Abstract: A lockable safety shield assembly for a prefillable syringe is provided. The design of the lockable safety shield assembly enhances pharmaceutical manufacturers' ease of assembling the various components as part of its filling or processing of the prefillable syringes in normal practice, while at the same time minimizes difficulties in mating parts made from different materials. A tube is placed around the outside surface of the syringe barrel and affixed thereto. A collar is provided on the tube adjacent the distal end of the syringe barrel. A safety shield is axially slidable over the tube between a retracted position, wherein the distal end of the piercing element associated with the prefillable syringe is exposed, and an extended position, wherein the safety shield is locked to the collar to protectively cover the distal end of the piercing element. The safety shield includes locking structure configured so that the shield can be easily fitted over the tube.

Abstract: A resealable vial featuring a fluid access device having a membrane for selectively opening or sealing a fluid passageway between the bottle and the fluid access device. The vial includes a body disposed on said bottle. The fluid access device can be configured as a spike assembly, a needle assembly, or a luer lock assembly, and features a hollowed rod in sliding, fluid-tight relation to an orifice defined by the body. A membrane, preferably formed from an elastomeric material, is secured across both the orifice and the open top of the bottle, and may be retained between the top surface of the bottle and the body. The membrane preferably includes a central area sealing the orifice from the open top of the bottle, with one or more fluid passages defined on a portion of the membrane outside of the central area.

Abstract: The improved vial transfer assembly or vial transferset may be attached to a vial under sterile conditions and used to transfer fluid to or from a conventional vial. The transferset includes a tubular transfer member which is sealingly supported on the rim portion of a vial stopper, a piercing member having a piercing end reciprocally supported by an internal surface of the transfer member, a cap enclosing the tubular transfer member and a collar preferably formed of a malleable material which secures the assembly on the stopper, which is crimped beneath the vial rim. The piercing member has a generally longitudinal external channel which, upon piercing the planar portion of the stopper, establishes fluid communication with the vial through the tubular transfer member. The distal end of the tubular transfer member includes a Luer lock for establishing fluid communication to a syringe, IV set or the like.

Abstract: An assembly (20) of syringes (22) includes a first layer (32) enclosing the syringes. The first layer maintains the syringes in an orientation where some of the syringes have a first, larger end aligned with the second, smaller end of the remainder of the syringes. The first layer also protects the syringes from outside contaminants. A second layer (34) encloses the first layer and protects it from outside contaminants. The syringes and the first layer preferably are sterilized within the second layer 34.

Abstract: A method and apparatus for attaching a connector assembly onto a vial is disclosed. The connector assembly features a protective cap, a collar attachable to the rim of the vial, and a crimp cap for securing the collar to the rim. A vial access device is contained within the collar. One or more ribs are provided adjacent a distal portion of the collar to seal against the stopper obturating the vial. The collar is provided with one or more slits which render the collar flexible in directions radial and axial to the central axis of the vial to compensate for variations in tolerances or dimensions present in the various components. The crimp cap can be supplied preattached to the collar in an uncrimped condition.

Abstract: An iontophoretic drug delivery system including a plurality of patches, at least one reusable controller and a unit for storing and dispensing the patches. The patches may be secured in a compartment formed in the unit and the controller may be stored in another compartment formed in the unit. In this way, the reusable controller and a new patch can be removed from the unit and fastened to one another for activation and attachment to the skin of a patient.

Abstract: An apparatus and method of delivering drugs from multiple sites on a patients body is provided. A controller is used at each site, and these controllers communicate with each other to coordinate drug delivery from the multiple sites. In a preferred embodiment, the drugs are delivered using iontophoresis.

Abstract: The apparatus includes a combination of a microscope and an interactive image analysis system comprising a camera and a computer work station. The purpose of the apparatus is to facilitate the interactive control of coordinate displacements of the stage of the microscope. For each coordinate x and y an electromechanical control channel is established. At the input of the control channel two cascaded wheels in a coaxial arrangement and two angle encoders are used as a detached, independent tool which is not kinematically linked to the stage. In the middle of the control channel, the pulses of the angle encoders undergo a non-linear transformation. A processor performs a calculation which discriminates between slow displacements and fast displacements. At the end of the control channel, a flat, easily accessible platform of the microscope stage has two working areas, one for manual previewing and one for interactive scanning of a specimen.

