CA2137672A1 - Cuvette for automated testing machine - Google Patents

Abstract

2137672 9325889 PCTABScor01 A consumable, non-reuseable cuvette (10) for containing a sample or specimen during an automated test thereof, primarily for medical diagnostic purposes. The cuvette has a single, main reaction chamber that is pre-loaded at the factory with the precise quantity of a particular liquid or dry reagent useful for a specific test. The cover (20) of the cuvette includes an opening (26a) to permit the introduction of a diluent or liquid reagent into the reagent chamber, a manually loaded, recessed sample receiving chamber having a frangible bottom floor (36) and a purge reservoir. A
cap (28) is hinged to the cuvette cover and includes a rigid protruding member (34) that pierces the sample or specimen chamber floor when closed by the testing machine, sealing the contents of the cuvette, allowing the sample to be dispensed into the chamber containing the reagent and diluent. The side walls (18) and floor (16) of the reaction chamber include optically transparent windows for radiant energy testing of the reagent before and after the sample is added to the reagent. Because the cap seals the contents of the cuvette, the cuvette is safely disposable after the test is completed.

Description

~, W093,'25889 t PCr/US92/04882 2 CIJv~TTE FO~ Al~To~aTED TESTING MaC~IINE

3 This application is a continuation-in-part 4 application of U.S. Patent Application Serial Number 07/425,346, filed October 13, 1989, which is a continuation 6 application of No. 07/253,383, filed October 3, 1988, a 7 continuation application No. 07/042,795, filed April 27, 8 1987.
9 BACRGROIJND OF q~E INVENrION
l. Field of the Invention ll This invention relates to a disposable cuvette for 12 holding a test sample or specimen, reagent, and diluent 13 while performing a test in an automated machine, primarily 14 for medical diagnostic purposes. The disposable cuv~tte can 15 be prepackaged with a ~ry re~ - ent to which a di: ~nt is 16 added during a test c - wit, a liquid reagent ~nereby 17 eliminating the need for the addition of a diluent in an 18 automated test machine.
19 `~
20 2. Description of the Prior Art 21 Cuvettes utilized for manual or automated medical 22 testing are well known. In general, a procedure is 23 established to measure the emergent wavelength of radiant 24 energy absorbed by a sample under analysis. In a manual 25 test, typically a technician loads a cuvette with a sample, 26 reagent and diluent necessary to accomplish the test, each 27 ingredient being precisely measured. The contents are mixed 28 and the emergent radiation is observed optically or 29 ocularly. Because the kind and precise quantity of reagent 30 and diluent employed are critical to a successful test 31 result, technician time and expertise to prepare and use 32 cuvettes are significant factors to be considered with 33 regard to cost, human error, and emergency diagnosis.
34 Preparation time has also become a significant factor with 35 the introduction of automated medical diagnostic machines.
36 Such machines and their corresponding cuvettes have 37 attempted to reduce preparation time by prepackaging various 38 reagents and/or diluents in a container that itself W093/~89 21 3 7~ 72 PCT/US92/~U~2 ~.

2 ultimately houses a test performed therein. U.S. Patent 3 3,504,376 issued March 30, 1970 to Bednar et al. shows such 4 a system.
A significant factor in the use of automated test 6 equipment is that the reagent and the diluent mufit be mixed 7 prior to the addition of the sample so that the emergent 8 radiation from the reagent-diluent mixture can provide a 9 baseline measurement that is compared to the emergent radiation from the mixture that includes the sample. This 11 factor precludes mixing the sample at the same time the 12 diluent is added to the reagent. In the present invention, 13 the sample or specimen is manually loaded in a separate 14 chamber in the cuvette where it remains until after the reagent and diluent have been mixed and the baseline 16 measurement of the reagent-diluent taken. The use of 17 automated diagnostic test equipment still requires that all 18 ingredients necessary for a specific test be precisely 19 measured regardless of whether the cuvette is preloaded at the factory or loaded at the test site.
21 The use of multiple, separated compartments in 22 testing vessels with automated machines is shown in U S.
23 Patent 3,504,376 issued to Bednar et al on March 31, 1970 24 (cited above); U.5. Patent 4,458,020 issued to Bohn et al.
on July 3, 1984: and U.S. Patent 4,473,530 issued to Villa-26 Real on September 25, 1984. Each vessel shown is a complex 27 in physical structure and requires complex interaction with 28 the test equipment for operation.
29 Disposal of test containers having the residual samples and reagents therein poses a significant 31 environmental waste problem. Washing and reusing a cuvette 32 is not a good practice because the test results could be 33 affected by a poorly washed cuvette. With the present 34 invention, the cuvette remains sealed after the test and is not reusable.
36 As the use of prepackaged cuvettes increases in 37 volume, reducing the cost of the manufacture and factory 38 loading of the cuvette also becomes important.

