US5708591A
Expired / Lapsed
US
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Method and apparatus for predicting the presence of congenital and acquired imbalances and therapeutic conditions
Assignee: Biomerieux SA
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Filing: 1995-06-07
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Granted: 1998-01-13
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Expires: 2015-06-07
Abstract
Abstract A method and apparatus are disclosed for predicting the presence of at least one congenital or acquired imbalance or therapeutic condition associated with thrombosis/hemostasis from at least one time-dependent measurement profile. At least one time-dependent measurement on an unknown sample is performed and a respective property of said sample is measured over time so as to derive a time-dependent measurement profile. A set of a plurality of predictor variables are defined which sufficiently define the data of the time-dependent measurement profile. A model is then derived that represents the relationship between the congenital or acquired imbalance or therapeutic condition, and the set of predictor variables. Subsequently, the model is utilized to predict the existence of the congenital or acquired imbalance or therapeutic condition in the unknown sample.
Inventors
- 👤 Thomas B. Givens
- 👤 Paul Braun
- 👤 Timothy J. Fischer
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-03 15:45
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/483; G01N33/487; G01N33/49; G01N33/4905; C; C07; C07K; C07K16/00; C07K16/18; G01N33/50; G01N33/86; G01N35/00; G16; G16H; G16H10/00; G16H10/40; G16H50/00; G16H50/50; G01N2800/00; G01N2800/22; G01N2800/226; G01N2800/38; G01N2800/385; G16H10/60; G16H50/20
Claims Analysis
Total Claims: 40
Claim 1
Independent Claim
225 words
A method for predicting the presence of at least one congenital or acquired imbalance or therapeutic condition associated with thrombosis/hemostasis from at least one time-dependent measurement profile, comprising: a) performing at least one time-dependent measurement on an unknown sample and measuring a respective property over time so as to derive a time-dependent measurement profile; b) defining a set of a plurality of predictor variables which sufficiently define the data of the time-dependent measurement profile; c) deriving a model that represents the relationship between the congenital or acquired imbalance or therapeutic condition, and the set of predictor variables; and d) utilizing the model of step c) to predict the existence of the congenital or acquired imbalance or therapeutic condition in the unknown sample; wherein said set of predictor variables includes a plurality of: a minimum of the first derivative of the profile, a time index of the minimum of the first derivative, a minimum of the second derivative of the profile, a time index of the minimum of the second derivative, a maximum of the second derivative of the profile, a time index of the maximum of the second derivative, an overall change in the coagulation parameter during the time-dependent measurement on the unknown sample, a clotting time, a slope of the profile prior to clot formation, and a slope of the profile after clot formation.
Claim 2
Independent Claim
225 words
A method for predicting the presence of at least one congenital or acquired imbalance or therapeutic condition associated with thrombosis/hemostasis from at least one time-dependent measurement profile, comprising: a) performing at least one time-dependent measurement on an unknown sample and measuring a respective property over time so as to derive a time-dependent measurement profile; b) defining a set of a plurality of predictor variables which sufficiently define the data of the time-dependent measurement profile; c) deriving a model that represents the relationship between the congenital or acquired imbalance or therapeutic condition, and the set of predictor variables; and d) utilizing the model of step c) to predict the existence of the congenital or acquired imbalance or therapeutic condition in the unknown sample; wherein said set of predictor variables includes a plurality of: a minimum of the first derivative of the profile, a time index of the minimum of the first derivative, a minimum of the second derivative of the profile, a time index of the minimum of the second derivative, a maximum of the second derivative of the profile, a time index of the maximum of the second derivative, an overall change in the coagulation parameter during the time-dependent measurement on the unknown sample, a clotting time, a slope of the profile prior to clot formation, and a slope of the profile after clot formation.
Claim 3
Dependent Claim
20 words
A method according to claim 1, wherein said at least one time-dependent measurement profile is at least one optical profile.
Claim 4
Dependent Claim
24 words
A method according to claim 2, wherein said at least one optical profile is provided by an automated analyzer for thrombosis and hemostasis testing.
Claim 5
Dependent Claim
47 words
A method according to claim 2, wherein a plurality of optical measurements at one or more wavelengths are taken over time so as to derive said at least one optical profile, said optical measurements corresponding to changes in light scattering and/or light absorption in the unknown sample.
Claim 6
Dependent Claim
41 words
A method according to claim 2, wherein a plurality of optical measurements are taken over time so as to derive said at least one optical profile, and wherein said plurality of optical measurements are each normalized to a first optical measurement.
