Systems and methods for dry-packaged heart valves

Abstract

Systems and methods for dry-packaged heart valves. A system for dry storage of bioprosthetic heart valves includes a valve housing and a storage tray. The valve housing is sized to hold the heart valve and has a cavity that allows for the addition of hydration fluid prior to implantation. The lid is pivotally movable between open and closed positions to enclose the heart valve within the valve housing. The cavity in the valve housing is sized to prevent rotational and lateral movement of the bioprosthetic heart valve. The valve housing nests within the storage tray, and mating surfaces position the valve housing in a specific orientation and help resist rotational movement of the valve housing relative to the storage tray. The storage tray has a gas-permeable membrane, and the valve housing features an opening to allow the passage of sterilizing gas.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority to U.S. Provisional Patent Application No. 63 / 375,216, filed September 9, 2022, the disclosure of which is incorporated herein by reference in its entirety (including all drawings).

[0002] The present disclosure relates to packaging of medical devices, and more particularly to methods and systems for dry packaging tissue valves without a sterilizing solution. [Background technology]

[0003] Packaging bioprosthetic heart valves has presented many challenges. Bioprosthetic heart valves are traditionally packaged in a jar filled with a preservative solution for shipping and storage before use in the operating room. To minimize the potential for damage to the relatively delicate bioprosthetic heart valves, they are stabilized with a bracket structure to prevent contact with the inside of the jar.

[0004] Prior to implantation into a patient, the valve is removed from the jar and then rinsed in a stream of liquid or immersed in a bath of agitation. Surgical prosthetic valves typically have a centrally located, sutured valve holder; both holders are attached to the proximal end of the valve (the sewing ring for inflow in the case of the mitral valve, and the commissure tip for outflow in the case of the aortic valve) so that an attached surgical delivery handle extends proximally, away from the implant site.

[0005] Glutaraldehyde is widely used as a preservative solution due to its sterilizing properties, but it can contribute to calcification. Certain strategies to reduce the glutaraldehyde content in the final product have been demonstrated to mitigate calcification in vivo.

[0006] One such strategy involves dehydrating the bioprosthetic tissue in a glycerol / ethanol mixture, sterilizing it with ethylene oxide, and packaging the final product "dry." This process avoids the potential toxic and calcifying effects of glutaraldehyde as a sterilant and preservative. Because dehydrated prosthetic heart valves can absorb moisture from their surroundings, a moisture-resistant packaging system can be used.

[0007] Several methods have been proposed using glycerin, alcohols, polyols, sugars, sugar alcohols, hydrophilic polymers, and combinations thereof as glutaraldehyde posttreatment agents so that the resulting tissue is in a dehydrated or "dry" state rather than a wet state preserved in excess glutaraldehyde. These approaches avoid the use of aqueous liquid aldehydes or liquid sterilants as preservatives for tissues and devices. Glycerol-based methods can be used in storage systems such as those described in Parker et al. (Thorax 1978 33:638). Also, U.S. Patent No. 6,534,004 (Chen et al.) describes the treatment of bioprosthetic tissues using polyhydric alcohols such as glycerol.

[0008] In view of the development of dehydrated tissue heart valves, opportunities arise for alternative packaging for such valves that offer a combination of moisture protection, lower cost, and simplified field deployment. Summary of the Invention [Problem to be solved by the invention]

[0009] FIELD OF THE DISCLOSURE The present disclosure relates to packaging for medical devices, and more particularly to methods and systems for dry packaging biological heart valves. [Means for solving the problem]

[0010] In one embodiment, a system for dry storage of a bioprosthetic heart valve includes a valve housing sized to removably hold a bioprosthetic heart valve. The bioprosthetic heart valve has a stent diameter (d s) and a compressible fabric covering a portion of the outer surface of the stent, the covered portion having a stent diameter (d s ) larger than the diameter (d hv The valve housing may include a cavity having an upper cavity opening, a cavity lip surrounding the upper cavity opening, a bottom wall, and an inner wall. The cavity may be sized to accommodate the bioprosthetic heart valve and to hold a liquid for hydrating the bioprosthetic heart valve prior to implantation in a patient.

[0011] At least a portion of the opposing surfaces of the inner wall can be configured to contact the biological heart valve when the biological heart valve is positioned in the cavity. Rotation and lateral movement of the biological heart valve within the cavity can be prevented by contact between the opposing surfaces and the biological heart valve. In one aspect, the opposing surfaces of the inner wall can be spaced apart to compress only the compressible fabric of the biological heart valve, but not the stent. According to this aspect, the diameter (d s ) may remain substantially unchanged.

[0012] A lid may be provided for enclosing the upper cavity opening. The lid may be pivotally movable between an open position and a closed position. In the open position, the lid may be pivoted away from the upper cavity opening to provide access to the cavity. In the closed position, the lid may be frictionally secured to a cavity lip surrounding the upper cavity opening. In one embodiment, the lid may be pivotally movable between an open position exposing the upper cavity opening and a closed position covering the upper cavity opening.

[0013] In the closed position, the inner surface of the lid can face the bottom wall and the length (l hv ) which may be substantially the same as the distance (l lb ) to prevent movement of the bioprosthetic heart valve along the longitudinal axis of the bioprosthetic heart valve within the valve housing. lb ) is the length of the bioprosthetic heart valve when the lid is in the closed position (l hv), otherwise slightly longer.

[0014] The lid can further include a plurality of undulations around its periphery. In the closed position, the plurality of undulations can allow passage of sterilizing gas into the cavity. According to one aspect, the plurality of undulations can be formed from one or both of the lid periphery and the cavity lid. Thus, at least a portion of the lid periphery and at least a portion of the cavity lip surrounding the upper cavity can be joined together such that the plurality of undulations can form an opening into the cavity when the lid is in the closed position.

[0015] According to one aspect, the valve housing may further include an outer wall spaced apart from the inner wall, the outer wall providing an enlarged cavity volume for retaining a fluid for hydrating the biological heart valve.

[0016] In one example, the system can further include a storage tray in which the valve cavity can be nested. The storage tray can include a top tray opening and a microbial barrier membrane. The storage tray can be configured to receive and enclose the valve housing through the top tray opening, and the microbial barrier membrane can enclose the valve housing when secured to a tray lip surrounding the top tray opening.

[0017] According to one aspect, the storage tray may be formed from a single, unitary piece of material.

[0018] According to another aspect, the storage tray does not include separate parts physically joined together.

[0019] According to another aspect, the valve housing can be fully nested within the storage tray and microbial barrier membrane.

[0020] According to another aspect, the microbial barrier membrane may be permeable to sterilizing gases.

[0021] According to another aspect, the storage tray and valve housing may be configured to prevent rotational movement of the valve housing relative to the storage tray when the valve housing is enclosed within the storage tray.

[0022] According to another aspect, the storage tray and the valve housing may each include mating surfaces configured to contact one another when the valve housing is placed in the storage tray. The mating surfaces may be shaped or configured to inhibit rotational and lateral movement of the valve housing within the storage tray.

[0023] According to another aspect, the mating surfaces do not prevent removal of the valve housing from the storage tray and out of the top tray opening.

[0024] According to another aspect, the mating surfaces can be configured to position the valve housing in a particular orientation relative to the storage tray. In one aspect, the mating surfaces of the valve housing are configured to allow the valve housing to nest in one direction within the storage tray.

[0025] According to another aspect, the mating surfaces are not frictionally engaged with one another.

