Apparatus, system and method for optical analysis of biological samples

Abstract

A system for optical analysis of biological samples is disclosed. This system can function as a point-of-care testing system and includes one or more analysis modules, each configured to receive a corresponding microfluidic disk and perform optical analysis on the corresponding biological sample. The system may include a housing, chassis and gantry unit, drawer, gripper, pipette, shaker, capping / removing device, multiple analysis modules, detection unit, thermal management unit, control unit, or any combination thereof.

Description

[0001] Cross-reference to related applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 591,603, filed on October 19, 2023, entitled “Devices, Systems and Methods for Optical Analysis of Biological Samples,” which is incorporated herein by reference in its entirety. Technical Field

[0002] This disclosure relates to devices, systems, and methods that allow for the execution of reactions and analyses of biological samples in microfluidic devices. Background Technology

[0003] Currently, 70% of all medical decisions rely on lab-based diagnoses, but the diagnostic process is now disconnected from how healthcare is delivered. Primary healthcare systems require patients to travel to external blood collection points, where the blood is then shipped to laboratories and processed overnight. This means that lab results don't reach healthcare professionals until long after the patient has left. This friction between healthcare delivery and disease management leads to enormous waste within the healthcare system. a. Patients frequently delay laboratory testing or fail to comply with laboratory testing or follow-up care advice; b. Gaps in the diagnostic process lead to missed detections, missed diagnoses, lack of intervention, and ultimately, poor outcomes; and c. Healthcare professionals waste time tracing lab orders back to patient records. When intervention is needed, additional time is wasted communicating with patients and advancing subsequent steps in their healthcare pathways.

[0004] These problems are even more pronounced when caring for patients in rural areas or those belonging to groups facing adverse social determinants of health, with numerous challenges in ensuring successful follow-up from the initial patient visit.

[0005] Several companies have built point-of-care testing instruments to bridge this gap. However, these instruments are limited to single types of tests and do not fully meet the workflow needs of primary care providers for a single system that produces simple, comprehensive, and rapid test results. Products are currently being developed to meet these needs. This is achieved through a highly automated workflow using microfluidics.

[0006] Furthermore, different reactions can have very different durations. For example, one endpoint assay might take less than a minute to run, while another might take more than 10 minutes. In many routine settings, all chemical reactions must be synchronized to complete simultaneously before measurements are performed. Additionally, different assays may rely on different wavelengths for illumination or detection. For a large number of assays, this can be very time-consuming and resource-intensive, and in some cases, impractical.

[0007] Therefore, there is still a need for improved devices, systems, and methods for performing large-scale reactions and analyses in parallel using microfluidics, thereby enabling user-friendly and instantaneous deployment of this technology. Summary of the Invention

[0008] In one embodiment, a system includes one or more analysis modules, each configured to receive a corresponding microfluidic disc and perform optical analysis on a corresponding biological sample. In some embodiments, the one or more analysis modules consist of a single analysis module. In some embodiments, the one or more analysis modules include multiple analysis modules. In some embodiments, the analysis modules among the multiple analysis modules can perform optical analysis independently or simultaneously with each other. In some embodiments, the multiple analysis modules can perform a full suite of tests.

[0009] In some embodiments, the one or more analysis modules include: a first analysis module configured to receive a first microfluidic disk and measure one or more hematological parameters; a second analysis module configured to receive a second microfluidic disk and perform an immunoassay; a third analysis module configured to receive a third microfluidic disk and perform a clinical chemistry analysis; or any combination thereof.

[0010] In some embodiments, the system includes: a gripper configured to transport a corresponding microfluidic disk to or from each of the one or more analytical modules; a holder configured to hold one or more sample tubes; a shaker configured to mix or homogenize one or more biological samples in the one or more sample tubes; a capping / uncapping device configured to remove caps from and / or recap sample tubes in the one or more sample tubes; and a drawer. A drawer is configured to receive consumables; a pipetting device is configured to pipette corresponding biological samples to corresponding microfluidic disks; a detection unit is configured to perform one or more of the following: detecting any microfluidic malfunctions on the microfluidic disks in each of the plurality of analysis modules; detecting the position of a gripper, holder, shaker, capping / uncapping device, drawer, or any combination thereof, thereby providing information for automatic calibration of the system; and performing one or more measurements; a thermal management unit is configured to maintain the system within a predetermined temperature range; or any combination thereof. In some embodiments, the detection unit includes one or more imaging cameras.

[0011] In some embodiments, the system includes: a housing including a door and a user interface; a chassis; and a gantry. In some embodiments, the system includes a control unit for operating a gripper, a holder, a shaker, a capping / removing device, a drawer, a pipetting device, multiple analysis modules, a detection unit, a thermal management unit, or any combination thereof. In some embodiments, the one or more analysis modules include at least three analysis modules powered by a single, unified architecture and capable of being implemented in a modular and streamlined platform. In some embodiments, corresponding biological samples are equally aliquoted into corresponding microfluidic disks for optical analysis.

[0012] In some embodiments, the system is configured to accept a single consumable kit per sample. In some embodiments, the one or more analysis modules are capable of providing multiple biomarker results. In some embodiments, the one or more analysis modules are capable of providing 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 30, 40, 50, 60, 70, 80, 90, 100, or more than 100 biomarker results. In some embodiments, the one or more analysis modules are capable of providing more than 5 biomarker results.

[0013] In some embodiments, optical analysis of corresponding biological samples is performed using a single workflow with user-selectable reports. In some embodiments, the system is automated. In some embodiments, the system is configured to accept one or more sample tubes, homogenize one or more biological samples contained in the one or more sample tubes, and analyze the homogenized one or more biological samples without any user intervention. In some embodiments, the system is configured to assess the quality of samples, reagents, and / or protocols. In some embodiments, the system is configured to transmit information about the quality of samples, reagents, and / or protocols using telemetry information. Attached Figure Description

[0014] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate one or more exemplary embodiments of the present disclosure and, together with the summary and detailed description, serve to explain the principles and implementation of the exemplary embodiments of the invention. The drawings are not necessarily drawn to scale. Specific design features of the invention disclosed herein (including, for example, specific dimensions, orientations, locations, and shapes) will be determined in part by the particular intended application and environment of use. Furthermore, the components illustrated in the figures can be combined in any useful number and combination. In all the figures, similar reference numerals denote similar elements.

[0015] In the attached diagram: Figure 1A This is a perspective view schematically illustrating a system according to some exemplary embodiments of the present disclosure; Figure 1B This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 1A An internal perspective view of the system; Figure 1C This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 1A Another perspective of the system's internal structure; Figure 1D This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 1A A top view of the system's interior; Figure 1E This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 1A A perspective view of some components of the system; Figure 1F It is a schematic diagram. Figure 1E A partial perspective view; Figure 1G It is a diagram. Figure 1F A magnified view of a portion; Figure 2A This is a perspective view schematically illustrating an exemplary gripper according to some exemplary embodiments of the present disclosure; Figure 2B This is an exploded view of the gripper in Figure 2A, which schematically illustrates some exemplary embodiments of the present disclosure. Figure 2C This is a schematic illustration of a first state according to some exemplary embodiments of the present disclosure. Figure 2A A cross-sectional view of the clamp; Figure 2D This is a schematic illustration of a second state according to some exemplary embodiments of the present disclosure. Figure 2A A cross-sectional view of the clamp; Figure 2E This is a schematic illustration of a third state according to some exemplary embodiments of the present disclosure. Figure 2A A cross-sectional view of the clamp; Figure 3A This is a perspective view schematically illustrating an exemplary drawer and some exemplary consumable packs and other components according to some exemplary embodiments of the present disclosure; Figure 3B This is a schematic illustration of a package without an exemplary consumables pack according to some exemplary embodiments of this disclosure. Figure 3A A perspective view of an exemplary drawer; Figure 3C This is a schematic illustration of an exemplary consumable package and some other components according to some exemplary embodiments of the present disclosure. Figure 3A An exploded view of an exemplary drawer; Figure 3D This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 3A An exploded view of some components; Figure 3E This is a perspective view of some components of Figure 3A, which schematically illustrates some exemplary embodiments of the present disclosure; Figure 3F This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 3A Perspective views of some components; Figure 3G This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 3A Perspective view of some components; Figure 3H This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 3A Another perspective view of some components of an exemplary drawer; Figure 3I , Figure 3J , Figure 3K and Figure 3L This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 3AAn exemplary perspective or side view of an exemplary drawer; Figure 3M and Figure 3N This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 3A A partial sectional view of some components of an exemplary drawer; Figure 3O , Figure 3P , Figure 3Q and Figure 3R This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 3A A top view of some components of an exemplary drawer; Figure 4A This is a perspective view schematically illustrating an exemplary rocker in a first state and some other components according to some exemplary embodiments of the present disclosure; Figure 4B This is a schematic illustration of a second state according to some exemplary embodiments of the present disclosure. Figure 4A A perspective view of an exemplary rocker and some other components; Figure 4C This is a schematic illustration of a first state according to some exemplary embodiments of the present disclosure. Figure 4A A side view of an exemplary rocker and some other components; Figure 4D This is a schematic illustration of a second state according to some exemplary embodiments of the present disclosure. Figure 5B A side view of an exemplary rocker and some other components; Figure 4E This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 4A A perspective view of an exemplary rocker and some other components; Figure 4F This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 4A A perspective view of an exemplary shaker, wherein an exemplary test tube rack is omitted for clarity; Figure 4G This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 4F An exploded view of an exemplary rocker; Figure 4H This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 4F Another exploded view of an exemplary rocker; Figure 4I This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 4A A perspective view of an exemplary rocker, wherein the cam surface does not rest against an external component; Figure 4J This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 4I A close-up view of the cam surface and external components; Figure 4K This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 4A A perspective view of an exemplary rocker, wherein the cam surface abuts against an external component; Figure 4L This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 4K A close-up view of the cam surface and external components; Figure 4M This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 4I A cross-sectional view of the position of the test tube holding component; Figure 4N This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 4J A cross-sectional view of the position of the test tube holding component; Figure 5A This is a perspective view schematically illustrating an exemplary capping / removing device according to some exemplary embodiments of the present disclosure; Figure 5B This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 5A Another perspective view of an exemplary capping / removing device; Figure 5C This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 5A An exploded view of an exemplary capping / removing device; Figure 5D It is a schematic diagram. Figure 5C An enlarged view of a portion of an exemplary capping / removing device.

[0016] Figure 5E This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 5A A cross-sectional view of an exemplary capping / removing device; Figure 5F This is a schematic illustration of some exemplary embodiments according to the present disclosure. Figure 5A An exemplary capping / uncapping device and a cross-sectional view of a sample tube; Figure 5G This is a schematic illustration of a housing positioned according to some exemplary embodiments of the present disclosure. Figure 5A A perspective view of an exemplary capping / removing device; Figure 5H and Figure 5IThis is a schematic illustration of sliding one or more covers in or out according to some exemplary embodiments of the present disclosure. Figure 5A A perspective view of an exemplary process of an exemplary capping / removing device; Figure 6 This is a perspective view schematically illustrating an exemplary detection unit and some other components according to some exemplary embodiments of the present disclosure; and Figure 7A , Figure 7B and Figure 7C This is a perspective view schematically illustrating an exemplary thermal management unit and some other components according to some exemplary embodiments of the present disclosure. Detailed Implementation

[0017] This disclosure provides apparatus, systems, and methods for running reactions in a microfluidic device to perform hematological analysis, immunoassay analysis, clinical chemistry analysis, or any combination thereof. In some embodiments, the system is capable of running a full suite of tests and can serve as a point-of-care testing system.

