Abstract: Medical device packaging can facilitate sterilization or other processes for medical devices disposed within the packaging. For example, medical device packaging can include a gas-permeable channel that permits a gas to enter and exit the packaging where a medical device is located, while preventing microorganisms from entering or exiting the packaging. The gas-permeable channel can be implemented within a seal of the packaging, a surface of the packaging, or elsewhere. The gas-permeable channel preferably includes a tortuous path, or a path that is longer than a predetermined threshold, for preventing contamination of the medical device contained within the package.

Abstract: A container configured to receive a dock assembly therein for packaging is disclosed. The container can include: a base defining an engagement surface configured to receive the dock assembly; a lid configured to releasably engage with the base such that at least a portion of the dock assembly is disposed between the base and the lid; and a dock holder affixed to the container and configured to receive a first portion of the dock assembly comprising two or more adjacent coils thereon. The dock holder can comprise a protrusion configured to engage the first portion of the dock assembly and space a second portion of the dock assembly away from the dock holder.

Abstract: A temperature-protective package includes a rigid container configured to receive a temperature-sensitive product. A flexible liner is attached to the rigid container such that a pocket is formed between the rigid container and the flexible liner. Phase change material (PCM) is situated in the pocket. The PCM conforms to a contoured surface of the rigid container. In an alternative implementation, a temperature-sensitive package includes a pocket of PCM within a flexible liner. The flexible liner defines a preferred shape of the temperature-protective package. The flexible liner also defines an opening for receiving a product. The opening corresponds to the preferred shape. In one implementation, multiple flexible liners can be utilized to define the preferred shape and the opening.

Abstract: A valve cover apparatus for use in a medical assembly including a prosthetic valve and a valve delivery apparatus. The valve cover apparatus includes a housing, a chamber disposed within the housing for receiving a prosthetic heart valve in an at least partially expanded state, a tapered surface defining a portion of the chamber, and a lock ring that is axially movable over at least a portion of the housing between a locked position and an unlocked position. The tapered surface is enables loading and/or guiding of the prosthetic heart valve from the chamber of the valve cover apparatus into a delivery sheath of the valve delivery apparatus and transition the prosthetic heart valve to a radially compressed state. The lock ring restricts movement of the valve cover relative to the delivery sheath when in the locked position, and enables movement of the valve cover when in the unlocked position.

Abstract: A method for preparing a prosthetic valve and a delivery system for an implantation procedure. The method comprises (a) obtaining a tray, the tray containing the delivery system, the prosthetic valve coupled to the delivery system, and a valve cover in which the prosthetic valve is disposed. The tray comprises a storage cavity comprising an open end, a floor, and a peripheral side wall defining the depth of the cavity, wherein the prosthetic valve and the valve cover are disposed in the storage cavity; and a mounting surface that substantially immobilizes and maintains the valve cover and prosthetic valve within the storage cavity. The method further comprises (b) at least partially filing the storage cavity with a first hydrating fluid to completely immerse the prosthetic valve; and (c) removing the delivery device with the prosthetic valve from the tray, including disengaging the prosthetic valve from the mounting surface.

Abstract: An assembly includes a holder device and a non-self-expandable prosthetic heart valve. The prosthetic heart valve can be radially compressed from an expanded configuration to a compressed configuration. The holder device is configured to hold the prosthetic heart valve in the expanded configuration and to allow the prosthetic heart valve to be inserted in a crimping device so that the prosthetic heart valve can be crimped onto a valve mounting portion of a delivery apparatus.

Abstract: A method for preparing a prosthetic valve and a delivery system for an implantation procedure. The method comprises (a) obtaining a tray, the tray containing the delivery system, the prosthetic valve coupled to the delivery system, and a valve cover in which the prosthetic valve is disposed. The tray comprises a storage cavity comprising an open end, a floor, and a peripheral side wall defining the depth of the cavity, wherein the prosthetic valve and the valve cover are disposed in the storage cavity; and a mounting surface that substantially immobilizes and maintains the valve cover and prosthetic valve within the storage cavity. The method further comprises (b) at least partially filing the storage cavity with a first hydrating fluid to completely immerse the prosthetic valve; and (c) removing the delivery device with the prosthetic valve from the tray, including disengaging the prosthetic valve from the mounting surface.

Abstract: A packaging system for storing a prosthetic valve and an elongated delivery system in a non-fluid environment. The packaging system includes a tray for securing both a prosthetic valve and an elongated delivery system. The tray includes a cavity sized and shaped to house a valve cover containing the prosthetic valve and at least part of the distal portion of the elongated delivery system. A mounting surface removably couples the valve cover to the cavity floor and to prevent the valve cover from moving. An engaging surface is disposed peripherally of the cavity and is elevated above the cavity floor. A ramp extends downwardly from the engaging surface and into the cavity through an opening defined in the peripheral side wall and adjacent the floor of the cavity. The engaging surface and ramp are configured to secure at least part of the elongated delivery system externally of the cavity.

Abstract: A packaging system for storing a prosthetic valve and an elongated delivery system in a non-fluid environment. The packaging system comprises a tray for securing both a prosthetic valve and an elongated delivery system. The tray includes a cavity sized and shaped to house a valve cover containing the prosthetic valve and at least part of the distal portion of the elongated delivery system. A mounting surface removably couples the valve cover to the cavity floor and to prevent the valve cover from moving. An engaging surface is disposed peripherally of the cavity and is elevated above the cavity floor. A ramp extends downwardly from the engaging surface and into the cavity through an opening defined in the peripheral side wall and adjacent the floor of the cavity. The engaging surface and ramp are configured to secure at least part of the elongated delivery system externally of the cavity.