Abstract: A system compact enough to be located entirely beside the donor's chair, and able to process the blood while the donor is still resting in the chair after having donated the blood. The separated blood components (plasma and red blood cells) may be stored in their individual optimum environments immediately after the whole blood is drawn, and the blood does not need to be transported back to a separation laboratory for processing. The system includes a needle (72) (or other cannula-like device) for insertion into a vein of the donor and drawing whole blood therethrough, a rotor (2a) for holding the blood after it is drawn, and a motor (50) for spinning the rotor so as to cause the blood to separate into components, for example, plasma and red blood cells. The system also provides for a container for collecting a separated component.

Abstract: Method of treatment by centrifuging of a liquid packaged in flexible-walled bags connected to at least one filter. According to the method, the filter (2) is placed in the middle of the confinement space (5, 5a) such that the large faces of the filter (2) are parallel to the centrifuging axis (3), and bags (1) are placed on either side of said filter (2) so that they are in contact with the latter.

Abstract: A system for collecting and processing donated blood comprises a first porous medium interposed between a blood collection bag and a satellite bag and a second porous medium interposed between the blood collection bag and another satellite bag. The porous media are leucocyte depletion media. The system may also include one or more of the following: a red cell barrier medium, a separation medium, a gas inlet, and a gas outlet. The system can be used to centrifuge whole blood into one or more components, and includes a means for protecting the system during centrifugation.

Abstract: Methods and apparatuses for removing unwanted fluid such as gas from a processed blood product are disclosed. Methods include the steps of passing a blood product from a closed first container through a functional biomedical device to produce a processed blood product, flowing the processed blood product and an unwanted fluid from the functional biomedical device to a second container through a conduit, separating the unwanted fluid from the processed blood product in the second container, preventing the flow of the unwanted fluid from the second container through the passage to the functional biomedical device by using a clamp and passing the unwanted fluid from the second container to the first container through an outlet providing fluid communication between the second container and the first container. The outlet includes a barrier medium which allows the passage therethrough of the unwanted fluid but prevents the passage therethrough of the processed blood product.

Abstract: Systems, processes and devices are provided which are useful for testing blood or plasma donations to detect those specific donations which are contaminated by virus above a predetermined level. An apparatus and process is described which forms individual, separately sealed, and connected sample-containing pouches from a flexible hollow tubing segment connected to a fluid donation container. The tubing segment is sealed at spaced-apart intervals along its length, with tubing segment portions in the intervals between the seals defining pouches, each of which contains a portion of a plasma sample. The contents of the pouches are formed into pools which are subsequently tested for virus contamination by a high sensitivity test such as PCR. When a pool tests positive, indicating it is contaminated by a virus, a further pouch is removed from each of the tubing segments used to form the initial pool.

Abstract: A method for preparing platelets comprises the steps of obtaining whole blood from human, preparing platelet rich plasma from the whole blood and then passing the platelet rich plasma through a filter comprising a porous medium having a CWST of at least about 70 dynes/cm, under conditions sufficient to remove in excess of about 99.99% of the leucocytes from the platelet rich plasma, with preparing platelet rich plasma and passing the platelet rich plasma through the filter occurring in an integrally-attached blood bag system within a few hours of obtaining whole blood from human.

Abstract: Systems and methods for separating mono nuclear cells from whole blood rotate a separation chamber about a rotational axis. The systems and methods introduce whole blood into a first region of the chamber during its rotation to separate the whole blood into a plasma constituent, red blood cells, and an interface between the red blood cells and the plasma constituent. The interface carries mono nuclear cells. While conveying whole blood into the first region, the systems and methods collect the plasma constituent in the first region, while also collecting the red blood cells in a second region of the chamber spaced from the inlet region. The systems and methods create, while conveying whole blood into the inlet region, a back flow of plasma constituent along the interface from the second region toward the inlet region. This back flow of plasma maintains a high-relative hematocrit in the second region and a low-relative hematocrit in the inlet region.

