Fluid-containing pouches with reduced gas exchange and methods for making same

• US 8,449,843 B2
• Filed: 06/06/2012
• Issued: 05/28/2013
• Est. Priority Date: 09/15/2008
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Inventors: Ade, Rhonda, Breeze, Steven R., Poirier, Philippe, Dicke, Bill
• Primary Examiner(s): Jarrett, Lore
• Application Number:
  US13/489,896
• Publication Number:
  US 20120244046A1
• Time in Patent Office: 356 Days
• Field of Search: 422/547
• US Class Current: 422/547
• 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 having a substantially liquid and gas impermeable perimeter seal having a single layer metal-to-metal melted bond, wherein the first sheet includes a first foil layer and the second sheet includes a second foil layer;

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

pCO ₂ value of less than about 10 mm Hg.

2. The fluid-containing pouch of claim 1, wherein the single layer metal-to-metal melted bond is formed by laser welding, ultra-sonic welding, or metal-to-metal welding.

3. The fluid-containing pouch of claim 1, further comprising an inner sealed plastic enclosure containing the fluid.

4. The fluid-containing pouch of claim 3, wherein the inner sealed plastic enclosure comprises first and second opposing plastic layers.

5. The fluid-containing pouch of claim 4, wherein the first and second plastic layers comprise a material selected from the group consisting of Primacor, polyvinyl chloride, polytethylene and lacquer based on nitrocellulose, urea and acrylic resins.

6. The fluid-containing pouch of claim 4, 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.

7. The fluid-containing pouch of claim 1, wherein the perimeter seal has a perimeter width of about 2 mm.

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

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

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

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

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

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

14. The fluid-containing pouch of claim 13, wherein the one or more crimped regions comprise multiple concentric crimping rings.

15. A fluid-containing pouch, comprising:

first and second opposing sheets having a substantially liquid and gas impermeable perimeter seal region having a single layer metal-to-metal melted bond formed by laser welding, 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

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

pCO ₂ value of less than about 10 mm Hg.

16. The fluid-containing pouch of claim 15, further comprising an interior plastic bead formed between the first plastic layer and the second plastic layer.

17. The fluid-containing pouch of claim 15, wherein the single layer metal-to-metal melted bond is formed by melting the first foil layer and the second foil layer together.

18. The fluid-containing pouch of claim 15, wherein the first plastic layer and the second plastic layer are substantially removed from the substantially liquid and gas impermeable perimeter seal region by the laser welding.

19. The fluid-containing pouch of claim 15, wherein the liquid and gas impermeable perimeter seal region further 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.

20. The fluid-containing pouch of claim 15, wherein the substantially liquid and gas impermeable perimeter seal region further comprises an undulating pattern formed by crimping the seal region.

21. The fluid-containing pouch of claim 20, wherein in the undulating pattern comprises a plurality of bends.

22. 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, wherein the sealed region comprises a sealed perimeter region, and 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

(i) forming an interior plastic seal bead by melting the first and second plastic layer together to substantially prevents a calibrant liquid from contacting either of or both of the first and second foil layers and

(ii) forming a single layer metal-to-metal melted bond by melting the first foil layer and the second foil layer.

23. The method of claim 22, wherein the pouch yields a Pouch Integrity Test Δ

pCO ₂ value of less than 10 mm Hg.

24. The method of claim 22, wherein the single layer metal-to metal melted bond is formed by ultra-sonic welding, laser welding, or metal-to-metal welding.

25. The method of claim 22, wherein the first plastic layer and the second plastic layer comprise lacquer layer.

26. The method of claim 22, further comprises forming a cavity in the first sheet, and depositing the fluid in the cavity.