Abstract: A biological fluid collection system 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 system 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 system 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.

Abstract: A biological fluid collection device that is adapted to receive a blood sample having a cellular portion and a plasma portion is disclosed. After collecting the blood sample, the biological fluid collection device is able to transfer the blood sample to a point-of-care testing device or a biological fluid separation and testing device. After transferring the blood sample, the biological fluid separation and testing device is able to separate the plasma portion from the cellular portion and analyze the blood sample and obtain test results.

Abstract: A biological fluid sampling transfer device adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the biological fluid sampling transfer device is able to separate a plasma portion from a cellular portion. After separation, the biological fluid sampling transfer device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid sampling transfer device also provides a closed sampling and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The biological fluid sampling transfer device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the biological fluid sampling transfer device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.

Abstract: A biological fluid collection device that includes a housing and a cartridge that is removably receivable within a portion of the housing is disclosed. The biological fluid collection device of the present disclosure allows for collection of capillary blood from a finger stick and provides a closed system that reduces the exposure of a blood sample. In one embodiment, a cartridge of the present disclosure also provides fast mixing of a blood sample with a sample stabilizer. In another embodiment, a cartridge of the present disclosure provides automatic plasma separation of the blood sample. Advantageously, once the cartridge is filled with a sample aid removed from the housing, the cartridge can be used for a variety of important purposes.

Abstract: A specimen collection assembly including a flow control member for adjustably altering a flow path is disclosed. In one configuration, the flow control member defines a regulation channel in fluid communication with a lumen of a cannula, wherein the flow control member is configured to adjustably alter an effective flow distance between the lumen of the cannula and an interior of an evacuated collection container. In another configuration, the flow control member is positioned to vary an effective cross-sectional area of at least one of an inlet port and an outlet port adapted to be in fluid communication with the lumen and the evacuated collection container.

Abstract: A specimen transfer device adapted to receive a blood sample is disclosed. The specimen transfer device includes a housing and an actuation member. A deformable material is disposed within the housing and is deformable from an initial position in which the material is adapted to hold the sample to a deformed position in which at least a portion of the sample is released from the material. A viscoelastic member is disposed within the housing between the material and the housing and between the material and the actuation member. The viscoelastic member is engaged with the actuation member and the material such that movement of the actuation member from a first position to a second position deforms the material from the initial position to the deformed position.

Abstract: A specimen collection assembly (100) including a flow control member (106) for adjustably altering a flow path is disclosed. In one configuration, the flow control member (106) defines a regulation channel (166) in fluid communication with a lumen of a cannula (112), wherein the flow control member (106) is configured to adjustably alter an effective flow distance between the lumen of the cannula (112) and an interior of an evacuated collection container. In another configuration, the flow control member (106) is positioned to vary an effective cross-sectional area of at least one of an inlet port (346) and an outlet port (350) adapted to be in fluid communication with the lumen and the evacuated collection container.

Abstract: A container for storing a biological sample is disclosed. The container includes a housing having a closed end, an open end, and a sidewall extending therebetween defining a container interior. The container has a removable closure for enclosing the open end of the housing and a sample holder for housing a biological sample detachably connected to the closure and insertable within the container interior. A port is disposed within the closure adjacent the sample holder to allow fluid to pass therethrough into the container interior. An injection device for engaging the port may also be provided. A first fluid may be initially provided within the container interior and a second fluid may be subsequently injected by the injection device through the port into the container interior.

Abstract: A shieldable needle device including a drive member is disclosed. The drive member is extendable between a biased position and an extended position for moving a tip guard from an first position to a second position in which the tip guard shields a distal end of the needle cannula. The shieldable needle device includes a pair of wings extending laterally from opposing sides of the hub that are movable between a laterally extending position and a dorsal position. With the wings in the dorsal position, the wings retain the drive member in the biased position thereby maintaining the tip guard in the first position. Movement of the wings from the dorsal position to the laterally extending position releases retainment of the drive member. A second drive member may be included.

Abstract: A specimen transfer device adapted to receive a blood sample is disclosed. The specimen transfer device includes a housing and an actuation member. A deformable material is disposed within the housing and is deformable from an initial position in which the material is adapted to hold the sample to a deformed position in which at least a portion of the sample is released from the material. A viscoelastic member is disposed within the housing between the material and the housing and between the material and the actuation member. The viscoelastic member is engaged with the actuation member and the material such that movement of the actuation member from a first position to a second position deforms the material from the initial position to the deformed position.

Abstract: A needle assembly is disclosed. The needle assembly includes a housing having a flash chamber, and having a distal end and a proximal end engageable with a specimen collection container. The assembly includes a cannula having a patient end, a non-patient end, and a sidewall extending therebetween defining a cannula interior. The patient end of the cannula projects at least partially from the distal end of the housing, and the cannula interior is in fluid communication with the flash chamber. The assembly further includes a shield restrainably engaged with a portion of the housing and axially transitionable over the patient cannula from a retracted position in which the patient end is exposed, to an extended position in which the patient end is shielded by at least a portion of the shield, wherein at least a portion of the flash chamber is visible in the retracted position.