[0018] Exemplary System refer to Figure 1A-1D This illustration shows an exemplary system 100 according to some embodiments of the present disclosure. System 100 is configured to perform reactions and analyses of biological samples in a microfluidic device and can be used for hematological analysis, immunoassay analysis, clinical chemistry analysis, or any combination thereof. In some embodiments, system 100 is configured to run a full suite of tests. System 100 can act as a point-of-care testing system. System 100 includes one or more analysis modules, such as a first analysis module 110, a second analysis module 120, and / or a third analysis module 130. Each analysis module is configured to receive a microfluidic disk and analyze a biological sample, for example, to perform hematological analysis, immunoassay analysis, clinical chemistry analysis, or other analyses. In some embodiments, system 100 includes multiple analysis modules, each capable of performing analyses independently or simultaneously with each other. As a non-limiting example, the illustrated system 100 includes three analysis modules, such as a first analysis module 110, a second analysis module 120, and a third analysis module 130, one for hematological analysis (e.g., performing a complete blood count test), one for immunoassay analysis, and one for clinical chemistry analysis. In some embodiments, the first analysis module 110 is configured to receive a first microfluidic disk and perform hematological analysis.

[0019] The second analysis module 120 is configured to receive the second microfluidic disk and perform immunoassay analysis. The third analysis module 130 is configured to receive the third microfluidic disk and perform clinical chemistry analysis. Examples of such microfluidic disks and analysis modules are disclosed in the following U.S. provisional patent applications: U.S. Provisional Patent Application No. 63 / 489,667, filed March 10, 2023; U.S. Provisional Patent Application No. 63 / 489,677, filed March 10, 2023; U.S. Provisional Patent Application No. 63 / 489,681, filed March 10, 2023; U.S. Provisional Patent Application No. 63 / 514,965, filed July 21, 2023; U.S. Provisional Patent Application No. 63 / 514,973, filed July 21, 2023; and U.S. Provisional Patent Application No. 63 / 514,978, filed July 21, 2023, the contents of which are incorporated herein by reference in their entirety.

[0020] In some embodiments, system 100 includes one or more other components, modules, devices, or mechanisms, such as those disclosed herein. For example, in some embodiments, system 100 includes a chassis and gantry unit 150, a pipetting device 160, a gripper 200, a drawer 300, a sliding mechanism 400, a shaker 500, a tube holder 503, a capping / removing device 600, a detection unit 700, a thermal management unit 800, or any combination thereof. The one or more analytical modules, pipetting devices, drawers, grippers, holders, shakers, capping / removing devices, detection units, or any combination thereof may be housed in housing 140. In some embodiments, system 100 also includes a control unit for operating the gripper, holder, shaker, capping / removing device, drawer, pipetting device, one or more analytical modules, detection units, thermal management unit 800, or any combination thereof. The control unit may include one or more processors and a memory storing instructions that, when executed by the one or more processors, cause the system to perform one or more analyses. The control unit may be in the form of one or more printed circuit boards and may be housed within a housing or disposed outside the housing.

[0021] Housing 140 may include a user interface 142 to enable interaction between a user and system 100. For example, user interface 142 may be used to receive instructions from the user and / or display information related to the analysis. Housing 140 may also include a door 144 to allow at least a portion of drawer 300 to be moved into or out of the housing for placing or retrieving samples and / or other materials. Drawer 300 may be configured to receive consumables (e.g., microfluidic tray packs, reagent packs, pipette tip packs). An example of a consumable pack is disclosed in U.S. Provisional Patent Application No. 63 / 498,228, filed April 25, 2023, the contents of which are hereby incorporated by reference in their entirety.

[0022] The clamp 200 can be configured to transport the microfluidic tray to or from the analytical module. The tube holder 503 can be configured to hold one or more sample tubes. The shaker 500 can be configured to mix samples in the one or more sample tubes. The capping / uncapping device 600 can be configured to cap and / or recap the one or more sample tubes. The pipetting device 160 can be configured to pipe samples from the sample tubes to the microfluidic tray on the analytical module.

[0023] The chassis and gantry unit 150 can be configured to facilitate the movement of some parts in one or more directions. For example, the chassis and gantry unit 150 can be configured to allow the pipetting device 160 and the gripper 200 to move in three directions (e.g., along...). Figure 1C The drawer 300 can move in the x, y, and z directions. Alternatively, the chassis and gantry unit 150 may also be configured to allow at least a portion of the drawer 300 to move into and out of the housing 140 (e.g., slide in and slide out). Alternatively, the chassis and gantry unit 150 may also be configured to allow at least a portion of the test tube holder 503 to move into and out of the housing 140.

[0024] The pipetting device 160 and the gripper 200 can be interconnected and operably movable together in one or more directions. The pipetting device 160 and the gripper 200 can also be operably movable independently in one or more directions. For example, in some embodiments, the z-axis of the pipetting device 160 and the z-axis of the gripper 200 can be offset from each other along the x-direction, the y-direction, or both the x-direction and the y-direction, such as... Figure 1E-1G As illustrated in the figure. In some such embodiments, the pipetting device 160 and the gripper 200 can be operably moved independently of each other in the z-direction.

[0025] In some embodiments, system 100 is capable of running multiple different analysis methods, for example, performing analysis using multiple different analysis modules. In some embodiments, system 100 is capable of running two, three, four, five, or more than five different analysis methods. In some embodiments, system 100 is powered by a single and unified architecture and / or configured to implement a modular and streamlined platform. In some embodiments, system 100 is capable of running three different analysis methods in a modular and streamlined platform and is powered by a single and unified architecture.

[0026] In some embodiments, system 100 is configured to equally distribute samples into appropriate analytical methods.

[0027] In some embodiments, system 100 is configured to accept one or more consumable kits per sample. For example, in some embodiments, system 100 is capable of accepting a single consumable kit per sample, or accepting two or more consumable kits per sample.

[0028] In some embodiments, system 100 can provide one or more biomarker results. In some embodiments, system 100 can provide multiple biomarker results, including but not limited to 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 biomarker results. In some embodiments, system 100 can provide more than 5 biomarker results. In some embodiments, system 100 can provide at least some biomarker results simultaneously.

[0029] In some embodiments, system 100 is configured to perform an evaluation of biological samples using a single workflow with user-selectable reports.

[0030] In some embodiments, one or more processes are automated. For example, in some embodiments, system 100 is automated such that it can accept one or more sample tubes, homogenize the samples(s) in the one or more sample tubes, and make the homogenized samples available for evaluation without any user intervention.

[0031] In some embodiments, system 100 can use telemetry information to assess the quality of samples, reagents, and protocols. The telemetry information may include data measured by any sensor or camera disclosed herein or data received via telecommunications.

[0032] System 100 can be initiated by a user, for example, by scanning their badge or using user interface 142. In response, system 100 will open a door to allow the user to load sample tubes and consumables (e.g., microfluidic tray packs, reagent packs, pipette tip packs) into system 100 (e.g., drawers, tube holders). The user can then simply command system 100 to begin a test protocol, for example, via user interface 142. In response, drawer 300 will enter system 100, and door 144 will close. Holder 200 will pick up a tray and load it onto the corresponding analysis module. If more than one tray is present, holder 200 will pick up another tray and load it onto another analysis module. While holder 200 is picking up and loading trays, shaker 500 can begin shaking sample tubes to mix the samples. After mixing, one or more sample tubes are transferred to capping / uncapping device 600, which then uncapsulates the tubes. Pipette 160 picks up the pipette tip, collects the sample from the uncapped tube, and pipettes it to a corresponding microfluidic tray on the corresponding analytical module. The analytical module then performs analysis based on user input, barcodes on the sample tubes, barcodes on the consumables, or any combination thereof. Once analysis is complete, capping / uncapping device 600 can recap the tubes. Holder 200 picks up the trays and transports them back to the consumables in drawer 300. Door 144 can be opened, and drawer 300 and tube holder 503 can be removed from system 100 to allow the user to retrieve the sample tubes and consumables.

[0033] System 100 can function as a point-of-care testing system. For example, it can be placed in a primary care physician's office or any other suitable location. Upon arrival, the patient can provide a sample (e.g., blood), and a user (e.g., a physician's assistant, laboratory technician, or someone authorized to operate the system) can obtain the sample and use System 100 to analyze it (e.g., run a full suite of tests). All results are available when the patient is ready to see a physician, and the physician can review those results with the patient during the same visit.

[0034] Exemplary clamp refer to Figures 2A-2EThis illustration shows an exemplary gripper 200 according to some embodiments of the present disclosure. The gripper 200 is configured for picking up and / or transporting objects, such as a disc 260. The disc 260 may have an aperture 261, a step 262 along at least a portion of the perimeter of the aperture 261, and a disc surface 263. Examples of such discs are disclosed in the following U.S. Provisional Patent Applications: U.S. Provisional Patent Application No. 63 / 489,667, filed March 10, 2023; U.S. Provisional Patent Application No. 63 / 489,677, filed March 10, 2023; and U.S. Provisional Patent Application No. 63 / 489,681, filed March 10, 2023, the contents of which are hereby incorporated by reference in their entirety. The gripper 200 is more reliable, more stable, and more efficient than conventional grippers, particularly when gripping and / or transporting thin discs.

[0035] The gripper 200 generally includes a bench unit 210, a plurality of fingers 220, and a pushing unit 240. The bench unit 210 can be connected to a chassis and a gantry unit 150 and is operably movable within the system 100 in one or more of the x, y, and z directions. The bench unit 210 may include one or more components. For example, in some embodiments, the bench unit 210 includes a base 211 and a pivot plate 212 connected to (e.g., mounted on) the base 211. The base 211 can be configured to connect the gripper 200 to the chassis and gantry unit 150 of the system 100, such that the gripper 200 can be used to transfer microfluidic disks to or from analytical modules in the system 100. However, this disclosure is not limited thereto. The base 211 can be configured to connect the gripper 200 to any other structure or system, so that the gripper 200 can act as a stand-alone device or be used in other systems that require the transfer of objects.

[0036] The fingers of a plurality of fingers 220 are arranged circumferentially around a clamping axis 230, wherein a corresponding finger of the plurality of fingers 220 is pivotally connected to a bench unit 210 at its intermediate portion. For example, in the illustrated embodiment, each corresponding finger 220 is pivotally connected to a pivot plate 212 of the bench unit 210 at a corresponding pivot point 224, and thus becomes a first finger portion 221 and a second finger portion 222. In some embodiments, the second finger portion 222 of the corresponding finger 220 has a clamping portion 223. The clamping portion 223 may be formed along the second finger portion 222 at any suitable location and may have any suitable shape and / or size. In some embodiments, the clamping portion 223 is formed at the end of the second finger portion 222 of the corresponding finger 220. In some embodiments, the clamping portion 223 includes a hook. In some embodiments, the hook is oriented radially outward relative to the clamping axis 230.