f , W093J~889 PCT/US92/~#~2 `'' 3 2 8~MMARY OF T~E INVENTION
3 A disposable cuvette for performing a 4 predetermined medical diagnostic test of a specimen or sample in an automated machine comprising a hollow body 6 shaped to form a container (having an open top) for use as a 7 single reagent chamber. A cover is sealably attached over 8 the open top of said body, said cover having both an 9 aperture for introducing a diluent into the container body and a specimen receiving chamber with a frangible floor.
11 Attached to the cover is a hinged cap that includes a post, 12 sized and positioned to pierce the floor of the specimen 13 chamber whenever the cap is closed over the cover. A
14 precisely measured quantity of a reagent is loaded into the container at the factory. `
16 The specimen receiving chamber is integrally 17 formed within the cover and includes a frangible bottom 18 floor that can be broken open by action of the cap post. The 19 top of the specimen chamber may be covered by a thin hot-stamped film having a central annular opening for receiving 21 the end of a pipette for introduction of the specimen into 22 the specimen chamber.
23 The diluent dispensing aperture in the cover may 24 include depressible flaps closely adjacent to each other but separated by an "X" shaped space. The flaps act as a closure 26 for the body reaction chamber, but are easily opened by a 27 diluent dispensing device.
28 The cover is joined and sonic welded or otherwise 29 bonded about the upper rim of the container body itself.
The cuvette is used for testing a sample or 31 specimen as follows. Initially when the cuvette is 32 manufactured and prepared for market, a reagent of 33 predetermined kind and precisely measured qu,antity for a 34 particular test is placed in the container cody. The cover is welded to the container body, but the cap, hinged to the 36 cover, is not closed. A bar coded label identifying the 37 particular diagnostic test to be performed in the cuvette is 38 affixed to the outside wall of the cuvette body. The cuvette W093/~ ~9 + ; ~ PCT/US92/~U~2 ~
21 3 7i6 7~ 4 2 is then shipped with the cap in the open p~sition to the 3 site where the test is to be performed. A removable 4 adhesive-backed film may be used to cover the top surface of the cover to prevent contamination prior to use.
6 once at the test site, after the adhesive-backed ,7 film is removed from the cover surface, the cuvette is 8 readied for the automated test by the introduction of the 9 specimen into the specimen receiving chamber in the cuvette cover. This loading is done manually by a technician 11 inserting the end tip of a pipette containing the specimen 12 into the annular opening in the top of the specimen 13 receiving chamber in the cuvette cover.
14 The cuvette (now loaded with reagent and sample in a separate chamber) is placed into a circular cuvette holder 16 (carousel) within the automated test machine. The cuvette 17 while in place in the carousel is moved through a series of 18 operations in the machine as follows:
19 1. The carousel moves the cuvette to the bar code reading station. This identifies the test to be performed.
22 2. Diluent addition is performed at the second " " . .
G~ station. An automated dispensing arm pivots into position 24 into the diluent receiving aperture of the cuvette. As diluent fills the reaction chamber, air is vented throu~h 26 the .005 inch diameter holes until diluent reaches the holes 27 and the resulting surface tensions stops the fluid flow.
28 3. A vibrating action is now started to 29 thoroughly mix the diluent and dry reagent to produce a working unit dose reagent.
31 4. The machine then measures the emergent 32 radiation from the working reagent to obtain a baseline 33 measurement, i.e. reagent absorptivity only.
34 5. The machine then moves the cuvette cap to a closed position over the cuvette cover forcing the post to 36 break through the specimen chamber floor causing the patient 37 sample (urine, serum, plasma) to flow into the chamber 38 containing the reagent and diluent. The cuvet~e at this 2137~72 ~- W093/25889 PCT/US92/~82 2 point is entirely sealed by the cap.
3 6. A vibrating action is now started to mix the 4 specimen and reagent.
7. There is an incubation followed by a short 6 vibration, then the radiant energy absorption test is 7 performed. The difference in absorptivity of the test minus 8 the baseline reading permits calculation of a result based 9 upon a standard value for that test lot which is supplied by the bar code label to the instrument.
11 8. The cuvette can now be remo~ed from the 12 machine and safely discarded because the reacted specimen 13 cannot escape from the cuvette once the cap is c~osed. This 14 feature reduces or limits the release of chemicals and reacted patient samples in the hands of medical office 16 personnel. The cuvette is not reusable.
17 In an alternate embodiment the invention may be 18 used wherein a liquid reagent is introduced into the cuvette 19 at the factory. With this embodiment and the replacement of the dry reagent, the addition of a liquid diluent during the 21 machine test is eliminated. In order to prevent leakage of 22 the liquid reagent, an additional gasket/plug is provided on 23 the top cover. This is essentially a planar sheet of a 24 liquid impervious material and includes on one side a plug sized to fit firmly into the aperture in the cover that was ~6 previously used for the diluent addition. Also the cover has 27 been modified to eliminate the vents that were required when 28 adding liquid diluent which is used with the dry reagent.
29 It is an object of this invention to provide an improved cuvette that reduces the time required to prepare a 31 cuvette for a specimen or sample test in an automated 32 machine.
33 It is another object of the invention to provide a 34 cuvette that reduces the potential for human error by including a premeasured reagent and a reagent-diluent 36 chamber of a predetermined volume when filled for a 37 particular diagnostic, m dical test that requires a precise 38 reagent/specimen/diluent quantity ratio.

