US20020131654A1 - Large volume flexible container - Google Patents

Abstract

A container (10) having a plurality of panels (12-18) joined together to form a sleeve (64). The panels (12-18) each have an end edge that cooperate to define an imaginary plane (P) at one end of the sleeve (64). The container (10) further has an end panel (20,22) connected to the panels (12-18) at the one end of the sleeve (64). The end panel (20,22) has at least one portion extending beyond the imaginary plane (P). The supporting box (100) is provided to support the container (10). A hanger system (150) is provided and is attached to the box (100). The hanger system (150) supports an upper portion of the container (10) within the box (100). The container (10) is also provided with a port closure (300) that provides both a sterile and gas permeable barrier.

Description

TECHNICAL FIELD
• The present invention relates, in general, to flexible containers and, more specifically, to large volume, three-dimensional flexible containers.[0001]
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.” U.S. Pat. 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.[0002]
• 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.”[0003]
• 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 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.[0004]
• 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.[0005]
• 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.[0006]
• 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 misaligned, 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.[0007]
• 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 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 insufficient 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.[0008]
• U.S. Pat. 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.[0009]
• 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.[0010]
• 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.[0011]
• 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 have the port in a bottom panel 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.[0012]
• 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.I.P.) 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.[0013]
• 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.[0014]
• The present invention is provided to solve these and other problems.[0015]
SUMMARY OF THE INVENTION
• The present invention relates to containers and, in particular, to large volume, three-dimensional flexible containers.[0016]
• 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 further has an end panel connected 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.[0017]
• 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[0018]container10 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 Lexan™.[0019]
• 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 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.[0020]
• 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.[0021]
• 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.[0022]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of a medical fluid container of the present invention;[0023]
• FIG. 2 is a perspective view of another medical fluid container of the present invention that is larger than the container shown in FIG. 1;[0024]
• FIG. 3 is a perspective view of another medical fluid container of the present invention that is larger than the containers shown in FIGS. 1 and 2, and shown in a vertical configuration;[0025]
• FIG. 4 is a side elevation view of the container of FIG. 1;[0026]
• FIG. 5 is a plan view of a panel of the container;[0027]
• FIG. 6 is a plan view of a gusseted panel of the container;[0028]
• FIG. 7 is a perspective view of an end panel of the container;[0029]
• 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;[0030]
• FIG. 9 is a perspective view of the container of FIG. 8 filled with fluid during a filling process;[0031]
• FIG. 10 is a perspective view of a box used to support the container, the container being positioned in the box;[0032]
• FIG. 11 is a front elevation view of a container of the present invention supported in a box and utilizing a container hanger system;[0033]
• FIG. 12 is a side elevation view of the container of the present invention supported in the box utilizing the container hanger system;[0034]
• FIG. 13 is a perspective view of the container hanger system of the present invention;[0035]
• FIG. 14 is a top view of the container in the box of FIG. 13 wherein the container is partially drained;[0036]
• FIG. 15 is a schematic perspective view of an alternative embodiment of the container hanger system of the present invention;[0037]
• FIG. 16 is a schematic perspective view of another alternative embodiment of the container system of the present invention;[0038]
• FIGS. 17[0039]a-eare 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;[0040]
• FIG. 19 is a plan view of the port closure of FIG. 18 in an alternative configuration;[0041]
• FIG. 20 is a perspective view of a port closure connected to a container;[0042]
• 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;[0043]
• FIG. 22 is a plan view of the container positioned in the box, the container being partially filled;[0044]
