Patent Description:
Prosthetic heart valves are manufactured and prepared for insertion into patients during a surgical procedure. The valves must be sterilized after manufacture and stored in a container for shipment to a hospital or surgery center. The valve is then removed from its packaging, rinsed, and prepared for placement in a patient during surgery.

A viable container for a packaged prosthetic heart valve should preserve the sterile condition of the valve and protect the valve from damage during shipment. Sterilization is critical and challenging in working with prosthetic devices. With some prosthetic heart valve packaging approaches, the valve is submerged in a sterilization solution (sometimes referred to as "wet" storage), such as a <NUM>% glutaraldehyde solution. Glass jars or translucent resin jars are commonly used as the container for such packaging schemes (i.e., where the prosthetic heart valve is to remain submerged in a sterilization solution during shipment and storage) because the selected material resists reacting with the solution, is generally inexpensive, and can withstand sterilization. Conventionally, the jar container is covered and sealed with a threaded lid and silicone seal. It can at times be somewhat difficult for an end user to remove the so-assembled lid.

<CIT> describes assemblies and methods for sterilizing a wet stored prosthetic heart valve.

<CIT> describes a moisture resistant package for storing sterile items.

<CIT> relates to a dry prosthetic heart valve packaging system.

<CIT> describes a storage container that can be used to store medicines, vaccines, blood, organs, etc..

<CIT> describes processes and systems for loading medical implants with stimulative growth agents.

<CIT> describes a method for treating a prosthesis having an apertured structure and associated devices.

<CIT> describes a self-adapting isothermal container.

Moreover, additional or secondary packaging materials and the like are often employed when shipping glass (or similar material) container-packaged prosthetic heart valves, endeavoring to provide robust protection against thermal and physical damage. For example, the primary packaging (i.e., jar with threaded lid containing a prosthetic heart valve and sterilization solution) can be placed within a formed cushioning structure (e.g., foam) and loaded into a paperboard carton to provide a packaged unit. Additional thermal and physical protection is typically utilized when shipping the packaged unit. For example, multiple packaged units are typically placed into an insulated shipping container (e.g., outer cardboard box with foam panels or foil lining for thermal insulation, and one or more refrigerant-type items (e.g., refrigerant phase change gel packs) for cooling) when shipped from the manufacturer to a distribution center. These and other steps can be important to ensure that the prosthetic heart valve stays within a specific temperature range. A protective insulated shipping container may not be available for delivery of a packaged unit from the distribution center to an end user.

The inventors of the present disclosure recognized that a need exists for improved packaging systems and methods for storage and/or shipment prosthetic heart valves and similar products. The invention relates to a packaging system as defined in independent claim <NUM>.

According to the invention, the packaging systems for storing a prosthetic heart valve in a sterilization solution include a cup and a lid. The cup is sized and shaped to contain the prosthetic heart valve and a volume of sterilization solution sufficient, for example, for submerging the prosthetic heart valve. The lid is configured for a securement to the cup in a manner that does not include or entail a threaded connection. For example, the lid can be a thin foil or film that is sealed (e.g., heat sealed) to the cup. With these non-limiting embodiments, the lid can be removed from the cup for accessing the prosthetic heart valve by peeling the lid away from the cup. In other examples, the cup and the lid can be akin to a conventional consumable product can (e.g., soup can) in which a metal lid can be pulled away from the cup along a score line. In yet other embodiments, the prosthetic heart valve and sterilization solution are held by a protective frame and contained within a flexible pouch with an easy opening, sealed end. Regardless, the packaging systems of the present disclosure can overcome concerns associated with convention packaging, such as the sterilization solution crystallizing between a threaded interface between glass jar and lid.

In some embodiments, the packaging systems can further include a vacuum flask and corresponding cap. For example, the prosthetic heart valve and sterilization solution can be sealed and contained within the cup and lid to provide a wet packaged prosthetic heart valve that in turn can be placed within the vacuum flask and covered by the cap. The vacuum flask and cap combine to provide thermal and physical protection for the wet packaged prosthetic heart valve, and is well suited for expected shipping and storage conditions. In related embodiments, a temperature indicator device can be provided with the flask and cap, and include a temperature sensor located in close proximity to the wet packaged prosthetic heart valve (e.g., the temperature sensor is located on the lid and thus inside of the vacuum flask/cap). With these and related embodiments, the temperature indicator device provides a meaningful representation of temperature conditions directly experienced by the prosthetic heart valve/sterilization solution. In yet other embodiments, the temperature indicator device include a display component that is visible from an exterior of the cap, providing a viewer with information indicative of the prosthetic heart valve temperature conditions while stored (and shipped) within the flask.

