Abstract: The invention of this application relates generally to intravenous (IV) infusion of drugs to patients, and more particularly to aspects of an IV infusion system comprising an infusate cassette and an infusate container. The present invention provides a drug infusion cassette that incorporates a strong vial spike that may be non-metal, a means for sheathing the spike when it is not in use, an anti-free flow device, and other beneficial features such as an air entrainment lockout mechanism, quality assurance tags, stopcocks made of soft materials and means of securing tubing to the cassette with a minimum of individual parts. The drug cassette can be used with an automated spiking mechanism comprising a motorized vial holder that holds a vial. The spike remains sheathed if the drug cassette is not fully engaged with a mating surface of devices such as a pumping unit or a sedation and analgesia delivery system.

Abstract: A medicament dispenser comprising a housing; a medicament container; a dispensing mechanism for dispensing medicament from the medicament container; and a radiofrequency identifier connecting to the housing or the medicament container, in the form of a radiofrequency identification tag comprising: an antenna for transmitting or receiving radiofrequency energy originating from an external remote reader; and an integrated circuit chip connecting with the antenna. The dispensing mechanism may, for example, comprise a valve, with or without a metering chamber, for dispensing aerosol formulations of medicaments, or opening or peeling mechanisms for blister strips or packs for dispensing dry powder medicaments.

Abstract: A surgical fluid collection apparatus includes a housing member defining an internal chamber for collection of body fluids and a holder member releasably couplable to the housing member. The holder member includes an internal penetrating member defining an internal conduit in fluid communication with a fluid outlet of the housing member when the holder member is coupled to the housing member to permit passage of the body fluids therethrough. A collection member is positionable with respect to the holder member to receive the body fluids passing through the internal conduit of the internal penetrating member.

Abstract: The invention relates to a disposable element for a medical treatment device, especially a hemodialysis device. The inventive disposable element comprises a film bag filled with the dialysis liquid that consists of two superimposed flat films or a tubular film with connections for supplying and discharging the liquid. The film bag or the tubular film, in the condition ready for usage, is closed with a first weld on the top end and with a second weld on the lower end and is folded several times parallel to the longitudinal axis that is vertical in the condition ready for usage. The film bag is inserted in a receiving unit that is configured as a shaping dish that has a middle cylindrical section followed by an upper or lower convex section. The inventive disposable element, when combined with the receiving unit, unfolds more easily when being filled and has a lesser tendency to form creases.

Abstract: This invention discloses a donor blood donation and sampling system including a donor needle adapted for drawing blood from a body, a blood collection bag coupled to a blood collection conduit which is coupled to the donor needle, a blood sampling conduit also coupled to the donor needle, and a sampling tube assembly arranged for selectable fluid engagement with the blood sampling conduit and for selectable clamping engagement with at least said blood collection conduit. A donor blood donation and sampling method is also disclosed.

Abstract: A device for treating blood in an extracorporeal circuit comprising a venous blood reservoir having an inlet and an outlet, and a hemoconcentrator having a first inlet connector for the blood to be treated, a second outlet connector for the outflow of concentrated blood, and a third outlet connector for the outflow of the ultrafiltered liquid, wherein the hemoconcentrator is disposed within the venous blood reservoir and the hemoconcentrator and the venous blood reservoir are integrated into a single monolithic assembly, and wherein the hemoconcentrator comprises an enclosure containing structure suitable to concentrate blood.

Abstract: The invention relates to a method for preserving the stability of a hemoglobin blood substitute comprising maintaining the hemoglobin blood substitute in an atmosphere substantially free of oxygen. The method for preserving the deoxygenated hemoglobin blood substitute comprises maintaining the deoxygenated blood substitute in an oxygen barrier film overwrap package, wherein at least one face of the overwrap package comprises a transparent laminate material and wherein at least one other face of the overwrap package comprises a foil laminate material. The preserved deoxygenated hemoglobin blood substitute comprises a deoxygenated hemoglobin blood substitute and an oxygen barrier film overwrap package wherein at least one face of the overwrap package comprises a transparent laminate material and wherein at least one other face of the overwrap package comprises a foil laminate material.

