Patent Application
20110044567
The invention relates to a 3D container (D for dimension), comprising a rigid frame, a deformable receptacle, and a functional means for treatment of the contents, including an internal element that is located inside the container, especially designed for shipping, storage or treatment of biopharmaceutical fluids. The invention also relates to a unit that comprises such a container and a rigid support that can ensure that it is held.
Flexible pouches for medical use that have two large flexible walls joined at their periphery have been known for a long time. Such pouches, once expanded, remain relatively thin, which justifies the fact that they are often called “pillow” pouches or “2D” pouches (D meaning dimension). Such a small-capacity 2D pouch for individual and one-time use is described according to a particular embodiment in the document U.S. Pat. No. 4,559,053. In this embodiment, the pouch comprises two foldable films made of plastic material and a semi-rigid frame that has a central opening, whereby the two films are welded on the two large surfaces of the semi-rigid frame, through whose wall passes the input/output ports. The invention does not relate to the 2D containers or pouches.
The document FR-A-2 781 202 describes a container that has two large walls and two side gussets. Each gusset comprises two small walls that are connected to one another by an inside fold, and each small wall is connected to the adjacent large wall by an outside fold. Such a container, once expanded, assumes a three-dimensional shape (cylindrical, prismatic, parallelepipedic, . . . ) and can have a volume of 50 liters and even more, which justifies the fact that it is termed 3D.
In the case of a 3D container that is intended in the biopharmaceutical field to be substituted for a traditional stainless steel tank, it is desirable to transfer functions previously executed in the tank to the flexible container. This problem is not posed in the case of 2D containers or pouches. In addition to the input and output of the contents of the container or components of its contents, these functions are typically mixing, aeration, measuring (collecting) data, and pumping. The execution of such functions requires using devices that comprise one or more elements that are solid and that take up a certain amount of space, with more or less simple or distorted shapes, that may or may not be rigid, stationary or mobile, in particular forming part of the group that comprises the rods, shafts, propellers or mixing elements, aerators, pipes . . . placed in the container itself.
The document US-A-2006/0131765 describes a container that is used as a bioreactor, designed to accommodate contents in the fluid state. This container comprises a flexible or non-rigid part and a rigid part. According to the embodiments, the container is open or closed hermetically, and it comprises one or more input/output ports. The rigid part forms a small plate and comprises a protuberance that is located in the container. The rigid part is used as a support for an internal element for treatment of the contents of the container, such as a mixing element or an aerator. Such an embodiment exhibits the drawback that an internal element that is solid and that takes up a certain amount of space, with a more or less simple or distorted shape (with pointed or sharp-edged contours), rigid or non-rigid, stationary or mobile, can damage the flexible part that is made of plastic film if they come into contact with one another.
The document U.S. Pat. No. 6,494,613 describes a mixing container that is designed to accommodate contents in the fluid state. This container comprises a flexible bag and a sheath or flexible tube that passes through the wall of the bag hermetically and is housed in the bag. An essentially rigid rod of predetermined shape is placed in the sheath or tube and projects from the bag. It is driven by an engine. Such an embodiment exhibits the drawback of being complex and having limited scope, for example ill-suited in the case of a functional means for treatment of the contents of the container, such as a means for mixing, aeration, measuring (collecting) data, and pumping.
The document U.S. Pat. No. 7,249,880 describes an embodiment of the same type as the preceding one.
Furthermore, the document US-A-2003/0029982, whose object is a large-capacity (or three-dimensional) flexible container for shipping, storage and distribution of liquids, in this case therapeutic fluids or fluids for other medical applications, describes a system for suspension and a system for support for such a container.
Foldable containers of the type comprising one or more rigid frames and a wall that is attached to this—or these—frames are known (see, for example, the document US-A-2008/0011759). However, such containers are not suitable for being able to constitute 3D containers, sterile for single use, for biopharmaceutical fluids that have to accommodate functional means for treatment of the contents of the container, such as a means for mixing, aeration, measuring (collecting) data, and pumping.
