Chemistry: electrical and wave energy – Apparatus – Electrolytic
Reexamination Certificate
2000-01-21
2003-07-29
Warden, Sr., Robert J. (Department: 1744)
Chemistry: electrical and wave energy
Apparatus
Electrolytic
C204S401000, C204S406000, C422S082010
Reexamination Certificate
active
06599406
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a concentration measuring apparatus for measuring a concentration of a specific component in a solution with the use of a socalled biosensor, a test strip to be used in the concentration measuring apparatus, a biosensor system using the concentration measuring apparatus and the test strip, and a method for forming a terminal on the test strip. The solution to be measured is specifically humor, e.g., blood, blood plasma, urine, saliva, etc. Blood is particularly often used.
BACKGROUND ART
Measuring apparatuses using a so-called biosensor are now in practical use for quantitatively detecting a specific component in humors of living bodies such as blood, urine or the like. In the measuring apparatus of the type, a compact and disposable test strip is fitted as the biosensor, and for instance, blood is dropped on the test strip, thereby to measure a concentration of glucose, lactic acid, cholesterol or the like in the blood.
The aforementioned method and a structure of the test strip for the concentration measurement are disclosed, for example, in the published specification of Japanese Patent Laid-Open Publication No. 4-357452. The test strip of this prior art is constructed as shown in FIG.
33
. Specifically, a conductive carbon paste or the like is screen printed on a sheet of a strip of an insulating base material
2
thereby to form terminals
3
,
4
adjacent to each other at one end part in a longitudinal direction of the base material
2
. The terminals
3
,
4
are extended in the longitudinal direction to form a measuring electrode
5
and a counter electrode
6
facing the measuring electrode
5
at the other end part of the base material
2
. An insulating layer is formed on the insulating base material except for portions on the terminals
3
,
4
, the measuring electrode
5
, and the counter electrode
6
. A reaction reagent (not shown) composed of an enzyme, a mediator, etc. corresponding to a component to be measured is applied on the measuring electrode
5
and the counter electrode
6
. A cover
8
is fitted via a spacer
7
over the base material
2
except the terminals
3
,
4
. A test strip
1
of
FIG. 34
is thus obtained. A projection
10
is formed so as to prevent the test strip
1
from being set to a measuring apparatus in a wrong direction.
As is revealed, e.g., in the prior art No. 4-357452, the test strip
1
is set to a measuring apparatus
20
by being inserted from the side of the terminals
3
,
4
to a setting part
21
of a card-shaped measuring apparatus
20
as shown in
FIG. 35. A
display part
22
is provided at a surface of the measuring apparatus
20
to display measurement results. The setting part
21
of the conventional measuring apparatus
20
has a positive and a negative electrodes to be electrically connected to the terminals
3
,
4
of the test strip
1
when the test strip
1
is set to the measuring apparatus
20
.
After the test strip
1
is set to the measuring apparatus
20
, as is clear from the same prior art No. 4-357452, for instance, blood is spotted on the other end part of the test strip
1
, which is aspirated by a capillary action to a space
9
formed in the spacer
7
, reaches the reaction agent applied on the measuring electrode
5
and counter electrode
6
and reacts with the reaction reagent. A voltage is impressed then to the terminals
3
,
4
of the test strip
1
from the measuring apparatus
20
, whereby a reaction product through a reaction with the enzyme is oxidized. A current generated in this oxidation is measured at the measuring apparatus
20
. The measured oxidation current is converted to a concentration of the specific component to be measured.
The reaction reagent used is, e.g., one that includes glucose oxidase as the enzyme when glucose in the solution is to be measured, or that includes lactate oxidase, cholesterol oxidase when lactic acid, cholesterol in the solution is to be measured, as disclosed in a published specification of Japanese Patent Laid-Open No. 8-278276.
As is apparent from the above description, the test strip corresponding to each component to be measured can be obtained by replacing the enzyme contained in the reaction reagent without changing a basic of the test strip
1
. In other words, the structure of test strips can be made common in various kinds of components to be measured, and the measuring apparatus and manufacturing facility for the test strips can be shared, with the effect of a cost reduction for manufacturing the measuring apparatus and test strips. Although it is ideal that the test strips for corresponding components are demanded the same degree, practically, test strips for glucose are required most, while those for lactic acid or cholesterol are less required. If the test strips are constituted in the same structure, in the aforementioned irregular demand, the test strip for the irregular demand can be obtained simply only by changing the reaction reagent.
However, if in the common structure of test strips, it becomes difficult to distinguish the test strips, for example, between glucose test strips and lactic acid test strips. It may happen that the lactic acid test strip is inadvertently set to the measuring apparatus even though a concentration of glucose is necessary. Thus, an incorrect result is obtained.
The present invention is devised to solve the above-described inconvenience and has for its object to provide a concentration measuring apparatus, a test strip for use in the measuring apparatus, a biosensor system, and a method for forming terminals on the test strip whereby a target component is measured with the test strip fit thereto.
DISCLOSURE OF INVENTION
In accomplishing these and other aspects, according to a first aspect of the present invention, there is provided a concentration measuring apparatus to which a test strip is set, the test strip including on a base material a reaction reagent which is to react with a liquid test sample, a positive terminal, and a negative terminal, the terminals electrically detecting a concentration of a specific component in the liquid test sample based on the reaction of the reaction reagent, the concentration measuring apparatus comprising a positive electrode and a negative electrode to be electrically connected respectively to the positive terminal and the negative terminal of the test strip, thereby operating the concentration of the specific component in the liquid test sample via the positive electrode and the negative electrode, the concentration measuring apparatus further comprising a type judgement electrode for judging a type of the test strip set to the concentration measuring apparatus with the type judgement electrode provided separately from the positive electrode and negative electrode.
As is fully described above, in the concentration measuring apparatus of the first aspect of the present invention, the type judgement electrode is added separately to the positive electrode and negative electrode. Thus, the specific component to be measured can be measured by the test strip which is appropriate to measure the specific component with the utilization of the type judgement electrode.
According to a second aspect of the present invention, the concentration measuring apparatus may further comprises a first identification device for feeding information corresponding to the test strip for the liquid test sample capable of measuring the specific component based on a fact that the type judgement electrode is connected with the positive electrode only when the test strip capable of measuring the specific component is set to the concentration measuring apparatus, and a second identification device for identifying the test strip based on the information fed from the first identification device.
According to the concentration measuring apparatus of the second aspect of the present invention, the first and second identification devices are provided further in the measuring apparatus of the first embodiment, which exhibits the following effects. When
Ishida Kohei
Kawanaka Shoji
Tokuno Yoshinobu
Birch & Stewart Kolasch & Birch, LLP
Kyoto Dai-ichi Kagaku Co. Ltd.
Olsen Kaj K.
Warden, Sr. Robert J.
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