EP-4735896-A1 - VACUUM MONITORING

EP4735896A1EP 4735896 A1EP4735896 A1EP 4735896A1EP-4735896-A1

Abstract

Errors in an analyzer fluidics system may be detected using systems and methods which involve obtaining a plurality of pressure measurements while a vacuum is being applied to a tube used to remove fluid from a container. These measurements may then be provided to a classification module, and the classification module may determine a status output as either a normal status output, or one of a set of error status outputs.

Inventors

WANG, ALAN
WILLETTE, Marie N.

Assignees

Beckman Coulter, Inc.

Dates

Publication Date: 20260506
Application Date: 20240626

Claims (20)

1. A method for detecting errors in an analyzer fluidics system, the method comprising: (a) moving a tip of a pipettor into a container and, while the tip of the pipettor is in the container, applying a fluid, wherein the fluid is a cleaning fluid, to at least one of an inside surface or an outside surface of the pipettor; (b) collecting the fluid in the container after it is applied to the at least one of the inside surface or the outside surface of the pipettor; (c) applying a vacuum to a tube in order to remove the fluid from the container, wherein the tube is operatively connected to the container and to a vacuum pump; (d) while the vacuum is being applied to the tube, obtaining a plurality of pressure measurements, wherein each measurement from the plurality of pressure measurements is a measurement of pressure inside the tube at a location proximate the vacuum pump; (e) providing the plurality of pressure measurements as input to a classification module; and (f) the classification module determining a status output for the analyzer fluidics system based on the plurality of pressure measurements, wherein the classification module is configured to determine, based on its input, if the status output for the analytics system is a normal status output, or one of a set of error status outputs.
2. The method of claim 1, wherein the classification module determining the status output for the analyzer fluidics system based on the plurality of pressure measurements comprises: (a) obtaining a plurality of convolution outputs based on convolving the plurality of pressure measurements with a first plurality of convolution kernels; (b) obtaining a plurality of features based on applying one or more pooling operators to the plurality of convolution outputs; and (c) providing the plurality of features to a classifier comprised by the classification module.
3. The method of claim 2, wherein the classifier is a linear classifier.
4. The method of claim 2 or claim 3, wherein: (a) the classification module determining the status output for the analyzer fluidics system based on the plurality of pressure measurements comprises generating a derived sequence of pressure measurement changes by taking first order differences of the measurements from the plurality of pressure measurements; and (b) obtaining the plurality of convolution outputs is further based on convolving the derived sequence of pressure measurement changes with a second plurality of convolution kernels.
5. The method of any one of claims 2 to 4, wherein the one or more pooling operators comprises: (a) proportion of positive values; (b) mean of positive values; (c) mean of indices of positive values; and (d) longest stretch of positive values.
6. The method of any preceding claim, wherein the set of error status outputs comprises: (a) no fluid; and (b) obstructed condition.
7. The method of any preceding claim, wherein the tube is attached to the container at a bottom of the container.
8. The method of any preceding claim, wherein the container is open such that the fluid collected in the container is exposed to atmospheric pressure.
9. An analyzer comprising: (a) a pipettor; (b) a container; (c) a vacuum pump; (d) a tube, wherein the tube is operatively connected to the vacuum pump and the container; (e) one or more processors; and (f) a non-transitory computer readable medium storing instructions for, when executed by the one or more processors, performing a fluidics system reliability improvement method with the pipettor as subject pipettor, the container as subject container, and the tube as subject tube, the fluidics system reliability improvement method comprising: (i) moving a tip of the subject pipettor into the subject container; (ii) applying fluid to at least one of an inside surface or an outside surface of the subject pipettor while the tip of the subject pipettor is in the subject container; (iii) applying a vacuum to the subject tube in order to remove the fluid from the subject container; (iv) obtaining a plurality of pressure measurements, wherein each measurement form the plurality of pressure measurements is a measurement of pressure inside the subject tube at a location proximate the vacuum pump; (v) providing the plurality of pressure measurements as input to a classification module; and (vi) the classification module determining an analyzer fluidics system status output based on the plurality of pressure measurements, wherein the classification module is configured to determine, based on its input, if the analyzer fluidics system status output is a normal status output, or one of a set of error status outputs.
10. The analyzer of claim 9, wherein the classification module determining the analyzer fluidics system status output based on the plurality of pressure measurements comprises: (a) obtaining a plurality of convolution outputs based on convolving the plurality of pressure measurements with a first plurality of convolution kernels; (b) obtaining a plurality of features based on applying one or more pooling operators to the plurality of convolution outputs; and (c) providing the plurality of features to a classifier comprised by the classification module.
11. The analyzer of claim 10, wherein the classifier is a linear' classifier.
12. The analyzer of claim 10 or claim 11, wherein: (a) the classification module determining the analyzer fluidics system status output based on the plurality of pressure measurements comprises generating a derived sequence of pressure measurement changes by taking first order differences of the measurements from the plurality of pressure measurements; and (b) obtaining the plurality of convolution outputs is further based on convolving the derived sequence of pressure measurement changes with a second plurality of convolution kernels.
13. The analyzer of any one of claims 10 to 12, wherein the one or more pooling operators comprises: (a) proportion of positive values; (b) mean of positive values; (c) mean of indices of positive values; and (d) longest stretch of positive values.
14. The analyzer of any one of claims 9 to 13, wherein the set of error status outputs comprises: (a) no fluid; and (b) obstructed condition.
15. The analyzer of any one of claims 9 to 14, wherein the tube is attached to the container at a bottom of the container.
16. The analyzer of any one of claims 9 to 15, wherein: (a) the analyzer comprises a plurality of pipettors, wherein the pipettor is comprised by the plurality of pipettors; (b) the analyzer comprises a plurality of containers, wherein the container is comprised by the plurality of containers; (c) the analyzer comprises a plurality of tubes, wherein the tube is comprised by the plurality of tubes; (d) each pipettor from the plurality of pipettors has a corresponding container from the plurality of containers and a corresponding tube from the plurality of tubes; and (e) the non-transitory computer readable medium stores instructions for, for each pipettor from the plurality of pipettors, performing the fluidics system reliability improvement method with that pipettor as the subject pipettor, the container corresponding to that pipettor as the subject container, and the tube corresponding to that pipettor as the subject tube.
17. The analyzer of any one of claims 9 to 16, wherein the container is open such that the fluid within the container is exposed to atmospheric pressure.
18. A method for detecting errors in an analyzer fluidics system, the method comprising: (a) applying a cleaning fluid to at least one of an inside surface or an outside surface of an object; (b) collecting the fluid in a container after it is applied to the at least one of the inside surface or the outside surface of the object; (c) applying, via a vacuum pump, a vacuum to a discharge passageway in fluid communication with the container in order to remove the fluid from the container; (d) while the vacuum is being applied to the discharge passageway, obtaining a plurality of pressure measurements, wherein each measurement from the plurality of pressure measurements is a measurement of pressure inside the discharge passageway at a location proximate the vacuum pump; (e) providing the plurality of pressure measurements as input to a classification module; and (f) the classification module determining a status output for the analyzer fluidics system based on the plurality of pressure measurements, wherein the classification module is configured to determine, based on its input, if the status output for the analytics system is a normal status output, or one of a set of error status outputs.
19. The method of claim 18, wherein the classification module determining the status output for the analyzer fluidics system based on the plurality of pressure measurements comprises: (a) obtaining a plurality of convolution outputs based on convolving the plurality of pressure measurements with a first plurality of convolution kernels; (b) obtaining a plurality of features based on applying one or more pooling operators to the plurality of convolution outputs; and (c) providing the plurality of features to a classifier comprised by the classification module.
20. The method of claim 19, wherein the classifier is a linear classifier.