Abstract: The invention relates to a method for preserving the stability of a hemoglobin blood substitute comprising maintaining the hemoglobin blood substitute in an atmosphere substantially free of oxygen. The method for preserving a deoxygenated hemoglobin blood substitute comprises maintaining the deoxygenated hemoglobin blood substitute in an oxygen barrier film overwrap package. In one embodiment, the package comprises a transparent laminate material comprising an oxygen barrier layer and a polyolefin layer, wherein the laminant has a thickness of between about 0.001 and about 0.01 inches (or about 0.0254 to about 0.254 millimeters) and an oxygen permeability of less than about 0.01 cubic centimeters per 100 square inches (or about 0.01 cc per 645 square centimeters) over 24 hours at 1 atmosphere and at about 23° C. The oxygen barrier layer comprises ethylene vinyl alcohol.

Abstract: A container closure device for facilitating withdrawal of a liquid from a collapsible sealed packet is disclosed. The device includes a needle guide and a septum retainer wherein the needle guide is fixable to an outer face of the packet and the septum retainer is fixable to an inner face of the packet in alignment with the needle guide. The needle guide includes a tube for receiving a needle and insures proper alignment of the needle. The septum retainer includes a septum chamber having a septum disposed therein.

Abstract: A fluid transfer system has a holder that is made of a cylindrical member having a closed end and an open end. The closed end has fitted thereto a luer and a cannula that extends into the interior of the holder. The holder has a distal portion that has a first cross section and a proximal portion that has a second cross section. The cross section of the distal portion is smaller than the cross section of the proximal portion. The distal and proximal portions are joined by a shoulder. The fluid transfer system also includes an adapter that is inserted to the holder from the open end of the holder. The adapter has a base having a central opening and a cylindrical tube that extends from the central opening. The diameter of the cylindrical tube is slightly smaller than the diameter of the distal portion and is configured to accept a first type of fluid collection store such as a vacuum tube.

Abstract: A vial having a V-shaped bottom to minimize the amount of medical fluid left in the vial at the end of the fluid withdrawal process. The vial is equipped with a vial access adapter having a fluid withdrawal spike which extends into the V-shaped bottom. The vial access adapter may be vented or non-vented. When the medical fluid is a nuclear drug, the vial and vial access adapter is enshrouded in a protective container containing lead to provide a safety to medical personnel from irradiation.

Abstract: A surgical sponge detection system includes a plurality of surgical sponges (2) having radio frequency identification tags (1) securely attached thereto and a non-optical hand-held reader (40) for detecting the sponges by detecting the tags (1). Also disclosed is a device (30) for automatically counting, weighing, and calculating blood loss contained within, soiled surgical sponges (2) which includes a cabinet with an opening (3) at the top through which sponges (2) are deposited, a reader (6) which scans each sponge (2) entered and determines sponge type from a tag (1) affixed to each sponge (2), and a disposable bag (8) into which the sponges (2) are deposited.

Abstract: A port, a container and a method for accessing a port for injecting or withdrawing a liquid from the container are provided. The port may allow for the administration of, for example, a drug, to a patient and may be located on the container. The port has a septum having a target area. The port also has a support ring in contact with the septum. A cap is provided to protect the septum. The cap has a ring handle and allows for removal and exposure of the target area of the septum. A needle, for example, may be used to penetrate the septum allowing the addition or withdrawal of a liquid or other drug to or from the container.

Abstract: A multi-layered tube composed of at least two layers, each formed from a different resin, e.g. resin (I) or resin (II). Resin (I) contains 5 to 40 mass % of a polypropylene resin and 95 to 60 mass % of at least one hydrogenated copolymer. Resin (II) contains 45 to 100 mass % of a polypropylene resin and 55 to 0 mass % of a hydrogenated copolymer. The multi-layered tubes may be used in the field of medicine and provide tubing which is excellent in transparency, flexibility and anti-kinking properties, and which is durable during sterilization procedures with high-pressure steam. The multilayer tubing may also be safely disposed of as it generates no toxic gases, such as dioxin, when incinerated. The multilayered tubing has excellent connectability and may be bonded to other tubing using hot solvent bonding or solvent adhesion. The multilayered tubing which is free from generation of any toxic gas when incinerated, and which is excellent in hot solvent bonding or solvent adhesion to other tube.

