Medical diagnostic analyzers for nursing points, and apparatus, systems and methods for performing medical diagnostic analysis on samples.

Abstract

An analyzer having an inner chassis surrounded by a housing includes: sample and diluent probes, a mixing housing including a first mixing chamber and a second mixing chamber, a flow cytometer including a flow unit, and sample and sheath pumps configured to perform a first set of tasks and a second set of tasks, respectively. The first set of tasks includes: aspirating a sample into the sample probe; dispensing a sample from the sample probe into the first and second mixing chambers; delivering a first sample diluent mixture to the flow unit; and delivering a second sample diluent mixture to the flow unit. The second set of tasks includes: dispensing a sheath into the flow unit in a manner cooperating with delivering the first sample diluent mixture to the flow unit; and dispensing a sheath into the flow unit in a manner cooperating with delivering the second sample diluent mixture to the flow unit.

Description

[0001] This application is a divisional application of application number 202180049518.2, with an entry date of January 10, 2023, entitled "Medical Diagnostic Analyzer for Nursing Points, and Apparatus, System and Method for Medical Diagnostic Analysis of Samples". Technical Field

[0002] This disclosure relates to medical diagnostics, and more specifically to medical diagnostic analyzers at points of care, and apparatus, systems and methods for performing medical diagnostic analysis on samples. Background Technology

[0003] Medical guidelines for many medical diagnostic systems, such as hematology analyzers, recommend analyzing samples as soon as possible after collection. However, this recommendation may be difficult to follow if the sample is obtained at the point of care but the testing is to be performed in an external or remote laboratory. Therefore, many physicians and veterinarians prefer to use point-of-care medical diagnostic analyzers to analyze fresh samples.

[0004] Point-of-care medical diagnostic analyzers (such as hematology analyzers) can use, for example, flow cytometry to determine the cellular contents of a blood sample. Blood cell measurements using flow cytometry typically require at least two separate measurements—one for red blood cells (RBCs) and platelets, and another for white blood cells (WBCs).

[0005] When preparing samples for delivery to a flow cytometer, a hematology analyzer can automatically generate a diluent for the whole blood sample in at least two steps, performed sequentially or in parallel. Whether performed serially or in parallel, at least two reaction chambers are used. One chamber can be used for RBCs, and the other for WBCs. In some analyzers, an additional chamber is used, for example, to perform hemoglobin concentration analysis. Each reaction chamber in such a hematology analyzer is typically contained within the instrument and must be rinsed between sample runs to prevent sample residue.

[0006] As can be understood, in order for a blood analyzer to perform the necessary tasks in the reaction chamber, deliver samples to the flow cytometer, and flush the fluid path between sample runs, multiple fluid transport components are required. These components include, for example: pumps for moving diluents and / or cleaning solutions around the system; pumps for removing fluid from the reaction chamber; valves for controlling the flow of fluid; metering devices for accurately dispensing samples and reagents into the reaction chamber; and tubing for connecting all fluid transport components. Therefore, a blood analyzer is a complex instrument with many cooperating systems and components. Summary of the Invention

[0007] To the extent consistent, any aspect and feature detailed herein may be used with or without any other aspect and feature detailed herein, whether such aspect and feature are described together or separately below. Furthermore, it should be understood that references to any particular numerical value herein include numerical ranges taking into account material and manufacturing tolerances generally accepted in the art and / or the error ranges of measuring instruments generally accepted in the art.

[0008] According to several aspects of this disclosure, an analyzer is provided comprising: an inner chassis; a housing surrounding the inner chassis; a sample probe operably coupled to the inner chassis within the housing and movable relative to the inner chassis; a diluent probe operably coupled to the inner chassis within the housing and movable relative to the inner chassis; a mixing housing supported on the inner chassis within the housing and defining a first mixing chamber and a second mixing chamber, each configured to receive a diluent stream; and a flow cytometer supported on the inner chassis within the housing and including a flow unit, a sample pump, and a sheath pump. The sample pump is disposed within the housing and configured to perform a first set of tasks, the first set of tasks including: aspirating a sample into the sample probe; dispensing a sample from the sample probe into the first mixing chamber; dispensing a sample from the sample probe into the second mixing chamber; delivering a first sample diluent stream mixture to the flow unit; and delivering a second sample diluent stream mixture to the flow unit. The sheath pump is disposed within the housing and configured to perform a second set of tasks, the second set of tasks including: dispensing the sheath into the flow unit in a manner cooperating with delivering the first sample dilution mixture to the flow unit; and dispensing the sheath into the flow unit in a manner cooperating with delivering the second sample dilution mixture to the flow unit.

[0009] In one aspect of this disclosure, the analyzer further includes a carrier that supports the sample probe and the diluent probe in a fixed orientation relative to each other. The carrier is operably coupled to and movable relative to the inner chassis within the housing to operably position the sample probe and the diluent probe, thereby enabling at least some of the first set of tasks and the second set of tasks.

[0010] In another aspect of this disclosure, a robotic assembly is provided, configured to manipulate the carrier relative to the inner chassis in the y and z directions to position the sample probe and the diluent probe to perform at least some of the first set of tasks and the second set of tasks. In several aspects, the robotic assembly may include y-axis and z-axis potentiometers configured to provide feedback-based control over the movement of the carrier in each of the y and z directions.

[0011] In another aspect of this disclosure, the analyzer further includes a first diluent pump and a second diluent pump, which are disposed within the housing and configured to deliver the diluent stream to the first mixing chamber and the second mixing chamber, respectively.

[0012] In another aspect of this disclosure, the analyzer further includes a peristaltic pump configured to perform a third set of tasks, the third set of tasks including: aspirating a first sample dilution stream from the first mixing chamber into the dilution probe; aspirating a second sample dilution stream from the second mixing chamber into the dilution probe; aspirating a mixture of the first sample dilution streams through the dilution probe in preparation for delivery to the flow unit; aspirating a mixture of the second sample dilution streams through the dilution probe in preparation for delivery to the flow unit; aspirating residual fluid in the first mixing chamber for disposal; and aspirating residual fluid in the second mixing chamber for disposal.

[0013] In another aspect of this disclosure, the second set of tasks further includes: dispensing a sheath into the first mixing chamber to clean the first mixing chamber; and dispensing a sheath into the second mixing chamber to clean the second mixing chamber.

[0014] In another aspect of this disclosure, the mixing housing further defines a cleaning chamber, and wherein the second set of tasks further includes dispensing a sheath into the cleaning chamber to clean a portion of the sample probe disposed therein. The mixing housing additionally or alternatively defines a cavity configured to receive the other of the sample probe or the diluent probe when one of the sample probe or the diluent probe is inserted into one of the first mixing chamber or the second mixing chamber.

[0015] In another aspect of this disclosure, the analyzer also includes a hemoglobin assembly disposed in parallel with the flow unit.

[0016] In another aspect of this disclosure, the analyzer includes a door that provides selective access through the housing to the inner chassis, thereby selectively inserting and removing at least one package comprising reagent fluid and sheath flow.

[0017] In another aspect of this disclosure, the analyzer includes a drawer that provides selective access through the housing to the inner chassis for selectively inserting and removing sample tubes containing samples.

[0018] In another aspect of this disclosure, the analyzer further includes a fluid capacitor-filter-resistor circuit disposed within the sheath flow line, such that the sheath distributed to the flow unit passes through the fluid capacitor-filter-resistor circuit.

[0019] Another analyzer provided according to various aspects of this disclosure includes: an inner chassis, a housing surrounding the inner chassis, a drawer, a decapsulator assembly, and a robotic assembly. The drawer includes a sample tube container configured to hold sample tubes therein. The drawer is disposed within the housing and is at least partially removable from the housing. The decapsulator assembly is disposed within the housing and includes a decapsulator body defining a cam surface and having a sample tube holder. The decapsulator body is pivotally coupled to the inner chassis and is pivotable relative to the inner chassis between a retracted position and an operational position. The robotic assembly is mounted on the inner chassis and includes: a fixed frame; a y-axis body operably coupled to the fixed frame and movable relative to the fixed frame in the y-direction; and a carrier operably coupled to the y-axis body. The y-axis body includes a leg extending therefrom, the leg defining a foot at its free end. The carrier is movable in the y-direction together with the y-axis body and is movable in the z-direction relative to the y-axis body along its legs. Movement of the y-axis body in the y-direction toward vertical alignment with the sample tube held within the sample container causes the legs to contact the cam surface, thereby pivoting the decapsulator body from the retracted position to the use position, in which the sample tube holder clamps the sample tube and centers the sample tube relative to the sample tube holder.

[0020] In one aspect of this disclosure, the carrier supports a sample probe therein, and the carrier is configured to move the sample probe in the y-direction to vertical alignment with the sample tube, and in the z-direction into the sample tube to aspirate a sample therefrom. The carrier may also support the diluent probe in a fixed orientation relative to the sample probe.

[0021] In another aspect of this disclosure, the robot assembly further includes y-axis and z-axis potentiometers configured to perform feedback-based control of the movement of the carrier in each of the y and z directions.

[0022] In another aspect of this disclosure, the robot assembly further includes a y-axis guide screw motor assembly comprising: a motor, a guide screw operably coupled to the motor, and a nut threadedly engaged around the guide screw. The nut engages with the y-axis body such that actuation of the motor rotates the guide screw, causing the nut and the y-axis body to translate in the y-direction. Additionally or alternatively, the robot assembly further includes a z-axis guide screw motor assembly comprising: a motor, a guide screw operably coupled to the motor, and a nut threadedly engaged around the guide screw. The nut engages with the carrier such that actuation of the motor rotates the guide screw, causing the carrier to translate in the z-direction.

[0023] In another aspect of this disclosure, the analyzer further includes a camera configured to identify the type of sample tube held within the sample tube container. The robotic component is configured to control at least one of y-direction movement or z-direction movement based on the identified sample tube type.

