Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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LARGE VOLUME FLEXIBLE CONTAINER
DESCRIPTION
Technical Field
. The present invention relates, in general, to flexible containers and, more
specifically, to
large volume, three-dimensional flexible containers.
Background of the Invention
Containers used for the shipping, storing, and delivery of liquids, such as
therapeutic
fluids or fluids used in other medical applications, are often fabricated from
single-ply or multi-
ply polymeric materials. The materials are typically in sheet form. Two sheets
of these
materials are placed in overlapping relation, and the overlapping sheets are
bonded at their
peripheries to define a chamber or pouch for containing the fluids. These
types of bags are
typically referred to as two-dimensional flexible containers, flat bags, or
"pillow bags." United
States Patent No. 4,968,624 issued to Bacehowski et al. and commonly assigned
to the assignee
of the present application, Baxter International Inc. ("Bacehowski"),
discloses a large volume,
two-dimensional flexible container. These types of bags can reach volumes as
large as 600
liters.
While 600 liters is a significant volume for a flexible container, there has
been an ever
increasing need to provide flexible containers of even greater volumes. This
has lead to the
development of three-dimensional flexible containers, sometimes referred to as
"cubic bags."
In the design and use of three-dimensional flexible containers of such
volumes, certain
problems are encountered. The large volume of liquid held by the containers
exerts a hydraulic
force against seams of the container, which in an unsupported state, might be
sufficient to cause
failure of the container. Indeed, containers this large, when filled with
water or some other
liquid, can weigh over 3000 pounds. The forces associated with such liquid
volumes can cause
the container seams to fail or rupture, therefore causing leaks in the
container. The liquid held
by the container may not be a commodity solution but often a sterile, custom
formulated
solution. Accordingly, even a very small leak can be costly in that any seam
rupture
compromises sterility of the entire contents of the container. Also, a failure
of a container seam
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can cause literally hundreds of liters of liquid to escape from the container.
This is costly in
replacing the lost liquid contents of the container. Clean-up costs are also
encountered.
These large volume, three-dimensional flexible containers are not intended to
be free
standing, but rather, are designed to be supported by a rigid or semi-rigid
support container
commonly referred to as a box or tank. The box can be made of various
materials, commonly
stainless steel. The stainless steel material is naturally an optical
obstruction from seeing into
the box. Typically, an operator has to look down into the box from the top.
The box may have
an access door on a side wall to allow an operator to view the inside of the
box. The door,
however, is very small in size and cannot provide a full view of the flexible
container within the
box. The side walls may have a series of small sight openings to allow one
determine the level
of liquid in the container. Similarly, however, these small sight openings do
not allow a full
view of the container within the box.
By necessity, the box and flexible container will have some interaction. It is
desirable
for the filled flexible container to transfer the load and associated forces
from the contained
liquid to the box, so that minimal loads (preferably zero) are carried by the
flexible container
material, especially the container seams. It is also desirable that the
container seams be fully
supported to prevent container failures due to "creep," which refers to the
loss of seal integrity
due to low but continuous tensile forces.
Because of the size of the containers, it may be difficult to properly align
the container
within the box. While initially properly aligned, the flexible container may
shift becoming
misaligned during the container filling process. If rnisaligned, the container
can have unwanted
folds that do not properly expand when the bag is filled. Such container folds
caused from
misalignment can result in undue stress on the container seams leading to
container failure.
For example, as the container is filled with liquid, the container inflates
and conforms to
the surrounding box. Ideally, the container conforms as close to the inner
walls of the box as
possible although pleating of the container can occur. At the appropriate
time, the liquid is
drained from the container wherein the container collapses. If the container
is unsupported, it
will tend to collapse in horizontal pleats. The pleats can trap liquid within
the container thus
preventing the container from being fully drained. In some cases, once the
container is drained,
the container has served its purpose and is then discarded. In other cases,
the container may be
refilled as part of a larger process. In these instances, a horizontal
pleating of the container can
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restrict the desired realignment during the refilling process. This can result
in poor orientation
or loss of the effective volume of the container. It may also result in
insu~cient support of the
container. Thus, it is also desirable to vertically support the container
within the box to
optimize the draining and filling processes. Vertical support of the container
within the box is
particularly important when filling the container a second time.
U.S. Patent No. 5,988,422 is directed to a sachet for bio-pharmaceutical fluid
products.
While the sachet is a three-dimensional container, the container does not have
optimal angular
construction between sides of the container. This will impact how such a
container can be
supported in a surrounding box. Accordingly, optimal filling, draining, and re-
filling of the
container cannot be achieved.
Some large volume flexible containers often employ a rigid or semi-rigid tube
used in
the filling and draining of the container, often referred to as a "dip tube."
The dip tube is
attached to the top of the container and extends downward to the bottom
interior surface of the
container. The dip tube supports the center portion of the top panel of the
container during
draining much like a tent post. In this configuration, the dip tube creates
vertical pleats during
draining of the container, and also allows a refilling deployment for the
container.
The dip tube, however, has several disadvantages. First, the dip tube cannot
orient the
distal vertical surfaces of the container if the container foot print geometry
is more complex
than a circle. In addition, as the container is drained, the walls of the
container converge
towards the center essentially creating loads of compression on the non-
compliant dip tube.
These compressive forces can cause several problems. The dip tube itself can
buckle under
these forces. The seal between the dip tube and the top of the container can
be compromised.
A bottom portion of the dip tube can also rupture the bottom of the container.
