The present disclosure relates to, at least, a vacuum-assisted method for infiltrating cadaver bone with a cryoprotectant and a method for rapidly warming the cryopreserved cadaver bone for bone marrow processing.

Provided is a gas fill fixture for use in lyophilization, a related system and method. The gas fill fixture includes a chassis, fill indicator and a lid, such that the chassis and lid together form a cavity for receiving a flexible lyophilization container. The system includes a lyophilization container, a lyophilizer and a gas fill fixture incorporating a chassis, a fill indicator and a lid. The method includes process steps for using the system to lyophilize a fluid.

In a method of ventilating excised lungs, a ventilation gas is supplied to an airway of a lung and a vacuum is formed around the lung. A quality of the vacuum is varied between a lower level and a higher level to cause the lung to breathe, while the pressure of the ventilation gas supplied to the airway is regulated to maintain a positive airway pressure in the airway of the lung. The vacuum may be cyclically varied between the two vacuum levels. The levels may be maintained substantially constant over a period of time, or one or both of the lower and higher levels may be adjusted during ventilation. The lung may be placed in a sealed chamber, and a vacuum is formed in the chamber around the lung.

A system comprises a fluid supply, a pressure regulator, a pressure valve, and a vent assembly. The fluid supply stores a volume of a fluid and is fluidly coupled to an outlet tube. The outlet tube is configured to be fluidly coupled to at least a portion of an organ environment. The organ environment configured to hold an organ. The pressure regulator is fluidly coupled to the outlet tube and is configured to maintain a fluid pressure of the fluid being supplied to the organ environment from the outlet tube. The fluid being supplied is at a pressure range above ambient to maintain the organ in an inflated position. The pressure valve is fluidly coupled to the outlet tube and inhibits increase of the fluid pressure above a threshold. The vent assembly removes excess fluid from the organ environment and includes a vent tube disposed within the organ environment and a vent valve disposed outside of the organ environment.

A device that can be used to store blood product and/or cellular culture that may or may not be under pressure. The device includes a chamber that can be hermetically sealed and a flexible secondary bag which can be placed in the chamber. The chamber is designed to receive at least one secondary bag that contains a conventional storage bag containing blood product and/or cellular culture. The storage conditions are created in the chamber and may or may not include 1) creating a pressure higher than atmospheric pressure, 2) creating a refrigerated temperature, and/or 3) providing agitation to the secondary bag. The secondary bag is filled with a gas system that is used to facilitate in the storage of the blood product and/or cellular culture. The secondary bag can be made of a material and/or include a coating or film that is impermeable to the gas system and to the gas inside the chamber. The higher-than-atmospheric pressure inside the chamber can be created by pumping an inexpensive gas, for example, air, into the chamber. The gas used to pressurize the chamber can be different from the gas system in the secondary bag.

In a method of ventilating excised lungs, a ventilation gas is supplied to an airway of a lung and a vacuum is formed around the lung. A quality of the vacuum is varied between a lower level and a higher level to cause the lung to breathe, while the pressure of the ventilation gas supplied to the airway is regulated to maintain a positive airway pressure in the airway of the lung. The vacuum may be cyclically varied between the two vacuum levels. The levels may be maintained substantially constant over a period of time, or one or both of the lower and higher levels may be adjusted during ventilation. The lung may be placed in a sealed chamber, and a vacuum is formed in the chamber around the lung.

A lung perfusion solution comprises a base solution comprising a physiological mixture of electrolytes and buffers, 3.5-5.5% (w/v) a first macromolecule having a molecular weight of 40-100 KDa, and an amount of a second, high molecular weight, macromolecule sufficient to adjust the relative viscosity of the solution to 2.0-3.0.

Provided is a loading tray assembly for housing a lyophilization container and a related system and method. The loading tray assembly includes a chassis including a contact void configured to facilitate direct contact between the attached lyophilization container and a lyophilizer shelf. The method includes securing a multi-part lyophilization container including a peelable seal on a lyophilization loading tray assembly, inputting a liquid into a non-breathable section of the lyophilization container, loading the tray assembly into a lyophilizer, freezing the liquid, applying heat energy and a vacuum, the vacuum causing an opening of the peelable seal and occluding the lyophilization container to isolate the frozen liquid.

Provided is a multi-part lyophilization container for lyophilizing a fluid, storing the lyophilizate, reconstituting the lyophilizate, and infusing the reconstituted lyophilizate into a patient, including a method of using same. The container includes a front surface, a back surface, a non-breathable section including a port region, a breathable section including a breathable membrane, and an occlusion zone encompassing a boundary between the non-breathable section and the breathable section. The non-breathable section is configured to accommodate any of a liquid, a solid, a gas or combination thereof. The breathable section is configured to accommodate only a gas. The method includes creating a temporary seal between the non-breathable section of the container and the breathable section, inputting a liquid into the non-breathable section, freezing the liquid, removing the temporary seal to allow vapor transport between the non-breathable section and the breathable section, and adding heat energy the frozen liquid under vacuum.

A body tissue preservation system for storage and preservation of body tissue, the system comprising a body tissue monitor to determine a status of the body tissue, wherein the body tissue monitor comprises: at least one sensor configured to obtain sensor data based on a plurality of measurements of the body tissue and/or the environment surrounding the body tissue; and a controller arranged to receive the sensor data from the at least one sensor, wherein the controller is configured to: detect one or more trigger events in the sensor data, wherein each trigger event comprises sensor data which satisfies a first threshold criterion; select, for each of the one or more trigger events, a window of the sensor data associated with the trigger event; identify, for each of the one or more windows, a subset of the sensor data corresponding to the selected window; determine, for each of the one or more selected windows, whether the corresponding identified subset of sensor data satisfies a second threshold criterion; determine a status of the body tissue based on identified subsets which satisfied the second threshold criterion; and provide a status output signal based on the determined status of the body tissue.