System for dry storage of bioprosthetic heart valves

Abstract

The present application relates to a system for dry storage of bioprosthetic heart valves. A system for dry storage of a bioprosthetic heart valve includes a valve housing and a storage tray. The valve housing has a cavity sized to retain the heart valve and permit addition of hydrated liquid prior to implantation. A cover is pivotally movable between an open position and a closed position (to enclose the heart valve within the valve housing. The valve housing cavity is sized to inhibit rotation and lateral movement of the bioprosthetic heart valve. The valve shell is nested within a storage tray and a mating surface upwardly positions the valve shell in a particular position and helps to prevent rotational movement of the valve shell relative to the storage tray. The storage tray has a gas permeable membrane, and the valve housing has an aperture to permit passage of a sterilization gas.

Description

Technical Field

[0001] The present disclosure relates to packaging for medical devices, and more particularly, to a method and system for dry packaging a bioprosthetic valve without a liquid sterilant solution. Background Art

[0002] The packaging of bioprosthetic heart valves has presented a number of challenges. Bioprosthetic heart valves are conventionally packaged in bottles filled with a preservation solution for shipping and storage prior to use in the operating room. In order to minimize the possibility of damage to the relatively fragile bioprosthetic heart valve, it is stabilized with a bracket structure to prevent contact with the interior of the bottle.

[0003] Prior to implantation in a patient, the valve is removed from the bottle and then rinsed with a stream of liquid, or submerged and agitated in a bath. Surgical prosthetic valves typically have a valve retainer located at their center and sewn thereto, and retainers for both, the inflow sewing ring for the mitral valve and the outflow commissure tips for the aortic valve, attached to the proximal end of the valve, with an attached surgical delivery handle attached thereto extending proximally away from the implantation site.

[0004] Glutaraldehyde is widely used as a storage solution due to its sterilizing properties, but can contribute to calcification. Certain strategies to reduce the glutaraldehyde content in the final product have been shown to reduce calcification in vivo.

[0005] One such strategy dehydrates the bioprosthetic tissue in a glycerol / ethanol mixture, sterilizes with ethylene oxide, and "dry" packages the final product. This process circumvents the potential toxicity and calcific effects of glutaraldehyde as a sterilant and storage solution. Since the dehydrated prosthetic heart valve can absorb ambient moisture, a moisture barrier packaging system can be used.

[0006] Several methods have been proposed herein to use glycerol, alcohols, polyols, sugars, sugar alcohols, hydrophilic polymers, and combinations thereof as post-glutaraldehyde treatment agents so that the resulting tissue is in a dehydrated or "dry" state rather than a wet state stored in excess glutaraldehyde. These methods avoid the use of aqueous liquid aldehydes or liquid sterilants as storage solutions for tissues and devices. Glycerol-based methods can be used for such storage systems. In addition, U.S. Publication No. US2001 / 0023372A1 describes the use of polyols such as glycerol to treat bioprosthetic tissues.

[0007] In light of the development of dehydrated tissue heart valves, the opportunity to create alternative packaging for such valves would provide a combination of moisture barrier, cost reduction, and simplified field deployment. Summary of the invention

[0008] The present disclosure relates to packaging for medical devices, and more particularly, to a method and system for dry packaging a bioprosthetic heart valve.

[0009] In one example, a system for dry storage of a bioprosthetic heart valve includes a valve housing sized to removably retain the bioprosthetic heart valve. The bioprosthetic heart valve may include a stent having a diameter d s A stent and a compressible fabric covering a portion of an outer surface of the stent, wherein the covered portion has a diameter greater than the stent diameter d s 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 side wall. The cavity may be sized to accommodate a bioprosthetic heart valve and retain a liquid for hydrating the bioprosthetic heart valve prior to implantation in a patient.

[0010] At least a portion of the opposing surface of the inner sidewall can be configured to contact the bioprosthetic heart valve when the bioprosthetic heart valve is positioned within the cavity. Rotational and lateral movement of the bioprosthetic heart valve within the cavity can be inhibited by contact between the opposing surface and the bioprosthetic heart valve. In one aspect, the opposing surfaces of the inner sidewall can be spaced apart to compress only the compressible fabric of the bioprosthetic heart valve and not the stent. According to this aspect, the diameter d of the stent is s Can remain largely unchanged.

[0011] A lid may be provided to close the upper cavity opening. The lid may be pivotally movable between an open position and a closed position. In the open position, the lid is 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 example, the lid may be pivotally movable between an open position exposing the upper cavity opening and a closed position covering the upper cavity opening.

[0012] In the closed position, the inner surface of the cover may face the bottom wall and may be aligned with the length l of the bioprosthetic heart valve. hv Roughly the same distance l lb The spacing is to inhibit the bioprosthetic heart valve from moving along the longitudinal axis of the bioprosthetic heart valve within the valve housing. According to one aspect, if the distance l between the inner surface of the cover and the bottom wall is lb Not slightly greater than the length of the bioprosthetic heart valve l hv , then the distance between the inner surface of the lid and the bottom wall is the same when the lid is in the closed position.

[0013] The lid may further include a plurality of undulations around its periphery. In the closed position, the plurality of undulations may allow sterilizing gas to enter the cavity. According to one aspect, the plurality of undulations may be formed by one or both of the lid periphery and the cavity lid. Thus, when the lid is in the closed position, at least a portion of the lid periphery and at least a portion of the cavity lip surrounding the upper cavity may be combined together so that the plurality of undulations may form an aperture in the cavity.

[0014] According to one aspect, the valve housing can further include an outer sidewall spaced apart from the inner sidewall.The outer sidewall can provide an increased cavity volume to retain liquid for hydrating the bioprosthetic heart valve.

[0015] In an example, the system may further include a storage tray in which the valve cavity can be nested. The storage tray may include an upper tray opening and a microbial barrier membrane. The storage tray may be configured to receive and enclose the valve housing through the upper tray opening, and may enclose the valve housing when the microbial barrier membrane is fastened to a tray lip surrounding the upper tray opening.

[0016] According to one aspect, the storage tray may be formed from a single unitary piece of material.

[0017] According to another aspect, the storage tray does not include separate components that are physically joined together.

[0018] According to another aspect, the valve housing may be completely nested within the storage tray and the microbial barrier membrane.

[0019] According to another aspect, the microbial barrier membrane may be permeable to the sterilizing gas.

[0020] According to another aspect, the storage tray and valve housing may be shaped to inhibit rotational movement of the valve housing relative to the storage tray when the valve housing is enclosed within the storage tray.

[0021] According to another aspect, the storage tray and the valve housing may each include mating surfaces configured to contact when the valve housing is placed in the storage tray. The mating surfaces may be shaped or configured to inhibit rotation and lateral movement of the valve housing in the storage tray.