Abstract: A combination of a storage container for an injectable product and a needleless injection device for injecting the product, wherein an adapter is used to establish a fluid connection between the storage container and the injection device, wherein the storage container is connected to a dosing means for dispensing the injectable product to the injection device in doses, and the dosing means includes an actuator arranged in the storage container or reaching into the storage container.

Abstract: A blood collection needle assembly includes a holder body having a tube receiving chamber and a needle receiving chamber. A proximal needle is mounted to the holder body and projects into the tube receiving chamber. A distal needle is slidably mounted in alignment with the needle receiving chamber. A spring is provided to urge distal needle into the needle receiving chamber, and a trigger is provided for selectively permitting or preventing proximal movement of the distal needle. A transverse passage between the two needles is formed from a transparent material and provides indication of venus axis. The blood collection needle assembly is used to collect a sample of blood in a conventional manner. After collection of the blood, the trigger is actuated to release the distal needle and the spring propels the distal needle in a proximal direction for safe shielding within the needle receiving chamber of the holder body.

Abstract: The present invention provides a receptacle for a therapeutic fluid susceptible to deterioration on exposure to a gas such as oxygen or carbon dioxide. The receptacle has walls of sheet material each including at least one layer forming a barrier essentially impermeable to such gas, and a seal sealing the walls together in a region thereof. A transfer tube is sealed in the seal having a proximal end in the receptacle, a distal end accessible from outside the receptacle, a flow passage extending between said proximal and distal ends, and a closure blocking flow through the flow passage adapted to be pierced by a tubular needle for transfer of therapeutic through the needle. The transfer tube and closure are essentially impermeable to said gas.

Abstract: An obturator prevents the tips or flaps of a duck-bill valve from self-adhering during storage or during sterilization procedures. The obturator holds the tips apart until the end-user is ready to use the valve. The duck-bill valve is used as an air outlet valve in blood reservoirs.

Abstract: The invention consists of a tube syringe holding device for blood collection and for producing vacuum into the tube which target is to enable the collection of blood, that can be manufactured in a light material where two bodies, one of them cylindrical and the other semi-cylindrical, both hollow and of the same length, form one structure. Its bottom ends are opened. The top end of the cylindrical body is continued by a conduit with a male luer adapter, and the top end of the semi-cylindrical one is continued by two conduits with threads.

Abstract: This invention relates to medical devices containing melt-processible polytetrafluoro-ethylene (PTFE) and methods of making same.

Abstract: The invention relates to a centrifuge provided with a blood bag system having an upper and lower outlet for separation of blood constituents, containing a rotor which can be driven in a rotative manner about a hub, wherein at least one conventional whole blood bag equipped with an upper outlet and with a lower outlet can be positioned vertically in this blood bag, while the whole blood bag can be arranged on the rotor in such a way that one outlet of the whole blood bag is bent in a radial direction, and the opposite outlet of the whole blood bag is bent in the other radial direction, so that the entire whole blood bag and the outlets thereof adopt an approximately Z- or S-shaped form in its functional position. In this case it is preferred that the upper outlet of the whole blood bag lie radially toward the interior and the lower outlet of the whole blood bag lie radially toward the exterior of the whole blood bag.

Abstract: A method of sealing a cartridge having a barrel with a polymeric closure, wherein the polymeric closure includes a tubular collar portion and an integral radial portion, The method includes disposing the tubular collar portion over the radial rim portion of the barrel to surround the reduced diameter neck portion and incrementally rolling and radially deforming the tubular collar portion adjacent its free end into the reduced diameter neck portion with a crimping tool, wherein the polymeric closure is sufficiently malleable to permit radial deformation, yet sufficiently rigid and resistant to creep to retain its shape following deformation The crimping tool or tools include an inclined surface having a gradually decreasing angles of inclination which are driven against the tubular collar portion adjacent the free end and the cartridge assembly and crimping tool are relatively rotated.

