Abstract: Devices for the automatic release of liquid medicaments are disclosed. In particular, a flexible container for storing a liquid medicament, a port for such a flexible container, and a device for the automated release of a liquid medicament are disclosed. A flexible container for storing a medicament comprises sealed top and bottom flexible sheets and at least one port mounted to a wall of the flexible container. The at least one port comprises a flange attached to the wall and an inner conduit connecting the inner storage volume and the exterior of the flexible container. The port comprises an adapter protruding through a hole in the top flexible sheet and a base plate having at least one drain channel connected to the inner conduit via an inner opening on the base plate. A device for the automated release of a medicament comprises at least one flexible container.

Abstract: Vacuum break vial assembly and method for reducing the incidence of nosocomial infections, comprising a vial stopper having a 2-part withdrawn-fluid volume compensation assembly having a barbed vent element that secures an apertured needle sheath, a bladder-retainer tube and an expandable/unfoldable bladder. The vial has an aluminum cap holding a plastic flip-off top that removes a central portion of the cap to permit access by hypodermic needle through the stopper into the needle sheath. No pre-pressurization of the vial by ambient contaminated air via the hypodermic can occur. Rather, the needle is inserted in the vial through the stopper and the medicinal fluid withdrawn. Air is inlet into the separate bladder which expands to permit withdrawal of fluid into the hypodermic without vacuum lock. No air having pathogen vectors is introduced into the vial medicinal fluid as the bladder isolates volume-compensating air from the medicinal fluid. Plural embodiments are shown.

Abstract: Systems and methods handle air and rinsing fluid during fluid processing. The systems and methods eliminate air from a fluid processing system prior to, during, and after use. The systems and methods provide a connector assembly for establishing fluid flow from a fluid source. The connector assembly has discrete first and second passages that prevent communication between the fluid in first passage and the fluid in the second passage. Prior to system use, the connector assembly may be utilized in a priming function to remove residual air from a fluid circuit prior to use. The connector assembly may also be utilized after use to perform a rinse-back function.

Abstract: Apparatus and method for use in the sterile sampling of liquid from a container, the apparatus having a normally vertical tubular sight chamber coupled by its lower end to a sample port assembly. The upper end of the chamber is fitted with an inlet tube through which sample liquid can be received and a filtered vent to allow air to flow to and from the sight chamber while preventing the ingress of bacteria in to the chamber. The sample port assembly has a tubular body encasing a sheathed needle assembly so that evacuated phials can be inserted into the body and pressed onto the needle assembly to withdraw samples of liquid collected in the sight chamber, the sight chamber preferably having transparent walls that are marked with graduations so that each phial can be withdrawn from the needle assembly after the desired amount of liquid has been collected.

Abstract: Provided are pharmaceutical liquid formulations of G-CSF, which are stable over a long time period and substantially free of excipients, as well as ready-to-use syringes containing such formulations and corresponding kits.

Abstract: An automated blood draw system operates in conjunction with an arterial or venous line. The aspiration mechanism allows the rate of aspiration, volume of aspirate, and the time interval of aspiration to be predetermined. Blood can be collected in sequential collection vials for subsequent analysis of a given laboratory parameter, or delivered directly to integrated analysis devices. While a predetermined volume of aspirate can be wasted, excessive aspiration is prevented by monitoring waste obtained in a collection receptacle. A flush system maintains the patency of the line without contamination of the specimen.

Abstract: An apparatus is disclosed that allows for separating and collecting a fraction of a sample. The apparatus, when used with a centrifuge, allows for the creation of at least three fractions in the apparatus. It also provides for a new method of extracting the buffy coat phase from a whole blood sample. A buoy system that may include a first buoy portion and a second buoy member operably interconnected may be used to form at least three fractions from a sample during a substantially single centrifugation process. Therefore, the separation of various fractions may be substantially quick and efficient.