[0024] According to this disclosure, a filter holder and ejector system for use with an analyzer or other suitable device is provided, the filter holder and ejector system including a base, a bottom cup-shaped portion, a top cap, and a handle. The base defines a top portion, a bottom portion, a front side, and a rear side, and is configured to receive a filter having a filter body, an inlet fitting, and an outlet fitting. The bottom cup-shaped portion is disposed at the bottom portion of the base, defines an outlet, and includes a first gasket disposed therein. The bottom cup-shaped portion is configured to receive at least a portion of the outlet fitting of the filter. The top cap is movably supported toward the top portion of the base, defines an inlet, and includes a second gasket disposed therein. The handle is pivotally coupled to the base and operatively coupled to the top cap. The handle is pivotally coupled to the base and operably coupled to the top cap, wherein the handle is pivotable relative to the base from a neutral position to an engaged position to push the top cap around at least a portion of the inlet fitting of the filter, such that the first gasket seals the interface between the outlet fitting of the filter and the outlet of the bottom cup-shaped portion, and the second gasket seals the interface between the inlet fitting of the filter and the inlet of the top cap.

[0025] In one aspect of this disclosure, the filter holder and ejector system further includes a clip disposed between a top and bottom portion of the base and extending from the front side of the base. The clip is configured to engage the body of the filter therein. In these aspects, a rear support pivotally coupled about a pivot to the rear side of the base may be provided. The rear support includes at least one leg positioned such that pivoting of the rear support about the pivot relative to the base causes the at least one leg to extend through a window defined by the base. The at least one leg is configured to contact the body of the filter and disengage the filter body from the clip as it extends through the window.

[0026] In another aspect of this disclosure, the rear support also includes at least one cam cam angle disposed on the opposite side of the pivot compared to the at least one leg, such that the at least one leg extends through the window in response to a push from the at least one cam cam angle in the opposite direction.

[0027] In another aspect of this disclosure, the handle is operably positioned relative to the at least one cam lobe and is also pivotable from the neutral position to the ejected position. Movement of the handle from the neutral position to the ejected position pushes the at least one cam lobe in the opposite direction, thereby pivoting the rear support so that the at least one leg extends through the window.

[0028] In another aspect of this disclosure, the handle is connected to the top cap via at least one linkage mechanism.

[0029] According to an aspect of this disclosure, a hemoglobin detection unit is also provided for determining the concentration of hemoglobin in a blood sample, for example, within an analyzer, a discrete device, or a separate device. The hemoglobin detection unit includes a first component and a second component, each including a body, a cutout, a block, and a fitting. The body defines an upper surface and has a first end portion and a second end portion. A channel extends along the upper surface. The cutout is defined within the body at the first end portion of the body, while the block is complementary to the cutout and disposed on the upper surface of the body at the second end portion of the body. The block defines a channel that cooperates with a portion of the channel of the body to define a closed lumen segment. The fitting extends from an end face of the body at the second end portion of the body and defines an internal passage communicating with the closed lumen segment. The second component is inverted, oriented in the opposite direction, and disposed on the first component such that the upper surfaces are abutting each other, such that the cutout receives the block to define a generally rectangular body, and such that a continuous lumen extends between the internal passages of the fitting.

[0030] In one aspect of this disclosure, the first component and the second component are fixed to each other, for example, by laser welding.

[0031] In another aspect of this disclosure, the first and second components are formed of plastic (e.g., acrylic resin).

[0032] In another aspect of this disclosure, the cut and the block define complementary angled surfaces.

[0033] This disclosure discloses a debris collector for an analyzer, the debris collector including a first disc body, a second disc body, and a filter screen. The first disc body includes an inlet fitting defining a first cavity and includes a first annular surface surrounding the first cavity. The first cavity defines a base plate that is at least partially angled such that the depth of the first cavity decreases diametrically from a first position adjacent to the inlet fitting to a second position spaced apart from the inlet fitting. The second disc body engages with the first disc body to define a disc housing, the second disc body including an outlet inlet fitting defining a second cavity and including a second annular surface surrounding the second cavity. The filter screen is disposed between the first disc body and the second disc body, separating the first cavity from the second cavity.

[0034] In one aspect of this disclosure, the first disc body and the second disc body are configured to engage with each other, wherein the annular periphery of the filter screen is respectively held between the first annular surface of the first disc body and the second annular surface of the second disc body.

[0035] In another aspect of this disclosure, the first disc body and the second disc body are fixed together by ultrasonic welding.

[0036] In another aspect of this disclosure, the inlet fitting and the outlet fitting are located at positions substantially radially opposite to the disc housing.

[0037] In another aspect of this disclosure, the second cavity is defined as having a substantially uniform depth in the diametrical direction from a third position adjacent to the outlet fitting to a fourth position spaced apart from the outlet fitting.

[0038] According to this disclosure, a connector is provided for connecting a pipe to a fitting, such as an analyzer. The connector includes a body having a first open end, a second open end, and an inner cavity extending between the first and second open ends. The diameter of the inner cavity tapers inward from the first open end of the body to a first internal location within the body, and tapers inward from the second open end of the body to a second internal location within the body. The tapering portion of the inner cavity is configured to facilitate press-fitting of a pipe or fitting into the inner cavity through each of the first and second open ends of the body.

[0039] In one aspect of this disclosure, the body further includes a first flared end portion surrounding the inner cavity at the first open end, the first flared end portion being configured to facilitate insertion of the pipe or the fitting into and centering it within the inner cavity. Additionally or alternatively, the body also includes a second flared end portion surrounding the inner cavity at the second open end, the second flared end portion being configured to facilitate insertion of the pipe or the fitting into and centering it within the inner cavity.

[0040] In another aspect of this disclosure, the body defines an elbow, and wherein the cavity is substantially conformable to the elbow. Optionally, the body extends substantially in a straight line.

[0041] Another analyzer provided according to this disclosure includes: an inner chassis; a housing surrounding the inner chassis; a sample tube container capable of being positioned within the housing and configured to hold sample tubes therein; and a robotic assembly mounted on the inner chassis. The robotic assembly includes: a fixed frame; a y-axis body operably coupled to the fixed frame and movable relative to the fixed frame in the y-direction; and a carrier operably coupled to the y-axis body. The carrier is movable together with the y-axis body in the y-direction, and the carrier supports sample probes and diluent probes thereon in a fixed position and orientation relative to each other.

[0042] In one aspect of this disclosure, the y-axis body includes a leg extending therefrom, and the carrier is movable relative to the y-axis body along its leg in the z-direction.

[0043] In another aspect of this disclosure, the carrier is configured to move in the y-direction to vertically align the sample probe with the sample tube, and to move the sample probe into the sample tube in the z-direction to aspirate a sample therefrom.

[0044] In another aspect of this disclosure, the analyzer includes a plurality of mixing chambers disposed within the housing and mounted on the inner chassis. In a first operation, the carrier is configured to move in the y-direction to vertically align the sample probe with one of the mixing chambers, and to move the sample probe in the z-direction into one of the mixing chambers. In a second operation, the carrier is configured to move in the y-direction to vertically align the diluent probe with one of the mixing chambers, and to move in the z-direction to enter said one of the mixing chambers.

[0045] In another aspect of this disclosure, the robot assembly further includes at least one of a y-axis potentiometer or a z-axis potentiometer, the at least one of which is configured to perform feedback-based control on the movement of the carrier in the y-direction or the z-direction, respectively.

[0046] In another aspect of this disclosure, the analyzer further includes at least one of a y-axis guide screw motor assembly configured to move the carrier in the y-direction, or a z-axis guide screw motor assembly configured to move the carrier in the z-direction. Attached Figure Description

[0047] The various aspects and features of this disclosure are described below with reference to the accompanying drawings, in which:

[0048] Figure 1 This is a front perspective view of a blood analyzer provided in accordance with the contents of this disclosure;

[0049] Figure 2 yes Figure 1 Rear view of the blood analyzer;

[0050] Figure 3 yes Figure 1 A front perspective view of the blood analyzer, with the outer casing removed;

[0051] Figure 4 yes Figure 1 A rear-view perspective view of a blood analyzer, with the outer casing removed;

[0052] Figure 5 yes Figure 1 A side perspective view of the blood analyzer, with the outer casing, sheath fluid, and waste package removed.

[0053] Figure 6 yes Figure 1 A schematic diagram of the fluid system of a blood analyzer;

[0054] Figure 7 yes Figure 1 First side perspective view of the syringe pump, peristaltic pump, mixing assembly and associated tubing of a blood analyzer;

[0055] Figure 8 yes Figure 1 A second-side perspective view of the syringe pump, peristaltic pump, mixing assembly, and associated tubing of a blood analyzer;

[0056] Figure 9 yes Figure 7 An enlarged perspective view of multiple parts of a syringe pump, illustrating the connector that connects the associated tubing to the syringe pump;

[0057] Figure 10 It is a perspective view of the pipe, including different types of connectors attached to its opposite ends;

[0058] Figure 11 It is a perspective view of the pipe, including similar connectors attached to its opposite end;

[0059] Figure 12 It spans Figure 10 The cross-sectional view taken from the cross-section line "12-12";

[0060] Figure 13A yes Figure 1 Top-view perspective view of the robotic components of a blood analyzer;

[0061] Figure 13B yes Figure 13A A bottom-view perspective view of the robot components;

[0062] Figure 14A yes Figure 1 A perspective view of a portion of a blood analyzer, showing the outer casing removed, revealing... Figure 13A The robot component is shown in the first position, where the decapsulator body of the blood analyzer is positioned at the storage location.

