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Publication Number
US-11054396-B2
Publication Date
2021-07-06
Expiration Date
Abstract
Provided are devices, systems and methods for the use of a portable unit for the evaluation of hemostasis. For example, a portable system for determining a plurality of hemostatic parameters may be included. The system includes a blood sample receptacle, an analyzer and a housing. The blood sample receptacle is configured to hold at least one blood sample. The analyzer is configured to determine at least two hemostatic parameters of the at least one blood sample. The housing is configured to operably couple the blood sample receptacle and the analyzer. The housing is portable and may, for example, have a thickness of 17.5 cm or smaller.
Core Innovation
The invention provides a system for determining a plurality of hemostatic parameters for a blood sample using a system housing and a receptacle configured to retain a single use cartridge. The cartridge includes wells defining a first test chamber, a second test chamber, and a third test chamber, with corresponding first, second, and third test channels, and a fluid pathway with an inlet for receiving a test sample and delivering the test sample into the wells and test chambers to interrogate viscoelastic properties of the blood sample based on induced displacement.
The system includes all reagents needed for evaluating indices of hemostasis to assess main components of hemostasis comprising plasma coagulation factors, platelets contribution, and fibrinogen contribution to coagulation. A first set of lyophilized reagents disposed along a space of the first test channel is configured to activate coagulation via the extrinsic pathway, a second set of lyophilized reagents disposed along a space of the second test channel includes a reagent configured to activate coagulation and a reagent configured to inhibit platelet function, and a third set of lyophilized reagents disposed along a space of the third test channel is configured to activate coagulation via the intrinsic pathway.
The system uses a pump-mechanism configured to fill the first, second, and third test chambers by generating pressure that moves the one or more blood samples through the cartridge channels when the cartridge is placed in the receptacle. A piezo-actuated device coupled to the receptacle within the system housing induces vibration of the blood samples in the wells to measure changes in viscoelastic properties over time.
An analyzer receives signals associated with the blood samples and determines at least two hemostatic parameters, including parameters associated with platelet contribution and fibrinogen contribution determined from assessed clot stiffness, and a plasma coagulation-factor parameter determined from an assessed clot time, and then presents the determined parameters on a display connected to the analyzer for quantifying hemostatic dysfunction and directing appropriate treatment.
Claims Coverage
The independent claim identifies one system-level approach that combines a single-use multi-chamber cartridge with pre-loaded lyophilized reagent sets, pump-driven filling, and piezo-actuated interrogation of blood viscoelastic properties over time. It determines at least two hemostatic parameters by using assessed clot time and assessed clot stiffness, and then presents the parameters for quantifying hemostatic dysfunction and directing appropriate treatment.
Single-use cartridge with three test chambers coupled to channels and fluid pathway
A receptacle configured to retain a single use cartridge, where the cartridge has wells defining a first test chamber, a second test chamber, and a third test chamber coupled to a respective first test channel, second test channel, and third test channel, and includes a fluid pathway with an inlet to receive a test sample and deliver the test sample to the first, second, and third test chambers.
Pre-loaded lyophilized reagent sets for extrinsic, platelet-inhibited, and intrinsic activation
A first set of one or more lyophilized reagents disposed along a space of the first test channel configured to activate coagulation via the extrinsic pathway; a second set of one or more lyophilized reagents disposed along a space of the second test channel including a reagent configured to activate coagulation and a reagent configured to inhibit platelet function; and a third set of one or more lyophilized reagents disposed along a space of the third test channel configured to activate coagulation via the intrinsic pathway.
Pump-mechanism filling of multiple test chambers via pressure-generated blood movement through channels
A pump-mechanism configured to fill the first test chamber, the second test chamber, and the third test chamber by generating a pressure that causes the one or more blood samples to move through channels of the cartridge to the first, second, and third test chambers.
Piezo-actuated device inducing vibration to measure viscoelastic changes over time
A piezo-actuated device coupled to the receptacle within the system housing, configured to induce vibration of the one or more blood samples in the wells to measure changes in viscoelastic properties of the blood samples over time.
Analyzer deriving hemostatic parameters from clot time and clot stiffness
An analyzer configured to determine, based on the measured viscoelastic properties, at least two hemostatic parameters including parameters selected from plasma coagulation factors, platelets contribution, and fibrinogen contribution, where platelet contribution and fibrinogen contribution are respectively determined from an assessed clot stiffness associated with a clot formed in at least one of the test chambers, and the plasma coagulation factor parameter is determined from an assessed clot time for a clot formed in one or more of the test chambers.
Graphical user interface presenting parameters for quantifying hemostatic dysfunction and directing appropriate treatment
A display contained within the system housing connected to the analyzer to present on a graphical user interface the determined parameters, including the parameters associated with the plasma coagulation factors, platelets contribution, and fibrinogen contribution, used to quantify hemostatic dysfunction and direct appropriate treatment.
Across the independent claim, the inventive concept is the combination of a single-use multi-chamber cartridge with pre-loaded lyophilized reagent sets for extrinsic and intrinsic pathway activation, with a platelet-inhibiting second set, pump-driven filling, piezo-actuated vibration-based interrogation of blood viscoelastic properties over time, and deriving plasma coagulation-factor-related parameters from assessed clot time while deriving platelet contribution and fibrinogen contribution from assessed clot stiffness, followed by display of results for quantifying hemostatic dysfunction and directing appropriate treatment.
Stated Advantages
Quantify hemostatic dysfunction and direct appropriate treatment based on displayed plasma coagulation factors, platelets contribution, and fibrinogen contribution.
Documented Applications
No documented applications found
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