Aspects of the disclosure are directed to packaging systems for storage of a prosthetic heart valve in a sterilization solution, and resultant wet packaged prosthetic heart valves. In some embodiments, the packaging systems of the present disclosure promote consistent, easy opening by an end user for accessing the stored prosthetic heart valve. In some embodiments, the packaging systems of the present disclosure can provide one or more additional features, for example thermal and physical protection appropriate for shipping, storing, and validation of the packaged prosthetic heart valve. In some embodiments, the packaging systems of the present disclosure are useful with and can accommodate different sizes and/or styles of prosthetic heart valves, affording a manufacturer the ability to employ a single packaging scheme with multiple different products. The packaging systems and methods of the present disclosure can be useful with items other than prosthetic heart valves, for example other medical device products benefiting from storage in a liquid solution. Further, the packaging systems and methods of the present disclosure can be useful for the storage and/or shipping of dry products, such as a "dry" stored prosthetic heart valve; thus, in alternative embodiments, the packaging systems can disclosed below can be utilized without a sterilization solution or other liquid.

As a point of reference, the packaging systems and methods of the present disclosure are useful with a plethora of differently-configured prosthetic heart valves. For example, the packaging systems and methods of the present disclosure can be useful with a prosthetic heart valve designed or configured to replace an aortic valve, a mitral valve, a tricuspid valve, or a pulmonic valve. Similarly, the packaging systems and methods of the present disclosure can be useful with a prosthetic heart valve designed or configured for transcatheter implantation or open-heart surgical implantation. Thus, to the extent the drawings might implicate a particular prosthetic heart valve design, the present disclosure is in no way limited. The prosthetic heart valves envisioned by the present disclosure more generally entail a structure (e.g., a stent or frame) supporting one or more leaflets (e.g., tissue or synthetic).

One embodiment of a packaging system <NUM> for storage of a prosthetic heart valve <NUM> in accordance with principles of the present disclosure is shown in <FIG>. The packaging system <NUM> includes a cup <NUM>, a lid <NUM>, a vacuum flask <NUM>, a cap <NUM>, and an optional temperature indicator device <NUM>. Details on the various components are provided below. In general terms, however, the cup <NUM> and lid <NUM> combine to serve as primary packaging, containing the prosthetic heart valve <NUM> and a sterilization solution (not shown), such as a glutaraldehyde solution, in a sealed environment. A wet packaged prosthetic heart valve <NUM> (referenced generally) is defined as the prosthetic heart valve <NUM> and sterilization solution sealed within the cup <NUM> and the lid <NUM> (e.g., a "wet packaged prosthetic heart valve" can be in reference to a prosthetic heart valve and sterilization solution secured within primary packaging, and the prosthetic heart valve is immediately or directly accessible upon opening the primary packaging). The vacuum flask <NUM> is configured to receive the wet packaged prosthetic heart valve <NUM>, with the flask <NUM> and the cap <NUM> combining to provide secondary or outer packaging <NUM> (best identified in <FIG>). Upon assembly of the cap <NUM> to the flask <NUM>, the outer packaging <NUM> provides robust thermal and physical protection for the wet packaged prosthetic heart valve <NUM>, and in particular the prosthetic heart valve <NUM>. With additional reference to <FIG>, a prosthetic heart valve packaged unit <NUM> is defined as the wet packaged heart valve <NUM> contained within the outer packaging <NUM> (e.g., a "prosthetic heart valve packaged unit" can be in reference to a wet packaged prosthetic heart valve secured within an outer container, and the prosthetic heart valve is not immediately or directly accessible upon opening the outer container).

The prosthetic heart valve packaged unit <NUM> is well suited for all stages of shipment from a manufacturer to an end user. Optionally, the prosthetic heart valve packaged unit <NUM> can be placed in a labeled outer carton prior to shipment; in some embodiments, however, no additional or secondary thermal insulation packaging is required. To access the wet packaged prosthetic heart valve <NUM>, the cap <NUM> is readily removable from the flask <NUM>. To then access the prosthetic heart valve <NUM>, the lid <NUM> is easily removed from the cup <NUM>. The optional temperature indicator device <NUM> can be contained within the outer packaging <NUM>, sensing temperature conditions experienced by the wet packaged prosthetic heart valve <NUM>, and thus by the prosthetic heart valve <NUM>, while maintained within the outer packaging <NUM>. An end user can thus quickly and confidently verify implantability of the prosthetic heart valve <NUM>.

The cup <NUM> can assume various forms appropriate for containing the prosthetic heart valve <NUM> and a volume of sterilizing solution (or other liquid), as well as facilitating assembly of the lid <NUM>. For example, with the non-limiting example of <FIG>, the cup <NUM> includes or defines a cup body <NUM> and a rim <NUM>. The cup body <NUM> extends from a closed end <NUM> (referenced generally) to the rim <NUM>. An interior region <NUM> of the cup body <NUM> is open at the rim <NUM>, and is sized and shaped to receive an entirety of the prosthetic heart valve <NUM> in a configuration intended by the manufacturer for storage prior to implant. In some embodiments, the interior region <NUM> is sized and shaped to accommodate different sizes of a particular style of prosthetic heart valve (e.g., some manufacturers provide a particularly-designed prosthetic heart valve in two or more sized). For example, <FIG> illustrate another cup 40a useful with the packaging system <NUM> (<FIG>) and accommodating different sizes of the same style prosthetic heart valve 30a-30d (e.g., the prosthetic heart valves 30a-30d are the same design/style, but progressively smaller from <FIG>). Regardless, and returning to <FIG>, the interior region <NUM> can be sized and shaped to be slightly larger than a size/shape of the largest prosthetic heart valve intended to be packaged. For example, where the prosthetic heart valve <NUM> is generally cylindrical in shape, a geometry of the interior region <NUM> can be akin to a right cylinder, having a diameter approximating a diameter of the prosthetic heart valve <NUM> and a height slightly larger than a height of the prosthetic heart valve <NUM>. These and other attributes can serve to minimize an overall footprint of the cup body <NUM> and a volume of the sterilization solution required to submerge the prosthetic heart valve <NUM> as compared to some conventional designs in which the prosthetic heart valve is stored/shipped in a standard-sized glass jar that is typically much larger than the prosthetic heart valve <NUM>. Other features can optionally be incorporated into the cup body <NUM> to further reduce the requisite volume of sterilization solution. For example, and as shown for the cup 40a in <FIG>, an inward protrusion <NUM> can be defined at the closed end <NUM> that reduces a volume of the interior region <NUM>.