The document DE-A-1 301 970 describes a container that comprises a receptacle that has a flexible side wall that has an open free edge that is deformable so as to be able to be in two extreme states, respectively folded flat on itself and expanded in volume, and one or more rigid frames that are hollow and that comprise a transverse opening that is delimited by a side wall that is closed peripherally on itself with which the open free edge of the side wall is made integral. An upper rigid frame and a lower rigid frame comprise a transverse wall opposite the transverse opening. An intermediate rigid frame comprises two opposite transverse openings. In its transverse wall, the upper rigid frame comprises a filling opening and an air vent. Such a container is not suitable per se for shipping, storage or treatment of biopharmaceutical fluids when it is necessary to provide, in the very container, the presence of one or more elements that are solid and that take up a certain amount of space, with shapes that are more or less simple or distorted (with pointed or sharp-edged contours), that may or may not be rigid, stationary or mobile, in particular forming part of the group that comprises rods, shafts, propellers or mixing elements, aerators, pipes, . . . .
Finally, containers that have a large capacity but that are not suitable in the case of biopharmaceutical fluids and do not provide the presence in the container of one or more elements, such as those that were just mentioned, are known (JP-A-04072187, DE-U-20 2006 003 886 and EP-A-0 559 337).
There is therefore a need for sterile, disposable 3D containers, typically for the biopharmaceutical field, designed to contain biopharmaceutical fluids, which are flexible—at least partially, with large capacities—so as to be able to be substituted in traditionally used rigid tanks and which can integrate functional means for treatment of the contents of the container, for example a means for mixing, aeration, measuring (collecting) data, and pumping. There is a need for 3D containers of this type that also are easy to produce, have an acceptable cost in relation to their use, are easy in their logistical management in particular because of their polyvalence, and finally are free from the risk of damage during storage or shipping because of the presence in the container itself of one or more elements that are solid and that take up a certain amount of space, with more or less simple or distorted shapes (in particular with pointed or sharp-edged contours), rigid or not, stationary or mobile, such as those that are part of the group that comprises rods, shafts, propellers or mixing elements, aerators, pipes, . . . . There is also the requirement that the containers of this design can be presented in several different embodiments that can meet the various needs.
The object of the invention is to overcome the problems of the known 3D containers and to meet these needs.
For this purpose, the invention proposes a large-capacity container that is designed for fluid contents, comprising:
According to the embodiments, a connecting port is a pass-through, including a through hole, or, in contrast, is not a pass-through and is located inside the inside space delimited by the frame.
According to one embodiment, the container comprises at least two connecting ports that are arranged opposite one another on either side of the container.
According to one embodiment, the container also comprises at least one input/output port.
According to the embodiments, a port is located on the side wall or on the transverse end wall of the frame.
According to a first embodiment, the at least one internal element is housed in an inside space that is delimited by the side wall of a single frame. According to a second embodiment, the at least one internal element is housed in an inside space that is formed by the two inside spaces opposite the two frames facing one another.
According to a first embodiment, the—or at least a portion of the—side wall of the receptacle is located essentially in the extension of the shell that forms the side wall of the frame. According to a second embodiment, the—or at least a portion of the—side wall of the receptacle is located transversely apart from the shell that forms the side wall of the frame.
According to the embodiments, the side wall of the receptacle is arranged in a foldable and expandable accordion or with foldable and expandable gussets.
According to the embodiments, the functional means for treatment of the contents is a mixing means, an aeration means, a means for measuring (collecting) data, or a pumping means.
According to the embodiments, the internal element of the functional means for treatment of the contents belongs to the group that comprises rods, shafts, propellers or mixing elements, aerators, and pipes.
According to one embodiment in the case where the container comprises two transverse openings on either side of the side wall, the airtight engagement with the side wall, around each of the two transverse openings, with the free edge of a receptacle, is provided, whereby the container comprises the frame and the two receptacles in communication with one another and located on either side of the frame.
