Abstract: A specimen collection container having a separation chamber includes a first chamber, a second chamber, and a valve located between the first chamber and the second chamber. In an open position, the valve permits fluid communication between the first chamber and the second chamber. In a closed position, the valve maintains fluid isolation between the first chamber and the second chamber. A fluid stream passes from the first chamber to the second chamber through the valve permitting a predetermined volume of fluid to pass from the first chamber to the second chamber. When the predetermined volume of fluid passes to the second chamber, the valve transitions from the open position to the closed position so that additional fluid of the fluid stream received by the first chamber is maintained in the first chamber in fluid isolation from the predetermined volume of fluid contained in the second chamber.

Abstract: An apparatus for delivering or withdrawing a fluid through at least one layer of the skin is provided. The device may include a body having a top face, a bottom face, a side edge and at least one channel. The bottom face includes a first surface area and a second surface area adjacent to and recessed at a first distance from the first surface area. The bottom face further includes at least one raised protrusion disposed on the second surface area. The protrusion has a height from the first surface greater than the first distance. At least one dermal-access member is provided in the protrusion and is in fluid communication with the channel to deliver or withdraw the fluid.

Abstract: Antimicrobial lubricant compositions are disclosed. The antimicrobial lubricant compositions are particularly useful in providing antimicrobial capability to a wide-range of medical devices. The compositions include an oil lubricant. Representative lubricants may include polydimethyl siloxane, trifluoropropyl copolymer polysiloxane, and a copolymer of dimethylsiloxane and trifluoropropylmethylsiloxane. The compositions include rheology modifiers as necessary. The compositions also include antimicrobial agents, which may be selected from a wide array of agents. Representative antimicrobial agents include of aldehydes, anilides, biguanides, bis-phenols, quaternary ammonium compounds, cetyl pyridium chloride, cetrimide, alexidine, chlorhexidine diacetate, benzalkonium chloride, and o-phthalaldehyde.

Abstract: Embodiments disclosed herein relate to methods and systems for performing an automated assay, and particularly to performing an assay on a plurality of samples on an automated instrument.

Abstract: An I.V. flush syringe assembly includes a barrel having an inside surface defining a chamber for retaining fluid, an open proximal end and a distal end with a passageway therethrough in fluid communication with the chamber. An elongate plunger having a proximal end, a distal end and a stopper is slidably positioned in fluid-tight engagement with the inside surface of the barrel for drawing fluid into and out of the chamber by movement of the stopper relative to the barrel. The plunger includes anti-reflux structure for minimizing stopper deflection when fluid has been delivered from the chamber and the stopper is being forced against the distal end of the chamber.

Abstract: A system and method is provided for an injectable substance delivery device comprising a limiter, shoulder or post that controls how deep the needle is inserted into the tissue. The limiter is sized in proportions that control the maximum insertion depth of the needle into the tissue without excessively restricting the complete insertion of the needle. The system and method further comprises an normalization or stabilizer ring that prevents distortion of the tissue in the vicinity of the infusion, so that the needle length is the major determining factor as to how deep the infusion is delivered.

Abstract: The bioreactor is for use in performing biological and/or biochemical reactions and includes a vessel, an agitator, a reaction assembly, and a harvesting outlet. The vessel of the bioreactor includes several ports including a mixing port, a reaction port, and a harvesting port. The agitator extends through the mixing port into the vessel while the harvesting outlet extends through the harvesting port and permits the withdrawal of reaction medium to another vessel. The reaction assembly extends through the reaction port into the vessel and has multiple components including a gas conduit adapted to introduce gas into a reaction medium in the vessel, a sampling device adapted to remove a portion of the reaction medium from the vessel without contamination of the remaining reaction medium, and an introduction conduit permitting the introduction of at least the reaction medium into the vessel.

Abstract: A system and method for a patch-like, self-contained substance infusion device (700) which can be attached to a skin surface via an adhesive contact surface. A push button (780) activation assembly can then be used to remove an interlock (730), allowing a disk or Belleville spring (735) assembly to apply an essentially even and constant pressure to the contents of a fluid reservoir assembly (710). This allows the release of one or more spring-loaded patient needles (760) into the skin surface, and establishes a fluid communication path between the patient needles (760) and the pressurized fluid reservoir contents thereby delivering an infusion into the skin. The push button (780) activation assembly further allows the release of one or more improved safety mechanisms (794) after use.

Abstract: A process of manufacturing a sharps container and a method of storing needles are disclosed. The sharps container utilizes a blocking member which does not interfere with a needle being inserted into the sharps container, and a latch mechanism which does not require a protruding tab. The latch mechanism requires at least a dual action to open the sharps container, and limits the movement required for opening the sharps container.

Abstract: A medical article is provided including a chamber formed from a cyclic polyolefin having an inner surface in sliding engagement with an exterior surface of a sealing member, the inner surface of the chamber being coated with a composition including a first mixture of organopolysiloxanes having different molecular weights and a viscosity ranging from about 5,000 centistokes to about 100,000 centistokes; and a sealing member having an exterior surface coated with a second mixture of organopolysiloxanes having different molecular weights and having a viscosity ranging from about 10,000 centistokes to about 500,000 centistokes, the coatings being adhered to the surfaces by crosslinking induced by irradiation with an isotope, electron beam, or ultraviolet radiation.

