Innovative Storage and Packaging Solutions for Prosthetic Heart Valves

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.

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 implant.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Bioprosthetic heart valve with an adaptive seal that minimizes perivalvular leakage following implantation. The valve has a biological tissue leaflet structure coupled to a supporting frame. An expandable material adaptive seal is coupled to the valve and expands after exposure to an initiating condition like contact with liquid. The packaged valve and seal do not contain a liquid storage solution. This allows the valve to be stored dry without encapsulating the adaptive seal. This prevents expansion and renders the valve unusable. The adaptive seal can be a hydrogel or coated wire that expands after contact with body fluids during implantation. This fills gaps between the valve and tissue for better sealing. The hydrogel can have biodegradable cross-links for delayed expansion.

A method for preserving biological tissues like collagenous heart valves without dehydration in a dry environment. The method involves immersing the tissues in a preservation liquid containing ionic liquids like quaternary ammonium salts or alkyl imidazolium salts. The ionic liquid replaces the intrinsic fluids in the tissues and maintains their size when removed. This allows direct storage, processing, sterilization, and implantation of the tissues without aqueous solutions. The ionic liquid preservation prevents dehydration and deformation when taken out of liquid.

Packaging system for bioprosthetic heart valves that allows easy loading onto catheters for minimally invasive implantation. The packaging involves sealing the valve in a fluid-filled container attached to the delivery catheter. During shipping, the valve is either pre-loaded onto the catheter or suspended in the container with an attachment mechanism that closes around the catheter. This prevents valve movement during transport. The sealed container with valve can then be loaded onto the delivery catheter by the clinician without rinsing or handling the valve separately. The container is removed before implantation.