巴西专利BR112014007807B1 container with film sprayer

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专利摘要:
FILM SPRAY CONTAINER A container set (13) includes a flexible bag having an inner surface enclosing a chamber (40) and an opposite outer surface, the bag having a top end wall (48), an end wall of bottom (50), and a surrounding side wall (42) extending between them, the bottom end wall including a first polymeric sheet (60) overlapping a second polymeric sheet (66). A first weld line welding the first polymer sheet to the second polymer sheet, the first weld line delimiting a first spray area formed between the first polymer sheet and the second polymer sheet. A plurality of first perforations are formed through a portion of the first polymeric sheet that overlaps the first spray area so that gas can pass from the first spray area, through the first perforations and into the bag chamber.
公开号:BR112014007807B1
申请号:R112014007807-6
申请日:2012-09-28
公开日:2020-11-17
发明作者:Michael E. Goodwin；Nephi D. Jones；Derik R. West
申请人:Life Technologies Corporation；
IPC主号:

专利说明:

BACKGROUND OF THE INVENTION 1. The Field of Invention
[001] The present invention relates to sprayers incorporated in a flexible bag. 2. The relevant technology
[002] Sprayers are commonly used in bioreactors to deliver controlled volumes of gas to a growth medium containing cells. In part, the gas is used to control the partial pressure of oxygen in the growth medium and to control the pH and other perimeters of the growth medium so that the conditions are optimal for cell growth. Sprayers typically comprise a hollow metal ring having a hose attached to it. The ring is formed by a sintered metal so that the ring is porous. The ring is positioned manually at the bottom of a container with the hose extending upwards through a port at the top of the container. During operation, pressurized gas is supplied to the ring through the hose. The gas then permeates through the metal ring in order to introduce the media in the form of small bubbles. As the bubbles rise through the media, at least a portion of the gas becomes entrenched within the media. Other conventional sprayers comprise a section of stainless steel tubing that is bent into a ring with small diameter holes positioned along its curved length.
[003] Although conventional sprayers are useful in supplying gas to the medium, they have a number of shortcomings. For example, conventional sprayers are relatively expensive to produce and are therefore designed to be reused. The reuse of a conventional sprayer, however, requires that it be removed from the container and then cleaned and sterilized. In some situations, spray cleaning can be difficult in which cell by-product, dead cells, and other particles within the growth medium can be housed in or trapped inside the spray. Thus, cleaning and sterilizing the sprayer can be both time-consuming and expensive. Time and care must also be taken to correctly position and seal the sprayer within the container without contaminating the sprayer or container.
[004] In addition, in conventional bioreactors, it is necessary that the growth medium containing the cells be continuously mixed or suspended so that the properties of the growth medium remain homogeneous. Conventional sprayers can block fluid flow, which can produce dead spots where cells die. In addition, the cells can be captured in or by the spray which can damage or kill the cells. In addition, sprayers must be carefully designed and positioned so that they do not obstruct the mixing system.
[005] Some current bioreactors comprise a flexible bag that is arranged inside a rigid support housing. The cell culture is grown inside the sterile compartment of the flexible bag. In an attempt to eliminate some of the above spray problems, disposable sprayers have been incorporated into the flexible bags. Such disposable sprayers comprise a port having an enlarged annular flange welded to the inside of the bag and a tubular rod projecting from the flange out of the bag. The rod delimits a passage that extends through the flange. A porous film overlaps the flange inside the bag to cover the passage and is welded around the perimeter edge of the flange. As a result, gas can be passed through the rod from outside the bag. The gas passes through the flange and then passes through the porous film where it enters the cell culture inside the bag in the form of small bubbles. When cell production is complete, the bag and associated sprayer are simply discarded.
[006] Although the flexible sprayer above eliminates some of the problems of conventional sprayers, the new bag sprayers also have their limitations. Most notably, bag sprayers only spray in a relatively small, fixed location in the bag and are limited to just one size of gas bubbles. As such, bag sprayers have little or no adjustment in relation to spraying at different locations, flow rates, bubble sizes, or combinations of the above.
[007] Therefore, what is needed are sprayers and container systems that can solve one or more of the above deficiencies. BRIEF DESCRIPTION OF THE DRAWINGS
[008] Various embodiments of the present invention will now be discussed with reference to the attached drawings. It should be understood that these drawings describe only typical embodiments of the invention and therefore should not be considered as limiting their scope.
[009] Figure 1 is a cross-sectional view of an embodiment of a container assembly within a support housing, a container assembly incorporating a sprayer;
[010] Figure 2 is an exploded perspective view of the bottom end wall of the container assembly shown in Figure 1;
[011] Figure 3 is a top plan view of the bottom end wall of the container assembly shown in Figure 1 showing the sprayers mounted thereon and a manifold coupled thereto;
[012] Figure 4 is a top plan view of the container assembly shown in Figure 3 having an alternative collector coupled thereto;
[013] Figure 5 is a top plan view of the bottom end wall shown in Figure 3, having a plurality of discrete gas lines coupled thereto;
[014] Figure 6 is a top plan view of a bottom end wall of a container assembly having an alternative configuration of the sprayers mounted thereon;
[015] Figure 7 is a top plan view of a bottom end wall of a container having an alternative embodiment of a sprayer mounted thereon;
[016] Figure 8 is an exploded perspective view of a bottom end wall of a container containing three leaves;
