Method for hypothermic transport of biological samples

Inventors

Macari, Danny • Whitney, Matthew • Estrella, Samantha • Churchill, William Lucas

Assignees

Paragonix Technologies Inc

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Publication Number

US-12709740-B2

Patent

Publication Date

2026-08-18

Expiration Date


Abstract

A method for transporting a biological sample at hypothermic temperatures. The container can be cooled using phase change material and pump fluid through the sample. The fluid can pump through the system at a rate independent of the parameters of the biological sample. A valve can control the rate of flow of the fluid into the biological sample.

Core Innovation

The disclosed invention is a system for preservation of a biological sample in a closed fluid system. A pump moves preservation fluid from a transport container through a fluid circuit to a biological sample adapter. A flow regulator valve regulates flow into the biological sample and releases fluid into the transport container based on a biological sample parameter, including vessel resistance, sample temperature, or flow rate through the sample.

The system supports hypothermic organ transport and maintains preservation beyond five hours without pump-parameter adjustment. Organ perfusion pressure is limited as vascular resistance and circuit pressure rise, without active pump adjustment, while reported deceased-donor kidney data show declining mean renal vascular resistance during perfusion. In addition to vessel resistance, sample temperature, and flow rate, organ pressure is identified as a parameter for regulating flow.

Claims Coverage

The claims identify two inventive features across two independent claims, covering a closed fluid system for biological sample preservation.

Closed fluid system with container-fed circuit and parameter-based flow regulation

Independent claim 1 covers a transport container and a pump configured to move preservation fluid from the container to a fluid-circuit inlet. A flow regulator valve regulates flow into the biological sample and releases fluid into the transport container at a rate based on a biological sample parameter, including vessel resistance, sample temperature, or flow rate through the sample. A biological sample adapter is in fluid communication with the inlet, and the fluid circuit forms a closed fluid system.

Closed fluid system with valve-fed circuit and organ pressure regulation

Independent claim 16 covers a transport container and a pump configured to move preservation fluid through a fluid circuit to a flow regulator valve. The valve regulates flow into the biological sample and releases fluid into the transport container at a rate based on a biological sample parameter, including vessel resistance, sample temperature, flow rate through the sample, or organ pressure. A biological sample adapter is in fluid communication with the valve, and the transport container and fluid circuit form a closed fluid system.

Both independent claims cover preservation-fluid delivery through a closed fluid system, with flow regulation and fluid release based on a biological sample parameter. The claims differ in their defined fluid paths, and claim 16 additionally identifies organ pressure as a regulation parameter.

Stated Advantages

The flow regulator valve maintains flow into the biological sample for preservation beyond five hours without adjusting pump parameters.

A pressure dampener reduces pulsation in the fluid circuit.

Documented Applications

Preservation and hypothermic transport of biological samples, including organs contained in a transport container and coupled with a biological sample adapter.

Perfusion of deceased-donor kidneys.

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