[0022] According to another aspect, the mating surfaces do not inhibit movement of the valve housing from the storage tray out of the upper tray opening.

[0023] According to another aspect, the mating surface can be configured to position the valve housing in a particular orientation relative to the storage tray. In one aspect, the housing mating surface is configured to permit the valve housing to be nested within the storage tray in one orientation.

[0024] According to another aspect, the mating surfaces engage one another without friction.

[0025] According to another aspect, the mating surface may include a male key formed by one of the valve housing and the storage tray, and a female key formed by the other of the valve housing and the storage tray.

[0026] According to another aspect, the female key may be formed as a U-shaped channel in the storage tray. The U-shaped channel may include an open end, a closed end, and a channel width w between the open end and the closed end. f According to another aspect, the male key may be formed as a protrusion on the valve housing that fits within the U-shaped channel. The protrusion may have a width smaller than the channel width w f The protrusion width w p The term "U-shape" may include shapes, and the shapes include V-shape, T-shape, W-shape, and other shapes that permit keying.

[0027] According to another aspect, the open end of the U-shaped channel may face the upper tray opening so that when the microbial barrier membrane is removed from the storage tray, inverting the storage tray causes the valve housing to fall from the storage tray.

[0028] According to another aspect, the storage tray may further include one or more finger retainers formed from an outer surface of the storage tray.The finger retainers may further include a grip enhancing ridge.

[0029] According to another aspect, the storage tray may include inner tray sidewalls to secure the valve housing. The storage tray may further include outer tray sidewalls that may be spaced far enough 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 the tray lip.

[0030] According to another aspect, the system can further include a moisture barrier container configured to receive the storage tray and the valve housing retained therein. In one aspect, the moisture barrier material can also be impermeable to moisture and gas.

[0031] According to another aspect, the system can further include an outer container configured to receive the moisture barrier container containing the storage tray and the valve housing retained 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.

[0032] According to one aspect, the outer container may include an RFID tag and a buffer to reduce signal interference.

[0033] According to another aspect, the system may include a temperature sensor and a temperature indicator. The temperature indicator may display a signal when an enclosed space in the packaging assembly or a component in the packaging assembly has experienced a temperature outside a predetermined temperature range. According to one aspect, the temperature sensor and the temperature indicator may be disposed within the outer container.

[0034] According to another aspect, the system may include a relative humidity sensor and a relative humidity indicator. The relative humidity indicator may display a signal when the relative humidity within the packaging assembly or the relative humidity within the enclosed space in the components of the packaging assembly exceeds a predetermined relative humidity range. According to one aspect, the relative humidity sensor and the relative humidity indicator may be disposed within a moisture barrier container.

[0035] According to another aspect, the system can further include a label having instructions that allow for aseptic transfer of the bioprosthetic heart valve into a sterile field of an operating room by identifying sterile and non-sterile contents.

[0036] Each of the features or concepts summarized above is independent and can be combined with other features or concepts summarized above or with any other features or concepts disclosed in this application.

[0037] In another example, a system for dry storage of a bioprosthetic heart valve is provided. The system may include a valve housing sized to removably retain a bioprosthetic heart valve. The valve housing may include a cavity sized to accommodate the bioprosthetic heart valve and retain a liquid for hydrating the bioprosthetic heart valve prior to implantation in a patient. When the bioprosthetic heart valve is positioned within the cavity, the cavity may include an upper cavity opening, a bottom wall, and an inner sidewall that contacts the bioprosthetic heart valve. The inner sidewall may inhibit rotation and lateral movement of the bioprosthetic heart valve within the cavity.

[0038] The lid may be fastened to the upper cavity opening. The lid may include a lid inner surface that faces the bottom wall of the cavity when the lid is in the closed position. The lid may be pivotally movable between an open position and a closed position.

[0039] One or more apertures may be provided to permit sterilizing gas to enter the cavity when the lid is in the closed position.

[0040] According to one aspect, the valve housing is completely formed by a forming method. The forming method may be one or more selected from the group consisting of: thermoforming, injection molding, blow molding, machining and 3D printing.

[0041] According to one aspect, the forming method is thermoforming.

[0042] According to one aspect, the valve housing is made of a material consisting of: a thermoformed plastic. The thermoformed plastic may be polyethylene terephthalate.

[0043] According to one aspect, the valve housing can be formed from a single unitary piece of material, rather than being constructed by joining separate pieces of material. In one aspect, the valve housing does not include separate parts that are joined together.

[0044] According to one aspect, the valve housing may further include a cavity lip formed around the upper cavity opening, and the cover may be frictionally secured to the cavity lip.

[0045] According to one aspect, the valve housing may further include first and second offset tabs configured to allow a user to open the lid from the closed position to the open position with one hand. The first offset tab may be formed by the lid and the second offset tab may be formed by the cavity lip.

[0046] According to another aspect, one or more apertures can be formed as one or more gaps between the cover and the cavity lip.In one aspect, the apertures can be created by a forming process without punching or otherwise removing material from the valve housing.

[0047] According to another aspect, the lid may include a lid periphery having a first set of undulations, and the cavity lip may include a second set of undulations. When the lid is in a closed position, the first set of undulations and the second set of undulations may meet to form one or more apertures.

[0048] According to another aspect, the valve housing may include a living hinge between the cavity and the cover.

[0049] According to another aspect, a bioprosthetic heart valve may include a stent and an outer surface. The stent may be made of metal or a metal alloy, and the outer surface may be a fabric. The fabric may surround at least a portion of the stent, and the fabric may have a loft that permits radial compression of the bioprosthetic heart valve. In one aspect, the fabric may surround a portion of the stent. In another aspect, the fabric may surround the entire stent.

[0050] According to another aspect, the inner sidewall of the cavity can be sized such that opposing surfaces of the inner sidewall can compress the bioprosthetic heart valve to removably retain the bioprosthetic heart valve within the cavity.

[0051] According to another aspect, the opposing surface of the inner side wall may compress only the fabric of the bioprosthetic heart valve and not the stent.

[0052] According to another aspect, the diameter d of the bioprosthetic heart valve hv The distance l between the opposite surface of the inner wall iw Basically the same.

[0053] According to another aspect, the distance l between the opposing surfaces of the inner side wall iw Can be smaller than the diameter d of a bioprosthetic heart valve hv .

[0054] According to another aspect, the distance l between the opposing surfaces of the inner side wall iw Can be larger than the diameter d of the stent sAccording to another aspect, the distance l between the opposing surfaces of the inner side wall is iw Can be smaller than the diameter d of a bioprosthetic heart valve hv and is larger than the diameter d of the stent s .

[0055] According to another aspect, the inner surface of the cover can face the bottom wall and can be aligned with the length l of the bioprosthetic heart valve. hv The caps are spaced substantially the same distance apart to inhibit longitudinal movement of the bioprosthetic heart valve within the valve housing when the cap is in the closed position.

