DEVICES, SYSTEMS AND METHODS FOR EVALUATION OF HEMOSTASIS

• US 20200132701A1
• Filed: 10/21/2019
• Published: 04/30/2020
• Est. Priority Date: 02/15/2011
• Status: Active Application

• Current Assignee: Hemosonics LLC (Stago International SAS)
• Original Assignee: Hemosonics LLC (Stago International SAS)
• Inventors: Viola, Francesco, Walker, William F., Browne, Gregory V., Magyar, Robert S., Hansen, Bjarne, Denny, Christopher G.
• Application Number:
  US16/658,863
• Publication Number:
  US 20200132701A1
• Time in Patent Office: Days
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2200/0647 Handling flowable solids, e.g. microscopic beads, cells, particles
• CPC Class Codes: B01L 2300/02 Identification, exchange or storage of information
• CPC Class Codes: B01L 2300/024 Storing results with means integrated into the container
• CPC Class Codes: B01L 2300/027 Digital display, e.g. LCD, LED
• CPC Class Codes: B01L 2300/0627 Sensor or part of a sensor is integrated
• CPC Class Codes: B01L 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0829 Multi-well plates; Microtitration plates
• CPC Class Codes: B01L 2300/0861 Configuration of multiple channels and/or chambers in a single devices
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/123 Flexible; Elastomeric
• CPC Class Codes: B01L 2300/14 Means for pressure control
• CPC Class Codes: B01L 2300/16 Surface properties and coatings
• CPC Class Codes: B01L 2300/1805 Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks
• CPC Class Codes: B01L 2400/0436 acoustic forces, e.g. surface acoustic waves [SAW]
• CPC Class Codes: B01L 2400/0439 ultrasonic vibrations, vibrating piezo elements
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/049 : vacuum
• CPC Class Codes: B01L 2400/0666 : Solenoid valves
• CPC Class Codes: B01L 3/5027 : by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502761 : specially adapted for handling suspended solids or molecules independently from the bulk fluid flow, e.g. for trapping or sorting beads, for physically stretching molecules investigating characteristics of particles G01N15/00
• CPC Class Codes: B01L 3/527 : for a plurality of reagents
• CPC Class Codes: G01N 2800/224 : Haemostasis or coagulation
• CPC Class Codes: G01N 29/024 : by measuring propagation velocity or propagation time of acoustic waves
• CPC Class Codes: G01N 29/222 : Constructional or flow details for analysing fluids optoacoustic fluid cells G01N29/2425
• CPC Class Codes: G01N 33/86 : involving blood coagulating time or factors, or their receptors
• CPC Class Codes: G01N 35/00 : Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor

Abstract

Provided are devices systems and methods for evaluation of hemostasis. In some embodiments, an apparatus is disclosed comprising a housing, a plurality of test chambers located in the housing, the plurality of test chambers including chambers configured for measurements via a system that interrogates one or more viscoelastic properties of test samples in the test chambers, wherein the one or more viscoelastic properties is used to characterize dynamics of coagulation and/or fibrinolysis.

Claims

1-73. -73. (canceled)

74. A method of using a disposable cartridge with a blood testing console, the method comprising:

receiving in a fixed volume of a disposable cartridge a blood sample to be tested, wherein the disposable cartridge includes a plurality of testing paths arranged in a parallel, each testing path comprising a channel and a test chamber, including a first channel, a second channel, a first test chamber, and a second test chamber;

allowing a first portion of the blood sample to mix with a first reagent or combination of reagents to produce a first test sample;

allowing a second portion of the blood sample to mix with a second reagent or combination of reagents to form a second test sample;

initiating displacement within the first test sample;

interrogating the first test sample in the first test chamber to measure a first change in mechanical properties of the first test sample;

determining, by a processor, a first curve associated with stiffness of the first test sample as a function of time;

determining at least one parameter including a first parameter selected from the group consisting of clot time, clot stiffness, clot formation rate, and lysis time from the first curve;

initiating displacement within the second test sample;

interrogating the second test sample in the second test chamber to measure a second change in mechanical properties of the second test sample;

determining, by the processor, a second curve associated with stiffness of the first test sample as a function of time; and

determining at least one parameter including a second parameter selected from the group consisting of clot time, clot stiffness, clot formation rate, and lysis time from the second curve;

wherein said first parameter, said second parameter, or a combination thereof provides an indication of a state of hemostasis in the subject; and

wherein the interrogation to determine the first parameter, the second parameter, or a combination thereof is based on a viscoelastic measurement of the blood sample.