Abstract: Blood collecting devices for collecting blood from a patient using a single needle insertion are disclosed. Each blood collecting device typically includes a housing which is removably attached to a test tube or blood reservoir. A blood flow tube is disposed in fluid communication with the housing for distributing blood from a patient into the test tube or blood reservoir. The blood is distributed through a membrane cavity having a liquid-impervious and air-permeable membrane. At least one air opening is provided in the housing at the membrane cavity. Accordingly, air in the test tube or blood reservoir is displaced by the incoming blood through the membrane cavity and membrane and out the air opening or openings. Vacuum pressure in the test tube or blood reservoir is dispelled by the flow of air through the air opening or openings, membrane cavity and membrane and into the test tube or blood reservoir, respectively.

Abstract: A system for mixing or reconstituting a drug contained in a first container with a diluent or fluid contained in a second container. The second container has a port docking assembly for engaging the first container. The first container is rotatable and axially slidable within the port docking assembly. The port docking assembly has an actuator to urge a stopper fluidly sealing the first container into the interior of the first container. The port docking assembly further includes a movable plug constructed to fluidly seal the second container in a first, docked position and to provide access to the interior of the second container in a second, activated position, whereby fluid communication between the first and second containers is provided when the first and second containers are in the second, activated position.

Abstract: A system and method for autologous normovolemic hemodilution (ANH) are disclosed. The system can include a vacuum canister, which is sized to accept donor bags of a predetermined capacity. The vacuum canister is connected to a vacuum source which applies a suction to the donor bag within the canister. The system can include a canister having a self-generated vacuum, which includes compressible sidewalls that are spring-loaded to provide negative pressure needed to collect blood from a patient without the use of a gravity-induced siphon gradient. Also disclosed are ANH systems and kits that rely on a gravity-induced siphon gradient for blood collection.

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 pre-evacuatable or pre-evacuated container for medical purposes is provided. The container comprises a container body which is open at one side with a peripherally extending container wall and a bottom, and a cover element. The peripherally extending container wall of the container body has an end groove, into which a sealing element for sealing off the container body with respect to the cover element is or can be inserted.

Abstract: A system for removing or transferring a pharmaceutical product from a reservoir including an ampoule with a moveable piston therein and an adaptor which includes, generally along a longitudinal axis, a reservoir connector and an ampoule connector for coupling to the ampoule, wherein the ampoule connector includes at least one locking mechanism which, in a side wall, includes a resilient element generally corresponding to a portion of the side wall which extends along the periphery thereof and, at opposing ends, merges with the side wall.

Abstract: A medicant reconstitution system is provided which has a generally flexible fluid bag with associated administration and reconstitution ports. The reconstitution port is adapted for receiving a medicant container and the administration port is for administering a medical fluid to a patient. According to one aspect of the present invention, the administration and reconstitution ports are integrated in a relatively rigid port structure. According to another aspect of the present invention, the reconstitution port receives a piercing member which is rotatable to a selected position to establish fluid flow. According to yet another aspect of the present invention, one of the reconstitution port and the piercing member includes a cutting edge, while the other includes a frangible member. Contact between the cutting edge and the frangible member opens the frangible member to establish fluid flow.

Abstract: An airtight-packaged system including: (1) a combination of two independently prepared pharmaceutical drug forms composed of a first drug form in aqueous formulation containing amoxicillin trihydrate as active pharmaceutical ingredient and a second drug form prepared separately from the first and containing potassium clavulanate as active pharmaceutical ingredient, in which the active ingredients in the combination of the first and second drug forms are present in a nominal weight ratio of amoxicillin to clavulanic acid of from 20:1 to 1:1, and (2) a preparation containing at least one desiccant in amounts such that when the packaged system is stored under stress conditions at 40° C. and 75% relative humidity for up to 3 months, the dimerization of amoxicillin trihydrate does not exceed 1.5% by weight, and the degradation of clavulanic acid does not exceed 10% by weight.

Abstract: A liquid dispensing apparatus that enables liquid for drawing liquid from a bottle into an oral syringe without inverting the bottle includes a tubular cap member for insertion into the mouth of a bottle. The cap member defines upper and lower openings connected by a bore. The device includes an elongate tube having an upper end connected to the cap lower opening and a lower end positionable adjacent a bottom wall of a bottle. A plunger is positioned within the bore of the cap member and is movable between a retracted configuration that closes the tube upper end and an extended configuration positioned within the tube. The plunger also defines an aperture through which liquid from the tube may flow into the plunger when the plunger is at the extended configuration. Liquid may be drawn from the plunger when an oral syringe is inserted into the cap member.

