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 sterile closure assembly for a container or vial includes an elastomeric closure for sealing the open top of a 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. A washer is secured in surface contact with the top surface of the closure. The washer defines an opening that delimits an access area on the top surface of the closure for access by a fluid delivery device such as a syringe. A membrane is removably secured over the washer and hermetically encloses the access area of the elastomeric closure. The sterile closure assembly can be provided pre-assembled in a sterile state to assure the sterility of the top surface of the closure, obviating the need to sterilize the top surface of the closure, such as with an alcohol solution, prior to use of the vial.

Abstract: The syringe for medicinal purposes features a syringe barrel (1), one end of which is formed as an adapter (2) for a cannula or a closure (3), e.g., in the form of a tip cap, and of a plunger (4), arranged within the syringe barrel (1), and movable by a piston rod (5). At the end of the syringe barrel (1) facing away from the adapter (2), a plunger brake (6) is arranged, which is formed by a rest piece surrounding the syringe barrel (1) and connected removably to it. The rest piece has a projection extending into the lumen of the syringe barrel (1), which forms a stop for the side of the plunger (4) away from the adapter (2).

Abstract: The user activated iontophoretic device of the present invention includes a disposable patch and a reusable controller. The patch contains an electrode assembly, an electrode reservoir and at least one drug reservoir. The patch is divided or otherwise separated into at least two portions, with one portion containing the electrode reservoir and the other containing the drug reservoir, which may include a medication in a dry form. The electrode reservoir and the drug reservoir are sealingly separated by a barrier, which can be manipulated to bring the reservoirs into fluid conducting contact with one another. A method of activating the device includes causing the two portions to rotate about a central axis relative to one another to manipulate the barrier and bring the reservoirs into fluid conducting contact with one another to at least partially hydrate one of the reservoirs. In this way, the device is suitable for use to deliver a drug which has limited stability in an aqueous solution.

Abstract: A syringe stopper for use in a syringe barrel having a substantially cylindrical body comprises a piston-like stopper body for slidable fluid-tight engagement inside the barrel of the syringe. The body includes a distal end, a proximal end and a longitudinal axis therethrough. A distally directed, conically-shaped projection is positioned on the distal end of the stopper body. At least one elongate discontinuity, running along the conically-shaped projection, is provided. The discontinuity includes a first end on the conically-shaped projection and extends radially outwardly therefrom to a second end, as viewed from the distal end of the stopper. The discontinuity may be in the form of a raised rib or a recessed groove.

Abstract: An iontophoretic drug delivery system of the present invention includes a multiple-pod housing, a controller, a power source and an electrode assembly in electrical contact with at least two reservoirs, with at least one of the reservoirs containing an active formulation to be delivered to an applied area of a patient. In the preferred embodiment, the housing includes three pods to more easily conform to the contours of the body, with two pods each including reservoirs and the electrode assembly, and the other pod including the controller.

Abstract: This invention relates to a method for autoclustering N-dimensional datastreams. The invention has particular utility in analyzing multi-parameter data from a flow cytometer, and more particularly has utility in analyzing data from whole blood cells tagged with fluorescently labelled CD3, CD4 and CD8 monoclonal antibodies to which a known number of fluorescent microbeads has been added.

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 and a stopper sleeve, both slidably mounted in the open top of the vial. The connector assembly includes a stopper affixed to the stopper sleeve and sealingly engaged in the open top of the vial. The stopper is slidably moveable in response to axial movement of the stopper sleeve. Movement of the stopper sleeve 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, stopper sleeve and stopper after the stopper has been moved into the opened position in the vial. Movement of the spike, stopper sleeve and stopper 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: A hypodermic needle featuring a multi-beveled point geometry is disclosed. In one embodiment, the multi-beveled point features a primary bevel, a pair of tip bevels, and a pair of middle bevels each intermediate the primary bevel and a respective one of the tip bevels. The primary and middle bevels are provided at angles of inclination, measured between the central axis and a reference plane that are substantially identical. The tip bevels are formed at an angle of inclination respective to the central axis which is not equal to the angle of inclination at which the primary and middle bevels are formed. The resulting five-beveled point geometry contributes to a more continuous bevel face free of abrupt intercepts or transitions between the respective bevel faces, lessening the penetration force required to urge the needle point through skin, flesh, or other material.

Abstract: A syringe assembly includes a substantially cylindrical syringe barrel and a plunger stopper. Distal portions on the plunger stopper are configured to permit outflow of vapor from the syringe barrel during a lyophilization process. Proximal portions of the plunger stopper are dimensioned to engage the syringe barrel in sliding fluid-tight engagement. Liquid medication in the chamber is lyophilized and a vacuum is applied to the syringe barrel after lyophilization. The plunger stopper then is urged distally into sealing engagement with the syringe barrel. A plunger rod can be engaged with the plunger stopper. The tip cap is then removed and a diluent is drawn into the chamber by moving the plunger rod and the plunger stopper in a proximal direction. The syringe assembly then can be used in the standard manner.

