Abstract: The present specification discloses collection kits for collecting a biological sample being handled by a chain-of-custody protocol and methods and uses for collecting a sample using such collection kits. In some aspects, a collection kit disclosed herein can comprise one or more identification labels, a sample collection device, one or more sample containers, and a collecting pouch. In some aspects, a collection kit disclosed herein can comprise one or more sample containers, a sample shipping container, one or more identification labels, and a collecting pouch.

Abstract: A plastic container has superior storage stability for pharmaceutical ingredients exhibiting a high affinity to plastic and can be mass-produced at low cost. The container has a bag body formed into a bag shape by a sheet member with a storage part on the inside thereof, and a tubular port member attached to the bag body, wherein one end of the tubular port member communicates with the storage part and an opening part of the other end is exposed outside of the bag body. The sheet member is formed from two or more layers including a base resin layer and an innermost layer formed from an amorphous polymer, as a main component, formed by polymerizing at least one type of olefin monomer, having a cyclic hydrocarbon skeleton, and the port member is formed from a resin having a crystalline polyolefin having no cyclic hydrocarbon skeleton, as a main component.

Abstract: The invention relates to a a single-use flexible bioreactor bag comprising a rigid multiport plate sealed to a side wall of said bioreactor bag, wherein said multiport plate comprises a plurality of ports. The invention further relates to a method of manufacturing the bag and to a method of installing the bag in a rigid support vessel.

Abstract: A thermal protection system configured for use with a dialysate container or bag in a dialysis system is disclosed. The thermal protection system being configured so that when the dialysate container is subjected to a temperature greater than a predetermined temperature such as, when the dialysate container is heated within a microwave oven, the thermal protection system is configured to (i) prevent the flow of dialysate from the bag, (ii) indicate that the dialysate container has been subjected to a temperature greater than the predetermined temperature, or (iii) a combination thereof. In one embodiment, the thermal protection system is a circular hollow ring positioned within an exit port of the bag, the ring melting upon reaching the predetermined temperature to block the flow of dialysate. Alternatively, and/or in addition, the thermal protection system may be a thermally sensitive dye configured to change color upon being subjected to the predetermined temperature.

Abstract: A packaged, sealed container system for stable storage of a formulation of an oxygen-sensitive pharmaceutical compound, the packaged, sealed container system comprising a primary container including therein a formulation of an oxygen-sensitive pharmaceutical compound, a secondary outer container comprising a first flexible sheet layer, an opposing second flexible sheet layer, and a seal disposed along a common peripheral edge of the first and second flexible sheet layers, such that the primary container is disposed between and enclosed by the first and second flexible sheet layers of the secondary outer container. An oxygen scavenger is also disposed between and enclosed by the first and second flexible sheet layers of the secondary outer container. The oxygen scavenger is in fluid communication with the contents of the primary container.

Abstract: The present invention relates to a bag containing preprepared injectable drug(s) and/or diluents for injectable drugs to be administered by intravenous (IV) application to a patient, said bag having an integrated flushing option.

Abstract: A reservoir and method for manufacturing a reservoir that includes a first side piece, a second side piece, an inner fold piece and a reservoir fitting. The first side piece may be sealed to the second side piece with a top seal and a first side seal and a second side seal. The inner fold piece may be sealed to the first side piece and the second side piece through a third side seal, a fourth side seal, and a bottom seal. The top seal may include a fitting opening and the reservoir fitting may be fit into the fitting opening. The reservoir may contain a volume sensing system. The reservoir may be designed so as to empty and fill reliably without any concern for neighboring organ impingement or compression.

Abstract: A testing method that includes the steps of evacuating air from a container to a negative atmospheric pressure, the container being a collapsible, flexible container, and comprising at least two opposing flexible walls, wherein a surface of at least one of the walls internal to the container comprises a plurality of channels or recessed features on said at least one wall and monitoring a mass flow or a state of vacuum so as to determine the integrity of the container. The container can be of any size or conformation, with or without attached fittings.