• FIG. 23 is a plan view of the container positioned in the box, the container being substantially filled;[0045]
• FIG. 24 is a partial enlarged view of a comer portion of a container positioned in a box;[0046]
• FIG. 25 is a partial enlarged view of the container of the present invention in the box;[0047]
• FIG. 26 is schematic perspective view of an alternative embodiment of the container hanger system of the present invention; and[0048]
• FIG. 27 is a schematic perspective view of an alternative embodiment of the container hanger system of the present invention.[0049]
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 exemplification of the principles of the invention and is not intended to limit the broad aspect of the invention to the embodiments illustrated.[0050]
• Referring to the drawings, FIG. 1 shows a container made in accordance with the present invention generally referred to with the[0051]reference numeral10. Thecontainer10 is a three-dimensional container capable of holding large amounts of fluid. Thecontainer10 shown in FIG. 1 holds approximately 200 liters of fluid. Thecontainer10, however, can be made in a variety of sizes. For example, FIG. 2 shows acontainer10 sized to hold approximately 500 liters of fluid, and FIG. 3 shows acontainer10 sized to hold approximately 1500 liters of fluid. Thecontainer10 has a unique configuration that reduces seam stress to thecontainer10 caused by hydraulic forces generated from the fluid held in thecontainer10.
• As shown in FIG. 1, the[0052]container10 is three-dimensional and generally has a rectangular shape having six sides, or sometimes referred to as having four sides and two ends.
• The[0053]container10 is generally formed from four panels: afirst panel12 ortop panel12, asecond panel14 orbottom panel14, a first sidegusseted panel16 and a second sidegusseted panel18. These walls12-18 form four panels of the container and end portions of each wall cooperate to form the remaining two panels of the three-dimensional container10, a firstgusseted end panel20 and a secondgusseted end panel22. The individual walls will first be described and then the connections between the walls will be described to show the structure of thecontainer10.
• FIG. 5 shows a plan view of the[0054]first panel12 ortop panel12. It is understood that thesecond panel14 orbottom panel14 has a similar structure and will not be individually described. Thetop panel12 generally has acentral segment24, afirst end segment26 and asecond end segment28. A fold line FL represents an interface between thecentral segment24 and theend segments26,28. Theend segments26,28 are folded and cooperate with end segments of the other panels to cooperatively form theend panels20,22 as will be described in greater detail below.
• As further shown in FIG. 5, the[0055]top panel12 has a firstperipheral edge30 and a secondperipheral edge32. Eachperipheral edge30,32 has alongitudinal portion34 at thecentral segment24 and a taperedportion36 at thefirst end segment26 and thesecond end segment28. At eachend segment26,28, thetapered portions36 converge toward one another but do not meet. Rather, thetapered portions36 meet anend edge38. As will be described in greater detail below, thelongitudinal portion34 of theperipheral edge30,32 meets the taperedportion36 at an angle A. Similarly, an angle B exists between the taperedportion36 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 thecontainer10. Thetop panel12 can include aport40 if desired. Thebottom panel14 could also have aport40. Anadditional port41 could also be provided (FIG. 1). It is understood that a port could be placed in any panel of thecontainer10.
• FIG. 6 discloses a plan view of the first side[0056]gusseted panel16. It is understood that the second sidegusseted panel18 has similar structure and will not be separately described. The first sidegusseted panel16 also has a gussetcentral segment42, a firstgusset end segment44 and a secondgusset end segment46. A fold line FL represents an interface between the gussetcentral segment42 and thegusset end segments44,46. Thegusset end segments44,46 are folded and cooperate with top andbottom panel12,14end segments26,28 to cooperatively form theend panels20,22 as will be described in greater detail below.
• As further shown in FIG. 6, the[0057]gusseted panel16 has a firstperipheral edge48 and a secondperipheral edge50. Eachperipheral edge48,50 has alongitudinal portion52 at thecentral segment42 and a taperedportion54 at the firstgusset end segment44 and the secondgusset end segment46. At eachgusset end segment44,46, thetapered portions54 converge toward one another and meet at apoint56. As will be disclosed, thegusseted panels16,18 have a gusset fold GF at generally a center-line of the panel. Thepanels16,18 fold inwardly at the gusset fold GF.