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: A simple, disposable device for a wounded individual to dispense a antibiotic or other medicine directly into their own open wound or treatment of a wound by a second party. The device dispenses a preloaded quantity of dry medication from an opening that is covered by a removable cap. Removal of the cap followed by pressing of a plunger dispenses the medication. The design of the carpule, barrel, of the device, the preloaded powder medicament, the flexible rod and rod head that pushes the dry powder into the wound and material selection appropriate to use in unfavorable environments are other features of the device.

Abstract: Stable single bicarbonate-based solutions are provided. The bicarbonate-based single solution of the present invention includes at least calcium and bicarbonate and is stored or packaged in a sterile manner within a container with a gas barrier. The single solutions of the present invention can remain stable for three months or more. In this regard, the stable and single bicarbonate-based solutions of the present invention can be readily and effectively used during medical therapy, such as dialysis therapy.

Abstract: Various embodiments of the present invention are directed to transferring fluidic media from a vial to a reservoir. In various embodiments, fluidic media may be transferred from the vial to the reservoir by moving a housing portion to move a plunger head located in the reservoir to draw fluidic media from the vial to the reservoir. In other embodiments, fluidic media may be transferred from the vial to the reservoir while the reservoir is held by a holding unit and vibrated by a vibrator to remove air from the fluidic media. In some embodiments, fluidic media may be transferred from the vial to the reservoir by moving a handle operatively connected to a bias member for assisting with the transfer of fluidic media. In other embodiments, the transfer of fluidic media may be assisted by a bias member and a needle connecting atmosphere and the vial.

Abstract: A re-forming device in particular for mixing substances in the medical field, includes a hollow needle pointed at its two tips and fixed on a support defining two coaxial sleeves enclosing each end of the needle and designed to receive, one, the plug opening of a vial, the other, the hub of an injection tube of a flexible bag, so as to communicate, by perforating the plug and hub, the vial and the flexible bag via the needle. The sleeve, on the side of the flexible bag, is dimensioned and designed to be engaged on the hub in a first stable position wherein the device is secured to the bag without the needle being in contact with the hub and the sleeve is mounted sliding on the hub so as to pass, through simple depression of the device on the hub, from the first position into a second position, corresponding to the perforation of the hub by the needle.

Abstract: A system for removing or transferring a pharmaceutical product from a reservoir including an ampoule with a moveable piston therein and an adaptor which includes, generally along a longitudinal axis, a reservoir connector and an ampoule connector for coupling to the ampoule, wherein the ampoule connector includes at least one locking mechanism which, in a side wall, includes a resilient element generally corresponding to a portion of the side wall which extends along the periphery thereof and, at opposing ends, merges with the side wall.

Abstract: A hemoglobin solution packaged in a flexible oxygen-impermeable container system. The container system includes a multi-layer film having at least a product contact layer, an oxygen and moisture barrier layer and an exterior layer. The flexible container system further includes an interface port for filling the flexible container with the hemoglobin solution and delivering the hemoglobin solution. The hemoglobin solution comprises a substantially stroma and tetramer free, cross linked, pyridoxylated hemoglobin solution including preservatives such as ascorbic acid, glycine and dextrose.

Abstract: The present invention provides a connector device or reconstitution device (10) for placing a first container (12), such as a liquid container (e.g. flexible container or syringe), in fluid communication with a second container (14), such as a drug vial. The connector device (10) has a first sleeve (32) having a first end (36) and a second end (38). The first sleeve (32) has at the first end (36), a first attaching member (30) adapted to attach to the liquid container (12). The connector device (10) also has a second sleeve (34) having a first end (48) and a second end (50). A second attaching member (28) is attached on the second end (50) of the second sleeve (34) and is adapted to attach to the second container (14). The second attaching member (28) has a sealing member (84). A piercing member (76) projects within the sleeves (32,34) for providing a fluid flow path from the first container (12) to the second container (14).

Abstract: A vial for dispensing a liquid into a syringe is described which comprises a body section for holding the liquid, the body section having a top and a bottom; a port having a removable seal, where the port is adapted for a syringe connection and where the port is interconnected with the body section at a point near the top of the body section by a passageway which for at least a portion of its length extends above the level of the liquid in the body section when the vial is inverted, thereby preventing leakage of the liquid from the body section when the seal of the port is removed. A method of making the vial is also described.

