Sensor chip, and measurement device and blood test device in which this sensor chip is used

• US 9,176,090 B2
• Filed: 03/17/2010
• Issued: 11/03/2015
• Est. Priority Date: 04/07/2009
• Status: Active Grant

• Current Assignee: PHC Holdings Corporation
• Original Assignee: Panasonic Healthcare Holdings Co., Ltd.
• Inventors: Fujiwara, Masaki
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): FISHER, BRITTANY I
• Application Number:
  US13/258,641
• Publication Number:
  US 20120010486A1
• Time in Patent Office: 2,057 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150274 Manufacture or production processes or steps for blood sampling devices
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15134 Bladeless capillary blood sampling devices, i.e. devices for perforating the skin in order to obtain a blood sample but not using a blade, needle, canula, or lancet, e.g. by laser perforation, suction or pressurized fluids
• CPC Class Codes: A61B 5/15138 provided with means to ensure the protection of the user, e.g. to avoid laser light entering the eyes of a user
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 2035/1062 for testing the liquid while it is in the transfer device
• CPC Class Codes: G01N 2400/00 Assays, e.g. immunoassays or enzyme assays, involving carbohydrates
• CPC Class Codes: G01N 27/26 by investigating electrochemical variables; by using electrolysis or electrophoresis
• CPC Class Codes: G01N 27/283 Means for supporting or introducing electrochemical probes
• CPC Class Codes: G01N 27/307 Disposable laminated or multilayered electrodes G01N27/3272 takes precedence
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/4166 : measuring a particular property of an electrolyte
• CPC Class Codes: G01N 33/49 : Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 35/1016 : Control of the volume dispensed or introduced

Abstract

This sensor chip (11) comprises a substrate (15) in the form of a flat board, a sample inlet (20) that is provided in the thickness direction of the substrate (15) and into which flows the blood (3) used for measurement, a supply path (21) that communicates with this sample inlet (20), and detection electrodes (17, 18, 19) provided to this supply path (21), wherein the substrate (15) is provided with a surplus blood reservoir (25) that draws in surplus blood (3a) and holds this drawn surplus blood (3a).

Claims

1. A sensor chip for analyzing components of a biological sample, the sensor chip comprising:

a substrate;

a sample inlet provided to the substrate, said sample inlet configured to receive a part of the biological sample;

a supply path provided to the substrate and being connected to the sample inlet, said supply path configured to receive the part of the biological sample from the sample inlet;

detection electrodes provided to the supply path, said detection electrodes being configured to detect signals used for analysis of the part of the biological sample; and

a surplus blood reservoir provided to the substrate and not being connected to the supply path, said surplus blood reservoir configured to hold a surplus of the biological sample, the surplus of the biological sample not including the part of the biological sample from which signals used for analysis are detected by the detection electrodes,

wherein the substrate has a surplus blood inlet that is provided to an end of the substrate, the surplus of the biological sample being provided to the surplus blood inlet,

wherein the surplus blood inlet draws the surplus of the biological sample into the surplus blood reservoir by capillary action,

wherein the sample inlet is provided to one end face of the substrate, and

wherein the surplus blood inlet is provided to an end face of the substrate that is different side from the end face where the sample inlet is provided.

2. The sensor chip according to claim 1,

wherein the surplus blood reservoir has an opening on one or more faces of the substrate.

3. The sensor chip according to claim 1,

wherein the volume of the surplus blood reservoir is greater than the volume of the supply path.

4. The sensor chip according to claim 1,

wherein the volume of the surplus blood reservoir is no more than two thirds the volume of the substrate.

5. The sensor chip according to claim 1,

wherein a plurality of the surplus blood inlets are provided.

6. The sensor chip according to claim 5,

wherein the surplus blood inlets are disposed symmetrically in reference to the lengthwise center line of the substrate.

7. The sensor chip according to claim 5,

wherein the plurality of surplus blood inlets that are provided are disposed at mutually adjacent locations.

8. The sensor chip according to claim 1,

wherein a plurality of the surplus blood reservoirs are provided.

9. The sensor chip according to claim 8,

wherein the plurality of surplus blood reservoirs that are provided are disposed symmetrically in reference to the lengthwise center line of the substrate.