2137~72' .
W~93/2~9 PCT/US92/~W~2 ~, 2 And yet another object of this invention is to 3 provide a disposable, non-reusable cuvette that can be used 4 to safely dispose of the specimen and the reagent after the test is completed.
6 Another object of the invention is to provide a 7 cuvette that is non-complex in manufacture, that is readily 8 pre-loaded with a reagent at the factory, that is easily 9 manipulated by a technician during loading of the diluent and sample, and that is suitable for use in automated 11 diagnostic testing machines.
12 But yet still another object of this invention is 13 to provide a disposable cuvette that can be used with a 14 preloaded liquid reagent at the factory, that does not require the addition of a diluent during the test in an 16 automatic diagnostic testing machine.
17 In accordance with these and other objects which 18 will be apparent hereinafter, the present invention will be 19 described with particular reference to the accompanying drawings - 22 Figure l is a perspective view of the present 23 invention with the cap in the open position.
24 Figure 2 is a side elevational view of the invention in cross section, with the cap in the open 26 position.
27 Figure 3 is a side elevational view of the present 28 invention, in cross section, with the cap in the closed 29 position.
Figure 4 is a top plan view of the invention with 31 the cap in the open position.
32 Figure 5 is a side elevational view of the 33 invention with the cap in the closed position.
34 Figure 6 is an end elevational view of the invention looking at the end farther from the cap hinge.
36 Figure 7 is an enlarged side elevational view of 37 the invention, in cross section, with the cap in the open 38 position-~ .

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~137~72 ,~ W093/25889 PCT!US92/~U~2 2 Figure 8 is a top perspective view of an alternate 3 embodiment of the invention that includes (as shown 4 exploded) a gasket plug panel that is affixed to the top of the cover.
6 Figure 9 shows a bottom perspective view of the 7 alternate embodiment of the invention~
8 Figure 10 shows yet another embodiment of the 9 invention that is used with a prepackaged dry reagent only.
Figure 11 shows a side elevational cross sectional 11 view of the alternate embodiment construction of the cuvette 12 body and the specimen receiving chamber.
13 Figure 12 shows a bottom perspective view of the 14 cover used in the alternate embodiment of the invention.
PREFER~ED EMBODIMENT OF T~IE INVENTION
16 Referring now to the drawings, and in particular 17 Figure 1, the invention is shown generally at 10 comprised 18 of transparent body 12 and a cover 20.
19 The cuvette body 12 is a vassel or hollow container that includes end walls 14 connected to side walls 21 18 and bottom wall 16 forming a hollow rectangular box with 22 an open top. The body 12 may be molded as one piece from a 23 clear acrylic material, which is impervious to moisture or 24 atmosphere. The body material is selected to be sufficiently transparent to permit radiant energy absorption testing of a 26 specimen or sample contained within the body which serves as 27 a reaction chamber as will be further discussed. By way of 28 example but not limitation, the dimensions of the cuvette 29 body 12, stated in inches, may be .545 in length, .312 in width, and .545 in height. Of course the dimensions may vary 31 widely without departin~ from the scope of the invention. It 32 is important that the volume of the reaction chamber be such 33 that the reaction chamber when filled acts to provide the 34 exact volume for diluent added to the cuvette for a predetermined test.
36 The cuvette 10 also includes a cover 20 that is 37 sonic welded or otherwise bonded to ~ody 12. The cover 20 3~ provides several elements that are important for the .
`
W093/2~8~ 2 i 3 7 S 7 2 PCT/US92/~82 ~
-2 different operational testing stages in the automated 3 machine.
4 As shown in Figures 2, 3, and 4, these elements include the sample or specimen receiving chamber formed by 6 the cover barrier wall 22 having a vertical passage 22a 7 sealed at its lower end by a frangible, thin floor 36 and 8 partially covered at its upper end by a thin film 24 having 9 a circular opening near its center for receiving the end of a pipette. The cover passage 22a in conjunction with the 11 bottom floor 36 form the receiving cham~er for serum or 12 sample that is introduced by pipette through the opening in 13 thin film 24.
14 Another important element of cover 20 is a second vertical passage 26a that is partially covered by flaps 26 16 at its upper end. The flaps 26 are flexible and may be 17 opened downwardly by a pipette or other conduit shaped 18 injector to permit the introduction of a diluent into the 19 reaction chamber formed by body 12.
The cover 20 also has four .005 inch diameter vent 21 holes 44 that are very important in the operation of the 22 cuvette. The vent hole diameter is sized appropriately so 23 that air is vented to the outside as the diluent flows into 24 the reaction chamber. When the chamber is full, the surface 2S tension created by the .005 inch diameter holes prevents any 26 overflow of diluent through the vent holes 44.

