Needle assembly for a prefilled syringe system

摘要

A needle assembly (10; 210) for a prefilled injection syringe is described. A needle holder (12; 212) has a needle (14; 214) secured to it and is adapted to be secured to a syringe barrel of the injection syringe. A needle sheath (16; 216) has a distal end forming a releasable sterile seal with the needle holder (12; 212), and surrounds and shields the needle (14; 214). A needle seal (18; 218) surmounts the needle tip and is arranged at least in part in the proximal end of the needle sheath (16; 216) and closed off by a closure element (20; 220). A closure connection between the closure element (20; 220) and the needle sheath (16; 216) is configured as a non-releasable and sterile barrier (54; 254) produced by means of bonding or welding.

主权项

1. A needle assembly (10; 210) for a prefilled injection syringe, comprising:
a needle holder (12; 212) adapted to be secured to a syringe barrel of the injection syringe and a needle (14; 214) secured to the needle holder (12; 212); a needle sheath (16; 216) having a distal end and a proximal end, releasably connected at its distal end to the needle holder (12; 212) to form a sterile seal, and surrounding and shielding the needle (14; 214); a needle seal having a distal end and a proximal end (18; 218), located on the needle tip and arranged at least in part in the proximal end of the needle sheath (16; 216), said needle sheath (16; 216) being a tubular member (32;232); and a closure element (20; 220) that closes off the proximal end of the needle seal, said closure element (20;220) being a cap (56; 256) with a cylindrical shell (60;260) having a distal rim (62; 262); a closure connection between the closure element (20; 220) and the needle sheath (16; 216), configured as a permanently non-releasable and sterile barrier (54; 254) produced by means of bonding or welding; wherein the proximal end of the needle sheath (16; 216) is provided with a ring flange (34; 234) and the distal rim (62; 262) of said cap shell (60; 260) connects to said ring flange (34; 234) of said needle sheath (16; 216) to form the permanently non-releasable and sterile barrier (54; 254) produced by means of bonding or welding.