Using a dip tube
structure also increases the cost the container system. In addition, dip tubes
are also often
accompanied by a container vent to allow incoming air to displace fluid
instead of collapsing
the container material. Finally, the dip tube also provides another potential
mode of
contamination ingress to the contents of the container. Thus, there remains a
need for a vertical
support system for the container within the box that addresses the needs of
draining and refilling
without the added complexity of dip tubes and vents.
These large volume containers are also typically equipped with one or more
ports
equipped with a port closure for accessing the fluid within the container. The
container may
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have the port in a bottom pari°l that opens into the container.
Oftentimes, the port closure
includes a tube having one end connected to the port. Because the container is
often used in
medical and biotechnical applications, the port closure must include means for
maintaining the
other free end of the tube free from contamination. In other words, the free
end of the tube must
be equipped with a sterile closure that prevents potential contaminants from
entering the tube
and container. It is also desirable, however, to allow air to enter the
container because it
facilitates manipulation of the container during handling and installation.
There are two common approaches for providing a sterile closure at the free
end of the
tube. First, the free end of the tube can be sealed shut. In this application,
the tubing must be
selected from a thermoplastic material such as PVC or polyethylene that
permits sealing of the
material. This material can be heat sealed or sealed using other sealing
energies such as radio
frequency or ultrasonics. Using a silicone tube is desirable in the
manufacturing process
applications where the container is used. For example, a pump can be connected
to the tubing
for long periods of time so that the fluid can be pumped from the container.
The silicone tubing
also has the ability to withstand high temperatures, especially when the end
of the tube is
sterilized using steam in place (S.LP.) methodologies. One problem that exists
in using a sealed
silicone tube, however, is that while providing a sterile closure, it does not
facilitate the free
passage of gases. Gas transfer (venting) is desirable to facilitate
manipulation of the container
during handling and installation. In addition, to access a container having a
sealed tube, an
operator must use a sharp implement such as a knife, blade or other cutting
utensil to open the
tube. This introduces an opportunity to contaminate the tube, and also poses a
risk of injury to
the operator.
The second approach for providing a sterile closure at the free end of the
tube is to use a
formed element such as an injection molded part or stainless steel coupling.
The tubing is fitted
to the part or coupling, and then the part or coupling is covered with another
mating injection
molded part or coupling. Similar to the sealed tube approach, such fittings
provide a sterile
closure but do not provide for gas transfer without loss of sterility. In
addition, using injected
molded parts or stainless steel couplings is costly.
The present invention is provided to solve these and other problems.
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Summar~of the Invention
The present invention relates to containers and, in particular, to large
volume, three-
dimensional flexible containers.
According to a first aspect of the invention, a container is provided having a
plurality of
panels joined together to form a sleeve. The panels each have an end edge that
cooperate to
define an imaginary plane at one end of the sleeve. The container fiu-ther has
an end panel
coiulected to the panels at the one end of the sleeve. The end panel has at
least one portion
extending beyond the imaginary plane. According to another aspect of the
invention, the panels
form a polygonal sleeve. The portion of the end panel extends outwardly from
the sleeve.
Alternatively, the portion could extend inwardly towards the sleeve.
According to a further aspect of the invention, a large volume flexible
container capable
of containing a fluid to be maintained under sterile conditions is provided.
The container has a
first panel, a second panel, a third panel, and a fourth panel connected
together to form a
generally .cubic structure. The first panel has a central segment adjacent an
end segment. The
central segment has a longitudinal edge and the end segment has a tapered edge
extending from
the longitudinal edge. An angle is defined between the longitudinal edge and
the tapered edge.
The angle is in the range from about 135.01 ° to about 138 °. in
a most preferred embodiment,
the angle is 136°. This angle is maintained when the panels of the
container 10 are welded
together.
. According to a further aspect of the invention, a support container, or box,
is provided . .
for supporting the three-dimensional flexible medical container filled with
fluid. The box has a
frame having a top portion and a bottom portion. The frame has a plurality of
sidewalls
connected together at their extremities forming a chamber therein. The frame
further has a floor
spaced from the bottom portion. The chamber is sized to receive the flexible
medical container
wherein a bottom wall of the container is supported by the floor and sidewalls
of the container
are supported by sidewalls of the frame. Each sidewall supports a generally
transparent panel,
preferably a polycarbonate panel, such as LexanTM.
According to another aspect of the invention, a hanger system is provided for
providing
vertical support of the container supported within the box. A support member
is connected to a
top portion of the box. A hanger is provided having a plurality of depending
members adapted
to be connected to an end panel of the container. The hanger is connected to
the support
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member. In a preferred embodiment, the hanger includes a first member and a
second member
connected together substantially at their respective midportions to form an x-
shaped member.
The depending members are pivotally connected to ends of the hanger members.
According to yet another aspect of the invention, a port closure for the
container is
provided. The port closure provides a means for providing a sterile and gas
permeable barrier
over the port. In one embodiment, the port closure has a communication member
having a first
end and a second end, the first end adapted to be in communication with the
container. A stop
member is inserted into the second end of the communication member wherein the
stop member
is made from a porous material. A cover member is provided and receives the
second end of
the communication member. The cover member is releasably secured to the
communication
member. In a.preferred embodiment, the communication member is a tube made
from a
thermoplastic material. The stop member is a plug. An elastic band is wrapped
about the pouch
and the communication member releasably securing the cover member to the
communication
member. A tamper evident feature can also be incorporated into the port
closure.
Other advantages and aspects of the present invention will become apparent
upon
reading the following description of the drawings and detailed description of
the invention.