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 bottle assembly includes a medicine bottle having a storage cavity and an outlet port, with the outlet port disposed on an exterior of the bottle and in fluid communication with the storage cavity. Liquid medicament is disposed in the storage cavity and defines a current fluid level. The outlet port is advantageously disposed entirely below the current fluid level and oriented generally upward. The outlet port is operative to selectively allow flow of the medicament out of the bottle. The assembly may further include a needless syringe having an angled tip. The exterior of the bottle may include a recess disposed above the outlet port, with the recess adapted to receive and retain the syringe. The recess is advantageously aligned with the outlet port. Other aspects and methods are also disclosed.

Abstract: A cup is provided for containing a liquid medicine. The cup includes a wall with a candy coated rim portion. The coating includes a mixture of sugar, water and agar, and a layer of flavored and/or colored powdered sugar. A plurality of inwardly extending spacer ribs are spaced around the wall of the cup. The spacer ribs preferably have a generally triangular shape. The cup is made by orienting the cup in an upside down position; dipping the cup into a heated liquid mixture of sugar, water and agar to coat the rim portion of the cup; removing the cup; allowing the liquid on the rim portion to partially cool to a tacky consistency; applying powdered sugar to the tacky liquid, and allowing the coating to completely cool. A tray is provided for holding a plurality of cups. The tray includes a bottom with a plurality of spaced, substantially upside down cup-shaped bosses projecting upwardly from the tray bottom. Each of the bosses includes a reinforced side wall. The tray has a reinforced peripheral wall.

Abstract: The method described herein reduces the amount of aggregating metal released into solutions of Interferon-?.

Abstract: The invention provides compositions and methods for cell separation. These reagents and techniques specifically agglutinate cells via surface antigen recognition and can be used to recover even rare cell types in high yield.

Abstract: The invention relates to an apparatus for dispensing fluid in a dosed manner, comprising a housing, a pressure bag and connecting means, the housing comprising a carrying device for suspending the pressure bag and pumping means for pumping pressure fluid into the pressure bag, a measuring device being provided for measuring, during use, the weight or changes therein of the pressure bag with a fluid container included therein, the connecting means being designed for connecting the pressure bag to the pumping means.

Abstract: A device for receiving a sample of liquid, such as a sample of bodily liquid which is to be subjected to further analysis, may include a body having at least a major surface and a minor surface. A sample-receiving chamber may be located in the body and may have an inlet end which opens into the major and minor surfaces of the body. A conduit may be located in the body, extending from the outlet end of the chamber, and may be arranged so as to allow the liquid to pass from the outlet end into the conduit by capillary action.

Abstract: A system for connecting a compatibility liner with a source of perishable therapeutic is provided. In one exemplary system for connecting a reservoir of perishable therapeutic with a lumen, a hollow hub having a first end and a second end is provided. The first end of the hollow hub, which contains a bond port, is in fluid communication with the second end. The second end of the hollow hub may contain a docking groove that is sized to couple a reservoir to it. The system also includes an inner hypo-tube having a proximal tip and an inner lumen. This inner lumen is lined with a therapeutic compatible lining and is in fluid communication with the second end of the hub through the proximal tip of the inner hypo-tube. The inner lining and the proximal tip in this system are configured to shield therapeutic ejected from the reservoir from contacting materials that can diminish the integrity of the therapeutic.

Abstract: The present invention relates to a sampling device for taking up a blood sample and for providing the blood sample for analysis of total cholesterol in said blood sample. The device comprises a receiving cavity for receiving, through capillary action, the blood sample to be analysed, said receiving cavity having a predetermined small volume; and an analysis cavity, arranged in communication with the receiving cavity, said analysis cavity having a predetermined optical path length. The receiving cavity contains a dried buffer, and the analysis cavity contains a dried reagent. The invention also relates to a method for quantitative determination of the total cholesterol concentration in a blood sample of serum/plasma by end point analysis.

Abstract: Apparatus is provided for use with at least one labeled radiopharmaceutical agent, the apparatus including a container (22) containing the at least one labeled radiopharmaceutical agent, and a portable computer-communicatable data carrier (120, 24) associated with the container (22), the data carrier (120, 24) containing imaging protocol information for use with the at least one labeled radiopharmaceutical agent. Other embodiments are also described.

Abstract: A suitable container for plasma lyophilization has been designed for lyophilization (lyo-bag), storage, reconstitution and administering of blood products. A rigid support frame for use with a lyo-bag with sidewalls was designed as an external removable supportive system was designed, which provides the necessary stability for the flexible container during lyophilization. A removable bottom wall support sheet was designed for use with any flexible container for lyophilization.