Abstract: Apparatus and method for sterile docking two or more plastic bag units 110. The invention generally includes a sterilizable pouch 102 manufactured from an essentially vapor transmission resistant material. Contained within the pouch 102 is at least one plastic bag unit 110 and a predetermined amount of sterile tubing 108 connected thereto. The pouch 102 includes an aperture 104 in one wall or at one seam through which a tube fitting 106 protrudes. The tube fitting 106 has an internal diameter sufficient to permit passage therethrough of the tubing 108 contained within the pouch 102 and connected to the bag unit 110 contained therein. The protruding tubing 108 then may be used for docking with other bag units 110.

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 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: Disclosed is a method for separating a blood material into blood components by centrifugation, wherein when a multiple blood bag unit including a plurality of flexible blood bags (at least one of the flexible blood bags containing a blood material) liquid-tightly connected to at least one leukocyte-removing filter device through flexible tubes in a predetermined order is accommodated in a centrifuge bucket, at least the blood material-containing flexible blood bag or bags are inserted in the centrifuge bucket while placing at least the leukocyte-removing filter device outside of the centrifuge bucket, wherein the leukocyte-removing filter device is directly or indirectly secured relative to the rotor and a center of the filter device is located at a distance from an axis of the rotation shaft which is smaller than a distance between a pivotal axis of the turning of the centrifuge bucket and an axis of the rotation shaft at a portion thereof which has the rotor connected thereto.

Abstract: Disclosed is a leukocyte-removing filter device comprising (a) a casing having an inlet for blood and an outlet for leukocyte-removed blood, which are both located in a top portion of the casing, and (b) a filter medium disposed in the casing so as to divide the internal space of the casing into an inlet-side chamber communicated with the inlet and an outlet-side chamber communicated the outlet.

Abstract: System employing a sterile medical solution containing glucose or glucose polymers, for example nutritional solutions or solutions for peritoneal dialysis, whereby the majority of the solution is packed in a first package, while the glucose or the glucose polymers are separately packed in a second package, whereafter the two packages are heat sterilized. The content of the glucose or glucose polymers in the second package is maintained above 10% by weight, preferably above 20% by weight and most preferably in the order of 40% by weight in order to reduce or totally eliminate the breakdown of glucose. The medical solution after sterilization, mixing and diluting to 1.5% glucose content has an absorbency caused by breakdown products from glucose at 228 nm less than 0.35 and preferably in the order of 0.20 or lower. The medical solution is also defined in that after sterilization, mixing and dilution to 1.

Abstract: A composite of interconnected bags comprises a blood collecting bag, a preserving liquid bag, and a blood plasma bag. The interior of the bag body of the blood collecting bag is divided by a partition strip into an empty space and an empty space of the shape of a strip, with the two empty spaces mutually communicating near the end part of the partition strip. The blood collected in the blood collecting bag is centrifuged. The upper layer of blood plasma resulting from the centrifugation is discharged via a tube to the blood plasma bag. Then, the erythrocyte preserving liquid in the preserving liquid bag is advanced through the tube, the empty space, and a connecting part and added upwardly from below to the concentrated erythrocyte left behind the empty space. The erythrocyte preserving liquid, without being stirred, is allowed to ascend and mingle with the concentrated erythrocyte with the elapse of time.

Abstract: A therapeutic container is provided for use in a closed therapy system. The therapeutic container is a flexible container that has suspending means, that is divided into a first compartment and a second compartment by an isolation zone, that has an outlet member provided with an openable communication passage which permits communication between the first and second compartments, and that optionally has a second openable communication passage at a location proximal to the end of the container on the side of the suspending means, whereby both the contents of the first and the second compartments can be discharged through the outlet member at a constant mixing ratio while mixing them together.

