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 two chamber container for the separate storage and selective mixing of two components is disclosed. The container includes two outer flexible thermoplastic sheets and an inner, diaphragm sheet. A unique seal line structure is formed between one of the outer sheets and the inner, diaphragm sheet. A peelable barrier structure such as a sheet of aluminum foil with an inner layer of adhesive is secured to the exterior surface of the exterior wall of the container at that portion of the other of the outer sheets which defines one of the chambers of the container. The peelable barrier sheet permits the use of lower cost materials for the remainder of the container structure while both (1) permitting visual inspection of the chamber contents and (2) providing high moisture, gas and light barrier properties.

Abstract: A unitary, thermoformed container having an undercut or re-entrant seal flange is provided. The container is made in a molding method and apparatus in which a flange-forming portion thereof has a short-stroke gate assembly that opens after the unitary, thermoformed container has been formed in order to provide an exit path away from the molding cavity to permit ready removal of the thermoformed container out of the molding cavity and its flange-forming portion.

Abstract: A container adapted for the mixing of a liquid and a solid initially placed in separate compartments. The compartment containing the solid has two access ports so liquid can pass through the compartment carrying the solid with it for better mixing.

Abstract: A container which includes body, neck and cover portions of one-piece plastic construction and a line of weakness defined between the neck and cover portions to permit selective separation of the cover from the neck, further includes an inner closure carried by and removable with the cover portion to prevent spillage of the container contents upon opening of the container. The inner closure is disposed to seal the neck below the line of weakness to isolate the contents of the container from the area of the line of weakness. When the container is heat sterilized, means is provided associated with the chamber defined by the cover and closure to prevent collapse of the cover during the post heat-sterilization cooling cycle. The associated means includes structure to provide moist air in the defined chamber during heating of the container without endangering the sterility of the container contents or nullifying the advantage of the inner closure.

Abstract: A cooling system is provided for organs during transplant surgery. A disposable receptacle (10) has a sterilizable interior and is formed of a material that is sufficiently rigid to maintain its shape normally without collapsing but sufficiently flexible to be squeezable manually. A disposable flexible container (16) is located inside the receptacle. The flexible container (16) contains a liquid solution that is adapted to be chilled in a freezer. The flexible container (16) and its contents are sterilizable and useful for providing cooling for organs during surgical transplants. The disposable receptacle (10) has a peelable lid (14) that is sealed to a tray portion (12) to enable the sterilizable container (16) to be aseptically removed from the receptacle (10).

Abstract: Provided is a process for preparing an aseptic container for separately storing a sterilized powdered component and a sterilized liquid component under clean conditions. The container includes two sealed chambers having a frangible, sterilized connection therebetween, one said chamber containing the liquid component, and the other said chamber including a sealed vial containing a powdered component. The vial has an outer surface that is aseptic throughout its entire surface area, and the frangible connection provides a sterile pathway, when desired, between the interior of the vial and the interior of the liquid-containing chamber.

Abstract: Apparatus for selectively mixing two components such as a powder and a liquid in a quick and efficient manner. The apparatus includes a compressible chamber with a liquid component therein, the compressible chamber including gas-trapping and reservoir compartments in open communication. Included is an arrangement to access the gas-trapping compartment such that the chamber may be connected to a container having a mixing component such as a powder therein so as to form a selectively opened pathway between the container and the compressible chamber of the apparatus. The apparatus may include the container. After the pathway is opened, the gas-trapping and reservoir compartments are selectively positioned to facilitate proper mixing of the liquid component in the chamber with the component in the container.

Abstract: A luer connection system is provided in which a male luer connector (20) has a main body portion (22) and a front luer portion (24) with a locking ring (42) that is axially slidable along the main body portion (22). The locking ring (42) is adapted to threadedly engage a mating female luer device (52). A collar (26) is carried by the male luer connector (20) between the main body portion (22) and the front luer portion (24). The luer connector has a flexible member (38) which flexes to a stressed position when the locking ring (42) is in threaded engagement with the mating female luer device (52). In this manner, there is some stress provided in the threaded engagement to prevent the locking ring (42) from inadvertently disengaging.

Abstract: There is disclosed herein an improved hermetically sealed container and closure assembly for storing and dispensing sterile liquids. The container includes a bottle having a neck which defines an outlet or mouth, a set of external threads adjacent the outlet and transverse abutment shoulder means on said neck and spaced from the outlet. The closure includes an externally threaded cup-shaped overcap having a generally cylindrically-shaped side wall, a top wall for positioning across the bottle mouth and wiper means depending from said top wall for sealing in cooperation with said outlet. The overcap is hermetically bonded to the bottle neck. An outer jacking ring is provided which is threadedly interfitted over the overcap and adapted for counterclockwise rotation to engage the abutment means and cause the overcap to move axially upwardly from the bottle outlet.Ramp-like cam means are provided on the neck for cooperation in sealing the wiper means to the bottle outlet.

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.