Note: Descriptions are shown in the official language in which they were submitted.
CA 02262477 1999-02-22
. 1
MULTIPLE USE UNIVERSAL STOPPER
Field of the Invention
This invention relates to an elastomeric stopper having a self-sealing means
so that a
pharmaceutical fluid contained in a container closed by the elastomeric
stopper can be
repeatedly accessed by the use of a luer connector or a syringe having a blunt
or
sharp needle cannula.
Background of the invention
The prior art has developed numerous devices to prevent accidental needle
strike
injuries to practitioners and patients. Such injuries are known to spread
infectious
io diseases including hepatitis and AIDS. One of the main features of these
devices is
the lack of exposed sharp needles. The closures or stoppers have built in
access
means to the content of the containers, such as vials, cartridges and bottles.
The
closures or stoppers in these devices serve the dual function of hermetically
sealing
the container while allowing access to the content therethrough.
Stopper systems for containers such as vials and bottles are made of materials
that
are resistant to chemicals and pharmaceuticals such as corrosive materials,
reagents,
parenteral solutions and solid formulations reconstitutable with a solvent
prior to use.
The most commonly used stopper/container system for such products has been
glass
or plastic bottles and vials equipped with stoppers made of elastomeric
materials. The
system provides for good hermetical seal, safe storage and easy access to the
content through the elastomeric stopper via the use of an infusion spike or a
syringe
when withdrawal of the content is desired. The elastomeric stopper used
generally
comprises an elastomeric base, such as natural or synthetic rubber and an
inert
coating covering at least some portions of the stopper. The coating used
includes
chlorobutyl rubber, polymeric fluorocarbon resins such as
polytetrafluoroethylene and
various thermoplastic films. The coating is intended to insulate the
elastomeric
stopper base from the contents of the container in order to prevent contact
and
possible chemical reactions therebetween.
Generally, the elastomeric stopper is of cylindrical shape and has a flange
head
portion overlying the open top end of the container. Integral with the head
portion is a
body portion which extends into the open end and seated in the neck portion of
the
container, the diameter of the body portion being somewhat larger than the
inside
CA 02262477 1999-02-22
2
diameter of the container so that a tight seal is created between the body
portion and
the wall of the container. The lower end of the body portion is beveled
towards the
central, longitudinal axis of the body portion to facilitate the insertion of
the body
portion into the container. The circular bottom surface that faces the
contents of the
container is substantially planar and is imperforate, having no recess
therein. The
head portion of the stopper is provided with a central recess extending
downwardly
from the top thereof a substantial distance into the body portion so that the
central
recess and the circular bottom surface define a diaphragm. The walls forming
the
recess are generally cylindrical but may be provided with one or more circular
1o protuberances extending inwardly to terminate just short of the center line
of the
stopper. The circular protuberances serve to press against and hold the needle
of a
syringe when the needle is inserted through the recess to penetrate the
diaphragm for
removal of the contents of the container. The elastomeric stopper is held in
position
by a metal ring or cap usually constructed of aluminum. The metal ring or cap
has a
removable centre opening for allowing insertion of the syringe needle into the
container.
Various stopper and access systems exist in the prior art to hold and remove
the
contents of containers which are illustrated hereunder.
An example of a stopper according to the state of the art is reported in
Figures 6 and
2o 6A of the present application.
U.S. Patent No. 5,429,256 pertains. to a drug withdrawal system for a vial.
The
withdrawal system comprises: a vial containing a medicament therein and closed
with
a rubber gasket; and an apparatus which snap fits on top of the vial. The
apparatus
comprises: a chassis and a cap which is attached to the cap by a living hinge.
The
chassis is cylindrical and has vertical grooves on the external sides to
facilitate
handling. The top of the chassis has a central opening. The chassis includes a
removable male luer lock adapter, having external threads thereon, including a
ferrule
structure the lower end of which has a hollow sharpened lance. The apparatus
is
used with a syringe having a female luer lock connector which snap fits with
the
3o removable male luer lock adapter including the ferrule. In use, the cap
cover is
opened, and a syringe is screwed onto the outer end of the adapter, then
tightened on
the adapter which moves the lance downward thereby establishing flow
CA 02262477 1999-02-22
3
communication with the content of the vial.