• In constructing the[0058]container10 into a three-dimensional form, the peripheral edges of the panels12-18 are generally joined by suitable means known in the art, such as heat energies, RF energies, sonics or other sealing energies. The first and secondgusseted side panels16,18 are positioned to space thetop panel12 and thebottom panel14. The peripheral edges of thetop panel12 are sealed to respective peripheral edges of thegusseted side panels16,18 to form seams. Similarly, the peripheral edges of thebottom panel14 are sealed to the opposite peripheral edges of thegusseted side panels16,18. Specifically, for example, theperipheral edge30 of thetop panel12 is sealed to theperipheral edge48 of thefirst gusset panel16 wherein the respectivelongitudinal portions34,52 are sealed together to form a side seam60 (FIG. 1), and the respectivetapered portions36,54 are sealed together to form end panel seams62. In this fashion, and as shown in FIG. 1, theflexible container10 is formed having a generally three-dimensional rectangular shape. Thecentral segments24,42 of the panels12-18 form the sides of thecontainer10. Theend segments26,28 of the first andsecond panels12,14 and theend segments44,46 of thegusseted side panels16,18 cooperate to form thegusseted end panels20,22. In this configuration, theend segments26,28,44,46 serve as connecting members to form theend panels20,22. 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 thecontainer10 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 thecontainer10. This may be done, for example, in making acontainer10 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[0059]longitudinal portion34 and taperedportion36 of theperipheral edge30,32 of 135°. This would provide a construction such that theend panels20,22 would be generally perpendicular to thecentral segments24,42 of the panels12-18. In thecontainer10 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 thegusseted end panels20,22. As shown in FIG. 4, this extra material allows theend panels20,22 to extend outwardly from thecentral segments24,42 providing a “pent roof” (See FIGS. 2, 4 and7). As further shown in FIG. 4, the panels12-18, when connected together form asleeve64. In the preferred embodiment, thesleeve64 is in the form of a rectangular parallelpiped shape. The panels each have anend edge63 that correspond to the end of thecentral segments24,42 at the fold lines FL. The end edges63 define an imaginary plane P at the end of thesleeve64. Theend panel20,22 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 theentire end panel20,22 extends beyond the imaginary plane P. In this configuration, the end edges of thesleeve64 are represented by the fold lines FL. With this extended configuration, when thecontainer10 is filled with liquid, stresses on the end panel seams62 are reduced. This also prevents additional stresses from being transferred to other portions of thecontainer10.
• FIGS. 8 and 9 disclose a filling process for the[0060]container10 such as shown in FIGS. 1 and 2, e.g. acontainer10 in a horizontal configuration. For initial clarity, thecontainer10 is shown out of the supporting box (to be described) although it is understood that thecontainer10 is filled with liquid after being positioned in the box. Thecontainer10 is positioned horizontally with thebottom panel14 against the base of the box. Thecontainer10 is flattened wherein the first and secondgusseted side panels16,18 can be folded inward to thecontainer10 although they are shown extended in FIG. 8. Thegusseted end panels20,22 are folded over on top of thetop panel12 when the container is in a supporting box. In this configuration, the container is easily filled. As shown FIG. 9, as thecontainer10 is filled, thegusseted side panels16,18 begin unfolding. Because eachpanel16,18 has a single horizontal fold GF, as opposed to vertical gusset folds, there is less of a chance for thepanels16,18 to hang-up against the box and not fully unfold. If thepanels16,18 hang-up against the box, it prevents thecontainer10 from being fully inflated, which can place undue stress on the container seams during filling and transportation of thecontainer10. FIG. 9 shows thecontainer10 partially filled.
• FIG. 2 discloses another[0061]container10 that is designed to hold approximately 500 liters. FIG. 3 discloses an evenlarger container10 designed to hold approximately 1500 liters. Incontainers10 of the size shown in FIG. 3, it is sometimes desirable to configure the container such thatgusseted end panels20,22 are at the top and bottom of thecontainer10. Containers of this configuration can be as much as 15 feet in height. This gives the container10 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. Thecontainer10 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 acontainer10 having a vertical configuration (FIG. 3), one of theend panels20,22 may be referred to as a bottom panel such asend panel20 shown in FIG. 3.
