Systems and Methods of Sample Processing and Fluid Control in a Fluidic System

Abstract

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

What is claimed is: 
     
         1 . A cartridge configured to perform an assay, comprising:
 a sample collection unit configured to receive a biological fluid sample;   a metering channel configured to meter a volume of the biological fluid sample;   a mixing chamber configured to be brought into fluidic communication with the metering channel and to receive a portion of the biological fluid sample;   a reagent chamber having a volume of less than 100 microliters and including a dried reagent to be liquefied upon initiation of the assay, the reagent chamber being configured to be brought into fluid communication with the mixing chamber; and   a plurality of reaction sites in fluid communication with the reagent chamber, each reaction site comprising a reactant bound thereto and configured to generate an optical signal in response to reacting with an analyte present in the biological fluid sample.   
     
     
         2 . The cartridge of  claim 1 , wherein the optical signals generated are detectable by a charge coupled device. 
     
     
         3 . The cartridge of  claim 1 , wherein the optical signals generated are fluorescent signals. 
     
     
         4 . The cartridge of  claim 1 , further comprising a fluidic channel connecting the mixing chamber and the reagent chamber. 
     
     
         5 . The cartridge of  claim 4 , wherein the fluidic channel further comprises a burstable seal. 
     
     
         6 . The cartridge of  claim 1 , further comprising a fluidic channel connecting the reagent chamber with the plurality of reaction sites. 
     
     
         7 . The cartridge of  claim 6 , wherein the fluidic channel further comprises a burstable seal. 
     
     
         8 . The cartridge of  claim 1 , further comprising:
 a dilution chamber configured to receive a diluent and being configured to be brought into and out of fluidic communication with the metering channel.   
     
     
         9 . The cartridge of  claim 1 , wherein the mixing chamber comprises a lysing assembly configured to lyse cells present in the bodily fluid sample. 
     
     
         10 . The cartridge of  claim 9 , wherein the mixing chamber is configured to receive a diluent from a dilution chamber and receive a portion of the biological fluid sample. 
     
     
         11 . The cartridge of  claim 10 , the mixing chamber comprising a movable mixing element configured to cause the mixing of the portion of the biological fluid sample with the diluent. 
     
     
         12 . The cartridge of  claim 1 , the mixing chamber comprising a movable mixing element configured to mechanically mix the sample. 
     
     
         13 . The cartridge of  claim 12 , wherein the movable mixing element is magnetically controlled. 
     
     
         14 . A system configured to detect an optical signal indicating the presence of an analyte in a bodily fluid sample, comprising:
 a cartridge configured to perform an assay, comprising:   a sample collection unit capable of receiving the bodily fluid sample;   a metering channel configured to meter a volume of the bodily fluid sample;   a mixing chamber configured to be brought into fluidic communication with the metering channel and to receive a portion of the bodily fluid sample to be mixed;   a reagent chamber having a volume of less than 100 microliters and including a dried reagent to be liquefied upon initiation of the assay, the reagent chamber being configured to be brought into fluid communication with the mixing chamber; and   a plurality of reaction sites in fluid communication with the reagent chamber, each reaction site comprising a reactant bound thereto and configured to generate an optical signal in response to reacting with the analyte present in the bodily fluid sample; and   a reader assembly configured to receive the cartridge and configured to detect the optical signals; and   a communication assembly for transmitting said an indication that the optical signals were detected to an external device.   
     
     
         15 . The system of  claim 14 , wherein the cartridge is configured to run a specific assay based on an assay protocol transmitted to the reader assembly from the external device, wherein a first reaction site of the plurality of reaction sites comprises a first reactant, and wherein a second reaction site of the plurality of reaction sites comprises a second reactant different from the first reactant. 
     
     
         16 . The system of  claim 15 , wherein the assay protocol is transmitted via a wired connection from the external device. 
     
     
         17 . The system of  claim 14 , wherein the cartridge further comprising an identifier readable by the reader assembly and configured to provide the identity of the cartridge. 
     
     
         18 . The system of  claim 17 , wherein the assay protocol varies depending on the identifier. 
     
     
         19 . The system of  claim 14 , wherein said system is configured to monitor more than one pharmacological parameter. 
     
     
         20 . The system of  claim 14 , the reader assembly further comprising a charge coupled device configured to detect the optical signal.