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MODULAR ANALYZER SYSTEM

This is a continuation of co-pending application Ser. No. 06/884,464 filed on July 11, 1986 now abandoned. 5

Background

The present invention relates generally to the field of clinical chemistry and more particularly to clinical chemistry analyzers suitable for use in hospitals, and 10 commercial laboratories.

A number of clinical chemistry analyzers are available in the art. Such analyzers vary from simple, essentially manually operated instruments to complex, highly automated analyzers. IS

Each analyzer has its own particular performance characteristics related to the number or menu of different tests that the analyzer can perform, the number of samples that may be placed onto the analyzer, and the number of samples that can be processed in a given 20 period of time, or "throughput." Often, analyzers that provide rapid sample analysis offer a relatively limited menu of tests. Conversely, other analyzers, sometimes referred to as random access analyzers, may offer a much larger menu of tests but have a correspondingly 25 decreased sample throughput.

The high volume, limited menu analyzers described above frequently offer a menu directed to those tests or chemistries that are most commonly performed for patient samples, such as sodium, potassium, glucose, 30 creatinine, BUN, and the like. In comparison, the large menu, lower throughput analyzers may well offer such high demand chemistries but also offer chemistries that are required on a relatively infrequent basis.

A clinical chemistry laboratory may, for example, 35 require a high throughput, limited menu analyzer, preferring to use the services of commercial laboratories for low demand tests, or performing low demand tests using complementary general purpose instruments. The requirements of the laboratory, however, may change 40 with time. An initial need to perform only limited menu, high volume tests on an automated analyzer may well expand to additionally require automated analysis of low-demand tests where the costs or inconvenience of commercial laboratories become great or where the 45 volume of low-demand tests overwhelms the capabilities of general purpose instruments.

One solution to this problem is to simply install a second separate automated analyzer to satisfy the new demand. However, an additional analyzer requires addi- 50 tional operating personnel, separate sample preparation and loading, separate test selection and programming, and the collation of separate test results for samples drawn from the same patient. All of these drawbacks lead to increased laboratory operating expenses, a par- 55 ticular disadvantage in light of today's ever-increasing awareness of health care cost containment.

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When combined to form a broad-capability analyzer, such analyzer utilizes a single sample loading system and need only be programmed to select the tests for a particular sample, regardless of which module performs the tests. Accordingly, analyzer operation is simplified and streamlined, decreasing costs and saving floor space within the clinical laboratory facility.

A system in accordance with the present invention includes at least a first and second analyzer each including sample carousels, analyzing means, and automated probe means for transferring samples from the sample carousels to the analyzing means. Each of the analyzers also includes indexing and joining means for precisely joining the first and second analyzers and indexing the first analyzer automated probe with respect to the second analyzer sample carousel. Control means in one of the first or second analyzers synchronizes and controls the first analyzer automated probe means, the second analyzer automated probe means and the second analyzer sample carousel so that the automated probe means for both the first and second analyzers can access samples received in and carried by the second analyzer sample carousel. Preferably, the sample carousel in the first analyzer is removed and sample volumes for the first analyzer are obtained from the sample carousel of the second analyzer.

Brief Description of the Drawings

FIG. 1 is an isometric view of a first modular analyzer in accordance with the system of the present invention.

FIG. 2 is an isometric view of a second modular clinical analyzer in accordance with the system of the present invention.

FIG. 3 is a clinical analyzer formed using the modules of FIGS. 1 and 2.

FIGS. 3A and 3B are side views of means for joining modules as shown in FIG. 3.

FIG. 4 is a functional block diagram of electronic interface signals provided between modular analyzers forming the system of FIG. 3.

FIG. 5 is a simplified wash fluid diagram for the analyzer of FIG. 3.

Detailed Description

With reference to FIG. 1, a modular analyzer 10 in accordance with the present invention is a limited-menu high-throughput analyzer. The modular analyzer 10 includes a sample carousel 12 which includes a plurality of sample receiving wells 14 disposed in circular concentric rows near the periphery of the carousel 12. The carousel 12 may be removed from the modular analyzer 10 for loading of samples into the wells 14 in a conventional fashion. The sample carousel 12 includes means for rotation such as, for example, a stepper motor so as to position the wells 14 for removal of sample therefrom.