10. The sensor chip according to claim 8,

wherein the plurality of surplus blood reservoirs are formed in the same shape as one another.

11. The sensor chip according to claim 8,

wherein the plurality of surplus blood reservoirs are formed in mutually different shapes.

12. The sensor chip according to claim 1,

wherein the supply path and the surplus blood reservoir are formed by the same member,

wherein the substrate is formed by laminating a base plate, a spacer, and a cover, and

wherein the supply path and the surplus blood reservoir are formed in the same layer.

13. The sensor chip according to claim 12,

wherein the supply path and the surplus blood reservoir are formed as respective separate spaces by the spacer.

14. The sensor chip according to claim 1,

wherein the supply path and the surplus blood reservoir are formed in different layers, and

wherein the substrate is formed by laminating a base plate, a spacer, a cover, and a surplus blood suction spacer.

15. The sensor chip according to claim 14,

wherein the supply path and the surplus blood reservoir are formed by separate members.

16. The sensor chip according to claim 1,

wherein a plurality of bumps are provided on the inside of the surplus blood reservoir.

17. The sensor chip according to claim 1,

wherein the substrate has a surplus blood detection electrode that detects blood that has flowed into the surplus blood reservoir.

18. The sensor chip according to claim 1,

wherein the sample inlet is provided to a first edge side of the substrate, and

wherein the surplus blood inlet is provided to a second edge on the sample inlet side.

19. The sensor chip according to claim 1,

wherein the sample inlet is provided to a first edge side of the substrate,

wherein the surplus blood inlet is provided to a second edge on the sample inlet side, and

wherein a plurality of bumps are formed on the inside of the surplus blood reservoir.

20. The sensor chip according to claim 1,

wherein the surplus blood inlet is provided on a first edge side of the substrate, and

wherein a measurement blood inlet is provided on a second edge side of the substrate.

21. The sensor chip according to claim 1,

wherein the surplus blood inlet is provided to an entire first edge of the substrate, and

wherein the sample inlet is provided in the approximate center of a second edge of the substrate.

22. The sensor chip according to claim 1,

wherein the surplus blood inlet is provided to an entire first edge of the substrate,

wherein a plurality of bumps are formed on the inside of the surplus blood reservoir, and

wherein there is further provided a supply path that passes through the substrate in between two opposite edges.

23. The sensor chip according to claim 1,

wherein the substrate has a substantially rectangular shape,

wherein the sample inlet is provided to a first short side of the substantially rectangular shape, and

wherein the surplus blood reservoir is a surplus blood suction member that is affixed to the upper or lower face of the substrate.

24. The sensor chip according to claim 1,

wherein the surplus blood inlet and its surrounding portion are given a water repellency treatment or formed by a water-repellent member.

25. The sensor chip according to claim 1,

wherein the volume of the surplus blood reservoir is at least three times greater than the volume of the supply path.

26. The sensor chip according to claim 1,

wherein the part of the biological sample received by the sample inlet is provided to the sample inlet separately from the surplus of the biological sample provided to be held by the surplus blood reservoir.

27. The sensor chip according to claim 1,

wherein the part of the biological sample received by the sample inlet is provided to the sample inlet separately from the surplus of the biological sample provided to surplus blood inlet.

28. The sensor chip according to claim 1,

wherein the substrate is formed by laminating a base plate, a spacer, and a cover,

wherein the spacer includes a slit, the slit forming the supply path,

wherein the spacer includes a pair of cut-outs, the pair of cut-outs forming the surplus blood reservoir,

wherein the slit is formed at a first edge side of the spacer, and

wherein the pair of cut-outs are formed at a second edge side of the spacer and a third edge side of the spacer, respectively, the second edge side and the third edge side being opposite edge sides of the spacer and being different than the first edge side.

