Method for measuring glucose

• US 5,271,815 A
• Filed: 12/26/1991
• Issued: 12/21/1993
• Est. Priority Date: 12/26/1991
• Status: Expired due to Fees

• Current Assignee: Segars California Partners, LP
• Original Assignee: VIA Medical Corporation (Medtronic Plc)
• Inventors: Wong, David K.
• Primary Examiner(s): TUNG, TA HSUNG
• Application Number:
  US07/814,099
• Time in Patent Office: 726 Days
• Field of Search: 204/153.1, 204/153.12, 204/153.17, 204/402, 204/403, 204/415, 204/400
• US Class Current: 205/778
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

This invention provides an electrochemical sensor capable of measuring the glucose level of body fluids, especially blood. More particularly, this invention also relates to the use of such a glucose sensor in an automated bedside blood chemistry system which facilitates the operation of the sensor.

Claims

1. A method for measuring a glucose content of a body fluid using an electrochemical glucose sensor, said method consisting essentially of:

exposing said sensor, said sensor using oxygen partial pressure as an indirect measurement of glucose concentration, in an oxygen-containing, low-glucose solution until a baseline sensor output is obtained;

exposing said sensor, after said exposure, to an oxygen-containing, glucose-containing sample of body fluid for a time sufficient to reach glucose saturation of said sensor;

removing said sensor from said oxygen-containing, glucose-containing sample of body fluid followed by returning said sensor to said low-glucose solution;

measuring a time required for said sensor output to reach a fixed level compared to said baseline sensor output, said time being called measured time-to-recover;

determining a calibration time-to-recover by exposing said glucose sensor to at least one solution containing oxygen and having a known glucose concentration until glucose saturation of the sensor output is reached, followed by removing said sensor from said solution of known glucose concentration followed by placing of said sensor in said oxygen-containing, low glucose solution and measuring a time required for said sensor output to reach a fixed level compared to said baseline sensor output, said time being called calibration time-to-recover; and

measuring the glucose content of said sample of body fluid by comparing said measured time-to-recover to said calibration time-to-recover.

2. A method of measuring said glucose content of a body fluid as disclosed in claim 1 wherein said body fluid is blood.

3. A method of measuring said glucose content of a body fluid as disclosed in claim 1 wherein said oxygen-containing low-glucose solution contains essentially zero glucose.

4. A method of measuring the glucose content of a body fluid as described in claim 1 wherein said glucose sensor is essentially a polarographic oxygen electrode assembly coated with a surface layer containing an enzyme that catalyzes the reaction of glucose with oxygen.

5. A method of measuring the glucose content of a body fluid as described in claim 4 wherein said enzyme is glucose oxidase.

6. A method of measuring the glucose content of a body fluid as described in claim 4 wherein said surface layer is less than 0.01 inch thick but more than 0.00001 inch thick.

7. The method of measuring the glucose content of a body fluid as described in claim 4 wherein said polarographic oxygen electrode assembly coated with a surface layer of an enzyme that catalyzes the reaction of glucose with oxygen is additionally coated with a membrane that is more permeable to oxygen than to glucose.

8. The method of measuring the glucose content of a body fluid as described in claim 7 wherein said membrane consists essentially of a perfluorinated ionomer.

9. The method of measuring the glucose content of a body fluid as described in claim 4 wherein said polarographic oxygen electrode assembly consists essentially of a platinum working electrode and a silver/silver chloride counter electrode and wherein said surface layer comprises a gel mixture containing an enzyme to catalyze the oxidation of glucose.

10. A method of measuring the glucose content of a body fluid as described in claim 9 wherein said gel mixture of an enzyme that catalyzes the oxidation of glucose consists essentially of glucose oxidase, human serum albumin, polyvinyl alcohol and glutaraldehyde.