Brief Description of the Drawings
FIG. 1 is a perspective view of a medical fluid container of the present
invention;
FIG. 2 is a perspective view of another medical fluid container of the present
invention
that is larger than the container shown in FIG. l;
FIG. 3 is a perspective view of another medical fluid container of the pxesent
invention
that is larger than the containers shown in FIGS. 1 and 2, and shown in a
vertical configuration;
FIG. 4 is a side elevation view of the container of FIG. 1;
FIG. 5 is a plan view of a panel of the container;
FIG. 6 is a plan view of a gusseted panel of the container;
FIG. 7 is a perspective view of an end panel of the container;
FIG. 8 is a perspective view of the container of the present invention in a
generally
folded configuration, a supporting box being shown in phantom lines;
FIG. 9 is a perspective view of the container of FIG. 8 filled with fluid
during a filling
process;
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FIG. 10 is a perspective view of a box used to support the container, the
container being
positioned in the box;
FIG. 11 is a front elevation view of a container of the present invention
supported in a
box and utilizing a container hanger system;
FIG. 12 is a side elevation view of the container of the present invention
supported in
the box utilizing the container hanger system;
FIG. 13 is a perspective view of the container hanger system of the present
invention;
FIG. 14 is a top view of the container in the box of FIG. 13 wherein the
container is
partially drained;
FIG. 15 is a schematic perspective view of an alternative embodiment of the
container
hanger system of the present invention;
FIG. 16 is a schematic perspective view of another alternative embodiment of
the
container system of the present invention;
FIGS. 17a-a are schematic views of a draining process of the container
supported by the
container hanger system;
FIG. 18 is a plan view of a port closure used with the container;
FIG. 19 is a plan view of the port closure of FIG. 18 in an alternative
configuration;
FIG. 20 is a perspective view of a port closure connected to a container;
FIG. 21 is a perspective view of a container having multiple ports with a port
closure
connected at one port and an alternative port closure connected at the other
port;
FIG. 22 is a plan view of the container positioned in the box, the container
being
partially filled;
FIG. 23 is a plan view of the container positioned in the box, the container
being
substantially filled;
FIG. 24 is a partial enlarged view of a corner portion of a container
positioned in a box;
FIG. 25 is a partial enlarged view of the container of the present invention
in the box;
FIG. 26 is schematic perspective view of an alternative embodiment of the
container
hanger system of the present invention; and
FIG. 27 is a schematic perspective view of an alternative embodiment of the
container
hanger system of the present invention.
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Detailed Description
While this invention is susceptible of embodiments in many different forms,
there is
shown in the drawings and will herein be described in detail a preferred
embodiment of the
invention with the understanding that the present disclosure is to be
considered as an
S exemplification of the principles of the invention and is not intended to
limit the broad aspect of
the invention to the embodiments illustrated.
Referring to the drawings, FIG. 1 shows a container made in accordance with
the present
invention generally referred to with the reference numeral 10. The container
10 is a three-
dimensional container capable of holding large amounts of fluid. The container
10 shown in
FIG. 1 holds approximately 200 liters of fluid. The container 10, however, can
be made in a
variety of sizes. For example, FIG. 2 shows a container 10 sized to hold
approximately 500
liters of fluid, and FIG. 3 shows a container 10 sized to hold approximately
1500 liters of fluid.
The container 10 has a unique configuration that reduces seam stress to the
container 10 caused
by hydraulic forces generated from the fluid held in the container 10.
As shown in FIG. 1, the container 10 is three-dimensional and generally has a
rectangular shape having six sides, or sometimes referred to as having four
sides and two ends.
The container 10 is generally formed from four panels: a first panel I2 or top
panel 12, a
second panel 14 or bottom panel 14, a first side gusseted panel 16 and a
second side gusseted
panel 18. These walls 12-18 form four panels of the container and end portions
of each wall
cooperate to form the remaining two panels of the three-dimensional container
10, a first
gusseted end panel 20 and a second gusseted end panel 22. The individual walls
will first be
described and then the connections between the walls will be described to show
the structure of
the container l0.
FIG. 5 shows a plan view of the first panel 12 or top panel 12. It is
understood that the
second panell4 or bottom panel 14 has a similar structure and will not be
individually
described. The top pane112 generally has a central segment 24, a first end
segment 26 and a
second end segment 28. A fold line FL represents an interface between the
central segment 24
and the end segments 26,28. The end segments 26,28 are folded and cooperate
with end
segments of the other panels to cooperatively form the end panels 20,22 as
will be described in
greater detail below.
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As further shown in FIG. 5, the top panel 12 has a first peripheral edge 30
and a second
peripheral edge 32. Each peripheral edge 30,32 has a longitudinal portion 34
at the central
segment 24 and a tapered portion 36 at the first end segment 26 and the second
end segment 28.
At each end segment 26,28, the tapered portions 36 converge toward one another
but do not
meet. Rather, the tapered portions 36 meet an end edge 38. As will be
described in greater
detail below, the longitudinal portion 34 of the peripheral edge 30,32 meets
the tapered portion
36 at an angle A. Similarly, an angle B exists between the tapered portion 36
and the fold line
FL. Preferred measurements of the angles A and B will be described in greater
detail below that
optimize the seam strength of the container 10. The top panel 12 can include a
port 40 if
desired. The bottom panel 14 could also have a port 40. An additional port 41
could also be
provided (FIG. 1 ). It is understood that a port could be placed in any panel
of the container 10.