• The[0062]container10 of the present invention is not designed to be self-supporting, but is rather supported by a supportingcontainer100 orrigid box100. FIGS.10-12 disclose thebox100 that supports thecontainer10. Thebox100 disclosed in FIGS.10-12 is designed to support acontainer10 in a vertical configuration such as shown in FIG. 3 although it is understood that abox100 can be configured to support acontainer10 in a horizontal configuration. The box has an outer frame made up of a plurality of frame members102. The frame members102 are connected together to form afront wall104, arear wall106 and twosidewalls108,110. The walls104-110 are connected together to form a chamber having a generally square or rectangular cross-section. Each wall104-110 hasvertical members112 andcross-members114 to add rigidity to the walls. A bottom portion of thevertical members112 are adapted to rest on a supporting floor surface. The frame members102 of each wall104-110 support apanel113. In a most preferred embodiment, the panels are clear polycarbonate panels such as Lexan™ panels. The frame members102 of the walls104-110 and thepanels113 cooperate and are referred to as side panels of thebox100. Thefront wall104 has a door105 that is removably connected to thefront wall104. The door105 allows access to the inside of thebox100 prior to filling thecontainer10 placed in thebox100. Thebox110 further has abottom wall116 that is positioned inward from the bottom portions of thevertical members112 so that thebottom wall116 is slightly raised from the supporting floor surface. Thebottom wall116 has a first opening118 and a second opening120. These openings118,120 will correspond to theports40,41 located on thecontainer10. The openings118,120 help to properly locate thecontainer10 within thebox100. The top portion of thebox100 is open and is designed to receive theflexible container10. When theflexible container10 is inserted into thebox100, a discharge port and hose connected to the container (See e.g., FIG. 20) is fed through the first opening118. Thecontainer10 will also have asecond port41, which may be closed, that is inserted into the second opening120 and assists in further properly locating thecontainer10 within thebox100. Thecontainer10 is positioned such that thebottom panel20 of thecontainer10 is supported by thebottom wall116 and the corners of thebottom panel20 of thecontainer10 are positioned substantially at the corners of thebottom wall116. Thecontainer10 is then connected to the hanger system to be described and then is ready to be filled.
• FIGS.[0063]10-17 disclose ahanger system150 used in accordance with the present invention. Thehanger system150 is utilized to support the empty upper portion of thecontainer10 to optimize filling and draining of thecontainer10. For clarity, only a portion of thebox100 is shown in FIGS. 13, 15 and16. Thehanger system150 generally includes ahanger152, asupport member154, acable156 and acounterweight system158.
• As shown in FIG. 13, the[0064]hanger150 has afirst member160 and asecond member162 connected together substantially at their respective midportions to form an x-shaped member. The angles between themembers160,162 could vary as desired. In one preferred embodiment, an angle A is approximately 70° and an angle B is approximately 110°. Thefirst member160 has afirst end164 and asecond end166. Thesecond member162 has afirst end168 and a second end170. Thehanger150 serves as a spreader member wherein the ends of themembers160,162 spread out over the end panel ortop panel22 of theflexible container10. Each end164-170 has a dependingmember172 extending downwardly therefrom. In a preferred embodiment, the dependingmembers172 are pivotally connected to thefirst member160 andsecond member162. The pivotal connection provides benefits in the draining process and the filling process as will be described below. The dependingmembers172 each have a protrusion that is received in aneyelet173 connected to thecontainer10 to hang thecontainer10 from thehanger152. In a preferred embodiment, and as shown in FIG. 7, theeyelets173 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 filledcontainer10. It is understood that thehanger members160,162 can have different lengths to accommodatecontainers10 of different sizes. Thehanger152 provides a spider-shaped support configuration that spreads out thecontainer10 so that thecontainer10 fills up with fluid with a minimum amount of pleating against theLexan™ panels113 of the side panels of thebox100. It is further understood that the number of members and depending members of thehanger152 could vary depending on the size of thecontainer10 and the desired hanging configuration.
• As shown in FIGS. 11 and 12, the[0065]support member154 is generally anoverhead support bracket154. Thesupport bracket154 has afirst post174 and asecond post176 connected by across rail178. Thefirst post174 is connected to one side of the top portion of thebox100 and thesecond post176 is connected to an opposite side of the top portion of thebox100. Thus, the cross-rail178 spans over the open top portion of thebox100. In its simplest form, thecontainer10 is adapted to be hung from thehanger152 by thecable156 that is connected between thehanger156 and thesupport member154.
• The[0066]counterweight system158 generally includes afirst pulley180, asecond pulley182, and acounterweight184. Thecounterweight system158 allows tension adjustment to the upper portion of thecontainer10. Thefirst pulley180 is connected to thecross rail178 and thesecond pulley182 is connected to a side of thebox100. Thehanger system150 is connected such that a first end186 of thecable156 is connected to thehanger152 and asecond end188 of thecable156 is connected to thecounterweight184. Thecounterweight184 is suspended outside and adjacent to thebox100. Thecable156 passes over thefirst pulley180 and thesecond pulley182. Thehanger system150 provides an upward biasing force to the top portion of theflexible container10. By changing the weight of thecounterweight184, tension on thecontainer10 can be adjusted, in keeping with the volume of thecontainer10.
