PORTABLE SAMPLE ANALYZER SYSTEM

• US 20070172388A1
• Filed: 12/22/2006
• Published: 07/26/2007
• Est. Priority Date: 05/14/2004
• Status: Active Grant

• Current Assignee: Honeywell International Inc.
• Original Assignee: Honeywell International Inc.
• Inventors: Rezachek, Tom, Padmanabhan, Aravind, Fritz, Bernard, Cabuz, Cleopatra, Reutiman, Peter, Bardell, Ron, Cox, James
• Granted Patent: US 8,323,564 B2
• Time in Patent Office: Days
• US Class Current: 422/58
• 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 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2200/143 Quality control, feedback systems
• CPC Class Codes: B01L 2200/146 Employing pressure sensors
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/0627 Sensor or part of a sensor is integrated
• 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 3/502723 characterised by venting arrangements
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/502746 characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence
• CPC Class Codes: B01L 9/527 for microfluidic devices, e.g. used for lab-on-a-chip
• CPC Class Codes: G01N 15/1404 Handling flow, e.g. hydrodynamic focusing
• CPC Class Codes: G01N 15/1459 the analysis being performed on a sample stream
• CPC Class Codes: G01N 15/1484 : microstructural devices
• CPC Class Codes: G01N 2015/011 : with lysing, e.g. of erythrocytes
• CPC Class Codes: G01N 2015/012 : Red blood cells
• CPC Class Codes: G01N 2015/016 : White blood cells
• CPC Class Codes: G01N 2015/018 : Platelets
• CPC Class Codes: G01N 2015/1452 : Adjustment of focus; Alignment
• CPC Class Codes: G01N 2015/1486 : Counting the particles
• CPC Class Codes: G01N 2035/00148 : Test cards, e.g. Biomerieux or McDonnel multiwell test cards
• CPC Class Codes: G01N 2035/00247 : Microvalves
• CPC Class Codes: G01N 2035/1034 : Transferring microquantities of liquid
• CPC Class Codes: G01N 2035/1053 : for separating part of the liquid, e.g. filters, extraction phase
• CPC Class Codes: G01N 21/53 : within a flowing fluid, e.g. smoke
• CPC Class Codes: G01N 2291/02433 : Gases in liquids, e.g. bubbles, foams
• CPC Class Codes: G01N 2291/02836 : Flow rate, liquid level
• CPC Class Codes: G01N 2291/02872 : Pressure
• CPC Class Codes: G01N 29/032 : by measuring attenuation of acoustic waves
• CPC Class Codes: G01N 35/00603 : Reinspection of samples
• CPC Class Codes: G01N 35/00663 : of consumables

Abstract

A system relating to sample analyzers, and more particular, to sample analyzers that are simple to operate and have a reduced risk of providing an erroneous result to a user. In some cases, the sample analyzer may be a portable sample analyzer that includes a disposable fluidic cartridge. The operators of the analyzers need not be trained.

Claims

1. A sample analyzer comprising:

an instrument having a slot; and

a cartridge for insertion into the slot;

a light source proximate to the cartridge when inserted in the slot; and

a detector proximate to the cartridge when inserted in the slot; and

wherein;

the flow channel comprises a channel wall;

the channel wall has a first index of refraction;

a sample fluid in the flow channel has a second index of refraction; and

the light source is for projecting light into the flow channel.

2. The analyzer of claim 1, wherein:

the detector is for detecting light reflected from an interface of the first and second indices of refraction;

light detected by the detector is indicative of the index of refraction of the fluid; and

if the index of refraction of the fluid is not within a specified range, then the sample analyzer may not perform an analysis, not provide a result, indicate an incorrect fluid, and/or provide an error indication.

3. The analyzer of claim 1, wherein the channel wall is sufficiently thin to permit optical tunneling if a delta between the first and second indices of refraction is within a range for the fluid to be satisfactory.

4. The analyzer of claim 1, wherein if the index of refraction of the fluid is not within the specified range the fluid may be a incorrect specimen or sample, have an incorrect reagent, bubbles, clots, contaminants, and/or the like.

5. The analyzer of claim 1, wherein:

the detector is for detecting light going through the channel wall and the fluid and out of the channel through the channel wall;

the light to the detector is indicative of an index of refraction of the fluid; and

if the index of refraction of the volume is not within a specified range for an appropriate sample fluid, then the sample analyzer may not perform an analysis, not provide a result, indicate an incorrect sample fluid, and/or provide an error indication.

6. A sample analyzer comprising:

an instrument having a slot, an energy source and a detector; and

a cartridge, having at least one flow channel, for insertion into the slot.

