Aseptic cartridge and dispenser arrangement

Abstract

A cartridge for use with a beneficial agent delivery device having a tillable reservoir. The cartridge includes a reconstitution, unit dose package having first and second compartments and a fitment. The first compartment contains at least a first constituent of the beneficial agent. The second compartment contains at least a second constituent of the beneficial agent. The fitment is disposed on the package for interfacing the package to the tillable reservoir.

1 .- 255 . (canceled) 
     
     
         256 . A cartridge for use with an injector, comprising:
 a first wall that comprises at least a first cavity;   a second wall in sealing engagement with the first wall to define at least a first sealed compartment at least partially defined by the first cavity, wherein the first sealed compartment is adapted to contain a first deliverable substance; and   a fitment to selectively provide fluid communication between the first sealed compartment and a reservoir of the injector via a passageway of the fitment to transfer the first deliverable substance from the first sealed compartment to the reservoir of the injector, wherein the fitment defines at least a portion of an aseptic zone through which the first deliverable substance is transferred between the cartridge and the reservoir.   
     
     
         257 . The cartridge of  claim 256 , wherein the fitment is adapted to form a fluid-tight seal with a nozzle of the injector. 
     
     
         258 . The cartridge of  claim 257 , wherein the injector is a jet injector and the nozzle of the injector with which the fitment is adapted to engage includes a jet nozzle, and wherein the fitment engages the nozzle to define the aseptic zone through with the first deliverable substance is transferred between the cartridge and the reservoir. 
     
     
         259 . The cartridge of  claim 256 , wherein the fitment is attached to an outer side of one of the first wall and the second wall, the one of the first wall and the second wall including a through hole providing the fluid communication between the first sealed compartment and the passageway of the fitment. 
     
     
         260 . The cartridge of  claim 256 , wherein the fitment further comprises:
 a port area adapted to receive a portion of the injector; and   an aseptic cover protecting the port area when the fitment is not engaged with the injector.   
     
     
         261 . The cartridge of  claim 256 , wherein the fitment further comprises:
 a port area having conformal elements adapted to conform to structural elements of the injector, wherein the conformal elements are adapted to maintain the aseptic zone when the cartridge is engaged with the injector.   
     
     
         262 . The cartridge of  claim 256 , wherein the sealing engagement comprises:
 a first frangible seal between the fitment and the first sealed compartment, wherein the cartridge is adapted to provide the first deliverable substance by the first frangible seal being controllably peelable responsive to depression of the first sealed compartment.   
     
     
         263 . The cartridge of  claim 262 , wherein adherence of the first wall to the second wall in the first frangible seal is less than adherence of the first wall to the second wall in other portions of the sealing engagement. 
     
     
         264 . The cartridge of  claim 262 , further comprising:
 a second sealed compartment containing a second deliverable substance, wherein the second deliverable substance is introduced to the second sealed compartment prior to the sealing engagement of the first wall to the second wall.   
     
     
         265 . The cartridge of  claim 264 , wherein the sealing engagement further comprises:
 a second frangible seal between the first sealed compartment and the second sealed compartment, wherein depressing the first sealed compartment causes peeling of the second frangible seal, the peeling configured to establish fluid communication between the first sealed compartment and the second sealed compartment.   
     
     
         266 . The cartridge of  claim 265 , wherein the second deliverable substance includes one or more of a dry constituent, frozen liquid constituent, granulated constituent, micro-pellet constituent, sphere constituent, microsphere constituent, flowable powder constituent, compressed powder constituent, cake constituent, lyophilized cake constituent or a solid constituent of a beneficial agent and the first deliverable substance includes a fluid and wherein the peeling of the second frangible seal causes mixing of the second deliverable substance with the first deliverable substance. 
     
     
         267 . The cartridge of  claim 266 , wherein the fluid includes a diluent operable to at least partially dissolve the second deliverable substance when the second frangible seal is peeled. 
     
