Integrated cartridge housings for sample analysis

• US 9,592,507 B2
• Filed: 06/22/2012
• Issued: 03/14/2017
• Est. Priority Date: 06/22/2012
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Doyle, Kevin John, Wilkins, Paul, Withers, Mick, Cooper, Adrian, Noell, John Oakey
• Primary Examiner(s): Jarrett, Lore
• Application Number:
  US13/530,501
• Publication Number:
  US 20130343955A1
• Time in Patent Office: 1,726 Days
• US Class Current: 1/1
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• CPC Class Codes: B01L 2200/0689 Sealing
• 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 2300/043 Hinged closures
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• 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 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 3/5055 Hinged, e.g. opposable surfaces
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• CPC Class Codes: Y10T 29/49826 Assembling or joining
• CPC Class Codes: Y10T 428/13 Hollow or container type article [e.g., tube, vase, etc.]

Abstract

The invention relates to a cartridge housing for forming a cartridge capable of measuring an analyte or property of a liquid sample. The housing including a top portion having a first substantially rigid zone and a substantially flexible zone, a bottom portion separate from the top portion including a second substantially rigid zone, and at least one sensor recess containing a sensor. The top portion and the bottom portion are bonded to form the cartridge having a conduit over at least a portion of the sensor. The invention also relates to methods for forming such cartridges and to various features of such cartridges.

Claims

1. A cartridge housing for forming a cartridge capable of measuring an analyte or property of a liquid sample, the housing comprising:

a top portion including;

a first substantially rigid zone; and

a first portion of a substantially flexible zone;

a bottom portion separate from the top portion including;

a second substantially rigid zone; and

a second portion of the substantially flexible zone; and

at least one sensor recess containing a sensor,

wherein the top portion and the bottom portion are bonded to form the cartridge having a conduit over at least a portion of the sensor;

wherein the substantially flexible zone comprises a thermoplastic elastomer; and

wherein a textured structure on the top portion of the housing is formed by the first portion of the substantially flexible zone, and a textured structure on the bottom portion of the housing is formed by the second portion of the substantially flexible zone.

2. The cartridge housing of claim 1, wherein the at least one sensor recess is formed in the bottom portion.

3. The cartridge housing of claim 2, wherein the top portion forms a top portion of the conduit and the bottom portion forms a bottom portion of the conduit, and wherein the conduit is formed upon abutting the top portion with the bottom portion.

4. A cartridge housing of claim 1, wherein at least one of the first substantially rigid zone and the second substantially rigid zone is a single contiguous zone.

5. A cartridge housing of claim 1, wherein at least one of the first substantially rigid zone, the second substantially rigid zone, or the substantially flexible zone comprises a plurality of non-contiguous zones.

6. A cartridge housing of claim 1, wherein the at least one sensor recess is in a third portion of the substantially flexible zone.

7. A cartridge housing of claim 1, wherein the at least one sensor recess is in a third portion of the substantially flexible zone forming a liquid-tight seal around a perimeter of the sensor.

8. A cartridge housing of claim 1, further comprising a disposable membrane, a region around the disposable membrane, a sample entry port, and a closeable sealing member configured to close the sample entry port, wherein the disposable membrane is in a third portion of the substantially flexible zone, the region around the disposable membrane is in a fourth portion of the substantially flexible zone, and the closeable sealing member is in a fifth portion of the substantially flexible zone, and the at least one sensor recess in a portion of the second substantially rigid zone.

9. A cartridge housing of claim 1, wherein the at least one sensor recess is in a portion of the second substantially rigid zone, and the sensor is secured to the sensor recess by a liquid-tight seal formed by an adhesive tape.

10. A cartridge housing of claim 1, wherein the at least one sensor recess is in a portion of the second substantially rigid zone, the sensor is secured by a liquid-tight seal, and wherein the seal is formed by at least one of glue, a perimeter of formable resin, or dielectric grease.

11. A cartridge housing of claim 1, wherein the first substantially rigid zone and the second substantially rigid zone comprise polyethylene terepthalate glycol (PETG).

12. A cartridge housing of claim 1, wherein the first substantially rigid zone and the second substantially rigid zone comprise a material selected from the group consisting of acrylonitrile butadiene styrene (ABS), polycarbonate, polystyrene, Topaz, acrylic polymers, polymethylmethacrylate (PMMA) and combinations thereof.

13. A cartridge housing of claim 1, wherein the substantially flexible zone is molded from an injection moldable thermoplastic elastomer having modulus of elasticity at 100% strain as determined by American Society for Testing and Materials (ASTM) D638 of from 0.1 to 6 MPa.

14. A cartridge housing of claim 1, further comprising a displaceable membrane, wherein the displaceable membrane comprises a third portion of the substantially flexible zone.

15. A cartridge housing of claim 1, further comprising a thumb well, wherein the thumb well comprises the textured structure on the top portion of the housing formed by the first portion of the substantially flexible zone.

16. A cartridge housing of claim 1, further comprising a flexible zone and a recessed region, wherein the flexible zone is positioned over the recessed region, and the flexible zone comprises a third portion of the substantially flexible zone.