27 The cover 20 includes a cap 28 attached by hinges 28 30. Protruding from one side of cap 28 and substantially 29 perpendicular thereto is a lancet-like post 34 having a "cross" shaped cross section relative to its longitudinal 31 axis. The post 34 is sized in length and positioned relative 32 to hinges 30 such that when cap 28 is closed over cover 20, 33 post 34 will be moved into passage 22a (serum receiving 34 chamber) piercing an opening in floor 36. The floor 36 is 3S connected to the chamber side walls 22a such that it cannot 36 be detached by the action of post 34. (If detached, floor 36 37 might interfere with light passage through the cu~ette.) 38 Also attached to cap 28 is a latch 32.

2137S7~
- W0 93/25889 ~ ; ; PCr/US92~04882 2 After the serum or sample has been manually added 3 to the receiving chamber 22a, the cuvette is now ready to be 4 loaded into an automated testing machine. Note that the cap 5 28 is in the open position when the cuvette is placed in the 6 test machine. Once in the machine, the cuvette bar code 7 label is read and the test parameters are automatically set.

8 Next the diluent is automatically dispensed into the cuvette 9 and a vibrating mixing action takes place. After the reagent 10 and diluent are fully mixed, a baseline radiant energy 11 absorption reading is taken. After this initial measurement, 12 an interposer with roller bearing mechanism (not shown) in 13 the machine closes the cap 28, and the cuvette, now sealed, 14 is vibrated. As the cap 28 is closed, the post 34 breaks 15 through the sample chamber floor 36, allowing the sample to 16 be mixed with the reagent-diluent mixture, aided by the 17 vibration. With the cap in the closed position, the cuvette 18 is completely sealed such that its contents cannot escape.

19 The cap 28 is fastened by the engagement of latch 32 with a 20 flange on bar 40. The machine can now complete the test on 21 ~he sample.

22 The cover 20 may be made from high impact styrene 23 and sonic welded to the upper rim of body 12. Hinges 30 and 24 cap 28 may be formed with the cover 20, with hinges 30 being 25 "living" hinges.

26 Figures 5 and 6 show the cuvette 10 after the cap 27 28 is closed. The cuvette, in accordance with the invention 2~ described herein, is designed for use in an automated 29 testing machine. The cap 28 includes parallel ridges 28a 30 that project above the upper surface of cap 28 to act as cap 31 stiffeners and a bearing contact surface for mechanically 32 closing the cap.

33 Figure 7 shows the cover 20 and the serum or 34 sample receiving chamber 22a and molded bottom floor 36 with a ~hinner flash section 36a tformed in an "X" shape) to 36 provide break lines when the post 34 applies pressure as the 37 cap 28 is closed.
38 The top of the serum chamber 22a is partially W093/~889 213 7 5 7 2 PCT!USg2~82 ~