Abstract: A low cost fluid collection set having an integrated package including a needle cannula having a first end and a second end, a hub configured for supporting the needle cannula, and a package at least partially enclosing the needle cannula and the hub is disclosed. The package includes at least one openable region configured for receiving a fluid collection device therein wherein this openable region is in communication with at least one of the first end or the second end of the needle cannula and wherein the package is configured to be used as a holding device to manipulate the needle cannula during fluid collection. The package also functions as a shield for the first end of the needle cannula after use. A method of using the fluid collection set having an integrated package and a method of making the fluid collection set is provided.

Abstract: A flow regulator for a blood collection assembly includes a housing having an inlet and an outlet, which defines an interior space between the inlet and the outlet. A membrane having a first surface and a second surface is disposed at least partially within the interior space. The membrane has a first position where a flow path between the inlet and the outlet is substantially open, and a second position where the flow path between the inlet and the outlet is at least partially restricted. The membrane is configured to move between the first and second positions in response to a pressure differential acting on the membrane.

Abstract: A label including a label body having an upper surface and a bottom surface and a light-transmissive portion and an opaque portion is disclosed. The label includes an adhesive disposed on at least a portion of the bottom surface for affixing the label body to a portion of a container. An excitation-activatable material arranged to contain machine readable information is disposed on at least a portion of the upper surface of the light-transmissive portion of the label body. The machine readable information is undetected by a detector in ambient light, and detectable by the detector upon application of an excitation wavelength to the excitation-activatable material.

Abstract: Compositions and methods for the rapid and sensitive detection of a carbapenemase in a sample are provided. The compositions include novel primer and probe compositions for use in detecting the presence of this enzyme in a sample, particularly using PCR methods. These primers and probe sets can be used in amplification methods (such as PCR, particularly quantitative PCR) and packaged into kits for use in amplification methods for the purpose of detecting carbapenemase in a test sample, particularly a patient sample, particularly a direct sample. Thus, in one embodiment, the present invention provides for novel oligonucleotide primers set forth in SEQ ID NOs:1, 2, 4, 5, 7, 8, 14, 15, 17, 18, and 20, and the novel oligonucleotide probe sequences set forth in SEQ ID NOs:3, 6, 9, 16, and 19. These sequences can be used in a method of detecting carbapenemase in a sample.

Abstract: A mechanical separator for separating a fluid sample into first and second phases is disclosed. The mechanical separator includes a float having a passageway extending between first and second ends thereof with a pierceable head enclosing the first end of the float, a ballast longitudinally moveable with respect to the float, and a bellows extending between a portion of the float and a portion of the ballast. The bellows is adapted for deformation upon longitudinal movement of the float and the ballast, with the bellows isolated from the pierceable head. The float has a first density and the ballast has a second density greater than the first density. The bellows is structured for sealing engagement with a cylindrical wall of a tube, and the pierceable head is structured for application of a puncture tip therethrough. The separation device is suitable for use with a standard medical collection tube.

Abstract: Sterile intravenous catheter securements and securement dressings that provide simpler, more effective, and lower risk intravenous catheter placement and securement in a patient are described. Catheter securement dressings may include one or more adhesive portions positioned and configured to maintain a position of a catheter assembly following catheterization. Catheter securement dressings may be secured to a patient with an adhesive portion, and the catheter assembly may then be placed into the patient through an access opening in the catheter securement dressing. Portions of catheter securement dressings may then by folded over and adhered to each other and portions of the catheter assembly to secure the catheter assembly to the patient.

Abstract: Intravenous catheter devices are provided which may include one or more adhesive portions which are positioned and configured to temporarily maintain a position of a catheter assembly following catheterization. A release liner covering and protecting the adhesive portions may be automatically removed to reveal the adhesive upon withdrawal of an introducer needle of the catheter assembly. The adhesive may be configured such that a clinician may insert the catheter assembly into the patient, adjust the catheter adapter of the catheter assembly to a desired position, withdraw the introducer needle, thereby removing a protective, non-adhesive release liner from the adhesive of the positioned catheter assembly, thereby temporarily fixing the position of the catheter assembly at the desired position by contacting the exposed adhesive to the skin of the patient.

Abstract: The present invention provides methods and separation media for separating analytes of interest via free flow electrophoresis (FFE) using volatile buffer systems. The separation media provided herein allow a convenient separation of the analytes by electrophoresis, and offer the additional advantage that the buffer compounds and the solvent can be easily and residue-free removed after the electrophoretic separation step. Furthermore, methods for mass spectrometric analysis of analytes comprising an FFE method and kits for carrying out FFE separations with volatile buffer systems are also provided. Preferably, the volatile buffer system is TRIS acetate.

Abstract: A plunger rod includes: an elongated body formed by a plurality of orthogonally spaced elongated ribs extending along a longitudinal axis; a first ledge adjacent a first end of the elongated body; a second ledge adjacent a second end of the elongated body; and an attachment portion extending from the second ledge. The second end of the elongated body opposes the first end of the elongated body. At least one elongated rib includes a retaining anchor positioned adjacent the second end adjacent the second ledge.

Abstract: A blood sampling device useful for collecting a blood sample from a separate vascular access device is described herein. The blood sampling device includes a body shaped and sized for partial insertion into a separate vascular access device. The body includes a reservoir defined within the body, which has an internal volume sufficient to contain enough blood for use in a diagnostic blood test. The body also includes a gas permeable vent disposed on the body, in which the gas permeable vent is in gaseous communication with the reservoir. When connected to a separate vascular access device the blood sampling device collects a blood sample as blood flows into the reservoir from the separate vascular access device and as gases pass out the reservoir via the gas permeable vent.