29. A sensor chip for analyzing components of a biological sample, the sensor chip comprising:

a substrate;

a sample inlet provided to the substrate, said sample inlet configured to receive a part of the biological sample;

a supply path provided to the substrate and being connected to the sample inlet, said supply path configured to receive the part of the biological sample from the sample inlet;

detection electrodes provided to the supply path, said detection electrodes being configured to detect signals used for analysis of the part of the biological sample; and

a surplus blood reservoir provided to the substrate and not being connected to the supply path, said surplus blood reservoir configured to hold a surplus of the biological sample, the surplus of the biological sample not including the part of the biological sample from which signals used for analysis are detected by the detection electrodes,

wherein the substrate is formed by laminating a base plate, a spacer, a cover, a surplus blood suction spacer, and a surplus blood suction cover.

30. A measurement device, comprising:

a housing;

a sensor insertion portion that is provided to part of the housing and into which a sensor chip is inserted;

a connector that is provided to the sensor insertion portion;

a measurement circuit that is connected to the connector; and

a display component that is connected to the output of the measurement circuit and displays the result of measuring analysis data for a biological sample introduced to the sensor chip and measured with the measurement circuit,

wherein the sensor chip includes;

a substrate;

a sample inlet provided to the substrate, said sample inlet configured to receive a part of the biological sample;

a supply path provided to the substrate and being connected to the sample inlet, said supply path configured to receive the part of the biological sample from the sample inlet;

detection electrodes provided to the supply path, said detection electrodes being configured to detect signals used for analysis of the part of the biological sample;

a surplus blood reservoir provided to the substrate and not being connected to the supply path, said surplus blood reservoir configured to hold a surplus of the biological sample, the surplus of the biological sample not including the part of the biological sample from which signals used for analysis are detected by the detection electrodes; and

a surplus blood detection electrode that detects blood that flows into the surplus blood reservoir, and

wherein there is further provided a terminal for the surplus blood detection electrode, the terminal being provided to the connector and detecting that surplus blood has been drawn into the sensor chip.

31. The measurement device according to claim 30,

wherein the terminal for the surplus blood detection electrode also serves as the terminal for some or all of the connection terminals that connect to the detection electrodes used for analysis.

32. A blood test device, comprising:

a housing;

a sensor insertion portion that is provided to part of the housing and into which a sensor chip is inserted;

puncture component configured to puncture the skin, provided at or near a location that is opposite the sensor insertion portion;

a connector that is provided to the sensor insertion portion;

an electrical circuit that is connected to the connector and performs analysis of a biological sample; and

a display component that is connected to the output of the electrical circuit,

wherein the sensor chip includes;

a substrate;

a sample inlet provided to the substrate, said sample inlet configured to receive a part of the biological sample;

a supply path provided to the substrate and being connected to the sample inlet, said supply path configured to receive the part of the biological sample from the sample inlet;

detection electrodes provided to the supply path, said detection electrodes being configured to detect signals used for analysis of the part of the biological sample;

a surplus blood reservoir provided to the substrate and not being connected to the supply path, said surplus blood reservoir configured to hold a surplus of the biological sample, the surplus of the biological sample not including the part of the biological sample from which signals used for analysis are detected by the detection electrodes; and

a surplus blood detection electrode that detects blood that has flowed into the surplus blood reservoir, and

wherein there is further provided a surplus blood detection circuit that performs detection of surplus blood taken into the sensor chip.

33. A sensor chip for analyzing components of a biological sample, the sensor chip comprising:

a substrate;

a sample inlet provided to the substrate, said sample inlet configured to receive a part of the biological sample;

a supply path provided to the substrate and being connected to the sample inlet, said supply path configured to receive the part of the biological sample from the sample inlet;

detection electrodes provided to the supply path, said detection electrodes being configured to detect signals used for analysis of the part of the biological sample; and

a surplus blood reservoir provided to the substrate and not being connected to the supply path, said surplus blood reservoir configured to hold a surplus of the biological sample, the surplus of the biological sample not including the part of the biological sample from which signals used for analysis are detected by the detection electrodes,

wherein the substrate is formed by laminating a base plate, a spacer, a cover, a surplus blood suction spacer, and a surplus blood suction cover,

wherein the spacer includes a slit, the slit forming the supply path,

wherein the surplus blood suction spacer includes a pair of cut-outs, the pair of cut-outs forming the surplus blood reservoir, and

wherein the spacer and the surplus blood suction spacer are separated by the cover.