[0056] According to another aspect, the inner surface of the cap may include a cylindrical cap 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 in the valve holder. The diameter d of the cylindrical cap cavity is lc Can be larger than the diameter d of the stent s or the diameter of the bioprosthetic heart valve d hv .

[0057] According to another aspect, the valve housing may further include a marking identifying the bioprosthetic heart valve. The marking may be disposed on one or both of the cover and the bottom wall. The marking may indicate the size of the bioprosthetic heart valve. The marking may be thermoformed on the cover and the bottom wall.

[0058] According to another aspect, a bioprosthetic heart valve can be secured within opposing surfaces of the inner sidewall by frictional engagement between the inner sidewall and the fabric.

[0059] According to another aspect, the bioprosthetic heart valve is not physically attached, secured, or snapped into the valve housing.

[0060] According to another aspect, the valve housing may further include an outer wall. The distance between opposing surfaces of the outer wall may be greater than the distance between opposing surfaces of the inner wall. The opposing surfaces of the outer wall do not contact the bioprosthetic heart valve.

[0061] Each of the features or concepts summarized above is independent and can be combined with other features or concepts summarized above or with any other features or concepts disclosed in this application.

[0062] Examples of packaging systems do not include a holder or housing to which the valve is mechanically fastened, connected or attached, such as using sutures, one or more clips, or another mechanical fastener.

[0063] Examples of packaging systems generally do not include sterilizing agents in the final product.

[0064] Various features as described elsewhere in this disclosure may be included in the examples summarized herein, and various methods and steps for using the examples and features may be used, including as described elsewhere herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Figure 1 is an exploded perspective view of a storage system and includes a microbial barrier membrane, a bioprosthetic heart valve, a valve housing, and an open storage tray.

[0066] Figure 2A An exploded perspective view of an example of an open storage tray and a microbial barrier membrane.

[0067] Figure 2B for Figure 2A A top plan view of an open storage tray.

[0068] Figure 2C For Figure 2A The view indicated in FIG. 1 is a side view of an open storage tray.

[0069] Figure 2D For Figure 2A The view indicated in FIG. 1 is a side view of an open storage tray.

[0070] Figure 3A is a perspective view of an example of a valve housing with a cover in a closed position.

[0071] Figure 3B for Figure 3A A perspective view of a valve housing with a cover in an open position.

[0072] Figure 3C for Figure 3A Top view of the valve housing with the cover in the open position.

[0073] Figure 3D for Figure 3A has from Figure 3A The view indicated in FIG. 8 is a side view of the valve housing of the cover in the closed position.

[0074] Figure 4A is a perspective view of an exemplary bioprosthetic valve.

[0075] Figure 4B for Figure 4A Side view of a bioprosthetic valve.

[0076] Figure 5A for Figure 4A A perspective view of a bioprosthetic heart valve positioned within a valve housing.

[0077] Figure 5B For along Figure 3A 5B-5B is a cross-sectional view of the valve housing.

[0078] Fig. 6A for Figure 3B Nested in Figure 2A A perspective view of the valve housing within the storage tray.

[0079] Figure 6B For along Fig. 6A 6B-6B is a cross-sectional view of the valve housing and bioprosthetic valve assembly.

[0080] Figure 7 is a perspective view of an exemplary tear-away moisture barrier container.

[0081] Figure 8 is a perspective view of an exemplary package with a sensor, a marker, and an indicator. DETAILED DESCRIPTION

[0082] The packaging system 100 is Figure 1 1 and 2 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 retain a bioprosthetic heart valve 10. Each of these components will be described in more detail with reference to the following figures.

[0083] Storage tray 200 Figure 1 and Figures 2A to 2D 200. The storage tray 200 includes an open cavity 202 defined by a bottom 204, outer tray sidewalls 225, and an upper tray opening 210. The upper tray opening 210 terminates at a surrounding tray lip 212. The 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 apart and configured to accommodate a valve housing 300. A separate microbial barrier membrane 250 may be attached to the tray lip 212 to completely enclose the valve housing 300 within the cavity 202. The storage tray 200 may additionally be provided with grip enhancement ridges 231 disposed on the sides of the formed finger retainers 221 to enhance a user's grip on the storage tray 200.

[0084] The valve housing 300 is Figures 3A to 3D and FIG. 5A to FIG. 5B The valve housing 300 includes a valve body that can be in a closed position ( Figure 3A ) and the open position ( Figure 3B) and a cap 350. Cavity 340 includes an inner sidewall 320 and a bottom wall 330 defining a valve space within which bioprosthetic heart valve 10 may be retained. An outer sidewall 325 may be spaced apart from inner sidewall 320 and may provide additional cavity volume to accommodate hydration liquid. The additional cavity volume provided by outer sidewall 325 may be in fluid communication with the valve space so that the hydration liquid may immerse the bioprosthetic heart valve 10.

[0085] A cover 350 may be provided to cover the upper cavity opening 310 and enclose the bioprosthetic heart valve 10 within the cavity 340. The cover 350 may be pivotally connected to the cavity 340 via a hinge 360 ​​and may include a cover inner surface 356 centrally located on the cover 350. The cover 350 may be frictionally secured to the cavity lip 312.

[0086] In one example, hinge 314 is a movable or flexible hinge including one or more bends, such as Figure 3B and Figure 5A Depicted. Providing a living hinge 314 allows the cover 350, hinge 314, and cavity 340 to be molded or formed from the same material as a single, unitary piece without the need to join or physically attach separate components. Other examples of hinges include living hinges that do not include any bends. In other examples, the cover and cavity of the valve housing are manufactured as separate components.

[0087] A pair of tabs 395A, 395B may further be provided to allow a user to separate the cover 350 from the cavity 340. FIG. 3A to FIG. 3C In the example depicted in , one tab 395A can be formed by and extend from the cavity lip 312, and the other tab 395B can be formed by and extend from the lid periphery 355. The tabs 395A, 395B can be offset from each other to permit one-handed opening of the lid 350. In one approach, two fingers can apply opposing pressure to the tabs 395A, 395B to separate them.

[0088] Notably, the example of packaging system 100 does not include a holder or housing to which bioprosthetic valve 10 is mechanically fastened, connected, or attached, for example, using sutures, one or more clips, or another mechanical fastener. Omitting these features can reduce costs by eliminating manufacturing steps, particularly manual steps, and reducing part count, as well as improving the end-user experience by eliminating the step of separating the valve from the holder.

[0089] Although packaging system 100 is depicted as housing bioprosthetic heart valve 10, it should be understood that packaging system 100 may be sized and adapted to house other implantable medical devices requiring dry and sterile storage conditions.

