Abstract: Blood processing systems and methods separate whole blood into red blood cells and a plasma constituent within a rotating centrifugal separation device. The systems and methods convey whole blood into the separation device through an inlet path including a pump operable at a prescribed rate. The systems and methods remove plasma constituent from the separation device through an outlet path including a pump operable at a prescribed rate. The systems and methods derive a value Hb representing an apparent hematocrit of whole blood entering the separation device, where: H b = H rbc ⁡ ( Q b - Q p ) Q b and where Hrbc is a value relating to hematocrit of red blood cells in the separation device.

Abstract: A steam sterilizable unit for inactivating pathogens in a body fluid is provided including a plastic structure for housing a therapeutically effective amount of a methylene blue solution. The plastic structure preferably includes at least an inner layer constructed from a non-PVC plastic. Preferably, the methylene blue solution has a pH of less than 7.0 and preferably less than or equal to approximately 6.3.

Abstract: Methods for reducing or preventing the transmission of transmissible spongiform encephalopathy through blood or blood products are provided. The methods require the intact removal of leukocytes that are present in a blood product or an intermediate of a blood product prior to administering the blood product to a patient. To prevent or reduce the transmission of transmissible spongiform encephalopathies disease substantially all leukocytes are removed intact without significant lysis of such leukocytes.

Abstract: Systems and methods separate platelets from a selected donor. The systems and methods convey anticoagulated blood containing plasma and platelets from the selected donor into the separation device for separating into a plasma yield and a platelet yield. The systems and methods estimate, at least in part while separation occurs, a count of platelets (PltCirc) available for collection from the selected donor by measuring the selected donor's platelet precount (Pltpre), estimating a dilution factor caused by addition of anticoagulant (Dilution), and estimating a depletion factor (Depletion) caused by removal of available platelets during blood processing. In estimating Depletion, the systems and methods take into account a splenic mobilization function (Spleen), which is derived from a population of donors and not specific to the selected donor, where Spleen comprises a function of PltPRE.

Abstract: Apparatus and methods for treating a biological fluid with light and for inactivating contaminants in biological fluid. The biological fluid is contacted with a light source providing a high intensity light to the biological fluid. The biological fluid may include a quantity of a photochemical agent that when activated by light is operable to cause inactivation of at least some of the contaminants.

Abstract: System and methods treat plasma carrying contaminants and cellular matter that are capable of entraining contaminants. The systems and methods separate cellular matter from the plasma by filtration, thereby removing contaminants entrained within the cellular matter. The system and methods add to the plasma a photoactive material. The systems and methods emit radiation at a selected wavelength into the plasma to activate the photoactive material and thereby eradicate the contaminant that is free of entrainment by cellular matter.

Abstract: A pump module includes a peristaltic pump having a pump rotor, a drive mechanism to rotate the rotor, and a tubing clamp adjacent to and separate from the peristaltic pump. A cover is movable between a closed position on the pump module, enclosing both the pump rotor and the tubing clamp, and an opened position spaced from the pump module, exposing both the pump rotor and the tubing clamp. The cover carries a tubing organizer, which holds tubing. The tubing organizer serves, as the cover moves toward the closed position, to orient the tubing in a desired way with the pump rotor and tubing clamp. The tubing organizer also serves, as the cover moves toward the opened position, to orient the tubing away from the pump module.

Abstract: Viral and bacterial contaminants present in biological solutions are inactivated by mixing one of a novel class of photosensitizer with said solution and irradiating the mixture.

Abstract: Blood processing systems and methods rotate a processing chamber on a rotating element. The processing chamber includes a first compartment and a second compartment. Blood is conveyed into the first compartment for centrifugal separation into components. A liquid free of blood occupies the second compartment to counter-balance the first compartment during rotation on the rotating element. In one embodiment, the second compartment is served by a single fluid flow access. Prior to use, the single access is coupled to tubing, through which a vacuum is drawn to remove air from the second compartment. While the vacuum exists, communication is opened between the tubing and a source of liquid. The vacuum draws the liquid into the second compartment through the single access, thereby priming the second compartment for use.

Abstract: A breakable seal is located within a housing. The housing includes a ribbed region of restricted diameter protruding from the wall into the bore. A breakable juncture in the seal joins the tip of a cannula member to the base of the cannula member. The leading portion of the tip is free of any projection that frictionally engages either the wall or the ribbed region. Thus, neither the wall nor the ribbed region contacts or constrains movement of the leading portion in the bore when the tip is broken from the base. The trailing portion of the tip carries at least one projection constructed to frictionally engage the ribbed region. The ribbed region constrains movement of the trailing portion through the bore when the tip is broken from the base. By rocking the cannula tip, the juncture can be broken and the cannula tip advanced to a secure position in the housing.

