Syringe and method for lyophilizing and reconstituting injectable medication
First Claim
1. A 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 having an inside surface, 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 and an outer surface, at least said distal end of said plunger stopper being disposed in said chamber, at least one vapor passage defined between the inside surface of said chamber wall and said outer surface of said plunger stopper, said vapor passage extending from said distal end of the plunger stopper and terminating at a location between said ends of said stopper, said proximal end of said 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 a first lyophilization operation of said injectable medication introduced into the syringe barrel, 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 a second reconstitution operation of said lyophilized medication into an injectable form; and
mounting means defined at said proximal end of said plunger stopper for engaging a plunger rod.
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Accused Products
Abstract
A syringe assembly includes a substantially cylindrical syringe barrel and a plunger stopper. 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 can be engaged with the plunger stopper. The tip cap 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.
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Citations
20 Claims
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1. A syringe assembly comprising:
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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 having an inside surface, 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 and an outer surface, at least said distal end of said plunger stopper being disposed in said chamber, at least one vapor passage defined between the inside surface of said chamber wall and said outer surface of said plunger stopper, said vapor passage extending from said distal end of the plunger stopper and terminating at a location between said ends of said stopper, said proximal end of said 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 a first lyophilization operation of said injectable medication introduced into the syringe barrel, 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 a second reconstitution operation of said lyophilized medication into an injectable form; and mounting means defined at said proximal end of said plunger stopper for engaging a plunger rod. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method for lyophilizing and subsequently reconstituting an injectable medication, said method comprising the steps of:
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providing a syringe barrel with an open proximal end, a distal end and a cylindrical chamber wall extending therebetween and defining a fluid receiving chamber having an inside surface, a tip projecting from said distal end of said syringe barrel and having a passage extending therethrough and communicating with said chamber; sealing said passage in said tip; placing a liquid medication in said chamber; providing a plunger stopper having proximal and distal portions and an outer surface, distal portions of said plunger stopper being configured to define at least one vapor passage between the inside surface of said chamber wall of the syringe barrel and the outer surface of said plunger stopper, said proximal portions of said plunger stopper being configured for sliding fluid-tight engagement with said syringe barrel, said proximal end of said stopper including means for engaging a plunger rod; inserting said distal end of said plunger stopper into said proximal end of said syringe barrel; subjecting said liquid medication to a lyophilizing operation; urging said plunger stopper distally into said syringe barrel, such that proximal portions of said plunger stopper seal the lyophilized medication in said chamber; removing the seal from said tip; placing the passage of said tip in communication with a diluent; and urging said plunger stopper proximally for drawing a selected amount of said diluent into said chamber for reconstituting said lyophilized medication. - View Dependent Claims (18, 19, 20)
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Specification