart valve to the target implantation site. As such, the distal tip portion 228 can be configured to resist movement of the prosthetic heart valve 250 relative to the catheter balloon 218 proximally, in the axial direction, relative to the catheter balloon 218, when the distal tip portion 228 is arranged adjacent to a proximal side of the valve mounting portion 224.

[0080] An annular space can be defined between an outer surface of the inner shaft 208 and an inner surface of the intermediate shaft 206 and can be configured to receive fluid from a fluid source via the second port 240 of the adaptor 212. The annular space can be fluidly coupled to a fluid passageway formed between the outer surface of the distal end portion of the inner shaft 208 and an inner surface of the catheter balloon 218. As such, fluid from the fluid source can flow to the fluid passageway from the annular space to inflate the catheter balloon 218 and radially expand and deploy the prosthetic heart valve 250.

[0081] An inner lumen of the inner shaft can be configured to receive a guidewire therethrough, for navigating the distal end portion of the delivery apparatus 200 to the target implantation site.

[0082] The handle 202 can include a steering mechanism configured to adjust the curvature of the distal end portion of the delivery apparatus 200. In the illustrated example, for example, the handle 202 includes an adjustment member, such as the illustrated rotatable knob 260, which in turn is operatively coupled to the proximal end portion of a pull wire. The pull wire can extend distally from the handle 202 through the outer shaft 204 and has a distal end portion affixed to the outer shaft 204 at or near the distal end of the outer shaft 204. Rotating the knob 260 can increase or decrease the tension in the pull wire, thereby adjusting the curvature of the distal end portion of the delivery apparatus 200. Further details onsteering or flex mechanisms for the delivery apparatus can be found in U.S. Patent No. 9,339,384, which is incorporated by reference herein.

[0083] The handle 202 can further include an adjustment mechanism 261 including an adjustment member, such as the illustrated rotatable knob 262, and an associated locking mechanism including another adjustment member, configured as a rotatable knob 278. The adjustment mechanism 261 is configured to adjust the axial position of the balloon shaft 206 relative to the outer shaft 204 (for example, for fine positioning at the implantation site). Further details on the delivery apparatus 200 can be found in PCT Publication No. WO2022 / 046585, which is incorporated by reference herein.

[0084] FIG.3 shows a distal end portion of the delivery apparatus 200 and the balloon 218 of FIG.2. The balloon 218 is shown schematically with a plurality of pleats 270 (also referred to herein as “folds”) that extend longitudinally in a direction parallel to an axis 272 of the balloon shaft 206. The pleats 270 can be configured such that the balloon 218 can be folded in an orderly and compact manner for storage and shipping, for delivery through a patient’s vasculature, and / or while preparing the delivery apparatus for an implantation procedure. As shown in FIG.3, the pleats 270 can extend between the distal and proximal ends 244, 242, respectively, of the balloon 218. When in a folded configuration, the balloon 218 has a reduced outer profile onto which a prosthetic implant, such as a prosthetic valve, can be crimped using known techniques and crimping devices for insertion into a body.

[0085] In some examples, the outer profile of the balloon 218 in the folded configuration can have a substantially constant outer diameter between its distal and proximal ends 244, 242.

[0086] In some examples, the outer diameter of the outer profile of the balloon 218 can vary between the distal and proximal ends 244, 242, as shown in FIG.3. For example, a distal portion 274 of the balloon 218 can have a bulbous shape with a maximum diameter 279. The distal portion 274 can be shaped to accommodate a distal shoulder (not shown) mounted on the inner shaft 208. The distal shoulder functions to maintain a position of a crimped prosthetic valve relative to the balloon as the delivery apparatus and the prosthetic valve are advanced through a patient’s vasculature. A proximal portion 276 of the balloon 218 can have a constant intermediate diameter 280 extending a majority of the length of the proximal portion 276. The intermediate diameter 280 can taper to a smaller diameter at the proximal end 242, matching an outer diameter of the balloon shaft 206. The maximum diameter 279 can taper distally toward the nose cone 222 and can taper proximally toward the intermediate diameter 280.