Abstract: A new intravenous fluid delivery system is disclosed. It consists of an inner product containment envelope that is covered on both sides by outer pressure envelopes. The seams of both the inner and outer envelopes are sealed together along their perimeters resulting in the outer envelopes forming a double wall around the inner product envelope. An outlet port is provided for the product containment envelope for removal of the fluids. This outlet port is similar to those found on common IV bags. A second pressure entry port is provided opposite to the outlet port. The second entry port is in communication with both outer pressure envelopes. Thus, as pressure is induced into the pressure entry port, product will be forced out of the outlet port once it is opened. As pressure in added to the outer envelopes, the inner envelope will be compressed, continuously draining the product within the product envelope until it is evacuated.

Abstract: A method and device for sampling biological fluids during collection without opening the functionally closed collection system, thereby compromising the sterility of the collected fluid. A sample bag connected to a fluid line or collection reservoir is filled coincident with fluid collection, then hermetically sealed and physically separated from the collection system using a radio frequency tubing sealer. A vacuum tube collection device is attached to the sample bag to minimize exposure to the fluid during sample handling and processing.

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: Transfusion and perfusion device having two pressure bags communicating via a calibrated pressure-reducing valve, each pressure bag including an inflatable pressure balloon. Each balloon is held in an envelope and has the same shape as its envelope. An inflating device provides for the inflation of the pressure balloon, and a verticalization device ensures verticality of the drip. Both envelopes which hold the two balloons are flexible and are each provided with a sleeve intended to receive a flexible pouch of the perfusion product in such a way that the pressure balloon contained in its envelope may be inflated to a high pressure and therefore may act as a pressing balloon in order to provide the flow rate necessary for life support. The invention is applicable to the medical and veterinary fields.

Abstract: An apparatus for separately storing a first component, such as a drug and for mixing this first component with a second component, such as a sterilized diluent, to form a beneficial agent which can be delivered to a patient from the container containing the second component. The device includes novel means for interconnecting a container, such as a glass vial containing a first component, such as a drug, with a second container such as a flexible bag containing the second component such as a parenteral liquid, and then for controllably ejecting the first component from the glass vial so that it will fall by force of gravity into the second container whereby the first and second components will thoroughly mix under sterile conditions.

Abstract: A flexible, sterile container is provided for sterile storing and mixing of medicaments and liquids which includes a shell with at least one compartment. At least one sterile liquid-containing pouch is in one of the compartments, and a medicament is in the compartment with the pouch or is in a different compartment. The liquid and medicament are mixed together by squeezing the shell and pouch to rupture the pouch to release the liquid for mixing with the medicament just prior to dispensing the mixture.

Abstract: Apparatus and method for sterile docking two or more plastic bag units 110. The invention generally includes a sterilizable pouch 102 manufactured from an essentially vapor transmission resistant material. Contained within the pouch 102 is at least one plastic bag unit 110 and a predetermined amount of sterile tubing 108 connected thereto. The pouch 102 includes an aperture 104 in one wall or at one seam through which a tube fitting 106 protrudes. The tube fitting 106 has an internal diameter sufficient to permit passage therethrough of the tubing 108 contained within the pouch 102 and connected to the bag unit 110 contained therein. The protruding tubing 108 then may be used for docking with other bag units 110.

Abstract: Disclosed is a method for separating a blood material into leukocyte-removed blood component products, which comprises providing a multiple blood bag system comprising a primary bag containing a blood material, a leukocyte-removing filter device comprising a flat casing, and at least one satellite bag, and centrifuging the blood material using a centrifuge cup having the multiple blood bag system accommodated therein, to thereby separate the blood material into blood components, wherein the centrifugation is performed with the filter device being held by a filter device holder having a substantially flat dimension which is disposed in a centrifuge cup so as to extend in a direction perpendicular to an inner bottom floor of the centrifuge cup, and wherein the filter device holder has a recess and the filter device is received by the recess in a manner such that a flat surface of the flat casing of the filter device is perpendicular to the inner bottom floor of the centrifuge cup.

