Integrated Hinged Cartridge Housings for Sample Analysis

• US 20110150705A1
• Filed: 12/17/2010
• Published: 06/23/2011
• Est. Priority Date: 12/18/2009
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Cooper, Adrian, DOYLE, Kevin John, Noell, John Oakey, Withers, Mick, Wilkins, Paul
• Granted Patent: US 8,747,774 B2
• Time in Patent Office: Days
• US Class Current: 422/82.02
• CPC Class Codes: B01L 2200/04 Exchange or ejection of cartridges, containers or reservoirs
• 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 2300/123 Flexible; Elastomeric
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 3/50 Containers for the purpose of retaining a material to be analysed, e.g. test tubes devices for taking samples of blood A61B5/15
• CPC Class Codes: B01L 3/5055 Hinged, e.g. opposable surfaces
• CPC Class Codes: Y10T 156/1051 by folding
• CPC Class Codes: Y10T 29/4998 Combined manufacture including applying or shaping of fluent material

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 comprising a first substantially rigid zone, a second substantially flexible zone, a hinge region, and at least one sensor recess containing a sensor. The housing is foldable about said hinge region to form a cartridge having a conduit over at least a portion of said 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 first substantially rigid zone, a second substantially flexible zone, a hinge region, and at least one sensor recess containing a sensor, wherein said housing is foldable about said hinge region to form a cartridge having a conduit over at least a portion of said sensor.

2. The cartridge housing of claim 1, wherein the cartridge has an unfolded position comprising a top portion and a bottom portion, and wherein the top portion and the bottom portion are separated by the hinge region.

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 folding of the housing about the hinge region.

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

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

6. A cartridge housing of claim 1, wherein said sensor recess is in a portion of said substantially flexible zone.

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

8. A cartridge housing of claim 1, wherein said sensor recess is in a portion of said substantially rigid zone.

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

11. A cartridge housing of claim 1, wherein said substantially rigid zone comprises PETG.

12. A cartridge housing of claim 1, wherein the substantially rigid zone comprises a material selected from the group consisting of ABS, polycarbonate, polystyrene, Topaz, acrylic polymers, PMMA and combinations thereof.

13. A cartridge housing of claim 1, wherein the substantially flexible zone comprises a thermoplastic elastomer.

14. 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 ASTM D638 of from 0.1 to 6 MPa.

15. A cartridge housing of claim 1, wherein the hinge region comprises portions of the substantially rigid zone and of the substantially flexible zone.

16. A cartridge housing of claim 1, wherein the hinge region has a hinge region axis and the sensor recess has a sensor recess axis, and wherein the hinge region axis is substantially parallel to the sensor recess axis.

17. A cartridge housing of claim 1, wherein the hinge region has a hinge region axis and the sensor recess has a sensor recess axis, and wherein the hinge region axis is substantially orthogonal to the sensor recess axis.

18. A cartridge housing of claim 1, wherein said housing comprises one or more mating elements on either or both sides of said hinge region, and wherein folding engages said mating elements in a secure manner to form said conduit.

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

20. A cartridge housing of claim 18, wherein the mating elements are secured with glue to form said conduit.

21. A cartridge housing of claim 1, wherein said housing comprises one or more welding regions on either or both sides of said hinge region, and wherein folding engages said welding regions so that they are configured such that they may be welded together in a secure manner to form said conduit.

22. A cartridge housing of claim 21, wherein said welding is selected from the group consisting of ultrasonic welding, laser welding and thermal welding.

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

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

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

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

27. A cartridge housing of claim 1, wherein a portion of said substantially rigid zone forms at least one of the walls of said conduit.

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

29. A cartridge housing of claim 1, wherein a portion of said substantially flexible zone forms a gasket defining the geometry and dimensions of said conduit.

30. A cartridge housing of claim 1, wherein a portion of said substantially flexible zone forms a gasket defining the position of said conduit, and wherein said gasket further comprises a compliant sealing ridge.

