Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-09-23
2001-07-17
McDermott, Corrine (Department: 3734)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S246000, C604S905000, C604S415000
Reexamination Certificate
active
06261270
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to sleeves used with containers and tubing sets, and more particularly to an improved sleeve stopper which is configured to preclude telescopic nesting of adjacent stoppers during the manufacture and handling thereof.
BACKGROUND OF THE INVENTION AND TECHNICAL PROBLEMS POSED BY THE PRIOR ART
Sleeve-like stoppers are widely used in association with tubing sets and containers used in the administration of intravenous solutions to patients. These types of stoppers ordinarily include a pierceable membrane portion and a side wall portion. The stopper is attached to a port on the tubing set, container, or other device such that the pierceable membrane sealingly covers the port. The side wall portion retains the pierceable membrane portion on the port. Fluids can be introduced into and/or withdrawn from the tubing set, container, or device by inserting a piercing member, e.g., a needle or a cannula, through the pierceable membrane, thereby providing fluid communication between the interior of the tubing set, container, or device and the exterior environment thereof.
In medical applications, sleeve stoppers of this type allow medical personnel to withdraw finite amounts of fluid from the tubing set or medical container without compromising the sterility of the fluid. It will be appreciated that standard medical cannulas, including, but not limited to, hypodermic syringes, can be used to pierce the pierceable membrane and provide the necessary fluid communication across the membrane. Such stoppers are particularly useful in connection with the addition of fluids into tubing sets and medical containers. For example, when used in connection with a Y-port on a medical tubing set, as depicted in
FIG. 1
, the sleeve stopper can be used to seal an “add port” on the Y-port device. A medical professional can introduce a secondary fluid into the tubing set for delivery to a patient by simply inserting a piercing member through the pierceable membrane and flowing a fluid into the tube set. Sleeve stoppers of this type also are useful to dilute medicaments or to facilitate the mixing of two or more fluids in containers of known construction.
A heretofore known sleeve stopper of the above-discussed type has a generally stepped, cylindrical configuration, including male and female portions. The male portion is configured to be received within a tubular port of a tubing set or a container, while the female portion, in turn, is of a relatively larger size and is configured to receive therein a wall defining tubular port. In this way, the sleeve stopper can be used to fluidly seal a port associated with the tubing set or container. In such an arrangement, the male portion has an outside diameter at its free end which is less than the inside diameter of the end of the female portion when the sleeve stopper is in its first position, that is, the position reflected in FIG.
2
.
By virtue of this relative dimensioning, a problem can occur attendant to manufacture and handling of adjacent sleeve stoppers. In particular, undesired “snaking” of the stoppers can occur when the male portion of one stopper telescopically nests within the female portion of an adjacent stopper. This effect can create an elongated “snake” of stopper parts, and can detract from efficient operation of automatic handling equipment.
SUMMARY OF THE INVENTION
The present invention is directed to a sleeve stopper which has been particularly configured to avoid the problem of “snaking” heretofore exhibited during the automatic handling of previously known sleeve stoppers. In particular, the present sleeve stopper is configured such that a male portion of the stopper is dimensioned so that it cannot be readily received within the female portion of an adjacent stopper. This arrangement significantly reduces the possibility of the nesting or snaking of adjacent sleeve stoppers, thereby promoting efficient/economical handling with automated equipment.
In accordance with the illustrated embodiment, the present sleeve stopper comprises a stopper body having a central membrane portion constructed of a pierceable material. In one embodiment, the pierceable material is selected such that it reseals itself upon the withdrawal of a piercing member therefrom. The stopper body further includes a female portion extending from one side of the membrane portion. The body also includes a male portion which extends from an opposite side of the membrane portion. The female portion is constructed such that it substantially surrounds an exterior wall of the male portion when the stopper body is in use, i.e., when the stopper body is in its second position.
In one embodiment, each of the male and female portions comprises a respective annular wall defining an interior passage. The passages are separated and fluidly sealed from one another by the membrane portion, with the passages being fluidly connected when a piercing member, e.g., a needle or a cannula, pierces the membrane portion. In accordance with the present invention, the annular wall of the female portion defines an inside diameter D
1
at a free end thereof when the stopper body is in its first position, while the annular wall of the second, male portion defines an outside diameter D
2
at the free end portion thereof. The outside diameter D
2
of the male portion is greater than the diameter D
1
of the female portion to thereby preclude telescopic nesting of adjacent sleeve stoppers. This promotes efficient handling with automated equipment.
In the illustrated embodiment, the membrane portion includes an annular indicia or target positioned adjacent to the passage defined by the annular wall of the female sleeve portion. This target facilitates connection of associated components by directing a user to the appropriate location for piercing the membrane portion.
An annular wall of the female portion defines a relatively thick, annular bead on the free end portion thereof, with the annular bead defining the diameter D
1
. To promote efficient manufacture, the walls of male and female portions preferably are tapered. Specifically, the annular wall of the female portion tapers inwardly in a direction toward the membrane portion when the body portion is in the first position, while the annular wall of the male portion tapers inwardly in a direction away from the membrane portion.
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Gault Donald L.
Sergot John F.
Shull Max W.
Talese Gregory P.
Titus, Jr. Richard A.
Abbott Laboratories
McDermott Corrine
Rodriguez Cris L.
Woodworth Brian R.
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