Abstract: A device for processing donated blood comprises a porous medium interposed between the collection bag and a satellite bag into which a component separated by centrifugation can be expressed, the filter element preferably having a CWST of about 70 to about 115 dynes/cm. The porous medium blocks red blood cells, but allows platelets to pass therethrough.

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 multicompartment system for accumulating a human fluid specimen for analysis having a plastic container for holding the specimen with the container having a port opening for receipt of the specimen, means for mechanically sealing the container including a sealable cap, a heat seal, or a plug, with the specimen therein wherein the seal is effected after receipt of the specimen and can include formation of more than one sealed compartment for subsequent separation and analysis and at least one of the sealed compartments having a rigid or semi rigid element therein protruding from a hole in the compartment to dispense the specimen contained therein therefrom, and said system container also having identification elements capable of inscription thereon.

Abstract: The present invention provides a stopper device comprising a stopper-support structure having a passage inside and a stopper accommodated in the-passage so as to block the passage but movably in the passage, as well as an apparatus containing the stopper device, used for mixing of two components. The stopper device can be penetrated with a connecting device with no edge and therefore generates no debris during penetration and reliably prevents leakage of container contents.

Abstract: A container device comprises a blood-collecting bag, a platelet conserving bag, and a plasma bag. These bags are connected each other by tubes. Anticoagulant agent is contained in the blood-collecting bag, and the other bags are empty. The blood-collecting bag is formed of flexible polyvinylchloride. The blood-collecting bag is autoclaved after containing anticoagulant. The other bags are formed of polyolefin such as EVA, and radiation- or gas-sterilized in an empty state.

Abstract: A method of preparing platelets for long term storage comprises the steps of (a) obtaining whole blood from a human, (b) preparing platelet rich plasma from the whole blood and (c) then passing the platelet rich plasma through a filter under conditions sufficient to remove substantially all leucocytes from the plasma, with steps (b) and (c) occurring in an integrally attached blood bag system within a few hours of step (a).

Abstract: Device and method for dosing a liquid product from a tubular container are provided. The container includes a plurality of doses of the liquid product and a plate for pinching the container together locally such that it is divided into a plurality of separate liquid chambers containing a desired dose.

Abstract: An apparatus for separately storing a first component, such as a drug and for mixing this first component with a second component, such as a sterilized diluent, to form a beneficial agent which can be delivered to a patient from the container containing the second component. The device includes novel means for interconnecting a container, such as a glass vial containing a first component, such as a drug, with a second container such as a flexible bag containing the second component such as a parenteral liquid, and then for mixing the components under sterile conditions.

Abstract: An apparatus is provided for separately storing and selectively mixing a first component, which is in a liquid form, and a second component. The apparatus is formed of a first container made of a flexible material, having a communication mouth with an isolator and adapted to store the first component therein, a supporting case connected to the communication mouth, a second container having a mouth portion held in the case and a plug fitted in the mouth portion and adapted to store the second component, and a hollow, inflexible communication device capable of penetrating through the isolator and the plug. The communication device is accommodated in the first container and is attached to the communication mouth movably therein.

Abstract: A flexible container for packaging liquid and powder components that are to be mixed within the container to form a bone cement comprises a divider for dividing the container into first and second compartments and for isolating the components from one another, the first compartment containing the liquid component and the second compartment containing the powder component under vacuum, and a vacuum reservoir in communication with the second compartment, the vacuum reservoir being of sufficient size to receive substantially all residual interstitial gases from the powder component and thereby ensure thorough admixing of the liquid and powder components upon release of the divider.

Abstract: A bag is disclosed for the collection, freezing, storage, and rapid thawing of fluids, and particularly blood and blood components. Front and back sheets of fluid impervious material are bonded to one another along edge portions thereof to form a bag defining a reservoir. The front and back sheets are further bonded together at a plurality of locations intermediate the edge portions to constrain the distance by which the front and back sheets can separate. The intermediate fastening locations are disposed to permit uniform filling of the reservoir. A port is provided for introducing and discharging fluid into and out of the reservoir. When a fluid is introduced into the reservoir, the front and back sheets are constrained from separating in response to a pressure exerted by the fluid by the intermediate fastenings between the front and back sheets to constrain the thickness of the bag.

