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: Method and apparatus for machine separation of blood and blood components that utilizes improved administeration of anticoagulant to the red cell suspension output. Anticoagulant is added to incoming whole blood in an amount sufficient to prevent clotting of the whole blood in the flow path upstream of the blood component separator, but in an amount insufficient to prevent clotting of the red cell suspension created by the separator. Anticoagulant is added to the red cell suspension downstream of the separator in order to prevent clotting. By adding an additional aliquot of anticoagulant to the red cell suspension, the amount of anticoagulant added to whole blood before separation can be reduced or eliminated, resulting in an increase in platelet yield during the blood component separation step.

Abstract: Systems and methods of collecting blood cells use a first container connected to initially collect blood. A filtration system is provided that uses two flow paths, the first being a dual purpose path that is initially used to convey plasma and platelets to a pair of transfer/storage containers. A second flow path leads to a temporary transfer container through a filtration device. The dual purpose fluid path is next used to convey blood cells, now substantially free of undesired matter, from the temporary storage container to a storage container. The filtration system is then detached from the blood collection system.

Abstract: A system and method of separation of therapeutic components from blood. The system includes a dual member centrifuge and a disposable single use fluid transfer set. The set includes an elongated flexible separation chamber having an input port, a separated component output port and a residual fluid output port. The input port and the separated component output ports are located at opposite ends of the elongated separation chamber. The centrifuge includes a receiving chamber with a selectively formed annular slot therein. The separation chamber is positioned in the annularly shaped slot and rotated at a predetermined rotational velocity. Fluids such as whole blood flows through the separation chamber and are separated into various therapeutic components such as platelet rich plasma and residual concentrated red blood cells. Platelet rich plasma can be drawn off as the separated therapeutic component. An alternate two part transfer set provides for highly efficient platelet pheresis.

Abstract: A flexible plastic container made from a flexible, autoclavable, non-PVC polymer composition capable of suppressing the hemolysis of red blood cells. The polymer contains a material selected from the group consisting of either triethylhexyltrimellitate (TEHTM) and citrate ester. In the preferred embodiment, the non-PVC plastic is comprised of a polyolefin copolymer containing a central block of ethylene and butylene units with terminal blocks of polystyrene.

Abstract: A centrifugal processing system and method introduces fluid to be processed into a centrifugation chamber, while directing the fluid away from the region of the chamber where the largest centrifugal (or "G") forces exist. The fluid is also conveyed into the force field as a generally uniform stream having reduced turbulence or being essentially free of turbulence. The system and method thereby establish, upon the entry of a high velocity fluid stream into the centrifugal field, non-turbulent and uniform flow conditions conducive to effective separation. The system and method also direct the fluid in a way the maximizes the effective surface area of the centrifugation chamber for separation. Effective separation can thereby be achieved at high inlet flow rates.

Abstract: A system and method of separation of therapeutic components from blood. The system includes a dual member centrifuge and a disposable single use fluid transfer set. The set includes an elongated flexible separation chamber having an input port, a separated component output port and a residual fluid output port. The input port and the separated component output ports are located at opposite ends of the elongated separation chamber. The centrifuge includes a receiving chamber with a selectively formed annular slot therein. The separation chamber is positioned in the annularly shaped slot and rotated at a predetermined rotational velocity. Fluids such as whole blood flows through the separation chamber and are separated into various therapeutic components such as platelet rich plasma and residual concentrated red blood cells. Platelet rich plasma can be drawn off as the separated therapeutic component. An alternate two part transfer set provides for highly efficient platelet pheresis.

Abstract: A medical fluid administration set is disclosed which may be used for the passive reconstitution and delivery of a drug or other beneficial agent with liquid flowing through the administration set. A receptacle mounted in the administration set is adapted for receiving a cartridge containing the beneficial agent. Also disclosed is an adapter for connecting the cartridge and the receptacle and an air flask within the administration set.

