Stopper for sealing infusion bottles

Details Stopper for sealing infusion bottles Stopper for sealing infusion bottles

1998-12-09

2001-06-05

Newhouse, Nathan J. (Department: 3727)

Bottles and jars

Closures

Self-sealing, piercable-type closure

C215S355000, C215SDIG003

Reexamination Certificate

active

06241112

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a stopper for sealing containers holding pharmaceutical liquids, especially to a stopper for infusion bottles, which stop per has a collar, which projects into the neck of the container; an edge, which rests on the neck of the container; and a puncture area, which is enclosed by the edge and the collar, the stopper being held on the neck of the container by a protective cap made out of metal or plastic.
BACKGROUND OF THE INVENTION
Stoppers of this type to which the present invention relates is for infusion bottles are described in, for example, DE 3,241,283 C3, DE 4,135,470 A1, DE 4,228,090 C2, and DE 4,344,134 A1. All of them have a collar which is very long in comparison to the edge and also to the thickness H
1
of the puncture area, with the result that the collar projects quite far into the neck of the bottle. In addition, the top surface of the puncture area is uniform in height and is level with the edge of the stopper. In these known stoppers for infusion bottles, the puncture area is relatively thick; this is done to prevent the puncture needle of the infusion kit from sliding out of the stopper under its own weight and the weight of the infusion liquid present in it, in the drip chamber, and in the tubing connected to the needle after the infusion bottle has been hung upside down. In this context, reference can be made to the standards DIN 38,363 and ISO 8,536.2, which pertain to these types of sealing stoppers, also called “hollow stoppers”. In the test of the strength with which the puncture needle is held in the stopper according to the DIN standard, the test needle may not slide out of the stopper for 5 hours under an additional load of 0.5 kg. To ensure, therefore, that a sufficient amount of lateral pressure can be exerted on the inserted needle and to increase the friction between the surface of the needle and the surface of the hole formed in the puncture area of the stopper by the puncture, the puncture area of stoppers of this type is made quite thick, so that it is held relatively rigidly between the edge and the collar. The disadvantage of this stopper is that a relatively large amount of force is required to push the relatively thick puncture needle of an infusion kit through it. In this regard, furthermore, the above-cited standards, especially the DIN standard, specify that, in the test of the puncturability of the stopper, the force required to push the needle through the stopper may not exceed 100 N.
Against the background of these known stoppers for infusion bottles, it is therefore the goal of the present invention to design a stopper of the general type in question in such a way that much less effort is required to push the puncture needle of an infusion kit through the stopper, which means that, even though the puncture area of the stopper is much thinner, the infusion kit is nevertheless securely held by the stopper on the upside-down infusion bottle and thus prevented from sliding out.
SUMMARY OF THE INVENTION
This goal is achieved with a stopper of the type described above in that the puncture area is designed with such elasticity and flexibility with respect to the edge and the collar that it bulges slightly outward after the stopper has been inserted into the neck of the container, whereas, after the puncture needle has been pushed through the stopper, the puncture area bulges down into the neck of the container.
This flexible design of the puncture area of the stopper means that, after the stopper has been inserted into the neck of the container, it is under a state of tension because of its outward bulge; the collar thus exerts pressure on the inside surface of the container neck. This results in a sealing action on the neck, which remains in effect even after the infusion bottle has been hung upside down. As soon as the puncture needle is pushed through the puncture area in the stopper, however, the outward bulge of the puncture area is changed into an inward bulge, directed down into the interior of the container. Thus, as a result of the thickening of the material caused by the insertion of the puncture needle, the strength with which the collar adheres to the inside surface of the container neck is increased even more. The inward bulge of the punctured puncture area downward into the interior of the container reinforces the holding action on the puncture needle when the infusion bottle is placed upside down. From the viewpoint of statics, the puncture area of the stopper is supported like an arch between the outside surface of the puncture needle at one end and the collar or inside surface of the container neck at the other, and the weight of the infusion kit merely increases these forces.
To give the stopper according to the invention this property of flexibility, the top surface of the puncture area is made lower than the top surface of the edge. Because the puncture area is intentionally made lower than the edge, it acquires the previously described ability to bulge inward and outward.
Another factor which contributes to this ability is that the bottom surface of the stopper inside the collar is relatively flat and essentially parallel to the surface of the puncture area. This design of the puncture area of the stopper provides the flexibility required for the proper action of the stopper in its function as a seal for infusion bottles in conjunction with an infusion kit.
This flexibility of the stopper is also promoted by the fact that the length of the collar projecting downward beyond the bottom surface of the puncture area is almost the same as the thickness of the puncture area. By making the collar smaller that the collars of conventional stoppers, it is possible for the force acting on the stopper by virtue of the flexibility and elasticity of the puncture area of the stopper to act more effectively on the collar, and, even though the contact area of the collar against the inside surface of the container neck is smaller than that of conventional stoppers, it can nevertheless provide the necessary sealing and retaining functions.
It has been found that the stopper according to the invention, because of its design as described above and the properties attributable to that design, is able to offer not only the advantages presented above but also the advantage of much smaller dimensions than those of conventional stoppers for infusion bottles. As a result, the amount of material required to produce such stoppers is decreased, which has advantageous effects on production, since the stopper is, after all, a mass-produced item.


REFERENCES:
patent: 3193128 (1965-07-01), Ravn
patent: 3358865 (1967-12-01), Andersen
patent: 3587897 (1971-06-01), Rohde
patent: 3653528 (1972-04-01), Wimmer
patent: 4244478 (1981-01-01), Handman
patent: 5165560 (1992-11-01), Ennis, III et al.
patent: 5588547 (1996-12-01), Derksen
patent: 2065925 (1992-10-01), None
patent: 1616183 (1968-02-01), None
patent: 2041740 (1970-08-01), None
patent: 3241283 CS (1982-11-01), None
patent: 3638928 (1988-05-01), None
patent: 4135470A1 (1991-10-01), None
patent: 4228090CS (1992-08-01), None
patent: 4344134 A1 (1993-12-01), None
patent: 0680889A1 (1995-04-01), None
patent: 1282024 (1962-03-01), None
patent: WO-88/06556 (1988-09-01), None
patent: 94/15850 (1994-07-01), None

Affiliated with

Also associated with

Rating

Stopper for sealing infusion bottles does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Stopper for sealing infusion bottles, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Stopper for sealing infusion bottles will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFUS-PAI-O-2473845