Disposable system for analysis of hemostatic function
Inventors
Viola, Francesco • Higgins, Timothy • Homyk, Andrew • Corey, F. Scott • Regan, IV, Franklin F. • Walker, William F. • Bryant, David • Givens, Thomas • Lloyd, Cynthia Ann
Assignees
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Publication Number
US-12117436-B2
Publication Date
2024-10-15
Expiration Date
Abstract
A disposable system, in some embodiments, includes a multi-channel or multi-chamber test cartridge device configured to operate with a testing system for evaluation of hemostasis in a subject by in vitro evaluation of a test sample from the subject. The disposable system, in some embodiments, is configured to interrogate the test sample to evaluate clot stiffness, strength, or other mechanical properties of the test sample to assess the function of various physiological processes occur during coagulation and/or dissolution of the resulting clot.
Core Innovation
The invention relates to an apparatus with a single-use, multi-channel test cartridge and an associated measurement system for point-of-care in vitro evaluation of hemostasis. The apparatus includes a housing with an input port configured to receive contents of a sample holding tube, and a first chamber in fluidic communication with the input port functions as a heating chamber to condition the received sample to, or near, a desired temperature before the sample contacts one or more reagents located downstream.
Downstream of the heating chamber, the apparatus includes two or more fluidic circuits, each comprising a respective second chamber and a respective testing chamber. The respective second chambers meter sample from the first chamber, at least a portion of the metered sample is introduced into one or more reagents in the corresponding fluidic circuit to form a mixed sample, and the testing chamber is configured for interrogation by a measurement system to determine at least one viscoelastic property of the respective mixed sample.
The fluidic circuits include parallel operation in which the second chambers are filled with respective metered samples drawn from the first chamber. The described fluidic architecture includes serpentine mixing pathways and reservoirs, physical mixing elements such as ferromagnetic beads or bars, reagent storage and mixing architecture using lyophilized reagent beads in reagent pockets, and measurement modalities defined for determining viscoelastic properties.
Claims Coverage
The document identifies one independent apparatus claim and dependent refinements. The independent claim covers a heated sample from a holding tube that is metered into two or more downstream reagent-containing fluidic circuits, with testing chambers interrogated by a measurement system to determine viscoelastic properties, and the second chambers filled in parallel operation.
Heated sample conditioning in an upstream heating chamber before reagent contact
A first chamber in fluidic communication with the input port functions as a heating chamber to receive and retain a sample contained in the sample holding tube and to condition the received sample to, or near, a desired temperature before the received sample is allowed to contact one or more reagents located downstream.
Metering of the conditioned sample into multiple downstream reagent-containing fluidic circuits
Two or more fluidic circuits located downstream from the first chamber each comprise a respective second chamber that meters the sample from the first chamber, and at least a portion of the metered sample is introduced to one or more reagents located in a corresponding fluidic circuit to form a respective mixed sample.
Viscoelastic-property determination by interrogation of respective testing chambers
Each fluidic circuit includes a respective testing chamber in fluidic communication with the respective second chamber, the respective testing chamber being structurally configured for interrogation by a measurement system configured to determine at least one viscoelastic property of the respective mixed sample.
Parallel filling of metered samples from a heating chamber into two or more fluidic circuits
Each of the second chambers is configured to be filled with respective metered samples drawn from the first chamber in parallel operation.
Serpentine-shaped conduit with a serpentine reservoir for mixing in each fluidic circuit
Each fluidic circuit comprises a serpentine-shaped conduit that forms a serpentine reservoir between a second chamber and a test chamber, directing portions of a metered sample through the conduit to mix the metered sample with one or more reagents.
Ferromagnetic beads or bars mixing zone in the fluidic circuit
Each fluidic circuit includes a mixing zone with ferromagnetic beads or bars between the testing chamber and the second chamber.
Ultrasonic interrogation using a lens to direct pulses into the testing chamber
A testing chamber includes a lens that directs ultrasonic pulses generated by the measurement system into the chamber.
Reagent selection constrained to specified activators, inhibitors, and biochemical components
One or more reagents in the fluidic circuits are selected from specified activators, inhibitors, and other listed biochemical components including intrinsic pathway activators, extrinsic pathway activators, coagulation activators, platelet activators, platelet inhibitors, fibrinolytic function inhibitors, thrombomodulin, polybrene, heparin, corn trypsin inhibitor, adenosine, calcium, and heparinase I.
Measurement system selection from enumerated modality families
The measurement system is chosen from sonorheometry-based, thromboelastography-based, thromboelastometry-based, optical-based, fluorescence-based, colorimetric-based, aggregometry-based, resonance-based, or electrical impedance-based systems.
Across the independent apparatus claim and its dependent refinements, the inventive coverage focuses on a heating chamber conditioning the sample, downstream fluidic circuits with metering into reagent-containing circuits, interrogation of testing chambers to determine viscoelastic properties, and parallel filling of second chambers, with dependent claims further specifying serpentine mixing structures, physical ferromagnetic mixing elements, lens-directed ultrasonic interrogation, constrained reagent component selections, and enumerated measurement-system modalities.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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