Returning to <FIG>, the cup <NUM> can be formed from a variety of materials compatible with both the prosthetic heart valve <NUM> and the solution (e.g., sterilization solution) to be contained in the cup <NUM>. For example, where the solution is a glutaraldehyde solution, the material selected for the cup <NUM> will not degrade in the presence of the glutaraldehyde solution. Further, the material of the cup <NUM> is desirably selected to establish a sterile barrier for the interior region <NUM>. In some embodiments, at least the cup body <NUM> is formed to be transparent or substantially transparent (i.e., with <NUM>% of truly transparent) to permit viewing of the prosthetic heart valve <NUM> when disposed in the interior region <NUM>. For example, in some non-limiting embodiments, the cup <NUM> is a thermoformed plastic structure formed of a transparent or substantially transparent resin such as clear polypropylene, a copolyester material available from Eastman Chemical Co. under the tradename Tritan™, etc. Other materials and/or manufacturing techniques (e.g., blow molding, injection molding, etc.) are also acceptable.

The rim <NUM> is sized and shaped to promote attachment of the lid <NUM>. For example, where the lid <NUM> is to be heat sealed to the rim <NUM>, the rim <NUM> can form or define a relatively flat receiving surface. The rim <NUM> can be integrally formed with the cup body <NUM>, or can be separately formed and subsequently attached. In some embodiments, where the cup body <NUM> has a cylindrical shape, the rim <NUM> can be formed to have a ring or ring-like shape. Other configurations are also acceptable. For example, while the rim <NUM> is shown in <FIG> as being a ring, one or more additional features can be provided. For example, with the cup 40a as shown in <FIG>, a rim 82a is provided and includes a rim body <NUM> and one or more tabs <NUM>. The rim body <NUM> provides a surface for receiving the lid <NUM> (<FIG>). The tab(s) <NUM> extend radially outward from the rim body <NUM>. A fold line <NUM> is formed and about which the corresponding tab <NUM> can pivot relative to the rim body <NUM>. With this construction, the tab(s) <NUM> can be folded upwardly relative to the rim body <NUM> during insertion into the vacuum flask <NUM> (<FIG>), providing a convenient surface for grasping by a user to remove the cup 40a from the vacuum flask <NUM> as described in greater detail below.

Returning to <FIG>, the lid <NUM> is sized and shaped in accordance with cup <NUM>, and in particular the rim <NUM>, for assembly thereto. In some embodiments, the lid <NUM> can be a thin film or foil-type body, formed of a material conducive to sealing to the rim <NUM>, that can provide a hermetically sealed, sterile barrier to the interior region <NUM>, and that is compatible with the solution (e.g., sterilization solution) to be contained in the cup <NUM>. For example, where the solution is a glutaraldehyde solution, the material selected for the lid <NUM> will not degrade in the presence of the glutaraldehyde solution. For example, the lid <NUM> can be a film or foil that is sealed or otherwise attached to the rim <NUM> by conventional heat sealing techniques, such as materials and seal manufacturing approaches used with single serving coffee creamer packaging, single serving yogurt packaging, etc. In some embodiments, the lid <NUM> can provide or include one or more features that facilitate removal from the cup <NUM> by a user. For example, the lid <NUM> can form or provide a lid body <NUM> and a pull tab <NUM>. The lid body <NUM> is sized and shaped in accordance with a size and shape of the rim <NUM>. The pull tab <NUM> extends from the lid body <NUM> and provides a convenient surface for grasping by a user when removing the lid <NUM> from the cup <NUM>.

Upon final assembly, the cup <NUM> and the lid <NUM> provide a secure, long term, sterile barrier for the contained prosthetic heart valve <NUM> and the sterilization solution. When a user desires to access the prosthetic heart valve <NUM>, the lid <NUM> is readily removed from the cup <NUM>, for example by pulling on the pull tab <NUM> to peel the lid <NUM> off of the rim <NUM>. In this regard, removal of a heat sealed, foil or film from a thermoformed container (such as the cup <NUM>) is well understood by most users. Moreover, the heat sealed format of the lid <NUM> to the rim <NUM> is not susceptible to ingress or deterioration by most, if not all, sterilization or other solutions contained with the prosthetic heart valve <NUM>. Thus, for example, a glutaraldehyde solution will not impede or otherwise negatively affect ease of removal, in contrast to conventional glass jar/threaded lid wet prosthetic heart valve packaging (in which the glutaraldehyde solution my sometimes seep in between the threads and crystalize to essentially bond the threaded lid to the jar).