FIG. 6 discloses a plan view of the first side gusseted panel 16. It is
understood that the
second side gusseted panel 18 has similar structure and will not be separately
described. The
first side gusseted panel 16 also has a gusset central segment 42, a first
gusset end segment 44
and a second gusset end segment 46. A fold line FL represents an interface
between the gusset
central segment 42 and the gusset end segments 44,46. The gusset end segments
44,46 are
folded and cooperate with top and bottom panel 12,14 end segments 26,28 to
cooperatively
form the end panels 20,22 as will be described in greater detail below.
As further shown in FIG. 6, the gusseted panel 16 has a first peripheral edge
48 and a
second peripheral edge 50. Each peripheral edge 48,50 has a longitudinal
portion 52 at the
central segment 42 and a tapered portion 54 at the first gusset end segment 44
and the second
gusset end segment 46. At each gusset end segment 44,46, the tapered portions
54 converge
toward one another and meet at a point 56. As will be disclosed, the gusseted
panels 16,18 have
a gusset fold GF at generally a center-line of the panel. The panels 16,18
fold inwardly at the
gusset fold GF.
In constructing the container 10 into a three-dimensional form, the peripheral
edges of
the panels 12-18 are generally joined by suitable means known in the art, such
as heat energies,
RF energies, sonics or other sealing energies. The first and second gusseted
side panels 16,18
are positioned to space the top panel 12 and the bottom panel 14. The
peripheral edges of the
top panel 12 are sealed to respective peripheral edges of the gusseted side
panels 16,18 to form
seams. Similarly, the peripheral edges of the bottom panel 14 are sealed to
the opposite
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peripheral edges of the gusseted side panels 16,18. Specifically, for example,
the peripheral
edge 30 of the top panel 12 is sealed to the peripheral edge 48 of the first
gusset panel 16
wherein the respective longitudinal portions 34,52 are sealed together to form
a side seam 60
(FIG. 1), and the respective tapered portions 36,54 are sealed together to
form end panel seams
5 62. In this fashion, and as shown in FIG. 1, the flexible container 10 is
formed having a
generally three-dimensional rectangular shape. The central segments 24,42 of
the panels 12-18
form the sides of the container 10. The end segments 26,28 of the first and
second panels 12,14
and the end segments 44,46 of the gusseted side panels 16,18 cooperate to form
the gusseted
end panels 20,22. In this configuration, the end segments 26,28,44,46 serve as
connecting
10 members to form the end panels 20,22. The end segments converge towards one
another and
can be configured to join at a point, a line or a polygon. In a preferred
embodiment, the end
segments converge to a line. It is further understood that the container 10
can be configured
into any number of N-sided polygonal shapes. It is further understood that the
individual panels
could be comprised of a plurality of separate panels connected together to
form the panels of the
container 10. This may be done, for example, in making a container 10 even
larger than the
1500 L container shown in FIG. 3.
In a typical construction of a three-dimensional container, angle B would be
45 ° creating
the angle A (FIG. 5) between the longitudinal portion 34 and tapered portion
36 of the
peripheral edge 30,32 of 135 °. This would provide a construction such
that the end panels
20,22 would be generally perpendicular to the central segments 24,42 of the
panels 12-18. In
the container 10 of the present invention, the angle A is increased from 135
° to within a range
from about 135.01 ° to 138°. In a most preferred embodiment, the
angle A is about 136°. By
increasing this angle, more material is provided in the gusseted end panels
20,22. As shown in
FIG. 4, this extra material allows the end panels 20,22 to extend outwardly
from the central
segments 24,42 providing a "pent roof' (See FIGS. 2, 4 and 7). As further
shown in FIG. 4, the
panels 12-18, when connected together form a sleeve 64. In the preferred
embodiment, the
sleeve 64 is in the form of a rectangular parallelpiped shape. The panels each
have an end edge
63 that correspond to the end of the central segments 24,42 at the fold lines
FL. The end edges
63 define an imaginary plane P at the end of the sleeve 64. The end panel
20,22 has at least one
portion that extends beyond the imaginary plane P. In a most preferred
embodiment, the end
panel is contiguous with the sleeve and the entire end panel 20,22 extends
beyond the imaginary
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plane P. In this configuration, the end edges of the sleeve 64 are represented
by the fold lines
FL. With this extended configuration, when the container 10 is filled with
liquid, stresses on
the end panel seams 62 are reduced. This also prevents additional stresses
from being
transferred to other portions of the container 10.
FIGS. 8 and 9 disclose a filling process for the container 10 such as shown in
FIGS. 1
and 2, e.g. a container 10 in a horizontal configuration. For initial clarity,
the container 10 is
shown out of the supporting box (to be described) although it is understood
that the container 10
is filled with liquid after being positioned in the box. The container 10 is
positioned
horizontally with the bottom panel 14 against the base of the box. The
container 10 is flattened
wherein the first and second gusseted side panels 16,18 can be folded inward
to the container 10
although they are shown extended in FIG. 8. The gusseted end panels 20,22 are
folded over on
top of the top panel 12 when the container is in a supporting box. In this
configuration, the
container is easily filled. As shown FIG. 9, as the container 10 is filled,
the gusseted side panels
16,18 begin unfolding. Because each panel 16,18 has a single horizontal fold
GF, as opposed to
vertical gusset folds, there is less of a chance for the panels 16,18 to hang-
up against the box
and not fully unfold. If the panels 16,18 hang-up against the box, it prevents
the container 10
from being fully inflated, which can place undue stress on the container seams
during filling and
transportation of the container 10. FIG. 9 shows the container 10 partially
filled.
