Abstract: A needle shield assembly including a hinged needle shield is provided. A ramp is provided in proximity to a hinge that connects the needle shield to base assembly. The ramp is preferably flexible, and, if compressed, resiliently urges the needle shield to a preferred angular position with respect to a syringe. The needle shield is movable between a fully opened position where it is canted at an angle with respect to the syringe and a closed position in which it envelops the needle. One or more locking elements are preferably provided on the needle shield for maintaining it in a locked, needle protecting position.

Abstract: A luer connector assembly is provided for enhancing the frictional engagement between medical devices such as syringes and needle assemblies. The assembly needle includes a female luer fitting having a passageway and a relatively soft, resilient member bounding the passageway. The passageway is also bounded by the body of the fitting, which is harder than the soft, resilient member. A male luer fitting inserted into the passageway engages both the soft, resilient member and the body of the female luer fitting. A method of manufacturing such a connector assembly is further provided. A first material is injected into a mold to form the body of a female luer fitting, the fitting including a passageway and a recess extending into the body. A second material is then injected such that it extends into the recess and bounds the passageway. The second material, when cool, is softer than the first material.

Abstract: A biological sample containment system and method are provided that include a container for storing the biological sample and an indicator affixed to the container for displaying at least one measured characteristics of the container or sample, wherein measurement of the characteristic is commenced by activation of the indicator. In another embodiment of the invention, a biological sample containment system and method are provided that include a container for storing the biological sample and a colored scale affixed to the container, wherein the colored scale facilitates identification of at least one characteristic of the biological sample. In yet another embodiment of the invention, a biological sample containment system and method are provided that include a container for collecting a biological sample and a label affixed to the container, wherein information relating to the biological sample or container is situated on the label.

Abstract: A luer connector assembly is provided for enhancing the frictional engagement between medical devices such as syringes and needle assemblies. The assembly needle includes a female luer fitting having a passageway and a relatively soft, resilient member bounding the passageway. The passageway is also bounded by the body of the fitting, which is harder than the soft, resilient member. A male luer fitting inserted into the passageway engages both the soft, resilient member and the body of the female luer fitting. A method of manufacturing such a connector assembly is further provided. A first material is injected into a mold to form the body of a female luer fitting, the fitting including a passageway and a recess extending into the body. A second material is then injected such that it extends into the recess and bounds the passageway. The second material, when cool, is softer than the first material.

Abstract: A mechanical separator for separating a fluid sample into first and second phases is disclosed. The mechanical separator includes a float having a first portion and a second portion, a ballast circumferentially disposed about a section of the float, and a deformable bellows defining an open passageway extending between a first end and a second end. The ballast is longitudinally moveable with respect to the float and engaged with the deformable bellows between the first end and the second end. At least a portion of the float is transitionable from a restraint position to a sealed position through the first end of the bellows. The first portion of the float can be positioned within the interior of the deformable bellows in the restraint position, and the first portion of the float can be positioned at an exterior location longitudinally displaced from the deformable bellows in the sealed position.

Abstract: The blood collection set includes an IV needle assembly, a length of flexible plastic tubing extending from the IV needle assembly and a non-patient needle assembly. The set is formed with a venting mechanism that permits an outflow of air, while blocking an outflow of blood or other fluids. Thus, the venting mechanism enables air that had existed in interior portions of the blood collection set to be vented allowing for greater flash visualization on venous entry, and avoids the need to employ a discard 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 container for storing a biological sample is disclosed. The container includes a first chamber having a sidewall extending between an open end and a closed end, defining a first chamber interior adapted to receive a sample holder therein. The container also includes a second chamber having a sidewall extending between an open end and a closed end, defining a second chamber interior adapted to subsequently receive the sample holder therein. The second chamber interior is in fluid isolation from the first chamber interior. A removable closure encloses at least one of the open end of the first chamber and the open end of the second chamber while the sample holder is disposed within one of the first chamber interior and the second chamber interior. A first fluid may be disposed within the first chamber interior, and a second different fluid may be disposed within the second chamber interior.

Abstract: Disclosed is a fluid collection device wherein multiple, individual samples of fluid can be collected simultaneously. The device includes a chamber and an adapter which substantially and simultaneously distributes the blood to individual chambers with chamber specific additives. Also included is a system for using the blood collection device, preferably within a diagnostic testing laboratory.

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 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 container for storing a biological sample for molecular diagnostic testing and/or histological testing is provided. The container includes a first chamber for receiving a sample holder therein, a second chamber, and a closure for enclosing the container. A breakable membrane, such as a piercable foil, extends within the container and separates the two chambers. When the breakable membrane is broken, fluid can pass between the first and second chambers. The membrane may be broken through an activator on the closure, such as a depressible member or a rotatable carrier, causing the sample holder to break through the membrane.

Abstract: A container for storing a biological sample for molecular diagnostic testing and/or histological testing is provided. The container includes a first chamber for receiving a sample holder therein, a second chamber, and a closure for enclosing the container. A transitional barrier, such as a valve, is in fluid communication between the two chambers. The transitional barrier is transitional between a first position in which the first chamber is in fluid isolation from the second chamber, and a second position in which fluid can pass from at least one of the first and second chambers to the other of the first and second chambers.

Abstract: The invention is a self-venting blood collection needle assembly for the extraction of at least one fluid sample into an evacuated container for laboratory testing, this blood collection needle assembly providing a clear or translucent flashback chamber for blood to flow into, for visualization by the user to confirm successful vein entry. The self-venting mechanism permits escape of air during use, and which, typically, also prevents an outflow of fluid, such as blood. Thus, air under venous pressure will be allowed to escape from the blood collection needle assembly until blood reaches the venting mechanism.

Abstract: The present invention is a safety shield assembly having a shield and a collar for connecting the shield to a fluid handling device whereby the shield may be pivoted with respect to the collar. Preferably, the safety shield assembly may be used with a needle assembly, an intravenous infusion set a syringe, a catheter or other fluid handling devices or assemblies that contain piercing elements.

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: The invention is a self-venting blood collection needle assembly for the extraction of at least one fluid sample into an evacuated container for laboratory testing, this blood collection needle assembly providing a clear or translucent flashback chamber for blood to flow into, for visualization by the user to confirm successful vein entry. The self-venting mechanism permits escape of air during use, and which, typically, also prevents an outflow of fluid, such as blood. Thus, air under venous pressure will be allowed to escape from the blood collection needle assembly until blood reaches the venting mechanism.

Abstract: A luer connector assembly is provided for enhancing the frictional engagement between medical devices such as syringes and needle assemblies. The assembly needle includes a female luer fitting having a passageway and a relatively soft, resilient member bounding the passageway. The passageway is also bounded by the body of the fitting, which is harder than the soft, resilient member. A male luer fitting inserted into the passageway engages both the soft, resilient member and the body of the female luer fitting. A method of manufacturing such a connector assembly is further provided. A first material is injected into a mold to form the body of a female luer fitting, the fitting including a passageway and a recess extending into the body. A second material is then injected such that it extends into the recess and bounds the passageway. The second material, when cool, is softer than the first material.

Abstract: The present invention is a method for assembling a safety shield assembly and more particularly a method for assembling a safety shield assembly with a fluid handling device. Preferably, the safety shield assembly may be assembled with a needle assembly, an intravenous infusion set a syringe, a catheter or other fluid handling devices or assemblies that contain piercing elements.