Blood testing system and method

• US 10,288,630 B2
• Filed: 12/03/2015
• Issued: 05/14/2019
• Est. Priority Date: 09/29/2014
• Status: Active Grant

• Current Assignee: C. A. Casyso GmbH
• Original Assignee: C. A. Casyso GmbH
• Inventors: Gorin, Michael, Hillman, Robert S., McCluskey, Cory Lee, Schwaiger, Hubert Martin
• Primary Examiner(s): Siefke, Samuel P
• Application Number:
  US14/958,876
• Publication Number:
  US 20160091514A1
• Time in Patent Office: 1,258 Days
• 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: G01N 11/14 by using rotary bodies, e.g. vane G01N11/16 takes precedence
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors

Abstract

Some embodiments of a blood coagulation testing system include an analyzer console device and a single-use cartridge component configured to releasably install into the console device. In some embodiments, the blood coagulation testing system can operate as an automated thromboelastometry system that is particularly useful, for example, at a point-of-care site.

Claims

1. A cartridge device for a measuring system for measuring viscoelastic characteristics of a sample liquid, the cartridge device comprising:

a measuring chamber formed therein configured to contain a predetermined amount of the sample liquid; and

a mixing chamber formed therein and in fluid connection with the measuring chamber for receiving the predetermined amount of the sample liquid, flowed from the measuring chamber, the mixing chamber comprising;

a retaining element comprising an array of posts crossing a flow direction from the measuring chamber into the mixing chamber and coupled to a wall within the mixing chamber, the array of posts of the retaining element restricting movement of a set of reagent beads within the mixing chamber, individually separating each of the set of reagents beads from other reagent beads of the set of reagent beads, and separating the set of reagents beads from a mixing element retained within the mixing chamber.

2. The cartridge device of claim 1, wherein the sample fluid entirely submerges the set of reagent beads below a predetermined sample liquid fill level in the mixing chamber and fluidly couples the set of reagent beads and the mixing element.

3. The cartridge device of claim 1, wherein the retaining element is configured to prevent interaction of the mixing element and the reagent bead.

4. The cartridge device of claim 1, wherein the retaining element is configured to prevent interaction of the reagent bead with another reagent bead in the mixing chamber.

5. The cartridge device of claim 1, wherein the retaining element is configured to maintain the reagent bead at a predetermined vertical location in the mixing chamber.

6. The cartridge device of claim 5, wherein the predetermined vertical location is above the fill level of solution in the mixing chamber.

7. The cartridge device of claim 1, wherein the retaining element comprises a barrier.

8. The cartridge device of claim 1, wherein the retaining element comprises an inward protrusion or an outward protrusion in the wall of the mixing chamber.

9. The cartridge device of claim 1, wherein the retaining element comprises a compartment for holding at least one reagent bead.

10. The cartridge device of claim 1, wherein the mixing chamber retains a dry reagent near an exit of the sample liquid.

11. The cartridge device of claim 1, wherein the mixing chamber further comprises a reagent deposited on a wall of the mixing chamber.

12. The cartridge device of claim 10, wherein the reagent is below the fill level of the mixing chamber.

13. The cartridge device of claim 10, wherein the reagent is deposited on the wall of the mixing in the form of a dissolvable thin film.

14. The cartridge device of claim 1, wherein the sample liquid is a blood sample.

15. The cartridge device of claim 1, further comprising a first duct connecting the measuring chamber to the mixing chamber.

16. The cartridge device of claim 15, wherein the first duct comprises a reagent bead disposed therein.

17. The cartridge device of claim 15, wherein the first duct comprises a second retaining element configured to retain a reagent in the first duct.

18. The cartridge device of claim 17, wherein the second retaining element is configured to allow sample to flow through the first duct across the reagent.

19. The cartridge device of claim 1, further comprising a testing chamber comprising a probe element arranged therein, the probe element configured to perform a test on the sample liquid received from the mixing chamber.

20. The cartridge device of claim 19, wherein the testing chamber measures the viscoelastic characteristics of the sample liquid.

21. The cartridge device of claim 19, wherein the probe element is movable within the testing chamber for measuring viscoelastic characteristics of the sample liquid.

22. The cartridge device of claim 19, further comprising a second duct connecting the testing chamber to the mixing chamber, the testing chamber configured for receiving a sample liquid from the mixing chamber, the sample liquid comprising dissolved reagent.

23. The cartridge device of claim 22, further comprising a dry reagent deposited in the second duct connecting the testing chamber to the mixing chamber.

24. The cartridge device of claim 19, wherein the cartridge device is attachable to an interface element of a measuring system for measuring viscoelastic characteristics of a sample liquid, the measuring system comprising:

a shaft rotatably supported by the interface element to be rotated by drive means, the probe element of the testing chamber engageable with the shaft;

a detector engaging with the shaft for measuring viscoelastic characteristics of the sample liquid in contact with the probe element; and

a controller to control the measuring system.

25. The measuring system of claim 24, wherein the probe element is movable within the testing chamber of the cartridge device for measuring viscoelastic characteristics of the sample liquid.

26. The measuring system of claim 24, wherein the sample liquid is a blood sample.

27. A method for measuring viscoelastic characteristics of a sample liquid by the measuring system of claim 24, comprising:

providing the cartridge device having the testing chamber with the probe element arranged therein;

attaching the cartridge device to the interface element, the shaft being inserted into the probe element;

filling the testing chamber of the cartridge device with the sample liquid;

rotating the shaft in an oscillating motion around a rotation axis; and

measuring viscoelastic characteristics of the sample liquid by detecting the rotation of the shaft by the detecting means.

28. A method of mixing a sample liquid with a reagent for measuring viscoelastic characteristics of the sample liquid, comprising:

providing a cartridge device of claim 1 comprising a sample liquid in the measuring chamber; and

flowing the sample liquid to the mixing chamber, thereby contacting the sample liquid with the reagent bead that is retained in place by the retaining element and is retained such that the reagent bead is below a sample liquid fill level for the mixing chamber, wherein the sample liquid dissolves the reagent bead, the reagent in the reagent bead mixing with the sample liquid.

29. The method of claim 28, wherein the sample liquid is a blood sample.

30. The method of claim 28, further comprising using an external magnet to cause movement of the mixing element, thereby agitating the solution to facilitate dissolution of the reagent bead into the sample liquid.