Abstract: A medicine discharge stopper for a medical bag of a type where a multiple of medicines are mixed, aiming to positively exclude a possibility of generation of erroneous operation that administration is done without opening the mixing seal. The medical bag is formed from a soft film and has an inner space, which is divided into compartments 20 and 22. An outlet port 12 is provided so that it is opened to the first compartment 20. The stopper includes split halves, which, when tied, form an inner space 34 of the outlet port 12. The combination is done under a resilient force by cantilever fashioned extending parts 38. When the weak seal portion is opened, an impact-like hydraulic force is generated and the bag is widened, which causes the flaps 30 and 32 to be opened against the resilient force, resulting in a release of the stopper. The flaps 30 and 32 are made separable from the body parts, which allows the stopper to be also utilized for a holder of needle during the execution of infusion process.

Abstract: It is intended to provide an apparatus for separating and storing blood components which facilitates the preparation of serum.

Abstract: A dispensing apparatus and method for dispensing fluid from a container is disclosed. The dispensing apparatus includes a container for storing fluid and a dispensing cap. The dispensing cap includes a bottom portion configured to be attachable to the container and a port connector including a bottom cylindrical end for attaching the port connector through a hole in the bottom portion of the dispensing cap. The dispensing cap also includes a protective cap connectable to a top cylindrical end of the port connector for providing access to the dispensing cap. A dispensing instrument is arranged to be connectable to the top cylindrical end of the port connector to retrieve liquid stored in the container attached to the dispensing cap.

Abstract: Embodiments of the present invention provide a topical anesthetic and antiseptic dispensing device article of manufacture. In an embodiment of the invention, the article of manufacture includes a penetrating instrument including an elongated body with first and second distal end such that at least one of the distal ends includes a penetrating edge. By way of example, the penetrating instrument can be a syringe, an IV catheter needle assembly, a pressurized tube holder configured with a needle for blood draw, or a scalpel, to name a few possibilities. The article of manufacture also includes a container coupled to the elongated body of the penetrating instrument. The container provides at least one chamber. Finally, the article of manufacture includes a nozzle connected to the container and configured to dispense pressurized content of the container responsive to activating a trigger communicating with the nozzle.

Abstract: A freeze-dried material is stored in a first chamber of a container along with a reconstituting liquid for the freeze-dried material, which is stored in a second chamber of the container. A sealing wall within the container forms a barrier between the first chamber and the second chamber preventing contact between the freeze-dried material and the reconstituting liquid. At least one valve assembly in the sealing wall selectively opens a region of the sealing wall to establish fluid flow communication between the first and second chambers, allowing the freeze dried material to be reconstituted. The reconstituted freeze-dried material can be administered from the same container to a recipient.

Abstract: The present invention provides a one-piece bottle containing enteral feeding material and having a top end with a threaded section and a bottom end comprising a funneled connector port; and a threaded cap dimensioned to mate with the threaded section of the one-piece bottle; wherein the funneled connector port connects to an enteral feeding assembly; wherein the threaded cap provides a leak proof seal such that there is no exposure point until it is used for feeding, thereby preventing contamination.

Abstract: Cap adapters for a medicament vial configured to facilitate the transfer of liquid medicament from, the vial and into a syringe. In one embodiment the cap adapter comprises a wall portion with a first lumen passing through it. A vial-engaging portion secures the cap adapter to the vial. A spike extends from the wall portion and defines a second lumen passing through the wall portion. A cone-shaped shield extends from the first lumen. The shield is configured to guide a hypodermic needle toward the first lumen to thereby reduce a risk of needlestick to a user handling the vial. In certain embodiments, a light source cooperates with the cap adapter to illuminate at least a portion of the cap adapter to reduce a risk of needlestick to a user handling the vial in a darkened environment. In certain embodiments, a secondary sealing member abuts a first face of the wall portion and seals an end of the first lumen.

Abstract: Cap adapters for a medicament vial configured to facilitate the transfer of liquid medicament from the vial and into a syringe. In one embodiment the cap adapter comprises a wall portion with a first lumen passing through it. A vial-engaging portion secures the cap adapter to the vial. A spike extends from the wall portion and defines a second lumen passing through the wall portion. A cone-shaped shield extends from the first lumen. The shield is configured to guide a hypodermic needle toward the first lumen to thereby reduce a risk of needlestick to a user handling the vial. In certain embodiments, a light source cooperates with the cap adapter to illuminate at least a portion of the cap adapter to reduce a risk of needlestick to a user handling the vial in a darkened environment. In certain embodiments, a secondary sealing member abuts a first face of the wall portion and seals an end of the first lumen.

