FLUID-CONTAINING POUCHES WITH REDUCED GAS EXCHANGE AND METHODS FOR MAKING SAME

• US 20100068097A1
• Filed: 09/15/2008
• Published: 03/18/2010
• Est. Priority Date: 09/15/2008
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Original Assignee: i STAT Corporation (Abbott Laboratories)
• Inventors: Poirier, Philippe, Dicke, Bill, ADE, Rhonda, Breeze, Steven R.
• Granted Patent: US 8,216,529 B2
• Time in Patent Office: Days
• US Class Current: 422/68.100
• CPC Class Codes: B01L 2200/0689 Sealing
• 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 3/52 Containers specially adapted for storing or dispensing a reagent B01L3/02 takes precedence; containers for medical or pharmaceutical purposes A61J1/00; containers in general B65D; storing or dispensing test elements G01N33/4875; automated reagent dispensing G01N35/1002
• CPC Class Codes: B01L 9/00 Supporting devices; Holding devices
• CPC Class Codes: B23K 2103/50 Inorganic material, e.g. metals, not provided for in B23K2103/02 – B23K2103/26
• CPC Class Codes: B23K 26/206 Laser sealing
• CPC Class Codes: B23K 26/244 Overlap seam welding
• CPC Class Codes: B23K 26/32 taking account of the properties of the material involved
• CPC Class Codes: B29C 59/026 of layered or coated substantially flat surfaces
• CPC Class Codes: B29C 65/081 having a component of vibration not perpendicular to the welding surface
• CPC Class Codes: B29C 65/16 Laser beams
• CPC Class Codes: B29C 65/18 using heated tools
• CPC Class Codes: B29C 65/224 being a resistive ribbon, a resistive band or a resistive strip
• CPC Class Codes: B29C 65/8246 Pressure tests, e.g. hydrostatic pressure tests
• CPC Class Codes: B29C 65/8253 by the use of waves or particle radiation, e.g. visual examination, scanning electron microscopy, or X-rays B29C65/8292 takes precedence
• CPC Class Codes: B29C 66/112 Single lapped joints
• CPC Class Codes: B29C 66/1122 Single lap to lap joints, i.e. overlap joints B29C66/45, B29C66/472, B29C66/52272 take precedence
• CPC Class Codes: B29C 66/131 Single flanged joints, i.e. one of the parts to be joined being rigid and flanged in the joint area
• CPC Class Codes: B29C 66/24244 forming a rectangle
• CPC Class Codes: B29C 66/24245 : forming a square
• CPC Class Codes: B29C 66/346 : Making joints having variable thicknesses in the joint area, e.g. by using jaws having an adapted configuration
• CPC Class Codes: B29C 66/43 : Joining a relatively small portion of the surface of said articles B29C66/45 takes precedence
• CPC Class Codes: B29C 66/53461 : joining substantially flat covers and/or substantially flat bottoms to open ends of container bodies
• CPC Class Codes: B29C 66/71 : characterised by the composition of the plastics material of the parts to be joined welding bar compositions B29C65/125
• CPC Class Codes: B29C 66/72321 : consisting of metals or their alloys
• CPC Class Codes: B29C 66/72341 : for gases
• CPC Class Codes: B29C 66/72343 : for liquids
• CPC Class Codes: B29C 66/81417 : being V-shaped
• CPC Class Codes: B29C 66/81435 : comprising several parallel ridges, e.g. for crimping comprising a single ridge B29C66/81427
• CPC Class Codes: B29C 66/8322 : Joining or pressing tools reciprocating along one axis
• CPC Class Codes: B29K 2001/18 : Cellulose nitrate
• CPC Class Codes: B29K 2023/06 : PE, i.e. polyethylene
• CPC Class Codes: B29K 2023/12 : PP, i.e. polypropylene
• CPC Class Codes: B29K 2027/06 : PVC, i.e. polyvinylchloride
• CPC Class Codes: B29K 2033/08 : Polymers of acrylic acid esters, e.g. PMA, i.e. polymethylacrylate
• CPC Class Codes: B29K 2075/02 : Polyureas
• CPC Class Codes: B29K 2305/00 : Use of metals, their alloys or their compounds, as reinforcement
• CPC Class Codes: B29K 2305/02 : Aluminium
• CPC Class Codes: B29K 2995/0067 : non-permeable
• CPC Class Codes: B29K 2995/0069 : non-permeable
• CPC Class Codes: B29L 2009/003 : comprising a metal layer
• CPC Class Codes: B29L 2031/712 : Containers; Packaging elements or accessories, Packages closures therefor B29L2031/56; ink or toner cartridges B29L2031/7678; squeeze tubes B29L2023/20; suitcases B29L2031/7418
• CPC Class Codes: B65D 75/30 : Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
• CPC Class Codes: Y10T 428/31573 : Next to addition polymer of ethylenically unsaturated monomer