Abstract: A system for continuously esparating lighter and intermediate density matter, such as plasma rich in platelets from whole blood moves blood through a diverging centrifugation gap between inner and outer walls of a rotor rotating about a central axis within an outer housing. The centrifugation action creates layered flow along an intermediate section. However by crating trailing wakes in the gap between the rotor and housing, localized remixing patterns tending to move in the opposite direction are induced in the layered matter. Platelet rich plasma may then be extracted through adjacent platelet concentrate ports on the inner wall of the rotor. An interior passageway system passes the platelet rich plasma to a platelet concentrate reservoir. Recirculation of blood in the rotor-housing gap between the output and input, and pumping action provided by the diverging centrifugation gap, aid in enhancing throughput and concentration levels.

Abstract: The present invention provides an intravenous administration set 10 having a primary container 22 and a secondary container 24, each containing fluid, and a pump 20. The primary container 22 and secondary container 24 are joined into a single flow path by a Y-site 50. A check valve 42 is provided between the primary container 22 and the Y-site 50. A fluid capacitor 60 is provided on the single flow path between the Y-site 50 and the pump 20 to repenish displaced fluid in the pump 20.

Abstract: An ampule defines a pair of opposed, flexible sides, sealingly enclosing a space which contains a mass of beneficial agent which is soluble in aqueous solution. Inlet and outlet ports communicate between the space and the exterior. Flow promoting means are positioned between the mass of beneficial agent and at least one opposed, flexible side to facilitate the formation of a fluid flow path along the mass of beneficial agent.

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: An apparatus is provided for the safe, passive reconstruction of a drug or other beneficial agent, without requiring manual reconstitution steps. The apparatus includes a housing, preferably having a receptacle "in-line" in an administration set and forming part of an intravenous delivery system, and a cartridge adapted for receiving a beneficial agent or beneficial agent and carrier. The cartridge is plugged into the receptacle to initiate reconstitution of the agent. The apparatus creates first and second delivery modes, in which the delivery rate of the agent to a patient is independent from and dependent upon, respectively, the fluid flow rate through the intravenous delivery system.

Abstract: A method and device are provided for infusing a fluid into a patient via a tubing. A peristaltic pumping apparatus is provided which applies a pumping action to the tubing. A linear variable differential transformer measures the diameter of the tubing subject to the pumping action. The diameter of the tubing is measured at various times and changes in the diameter of the tubing are utilized to adjust the pumping action on the tubing.

Abstract: The invention provides a flow control system well suited for use in intravenous fluid delivery systems comprising a flow restrictor wafer having one or more flow limiting flow restrictor paths formed thereon. The system provides fixed flow rate control. The system also provides means for selectively orienting at least two flow restrictor paths relative to the main fluid passage to varying the flow rate.

Abstract: The present invention provides both a continuous dose and a bolus dose of fluid or beneficial agent to a patient. A source of fluid is in fluid communication with a continuous flow path for providing the patient with a continuous source of the beneficial agent. The source of beneficial agent is also connected to a bolus dose apparatus which provides patient control of a bolus dose of the beneficial agent, up to a preselected maximum.

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: An encoder wheel (60) is provided for monitoring a peristaltic pump (20). The encoder wheel (60) provides a plurality of equispaced sectors (62) and a reference sector (66) provided at the outer radius of the encoder wheel (60). A vane slit (68) is provide radially offset from the sectors (62,66). A pair of optical couplers (72,74) are provided to read the sectors (62,66) and the vane slit (68).

Abstract: Systems and methods of collecting blood cells, substantially free of undesired matter, use a first container, that forms a part of a blood collection system, to initially collect a quantity of blood cells. A filtration system is then attached to the first container. The filtration system includes a second container, a first fluid path that leads to the second container through a filtration device, and a second fluid path that leads to the second container bypassing the filtration device. The blood cells are conveyed from the first container through the first fluid path and filtration device and into the second container to separate the undesired matter from the blood cells. The blood cells, now substantially free of the undesired matter, are then conveyed from the second container through the second fluid path, bypassing the filtration device, and back into the first container. The filtration system is then detached from the blood collection system.

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.