7. The analyzer of claim 6, wherein:

the energy source is for providing light through the flow channel at an angle relative to a wall of the flow channel;

the detector is for detecting a magnitude of scattered light from the flow channel;

a magnitude of a certain range is indicative of undesirable particles or bubbles in a fluid in the flow channel; and

if the magnitude of the certain range is detected, then the analyzer may not provide a result or may provide an error indication.

8. The analyzer of claim 6, wherein:

the energy source is an ultrasound transducer, adjacent to the flow channel, for transmitting ultrasound into the flow channel;

the detector is an ultrasound receiver, adjacent to the flow channel, for receiving reflected ultrasound energy from the flow channel;

reflected ultrasound energy having a magnitude of a certain range is indicative of bubbles or other undesirable particles in the flow channel; and

if reflected ultrasound energy having a magnitude of a certain range is received by the ultrasound receiver, then the analyzer would not provide a result and/or would provide an error indication.

9. The analyzer of claim 6, wherein:

the energy source is a pressure source for applying a certain change of pressure to a sample fluid in the flow channel;

the detector is a flow sensor, situated in the flow channel, for monitoring a flow rate in the flow channel;

a flow rate of the sample fluid is monitored by the flow sensor while a certain change of pressure is applied by the pressure source to the fluid in the flow channel;

a flow rate change per unit of time for the certain change of pressure indicates an amount of compressibility of the sample fluid; and

the amount of compressibility of a specific range is indicative of bubbles in the sample fluid.

10. The analyzer of claim 9, wherein the pressure source is a high frequency pulse piezoresistive pressure source.

11. The analyzer of claim 9, if bubbles are indicated to be in the sample fluid in the flow channel, the analyzer will not provide a result and/or will provide an error indication.

12. The analyzer of claim 6, wherein:

the energy source is a pressure transducer for transmitting a pressure pulse in a sample fluid in the flow channel, at a first location along the flow channel to a terminal end of the sample fluid;

the detector is a pressure receiver for receiving the pressure pulse reflected by the terminal end of the fluid, at a second location along the flow channel; and

a duration of time between transmitting a pressure pulse down the flow channel and receiving the reflected pulse is indicative of a location of the terminal end along the flow channel relative to the first and second locations.

13. The analyzer of claim 6, wherein:

the energy source is a pressure transducer for transmitting a pressure pulse in a sample fluid in the flow channel, at a first location along the flow channel to a terminal end of the sample fluid;

the detector is a pressure receiver for receiving the pressure pulse reflected by the terminal end of the fluid, at a second location along the flow channel; and

a duration of time between transmitting a pressure pulse down the flow channel and receiving the reflected pulse is indicative of a location of the terminal end along the flow channel relative to the first and second locations.

14. The analyzer of claim 6, wherein:

the energy source is a pressure transducer for transmitting a pressure pulse in a first fluid in a first flow channel;

the detector is a pressure receiver for receiving the pressure pulse from a second fluid in a second flow channel;

a first fluid having a terminal end is in the first flow channel;

a second fluid having a terminal end is in the second flow channel; and

if a pressure pulse is produced in the first fluid by the pressure transducer, a significant pressure pulse signal will appear at the pressure receiver upon a meeting of the terminal ends of the first and second fluids.

15. A sample analyzer comprising:

an instrument having a slot;

a cartridge for insertion into the slot; and

a level sensor attached to the analyzer; and

wherein if the level sensor indicates insufficient levelness of the analyzer, the analyzer may not perform an analysis, not provide a result, and/or will provide an error indication.

16. A sample analyzer comprising:

an instrument having a slot;

a cartridge, having one or more flow channels, for insertion into the slot;

one or more flow sensors situated in the one or more flow channels, respectively;

if flow rates indicated by the one or more flow sensors are outside of an expected range of flow rates, then the analyzer may be deemed not sufficiently level, and then the analyzer may not perform an analysis, not provide a result, and/or will provide an error indication.

17. A sample analyzer comprising:

an instrument having a slot;

a cartridge, having one or more flow channels, for insertion into the slot;

one or more flow sensors situated in the one or more flow channels, respectively;

if flow rates indicated by the one or more flow sensors are outside of an expected range of flow rates, then a fluid in the one or more flow channels may be deemed incorrect, and then the analyzer may not perform an analysis, not provide a result, may indicate an incorrect fluid, and/or will provide an error indication.

18. A sample analyzer comprising:

an instrument having a slot;

a cartridge, having at least one flow channel, for insertion into the slot;

wherein;

the instrument has a first structural fitting;

the card has a second structural fitting for mating with the first structural fitting;

the first and second structural fittings permit the card to be inserted in only a proper orientation.

