A biological fluid collection device that receives a sample and provides flow-through blood stabilization technology and a precise sample dispensing function for point-of-care and near patient testing applications is disclosed. A biological fluid collection device of the present disclosure is able to effectuate distributed mixing of a sample stabilizer within a blood sample and dispense the stabilized sample in a controlled manner. In this manner, a biological fluid collection device of the present disclosure enables blood micro-sample management, e.g., passive mixing with a sample stabilizer and controlled dispensing, for point-of-care and near patient testing applications.

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.

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.

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.

A sensor can be manufactured by printing a working electrode onto a substrate using aerosol jet printing. Sensing chemistry (e.g., enzyme-based ink that including detection chemistry) also can be printed onto the working electrode using aerosol jet printing. A reference electrode also can be printed on the substrate at a position spaced along the substrate from the working electrode. In certain examples, the substrate can be positioned within a lumen of a skin piercing member of a sensor module.

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.

Embodiments in accordance with the present disclosure are directed to sample collecting and dispensing methods and apparatuses. An example apparatus includes a capillary sampler disposed on a device first end, wherein the capillary sampler is configured to collect a fluid sample via an opening and a capillary body. The apparatus further includes a reagents chamber in fluid communication with the capillary sampler, and a barrier assembly disposed between the capillary sampler and the reagents chamber, wherein the barrier assembly is configured to separate fluid in the reagents chamber from the capillary sampler. A plunger assembly disposed on a device second end opposite the device first end, may modify the barrier assembly to dispense the fluid from the reagents chamber to the capillary sampler responsive to application of a force in the direction of the device first end.

A vascular access system may include a catheter assembly, which may include a catheter hub and a catheter extending distally from the catheter hub. The vascular access system may include an instrument advancement device coupled to the catheter assembly. The instrument advancement device may include a vascular access instrument. The vascular access instrument may include a coil formed by a flat wire wound around an axis into multiple loops. The instrument advancement device may be configured to advance the vascular access instrument from a retracted position to an advanced position beyond a distal end of the catheter. The distal end of the catheter may include a distal opening. The coil may extend through the distal opening of the catheter in response to the vascular access instrument being in the advanced position.

A sensor module is disclosed herein. The sensor module includes a skin piercing member carried by the carrier. The skin piercing member has a skin piercing end positioned opposite from a base end. The skin piercing member defines a lumen that extends along the central longitudinal axis from the skin piercing end toward the base end and the lumen having a lumen axis. The sensor module also includes a blood sample analysis zone located entirely within the lumen of the skin piercing member and a capillary flow stop for stopping capillary flow at a predetermined location within the lumen of the skin piercing member. The sensor module includes an elongated working electrode positioned within the lumen. The working electrode has a length that extends along the lumen axis where at least a section of the working electrode is positioned within the analysis zone. The working electrode includes sensing chemistry.