Abstract: A method for treating conditions related to lack of blood supply with a resuscitation fluid is disclosed. The resuscitation fluid contains a lipophilic component and a polar liquid carrier. The lipophilic component forms an emulsion with the polar liquid carrier. The resuscitation fluid can be used to increase the blood pressure and to carry oxygen and other lipophilic gases to tissues. The resuscitation fluid can also be used for preserving the biological integrity of donor organs for transplantation.

Abstract: A tamper evident safety seal includes a first band, a second band and first and second arms connecting the first band and the second band. The seal is positioned around a radiopharmaceutical container and further includes a connector assembly having a connector and a break away portion that, when separated, provides visual evidence that the seal has been broken.

Abstract: A method and system for handling hazardous materials contained in a vial includes an isolation enclosure having an opening selectively sealable about the vial, a bag body portion, and a cap portion. A latching extraction element is attached to the cap portion and has a preceding engaging member to secure the vial to the isolation enclosure, an extraction member to be inserted into the vial and remove material therefrom, and a primary engaging member to secure the vial to the extraction member. A valve is mounted outside the isolation enclosure and controls the flow of fluid from the vial. An adaptor having a reseal member permits flow when coupled to the valve and restricts flow when uncoupled from the valve. Once uncoupled, the adaptor is removably associated with a second valve located remotely from the isolation enclosure, allowing fluid to pass into the second valve.

Abstract: The present invention provides a reservoir compartment adapter for use with a fluid delivery device. The adapter includes a first end adapted for coupling with a fluid delivery device, a second end adapted for coupling with a connector, and a structure between the first end and the second end including an interior space for receiving the reservoir, wherein an extended reservoir compartment for accommodating the reservoir is adapted to be formed when the first end is coupled to the fluid delivery device, and the reservoir is adapted to be secured in the extended reservoir compartment when the connector is coupled to the second end. The adapter allows a user of a delivery device accommodating reservoirs of a certain size to manage periods where increased medication dosage is needed without the burden of carrying a larger delivery device for accommodating reservoirs filled with the increased dosage.

Abstract: There is described a medicament container assembly (1) comprising a medicament compartment (2); a first cover (3) including a preformed medicament outlet (4); and a second cover (5).

Abstract: A device and a procedure for the extemporaneous preparation of an individual quantity of sterile treatment fluid that may be compressible, in particular a treatment gas, the device comprising a rigid cartridge (3) with an outlet valve, an administration syringe (4) and a filtration-type connection/sterilization device (5, 6). The cartridge (3) simply contains an individual quantity of treatment fluid under pressure, and the cylinder of the syringe (4) is adapted to contain this individual quantity.

Abstract: The present invention provides pharmaceutical compositions comprising azelastine, or a pharmaceutically acceptable salt or ester thereof including azelastine hydrochloride, and optionally one or more additional active agents. Preferred such compositions further comprise one or more pharmaceutically acceptable carriers or excipients that reduce the amount of post-nasal drip, and/or that minimize or mask the unpleasant bitter taste associated with post-nasal drip, of the compositions into the oral cavity, upon intranasal or ocular administration of the compositions. Especially effective excipients used in the compositions of the present invention are hypromellose as a viscosity modifier and sucralose as a taste-masking agent.

Abstract: A filter for the removal of substances from blood product has a porous element of a polymeric material consisting of a polyether-ester copolymer or of a polymer blend comprising said copolymer.

Abstract: A collection device and a method for collecting a biological sample, particularly whole blood, includes a separating member to separate the whole blood into its components, and at least reagent positioned to selectively interact with a component of the separated sample. The reagent is able to selectively interact with the plasma/serum, and is prevented from contacting or interacting with the whole blood.

Abstract: A medical bag formed of a flexible material includes a front bag part and a rear bag part joined together to form a bag body. A closable liquid inlet port is provided in an upper part of the bag body. The medical bag further includes a deformable elongated member provided in the vicinity of the liquid inlet port on at least one of the front and rear bag parts. The elongated member is deformable so as to retain the liquid inlet port in an open configuration when the elongated member is in a deformed state.

