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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Loading a heart valve prosthesis onto a delivery instrument for implantation using a loading system that simplifies the process. The loading system has a radially contractible armature that expands and contracts to hold the valve. It also has a gripper that engages the valve in an expanded state. To load the valve, the gripper is moved to contract the armature, releasing the valve. Then, the valve is decoupled from the gripper and inserted into the delivery instrument. This allows the valve to be loaded without manually handling it. The gripper contracts the armature to hold the valve, and decoupling releases it for insertion.

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A prosthetic heart valve holder and packaging that facilitates implantation of the valve by pre-constricting and/or pre-shielding the valve commissure posts to prevent suture looping. The holder has flexible legs that can extend through the valve and cover the commissure post tips. This allows the holder to shield the posts during implantation without sutures. The legs can retract inward to remove the holder after the implant.

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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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Packaging structure for artificial heart valves that allows easy removal of the valve from the packaging without tools or complex operations. The packaging has multiple concentric layers, with at least one inner layer made of hard material. This provides protection during storage and transportation. The inner hard layer prevents the valve from falling out when the outer layers are removed. This allows the valve to be easily accessed and extracted by simply peeling off the outer layers.

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Packaging system for prosthetic heart valves and delivery systems that allows efficient preparation and storage of the devices outside a sterile environment. The system uses a sealed tray with compartments for the valve and delivery system. It prevents contamination while allowing assembly and disassembly without aseptic procedures. The tray can lock the valve and delivery components in position to prevent misalignment during handling. This allows preparing and storing the valves and delivery systems outside the sterile field, reducing time and cost in the operating room compared to full sterilization and assembly procedures.

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A compact crimping device for reducing the size of prosthetic heart valve devices so they can be loaded into a delivery capsule for minimally invasive implantation. The device has a circular channel formed by movable blades that can be driven radially inwards to decrease the diameter. The blades are actuated by slots in stationary and movable plates. The crimping device provides controlled compression of the unexpanded valve to fit within the delivery capsule.

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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 design for prosthetic heart valves that securely retains the valve within a jar and facilitates retrieval therefrom. The packaging assembly includes a jar, a prosthetic heart valve, a valve holder, and a packaging sleeve. The sleeve fits closely within the jar and has a clip structure for securing the valve holder. This allows the valve assembly to be packaged with the valve inverted. A shaft can then be inserted through the valve to attach to the holder and lift the valve out of the jar for implantation.

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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 and sterilizing method for wet-stored transcatheter heart valves to prevent drying while maintaining sterility. The valve is loaded into a container with sterilizing fluid and sealed. A positioning apparatus moves the container along the delivery device to sterilize areas around the seal. This allows sterilization of the valve and delivery device interior without exposing the valve to air. The assembly is sterilized in two steps: initially dry sterilization when the container is at one position, then sterilization of the seal area when the container is moved.

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Packaging assembly for shipping and storing heart valve replacements that secures the valve in place, prevents damage during transportation, and allows pre-tensioning for easier attachment to delivery systems. The assembly has a valve support, a ring that fits around the valve, and a retention mechanism with a cap and sutures. The ring and support lock together with the sutures taut, holding the valve securely inside during shipping. This allows rinsing and attachment of the valve to occur with it already secured in the assembly instead of manually handling the valve. The cap can also have features like threads for attaching to the delivery system.

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Packaging system for medical devices that are coated with fluorinated liquids to reduce thrombus formation, cell adhesion, and biofilm growth. The system has a base with a channel matching the device shape. A cover seals the channel. The device is placed in the channel and the cover closed. The fluorinated liquid is added to the channel before sterilization. This allows the device to be sterilized separately from the liquid. The liquid fills gaps around the device during sterilization to coat it. After sterilization, the cover is removed to expose the channel.

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Packaging system and method for preparing a prosthetic heart valve and delivery system for implantation that reduces the time and risk involved in assembling the valve on the delivery device in the operating room. The system involves a tray with compartments to hold the valve and delivery system in a compressed state. This allows the valve to be preloaded and secured onto the delivery device before packaging. The compressed configuration prevents expansion of the valve during transport. The tray also has features like locks and handles to facilitate assembly and removal of the components. The valve and delivery system are then transported in the compressed state and expanded in the operating room. This eliminates the need for complex and precise assembly steps in the sterile field.

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Preparing sterilized transcatheter heart valves using electron beam radiation that can be crimped, packaged, and sterilized at the manufacturer's site. The method involves compressing the heart valve, packaging it in a sealed system while crimped, and sterilizing with electron beams. The leaflets are treated with a polyol solution before attaching to the frame. This avoids issues like fixative residue, calcification, and deformation that can occur with other sterilization methods.

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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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Packaging and sterilizing wet stored medical implants like heart valves that are delivered into the body via catheters. The implant is loaded into a portion of the delivery device and placed in a container filled with sterilizing fluid. The container is sealed and the assembly is moved along the delivery device to sterilize areas near the seals. This allows sterilization of both the implant and delivery device sections without drying out the implant.

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