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US5482861A
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US
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Automated continuous and random access analytical system
Assignee: Abbott Laboratories
•
Filing: 1994-04-04
•
Granted: 1996-01-09
•
Expires: 2014-04-04
Abstract
Abstract An automated, continuous and random access analytical system, having apparatus and methodology capable of simultaneously performing multiple assays of liquid samples using different assay methodologies, and providing continuous and random access while performing a plurality of different assays on the same or different samples during the same time period, is disclosed. 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 dose 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 workstation, whereby a mixture of the unit dose disposable reagents and sample are achieved during incubation. The system is capable of performing more than one scheduled assay in any order, and assays where more than such scheduled assays are presented. The automated, continuous and random access analytical system is also capable of analyzing the incubated reaction mixtures independently and individually by at least two assay procedures.
Inventors
- 👤 Frederic L. Clark
- 👤 Gilbert Clift
- 👤 Kendall B. Hendrick
- 👤 William J. Kanewske, III
- 👤 Peter A. Lagocki
- 👤 Richard R. Martin
- 👤 James E. Mitchell
- 👤 Larry W. Moore
- 👤 Charles D. Pennington
- 👤 Edna S. Walker
- 👤 B. Jane Smith
- 👤 Apparao Tayi
- 👤 James A. Vaught
- 👤 David A. Yost
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-07 08:51
CPC Classifications
H; H01; H01J; H01J49/00; H01J49/02; H01J49/04; B; B01; B01L; B01L3/00; B01L3/08; B01L3/50; B01L3/502; B01L3/5025; B01L3/508; B01L3/5085; B01L3/50853; B29; B29C; B29C45/00; G; G01; G01N; G01N21/00; G01N21/01; G01N21/03; G01N21/17; G01N21/25; G01N21/251; G01N21/253; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/5302; G01N33/536; G01N33/537; G01N33/538; G01N33/542; G01N33/543; G01N33/54313; G01N35/00; G01N35/00584; G01N35/0092; G01N35/02; G01N35/025; B01L2200/00; B01L2200/14; B01L2200/142; B01L2300/00; B01L2300/04; B01L2300/041; B01L2300/042; B01L2300/043; B01L9/00; B01L9/06; B29K; B29K2995/00; B29K2995/0018; B29K2995/0031; B29K2995/0032; B29L; B29L2023/00; B29L2023/22; G01N1/00; G01N2001/002; G01N2001/007; G01N35/00029; G01N2035/00168; G01N2035/00178; G01N2035/00277; G01N2035/00287; G01N2035/00346; G01N2035/00356; G01N2035/00386; G01N2035/00455; G01N2035/00465; G01N2035/00475; G01N2035/00495; G01N2035/00524; G01N35/00722; G01N35/00732; G01N2035/00742; G01N2035/00752; G01N2035/0093; G01N35/04; G01N2035/0401; G01N2035/0403; G01N2035/0405; G01N2035/0429; G01N2035/0436; G01N2035/0439; G01N2035/0441; G01N2035/0443; G01N2035/0444; G01N2035/0446; G01N2035/0448; G01N2035/0453; G01N2035/046; G01N2035/0465; G01N35/10; G01N35/1009; G01N2035/1025; G01N35/1065; G01N2035/1076; G01N35/1081; G01N35/1083; G01N2035/1086; G01N35/0099; Y; Y10; Y10S; Y10S435/00; Y10S435/809; Y10S436/00; Y10S436/807; Y10T; Y10T436/00; Y10T436/11; Y10T436/113332; Y10T436/114165; Y10T436/114998; Y10T436/119163; Y10T436/25; Y10T436/2575
Claims Analysis
Total Claims: 62
Claim 1
Independent Claim
271 words
A method of operating an automated, continuous, and random access analytical system capable of simultaneously effecting multiple assays of a plurality of liquid samples, said method comprising the steps of: a. placing said samples onto said system; b. scheduling various assays of said plurality of liquid samples; c. preparing at least one unit dose disposable for each sample placed onto said system by (i) transferring an aliquot of said sample to a first well located in a reaction vessel having a plurality of separate and independent wells capable of receiving liquids; (ii) transferring to a second well located in said reaction vessel at least one reagent that is necessary for affecting said scheduled assay of said sample, such that reaction between said aliquot and said at least one reagent does not occur; d. transferring said reaction vessel containing said at least one unit dose disposable to a processing workstation; e. transferring at least one of said aliquot of said liquid sample or said at least one reagent in a well in said reaction vessel to a well in said reaction vessel to combine said aliquot and said at least one reagent to form a reaction mixture necessary for performing one of said assays scheduled in step b; f. repeating step c., step d., and step e. at least one time to form at least one reaction mixture in addition to the reaction mixture formed in step e.; g, independently incubating each of the aforementioned reaction mixtures simultaneously; and h. analyzing said incubated reaction mixtures independently and individually by at least two different assays that have been scheduled previously in step b.
