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: A medical grade tubing that includes a layer of ultra low density polyethylene that has been let down, or drawn down, in diameter approximately 10% to about 50% in an extrusion process and an inner layer of an RF responsive material, the tubing allowing for the selective connection of the tubing to another tubing using a sterile welding device.

Abstract: A flexible container comprises first and second flexible sheets of plastic material having peripheral edges, which have been sealed together along a plane to create an interior chamber in the container. At least one of the first and second flexible sheets includes a preformed, stress-relieved region, which is extended outside the plane and overlies at least a portion of the interior chamber.

Abstract: A method for treating a body fluid to at least substantially inactivate viral contaminants that may be present therein is provided. The method includes the steps of: providing a body fluid; adding to the body fluid a viral inactivating agent to create a resultant product; and passing the resultant product through a column including material having an affinity for the viral inactivating agent.

Abstract: A flexible, three-dimensional container is made by a prescribed vacuum-molding and heat sealing process. The container possesses a precise, defined geometry before and during use. The container is formed from first and second walls. The first wall has a planar area and a vacuum-molded cavity area drawn out of the plane of the planar area into a predefined three-dimensional geometry. A second wall overlies the first wall to close the cavity area and thereby forms an interior compartment. A thermal seal joins the two walls together. The seal is formed by heating the second wall and the first wall in the planar area, while assuring that the cavity area of the first wall is not subject to heating and possible deformation of its precise vacuum-molded geometry.

Abstract: Assemblies and methods process cord blood in a sterile fashion to avoid exposure to bacterial contamination. A transfer tube couples a cord blood processing container to an other container, which, in use, holds a cryopreservative solution. The transfer tube has an interior diameter that is restricted substantially along its entire length, to meter the introduction of cryopreservation solution into cord blood at a desired rate, thereby avoiding damage or trauma to the cord blood cells.

Abstract: A system and method for treating a fluid carrying a contaminant to which a photoactive material has been bound include a treatment device that defines a flow passage with a gap. The system and method operate to establish a flow of fluid from the inlet end of the gap to the outlet end of the gap. The system and method also channel the flow of fluid in the gap in succession through one or more flow paths. The system and method establish at least two discrete sources of radiation in the flow path at spaced apart locations along the direction of fluid flow. At least one of the radiation sources comprises a photodiode. The system and method further include a control for operating each discrete source of radiation at a selected wavelength within the prescribed range to activate the photoactive material bound to the contaminant. Upon activation, the material eradicates the contaminant.

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: A system and method for treating a fluid carrying a biological contaminant to which a photoactive material has been bound include a treatment device that defines a flow passage with a gap. The system and method operate to establish a flow of fluid from the inlet end of the gap to the outlet end of the gap. The system and method expose the fluid, as it transits the gap, to a source of radiation that activates the photoactive material bound to the contaminant. The system and method also mix the fluid as it flows within the gap.

Abstract: Systems for treating a fluid carrying a contaminant to which a photoactive material has been bound include a treatment device that defines a relatively narrow, arcuately shaped flow path. These systems envelop the path with a radiation chamber that directs radiation from one or more sources into the fluid.

Abstract: The present invention provides an accurate method and apparatus for monitoring the drop flow rate from a fluid source. The drops are indirectly sensed by piezoelectric means mounted on a drip chamber when the drops impinge on a fluid surface in the chamber. The chamber can include a second differential piezoelectric sensing element, which provides a noise reference signal which can be subtracted from the drop sensing signal. The volume of the fluid drops sensed can be determined. The sensing element can be incorporated in open and closed loop disposable chamber modules which can include both monitoring and occlusion valving functions integral therewith.

Abstract: Equipment for continuous ambulatory peritoneal dialysis in which a solution container is coupled via flexible tubing to a patient's tube that communicates with the patient's peritoneal cavity by means of a catheter, usually a surgically implanted catheter. The equipment includes a flexible, foldable plastic dialysis solution container having a transfer port. A flexible tube having a luer connector at its distal end extends from the transfer port, for connecting to a luer connector carried by the patient's tube. The flexible tube carries a frangible member which normally blocks fluid flow but permits fluid flow after the frangible member is broken. A particulate filter and a manually-operable clamp are in series with the flexible tube.Peritoneal dialysis is accomplished by connecting the luer connector from a fresh dialysis solution bag to the patient's tube luer connector, breaking the frangible member, and opening the clamp on the flexible tubing.