[0037] The plurality of fingers 220 may include any suitable number of fingers, including but not limited to two, three, four, five, or more than five fingers. The fingers in the plurality of fingers 220 may (but not necessarily) be identical or symmetrical to each other, and may (but not necessarily) be uniformly spaced around the clamping axis 230. As a non-limiting example, Figure 2B The diagram shows three roughly identical finger-like objects, which are spaced roughly evenly around the clamping axis 230.

[0038] A push unit 240 is connected to a bench unit 210 (e.g., to the base 211 of the bench unit) and is configured to operate fingers 220 to grip or release objects. For example, in some embodiments, the push unit 240 includes a push member 241 generally aligned with a gripping axis 230. The push member 241 is operably movable relative to the bench unit 210 along the gripping axis 230, and therefore operably movable relative to the fingers 220 along the gripping axis 230, since the fingers 220 are mounted on a pivot plate 212 of the bench unit 210. As the push member 241 moves along the gripping axis 230, it selectively abuts outward against a first finger portion 221 or a second finger portion 222 of each corresponding finger 220, and thus causes the gripping portion 223 of each corresponding finger 220 to move inward or outward to grip or release an object (e.g., a disc 260). In some embodiments, the pusher member 241 acts as a cam surface.

[0039] The pushing member 241 may be made of multiple parts or segments. For example, in some embodiments, the pushing member 241 includes a first pushing portion 242 and a second pushing portion 243. When the pushing member 241 is in an environment such as... Figure 2CAt the first pushing position illustrated in the figure, the first pushing portion 242 abuts radially outward relative to the clamping axis 230 against the first finger portion 221 of each corresponding finger 220. This causes each corresponding finger 220 to rotate about the corresponding pivot point 224, thereby causing the clamping portion 223 of each corresponding finger 220 to move radially inward relative to the clamping axis 230. In this state, the clamping portions 223 of the plurality of fingers 220 can pass through the aperture 261 of the disk 260. For example, in some embodiments, the bench unit 210 is operably movable in a direction generally parallel to the clamping axis 230. By moving the bench unit 210 and / or the disk 260 toward each other, the clamping portions 223 of the plurality of fingers 220 can be inserted into the aperture 261 of the disk 260, as shown. Figure 2D As illustrated in the figure. Similarly, in this state, by moving the platform unit 210 and / or the disk 260 away from each other, the clamping portions 223 of the plurality of fingers 220 can be pulled out from the openings 261 of the disk 260.

[0040] When the gripping portions 223 of the multiple fingers 220 have been inserted into the openings 261 of the disk 260 and it is desired to pick up the disk 260, the pushing member 241 can move to, for example, Figure 2E The second pushing position is illustrated in the figure. At this second pushing position, the second pushing portion 243 abuts radially outward relative to the clamping axis 230 against the second finger portion 222 of each corresponding finger 220. This causes each corresponding finger 220 to rotate in opposite directions about its corresponding pivot point, thereby causing the clamping portion 223 of each corresponding finger 220 to move radially outward relative to the clamping axis 230. In this state, the clamping portions 223 of the plurality of fingers 220 engage with the step 262 of the disk 260, and thus clamp the disk 260. The disk 260 can then be transported to the desired location (e.g., the analysis module), for example, by moving the platform unit 210 via the chassis and the gantry unit 150.

[0041] The first pushing portion 242 and the second pushing portion 243 can take any suitable shape and size. In some embodiments, at least one of the first pushing portion 242 and the second pushing portion 243 is generally a frustocone. In some embodiments, each of the first pushing portion 242 and the second pushing portion 243 is generally a frustocone, with its base facing each other. In some embodiments, the second pushing portion 243 is smaller than the first pushing portion 242. In some embodiments, the first pushing portion 242 and the second pushing portion 243 are spaced apart from each other along the clamping axis 230. In some such embodiments, a portion of the pivot plate 212 is disposed between the first pushing portion 242 and the second pushing portion 243, and thus prevents the pushing member 241 from being completely removed from the internal space formed by the plurality of fingers 220.

[0042] In some embodiments, the actuating unit 240 includes a driving member 244 to move the actuating member 241. In some embodiments, the driving member 244 includes a solenoid having a housing connected to the bench unit 210 and a wire coil for operating the actuating member 241. In some embodiments, the driving member 244 includes a stepper motor or any other suitable linear actuator with one or more lead screws for actuating the member 241.

[0043] The gripper 200 may include additional, optional, or alternative components. For example, in some embodiments, the gripper 200 includes a reference unit 250 to help stabilize the disk 260 when it is gripped by a plurality of fingers 220. The reference unit 250 may be connected to the bench unit 210, such as the pivot plate 212 of the bench unit 210. When the disk 260 is gripped by the plurality of fingers 220, the reference unit 250 may form a corresponding contact 252 with the disk surface 263 and abut against the disk surface 263 in a direction generally parallel to the gripping axis 230. In this way, the reference unit not only helps stabilize the disk 260 but also helps level the disk 260.

[0044] Using the gripper 200 to transport objects is simple and efficient. For example, for transporting a tray 260, the gripper 200 can be moved to the location of the tray 260 (e.g., in a drawer 300 or an analytical module). If needed, the gripper 200 can be oriented such that the gripping axis 230 is substantially perpendicular to the tray surface 263 and / or substantially aligned with the orifice 261 of the tray 260. The push member 241 can be operated to press outward against the first finger portion 221 of each corresponding finger 220, such that the gripping portion 223 of each corresponding finger 220 moves radially inward relative to the gripping axis 230. The stage unit 210 can then be moved to insert the gripping portions 223 of the plurality of fingers 220 into the orifice 261 of the tray 260. Subsequently, the pushing member 241 can be moved to abut against the second finger portion 222 of each corresponding finger, causing the clamping portion 223 of each corresponding finger 220 to move radially outward relative to the clamping axis 230 and engage with the step 262 of the disk 260. While the clamping portions 223 of the plurality of fingers 220 are engaged with the step 262 of the disk 260, the platform unit 210 can be moved to lift the disk 260 and transport it to any desired position. When the disk 260 is transported to the desired position, the pushing member 241 can be operated again to abut against the first finger portion 221 of each corresponding finger 220. This causes the clamping portion 223 of each corresponding finger 220 to move radially inward relative to the clamping axis 230 and disengage from the step 262 of the disk 260. Then, the platform unit 210 can be moved to pull out the clamping portions 223 of the plurality of fingers 220 from the openings 261 of the disk 260.

[0045] Exemplary drawer refer to Figure 3A-3LThis illustration shows an exemplary drawer 300 and other components according to some embodiments of the present disclosure. The drawer 300 is configured to receive and store consumables, such as tray pouch 301 and support pouch 302, and / or other pouches or components. The tray pouch 301 may include a housing 310 and one or more items 311 packaged within the housing 310. The one or more items 311 may be a microfluidic tray configured for hematological analysis (e.g., for complete blood count testing), a microfluidic tray for immunoassay analysis, a microfluidic tray for clinical chemistry analysis, and urine test strips, or any combination thereof. The microfluidic tray may have orifices, steps, and a tray surface (similar to those of tray 260) such that it can be gripped and transported using a gripper 200. The support pouch 302 may include a housing 320 and one or more items 321 packaged within the housing 320. The one or more items 321 may include, for example, one or more reagents, one or more pipette tips, or any combination thereof. Additional information regarding consumables and consumable packages can be found in U.S. Provisional Patent Application No. 63 / 498,228, filed on April 25, 2023, the contents of which are incorporated herein by reference in their entirety.

[0046] Especially for reference Figures 3A-3B as well as Figure 3E-3F Drawer 300 includes a drawer nesting unit 303 having one or more drawer shelves, each drawer shelf being configured to receive a consumable pack. For example, in some embodiments, the drawer nesting unit 303 includes a first drawer shelf 330 configured to receive a tray pack 301 and a second drawer shelf 340 configured to receive a support pack 302. However, this disclosure is not limited thereto. The drawer nesting unit 303 may have a single drawer shelf, or it may have three, four, five, or more than five drawer shelves. In some embodiments, the first drawer shelf 330 and the second drawer shelf 340 are formed as a single piece. In some embodiments, the entire drawer nesting unit 303 is formed from a single piece.

[0047] In some embodiments, a respective drawer insert in one or more drawer inserts includes an insert slot, an insert opening, and an insert frame. The insert slot is generally formed at the front of the drawer nesting unit to allow a corresponding bag to be inserted into the corresponding drawer insert. The insert opening is generally formed at the top of the drawer nesting unit to allow access to one or more items contained in the corresponding bag. The insert frame is formed above the corresponding bag to prevent the outer shell of the corresponding bag from moving upwards.

[0048] For example, in some embodiments, the first drawer insert 330 includes an insert groove 331, an insert opening 332, and an insert frame 333. The insert groove 331 is generally formed on the front side of the drawer nesting unit 303 to allow a tray 301 to be inserted into the first drawer insert 330. The insert opening 332 is generally formed on the upper side of the drawer nesting unit 303 to allow access to one or more items 311 (e.g., trays) contained in the tray 301. In some embodiments, the insert opening 332 is generally circular or its shape generally matches the shape of the tray(s). The insert frame 333 is formed above the tray 301 to prevent the outer casing 310 of the tray 301 from moving upward. Once the tray 301 is inserted into the first drawer insert 330; once testing begins, when the item 311 is retrieved from the tray 301; or at any other programmed time, the insert frame 333 can be actuated, for example, by an actuator to restrict upward movement of the tray 301.

[0049] Similarly, in some embodiments, the second drawer insert 340 includes an insert groove 341, an insert opening 342, and an insert frame 343. The insert groove 341 is generally formed on the front side of the drawer nesting unit 303 to allow the support package 302 to be inserted into the second drawer insert 340. The insert opening 342 is generally formed on the upper side of the drawer nesting unit 303 to allow access to one or more items 321 (e.g., reagents, pipette tips) contained in the support package 302. The insert frame 343 is formed above the support package 302 to prevent the outer shell 320 of the support package 302 from moving upward. Once the support package 302 is inserted into the first drawer insert 330; once testing begins, when the item 311 is retrieved from the support package 302; or at any other programmed time, the insert frame 343 can be actuated, for example, by an actuator to restrict upward movement of the support package 302.

[0050] Drawer inserts may include additional, optional, or alternative components. For example, particularly referencing... Figure 3B , Figure 3E and Figure 3F In some embodiments, the first drawer insert 330 includes an insert base 334 having an insert retaining member 335. The insert retaining member 335 is configured to engage with a retaining member 312 of the outer casing 310 of the tray 301 to restrict rotation of the outer casing 310 of the tray 301 relative to the first drawer insert 330. In this way, the tray(s) contained in the outer casing 310 can be easily and precisely located and retrieved, for example, by a gripper 200. The insert retaining member 335 and the retaining member 312 can have any regular or irregular shape, including but not limited to polygons and ovals. As a non-limiting example, the insert retaining member 335 and the retaining member 312 are shown in a generally triangular shape.

