Abstract: Methods and systems for a cartridge assembly for use with an injection system are provided. An example cartridge assembly may include an ampule containing a pharmaceutical product that is sealed at a distal end with a pierceable diaphragm. The cartridge assembly may also include a hub comprising a proximal portion defining a cavity that is configured to engage the distal end of the ampule and a piercing member positioned within the cavity. The piercing member may include a fluid pathway between a proximal end portion comprising an opening and a distal end in fluid communication with a distal opening of the hub. The proximal end portion may engage the pierceable diaphragm, and the piercing member may apply a force to the pierceable diaphragm in the inactivated position without penetrating the pierceable diaphragm.

Abstract: Methods and systems for a cartridge assembly for use with an injection system are provided. An example cartridge assembly may include an ampule containing a pharmaceutical product that is sealed at a distal end with a pierceable diaphragm. The cartridge assembly may also include a hub comprising a proximal portion defining a cavity that is configured to engage the distal end of the ampule and a piercing member positioned within the cavity. The piercing member may include a fluid pathway between a proximal end portion comprising an opening and a distal end in fluid communication with a distal opening of the hub. The proximal end portion may engage the pierceable diaphragm, and the piercing member may apply a force to the pierceable diaphragm in the inactivated position without penetrating the pierceable diaphragm.

Abstract: Methods and systems for a cartridge assembly for use with an injection system are provided. An example cartridge assembly may include an ampule containing a pharmaceutical product that is sealed at a distal end with a pierceable diaphragm. The cartridge assembly may also include a hub comprising a proximal portion defining a cavity that is configured to engage the distal end of the ampule and a piercing member positioned within the cavity. The piercing member may include a fluid pathway between a proximal end portion comprising an opening and a distal end in fluid communication with a distal opening of the hub. The proximal end portion may engage the pierceable diaphragm, and the piercing member may apply a force to the pierceable diaphragm in the inactivated position without penetrating the pierceable diaphragm.

Abstract: A container closure system for delivering a fluid. The system includes a stopper constructed to seal fluidly a container. A closure member is mounted on an upper surface of the stopper. The closure member includes a base having an upper surface and a lower surface. The closure member further includes an outer wall and an inner wall extending from the upper surface of the base with the inner wall spaced from the outer wall. The base defines therethrough a needle access port between the inner and outer walls. The inner wall defines a chamber therein. The base further defines therethrough an aperture adjacent the chamber defined by the inner wall. A piercing member is movably disposed within the chamber defined by the inner wall. The piercing member has a first end portion and a second end portion, the first end portion being positioned proximally to the stopper. A piercing tip is mounted on the first end portion and is constructed to pierce the stopper.

Abstract: A cap assembly for a container has a hollow housing with an upper end that receives a fluid transfer device and a lower end that engages a stopper on the container. The housing has an internal cavity open at the upper and lower ends and a radially outwardly extending portion at the lower end. A penetrator is received in the internal cavity. The penetrator has a pointed distal end opposite the stopper and an upper end constructed to be engaged by a fluid transfer device. A cap is constructed the hollow housing. The cap has a closed upper end, an open lower end, a radially outwardly extending portion at the open end, and a circumferential line of weakness connecting the upper and lower ends. A ferrule is over the radially outwardly extending portion of the hollow housing and the radially outwardly extending portion of the cap.

Abstract: A penetrator for penetrating a stopper sealing an opening in a container. The penetrator includes a stamped piece of sheet material formed to define a shank having a length. A groove extends along the length of the shank. The shank has a pointed distal. The stamped piece of sheet material further includes a bearing plate extending from the shank at a proximal end opposite the distal end of the shank.

Abstract: A penetrator for penetrating a stopper sealing an opening in a container. The penetrator includes a stamped piece of sheet material formed to define a shank having a length. A groove extends along the length of the shank. The shank has a pointed distal. The stamped piece of sheet material further includes a bearing plate extending from the shank at a proximal end opposite the distal end of the shank.

Abstract: A penetrator for penetrating a stopper sealing an opening in a container. The penetrator includes a stamped piece of sheet material formed to define a shank having a length. A groove extends along the length of the shank. The shank has a pointed distal. The stamped piece of sheet material further includes a bearing plate extending from the shank at a proximal end opposite the distal end of the shank.