Abstract: A method of manufacture for a drug cartridge assembly. The method includes providing a drug cartridge, providing a nozzle sub-assembly, and sterilizing the drug cartridge and nozzle sub-assembly. The method further includes assembling the drug cartridge and nozzle sub-assembly together in a configuration that enables ejection of liquid out of the drug cartridge through the nozzle sub-assembly. The method further includes filling the drug cartridge with a liquid, such as an injectable drug. The method may include separate sterilization of the drug cartridge and nozzle sub-assembly, using different sterilization processes. Portions of the method may be performed prior to sterilization within a first cleanroom, with subsequent steps being performed in a second cleanroom having a substantially lower particulate-per-volume rating than the first cleanroom.

Abstract: A connector device is disclosed for establishing fluid communication between a diluent container having sidewalls and a drug vial. The connector has a piercing member having a first end and a second end and a central fluid pathway. The piercing member is mounted to the liquid container and has fluid accessing portions hermetically sealed from an outside environment. A vial receiving chamber is associated with the piercing member and is dimensioned to connect to the vial. The vial may be selectively attached to the device without piercing the closure of the vial and without breaching the hermetic seal of the fluid accessing portions of the piercing member. Means are provided for connecting the vial receiving chamber to the liquid container.

Abstract: The invention relates to a reservoir (100) for dispensing free-flowing substances, which comprises the following features: (a) reservoir (100) has flexible reservoir walls (2 and 3); (b) reservoir walls (2 and 3) are one-piece or connected to one another; (c) reservoir walls (2 and 3) form a sealed container, which has at least one opening (12); (d) reservoir walls (2 and 3) are connected at least partially to at least two flat standing elements (6), which are separated in the standing area of reservoir walls (2 and 3); (e) opening (12) has a closure (13), whereby at least portions of reservoir walls (2 and 3) and/or standing elements (6) consist of a composite material, which (i) consists of plastic laminates, or (ii) consists of at least one plastic laminate and an aluminum laminate, here, the laminates are connected to one another. Reservoir (100) is provided preferably to accommodate contrast media.

Abstract: The present invention provides methods and devices for maintaining the integrity of blood products throughout preparation, processing and application to a patient or desired site. Coding methods are incorporated onto or into processing and delivery containers which coding methods contain information identifying the donor and/or recipient. Additionally or alternatively the coding methods may contain information pertaining to a specific preparation or application process to be carried out. Blood product processors and blood product applicators include decoding methods to ensure the blood product is administered to the appropriate recipient and further that it has been prepared and applied according to desired processes.

Abstract: A vial having a V-shaped bottom to minimize the amount of medical fluid left in the vial at the end of the fluid withdrawal process. The vial is equipped with a vial access adapter having a fluid withdrawal spike which extends into the V-shaped bottom. The vial access adapter may be vented or non-vented. When the medical fluid is a nuclear drug, the vial and vial access adapter is enshrouded in a protective container containing lead to provide a safety to medical personnel from irradiation.

Abstract: The present invention makes it possible to realize a chemical reaction cartridge, which enables prescribed protocols to be achieved easily without differences among operators, which is sealed and disposable, and which has a safe structure against viruses or dangerous drugs.

Abstract: The present invention has for its object to provide a vacuum sampling tube which is capable of preventing a pretreating reagent accommodated in the vacuum sampling tube from entering the blood vessel and the like even in the event of a backflow of a specimen, such as blood, during vacuum sampling, such as vacuum blood collecting, and a vacuum sampling method.

Abstract: Liquid pharmaceutical compositions stored in glass containers, (particularly of blood plasma proteins such as albumin) having a shelf-life in excess of 18 months; over which time the aluminium content is maintained below 200 micrograms per litre. This is achieved by silicone-coating the glass container. Also the particles/ml post-autoclave and post-pasteurisation are kept to low levels.

Abstract: The present invention is a container for an IV aqueous solution of a Gram-positive oxazolidinone agent, such as linezolid a the compound of formula: which comprises having the container-solution contact surface material be a polyolefin.