Claim 2
Independent Claim
271 words
A method of operating an automated, continuous, and random access analytical system capable of simultaneously effecting multiple assays of a plurality of liquid samples, said method comprising the steps of: a. placing said samples onto said system; b. scheduling various assays of said plurality of liquid samples; c. preparing at least one unit dose disposable for each sample placed onto said system by (i) transferring an aliquot of said sample to a first well located in a reaction vessel having a plurality of separate and independent wells capable of receiving liquids; (ii) transferring to a second well located in said reaction vessel at least one reagent that is necessary for affecting said scheduled assay of said sample, such that reaction between said aliquot and said at least one reagent does not occur; d. transferring said reaction vessel containing said at least one unit dose disposable to a processing workstation; e. transferring at least one of said aliquot of said liquid sample or said at least one reagent in a well in said reaction vessel to a well in said reaction vessel to combine said aliquot and said at least one reagent to form a reaction mixture necessary for performing one of said assays scheduled in step b; f. repeating step c., step d., and step e. at least one time to form at least one reaction mixture in addition to the reaction mixture formed in step e.; g, independently incubating each of the aforementioned reaction mixtures simultaneously; and h. analyzing said incubated reaction mixtures independently and individually by at least two different assays that have been scheduled previously in step b.
Claim 3
Dependent Claim
86 words
A method according to claim 1 wherein at least two different assays are scheduled to be performed on said system for said plurality of liquid samples, said method providing said scheduling of said assays in advance of performance thereof, each assay having a test definition containing several timing parameters with each activity of said assay containing time values to determine which resources of said system are required and which activity is required by each of said assays, and which time values are needed by said resources.
Claim 4
Dependent Claim
28 words
A method according to claim 2 wherein step b includes scheduling of each activity to be performed in an assay before said assay is prepared in step c.
Claim 5
Dependent Claim
25 words
A method according to claim 3 wherein assay throughput as measured in tests per hour is increased in the system by processing of stat samples.
Claim 6
Dependent Claim
64 words
A method according to claim 2 wherein special priority handling through a stat procedure scheduling of a specific stat sample is employed, whereby said stat procedure scheduling interrupts assays previously scheduled in step b, thereby allowing said system to finish preparing an assay on a previously scheduled sample and then preparing to perform an assay on said stat sample through a modification of scheduling.
Claim 7
Dependent Claim
56 words
A method according to claim 2 wherein step b maximizes the number of assays said system is capable of processing per unit time by allowing time gaps between protocol steps of a given assay, said time gaps being of sufficient duration to enable protocol steps of a different assay to be performed within said time gaps.
Claim 8
Dependent Claim
16 words
A method according to claim 5 wherein calibration procedures scheduling is scheduled as a stat procedure.
Claim 9
Dependent Claim
22 words
A method according to claim 1 wherein the assay performed on said reaction mixture in said reaction vessel is a homogeneous assay.
Claim 10
Dependent Claim
22 words
A method according to claim 1 wherein the assay performed on said reaction mixture in said reaction vessel is a heterogeneous assay.
Claim 11
Dependent Claim
13 words
A method according to claim 1 wherein at least two assays are immunoassays.
Claim 12
Dependent Claim
16 words
A method according to claim 10 wherein said immunoassays are comprised of MEIA and FPIA assays.
Claim 13
Dependent Claim
16 words
A method according to claim 1 wherein said analyzing step includes optically monitoring said reaction mixtures.