2 covered by hot stamped film 24. Film 24 has a small opening 3 burned in the center to act as access for the end tip of a 4 pipette containing serum or sample and also to wipe the pipette tip dry as it is removed from the chamber 22a.
6 The top surface~ of the diluent access area (flaps 7 26 and adjacent area) are made parallel to the underside 8 surface of the cap 28 that abuts the diluent access 9 perimeter in order to provide a parallel seat for the machine actuated, diluent dispenser tip and achieve a good ll seal when the cap 28 is closed.
12 Figures l and 7 show vent holes 44 that aid in the 13 filling of the reagent chamber with diluent by allowing air 14 that would otherwise be trapped in the reaction c:hamber to escape. Note that the diameter of each vent hole is sized so 16 that diluent will not escape through the vent holes because 17 of the surface tension of the diluent over the vent opening.
18 However, the vent holes are sealed from the ambient air when 19 the cap is closed. After the test has been completed, the 2Q cuvette can be safely discarded because the contents are 21 sealed from the ambient surroundings.
22 The cuvette and the specific test to be performed 23 therein (dependent upon the kind and quantity of reagent it 24 contains) is identified by labels 46 adhesively attached to each side 38 of the cover. One label on one side would have 26 a machine readable bar code while the other side label would 27 display a letter or number code that is easily identified by 28 the test operator.

29 Referring now to Figure 8 an alternate embodiment of the invention is shown which is used with a liquid 31 reagent. The liquid reagent is prepackaged in the cuvette at 32 the factory. By using a liquid reagent, it is not necessary 33 to provide the liquid diluent reguired with a dry reagent in 34 the automated test device when performing a test. Therefore, in general, the cuvette 110 is modified (1) by eliminating 36 the vent holes which are required when using a dry reagent 3~ that requires diluent and (2) by adding an additional 38 sealing panel 144 which will be described in greater detail 2137~7~ ' f~ W093/~8~9 PCT/US92J~82 2 below. The cuvette 110 is comprised of a hollow body 112 3 (providing a rectangular parallelepiped interior chamber) 4 that includes side walls 118 uniformly molded as a single unit with end walls 114 and a bottom wall 116 (Figure g) 6 forming a hollow receptacle for receiving a liquid reagent, 7 prepackaged at the factory. The side walls 118 include an optically clear window 118a on opposite side walls 118 to 9 permit the optical or ocular testing for the liquid reagent alone and when subsequently mixed with the specimen. One 11 locating key 156 is centered on each side to locate the 12 cuvette with respect to the automated testing machine.
13 The cover 120 is ultrasonically or otherwise 14 bonded to the body 112 and includes a circular aperture 126 and a flat top wall 1~2 that includes a specimen chamber 16 formed by side walls 122a and bottom trap doors 136 which 17 are sealed together initially but are frangibly openable by 18 action of post 134 when the cap 128 is closed in the 19 automated test machine. A purge reservoir 124 for purging the diluent dispenser tip in the automated equipment is 21 provided to wash out residual reagent and prevent carry over 22 into the next or following cuvette which may contain a 23 different reagent. The cover 120 includes a pair of arched 24 side members 138 which function and interact with tne automated machine as a roll down surface.
26 A sealing panel 144 is e~ployed solely with a 27 cuvette using a liquid reagent, elim_nating the need for a 28 diluent. The upper surface of top wall 122 also includes 29 grooves 154 longitudinally disposed along each edge which receive glands 152 in the gasket./plug sealing panel 144 to 31 firmly seal panel 144 over the cover surface 122. The panel 32 144 also includes an aperture 1~0 which permits access to 33 the specimen chamber defined by walls 122a so that the 34 specimen can be added to the specimen chamber.
The cap 128 includes a modified post 134 having 36 inclined surfaces 134b terminating in knife-like edge end 37 tip 134a which acts as a pl`unger for piercing the specimen 38 chamber trap doors 136 at the centerline of the doors to W093/25889 PCT/US9~ 2 ensure proper separation to effect direct hinge action of 3 the doors 136 to~release the specimen into the cuvette body 4 112 containing the liquid reagent.
Referring now to Figure 9 the cuvette 110 is shown 6 from a bottom perspective view disclosing the bottom wall 7 116 having an optically clear window 116a which permits fluorescent polarization and nephlometric type tests.
~ The cap 128 is unitarily connected by a hinge 130 which also acts to seal the end of the cuvette when the cap 11 128 is closed oYer the cover 120.
12 The cap 128 includes a pair of parallel ridges 160 13 which interact with the automated machine and rollers for 14 closing the cap 128 and resulting in a secure latching of the cap.
16 A pair of snaps 132 which are integrally formed 17 with the cap 128 are engaged into slot edges 140a at the 18 opposite end of cover 120 to firmly attach the cap to the 19 cover when the cap is closed resulting in a leak-proof seal.
Referring back to Figure 8, in the manufacture of 21 the liguid reagent model, the plug/gasket sealing panel 144 22 is firmly attached at the factory to the top of cu~ette 23 cover 120 after the liquid reagent has been inserted into 24 the cuvette body 112 chamber. With the panel 144 attached, the liquid reagent is sealed tightly within the cuvette by 26 action of the panel 144 which includes plug 148 received 27 into aperture 126 and the fact that the specimen trap doors 28 136 in the specimen chamber 122a are also sealed.
29 To perform a test using the liquid reagent model, the specimen is added to the specimen chamber 122a at the 31 testing site, which may be a doctor's office, laboratory or 32 the like. The cuvette 110 then is inserted into the 3 automatic testing machine in the cuvette's cap open position 34 as shown in Figure 8. The automated machine can first test the liquid reagent alone in its present state (before the 36 specimen is mixed) while the cuvette 110 is located at a 37 test station in the automatic testing machine. After a first 38 measurement of the liquid reagent is obtained, optically or 213~672 f` WO9~/25889 PCT/US92/~82 2 ocularly, then the testing machine closes the cap 128, 3 causing the post 134 to fracture and open the two inclined 4 trap doors 136 causing the specimen to be received into the interior chamber of cuvette body 112 containing the liquid 6 reagent. The cuvette is then boosted for mixing, causing a 7 rocking action on its radius corners adjacent the bottom 8 floor 116, greatly i.ncreasing the mix action. A second 9 measurement is then obtained optically or ocularly of the liquid reagent-specimen mixture and the results calculated 11 by the testing machine.
12 A raised sealing bead 142a (Figure 8) is disposed 13 about the surface of cap surface 142. The bead is a raised 14 portion such that when cap 128 is closed firmly against ~5 panel 144 (made of a silicone rubber), the bead 142a will be 16 impressed into the silicone rubber of panel 144, forming a 17 tight liquid impervious and air impervious seal about the 18 cover top surface 122 including the purge chamber 124.
19 Referring now to Figure 10, a modified cuvette llOa for use with a prepackaged dry reagent ~pow~ered or 21 capsule) is shown which is inserted in the cuvette ~_~y 112.
22 Note that in this embodiment the plug/gasket panel 144 23 (Figure 8) is not used. The aperture 126 acts to receive ~
24 diluent dispensing probe in the automated machine (not shown) for dispensing diluent into the cuvette body 112 that 26 houses the dry reagent. The diluent is added at the test 27 site while performing the test in the automated machine. The 28 purge reservoir 124 collects diluent purged from the diluent 29 dispensing tip (not shown) after the dispensing tip has been withdrawn from aperture 126 during the testing process. In 31 this alternate embodiment three vent slots 162, 164 and 166 32 are provided which collectively allow for air to escape from 3 the cuvette body 112 while the diluent is being~added.