[0087] Although the outer profile of the balloon 218 is shown in the example of FIG.3 with a bulbous shape as described above, it is understood that the outer profile and pleat arrangement of the balloon 218 (or any other balloon described herein) can vary and be specified to cooperate with a particular prosthetic implant for optimized crimping and expansion.

[0088] The balloon 218 (or any other balloon described herein) can be made of a polymeric material, such as for example, a polyamide (PA) or co-polyamide, such as nylon (for example nylon 12), Pebax®, Grilamid L25, a polyester, such as polyethylene terephthalate (PET), polybutylene terephthalate, a thermoplastic elastomer copolyester (such as Hytrel®), or combinations thereof.

[0089] As noted above, the balloon 218 (or any other balloon described herein) can be covered to reduce the likelihood of damage to the damage to the balloon and / or to retain the pleats 270. A balloon cover (also referred to herein as a “cover”) can further be configured to minimize the risk of pinching the balloon when the cover is assembled over the balloon. According to an example, as shown in FIG.4, a balloon cover 300 can comprise a first, proximal housing component (also referred to herein as a “first housing component” or a “first housing”) 310. The first housing 310 can have a first longitudinal axis 312, a distal end 314, a proximal end 316 disposed a distance 317 from the distal end 314, and an outer surface 318 extending between the distal and proximal ends 314, 316.

[0090] The balloon cover 300 can further comprise a second, distal housing component (also referred to herein as a “second housing component” or a “second housing”) 320, which can be coupled to the first housing 310. The second housing 320 can have a second longitudinal axis 322, a distal end 324, a proximal end 326 disposed a distance 327 from the distal end 324, and an outer surface 328 extending between the distal and proximal ends 324, 326.

[0091] In some examples, the first housing 310 can comprise a complete annular body that fully encircles the first longitudinal axis 312. That is, the complete annular body can be constructed as a single, uninterrupted unitary body extending from the distal end 314 to the proximal end 316 and around the axis 312 a full 360 degrees. In some examples, the outer surface 318 is free of any parting lines, gaps, or junctions. The first housing 310 can be machined, molded, cast, or fabricated using additive manufacturing techniques such as 3D printing, and can made from any of various suitable polymers, metals, or combinations thereof.

[0092] In some examples, the second housing 320 can comprise a complete annular body that fully encircles the second longitudinal axis 322. That is, the complete annular body canbe constructed as a single, uninterrupted unitary body extending from the distal end 324 to the proximal end 326 and around the axis 322 a full 360 degrees. In some examples, the outer surface 328 is free of any parting lines, gaps, or junctions. The second housing 320 can be machined, molded, cast, or fabricated using additive manufacturing techniques such as 3D printing, and can made from any of various suitable polymers, metals, or combinations thereof.

[0093] In some examples, a balloon cover can be adapted for use with a specific balloon. In other words, a balloon can have a corresponding cover with a length and internal cavities that are configured for use with that particular balloon and / or balloon catheter. For example, the balloon cover 300 in FIG.4 can be configured for use with the balloon 218 and balloon catheter of FIG.3.

[0094] The first housing 310 can be configured to cover at least the proximal portion 276 of the balloon 218. In some examples, the first housing 310 can also cover a section of the distal portion 274 of the balloon 218, for example, at least a portion of the bulbous shaped section shown in FIG.3. As such, the first housing 310 can have a cavity 330 extending between the distal and proximal ends 314, 316, where the cavity 330 generally corresponds to the portion of the outer profile of the balloon 218 it surrounds. That is, if the first housing 310 is adapted to surround the intermediate diameter 280 of the balloon 218 and a proximal section of the bulbous shaped distal portion 274, the cavity 330 can be defined by an inner, annular surface 331 that generally corresponds to the shape of the proximal portion 276 of the balloon, the intermediate diameter 280 and the proximal section of the distal portion 274 of the balloon 218. Thus, in the illustrated example, the cavity 330 has a maximum diameter at the distal end 314 and has a tapered section 331a that tapers from the distal end 314 to a cylindrical section 331b having a constant diameter.

[0095] The distance 317 (i.e., a length of the first housing 310 along the longitudinal axis 312) can be selected to cover and protect, not only a portion of the balloon 218, but also a portion of the balloon shaft 206 in some examples. As such, the cavity 330 can be configured to additionally accommodate an outer diameter of the balloon shaft 206.