FIG. 2 discloses another container 10 that is designed to hold approximately
500 liters.
FIG. 3 discloses an even larger container 10 designed to hold approximately
1500 liters. In
containers 10 of the size shown in FIG. 3, it is sometimes desirable to
configure the container
such that gusseted end panels 20,22 are at the top and bottom of the container
10. Containers of
this configuration can be as much as 15 feet in height. This gives the
container 10 a smaller
footprint, which is desirable so it can be carried on a standard pallet. A
vertical footprint also
minimizes the floor space occupied by the container, which can be important in
storing a large
quantity of containers. The container 10 has a generally rectangular footprint
which provides a
greater overall volume than a generally cylindrical container of the same
height. It is
understood that in a container 10 having a vertical configuration (FIG. 3),
one of the end panels
20,22 may be referred to as a bottom panel such as end panel 20 shown in FIG.
3.
The container 10 of the present invention is not designed to be self
supporting, but is
rather supported by a supporting container 100 or rigid box 100. FIGS. 10-12
disclose the box
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100 that supports the container 10. The box 100 disclosed in FIGS. 10-12 is
designed to
support a container 10 in a vertical configuration such as shown in FIG. 3
although it is
understood that a box 100 can be configured to support a container 10 in a
horizontal
configuration. The box has an outer frame made up of a plurality of frame
members 102. The
frame members 102 are connected together to form a front wall 104, a rear wall
106 and two
sidewalls 108,110. The walls 104-110 are connected together to form a chamber
having a
generally square or rectangular cross-section. Each wall 104-110 has vertical
members 112 and
cross-members 114 to add rigidify to the walls. A bottom portion of the
vertical members 112
are adapted to rest on a supporting floor surface. The frame members 102 of
each wall 104-110
support a panel 113. In a most preferred embodiment, the panels are clear
polycarbonate panels
such as LexanTM panels. The frame members 102 of the walls 104-110 and the
panels 113
cooperate and are referred to as side panels of the box 100. The front wall
104 has a door 105
that is removably connected to the front wall 104. The door 105 allows access
to the inside of
the box 100 prior to filling the container 10 placed in the box 100. The box
110 further has a
bottom wall 116 that is positioned inward from the bottom portions of the
vertical members 112
so that the bottom wall 116 is slightly raised from the supporting floor
surface. The bottom
wall 116 has a first opening 118 and a second opening 120.. These openings
118,120 will
correspond to the ports 40,41 located on the container 10. The openings
118,120 help to
properly locate the container 10 within the box 100. The top portion of the
box 100 is open and
is designed to receive the flexible container 10. When the flexible container
10 is inserted into
the box 100, a discharge port and hose connected to the container (See e.g.,
FIG. 20) is fed
through the first opening 118. The container 10 will also have a second port
41, which may be
closed, that is inserted into the second opening 120 and assists in further
properly locating the
container 10 within the box 100. The container 10 is positioned such that the
bottom panel 20
of the container 10 is supported by the bottom wall 116 and the corners of the
bottom panel 20
of the container 10 are positioned substantially at the corners of the bottom
wall 116. The
container 10 is then connected to the hanger system to be described and then
is ready to be
filled.
FIGS. 10-17 disclose a hanger system 150 used in accordance with the present
invention. The hanger system 150 is utilized to support the empty upper
portion of the
container 10 to optimize filling and draining of the container 10. For
clarity, only a portion of
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the box 100 is shown in FIGS. 13, 15 and 16. The hanger system 150 generally
includes a
hanger 152, a support member 154, a cable 156 and a counterweight system 158.
As shown in FIG. 13, the hanger 150 has a first member 160 and a second member
162
connected together substantially at their respective midportions to form an x-
shaped member.
S The angles between the members 160,162 could vary as desired. In one
preferred embodiment,
an angle A is approximately 70° and an angle B is approximately
110°. The first member 160
has a first end 164 and a second end 166. The second member 162 has a first
end 168 and a
second end 170. The hanger 150 serves as a spreader member wherein the ends of
the members
160,162 spread out over the end panel or top panel 22 of the flexible
container 10. Each end
164-170 has a depending member 172 extending downwardly therefrom. In a
preferred
embodiment, the depending members 172 are pivotally connected to the first
member 160 and
second member 162. The pivotal connection provides benefits in the draining
process and the
filling process as will be described below. The depending members 172 each
have a protrusion
that is received in an eyelet 173 connected to the container 10 to hang the
container 10 from the
hanger 152. In a preferred embodiment, and as shown in FIG. 7, the eyelets 173
are located
along a diagonal seam between 35% and 65% of the length of the seam as
measured from an
outer corner C of the filled container 10. It is understood that the hanger
members 160,162 can
have different lengths to accommodate containers 10 of different sizes. The
hanger 152
provides a spider-shaped support configuration that spreads out the container
10 so that the
container 10 fills up with fluid with a minimum amount of pleating against the
LexanTM panels
113 of the side panels of the box 100. It is further understood that the
number of members and
depending members of the hanger 152 could vary depending on the size of the
container 10 and
the desired hanging configuration.
As shown in FIGS. 11 and 12, the support member 154 is generally an overhead
support
bracket 154. The support bracket 154 has a first post 174 and a second post
176 connected by a
cross rail 178. The first post 174 is connected to one side of the top portion
of the box 100 and
the second post 176 is connected to an opposite side of the top portion of the
box 100. Thus,
the cross-rail 178 spans over the open top portion of the box 100. In its
simplest form, the
container 10 is adapted to be hung from the hanger 152 by the cable 156 that
is connected
between the hanger 156 and the support member 154.
