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-12019064-B2
Publication Date
2024-06-25
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 provides a device for processing a cartridge containing a whole blood sample. The cartridge includes a plurality of channels, a plurality of reagent chambers, a plurality of test chambers, and a plurality of spherical members, and a vacuum source is removably coupled to the cartridge and is activated by a controller to move the whole blood sample through the cartridge so that each channel is in fluid communication with a reagent chamber where the blood mixes with a reagent and then in fluid communication with a test chamber.
The controller agitate the cartridge and receives signals from a plurality of sensors while agitating the cartridge. Each sensor is coupled to the device and associated with one of the plurality of test chambers, and the signals are based on a presence of one of the plurality of spherical members in a test chamber within a magnetic field generated by a magnet positioned adjacent to each of the plurality of test chambers.
Based on the signal received from the sensors, the controller outputs an indicator whether coagulopathy is present in the whole blood for each of the plurality of test chambers on a display. In another embodiment, the device includes a surface configured to receive the cartridge, uses a vacuum source to move blood from a container in the cartridge into a reagent chamber and then into a test chamber, outputs the indicator based on detection of a spherical object in the test chamber while the cartridge is agitated, and remains free from contact with the whole blood sample.
Claims Coverage
The document includes two independent claims, each directed to a coagulopathy-processing device that outputs an indicator for coagulopathy presence using sensor-detected spherical member/object behavior in agitated test chambers while whole blood is moved by a vacuum through reagent and test chambers. The independent claims differ mainly by structural detail and by the requirement that the device remains free from contact with the whole blood sample in the second independent claim.
Vacuum-driven movement through reagent and test chambers for whole blood
A vacuum source is removably coupled to the cartridge and is activated to move a whole blood sample through the plurality of channels into reagent chambers where blood mixes with a reagent and then into test chambers.
Magnetic-field sensor detection of spherical members in test chambers during agitation
The controller agitate the cartridge and receive signals from sensors associated with each test chamber, where each signal is based on a presence of a spherical member in a test chamber within a magnetic field generated by a magnet positioned adjacent to each test chamber.
Indicator output for coagulopathy on a display based on sensor signals
The controller outputs an indicator whether coagulopathy is present in the whole blood for each test chamber on a display, where the indicator for each test chamber is based on the signal received from the associated sensor.
Free-from-contact coagulopathy indicator based on spherical object detection while agitating
The device comprises a surface configured to receive the cartridge and a vacuum source removably coupled to the cartridge, and the controller activates the vacuum to move whole blood from a container in the cartridge into a reagent chamber and then into a test chamber, outputs an indicator whether coagulopathy is present for the test chamber on a display based on detection of a spherical object in the test chamber while the cartridge is agitated, and remains free from contact with the whole blood sample.
Across the independent claims, the inventive coverage centers on vacuum-driven movement of whole blood through reagent and test chambers, sensor signals based on magnetic-field detection of spherical members or objects in test chambers during agitation, and controller output of a coagulopathy indicator for each test chamber on a display, with the second independent claim additionally requiring that the device remains free from contact with the whole blood sample.
Stated Advantages
Documented Applications
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