The vacuum flask <NUM> can assume various forms for receiving the wet packaged prosthetic heart valve <NUM>. For example, the vacuum flask <NUM> can be a metal-walled (e.g., stainless steel or the like) vacuum-insulated flask. In general terms, vacuum-insulated flasks are known in the art, and are an insulated storage vessel consisting of two flasks, placed on within the other and joined at the neck. The space between the two flasks is at least partially evacuated, and the resulting near-vacuum substantially prevents heat transfer to or from the contents of the flask by either conduction or convection. The contents of a vacuum flask may thus remain either hotter or colder than the flask's surrounding environment for an extended period of time.

With this general construction in mind, the vacuum flask <NUM> forms or defines an external wall <NUM>, an internal wall <NUM>, and a neck <NUM>. With additional reference to <FIG>, the external wall <NUM> can have a generally cylindrical shape in extension from a bottom <NUM> to the neck <NUM>. The internal wall <NUM> defines a receptacle zone <NUM> that is sized and shaped to receive the wet packaged prosthetic heart valve <NUM>, with the receptacle zone <NUM> be open to or accessible at the neck <NUM>. For example, in some embodiments, the internal wall <NUM> can be formed to define a leading region <NUM> and a trailing region <NUM>. The leading region <NUM> extends from the neck <NUM> and has a generally cylindrical shape and/or uniform diameter. The trailing region <NUM> extends from the leading region <NUM> to a base <NUM>, and forms the receptacle zone <NUM> to have a generally tapering diameter. Other shapes or geometries are also acceptable. As best shown in <FIG>, a diameter of the base <NUM> generally corresponds with a diameter of the closed end <NUM> of the cup 40a; with these and similar constructions, the cup 40a nests against the internal wall <NUM> at or near the base <NUM> to limit overt, side-to-side movement of the wet packaged prosthetic heart valve <NUM> upon placement into the receptacle zone <NUM>. A diameter of the receptacle zone <NUM> at the leading region <NUM> generally corresponds with (e.g., is slightly larger than) a diameter or other major outer dimension of the cup 40a in a region of the rim 82a. For example, and as further reflected by <FIG>, a diameter of the leading region <NUM> is slightly larger than an outer dimeter of the rim 82a (with the optional tabs <NUM> having been folded inwardly). With these and similar embodiments, the tabs <NUM> exhibit a natural, outward bias, and will pivot toward and bear against the internal wall, thereby further stabilizing the wet packaged prosthetic heart valve <NUM> within the receptacle zone <NUM>. Other bodies or mechanism can optionally be provided that can stabilize the wet packaged prosthetic heart valve <NUM> within the receptacle zone <NUM>. Regardless, a height of the receptacle zone <NUM> is selected to be at least slightly greater than a height of the wet packaged prosthetic heart valve <NUM>.

Returning to <FIG>, the cap <NUM> can assume various forms suited for releasable assembly to the vacuum flask <NUM>, and can exhibit thermal insulative properties. For example, in some embodiments, the cap <NUM> is formed of a thermally insulating material, such as polyurethane foam or similar material. Other materials are also acceptable. The cap <NUM> (and the vacuum flask <NUM>) can be configured for assembly in a wide variety of manners. With the non-limiting example of <FIG> in which the cap <NUM> is formed of a foam or foam-like material, a shoulder <NUM> of the cap <NUM> can have an inner diameter approximating (e.g., slightly smaller than) a diameter of the external wall <NUM> of the vacuum flask <NUM>, allowing the cap <NUM> to be robustly connected to the vacuum flask <NUM> by a simple compression or friction-type fit.

The cap <NUM> can optionally include one or more additional features, for example that promote an interface with the optional temperature indicator device <NUM>. For example, the cap <NUM> can include or define a viewing port <NUM> and/or indicia relating to temperature as described in greater detail below.

Where provided, the optional temperature indicator device <NUM> can take various forms that sense temperature and generate a display relating to temperature. For example, the temperature indicator device <NUM> can include a thermal sensor/indicator (hidden in <FIG>, but identified, for example, in <FIG> at <NUM>), such as a chemical temperature sensor/indicator label or sticker as is known in the art. In general terms, the thermal sensor/indicator <NUM> is configured to change colors when exposed to a temperature outside of a predetermined window (e.g., a "go or no go" type temperature indicating label). In some embodiments, the thermal sensor/indicator <NUM> is located directly on the wet packaged prosthetic heart valve <NUM>. For example, in some non-limiting examples, the thermal sensor/indicator <NUM> is applied or placed onto the lid <NUM>, or in highly close proximity to the lid <NUM> (e.g., the thermal sensor/indicator <NUM> can be carried by a thin sheet that in turn is placed on the lid <NUM>). With these and related embodiments, the thermal sensor/indicator <NUM> will more closely sense temperatures being experienced by the wet packaged prosthetic heart valve <NUM>, and thus by the prosthetic heart valve <NUM>. This feature beneficially provides a more accurate indication of the prosthetic heart valve's suitability for implantation (e.g., the prosthetic heart valve <NUM> has or has not been exposed to thermal conditions outside of the predetermined window during shipping). In contrast, conventional prosthetic heart valve packaging for shipment techniques typically locates a temperature monitoring device away from the primary packaging (e.g., separated from the jar by packaging foam/air); under these circumstances, areas away from the prosthetic heart valve can experience thermal conditions causing the temperature monitoring device to trigger a warning while the prosthetic heart valve itself has not been subjected to those same thermal conditions. Thus, by locating the thermal sensor/indicator <NUM> at or on the wet packaged prosthetic heart valve <NUM>, the thermal sensor/indicator <NUM> measures the temperature of the liquid surrounding the prosthetic heart valve <NUM>, providing a more accurate indication of suitability of implantation and reducing instances of incorrectly rejected product.