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The counterweight system 158 generally includes a first pulley 180, a second
pulley 182,
and a counterweight 184. The counterweight system 158 allows tension
adjustment to the upper
portion of the container 10. The first pulley 180 is connected to the cross
rail 178 and the
second pulley 182 is connected to a side of the box 100. The hanger system 150
is connected
such that a first end 186 ofthe cable 156 is connected to the hanger 152 and a
second end 188
of the cable 156 is connected to the counterweight 184. The counterweight 184
is suspended
outside and adjacent to the box 100. The cable 156 passes over the first
pulley 180 and the
second pulley 182. The hanger system 150 provides an upward biasing force to
the top portion
of the flexible container 10. By changing the weight of the counterweight 184,
tension on the
container 10 can be adjusted, in keeping with the volume of the container 10.
FIGS. 15 and 16 disclose alternative embodiments of hanger systems for the
container
10. FIG. 15 discloses a hanger system 200 having a hanger 202. The hanger 202
has a plurality
of cables 204 that depend from the hanger 202 and are connected to the
container 10. The
hanger 202 acts to spread the cables 204 to prevent tangling. The hanger
system 200 is hung
from the support member 154 and has a counterweight system 158. FIG. 16
discloses another
hanger system 210. The hanger system 210 has a first flexible member 212 and a
second
flexible member 214 connected together substantially at their respective
midportions. The ends
of the flexible members 212,214 are adapted to be connected to the container
10. The flexible
members 212,214 have a curved configuration. The hanger system 210 would be
hung from the
support member 154 and would also utilize the counterweight system i 58. When
the container
10 is initially hung, the members 212,214 bend towards a downward U-shape.
During the
filling of the container 10, the members 212,214 would straighten as the top
panel of the
container transitioned from a vertical co~guration to a horizontal
configuration. It is
understood that the hangers of the hanger system of the present invention
could be modified to
include a additional members such as to be employed with any N-sided polygon
foot print with
at least one connection per corner.
FIGS. 26 and 27 disclose additional alternative embodiments of hanger systems
for the
container 10. FIG. 26 discloses a spring assembly 400 that is mounted to a top
portion'of the
supporting box 100, shown schematically. The spring assembly 400 has a rod 402
having cords
404 extending from and connected to the rod 402. The rod 402 is rotatably
biased to wind the
cords on the rod 402. This provides an upward biasing force on the container
10. As shown in
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FIG. 27, two spring assemblies 400 can also be provided. It is further
understood that
additional spring assemblies 400 could be employed as desired.
It is further understood that hanger systems having different configurations
to provide an
upward biasing force on the container 10 are possible. For example, springs
could be employed
5 between the box 100 and container 10. Other elastic members could be
configured to apply an
upward force on the container. Another box could be utilized and connected to
the box 100 in a
coaxial fashion. A cylinder assembly could be connected between the two
coaxial boxes to
provide an upward biasing force or tension on an upper portion of the
container 10.
Once the container 10 is placed in the box 100 and hung using the hanger
system 150,
10 the container 10 can be filled. Fluid is pumped using, for example a
peristaltic pump (not
shown) that can be attached to a side portion of the box 100. The pump will
pump fluid through
the port hose attached to the port 40 on the bottom panel 20 of the container
10 (FIG. 3). The
hanging system 150 helps to suspend the container 10 uniformly within the box
100 such that
there is a minimum amount of pleating of the container 10 against the side
panels of the box
15 100. Also, the hanger system 150 permits full deployment of the bottom
panel 20 of the
container .10 along the contours of the bottom floor 116 of the box 100. As
the container 10
continues to be filled, the sidewalls of the container 10 deploy substantially
uniformly against
the side panels of the box 100. As the container 10 nears its full volume, the
pivoting
depending members 172 pivot as the top panel 22 of the container 10
transitions from a
generally vertical configuration to a substantially horizontal configuration.
Once filled, the container 10 is ready to be attached, for example, as part of
a subsequent
process. Such process may require the container 10 to be drained to deliver
the fluid to another
location for further processing. In this situation, the pump will pump fluid
from the container
10. As fluid is pumped from the container 10, the counterweight 184 maintains
an upwardly
biasing force on the container 10 to assist in the draining process. FIGS. 17a-
17e schematically
disclose a draining process of a flexible container 10 in the vertical
configuration being
vertically supported by the hanger system 150. As shown in FIGS. 17a-17c, the
flexible
container 10 pulls away from the box 100 as the container 10 is drained. The
container 10
begins collapsing at the outermost corners of the container 10 because of the
location of the
connecting points with the depending members 172. The resulting shape is
peaked with the
volume reduction of the emptying container 10 defined by inward peaked folding
pleats. As
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shown in FIGS. 17d and 17e, the defining shape is tent-like with the formation
of vertical
wrinkles 185. The vertical wrinkles 185 are defined between the hanger
connection points and
the draining level of the fluid within the container 10. Vertical wrinkles are
more desirable than
horizontal pleats as vertical wrinkles will allow greater deployment of the
container 10 within
the box 100 during a refilling process. As shown in FIG. 17e, as the fluid is
pumped out, and
with the corners of the bottom panel of the container 10 placed appropriately
at the corners of
the box 100, the bottom panel of the container 10 is sucked convex upward away
from the
intermediate floor of the box 100 by the evacuating action of the draining
pump. This defines
drainage points on the container 10 allowing fluid to run downwardly on this
surface to the port
40. As shown in FIG. 14, the depending members 172 pivot inwardly as the top
panel shifts
from a substantially horizontal configuration to a more vertical
configuration.