[0063] Figure 14B yes Figure 1 A perspective view of a portion of a blood analyzer, in which Figure 13A The robot component is in the second position, and the decapsulator body of the blood analyzer is in the use position;

[0064] Figure 15 yes Figure 13A Exploded perspective view of robot components;

[0065] Figure 16 and Figure 17 They are Figure 1 Front and side perspective views of one of the syringe pumps in a blood analyzer;

[0066] Figure 18 yes Figure 16 and Figure 17 Exploded perspective view of a syringe pump;

[0067] Figure 19 and Figure 20 yes Figure 1 Enlarged perspective views of a portion of a blood analyzer, showing the external and internal views respectively, illustrating the analyzer's debris collector;

[0068] Figure 21 and Figure 22 They are Figure 19 and 20Front and rear perspective views of the debris collector;

[0069] Figure 23 yes Figure 19 and Figure 20 Exploded perspective view of a debris trap;

[0070] Figure 24 It spans Figure 22 The cross-sectional view taken from the cross-section line "24-24";

[0071] Figure 25 yes Figure 1 An enlarged perspective view of a portion of a blood analyzer, showing the analyzer's hemoglobin detection unit;

[0072] Figure 26 yes Figure 25 Exploded perspective view of the hemoglobin detection unit;

[0073] Figure 27 yes Figure 25 A perspective view of the hemoglobin detection unit;

[0074] Figure 28A yes Figure 1 A perspective view of the filter holder and ejector assembly of a blood analyzer;

[0075] Figure 28B yes Figure 28A Exploded perspective view of the filter retainer and ejector assembly;

[0076] Figures 29A to 29D The diagram shows the filter in Figure 28A A progressive perspective view of the insertion and engagement within the filter retainer and ejector components;

[0077] Figure 30 and Figure 31 They are Figure 1 Front and rear perspective views of the hybrid components of the blood analyzer; and

[0078] Figure 32 yes Figures 30 to 31 An exploded perspective view of the mixed components. Detailed Implementation

[0079] This disclosure relates to a point-of-care or point-of-care medical diagnostic analyzer, and apparatus, systems, and methods for performing medical diagnostic analysis on samples. While aspects and features of this disclosure are described herein in detail with respect to blood analyzers including flow cytometers for hematological analysis of blood samples (e.g., for testing human or animal blood samples), these aspects and features are equally applicable to use with other suitable analyzer apparatuses, systems, and methods, and to the use of flow cytometers in place of or as an adjunct to other diagnostic tools.

[0080] Overall reference Figures 1 to 8 This illustration shows a blood analyzer incorporating a flow cytometer according to the present disclosure, generally identified by reference numeral 10. The analyzer 10 includes a housing 12 and an inner chassis 14, which cooperate to enclose and support the internal working components of the analyzer 10 therein. A door 20, hinged or otherwise operably coupled to the inner chassis 14, provides selective access to the interior of the housing 12 to allow insertion and removal of the sheath fluid and waste pack 30, reagent pack 40, and filter 50. Any suitable sheath fluid and waste pack 30 and reagent pack 40 can be used, such as those detailed, for example, in patent application publication number US 2019 / 0299213, entitled “POINT-OF-CARE DIAGNOSTIC SYSTEMS AND CONTAINERS FOR SAME,” filed March 30, 2018, the entire contents of which are incorporated herein by reference. A drawer 60, slidably or otherwise operably coupled to the inner chassis 14, includes a first container 62 and a second container 64, which can be selectively accessed or entered through the open drawer 60 to allow the sample tube 70 and the onboard control tube 80 to be inserted and removed from the respective containers 62, 64 (see [link to relevant documentation]). Figure 14B The first container 62 is configured as a universal container capable of holding various types of sample tubes (e.g., more than twenty different types of sample tubes), both capped and uncovered (see [link]). Figure 14B Multiple ports (such as, for example, power port 92, data port 94, and peripheral port 96) can be accessed or entered from the outside of the housing 12 to connect power lines, Ethernet cables, and peripheral cables to the analyzer 10, respectively.

[0081] The internal working components of the analyzer 10 include a robotic assembly 100, four (4) syringe pumps 210 to 240, a mixing assembly 300, a peristaltic pump 400, a debris collector 500, a hemoglobin assembly 600, a filter holder and ejector assembly 700, and a flow cytometer assembly 800. The analyzer 10 also includes various tubing, valves, and associated connectors that fluidly link the aforementioned internal working components to each other, a sheath fluid and waste pack 30, a reagent pack 40, a filter 50, and sample tubes 70 (…). Figure 14B ), and / or airborne control tube 80 ( Figure 14B This allows for the selective creation of various fluid paths, as detailed below. Furthermore, various sensors, other electrical hardware, electrical connections, and circuit boards are provided for the operation and control of the analyzer 10, as also detailed below.

[0082] Robotic assembly 100 defines a dual-probe configuration having a carrier 102 that engages a sample probe 110 and a diluent probe 120 in a fixed, oriented manner spaced apart from each other. Robotic assembly 100 is configured to manipulate sample probe 110 to aspirate a sample from sample tube 70 during initial sample operation, deposit a first portion of the sample into the WBC chamber 310 of mixing assembly 300, deposit a second portion of the sample into the RBC chamber 320 of mixing assembly 300, and immerse sample probe 110 in the cleaning chamber 330 of mixing assembly 300. During initial control operation, robotic assembly 100 is configured to manipulate sample probe 110 to aspirate a control sample from onboard control tube 80, deposit a first portion of the control sample into the WBC chamber 310 of mixing assembly 300, deposit a second portion of the control sample into the RBC chamber 320 of mixing assembly 300, and immerse sample probe 110 in the cleaning chamber 330 of mixing assembly 300. The robot assembly 100 is also configured to manipulate the diluent probe 120 to immerse the diluent probe 110 into the cleaning chamber 330 of the mixing assembly 300. The robot assembly 100 is described in more detail below.

[0083] Continue with overall reference Figures 1 to 8 And additional reference Figure 6 The four (4) syringe pumps include: a sample syringe pump 210, a WBC reagent syringe pump 220, an RBC reagent syringe pump 230, and a sheath syringe pump 240. The sample syringe pump 210 is operatively coupled to the sample probe 110 and, more specifically, is configured to provide suction through the sample probe 110 to draw fluid from the sample tube 70 ( Figure 14B ) samples (or from airborne control tube 80 ( Figure 14BThe controlled sample is aspirated into sample probe 110 to provide pressure, thereby propelling a first and a second portion of the sample into the WBC chamber 310 and RBC chamber 320 of the mixing assembly 300, respectively, and delivering the sample-reagent mixture to the flow unit 810 of the flow cytometer assembly 800. WBC reagent injector pump 220 and RBC reagent injector pump 230 are respectively connected between the reagent pack 40 of the mixing assembly 300 and the WBC chamber 310 and RBC chamber 320. More specifically, WBC reagent injector pump 220 and RBC reagent injector pump 230 are configured to provide suction to aspirate reagent from reagent pack 40 and to provide pressure to propel reagent into the WBC chamber 310 and RBC chamber 320 of the mixing assembly 300, respectively. Sheath injector pump 240 is operatively connected to the sheath flow and waste pack 30, sample probe 110, and flow unit 810 of the flow cytometer assembly 800. More specifically, the sheath syringe pump 240 is configured to provide suction to draw sheath flow from the sheath flow and waste pack 30, provide pressure to deliver the sheath flow to the flow unit 810 of the flow cytometer assembly 800, and provide pressure to deliver the sheath flow to the clean chamber 330 of the mixing assembly 300. Syringe pumps 210 to 240 are described in more detail below.

[0084] The mixing assembly 300 of the analyzer 10 includes a multi-chamber mixing housing 302, as mentioned above, defining a WBC chamber 310, an RBC chamber 320, and a cleaning chamber 330. The multi-chamber mixing housing 302 also defines a cavity 340 positioned relative to the WBC chamber 310, RBC chamber 320, and cleaning chamber 330, such that the sample probe 110 and the diluent probe 120 can be operatively connected to one or more of chambers 310, 320, and 330 without requiring other probes 110, 120 to be connected to the multi-chamber mixing housing 302. A WBC reagent syringe pump 220 and an RBC reagent syringe pump 230 are mounted as part of the mixing assembly 300, but other configurations are also considered. The mixing assembly 300 is described in more detail below.

[0085] A peristaltic pump 400 is operatively coupled to a mixing assembly 300, a sheath fluid and waste package 30, a flow unit 810 of a flow cytometry assembly 800, and a diluent probe 120. More specifically, the peristaltic pump 400 is configured to aspirate fluid from the system and deposit it into the sheath fluid and waste package 30. More specifically, and for example, the peristaltic pump 400 is configured to aspirate the WBC chamber 310, RBC chamber 320, and clean chamber 330 of the mixing assembly 300 to empty waste fluid into the sheath fluid and waste package 30, and to aspirate sample-reagent mixtures from the WBC chamber 310 and RBC chamber 320 via the diluent probe 120 to enable delivery to the flow unit 810 of the flow cytometry assembly 800 (via the sample syringe pump 210).

[0086] The debris collector 500 of the analyzer 10 is positioned in the fluid path between the clean chamber 330 of the mixing assembly 300 and the sheath flow and waste pack 30 to capture any debris flushed from the clean chamber 330 as waste liquid from the clean chamber 330 is pumped into the sheath flow and waste pack 30. The debris collector 500 does not require replacement during the lifespan of the analyzer 10 but is configured to capture debris for its designated lifespan. The debris collector 500 is described in more detail below.

[0087] Still referencing Figures 1 to 8 And additional reference Figure 25 The hemoglobin assembly 600 is installed as part of the flow cytometer assembly 800, can be installed as part of another assembly, or can be installed separately. The hemoglobin assembly 600 is arranged in parallel with the flow unit 810 of the flow cytometer assembly 800. The hemoglobin assembly 600 includes a hemoglobin detection unit 610, a light source (not shown), and a sensor (not shown). The hemoglobin detection unit 610 is operatively coupled to the WBC chamber 310 and peristaltic pump 400 of the mixing assembly 300, allowing the sample to be drawn from the WBC chamber 310 to the hemoglobin detection unit 610 via a diluent probe 120, and ultimately to the sheath fluid and waste bag 30. Pulling the sample (e.g., a clump of lysed whole blood) through the hemoglobin detection unit 610 releases hemoglobin from the red blood cells. The clump of lysed whole blood passes through the hemoglobin detection unit 610, where the light source and sensor are capable of absorption measurements at one or more individual wavelengths of light to determine the hemoglobin concentration in the sample. The hemoglobin component 600 is described in more detail below.

