Abstract: Blood separation systems and methods draw whole blood from a blood donor selected from a population of blood donors. The whole blood of the selected blood donor has a known hematocrit value that varies within the population of blood donors according to morphology of the selected blood donor. The systems and methods operate a pump in the inlet line to convey a volume of whole blood from the donor at a commanded flow rate for processing into plasma constituent and concentrated red blood cells. The systems and methods set the commanded flow rate to vary the volume of whole blood conveyed over time as a function of the known hematocrit value of the selected donor. The systems and methods obtain, after processing the whole blood volume, a targeted volume of concentrated red blood cells, which is substantially constant for the population of blood donors despite variances in known hematocrit values among the donors.

Abstract: A packaging system for a sterilizable item comprising a pouch having a frangible opening, the pouch defining a sterile compartment therein to hold a sterilizable item and a support element for fluid attachment to a sterilizer, the support element defining a window thereupon, the support element attached to the pouch along a perimeter of the opening. The opening may comprise a scored portion cut into the front side of the pouch. The support element may be a rigid cardboard support element defining a perforated window with a knockout piece. The system may also include a cover adhered with the window for ensuring that the knockout piece remains attached to the support element until broken. The system may also include an adhesive strip attached along a perimeter of the cover, and include a removable backing strip.

Abstract: A method is provided for priming a hollow fiber oxygenator which is integrated with a hollow tube heat exchanger. A closed priming circuit is created between a cardiosurgery reservoir, the combined hollow fiber oxygenator and heat exchanger and a vacuum source. Vacuum pressure is applied to the closed priming circuit to evacuate the residual air from the circuit. Priming solution is released from the cardiosurgery reservoir and fills the evacuated closed priming circuit.

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 one-piece hydraulic circuit is provided for use with a blood dialyzer for performing functions currently performed with a multiplicity of blood inlet and outlet sets and related items comprising flexible tubing and the like.

Abstract: A solution bag formed of three plastic walls sealed together about their peripheries to define a pair of separate chambers is provided for peritoneal dialysis and the like.

Abstract: A noninvasive pressure monitor for measuring the pressure in a hydraulic circuit, such as an extracorporeal blood circuit, includes an aperture sealed by a membrane which offers substantially no resistance to pressure and a pressure sensitive transducer in contact with the membrane for providing a more direct measurement of the pressure.

Abstract: There is disclosed herein an improved needle assembly or fistula set which includes a hollow metal needle, a larger plastic fluid-carrying conduit, and plastic spacers between the needle and the conduit. The conduit and spacers are heat sealed to each other so as to provide a fluid-tight junction with the needle.A method for heat sealing the fistula set is also disclosed. In that method, the needle is used as one electrode and the other electrode includes jaw-like members which engage and surround the conduit at the junction where the heat seal is to be formed. During the heat sealing operation, the conduit and needle are maintained in substantial coaxial alignment so as to assure coaxial alignment thereafter.A fixture or tooling apparatus is also disclosed for effecting heat sealing and assuring substantial coaxial alignment.

Abstract: A connector system for use in a dialyzer is disclosed herein for connecting an external fluid conduit to a tubularly-shaped, semipermeable membrane. The system protects the membrane from forces imposed on the conduit. The system includes a jack member, which is secured within the dialyzer and has a passageway, which at one end is connected to the conduit and which at the other end is connected to a button-type connector which provides communication between the passageway and the semipermeable membrane. The button connector includes a cap and a barrel and has a passageway extending through the cap and barrel. An O-ring is provided for engaging both the jack member and the connector for cooperation in assuring fluid flow from the conduit to the semipermeable membrane.

Abstract: A sterile connector system is provided for continuous ambulatory peritoneal dialysis in which a dialysate solution container having a transfer port is coupled to tubing extending from a patient's peritoneal cavity. The transfer port is connected to one end of a flexible housing and the patient's tubing is connected to the opposite end of the flexible housing. A sterilizing agent is introduced into the housing and in contact with the transfer port and the patient's tubing. The sterilized transfer port is thereafter connected to the sterilized patient's tubing within the housing.

Abstract: The ultrafiltration provided by an operating dialyzer is measured by sealing a portion of the dialysis solution flow path, including the dialysis unit, to prevent solution flow into or out of the portion, while effecting flow of the liquid to be dialyzed through a second flow path in the dialysis unit. Simultaneously, the dialysis solution flow path is in communication with a solution receptacle, at least part of which is vertically elevated over the dialysis unit. Accordingly, dialysis solution flows into the receptacle over a period of time under these conditions in a manner corresponding to the ultrafiltration of the dialysis system.