[0051] In some embodiments, the first drawer insert 330 includes an insert camera 336 configured to retrieve information from a barcode on the outer casing 310 of the tray 301. This information may relate to the number of trays(s) in the tray 301, the type of test to be performed on each tray, and / or any other information. The insert camera 336 can be positioned anywhere corresponding to the location of the barcode on the outer casing 310 of the tray 301. For example, if the barcode is located at the bottom of the outer casing 310 of the tray 301, the insert camera 336 can be positioned at the insert base 334. The insert camera does not need to be directly looking at the barcode. In some embodiments, if size constraints exist, a mirror can be placed between the insert camera 336 and the barcode location.

[0052] Especially for reference Figure 3N-3R In some embodiments, the first drawer insert 330 includes an insert position sensor 337 and an indicator 338. The insert position sensor 337 is configured to detect the position of the tray 301 within the first drawer insert 330. Based on the detection result of the insert position sensor 337, the indicator 338 indicates whether the tray 301 is correctly positioned within the first drawer insert 330. Once the tray 301 is inserted into the first drawer insert 330, and before testing begins, the detection and indication of the position of the tray 301 can occur. The indicator 338 can indicate whether the tray 301 is correctly positioned within the first drawer insert 330 visually, audibly, or both visually and audibly. For example, the indicator 338 can use one or more lights (e.g., light-emitting diodes) to indicate whether the tray 301 is correctly positioned within the first drawer insert 330 by color and / or flashing. In some embodiments, the indicator 338 may be indicated by a first color (e.g., yellow) for any incorrect position (e.g., disk 301 not fully inserted), by a second color (e.g., red) for an incorrect disk 301 (e.g., an expired disk), and / or by a third color (e.g., white) for the correct position (e.g., disk 301 is correctly placed). The indicator 338 may be positioned on the front or top side of the first drawer insert 330, or in any other suitable location visible to the user. As a non-limiting example, one indicator 338 may be shown on the front of the first drawer insert 330, and another indicator 338 may be shown below the disk. In some embodiments, the insert camera 336 acts as an insert position sensor.

[0053] Similarly, in some embodiments, the second drawer insert 340 includes an insert position sensor 344 and an indicator 345. The insert position sensor 344 is configured to detect the position of the support package 302 within the second drawer insert 340. Based on the detection result of the insert position sensor 344, the indicator 345 indicates whether the support package 302 is correctly positioned within the second drawer insert 340. Once the support package 302 is inserted into the second drawer insert 340, and before testing begins, the detection and indication of the position of the support package 302 can occur. The indicator 345 can indicate whether the support package 302 is correctly positioned within the second drawer insert 340 visually, audibly, or both visually and audibly. For example, the indicator 345 can use one or more lights (e.g., light-emitting diodes) to indicate whether the support package 302 is correctly positioned within the second drawer insert 340 by color and / or flashing. In some embodiments, the indicator 345 may be indicated by a first color (e.g., yellow) to indicate any incorrect position (e.g., support package 302 is not fully inserted), by a second color (e.g., red) to indicate an incorrect support package 302 (e.g., an expired support package), and / or by a third color (e.g., white) to indicate the correct position (e.g., support package 302 is correctly placed). The indicator 345 may be located on the front or top side of the second drawer insert 340, or in any other suitable location visible to the user. As a non-limiting example, the indicator 345 is shown on the front of the second drawer insert 340.

[0054] Especially for reference Figures 3A-3D In some embodiments, drawer 300 includes drawer structure unit 304 having a drawer base 350 configured to mount drawer nesting unit 303. In some embodiments, drawer base 350 includes a body 351, a first member 352 at the front of the body 351, and a second member 353 at the rear of the body 351. The first member 352 and the second member 353 may be fixed to or formed together with the body 351. Alternatively or additionally, drawer base 350 may be configured to mount one or more other components, such as locating members (e.g., locating markers and sensors) for detecting the position of the drawer and / or other components of the system, and cam members 363 and 364 for engaging with other components of the system.

[0055] In some embodiments, drawer 300 includes one or more drawer rails 305 and one or more drawer rail carriages 306 to allow drawer chassis 350 to slide along one or more drawer rails 305. One or more drawer rails 305 and one or more drawer rail carriages 306 may be disposed adjacent to door 144 in housing 140 such that at least a portion of drawer 300 can be removed from housing 140 to allow loading and unloading of consumables. Alternatively, in some embodiments, drawer 300 may not include rails or rail carriages; instead, drawer structural unit 304 is configured for engagement with rails adjacent to door 144 in housing 140.

[0056] Especially for reference Figure 3G-3L In some embodiments, roller 307 is connected to a first member 352 of drawer base 350. Door 144 is connected to housing 140 or base and gantry unit 150 by one or more spring hinges. Door 144 is rotatable relative to housing 140 about door hinge axis 371. Drawer base 350 is slidable in a direction generally perpendicular to door hinge axis 371. Because drawer roller 307 is connected to the first member 352 of drawer base 350, drawer roller 307 is able to move with drawer base 350 and is rotatable about roller rotation axis 372 generally parallel to door hinge axis 371. When drawer base 350 slides toward the door, drawer roller 307 rolls on the inner surface of the door and thus pushes the door open. When drawer base 350 slides away from the door, the one or more spring hinges pull and close the door. Drawer base 350 may slide toward the door in response to a command from a user (e.g., by scanning their badge to start a test) or when the test is completed. The drawer base 350 can slide away from the door in response to user commands or when the correct positioning of the consumable is detected. With the help of rollers 307, opening and closing the door is simple, smooth, and reliable.

[0057] Exemplary test tube holders and test tube shakers refer to Figure 4A-4NThis illustration shows an exemplary test tube shaker 500 and some other components according to some embodiments of the present disclosure. The test tube shaker 500 is configured to shake (e.g., rotate or oscillate) any sample test tube 501 to mix the sample contained in the sample test tube 501. The test tube shaker 500 generally includes a test tube holder 503, a shaker mounting unit 504, a shaker shaft 505, and a shaker drive unit 506. The test tube holder 503 is configured to hold one or more sample test tubes 501. The shaker shaft 505 has a rotation axis 551 and is rotatably mounted on the shaker mounting unit 504. In some embodiments, the shaker shaft 505 is configured to be fixedly connected to the test tube holder 503. A shaker drive unit 506 is connected to a shaker shaft 505 and is configured to rotate the shaker shaft 505 about its axis of rotation 551 in both clockwise and counterclockwise directions between positive angles (e.g., α) and negative angles (e.g., -α). This shakes the test tube holder 503 and any sample test tubes 501 held by the test tube holder 503 between positive angles (e.g., α) and negative angles (e.g., -α). Figures 4A-4D As illustrated in the figure. In some embodiments, the maximum permissible angle is at least 50 degrees. o At least 60 o At least 70 o At least 80 o At least 90 o At least 100 o At least 110 o or at least 120 o In some embodiments, the maximum permissible angle is up to 160 degrees. o At most 150 o At most 140 o At most 130 o At most 120 o At most 110 o or at most 100 o .

[0058] Shaking can be performed, for example, at a controlled speed, controlled acceleration, controlled deceleration, controlled frequency, controlled number of times, or any combination thereof. The control of shaking can be determined based on the type of sample contained in one or more sample tubes and / or the test to be performed. In some embodiments, shaking is performed to drive any air bubbles downward to the bottom of the tube without causing any adverse effects on the sample (e.g., without causing greater shear stress on the cells of the sample).

[0059] Especially for reference Figure 4E-4NIn some embodiments, the tube holder 503 includes a rack 530 having one or more rack slots 531, each rack slot 531 configured to receive a tube body 511 of a sample tube 501. For illustration, three slots and three tubes are shown. However, this disclosure is not limited thereto. The rack 530 may have any suitable number of slots, including but not limited to one, two, three, four, five, or more than five slots. Furthermore, each slot may contain, but does not necessarily have to contain, any sample tube 501. For example, if the test requires only a single sample tube, two of the three slots will not contain any sample tubes. If the test requires two sample tubes, one of the three slots will not contain any sample tubes. Additionally, multiple sample tubes may (but do not necessarily have to) be placed in the tube holder 503 in any particular order. For example, in some embodiments, the tube shaker 500 or system 100 may include a detection unit configured to distinguish one sample tube from another. A non-limiting example is that the cap 512 of sample tube 501 can be different colors to indicate different types of samples (e.g., blood or urine) or anticoagulants (e.g., anticoagulants for hematology, or anticoagulants for immunoassays or clinical chemistry) in sample tube 501. The detection unit can detect the color and determine which slot contains which type of sample. This reduces user error.

[0060] The cap 512 of each sample tube 501 may be disposed outside the corresponding slot of the rack 530 and connected to the tube body 511 by interference fit, etc. The rack 530 has at least a partial opening at a first side 532. This allows access to at least a portion of the tube body 511 of the sample tube 501 housed in any of the one or more slots 531.

[0061] In some embodiments, the test tube holder 503 further includes a holder shaft 533 disposed adjacent to a first side 532 of the holder 530. For example, in some embodiments, the holder 530 and the holder shaft 533 are mounted on a holder body 534, wherein the first side 532 of the holder 530 faces the holder shaft 533.

[0062] In some embodiments, the tube holder 503 further includes one or more retaining units 535. Each of the one or more retaining units 535 is associated with a corresponding slot in one or more slots 531 of the rack 530. For example, as a non-limiting example, three retaining units 535 are illustrated, each corresponding to one of the three slots 531. Each corresponding retaining unit 535 is configured to retain the tube body 511 of the sample tube 501 in the corresponding slot 531 of the rack 530. In some embodiments, the corresponding retaining unit 535 includes a tube retaining member 536 and a holder resilient member 538. The tube retaining member 536 is rotatably disposed at the holder axis 533 and includes an edge on the side facing the first side 532 of the rack 530. In some embodiments, the tube retaining member 536 of each retaining unit 535 is rotatable about the holder axis 533. The retainer elastic member 538 biases the test tube holding member 536 to push the edge against the test tube body 511 of the sample test tube 501 housed in the corresponding rack slot 531, thereby holding the test tube body 511 of the sample test tube 501 in the corresponding rack slot 531 of the rack 530.

[0063] The edge 537 of the test tube holding member 536 can have any suitable shape and size. For example, the edge 537 of the test tube holding member 536 can be a wedge, blade, knurled surface, etc., that can provide frictional contact with the test tube body 511. The retainer elastic member 538 can be any suitable type that can provide the necessary force to the test tube holding member 536. For example, in some embodiments, the retainer elastic member 538 is a coil spring with a first end connected to the holder 530 or a stationary component and a second end connected to (e.g., abutting against) the test tube holding member 536.