34 A thin frangible film 168 of hydrophobic metricel polypropylene is used to cover the vent holes 162, 164 and 166 and diluent aperture 126, specimen chamber 122a and the purge reservoir 124. The film 168 is gas permeable which 38 allows air to vent through the vent slots during diluent W093/25889 2 1 3 7 6 7 2 PCT/US92/o~2 ~i 1 ~4 2 dispensing while also allowing easy fracture for insertion 3 of the specimen into the spPcimen chamber 122a. The film 168 4 provides another benefit in that the sealing beads 142a in cap 128 will also engage the thin film when the cap 128 is 6 closed and locked over cover 120 again ensuring that the 7 cuvette is sealed after the test is completed. The film is 8 atta¢hed to the cover surface by a suitable glue.
9 In this embodiment the cuvette llOa functions similarly to the original cuvette 10 discussed in Figures 1 11 through 7 with regard to the powdered and capsule reagents 12 in term of operation and the automated machine.
13 Figures 9 and 11 show another improvement in the 14 alternate embodiment of the invention that functions with a carousel in the automated test machine which carries each 16 cuvette through the automated test machine. As shown in 17 Figures 9 and 11, the side end wall 114 includes, on each 18 end, a lateral, concave channel 114a which acts to receive 19 snap legs which are in the automated test machine (not shown) to firmly hold the cuvette in position relative to 21 the carousel and the machine. Also the lower corners 114b 22 formed by the side walls 114 and the bottom wall 116 have 23 equal predetermined radii of curvatures. At a particular 24 stage in the automated test machine, the curved corners ~14b engage surfaces having comparable curvatures on the snap 26 legs to produce a rocking motion whenever the carousel is 27 moved backward and forward to induce vigorous mixing within 28 the cuvette after the specimen has been introduced to the 29 reaction chamber and the cap is closed. Thus the curved end portions 114b while engaging a similar surface of curvature 31 on the snap legs will permit a rocking motion back and forth 3~ for improved mixing action. The bottom wall surface 116 is 33 substantially flat to permit a roller or wheel in the 34 automated test machine to raise the cuvette, disengaging the snap legs from the snap leg detent 114a at the mixing stage 36 in the machine. Thus the cuvette is configured on its 37 outside and bottom walls to allow the snap legs in the 38 automated testing machine to accomplish the dual purposes of 2137~72 f /~s889 ~ PCI/US92/04882 2 allowing for rocking the cuvette for mixing while in the 3 other stages to secure the cuvette in position in the carousel.
5Figures 11 and 12 show the specimen receiving 6chamber defined by wal,s 122a and bottom trap doors 136 7 which are sealed toge~her along a frangible center line 136a 8 forming the bottom of the specimen chamber 122a.
9The bottom trap doors ~36 are inclined to reduce 10possible trapping of bubbles when diluent or liquid reagent 11are dispensed through aperture 126. In their initial state 12the hinged doors 136 are joined together and to the walls 13122a of the specimen cham~er so that the compartment is 14sealed from the body 112 chamber. The post 134 size and 15shape is configured to more 17easily fracture and open the trap doors 136 in the specimen 18chamber when the cap 128 is closed tightly over the cover of 19the cuvette. In the cross section as shown, the linear 20weakened portions 136a and 136b between the walls 122a and 21the doors 136 form an "H" shape. The trap doors 136 remain 22 sealed until forced open by the post 134 which causes the 23centerline 136a and the wall edges 136b to frangibly detach 24 forcing the doors to open much like a pair of trap doors.
25 Note that the bottom floor is inclined relative to the 2~ horizontal which aids in dispensing the specimen into the 27 reagent containing chamber 112. Note also from Figures 8 and 2810 that the post 134 end tip includes a pair of inclined 29surfaces 134b terminating in the edge 134a which meets the 30centerline 136a of the trap doors 136 when the cap is closed 31 aiding the doors 136 to spread open from the center 32 positi~n. This allows the specimen to be completely received 33 into the mixing chamber 112a where it mixes with either the 34 dry reagent and diluent mixture o- with a liquid reagent.
35Figures 11 and 12 also show hinge 130 that 36connects the cap 128 (partially shown) unitarily to the -37cover 120.
38The present invention provides a disposable, non-r. ~ ~

