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-10520489-B1
Publication Date
2019-12-31
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 a point-of-care in vitro coagulation testing device/system that processes a cartridge containing a whole blood sample. A vacuum source moves the whole blood sample from a container into a plurality of channels in the cartridge and subsequently into a plurality of reagent chambers where the blood mixes with a reagent, then through a plurality of serpentine-shaped channels to a plurality of test chambers.
The device activates an actuator to agitate the cartridge and receives signals from a plurality of sensors associated with the test chambers. Each sensor generates signals based on the presence of a spherical member within a magnetic field generated by a magnet positioned adjacent to each test chamber, and the system uses the sensor signals to determine whether coagulopathy is present in the whole blood for each test chamber and outputs an indicator on a display.
The system further distinguishes clot formation and clot integrity/strength using the sensor behavior associated with the spherical member. Clot formation is determined by sensor peak absence indicating that the spherical member has stopped moving within a test chamber, and clot integrity/strength is determined by whether sensor signals continue after clot formation and by signal/duty-cycle metrics.
The device computes clotting time and clotting time ratios relative to untreated/reference channels to classify coagulopathy and to flag hypercoagulable or hypocoagulable conditions, including inference of likely etiology based on response patterns to multiple hemostatic agents.
Claims Coverage
The independent claim covers an integrated cartridge-processing coagulation testing device that uses vacuum-driven channel loading, reagent mixing/incubation, actuator-based agitation, and magnetic-field sensing with a spherical member to determine and display whether coagulopathy is present in each test chamber. Dependent claims refine cartridge fluid control, heating/incubation constraints, and the sensor-peak rules used to determine clot formation and related timing/viscosity-based features.
Vacuum-driven cartridge processing with serpentine channels to reagent and test chambers
A device having a recess for receiving a cartridge, a vacuum source coupled to the cartridge, and an actuator linked to the cartridge to agitate the cartridge, where a controller activates the vacuum source to move a whole blood sample from a container into a plurality of channels in the cartridge, into a plurality of reagent chambers where the blood mixes with a reagent, and then through a plurality of serpentine-shaped channels to a plurality of test chambers.
Magnet-adjacent sensing of a spherical member in each test chamber
A device where the controller receives signals from a plurality of sensors, each sensor associated with one of the test chambers, where the signals are based on the presence of a spherical member within a magnetic field generated by a magnet positioned adjacent to each of the test chambers.
Coagulopathy determination and per-test-chamber display output
A device where the controller determines whether coagulopathy is present in the whole blood for each test chamber and outputs an indicator whether coagulopathy is present in the whole blood for each test chamber on a display.
Stop-flow fluid control using vacuum ports with hydrophobic filters
A device including multiple vacuum ports coupled to a vacuum source and multiple hydrophobic filters in line with the vacuum ports that are configured to stop the flow of blood once each reagent chamber is filled.
Heating the whole blood sample within a defined temperature range
A device including a heating element that heats a whole blood sample to a temperature between 34°C and 37°C.
Incubating a blood–reagent mixture for a defined time range
A device that mixes a whole blood sample with a reagent in each reagent chamber and incubates the mixture for between 1 minute and 10 minutes.
Clot formation detection by absence of two peaks within an agitation cycle
A device where clot formation is determined by detecting the absence of two peaks in each agitation cycle, indicating that a spherical member has stopped moving within a test chamber.
Viscosity proportional timing between two sensor peaks
A device where spherical members move past two sensors in each test chamber to generate peak signals, and where the time between the two sensor peaks is proportional to the viscosity of a whole blood sample in each test chamber.
Across the independent claim and its refinements, the core inventive coverage is a cartridge-based coagulation device that uses vacuum to move whole blood through channels into reagent and serpentine pathways to test chambers, actuates agitation, and determines coagulopathy per test chamber by magnet-field sensing of a spherical member. Dependent features refine stop-flow fluid control with hydrophobic filters, defined heating and incubation ranges, and specific sensor-peak rules for clot formation and timing/viscosity proportional features.
Stated Advantages
Outputs an indicator whether coagulopathy is present in the whole blood for each test chamber on a display.
Determines coagulopathy presence for each test chamber using sensor signals based on a spherical member in a magnetic field.
Provides a defined approach for clot formation detection based on sensor peak absence indicating stopped motion.
Relates a measurable timing feature between sensor peaks to viscosity of a whole blood sample in each test chamber.
Documented Applications
Point-of-care in vitro coagulation testing using a cartridge processed with whole blood and multiple channels under different hemostatic conditions.
Assessing coagulopathy presence in a whole blood sample per test chamber and outputting indicators on a display.
Classifying coagulopathy as hypercoagulable or hypocoagulable using clotting time and clotting time ratios versus untreated/reference channels and response patterns to multiple hemostatic agents.
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