[0064] In some embodiments, one or more shelf slots 531 include multiple shelf slots, and one or more holding units 535 include multiple holding units. In some embodiments, the multiple shelf slots include at least three shelf slots, and the multiple holding units include at least three holding units. In some embodiments, the tube holder 503 is configured to receive a first sample tube containing a first type of blood, a second sample tube containing a second type of blood, a third sample tube containing urine, or any combination thereof. The first type of blood may be EDTA-anticoagulated blood. The second type of blood may be heparin lithium-anticoagulated blood. In some embodiments, the tube holder 503 may be configured to hold one or more sample tubes of smaller diameter (e.g., microcapsules) via a tube adapter. For example, a small sample tube may be inserted into a tube adapter, and then the adapter, along with the sample tube, may be inserted into the tube holder 503 and / or other devices / mechanisms and used in a manner similar to that of sample tube 501.

[0065] Especially for reference Figure 4I-4N The test tube holder 503 may include one or more cam surfaces configured to engage / disengage the edge 537 of the test tube holding member 536 of each holding unit 535 with any sample test tube 501 already inserted into any rack slot 531 of the rack 530. For example, in some embodiments, the test tube holder 503 includes a holder cam surface 539 connected to a holder shaft 533 and configured to abut against an external component 521. This causes the test tube holder 503 to rotate, and thus disengages the edge 537 of the test tube holding member 536 of each holding unit 535 from the sample test tube 501 already inserted into the corresponding rack slot 531. For example, as Figure 4I , Figure 4J and Figure 4M As illustrated, when the retainer cam surface 539 is not against the external component 521, the retainer elastic member 538 biases the test tube holding member 536 of each holding unit 535 such that the edge 537 of the test tube holding member 536 engages with the sample test tube 501 already inserted into the corresponding shelf slot 531. The engagement of the edge 537 of the test tube holding member 536 of each holding unit 535 with the sample test tube 501 provides the necessary frictional force to hold the sample test tube 501 in the corresponding shelf slot 531. This prevents the sample test tube 501 from slipping out of the shelf 530 during shaking or other processes. Figure 4K , Figure 4L and Figure 4N As illustrated, when the retainer cam surface 539 abuts against the external component 521, it causes the tube holder 503 to rotate, causing the edge 537 of the tube holding member 536 of each holding unit 535 to disengage from the sample tube 501 already inserted into the corresponding rack slot 531. This provides clearance that allows easy insertion and removal of sample tube(s) into and from the rack 530. The external component 521 may be mounted on the drawer base 350, at or adjacent to the first component 352 or any other suitable location.

[0066] Especially for reference Figure 4E-4H In some embodiments, the shaker mounting unit 504 includes mounting members 542 spaced apart in a direction generally parallel to the axis of rotation 551. A shaker shaft 505 is rotatably connected to the mounting members 542. As a non-limiting example, the illustrated shaker shaft 505 is rotatably connected to the mounting member 542. A test tube holder 503 is disposed on the mounting member 542 and is connected to the shaker shaft 505, for example, via a holder body 534.

[0067] The shaker drive unit 506 includes a shaker motor 561 connected to a shaker shaft 505. The shaker motor 561 can be any suitable type of motor, including but not limited to a stepper motor. In some embodiments, the shaker motor 561 is a stepper motor, and the shaker shaft 505 is the rotor shaft of the stepper motor. In some embodiments, the shaker drive unit 506 also includes a connector configured to selectively connect the shaker shaft 505 to a test tube holder 503. The shaker motor 561 is operable to rotate the shaker shaft 505 about its axis of rotation 551 clockwise and counterclockwise between positive angles (e.g., α) and negative angles (e.g., -α). Therefore, if the test tube holder 503 is connected to the shaker shaft 505, this shakes the test tube holder 503 and any sample test tubes 501 held by the test tube holder 503 between positive angles (e.g., α) and negative angles (e.g., -α). Figures 4A-4D As shown in the diagram.

[0068] The shaker 500 or shaker drive unit 506 may include one or more additional or optional components to facilitate the shaking of the test tube holder 503 and any sample test tubes 501 held by the test tube holder 503 in a controlled and / or safe manner. For example, additionally or optionally, the shaker drive unit 506 may include a shaker stop 575, a shaker stop guide 571, a limit switch 572, a limit switch mark 573, or similar components, or any combination thereof, to set limits on the swing angle to prevent the swing from exceeding the limits, to switch the direction of rotation when the set limits are reached, or any combination thereof. The shaker stop 575, the shaker stop guide 571, the limit switch 572, and / or the limit switch mark 573 may be disposed at or adjacent to the mounting member 542 of the mounting unit 504. Alternatively, the rocker drive unit 506 may include an encoder 574 to provide a feedback signal by tracking the speed and / or position of the rocker shaft 505. The encoder 574 may be mounted on the rocker motor 561 and configured to track the speed and / or position of the rocker shaft 505 and provide a feedback signal.

[0069] Especially for reference Figure 4EIn some embodiments, the shaker 500 includes a shaker sensing unit 508 configured to detect the position of one or more sample tubes contained in the tube holder 503, determine whether any of the one or more sample tubes 501 is incorrectly positioned, or both. The shaker sensing unit 508 may include one or more sensors 581 disposed below the shaker shaft 505. In some embodiments, the shaker sensing unit 508 includes at least one sensor 581 corresponding to each of the one or more rack slots 531. For example, in the illustrated embodiment, the shaker sensing unit 508 includes three sensors 581, one sensor corresponding to each of the three rack slots 531, and is configured to detect the position of a sample tube 501 that has been inserted into the corresponding rack slot 531.

[0070] Exemplary capping / removing device refer to Figure 5A-5I This illustration shows an exemplary capping / uncapping device 600 according to some exemplary embodiments of the present disclosure. The capping / uncapping device 600 is configured to uncap one or more test tubes (such as sample tubes 501) after the samples have been properly mixed by the shaker 500 or at any other desired time. In some embodiments, the capping / uncapping device 600 is also configured to recap one or more test tubes, for example, after sample use, after testing is completed, or at any other desired time. In some embodiments, the capping / uncapping device 600 is capable of simultaneously uncapping multiple sample tubes and / or simultaneously recapping multiple sample tubes. However, it should be noted that the capping / uncapping device 600 may (but not necessarily) operate at full capacity. For example, in embodiments where the capping / uncapping device 600 is capable of simultaneously uncapping three sample tubes, the capping / uncapping device 600 may be operated to uncap a single sample tube, to uncap two sample tubes at a time, or to uncap all three sample tubes simultaneously.

[0071] Capping / removing device 600 includes a cap holding unit 601 for receiving one or more caps 512. In some embodiments, the cap holding unit 601 includes a first segment 611 and a second segment 612. The first segment and the second segment are aligned along a first cap remover direction (e.g., Figure 5A The caps (in the y-direction) are spaced apart from each other and together form a channel 613. Channel 613 allows one or more caps (such as one or more caps 512 of one or more sample tubes 501 contained in the tube holder 503) to slide into cap holding unit 601. The sliding of the caps into cap holding unit 601 is generally along a second cap removal direction that is substantially perpendicular to the first cap removal direction (e.g., ...). Figure 5A(in the x direction). (One or more) of the cover entering the cover holding unit 601 can slide, for example, as follows: Figure 5H and Figure 5I The sliding mechanism 400 disclosed herein is used as illustrated in the figure. The sliding of one or more covers into the cover holding unit 601 can also be implemented such that, where desired (e.g., considering a particular application and / or process), only a subset of the covers (e.g., in…) slide into the cover holding unit 601. Figure 5H and Figure 5I In the middle, one or two of the three caps slide into channel 613, or until the cap of each sample test tube contained in the test tube holder slides into channel 613.

[0072] Especially for reference Figure 5A as well as Figure 5D-5F In some embodiments, the first segment 611 is formed or joined to a first shoulder 615 on the side of the first segment 611 facing the channel 613. The first shoulder 615 is configured to allow a first portion of the underside of one or more covers to rest on the first shoulder 615. Similarly, in some embodiments, the second segment 612 is formed or joined to a second shoulder 616 on the side of the second segment 612 facing the channel 613 (e.g., the first shoulder and the second shoulder face each other). The second shoulder 616 is configured to allow a second portion of the underside of one or more covers to rest on the second shoulder 616.

[0073] In some embodiments, the first shoulder 615 has one or more first recesses 617, each recess 617 being configured to accommodate a first portion of a cap. In some embodiments, the first shoulder 615 has a plurality of first recesses 617 (e.g., 2, 3, 4, 5, or more than 5 recesses) arranged along a second cap remover direction. Similarly, in some embodiments, the second shoulder 616 has one or more second recesses 618, each second recess 618 being configured to accommodate a second portion of a cap. Each of the one or more recesses of the second shoulder 616 is generally aligned with a corresponding recess of the one or more recesses of the first shoulder 615 along the first cap remover direction. In some embodiments, the second shoulder 616 has a plurality of second recesses 618 (e.g., 2, 3, 4, 5, or more than 5 recesses) arranged along a second cap remover direction.

[0074] In some embodiments, the first and second shoulders allow any cap 512 to be placed on the first and second shoulders by gravity once separated from the test tube body (e.g., decapped). When the cap is placed on the first and second shoulders, the first and second shoulders are aligned along a third cap removal direction that is substantially perpendicular to both the first and second cap removal directions (e.g., Figure 5A z-direction or Figure 5F(Vertically) abutting against the underside of one or more caps. In some embodiments, once any cap is removed from the sample tube, the first shoulder and the second shoulder hold any cap in place. In some embodiments, during cap removal (e.g., when pulling the cap upward), the first shoulder and the second shoulder act as stoppers to prevent the tube body 511 from moving upward.

[0075] The capping / removing unit includes one or more cap centering units 603, each configured to center a cap 512 in the appropriate position within the channel 613 according to a center plane 614 of the channel 613. In some embodiments, each of the one or more cap centering units 603 is aligned along a first cap remover direction with a first notch 617 on a first shoulder 615 and a second notch 618 on a second shoulder 616. The one or more cap centering units 603 help to correctly position any cap 512 once it slides into the channel 613, and thus ensure effective and reliable capping / removing of the sample tube(s).

[0076] The capping / removing unit may include any suitable number of cap centering units 603, including but not limited to one, two, three, four, five, or more than five cap centering units. In embodiments where multiple cap centering units are present, the cap centering units 603 are arranged along the direction of the second cap remover. The cap centering units 603 may (but not necessarily) be identical to each other. As a non-limiting example, three substantially identical cap centering units 603 are illustrated.

[0077] In some embodiments, the cap centering unit 603 includes a first gripper 631 and a second gripper 632. The first gripper 631 is disposed at the first segment 611 of the cap holding unit 601, above the first shoulder 615, and is slidable relative to the first segment 611 in a first cap remover direction (e.g., Figure 5E (It slides back and forth from left to right). The second gripper 632 is located at the second section 612 of the cap holding unit 601, above the second shoulder 616, and can slide relative to the second section 612 in the direction of the first cap remover.