Abstract

The invention is directed to fluid-containing pouches and to methods for forming fluid-containing pouches. In one embodiment, the invention is to a fluid-containing pouch, comprising first and second opposing sheets, and a fluid (e.g., a calibrant fluid, a reactant fluid or a wash fluid) disposed between the first and second opposing sheets. The first sheet and the second sheet have a substantially liquid and gas impermeable perimeter seal. The sheets may be sealed, for example, by one or more of heat crimping, pressure crimping, heat and pressure crimping, ultrasonic welding, metal-to-metal welding or laser welding. Fluid-containing pouches sealed according to the disclosed methods and apparatuses show substantially improvement in terms of reduced gas exchange, notably CO₂ pressurization levels.

Claims

1. A fluid-containing pouch, comprising:

first and second opposing sheets; and

a fluid disposed between the first and second opposing sheets, wherein the first sheet and the second sheet have a substantially liquid and gas impermeable perimeter seal at least a portion of which has a seal width less than about 4 mm, and wherein the pouch yields a Pouch Integrity Test Δ

pCO₂ value of less than about 10 mm Hg.

2. The fluid-containing pouch of claim 1, wherein the first sheet and the second sheet are folded in an undulating pattern having a plurality of bends.

3. The fluid-containing pouch of claim 1, wherein the first sheet includes a first foil layer and a first plastic layer, and the second sheet includes a second foil layer and a second plastic layer.

4. The fluid-containing pouch of claim 3, further comprising:

an interior plastic seal bead disposed at an interior edge of the perimeter seal.

5. The fluid-containing pouch of claim 3, wherein the first sheet includes a first foil layer and a first plastic layer, and the second sheet includes a second foil layer and a second plastic layer, and wherein the perimeter seal comprises a third plastic layer disposed between the first and second foils and having an average thickness less than the combined thickness of the first and second plastic layers.

6. The fluid-containing pouch of claim 5, wherein the third plastic layer has an average thickness that is at least about 25% less than the combined thickness of the first and second plastic layers.

7. The fluid-containing pouch of claim 5, wherein the third plastic layer has an average thickness that is at least about 50% less than the combined thickness of the first and second plastic layers.

8. The fluid-containing pouch of claim 5, wherein the first and second foil layers have a thickness in the range of from about 0.01 to about 2.0 mm.

9. The fluid-containing pouch of claim 5, wherein the first and second plastic layers have a thickness in the range of from about 0.005 to about 0.5 mm.

10. The fluid-containing pouch of claim 5, wherein the first and second plastic layers comprise plastic selected from the group consisting of Primacor, polyvinyl chloride, polytethylene and lacquer based on nitrocellulose, urea and acrylic resins.

11. The fluid-containing pouch of claim 5, wherein the first and second plastic layers are substantially rectangular and have respective areas in the range of from about 0.5 cm² to about 20 cm².

12. The fluid-containing pouch of claim 5, further comprising a plastic bead along at least a portion of the perimeter seal.

