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: A device for delivering a substance into the skin of a patient includes a body and a skin penetrating device having at least one skin penetrating member, such as a microneedle. The body includes an internal cavity and a device for indicating the delivery of a sufficient amount of the substance to the patient and for producing a dispensing pressure to dispense and deliver the substance from the cavity. The indicating device is visible from the exterior of the delivery device. In some embodiments, the indicating device is an elastic expandable diaphragm which, when the cavity is filled with a substance, creates the dispensing pressure.

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.

Abstract: A shieldable needle device is provided. The shieldable needle device includes a housing, a needle cannula, a tip guard and a flexibly resilient drive mechanism. The housing includes a first lateral extension and a second lateral extension which are interconnected at a rearward end to form a hub portion from which the needle cannula extends. The tip guard telescopes over the needle cannula from a retracted position to an extended position. The drive mechanism is attached to the tip guard and is bent or coiled within the housing between the first and second lateral extension and retained in the bent or coiled position. Upon release of the drive mechanism, the tip guard is moved from a retracted position to an extended position, thereby protectively surrounding a tip of the needle cannula.

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 device for delivering a substance into the skin of a patient includes a body and a skin penetrating device having at least one skin penetrating member, such as a microneedle. The body includes an internal cavity and a device for indicating the delivery of a sufficient amount of the substance to the patient and for producing a dispensing pressure to dispense and deliver the substance from the cavity. The indicating device is visible from the exterior of the delivery device. In some embodiments, the indicating device is an elastic expandable diaphragm which, when the cavity is filled with a substance, creates the dispensing pressure.

Abstract: A collection container for collecting biological fluid specimens having an integral fill-line indicator which corresponds to a desired specimen volume is disclosed. The integral fill-line indicator may comprise a ridge that is raised from the surface of the collection container. The integral fill-line indicator may also be altered by surface modification to impart a distinct visual appearance and/or texture. The collection container may have a single or a plurality of integral fill-line indicators which correspond to a desired specimen volume range. A method of manufacturing a collection container having an integral fill-line indicator is also disclosed.

Abstract: A needle shield assembly and method of manufacturing a needle shield are provided. The needle shield assembly includes a needle hub having a needle cannula extending therefrom. A needle shield base is pivotably coupled to the needle hub. A locking assembly including a needle engagement member is coupled to the needle shield base. One or both of the needle shield base and the locking assembly include a cavity for receiving the needle cannula. The needle shield is manufactured by providing a needle shield base and a separate locking assembly including a needle engagement member, and connecting the locking assembly to the distal end portion of the needle shield base.

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. The shield includes a clip with a plurality of cannula finger locks for preventing re-exposure of the used needle.

Abstract: A device for delivering a substance into the skin of a patient includes a body and a skin penetrating device having at least one skin penetrating member, such as a microneedle. The body includes an internal cavity and a device for indicating the delivery of a sufficient amount of the substance to the patient and for producing a dispensing pressure to dispense and deliver the substance from the cavity. The indicating device is visible from the exterior of the delivery device. In some embodiments, the indicating device is an elastic expandable diaphragm which, when the cavity is filled with a substance, creates the dispensing pressure.

Abstract: A needle assembly includes a needle and a hub mounted to each other. The hub includes a sidewall spaced outwardly from the needle cannula and extending to a distal position between the opposed ends of the needle cannula. A housing integral with the hub defines a sidewall to partially confine a safety shield. The safety shield is slidably disposed about the needle cannula and releasably retained in a proximal position and can be moved to a distal position where the safety shield completely surrounds that portion of the needle hub projecting distally from the hub. The needle assembly includes a spring for propelling the safety shield to the distal position and a latch for releasing the safety shield from the proximal position. The latch may be passively activated by normal usage of the medical implement to which the needle assembly is mounted or alternately activated manually.

Abstract: A device for delivering a substance into the skin of a patient includes a body and a skin penetrating device having at least one skin penetrating member, such as a microneedle. The body includes an internal cavity and a device for indicating the delivery of a sufficient amount of the substance to the patient and for producing a dispensing pressure to dispense and deliver the substance from the cavity. The indicating device is visible from the exterior of the delivery device. In some embodiments, the indicating device is an elastic expandable diaphragm which, when the cavity is filled with a substance, creates the dispensing pressure.

Abstract: The present invention is directed to a shieldable blood collection set and a needle assembly for use therewith. The needle assembly includes a needle cannula having a puncture tip at a distal end, a hub which supports the needle cannula, and a shield. The hub and the shield are axially movable with respect to each other between a first sampling position, where the puncture tip is exposed from the shield, and a second shielded position where the shield covers the puncture tip. A gauze pad is connected to the shield through a tether. After a venipuncture procedure, the gauze is maintained over the needle puncture tip at the puncture site, and the needle is withdrawn from the patient by pulling on the hub. This movement causes the tether to tightly extend between the gauze and the shield, which causes the needle puncture tip to be withdrawn into the shield.

Abstract: A blood collection device includes a needle hub with a flashback chamber and a vent plug covering the flashback chamber. The vent plug permits a flow of air across the vent plug but prevents a flow of liquid across the vent plug. An intravenous cannula is mounted to the hub and extends into the flashback chamber. A non-patient cannula is mounted to the hub and also extends into communication with the flashback chamber. A passive shielding device is mounted to the hub and can be moved from a proximal position where the intravenous cannula is exposed to a distal position where the intravenous cannula is partly shielded. The flashback chamber can be observed to provide an early indication of venous access. A fluid collection tube then can be placed in communication with the non-patient needle and can simultaneously trigger movement of the safety shield.

Abstract: A medical device for delivering a medicament to a patient includes a syringe assembly having a syringe barrel, a needle cannula coupled to the syringe barrel, and a plunger having an end connected to a stopper for insertion into an end of the barrel. A shield system is provided for preventing inadvertent needle sticks after use of the syringe. The shield system includes an actuator mounted on the syringe barrel and movable from an initial position to a retracted position in response to the application of the medicament delivery force. A shield arranged on the front portion of the barrel is responsive to the position of the actuator to deploy the shield from a first position wherein the tip of the needle cannula is exposed, to a second position wherein the shield covers the needle cannula tip.