Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-07-17
2001-02-27
Yasko, John D. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06193688
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a tamper evident protector cap for a pre-filled syringe barrel. More particularly, the invention relates to a cap for a syringe barrel containing a liquid medication therein for securely holding a closure in the tapered tip of the syringe barrel and serving as a tamper evident indicator.
2. Reported Developments
Pre-filled syringe barrels or cartridges containing injectable solutions therein are stoppered by elastomeric closures, such as soft rubber stoppers at the distal, tapered end thereof, while the proximal end of the barrels are closed by slidable plungers. The pre-filled syringe barrels or cartridges are sterilized, such as by autoclaving, and packaged ready for use.
It has been observed that during in-line processing, handling, and sterilizing the pre-filled barrels some elastomeric closures were missing from the tips of the barrels resulting in rejects. Also, during shipment of the finished product and handling by healthcare professionals some untipped barrels were observed which necessitated the discarding of batches containing failed samples. For product integrity a corrective measure was indicated to prevent the elastomeric closure from becoming dislodged from the tip of the barrel.
More importantly, it has also been recognized that untipped barrels (whether the damage occurred during shipment or handling) attracts the suspicion that the product was tampered with. Such possible tampering is a concern for both the FDA and the manufacturers who are required to insure safety, efficacy and product integrity.
SUMMARY OF THE INVENTION
In accordance with the present invention a protective cap is provided for a syringe or cartridge barrel. The syringe or cartridge barrel, comprising a cylindrical chamber containing a pharmaceutical or biological liquid in the form of an injectable solution, terminates in a tapered tip having a bore therethrough. The tapered tip is equipped with a female luer connector barrel to which a male luer connector or an injection needle may be attached. The bore in the tapered tip is stoppered by an elastomeric closure, such as a soft rubber plug. The protective cap covering the tapered tip comprises a cylindrical top portion; and a bottom skirt portion having: two semi-circular walls facing each other and spaced 180° from each other; and two frangible brackets facing each other and spaced 180° from each other, each of the brackets terminating in a horizontal leg adapted to engage the female luer connector barrel. The two semi-circular walls provide strength and rigidity to the protector cap, while the brackets are designed to disengage the female luer connector barrel thereby allowing easy removal of the protector cap. At the point of disengagement the brackets break away from the skirt portion of the protector cap indicating that the protector cap has been removed from the tip of the syringe or cartridge barrel.
REFERENCES:
patent: 4667837 (1987-05-01), Vitello et al.
patent: 4886497 (1989-12-01), Scholl, Jr.
patent: 5328474 (1994-07-01), Raines
patent: 5624402 (1997-04-01), Imbert
Balestracci Ernest
Niedospial Jr. John J.
Balogh Imre
Bracco Diagnostics Inc.
Yasko John D.
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