[0090] The term "drying" as used herein does not exclude the presence of any water or moisture (including liquid water) in or on the surface of a package or bioprosthetic valve. For example, some bioprosthetic valves include tissues in which water is an inherent component, in which case complete elimination of water is not desirable. In addition, some manufacturing steps may include at least some water, such as sterilization by ethylene oxide or propylene oxide. Droplets of water may also be present as condensate, especially at lower temperatures.

[0091] In the exemplary example, packaging system 100 may be used to store bioprosthetic heart valve 10 . FIG. 4A to FIG. 4B A bioprosthetic heart valve 10 is depicted, the bioprosthetic heart valve 10 comprising a stent or having a stent diameter d s and the length l between the inflow end 13 and the outflow end 15 hv The frame 12 of the stent 12. The valve structure 14 is fastened to the inner surface of the stent 12, and the fabric 18 surrounds at least a portion of the outer surface of the stent 12 at the inflow end 13. The bioprosthetic heart valve 10 can appear in various sizes. For a bioprosthetic heart valve 10 intended for implantation in a patient's valve annulus, the bioprosthetic heart valve 10 can appear in various diameters (e.g., 20 mm, 23 mm, 26 mm, and 29 mm). Therefore, an appropriate bioprosthetic heart valve 10 can be selected based on the measured size of the patient's valve annulus.

[0092] In one example, the fabric 18 can have a thickness, loft, nap, or pile such that the fabric 18 is compressible. The diameter d of the heart valve hv reflects the diameter as measured from the widest part of the bioprosthetic heart valve including the thickness of the fabric. Thus, the diameter of the heart valve, d hv will necessarily be larger than the stent diameter d obtained at the same location of the bioprosthetic heart valve 10 s US Patent No. 11,123,184 is incorporated herein by reference in its entirety as if fully set forth herein. Other examples of bioprosthetic heart valves have different structures, such as one or more of a different stent structure or a different fabric structure.

[0093] The components of packaging system 100 are designed to maintain the integrity of bioprosthetic heart valve 10 during storage and transport. To this end, various features of valve housing 300 and storage tray 200 are configured and dimensioned to reduce or inhibit lateral movement (x-axis), longitudinal movement (y-axis), and / or rotational movement r about the y-axis of bioprosthetic heart valve 10 relative to valve housing 300 and storage tray 200 during transport. Figure 1 .

[0094] In one example, opposing surfaces of the inner sidewall 320 of the valve housing 300 can be sized and configured to help stabilize the bioprosthetic heart valve 10 .

[0095] According to this example, at least a portion of the opposite surface of the inner side wall 320 may be spaced apart by a distance l. iw The distance is approximately equal to or greater than the diameter d of the stent 12. s , but smaller than the diameter d of the heart valve 10 hv :d hv > iw ≥d s .

[0096] When configured accordingly, the opposing surfaces of the inner sidewall 320 can compress the bioprosthetic heart valve 10 and the compression fabric 18 can provide sufficient friction to inhibit lateral, longitudinal, and / or rotational movement of the bioprosthetic heart valve 10 within the valve housing 300 .

[0097] Although the portions of the opposing surfaces of the inner side wall 320 are separated by a distance l iw The bioprosthetic heart valve 10 is permitted to be frictionally retained between the opposing surfaces of the inner sidewall 320, but this frictional retention is not so great that the bioprosthetic heart valve 10 cannot or is difficult to manually remove.

[0098] In one example, the distance l is selected iw , so that only the fabric 18 is compressed to reduce the diameter d to which the compression is applied hv , but the stent is not compressed, so that the diameter of the stent d s This friction retention can be sufficient to inhibit lateral and rotational movement of the bioprosthetic heart valve 10 within the valve housing 300 without permanently deforming structural components (e.g., the stent 12) of the bioprosthetic heart valve 10. In other words, the friction retention is tuned to retain the bioprosthetic heart valve 10 without permanently or adversely changing or affecting the structural integrity of the stent 12.

[0099] In some examples, the portion of the inner sidewall 320 that contacts the bioprosthetic heart valve 10 can be deformed sufficiently to expand slightly upon insertion thereof, thereby frictionally engaging the bioprosthetic heart valve 10 without deforming or otherwise damaging the heart valve. Such a feature is desirable, for example, where the heart valve 10 includes a portion that does not have fabric that contacts the inner sidewall.

[0100] It should be understood that this friction retention of the bioprosthetic heart valve 10 provided by the opposing surface of the inner wall 320 can be achieved in a variety of ways. For example, the opposing surface of the inner wall 320 can be separated from the bottom wall 330 toward the cavity opening 310 along its entire height by a distance l. iw .

[0101] Alternatively, only portions of the opposing surfaces of the inner sidewall 320 may be separated by a distance l. iw , as may be the case where the distance between portions of the opposing surfaces of the inner side wall 320 is narrowed.

[0102] In another alternative, the opposing surfaces of the inner side wall may be separated by a distance l in a portion of the inner side wall 320. iw , where the remainder expands to define a distance greater than l iw Expanding the opposing surfaces of the inner sidewall 320 toward the cavity opening 310 can facilitate removal of the bioprosthetic heart valve 10 .

[0103] although Figure 3B to Figure 3D The example depicted in illustrative figures depicts the inner sidewall 320 as having two separate opposing walls 320A, 320B, but it should be understood that the inner sidewall 320 may be configured as a single continuous wall.

[0104] The valve housing 300 can be further dimensioned to inhibit or limit longitudinal movement of the bioprosthetic heart valve 10 within the valve housing 300. In one example, the cover 350 can be configured such that the distance l between the cover inner surface 356 and the bottom wall 330 is 1:1 when the cover 350 is in the closed position. lb The length l of the bioprosthetic heart valve 10 hv Basically the same.

[0105] In one example, the cap 350 can further include a raised edge 354 extending beyond and around the cap inner surface 356 such that a recessed cap cavity 358 is defined to receive one end of the bioprosthetic heart valve 10 (eg, the inflow end 13 or the outflow end 15 ).

[0106] In one aspect of this example, 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 Slightly larger than the length l of the bioprosthetic heart valve 10 hv .

[0107] In one example, the recessed cavity 358 defined by the raised edge 354 accommodates the end not covered by the fabric and may have a diameter d of about the same as the diameter of the stent 12. s Approximately the same diameter d lc In another example, the recessed cavity 358 defined by the raised edge 354 accommodates the fabric-covered tip and thus may have a diameter d of the bioprosthetic heart valve 10. hv Approximately the same diameter d lc The concave cavity 358 has a slightly larger diameter d than the distal end of the bioprosthetic heart valve 10 received in the concave cavity 358. lcThe likelihood that the raised edge 354 will contact the bioprosthetic heart valve 10 is reduced because the cover 350 is moved from the open position ( Figure 3B ) and closed position ( Figure 3A At the same time, the raised edge 354 provides another structure that can inhibit or limit the lateral movement of the bioprosthetic heart valve 10 within the valve housing 300.

