Blood sample optimization system and blood contaminant sequestration device and method

Abstract

Blood sample optimization systems and methods are described that reduce or eliminate contaminates in collected blood samples, which in turn reduces or eliminates false positive readings in blood cultures or other testing of collected blood samples. A blood sample optimization system can include a blood sequestration device located between a patient needle and a sample needle. The blood sequestration device can include a sequestration chamber for sequestering an initial, potentially contaminated aliquot of blood, and may further include a sampling channel that bypasses the sequestration chamber to convey likely uncontaminated blood between the patient needle and the sample needle after the initial aliquot of blood is sequestered in the sequestration chamber.

1 . A bodily fluid sample optimization device for optimizing a bodily fluid sample collected by a bodily fluid collection device from a bodily fluid source, a first portion of the bodily fluid sample potentially having contaminants, the bodily fluid sample optimization device comprising:
 an inlet configured to connect with the bodily fluid source;   an outlet configured to connect with the bodily fluid collection device;   a sample path between the inlet and the outlet; and   a contaminant containment reservoir between the inlet and the outlet, the contaminant containment reservoir having an air permeable bodily fluid resistor proximate the outlet, the contaminant containment reservoir being arranged to receive, when a pressure differential is applied between the inlet and the outlet, a first portion of the bodily fluid sample from the bodily fluid source via the inlet to displace air in the contaminant containment reservoir through the air permeable bodily fluid resistor and the outlet, such that upon receipt of the first portion of the bodily fluid sample and containment of the contaminants in the contaminant containment reservoir, subsequent portions of the bodily fluid sample can be conveyed by the sample path from the inlet to the outlet and to the bodily fluid collection device.   
     
     
         2 . The bodily fluid sample optimization device in accordance with  claim 1 , further including a housing that defines the inlet and the outlet, and contains the sample path and the contaminant containment reservoir, and wherein the housing does not vent to atmosphere when the outlet is connected with the bodily fluid collection device. 
     
     
         3 . The bodily fluid sample optimization device in accordance with  claim 1 , wherein the pressure differential applied between the inlet and the outlet is applied by a vacuum of the bodily fluid collection device relative to a pressure of the bodily fluid source. 
     
     
         4 . The bodily fluid sample optimization device in accordance with  claim 1 , wherein the connection between the sample path and the inlet is made when the contaminant containment reservoir receives the first portion of the bodily fluid sample. 
     
     
         5 . The bodily fluid sample optimization device in accordance with  claim 1 , wherein once the first portion is received in the contaminant containment reservoir, a resistance to a flow of the subsequent portions of the bodily fluid sample in the contaminant containment reservoir is higher than a resistance in the sample path. 
     
     
         6 . The bodily fluid sample optimization device in accordance with  claim 4 , wherein the contaminant containment reservoir includes a flow controller that is movable from a first position to enable the contaminant containment reservoir to receive, when the pressure differential is applied between the inlet and the outlet, the first portion of the bodily fluid sample from the bodily fluid source via the inlet, to a second position to open the connection between the sample path and the inlet to allow the subsequent portions of the bodily fluid sample to be conveyed by the sample path from the inlet to the outlet and to the bodily fluid collection device. 
     
     
         7 . The bodily fluid sample optimization device in accordance with  claim 6 , wherein movement of the flow controller exposes at least one aperture between the inlet and the sample path. 
     
     
         8 . The bodily fluid sample optimization device in accordance with  claim 6 , wherein the flow controller is movable by the pressure differential. 
     
     
         9 . A bodily fluid control device comprising:
 an inlet fluidically coupleable to a bodily fluid source;   an outlet fluidically coupleable to a bodily fluid sample collection device, and to allow a negative pressure differential between the outlet and the inlet when the outlet is fluidically coupled to the bodily fluid sample collection device;   a sampling channel between the inlet and the outlet;   a containment chamber between the inlet and the outlet, the containment chamber having a first flow controller that allows air to flow from the containment chamber to the outlet by the negative pressure differential between the outlet and the inlet, such that a first volume of bodily fluid is drawn from the inlet into the containment chamber, and to prevent the first volume of bodily fluid from flowing to the outlet; and   a second flow controller that is movable from a first position as the first volume of bodily fluid is drawn from the inlet into the containment chamber, to a second position to allow subsequent volumes of bodily fluid from the inlet to bypass the containment chamber via the sampling channel and to the outlet and the bodily fluid sample collection device.   
     
     
         10 . The bodily fluid control device in accordance with  claim 9 , wherein the bodily fluid source includes a patient needle. 
     
     
         11 . The bodily fluid control device in accordance with  claim 9 , wherein the bodily fluid sample collection device includes a sealed collection needle. 
     
     
         12 . The bodily fluid control device in accordance with  claim 9 , wherein the first flow controller includes an air permeable blood barrier that seals upon contact with bodily fluid. 
     
     
         13 . The bodily fluid control device in accordance with  claim 9 , wherein the second flow controller is movable from the first position to the second position by the pressure differential. 
     
     
         14 . The bodily fluid control device in accordance with  claim 9 , further including a housing that defines the inlet and the outlet, and wherein the housing contains the containment chamber and the sampling channel. 
     
     
         15 . The bodily fluid control device in accordance with  claim 14 , wherein the housing does not vent to atmosphere when the inlet is fluidically coupleable to the bodily fluid source and the outlet is fluidically coupled to the bodily fluid sample collection device. 
     
     
         15 . The bodily fluid control device in accordance with  claim 9 , wherein the negative pressure differential applied between the inlet and the outlet is applied by a vacuum of the bodily fluid sample collection device relative to a pressure of the bodily fluid source. 
     
