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US 2025/0347706 A1Published application
Disposable cartridge for classification of anticoagulant and method of use
AssigneeHaemonetics Corporation
InventorsGerard R. DelGiacco, Ebrahim Shafizadeh
Life of this patent
Estimating the term…
Abstract
Disposable cartridges and methods for detecting and classifying an anticoagulant at a therapeutically relevant amount or higher in a patient. The cartridges include a plurality of chambers, as well as fluidic couplings between chambers. Calcium chloride, Russel Viper Venom (RVV), an ecarin reagent, a Factor Xa reagent, protamine, kaolin, tissue factor, and combinations thereof may be included in a given chamber.
Claims17
A disposable cartridge for detecting and classifying an anticoagulant at a therapeutically relevant amount or higher in a patient, the cartridge comprising:
- (1) a first channel having:
- (a) a first receiving chamber, comprising calcium chloride, configured to receive a first sample of a blood component from the patient,
- (b) a first reagent chamber, comprising Russel Viper Venom (RVV), fluidically coupled to the first receiving chamber and configured to receive the first sample from the first receiving chamber, and
- (c) a first measurement chamber fluidically coupled to the first reagent chamber and configured to receive the first sample from the first reagent chamber, the first measurement chamber being further configured for viscoelastic analysis of the first sample received from the first reagent chamber so as to provide a first clotting measurement of the first sample received from the first reagent chamber;
- and
- (2) a second channel having:
- (d) a second receiving chamber configured to receive a second sample of the blood component from the patient,
- (e) a second reagent chamber, comprising an ecarin reagent, fluidically coupled to the second receiving chamber and configured to receive the second sample from the second receiving chamber, and
- (f) a second measurement chamber fluidically coupled to the second reagent chamber and configured to receive the second sample from the second reagent chamber, the second measurement chamber being further configured for viscoelastic analysis of the second sample received from the second reagent chamber so as to provide a second clotting measurement of the second sample received from the second reagent chamber.
6 more elements
A method for detecting a presence of and classifying an anticoagulant at a therapeutically relevant amount or higher in a patient, the method comprising:
- (A) determining a first R-time by subjecting a first sample of a blood component from the patient to a first clotting assay in the presence of RVV and calcium chloride, said first sample being admixed with the calcium chloride prior to being admixed with the RVV,
- (B) determining a second R-time by subjecting a second sample of the blood component from the patient to a second clotting assay in the presence of an ecarin reagent, and
- (C) determining a third R-time by subjecting a third sample of the blood component from the patient to a third clotting assay in the presence of a Factor Xa reagent and calcium chloride, said third sample being admixed with the Factor Xa reagent and the calcium chloride concurrently;
- and
- comparing:
- (i) the first R-time to a first control R-time, said first control R-time being derived from a first set of control blood component samples, each control blood component sample of the first set having been obtained from a control patient known to lack each of a Factor Xa inhibitor, a DTI, and heparin at a therapeutically relevant amount or higher,
- (ii) the second R-time to a second control R-time, said second control R-time being derived from a second set of control blood component samples, each control blood component sample of the second set having been obtained from a control patient known to lack a direct thrombin inhibitor (DTI) at a therapeutically relevant amount or higher, and
- (iii) the third R-time to a third control R-time, said third control R-time being derived from a third set of control blood component samples, each control blood component sample of the third set having been obtained from a control patient known to lack each of a Factor Xa inhibitor, a DTI, heparin, and a vitamin K antagonist at a therapeutically relevant amount or higher;
- wherein:
- (a) the first R-time greater than the first control R-time, the second R-time less than or equal to the second control R-time, and the third R-time greater than the third control R-time indicates the presence of the Factor Xa inhibitor at or above a therapeutically relevant amount in the patient;
- (b) the first R-time greater than the first control R-time, the second R-time greater than the second control R-time, and the third R-time greater than the third control R-time indicates the presence of the DTI at or above a therapeutically relevant amount in the patient;
- (c) the first R-time less than or equal to the first control R-time, the second R-time less than or equal to the second control R-time, the third R-time greater than the third control R-time indicates the presence of the vitamin K antagonist at or above a therapeutically relevant amount in the patient.
