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-10705072-B1
Publication Date
2020-07-07
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 determines clotting characteristics of a whole blood sample using an in-vitro point-of-care coagulation device/system in a cartridge that includes a plurality of test channels. Each test channel includes a reagent chamber, a test chamber, and a metal sphere in each test chamber. A portion of the whole blood sample is moved into the reagent chamber, mixed with a reagent, and moved from the reagent chamber to the test chamber.
The cartridge is agitated to move the metal sphere in the test chamber while two sensors positioned adjacent to the test chamber detect movement as the metal sphere passes the two sensors. With a controller, one or more clot characteristics are determined based on the detection of movement of the metal sphere in the test chamber, and an indicator of the one or more clot characteristics is generated for display to a user.
The system supports deriving clot characteristics from sensor signals and detecting clotting-related changes during the agitated motion of the metal sphere. The cartridge configuration enables use across multiple test channels, and the controller uses sensor-derived results to determine clot characteristics, clot integrity, clot formation timing, and viscosity based on sensor signal comparisons and movement patterns.
Claims Coverage
The document provides one independent method claim. The independent claim includes inventive features that integrate a multi-channel cartridge with reagent and test chambers containing a metal sphere, agitation with two adjacent sensors for movement detection, and controller-based determination of clot characteristics and generation of a display indicator.
Multi-channel cartridge for clot characterization
introducing the whole blood sample into a cartridge having a plurality of test channels, wherein each test channel includes a reagent chamber, a test chamber, and a metal sphere in each test chamber
Agitation-driven metal sphere movement with dual adjacent sensors
agitating the cartridge to move the metal sphere in the test chamber of the at least one test channel, while the cartridge is agitated, detecting movement of the metal sphere in the test chamber of the at least one test channel using two sensors positioned adjacent to the test chamber
Controller-derived clot characteristics from sensor passage
determining, with a controller, one or more clot characteristics of the portion of the whole blood sample based on detection of movement of the metal sphere in the test chamber of the at least one test channel as the metal sphere passes the two sensors
Display indicator for clot characteristics
generating an indicator of the one or more clot characteristics for display to a user
Overall, the claim coverage centers on using an agitated cartridge with a metal sphere whose movement through a test chamber is detected by two adjacent sensors, followed by controller-based determination of clot characteristics and generation of a user display indicator.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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