This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

A blood collection device to prime a blood flow path may include a cannula, a holder, and an elastomeric sleeve. The cannula may include a proximal end, a distal end, and a lumen extending along a longitudinal axis therebetween. The cannula may include a slot to enable a user to visualize the blood flow path through the cannula. The holder may include a channel configured to align with the longitudinal axis to retain a shaft of the cannula. The holder may further include a visual check window corresponding to the slot of the cannula. The elastomeric sleeve may be coupled to the holder and enclose the proximal end of the cannula. A priming opening may be disposed between the elastomeric sleeve and the holder to prime the blood flow path.

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 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.

An arterial blood module (16) that is removably connectable to an arterial blood collection element (14) is disclosed. The arterial blood module includes a housing (30), a needle (32), a cap (34) removably securable over the needle, a mixing chamber (36), and a safety shield (38) engaged with a portion of the housing and transitionable from a first shield position in which a portion of the needle is exposed to a second shield position in which the needle is shielded by a portion of the safety shield. In one embodiment, the present disclosure includes an arterial blood collection system (10) that includes an arterial blood collection element (14) defining a collection chamber (20) and an arterial blood module (16) removably connectable to a portion of the arterial blood collection element.

A biological fluid collection device (10) that receives a sample (12) 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. Advantageously, a biological fluid collection device of the present disclosure includes an internal vacuum (28). In this manner, a biological fluid collection device of the present disclosure eliminates the need for additional vacuum creating components that must be connected to the biological fluid collection device during use.

Apparatuses and methods for dried blood spot (DBS) sample collection are disclosed. A dried blood spot sampling device is configured to deliver blood through a passage to an absorbent disk in the device and control an amount of blood saturating the absorbent disk. The sampling device may include a manually actuatable component adjustable between a first position, in which an outlet of the passage is not in physical contact with the absorbent disk, and a second position, in which the outlet of the passage is in physical contact with the absorbent disk.

A cap with a venting plug for a biological fluid collection device is disclosed. The venting plug allows air to pass therethrough and prevents a blood sample from passing therethrough. In one embodiment, the venting plug is a porous plug. In one embodiment, the cap includes a venting plug including a carboxymethylcellulose additive. A cap that limits analyte bias due to the interaction of plasma ions with the carboxymethylcellulose by reducing the contact area between the blood and the carboxymethylcellulose additive, e.g., decreasing radius, is also disclosed.

A biological fluid collection system (10) including a collection module (14) for collecting a small sample of blood and transferring a portion of the sample into a device or instrument for analyzing the sample such as a point-of-care or a near-patient-testing device including blood collection devices for collecting and transferring venous and arterial blood samples are disclosed.

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.