Calibration fluid for calibrating a sensor for measuring a blood value and methods for producing and using the fluid

• US 6,599,746 B1
• Filed: 12/04/2000
• Issued: 07/29/2003
• Est. Priority Date: 06/04/1998
• Status: Expired due to Term

• Current Assignee: Sphere Medical Limited (Sphere Medical Holding Ltd.)
• Original Assignee: Siemens AG
• Inventors: Gumbrecht, Walter
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US09/701,882
• Time in Patent Office: 967 Days
• Field of Search: 436/8, 436/19, 436/149, 436/150, 252/408.1, 422/98, 73/10.6, 73/191
• US Class Current: 436/19
• CPC Class Codes: G01N 2496/70 Blood gas control solutios containing dissolved oxygen, bicarbonate and the like
• 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 436/109163 Inorganic standards or controls

Abstract

The calibration fluid is composed of a biocompatible electrolyte that, at 37° C., exhibits a concentration of bicarbonate ions that lies in the normal physiological range of the concentration of the bicarbonate ions of the blood, exhibits a pH value that lies within a pH value range within 2 through 13 containing the value 7.41 and has a specific ionic strength. In order to enable a calibration of the sensor with a higher precision compared to a known calibration fluid of this type both in vivo as well as in vitro, the ionic strength of the fluid at 37° C. is selected such that it lies in the normal physiological range of the ionic strength of the blood.

Claims

1. Calibration fluid for calibration of a sensor for measuring a blood value, comprising (i) a biocompatible electrolyte that at 37°

C. exhibits a concentration of bicarbonate ions of about 24 mmol/l±

5 mmol/l, a pH value that is in the range of 5 through 9 including a value 7.41, and has an ionic strength of about 155 mmol/l±

10 mmol/l, and (ii) other ion types contained in normal, physiological blood, wherein said ion types are contained in the fluid in concentrations substantially equivalent to normal physiological concentrations of said ion types in blood such that a diffusion voltage of less than 1 mV occurs at a boundary surface between the fluid and normal, physiological blood;

said fluid further comprising an organic physiological buffer.

2. Fluid according to one claim 1, which has an osmolarity that lies in the range 295 mosmol/l±

20 mosmol/l.

3. Fluid according to claim 1, which has a pH value in the range between 6.6 and 8.0.

4. Fluid according to claim 1, wherein the organic buffer is defined by a specific Tris/TrisH⁺ ratio.

5. Fluid according to claim 1 wherein the organic buffer is defined by a specific R-PO₄²⁻

/R-HPO₄⁻

ratio wherein R is an organic radical.

6. Fluid according to claim 1, which has a sum of all partial pressures of the fluid that is lower than a pressure that bears on the fluid.

7. Fluid according to claim 6, wherein the partial pressure of N₂ at 37°

C. in the fluid is lower than a value of this pressure in normal, physiological blood at this temperature.

8. Fluid according to claim 7, wherein the N₂ partial pressure of the fluid is essentially equal to zero.

9. A method for measuring a blood value comprising the steps of providing a calibration fluid composed of (i) a biocompatible electrolyte that at 37°

C. exhibits a concentration of bicarbonate of about 24 mmol/l±

5 mmol/l, a pH value in a range of 5 through 9, and an ionic strength that is about 155 mmol/l±

10 mmol/l, and (ii) other ion types contained in normal, physiological blood, wherein said ion types are contained in the fluid in concentrations substantially equivalent to normal physiological concentrations of said ion types in blood such that a diffusion voltage of less than 1 mV occurs at a boundary surface between the fluid and normal, physiological blood, said fluid further containing an organic physiological buffer;

providing a potentiometric sensor having a measuring electrode for measuring a blood value and a reference electrode; and

using the fluid as a bridging electrolyte between the measuring electrode and the reference electrode.

10. A method of manufacturing a calibration fluid comprising (i) a biocompatible electrolyte that at 37°

C. exhibits a concentration of bicarbonate ions of about 24 mmol/l±

5 mmol/l, a pH value in a range of 5 through 9, and an ionic strength of about 155 mmol/l±

10 mmol/l, and (ii) other ion types contained in normal, physiological blood, wherein said ion types are contained in the fluid in concentrations substantially equivalent to normal physiological concentrations of said ion types in blood such that a diffusion voltage of less than 1 mV occurs at a boundary surface between the fluid and normal, physiological blood, said fluid further containing an organic physiological buffer, said method comprising dissolving a specific quantity of an essentially salt-free, aqueous solvent NaHCO₃ together with at least one other biocompatible salt of a weight ratio relative to one another such that the calibration fluid subsequently exhibits a bicarbonate ion concentration at 37°

C. in a normal physiological range of blood, a pH value in a range of 5 through 9 including a value 7.41 and an ionic strength in a range similar to normal physiological blood.