Cartridge assembly for a lyophilized compound forming a disposable portion of an injector pen and method for same
First Claim
1. A method of lyophilizing and sealing an injectionable product within a cartridge, the method comprising the steps of:
- providing an elongate cartridge having on a first end thereof a shoulder, a rim defining a first opening and having a circumferential radially outwardly extending flange adjacent said first opening, and a neck disposed axially between said flange and shoulder, said neck having a diameter smaller than said flange and shoulder, said cartridge including a second opening on a second end thereof distal said first opening;
inserting a plunger in said second opening;
providing a cap having a cylindrical portion and a seal, said cylindrical portion including an open bottom receivable over said neck, said cap including a top having an opening therein for receipt of a needle therethrough, at least one vent circumferentially disposed in said cap, and at least two deformable ledges on said cap extending radially inwardly from said cylindrical portion axially below said vent, said seal being axially disposed between said vent and said top so as to block said top opening;
inserting the product to be lyophilized into said cartridge;
placing said cap onto said cartridge such that said deformable ledges rest upon said flange and said vent is in fluid communication with said cartridge first opening;
placing said cartridge with said cap in a lyophilizing chamber;
lyophilizing the product; and
closing said cap by exerting a downward pressure upon said cap such that said deformable ledges yieldably snap around said flange and into said neck to be lockingly retained therein, said vent is blocked from communication with said cartridge first opening, and said seal is pressed into sealing engagement with said rim by downward pressure exerted by said top thereby providing an air impermeable barrier between said top opening and said cartridge first opening.
1 Assignment
0 Petitions
Accused Products
Abstract
A cartridge assembly for holding a lyophilized product, forming a disposable portion of a pen injector includes a cylindrical glass cartridge adapted to receive the product, a closure cap, a cartridge case, and a plunger mechanism. The closure cap is adapted to retain an elastomeric disc seal during lyophilization and includes diametrically opposed ledges. The closure cap and seal are adapted to cover a neck portion of the ampule, the neck portion having on its end a radially extending circumferential flange. The ledges of the closure cap and the flange of the neck portion allow the closure cap to remain open during lyophilization, oxygen purge and nitrogen overlay. An oval-shaped indentation formed on the inside of the closure cap aids in snapping the closure cap about the flange without crimping to retain the closure cap underneath the flange. Reconstitution of the lyophilized drug is accomplished without foaming by use of an obliquely angled connector which causes the diluent to indirectly impinge on the drug. The injection pen and cartridge assembly cooperate such that the length of travel of the plunger rod during retraction is less than the axial length of a recess in the rod tip.
146 Citations
23 Claims
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1. A method of lyophilizing and sealing an injectionable product within a cartridge, the method comprising the steps of:
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providing an elongate cartridge having on a first end thereof a shoulder, a rim defining a first opening and having a circumferential radially outwardly extending flange adjacent said first opening, and a neck disposed axially between said flange and shoulder, said neck having a diameter smaller than said flange and shoulder, said cartridge including a second opening on a second end thereof distal said first opening; inserting a plunger in said second opening; providing a cap having a cylindrical portion and a seal, said cylindrical portion including an open bottom receivable over said neck, said cap including a top having an opening therein for receipt of a needle therethrough, at least one vent circumferentially disposed in said cap, and at least two deformable ledges on said cap extending radially inwardly from said cylindrical portion axially below said vent, said seal being axially disposed between said vent and said top so as to block said top opening; inserting the product to be lyophilized into said cartridge; placing said cap onto said cartridge such that said deformable ledges rest upon said flange and said vent is in fluid communication with said cartridge first opening; placing said cartridge with said cap in a lyophilizing chamber; lyophilizing the product; and closing said cap by exerting a downward pressure upon said cap such that said deformable ledges yieldably snap around said flange and into said neck to be lockingly retained therein, said vent is blocked from communication with said cartridge first opening, and said seal is pressed into sealing engagement with said rim by downward pressure exerted by said top thereby providing an air impermeable barrier between said top opening and said cartridge first opening. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A cartridge assembly for holding a lyophilized drug and forming a disposable part of an injection pen, the cartridge assembly comprising:
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an elongate cartridge having on a first end thereof a shoulder, and a rim defining a first opening and having circumferential radially outwardly extending flange adjacent said first opening and a neck disposed axially between said flange and shoulder, said neck having a diameter smaller than said flange and shoulder, said cartridge including a second opening on a second end thereof distal said first opening; a cap disposed on said first end of said cartridge, said cap having a first cylindrical portion including an open bottom received over said first end, a top having an opening therein for receipt of a needle therethrough, and at least two elastically deformable ledges extending radially inwardly from said first cylindrical portion and lockingly retained under said neck flange; a resilient seal in said cap disposed between said first opening and said top opening and forming an impermeable barrier therebetween; a sleeve radially disposed about and permanently attached to said cap; and a plunger rod tip slidably disposed in said sleeve, said plunger rod tip including a head axially adjacent said plunger for exerting pressure against said plunger during administration of the drug. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15, 16, 23)
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17. A cap and cartridge assembly for lyophilizing a drug within the cartridge and sealing the cartridge after lyophilization, the cartridge having a first end defining a first opening therein, the first end including a circumferential radially outwardly extending flange adjacent the first opening, said cap including a reduced diameter neck adjacent said flange, the cap comprising:
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a first cylindrical portion having an open bottom end receivable over said cartridge first end; a top having an opening therein for receipt of a needle therethrough; at least one vent opening circumferentially disposed in said first cylindrical portion; said first cylindrical portion having an oval-shaped inner wall and a deformable ledge in said cap on said oval-shaped wall and extending radially inwardly at a position axially below said vent, said ledge being disposed generally on the minor axis of the oval; said cap adapted for a first position during lyophilization whereby said deformable ledge rests upon the flange of the cartridge such that said vent is in communication with the cartridge opening, said cap adapted for a second position after lyophilization whereby said deformable ledge yieldably snaps around the flange such that said deformable ledge is lockingly retained thereunder in the neck, said vent is closed from communication with the cartridge opening, and the seal is compressed into sealing engagement with the cartridge opening by downward pressure exerted by said top thereby providing an air impermeable barrier between said top opening and the cartridge opening. - View Dependent Claims (18, 19, 20, 21, 22)
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Specification