Method for quantitating a substrate and measurement device used therefor

• US 6,051,392 A
• Filed: 06/09/1999
• Issued: 04/18/2000
• Est. Priority Date: 06/10/1998
• Status: Expired due to Term

• Current Assignee: PHC Holdings Corporation
• Original Assignee: Matsushita Electric Industrial Company Limited (Panasonic Holdings Corporation)
• Inventors: Ikeda, Shin, Yoshioka, Toshihiko, Nankai, Shiro, Watanabe, Motokazu
• Primary Examiner(s): Leary, Louise N.
• Application Number:
  US09/328,510
• Time in Patent Office: 314 Days
• Field of Search: 435/25, 435/283.1, 435/14, 435/817
• US Class Current: 435/25
• 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 5/150435 Specific design of proximal end
• 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15171 Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: Y10S 435/817 Enzyme or microbe electrode

Abstract

The present invention provides a measurement device facilitating accurate quantitation of a substrate from a trace amount of sample and a highly reliable quantitating method of a substrate. The method uses an analysis element comprising a pair of electrodes for electrochemically quantitating reaction between a substrate in a sample and an oxidoreductase. One of the electrodes of the analysis element is a membrane formed on an inner wall of a cylindrical hollow space having an opening and the other is a needle. The needle electrode is projected temporarily external to the hollow space to puncture a subject and the resultant sample is collected from the subject.

Claims

1. A method for quantitating a substrate comprising the steps of:

preparing an analysis element comprising a needle electrode, a membrane electrode and a cylinder having a hollow space, said hollow space being open at least one end thereof, wherein said needle electrode is accommodated in said hollow space and said membrane electrode is formed on an inner wall of said hollow space;

pressing an opening of said cylinder against a subject to be examined;

projecting a tip of said needle electrode external to said opening of said cylinder temporarily to puncture said subject and collecting a sample from said subject;

introducing the collected sample between said membrane electrode and said needle electrode in said cylinder;

reacting a substrate contained in said sample with an oxidoreductase; and

applying a voltage across said membrane electrode and said needle electrode and measuring resultant current in said membrane electrode or said needle electrode.

2. A measurement device for electrochemically quantitating a concentration of a substrate contained in a sample based on reaction between said substrate and an oxidoreductase, said device comprising:

an element having a cylindrical hollow space, said space being open at least one end thereof;

a membrane electrode formed on an inner wall of said hollow space;

a needle electrode accommodated in said hollow space; and

means for projecting a tip of said needle electrode external to said hollow space temporarily.

3. The measurement device in accordance with claim 2, wherein said needle member is formed with an electrically insulating layer on a portion of the surface thereof.

4. The measurement device in accordance with claim 2, wherein said needle member is formed with a reagent layer containing an electron acceptor and an oxi-doreductase on the surface thereof.

5. The measurement device in accordance with claim 2, wherein said hollow space is further formed with a reagent layer containing an electron acceptor and an oxidoreductase on an inner wall thereof.

6. The measurement device in accordance with claim 2 further comprising a unit for fixing the needle electrode at the predetermined position after the projection of said needle electrode.