Method of measuring hematocrit (Hct), sensor used in the method, and measuring device

• US 8,480,869 B2
• Filed: 10/24/2011
• Issued: 07/09/2013
• Est. Priority Date: 12/04/2003
• Status: Active Grant

• Current Assignee: PHC Holdings Corporation
• Original Assignee: Panasonic Corporation (Panasonic Holdings Corporation)
• Inventors: Fujiwara, Masaki, Shinno, Teppei, Ikeda, Shin
• Primary Examiner(s): Ball, J. Christopher
• Assistant Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US13/279,787
• Publication Number:
  US 20120037506A1
• Time in Patent Office: 624 Days
• Field of Search: 204/409, 204400-40315, 205/777.5, 205/792, 205/775, 205/778, 600345-348, 422/68.1
• US Class Current: 204/403.12
• 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

The present invention provides a method of electrochemically measuring a hematocrit (Hct) value using a sensor, capable of achieving excellent measurement accuracy and reliability and also provides a sensor used in the method. The method of electrochemically measuring a hematocrit (Hct) value of blood include: providing an electrode system having a working electrode (11) and a counter electrode (12), in which a redox substance is provided on the counter electrode (12) but not on the working electrode (11); supplying blood to the electrode system; applying a voltage to the electrode system in this state to cause an oxidation current or a reduction current to flow between the working electrode (11) and the counter electrode (12); detecting the oxidation current or the reduction current; and determining a Hct value based on a value of the detected current.

Claims

1. A measuring device for measuring a Hct value of a blood sample, comprising:

a sensor;

a holder accepting the sensor;

a voltage source supplying a voltage to an electrode system of the sensor; and

a detector for detecting an oxidation current or a reduction current flowing through the electrode system of the sensor,

the sensor being a sensor for electrochemically measuring a hematocrit (Hct) value of blood, comprising;

an insulating substrate;

a cover disposed on the insulating substrate;

a spacer between the insulating substrate and the cover, defining a channel for leading a blood sample;

an electrode system having a working electrode and a counter electrode, both the working electrode and the counter electrode being partially exposed to the channel; and

a redox substance layer provided on the counter electrode but not on the working electrode,

wherein the part of the counter electrode exposed to the channel is entirely covered by the redox substance layer and no part of a working electrode is covered by the redox substance layer,

the device further comprising a calculator that calculates the Hct value based on the value of the current detected by the detector, and

a controller configured to direct the voltage source to supply the voltage to the electrode system of the sensor, and to communicate with the detector,

wherein the controller and the electrode system are configured so that, to measure the Hct value, a voltage is applied to the electrode system with blood present at the electrode system to cause an oxidation current that does not depend on the redox substance or a reduction current that does not depend on the redox substance to flow between the electrodes, and a value of the oxidation current or the reduction current is detected.

2. The device according to claim 1, wherein the working electrode and the counter electrode are disposed on the same insulating base material so as to be coplanar and spaced apart from each other.

3. The device according to claim 1,

wherein the working electrode is on an upstream side and the counter electrode is on a downstream side with respect to flow of the blood supplied from one end of the channel.

4. The device according to claim 1, wherein the redox substance comprises a redox substance that is in at least one of an oxidized state and a reduced state.

5. The device according to claim 1, wherein the redox substance is a ferricyanide.

6. The device according to claim 1, wherein the redox substance is potassium ferricyanide.

7. The device according to claim 1, wherein the redox substance is a ferrocyanide.

8. The device according to claim 1, wherein the redox substance is potassium ferrocyanide.

9. The device according to claim 1, wherein the working electrode on which the redox substance is not provided is coated with a polymeric material.

10. The device according to claim 1, wherein the working electrode on which the redox substance is not provided is coated with carboxymethylcellulose.

11. The device according to claim 1, wherein the applied voltage is equal to or higher than a voltage causing electrolysis of water.

12. The device according to claim 1, wherein the applied voltage is 1 to 10 V.

13. The device according to claim 1, wherein the applied voltage is 1 to 6.5 V.

14. The device according to claim 1, wherein

the redox substance is a ferrocyanide, and

a voltage that is negative with respect to a voltage applied to the counter electrode is applied to the working electrode.

15. The device according to claim 1,

Wherein one end of the channel communicates with the electrode system and the other end of the channel is open toward an outside of the sensor so as to serve as a blood supply port.

16. The device according to claim 1, wherein a crystal homogenizing agent further is provided on the electrode system.

17. The measuring device according to claim 1,

wherein a voltage supplied by the voltage source is equal to or higher than a voltage causing electrolysis of water.

18. The device according to claim 1, wherein the voltage source applies the voltage for a period in the range of from 0.01 to 10 seconds.

19. The device according to claim 18, wherein the period is in the range of from 0.01 to 5 seconds.