Abstract: An improved peritoneal dialysis solution comprising an osmotic agent having at least one amino acid, and a method of administering same to a patient are provided. Pursuant to the present invention, the sodium concentration in the solution is decreased thus causing sodium to be transported from the circulation to the peritoneal cavity. This provides for an improved ultrafiltration profile that is, more volume over a longer period of time, for the same initial osmolality when compared to standard solutions. Also, the same ultrafiltration profile as standard solutions can be achieved with lower initial osmolalities.

Abstract: An improved adaptor and protector for same which is removably sealing an opening of the adaptor located at an end of a tubular member. The adaptor has a longitudinal passageway for receiving a cannula. An upper end of the adaptor has an interior diameter defining a first end of the passageway for receiving the cannula. A lower end of the adaptor has an interior diameter defining a second end of the passageway adapted for receiving an injection site wherein the diameter of the first end is larger than the diameter at the second end. A middle portion intermediate the first end and the second end has a tapering interior diameter for directing the cannula to the injection site and further having an exterior surface with gripping surfaces. The tapering interior diameter of the middle portion of the adaptor includes guiding members to direct the cannula or other injection devices. The adaptor may also be provided with a protector removably sealing an opening located at an end of the adaptor.

Abstract: The present invention provides improved methods for manufacturing solutions including medical solutions. To this end, in an embodiment, a method for preparing a medical solution is provided comprising the steps of: placing a solution in a gas permeable container; and allowing carbon dioxide to permeate through the container until a desired pH is achieved.

Abstract: The present invention provides a method for inactivating pathogens in a body fluid, such as plasma, red cells, platelets, leukocytes, and bone marrow. The present invention minimizes adverse effects caused by the photosensitive agents while retaining the disinfecting activity of such agents and processes. Pursuant to the present invention, prior to irradiating a body fluid including a photoactive drug, the extracellular fluid, which in the case of blood components includes plasma proteins is at least substantially reduced. Additionally, after the irradiation process, the resultant body fluid is prevented from contacting additional extracellular fluid, e.g., plasma proteins, for a predefined period.

Abstract: Peritoneal dialysis solutions are specially formulated for use during and immediately after an episode of peritonitis. The solutions include one or more additives to minimize the injury and physiological effects that peritonitis can cause. One additive is a mixture of amino acids sufficient to maintain a positive nitrogen balance, at least one of the amino acids being present in a dipeptide form. Another additive is a compound that scavenges free radicals generated by peritoneal macrophages activated by the peritonitis. Another additive is chondroitin sulfate that changes the permeability of the peritoneal membrane during subsequent dialysis using solutions free of chondroitin sulfate. Another additive is the degradation products of hyaluronic acid to enhance the regeneration of the peritoneal mesothelium without fibrosis.

Abstract: A connector assembly, preferably for medical use, is provided having a key component and a lid lock component to provide fluid communication between a fluid source and a destination such as a patient. The lid lock component includes a removably lockable lid. The lid is held closed in a locked position by stops located on at least one flexible arm integrally formed and selectively displaceable in the lid lock component. The lid is forced open by a longitudinal key within the key component. The key spreads the flexible arms so that the formerly locked lid is capable of passing through an opening created between the flexible arms to clear the stops. The lid is converted into a position parallel to the length of the lid lock component to provide fluid communication between tubing connected to the lid lock component. The connector assembly can be used for dialysis and the like.

Abstract: A method for separating blood into its components and individually storing same is provided. The method has the steps of: providing a container having a body with at least a first and second chamber. Selective fluid communication is also possible between the first and second chamber, and a tube is in fluid communication with the first chamber. The method also has the steps of: passing the blood into the first chamber through the tube; centrifuging the container to separate the blood into plasma, red blood cells and buffy coat within the first chamber; and expressing a portion of the centrifuged blood into the second chamber. In another embodiment, the method for storing blood has the steps of: providing a container with a body having three chambers.

Abstract: A system and method is provided which substantially eliminates the effect of air entrapped in tubing for delivering a liquid from a container. The inner diameter of the tubing is selected such that the gravitational force of the liquid from the container is greater than the surface tension of the liquid. A release agent may be used as a coating layer on the interior wall in addition to or alternatively from an expanded diameter.

Abstract: A multiple chamber container for mixing and administering a plurality of products. The container has at least two chambers separated by a seal line. A frangible connector is situated between the two chambers for mixing the products contained within the chambers as desired. Each chamber has at least one port for filling of product into the chamber. The ports are located on the same exterior side of the container such that the chambers can be filled without folding the bag and by using existing filling equipment.

Abstract: A system and a method are provided for detecting a bag that has been subjected to a process, such as illumination, wherein the contents of the bag require processing before subsequent use. The system (1) has a drawer (10) on which one or more bags may be placed and properly oriented. Punches (22) are provided for punching slugs from the bag indicative of a status of the processing of the bag. The punches (22) are aligned with die apertures (26) of a die (24) and corresponding punch apertures (20) through the drawer (10). The bag may include polarizing materials (50) such that the status of the processing of the bag (52) may be sensed. To this end, a rotating polarizing piece (70) is provided as well as a light source (34) and a sensor (38). The polarities between the polarizing piece (50) of the bag and the rotating polarizing piece (70) is monitored by the sensor (38) to indicate a condition or status of the processing of the bag and/or to further indicate tampering taking place in the process.