13. The fluid-containing pouch of claim 5, wherein the perimeter seal is formed by applying heat in the range of from about 200°

C. to about 500°

C.

14. The fluid-containing pouch of claim 5, wherein the perimeter seal is formed by applying pressure in the range of from about 34.5 MN/m² to about 62.1 MN/m².

15. The fluid-containing pouch of claim 5, wherein the perimeter seal has a perimeter width of from about 1 mm to about 2 cm.

16. The fluid-containing pouch of claim 5, wherein the perimeter seal has a perimeter length of from about 1 cm to about 20 cm.

17. The fluid-containing pouch of claim 1, wherein the first sheet includes a first foil layer and a first lacquer layer, the second sheet includes a second foil layer and a second lacquer layer, and the first and second foil layers are fused to one another at the perimeter seal.

18. The fluid-containing pouch of claim 1, wherein the fluid is a calibrant fluid containing a known concentration of one or more analytes.

19. The fluid-containing pouch of claim 1, wherein the fluid is a reactant fluid.

20. The fluid-containing pouch of claim 1, wherein the fluid is a wash fluid.

21. The fluid-containing pouch of claim 1, wherein the pouch has a burst strength standard deviation of less than 12%.

22. The fluid-containing pouch of claim 1, wherein the first sheet and the second sheet, respectively, are opposing folded portions of a single plastic-lined foil.

23. The fluid-containing pouch of claim 1, wherein the first sheet and the second sheet, respectively, are two separate pieces of foil.

24. The fluid-containing pouch of claim 1, wherein the first sheet and the second sheet comprise a metallic foil selected from the group consisting of aluminum foil, copper foil and brass foil.

25. The fluid-containing pouch of claim 1, wherein the first sheet and the second sheet comprise foil with a thickness in the range of from about 0.01 to about 2.0 mm.

26. The fluid-containing pouch of claim 1, wherein the pouch has a pouch volume of from about 5 μ

L to about 5 mL.

27. The fluid-containing pouch of claim 26, wherein the pouch contains a liquid having a liquid volume of from about 5 μ

L to about 5 mL.

28. The fluid-containing pouch of claim 27, wherein the liquid volume is from about 50% to about 95%, based on the total pouch volume.

29. The fluid-containing pouch of claim 26, wherein the pouch contains a gas volume of about 5 μ

L to about 5 mL.

30. The fluid-containing pouch of claim 29, wherein the gas volume is from about 5% to about 50%, based on the total pouch volume.

31. The fluid-containing pouch of claim 29, wherein the gas in the gas phase comprises a calibrant gas having a known concentration or partial pressure of one or more gases.

32. The fluid-containing pouch of claim 29, wherein the gas in the gas phase is ambient air.

33. The fluid-containing pouch of claim 1, wherein the perimeter seal includes one or more crimped regions.

34. The fluid-containing pouch of claim 33, wherein the one or more crimped regions comprise multiple concentric crimping rings.

35. The fluid-containing pouch of claim 1, wherein the pouch is in a cartridge containing a sensor.

36. The fluid-containing pouch of claim 1, wherein the pouch contains a calibrant fluid used to calibrate a sensor.

37. The fluid-containing pouch of claim 1, wherein the pouch contains a calibrant fluid with a predetermined partial pressure of carbon dioxide, the calibrant fluid being used to calibrate a sensor for the partial pressure of carbon dioxide.

38. The fluid-containing pouch of claim 1, wherein the pouch is in a single-use cartridge containing at least one sensor, and wherein the cartridge is used in conjunction with a reader to measure an analyte is a sample.

39. A fluid-containing pouch, comprising:

first and second opposing sheets; and

a fluid disposed between the first and second opposing sheets, wherein the pouch has a burst strength with a standard deviation of less than 12%.

40. A method for forming a fluid-containing pouch, comprising the steps of:

(a) depositing a fluid on a first sheet;

(b) positioning a second sheet opposite the first sheet; and

(c) sealing the opposing first and second sheets to one another and forming a sealed region having the fluid contained therebetween, wherein the sealed region is substantially liquid and gas impermeable.

