US-20260123624-A1 - ACTIVE BIOLOGICAL SAMPLE PROCESSING AND THERMAL MANAGEMENT DEVICES

Abstract

Embodiments for a portable and compact centrifugation and thermal management system capable of separating and transporting biological samples while maintaining sample quality for periods of shipment time are described. A compact, automatic centrifuge holding exactly one sample tube is inside an insulating and thermally managed container suitable for standard shipping. A rotor to retain a sample tube is pre-balanced. An electronic controller starts, times and stops centrifugation automatically, responsive to placement of a lid. Thermal management may comprise a phase change material. Embodiments are free of user controls. Embodiments are free of the need for external power or external control.

Inventors

• Ulrich Schaff
• Angela Le
• Tifany Pan
• Kyungjin HONG
• Clara Neal

Assignees

• LABORATORY CORPORATION OF AMERICA HOLDINGS

Dates

Publication Date

20260507

Application Date

20250610

Claims (14)

1. 1 . An apparatus for blood sample separation and shipping comprising: a centrifuge comprising: a motor compartment, a rotor compartment and an axis of rotation; a centrifuge motor adapted to spin a rotor assembly around the axis of rotation via a motor shaft; an electronic controller operatively connected to the centrifuge motor; a battery; wherein the battery provides power to the centrifuge motor and to the electronic controller; wherein the rotor compartment comprises: a rotor assembly comprising: a rotor frame, a fixed counterweight, an attachment hub, and exactly one sample tube retainer; a safety liner effectively surrounding at least a portion of an interior perimeter of the rotor compartment; an outer container; a thermal insulation layer between the one sample tube retainer and the outer container; a thermally insulating lid comprising a thermal seal; and a thermal management assembly.
2. 2 . The apparatus of claim 1 further comprising: a lid sensor operatively connected to the electronic controller.
3. 3 . The apparatus of claim 1 wherein: the apparatus is free of manually operated controls and is free of a manually adjustable counterweight.
4. 4 . The apparatus of claim 1 wherein: the apparatus is free of manually operated buttons.
5. 5 . The apparatus of claim 1 wherein: the apparatus is free of a manual control for spin time and free of a manual control for spin speed.
6. 6 . The apparatus of claim 1 wherein: the apparatus is adapted to maintain a temperature of a sample tube placed in the one sample tube retainer between the range of 15° C. and 30° C. for a pre-determined time period.
7. 7 . The apparatus of claim 1 wherein: the thermal management assembly comprises a phase-change material.
8. 8 . The apparatus of claim 1 wherein: the thermal management assembly comprises a thermoelectric cooler.
9. 9 . The apparatus of claim 1 wherein: the one sample tube retainer is adapted to hold a sample tube at a fixed angle greater than 0 degrees and less than 20 degrees downward from a plane normal to the axis of rotation.
10. 10 . The apparatus of claim 1 wherein: the electronic controller comprises an automatic timer responsive to a lid sensor that controls a spin time of the motor in a predetermined time range of one minute to 120 minutes.
11. 11 . The apparatus of claim 1 wherein: the safety liner is adapted to protect against leakage from the a sample tube in the one sample tube retainer during spin of the centrifuge.
12. 12 . The apparatus of claim 1 wherein: the safety liner is adapted to protect against rupture of the safety liner during an internal pressure inside the safety liner of 95 kPA or less.
13. 13 . The apparatus of claim 1 wherein: the rotor assembly is configured such that a center of mass of the rotor assembly is within two mm of the axis of rotation when a sample tube comprising a predetermined sample volume is in the one tube retainer.
14. 14 . A method of preparing a blood sample for separation and shipping comprising the steps: (i) placing the blood sample in a sample tube; (ii) placing the sample tube in a rotor in a combined centrifugation and shipping apparatus adapted to hold exactly one sample tube; (iii) placing a lid on the apparatus, wherein a centrifuge in the apparatus automatically commences spinning; (iv) shipping the apparatus; wherein the method steps are free of manually balancing a centrifugation rotor, free of manual controls for setting a centrifugation spin rate, free of manual controls for setting a centrifugation spin time and free of setting of a temperature or temperature range.