[0108] Because valve housing 300 provides a sterile seal for bioprosthetic heart valve 10, valve housing 300 may include one or more apertures 390 to allow for the cap 350 to be in a closed position ( Figure 3A ) allows sterilizing gas to enter cavity 340.

[0109] In one example, one or more apertures 390 are formed when the cover 350 is secured to the cavity lip 312. Figure 3A and Figure 3B In the example depicted in FIG. 1 , the cavity lip 312 of the valve housing 300 may include an indentation or relief 390A that is formed when the lid 350 is in the closed position ( Figures 3A to 3D and Figure 5A ) when the indentation or relief 390A is bent away from the lid 350. The lid periphery 355 includes a correspondingly positioned curved indentation or relief 390B when the lid 350 is in the closed position ( Figure 3B ) when the indentation or undulation 390B bends away from the cavity 340. When the cap 350 is fastened to the cavity lip 312, the indentations or undulations 390A, 390B meet to form an aperture or passage 390 through which the sterilizing gas can enter the cavity 340.

[0110] In one example, the indentations or undulations 390A, 390B may be produced by thermoforming. In another example, one or more apertures 390 are not produced in the valve housing 300 by stamping, cutting, or otherwise removing material of the valve housing 300, an operation that may produce undesirable particles. Thus, according to this example, the valve housing 300 does not include any apertures or features caused by removing material from the valve housing 300.

[0111] Other examples of valve housings do not include apertures, such as where a sterilizing gas is not used in the manufacturing process, such as sterilization by radiation, electron beam, gamma radiation, ultraviolet radiation, microwave radiation, plasma, heat, steam, or liquid sterilants.

[0112] Although the valve housing 300 is configured to provide secure retention of the bioprosthetic heart valve 10 , the valve housing 300 may be shaped and configured to be securely retained within the storage tray 200 .

[0113] FIG. 6A to FIG. 6BDepicted is a valve housing 300 positioned within a storage tray 200. The inner tray sidewall 220 of the storage tray 200 and the facing outer surface 327 of the outer sidewall 325 of the valve housing 300 are sized, configured, and / or shaped to inhibit or limit rotational movement of the valve housing 300 relative to the storage tray 200. This feature is advantageous in providing another stabilizing feature for the bioprosthetic heart valve 10.

[0114] like FIG. 6A to FIG. 6B As depicted in the figure, the valve housing 300 can be configured to be completely nested within the storage tray 200. In one example, the valve housing 300 can be sized to be nested within the valve housing retaining space 222 disposed between opposing surfaces of the inner tray sidewall 220. In one aspect, the inner tray sidewall 220 partially surrounds the valve housing 300, as depicted in the figure. In another aspect, the inner tray sidewall completely surrounds the valve housing 300.

[0115] In one example, the valve housing 300 has a curved outer wall surface 327. The inner tray sidewall 220 may be provided in a corresponding curved shape to face the opposite side of the outer wall surface 327 of the valve housing 300.

[0116] It may be desirable for the packaging system 100 to have one or more features that inhibit or reduce longitudinal, lateral, and / or rotational movement of the valve housing 300 relative to the storage tray 200 during shipping.

[0117] In one example, the inner tray sidewall 220 may be formed to at least partially conform to the contour of the outer wall surface 327 to reduce, limit or inhibit lateral movement of the valve housing 300 relative to the storage tray 200. It should be 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, if the gap is small enough, lateral movement may be inhibited. In one example, lateral movement is inhibited as long as the gap between the facing 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 in a range including any two of the foregoing values ​​and between any two of the foregoing values. Thus, for example, the gap between the facing surface of the inner tray sidewall 220 and the outer wall surface 327 may be about 3 mm or less.

[0118] In another example, portions of the inner tray sidewall 220 and the facing outer wall surface 327 can be in physical or frictional contact with each other 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 provided within a range including and between any two of the foregoing values.

[0119] In another example, the inner tray sidewall 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 sidewall 220 and the valve housing 300. According to this example, the valve housing 300 can be disengaged from or removed from the storage tray 200 by simply inverting the storage tray 200. For example, the storage tray 200 can be inverted and the valve housing 300 can be allowed to simply fall out of the upper tray opening 210 and onto a receiving hand or surface in the sterile field. This minimizes the risk of physical contact with the non-sterile portion of the storage tray 200 during the aseptic transfer of the bioprosthetic heart valve 10 to the sterile field. According to this example, no frictional contact is provided between the storage tray 200 and the valve housing 300, and therefore no force is required to remove the valve housing 300 from the storage tray 200.

[0120] In one example, longitudinal movement of the valve housing 300 relative to the storage tray 200 can be further inhibited by relying on certain structural features of the storage tray 200. In one example, the storage tray 200 can be sized such that the microbial barrier membrane 250 is disposed on the tray lip 212 proximate to or in contact with the lid 350 of the valve housing 300. According to this example, when the microbial barrier membrane 250 is attached to the tray lip 212, the microbial barrier membrane 250 can be spaced apart 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 example, the microbial barrier membrane 250 can be in contact with the lid 350 of the valve housing 300. In another example, the storage tray 200 may include tabs or protrusions that contact or interact with the valve housing 300 to inhibit or limit longitudinal movement of the valve housing when the microbial barrier membrane 250 is assembled on the storage tray 200 .

[0121] The microbial barrier membrane 250 can be made of a material that can create a microbial barrier. One suitable gas permeable material can be a thin sheet of high-density polyethylene fibers that is difficult to tear 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 non-woven material, such as a non-woven polyethylene fiber (e.g., Spunbond polyethylene, DuPont). A hot melt adhesive may be used to secure the microbial barrier film 250 to the tray lip 212.

[0122] The microbial barrier film 250 can be adhered to the tray lip 212 with an adhesive. Suitable adhesives may include hot melt adhesives, pressure seal adhesives, or heat seal adhesives. The microbial barrier film 250 can be made of a breathable or gas permeable material to provide gas sterilization of the contents sealed in the storage tray 200. One suitable gas permeable material is a high density polyethylene fiber sheet that is difficult to tear but can be easily cut with scissors. In one example, the microbial barrier film, while permeable to gas, is impermeable to liquid water.

[0123] The rotational movement of the valve housing 300 relative to the storage tray 200 may also be inhibited or limited. This may be accomplished by providing a mating keying pair including a male key and a female key. In one example, the storage tray 200 may include one of the male key or the female key, and the valve housing 300 may include the other of the male key or the female key. This keying feature eliminates six degrees of freedom (three translations and three rotations) between the valve housing and the storage tray, thereby reducing "clicks" and product shifting that may simplify quality control, facilitate validation, and facilitate regulatory approval uncertainty, as well as eliminating the risk of causing the end user to perceive poor quality.