41. The method of claim 40, wherein the pouch yields a Pouch Integrity Test Δ

pCO₂ value of less than 10 mm Hg.

42. The method of claim 40, wherein the sealed region comprises a sealed perimeter region.

43. The method of claim 40, wherein the sealing comprises applying heat and pressure to the first sheet and second sheets.

44. The method of claim 40, wherein the sealing comprises ultra-sonic welding.

45. The method of claim 40, wherein the sealing comprises laser welding.

46. The method of claim 40, wherein the first sheet and the second sheet are folded in a undulating pattern having a plurality of bends.

47. The method of claim 40, wherein the first sheet includes a first foil layer and a first plastic layer, and the second sheet includes a second foil layer and a second plastic layer, and wherein the step of sealing comprises melting the first plastic layer on the first sheet with the second plastic layer on the second sheet such that an interior plastic seal bead is formed, and wherein the interior plastic seal bead substantially prevents the calibrant liquid from contacting either of or both of the first and second foil layers.

48. The method of claim 40, wherein the first sheet includes a first foil layer and a first plastic layer, and the second sheet includes a second foil layer and a second plastic layer, and wherein the perimeter seal comprises a third plastic layer disposed between the first and second foils and having an average thickness less than the combined thickness of the first and second plastic layers.

49. The method of claim 40, wherein the third plastic layer has an average thickness that is at least about 50% less than the combined thickness of the first and second plastic layers.

50. The method of claim 40, wherein the third plastic layer has an average thickness that is at least about 25% less than the combined thickness of the first and second plastic layers.

51. The method of claim 40, wherein the first sheet includes a first foil layer and a first lacquer layer, and the second sheet includes a second foil layer and a second lacquer layer, and wherein the step of sealing comprises ultrasonic welding the first foil layer to the second foil layer.

52. The method of claim 40, wherein the fluid is a calibrant fluid.

53. The method of claim 40, wherein the fluid is a reactant fluid.

54. The method of claim 40, wherein the fluid is a wash fluid.

55. The method of claim 40, wherein the pouch has a burst strength standard deviation of less than 12%.

56. The method of claim 40, wherein the process further comprises forming a cavity in the first sheet, and depositing the fluid in the cavity.

57. The fluid-containing pouch formed by the method of claim 40.

58. A substantially gas-tight seal formed with plastic-lined foil, comprising:

two portions of plastic-lined foil with plastic faces abutted where adjacent portions are sealed together to isolate a first phase from a second phase, where said seal is formed by applying sufficient heat and pressure to melt the plastic and form a plastic seal, whereby the heat and pressure are applied by a crimping element yielding one or more regions of the seal where the average thickness of plastic in the crimped region is less than the initial combined thickness of the two plastic linings, and whereby gas transport between said first phase and said second phase through said plastic seal is substantially less than a seal where plastic is not crimped during sealing.

59. A substantially gas-tight plastic-lined foil pouch with a perimeter seal, comprising two portions of plastic-lined foil with plastic faces abutted and sealed together to form an enclosure containing a liquid phase and a gas phase, where said perimeter seal is formed by applying sufficient heat and pressure to melt the plastic and form a plastic perimeter layer, where the pressure is applied by a crimping element yielding one or more regions of the perimeter seal where the average thickness of plastic in the perimeter seal in the crimped regions is substantially less than the initial combined thickness of the two plastic linings.

60. A method of forming a substantially gas tight seal in a plastic-lined foil pouch, comprising:

(a) forming a pocket in a first plastic-lined foil, applying a portion of liquid into the pocket;

(b) covering the pocket with a second plastic-lined foil with the plastic faces abutted; and

(c) sealing said first and second plastic-lined foils together to form a perimeter seal, where said perimeter seal is formed by applying sufficient heat and pressure to melt the plastic and form a plastic perimeter layer, where the pressure is applied by a crimping element yielding one or more regions of the perimeter seal where the average thickness of plastic in the crimped regions is substantially less than the combined thickness of the two plastic linings, said seal forming a substantially gas tight pouch containing a liquid phase and a gas phase.