Abstract: A container assembly is disclosed including an outer container, a hollow inner member, and a closure. The outer container has a closed bottom, an open top, and a sidewall extending therebetween. The hollow inner member is disposed within the outer container and has an inner surface defining at least one capillary channel. The inner member includes a first end adjacent to the open top of the outer container and has an outer periphery seated against the sidewall of the outer container. The closure has a proximal end and a distal end. The closure proximal end is seated at least partially within the first end of the inner member to seal the outer container and inner member and define a fluid collection chamber. The closure distal end defines a recessed area shaped to direct fluid under capillary action to the at least one capillary channel in the inner member.

Abstract: A shieldable needle device including a drive member is disclosed. The drive member is extendable between a biased position and an extended position for moving a tip guard from an first position to a second position in which the tip guard shields a distal end of the needle cannula. The shieldable needle device includes a pair of wings extending laterally from opposing sides of the hub that are movable between a laterally extending position and a dorsal position. With the wings in the dorsal position, the wings retain the drive member in the biased position thereby maintaining the tip guard in the first position. Movement of the wings from the dorsal position to the laterally extending position releases retainment of the drive member. A second drive member may be included.

Abstract: A container assembly is disclosed including an outer container, a hollow inner member, and a closure. The outer container has a closed bottom, an open top, and a sidewall extending therebetween. The hollow inner member is disposed within the outer container and has an inner surface defining at least one capillary channel. The inner member includes a first end adjacent to the open top of the outer container and has an outer periphery seated against the sidewall of the outer container. The closure has a proximal end and a distal end. The closure proximal end is seated at least partially within the first end of the inner member to seal the outer container and inner member and define a fluid collection chamber. The closure distal end defines a recessed area shaped to direct fluid under capillary action to the at least one capillary channel in the inner member.

Abstract: A closure having enhanced oxygen barrier capabilities includes a cap body formed from a first material, the cap body defining a cavity therethrough, a stopper formed from a second material, the second material being different than the first material and disposed within the cavity, and a barrier layer formed from a third material, the third material being different than at least the second material and associated with at least one of the cap body and the stopper. A container assembly including a closure and a method of forming the closure is also provided.

Abstract: A regulator for modulation of the flow rate of blood out of a patient's blood vessel during blood collection is disclosed. The regulator includes a housing having a housing inlet, a housing outlet, and a wall defining a housing interior. At least a portion of the wall includes a flexible member. A valve is associated with the flexible member and is in communication with the housing interior. The regulator is designed so that upon an application of a differential pressure within the housing interior, the flexible member and/or valve automatically move with respect to either the housing inlet or housing outlet to modulate a flow of blood moving through the housing. A manual over-ride device can be provided to enable a user to over-ride the automatic regulation and manually regulate the flow of blood through the housing.

Abstract: A biological fluid sampling transfer device adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the biological fluid sampling transfer device is able to separate a plasma portion from a cellular portion. After separation, the biological fluid sampling transfer device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The biological fluid sampling transfer device also provides a closed sampling and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The biological fluid sampling transfer device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the biological fluid sampling transfer device to the blood testing device. The blood testing device is adapted to receive the plasma portion to analyze the blood sample and obtain test results.

Abstract: A closure having enhanced oxygen barrier capabilities includes a cap body formed from a first material, the cap body defining a cavity therethrough, a stopper formed from a second material, the second material being different than the first material and disposed within the cavity, and a barrier layer formed from a third material, the third material being different than at least the second material and associated with at least one of the cap body and the stopper. A container assembly including a closure and a method of forming the closure is also provided.

Abstract: A regulator for modulation of the flow rate of blood out of a patients blood vessel during blood collection is disclosed. The regulator includes a housing having a housing inlet, a housing outlet, and a wall defining a housing interior. At least a portion of the wall includes a flexible member. A valve is associated with the flexible member and is in communication with the housing interior. The regulator is designed so that upon an application of a differential pressure within the housing interior, the flexible member and/or valve automatically move with respect to either the housing inlet or housing outlet to modulate a flow of blood moving through the housing. A manual over-ride device can be provided to enable a user to over-ride the automatic regulation and manually regulate the flow of blood through the housing.

Abstract: A needle assembly is disclosed. The needle assembly includes a housing having a flash chamber, and having a distal end and a proximal end engageable with a specimen collection container. The assembly includes a cannula having a patient end, a non-patient end, and a sidewall extending therebetween defining a cannula interior. The patient end of the cannula projects at least partially from the distal end of the housing, and the cannula interior is in fluid communication with the flash chamber. The assembly further includes a shield restrainably engaged with a portion of the housing and axially transitionable over the patient cannula from a retracted position in which the patient end is exposed, to an extended position in which the patient end is shielded by at least a portion of the shield, wherein at least a portion of the flash chamber is visible in the retracted position.