. During a refilling process, the pump pumps fluid back into the container
through the
same port 40 at the bottom panel 20 of the container 10. The convex upward
configuration of
the bottom panel 20 is re-contoured to the bottom floor 116 of the box 100 by
the weight of the
fluid. The fluid also then refills the lower corners of the bottom panel 20 at
the junction of the
vertical wrinkles 185 on the side panels of the container 10. During the
refilling of the
container 10, the vertical wrinkles 185 are once again defined by the level of
the fluid pushing
the material towards the corners of the box 100 and by the upward connection
of the hanger
152. Because of the configuration of the hanger 152 and its connection to the
top panel of the
container 10, the corners of the container 10, as the container 10 is filled,
tend to assist one
another in positioned themselves at the corners of the box 100. Because the
wrinkles 185 are in
a vertical configuration, the wrinkles 185 do not get trapped against the side
panels of the box
100 as a horizontal fold would get trapped. The vertical wrinkles 185 rather
open and deploy
against the side panels of the box 100.
~ The hanger system 150 provides several advantages. The hanger system 150
permits the
use of large volume flexible containers having a single port for use in
applications that require
filling, draining and then refilling without the additional expense and
hazards that may be
associated with flexible containers containing dip tube or vent design
features. The hanger
system 150 also permits complete collapse of the filled container 10 during
the draining process
without having to admit air into the container 10, thereby maintaining a
closed system. The
system 150 further provides support for refill deployment of the container 10
which minimizes
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undesirable pleating of the container 10. The system 150 forces the collapse
of the container
during draining to occur with predominately vertical wrinkles as opposed to
horizontal creases
that can prevent redeployment of the container 10 during refilling. This
vertical collapsing
configuration greatly improves the drainage performance of the container as
the bottom panel of
the container 10 is sucked convex upward defining lower drainage points on the
container 10.
FIGS. 22 and 23 disclose a further aspect of the invention. The flexible
container 10 is
sized to be larger than the box 100. In this configuration, the amount of
stress on the container
seams is minimized if the container 10, for example, does not become optimally
aligned within
the box wherein the four corners of the container are substantially adjacent
the four corners of
the box. FIG. 22 discloses a schematic plan view of the container 10 within
the box 100. The
container 10 is only partially filled with fluid. The panels of the container
are defined by a
container width CW and a container depth CD. The panels of the container 10
cooperate to
define a first perimeter Pl, i.e. P1 = 2 * (CW + CD). The side panels of the
box are defined by
a box width BW and a box depth BD. The panels of the box cooperate to define a
second
perimeter P2, i.e. P2 = 2 * (BW + BD). The panels of the container 10 are
sized such that the
first perimeter P 1 is larger than the second perimeter P2. This allows for
some "play" with
respect to the container 10 within the box 100 and will provide a certain
amount of wrinkles in
the container 10 preferably at the corners of the container 10 and box 100. In
a preferred
embodiment, the container 10 is sized with respect to the box 100 so that the
first perimeter P1
is about 2% to about 10% larger than the second perimeter P2 of the box 100.
As shown in
FIG. 23, when the container 10 is substantially filled with fluid within the
box 100, wrinkles are
formed in the container 10 at or near the corners. If the container 10 was
sized substantially
identically to the box 100, corners of the container 10 could pull away from
the corners as
shown in FIG. 24 thus putting more stress on the container 10. As shown in
FIG. 25, a larger
sized container 10 alleviates these potential problems wherein corners of the
container 10 are
optimally supported at corners of the box 100.
FIGS. 18-21 disclose a port closure 300 according to the present invention
designed to
provide a unique closure for the port 40 of the container 10. The port closure
300 provides both
a sterile and gas permeable barrier. The port closure 300 generally includes a
communication
member 302, a stop member 304, a cover member 306 and a band 308. The
communication
member 302 is typically in the form of a tube. The tube 302 is typically made
from an
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elastomeric material such as silicone. The size of the tube can vary depending
on the particular
application. In one preferred embodiment, a 3/4 in. tube is used. The tube 302
has a first end
and a second end, and the length of the tube is determined by the desired
application. The stop
member is typically in the form of a plug 304. The plug 304 is typically
cylindrical and selected
from material that is porous but has hydrophobic properties such that it
allows gases such as air
to pass through the plug 304 but prevents fluid from passing through the plug
304. In one
preferred embodiment, the plug 304 is made from a porous plastic material such
as
polyethylene. Polytetrafluouroethylene material could also be used. Other
materials are also
possible and materials can be used after being treated to possess hydrophobic
properties. The
pore size of the material is sized so that it is capable of providing a gas
permeable, sterile
barrier. In a most preferred embodiment, the plug is a commercially-available
Porex~
hydrophobic material. The plug 304 is generally about 1 inch in length and has
a diameter sized
such that it will form an interference fit when inserted into an end of the
tube 302. As further
shown in FIGS. 18-20, the cover member 306 has a first member 310 and a second
member
312. The members 310,312 can be made from cellophane or paper. In addition,
one member
can be paper and one member can be cellophane. As explained in greater detail
below, the
members 310,312 are sealed to one another to form a two-ply, peelable pouch
having an
opening to receive the second end of the tube 302. The band 308 is typically
also made from
elastic material such as silicone and can be cut from tube stock identical to
the tube used in the
port closure 300.
