Multi-channel device for calculating coagulation characteristics of a patient's liquid test sample and methods of use related thereto

Patent metadata

Field	Value
Publication number	US-12247989-B2
Application number	US-201917279890-A
Country	US
Kind code	B2
Filing date	Sep 23, 2019
Priority date	Sep 27, 2018
Publication date	Mar 11, 2025
Grant date	Mar 11, 2025

Abstract

Devices and methods for calculating various coagulation characteristics associated with a patients liquid test sample. The presently disclosed and claimed inventive concept(s) relate to an improved device(s) and method(s) for conducting coagulation assays on a patients liquid test sample, including, without limitation, a patients whole blood sample.

First claim

What is claimed is:

1. A coagulation device for the conductance of coagulation assays on a patient's liquid test sample to determine a plurality of coagulation characteristics associated with intrinsic and extrinsic pathways of coagulation, the coagulation device comprising:
a top section, the top section comprising at least one side, a top portion, a bottom portion, and a sample receptacle;
a bottom section, the bottom section comprising at least one side, a top portion, and a bottom portion;
a center section, the center section comprising at least one side, a top portion, and a bottom portion, the center section being disposed between the top section and the bottom section, the center section further comprising at least two channels, wherein each of the at least two channels comprises an opening in fluid communication with the sample receptacle for receiving a patient's liquid test sample, further wherein each of the at least two channels is open to the top portion of the bottom section and each of the at least two channels comprises a sample window containing at least one coagulation assay reagent for conducting at least one coagulation assay in each of the at least two channels, the center section further comprising at least one spacer that completely separates each of the at least two channels from one another such that the at least two channels never cross, thereby preventing cross-contamination between the at least two channels; and
wherein the at least one coagulation assay is measured by optical interrogation at a specific wavelength by an optical source, wherein the specific wavelength is in a range of from about 750 nanometers to about 1,000 nanometers.

2. The coagulation device of claim 1 , wherein the patient's liquid test sample is selected from the group consisting of whole blood, plasma, and combinations thereof.

3. The coagulation device of claim 2 , wherein the patient's liquid test sample comprises a volume of about 15 microliters.

4. The coagulation device of claim 1 , wherein the top section, bottom section, and center section are constructed of materials selected from the group consisting of acrylic, polystyrene, styrene-acrylonitrile, polycarbonate, polyethylene terephthalate, and combinations thereof.

5. The coagulation device of claim 1 , wherein each of the at least two channels further comprises a vent.

6. The coagulation device of claim 1 , wherein the top portion of the bottom section comprises the at least one coagulation assay reagent.

7. The coagulation device of claim 1 , wherein the at least one coagulation assay reagent is selected from the group consisting of thromboplastin, celite, silica, glass, kaolin, ellagic acid, kininogen, prekallikrein, fabric, synthetic plastic, and combination thereof.

8. The coagulation device of claim 1 , wherein the optical source is selected from the group consisting of a spectrophotometer, fluorometer, and nephelometer.

9. The coagulation device of claim 1 , wherein the specific wavelength is in a range of from 750 nanometers to 850 nanometers.

10. A method for measuring the coagulation characteristics associated with a patient's liquid test sample, the method comprising the steps of:
obtaining a patient's liquid test sample;
introducing the patient's liquid test sample into a coagulation device, the coagulation device comprising:
a top section, the top section comprising at least one side, a top portion, a bottom portion, and a sample receptacle;
a bottom section, the bottom section comprising at least one side, a top portion, and a bottom portion;
a center section, the center section comprising at least one side, a top portion, and a bottom portion, the center section being disposed between the top section and the bottom section, the center section further comprising at least two channels, wherein each of the at least two channels comprises an opening in fluid communication with the sample receptacle a that receives a patient's liquid test sample upon introduction into the coagulation device, further wherein each of the at least two channels is open to the top portion of the bottom section and each of the at least two channels comprises a sample window containing at least one coagulation assay reagent for conducting at least one coagulation assay in each of the at least two channels, the center section further comprising at least one spacer that completely separates each of the at least two channels from one another such that the at least two channels never cross, thereby preventing cross-contamination between the at least two channels;

reacting the patient's liquid test sample with the at least one coagulation assay reagent within each sample window of each of the at least two channels to thereby form a reacted sample;
interrogating the reacted sample within each optical window of the at least two channels with a specific wavelength of light emitted from an optical source, the interrogation occurring over a particular duration of time at predetermined intervals;
measuring the reacted sample to determine a plurality of coagulation characteristics associated with the reacted sample.

11. The method of claim 10 , wherein the patient's liquid test sample is selected from the group consisting of whole blood, plasma, and combinations thereof.

12. The method of claim 11 , wherein the patient's liquid test sample comprises a volume of about 15 microliters.

13. The method of claim 10 , wherein the top section, bottom section, and center section of the coagulation device are constructed of materials selected from the group consisting of acrylic, polystyrene, styrene-acrylonitrile, polycarbonate, polyethylene terephthalate, and combinations thereof.

14. The method of claim 10 , wherein each of the at least two channels of the center section further comprises a vent.

15. The method of claim 10 , wherein the top portion of the bottom section comprises the at least one coagulation assay reagent.

16. The method of claim 10 , wherein the at least one coagulation assay reagent is selected from the group consisting of thrombopastin, celite, silica, glass, kaolin, ellagic acid, kininogen, prekallikrein, fabric, synthetic plastic, and combination thereof.

17. The method of claim 10 , the optical source is selected from the group consisting of a spectrophotometer, fluorometer, and nephelometer.

18. The method of claim 17 , the specific wavelength is selected from a range of wavelengths selected from the group consisting of 750 nanometers to 850 nanometers.

19. The method of claim 10 , wherein the plurality of coagulation characteristics associated with the reacted sample is selected from the group consisting of PT, PTT, aPTT, and combinations thereof.

Assignees

• Siemens Healthcare Diagnostics Inc

Inventors

• Kauffmann Aaron

Classifications

• G01N2021/0346

  Capillary cells; Microcells · CPC title

• G01N2021/0325

  Cells for testing reactions, e.g. containing reagents · CPC title

• G01N21/75

  Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated (systems in which material is burnt in a flame or plasma G01N21/72, G01N21/73) · CPC title

• G01N21/272

  for following a reaction, e.g. for determining photometrically a reaction rate (photometric cinetic analysis) · CPC title

• G01N21/03 Primary

  Cuvette constructions · CPC title