Fluid control devices and methods of using the same

Abstract

A fluid control device includes an inlet configured to be placed in fluid communication with a bodily fluid source and an outlet configured to be placed in fluid communication with a fluid collection device, which can produce a negative pressure differential between the outlet and the inlet. A sequestration portion is in fluid communication with the inlet and includes a first flow controller configured to transition from a first state to a second state to place the sequestration portion in fluid communication with the outlet when the negative pressure differential has a first magnitude. A sampling portion is in fluid communication with an outlet and includes a second flow controller configured to transition from a first state to a second state to place the sampling portion in fluid communication with the inlet when the negative pressure differential has a second magnitude greater than the first magnitude.

1 .- 27 . (canceled) 
     
     
         28 . A fluid control device, the device comprising:
 an inlet fluidically coupleable to a bodily fluid source;   an outlet fluidically coupleable to a fluid collection device;   a first flow controller disposed in a containment channel, the first flow controller in a first state allowing a flow of gas but not bodily fluid through the containment channel and to the outlet, a negative pressure differential between the inlet and the outlet generated by fluidically coupling the outlet to the fluid collection device being operable to draw an initial volume of bodily fluid from the inlet to the containment channel when the first flow controller is in the first state, the first flow controller in a second state preventing flow of the initial volume to the outlet; and   a second flow controller in fluid communication with a sampling channel, the second flow controller in a first state preventing fluid flow from the inlet and into the sampling channel, the second flow controller transitioning to a second state when a magnitude of the negative pressure differential within the sampling channel exceeds a threshold pressure differential, the second flow controller in the second state allowing bodily fluid to flow from the inlet through the sampling channel to the outlet.   
     
     
         29 . The device of  claim 28 , wherein the fluid collection device is a sample bottle that is at least partially evacuated, the outlet being fluidically coupled to the sample bottle generating the negative pressure differential. 
     
     
         30 . The device of  claim 28 , wherein the fluid collection device is a syringe that is manipulated after the outlet is fluidically coupled to the syringe to generate the negative pressure differential. 
     
     
         31 . The device of  claim 28 , wherein the first flow controller includes a selectively permeable material, the initial volume of bodily fluid in the containment portion saturating the selectively permeable material to transition the first flow controller from the first state to the second state. 
     
     
         32 . The device of  claim 28 , wherein the first flow controller in the first state allows a magnitude of the negative pressure differential to remain below the threshold pressure differential. 
     
     
         33 . The device of  claim 28 , wherein the first flow controller in the second state allows the negative pressure differential to build in the sampling portion to a magnitude greater than the threshold pressure differential. 
     
     
         34 . The device of  claim 33 , wherein the second flow controller is a displaceable barrier, the first state of the second flow controller corresponding to the displaceable barrier being in a first position, the second state of the second flow controller corresponding to the displaceable barrier being in a second position different from the first position, the magnitude of the negative pressure differential when the first flow controller is in the second state moves the displaceable barrier from the first position to the second position. 
     
     
         35 . The device of  claim 28 , wherein the bodily fluid allowed to flow from the inlet through the sampling channel to the outlet has reduced contamination due to the containment reservoir receiving the initial volume of bodily fluid and potential contaminants therein. 
     
     
         36 . The device of  claim 28 , wherein the first flow controller is configured to transition from the first state to the second state automatically. 
     
     
         37 . The device of  claim 28 , wherein the second flow controller is configured to transition from the first state to the second state automatically. 
     
     
         38 . A fluid control device, the device comprising:
 a housing having an inlet fluidically coupleable to a bodily fluid source and an outlet fluidically coupleable to a fluid collection device, the housing defining a containment channel in fluid communication with the inlet and a sampling channel in fluid communication with the outlet;   a first flow controller disposed in the housing, the first flow controller in a first state allowing gas flow between the containment channel and the outlet, the first flow controller in a second state preventing fluid flow from the containment channel to the outlet; and   a second flow controller disposed in the housing, the second flow controller in a first state preventing fluid flow between the inlet and the sampling channel, the second flow controller in a second state allowing bodily fluid to flow from the inlet through the sampling channel to the outlet,   a negative pressure differential within at least one of the containment channel or the sampling channel generated by coupling the outlet to the fluid collection device having a first magnitude below a threshold pressure differential while the first flow controller is in the first state, the negative pressure differential building in at least a portion of the sampling channel to a second magnitude greater than the threshold pressure differential when the first flow controller is in the second state, the second flow controller operable to transition from the first state to the second state in response to the negative pressure differential having the second magnitude.   
     
     
         39 . The device of  claim 38 , wherein the fluid collection device is a sample bottle that is at least partially evacuated, the outlet being fluidically coupled to the sample bottle generating the negative pressure differential. 
     
     
         40 . The device of  claim 38 , wherein the fluid collection device is a syringe that is manipulated after the outlet is fluidically coupled to the syringe to generate the negative pressure differential. 
     
     
         41 . The device of  claim 38 , wherein the first flow controller is configured to transition from the first state to the second state automatically. 
     
     
         42 . The device of  claim 38 , wherein the second flow controller is configured to transition from the first state to the second state automatically. 
     
     
         43 . The device of  claim 38 , wherein the first flow controller includes a selectively permeable material that allows gas flow and prevents bodily fluid flow through the first flow controller when the flow controller is in the first state and that prevents both gas flow and bodily fluid flow through the first flow controller when the flow controller is in the second state. 
     
     
         44 . The device of  claim 43 , wherein the first flow controller in the first state allows an initial volume of bodily fluid to flow from the inlet to the containment channel, the first flow controller is transitioned from the first state to the second state when the initial volume of bodily fluid in the containment channel saturates the selectively permeable material. 
     
     
         45 . The device of  claim 44 , wherein the bodily fluid allowed to flow from the inlet through the sampling channel to the outlet has reduced contamination due to the containment channel receiving the initial volume of bodily fluid and potential contaminants therein. 
     
     
         46 . The device of  claim 38 , wherein the second flow controller is a displaceable barrier, the first state of the second flow controller corresponding to the displaceable barrier being in a first position, the second state of the second flow controller corresponding to the displaceable barrier being in a second position different from the first position, the displaceable barrier being moved from the first position to the second position in response to the negative pressure differential having the second magnitude.