11. A method for measuring the glucose level in body fluid, said method consisting essentially of;

exposing a glucose sensor to a low-glucose, oxygen-containing baseline solution by moving said baseline solution between a solution container and said glucose sensor using a fluid flow device;

measuring an output of said glucose sensor while said sensor is exposed to said low-glucose, oxygen-containing baseline solution;

purging said low-glucose, oxygen-containing baseline solution;

exposing said glucose sensor to a sample of body fluid which contains oxygen and glucose by moving said sample of body fluid using a fluid flow device, for a time sufficient to reach glucose saturation of the output of said sensor;

purging said sample of body fluid which contains oxygen and glucose from the said glucose sensor and returning said baseline solution to said sensor;

measuring the time required for said sensor output to reach a fixed level as compared to the original baseline output, said time being called measured time-to-recover;

determining a calibration time-to-recover by exposing said glucose sensor to at least one calibration solution containing oxygen and having a known glucose concentration, by moving said calibration solution using a fluid flow device, for a time sufficient to reach glucose saturation of the output of said sensor, purging of said calibration solution from said glucose sensor and returning said baseline solution to said sensor, and measuring the time required for said sensor output to reach a fixed level as compared to the original baseline output, said time being called calibration time-to-recover; and

measuring the glucose content of said sample of body fluid by comparing said measured time-to-recover of said sensor to said calibration time-to-recover.

12. A method of measuring the glucose content of a body fluid as described in claim 11 wherein said body fluid is blood.

13. A method of measuring the glucose content of a body fluid as described in claim 11 wherein said low-glucose solution contains essentially zero glucose.

14. A method of measuring the glucose content of a body fluid as described in claim 11 wherein said glucose sensor is essentially a polarographic oxygen electrode assembly coated with a surface layer containing an enzyme that catalyzes the reaction of glucose with oxygen.

15. A method of measuring the glucose content of a body fluid as described in claim 14 wherein said enzyme is glucose oxidase.

16. A method of measuring the glucose content of a body fluid as described in claim 14 wherein the polarographic oxygen electrode assembly coated with a surface layer of an enzyme that catalyzes the reaction of glucose with oxygen is additionally coated with a membrane that is more permeable to glucose than to oxygen.

17. A method of measuring the glucose content of a body fluid as described in claim 16 wherein said membrane consists essentially of a perfluorinated ionomer.

18. A method of measuring the glucose content of a body fluid as described in claim 17 wherein said layer of membrane material is less than 0.010 inch thick but more than 0.00001 inch thick.

19. A method of measuring the glucose content of a body fluid as described in claim 11 wherein said glucose sensor is coated with a surface layer which is a gel mixture of an enzyme that catalyzes the oxidation of glucose.

20. A method of measuring the glucose content of a body fluid as described in claim 19 wherein said gel mixture of an enzyme that catalyzes the oxidation of glucose consists essentially of glucose oxidase, human serum albumin, polyvinyl alcohol and glutaraldehyde.

21. An improved method for measuring glucose content of a body fluid using an electrochemical glucose sensor, wherein said improvement consists essentially of:

exposing said sensor, said sensor using oxygen partial pressure as an indirect measurement of glucose concentration, in an oxygen-containing, low-glucose solution until a baseline sensor output is obtained;

exposing said sensor to an oxygen-containing, glucose-containing sample of body fluid for a time sufficient to reach glucose saturation of said sensor;

removing said sensor from said oxygen-containing, glucose containing sample of body fluid followed by returning said sensor to said low-glucose solution;

measuring a time required for said sensor output to recover to a fixed level compared to said baseline sensor output, said time being called measured time-to-recover;

determining a calibration time-to-recover by exposing said glucose sensor to at least one solution containing oxygen and having a known glucose concentration until glucose saturation of the sensor output is reached, followed by removing said sensor from said solution of known glucose concentration followed by placement of said sensor in said oxygen-containing, low glucose solution and measuring a time required for said sensor output to recover to a fixed level compared to said baseline output, said time being called calibration time-to-recover; and

measuring the glucose content of said sample of body fluid by comparing said measured time-to-recover with said calibration time-to-recover.