AUTOMATED SAMPLE HANDLING INSTRUMENTATION, SYSTEMS, PROCESSES, AND METHODS

• US 20130065797A1
• Filed: 09/10/2012
• Published: 03/14/2013
• Est. Priority Date: 09/09/2011
• Status: Active Grant

• Current Assignee: Gen-Probe Incorporated (Hologic Incorporated)
• Original Assignee: Gen-Probe Incorporated (Hologic Incorporated)
• Inventors: SILBERT, Rolf, OPALSKY, David
• Granted Patent: US 9,335,336 B2
• Time in Patent Office: Days
• US Class Current: 506/39
• CPC Class Codes: B67B 7/00 Hand- or power-operated devices for opening closed containers nail pullers or extractors B25C11/00; attached to, or incorporated in, containers or container closures B65D75/58, B65D77/30
• CPC Class Codes: C40B 60/12 for screening libraries
• CPC Class Codes: G01F 23/265 for discrete levels
• CPC Class Codes: G01N 1/28 Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Qmounting specimens on microscopic slides G02B21/34; means for supporting the objects or the materials to be analysed in electron microscopes H01J37/20 ; laboratory gas handling apparatus B01L5/00
• CPC Class Codes: G01N 1/31 Apparatus therefor
• CPC Class Codes: G01N 2035/00524 Mixing by agitating sample carrier
• CPC Class Codes: G01N 2035/00752 bar codes
• CPC Class Codes: G01N 2035/00811 consumable or exchangeable components other than sample carriers, e.g. detectors, flow cells
• CPC Class Codes: G01N 2035/00831 identification of the sample, e.g. patient identity, place of sampling
• CPC Class Codes: G01N 2035/00861 printing and sticking of identifiers
• CPC Class Codes: G01N 2035/0405 manipulating closing or opening means, e.g. stoppers, screw caps, lids or covers
• CPC Class Codes: G01N 2035/1018 Detecting inhomogeneities, e.g. foam, bubbles, clots
• CPC Class Codes: G01N 2035/1046 Levitated, suspended drops
• CPC Class Codes: G01N 2035/1048 using the transfer device for another function
• CPC Class Codes: G01N 2035/1051 for transporting containers, e.g. retained by friction
• CPC Class Codes: G01N 2035/1062 for testing the liquid while it is in the transfer device
• CPC Class Codes: G01N 35/00732 Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: G01N 35/0099 comprising robots or similar manipulators robots per se B25J
• CPC Class Codes: G01N 35/025 having a carousel or turntable for reaction cells or cuvettes
• CPC Class Codes: G01N 35/04 Details of the conveyor system G01N35/021 - G01N35/028 take precedence
• CPC Class Codes: G01N 35/1002 : Reagent dispensers
• CPC Class Codes: G01N 35/1004 : Cleaning sample transfer devices
• CPC Class Codes: G01N 35/1016 : Control of the volume dispensed or introduced
• CPC Class Codes: G01N 35/1079 : with means for piercing stoppers or septums

Abstract

The present invention provides a processing station for automatically processing a biological sample, a system for automated real-time inventory control of consumables within a biological sample handling or assay instrument, a high throughput random access automated instrument for processing biological samples, an automated instrument for processing or analysis of a sample, and processes for automated mucoid detection and elimination. Methods of using the disclosed instruments, mucoid detection processes, and systems to process and/or analyze samples are also disclosed.

Claims

1. A processing station for automatically processing a biological sample, comprising:

(a) a rotatable platform capable of mixing a biological sample, wherein the platform rotates around a central axis;

(b) two or more container holders arranged on the X-Y plane in spatially distinct locations on the rotatable platform, wherein the container holders are adapted to hold different shaped containers such that two or more different container holders are present;

(c) a capping/decapping mechanism capable of capping/decapping the two or more different containers, wherein each of the two or more different containers have a different shape and/or a different shaped cap;

(d) a data scanning mechanism capable of acquiring information about a container or its contents, wherein the data scanning mechanism is arranged such that the container can be scanned while positioned in one of the two or more container holders; and

(e) a mucoid detection mechanism.

2. The processing station of claim 1, further comprising a drip tray arranged to be movably positioned under the one or more capping/decapping mechanisms.

