Abstract: A fluid control device includes an inlet configured to be placed directly or indirectly in fluid communication with a bodily fluid source and an outlet configured to be placed in fluid communication with a fluid collection device. The fluid control device has a first state in which a negative pressure differential produced from an external source such as the fluid collection device is applied to the fluid control device to draw an initial volume of bodily fluid from the bodily fluid source, through the inlet, and into a sequestration portion of the fluid control device. The fluid control device has a second state in which (1) the sequestration portion sequesters the initial volume, and (2) the negative pressure differential draws a subsequent volume of bodily fluid, being substantially free of contaminants, from the bodily fluid source, through the fluid control device, and into the fluid collection device.

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.

Abstract: A fluid control device includes an inlet configured to be placed in fluid communication with a bodily fluid source and an outlet configured to be placed in fluid communication with a fluid collection device, which can produce a negative pressure differential between the outlet and the inlet. A sequestration portion is in fluid communication with the inlet and includes a first flow controller configured to transition from a first state to a second state to place the sequestration portion in fluid communication with the outlet when the negative pressure differential has a first magnitude. A sampling portion is in fluid communication with an outlet and includes a second flow controller configured to transition from a first state to a second state to place the sampling portion in fluid communication with the inlet when the negative pressure differential has a second magnitude greater than the first magnitude.

Abstract: A fluid transfer device for parenterally transferring fluid to and/or from a patient includes a housing, a needle, and an occlusion mechanism. The housing defines a fluid flow path and is couplable to a fluid reservoir. The needle has a distal end portion that is configured to be inserted into the patient and a proximal end portion that is configured to be fluidically coupled to the fluid flow path of the housing, and defines a lumen therebetween. The occlusion mechanism selectively controls a fluid flow between the needle and the fluid flow path. The occlusion mechanism includes an occlusion member that is movable between a first configuration where the lumen of the needle is obstructed during insertion into the patient and a second configuration where the lumen of the needle is unobstructed after the needle has been inserted into the patient allowing fluid transfer to or from the patient.

Abstract: A fluid control device includes an inlet configured to be placed in fluid communication with a bodily fluid source and an outlet configured to be placed in fluid communication with a fluid collection device. The fluid control device has sequestration portion that can be vented or evacuated. The fluid control device has a first state in which an initial volume of bodily fluid can flow from the inlet to the sequestration portion and a second state in which (1) the initial volume is sequestered in the sequestration portion, and (2) a subsequent volume of bodily fluid, being substantially free of contaminants, can flow through at least a portion of the fluid control device and into the fluid collection device. The fluid control device can transition automatically or in response to an actuation of a portion of the fluid control device after the sequestration portion receives the initial volume.

Abstract: An apparatus includes a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing defines an inner volume and has an inlet port that can be fluidically coupled to a patient and an outlet port. The fluid reservoir is disposed in the inner volume to receive and isolate a first volume of a bodily-fluid. The flow control mechanism is rotatable in the housing from a first configuration, in which a first lumen places the inlet port is in fluid communication with the fluid reservoir, and a second configuration, in which a second lumen places the inlet port in fluid communication with the outlet port. The actuator is configured to create a negative pressure in the fluid reservoir and is configured to rotate the flow control mechanism from the first configuration to the second configuration after the first volume of bodily-fluid is received in the fluid reservoir.

Abstract: An apparatus includes a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing defines an inner volume and has an inlet port that can be fluidically coupled to a patient and an outlet port. The fluid reservoir is disposed in the inner volume to receive and isolate a first volume of a bodily-fluid. The flow control mechanism is rotatable in the housing from a first configuration, in which a first lumen places the inlet port is in fluid communication with the fluid reservoir, and a second configuration, in which a second lumen places the inlet port in fluid communication with the outlet port. The actuator is configured to create a negative pressure in the fluid reservoir and is configured to rotate the flow control mechanism from the first configuration to the second configuration after the first volume of bodily-fluid is received in the fluid reservoir.

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.

Abstract: A fluid control device includes an inlet configured to be placed directly or indirectly in fluid communication with a bodily fluid source and an outlet configured to be placed in fluid communication with a fluid collection device. The fluid control device has a first state in which a negative pressure differential produced from an external source such as the fluid collection device is applied to the fluid control device to draw an initial volume of bodily fluid from the bodily fluid source, through the inlet, and into a sequestration portion of the fluid control device. The fluid control device has a second state in which (1) the sequestration portion sequesters the initial volume, and (2) the negative pressure differential draws a subsequent volume of bodily fluid, being substantially free of contaminants, from the bodily fluid source, through the fluid control device, and into the fluid collection device.

Abstract: An apparatus includes an inlet configured to be placed in fluid communication with a bodily fluid source and an outlet configured to be placed in fluid communication with a fluid collection device. A sequestration portion can be configured to receive an initial volume of bodily fluid. A flow controller disposed in the sequestration portion can be configured to transition from a first state to a second state in response to contact with the initial volume of bodily fluid. As the flow controller transitions, a negative pressure differential can be defined that is operable to draw the initial volume of bodily fluid into the sequestration portion. When the flow controller is in the second state, the negative pressure differential can be substantially equalized such that (1) the sequestration portion sequesters the initial volume and (2) a subsequent volume of bodily fluid can be transferred from the inlet to the outlet.