Abstract: The invention refers to a medical system comprising a first subsystem with a first connection portion (7), and a second subsystem with a second connection portion (12). The invention also refers to a device and a method for connecting the subsystems to each other. One of the subsystems contains a fluid. The connecting device is adapted to connect the subsystems to each other to permit transport of the fluid from one of the subsystems to the other subsystem. The device comprises a container (21) enclosing an inner space. A substantially sterile atmosphere is provided in the inner space. The container receives the first connection portion and the second connection portion in the inner space. A mechanism is provided for connecting, from outside the container, the first connection portion and the second connection portion to each other in the inner space.

Abstract: Disclosed is a fluid transfer system for transferring a substance from one vessel to another vessel while avoiding leakage of liquid and gas contaminants. The transfer system includes a needle safe design that is facilitated by a housing that shrouds a tip of a fluid transfer cannula such that the cannula tip is not exposed for inadvertent puncture. This feature may also be enhanced by use of a blunt tipped cannula. The fluid transfer system permits multiple access by enabling the easy swabbing of a septum prior to use.

Abstract: A specimen container includes a specimen storing portion for storing a specimen, wherein the specimen storing portion is provided with an opening on an upper end, a sealing member for sealing the opening, wherein the sealing member is enabled to be passed through by a suction tube for sucking a specimen stored in the specimen storing portion, and a cylindrical portion having a predetermined height to allow insertion of the suction tube, wherein the cylindrical portion is arranged in series with the specimen storing portion on a side provided with the opening.

Abstract: A holder for receiving a sampling tube of a blood sampling system is disclosed. The holder has an interior pocket which can be conformed from a closed position to an open position for receiving the sampling tube.

Abstract: A transfer device for use in transferring a substance from a storage container into an ampoule that can be inserted into a device for dosed administration of substance, the transfer device including an adapter for securing the storage container and the ampoule relative to each other and coupling them to be able to transfer a substance contained in the storage container into the ampoule, and a displacement element that can act on the storage container such that the substance contained in the storage container is forced out of the storage container and transferred into the ampoule via the coupling formed by the adapter.

Abstract: A method and apparatus for obtaining various components of a multi-component material. Generally, a component of a whole blood sample may be concentrated from a patient and re-introduced to the same patient. For example, a clotting component, such as thrombin, from a whole blood sample may be extracted and concentrated in an apparatus and collection to be reapplied or reintroduced into a patient.

Abstract: A medical product is configured for use in a medical system. A method is provided for sterilizing the product. A connector connects a first subsystem and a second subsystem, containing a medical fluid, for transport of the medical fluid from the second subsystem to the first subsystem. The connector comprises a valve device, a first connection pipe connected to the first subsystem, and a second connection pipe connected to the second subsystem. The valve device comprises a first part and a second part movable relative to each other to permit an opening movement from a closed stable position, which prevents a fluid communication between the connection pipes, to an open position, which establishes a channel permitting the fluid communication. The connector comprises at least one small passage permitting, in the closed stable position, an introduction of a sterilizing gas to contact wall surfaces defining the channel.

Abstract: The present invention comprises packaged enemas for the treatment of Inflammatory Bowel Disease (IBD), having substantially pure 5-ASA as the active ingredient, with a liquid carrier medium having a material avoidance of bowel irritant substances, such as anti-oxidants for the 5-ASA active ingredient, including such sulfites as potassium metabisulfite, for example, and contained within a sealed and substantially oxygen-free barrier package, which may preferably be formed of a foil/polymer laminate, and which package contains or otherwise includes an oxygen scavenger, such as a an oxygen scavenging sachet.

Abstract: A pharmaceutical pig is used to transport a syringe containing a liquid radiopharmaceutical from a radiopharmacy to a medical facility for administration to a patient. The pharmaceutical pig includes an elongate polymer cap that is removably attached to an elongate polymer base. The elongate polymer cap includes a cap shell that completely encloses a cap shielding element and the elongate polymer base includes a base shell that completely encloses a base shielding element. Preferably the polymer utilized for the cap shell and the base shell is polycarbonate resin, e.g., LEXAN®. An inner liner is not utilized and the cap shielding element and the base shielding element, which are preferably, but not necessarily, made of lead, are completely sealed and unexposed.