19. A sample analyzer comprising:

an instrument having fluid ports; and

a card insertable in the instrument; and

wherein;

the card, having a proper orientation when inserted in the instrument, has fluid ports that align with and connect to the fluid ports of the instrument;

the fluid ports of the instrument have flow sensors for measuring flows through the fluid ports, respectively;

if flow sensors do not indicate expected flows through the fluid ports, then one or more fluid ports of the card do not align with and connect to the fluid ports of the instrument indicating that the card may have improper orientation of insertion in the instrument, and the analyzer may not perform an analysis, not provide a result, and/or will provide an error indication.

20. sample analyzer comprising:

an instrument having one or more optical windows;

a card, having one or more optical windows situated to one or more channels or paths, the card being insertable in the instrument;

the card, having a proper orientation when inserted in the instrument, has the one or more windows that are optically aligned with the one or more windows of the instrument;

if an expected optical communication between the one or more windows of the card and the one or more windows of the instrument does not occur, then the sample analyzer may not perform an analysis, not provide a result, and/or will provide an error indication.

21. A sample analyzer comprising:

an instrument having a receptacle with a reader; and

a component, having a tag, insertable in the receptacle.

22. The analyzer of claim 21, wherein:

the component is a reagent container;

the tag is a code for indicating parameters of contents in the reagent container;

if the reagent container is placed in the receptacle, then the code on the reagent container may be read by the reader to determine the correctness of the parameters;

if one or more of the parameters are incorrect, then the sample analyzer may not perform an analysis, not provide a result, will indicate an incorrect reagent, and/or will provide an error indication.

23. The analyzer of claim 21, wherein:

the component is a cartridge;

the tag is a barcode comprising parameters such as a cartridge ID, analysis type(s) supported by cartridge, cartridge calibration parameters, timing for operation of the cartridge, input pressures, flow rates, software, software updates, and/or the like;

if the reader notes the parameters to be compatible with the instrument, then the sample analyzer may perform an analysis; and

if the reader notes the parameters not to be compatible with the instrument, then the sample analyzer may not perform an analysis, not provide a result, and/or will provide an error indication.

24. The analyzer of claim 21, wherein:

the component is a cartridge;

the cartridge has on-board reagents;

the tag is a barcode comprising information indicating type(s), date and data of manufacture, expiration data, and/or other parameters, of each on-board reagent; and

if the reader notes the information on the barcode of the cartridge not to be compatible with the instrument, then the sample analyzer may not perform an analysis, not provide a result, and/or will provide an error indication.

25. The analyzer of claim 21, wherein:

the component is a cartridge;

the tag is an RFID tag;

the RFID tag comprising information of cartridge ID, analysis type(s) supported by cartridge, cartridge calibration parameters, timing parameters for operation of the cartridge, input pressures, flow rates, software, software updates, and/or the like;

if the reader notes the information to be compatible with the instrument, then the sample analyzer may perform an analysis; and

if the reader notes the information not to be compatible with the instrument, then the sample analyzer may not perform an analysis, not provide a result, and/or will provide an error indication.

26. The analyzer of claim 21, wherein:

the component is a cartridge the tag is an RFID tag;

the cartridge has on-board reagents;

the RFID tag indicates type(s), date and data of manufacture, expiration data, and/or other parameters of each on-board reagent; and

if the reader notes the information from the RFID tag of the cartridge not to be correct or compatible with the instrument, then the sample analyzer may not perform an analysis, not provide a result, and/or will provide an error indication.

27. The analyzer of claim 21, wherein:

the component is a cartridge

the tag is a humidity/moisture indicator, a time indicator, and/or a maximum and/or minimum temperature indicator;

the reader is an optical interrogator;

the humidity/moisture indicator has a color change for the optical interrogator to read;

the time indicator has a color change for the optical interrogator to read; and

the maximum and/or minimum temperature indicator has a color change for the optical interrogator to read.

28. The analyzer of claim 27, wherein if the optical interrogator reads maximum and/or minimum temperature detectors, the humidity/moisture indicator, and/or the time indicator to be unacceptable, then the sample analyzer may not perform an analysis, not provide a result, and/or will provide an error indication.

29. The analyzer of claim 28, wherein if the optical interrogator reads maximum and/or minimum temperature detectors, the humidity/moisture indicator, and/or the time indicator to be unacceptable, then the reagents and/or a fluid sample is spoiled or incorrect.

30. A sample analyzer comprising:

a built-in-self-test to provide scan chain test, before, during and/or after analysis run; and

the test covers controllable and observable modes within circuits.

31. A sample analyzer comprising:

an instrument having one or more windows; and

a cartridge, having one or more windows aligned with the one more windows of the instrument, respectively, insertable in the instrument; and

wherein before an analysis run, a check for cracks, dirt or other debris on one or more windows using optical scatter, reflective and/or transmissive measurement.

32. The analyzer of claim 31, wherein if optical scatter, reflective and/or transmissive measurement is deemed unsatisfactory, the sample analyzer may not perform an analysis, not provide a result, and/or will provide an error indication.

