Analyzing instrument

• US 7,824,616 B2
• Filed: 07/26/2002
• Issued: 11/02/2010
• Est. Priority Date: 07/27/2001
• Status: Expired due to Fees

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Sakata, Tetsuya, Shiraki, Yasunori, Katsuki, Koji
• Primary Examiner(s): Griffin; Walter D
• Assistant Examiner(s): Ramdhanie; Bobby
• Application Number:
  US10/484,955
• Publication Number:
  US 20040197231A1
• Time in Patent Office: 3,021 Days
• Field of Search: 422/68.1
• 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. An analyzing instrument for receiving a sample of bodily fluid, comprising:

a substrate;

a cover over the substrate;

a spacing member between the substrate and the cover;

a plurality of electrodes formed on the substrate; and

a chamber defined between the cover and the substrate at top and bottom, the spacing member having first and second portions that define sidewalls of the chamber, the chamber extending inwardly in a direction substantially parallel to a plane of the substrate from an opening defined at an edge of the analyzing instrument to a position at which the plurality of electrodes are present on the substrate, the sidewalls being curved and extending from the opening to the plurality of electrodes, and having a height that is substantially equal to the thickness of the spacing member,

the opening having a top and bottom defined by respective edges of the substrate and the cover, the substrate and cover being substantially parallel at the position of the opening,

the chamber having a first section adjacent the opening and a second section inward of the first section that has a smaller width than the first section, the first section width defined by the curved sidewalls of the chamber,

the second section of the chamber having dimensions suitable for drawing sample liquid into the analyzing instrument so that sample liquid is delivered to the position at which the plurality of electrodes are present.

2. The analyzing instrument according to claim 1,

wherein at least a part of an inner surface of the chamber is a water-insoluble high-wettability region having a wettability of no less than 57 mN/m.

3. The analyzing instrument of claim 1,

wherein the dimensions of the chamber are suitable for sample liquid to be drawn into the analyzing instrument by capillary action.

4. The analyzing instrument of claim 1,

wherein the inner surface of the substrate or cover is substantially smooth.

5. The analyzing instrument of claim 1,

wherein the inner surfaces of the substrate, the cover, and the spacing member are substantially smooth.

6. The analyzing instrument of claim 5,

wherein the opening at the edge of the chamber serves as a sample introducing port.

7. The analyzing instrument of claim 6,

further comprising an opening in communication with the second section of the chamber that serves as a vent hole.

8. The analyzing instrument of claim 5,

wherein the edges of the substrate and the cover adjacent to the opening are substantially aligned with each other.

9. The analyzing instrument of claim 5,

wherein the edges of the substrate and the cover adjacent to the opening are substantially straight and substantially aligned with each other.

10. The analyzing instrument of claim 8,

wherein each of the cover, the substrate, and the spacing member is substantially flat.

11. The analyzing instrument of claim 9,

wherein at least one of the cover layer and the substrate is substantially flat.

12. The analyzing instrument of claim 1,

wherein the cover is substantially parallel to the substrate.

13. The analyzing instrument of claim 1,

wherein the substrate has an elongated structure.

14. The analyzing instrument of claim 8,

wherein the cover has a transparent or translucent portion.

15. The analyzing instrument of claim 9,

wherein the cover has a transparent or translucent portion, and the color of the sample liquid is different from the spacing member or the substrate.

16. The analyzing instrument of claim 1,

wherein the cover has a transparent or translucent portion, and the sample liquid is blood.

17. The analyzing instrument of claim 16,

wherein the electrodes have a substantially forked pattern.

18. The analyzing instrument of claim 1,

wherein the opening of the chamber has a width less than about 5 mm.

19. The analyzing instrument of claim 1,

wherein the opening of the chamber has a width less than about 3 mm.

20. The analyzing instrument of claim 1,

wherein the opening of the chamber has a height less than about 200 μ

m.

21. The analyzing instrument of claim 1,

wherein the opening of the chamber has a height larger than about 50 μ

m.

22. The analyzing instrument of claim 1,

wherein the opening of the chamber has a width between about 2 mm and about 5 mm, and a height between about 50 μ

m and about 200 μ

m.

23. An analyzing instrument for analyzing human sample liquids, comprising:

a substrate;

a plurality of electrodes formed on the substrate;

a cover over the substrate;

a spacing member between the substrate and the cover; and

a sample chamber defined between the cover and the substrate at top and bottom, the spacing member defining sidewalls of the sample chamber and having an opening defined at an edge of the analyzing instrument;

the sample chamber extending inwardly from an opening defined at an edge of the analyzing instrument, and the sample chamber having dimensions suitable for drawing sample liquids into the analyzing instrument,

the sample chamber having a first section adjacent the opening defined by curved sidewalls and a second section inward of the first section into the instrument having that has a smaller width than the first section, the sidewalls extending continuously from the opening to the electrodes.

24. 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; and

a sample liquid chamber defined by inner surfaces of the cover the substrate, and the spacing member, a width of an opening from the edge of the instrument, at a first end of the chamber being wider than a width at an inner portion of another end of the chamber, the chamber having a curved tapered portion adjacent to the opening, the spacing member extending from the opening of the chamber to the inner portion of the chamber where the electrodes are on the substrate.

25. An instrument for analyzing a sample of a bodily fluid, comprising:

a substrate with electrodes on the substrate;

a cover over the substrate;

at least one spacing member between the substrate and the cover extending from the edge of the instrument; and

a sample receiving chamber defined at top and bottom by the cover and the substrate and at its sides by sidewalls of the at least one spacing member, the sample receiving chamber extending inwardly from a first portion for receiving the sample of bodily fluid to a second portion where the electrodes are present, and the sidewalls extending from the first portion to the second portion and being curved in the first portion and substantially straight in the second portion.

26. The instrument of claim 25,

wherein the dimensions of the sample receiving chamber are suitable for fluid to be drawn into the analyzing instrument by capillary action.

27. The instrument of claim 26,

wherein the sidewalls are substantially concave at the first portion of the sample receiving chamber.

28. The instrument of claim 26,

wherein the sample receiving chamber further comprises an angled transition portion at the intersection of the first and second portions of the sample receiving chamber.

29. The instrument of claim 27,

wherein the sample receiving chamber further comprises a cross-section that decreases in the first portion and is substantially unchanged in the second portion.

30. The instrument of claim 27,

wherein the sample receiving chamber further comprises a cross-section that variably decreases in the first portion and is substantially unchanged in the second portion.

31. The instrument of claim 26,

wherein the edge of the instrument serves as a sample introducing port and the introducing port has an arched receiving portion.

32. The instrument of claim 31,

wherein the second portion of the sample receiving chamber further comprises a vent in communication with the sample receiving chamber.