[0096] As seen in FIG.4, the second housing 320 can be configured to cover at least a section of the distal portion 274 of the balloon 218, for example, at least a portion of the bulbous shaped section shown in FIG.3. The second housing 320 optionally can also be configured to cover the nose cone 222. As such, the second housing 320 can have a cavity 332 that generally corresponds to the portion of the outer profile of the balloon 218 it surrounds as well as the nose cone 222 or other portions of the delivery apparatus. Thedistance 327 (i.e., a length of the second housing 320 along the longitudinal axis 322) can be selected to cover and protect a portion of the balloon 218, and optionally the nose cone 222 or at least a portion thereof. Thus, in some examples, the cavity 330 can be defined by an inner, annular surface 333 that generally corresponds to the shape of the outer profile of the balloon 218 and the other portions of the delivery apparatus it surrounds.

[0097] In the illustrated example, the surface 333 has a maximum diameter at the proximal end 326 and has a tapered section 333a that tapers from the proximal end 326 to a cylindrical section 333b having a constant diameter. The cavity 332 can extend the entire length of the second housing 320 from the proximal end 326 of the second housing 320 to the distal end 324 in some examples, as seen in FIG.4. In other examples, the distal end 324 of the second housing 320 can be closed and / or capped off by a distal wall such that the cavity does not extend the entire length of the second housing 320.

[0098] The cavities 330, 332 can be configured to ensure that the pattern and orientation of the pleats 270 are preserved. That is, when the cover 300 is assembled over the balloon 218, the pleats 270 are less likely to shift or move. In some examples, the inner, annular surfaces 331, 333 can be sized such that a gap exists the outer profile of the balloon 218 and the inner, annular surfaces 331, 333 when the cover 300 is assembled around the balloon 218.

[0099] As described above, the second housing 320 can be configured to couple to the first housing 310 with the balloon 218 inside. For example, the second housing 320 can have one or more coupling features at or adjacent the proximal end 326. The first housing 310 can have one or more corresponding coupling features at or adjacent the distal end 314. As such, the second housing 320 and the first housing 310 can be configured to overlap at or adjacent their proximal and distal ends, respectively. The cavities 330, 332 can be configured to match the outer profile of the balloon 218 as described above taking any overlap into consideration.

[0100] As shown in the example of FIG.4, the second housing 320 has a first coupling feature 340. The coupling feature 340 can have an axially extending, flexible arm 342 and a radially extending projection 344 disposed at an end of the flexible arm 342, which define an annular groove 345 that opens at the proximal end of the second housing 320. In some examples, the coupling feature 340 and the groove 345 can extend around an entire circumference of the second housing 320 at the proximal end 326. In other examples, the first coupling feature 340 and the groove 345 can extend less than the entire circumference of the second housing 320, or the second housing can be formed with a plurality of coupling features 340 and grooves 345 that are circumferentially spaced from each other.

[0101] The first coupling feature 340 can be configured to interface with a second coupling feature 348 of the first housing 310. The second coupling feature 348 can be in the form of an annular groove 350 formed on the outer surface 318 of the first housing 310 and an annular projection 352 at the distal end 314. The groove 350 can be an annular recess extending radially into the first housing 310 from the outer surface 318 along an entire circumference of the outer surface 318. In some examples, the groove 350 and the projection 352 can extend less than the entire circumference of the first housing 310, or the first housing can be formed with a plurality of grooves 350 and projections 352 that are circumferentially spaced from each other around the circumference of the outer surface 318. The projection 352 can be formed with a chamfered or beveled outer surface 354.

[0102] The first and second coupling features 340, 348 can be placed in mating engagement with each other by placing the first and second housings 310, 320 in a partially overlapping configuration. By urging the first and second housings 310, 320 toward each other along longitudinal axes 312, 322, the flexible arm 342 of the first coupling feature 340 can deflect radially outward as the chamfered outer surface 354 slides against an inner surface 346 of the projection 344 until the projection 344 slides over the projection 352 and is urged into the groove 350. With the projection 344 biased into position within the groove 350, the second housing 320 is secured to the first housing 310 and axial movement therebetween is minimized. In this manner, the first and second coupling features 340, 348 can be referred to as snap-fit connecting elements that form a “snap-fit” connection between the first and second housings 310, 320.

