U.S. patent number 3,653,528 [Application Number 05/016,154] was granted by the patent office on 1972-04-04 for stopper for medicament flasks.
This patent grant is currently assigned to The West Company. Invention is credited to Hans Wimmer.
United States Patent |
3,653,528 |
Wimmer |
April 4, 1972 |
STOPPER FOR MEDICAMENT FLASKS
Abstract
A stopper adapted to be held in place in an opening in a
container by means of an outer cap member comprising a disc-like
top portion having an enlarged outer annular wall section and an
inner radial wall section of smaller cross section than the outer
wall, means defining at least one indentation in the outer surface
of the top portion adapted to be pierced by a hypodermic needle or
the like.
Inventors: |
Wimmer; Hans (Vicht,
DT) |
Assignee: |
The West Company (Phoenixville,
PA)
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Family
ID: |
21775683 |
Appl.
No.: |
05/016,154 |
Filed: |
March 3, 1970 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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801914 |
Jan 28, 1969 |
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697749 |
Jan 5, 1968 |
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Current U.S.
Class: |
215/247;
215/DIG.3 |
Current CPC
Class: |
B65D
51/002 (20130101); Y10S 215/03 (20130101) |
Current International
Class: |
B65D
51/00 (20060101); B65d 041/20 () |
Field of
Search: |
;215/38,37,39,41,47,48,DIG.3 ;220/24.5 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Dixson, Jr.; William T.
Parent Case Text
This is a continuation-in-part application of my earlier filed
pending application, Ser. No. 801,914 filed Jan. 28, 1969 entitled
"A Stopper for Medicament Flasks" which was a continuation-in-part
application of my earlier-filed application, Ser. No. 697,749 filed
Jan. 15, 1968 entitled "Stopper for Medicament Flasks", now
abandoned.
Claims
I claim:
1. A stopper and cap member assembly adapted to be assembled to a
container so that the stopper overlies the opening in the
container, said stopper being of a resilient material and
consisting of an outer annular portion and a central section
connected by a wall portion, said cap member having a generally
cylindrical skirt portion having at one end an inwardly directed
annular disc-like top and means at its opposite end for securing
the cap member to the container, the disc-like top forming an
opening exposing the central section of the stopper, the outer
annular portion of the stopper being under compression between the
top of the cap and portion of the container adjacent the opening
therein, means defining an arcuate indentation in the central
portion of the stopper in the face thereof exposed through the
opening in the cap member, the apex of the indentation being
disposed below a plane through the inner surface of the wall
portion connecting the outer annular portion to the central
section.
2. The assembly as claimed in claim 1 wherein the indentation is
hemispherical and is disposed generally centrally thereof.
3. The assembly as claimed in claim 1 wherein the top wall is of
substantially uniform thickness.
4. The assembly as claimed in claim 1 wherein said indentation is
conical and the outer surface defining the conical indentation is
tapered at an angle of about 53.degree. to a perpendicular plane
through the apex.
5. The assembly as claimed in claim 4 wherein the inner conical
wall is disposed at an angle of about 37.degree. relative to a
surface of revolution through the juncture of the inner conical
wall and the inner radial wall.
6. The assembly as claimed in claim 1 including a plurality of
raised lugs on the surface of the top portion.
7. The assembly as claimed in claim 1 wherein there are four
indentations disposed in a circular array equi-spaced from one
another.
8. The assembly as claimed in claim 7 including means defining an
annular groove in the bottom face of said top wall circumscribing
said indentations and wherein the lower edge of said groove lies in
a plane closer to the outer face of the top wall than a plane
through the apex of said indentations.
9. The assembly as claimed in claim 1 including means defining an
annular recess in the lower face of the connecting wall portion of
the stopper between the outer annular portion and central section.
Description
The present invention relates to an improvement in stoppers for
medicament flasks made of a chemical-resisting elastic material,
and which are fastened to the neck of the flask by the aid of a
flanged cap.
There are known stoppers for medicament flasks, which stoppers are
made of chemical-resisting elastic material and are fastened to the
flask neck by annular flanged caps made of sheet metal. These
stoppers are made hollow inside, whereby the bottom surface of this
hollow has a convex bulge. Such medicament flasks are used for
filling hypodermic syringes. For this purpose the stopper is
pierced by the needle of the syringe and the syringe is then
filled. This arrangement, of course, obviates the need for removing
the stopper and ensures against contamination of the contents of
the container.
In the case of the known stoppers, difficulties are produced
through their being positioned into the flask neck and their being
fastened by means of a clamp-on flanged cap that compresses in the
region of where the needle is stuck in, this making difficult not
only the introduction of the needle, but on occasion also the
stopper becomes stressed in such a way that small portions of its
material may become sheared off, and even get into the hollow
needle. This is a serious problem in that it presents the
possibility of injecting the rubber core into a patient upon
discharge of the contents of the syringe.
