Blood testing system and method

Abstract

Some embodiments of a blood coagulation testing system include an analyzer console device and a single-use cartridge component configured to be releasably mounted into the console device. In some embodiments, the blood coagulation testing system can operate as an automated thromboelastometry system that is particularly useful at point-of-care settings, for example.

Description

[0001] This application is a divisional application of Chinese Patent Application No. 201680074338.9, filed December 2, 2016, entitled "Blood Testing System and Method."

[0002] Cross Reference to Related Applications

[0003] This application claims the benefit of U.S. Patent Application No. 14 / 958,890, filed December 3, 2015, which is a continuation-in-part of U.S. Patent Application No. 14 / 500,248, filed September 29, 2014, the entire contents of which are incorporated herein by reference for all purposes. TECHNICAL FIELD

[0004] This document relates to systems and methods for testing properties of blood samples, such as automated thromboelastometry systems for whole blood clotting analysis for point-of-care testing. BACKGROUND

[0005] Hemostasis is the body's response to blood vessel injury and bleeding. Hemostasis involves a coordinated effort between platelets and many clotting proteins (or clotting factors) that results in the formation of a clot and, subsequently, the cessation of bleeding.

[0006] Various methods have been introduced to assess the potential of blood to form a sufficient clot and to determine the stability of the clot. Common laboratory tests, such as platelet counts or assays for fibrin concentration, provide information on whether the measured components are available in sufficient amounts, but some of these tests can not answer the question of whether the measured components work properly under physiological conditions. Other laboratory tests are performed on plasma, which can require additional preparation steps and additional time, beyond what is desirable, for example, in the context of point-of-care testing (e.g., in a surgical operating room during a surgical procedure).

[0007] Another group of tests that assess the potential of blood to form a sufficient clot are called "viscoelastic methods." In at least some viscoelastic methods, the blood clot stiffness (or other parameters that depend on the stiffness) is determined during a time period that, for example, extends from the formation of the first fibrin fibers until the dissolution of the fibrin clot. Blood clot stiffness is a functional parameter that contributes to hemostasis in vivo, because the clot has to resist the blood pressure and shear stress at the site of the blood vessel injury or incision. In many cases, the clot stiffness can result from a variety of interrelated processes, including coagulation activation, thrombin formation, fibrin formation and polymerization, platelet activation, and fibrin-platelet interaction.

[0008] To isolate and test specific functions of platelets, fibrinogen, and other factors in a blood sample, reagent compounds can be mixed with the blood sample to activate or inhibit certain components in the blood sample. In some commercially available point-of-care blood testing systems, liquid reagents are injected into a single-use plastic cup containing a blood sample, and then the cup is engaged by a control console of the blood testing system to evaluate the coagulation / clotting properties of the blood sample. As part of the testing process, the system requires manual intervention by an operator for each assay in the test, for example, when a pipette is used by the operator for the dispensing and measurement of reagents, blood, and mixed samples. SUMMARY

[0009] Some embodiments of a system for testing properties of a blood sample (which should be understood herein to include blood or a blood derivative such as plasma) can include a cartridge configured to mate with a control console and receive a blood sample for point-of-care whole blood coagulation analysis. In particular cases, the cartridge is configured to interact with the control console to perform multiple automated transport and testing operations on a portion of the blood sample in order to provide reliable and rapid results indicative of the blood properties of a patient (e.g., while the patient is undergoing surgery in an operating room). For example, the system can be used as an automated thromboelastometry system for initiating an automated testing process in response to receiving the cartridge (and a blood sample at the cartridge) and an indication from an operator to provide detailed and rapid results of blood coagulation properties.

[0010] In some embodiments, a thromboelastometry system includes a reusable analyzer control console and one or more single-use cartridge components configured to mate with the control console. In one example, to operate the thromboelastometry system, a user inserts a cartridge into the analyzer control console and, when prompted by the analyzer control console, inserts a blood collection tube (containing a whole blood sample) into a receiver portion of the cartridge. The user is then prompted by a user interface of the analyzer control console to initiate a number of automated blood transport and testing operations. Thereafter, the analyzer control console automatically performs (without requiring additional user interaction with the cartridge or blood sample) the testing and displays the results on a graphical display using qualitative graphical representations and quantitative parameters. In this particular example, no manual pipetting, mixing, or handling of reagents is required by the user. In some embodiments, four or more assays are automatically performed on a blood sample using a single cartridge device. Such assays provide information about the overall kinetics of hemostasis, such as clotting time, clot formation, clot stability, and lysis; further, such information can be immediately output from a user interface of the system to provide reliable and rapid results indicative of the blood properties of a patient at a point-of-care (e.g., while the patient is undergoing surgery in an operating room).

[0011] Particular embodiments described herein include a cartridge for use with a blood testing station. The cartridge can include a blood sample receiver configured to receive a blood sample to be tested. The cartridge can also include one or more blood processing and testing paths. Each blood processing and testing path can receive a portion of the blood sample and can include a blood sample volume measurement chamber, a mixing chamber, and a viscoelastic blood testing chamber. The blood sample volume measurement chamber can be in fluid communication with the blood sample receiver, and the blood sample volume measurement chamber can be a selected internal volume to contain a predetermined volume of the blood sample from a blood sample container. The mixing chamber can be in fluid communication with the blood sample volume measurement chamber and a reagent, and the mixing chamber can be configured to receive the blood sample from the blood sample volume measurement chamber and mix the received blood with the reagent. The viscoelastic blood testing chamber can be configured to receive the mixed blood and reagent from the mixing chamber for a viscoelastic test of the mixed blood and reagent while the mixed blood and reagent reside in the testing chamber.

[0012] In some embodiments described herein, a cartridge device can include a blood sample receiver and a plurality of blood sample paths in selective fluid communication with the blood sample receiver. Each blood sample path can include: a blood measurement chamber to receive a predetermined amount of a blood sample via the blood sample receiver; a reagent mixing chamber to receive the predetermined amount of the blood sample and mix it with one or more reagents; and a blood clotting blood testing chamber to receive the blood sample mixed with the one or more reagents from the reagent mixing chamber. Optionally, the blood clotting blood testing chamber can have a movable probe therein to measure a blood clotting property.

[0013] Various embodiments described herein include a cartridge device for a measurement system to measure a viscoelastic property of a blood sample. The cartridge can include a blood sample receiver; and at least one blood sample path in selective fluid communication with the blood sample receiver. The blood sample path can include: a blood measurement chamber configured to fill with a predetermined amount of a blood sample via the blood sample receiver; a reagent mixing chamber to receive the predetermined amount of the blood sample from the blood measurement chamber and mix the predetermined amount of the blood sample with one or more reagents; and a blood clotting blood testing chamber to receive the blood sample mixed with the one or more reagents from the reagent mixing chamber, and an overflow chamber in fluid communication with the blood sample path to collect excess blood from the blood measurement chamber beyond the predetermined amount of the blood sample. Optionally, the blood clotting blood testing chamber can have a movable probe therein to measure a blood clotting property.

[0014] Other embodiments described herein include a measurement system for measuring viscoelastic properties of a blood sample. The system can include a control unit housing a viscoelastic measurement component. The control unit can define an external port. The system can also include at least one single-use cartridge including a blood sample input accessible along an exterior of the cartridge and a plurality of blood test chambers positioned along an interior of the cartridge. Optionally, the control unit is configured to releasably mate with the single-use cartridge when inserted into the external port such that the blood sample input of the cartridge remains external to the control unit when the plurality of blood test chambers are positioned within the control unit.

[0015] Some embodiments described herein include a method of using a system for measuring viscoelastic properties of a blood sample. The method can include inserting a single-use cartridge into a blood test console such that a blood sample input remains exposed external. The method can also include attaching a blood sample container to the blood sample input. The method can further include providing user input via a user interface of the blood test console to initiate automatic transport of blood in the blood sample container to a plurality of blood test chambers within the cartridge for measuring viscoelastic properties of the blood in each blood test chamber.

[0016] In particular embodiments described herein, a cartridge device of a measurement system for measuring viscoelastic properties of a blood sample can include a blood sample receiver structure defining a cavity configured to releasably mate with a blood sample reservoir container. The cartridge device can also include a plurality of blood test chambers spaced apart from the blood sample receiver structure and each having a movable probe for measuring blood clotting properties. All of the blood test chambers can be in selective fluid communication with the blood sample receiver structure.

[0017] In some embodiments described herein, a cartridge device of a measurement system for measuring viscoelastic properties of a blood sample can include a plurality of blood test chambers for measuring blood clotting properties. Each of the blood test chambers can be exposed to air and can have a sample input port positioned along a sidewall of the blood test chamber. Optionally, each of the blood test chambers is in fluid communication with an output port of a respective reagent mixing chamber defined in the cartridge device at a height lower than the sample input port of the blood test chamber.

[0018] In various embodiments described herein, a cartridge device of a measurement system for measuring viscoelastic properties of a blood sample can include a plurality of reagent mixing chambers for receiving a predetermined amount of the blood sample and mixing it with one or more reagent beads. The cartridge device can also include a plurality of holding elements that extend into the reagent mixing chambers so as to hold each reagent mixing bead at a predetermined vertical position within the mixing chamber. The holding elements of at least one of the reagent mixing chambers can engage the plurality of reagent mixing beads to hold the plurality of reagent mixing beads spaced apart from one another.

[0019] In particular embodiments described herein, a cartridge device of a measurement system for measuring viscoelastic properties of a blood sample can include a plurality of reagent mixing chambers for receiving a predetermined amount of the blood sample and mixing it with one or more reagent beads. The cartridge device can also include a movable mixing element held together with the reagent mixing chambers. The movable mixing element can include a material that is neutral with respect to the blood sample. The cartridge device can further include a plurality of holding elements that extend into the reagent mixing chambers so as to hold the reagent mixing beads at a position spaced apart from the movable mixing element.

[0020] Some embodiments described herein can include a method for measuring coagulation properties of a blood sample. The method can include detecting a blood test cartridge inserted into a receiver portion of a blood test control unit. The method can also include prompting a user to enter input through a user interface of the blood test control unit to initiate automatic transport of blood in a blood sample container to one or more blood test chambers within the cartridge to measure viscoelastic properties of the blood within each of the blood test chambers. The method can further include automatically transporting a predetermined amount of the blood sample from a blood sample receiver of the blood test cartridge to each of the one or more blood test chambers within the cartridge. Optionally, the method can also include moving a probe in each respective blood test chamber of the cartridge to measure blood coagulation properties. The method can also include displaying results of the measurement of the blood coagulation properties via the user interface.

[0021] Other embodiments described herein include a console for measuring the coagulation properties of blood samples. The console may include a control unit housing that houses at least one interface element configured to releasably house a disposable cartridge (which may optionally have multiple blood test chambers therein, and multiple measuring elements configured to measure the coagulation properties of blood samples in the multiple blood test chambers of the disposable cartridge). The console may also include one or more heating elements positioned near the interface element and configured to heat the cartridge to a predetermined test-related temperature (in some embodiments, e.g., 37 degrees Celsius). The console may also include one or more temperature sensors positioned near the interface element. The control unit may be configured to transport blood to the multiple blood test chambers of the disposable cartridge after the temperature sensors indicate that the multiple blood test chambers of the disposable cartridge have reached the predetermined temperature.

[0022] Some or all of the embodiments described herein may provide one or more of the following advantages. First, some embodiments of the thromboelasticity measurement system are configured to be automated, minimizing user interaction with the system. Therefore, human resources—especially in the context of point-of-care testing such as in the operating room—can be utilized more efficiently. Reduced user interaction also reduces the likelihood of human operator error, such as measurement inaccuracies, reagent mixing errors, etc. Therefore, more accurate thromboelasticity measurement results can be obtained in certain situations.

[0023] Secondly, in some embodiments, the cartridge component includes multiple fluid channels, each individually controllable, allowing multiple different tests to be performed from a single supply of blood sample. For example, each fluid channel includes a dedicated valve and a dedicated vent, controllable by the analyzer console, making blood flow and testing individually controllable for each channel. This feature enables the thromboelasticity measurement system to automate complex testing procedures.

[0024] Third, in some embodiments, the analyzer console can be configured to perform multiple quality control operations / validations to ensure that blood test results are not compromised. For example, the analyzer console can be configured to verify that the blood test cartridge is heated to a target temperature (e.g., approximately 37°C) before the blood sample is dispensed into the test chamber of the cartridge. Since the temperature of the blood sample can affect coagulation properties in some cases, the accuracy of thromboelasticity measurements can be improved as a result of such temperature control operations / validations.

[0025] Fourth, in a specific embodiment of the cartridge device, the geometry of the blood flow path through the fluid channels of the cartridge is configured to reduce the possibility of interfering with the blood (e.g., causing bubble formation, etc.) and / or damaging the blood in a manner that could negatively affect the accuracy of blood test results.

