PORTABLE SAMPLE ANALYZER WITH REMOVABLE CARTRIDGE

• US 20050255001A1
• Filed: 05/12/2005
• Published: 11/17/2005
• Est. Priority Date: 05/14/2004
• Status: Active Grant

• Current Assignee: Honeywell International Inc.
• Original Assignee: Honeywell International Inc.
• Inventors: Padmanabhan, Aravind, Fritz, Bernard S., Cabuz, Cleopatra, Cox, James A.
• Granted Patent: US 7,641,856 B2
• Time in Patent Office: Days
• US Class Current: 422/73
• CPC Class Codes: B01L 2200/0636 Focussing flows, e.g. to laminate flows
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 3/502776 specially adapted for focusing or laminating flows
• CPC Class Codes: G01N 15/1404 Handling flow, e.g. hydrodynamic focusing
• CPC Class Codes: G01N 2015/1413 Hydrodynamic focussing
• CPC Class Codes: G01N 2015/1486 Counting the particles
• CPC Class Codes: Y10T 436/101666 Particle count or volume standard or control [e.g., platelet count standards, etc.]

Abstract

A sample analyzer with a removable and/or disposable cartridge for use at the 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 cell analysis system, comprising:

a body adapted to selectively receive a disposable fluidic cartridge, wherein the disposable fluidic cartridge includes a first flow cytometry analysis channel adapted to hydrodynamically focus a sample fluid in a first flow channel, and a second flow cytometry analysis channel adapted to hydrodynamically focus a sample fluid in a second flow channel;

a first light source for providing a first light beam to at least part of the sample fluid in the first flow channel;

one or more first detectors for receiving at least some of the first light beam that passes through the sample fluid in the first flow channel and for providing one or more first detector output signals;

a second light source for providing a second light beam to at least part of the sample fluid in the second flow channel;

one or more second detectors for receiving at least some of the second light beam that passes through the sample fluid in the second flow channel and for providing one or more second detector output signals; and

a processing block coupled to the one or more first detector output signals and the one or more second detector output signals.

2. The cell analysis system of claim 1, wherein the processing block is adapted to determine one or more white blood cell parameters from the sample fluid in the first flow channel during a first measurement time period, and one or more red blood cell parameters of the sample fluid in the second flow channel in a second measurement time period.

3. The cell analysis system of claim 2 wherein the processing block is adapted to determine a total white blood cell count from the sample fluid in the first flow channel during the first measurement time period, as well as a type for at least some of the white blood cells that are counted as part of the total white blood cell count in the sample fluid in the first flow channel.

4. The cell analysis system of claim 3 wherein the processing block is adapted to determine a measure of white blood cell volume for at least some of the white blood cells that are counted as part of the total white blood cell count in the sample fluid in the first flow channel.

5. The cell analysis system of claim 2 wherein the processing block is adapted to determine a platelet count in the sample fluid in the second flow channel.

6. The cell analysis system of claim 2 wherein the processing block is adapted to determine a red blood cell count from the sample fluid in the second flow channel during the second measurement time period.

7. The cell analysis system of claim 6 wherein the processing block is adapted to determine a measure of red blood cell volume for at least some of the red blood cells that are counted as part of the red blood cell count in the sample fluid in the second flow channel.

8. The cell analysis system of claim 2 wherein the processing block is adapted to determine a measure of hemoglobin concentration.

9. A blood sample analysis system, comprising:

a disposable fluidic cartridge adapted to receive and at least partially process a blood sample;

an analyzer adapted to receive the disposable fluidic cartridge; and

once the blood sample is received by the disposable fluidic cartridge, and the analyzer is activated, the analyzer and disposable fluidic cartridge automatically processing the blood sample and determining one or more blood analysis parameters without further interaction from a user.

10. The blood sample analysis system of claim 9, wherein the one or more blood analysis parameters include a total white blood cell count.

11. The blood sample analysis system of claim 9, wherein the one or more blood analysis parameters include a differential white blood cell count for each of five types of white blood cells.

12. The blood sample analysis system of claim 9, wherein the one or more blood analysis parameters include a measure of a mean white blood cell volume.

13. The blood sample analysis system of claim 9, wherein the one or more blood analysis parameters include a red blood cell count.

14. The blood sample analysis system of claim 9, wherein the one or more blood analysis parameters include a platelet count.

15. The blood sample analysis system of claim 9, wherein the two or more blood analysis parameters include a measure related to a mean red blood cell volume.

16. The blood sample analysis system of claim 9, wherein the one or more blood analysis parameters include a differential white blood cell count for each of the five types of white blood cells, a red blood cell count and a platelet count.

17. The blood sample analysis system of claim 9, wherein the processing of the blood sample includes providing a first portion of the blood sample to a white blood cell measurement channel and a second portion of the blood sample to a red blood cell measurement channel in the disposable cartridge.

18. The blood sample analysis system of claim 17, wherein the red blood cells in the first portion of the blood sample are lysed in the white blood cell measurement channel.

19. The blood sample analysis system of claim 18, wherein the red blood cells in the second portion of the blood sample are sphered in the red blood cell measurement channel.

20. The blood sample analysis system of claim 19, wherein the sphered red blood cells are counted in the red blood cell measurement channel over a period of time using optical detection.

