Electrochemical sensor, lancet, and bodily fluid measuring apparatus

• US 9,351,676 B2
• Filed: 10/28/2011
• Issued: 05/31/2016
• Est. Priority Date: 10/29/2010
• Status: Active Grant

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Yamaguchi, Tadao, Sato, Yoshiharu, Watanabe, Shinichi, Matsuura, Yoshimitsu
• Primary Examiner(s): HENSON, DEVIN B
• Application Number:
  US13/284,071
• Publication Number:
  US 20120109010A1
• Time in Patent Office: 1,677 Days
• Field of Search: 600/583, 600/573, 604/313, 156/106, 204/400, 204/403.14
• US Class Current: 1/1
• 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 having a top surface and a bottom surface opposite of the top surface, the base plate includes a top concave part formed on the top surface;

a fluid channel formed in the base plate, the fluid channel being a through-hole formed at a center of the top concave part in planar view, and formed in a direction that is orthogonal to the base plate to communicate a bottom part of the top concave part with the bottom surface opposite of the bottom part of the top concave part;

a plurality of electrodes formed on the top concave part;

a reagent fixed on the electrodes, having a ring-shape and disposed such that an inner edge of the ring-shape surrounds an opening of the through-hole;

a cover which is directly provided on the base plate on which the plurality of electrodes are formed and is adapted to cover the top concave part; and

an air channel disposed on the cover adapted to provide communication between an inside space existing between the top surface of the top concave part and the cover and an outside space above the cover.

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

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

4. The electrochemical sensor according to claim 3, wherein a planar view shape of the top 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 top concave part.

5. The electrochemical sensor according to claim 3, wherein a planar view shape of the top concave part is formed in a circle, and

the air channel includes said at least one air hole formed on the cover and disposed so as to overlap with the fluid channel in a planar view state of the base plate.

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

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

wherein the plurality of electrodes include;

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

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

the cover has through-holes corresponding to positions of the second concave parts; and

terminals for charging voltage to electrodes are inserted into the second concave parts through the through-holes of the cover.

7. The electrochemical sensor according to claim 1, wherein the bottom surface of the base plate is recessed inward.

8. The electrochemical sensor according to claim 1, wherein one of the plurality of electrodes is formed to at least partially surround the through-hole.

9. A lancet, comprising:

a lancet body;

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

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

the electrochemical sensor including;

a base plate provided with a top concave part formed on a top surface thereof;

a fluid channel formed in the base plate, the fluid channel being a through-hole formed at a center of the top concave part in planar view, formed in a direction that is orthogonal to the base plate, and adapted to be a communication channel between a bottom part of the top concave part and a bottom surface of the base plate opposite of the bottom part of the top concave part;

a plurality of electrodes formed on the top concave part;

a reagent fixed on the electrodes, having a ring-shape, and disposed such that an inner edge of the ring-shape surrounds an opening of the through-hole;

a cover which is directly provided on the base plate on which the plurality of electrodes are formed and covers the top concave part; and

an air channel disposed on the cover adapted to provide communication between an inside space existing between the top surface of the top concave part and the cover and an outside space above the cover.

10. The lancet according to claim 9, wherein negative pressure for causing a fluid to flow from the bottom surface to the top surface of the base plate via the fluid channel in the base plate 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 mounting part in a state of becoming integral with the lancet body.

12. The lancet according to claim 9, wherein one of the plurality of electrodes is formed to at least partially surround the through-hole.

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

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

an electronic circuit adapted to obtain a measurement signal via the plurality of terminals; and

a drive mechanism adapted to advance and retract a puncture tool,

the electrochemical sensor including;

a base plate provided with a top concave part formed on a top surface thereof;

a fluid channel formed in the base plate, the fluid channel being a through-hole formed at the center of the top concave part in planar view, formed in a direction that is orthogonal to the base plate, and adapted to be a communication channel between a bottom part of the top concave part and the bottom surface opposite of the bottom part of the top concave part;

a plurality of electrodes formed on the top concave part;

a reagent fixed on the electrodes, having a ring-shape and disposed such that an inner edge of the ring-shape surrounds an opening of the through-hole;

a cover which is directly provided on the base plate on which the plurality of electrodes are formed and is adapted to cover the top concave part; and

an air channel disposed on the cover and adapted to provide communication between an inside space existing between the top surface of the top concave part and the cover and an outside space above the cover, 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 top concave part facing the lancet body and the bottom surface facing outward; and

a puncture needle configured to 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 one of the top and bottom surfaces.

14. The bodily fluid measuring apparatus according to claim 13, wherein one of the plurality of electrodes is formed to at least partially surround the through-hole.