[0124] exist Figure 1 , Figure 2A and Figure 2B , Figures 3A to 3D , Figure 5B and Figure 6B In the example shown, the storage tray 200 is depicted as including a female key 280, and the valve housing 300 is depicted as including a male key 380. It should be understood that the assignment of a male key or a female key to the storage tray 200 or the valve housing 300 can be reversed, such that the valve housing 300 can include a female key 280 and the storage tray 200 can include a male key 380. The example shown includes one set of keys between the storage tray and the valve housing. Other examples can include two or more sets of keys.

[0125] In one example, the female key 280 is thermoformed from the storage tray 200 and the male key 380 is thermoformed from the valve housing 300. In one example, the mating keying pair 280, 380 can frictionally fit with close tolerances between the surfaces of the female key 280 and the male key 380. In this example, there is little to no rotational movement of the valve housing 300 relative to the storage tray 200.

[0126] In another example, the engagement of the mating keying pair can be configured to not interfere with the removal of the valve housing 300 from the storage tray 200. As previously described, it may be desirable for the valve housing 300 to fall out of the storage tray 200 without assistance when the open end of the storage tray 200 is inverted. Thus, in one example, the female key 280 can 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 can be formed as a protrusion that fits within the female key 280, preferably without friction.

[0127] In another example, the facing surfaces of the female key 280 and the male key 380 can be fitted so that there is a small gap between the two surfaces. The small gap facilitates removal of the valve housing 300 from the storage tray 200 while inhibiting significant rotational movement of the valve housing 300 within the storage tray 200.

[0128] In one example, the gap between the two facing surfaces of the female key 280 and the male key 380 is about 5 mm or less, about 4 mm or less, about 3 mm or less, about 2 mm, or about 1 mm or less.

[0129] In another example, if the valve housing 300 is centered about the y-axis ( Figure 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 any two of the foregoing values ​​and between any two of the foregoing values, then rotational movement of the valve housing 300 relative to the storage tray 200 is inhibited.

[0130] In one example, the storage tray 200 may include an outer tray sidewall 225 that is spaced apart from the inner tray sidewall 220. Figures 2A to 2D In the example depicted in FIG. 2 , the outer tray sidewall 225 terminates at the tray lip 212 and is sufficiently spaced apart from the opposing surface of the inner tray sidewall 220 to permit a user to grasp the upper peripheral edge 301 of the valve housing, such as FIG. 6A to FIG. 6B shown in.

[0131] As previously mentioned, in one example, the tray lip 212 is positioned at a sufficient distance from the inner tray sidewall 220 so that a user's fingers can grasp the valve housing 300 present in the valve housing retaining space 222 without the fingers contacting 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.

[0132] In one example, one or both of the storage tray 200 and the valve housing 300 can be completely thermoformed from a single material. In one example, the thermoformed material can 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 copolymer (ABS), and blends thereof. In a preferred example, one or both of the storage tray 200 and the valve housing 300 are the same material, such as PETG. Making the two components from the same material can improve the recyclability of the packaging system. The thermoformed material can be completely opaque, semi-opaque, or transparent. In a preferred example, the thermoformed material is transparent to permit observation of the valve housing 300 contained in the valve housing retaining space 222.

[0133] In one example, one or both of the storage tray 200 and the valve housing 300 may be made of a transparent material. This permits observation of the bioprosthetic heart valve 10 and the valve housing 300 before removing the microbial barrier membrane 250 of the storage tray 200. In one example, the identification mark 399 may be disposed on one or both of the lid 350 and the bottom wall 330 of the valve housing 300. Since the storage tray 200 is transparent, the identification mark 399 will be visible without removing the microbial barrier membrane 250 of the storage tray 200. Figure 1 and Figures 3A to 3D As shown in , the identification mark can be any information about the characteristics of the bioprosthetic heart valve 10 , such as the size and / or model of the bioprosthetic heart valve 10 .

[0134] In one example, the packaging system 100 is assembled by placing the bioprosthetic heart valve 10 between the opposing surfaces of the inner side wall 320 of the valve housing 300 and the closing 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 so that the male key 380 associated with the valve housing 300 is positioned inside the female key 280 associated with the storage tray 200. The microbial barrier membrane 250 is fastened to the storage tray 200 using a suitable adhesive and the packaging system 100 to enclose the valve housing 300 and the bioprosthetic heart valve 10, and the assembled packaging system undergoes 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, heat. In one example, the sterilization is gas sterilization, and more specifically, sterilization by ethylene oxide. The sterilization method selected preferably does not produce hazardous and toxic by-products.

[0135] Examples of packaging system 100 generally do not contain residual sterilants or terminal sterilants in the end-user product. The bioprosthetic valve 10 is sterilized using a non-permanent sterilant or sterilization method, and the sterility is maintained by the packaging system. Therefore, the end user is not exposed to residual sterilants or terminal sterilants when the bioprosthetic valve 10 is removed from the packaging system 100, thereby reducing potential exposure to hazardous substances and reducing the use of such substances throughout the supply chain.

[0136] In one example, the assembled packaging system can be further packaged inside a moisture barrier container 60. The moisture barrier container 60 can be made of any suitable material that is impermeable to moisture and gas. Examples of such materials include foil bags, which typically include aluminum or cobalt foil layers laminated between one or more polymer layers (e.g., polyester, polyamide, and / or polyethylene). Some examples include a portion configured to be torn off 62, such as including a notch, a tear tab, or a tear strip, such as Figure 7 The moisture barrier container 60 may be further contained in an outer container 50, such as a box or carton.

[0137] In one example, packaging system 100 may include one or more sensors 52, such as radio frequency identification tags, including optional buffers to reduce signal interference, temperature sensors, and relative humidity sensors. Figure 8200, and / or the valve housing 300. In one aspect, one or more sensors 52 may be disposed on the outer container 50 and / or defined within an enclosed space within the outer container 50, the moisture barrier container 60, the storage tray 200, or the valve housing 300. For example, an RFID tag may be used to uniquely identify a package or device, the RFID tag being used for inventory counting or reporting the precise identification of a prosthetic valve used in a particular procedure. RFID technology permits automation of steps that are traditionally performed manually, thereby improving efficiency and reducing errors. In some instances, an RFID tag replaces a human-readable identification tag that is often attached to a prosthetic valve using, for example, sutures.

[0138] In another example, the packaging system 100 may also include one or more indicators 54 that may display a message if the packaging system 100 has experienced environmental conditions that exceed acceptable limits detected by one or more sensors for storing the bioprosthetic heart valve 10. In one aspect, the indicator 54 may be disposed on the outer container 50 and / or defined within an enclosed space within the outer container 50, the moisture barrier container 60, the storage tray 200, or the valve housing 300. Figure 8 In the example depicted in FIG. 5 , the indicator 54 may be disposed within the outer container 50 but may be visible through a transparent window without opening the outer container.

