Abstract: Methods and systems for preparing blood products that are ready for treatment in established pathogen inactivation procedures are disclosed. The methods include providing a source of a blood component and combining the blood component with a synthetic medium in a selected ratio of the blood component to the synthetic media, whereby the resulting blood product is treatment-ready.

Abstract: In one exemplary embodiment, an automated medication preparation system including automated syringe preparation that involves reconstitution of the medication is provided.

Abstract: Filter cartridge assemblies and housings are provided and include a tubular housing having an inner wall, an outer wall, a first end, and a second end. The housings include inner walls with shoulders or other radially-inwardly extending flow directors at the intersections of adjacent sections of the tubular body. The assemblies include a plurality of filter media sections within the housing, and each of the plurality of filter media sections preferably has a different filter media composition. One or more of the filter media sections traverses one or more of the shoulders or other radially-inwardly extending flow directors such that the flow directors evenly direct the flow of fluid through the assembly. The assemblies find particular applicability in dialysis systems.

Abstract: In one exemplary embodiment, an automated means for withdrawing a syringe plunger a method for just-in-time extension of the plunger to permit filling the syringe with a prescribed dose of medication are provided. The method includes the steps of: (1) inputting a desired volume of the prescribed dose of medication; (2) inputting syringe identifying information; (3) calculating a distance that the plunger is to be extended based on the inputted desired volume and syringe identifying information; (4) calculating drive parameters for a controllable drive that causes extension of the plunger when actuated and ensures that the plunger is extended the desired distance; and (5) controlling the drive in view of the calculated drive parameters to cause the plunger to be extended the desired distance.

Abstract: A connector suitable for connection of at least three different types of containers to administration sets, preferably enteral administration sets, and feeding tubes. The containers contain nutritional feed for administration thereof to various types of patients who require enteral nutrition. In one aspect, the connector comprises three different segments: (a) a first segment for connecting containers having mouths having a relatively large diameter, such as, for example, plastic and glass bottles having mouths having diameters of approximately 40 mm; (b) a second segment for connecting containers having mouths having a relatively intermediate diameter, such as, for example, crown cap bottles having mouths having diameters of approximately 26 mm; and (c) a third segment for connecting containers having mouths having relatively small diameters, such as, for example, flexible pouches having mouths having diameters of approximately 12.5 mm.

Abstract: Flexible impervious bag for medical use containing a pharmaceutical preparation of liquid oxaliplatinum said flexible bag is constructed from plastic materials, with the proviso that any portion to the bag in direct contact with said pharmaceutical preparation of liquid oxaliplatinum does not contain polyvinylchloride-based plastic material.

Abstract: A single housing comprising a diluent inlet, a solution outlet, and a plurality of discrete reagent beds comprising at least one reagent in dry form, wherein said reagent is present in the discrete reagent bed in a proportion sufficient for production of a complete hemodialysate solution.

Abstract: A flexible container is provided for the storage and administration of medical solutions. The container incorporates a transparent front sheet made from a planar layer of a polymer and an opposing rear sheet. The rear sheet is made from a planar laminate layer. The front and rear sheets are sealed together along a common peripheral edge to form a volume enclosure. The volume enclosure is constructed of materials having high oxygen and moisture barrier properties which allows the container thermoplastic to be stored for extended periods of time without degrading the contents. The volume enclosure is then inflated with a pressurized gas to permanently stretch the front and rear sheets outwardly and to thereby increase the volume capacity of the container. An alternative embodiment of the container incorporates multiple compartments, separated by peelable seals, for containing a diluent and a medicament.

Abstract: A fibrin mixture and dispenser assembly is provided for mixing a first protein component with sterile water to form a first protein solution and for dispensing the first protein solution. The first protein solution forms a biological adhesive when intermixed with a second protein solution. The second protein solution is preferably mixed and dispensed by a similar fibrin mixture and dispenser assembly. The two fibrin mixture and dispenser assemblies can be housed within a single housing. The assembly includes a piercer and a first tubular extension having grooves for providing fluid communication between a reservoir and a mixing chamber or a vial. The reservoir is also in fluid communication with a dispensing needle through a second tubular extension. The reservoir is configured to contain water which is introduced to the mixing chamber. The mixing chamber is configured to contain the first protein component.

