Abstract: A plastic composition is disclosed which has particular application in the manufacture of blood bags and other medical products. The composition has anti-hemolytic effects when used in the storage of red blood cells. In connection with one aspect of the present invention, the plastic composition comprises the combination of a non-PVC plastic and a selected quantity citrate ester sufficient to suppress hemolysis of red blood cells. The non-PVC material is preferably a polyolefin copolymer. Materials other than citrate ester may also be used with polyolefin as a hemolysis suppressant.

Abstract: Methods are disclosed for sterilizing a selected portion of a product and for assembling a sterile product from two or more parts which can not be sterilized with the same form of sterilization. A sterile product produced by these methods is also disclosed. The method for sterilizing may include sterilizing a selected portion of the product by exposing the selected portion to an electron beam, while shielding the remainder of the product from the radiation of the electron beam. The method of assembling a sterile product from two or more component parts may include the steps of sterilizing the first part of the product, isolating a portion of the first part from the remainder of the first part, attaching the second part to the isolated portion of the first part, and exposing the isolated portion to a form of sterilization which is deleterious to the remainder of the first part, while shielding the remainder of the first part from such form of sterilization.

Abstract: Disclosed is an improved apparatus and method for collecting, freezing and removing a liquid such as blood or blood components, and particularly blood plasma. In accordance with the present invention, a container (16) for blood plasma is defined by a pair of substantially flat, flexible opposing sidewalls (40, 42) which are substantially adjacent when the container is empty. The sidewalls are peripherally sealed together to define an interior compartment, and the side seals (44, 46) converge toward one end (48) of the container. After a selected quantity of plasma is collected in the container, the filled container is formed and frozen in a wedge-shaped configuration, with the opposed sidewalls (40,42) converging toward the end of the container. An air space (82) may be provided in the top of the container so that a knife (86) may be easily inserted into the frozen container without contacting the frozen liquid (88) therein.

Abstract: A mass transfer device (60) includes a hollow fiber bundle (10) comprising a generally cylindrical core (14) having opposed ends, a plurality of layers of hollow fiber (12) that have been wound around the core, and binding means (48a, 48b, 48c), such as double-sided pressure-sensitive tape that have been wound around the layers of hollow fiber in a plurality of longitudinally spaced locations along the core and intermediate the opposite ends of the core for providing longitudinally spaced support means for the hollow fiber bundle. The hollow fiber bundle is enclosed in a housing (62) having an inner wall (80) which defines a generally circular opening for receiving the hollow fiber bundle except that the inner wall adjust a fluid outlet manifold (74) includes an expansion volume (82) for the hollow fibers that are adjacent that fluid outlet manifold. A screen (88) is provided adjacent the fluid outlet manifold to prevent the fibers from migrating too far into the outlet and to provide a controlled expansion.

Abstract: A plastic container and a three-piece closure system therefor are disclosed. The container has a threaded neck defining a dispensing outlet. A separate closure covers the dispensing outlet and is heat-sealed to the threaded neck, forming a frangible section which may be broken to remove the closure. An internally threaded jacking ring is threadedly received on the neck, and includes a plurality of inwardly directed flexible fingers, which snap into an annular groove in the closure when the jacking ring is threaded onto the neck. To break the frangible portion and open the container, the jacking ring is rotated in the direction to remove it, so that the jacking ring fingers press against the top edge of the recess in the closure and actually pry the closure away from the container neck.

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: Apparatus and method are disclosed for quickly, efficiently and with minimum human contact removing the contents of flexible or collapsible containers, for example, frozen blood from the plastic pouches in which it is collected from human donors. The container is positioned and retained between a pair of plates which are relatively movable to compress the container to discharge the contents. The plates are preferably mounted on a continuous conveyor for automatically moving the container from a loading station where the container is inserted between the plates, to an opening area where a portion of the container is removed to provide access to the contents, and from there to a compression position where the plates are forced together to discharge the contents from the container through the access opening. For frozen contents, the plates and container may also pass through a thawing area where the container is heated sufficiently to free it from the frozen contents.

Abstract: In a potted-type seal for sealing an opening in a relatively rigid housing stress-relief means is provided to prevent excessive shrinkage-induced stress between the compound and the housing. The stress relief means includes a relatively flexible peripheral lip portion as part of the housing or, preferably, as part of the potting compound, which lip portion flexes when the potting compound shrinks to reduce stress between the compound and the housing.

Abstract: In an intravenous fluid administration assembly, there is provided a suspended, fluid holding container having a stopper closing off its mouth, a conduit having a hollow spike inserted into the stopper for gravity flow delivery of fluid from the container to the conduit, and a clamp for preventing the unintentional separation of the spike from the stopper. The clamp has a first portion having an opening through which the container's neck extends downwardly and a second portion having an opening through which the spike extends upwardly. The first portion seats on an abutment on the container's neck and the second portion seats under a flange extending outwardly from the spike. First ends of the first and second portions are connected by a third portion of the clamp and the openings in the first and second portions extend to those portions' other free ends.

Abstract: A non-collapsible medical fluid container is disclosed, with microporous filter means mounted on the interior end of a vent conduit that extends into the container for venting displacement air thereinto. The filter means, preferably a rigid microporous depth-type filter frictionally mounted on the end of the vent conduit, is mounted closely adjacent to an interior surface of the container to prevent dislodgement of the filter by pressure from the venting air.

Abstract: A container and hanger therefor are disclosed, wherein the container has a bottom wall portion with a recessed or indented area in which support shaft means are located. An elongated hanger element has an aperture at each end for receiving the shaft means to form a hanger loop pivotable about the shaft means for movement between a position adjacent the recessed portion and a hanging position.

Abstract: A fluid filter is disclosed which separates gas from liquid and vents the separated gas from the filter. The filter includes a vented housing through which the fluid stream passes. Liquid-wetting filter means carried in the housing in the path of the fluid stream permits the passage of liquid only. Gas separated from the fluid is vented through vent opening means which is covered by a liquid-repellent filter to permit the passage of gas only. An automatic pressure sensitive control means may be used to seal the vent opening means against the entry of ambient air but to automatically release separated gas from the filter. The liquid-repellent filter may be secured to the housing by a mechanical bond between the housing and a fibrous backing carried by the filter, or a continuous band of medical grade tape may be used to attach the filter to the housing.

Abstract: A membrane filter assembly is disclosed which employs at least one filter membrane and includes support means to prevent overflexing or overstressing of the filter membrane when high fluid pressures occur. The membrane support means includes a substantially co-extensive support or back-up surface spaced a small distance from the membrane to allow liquid flow therethrough but to prevent stretching or flexing beyond its elastic limit. Preferably the support surface comprises a second filter membrane in parallel flow relationship with the first to provide high flow rates during normal flow conditions but which flex together during high pressures conditions to mutually support one another and to prevent further flexure of either membrane beyond its elastic limit.

Abstract: A plastic hanger for medical containers or the like is described which, in its normal, unstressed position, lies adjacent the bottom of the container so as not to interfere with setting the container on a flat surface. The hanger is molded separately from the container and sealed or attached to a rib formed on the bottom of the container.

Abstract: A filter assembly is disclosed for use, in-line, in a medical fluid, e.g., parenteral solution, administration set or the like, to filter the fluid as it is administered to a patient. Hydrophobic and hydrophilic filter membranes are mounted in a parallel-flow relationship within a filter housing, which is sealed except for inlet and outlet ports. The membranes are respectively positioned so that the hydrophobic filter membrane is located above the hydrophilic filter membrane when the filter assembly is suspended in-line in an administration set, permitting any air separated from the fluid by the hydrophilic membrane to migrate upwardly and pass through the hydrophobic membrane instead of accumulating on the surface of and blocking flow through the hydrophilic membrane.

Abstract: Apparatus and method are disclosed for closing and sealing a molded plastic article formed by expanding a heated plastic parison within a chamber or cavity defined by a plurality of mold sections. The article is closed and sealed by at least one movable sealing member which has a protruding pinch surface to weaken or sever the parison and recess surface portions selectively above or below the protruding pinch surface which provide plastic-receiving reservoirs that aid in the formation of an unobtrusive seal adjacent the surface of the article. The sealing member may also include parison engaging seat or heel portions which further aid in the sealing operation. The temperature of the mold sections adjacent the sealing operation is controlled to selectively retard the cooling of the parison, which is in direct contact with the cavity surface, to maintain the parison at a sufficiently elevated temperature to permit closing and sealing by the sealing member.

Abstract: A flow regulator is disclosed for controlling the intravenous infusion of parenteral solution or the like to a patient. The solution flows through passageways in a housing, including a fixed volume portion. Fluid control means upstream and downstream of the fixed volume portion alternately open and close inlet and outlet passageways to periodically fill and empty the fixed volume portion, which is vented to allow displacement air to enter or exit. Hydrophobic filter means are provided in the vent path to permit venting but to prevent the escape of liquid. Hydrophilic filter means are provided downstream of the fixed volume portion to prevent gas or air from passing to the patient. The alternate opening and closing of the fluid control means in the inlet and outlet passageways permits a maximum fixed volume of liquid to be dispensed to the patient.

Abstract: A fluid filter is disclosed for use in filtering intravenous fluids as they are administered to a patient. The unique filter employs a normally hydrophobic (water-repellent) depth-type filter element, which has a sufficiently large pore size and volume of pores to permit an adequate gravitational flow of intravenous fluid from an elevated reservoir. Particulate matter is filtered out by the tortuous passageways in the filter element, through which liquid must pass. Due to the relatively large pore size (20 microns or larger) of the filter element, in combination with the normal hydrophobic property, any gas entrained in the liquid also passes through the filter element and does not accumulate on the filter surface to block flow therethrough--so called "air blocking".

Abstract: A diagnostic reagent dispensing bottle which includes a flexible container having an elongated cap mounting neck which is closed by a pierceable or punctureable membrane. A membrane-piercing-and-droplet-dispensing spike is also provided. The spike includes a conically-shaped orifice and a sharp membrane piercing point. The spike is carried by an elongated cap which has a body portion for mounting on the neck of the container. The neck and cap cooperate to position the spike in either (1) a shipping or non-piercing position or (2) a dispensing position wherein the spike pierces the membrane so that the reagent within the container can flow through the spike for dispensing. The cap also includes a cover or closure for closing the bottle which is hingedly connected to the cap body so that the cover is selectively positionable in either an open or closed position. Both detent and thread systems are disclosed for cooperation with the cap and neck to position and guide the spike relative to the pierceable membrane.