Integrated Cartridge Housings For Sample Analysis

• US 20130343955A1
• Filed: 06/22/2012
• Published: 12/26/2013
• 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
• Granted Patent: US 9,592,507 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 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 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,

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.

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, the second 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 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 sensor recess is in a portion of the substantially flexible zone.

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

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

9. A cartridge housing of claim 1, wherein the 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 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 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 American Society for Testing and Materials (ASTM) D638 of from 0.1 to 6 MPa.

15. A cartridge housing of claim 1, further comprising a displaceable membrane, wherein the displaceable membrane comprises portions of the substantially flexible zone.

16. A cartridge housing of claim 1, further comprising a thumb well, wherein the thumb well comprises portions of the substantially flexible zone.

17. 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 portions of the substantially flexible zone.

18. 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 mating elements in a secure manner to form the 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 the conduit.

21. 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 welding regions so that they are configured such that they may be welded together in a secure manner to form the conduit.

22. A cartridge housing of claim 21, wherein the 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 the pouch is in fluid communication with the conduit.

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

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

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

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

28. A cartridge housing of claim 26, wherein the gasket covers substantially an entire area between the top portion and the bottom portion of the housing.

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

30. A cartridge housing of claim 28, 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.

31. A cartridge housing of claim 1, wherein a 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.

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

and

the conduit is liquid-tight and air-tight.

33. 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.

34. 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.

35. 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 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.

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

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

38. A cartridge housing of claim 1, wherein the 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 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.

42. 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.

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;

(i) a top portion including a first substantially rigid zone and a substantially flexible zone, and (ii) a bottom portion including a second substantially rigid zone, wherein the second substantially rigid zone comprises at least one sensor recess;

(b) inserting a sensor into the sensor recess;

(c) abutting the top portion with the bottom portion; and

(d) sealing the housing in a closed position, wherein the sealing forms the cartridge, and the cartridge comprises a conduit over at least a portion of the 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 first 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 first substantially rigid zone, the second 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, further comprising molding the bottom portion to include a second substantially flexible zone, wherein the sensor recess is molded in a portion of the second substantially flexible zone.

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

52. The method of claim 44, wherein the first substantially rigid zone and the second substantially rigid zone are molded from polyethylene terepthalate glycol (PETG).

53. The method of claim 44, wherein the first substantially rigid zone and the second substantially rigid zone are molded from a material selected from the group consisting of acrylonitrile butadiene styrene (ABS), polycarbonate, polystyrene, Topaz, acrylic polymers, polymethylmethacrylate (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 American Society for Testing and Materials (ASTM) D638 of from 0.1 to 6 MPa.

56. The method of claim 44, wherein the housing 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 mating elements in a secure manner to form the 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 one or more mating elements are secured with glue to form the conduit.

59. The method of claim 44, 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 welding regions so that they are configured such that they may be welded together in a secure manner to form the conduit.

60. The method of claim 59, wherein the 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 the sensor recess comprises a plurality of recesses each of which contains at least one sensor.

63. The method of claim 44, further comprising inserting a gasket between the top portion and the second portion before the step (c).

64. The method of claim 63, wherein the gasket covers substantially an entire area between the top portion and the bottom portion of the housing.

65. The method of claim 64, wherein the gasket is a double-sided adhesive sheet that forms a liquid-tight seal.

66. A sample analysis cartridge, comprising:

(a) a housing having separate opposing housing portions comprising;

(i) a top portion including a first substantially rigid zone and a substantially flexible zone, and (ii) a bottom portion including a second substantially rigid zone;

(b) a sample entry orifice for receiving a fluid sample;

(c) 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 the opposing housing portions and the substantially flexible portion disposed therebetween to seal the opposing housing portions in a liquid-tight manner; and

(d) 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; and

(e) a gasket configured to bond at least a portion of the top portion and a portion of the bottom portion together.

67. The cartridge of claim 66, 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.

68. The cartridge of claim 66, wherein the ramped region extends over at least 50 percent of the length of the holding chamber.

69. The cartridge of claim 68, wherein the ramped region comprises a ramp element on at least one of the top surface or the bottom surface of the holding chamber.

70. The cartridge of claim 69, wherein the side walls of the holding chamber narrow at the capillary stop.

71. The cartridge of claim 66, wherein the top portion of the housing defines a top portion of the holding chamber, the bottom portion of the housing defines a bottom portion of the holding chamber, and wherein the top portion of the housing and the bottom portion of the housing are sealed together with one or more mating elements to form the holding chamber.

72. The cartridge of claim 71, wherein at least one of the top portion or the bottom portion include a sealing ridge for sealing opposing portions of the holding chamber.

73. 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.

74. The cartridge of claim 73, wherein the top portion and bottom portion are bonded to one another.

75. The cartridge of claim 73, wherein the one or more mating elements are matable by hot staking or cold staking.

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

77. The cartridge of claim 73, wherein the mating elements comprise one or more welded regions.

78. A molded housing, comprising:

a substantially rigid zone;

a substantially flexible zone; and

a gasket,

wherein the housing is bonded together with the gasket to form a fluid channel, and wherein at least a portion of the gasket forms a channel seal.

79. The housing of claim 78, wherein the housing is a two-shot molded housing.

80. The housing of claim 78, wherein at least a portion of the substantially rigid zone is optically transparent.

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

82. The housing of claim 78, wherein the fluid channel has reagents for an optical assay.

83. The housing of claim 78, further comprising a sensor.

84. The housing of claim 78, wherein the channel seal is a liquid-tight seal.

85. The housing of claim 78, wherein the channel seal is an air-tight seal.

86. A cartridge, comprising a molded housing comprising:

separate top and bottom portions, at least one of which comprises a substantially rigid zone and a substantially flexible zone,

wherein the portions are bonded together to form a fluid channel, and wherein at least a portion of the substantially flexible zone forms a channel seal.

87. The cartridge of claim 86, wherein the molded housing is formed in a two-shot injection molding process.

88. The cartridge of claim 86, wherein at least a portion of the substantially rigid zone is optically transparent.

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

90. The cartridge of claim 86, wherein the fluid channel has reagents for an optical assay.

91. The cartridge of claim 86, wherein the housing further comprises a sensor.

92. The cartridge of claim 86, wherein the channel seal is a liquid-tight seal.

93. The cartridge of claim 86, wherein the channel seal is an air-tight seal.

94. A method for forming a cartridge, comprising:

(a) providing a molded housing having two separate portions, at least one of which comprises a substantially rigid zone and a substantially flexible zone;

(b) providing a gasket between the two separate portions; and

(c) bonding the two portions using the gasket to form a fluid channel, wherein at least a portion of the gasket forms a channel seal.

95. The method of claim 94, further comprising the step of forming the molded housing in a two-shot injection molding process.

96. The method of claim 94, wherein at least a portion of the substantially rigid zone is optically transparent.

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

98. The method of claim 94, wherein the fluid channel has reagents for an optical assay.

99. The method of claim 94, wherein the housing further comprises a sensor.

100. The method of claim 94, wherein the channel seal is a liquid-tight seal.

101. The method of claim 94, wherein the channel seal is an air-tight seal.

102. A method for forming a cartridge, comprising:

(a) providing a molded housing comprising two separate portions, at least one of which comprises a substantially rigid zone and a substantially flexible zone; and

(b) bonding the two portions to form a fluid channel, wherein at least a portion of the substantially flexible zone forms a channel seal.