Abstract: A shieldable needle device includes a hub with and a needle cannula having a puncture tip extending from a forward end thereof, and a shield member in telescoping association with the hub. At least one of the hub and the shield member are adapted for relative axial movement with respect to the other between a first position in which the puncture tip of the needle cannula is exposed from a forward end of the shield member and a second position in which the puncture tip of the needle cannula is encompassed within the shield member. A drive member extends between the hub and the shield member, biasing the hub and the shield member axially away from each other. A packaging cover may further extend about the needle cannula, applying external pressure between the cooperating portions of the hub and the shield.

Abstract: A retractable needle assembly includes a housing having a sidewall defining a hollow bore, and an elongate plunger, the distal end of the plunger forming a reservoir within the hollow bore for containing a fluid therein. The plunger is adapted for slideable movement within the hollow bore. The assembly includes a hub disposed within the hollow bore and at least partially supporting a cannula therewith, and a needle retraction member engaged with the hub for manually selectable advancement with respect to a portion of the housing. The needle retraction member may be advanced from an initial position in which at least a portion of the needle is disposed outside the housing, to a retracted position in which the needle is fully surrounded by the housing. The elongate plunger may be advanced about the hub for extracting the fluid into the reservoir or expelling the fluid from the reservoir.

Abstract: A mechanical separator for separating a fluid sample into first and second phases within a collection container is disclosed. The mechanical separator may have a separator body having a through-hole defined therein, with the through-hole adapted for allowing fluid to pass therethrough. The separator body includes a float, having a first density, and a ballast, having a second density greater than the first density. A portion of the float is connected to a portion of the ballast. Optionally, the float may include a first extended tab adjacent a first opening of the through-hole and a second extended tab adjacent the second opening of the through-hole. In certain configurations, the separator body also includes an extended tab band disposed about an outer surface of the float. The separator body may also include an engagement band circumferentially disposed about at least a portion of the separator body.

Abstract: A mechanical separator for separating a fluid sample into first and second phases is disclosed. The mechanical separator includes a float having a passageway extending between first and second ends thereof with a pierceable head enclosing the first end of the float, a ballast longitudinally moveable with respect to the float, and a bellows extending between a portion of the float and a portion of the ballast. The bellows is adapted for deformation upon longitudinal movement of the float and the ballast, with the bellows isolated from the pierceable head. The float has a first density and the ballast has a second density greater than the first density. The bellows is structured for sealing engagement with a cylindrical wall of a tube, and the pierceable head is structured for application of a puncture tip therethrough. The separation device is suitable for use with a standard medical collection tube.

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 mechanical separator for separating a fluid sample into first and second phases within a collection container is disclosed. The mechanical separator may have a separator body having a through-hole defined therein, with the through-hole adapted for allowing fluid to pass therethrough. The separator body includes a float, having a first density, and a ballast, having a second density greater than the first density. A portion of the float is connected to a portion of the ballast. Optionally, the float may include a first extended tab adjacent a first opening of the through-hole and a second extended tab adjacent the second opening of the through-hole. In certain configurations, the separator body also includes an extended tab band disposed about an outer surface of the float. The separator body may also include an engagement band circumferentially disposed about at least a portion of the separator body.

Abstract: A mechanical separator for separating a fluid sample into first and second phases is disclosed. The mechanical separator includes a float having a passageway extending between first and second ends thereof with a pierceable head enclosing the first end of the float, a ballast longitudinally moveable with respect to the float, and a bellows extending between a portion of the float and a portion of the ballast. The bellows is adapted for deformation upon longitudinal movement of the float and the ballast, with the bellows isolated from the pierceable head. The float has a first density and the ballast has a second density greater than the first density. The bellows is structured for sealing engagement with a cylindrical wall of a tube, and the pierceable head is structured for application of a puncture tip therethrough. The separation device is suitable for use with a standard medical collection tube.

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 flow regulator for a blood collection assembly includes a housing having an inlet and an outlet, which defines an interior space between the inlet and the outlet. A membrane having a first surface and a second surface is disposed at least partially within the interior space. The membrane has a first position where a flow path between the inlet and the outlet is substantially open, and a second position where the flow path between the inlet and the outlet is at least partially restricted. The membrane is configured to move between the first and second positions in response to a pressure differential acting on the membrane.