According to one embodiment in the case where the container comprises two transverse openings on either side of the side wall, there is also provided a transverse median wall that is located between the two transverse openings that have an airtight bonding with the side wall, whereby the side wall is formed by two side sub-walls, each associated with each of the two transverse openings, whereby the container comprises the frame and the two receptacles, and whereby without communication with one another, they are separated by the transverse median wall and are located on either side of the frame that forms two back-to-back sub-frames.
According to one embodiment in the case where the container comprises a transverse opening on either side of the side wall and a transverse end wall, the airtight engagement with the side wall, around the transverse opening, of the free edge of a receptacle is provided, the container comprising the frame and a receptacle located beside the frame where the transverse opening is located.
In this last embodiment and according to a variant, the container also comprises a second receptacle that is located beside the frame where the transverse end wall is found, whose open free edge is integrated, in an airtight manner, around said transverse end wall.
According to the embodiments, the two receptacles are either identical or similar or different, in particular by their capacities.
According to the embodiments, the component parts of the frame are an integral part of the frame either to be brought into production together or to be assembled and integrated.
According to the embodiments, a transverse median wall or a transverse end wall is either rigid (flat or curved) or deformable (elastic or inelastic).
According to the embodiments, a transverse median wall or a transverse end wall, with the side wall of the frame, has a rigid bonding or a flexible bonding.
According to one embodiment, the frame is made of plastic material.
According to one embodiment, the container is opaque, whereby the functional treatment means is sensitive to light.
According to a first embodiment, a receptacle is integrally deformable, being made in the form of a plastic film pouch. According to a second embodiment, a receptacle is partially deformable, being made in the form of a sheath or sleeve made of plastic film, and partially not deformable, including a rigid part in the form of a plate. In this case, and according to one embodiment, the rigid part in the form of a plate is located opposite the frame. According to one embodiment, the rigid part in the form of a plate is a transverse end wall or a transverse median wall that is part of a frame.
According to another aspect, the purpose of the invention is a container whose receptacle(s) contain(s) one or more biopharmaceutical fluid(s).
According to another aspect, the purpose of the invention is a unit comprising, on the one hand, a 3D container as it was described above, and, on the other hand, a rigid support that can ensure that the container is held.
Several embodiments of the invention and different variants will now be described using the drawings in which:
A container 1 that is flexible (at least partially) and with large capacity (or 3D, according to the terminology of the art) is designed to be substituted for a rigid tank such as the ones traditionally used in the biopharmaceutical field. Very specially, this container 1 can be sterilized, is disposable, and is able to accommodate a biopharmaceutical fluid. Such a container 1 is specially designed for shipping, storage or treatment of the biopharmaceutical fluid that it contains.
According to the applications, the container 1 is closed or open, and, if necessary, provided with input/output ports 9c that are necessary to its operation, such as one or more ports for filling the container 1 with its contents or the components of its contents and one or more drainage ports that are preferably placed in the lower position of the container 1.
The container 1 first comprises a rigid, hollow frame 2 that delimits an inside space 3.
The frame 2 comprises a side wall 4 that is closed peripherally on itself. On at least one side of the side wall 4, the frame 2 comprises a transverse opening 5.
The container 1 has a primary XX axis that is orthogonal to the primary plane P of the frame 2.
In the drawings, the XX axis is shown vertical, which corresponds to a position of use of the container 1, when the latter contains contents. The frame 2 then extends horizontally, the plane P being horizontal.
According to other variants, not shown, the XX axis is arranged horizontally. In this case, the frame 2 extends vertically, the plane P being vertical.
If necessary, the relative position of the container 1 relative to the horizontal and to the vertical is changed during the process of use of the container 1. For example, it passes from one vertical arrangement to the horizontal or vice versa.
Secondly, the container 1 comprises two side walls 7 in the form of film, made integral with it in an airtight manner by each of its two free open edges 6 and constituting or being part of two receptacles 8 that are at least partially deformable.
These two receptacles 8 are placed on either side of the frame 2, along the XX axis, one 8a in the lower part and the other 8b in the upper part.
In one embodiment, the receptacle 8 is inelastic or substantially inelastic, which does not rule out that it can be either folded or expanded. In another embodiment, the receptacle 8 has a certain extension capacity.