Abstract: A fluid flow control device adapted to control the flow of fluid from a fluid container to a fluid extraction device without the need for a needle. The fluid flow control device includes a connector element and a container insert member which define a fluid channel. A compressible valve element is disposed in the fluid channel of the connector element and the container insert member. The valve element includes a plug and shaft and resiliently prevents the flow of fluid by forming a fluid seal in the fluid channel. The valve element may be operationally engaged by the fluid extraction device thereby breaking the fluid seal and allowing the fluid to flow from the container to the fluid extraction device.

Abstract: The invention is an improved container for collecting, freeze-drying, storing, reconstituting, and administering biological solutions and, in particular, blood products. The container features a pliable bottom wall providing intimate thermal contact with the cooling/heating shelf of the lyophilizer; a top wall incorporating a hydrophobic membrane providing a path for water vapor and a bacterial barrier; and side walls sufficiently stiff to support the ceiling but preferably also sufficiently flexible to collapse and minimize storage space especially once lyophilization is complete. The walls incorporate sealable ports that can be used to load the solution for processing and/or adding reconstituting liquids and/or administering the reconstituted solution to a patient. The top wall may incorporate a removable cover that protects the membrane before freeze-drying takes place.

Abstract: A packaged ocular irrigating solution bag, which comprises a gas-permeable plastic multiple compartment bag and a gas-impermeable plastic packaging member for packaging the bag and in which an oxiglutatione-containing solution or solid preparation is enclosed in one compartment and a bicarbonate ion solution is enclosed in another compartment and the space between the bag and the packaging member has a carbon dioxide gas atmosphere.

Abstract: A motor vehicle includes an assistance device for assisting in a diagnosis, therapy and/or prophylactic treatment on a person who is in the vehicle. An electronic data processing device is for automatically actuating and/or interrogating the assistance device. The assistance device can automatically activate at least one device intended to prompt the person to perform an action, e.g. to take medicaments or to perform a physiological exercise. There can also be an identification device for identifying the person, in order to actuate and/or to interrogate the assistance device on the basis of the result of the identification of the person.

Abstract: A portable hand-held blood sampling device having a self-filling capability includes a blood separation filter. The filter has a plurality of pores sized to permit passage of selected blood constituents such as blood plasma through the device. The device has a separated blood conduit that extends beyond the outlet of the device and is shaped for easy penetration into a self-sealing septum of a blood analyzer. An annular shield extends from the device outlet beyond the conduit to prevent inadvertent contact of the conduit by a user.

Abstract: The invention concerns a transfer set in particular for delivering a mixture of liquids for medical purposes, from a so-called flexible main bag (1) containing a first liquid and from at least a so-called auxiliary bag (2, 3) containing a second liquid, capable of being connected to the main bag through a pair of Luer-Lock connectors (8) respectively male and female. The invention is characterised in that each of the two connectors (8) comprises, at one end, a frangible section (10, 17) engaged in the end of a tubing (6, 4) connected to one of the bags (1, 2, 3) and, at the other end, means for being coupled to the other connector, provided with means for locking said connectors in coupled position. The invention is useful for delivering liquids for medical purposes.

Abstract: A syringe safety device coupling between a vial and a syringe, including a tubular connector having a first axial end receiving the vial and a second, opposing axial end releasably receiving a syringe. The tubular connector encloses a sliding joint having opposing open axial ends and a passageway between the ends. A first sliding joint end is adapted to engage a syringe needle. A second sliding joint end is configured to releasably engage a needle receiver. The syringe is releasably removable from the sliding joint after fluid coupling with the vial through the sliding joint, without removal of the needle or the sliding joint from the connector, which captures the needle with the sliding joint in the connector. The first end of a joint includes a receiver, adapted to releasably receive a removable syringe needle, and a mount, adapted to releasably receive a releasable needle receiver of a syringe.

Abstract: A method and device for keeping infusion fluids warm in which not only an infusion bag but also a tube extending from this and a cannula attached to the end of the tube are surrounded by a continuous heat-insulating cover, which heat-insulating person into whom the cannula is inserted.

Abstract: A biological fluid collection system including a collecting device, a collecting container, a first channel connecting the two, a sampling bag, a second channel connecting the sampling bag and the first tube and at least one substantially irreversible closure device in an open position on at least the first or second channel. The biological fluid may be blood. A method of collecting biological fluid such as blood using the system so that fluid in the sampling bag is substantially irreversibly prevented from entering the collecting container.

