Abstract: Layered thermoplastic articles and a method for forming layered thermoplastic articles are provided. The method involves forming a layered, thermoplastic parison, followed by blow molding the parison in a mold cavity to form a desired configuration of hollow article. The blow molded articles can be of any configuration achievable with known blow molding technology. Every section of the article can be layered, or the article can have selectively intermittent layered sections. The containers typically are used for storing and dispensing liquids and are of one-piece construction. In accordance with this invention, the thermoplastic materials are of a type which are incompatible.

Abstract: A container for pooling plasma and the like has an integral cap. The cap includes an air vent with an inline bacterial filter. The cap also includes a fluid passage to which a length of tubing can be integrally connected to transfer fluid into the container. The transfer tubing can be sealed and severed close to the cap. The cap includes a pocket which receives the remaining sealed end portion of the tubing to protect the sealed end portion from inadvertent contact and damage during subsequent handling. The cap also includes a cover which closes the pocket to further enhance the protection of the sealed tubing end. The cover includes a plug which, when the pocket is closed, hermetically seals the vent and, thus, the entire container.

Abstract: An assembly for supporting a cannula comprises a hub which supports the cannula and which includes a post portion which concentrically surrounds a section of the cannula adjacent to the hub. The assembly also includes a cover which is attachable to the post portion of the hub to enclose the cannula. The cover and post portion are coupled together by a "tamper-proof" connection which normally resists removal of the cover, and thereby attests to the sterile integrity of the needle. The connection can be broken in response to the deliberate application of a predetermined rotational force by the user upon the cover and cannot thereafter be recreated, thereby serving as an outward indication that the sterile integrity of the cannula has been compromised. Both the post portion and the cover remain physically intact, despite the breakage of the connection, to permit return of the cover when desired.

Abstract: Antibody against human chorionic gonadotropin is raised in rats, preferably Lewis Strain Inbred rats, using either whole hormone or the .beta.-subunit as the antigen, and displays low cross-reactivity with luteinizing hormone as well as high sensitivity.

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: A method of storing a quantity of red blood cells uses a blood bag which comprises a plastic polyvinyl chloride formulation which contains from 5 to 30 percent by weight of a first plasticizer material which is essentially nonextractable by blood plasma stored in the bag up to 35 days at about 4.degree. C.; and from 10 to 25 percent by weight of a second plasticizer which is significantly extracted by blood plasma stored in the bag up to 35 days at about 4.degree. C. and which, upon leaching, is capable of suppressing the formation of plasma hemoglobin.

Abstract: A method of storing blood components uses a blood component storage container which is made of a plasticized polyvinyl chloride formulation which includes a heat stabilizer system selected from the group consisting of salts of C.sub.10 to C.sub.26 saturated fatty acids present in an amount of less than about one percent by weight of the composition. Surprisingly, use of only minimal amounts of these higher molecular weight fatty acids results in an effectively heat stabilized product suited for mass production techniques. As a result, the total amount of the heat stabilizer which can possibly leach into blood plasma is significantly reduced. The material from which the container is made preferably includes an effective amount of a plasticizer which is also essentially nonextractable in blood plasma.

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 pressure pump for fluids in flexible tubing, which comprises a pressure member of generally circular periphery adapted for orbital motion about an axis of rotation. A sleeve member is positioned about the pressure member and defines channel means for receiving and retaining the flexible tubing in a predetermined position between the pressure member and sleeve member, and surrounding the pressure member. The sleeve member may be divided into a pair of substantially semi-circular jaws attached together at one end in hinged relation, to permit opening and closing of the jaws about the pressure member to facilitate installation of the tubing.

Abstract: An apparatus for the continuous flow fractionation of whole blood incorporates motor driven whole blood, anti-coagulant and replacement pumps, negative and positive pressure monitors, and a dual bubble detector which function in conjunction with a disposable single-use flow system and a hollow fiber filter to separate and collect plasma from whole blood. Operation of the pump motors, pressure monitors and bubble detector is controlled by a control circuit within the apparatus to provide one of several operator-selected operating modes, including run, prime and reinfuse modes. The control circuit provides an alarm which can be cancelled by the operator when certain system parameters fall outside of normal operating limits, and interrupts operation of the pumps when the parameters exceed maximum limits. A failsafe circuit independent of the control circuits interrupts power to the pump motors in the event the motors do not stop upon detection of a bubble or fluid absence in the flow system.