Abstract: Described is a spring-loaded cartridge cap for use in a drug infusion pump. The cap is ejected if it is not properly inserted into the pump. In one embodiment, the cap includes three detent pins that mate with detents in a cartridge chamber within the drug infusion pump. As the cap is inserted into the cartridge chamber of the drug infusion pump, the distal end of the cartridge compresses a coil spring within the cap. To secure the cap within the cartridge chamber, the cap is rotated such that each detent pin moves within a slot until a locking detent is engaged.

Abstract: A method and apparatus for a connection interface between a reservoir or syringe, infusion set tubing, and an infusion pump is provided. A base is provided which is adapted to receive a reservoir. The base has a base engagement member, such as a detent, projecting therefrom. A cap is provided which is adapted to receive the base. The cap includes a first cap engagement member, such as a detent opening, which is adapted to removably engage the base detent. The cap further includes a second cap detent opening which is adapted to removably engage the base detent. A piercing member, such as a needle, is disposed in the interior of the cap in such a manner that the needle is separated from the reservoir septum when the base detent is in the first cap detent opening, and the needle pierces the reservoir septum when the base detent is in the second cap detent opening.

Abstract: The present invention relates to a cartridge or a cartridge holder adapted to be used in connection with handheld medication delivery devices. In particular, the present invention relates to intermediately positioned cartridges or cartridge holders providing at least one electrical connection between electronics of a medication delivery device and an injection needle attached to the medication delivery device. The electrical connection(s) between the electronics and the injection needle may be of galvanic or capacitive nature, the latter being provided via medicament contained in the cartridge.

Abstract: A connector system (10) for producing a sterile connection includes a fluid conduit (32), an engagement device (14, 22) designed to engage with a complementary engagement device (16, 24) of a complementary connector (12), a displacement device (26) with a substantially plane displacement surface (30) and a fluid conduit aperture (60) which extends through the displacement surface (30) and is connected to the fluid conduit (32), with the displacement device (26) being designed to displace the connector (12) and the complementary connector (12) relative to one another in a displacement direction (40) after the engagement device (14, 22) has engaged with the complementary engagement device (16, 24), and with the displacement direction (40) being substantially parallel to the displacement surface (30), and a sterile cover device (20, 74) designed to cover at least the fluid conduit aperture (60) in a sterile manner.

Abstract: A connector (10) is provided for sterile connection to a complementary connector (12). The connector (10) has a housing (14) with an engagement device (16) to engage a complementary engagement device (18) of the complementary connector (12) along an engagement direction (44). The connector (10) is displaceable relative to the complementary connector (12) along the engagement direction (44) after the engagement device (16) engages the complementary engagement device (18). The housing (14) has a feed-through opening (24) for receiving a sensor (34) and a cover (22). The cover (22) is displaced relative to the connector (10) along the engagement direction (44) to close the feed-through opening (24) in a sterile manner. The connector (10) also has a sterile sensor (34) that is movable along a sensor displacement direction (52) that differs from the engagement direction (44).

Abstract: The present invention provides antimicrobial solutions that comprise at least one alcohol, at least one antimicrobial agent and at least one chelator and/or anticoagulant. Also provided are methods for rapidly reducing a microbe or a virus from surfaces including surfaces of indwelling medical devices and organic surfaces such as skin and sutures, and inorganic surfaces such as hospital equipment, pipelines etc.

Abstract: The present invention refers to a non-collapsible and non-foldable container for lyophilization of a product, said container comprising: a) a plastic tray comprising a bottom wall, a continuous peripheral side wall defining an opening, and a continuous circumferential rim which is outwardly bulged; b) a top wall for completely covering said opening, which top wall is comprising a membrane which membrane is vapour-permeable and provides a bacterial barrier; c) a removable impermeable snap-on lid for completely covering said top wall and said membrane. The container of the present invention is used for lyophilization of products and is easy to handle and provides a suitable shape for heat transfer during the lyophilization process. Further, the inventive container provides means for easy handling of opening and closing the membrane area before starting the lyophilization process, and also provides means for easy and reliable sealing after the lyophilization process, thereby protecting the membrane.