[0088] Refer again Figures 1 to 8 The filter holder and ejector assembly 700 releasably holds the filter 50 therein. With the filter 50 engaged within the filter holder and ejector assembly 700, the filter 50 is operatively coupled between the sheath syringe pump 240 and the flow unit 810 of the flow cytometer assembly 800. The filter 50, together with the fluid capacitor 732 and the fluid resistor 734, forms a fluid capacitor-filter-resistor circuit 730 through which the sheath flow passes. This circuit 730 controls the flow of the sheath flow, which surrounds the sample core flow as the sample core flow passes through the flow unit 810, thereby facilitating core flow establishment. The filter holder and ejector assembly 700 is described in more detail below.

[0089] As mentioned above, the flow cytometer assembly 800 includes a flow unit 810 configured to facilitate flow of sample core flow and surrounding sheath flow. The flow cytometer assembly 800 also includes a mounting platform 820 on which laser optics (not shown), the flow unit 810, and forward scattering sensor assemblies and side scattering sensor assemblies (not shown) are mounted; and an outer cover 830 disposed on the mounting platform 820 and enclosing therein the laser optics, flow unit 810, and forward scattering sensor assemblies and side scattering sensor assemblies. Any suitable flow cytometer assembly 800 can be used, such as those detailed in, for example, US 2019 / 0302391, entitled “FLOW CYTOMETER, LASER OPTICSASSEMBLY THEREOF, AND METHODS OF ASSEMBLING THE SAME,” filed March 28, 2019, the entire contents of which are incorporated herein by reference.

[0090] Special Reference Figure 6As noted above, various pipes, valves, and connectors that fluidly link the internal working components of the analyzer 10 to each other, sheath fluid and waste packs 30, reagent packs 40, filters 50, sample tubes 70, and / or onboard control tubes 80, are provided to selectively establish various fluid paths. More specifically, regarding the valves (which may be electrically controlled solenoid valves or other suitable valves) located in the various fluid lines: a sample vent valve 902 is located in the sample probe line between the sample probe 110 and the sample syringe pump 210; a sample flow unit valve 904 is located in the sample probe line between the sample syringe pump 210 and the sample vent valve 902; a dilution valve 906 is located in the dilution probe line between the dilution probe 120, the sample syringe pump 210, and the flow unit 810; a flow unit valve 908 is located at a branch in the sample line, the branch separating between the flow unit 810 and the hemoglobin assembly 600; and WBC mixing valves 910 and RBC mixing valves 912 are located at the WBC reagent syringe pump 220 and the RBC reagent syringe pump 220, respectively. The reagent syringe pump 230 has an output; WBC cleaning valve 914 and RBC cleaning valve 916 are respectively located at the outputs of WBC chamber 310 and RBC chamber 320, and are also located in the discharge line from clean chamber 330; hemoglobin cleaning valve 918 is connected in the hemoglobin discharge line; sample cleaning valve 920 is located in the fluid line connecting sample syringe pump 210 to clean chamber 330; flow unit cleaning valve 922 is located in the output line of sheath syringe pump 240, at a branch between the fluid line of flow unit 810 and clean chamber 330; sheath flow unit valve 924 is located at the output of sheath syringe pump 240; and sheath hemoglobin valve 926 is located between sheath syringe pump 240 and hemoglobin assembly 600. The various fluid lines of analyzer 10 share multiple stages and / or are operatively interconnected with one or more other fluid lines via branches, valves, etc. Furthermore, although each specific fluid line and / or portion thereof of the analyzer 10 is not explicitly described herein, it should be understood that, in cases where fluid flow from one component to another is described in detail, direct or indirect fluid lines or portions thereof extend between fluidly connected components.

[0091] Continue to refer to Figure 6Pressure sensors 932, 934, 936, 938, and 940 are associated with sample syringe pump 210, WBC reagent syringe pump 220, RBC reagent syringe pump 230, sheath syringe pump 240, and peristaltic pump 400, respectively, to provide feedback on the associated pressure. Pressure sensors 932 and 940 can be configured as flow-through pressure sensors, while pressure sensors 934, 936, and 938 can be configured as plate-mount pressure sensors, but other configurations are also possible. A fluid capacitor-filter-resistor circuit 730, formed by filter 50, fluid capacitor 732, and fluid resistor 734, is disposed in the sheath flow line between sheath syringe pump 240 and flow unit 810. Additional instantaneous references 3 to 5, the analyzer 10 includes various PCBAs, flexible circuits, electrical connectors, and / or other circuits, which mount and / or interconnect various electronic devices (hardware and / or implementation software) associated with the analyzer 10 to enable power supply, sensing, use, and / or control of various parts and components of the analyzer 10.

[0092] Turning Figures 9 to 12 Pipeline 950 (and / or other conduits, channels, etc.) connects to the various components of analyzer 10 detailed above to establish various fluid lines between the components. Pipeline 950 may be formed of PTFE or other suitable materials. For connecting pipeline 950 and fittings 960 associated with the various components of analyzer 10... Figure 7 The connection provides connectors 970 and 980. Connector 970 is configured as an elbow connector and can define an elbow angle of approximately 90 degrees or other suitable elbow angles. Connector 980 is configured as a linear connector, but other configurations are also possible. The different configurations of connectors 970 and 980 allow connection to fitting 960 in various orientations and / or with various entry clearances. Figure 7 ).

[0093] Each connector 970 defines a body 972, the body including a cavity 974 and a first open end 976 and a second open end 978 communicating with the cavity 974, respectively. The cavity 974 is defined in an angled or curved configuration to substantially conform to the elbow configuration of the connector 970 and the interconnecting open ends 976, 978. The diameter of the cavity 974 tapers inward from the first open end 976 and the second open end 978 of the body 972 through at least a plurality of portions of the cavity 974. The body 972 also includes flared end portions 977, 979, respectively disposed at their first open end 976 and the second open end 978 and surrounding the cavity 974. The flared end portions 977, 979 facilitate insertion into the end portion of the pipe 950 and the fitting 960, respectively. Figure 7And the end portion of pipe 950 and fitting 960 are centered therein. The first open end 976 and the second open end 978 of body 972 can be dedicated to receiving the end portion of pipe 950 and fitting 960, respectively. Figure 7 Conversely, or it could be generic so as to be able to accept either. The inner cavity 974 provides the end portion of the conduit 950 and fitting 960 respectively from the tapered configuration of the first opening end 976 and the second opening end 978 of the body 972. Figure 7 The increased pressure within them ensures a secure connection. Coupler 980 is configured similarly to coupler 970, except that coupler 980 defines a liner configuration instead of an elbow configuration. Couplers 970 and 980 advantageously achieve a quick, safe, and reliable connection by actuating the connecting components.

[0094] refer to Figures 13A to 15 As detailed above, the robot assembly 100 includes a carrier 102 that supports the sample probe 110 and the diluent probe 120 in a fixed position. The robot assembly 100 also includes a fixed frame 130, a y-axis body 140, a y-axis guide screw motor assembly 150, a z-axis guide screw motor assembly 160, a y-axis linear potentiometer 170, and a z-axis potentiometer 180. The fixed frame 130 is configured for secure mounting to the inner chassis 14 of the analyzer 10 and includes a pair of spaced-apart support rails 132 engaged therein and extending along the y-axis. The support rails 132 slidably support the y-axis body 140 thereon, such that the y-axis body 140 is restricted to movement in the y-direction relative to the fixed frame 130. The y-axis potentiometer 170 is fixed in the y-direction relative to at least a portion of the fixed frame 130 and extends thereal.

[0095] The y-axis guide screw motor assembly 150 includes a motor 152 mounted on a fixed frame 130, a guide screw 154 operably coupled to the motor 152 and extending therefrom along the y-axis, and a nut 156 threadedly engaged around the guide screw 154. The nut 156 is fixedly engaged with the y-axis body 140 such that when the motor 152 is actuated, the guide screw 154 is driven to rotate, thereby translating the nut 156. Therefore, the y-axis body 140 moves left or right relative to the fixed frame 130 along the y-direction (and along the support rail 132), depending on the actuation direction of the motor 152. The y-axis body 140 also includes a leg 142 hanging therefrom, the leg defining a foot 144 at its free end. A y-axis potentiometer 180 is fixed relative to and extends along the leg 142 in the z-direction.

[0096] The z-axis guide screw motor assembly 160 is supported on the y-axis body 140, and more specifically, includes a motor 162 mounted on the y-axis body 140, a guide screw 164 operably coupled to the motor 162 and extending therefrom in the z-direction, and a nut 166 threadedly engaged around the guide screw 164. The carrier 102 is fixedly engaged with the nut 166 such that when the motor 162 is activated, the guide screw 164 is driven to rotate, thereby translating the nut 166, and thus the carrier 102 (including the sample probe 110 and the diluent probe 120) moves upward or downward in the z-direction relative to the y-axis body 140, depending on the activation direction of the motor 162. The z-axis guide screw motor assembly 160 and the carrier 102 are coupled to the y-axis body 140 in a fixed position relative to the y-axis such that the z-axis guide screw motor assembly 160 and the carrier 102 translate in the y-direction in response to the translation of the y-axis body 140 along the y-axis. However, the carrier 102 is configured to translate in the z direction relative to the y-axis body 140, for example, in response to the start of the motor 162.