[0026] Fifth, in some embodiments, the blood test kit (and optionally the blood collection storage) may be equipped with one or more computer-readable components to rapidly transmit relevant information from the analyzer console for each blood sample test cycle. For example, each kit may be marked with information such as barcodes, near-field communication tags, and RFID tags, including, but not limited to, the type of test performed by the kit, the type of reagent contained in the kit, manufacturer information, expiration date, etc. In such embodiments, the analyzer console may include a barcode reader (or a reader for near-field communication tags, RFID tags, etc.) that scans the barcode when the kit is inserted into the analyzer console. The analyzer console automatically performs appropriate actions in response to the data read from the barcode. In another example, each blood collection storage device used with the corresponding kit may be marked with information such as barcodes, near-field communication tags, and RFID tags, including, but not limited to, patient information, clinician information, calibration information, etc. (e.g., readable by a corresponding reader device of the analyzer console).

[0027] Sixth, each fluid path of the cartridge may include a mixing chamber containing one or more reagents and a mixing element positioned therein. In some embodiments, the reagents comprise soluble reagent beads. The mixing chambers of the cartridge may be configured to separate one or more reagent beads from each other and prevent the mixing element from direct contact with the reagent beads. Additional advantages associated with the thromboelasticity measurement system provided herein are also foreseeable, as will become apparent from the following disclosure.

[0028] Details of one or more embodiments of the present invention are set forth in the accompanying drawings and the following description. Other features, objects, and advantages of the invention will become apparent from the specification, the drawings, and the claims. Attached Figure Description

[0029] Figure 1A , Figure 1B , Figure 2 and Figure 3 This is a perspective view depicting the components and use of an example thromboelasticity measurement system according to some embodiments.

[0030] Figure 4 yes Figure 1A , Figure 1B , Figure 2 and Figure 3 A perspective view of an example box component of a thromboelasticity measurement system.

[0031] Figure 5 yes Figure 4 Exploded view of the box components.

[0032] Figure 6 yes Figure 4 A partial sectional view of the right side of the box component.

[0033] Figure 7 yes Figure 4 Left side view of the box component.

[0034] Figures 8A-8H This describes some embodiments. Figure 1A , Figure 1B , Figure 2 and Figure 3 A series of schematic diagrams illustrating the operation of the thromboelasticity measurement system.

[0035] Figure 9 This is a schematic diagram of another example thromboelasticity measurement system according to some embodiments.

[0036] Figure 10A yes Figure 4 A top view of the box component.

[0037] Figure 10B yes Figure 10A A partial sectional view of the box component.

[0038] Figure 10C It is a combination Figure 1A , Figure 1B , Figure 2 and Figure 3 The analyzer console of the thromboelasticity measurement system is used to describe the relevant components. Figure 10B A schematic diagram of a partial cross-sectional view of the box component.

[0039] Figure 11 yes Figure 1A , Figure 1B , Figure 2 and Figure 3 An exploded perspective view of the console of the thromboelasticity measurement analyzer of the thromboelasticity measurement system.

[0040] Figure 12 It is a schematic depiction Figure 1A , Figure 1B , Figure 2 and Figure 3 A block diagram of the subsystem of the thromboelasticity measurement analyzer control console of the thromboelasticity measurement system.

[0041] Figure 13 This is a flowchart of a method for using a thromboelasticity measurement system according to some embodiments.

[0042] Figure 14A and Figure 14B This is a flowchart of a method for controlling a thrombus elasticity measurement system according to some embodiments.

[0043] Similar reference numerals in the various figures indicate similar elements. Specific Implementation

[0044] refer to Figures 1A-3 Some embodiments of the blood testing system 100 include an analyzer console 140 and one or more cartridges 120 configured to releasably mate with the analyzer console 140. In this embodiment, the blood testing system 100 is a thromboelasticity measurement system configured to determine multiple blood coagulation properties of a blood sample input into the cartridge 120. For example, the cartridge 120 may be configured as a single-use cartridge including a blood sample receiver 122 for mating with a blood sample reservoir 10 (e.g., a vacuumer sample tube supplied by Becton, Dickinson & Company of Franklin Lakes, NJ, or another blood reservoir configuration). In some cases, an adapter may be used to couple other types of blood sample reservoirs 10 to the cartridge 120 (e.g., a tube may be used through which blood can be injected into the cartridge 120, etc.). The thromboelasticity measurement system 10 can be used as a whole blood coagulation analysis system, which is particularly advantageous in locations requiring point-of-care testing (e.g., in a surgical operating room when a patient is undergoing or preparing for surgery, etc.). In addition, the thromboelasticity measurement system 100 can be used as a whole blood coagulation analysis system in a laboratory environment.

[0045] The analyzer console 140 includes a user interface 142 (in this embodiment, a touchscreen display) and a main chassis 144. The user interface display 142 can be configured to output one or more graphical results 143 (e.g., one or more graphs, such as sometimes referred to as TEM plots, digital data, or measurements, or combinations thereof) from blood testing performed via cartridge 120 and console 140. In some embodiments, the user interface display 142 is rigidly attached to the analyzer console 140. In certain embodiments, the user interface display 142 is pivotable and / or otherwise positionally adjustable relative to the main chassis 144. A main power switch 148 can be positioned in a convenient but protected location on the main chassis 144.

[0046] In the depicted embodiments, the touchscreen display 142 is configured to receive user input and display output information to the user. For example, a user can input information into the thromboelasticity measurement system 100 by selecting various soft buttons that can be displayed on the touchscreen display 142 during the start, middle, and end of the testing process. In some embodiments, other options, such as, but not limited to, soft keyboard input, may be provided via the touchscreen display 142. In some embodiments, data input may be performed additionally or alternatively via voice input. In other embodiments, the user interface may include other peripheral devices (e.g., mouse, keyboard, additional display device, etc.) that may be included as part of the thromboelasticity measurement system 100. In some embodiments, a computer data network (e.g., intranet, Internet, LAN, etc.) may be used to allow remote devices to receive and / or input information from the system 100. For example, in some embodiments, one or more remote displays may be utilized via a network connection. In the depicted embodiments, the thromboelasticity measurement system 100 also includes an external barcode reader 146. External barcode reader 146 can facilitate convenient one-dimensional or two-dimensional barcode data input, such as, but not limited to, blood sample data, user identification, patient identification, normal values, etc. Alternatively or additionally, thromboelasticity measurement system 100 may be equipped with a reader configured to read near-field communication tags, RFID tags, etc.

[0047] In the depicted embodiments, the main chassis 144 houses various internal subsystems (described further below), including various electronic connection jacks (not shown), and includes a housing port 150. These electronic connection jacks may include network and device connectors, such as, but not limited to, one or more USB ports, Ethernet ports (e.g., RJ45), VGA connectors, Sub-D9 connectors (RS232), etc. Such connection jacks may be located at the rear of the main chassis 144, or at other convenient locations on the main chassis 144. For example, in some embodiments, one or more USB ports may be located on or near the front of the main chassis 144. For example, such a USB port location may provide user convenience for recording data to a memory stick. In some embodiments, the thromboelasticity measurement system 100 is configured to operate using wireless communication modes, such as, but not limited to, Wi-Fi, Bluetooth, NFC, RF, IR, etc.

[0048] Still referencing Figures 1A-3The cassette port 150 can be positioned at an easily accessible location on the main frame 144. In the depicted embodiment, the cassette port 150 is positioned at the front of the main frame 144, making it easily accessible to users in the point-of-care testing location. The cassette port 150 defines an opening and an internal space shaped to complement the external dimensions of the disposable cassette 120. To insert the disposable cassette 120 into the cassette port 150, a user can grasp one end of the cassette 120, which includes the blood sample receiver 122, and slide the other end (front end) into the cassette port 150. Sliding insertion can continue until a hard stop is reached defining a fully inserted position. In the fully inserted position, the rear portion of the disposable cassette 120 (including the blood sample receiver 122 in this embodiment) remains outside the main frame 144. The portion of the cassette 120 received in the cassette port 150 may include external surface features (such as...) that mate with at least one internal interface element within the console 140. Figure 1B The tapered rear portion (shown as shown) ensures proper positioning of the cartridge 120. Thus, at least the blood sample receiver 122 remains outside the main frame 144 throughout the entire duration of the blood sample test. In this configuration, the blood sample receiver 122 serves as an accessible blood sample well, allowing the blood sample container 10 to be inserted into the receiver 122, while the disposable cartridge 120 mates with the console 140 in the fully inserted position. In some embodiments, the cartridge port 150 and the main frame 144 are configured such that exposed portions of the cartridge 120 are protected from accidental contact. As further described below, internal sensors (e.g., microswitches, optical sensors, etc.) can detect when the disposable cartridge 120 has been fully inserted into the main frame 144.

[0049] When the analyzer console 140 has detected that the cartridge 120 has been fully inserted, in some embodiments, the analyzer console 140 initiates one or more of the following actions: An internal cartridge clamping mechanism, including a locating pin, can be activated to precisely position and releasably hold the disposable cartridge 120 in the fully inserted position. One or more cartridge heating elements can be activated to heat the cartridge 120. The temperature of the cartridge 120 can be monitored. A barcode on the front end of the cartridge 120 can be read, and the barcode data can be stored in the memory of the analyzer console 140. One or more blood testing sensors can check for the presence of blood in the cartridge 120 (which should not be present at this time). A rotating thrombus measurement subsystem can engage with the cartridge 120, and optionally, the rotating thrombus measurement subsystem can begin rotation (in the absence of blood). The cartridge 120 can be leak-tested using vacuum or air pressure delivered by the analyzer console 140. For example, a pressure / vacuum decay test can be performed. In some embodiments, other actions can be additionally or alternatively activated when the analyzer console 140 has detected that the cartridge 120 has been fully inserted. After these actions are completed, in some embodiments, an indication of the result of the action can be displayed on the touchscreen display 142 (e.g., pass or fail). If the analyzer console 140 determines that the action has been successfully completed, a prompt can be provided on the touchscreen display 142 to notify the user that the thromboelastomer measurement system 100 is ready to receive the blood sample storage unit 10.

[0050] Briefly, in some embodiments, the user can operate the described thromboelasticity measurement system 100 as follows. First, the user inserts the disposable cartridge 120 into the cartridge port 150, such that the cartridge 120 is in the fully inserted position. As described below, this step automatically initiates a series of operations of the thromboelasticity measurement system 100. After these operations are successfully completed, a notification that the blood collection tube 10 can be inserted into the sample well 122 will be displayed on the touchscreen display 142. After the user inserts the blood collection tube 10 into the sample well 122, the user starts the test by pressing the "Start" button (or similar) on the touchscreen display 142. Thereafter, at least blood measurement, reagent mixing, and the thromboelasticity measurement test are performed automatically by the system 100 (e.g., in this embodiment, no manual intervention from the user is required). When the test is complete, the results are displayed on the touchscreen display 142 in the form of a qualitative graphical representation and quantitative parameters (e.g., as shown in the image). Figure 1A (As shown). Additionally, when the test is complete, the cartridge 120 can be removed from the console 140 and discarded (e.g., in such an embodiment, the cartridge 120 is not reusable because the reagent beads (described below) are no longer present in the cartridge, and the measuring chamber contains the coagulated blood sample portion).

[0051] Alternatively, in some embodiments, the blood collection tube 10 may be inserted into the sample well 122 of the cartridge 120 before the cartridge 120 is inserted into the cartridge port 150. In this case, blood from the collection tube 10 may not proceed to the measuring chamber of the blood cartridge 120 until after the console 140 has acted on the cartridge 120 (described below) (again, described below). With the blood collection tube 10 pre-coupled to the cartridge 120, the combination of the blood collection tube 10 and the cartridge 120 may then be inserted into the cartridge port 150.

[0052] Now for reference Figure 4 and Figure 5 The illustrated embodiment of the disposable box 120 includes a main body 124, a right cover 126, a left cover 128, and five pins 138a, 138b, 138c, 138d, and 138e. The right cover 126 is fixed to the right side of the main body 124, and the left cover 128 is fixed to the left side of the main body 124. Thus, the right cover 126 and the left cover 128 surround the cavity and flow channel of the main body 124 to define the blood flow path, as further described below. The sample well 122 described above is part of the main body 124. However, other configurations of the disposable box 120 are also conceivable.

[0053] In some embodiments, the body 124, right cover 126, left cover 128, and pins 138a, 138b, 138c, 138d, and 138e are manufactured by injection molding. After molding, the right cover 126 and left cover 128 can be attached to the body 124 using various techniques, including but not limited to: ultrasonic welding, laser welding, solvent bonding, adhesive bonding, UV-curable adhesive bonding, etc. Various polymer materials can be used to construct the body 124, right cover 126, left cover 128, and pins 138a to 138e. For example, such polymer materials can include, but are not limited to: acrylic acid, polycarbonate, polyvinyl chloride (PVC), polyethylene, polypropylene, polymethyl methacrylate, polystyrene, acrylonitrile butadiene styrene (ABS), polyethylene, polypropylene, etc., and combinations thereof. In some embodiments, materials are used to construct the body 124, right cover 126, and left cover 128, and pins 138a to 138e comprise acrylic acid-based polymer compounds. In some embodiments, the body 124, the right cover 126, and the left cover 128 are substantially transparent, or at least translucent. Therefore, as... Figure 4 As shown, even though the right cover 126 is attached to the main body 124, the features of the main body 124 are still visible.

