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

• US 9,513,249 B2
• Filed: 12/22/2015
• Issued: 12/06/2016
• 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
• Application Number:
  US14/978,158
• Publication Number:
  US 20160153926A1
• Time in Patent Office: 350 Days
• Field of Search: 422/419
• 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 the components of a biological sample, comprising:

a substrate in the form of a flat board, and that is formed at least by laminating a base plate, a spacer, and a cover;

a sample inlet that is provided to one end of the substrate, into which flows the biological sample used for analysis;

a supply path that communicates with the sample inlet and into which the biological sample is introduced;

detection electrodes that are provided to the supply path and detect signals used for analysis; and

a surplus blood reservoir that is provided to the substrate and into which extra blood not used for analysis is drawn and held,

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

2. 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.

3. 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.

4. The sensor chip according to claim 1,

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

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

5. The sensor chip according to claim 4,

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

6. The sensor chip according to claim 1,

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

7. 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.

8. The sensor chip according to claim 1,

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.

9. The sensor chip according to claim 1,

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

wherein a 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.

10. The sensor chip according to claim 1,

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

11. 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.

12. 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.

13. The sensor chip according to claim 1,

wherein the supply path has a first air hole that communicates with the outside air and is provided to a location that is opposite the sample inlet side.

14. The sensor chip according to claim 1,

wherein the surplus blood reservoir has a second air hole that communicates with the outside air and is provided in order to draw in surplus blood.

15. A measurement device, comprising:

a housing;

a sensor insertion portion that is provided to part of the housing and into which the sensor chip according to claim 1 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.

16. A method for analyzing the components of a biological sample, the method comprising:

introducing the biological sample to the sensor chip according to claim 1 so as to produce a current proportional to a blood glucose concentration in the biological sample; and

converting the current to digital data, and displaying the digital data.