• FIGS. 15 and 16 disclose alternative embodiments of hanger systems for the[0067]container10. FIG. 15 discloses ahanger system200 having ahanger202. Thehanger202 has a plurality of cables204 that depend from thehanger202 and are connected to thecontainer10. Thehanger202 acts to spread the cables204 to prevent tangling. Thehanger system200 is hung from thesupport member154 and has acounterweight system158. FIG. 16 discloses anotherhanger system210. Thehanger system210 has a firstflexible member212 and a secondflexible member214 connected together substantially at their respective midportions. The ends of theflexible members212,214 are adapted to be connected to thecontainer10. Theflexible members212,214 have a curved configuration. Thehanger system210 would be hung from thesupport member154 and would also utilize thecounterweight system158. When thecontainer10 is initially hung, themembers212,214 bend towards a downward U-shape. During the filling of thecontainer10, themembers212,214 would straighten as the top panel of the container transitioned from a vertical configuration 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[0068]container10. FIG. 26 discloses aspring assembly400 that is mounted to a top portion of the supportingbox100, shown schematically. Thespring assembly400 has arod402 havingcords404 extending from and connected to therod402. Therod402 is rotatably biased to wind the cords on therod402. This provides an upward biasing force on thecontainer10. As shown in FIG. 27, twospring assemblies400 can also be provided. It is further understood thatadditional spring assemblies400 could be employed as desired.
• It is further understood that hanger systems having different configurations to provide an upward biasing force on the[0069]container10 are possible. For example, springs could be employed between thebox100 andcontainer10. Other elastic members could be configured to apply an upward force on the container. Another box could be utilized and connected to thebox100 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 thecontainer10.
• Once the[0070]container10 is placed in thebox100 and hung using thehanger system150, thecontainer10 can be filled. Fluid is pumped using, for example a peristaltic pump (not shown) that can be attached to a side portion of thebox100. The pump will pump fluid through the port hose attached to theport40 on thebottom panel20 of the container10 (FIG. 3). The hangingsystem150 helps to suspend thecontainer10 uniformly within thebox100 such that there is a minimum amount of pleating of thecontainer10 against the side panels of thebox100. Also, thehanger system150 permits full deployment of thebottom panel20 of thecontainer10 along the contours of thebottom floor116 of thebox100. As thecontainer10 continues to be filled, the sidewalls of thecontainer10 deploy substantially uniformly against the side panels of thebox100. As thecontainer10 nears its full volume, thepivoting depending members172 pivot as thetop panel22 of thecontainer10 transitions from a generally vertical configuration to a substantially horizontal configuration.
• Once filled, the[0071]container10 is ready to be attached, for example, as part of a subsequent process. Such process may require thecontainer10 to be drained to deliver the fluid to another location for further processing. In this situation, the pump will pump fluid from thecontainer10. As fluid is pumped from thecontainer10, thecounterweight184 maintains an upwardly biasing force on thecontainer10 to assist in the draining process. FIGS. 17a-17eschematically disclose a draining process of aflexible container10 in the vertical configuration being vertically supported by thehanger system150. As shown in FIGS. 17a-17c,theflexible container10 pulls away from thebox100 as thecontainer10 is drained. Thecontainer10 begins collapsing at the outermost comers of thecontainer10 because of the location of the connecting points with the dependingmembers172. The resulting shape is peaked with the volume reduction of the emptyingcontainer10 defined by inward peaked folding pleats. As shown in FIGS. 17dand17e,the defining shape is tent-like with the formation ofvertical wrinkles185. Thevertical wrinkles185 are defined between the hanger connection points and the draining level of the fluid within thecontainer10. Vertical wrinkles are more desirable than horizontal pleats as vertical wrinkles will allow greater deployment of thecontainer10 within thebox100 during a refilling process. As shown in FIG. 17e,as the fluid is pumped out, and with the comers of the bottom panel of thecontainer10 placed appropriately at the comers of thebox100, the bottom panel of thecontainer10 is sucked convex upward away from the intermediate floor of thebox100 by the evacuating action of the draining pump. This defines drainage points on thecontainer10 allowing fluid to run downwardly on this surface to theport40. As shown in FIG. 14, the dependingmembers172 