U.S. patent number 3,904,059 [Application Number 05/228,027] was granted by the patent office on 1975-09-09 for sterile closure for solution bottles.
This patent grant is currently assigned to Baxter Laboratories, Inc.. Invention is credited to David Bellamy, Jr., James L. Gould.
United States Patent |
3,904,059 |
Bellamy, Jr. , et
al. |
September 9, 1975 |
Sterile closure for solution bottles
Abstract
An improved closure for a parenteral solution bottle or the like
is disclosed. The closure is of the type having a resilient plug
mounted in the bottle neck and a cap anchored to the bottle neck
and overlying the periphery of the disc. The cap retains a rigid,
malleable disc in position overlying the plug. In accordance with
this invention, the rigid, malleable disc defines an annular ridge
facing and pressing against the plug to provide a pressure
seal.
Inventors: |
Bellamy, Jr.; David
(Kenilworth, IL), Gould; James L. (Springfield, IL) |
Assignee: |
Baxter Laboratories, Inc.
(Deerfield, IL)
|
Family
ID: |
22855443 |
Appl.
No.: |
05/228,027 |
Filed: |
February 22, 1972 |
Current U.S.
Class: |
215/247; 215/249;
215/349; 215/351; 215/DIG.3; 215/251 |
Current CPC
Class: |
B65D
51/002 (20130101); Y10S 215/03 (20130101) |
Current International
Class: |
B65D
51/00 (20060101); B65D 051/00 () |
Field of
Search: |
;215/37R,48,DIG.3,40,251,247,341,343,347,349,351,355,249
;220/39 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Price; William I.
Assistant Examiner: Marcus; Stephen
Attorney, Agent or Firm: Ellis; W. Garrettson Altman;
Louis
Claims
That which is claimed is:
1. In a closure for a parenteral solution container having a
resilient plug mounted in a container opening, and a rigid cap
assembly anchored to said container and overlying said plug, and
including a separate, rigid, malleable disc held in said cap
assembly in a position overlying and pressing against said plug to
provide a closed, sealed cap assembly, the improvement comprising a
rigid annular rib defined in said rigid disc and cooperating with
said plug to provide an annular, focused pressure seal whereby a
space exists between the portion of said rigid disc within the
annular rib and said plug for facilitating the sterilization of the
underside of said rigid disc and other surfaces defining said
space.
2. The closure of claim 1 which has a resilient disc interposed
between said rigid, malleable disc and said plug.
3. The closure of claim 1 in which said plug defines an annular
ridge for forming a second pressure seal.
4. In a closure for a parenteral solution container, a resilient
plug mounted in a container opening, said plug also having an
annular ridge adjacent its periphery, a resilient disc overlying
the outer end of the plug and annular ridge, a rigid, cup-shaped
assembly anchored to said container and overlying the periphery of
said disc, said cap assembly comprising a pair of nested,
cup-shaped members, each of the members defining a central aperture
overlying the resilient disc, a separate, rigid, malleable disc
carried by said cap assembly and occluding each central aperture
and overlying the resilient disc and plug, said rigid disc defining
a rigid annular rib facing and pressing against said resilient disc
and plug to provide a focused pressure seal by the pressure of said
annular rib against said resilient disc whereby a space exists
between the portion of said rigid disc within the annular rib and
said resilient disc for facilitating the sterilization of the
underside of said rigid disc and the upper side of said resilient
disc.
5. The closure of claim 4 in which said rigid, malleable disc is
interposed and held between the cup-shaped members.
6. The closure of claim 5 in which said annular rib of the rigid,
malleable disc is positioned within said annular ridge of the
plug.
7. The closure of claim 6 having passage means extending through
said plug and opening within said annular rib for communication
with the interior of the container.
Description
BACKGROUND OF THE INVENTION
It is of extreme importance for parenteral solution containers to
have a closure which maintains complete sterility on a long term
basis for the contents of the solution container, even under rough
handling, exposure to unclean environment, and the like.
One commercial closure system for intravenous solution bottles is
disclosed in Bauman U.S. Pat. No. 2,969,158, while a related system
is disclosed in Reimann U.S. Pat. No. 3,067,898.
Referring particularly to the above cited Baumann patent, which
represents a present commercial solution bottle closure, an
elastomeric plug having open passages extending therethrough is
mounted in a bottle neck. A resilient, latex disc overlies the
elastomeric plug, and is held in position by an inner cap which
grips the latex disc about its periphery. The inner cap has an
aperture adjacent the central portion of the latex disc. An
aluminum disc then overlies the inner cap, and is held in position
by an outer cap having a tear-away feature for opening.