[0054] In some embodiments, overmolding techniques such as insert molding or multiple molding can be used to construct aspects of the body 124, the right cover 126, and / or the left cover 128 (i.e., device components). For example, a resilient valve element (described further below) can be overmolded in the left cover 128. To generate a valve by overmolding, a first mask is used to generate a device component without a valve. The mask has a shape opposite to that of the device component, which includes an open space for later insertion of a valve. A polymer is poured into the first mask to form a rigid plastic device component. A second mask having a shape opposite to that of the valve is then provided. The hardened plastic device component is placed in the mask, and a resilient material is injected into the open space formed by the first mask in the device component, thereby forming a resilient valve in the device component. In some embodiments, the device component is the body 124, the right cover 126, and / or the left cover 128. Exemplary valves 160a-e, 168, and 170 formed by overmolding in the left cover 128 are... Figure 7 As shown in the figure. In some embodiments, the valve includes an elastomeric material that is deformable when pressure is applied. By applying external pressure to deform the valve, the elastomeric material is pushed into the conduit, thereby fluidly sealing the conduit to prevent sample liquid from flowing through it.

[0055] Furthermore, in some embodiments, minor operations can be performed on the cartridge 120. For example, one or more needles 123a-b (see reference) can be used to puncture the blood collection tube. Figure 6 It can be installed in sample well 122 using a secondary operation.

[0056] The disposable box 120 also includes five pins 138a, 138b, 138c, 138d, and 138e. Pins 138a-e are held within openings in the body 124 (e.g., within test chambers 136a-e (sometimes referred to as “cups”), as follows: Figures 8A-10B (further described) the various component parts (e.g., refer to) Figure 10B The tabs 129 positioned on the right cover 126 and left cover 128 mechanically hold the pins 138a-e in the body 124. However, the pins 138a-e can move freely within a limited range within the boundaries of the body 124. For example, the pins 138a-e can rotate freely and move vertically a few millimeters within the body 124 without restriction. This configuration of the pins 138a-e relative to the other parts of the box 120 can be created as follows. Before the right cover 126 and left cover 128 are secured to the body 124, the pins 138a-e can be placed in their respective positions within the body 124, as follows. Figure 5As shown. With pins 138a-e positioned in the body 124, the right cap 126 and left cap 128 can then be secured to the body 124. With the right cap 126 and left cap 128 secured to the body and pins 138a-e positioned in the body 124, the pins are vertically secured in place by a tab 129 above the top of pins 138a-e, such that pins 138a-e will not detach from or be removed from cups 136a-e without the right cap 126 and left cap 128 being removed from the body 124. Tab 129 allows free rotational movement of pins 138a-e, as well as sufficient vertical movement, to allow pins 138a-e to interact with fluid samples to perform measurements of the viscoelastic properties of the fluid samples in cups 136a-e, such as rotational thromboelasticity measurements. Additionally, tab 129 provides an opening for shaft 310b to couple with pin 138b, as... Figure 10C As shown. In one example, the right cover 126 and the left cover 128 are secured to the body 124, and then the pins 138a-e are pushed into the body 122 via the tabs 129. Even if the box 120 is upside down, the tabs 129 of the right cover 126 and the left cover 128 prevent the pins 138a-e from falling out of the body 122. In some embodiments, the pins and tabs are positioned to prevent semi-solidified fluid samples in the test chamber from leaking out of the test chamber, even when the box 120 is upside down.

[0057] In some embodiments, body 124 includes a barcode location 125. The barcode location 125 can be used as a location for affixing barcode labels or printing barcodes. The barcode location 125 is located at the front end of box 120 (relative to Figures 1 to 1). Figure 3 (The orientation of box 120 inserted into analyzer control console 140 is shown).

[0058] In the described embodiment, the right cover 126 includes blood detection locations 127a and 127b. As will be further described below, blood detection locations 127a and 127b are designated locations where sensors of the analyzer console 140 on the cartridge 120 are mated to the cartridge 120. The sensors detect the presence of blood within the cartridge 120 at blood detection locations 127a and 127b. In some embodiments, the sensors are optical sensors (e.g., infrared sensors), and blood detection locations 127a and 127b are polished areas with enhanced transparency and optical clarity. Thus, the right cover 126 is configured such that the optical sensors of the analyzer console 140 can easily test for the presence or absence of blood at blood detection locations 127a and 127b.

[0059] Now for reference Figure 4 , Figure 5 and Figure 6 In a broad sense, the single-use box 120 is configured to: (i) collect blood from a blood collection tube (e.g., Figure 1 to...)Figure 3 (ii) extracting blood from the blood collection tube 10 and measuring the precise volume of the extracted blood, (iii) mixing the precise amount of blood with reagents, and (iv) delivering the mixture to multiple cup and pin positions in the cartridge 120 for thromboelasticity measurement testing. These steps will be described in more detail below.

[0060] In the depicted embodiments, the disposable cartridge 120 includes five separate blood flow channels 130a, 130b, 130c, 130d, and 130e. Alternatively, in some embodiments, the cartridge includes a single separate blood flow channel, or two separate blood flow channels, or three separate blood flow channels, or four separate blood flow channels, or six separate blood flow channels, or more than six separate blood flow channels. Each channel 130a-e includes: (i) a measuring chamber, (ii) a mixing chamber containing reagents and mixing elements, and (iii) a blood coagulation test chamber (e.g., in this embodiment, having a movable probe / pin therein). For example, channel 130a includes a measuring chamber 132a, a mixing chamber 134a, and a test chamber 136a (refer to...). Figure 10A and Figure 10B (Examples of test chambers are shown in detail below). Similarly, channel 130b includes measurement chamber 132b, mixing chamber 134b, and test chamber 136b; channel 130c includes measurement chamber 132c, mixing chamber 134c, and test chamber 136c; channel 130d includes measurement chamber 132d, mixing chamber 134d, and test chamber 136d; and channel 130e includes measurement chamber 132e, mixing chamber 134e, and test chamber 136e.

[0061] In some embodiments, the sample well 122 includes needles 123a and 123b, which are configured to puncture the septum of the blood collection tube when the blood collection tube is inserted into the sample well 122. Needle 123a is in fluid communication with channels 130a-e, while needle 123b is a vent hole to facilitate the outflow of blood from the blood collection tube.

[0062] In the depicted embodiment, the fluid flow path from needle 123a to channels 130a-e is as follows: Needle 123a merges with measuring chamber 132a. Measuring chamber 132a merges with measuring chamber 132b. Measuring chamber 132b merges with measuring chamber 132c. Measuring chamber 132c merges with measuring chamber 132d. Measuring chamber 132d merges with measuring chamber 132e. Accordingly, blood can flow through needle 123a from the blood collection tube to measuring chamber 132a; from measuring chamber 132a to measuring chamber 132b; from measuring chamber 132b to measuring chamber 132c; from measuring chamber 132c to measuring chamber 132d; and from measuring chamber 132d to measuring chamber 132e. Measuring chambers 132a-e can also be referred to as measurement chambers 132a-e. Each measuring chamber 132a-e has an inlet port and an outlet port. The inlet port is located near the top of the measuring chambers 132a-e. For example, the measuring chamber inlet port 132ai is located near the top of the measuring chamber 132a. This configuration may be advantageous if the blood contains air bubbles, as these gases can be allowed to escape from the blood when it enters the measuring chambers 132a-e. Furthermore, this configuration can advantageously minimize fluid flow turbulence as blood flows into the measuring chambers 132a-e, thereby reducing the possibility of damage to blood cells.

[0063] The outlet ports 134ao-eo for transferring blood from measuring chambers 132a-e to mixing chambers 134a-e are located at the bottom of the measuring chambers. For example, the outlet port 132ao of the measuring chamber is located at the bottom of measuring chamber 132a. In some embodiments, the bottom of measuring chamber 132a slopes downward toward the outlet port 132ao. In some embodiments, the bottom of measuring chamber 132a forms an angle of 2°-15° with a plane parallel to the bottom or top of cartridge 120. In some embodiments, the bottom of measuring chamber 132a forms an angle of 2°-15° with a plane orthogonal to the direction of an applied force to move the blood sample through outlet port 132ao. In one embodiment, the aforementioned angle is approximately 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 11°, 12°, 13°, 14°, or 15°. In a preferred embodiment, the aforementioned angle is 5°, but other angles are also effective. This configuration can help facilitate the complete filling of measuring chambers 132a-e with blood. Because more blood (which may contain air bubbles) is transferred to the outlet port 132ao before the surface of the blood contained in the measuring chamber 132a contacts the outlet port 132ao, it also minimizes the transfer of air bubbles to the outlet port 132ao. Thus, a precise amount of blood is contained within the measuring chambers 132a-e.

[0064] In some embodiments, the top of the measuring chamber 132a is angled such that air escapes from a transfer port located at the top of the measuring chamber opposite the inlet port 132ai. The transfer port is used to transfer air and fluid from the measuring chamber 132a to another measuring chamber (e.g., 132b) or to the overflow chamber 139. In this embodiment, the top of the measuring chamber 132a is angled upwards from a lower point above the inlet port 132ai to a higher point above the transfer port. The angle of the top of the measuring chamber is between 2° and 15° compared to a plane parallel to the bottom or top of the device, or perpendicular to a plane perpendicular to the principal field of gravity exerted on the blood sample in the measuring chamber 132a. In one embodiment, the angle is approximately 2°, 3°, 4°, 5°, 6°, 7°, 8°, 9°, 10°, 11°, 12°, 13°, 14°, or 15°. In a preferred embodiment, the angle is 5°, but other angles are also valid. In a device including a measuring chamber 132a with an angled top, air and air bubbles are conveyed out of the measuring chamber 132a before the blood, thereby providing a reduced amount of air to the measured blood sample that could affect the accuracy of the blood measurement and interfere with other downstream applications. In some embodiments, both the top and bottom of the measuring chamber 132a are angled as described above.

[0065] Based on the preceding description of the fluid flow path from needle 123a to measuring chambers 132a-e and the preceding description of the location of the measuring chamber outlet port, it should be understood that measuring chambers 132a-e will be filled with blood in a sequential manner. That is, the first measuring chamber 132a will be filled with blood; then the blood from measuring chamber 132a will flow to measuring chamber 132b; then measuring chamber 132b will be filled with blood; then the blood from measuring chamber 132b will flow to measuring chamber 132c; then measuring chamber 132c will be filled with blood; then the blood from measuring chamber 132c will flow to measuring chamber 132d; then measuring chamber 132d will be filled with blood; then the blood from measuring chamber 132d will flow to measuring chamber 132e; then measuring chamber 132e will be filled with blood.

[0066] After measuring chamber 132e is filled with blood, the blood from measuring chamber 132e flows to overflow chamber 139. Blood flowing out of measuring chamber 132e enters overflow chamber 139 at overflow chamber inlet port 139i. As will be further described below, overflow chamber 139 serves to ensure that measuring chamber 132e is completely filled while preventing blood from flowing out of box 120 and into the vacuum source used to draw blood into measuring chambers 132a-e, as described above. The vacuum source is fluidly connected to overflow chamber 139 at overflow chamber outlet port 139o. When negative pressure (relative to ambient pressure) from the vacuum source is applied to overflow chamber outlet port 139o, blood from the blood collection tube coupled to needle 123a flows into box 120 to fill all measuring chambers 132a-e. Some blood will also leave measuring chamber 132e and flow to overflow chamber 139.

[0067] As further described below, various valves and vents are distributed throughout the fluid flow path, allowing blood flow to be controlled by the analyzer control console according to a predefined protocol. Additionally, the aforementioned blood detection locations 127a and 127b (see reference) Figure 5 The designated locations on the analyzer console 140 of cartridge 120 are where the sensors dock with cartridge 120. The sensors check for the presence of blood within cartridge 120 at blood detection locations 127a and 127b. Blood sensor location 127a is on the fluid flow path between needle 123a and measuring chamber 132a. When the analyzer console detects blood at blood sensor location 127a, the analyzer console 140 determines that blood has been drawn into cartridge 120. Blood sensor location 127b is on the fluid flow path between measuring chamber 132e and overflow chamber 139. When the analyzer console detects blood at blood sensor location 127b, the analyzer console 140 determines that blood has been drawn into and filled all measuring chambers 132a-e. Furthermore, when the analyzer console 140 detects blood at blood sensor location 127b, the analyzer console 140 can stop applying further negative pressure at the overflow chamber outlet port 139o. In other words, by detecting blood at the blood sensor location 127b, the analyzer console 140 can determine that the vacuum application has successfully filled all measurement chambers 132a-e, and the vacuum application can be stopped. Optionally, the cartridge 120 may be equipped with a blood temperature sensor at or near the blood sensor location 127b to verify that the blood sample is at a predetermined target temperature.