21. The blood sample analysis system of claim 18, wherein the white blood cells are counted in the white blood cell measurement channel over a period of time using optical detection.

22. The blood sample analysis system of claim 9, wherein the analyzer includes a housing that receives the disposable fluidic cartridge.

23. The blood sample analysis system of claim 22, wherein the disposable fluidic cartridge includes a white blood cell measurement channel and a red blood cell measurement channel.

24. The blood sample analysis system of claim 23, wherein:

the white blood cell measurement channel in the disposable cartridge includes a white blood cell flow cytometry analysis channel that is adapted to hydrodynamically focus a sample along a white blood cell flow channel and is further is adapted to support an optical light scattering measurement on the white blood cell flow channel;

the red blood cell measurement channel in the disposable cartridge includes a red blood cell flow cytometry analysis channel that is adapted to hydrodynamically focus a sample along a red blood cell flow channel and is further is adapted to support an optical light scattering measurement on the red blood cell flow channel; and

the disposable fluidic cartridge further including fluid directing means for directing flow of a first part of the blood sample to the white blood cell flow cytometry analysis channel and a second part of the blood sample to the red blood cell flow cytometry analysis channel.

25. The blood sample analysis system of claim 9, wherein the analyzer includes a display, and one or more output messages are displayed in the display.

26. The blood sample analysis system of claim 25, wherein the one or more output messages indicate if one or more, or a combination of one or more, of the blood analysis parameters are in a predefined range.

27. The blood sample analysis system of claim 25, wherein the one or more output messages indicate if one or more, or a combination of one or more, of the blood analysis parameters are outside of a predefined range.

28. A blood sample analysis system, comprising:

a removable cartridge adapted to receive a blood sample;

an analyzer adapted to receive the removable cartridge; and

once a blood sample is received by the removable cartridge, and the removable cartridge is received by the analyzer and the analyzer is activated, the analyzer and removable cartridge automatically processing the blood sample and determining one or more blood analysis parameters without further interaction from the user, and further displaying one or more output messages on a display, wherein the one or more output messages indicate if one or more, or a combination of one or more, of the blood analysis parameters are inside and/or outside of a predefined range.

29. A method for performing a sample analysis, the method comprising the steps of:

providing a sample to a disposable fluid cartridge;

loading the disposable fluid cartridge into an analyzer;

activating the analyzer;

obtaining a sample analysis result from the analyzer without any further interaction from a user.

30. The method of claim 29 wherein the analyzer is a blood sample analyzer and the sample is a blood sample.

31. The method of claim 29 wherein the disposable fluidic cartridge is a control disposable fluidic cartridge, and the method includes obtaining an analysis result using the control disposable fluidic cartridge and determining if the analysis result is within an expected range.

32. The method of claim 31 wherein a control disposable fluidic cartridge is inserted and analyzed at a relatively regular interval.

33. The method claim 31 further comprising inserting a disposable fluidic cartridge into the blood sample analyzer and providing a blood sample to the disposable fluidic cartridge one or more times before inserting the control disposable fluidic cartridge into the analyzer.

34. The method of claim 29 further comprising inserting a calibration disposable fluidic cartridge into the analyzer and obtaining an analysis result using the calibration disposable fluidic cartridge, and the analyzer adjusting one or more calibration parameters of the analyzer based on the results.

35. The method of claim 34 wherein the calibration disposable fluidic cartridge is inserted into the analyzer at a relatively regular interval.

36. An analyzer, comprising:

a fluidic cartridge having a flow channel and a flow sensor in fluid communication with the flow channel;

a pressure source for providing a flow of a fluid in the flow channel;

a controller coupled to the flow sensor, the controller adapted to detect one or more changes in flow rate through the flow channel.

37. The analyzer of claim 36 wherein the controller is adapted to detect one or more bubbles in the flow channel from the one or more changes in the flow rate.

38. The analyzer of claim 36 wherein the controller is adapted to detect an occlusion or partial occlusion in the flow channel from the one or more changes in the flow rate.

39. The analyzer of claim 36 wherein the flow sensor includes a heater element that, when energized, produces one or more heat pulses in the fluid, and further includes one or more heat sensors positioned upstream and/or downstream of the heater element to detect the one or more heat pulses.

40. The analyzer of claim 39 wherein the controller is adapted to detect one or more changes in the thermal conductivity of the fluid.

41. The analyzer of claim 39 wherein the controller is adapted to detect one or more bubbles in the fluid by the one or more changes in the thermal conductivity of the fluid.

42. The analyzer of claim 39 wherein the controller is adapted to detect one or more changes in the specific heat of the fluid.

43. The analyzer of claim 42 wherein the controller is adapted to detect one or more bubbles in the fluid by the one or more changes in the specific heat of the fluid.

45. The analyzer of claim 43 wherein the controller is adapted to detect one or more bubbles in the flow channel from the one or more changes in the impedance of the fluid in the flow channel.

44. An analyzer, comprising:

a fluidic cartridge having a flow channel and an impedance sensor in fluid communication with the flow channel;

a pressure source for providing a flow of a fluid in the flow channel;

a controller coupled to the impedance sensor, the controller adapted to detect one or more changes in the impedance of the fluid in the flow channel.

46. The analyzer of claim 44 wherein the controller is adapted to detect the presence of one or more unwanted objects in the flow channel from the one or more changes in the impedance of the fluid in the flow channel.