Abstract: An apparatus and method for creating the transverse seals in a form, fill and seal packaging machine is provided. The apparatus includes a heating member that heats a portion of the web of film to create the transverse seals, and a cooling member that cools the heated portion of the web of film and the heating member. The heating member includes a hot bar, a heater for heating the hot bar, and a biasing member that disengages the hot bar from the heater before the hot bar contacts the web of film.

Abstract: An artifical nipple is disclosed which is interactive with an infant to provide a stimulus/response operation. The nipple portion has a generally cylindrically shaped, but undulated deformable outer wall closed at one end and a resilient elongated member disposed interior of the outer wall, depending from the closed end. The elongated member is spaced from the interior of the outer wall to define an annular chamber such that an infant will meet two levels of resistance to lateral compression of the nipple and a plurality of dispensing apertures provided communicating with said annular chamber, so that fluid flows through certain of said apertures in a manner responsive to infant suckling action.A nursing container utilizes the artificial nipple and a flexible fluid container is sealed to the nipple portion along a tapered shoulder.

Abstract: A port and closure for a container is provided. The closure includes an interface layer for bonding the closure to the port. The bond strength of the interface layer to the closure is less than the bond strength of the interface layer to the port. The closure being removed from the port by delaminating the interface layer from the port.

Abstract: A reconstitution device for constituting a drug in a standard drug vial with a liquid in a second container such as a parenteral solution container is provided. The reconstitution device 10 includes a housing 52 and a hollow, double-pointed needle 54 mounted within the housing. The housing includes a sheath 70 having a substantially circular base 72 and a skirt 74 depending from the base. The skirt 72 includes a free end 76, a substantially cylindrical inner surface 78 and an outer surface 80. A plurality of inwardly projecting bumps 82 are intermittently spaced about the inner surface 78. The bumps are disposed a substantially equal distance from the base 72, the distance being substantially equal to the width of the malleable band.

Abstract: An apparatus for shaping a web of film with attached fitments into a tubular shape. The apparatus including a plate member including a cut-out portion and an oblong member. The plate member and oblong member defining a channel and cooperating to fold a web of film with attached fitments into a substantially tubular shape.

Abstract: A sealing closure for a male Luer fitment includes a rigid hollow cap and flange means for a pressure lock with the fitment. The sealing closure includes a compressively retained elastomeric insert which deforms over time to compensate for creep between the fitment and the hollow cap. The sealing closure provides a liquid-tight seal over time against a pressurized liquid supply in open communication with the fitment.

Abstract: A cannula assembly especially for medical use is disclosed which virtually eliminates coring during the piercing of a barrier. The cannula assembly includes a hollow cylindrical shank and a piercing tip removably mounted in and closing one end of the shank. Pressurized introduction of fluid through the shank forces the piercing tip out of engagement with the shank, placing opposite sides of the barrier in fluid communication.

Abstract: A sterile, closed drug delivery system (10) is provided comprising a flexible container (12), a capsule (22) coupled to the flexible container and a standard glass drug vial (36) positioned within the capsule. The flexible container has a liquid diluent therein. The capsule has supporting legs (32-35) which extend inwardly from the capsule to support the vial and also a highly flexible, pleated cap (28) which enables the drug vial to be manually moved relative to the supporting legs. The capsule is coupled to the flexible container by means of a hollow spike (54) located within the capsule and a frangible member (58) located within the flexible container, which frangible member allows fluid passage only when it is broken. Manual pressing of the pleated cap moves the drug vial downwardly onto the spike, piercing the stopper of the drug vial. Once the frangible member is broken, there is sterile communication between the drug vial and the liquid diluent contents of the flexible container.

Abstract: A container is disclosed for maintaining its contents at a desired temperature for an extended period of time such as for use in shipping contents in a frozen condition. The container includes an outer shell which is substantially airtight and which has an inner surface; a passive heat exchange medium; a support structure for the heat exchange medium; and means for maintaining an air space between the contents of the container and substantially the entire inner surface of the outer shell of the container and between the contents of the container and the support structure for the heat exchange medium for allowing convection current to develop in the air space which circulates past the heat exchange medium and maintains a substantially uniform temperature around the contents of the container.

Abstract: An in-line set filter for parenteral solution sets and the like which comprises a tubular housing having first and second ends. A bundle of filter tubes is positioned within the housing, the filter tubes preferably being folded so that all ends of the filter tubes occupy a single zone in communication with the first housing end. The zone is filled with potting compound with the filter tube ends communicating through the potting compound and open to the exterior. A flow access port is laterally positioned in a side wall between the second end and the potting compound but closer to the potting compound. The second end defines an open aperture occluded by a porous hydrophobic filter to permit venting while preventing loss of aqueous liquid.