[0103] The first housing 310 and the second housing 320 can have additional features to facilitate coupling and / or decoupling from each other. For example, the projection 344 can be formed with a chamfered surface that slides against the chamfered outer surface 354 of the projection 352. In some examples, the positions of the first and second coupling features can be reversed; that is, the first coupling feature 340 can be formed on a distal end portion of the first housing 310 and the second coupling feature 348 can be formed on the second housing 320.

[0104] In other examples, in lieu of or in addition to snap-fit connection elements, the coupling features can include interfacing threads, clips, clamps, notches, bayonet elements, and / or spring detents configured to securely and releasably couple the second housing 320 to the first housing 310. The interfacing coupling features can be configured to extend around an entire circumference of the second housing 320 and / or the first housing 310. In someexamples, the interfacing coupling features can be disposed over portions of the circumference of the second housing 320 and / or the first housing 310.

[0105] In some examples, as seen in FIG.4, an outer diameter of the second housing 320 can be greater than an outer diameter of the first housing 310, such that a portion of the second housing 320 extends partially over the outer surface 318 of the first housing 310 as described. In other examples, the outer diameter of the first housing 310 can be greater than the outer diameter of the second housing 320 such that a portion of the first housing 310 extends partially over the second housing 320, for example, if the positions of the first and second coupling features 340, 348 are reversed.

[0106] The outer surfaces 318, 328 can have various shapes and / or features. In some examples, the outer surfaces 318, 328, can have any complete, annular shape (such as, for example, cylindrical or polygonal).

[0107] In some examples, the outer surfaces 318, 328, can have features to facilitate gripping by a user, such as for example, finger grooves or texturing, annular ramps, or piece- wise steps.

[0108] To assemble the cover 300 over the balloon 218, as shown in FIG.5, a proximal end of the balloon shaft 206 can be inserted into the first housing 310 through the cavity 330 in a distal-to-proximal direction along the longitudinal axis 312, where the longitudinal axis 312 is colinear with a longitudinal axis 272 of the balloon shaft 206. The first housing 310 can be advanced over the proximal portion 276 of the balloon 218 in a proximal-to-distal direction along the longitudinal axis 312. As such, the first housing 310 can completely surround at least the proximal portion 276 of the balloon 218 and, in some examples as shown in FIGS. 4-5, can also completely surround a proximal section of the bulbous shaped distal portion 274 of the balloon.

[0109] The second housing 320 can be positioned over the distal end portion 274 of the balloon 218 and the nose cone 222. The second housing 320 can be advanced over the first housing 310 in a distal-to-proximal direction along the longitudinal axis 322, where the longitudinal axis 322 is colinear with a longitudinal axis 272 of the balloon shaft 206 and the longitudinal axis 312. The second housing 320 can be advanced over the distal end 314 of the first housing 310 along the longitudinal axis 322 until the coupling features of the first housing 310 and the second housing 320 engage, as described above. As such, the second housing 320 can completely surround at least a portion of the balloon 218.

[0110] When assembled, as shown in FIG.6, the longitudinal axis 322 of the second housing 320 is colinear with both the longitudinal axis 312 of the first housing 310 and a longitudinalaxis 272 of the balloon shaft 206. Because the second housing 320 is advanced over the distal end 314 of the first housing 310 along the longitudinal axis 322, overlapping portions of the first and second housings 310, 320 act like a funnel during coupling and likelihood of pinching of the balloon 218 is minimized.

[0111] In examples where the first housing 310 is adapted to extend over the second housing 320 during assembly, as described above, the first housing 310 can be advanced over the proximal end 326 of the second housing 320 along the longitudinal axes 312, 322 until the interfacing coupling features of the first housing 310 and the second housing 320 engage.