Abstract: A fluid control device includes an inlet configured to be placed in fluid communication with a bodily fluid source and an outlet configured to be placed in fluid communication with a fluid collection device, which can produce a negative pressure differential between the outlet and the inlet. A sequestration portion is in fluid communication with the inlet and includes a first flow controller configured to transition from a first state to a second state to place the sequestration portion in fluid communication with the outlet when the negative pressure differential has a first magnitude. A sampling portion is in fluid communication with an outlet and includes a second flow controller configured to transition from a first state to a second state to place the sampling portion in fluid communication with the inlet when the negative pressure differential has a second magnitude greater than the first magnitude.

Abstract: A fluid control device includes an inlet configured to be placed in fluid communication with a bodily fluid source and an outlet configured to be placed in fluid communication with a fluid collection device, which can produce a negative pressure differential between the outlet and the inlet. A sequestration portion is in fluid communication with the inlet and includes a first flow controller configured to transition from a first state to a second state to place the sequestration portion in fluid communication with the outlet when the negative pressure differential has a first magnitude. A sampling portion is in fluid communication with an outlet and includes a second flow controller configured to transition from a first state to a second state to place the sampling portion in fluid communication with the inlet when the negative pressure differential has a second magnitude greater than the first magnitude.

Abstract: An apparatus includes a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing defines an inner volume and has an inlet port that can be fluidically coupled to a patient and an outlet port. The fluid reservoir is disposed in the inner volume to receive and isolate a first volume of a bodily-fluid. The flow control mechanism is rotatable in the housing from a first configuration, in which a first lumen places the inlet port is in fluid communication with the fluid reservoir, and a second configuration, in which a second lumen places the inlet port in fluid communication with the outlet port. The actuator is configured to create a negative pressure in the fluid reservoir and is configured to rotate the flow control mechanism from the first configuration to the second configuration after the first volume of bodily-fluid is received in the fluid reservoir.

Abstract: An apparatus includes a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing defines an inner volume and has an inlet port that can be fluidically coupled to a patient and an outlet port. The fluid reservoir is disposed in the inner volume to receive and isolate a first volume of a bodily-fluid. The flow control mechanism is rotatable in the housing from a first configuration, in which a first lumen places the inlet port is in fluid communication with the fluid reservoir, and a second configuration, in which a second lumen places the inlet port in fluid communication with the outlet port. The actuator is configured to create a negative pressure in the fluid reservoir and is configured to rotate the flow control mechanism from the first configuration to the second configuration after the first volume of bodily-fluid is received in the fluid reservoir.

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.

Abstract: An apparatus includes a housing, a fluid reservoir, a flow control mechanism, and an actuator. The housing defines an inner volume and has an inlet port that can be fluidically coupled to a patient and an outlet port. The fluid reservoir is disposed in the inner volume to receive and isolate a first volume of a bodily-fluid. The flow control mechanism is rotatable in the housing from a first configuration, in which a first lumen places the inlet port is in fluid communication with the fluid reservoir, and a second configuration, in which a second lumen places the inlet port in fluid communication with the outlet port. The actuator is configured to create a negative pressure in the fluid reservoir and is configured to rotate the flow control mechanism from the first configuration to the second configuration after the first volume of bodily-fluid is received in the fluid reservoir.

Abstract: An apparatus includes a housing defining an inner volume, a distal coupler at least temporarily coupled to a distal end portion of the housing and configured to be placed in fluid communication with a bodily fluid source, a fluid communicator disposed in the inner volume, and a lock coupled to the housing. The lock is transitionable between a first configuration in which the lock couples the distal coupler to housing such that a portion of the fluid communicator extends through a seal of the distal coupler to place the distal coupler in fluid communication with a proximal end portion of the housing and a second configuration in which the lock allows for removal of the distal coupler. The lock is configured to be transitioned back to the first configuration after removing the distal coupler to limit access to the fluid communicator via the distal end portion of the housing.

Abstract: A fluid control device includes an inlet configured to be placed directly or indirectly in fluid communication with a bodily fluid source and an outlet configured to be placed in fluid communication with a fluid collection device. The fluid control device has a first state in which a negative pressure differential produced from an external source such as the fluid collection device is applied to the fluid control device to draw an initial volume of bodily fluid from the bodily fluid source, through the inlet, and into a sequestration portion of the fluid control device. The fluid control device has a second state in which (1) the sequestration portion sequesters the initial volume, and (2) the negative pressure differential draws a subsequent volume of bodily fluid, being substantially free of contaminants, from the bodily fluid source, through the fluid control device, and into the fluid collection device.

Abstract: A device includes a pre-sample reservoir, an actuator mechanism, and a diverter. The pre-sample reservoir can be fluidically coupled to a delivery member to receive and isolate a predetermined volume of bodily-fluid withdrawn from a patient. The actuator mechanism is operably coupled to the pre-sample reservoir such that, when actuated, a negative pressure is formed in the pre-sample reservoir that urges the bodily-fluid to flow into the pre-sample reservoir. The diverter can selectively control fluid flow between the delivery member and the pre-sample reservoir. The diverter includes a flow control mechanism that defines a first fluid flow path and a second fluid flow path. The diverter is movable between a first configuration in which the bodily-fluid flows through the first fluid flow path to the pre-sample reservoir, and a second configuration in which the bodily-fluid flows through the second fluid flow path to a sample reservoir coupled to the diverter.