Chemical apparatus and process disinfecting – deodorizing – preser – Control element responsive to a sensed operating condition
Reexamination Certificate
2001-03-07
2003-12-02
Warden, Jill (Department: 1743)
Chemical apparatus and process disinfecting, deodorizing, preser
Control element responsive to a sensed operating condition
C422S091000, C422S105000, C422S105000, C073S864740, C073S864410, C215S247000, C215S319000, C234S128000
Reexamination Certificate
active
06656433
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates generally to vial access devices, and more particularly to an adaptor device for use with conventional pierceable-septa vials of different sizes to provide needle-less access to the interior thereof.
Conventional vials for containing drugs and the like typically comprise a cylindrical glass body closed at the bottom and terminating upwardly at a narrowed neck to an opening. The opening is closed or covered by a cap. The cap is usually formed of metal includes a pierceable septum formed of an elastomeric material, such as latex rubber or the like. The septum is arranged to be pierced by a sharp cannula or needle to either introduce or withdraw a fluid into/out of the vial. Upon withdrawal of the cannula
eedle the septum reseals itself to maintain a sterile environment in the vial.
Various devices have been disclosed in the patent literature for penetrating the septum of a drug vial. For example, in U.S. Pat. Nos. 5,839,715 (Leinsing) and 6,142,446 (Leinsing) there is disclosed medical adaptors having both a needleless valve and a sharpened cannula for use with pierceable septa containers, e.g., drug vials, or other devices having different sizes. The adaptor includes a needle-less site at one end and a sharpened cannula at the other end protected by spring arms. The arms include claws at their distal ends to grasp the neck of the vial to which the sharpened cannula is to be inserted. The claws include sharpened points for gripping the device. The arms are located on either side of the adaptor body and are connected to the body through springs. Handles are also included on the arms for use by the operator to separate the arms against the spring forces during engagement of the adaptor with the septum. In one case, the handles include finger grips located above the springs for pressing the handles inward to open the arms and claws and in another case, the handles are located closer to the distal ends of the arms for pulling the arms outward. The adaptor in one case comprises only three parts for reduced materials and manufacturing expense.
Other adaptors for accessing the interior of a pierceable septum drug vial are found in U.S. Pat. No. 5,393,497 (Haber), U.S. Pat. No. 5,429,614 (Fowles et al.), and U.S. Pat. No. 6,113,583 (Fowles et al.).
While the foregoing devices may be suitable for their intended purposes they never the less leave something to be desired from one or more of the standpoints of simplicity of construction, easy of use, ability to be used with various size vials, and protection from accidental sticking of personnel.
SUMMARY OF THE INVENTION
An adaptor device for respective releasable mounting on first and second vials, e.g., drug vials, to provide needle-less access to the interior of each vial. Each vial is of conventional construction, e.g., a cylindrical glass body having a closed bottom and terminating upwardly at a narrowed neck to an opening that is closed by a cap that includes a pierceable septum formed of an elastomeric material. The cap includes a cylindrical rim of predetermined outside diameter that surrounds the septum. The predetermined outside diameter of the rim of the first vial is smaller than the predetermined outside diameter of the rim of the second vial.
The adaptor device comprises a longitudinal central axis along which a piercing member, e.g., sharpened cannula, extends and a peripheral sidewall surrounding the piercing member. The piercing member is hollow and terminates at a sharpened end arranged to pierce through the septum of the vial to which the device is releasably mounted. The peripheral sidewall includes an upper portion having a circular inner surface centered around the piercing member and a lower skirt flaring outward from the upper portion. The skirt terminates in a peripheral free edge extending beyond the sharpened end of the piercing member.
The peripheral sidewall of the adaptor includes a plurality, e.g., six, of slits extending upward from the peripheral edge of the skirt to enable portions of the sidewall between those slits to flex outward. The sidewall also includes plural equidistantly spaced projections, e.g., two groups of three projections each, extending radially inward adjacent the inner surface of the upper portion of the sidewall to form a ledge. These projection are resiliently mounted on the sidewall to enable the cap of the first vial to pass between the projections and then return to a position wherein the ledge has inside diameter just slightly less than the outside diameter of the rim of the first vial to form a seat on which the rim of the first vial may sit to releasably secure the adaptor to the cap of the first vial, and with the rim of the first vial being adjacent the inner surface of said sidewall and the sharpened end of the piercing member piercing through the septum of the first vial. The resilient mounting of the projections also enables the cap of the second vial to pass between the projections and then return to a position wherein the ledge has an inside diameter just slightly less than the outside diameter of the rim of the second vial to form a seat on which the rim of the second vial may sit to releasably secure the adaptor to cap of the second vial, with the rim of the second vial being adjacent the inner surface of the sidewall and with the sharpened end of the piercing member piercing through the septum of the second vial.
In accordance with one exemplary preferred embodiment of this invention the adaptor includes a top wall having a peripheral edge from which the sidewall projects and a tubular member secured to the top wall and extending along the longitudinal axis. The tubular member has a central passageway in fluid communication with the hollow piercing member to enable needle-less transfer of fluid therethrough.
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Caesar Rivise Bernstein Cohen & Pokotilow Ltd.
Churchill Medical Systems, Inc.
Gordon Brian R.
Warden Jill
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