Fluid diversion mechanism for bodily-fluid sampling

Abstract

An apparatus includes a housing, a flow control mechanism, and an actuator. At least a portion of the flow control mechanism is movably disposed within the housing. The apparatus further includes an inlet port and an outlet port, and defines a fluid reservoir. The outlet port is fluidically coupled to a second fluid reservoir and is fluidically isolated from the first fluid reservoir. The actuator is configured to move the flow control mechanism between a first configuration, in which the inlet port is placed in fluid communication with the fluid reservoir such that the fluid reservoir receives a first flow of bodily-fluid, and a second configuration, in which the inlet port is placed in fluid communication with the outlet port.

1 - 30 . (canceled) 
     
     
         31 . A blood sampling system, comprising:
 a blood sampling pathway having a lumen-containing device coupleable to a patient on a distal end and a sample needle on a proximal end; and   a blood transfer device attached on the blood sampling pathway between the proximal end and the distal end of the blood sampling pathway, the blood transfer device comprising:
 an inlet port coupled with the blood sampling pathway toward the patient; 
 an outlet port coupled with the blood sampling pathway toward the sample needle; 
 a reservoir in fluid communication with the inlet port, the reservoir having a vent allowing air to exit the blood transfer device as blood enters the reservoir; and 
 a sampling flow path having a distal end in fluid communication with the outlet port and a proximal end in fluid communication with the sample needle. 
   
     
     
         32 . The blood sampling system of  claim 31 , wherein the blood transfer device allows a first portion of blood to flow into the reservoir. 
     
     
         33 . The blood sampling system of  claim 32 , wherein the blood transfer device allows a second portion of blood to bypass the reservoir and flow toward the outlet port. 
     
     
         34 . The blood sampling system of  claim 33 , wherein the blood transfer device allows the second portion of blood to flow toward the outlet port in response to the first portion of blood being received in the reservoir. 
     
     
         35 . The blood sampling system of  claim 31 , wherein the blood transfer device has a first state in which a first portion of blood flows into the reservoir toward the vent and a second state in which the first portion of blood is sequestered in the reservoir and a second portion of blood flows through the blood sampling pathway while bypassing the reservoir. 
     
     
         36 . The blood sampling system of  claim 31 , wherein the blood transfer device further comprises:
 a seal member defining at least a portion of the reservoir, the blood transfer device having a first state in which the seal member allows blood to flow into the reservoir toward the seal member and air to flow out of the vent away from the seal member, the blood transfer device having a second state in which the seal member separates the blood in the reservoir from air outside the reservoir.   
     
     
         37 . The blood sampling system of  claim 31 , wherein the blood sampling pathway includes:
 a first sterile tubing having a distal end coupleable to the lumen-containing device and a proximal end coupleable to the inlet port of the blood transfer device; and   a second sterile tubing having a distal end coupleable to the outlet port of the blood transfer device and a proximal end coupleable to the sample needle.   
     
     
         38 . The blood sampling system of  claim 37 , wherein the blood transfer device automatically transitions from a first state to a second state in response to a first portion of blood being received in the reservoir, the sampling flow path allowing fluid communication between the first sterile tubing and the second sterile tubing when the blood transfer device is in the second state such that a second portion of blood flows from the lumen-containing device to the sample needle while bypassing the reservoir. 
     
     
         39 . A blood sampling system, comprising:
 a blood sampling pathway having a lumen-containing device coupleable to a patient on a distal end and a sample needle on a proximal end; and   a blood transfer device attached on the blood sampling pathway between the proximal end and the distal end of the blood sampling pathway, the blood transfer device comprising:
 an inlet port coupled with the blood sampling pathway toward the patient; 
 an outlet port coupled with the blood sampling pathway toward the sample needle; 
 a fluid reservoir in fluid communication with the inlet port, the fluid reservoir at least partially defined by a seal member, the seal member allowing blood to flow from the patient into the fluid reservoir and toward the seal member when the seal member transitions from a first state to a second state; and 
 a sampling flow path having a distal end in fluid communication with the outlet port and a proximal end in fluid communication with the sample needle. 
   
     
     
         40 . The blood sampling system of  claim 39 , wherein the blood transfer device defines an inner volume, at least a portion of the inner volume defining the reservoir, the blood transfer device further comprising:
 a vent allowing air to exit the inner volume as blood enters the reservoir.   
     
     
         41 . The blood sampling system of  claim 40 , wherein the seal member is configured to prevent the flow of air through the vent into the reservoir. 
     
     
         42 . The blood sampling system of  claim 40 , wherein the blood transfer device has a first configuration in which the seal member allows blood to flow into the reservoir toward the seal member and air to flow out of the vent away from the seal member, the blood transfer device has a second configuration in which the seal member separates the blood in the reservoir from air outside the reservoir. 
     
     
         43 . The blood sampling system of  claim 39 , wherein the seal member allows a first portion of blood to flow into the reservoir toward the seal member and the sampling flow path allows a second portion of blood to flow toward the outlet port in response to the first portion of blood being received in the reservoir. 
     
     
         44 . The blood sampling system of  claim 39 , wherein the blood transfer device has a first configuration in which a first portion of blood flows into the reservoir toward the seal member and a second configuration in which the first portion of blood is sequestered in the reservoir and a second portion of blood flows through the blood sampling pathway while bypassing the reservoir. 
     
     
         45 . The blood sampling system of  claim 39 , wherein the blood sampling pathway includes:
 a first sterile tubing having a distal end coupleable to the lumen-containing device and a proximal end coupleable to the inlet port of the blood transfer device; and   a second sterile tubing having a distal end coupleable to the outlet port of the blood transfer device and a proximal end coupleable to the sample needle.   
     
     
         46 . The blood sampling system of  claim 45 , wherein the blood transfer device automatically transitions from a first configuration to a second configuration in response to a first portion of blood being received in the reservoir, the sampling flow path allowing fluid communication between the first sterile tubing and the second sterile tubing when the blood transfer device is in the second state such that a second portion of blood flows from the lumen-containing device to the sample needle while bypassing the reservoir.