Abstract:
A tray and packaging system for a prosthetic valve delivery system permits conversion from a storage and/or shipping configuration to a set up and preparation configuration. In a first configuration, a delivery system can be supported by first and second main trays with the elongate catheter of the delivery system arranged to extend linearly from the first main tray to the second main tray, and in a second configuration, the delivery system can be supported by the first and second main trays with the elongate catheter of the delivery system turned back in a U-shaped manner with the deployment portion of the delivery system positioned to the side of the control handle portion of the delivery system.
Abstract:
A tray and packaging system for a prosthetic valve delivery system permits conversion from a storage and/or shipping configuration to a set up and preparation configuration. In a first configuration, a delivery system can be supported by first and second main trays with the elongate catheter of the delivery system arranged to extend linearly from the first main tray to the second main tray, and in a second configuration, the delivery system can be supported by the first and second main trays with the elongate catheter of the delivery system turned back in a U-shaped manner with the deployment portion of the delivery system positioned to the side of the control handle portion of the delivery system.
Abstract:
A sterile barrier system for medical device packaging. The sterile barrier system includes a layer forming a breathable sterile barrier. The layer includes a plurality of fibers. Each of the fibers includes a hollow fiber body and an agent contained within the hollow fiber body. The fibers are configured such that the agent flows from the corresponding hollow fiber body when the hollow fiber body is severed. When the sterile barrier system is subjected to damage, the agent is released from any hollow fiber body severed by the damage and imparts one or both of repair or visual indication of a possible integrity breach. In some embodiments, the agent is a self-healing agent. In other embodiments, the agent is a dye. In some embodiments, the layer is an electrospun web. A medical device packaged in a sterile barrier system is also provided.
Abstract:
A method of delivering and deploying a prosthetic valve includes percutaneously advancing a catheter to a treatment site, proximally retracting an outer shaft relative to an inner shaft to expose the prosthetic valve such that the prosthetic valve self-expands to a radially expanded configuration, disconnecting a tip retractor from a handle of the catheter, and proximally retracting the tip retractor to proximally retract the inner shaft and a nosecone attached to a distal end of the inner shaft relative to the outer shaft and/or the handle.
Abstract:
A tray and packaging system for a prosthetic valve delivery system permits conversion from a storage and/or shipping configuration to a set up and preparation configuration. In a first configuration, a delivery system can be supported by first and second main trays with the elongate catheter of the delivery system arranged to extend linearly from the first main tray to the second main tray, and in a second configuration, the delivery system can be supported by the first and second main trays with the elongate catheter of the delivery system turned back in a U-shaped manner with the deployment portion of the delivery system positioned to the side of the control handle portion of the delivery system.