Devices and methods for syringe-based fluid transfer for bodily-fluid sampling

Abstract

An apparatus includes a housing, defining an inner volume, and an actuator mechanism movably disposed therein. The actuator mechanism is configured to be transitioned from a first configuration to a second configuration to define a pre-sample reservoir fluidically couplable to receive a pre-sample volume of bodily-fluid via an inlet port of the housing. The actuator mechanism is movable from a first position to a second position within the housing after the pre-sample reservoir receives the pre-sample volume such that the housing and the actuator mechanism collectively define a sample reservoir to receive a sample volume of bodily-fluid via the inlet port. The outlet port is in fluid communication with the sample reservoir and is configured to be fluidically coupled to an external fluid reservoir after the sample volume is disposed in the sample reservoir to transfer at least a portion of the sample volume into the external fluid reservoir.

1 - 29 . (canceled) 
     
     
         30 . A bodily-fluid transfer device, the transfer device comprising:
 a housing defining an inner volume in fluid communication with an inlet port configured to receive bodily-fluid from a patient; and   an actuator mechanism disposed in the inner volume of the housing and configured to be transitioned from a first configuration to a second configuration to allow an initial volume of bodily-fluid to flow into a pre-sample reservoir in a portion of the actuator mechanism,   after the initial volume is in the pre-sample reservoir, the actuator mechanism configured to be transitioned from the second configuration to a third configuration to allow a subsequent volume of bodily-fluid to flow into a sample reservoir outside of the actuator mechanism, and   after the subsequent volume of bodily-fluid is in the sample reservoir, the transfer device configured to receive a portion of an external fluid reservoir to allow at least a portion of the subsequent volume of bodily-fluid to flow from the sample reservoir to the external fluid reservoir via an outlet port separate from the inlet port.   
     
     
         31 . The transfer device of  claim 30 , wherein the actuator mechanism has a first member and a second member,
 at least a portion of the second member configured to move relative to each of the housing and the first member to transition the actuator mechanism from the first configuration to the second configuration, and   the first member and the second member move together after the actuator mechanism is in the second configuration to transition the actuator mechanism from the second configuration to the third configuration.   
     
     
         32 . The transfer device of  claim 30 , wherein the actuator mechanism has a first member and a second member, the pre-sample reservoir is positioned in the first member. 
     
     
         33 . The transfer device of  claim 32 , wherein the first member forms a channel, the inlet port and the channel collectively define a fluid flow path that allows the initial volume of bodily-fluid to flow from the inlet port to the pre-sample reservoir in response to the actuator mechanism transitioning from the first configuration to the second configuration. 
     
     
         34 . The transfer device of  claim 33 , wherein the actuator mechanism includes a valve in the channel of the first member,
 the valve is in an open state to allow the initial volume of bodily-fluid to flow through the fluid flow path in response to a negative pressure differential in the pre-sample reservoir as a result of the actuator being moved from the first configuration to the second configuration, and   the valve is in a closed state when the actuator mechanism is transitioned from the second configuration to the third configuration.   
     
     
         35 . The transfer device of  claim 30 , wherein the actuator mechanism has a first member and a second member, the first member including a plunger, a portion of the inner volume of the housing between the inlet port and the plunger of the first member forming the sample reservoir. 
     
     
         36 . The transfer device of  claim 35 , wherein the outlet port is disposed in a portion of the actuator mechanism proximal to the plunger, the portion of the actuator mechanism proximal to the plunger is configured to receive a portion of the external fluid reservoir when the actuator mechanism is in the third configuration. 
     
     
         37 . The transfer device of  claim 36 , wherein the outlet port is coupled to a puncture member configured to puncture a seal of the external fluid reservoir when the portion of the actuator receives the portion of the external fluid reservoir. 
     
     
         38 . A bodily-fluid transfer device, the transfer device comprising:
 a housing defining an inner volume in fluid communication with an inlet port configured to receive bodily-fluid from a patient; and   an actuator mechanism disposed in the inner volume of the housing and having an outlet port separate from the inlet port, the actuator mechanism configured to be transitioned from a first configuration to a second configuration to allow an initial volume of bodily-fluid to flow into a pre-sample reservoir in a portion of the actuator mechanism,   after the initial volume is in the pre-sample reservoir, the actuator mechanism configured to be transitioned from the second configuration to a third configuration to allow a subsequent volume of bodily-fluid to flow into a sample reservoir outside of the actuator mechanism, and   after the subsequent volume of bodily-fluid is in the sample reservoir, a portion of the actuator mechanism configured to receive a portion of an external fluid reservoir such that the sample reservoir is placed in fluid communication with the external fluid reservoir via the outlet to allow at least a portion of the subsequent volume of bodily-fluid to flow from the sample reservoir to the external fluid reservoir.   
     