[0097] As a result of the detailed configuration described above, motors 152 and 162 enable the carrier 102 (including sample probe 110 and diluent probe 120) to move left or right in the y-direction and up or down in the z-direction to manipulate sample probe 110 and diluent probe 120 to their various operable positions, as detailed below. During the aforementioned movement, y-axis potentiometer 170 and z-axis potentiometer 180 encode the y-direction and z-direction positions, respectively, to provide feedback that determines the position of sample probe 110 and diluent probe 120, enabling accurate movement and positioning. Position- and / or impedance-based feedback can be used to precisely control the movement of probes 110 and 120 using potentiometers 170 and 180.

[0098] Special Reference Figure 14A and Figure 14B The chassis 14 of the analyzer 10 pivotally supports a desheller assembly 190 thereon. The desheller assembly 190 includes a desheller body 192, which is pivotally connected to the chassis 14 about a pivot 194, such that the desheller body 192 can be in a retracted position (…). Figure 14A ) and location of use ( Figure 14B Pivoting between ), in an embodiment, the sheller body 192 is biased toward the retracted position.

[0099] The sheller body 192 defines a sample tube holder 196, a control tube holder 198, and a cam surface 199. The sample tube holder 196 and the control tube holder 198 are configured to clamp onto the sample tube 70 and the control tube 80 respectively in the use position, with the sample tube and control tube centered therein. The cam surface 199 is positioned along its y-axis in the travel path of the foot 144 of the leg 142 of the y-axis body 140 of the robot assembly 100, such that as the y-axis body 140 moves in the y-direction toward the sample tube 70 to draw a sample from it, the foot 144 contacts the cam surface 199 and the cam along it, thereby pivoting the sheller body 192 from the retracted position to the use position.

[0100] The sample tube holder 196 is configured as a universal container capable of clamping and centering various types of sample tubes (e.g., more than twenty different types) with and without caps. Furthermore, cameras, barcode readers, and / or other suitable sensors can be incorporated into the robotic assembly 100 (or otherwise incorporated into the analyzer 10) to enable the detection of sample tubes from multiple (e.g., more than twenty different types and / or categories). Additionally or alternatively, measurements, hypotheses, etc., of unidentifiable sample tubes can be obtained via sensors. Based on the identified sample tubes or other acquired information, a database or other suitable data storage file storing setup information can be accessed to facilitate the use and control of the robotic assembly 100, for example, based on one or more of factors such as whether a cap is used, the size (height and diameter) of the sample tube, the volume of the sample tube, the curvature of the bottom of the sample tube, etc. In cases where sample tubes are not easily identifiable, default setup information and / or reliance on feedback-based control or more can be utilized.

[0101] refer to Figures 16 to 18Syringe pumps 210 to 240 are substantially similar to each other, except as detailed below and regarding capacity. For example, sample syringe pump 210 may include a 250 μL syringe and manifold, while the other syringe pumps 220 to 240 may include a 5 mL syringe and manifold, but other configurations are also considered. Syringe pumps 210 to 240 are configured to aspirate and dispense fluid and provide position and pressure feedback for accurate control thereto. Each syringe pump 210 to 240 includes a solenoid valve 252, a manifold 254, a PCBA 256, a stepper motor 258, a guide screw 260, a travel nut 262, a syringe 264, a pump base 266, and a hook pin 268. The guide screw 260 is operably engaged with and extends from the stepper motor 258 and includes a travel nut 262 threaded thereon. The plunger of syringe 264 is mounted on and engaged with travel nut 262 via hook pin 268, while the body of syringe 264 is fixed relative to pump base 266. Pump base 266 is supported on stepper motor 258 and receives guide screw 260, travel nut 262, and syringe 264 therein. Therefore, activation of stepper motor 258 drives rotation of guide screw 260, causing travel nut 262 to translate through pump base 266, and consequently causing plunger of syringe 264 to slide through its body to dispense or draw fluid according to the direction of travel. Manifold 254 is supported on the end of pump base 266 opposite to stepper motor 258, and a solenoid valve 252 is supported thereon and configured to guide fluid dispensed from syringe 264 to solenoid valve 252 for dispensing from a desired port. PCBA 256 extends externally along pump base 266 and includes, in at least some of the syringe pumps 210 to 240, a pressure sensor 257a mounted thereon to provide feedback on pump pressure within syringe 264. A linear potentiometer 257b may be disposed along at least a portion of the length of PCBA 256 to enable determination of the position of travel nut 262 (based on a potentiometer 263 associated with travel nut 262), and thus the deployment state of syringe pumps 210 to 240. A fitting 960 associated with manifold 254 enables connection of conduit 950 to allow fluid to flow in and out of syringe pumps 210 to 240.

[0102] Figures 19 to 24 The debris collector 500 of the analyzer 10 is shown. As mentioned above, the debris collector 500 is positioned in the fluid path between the clean chamber 330 of the mixing assembly 300 and the sheath flow and waste pack 30 to capture any debris flushed from the clean chamber 330 as waste liquid from the clean chamber 330 is pumped into the sheath flow and waste pack 30. The debris collector 500 is configured to capture debris for its lifetime value, therefore replacement is not required.

[0103] The debris collector 500 includes a disc-shaped housing 510 formed by a first disc body 520 and a second disc body 530, which are secured to each other by ultrasonic welding (or other suitable joining) and hold a filter screen 540 therebetween, such as a 100 µm screen or other suitable filter. The first disc body 520 and the second disc body 530 each include fittings 522 and 532, which project outwards from the fittings in opposite directions and are substantially radially opposed to the disc-shaped housing 510. The first disc body 520 defines a cavity 524 having a maximum width dimension at the fitting 522 and a tapering width to a minimum width dimension in a substantially radial direction toward the fitting 532. The second disc body 530 defines a cavity 534 of substantially constant width, but other configurations are also considered. The first disc body 520 and the second disc body 530 are fixed to each other. The inner annular surface 526 of the first disc body 520 holds the annular periphery of the filter screen 540 against the opposite annular surface 536 of the second disc body 530, so that the filter screen 540 is held in a separated position but allows fluid communication between the cavities 524 and 534.

[0104] Accessories 522 and 532 define an inner cavity that communicates with corresponding cavities 524 and 534. Accessory 522 is configured as an inlet, while accessory 532 is configured as an outlet. More specifically, accessory 522 is configured to engage with a conduit in the cleaning chamber 330 to receive waste liquid therefrom, while accessory 532 is configured to engage with a conduit in the sheath flow and waste bag 30 to convey waste liquid from the debris collector 500 to it. Waste liquid enters cavity 524 of the debris collector 500 through accessory 522, and due to the configuration of cavity 524 detailed above, debris is captured within cavity 524 without clogging the filter screen 540, thus allowing fluid to pass through the filter screen 540 into cavity 534, and ultimately travel out of accessory 532 to reach the sheath flow and waste bag 30.

[0105] Turning Figures 25 to 27 The hemoglobin assembly 600 is arranged parallel to the flow unit 810 of the flow cytometer assembly 800. The hemoglobin assembly 600 includes a hemoglobin detection unit 610, which is received within a pouch 642 of a complementary shape to the support structure 644 associated with the mixing assembly 300. Also as detailed above, the hemoglobin assembly 600 includes a light source and a sensor configured to enable absorption measurements at one or more individual wavelengths of light to determine the hemoglobin concentration in the sample.

[0106] The hemoglobin detection unit 610 is formed from two (2) identical components 612, 614. Each component 612, 614 is formed from a light-transmitting material with high optical clarity (e.g., acrylic resin) and may be molded or otherwise formed. One component 612, 614 is inverted and oriented oppositely to the other component 612, 614, and then the components 612, 614 are fixed to each other, for example by laser welding, to form the hemoglobin detection unit 610. More specifically, each component 612, 614 defines a rectangular body 652 having a channel 654 defined within the upper surface 656 of the rectangular body 652 and extending along the length of the rectangular body 652. An angled cutout 658 is defined at a first end portion 659 of the rectangular body 652, and an angled block 660 is provided at a second end portion 661 of the rectangular body 652. An angled cut 658 is located on the upper surface 656 of the rectangular body 652 and extends to the free end of its first end portion 659, such that the height of the first end portion 659 of the rectangular body 652 gradually decreases from the upper surface 656 to the free end of the first end portion 659.

[0107] As mentioned above, an angled block 660 is disposed at the second end portion 661 of the rectangular body 652. More specifically, the angled block 660 is located on top of the second end portion 661 of the rectangular body 652 and defines a channel cooperating with a portion of the channel 654 to define a channel for an inner cavity 662 extending between the angled block 660 and the rectangular body 652. The angled block 660 defines an angled inner surface 664, which is complementary to an angled surface defined by an angled cutout 658. The angled block 660 defines a maximum height equal to the maximum height of the rectangular body 652. A fitting 666 is formed at and extends outward from an end face 667 defined by the angled block 660 and the rectangular body 652, and includes an inner cavity 668 configured to communicate with the inner cavity 662. The fitting 666 is centered relative to the end face 667.

[0108] As a result of the configuration detailed above, when one of the components 612, 614 is oriented opposite to the other component 612, 614 and placed thereon such that the upper surfaces 656 mate with each other, the angled cutout 658 receives the angled block 660, thereby forming a completely rectangular body 670 and forming a continuous inner cavity extending between the fittings 666.

[0109] refer to Figures 28A to 29D As mentioned above, the filter retainer and ejector assembly 700 releasably retains the filter 50 therein. The filter 50 includes a filter body 52, an inlet fitting 54 disposed at one end of the filter body 52, and an outlet fitting 56 disposed at the other end of the filter body 52.

