Microfabricated device with micro-environment sensors for assaying coagulation in fluid samples
First Claim
1. A sample analysis cartridge comprising:
- an inlet chamber configured to receive a biological sample; and
a conduit fluidically connected to the inlet chamber and configured to receive the biological sample from the inlet chamber, the conduit comprising;
a micro-environment prothrombin time (PT) sensor; and
a micro-environment activated partial thromboplastin time (aPTT) sensor;
wherein the micro-environment PT sensor and the micro-environment aPTT sensor each comprise a polymer layer and diagnostic reagents configured in such a way that any reaction occurring in an immediate vicinity of each of the micro-environment sensors in a manner sufficient to achieve a signal at each of the micro-environment sensors will not detectably interfere or impact another reaction occurring at an adjacent sensor during normal usage,wherein the micro-environment PT sensor comprises PT diagnostic reagents, comprising at least one reagent for inducing extrinsic coagulation pathway in the biological sample, andwherein the micro-environment activated aPTT sensor comprises aPTT diagnostic reagents, comprising at least one reagent for inducing intrinsic coagulation pathway in the biological sample.
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Accused Products
Abstract
The present invention relates to sample analysis cartridges comprising micro-environment sensors and methods for assaying coagulation in a fluid sample applied to the micro-environment sensors, and in particular, to performing coagulation assays using micro-environment sensors in a point of care sample analysis cartridge. For example, the present invention may be directed to a sample analysis cartridge including an inlet chamber configured to receive a biological sample, and a conduit fluidically connected to the inlet chamber and configured to receive the biological sample from the inlet chamber. The conduit may include a micro-environment prothrombin time (PT) sensor, and a micro-environment activated partial thromboplastin time (aPTT) sensor.
95 Citations
24 Claims
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1. A sample analysis cartridge comprising:
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an inlet chamber configured to receive a biological sample; and a conduit fluidically connected to the inlet chamber and configured to receive the biological sample from the inlet chamber, the conduit comprising; a micro-environment prothrombin time (PT) sensor; and a micro-environment activated partial thromboplastin time (aPTT) sensor; wherein the micro-environment PT sensor and the micro-environment aPTT sensor each comprise a polymer layer and diagnostic reagents configured in such a way that any reaction occurring in an immediate vicinity of each of the micro-environment sensors in a manner sufficient to achieve a signal at each of the micro-environment sensors will not detectably interfere or impact another reaction occurring at an adjacent sensor during normal usage, wherein the micro-environment PT sensor comprises PT diagnostic reagents, comprising at least one reagent for inducing extrinsic coagulation pathway in the biological sample, and wherein the micro-environment activated aPTT sensor comprises aPTT diagnostic reagents, comprising at least one reagent for inducing intrinsic coagulation pathway in the biological sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A sample analysis cartridge comprising:
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an inlet chamber configured to receive a biological sample; a first conduit fluidically connected to the inlet chamber and configured to receive the biological sample from the inlet chamber, the first conduit comprising a junction configured to split the biological sample into at least first and second segments; a second conduit fluidically connected to the first conduit at the junction and configured to receive the first segment of the biological sample, the second conduit comprising a prothrombin time (PT) reagent and a PT sensor comprising a first transducer; and a third conduit fluidically connected to the first conduit at the junction and configured to receive the second segment of the biological sample, the third conduit comprising an activated partial thromboplastin time (aPTT) reagent and an aPTT sensor comprising a second transducer, wherein one of the second and third conduits comprises a flow restrictor positioned upstream of the PT sensor or the aPTT sensor. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19)
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20. A sample analysis cartridge comprising:
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a conduit comprising a micro-environment coagulation sensor and a blood chemistry sensor; and a pump configured to move a biological sample within the conduit to contact the micro-environment coagulation sensor and the blood chemistry sensor at substantially same time, wherein the micro-environment coagulation sensor comprises a polymer layer and diagnostic reagents configured in such a way that any reaction occurring in an immediate vicinity of the micro-environment coagulation sensor in a manner sufficient to achieve a signal at the micro-environment coagulation sensor will not detectably interfere or impact another reaction occurring at an adjacent sensor during normal usage, and wherein the diagnostic reagents comprise at least one reagent for inducing a coagulation pathway in the biological sample. - View Dependent Claims (21)
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22. A sample analysis cartridge comprising:
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a conduit comprising at least one micro-environment coagulation sensor, a pH sensor, a partial pressure CO2 sensor, a partial pressure O2 sensor, and a lactate sensor; and a pump configured to move a biological sample within the conduit to contact each of the at least one coagulation sensor, the pH sensor, the partial pressure CO2 sensor, the partial pressure O2 sensor, and the lactate sensor, wherein the at least one micro-environment coagulation sensor comprises a polymer layer and diagnostic reagents configured in such a way that any reaction occurring in an immediate vicinity of the at least one micro-environment coagulation sensor in a manner sufficient to achieve a signal at the at least one micro-environment coagulation sensor will not detectably interfere or impact another reaction occurring at an adjacent sensor during normal usage, and wherein the diagnostic reagents comprise at least one reagent for inducing a coagulation pathway in the biological sample. - View Dependent Claims (23)
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24. A sample analysis cartridge comprising:
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an inlet chamber configured to receive a biological sample; and a conduit fluidically connected to the inlet chamber and configured to receive the biological sample from the inlet chamber, the conduit comprising; a micro-environment prothrombin time (PT) sensor; and a micro-environment activated partial thromboplastin time (aPTT) sensor, wherein the micro-environment PT sensor comprises a first polymer layer with PT diagnostic reagents integrated within, coated over and/or positioned adjacent to the first polymer layer, and wherein the micro-environment aPTT sensor comprises a second polymer layer with aPTT diagnostic reagents integrated within, coated over and/or positioned adjacent to the second polymer layer.
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Specification