JPH0375826B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a reagent container used in a testing device.

In clinical laboratory equipment, raw or diluted samples are often mixed with one or more reagents, and the resulting reactions are tested to determine specific components of the sample to be tested. For example, in a clinical chemistry test device, a small sample of serum is mixed with various amounts of different reagents to create a chemical reaction that allows specific components of the sample of plasma to be measured.

Centrifugal clinical testing devices are useful for performing a variety of tests, including dynamic endpoint tests, using absorption, light scattering, and/or fluorescence techniques. Typically, such analyzers use a multi-cube rotor with a centrifugal array of spaced apart elongated radially extending cuvettes, each containing a sample of blood or other biological fluid. an inner chamber for initially accommodating a first reactant, and an outer chamber for initially accommodating one or more different reactants. The two chambers are separated by a dividing structure, and the reactants are centrifugally transferred to a testing area at the outer end of the cuvette for mixing, reaction, and subsequent testing. Typically a small sample (2-
20 microliters) is filled into the inner chamber,
A quantity of reactant up to about 200 microliters is charged to the outer chamber. In a typical test procedure, the rotor device is first rotated at 100 rpm, then accelerated to about 4000 rpm per second to transport the reactants from the inner chamber, and then accelerated to about 4000 rpm per second to transport the reactants from the inner chamber. The brakes are applied and then the test speed (typically 500-
1000rpm).

Such test devices are commonly used to test biological fluids such as blood, plasma or serum components, absorbance mode tests such as glucose, cholesterol, creatinine, total protein, calcium, phosphorus, enzymes, glucose, bile acids, etc. , phenytoin, pheophyllin, gentamicin, etc., are tested in fluorescence or light scattering mode. In order to perform a variety of tests, a large variety of reagents must be available since each different test uses one or more different reagents. storage into a test cuvette, such as the apparatus shown in Rosse, U.S. Pat. No. 3,718,439; dispensing from bulk storage, as in the apparatus shown in Mody, U.S. Pat. No. 4,323,537. A wide variety of techniques are used for handling reagents, including: Such devices have various limitations and complications.

To solve the above-mentioned conventional drawbacks, the present invention provides a sealed reagent container 10 having a body portion 12 having length and width dimensions each larger than a height dimension.
The main body portion 12 includes: upper walls 18, 22 and a bottom wall 20; and extends between the upper walls 18, 22 and the bottom wall 20 and converges to join at the pointed end 14. With each vertical side wall 26 located at the end of the container 10 opposite the tip 14, the vertical side wall 26 and the top and bottom walls 18,2
2 and 20; and a passage 30 provided in the neck 28 formed in the upper wall 22 of the main body 12 and standing upright from the upper wall 22, the end side wall said opening 30 being located in an asymmetrical position such as adjacent to section 16;
and a coupling structure 66 that interengages with a corresponding coupling means of the reagent container rotation table 132 to be firmly positioned thereon, the body portion 12 of the reagent container further comprising: 28
has a through hole 60 spaced a predetermined distance from the port 30 provided in the main body portion 12 , the through hole 60 has an open upper end and a lower end, and the through hole 60
The reagent container is characterized in that the reagent container extends between the upper wall portion 22 and the bottom wall portion 20 in a sealed manner.

Therefore, the above configuration of the present invention has the following advantages.

The reagent container has each vertical wall section 26 and an end side wall section 16.
Since it is formed into a substantially triangular shape when viewed from above, each pointed end 14 of the rotary table is
By arranging the reagent containers near the rotation center of the rotary table, a plurality of reagent containers can be closely arranged adjacent to each other in the circumferential direction of the rotary table,
This has the advantage that the installation space can be reduced.

In addition, when reagent containers are closely arranged on the above-mentioned rotary table, the sample (sample)
When two probes (pipettes) for use and reagent are simultaneously inserted into one sample container and one reagent container on the rotary table, respectively, and used to aspirate the sample and reagent simultaneously and separately. However, sometimes when only one of the two probes mentioned above is inserted into the reagent container and only the reagent is aspirated, the remaining probe may be inserted into the reagent container. It may interfere and become a nuisance.