Abstract: Apparatus for automatically connecting and disconnecting a pair of connectors includes first and second relatively movable means to carry the connectors and to move them back and forth between connected and disconnected positions. Rack and gear means may be used having a variable mechanical advantage at different positions to facilitate connection and disconnection of the connectors. The apparatus may also have means for providing radiation for antibacterial effect on the connectors, typically ultraviolet radiation.

Abstract: A pressure cuff draw mode enhancement system for a blood fractionation system having a single-lumen phlebotomy needle, a flow-through plasma separation filter, and an in-process fluid reservoir, includes a pressure cuff in operative association with the donor. During an initial draw cycle of the system whole blood is pumped by an inlet pump through the filter to the in-process reservoir. When a predetermined volume of filtered plasma-deficient blood has been collected in the reservoir, as sensed by the weight of the reservoir, the system reverts to a return cycle wherein a portion of the plasma-deficient blood in the reservoir is pumped back to the phlebotomy needle by a return pump. Depending on the relative operating rates of the inlet and return pumps, an operator-controllable portion of the plasma-deficient blood from the in-process reservoir is returned to the donor through the phlebotomy needle, and the remaining portion is recirculated through the filter.

Abstract: A method for making a hollow fiber separation device including the steps of forming an integral structure which comprises at least one tubular housing portion and an elongated chamber portion extending in elongated relation to the tubular housing portion and communicating with the housing portion adjacent opposed ends thereof. One provides an aperture in a central area of the elongated chamber and inserts hollow fibers for diffusion into the housing portion. One then provides closed ends to the housing portion and spins the structure on an axis between the ends, adding potting compound to the chamber portion through the aperture. Accordingly, the potting compound migrates radially outwardly through the chamber to the closed ends of the housing portion, to encase the ends of the hollow fibers in the potting compound.

Abstract: A cannula support assembly comprises a hub subassembly, which supports the cannula, and a cover subassembly, which attaches to the hub subassembly to sealingly enclose the cannula prior to use and which can be easily removed from and subsequently reattached to the hub subassembly, if desired. Each subassembly is itself preferably fabricated from one or more individually extruded component parts which can be assembled together in a manner lending itself to cost efficient, automated production techniques and which thereby obviates the use of substantially more costly injection molded or compression molded plastic parts. The resulting support assembly is durable, easily attachable to flexible tubing, and readily adaptable to diverse uses, such as a hub and cover for a phlebotomy needle or an inline sampling needle.

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: Viruses, particularly hepatitis viruses, in blood clotting enzyme compositions are inactivated with little enzyme activity loss by heating the compositions in the dry state. The novel products which result are therapeutically and diagnostically useful.

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 monitoring system for monitoring trans-membrane pressure in plasmapheresis apparatus utilizing a microporous membrane type filter includes first and second pressure-to-frequency transducer circuits for developing signals frequency-indicative of the inlet and outlet pressures of the filter. The signals are digitally compared in a pulse subtraction circuit to produce an output signal frequency-indicative of trans-membrane pressure. The output signal is applied to a periodically reset display counter to develop a digital readout of trans-membrane pressure. Porous filter elements in the flow system and in the inlet port of each transducer isolate bacteria within the flow system, prevent contamination of the transducers, and provide a time constant for each transducer which prevents transient flow variations in the system from causing erroneous trans-membrane pressure readings.

Abstract: Carcinoembryonic antigen contains immune determinates in common with .alpha.-acid glycoprotein. Carcinoembryonic antigen-containing compositions are purified by adsorption onto antibody to .alpha.-acid glycoprotein. The purified compositions may be employed as standards in carcinoembryonic antigen assays or in the labelled form as tracers. Intact carcinoembryonic antigen is assayed by a modified sandwich-type immunoassay. Other cancer-associated substances may be identified by searching for high molecular weight analogues of normal proteins.