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[0072]same port40 at thebottom panel20 of thecontainer10. The convex upward configuration of thebottom panel20 is re-contoured to thebottom floor116 of thebox100 by the weight of the fluid. The fluid also then refills the lower corners of thebottom panel20 at the junction of thevertical wrinkles185 on the side panels of thecontainer10. During the refilling of thecontainer10, thevertical wrinkles185 are once again defined by the level of the fluid pushing the material towards the comers of thebox100 and by the upward connection of thehanger152. Because of the configuration of thehanger152 and its connection to the top panel of thecontainer10, the corners of thecontainer10, as thecontainer10 is filled, tend to assist one another in positioned themselves at the comers of thebox100. Because thewrinkles185 are in a vertical configuration, thewrinkles185 do not get trapped against the side panels of thebox100 as a horizontal fold would get trapped. Thevertical wrinkles185 rather open and deploy against the side panels of thebox100.
• The[0073]hanger system150 provides several advantages. Thehanger system150 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. Thehanger system150 also permits complete collapse of the filledcontainer10 during the draining process without having to admit air into thecontainer10, thereby maintaining a closed system. Thesystem150 further provides support for refill deployment of thecontainer10 which minimizes undesirable pleating of thecontainer10. Thesystem150 forces the collapse of the container during draining to occur with predominately vertical wrinkles as opposed to horizontal creases that can prevent redeployment of thecontainer10 during refilling. This vertical collapsing configuration greatly improves the drainage performance of the container as the bottom panel of thecontainer10 is sucked convex upward defining lower drainage points on thecontainer10.
• FIGS. 22 and 23 disclose a further aspect of the invention. The[0074]flexible container10 is sized to be larger than thebox100. In this configuration, the amount of stress on the container seams is minimized if thecontainer10, for example, does not become optimally aligned within the box wherein the four comers of the container are substantially adjacent the four comers of the box. FIG. 22 discloses a schematic plan view of thecontainer10 within thebox100. Thecontainer10 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 thecontainer10 cooperate to define a first perimeter P1, 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 thecontainer10 are sized such that the first perimeter P1 is larger than the second perimeter P2. This allows for some “play” with respect to thecontainer10 within thebox100 and will provide a certain amount of wrinkles in thecontainer10 preferably at the comers of thecontainer10 andbox100. In a preferred embodiment, thecontainer10 is sized with respect to thebox100 so that the first perimeter P1 is about 2% to about 10% larger than the second perimeter P2 of thebox100. As shown in FIG. 23, when thecontainer10 is substantially filled with fluid within thebox100, wrinkles are formed in thecontainer10 at or near the corners. If thecontainer10 was sized substantially identically to thebox100, corners of thecontainer10 could pull away from the corners as shown in FIG. 24 thus putting more stress on thecontainer10. As shown in FIG. 25, a largersized container10 alleviates these potential problems wherein comers of thecontainer10 are optimally supported at corners of thebox100.
• FIGS.[0075]18-21 disclose aport closure300 according to the present invention designed to provide a unique closure for theport40 of thecontainer10. Theport closure300 provides both a sterile and gas permeable barrier. Theport closure300 generally includes acommunication member302, astop member304, acover member306 and aband308. Thecommunication member302 is typically in the form of a tube. Thetube302 is typically made from an elastomeric material such as silicone. The size of the tube can vary depending on the particular application. In one preferred embodiment, a ¾ in. tube is used. Thetube302 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 aplug304. Theplug304 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 theplug304 but prevents fluid from passing through theplug304. In one preferred embodiment, theplug304 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. Theplug304 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 thetube302. As further shown in FIGS.18-20, thecover member306 has afirst member310 and asecond member312. Themembers310,312 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, themembers310,312 are sealed to one another to form a two-ply, peelable pouch having an opening to receive the second end of thetube302. Theband308 is typically also made from elastic material such as silicone and can be cut from tube stock identical to the tube used in theport closure300.