[0078] In some embodiments, the cap centering unit 603 further includes a first centering elastic member 633 and a second centering elastic member 634. The first centering elastic member 633 is configured to push a first gripper 631 toward the central plane 614 of the channel 613 along the first cap remover direction, and the second centering elastic member 634 is configured to push a second gripper 632 toward the central plane 614 of the channel 613 along the first cap remover direction. By moving from opposite sides of the central plane 614 toward the central plane 614 of the channel 613, the first and second grippers help align the cap 512 with the central plane 614 of the channel 613.

[0079] A first centering elastic member 633 may be disposed at or fixedly connected to the first segment 611. For example, in some embodiments, the first centering elastic member 633 is a leaf spring, one end portion of which is fixedly connected to the first segment 611, and the other end portion abuts against the first gripper 631 toward the center plane 614 of the channel 613. Similarly, a second centering elastic member 634 may be disposed at or fixedly connected to the second segment 612. For example, in some embodiments, the second centering elastic member 634 is a leaf spring, one end portion of which is fixedly connected to the second segment 612, and the other end portion abuts against the second gripper 632 toward the center plane 614 of the channel 613.

[0080] The cap holding unit 601 or cap centering unit 603 may include additional or optional components. For example, in some embodiments, the cap holding unit 601 includes a third segment 620 formed or coupled to the first and second segments. The third segment 620 may be disposed on top of the first and second segments, with the first and second grippers located between the first and second segments. This ensures smooth movement of the first and second grippers (e.g., preventing movement of the first and second grippers along a third cap remover direction). In some embodiments, the third segment 620 is configured to limit the sliding movement of the first gripper 631 of each cap centering unit 603 relative to the first segment 611 and / or the sliding movement of the second gripper 632 of each cap centering unit 603 relative to the second segment 612 to one or more defined ranges.

[0081] For example, in some embodiments, the first gripper 631 has a first groove 635. The third segment 620 has a first protrusion 621, which is smaller than the first groove 635 in the first cap remover direction. When the first protrusion 621 is inserted into the first groove 635, a first space 637 exists between the first protrusion 621 and the first groove 635. This first space 637 defines the sliding range of the first gripper 631. Similarly, the second gripper 632 has a second groove 636. The third segment 620 has a second protrusion 622, which is smaller than the second groove 636 in the first cap remover direction. When the second protrusion 622 is inserted into the second groove 636, a second space 638 exists between the second protrusion 622 and the second groove 636. This second space 638 defines the sliding range of the second gripper 632.

[0082] In some embodiments, the cap holding unit 601 is connected to the head unit 604 and is slidable relative to the head unit 604 in a first cap remover direction. For example, in some embodiments, the head unit 604 includes a first member 641, a guide rail 642, and a carriage 643. The first member 641 may include one or more return springs. The guide rail 642 is connected to the first member 641, and the carriage 643 is slidably coupled to the guide rail 642. A third segment 620 of the cap holding unit 601 is connected to the carriage 643. This allows the cap holding unit 601 to move relative to the head unit 604 in a first cap remover direction (e.g., Figure 5E (Move left or right), thereby achieving overall adjustment in the event that any cap 512 is significantly offset from the center plane 614 of the channel 613. In some embodiments, the capping / removing device 600 includes a head unit 604 (e.g., the head unit is a component of the capping / removing device 600). In some embodiments, the head unit 604 is an external component of the capping / removing device 600 (e.g., a component of the system 100).

[0083] In some embodiments, the cap holding unit 601 is connected to a drive unit 605, which may be a component of the capping / removing device 600 or a component external to the capping / removing device 600 (e.g., a component of system 100). The drive unit 605 is configured along a third cap removal direction that is substantially perpendicular to both the first cap remover direction and the second cap remover direction (e.g., Figure 5A z-direction or Figure 5E The drive unit 605 (moving the cap holding unit 601 and / or the head unit 604 from top to bottom) includes, in some embodiments, a motor 651, a guide rail 652, a guide rail carriage 653, a first mounting member 654, and a second mounting member 655. The first mounting member 654 may be configured to mount the cap holding unit 601, the head unit 604, and / or the guide rail carriage 653. The first mounting member 654 may also include a lead screw nut bracket for coupling with the motor 651. The second mounting member 655 may be configured to mount the guide rail 652, wherein the guide rail carriage 653 is slidably coupled to the guide rail 652. The second mounting member 655 may be connected to other structures, such as the chassis and gantry unit 150 of system 100. The motor 651 is operable via the first mounting member 654 to move the cap holding unit 601 and / or the head unit 604 along the guide rail 652 (e.g., along a third cap remover direction). Since the tube body 511 of each sample tube 501 is held, for example, by the tube holder 503, the movement of the cap holder 601 along the direction of the third cap remover will cause each sample tube 501 that has slid into the channel 613 of the cap holder 601 to be capped or decapped.

[0084] The capping / removing device 600 may include one or more additional or optional components to facilitate the capping or removal of the sample tube 501 in a controlled and / or safe manner. For example, in some embodiments, the capping / removing device 600 may include a switch marker 661 and a switch 662 to indicate the position of the cap holding unit 601 and / or set the range of movement of the cap holding unit 601. Switch marker 661 may be connected to a first mounting member 654, and switch 662 may be connected to a second mounting member 655, or vice versa.

[0085] Exemplary detection unit refer to Figure 6 This illustration shows an exemplary detection unit 700 according to some exemplary embodiments of the present disclosure. The detection unit 700 (or one or more components of the detection unit) may be stationary, for example, fixedly connected to the chassis and gantry unit 150 or any other stationary unit / module / device of system 100. The detection unit 700 (or one or more components of the detection unit) may also be movable, for example, movably connected to the chassis and gantry unit 150 or any other movable unit / module / device connected to system 100. For example, in some embodiments, the detection unit 700 includes one or more imaging cameras, and at least one camera is positioned at the gripper 200 and is movable with the gripper 200. This allows the camera to move within system 100 along all three axes and to reach any location of interest. The camera may have a large field of view. In some embodiments, the detection unit 700 includes a plurality of cameras that may be placed at different locations within system 100, or may be moved to different locations simultaneously or at any time specified in the test. In some embodiments, the detection unit 700 includes one or more lamps for illuminating the area of ​​interest without illuminating other parts of the system 100.

[0086] The detection unit 700 can be configured to perform multiple functions. For example, the detection unit 700 can be configured to detect microfluidic faults occurring in analytical modules (e.g., the first analytical module 110, the second analytical module 120, or the third analytical module 130). The detection unit 700 can capture images of certain portions of the disk in the analytical module and analyze those images to determine whether a fault has occurred based on certain identified critical fault patterns. In some embodiments, the detection unit 700 can be configured to detect microfluidic faults occurring in each of these analytical modules. The detection unit 700 can also be configured to detect certain critical locations within the system 100, such as the chassis and gantry unit 150, the pipetting device 160, the gripper 200, the drawer 300, and / or other critical locations of units / modules / devices. Detection of certain critical locations can be based on a static reference placed in the system 100 and act as an automatic calibration tool with minimal user input. The detection unit 700 can also be configured to perform certain measurements. For example, in some embodiments, sample tube 501 contains a urine sample, and consumables (e.g., tray 301) include one or more urine test strips. The urine sample may be placed on one or more urine test strips, for example, by pipetting device 160. The urine sample may change color or cause color shifts on one or more urine test strips, which can be detected by detection unit 700. In some embodiments, detection unit 700 is configured to: (i) detect any microfluidic malfunctions on the microfluidic disk in each of a plurality of analysis modules; (ii) detect the position of a holder, retainer, shaker, capping / uncapping device, drawer, or any combination thereof, thereby providing information for automatic calibration of the system; and (iii) perform one or more assays, or any combination thereof.

[0087] Exemplary thermal management unit refer to Figures 7A-7C This illustration shows an exemplary thermal management unit 800 according to some exemplary embodiments of the present disclosure. The thermal management unit 800 can be configured to maintain the system 100 within a predetermined temperature range specified in a test. In some embodiments, the thermal management unit 800 includes one or more intake fans 810 and one or more exhaust fans 820. The one or more intake fans may be located at the bottom of the system 100. In some embodiments, one or more support legs 830 are also located at the bottom of the system 100 to create space for the one or more intake fans 810 to draw in fresh air. The one or more exhaust fans may be located on one side (such as the rear) of the system 100.

[0088] In some embodiments, the thermal management unit 800 includes one or more guiding units 840, each guided unit 840 configured to guide airflow to a specific area within the system 100. For example, a heat sink 850 may be present in the system 100. The heat sink 850 may be a printed circuit board or part of a printed circuit board. The guiding unit 840 may be configured to guide airflow to the heat sink 850 or its surrounding area to effectively cool the heat sink 850. In some embodiments, the guiding unit 840 includes a first member 841 and a pair of second members 842. The first member 841 may be in the form of a plate, skin, etc., and may be made of a material such as sheet metal or injection-molded plastic. The first member 841 may be arranged in such a way that a gap is formed between the first member 841 and the housing 140. The pair of second members 842 may be in the form of ribs, etc., thereby forming channels to guide airflow to the heat sink 850 or its surrounding area. In some embodiments, the pair of second members 842 also serve as structural elements for supporting the first member 841.

[0089] Some embodiments or implementations are described with reference to the following entries: Item A1. A gripper comprising: Bench unit; Multiple finger-like structures, among which: The fingers among the plurality of fingers are arranged circumferentially around the clamping axis; Each corresponding finger of the plurality of fingers is pivotally connected to the bench unit at its intermediate portion, thereby dividing each corresponding finger into a first finger portion and a second finger portion; and The second finger portion of each corresponding finger has a clamping portion; and A pushing unit connected to a bench unit and including a pushing member aligned with a clamping axis, wherein the pushing member is operably movable relative to the bench unit along the clamping axis to selectively abut outward against a first finger portion or a second finger portion of each corresponding finger, thereby causing the clamping portion of each corresponding finger to move inward or outward in order to clamp or release an object.

[0090] Item A2. The clamp according to item A1, wherein: The object is a disc, which includes an opening and a step along at least a portion of the perimeter of the opening. The clamping portion of each corresponding finger is formed at the end of the second finger portion of each corresponding finger; When moved inward, the gripping portion of the multiple fingers can pass through the aperture of the disk; and When moved outward, the gripping portion of the multiple fingers can engage with the steps of the disc to hold the disc.

[0091] Item A3. The gripper according to Item A2, wherein the bench unit is operably movable in one or more directions, including a gripper direction generally parallel to the gripping axis.

[0092] Item A4. The gripper according to Item A3, wherein the plurality of fingers comprises two, three, four, five, or more than five fingers.

[0093] Item A5. The gripper according to Item A4, wherein the fingers of the plurality of fingers are spaced substantially evenly around the gripping axis.

[0094] Item A6. The gripper according to Item A5, wherein the fingers of the plurality of fingers are substantially the same as each other.

[0095] Item A7. The gripper according to Item A6, wherein the gripping portion of each corresponding finger includes an outwardly facing hook.

[0096] Item A8. The gripper according to Item A7, wherein the pushing unit includes a driving member to move the pushing member.