Abstract: A cap assembly is provided for mounting over the mouth of a container which is occluded with a stopper. The cap assembly includes a housing, a moveable piercing member or penetrator within the housing, a removable overcap over the housing, and a ferrule connecting the housing to the container. A preferred form of the penetrator is fabricated from sheet metal in a progressive die stamping process. One form of the overcap includes a frangible construction that permits the upper part of the overcap to be torn away to expose the upper portion of the housing.

Abstract: A closure is provided for mounting across the mouth of a container and through which liquid can be withdrawn with a fluid transfer device having a male member. The closure includes a body for being disposed on the container across the container mouth. The body defines a passage with an exterior opening for matingly receiving the male member of the fluid transfer device. A frangible seal initially extends across the passage in the body to occlude the passage. The seal is broken when it is engaged by the male member of the fluid transfer device, thereby establishing fluid communication between the fluid transfer device and the interior of the container.

Abstract: A penetrator for penetrating a stopper sealing an opening in a container. The penetrator includes a stamped piece of sheet material formed to define a shank having a length. A groove extends along the length of the shank. The shank has a pointed distal. The stamped piece of sheet material further includes a bearing plate extending from the shank at a proximal end opposite the distal end of the shank.

Abstract: A system is provided for accommodating the use of a syringe pump to inject a liquid agent into a patient from a vial having an internal chamber occluded at one end by a stopper located in the chamber to sealingly engage the vial and slide within the chamber. The system includes a plunger having a bearing end to be engaged by a movable pushing member of the syringe pump and having a drive end adapted to engage the stopper. A hollow piercing needle is mounted to the plunger to be connected in fluid communication with the patient and has a piercing end to penetrate the stopper. The needle moves with the plunger and stopper relative to the chamber as the liquid is discharged from the vial.

Abstract: A method of prefilling and terminally sterilizing a syringe including providing a syringe barrel having first and second opposite ends where the first end includes a port therethrough with a connector member formed about an exterior of the port and the second end being open. Particulate matter is removed from the interior of the syringe barrel and a cap and stopper are sterilized, the stopper including first and second opposite longitudinal ends. The first end of the stopper is inserted into the second open end of the syringe barrel until the first end of the stopper reaches the first end of the syringe barrel. The syringe barrel then is filled with a desired liquid, such as a medicament or imaging agent, through the port of the first end of the syringe barrel so that substantially no air enters the syringe barrel and where the stopper moves within the syringe barrel from the first to the second ends thereof upon filling.

Abstract: A drug reconstitution and administration system includes a container for a concentrated drug or other medicament, a syringe assembly which can be pre-filled with a liquid diluent, and a mixing adapter assembly which facilitates mixing of the medicament with the liquid diluent. The adapter assembly includes inner and outer concentrically arranged, relatively movable sleeves, which together define an expandable mixing chamber within the adapter assembly. The container and pre-filled syringe are respectively fitted to the adapter assembly, with the contents of the container and the contents of the syringe transferred into the internal mixing chamber. A diluted drug mixture is formed in the mixing chamber, and the mixture is transferred into the syringe assembly for subsequent patient administration.

Abstract: A needle guard assembly for a prefilled emergency syringe includes a cylindrical sidewall which extends coaxially with the syringe needle. The sidewall is joined to the syringe housing by spin welding or sonic welding an annular fusible portion that extends axially rearward from an annular flange on the base of the sidewall to contact the front wall of the housing. The sidewall is joined to the housing so that an annular clearance space for the hood is maintained between the hub and the sidewall guard.

Abstract: A luer adapter assembly for a prefilled emergency syringe includes a cylindrical sheath which extends coaxially with the syringe needle. The sheath can be integrally molded with the injector housing or is attached to the syringe injector housing by spin welding or sonic welding. The sheath is joined to the housing so that an annular clearance space for the removable luer adapter assembly is maintained between the tapered hub and the sheath. A removable cap on a threaded lock on the adapter extension is removed by twisting the cap in a first direction. The whole adapter assembly is removed from the tapered hub by twisting the cap in a second direction which is the same direction as the threads of the threaded lock.