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.

Bodily fluid sample collection systems, devices, and method are provided. The sample is collected at a first location and subjected to a first sample processing step. The sample may be shipped to a second location and subjected to a second sample processing step that does not introduce contaminants into a plasma portion of the sample formed from the first processing step. The sample may also be mixed with other material(s) in the collection device.

An independent blood filter device depends on flow geometry to deliver blood serum or plasma free of detrimental levels of hemoglobin. It depends critically on an upstream flow rate or pressure differential limiting control element or device that limits the rate of change of pressure differential across the filter element. Pre-evacuated versions can be used to simultaneously draw blood from a living being and provide pressure differential across the filter element between an evacuated collector and a supply end open to atmosphere. A unit pressurized by hand motion employs the external shape of a partially filled blood collection tube as a piston to produce pressure in advance of the control element or device to create the pressure differential across the filter element to a collector vented to atmosphere. The control element or device is disclosed in numerous forms, including specially sized flow constrictions and compliant arrangements.

Blood sample optimization systems and methods are described that reduce or eliminate contaminates in collected blood samples, which in turn reduces or eliminates false positive readings in blood cultures or other testing of collected blood samples. A blood sample optimization system can include a blood sequestration device located between a patient needle and a sample needle. The blood sequestration device can include a sequestration chamber for sequestering an initial, potentially contaminated aliquot of blood, and may further include a sampling channel that bypasses the sequestration chamber to convey likely uncontaminated blood between the patient needle and the sample needle after the initial aliquot of blood is sequestered in the sequestration chamber.

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.

A fluid sample optimization device for optimizing a fluid sample collected by a fluid collection device from a fluid source, where a first portion of the fluid sample potentially has contaminants. The device includes an inlet configured to connect with the fluid source, an outlet configured to connect with the fluid collection device, a sample path connected between the inlet and the outlet, and a contaminant containment reservoir connected between the inlet and the outlet. The contaminant containment reservoir has an air permeable fluid resistor proximate the outlet, and is arranged to receive the first portion of the fluid sample from the fluid source to displace air therein, such that upon receipt of the first portion of the fluid sample and containment of the contaminants in the contaminant containment reservoir, subsequent portions of the fluid sample are conveyed by the sample path from the inlet to the outlet when subsequent pressure differentials are applied between the inlet and the outlet. The fluid sample optimization device can further include a displaceable plug between the inlet and the sample path, that can be displaced by the subsequent pressure differentials to allow the subsequent portions of the fluid to be conveyed through the sample path.

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.

An apparatus includes a housing that defines a fluid reservoir and includes a port that is in fluid communication with the fluid reservoir. An inlet adapter is removably coupleable to the housing. A user can engage an actuator to move a plunger from a first position in which the fluid reservoir has a first volume, to a second position in which the fluid reservoir has a second volume greater than the first volume, which draws bodily fluid into the fluid reservoir via the inlet adapter. The actuator modulates a plunger rate of motion below a threshold as the plunger is moved. When a predetermined volume of bodily fluid is transferred into the fluid reservoir, a volume indicator transitions from a first state to a second state and the inlet adapter can then be removed to transfer the predetermined volume into a sample bottle external to the housing via the port.

A blood collection tube includes a body, a chamber, a vacuum port, and a cap. The cap includes a first septum, a first conduit having an inlet extending from the first septum and an outlet in fluid communication with the chamber, a second septum, and a second conduit extending radially from the second septum to the first conduit. When a fluid source is fluidically connected to the first septum or the second septum, and a vacuum is applied at the port, the vacuum draws fluid from the fluid source, through the first or second septum, and into the first conduit. A blood collection device includes a vacuum pump and a plurality of reservoirs containing concentrated blood additives. The tube and device form a system for collecting blood samples at low vacuum to tubes previously stored at atmospheric pressure. The system prevents risk of misidentification, mislabeling, or incorrect ordering of tubes.

A collection device (10) which directs a flow of blood into a container (14) and provides a controlled blood flow path that ensures blood flow from a collection site to a collection container is disclosed.