[0139] In one example, sensor 52 is a temperature sensor and indicator 54 is a temperature indicator capable of displaying a signal if outer container 50 has experienced a temperature outside of a predetermined and acceptable range for bioprosthetic heart valve 10 during storage and transport.

[0140] In another example, sensor 52 is a relative humidity sensor and indicator 54 is a relative humidity indicator. The relative humidity indicator can display a signal that the relative humidity sensor detects a relative humidity that is outside a predetermined and acceptable range for bioprosthetic heart valve 10.

[0141] In one example, instructions for transferring the packaging system 100 from a non-sterile site to a sterile site may be associated with the outer container 50. The instructions may be provided on a label 56 affixed to the outer surface of the outer container 50, such as Figure 8 It is depicted, or provided, as a separate sheet that includes the outer container 50. The instructions may identify the non-sterile components (eg, the outer container 50 and the moisture barrier container 60) and the sterile components (the packaging system 100).

[0142] Once the outer container 50 is received, the temperature indicator is referenced to determine whether the outer container 50 has experienced an unacceptable temperature. If the outer container 50 has not experienced an unacceptable temperature excursion, the moisture barrier container 60 is removed from the outer container 50. It should be understood that these steps are typically performed in a non-sterile field.

[0143] The transfer of the storage tray 200 from the non-sterile site to the sterile site begins with the opening of the moisture barrier container 60. In one example, the moisture barrier container 60 includes a relative humidity sensor. The relative humidity indicator is referenced to determine whether the relative humidity has exceeded an acceptable range. In one example, a person in the non-sterile site can open the moisture barrier container 60 and another person in the sterile site can carefully receive the packaging system 100. In another example, a single person can simply open the moisture barrier container 60 and simply empty the packaging system 100 onto the surface in the sterile site. It should be understood that the person in the non-sterile site avoids any direct physical contact with the packaging system 100. Once in the sterile site, the microbial barrier film 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 gripping the upper peripheral edge 301 of the valve housing 300 without touching the outer tray sidewall 225 or the tray lip 212.

[0144] As previously discussed, the valve housing 300 can be delivered to a sterile area, such as an operating room, by carefully grasping the sides of the valve housing 300 and lifting it from the storage tray 200 or by simply inverting the storage tray 200 to contain hands or an area and allowing the valve housing 300 to fall out. The valve housing 300 can then be opened by moving the tabs 395A, 395B away from each other. Figures 3A to 3D 395A extends from the cavity lip 312 and the other tab 395B extends from the cover 350. The tabs 395A, 395B can be offset to permit separation with one hand. Once opened, the bioprosthetic heart valve 10 can be hydrated within the cavity 340 by adding a liquid solution (e.g., saline) to soak the valve present therein prior to implantation.

[0145] It will be appreciated that the foregoing description provides an improved packaging assembly having a desired range of interference forces over a wide range of interference widths, thereby securely maintaining a bioprosthetic heart valve within the packaging system while also allowing easy removal of the heart valve from the packaging system without damage or contamination.

[0146] Specific methods, devices, and materials are described, but any methods and materials similar or equivalent to those described can be used in the practice or testing of the present examples. 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.

[0147] The terms "a", "an", and "at least one" encompass one or more of the specified elements. That is, if there are two of a particular element, then there is also one of these elements and therefore there is an "one" element. The terms "a plurality of" and "plural" mean two or more of the specified elements. The term "or" used between the last two in a list of elements means 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 coupled items in the absence of specific contrary language.

[0148] Without further elaboration, it is believed that the foregoing description enables one skilled in the art to carry out and use the technology to the greatest extent possible. The detailed description provides only the currently preferred examples. One of ordinary skill in the art will appreciate that various modifications may be made without departing from the scope of the present disclosure, which is defined solely by the appended claims.

Claims

1. A system for dry storage of bioprosthetic heart valves, characterized in that The system comprises: A valve housing sized to removably retain a bioprosthetic heart valve comprising a stent having a diameter d s The support and cover have a diameter d hv A compressible fabric on at least a portion of an outer surface of the stent, the valve housing comprising: a cavity sized to accommodate the bioprosthetic heart valve and to receive and retain a fluid for hydrating the bioprosthetic heart valve prior to implantation in a patient, the cavity comprising an upper cavity opening, a cavity lip surrounding the upper cavity opening, a bottom wall, and an inner side wall; wherein when the bioprosthetic heart valve is positioned within the cavity, the opposing surfaces of the inner sidewall contact the bioprosthetic heart valve to inhibit rotation and lateral movement of the bioprosthetic heart valve within the cavity; wherein at least a portion of the opposing surfaces of the inner sidewalls are spaced apart to compress only the compressible fabric of the bioprosthetic heart valve and not the stent, such that the diameter d of the stent is s remain unchanged; a lid including 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; and a plurality of undulations formed on one or both of the lid periphery and the cavity lip; wherein in the closed position, at least a portion of the periphery of the cover and at least a portion of the cavity lip surrounding the upper cavity are bonded together; The plurality of undulations permit sterilizing gas to pass between the periphery of the cover and the cavity lip and into the cavity to sterilize the bioprosthetic heart valve; and The inner surface of the cover faces the bottom wall and is spaced apart from the bioprosthetic heart valve by a length l. hv The same distance l lb The bioprosthetic heart valve is spaced apart to inhibit movement of the bioprosthetic heart valve within the valve housing along a longitudinal axis of the bioprosthetic heart valve.

2. The system of claim 1, wherein the valve housing further comprises an outer sidewall spaced apart from the inner sidewall, the outer sidewall increasing the volume of the cavity to retain the liquid for hydrating the bioprosthetic heart valve.

3. The system according to claim 1, characterized in that Further included is 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 close 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 unitary piece of material.

5. The system of claim 3, wherein the storage tray comprises no separate components that are physically joined together.

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

7. The system of any one of claims 3 to 5, wherein the microbial barrier membrane is permeable to a sterilizing gas.

8. The system of any one of claims 3 to 5, wherein the storage tray and the valve housing are shaped to inhibit 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 each other when the valve housing is placed within the storage tray.

10. The system of claim 9, wherein the mating surfaces are configured to inhibit rotation and lateral movement of the valve housing within the storage tray.

11. The system of claim 9 or claim 10, wherein the mating surface does not inhibit movement of the valve housing from the storage tray out of the upper tray opening.

12. The system of claim 9 or claim 10, wherein the mating surface is configured to position the valve housing in a particular orientation relative to the storage tray.