A sample arm 16 is supported at one end by a displacement mechanism 18 for raising and lowering the arm 16 and rotating the arm 16 about the mechanism 18 in a conventional fashion. The sample arm 16 supports a probe 20 which describes an arc 22 over the working surface of the modular analyzer 10. More particularly, the arc 22 passes over sample pickup stations above the inner and outer rows of the sample receiving wells 14 so that samples from wells in either of the rows may be withdrawn into the probe 20. The arc 22 also passes over four analysis modules 24, 26, 28, 30 of a conven

3 4

tional design. Each of the modules 24, 26, 28, 30 in- adapted to extend the probe travel arc 22 beyond the

eludes a sample receiving port and is adapted to receive side 59 to a position that is outside of the frame 42.

sample volumes from the probe 20 and perform analyses With reference now to FIG. 2, a large menu, random

thereon. The modules 24, 26, 28, 30 may be similar to, access clinical modular analyzer 60 is shown therein,

for example, various of the modules included in the 5 The modular analyzer 60 includes a frame 62 supporting

ASTRA ® Analyzer from Beckman Instruments, Inc. a working surface 64. The working surface 64 includes

of Brea, California. a sample carousel 66 adapted to receive a plurality of

The arc 22 also swings over a sample injection cell 32 sample sectors 68, each of the sectors 68 including ten

adapted to receive sample volumes from the probe 20 openings 70 therein each for receiving a sample cup 72.

and flow such volumes to a flow analysis module 34 10 The sample carousel 66 is automatically rotated by

capable of analyzing "electrolytes" including chloride, means of, for example, a stepper motor as is well known

sodium, potassium, and C02. The flow analysis module m the aIi

34 may be similar to the flow analysis techniques used in The sample sectors 68 are loaded onto the modular

theE4ATM Analyzer from Beckman Instruments, Inc., analyzer 60 at a loading tray 74. The loading tray 74

of Brea, California. The sample injection cell 32 in- 15 includes a transfer mechanism 76 which transfers one

eludes means for sealing the probe 20 therein while sample sector 68 from the loading tray 74 to a transfer

sample volumes are injected from the probe 20 into the Position 78 and simultaneously transfers a sample sector

cejj 32 68 at the transfer position to the loading tray 74. In the

The modular analyzer 10 also includes locations embodiment disclosed herein, the transfer mechanism about the arc 22 for wells 38 and 40 adapted to receive 20 76 °Pera^s by lifting the sample sectors 68 on the loadcalibration reagents which may be required for calibra- m8 tray 74 ^ at the transfer position 78 up and above tion of various of the modules 24, 26, 28, 30, 34. the samPle sfctors <» °« the sample carousel 66. The

The working surface of the modular analyzer 10 is mechanism 76 then steps one sector position

supported by means of a frame 42. The frame 42 also „ clockTMse f seen fTMmab°ve >n FIG. 2, lowering the

supports an electronics card cage 44 which includes a 25 *amPle sectors ba<* ^ °adm§ tray J4 a«d °nt°

I T* c u J A* _■• i J- At J the sample carousel 68 at the transfer position 78.

plurality of circuit boards 46, a disk drive 47, and re- ~ r .. , v _^

f. , / . . . .. , . , , The working surface 64 also supports a reaction

lated electronic circuitry for controlling the modular . , on ?. . i r i

i mn-j • „ j. . ^ r. wheel 80 which m turn carries a plurality of sample

analyzer 10. Fluid reservoirs 48 contain reagents for use «. «m u * •* • t. m. *• u i on

^ J i ,„ ,„ ,,. . * • , cuvettes 82 about its periphery. The reaction wheel 80

in the modules 24, 26 28, 30 34 A conventional com- 3Q ^ IQmed fe means 0£s£ motor that is controlled

puter terminal including a keyboard and CRT, and a m nse tQ tfae m electronics and control cir.

printer (not shown) are connected to the electronic cuit A flash photometer w at the periphery of the

circuitry included in the card cage 44 for providing reaction whed „„ cooperates with the wheel 80 to di

operating instructions to, as well as receiving results rect u ht thr h the cuvettes 82 M the reaction wheel

from, the modular analyzer 10, all m a conventional 35 80 is rotated In the embodiment disclosed herein, the

fashion. reaction wheel 80 may support eighty cuvettes 82 and

The modular analyzer 10 as described above is thus a be controlled so as to intermittently rotate at approxi

high-throughput, limited-menu analyzer of the type mately ninety RPM during which time the flash pho.

known in the art which is adapted to perform parallel tometer 34 operates to obtain polychromatic colorimet

analyses concurrently in the modules 24, 26, 28, 30, 34 w ric data for the fluids carried within the cuvettes 82. A

for a sample volume drawn from the sample carousel CUVette wash station 85 also at the periphery of the