Sterility is achieved by an annular ridge defined in the top
periphery of the rubber plug fitting in the bottle mouth. This
annular ridge presses against the underside of the latex disc to
provide a circular pressure seal, which assures the sterility of
the underside of the latex disc and the top portion of the rubber
plug within the annular ridge. However, although the aluminum disc
is dished to press gently against the latex disc, there is a
question in this prior art closure with respect to the sterility of
the upper side of the latex disc. Accordingly, certain precautions
should be taken upon opening this closure. For example, if the
outer cap and aluminum disc are removed, but one wishes to puncture
through the latex disc to gain entry to the contents of the
container, it is desirable to swab the top of the latex disc with
alcohol to prevent any traces of contamination entering the
solution.
Furthermore, in order to obtain a reliable seal between the latex
disc and the top of the rubber stopper, the flange which is part of
the inner cap and overlies the latex disc must be undesirably large
in order to assure a sterile pressure seal. This in turn interferes
with the opening of the container in the instance when the operator
removes the latex disc by pulling it laterally through a notch in
the inner cap. Because of the above construction, the pulling force
required to remove the latex disc is often undesirably high.
The invention of this application provides improved solutions to
the above problems. The closure of this invention can be used to
create a sterile field not only on the bottom of the resilient
latex disc of the type described above, but also on the top of the
central portion of the latex disc. This permits puncturing through
the latex disc without fear of contamination.
Furthermore, the flange of the inner cap holding the latex disc in
place can, in the closure of this invention, be narrower than in
the prior art because of the presence of additional means for
forming a pressure seal against the latex disc, which additional
means can be removed prior to pulling the latex disc free from
under the inner cap. Accordingly, the pulling of the latex disc
free can be effected with less effort.
Another commercial closure system utilizes an annular ridge defined
on the outer surface of a molded elastomeric plug in a container
mouth, and a flat, rigid, aluminum disc pressed against the annular
ridge with a high pressure seal by a cap attached to the container
mouth. A sterile area results between the plug and disc within the
annular ridge.
However, any small nick or other defect in the annular ridge of the
plug of this prior art structure may serve to permit the entry of
contamination under the aluminum disc.
A molded elastomeric plug has a substantial likelihood of receiving
a nick during handling. Also, molded articles are manufactured
relatively slowly and generally in a commercial operation many
dozens or hundreds of molds are used, each of which must be
individually inspected with care for defects at frequent
intervals.
In the invention of this application this disadvantage is avoided
by the use of an annular seal produced by an annular rib on a
rigid, malleable disc, which can be stamped to shape very rapidly
on a mass production basis with a single stamping die, and which,
being made of rigid metal or the like rather than elastomer, is
less likely to suffer accidental nicks or dents which might
endanger the sterile seal. Thus a simple inspection of a single
metal disc for defects on a periodic basis can reliably show that
all of the metal discs previously produced by the die are free of
defect.
DESCRIPTION OF THE INVENTION
In accordance with this invention, the previously known closure
systems are improved by forming in the rigid, malleable disc an
annular rib pressing against the resilient (e.g., latex) disc or
the plug directly to provide an annular pressure seal band by the
focused pressure of the annular rib against the elastic plug in the
bottle mouth, which pressure seal provides a sterilizable sealed
area defined between the central portions of the facing sides of
the resilient disc or plug and the rigid, malleable disc. This
creates a more reliable sterile field in the closure. As a result
of this, additional safety is provided to the user of the
parenteral solutions. A sterile space results between the resilient
disc or plug and the rigid disc portion within the annular rib for
improved sterilization of the surfaces surrounding the space.
In the drawings, FIG. 1 is a top plan view of a parenteral solution
bottle equipped with one embodiment of the closure of this
invention.
FIG. 2 is a view similar to FIG. 1, but with the outer portion of
the closure removed.
FIG. 3 is a vertical fragmentary sectional view taken along line
3--3 of FIG. 1, showing the improved closure mounted on a bottle
mouth.
FIG. 4 is an exploded perspective view of the individual parts of
the closure shown in the previous views.
In the drawings, closure 10 includes resilient plug 12 having a
pair of passages 14, 16 extending therethrough for communication
with the interior of the bottle 18. Plug 12 has an annular flange
20 adjacent its outer edge for overlying the mouth of bottle 18,
and an annular ridge 22 on its outer face disposed about passages
14, 16 for the purpose of providing a pressure seal against the
under surface of resilient disc 24, which is typically made of
latex.