In some embodiments in which the thermal sensor/indicator <NUM> (<FIG>) is or includes a temperature indicating label or the like and is located on or in close proximity to the lid <NUM>, the temperature indicator device <NUM> can include one or more additional components for conveying thermal-related information to a user. For example, a light pipe or light guide <NUM> can be provided. The light pipe <NUM> can be of a type known to one of ordinary skill, arranged to receive and transfer light generated by the thermal sensor/indicator <NUM>. For example, where the thermal sensor/indicator <NUM> is formatted to generate or emit visible light at predetermined wavelengths/colors that correspond with predetermined temperature conditions, a receiving end (hidden in <FIG>) of the light pipe <NUM> is arranged in close proximity to the source of the so-emitted light at the thermal sensor/indicator <NUM>. An emitting end <NUM> of the light pipe <NUM> is arranged to display the transferred light, for example to a user viewing the prosthetic heart valve packaged unit <NUM> (<FIG>). In some non-limiting examples, the emitting end <NUM> of the light pipe <NUM> is disposed in the viewing port <NUM> of the cap <NUM> and is thus visible external the cap <NUM>. In other words, the thermal sensor/indicator <NUM> can be located within the vacuum flask <NUM>/cap <NUM>, and the light (or other thermal indication) generated by the thermal sensor/indicator <NUM> can be viewed by a user without first removing the cap <NUM>. In this regard, the cap <NUM> can optionally include or provide indicia that better explains to a viewer a meaning of the displayed color. One non-limiting example of possible indicia <NUM> formed on the cap <NUM> as shown in <FIG>, along with the emitting end <NUM> of the light pipe <NUM> (<FIG>). As shown, the indicia <NUM> can convey to a viewer a meaning of the color or light at the emitting end <NUM> (e.g., conveying to a user whether the displayed color indicates that thermal conditions experienced by the prosthetic heart valve <NUM> (<FIG>) are or are not within an acceptable range).

Returning to <FIG>, the temperature indicator device <NUM> can assume other forms or formats that promote sensing and displaying of thermal conditions or information that may or may not include the light pipe <NUM>. In some non-limiting embodiments, the temperature indicator device <NUM> can alternatively include a digital-type temperature sensing and logging unit <NUM>. The temperature sensing and logging unit <NUM> can be of a type known in the art, and is generally configured to sense and record temperature over time (e.g., a lifespan on the order of seven years). The sensing and logging unit <NUM> can include a temperature sensor (hidden) and is arranged such that upon final assembly, the temperature sensor is located in close proximity to the wet packaged prosthetic heart valve <NUM> for the reasons described above. The temperature sensing and logging unit <NUM> can further be programmed to emit a predetermined color of light (e.g., via an LED carried by the temperature sensing and logging unit <NUM>) corresponding with a predetermined temperature window. For example, the temperature sensing and logging unit <NUM> can be programmed to emit a first color of light (e.g., green) when the sensed temperature is within a predetermined window, and emit a second color of light (e.g., red) when the sensed temperature is outside of the predetermined window; further programming can include the temperature sensing and logging unit <NUM> maintaining to the second color of light once "out of window" temperature conditions have been sensed, regardless of sensed future conditions (e.g., the temperature sensing and logging unit <NUM> will continually emit the second color/red even if it is later determined that the sensed temperature is subsequently within the predetermined window). With these and similar embodiments, a recorded history of thermal events associated with the wet packaged prosthetic heart valve <NUM> is available for review (e.g., by the valve manufacturer in the event the wet packaged prosthetic heart valve <NUM> is returned).

During use, the wet packaged prosthetic heart valve <NUM> is prepared by the valve manufacturer by disposing the prosthetic heart valve <NUM> and sterilization solution in the cup <NUM>, followed by hermetically sealing the lid <NUM> over the cup <NUM>. The wet packaged prosthetic heart valve <NUM> is then placed within the vacuum flask <NUM>. Where provided, the temperature indicator device <NUM> can be placed onto the wet packaged prosthetic heart valve <NUM> as shown, for example, in <FIG>. The cap <NUM> is then assembled to the vacuum flask <NUM>, resulting in the prosthetic heart valve packaged unit <NUM> of <FIG>. In some embodiments, and as shown in <FIG>, a bottom <NUM> can be provided and assembled to the vacuum flask <NUM> opposite the cap <NUM>. The bottom <NUM> can be formed of an insulative material similar to the cap <NUM>, and can have similar dimensions (e.g., outer diameter) to provide the prosthetic heart valve packaged unit <NUM> with a more uniform footprint or shape at both ends thereof.