Abstract: A connector assembly is provided having a male component (12) and a female component (10) to provide fluid communication between a fluid source and a destination such as a patient. The female component (10) includes a door (28) rotatable about a hinge (30). The door (28) is forced open by a longitudinal member (34) within the male component (12). The door (28) is converted into a position parallel to the length of the female component (10) providing fluid communication between a tubing (36) extending into the female component (10). A sleeve (44) is further provided to permit and to prevent fluid flow through a tubing by rotation of the sleeve (44) resulting in compression and expansion of longitudinal members (46) within the sleeve (44) and thereby the tubing.

Abstract: A method and apparatus for inactivating viruses in a body fluid. A mixture including a therapeutically effective amount of methylene blue and an amount of a body fluid is formed in a container under sterile conditions and then the container is irradiated with a light field of a suitable intensity and wavelength for activating the methylene blue for a time sufficient to inactivate viruses in the mixture. The mixture is maintained in a substantially static state within the container.

Abstract: The invention provides dual-skinned membranes useful as one way or rectifying membranes which reduce back filtration of solute molecules in dialysis and which improve nutrient supply and product recovery in membrane bioreactors. The membranes are dual-skinned polymeric materials preferably in the form of hollow fibers. The membranes have skins of polymer on the opposite sides with differing permeability to solutes and sieving coefficient characteristics. The skin on each side have pores that are invisible at 10,000 times magnification, the microporous structure between said skins contains pores capable of retaining solutes in a molecular weight range of about 5000 to 200000 in an increased concentration between the interior and the exterior skins. Improved dialysis devices are formed by using bundles of the hollow fiber membranes as a dialysis means having rectifying properties.

Abstract: A fluid-carrying bag (10) or container is provided as well as a method for forming such a bag. The bag (10) has identifiers (28a, 28b) indicating a status of the contents of the bag (10). To this end, a first layer and a second layer of preferably flexible material are sealed to form an interior (14) capable of holding a fluid. A flap (18) is provided wherein at least one hole (28a) may be punched through the flap (18) which is capable of detection by a sensor to indicate treatment of fluid within the interior (14) of the bag (10). One or more polarizing pieces (116a,b) may be provided between the fused layers (102, 104) in the flap (112) at a location through which the at least one hole (116a,b) is punched indicative of treatment of the fluid in the interior (108) of the bag (110).

Abstract: A system and method using same are provided for determining the optimum operating conditions of a dialysis process that yields the highest whole body dialysis clearance. The system varies a parameter that effects dialysis efficiency during part of a dialysis run. The system then measures a metabolite concentration in an outflow dialysate. The system develops a metabolite concentration profile as a function of the varied parameter. Based on these measurements, the system correlates the metabolite concentration measurements to determine the optimum parameter setting that yields the maximum metabolite concentration.

Abstract: A label for a blood bag comprising a microporous plastic film including a matrix of interconnected pores for allowing gas to flow into and out of the blood bag through a labeled area. The pores allow ink to be absorbed at least on an outer surface of the label allowing the label to be printed and/or written on. The labels of the present invention have breathability with respect to gas that is similar to paper. However, the label is more durable than a paper label in that it can tolerate moisture, abrasion, temperature extremes, dimensional changes, and the like. Accordingly, the labels do not crack or wrinkle as easily as paper labels.

Abstract: An improved adaptor and protector for same which is removably sealing an opening of the adaptor located at an end of a tubular member. The adaptor has a longitudinal passageway for receiving a cannula. An upper end of the adaptor has an interior diameter defining a first end of the passageway for receiving the cannula. A lower end of the adaptor has an interior diameter defining a second end of the passageway adapted for receiving an injection site wherein the diameter of the first end is larger than the diameter at the second end. A middle portion intermediate the first end and the second end has a tapering interior diameter for directing the cannula to the injection site and further having an exterior surface with gripping surfaces. The tapering interior diameter of the middle portion of the adaptor includes guiding members to direct the cannula or other injection devices. The adaptor may also be provided with a protector removably sealing an opening located at an end of the adaptor.

Abstract: The present invention provides a method for testing a blood unit for viral contamination without rendering the blood unit unusable for therapeutic applications. The method comprises the steps of: removing and collecting from a blood unit a majority of the leukocytes present therein with a leukocyte filter; and using the leukocytes collected in and on the filter to test the blood unit for viral contamination. The present invention also provides a method for validating viral inactivation processes.

Abstract: Dual-skinned membranes are provided useful as one-way or rectifying membranes which reduce back filtration of solute molecules in dialysis and which improve nutrient supply and product recovery in membrane bioreactors. The membranes are dual-skinned polymeric materials preferably in the form of hollow fibers. The membranes have skins of polymer on the opposite sides with differing permeability to solutes and sieving coefficient characteristics. The skin on each side have pores that are invisible at 10,000 times magnification. A microporous structure between the skins contains pores capable of retaining solutes in a molecular weight range of about 5000 to 200,000 in an increased concentration between the interior and the exterior skins. Improved dialysis devices are formed by using bundles of the hollow fiber membranes as a dialysis member having rectifying properties.

Abstract: The present invention provides a coextruded tubing that has been optimized for usage in cryogenic freezing applications. To this end, a coextruded tubing is provided having three layers, a first layer of ethylene vinyl acetate; a second layer of polyolefin; and a third layer of polyvinyl chloride. An improved container for use in cryogenic freezing applications is also provided.