A film such as the one that is used for the creation of the receptacle 8 is typically made of single-layer or multi-layer thermoplastic polymers.
In a first embodiment (
The side wall 4 of the frame 2, according to this first embodiment, satisfies several functions.
The first function of the side wall 4 is to ensure the airtight engagement, around a transverse opening 5, of the free edge 6 of the side wall 7 of the receptacle 8. In this way, it is possible to produce an airtight container 1 that has the rigid frame 2 and the two deformable receptacles 8.
The second function of the side wall 4 is to support or to include at least one pass-through connection port 9a or at least one non-pass-through connection port 9b, and, if necessary, at least one input/output port 9c.
In the first embodiment of
Here, “port” means a means for connection or physical bonding as described below.
The purpose of such a physical connection means can be, in a first possibility, to ensure a function of holding an element, where the form of this holding can be varied and the degree of this holding can be more or less significant: attachment, rotating or sliding support, centering, . . . whereby this list is not exhaustive.
In this case, and according to a first variant, such a physical connection means can be a pass-through, the port being designated a “pass-through connection port” 9a (
According to a second variant, such a physical connection means can be a non-pass-through, whereby the port is designated “non-pass-through connection port” 9b (
In this case, such a pass-through connection port 9a or a non-pass-through connection port 9b is designed to hold an element 11 that is part of a functional treatment means 10.
The purpose of such a physical connection means can be, in a second possibility, to ensure a function of passage and communication of material (such as the contents of the container or the components of its contents), whereby the port is designated “input/output port” 9c.
Such an input/output port 9c is able to make possible the filling of the container 1 with its contents or the components of its contents, or its draining.
In its second function, the side wall 4 of the frame 2 supports or includes one or more ports, including at least one pass-through connection port 9a or non-pass-through connection port 9b. If necessary, the side wall 4 supports several pass-through connection ports 9a and/or non-pass-through connection ports 9b. The container 1 can thus hold the internal element 11 of the functional treatment means 10. If necessary, the container 1 holds several internal elements 11 of the same or several functional treatment means 10.
In addition, the side wall 4 of the frame 2 can support or include, in addition to the pass-through connection port(s) 9a or non-pass-through connection port(s) 9b, one or more input/output ports 9c.
These ports 9a, 9b, 9c extend in directions orthogonal to the XX axis, in this case in horizontal directions.
The third function of the side wall 4, according to this same first embodiment of
Thus, the internal element 11 can be completely—or essentially completely—housed in this inside space 3, which makes it possible to prevent the risk of damage of the container 1 as a result of the presence in the container 1 itself of one or more internal elements 11 that are solid and that take up a certain amount of space, with more or less simple or distorted shapes (in particular with pointed or sharp-edged contours), rigid or not, stationary or mobile. The frame 2 thus acts as protective housing for the internal element 11, but also for the receptacle 8.
Thirdly, the container 1 comprises the functional treatment means 10 of the contents that are in the container 1, namely the biopharmaceutical fluid, associated with the container 1. If necessary, the container 1 comprises several functional treatment means 10 for the same function or different functions.
A functional treatment means 10 such as the one that is considered here is designed to execute functions that act on the contents of the container, such as typically the mixing, aeration, measurement (collection) of data, and pumping. These functions were conventionally executed on the traditional rigid tanks that were used up until now in the biopharmaceutical field. The functions that were just mentioned are only exemplary and in no way limiting.
The embodiment of such functions makes it necessary to use one or more elements 11 that are solid and that take up a certain amount of space, with more or less simple or distorted shapes, rigid or not, stationary or mobile. These elements 11 are part of the group that comprises rods, shafts, propellers, or mixing elements, aerators, and pipes. This list is only exemplary and in no way exhaustive.
Such an—or such—element(s) 11 are placed inside the container 1 itself; this is why the element 11 can be termed an internal element.
If necessary, an element 11 also comprises a part 25 that is located outside of the container 1 or else another element 25 that extends the element 11 and is located outside of the container 1, forming part of the functional treatment means 10. Such a part or element 25 can be part of the group that comprises rods, shafts, pipes, engines, supply tube, drain, instrumentation, . . . , whereby this list is only exemplary and in no way exhaustive.
