Long-Term Storage for Prosthetic Heart Valves

Dry packaging for medical devices like bioprosthetic heart valves that eliminates the need for sterilant solutions like glutaraldehyde. The packaging uses a sealed container with a removable lid that allows hydration of the valve before implantation. The container walls compress the valve to retain it. The lid can have features to facilitate single-handed opening. The valve is dry-packed to reduce calcification risks compared to wet storage. The container shape inhibits valve movement. The lid can have indicia to identify valve size. The container can nest in a tray for shipping.

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Packaging and biasing method for dry storage of prosthetic heart valves to prevent leaflet deformation during shipping and sterilization. The method involves shaping the valve leaflets into a desired configuration before dehydration and sterilization. The valve is inserted into a packaging component with biasing elements that secure the leaflets. This prevents leaflet collapse during drying and sterilization. The dry packaged valve can be stored and shipped without fluid.

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Storage assembly for sterilizing medical devices like heart valves using ethylene oxide gas without damaging the implant. The assembly has an inner container with the implant in sterilization fluid, sealed to the delivery device. An outer container around the inner one contains water. Sterilizing with ethylene oxide gas allows it to breach the inner seal. If any gas escapes, it contacts the water and converts to less damaging ethylene glycol and ethylene chlorohydrin. Activated carbon in the outer container absorbs any residual glycol/chlorohydrin.

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A packaging system for artificial heart valves that provides stable and safe storage and transportation of the valves. The system consists of multiple nested boxes with positioning features that prevent movement of the valve during handling. The innermost box has a clamping device with a groove to hold the valve in place. The outer box fits over the innermost box and secures the valve inside. This two-box system with clamping and positioning features ensures the valve stays stable during shipping and prevents damage from impact or movement.

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Sterile barrier packaging systems for solution-sterilized prosthetic heart valves that provide easier access and improved protection compared to conventional glass jar packaging. The systems involve using containers with lids that don't require threaded connections. The lids can be peeled off or easily opened to access the valve, unlike threaded lids that can be difficult to remove. The lids can be thin foil or film sealed to the container. This allows consistent, easy opening by end users compared to threaded jars. The packaging also provides better thermal and physical protection compared to secondary packaging around glass jars. The valves can be stored and shipped in these containers without additional secondary packaging.

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Storage jar assembly for prosthetic heart valves that allows safe shipping, storage, and handling of the valves while preventing damage. The assembly has a jar with a lid that secures the valve in a partially compressed state. The lid has features to attach to the valve and release it. This prevents valve contact with jar walls during shipping. The compressed state allows smaller jars. The jar can also have a holder inside to compress the valve. The lid release mechanism detaches the valve for removal.

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Packaging and sterilizing technique for "wet" stored prosthetic heart valves that are preloaded onto a portion of a delivery device. The valve is placed in a sealed container filled with sterilization fluid like glutaraldehyde. The container has seals at two positions along the delivery device. The valve is sterilized with the first seal in place, then the first seal is removed and a second seal formed further down the device. This allows separate sterilization processes for the valve and proximal delivery device area. The seals can be formed by the same or different components. After sterilization, the second seal is removed for final sterilization of the entire assembly.

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Packaging of dry tissue heart valves and their delivery systems for sterile storage and delivery. The packaging uses a primary container with a gas-permeable seal and a secondary container with a gas-impermeable seal. The dry valve and delivery system are sealed in the primary container. The primary container is then placed in the secondary container. The gas-permeable seal allows gas exchange while preventing contamination. The sealed containers are sterilized using gas sterilization. This avoids preservation fluids like glutaraldehyde. The dry valves can be expanded and delivered using retractable handles with telescopic sections. The gas-permeable packaging allows expansion without breaking the seal. The retractable handles provide compact storage and easy expansion in the body.

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Sealed system for delivering a replacement heart valve that allows biologically derived valves to be stored and shipped in a sterile environment without dehydration. The system consists of the valve, delivery catheter, and installation elements enclosed in a sterile container filled with fluid. This keeps the valve hydrated during storage and shipping. The container has caps, a catheter ferrule, and a radiopaque sleeve to seal and connect to the catheter.

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Packaging for sterile storage of dry prosthetic heart valves that is lighter and less bulky than current liquid-filled packaging. The packaging uses a double sterile barrier to protect the dry tissue implant during sterilization, transit, and storage. The inner barrier is a tray with a lid that suspends and secures the valve. The outer barrier is a secondary container that holds the tray and is sealed for gas sterilization. Then the outer container is sealed with an impermeable barrier to prevent oxidation.

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Packaging and sterilization method for wet storage of prosthetic heart valves that are delivered using a catheter into the heart. The packaging involves a container filled with sterilizing solution like glutaraldehyde to preserve the valve. The container has seals at two positions. One seal is near the valve and the other further away. The valve is loaded on the catheter and placed in the container near the first seal. The container is then sealed. The valve is sterilized by filling the container with the solution. After sterilization, the second seal is added and the container section with the valve is drained. This allows sterilization of components proximal to the second seal.

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Packaging for dry tissue prosthetic heart valves that prevents drying out during storage and sterilization. The packaging includes a container with separate compartments. The valve is stored in one compartment with a hydrogel that regulates humidity. The hydrogel balances container humidity and its own water holding capacity to prevent valve tissue drying. A hygroscopic substance like glycerol can also be added to the hydrogel. This creates a humid greenhouse atmosphere inside the container.

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Pre-assembled bioprosthetic heart valves and sealing catheters that can be dried and stored without preservation fluid. The bioprosthetic valve is made of treated tissue that can be stored dry without loss of function. The catheter is sealed with a bioresorbable material like gelatin. The valve and catheter are pre-assembled and dried before storage. This allows simple implantation without exposing the valve to moisture in the operating room that could degrade the tissue. The catheter extends at both ends of the valve for inflow and outflow. The valve is secured to the catheter with sutures or a snap connection. The packaging has a limited desiccant to maintain the valve's moisture level while drying the catheter.

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A packaging system for prosthetic heart valves that maintains the valves in a hydrated state without using preservative solutions. The system uses a humidifier gel inside the packaging jar to prevent tissue valve drying. The valve is not submerged in storage solution. The gel absorbs/releases water to keep the tissue at 60-78.3% moisture. The jar, lid, and liner seal fluid-tightly. The valve can be hydrated or dry when packaged. The gel prevents drying during storage/transport. Sterilization is done before sealing.

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Sterile packaging for dry bioprosthetic heart valves that allows gas sterilization and long-term storage without preservative liquids. The packaging involves a double barrier assembly with an inner tray containing the valve, a cap to limit movement, a gas-permeable lid, and an outer gas-permeable container. The inner tray and valve are sterilized by gas, then sealed in the outer container. This prevents oxidation during storage. The outer container is further sealed to prevent gas transfer.

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A dual sterilization container for medical devices like replacement heart valves to prevent bioactive contamination during sterilization and storage. The container has a sealed cavity to hold the biologically derived medical component and a catheter lumen. It has covers at each end and a wire sleeve. The proximal cover has a snare to seal onto the catheter. The dual sterilization is achieved by running the container inside the medical device system during high-radiation sterilization to ensure all components are sterilized. This reduces bioactive contamination risk compared to just sterilizing the device. The sealed container also maintains hydration of the biological component during storage.

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