Apparatus for tissue transport and preservation
Inventors
COLLETTE, Adam • Jessel, Melanie • Anderson, Lisa Maria
Assignees
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Publication Number
US-12310357-B2
Publication Date
2025-05-27
Expiration Date
Abstract
Systems and methods of the invention generally relate to prolonging viability of bodily tissue, especially an organ such as a lung, by adjusting pressure as needed to maintain a constant pressure within the organ even during external pressure fluctuations due, for example, to transportation of the organ in an airplane. Gas passing into and out of the organ may be conditioned to prolong tissue viability.
Core Innovation
The invention relates to extracorporeal lung storage that maintains a closed air system with a donor lung airway by directing gas through a channel into an airway of the lung using a pump. A lung adapter forms fluid communication between the channel and the airway so that the channel extends from an exterior of a container to an interior of the container. The container is configured to only allow gas to pass from the exterior of the container to the interior of the container through the channel.
To mitigate ambient pressure fluctuations due to altitude, the described system includes an expandable accumulator coupled to the closed air system and pressure regulation through pressure regulators and pressure relief valves. The expandable accumulator compliance is used to maintain nearly constant gauge pressure in the lung storage environment despite changes in ambient pressure, and the accumulator may be implemented using bellows-type accumulators, rolling diaphragm accumulators, constant force springs, spring-based accumulators, weight-based accumulators, or balloon-type accumulators.
The invention further includes sterile nested bags/containers and filtered connectors/ports to prevent contamination while venting leaked gas, and it conditions gas using in-line cooling and/or humidifying elements. Gas can be oxygenated, cooled, and/or humidified, including via an in-line humidifying element and an in-line cooling element, with eutectic cooling blocks and/or phase change material (PCM) pouches. Optional antimicrobial compounds can be added via humidifying liquid, and the system may also provide elastic sleeve compression and cyclic gas exchange for tissue viability and pleural-pressure emulation.
Claims Coverage
The document includes two independent claims: a system for storage of an organ and a method for storage of an organ. The claims share a common core structure that forms a closed air system linking a lung airway to a channel that only permits gas flow from the exterior of the container to the interior.
Closed air lung storage with pump-fed channel and lung adapter
A transport container includes a pump configured to direct gas through a channel into an airway of a lung, and a lung adapter in fluid communication with the channel to form a closed air system with the airway. The channel extends from an exterior of the container to an interior of the container, and the container is configured to only allow gas to pass from the exterior to the interior through the channel.
Relief valve releasing gas during pump gas delivery in the closed system
The system further includes a relief valve configured to release gas from the channel while the pump is directing gas through the channel.
Organ storage method using organ container forming a closed air system via channel and adapter
A method provides an organ container comprising a pump configured to direct gas through a channel into an airway of a lung, a relief valve configured to release gas from the channel while the pump is directing gas through the channel, and a lung adapter operable to form a closed air system with the airway. The channel extends from an exterior of the container to an interior of the container, and the method places the lung in the container and couples the airway to the lung adapter such that gas can only pass from the exterior to the interior through the channel, followed by placing the container in the organ container.
Across the independent claims, the main inventive features are the closed air system formed by a lung adapter and a channel that only permits exterior-to-interior gas flow, combined with a pump-directed gas delivery arrangement and a relief valve that releases gas from the channel while the pump is operating. The independent method claim mirrors the independent system claim’s closed air structural requirements and adds the coupling and placement steps for storage.
Stated Advantages
Maintains a nearly constant lung gauge pressure despite altitude-related ambient pressure fluctuations.
Reduces lung pressure/volume fluctuation relative to configurations without an accumulator (per described ideal-gas-based lung pressure-volume simulations).
Supports pressure maintenance under altitude/vibration conditions (per described ASTM 4169 altitude and vibration testing).
Documented Applications
Extracorporeal lung preservation/transport in which a donor lung is stored using a closed air system with nearly constant lung gauge pressure during transport.
Compatibility with hypothermic machine perfusion apparatus via separated perfusate circulation.
Pressure maintenance testing and modeling for lung storage systems, including ideal-gas-based lung pressure-volume simulations and benchtop pressure maintenance using leak-tested balloon/ET tube lung simulators.
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