Edwards Lifesciences Corporation

Gregory G Liburd

Abhishek Gautam

Vipul P Rajpara

Ryan Mourhatch

Abishek Gautam

Astrid Lorraine Melgar

Vikas A Patel

Packaging systems and methods are disclosed for storing a bioprosthetic device comprising a bioprosthetic tissue and maintaining a target relative humidity across a temperature range. The packaging system includes a sealed package defining an internal space having an internal volume, and a humidity control device and bioprosthetic device within the internal space. The humidity control device includes a barrier defining an enclosed space and a humidity control solution comprising glycerol in the enclosed space. At least a portion of the barrier comprises a gas-permeable membrane. The target relative humidity is provided within the internal volume of the sealed package and the control device maintains the target relative humidity across the temperature range by selectively liberating and absorbing water vapor.

Humidity-management packaging systems and methods

Packaging for prosthetic heart valves including an assembly for stabilizing dry prosthetic tissue implants such as heart valves during storage. The packaging assembly can be used for storing a bioprosthetic heart valve without a liquid preservative solution. The packaging assembly can have a valve holder configured for removably attaching a bioprosthetic heart valve, a storage tray comprising an open end and a cavity, and a retaining member configured for removably attaching the valve holder. The retaining member can be generally planar and have a slot having a closed end and an open outer end. The valve holder can be configured to be retained at the closed end of the slot in the retaining member.

Dry prosthetic heart valve packaging system

Packaging for prosthetic heart valves including an assembly for stabilizing dry prosthetic tissue implants such as heart valves during storage. The packaging assembly can be used for storing a bioprosthetic heart valve without a liquid preservative solution. The packaging assembly can comprise a holder comprising an engagement structure configured for removably attaching a bioprosthetic heart valve, the holder comprising a shaft. The packaging assembly can also include a storage tray comprising a cavity and an insert sized to provide a cap over the cavity of the storage tray, the insert comprising a slot having a closed central end and an open outer periphery. The shaft of the holder can be non-rotatably retained at the closed central end, wherein the insert defines a flat, generally planar disc comprising at least one of outward projections and flow passages.

A packaging assembly for storing a bioprosthetic heart valve without a liquid preservative solution is provided. The packaging system includes a holder, a cage, a storage tray and an insert sized to provide a cap over the cavity of the storage tray. The holder comprises a shaft and an engagement structure configured for removably attaching a bioprosthetic heart valve. The cage comprises an upper end, the cage configured to at least partially enclose the bioprosthetic heart valve. The storage tray comprises a cavity for housing the cage. The insert comprises a slot having a closed central end and an open outer periphery, the shaft of the holder being non-rotatably retained at the closed central end. The insert defines a flat, generally planar disc comprising at least one of outward projections and flow passages. The packaging assembly does not comprise a liquid preservative solution.

Packaging for prosthetic heart valves including an assembly for stabilizing dry prosthetic tissue implants such as heart valves during storage. The packaging assembly includes a primary sterile barrier that permits gas sterilization of the tissue implant, and a secondary sterile barrier that prevents oxidation of the implant during storage. Tissue heart valves are placed inside an inner tray and sealed with a gas-permeable lid. The inner tray is placed within an outer sterile barrier and the assembly is sterilized. The outer sterile barrier may include a double seal so that a first gas-permeable seal can be closed for sterilization, after which a second gas-impermeable seal is closed to seal out any further oxygen contact with the tissue implant. Alternatively, the inner tray is placed within a sterile pouch and the assembly gas-sterilized, and then the entire assembly is placed within another pouch that provides an impermeable barrier.

Packaging for prosthetic heart valves including an assembly for stabilizing dry prosthetic tissue implants such as heart valves during storage. The packaging assembly includes a primary sterile barrier that permits gas sterilization of the tissue implant, and a secondary sterile barrier that also prevents oxidation of the implant during long-term storage. Tissue heart valves may be placed or suspended within a cavity of an inner rigid tray with a gas-permeable lid sealed thereon, and a cap placed over the cavity to limit movement of the valve therein. The inner tray is placed within an outer sterile barrier, such as another rigid tray or a flexible pouch, and the assembly is then sterilized. The outer sterile barrier may include a double seal so that a first gas-permeable seal can be closed for sterilization, after which a second gas-impermeable seal can be closed to seal out any further oxygen contact with the tissue implant. Alternatively, the inner tray may be placed within a sterile pouch and the assembly gas-sterilized, and then the entire assembly is placed within another pouch that provides an impermeable barrier to the surrounding atmosphere to prevent oxidation of the tissue implant.

Growing community of inventors

Riverside, CA, United States of America

Gregory G Liburd