13. A system according to claim 9 or claim 10, wherein the mating surfaces engage each other without friction.

14. The system of claim 9 or claim 10, wherein the mating surface comprises a male key formed by one of the valve housing and the storage tray, and a female key formed by the other of the valve housing and the storage tray.

15. The system of claim 14, wherein the female key is formed as a channel on the storage tray having an open end, a closed end, and a channel width w between the open end and the closed end. f The U-shaped channel, wherein the male key is formed as a protrusion on the valve housing that fits into the U-shaped channel, wherein the protrusion has a width smaller than the channel width w f The protrusion width w p .

16. The system of claim 15, wherein the open end of the U-shaped channel faces the upper tray opening such that inverting the storage tray causes the valve housing to fall from the storage tray when the microbial barrier membrane is removed.

17. The system of any one of claims 3 to 5, 9 to 10, and 15 to 16, wherein the storage tray further comprises one or more finger retainers formed by an outer surface of the storage tray.

18. The system of claim 17, wherein the finger holder further comprises a grip enhancing ridge.

19. A system according to any one of claims 3 to 5, 9 to 10, 15 to 16 and 18, wherein the storage tray includes inner tray side walls to secure the valve housing, and wherein the outer tray side walls are spaced far enough from the inner tray side walls to allow a user to grasp the upper peripheral edge of the valve housing without touching the outer tray side walls.

20. The system according to any one of claims 3 to 5, 9 to 10, 15 to 16 and 18, characterized in that Further included is a moisture barrier container configured to receive the storage tray and the valve housing retained therein.

21. The system of claim 20, wherein the moisture barrier container is impermeable to gas.

22. The system according to claim 20, characterized in that Further included is an outer container configured to house the moisture barrier container containing the storage tray and the valve housing retained therein.

23. The system of claim 22, wherein the system comprises one or more of: a radio frequency identification tag, a temperature sensor, or a relative humidity sensor.

24. The system of claim 23, wherein the system comprises a radio frequency identification tag and wherein the outer container further comprises a buffer to reduce signal interference.

25. The system of claim 23 or claim 24, wherein the system comprises a temperature sensor and wherein the external container further comprises a temperature indicator, wherein the temperature indicator displays a signal when the external container has experienced a temperature outside a predetermined temperature range.

26. A system according to claim 23 or claim 24, wherein the system includes a relative humidity sensor enclosed in the moisture barrier container, and wherein the system further includes a relative humidity indicator that displays a signal when the relative humidity sensor detects that the relative humidity is outside a predetermined relative humidity range.

27. The system according to any one of claims 22 to 24, characterized in that Further included is a label with instructions allowing for aseptic transfer of the bioprosthetic heart valve to a sterile field of an operating room by identifying sterile and non-sterile contents.

28. A system for dry storage of bioprosthetic heart valves, characterized in that The system comprises: A valve housing sized to removably retain a bioprosthetic heart valve, the valve housing comprising: a cavity sized to receive a bioprosthetic heart valve and to retain a fluid for hydrating the bioprosthetic heart valve prior to implantation in a patient, the cavity comprising an upper cavity opening, a bottom wall, and an inner sidewall, the inner sidewall contacting the bioprosthetic heart valve when the bioprosthetic heart valve is positioned within the cavity to inhibit rotation and lateral movement of the bioprosthetic heart valve within the cavity; a lid configured to be secured to the upper cavity opening, the lid including a lid inner surface that faces 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; and One or more apertures for admitting sterilizing gas into the cavity when the lid is in the closed position.

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

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

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

32. The system of claim 28, wherein the valve housing is made of a material consisting of: a thermoformed plastic.

33. The system of claim 32, wherein the thermoformed plastic is polyethylene terephthalate.

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

35. A system according to claim 34, wherein the valve housing further includes first and second offset tabs, and the first and second offset tabs are configured to allow a user to open the cover from the closed position to the open position with one hand, wherein the first offset tab is formed by the cover and the second offset tab is formed by the cavity lip.

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

37. A system according to claim 36, wherein the lid includes a lid periphery having a first set of undulations, and the cavity lip includes a second set of undulations, and wherein when the lid is in the closed position, the first set of undulations and the second set of undulations meet to form the one or more apertures.

38. The system of any one of claims 28 to 33 and 35 to 37, wherein the valve housing comprises a living hinge between the cavity and the cover.

39. The system of any one of claims 28 to 33 and 35 to 37, wherein the bioprosthetic heart valve comprises a stent and an outer surface.

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

41. The system of claim 40, wherein the fabric surrounds at least a portion of the stent, and wherein the fabric has a loft that permits radial compression thereof without damaging the bioprosthetic heart valve.

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

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

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

45. The system of claim 44, wherein the diameter d of the bioprosthetic heart valve is hv The distance l between the surface opposite to the inner wall iw same.

46. ​​The system of claim 44, wherein the distance l between the opposing surfaces of the inner sidewalls is iw Smaller than the diameter d of the bioprosthetic heart valve hv .

47. The system of claim 46, wherein the distance l between the opposing surfaces of the inner sidewalls is iw Greater than the diameter d of the stent s .

48. The system of any one of claims 44 to 47, wherein an inner surface of the cover faces the bottom wall and is spaced apart from the bioprosthetic heart valve by a length l. hv The same distance l lb The cap is spaced apart to inhibit longitudinal movement of the bioprosthetic heart valve within the valve housing when the cap is in the closed position.

49. The system of claim 48, wherein the cap interior surface comprises a cylindrical cap cavity shaped to receive a top portion of the bioprosthetic heart valve, wherein the cylindrical cap cavity has a diameter d of lc Greater than the diameter d of the stent s or the diameter d of the bioprosthetic heart valve hv .

50. The system of any one of claims 28 to 33, 35 to 37, 40 to 47 and 49, wherein the valve housing further comprises a marking identifying the bioprosthetic heart valve.

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

52. The system of claim 51, wherein the marking indicates a size of the bioprosthetic heart valve, and wherein the marking is thermoformed on the cover and the bottom wall.

53. The system of any one of claims 28 to 33, 35 to 37, 40 to 47, 49 and 51 to 52, wherein the bioprosthetic heart valve is secured within the opposing surface of the inner side wall by frictional engagement between the side wall and fabric.

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

55. The system of claim 45, wherein the valve housing further comprises an outer wall, wherein a distance l between opposing surfaces of the outer wall is os greater than the distance l between the opposing surfaces of the inner side wall iw , and wherein the opposing surface of the outer wall does not contact the bioprosthetic heart valve.

56. The system of any one of claims 28 to 33, 35 to 37, 40 to 47, 49, 51 to 52, and 54 to 55, wherein the valve housing is formed from a single unitary piece of material.

57. A system according to any one of claims 28 to 33, 35 to 37, 40 to 47, 49, 51 to 52 and 54 to 55, wherein the valve housing does not include separate components that are physically joined together.

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