     
         16 . The bodily fluid control device in accordance with  claim 9 , wherein a fluidic coupling between the sample path and the inlet is made only after the containment chamber receives the first volume of the bodily fluid. 
     
     
         17 . The bodily fluid control device in accordance with  claim 1 , wherein once the first portion is received in the containment chamber, a resistance to a flow of the subsequent volumes of the bodily fluid in the containment chamber is higher than a resistance in the sampling channel. 
     
     
         18 . A patient bodily fluid sample optimization system comprising:
 a bodily fluid source comprising a venipuncture device configured for venipuncture of the patient;   a bodily fluid collection device comprising a sealed collection needle on which an evacuated tube can be placed to draw the patient bodily fluid with a pressure differential between the evacuated tube and the patient; and   a bodily fluid sample optimization device comprising:
 an inlet configured to connect with the bodily fluid source; 
 an outlet configured to connect with the bodily fluid collection device; 
 a sample path between the inlet and the outlet; and 
 a contaminant containment reservoir between the inlet and the outlet, the contaminant containment reservoir having an air permeable bodily fluid resistor proximate the outlet, the contaminant containment reservoir being arranged to receive, when the pressure differential is formed between the inlet and the outlet, a first portion of the bodily fluid sample from the bodily fluid source via the inlet to displace air in the contaminant containment reservoir through the air permeable bodily fluid resistor and the outlet, such that upon receipt of the first portion of the bodily fluid sample and containment of the contaminants in the contaminant containment reservoir, subsequent portions of the bodily fluid sample can be conveyed by the sample path from the inlet to the outlet and to the bodily fluid collection device. 
   
     
     
         19 . The patient bodily fluid sample optimization system in accordance with  claim 18 , further including a housing that defines the inlet and the outlet, and contains the sample path and the contaminant containment reservoir, and wherein the housing does not vent to atmosphere when the outlet is connected with the bodily fluid collection device. 
     
     
         20 . The patient bodily fluid sample optimization system in accordance with  claim 18 , wherein the pressure differential applied between the inlet and the outlet is applied by a vacuum of the bodily fluid collection device relative to a pressure of the bodily fluid source. 
     
     
         21 . The patient bodily fluid sample optimization system in accordance with  claim 18 , wherein the connection between the sample path and the inlet is made when the contaminant containment reservoir receives the first portion of the bodily fluid sample. 
     
     
         22 . The patient bodily fluid sample optimization system in accordance with  claim 18 , wherein once the first portion is received in the contaminant containment reservoir, a resistance to a flow of the subsequent portions of the bodily fluid sample in the contaminant containment reservoir is higher than a resistance in the sample path. 
     
     
         23 . The patient bodily fluid sample optimization system in accordance with  claim 22  wherein the contaminant containment reservoir includes a flow controller that is movable from a first position to enable the contaminant containment reservoir to receive, when the pressure differential is applied between the inlet and the outlet, the first portion of the bodily fluid sample from the bodily fluid source via the inlet, to a second position to open the connection between the sample path and the inlet to allow the subsequent portions of the bodily fluid sample to be conveyed by the sample path from the inlet to the outlet and to the bodily fluid collection device. 
     
     
         24 . The patient bodily fluid sample optimization system in accordance with  claim 23 , wherein movement of the flow controller exposes at least one aperture between the inlet and the sample path. 
     
     
         25 . The patient bodily fluid sample optimization system in accordance with  claim 23 , wherein the flow controller is movable by the pressure differential. 
     
     
         26 . A patient bodily fluid control system comprising:
 a bodily fluid source comprising venipuncture device for venipuncture to the patient;   a bodily fluid sample collection device comprising a sealed collection needle on which an evacuated tube can be placed to draw the patient bodily fluid with a negative pressure differential between the evacuated tube and the patient; and   a bodily fluid control device comprising:
 an inlet fluidically coupleable to the bodily fluid source; 
 an outlet fluidically coupleable to a bodily fluid sample collection device, and to allow a negative pressure differential between the outlet and the inlet when the outlet is fluidically coupled to the bodily fluid sample collection device; 
 a sampling channel between the inlet and the outlet; 
 a containment chamber between the inlet and the outlet, the containment chamber having a first flow controller that allows air to flow from the containment chamber to the outlet by the negative pressure differential between the outlet and the inlet, such that a first volume of bodily fluid is drawn from the inlet into the containment chamber, and to prevent the first volume of bodily fluid from flowing to the outlet; and 
 a second flow controller that is movable from a first position as the first volume of bodily fluid is drawn from the inlet into the containment chamber, to a second position to allow subsequent volumes of bodily fluid from the inlet to bypass the containment chamber via the sampling channel and to the outlet and the bodily fluid sample collection device. 
   
     
     
         27 . The bodily fluid control system in accordance with  claim 26 , wherein the first flow controller includes an air permeable blood barrier that seals upon contact with bodily fluid. 
     
     
         28 . The bodily fluid control system in accordance with  claim 26 , wherein the second flow controller is movable from the first position to the second position by the pressure differential. 
     
     
         29 . The bodily fluid control system in accordance with  claim 26 , further including a housing that defines the inlet and the outlet, and wherein the housing contains the containment chamber and the sampling channel. 
     
     
         30 . The bodily fluid control system in accordance with  claim 29 , wherein the housing does not vent to atmosphere when the inlet is fluidically coupleable to the bodily fluid source and the outlet is fluidically coupled to the bodily fluid sample collection device.