[0110] The filter holder and ejector assembly 700 includes a base 702, a rear support 704, a bottom seat 706, a bottom cup 708, a clip 710, a cap 712, a pair of connecting rods 714, a pivot handle 716, and a pair of gaskets 718, 720. The base 702 is fixedly attached to the inner chassis 14 of the analyzer 10 and is configured to directly or indirectly operably support various other components of the filter holder and ejector assembly 700. The rear support 704 includes a pair of spaced-apart tracks 705a interconnected by a crossbar 705b, which pivotally connects the rear support 704 to the base 702 on the rear side of the base 702. A pair of cam lobes 705c extend from the guide rail 704 at one end portion of the rear support 705a (located on one side of the crossbar 705b), and a pair of legs 705d extend from the guide rail 704 at opposite second end portions of the rear support 705a (located on the opposite side of the crossbar 705b). As a result of this configuration, pushing the cam lobes 705c in a first direction causes the rear support 704 to pivot about the crossbar 705b, causing the legs 705d to be pushed in the opposite second opposite direction, and vice versa. More specifically, the legs 705d are selectively extended from a retracted position to an extended position via a window 703 defined within the base 702, in response to pushing the cam lobes 705c in the reward direction.

[0111] The base 706 is supported on and hangs from the bottom portion of the base 702. A bottom cup-shaped portion 708 defines an outlet, located within the base 706, and receives a first gasket 718 therein. The bottom cup-shaped portion 708 is configured to receive the outlet fitting 56 of the filter 50 therein, while the gasket 718 establishes a seal around the interface between the outlet of the bottom cup-shaped portion 708 and the outlet fitting 56 of the filter 50 in the engaged state of the filter retainer and ejector assembly 700.

[0112] The clip 710 is supported on the base 702 at approximately the center position and extends forward from the base. The clip 710 is configured to receive the filter body 52 of the filter 50 therein in a snap-fit ​​engagement manner, thereby releasably engaging the filter 50 within the filter holder and ejector assembly 700.

[0113] The cap 712 is slidably attached to the top portion of the base 702. The cap 712 defines an inlet and holds a second gasket 720 therein. The cap 712 is configured to receive the inlet fitting 54 of the filter 50 therein, while the second gasket 720 establishes a seal near the interface between the inlet of the cap 712 and the inlet fitting 54 of the filter 50 when the filter holder and ejector assembly 700 are engaged. The cap 712 is movable between a disengaged position and an engaged position.

[0114] Link 714 is pivotally connected at its first end portion to a boss 713 of cap 712 and at its second end portion to a first boss 717a of pivot handle 716. Pivot handle 716 also includes a second boss 717b that pivotally connects pivot handle 716 to base 702 along a common pivot axis when link 714 and pivot handle 716 pivot. Pivot handle 716 additionally includes a lever 717c configured to facilitate pivoting of pivot handle 716 between an ejected position, a neutral position, and an engaged position.

[0115] During use, refer to Figures 29A to 29D And initially referenced Figure 29A and 29B In preparation for receiving the filter 50 in the filter holder and ejector assembly 700, the lever 717c of the pivot handle 716 is moved to the neutral position, wherein the cap 712 is in the disengaged position, and wherein the support leg 705d is in the retracted position. Once this is achieved, and additionally refer to Figure 29C The filter 50 can be inserted into the filter retainer and ejector assembly 700 such that the outlet fitting 56 of the filter 50 is at least partially received in the bottom cup-shaped portion 708, and the clip 710 is at least partially engaged around the filter body 52 of the filter 50.

[0116] Next, also refer to Figure 29D The lever 717c of the pivot handle 716 pivots downward from the neutral position to the engaged position to slide the cap 712 downward into the engaged position, wherein the filter 50 is held compressed between the gaskets 718, 720 of the bottom cup portion 708 and the cap 712, such that the filter 50 remains in a sealed engagement within the filter retainer and ejector assembly 700. Inlet and outlet conduits (not explicitly shown) are connected to the bottom cup portion 708 and the cap 712 to allow fluid flow (e.g., sheath flow) to pass through the filter 50 and the filter retainer and ejector assembly 700 without leakage.

[0117] Refer again Figures 29A to 29DTo disengage and remove the filter 50, the pivot handle 716 pivots from the engaged position through the neutral position to the ejected position. This pivoting of the pivot handle 716 from the engaged position to the neutral position displaces the cap 712, so that the filter 50 is no longer individually compressed between the gaskets 718 and 720 of the bottom cup-shaped portion 708 and the cap 712. The pivoting of the pivot handle 716 through the neutral position to the ejected position pushes the cam surface 717d of the pivot handle 716 into contact with the cam convex angle 705c of the rear bracket 704, thereby pivoting the rear bracket 704. This pushes the leg 705d through the window 703 defined within the base 702 and into contact with the filter body 52 of the filter 50, causing the filter body 52 to disengage from the clamp 710. Therefore, the filter 50 can be easily removed.

[0118] Back Figure 6 As mentioned above, the filter 50, in connection with the fluid capacitor 732 and the fluid resistor 734, forms a fluid capacitor-filter-resistor circuit 730 through which the sheath flow passes. This circuit 730 controls the flow of the sheath flow, which surrounds the sample core flow as it passes through the flow unit 810, thereby promoting the establishment of the core flow through the flow unit 810.

[0119] refer to Figures 30 to 32 The mixing assembly 300 includes a multi-chamber mixing housing 302, which is fixedly attached to the inner chassis 14 of the analyzer 10. The mixing assembly 300 also includes a bracket 304 that engages with the multi-chamber mixing housing 302 for mounting a valve thereon. Also as mentioned above, the multi-chamber mixing housing 302 includes a WBC chamber 310, an RBC chamber 320, a cleaning chamber 330, and a void cavity 340 to allow the sample probe 110 and the diluent probe 120 ( Figure 13A and Figure 13B ) can be operatively connected to one or more chambers 310, 320, 330 as detailed herein to form WBC dilution streams, RBC dilution streams, and to promote probes 110, 120 ( Figure 13A and Figure 13B The use of the mixing unit 300 is described in detail below in conjunction with the operating sequence described below, including the cleaning, filling, and flushing of chambers 310, 320, and 330.

[0120] See general overview Figure 6 and combined Figure 1 , Figures 3 to 5 , Figure 7 , Figure 8 , Figure 14A , Figure 14B and Figure 30This describes the sequence of operations for analyzing a sample using analyzer 10. The following sequence of operations details the order in which various functions are performed during sample operation. To avoid obscuring the sequence of operations with unnecessary detail, descriptions of some or all of the actions and / or some intermediate steps or processes that perform various functions (such as activating valves, reading sensors, providing feedback, refilling syringes, etc.) are omitted. Furthermore, unless specifically contradicted below, the steps may be performed in different orders, simultaneously, or with overlapping time relationships.

[0121] During sample preparation, if not present, the sheath fluid and waste pack 30, reagent pack 40, and filter 50 are manually loaded into the analyzer 10. The user interface of the analyzer 10, or the user interface associated with the analyzer 10, prompts the user to repeatedly and manually invert the sample tube 70, for example, 10 times, to homogenize the sample before running the sample on the analyzer 10. Once this is complete, the user manually opens drawer 60, inserts the sample tube 70 into container 62 of drawer 60, manually closes drawer 60, and presses start button 98 to initiate sample run.

[0122] Sample operation is typically divided into four stages: sample aspiration, diluent formation, diluent treatment, and cleanup. Initially, before starting the four stages mentioned above, all fluid lines except the waste line from the mixing assembly 300 are filled with sheath flow, and all syringe pumps 210 to 240 are set to the aspiration position.

[0123] Regarding sample aspiration, if sample tube 70 is stopped or capped, venting of sample tube 70 is performed first. To vent sample tube 70, robot assembly 100 translates carrier 102 from its in-situ, moving sample probe 110 in the y-direction to a position aligned with sample tube 70 along the y-axis. As detailed above, when robot assembly 100 translates carrier 102 in this manner, the legs 144 of robot assembly 100's y-axis body 140 contact and cause decapsulator body 192 to pivot from the retracted position to the use position, where sample tube holder 194 of decapsulator body 192 clamps onto and centers on the stop or cap of sample tube 70. Next, sheath injector pump 240 draws air through sample probe 110 until air passes through sample vent valve 902. Then, the robot assembly 100 translates the carrier 102 to move the sample probe 110 toward the sample tube 70 in the z-direction, such that the sharp tip of the sample probe 110 pierces the septum of the stopper or cap of the sample tube 70 and extends into the sample tube 70. After piercing the stopper or cap but before the sharp tip of the sample probe 110 reaches the liquid level (e.g., the surface of a blood sample) within the sample tube 70, the robot assembly 100 stops the z-direction movement of the sample probe 110. These and / or other movements relative to the sample tube 70 are achieved through impedance-based feedback, identification of the sample tube 70, and / or any other suitable means.

[0124] Continue venting of sample tube 70. Once sample probe 110 is positioned as mentioned above, for example, slightly below the stopper or cap but before the liquid level in sample tube 70, sample vent valve 902 is activated to connect the interior of sample probe 110 to the atmosphere, resulting in venting and pressure balance of sample tube 70.

[0125] After the sample tube 70 is vented, the robotic assembly 100 moves the carrier 102 to return the sample probe 110 away from the sample tube 70 in the z-direction (e.g., opposite to the z-direction movement detailed above). Due to the possibility of frictional engagement between the sample probe 110 and the punctured septum of the plug or cap of the sample tube 70, the sample tube holder 194 of the decapsulator body 190 holds the sample tube 70 in place, thereby inhibiting the sample tube 70 from moving together with the sample probe 110 in the z-direction.

[0126] If sample tube 70 is stopped or capped, and thus vented as detailed above, the sample line is refilled after the robot assembly 100 has fully retracted the sample probe 110 from sample tube 70 in the z-direction. For refilling, the robot assembly 100 translates the carrier 102 so that the sample probe 110 moves in the y-direction to be y-aligned with the cleaning chamber 330 of the mixing assembly 300, and then moves in the z-direction to the bottom of the cleaning chamber 330. As the carrier 102 moves away from sample tube 70 in the y-direction, the pusher body 192 pivots from the use position back to the retracted position under bias.