U.S. Patent No. 5,433,330 relates to a needleless access stopper used on
containers
with a cannula having a blunt, stopper penetrating tip. The stopper includes a
disc and
a plug extending from the disc into the container. Also included is a
diaphragm defined
by a target region in the upper face. Also included is a centrally located
piercing point
positioned to pre-slit the diaphragm. This stopper is not suitable for
syringe, cartridge
or IV tubing having a female luer connector. Moreover, after use, the pre-slit
disc
does not assure a complete seal of the contents of the container from the
environment
and it is not useful for multiple use.
io There is the need in this field of technique to provide a multiple use
stopper system
allowing repeatedly access to a medical fluid contained in a container and at
the same
time providing access means allowing the access to the container with various
conventional external access means, such as cartridge or iv tubing equipped
with a
female luer connector or a syringe having sharp or blunt needle cannula or
sharp and
blunt spikes.
Summary of the invention
The present invention provides a multiple use universal closure assembly
allowing
repeatedly access to a medical fluid contained in a container with various
external
access means available to healthcare professionals and emergency practitioners
and
sometimes to patients requiring self-injections, such as cartridge or iv
tubing equipped
with a female luer connector or a syringe having sharp or blunt needle cannula
or
sharp and blunt spikes.
According to one aspect, the present invention provides a multiple use
universal
closure assembly allowing access to a medical fluid contained in a container
comprising accessing (receiving) and sealing means designed for multiple use
so that
the medical fluid can be repeatedly accessed. After each withdrawal of the
desired
amount of the medical fluid, the sealing means self-seals itself thereby
preventing
contamination of the medical fluid by air-born particles, such as dust and
bacteria.
More in particularly, the multiple use universal closure assembly according to
the
invention comprises:
an elastomeric stopper comprising sealing means; and
receiving means for external accessing means.
CA 02262477 1999-02-22
4
The elastomeric stopper according to the invention having a head portion and a
skirt
portion is made of an elastomeric base, such as a natural or synthetic rubber
preferably having an inert, polymeric coating thereon covering at least the
medical
fluid contacting portions of the stopper. The coating may be of chlorobutyl
rubber,
polymeric fluorocarbon resins and thermoplastic films.
The elastomeric stopper is of cylindrical shape and has a flange head portion
overlying the open top end of the container. Integral with the head portion is
a skirt
portion which extends into the open end and seated in the neck portion of the
container, the diameter of the neck portion of the container being somewhat
larger
io than the inside diameter of the skirt portion so that a tight seal is
created between the
skirt portion and the wall of the container.
In the centre portion of the elastomeric stopper there is a cylindrical
opening extending
through the head and the skirt portions of the stopper. The cylindrical
opening through
the stopper body would expose the content of the container to the environment
allowing contamination therefrom. In accordance with the present invention,
the
cylindrical opening is closed by a sealing means, namely a rupturable sealing
membrane. The rupturable sealing membrane may be made separately from the
elastomeric stopper, positioned in the opening, and sealed into the
elastomeric
stopper using thermoplastic or other sealing means known in the art.
Preferably, the
2o elastomeric stopper and the sealing membrane are integral with each other
and
produced by blow molding or other suitable manufacturing techniques. The
sealing
membrane is preferably a protuberance residing in the top half of head portion
of the
elastomeric stopper and is resembling an M-shaped configuration comprising:
vertical
leg portions or cylindrical side wall; a top surface resembling a cup or U-
shaped
portion extending downwards and toward the bottom portion of the elastomeric
stopper, forming an M-shaped configuration when taken together with the
cylindrical
side walls. The rupturable sealing membrane is of thin, elastomeric material
preferably
having a slit in its centre portion which slit does not completely traverse
the centre
portion of the rupturable sealing membrane.
3o The M-shaped sealing membrane in the elastomeric stopper would collapse, or
at
least deform when penetrated by a luer connector, sharp or blunt syringe
cannula.