[0068] As described above, each individual channel 130a-e has a measurement chamber 132a-e. In some embodiments, the fluid flow path within a single channel 130a-e is as follows: From the measurement chambers 132a-e, blood can flow to the corresponding mixing chambers 134a-e. For example, blood from measurement chamber 132a can flow to mixing chamber 134a. Similarly, blood from measurement chamber 132b can flow to mixing chamber 134b; blood from measurement chamber 132c can flow to mixing chamber 134c; blood from measurement chamber 132d can flow to mixing chamber 134d; and blood from measurement chamber 132e can flow to mixing chamber 134e. From the mixing chambers 132a-e (after mixing is complete), blood can flow to the respective test chambers 136a-e (which have corresponding probes / pins 138a-e, referred to below). Figure 10A and Figure 10B For example, blood from mixing chamber 134a can flow to test chamber 136a. Similarly, blood from mixing chamber 134b can flow to test chamber 136b; blood from mixing chamber 134c can flow to test chamber 136c; blood from mixing chamber 134d can flow to test chamber 136d; and blood from mixing chamber 134e can flow to test chamber 136e. Various valves and vents, controllable by analyzer control console 140, are distributed within the fluid flow paths of each channel 130a-e. Using these valves and vents, blood flow within a single channel 130a-e can be controlled by analyzer control console 140 according to a predefined scheme.

[0069] Now for reference Figure 6 and Figure 7 The additional features of box 120 will now be described. Figure 6 Side views of specific compartments of box 120 (measuring compartments 132a-e, reagent mixing compartments 134a-e, and blood coagulation testing compartments 136a-e) are provided. Figure 7 In the image, a left-side view of the box 120 and individual channels 130a-e is provided. In this view, the test chamber inlet ports 136ai, 136bi, 136ci, 136di, and 136ei for the test chambers 136a-e are visible. The inlet ports 136ai-ei are positioned, for example, along the side wall of the chambers 136a-e near the top of the test chambers 136a-e, and are positioned at a height above the distal head of the pins 138a-e that interact with the blood sample, but below the proximal end of the pins 138a-e (see reference). Figure 10BThis configuration may be advantageous if the blood contains air bubbles, as it allows these gases to escape from the blood as it enters cups 136a-e. In viscous solutions, if the solution enters through the bottom, air bubbles may be retained at the bottom of cups 136a-e, adversely affecting the measurement of thromboelasticity via pins 138a-e in cups 136a-e. Additionally, this configuration can advantageously minimize fluid flow turbulence as blood flows into test chambers 136a-e. Fluid turbulence and air bubble mixing are also minimized through the sample inlet port 136bi to cups 136a-e, which has a smaller diameter or blood flow area. By using the smaller diameter sample inlet port 136bi, combined with its location along the sidewall of chamber 136a-e, air bubbles present in the blood from mixing chambers 134a-e separate from the fluid and remain on the upper surface of the blood in cups 136a-e. In some embodiments, the diameter of the sample inlet port 136bi is 1 mm. In some embodiments, the diameter of the sample inlet 136bi is approximately 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, or 1.5 mm.

[0070] In the depicted embodiment, the housing 120 includes two locating pin sockets 140a and 140b. The locating pin sockets 140a and 140b are used to engage with locating pins on the analyzer control console 140 (as further described below). In this way, the housing 120 can be precisely positioned relative to the analyzer control console 140.

[0071] The cartridge 120 also includes a vacuum application port 162. When a vacuum source is applied at the vacuum application port 162 and when the vent and valve of the cartridge 120 are properly configured, blood can be drawn into the measuring chambers 132a-e as described above, and further as described below.

[0072] Box 120 also includes a pressure application port 164. When a pressure source is applied at the pressure application port 164 and the vent and valve of box 120 are properly configured, blood can be forced from the measuring chambers 132a-e into the mixing chambers 134a-e, and then from the mixing chambers 134a-e into the test chambers 136a-e as described above, and further as described below.

[0073] In the depicted embodiment, housing 120 further includes vents 166a, 166b, 166c, 166d, and 166e. Other housing embodiments may include fewer or more vents. Vents 166a-e converge with mixing chambers 134a-e, respectively. Thus, when vents 166a-e are open to allow airflow through them, air from mixing chambers 134a-e can be easily displaced as blood flows into them. Conversely, when vents 166a-e are closed to prevent airflow through them, blood flow into mixing chambers 134a-e is prevented because air within them cannot be displaced. Vents 166a-e can be individually opened and closed by analyzer console 140 according to a predefined scheme, as further described below. Thus, the blood flow into mixing chambers 134a-e can be controlled as needed.

[0074] In the depicted embodiment, cartridge 120 also includes valves 168, 170, 160a, 160b, 160c, 160d, and 160e. Other cartridge embodiments may include fewer or more valves. Valves 168, 170, and 160a-e are positioned within the fluid flow path of cartridge 120. Therefore, valves 168, 170, and 160a-e can be actuated (opened or closed) by analyzer console 140 to allow or prevent fluid flow through the fluid flow paths in which valves 168, 170, and 160a-e are respectively positioned. For example, valve 168 is positioned in the fluid flow path between needle 123a and measuring chamber 132a. Therefore, when valve 168 is open, blood can flow from needle 123a to measuring chamber 132a, and when valve 168 is closed, blood cannot flow from needle 123a to measuring chamber 132a.

[0075] Valve 170 is positioned in the fluid flow path between measuring chamber 132e and overflow chamber 139. Therefore, when valve 170 is open, blood can flow from measuring chamber 132e to overflow chamber 139, and when valve 170 is closed, blood cannot flow from measuring chamber 132e to overflow chamber 139.

[0076] Valves 160a-e are respectively positioned in the fluid flow path between mixing chambers 134a-e and test chambers 136a-e. Therefore, when valves 160a-e are open, blood can flow from mixing chambers 134a-e to test chambers 136a-e, and when valves 160a-e are closed, blood cannot flow from mixing chambers 134a-e to test chambers 136a-e.

[0077] As will be further described below, in some embodiments, valves 160a-e can be individually actuated by pins that translate toward and away from valves 160a-e. To close valves 160a-e, the pins can engage with and expand the elastomeric member of valves 160a-e such that the elastomeric member contacts the valve seat of valves 160a-e. When these pins retract from the elastomeric member of valves 160a-e, the elastomeric member will spring back, causing the elastomeric member to cease expansion, and the valve is then opened. In some embodiments, the pins can be translated by a solenoid.

[0078] Other mechanisms may also be present in regulating fluid flow within the regulating chamber 120. For example, a stop connector may be positioned between the measuring chambers 132a-e and the mixing chambers 134a-e to control the flow of blood from the measuring chambers 132a-e to the mixing chambers 134a-e. In some embodiments, the stop connector is a barrier that can be opened when sufficient pressure is applied to it. In some embodiments, the stop connector includes a narrow region for sample fluid flow such that the surface tension of the sample fluid prevents flow through the stop connector unless sufficient pressure is applied. Once sufficient pressure is applied, the flow of sample fluid through the stop connector can continue due to capillary forces.

[0079] For more detailed information, please refer to [link / reference]. Figure 6Some embodiments of mixing chambers 134a-e include: (i) one or more soluble reagent beads 180, (ii) a plurality of retaining elements 182, and (iii) a mixing element 184. One or more reagent beads 180 are disposed and held within the range of the plurality of retaining elements 182. The mixing element 184 is disposed in the bottom portion of the mixing chambers 134a-e and is freely movable horizontally across the bottom portion of the mixing chambers 134a-e. The plurality of retaining elements 182 separate the reagent beads 180 from the mixing element 184 and prevent the mixing element 184 from moving upwards away from the bottom portion of the mixing chambers 134a-e. Therefore, the plurality of retaining elements 182 prevent the mixing element 184 from directly contacting the reagent beads 180 in the mixing chambers 134a-e. Preferably, the retaining element 182 extends into each mixing chamber 134a-e to maintain each reagent bead 180 in a predetermined vertical position within the mixing chamber (e.g., a vertical position below the height at which blood partially flows into the mixing chamber 134a-e), thereby ensuring that each bead 180 is submerged when a predetermined amount of blood is directed into the respective mixing chamber 134a-e. In one embodiment, the height (i.e., the filling level) of the liquid filling the mixing chambers 134a-e from the measuring chambers 132a-e is above the retaining element 182 in the mixing chamber. In some embodiments, the retaining element 182 is above the filling level of the mixing chamber. In these embodiments, the retaining element is configured to position the reagent in the fluid path such that the reagent is dissolved by the liquid as it enters the mixing chamber. In some embodiments, the flow path is defined as the path of liquid flowing from one chamber to another after entering from an inlet or conduit, including within the chamber itself.

[0080] Furthermore, in some embodiments, a plurality of holding elements 182 in each mixing chamber 134a-e hold each reagent bead of reagent beads 180 separately from each other in the respective mixing chamber 134a-e. In such embodiments, each reagent bead of reagent beads 180 does not contact the other beads 180 in the respective mixing chamber 134a-e, does not contact the mixing element 184 in the respective mixing chamber 134a-e, and is held at a vertical height within the respective mixing chamber 134a-e, below the height of the blood portion transported into the respective mixing chamber 134a-e.

[0081] The retaining element 182 may take several unique configurations that result in control of the position of the reagent beads 180. In some embodiments, the retaining element 182 also prevents contact between different reagent beads 180, contact between reagent beads 180 and mixing element 184, and / or contact between reagent beads 180 and other surfaces or components in mixing chambers 134a-e. In some embodiments, the retaining element 182 is configured to restrict movement of reagent beads 180 within mixing chambers 134a-e and is configured to allow sample liquid or blood sample to dissolve reagent beads 180. In some embodiments, the retaining element 182 includes a barrier. The retaining element 182 may also include inward or outward projections in the walls of mixing chambers 134a-e, on the surface of the right cover 126 or left cover 128, or on other surfaces of the device. In some embodiments, the retaining element 182 includes channels, pillars, or recesses. The retaining element 182 may include an array of pillars or an array of recesses. In some embodiments, the array of pillars includes pillars of different diameters to accommodate reagent beads of different diameters. In some embodiments, the retaining element 182 includes a compartment or a series of compartments for retaining the reagent beads. The retaining element 182 may also be configured to both restrict movement of the reagent beads in the mixing chambers 134a-e and allow blood to flow in a manner that contacts and dissolves the reagent beads 180. In some embodiments, the retaining element 182 is configured to allow a blood sample to flow through the mixing chambers 134a-e.

[0082] The retaining element 182 can further secure the reagent bead 180 below the predetermined blood sample filling level in the mixing chambers 134a-e. This filling level is determined by the volume of blood supplied in the measuring chambers 132a-e, the dimensions of the mixing chambers 134a-e, and the volume of components or reagents within the mixing chambers 134a-e during filling. This filling level can be predetermined based on the aforementioned factors. Therefore, the retaining element 182 is specifically designed to hold the reagent bead 180 below this predetermined filling level.

[0083] Furthermore, the holding element 182 can restrict the movement of the mixing element 184 within the mixing chambers 134a-e. In some embodiments, the holding element 182 for restricting the movement of the mixing element 184 within the mixing chambers 134a-e includes an array of columns or compartments that allow sample fluid or blood samples in the mixing chambers 134a-e to come into contact with the mixing element 184, such that the sample fluid or blood samples are agitated to facilitate the dissolution of reagents within the mixing chambers 134a-e.

[0084] In the illustrated embodiment, one or more soluble reagent beads 180 are spherical and have two different sizes (e.g., about 2 mm and about 3 mm in diameter). However, the use of reagent beads 180 of other shapes and / or sizes is also contemplated. In some embodiments, the reagent beads 180 are lyophilized materials, but other forms of materials are also contemplated. The reagent beads 180 may include materials such as, but not limited to, CaCl2, ellagic acid / phospholipids, tissue factor, heparinase, polybrene, cytochalasin D, tranexamic acid, and combinations thereof. The reagent beads 180 can be dissolved in blood. For example, in this particular embodiment, each of the five mixing chambers 134a-e is configured to mix a predetermined volume of blood (defined by the corresponding measuring chamber 132a-e) with different reagent compositions (from one or more reagent beads 180) for the purpose of performing five different tests. In this example, the first mixing chamber 134e may include a plurality of reagent beads 180 providing CaCl2 and ellagic acid / phospholipids for mixing with a predetermined volume of blood (from the corresponding measuring chamber 132e), such that a first sample portion can be used for a first type of test. Similarly, in this example, the second mixing chamber 134d may include a plurality of reagent beads 180 providing CaCl2, ellagic acid / phospholipids, and heparinase for mixing with a predetermined volume of blood (from the corresponding measuring chamber 132d), such that a second sample portion can be used for a second type of test. Furthermore, in this example, the third mixing chamber 134c may include a plurality of reagent beads 180 providing CaCl2, tissue factor, and polybrene for mixing with a predetermined volume of blood (from the corresponding measuring chamber 132c), such that a third sample portion can be used for a third type of test. Similarly, in this example, the fourth mixing chamber 134b may include multiple reagent beads 180 providing CaCl2, tissue factor, polybrene, and cytochalasin D for mixing with a predetermined volume of blood (from the corresponding measurement chamber 132b), such that the fourth sample portion can be used for a fourth type of test. Finally, in this example, the fifth mixing chamber 134a may include multiple reagent beads 180 providing CaCl2, tissue factor, polybrene, and tranexamic acid for mixing with a predetermined volume of blood (from the corresponding measurement chamber 132a), such that the fifth sample portion can be used for a fifth type of test.