Abstract: An apparatus for obtaining liquid samples from a fluid flow path is disclosed. The apparatus includes a housing having an access site communicating with the flow path and carrying a piercing member at a location spaced from the access site. The housing allows for translational movement of the piercing member toward the access site and into the flow path from where the sample is removed.

Abstract: Membranes and methods for making membranes are disclosed. The membranes include a polymeric matrix and a particulate material immobilized within the matrix. The membranes may find particular application in methods and apparatus for removing organic compounds from a biological fluid as part of a pathogen inactivation treatment.

Abstract: The invention provides a leukodepletion filter including a plurality of glass fiber filter pads, and a plurality of non-woven polyester fiber filter pads, sealed within a filter housing.

Abstract: An aseptic/sterile fluid connection between two containers is formed by radio frequency sealing together portions of transfer regions of two containers. Each transfer region has a layer of a relatively high melt temperature material such as a rubber or elastomer positioned between two outer container walls made of a flexible thermoplastic, for example polyvinyl chloride. The transfer regions are placed in registry, and the radio frequency welding fuses together portions of adjacent container outer walls and forms a fluid opening therethrough.

Abstract: A container for housing body fluids, preferably blood in its component form. The container comprises a body defined by flexible walls having an interior for housing the body fluid. Additionally, a means for allowing selective fluid flow allows the blood components to be expressed from one chamber of the container into another to separate and separately house the blood components. The present invention also provides a method for separating blood into its components and individually storing same.

Abstract: A container has first and second walls, each formed of a thermoplastic sheet having a peripheral edge. A peripheral seal joins the peripheral edges together to form an interior chamber enclosed by the first and second walls. A port communicates with the interior chamber. The port is spaced from and does not extend through the peripheral seal. The port comprises a hollow thermoplastic tube, which extends through a slit in one of the first and second sheets and is oriented tangentially thereto. The slit is fused by heat about the tube, forming a heat fused junction. A medical product or a blood filter material can be housed in the interior chamber.

Abstract: The coating of a RF active material on a non-RF active substrate material of typical thickness for packaging purposes, can generate sufficient thermal energy to effect strong bonding of the substrate materials. The RF active material may be deposited on less than the entire inner surface area of the substrate material, preferably, at or near the portion of the substrate surface which represents the heat seal interface. In this manner of application, additional coating or printing of other substances on the substrate surface can be achieved without hampering the heat sealing process. Flexible medical containers capable of containing a product which is maintained and removed under sterile conditions, can be constructed on commercial production machines from these coated non-RF active substrate materials.

Abstract: The present invention provides a system and method for creating on site, remote from a sterile environment, parenteral solutions in large volume parenteral containers for intravenous administration to a patient. In an embodiment, this system comprises an empty large volume container including at least one port for accessing an interior of the container. The port includes a sterilizing filter for sterilizing a fluid fed through the port into the container. A second container is provided including a solute and having means for coupling the second container to the large volume container and thereby providing fluid communication therebetween allowing the solute to be received within the interior of the container. A sterile water source is also provided including means for placing the sterile water source in fluid communication with the port and allowing water to flow from the sterile water source into the interior of the container.

Abstract: The present invention relates to a container, system, and method for creating parenteral solutions at a site, remote from sterile environments. The system includes a flexible container that is empty except for a prepackaged amount of a solute that is housed in the interior of the container. The container includes at least one port and a sterilizing filter in communication with an interior of the port. The container is so constructed and arranged that a fluid flow path is created from the port through the filter and into the interior of the container. A sterile water source including means for establishing fluid flow from the sterile water source into the port is provided. Accordingly, sterile water can flow from the sterile water source through the filter into the container where it is mixed with the solute to create a parenteral solution that can then be infused into a patient. A method and container are also provided.

Abstract: A bottle carrier including composite openings that include a round oversized opening to permit vertical entry of a bottle neck having a supporting flange therethrough, and an adjoining keyed opening wherein the bottle can laterally be slid into the keyed opening to be held therein. The supporting flange, being larger than the keyed opening, supports the bottle thereon. Each keyed opening is provided with retaining members which are arranged on either side of the keyed opening and which resiliently grip a backside of a diameter of the bottle neck or flange after the bottle neck is laterally slid into the keyed opening. Laterally arranged ribs are provided at each opening which provide the frame with sufficient thickness to resiliently compress between the flange of the bottle and a transition shoulder of the bottle to tightly grip the bottle into the keyed opening.