PORTABLE SAMPLE ANALYZER CARTRIDGE

• US 20120003730A1
• Filed: 08/29/2011
• Published: 01/05/2012
• Est. Priority Date: 05/14/2004
• Status: Active Grant

• Current Assignee: Honeywell International Inc.
• Original Assignee: Honeywell International Inc.
• Inventors: Padmanabhan, Aravind, Cox, James A., Cabuz, Cleopatra
• Granted Patent: US 8,540,946 B2
• Time in Patent Office: Days
• US Class Current: 435/288.7
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2200/0636 Focussing flows, e.g. to laminate flows
• CPC Class Codes: B01L 2200/146 Employing pressure sensors
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0877 Flow chambers
• CPC Class Codes: B01L 2300/14 Means for pressure control
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 9/527 for microfluidic devices, e.g. used for lab-on-a-chip
• CPC Class Codes: G01N 15/1484 microstructural devices
• CPC Class Codes: G01N 2015/012 Red blood cells
• CPC Class Codes: G01N 2015/018 Platelets
• CPC Class Codes: G01N 2015/019 Biological contaminants; Fouling
• CPC Class Codes: G01N 2015/1413 Hydrodynamic focussing
• CPC Class Codes: G01N 2015/1486 Counting the particles
• CPC Class Codes: G01N 2035/00891 Displaying information to the operator
• CPC Class Codes: G01N 35/00722 Communications; Identification

Abstract

A sample analyzer cartridge for use at a point of care of a patient such as in a doctor'"'"'s office, in the home, or elsewhere in the field. By providing a removable and/or disposable cartridge with all of the needed reagents and/or fluids, the sample analyzer can be reliably used outside of the laboratory environment, with little or no specialized training.

Claims

1. A disposable analysis cartridge capable of performing at least part of a blood sample measurement, comprising:

two or more flow cytometry analysis channels including a first flow cytometry analysis channel and a second flow cytometry analysis channel;

the first flow cytometry analysis channel having a first intersecting region that receives at least part of the blood sample as well as a sheath fluid and hydrodynamically focuses the at least part of the blood sample into a first core stream surrounded by the sheath fluid, the first flow cytometry analysis channel further including a first optical window to support flow cytometric measurements of the first core stream;

the second flow cytometry analysis channel having a second intersecting region that receives at least part of the blood sample as well as a sheath fluid and hydrodynamically focuses the at least part of the blood sample into a second core stream surrounded by the sheath fluid, the second flow cytometry analysis channel further including a second optical window to support flow cytometric measurements of the second core stream; and

a fluid director for directing flow of the blood sample to the first and second flow cytometry analysis channels.

2. The disposable analysis cartridge of claim 1 further comprising:

one or more light absorption based measurement channels.

3. The disposable analysis cartridge of claim 1 further comprising:

one or more channels fluidly connected to the fluid director;

one or more flow sensors for measuring a flow rate within at least selected ones of the one or more channels.

4. The disposable analysis cartridge of claim 3 further comprising:

one or more pressure sensors for measuring a pressure within at least selected ones of the one or more channels.

5. The disposable analysis cartridge of claim 4 further comprising:

a controller for determining if the fluid in the at least selected ones of the one or more channels has a viscosity that is outside of a predetermined threshold.

6. The disposable analysis cartridge of claim 1 further comprising:

one or more storage reservoirs, each for storing a reagent.

7. The disposable analysis cartridge of claim 6 wherein the reagent is selected from the group of:

isotonic solutions (dilution), hypotonic solutions (lysing), sphering agents, buffering agents, lysing agents, antibodies, cytochemical stains, fluorescent stains.

8. The disposable analysis cartridge of claim 7 wherein the reagent is in a liquid form.

9. The disposable analysis cartridge of claim 7 wherein the reagent is in a lyophilized form.

10. The disposable analysis cartridge of claim 1 further comprising an on-board whole blood acquisition device.

11. The disposable analysis cartridge of claim 10 wherein the whole blood acquisition device includes a lancet.

12. The disposable analysis cartridge of claim 1 further comprising an on-board whole blood storage loop.

13. The disposable analysis cartridge of claim 12 wherein at least part of the on-board whole blood storage loop is coated with an anticoagulant.

14. The disposable analysis cartridge of claim 13 wherein the anticoagulant is an ethylenediaminetetraacetic acid (EDTA).

15. The disposable analysis cartridge of claim 1 wherein the at least part of the blood sample of the first flow cytometry analysis channel includes white blood cells, and the first flow cytometry analysis channel supports the measurement of one or more white blood cell parameters, and wherein the at least part of the blood sample of the second flow cytometry analysis channel includes red blood cells, and the second flow cytometry analysis channel supports the measurement of one or more red blood cell parameters.

16. The disposable analysis cartridge of claim 15 wherein at least one of the one or more white blood cell parameters relate to a total white blood cell count.

17. The disposable analysis cartridge of claim 15 wherein at least one of the one or more white blood cell parameters relates to white blood cell differentiation.

18. The disposable analysis cartridge of claim 15 wherein at least one of the one or more white blood cell parameters relates to cell volume.

19. The disposable analysis cartridge of claim 15 wherein at least one of the one or more red blood cell parameters relate to a red blood cell count.

20. The disposable analysis cartridge of claim 15 wherein at least one of the one or more red blood cell parameters relates to a platelet count.

21. The disposable analysis cartridge of claim 15 wherein at least one of the one or more red blood cell parameters relates to a cell diameter.

22. The disposable analysis cartridge of claim 15 wherein at least one of the one or more red blood cell parameters relates to a hemoglobin concentration.

23. The disposable analysis cartridge of claim 15 further comprising one or more storage reservoirs each for storing a reagent, wherein at least one of the reagents is mixed with the blood sample that is directed to the first flow cytometry analysis channel.

24. The disposable analysis cartridge of claim 23 wherein at least one of the reagents that is mixed with the blood sample that is directed to the first flow cytometry analysis channel is a red blood cell lysing agent.

25. The disposable analysis cartridge of claim 24, wherein at least one of the reagents is mixed with the blood sample that is directed to the second flow cytometry analysis channel.

26. The disposable analysis cartridge of claim 25 wherein at least one of the reagents that is mixed with the blood sample that is directed to the second flow cytometry analysis channel is a red blood cell sphering agent.

27. The disposable analysis cartridge of claim 1 further comprising an absorption channel that is configured to support optical absorption measurements.

28. The disposable analysis cartridge of claim I further comprising an extinction channel that is configured to support optical extinction measurements.

29. A disposable analysis cartridge capable of performing at least part of a blood sample measurement, comprising:

two or more separate flow cytometry analysis channels, each of the two or more separate flow cytometry analysis channels having means for hydrodynamically focusing a sample and means for supporting flow cytometric measurements of the focused sample; and

fluid directing means for directing flow of a blood sample to at least two of the two or more flow cytometry analysis channels.

30. A disposable analysis cartridge capable of performing at least part of a blood sample measurement, comprising:

two or more reagent storage reservoirs, a first one for storing a lysing reagent and a second one for storing a sphering reagent;

a lysing on the fly channel in fluid communication with the first one of the reagent storage reservoirs;

a sphering on the fly channel in fluid communication with the second one of the reagent storage reservoirs;

a first flow cytometry analysis channel structured to hydrodynamically focus a blood sample and to support optical light scattering measurements, the first flow cytometry analysis channel in fluid communication with and downstream of the lysing on the fly channel; and

a second flow cytometry analysis channel structured to hydrodynamically focus a blood sample and to support optical light scattering measurements, the second flow cytometry analysis channel in fluid communication with and downstream of the sphering on the fly channel.