Abstract: A safety needle assembly has a needle hub and a needle cannula projecting from the hub. Wings project transversely from the hub to facilitate manipulation and positioning of the needle assembly. A shield is hingedly attached to the needle hub and can be rotated from a first position where the needle cannula is exposed to a second position where the needle cannula is shielded. At least one latch may be disposed on the shield for secure locked engagement with the hub, the wings and/or the tubing extending from the hub. A spring may also be provided for propelling the shield into the second position.

Abstract: A needle assembly includes a transparent or translucent housing with a fluid inlet end, a fluid outlet end, a flashback chamber and a venting mechanism therebetween. Substantially axially aligned inlet and outlet cannulas extend from the housing and communicate with the chamber. A sealable sleeve covers the external end of the outlet cannula. Relative volumes of the cannulas, the chamber and the sleeve are selected to provide rapid reliable flashback indicative of venous entry with an internal vent plug over the outlet of the flashback chamber to inhibit leakage of blood from the needle on withdrawal from the patient.

Abstract: A system, method and computer readable medium of instructions are provided which are useful for determining whether an evaluation testing method or device is clinically equivalent to a reference testing method or device. The report can include a modified mean difference plot, a variability chart, confidence intervals for bias and a plot of the intervals. A graphical user interface is provided to allow data associated with the reference and evaluation methods or devices to be identified. A level of variance in the reference method is determined. An observed bias between the evaluation methods or devices and the reference methods or devices is calculated. A confidence interval for the bias is calculated. The biases between the evaluation methods or devices and reference method or device is compared relative to the level of variance in the reference method, and a report is generated including a conclusion about whether the evaluation methods or devices are clinically equivalent to the reference method or device.

Abstract: A shieldable needle device including a needle cannula, a hub, a pair of wings extending laterally from opposing sides of the hub, a tip guard axially movable along the needle cannula from a proximal position substantially adjacent the hub to a distal position, and a drive member is disclosed. The drive member includes a first end connected to the hub and a second end connected to the tip guard and is extendable between a folded biased position and an extended position for moving the tip guard from the proximal position to the distal position. The pair of wings, when in a dorsal position, retain the drive member in the folded biased position maintaining the tip guard in a proximal position. Upon release of the wings, the drive member unfolds, extending the tip guard from the proximal position toward the distal position.

Abstract: A fluid collection or infusion set is provided. The set includes flexible tubing with a fitting attached to a proximal end and a needle assembly attached to the distal end. The needle assembly includes a needle hub and a needle cannula secured in the hub. An actuator arm extends proximally and outwardly from the needle hub and has an actuator button at its free end. The needle assembly is disposed in a barrel and can move from a distal position where the needle cannula is exposed to a proximal position where the needle cannula is shielded. A spring is disposed in the barrel for propelling the needle assembly to the proximal position. The barrel includes an actuating aperture that receives the actuator button for locking the spring in a compressed condition. Depression of the actuator button enables the spring to propel the needle assembly into its proximal shielded position.

Abstract: A method for surface marking a solid substrate (1), according to which, during an exposure sequence, said substrate is exposed to coherent monochromatic light (2) in order to strip said substrate over an indented surface (3), wherein the exposure conditions, including duration, are set in order to restrict said indented surface to simple abrasion designed for the bonding of a printing medium, and the exposure sequence is followed by a sequence of projecting in discrete form, during which particles (6) of said printing medium, the deposition of which subsequently defines a printed element (4), are projected in targeted fashion into the indented surface (3, 31).

Abstract: The invention concerns a plastic package, having a content capable of being sterilised at high temperature, said package comprising at least a fluid communication member (16) between the inside and the outside of said package consisting of at least a frame circumscribing an opening and an inner seal (18) closing the opening, and whereof the peripheral edge (18a, 22a) continuously linked to said frame, said inner seal including, a selectively sealing material sheet whereof the cutoff threshold from outside inwards, stops contaminating particles and allows through the thermal sterilising fluid, said selectively sealing material being deformable in the plane of said sheet at said high temperature.

Abstract: A medical device including a syringe assembly and a shield system for delivering medicament to a patient. The syringe assembly includes a barrel defining a medicament reservoir, a needle cannula coupled to the barrel and in fluid communication with the reservoir, a plunger having a stopper positioned in the reservoir and a thumb pad for moving the plunger in the reservoir. The shield system has a first shield coupled to a forward end of the barrel, and a second shield movable from a first position disposed from the needle cannula tip to a second position covering the needle cannula tip. An urging member controlled by a retaining device urges the second shield to the second position upon movement of the stopper to a position which releases the retaining device.

Abstract: A drug delivery system for administering preset doses of a substance such as a drug, vaccine or the like. The drug delivery system includes a holder and a pre-filled drug container such as a syringe which is retained in the holder. The drug container includes a barrel for containing the substance, a movable stopper situated within the barrel, and a blunt end having an opening through which the substance within the barrel can be expelled. The holder includes a distal portion and a proximal portion, each configured to accommodate the drug container, with the distal portion being able to be assembled to the proximal portion, which acts as a plunger rod during activation of the delivery system. A plurality of slots are provided on the holder that permit multiple equal doses of the substance to be administered to each nostril of the patient.