Returning to <FIG> and <FIG>, the prosthetic heart valve packaged unit <NUM> can optionally then be packaged or placed in a paperboard box, carton, etc., along with, for example, documentation, labels and instructions for use. Under these and similar packaging options, the paperboard box can include a viewing window through with the thermal display of the prosthetic heart valve packaged unit <NUM> is visible. The prosthetic heart valve packaged unit <NUM> can then be shipped to a distribution center and/or end user in any desired fashion. The vacuum flask <NUM> and the cap <NUM> provide constant protection against physical damage and temperature extremes; no additional, secondary insulated packaging is required. Returning to <FIG>, upon receipt, the end user can immediately and accurately verify whether or not the prosthetic heart valve <NUM> has been exposed to temperature conditions outside of predetermined limits prior to removing the cap <NUM> via the temperature indicator device <NUM> in some embodiments. Where the user validates acceptable temperature conditions, the prosthetic heart valve <NUM> is easily removed from the cup <NUM> by simply peeling back the lid <NUM>.

In some situations, an end user may decide to return the wet packaged prosthetic heart valve <NUM> (e.g., when apprised of possible temperature-related concerns). Under these and similar circumstances, the end user can simply re-secure the wet packaged prosthetic heart valve <NUM> within the vacuum flask <NUM> and the cap <NUM> for shipping back to the manufacturer. Unlike conventional prosthetic heart valve packaging techniques in which an end user does not have insulative packaging available for return shipping a delivered wet packaged prosthetic heart valve, the vacuum flask <NUM>/cap <NUM> will provide requisite thermal and physical protection to the wet packaged prosthetic heart valve <NUM> throughout the return shipping process, affording the manufacturer the ability to confidently consider re-use of the wet packaged prosthetic heart valve <NUM> in the event of an incorrect end user rejection decision.

In yet other embodiments, a cover can be applied to the wet packaged prosthetic heart valve <NUM>, akin, for example, to the cap described below with respect to the embodiment of <FIG>. The cover can be configured for snap fit attachment to the cup <NUM> or other component, serving to protect the lid <NUM>. Presence of the cover or similar component can eliminate the need for secondary packaging (e.g., a shelf carton), with labels and other identifying information being applied, for example, directly onto the cup <NUM>, the lid <NUM>, and/or the cover.

Another embodiment of a packaging system <NUM> for storage of the prosthetic heart valve <NUM> in accordance with principles of the present disclosure is shown in <FIG>. The packaging system includes a cup or container <NUM>, a lid <NUM>, and an optional cap <NUM>. The cup <NUM> is sized and shaped to receive the prosthetic heart valve <NUM> and a volume of sterilization solution (not shown) sufficient to maintain the prosthetic heart valve <NUM> within the cup <NUM> (e.g., glutaraldehyde solution). The cup <NUM> can be formed of a material that is compatible with the prosthetic heart valve <NUM> and the sterilization solution, and in some embodiments can be transparent or substantially transparent (e.g., glass, polymer resin, etc.). A rim <NUM> is formed at an open end of the cup <NUM>. The lid <NUM> is a flexible sheet or membrane formed of a material providing a sterile barrier for the prosthetic heart valve <NUM> and the sterilization solution (e.g., the lid <NUM> is configured to serve as a moisture and oxygen barrier). Further, a material of the lid <NUM> is selected to be appropriate for sealed attachment to the rim <NUM> using conventional sealing techniques. For example, the lid <NUM> can be a flexible foil, a flexible foil-like material, or plastic film, such as a type commonly used with packaging of various consumable products such as dairy products, yogurt, medicine tablets, etc. In some embodiments, the lid <NUM> can form a tab <NUM> or similar structure that facilitated removal from the cup <NUM> by an end user.

Sealed attachment of the lid <NUM> to the cup <NUM> is shown in <FIG>. The state of <FIG> (in which the prosthetic heart valve <NUM> (<FIG>) and the sterilization solution (hidden) are located within the cup <NUM>) can be considered a wet packaged prosthetic heart valve <NUM>. To access the prosthetic heart valve <NUM>, a user peels back the lid <NUM> by hand (e.g., while grasping the tab <NUM>), breaking the seal between the lid <NUM> and the rim <NUM>. Once at least partially removed/peeled away from the rim <NUM>, the lid <NUM> cannot be resealed to the cup <NUM> by the end user, thus providing tamper evidence. Moreover, the sealed format of the lid <NUM> to the rim <NUM> is not susceptible to ingress or deterioration by most, if not all, sterilization or other solutions contained with the prosthetic heart valve <NUM>. Thus, for example, a glutaraldehyde solution will not impede or otherwise negatively affect ease of removal of the lid <NUM>, in contrast to conventional glass jar/threaded lid wet prosthetic heart valve packaging (in which the glutaraldehyde solution may sometimes seep in between the threads and crystalize to essentially bond the threaded lid to the jar).

Returning to <FIG>, the optional cap <NUM> can provide additional protection for the wet packaged prosthetic heart valve <NUM>, for example protecting the lid <NUM> from potential damage. The cap <NUM> can be formed from various materials that may or may not provide thermal insulation (e.g., the cap <NUM> can be silicon). Further, the cap <NUM> can be configured for assembly to the wet packaged prosthetic heart valve <NUM> (<FIG>) in various manners (e.g., the cap <NUM> can be press fitted onto the cup <NUM>, can be threaded to the cup <NUM>, etc.). In some embodiments, the cap <NUM> can include or form a port <NUM>. The port <NUM> can, for example, be sized and located to facilitate removal of liquid from the wet packaged prosthetic valve <NUM> via a syringe (not shown). Thus, the location of the port <NUM> can vary depending upon the orientation of the prosthetic heart valve <NUM> and its leaflets within the cup <NUM>.

One example of the cap <NUM> assembled to the wet packaged prosthetic heart valve <NUM> is shown in <FIG>. The cap <NUM> has been pressed fitted over, and in to engagement with, the rim <NUM>, thereby covering the lid <NUM>. In some embodiments, however, the cap <NUM> is unnecessary for establishing a complete, hermetically sealed environment between the lid <NUM> and the cup <NUM>. As described above, the port <NUM> is located and arranged to facilitate access to the lid <NUM> by a syringe (not shown); with these and related embodiments, a user can drain liquid from the wet packaged prosthetic heart valve <NUM> without first disassembling the cap <NUM>.

By sizing the cup <NUM> to more closes match a shape and size of the prosthetic heart valve <NUM>, the packaging system <NUM> of <FIG> allows for reduced material, transportation and sterilization costs as compared to conventional wet packaged prosthetic heart valve designs. It reduces the amount of sterilization solution required to maintain the prosthetic heart valve <NUM> in a wet environment, thus improving end user experiences and reducing the environmental impact as compared to conventional designs. Further, the use of the flexible, peelable lid <NUM> eliminates issues with opening a conventional glass jar/threaded lid package. In some embodiments, the wet packaged prosthetic heart valve <NUM>, with or without the cap <NUM>, can be shipped in conventional secondary packaging and/or delivered within the vacuum flask <NUM> (<FIG>) and cap <NUM> (<FIG>) as described above.

Another embodiment of a packaging system <NUM> for storage and/or shipping of the prosthetic heart valve <NUM> maintained within a sterilization solution <NUM> (e.g., glutaraldehyde) in accordance with principles of the present disclosure is shown in <FIG> and <FIG>. The packaging system <NUM> includes a frame <NUM> and a pouch <NUM>. The frame <NUM> is configured to provide structural stability for the prosthetic heart valve <NUM>, surrounding and protecting the prosthetic heart valve <NUM> from physical damage. The frame <NUM> is porous to readily permit ingress of the sterilization solution <NUM> into an interior of the frame <NUM>, thus interacting with (including submerging) the prosthetic heart valve <NUM>. Thus, for example, the frame <NUM> can be a wire mesh, a skeleton-type body, a porous material, etc. Regardless, the frame <NUM> is formed of a material that is compatible with the prosthetic heart valve <NUM> and the sterilization solution <NUM> (e.g., plastic). In some embodiments, the frame <NUM> can include or be provided with a handle <NUM> for convenient grasping by a user to remove the frame <NUM> (and thus the prosthetic heart valve <NUM> as carried by the frame <NUM>) from the pouch <NUM>. In some embodiments, and for reasons made clear below, the handle <NUM> can be foldable.

The pouch <NUM> is formed of a flexible material (e.g., foil or plastic film) that provides a sterile environment (e.g., a material of the pouch <NUM> is selected to be impervious to liquid and oxygen). The pouch <NUM> is sized and shaped in accordance with the frame <NUM>, and thus the prosthetic heart valve <NUM>. For example, the pouch <NUM> can be formed to provide or define a containment portion <NUM> and a leading portion <NUM>. The containment portion <NUM> is sized and shaped to receive the prosthetic heart valve <NUM> (as carried within the frame <NUM>) along with a sufficient volume of the sterilization solution <NUM> (e.g., the contained volume of the sterilization solution <NUM> is sufficient to fully submerge the prosthetic heart valve <NUM>). The leading portion <NUM> extends from the containment portion <NUM>, tapering in at least one outer dimension to an end region <NUM>. Walls of the pouch <NUM> are sealed to one another at the end region <NUM>, thereby forming a sterile, sealed environment for the contained prosthetic heart valve <NUM>/sterilization solution <NUM>. In some embodiments, features can be provided or formed that facilitate opening of the pouch <NUM> by a user. Notches, nicks or the like <NUM> can be partially formed through a thickness of a wall of the pouch <NUM> appropriate for tear initiation by a user as will be understood by one of ordinary skill, for example along the leading portion <NUM> at a location vertically above (relative to the orientation of <FIG> and <FIG>) an expected fill line of the sterilization solution <NUM>. With this but one acceptable configuration, a user can tear the pouch at the tear lines <NUM> to access the frame <NUM> (and thus the prosthetic heart valve <NUM> carried by the frame <NUM>) without spilling the sterilization solution.

The packaging system <NUM> combines with the prosthetic heart valve <NUM> and the sterilization solution to provide or define a wet packaged prosthetic heart valve <NUM>. The wet packaged prosthetic heart valve <NUM> can be delivered or shipped to an end user in various manners. In some non-limiting examples, the leading portion <NUM> can be folded (thus folding the handle <NUM>) onto itself, and then the wet packaged prosthetic heart valve can be wrapped in insulation to protect from extreme temperatures and placed in a carton for shipping. As compared to conventional wet packaged prosthetic heart valve designs, the packaging system <NUM> uses less material, is lighter, and occupies less space (e.g., when the pouch <NUM> is folded). Further, opening of the pouch <NUM> by an end user is simple and straightforward, and is not negatively affected by the presence of glutaraldehyde. The prosthetic heart valve <NUM> can be easily removed from the pouch <NUM>, and the sterilization solution <NUM> can conveniently be poured from the pouch <NUM> once the prosthetic heart valve <NUM> is removed. Moreover, the frame <NUM> and the liquid/sterilization solution <NUM> within the pouch <NUM> serve to protect the prosthetic heart valve <NUM> (e.g., the combination sterilization solution <NUM> and the pouch <NUM> act as a natural dampener).

Another embodiment of a packaging system <NUM> for storage and/or shipping of the prosthetic heart valve maintained within a sterilization solution (e.g., glutaraldehyde) in accordance with principles of the present disclosure is shown in <FIG>. The packaging system <NUM> includes a container assembly <NUM> (referenced generally) and an insulator body <NUM>. The container assembly <NUM> can be akin to steel or tin can packaging commonly used for consumable products such as soup, and includes a can or cup <NUM> and a lid <NUM>. The can <NUM> is sized and shaped to receive and maintain the prosthetic heart valve (hidden) and appropriate volume of the sterilization solution. In some embodiments, the can <NUM> is formed of a thin metal (tin-plated steel, tin-free steel, tin, aluminum, etc.). The lid <NUM> is provided as part of a top end wall joined to the can <NUM> that includes a score line <NUM> (referenced generally). Optionally, a pull tab <NUM> can be provided with the lid <NUM>. Prior to opening the lid <NUM>, the container assembly <NUM> provide a sealed, sterile environment for the prosthetic heart valve and sterilization solution (e.g., prior to opening, the sealed container assembly <NUM> is impervious to liquid and oxygen). The container assembly <NUM> combines with the prosthetic heart valve and the sterilization solution to define or provide a wet packaged prosthetic heart valve. As understood by virtually all users, the lid <NUM> is easily opened, for example by applying a pulling force onto the pull tab <NUM>, thus separating the lid <NUM> from the can <NUM> along the score line <NUM>. The presence of the sterilization solution does not affect the ease with which the lid <NUM> can be removed. As compared to conventional wet prosthetic heart valve packaging, the container assembly <NUM> is designed for ease of use and is globally used in other industries without issue.

The insulator body <NUM> can assume various forms, appropriate for providing thermal insulation to the wet packaged prosthetic heart valve. For example, the insulator body <NUM> can define an interior open volume sized and shaped to receive can <NUM>, and an exterior geometry conducive to shipping and storage (e.g., the insulator body <NUM> can have or form flat exterior surfaces as shown). A variety of materials are available that provide thermal insulation. In some non-limiting examples, the insulator body <NUM> is or includes a cork or cork-like material. With these and related embodiments, the cork material can improve recyclability of the packaging system <NUM> as compared to conventional designs. Other formats are also acceptable. For example, <FIG> illustrates another packaging system <NUM> in accordance with principles of the present disclosure that includes a container assembly <NUM> (referenced generally) and an insulator body <NUM>. With the embodiment of <FIG>, the insulator body <NUM> (e.g., cork or cork-like material) is provided as a sleeve that is fitted around the container assembly <NUM>.

The packaging systems of the present disclosure provide a marked improvement over previous designs. For example, wet packaged prosthetic heart valves are provided that are easy to open, and not susceptible to possible interference by the presence of crystalized glutaraldehyde or other sterilization solutions. Further, some embodiments provide enhance thermal and physical protection, eliminating the need for expensive, additional packaging.

Claim 1:
A packaging system (<NUM>) for storing a prosthetic heart valve (<NUM>) in a sterilization solution, the packaging system comprising:
a cup (<NUM>) sized to contain a prosthetic heart valve and a volume of a sterilization solution; and
a lid (<NUM>);
wherein the lid is securable to the cup to provide a sterile environment for the prosthetic heart valve and the sterilization solution;
and further wherein securement of the lid to the cup is characterized by the absence of a threaded interface between the lid and the cup;
wherein a wet packaged prosthetic heart valve (<NUM>) is generated upon placement of the prosthetic heart valve and sterilization solution into the cup and sealing of the lid onto the cup, the packaging system being characterized in that it further comprises:
a vacuum flask (<NUM>) sized to receive the wet packaged prosthetic heart valve.