Abstract: A multiple-chamber medical container comprising a container body 3 having two chambers 10 and 11 for storing medicaments and a partition seal 20 separating the chamber 10 from the chamber 11, and an outlet 32 attached to the container body 3 for allowing the medicaments to be discharged from the chamber 11, the partition seal 20 being openable so that the chambers 10 and 11 may communicate with each other at the time of use, wherein the container body 3 comprises a discharge-control seal 21 separating the chamber 11 from the outlet 32 and being openable at the time of use, and the force required to open the partition seal 20 is lower than that required to open the discharge-control seal 21.

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 spike for facilitating the introduction of liquid under pressure into a container containing a substance is provided which includes an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, where the distal end has a sharp, pointed tip. An introduction channel is located within the spike shaft for receiving liquid into the container where a portion of the introduction channel is angled to cause liquid to travel out of the introduction channel in a direction non-parallel to the longitudinal axis of the spike shaft. An extraction channel may be included within the spike shaft for removing liquid from the container, where the extraction channel extends through the elongate spike shaft towards the proximally located end portion.

Abstract: To produce a two-chamber arrangement having a first chamber, which is filled with a first component, and a second chamber, which is filled with a second component, two separate bags are sterilized and filled independently of each other with the first/second component. Only after the bags have been sterilized and filled are they connected to each other in such a way that the component contained in one chamber can be transferred into the other chamber so as to be able to mix the two components together. Once they have been filled, the first and second bags are preferably sealed with an openable peel seam, after which the bag ends are welded together.

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:

Abstract: An article of manufacture is provided comprising a vial having (a) a first chamber that is substantially filled with an injectable pharmaceutical formulation; (b) a second chamber that is substantially empty but for a gaseous medium; (c) a septum, impermeable to the gaseous medium, separating the first and second chambers; and (d) actuating means effective to bring the formulation and the gaseous medium into contact by breach of the septum such that the gaseous medium acts as an effective headspace for agitation of the formulation. The formulation comprises an aqueous medium, a drug in solid particulate form in a therapeutically effective amount suspended in the medium, and one or more wetting and/or suspending agents in an amount effective to provide controlled flocculation of the drug, at least one ingredient of the formulation being susceptible to oxidative degradation.

Abstract: The present invention is a container assembly that includes a coating composition on an interior surface of the container assembly and more particularly a coating composition for rapid clotting of a blood sample within a blood collection tube. The coating composition includes an intrinsic coagulation activator and an extrinsic coagulation activator for activating intrinsic and extrinsic pathways for promoting the rapid clotting of the blood sample. In addition, the present invention includes a barrier package for enclosing the container assembly.

Abstract: A transfer set for transferring fluid, including drugs, vaccines, medicaments, solutions and the like, between a first container, such as a conventional vial, and a second container, such as a conventional syringe having a unique multipurpose resealable member. The transfer set assembly includes an elastomeric tubular fluid transfer and resealable valve member preferably including an open end mounted on the pierceable closure or stopper of a vial and a generally closed distal end having a longitudinal slit and a piercing member is telescopically received within the fluid transfer valve member having a piercing end opposite the pierceable closure. The fluid transfer valve member is preferably formed of silicone and is surrounded by a generally tubular luer connector member having an open end mounted on the pierceable closure and a distal end having male luer threads.

Abstract: The invention concerns a re-forming device in particular for mixing substances in the medical field, comprising a hollow needle (2) pointed at its two tips and fixed on a support (3) defining two coaxial sleeves enclosing each end of the needle and designed to receive, one (8), the plug opening (9) of a vial (10), the other (4), the hub (6) of an injection tube (6) of a flexible bag (7), so as to communicate, by perforating said plug (9) and hub (6), the vial (10) and the flexible bag (7) via said needle (2).