Abstract: A multi-layered plastic body for containing, storing or conducting a medical, diagnostic, pharmaceutical, cosmetic or other product, the plastic body including a first layer made of a stress fracture resistant plastic material, and at least a second layer adjacent to the first layer and made of a plastic material exhibiting a lower resistance to stress fractures than the first plastic material. The invention encompasses a suitable method of making the body.

Abstract: An apparatus 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: An enteral feeding device, includes a system for delivering liquid nutrients to an enteral feeding tube. The device includes: (a) a container, having first, second and third openings; (b) a tip configured to be coupled to the container, the tip having an opening in fluid communication with the first opening of the container, the second opening of the container configured such that nutrient can be delivered to the second opening and the third opening configured to receive nutrient or to allow gas expelled from the patient (e.g., through burping) to flow there through.

Abstract: A flexible container incorporating flexible front and rear sheets and one or more container ports disposed in between the sheets are discussed. The one or more container ports each has a pliable attachment flange and an integrally molded nozzle. The pliable attachment flange has a first configuration whereby the attachment flange collapses to enable heat sealing the attachment flange to the sheets and thereafter substantially recovers its shape to provide a fluid pathway with the port. Various terminal ports. terminal caps. and rubber septums may be useable with the one or more container ports.

Abstract: A method and apparatus for technique and cycling (Techni-cycling as herein defined) such that converting delivery supply containers (supplies) into waste and disposal receptacles is disclosed. More particularly, a container transformation comprising deriving a supply container from a health care delivery sequence and converting the container into a waste receptacle by connection to a vacuum/suction source and collection system reduces the amount of waste contributed to the waste stream.

Abstract: A protective package for a medicament dispenser has an inner protective layer and an outer chemical barrier layer. The protective package also includes at least one reinforcing layer secured to the outer chemical barrier layer. At least one light inhibiting layer is further provided to limit the transmission of light through the package.

Abstract: A fluid ducting assembly for enabling flow communication between a syringe and either one of a vessel and a dispenser for dispensing a fluid contained, a priori in the syringe or in the vessel. The fluid ducting assembly includes a base having a first member, a second member, and a third member for connection to and providing flow communication with the syringe, the vessel and the dispenser, respectively. The fluid ducting assembly further includes a flow controller within the base enabling any one of a flow path between the first member and the second member and a flow path between the first member and the third member. The flow controller has either a first operative position in which the flow path between the first member and the second member is enabled or a second operative position in which the flow path between the first member and the third member is enabled.

Abstract: A bag system for the collection and sampling of a biological fluid such as blood is described. The system may include a fluid collection bag and a first tube connected on one end to a collection means and on the other end to the collecting bag. It may also include a flexible sampling bag defining an internal volume having a bottom side and an introduction side which is opposite to the bottom and has an inlet orifice. The system also has a second tube, a first end part of which is connected to the first tube and a second end part of which is inserted in the inlet orifice of the sampling bag, so as to extend inside the sampling bag over a distance of between 25% and 60% of the distance between the bottom and the introduction side of the internal volume of the sampling bag.

Abstract: Systems and methods manually process blood and blood components in sterile, closed environments, which further condition the blood components for subsequent pathogen inactivation processes. The systems and methods mate the manual collection of random donor platelet units with the creation of larger therapeutic doses of platelets targeted to undergo pathogen inactivation prior to long term storage and/or transfusion.

Abstract: The invention concerns an ampule comprising a tubular body (2) made of synthetic material having two chambers (3, 4) tightly isolated by a membrane (9) capable of being perforated or a removable or frangible wall, one (31) of which contains the liquid or the powder (6), and the other is accessible from outside to be connected during transfer, the frangible membrane (9) or wall being arranged at the end of a tube (8) integral with the ampule and emerging into the chamber (4) capable of communication with outside, said tube (8) containing a tubular element (14) having a pointed tip (17) oriented towards the membrane. The tubular element (14) and the tube (8) comprise means (13, 16) preventing the tubular element (14) from being separated from the tube (8) after one has been mounted into the other.

Abstract: A connector for forming a sterile connection between two tubes, comprising first and second parts which comprise connectable conduits and which can mate, first and second covers which can be removed from the so-mated parts to expose connectable ends of the first and second conduits, so that the conduits can then be connected.

Abstract: An eyewash system is disclosed. The eyewash system includes a mounting apparatus and a container coupled to the mounting apparatus and having a removable portion. Movement of the container relative to the mounting apparatus separates the removable portion from the container to provide an opening in the container. The removable portion may be provided on a cap coupled to the container. The container may be coupled to the mounting apparatus by a retaining device (such as a pin) inserted through one or more members extending from the base and through a tab extending from the removable portion.

