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WO1998001752A1 - Dispositif pour reduire au minimum le degazage dans un liquide - Google Patents

Dispositif pour reduire au minimum le degazage dans un liquide Download PDF

Info

Publication number
WO1998001752A1
WO1998001752A1 PCT/US1997/011863 US9711863W WO9801752A1 WO 1998001752 A1 WO1998001752 A1 WO 1998001752A1 US 9711863 W US9711863 W US 9711863W WO 9801752 A1 WO9801752 A1 WO 9801752A1
Authority
WO
WIPO (PCT)
Prior art keywords
pouch
fluid
gas
pressure
outgassing
Prior art date
Application number
PCT/US1997/011863
Other languages
English (en)
Inventor
Victor E. Kimball
Irvin T. Pierskalla
Edward J. Anderson
Original Assignee
Optical Sensors Incorporated
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Optical Sensors Incorporated filed Critical Optical Sensors Incorporated
Priority to AU35972/97A priority Critical patent/AU3597297A/en
Publication of WO1998001752A1 publication Critical patent/WO1998001752A1/fr

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/38—Articles or materials enclosed in two or more wrappers disposed one inside the other
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/18—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient
    • B65D81/20—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas
    • B65D81/2046—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas under superatmospheric pressure
    • B65D81/2061—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient under vacuum or superatmospheric pressure, or in a special atmosphere, e.g. of inert gas under superatmospheric pressure in a flexible container

