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

• US 9,915,671 B2
• Filed: 11/21/2016
• Issued: 03/13/2018
• Est. Priority Date: 12/23/2008
• Status: Active Grant

• Current Assignee: C. A. Casyso GmbH
• Original Assignee: C A Casyso AG
• Inventors: Schubert, Axel, Romero-Galeano, Jose J., Kessler, Max
• Primary Examiner(s): WEST, PAUL M
• Application Number:
  US15/357,492
• Publication Number:
  US 20170097367A1
• Time in Patent Office: 477 Days
• Field of Search: 73 5428, 73 6441- 6443, 73 6453, 356 39, 422 73, 436 69
• 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 device for evaluation of hemostasis, comprising:

a plurality of cavities, including a first cavity, a second cavity and a third cavity, wherein each of the plurality of cavities comprises one or more reagents therein;

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,

wherein the first cavity comprises one or more reagents configured for extrinsic activation of the coagulation cascade;

wherein the second cavity comprises (i) one or more reagents configured for extrinsic activation of the coagulation cascade and (ii) one or more reagents configured for suppressing thrombocyte function; and

wherein the third cavity comprises one or more reagents configured for intrinsic activation of the coagulation cascade.

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

3. The device of claim 1, wherein the one or more reagents configured for extrinsic activation of the coagulation cascade include tissue factor.

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 1, wherein the one or more reagents configured for intrinsic activation of the coagulation cascade include a Hagemann factor.

6. The device of claim 1, wherein the plurality of cavities further comprises a fourth cavity.

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

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

9. The device of claim 8, wherein the measuring system is configured to measure over time changes in viscoelastic properties of the portion of the test sample in each of the cavities.

10. The device of claim 9, 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.

11. The device of claim 9, wherein the changes in viscoelastic properties of the portion of the test sample are measured by the measuring system detecting changes in amplitude of an oscillating motion excitation of the portion of the test sample.

12. The device of claim 11, 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.

13. The device of claim 9, wherein the measuring system is configured to measure clotting time for the portion of the test sample in each of the cavities.

14. The device of claim 9, wherein the measuring system is configured to measure clot formation time for the portion of the test sample in each of the cavities.

15. The device of claim 9, wherein the measuring system is configured to measure a maximum clot firmness for the portion of the test sample in each of the cavities.

16. The device of claim 9 wherein the measuring system includes a light beam detector.

17. The device of claim 16, wherein the light beam detector is used to detect changes in amplitude of an oscillating motion excitation of the portion of the test sample.

18. The device of claim 9, wherein the measurement system is configured to measure changes in viscoelastic properties of the portions of the test samples based on a periodic induced motion in the portions of the test sample.

19. The device of claim 18, wherein the periodic induced motion is a periodic rotational motion by a shaft.

20. A method for using the device of claim 9, the method comprising measuring over time changes in viscoelastic properties of the portion of the test sample in each of the cavities and comparing the measured changes in viscoelastic properties of the portion of the test sample in the first chamber with the measured changes in viscoelastic properties of the portion of the test sample in the second chamber.

21. The method of claim 20, further comprising assessing a fibrinogen deficiency on the basis of the comparison.

22. A method for using the device of claim 9, the method comprising measuring over time changes in viscoelastic properties of the portion of the test sample in each of the cavities and assessing a fibrinogen deficiency on the basis of such measurements.

23. A method for using the device of claim 9, the method comprising performing at least three measurements in parallel within the plurality of cavities using a combination of agonists and antagonists of different parts of the coagulation cascade.

24. The device of claim 8, wherein the measuring system includes control apparatus configured for interacting with the cartridge to move the test sample through the cartridge.

25. The device of claim 8, wherein the measuring system includes control apparatus for measurement, data analysis and user interaction.

26. The device of claim 8, wherein the measuring system is configured for receiving and securing the cartridge.

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

28. The device of claim 1, wherein each of the plurality of cavities is a measurement cavity integrally formed with a reagent cavity.

29. The device of claim 28, wherein each measurement cavity is configured for measuring viscoelastic characteristics of the portion of the test sample.

30. The device of claim 1, further comprising a housing.

31. The device of claim 30, wherein the housing defines the inlet.

32. The device of claim 30, wherein each of the plurality of cavities are at least partially defined by the housing.

33. The device of claim 30, wherein the housing includes a housing body and a cover, wherein the housing body and the cover cooperate to define and enclose the ductwork and cavities.

34. The device of claim 30, wherein the housing defines a unitary cartridge comprising the plurality of cavities and the ductwork.

35. The device of claim 34, wherein the cartridge is disposable.

36. The device of claim 1, wherein the device is configured for measuring viscoelastic characteristics of each of the portion of the test sample based on detecting changes in clot firmness.

37. The device of claim 36, wherein clot firmness is continuously determined from formation of fibrin fibres through dissolution by fibrinolysis.

38. The device of claim 1, wherein the device is configured for performing at least three measurements in parallel within the plurality of cavities using a combination of agonists and antagonists of different parts of the coagulation cascade.

39. The device of claim 1, wherein the device is configured such that the one or more reagents within each of the cavities are mixed with the portion test sample in a portion of the fluid pathway prior to being delivered to the cavities.

40. A method for using the device of claim 1, comprising mixing the one or more reagents in each of the cavities with the portion test sample in a portion of the fluid pathway prior to being delivered to the cavities.