9 more elements
A method for detecting a presence of and classifying an anticoagulant at a therapeutically relevant amount or higher in a patient, the method comprising:
- (A) determining a first R-time by subjecting a first sample of a blood component from the patient to a first clotting assay in the presence of RVV and calcium chloride, said first sample being admixed with the calcium chloride prior to being admixed with the RVV,
- (B) determining a second R-time by subjecting a second sample of the blood component from the patient to a second clotting assay in the presence of an ecarin reagent,
- (C) determining a third R-time by subjecting a third sample of the blood component from the patient to a third clotting assay in the presence of a Factor Xa reagent and calcium chloride, said third sample being admixed with the Factor Xa reagent and the calcium chloride concurrently, and
- (D) determining a fourth R-time by subjecting a fourth sample of the blood component from the patient to a clotting assay in the presence of protamine;
- and
- comparing:
- (i) the first R-time to a first control R-time, said first control R-time being derived from a first set of control blood component samples, each control blood component sample of the first set having been obtained from a control patient known to lack each of a Factor Xa inhibitor, a DTI, and heparin at a therapeutically relevant amount or higher,
- (ii) the second R-time to a second control R-time, said second control R-time being derived from a second set of control blood component samples, each control blood component sample of the second set having been obtained from a control patient known to lack a direct thrombin inhibitor (DTI) at a therapeutically relevant amount or higher,
- (iii) the third R-time to a third control R-time, said third control R-time being derived from a third set of control blood component samples, each control blood component sample of the third set having been obtained from a control patient known to lack each of a Factor Xa inhibitor, a DTI, heparin, and a vitamin K antagonist at a therapeutically relevant amount or higher, and
- (iv) the fourth R-time to a fourth control R-time, said fourth control R-time being derived from a fourth set of control blood component samples, each control blood component sample of the fourth set having been obtained from a control patient known to lack each of a Factor Xa inhibitor, a DTI, a vitamin K antagonist, and heparin, at a therapeutically relevant amount or higher;
- wherein:
- (a) the first R-time greater than the first control R-time, the second R-time less than or equal to the second control R-time, the third R-time greater than the third control R-time, and the fourth R-time greater than or equal to the fourth control R-time indicates the presence of the Factor Xa inhibitor at or above a therapeutically relevant amount in the patient;
- (b) the first R-time greater than the first control R-time, the second R-time greater than the second control R-time, the third R-time greater than the third control R-time, and the fourth R-time greater than or equal to the fourth control R-time indicates the presence of the DTI at or above a therapeutically relevant amount in the patient;
- (c) the first R-time less than or equal to the first control R-time, the second R-time less than or equal to the second control R-time, the third R-time greater than the third control R-time, and the fourth R-time greater than or equal to the fourth control R-time indicates the presence of the vitamin K antagonist at or above a therapeutically relevant amount in the patient;
- (d) the first R-time greater than the first control R-time, the second R-time less than or equal to the second control R-time, the third R-time greater than the third control R-time, and the fourth R-time less than the fourth control R-time indicates the presence of heparin at or above a therapeutically relevant amount in the patient.
12 more elements
A method for detecting a presence of and classifying an anticoagulant at a therapeutically relevant amount or higher in a patient, the method comprising:
- (A) determining a first R-time by subjecting a first sample of a blood component from the patient to a first clotting assay in the presence of RVV and calcium chloride, said first sample being admixed with the calcium chloride prior to being admixed with the RVV,
- (B) determining a second R-time by subjecting a second sample of the blood component from the patient to a second clotting assay in the presence of an ecarin reagent,
- (C) determining a third R-time by subjecting a third sample of the blood component from the patient to a third clotting assay in the presence of a Factor Xa reagent and calcium chloride, said third sample being admixed with the Factor Xa reagent and the calcium chloride concurrently, and
- (D) determining a fourth R-time by subjecting a fourth sample of the blood component from the patient to a clotting assay in the presence of a heparinase reagent, kaolin, tissue factor, and calcium chloride, said fourth sample of the blood component from the patient being admixed with the heparinase reagent prior to being admixed with the kaolin, tissue factor, and calcium chloride;
- and
- comparing:
- (i) the first R-time to a first control R-time, said first control R-time being derived from a first set of control blood component samples, each control blood component sample of the first set having been obtained from a control patient known to lack each of a Factor Xa inhibitor, a DTI, and heparin at a therapeutically relevant amount or higher,
- (ii) the second R-time to a second control R-time, said second control R-time being derived from a second set of control blood component samples, each control blood component sample of the second set having been obtained from a control patient known to lack a direct thrombin inhibitor (DTI) at a therapeutically relevant amount or higher,
- (iii) the third R-time to a third control R-time, said third control R-time being derived from a third set of control blood component samples, each control blood component sample of the third set having been obtained from a control patient known to lack each of a Factor Xa inhibitor, a DTI, heparin, and a vitamin K antagonist at a therapeutically relevant amount or higher;
- (iv) the fourth R-time to a fourth control R-time, said fourth control R-time being derived from a fourth set of control blood component samples, each control blood component sample of the fourth set having been obtained from a control patient known to have a control anticoagulant selected from the group consisting of a Factor Xa inhibitor, a DTI, a vitamin K antagonist, and combinations thereof, at a therapeutically relevant amount or higher, and
- (v) the second R-time to a fifth control R-time, said fifth control R-time being derived from a fifth set of control blood component samples, each control blood component sample of the fifth set having been obtained from a control patient known to lack heparin at a therapeutically relevant amount or higher;
- wherein:
- (a) the first R-time greater than the first control R-time, the second R-time less than or equal to the second control R-time, the third R-time greater than the third control R-time, and the fourth R-time greater than or equal to the fourth control R-time indicates the presence of the Factor Xa inhibitor at or above a therapeutically relevant amount in the patient;
- (b) the first R-time greater than the first control R-time, the second R-time greater than the second control R-time, the third R-time greater than the third control R-time, and the fourth R-time greater than or equal to the fourth control R-time indicates the presence of the DTI at or above a therapeutically relevant amount in the patient;
- (c) the first R-time less than or equal to the first control R-time, the second R-time less than or equal to the second control R-time, the third R-time greater than the third control R-time, and the fourth R-time greater than or equal to the fourth control R-time indicates the presence of the vitamin K antagonist at or above a therapeutically relevant amount in the patient;
- (d) the first R-time greater than the first control R-time, the second R-time greater than the fifth control R-time, the third R-time greater than the third control R-time, and the fourth R-time less than the fourth control R-time indicates the presence of heparin at or above a therapeutically relevant amount in the patient.
13 more elements
Dependencies are inferred from the claim text.