Abstract: A bag arrangement for intermixing two, separately stored substances. The bag arrangement includes a bag having a jacket defining an inner chamber for accommodating a first substance and a piercing device having a chamber in which the jacket is received. A single piercing member is provided on one side of the jacket and a hollow abutment is located opposite the piercing member on an opposite side of the jacket and forms a receptacle for accommodating a second substance. Upon actuation of the piercing device, the piercing member pierces the opposite sides of the jacket providing for intermixing of the first and second substances.

Abstract: A multi-chamber renal dialysis container having at least two compartments and containing concentrated glucose in a first compartment and a hydrochloric acid solution containing electrolytes in a second compartment. The compartments are separated from one another during storage and transportation by separable peel seals, and the solutions can only be mixed with one another by the opening of the peel seals. An outlet of the multi-chamber container is separated by a further peelable seal, whereby a substantially empty third chamber is formed.

Abstract: In a method and a device for filling needle-free injectors, it is proposed that filling takes place through the injector discharge opening and where the piston stopper has been previously inserted. Filling takes place in such a way that, independently of tolerances of the injector, the interior space is filled to the brim in an at least approximately bubble-free manner. It is not absolutely necessary to measure or dose the liquid to be filled. The filled state is either established through the disappearance of the vacuum in the interior space, or through the piston having reached a specific position during displacement.

Abstract: A device for transferring a fluid product from one container to another including a hollow needle suitable for piercing a membrane and having a first, front opening, the needle being connectable to one of the containers via a first, rear hollow needle opening so that the fluid product can be conveyed into or out of the container through the hollow needle and hollow needle openings, the needle having a second, rear opening which forms a fluid connection between the another container and a pressure compensation device or the environment while the fluid is being transferred.

Abstract: The invention provides an apparatus and method for storing and transporting peritoneal dialysate in dry or lyophilized form, and for forming a deliverable peritoneal dialysis solution therefrom. In one embodiment, a dry reagent bed, including reagents sufficient to produce a dialysis solution, is suspended in a diluent flow path through the apparatus housing. Continuous pressure on the reagent bed causes the bed to compact as it erodes when purified water is passed through the housing. The pressure ensures complete and even dissolution of the reagents. Through dry storage and simple dissolution, even in a home, the invention enables a wider variety of solution constituents, including reduced acid content and the use of bicarbonate as a stable buffer component. The latter is illustrated in a double-bed embodiment, where bicarbonate is stored separately from calcium or magnesium salts within a single housing.

Abstract: A single housing includes a diluent inlet, a solution outlet, and a plurality of discrete reagent beds comprising at least one reagent in dry form, wherein the reagent is present in the discrete reagent bed in a proportion sufficient for production of a complete hemodialysate solution.

Abstract: An improved transferset assembly for transferring fluids between a first container, such as a medicament vial and a second container, such as a syringe, which includes an integral polymeric transfer assembly having a tubular collar portion, a radial portion overlying the rim of the first container, an outer tubular portion and an inner tubular portion which is integrally joined to the outer tubular portion by a radial intermediate web portion, a piercing member telescopically received in the inner tubular portion having a piercing end to pierce the closure sealing the open end of the first container and a removable closure which seals the open ends of the outer and inner tubular portions of the transfer assembly.

Abstract: A transfer guard for use by an individual for transferring contents from a supply container into a receiver container includes a supply adapter, a receiver adapter, a support structure and a fluid conducting element. The supply adapter connects the supply container to the transfer guard, and the receiver adapter connects the receiver container to the transfer guard. The support structure couples the supply adapter with the receiver adapter, and supports the fluid conducting element which, passes through the supply adapter and the receiver adapter. The fluid conducting element provides a passage for the contents to transfer from the supply container into the receiver container. The fluid conducting element also includes at least one pointed end that is substantially protected by the transfer guard from contact with the individual.

Abstract: A container cap or a liquid communication adapter attachable to a container mouth having a conventional rubber-like stopper. A container cap includes at least one disk-like valve provided with an insertion hole in a central portion thereof, and a cover for restraining the valve by covering at least an upper periphery of the valve. A lower periphery on a back surface of the valve is supported by a seating portion of a container mouth or a seating portion of a joint that is supported by the container mouth, and the container cap has an anchor for anchoring an insertion member to the cap by using a peripheral edge forming a fitting hole in the cover, while inserting the insertion member into the insertion hole.