However, according to the reagent container of the present invention, even in the latter case, if the through hole is positioned in advance so that the remaining probe is inserted into the through hole 60 of the reagent container, the above-mentioned problem can be achieved. Since the remaining probes do not interfere with the reagent container, it is possible to aspirate only the above reagent without any inconvenience. In other words, it is applied to a two-probe probe,
The two probes can be used to aspirate different types of liquids at the same time or to aspirate only one type of liquid, which has the advantage of widening the scope of application and making it more convenient.

Since not only the upper end but also the lower end of the through-hole 60 is open, the remaining probe has a stroke sufficient to move within the through-hole further downward than its lower end, so it cannot be inserted into the through-hole 30. The first probe moved down sufficiently to the bottom side wall of the reagent container can aspirate the reagent without leaking and can improve the aspirating efficiency.

Therefore, for example, the reservoir 5 is located below the passage 30.
2, the remaining probes can take a sufficient downward stroke with respect to the through-hole, so the first probe can sufficiently move downward to the pool and similarly perform sufficient suction.

In a preferred embodiment, the reagent container is capable of performing at least 100 tests and is of a one-time use (disposable) type; Some are made of stretch-molded (by suction-molded) polymeric materials that form designated reagent storage containers that are removed by a transfer structure.

Other features and advantages of the invention will become apparent from the following description of an exemplary embodiment in conjunction with the drawings.

DESCRIPTION OF THE PREFERRED EMBODIMENTS The reagent container 10 shown in Figures 1-4 has a body portion 12 with a capacity of 20 ml and has walls of a stretch-molded polymer material with a thickness of about 1 mm and a corner radius of about 3 mm. It is blow molded from high density polyethylene. The main body 12 has a tip portion 14 and an end side wall portion 1.
6, the width at the end wall 16 is about 3 cm, the front upper wall 18 and the flat bottom wall 20.
The height between the two is approximately 1.7cm. The rear upper wall 22 is approximately 3 mm below the front wall 18 and opens at an angle of approximately 18 degrees from the tip 14 at an angled transition 24 of the flat, generally vertical side wall 26 of the container 10 .
has. A protrusion 36 indicating a series of volumes is formed on the side wall 26.
and upper wall 18, having an annular recess 34 and sealed with a pierceable probe membrane 32 of Aclar (chlorotrifluoroethylene) or other suitable material. A cylindrical neck structure 28 defining a circular aperture 30 projects upwardly from the rear upper wall 22. Cooperative closed cap molded from Kraton 4
0 is an upper wall portion 44 having a cylindrical wall portion 42, a probe web portion 46 having a diameter of approximately 3 mm and a thickness of 0.3 mm and capable of being pierced in the center, and an arcuate portion 48 having an equivalent thickness.
and has.

Further details of container 10 can be understood with reference to Figures 2-4. A protrusion 50 forming a generally rectangular reservoir with a depth of about 1/4 cm, a width of about 2.2 cm, and a length of about 1.6 cm is aligned with the cylindrical neck 28. As shown in FIG.
Machine-readable barcode information 54 indicating the reagent material 56 stored in the container is provided. A through-hole type cylindrical sleeve 60 (0.6 cm in diameter) provided in front of the reservoir section 50 is connected to the opening 64 of the lower wall section 20.
and the passage 62 of the upper wall 22 and is sealed to the interior of the main body 12 . Between the opening 64 and the tip 14 is a cylindrical container placement protrusion 66 with a diameter of about 1/2 cm and a length of about 1/4 cm.

The chamber portion provided by the upper wall 18 in the higher position and partially delimited by the sloped transition wall 24 is used, for example, when the stored dry reagent material 56B is reconstituted with liquid. It provides an air pocket area of approximately 2 ml volume which effectively limits the filling of container 10 and also provides a void space for agitation and mixing of the reagent materials.

