Apparatus for Dispensing Medicinal Fluids and Method of Making Same

An apparatus for dispensing medicinal fluids to a patient comprising:

• (a) A generally cylindrically shaped housing having first and second ends and a longitudinally extending center line;
• (b) a first assembly connected to said first end of said housing, said first assembly comprising:
• (i) a front cover;
• (ii) a unitary fluidics hub disposed within said front cover, said unitary fluidics hub having a sidewall defining a central bore, a closure wall and a penetrating member connected to said closure wall and extending into said central bore, said penetrating member having a fluid passageway;
• and
• (iii) a rate control for controlling the rate of flow of medicinal fluids to the patient, said rate control comprising a spiral micro-channel formed in said closure wall of said unitary fluidics hub, said spiral microchannel having an inlet in communication with said fluid passageway of said penetrating member;
• (c) a second assembly carried by said housing for movement relative thereto between a first position and a second advanced position, said second assembly comprising:
• (i) a threaded shuttle;
• (ii) a collapsible container carried by said threaded shuttle, said collapsible container including a neck portion having a closure wall pierceable by said penetrating member and having a longitudinal center line aligned with said longitudinal center line of said housing;
• and
• (iii) a split connector ring interconnecting said threaded shuttle and said collapsible container, said split connector ring including a plurality of circumferentially spaced, outwardly extending securement legs, removably connected to said threaded shuttle, each said securement leg having a gripping segment constructed and arranged to releasably grip said shuttle.
• (d) a first operating assembly operably associated with said second assembly for controlled movement of said second assembly within said housing from said first position to said second advanced position;
• (e) a second operating assembly operably associated with said second assembly for controllably advancing said second assembly within said housing from said second advanced position to a further advanced position;
• and
• (f) a disabling assembly carried by said generally cylindrically shaped housing for preventing operation of said first operating assembly of said second assembly, said disabling assembly comprising a thin-film encapsulating said generally cylindrically shaped housing.

A method for infusing medicinal fluids into a patient using an apparatus for dispensing medicinal fluids comprising a housing, a penetrating member carried within said housing, a rate control assembly carried within said housing and having a micro-channel in communication with said penetrating member, an administration set carried by said housing and in communication with said micro-channel, a threaded shuttle carried within said housing and movable between a first position and a second position, a collapsible container carried by said threaded shuttle, said collapsible container containing the medicinal fluids to be dispensed to the patient and including a closure wall pierceable by said penetrating member, an end cap threadably connected to said housing and operably associated with said shuttle for moving said shuttle between said first and second positions, a variable force spring carried by said housing and operably associated with said shuttle for advancing said shuttle to a third advanced position and a thin-film encapsulating said housing and a portion of said end cap, said method comprising the steps of:

• (a) removing said thin-film from said housing;
• (b) connecting said administration set to the patient;
• (c) rotating said end cap relative to said housing to advance said shuttle to said first position;
• (d) using said variable force spring to further advance said shuttle within said housing to cause said penetrating member to penetrate said closure wall of said container;
• and
• (e) using said variable force spring to collapse said container and cause fluid to flow through said micro-channel of said rate control assembly and toward said administration line.