Description

VACUUM MONITORING CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to and benefit of U.S. Provisional Application Serial No. 63/524,435, filed June 30, 2023, the contents of which are incorporated herein by reference in their entirety. BACKGROUND [0002] Clinical analyzers and/or immunoassays are well known in the art and are generally used for automated or semi- automated analysis of patient samples, such as blood, urine, spinal fluid, and the like. For testing and analyzing a patient sample, a specific component (for example, an antigen) is measured in the patient sample. Analysis of the patient sample involves general procedures, such as aspirating the patient sample from a sample vessel, dispensing the patient sample into a reaction vessel, aspirating a reagent from a reagent pack, dispensing the reagent into the reaction vessel, and so on. Such procedures are typically conducted by using one or more probes, such as a pipetting device (also referred to as a pipettor). [0003] For many aspirating and dispensing procedures, it is important that the pipettor is periodically cleaned, such as to avoid cross contamination between different patient samples or different reagents. For example, in some instances, a portion of a patient sample may contact the pipettor as the pipettor dispenses the reagent into the reaction vessel, and may then be carried from the reaction vessel by the pipettor. Additionally or alternatively, a reagent pipettor comes into contact with different reagents (within a test pack and between test packs) which, if not properly cleaned off a pipettor may result in contamination between reaction vessels, from a reaction vessel to a reagent pack, or between different portions of a reagent pack. Thus, it may be important to cleanse the pipettor before the pipettor aspirates a sample or reagent and/or before the pipettor dispenses a sample or reagent into a reaction vessel. Any remnant of a prior fluid (reagent or patient sample) may lead to an erroneous result of the analyzer. Tn one exemplary example, for cleaning the pipettor, the tip of the pipettor is moved into a wash tower, where the pipettor is sprayed by an orifice in the side of the wash tower with wash fluid (also referred to as cleaning fluid); the wash fluid is then removed from the wash tower as waste fluid via a vacuum pump and associated tubing. In some cases, there may be a failure such as an obstruction or leak in such a fluidics system that may lead to an inadequate cleaning operation, fluid spills, wasted samples, reagents, or other supplies, and/or inaccurate test results. It would be desirable to detect such errors in order to prompt an appropriate remedial action. BRIEF DESCRIPTION OF THE DRAWINGS [0004] While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which: [0005] FIG. 1A is a schematic illustration of an example of an analyzer having a wash tower for cleaning a pipettor and a vacuum pump for removing waste fluid from the wash tower, showing the analyzer during a cleaning operation; [0006] FIG. IB is a schematic illustration of the analyzer of FIG. 1 A, showing an obstruction in a tubing extending between the wash tower and the vacuum pump; [0007] FIG. 1C is a schematic illustration of the analyzer of FIG. 1A, showing a leak in the tubing extending between the wash tower and the vacuum pump; [0008] FIG. ID is a schematic illustration of the analyzer of FIG. 1A, showing an absence of fluid in the wash tower; [0009] FIG. 2 depicts a method for detecting errors in an analyzer fluidics system; and [00010] FIG. 3 illustrates a method for determining a status output. [00011] The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown. DETAILED DESCRIPTION [00012] Turning now to the drawings, FIGS. 1A-1D schematically show an example of a portion of an analyzer (10) for automated or semi-automated analysis of patient samples, such as blood, urine, spinal fluid, and the like. In the example shown, analyzer (10) includes a pipettor (12) configured to aspirate and/or dispense a fluid, such as a reagent. To that end, pipettor (12) includes a distal tip (14) configured to be moved into a first vessel, such as a reagent pack, to all