Abstract: A multi-laser flow-cytometry system provides for inter-location emissions crosstalk cancellation, through either pulse subtraction or gating, to avoid false triggering based on shadow (pre- and post-) pulses that occur when red-excited red emissions are detected by a photodetector arranged to detect blue-excited red emissions. This overcomes a problem of undercounting of counting beads that led to misdeterminations of cell counts when blue-excited red fluorescence detections were used as a trigger. The approach also provides for more accurate quantitative data regarding fluorochrome emissions amplitudes.

Abstract: A connector assembly is provided for efficient flow of liquid into and/or out of a vial, such as a vial containing a lyophilized drug. The connector assembly includes a spike slidably mounted in the open top of the vial. The connector assembly further includes a stopper sealingly engaged in the open top of the vial and slidably moveable in response to the axially movement of the spike. Thus, movement of the spike relative to the vial will move the stopper into or out of sealing engagement with the vial. The connector assembly further includes a spring for generating a small amount of axial movement of the spike after the stopper has been moved into the opened position in the vial. Movement of the spike generated by the spring will cause a sufficient change in pressure to overcome surface tension and initiate an efficient flow of fluid into or out of the vial.

Abstract: An iontophoretic system including a controller and a patch is provided. The controller has a receiving portion including an upper surface and a lower surface, and a member protruding from the lower surface in a ramp-like fashion toward the upper surface and terminating in a top edge near the upper surface. The patch has an interconnection tab including an opening for engaging the protruding member of the controller when the interconnection tab is inserted into the receiving portion of the controller and the opening falls over the top edge of the protruding member.

Abstract: A resealable transfer assembly for a container such as a bottle or vial featuring a membrane for selectively opening or sealing a fluid path between the bottle and a medical delivery device introduced into the assembly. The assembly includes a body disposed on the bottle, and a luer connector hub which may be separately provided with the body or formed integrally therewith. A free plug rests in a cavity defined within the luer connector hub. The free plug includes an orifice dimensioned to accept a luer tip associated with the medical delivery device. A membrane, preferably formed from an elastomeric material, is secured across both the opposed end of the luer connector hub and the open top of the bottle, and may be retained between the top surface of the bottle and the body. The membrane preferably includes a central area sealing the opposed end of the luer connector hub from the open top of the bottle, with one or more fluid openings defined on a portion of the membrane outside of the central area.

Abstract: A stopper assembly having by-pass features for use in a multi-chamber syringe barrel. The stopper assembly includes a sequential stopper body responsive to fluid forces for enabling the sequential delivery of disparate contents, such as disparate fluids, separately held in the syringe barrel. The sequential stopper body has a generally cylindrical sidewall with a distal end, a proximal end and a longitudinal axis therethrough. The stopper assembly also includes a generally cylindrical flow channelizer mounted to the distal end of the sequential stopper body. The flow channelizer enables the reconstitution of dry medicament held in the syringe barrel distally of the flow channelizer. The flow channelizer features opposed proximal and distal ends and a generally cylindrical outer surface therebetween. At least one fluid flow channel extends between the proximal and distal ends of a flow channelizer.

Abstract: An iontophoretic drug delivery device includes a controller normally being in an off or low power consumption state, and a patch including electrodes, a reservoir containing an ionizable drug for transcutaneous delivery to a patient and a return reservoir. The patch is removably and electrically connectable to the controller, and delivers the drug to patient when the patch is on the patient's skin and when the controller is switched from the off or low power consumption state to an operational state. This occurs when the patch is inserted into the controller. This feature preserves the battery of the controller. Upon patch insertion, the controller periodically changes from a non-current delivery state to a current delivery state for the predetermined period of time to deliver a pulse of current to the inserted patch. A current sensor within the controller measures the current delivered to the patch.