Abstract: Processes and systems for combining multiple units of a biological fluid in independent containers into a single container are disclosed.

Abstract: A multiple bag comprising a plurality of bags including a chemical containing bag charged with liquid chemical and at least one vacant bag, wherein the inner surface of the chemical containing bag is less rough than that of the vacant bag.

Abstract: A portable infusion device assembly, having two pouches in pressure transmitting relationship, the first containing infusate and the second, a driving medium. The driving medium is pressurized by activation of osmotic pump, electrochemical reaction, release of pressurized fluid or gas or mechanical means and the rate of infusion is controlled by a rate controlling means. The infusate pouch is separately manufactured and can be stored apart of the rest of the system.

Abstract: A bag for transferring fluid from a source of fluid to a fluid delivery system including three sheets of flexible material joined to form first and second adjacent compartments. Fluid is transferred into the first compartment via a perforated tube connected to the fluid source at a first end. The tube extends into the first compartment and is further connected to the fluid delivery system at a second end. The second compartment may be selectively inflated to exert force on the first compartment and control the rate of fluid flow through the tube to the delivery system.

Abstract: The present invention provides an improved method and container for filtering a body fluid. The method comprises the steps of isolating a volume of solution in a first chamber of a container; collecting a body fluid in a second chamber of a container; passing the body fluid through a filter; and rinsing the filter with an isolated volume of solution.

Abstract: The present invention pertains to an apparatus for containing material produced by a patient. The apparatus is comprised of a container having a first portion with a first cavity within which the anatomical material is held and an opening through which the anatomical material is provided to the first cavity. The apparatus is also comprised of a second portion with a second cavity in communication with the first cavity, and a removable seal disposed between the first cavity and the second cavity. Additionally, the apparatus is comprised of an immobilizing material disposed in the first portion, which when the seal is removed between the first cavity and second cavity mixes with patient material and immobilizes it. The present invention also pertains to a method for collecting anatomical material produced by a patient. The method comprises the steps of placing or collecting the anatomical material into a first cavity of a first portion of a container.

Abstract: A closed system for flushing an IV site comprises a unitary reservoir assembly of a first fluid reservoir for containing a first flush fluid, a second fluid reservoir for containing a second flush fluid, a tubing array for connecting the first and the second reservoirs to an IV site comprising a common tube having a connector on one end thereof for connection to the site, and mounted in a housing having depressible panels for selectively controlling the flow of a fluid from each of the first and the second reservoirs.

Abstract: A container for housing a beneficial agent that can be removably coupled to a structure defining a fluid flow path. The container comprises a body defining a first and second interior area separated by a wall that terminates at an opening providing fluid communication between the first and second interior area. A cannula is provided that extends from the body for being removably received by the structure defining the fluid path. The cannula includes an inlet opening and inlet fluid flow path and an outlet opening and outlet fluid flow path. The inlet fluid flow path being in fluid communication with the first interior area, and the outlet fluid flow path being in fluid communication with the second interior area. The second interior area houses the solid beneficial agent and allows fluid that flows through the inlet fluid flow path to pass by at least a portion of the beneficial agent.

Abstract: A generally flat, elongated edge-sealed polymeric blood bag having a length to width ratio of at least 2 to 1 and one end portion in tapering communication with a connected single tubing which in turn is in closed communication via a Y-connector with both a bag access port and at least one other Y-connector. The second Y-connector is in closed communication with at least one auxiliary bag, preferably two auxiliary bags. Once the upper neocyte portion is expressed from the elongated blood bag the lower, more dense gerocytes can be saved in the original elongated bag or expressed into another connected bag via the Y-connector assembly for subsequent use or storage. The bag system is especially useful for separating and isolating both components of a neocyte/gerocyte red blood cell mixture in an open system and for providing a means for saving the otherwise discarded gerocytes for subsequent use.