3. The processing station of claims 1, wherein the mucoid detection mechanism comprises machine vision, reverse capacitive liquid level detection, or a combination thereof.

4. The processing station of claim 1, wherein the processing station is positioned in a sample processing instrument comprising a sample input rack, a sample output rack, and incubator, a pipette tip tray, a reagent container, and a waste bin.

5. The processing station of claim 4, further comprising an instrument inventory management system.

6. The processing station of claim 5, wherein the instrument inventory management system monitors the inventory of sample containers and reaction vessels in the input rack, the incubator, and/or the output rack.

7. The processing station of claim 6, wherein the instrument inventory management system further monitors the number of pipette tips positioned in the tip tray and/or the capacity of the solid waste bin.

8. The processing station of claim 4, wherein the instrument inventory management system is an automated real-time instrument inventory management system.

9. The processing station of claim 4, wherein the instrument inventory management system comprises (1) a camera and an associated image processor, and/or (2) a proximity sensor and a barcode reader.

10. The processing station of claim 9, wherein the camera is statically mounted in optical communication with at least one instrument consumable.

11. The processing station of claim 9, wherein the camera is mounted on the robot arm.

12. The processing station of claim 1, wherein two or more container holders are positioned on the periphery of the rotatable platform.

13. The processing station of claim 1, wherein each container holder is rotatable around an individual secondary axis of rotation that is different than the secondary axis of each other container holder.

14. The processing station of claim 1, wherein the vortexing comprises orbital mixing.

15. The processing station of claim 14, wherein the orbital mixing comprises rotation of the rotatable platform circularly around the central axis together with rotation of the two or more container holders circularly around their secondary axes in a direction opposite of the rotation of the rotatable platform.

16. The processing station of claim 1, further comprising a power line communication system.

17. The processing station of claim 1, wherein the station comprises three container holders.

18. The processing station of claim 1, wherein the drip tray is translatable in the X-Y plane.

19. The processing station of claim 18, wherein the translation in the X-Y plane of the drip tray comprises rotation about a tertiary axis that is different than the central axis of the rotatable platform.

20. The processing station of claim 19, wherein the drip tray extends outwardly from the tertiary axis.

21. The processing station of claim 20, wherein the extension is effected by way of an arm, post, plate, panel, or blade extending outwardly from the tertiary axis.

22. The processing station of claim 2, wherein the drip tray is translatable in the X-, Y-, and/or Z-planes.

23. The processing station of claim 1, wherein the different containers comprise containers having differing widths, heights, diameters, and/or a combination thereof.

24. The processing station of claim 1, wherein the data scanning mechanism comprises a barcode scanner.

25. The processing station of claim 24, wherein the barcode scanner is utilized to determine the centerline and/or position of a barcode on a sample container or reaction vessel.

26. A process of automated mucoid strand detection and elimination from a sample aspiration device comprising:

(a) placing the sample aspiration device in a vessel containing a biological sample, wherein the vessel has closed bottom portion and an open top portion;

(b) aspirating at least a portion of the sample;

(c) withdrawing the sample aspiration device from the sample;

(d) while the sample aspiration device is withdrawn from the sample, imaging at least a portion of the sample aspiration device and processing the imaging results to detect whether a mucoid strand is present on the sample aspiration device,

wherein if a mucoid strand is detected, the sample is dispensed into the vessel and steps (a)-(d) are repeated until a mucoid strand is not detected.

27. The process of claim 26, wherein if a mucoid strand is detected in step (d), the repeated step (b) is performed in a different portion of the container versus the initial or previous step (b).

28. The process of claim 26, wherein the sample aspiration device is imaged with machine vision.

29. The process of claim 26, wherein the imaging processing occurs automatically without manual user input.

30. The process of any one of claim 26, wherein step (c) comprises separating the sample aspiration device from the fluid remaining in the vessel.

31. The process of any one of claim 26, wherein the vessel is vortexed prior to step (a).

32. The process of any one of claim 26, wherein the sample aspiration device comprises a pipette tip positioned operably on a pipettor.

33. The process of any one of claim 26, wherein if a mucoid strand is detected, the sample is vortexed prior to repeating any process steps after dispense of the sample into the vessel.

34. The process of any one of claim 26, wherein the sample aspiration device is positioned operably on a pipettor capable of performing capacitive liquid level detection and/or reverse capacitive liquid level detection.