Abstract: The invention relates to a medical package designed as an infusion bag, which medical package is made from multi-layer films that are welded to one another and is filled with a medical liquid for infusion and/or for parenteral nutrition. The invention is described by a medical package designed as an infusion bag, which is made up of a film comprising multiple layers welded to one another and has at least one weld seam, preferably longitudinal and transverse weld seams, and is filled with a medical liquid. The multi-layer film has at least one inner layer of a matrix-phase polymer system, an intermediate layer of a matrix-phase polymer system, and an outer layer of a matrix-phase polymer system.

Abstract: A primary packaging for a liquid including an at least partially collapsible container and a connector element for connection of the primary packaging to a withdrawal device. The connector element has at least one connector channel which is in fluid communication with an interior space of the container. The container is composed at least partially of a foil which is constructed from a first layer which, during intended use of the primary packaging comes into direct contact with the liquid. Both the first layer and the connector element are composed of a plastics material including at least one cyclic olefin polymer.

Abstract: A system for blast-freezing items includes a plurality of cells arranged side-by-side, each cell including a housing with a bay space, a plenum, a front air passage, a rear air passage, and a fan. The fan is positioned in the plenum and configured to circulate air through the bay space. Each cell also includes a plurality of channels to separate pathways of air to segments of the bay space. The system also includes a plurality of crane rails extending between rows of cells and at least one crane capable of traveling along the plurality of crane rails to load or unload each of the plurality of cells.

Abstract: A repulpable zipper is provided for attachment to a repulpable flexible package. The repulpable zipper is formed using a water-soluble polymer combined with a repulpable material, such as a plant-based cellulose material. The repulpable zipper enables the repulpable package to be opened and closed by the consumer, so that the consumer has the option to determine, change or manipulate the contents of the repulpable flexible package.

Abstract: A method is described for reconstituting lyophilized mutant diphtheria toxin in dimethyl sulfoxide for use in producing pneumococcal capsular polysaccharide mutant diphtheria toxin conjugates.

Abstract: Systems, methods, and computer-readable media are disclosed for roll-formed containers for shipping. In one embodiment, an example container for an item may include a rectangular sheet of formable material, the rectangular sheet having a first crease line, a second crease line separated from the second crease line by a distance, a first crease pattern disposed adjacent to the first crease line, and a second crease pattern disposed adjacent to the second crease line. The container may include a sealant disposed about three sides of the rectangular sheet.

Abstract: A fluid collection apparatus for use in negative pressure wound therapy. The fluid collection apparatus includes a flexible bag having a first opening and a second opening. The bag includes a structure defining a fluid pathway connecting the first opening and the second opening. The pathway is circulative and contributes to orientation independence of the bag in use. The bag further includes a load-bearing component.

Abstract: A flexible pouch for packaging contents has a pair of leg portions having gussets. A bridge connect the leg portions. At least one arm extends upwardly. The pouch can be formed to represent various objects such as letters. The pouches can be formed with compartments for holding different components. The compartments may be separated by frangible seals to permit components to be mixed within the pouch.

Abstract: The invention relates to a protective housing for a biopharmaceutical liquid bag having a lower shell with a bottom and side walls, and an upper shell. The upper shell includes a housing for receiving the bag, and can be inserted into the lower shell, in such a way that the opening of the housing is adjacent to and facing the bottom of the lower shell, and in such a way that the upper shell is laterally held in place between the side walls of the lower shell.

Abstract: A photonic corpuscular irradiator machine, having an irradiation chamber having an external wall, a top edge, a bottom edge, an internal wall, and a spiral ridge; and an ultraviolet irradiation lamp. A machine assembly has an irradiation chamber housing, a bar code scanner, a control panel, an automatic peristaltic pump, and an intensity dial; and further having first and second blood bags. The external wall and the internal wall define a peripheral channel between them, and the spiral ridge extends within the peripheral channel. Blood from the first blood bag travels through an inlet port and is forced upwardly in a spiral motion along the spiral ridge within the peripheral channel and exits from an outlet port to the second bag. The irradiation bulb within of the cavity irradiates ultraviolet light to the blood within the peripheral channel. The ultraviolet light treats blood containing COVID-19 and/or pathogens.