Abstract: A user activated iontophoretic device of the present invention includes an electrode assembly, an electrode reservoir and at least one drug reservoir. The device is divided or otherwise separated into at least two portions, with one portion containing the electrode reservoir and the other containing the drug reservoir, which may include a medication in a dry form. The electrode reservoir and the drug reservoir are sealingly separated by a barrier, which can be removed to bring the reservoirs into fluid conducting contact with one another. A method of activating the device includes causing the two portions to come into fluid conducting contact with one another to at least partially hydrate one of the reservoirs. This can be accomplished by removing the barrier dividing the two portions. In this way, the device is suitable for use to deliver a drug which has limited stability in an aqueous solution.

Abstract: This invention provides a method of multi-parameter data analysis by means of a hierarchical attractor algorithmic engine. The method employs analyzing the data by construction of a population hierarchy, wherein the populations are not mutually exclusive, thereby providing an important analytical tool. The use of the hierarchical attractor algorithmic engine presents the user with far greater flexibility in such analysis, as overlapping populations can be separately examined.

Abstract: An iontophoretic drug delivery system including a patch, a controller and a magazine. The patch may be secured in a compartment formed in the magazine so that upon insertion of the controller along the magazine to fasten the controller to the patch, a dry drug contained in the patch is hydrated and the patch and controller can be removed from the magazine for attachment to the skin of a patient.

Abstract: A droplet-deflection flow sorter images a series of droplets, analyzes the image to determine droplet spacing, and alters flow velocity to achieve a desired spacing. Cells in a suspension are forced by gas pressure into a narrow conduit to serialize them and then out a nozzle that includes a "window" that allows cells of interest to be characterized. Droplets breaking off from the exiting jet are imaged by a video system including a strobed light source and a video camera. Droplet spacing is determined by locating the centers of gravity of the droplets. The centers of gravity are located by processing the droplet images to produce line segments corresponding to volumetric droplet slices, with the relative volumes of the slices being proportional to the squares of the line segment lengths. This approach determines droplet center positions and thus spacing more accurately than non-imaging methods, especially with aspherical droplets and droplets with satellites.

Abstract: An iontophoretic drug delivery system including a patch and a controller. The controller and patch include electronics which ensure proper hydration of the patch. If the controller determines that the patch is sufficiently hydrated, the controller applies current to the patch for delivery of the drug through the skin of the patient.

Abstract: An iontophoretic system includes a medicament containing disposable patch removably attached to a patient's skin in combination with a controller mechanism. The patch includes an anode and a cathode, and holds an electrolyte and a medicament. The controller includes a controller circuit which is coupled to the cathode and is adjustable to provide a desired current flow through the electrodes to drive the medicament to the skin of the patient. The controller preferably includes a variety of functions to ensure safe and proper delivery of the medicament. The controller circuit is preferably an application specific integrated circuit (ASIC) so as to provide a compact controller having increased reliability and reduced power consumption.

Abstract: An iontophoretic delivery system permits transcutaneous delivery of a drug contained on a patch. The system includes a flexible planar patch having a medicament-containing surface in contact with the skin of a patient. A controller supplies electrical current to effect iontophoretic delivery. Electrical connection is established between the controller and the patch. The connection is maintained free of contaminants which could adversely affect the electrical connection by employing an abrasive wiping surface to clean the electrical interconnection.

Abstract: A method for forming and packaging an iontophoretic patch in an inert atmosphere to provide increased shelf-life. The method includes a number of sub-assemblies for forming a well in a laminate material, forming the reservoir and dosing the reservoir, sealing the laminate material and another laminate material together to form a continuous web from which the individual patches are cut. In addition, the patch can be subsequently enclosed in an individual package. In this way, the patch and/or package provides a commercially suitable shelf-life to the drug-filled patch stored therein.

Abstract: A flow cytometry system includes a flow tube through which particles marked with different fluorochromes pass from a first location, illuminated by a red laser, to a second location, illuminated by a blue laser. A "red" photodetector is optically coupled to detect red fluorescence from both locations. "Yellow" and "green" photodetectors respectively detect yellow and green fluorescence from the second location, while a "scattered light" detector detects scattered light from the second location. During a sample run, the red photodetector can output pulses that correspond primarily to APC fluorochrome at the first location and to PerCP at the second location respectively. A delay device delays the APC pulse relative to the PerCP pulse so that the peaks can be scaled and subtracted in the analog electrical domain to remove APC/PerCP crosstalk. The delay is calibrated using a set of APC tagged cells.

Abstract: An iontophoretic drug delivery device including a reusable controller and patch are disclosed. The controller and patch include electronics which ensure compatibility of the reusable iontophoretic controller with the specific patch to which it is connected. If the controller determines that the patch is incompatible with the controller, the controller does not apply current to the patch.