For preventing such occurrence a rigid, cylindrical housing or male element,
open at
CA 02262477 1999-02-22
both ends are provided to support the M-shaped sealing membrane and also
serving
as a receiving (accessing) means for an external access means. Such external
access means is preferably female access means, such as a female luer
connector.
Such external access means are threaded into the male connecting means thereby
5 rupturing the sealing membrane to establish fluid communication with the
content of
the container.
The multiple use universal closure assembly further comprises (3) a
cylindrical collar;
and further (4) a removable cap.
The cylindrical collar, preferably made of metal such as aluminum, is fastened
over
io the elastomeric stopper and the neck portion of the container to securely
hold the
elastomeric stopper in the open end of the container. The cylindrical collar
comprises
a central opening in its flat top portion to allow access to the cylindrical
opening in the
stopper and to the sealing membrane and receiving means (male element) located
in
the cylindrical opening.
The removable cap covers the flat top and rim portions of the cylindrical
collar and
comprises retaining ears which engage the cylindrical collar to maintain the
closure
assembly in aseptic condition.
According to another aspect, the present invention provides a multiple use
universal
closure assembly/container combination comprising:
2o a container;
a multiple use universal closure assembly according to the invention.
According to another further aspect, the present invention provides a method
for
repeatedly accessing a medical fluid contained in a container equipped with
the
multiple use universal closure assembly of the present invention comprising
the steps
of:
i) providing the multiple use universal closure assembly/container
combination of the present invention;
ii) removing the removable cap from the flat top and rim portions of the
cylindrical collar thereby exposing the sealing means and the receiving means
in the
cylindrical opening of the elastomeric stopper; and
iii) accessing the medical fluid contained in the container by an external
access means.
CA 02262477 1999-02-22
6
The present invention provides sealing and accessing means for containers such
as
bottles or vials made of glass or plastic containing medical fluids, such as x-
ray
contrast media and parenteral liquids. The access means of the closure
assembly of
the present invention provides for hermetic sealing, safe handling,
sterilization and
storing. The sealing means are designed for multiple use so that the medical
fluid can
be accessed repeatedly. After each withdrawal of the desired amount of the
medical
fluid, the sealing means self-seals itself thereby preventing contamination of
the
medical fluid by air-born particles, such as dust and bacteria. For
convenience the
invention will be described in combination with glass medicinal bottles. It is
to be
io understood, however, that the invention includes sealing and receiving
(accessing)
means for containers in general which comprise rigid or semi rigid access
ports and
are capable of receiving such sealing and access means.
The container is preferably made of glass, however, it can also be made of
polymeric
materials known in the art. The container has a neck portion terminating in an
open
end to receive the closure assembly which is inserted in the open end to seal
the
content therein and maintain it in sterile and aseptic condition
While the present invention provides access to medical fluids using various
external
access means, it is preferred that the access means comprise no "sharps", such
as in
sharp needle cannulas, in order to prevent accidental injuries and
transmittance of
contagious diseases, such as AIDS.
The external access means is preferably a syringe, cartridge or IV tubing
having a
female luer connector. However, other access means, such as a syringe having a
sharp or blunt needle cannula or a spike may also be used to rupture the
sealing
membrane of the closure assembly.
Brief description of the drawings
With reference to the annexed drawings, illustrating the invention:
FIG. 1A is a perspective view of a container, a stopper with the multiple use
receiving
(access) means, and a cap covering the access means;
FIG. 1 B is a perspective view of the container and the stopper with the
multiple use
3o receiving means shown in FIG. 1A without the cap;
FIG. 2 is a top plan view of the container and the cap shown in FIG. 1A;
FIG. 3 is a top plan view of the container, the stopper with the multiple use
receiving
CA 02262477 1999-02-22
7
means without the cap thereon shown in FIG. 1 B;
FIG. 4 is a cross-sectional view of the container, the stopper with the
multiple use
access means and the cap covering the receiving means taken along the line 4-4
of
FIG. 1A;
FIG. 4A is a greatly enlarged cross-sectional view of the top of the
container, the
stopper with the multiple use receiving means and cap shown in FIG. 4;
FIG. 4B is a greatly enlarged fragmentary cross-sectional view of the top of
the M-
shaped multiple use diaphragm shown in FIG. 4A;
FIG. 4C is a top plan view of the M-shaped multiple use diaphragm shown in
FIG. 4A;
io FIG. 5A is a bottom plan view of the cap removed from the container shown
in FIG.