31. A cartridge housing of claim 1, wherein a portion of said substantially flexible zone forms an ergonomic thumb well.

32. A cartridge housing of claim 1, wherein said conduit is liquid-tight.

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

34. A cartridge housing of claim 1, wherein said 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.

35. A cartridge housing of claim 1, wherein said conduit further comprises a sealable sample entry port wherein a portion of said substantially rigid zone forms a sealing member and a portion of said substantially flexible zone forms a perimeter seal around said sample entry port, wherein said sealing member is engageable with said perimeter seal.

36. A cartridge housing of claim 1, wherein said conduit further comprises a sealable sample entry port and a vent hole.

37. A cartridge housing of claim 1, wherein said sensor recess contains a sensor array comprising a plurality of sensors for a plurality of analytes.

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

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

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

41. A cartridge housing of claim 1, wherein said 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.

42. A cartridge housing of claim 1, wherein the cartridge housing is in an open position.

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

44. A method of making a test cartridge for measuring an analyte or property of a liquid sample, the method comprising the steps of:

(a) molding a housing comprising a first substantially rigid zone and a second substantially flexible zone, wherein said housing has a hinge region and said substantially flexible zone has at least one sensor recess;

(b) inserting a sensor into said sensor recess;

(c) folding said housing at said hinge region; and

(d) sealing said housing in a closed position, wherein said sealing forms the cartridge, and the cartridge comprises a conduit over at least a portion of said sensor.

45. The method of claim 44, wherein the molded comprises injection molding.

46. The method of claim 44, wherein the process further comprises the step of molding a desiccant plastic material into the housing.

47. The method of claim 44, wherein the substantially rigid zone is formed in a first injection molding step and the substantially flexible zone is formed in a second injection molding step.

48. The method of claim 44, wherein at least one of the substantially rigid zone or the substantially flexible zone is molded as a single contiguous zone.

49. The method of claim 44, wherein the substantially flexible zone is molded as a plurality of non-contiguous flexible zones.

50. The method of claim 44, wherein said sensor recess is molded in a portion of said substantially flexible zone.

51. The method of claim 44, wherein said sensor recess is in a portion of said substantially rigid zone.

52. The method of claim 44, wherein said substantially rigid zone is molded from PETG.

53. The method of claim 44, wherein the substantially rigid zone is molded from a material selected from the group consisting of ABS, polycarbonate, polystyrene, Topaz, acrylic polymers, PMMA and combinations thereof.

54. The method of claim 44, wherein the substantially flexible zone is molded from a thermoplastic elastomer.

55. The method of claim 44, wherein the substantially flexible zone is molded from an injection moldable thermoplastic elastomer having modulus of elasticity at 100% strain as determined by ASTM D638 of from 0.1 to 6 MPa.

56. The method of claim 44, wherein said housing comprises one or more mating elements on either or both sides of said hinge region, and wherein folding engages said mating elements in a secure manner to form said conduit.

57. The method of claim 56, wherein opposing mating elements may be mated by hot-staking, cold-staking or by a snap closure.

58. The method of claim 56, wherein the mating elements are secured with glue to form said conduit.

59. The method of claim 44, wherein said housing comprises one or more welding regions on either or both sides of said hinge region, and wherein folding engages said welding regions so that they are configured such that they may be welded together in a secure manner to form said conduit.

60. The method of claim 59, wherein said welding is selected from the group consisting of ultrasonic welding, laser welding and thermal welding.

61. The method of claim 44, further comprising inserting a pouch containing a fluid into the housing, before step (c).

62. The method of claim 44, wherein said sensor recess comprises a plurality of recesses each of which contains at least one sensor.

63. A sample analysis cartridge, comprising:

(a) a housing having a sample entry orifice for receiving a fluid sample;

(b) a holding chamber disposed between the sample entry orifice and a capillary stop for forming a metered sample therebetween, wherein the capillary stop is formed of opposing housing portions and a substantially flexible portion disposed therebetween to seal said opposing housing portions in a liquid-tight manner; and

(c) a conduit disposed between the capillary stop and a sensor and being configured to deliver the metered sample from the capillary stop to the sensor.

64. The cartridge of claim 63, wherein the holding chamber has a ramped region in which the lateral cross-sectional area decreases in a distal direction from the sample entry orifice to the capillary stop.