35. The process of any one of claim 26, wherein the imaging comprises imaging of at least the tip of the sample aspiration device.

36. The process of any one of claim 26, wherein steps (b) and (c) occur with the sample aspiration device positioned directly over the open top portion of the vessel.

37. A system for automated real-time inventory control of consumables within a biological sample handling or assay instrument, comprising

(a) one or more consumable types, each comprising more than one unit of the consumable;

(b) an image collection device in optical communication with the one or more consumable types; and

(c) an image processor,

wherein the image collection device captures an image of the one or more consumable types and the image is automatically processed to determine the unit number, position, and/or presence or absence of the one or more consumable types.

38. The system of claim 37, wherein the one or more consumable types are backlit from a position opposed to the location of the image collection device, such that the image collection device is in optical communication with the resulting backlighting illumination.

39. The system of claim 37, wherein the consumable type is a pipette tip, a sample container, a reaction vessel, an input rack, an output rack, or a reagent.

40. The system of claim 37, wherein the image collection device is statically mounted in optical communication with the one or more consumable types.

41. The system of claim 37, wherein the image collection device is movably mounted in optical communication with the one or more consumable types.

42. The system of claim 41, wherein the image collection device is mounted on a robot arm.

43. The system of claim 37, wherein the image processor is comprised within the image capture device.

44. The system of claim 37, comprising two or more image capture devices and image processors.

45. The system of claim 44, wherein each of the two or more image capture devices is in optical communication with a single consumable type.

46. The system of claim 44, wherein each of the two or more image capture devices is in optical communication with two or more consumable types.

48. The system of claim 46, wherein image capture device captures an image of the one or more consumable types and the waste bin in a single image.

49. The system of claim 37, further comprising an operator notification protocol, wherein the operator is notified in real-time about the inventory of the one or more consumable types detected during imaging and image processing.

50. The system claim 37, further comprising a power line communication system.

47. The system of claim 47, wherein the image capture device is positioned in optical communication with a waste bin wherein the image collection device captures an image of the waste bin and the image is automatically processed to determine the presence and/or remaining capacity of the waste bin.

51. A high throughput, random access automated instrument for processing biological samples, comprising:

(a) a sample processing station;

(b) a system for automated real-time inventory control of consumables;

(c) a sample input bay configured to hold one or more sample input racks;

(d) a sample output bay configured to hold one or more sample output racks;

(e) a power line communication system;

(f) a waste bin;

(g) a consumable inventory bay;

(h) a robot arm having a pipettor operably positioned thereon;

(i) a pick-and-place mechanism for moving a container within the instrument; and

(j) a user interface.

52. The instrument of claim 51, wherein the instrument comprises an automated system for identifying and processing a failed sample processing protocol such that the failed sample is identifiable to a user of the instrument and/or a downstream automated molecular instrument.

53. The instrument of claim 52, wherein the automated system for identifying and processing a failed sample processes a failed sample in a manner that does not affect the overall throughput speed of the instrument.

54. The instrument of claim 51, further comprising a printer module for use in printing a barcode on a reaction receptacle or a sample container.

55. The instrument of claim 54, wherein the printer module is in data communication with a barcode reader such that a barcode read by the barcode reader can be reproduced by the printer module.

56. An automated instrument for processing or analysis of a sample comprising:

(a) a barcode reader; and

(b) a printer module in data communication with the barcode reader,

wherein the processing or analysis of the sample comprises automated transfer of at least a portion of the sample from a first receptacle to a second receptacle, and wherein the barcode reader scans a barcode present on the first receptacle, information associated with the barcode is transferred between the barcode reader and the printer module, and the printer module prints a barcode on the second receptacle.

57. The instrument of claim 56, wherein the first receptacle comprises a sample container and the second receptacle comprised a reaction vessel.

58. The instrument of claim 56, wherein the barcode printed on the second receptacle is the same barcode present on the first receptacle.

59. The instrument of claim 56, wherein the barcode printed on the second receptacle is a different barcode versus the barcode present on the first receptacle.

60. The instrument of claim 59, wherein the information associated with the barcode printed on the second receptacle comprises the information associated with the barcode present on the first receptacle and further comprises additional information.