Abstract: A bottle having a sterility seal and a method for producing same are disclosed. The bottle, which can be configured to retain a medicament in powder or tablet form, features a protective cap configured to engage a transfer assembly associated with the bottle. The cap includes one or more raised ridges on an interior surface engageable with a portion of the transfer assembly. A band or layer configuration of a sealing material such as silicone is applied to the transfer assembly prior to insertion of the cap thereover. As the cap comes into surface contact with the sealing material, the ridges cause the material to "roll up" into a toroidal O-ring configuration, thereby forming a seal between the cap and the bottle adapted to the dimensional variations of those components.

Abstract: A device for automatically injecting a material into the body is disclosed. The device includes a drive assembly and a disposable assembly including a syringe which is mounted to the drive assembly. The drive assembly includes a drive rod, a driver releasably coupled to the drive rod, and a spring which urges the drive rod towards the syringe assembly. The spring first urges the coupled drive rod and driver along the axis of the device, causing the skin to be penetrated by the needle of the syringe assembly. The drive rod is then decoupled from the driver. The spring continues to urge the drive rod in the axial direction, whereby the drive rod engages a piston in the syringe assembly and causes the displacement of the material therein. A cap is removably mounted to the disposable assembly. Locking members on the cap and disposable assembly prevent removal of the cap until the disposable assembly is moved to the firing position within the drive assembly.

Abstract: An iontophoretic drug delivery system of the present invention includes a disposable patch electrically interconnectible with a controller. The patch includes at least two electrode assemblies, with one of the electrode assemblies having a first electrode and a second electrode. In this way, during delivery of electrical current one of the electrodes is exhausted so that upon an attempt to reuse the patch, the controller does not detect the delivery of electrical current through said electrodes and fails to supply electrical current to the electrode assemblies for delivery of the drug. Electrical interconnection between the patch and the controller is established by inserting a tab extending from the patch into the controller.

Abstract: The apparatus includes a combination of a microscope and an interactive image analysis system comprising a camera and a computer work station. The purpose of the apparatus is to facilitate the interactive control of coordinate displacements of the stage of the microscope. For each coordinate x and y an electromechanical control channel is established. At the input of the control channel two cascaded wheels in a coaxial arrangement and two angle encoders are used as a detached, independent tool which is not kinematically linked to the stage. In the middle of the control channel, the pulses of the angle encoders undergo a non-linear transformation. A processor performs a calculation which discriminates between slow displacements and fast displacements. At the end of the control channel, a flat, easily accessible platform of the microscope stage has two working areas, one for manual previewing and one for interactive scanning of a specimen.

Abstract: A protective sealing barrier for a syringe is disclosed. The protective sealing barrier can be configured to safeguard the sterility of the syringe and any contents held therein, as a barrier against leakage of any contents held within the syringe, or both. The syringe includes a luer tip and a collar having terminal ends which are preferably substantially co-planar with one another. The barrier consists of a membrane which is disposed in substantially entire surface contact with the terminal ends of both the luer tip and the collar. The membrane can be selected from a material permitting the syringe to be irradiated or heat sterilized. Likewise, the membrane can be chosen from a material permitting the syringe to be sterilized by various gas sterilization procedures.

Abstract: A lyophilization closure assembly for a container or vial is disclosed. The lyophilization closure assembly is self-supporting with the container and may be employed with the container during a lyophilization process, eliminating the need for a separate crimping operation outside of the sterile environment in which lyophilization is conducted. The lyophilization closure assembly includes a body with a skirt disposed around the rim of the container. The skirt features one or more deflectable abutments and one or more deflectable latches positionable about the rim of the container, and defines one or more vapor passages. An elastomeric closure is retained within the body for sealing the open top of the medicament container. The elastomeric closure features a plug for sealing the open top of the container and a top surface facing away from the open top of the container. The body defines an opening over the elastomeric closure that delimits an access area on the top surface of the closure.