Methods and devices for detection of coagulation impairment
AssigneeCoagulo Medical Technologies, Inc.
InventorGalit H. Frydman
Life of this patent
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Abstract
Provided are methods and devices for evaluating coagulation, including the identification of a coagulation impairment such as a factor deficiency or the presence of a factor inhibitor. In various embodiments, the methods and devices measure coagulation of a sample in response to the addition of one or more coagulation factors, added at various concentrations to portions of the sample. Such coagulation measurements can be evaluated to accurately profile coagulation impairments of the sample. In additional various embodiments, point-of-care or bedside testing with a convenient, microfluidic device can be used by minimally trained personnel.
Claims50
A method of assessing coagulation in a sample from a subject, the method comprising:
- adding Factor IIa to a first portion of the sample;
- adding Factor I and Factor IIa to a second portion of the sample;
- and
- measuring clot formation for the first and second portions of the sample;
- wherein the sample is a sample of whole blood, plasma, cerebral spinal fluid, peritoneal fluid, thoracic fluid, pericardial fluid, pleural fluid, or amniotic fluid from the subject.
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A method of assessing coagulation in a sample from a subject, the method comprising:
- adding Factor I to two or more first portions of the sample, each first portion receiving the Factor I at a different concentration;
- adding Factor IIa to two or more second portions of the sample, each second portion receiving the Factor IIa at a different concentration;
- adding Factor I and Factor IIa to two or more third portions of the sample, each third portion receiving the Factor I at a different concentration and receiving the Factor IIa at the same concentration;
- and
- measuring clot formation for each of the first, second, and third portions of the sample;
- wherein the sample is a sample of whole blood, plasma, cerebral spinal fluid, peritoneal fluid, thoracic fluid, pericardial fluid, pleural fluid, or amniotic fluid from the subject.
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A microfluidic device for detecting coagulation in a sample from a subject, the microfluidic device comprising:
- a first group of channels comprising Factor I at increasing concentrations across channels of the first group;
- a second group of channels comprising Factor IIa at increasing concentrations across channels of the second group;
- and
- a third group of channels comprising Factor I at increasing concentrations across channels, and comprising Factor IIa at the same concentration across channels of the third group,
- wherein each channel in each of the first, second, and third groups of channels comprises a clot forming area that localizes clot formation, and
- wherein each of the first, second, and third groups of channels comprises at least two channels.
A method of assessing coagulation in a sample from a subject, the method comprising:
- adding Factor I and Factor IIa to a portion of the sample;
- and
- measuring clot formation for the portion of the sample;
- wherein the sample is a sample of whole blood, plasma, cerebral spinal fluid, peritoneal fluid, thoracic fluid, pericardial fluid, pleural fluid, or amniotic fluid from the subject.
A microfluidic device for detecting coagulation in a sample, the microfluidic device comprising:
- a first group of channels comprising Factor XII at increasing concentrations across channels of the first group,
- a second group of channels comprising Factor XIIa at increasing concentrations across channels of the second group,
- a third group of channels comprising Factor XI at increasing concentrations across channels of the third group,
- a fourth group of channels comprising Factor XIa at increasing concentrations across channels of the fourth group, and
- 0, 1, or more channels comprising Factor IIa, and
- 0, 1, or more additional channels comprising Factor Xa,
- wherein each channel in each of the first, second, third, and fourth groups of channels, and each of the 0, 1, or more channels comprising Factor IIa and each of the 0, 1, or more additional channels comprising Factor Xa, comprises a clot forming area that localizes clot formation, and
- wherein each of the first, second, third, and fourth groups of channels comprises at least two channels.
A microfluidic device for detecting coagulation in a sample from a subject, the microfluidic device comprising:
- a first group of channels, each channel within the first group containing on a channel surface Factor I, wherein the Factor I is present at increasing amounts across channel surfaces of the first group;
- a second group of channels, each channel within the second group containing on a channel surface Factor IIa, wherein the Factor IIa is present at increasing amounts across channel surfaces of the second group;
- and
- a third group of channels, each channel within the third group containing on a channel surface Factor I and Factor IIa, wherein the Factor I is present at increasing amounts across channel surfaces of the third group, and wherein the Factor IIa is present at the same amount across channel surfaces of the third group,
- wherein each channel in each of the first, second, and third groups of channels comprises a clot forming area that localizes clot formation, and
- wherein each of the first, second, and third groups of channels comprises at least two channels.
A microfluidic device for detecting coagulation in a sample, the microfluidic device comprising:
- a first group of channels, each channel within the first group containing on a channel surface Factor XII, wherein the Factor XII is present at increasing amounts across channel surfaces of the first group,
- a second group of channels, each channel within the second group containing on a channel surface Factor XIIa, wherein the Factor XIIa is present at increasing amounts across channel surfaces of the second group,
- a third group of channels, each channel within the third group containing on a channel surface Factor XI, wherein the Factor XI is present at increasing amounts across channel surfaces of the third group,
- a fourth group of channels, each channel within the fourth group containing on a channel surface Factor XIa, wherein the Factor XIa is present at increasing amounts across channel surfaces of the fourth group, and
- 0, 1, or more channels containing Factor IIa, and
- 0, 1, or more additional channels containing Factor Xa,
- wherein each channel in each of the first, second, third, and fourth groups of channels, and each of the 0, 1, or more channels containing Factor IIa and each of the 0, 1, or more additional channels containing Factor Xa, comprises a clot forming area that localizes clot formation, and
- wherein each of the first, second, third, and fourth groups of channels comprises at least two channels.
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Dependencies are inferred from the claim text.