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 method of using a blood sequestration device to obtain a blood sample from a patient with reduced contamination, the blood sequestration device having a housing and a fluid reservoir disposed in the housing, the method comprising:
 establishing fluid communication between an inlet port of the housing and the patient;   receiving an initial volume of blood withdrawn from the patient into the fluid reservoir, the fluid reservoir at least partially defined by a seal member;   allowing air to exit the housing via a vent as blood enters the fluid reservoir;   sequestering the initial volume of blood in the fluid reservoir; and   transferring a subsequent volume of blood from the inlet port toward an outlet port of the housing via a sampling flow path, thereby bypassing the fluid reservoir and the initial volume of blood sequestered therein.   
     
     
         32 . The method of  claim 31 , wherein the initial volume of blood is less than approximately 5 ml. 
     
     
         33 . The method of  claim 31 , wherein the initial volume of blood is less than approximately 0.5 ml. 
     
     
         34 . The method of  claim 31 , wherein the initial volume of blood is approximately 0.1 ml to approximately 0.5 ml. 
     
     
         35 . The method of  claim 31 , wherein the outlet port is fluidically isolated from the fluid reservoir. 
     
     
         36 . The method of  claim 31 , wherein the seal member is configured to inhibit air from reentering the fluid reservoir through the vent. 
     
     
         37 . The method of  claim 31 , wherein the initial volume of blood is fluidically isolated in the fluid reservoir. 
     
     
         38 . The method of  claim 31 , wherein the blood sequestration device is in a first operating mode during the receiving of the initial volume of blood, the method further comprising:
 automatically transitioning the blood sequestration device from the first operating mode to a second operating mode to allow the sequestering of the initial volume of blood in the fluid reservoir and the transferring of the subsequent volume of blood from the inlet port toward the outlet port.   
     
     
         39 . A method of using a blood sequestration device to obtain a blood sample from a patient with reduced contamination, the blood sequestration device having a housing and a fluid reservoir defined at least partially by the housing, the method comprising:
 establishing fluid communication between an inlet port of the housing and the patient;   in a first operating mode, allowing an initial volume of blood received from the patient to flow into the fluid reservoir via a first fluid flow path disposed in the housing;   allowing air to exit the housing via a vent as blood enters the fluid reservoir;   sequestering the initial volume of blood in the fluid reservoir; and   in a second operating mode, allowing a subsequent volume of blood to flow from the inlet port toward an outlet port of the housing via a second fluid flow path disposed in the housing, thereby bypassing the fluid reservoir and the initial volume of blood sequestered therein.   
     
     
         40 . The method of  claim 39 , wherein the initial volume of blood is less than approximately 5 ml. 
     
     
         41 . The method of  claim 39 , wherein the initial volume of blood is less than approximately 0.5 ml. 
     
     
         42 . The method of  claim 39 , wherein the initial volume of blood is approximately 0.1 ml to approximately 0.5 ml. 
     
     
         43 . The method of  claim 39 , wherein the outlet port is fluidically isolated from the fluid reservoir. 
     
     
         44 . The method of  claim 39 , wherein the initial volume of blood is fluidically isolated in the fluid reservoir. 
     
     
         45 . The method of  claim 39 , wherein the fluid reservoir is at least partially defined by a seal member disposed in the housing. 
     
     
         46 . The method of  claim 39 , wherein the fluid reservoir is at least partially defined by a seal member disposed in the housing, the seal member configured to inhibit air from reentering the fluid reservoir through the vent. 
     
     
         47 . The method of  claim 39 , wherein the blood sequestration device transitions from the first operating mode to the second operating mode without manual intervention. 
     
     
         48 . A method of using a blood sequestration device to obtain a blood sample from a patient with reduced contamination, the blood sequestration device having a housing and a fluid reservoir at least partially defined by the housing, the method comprising:
 establishing fluid communication between the housing and the patient via a lumen-containing device;   in a first state, allowing an initial volume of blood to flow from the patient toward a seal member defining a portion of the fluid reservoir;   allowing air to exit the housing via a vent as blood enters the fluid reservoir;   sequestering the initial volume of blood in the fluid reservoir; and   in a second state, allowing a subsequent volume of blood to flow from the inlet port toward an outlet port of the housing, thereby bypassing the fluid reservoir and the initial volume of blood sequestered therein.   
     
     
         49 . The method of  claim 48 , wherein the initial volume of blood is less than approximately 5 ml. 
     
     
         50 . The method of  claim 48 , wherein the initial volume of blood is less than approximately 0.5 ml. 
     
     
         51 . The method of  claim 48 , wherein the initial volume of blood is approximately 0.1 ml to approximately 0.5 ml. 
     
     
         52 . The method of  claim 48 , wherein the seal member is configured to inhibit air from reentering the fluid reservoir through the vent. 
     
     
         53 . The method of  claim 48 , wherein the initial volume of blood is fluidically isolated in the fluid reservoir. 
     
     
         54 . The method of  claim 48 , further comprising:
 establishing fluid communication between the outlet port and a sample reservoir.   
     
     
         55 . A method of using a blood sequestration device to obtain a blood sample from a patient with reduced contamination, the blood sequestration device defines a first fluid flow path and a second fluid flow path, the method comprising:
 establishing fluid communication between the blood sequestration device and the patient via a lumen-containing device;   allowing an initial volume of blood to flow from the patient toward a seal member via the first fluid flow path when in a first operating mode;   allowing air to exit the blood sequestration device via a vent as blood enters the first fluid flow path;   transitioning the seal member from a first state to a second state, thereby placing the blood sequestration device in a second operating mode; and   allowing a subsequent volume of blood to flow from the patient toward an outlet port of the blood sequestration device via the second fluid flow path when in the second operating mode, thereby bypassing the initial volume of blood sequestered in the first fluid flow path.   
     
     
         56 . The method of  claim 55 , wherein the initial volume of blood is less than approximately 5 ml. 
     
     
         57 . The method of  claim 55 , wherein the initial volume of blood is less than approximately 0.5 ml. 
     
     
         58 . The method of  claim 55 , wherein the initial volume of blood is approximately 0.1 ml to approximately 0.5 ml. 
     
     
         59 . The method of  claim 55 , wherein the initial volume of blood is fluidically isolated in the first fluid flow path. 
     
     
         60 . The method of  claim 55 , further comprising:
 establishing fluid communication between the outlet port and a sample reservoir.