W093/~889 2 1 3 7 ~ 7 2 16 PCT/US92/~U~2 ~

2 reuseablè cuvette that allows a technician in a doctor's office or laboratory to perform a variety of medical 4 diagnostic tests quickly, safely, accurately and inexpensively by significantly reducing the technician 6 loading activities required and the structural complexity of the cuvette and its interaction with the testing machine.
The instant invention has been shown and described 9 herein in what it is considered to be the most practical and preferred embodiment. It is recognized, however, that departures may be made therefrom within the scope of the invention and that obvious modifications will occur to a 13 person skilled in the art.

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Claims (21)

What I claim is:

1. A disposable cuvette for performing a diagnostic test on a sample in an automated machine capable of measuring the radiant energy absorbed by a sample under analysis comprising:
a hollow body forming a container with an open top;
a cover sealably attached over the open top of said body, said cover including a sample receiving chamber having a bottom floor, and said cover having a first aperture for the introduction of a diluent into said container body; and a cap sized to fit over said cover to seal said first aperture and said cap including means for piercing the bottom floor of said sample receiving chamber when said cap is attached to said cover, sealing the cuvette.

2. The cuvette as in claim 1, wherein:
the body container volume is predetermined to contain when full the required amount of diluent for a predetermined test to be performed in said cuvette.

3. The cuvette as in claim 1, including:
a reagent disposed in said container body of predetermined kind and quantity for performing a particular test on a sample.

4. A cuvette as in claim 1, wherein:
said sample receiving chamber bottom floor is a thin film that can readily be pierced by said means to pierce said sample chamber.

5. A cuvette as in claim 1, wherein:
said sample receiving chamber bottom floor is a moveable closure that is activated to open when said cap is placed in a closed position relative to said cuvette.

6. A cuvette as in claim 1, wherein:
said sample receiving chamber in said cover includes a thin film cover having an aperture therein for admitting the end of a pipette.

7. A cuvette as in claim 1, including:
moveable flaps mounted over the cover first aperture for admission of a diluent dispenser.