Abstract: A method of manufacturing a composite sensor assembly includes: providing a port including a high surface tension thermoplastic, the port having a hollow tubular portion and a base having a polymer surface; fusing the polymer surface of the port to a wall of a polymeric bioprocess vessel so that the port communicates with an opening in the wall; and retaining a sensor unit within the hollow tubular portion of the port with an adhesive, at least a portion of the sensor unit being polymeric, wherein the port provides the sensor unit access to an interior of the polymeric bioprocess vessel.

Abstract: Method for the aseptic filling of a bag with a pharmaceutical product or liquid which comprises the following steps: a) a first step in which the cap is inserted in the inlet of the bag; b) a second step in which said cap is raised and the pharmaceutical product or liquid concerned is introduced; c) a third step in which the cap is re-inserted in the inlet of the bag; and d) a fourth step in which the cap and the inlet of the bag are welded.

Abstract: An intravenous fluid delivery apparatus (IFDA) includes a body having two or more docks, wherein each dock includes a dock outlet and is configured to engage with a container. The IFDA further includes a fluid interface having two or more interface inlets and an interface outlet, wherein the two or more interface inlets are in fluid communication with the interface outlet, and two or more supply lines, each supply line disposed between one of the dock outlets and one of the interface inlets, wherein the interface outlet is configured to connect with an intravenous line.

Abstract: A container for warming fluids comprises an inlet port, an outlet port, a fluid conduit configured for fluidly communicating the inlet and outlet ports, and deflection sections. The fluid conduit has a non-constant maximum width in a direction of fluid flow through the fluid conduit. The deflection sections further comprise an entry section and an exit section, each respective exit section being arranged downstream, in the direction of fluid flow, from each respective entry section. The maximum width of the fluid conduit decreases along the direction of fluid flow through the entry section over a first distance and the maximum width of the fluid conduit increases along the direction of fluid flow through the exit section over a second, different distance. An apparatus for warming fluids in, an extracorporeal blood circuit including, and a blood treatment apparatus including the container are also provided.

Abstract: A liquid transfer device includes a vial adapter that receives a vial. The vial adapter includes a vial spike that punctures a vial stopper of the vial and defines a vial spike lumen. The liquid transfer device also includes an intravenous (IV) port that receives a port spike of an infusion set. The liquid transfer device also includes a connector body including a vial adapter lumen in fluid communication with the vial spike lumen, a barrel connected to the IV port, and an IV spike including a central wall. The central wall defines a first IV spike lumen in fluid communication with the vial adapter lumen and a second IV spike lumen in fluid communication with the IV port. The first IV spike lumen and the second IV spike lumen are separated by the central wall.

Abstract: Provided is a loading tray assembly for housing a lyophilization container and a related system and method. The loading tray assembly includes a chassis including a contact void configured to facilitate direct contact between the attached lyophilization container and a lyophilizer shelf. The method includes securing a multi-part lyophilization container including a peelable seal on a lyophilization loading tray assembly, inputting a liquid into a non-breathable section of the lyophilization container, loading the tray assembly into a lyophilizer, freezing the liquid, applying heat energy and a vacuum, the vacuum causing an opening of the peelable seal and occluding the lyophilization container to isolate the frozen liquid.

Abstract: A method of dispensing a therapeutic fluid from a line includes providing an inlet line connectable to an upstream fluid source. The inlet line is in downstream fluid communication with a pumping chamber. The pumping chamber has a pump outlet. The method also includes actuating a force application assembly so as to restrict retrograde flow of fluid through the inlet while pressurizing the pumping chamber to urge flow through the pump outlet. A corresponding system employs the method.

Abstract: The pocket detection platform (PDP) detects pathogens, toxins and chemicals of interest simultaneously by way of a multi-channeled, soft see-through plastic pouch design that consists of inner and outer compartments that promote compartmentalization and/or unidirectional sample flow. The platform enables the concurrent running of multiple detection assay techniques such as lateral flow immunoassays (LFI), Isothermal molecular assays (i.e., Recombinase Polymerase Amplification, or RPA) and/or paper-based chemical assays (i.e., M8, pH paper) from a single wet or dry sample with minimal sample processing. The PDP reduces soldier overburden by decreasing size weight, and power (SWaP) as well as training time, electronic burden, while providing a flexible, customizable assay platform that can be rapidly produced, assembled, sustained, and when contaminated, easily to dispose of.

