Data processing: generic control systems or specific application – Generic control system – apparatus or process – Having operator control interface
Reexamination Certificate
2000-06-24
2002-08-27
Gordon, Paul P. (Department: 2121)
Data processing: generic control systems or specific application
Generic control system, apparatus or process
Having operator control interface
C345S960000
Reexamination Certificate
active
06442440
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to automated clinical analyzers having the ability to provide multiple assay versatility and flexibility, and more particularly, to a method for controlling the operation of the plurality of interrelated automated analytical and sample preparation devices and for obtaining information about the status of a given sample or device.
BACKGROUND OF THE INVENTION
Clinical diagnostic analyzers are being developed with increasing levels of complexity and sophistication in order to fully automated the performance of chemical assays and immunoassays of biological fluids such as urine, blood serum, plasma, cerebrospinal liquids and the like. Generally, reactions between an analyte in a patient sample and reagents used during the assay result in generating some sort of signal that can be measured by the analyzer. From this signal the concentration of a analyte in the patient sample may be calculated.
In addition to automation, there is increased emphasis on the capability of an analyzer to provide multiple assay versatility and flexibility and at the same time reducing demand on the skills of the operating technician to perform complex programming and scheduling of assays or other analyzer functions. At the same time, modern clinical analyzers must be more cost and performance effective in terms of operating costs, turnaround time of test results, maintenance, operator training, etc. Thus, during the operation of such an analyzer, it is often critical for a technician to be able to easily and quickly obtain particular information about the assay status of a given sample among a large number of sample also being assayed, the quality performance of an analyzer, and generally be able to access a vast amount of information helpful in providing clinical diagnosis to a patient.
U.S. Pat. No. 6,058,764 discloses an analytical apparatus which can produce an analytical value on the basis of data entered during manual sample preparation which can be easily traced and used editing of the analytical result of the analyzer. The analytical apparatus has an input device for inputting sample preparation procedures through a display screen, and various computations based on weighed quantities, and constant dilution volume are automatically entered during the manual preparation as to eliminate human error.
U.S. Pat. No. 5,885,530 describes a high throughput automated immunoassay system which can perform high volume testing on a broad range of analytes while selecting from among a diverse set of immunoassays for any given sample. The immunoanalyzer has the capacity to perform a wide range of different types of immunoassays by facile storage and automated combination aboard the or analyzer among a wide variety of different types of reagents and heterogenous immunoassay beads stored on-board the analyzer. The automated design allows reduced user interface (e.g., tests are performed automatically from computer input) including the ability to order, perform and reassay tests reflexively based on test results without operator intervention.
U.S. Pat. No. 5,482,861 is typical of modern analyzers and discloses a typical modern automated analyzer providing continuous and random access analysis, having apparatus and methodology capable of simultaneously performing multiple assays of liquid samples using different assay methodologies. A method is also disclosed of operating an automated continuous and random access analytical system capable of simultaneously effecting multiple assays of a plurality of liquid samples wherein scheduling of various assays of the plurality of liquid samples is followed by creating a unit do disposable and separately transferring a first liquid sample and reagents to a reaction vessel without initiation of an assay reaction sequence, followed by physical transfer of the unit dose disposable to a processing device, whereby a mixture of the unit dose disposable reagents and sample are achieved during incubation.
U.S. Pat. No. 5,437,838 discloses a multi-tasking clinical laboratory work-flow system for test sample an reagent transfer to semi-automate various laboratory assays. The system includes a controller having a menu of protocols which provide format instructions to a robotic sample transfer device. The sample transfer device includes a work-flow surface having defined coordinates for mounting one or more test racks and one or more reaction mediums, and means for interacting a test sample with one or more reagent(s) or gel in a reaction medium.
U.S. Pat. No. 5,316,726 discloses an automated immunoassay analyzer includes a computer controlled instrument and display. The display provides a real-time presentation of all operations being performed within the instrument. A large number of samples can be loaded into the instrument, and the order of testing the samples can be rearranged according to a priority determined by the operator at any time. A variety of immunoassays can be performed on each sample and different immunoassays can be performed on any one sample. Information related to the type of immunoassays being performed on particular samples is collected by a bar code reader and this information is conveyed to the computer for presentation on the display. The computer tracks the progress of each immunoassay through the reaction circuit to the detection device. The time to completion for particular immunoassays as well as the concentration information for recently completed immunoassays is provided.
Such prior art analyzer interface modules are increasingly unsatisfactory as the degree of analyzer complex and automation increases. For example, many known systems for controlling an analyzer depend simply inputting the assays desired to be completed and do not allow for handling of special informational messages about the samples being analyzer or maintenance of the analyzer. In addition, it is becoming necessary to couple one or more analyzers to one or more sample preparation devices adapted to automatically perform special sample preparation operations like sample identification, aliquotting, dilution, centrifugation, etc, before a sample is presented to an analyzer for analysis. In such instances, the need for controlling the operation of the plurality of interrelated automated devices and for obtaining information about the status of a given sample or automated device exceeds the abilities of known clinical system control and information display modules Accordingly, as the state of the art advances and more demands are made on the analyzer's control and display systems there is a continuing need for a simple and rapid method to easily provide control and information display modules that are capable of rapidly determining information defining the overall status of the analytical system without an undue amount of operator training or effort obtain the needed information. It is particularly desirable to operate such an improved module without recourse to hand-held mouse-like input devices that consume valuable space in a clinical analytical system.
SUMMARY OF THE INVENTION
It is therefore an object of this invention to provide a computer interface module that allows for a user to easily and quickly access a variety of control screens and status information display screens that full describe a plurality of interrelated automated devices used for sample preparation and clinical analysis of a patient's biological sample. This and other advantages are accomplished in accordance with the invention by providing a computer interface module having a first information display screen that is directly linked to a plurality of additional information display screens containing on-line information out the operational status of plurality of interrelated automated devices as well as information describing the location of any specific sample and the status of clinical tests to be performed on the sample. The computer interface display module is thus adapted to facilitate interactions between an operator and an automated clinical analytic
Dade Behring Inc.
Gordon Paul P.
Jordan Leland K.
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