Abstract: Aspects of the disclosure relate to storage assemblies including at least part of a delivery device and an implant. The storage assemblies are configured to trap sterilizing ethylene oxide gas using its high water solubility and converting the escaped ethylene oxide to less detrimental ethylene glycol and ethylene chlorohydrin to protect the implant from damage. In one example, the storage assembly includes an inner container housing the implant and sterilizing fluid and an outer container positioned over the inner container, wherein the outer container is at least partially filled with aqueous water. The implant may be a prosthetic heart valve. Aspects of the disclosure also relate to methods of sterilizing the storage assemblies of the disclosure.

Abstract: A method includes hermetically sealing a medical device within a pouch, the pouch including peeling panels that are free from one another. The pouch is placed within a tray and the peeling panels are attached to unloading handles of the tray. The unloading handles are releasably coupled together. The method further includes simultaneously separating the unloading handles and the peeling panels to open the pouch and expose the medical device for removal thereof.

Abstract: A device retention assembly includes a delivery system and a device retention mechanism retaining the delivery system. The device retention mechanism includes a tray, a base coupled to the tray, and retaining flanges pivotally coupled to the base. The delivery system is enclosed within an opening defined by the base and retaining flanges. A key locks the device retention mechanism in the closed position retaining the delivery system. The key must be removed to unlock the device retention mechanism to release the delivery system.

Abstract: A method includes hermetically sealing a medical device within a pouch, the pouch including peeling panels that are free from one another. The pouch is placed within a tray and the peeling panels are attached to unloading handles of the tray. The unloading handles are releasably coupled together. The method further includes simultaneously separating the unloading handles and the peeling panels to open the pouch and expose the medical device for removal thereof.

Abstract: In accordance with one embodiment, a method of capturing biomatter includes placing a device comprising the biomatter within an extension tube, the extension tube being coupled to a tray. A fold is created in the extension tube sealing the extension tube and the biomatter contained therein. The extension tube is secured to the tray to maintain the fold. The assembly is discarded, e.g., into a bio-waste disposal bag in a bio-waste container. The fold is a smooth fold, in contrast to a sharp tip, thus minimizing the possibility of puncture of the bio-waste disposal bag.

Abstract: Aspects of the disclosure relate to packaging assemblies including a tray having at least one compartment adapted to receive a medical device component or product. The packaging assemblies a barrier film covering the compartment and a lid pivotally attached to the tray; wherein the tray and the lid each include cooperative latching features. The lid defines a recess in which one or more product items can be stored and the packaging assembly further includes a label removably secured over the recess and the sheet of product documentation. Methods of assembling, sterilizing and opening such packaging assemblies are also disclosed.

Abstract: A delivery system package includes a tray, a delivery system, and a slip card between the tray and the delivery system. To remove the delivery system, a pull tab of the slip card is moved to raise the slip card including the delivery system from the tray. At the same time, this moves the slip card over a lid sealing flange of the tray, considered a non-sterile surface in accordance one embodiment. Accordingly, the slip card extends over the lid sealing flange preventing contact between the delivery system and the lid sealing flange. In addition, the slip card effectively forms a ramp for sterile removal of the delivery system from the tray.

Abstract: Aspects of the disclosure relate to packaging assemblies including a tray having at least one compartment adapted to receive a medical device component or product. The packaging assemblies a barrier film covering the compartment and a lid pivotally attached to the tray; wherein the tray and the lid each include cooperative latching features. The lid defines a recess in which one or more product items can be stored and the packaging assembly further includes a label removably secured over the recess and the sheet of product documentation. Methods of assembling, sterilizing and opening such packaging assemblies are also disclosed.

Abstract: In accordance with one embodiment, a long medical device is sealed within a clean release split carton. The clean release split carton includes a first carton tube coupled to a second carton tube by a closure label. To open the clean release split carton, a tear string is pulled to tear the closure label thus separating the first carton tube from the second carton tube. The individual carton tubes are then removed from the medical device. The clean release split carton avoids the generation of particulates while opening the carton and make removing the medical device easier.

Abstract: A device retention assembly includes a delivery system and a device retention mechanism retaining the delivery system. The device retention mechanism includes a tray, a base coupled to the tray, and retaining flanges pivotally coupled to the base. The delivery system is enclosed within an opening defined by the base and retaining flanges. A key locks the device retention mechanism in the closed position retaining the delivery system. The key must be removed to unlock the device retention mechanism to release the delivery system.