61. The method of claim 60, performed with the foil on a reel.

62. The method of claim 60, wherein the pressure is applied with a jig that crimps the foil.

63. The method of claim 60, wherein the heat and pressure is applied with ultrasonic welding.

64. A method of forming a substantially gas-tight plastic-lined foil pouch with a perimeter seal, comprising:

(a) a first step where two portions of plastic-lined foil with the plastic faces abutted are sealed together to form an enclosure with a perimeter seal containing a liquid phase and a gas phase, where said perimeter seal is formed by applying sufficient heat to melt the plastic and sufficient pressure to form a contiguous plastic perimeter seal, and

(b) a second step where said perimeter seal is crimped to yield one or more regions of the perimeter seal where the average thickness of plastic in the crimped regions is substantially less than the combined thickness of the two plastic linings.

65. A substantially gas-tight seal formed with plastic-lined foil, comprising:

two portions of plastic-lined foil with the plastic faces abutted where adjacent portions are sealed together to isolate a first phase from a second phase, where said seal is formed by applying sufficient ultrasonic welding to melt the plastic and form a plastic seal, whereby the ultrasonic weld yields one or more regions of the plastic seal where the average thickness of plastic in the seal region is substantially less than the initial combined thickness of the two plastic linings, and whereby gas transport between said first phase and said second phase through said plastic seal is substantially less than a seal where the thickness of plastic is substantially that of the combined thickness of two plastic linings.

66. A substantially gas-tight plastic-lined foil pouch with a perimeter seal, comprising two portions of plastic-lined foil with the plastic faces abutted and sealed together to form an enclosure containing a liquid phase and a gas phase, where said perimeter seal is formed by applying an ultrasonic weld to melt the plastic and form a contiguous plastic perimeter layer, and force a portion of plastic from the seal region into at least a portion of the perimeter of the enclosure, whereby the average thickness of plastic in the perimeter seal is less than the initial combined thickness of the two plastic linings.

67. A method of forming a substantially gas tight seal in a plastic-lined foil pouch comprising:

(a) forming a pocket in a first plastic-lined foil;

(b) applying a portion of liquid into the pocket;

(c) covering the pocket with a second plastic-lined foil with the plastic faces abutted; and

(d) sealing said first and second plastic-lined foils together to form a perimeter seal, where said perimeter seal is formed by applying an ultrasonic weld to melt the plastic and force a portion of plastic from the seal region into the pocket, said seal forming a substantially gas tight pocket containing a liquid phase and a gas phase, whereby the average thickness of plastic in the perimeter seal is substantially less than the combined thickness of the two plastic linings.

68. A substantially gas-tight seal formed with plastic-lined foil, comprising:

two portions of plastic-lined foil with the plastic faces abutted where adjacent portions are sealed together to isolate a first phase from a second phase, where said seal is formed by applying sufficient welding energy to substantially remove plastic from the seal region and melt the foil and form a metal-to-metal seal in said seal region.

69. The seal of claim 68, wherein said welding energy is provided by ultrasonic energy or laser energy.

70. A substantially gas-tight foil pouch with an inner plastic perimeter seal and an outer metal-to-metal seal, comprising:

two portions of foil with a plastic lining on predetermined regions of the foil where the regions and plastic faces are aligned, abutted and sealed together to form an enclosure, bounded by an inner plastic perimeter seal, containing a liquid phase and a gas phase, and where a surrounding portion of the two portions of the foil are laser welded together forming an outer metal-to-metal seal.

71. A substantially gas-tight pouch, comprising:

an inner sealed plastic enclosure containing a liquid phase and a gas phase, and an outer sealed foil enclosure where two portions of foil are laser welded together to form an outer metal-to-metal seal enclosing said plastic enclosure.