CN-122016611-A - Automated flow cytometry preparation and collection system and method of use thereof

CN122016611ACN 122016611 ACN122016611 ACN 122016611ACN-122016611-A

Abstract

A robotic system for automated sample preparation is provided. The system of interest includes a plurality of sample processing modules, a plurality of robotic components integrated with the sample processing modules, a processor including a memory operably coupled to the processor, wherein the memory includes instructions stored thereon that, when executed by the processor, cause the processor to control the sample processing modules and the robotic components so as to operate the sample processing modules and robotic components to prepare a plurality of samples for flow cytometry analysis, and an operable connection between the processor, the sample processing modules, and the plurality of robotic components. The system according to certain embodiments further comprises a flow cytometer, wherein the plurality of robotic components are further integrated with the flow cytometer, wherein the memory further comprises instructions stored thereon that, when executed by the processor, cause the processor to control the sample processing module, the robotic components, and the flow cytometer so as to load each prepared sample of the plurality of samples into the flow cytometer, and operate the flow cytometer to analyze each prepared sample of the plurality of samples, wherein the operable connection operably connects the processor, the sample processing module, the flow cytometer, and the plurality of robotic components. Methods of use and configuration or design of the system are also provided.

Inventors

R. V. Bashratyan
J. A. Chad
K. Devila
K. G. Birmingham

Assignees

贝克顿·迪金森公司

Dates

Publication Date: 20260512
Application Date: 20251112
Priority Date: 20241112

Claims (15)

1. A robotic system for automated sample preparation, the system comprising: a plurality of sample processing modules; A plurality of robotic assemblies integrated with the sample processing module; A processor including a memory operably coupled to the processor, wherein the memory includes instructions stored thereon that, when executed by the processor, cause the processor to control the sample processing module and the robotic assembly so as to: Operating the sample processing module and robotic assembly to prepare a plurality of samples for flow cytometry analysis, and An operative connection between the processor, the sample processing module, and the plurality of robotic components.
2. The system of claim 1, further comprising: A flow cytometer, wherein the flow cytometer is provided with a plurality of flow channels, Wherein the plurality of robotic assemblies are further integrated with the flow cytometer, Wherein the memory further includes instructions stored thereon that, when executed by the processor, cause the processor to control the sample processing module, the robotic assembly, and the flow cytometer to: loading a sample prepared from each of the plurality of samples into the flow cytometer, and Operating the flow cytometer to analyze each prepared sample of the plurality of samples, Wherein the operable connection operably connects the processor, the sample processing module, the flow cytometer, and the plurality of robotic components.
3. The system of any one of the preceding claims, wherein the system is configured to automatically prepare a plurality of samples for flow cytometry analysis.
4. The system of any one of the preceding claims, wherein the system is configured to automatically and continuously prepare a plurality of samples for flow cytometry analysis.
5. The system of any one of the preceding claims, wherein the system is configured to prepare a plurality of samples for flow cytometry analysis in an unattended manner.
6. The system of any one of the preceding claims, wherein the system is a robotic system for automated sample preparation and flow cytometry.
7. The system of any of the preceding claims, wherein the instructions comprise one or more of scheduling software, software for defining liquid treatment parameters, and software for defining system settings.
8. The system of any one of the preceding claims, wherein the plurality of sample processing modules are configured to prepare samples for flow cytometry analysis.
9. The system of any one of the preceding claims, wherein the plurality of sample processing modules comprises a stand alone laboratory device.
10. The system of any one of the preceding claims, wherein the plurality of modules comprises one or more of an antibody dilution module, a cell staining module, a sample washing module, a sample resuspension module, a sample movement module, and a sample analysis module.
11. The system of any one of the preceding claims, wherein the plurality of modules comprises one or more of an incubator, a storage unit, a cooler, a plate washer, a well washer, a compressor, a vacuum pump, a static rack, a bottle, a flow cytometer, a plate rotator, a bar code scanner, a plate storage device, a centrifuge, a hand-over rack, an automated liquid handling platform, a pipettor, a sample receiving area, a reagent receiving area, and a waste receiving area.
12. The system of any one of the preceding claims, wherein the plurality of modules comprises a flow cytometer configured to perform flow cytometry analysis on a sample prepared by the system.
13. The system of any of the preceding claims, further comprising a user interface.
14. The system of any of the preceding claims, further comprising a network interface.
15. A method of preparing a sample for flow cytometry analysis, the method comprising: Introducing a plurality of samples into a first sample processing module of a plurality of sample processing modules of a system, wherein the system comprises: the plurality of sample processing modules; A plurality of robotic assemblies integrated with the sample processing module; A processor including a memory operably coupled to the processor, wherein the memory includes instructions stored thereon that, when executed by the processor, cause the processor to control the sample processing module and the robotic assembly so as to: Operating the sample processing module and robotic assembly to prepare a plurality of samples for flow cytometry analysis, and An operative connection between the processor, the sample processing module, and the plurality of robotic components; Providing sample preparation instructions to the system, and The system is activated to automatically prepare a sample according to the sample preparation instructions.