In the first embodiment that is shown in
The frame 2 is typically made of plastic, rigid, being specified that in certain embodiments described below, it can comprise a flexible transverse wall.
In the embodiments shown in the figures, the frame 2, and therefore its side wall 4, has a square or rectangular contour. Other forms can be considered.
The frame 2 comprises a lower surface 12, an outside surface 13, and two side edges 14 that define, in the first embodiment of
In the first embodiment of
The inside surface 12, on its side, is extended enough in the axial direction so as to be able to make possible the arrangement of the pass-through port(s) 9a, 9c and the non-pass-through connection port 9b.
A pass-through port 9a, 9c usually comprises an outside projecting part 21, such as a collar, delimiting the hole 20.
A free edge 6 of the side wall 7 of the receptacle 8 is made integral with any suitable location of the frame 2, for example with a projecting part 13a of the outside surface 13. This engagement is done by any suitable process, such as by welding.
In the first embodiment of
In the first embodiment of
The side wall 4 is arranged like an accordion, folded here.
In the embodiment that is being considered, a port 9a, 9b, 9c is an integral part of the frame 2, having come from production, here, with its side wall 4.
In the first embodiment of
Because of its deformable nature, a receptacle 8—when it is empty of its contents—can be folded flat on itself and against the adjacent side edge 14 of the frame 2, beside the transverse opening 5 with which the receptacle 8 is associated. Such is the case of the container 1 before use, for example during storage before use, or during shipping.
Taking into account that the axial size H is at least equal to the axial dimension h, as indicated, the internal element 11 is completely housed or substantially housed in the inside space 3, and it follows that this internal element 11, even solid and taking up a certain amount of space, of a more or less simple or distorted shape (including with sharp-edged or pointed contours), rigid or not, stationary or mobile, does not run the risk of damaging the component film of the receptacles 8a, 8b, even when the container 1 is folded (
Thus, the side wall 4 also acts as a spacer between an internal element 11 of the functional treatment means 10 and the component film of a receptacle 8.
When necessary, the receptacle 8 can be expanded in volume from the side of the transverse opening 5 with which the receptacle 8 is associated. Such is the case when the container 1 is to accommodate its contents or the components of its contents (
In one possible variant, the frame 2 is opaque. This structural arrangement is particularly suitable in the case of functional means 10—more specifically internal elements 11—able to be sensitive to light, such as photosensitive sensors.
In the second embodiment of
This solid median wall 17 can, according to the variants, be rigid and, in this case, flat or, in contrast, curved—which makes it possible, for example, to form a functional cavity—or any other more or less complex shape that is desired. According to other embodiments, it can be deformable and, in this case, elastic, or, in contrast, inelastic.
With an embodiment of the frame 2 comprising such a median wall 17, the side wall 4 of the frame 2 is formed by two side subwalls 4a and 4b, one associated with each of the two transverse openings 5. The frame 2 thus forms two back-to-back subframes 2a, 2b. Such a frame 2 is thus specially designed for the creation of a container 1, closed or open, comprising, in addition to the frame 2, the two receptacles 8a, 8b that, here—and contrary to the first production described above—are without communication with one another, being separated by the solid transverse median wall 17. These two receptacles 8a, 8b are located on either side of the frame 2, as above, whereby this frame is arranged in median position. With this embodiment, the frame 2 can have, in all, an axial size that is double that of the frame 2 according to the first embodiment.
Such a frame 2 with two sub-frames 2a, 2b defines two inside spaces 3a, 3b, which are not in communication with one another, being separated by the transverse median wall 16.
The side wall 4 and the transverse median wall 17 are an integral part of the frame 2, having come from production together or having been assembled subsequently.
In the third embodiment of
This end wall 18 can, according to the variants, be rigid and in this case flat or, in contrast, curved—which makes it possible, for example, to form a functional cavity—or any other more or less complex shape that is desired. It can, according to other variants, be deformable and in this case elastic or, in contrast, inelastic.