[0112] The second housing 320 can be decoupled from the first housing 310 to expose the balloon 218 for crimping a prosthetic device (such as a prosthetic heart valve) on the balloon. To release the housing components from each other and uncover the balloon 218, the distal end portion of the first housing 310 can be squeezed slightly while pulling the second housing 320 and the first housing 310 apart from each other in opposite directions along the longitudinal axes 312, 322, thereby disengaging the interfacing coupling features from each other.

[0113] The second housing 320 can be removed from the delivery apparatus by sliding it off the balloon and the nosecone in a distal direction. In some examples, the first housing 310 can be slid proximally over the outermost shaft of the delivery apparatus (e.g., shaft 204) to a position adjacent the handle (e.g., handle 202). In some examples, the first housing 310 can have a frangible, breakable, or removable section configured to form a longitudinal slit or slot extending the length of the first housing 310 that allows the first housing 310 to be removed from the shaft 206 prior to an implantation procedure. For example, the first housing 310 can comprise a tear tab that extends the length of the first portion which, when pulled by a user, creates a slit or slot in the side wall of the first housing extending the length of the side wall.

[0114] In this way, a balloon cover can comprise two, coupled housing components, each having complete annular bodies, where the housing components can be configured to both protect a balloon during shipment and storage, and couple together in a manner that minimizes risk of damage to the balloon within.

[0115] Although the first housing 310 is primarily described herein as having a complete annular configuration free of any parting lines, gaps, or junctions, in some examples, the first housing 310 may comprise features to facilitate insertion and removal from a delivery apparatus. That is, the first housing 310 may have features that allow the first housing 310 to be installed over or removed from a delivery apparatus. For example, the first housing 310 may comprise a longitudinal channel or slot extending the length of the first housing 310 andextending radially from the outer surface 318 to the inner surface 331. The channel or slot can be sized such that the first housing 310 can be placed on or removed from the shaft 206 in a lateral direction by passing the shaft 206 through the slot or channel. In some examples, first housing 310 can include a hinge connecting two halves or portions of the first housing and configured to allow the two halves or portions of the first housing to be moved toward and away from each other to allow the first housing to be placed on or removed from the shaft 206. Sterilization

[0116] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Delivery Techniquesa prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (e.g., by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Additionally and / or alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Additionally and / or alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-sternotomy or right parasternalmini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0118] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Additionally and / or alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0119] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advanced through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0120] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0121] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

[0122] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example. Additional Examples of the Disclosed Technology

[0123] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0124] Example 1. A balloon cover for a catheter balloon, the balloon cover comprising: a first housing component; and a second housing component, wherein a distal end portion of the first housing component is adapted to be releasably coupled to a proximal end portion of the second housing component.

[0125] Example 2. The balloon cover of any example herein, particularly example 1, wherein the first housing component has a first cavity adapted to receive a proximal portion of the catheter balloon and the second housing component has a second cavity adapted to receive a distal portion of the catheter balloon.

[0126] Example 3. The balloon cover of any example herein, particularly example 2, wherein the first cavity, the second cavity, or both the first cavity and the second cavity are adapted to receive a portion of a balloon catheter other than the balloon.

[0127] Example 4. The balloon cover of any example herein, particularly any one of examples 2-3, wherein the first cavity, the second cavity, or both the first cavity and the second cavity are adapted to receive a portion of the catheter balloon having a varying outer diameter.

[0128] Example 5. The balloon cover of any example herein, particularly any one of examples 2-4, wherein the first cavity, the second cavity, or both the first cavity and the second cavity are adapted to receive a bulbous shaped section of the catheter balloon.

[0129] Example 6. The balloon cover of any example herein, particularly any one of examples 2-5, wherein the first cavity, the second cavity, or both the first cavity and the second cavity are adapted to receive a portion of the catheter balloon having a constant outer diameter.

[0130] Example 7. The balloon cover of any example herein, particularly any one of examples 2-6, wherein the first cavity is defined by a first inner surface and the second cavity is defined by a second inner surface, wherein the first and second inner surfaces are configured to provide a gap between an outer surface of the catheter balloon and the first and second inner surfaces when the first and second housing components are coupled to each other.