1 A;
FIG. 5B is a sectional view of the of the cap removed from the container shown
in
FIG.5A;
FIG. 6 is a top plan view of a prior art stopper designed to be pierced by a
spike; .
FIG. 6A is a cross-section of the prior art stopper of FIG. 6;
FIG. 6B is a cross-section of the stopper of the present invention having a
cylindrical
protuberance in the centre thereof which constitutes the seal or diaphragm in
the
stopper penetrable by various external access means;
FIG. 7 is a top plan view of the multiple use receiving (access) means
housing;
2o FIG. 7A is a cross-section of the multiple use receiving means housing;
FIG. 8 is a cross-section of the stopper, the receiving means housing in the
stopper
and elastomeric seal or diaphragm supported by the housing;
FIG. 9 is the cross-sectional view of a stopper used in lyophilization having
the M-
shaped multiple use diaphragm therein;
FIG. 10 is a top plan view of the stopper used in lyophilization having the U-
shaped
multiple use diaphragm therein shown in cross-sectional view in FIG. 9;
FIG. 11 shows a cross-section of a female luer connector with screw threads;
FIG. 12 is a cross-section of a female luer connector which is to engage
receiving
means housing shown in FIGS. 7,7A and 8, wherein the female luer connector and
3o receiving means housing are shown prior to their engagement;
Fig. 12A is a cross-section of the female luer connector partially engaging
receiving
means housing and rupturing the elastomeric seal shown in Fig. 12;
CA 02262477 1999-02-22
8
FIG. 12B is a cross-sectional view of the female luer connector completely
engaging
receiving means housing; and
FIG. 13 is a cross-sectional view of the female luer connector disengaging
receiving
means housing.
Detailed description of the invention
Referring to FIGS. 1A, 1B, 2, 3, 4, and 4A, the container 10 having an open
end in
which the multiple use universal stopper is used comprises a neck portion 12,
a side
portion 14, and a bottom portion 16. In the open end of neck portion 12 is
located the
multiple use universal stopper held securely in place by cylindrical collar 70
having an
io open area 71 in its top centre portion, said open area being defined by the
circular rim
denoted by the numeral 74. Cylindrical collar further comprises a flat top
surface 75
defined by circular rims 74 and 76 and top rim portion 73. Cylindrical collar
70 is
crimped at its bottom rim 72 to neck portion 12 of the container. Flat top
surface 75 is
covered by a cylindrical, removable cap 18 which comprises a flat top portion
20, and
a side rim portion 22 which overlaps top rim portion 73 of cylindrical collar
70. FIG. 1 B
shows locking ears 50 constituting a part of the universal stopper which is
described
later in reference to other Figures as the description of the invention
proceeds.
Referring to FIGS. 1A, 1 B, 5A and 5B, removable cap 18 covers flat top
surface 75
and top rim portion 73 of cylindrical collar to maintain open area in top
centre portion
2o 71 of cylindrical collar and locking ears 50 in aseption condition during
storage.
Removable cap 18 comprises: side rim portion 22, flexible retaining ears 24,
and
retainer button 26. When in place, retaining ears 24 are slid under circular
rim 74 in
cylindrical collar 70 providing a tight seal between removable cap 18 and flat
top
surface 75 of cylindrical collar. Retainer button 26 together with retaining
ears 24 also
serve to limit expansion of the thin elastomeric membrane or seal during
sterilisation.