Claim 7
Dependent Claim
82 words
A method according to claim 3, wherein in step a) said at least one optical profile is provided automatically by said analyzer, whereby said unknown sample is automatically removed by an automated probe from a sample container to a test well, one or more reagents are automatically added to said test well so as to initiate said property changes within said sample, and the development of said property over time is automatically optically monitored so as to derive said optical data profile.
Claim 8
Dependent Claim
35 words
A method according to claim 6, wherein after step d), a predicted congenital or acquired imbalance or therapeutic condition is automatically stored in a memory of said automated analyzer and/or displayed on said automated analyzer.
Claim 9
Dependent Claim
30 words
A method according to claim 6, wherein in step d), one or more assays for confirming the existence of said congenital or acquired imbalance or therapeutic condition is automatically performed.
Claim 10
Dependent Claim
43 words
A method according to claim 8, wherein said one or more confirming assays are automatically ordered and performed on said analyzer, with results of said one or more assays being stored in a memory of said automated analyzer and/or displayed on said analyzer.
Claim 11
Dependent Claim
30 words
A method according to claim 1, further comprising: before step a), providing a set of data from known samples, which data is used in step c) for deriving said model.
Claim 12
Dependent Claim
24 words
A method according to claim 10, wherein said data from known samples is provided by performing a plurality of assays on said known samples.
Claim 13
Dependent Claim
16 words
A method according to claim 10, wherein said model of step c) is a neural network.
Claim 14
Dependent Claim
20 words
A method according to claim 1, wherein said relationship in step c) is determined via at least one automated algorithm.
Claim 15
Dependent Claim
26 words
A method according to claim 13, wherein said model is a multilayer perceptron, and wherein said at least one algorithm is a back propagation learning algorithm.
Claim 16
Dependent Claim
23 words
A method according to claim 1, wherein in step a), a plurality of time-dependent measurement profiles are derived for use in step b).
Claim 17
Dependent Claim
32 words
A method according to claim 15, wherein said plurality of time dependent measurement profiles includes at least two profiles from assays initiated with PT reagents, APTT reagents, fibrinogen reagents and TT reagents.
Claim 18
Dependent Claim
18 words
A method according to claim 1, wherein three or more of said predictor variables are within said set.
Claim 19
Dependent Claim
18 words
A method according to claim 17, wherein more than three of said predictor variables are within said set.
Claim 20
Dependent Claim
45 words
A method according to claim 1, wherein said unknown sample is a sample from a medical patient, and wherein in step d), both said model and additional patient medical data are utilized for predicting the existence of said congenital or acquired imbalance or therapeutic condition.
Claim 21
Independent Claim
249 words
An apparatus for performing at least one time-dependent measurement on an unknown sample to derive at least one time-dependent measurement profile, and predicting the presence of at least one congenital or acquired imbalance or therapeutic condition associated with thrombosis/hemostasis from the at least one time-dependent measurement profile, comprising: means for performing at least one time-dependent measurement on an unknown sample and measuring a respective property over time so as to derive a time-dependent measurement profile; means for defining a set of a plurality of predictor variables which sufficiently define the data of the time-dependent measurement profile; means for deriving a model that represents the relationship between the congenital or acquired imbalance or therapeutic condition, and the set of predictor variables; and means for utilizing the model of step c) to predict the existence of the congenital or acquired imbalance or therapeutic condition in the unknown sample; wherein said set of predictor variables includes a plurality of: a minimum of the first derivative of the profile, a time index of the minimum of the first derivative, a minimum of the second derivative of the profile, a time index of the minimum of the second derivative, a maximum of the second derivative of the profile, a time index of the maximum of the second derivative, an overall change in the coagulation parameter during the time-dependent measurement on the unknown sample, a clotting time, a slope of the profile prior to clot information, and a slope of the profile after clot formation.
Claim 22
Independent Claim
249 words
An apparatus for performing at least one time-dependent measurement on an unknown sample to derive at least one time-dependent measurement profile, and predicting the presence of at least one congenital or acquired imbalance or therapeutic condition associated with thrombosis/hemostasis from the at least one time-dependent measurement profile, comprising: means for performing at least one time-dependent measurement on an unknown sample and measuring a respective property over time so as to derive a time-dependent measurement profile; means for defining a set of a plurality of predictor variables which sufficiently define the data of the time-dependent measurement profile; means for deriving a model that represents the relationship between the congenital or acquired imbalance or therapeutic condition, and the set of predictor variables; and means for utilizing the model of step c) to predict the existence of the congenital or acquired imbalance or therapeutic condition in the unknown sample; wherein said set of predictor variables includes a plurality of: a minimum of the first derivative of the profile, a time index of the minimum of the first derivative, a minimum of the second derivative of the profile, a time index of the minimum of the second derivative, a maximum of the second derivative of the profile, a time index of the maximum of the second derivative, an overall change in the coagulation parameter during the time-dependent measurement on the unknown sample, a clotting time, a slope of the profile prior to clot information, and a slope of the profile after clot formation.
