STERILE FLUID PATHWAY CONNECTION TO DRUG CONTAINERS FOR DRUG DELIVERY PUMPS

摘要

A user-initiated fluid pathway connection 300 includes: a connection hub 310, a piercing member 330, a sterile sleeve 320, and a drug container 50 having a cap 52, a pierceable seal 56, a barrel 58, and a plunger seal 60, wherein the piercing member 330 is initially retained within the sterile sleeve 320 between the connection hub 310 and the pierceable seal 56 of the drug container 50. The connection hub 3310 may include an internal aperture 3310D within the connection hub 3310 which functions as a flow restrictor and wherein a piercing member 3330 is connected to one end of the internal aperture 3310D and a fluid conduit 3030 is connected to another end of the internal aperture 3310D. A drug delivery pump 10 with integrated sterility maintenance features includes a housing 12, upon which an activation mechanism 14, an insertion mechanism 200, a fluid pathway connection 300 as described above, a power and control system 400, and a drive mechanism 100 connected to a drug container 50 are mounted. Methods of assembly and operation are also provided.