Abstract: The invention concerns a connecting device (1) comprising a base (5) mounted on the receptacle (2) and extended by a flange (9) forming an inner bore (A) and a piston (10) capable of sliding in said inner bore (A) between a released position relative to a plug (4) and a transfer position wherein a hollow needle (11) borne by the piston (10) passes through the plug (4). A scaling lip (22) is arranged on an internal surface (8d) of the bore (A) opposite the piston (10) or a surface of the piston, said lip (22) being shaped to be urged to press sealingly against the piston (10d) or against an internal surface of the bore, in the transfer position.

Abstract: The present invention is a container assembly that includes a coating composition on an interior surface of the container assembly and more particularly a coating composition for rapid clotting of a blood sample within a blood collection tube. The coating composition includes an intrinsic coagulation activator and an extrinsic coagulation activator for activating intrinsic and extrinsic pathways for promoting the rapid clotting of the blood sample. In addition, the present invention includes a barrier package for enclosing the container assembly.

Abstract: Disclosed is a device and material which assist in the coagulation and containment of blood from a wound produced as a result of medical procedures which require blood to be drawn, such as with a lancet or a needle or the like. The device is a compact, portable unit that dispenses an appropriate amount of absorbent material for the collection and coagulation of blood. The absorbent material comprises a nonabsorbent backing coupled with an absorbent top layer. The absorbent material may also contain medicaments that assist in the coagulation and wound healing process.

Abstract: Leaktight confinement appliance (1), intended to cooperate with an independent receptacle (3) containing a substance (4), having its own means (8) for transfer into and/or out of the receptacle, and with an independent means (71) for delivery of a material. The appliance includes a handling chamber (2) defined by a wall (13) of flexible material substantially leaktight with respect to the external environment. A pouch is formed within the wall of the handling chamber (2) for retaining an interconnection device. The handling chamber (2) is arranged to connect at least the transfer means (8) of the receptacle (3) to the delivery means (71) through the interconnection device.

Abstract: A vial docking station for simultaneously sliding the spouts of a plurality of liquid medicament vials into an engaged position with matching receptacles of a like plurality of liquid reconstitution diluent bags.

Abstract: The present invention provides methods, compositions and apparati for rapid pediatric resuscitation and/or emergency management. A standardized formulation of each commonly used resuscitation medication is provided so that calculating dosage amounts is simplified. The formulations are standardized to a pre-determined dosage concentration and packaged in containers which may be coded to provide a simple means of separating and recognizing each medication. The standardized medications may be provided in a self-contained set-up along with commonly used medical equipment for use in resuscitation procedures.

Abstract: A device for transferring a fluid product from one container to another including a hollow needle suitable for piercing a membrane and having a first, front opening, the needle being connectable to one of the containers via a first, rear hollow needle opening so that the fluid product can be conveyed into or out of the container through the hollow needle and hollow needle openings, the needle having a second, rear opening which forms a fluid connection between the another container and a pressure compensation device or the environment while the fluid is being transferred.

Abstract: Devices and kits for intracranial and other perfusions and methods of using the same including a container having a top and bottom including a flexible bag adapted to be suspended in top to bottom orientation and to hold, in a main chamber, a solution, suspension or emulsion filled up to a fill line, a first opening to the bag located below the fill line and adapted to be fitted to conduit, a second opening located below the fill line and adapted to be fitted to conduit, and a first fluid pathway incorporated into the bag adapted to conduct fluid pumped into the second opening from below the fill line to an outlet within the bag located above the fill line.

Abstract: One object of the present invention is to provide a medical container with multiple chambers and a production method thereof, where respective medicaments housed in a plurality of chambers can be separated without fail until performing the infusion and when performing the infusion, the respective medicaments can be easily mixed while keeping the sterile state.

Abstract: The invention relates to an apparatus comprising a closure-cap and a container in the form of a two-chamber cartridge in which an active ingredient and a solvent can be stored separately until the apparatus is used in a nebuliser, as well as an active substance concentrate in which the active substance is present as a solution or suspension for storage purposes.

