Biosensor, cartridge storing biosensor, measurement device using biosensor

• US 10,107,808 B2
• Filed: 06/20/2011
• Issued: 10/23/2018
• Est. Priority Date: 06/23/2010
• Status: Active Grant

• Current Assignee: PHC Holdings Corporation
• Original Assignee: PHC Holdings Corporation
• Inventors: Fujiwara, Masaki
• Primary Examiner(s): Siefke, Samuel P
• Application Number:
  US13/642,243
• Publication Number:
  US 20130035573A1
• Time in Patent Office: 2,682 Days
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• 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 5/150061 Means for enhancing collection
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• 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 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• 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 33/5438 Electrodes

Abstract

There are provided a biosensor, and a measurement device in which the biosensor is used, with which accurate puncture is enabled and reliability of measurement results are improved. The biosensor comprises an element substrate, a detector, a connection terminal, a continuity path, and a cutout. The detector is provided over the element substrate, and receives a specimen and detects a specific component contained in the specimen. The connection terminal is provided over the element substrate and acquires current corresponding to the specific component. The continuity path connects the connection terminal and the detector. The cutout is formed along the outer periphery of the detector so as to surround two or more directions of the detector.

Claims

1. A biosensor, comprising:

an element substrate including a lower plate, a middle plate laminated over the lower plate, and an upper plate laminated over the middle plate;

a detector configured to receive a specimen and detect a specific component contained in the specimen;

a connection terminal provided over the element substrate and configured to acquire current corresponding to the specific component;

a continuity path arranged to connect the connection terminal and the detector;

a cutout formed on the lower plate, the middle plate and the upper plate respectively and along an outer periphery of the detector so as to surround two or more directions of the detector, and

a non-cutout part formed on the lower plate, the middle plate, and the upper plate respectively,

wherein the detector is formed within the cutout on the element substrate and bends upward, and

a width of the non-cutout part formed on the middle plate and the upper plate respectively is narrower than a width of the non-cutout part formed on the lower plate.

2. The biosensor according to claim 1,

wherein the detector has:

a puncture component configured to acquire the specimen by insertion of a needle;

a reaction component configured to generate current corresponding to the specific component in the specimen; and

a specimen supply route linking the puncture component and the reaction component.

3. The biosensor according to claim 1,

wherein the cutout is formed continuously so as to surround the detector except for a pull-out portion of the continuity path.

4. The biosensor according to claim 3,

wherein the cutout is elliptical or circular in a plan view of the biosensor.

5. The biosensor according to claim 1,

wherein the cutout is linear and is formed so as to surround four sides of the detector.

6. The biosensor according to claim 5,

wherein the cutout is formed in a fork shape in a plan view of the biosensor in at least one of the long-side direction and the short-side direction of the biosensor.

7. The biosensor according to claim 2,

wherein the puncture component is disposed in an approximate center of the detector.

8. The biosensor according to claim 2,

wherein the puncture component is disposed offset by a specific distance from a center of the detector, and

the specific distance is set on the basis of a distance from a center of a bulging part of a finger when the finger has been placed against the puncture component, to an end edge of the detector.

9. The biosensor according to claim 2,

wherein the element substrate includes a lower plate and an upper plate laminated over the lower plate,

the reaction component, the continuity path, and the connection terminal are provided on the lower plate, and

the specimen supply route is provided between the lower plate and the upper plate.

10. The biosensor according to claim 9,

wherein the cutout is formed continuously so as to surround the detector except for a pull-out portion for the continuity path, and

the pull-out portion formed on the upper plate has a width that is narrower than the pull-out portion for the continuity path formed on the lower plate.

11. The biosensor according to claim 9,

wherein the puncture component includes a through-component formed over the lower plate, and a non-through-component formed in a portion of the upper plate corresponding to the through-component.

12. The biosensor according to claim 2,

wherein the element substrate includes a lower plate, a middle plate laminated over the lower plate, and an upper plate laminated over the middle plate,

the reaction component, the continuity path, and the connection terminal are provided on the lower plate, and

the specimen supply route is provided on the middle plate.

13. The biosensor according to claim 12,

wherein the cutout is formed continuously so as to surround the detector except for a pull-out portion for the continuity path, and

the pull-out portion formed on each of the upper plate and the middle plate has a width that is narrower than the pull-out portion for the continuity path formed on the lower plate.

14. The biosensor according to claim 12,

wherein the puncture component includes a through-component formed on the lower plate and the middle plate respectively, and a non-through-component formed in the portion of the upper plate corresponding to the through-component.

15. The biosensor according to claim 1,

wherein the connection terminal has a plurality of electrodes that are provided to both sides of the detector in a short-side direction of the biosensor, the plurality of electrodes including at least a working electrode and a counter electrode.

16. The biosensor according to claim 15,

wherein the plurality of electrodes further includes a detecting electrode and an Hct electrode.

17. The biosensor according to claim 1, further comprising a non-cutout part to which the continuity path is provided.

18. The biosensor according to claim 1, further comprising

wherein the element substrate includes a lower plate and an upper plate laminated over the lower plate, and

the non-cutout part of the upper plate has narrower width than the non-cutout part of the lower plate.