Abstract: A carton for a medical device includes a cover and an inner sidewall coupled to the cover. The inner sidewall includes a locking tab receiving slot. The carton further includes a first outer sidewall assembly comprising a self-locking tab configured to be inserted into the locking tab receiving slot, the self-locking tab having a first width greater than a second width of the locking tab receiving slot. The self-locking tab utilizes the geometry of the carton to create the seal. The self-locking tab is cut in a specific shape such that when it is inserted into the locking tab receiving slot, the self-locking tab locks the carton closed. Further, a perforated cut around the locking tab receiving slot allows a locking tab release flap of the carton to be lifted, freeing the self-locking tab so the carton may be opened.

Abstract: A device retention assembly includes a delivery system and a device retention mechanism retaining the delivery system. The device retention mechanism includes a tray, a base coupled to the tray, and retaining flanges pivotally coupled to the base. The delivery system is enclosed within an opening defined by the base and retaining flanges. A key locks the device retention mechanism in the closed position retaining the delivery system. The key must be removed to unlock the device retention mechanism to release the delivery system.

Abstract: In accordance with one embodiment, a method of capturing biomatter includes placing a device comprising the biomatter within an extension tube, the extension tube being coupled to a tray. A fold is created in the extension tube sealing the extension tube and the biomatter contained therein. The extension tube is secured to the tray to maintain the fold. The assembly is discarded, e.g., into a bio-waste disposal bag in a bio-waste container. The fold is a smooth fold, in contrast to a sharp tip, thus minimizing the possibility of puncture of the bio-waste disposal bag.

Abstract: A device retention assembly includes a delivery system and a device retention mechanism retaining the delivery system. The device retention mechanism includes a tray, a base coupled to the tray, and retaining flanges pivotally coupled to the base. The delivery system is enclosed within an opening defined by the base and retaining flanges. A key locks the device retention mechanism in the closed position retaining the delivery system. The key must be removed to unlock the device retention mechanism to release the delivery system.

Abstract: A catheter delivery system package includes a tray, an extension tube coupled to the tray, an end cap sealing an end of the extension tube, and a lid coupled to the tray. The sealed rigid tray provides a highly robust sterile barrier, free of folds and abrasions. By eliminating compound folds, the possibility of failure of the catheter delivery system package is minimized. In addition, the catheter delivery system package has a reduced package volume. Further, the catheter delivery system package is 100% recyclable.

Abstract: A package for a medical device having an elongated shaft and a proximal luer fitting, the package includes a one-piece body formed as a single structure. The one-piece body includes at least a spiral casing formed therein, the spiral casing defining a spiral lumen configured to receive the elongated shaft of the medical device. The package includes a luer retaining portion at one end of the spiral casing with barrier film sealed to the luer retaining portion to maintain the sterility of the medical device. The package further including a cap placed over the luer retaining portion and barrier film to protect the integrity of the barrier film and prevent perforation of the barrier film which would compromise the sterility of the medical device.

Abstract: A package for a medical device having an elongated shaft and a proximal luer fitting, the package includes a one-piece body formed as a single structure. The one-piece body includes at least a spiral casing formed therein, the spiral casing defining a spiral lumen configured to receive the elongated shaft of the medical device. The package includes a luer retaining portion at one end of the spiral casing with barrier film sealed to the luer retaining portion to maintain the sterility of the medical device. The package further including a cap placed over the luer retaining portion and barrier film to protect the integrity of the barrier film and prevent perforation of the barrier film which would compromise the sterility of the medical device.

Abstract: A package for a medical device having an elongated shaft and a proximal luer fitting includes a one-piece body formed as a single structure via blow molding. The blow-molded one-piece body includes at least a spiral casing formed therein, the spiral casing defining a spiral lumen configured to receive the elongated shaft of the medical device. Webbing is disposed between adjacent curved portions of the spiral casing. The one-piece body formed via blow-molding may also include a removable reversible loading tube, a luer retainer, a cannula holder, one or more slots for attaching an information card thereto, a fastener for clipping the medical device thereto, and a compartment for holding an oxygen scavenger. Further, the one-piece body formed via blow-molding may include non-circular lumens and may be configured to receive multiple medical devices.

Abstract: A package for a medical device having an elongated shaft and a proximal luer fitting includes a one-piece body formed as a single structure via blow molding. The blow-molded one-piece body includes at least a spiral casing formed therein, the spiral casing defining a spiral lumen configured to receive the elongated shaft of the medical device. Webbing is disposed between adjacent curved portions of the spiral casing. The one-piece body formed via blow-molding may also include a removable reversible loading tube, a luer retainer, a cannula holder, one or more slots for attaching an information card thereto, a fastener for clipping the medical device thereto, and a compartment for holding an oxygen scavenger. Further, the one-piece body formed via blow-molding may include non-circular lumens and may be configured to receive multiple medical devices.