Description

Automated flow cytometry preparation and collection system and method of use thereof Cross Reference to Related Applications According to 35 U.S. c. ≡119 (e), the present application claims priority from the filing date of U.S. provisional patent application serial No. 63/719,515 filed on day 2024, 11, 12, the disclosure of which is incorporated herein by reference in its entirety. Background Characterization of analytes in biological fluids has become an important part of biological research, medical diagnostics, and overall health assessment of patients. Detection of analytes in biological fluids (e.g., human blood or blood-derived products) may provide results that may play a role in determining treatment regimens for patients suffering from various conditions. Flow cytometry is a technique for characterizing and often sorting biological materials, such as cells of a blood sample or particles of interest in another biological or chemical sample. Flow cytometers typically include a sample reservoir for receiving a fluid sample (e.g., a blood sample) and a sheath fluid reservoir containing a sheath fluid. The flow cytometer delivers particles (including cells) in a fluid sample as a stream of cells to a flow cell while also directing sheath fluid to the flow cell. To characterize the composition of the flow stream, the flow stream is irradiated with light. Changes in the material in the flow stream (e.g., the presence of morphological or fluorescent markers) can result in changes in the observed light, and these changes can be used for characterization and separation. To characterize the composition in a flow stream, light must impinge on the flow stream and be collected. The light source in the flow cytometer may vary and may include one or more of a broad spectrum lamp, a light emitting diode, and a single wavelength laser. The light source is directed at the flow stream and collects and quantifies the optical response from the irradiated particles. Separation of biological particles is achieved by adding a sorting or collection function to the flow cytometer. Particles in the separation stream that are detected as having one or more desired characteristics are separated from the sample stream by mechanical or electrical removal. One common flow sorting technique utilizes droplet sorting in which a flowing stream containing linear separator particles is broken up into droplets. Droplets containing the particles of interest are charged and deflected into a collection tube by passing through an electric field. Typically, linear spacer particles in the stream are characterized as they pass through a viewpoint located directly below the nozzle tip. Once it is determined that a particle meets one or more desired criteria, it can be predicted when it will reach the drop separation point and separate from the stream in the form of a drop. Ideally, a short charge is applied to the flow stream immediately before the droplets containing the selected particles are separated from the flow stream, and then grounded immediately after the droplets are separated. The droplets to be sorted remain charged when they are detached from the flow stream, while all other droplets are uncharged. Typically, a sample (e.g., a biological sample) needs to be prepared, e.g., stained and/or washed, prior to characterization or other analysis of the sample by a flow cytometer. These preparation steps can be time consuming and labor intensive, thus requiring an operator or technician to perform or supervise these steps of sample preparation. Furthermore, these preparation steps performed or supervised by the skilled person may deviate from the final flow cytometry analysis results of such prepared samples. Disclosure of Invention The inventors have thus identified a need for a robotic system that enables fully automated sample preparation and fully automated flow cytometry analysis. In particular, there is a need for a modular robotic system that enables automated sample preparation for flow cytometry assays, providing an unattended solution for sample staining, washing and collection, and the ability to conduct multiple different experiments separately and simultaneously. Embodiments of the present disclosure address this need. Embodiments of the present disclosure address the limitations of the prior art by providing a completely unattended solution, namely a system configured to prepare and analyze flow cytometry samples without direct supervision or manipulation by a user. In addition, these improvements over the prior art may improve the consistency and accuracy of sample preparation and increase the efficiency and cost effectiveness of flow cytometry analysis of sample preparation and prepared samples. Aspects of the present disclosure include robotic systems for automated sample preparation. A system according to certain embodiments includes a plurality of sample processing modules, a plurality of robotic components integrated wi