[0026] According to another aspect, the mating surface can include a male key formed from one of the valve housing and the storage tray, and a female key formed from the other of the valve housing and the storage tray.

[0027] According to another embodiment, the mesh can be formed as a U-shaped channel within the storage tray. The U-shaped channel has an open end, a closed end, and a channel width (W) between the open and closed ends. f According to another aspect, the male key can be formed as a protrusion on the valve housing that fits within the U-shaped channel. The protrusion can have a width equal to or larger than the channel width (W f ) smaller than the protrusion width (W p The term "U-shaped" can include shapes including V-shaped, T-shaped, W-shaped, and other shapes that allow for keying.

[0028] According to another embodiment, when the microbial barrier membrane is removed from the storage tray, the open end of the U-shaped channel may face the top tray opening so that the valve housing falls out of the storage tray when the storage tray is inverted.

[0029] According to another aspect, the storage tray may further comprise one or more finger holds formed from the exterior surface of the storage tray. The finger holds may further comprise grip-enhancing ridges.

[0030] According to another aspect, the storage tray can include inner tray sidewalls for securing the valve housing. The storage tray can further include outer tray sidewalls that can be spaced sufficiently from the inner tray sidewalls to allow a user to grasp the upper peripheral edge of the valve housing without touching the outer tray sidewalls or tray lip.

[0031] According to another aspect, the system may further comprise a moisture-proof container configured to receive the storage tray and the valve housing retained therein. In one aspect, the moisture-proof material may also be impermeable to moisture and gas.

[0032] According to another aspect, the system can further include an outer container configured to receive the moisture-proof container including the storage tray and the valve housing held therein. The outer container can include one or more sensors, such as a radio frequency identification (RFID) tag, a temperature sensor, or a relative humidity sensor.

[0033] According to one aspect, the outer container can include an RFID tag and a buffer to reduce signal interference.

[0034] According to another aspect, the system may include a temperature sensor and a temperature indicator that can display a signal when the enclosed space in the packaging assembly or a component within the packaging assembly is subjected to a temperature outside a predetermined temperature range. According to one aspect, the temperature sensor and the temperature indicator can be located within the outer container.

[0035] According to another aspect, the system may include a relative humidity sensor and a relative humidity indicator that can display a signal when the relative humidity within an enclosed space within the packaging assembly or within a component of the packaging assembly is outside a predetermined relative humidity range. According to one aspect, the relative humidity sensor and the relative humidity indicator can be located within a moisture-proof container.

[0036] According to another aspect, the system may further comprise a label having instructions to identify sterile and non-sterile contents, thereby enabling aseptic transfer of the bioprosthetic heart valve to the sterile field of the operating room.

[0037] Each feature or concept outlined above stands alone and can be combined with other features or concepts outlined above or with any other feature or concept disclosed in this application.

[0038] In another embodiment, a system for dry storage of a bioprosthetic heart valve is provided. The system may include a valve housing sized to removably retain the bioprosthetic heart valve. The valve housing may include a cavity sized to accommodate the bioprosthetic heart valve and to retain a liquid for hydrating the bioprosthetic heart valve prior to implantation into a patient. The cavity may include an upper cavity opening, a bottom wall, and an inner wall that contacts the bioprosthetic heart valve when the bioprosthetic heart valve is positioned within the cavity. The inner wall may prevent rotation and lateral movement of the bioprosthetic heart valve within the cavity.

[0039] The lid may be secured over the upper cavity opening. The lid may include an inner lid surface that faces the bottom wall of the cavity when the lid is in the closed position. The lid is pivotably movable between the open and closed positions.

[0040] One or more openings may be located to allow the passage of sterilizing gas into the cavity when the lid is in the closed position.

[0041] According to one embodiment, the valve housing is entirely molded by a molding method, which may be one or more selected from the group consisting of thermoforming, injection molding, blow molding, machining, and 3D printing.

[0042] According to one embodiment, the forming method is thermoforming.

[0043] According to one embodiment, the valve housing is made of a material made of thermoformed plastic, which may be polyethylene terephthalate glycol (PETG).

[0044] According to one aspect, the valve housing may be formed from a single, unitary material, as opposed to being constructed by joining separate materials. In one aspect, the valve housing does not include separate parts that are joined together.

[0045] According to one aspect, the valve housing may further include a cavity lip formed around the upper cavity opening, and the lid may be frictionally secured to the cavity lip.

[0046] According to one aspect, the valve housing can further include first and second offset tabs configured to allow a user to open the lid from a closed position to an open position with one hand, The first offset tab can be formed from the lid and the second offset tab can be formed from the cavity lip.

[0047] According to another embodiment, the one or more openings may be formed as one or more gaps between the lid and the cavity lip. In one embodiment, the openings may be created by a molding method without the need to punch holes or otherwise remove material from the valve housing.

[0048] According to another aspect, the lid can include a lid perimeter having a first set of contours and the cavity lip can include a second set of contours, the first and second sets of contours can combine to form one or more openings when the lid is in the closed position.

[0049] According to another aspect, the valve housing may include a living hinge between the cavity and the lid.

[0050] According to another aspect, a biological heart valve can include a stent and an outer surface. The stent can be made of a metal or metal alloy, and the outer surface can be a fabric. The fabric can surround at least a portion of the stent, and the fabric can have a loft that allows for radial compression of the biological heart valve. In one aspect, the fabric can surround a portion of the stent. In another aspect, the fabric can surround the entire stent.

[0051] According to another aspect, the inner wall of the cavity can be sized so that opposing surfaces of the inner wall can compress the bioprosthetic heart valve to removably retain the bioprosthetic heart valve within the cavity.

[0052] According to another aspect, the opposing surfaces of the inner wall can compress only the fabric of the biological heart valve, and not the stent.

[0053] According to another embodiment, the diameter (d hv ) is the distance between the opposing surfaces of the inner walls (l iw ) may be substantially the same as

[0054] According to another embodiment, the distance between the opposing surfaces of the inner wall (l iw) is the diameter of the bioprosthetic heart valve (d hv ) or less.

[0055] According to another embodiment, the distance between the opposing surfaces of the inner wall (l iw ) is the diameter of the stent (d s According to another embodiment, the distance between the opposing surfaces of the inner wall (l iw ) is the diameter of the bioprosthetic heart valve (d hv ) and the stent diameter (d s ) may be larger.

[0056] According to another aspect, the lid inner surface can face the bottom wall and extend along the length (l) of the bioprosthetic heart valve to prevent longitudinal movement of the bioprosthetic heart valve within the valve housing when the lid is in the closed position. hv ) may be spaced apart at substantially the same distance.

[0057] According to another aspect, the inner lid surface may include a cylindrical lid cavity that may be shaped to accommodate one of the outflow end or the inflow end of the bioprosthetic heart valve, depending on how the bioprosthetic heart valve is oriented within the valve holder. lc ) is the diameter of the stent (d s ) or the diameter of the bioprosthetic heart valve (d hv ) may be larger than

[0058] According to another aspect, the valve housing may further include indicia identifying the bioprosthetic heart valve. The indicia may be affixed to one or both of the lid and the bottom wall. The indicia may indicate the size of the bioprosthetic heart valve. The indicia may be thermoformed onto the lid and the bottom wall.

[0059] According to another aspect, the bioprosthetic heart valve may be secured within opposing surfaces of the inner wall by frictional engagement between the inner wall and the fabric.