[0131] Example 8. The balloon cover of any example herein, particularly any one of examples 1-7, wherein the first housing component has a first longitudinal axis and the second housing component has a second longitudinal axis, wherein the first longitudinal axis and the second longitudinal axis are colinear when the first housing component and the second housing component are coupled to each other.

[0132] Example 9. The balloon cover of any example herein, particularly example 8, wherein the first housing component and the second housing component are configured to be decoupled from each other by moving the first and second housing components in opposite directions along the first longitudinal axis and the second longitudinal axis.

[0133] Example 10. The balloon cover of any example herein, particularly any one of examples 1-9, wherein the distal end portion of the first housing component comprises a first coupling feature and the proximal end portion of the second housing component comprises a second coupling feature, wherein the first coupling feature is adapted to engage the second coupling feature to couple the first and second housing components to each other.

[0134] Example 11. The balloon cover of any example herein, particularly example 10, wherein the first and second coupling features are adapted to form a snap-fit connection.

[0135] Example 12. The balloon cover of any example herein, particularly any one of examples 10-11, wherein the first coupling feature is formed on an outer surface of the first housing component and the second coupling feature is formed on an inner surface or an end surface of the second housing component.

[0136] Example 13. The balloon cover of any example herein, particularly any one of examples 1-12, wherein the first housing component comprises a complete annular body.

[0137] Example 14. The balloon cover of any example herein, particularly any one of examples 1-13, wherein the second housing component comprises a complete annular body.

[0138] Example 15. An assembly comprising: a balloon catheter comprising a shaft and a balloon; a cover surrounding the balloon, wherein the cover comprises: a first, proximal housing component; and a second, distal housing component coupled to the first, proximal housing component, wherein the first, proximal housing component and the second, distal housing component are separable from each other to uncover the balloon by moving the first, proximal housing component and the second, distal housing component in opposite directions along a longitudinal axis of the balloon catheter.

[0139] Example 16. The assembly of any example herein, particularly example 15, wherein the balloon has a proximal portion and a distal portion, and wherein the first, proximal housing component has a first cavity having a shape that corresponds to a shape of the proximal portion of the balloon and the second, distal housing component has a second cavity having a shape that corresponds to a shape of the distal portion of the balloon.

[0140] Example 17. The assembly of any example herein, particularly example 16, wherein the first, proximal housing component completely surrounds the proximal portion of the balloon.

[0141] Example 18. The assembly of any example herein, particularly any one of examples 16-17, wherein the second, distal housing component completely surrounds the distal portion of the balloon.

[0142] Example 19. The assembly of any example herein, particularly any one of examples 16-18, wherein the first cavity, the second cavity, or both the first and second cavities have a shape that is adapted to receive a portion of the balloon catheter other than the balloon.

[0143] Example 20. A method comprising: positioning a first housing component of a cover over a proximal portion of a balloon of a balloon catheter; positioning a second housing component of the cover over a distal portion of the balloon; and coupling a proximal end portion of the second housing component to a distal end portion of the first housing component.

[0144] Example 21. The method of any example herein, particularly example 20, wherein positioning the first housing component over the proximal portion of the balloon comprises moving the first housing component in a proximal-to-distal direction along a longitudinal axis of the balloon catheter.

[0145] Example 22. The method of any example herein, particularly any one of examples 20-21, wherein positioning second housing over the distal portion of the balloon comprising moving the second housing component in a distal-to-proximal direction along a longitudinal axis of the balloon catheter.

[0146] Example 23. The method of any example herein, particularly any one of examples 20-22, wherein coupling the proximal end portion of the second housing component to the distal end portion of the first housing component comprises forming a snap-fit connection between the second housing component and the first housing component.

[0147] Example 24. The method of any example herein, particularly any one of examples 20-23, further comprising removing the second housing component from the first housing component in a direction along the longitudinal axis of the balloon catheter.

[0148] Example 25. The method of any example herein, particularly any one of examples 20-24, wherein the first housing component comprises a complete annular body.

[0149] Example 26. The method of any example herein, particularly any one of examples 20-25, wherein the second housing component comprises a complete annular body.

[0150] Example 27. A method comprising sterilizing the prosthetic heart valve, apparatus, delivery apparatus, balloon cover, and / or assembly of any example.