Claim 14
Dependent Claim
19 words
A method according to claim 1 wherein said reaction mixtures are monitored by turbidimetric, colorimetric, fluorometric or luminescent means.
Claim 15
Dependent Claim
27 words
A method according to claim 1 wherein initiation of an assay reaction sequence is achieved simultaneously with the preparing of said at least one unit dose disposable.
Claim 16
Dependent Claim
19 words
A method according to claim 1 wherein steps c, d, e, f, g, and h are carried out simultaneously.
Claim 17
Dependent Claim
127 words
The method according to claim 1, further comprising the steps of selectively sensing the presence of said liquid samples and said reagents stored in containers with a first pipette moving vertically into said containers to aspirate said liquid samples and said reagents therefrom prior to the step of transferring said liquid samples and said reagents into said wells of said reaction vessel, and, after the step of selectively transferring said reaction vessel to said processing workstation, selectively sensing the presence of said liquid samples and said reagents in said wells of said reaction vessel with a second pipette moving vertically into said wells to aspirate said liquid samples and said reagents therefrom prior to selectively mixing said liquid samples or said reagents or both in said wells.
Claim 18
Dependent Claim
129 words
The method according to claim 1, further comprising the steps of selectively aspirating said liquid samples and said reagents stored in containers with a first fluidic system including a syringe for flushing bubbles from said first fluidic system prior to aspirating said liquid samples and said reagents therefrom and then dispensing said liquid samples and said reagents into said wells of said reaction vessel, after selectively transferring said reaction vessel to said processing workstation, selectively aspirating said liquid samples and said reagents in said wells of said vessel with a second fluidic system including a syringe for flushing bubbles from said second fluidic system prior to aspirating said liquid samples and said reagents therefrom and then selectively combining said liquid samples or said reagents or both in said wells.
Claim 19
Dependent Claim
18 words
The method according to claim 1, wherein steps e and h are performed in a temperature controlled environment.
Claim 20
Dependent Claim
46 words
The method according to claim 1, further comprising the steps of selectively combining said liquid samples and said reagents in cartridges, selectively heating assay liquids to a predetermined temperature, and dispensing said heated assay liquids into said cartridges for use in an assay to be performed.
Claim 21
Dependent Claim
30 words
The method according to claim 1, further comprising the step of providing data resulting from step h to a central processor, thereby facilitating the continuous operation of said analytical system.
Claim 22
Dependent Claim
37 words
The method according to claim 1, further comprising the steps of selectively combining said liquid samples and said reagents in cartridges, and selectively dispensing said cartridges into a carousel for effecting and analyzing a selected assay reaction.
Claim 23
Dependent Claim
57 words
The method according to claim 1, wherein said reagents are stored in reagent containers having covers, said covers being opened with an actuating device to a sufficient extent for aspirating reagents from said reagent containers, and aspirating reagents therefrom; said covers being closed with said actuating device to form an evaporatively closed seal on the reagent containers.
Claim 24
Dependent Claim
46 words
The method according to claim 1, wherein step b comprises adjusting the duration of steps e and f, independent of step c according to a predetermined protocol implemented in software, whereby said method can simultaneously perform at least two assays for a plurality of liquid samples.
Claim 25
Dependent Claim
17 words
The method according to claim 1, wherein at least one of said assays is a homogeneous assay.
Claim 26
Dependent Claim
17 words
The method according to claim 24, wherein at least one of said assays is a heterogeneous assays.
Claim 27
Dependent Claim
16 words
The method according to claim 24, wherein at least one of said assays is an immunoassay.
Claim 28
Dependent Claim
12 words
The method according to claim 26, wherein two immunoassays are being performed.
Claim 29
Dependent Claim
15 words
The method according to claim 27, wherein said two immunoassays are MEIA and FPIA assays.
Claim 30
Dependent Claim
33 words
The method according to claim 23, wherein the step of scheduling according to said predetermined protocol further comprises the step of using a given test activity to precede at least one incubating step.
Claim 31
Dependent Claim
30 words
The method according to claim 23, wherein the step of scheduling according to said predetermined protocol further comprises the step of following an incubating step with a given test activity.
Claim 32
Dependent Claim
21 words
The method according to claim 29, wherein a second incubating step immediately precedes said give activity preceding said first-mentioned incubating step.
