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US 2025/0152833 A1Published application
Syringe and gasket systems
AssigneeSio2 Medical Products, Inc.
InventorsRobert S. Abrams, Kenneth Wade Kelly, Ahmad Taha, Benjamin Hunt, Brian Russell Lilly, Ralf Kibele
Life of this patent
Estimating the term…
Abstract
A process for producing gaskets with an improved channel for use in matched syringe and plunger systems, preferably prefilled plastic syringe systems. In particular, an improved process for making and inspecting continuous channels in a gasket film by laser treatment. The gaskets are useful in matched syringe and plunger systems with high and consistent container closure integrity (CCI), and consistent break loose and glide forces over time, and sealability.
Claims20
1-28. (canceled).
A matched syringe and plunger system comprising:
- (a) a tubular syringe barrel;
- (b) a plunger located inside the syringe barrel and being reciprocally movable longitudinally in the barrel;
- and
- (c) a gasket attached to the distal end of the plunger;
- the gasket comprising a main body made of an elastic material, the main body having a circumferential outer surface portion and an internal cavity in its center, the cavity being defined by an inner surface portion of the gasket and being open at one end, wherein the gasket is characterized by one or more continuous channels, the channels extending around the entire circumference of a circumferential outer surface of the gasket, and wherein the one or more continuous channels are made according to a process comprising the following steps:
- (i) inserting a portion of one end of a mandrel into the open end of the cavity;
- (ii) securing the gasket to the mandrel;
- (iii) positioning the mandrel and secured gasket in proximity to a laser;
- and
- (iv) applying a laser beam emitted from the laser to one or more selected locations on a surface portion of a film residing on the circumferential outer surface portion of the gasket while rotating the mandrel and the secured gasket along the mandrel's longitudinal axis to produce the one or more continuous channels in the gasket, the channels extending around the entire circumference of a circumferential outer surface of the gasket.
7 more elements
(canceled).
(canceled).
A gasket comprising
- (a) a main body made of an elastic material, the main body having a circumferential surface portion and an internal cavity, the cavity being defined by an inner surface portion of the gasket and being open ended at one end;
- (b) a film residing on at least a circumferential outer portion of the gasket;
- and
- (c) one or more continuous channels in the film, the channels extending around the entire circumferential outer surface of the subject;
- wherein the gasket has one or more of the following characteristics:
- (i) a container closure integrity (CCI) when assembled within a matched syringe and plunger system with a defect rate of no more than 6-sigma;
- (ii) a break loose force between 4 and 20 Newtons (N) when assembled within the matched syringe and plunger system;
- (iii) a glide force between 4 and 20 Newtons (N) when assembled within the matched syringe and plunger system;
- wherein one or more of the break loose force or the glide force changes less than about 10-30% over a two-year storage life.
6 more elements
A matched syringe and plunger system comprising:
- (a) a tubular syringe barrel;
- (b) a plunger located inside the syringe barrel and being reciprocally movable longitudinally in the barrel;
- and
- (c) a gasket attached to the distal end of the plunger by a press-fit assembly, the gasket comprising a main body made of an elastic material, the main body having a circumferential outer surface portion and an internal cavity in its center, the cavity being defined by an inner surface portion of the gasket and being open at one end, wherein the gasket is characterized by a film residing on at least a circumferential outer portion of the gasket and one or more continuous channels, the channels extending around the entire circumference of a circumferential outer surface of the gasket, and
- wherein the matched syringe and plunger system is characterized by one or more of:
- (a) a container closure integrity (CCI) with a defect rate of no more than 6-sigma;
- (b) a break loose force between 4 and 20 Newtons (N);
- and
- (c) a glide force between 4 and 20 Newtons (N);
- and
- wherein one or more of the break loose force or the glide force changes less than about 10-30% over a two-year storage life.
8 more elements
Dependencies are inferred from the claim text.