Referring to FIGS. 1A, 1B, 4, 4A, 6, 6A, 6B and 8, the open end of the
container 10 is
to receive an elastomeric stopper 60 having a top surface 63 and a bottom
surface 65
and comprises: a head 62 and a skirt 64 integral therewith. The head comprises
a
flange 66, extending laterally outwardly from skirt 64 and is designed to
cover the
transverse end surface of the container. The elastomeric stopper shown in
FIGS. 6
and 6A is conventionally used by the prior art. In the present invention, as
best seen
in FIGS. 4A and 8, the elastomeric stopper further comprises: a cylindrical
opening 68
CA 02262477 1999-02-22
9
in its centre portion defined by cylindrical walls denoted by the numerals 80
and 80';
bottom ring portion denoted by the numerals 82 and 82'; and funnel shaped
opening
83 extending downward from the bottom ring portion into the container defined
by
walls 84 and 84'. Projecting upward towards the top surface 63 of elastomeric
stopper
60 is a hollow, vertically-oriented, cylindrical protuberance 85 defined by
cylindrical
walls 86 and 86' and top surface 120. Top surface 120, along with cylindrical
walls 86
and 86', are designed to serve as the elastomeric seal in the elastomeric
stopper. The
cylindrical protuberance is preferably integral with the stopper body such as
produced
by blow molding technique or it may be produced separately and sealed into the
io central opening defined by walls 80 and 80' in the elastomeric stopper 60.
The vertically-oriented cylindrical protuberance is of thin, membrane-like
material
designed to be ruptured by an external force exerted on the protuberance by an
external access means, such as a luer connector. As best seen in FIGS. 4B and
4C
showing in cross-sectional and top plan views, the cylindrical protuberance is
an M-
shaped diaphragm wherein the numerals 86 and 86' denote the leg portions and
the
numeral 120 denotes the top surface resembling a cup shape. The lowest point
in the
top surface 120 is denoted by the numeral 121 which is the centre point in the
cup-
shaped portion. At the centre point 121 there is provided a slit 122 extending
from the
top surface or inside surface toward the bottom surface 125 of the cup-shaped
portion
of the M-shaped diaphragm. The slit, however, does not penetrate the bottom
surface
125. The thickness between the slit 122 and the intact bottom surface 125 is
typically
of form about 0.001 to about 2.0 mm. The unpenetrated portion of the membrane
denoting its thickness at the centre portion is denoted by the numeral 127 in
FIGS. 4B
and 4C. The unpenetrated membrane maintains the content of the container in
sealed
condition. In use, when this membrane is ruptured by an external access means,
such as a needle cannula, luer connector or spike, fluid communication is
established
between the content of the container and the external access means. Upon
disengaging the external access means for the multiple use universal stopper,
the
cup-shaped portion of the diaphragm reseals itself for the reason that the
membrane
is resilient and springs back to its original configuration. As a results the
container is
re-sealed until the fluid withdrawal process is repeated.
In reference to FIGS. 7, 7A and 8, in order to support vertically-oriented
cylindrical
CA 02262477 2007-05-07
protuberance 85 and to provide a means for receiving a male luer connector, a
cylindrical housing or male element (receiving means) generally designated as
100, is provided, located in the cylindrical opening 68 of elastomeric stopper
60.
Housing 100 comprises: cylindrical wall 102 having a top surface 104 and
bottom
5 surface 106. Cylindrical wall 102 comprises an inside wall 108, an outside
wall
110, locking ears 50, and horizontally-oriented bottom portion 112. Locking
ears
50 is designed to securely hold the female element of a luer connector.
Horizontally-oriented bottom portion 112 extends into the skirt 64 and sealed
thereto at the bottom ring portion 82 and 82' of elastomeric stopper 60.
10 The cylindrical protuberance serving as a sealing membrane is of inert gas-
impermeable polymeric material capable of flexing under internal or external
pressures such as exerted during steam sterilisation. Preferably the membrane
has a thickness of from about 0.001 mm to about 2.00 mm and a durometer of
from about 25 to about 80 Shore A. Suitable elastomeric materials for
constructing the membrane include:
natural rubber;
acrylate-butadiene rubber;
cis-polybutadiene;
chlorobutyl rubber;
chlorinated polyethylene elastomers;
polyalkylene oxide polymers;
ethylene vinyl acetate;
fluorosilicone rubbers;
hexafluoropropylene-vinylidene fluoride-tetrafluoroethylene
terpolymers, such as sold under the tradenames of Fluorel and Viton;
butyl rubbers;
polyisobutene, such as sold under the tradename Vistanex;
synthetic polyisoprene rubber;
silicone rubbers;
styrene-butadiene rubbers;
tetrafluoroethylene propylene copolymers; and
thermoplastic-copolyesters.