Abstract: A mechanical separator for separating a fluid sample into first and second phases is disclosed. The mechanical separator includes a float having a passageway extending between first and second ends thereof with a pierceable head enclosing the first end of the float, a ballast longitudinally moveable with respect to the float, and a bellows extending between a portion of the float and a portion of the ballast. The bellows is adapted for deformation upon longitudinal movement of the float and the ballast, with the bellows isolated from the pierceable head. The float has a first density and the ballast has a second density greater than the first density. The bellows is structured for sealing engagement with a cylindrical wall of a tube, and the pierceable head is structured for application of a puncture tip therethrough. The separation device is suitable for use with a standard medical collection tube.

Abstract: A shieldable needle device includes a hub with and a needle cannula having a puncture tip extending from a forward end thereof, and a shield member in telescoping association with the hub. At least one of the hub and the shield member are adapted for relative axial movement with respect to the other between a first position in which the puncture tip of the needle cannula is exposed from a forward end of the shield member and a second position in which the puncture tip of the needle cannula is encompassed within the shield member. A drive member extends between the hub and the shield member, biasing the hub and the shield member axially away from each other. A packaging cover may further extend about the needle cannula, applying external pressure between the cooperating portions of the hub and the shield.

Abstract: A mechanical separator for separating a fluid sample into first and second phases is disclosed. The mechanical separator includes a float having a passageway extending between first and second ends thereof with a pierceable head enclosing the first end of the float, a ballast longitudinally moveable with respect to the float, and a bellows extending between a portion of the float and a portion of the ballast. The bellows is adapted for deformation upon longitudinal movement of the float and the ballast, with the bellows isolated from the pierceable head. The float has a first density and the ballast has a second density greater than the first density. The bellows is structured for sealing engagement with a cylindrical wall of a tube, and the pierceable head is structured for application of a puncture tip therethrough. The separation device is suitable for use with a standard medical collection tube.

Abstract: A shieldable needle device includes a hub with and a needle cannula having a puncture tip extending from a forward end thereof, and a shield member in telescoping association with the hub. At least one of the hub and the shield member are adapted for relative axial movement with respect to the other between a first position in which the puncture tip of the needle cannula is exposed from a forward end of the shield member and a second position in which the puncture tip of the needle cannula is encompassed within the shield member. A drive member extends between the hub and the shield member, biasing the hub and the shield member axially away from each other. A packaging cover may further extend about the needle cannula, applying external pressure between the cooperating portions of the hub and the shield.

Abstract: A mechanical separator for separating a fluid sample into first and second phases within a collection container is disclosed. The mechanical separator may have a separator body having a through-hole defined therein, with the through-hole adapted for allowing fluid to pass therethrough. The separator body includes a float, having a first density, and a ballast, having a second density greater than the first density. A portion of the float is connected to a portion of the ballast. Optionally, the float may include a first extended tab adjacent a first opening of the through-hole and a second extended tab adjacent the second opening of the through-hole. In certain configurations, the separator body also includes an extended tab band disposed about an outer surface of the float. The separator body may also include an engagement band circumferentially disposed about at least a portion of the separator body.

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 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 biological sample containment system that includes a biological specimen collection container for collecting a biological sample and a label for the container is disclosed. In one embodiment, the label includes a first or front side and a second or rear side having a readable information portion. The label is affixable to the container by the second side and with the label affixed to the container, the readable information portion on the second side is readable through a portion of the container. By including readable information on the second or rear side of the label, the amount of readable information that can be included on the label is increased by using the previously unused rear side of the label.

Abstract: A mechanical separator for separating a fluid sample into first and second phases within a collection container is disclosed. The mechanical separator may have a separator body having a through-hole defined therein, with the through-hole adapted for allowing fluid to pass therethrough. The separator body includes a float, having a first density, and a ballast, having a second density greater than the first density. A portion of the float is connected to a portion of the ballast. Optionally, the float may include a first extended tab adjacent a first opening of the through-hole and a second extended tab adjacent the second opening of the through-hole. In certain configurations, the separator body also includes an extended tab band disposed about an outer surface of the float. The separator body may also include an engagement band circumferentially disposed about at least a portion of the separator body.

Abstract: A method for detecting the presence of a microorganism in a fluid sample is disclosed. The method includes providing a fluid specimen within a specimen collection container having a sidewall defining an interior therein. The interior includes a mechanical separator adapted for separating the fluid sample into first and second phases within the specimen collection container and a sensing element capable of detecting the presence of a microorganism disposed therein. The method includes subjecting the specimen collection container to applied rotational force to isolate a concentrated microorganism region. The method also includes detecting by a sensing element the presence or absence of a microorganism within the concentrated microorganism region.