• As further shown in FIG. 20, in constructing and connecting the[0076]port closure300 to thecontainer10, thetube302 is first cut to the desired length, e.g. 6-30 feet of tubing. Afirst end314 of thetube302 is inserted over theport40 on thecontainer10 to form an interference fit. Acable tie316 can be placed around thefirst end314 of thetube302 when installed on theport40 to more securely connect thetube302 over theport40. After tightening, thecable tie316 is trimmed accordingly. Theplug304 is cut into a one inch length from the desired plug stock. As shown in FIGS. 18 and 19, theplug304 is then inserted into asecond end318 of thetube302. A portion of theplug304 extends from the second end of thetube302 to allow the operator to grasp theplug304 on removal from thetube302. The first andsecond members310,312 of thecover306 are sealed to one another but leaving one open end320 (FIG. 20) to form apouch322. Thecover306 is then placed over thesecond end318 of thetube302 and plug304. Theband308 is then placed around thecover306 and thetube302 to secure thecover306 to thetube302. Because theelastic band308 is cut from tube stock identical to thetube302, when theband308 is placed around thetube302, it provides a radially compressive force on thecover306 against thetube302. Thecover306 provides a dustcover so that if thesecond end318 of thetube302 is inadvertently dropped on the floor or otherwise touch contaminated, theporous plug304 and tube end318 remains clean and sterile. If a tamper evident feature is desired, thecover member306 may be permanently affixed to thesecond end318 of thetube302 with a non-removable accessory such as a shrink band309 (FIG. 19). In addition, as shown in FIG. 18, thecover306 could be directly heat sealed to thetube302 thus providing a tamper evident feature.
• There are two general methods to access the[0077]plug304 at thesecond end318 of thetube302. As shown in FIG. 18,top edges324 of the first andsecond members310,312 can be peeled apart to open thecover306. Alternatively as shown in FIG. 19, theband308 can be rolled down thetube302 and thecover306 pulled away from thesecond end318 of thetube302. In either case, once thecover306 is removed, theplug304 can also be removed wherein the fluid can either be drained or pumped from thecontainer10.
• 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[0078]container10 having anadditional port330 closed by avent closure332. Thevent closure332 is similar to theport closure300 described above. Thevent closure332 has ashort silicon tube334 having one end connected to theadditional port330. Avent plug336 made from the same material as theport closure plug304 is inserted into the free end of thetube334. Thevent plug336 allows gases to pass therethrough to equalize pressure inside thecontainer10 to the pressure outside thecontainer10. Thevent plug336 enables complete filling of thecontainer10 and attendant reduction of headspace (i.e., the space of the 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 acontainer10 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), as well as compromising the container itself due to repeated mechanical stresses (flex cracking).
• As further shown in FIG. 21, if desired, a[0079]valve338 can be positioned within thetube334, or communication member, in between the first end and the second end. Thevalve338, such as a stopcock valve or other suitable valve, can be open or closed to allow or prevent venting of thecontainer10 as desired. For example, thevalve338 can be opened to vent thecontainer10 during the later stages of filling. Conversely, thevalve338 can be closed such as during shipping and draining.
• The[0080]port closure300 of the present invention provides numerous advantages, namely providing a sterile closure but still having gas-permeable properties. The sterile barrier prevents contamination. The permeable property of theclosure300 equalizes the internal pressure within thetube302, and therefore thecontainer10 that is in communication with thetube302, and the external pressure around thecontainer10. Pressure equalization allows sterile air to enter thecontainer10, which facilitates manipulation of thecontainer10 during handling and installation. For example, pressure equalization allows the large, flexible,collapsible container10 to be easily manipulated while empty, without the risk of introducing non-sterile air into thecontainer10. It is essential to have air in thecontainer10 during handling and installation, because the air acts as a lubricant allowing the container panels to move independently. However, having air in thecontainer10 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 thecontainer10 filled with fluid but with as little air as possible, and then to allow air to enter thecontainer10 without breaching sterility. The sterile, gas permeable port closure provides these advantages. If thesecond end318 of thetube302 is accidently dropped or introduced to contaminants, thecover member306 maintains thesecond end318 of thetube302 and plug304 sterile. In addition, theport closure300 does not require injected molded ports or stainless steel couplings, thus providing cost savings. Furthermore, by using an interference fit between thetube302 and plug304, no solvents are needed to connect theplug304 to thetube302, therefore reducing the amount of leachables into thecontainer10.
• 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.[0081]

