Portable sample analyzer cartridge

• US 8,540,946 B2
• Filed: 08/29/2011
• Issued: 09/24/2013
• 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
• Primary Examiner(s): Jarrett, Lore
• Application Number:
  US13/220,449
• Publication Number:
  US 20120003730A1
• Time in Patent Office: 757 Days
• Field of Search: 422/502
• US Class Current: 422/502
• 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 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, the lysing on the fly channel having a first intersection region that receives a first reagent from the first one of the reagent storage reservoirs and at least part of the blood sample;

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;

wherein the first intersection region includes a first end and a second end and wherein a cross-sectional area of the first intersection region tapers from the first end to the second end, the first reagent fluidly connected to the first end of the first intersection region and the at least part of the blood sample entering the first intersection region downstream of the first end such that the first reagent flows circumferentially around the blood sample.

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 flow sensors for measuring a flow rate within at least selected ones of the lysing on the fly channel, sphering on the fly channel, first flow cytometry analysis channel, or second flow cytometry analysis channel.

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 lysing on the fly channel, sphering on the fly channel, first flow cytometry analysis channel, or second flow cytometry analysis channel.

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 lysing on the fly channel, sphering on the fly channel, first flow cytometry analysis channel, or second flow cytometry analysis channel has a viscosity that is outside of a predetermined threshold.

6. The disposable analysis cartridge of claim 1, further comprising one or more additional reagent storage reservoirs, each of the one or more additional reagent storage each store a reagent selected from the group of:

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

7. The disposable analysis cartridge of claim 6 wherein the reagent is in a liquid form.

8. The disposable analysis cartridge of claim 6 wherein the reagent is in a lyophilized form.

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

10. The disposable analysis cartridge of claim 9 wherein the whole blood acquisition device includes a lancet.

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

12. The disposable analysis cartridge of claim 11 wherein at least part of the on-board whole blood storage loop is coated with an anticoagulant.

13. The disposable analysis cartridge of claim 12 wherein the anticoagulant is an ethylenediaminetetraacetic acid (EDTA).

14. The disposable analysis cartridge of claim 1 wherein 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 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.

15. The disposable analysis cartridge of claim 14 wherein at least one of the one or more white blood cell parameters relate to a total white blood cell count.

16. The disposable analysis cartridge of claim 14 wherein at least one of the one or more white blood cell parameters relates to white blood cell differentiation.

17. The disposable analysis cartridge of claim 14 wherein at least one of the one or more white blood cell parameters relates to cell volume.

18. The disposable analysis cartridge of claim 14 wherein at least one of the one or more red blood cell parameters relate to a red blood cell count.

19. The disposable analysis cartridge of claim 14 wherein at least one of the one or more red blood cell parameters relates to a platelet count.

20. The disposable analysis cartridge of claim 14 wherein at least one of the one or more red blood cell parameters relates to a cell diameter.

21. The disposable analysis cartridge of claim 14 wherein at least one of the one or more red blood cell parameters relates to a hemoglobin concentration.

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

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