Method of judging presence of frameless chemical analysis...

Chemistry: analytical and immunological testing – Automated chemical analysis – With sample on test slide

Reexamination Certificate

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C422S063000, C436S050000

Reexamination Certificate

active

06468801

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a method of judging presence of a frameless chemical analysis film in a cartridge, and more particularly to a method of judging whether there remains a frameless chemical analysis film in a cartridge in which a plurality of chemical analysis films are stored in a stack. The frameless chemical analysis film (including biochemical anlysis films and immunological anlysis films) is a film chip carrying thereon a reagent layer containing a reagent whose optical density changes through a chemical reaction, a biochemical reaction, an immunoreaction (immunological or immunochemical reaction) or the like with a specific biochemical component contained in a sample liquid such as blood or urine.
2. Description of the Prior Art
Quantitative or qualitative analysis of a specific component in a sample liquid is a common operation carried out various industrial, medical and clinical fields. Especially, quantitative analysis of a chemical or biochemical component or a solid component contained in body fluid such as blood or urine is very important in the field of clinical biochemistry.
There has been put into practice a “dry-to-the-touch” chemical or biochemical analysis film with which a specific component contained in a sample liquid can be quantitatively analyzed through a droplet of the sample liquid spotted on the slide. See Japanese Patent Publication No. 53(1978)-21677, (U.S. Pat. No. 3,992,158), Japanese Unexamined Patent Publication No. 55(1980)-164356, (U.S. Pat. No. 4,292,272) or the like. When such a dry chemical analysis film is used, the sample liquid can be analyzed more easily and more quickly than when the conventional wet analysis method is used, and accordingly the dry chemical analysis film is very convenient for medical facilities, laboratories and the like where lots of sample liquids have to be analyzed.
In a biochemical analysis apparatus for quantitatively analyzing chemical components or the like contained in a sample liquid using such a dry chemical analysis film, a droplet of the sample liquid is spotted on the film and is held at a constant temperature for a predetermined time (incubation) in an incubator so that coloring reaction adequately occurs, and the optical density of the color formed by the coloring reaction is optically measured. That is, measuring light containing a wavelength which is pre-selected according to the combination of the component to be analyzed and the reagent contained in the reagent layer of the film is projected onto the film and the optical density of the film is measured. Then the component to be analyzed is calculated on the basis of the optical density using a standard curve which represents the relation between the concentration of the biochemical component and the optical density. Thereafter the film is taken out from the incubator and discarded into a discarding box.
The chemical analysis film is generally composed of a support sheet of an organic polymer or the like and a reagent layer and a spreading layer formed on the support sheet and is conventionally generally provided with a plastic frame which holds the chemical analysis film flat which is apt to warp into a roof tile shape when it keeps in dried conditions. The chemical analysis film with frame is generally referred to as “chemical analysis slide”. However, the frame increases the volume and the size of the chemical analysis film and results in increase in the size of various parts handling the film such as cells in the incubator for incubating the chemical analysis films, the film transfer system, the film supplier for storing the films, the film cartridges and the like. Thus the frame of the chemical analysis film is obstructive to reducing the size of the biochemical analysis apparatus and at the same time reduces the film accommodating capacity of the incubator, which obstructs increase in handling capability of the overall biochemical analysis apparatus. Further the cost of mounting the frame is high, which adds to the cost of biochemical analysis.
In a biochemical analysis apparatus we have proposed previously, the film chip is used as it is without frame (will be referred to as “frameless chemical analysis film”, hereinbelow). For example, in the biochemical analysis apparatus disclosed in Japanese Unexamined Patent Publication No. 5(1993)-188058 (corresponding to EP 0 555 654A2) or Japanese Unexamined Patent Publication No. 6(1994)-213903 (corresponding to EP 0 567 067A), a plurality of the frameless chemical analysis films are loaded in a cartridge and are taken out from the cartridge by means of an attracting means such as a reduced pressure suction cup in order to prevent damage to the film.
In such a biochemical analysis apparatus, a plurality of cartridges in which different types of frameless chemical analysis films (films for different analytes: biochemical components to be analyzed) are stored are set in the apparatus. When an analyte is designated, one of the cartridges in which frameless chemical analysis films corresponding to the analyte are stored is set to a film takeout position, the attracting means is moved to the film takeout position and then suction force (reduced pressure) is applied to the attracting means to attract one of the frameless chemical analysis films in the cartridge which is nearest to the film takeout position. Thereafter the attracting means is moved in a predetermined direction while holding the frameless chemical analysis film under the suction force to take out the film through a film takeout port in the cartridge. These operations are automatically carried out according to a predetermined program stored in the biochemical analysis apparatus.
When there remains no film in the cartridge set to the film takeout position, the series of the operations for taking out the film becomes vain, which deteriorates analyzing efficiency of the apparatus. Accordingly it is preferred that whether there remains some films in the cartridge be detected in advance and when no film remains in the cartridge, the operations for taking out the film from the cartridge be abandoned and the operations for taking out the film from another cartridge be effected immediately while alarming the operator absence of film (that there remains no film in the cartridge) by means of a buzzer, a lamp, a display or the like.
As disclosed in U.S. Pat. No. 4,190,420, there has been known a system in which whether there remains some chemical analysis slides in a cartridge is judged by means of a limit switch. That is, as shown in
FIGS. 16A and 16B
, a plurality of chemical analysis slides
250
(though only one slide is shown in
FIG. 16A
) are stacked in a cartridge
210
and a pressing member
232
is received in the cartridge
210
to be movable up and down in the cartridge
210
. When a slide
250
is to be taken out, the pressing member
232
is pushed upward by a plunger
228
and presses the stack of the slides against the inner surface of a support portion
252
which projects downward from the top wall of the cartridge, thereby bringing the uppermost slide to a slide exit port (not shown) formed in a side wall of the cartridge
210
. (
FIG. 16A
) In this state, the uppermost slide
250
is pushed transversely by a blade
222
through the slide exit port whose width is slightly larger than the thickness of the slide
250
.
The width of the blade
222
is smaller than that of the slide
250
and the space between abutment edges
234
and
236
of the pressing member
232
is smaller than the width of the slide
250
and larger than the width of the blade
222
and the width of the support portion
252
. Accordingly when the last slide
250
is pushed out of the cartridge
210
, the abutment edges
234
and
236
of the pressing member
232
are moved upward beyond the lower surface of the support portion
252
into the spaces
254
and
256
between the support portion
252
and the side wall of the cartridge to abut against the bottoms of the spaces
254
and
256
as shown in

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