Blood sugar analyzer having fixed enzyme membrane sensor

• US 4,420,564 A
• Filed: 11/04/1981
• Issued: 12/13/1983
• Est. Priority Date: 11/21/1980
• Status: Expired due to Fees

• Current Assignee: Thomson-CSF
• Original Assignee: Fuji Electric Company Limited (Fuji Electric Systems Company Limited)
• Inventors: Tsuji, Nobuhiko, Ishida, Keiichi, Endoh, Koichi, Hamada, Toshiyoshi, Nakamura, Keijiroh
• Primary Examiner(s): Marantz, Sidney
• Application Number:
  US06/318,000
• Time in Patent Office: 769 Days
• Field of Search: 422/81, 435/288, 435/291, 435/817, 204/195 B, 204/1 T, 364/415, 364/416, 364/497
• US Class Current: 204/403.11
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: Y10S 435/817 Enzyme or microbe electrode
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A blood sugar analyzing apparatus has a reaction cell which houses a fixed enzyme membrane sensor and a measuring electrode which receives a blood specimen which causes a chemical reaction between the blood specimen and said fixed enzyme membrane for measuring the blood sugar concentration in the specimen on the basis of a reaction current signal generated in the sensor by the chemical reaction. The analyzing apparatus has a microcomputer for calculating a conversion coefficient used for converting the reaction current into a blood sugar concentration value by introducing a standard solution having a known blood sugar concentration, for storing data representing the value of said conversion coefficient, for calculating a blood sugar concentration value of a test specimen based upon the stored conversion coefficient value and reaction current from the test specimen. A display and printer provide a read-out of the blood sugar concentration value obtained. The microcomputer controls temperature and timing of the measurement process, as well as other control functions.

Claims

1. A blood sugar analyzing apparatus having a reaction cell which houses a fixed enzyme membrane sensor and a measuring electrode and which receives a blood specimen, said fixed enzyme membrane sensor measuring the blood sugar concentration in the blood specimen as a function of a reaction current signal generated in the sensor by the chemical reaction, and means for calculating a reaction current offset for adjusting the measured reaction current value to more accurately detect the actual blood sugar concentration by subtracting said offset from said measured reaction current value;

and said apparatus having monitoring means for sensing a plurality of operational values including reaction cell current, reaction cell temperature and reaction current offset, to compare said sensed values with predetermined corresponding ranges, and to display an error signal when at least one of said values exceeds it corresponding range, to thereby provide information concerning operation conditions and maintenance needs to an operator.

2. The apparatus as set forth in claim 1 wherein the monitoring means further comprises means for sensing the temperature near the chemical reaction in the reaction cell and for producing a sensor output signal having a value proportional to the sensed temperature, means for comparing the sensor output signal value to a value corresponding to a target temperature and for producing a differential output signal indicative of the difference between the sensed and target temperature, and means for converting the differential output signal into coded output signals indicating which one of several exclusive ranges said sensed temperature falls within, means for controlling a heater to maintain the specimen in the temperature range which includes the target temperature in response to said coded output signals, and wherein measurement of blood sugar concentration is effected only when the sensed temperature is within the range which includes the target temperature as indicated by a corresponding coded output signal.

3. The apparatus as set forth in claim 1 further including means for removing an offset signal from the reaction current signal comprising:

a differential amplifier which receives the reaction current signal in the form of an analog input signal at a first input and having a second input;

an A/D converter for converting the output from said differential amplifier into a digital output signal;

a control circuit for monitoring said analog input signal and for detecting when said analog input signal falls to a value of about zero and for generating a control signal in response to the analog input signal reaching a predetermined value;

memory means for storing an offset portion of said differential amplifier output signal in the form of a digital output signal generated by said A/D converter when the control circuit detects the analog input signal falling to a value of about zero;

a D/A converter for converting the offset portion stored in said memory means into an analog signal and for supplying said analog signal into the second input of the differential amplifier in response to a control signal from said control circuit;

and wherein the differential amplifier removes a signal from the analog input signal corresponding to the offset portion.

4. The apparatus as set forth in claim 1 further including

an amplifier with means for adjusting the gain thereof for amplifying an analog input signal from said reaction current signal;

an A/D converter for receiving the output signal from said amplifier and for converting said output signal into a digital signal;

a control circuit for determining whether the output from said amplifier is within a predetermined range by comparing said digital signal to predetermined values, and for generating a control signal which increases the gain at said amplifier when said amplifier output is below a predetermined value and which decreases the gain at the amplifier when said amplifier output is above a predetermined value, to thereby maintain the level of the input signal to the A/D converter within a predetermined range.