The innovation has the fundamental problem of creating a stopper of
the kind mentioned at the outset but avoiding the drawbacks of the
known stopper. In accordance with the innovation this is achieved
in that the cup-shaped stopper is provided at its end wall with a
bulge directed toward the flask interior. This bulge is preferably
made hemispherical. With the form of stopper according to the
innovation, when a hollow needle is introduced, tension stresses
are chiefly produced in the stopper end wall, through which the
needle can be introduced without any material use of force. In
accordance with embodiment of the present invention, the apex of
the indentation in the top face of the stopper is preferably
located in a plane below the lower face of the stopper immediately
surrounding the indentation. By this configuration, when the needle
penetrates the stopper in the indentation, a conical pocket is
formed of a size to permit the needle to penetrate without being
caught by the heel. It has been found that this particular
arrangement substantially eliminates the possibility of
"coring".
The innovation is described in more detail in the following by the
aid of the drawings showing one example of construction. In the
drawings;
FIG. 1 is a plan view of a stopper according to the innovation;
FIG. 2 is a longitudinal section through a medicament flask with
the stopper;
FIG. 3 is a top plan view of a second embodiment of stopper and cap
assembly;
FIG. 4 is an enlarged sectional view taken on lines 4--4 of FIG.
3;
FIG. 5 is a perspective view of the second embodiment of stopper in
accordance with the present invention;
FIGS. 6, 7 and 8 are sectional views similar to FIG. 4 showing a
hypodermic needle at various stages of penetration in the
stopper;
FIGS. 9, 10 and 11 are sectional views of a conventional stopper
showing various stages of penetration of a hypodermic needle;
FIG. 12 is a longitudinal sectional view of third embodiment of
stopper and cap assembly constructed in accordance with the present
invention;
FIG. 13 is a view similar to FIG. 12 showing a hypodermic needle in
partially penetrating position and fully penetrated position;
FIG. 14 is a top plan view of the stopper and cap assembly; and
FIG. 15 is an inverted plan view taken on lines 15--15 of FIG.
12.
Referring now to the drawings and particularly to FIGS. 1 and 2
thereof, there is illustrated a stopper and cap assembly for
mounting over the open end of a container or flask 10 having a neck
10a provided at its inner end with an annular ridge 10b. The
stopper 11 is preferably made of a chemical-resisting elastic
material such as rubber or of a synthetic material and, as
illustrated, is cup-shaped.
This stopper is inserted by its cylindrical extension or skirt 11c
into the flask neck, and it is fastened on the ridge 10b of the
flask neck 10a by the aid of a flanged cap 12, which is made in the
form of a ring and which leaves most of the end face of the stopper
exposed, so that this end wall 11a can be pierced by a hollow
needle stuck through it.
The end wall 11a of the stopper 11 is provided in its middle with a
bulge 11b directed toward the flask interior, and which is
preferably made spherical or hemispherical. The wall thickness of
the stopper is preferably substantially uniform. The hollow needle
is introduced into this bulge for the purpose of filling a
hypodermic syringe. The bulge 11b hereby becomes expanded inwardly,
through which stresses that are chiefly tensile become produced,
through which the introduction of the needle becomes greatly
facilitated. This also prevents that, because of great compression
stressing, fragments of the material of the stopper 11 might get
into the hollow needle. When the needle is pulled out, compression
stresses are on the contrary produced in the bulge 11b, through
which the material bears tightly against the needle, so that even
during the withdrawing of the needle perfect sealing is
ensured.
Another embodiment of stopper in accordance with the present
invention is illustrated in FIGS. 3-8. This embodiment of the
invention is aimed at eliminating the problem of "coring". It has
been found that in conventional stoppers, upon insertion of the
hypodermic needle through the contents of the container, a small
plug of rubber is cut away and trapped in the needle and this
phenomenon is referred to as "coring". This is a very serious
problem since there is the danger of injecting the core of rubber
into a patient upon discharge of the contents of the syringe and in
some instances, the rubber cores had deleterious effects upon the
patient. More specifically, the point of a hypodermic needle is cut
on a bias and as the point penetrates the rubber stopper, the core
is cut from the top surface of the stopper by the heel of the
needle. With reference to FIGS. 9-11 which show a conventional
stopper, it may be observed that the stopper is held firmly against
the lip of a container by an aluminum outer cap crimped under
pressure to the lip of the container. The compression on the rim of
the stopper creates forces acting toward the center, the only place
where the rubber is not firmly confined. Under these circumstances,
as the point of the needle advances into the rubber, the cut
produced by the point elongates into an arc producing a trap door
hinge at one side. The force created by the compression on the
rubber rim pushes this rubber flap into the only space available;
that is, the slanted side opening in the needle (see FIGS. 10 and
11). More specifically, since the underside of the piercing
diaphragm is a perfect arch in shape with both legs of the arch
retained by the bottle wall, there is no possibility of relief for
the compression forces developed and, therefore, the rubber flap
must intrude into the needle opening.