[0085] In some embodiments, the reagent bead 180 carrying CaCl2 reagent is separated from the remaining beads 180 in the respective mixing chambers 134a-e to allow mixing first, and then activation / coagulation of the citrate blood sample. This separation of the reagent bead 180 carrying CaCl2 reagent can be achieved using a holding element 182 (as described above). Alternatively, this separation can be achieved by holding the reagent bead 180 carrying CaCl2 reagent in a separate channel or a separate mixing chamber separate from the other beads 180 in the respective chambers 134a-e (such that the blood portion reaches the CaCl2 reagent after mixing with the other beads 180 in the respective mixing chambers 134a-e). Alternatively, this separation can be achieved by placing liquid or dry film CaCl2 reagent in a separate channel such that the blood portion reaches the CaCl2 reagent after mixing with the other beads 180 in the respective mixing chambers 134a-e. Alternatively, the reagent beads 180 carrying CaCl2 reagent may be coated with an additional layer (and then held by the holding element 182 as described above), such that the blood portion begins to dissolve the reagent beads 180 carrying CaCl2 reagent after the blood portion has been pre-mixed with the other beads 180 in the respective mixing chambers 134a-e.

[0086] Other configurations for providing reagents to blood samples may also be used. In some embodiments, the reagent is coated onto the walls of mixing chambers 134a-e. In some embodiments, the reagent is coated onto the right cover 126 or the left cover 128. The reagent coated on the right cover 126 or the left cover 128 may be coated in such a way that it is at least partially or completely contained within the mixing chambers 134a-e. In some embodiments, the reagent is coated such that it is maintained below the fill level of the mixing chambers 134a-e (a fill level related to the height of blood in the mixing chamber, as determined in part by a predetermined volume of blood measured in the measuring chamber). In some embodiments, the coated reagent is a membrane layer, i.e., a reagent membrane. A reagent membrane is a layer of reagent coated on or near a surface. The reagent membrane may be liquid or may be dried. Liquid reagents may be retained as a membrane layer by a layer of soluble material placed on the liquid reagent. Liquid reagent layers may also be applied and then dried on the surface. Pre-dried or solid membrane reagents may also be applied to the surface to form a membrane layer. In some embodiments, the membrane layer is in the form of a soluble membrane strip. In some embodiments, certain reagents are preferably delivered in a reagent membrane rather than in reagent beads 180. For example, certain reagents that are difficult to freeze-dry in reagent beads 180 may instead be applied as a membrane layer to or near the surface of the device.

[0087] In some embodiments, the coated reagent is in the form of reagent beads 180. Retention elements 182 can be used to secure the reagent beads to the wall or lid of the chamber. Retention element 182 may include a series of compartments, pillars, recesses, inward or outward protrusions, or an array of any of the foregoing. Reagents of other shapes or configurations are also contemplated, which may be coated or secured to a lid, the wall of a chamber, or within a fluid passage between chambers. In some embodiments, such as in mixing chambers 134a-e, both reagent beads 180 and reagent films are coated on one or more surfaces of the device.

[0088] A reagent membrane may also be provided for dissolution in a blood sample within mixing chambers 134a-e. The reagent membrane is soluble in blood. The reagent membrane adheres to a surface within mixing chambers 134a-e. In some embodiments, the reagent membrane is deposited on the walls of mixing chambers 134a-e. In some embodiments, the reagent membrane is deposited on the right cover 126 or left cover 128 at least partially covering or forming the walls of mixing chambers 134a-e. The reagent membrane may be used alone or in conjunction with one or more reagent beads 180 placed within mixing chambers 134a-e. Thus, the use of one or more reagent membranes in mixing chambers 134a-e provides an additional mechanism for introducing reagents into mixing chambers 134a-e for dissolution in blood.

[0089] In some embodiments, the reagent membrane comprises a lyophilized material, but other forms of materials are also contemplated. The reagent membrane may include materials such as, but not limited to, CaCl2, ellagic acid / phospholipids, tissue factor, heparinase, polybrene, cytochalasin D, tranexamic acid, and combinations thereof. In a particular example, the reagent beads 180 may be dissolved in blood. For example, in this particular embodiment, each of the five mixing chambers 134a-e is configured to mix a predetermined volume of blood (defined by the corresponding measuring chamber 132a-e) with different reagent compositions (from one or more reagent beads 180 and / or one or more reagent membranes) for the purpose of performing five different tests. In this example, the first mixing chamber 134e may include a plurality of reagent beads 180 providing CaCl2 and ellagic acid / phospholipids and at least one reagent membrane for mixing with a predetermined volume of blood (from the corresponding measuring chamber 132e) such that a first sample portion can be used for a first type of test. Similarly, in this example, the second mixing chamber 134d may include a plurality of reagent beads 180 providing CaCl2, ellagic acid / phospholipids, and heparinase, and at least one reagent membrane for mixing with a predetermined volume of blood (from the corresponding measurement chamber 132d), such that the second sample portion can be used for a second type of test. Furthermore, in this example, the third mixing chamber 134c may include a plurality of reagent beads 180 providing CaCl2, tissue factor, and polybrene, and at least one reagent membrane for mixing with a predetermined volume of blood (from the corresponding measurement chamber 132c), such that the third sample portion can be used for a third type of test. Also in this example, the fourth mixing chamber 134b may include a plurality of reagent beads 180 providing CaCl2, tissue factor, polybrene, and cytochalasin D, and at least one reagent membrane for mixing with a predetermined volume of blood (from the corresponding measurement chamber 132b), such that the fourth sample portion can be used for a fourth type of test. Finally, in this example, the fifth mixing chamber 134a may include a plurality of reagent beads 180 and at least one reagent membrane providing CaCl2, tissue factor, polybrene and tranexamic acid for mixing with a predetermined volume of blood (from the corresponding measuring chamber 132a) so that the fifth sample portion can be used for a fifth type of test.

[0090] Furthermore, a reagent membrane may be deposited on a surface upstream or downstream of the mixing chamber to mix with the blood sample before or after mixing. In some embodiments, the reagent membrane carrying CaCl2 reagent is placed in a separate channel or a separate mixing chamber, separate from other reagent beads 180 or reagent membranes in the respective chambers 134a-e (e.g., such that the blood portion reaches the CaCl2 reagent membrane after being mixed with other reagent beads 180 and / or reagent membranes in the respective mixing chambers 134a-e). Alternatively, the CaCl2 reagent membrane may be deposited in the mixing chambers 134a-e and coated with an additional soluble membrane layer, such that the blood portion begins to dissolve the other reagent membranes carrying CaCl2 reagent after being pre-mixed with other reagent beads 180 or reagent membranes in the respective mixing chambers 134a-e.

[0091] In some embodiments, reagent beads 180 or reagent membranes are separated from the remaining reagent beads 180 or reagent membranes in the respective mixing chambers 134a-e to allow mixing with different reagents in a preferred order. In one embodiment, this separation of reagent beads 180 can be achieved using a retaining element 182 (as described above). Alternatively, this separation can be achieved by retaining reagent beads 180 or reagent membranes in separate channels or separate mixing chambers, separate from the other beads 180 or reagent membranes in the respective chambers 134a-e (so that the blood portion arrives and mixes with the loaded reagents in a preferred order). In one embodiment, this separation can be achieved by placing the reagent liquid, reagent beads 180, or dry film reagent in separate channels, so that the blood portion arrives at the reagent membrane before or after the blood portion mixes with the other reagent beads 180 or reagent membranes in the respective mixing chambers 134a-e. In some embodiments, reagent beads 180 or reagent membranes are placed along a conduit 134ad, which fluidly connects the mixing chambers 134a-e and the test chambers 136a-e. Alternatively, the reagent beads 180 or reagent film may be coated with an additional layer (and then held by the holding element 182 as described above), such that the blood portion begins to dissolve the reagents in the reagent beads 180 or reagent film, including the additional soluble layer, after the blood portion has been pre-mixed with the other reagent beads 180 or reagent films within the respective mixing chambers 134a-e. In some embodiments, the coated reagent layer is a soluble film layer made of a substrate comprising a polymer composition and reagents. The polymer composition forms a soluble barrier to retain the reagents on or near the surface of the device. Upon contact with the blood sample, the polymer composition dissolves to allow the blood sample to mix with the reagents.

[0092] The hybrid element 184 comprises a ferromagnetic material, including but not limited to nickel, cobalt, chromium oxide (IV), gadolinium, permalloy, and aluminum-nickel-cobalt alloys (aluminum-nickel-cobalt alloys), and combinations thereof. In the depicted embodiment, the hybrid element 184 is spherical and solid. In other embodiments, the hybrid element 184 may have shapes such as, but not limited to, cubes, cones, cylinders, sectors, elongated shapes, prisms, and irregular shapes. In some embodiments, the hybrid element 184 may include one or more surface features, such as protrusions, recesses, or holes.

[0093] As will be further described below, in response to movement of the magnet to which the mixing element 184 is magnetically coupled, the mixing element 184 is movable within the mixing chambers 134a-e. The magnet to which the mixing element 184 is magnetically coupled is contained within the analyzer control console 140. Movement of the mixing element 184 causes reagent beads 180 to dissolve in the blood contained within the mixing chambers 134a-e.

[0094] Now for reference Figures 8A-8H An exemplary fluid control process 200 that can be used with the thromboelasticity measurement system provided herein is schematically depicted. Process 200 begins with blood contained only in the blood collection tube 10 and terminates with a blood / reagent mixture contained in cups 136a-e configured for rotating thromboelasticity measurement. It should be understood that, in some embodiments, the cartridge 120 (refer to Figures 1 to 1) for implementing the fluid control process 200... Figure 7 It is heated (e.g., to about 37°C) before it contains any blood.

[0095] refer to Figure 8A Example fluid control process 200 includes a blood collection tube 10, measuring chambers 132a-e, mixing chambers 134a-e and cups 136a-e, an overflow chamber 139, blood detection positions 127a and 127b, a vacuum application port 162, a pressure application port 164, vent ports 166a-e, and valves 168, 170, and 160a-e. In the depicted configuration, valve 168 is closed, thereby substantially retaining the blood within the blood collection tube 10.

[0096] While the example fluid control process 200 includes five blood flow channels (each channel comprising measuring chambers 132a-e, mixing chambers 134a-e, and cups 136a-e, respectively), it should be understood that having five blood flow channels is not required in all embodiments; for example, in some embodiments, only a single blood flow channel is included. Alternatively, two, three, four, six, or more blood flow channels may be included. Reference Figure 8BMeasuring chambers 132a-e are filled with blood, and an overflow chamber 139 contains a small amount of blood. To achieve this state, the following changes were made (with...). Figure 8A Compared to the following conditions: (i) valves 168 and 170 are open, (ii) valves 160a-e are closed, (iii) vent ports 166a-e are closed, (iv) negative pressure is applied to vacuum port 162, and (v) no pressure is applied to pressure port 164. Therefore, blood flows: (i) from the blood collection tube 10, (ii) through valve 168, (iii) through blood detection position 127a, (iv) into and fills measuring chamber 132a, (v) into and fills measuring chamber 132b, (vi) into and fills measuring chamber 132c, (vii) into and fills measuring chamber 132d, (viii) into and fills measuring chamber 132e, (ix) through blood detection position 127b, (x) through valve 170, and (xi) into overflow chamber 139. When blood is detected in blood detection position 127b, the negative pressure is stopped, thus stopping further blood flow.

[0097] In some embodiments, the exemplary fluid control process 200 includes a stop joint 132a between one, some, or each of the measuring chambers 132a-e and the mixing chambers 134a-e. In some embodiments, blood flows through the stop joint 132a in the conduit 132ad connecting the measuring chambers 132a-e and the mixing chambers 134a-e by applying positive pressure to the measuring chamber or applying negative pressure to the mixing chambers 134a-e. The stop joint provides a mechanism to regulate flow without connection to an external control device. Applying positive or negative pressure may create a pressure differential on either side of the stop joint, causing the stop joint to open, or drawing blood through the stop joint by overcoming forces caused by surface tension. A desired pressure may be applied to release pressure in the respective mixing chambers 134a-e via the pressure application port 164 and / or by opening the pressure vent ports 166a-e, allowing blood to flow through the stop joint.

[0098] In some embodiments, the example fluid control process 200 includes a shut-off valve replacing or attached to a stop fitting between one, some, or each of the measuring chambers 132a-e and the mixing chambers 134a-e. In some embodiments, the shut-off valve is a quick-acting valve that opens abruptly when a set pressure is reached, or a regulating valve that opens proportionally to the pressure differential. Other embodiments may include pressure control valves in other fluid paths.