Claim 33
Dependent Claim
33 words
The method according to claim 23, wherein the step of scheduling according to said predetermined protocol further comprises the step of performing a given test activity during the period of an incubating step.
Claim 34
Dependent Claim
30 words
The method according to claim 23, wherein the step of scheduling according to said predetermined protocol further comprises the step of sequencing steps e and f in a specific order.
Claim 35
Dependent Claim
29 words
The method according to claim 33, wherein the step of sequencing steps e and f further comprises the step of using time values to optimize performance of said assays.
Claim 36
Dependent Claim
35 words
The method according to claim 33, wherein the step of scheduling according to the predetermined protocol further comprises the step of sequencing said transfer of reaction vessels to said processing workstation in a predetermined order.
Claim 37
Dependent Claim
31 words
The method according to claim 35, further comprising the step interrupting said predetermined order of sequencing said transfer of reaction vessels and scheduling a priority transfer of reaction vessels for processing.
Claim 38
Dependent Claim
11 words
The method of claim 1, wherein step d precedes step e.
Claim 39
Dependent Claim
11 words
The method of claim 1, wherein step e precedes step d.
Claim 40
Dependent Claim
17 words
The method of claim 1, wherein said sample and said reagent are mixed in a third well.
Claim 41
Dependent Claim
21 words
The method of claim 1, wherein said sample and said reagent are mixed in said first well or said second well.
Claim 42
Independent Claim
369 words
A method of operating an automated, continuous, and random access analytical system capable of simultaneously effecting multiple assays of a plurality liquid samples, said method comprising the steps of: a. introducing sample cups, reagent packs, and reaction vessels for performing said assays onto concentric carousels of a front end carousel, said concentric carousels comprising three carousels, said reaction vessels being introduced to one of said carousels, said sample cups being introduced to a second of said carousels, and said reagent packs being introduced to a third of said carousels; b. identifying said reagent packs and said sample cups; c. scheduling said assays; d. aligning said sample cups and said reagent packs with a reaction vessel at a kitting station by rotating at least one of said carousels; e. preparing at least one unit dose disposable for each sample placed onto said system by (i) transferring an aliquot of said sample to a first well located in a reaction vessel having a plurality of separate and independent wells capable of receiving liquids; (ii) transferring to a second well located in said reaction vessel at least one reagent that is necessary for effecting a scheduled assay of the sample, such that reaction between said aliquot and said at least one reagent does not occur; f. transferring said reaction vessel containing said at least one unit dose disposable to a process carousel; g. transferring at lesat one of said aliquot of said liquid sample or said at least one reagent in a well in said reaction vessel to a well in said reaction vessel to combine said aliquot and said at least one reagent to form a reaction mixture necessary for performing one of said assays scheduled in step c; h. repeating step e, step f, and step g at least one time to form at least one reaction mixture in addition to the reaction mixture formed in step g; i. incubating said mixture of step g; j. identifying and transferring said incubated mixture in said reaction well in step h to one of at least two assay analytical stations; k. performing an analysis by reading the reaction mixture in step j and calibrating said reading; and l. recording the resulting analysis.
Claim 43
Independent Claim
369 words
A method of operating an automated, continuous, and random access analytical system capable of simultaneously effecting multiple assays of a plurality liquid samples, said method comprising the steps of: a. introducing sample cups, reagent packs, and reaction vessels for performing said assays onto concentric carousels of a front end carousel, said concentric carousels comprising three carousels, said reaction vessels being introduced to one of said carousels, said sample cups being introduced to a second of said carousels, and said reagent packs being introduced to a third of said carousels; b. identifying said reagent packs and said sample cups; c. scheduling said assays; d. aligning said sample cups and said reagent packs with a reaction vessel at a kitting station by rotating at least one of said carousels; e. preparing at least one unit dose disposable for each sample placed onto said system by (i) transferring an aliquot of said sample to a first well located in a reaction vessel having a plurality of separate and independent wells capable of receiving liquids; (ii) transferring to a second well located in said reaction vessel at least one reagent that is necessary for effecting a scheduled assay of the sample, such that reaction between said aliquot and said at least one reagent does not occur; f. transferring said reaction vessel containing said at least one unit dose disposable to a process carousel; g. transferring at lesat one of said aliquot of said liquid sample or said at least one reagent in a well in said reaction vessel to a well in said reaction vessel to combine said aliquot and said at least one reagent to form a reaction mixture necessary for performing one of said assays scheduled in step c; h. repeating step e, step f, and step g at least one time to form at least one reaction mixture in addition to the reaction mixture formed in step g; i. incubating said mixture of step g; j. identifying and transferring said incubated mixture in said reaction well in step h to one of at least two assay analytical stations; k. performing an analysis by reading the reaction mixture in step j and calibrating said reading; and l. recording the resulting analysis.