CA 02262477 1999-02-22
11
The cylindrical M-shaped protuberance is positioned in elastomeric stopper 60
so that
its top surface 120 is spaced about 2 to 3 mm form retainer button 26 of
removable
cap 18 when the cap is placed on container 10. The spacing allows the membrane
to
flex outwardly under pressure, such as created under heat sterilisation.
However,
spacing should not be more than about 2 to 3 mm so that under accidentally
high
pressures, bursting of the membrane is prevented by the retaining button 26 of
removable cap 18.
The multiple use universal closure assembly of the present invention may also
have a
configuration shown in FIGS. 9 and 10. The stopper of this configuration is
used
io when lyophilization of the content of the container is desired. Prior to
use the
lyophilized content is reconstituted by injecting into the container through
the multiple
use universal stopper water, saline or other liquids.
The universal closure assembly of the present invention is preferably used
with an
external female luer connector when fluid communication is desired with the
content of
the container stoppered by the universal stopper. A typical female luer
connector 140
is shown in FIG. 11 and comprises: cylindrical outside wall 142 and
cylindrical inside
wall 143 having an opening in their centre portion for accommodating a tubing
within
the inside wall. Cylindrical ring 144 located in the top centre portion of
cylindrical
inside wall 143 tightly holds tubing 160 which has a fluid communicating
channel 162.
Cylindrical inside wall 143 further comprises integral screw threads 146, 148,
150 and
152 which, upon connecting the female luer connector to the male luer
connector,
engages locking ears 50 on the housing or male element 100, as shown in FIGS.
7
and 7A. Other type of female luer connectors, such as snap-on connectors may
also
be used.
FIG. 12 shows, in cross-sectional view, a syringe having a female luer
connector,
which is to engage the multiple use universal stopper in the container 10,
wherein the
syringe and universal stopper are shown prior to their engagement. When it is
desired
to deliver medical fluid from container 10 to a patient, removable cap 18 is
removed by
an upward manual pressure exerted on its rim portion 22 thereby exposing
locking
3o ears 50 of the access means housing.
If the female luer connector of FIG. 11 is used, it is attached to the
multiple use
universal closure assembly by twisting motion wherein threads 146, 148, 150
and 152
CA 02262477 1999-02-22
12
engage locking ears 50 of access means housing 100. Upon turning the female
luer
connector 140, end portion of tubing 160 ruptures membrane of the universal
stopper
to establish fluid communication with the content of the container.
FIG. 12A shows, in cross-sectional view, the syringe having the female luer
connector
partially engaging the multiple use universal closure assembly.
FIG. 12B shows, in cross-sectional view, the syringe having the female luer
connector
completely engaging the multiple use universal closure assembly.
FIG. 13 shows, in cross-sectional view, the syringe having the female luer
connector
removed from the multiple use universal closure assembly after their
engagement.
1o The multiple use universal closure assembly can be engaged by an external
female
luer connector having a blunt end which engages and ruptures the cylindrical M-
shaped seal in the centre of the multiple use universal closure assembly.
However,
the multiple use universal stopper also allows access to the content of the
container
by a sharp or blunt needle cannula or a spike.
Materials of Construction and Use
The elastomeric stopper used in conjunction with the universal stopper of the
present
invention is fluid impervious, resilient, and inert without leachable
additives therein in
order to prevent any alteration of the product contained in the container. It
may be of
a single component or a blend of components. Examples of materials include
synthetic and natural rubbers, such as butyl rubber, isoprene rubber, silicone
rubber,
halogenated rubber, ethylene propylene therpolymer and the like. Specific
examples
of a synthetic elastomeric rubber include the CH2CF2 C3F6(C3F5H) and the C2F4
C2F3OCF3 series of elastomers made by DuPont under the trade names of VITON
and CARLEZ ; the fluoro-silicone rubbers, such as those made by Dow Corning
under the trade name of SILASTIC ; and polyisobutylenes, such as VISTANEX MML-
100 and MML-140; and halogenated butyl rubber, such as CHLOROBUTYL 1066,
made by Exxon Chemical Company.