[0097] Item A9. The gripper according to Item A8, wherein the pushing member comprises: The first pushing portion, when the pushing member is in the first pushing position, abuts outward against the first finger portion of each corresponding finger, thereby causing the clamping portion of each corresponding finger to move inward; and The second pushing part, when the pushing member is in the second pushing position, abuts against the second finger portion of each corresponding finger, thereby causing the clamping portion of each corresponding finger to move outward.

[0098] Item A10. The gripper according to Item A9, wherein the first or second pushing portion is substantially a truncated cone.

[0099] Item A11. The gripper according to item A10, wherein the bottoms of the first pushing portion and the second pushing portion face each other.

[0100] Item A12. The gripper according to item A11, wherein the second pushing portion is smaller than the first pushing portion.

[0101] Item A13. The gripper according to item A12, wherein the first pushing portion and the second pushing portion are spaced apart from each other along the gripping axis.

[0102] Item A14. The gripper according to item A13, further comprising: One or more supports are connected to the bench unit and are configured to abut against an object to help stabilize the object when it is held by the plurality of fingers.

[0103] Item A15. The gripper according to item A14, wherein: The object is a disk, which includes a disk surface that is generally perpendicular to the clamping axis; and The one or more supports include a plurality of reference supports arranged circumferentially around the clamping axis and located radially outside the plurality of fingers, each of the plurality of reference supports abutting the disk surface in a direction generally parallel to the clamping axis.

[0104] Item A16. The gripper according to Item A15, wherein the plurality of reference pillars comprises two, three, four, five, or more than five reference pillars.

[0105] Item A17. A method for transporting a disc including an orifice and at least a portion of a step along the perimeter of the orifice, the method comprising: Provide a clamp as described in entry A1; The push member is operated to abut against the first finger portion of each corresponding finger outward, thereby causing the clamping portion of each corresponding finger to move inward; The movable platform unit is used to insert the clamping portion of the plurality of fingers into the aperture of the disk; and The pusher is operated to abut against the second finger portion of each corresponding finger, thereby causing the clamping portion of each corresponding finger to move outward and engage with the step of the disc.

[0106] Item A18. The method according to item A17 further includes: The mobile platform unit is equipped with a lifting plate.

[0107] Item A19. The method according to item A18 further includes: The movable platform unit is used to transport the tray to the desired location.

[0108] Item B1. A retainer comprising: A rack including one or more rack slots, wherein: Each of the one or more rack slots is configured to accommodate a test tube body for receiving one or more sample test tubes; and The rack has at least a partial opening on a first side to allow access to at least a portion of the test tube body of a sample test tube contained in any of the one or more rack slots; A retainer shaft is provided adjacent to the first side of the frame; One or more retaining units, each retaining unit being associated with a corresponding rack slot in the one or more rack slots of the rack, and comprising: A test tube holding member, rotatably disposed at the retainer shaft, and including an edge on the side facing the first side of the holder; and A retainer elastic member biases the test tube holding member to push the edge against the test tube body of the sample test tube housed in the corresponding rack slot, thereby holding the test tube body of the sample test tube in the corresponding rack slot.

[0109] Item B2. The retainer according to claim B1, wherein: The one or more rack slots include multiple rack slots; and The one or more holding units include multiple holding units.

[0110] Item B3. The retainer according to claim B2, wherein: The plurality of rack slots includes at least three rack slots; and The plurality of holding units includes at least three holding units.

[0111] Item B4. The retainer according to Item B3, wherein the one or more sample tubes comprise: The first sample tube containing the first type of blood; The second sample tube containing the second type of blood; A third sample tube containing urine; or Any combination thereof.

[0112] Item B5. The retainer according to Item B4, wherein: Type I blood is blood anticoagulated with ethylenediaminetetraacetic acid (EDTA); and The second type of blood is heparin lithium anticoagulated blood.

[0113] Item B6. The holder according to Item B5, wherein the tube holding member of each of the plurality of holding units is rotatable independently about the holder axis.

[0114] Item B7. The holder according to Item B6, wherein each sample tube includes a cap disposed outside the corresponding slot of the rack.

[0115] Item B8. The retainer according to Item B7, wherein: The tube is connected to the test tube body by interference fit; Cover with color coding; or Both.

[0116] Item B9. The retainer according to Item B8, wherein the edge of the tube retaining member is a wedge or blade.

[0117] Item B10. The holder according to Item B9, wherein the elastic member of the holder is a helical spring, the first end of which is connected to a frame or stationary component, and the second end of which is connected to a test tube holding component.

[0118] Item B11. The retainer according to item B10, further comprising: A first retainer cam surface, which is connected to a retainer shaft and configured to engage with a first external component to rotate the retainer, thereby disengaging the edge of the tube holding member of each of the one or more holding units from the sample tube in each of the one or more slots of the insert holder.

[0119] Item B12. The retainer according to item B10, wherein: The retainer elastic member pushes the test tube holding member toward the first side of the rack, thereby engaging the edge of the test tube holding member with the sample test tube inserted into the corresponding rack slot.

[0120] Item C1. A rocker comprising: Shaker mounting unit; A shaker shaft having a rotation axis and rotatably mounted on a shaker mounting unit, wherein the shaker shaft is configured for fixedly connecting a holder containing one or more sample tubes; A shaker drive unit is connected to a shaker shaft and configured to rotate the shaker shaft about its axis of rotation in a clockwise and counterclockwise direction between positive and negative angles, thereby shaking a holder containing one or more sample tubes.

[0121] Item C2. The shaker according to Item C1, wherein the retainer is the retainer according to Item B1.

[0122] Item C3. The shaker according to item C2, wherein: The rocker mounting unit includes a first mounting member and a second mounting member, which are spaced apart in a direction generally parallel to the axis of rotation; The rocker shaft is rotatably connected to the first mounting member; and The retainer is disposed between the first mounting member and the second mounting member.

[0123] Item C4. The rocker according to Item C3, wherein the rocker drive unit comprises: The crank motor; and A connector that selectively connects the rocker shaft to the retainer.

[0124] Item C5. The rocker as described in Item C4, wherein the rocker motor is a stepper motor.

[0125] Item C6. The rocker according to Item C4, wherein the rocker drive unit further comprises: A lock, operable to selectively engage with the connector to prevent unwanted rotation of the retainer.

[0126] Item C7. The shaker according to Item C6, wherein: The connector includes a notch; and The lock includes: The plug-in portion that can be inserted into the notch of the connector; and A cam surface configured to engage with an external component to push the plug-in portion into a notch in the connector, or to pull the plug-in portion out of the notch.

[0127] Item C8. The rocker as described in Item C7, wherein the lock is activated in response to the detection of a fault to engage with the connector.

[0128] Item C9. The rocker as described in Item C8, wherein the lock is activated by a spring.

[0129] Item C10. The shaker as described in Item C8, wherein the faults include: The holder is tilted beyond a predetermined angle.

[0130] Item C11. The shaker according to item C1 further includes: A shaker sensing unit configured to detect the position of one or more sample tubes contained in a holder.

[0131] Item C12. The shaker according to Item C11, wherein the shaker sensing unit is configured to further determine whether any of the one or more sample tubes is incorrectly positioned.

[0132] Item C13. The rocker as described in Item C12, wherein the rocker sensing unit includes one or more sensors disposed below the rocker shaft.

[0133] Item C14. A rocker according to any one of items C1-C13, wherein the rocker drive unit is configured to cause the rocker shaft to rotate about its axis of rotation in a controlled speed, controlled acceleration, controlled deceleration, controlled frequency, controlled number of times, or any combination thereof in a clockwise and counterclockwise direction.

[0134] Item D1. A capping / removing device comprising: The cover retaining unit includes: First paragraph; The second segment is spaced apart from the first segment along the direction of the first cap remover; The channel, which is between the first and second sections, is configured to allow one or more caps of one or more sample tubes contained in the retainer to slide into the cap retainer unit in a second cap remover direction that is generally perpendicular to the first cap remover direction. A first shoulder, located on the channel-facing side of the first section, and configured to allow a first portion of the underside of one or more covers to rest on the first shoulder; and The second shoulder is located on the channel-facing side of the second section and is configured to allow the second portion of the underside of one or more covers to rest on the second shoulder. One or more cap centering units, each cap centering unit comprising: The first gripper is disposed at the first section of the cap holding unit, above the first shoulder, and is slidable relative to the first section along the direction of the first cap remover. A first centering elastic member, wherein the first centering elastic member is biased toward the center plane of the channel along the direction of the first cap remover; The second gripper is disposed at the second section of the cap holding unit, above the second shoulder, and is slidable relative to the second section along the direction of the first cap remover; and The second centering elastic member has a second gripper offset towards the center plane of the channel along the direction of the first cap remover. This allows the cover, which has already slid into the channel, to be centered in the appropriate position based on the center plane of the channel.

[0135] Item D2. The capping / removing device according to Item D1, wherein the cap holding unit is connected to the head unit and is slidable relative to the head unit in a first cap remover direction.

[0136] Item D3. The capping / removing device according to Item D2, wherein the head unit is a component of the capping / removing device.

[0137] Item D4. The capping / removing device according to Item D2 or D3, wherein the head unit is an external component of the capping / removing device.

[0138] Item D5. A capping / removing device according to any one of items D1-D4, wherein: Each of the first shoulder and the second shoulder includes one or more notches; and Each of one or more notches of the first or second shoulder is aligned with the cap centering unit along the direction of the first cap remover and is configured to hold a cap in the one or more caps.

[0139] Item D6. A capping / removing device according to any one of items D1-D5, wherein a first shoulder and a second shoulder abut against the underside of one or more caps along a third capping direction substantially perpendicular to both the first capping direction and the second capping direction, thereby facilitating the capping or removal of the one or more sample tubes.

[0140] Item D7. A capping / removing device according to any one of items D1-D6, wherein once any cap is removed from a sample tube in the one or more sample tubes, a first shoulder and a second shoulder retain the cap.

[0141] Item D8. The capping / removing device according to any one of items D1-D7, wherein the cap holding unit further comprises: The third segment, which forms or connects with the first and second segments, is configured to limit the sliding range of the first or second gripper of each of one or more cover centering units relative to the first or second segment.

[0142] Item D9. A capping / removing device according to any one of items D1-D8, wherein the one or more cap centering units comprise: Multiple cap centering units are arranged along the direction of the second cap remover.

[0143] Item D10. The capping / removing device according to Item D9, wherein the plurality of cap centering units include: Two, three, four, five, or more than five centering units.

[0144] Item D11. A capping / removing device according to any one of items D1-D10, wherein for each of the one or more cap centering units: The first centering elastic member is fixedly connected to the first segment; and The second centering elastic member is fixedly connected to the second segment.

[0145] Item D12. A capping / removing device according to any one of items D1-D11, wherein for each of the one or more cap centering units: The first or second centering elastic component is a leaf spring.

[0146] Item D13. The capping / removing device according to any one of items D1-D12, further comprising: A drive unit connected to a cap holding unit and configured to move the cap holding unit along a third capping direction that is substantially perpendicular to both the first and second capping directions, thereby capping or removing the caps from each of one or more sample tubes that have slid into the channel of the cap holding unit.