     
         268 . The cartridge of  claim 256 , further comprising:
 a drying agent.   
     
     
         269 . The cartridge of  claim 256 , further comprising:
 a sterile overwrap for storing the cartridge when the cartridge is not engaged with the injector, wherein a drying agent is contained within the sterile overwrap.   
     
     
         270 . The cartridge of  claim 256 , wherein one or more of the first or second wall include a drying agent. 
     
     
         271 . The cartridge of  claim 256 , wherein one or more of the first wall or the second wall are composed of one or more of a film, a foil, an extruded web, a blown web, a cast web, a multilayer web, a laminated web, a coated web, a web including metallicized layers, a web including at least one metal-oxide layer, a web including a high barrier layer, an aluminum containing layer, alumina, silica, an Olefin Polymer, a Cyclic Olefin Copolymer, a polychlorotrifluoroethylene, or an Ethylene Vinyl Alcohol. 
     
     
         272 . The cartridge of  claim 256 , the first wall further comprising at least one optical machine-readable indicium operable to provide information regarding one or more of a content of the cartridge, operating instructions, or warnings. 
     
     
         273 . An injector system, comprising:
 an injector including:
 a tubular body; 
 a piston disposed in the tubular body, wherein the piston provides a fluid-tight seal with the tubular body defining a reservoir within portions of the tubular body not occupied by the piston; 
 a nozzle in fluid communication with the reservoir; and 
   a cartridge including:
 a first wall that comprises at least a first cavity; 
 a second wall in sealing engagement with the first wall to define at least a first sealed compartment at least partially defined by the first cavity, wherein the first sealed compartment is adapted to contain a first deliverable substance; and 
 a fitment engageable with the injector to selectively provide fluid communication between the first sealed compartment and a nozzle of the injector via a passageway of the fitment to transfer the first deliverable substance from the first sealed compartment to a reservoir of the injector, wherein the fitment is engageable with the injector to define an aseptic zone through which the first deliverable substance is transferred between the cartridge and the injector. 
   
     
     
         274 . The injector system of  claim 273 , wherein the injector is a jet injector and the nozzle of the injector with which the fitment is adapted to engage includes a jet nozzle. 
     
     
         275 . The injector system of  claim 273 , wherein the fitment is adapted to form a fluid-tight seal with the nozzle of the injector. 
     
     
         276 . The injector system of  claim 273 , further comprising:
 an aseptic cover maintaining sterility of one or more of the nozzle or the fitment when the cartridge is not engaged with the injector.   
     
     
         277 . The injector system of  claim 276 , wherein the aseptic cover is one or more of a cap or a sealed foil. 
     
     
         278 . The injector system of  claim 273 , wherein the tubular body further comprises:
 structural elements adapted to conform to conformal elements of the fitment, wherein the structural elements are adapted to maintain the aseptic zone when the cartridge is engaged with the injector.   
     
     
         279 . The injector system of  claim 273 , the piston movable within the tubular body, wherein the piston is movable to configurations including an empty state when the piston is at a most proximal position to the nozzle and a retracted state when the piston is moved distally from the nozzle. 
     
     
         280 . The injector system of  claim 279 , wherein the retracted state is a filled state, the filled state resulting from retracting of the piston from the tubular body when the injector is engaged with the cartridge, the retraction causing the first deliverable substance to flow into the reservoir. 
     
     
         281 . The injector system of  claim 273 , wherein one or more of the tubular body or the piston are wrapped in a sterile overwrap. 
     
     
         282 . The injector system of  claim 273 , wherein the injector system is assembled in a sterile environment, the injector is engaged with the cartridge in the sterile environment, and the injector system is provided in a non-sterile environment while maintaining the engagement between the injector and the cartridge in the non-sterile environment. 
     
     
         283 . The injector system of  claim 282 , wherein the engagement maintains the aseptic zone after the injector system is provided in the non-sterile environment.