33. A sample analyzer comprising:

an instrument;

a cartridge having one or more flow channels;

wherein;

each of the one or more flow channels has at least one flow sensor associated with it

each flow sensor output is monitored before, during and/or after an analysis run;

each flow sensor output is checked to determine whether it is within an expected range and/or flow profile; and

if one of the flow sensor outputs is deemed not to be within an expected range and/or flow profile, the sample analyzer may not perform an analysis, not provide a result, and/or will provide an error indication.

34. A sample analyzer comprising:

an instrument;

a cartridge insertable in the instrument;

wherein;

the instrument comprises;

an AC power input; and

a battery power backup.

35. A sample analyzer comprising:

an instrument;

a cartridge insertable in the instrument;

a hardware self-check for before, during and/or after an analysis run; and

a software self-check for before, during and/or after an analysis run.

36. sample analyzer comprising:

an instrument;

a cartridge insertable in the instrument; and

an internet/network communication connection connected to the instrument; and

wherein the internet/network communication connection comprises;

delivery of results of an analysis run to a remote location;

upgrades of software of analyzer from a remote location; and

/or

provides cartridge reject information to a remote location.

37. The analyzer of claim 36, wherein the internet/network communication connection provides a service dispatched to correct a problem of an analyzer having high error rates and/or identification of errors.

38. The analyzer of claim 36, wherein the internet/network communication connection provides aggregated results from a plurality of sample analyzers to identify common problems and/or corrections for hardware and/or software.

39. The analyzer of claim 36, wherein the internet/network communication connection provides environmental parameters to a remote site periodically, on demand, or upon an environmental parameter exceeding an assigned limit.

40. The analyzer of claim 39 wherein environmental parameters comprise temperature, humidity, impact, tilt, power failure, analyzer usage, and/or other data.

41. A sample analyzer comprising:

an instrument;

a cartridge insertable in the instrument; and

a wireless communication connection connected to the instrument; and

wherein the wireless communication connection comprises;

delivery of results of an analysis run to a remote location;

upgrades of software of analyzer from a remote location; and

/or

providing cartridge reject information to a remote location.

42. The analyzer of claim 41, wherein the wireless communication connection incorporates a protocol that meets ordinarily accepted standards of a pertinent wireless community.

43. The analyzer of claim 41, wherein the wireless communication connection provides a service dispatched to correct a problem of an analyzer having high error rates and/or identification of errors.

44. The analyzer of claim 41, wherein the wireless communication connection provides aggregated results from a plurality of sample analyzers to identify common problems and/or corrections for hardware and/or software.

45. A sample analyzer comprising:

an instrument having a slot; and

a cartridge, having a flow channel, for insertion into the slot; and

wherein;

the flow channel has a flow sensor;

if the channel is depressurized with a fluid, the flow sensor may measure a flow rate of the fluid caused by gravity level;

the flow rate is indicative of the level of the analyzer;

if the level of the analyzer is not within a specified range, the analyzer may not perform an analysis, not provide a result, and/or will provide an error indication.

46. A sample analyzer comprising:

an instrument;

a cartridge insertable in the instrument; and

a shock/vibration sensor attached to the instrument; and

wherein;

shock/vibration may be detected by the sensor before, during and/or after analysis; and

if the shock/vibration exceeds a specified magnitude acceptable for analyzer operation, then the analyzer may not perform an analysis, not provide a result, and/or will provide an error indication.

47. A sample analyzer comprising:

an instrument;

a cartridge insertable in the instrument; and

at least one interface between a fluid reservoir and a channel on the cartridge; and

wherein;

the interface comprises;

a septum on the channel; and

a hollow needle connected to the reservoir; and

the needle is for piercing the septum and conveying fluid from the reservoir to the channel and for withdrawing from the septum and permitting the septum to self-seal since the piercing does not core the septum.

48. A sample analyzer comprising:

an instrument;

a cartridge insertable in the instrument;

a reservoir situated in the cartridge;

a membrane being an exterior wall of the reservoir; and

a shaft situated in the instrument and adjacent to the membrane when the cartridge is inserted in the instrument; and

wherein if fluid is to be moved from the reservoir of the cartridge when inserted, the shaft may be moved into contact with the membrane and push the membrane in to move fluid from the reservoir.

49. A sample analyzer comprising:

an instrument;

a cartridge insertable in the instrument;

a reservoir situated in the cartridge;

a first membrane being an exterior wall of the reservoir; and

a second membrane situated on an end of an actuator situated in the instrument and adjacent to the first membrane when the cartridge is inserted in the instrument; and

wherein if fluid is pumped into the end of the actuator, the second membrane deforms against the first membrane to be moved in towards the reservoir of the cartridge when inserted, and push the first membrane in to move fluid from the reservoir.