Analyzing instrument

• US 8,425,841 B2
• Filed: 10/12/2010
• Issued: 04/23/2013
• Est. Priority Date: 07/27/2001
• Status: Active Grant

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Katsuki, Koji, Sakata, Tetsuya, Shiraki, Yasunori
• Primary Examiner(s): Mui, Christine T
• Application Number:
  US12/902,647
• Publication Number:
  US 20110060203A1
• Time in Patent Office: 924 Days
• Field of Search: 422/68.1, 422/50, 600/345, 600/309, 600/300
• US Class Current: 422/68.1
• 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 5/150221 Valves
• 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• 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: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0809 rectangular shaped
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2300/10 Means to control humidity and/or other gases
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

The present invention relates to an analyzing instrument (X1) provided with a capillary (5) for moving a sample liquid. The analyzing instrument (X1) includes a dehumidification region for maintaining a constant moisture content in the capillary (5). Preferably, the dehumidification region has a hygroscopicity of no less than 2%. Preferably, at least part of an inner surface of the capillary (5) extends in the moving direction of the sample liquid and is a water-insoluble high-wettability region having a wettability of no less than 57 mN/m. The dehumidification region and the high-wettability region may be made of Vinylon, for example. Preferably, the analyzing instrument (X1) includes a liquid pooling portion (4) communicating with the capillary (5) and having a portion wider than the capillary (5).

Claims

1. A test instrument, comprising:

a substrate;

a plurality of electrodes on the substrate;

a cover;

one or more spacing members arranged between the substrate and the cover; and

a sample chamber defined between the cover and the substrate at top and bottom, the one or more spacing members defining sidewalls of the sample chamber, the sample chamber extending inwardly from an opening at an edge of the test instrument, the sidewalls of the one or more spacing members extending continuously from the opening to the plurality of electrodes, the sample chamber having a first portion and a second portion, the first portion located adjacent the opening and defined by tapered and curved sidewalls, the cover and the substrate, the second portion located inward of the first portion, the second portion of the sample chamber having a reagent and a smaller width than the first portion, and a vent from the second portion to outside of the test instrument,

wherein the reagent is between the opening of the test instrument and the vent such that a sample of blood is drawn by capillary action from the opening of the test instrument to the reagent portion.

2. The test instrument of claim 1, wherein the substrate is formed with a cutout defining the opening for the first portion of the sample chamber.

3. The test instrument of claim 1, wherein the cover is formed with a cutout defining the opening for the first portion of the sample chamber.

4. The test instrument of claim 1, wherein the sidewalls of the one or more spacing members are concave in the first portion of the sample chamber.

5. The test instrument of claim 1, wherein the sample chamber further comprises a cross-section that decreases in the first portion of the sample chamber and is substantially unchanged in the second portion of the sample chamber.

15. The test instrument of claim 1, wherein the sample chamber further comprises an angled transition portion at the intersection of the first and the second portions of the sample chamber.

20. The test instrument of claim 1, wherein the electrodes adjacent to the reagent are substantially parallel to the opening.

23. The test instrument of claim 1, wherein the sidewalls of the first portion are continuously curved from the opening to the second portion.

6. A test strip, comprising:

a substrate including electrodes thereon;

a cover;

at least one spacing member arranged between the substrate and the cover and forming walls therebetween;

a chamber defined between the cover, the substrate, and the walls of the at least one spacing member, the chamber having one or more receiving portions for transferring a sample of blood from a sample opening port at an outside edge of the test strip to the electrodes, the one or more receiving portions including at least a first component and a second component, the first component located adjacent the sample opening port and extending inward to the second component; and

a vent from the second component to outside of the test strip,

wherein the walls of the at least one spacing member define sides of the chamber and extend from the sample opening port to the electrodes, the sides of the first component being defined by tapered and curved walls of the at least one spacing member, the second component of the chamber having a reagent portion and a smaller cross-sectional area than the cross-sectional area of the first component of the chamber, the reagent portion is between the sample opening port of the test strip and the vent such that a sample of blood moves from the opening port of the test strip to the reagent portion by capillary action.

