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 system for storing a biological sample for transfer between two different environments is provided. The system includes a first container defining a first container interior, and a second container defining a second container interior. A first closure is provided for enclosing the open end of the first container, with the first closure adapted to receive a sample holder. A second closure is also provided for enclosing the open end of the second container. The first container is adapted to removably receive the sample holder therein when the first closure encloses the open end of the first container, and the second container is adapted to subsequently receive the same sample holder therein when the first closure encloses the open end of the second container.

Abstract: A biological fluid sampling transfer device that is adapted to receive and separate a multi-component blood sample is disclosed. After separation, the biological fluid sampling transfer device is able to transfer a plasma portion of the blood sample to a point-of-care testing device. The biological fluid sampling transfer device of the present disclosure 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 an anticoagulant. 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 blood collection device adapted to receive a multi-component blood sample is disclosed. After collecting the blood sample, the blood collection device separates a plasma portion from a cellular portion. After separation, the blood collection device is able to transfer the plasma portion of the blood sample to a point-of-care testing device. The blood collection device of the present disclosure also provides a closed collection and transfer system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer. The blood collection device is engageable with a blood testing device for closed transfer of a portion of the plasma portion from the blood collection 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 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 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 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 regulator for in-line modulation of the flow rate of fluid during blood collection includes a fluid transfer device for transferring fluid from a patient to a collection device. The fluid transfer device comprises a fluid passageway defined by a tubular sidewall and a flexible member associated with a portion of the tubular sidewall. The flexible member is configured for movement with respect to the fluid passageway upon exposure of the fluid transfer device to a differential pressure during a blood collection procedure to prevent collapse of a patients blood vessel. The flexible member of the regulator can be a frame surrounding a flexible diaphragm. Alternatively, the flexible member can include a flexible material integrally formed within the tubular sidewall of the pressure regulator.

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 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.

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 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 lancet device including a housing and a lancet structure having a puncturing element. The lancet structure disposed within the housing and adapted for movement between a retaining or pre-actuated position wherein the puncturing element is retained within the housing, and a puncturing position wherein the puncturing element extends through a forward end of the housing. The lancet device includes a drive spring disposed within the housing for biasing the lancet structure toward the puncturing position, and a retaining hub retaining the lancet structure in the retracted position against the bias of the drive spring. The retaining hub includes a pivotal lever in interference engagement with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rearward end of the housing to at least partially compress the drive spring, and releasing the lever from interference engagement with the lancet structure.

Abstract: A shieldable needle device including a shield assembly having a first shield member extending from a first side of a hub and a second shield member extending from a second side of the hub, the second side being substantially opposite the first side is disclosed. The shield assembly is pivotable between an open position in which a needle cannula is exposed and the first shield member is spaced apart from the second shield member and a shield position in which the first shield member contacts the second shield member and at least a portion of the first shield member and the second shield member are disposed over the distal end of the needle cannula. In one embodiment, the hub, the first shield member, and the second shield member form an integral component.

Abstract: A lancet device including a housing and a lancet structure having a puncturing element. The lancet structure disposed within the housing and adapted for movement between a retaining or pre-actuated position wherein the puncturing element is retained within the housing, and a puncturing position wherein the puncturing element extends through a forward end of the housing. The lancet device includes a drive spring disposed within the housing for biasing the lancet structure toward the puncturing position, and a retaining hub retaining the lancet structure in the retracted position against the bias of the drive spring. The retaining hub includes a pivotal lever in interference engagement with the lancet structure. An actuator within the housing pivots the lever, thereby moving the lancet structure toward the rearward end of the housing to at least partially compress the drive spring, and releasing the lever from interference engagement with the lancet structure.

Abstract: A blood collection assembly includes a housing and a cannula extending distally from the housing including a patient end, and a cannula shield removably engaged with a portion of the housing. The cannula shield is capable of shielding at least the patient end of the cannula, and includes a safety shield engagement. The assembly includes a pivoting safety shield engaged with a portion of the housing, which is transitionable from a retracted position in which the patient end of the cannula is exposed, to an extended position in which the patient end of the cannula is shielded by at least a portion of the safety shield. The safety shield includes at least one locking tab releasably engageable with the safety shield engagement, wherein the locking tab is fixedly engageable with a portion of the housing in the extended position.

Abstract: A specimen collection container having a transitional fill-volume indicator is disclosed. The specimen collection container includes an open top end, a closed bottom end, and a sidewall extending therebetween defining an interior. The specimen collection container includes a transitional fill-volume indicator adjacent the sidewall, such that the container defines a first volumetric interior defined by the sidewall between the closed bottom end and the transitional indicator. The specimen collection container also defines a second volumetric interior defined by the sidewall between the closed bottom end and a portion of the sidewall disposed above the transitional indicator.

Abstract: A blood collection assembly includes a housing and a cannula extending distally from the housing including a patient end, and a cannula shield removably engaged with a portion of the housing. The cannula shield is capable of shielding at least the patient end of the cannula, and includes a safety shield engagement. The assembly includes a pivoting safety shield engaged with a portion of the housing, which is transitionable from a retracted position in which the patient end of the cannula is exposed, to an extended position in which the patient end of the cannula is shielded by at least a portion of the safety shield. The safety shield includes at least one locking tab releasably engageable with the safety shield engagement, wherein the locking tab is fixedly engageable with a portion of the housing in the extended position.