[0147] Item E1. A drawer comprising: One or more drawer inserts, each drawer insert configured to accommodate a bag including a housing and one or more items within the housing, wherein each respective drawer insert of the one or more drawer inserts includes: The drawer has a front insert groove that allows a corresponding bag to be inserted into the corresponding drawer insert. A recessed opening on the upper side of the drawer allows access to one or more items contained in the corresponding bag; and The corresponding upper frame is used to prevent the outer shell of the corresponding bag from moving upwards.

[0148] Item E2. The drawer according to Item E1, wherein each of the one or more drawer layers further comprises: A drawer position sensor, used to detect the position of a corresponding compartment within a drawer drawer; and An indicator is used to indicate whether the corresponding package is correctly positioned in the corresponding drawer compartment based on the detection results of the compartment position sensor.

[0149] Item E3. The drawer as described in Item E2, wherein an indicator visually, audibly, or both visually and audibly indicates whether the corresponding package is correctly positioned in the corresponding drawer compartment.

[0150] Item E4. The drawer as described in Item E3, wherein an indicator is color-coded to indicate whether the corresponding package is correctly positioned in the corresponding drawer compartment.

[0151] Item E5. A drawer according to any one of items E2-E4, wherein an indicator is provided on the front or upper side of the respective drawer insert.

[0152] Item E6. A drawer according to any one of items E2-E5, wherein the one or more drawer inserts comprise: A first drawer insert, configured to accommodate a first package including one or more microfluidic disks, wherein the insert opening of the first drawer insert is generally circular; and The second drawer insert is configured to accommodate a second package including one or more reagent wells and one or more pipetting tips.

[0153] Item E7. The drawer as described in Item E6, wherein the one or more microfluidic disks include: The first microfluidic disk is configured for use in complete blood cell count testing; Second microfluidic disc for immunoassay; A third microfluidic disc for clinical chemistry analysis; or Any combination thereof.

[0154] Item E8. The drawer according to Item E6 or E7, wherein the first drawer insert and the second drawer insert are formed as a single unit.

[0155] Item E9. The drawer according to any one of items E6-E8, wherein the first drawer insert further comprises: A base portion having a layer retaining member configured to engage with a retaining member of the outer shell of the corresponding package to restrict rotation of the outer shell of the corresponding package relative to the corresponding drawer layer.

[0156] Item E10. The drawer according to Item E9, wherein the first drawer compartment further comprises: An interlayer camera is positioned at the interlayer base and configured to retrieve information from a barcode on the outer shell of the corresponding package.

[0157] Item E11. The drawer according to any one of items E1-E10, further comprising: A drawer base configured for connection with a guide rail in the housing adjacent to a door, wherein the one or more drawer inserts are mounted on the drawer base; and Drawer rollers, which are connected to the drawer chassis and configured to open the door.

[0158] Item E12. The drawer as described in item E11, wherein: The door is connected to the housing by one or more spring hinges and can rotate relative to the housing about the door hinge axis; The drawer base can slide in a direction approximately perpendicular to the axis of the door hinge; The drawer rollers are connected to the drawer base, allowing them to move together with the drawer base and rotate about a roller rotation axis that is generally parallel to the door hinge axis. As the drawer base slides towards the door, the drawer rollers roll on the inner surface of the door, thus pushing the door open; and As the drawer base slides away from the door, one or more spring hinges pull and close the door.

[0159] Item F1. A system comprising: The clamp according to any one of items A1-A16; The retainer according to any one of entries B1-B11; The shaker according to any one of items C1-C14; Capping / removing device according to any one of items D1-D13; The drawer according to any one of items E1-E12; Pipetting equipment; Multiple analysis modules, each configured to receive a microfluidic disk and analyze biological samples; A detection unit is configured to perform one or more of the following: (i) Detect any microfluidic faults on the microfluidic disk in each of the multiple analysis modules; (ii) To detect the position of clamps, holders, shakers, capping / uncapping devices, drawers, or any combination thereof, thereby providing information for the automatic calibration of the system; and (iii) Perform one or more measurements; A thermal management unit is configured to maintain the system within a predetermined temperature range; or Any combination thereof.

[0160] Item F2. The system according to Item F1, wherein the plurality of analysis modules include: A first analysis module is configured to receive a first microfluidic disk and perform a complete blood cell count test; A second analysis module, configured to receive a second microfluidic disk and perform an immunoassay; and The third analysis module is configured to receive a third microfluidic disk and perform clinical chemistry analysis.

[0161] Item F3. The system according to Item F1 or F2, wherein the detection unit includes one or more image cameras.

[0162] Item F4. The system according to any one of items F1-F3, further comprising: The housing includes a door and a user interface; Chassis; and Gantry crane.

[0163] Item F5. The system according to any one of items F1-F4, further comprising: A control unit for operating a gripper, holder, shaker, capping / removing device, drawer, pipetting device, multiple analysis modules, detection unit, thermal management unit, or any combination thereof.

[0164] Item F6. A method for determining one or more analytes in a biological sample using a system according to any one of items F1-F5.

[0165] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the claims. As used in the description of embodiments and the appended claims, the singular forms “a,” “an,” and “the” are also intended to include the plural forms unless the context clearly indicates otherwise. It will be understood that the terms “left side” or “right side,” “top” or “bottom,” “lower” or “upper,” “inner” or “outer,” “inward” or “outward,” etc., are used to describe the location of features with reference to the exemplary embodiments shown in the figures. It will be understood that while various elements may be described herein using the terms “first,” “second,” etc., these elements should not be limited by these terms. These terms are used only to distinguish one element from another. For example, a first element may be referred to as a second element, and similarly, a second element may be referred to as a first element, provided that “first element” and “second element” are consistently renamed without altering the meaning of the description.

[0166] As used herein, the term “and / or” means and includes any and all possible combinations of one or more of the listed items. It will be further understood that the terms “comprising,” “containing,” “including,” “including,” “comprise,” and / or “including” as used in this specification specify the presence of the stated features, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0167] The term “about” or “approximately” is used herein to provide literal support for exact figures that follow and figures that are close to or approximate to the figures that follow the term. In determining whether a figure is close to or approximates a specifically stated figure, a close to or approximate unstated figure may be one that, in the context in which the figure appears, provides a substantial equivalent to the specifically stated figure. It should be understood that all numerical values ​​and ranges disclosed herein are approximate values ​​and approximate ranges, whether or not “about” is used in conjunction with them. It should also be understood that the term “about” as used herein in conjunction with a figure refers to a value that can be ±0.01% (inclusive), ±0.1% (inclusive), ±0.5% (inclusive), ±1% (inclusive); ±2% (inclusive); ±3% (inclusive); ±5% (inclusive); ±10% (inclusive); or ±15% (inclusive). It should be further understood that when a numerical range is disclosed herein, any numerical value falling within that range is also disclosed in particular.

[0168] Depending on the context, the term "if" as used herein may optionally be interpreted as "when," "at," or "in response to determination," "in response to detection," or "according to determination." Similarly, depending on the context, the phrase "if determination" or "if [the stated condition or event] is detected" may optionally be interpreted as "in response to determination," "when [the stated condition or event] is detected," "in response to detection," or "according to determination that [the stated condition or event] is detected."

[0169] When a reference numeral is given the designation "i", it refers to a general component, assembly, or embodiment. For example, "unit i" refers to the i-th unit among a plurality of units.

[0170] All references cited in this document are incorporated herein by full reference and, for all purposes, to the extent that each individual publication or patent or patent application is specifically and individually indicated to be incorporated herein by full reference for all purposes.

Claims

1. A system comprising: One or more analysis modules, each configured to receive a corresponding microfluidic disk and perform optical analysis on the corresponding biological sample.

2. The system according to claim 1, wherein the one or more analysis modules are composed of a single analysis module.

3. The system according to claim 1, wherein the one or more analysis modules include a plurality of analysis modules.

4. The system according to claim 3, wherein the analysis modules of the plurality of analysis modules are capable of performing optical analysis independently or simultaneously with each other.

5. The system according to claim 3, wherein the plurality of analysis modules are capable of performing a full set of tests.

6. The system according to claim 5, wherein the one or more analysis modules comprise: A first analysis module is configured to receive a first microfluidic disk and measure one or more hematological parameters; The second analysis module is configured to receive the second microfluidic disk and perform an immunoassay. A third analysis module, configured to receive a third microfluidic disk and perform clinical chemistry analysis; or Any combination thereof.

7. The system according to claim 6, further comprising: A gripper configured to transport a corresponding microfluidic disk to or from each of the one or more analysis modules; A holder configured to hold one or more sample tubes; A shaker configured to mix or homogenize one or more biological samples in one or more sample tubes; A capping / re-capping device configured to remove caps from and / or recap sample tubes in one or more sample tubes; A drawer configured to receive consumables; A pipetting device configured to pipette a corresponding biological sample to a corresponding microfluidic tray; A detection unit, configured to perform one or more of the following: (i) Detect any microfluidic faults on the microfluidic disk in each of the plurality of analysis modules; (ii) Detecting the position of the clamp, the retainer, the shaker, the capping / uncapping device, the drawer, or any combination thereof, thereby providing information for the automatic calibration of the system; as well as (iii) Perform one or more measurements; A thermal management unit, configured to maintain the system within a predetermined temperature range; or Any combination thereof.

8. The system of claim 7, wherein the detection unit comprises one or more image cameras.

9. The system according to claim 8, further comprising: A housing, the housing including a door and a user interface; Chassis; as well as Gantry crane.

10. The system of claim 9, further comprising: A control unit for operating the clamp, the retainer, the shaker, the capping / removing device, the drawer, the pipetting device, the plurality of analysis modules, the detection unit, the thermal management unit, or any combination thereof.

11. The system of claim 10, wherein the one or more analysis modules comprise at least three analysis modules powered by a single, uniform architecture and capable of being implemented in a modular and streamlined platform.

12. The system of claim 11, wherein the corresponding biological sample is equally divided into corresponding microfluidic disks for the optical analysis.

13. The system of claim 12, wherein the system is configured to accept a single consumable kit per sample.

14. The system of claim 13, wherein the one or more analysis modules are capable of providing multiple biomarker results.

15. The system of claim 14, wherein the one or more analysis modules are capable of providing 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 30, 40, 50, 60, 70, 80, 90, 100, or more than 100 biomarker results.

16. The system of claim 14, wherein the one or more analysis modules are capable of providing more than five biomarker results.

17. The system of claim 16, wherein optical analysis of the corresponding biological sample is performed using a single workflow with user-selectable reports.

18. The system of claim 17, wherein the system is automated.

19. The system of claim 18, wherein the system is configured to accept one or more sample tubes, homogenize one or more biological samples contained in the one or more sample tubes, and analyze the homogenized one or more biological samples without any user intervention.

20. The system of claim 19, wherein the system is configured to evaluate the quality of samples, reagents, and / or protocols.

21. The system of claim 19, wherein the system is configured to use telemetry information to transmit information about the quality of samples, reagents, and / or protocols.

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