Abstract: A passive shield system for a syringe including a body, shield, spring and ring which provide an interlock of the shield in the retracted position prior to receipt of the syringe for bulk transportation and processing and wherein the user selects the timing of the release of the shield to its extended position following injection, but which assures shielding of the syringe needle following release of the syringe plunger.

Abstract: A spray device including a barrel having a bypass and at least two spaced stoppers defining a first and second chambers and a spray nozzle. Movement of the first stopper drives the second stopper to the bypass and the fluid in the first chamber into the second chamber, mixing the fluid and substance. Continued movement of the first and second stoppers drives the mixture through the spray nozzle. The spray device may include a third stopper having a body in the tubular barrel which is moved toward the spray nozzle. The movement of the third stopper provides space for the mixture and prevents unpressurized fluid from flowing through the spray nozzle. The third stopper includes an axial stalk. The stalk may be deformable or the stalk may be separate from the body and the spray nozzle includes a longitudinal internal passage which provides communication with the spray port.

Abstract: Luer lock type connection device for medical use having a nozzle in which an axial internal passage is formed. The nozzle includes a bearing connection surface and a proximal annular retention zone. The connection device also has a flange forming an axial open seat having a wall that includes a distal part with internal screw thread, and a transverse proximal part in which a central proximal retention opening is formed, and whose diameter is matched to that of the proximal annular zone of the nozzle. The proximal annular retention zone of the nozzle and/or the central proximal retention opening of the flange include a circular band or cord covered or treated with a roughening agent.

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

Abstract: A medication delivery pen is provided including a leadscrew having a plurality of threads; a driver coaxially disposed about at least a portion of the leadscrew; a dosing ring non-rotatably disposed on the driver, the dosing ring also being slidable along the driver; and, a dose knob coaxially disposed about the dosing ring. At least one tooth is formed on one of the dose knob and the dosing ring, and at least one groove is formed on the other of the dose knob and the dosing ring, with the groove being formed to receive the tooth. The dosing ring is selectively movable relative to the dose knob from a first position where the tooth and the groove are spaced apart to a second position where the tooth is received within the groove, the dosing ring being rotatable with the dose knob with the dosing ring being in the second position.

Abstract: A method of sealing a cartridge having a barrel with a polymeric closure, wherein the polymeric closure includes a tubular collar portion and an integral radial portion, The method includes disposing the tubular collar portion over the radial rim portion of the barrel to surround the reduced diameter neck portion and incrementally rolling and radially deforming the tubular collar portion adjacent its free end into the reduced diameter neck portion with a crimping tool, wherein the polymeric closure is sufficiently malleable to permit radial deformation, yet sufficiently rigid and resistant to creep to retain its shape following deformation The crimping tool or tools include an inclined surface having a gradually decreasing angles of inclination which are driven against the tubular collar portion adjacent the free end and the cartridge assembly and crimping tool are relatively rotated.

Abstract: An intradermal needle assembly that is attachable to a prefillable container intended for intradermally injecting substances into an animal includes a needle cannula supported by a hub portion. The hub portion is adapted to receive the prefillable container just prior to administering the intradermal injection. A limiter portion surrounds the needle cannula and extends away from the hub portion toward a forward tip of the needle cannula, and includes a skin engaging surface with the needle cannula having a fixed angle of orientation, preferably generally perpendicular, relative to the plane of the skin engaging surface. The skin engaging surface is received against the skin of an animal to administer an intradermal injection. The forward tip extends beyond the skin engaging surface a distance enabling penetration of the needle cannula into the dermis layer of the skin of the animal enabling injection of the substance into the dermis layer.

Abstract: This connecting device applies to a sealed connection device in which, firstly, each chamber, respectively a stationary chamber “A” and a transportable chamber “B” has at least one access opening equipped with a door (2, 3) cooperating with a flange (4, 5) with the interposition of sealing elements (12, 14), one (2) of the two doors being articulated to its flange (4), and secondly, the two doors (2, 3) have an element to lock their respective flanges (4, 5) and complementary connecting elements which allow them to be connected thereby forming, through contact of sealing elements (12, 16), an internal space “C” isolating their faces (17, 18) opposite each other from the external medium.

Abstract: A pen-style injector (20) includes an automated mover (70) that completes a combination of two substances such as a reconstitution process to reconstitute a lyophilized medicament prior to making an injection. The automated mover (70) is preloaded selectively released to automatically reconstitute the medicament at a controlled rate. The illustrated embodiment includes a mechanical spring (70) that provides the necessary movement of components within the injector (20) to complete the automated reconstitution process. The injector also has safety features (100) to prevent an injection prior to completing the automated combination of the substances.