Test instrument, attachment, and concentration measuring apparatus

• US 7,640,047 B2
• Filed: 09/06/2002
• Issued: 12/29/2009
• Est. Priority Date: 09/11/2001
• Status: Expired due to Fees

• Current Assignee: ARKRAY, Inc
• Original Assignee: ARKRAY, Inc
• Inventors: Kusaka, Yasuhide, Matsumoto, Daisuke, Sakata, Tetsuya
• Primary Examiner(s): Mallari; Patricia C
• Assistant Examiner(s): Toth; Karen E
• Application Number:
  US10/489,397
• Publication Number:
  US 20040242982A1
• Time in Patent Office: 2,671 Days
• Field of Search: 600/345, 422/100, 422/102, 436/180, 204/403
• US Class Current: 600/345
• 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 5/1486 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• 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 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15123 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 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 2400/0694 : vents used to stop and induce flow, backpressure valves
• CPC Class Codes: B01L 3/502723 : characterised by venting arrangements
• CPC Class Codes: B01L 3/50273 : characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• 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 9/002 : using variation of the resonant frequency of an element vibrating in contact with the material submitted to analysis G01N9/34 takes precedence

Abstract

The present invention relates to a test instrument (X) including a capillary (5) for moving a sample liquid (B), a liquid pooling portion (4) communicating with the capillary (5) for retaining the sample liquid (B) to be introduced into the capillary (5), and a liquid introduction selector (12) for selecting whether or not the sample liquid (B) retained in the liquid pooling portion (4) is introduced into the capillary (5). The present invention also relates to an attachment provided with the test instrument (X), and a concentration measuring apparatus to which the attachment is mounted for use.

Claims

1. A test instrument comprising:

a capillary for moving a sample liquid;

a liquid pooling portion communicating with the capillary for retaining the sample liquid to be introduced into the capillary;

a liquid introduction selector for selecting whether or not the sample liquid retained in the liquid pooling portion is introduced into the capillary;

a detector for detecting whether or not an intended amount of sample liquid is supplied to the liquid pooling portion; and

a reagent portion provided in the capillary for dissolution upon supply of the sample liquid to the capillary, and a first measurement electrode and a second measurement electrode for applying a voltage to a reaction system formed by the reagent portion and the sample liquid;

wherein the detector includes a first detection electrode and a second detection electrode which are exposed to an inside of the liquid pooling portion at least partially, and whether or not an intended amount of sample liquid is supplied to the liquid pooling portion is determined by detecting whether or not electrical conduction through the sample liquid is provided between the first detection electrode and the second detection electrode,

wherein the first detection electrode is electrically connected to the first measurement electrode, the second detection electrode being electrically connected to the second measurement electrode.

2. The test instrument according to claim 1, further comprising:

a substrate; and

a cover for defining the capillary together with the substrate;

wherein the liquid pooling portion includes an introduction port communicating with the capillary for introducing the sample liquid;

wherein the introduction port is formed in the substrate; and

wherein the liquid pooling portion continuously penetrates the substrate and the cover thicknesswise,

wherein the liquid introduction selector includes a discharge port for discharging air from an inside of the capillary, the discharge port being provided at the substrate and opened away from the cover.

3. The test instrument according to claim 2, wherein the introduction port opens wider than an entrance of the capillary.

4. The test instrument according to claim 2, further comprising a close contact layer which is provided adjacent the introduction port and which is more adherent to skin than the substrate or the cover.

5. The test instrument according to claim 2, wherein the liquid pooling portion has an internal capacity which is generally equal to or larger than an internal capacity of the capillary.

6. An attachment for mounting to a concentration measuring apparatus for measuring concentration of a particular component in a sample liquid, the attachment being provided with a test instrument including a capillary for moving the sample liquid;

wherein the test instrument comprises a liquid pooling portion communicating with the capillary for retaining the sample liquid to be introduced into the capillary, a liquid introduction selector for selecting whether or not the sample liquid retained in the liquid pooling portion is introduced into the capillary, a detector for detecting whether or not an intended amount of sample liquid is supplied to the liquid pooling portion, a reagent portion provided in the capillary for dissolution upon supply of the sample liquid to the capillary, and first and second measurement electrodes for applying a voltage to a reaction system formed by the reagent portion and the sample liquid;

wherein the detector includes a first detection electrode and a second detection electrode which are exposed to an inside of the liquid pooling portion at least partially, and whether or not an intended amount of sample liquid is supplied to the liquid pooling portion is determined by detecting whether or not electrical conduction through the sample liquid is provided between the first detection electrode and the second detection electrode,

wherein the first detection electrode is electrically connected to the first measurement electrode, the second detection electrode being electrically connected to the second measurement electrode.

7. A concentration measuring apparatus for measuring concentration of a particular component in a sample liquid by utilizing an attachment mounted to the concentration measuring apparatus and provided with a test instrument;

the test instrument comprising a substrate, and a cover for defining a capillary together with the substrate;

wherein the test instrument comprises the capillary for moving a sample liquid, a liquid pooling portion communicating with the capillary for retaining the sample liquid to be introduced into the capillary, and a liquid introduction selector for selecting whether or not the sample liquid retained in the liquid pooling portion is introduced into the capillary;

wherein the concentration measuring apparatus further includes a selector for selecting whether or not the sample liquid is introduced into the capillary;

wherein the liquid introduction selector includes a discharge port for discharging air from an inside of the capillary, the discharge port being provided at the substrate and opened away from the cover; and

wherein the selector includes an air pump for sucking a skin of a patient in order to close the discharge port with the skin.