Further details of the closure cap 40 can be understood with reference to FIGS. 5 and 6. This cap is molded from Kraton and measures approximately 2 cm in diameter and 0.4 cm in height. The cylindrical wall 42 is approximately 0.5 mm thick and has a retaining rib 68 (approximately
(projecting 0.2 mm) engages in the recess 34. In this state, the cap 40 provides a removable closure cover for the container 10 which additionally protects the reagents and reduces evaporation.

The reagent 56 is in a liquid state (56 in FIG. 8) in the container 10.
A) or dry powder state (56
In the latter case, the container may be sealed in a bag 70 for additional protection during long-term storage. Container 10
will be placed in a storage carton 72 having a compartment formed by a septum 74 for receiving the reagent containers 10 as shown in FIG. A storage section 76 further provided within the carton 71 contains a bottle 78 for reconstitution liquid.
, and storage 80 receives a smaller vial 82 .

Container 10 is shown schematically in FIG. 9 and is adapted for use with a centrifugal testing device. The test system is equipped with a supply station having a group of test rotors 102 of the type shown in related U.S. patent application Ser. 104
It includes an inspection compartment 100 housed in a. Each rotor 102 has 39 test cubes. The test compartment 100 also includes a drive mechanism for positioning the rotor 102 to move the cuvette 106 past a filling position 110 where the cuvette chamber is filled with sample and reagent materials by a transfer mechanism 112. A filling table 108 including
an inspection station 114 including a drive mechanism for rapidly rotating the rotor 102 to mix and then transport the reactants from the individual cuvette chambers for inspection at a speed of approximately 600 rpm; and an optical module 116. , and a used rotor station 118 where the rotors are temporarily stored after inspection for reuse (if there is a cuvette not used for inspection) or deposited for disposal. A transfer mechanism 120 transports the rotor 102 from the supply station 104 to a filling table 108 where several cuvettes of the rotor are filled with sample and reagent materials, and then the filled rotor is driven into rotation for reagent-reagent mixing and testing. It includes an arm for gripping the contents of the rotor cuvette for transport to a test station 114 and then to a used rotor station 118 after the rotor's contents have been tested. Inspection area 10
Further details of the apparatus in 0 are hereby incorporated by reference in the concurrently filed ``Cubette Handling''.
As may be understood from related U.S. Patent Application No. 706,073 entitled .

The apparatus also includes a storage compartment 122 separated from the test compartment 100 by an insulating wall 124.
Sample cups 12 are arranged in a circular row within compartment 122 and past sample station 130.
8 and a transfer table 132 capable of accommodating twenty reagent containers 10 arranged in a circular row for movement of the reagent containers past the reagent station. The transfer mechanism 112 includes two pipette tubes 140, 142.
A pipette arm 138 with a A position in the storage compartment 122 where one pipette matches the sample cup 128 in the sample station 130 and a second pipette matches the opening 30 of the reagent container 10 in the reagent station 134 (or the pipette 14
0,142 to and from a dilution position in station 134 that coincides with the openings 30 and 62 of container 10. Further details of the transfer mechanism 112 may be found in related U.S. Patent Application No. 599,509, filed April 12, 1984, entitled "Liquid Handling," which is incorporated herein by reference. A test station 11 is located in a third compartment separated from the test compartment 100 by an insulating wall 152.
A radiation light source 154 is housed, which acts in conjunction with the optical module 116 for photometric testing of a sample of the rotor 102 at 4.

A more detailed illustration of the sample and reagent transfer mechanisms 126 and 132 may be understood with reference to Figures 10-12. Sample ring 126 has a set of 44 sockets 160 each receiving a sample cup 128 having a capacity of about 1/4 ml. The transfer ring 126 has a drive socket 162 that engages a drive projection 164 on a drive table 166 (FIGS. 11 and 12).
The table 166 also includes a cylindrical alignment ridge 168 and a stepper for indexing the sample ring 126 through the sample station 130.
A protruding boss 170 connected to a motor (not shown)
The actuation of ring 126 requires 40 steps to index ring 126 to one sample location. An aperture 172 in drive table 166 is alignable with an optical reader 174 mounted on the underside of table 166 as shown in FIG.