Abstract: An instrument 10 to prepare an intra-uterine device 30 for insertion in uterus 50 of woman, comprising a downfolding device 20, a graduated tube 16, a push rod 17, a stopper 15, and an IUD 30; the downfolding device 20 having a concave depression 41 on either side, an open channel 29 of a circular orifice 46 having a sector of angle measure 46A at least 220° and having an exit opening 48 initially marginally less than an external diameter 22B of the graduated tube 16, a root thickness 37B of the base 37 in-between the open channel 29 such that the exit opening 48 increases by the base 37 flexing; the graduated tube 16 has an internal diameter 22D of a far-end opening 22a of the graduated tube 16 sufficient to capture the stem 33 and both arms 32 of the IUD 30 in a downward triangular formation 51.

Abstract: A medical connector that allows ventilation of vapor used in vapor sterilization and has an internal flow route that is tightly closable without using any separate clamping device. A medical connector includes a body having an internal flow route connected to an other flow route, proximal portions included in the body and having respective one-side connection ports at which the internal flow route is connectable to the one flow route, a distal portion having an other-side connection port at which the internal flow route is connectable to the other flow route, one-side lid portion, and an other-side lid portion whose state is switchable between a closing state and a ventilating state in which the other-side lid portion covers the other-side connection port such that ventilation is allowed.

Abstract: The present invention refers to a system and method for opening a concentrate container without the need for a human to directly handle the concentrate container and connecting the concentrate container to a blood treatment device. Aspects of the invention are directed to a container for concentrate and a blood treatment device.

Abstract: The invention relates to a method and to a device for filling a medical packaging formed as a pouch. Preferably, the packaging is filled with liquid via a port, wherein the port is aerated with a protective gas, such as nitrogen, for example, during filling According to the invention, prior to filling with liquid, the packaging is filled with an inert gas, such as nitrogen, for example, which then provides the headspace of the filled and closed pouch. This results in a particularly low oxygen content in the headspace of the pouch.

Abstract: The invention relates to a welding tool and to a method for pulse welding of plastic films for medical packs formed as bags. In general, the invention provides that the film material which is plastified during welding and thus free-flowing is specifically displaced into a deepened, edge-side inner region of the sealing surface by increasing the sealing surface area. The film material accumulated in the recess leads to an increase in the film thickness in the inner region (25i) of the weld seam (6, 7, 8). As a result, the mechanical stability of the medical pack formed as a bag can be improved.

Abstract: An apparatus includes a blood-flow-management assembly shaped to define a cylindrical aperture. The blood-flow-management assembly includes a blood collector having drainage holes configured to direct blood to a guide surface positioned below the blood collector. The guide surface may further include ribs that manage blood flow along the guide surface.

Abstract: A collapsible liquid reservoir has a flexible side wall having a lower step, a middle step and an upper step. Each of the steps includes a riser segment and a tread segment. The riser and tread segments are pivotably connected to one another at an external hinge. When the step is collapsed its segments define an acute step angle between them of about 23°. When the step is expanded its segments define an obtuse step angle between them of about 115°. The tread of at least one step is pivotably connected to the riser of an adjacent step at an internal hinge. The step segments joined to the internal hinge are symmetrical about a bisector of that hinge. The reservoir has a truncated pyramid shape defined by a generally square base and four trapezoidal side panels joined to one another at corners.

Abstract: A multi-medicament infusion system (10) for preventing the mischanneling of medicaments may include an infusion pump (12), medicament reservoirs (16A,16B), a multi-channel lumen (18), and an infusion set (20). The medicament reservoirs may be sized and shaped differently such that the medicament reservoirs can only be inserted into the infusion pump in a unique configuration. The multi-channel lumen may include connectors that mate to corresponding connectors on the infusion pump and the infusion set only in a unique configuration. Because the various parts of the multi-infusion system may only be connected in the unique configuration, the expected medicaments may be administered appropriately and channeled to the correct infusion sites.