These or other suitable elastomers may be made into the desired stopper
configuration by known methods. Such methods conventionally include the use of
a
curing agent, a stabilizer and a filler and comprise a primary and a secondary
curing
step at elevated temperatures.
The container used in conjunction with the present invention may be of glass
or a
CA 02262477 1999-02-22
13
polymeric material, i.e., plastic, which are well known in the pharmaceutical
industry.
When the container is made of glass, it is in the shape of a vial or bottle.
The vial or
bottle is of rigid or semi-flexible polymeric material. In all shapes the
container is
provided with a neck portion which is rigid and retains its configuration so
that it is
capable of being hermetically sealed by the elastomeric universal stopper of
the
present invention. The container may have a volume capacity of from 5 ml to
1000 ml
or more, preferably about 10 ml to 500 ml.
The mouth of the container is to receive the multiple use universal closure
assembly.
The external diameter of the stopper is slightly larger than the internal
diameter of the
1o neck of the container so that on insertion of the multiple use universal
stopper into the
mouth of the container, a tight, hermetic seal is achieved.
The cylindrical collar is preferably made of metal, such as aluminum, while
the
housing is made of hard plastic known by the prior art and used in conjunction
with
pharmaceutical fluids.
1s Prior to use, the container and component parts of the closure are
sterilised and the
container is filled with a pharmaceutical fluid, such as a parenteral
solution. The
multiple use universal stopper is inserted, hermetically sealing the content
of the
container. Cylindrical collar is then crimped onto the container to securely
hold the
multiple use universal closure assembly in the container. Lastly, the
removable cap is
20 snapped onto the cylindrical collar to complete the closing of the
container.
CA 02262477 1999-02-22
14
PARTS LIST
Container 10
Neck portion of container 12
Side portion of container 14
Bottom portion of container 16
Removable cap 18
Flat top portion of removable cap 20
Side rim portion of removable cap 22
Flexible retaining ears 24
Retainer button 26
Locking ears 50
Elastomeric stopper 60
Head of elastomeric stopper 62
Top surface of elastomeric stopper 63
Skirt of elastomeric stopper 64
Bottom surface of elastomeric stopper 65
Flange of elastomeric stopper 66
Elastomeric seal in prior art stopper 67
Cylindrical opening in elastomeric stopper 68
Cylindrical collar on container 70
Open area in top centre portion of cylindrical collar 71
Top rim portion of cylindrical collar 73
Open area in top centre portion of cylindrical rim 74
Flat top surface of cylindrical collar 75
Funnel-shaped opening in skirt of elastomeric stopper 83
Circular rims defining flat top surface of cylindrical collar 74, 76
Cylindrical walls defining the cylindrical opening in elastomeric stopper 80,
80'
Bottom ring portion in the opening of elastomeric stopper defined by 82, 82'
Funnel-shaped opening in skirt of elastomeric stopper 83
CA 02262477 1999-02-22
Walls of funnel-shaped opening 84, 84'
Cylindrical protuberance constituting the seal in elastomeric stopper 85
(sealing means)
Walls of cylindrical protuberance 86, 86'
Cylindrical housing or male element (receiving means) 100
Cylindrical wall of housing 102
Top surface of housing 104
Bottom surface of housing 106
Inside wall of housing 108
Outside wall of housing 110
Horizontally oriented bottom portion of housing 112
Inside surface membrane of M-shaped diaphragm 120
Centre of inside surface membrane of M-shaped diaphragm 121
Slit in cup-shaped portion of M-shaped diaphragm 122
Bottom surface of cup-shaped portion of M-shaped diaphragm 125
Thickness of unpenetrated membrane at centre portion 127
Female luer connector 140
Cylindrical outside wall of female luer connector 142
Cylindrical inside wall of female luer connector 143
Cylindrical ring of female luer connector 144
Integral screw threads in inside wall of female luer connector 146, 148,
150, 152
Tubing in female luer connector 160
Fluid communicating channel in tubing 162
The present invention has been described in connection with the preferred
embodiment shown in the drawings, however, various changes and modifications
will
be apparent to those skilled in the art.