65. The cartridge of claim 63, wherein the ramped region extends over at least 50 percent of the length of the holding chamber.

66. The cartridge of claim 65, wherein the ramped region comprises a ramp element on at least one of the top surface or the bottom surface of the holding chamber.

67. The cartridge of claim 66, wherein the side walls of the holding chamber narrow at the capillary stop.

68. The cartridge of claim 63, wherein housing comprises a top housing portion defining a top portion of the holding chamber, a bottom housing portion defining a bottom portion of the holding chamber, and wherein the top portion and the bottom portion are sealed together with one or more mating elements to form the holding chamber.

69. The cartridge of claim 68, wherein at least one of the top portion or the bottom portion include a sealing ridge for sealing opposing portions of the holding chamber.

70. A cartridge capable of measuring an analyte or property of a liquid sample, comprising:

(a) a sample entry orifice for receiving the liquid sample;

(b) a top housing portion defining a top portion of a conduit;

(c) a bottom housing portion defining a bottom portion of the conduit, wherein the top portion and the bottom portion are sealed together with one or more mating elements to form the conduit, wherein at least one of the top portion or the bottom portion includes a flexible sealing ridge for sealing opposing portions of the conduit; and

(d) a sensor for detecting the analyte or property of the liquid sample.

71. The cartridge of claim 70, wherein the top portion and bottom portion are connected to one another by a hinge region.

72. The cartridge of claim 70, wherein said one or more mating elements are matable by hot staking or cold staking.

73. The cartridge of claim 70, wherein said one or more mating elements are snap closures.

74. The cartridge of claim 70, wherein said mating elements comprise one or more welded regions.

75. A molded housing, comprising a substantially rigid zone, a substantially flexible zone, and a hinge, wherein the housing is foldable at the hinge to form a fluid channel, and wherein at least a portion of the substantially flexible zone forms a channel seal.

76. The housing of claim 75, wherein the housing is a two-shot molded housing.

77. The housing of claim 75, wherein at least a portion of the substantially rigid zone is optically transparent.

78. The housing of claim 75, wherein at least a portion of the fluid channel is a cuvette.

79. The housing of claim 75, wherein said fluid channel has reagents for an optical assay.

80. The housing of claim 75, further comprising a sensor.

81. The housing of claim 75, wherein the channel seal is a liquid-tight seal.

82. The housing of claim 75, wherein the channel seal is an air-tight seal.

83. A cartridge, comprising a molded housing comprising a substantially rigid zone, a substantially flexible zone, and a hinge, wherein the housing is folded about the hinge to form a fluid channel, and wherein at least a portion of the substantially flexible zone forms a channel seal.

84. The cartridge of claim 83, wherein the molded housing is formed in a two-shot injection molding process.

85. The cartridge of claim 83, wherein at least a portion of the substantially rigid zone is optically transparent.

86. The cartridge of claim 83, wherein at least a portion of the fluid channel is a cuvette.

87. The cartridge of claim 83, wherein said fluid channel has reagents for an optical assay.

88. The cartridge of claim 83, wherein the housing further comprises a sensor.

89. The cartridge of claim 83, wherein the channel seal is a liquid-tight seal.

90. The cartridge of claim 83, wherein the channel seal is an air-tight seal.

91. A method for forming a cartridge, comprising:

(a) providing a molded housing comprising a substantially rigid zone, a substantially flexible zone, and a hinge; and

(b) folding the housing at the hinge to form a fluid channel, wherein at least a portion of the substantially flexible zone forms a channel seal.

92. The method of claim 91, further comprising the step of forming the molded housing in a two-shot injection molding process.

93. The method of claim 91, wherein at least a portion of the substantially rigid zone is optically transparent.

94. The method of claim 91, wherein at least a portion of the fluid channel is a cuvette.

95. The method of claim 91, wherein said fluid channel has reagents for an optical assay.

96. The method of claim 91, wherein the housing further comprises a sensor.

97. The method of claim 91, wherein the channel seal is a liquid-tight seal.

98. The method of claim 91, wherein the channel seal is an air-tight seal.