7. The test strip of claim 6, wherein the sides of the chamber are concave in the first component of the sample chamber.

8. The test strip of claim 6, wherein the chamber further comprises an angled transition portion at the intersection of the first and the second components of the sample receiving chamber.

9. The test strip of claim 6, wherein the sample opening port has an arched receiving portion.

16. The test strip of claim 6, wherein the substrate is formed with a cutout defining the opening for the first component of the chamber.

17. The test strip of claim 6, wherein the cover is formed with a cutout defining the opening for the first component of the chamber.

21. The test strip of claim 6, wherein the electrodes adjacent to the reagent portion are substantially parallel to the sample opening port.

24. The test strip of claim 6, wherein the sides of the first component are defined by continuously curved walls.

10. A test strip for receiving a blood sample, comprising:

a cover;

a substrate;

a plurality of electrodes;

a spacing member located between the cover and the substrate;

a sample chamber defined by inner surfaces of the cover, the substrate, and the spacing member;

the sample chamber having an outer portion and an inner portion;

an opening at an edge of the test strip formed by the cover, the substrate and the spacing member at the outer chamber portion, the spacing member having curved and tapered inner surfaces in the outer chamber portion and extending from about the opening at the outer chamber portion to the inner chamber portion where a reagent portion and the electrodes are located; and

a vent from the inner chamber portion to outside of the test strip,

wherein a width of the outer chamber portion at the opening being wider than a width of the inner chamber portion, and the reagent portion is between the opening of the test strip and the vent such that the blood sample is drawn by capillary action from the opening of the test strip to the reagent portion.

11. The test strip of claim 10, wherein the inner surfaces of the spacing member are concave in the outer chamber portion of the sample chamber.

12. The test strip of claim 10, wherein the sample chamber further comprises an angled transition portion at the intersection of the inner and outer portions of the sample chamber.

13. The test strip of claim 10, wherein the sample chamber further comprises a cross-section that decreases in the outer portion and is substantially unchanged in the inner portion.

14. The test strip of claim 10, wherein the sample chamber further comprises a cross-section that variably decreases in the outer portion and is substantially unchanged in the inner portion.

18. The test strip of claim 10, wherein the substrate is formed with a cutout defining the opening for the outer chamber portion of the sample chamber.

19. The test strip of claim 10, wherein the cover is formed with a cutout defining the opening for the outer chamber portion of the sample chamber.

22. The test strip of claim 10, wherein the electrodes adjacent to the reagent portion are substantially parallel to the opening.

25. The test strip of claim 10, wherein the inner surfaces in the outer chamber portion are continuously curved from the opening to the inner chamber portion.

26. An analyzing instrument to measure a concentration of a sample liquid, comprising:

a cover;

a substrate;

a plurality of electrodes on the substrate;

a spacing member located between the cover and the substrate; and

a sample liquid chamber defined by inner surfaces of the cover, the substrate, and the spacing member,

a sample port of the sample liquid chamber defined at an outside edge of the analyzing instrument, the sample port at an outer portion of the sample liquid chamber having a width that is wider than a width at an inner portion of the sample liquid chamber, the sample liquid chamber having a curved, tapered portion in the outer portion, the spacing member extending from the sample port of the sample liquid chamber to the inner portion of the sample liquid chamber where a reagent and the electrodes are located, and a vent from the inner portion of the sample liquid chamber to outside of the analyzing instrument,

wherein the reagent is located between the sample port and the vent such that the sample liquid is drawn by capillary action from the sample port to the reagent.

27. The analyzing instrument of claim 26, wherein the inner surfaces of the spacing member are concave in the outer portion of the sample liquid chamber.

28. The analyzing instrument of claim 26, wherein the sample liquid chamber further comprises a cross-section that decreases in the outer portion of the sample liquid chamber and is substantially unchanged in the inner portion of the sample liquid chamber.

29. The analyzing instrument of claim 26, wherein the sample liquid chamber further comprises an angled transition portion at the intersection of the outer and the inner portions of the sample liquid chamber.

30. The analyzing instrument of claim 26, wherein the inner surfaces of the spacing member in the outer portion are continuously curved from the sample port to the inner portion.