Bottles and jars – Closures – With means to facilitate closure removal
Utility Patent
1997-08-04
2001-01-02
Shoap, Allan N. (Department: 3727)
Bottles and jars
Closures
With means to facilitate closure removal
C215S249000, C215S302000, C215S307000, C215S310000, C215S274000, C215SDIG003
Utility Patent
active
06168037
ABSTRACT:
I. FIELD OF THE INVENTION
The invention relates to a vial having a resealable connector assembly, and more particularly, to a vial with a resealable connector assembly employing a membrane and pusher for efficient transfer of fluid to or from the vial.
II. BACKGROUND
Dry drugs such as powdered or lyophilized drugs are typically stored in sealed bottles or vials. In practice, the drug is accessed shortly prior to use by rupturing or displacing the seal provided on the vial. A solvent solution such as saline is then introduced into the vial to reconstitute the powdered or lyophilized drug. Once reconstituted, the drug solution is extracted from the vial for use.
Some prior art vials of powdered or lyophilized drugs include a pierceable membrane secured across the open top of the prior art vial. The membrane is normally pierced by a needle in communication with the solvent. However, care must be taken to avoid the separation of membrane fragments when the seal is pierced, as these may be accidentally delivered to the patient. These seals typically must be pierced each time access to the solvent is desired, heightening the problems associated therewith.
Other prior art vials include rubber stoppers that are removed from or urged into the vial when delivering the solvent for reconstituting the drug. While in general these assemblies work well to safely store a lyophilized drug prior to reconstitution and use, the stoppers normally cannot be accessed once they have fallen into the vial; hence, these vials normally cannot be resealed employing the stopper originally provided. This may be problematic, for instance, where a practitioner may not desire or need to administer the entire dose of reconstituted drug held in the vial; the vial would typically need to be resealed against the ambient environment to preserve the sterility of the drug remaining in the vial. Thus, the structure of these prior art vials is not readily adapted to a vial capable of repeated opening and closing.
Stoppers are normally formulated from materials selected for compatibility with the drug stored in the vial. Hence, the stoppers typically pose no harm to the safety of the drug, whether lyophilized or reconstituted. However, the appearance of a stopper within the interior of the vial often leads to the perception—however flawed—that the drug will be adversely affected by the presence of the stopper. There may also be a perception that the presence of the stopper within the vial impedes good flow of the drug solution.
III. SUMMARY OF THE INVENTION
A resealable connector assembly for a vial or bottle is provided for resealable fluid access to and from the interior of a medical storage bottle. The connector assembly permits a practitioner repeated access to the drug held in the bottle while at the same time preserving its sterility. The bottle includes an interior, an open top in fluid communication with the interior, and a top surface disposed around portions of the bottle surrounding the open top. The top surface may be formed, for instance, as an annular rim around the open top.
The resealable connector assembly features a body disposed on the top surface of the bottle. The body defines a recess having a fluid path to and from the open top of the bottle. A fluid access device such as a luer connector hub is disposed on the body to provide fluid access to and from the recess. The luer connector hub includes a connector end configured for access by a component of a medical delivery device, and an opposed end in fluid communication with the recess. If desired, the body and the luer connector hub may be provided as separate components, or they may be integrally formed as one component.
The resealable connector assembly further includes a membrane disposed between the open top of the bottle and the recess defined by the body. The membrane, which may be formed from an elastomeric material such as various elastomers, natural or synthetic rubbers, or the like, preferably includes a central area having a width at least equal to the width defined by the recess. One or more openings or slits are disposed outside the central area to establish in resealable fashion the fluid path between the recess and the open top of the bottle. One or more sealing ribs may be disposed on the body about the periphery of the recess. The sealing ribs are preferably disposed for sealing contact with the membrane between the central area and the one or more openings. If desired, the sealing ribs may be provided on the membrane itself.
The membrane is displaceable between a sealing position, wherein the one or more sealing ribs engage the membrane between the central area and the one or more openings to close the fluid path, and an open position, wherein the one or more ribs are urged away from the membrane, opening the fluid path between the recess and the open top of the bottle.
The membrane may be supported between the body and the top surface of the bottle and held in place, for instance, by an annular clip retaining the body to the top surface of the bottle. If desired, the body and top surface of the bottle may be formed as an integral component, with the membrane secured in the integral component so as to be disposed between the recess and the open top of the bottle.
A pusher is located in the recess defined by the body. The pusher preferably includes a top end disposed adjacent the opposed end of the luer connector hub and a bottom end disposed for contact with the membrane. The pusher defines one or more fluid pathways between its top and bottom ends so as to facilitate fluid flow through the recess. The fluid pathways may be defined by the structure of the pusher; likewise, the pusher may define a width less than the width of the recess, such that a gap exists between the pusher and the recess, establishing the fluid pathway.
If desired, a luer lock seal may be provided which is threadably engageable with the connector end of the luer connector hub. The luer lock seal serves to preserve sterility and prevents inadvertent access to the interior of the bottle until use is desired.
In use, the luer lock seal (if provided) is removed by the practitioner, so that the connector end of the luer connector hub is disposed for access by the medical delivery device. The medical delivery device may feature a male luer tip which is insertable through the connector end of the luer connector hub. The male luer tip will exert a force against the pusher, such that the pusher will displace the membrane towards the interior of the bottle. The one or more ribs will be displaced from their sealing contact with the body, opening the fluid path between the recess and the open top of the bottle, and thereby permitting fluid flow between the medical delivery device and the interior of the bottle via the recess and the fluid path defined between the recess and the open top of the bottle. Upon removing the medical delivery device from contact with the pusher, the membrane will re-deflect towards its closed position, such that the one or more ribs will be re-disposed for sealing contact with the membrane, closing the fluid path.
The pusher may assume a variety of configurations. Notably, the pusher may be formed as an elongate plug having a top end disposed through the opposed end of the luer connector hub, and a bottom end disposed for contact with the membrane. At least one outwardly protruding notch may be formed between the top and bottom ends of the plug. The recess may be formed with a main portion and top and bottom ends that display a width narrower than the width of the main portion. The width defined by the notch is greater than the width of the top and bottom ends of the recess. Thus, the notch serves to prevent inadvertent withdrawal of the plug from the recess. Moreover, the notch may cooperate with either the top or bottom ends of the recess as a second way to seal the device.
REFERENCES:
patent: 2607503 (1952-08-01), Sonnenberg
patent: 2953132 (1960-09-01), Richter et al.
patent: 3164303 (1965-01-01), Trautmann
patent: 3206080 (1965-09-01), S
Becton Dickinson France S.A.
Eloshway Niki M.
Shoap Allan N.
Wark Allen W.
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