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 17/385,155, filed on Jul. 26, 2021, which claims the benefit of U.S. Provisional Application No. 63/056,909, filed on Jul. 27, 2020, which are incorporated herein by reference. BACKGROUND OF THE INVENTION This invention relates to processing and transport of biological specimens. One such biological specimen is whole blood, which may be processed by separation into plasma and cellular components. Processing and transport may be conducted in order to enable laboratory analysis such as diagnostic testing. Diagnostic testing may be conducted on biological samples such as blood and serum may. For diagnostic purposes, blood and serum may require a temperature range under which the fluids maintain their quality for diagnostic applications for a period of time. For example, serum may be stored at a temperature range of eight to 32° C. for a period of time of up to 48 hours. Alternately, serum may be stored at a temperature range of four to eight ° C. for a period of time of up to seven days. Alternately, serum may be frozen at a temperature range of −20° C. or lower for a period of time of up to one month. Whole blood may be stored at four to eight ° C., but only for 24 hours, and it cannot be frozen. Different samples may be kept at different temperature ranges, when used for different types of analysis. When a temperature range is not maintained, the sample's composition may change, particularly the composition of the liquid fraction may change thus giving inaccurate test results. Temperatures that are too low may generally result in damage to enveloped materials such as cells due to formations of intracellular ice, or may result in the formation of particulate matter due to aggregation of proteins and other dissolved substances. Elevated temperatures tend to accelerate degradation of proteins and enveloped materials such as cells due to faster chemical reactions at higher temperatures. Therefore, it is critical to implement a temperature regulation method to ensure that the sample composition remains stable when biological samples are to be shipped. Current thermal regulation methods for shipping can be impractical for certain users, as they require multiple of packaging and imposition of thermal moderators such as packs of frozen material. It is also difficult ensure the samples will be kept in ideal temperatures during the shipping process regardless of the external conditions during shipping such as hot or alternately freezing weather. Passive cooling approaches used alone may not allow for definite temperature control, as temperatures can fluctuate wildly in shipping vehicles. The cargo areas in the back of trucks can rise up to 60° C., causing similar shifts in temperature in packages contained within. In these cases, phase change material (PCM) such as water/ice, hydrated salts, paraffin waxes, and biological oils may be used to provide cooling or heating energy by the release or absorption of the thermal heat of fusion as appropriate in the vicinity of the temperature of the melting point of the PCM. Phase change materials may provide a thermal reserve against temperature change greater than passive materials relying solely on the thermal heat capacity. However, phase change materials may require active refrigeration or heating to achieve the desired phase state at the initial condition. For instance, a typical cold pack may require freezing by conventional refrigeration prior to its use in thermal regulation of packaged materials. Active refrigeration such as by Carnot cycle evaporation and condensation of a coolant, direct evaporative cooling, endothermic reactions, or thermoelectric cooling may also be used to provide active thermal regulation to samples in shipping. Prior art active coolant-cycle mediated refrigeration of shipped packages is typically conducted at the level of entire shipping containers such as a truck or shipping container. Such prior art cooling is expensive and may not cover the initial and final portions of a shipment, such as within a building or campus, or during inspection. Typical cold chain processing and shipment of a blood specimens require use of a centrifuge and refrigerated ice packs. Such equipment and skills are not available at many potential sites of blood draw due to power requirement, space, untrained users, and time. Prior art unpowered centrifuges, such as hand-crank operated spinners, do not provide the consistent spin rate and spin time performance required by regulations and standards for diagnostic testing. Prior art devices and their elements are generally single-use and not re-usable. Prior art devices and their elements are generally not sterilizable. SUMMARY OF THE INVENTION Embodiments enable remote blood separation. Without requiring an external power source, use in remote environments or emergency vehicles may be achieved. Although unpowered centri