Abstract: A method and apparatus for reconstituting a multiple component material is disclosed. More particularly, the present invention discloses an apparatus utilizing an operator controllable pressurization device to generate a pressure differential between two receptacles attached to the device. The receptacles may contain individual components of a multiple component material, and may include liquid-liquid or liquid-solid compounds. The apparatus includes a material transfer lumen attachable to a first and second component receptacle. A pressurization lumen is connected to one of the component receptacles to facilitate material transfer. One embodiment of the present invention utilizes a negative pressure differential created in the second receptacle to facilitate transfer. In another embodiment, a positive pressure is created in the first receptacle to force material transfer between the two receptacles.

Abstract: The present invention provides devices and methods for stabilizing bicarbonate-based solutions for peritoneal dialysis or hemofiltration. The bicarbonate-based solutions of the present invention are formulated and stored in at least two parts—an alkaline bicarbonate concentrate and an acidic concentrate. The alkaline bicarbonate concentrate is adjusted to have a pH of about 8.6 to 10.0. The acidic concentrate is adjusted to have a stable, acidic pH ranging from about 1.0 to 3.0. Upon mixing, although some variation in the pH of the mixed bicarbonate solution exists, the inventors have discovered that with the appropriate selection of the parameters of the concentrates, the pH of the mixed solution is always within an acceptable physiological range.

Abstract: The present invention relates to an impermeable flexible multicompartment bag for medical use for sterile solutions, and to a method for the preparation of such bags. Impermeable flexible multicompartment bags for medical use for sterile solutions for perfusions, consisting of two welded sheets of a composite material wherein the sheets forming the inner wall of the bag consist of a polypropylene and are bonded to an outer layer of a thermoplastic polymer by means of a polyolefin layer, characterized in that the sheets facing the contents of the bags which are made of a homophase copolymer of propylene are immediately welded in the intercompartment region and in the peripheral region such that the weld forming the intercompartment region can be ruptured with a force in the range of from 10 to 30 N while the weld in the peripheral region cannot be ruptured.

Abstract: A transfer guard for use by an individual for transferring contents from a supply container into a receiver container includes a supply adapter, a receiver adapter, a support structure and a fluid conducting element. The supply adapter connects the supply container to the transfer guard, and the receiver adapter connects the receiver container to the transfer guard. The support structure couples the supply adapter with the receiver adapter, and supports the fluid conducting element which, passes through the supply adapter and the receiver adapter. The fluid conducting element provides a passage for the contents to transfer from the supply container into the receiver container. The fluid conducting element also includes at least one pointed end that is substantially protected by the transfer guard from contact with the individual.

Abstract: A method and apparatus for reconstituting a multiple component material is disclosed. More particularly, the present invention discloses an apparatus utilizing an operator controllable pressurization device to generate a pressure differential between two receptacles attached to the device. The receptacles may contain individual components of a multiple component material, and may include liquid-liquid or liquid-solid compounds. The apparatus includes a material transfer lumen attachable to a first and second component receptacle. A pressurization lumen is connected to one of the component receptacles to facilitate material transfer. One embodiment of the present invention utilizes a negative pressure differential created in the second receptacle to facilitate transfer. In another embodiment, a positive pressure is created in the first receptacle to force material transfer between the two receptacles.

Abstract: The invention provides an apparatus and method for storing and transporting peritoneal dialysate in dry or lyophilized form, and for forming a deliverable peritoneal dialysis solution therefrom. In one embodiment, a dry reagent bed, including reagents sufficient to produce a dialysis solution, is suspended in a diluent flow path through the apparatus housing. Continuous pressure on the reagent bed causes the bed to compact as it erodes when purified water is passed through the housing. The pressure ensures complete and even dissolution of the reagents. Through dry storage and simple dissolution, even in a home, the invention enables a wider variety of solution constituents, including reduced acid content and the use of bicarbonate as a stable buffer component. The latter is illustrated in a double-bed embodiment, where bicarbonate is stored separately from calcium or magnesium salts within a single housing.