[0127] With the sample probe 110 positioned at the bottom of the cleaning chamber 330, the sheath injector pump 240 is activated to distribute sheath flow through the sample probe 110 (some of which exits the sample probe 110 and enters the cleaning chamber 330), thus re-infusing the sample tubing. The robotic assembly 100 then moves the carrier 102 to return the sample probe 110 in the z-direction to withdraw it from the cleaning chamber 330.

[0128] Once venting and refilling are complete (if necessary), sample aspiration can be initiated by the robotic assembly 100, which translates the carrier 102 to move the sample probe 110 in the y-direction to a position aligned with the sample tube 70 along the y-axis. This movement causes the legs 144 of the y-axis body 140 of the robotic assembly 100 to re-engage, and consequently causes the sheller body 192 to pivot from the retracted position to the use position to clamp onto the sample tube 70 and center the sample tube therein.

[0129] Then, the robot assembly 100 translates the carrier 102 to move the sample probe 110 in the z-direction into the sample tube 70 to its bottom or sufficiently below the sample surface to aspirate a suitable sample volume. The sample injector pump 210 is then activated to aspirate a predetermined volume of sample from the sample tube 70 into the sample probe line through the sample probe 110. The robot assembly 100 then moves the carrier 102 to retract the sample probe 110 from the sample tube 70 (by moving the sample probe in the z-direction).

[0130] In parallel with the sample aspiration detailed above, or at any other suitable point during the running sequence, a dark readout from the hemoglobin assembly 600 may be performed, for example, with the light source off, followed by a readout from the sheath of the hemoglobin assembly 600 with the light source on.

[0131] Continue with overall reference Figure 6 Combination Figure 6 and combined Figure 1 , Figures 3 to 5 , Figure 7 , Figure 8 , Figure 14A , Figure 14B and Figure 30 The diluent formation (the next stage of the run sequence) involves cleaning the sample probe 110, RBC diluent formation, and WBC diluent formation. Cleaning of the sample probe 110 is accomplished by the robotic assembly 110 first translating the carrier 102 to move the sample probe 110 to y-axis alignment with the cleaning chamber 330, and then moving it in the z-direction to advance the sample probe 110 to the bottom of the cleaning chamber 330. With the sample probe 110 positioned at the bottom of the cleaning chamber 330, the sheath injector pump 240 is activated to pump sheath flow into the cleaning chamber 330 until a sufficient volume exceeds the outlet of the sample probe 110 at its sharp tip. In some embodiments, the cleaning chamber 330 is substantially filled. Next, a peristaltic pump 400 is activated to aspirate the sheath flow from the cleaning chamber 330, thereby emptying the cleaning chamber 330 into the sheath flow and waste bag 30. This serves to flush the outer surface of at least one tip portion of the sample probe 110 (e.g., thereby removing debris accumulated due to punctures of the plug or cap). In some embodiments, the above rinsing may be repeated once or more.

[0132] After rinsing the sample probe 110 in the cleaning chamber 330, the robotic assembly 100 moves the carrier 102 to retract the sample probe 110 in the z-direction and exit the cleaning chamber 330. Next or subsequently, the peristaltic pump 400 draws fluid from the cleaning chamber 330 into the sheath flow and waste package 30.

[0133] Robotic assembly 100 translates carrier 102 to move sample probe 110 in the y-direction to y-axis alignment with RBC chamber 320 of mixing assembly 300. RBC reagent syringe pump 230 initially pumps a predetermined volume of RBC reagent into RBC chamber 320, and robotic assembly 100 translates carrier 102 to move sample probe 110 in the z-direction to the bottom of RBC chamber 320 (or otherwise below the reagent level). Next, in parallel (substantially, overlapping, etc.), sample syringe pump 210 is activated to pump a predetermined volume of sample through sample probe 110 and into RBC chamber 320, and RBC reagent syringe pump 230 pumps multiple pulses of a predetermined volume of RBC reagent from reagent pack 40 into RBC chamber 320. The diameter and offset of the reagent inlet port into RBC chamber 320 create an increased fluid velocity of the incoming RBC reagent, causing the RBC reagent and sample to vortex for uniform mixing of the diluent.

[0134] After the sample and RBC reagents are dispensed into the RBC chamber 320 (although some dispensing may still occur), the robotic assembly 100 translates the carrier 102 to withdraw the sample probe 110 from the RBC chamber 320.

[0135] WBC diluent formation is accomplished in a manner similar to that of RBC diluent formation as detailed above, except that it utilizes a WBC reagent syringe pump 220 and a WBC chamber 310, and the predetermined volume and number of pulses can be different.

[0136] The third stage of sample processing is diluent handling, which includes WBC diluent transport, WBC diluent acquisition, cleaning of sample probe 110 and refilling of sample syringe pump 210, RBC diluent transport, and RBC diluent acquisition. WBC diluent transport is initiated by robotic assembly 100, which moves carrier 102 to move diluent probe 120 in the y-direction to y-axis alignment with WBC chamber 310 of mixing assembly 300. Next, peristaltic pump 400 aspirates air through the diluent transport line to clean the line. Once the line is clean, robotic assembly 100 moves carrier 102 to extend diluent probe 120 into and to the bottom of WBC chamber 310. Then, peristaltic pump 400 aspirates WBC diluent through hemoglobin detection unit 610 and toward flow unit 810 of flow cytometer assembly 800.

[0137] WBC diluent acquisition is accomplished by performing the dispensing of WBC diluent (via sample syringe pump 210) and sheath flow (via sheath syringe pump 240) to flow unit 810 in parallel. This dispensing sets and stabilizes the wick flow through flow unit 810 to facilitate data acquisition using the wick flow of flow cytometer assembly 800. Regarding sheath flow delivery, this dispensing can be achieved by first dispensing a first volume of sheath flow to flow unit 810 at a first rate, and then dispensing different second volumes of sheath flow to flow unit 810 at a second different rate. Regarding sample delivery, a first volume of sample is initially delivered to flow unit 810 at a first rate, followed by a second volume of sample at a second rate, and then a third volume of sample at a third rate. After a predetermined delay following the completion of the second sample delivery / start of the third sample delivery, the laser optics of flow cytometer assembly 800 are activated to begin data acquisition. The laser optics of flow cytometer assembly 800 are deactivated after the third delivery is completed to end data acquisition. The sample and sheath flow passing through the flow unit 810 continue to travel to the sheath flow and waste pack 30.

[0138] Once the WBC diluent acquisition is complete as detailed above, the robot assembly 100 translates the carrier 102 to move the diluent probe 120 in the z-direction to withdraw the diluent probe 120 from the WBC chamber 310.

[0139] The cleaning of sample probe 110 and the refilling of sample syringe pump 210 initially involve peristaltic pump 400 aspirating any residual fluid in cleaning chamber 330 into sheath flow and waste bag 30, and robotic assembly 100 translating carrier 102 to move sample probe 110 in the y-direction to y-axis alignment with cleaning chamber 330. With sample probe 110 positioned in this position, the following actions are performed in parallel: sheath syringe pump 240 is activated to pump sheath flow through sample probe 110 and into cleaning chamber 330; robotic assembly 100 translates carrier 102, thereby moving sample probe 110 to the bottom of cleaning chamber 330; and peristaltic pump 400 is activated to aspirate fluid from cleaning chamber 330, thereby emptying cleaning chamber 330 into sheath flow and waste bag 30. These parallel actions clean the interior of sample probe 110 and also flush the interior of cleaning chamber 330. Following this cleaning, refilling of the sample syringe pump 210 is accomplished by activating the sheath syringe pump 240 to distribute sheath flow through the sample probe 110 and into the cleaning chamber 330 (e.g., in the embodiment) to substantially fill the cleaning chamber 330, and the sample syringe pump 210 is activated to draw sheath flow from the cleaning chamber 330 into the sample probe line, thereby refilling the line for subsequent RBC diluent delivery and retrieval. Finally, the robotic assembly 100 translates the carrier 102 to move the diluent probe 120 in the z-direction to withdraw the diluent probe 120 from the cleaning chamber 330.

[0140] In parallel with the cleaning of sample probe 110 and the refilling of sample syringe pump 210, or at any other suitable point during the run sequence, hemoglobin assembly 600 acquires WBC diluted sample readings still in hemoglobin detection unit 610 from the aforementioned dilution delivery.

[0141] Continue with overall reference Figure 6 and combined Figure 1 , Figures 3 to 5 , Figure 7 , Figure 8 , Figure 14A , Figure 14B and Figure 30RBC diluent acquisition is performed in a manner similar to WBC diluent formation detailed above, except that RBC chamber 320 is used and some fluid volumes and flow rates can be different. Specifically, RBC diluent acquisition involves dispensing RBC diluent into flow unit 810 (via sample syringe pump 210) and dispensing sheath flow into flow unit 810 in parallel (via sheath syringe pump 240). More specifically, this dispensing can be achieved by first dispensing a first volume of sheath flow into flow unit 810 at a first rate, and then dispensing a different second volume of sheath flow into flow unit 810 at a second, different rate. Regarding sample transfer, a first volume of sample is initially transferred to flow unit 810 at a first rate, followed by a second volume of sample to flow unit 810 at a second rate, and then a third volume of sample to flow unit 810 at a third rate. After a predetermined delay following the completion of the second sample delivery / start of the third sample delivery, the laser optics of the flow cytometer assembly 800 are activated to begin data acquisition. The laser optics of the flow cytometer assembly 800 are deactivated after the third delivery to end data acquisition. The sample and sheath flow through the flow unit 810 continue to the sheath flow and waste package 30. Finally, the robotic assembly 100 translates the carrier 102 to move the dilution probe 120 in the z-direction to withdraw the dilution probe 120 from the RBC chamber 320.