Abstract: A powered hand-held device (200) for use in stripping blood-lines is disclosed comprising a body (202) housing a battery (206) in a handle portion (204) thereof and housing a first motor (210) in a head portion (208) thereof. A pair of rollers extends from the head at an angle to the handle and is drivingly connected to the motor (210) by a drive mechanism (212). One of the rollers (220) is an idler and is mounted on a support member (222) adapted for lateral movement in the head (208) so that it can be moved toward and away from the other roller (not shown). Support member (222) is driven by an actuator including a second motor (214) that rotates a gear (218) which engages a toothed rack (226) on support member (222).

Abstract: The present invention provides an improved dialysis solution. The improved dialysis solution provides for the use of specific polypeptides as an osmotic agent with an additional osmotic agent such as dextrose. To this end, the present invention provides, in an embodiment, a peritoneal dialysis solution comprising as osmotic agents approximately 0.25 to about 4.0% (w/v) polypeptides and approximately 0.5% to about 4.0% (w/v) dextrose. The polypeptides have well defined characteristics.

Abstract: A sampling apparatus is disclosed that includes a sample container including at least one wall defining a fluid-receiving interior chamber and including a fluid inlet for receiving fluid into the chamber and a sample device receiver carried by the container wall and in fluid communication with the chamber, the receiver being adapted to receive a sampling device for withdrawing a fluid sample from the chamber.

Abstract: A blood collection tube holder assembly is disclosed that includes a needle assembly including a piercing end and a non-piercing end and a generally cylindrical housing including a distal end engageable with the needle assembly, a proximal end adapted to receive a blood collection tube, and a sidewall extending between the proximal and distal ends. A cover is movably associated with the proximal end of the cylindrical body and movable between a closed position covering the proximal end and an open position opening the proximal end.

Abstract: A method for collecting blood from identifiable groups wherein, the steps include: identifying a potential donor pool having common characteristics, identifying a specific stimulus to induce individual donors in the pool to donate blood, presenting the stimulus to the donors, creating a database including the names and addresses of the donors responding to the stimulus, matching the responding donors with geographically favorable collection centers, identifying active donors who donate blood at the collection centers, reinforcing the stimulus to the active donors, and periodically reminding the responding donors including the active donors to donate blood.

Abstract: A method and apparatus are provided by which a fluid may be drawn and packaged within a series of interconnected sterile units. Once filled with the fluid, the connectors joining the sterile units may be sealed and severed to produce a number of separate sterile units. The volume of the separate sterile units may correspond to a single dose of the fluid. The technique allows a fluid to be partitioned into sterile units without exposure to the air or other potential contaminants.

Abstract: A vial access transfer set for use with a bottle containing a medicinal fluid that provides a mechanism for securely attaching an administration set to the bottle and also provides a universal spike port to which any primary IV line can be readily attached. The vial access transfer set includes a novel, vented vial access adapter to which a length of tubing can be connected, the adapter comprising a top wall, a cannula connected to the top wall and a uniquely configured, resiliently deformable slitted skirt connected to the top wall and extending therefrom. With this construction, during the interconnection of the vial access transfer set with the bottle, the rubber septum of the bottle can readily be pierced by the cannula and the resiliently deformable skirt positively snapped into place over the neck portion of the drug vial or bottle to maintain the adapter in secure connection with the bottle.

Abstract: A single-use system for separating blood and producing platelet concentrates includes an elongated container for receiving blood from a patient. The container has a movable plunger mounted within the blood container for expressing blood fractions separated during centrifugation of the container through a first port mounted at one end of said container, a second port mounted on the plunger, and a third port mounted on a plunger rod attached to the plunger.

Abstract: The present invention relates to a method for producing interleukin-1 receptor antagonists, a prophylatically or therapeutically effective protein. A syringe is filled with a body fluid and incubated. The prophylatically or therapeutically effective protein is then produced in the body fluid.

Abstract: The present invention provides a biochip comprising, in sequence from one end of a blood collection bag formed into a flat, pouch-like shape using a flexible material: