Blood component measuring device, method for measuring blood component, and bio-sensor

• US 9,816,957 B2
• Filed: 11/19/2013
• Issued: 11/14/2017
• Est. Priority Date: 12/12/2012
• Status: Active Grant

• Current Assignee: PHC Holdings Corporation
• Original Assignee: Panasonic Healthcare Holdings Co., Ltd.
• Inventors: Fujiwara, Masaki, Yamamoto, Tomohiro
• Primary Examiner(s): Noguerola, Alexander
• Application Number:
  US14/651,125
• Publication Number:
  US 20150323489A1
• Time in Patent Office: 1,456 Days
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

Abstract

Provided is a blood component measuring device or the like that can further suppress the measurement error of a blood component. The device detects an oxidation-reduction current generated by oxidation-reduction when a first voltage is applied to a first electrode pair 21, 22 of a biosensor 1, and converts the oxidation-reduction current (glucose response value) into a glucose conversion value. The device detects a current generated when a second voltage is applied to a second electrode pair 23, 24 of the biosensor 1, and converts the detected current (blood cell amount response value) into a blood cell amount conversion value. The glucose response value is measured more than once and the blood cell amount response value is also measured more than once within a predetermined period after the introduction of the blood into the biosensor 1. A CPU 72 corrects the glucose conversion value measured within the predetermined period based on at least a part of a plurality of glucose conversion values and a plurality of blood cell amount conversion values obtained from the results of measurement.

Claims

1. A blood component measuring device that measures a blood component amount with a biosensor in which blood is introduced, and a blood component contained in the blood is oxidized and reduced by an oxidoreductase,

the device comprising:

a blood component amount measurement means that detects an oxidation-reduction current generated by the oxidation-reduction when a first voltage is applied to a first electrode pair of the biosensor, and that converts the oxidation-reduction current into the blood component amount;

a blood cell amount measurement means that detects a current generated when a second voltage is applied to a second electrode pair of the biosensor, and that converts the detected current into a blood cell amount contained in the blood;

a measurement control means that controls the blood component amount measurement means to apply the first voltage to the first electrode pair, to detect an oxidation-reduction current corresponding to the blood component amount more than once at predetermined timing of measurement of the blood component amount, and thus to measure the blood component amount more than once within a predetermined period after the introduction of the blood into the biosensor, and that also controls the blood cell amount measurement means to apply the second voltage in pulses to the second electrode pair within a predetermined short time before, during, or after the predetermined timing of the measurement of the blood component amount and only at timing of measurement of the blood cell amount in the predetermined period, to detect a current corresponding to the blood cell amount, and thus to measure the blood cell amount more than once within the predetermined period; and

a blood component amount correction means that corrects the blood component amount measured by the blood component amount measurement means based on at least a part of a plurality of blood component amounts measured by the blood component amount measurement means and a plurality of blood cell amounts measured by the blood cell amount measurement means under the control of the measurement control means.

2. The blood component measuring device according to claim 1, comprising:

a storage means that stores record data including a plurality of blood component amounts and a plurality of blood cell amounts that are converted from the respective currents detected more than once within the predetermined period for each blood with a known blood component amount and a known blood cell amount,

wherein the blood component amount correction means compares (i) the record data including a blood component amount that is closely approximated to any blood component amount of the plurality of blood component amounts measured and the plurality of blood cell amounts measured with (ii) measured data including the plurality of blood component amounts measured by the blood component amount measurement means and the plurality of blood cell amounts measured by the blood cell amount measurement means, and then the blood component amount correction means corrects the measured blood component amount to the blood component amount of blood having the record data that is most closely approximated to the measured data.

3. The blood component measuring device according to claim 2, wherein the blood component amount correction means compares (i) any combination of a blood component amount and a blood cell amount in the plurality of blood component amounts and the plurality of blood cell amounts measured under the control of the measurement control means with (ii) the record data including the same combination of a blood component amount and a blood cell amount in the plurality of blood component amounts and the plurality of blood cell amounts stored in the storage means, and then the blood component amount correction means corrects the measured blood component amount to the blood component amount of blood having the most approximate record data.

4. The blood component measuring device according to claim 2, wherein the measurement control means controls the blood component amount measurement means to measure the blood component amount in a first period included in a first half of the predetermined period and in a second period included in a second half of the predetermined period.

5. The blood component measuring device according to claim 4, wherein the measurement control means controls the blood component amount measurement means to measure the blood component amount at least in a first period of the predetermined period during which a change in temperature of the blood introduced into the biosensor is large and in a second period of the predetermined period during which a change in temperature of the blood introduced into the biosensor is stable.

6. The blood component measuring device according to claim 4, wherein the measurement control means controls the blood cell amount measurement means to measure the blood cell amount at least in the first period and in the second period, during each of which the blood component amount is measured by the blood component amount measurement means.

7. The blood component measuring device according to claim 4, wherein the record data and the measured data include a group of the blood component amount measured in the first period and the blood cell amount measured in the first period, a group of the blood component amount measured in the first period and the blood cell amount measured in the second period, a group of the blood component amount measured in the second period and the blood cell amount measured in the first period, and a group of the blood component amount measured in the second period and the blood cell amount measured in the second period, and

wherein the blood component amount correction means compares the same group between the record data and the measured data.

8. The blood component measuring device according to claim 1, comprising:

a storage means that stores record data including a plurality of blood component amounts and a plurality of blood cell amounts that are converted from the respective currents detected more than once within the predetermined period for each blood with a known blood component amount and a known blood cell amount and for each ambient temperature; and

a temperature detection means that detects an ambient temperature,

wherein the blood component amount correction means extracts record data with a temperature closer to the ambient temperature detected by the temperature detection means, and compares the extracted record data with measured data including the plurality of blood component amounts measured by the blood component amount measurement means and the plurality of blood cell amounts measured by the blood cell amount measurement means, and then the blood component amount correction means corrects the measured blood component amount to the blood component amount of blood having the record data that is most closely approximated to the measured data.

9. The blood component measuring device according to claim 1, wherein the blood component amount correction means performs a multivariate analysis with the use of at least a part of the plurality of blood component amounts and the plurality of blood cell amounts to correct the blood component amount measured by the blood component amount measurement means.

10. The blood component measuring device according to claim 1, wherein the measurement control means allows the second voltage to be applied to the second electrode pair only at the timing of the measurement of the blood cell amount in the predetermined period while the first voltage is being applied to the first electrode pair.

11. A method for measuring a blood component that measures a blood component amount with a biosensor in which blood is introduced, and a blood component contained in the blood is oxidized and reduced by an oxidoreductase,

the method comprising the following steps of:

(i) detecting an oxidation-reduction current generated by the oxidation-reduction when a first voltage is applied to a first electrode pair of the biosensor, and converting the oxidation-reduction current into the blood component amount; and

(ii) detecting a current generated when a second voltage is applied to a second electrode pair of the biosensor, and converting the detected current into a blood cell amount contained in the blood,

wherein the blood component amount is measured more than once within a predetermined period after the introduction of the blood into the biosensor by applying the first voltage to the first electrode pair, and detecting an oxidation-reduction current corresponding to the blood component amount more than once at predetermined timing of measurement of the blood component amount, and the blood cell amount is also measured more than once within the predetermined period by applying the second voltage in pulses to the second electrode pair within a predetermined short time before, during, or after the predetermined timing of the measurement of the blood component amount and only at timing of measurement of the blood cell amount in the predetermined period, and detecting a current corresponding to the blood cell amount, and

wherein the measured blood component amount is corrected based on at least a part of the plurality of blood component amounts measured and the plurality of blood cell amounts measured.

12. The method for measuring a blood component according to claim 11, comprising:

referring to record data including a plurality of blood component amounts and a plurality of blood cell amounts that are converted from the respective currents detected more than once within the predetermined period for each blood with a known blood component amount and a known blood cell amount stored in a storage means;

comparing (i) the record data including a blood component amount that is closely approximated to any blood component amount of the plurality of blood component amounts measured and the plurality of blood cell amounts measured with (ii) measured data including the plurality of blood component amounts measured and the plurality of blood cell amounts measured; and

correcting the measured blood component amount to the blood component amount of blood having the record data that is most closely approximated to the measured data.

13. The method for measuring a blood component according to claim 12, comprising:

comparing (i) any combination of a blood component amount and a blood cell amount in the plurality of blood component amounts measured and the plurality of blood cell amounts measured with (ii) the record data including the same combination of a blood component amount and a blood cell amount in the plurality of blood component amounts and the plurality of blood cell amounts stored in the storage means; and

correcting the measured blood component amount to the blood component amount of blood having the most approximate record data.

14. The method for measuring a blood component according to claim 12, comprising:

measuring the blood component amount in a first period included in a first half of the predetermined period and in a second period included in a second half of the predetermined period.

15. The method for measuring a blood component according to claim 14, comprising:

measuring the blood component amount at least in a first period of the predetermined period during which a change in temperature of the blood introduced into the biosensor is large and in a second period of the predetermined period during which a change in temperature of the blood introduced into the biosensor is stable.

16. The method for measuring a blood component according to claim 14, comprising:

measuring the blood cell amount at least in the first period and in the second period.

17. The method for measuring a blood component according to claim 14, wherein the record data and the measured data include a group of the blood component amount measured in the first period and the blood cell amount measured in the first period, a group of the blood component amount measured in the first period and the blood cell amount measured in the second period, a group of the blood component amount measured in the second period and the blood cell amount measured in the first period, and a group of the blood component amount measured in the second period and the blood cell amount measured in the second period, and

wherein the blood component amount is corrected by comparing the same group between the record data and the measured data.

18. The method for measuring a blood component according to claim 11, comprising:

referring to record data including a plurality of blood component amounts and a plurality of blood cell amounts that are converted from the respective currents detected more than once within the predetermined period for each blood with a known blood component amount and a known blood cell amount and for each ambient temperature stored in a storage means;

detecting an ambient temperature;

extracting record data with a temperature closer to the detected ambient temperature, and comparing the extracted record data with measured data including the plurality of blood component amounts measured and the plurality of blood cell amounts measured; and

correcting the measured blood component amount to the blood component amount of blood having the record data that is most closely approximated to the measured data.

19. The method for measuring a blood component according to claim 11, comprising:

performing a multivariate analysis with the use of at least a part of the plurality of blood component amounts and the plurality of blood cell amounts to correct the blood component amount measured within the predetermined period.

20. The method for measuring a blood component according to claim 11, wherein the second voltage is applied to the second electrode pair only at the timing of the measurement of the blood cell amount in the predetermined period while the first voltage is being applied to the first electrode pair.