8. A cuvette as in claim 1, wherein:
said cap is integrally formed with said cover and said cap hinges.

9. A cuvette as in claim 1, wherein:
said cover includes a pair of parallel, upwardly disposed ridges for mechanical interface of said cuvette within an automated testing machine.

10. A cuvette as in claim 1, wherein:
said cover having vent holes to aid in full diluent dispensing and sized in diameter to prevent diluent passage thereinto because of the surface tension of the diluent.

11. A cuvette as in claim 1, wherein:
said sample receiving chamber bottom floor is a thin membrane having a breakline of minimum thickness formed in the injection molding process that is pierced when said cap is placed in a closed position relative to said cuvette cover.

12. The method of performing automated, medical diagnostic testing on a sample in a cuvette comprising the steps of:
a) providing a cuvette with a reaction chamber;
b) pre-loading said cuvette reaction chamber with a particular reagent for performing a particular diagnostic test;
c) loading the sample at the test site into a frangible receptacle in said cuvette above said reaction chamber;
d) loading said cuvette into an automated testing machine;
e) filling the reaction chamber with diluent;
f) mixing the reagent and diluent in the reaction chamber;
g) measuring the emergent radiation of the reagent-diluent mixture to obtain a baseline absorptivity measurement;
h) sealing said reaction chamber while simultaneously rupturing said sample container receptacle causing said sample to be admitted to said reaction chamber;
i) mixing said reagent, diluent and said sample; and j) measuring the emergent radiation of the contents of the reaction chamber.

13. A cuvette for performing an automatic diagnostic test on a specimen comprising:
a hollow body having a bottom wall and a plurality of side walls unitarily formed defining a rectangular reagent receiving chamber, at least two opposing side walls having windows sufficiently transparent to permit radiant energy transmission for optical or ocular testing;
a substantially rectangular cover having a flat central portion and raised side ridges, said cover sealed to the upper end of said hollow body side walls, said cover including a specimen chamber having side walls extending downwardly from a specimen chamber aperture in said cover, said specimen chamber including a pair of movable closures forming the bottom floor of said specimen chamber, said movable closures initially joined together along opposing edges and including a frangible joint therebetween, each removable closure hingedly connected to said opposite specimen chamber side walls, said cover including an aperture for receiving a liquid dispensing probe for dispensing a liquid into said reagent receiving chamber;
a sealing cap having an upper surface and a lower surface relative to a closed position for sealing said cover openings, said sealing cap hingeably connected to one end of said cover, said cap including an elongated post extending substantially perpendicularly from the lower surface of said cap and positioned and sized to engage and open the movable closures forming the bottom wall in said specimen chamber whenever said cap is in a closed position over said cover.

14. A cuvette as in claim 13, wherein:
said specimen chamber floor including said movable closures is inclined angularly relative to the bottom wall of said hollow body to reduce the possible trapping of bubbles when diluent or liquid reagent are being dispensed into said reagent chamber.

15. A cuvette as in claim 13, including:
a raised bead disposed in predetermined areas around the periphery of the cap lower surface to aid in sealing the cap to said cover when said cover is in a closed position.

16. A cuvette as in claim 13, wherein:
said cap post is configured to include an elongated shaft body and a shaft tip, said shaft body having a cross-shaped cross section and said shaft tip having a pair of flat surfaces angularly inclined relative to each other to form a knife-like edge substantially aligned with the centerline between said movable closures of said specimen chamber when said cap is closed.

17. A cuvette as in claim 13, wherein:
a purge reservoir formed in said cover near one end of said cover, said purge reservoir including a plurality of walls and a floor formed within the cover structure.

18. A cuvette for use with a liquid reagent as in claim 17, including:
a sealing gasket sized to fit over a predetermined portion of said upper cover surface, said sealing gasket including a plug that is received into said diluent receiving aperture, and a specimen chamber aperture to permit access to said specimen chamber.

19. A cuvette for use with a dry reagent as in claim 17, including:
air venting means provided through said cover surface layer to vent said reagent chamber; and thin gas permeable film affixed to said flat central cover portion, overlaying said dispensing probe aperture, said specimen chamber aperture and said venting means.

20. A cuvette as in claim 17, wherein:
said hollow body bottom wall includes a window sufficiently transparent to permit transmission of radiant energy for fluorescent polarization and nephlometric testing.

21. A cuvette as in claim 17, wherein:
said hollow body side walls and bottom wall having exterior surfaces including detents strategically located for engagement with snap legs in said automated test machine and forming edges of a predetermined radius of curvature to permit vigorous rocking motion of said cuvette in said automated test machine.