[0151] Example 28. A prosthetic heart valve, apparatus, delivery apparatus, balloon cover, and / or assembly of any one of examples 1-26, wherein the prosthetic heart valve, apparatus, delivery apparatus, cover, and / or assembly is sterilized.

[0152] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one or more of the features of a balloon cover can be combined with any one or more features of another balloon cover. As another example, any one or more features of one delivery apparatus can be combined with any one or more features of another delivery apparatus.

[0153] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

CLAIMS:

1. A balloon cover for a catheter balloon, the balloon cover comprising: a first housing component; and a second housing component, wherein a distal end portion of the first housing component is adapted to be releasably coupled to a proximal end portion of the second housing component.

2. The balloon cover of claim 1, wherein the first housing component has a first cavity adapted to receive a proximal portion of the catheter balloon and the second housing component has a second cavity adapted to receive a distal portion of the catheter balloon.

3. The balloon cover of claim 2, wherein the first cavity, the second cavity, or both the first cavity and the second cavity are adapted to receive a portion of a balloon catheter other than the balloon.

4. The balloon cover of any one of claims 1-3, wherein the first housing component has a first longitudinal axis and the second housing component has a second longitudinal axis, wherein the first longitudinal axis and the second longitudinal axis are colinear when the first housing component and the second housing component are coupled to each other.

5. The balloon cover of claim 4, wherein the first housing component and the second housing component are configured to be decoupled from each other by moving the first and second housing components in opposite directions along the first longitudinal axis and the second longitudinal axis.

6. The balloon cover of any one of claims 1-5, wherein the distal end portion of the first housing component comprises a first coupling feature and the proximal end portion of the second housing component comprises a second coupling feature, wherein the first coupling feature is adapted to engage the second coupling feature to couple the first and second housing components to each other.

7. The balloon cover of claim 6, wherein the first and second coupling features are adapted to form a snap-fit connection.

8. The balloon cover of any one of claims 6-7, wherein the first coupling feature is formed on an outer surface of the first housing component and the second coupling feature is formed on an inner surface or an end surface of the second housing component.

9. The balloon cover of any one of claims 1-8, wherein the first housing component comprises a complete annular body.

10. The balloon cover of any one of claims 1-9, wherein the second housing component comprises a complete annular body.

11. An assembly comprising: a balloon catheter comprising a shaft and a balloon; a cover surrounding the balloon, wherein the cover comprises: a first, proximal housing component; and a second, distal housing component coupled to the first, proximal housing component, wherein the first, proximal housing component and the second, distal housing component are separable from each other to uncover the balloon by moving the first, proximal housing component and the second, distal housing component in opposite directions along a longitudinal axis of the balloon catheter.

12. The assembly of claim 11, wherein the balloon has a proximal portion and a distal portion, and wherein the first, proximal housing component has a first cavity having a shape that corresponds to a shape of the proximal portion of the balloon and the second, distal housing component has a second cavity having a shape that corresponds to a shape of the distal portion of the balloon.

13. The assembly of claim 12, wherein the first, proximal housing component completely surrounds the proximal portion of the balloon.

14. The assembly of any one of claims 12-13, wherein the second, distal housing component completely surrounds the distal portion of the balloon.

15. A method comprising:positioning a first housing component of a cover over a proximal portion of a balloon of a balloon catheter; positioning a second housing component of the cover over a distal portion of the balloon; and coupling a proximal end portion of the second housing component to a distal end portion of the first housing component.

16. The method of claim 15, wherein positioning the first housing component over the proximal portion of the balloon comprises moving the first housing component in a proximal-to-distal direction along a longitudinal axis of the balloon catheter.

17. The method of any one of claims 15-16, wherein positioning the second housing component over the distal portion of the balloon comprises moving the second housing component in a distal-to-proximal direction along the longitudinal axis of the balloon catheter.

18. The method of any one of claims 15-17, further comprising removing the second housing component from the first housing component in a direction along the longitudinal axis of the balloon catheter.

19. The method of any one of claims 15-18, wherein the first housing component comprises a complete annular body.

20. The method of any one of claims 15-19, wherein the second housing component comprises a complete annular body.

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