A drive shaft 176 having a drive connection 178 at the top end
passes through the boss 170 of the sample ring drive table 166. Reagent container transfer turntable 13
2 is received by the drive shaft 176. Turntable 132 includes a radially extending flat plate 182 approximately 21 cm in diameter and approximately 1/4 cm thick. The radially projecting fingers 184 around the periphery of the plate 182 form a series of twenty recesses, each approximately 2.2 cm wide and approximately 1.2 cm radially deep. Radially inward and adjacent to each recess is an opening 186 with a diameter of 0.6 cm and an opening 188 with a diameter of about 1/2 cm. an upper handle portion 192 approximately 2 cm in diameter; a middle flange 194 approximately 5 cm in diameter; a series of 20 alignment cylindrical recesses 19;
A boss 190 is centrally attached to the plate 182 and has a base portion 196 approximately 4 cm in diameter having a diameter 8 formed around it. A drive key 200 is formed in the socket of boss 190 that engages drive coupling 178 when turntable 132 is on table 166.

Each reagent container 10 has a pointed end 14 with a flange 194.
is frictionally held underneath and abuts within the alignment recess 198, with the alignment protrusion 66 within the inner alignment opening 188 and the rectangular reservoir 50 within the recess formed between adjacent fingers. Then, the reagent container 10 is placed on the table 132 such that it is reliably positioned on the table 132. In this state, the sleeve 60 passing through each passage matches the intermediate opening 186. The table 132 with the reagent containers 10 mounted thereon is then inserted onto the upright shaft 176 to engage and drive it, as shown in FIG. Tables 132, 16
6 is arranged in this way, the sample table 1
32 is aligned to align the aperture 172 with the optical reader 174, and then the table 1
32 are aligned by a stepper motor via shaft 176 (40 steps for each reagent position).
The barcode information 54 on the reagent container 10 is read and the confirmation information for the reagent is stored in the storage section of the control device of the testing device. 20 for the groove 178 of the drive shaft 176
The position of each reagent container 10 is set. Similarly, interengaging notches 162 and keys 164 set the angular position of each sample container 128 relative to drive boss 170.

During operation of the apparatus to transfer samples and reagents from the containers 10 and 128 to the cuvette 106 of the rotor 102 at the filling station 108, the transfer arm 138 positions the pipettes 140, 142 at the sample and reagent filling station by respective drives. the selected reagent containers and sample containers. As a result, one type of reagent and one type of sample are normally aspirated at the same time by the pipettes 140 and 142 that move up and down at the same time. Next, when using two types of reagents for one type of sample in a test, first the tip of the pipette 140 is aligned with the opening 30 of the reagent container, and the tip of the pipette 142 is aligned with the opening 62 of the through hole 60. Then, the transfer arm lowers and pipette 1
The tip of 40 is attached to the membrane 32 or the web 4 of the cap.
6 into the reagent in the container 10 of the reagent station, and the pipette 142 passes through the space in the through hole 60 without being immersed in the reagent, so that the measuring injection part injects a certain amount of reagent into the pipette 140. The transfer arm 138 transfers it so as to draw it in. Transfer arm 138 is then raised and moved to position pipette 140 at sample station 130, reagent table 132 is aligned to position second container 10 at reagent position 134, and the two pipettes are is simultaneously lowered into the sample cup 128 and another reagent container 10, and an amount of sample set by the control of the device and a second reagent different from the first reagent are withdrawn into the pipette. The transfer arm 138 is then raised and moved laterally to the filling station 110, and the pipette is lowered through the opening of the cuvette 106 at the filling station 110, dispensing pipette amounts of sample and reagent into respective chambers of the cuvette. Ru.