12. The operating cycle of the modular analyzer 10 reaction wheel 80 washes the cuvettes 82 to clean and

generally mcludes drawmg a sample volume from the prepare the cuvettes 82 for another analysis,

sample carousel 12 into the probe 20, rotating the arm A refrigerated storage compartment 86 contains a

16 to the sample injection cell 32 and injecting a portion 45 plurality of reagent cartridges 88 supported by a rea

of the sample volume into the cell 32 for analysis by the gent carousel 90. Each of the cartridges 88 includes

flow analyzer module 34. The arm 16 raises the probe three separate compartments adapted to hold reagents

20 and rotates the probe 20 along the arc 22 to deposit for a particular test or chemistry performed by the

portions of the sample volume to the analyzer modules modular analyzer 60. The reagent cartridges 88 may be

24, 26, 28, 30 for individual analysis therein. The probe 50 placed onto and removed from the reagent carousel 90

32 is then moved to the cell 32 for washing the probe tip via a front door 92 in the compartment 86. The com

and to complete the analysis and calibration cycle for partment 86 includes a rotational mechanism 93 for

the flow analysis module 34, preparing the modular rotating the reagent carousel 90 so as to position one of

analyzer for the next operation cycle. the reagent cartridges 88 under three openings 94, 96,

The modular analyzer 10 is adapted in accordance 55 98 formed in the top of the compartment 86. The open

with the present invention to operate as a portion of a ings 94, 96, 98 allow access to the reagent cartridges 88

system of modular analyzers. More particularly, the for removal of reagent therefrom,

frame 42 includes a plurality of holes 50, index plates 52, The working surface 64 also supports a sample trans

54, and holes 56, 58 in such plates 52, 54. Each of the fer and stirring mechanism 100 and a reagent transfer

index plates 52, 54 is precisely located with respect to 60 and stirring mechanism 102. Preferably, the sample

the displacement mechanism 18 and the arc 22 de- transfer and stirring mechanism 100 includes a fluid

scribed by the probe 20. The holes 50 are placed in the probe assembly 104 pivoted about a pivot point 106. A

frame 42 proximate a side 59 of the modular analyzer 10 probe 108 is carried by the assembly 104. The assembly

nearest the displacement mechanism 18. The portion of 104 is adapted to withdraw a predetermined sample

the frame 42 through which the holes 50 pass defines a 65 volume from a sample sector 68, raise the probe 108

plane that is a predetermined distance from the displace- above the sample sector 68, pivot the probe 108 to a

ment mechanism 18. Further in accordance with the sample injection position above a predetermined cu

present invention, the displacement mechanism 18 is vette 82 on the reaction wheel 80, lower the probe 108

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to the cuvette 82, and dispense the predetermined sample volume therein.

The mechanism 100 also includes a stirring assembly HO supporting a motorized stirring rod 112 that may be swung into position over the cuvette into which sample 5 has been injected. The stirring assembly 110 lowers the stirring rod 112 into the cuvette and the rod is rotated to stir the contents of the cuvette

Similarly, the reagent transfer and stirring mechanism 102 includes a reagent fluid probe assembly and a stir- 10 ring assembly similar to those just described. The reagent fluid probe assembly is adapted to swing the reagent probe in an arc over the openings 94,96, 98, lower the probe through the appropriate opening into a reagent cartridge 88, withdraw reagent into the probe, 15 elevate and move the probe over a cuvette on the reaction wheel positioned at a reagent injection station, lower the probe into the cuvette 82 and inject reagent into the cuvette 82.

Both the sample and reagent transfer and stirring 20 mechanisms 100 and 102 also pass over wash stations for washing the respective probes and stirring rods. The mechanisms 100 and 102, as well as the associated wash stations, are controlled automatically in fashions that are well known in the automated clinical analyzer art. 25

The modular analyzer 60 also includes a card cage 114 which holds a disk drive 115 and a plurality of circuit boards containing the control and analysis electronics for the modular analyzer 60. A conventional computer terminal including a keyboard and CRT, as 30 well as a printer (not shown), are connected to the control and analysis electronics for providing test and operating instructions to the modular analyzer 60. Such instructions may include, for example, patient name, patient ID number, sample sector ID numbers, and the 35 tests that are to be performed for samples carried by the identified sample sectors. The terminal and printer also receive and display the results of tests performed by the modular analyzer 60.

