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-10429377-B1
Publication Date
2019-10-01
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 an in-vitro point-of-care coagulation testing device/system for whole blood that rapidly measures clotting time and clot characteristics under multiple hemostatic conditions. A cartridge includes isolated test chambers containing a magnetic metal sphere, where whole blood is delivered into reagent chambers and serpentine mixing/test channels. A controller controls vacuum-loaded blood movement into the test chambers and activates agitation to drive the test process.
The system determines clot formation timing and progression by non-contact magnetic sensing using a magnet and Hall-effect sensors positioned adjacent to each test chamber. Signals from the sensors are received while the cartridge is moved, and sphere travel time is detected to infer viscosity progression and clot formation timing. Clot integrity is determined from sensor signal behavior, where both sensor signals ceasing indicates higher integrity and only one continuing indicates weaker integrity, with quantified decision thresholds described.
The device compares channel results to reference/untreated channels using clotting time ratios and flags hyper- or hypocoagulable states. Based on response patterns across multiple hemostatic agents, the controller determines a probable coagulopathy etiology/diagnosis. Optional fibrinolysis monitoring is included, and the device supports barcode-based sample/cartridge identification with a display output.
Claims Coverage
The independent claim covers one core inventive concept in a system that loads whole blood into cartridge test chambers under vacuum, monitors movement of a metal sphere in each chamber using adjacent sensors while the cartridge is moving, determines whether coagulopathy is present in the whole blood for each test chamber, and outputs an indicator on a display. The dependent refinements add specific ways of determining clot formation and integrity from sensor signals, specify sensor construction, and constrain cartridge fluid handling and heating/incubation parameters.
Vacuum-loaded cartridge test chambers with metal spheres
A cartridge comprising a whole blood sample, including a plurality of test chambers and a metal sphere in each test chamber.
Vacuum move into chambers and sensor monitoring while moving
A controller configured to activate a vacuum source to move a portion of the whole blood sample into each of the test chambers, move the cartridge, and receive signals from each of the sensors while the cartridge is moving.
Non-contact determination of sphere movement in each chamber
Determine whether the metal sphere is moving in the test chamber based on the sensor signals.
Coagulopathy determination per test chamber with display output
Determine whether the whole blood sample in each test chamber exhibits coagulopathy, and output an indicator whether coagulopathy is present in the whole blood for each test chamber on a display.
Clot formation duration from sensor-detected sphere movement
The length of time for clot formation is determined based on how long a sensor in a test chamber detects movement of the metal sphere.
Clot formation detection by absence of two peaks
Clot formation is determined when the controller detects the absence of two peaks in each agitation cycle, indicating the metal sphere has stopped moving within the test chamber.
Magnet and Hall-effect sensor configuration
Each sensor includes a magnet and a Hall-effect sensor.
Vacuum port coupling with hydrophobic filters
The system includes a plurality of vacuum ports in the cartridge selectively coupled to the vacuum source and a plurality of hydrophobic filters in line with each vacuum port.
Whole blood heating within a defined temperature range
The heating element heats the whole blood sample to a temperature between 34 degrees Celsius and 37 degrees Celsius.
Overall claim coverage centers on a point-of-care coagulation system that uses a vacuum-loaded cartridge with test chambers containing a metal sphere, while sensors adjacent to the chambers detect sphere movement during cartridge movement to determine coagulopathy per chamber and display an indicator. Dependent features further define clot formation and integrity detection using sensor signal patterns, specify magnet plus Hall-effect sensors, and constrain cartridge fluid handling and heating temperature.
Stated Advantages
Rapidly measures clotting time and clot characteristics of whole blood under multiple hemostatic conditions.
Provides an indicator whether coagulopathy is present in the whole blood for each test chamber on a display.
Documented Applications
In-vitro point-of-care coagulation testing of whole blood to determine whether coagulopathy is present per test chamber and to support identification of probable coagulopathy etiology/diagnosis based on responses to multiple hemostatic agents.
Optional fibrinolysis monitoring.
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