Devices, systems and methods for evaluation of hemostasis

A device configured as a disposable cartridge, the device comprising:

• a housing;
• a plurality of test chambers, wherein the plurality of test chambers include at least a first test chamber and a second test chamber that are each at least partially defined by the housing, wherein the first test chamber and the second test chamber are each designed to receive a test sample of blood and a reagent or combination of reagents, wherein a first reagent or combination of reagents in the first test chamber is different than a second reagent or combination of reagents in the second test chamber;
• and
• a fluid pathway comprising a plurality of channels, each defined at least in part by the housing, wherein the fluid pathway includes an inlet, defined at least in part by the housing, through which the test sample is introduced into the device, wherein at least one channel of the plurality of channels is in communication with the inlet and with the first test chamber and the second test chamber to deliver a portion of the test sample to each of the first test chamber and the second test chamber, and wherein the fluid pathway includes an element having a surface defined at least in part by the housing, wherein the element is in communication with a channel of the fluid pathway and from which a pressure gradient when applied from a source external to the device draws the test sample through the fluid pathway and into at least one of the test chambers, wherein the at least one channel of the fluid pathway includes an inlet channel, a first channel, and a second channel, wherein the inlet channel is in communication with the inlet, and wherein the first channel is in communication with the inlet channel and at least with the first test chamber, wherein the second channel is in communication with the inlet channel and at least with the second test chamber;
• wherein the housing includes a thermally conductive wall configured to allow the test sample to be heated, the thermally conductive wall having an outer surface area and an inner surface area,
• wherein the fluid pathway includes a portion at least partially defined by the inner surface area of the thermally conductive wall and the outer surface area of the thermally conductive wall is shaped to be held in at least partially conforming contact with or in close proximity to a heater to allow adjustment of a temperature of the test sample flowing through the portion at least partially defined by the inner surface area of the thermally conductive wall;
• wherein the first reagent or combination of reagents activates the test sample via an intrinsic pathway of coagulation, an extrinsic pathway of coagulation, or a combination thereof;
• wherein the second reagent or combination of reagents activates the test sample via an intrinsic pathway of coagulation, an extrinsic pathway of coagulation, or a combination thereof;
• wherein at least one of the first reagent or combination of reagents and the second reagent or combination of reagents activates the sample via the extrinsic pathway of coagulation;
• wherein the second reagent or combination of reagents further includes an antagonist of fibrinolytic function;
• wherein the first reagent or combination of reagents and the second reagent or combination of reagents are preloaded for a single use in the disposable cartridge;
• wherein the first reagent or combination of reagents interacts with the test sample to be interrogated in the first test chamber to provide a viscoelastic measurement for a determination of one or more clot stiffness values of a clot formed in the first test chamber;
• and
• wherein the second reagent or combination of reagents interacts with the test sample to be interrogated in the second test chamber to provide a viscoelastic measurement for a determination of one or more clot stiffness values of a clot formed in the second test chamber.

A device configured as a disposable cartridge, the device comprising:

• a housing;
• a plurality of test chambers, wherein the plurality of test chambers includes at least a first test chamber and a second test chamber that are each at least partially defined by the housing, wherein the first test chamber and the second test chamber are each designed to receive a test sample of blood and a reagent or combination of reagents, wherein a first reagent or combination of reagents in the first test chamber is different than a second reagent or combination of reagents in the second test chamber;
• and
• a fluid pathway comprising a plurality of channels, each defined at least in part by the housing, wherein the fluid pathway includes an inlet, defined at least in part by the housing, through which the test sample is introduced into the device, wherein at least one channel of the plurality of channels is in communication with the inlet and with the first test chamber and the second test chamber to deliver a portion of the test sample to each of the first test chamber and the second test chamber, wherein the fluid pathway includes an element having a surface defined at least in part by the housing, wherein the element is in communication with a channel of the fluid pathway and from which a pressure gradient when applied from a source external to the device draws the test sample through the fluid pathway and into at least one of the test chambers, wherein the at least one channel of the fluid pathway includes an inlet channel, a first channel, and a second channel, wherein the inlet channel is in communication with the inlet, and wherein the first channel is in communication with the inlet channel and at least with the first test chamber, and wherein the second channel is in communication with the inlet channel and at least with the second test chamber;
• wherein the housing includes a thermally conductive wall configured to allow the test sample to be heated, the thermally conductive wall having an outer surface area and an inner surface area;
• wherein the fluid pathway includes a portion at least partially defined by the inner surface area of the thermally conductive wall and the outer surface area of the thermally conductive wall is shaped to be held in at least partially conforming contact with or in close proximity to a heater to allow adjustment of a temperature of the test sample flowing through the portion at least partially defined by the inner surface area of the thermally conductive wall;
• wherein the first reagent or combination of reagents includes reptilase;
• wherein the second reagent or combination of reagents includes one or both of adenosine diphosphate and arachidonic acid;
• wherein the first reagent or combination of reagents and the second reagent or combination of reagents are each preloaded for a single use in the disposable cartridge;
• wherein the first reagent or combination of reagents interacts with the test sample to be interrogated in the first test chamber that provides a viscoelastic measurement for a determination of one or more clot stiffness values of a clot formed in the first test chamber;
• and
• wherein the second reagent or combination of reagents interacts with the test sample to be interrogated in the second test chamber that provides a viscoelastic measurement for a determination of one or more clot stiffness values of a clot formed in the second test chamber.

A device configured as a disposable cartridge, the device comprising:

• a housing;
• a plurality of test chambers, wherein the plurality of test chambers includes at least a first test chamber, a second test chamber, and a third test chamber that are each at least partially defined by the housing, wherein each of the first test chamber, the second test chamber, and the third test chamber are designed to receive a test sample of blood and a reagent or combination of reagents, wherein a first reagent or combination of reagents, a second reagent or combination of reagents, and a third reagent or combination of reagents each activate the test sample via an intrinsic pathway of coagulation, an extrinsic pathway of coagulation, or a combination thereof, and wherein the first reagent or combination of reagents is different than the second reagent or combination of reagents, and wherein one of the reagent combinations includes an antagonist of fibrinolysis;
• and
• a fluid pathway comprising a plurality of channels, each defined at least in part by the housing;
• wherein the fluid pathway includes an inlet, defined at least in part by the housing, through which the test sample is introduced into the device, wherein at least one channel of the plurality of channels is in communication with the inlet and with the first test chamber, the second test chamber, and the third test chamber to deliver a portion of the test sample to each of the first test chamber, the second test chamber, and the third test chamber, wherein the fluid pathway includes a first port, defined at least in part by the housing, wherein the first port is in communication with a channel of the fluid pathway and from which a pressure gradient when applied from a source external to the device draws the test sample through the fluid pathway and into at least one of the test chambers, wherein the at least one channel of the fluid pathway includes an inlet channel, a first channel, and a second channel, wherein the inlet channel is in communication with the inlet, and wherein the first channel is in communication with the inlet channel and at least with the first test chamber, and wherein the second channel is in communication with the inlet channel and at least with the second test chamber;
• wherein the fluid pathway includes a second port, defined at least in part by the housing, wherein the second port is in communication with a channel of the fluid pathway and from which a pressure gradient when applied from a source external to the device draws the test sample to move from an external vessel through the inlet and the at least one channel of the fluid pathway into the housing;
• wherein the first port and/or the second port prevents the test sample from leaving the device;
• wherein the housing includes a thermally conductive wall configured to allow the test sample to be heated, the thermally conductive wall having an outer surface area and an inner surface area;
• wherein the fluid pathway includes a portion at least partially defined by the inner surface area of the thermally conductive wall and the outer surface area of the thermally conductive wall is shaped to be held in at least partially conforming contact with or in close proximity to a heater to allow adjustment of a temperature of the test sample flowing through the portion at least partially defined by the inner surface area of the thermally conductive wall;
• wherein the first reagent or combination of reagents, the second reagent or combination of reagents, and the third reagent or combination of reagents are each preloaded for a single use in the disposable cartridge;
• and
• wherein the one of the reagent combinations that includes the antagonist of fibrinolysis interacts with the test sample to be interrogated in one of the plurality of test chambers to provide a viscoelastic measurement for a determination of one or more clot stiffness values of a clot formed in the one of the plurality of test chambers associated with the one of the reagent combinations.