Abstract: A blood collecting and filtering apparatus comprises a container (1) defining with a removably fixed cover (2) a tightly closed enclosure. The cover (2) is provided with an adjustable device (6) for connecting to a reduced pressure system and has a traversing opening (4). A disposable flexible filtration bag (10) is disposed in service position inside said enclosure. The bag has two internal rooms (13, 14) separated the one from the other by a filtering wall (12). The first room (13) is connected to the outside by an inlet pipe (15) for feeding blood to be treated, and the second room (14) is connected to the outside by an outlet pipe (16) for filtered blood. The second room has an opening which is closed by an element (17) made of a material which is permeable to air and impervious to liquids. Both inlet (15) and outlet (16) pipes pass in a tight manner through a plug (21) which in service position closes the traversing opening (4 ) of the cover (2).

Abstract: Systems and methods of collecting blood cells use a first container connected to at least three transfer containers. A filtration system is provided with one transfer container, which ultimately serves as the storage container for red blood cells free of white blood cells. The two other transfer containers are connected to each other, one of which is empty and one of which contains and additive solution for storage of red blood cells. The empty transfer container is used for storage of platelet concentrate, while the container that originally contained the additive solution is ultimately used to store the platelet-poor plasma component. A portion of the additive solution may be separately passed through the filtration system after filtration of the red cells to flush additional red blood cells from the filtration device.

Abstract: An aqueous composition for reducing pain at the site of injection of local parenteral anesthetic material, for improving the onset thereof, and for increasing its duration, and a means for preparing and dispensing the same, the composition containing a local parenteral anesthetic which in normal doses gives an acid pH of from about 2.5 to about 6.9, wherein the anesthetic comprises from about 0.5 to about 2.0% by weight of the composition, the composition further containing sufficient NaHCO.sub.3 to maintain the pH thereof between about 7.0 and about 7.6, and further containing from about 0.0004 moles of dissolved CO.sub.2 per ml of composition up to the saturation level of dissolved CO.sub.2 at a CO.sub.2 head pressure of up to about 2.5 atmospheres.

Abstract: An improved multi-chamber intravenous bag apparatus including a collapsible bag forming a chamber of substantially non-reduced cross-dimension along the entire bag. The device includes a pinching mechanism extending across the entire bag to create two subchambers, such mechanism preferably having interengageable male and female members. Fluid may be added to each subchamber and combined upon removal of the clamp. The device promotes quick, efficient, and economical fixing and administration of fluids.

Abstract: The invention concerns the collection of a biological fluid specimen. Both an apparatus and method of collection are described. The apparatus includes an optically transparent plastic bag having a sealable collection port. The bag may be sealed into at least two separate subcompartments. After sealing, the subcompartments are to contain substantially identical fluid specimens. The bag further includes a displaceable element for selectively dispensing and drawing fluid into the system.

Abstract: A system and method is provided to handle the fluids issuing from a patient's bladder after a prostate operation utilizing continuous bladder irrigation eliminating any antireflux valve system and connecting a ten liter overflow drainage bag of at least ten liters in capacity or a pair of bags directly to the drainage spout of the standard urinary drainage bag providing a closed system with open drainage all the way to the overflow drainage bag.

Abstract: Dialysis solutions for hemodialysis and the like, are prepared by addition of sufficient acid to lower the pH of a sodium carbonate solution to less than 7.6 under conditions which will retain the carbon dioxide generated by such acid addition and mixing the thus produced solution with a solution of the other ions required in such a dialysis solution, again under conditions which will retain the carbon dioxide, to provide a dialysis solution which, under working conditions, will not cause finely divided precipitates of calcium carbonate to form.