Claim 44
Dependent Claim
47 words
A method according to claim 41 wherein said front end carousel and said concentric carousels of said front end carousel are rotatably disposed for bidirectional rotational motion about a common vertical axis and said process carousel is rotatably disposed for bidirectional rotational motion about a vertical axis.
Claim 45
Dependent Claim
41 words
A method according to claim 42 wherein said front end carousel is capable of bidirectional motion to provide a bidirectional shaking motion for stirring or agitating reagents of said reagent packs after a period of inactivity of said front end carousel.
Claim 46
Dependent Claim
15 words
A method according to claim 41 wherein step e and step g are conducted simultaneously.
Claim 47
Dependent Claim
23 words
A method according to claim 41 wherein said assay being performed on said reaction mixture in said reaction vessel is a heterogeneous assay.
Claim 48
Dependent Claim
23 words
A method according to claim 41 wherein said assay being performed on said reaction mixture in said reaction vessel is a homogeneous assay.
Claim 49
Dependent Claim
13 words
A method according to claim 41 wherein at least two assays are immunoassays.
Claim 50
Dependent Claim
20 words
A method according to claim 47 wherein said immunoassays are comprised of a fluorescent polarization immunoassay and a microparticle immunoassay.
Claim 51
Dependent Claim
33 words
A method according to claim 48 wherein said microparticle immunoassay utilizes microparticles, and settling of said microparticles is substantially eliminated by providing a sufficient sucrose to microparticle diluent ratio to achieve neutral density.
Claim 52
Dependent Claim
32 words
A method according to claim 48 wherein said reaction mixture is pipetted directly from said reaction vessel on said process carousel to a microparticle immunoassay matrix for optically monitoring said reaction mixture.
Claim 53
Dependent Claim
20 words
A method according to claim 41 wherein said reagent packs are provided with covers for avoiding evaporation of said reagents.
Claim 54
Dependent Claim
25 words
A method according to claim 51 wherein said covers are provided to said reagent packs when not in use to avoid evaporation of said reagents.
Claim 55
Dependent Claim
27 words
A method according to claim 41 wherein pipetting means on said front end carousel and on said process carousel provide for aspirating and dispensing reagent and samples.
Claim 56
Dependent Claim
24 words
A method according to claim 48 wherein said fluorescence polarization immunoassay has a read sequence including a lamp simmer and a full burn mode.
Claim 57
Dependent Claim
37 words
The method according to claim 41, further comprising the step of selectively aspirating said liquid samples from said sample cups prior to selectively dispensing said liquid samples and said reagents into said wells of said reaction vessel.
Claim 58
Dependent Claim
44 words
The method according to claim 41, wherein said reaction vessel is positioned on a carousel and has a tab extending therefrom, and further comprising the step of selectively engaging said tab of said reaction vessel to move said reaction vessel to said processing workstation.
Claim 59
Dependent Claim
11 words
The method of claim 41, wherein step f precedes step g.
Claim 60
Dependent Claim
11 words
The method of claim 41, wherein step g precedes step f.
Claim 61
Dependent Claim
17 words
The method of claim 41, wherein said sample and said reagent are mixed in a third well.
Claim 62
Dependent Claim
21 words
The method of claim 41, wherein said sample and said reagent are mixed in said first well or said second well.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1999-01-08 | 1999-07-10 | 2000-01-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2003-01-08 | 2003-07-10 | 2004-01-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2007-01-08 | 2007-07-10 | 2008-01-09 | $7700.00 | Window Closed / Lapsed |