Methods for evaluation of hemostasis
First Claim
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1. A method for evaluating hemostasis in a subject, comprising:
- providing a disposable cartridge including a fluid pathway comprising an inlet for receiving a blood sample of the subject, wherein the inlet communicates with an inlet channel in the cartridge, the inlet channel communicating with at least a first channel and a second channel, wherein the first channel is in fluid communication with a first test chamber and the second channel is in fluid communication with a second test chamber, and wherein the disposable cartridge includes a thermally conductive portion;
introducing the blood sample into the inlet and then the inlet channel of the cartridge, wherein a first portion of the blood sample is received in the first channel and the first test chamber and a second portion of the blood sample is received in the second channel and the second test chamber;
adjusting the temperature of the blood sample, or a portion thereof, along the thermally conductive portion;
allowing the first portion of the blood sample to mix with a first reagent or combination of reagents to produce a first test sample;
allowing the second portion of the blood sample to mix with a second reagent or combination of reagents to form a second test sample;
initiating displacement within the first test sample;
interrogating the first test sample in the first test chamber to measure a first change in mechanical properties of the first test sample;
determining, by a processor, a first curve associated with stiffness of the first test sample as a function of time;
determining at least one parameter including a first parameter selected from the group consisting of clot time, clot stiffness, clot formation rate, and lysis time from the first curve;
initiating displacement within the second test sample;
interrogating the second test sample in the second test chamber to measure a second change in mechanical properties of the second test sample;
determining, by the processor, a second curve associated with stiffness of the first test sample as a function of time; and
determining at least one parameter including a second parameter selected from the group consisting of clot time, clot stiffness, clot formation rate, and lysis time from the second curve;
wherein said first parameter, said second parameter, or a combination thereof provides an indication of a state of hemostasis in the subject; and
wherein the interrogation to determine the first parameter, the second parameter, or a combination thereof is based on a viscoelastic measurement of the blood sample.
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Abstract
Provided are devices, systems and methods for evaluation of hemostasis. In some embodiments, an apparatus is disclosed comprising a housing; a plurality of test chambers located in the housing, the plurality of test chambers including chambers configured for measurements via a system that interrogates one or more viscoelastic properties of test samples in the test chambers, wherein the one or more viscoelastic properties is used to characterize dynamics of coagulation and/or fibrinolysis.
176 Citations
45 Claims
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1. A method for evaluating hemostasis in a subject, comprising:
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providing a disposable cartridge including a fluid pathway comprising an inlet for receiving a blood sample of the subject, wherein the inlet communicates with an inlet channel in the cartridge, the inlet channel communicating with at least a first channel and a second channel, wherein the first channel is in fluid communication with a first test chamber and the second channel is in fluid communication with a second test chamber, and wherein the disposable cartridge includes a thermally conductive portion; introducing the blood sample into the inlet and then the inlet channel of the cartridge, wherein a first portion of the blood sample is received in the first channel and the first test chamber and a second portion of the blood sample is received in the second channel and the second test chamber; adjusting the temperature of the blood sample, or a portion thereof, along the thermally conductive portion; allowing the first portion of the blood sample to mix with a first reagent or combination of reagents to produce a first test sample; allowing the second portion of the blood sample to mix with a second reagent or combination of reagents to form a second test sample; initiating displacement within the first test sample; interrogating the first test sample in the first test chamber to measure a first change in mechanical properties of the first test sample; determining, by a processor, a first curve associated with stiffness of the first test sample as a function of time; determining at least one parameter including a first parameter selected from the group consisting of clot time, clot stiffness, clot formation rate, and lysis time from the first curve; initiating displacement within the second test sample; interrogating the second test sample in the second test chamber to measure a second change in mechanical properties of the second test sample; determining, by the processor, a second curve associated with stiffness of the first test sample as a function of time; and determining at least one parameter including a second parameter selected from the group consisting of clot time, clot stiffness, clot formation rate, and lysis time from the second curve; wherein said first parameter, said second parameter, or a combination thereof provides an indication of a state of hemostasis in the subject; and wherein the interrogation to determine the first parameter, the second parameter, or a combination thereof is based on a viscoelastic measurement of the blood sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
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26. A method for evaluating hemostasis in a subject, comprising:
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feeding a blood sample of the subject to a disposable cartridge through an inlet in the cartridge, wherein the blood sample is directed through the inlet into an inlet channel in the cartridge, wherein a first portion of the blood sample flows from the inlet channel into a first channel and a first test chamber and a second portion of the blood sample flows into a second channel and a second test chamber, and wherein the disposable cartridge includes a thermally conductive portion therein; adjusting the temperature of the blood sample, or a portion thereof, along the thermally conductive portion; mixing the first portion of the blood sample with a first reagent or combination of reagents to produce a first test sample, wherein the first reagent or combination of reagents includes an activator of coagulation that activates the first test sample via an intrinsic pathway of coagulation; mixing the second portion of the blood sample with a second reagent or combination of reagents to form a second test sample, wherein the second reagent or combination of reagents includes an activator of coagulation that activates the second test sample via an extrinsic pathway of coagulation; initiating displacement within the first test sample; interrogating the first test sample in the first test chamber to measure a first change in mechanical properties of the first test sample; determining at least one parameter including a first parameter selected from the group consisting of clot time, clot stiffness, clot formation rate, and lysis time from said first change in mechanical properties; initiating displacement within the second test sample; interrogating the second test sample in the second test chamber to measure a second change in mechanical properties of the second test sample; and determining at least one parameter including a second parameter selected from the group consisting of clot time, clot stiffness, clot formation rate, and lysis time from said second change in mechanical properties; wherein said first parameter, said second parameter, or a combination thereof provides an indication of a state of hemostasis in the subject; and wherein the interrogation to determine the first parameter and/or the second parameter is based on a viscoelastic measurement of the blood sample. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38)
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39. A method for evaluating hemostasis of a subject, comprising:
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providing a disposable cartridge including a fluid pathway comprising an inlet for receiving a blood sample, wherein the inlet communicates with an inlet channel in the cartridge, the inlet channel communicating with at least a first channel and a second channel, wherein the first channel is in fluid communication with a first test chamber and the second channel is in fluid communication with a second test chamber, and wherein the disposable cartridge includes a thermally conductive portion; introducing the blood sample into the inlet and then the inlet channel of the cartridge, wherein a first portion of the blood sample is received in the first channel and the first test chamber and a second portion of the blood sample is received in the second channel and the second test chamber; adjusting the temperature of the blood sample, or a portion thereof, along the thermally conductive portion; applying a pressure differential from a source external to the disposable cartridge to draw at least a portion of the blood sample to at least one of the first test chamber and the second test chamber; preventing the blood sample from flowing out of the disposable cartridge; allowing the first portion of the blood sample to mix with a first reagent or combination of reagents to produce a first test sample; allowing the second portion of the blood sample to mix with a second reagent or combination of reagents to form a second test sample; interrogating the first test sample in the first test chamber to determine at least one parameter including a first parameter selected from the group consisting of clot time, clot stiffness, clot formation rate, and lysis time; and interrogating the second test sample in the second test chamber to determine at least one parameter including a second parameter selected from the group consisting of clot time, clot stiffness, clot formation rate, and lysis time; wherein said first parameter, said second parameter, or a combination thereof provides an indication of a state of hemostasis in the subject; and wherein the interrogation to determine the first parameter, the second parameter, or a combination thereof is based on a viscoelastic measurement of the blood sample. - View Dependent Claims (40, 41, 42, 43, 44, 45)
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Specification