Abstract: Leaktight confinement appliance (1), intended to cooperate at least with one independent receptacle (3) containing a substance (4), having its own means (8) for transfer into and/or out of the said receptacle, and with at least one independent means (71) for delivery of a material, the said appliance comprising a handling chamber (2), defined by a wall (13) of flexible material substantially leaktight with respect to the external environment, arranged to connect at least the transfer means (8) of the receptacle (3) to the delivery means (71), inside the handling chamber (2). This appliance comprises a means for leaktight assembly (50) between the handling chamber (2) and the transfer means (8) of the receptacle (3), and a means (70) for leaktight connection between the handling chamber (2) and the delivery means (71).

Abstract: A flexible transparent container for improved storage of oxygen sensitive parenterally administerable agents comprising an inner, primary container enclosed in a substantially oxygen impermeable outer envelope with an oxygen absorber, capable of consuming essentially all residual oxygen after the outer envelope is sealed, and for sufficient period also the oxygen penetrating said envelope. The inner container is made of a polypropylene containing flexible polymeric material compatible with lipophilic agents capable of forming both permanent and peelable seals, while the envelope is made of a substantially water impermeable flexible multilayered polymeric material comprising a first outer substantially water impermeable polymeric film with oxygen barrier forming capacity, assembled with a second, inner polymeric film with a supplementary oxygen barrier forming capacity. The container essentially maintains its characteristics after being subjected to sterilization by steam or radiation.

Abstract: A neutral glucose-containing preparation with excellent stability and a near physiological pH, as a transfusion preparation with minimal glucose degradation by-products and a greatly reduced formic acid content; specifically, a glucose-containing preparation comprising separately housed first and second solutions, the first and second solutions satisfying the following conditions: (a) the first solution contains 2-50% glucose, and its pH is adjusted to 3-5 with an organic acid buffer solution; (b) the second solution contains an alkalizing agent, and has a pH value of 8-13 as a pH adjustor for the first solution; and (c) the glucose concentration is 1-15% in the preparation solution obtained by mixing the first solution and second solution, and the pH of the solution is in a range of 6-8. It is used particularly as a peritoneal perfusate, such as a perfusate for Continuous Ambulatory Peritoneal Dialysis (CAPD).

Abstract: An improved transferset assembly for transferring fluids between a first container, such as a medicament vial and a second container, such as a syringe, which includes an integral polymeric transfer assembly having a tubular collar portion, a radial portion overlying the rim of the first container, an outer tubular portion and an inner tubular portion which is integrally joined to the outer tubular portion by a radial intermediate web portion, a piercing member telescopically received in the inner tubular portion having a piercing end to pierce the closure sealing the open end of the first container and a removable closure which seals the open ends of the outer and inner tubular portions of the transfer assembly.

Abstract: Containers and methods for making containers are disclosed. The containers include a chamber and a pouch fixed within the chamber. During manufacture, the open edges of the pouch are sealed between the walls of the container by a seal defining, in part, the peripheral edge of the chamber.

Abstract: A device is provided for reconstituting a lyophilized or powdered medicament such as blood factor VIII which must be reconstituted just prior to use, such as by introduction of a sterile fluid from a syringe, which comprises a housing having an upper section capable of receiving a syringe and a lower section capable of receiving a vial containing the medicament in co-axial alignment with the syringe, a middle section connecting the upper and lower sections which has a central aperture which forms a passageway for fluid transfer between the syringe and the vial, and a hollow vented spike which extends downwardly from the central aperture for a length sufficient to ensure that the lower end of the spike will pierce the seal and enter the interior of a vial housed in the lower section of the device. The invention is advantageous because the vented opening in the spike will allow for an equalization of the pressure after the piercing of the vial by the spike which will facilitate the use of the device.

Abstract: A solution kit includes a prefilled syringe and a container containing a solvent charged therein. The prefilled syringe comprises a barrel provided at a distal end thereof with a tip closed by a twist-off type closing member, while the solvent container having a mouth portion closed by a twist-off type closing member. The tip of the prefilled syringe and the mouth portion of the solvent container are configured to engage with one another in liquid-tight engagement.