[0060] According to another aspect, the bioprosthetic heart valve is not physically attached, secured, or embedded within the valve housing.

[0061] According to another aspect, the valve housing may further include an outer wall, the distance between opposing surfaces of the outer wall being greater than the distance between opposing surfaces of the inner wall, and the opposing surfaces of the outer wall not contacting the biological heart valve.

[0062] Each feature or concept outlined above stands alone and can be combined with other features or concepts outlined above or with any other feature or concept disclosed in this application.

[0063] Examples of packaging systems do not include a holder or housing to which the valve is mechanically secured, connected, or attached, for example, using sutures, one or more clips, or another mechanical fastener.

[0064] An example packaging system is substantially free of sterilant in the final product.

[0065] Various features described elsewhere in this disclosure may be included in the examples summarized herein, and various methods and steps for using the examples and features, including those described elsewhere herein, may be used. [Brief explanation of the drawings]

[0066] [Figure 1] FIG. 1 is an exploded perspective view of a storage system including a microbial barrier membrane, a bioprosthetic heart valve, a valve housing, and an open storage tray. [Figure 2A] FIG. 1 is an exploded perspective view of an example of an open storage tray and microbial barrier membrane. [Figure 2B] FIG. 2B is a top plan view of the open storage tray of FIG. 2A. [Figure 2C] FIG. 2B is a side view of the open storage tray taken from the view shown in FIG. 2A. [Figure 2D] FIG. 2B is a side view of the open storage tray taken from the view shown in FIG. 2A. [Figure 3A] FIG. 1 is a perspective view of an example valve housing with the lid in a closed position. [Figure 3B]FIG. 3B is a perspective view of the valve housing of FIG. 3A with the lid in an open position. [Figure 3C] FIG. 3B is a top view of the valve housing of FIG. 3A with the lid in the open position. [Figure 3D] 3B is a side view of the valve housing of FIG. 3A with the lid in a closed position, taken from the view shown in FIG. 3A. [Figure 4A] 1 is a perspective view of an exemplary tissue valve. [Figure 4B] FIG. 4B is a side view of the tissue valve of FIG. 4A. [Figure 5A] FIG. 4B is a perspective view of the bioprosthetic heart valve of FIG. 4A positioned within a valve housing. [Figure 5B] 5B is a cross-sectional view of the valve housing taken along 5B-5B of FIG. 3A. [Figure 6A] 3B is a perspective view of the valve housing of FIG. 3B nested within the storage tray of FIG. 2A. [Figure 6B] 6B is a cross-sectional view of the valve housing and biological valve assembly taken along 6B-6B of FIG. 6A. [Figure 7] 1 is a perspective view of an exemplary moisture-proof container that can be torn open. FIG. [Figure 8] FIG. 1 is a perspective view of an exemplary package having a sensor, a label, and an indicator. DETAILED DESCRIPTION OF THE INVENTION

[0067] The packaging system (100) is shown in Figure 1 as generally comprising an open storage tray (200) and a microbial barrier membrane (250), which, when assembled together, provide a fully enclosed cavity that can accommodate a valve housing (300). The valve housing (300) can, in turn, be sized to hold a bioprosthetic heart valve (10). Each of these components will be described in more detail with reference to the following figures.

[0068] The storage tray (200) is shown in Figures 1 and 2A-2D. The storage tray (200) comprises an open cavity (202) defined by a bottom (204), outer tray sidewalls (225), and a top tray opening (210). The top tray opening (210) terminates at a peripheral tray lip (212). Inner tray sidewalls (220) are formed within the cavity (202) and define a valve housing retention space therebetween. The inner tray sidewalls (220) are spaced and configured to accommodate a valve housing (300). A separate microbial barrier membrane (250) can be attached to the tray lip (212) to completely enclose the valve housing (300) within the cavity (202). The storage tray (200) may additionally feature grip-enhancing ridges (231) located on the sides of the formed finger holds (221) to enhance a user's grip on the storage tray (200).

[0069] The valve housing (300) is shown in Figures 3A-3D and 5A-5B. The valve housing (300) includes a cavity (340) and a lid (350) that is movable between a closed position (Figure 3A) and an open position (Figure 3B). The cavity (340) includes an inner wall (320) and a bottom wall (330) that define a valve space within which the bioprosthetic heart valve (10) can be held. The outer wall (325) can be spaced apart from the inner wall (320) to provide additional cavity volume for containing hydration fluid. The additional cavity volume provided by the outer wall (325) can be in fluid communication with the valve space so that the hydration fluid can bathe the bioprosthetic heart valve (10).

[0070] A lid 350 may be provided to cover the upper cavity opening 310 and enclose the bioprosthetic heart valve 10 within the cavity 340. The lid 350 may be pivotally connected to the cavity 340 by a hinge 360 ​​and may include an inner lid surface 356 centrally disposed on the lid 350. The lid 350 may be frictionally secured to the cavity lip 312.

[0071] In one embodiment, hinge (314) is a living or flexible hinge that includes one or more flexures, as shown in Figures 3B and 5A. Providing a living hinge (314) allows the lid (350), hinge (314), and cavity (340) to be molded or formed from the same material into a single, integral piece without the need for joining or physically attaching separate parts. Other examples of hinges include living hinges that do not include any flexures. In other embodiments, the lid and cavity of the valve housing are manufactured as separate components.

[0072] A pair of tabs 395A, 395B may further be provided to allow a user to separate the lid 350 from the cavity 340. In the embodiment shown in FIGS. 3A-3C, one tab 395A may be formed and extend from the cavity lip 312, and the other tab 395B may be formed and extend from the lid perimeter 355. The tabs 395A, 395B may be offset from one another to allow the lid 350 to be opened with one hand. In one method, opposing pressure may be applied to the tabs 395A, 395B with two fingers to separate them.

[0073] In particular, the example packaging system (100) does not include a holder or housing to which the tissue valve (10) is mechanically secured, connected, or attached, for example, using sutures, one or more clips, or another mechanical fastener. Omitting these features not only reduces costs by eliminating manufacturing steps, particularly manual steps, and reducing part count, but can also improve the end-user experience by eliminating the step of separating the valve from the holder.

[0074] Although packaging system (100) is illustrated as containing a biological heart valve (10), it is understood that packaging system (100) may be sized and adapted to contain other implantable medical devices requiring dry and sterile storage conditions.

[0075] As used herein, the term "dry" does not exclude the presence of any water or moisture, including liquid water, within or on the packaging or tissue valve. For example, some tissue valves contain tissue in which water is an inherent component, in which case it is undesirable to completely remove the water. Additionally, some manufacturing steps may include sterilization with at least some water, e.g., ethylene oxide or propylene oxide. Water droplets may also be present as condensate, especially at lower temperatures.

[0076] In an exemplary embodiment, the packaging system 100 can be used to store a bioprosthetic heart valve 10. Figures 4A-4B show the stent diameter (d s ) and the length (l hv 1 illustrates a bioprosthetic heart valve (10) comprising a stent or frame (12) having a stent-like structure (14). A valve structure (14) is secured to the inner surface of the stent (12), and a fabric (18) surrounds at least a portion of the outer surface of the stent (12) at the inflow end (13). Bioprosthetic heart valves (10) can vary in size. For bioprosthetic heart valves (10) intended for implantation into a patient's annulus, the bioprosthetic heart valves (10) can vary in diameter (e.g., 20 mm, 23 mm, 26 mm, and 29 mm). Thus, an appropriate bioprosthetic heart valve (10) can be selected based on the measured size of the patient's annulus.

[0077] In one embodiment, the fabric 18 may have thickness, loft, nap, or pile such that the fabric 18 is compressible. hv ) reflects the diameter measured at the widest part of the bioprosthetic heart valve, including the thickness of the fabric. Therefore, the diameter of the heart valve (d hv ) necessarily corresponds to the stent diameter (d s ) is greater than 184. U.S. Patent No. 11,123,184 is incorporated herein by reference in its entirety as if fully set forth herein. Other examples of biological heart valves have different structures, for example, one or more of a different stent structure or a different fabric structure.

[0078] The components of the packaging system (100) are designed to maintain the integrity of the bioprosthetic heart valve (10) during storage and transport. To this end, various features of the valve housing (300) and storage tray (200) are configured and dimensioned to reduce or prevent lateral (x-axis), longitudinal (y-axis), and / or rotational (r) movement about the y-axis of the bioprosthetic heart valve (10) relative to the valve housing (300) and storage tray (200) during transport. See FIG. 1.

[0079] In one embodiment, the opposing surfaces of the inner wall (320) of the valve housing (300) may be sized and configured to aid in stabilizing the bioprosthetic heart valve (10).

[0080] According to this embodiment, at least a portion of the opposing surfaces of the inner wall (320) are spaced apart by a distance (l iw ), which distance may be less than the diameter (d s ) but is approximately equal to or larger than the diameter (d hv ) is smaller than :d hv > l iw > d s

[0081] When configured accordingly, the opposing surfaces of the inner wall (320) can compress the biological heart valve (10), and the compressed fabric (18) can provide sufficient friction to prevent lateral, longitudinal and / or rotational movement of the biological heart valve (10) within the valve housing (300).

[0082] A portion of the opposing surface of the inner wall (320) is separated by a distance (l iw ) separation allows the bioprosthetic heart valve (10) to be frictionally held between the opposing surfaces of the inner wall (320), but the frictional force is not so strong that the bioprosthetic heart valve (10) cannot be removed by hand or is difficult to remove.

[0083] In one embodiment, the distance (liw ) is the diameter (d hv ) but reduces the diameter of the stent (d s The frictional retention is selected so that the stent is not compressed so that the axial length of the stent (12) remains unchanged. This frictional retention may be sufficient to prevent lateral and rotational movement of the bioprosthetic heart valve (10) within the valve housing (300) without permanently distorting the structural components of the bioprosthetic heart valve (10), such as the stent (12). In other words, the frictional retention is tailored to hold the bioprosthetic heart valve (10) without permanently or adversely altering or affecting the structural integrity of the stent (12).

[0084] In some embodiments, the portion of the inner wall 320 that contacts the bioprosthetic heart valve 10 is sufficiently deformable to expand slightly upon insertion, thereby frictionally engaging the bioprosthetic heart valve 10 without deforming or otherwise damaging the heart valve. Such a feature is desirable, for example, when the heart valve 10 includes a portion that lacks fabric in contact with the inner wall.

[0085] It will be appreciated that this frictional retention of the bioprosthetic heart valve (10) provided by the opposing surfaces of the inner wall (320) can be achieved in a variety of ways. For example, the opposing surfaces of the inner wall (320) may extend a distance (l) along their entire height from the bottom wall (330) toward the cavity opening (310). iw ) may be separated.

[0086] Alternatively, when the distance between the portions of the opposing surfaces of the inner wall (320) is narrowed, only the portions of the opposing surfaces of the inner wall (320) are within the distance (l iw ) may be separated.

[0087] In a further alternative, the opposing surfaces of the inner wall are such that a portion of the inner wall (320) is spaced apart by a distance (l iw ) and the remaining parts are separated by a distance (l iw), the opposing surfaces of the inner wall (320) may spread apart toward the cavity opening (310) to facilitate removal of the bioprosthetic heart valve (10).

[0088] Although the embodiment shown in Figures 3B-3D depicts the inner wall (320) having two separate opposing walls (320A, 320B), it is understood that the inner wall (320) can be configured as a single continuous wall.

[0089] The valve housing 300 may be further dimensioned to prevent or limit longitudinal movement of the bioprosthetic heart valve 10 within the valve housing 300. In one embodiment, the lid 350 has a distance (l) between the lid inner surface 356 and the bottom wall 330 when the lid 350 is in the closed position. lb ) is the length (l hv ) can be configured to be substantially the same as

[0090] In one embodiment, the lid (350) may further include a raised edge (354) extending beyond and surrounding the lid inner surface (356) such that a recessed lid cavity (358) is defined to accommodate one end (e.g., the inflow end (13) or the outflow end (15)) of the biological heart valve (10).

[0091] In one aspect of this embodiment, when the lid (350) is in the closed position, the distance (l) between the lid inner surface (356) and the bottom wall (330) is lb ) is the length (l hv ) is slightly larger than

[0092] In one embodiment, the recessed cavity (358) defined by the raised edge (354) accommodates the ends not covered by the fabric and reduces the diameter (d s ) and a diameter (d lcIn another embodiment, the recessed cavity (358) defined by the raised edge (354) accommodates the fabric-covered end, thus reducing the diameter (d hv ) and a diameter (d lc ) the recessed cavity diameter (d ) slightly larger than the end of the bioprosthetic heart valve (10) housed within the recessed cavity (358). lc ), reduces the likelihood that the raised edges (354) will come into contact with the bioprosthetic heart valve (10) when the lid (350) is pivotally actuated from the open position (FIG. 3B) and the closed position (FIG. 3A). At the same time, the raised edges (354) provide additional structure that can prevent or limit lateral movement of the bioprosthetic heart valve (10) within the valve housing (300).

[0093] Because the valve housing (300) provides sterile containment of the biological heart valve (10), the valve housing (300) may include one or more openings (390) to allow the passage of sterilizing gas into the cavity (340) when the lid (350) is in the closed position (FIG. 3A).

[0094] In one embodiment, one or more openings (390) are formed when the lid (350) is secured to the cavity lip (312). According to the embodiment shown in Figures 3A and 3B, the cavity lip (312) of the valve housing (300) can include a recess or undulation (390A) that curves away from the lid (350) when the lid (350) is in the closed position (Figures 3A-3D and 5A). The lid perimeter (355) can include a correspondingly positioned curved recess or undulation (390B) that curves away from the cavity (340) when the lid (350) is in the closed position (Figure 3B). When the lid (350) is secured onto the cavity lip (312), the recesses or undulations (390A, 390B) collectively form an opening or channel (390) through which sterilizing gas can enter the cavity (340).

[0095] In one embodiment, the depressions or undulations (390A, 390B) may be created by thermoforming. In another embodiment, the one or more openings (390) are not created in the valve housing (300) by punching, cutting, or otherwise removing material from the valve housing (300), which operations may generate undesirable particles. Thus, according to this embodiment, the valve housing (300) does not include any openings or features that result from the removal of material from the valve housing (300).

[0096] Other embodiments of the valve housing do not include openings, for example, when sterilization gas is not used in the manufacturing process, such as in the case of sterilization by radiation, electron beam, gamma radiation, ultraviolet light, microwave radiation, plasma, heat, steam, or liquid sterilant.

[0097] The valve housing (300) is configured to provide secure retention of the bioprosthetic heart valve (10), however the valve housing (300) may be shaped and configured to be securely held within the storage tray (200).

[0098] 6A-6B show the valve housing (300) positioned within the storage tray (200). The inner tray sidewall (220) of the storage tray (200) and the facing outer surface (327) of the outer wall (325) of the valve housing (300) are sized, configured, and / or shaped to prevent or limit rotational movement of the valve housing (300) relative to the storage tray (200). This feature is advantageous in providing an additional stabilizing feature for the bioprosthetic heart valve (10).

[0099] As shown in Figures 6A-6B, the valve housing (300) can be configured to nest completely within the storage tray (200). In one embodiment, the valve housing (300) can be sized to nest within a valve housing retention space (222) defined between opposing surfaces of the inner tray sidewalls (220). In one embodiment, the inner tray sidewalls (220) partially surround the valve housing (300), as shown. In another embodiment, the inner tray sidewalls completely surround the valve housing (300).

[0100] In one embodiment, the valve housing 300 has a curved outer wall surface 327. The inner tray sidewalls 220 may be provided with corresponding curved shapes facing opposite sides of the outer wall surface 327 of the valve housing 300.

[0101] It may be desirable for the packaging system (100) to have one or more features that can prevent or reduce longitudinal, lateral, and / or rotational movement of the valve housing (300) relative to the storage tray (200) during transport.

[0102] In one embodiment, the inner tray sidewall 220 may be shaped to at least partially conform to the contour of the outer wall surface 327 to reduce, limit, or prevent lateral movement of the valve housing 300 relative to the storage tray 200. It is understood that a gap may be provided between the inner tray sidewall 220 and the outer wall surface 327 of the valve housing 300. Nevertheless, lateral movement can be prevented if the gap is sufficiently small. In one embodiment, lateral movement is prevented as long as the gap between the opposing surface of the inner tray sidewall 220 and the outer wall surface 327 is about 5 mm or less, about 4 mm or less, about 3 mm or less, about 2 mm or less, about 1 mm or less, or about 0.5 mm or less, or within a range inclusive of any two of the foregoing values. Thus, for example, the gap between the opposing surface of the inner tray sidewall 220 and the outer wall surface 327 may be about 3 mm or less.

[0103] In another example, a portion of the inner tray sidewall (220) and the facing outer wall surface (327) may be in physical or frictional contact with one another such that a pulling force (F) is required to disengage the valve housing (300) from the storage tray (200). In one example, the pulling force (F) can be about 10 N or less, about 9 N or less, about 8 N or less, about 7 N or less, about 6 N or less, about 5 N or less, about 4 N or less, about 3 N or less, about 2 N or less, about 1 N or less, or about 0.5 N or less. The pulling force (F) can also be applied within a range inclusive of and between any two of the foregoing values.

[0104] In another embodiment, the inner tray sidewalls 220 may be spaced apart from the facing outer wall surface 327 so that there is minimal or no physical contact or frictional engagement between the inner tray sidewalls 220 and the valve housings 300. According to this embodiment, the valve housings 300 can be disengaged or removed from the storage tray 200 simply by inverting the storage tray 200. For example, the storage tray 200 can be inverted to allow the valve housings 300 to simply drop from the top tray opening 210 onto a recipient or surface in the sterile field. This minimizes the risk of physical contact with non-sterile portions of the storage tray 200 during aseptic transfer of the bioprosthetic heart valve 10 to the sterile field. According to this embodiment, no frictional contact is provided between the storage tray 200 and the valve housings 300, and therefore no force is required to remove the valve housings 300 from the storage tray 200.

[0105] In one embodiment, longitudinal movement of the valve housing (300) relative to the storage tray (200) can also be further prevented by relying on specific structural features of the storage tray (200). In one embodiment, the storage tray (200) can be dimensioned such that the microbial barrier membrane (250) is positioned on the tray lip (212) adjacent to or in contact with the lid (350) of the valve housing (300). According to this embodiment, when the microbial barrier membrane (250) is attached to the tray lip (212), the microbial barrier membrane (250) can be spaced from the top of the valve housing (300) by about 5 mm or less, about 4 mm or less, about 3 mm or less, about 2 mm or less, about 1 mm or less, or about 0.5 mm or less. According to another embodiment, the microbial barrier membrane (250) can be in contact with the lid (350) of the valve housing (300). In another embodiment, the storage tray (200) may include tabs or protrusions that contact or interact with the valve housing (300) to prevent or limit longitudinal movement of the valve housing when the microbial barrier membrane (250) is assembled on the storage tray (200).

[0106] The microbial barrier membrane (250) can be made of a material capable of creating a microbial barrier. One suitable gas-permeable material is available as a sheet of high-density polyethylene fibers that is tear-resistant but can be easily cut, for example, using scissors or a knife. In one example, the gas-permeable material allows water vapor and gas to pass through the fibers, but not liquid water. According to this example, a nonwoven material, for example, nonwoven polyethylene fibers (e.g., Tyvek® spun polyethylene, DuPont), can be used. A hot melt adhesive can be used to secure the microbial barrier membrane (250) to the tray lip (212).

[0107] The microbial barrier membrane (250) may be adhered to the tray lip (212) with an adhesive. Suitable adhesives may include a hot melt adhesive, a pressure seal adhesive, or a heat seal adhesive. The microbial barrier membrane (250) may be made from a breathable or gas permeable material to provide gas sterilization of the contents sealed within the storage tray (200). One suitable gas permeable material is a sheet of high-density polyethylene fiber, which is difficult to tear but easily cut with scissors. In one embodiment, the microbial barrier membrane is permeable to gases but impermeable to liquid water.

[0108] Rotational movement of the valve housing 300 relative to the storage tray 200 can also be prevented or limited. This can be achieved by providing a mating key pair that includes a male key and a female key. In one embodiment, the storage tray 200 can include one of the male or female keys, and the valve housing 300 can include the other of the male or female keys. This keying mechanism eliminates six degrees of freedom (three translational and three rotational) between the valve housing and the storage tray, thereby reducing uncertainty and simplifying quality control, facilitating verification, and facilitating regulatory approval, as well as eliminating "whack" and product misalignment that could risk perceived quality defects by end users.

[0109] In the embodiments illustrated in Figures 1, 2A and 2B, 3A-3D, 5B, and 6B, the storage tray (200) is illustrated as including a mess key (280), and the valve housing (300) is illustrated as including a male key (380). It is understood that the assignment of the male key or mess key to the storage tray (200) or valve housing (300) can be reversed, such that the valve housing (300) can include a mess key (280) and the storage tray (200) can include a male key (380). The illustrated embodiment includes one set of keys between the storage tray and the valve housing. Other embodiments may include two or more sets of keys.

[0110] In one embodiment, the messenger key 280 is thermoformed from the storage tray 200, and the male key 380 is thermoformed from the valve housing 300. In one embodiment, the mating key pair 280, 380 may be friction-fit with close tolerances between the surfaces of the messenger key 280 and the male key 380. In this embodiment, there is little or no rotational movement of the valve housing 300 relative to the storage tray 200.

[0111] In another embodiment, engagement of the mating key pair may be configured to not impede removal of the valve housing 300 from the storage tray 200. As previously mentioned, it may be desirable for the valve housing 300 to fall unassisted from the storage tray 200 when the open end of the storage tray 200 is inverted. Thus, in one embodiment, the mess key 280 may be formed as a U-shaped channel, with the opening of the "U" facing the open end of the storage tray 200, and the male key 380 may be formed as a protrusion that fits within the mess key 280, preferably without friction.

[0112] In a further embodiment, the facing surfaces of the mesh key 280 and the male key 380 can be adapted so that a small gap exists between the two surfaces, which facilitates removal of the valve housing 300 from the storage tray 200 while preventing significant rotational movement of the valve housing 300 within the storage tray 200.

[0113] In one embodiment, the gap between the facing surfaces of the mesh key (280) and the os key (380) is about 5 mm or less, about 4 mm or less, about 3 mm or less, about 2 mm or less, or about 1 mm or less.

[0114] In another embodiment, rotational movement of the valve housing (300) relative to the storage tray (200) is prevented when rotational movement of the valve housing (300) about the y-axis (FIG. 1) is 15 degrees or less, 14 degrees or less, 13 degrees or less, 12 degrees or less, 11 degrees or less, 10 degrees or less, 9 degrees or less, 8 degrees or less, 7 degrees or less, 6 degrees or less, 5 degrees or less, 4 degrees or less, 3 degrees or less, 2 degrees or less, 1 degree or less, or within a range including and between any two of the foregoing values.

[0115] In one embodiment, the storage tray (200) can include an outer tray sidewall (225) spaced apart from the inner tray sidewall (220). In the embodiment shown in Figures 2A-2D, the outer tray sidewall (225) terminates in a tray lip (212) and is spaced apart from the opposing surface of the inner tray sidewall (220) sufficiently to allow a user to grasp the upper peripheral edge (301) of the valve housing, as shown in Figures 6A-6B.

[0116] As mentioned above, in one embodiment, the tray lip (212) is positioned a sufficient distance from the inner tray sidewall (220) so that a user's fingers can grasp the valve housing (300) residing within the valve housing retention space (222) without the fingers coming into contact with the non-sterile portion of the storage tray (200). The non-sterile portion of the storage tray may include the tray lip (212) and the outer surface of the outer tray sidewall (225).

[0117] In one embodiment, one or both of the storage tray 200 and the valve housing 300 may be thermoformed entirely from a single material. In one embodiment, the thermoformed material may be a plastic or polymer, such as polypropylene (PP), polystyrene (PS), polyethylene terephthalate (PET), polyethylene terephthalate glycol (PETG), low-density polyethylene (LDPE), high-density polyethylene (HDPE), polyvinyl chloride (PVC), polycarbonate (PC), polymethyl methacrylate (PMMA), acrylonitrile-butadiene-styrene (ABS), and blends thereof. In a preferred embodiment, one or both of the storage tray 200 and the valve housing 300 are made of the same material, such as PETG. Manufacturing both components from the same material can improve the recyclability of the packaging system. The thermoformed material may be completely opaque, semi-opaque, or transparent. In a preferred embodiment, the thermoformed material is transparent to allow visualization of the valve housing 300 contained within the valve housing retention space 222.

[0118] In one embodiment, one or both of the storage tray (200) and the valve housing (300) may be made of a transparent material, allowing visualization of the bioprosthetic heart valve (10) and the valve housing (300) prior to removing the microbial barrier membrane (250) of the storage tray (200). In one embodiment, identification indicia (399) may be provided on one or both of the lid (350) and bottom wall (330) of the valve housing (300). Because the storage tray (200) is transparent, the identification indicia (399) may be visible without removing the microbial barrier membrane (250) of the storage tray (200). As shown in FIGS. 1 and 3A-3D, the identification indicia may be any information related to characteristics of the bioprosthetic heart valve (10), such as the size and / or model of the bioprosthetic heart valve (10).

[0119] In one embodiment, the packaging system 100 is assembled by placing the bioprosthetic heart valve 10 between the opposing surfaces of the inner walls 320 of the valve housing 300 and closing the lid 350 to enclose the bioprosthetic heart valve 10. The valve housing 300 containing the bioprosthetic heart valve 10 is then placed inside the storage tray 200 such that the oscilloscope 380 associated with the valve housing 300 is positioned inside the oscilloscope 280 associated with the storage tray 200. Using an appropriate adhesive and packaging system 100, the microbial barrier membrane 250 is secured to the storage tray 200 to enclose the valve housing 300 and the bioprosthetic heart valve 10, and the assembled packaging system is subjected to a sterilization process. The sterilization process is selected based on the characteristics of the medical device and the packaging and may include gas sterilization, radiation, gamma irradiation, electron beam irradiation, microwave irradiation, plasma, ozone, steam, or heat. In one embodiment, the sterilization is gas sterilization, more particularly sterilization with ethylene oxide. Preferably, the sterilization method selected does not produce hazardous or toxic by-products.

[0120] Embodiments of the packaging system 100 are substantially free of residual or terminal sterilant within the end-user product. The tissue valve 10 is sterilized using a non-permanent sterilant or sterilization method and maintained in a sterile state by the packaging system. As a result, the end-user is not exposed to residual or terminal sterilant when removing the tissue valve 10 from the packaging system 100, thereby reducing potential exposure to hazardous materials and reducing the use of such materials throughout the supply chain.

[0121] In one embodiment, the assembled packaging system may be further packaged within a moisture-proof container (60). The moisture-proof container (60) may be made of any suitable material that is impermeable to both moisture and even gas. An example of such a material is a foil pouch, which typically includes an aluminum or cobalt foil layer laminated between one or more polymer layers, such as, for example, polyester, polyamide, and / or polyethylene. Some embodiments include a portion configured for tear-opening (62), including, for example, a notch, tear tab, or tear strip as shown in FIG. 7. The moisture-proof container (60) may be further contained within an outer container (50), such as a box or carton.

[0122] In one example, the packaging system (100) may include one or more sensors (52), such as a radio frequency identification (RFID) tag, including an optional buffer to reduce signal interference, a temperature sensor, and a relative humidity sensor. While the sensor (52) is illustrated in FIG. 8 as being located within the outer container, it is understood that the one or more sensors may be located within the moisture-resistant container (60), the storage tray (200), and / or the valve housing (300). In one aspect, the one or more sensors (52) may be located on the outer container (50) and / or within an enclosed space defined within the outer container (50), the moisture-resistant container (60), the storage tray (200), or the valve housing (300). RFID tags may be used, for example, to uniquely identify a package or device, useful for cataloging or reporting the precise identity of a prosthetic valve used in a particular procedure. RFID technology enables automation of steps that are traditionally performed manually, thereby improving efficiency and reducing errors. In some embodiments, the RFID tag replaces a human-readable identification tag that is often attached to the prosthetic valve using, for example, sutures.

[0123] In further embodiments, the packaging system (100) may also include one or more indicators (54) capable of displaying a message if the packaging system (100) is subjected to environmental conditions, as detected by one or more sensors, that exceed acceptable limits for storage of the bioprosthetic heart valve (10). In one embodiment, the indicators (54) may be located on the outer container (50) and / or within an enclosed space defined within the outer container (50), the moisture-proof container (60), the storage tray (200), or the valve housing (300). In the embodiment shown in FIG. 8, the indicators (54) may be located within the outer container (50) but are visible through a transparent window without opening the outer container.

[0124] In one embodiment, the sensor (52) is a temperature sensor and the indicator (54) is a temperature indicator capable of displaying a signal if, during storage and transportation, the outer container (50) is subjected to a temperature outside a predetermined acceptable range for the bioprosthetic heart valve (10).

[0125] In another embodiment, the sensor 52 is a relative humidity sensor and the indicator 54 is a relative humidity indicator that can provide a signal when the relative humidity sensor detects a relative humidity that is outside a predetermined acceptable range for the bioprosthetic heart valve 10.

[0126] In one embodiment, instructions for moving the packaging system (100) from a non-sterile field to a sterile field may be associated with the outer container (50). The instructions may be provided on a label (56) affixed to the exterior of the outer container (50), as shown in Figure 8, or may be provided as a separate sheet included with the outer container (50). The instructions may identify the non-sterile components (e.g., the outer container (50) and the moisture-proof container (60)) and the sterile components (e.g., the packaging system 100).

[0127] Once the outer container 50 is received, the temperature indicator is referenced to determine if the outer container 50 has been subjected to an unacceptable temperature. If the outer container 50 has not been subjected to an unacceptable temperature excursion, the moisture-proof container 60 is removed from the outer container 50. It is understood that these steps are typically performed in a non-sterile field.

[0128] Transfer of the storage tray 200 from the non-sterile field to the sterile field begins with the opening of the moisture-proof container 60. In one embodiment, the moisture-proof container 60 includes a relative humidity sensor. A relative humidity indicator is referenced to determine whether the relative humidity has exceeded an acceptable range. In one embodiment, a person in the non-sterile field can open the moisture-proof container 60, and another person in the sterile field can carefully receive the packaging system 100. In another embodiment, a person can simply open the moisture-proof container 60 and simply transfer the packaging system 100 onto a surface in the sterile field. It is understood that the person in the non-sterile field avoids any direct physical contact with the packaging system 100. Once in the sterile field, the microbial barrier membrane 250 can be carefully removed from the storage tray 200. The valve housing (300) can then be carefully removed from the storage tray (200) by grasping the upper peripheral edge (301) of the valve housing (300) without touching the outer tray sidewall (225) or the tray lip (212).

[0129] As previously described, the valve housing (300) can be delivered to a sterile area, such as an operating room, by either carefully grasping the sides of the valve housing (300) and lifting it off the storage tray (200), or by simply inverting the storage tray (200) toward the recipient or area and allowing the valve housing (300) to fall. The valve housing (300) can then be opened by moving the tabs (395A, 395B) away from each other. In the embodiment shown in Figures 3A-3D, one tab (395A) extends from the cavity lip (312) and the other tab (395B) extends from the lid (350). The tabs (395A, 395B) may be offset to allow for one-handed separation. Once opened, the bioprosthetic heart valve (10) may be hydrated within the cavity (340) by adding a solution, such as saline, to soak the valve therein prior to implantation.

[0130] It will be appreciated that the foregoing description provides an improved packaging assembly featuring a desired range of interference forces over a greater range of interference widths, thereby maintaining a bioprosthetic heart valve securely within the packaging system while also allowing for easy removal of the heart valve from the packaging system without damage or contamination.

[0131] Although any methods and materials similar or equivalent to those described can be used in the practice or testing of the examples, specific methods, devices, and materials are described. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which these examples belong.

[0132] The terms "a," "an," and "at least one" include one or more of the specified elements. That is, if two of the specified elements are present, then one of these elements is also present, and thus "an" element is present. The terms "plurality" and "plurality" refer to two or more of the specified elements. The term "or" used between the last two elements of a list of elements refers to any one or more of the listed elements. For example, the phrase "A, B, or C" means "A, B, and / or C," which means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C." The term "coupled" generally means physically coupled or linked and does not exclude the presence of intermediate elements between the coupled items unless specifically stated to the contrary.

[0133] Without further elaboration, the preceding description is believed to enable one skilled in the art to make and use the same to its fullest extent. The detailed description provides only presently preferred embodiments. Those skilled in the art will understand that various modifications can be made without departing from the scope of the present disclosure, which is defined solely by the claims that follow.

Claims

1. 1. A system for dry storage of a bioprosthetic heart valve, said system comprising: Stent diameter (d ｓ ) and a stent having a diameter (d ｈｖ a compressible fabric covering at least a portion of the exterior surface of the stent, the compressible fabric having: a cavity sized to accommodate the bioprosthetic heart valve and to receive and retain a liquid for hydrating the bioprosthetic heart valve prior to implantation in a patient, the cavity including an upper cavity opening, a cavity lip surrounding the upper cavity opening, a bottom wall, and an inner wall; When the bioprosthetic heart valve is positioned in the cavity, opposing surfaces of the inner wall contact the bioprosthetic heart valve to prevent rotation and lateral movement of the bioprosthetic heart valve within the cavity; At least a portion of the opposing surface of the inner wall compresses only the compressible fabric of the bioprosthetic heart valve and reduces the diameter (d ｓ a cavity spaced apart so that the stent does not compress so that the stent's internal diameter (H) remains substantially unchanged; a lid having a lid periphery, the lid being pivotally movable between an open position exposing the upper cavity opening and a closed position covering the upper cavity opening; a plurality of undulations formed on one or both of the lid perimeter and the cavity lip; In the closed position: at least a portion of the lid perimeter and at least a portion of the cavity lip surrounding the upper cavity are joined together; the plurality of undulations permit passage of sterilizing gas between the lid periphery and the cavity lip and into the cavity to sterilize the bioprosthetic heart valve; The inner surface of the lid faces the bottom wall, and the length (l ｈｖ ) and the distance (l ｌｂ ) to prevent movement of the bioprosthetic heart valve along a longitudinal axis of the bioprosthetic heart valve within the valve housing.

2. 10. The system of claim 1, wherein the valve housing further comprises an outer wall spaced from the inner wall, the outer wall expanding the volume of the cavity to hold a liquid for hydrating the biological heart valve.

3. 3. The system of claim 1 or claim 2, further comprising a storage tray having an upper tray opening and a microbial barrier membrane, the storage tray configured to receive the valve housing through the upper tray opening and to enclose the valve housing when the microbial barrier membrane is secured to a tray lip surrounding the upper tray opening.

4. The system of claim 3 , wherein the storage tray is formed from a single, integral piece of material.

5. The system of claim 3 , wherein the storage tray does not comprise separate parts physically joined together.

6. The system of any of claims 3 to 5, wherein the valve housing is fully nested within the storage tray and microbial barrier membrane.

7. The system of any one of claims 3 to 6, wherein the microbial barrier membrane is permeable to sterilizing gas.

8. 8. The system of claim 3, wherein the storage tray and the valve housing are configured to prevent rotational movement of the valve housing relative to the storage tray when the valve housing is enclosed within the storage tray.

9. The system of claim 8 , wherein the storage tray and the valve housing each include mating surfaces configured to contact one another when the valve housing is placed within the storage tray.

10. The system of claim 9 , wherein the mating surface is configured to prevent rotational and lateral movement of the valve housing within the storage tray.

11. 11. The system of claim 9 or claim 10, wherein the mating surface does not prevent removal of the valve housing from the storage tray and out of the top tray opening.

12. The system of any of claims 9 to 11, wherein the mating surface is configured to position the valve housing in a particular orientation relative to the storage tray.

13. The system of any of claims 9 to 12, wherein the mating surfaces do not frictionally engage one another.

14. 14. The system of claim 9, wherein the mating surfaces comprise a male key formed from one of the valve housing and the storage tray, and a female key formed from the other of the valve housing and the storage tray.