     
         39 . The transfer device of  claim 38 , wherein the actuator mechanism has a first member and a second member,
 at least a portion of the second member configured to move relative to each of the housing and the first member to transition the actuator mechanism from the first configuration to the second configuration, and   the first member and the second member move together after the actuator mechanism is in the second configuration to transition the actuator mechanism from the second configuration to the third configuration.   
     
     
         40 . The transfer device of  claim 38 , wherein the actuator mechanism has a first member and a second member, the pre-sample reservoir is positioned in the first member. 
     
     
         41 . The transfer device of  claim 40 , wherein the first member forms a channel, the inlet port and the channel collectively define a fluid flow path that allows the initial volume of bodily-fluid to flow from the inlet port to the pre-sample reservoir in response to the actuator mechanism transitioning from the first configuration to the second configuration. 
     
     
         42 . The transfer device of  claim 41 , wherein the actuator mechanism includes a valve in the channel of the first member,
 the valve is in an open state to allow the initial volume of bodily-fluid to flow through the fluid flow path in response to a negative pressure differential in the pre-sample reservoir as a result of the actuator being moved from the first configuration to the second configuration, and   the valve is in a closed state when the actuator mechanism is transitioned from the second configuration to the third configuration.   
     
     
         43 . The transfer device of  claim 38 , wherein the actuator mechanism has a first member and a second member, the first member including a plunger, a portion of the inner volume of the housing between the inlet port and the plunger of the first member forming the sample reservoir. 
     
     
         44 . The transfer device of  claim 48 , wherein the outlet port is proximal to the plunger and is coupled to a puncture member configured to puncture a seal of the external fluid reservoir when the portion of the actuator receives the portion of the external fluid reservoir. 
     
     
         45 . A bodily-fluid transfer device, the transfer device comprising:
 a housing defining an inner volume in fluid communication with an inlet port configured to receive bodily-fluid from a patient; and   an actuator mechanism disposed in the inner volume of the housing and having first member and a second member at least partially disposed in the first member,   the second member configured to be moved relative to each of the housing and the first member to transition the actuator mechanism from the first configuration to the second configuration and allow an initial volume of bodily-fluid to flow into a pre-sample reservoir positioned in the first member,   after the initial volume is in the pre-sample reservoir, the first member and the second member configured to be moved together relative to the housing to transition the actuator from the second configuration to a third configuration and allow a subsequent volume of bodily-fluid to flow into a sample reservoir in the housing and outside of the first member, and   after the subsequent volume of bodily-fluid is in the sample reservoir, the actuator mechanism configured to receive a portion of an external fluid reservoir to allow at least a portion of the subsequent volume of bodily-fluid to flow from the sample reservoir to the external fluid reservoir via an outlet port separate from the inlet port.   
     
     
         46 . The transfer device of  claim 45 , wherein the first member forms a channel, the inlet port and the channel collectively define a fluid flow path that allows the initial volume of bodily-fluid to flow from the inlet port to the pre-sample reservoir in response to the actuator mechanism transitioning from the first configuration to the second configuration. 
     
     
         47 . The transfer device of  claim 46 , wherein the actuator mechanism includes a valve in the channel of the first member,
 the valve is in an open state to allow the initial volume of bodily-fluid to flow through the fluid flow path in response to a negative pressure differential in the pre-sample reservoir as a result of the actuator being moved from the first configuration to the second configuration, and   the valve is in a closed state when the actuator mechanism is transitioned from the second configuration to the third configuration.   
     
     
         48 . The transfer device of  claim 45 , wherein the first member includes a plunger, a portion of the inner volume of the housing between the inlet port and the plunger forming the sample reservoir. 
     
     
         49 . The transfer device of  claim 48 , wherein the outlet port is proximal to the plunger and is coupled to a puncture member configured to puncture a seal of the external fluid reservoir when the portion of the actuator receives the portion of the external fluid reservoir.