[0099] In some embodiments, the shut-off valve can be used to... Figures 8A-8HThe valves 168, 162, 160a-e shown in the reaction system are opened and closed by the same mechanism. In some embodiments, the shut-off valve can be opened and closed by a mechanism other than applying pressure to the blood. In some embodiments, the shut-off valve is opened according to a remote command from a control device connected to the shut-off valve. In some embodiments, the shut-off valve can be actuated by the analyzer console 140 to allow or prevent fluid flow through the fluid path from the measuring chambers 132a-e to the mixing chambers 134a-e.

[0100] refer to Figure 8C Measurement chambers 132a-d are still filled with blood, but blood from measurement chamber 132e has been transferred to mixing chamber 134e. To achieve this state, the following changes were made (with...). Figure 8B Compared to the conditions in which: (i) valves 168 and 170 are closed, (ii) valves 160a-e remain closed, (iii) vents 166a-d remain closed, (iv) vent 166e is open, and (v) a pressure source is applied to the pressure application port 164. Accordingly, blood flows: (i) out of the measuring chamber 132e, and (ii) into the mixing chamber 134e. Because vents 166a-d and valves 160a-d remain closed, blood in the measuring chambers 132a-d does not flow into the mixing chambers 134a-d. In the presence of blood in the mixing chamber 134e, the mixing element in the mixing chamber 134e can move and agitate the blood to promote the dissolution of the reagent beads therein.

[0101] In some embodiments, Figure 8C The fluid control process shown includes a stop joint (not shown) between measuring chambers 132a-e and mixing chambers 134a-e to prevent blood from flowing from the measuring chambers to the mixing chambers unless a sufficient pressure differential is applied between the measuring chambers 132a-e and the mixing chambers 134a-e. In this embodiment, the stop joint prevents blood from leaking from the measuring chambers 132a-d into the mixing chambers 166a-d without opening the vent ports 166a-d or applying sufficient pressure to the pressure application port 164 to allow blood to flow through the stop joint. To fill the measuring chambers 132e with blood from the mixing chambers 134e, the following changes (with...) are made. Figure 8BCompared to the following conditions: (i) valves 168 and 170 are closed, (ii) valves 160a-e remain closed, (iii) vent ports 166a-d remain closed, (iv) vent port 166e is open, and (v) a pressure source is applied to the pressure application port 164 to allow blood to flow from the measuring chamber 132e through the stop joint into the mixing chamber 134e, while the stop joint between the measuring chambers 132a-d and the mixing chambers 134a-d prevents blood from flowing from the measuring chambers 132a-d into the mixing chambers 134a-d. Using the blood in the mixing chambers 134e, the mixing element in the mixing chambers 134e can move and agitate the blood to promote the dissolution of the reagent beads therein.

[0102] refer to Figure 8D Measurement chambers 132a-d are still filled with blood and are located in mixing chamber 134e (reference). Figure 8C The blood / reagent mixture in the container has been transferred to cup 136e. To achieve this state, the following changes were made (with...). Figure 8C Compared to the following conditions: (i) valves 168 and 170 remain closed, (ii) valve 160e is open, (iii) valves 160a-d remain closed, (iv) vent 166e is closed, (v) vent 166a-d remains closed, and (vi) a pressure source is applied to pressure application port 164. Therefore, the blood / reagent mixture flows: (i) out of mixing chamber 134e, and (ii) into cup 136e. Since vent 166a-d and valves 160a-d remain closed, blood will not flow from measuring chambers 132a-d to mixing chambers 134a-d. With the blood / reagent mixture positioned in cup 136e, rotational thromboelastography can begin in cup 136e.

[0103] refer to Figure 8E Measurement chambers 132a-c are still filled with blood, cup 136e is still filled with a blood / reagent mixture, and measurement chamber 132d (reference) Figure 8D The blood in the mixture has been transferred to mixing chamber 134d. To achieve this state, the following changes were made (with...). Figure 8DCompared to the following conditions: (i) valves 168 and 170 remain closed, (ii) valve 160e is closed, (iii) valves 160a-d remain closed, (iv) vent 166d is open, (v) vents 166a-c and 166e remain closed, and (vi) a pressure source is applied to the pressure application port 164. In an embodiment including a stop joint between measuring chamber 132d and mixing chamber 134d, blood travels through the stop joint by applying a pressure difference between measuring chamber 132d and mixing chamber 134d, while the stop joint between measuring chambers 132a-c and mixing chambers 134a-c prevents flow. Therefore, blood flows: (i) out of measuring chamber 132d and (ii) into mixing chamber 134d. Due to the vents 166a-c and due to the valves 160a-c remaining closed, blood does not flow from measuring chamber 132a-c to mixing chamber 134a-c. In the presence of blood in the mixing chamber 134d, the mixing element in the mixing chamber 134d can agitate the blood to promote the dissolution of the reagent beads therein.

[0104] refer to Figure 8F Measurement chambers 132a-c are still filled with blood, cup 136e is still filled with a blood / reagent mixture, and mixing chamber 134d (reference) Figure 8E The blood / reagent mixture in the sample has been transferred to cup 136d. To achieve this state, the following changes were made (with...). Figure 8E Compared to the following conditions: (i) valves 168 and 170 remain closed, (ii) valve 160d is open, (iii) valves 160a-c and 160e remain closed, (iv) vent 166d is closed, (v) vents 166a-c and 166e remain closed, and (vi) a pneumatic source is applied to the pressure application port 164. Therefore, the blood / reagent mixture flows: (i) out of mixing chamber 134d and (ii) into cup 136d. Since vents 166a-c and valves 160a-c remain closed, blood will not flow from measuring chamber 132a-c to mixing chamber 134a-c. With the blood / reagent mixture positioned in cup 136d, rotational thromboelasticity measurement can begin in cup 136d.

[0105] refer to Figure 8G Measurement chambers 132a-b are still filled with blood, cups 136d-e are still filled with a blood / reagent mixture, and the blood in measurement chamber 132c (refer to...) Figure 8F The signal has been transferred to mixing chamber 134c. To achieve this state, the following changes were made (with...). Figure 8FCompared to the following conditions: (i) valves 168 and 170 remain closed, (ii) valve 160d is closed, (iii) valves 160a-c and 160e remain closed, (iv) vent 166c is open, (iv) vents 166a-b and 166d-e remain closed, and (v) a pressure source is applied to the pressure application port 164. In an embodiment including a stop joint between measuring chamber 132c and mixing chamber 134c, blood travels through the stop joint by applying a pressure difference between measuring chamber 132c and mixing chamber 134c, while the stop joint between measuring chambers 132a-b and mixing chambers 134a-b prevents flow. Therefore, blood flows: (i) out of measuring chamber 132c and (ii) into mixing chamber 134c. Due to vents 166a-b and due to valves 160a-b remaining closed, blood does not flow from measuring chamber 132a-b to mixing chamber 134a-b. When there is blood in the mixing chamber 134c, the mixing element in the mixing chamber 134c can agitate the blood to promote the dissolution of the reagent beads therein.

[0106] refer to Figure 8H The completion of process 200 is depicted. That is, cups 136a-c are entirely filled with the blood / reagent mixture, and rotational thrombus elasticity measurement can be performed in cups 136a-e. As described above, this state can be achieved by actuating valves 168, 170, and 160a-e and vent ports 166a-e, combined with applying a vacuum to vacuum application port 162 or applying pressure to pressure application port 164.

[0107] refer to Figure 9 In some alternative embodiments, one or more of the individual blood flow channels or paths may include multiple mixing chambers arranged in series. For example, example fluid control process 280 includes five blood flow channels (similar to...). Figure 8A -The number of channels in the -H embodiment), but each channel includes two mixing chambers arranged in series (instead of similar to Figure 8A -H embodiment (single mixing chamber for each respective mixing chamber). That is, mixing chambers 137a and 137f are arranged in series between measuring chamber 132a and cup 136a; mixing chambers 137b and 137g are arranged in series between measuring chamber 132b and cup 136b; mixing chambers 137c and 137h are arranged in series between measuring chamber 132c and cup 136c; mixing chambers 137d and 137i are arranged in series between measuring chamber 132d and cup 136d; mixing chambers 137e and 137j are arranged in series between measuring chamber 132e and cup 136e.

[0108] In some embodiments, the reagent bead carrying the CaCl2 reagent is separated from the other reagent bead by placing the CaCl2 reagent in the second of two mixing chambers arranged in series. In this way, the series mixing chambers allow the blood sample to be mixed with the reagent and subsequently initiate the activation / coagulation of the blood sample at controlled time points.

[0109] While the example fluid control process 280 includes five blood flow channels, each comprising two mixing chambers arranged in series, it should be understood that this configuration is not required in all embodiments. For example, in some embodiments, only a single blood flow channel comprising two mixing chambers arranged in series is included in the housing. This single blood flow channel with two mixing chambers may be the only blood flow channel in the housing, or it may be combined in the housing with one or more other blood flow channels comprising a single mixing chamber. It should be understood that all combinations and arrangements of multiple blood flow channels and mixing chambers are included within the scope of this disclosure.

[0110] Now turning more specifically to blood coagulation testing chambers 136a-e, chambers 136a-e can be configured to provide viscoelasticity testing on portions of blood samples drawn into each chamber. Reference Figure 10A and Figure 10B Pins 138a-e are positioned within the housing 120. A representative example of pin 138b positioned within cup 136b shows a gap space between the outer diameter of pin 138b and the inner diameter of cup 136b. When rotational thromboelastography is performed therein, the blood / reagent mixture will at least partially fill the gap space. Pin 138b has a shoulder 138bs. The gap space between the outer diameter of pin 138b and the inner diameter of cup 136b is smaller in the region below shoulder 138bs than in the region above shoulder 138bs. The region between the outer diameter of pin 138b and the inner diameter of cup 136b, located below shoulder 138bs, is the effective region for performing rotational thromboelastography.

[0111] Cup 136b and pin 138b in Figure 10B The middle section is shown in cross-section (according to) Figure 10A Part 10B--10B). Additionally, a sample entry port 136bi (in...) is provided. Figure 10BThe cup inlet port 136bi is positioned behind pin 138b, such that the blood / reagent mixture flows into cup 136b via sample inlet port 136bi. In the depicted embodiment, cup inlet port 136bi is positioned in the sidewall of cup 136b at a height above the widened distal portion of pin 138b (refer to shoulder 138bs) but below the proximal end of pin 138b (refer to the inlet near the axial hole 138bb of pin 138b). In this configuration, the blood / reagent mixture flows into cup 136b, thereby reducing the likelihood of air bubble formation. Furthermore, positioning cup inlet port 136bi near the top of cup 136b eliminates the potential influence of cup inlet port 136bi on thromboelasticity measurements performed in cup 136b when cup inlet port 136bi is positioned in the effective space between the inner diameter of cup 136b and the outer diameter of pin 138b, below shoulder 138bs.

[0112] In some devices, bridging or other structural formation may occur between the cup inlet port 136bi (within the inner diameter of cup 136b) and the outer diameter of pin 138b (i.e., the probe element). This may affect the ability of blood to flow into cups 136a-e, or may lead to errors in thromboelasticity measurements performed in cups 136a-e. In some embodiments, the opening of the inlet port 136bi and the outer diameter of pin 138b are separated by at least a minimum gap distance, which prevents stable bridging or other coagulation structures from forming between the blood sample and the cup inlet port 136bi. At the minimum gap distance, bridging between the sample inlet port and the pin may still occur when filling the test chamber; however, the bridge is not stable enough to persist during measurement. Typically, the bridge will form around the air bubble, which will be unstable if its diameter is equal to or greater than the minimum gap distance. In some embodiments, a stable bridge is one that lasts longer than 1 second, 2 seconds, 3 seconds, 4 seconds, or 5 seconds. In some embodiments, the minimum gap distance is at least 1.5 mm. In some embodiments, the minimum gap distance is at least 1.5 mm, 2 mm, 2.5 mm, or 3 mm. In the illustrated embodiment, as... Figure 10B As shown, the cup inlet port 136bi is positioned in the sidewall of the cup 136b at a height higher than the widened distal portion of the pin 138b (refer to shoulder 138bs) but lower than the proximal end of the pin 138b (refer to the inlet of the axial hole 138bb near the pin 138b), and the inlet port 136bi is at least 1.5 mm from the pin 138b. In other words, because the pin has a narrower portion at the location where bridging may occur, the geometry of the pin allows for this additional clearance, thereby allowing for a larger clearance between the pin and the cup to prevent stable bridging.

[0113] In the depicted embodiment, the top of the cartridge 124 includes a vent 121. The vent 121 is in fluid communication with the needle 123b. Thus, when air is needed to vent the blood sample tube positioned in the sample well 122, air is drawn in through the vent 121 and guided into the blood sample tube via the needle 123b.

[0114] Each pin 138a-e includes an axial bore. For example, pin 138b includes an axial bore 138bb. The axial bore 138bb can be used with a shaft ( Figure 10B (Not shown in the image) is used to perform rotational thrombus elasticity measurement.