17. A cartridge housing of claim 1, wherein the housing further comprises one or more mating elements on either or both of the top portion and the bottom portion, and wherein abutting the top portion with the bottom portion engages the one or more mating elements in a secure manner to form the conduit.

18. A cartridge housing of claim 17, wherein opposing mating elements of the one or more mating elements are matable by hot staking, cold staking or by a snap closure.

19. A cartridge housing of claim 17, wherein the one or more mating elements are secured with glue to form the conduit.

20. A cartridge housing of claim 1, wherein the housing comprises one or more welding regions on either or both of the top portion and the bottom portion, and wherein abutting the top portion with the bottom portion engages the one or more welding regions so that they are configured such that they may be welded together in a secure manner to form the conduit.

21. A cartridge housing of claim 20, wherein the welding of the one or more welding regions is selected from the group consisting of ultrasonic welding, laser welding and thermal welding.

22. A cartridge housing of claim 1, further comprising a pouch containing a fluid, wherein the pouch is in fluid communication with the conduit.

23. A cartridge housing of claim 1, further comprising a pneumatic pump connected to the conduit.

24. A cartridge housing of claim 23, wherein the pump comprises a displaceable membrane formed by a third portion of the substantially flexible zone.

25. A cartridge housing of claim 1, wherein a gasket is situated between the top portion and the bottom portion to form the cartridge.

26. A cartridge housing of claim 25, wherein the gasket bonds the top portion and the bottom portion together, and defines and seals the conduit.

27. A cartridge housing of claim 25, wherein the gasket covers substantially an entire area between the top portion and the bottom portion of the housing.

28. A cartridge housing of claim 27, wherein the gasket is a double-sided adhesive sheet that forms a liquid-tight seal.

29. A cartridge housing of claim 27, wherein the gasket comprises at least one of a thermoplastic elastomer (TPE), a bead of glue, a perimeter of formable resin, dielectric grease, or a peripheral ridge comprising portions of the substantially flexible zone.

30. A cartridge housing of claim 1, wherein a third portion of the substantially flexible zone forms at least two of the walls of the conduit;

and

a portion of the second substantially rigid zone forms at least one of the walls of the conduit.

31. A cartridge housing of claim 1, wherein a third portion of the substantially flexible zone forms a gasket defining a position of the conduit;

and

the conduit is liquid-tight and air-tight.

32. A cartridge housing of claim 1, wherein the conduit further comprises a sealable sample entry port, a sample holding chamber, a sensing region and a waste chamber.

33. A cartridge housing of claim 1, wherein the conduit further comprises a sealable sample entry port and a sample holding chamber, wherein the cross-sectional area of a portion of the sample holding chamber decreases distally with respect to the sample entry port.

34. A cartridge housing of claim 1, wherein the conduit further comprises a sealable sample entry port wherein a portion of the first substantially rigid zone forms a sealing member and a third portion of the substantially flexible zone forms a seal on the sealing member, wherein the sealing member with the seal is engageable with the sealable sample entry port to create an air-tight seal.

35. A cartridge housing of claim 1, wherein the conduit further comprises a sealable sample entry port.

36. A cartridge housing of claim 1, wherein the at least one sensor recess contains a sensor array comprising a plurality of sensors for a plurality of analytes.

37. A cartridge housing of claim 1, wherein the at least one sensor recess comprises a plurality of recesses each of which contains at least one sensor.

38. A cartridge housing of claim 1, wherein the cartridge is a single-use disposable cartridge.

39. A cartridge housing of claim 1, wherein the cartridge is a multiple-use cartridge.

40. A cartridge housing of claim 1, wherein the sensor is selected from the group consisting of electrochemical, amperometric, conductimetric, potentiometric, optical, absorbance, fluorescence, luminescence, piezoelectric, surface acoustic wave and surface plasmon resonance sensors.

41. A cartridge housing of claim 1, wherein the top portion further comprises an interior surface and the bottom portion further comprises an interior surface that is complimentary to the interior surface of the top portion;

and

the top portion and the bottom portion are bonded together to abut and attach the two complimentary interior surfaces of the top portion and the bottom portion in a closed position.

42. A cartridge, comprising the cartridge housing of claim 1, in a closed position.

43. A molded housing, comprising:

a substantially rigid zone;

a substantially flexible zone comprising a thermoplastic elastomer; and

a gasket,

wherein the housing is bonded together with the gasket to form a fluid channel,

wherein at least a portion of the gasket forms a channel seal, and

wherein textured structures on a top and bottom of the housing are formed by first and second portions of the substantially flexible zone.

44. The housing of claim 43, wherein the housing is a two-shot molded housing, a deformable membrane within the housing is formed by a third portion of the substantially flexible zone, and a fourth portion of the substantially flexible zone is positioned over a recessed region of the housing.

45. The housing of claim 43, wherein at least a portion of the substantially rigid zone is optically transparent.

46. The housing of claim 43, wherein at least a portion of the fluid channel is a cuvette.

47. The housing of claim 43, wherein the fluid channel has reagents for an optical assay.

48. The housing of claim 43, further comprising a sensor.

49. The housing of claim 43, wherein the channel seal is a liquid-tight seal.

50. The housing of claim 43, wherein the channel seal is an air-tight seal.