MEDICAL NEEDLE-FREE INJECTION SYSTEM AND METHOD

    公开(公告)号:US20230414876A1

    公开(公告)日:2023-12-28

    申请号:US18244868

    申请日:2023-09-11

    CPC classification number: A61M5/2033 A61M5/31511 A61M5/31513

    Abstract: A spring-loadable fluid injection device for a needle-free syringe is provided and comprises a trigger positioned within the housing and actuated by depression of a push button or lever disposed opposite the dispensing end at an external actuation surface. The trigger has a trigger latch configured to release a trigger catch as heaving part of the spring-loaded piston of the device. The trigger catch is configured to urge the trigger latch in a direction transverse to the injection axis when the piston moves from the unloaded position to the loaded position. The compression spring is retained around the piston and retained within the housing by a piston head. The device further comprises a syringe adapter and a safety cap which prevents accidental triggering. An embodiment further includes a prefilled syringe adapter for aseptic filling of a needle-free syringe from a prefilled syringe.

    PREFILLED SYRINGE AND METHOD OF PREPARING A PREFILLED SYRINGE

    公开(公告)号:US20230310681A1

    公开(公告)日:2023-10-05

    申请号:US18330083

    申请日:2023-06-06

    Abstract: A method of preparing a prefilled syringe (1), comprises (i) obtaining a syringe barrel (11) having an open end (111) and a tip (112) with an orifice (113) essentially opposite to the open end (111), and a needle adaptor cap (12) assembled on the tip (112) of the syringe barrel, wherein the needle adaptor cap (12) has a rubber element (121) tightly sealing the orifice (113) of the tip (112) of the syringe barrel (11) and the syringe barrel (11) together with the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) is sterilized by a first sterilizing comprising a main step of exposing the syringe barrel (11) together with the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) to ethylene oxide for about 5 hours to about 60 hours at a relative humidity of about 40% to about 100% and at a temperature of about 30° C. to about 60° C.; (ii) filling a drug substance (14) through the open end (111) of the syringe barrel (11) into an interior of the syringe barrel; (iii) sealing the interior of the syringe barrel (11) by advancing a rubber stopper (13) through the open end (111) of the syringe barrel (11); (iv) packaging the syringe barrel (11) together with the rubber stopper (13) sealing the interior of the syringe barrel (11) and the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11); and (v) second external surface sterilizing the packaged syringe barrel (11) together with the rubber stopper (13) sealing the interior of the syringe barrel (11) and the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11). The rubber element (121) of the needle adaptor cap (12) and the rubber stopper (13) are made of a rubber material having a comparably low oxygen transmission rate such as, at 1 atmosphere, of not more than 64 cubic centimeter per square meter and day. The second external surface sterilizing comprises a main step of exposing the packaged syringe barrel (11) together with the rubber stopper (13) sealing the interior of the syringe barrel (11) and the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) to ethylene oxide for about 3 hours to about 30 hours at a relative humidity of about 40% to about 100% and at a temperature of about 25° C. to about 45° C. At least one of the duration, the relative humidity and the temperature of the second external surface sterilizing is essentially lower than the respective duration, relative humidity or temperature of the first sterilization.

Patent Agency Ranking