[0115] refer to Figure 10C An example rotational thromboelasticity measurement assembly 300b can engage with pin 138b to perform rotational thromboelasticity measurement on a blood sample contained in cup 136b. In this particular embodiment, the example rotational thromboelasticity measurement assembly 300b includes a substrate 302, a shaft 310b, a bearing 312b, a mirror 314b, a reaction spring 320b, a light source 330b, and a detector 340b (e.g., a charge-coupled device or similar). As shown by arrow 318b, the substrate 302 can be lowered such that the tip portion of the shaft 310b enters the aperture 138bb for releasable coupling with pin 138b. The bearing 312b engages with the substrate 302 and the shaft 310b to facilitate rotational movement of the shaft 310b relative to the substrate 302. The reaction spring 320b is coupled to the shaft 310b, and oscillation of the spring 320b can cause the shaft 310b to oscillate back and forth by approximately + / - 5°, as shown by arrow 316b. Mirror 315 is coupled to axis 310b. Light source 330b is configured to project light toward mirror 314b, and the light can be reflected from mirror 315 toward detector 340b (depending on the rotational orientation of axis 310b). Therefore, movement of pin 138b is detected by an optical detection system. It should be understood that other configurations of the rotational thromboelasticity measuring assembly 300b are also contemplated within the scope of this disclosure.

[0116] The detected motion data is displayed on the analyzer console 140 (refer to Figure 1 to 140). Figure 3 The system utilizes algorithms to analyze and determine thromboelasticity measurement results. It is applicable to various thromboelasticity measurement parameters, such as, but not limited to: clotting time, clot formation time, α angle, amplitude, maximum clot hardness, dissolution initiation time, dissolution time, dissolution index (%), and maximum dissolution (%).

[0117] As the blood in cup 136b begins to coagulate, the amplitude of movement of shaft 310b begins to decrease (as detected by the deflection of the beam from mirror 315 toward detector 340b). During coagulation, the fibrin skeleton of the blood (along with platelets) forms a mechanoelastic connection between the surface of cup 136b and pin 138b. Therefore, the coagulation process induced by the addition of one or more of the aforementioned activating factors can be observed and quantified. In this way, various defects in a patient's hemostasis can be revealed and interpreted for appropriate medical intervention. At the end of the test, substrate 302 can be raised to separate shaft 310b from pin 138b.

[0118] refer to Figure 11 The main frame 144 of the analyzer console 140 may include a front section 144f and a rear section 144b. In some embodiments, the rear section 144b houses at least some computer and electronic components required for the operation of the analyzer console 140. For example, the rear section 144b may house hardware devices and software, such as, but not limited to, a computer processor, memory devices, operating system and other executable instructions, power supply, user interface controls, communication devices, circuit boards, etc.

[0119] In the depicted embodiment, the front portion 144f includes a cover 145 and a sample processor assembly 400. The sample processor assembly 400 defines an internal space that can accommodate the cartridge 120. In some embodiments, the sample processor assembly 400 is a modular sub-assembly of the analyzer console 140, and the sample processor assembly 400 can be easily removed from the analyzer console 140 for servicing. The sample processor assembly 400 is electrically interconnected with a computer and electronic components housed in the rear portion 144b. Thus, the analyzer console 140 can perform rotational thromboelasticity measurements on blood samples positioned in the cartridge 120 and display the results on a touchscreen display 142.

[0120] Now for reference Figure 11 and Figure 12 The analyzer console 140 may include a box receiver and clamp 410, as well as a viscoelastic measurement system 480. A mechanical frame assembly is used to support the box receiver and clamp 410 and the viscoelastic measurement system 480 in various orientations, so that the box receiver and clamp 410 and the viscoelastic measurement system 480 can work together.

[0121] The receiver and clamp 410, as well as portions of the viscoelasticity measurement system 480, are movable relative to the mechanical frame assembly (which is stationary relative to the analyzer control console 140). For example, the viscoelasticity measurement system 480 can move vertically. As will be further described below, the viscoelasticity measurement system 480 can move downward to engage with the cartridge 120 (e.g., refer to...). Figure 11The cassette receiver and clamp 410 are movable horizontally relative to the mechanical frame assembly. As will be further described below, a portion of the cassette receiver and clamp 410 can be moved horizontally to clamp or release the cassette 120 within the sample processor assembly 400.

[0122] In some embodiments, the cassette receiver and clamp 410 includes a movable block assembly and a fixed block assembly. A space exists between the movable block assembly and the fixed block assembly in which the cassette 120 can be accommodated. The movable block assembly can translate toward or away from the fixed block assembly. Accordingly, the cassette 120 can be clamped and released between the movable block assembly and the fixed block assembly by relative movement between them. In some embodiments, a viscoelasticity measuring system 480 is mounted to the movable block assembly. Therefore, as the movable block assembly translates, the viscoelasticity measuring system 480 also translates.

[0123] In some embodiments, the movable block assembly can be translated by a motor. In a particular embodiment, the motor is a stepper motor. In some embodiments, a gear reducer is coupled to the motor. The motor can be used to drive a lead screw by using a belt and pulley system to ensure compactness. The thread of the lead screw can engage with the complementary thread of the movable block, such that rotation of the lead screw causes horizontal translation of the movable block. In some embodiments, a stroke end detector (e.g., a proximity sensor, optical sensor, microswitch, etc.) is included to detect when the movable block assembly has horizontally translated to the desired stroke end position.

[0124] In some embodiments, one or more springs may extend between the movable block assembly and the fixed block assembly. The springs help to facilitate a suitable clamping force between the movable block assembly and the fixed block assembly. In some embodiments, the springs are adjustable.

[0125] In some embodiments, the portions of the movable block assembly and the fixed block assembly that contact the housing 120 include flexible or compressible material, such that the housing 120 is also protected from damage when it is clamped.

[0126] In certain embodiments, the movable block assembly may include one or more features on its clamping surface for positioning the cassette 120 at a desired location within the sample processor assembly 400. For example, in some embodiments, the movable block assembly includes two locating pins that can engage with locating pin recesses 140a and 140b of the cassette 120 (see reference). Figure 7 In conjunction with the sample processor assembly 400, the box 120 is precisely positioned relative to the sample processor assembly 400.

[0127] In some embodiments, one or both of the movable block assembly and the fixed block assembly include a heating device 412 that can heat the box 120 when the box is sandwiched between them. For example, in some embodiments, the heater 412 is a resistance heater for heating at least a portion of the box 120. In some embodiments, the heater 412 is configured to facilitate heating of individual portions of the box 120 independently of other portions of the box 120. For example, in some such embodiments, separate blood flow channels 130a, 130b, 130c, 130d, and 130e (see reference) Figures 4-7 One or more of the components can be heated independently. One or more sides of the box 120 can be heated. Other types of heating modes can be used, including but not limited to IR, ultrasonic, microwave, etc.

[0128] In certain embodiments, one or more temperature sensors 414 are included, which can test the temperature of the box 120 at one or more locations on the box 120. For example, in some embodiments, the one or more temperature sensors 414 may be thermocouples, thermistors, infrared temperature sensors, etc. Therefore, the analyzer control console 140 can use the heater 412 and the temperature sensors 414 to control the heating of the box 120 to a predetermined temperature (e.g., about 37°C).

[0129] The movable block assembly may include multiple solenoids for the aforementioned vent and valve of the actuation box 120. For example (see also) Figure 7 Valves 168, 170, and 160a-e can be actuated by valve actuator 430, and vent ports 166a-e can be actuated by vent port actuator 432. In some embodiments, valve actuator 430 and vent port actuator 432 include solenoids. Actuation of valves 168, 170, and 160a-e by valve actuator 430 can be achieved by connecting a pin to valve actuator 430, which can extend from the movable block subassembly to contact and expand valve elastomeric members that contact valve seats within housing 120. Actuation of vent ports 166a-e by vent port actuator 432 can be achieved by connecting a pin with a resilient tip to the movable block subassembly to block vent ports 166e-e. Such a pin with a resilient tip can serve as a stop to substantially prevent airflow through vent ports 166a-e. In some embodiments, the valve actuator 430 and the vent actuator 432 include a solenoid that includes an internal spring that allows the valve actuator 430 and the vent actuator 432 to extend normally (e.g., when power is removed from the solenoid). Therefore, by default, this normally closed solenoid will close the vent and valve of the housing 120.

[0130] The sample processor assembly 400 also includes a pressure source 436 and a vacuum source 434, through which air pressure and vacuum can be applied to the pressure application port 164 and vacuum application port 162 of the cartridge 120, respectively (see reference). Figure 7 For example, pressure source 436 and vacuum source 434 may contact cartridge 120 and, when cartridge 120 is clamped within cartridge receiver and clamp 410, may transmit pressure or vacuum to pressure application port 164 and vacuum application port 162. In some embodiments, pressure source 436 and vacuum source 434 are at least partially made of an elastic material. For example, in some embodiments, pressure source 436 and vacuum source 434 are at least partially made of an elastic material, such as, but not limited to, silicone, butyl rubber, nitrile rubber, ethylene propylene rubber, fluorinated elastomers, etc. Analyzer console 140 may also include one or more internally packaged pressure and / or vacuum pumps (not shown). Such internally packaged pressure and vacuum pumps may be used to generate air pressure or vacuum applied to cartridge 120 to induce blood transport within cartridge 120, as referenced above. Figures 8A-8H As described.

[0131] As previously described, the box receiver and fixture 410 also includes a retaining block assembly. In some embodiments, the retaining block assembly remains stationary relative to the mechanical frame assembly and overall relative to the analyzer console 140.

[0132] In some embodiments, the analyzer console 140 includes a mixing unit 440. In a particular embodiment, the mixing unit 440 includes a motor, a crank and connecting rod assembly, and a magnetic shuttle. These components can be used to magnetically couple with the mixing element of the cartridge 120 and cause movement of the mixing element within the mixing chambers 134a-e. As described above, the movement of the mixing element causes reagent beads to dissolve in the blood contained within the mixing chambers 134a-e.

[0133] The analyzer console 140 may also include one or more sensors 448. One or more sensors 448 can be used to detect the presence of blood in specific locations within the cartridge 120 (e.g., blood detection locations 127a and 127b), as described above (see reference). Figure 5 In some embodiments, sensor 448 is an optical sensor, such as an IR (infrared) sensor. In some embodiments, sensor 448 may be used to detect blood in other areas of cartridge 120, such as, but not limited to, cups 136a-e (reference). Figure 10C ).

[0134] The sample processor assembly 400 of the analyzer control console 140 also includes a viscoelasticity measurement system 480. The viscoelasticity measurement system 480 includes a substrate 302 (e.g., a reference substrate). Figure 10CThe system includes one or more thromboelasticity measurement components (e.g., thromboelasticity measurement component 300b) and a linear actuator assembly. The one or more thromboelasticity measurement components may each be fixed to the substrate 302. In some embodiments, the linear actuator assembly may be coupled to the substrate 302 and to the cassette receiver and clamp 410. Therefore, actuation of the linear actuator assembly can translate the substrate 302 toward or away from the cassette receiver and clamp 410. A linear bearing assembly of the linear actuator can guide and stabilize the substrate 302 in a straight path as it translates toward or away from the cassette receiver and clamp 410.

[0135] In some embodiments, the linear actuator assembly uses a motor (e.g., a DC motor or a stepper motor) to vertically raise or lower the substrate 302 relative to the receiver and clamp 410. The motor (e.g., a DC motor or a stepper motor) rotates a lead screw with threads that engage with a drive nut. The drive nut is coupled to the substrate 302. In some embodiments, a stroke end detector (e.g., a proximity sensor, an optical sensor, a microswitch, etc.) is included to detect when the substrate 302 has been vertically translated to the desired stroke end position.

[0136] Viscoelasticity measurement system 480 includes one or more rotational thromboelasticity measurement components (e.g., Figure 10C The rotating thromboelasticity measuring assembly 300b includes a shaft (e.g., a shaft 310b configured to couple with pin 138b) that is coupled to a pin. Since the thromboelasticity measuring assembly is mounted to a base plate 302, the shaft rises or falls as the base plate 302 is raised or lowered. Therefore, actuation of the linear actuator assembly causes the shaft to rise or fall vertically relative to the cassette receiver and clamp 410 and relative to the cassette 120 (when the cassette 120 is clamped within the cassette receiver and clamp 410). Thus, it can be understood from the description herein that actuation of the linear actuator assembly can engage and disengage the shaft from the pin of the cassette 120 (e.g., referring to…). Figure 5 It shows that the substrate 302 is lowered so that the shaft 310b engages with the pin 138B.

[0137] In addition to the aforementioned features of the analyzer console 140, in some embodiments, the analyzer console 140 also includes one or more of the following features: The analyzer console 140 may include one or more barcode scanners 450, which, for example, can read the barcode at barcode position 125 on the front end of the cartridge 120 (see reference). Figure 1AIn some embodiments, the analyzer console 140 may include one or more devices to detect the presence of the cartridge 120 in a desired insertion location and / or orientation. For example, in some embodiments, one or more microswitches may be used to detect when the cartridge 120 has been inserted into the desired location and orientation within the sample processor assembly 400. In some embodiments, the analyzer console 140 may include one or more auxiliary connectors 460. The auxiliary connectors 460 may include network and device connectors, such as, but not limited to, one or more USB ports, Ethernet ports (e.g., RJ45), VGA connectors, Sub-D9 connectors (RS232), etc. Such auxiliary connectors 460 may be located at the rear of the main chassis 144 or at other convenient locations on the main chassis 144. For example, in some embodiments, one or more USB ports may be located on or near the front of the main chassis 144.