Abstract: An ejector device for ejecting droplets of fluid onto a surface includes an ejector mechanism attached to a fluid reservoir through a fluid loading plate that is configured to pierce the reservoir and channel the fluid to a rear surface of the ejector mechanism by capillary action. The ejector mechanism may have a centro-symmetric configuration with a lead free piezo actuator and may be covered by an auto-closing cover.

Abstract: A container for blood or a blood component is provided, the container comprising one or more container walls defining an interior chamber, the container walls comprising one or more layers, the layers comprising or consisting of a composition comprising one or more polymeric materials and at least one extractable agent selected from the group consisting of a terephthalate ester, a cyclohexane dicarboxylic acid ester, a citrate ester, and a polyol ester, wherein the container further comprises one or more additional components, wherein the container comprises less than about 3% (w/w) of di-2-ethylhexyl phthalate (DEHP), preferably wherein the container comprises less than about 3% (w/w) of phthalates. Thereby, improved blood products are provided in which the DEHP or overall phthalate content is reduced.

Abstract: A medical device system may include an elongate shaft having a lumen extending from a proximal end to a distal end, a release wire disposed within the lumen of the elongate shaft configured to releasably attach a medical device to the distal end of the elongate shaft, and a securement member fixedly attached to the proximal end of the elongate shaft and to a proximal end of the release wire. A proximal portion of the securement member may be configured to translate proximally away from the proximal end of the elongate shaft upon application of a proximally-directed force to the proximal portion of the securement member while the elongate shaft is maintained in a fixed position, wherein the proximal portion remains connected to the proximal end of the elongate shaft after proximal translation away from the proximal end of the elongate shaft.

Abstract: A medical device system may include an elongate shaft having a lumen extending from a proximal end of the elongate shaft to a distal end of the elongate shaft, a medical device disposed proximate the distal end of the elongate shaft, a release wire disposed within the lumen of the elongate shaft, wherein the release wire releasably secures the medical device to the distal end of the elongate shaft, a securement member fixedly attached to the proximal end of the elongate shaft and to a proximal end of the release wire, and a microcatheter configured to deliver the medical device to a treatment site, the elongate shaft and the medical device being slidably disposed within a lumen of the microcatheter. A proximal portion of the securement member may be configured to disengage from a distal portion of the securement member.

Abstract: An intravenous tubing set is provided having a coupling component for accessing a source of flush solution; a flush chamber; a first IV tubing for delivering saline solution from the source of flush solution to the flush chamber; a first flow control device disposed in the tubing between the source of flush solution and the flush chamber to control the flow of flush solution into the flush chamber; a second IV tubing for delivering flush solution to a patient catheter; and a second flow control device disposed in the second tubing between the flush chamber and the patient catheter.

Abstract: A container has an at least partially filled container body and at least one cap part (10). The cap part has at least one sealing part (16) that, for removal of the container contents, can be penetrated by a hollow-spike-shaped insertion part (22) from the outside, with a predeterminable actuating force, in an introduction direction. The insertion part can be removed from the container again, with a predeterminable pull-out force, in an oppositely directed pull-out direction. A device (16, 18) makes it difficult for the insertion part (22) to be removed with the pull-out force being increased such that unintentional removal of the insertion part (22) is at least made difficult.

Abstract: A tube for a medical container has a tube wall which consists of at least two layers. According to the invention, at least one layer contains a styrene-containing thermoplastic polymer (S-TPE), in particular a styrene-butadiene block copolymer (SBC) or a copolyester, a copolyester ether or a cyclic olefin copolyester. The at least one other layer contains ethylene-vinyl acetate copolymer (EVA), preferably with a vinyl acetate (VA) portion in the ethylene-vinyl acetate copolymer of from 10% to 30%, preferably 14% to 28%. The EVA can be mixed with a thermoplastic polybutene and/or SEBS to improve the tube properties. The tube wall can have a two-layer structure with an inner or an outer layer which contains the S-TPE, copolyester, copolyester ether or cyclic olefin copolyester, or a three-layer structure with an outer and inner layer containing the S-TPE or copolyester or copolyester ether.