Plug 12 can have a pair of notched out portions 13 which serve to
orient the stopper 12 for the automated emplacement of air tube
15.
Plug 12 and resilient disc 24 are secured to the mouth of bottle 18
by an inner cap 26 which is one of a pair of nested, cup-shaped
members comprising a cap assembly as part of said closure member.
Inner cap 26 is bent around annular bead 28 of bottle 18 for
securance to the bottle mouth, and defines an annular flange 30
which presses latex disc 24 against ridge 22 to provide a sterile
pressure seal about the underside of disc 24. Flange 30 defines a
central aperture 32 (FIG. 4) in inner cap 26 which is adjacent the
central portion of resilient disc 24.
Inner cap 26 has a cutaway portion 34 in flange 30 and a portion of
the side wall of inner cap 26 to provide a site for manually
gripping resilient disc 24 and pulling it away from its position
overlying plug 12 without removing cap 26. Because of the
improvements of this invention, flange 30 can be made of reduced
width without endangering the sterile field, which makes it easier
to pull resilient disc 24 laterally out of its position.
Outer cap 36 constitutes the second cup-shaped member of the cap
assembly, and overlies inner cap 26. Outer cap 36 is also bent
about head 28 for securance to the bottle mouth. Cap 36 also
defines an annular flange 38 which presses against the periphery of
rigid, malleable disc 40, to press disc 40 with substantial
pressure against resilient disc 24 and plug 12. Rigid disc 40 is
held in place between the flanges of inner cap 26 and outer cap 36,
and defines an annular rib 42 which is typically positioned inside
of integral circular ridge 22 of plug 12, and presses with high
pressure against resilient disc 24 and plug 20 to provide a
circular pressure seal which serves as an added barrier to
contamination after sterilization of the closure. Outer cap 36 is
generally pressed on the bottle 18 with a force of 200 to 280
p.s.i. for a closure about 25 to 30 mm. in diameter, and
accordingly, the circular pressure area created by annular rib 42
focuses or concentrates the force to provide a high pressure seal
having initial pressure substantially in excess of the above stated
figure. Likewise, rib 42 results in the creation of space 44, which
facilitates the sterilization of the underside of rigid disc 40 and
the upper side of resilient disc 24 in their central portions.
The portion 43 of disc 40 within rib 42 is typically coplanar with
the portion 45 of disc 40 outside of rib 42, but may be dome shaped
to contact tab 48 of cap 36 and thus maintain tab 48 in an exposed
and accessible position.
Outer cap 36 has an aperture 46 generally defined by flange 38. The
two apertures 32 and 46 are occluded by rigid malleable disc 40,
which is typically made of a metal such as aluminum. By the term
"malleable" it is meant that the disc can be readily stamped to
form rib 42, which is the case when disc 40 is made of aluminum,
steel, or an appropriate metal alloy.
Aperture 46 is occupied by opening tab 48, which is connected by
neck 50 to lines of weakness 52 for tearing outer cap 36 open in
the conventional manner.
The closure of this invention is opened in the conventional manner
of prior art closures by tearing off outer cap 36, removing disc
40, and then optionally grasping resilient disc 24 and pulling it
through notch 34 to expose apertures 14, 16 in plug 12.
The invention of this application typically provides a closure
member having an added sterile field on the top of resilient disc
24, as well as a second sterile field along the bottom thereof,
which provides an added margin of safety during use. For example,
it becomes unnecessary to swab resilient disc 24 with alcohol if
one desires to puncture through it to gain access to the solution
in the bottle, and there is less risk of a trace of contamination
being left behind as resilient disc 24 is pulled laterally through
notch 34.
Furthermore, the use of a rigid disc 40 having pressure rib 42 can
optionally give a more reliable sterile seal than has been
previously known when the disclosed double seal configuration is
used, as well as providing a reduced likelihood of failure of the
seal because of the use of rigid disc 40. In particular, rib 42
provides more reliable sealing in the region in notch 34 where the
seal between resilient disc 24 and ridge 22 is maintained only by
disc 40.
Also, because of the added holding and sealing action of rib 42,
flange 30 of inner cap 26 can be made narrower in the closure of
this invention, which results in easier removal of resilient disc
24 through notch 34.
The above has been offered for illustrative purposes only, and is
not intended to limit the invention as described in the claims
below.
* * * * *