[0142] The fourth stage of sample run, cleaning, involves: emptying chambers 310, 320, and 330 of the mixing assembly 300, refilling reagent syringe pumps 220 and 230, rinsing and cleaning chamber 330, cleaning diluent probe 120, cleaning flow unit 810, cleaning red blood cell chamber 320, and cleaning WBC chamber 310.

[0143] Peristaltic pump 400 draws in air to remove any residual diluent from the diluent probe line and draws any remaining fluid from WBC chamber 310, RBC chamber 320, and / or clean chamber 330 into the sheath stream and waste pack 30, thereby emptying chambers 310, 320, and 330. Refilling of reagent syringe pumps 220 and 230 is provided by activating WBC reagent syringe pump 220 and RBC reagent syringe pump 230 to draw reagent from reagent pack 40 into the corresponding syringe pumps 220 and 230.

[0144] The flushing of the cleaning chamber 330 is then performed by the robotic assembly 100 through the following steps: First, the carrier 102 is translated to move the sample probe 110 in the y-direction until it is aligned with the y-axis of the cleaning chamber 330; then, in parallel, the sheath injector pump 240 pumps a sheath flow through the sample probe line and into the cleaning chamber 330; the robotic assembly 100 translates the carrier 102 to move the sample probe 110 in the z-direction to advance the sample probe 110 to the bottom of the cleaning chamber 330; and the peristaltic pump 400 aspirates fluid from the cleaning chamber 330 into the sheath flow and waste bag 30. Thereafter, the robotic assembly 100 translates the carrier 102 to withdraw the sample probe 110 from the cleaning chamber 330 in the z-direction. In some embodiments, the above flushing may be repeated once or more.

[0145] Next, regarding the cleaning of the diluent probe 120, the robot assembly 100 translates the carrier 102 to move the diluent probe 120 in the y-direction until it is aligned with the cleaning chamber 330 along the y-axis, and then moves it in the z-direction to the bottom of the cleaning chamber. Thereafter, in parallel, the sheath injector pump 240 pumps the sheath flow through the diluent probe line and into the cleaning chamber 330, and the peristaltic pump 400 draws fluid from the cleaning chamber 330 into the sheath flow and waste bag 30. In some embodiments, the above-described flushing may be repeated once or more.

[0146] To perform flow unit cleaning, sheath injector pump 240 distributes a sufficient volume of sheath flow into cleaning chamber 330; in some embodiments, cleaning chamber 330 is substantially filled. Subsequently, peristaltic pump 400 draws the sheath flow from cleaning chamber 330 through diluent probe tubing into flow unit 810. In parallel, sample injector pump 210 and sheath injector pump 240 distribute sheath flow into flow unit 810. In some embodiments, the above flushing may be repeated once or more. After this flushing, peristaltic pump 400 draws fluid from cleaning chamber 330 into sheath flow and waste bag 30, and robotic assembly 100 translates carrier 102 to withdraw diluent probe 120 from cleaning chamber 330 in the z-direction.

[0147] Cleaning the RBC chamber 320 involves the robotic assembly 100 translating the carrier 102 to move the sample probe 110 in the y-direction until it is aligned with the RBC chamber 320 along the y-axis, and then in the z-direction such that the output of the sample probe 110 is slightly below the top of the RBC chamber 320. Once this position is reached, the sheath injector pump 240 pumps the sheath through the sample probe line to substantially fill (or dispense another volume) the RBC chamber 320, and the peristaltic pump 400 aspirates fluid from the RBC chamber 320 into the sheath flow and waste bag 30. This flushing process may be repeated once or more. Finally, the robotic assembly 100 translates the carrier 102 to move the sample probe 110 in the z-direction to withdraw the sample probe 110 from the RBC chamber 320.

[0148] The cleaning of the WBC chamber 310 is performed in a similar manner to the cleaning of the RBC chamber 320 described above, except that the WBC chamber 310 is used and, after rinsing, the robotic assembly 100 moves the carrier 102 to return to its original position. Therefore, the analyzer 10 is reset for subsequent sample runs, which are performed by repeating the run sequence described above.

[0149] Special Reference Figure 14B The operating sequence detailed above is substantially the same as the operating sequence of the fluid from the onboard control tube 80 (except, for example, using a different dilution ratio), which contains synthetic particles suspended in the fluid. These control runs can be performed periodically at intervals (elapsed time intervals, usage time intervals, daily time intervals, run number intervals, etc.) based on requests and / or the occurrence of one or more conditions (movement threshold, temperature change threshold, extended inactivity threshold, component replacement, etc.). The onboard control tube 80 is configured to remain in the analyzer 10 after multiple runs, and thus, a motor (not explicitly shown) is provided in drawer 60 to rotate the control tube 80 and mix the contents before the sample from it is used in the control running sequence. If necessary, the operating sequence of the fluid from the onboard control tube 80 is used to check calibration and perform self-calibration.

[0150] The analyzers, apparatuses, systems, and / or methods described herein can utilize one or more controllers to receive various information and transform the received information to generate output. The controllers can include any type of computing device, computing circuitry, or any type of processor or processing circuitry capable of executing a series of instructions stored in memory. The controllers can include multiple processors and / or multi-core central processing units (CPUs) and can include any type of processor, such as a microprocessor, digital signal processor, microcontroller, programmable logic device (PLD), field-programmable gate array (FPGA), etc. The controllers can be located within an apparatus or system at an end-user location, at a manufacturer's or service provider's location, or as a cloud computing processor located at a cloud computing provider's location. The controllers can also include memory to store data and / or instructions that, when executed by the one or more processors, cause the one or more processors to execute one or more methods and / or algorithms.

[0151] It will be understood that various modifications can be made to the aspects and features disclosed herein. Therefore, the foregoing description should not be construed as restrictive, but only as examples of various aspects and features. Those skilled in the art will contemplate other modifications within the scope and spirit of the appended claims.

Claims

1. An analyzer, comprising: Inner chassis; The housing surrounding the inner chassis; A sample probe, which is operably coupled to the inner chassis within the housing and is movable relative to the inner chassis; A diluent probe, which is operably coupled to the inner chassis within the housing and is movable relative to the inner chassis; A mixing housing supported on an inner chassis within the housing, the mixing housing defining a first mixing chamber and a second mixing chamber, each of the first mixing chamber and the second mixing chamber being configured to receive a dilution stream; A flow cytometer, wherein the flow cytometer is supported on an inner chassis within the housing, and the flow cytometer includes a flow unit; A sample pump, disposed within the housing and configured to perform a first set of tasks, the first set of tasks including: aspirating a sample into the sample probe; dispensing a sample from the sample probe into a first mixing chamber; dispensing a sample from the sample probe into a second mixing chamber; delivering a first sample dilution mixture to the flow unit; and delivering a second sample dilution mixture to the flow unit; A sheath pump, disposed within the housing and configured to perform a second set of tasks, the second set of tasks including: dispensing a sheath into the flow unit in a manner cooperating with delivering the first sample dilution mixture to the flow unit; and dispensing a sheath into the flow unit in a manner cooperating with delivering the second sample dilution mixture to the flow unit; and A carrier member supports the sample probe and the diluent probe in a fixed orientation relative to each other. The carrier member is operably coupled to the inner chassis within the housing and is movable relative to the inner chassis, thereby moving both the sample probe and the diluent probe in the fixed orientation to operably position the sample probe to perform a first subset of the first set of tasks and a second set of tasks, and to operably position the diluent probe to perform a different second subset of the first set of tasks and the second set of tasks.

2. The analyzer of claim 1 further includes a robotic assembly configured to manipulate the carrier relative to the inner chassis in the y and z directions to position the sample probe and the diluent probe to perform at least some of the first set of tasks and the second set of tasks.

3. The analyzer according to claim 2, wherein, The robot assembly also includes y-axis and z-axis potentiometers configured to perform feedback-based control on the movement of the carrier in each of the y and z directions.

4. The analyzer according to claim 1 further includes a first diluent pump and a second diluent pump, the first diluent pump and the second diluent pump being disposed within the housing and configured to respectively deliver the diluent stream to the first mixing chamber and the second mixing chamber.

5. The analyzer of claim 1, further comprising a peristaltic pump configured to perform a third set of tasks, the third set of tasks including: The first sample dilution stream from the first mixing chamber is aspirated into the dilution probe; The second sample dilution stream from the second mixing chamber is aspirated into the dilution probe; the first sample dilution stream mixture is aspirated through the dilution probe in preparation for delivery to the flow unit; the second sample dilution stream mixture is aspirated through the dilution probe in preparation for delivery to the flow unit; the remaining fluid in the first mixing chamber is aspirated for disposal; and the remaining fluid in the second mixing chamber is aspirated for disposal.

6. The analyzer according to claim 1, wherein, The second set of tasks further includes: dispensing a sheath into the first mixing chamber to clean the first mixing chamber; and dispensing a sheath into the second mixing chamber to clean the second mixing chamber.

7. The analyzer according to claim 1, wherein, The hybrid housing also defines a cleaning chamber, and the second set of tasks further includes dispensing a sheath into the cleaning chamber to clean a portion of the sample probe disposed therein.

8. The analyzer according to claim 1 further includes a hemoglobin detection component, wherein the hemoglobin detection component is arranged in parallel with the flow unit.

9. The analyzer of claim 1 further includes a fluid circuit configured to control the flow of a sheath therethrough, the fluid circuit being disposed within a sheath flow line such that a sheath distributed to the flow unit passes through the fluid circuit.

10. The analyzer of claim 1, further comprising a drawer providing selective access through the housing to the inner chassis for selective insertion and removal of a sample tube containing a sample.

11. The analyzer according to claim 1 further includes a fluid capacitor-filter-resistor circuit, the fluid capacitor-filter-resistor circuit being disposed within the sheath flow line such that the sheath distributed to the flow unit passes through the fluid capacitor-filter-resistor circuit.

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