The embodiment of the invention illustrated in FIGS. 3-8
substantially eliminates the problem of "coring". The stopper as
illustrated comprises a disc-like top portion 50 having a depending
cylindrical skirt 52 adapted to engage in the opening 54 in the
neck 56 of the container 58. The top portion as illustrated has an
enlarged outer annular wall section 60 adapted to seat between the
rim 62 of the container and the top wall 64 of an outer cap 66
which holds the stopper in place. The central portion of the
stopper disposed interiorly of the skirt 52 consists of an annular
radial wall section 68 of smaller cross section than the outer wall
section 60 and a depending central section 70 defining a conical
indentation 72 in the outer surface of the top portion. The outer
surface defining the conical indentation is preferably tapered at
an angle A of about 53.degree. to a perpendicular plane P through
the apex 73 of the indentation 72. Further, the interior conical
wall 76 preferably is disposed at a sharper angle B of about
37.degree. to a surface of revolution R. Additionally, it has also
been found that an important feature in preventing "coring" is the
location of the apex 73 which is slightly radiused of the
indentation in a plane X below the plane through the lower surface
of the radial wall section 68. The stopper further includes in the
present instance four raised lugs 83 which are circumferentially
equi-spaced apart and project beyond the upper surface of the
annular wall section 60.
By this arrangement as the needle penetrates the stopper in the
area of the apex, the needle exerts its force from within the arch,
the sides of which are not supported by the bottle wall and are
thus free to be displaced in a direction to relieve the compressive
forces caused by the compression of the aluminum outer cap. In
effect, therefore, the penetration forms a pocket 91 which opens as
illustrated in FIG. 7 and is of a size to permit the needle to
penetrate without being caught by the heel. Thus, no core is cut
when the needle is inserted.
It is noted that the outer cap illustrated simply has an opening in
the center of the top to expose the stopper. Other forms of caps,
for example of the type having a removable central disk, may also
be employed with the stopper of the present invention.
There is illustrated in FIGS. 12-15 inclusive still another
embodiment of stopper and cap assembly in accordance with the
present invention. This form of the invention is particularly
suited for use in applications where it is necessary to pierce the
stopper at a plurality of locations and/or where the stopper may be
pierced by two needles simultaneously. For example, in some
instances the container may be packaged with a first substance to
which one or more substances are added to make the final
composition. An example of this would be preparation of plasma for
use in a transfusion. Additionally, in these instances the stopper
is pierced with a needle for a supply line to inject the blood into
the patient and the stopper is pierced at another location for a
line to permit ingress of air as the contents are being discharged.
In these applications it is essential to prevent "coring" in order
to preclude contamination of the solution. Moreover, it is also
important to have a self-sealing type stopper to eliminate leakage
problems when the container is inverted as is the case in blood
transfusions or the like.
The present invention provides a stopper and cap assembly which is
self-sealing after penetration by a hypodermic needle or the like
and which is characterized by novel features of construction to
preclude "coring".
To this end the assembly comprises a stopper 100 held over the open
end of a container 102 by means of an outer cap member 104 which
may be made, for example, of aluminum. The stopper 100 has, in the
present instance, a plurality of piercing areas or zones 106
adapted to be penetrated by a hypodermic needle N or the like to
gain access to the contents of the container for the purpose of
venting the same or adding another substance as described above.
The stopper as illustrated comprises a disc-like top portion 108
having a depending cylindrical skirt 110 adapted to engage in the
opening 112 in the neck of the container 102. The outer wall of the
skirt adjacent the lower edge is tapered as at 114 for ease of
assembly into the container. The skirt is spaced inwardly from the
outer terminal edge of the top portion 108 to define a shoulder 116
which seats on the rim of the container. The outer cap 104 has an
inwardly directed upper flange 118 which overlies the top portion
and an inwardly crimped shorter lower flange 120 engaging under the
finish on the bottle to securely hold the stopper in place. Note
that in the present instance the inner surface of the top within
the periphery of the skirt 110 lies in a plane above the plane of
the circumferentially extending shoulder 116.
In the present instance there are four circumferential equi-spaced
piercing zones 106 in the top face of the stopper which are
normally exposed through the circular opening defined by the inner
edge of the flange 118. Each of these piercing zones 106 is in the
form of a semi-circular indentation 122. In order to eliminate the
possibility of "coring" when the piercing zone or area is
penetrated by a hypodermic needle N, a circumferential groove 124
extending from the lower face of the top circumscribes each of the
indentations 122 and is of a sufficient depth so that the apex 126
of the indentations lies in a plane X below a plane Y through the
base of the groove 124. Additionally, as shown, the inner wall 130
defined by the groove 124 is downwardly convergent.
By this arrangement as the needle penetrates a piercing zone 106,
the penetration forms a pocket 132 as illustrated in FIG. 13 having
a conical configuration of a size to permit advance of the needle
without the heel engaging the side wall of the opening. In this
manner no core is cut when the needle is inserted.
* * * * *