Blood testing system and method

Abstract

Some embodiments of a blood coagulation testing system include an analyzer console device and a single-use cartridge component configured to releasably install into the console device. In some embodiments, the blood coagulation testing system can operate as an automated thromboelastometry system that is particularly useful, for example, at a point-of-care site.

1 - 37 . (canceled) 
     
     
         38 . A cartridge for use with a testing console, the cartridge comprising:
 a plurality of sample processing and testing paths arranged in a parallel, each sample processing and testing path comprising:
 a test sample volume measurement chamber having an internal volume to contain a predefined amount of a test sample; 
 a reagent chamber in fluid communication with the test sample volume measurement chamber and with a reagent, the reagent chamber being configured to receive liquid based on the predefined amount of the test sample for mixing with the reagent to produce a mixture based on the test sample and the reagent; 
 a viscoelastic testing chamber configured to receive the mixture and to enable a viscoelastic test to be performed on the mixture while the mixture resides in the testing chamber; and 
 conduits creating fluidic connections among the test sample volume measurement chamber, the reagent chamber, and the viscoelastic testing chamber, each conduit having a different three-dimensional structure than each of the test sample volume measurement chamber, the reagent chamber, and the viscoelastic testing chamber; and 
   a vent port in fluid communication with atmospheric pressure and a test sample volume measurement chamber of the plurality of sample processing and testing paths, the vent port being configured to be closed to enable filling of the test sample volume measurement chambers with respective predefined amounts of the test sample and to prevent test sample from reaching a reagent chamber.   
     
     
         39 . The cartridge of  claim 38 , wherein the reagent chamber contains reagent beads in solid form that dissolve when contacted with test sample. 
     
     
         40 . The cartridge of  claim 39 , wherein the reagent beads comprise reagent compositions comprising one or more of CaCl 2 , ellagic acid/phospholipids, tissue factor, heparinase, polybrene, cytochalasin D, or tranexamic acid. 
     
     
         41 . The cartridge of  claim 38 , wherein each of the sample processing and testing paths comprises a structure associated with a corresponding conduit, each structure being controllable to prevent fluid flow. 
     
     
         42 . The cartridge of  claim 41 , wherein the structure is a valve. 
     
     
         43 . The cartridge of  claim 38 , wherein the reagent chamber is a first reagent chamber and the reagent is a first reagent;
 wherein the cartridge comprises a second reagent chamber in series with the first reagent chamber, the second reagent chamber being in fluid communication with the test sample volume measurement chamber and with a second reagent; and   wherein the mixture is based on both the first reagent and the second reagent.   
     
     
         44 . The cartridge of  claim 43 , wherein the first reagent and the second reagent comprise different reagents. 
     
     
         45 . The cartridge of  claim 38 , wherein each of the sample processing and testing paths comprises a conduit of the conduits for transporting the mixture to a corresponding viscoelastic testing chamber, the conduit being non-linear. 
     
     
         46 . The cartridge of  claim 38 , further comprising:
 an elastomer associated with each of the processing and testing paths.   
     
     
         47 . The cartridge of  claim 38 , further comprising:
 alignment structures configured to align the cartridge with the testing console, the alignment structures being different from the plurality of sample processing and testing paths.   
     
     
         48 . The cartridge of  claim 47 , wherein the alignment structures comprise two alignment holes. 
     
     
         49 . The cartridge of  claim 47 , wherein at least part each of four of the plurality of sample processing and testing paths is between the alignment structures. 
     
     
         50 . The cartridge of  claim 47 , wherein the reagent chamber comprises reagent beads in solid form that dissolve when contacted with test sample. 
     
     
         51 . The cartridge of  claim 50 , wherein the reagent beads comprise reagent compositions comprising one or more of CaCl 2 , ellagic acid/phospholipids, tissue factor, heparinase, polybrene, cytochalasin D, or tranexamic acid. 
     
     
         52 . The cartridge of  claim 47 , wherein the reagent chamber is a first reagent chamber and the reagent is a first reagent;
 wherein the cartridge comprises a second reagent chamber in series with the first reagent chamber, the second reagent chamber being in fluid communication with the test sample volume measurement chamber and with a second reagent; and   wherein the mixture is based on both the first reagent and the second reagent.   
     
     
         53 . The cartridge of  claim 52 , wherein the first reagent and the second reagent comprise different reagents. 
     
     
         54 . The cartridge of  claim 53 , wherein each of the sample processing and testing paths comprises a structure associated with a corresponding conduit, each structure being controllable to prevent fluid flow. 
     
     
         55 . The cartridge of  claim 54 , wherein e structure is a valve. 
     
     
         56 . The cartridge of  claim 52 , wherein each of the sample processing and testing paths comprises a conduit of the conduits for transporting the mixture to a corresponding viscoelastic testing chamber, the conduit being non-linear. 
     
     
         57 . The cartridge of  claim 56 , further comprising:
 an elastomer associated with each of the sample processing and testing paths.