Whether it is a matter of the transverse median wall 17 or the transverse end wall 18, its bonding with the side wall 4 of the frame 2 is either a rigid bonding, in particular when these walls 17, 18 are themselves rigid, or a flexible bonding.
In one variant embodiment, the transverse end wall 18 is also able to support or include one or more pass-through connection ports 9a and/or non-pass-through connection ports 9b and/or input/output ports 9c that are similar to those described above in relation to the side wall 4 of the frame 2. One or more ports are added or substituted—completely or only partially—to the port(s) provided on the side wall 4 of the frame 2 and described above. One or more ports 9a, 9b make it possible to hold an internal element 11 that is completely housed in the space 3.
The side wall 4 and the transverse end wall 18 are an integral part of the frame 2, having come from production together or having been assembled subsequently.
While the container 1 according to this third embodiment comprises a single receptacle 8 that is located beside the frame 2 where the transverse opening 5 is located, it can be provided, according to a variant of this third embodiment (not shown), that the container 1 comprises, in addition to this receptacle 8—constituting a “first” receptacle—, a “second” receptacle that is at least partially deformable and is located beside the frame 2 where the transverse end wall 18 is located. The open free edge 6 of the side wall of this second receptacle is made integral, in an airtight manner, around the transverse end wall 18.
When the container 1 comprises two receptacles 8a, 8b, the latter are either identical or similar or different, in particular because of their capacities.
In the embodiments described above, a receptacle 8 is integrally deformable, being made in the shape of a bag or pouch of plastic film arranged like an accordion.
In the fourth embodiment of
According to the variants of this fourth embodiment (not shown), the rigid part 19 can consist of a transverse end wall 18 or a transverse median wall 17 that is part of a second frame 2 of the general type that is described above. The container 1 then comprises two frames 2, one median and the other end, and two receptacles 8.
In the fifth embodiment of
When the container 1 is folded, the two spaces 3a and 3b together form a large space 3a+3b, being in communication with one another.
The two frames 2a, 2b are or are not identical. Each of these two frames 2a, 2b has a transverse end wall 18. These two frames 2a, 2b are connected by a sheath that is generally cylindrical in shape and is made of a deformable plastic film that is arranged like an accordion.
A variant of the third embodiment of
A variant of the fifth embodiment of
A variant of the variant that was just described in relation to the
The structural arrangement according to which the internal element 11 is housed within an inside space (3a+3b) that is formed by the two inside spaces (3a and 3b) in relation to the two frames (2a, 2b) facing one another makes it possible to take advantage of the presence of a frame 2a, 3b at each of the two ends of the container 1 while preventing the one 2a of the frames with which the internal element 11 is associated from having an axial dimension that is at least equal to that of the internal element 11, with the result of increasing the axial dimension of the folded container 1, as it is shown in
The different embodiments and variants described show the flexibility that the design offers according to the invention and in particular that it is possible to provide not a single frame 2 but several frames 2a, 2b and that each component part of the frame 2 can be usefully used to support or include a port 9a, 9b or 9c.
The invention also relates to a container 1 as it was just described, including the receptacle(s) 8 that contain(s) one—or more—biopharmaceutical fluids.
The invention also relates to a unit that comprises, on the one hand, a container 1 as it was just described, and, on the other hand, a rigid support (not shown) that can ensure that the container 1 is held.
Such a rigid support comprises, according to a typical embodiment, a lower transverse rigid wall and an erect, side, peripheral, axial, rigid wall, limiting an upper transverse opening for access to a defined housing, the inside surfaces of the side and lower walls, able to accommodate the container 1, the receptacle 8 filled with biopharmaceutical fluid that is applied against these inside surfaces.
Such a rigid support is described in a particular embodiment in the document EP-A-1 012 073.
A container 1 as it was just described can have a volume of between 1 liter and 3,500 liters.
| Number | Date | Country | Kind |
|---|---|---|---|
| 0801699 | Mar 2008 | FR | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/FR09/50313 | 2/27/2009 | WO | 00 | 11/4/2010 |