Although a particular embodiment of an modular 40 analyzer 60 has been described above, it is to be recognized that the modular analyzer 60 is merely an example of a large-menu, reduced throughput clinical analyzer of a type well known in the art. In the embodiment disclosed herein, the modular analyzer 60 performs 45 repeated operating cycles each including sample and reagent addition to cuvettes and rotations of the reaction wheel 80 to thus provide serial analyses of samples on the reaction wheel 80. Briefly, the modular analyzer 60 is controlled to deposit reagents into a cuvette 82. 50 With repeated operating cycles, the reaction wheel 80 advances the cuvette 82 around the reaction wheel 80 until a sample is added to the cuvette 82 and the analysis is performed using the photometer 84 to obtain data as described above. Additional operating cycles advance 55 the cuvette through the wash station 85, preparing it for a subsequent analysis. The analysis data is processed by the control and analyzers electronics to provide test results via the terminal and/or printer.

In accordance with the present invention, the frame 60 62 includes four holes 118 (only two of which are shown) formed therethrough. Two index plates 120 (only one of which is shown) are fixed to the frame 62 proximate the front and rear vertical members thereof. Each of the index plates 120, 122 includes holes 124, 65 formed therethrough precisely located with respect to the central axis and horizontal operating plane of the sample carousel 66. The portion of the frame 62 though

6

which the holes 118 pass defines a plane that is a predetermined distance from the central vertical axis of the sample carousel 66. The position of the holes 118 and 124 are a mirror image of the holes 50 and 56, 58 in the modular analyzer 10. Furthermore, the card cage 114 is adapted to include an interface card functioning as described hereinbelow.

The individual modular analyzers 10 and 60 may be operated independently to perform clinical chemistry tests, addressing certain distinct capacity, menu and throughput capabilities needed in clinical chemistry laboratories. Advantageously, the analyzers 10 and 60 may be uniquely joined to form a single clinical chemistry system 127 (FIG. 3) possessing the attributes of both of the analyzers 10 and 60 while significantly decreasing operator workload and involvement as compared to two separate analyzers.

More particularly, side panels 128 and 130 on the right side of the modular analyzer 10 as viewed in FIG. 1. may be removed from the modular analyzer 10. Side panels 132 and 134 on the left side of the modular analyzer 60 as is seen in FIG. 2. similarly removed from the modular analyzer 60. As seen with reference to FIG. 3, the modular analyzers 10 and 60 are positioned side-byside. Spacers 136 are placed between the holes 50 and 118 in the modular analyzers 10 and 60 (FIG. 3A) and are retained by bolts 138 and nuts 140. Locating pins

142 are inserted into the holes 56, 58, and 124 within the corresponding index plates 52,54, and 120. A false panel

143 is installed between the modular analyzers 10 and 60 to maintain separate cooling air flow within the repective modular analyzers 10 and 60

The spacers 136 provide a precise parallel spacing relationship between the planes defined by the frames 42 and 62 through which the holes 50 and 118 are formed. The locating pins 142 provide precise vertical and horizontal alignment of the frames 42 and 62.

The predetermined relationship between the frame 42 and the index plates 52 and 54 with respect to the displacement mechanism 18 and probe 20 as well as the predetermined relationship between the frame 62, plates 120, 122 and the sample carousel 66 allow the sample arm 16 to swing the probe 20 along the ar 22 from the modular analyzer 10 into the modular analyzer 60 to selected sample aspiration or pickup locations above the sample carousel 66. Thus the probe 20 can access samples carried by the sample carousel 66. With all samples for the modular analyzer 10 coming from the sample carousel 66, the sample carousel 12 is removed from the modular analyzer 10.

Electronic, electrical and fluid interfaces are also provided between the analyzers 10 and 60 to form the system 127. Interface circuit cards 144 and 146 are installed into the card cages 44 and 114 and suitable cabling 147 is connected therebetween. The disk drive 47 in the analyzer is removed. The interface cards provide suitable electronic interfaces between the electronics installed in the card cages 44 and 114. Specifically, interface card 146 provides program, data and timing signals via the cabling 147 to the card 144. As seen with reference to the block diagram of FIG. 4, the program and data signals include operational information and instructions entered into the modular analyzer 60 through the disk drive 115 or the terminal connected thereto. For example, such operational information and instructions include the identification and location of samples on the sample carousel 66 that require analysis by the modular analyzer 10. The data signals also iden

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