Definitions

  • This invention relates generally to fluid packaging. More particularly, the invention relates to devices for packaging fluids containing dissolved gases and to methods of using such devices to minimize outgassing of such fluids.
  • Flexible packages are commonly used to contain fluids for convenient and inexpensive storing, transporting and dispensing.
  • flexible packages containing foods, juices, soft drinks and dairy products are available in the retail marketplace.
  • Sterile solutions such as normal saline, dextrose, and the like can also be contained in flexible packages.
  • reference fluids that can be used to calibrate and perform quality control measurements on blood gas analysis and other types of medical equipment are often provided in a flexible package.
  • a flexible package is fabricated from a polymeric material. Such a material is easily manufactured and fabricated in the form of a package which is readily sterilized.
  • the package may be made of a metal-plastic laminate.
  • a laminated package made from layers of a low gas-permeability polymer and a metal foil provides the additional benefit of being substantially gas-impermeable.
  • the use of a pouch-like container in a method of preparing sterilized, packaged articles is described in U.S. Patent No. 3,892,058 to Komatsu et al.
  • the container described in Komatsu et al. is a laminate of flexible sheet materials.
  • the inner layer is composed of a heat-sealable resin, such as a polyamide.
  • the outer layer is composed of a heat-resistant resin, such as a polyester film.
  • Sandwiched between the inner and outer layers is a metal foil, such as aluminum.
  • U.S. Patent No. 4,116,336 to Sorensen et al. describes the use of a flexible, gas-tight package to contain a fluid containing dissolved O 2 and/or CO 2 .
  • the fluid may be used for calibrating or quality control monitoring of blood gas measuring equipment.
  • the flexible container is a plastic-laminated metal foil, e.g., aluminum.
  • the exterior surface of the metal foil is laminated with a plastic foil, such as a polyester film, to prevent scratching, and the like.
  • the inner surface of the metal foil is laminated with a plastic having low gas permeability and good weldability, such as poly vinylidene chloride or polyethylene terephthalate.
  • Reference fluids useful for calibrating and performing quality control measurements on blood gas analysis or other medical equipment provide a standard against which the equipment is calibrated with respect to, for example, hydrogen ion concentration (pH) and dissolved oxygen and carbon dioxide partial pressure (pO 2 and pCO 2 , respectively).
  • pH hydrogen ion concentration
  • pO 2 and pCO 2 dissolved oxygen and carbon dioxide partial pressure
  • many of the reference fluids are used in in vivo or in situ applications, such as with an indwelling arterial catheter, as described in U.S. Patent No.
  • the solubility of a gas in a fluid is dependent on not only the nature of the fluid and of the gas but also on the temperature and pressure of the fluid. It is well known in the art that the effects of temperature and pressure on gas solubility are interrelated. At any given temperature, the solubility of a gas in a fluid increases with increasing pressure. Similarly, at any given pressure, the solubility of most gases in a fluid decreases with increasing temperature.
  • Gases may be dissolved in the fluid by bubbling with known concentrations of, for example, O 2 and CO 2 , to provide a liquid with known pO 2 and pCO 2 .
  • Fluids thus prepared are placed and sealed in a flexible package for shipping and storage. Exposing the filled and sealed pouch to an elevated temperature, reduced pressure, or both, may result in outgassing. For example, if the filled and sealed pouch is exposed to low pressure during shipment and/or storage, outgassing may occur.
  • fluids containing dissolved gases may be prepared at pressures lower than and/or temperatures greater than ambient pressure to reduce the potential for outgassing.
  • subsequent exposure of the package to conditions in which the pressure is less than that used during manufacture or to temperatures that are higher than those used during manufacture may result in outgassing.
  • Outgassing results in a diminution of the partial pressure of the gas in the fluid, thereby compromising the utility of the fluid as a reference fluid.
  • Such effects are most often seen during shipment of the packages under uncontrolled conditions, shipment to sites at high altitudes (i.e., low pressure), or shipment or storage at elevated temperature.
  • the present invention provides such a device, and involves pressurizing the fluid- filled pouch to minimize outgassing.
  • a method is provided for minimizing outgassing of a gas dissolved in a fluid.
  • a device for minimizing outgassing of a gas dissolved in a fluid.
  • the device includes a sealed, gas-impermeable pouch comprised of a laminate of a metal and a plastic, containing the fluid and the gas dissolved therein. Outgassing during shipping, storage, and/or handling is minimized by providing a compressing means affixed to the pouch.
  • the compressing means is clamping means or an elastomeric band secured to the pouch.
  • the compressing means is a second pouch that encases the first pouch so as to provide a space between the two pouches that can be pressurized with an atmosphere at greater-than- ambient pressure.
  • the second pouch is itself secured by a pressurizing means to maintain the atmosphere between the pouches at a greater-than- ambient pressure.
  • a method for minimizing outgassing of a gas dissolved in a fluid at a predetermined partial pressure.
  • the method comprises providing a sealable, gas-impermeable first pouch containing the fluid and the gas dissolved therein, sealing the first pouch so as to form a gas-tight, sealed pouch that is void of any gas phase, and affixing a compressing means for maintaining the first pouch at a pressure greater than ambient.
  • While these devices and methods can be used for a variety of purposes, depending on the components of the fluid contained in the first pouch, they will primarily be used in shipping and storing reference fluids having a predetermined pH, pO 2 , and/or pCO 2 suitable for use in calibrating or performing quality control measurements on blood gas analysis equipment.
  • FIG. 1 is a cross-sectional view of a first fluid-filled pouch encased within a second pouch according to the present invention.
  • FIGS. 2 A, 2B, 2C, and 2D represent cross-sectional views of a fluid-filled pouch and embodiments of compressing and pressurizing means according to the present invention.
  • partial pressure is used in its conventional sense to refer to the pressure exerted by one component of a mixture of gases, or by a gas dissolved in a fluid, if the component or the gas were present alone in a container.
  • the partial pressure of a gas is generally abbreviated as, for example, “pO 2 " for oxygen, “pCO 2 " for carbon dioxide, and so forth.
  • ambient is used herein to mean standard atmospheric conditions.
  • the term “ambient pressure” is intended to mean approximately 740 mm Hg to about 780 mm Hg.
  • the term “ambient partial pressure” of a gas is intended to mean the partial pressure of a component of the atmosphere in ambient conditions.
  • the ambient partial pressure of O 2 is approximately 150 mm Hg to 155 mm Hg.
  • a pressure that is "greater than ambient” is one that varies from ambient pressure by at least 5%, i.e., 798 mm Hg, preferably by at least 50%, i.e., 1140 mm Hg, more preferably by at least 100%, i.e., 1520 mm Hg.
  • outgassing is used herein to mean the release of a dissolved gas by heating, depressurization, agitation, or the like.
  • the term “outgassing” broadly includes bubble formation or gases otherwise coming out of solution when the temperature of the fluid is increased, when the pressure of the fluid is reduced, such as at high altitudes, when the fluid is agitated during shipping, or when any combination of increased temperature, decreased pressure and agitation occurs.
  • compressing means and “pressurizing means” are used herein to refer to a means for producing a force on a flexible package so that the contents thereof are maintained at a greater-than-ambient pressure, preferably at a pressure effective to prevent outgassing. Suitable materials for "compressing means” and “pressurizing means” will be outlined below.
  • charge or “charging” as used herein is intended to mean the introduction of an atmosphere or a gas into a space designed to contain the atmosphere or gas.
  • Charging a space with an atmosphere or a gas includes but is not limited to introducing an atmosphere or a gas into such a space at ambient or nonambient pressure.
  • Optional or “optionally” means that the subsequently described circumstance may or may not occur, and that the description includes instances in which said circumstance occurs and instances in which it does not.
  • the phrase “optionally including an additional plastic layer” means that an additional plastic layer may or may not be present, and the description includes both the instance when the additional plastic layer is present and the instance when the additional plastic layer is not present.
  • the device comprises an inner pouch 12 and an outer pouch 14 which encases the inner pouch and provides a space 16 between the inner pouch 12 and the outer pouch 14.
  • Inner pouch 12 is gas-tight and contains a fluid 18 in which a gas has been dissolved.
  • Inner pouch 12 can be of any size and the volume of the fluid 18 contained in the pouch any volume, but typically the size of the pouch is sufficient to contain about 0.5 to about 500 mLs or more.
  • Inner pouch 12 is filled with fluid 18 so that there is no gas phase enclosed within the pouch.
  • Inner pouch 12 may be fabricated from any flexible gas-tight material or from a laminate of materials. Such a laminate is described in U.S. Patent No. 4,116,336 to Sorensen et al.
  • inner pouch 12 is composed of layers 20, 22, and 24 that are laminated together and sealed by, for example, welding the interior layer 20 to form welding seam 26 at edge 28.
  • the opposite edge of the bag 30 is also welded along a welding seam 32.
  • the interior layer 20 of the laminate is preferably a low-permeability plastic, examples of which are well known in the art, and has a thickness of about 25 ⁇ m to about 75 ⁇ m.
  • Layer 22 is preferably a metal foil, such as aluminum.
  • an additional plastic layer may be present between layers 20 and 22 to provide a binder layer.
  • Optional exterior layer 24 is provided as a protective layer over layer 22.
  • the reference fluid may be a medium which contains known analyte concentrations.
  • gases for example, O 2 , CO 2 or the like, hydrogen ion, i.e., pH, or other biological analytes the presence of which may be desirable to assess in a physiologic fluid, e.g., glucose, potassium, calcium, and the like.
  • the reference fluid may contain biocompatible buffers including, for example, bicarbonate, phosphate and fluorocarbon- based synthetic buffers.
  • Outer pouch 14 is preferably constructed of a laminate of layers 20', 22', and 24' using materials similar to those used in layers 20, 22, and 24 in inner bag 12, and sealed by welding interior layer 20' to form welding seam 26' at edge 28' and a welding seam 32' at opposite edge 30'.
  • any flexible, gas-tight package can be used for the outer pouch.
  • Outer pouch 14 is larger than inner pouch 12 so as to encase the inner pouch and to provide a space 16 therebetween.
  • space 16 Prior to sealing the outer pouch, space 16 can be charged with an atmosphere having a predetermined composition and/or an atmosphere at a pressure greater than ambient.
  • the partial pressure of the gas in the atmosphere may be substantially the same as, or slightly biased with respect to the partial pressure of the dissolved gas.
  • inner pouch 12 is pressurized by charging space 16 with an atmosphere at a pressure effective to prevent outgassing.
  • the atmosphere is one containing the gas dissolved in the fluid in the inner pouch and in which the partial pressure of the gas is substantially the same as the partial pressure of the dissolved gas.
  • a device for minimizing outgassing of a gas dissolved in a fluid at a predetermined partial pressure may be best understood by reference to the FIGS. 2A, 2B, 2C, and 2D.
  • FIG. 2A illustrates one preferred embodiment of such a device generally at 40.
  • Flexible pouch 12 containing fluid 18 in which a gas is dissolved may be pressurized.
  • Compressing means 42 is affixed to flexible pouch 12, and is designed to provide a pressure on the pouch effective to minimize outgassing.
  • compressing means 42 is a clamping means.
  • the clamping means preferably comprises the material in which the pouch is packed.
  • flexible pouch 12 may be placed in a paperboard or plastic shipping/storing sleeve 42 that provides a pressure on the gas sufficient to minimize outgassing.
  • the clamping means may also be a spring clip, manufactured by conventional means from any of a variety of metals or plastics, that is biased toward closing.
  • device 50 includes as a compressing means an elastomeric band 52 secured about the flexible pouch 12.
  • FIGS. 2C and 2D illustrate additional embodiments of the invention at 60 and 70, respectively, in which first pouch 12 is encased in second pouch 14, and space 16 formed therebetween is charged with an atmosphere.
  • device 60 includes pressurizing means 42'.
  • pressurizing means 42' is a clamping means as described with respect to FIG. 2A.
  • a preferred clamping means for shipping or storing flexible pouch 12 encased in second pouch 14 comprises the materials in which the second pouch is packaged.
  • device 70 includes pressurizing means 52'.
  • pressurizing means 52' is an elastomeric band as described with respect to FIG. 2B.
  • the disclosed device and method for minimizing outgassing of a gas dissolved in a fluid at a predetermined partial pressure are designed to be used with reference fluids for calibrating and performing quality control measurements of blood gas (O 2 and CO 2 ) and pH sensors situated in an arterial line in a human or animal subject, as described in Kimball et al., supra.
  • reference fluids for calibrating and performing quality control measurements of blood gas (O 2 and CO 2 ) and pH sensors situated in an arterial line in a human or animal subject, as described in Kimball et al., supra.
  • utility can be extended to any type of reference fluid or other fluid in which gases may be dissolved at a predetermined partial pressures that must be maintained within critical tolerance ranges.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un dispositif (10) permettant de réduire au minimum le dégazage d'un gaz dissous dans un liquide à une pression partielle prédéterminée. Le dispositif comprend une première poche (12) contenant le liquide (18) et un élément de compression (14, 42, 42', 52, 52') pour soumettre la première poche à une pressure supérieure à la pression ambiante. L'invention concerne aussi des procédés permettant d'utiliser le dispositif pour réduire au minimum le dégazage.
PCT/US1997/011863 1996-07-08 1997-07-07 Dispositif pour reduire au minimum le degazage dans un liquide WO1998001752A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU35972/97A AU3597297A (en) 1996-07-08 1997-07-07 Device for minimizing outgassing from fluid

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US67695396A 1996-07-08 1996-07-08
US08/676,953 1996-07-08

Publications (1)

Publication Number Publication Date
WO1998001752A1 true WO1998001752A1 (fr) 1998-01-15

Family

ID=24716707

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1997/011863 WO1998001752A1 (fr) 1996-07-08 1997-07-07 Dispositif pour reduire au minimum le degazage dans un liquide

Country Status (2)

Country Link
AU (1) AU3597297A (fr)
WO (1) WO1998001752A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0929470A1 (fr) * 1996-07-08 1999-07-21 Optical Sensors Incorporated Contenant pour maintien d'un gaz dissous
EP2163891A1 (fr) * 2008-09-15 2010-03-17 C & C Ingescience Dispositif et procédé d'étalonnage d'un capteur à ionisation
WO2020020752A1 (fr) * 2018-07-27 2020-01-30 Flexikeg Sas Contenant pour liquide
WO2020020753A1 (fr) * 2018-07-27 2020-01-30 Flexikeg Sas Contenant pour liquide

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4470520A (en) * 1979-01-12 1984-09-11 Corning Glass Works Storage and dispensing of blood gas quality control reagent from a pressurized container
US4960708A (en) * 1988-10-13 1990-10-02 Baxter International Inc. Pressurized packaged reference liquid for blood gas analysis

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4470520A (en) * 1979-01-12 1984-09-11 Corning Glass Works Storage and dispensing of blood gas quality control reagent from a pressurized container
US4960708A (en) * 1988-10-13 1990-10-02 Baxter International Inc. Pressurized packaged reference liquid for blood gas analysis

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0929470A1 (fr) * 1996-07-08 1999-07-21 Optical Sensors Incorporated Contenant pour maintien d'un gaz dissous
EP0929470A4 (fr) * 1996-07-08 2001-05-02 Optical Sensors Inc Contenant pour maintien d'un gaz dissous
EP2163891A1 (fr) * 2008-09-15 2010-03-17 C & C Ingescience Dispositif et procédé d'étalonnage d'un capteur à ionisation
FR2936059A1 (fr) * 2008-09-15 2010-03-19 C & C Ingescience Dispositif et procede d'etalonnage d'un capteur a ionisation
WO2020020752A1 (fr) * 2018-07-27 2020-01-30 Flexikeg Sas Contenant pour liquide
WO2020020753A1 (fr) * 2018-07-27 2020-01-30 Flexikeg Sas Contenant pour liquide
FR3084343A1 (fr) * 2018-07-27 2020-01-31 Flexikeg Contenant pour liquide
FR3084344A1 (fr) * 2018-07-27 2020-01-31 Flexikeg Contenant pour liquide
US11851261B2 (en) 2018-07-27 2023-12-26 Flexikeg Sas Liquid container
US12264004B2 (en) 2018-07-27 2025-04-01 Flexikeg Sas Liquid container

Also Published As

Publication number Publication date
AU3597297A (en) 1998-02-02

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