Coagulation test device, system, and method of use

• US 10,520,489 B1
• Filed: 09/12/2019
• Issued: 12/31/2019
• Est. Priority Date: 03/15/2019
• Status: Active Grant

• Current Assignee: Coagulation Sciences LLC
• Original Assignee: Coagulation Sciences LLC
• Inventors: Goldstein, Sheldon, Kagan, Michael, Lauder, Nicholas, Cosman, Maury D.
• Primary Examiner(s): Wecker, Jennifer
• Application Number:
  US16/569,148
• Time in Patent Office: 110 Days
• CPC Class Codes: B01L 2200/02 Adapting objects or devices to another
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0627 Sensor or part of a sensor is integrated
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0819 Microarrays; Biochips
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/0883 Serpentine channels
• CPC Class Codes: B01L 2400/043 magnetic forces
• CPC Class Codes: B01L 2400/049 vacuum
• 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 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/56
• CPC Class Codes: G01N 33/50 Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing measuring or testing processes involving enzymes or microorganisms, compositions or test papers therefor; processes for forming such compositions, condition responsive control in microbiological or enzymological processes C12Q
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors
• CPC Class Codes: G01R 33/072 Constructional adaptation of the sensor to specific applications

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.

Claims

1. A device for processing a cartridge containing a whole blood sample, the device comprising:

a recess for receiving the cartridge,

a vacuum source coupled to the cartridge,

an actuator linked to the cartridge to agitate the cartridge; and

a controller configured to

activate the vacuum source to move 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, and then through a plurality of serpentine-shaped channels to a plurality of test chambers,

activate the actuator to agitate the cartridge,

receive 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,

determine whether coagulopathy is present in the whole blood for each test chamber, and

output an indicator whether coagulopathy is present in the whole blood for each test chamber on a display.

2. The device of claim 1, further comprising a plurality of vacuum ports in the cartridge selectively coupled to the vacuum source, and further comprising a plurality of hydrophobic filters in line with each of the vacuum ports, the hydrophobic filters configured to stop the flow of blood when each of the reagent chambers is filled.

3. The device of claim 1, further comprising a heating element configured to apply thermal energy to the cartridge and to the whole blood sample.

4. The device of claim 3, wherein the heating element heats the whole blood sample to a temperature between 34 degrees Celsius and 37 degrees Celsius.

5. The device of claim 3, wherein the heating element heats the whole blood sample to a temperature between 30 degrees Celsius and 33 degrees Celsius.

6. The device of claim 4, wherein the whole blood sample is mixed with a reagent in each of the reagent chambers and incubated between 1 minute and 10 minutes.

7. The device of claim 6, wherein the reagents in each of the reagent chambers is isolated from its adjacent reagent chambers.

8. The device of claim 1, wherein the controller is further configured to determine a length of time to clot formation in each of the test chambers.

9. The device of claim 8, wherein the length of time is based on how long the sensor associated with one of the test chambers detects movement of the spherical member.

10. The device of claim 1, wherein each test channel includes two of the sensors.

11. The device of claim 10, wherein the controller is further configured to determine clot formation.

12. The device of claim 11, wherein clot formation is determined when the controller detects the absence of two peaks in each agitation cycle and is indicative that the spherical member has stopped moving within the test chamber.

13. The device of claim 11, wherein the controller is further configured to determine clot integrity.

14. The device of claim 13, wherein a clot of high integrity is determined where neither one of the two sensors generates a signal after the clot formation.

15. The device of claim 13, wherein a clot of low integrity is determined where one of the two sensors continues to generate a signal indicating that the clot is allowing the spherical member to move over a limited distance.

16. The device of claim 13, wherein clot integrity is based on an average signal in the test chamber generated by the two sensors from the time the clot formed to the end of the test.

17. The device of claim 16, wherein duration of the test is up to 1,800 seconds.

18. The device of claim 1, wherein the cartridge includes 18 test chambers.

19. The device of claim 18, wherein each of the 18 test chambers is associated with one of the reagent chambers, and wherein each of the 18 test chambers receives a whole blood-reagent complex from the associated reagent chamber.

20. The device of claim 10, wherein the spherical member in each test chamber passes over the two sensors associated with each test chamber to generate a peak signal for each sensor, and wherein a time between the two sensor peaks for each test chamber is proportional to the viscosity of the whole blood sample within each test chamber.

21. The device of claim 1, wherein the controller is further configured to determine a diagnosis based on results of the individual channel responses to the reagents in the associated reagent chamber.

22. The device of claim 1, wherein the controller is further configured to output the diagnosis on the display.