After some or all of the 39 cuvettes 106 of the rotor 102 have been filled (again determined by the machine control), a rotor transport mechanism 120 transports the filled rotor 102 from the filling station 110 to the inspection station 114. The rotor 102 rotates to centrifugally mix the sample and reagent, and the resulting mixture is tested. After the test is completed, the rotor is moved from test station 114 to temporary storage station 118 to remove the next rotor (previously removed from the supply stack for transfer to filling station 110 for filling as described above). ) moves to the inspection station 114.

Although specific embodiments of the invention have been illustrated and described, it will be obvious to those skilled in the art that various modifications may be made.
The invention is therefore not limited to the described embodiments or to the details thereof, but various modifications can be made without departing from the spirit of the invention.

[Brief explanation of drawings]

FIG. 1 is a perspective view of a reagent container according to the invention. FIG. 2 is a plan view of the reagent container shown in FIG. 1. FIG. 3 is a side view (partially cut away) of the reagent container. FIG. 4 is a bottom view of the reagent container. FIG. 5 is a top view of the container cap. FIG. 6 is a cross-sectional view of the cap of the container of FIG. 5 taken along line 6--6. Figure 7 shows straight line 7- in Figure 2.
FIG. 7 is a sectional view of a reagent container placed on top of FIG. FIG. 8 is a perspective view of a reagent container storage structure and a corresponding reagent container. FIG. 9 is a top view of a centrifugal testing device using a reagent container of the type shown in FIG. 1st
FIG. 0 is a top view showing details of a mechanism for handling reagent and sample containers used in the testing device shown in FIG. 9. Figure 11 is the straight line 11-11 in Figure 10.
It is a sectional view taken above. FIG. 12 shows a handling mechanism for reagent and sample containers.

Claims (1)

[Claims] 1. A sealed reagent container 1 having a body portion 12 having length and width dimensions each greater than a height dimension.
0, the body portion 12 extends between the upper walls 18, 22 and the bottom wall 20, and converges and joins at the pointed end 14. Each vertical side wall 26 is located at the end of the container 10 opposite the tip 14, and the vertical side wall 26 and the top and bottom walls 18, 2 are located opposite the tip 14, respectively.
2 and 20; and a passage 30 provided in the neck 28 formed in the upper wall 22 of the main body 12 and standing upright from the upper wall 22, the end side wall said opening 30 being located in an asymmetrical position such as adjacent to section 16;
and a coupling structure 66 that interengages with a corresponding coupling means of the reagent container rotation table 132 to be firmly positioned thereon, the body portion 12 of the reagent container further comprising: 28
has a through hole 60 spaced a predetermined distance from the port 30 provided in the main body portion 12 , the through hole 60 has an open upper end and a lower end, and the through hole 60
A reagent container, characterized in that the reagent container extends between the upper wall portion 22 and the bottom wall portion 20 in a sealed manner. 2. The connecting structure 60 of the reagent container 10 includes a protrusion 50 protruding from the bottom wall 20 and provided with a machine-readable code 54 relating to the reagent contents of the container. The reagent container according to item 1. 3. A port 30 in the neck 28 is sealed by a membrane 32 that is perforable by a probe 140 and further includes a removable closure cap structure 40 for releasably engaging the neck structure 28. Claim 1 or 2 characterized by
Reagent containers as described in section. 4. A series of volume indicators 36 along the body portion 12 between the tip 14 and the neck 28 for indicating the volume of reagent material within the body portion 12. A reagent container according to any one of items 1 to 3. 5. The body portion 12 of the container 10 has a reservoir 52 in the bottom side wall 20, the reservoir 52 forming the neck 2 forming the opening 30 to maximize the efficiency of transfer of reagents from the container.
The reagent container according to any one of claims 1 to 4, wherein the reagent container is arranged in alignment with the reagent container. 6. The reagent container 10 includes an air chamber structure formed in the upper wall of the container above the junction between the body portion 12 and the neck 28, and the volume of the air chamber is the same as that of the sealed reagent container 10.
6. A reagent container according to any one of claims 1 to 5, characterized in that it is at least 5 percent of the total volume of the reagent container.