Cartridge device for a measuring system for measuring viscoelastic characteristics of a sample liquid, a corresponding measuring system, and a corresponding method

• US 10,746,750 B2
• Filed: 09/28/2018
• Issued: 08/18/2020
• Est. Priority Date: 12/23/2008
• Status: Active Grant

• Current Assignee: C. A. Casyso GmbH
• Original Assignee: C. A. Casyso GmbH
• Inventors: Schubert, Axel, Romero-Galeano, Jose J., Kessler, Max
• Primary Examiner(s): West, Paul M.
• Application Number:
  US16/146,333
• Publication Number:
  US 20190195898A1
• Time in Patent Office: 690 Days
• 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 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0861 Configuration of multiple channels and/or chambers in a single devices
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/0475 specific mechanical means and fluid pressure
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/52 Containers specially adapted for storing or dispensing a reagent B01L3/02 takes precedence; containers for medical or pharmaceutical purposes A61J1/00; containers in general B65D; storing or dispensing test elements G01N33/4875; automated reagent dispensing G01N35/1002
• CPC Class Codes: G01N 11/00 Investigating flow properties of materials, e.g. viscosity, plasticity; Analysing materials by determining flow properties
• CPC Class Codes: G01N 11/14 by using rotary bodies, e.g. vane G01N11/16 takes precedence
• CPC Class Codes: G01N 2011/0046 In situ measurement during mixing process
• CPC Class Codes: G01N 2333/96458 Factor XII (3.4.21.38)
• CPC Class Codes: G01N 2800/224 Haemostasis or coagulation
• 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

The present invention is directed to a cartridge device for a measuring system for measuring viscoelastic characteristics of a sample liquid, in particular a blood sample, comprising a cartridge body having at least one measurement cavity formed therein and having at least one probe element arranged in said at least one measurement cavity for performing a test on said sample liquid; and a cover being attachable on said cartridge body; wherein said cover covers at least partially said at least one measurement cavity and forms a retaining element for retaining said probe element in a predetermined position within said at least one measurement cavity. The invention is directed to a measurement system and a method for measuring viscoelastic characteristics of a sample liquid.

Claims

1. A cartridge device for evaluation of hemostasis, comprising:

a plurality of cavities each configured to receive blood of a test sample, each cavity comprising a reagent or combination of reagents;

ductwork, including an inlet for receiving a test sample, wherein the ductwork is in communication with each of the plurality of cavities, whereby each of the plurality of cavities is configured to receive, via the ductwork, a portion of the test sample

a first cavity of the plurality of cavities comprising a first reagent or a first combination of reagents that interact with the blood received therein, wherein the first reagent, or a reagent included in the first combination of reagents, is an activator of coagulation;

a second cavity of the plurality of cavities comprising a second combination of reagents that interact with blood of the test sample received therein, the second combination including an activator of coagulation and one or more reagents configured for suppressing thrombocyte function; and

a viscoelastic interrogation device that measures blood clot firmness of the test sample or other parameters dependent on measurement of blood clot firmness.

2. The device of claim 1, wherein the activator of coagulation of the first cavity and the activator of coagulation of the second cavity are one or more reagents configured for extrinsic activation of the coagulation cascade.

3. The device of claim 2, wherein a third cavity of the plurality of cavities comprises one or more reagents configured for intrinsic activation of the coagulation cascade.

4. The device of claim 3, wherein the one or more reagents configured for suppressing thrombocyte function include cytochalasin D.

5. The device of claim 3 wherein the one or more reagents configured for intrinsic activation of the coagulation cascade include a Hagemann factor.

6. The device of claim 3, wherein a fourth cavity of the plurality of cavities comprises one or more reagents configured for testing platelet aggregometry.

7. The device of claim 2, wherein the one or more reagents configured for suppressing thrombocyte function include cytochalasin D.

8. The device of claim 1, wherein the one or more reagents configured for suppressing thrombocyte function include cytochalasin D.

9. The device of claim 1, wherein the device is a cartridge configured for use in conjunction with a measuring system.

10. The device of claim 9, wherein the measuring system is configured to measure over time changes in blood clot firmness of the portion of the test sample in each of the cavities.

11. The device of claim 10, wherein the measuring system is configured to receive the cartridge in a pre-determined orientation whereby the cartridge in the pre-determined orientation is aligned with a plurality of detectors, each of the plurality of detectors associated with a respective cavity.

12. The device of claim 10, wherein the measuring system includes control apparatus configured for interacting with the cartridge to move the test sample through the cartridge.

13. The device of claim 10, wherein the changes in the blood clot firmness of the portion of the test sample or the other parameters dependent thereon are measured by the measuring system detecting changes in amplitude of an oscillating motion excitation of the portion of the test sample.

14. The device of claim 13, wherein the oscillating motion excitation of the portion of the test sample is achieved mechanically via a plurality of probes interfaced with the measuring system.

15. The device of claim 10, wherein the device is configured for use with a single test sample.

16. The device of claim 15, further comprising a fluid pathway having an inlet for receiving a test sample, wherein the fluid pathway is in communication with at least one cavity to deliver the test sample, or a portion thereof, to one or more of the cavities.

17. The device of claim 16, wherein the fluid pathway further comprises a channel in communication with a least one cavity, and wherein sample delivered from the channel into the cavity results in mixing of at least a portion of the sample and the reagent within the cavity.

18. The device of claim 1, wherein the one or more reagents within each of the plurality of cavities are in a solid form.

19. The device of claim 1, further comprising a housing, wherein each of the plurality of cavities are at least partially defined by the housing.

20. The device of claim 1, wherein the second cavity comprises a combination of reagents that includes a reagent comprised by the first cavity.

21. The device of claim 1, wherein the interrogation device is configured to measure changing in elastic properties of the test sample.

22. The device of claim 1, wherein the device is configured to be interrogated to determine a hemostatic parameter of the test sample.

23. The device of claim 1, wherein the interrogation device is configured to perform a viscoelastic method of testing.

24. The device of claim 1, wherein the interrogation device is configured to continuously measure the blood clot firmness or the other parameters dependent thereon from the formation of the first fibrin fibers until the dissolution of the blood clot by fibrinolysis.

25. The device of claim 1, wherein the interrogation device is configured to measure a maximum clot firmness.

26. The device of claim 1, wherein the interrogation device is configured to measure a rate of clot formation.

27. The device of claim 1, wherein the interrogation device is configured measure blood clot firmness during multiple interlinked processes including coagulation activation, thrombin formation, fibrin formation and polymerization, platelet activation and fibrin-platelet interaction and fibrinolysis.

28. The device of claim 1, wherein the interrogation device is configured for thromboelastometry or thromboelastography.

29. The device of claim 1, wherein the interrogation device is configured to generate a curve representing changes in clot firmness over time.

30. The device of claim 1, wherein the ductwork defines a fluid pathway includes an inlet channel, a first channel, and a second channel, wherein the inlet channel is in communication with the inlet, wherein the first channel is in communication with the inlet channel and at least with the first cavity, and wherein the second channel is in communication with the inlet channel and at least with the second cavity.

31. The device of claim 30, wherein a pump is configured to move the sample through the fluid pathway and distribute the sample from the inlet to the plurality of cavities.