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: The zone of weakening, which is designed as a slot (6a), is bordered by film material (7) on both sides according to length, i.e., across the direction of loading, which is indicated by the arrows F. Tearing (8) which progresses from the edge because of microscopic damage comes to a standstill at the slot (6a) at the latest, because stress peaks are dissipated here and the locally increased stresses are diverted into elements of the film material (7) which are under less stress. Other embodiments include a locally interrupted adhesive layer for separation of an upper film layer from a lower film layer, these two film layers being otherwise glued together. The adhesive-free recesses here constitute zones of weakening in the sense of the present invention. This therefore prevents tears from spreading from one film layer to the next. Furthermore, the propagation of tearing is counteracted due to the dissipation of stresses when a tear that forms in the film layer reaches the zone of weakening.

Abstract: An apparatus and method for collecting whole blood and then separating it into components for subsequent use or storage. A self-contained bag set is used to collect the sample, which may then be placed into a device adapted to fit into a centrifuge for separation of components. Each component is then sequentially extracted according to density, with a sensor present in the device to control the operation of valves directing the collection of each component. Each component may then be separated into its own storage container.

Abstract: A hemoglobin solution packaged in a flexible oxygen-impermeable container system. The container system includes a multi-layer film having at least a product contact layer, an oxygen and moisture barrier layer and an exterior layer. The flexible container system further includes an interface port for filling the flexible container with the hemoglobin solution and delivering the hemoglobin solution. The hemoglobin solution comprises a substantially stroma and tetramer free, cross linked, pyridoxylated hemoglobin solution including preservatives such as ascorbic acid, glycine and dextrose.

Abstract: An apparatus that allows for separating and collecting a concentrated fraction of a fluid, such as a whole blood sample, adipose tissue, or a bone marrow 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. The apparatus includes a container to be placed to a centrifuge after being filled with a whole blood sample. A buoy or fraction separator, which has a density less than that of red blood cells of a whole blood sample, is disposed in the container. During the centrifuge process the buoy separates the red blood cells from another fraction of the whole blood. After the centrifuge process is finished a plunger is used to produce at least two other fractions, including a plasma fraction and a buffy coat. Then, the buffy coat may be removed from the container without commingling the fractions of the sample.

Abstract: An improved solution for use in the removal of cataractous lenses via liquefracture is described. The liquefracture solution contains a viscosity-enhancing agent to increase the residence time of the solution in the heating chamber of the liquefracture handpiece, thereby increasing the expulsion force of the solution from the handpiece (i.e., “pulse force”). An agent that releases gas when the liquefracture solution is heated in the handpiece may also be included in the solution, thereby also enhancing the pulse force of the solution upon expulsion from the handpiece. The solution preferably also contains a partially water-soluble agent that forms a temporarily insoluble precipitate when heated in a liquefracture handpiece. The precipitate acts as an abrasive agent when expelled with the liquefracture solution from the handpiece, thereby facilitating the cutting and disintegration of the cataractous lens material.

Abstract: A blood donation device with a receptacle for a blood donation container and a control section at which utensils required by the operator can be accommodated and/or by means of which parameters of the donation process can be varied, detected and/or retrieved. Bending of the operator to the blood donation device is avoided by the fact that the control section is arranged in an elevated position with respect to the receptacle of the blood donation device.

Abstract: A device for drawing fluid from a lumen, and particularly blood from a blood vessel, is disclosed. The device may provide indication of the entry of an intravenous cannula into the lumen. The device may include a central body having an outer wall and an inner fluid passage. The device may include a luer-type adapter to permit the attachment of an I.V. infusion set of various lengths (“butterfly needle”) and or any luer-type fitting attached to an existing device. The outer wall of the central body may be transparent or translucent to permit the detection of fluid within the inner fluid passage. A front cannula may extend from one end of the central body and a rear cannula may extend from the other end of the central body. Both the front and rear cannulae may communicate with the inner fluid passage. A flexible sleeve may surround at least a tip portion of the rear cannula. A venting member may be provided near a base portion of the rear cannula between the flexible sleeve and the ambient.

Abstract: A packaging bag for a liquid biological substance such as animal semen, including two walls made of plastic material joined in such a manner as to delimit a pouch for receiving the substance and, communicating with the pouch, an evacuation conduit whose end part, in the absence of opening of the bag, is closed by the joined walls, wherein, force-fitted in the conduit, a cannula being able to communicate with the pouch is provided, while a second end of the cannula is situated in the proximity of the end part of the conduit having a conical or substantially conical constriction, and wherein conduit communicates, over a part of its length, with at least one zone situated not far from the end part, in which the two walls are not joined.