Pressurized packaged reference liquid for blood gas analysis

• US 4,960,708 A
• Filed: 10/13/1988
• Issued: 10/02/1990
• Est. Priority Date: 10/13/1988
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Baxter International Inc.
• Inventors: Zowtiak, John M., Mayall, Bruce I.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Wallen, T. J.
• Application Number:
  US07/257,017
• Time in Patent Office: 719 Days
• Field of Search: 436/8-19, 252/408.1, 73/1 R, 73/1 G
• US Class Current: 436/11
• CPC Class Codes: G01N 2496/70 Blood gas control solutios containing dissolved oxygen, bicarbonate and the like
• CPC Class Codes: G01N 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/0006 Calibrating gas analysers
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/102499 Blood gas standard or control

Abstract

A packaged single-phase reference liquid comprising a gas and liquid-impermeable sealed container and a reference liquid containing a highly diffusible gas.

Claims

1. A packaged single-phase reference liquid, which comprises:

(a) a sealed, flexible, gas- and liquid-impermeable container, and

(b) an aqueous solution contained in said container without any gas phase, said solution containing a known concentration of oxygen or carbon dioxide or both, wherein the sum of the partial pressures of oxygen and carbon dioxide are less than about 350 mm Hg (at 37°

C.), said solution further containing a highly diffusible gas at a concentration such that the total gas pressure is from about 550 to about 800 mm Hg (at 37°

C.), and wherein the total hydraulic pressure within the container is greater than the total gas pressure and is sufficient to prevent a gas phase separation during conditions of storage and use.

2. The packaged reference liquid of claim 1, wherein the aqueous solution contains dissolved oxygen and carbon dioxide, the partial pressure of oxygen being from about 0 mm Hg to about 300 mm Hg (37°

C.) and the partial pressure of carbon dioxide being from about 20 to about 100 mm Hg (at 37°

C.).

3. The packaged reference liquid of claim 1, wherein the total of all gas partial pressures is from about 700 to about 800 mm Hg (at 37°

C.).

4. The packaged reference liquid of claim 1 or 2, wherein the highly diffusible gas is hydrogen or helium.

5. The packaged reference liquid of claim 4, wherein the highly diffusible gas is helium.

6. The reference liquid of claim 1, wherein the aqueous solution is buffered to a known pH.

7. The reference liquid of claim 6, wherein said pH is from about 6.5 to about 7.5.

8. The packaged reference liquid of claim 1, wherein said aqueous solution is pH-buffered isotonic normal saline having substantially the same osmolality as human blood serum.

9. The packaged reference liquid of claim 1, wherein the container is a bag.

10. The packaged reference liquid of claim 9, wherein said bag is constructed from a laminate having at least one layer impermeable to gas-liquid transmission.

11. The packaged reference liquid of claim 10, wherein said impermeable layer is a metal layer.

12. The packaged reference liquid of claim 1, wherein the container is a metal tube.

13. The packaged reference liquid of claim 1, wherein the container is a syringe having a movable plunger biased against the reference liquid.