Claims (23)

What is claimed is:

1. A flexible container comprising:

a plurality of panels joined together to form a sleeve, the panels each having an end edge that cooperate to define an imaginary plane at one end of the sleeve; and

an end panel connected to the panels at the one end of the sleeve, the end panel having at least one portion extending beyond the imaginary plane.

2. The container ofclaim 1 wherein the panels form a polygonal sleeve.

3. The container ofclaim 1 wherein the panels each have a second end edge that cooperate to define a second imaginary plane at another end of the sleeve, the container further comprising a second end panel connected to the panels at the other end of the sleeve, the second end panel having at least one portion extending beyond the second imaginary plane.

4. The container ofclaim 1 wherein the portion extends outwardly from the sleeve.

5. The container ofclaim 1 wherein the portion extends inwardly towards the sleeve.

6. The container ofclaim 1 wherein the plurality of panels comprises four panels cooperatively forming a sleeve having a generally rectangular cross-section.

7. The container ofclaim 6 wherein two opposing panels are gusseted panels.

8. The container ofclaim 7 wherein the gusseted panels have a gusset fold.

9. The container ofclaim 1 wherein the end panel is contiguous with the plurality of panels.

10. The container ofclaim 1 wherein the end panel comprises a plurality of connecting members.

11. The container ofclaim 10 wherein the connecting members converge to a point.

12. The container ofclaim 10 wherein the connecting members converge to a line.

13. The container ofclaim 10 wherein the connecting members converge to a polygon.

14. The container ofclaim 1 wherein one of the panels has a port.

15. The container ofclaim 1 wherein the port has a port closure connected thereto.

16. The container ofclaim 15 wherein the port closure comprises:

a tube having a first end and a second end, the first end adapted to be connected to the port;

a plug inserted into the second end of the tube, the plug being made from a gas permeable porous material;

a cover having a first member and a second member, the second end of the tube being positioned between the members, the members being sealed together at their respective peripheral edges; and

an elastic band wrapped around the cover and tube.

17. A flexible container comprising:

a plurality of panels joined together to form a sleeve, the panels each having an end edge that cooperate to define an imaginary plane at one end of the sleeve; and

an end panel connected to the panels at the one end of the sleeve, the end panel having a plurality of converging surfaces, the surfaces having at least one portion extending beyond the imaginary plane.

18. The container ofclaim 17 wherein the converging surfaces extend outwardly from the sleeve.

19. The container ofclaim 17 wherein the converging surfaces extend inwardly towards the sleeve.

20. The container ofclaim 17 wherein the panels each have a second end edge that cooperate to define a second imaginary plane at another end of the sleeve, the container further comprising a second end panel connected to the panels at the other end of the sleeve, the second end panel having a plurality of converging surfaces, the surfaces having at least one portion extending beyond the second imaginary plane.

21. A large volume flexible container capable of containing a fluid to be maintained under sterile conditions comprising:

a first panel, a second panel, a third panel, and a fourth panel connected together to form a generally cubic structure,

the first panel having a central segment adjacent an end segment, the central segment having a longitudinal edge and the end segment having a tapered edge extending from the longitudinal edge, an angle being defined between the longitudinal edge and the tapered edge, the angle being in the range from about 135.01° to about 138°.

22. The container ofclaim 21 wherein the angle is in the range from about 135.5° to about 136.5°.

23. The container ofclaim 21 wherein the angle is 136°.

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