Claim 23
Dependent Claim
40 words
An apparatus according to claim 20, wherein said means for performing at least one time-dependent measurement comprises an optical system for performing at least one optical measurement over time and so as to derive an at least one optical profile.
Claim 24
Dependent Claim
21 words
An apparatus according to claim 21, wherein said optical system is part of an automated analyzer for thrombosis and hemostasis testing.
Claim 25
Dependent Claim
53 words
An apparatus according to claim 21, wherein said optical means comprises a means for performing a plurality of optical measurements at one or more wavelengths over time so as to derive said at least one optical profile, said optical measurements corresponding to changes in light scattering and/or light absorption in the unknown sample.
Claim 26
Dependent Claim
45 words
An apparatus according to claim 21, wherein in said optical system, a plurality of optical measurements are taken over time so as to derive said at least one optical profile, and wherein said plurality of optical measurements are each normalized to a first optical measurement.
Claim 27
Dependent Claim
90 words
An apparatus according to claim 22, which is an automated analyzer for thrombosis and hemostasis testing, and wherein said at least one optical profile is provided automatically by said analyzer, whereby said unknown sample is automatically removed by an automated probe from a sample container to a test well, one or more reagents are automatically added to said test well so as to initiate said property changes within said sample, and the development of said property over time is automatically optically monitored so as to derive said optical data profile.
Claim 28
Dependent Claim
46 words
An apparatus according to claim 25, further comprising at least one of a memory and a display wherein a predicted congenital or acquired imbalance or therapeutic condition is automatically stored in said memory of said automated analyzer and/or displayed on said display of said automated analyzer.
Claim 29
Dependent Claim
29 words
An apparatus according to claim 25, further comprising means for automatically performing one or more assays for confirming the existence of said congenital or acquired imbalance or therapeutic condition.
Claim 30
Dependent Claim
58 words
An apparatus according to claim 27, wherein said means for performing one or more confirming assays is an automatic performing means wherein said confirming assays are automatically ordered and performed on said analyzer, with results of said one or more assays being stored in a memory of said automated analyzer and/or displayed on a display of said analyzer.
Claim 31
Dependent Claim
29 words
An apparatus according to claim 20, further comprising means for providing a set of data from known samples, which data is used in step c) for deriving said model.
Claim 32
Dependent Claim
27 words
An apparatus, according to claim 29, wherein said data from known samples is provided by said means for performing a plurality of assays on said known samples.
Claim 33
Dependent Claim
26 words
An apparatus according to claim 29, wherein said means for deriving a model is a means for deriving a model by means of a neural network.
Claim 34
Dependent Claim
27 words
An apparatus according to claim 20, wherein said relationship determined by said deriving means comprises a means for determining said relationship via at least one automated algorithm.
Claim 35
Dependent Claim
26 words
An apparatus according to claim 32, wherein said model is a multilayer perceptron, and wherein said at least one algorithm is a back propagation learning algorithm.
Claim 36
Dependent Claim
26 words
An apparatus according to claim 20, wherein said means for performing at least one time-dependent measurement is capable of performing a plurality of time-dependent measurement profiles.
Claim 37
Dependent Claim
40 words
An apparatus according to claim 34, wherein said means for performing a plurality of time dependent measurement profiles includes a means for performing at least two profiles from assays initiated with PT reagents, APTT reagents, fibrinogen reagents and TT reagents.
Claim 38
Dependent Claim
18 words
An apparatus according to claim 20, wherein three or more of said predictor variables are within said set.
Claim 39
Dependent Claim
18 words
An apparatus according to claim 36, wherein more than three of said predictor variables are within said set.
Claim 40
Dependent Claim
48 words
An apparatus according to claim 20, wherein said unknown sample is a sample from a medical patient, and wherein said utilizing means comprising a means for utilizing both said model and additional patient medical data for predicting the existence of said congenital or acquired imbalance or therapeutic condition.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2001-01-12 | 2001-07-14 | 2002-01-13 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2005-01-12 | 2005-07-14 | 2006-01-13 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2009-01-12 | 2009-07-14 | 2010-01-13 | $7700.00 | Window Closed / Lapsed |