Abstract: Equipment for continuous ambulatory peritoneal dialysis in which a solution container is coupled via flexible tubing to a patient's tube that communicates with the patient's peritoneal cavity by means of a catheter, usually a surgically implanted catheter. The equipment includes a flexible, foldable plastic dialysis solution container having a transfer port. A flexible tube having a luer connector at its distal end extends from the transfer port, for connecting to a luer connector carried by the patient's tube. The flexible tube carries a frangible member which normally blocks fluid flow but permits fluid flow after the frangible member is broken. A particulate filter and a manually-operable clamp are in series with the flexible tube.Peritoneal dialysis is accomplished by connecting the luer connector from a fresh dialysis solution bag to the patient's tube luer connector, breaking the frangible member, and opening the clamp on the flexible tubing.

Abstract: A contamination protector for a medical device, principally for use in surrounding and protecting a connection between a plastic dialysis solution container (10) and tubing (22) carried by a patient practicing continuous ambulatory peritoneal dialysis. The protector is generally cylindrical in shape, and opens and closes much like a "clamshell." The inner wall surface (34) of the protector is adapted to carry a material (36) which holds a sterilizing agent in contact with a medical connection when the protector is in the closed position.

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 sterile connection apparatus is provided for enabling the connection of a first tube to a transfer tube of a medical solution container. The apparatus includes a housing having a cover portion which is adapted for interfitting with a base portion to provide a substantially closed interior volume. The first tube and the transfer tube of the medical solution container are introduced within the interior volume and the housing carries means located therewithin and operable from the outside of the housing for enabling manipulation of one of the tubes. In this manner, the first tube may be disconnected from and/or connected to the transfer tube. Means are provided for sterilizing the tubes within the substantially closed interior volume.

Abstract: A blood reservoir comprises a rigid casing and a perforated tubular member positioned within the casing and extending between the edges thereof. An inlet aperture is at a position at the upper end of the reservoir in communication with the bore of the tubular member while an outlet aperture is positioned adjacent the bottom of the casing exterior to the tubular member. The bore of the tubular member contains first blood-defoaming means, and the tubular member carries a blood filter. In accordance with this invention, second blood defoaming means are positioned about the exterior of the tubular member to dissipate the fine bubbles without interference from the larger bubbles, which have been previously removed by passage through the first blood defoaming means.

Abstract: A touch-contamination protected spike connector is provided for coupling a plastic fluid conduit to a port extending from a medical solution container. The spike defines a longitudinal bore and has an angled tip, and carries a flange which extends outwardly from the spike. A tube surrounds and is concentric with a major portion of the spike, with the tube having a dimension suited for coupling to the port with a snug pressure fit. A spacer is interposed between the spike and the tube. The flange and surrounding tube cooperate to enable the spike to be connected to the port with the chance of bacterial contamination caused by accidental touching of the spike being minimized.

Abstract: A diffusion system for blood including a membrane diffusion device comprising a plurality of blood flow paths positioned in interleaving diffusion exchange relation, with second fluid flow paths positioned on opposite sides of semi-permeable membrane means. The first and second flow paths each communicate with an inlet and an outlet. Heat exchange means having an inlet and an outlet is connected at the inlet thereof to the outlet of the first flow paths. A rigid reservoir, also having an inlet and an outlet is connected at its inlet to the outlet of the heat exchange means. A blood flow circuit is defined through the membrane diffusion device, heat exchange means, and reservoir. The flow circuit defines an essentially constant width, perpendicular to the directions of blood flow, from its beginning to end, to provide a system having good flow distribution in combination with a low pressure drop.

Abstract: A support member for use in a coil dialyzer to support an elongated, tubularly-shaped, semipermeable membrane is disclosed herein. The member is embossed and has generally angularly extending parallel ribs on both sides of the web. The ribs are arranged so that on each side there are high ribs and low ribs positioned between said high ribs. The ribs on opposite sides overlap in such a manner to form an angle varying between 60.degree. and 140.degree.. Furthermore, the ribs are arranged in a pattern wherein there are four short ribs positioned between adjacent pairs of high ribs.