Coagulation test device, system, and method of use
Inventors
Goldstein, Sheldon • Kagan, Michael • LAUDER, Nicholas • Cosman, Maury D.
Assignees
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Publication Number
US-11360074-B2
Publication Date
2022-06-14
Expiration Date
Abstract
A coagulation test device for measuring clotting time and clot characteristics of a whole blood sample under different hemostatic conditions. Results of the test are used as an aid in management of patients with coagulopathy of unknown etiology in order to help the physician determine appropriate clinical action to arrest bleeding in a patient.
Core Innovation
The invention relates to an in-vitro point-of-care coagulation testing device/system that measures clotting time and clot characteristics of whole blood. The system includes a cartridge with a test chamber and a reagent chamber in fluid communication, where the cartridge is configured to receive a whole blood sample. The cartridge further includes a metal sphere in the test chamber, and the system is configured to move a portion of the whole blood sample into the test chamber after passing through the reagent chamber.
A sensor positioned adjacent to the test chamber detects whether the metal sphere is moving in the test chamber while the cartridge is being moved. Based on whether the sensor detects movement of the metal sphere, the controller determines whether the whole blood sample in the test chamber exhibits coagulopathy. The controller outputs an indicator whether coagulopathy is present on a display, and the output is based on the sensor-detected movement of the metal sphere.
In the described embodiments, movement of the metal sphere is detected using a magnetic-field disturbance approach, including sensor arrangements with a magnet and a Hall-effect sensor to infer sphere travel time/peaks and thus viscosity progression and clot formation time. The system applies signal-pattern rules during agitation cycles to characterize clot formation and clot integrity, including determinations such as the absence of two sensor peaks and persistence of a one-sensor signal.
Claims Coverage
The document provides two independent claim scopes. Both independent claims center on a cartridge carrying a metal sphere in a test chamber, a sensor adjacent to the test chamber, and a controller that moves the cartridge while detecting metal-sphere movement to determine coagulopathy.
Cartridge with test chamber, reagent chamber, and metal sphere for whole blood
A cartridge including a test chamber, a reagent chamber in fluid communication with the test chamber, and a metal sphere in the test chamber, the cartridge configured to receive a whole blood sample.
Sensor adjacent to test chamber and controller detecting metal-sphere movement
A device configured to receive the cartridge, including a sensor positioned adjacent to the test chamber and a controller configured to move a portion of the whole blood sample into the test chamber after passing through the reagent chamber, move the cartridge, detect whether the metal sphere is moving in the test chamber, determine whether the whole blood sample exhibits coagulopathy based on the sensor, and output an indicator whether coagulopathy is present on a display.
Moving cartridge while determining coagulation from metal-sphere movement
A cartridge including a test chamber, a reagent chamber in fluid communication with the test chamber, and a metal sphere in the test chamber; a sensor positioned adjacent to the test chamber; and a controller configured to move the cartridge, determine whether the metal sphere is moving in the test chamber, determine whether the whole blood sample coagulates based on whether the sensor detects movement of the metal sphere, and output, on a display, an indicator whether coagulopathy is present based on a quality of coagulation of the whole blood sample.
Across the independent claims, the core inventive coverage is the combination of a cartridge with a test chamber and reagent chamber containing a metal sphere, a sensor adjacent to the test chamber, and controller-driven determination of coagulopathy and indicator output based on whether the sensor detects movement of the metal sphere while the cartridge is moved.
Stated Advantages
Outputs an indicator whether coagulopathy is present in the whole blood sample on a display.
Determines whether whole blood sample exhibits coagulopathy based on sensor detection of whether the metal sphere is moving in the test chamber.
Outputs an indicator whether coagulopathy is present based on a quality of coagulation of the whole blood sample.
Documented Applications
In-vitro point-of-care coagulation testing of whole blood, including rapid measurement of clotting time and clot characteristics and generation of channel-level indicators and a physician-facing diagnosis/etiology of coagulopathy on a display [procedural detail omitted for safety].
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