Abstract: A drip chamber assembly is provided which includes a chamber that is flexible but is non-collapsible under a negative pressure condition. The chamber, being flexible, yields to priming easily, but when restriction is added to the inlet port the chamber will not collapse and aspirate air to the patient. A flexible chamber is formed of a vinyl plastic material having a thickness of about 0.04 inch to 0.08 inch and a durometer reading of about 61 shore A to 81 shore A. End caps rigidly support each of the ends of the chamber with the end caps each having a contact length along the chamber of at least 0.2 inch.

Abstract: A method is disclosed for forming, filling and hermetically sealing a blowmolded container having a sterile integral inner dispensing outlet, all in a single sterile operation. The method is directed toward establishing a preferably hermetic seal between the inner dispensing outlet and the container neck, by establishing the seal early in the blowmolding cycle. This is accomplished by mounting the dispensing outlet-defining tubular member about a unique fluid supply mandrel. The supply mandrel thereby also serves as a check and the tubular member of the to-be-formed container serves as a tool in blowmolding. The dispensing outlet/container neck seal is thus formed before the blowmolding step.

Abstract: A generally non-transparent substrate is rendered substantially transparent, for example at a particular location or locations thereon, by electrostatically depositing finely divided transparentizing particles onto the substrate and then heating those particles to facilitate their flow into the intersticies of the substrate. The transparentizing particles have an optical refractive index that is substantially the same as that of the substrate, and these transparentizing particles have a melting point greater than that encountered during handling and storage and less than the temperature at which the substrate would be damaged.

Abstract: In a parenteral solution administration set, the porous hydrophilic filter member which can control the liquid level and prevent the passage of gas downwardly through the set can be located adjacent the lower end of the drip chamber to control flow out of the lower end and to be submerged in liquid held in the drip chamber during operation thereof. Significant advantages are obtained. Particularly, the set becomes conveniently usable with parenteral solution pumps. Also the drip chamber may contain an elongated member projecting inwardly of the lower end of the chamber and carrying indicia along its length to indicate liquid volume in the chamber as a function of liquid level.

Abstract: A unique container is disclosed which has at least three chambers for the separate storage and selective mixing of at least two components. The container includes two outer flexible sheets and an inner, diaphragm sheet, all sealed about their peripheries in the preferred embodiment. Multiple breakable lines of securement are formed between one of the outer sheets and the inner, diaphragm sheet. Multiple permanent lines of securement are formed between the inner diaphragm sheet and the other outer sheet, extending substantially parallel to and substantially the length of the respective breakable lines of securement. Such a container structure defines two chambers which have no common boundary and an intermediate chamber. In the preferred embodiment of the invention, the intermediate chamber does not store any substance; rather, it serves as a buffer or barrier chamber and also acts as a test for seal integrity. In another embodiment of the invention, the intermediate chamber holds a third component for mixing.

Abstract: A one-piece integral plastic container is disclosed which has an outer closure or overcap removable along a frangible line of weakness, and a separately-formed inner closure that is maintained in sterile condition by the outer closure until the container contents are dispensed. The inner closure comprises a tubular member inserted in fluid-tight relationship within the container neck after the container body and neck are molded, but prior to formation of the outer closure. The tubular member thus provides the dispensing outlet for the container and is maintained in sterile condition by the overcap which encloses it.

Abstract: A container (34) includes first and second chambers (40, 42) for the storage of two substances (44, 46) such as medical liquids. The chambers are separated by a chamber-communicating assembly (61) which is selectively opened by an operator for mixture of the two substances and delivery to a patient. A leak detection compartment (62) encloses the assembly (61) between the two chambers, including a periperhal channel (76) and ridges (80) on the assembly (61).When seal integrity between the container wall sheets (36, 38) and the assembly (61) is less than complete, the leak detection compartment both prevents liquid in one chamber from entering the other through the leak pathway and also assures detection of the leak during the manufacturing operation.

Abstract: In a fluid administration set of otherwise conventional design, an in-line chamber is provided having an inlet and outlet port communicating with the chamber and defining part of the path of flow through the set. A sealing piston is slidably movable by fluid pressure within the chamber and capable of occupying first positions in which the sealing piston isolates fluid in the chamber adjacent the inlet port from fluid in the chamber adjacent the outlet port. The sealing piston also can occupy at least one second position in which unlimited fluid flow is permitted between the inlet port and outlet port. A third port is provided for intermittently inserting a critical fluid into the chamber on the side of the sealing piston facing the outlet port.

Abstract: A molded collapsible solution container, which is made from a tubular, plastic parison, defines a body portion having an integral neck portion and shoulder portion at one end thereof. The container is sealed at its opposite end. The body portion defines, in as-molded configuration, a generally oval cross-section taken perpendicular to the axis of the container, adjacent the neck and shoulder portion. The cross-section tapers progressively to a flat configuration at the end of the container opposite to the neck and shoulder portion, which facilitates a uniform manner of flat collapsing of the container progressively from the opposite end toward the end adjacent the neck and shoulder portion as the contents thereof are withdrawn through the neck portion, when the container is disposed in neck downward position.