[0138] The analyzer console 140 also includes a user interface 142 (e.g., a touchscreen display in this embodiment). In the depicted embodiment, the user interface 142 is configured to receive user input and display output information to the user. For example, a user can input information into the analyzer console 140 by selecting various soft buttons that can be displayed on the user interface 142 during the start, middle, and end of a test process. In some embodiments, other options, such as, but not limited to, soft keyboard input, can be provided via the user interface 142. In some embodiments, data input can be performed additionally or alternatively via voice input. In some embodiments, the user interface may include other peripheral devices (e.g., a mouse, keyboard, additional display device, etc.) that are part of the analyzer console 140. In some embodiments, a computer data network (e.g., an intranet, the Internet, a LAN, etc.) can be used to allow remote devices to receive and / or input information from the system 100. For example, in some embodiments, one or more remote displays can be utilized via an auxiliary connection 460. In the depicted embodiment, the user interface 142 also includes an external barcode reader 146 (see reference 140). Figures 8A-8HAlternatively or additionally, the user interface 142 of the analyzer console 140 may be equipped with a reader configured to read near-field communication tags, RFID tags, etc. The analyzer console 140 may also include one or more control systems 470 capable of executing instructions implemented in a computer program. As an example, the control system 470 may include general-purpose and special-purpose microprocessors, as well as any one or more processors of any type of digital computer. In some embodiments, the control system 470 includes one or more such processors, memories, storage devices, interfaces, and other types of electronic subsystems and components. These components may be mounted on a common motherboard or otherwise suitably mounted. The control system 470 can process instructions for execution within the analyzer console 140, including instructions stored in memory or storage devices. In some implementations, multiple processors and / or multiple buses, as well as multiple memories and various types of storage, may be used, depending on the circumstances. Furthermore, multiple computing devices may be connected, each providing a portion of the necessary operation (e.g., as a server group, a set of blade servers, or a multiprocessor system).

[0139] Storage devices can provide large-capacity storage for control system 470. In some implementations, the storage device may be or contain computer-readable media, such as floppy disk devices, hard disk devices, optical disk devices, magnetic tape devices, flash memory or other similar solid-state storage devices, or device arrays, including devices or other configurations in a storage area network. A computer program product may be tangibly implemented in an information carrier. The computer program product may also contain instructions that, when executed, perform one or more methods, as referenced above. Figure 13 As described. Computer program products can also be tangibly implemented in a computer or machine-readable medium, such as memory, storage device, or storage on processor(s).

[0140] refer to Figure 1A In some implementations, according to example procedure 490, the user can interact with the thromboelasticity measurement system provided herein. In step 492, the user inserts the analysis box into the analyzer console. In some examples, at least a portion of the box remains exposed, while the remaining portions are concealed within the analyzer console. For example, this step is referenced above. Figure 14ALet's illustrate with an example. In step 494, after receiving a prompt from the analyzer console, the user can connect the blood sample container to the cartridge. Step 494 can be performed while the cartridge remains inserted in the analyzer console as defined in step 492. In step 496, the user can press the "Start" button (or similar) to begin the automatic transport of blood from the blood sample reservoir to the blood testing chamber of the cartridge, allowing for the measurement of the blood's viscoelastic properties. In some examples, the analyzer console provides an indication that the test is ready to begin, but this process is not required as part of step 490.

[0141] refer to Figure 14B and Figure 10C In some embodiments, the thromboelasticity measurement system can perform thromboelasticity measurements according to exemplary process 500. The individual steps of process 500 may not necessarily be performed in the listed order. Furthermore, in some implementations, some steps of process 500 can be performed in parallel. Process 500 can be performed by the aforementioned thromboelasticity measurement system (such as thromboelasticity measurement system 100).

[0142] In step 510, the presence of a box is detected in the container of the analyzer console of the thromboelasticity measurement system. For example, the test can be performed using a microswitch, optical sensor, barcode scanner, or a combination thereof. Even if the box is detected in the container, at least a portion of the box may be outside the analyzer console.

[0143] In step 520, the analyzer console actuates the clamping mechanism to clamp the cassette at least partially within the analyzer console. For example, the cassette receiver and clamp 410 described above can be activated to clamp the cassette.

[0144] In step 530, the analyzer console may optionally determine whether the box has characteristics indicating that the box has been previously used. For example, the analyzer console may use an optical sensor to check for the presence of blood in the box. In some embodiments, if one or more characteristics indicating that the box has been previously used are detected, the analyzer console may pause further steps of process 500 and provide relevant messages via a user interface.

[0145] In step 540, the analyzer console can perform one or more QC tests to test the integrity of the cartridge. For example, in some embodiments, leakage of the cartridge can be tested, for example, by performing a pressure / vacuum decay test.

[0146] In step 550, the analyzer console scans the box to obtain a barcode. For example, the analyzer console can scan the front of the box, which may contain a 1D or 2D barcode.

[0147] In step 560, the analyzer console determines the type of thromboelasticity measurement test to be performed based on the information obtained from the barcode scan in step 550.

[0148] In step 570, the shaft of the thromboelasticity measurement subsystem of the analyzer console is coupled to the pins of the cartridge. These pins are positioned within the cup of the cartridge. Therefore, the coupling of the shaft and pins of the thromboelasticity measurement subsystem enables the thromboelasticity measurement system to perform thromboelasticity measurements on blood samples contained within the cup of the cartridge. For example, refer to... Figure 10C The shaft 310b of the thromboelasticity measuring component 300b can be lowered toward the housing, such that the shaft 310b becomes frictionally engaged and releasably coupled to the pin 138b of the housing 120.

[0149] In step 580, the analyzer control console can begin a reciprocating rotational motion of the cup and pin relative to the cassette. For example, this step is referenced above. Figures 8A-8H Let me give an example.

[0150] In step 590, the analyzer control console can heat the box. In some embodiments, the analyzer control console can heat the box to a predetermined temperature. In specific embodiments, the analyzer control console can maintain the box at a predetermined temperature. For example, in some embodiments, the predetermined temperature can be about 35°C to about 40°C, and preferably about 37°C.

[0151] In step 600, the analyzer console provides a prompt to connect the blood sample container to the cartridge. This prompt may be provided, for example, upon successful completion of one or more steps, or upon successful verification of one or more conditions, or both. For instance, the prompt may be provided according to step 590 when the cartridge successfully reaches a predetermined temperature. The prompt may be provided via the analyzer console's user interface. For example, the prompt may be a visual message displayed on the analyzer console's touchscreen monitor. In some implementations, an audible prompt may be provided.

[0152] In step 610, the analyzer console may optionally test for the presence of blood in the cartridge. This test may be performed, for example, using one or more IR sensors on the analyzer console. Testing for blood in the cartridge in this step may indicate that the blood sample container has been successfully coupled to the cartridge.

[0153] In step 620, the analyzer console may provide a "Start" test prompt. In some embodiments, the "Start" test prompt may be provided based on the successful completion of one or more steps, the successful verification of one or more conditions, or both. The prompt may be provided via the analyzer console's user interface. For example, the prompt may be a visual message displayed on the analyzer console's touchscreen monitor. In some embodiments, the touchscreen may receive user input to start the test.

[0154] In step 630, the analyzer console can cause blood to flow from the sample container into the cartridge. In some embodiments, a vacuum source on the analyzer console is used to cause blood to flow into the cartridge. In some embodiments, a pneumatic source on the analyzer console is used to cause blood to flow into the cartridge. The analyzer console can also actuate various valves or vents to control the flow of blood within the cartridge (e.g., see reference). Figures 8A-8H ).

[0155] In step 640, the analyzer console may induce agitation to aid in dissolving the reagent in the blood contained within the cartridge. This step is illustrated above by way of the horizontal reciprocating motion of a magnetic shuttle having one or more magnets magnetically coupled to the mixing element of cartridge 120, causing the mixing element to move within cartridge 120 to facilitate the dissolution of the reagent beads in the blood contained within mixing chambers 134a-e.

[0156] In step 650, the thromboelasticity measurement test is initiated. For example, the analyzer console can begin analyzing the coupling of pins 138a-e in the thromboelasticity measurement assembly with respect to the pins 138a-e positioned in the cups 136a-e of the cartridge (see reference). Figures 8A-8H The data is generated by the reciprocating rotation of the axis. In some embodiments, the analyzer console can begin analyzing data generated by some thromboelasticity measurement components before starting analysis of data generated by other thromboelasticity measurement components. For example, as referenced above. ​ As described, the analyzer console can first begin analyzing data about cup 136e generated by the thromboelasticity measurement component. Subsequently, the analyzer console can begin analyzing data about cup 136d generated by the thromboelasticity measurement component, and so on.

[0157] In step 660, the analyzer console displays the results of the thromboelasticity measurement. These results can be displayed during and at the completion of the test. The results can be displayed via the analyzer console's user interface, such as on a touchscreen. Qualitative graphical representations and quantitative parameters can be used to display the results.

[0158] In step 670, the analyzer console can release the box when the test is stopped. In some cases, this stop can be initiated by user input to the analyzer console, by the completion of the test assay, or by the expiration of a time-based parameter. Releasing can be performed, for example, by horizontal movement of the movable block component. After release, the box can be removed from the analyzer console.

[0159] Several embodiments of the present invention have been described. However, it should be understood that various modifications can be made without departing from the spirit and scope of the invention. Therefore, other embodiments are within the scope of the appended claims.

Claims

1. A housing for use with an analyzer control console, the housing comprising: A blood sample receiver, configured to receive a blood sample to be tested; as well as Multiple blood processing and testing pathways are arranged in parallel, each blood processing and testing pathway receives a portion of the blood sample, and each blood processing and testing pathway includes: A blood sample volume measurement chamber, which is in fluid communication with the blood sample receiver, has a selected internal volume to contain a predetermined volume of blood sample from the blood sample receiver; A mixing chamber, in fluid communication with the blood sample volume measurement chamber and containing reagents, is configured to receive a predetermined volume of liquid from the blood sample volume measurement chamber and mix the received liquid with the reagents, the mixing also occurring in a conduit upstream of the mixing chamber; and A viscoelastic blood testing chamber configured to receive a mixture of blood and reagents for performing a viscoelasticity test on the mixture while it resides in the testing chamber; and A vacuum application port, which is in fluid communication with all blood sample volume measurement chambers in the plurality of blood processing and testing paths, is configured such that blood can be drawn into the blood sample volume measurement chamber when a vacuum source is applied at the vacuum application port, wherein the vacuum application port is different from the blood sample receiver.

2. The kit of claim 1, wherein the mixing chamber comprises reagent beads that dissolve upon contact with blood from the blood sample volume measurement chamber to provide the mixed blood and reagent in the mixing chamber.

3. The kit according to claim 2, wherein the reagent beads comprise a reagent composition comprising one or more of the following: CaCl2, ellagic acid / phospholipid, tissue factor, heparinase, polybrene, cytochalasin D, or tranexamic acid.

4. The box of claim 1, wherein the blood processing and testing pathway comprises a plurality of mixing chambers arranged in series.

5. The box according to claim 4, wherein the plurality of mixing chambers includes the mixing chamber and the second mixing chamber.

6. The box of claim 1, wherein each of the blood processing and testing paths includes a stop joint between the measuring chamber and the mixing chamber.

7. The box according to claim 6, wherein pressure is applied to cause blood to flow through the stop joint.

8. The box according to claim 1, further comprising: Pressure application port.

9. The box according to claim 1, further comprising: An exhaust port is provided, which is opened to allow airflow to pass through as the blood sample flows into the mixing chamber.

10. The box of claim 1, wherein the blood sample volume measurement chamber includes an inlet port located near the top of the blood sample volume measurement chamber.

11. The box of claim 1, wherein the blood sample volume measuring chamber includes an outlet port located near the bottom of the blood sample volume measuring chamber.

12. The box according to claim 1, wherein there are four blood processing and testing pathways.

13. The box according to claim 1, wherein the box is a single-use box.

14. An analyzer control console, wherein the housing of claim 1 is configured to releasably engage with the analyzer control console.

15. The analyzer control console according to claim 14, further comprising: The user interface has a touchscreen display.

16. The analyzer console of claim 14, further comprising a sensor for detecting that the cartridge has been fully inserted into the analyzer console.

17. The analyzer control console according to claim 14, further comprising: One or more sensors, which can be used to detect the presence of blood in a specific location within the box.

18. The analyzer control console of claim 14, further comprising: A viscoelasticity measurement system for performing viscoelasticity tests on the mixed blood and reagents in the viscoelastic blood testing chamber.

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