ELECTROCHEMICAL SENSOR, LANCET, AND BODILY FLUID MEASURING APPARATUS

• US 20120109010A1
• Filed: 10/28/2011
• Published: 05/03/2012
• Est. Priority Date: 10/29/2010
• Status: Active Grant

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Sato, Yoshiharu, Yamaguchi, Tadao, Watanabe, Shinichi, Matsuura, Yoshimitsu
• Granted Patent: US 9,351,676 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/1411 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 5/1468 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 5/150358 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 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15115 Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

An electrochemical sensor includes a base plate provided with a concave part formed on one of surfaces thereof, a fluid channel formed so that a bottom part of the concave part and the other one of the surfaces of the base plate are communicated with each other, a plurality of electrodes formed on the concave part; a reagent fixed on the electrodes, a cover which covers the concave part, and an air channel which causes the inside and outside of the concave part to be communicated with each other.

Claims

1. An electrochemical sensor, comprising:

a base plate provided with a concave part formed on one of surfaces thereof;

a fluid channel formed so that a bottom part of the concave part and the other one of the surfaces of the base plate are communicated with each other;

a plurality of electrodes formed on the concave part;

a reagent fixed on the electrodes;

a cover which covers the concave part; and

an air channel which causes the inside and outside of the concave part to be communicated with each other.

2. The electrochemical sensor according to claim 1, wherein an outer edge shape in planar view is a triangle, a trapezoid, or a circle.

3. The electrochemical sensor according to claim 1, wherein the fluid channel is a through-hole formed at the center of the concave part in planar view, and formed in a direction that is orthogonal to the base plate.

4. The electrochemical sensor according to claim 1, wherein the air channel includes at least one air hole formed in the cover.

5. The electrochemical sensor according to claim 4, wherein a planar view shape of the concave part is formed in a triangle, and

the air channel includes three air holes formed respectively at positions corresponding to apex portions of the triangle of the cover.

6. The electrochemical sensor according to claim 4, wherein a planar view shape of the concave part is formed in a circle, and

the air channel includes an air hole formed on the cover and disposed so as to overlap with the through-hole in a planar view state of the base plate.

7. The electrochemical sensor according to claim 1, further comprising:

a pair of second concave parts formed around the concave part,

wherein the plurality of electrodes include;

a first electrode pattern in which an electrode extending from the concave part to one of the pair of second concave parts and an electrode removal part are formed integrally; and

a second electrode pattern which is insulated from the first electrode pattern, and in which an electrode extending from the concave part to the other one of the pair of second concave parts and an electrode removal part are formed integrally.

8. The electrochemical sensor according to claim 1, wherein the other one of the surfaces of the base plate is recessed inward.

9. A lancet, comprising:

a lancet body;

a mounting part which is provided to the lancet body and to which an electrochemical sensor having one surface and the other surface is mounted in a state of the one surface facing the lancet body and the other surface facing outward; and

a puncture needle which can be freely advanced and retracted between a first position which is housed inside the lancet body and a second position which passes through the fluid channel of the electrochemical sensor mounted on the mounting part and protrudes from the other one of the surfaces,

the electrochemical sensor including;

a base plate provided with a concave part formed on one of surfaces thereof;

a fluid channel formed so that a bottom part of the concave part and the other one of the surfaces of the base plate are communicated with each other;

a plurality of electrodes formed on the concave part;

a reagent fixed on the electrodes;

a cover which covers the concave part; and

an air channel which causes the inside and outside of the concave part to be communicated with each other.

10. The lancet according to claim 9, wherein negative pressure for causing a fluid to flow from the other one of the surfaces to the one of the surfaces is applied to the fluid channel when a tip part of the puncture needle is retracted from the second position to the first position.

11. The lancet according to claim 9, wherein the electrochemical sensor is mounted on the mounted part in a state of becoming integral with the lancet body.

12. A bodily fluid measuring apparatus which is able to be equipped with a lancet, comprising:

a plurality of terminals which come in contact with the respective electrodes of the electrochemical sensor mounted on the lancet;

an electronic circuit which obtains a measurement signal via the plurality of terminals; and

a drive mechanism which advances and retracts the puncture tool,

the electrochemical sensor including;

a base plate provided with a concave part formed on one of surfaces thereof;

a fluid channel formed so that a bottom part of the concave part and the other one of the surfaces of the base plate are communicated with each other;

a plurality of electrodes formed on the concave part;

a reagent fixed on the electrodes;

a cover which covers the concave part; and

an air channel which causes the inside and outside of the concave part to be communicated with each other, and the lancet including;

a lancet body;

a mounting part which is provided to the lancet body and to which the electrochemical sensor is mounted in a state of the one of surfaces facing the lancet body and the other one of surfaces facing outward; and

a puncture needle which can be freely advanced and retracted between a first position which is housed inside the lancet body and a second position which passes through the fluid channel of the electrochemical sensor mounted on the mounting part and protrudes from the other one of the surfaces.