Syringe-based fluid diversion mechanism for bodily fluid sampling

Abstract

A syringe-based device includes a housing, a pre-sample reservoir, and an actuator. The housing defines an inner volume between a substantially open proximal end portion and a distal end portion that includes a port couplable to a lumen-defining device. The pre-sample reservoir is fluidically couplable to the port to receive and isolate a first volume of bodily fluid. The actuator is at least partially disposed in the inner volume and has a proximal end portion that includes an engagement portion and a distal end portion that includes a sealing member. The engagement portion is configured to allow a user to selectively move the actuator between a first configuration such that bodily fluid can flow from the port to the pre-sample reservoir, and a second configuration such that bodily fluid can flow from the port to a sample reservoir defined at least in part by the sealing member and the housing.

1 . A syringe-based device for parenterally-procuring bodily fluid samples with reduced contamination from a patient, the device comprising:
 a housing including a proximal end portion and a distal end portion and defining an inner volume therebetween, the proximal end portion being substantially open and the distal end portion having a port configured to be coupled to a lumen-defining device for receiving bodily fluids from the patient;   a pre-sample reservoir fluidically couplable to the port and configured to receive and isolate a first volume of bodily fluid withdrawn from the patient; and   an actuator mechanism at least partially disposed in the inner volume of the housing, the actuator mechanism having a proximal end portion and a distal end portion, the distal end portion including a sealing member and the proximal end portion including an engagement portion configured to allow a user to selectively move the actuator mechanism,   the actuator mechanism configured to move between a first configuration in which the bodily fluid can flow from the port to the pre-sample reservoir, and a second configuration in which the bodily fluid can flow from the port to a sample reservoir, the sample reservoir defined at least in part by the sealing member and the housing.   
     
     
         2 . The device of  claim 1 , wherein the actuator mechanism defines an inner volume between the proximal end portion and the distal end portion of the actuator mechanism. 
     
     
         3 . The device of  claim 2 , wherein the pre-sample reservoir is disposed in the inner volume of the actuator mechanism. 
     
     
         4 . The device of  claim 2 , wherein the proximal end portion of the actuator mechanism is substantially open and configured to receive a vacuum-sealed sample tube. 
     
     
         5 . The device of  claim 2 , further comprising:
 a piercing member disposed in the inner volume of the actuator mechanism and configured to be fluidically coupled to the port to provide selective communication between the port and the inner volume defined by the actuator mechanism.   
     
     
         6 . The device of  claim 2 , further comprising:
 a flow control mechanism operable to selectively control fluid flow between the port and the pre-sample reservoir, the flow control mechanism being configured to be moved between a first configuration in which the bodily fluid can flow through a first flow path to the pre-sample reservoir, and a second configuration in which the bodily fluid can flow through a second flow path to the sample reservoir.   
     
     
         7 . A syringe-based device for parenterally-procuring bodily fluid samples with reduced contamination from a patient, the device comprising:
 a housing including a proximal end portion and a distal end portion and defining an inner volume therebetween, the proximal end portion being substantially open and the distal end portion having a port configured to be coupled to a lumen-defining device for receiving bodily fluids from the patient; and   an actuator mechanism movably disposed in the inner volume, the actuator mechanism including a first member having a proximal end portion and a distal end portion and defining an inner volume therebetween, and a second member movably disposed in the inner volume of the first member,   the first member including a first plunger disposed at the distal end portion of the first member, the first plunger including a flow channel configured to allow selective fluid communication between the inner volume defined by the housing and the inner volume defined by the first member, and   the second member including a second plunger disposed at a distal end portion of the second member and an engagement portion configured to allow a user to selectively move the actuator mechanism.   
     
     
         8 . The device of  claim 7 , further comprising:
 a valve disposed in the flow channel.   
     
     
         9 . The device of  claim 8 , wherein the valve is a check valve. 
     
     
         10 . The device of  claim 7 , further comprising:
 mechanical stops configured to prevent removal of the actuator mechanism from the housing.   
     
     
         11 . The device of  claim 7 , wherein the actuator mechanism is configured to be moved from a first configuration to a second configuration by application of a first force on the engagement portion in a proximal direction, the first plunger, the second plunger, and the first member of the actuator mechanism collectively defining a first fluid reservoir in the second configuration. 
     
     
         12 . The device of  claim 11 , wherein the actuator mechanism is configured to be moved from the second configuration to a third configuration by application of a second force on the engagement portion in the proximal direction, the first plunger and the housing defining a second fluid reservoir in the third configuration. 
     
     
         13 . The device of  claim 12 , wherein the first fluid reservoir is fluidically isolated from the second fluid reservoir in the third configuration. 
     
     
         14 . The device of  claim 12 , wherein the first force is substantially the same as the second force. 
     
     
         15 . The device of  claim 12 , wherein the second force is greater than the first force. 
     
     
         16 . A syringe-based device for parenterally-procuring bodily fluid samples with reduced contamination from a patient, the device comprising:
 a housing including a proximal end portion and a distal end portion and defining an inner volume therebetween, the proximal end portion being substantially open and the distal end portion having a port configured to be coupled to a lumen-defining device for receiving bodily fluids from the patient;   an actuator mechanism movably disposed in the inner volume of the housing, the actuator mechanism having a proximal end portion and a distal end portion and defining an inner volume therebetween, the distal end portion including a plunger having a flow channel and the proximal end portion being substantially open and configured to receive a vacuum-sealed sample tube; and   a piercing member disposed in the inner volume of the actuator mechanism, the piercing member defining a lumen fluidically coupled to the flow channel of the plunger, the flow channel and the piercing member configured to allow selective fluid communication between the inner volume defined by the housing and the inner volume defined by the actuator mechanism.   
     
     
         17 . The device of  claim 16 , further comprising:
 a valve disposed in at least one of the flow channel and the piercing member.   
     
     
         18 . The device of  claim 16 , wherein the piercing member is a needle. 
     
     
         19 . The device of  claim 16 , wherein the actuator mechanism is configured to be moved from a first configuration to a second configuration, the plunger and the housing defining a fluid reservoir in the second configuration. 
     
     
         20 . The device of  claim 19 , further comprising:
 a sheath disposed on the piercing member, the sheath configured to fluidically isolate the fluid reservoir from the atmosphere in the second configuration.   
     
     
         21 .- 34 . (canceled)