15. The mesh has an open end, a closed end, and a channel width (W) between the open and closed ends on the storage tray. ｆ ) and the male key is formed as a protrusion on the valve housing that fits within the U-shaped channel, and the protrusion has a width equal to or larger than the channel width (W ｆ ) smaller than the protrusion width (W ｐ 15. The system of claim 14, further comprising:

16. 16. The system of claim 15, wherein when the microbial barrier film is removed, the open end of the U-shaped channel faces the upper tray opening so that the valve housing falls from the storage tray when the storage tray is inverted.

17. The system of any of claims 3 to 16, wherein the storage tray further comprises one or more finger holds formed from an outer surface of the storage tray.

18. 20. The system of claim 17, wherein the fingerhold further comprises a grip-enhancing ridge.

19. 19. The system of any one of claims 3 to 18, wherein the storage tray comprises an inner tray sidewall for securing the valve housing, and an outer tray sidewall is spaced sufficiently apart from the inner tray sidewall to allow a user to grasp the upper peripheral edge of the valve housing without touching the outer tray sidewall.

20. The system of any of claims 3 to 19, further comprising a moisture-proof container configured to receive the storage tray and the valve housing held therein.

21. 21. The system of claim 20, wherein the moisture-proof enclosure is impermeable to gases.

22. 22. The system of claim 20 or claim 21, further comprising an outer container configured to receive the storage tray and the moisture protector including the valve housing held therein.

23. 23. The system of claim 22, comprising one or more of a radio frequency identification (RFID) tag, a temperature sensor, or a relative humidity sensor.

24. 24. The system of claim 23, comprising an RFID tag, the outer container further comprising a buffer to reduce signal interference.

25. 25. The system of claim 23 or claim 24, wherein the system comprises a temperature sensor, and the outer container further comprises a temperature indicator, the temperature indicator displaying a signal when the outer container is subjected to a temperature outside a predetermined temperature range.

26. 26. The system of claim 23, further comprising a relative humidity sensor enclosed within the moisture-proof enclosure, and a relative humidity indicator that displays a signal when the relative humidity sensor detects a relative humidity outside a predetermined relative humidity range.

27. 27. The system of claim 22, further comprising a label having instructions for identifying sterile and non-sterile contents to enable aseptic transfer of the bioprosthetic heart valve to a sterile field in an operating room.

28. 1. A system for dry storage of a bioprosthetic heart valve, said system comprising: a valve housing sized to removably retain a biological heart valve, said valve housing comprising: a cavity sized to accommodate a bioprosthetic heart valve and to hold a liquid for hydrating the bioprosthetic heart valve prior to implantation into a patient, the cavity comprising an upper cavity opening, a bottom wall, and an inner wall that contacts the bioprosthetic heart valve when the bioprosthetic heart valve is positioned within the cavity to prevent rotational and lateral movement of the bioprosthetic heart valve within the cavity; a lid configured to be secured to the upper cavity opening, the lid having an inner lid surface facing the bottom wall of the cavity when the lid is in a closed position, the lid being pivotally movable between an open position and a closed position; one or more openings that allow the passage of sterilizing gas into the cavity when the lid is in the closed position; A system comprising:

29. 30. The system of claim 28, wherein the valve housing is formed entirely by a single molding process.

30. 30. The system of claim 29, wherein the molding method is one or more selected from the group consisting of thermoforming, injection molding, blow molding, machining, and 3D printing.

31. 31. The system of claim 30, wherein the forming method is thermoforming.

32. 30. The system of claim 28, wherein the valve housing is made from a material comprising thermoformed plastic.

33. 33. The system of claim 32, wherein the thermoformed plastic is polyethylene terephthalate glycol (PETG).

34. 34. The system of any of claims 28 to 33, wherein the valve housing further comprises a cavity lip formed around the upper cavity opening, the lid being frictionally secured to the cavity lip.

35. 35. The system of claim 34, wherein the valve housing further comprises first and second offset tabs configured to allow a user to open the lid from a closed position to an open position with one hand, the first offset tab being formed from the lid and the second offset tab being formed from the cavity lip.

36. 36. The system of claim 34 or claim 35, wherein the one or more openings are formed as one or more gaps between the lid and the cavity lip.

37. 37. The system of claim 36, wherein the lid comprises a lid perimeter having a first set of contours and the cavity lip comprises a second set of contours, the first and second sets of contours together forming the one or more openings when the lid is in a closed position.

38. A system according to any one of claims 28 to 37, wherein the valve housing comprises a living hinge between the cavity and the lid.

39. The system of any of claims 28 to 38, wherein the biological heart valve comprises a stent and an exterior surface.

40. 40. The system of claim 39, wherein the stent comprises a metal or metal alloy and the exterior surface comprises a fabric.

41. 41. The system of claim 40, wherein the fabric surrounds at least a portion of the stent, the fabric having a loft that allows radial compression of the biological heart valve without damaging it.

42. 42. The system of claim 41, wherein the fabric surrounds at least a portion of the entire stent.

43. 43. The system of claim 42, wherein the inner wall of the cavity is dimensioned such that opposing surfaces of the inner wall compress the bioprosthetic heart valve to removably retain the bioprosthetic heart valve within the cavity.

44. 44. The system of claim 43, wherein the opposing surfaces of the inner wall compress only the fabric of the bioprosthetic heart valve and not the stent.

45. The diameter (d ｈｖ ) is the distance (l) between the opposing surfaces of the inner wall ｉｗ 45. The system of claim 44, wherein the

46. The distance between the opposing surfaces of the inner wall (l ｉｗ ) is the diameter (d ｈｖ 45. The system of claim 44, wherein the

47. The distance between the opposing surfaces of the inner wall (l ｉｗ ) is the diameter (d ｓ 47. The system of claim 46, wherein the

48. The inner surface of the lid faces the bottom wall and has a length (l ｈｖ ) and the distance (l ｌｂ 48. The system of claim 44, wherein the lid is spaced apart by a distance of 1 mm to prevent longitudinal movement of the bioprosthetic heart valve within the valve housing when the lid is in the closed position.

49. The lid inner surface comprises a cylindrical lid cavity shaped to accommodate an upper portion of the biological heart valve, and the diameter (d ｌｃ ) is the diameter (d ｓ ) or the diameter (d ｈｖ 49. The system of claim 48, wherein the

50. 50. The system of any of claims 28 to 49, wherein the valve housing further comprises indicia identifying the biological heart valve.

51. 51. The system of claim 50, wherein the indicia are provided on one or both of the lid and the bottom wall.

52. 52. The system of claim 51, wherein the indicia indicate the size of the bioprosthetic heart valve, and the indicia are thermoformed onto the lid and the bottom wall.

53. 53. The system of any of claims 28-52, wherein the bioprosthetic heart valve is secured within the opposing surfaces of the inner wall by frictional engagement between the side wall and fabric.

54. 54. The system of claim 53, wherein the bioprosthetic heart valve is not physically attached, secured, or embedded within the valve housing.

55. The valve housing further comprises an outer wall, and a distance (l) between opposing surfaces of the outer wall ｏｓ ) is the distance (l) between the opposing surfaces of the inner wall ｉｗ 55. The system of claim 54, wherein the outer wall has an opposing surface that does not contact the biological heart valve.

56. A system according to any one of claims 28 to 55, wherein the valve housing is formed from a single, integral piece of material.

57. A system according to any of claims 28 to 55, wherein the valve housing does not include separate parts physically joined together.

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