Method for hydrating and calibrating a sterilizable fiber-optic catheter

• US 5,328,848 A
• Filed: 08/08/1991
• Issued: 07/12/1994
• Est. Priority Date: 07/25/1988
• Status: Expired due to Fees

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Fieggen, Bruce Q., Ali Elmesai, Mohamed R., Fong, Conrad T. O.
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): Wallenhorst, Maureen M.
• Application Number:
  US07/742,627
• Time in Patent Office: 1,069 Days
• Field of Search: 436/8-19, 436/68, 252/408.1
• US Class Current: 436/11
• CPC Class Codes: A61B 2560/0233 Optical standards
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• CPC Class Codes: A61B 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH
• 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
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent

Abstract

The present invention provides an aqueous buffer solution and method and solution for hydrating and calibrating a sensor membrane of a fiber-optic catheter useful for measuring an analyte other than chloride in a physiological milieu. The temperature, gaseous atmosphere, and aqueous buffer solution of the sensor component are controlled throughout the calibration process in order to ensure that the device is calibrated in accordance with its intended use. The solution is chemically compatible with the intended use of the device and provides compensation for evaporative loss, contaminants, or changes in the solution occurring during storage especially in plastic containers.

Claims

1. A method of equilibrating a sensor component membrane of a fiber-optic catheter useful for measuring at least one analyte other than chloride in blood to determine pH, pO₂, or pCO₂ in a blood sample, comprising the step of contacting the sensor component membrane with an aqueous buffer solution containing chloride at a level substantially equal to the level found in blood, for a period of time sufficient to equilibrate the sensor membrane so that an ionic gradient is prevented from forming across the sensor component membrane when the sensor component membrane is contacted with the blood sample.

2. The method of claim 1, wherein the aqueous buffer solution comprises bicarbonate and phosphate ions.

3. The method of claim 1, wherein the aqueous buffer solution consists essentially of:

0.916 g/l potassium phosphate,

3.007 g/l sodium phosphate,

6.136 g/l sodium chloride, and

1.848 g/l sodium bicarbonate, in aqueous solution.

4. A method of equilibrating and calibrating a sensor component membrane and monitoring instrumentation of a fiber-optic catheter useful for measuring at least one analyte other than chloride in a blood sample comprising the steps of:

contacting the sensor component membrane with a first aliquot of an aqueous buffer solution containing chloride at a level substantially equal to the level found in said blood, for a period of time sufficient to equilibrate said sensor component membrane so that an ionic gradient is prevented from forming across the sensor component membrane when the sensor component membrane is contacted with a blood sample;

exposing a second aliquot of the aqueous buffer solution to a controlled gaseous atmosphere to achieve a controlled calibration point value;

contacting the sensor component membrane with the second aliquot of the aqueous buffer solution at the controlled calibration point value; and

,

contacting the sensor component membrane with the blood sample and determining that an ionic gradient does not form across the sensor component membrane.

5. The method of claim 4, wherein the controlled calibration point value is selected from a pH value within the range of pH 7.2 to pH 7.6.

6. The method of claim 5, wherein the controlled calibration point value is a pH value of 7.2.

7. The method of claim 5, wherein the controlled calibration point value is a pH value of 7.6.

8. The method of claim 4, wherein the controlled gaseous atmosphere comprises CO₂, O₂ and N₂.

9. The method of claim 8, wherein the controlled gaseous atmosphere comprises 8.3% CO₂, 8.3% O₂ and 83.4% N₂.

10. The method of claim 8, wherein the controlled gaseous atmosphere comprises 2.8% CO₂, 21% O₂ and 76.2% N₂.

11. The method of claim 4, wherein the aqueous buffer solution consists essentially of:

0.916 g/l potassium phosphate,

3.007 g/l sodium phosphate,

6.136 g/l sodium chloride, and

1.848 g/l sodium bicarbonate, in aqueous solution.

12. A method of equilibrating and calibrating a sensor component membrane and monitoring instrumentation of a fiber optic catheter useful for measuring at least one analyte other than chloride in blood, comprising the steps of:

contacting the sensor component membrane with an aqueous buffer solution containing chloride at a level substantially equal to the level found in said blood, for a period of time sufficient to equilibrate said sensor component membrane so that an ionic gradient is prevented from forming across the sensor component membrane when the sensor component membrane is contacted with a blood sample; and

exposing the aqueous buffer solution and sensor component membrane to a controlled gaseous atmosphere under conditions sufficient to achieve a controlled calibration point value.