Device, System and Method for Processing a Sample

• US 20110143339A1
• Filed: 07/18/2008
• Published: 06/16/2011
• Est. Priority Date: 08/17/2007
• Status: Active Grant

• Current Assignee: Diagnostics for the Real World, Ltd.
• Original Assignee: Diagnostics for the Real World, Ltd.
• Inventors: Wisniewski, Craig
• Granted Patent: US 9,707,556 B2
• Time in Patent Office: Days
• US Class Current: 435/6.1
• CPC Class Codes: B01L 2200/0642 Filling fluids into wells by specific techniques
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2200/12 Specific details about manufacturing devices
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/049 Valves integrated in closure
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2300/123 Flexible; Elastomeric
• CPC Class Codes: B01L 2300/1827 using resistive heater
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/049 vacuum
• CPC Class Codes: B01L 2400/0638 membrane valves, flap valves
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 9/527 for microfluidic devices, e.g. used for lab-on-a-chip
• CPC Class Codes: G01N 2035/00366 Several different temperatures used
• CPC Class Codes: G01N 2035/00534 Mixing by a special element, e.g. stirrer

Abstract

A device for processing a sample comprises a blister defined by first and second walls. The first wall is flexible allowing the blister to be divided into one or more sealed regions by an external pressure applied to a portion of the first wall. The external pressure is applied in the form of a 2-dimensional shape to form a sealed region having that shape.

Claims

1. A device for the processing of a sample comprising,

a blister defined between first and second walls wherein the first wall is flexible such that the blister can be divided into one or more sealed regions by an external pressure applied to a portion of the first wall that urges the first wall towards the second wall, the pressure being applied in the form of a two dimensional shape to form a sealed region in that shape.

6. A device according to claim 1 in which the first wall is flexible such that a localised external pressure urging a portion of the first wall towards the second wall can produce a localised seal.

7. A device according to claim 1 in which an object is retained at a location within the blister.

8. A device according to claim 7 in which the object comprises a dried reagent or a sachet of liquid.

9. A device according to claim 1 in which the first wall is shaped, or has a plurality of dimples, for locating objects at predetermined locations within the blister.

10. A device according to claim 1 in which the second wall has recesses for locating objects.

11. A device according to claim 1, further comprising a sample introduction port to allow introduction of the sample into the blister.

12. A device according to claim 1, further comprising a vacuum port to allow removal of air or a gas from the blister.

13. A device according to claim 1, further comprising a gasket disposed within the blister, in which localised pressure urging the first wall towards the second wall with the gasket in-between can form a localised seal.

14. A device according to claim 13 in which the gasket comprises a material that is disposed on the second wall within the blister to define one or more sealable regions in the blister, the sealable regions being sealable on application of a suitable external force or pressure.

15. A device according to claim 1 in which the blister can be divided into one or more sealed regions by application of one or more shaped platens that urge the first wall towards the second wall.

16. A device according to claim 15 in which the sealed regions can be sealed and unsealed sequentially to allow the sample and/or reagents to pass between the regions in a predetermined manner.

17. A device according to claim 15 in which one or more of the sealed regions contains a processing reagent or processing reagents and removal of the seals allows the sample to contact the processing reagent or reagents.

18. A device according to claim 1 in which the sample may be mixed by an oscillating external pressure applied to at least a portion of the blister.

19. A device according to claim 1, further comprising an analysis means.

20. A device according to claim 19 in which the analysis means is located within a sealable region of the blister.

21. A device according to claim 19 in which the analysis means is located in an analysis chamber in communication with the blister.

22. A device according to claim 21 in which the second wall has an exit port to allow passage of a processed sample from the blister to the analysis chamber.

23. A device according to claim 19 in which the analysis means comprises a test strip.

24. A device according claim 1 in which the second wall is a base plate and the first wall is a flexible film disposed on the base plate.

25. A device according to claim 1 for the processing of a biological, chemical or environmental sample.

26. A device according to claim 1 for the amplification and detection of nucleic acid or genetic material in a biological or environmental sample.

27. A device according to claim 1 in which the blister is sealed from the external environment.

2-5. -5. (canceled)

28-31. -31. (canceled)

32. A method of processing a sample in a device having blister defined between a first wall and a second wall, in which at least the first wall is flexible, comprising the steps of,

applying a localised external pressure to urge the first wall towards the second wall to form first and second sealed regions within the blister,

introducing a liquid sample to the first sealed region, and

removing the localised pressure to open the seal between the first and second sealed regions.

33. A method according to claim 32 in which the blister is preloaded with dried reagents held at predetermined locations and after applying the external pressure a first reagent is located in the first sealed region and a second reagent is located in the second sealed region.

34. A method according to claim 32 in which a processing step such as incubating, heating or mixing occurs in the first sealed region before the seal is opened between the first and second sealed regions.

35. A method according to claim 32 in which the localised external pressure is applied by a shaped platen or tool.

36. A method according to claim 32 in which more than two sealed regions are formable within the blister.

37. A method according to claim 35 in which a plurality of tools or platens are used to apply the external pressure to form the more than two sealed regions within the blister.

38. A method according to claim 36 in which seals separating each of the more than two sealed regions are opened in sequence to allow the sample to communicate with each region in order as it is processed.

39. A method according to claim 32 in which the sample is mixed by oscillation of the tool or platen against the first wall.

40. A method according to claim 32 in which the device contains a liquid buffer or reagent contained in a sachet that is located in the blister, the liquid being releasable by the application of an external pressure to the sachet.

41. A method according to claim 32 in which the sample is moveable within the blister by the application of external pressure from tools or platens.

42. A method according to claim 32 in which the sample undergoes a protocol suitable for amplification of a nucleic acid or genetic material.

43. A method according to claim 32, further comprising a step of analysing the sample.

44. A method according to claim 43 in which analysis is carried out by contacting the processed sample with a test strip located within the device.

45. A method according to claim 32, further including the step of loading the device into a machine for automatically performing the processing steps on the sample.

46. A method according to claim 45 including a step of removing the device containing the processed sample from the machine and disposing of it.

47. A method according to claim 32 in which the device undergoes a decontamination procedure after processing the sample.

48. A method according to claim 32 in which an external pressure is applied to a portion of the first wall to isolate or separate a predetermined volume of liquid within the blister.

49. A method according to claim 32, further comprising the steps of applying a vacuum to the blister to facilitate introduction of the sample and/or transfer of liquid within the device and/or mixing of reagents and the sample and or sealing portions of the device and/or locating objects within the device.

50. A machine for the automatic processing of a sample in a device according to any preceding device claim, the machine comprising a bay for receiving the device and a tool or platen for applying a localised external pressure to the device when loaded in the machine.

51. A machine according to claim 50 having a plurality of tools or platens adapted to interact with a device loaded in the machine.

52. A machine according claim 50 further comprising a heater for applying heat to a device loaded in the machine or a cooler for removing heat from a device loaded in the machine.

53. A machine according to claim 50 having an actuatable substantially tube shaped platen.

54. A machine according to claim 53 comprising a further platen independently actuatable within the tube shaped platen.