As further shown in FIG. 20, in constructing and connecting the port closure
300 to the
container 10, the tube 302 is first cut to the desired length, e.g. 6-30 feet
of tubing. A first end
314 of the tube 302 is inserted over the port 40 on the container 10 to form
an interference fit.
A cable tie 316 can be placed around the first end 314 of the tube 302 when
installed on the port
40 to more securely connect the tube 302 over the port 40. After tightening,
the cable tie 316 is
trimmed accordingly. The plug 304 is cut into a one inch length from the
desired plug stock.
As shown in FIGS. 18 and 19, the plug 304 is then inserted into a second end
318 of the tube
302. A portion of the plug 304 extends from the second end of the tube 302 to
allow the
operator to grasp the plug 304 on removal from the tube 302. The first and
second~members
310,312 of the cover 306 are sealed to one another but leaving one open end
320 (FIG. 20) to
form a pouch 322. The cover 306 is then placed over the second end 318 of the
tube 302 and
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plug 304. The band 308 is then placed around the cover 306 and the tube 302 to
secure the
cover 306 to the tube 302. Because the elastic band 308 is cut from tube stock
identical to the
tube 302, when the band 308 is placed around the tube 302, it provides a
radially compressive
force on the cover 306 against the tube 302. The cover 306 provides a
dustcover so that if the
second end 318 of the tube 302 is inadvertently dropped on the floor or
otherwise touch
contaminated, the porous plug 304 and tube end 318 remains clean and sterile.
If a tamper
evident feature is desired, the cover member 306 may be permanently affixed to
the second end
318 of the tube 302 with a non-removable accessory such as a shrink band 309
(FIG. 19). In
addition, as shown in FIG. 18, the cover 306 could be directly heat sealed to
the tube 302 thus
providing a tamper evident feature.
There are two general methods to access the plug 304 at the second end 318 of
the tube
302. As shown in FIG. 18, top edges 324 of the first and second members
310,312 can be
peeled apart to open the cover 306. Alternatively as shown in FIG. 19, the
band 308 can be
rolled down the tube 302 and the cover 306 pulled away~from the second end 318
of the tube
302. In either case, once the cover 306 is removed, the plug 304 can also be
removed wherein
the fluid can either be drained or pumped from the container 10.
In certain instances, a container may have a plurality of ports, e.g. a fill
port, a drain port
and a vent port. FIG. 21 discloses a container 10 having an additional port
330 closed by a vent
closure 332. The vent closure 332 is similar to the port closure 300 described
above. The vent
closure 332 has a short silicon tube 334 having one end connected to the
additional port 330. A
vent plug 336 made from the same material as the port closure plug 304 is
inserted into the free
end of the tube 334. The vent plug 336 allows gases to pass therethrough to
equalize pressure
inside the container 10 to the pressure outside the container 10. The vent
plug 336 enables
complete filling of the container 10 and attendant reduction of headspace
(i.e., the space of the
2~ fluid level and the top of the container). This is an advantage in a
stationary container
application because uncontrolled headspace can cause an alteration in the gas
concentrations in
the fluid, thus permitting a shift in the pH of the fluid. In a container 10
that is to be
transported, headspace is a particularly critical issue, because headspace
will allow sloshing of
the fluid during shipping. Such fluid movement can cause degradation of
proteins in the fluid
due to denaturation (foaming), a.s well as compromising the container itself
due to repeated
mechanical stresses (flex cracking).
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As further shown in FIG. 21, if desired, a valve 338 can be positioned within
the tube
334, or communication member, in between the first end and the second end. The
valve 338,
such as a stopcock valve or other suitable valve, can be open or closed to
allow or prevent
venting of the container 10 as desired. For example, the valve 338 can be
opened to vent the
5 container 10 during the later stages of filling. Conversely, the valve 338
can be closed such as
during shipping and draiiung.
The port closure 300 of the present invention provides numerous advantages,
namely
providing a sterile closure but still having gas-permeable properties. The
sterile barriter prevents
contamination. The permeable property of the closure 300 equalizes the
internal pressure
10 within the tube 302, and therefore the container 10 that is in
communication with the tube 302,
and the external pressure around the container 10. Pressure equalization
allows sterile air to
enter the container 10, which facilitates manipulation of the container 10
during handling and
installation. For example, pressure equalization allows the large, flexible,
collapsible container
10 to be easily manipulated while empty, without the risk of introducing non-
sterile air into the
15 container 10. It is essential to have air in the container 10 during
handling and installation,
because the air acts as a lubricant allowing the container panels to move
independently.
However, having air in the container 10 during sterilization and shipping
contributes to
container bulk. Container bulk is undesirable and attempted to be minimized to
the greatest
extent possible. Thus, it is desirable to be able to ship the container 10
filled with fluid but with
20 as little air as possible, and then to allow air to enter the container 10
without breaching sterility.
The sterile, gas permeable port closure provides these advantages. If the
second end 318 of the
tube 302 is accidently dropped or introduced to contaminants, the cover member
306 maintains
the second end 318 of the tube 302 and plug 304 sterile. In addition, the port
closure 300 does
not require injected molded ports or stainless steel couplings, thus providing
cost savings.
Furthermore, by using an interference fit between the tube 302 and plug 304,
no solvents are
needed to connect the plug 304 to the tube 302, therefore reducing the amount
of leachables into
the container 10.
It is understood that, given the above description of the embodiments of the
invention,
various modifications may be made by one skilled in the art. Such
modifications are intended
to be encompassed by the claims below.
