Abstract A syringe assembly includes a substantially cylindrical syringe barrel (12) and a plunger stopper (30). Distal portions on the plunger stopper are configured to permit outflow of vapor from the syringe barrel during a lyophilization process. Proximal portions of the plunger stopper are dimensioned to engage the syringe barrel in sliding fluid-tight engagement. Liquid medication in the chamber is lyophilized and a vacuum is applied to the syringe barrel after lyophilization. The plunger stopper then is urged distally into sealing engagement with the syringe barrel. A plunger rod (48) can be engaged with the plunger stopper. The tip cap (28) is then removed and a diluent is drawn into the chamber by moving the plunger rod and the plunger stopper in a proximal direction. The syringe assembly then can be used in the standard manner.
A syringe assembly for lyophilizing and subsequently reconstituting an injectable medication, said syringe assembly comprising: a syringe barrel having an open proximal end, a distal end and a substantially cylindrical chamber wall extending therebetween to define a fluid receiving chamber, a passage extending through said distal end and communicating with said chamber; means for releasably sealing said passage to isolate said chamber from the environment; a plunger stopper having opposed proximal and distal ends, at least said distal end of said plunger stopper being disposed in said chamber, at least one vapor passage defined in said plunger stopper and extending from said distal end thereof terminating at a location between said ends of said stopper, said proximal end of said plunger stopper being dimensioned for sliding fluid-tight sealing engagement with said cylindrical chamber wall so that said distal end of said plunger stopper can be engaged in said chamber with said vapor passage enabling escape of vapor from said chamber during lyophilization of said injectable medication, and said proximal end being dimensioned so that said proximal end of said plunger stopper can be urged into sliding fluid-tight engagement with said cylindrical wall of said chamber upon completion of said lyophilization for sealing the lyophilized medication in said chamber, and said plunger stopper subsequently can be urged proximally for reconstituting said lyophilized medication into an injectable form; and mounting means defined at said proximal end of said plunger stopper for engaging a plunger rod.
Claim 2
Dependent Claim
18 words
The syringe assembly of Claim 1, wherein said mounting means of said plunger stopper includes a threaded cavity.
Claim 3
Dependent Claim
48 words
The syringe assembly of Claim 1, further comprising an elongate plunger rod having proximal and distal ends, said plunger rod selectively engageable with said mounting means of said plunger stopper, said plunger rod being dimensioned to project to locations proximally of said proximal end of said syringe barrel.
Claim 4
Dependent Claim
18 words
The syringe assembly of Claim 1, wherein said at least one vapor passage includes a plurality of flutes.
Claim 5
Dependent Claim
11 words
The assembly of Claim 4 wherein said flutes are helically oriented.
Claim 6
Dependent Claim
19 words
The syringe assembly of Claim 1, wherein said vapor passage is defined by a plurality of axially extending ribs.
Claim 7
Dependent Claim
23 words
The syringe assembly of Claim 1 wherein said distal end of said barrel includes a tip projecting distally therefrom and surrounding said passageway.
Claim 8
Dependent Claim
30 words
The syringe assembly of Claim 1 further including sealing means on said plunger rod positioned proximally from said distal end of said plunger rod for sealing said chamber from contamination.
Claim 9
Dependent Claim
18 words
The syringe assembly of Claim 8 wherein said sealing means includes a resilient O-ring around said plunger rod.
Claim 10
Dependent Claim
41 words
The syringe assembly of Claim 1 further including a plug releasably engaging the open proximal end of the barrel to seal and protect the portion of the barrel chamber between the plunger stopper and the open proximal end of the barrel.
References Cited (Backward Citations)
No citation records indexed.
USPTO Annuity & Maintenance Windows
Maintenance schedule is calculated for granted US utility patents.