Abstract: A medical fluid container of a flexible plastic material is produced as follows: at first, a plastic compound is produced from a heterogeneous mixture of a first, lower-viscosity raw polymer component having a first melt viscosity and a second, higher-viscosity raw polymer component having a second melt viscosity which is greater than the first melt viscosity. Then the plastic compound is extruded. The extrudate is confectioned. Finally, the confectioned extrudate is sealed to form the finished fluid container. A film tubing may serve as intermediate product for the medical container. The medical container or the film tubing thus produced has surface structures with a typical average size of 15 to 200 ?m. The production method requires little effort while fulfilling demanding requirements with respect to the stability of the produced fluid container.

Abstract: An apparatus for use in a fluid processing system having a pump. The apparatus includes a pump cassette for use with the pump. The pump cassette includes at least one pump chamber and a first port in selective fluid communication with the at least one pump chamber. A spiking assembly includes at least one hollow spike having a piercing end for piercing a first container. The at least one hollow spike includes a first spike in fluid communication with the first port of the pump cassette.

Abstract: A small multi-chamber container that has multiple individual sealed chambers is disclosed. Each chamber contains a substance to be extracted and applied with an applicator. The top surface of the container is slanted wherein one side of the chamber is higher than another side of the chamber. An applicator with an elongated hollow handle with approximately the same outside dimension as the inside dimension of the individual chambers is used to extract and apply the substance in the individual chambers. At one end of the applicator is an applicator tip generally in the form of a small spatula or spoon. When the applicator is inserted into one of the sealed chambers, the substance enclosed in the sealed chamber is forced out through the elongated hollow handle of the applicator into the applicator tip to be applied to desired surface.

Abstract: In certain embodiments, a vial adaptor for removing liquid contents from a vial comprises a piercing member and a bag. The bag can be contained within the piercing member such that the bag is introduced to the vial when the vial adaptor is coupled with the vial. In some embodiments, the bag expands within the vial as liquid is removed from the vial via the adaptor, thereby regulating pressure within the vial. In other embodiments, a vial comprises a bag for regulating pressure within the vial as liquid is removed therefrom. In some embodiments, a vial adaptor is coupled with the vial in order to remove the liquid. In some embodiments, as the liquid is removed from the vial via the adaptor, the bag expands within the vial, and in other embodiments, the bag contracts within the vial.

Abstract: A drug retention cap has a cap section and a drug retention pin. The cap section has a generally dome-shaped top end and a cylindrical portion extending downward from the generally dome-shaped top end. The top end of the cap section is closed, and the bottom end is open. The open bottom end is configured to receive a needle of a drug delivery device. The drug retention pin extends from near the apex of the dome-shaped top end downward toward the open bottom end. The drug retention pin is configured to fit inside a hollow needle.

Abstract: The invention refers to a new system for packaging pharmaceutical compositions comprising active principles that may be administered intravenously, in particular it concerns a system for packaging in bottles which makes it possible to ensure the complete transfer of the content of the bottle into the liquid for intravenous infusion and at the same time prevent any accidental contact with the active principle by the health-care personnel preparing said intravenous infusion, and a complete kit for intravenous administration.

Abstract: A method and device for transferring fluids from a non-sterile field to a sterile field within a surgical environment includes utilizing a device that includes a main body having a first inlet port that is in communication with a first outlet port. Fluid is taken from the patient, typically with a sterile syringe and transferred to the non-sterile field where the fluid is processed. The processed fluid is then drawn into another syringe in the non-sterile field and a distal end of the first syringe is place within the inlet port of the sterile main body. A distal end of a second sterile syringe is inserted into the outlet port, where the distal ends of the sterile syringe and the non-sterile syringe do not make contact. As a plunger is forced into a chamber of the first non-sterile syringe to force the fluid out of the first syringe, the plunger of the second sterile syringe is retracted such that a chamber in the second syringe has a sufficient volume to store the processed liquid.

Abstract: The present invention provides a one-piece bottle containing enteral feeding material and having a top end with a threaded section and a bottom end comprising a funneled connector port; and a threaded cap dimensioned to mate with the threaded section of the one-piece bottle; wherein the funneled connector port connects to an enteral feeding assembly; wherein the threaded cap provides a leak proof seal when tightened on the threaded section of the one-piece bottle, and allows venting of the bottle when loosened.

Abstract: A vial is closed by a stopper. The stopper is provided with arrangements allowing, in a first position, the filling of the vial with a liquid through an opening and, in a second position, the sealed and definitive closure of said opening.