5. The apparatus as set forth in claim 1 including a control means comprising a digital control device for automatically executing the operation of a pump for feeding specimens and washing solution into and out of the reaction cell under the control of a sequence program, wherein said digital control device periodically receives a timing signal which transfers the operational mode of the analyzing apparatus from the sequence program to a timing program, and wherein said timing program monitors and controls the time of operation of said pump by the sequence program.

6. The apparatus as set forth in claim 1 including control means for producing a control instruction to start a measurement sequence, said control means having a hold-free means for preventing operation of the analyzing apparatus from being advanced to a washing mode of operation after said chemical reaction has been completed, release means for releasing the condition of the analyzing apparatus from the hold-free condition, and decision means for determining which of the hold-free means and release means should be activated in response to the activation of a single manually actuable switch means on the basis of the present operational mode of the analyzing apparatus.

7. The apparatus as set forth in claim 1 further including means for storing data representing first and second conversion coefficient values obtained from two standard solutions having different blood sugar concentration values each in a different range corresponding to first and second ranges of reaction currents, respectively, means for determining which range of reaction current the measured reaction current from a blood test specimen falls within, and for calculating a blood sugar concentration value for the test specimen using the corresponding stored conversion coefficient value.

8. The apparatus as set forth in claim 7 further including means for calculating a third conversion coefficient value corresponding to a reaction current in a third range between the first and second ranges of reaction current values and for calculating a blood sugar concentration value for a test specimen using said third conversion coefficient when the reaction current is in said third range.

9. The apparatus as set forth in claim 1 further including means for lowering the value of the reaction current offset whenever the actual reaction current is less than the reaction current offset value, so that the actual reaction current value used to obtain the blood sugar concentration always exceeds the reaction current offset value.

15. The apparatus as set forth in claims 1, 10, 11, 12 or 13 wherein said display means comprises a printer.

10. A blood sugar analyzing apparatus having a reaction cell which houses a fixed enzyme membrane sensor and a measuring electrode and which receives a blood specimen which causes a chemical reaction between the blood specimen, said fixed enzyme membrane sensor measuring the blood sugar concentration in the blood specimen as a function of a reaction current signal generated in the sensor by the chemical reaction, said apparatus having means for monitoring the temperature in the reaction cell, means for comparing said monitored temperature value with a predetermined, measurement range to ascertain whether the temperature of the reaction cell is outside of said predetermined temperature range, and visual display means for indicating when said temperature is outside of said predetermined temperature range.

11. A blood sugar analyzing apparatus having a reaction cell which houses a fixed enzyme membrane sensor and a measuring electrode and which receives a blood specimen which causes a chemical reaction between the blood specimen, said fixed enzyme membrane sensor measuring the blood sugar concentration in the blood specimen on the basis of a reaction current signal generated in the sensor by the chemical reaction, said apparatus having means for monitoring the reaction current generated in the sensor, means for comparing the monitored value of reaction current with a predetermined reaction current measurement range to ascertain whether the reaction current is outside of said predetermined reaction current range, and visual display means for indicating when said reaction current is outside of said predetermined reaction current range.

12. A blood sugar analyzing apparatus having a reaction cell which houses a fixed enzyme membrane sensor and a measuring electrode and which receives a blood specimen which causes a chemical reaction between the blood specimen, said fixed enzyme membrane sensor measuring the blood sugar concentration in the blood specimen as a function of a reaction current signal generated in the sensor by the chemical reaction, said apparatus having means for monitoring the reaction current offset, means for comparing the reaction current offset with a predetermined reaction current offset measurement range to ascertain whether the reaction current offset is outside said predetermined reaction current offset range, and visual display means for indicating when said reaction current is outside of said predetermined range.

13. A blood sugar analyzing apparatus having a reaction cell which houses a fixed enzyme membrane sensor and a measuring electrode and which receives a blood specimen, said fixed enzyme membrane sensor measuring the blood sugar concentration in the blood specimen on the basis of a reaction current signal generated in the sensor by the chemical reaction, said apparatus having means for storing data representing first and second conversion coefficient values obtained from two standard solutions having different blood sugar concentration values each in a different range corresponding to first and second ranges of reaction currents, respectively, means for determining which range of reaction current the measured reaction current from a blood test specimen falls within, and for calculating a blood sugar concentration value for the test specimen using the corresponding stored conversion coefficient value.

14. The apparatus as set forth in claim 13 further including means for calculating a third conversion coefficient value corresponding to a reaction current in a third range between the first and second ranges of reaction current values and for calculating a blood sugar concentration value for a test specimen using said third conversion coefficient when the reaction current is in said third range.