Abstract: An assembly for adding a medication or like substance to a liquid solution in a flexible bag (10) is provided. The flexible bag (10) contains a liquid solution, such as dialysate. An adapter (14) extends from the flexible bag (10) and includes a skirt (20) having an array of resilient sections (22) for engaging and snapping onto a neck finish (106) of a separate vial (100) containing a medication or like substance. A locking device (16) is adapted to be secured about the skirt (20) in a locking position that prevents outward movement of the array of resilient sections (22) and thereby prevents disengagement of the vial (100) from the adapter (14). A method of transferring the liquid solution from the bag (10) to the vial (100), mixing the medication with the liquid solution, and returning the mixture to the bag (10) is also provided.

Abstract: A urinary catheter set includes a urine collection bag formed into an outer packaging for the urinary catheter set, and a urinary catheter positioned inside of the urine collection bag.

Abstract: An optical layered body including: a substrate layer formed of a resin containing a crystallizable polymer A; and a first surface layer formed of a resin containing an amorphous polymer B, wherein a glass transition temperature TgA of the crystallizable polymer A and a glass transition temperature TgB of the amorphous polymer B satisfy TgB>TgA, a crystallization temperature TcA of the crystallizable polymer A and the glass transition temperature TgB of the amorphous polymer B satisfy TcA?10° C.?TgB?TcA?60° C., the first surface layer has a plane orientation coefficient P that satisfies P?0.01, and a ratio of a thickness of the substrate layer relative to a total thickness of the optical layered body is 25% or more.

Abstract: Containers for the storage of red blood cell compositions are disclosed. The container walls are made of a plastic composition that includes a polymeric material and at least one extractable agent that includes a terephthalate ester in an amount effective to suppress hemolysis in red blood cells.

Abstract: An insert for use with a flexible liquid bag, having upper and lower ends, with the upper end of the bag having a hollow support structure with open upper and lower ends, mounted in an opening formed in the bag adjacent the upper end of the bag. The insert has open upper and lower ends with the lower end of the insert being received by the open upper end of the hollow support structure. A normally closed valve structure is positioned in the insert to prevent liquid from flowing therethrough. An actuator cap is threadably mounted on the upper end of the insert. The actuator cap includes structure to open the normally closed valve so that liquid in the bag may flow through the insert. The bag with the insert secured thereto will be inverted in use so that the liquid will flow downwardly from the bag.

Abstract: This invention concerns methods of packaging and shipping stem cells. Also disclosed are related package products.

Abstract: An intravenous tubing set is provided having a coupling component for accessing a source of flush solution; a flush chamber; a first IV tubing for delivering saline solution from the source of flush solution to the flush chamber; a first flow control device disposed in the tubing between the source of flush solution and the flush chamber to control the flow of flush solution into the flush chamber; a second IV tubing for delivering flush solution to a patient catheter; and a second flow control device disposed in the second tubing between the flush chamber and the patient catheter.

Abstract: A needle-free adaptor for removing liquid from a vial comprises a cannula adapted to piece a septum of a vial, a plurality of legs surrounding the cannula to secure the adaptor to the vial when the cannula has pieced the septum, an elastomeric membrane having a normally closed pinhole orifice, and a conforming surface having an orifice connected to the cannula. The elastomeric membrane has a stable convex shape and is adapted to receive a nozzle of a needle-free device. Pressed against the elastomeric membrane, the nozzle deflects the elastomeric membrane from the convex shape to an unstable or pseudo-stable inverted position against the conforming surface. Buckling of the elastomeric membrane opens the pinhole orifice and enables fluid communication between the vial and the nozzle by interfacing the pinhole orifice with the orifice on the conforming surface.

Abstract: A fluid infusion system includes an air pump connected to an accumulator tank to produce pressurized air that is stored in the accumulator tank. The system can include one or more fluid bag chambers wherein each fluid bag chamber includes an inflatable bladder positioned inside the fluid bag chamber to apply pressure on the fluid bag supported inside the chamber. The fluid bag can be connected by a tube set to deliver fluid from the fluid bag to a surgical tool at a surgical site. The fluid can, for example, be irrigation fluid or distention fluid. The system can include a controller connected to the pump to control the pump to produce the pressurized air and an adjustable pressure regulator can be connected between the accumulator tank and the inflatable bladder to control the pressure of air delivered to the inflatable bladder and the pressure that the fluid is delivered to the surgical tool.