[017] Figure 9 is a side cross-sectional view of an alternative embodiment of a container assembly having sprayers extending downwardly through the bottom end wall;
[018] Figure 10 is a top plan view of the bottom end wall of the container shown in Figure 9;
[019] Figure 11 is a cross-sectional side view of one of the sprayers shown in Figure 9;
[020] Figure 12 is a perspective view of the floor of the support housing shown in Figure 9; and
[021] Figure 13 is a cross-sectional side view of an alternative type of sprayer where a gas line projects from the sprayer into the container. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[022] The present invention relates to film sprayers as well as container systems that incorporate such sprayers. In general, a film spray modality comprises overlapping sheets of flexible material in which one or more weld lines weld the sheets together so that a spray area is bounded between the overlapping sheets. A gas line is in communication with the spraying area to supply a gas to it while perforations are formed through one of the sheets so that the gas passing into the spraying area can pass out through the perforations for spraying a fluid . Film sprayers are typically incorporated into a flexible bag or other type of container to spray a fluid inside the container or to otherwise deliver gas bubbles to the fluid inside the container.
[023] Described in Figure 1 is a modality of a containment system 10 incorporating features of the present invention. Containment system 10 comprises a substantially rigid support housing 12 in which a container assembly 13 is arranged. Support housing 12 has an upper end 14, a lower end 16, and an inner surface 18 delimiting a compartment 20. Formed at the lower end 16 is a floor 22. A side wall surrounding 23 extends from the floor 22 towards the upper end 14. As will be discussed in more detail below, one or more openings 24 may extend across the floor 22 or side walls 23 of the support housing 12 in order to communicate with the compartment 20. Upper end 14 ends in a flap 26 delimiting an inlet opening 28 for compartment 20. If desired, a cover, not shown, can be mounted on the upper end 14 to cover the inlet opening 28. Likewise, an access opening can be formed elsewhere in the support housing 12 such as through the side wall 12 at the second end 16 or through the floor 22. The access opening is large enough for an operator to reach hoist through the access opening to help manipulate and position container assembly 13. The access opening can be selectively closed by a door or cover plate.
[024] It should be understood that the support housing 12 can come in a variety of different sizes, shapes and configurations. For example, floor 22 can be flat, frustoconical, or have other slopes. Sidewall 23 may have a cross section that is circular, polygonal or have other configurations. Support housing 24 can be insulated and / or coated so that a heated or cooled fluid can flow through the jacket for heating or cooling the fluid contained within container assembly 13. Compartment 20 can be of any desired volume such as those discussed below with respect to container 32.
[025] As also illustrated in Figure 1, the container assembly 13 is at least partially arranged inside the compartment 20 of the support housing 12. Container assembly 13 comprises a container 32 having one or more doors 52 mounted thereon. In the embodiment shown, the container 32 comprises a flexible bag having an inner surface 38 delimiting a chamber 40 suitable for containing a fluid 41 or other type of material. More specifically, container 32 comprises a side wall 42 which, when container 32 is inflated, can have a substantially circular or polygonal cross section that extends between a first end 44 and an opposite second end 46. The first end 44 ends at a wall top end 48 while the second end 46 ends at a bottom end wall 50.
[026] Container 32 may consist of one or more sheets of flexible water-impermeable material such as low density polyethylene or other polymeric sheets with a thickness typically in the range of about 0.1 mm to about 5 mm and about 0.2 millimeters to approximately 2 millimeters being more common. Other thicknesses can be used. The material may consist of a single layer of material or may comprise two or more layers that are either sealed together or separated to form a double-walled container. When the layers are sealed together, the material may comprise a laminated or extruded material. The laminated material may comprise two or more layers formed separately which are then attached together by an adhesive.
[027] The extruded material may comprise a single integral sheet comprising two or more layers of different materials that are separated by a contact layer. All layers are simultaneously coextruded. An example of an extruded material that can be used in the present invention is HyQ CX3-9 film available from Hyclone Laboratories, Inc. of Logan, Utah. HyQ CX3 -9 film is a 9 mil, three-layer molded film produced in a cGMP installation. The outer layer is a polyester elastomer coextruded with a contact layer of ultra-low density polyethylene product. Another example of an extruded material that can be used in the present invention is the HyQ CX5-14 molded film, also available from Hyclone Laboratories, Inc. The HyQ CX5-14 molded film comprises an outer layer of polyester elastomer, a layer contact layer of ultra-low density polyethylene, and an EVOH barrier layer disposed between them. In yet another example, a multi-web film produced from three independent blown film webs can be used. The two inner webs are each 4 mil monolayer polyethylene film (which is referred to by HyClone as the HyQ BM1 film) while the outer barrier web is a 5.5 mil thick 6 layer coextrusion film (a which is referred to by HyClone as the HyQ BX6 film).
[028] The material can be approved for direct contact with living cells and be able to maintain a sterile solution. In such an embodiment, the material can also be sterilized such as by ionizing radiation. Examples of materials that can be used in different situations are disclosed in United States Patent No. 6,083,587 issued on July 4, 2000, and United States Patent Publication No. US 2003/0077466 Al, published on 24 April 2003, which are each incorporated by reference.
[029] In one embodiment, container 32 comprises a two-dimensional pillow-style bag in which two sheets of material are placed in overlapping relationship and the two sheets are bounded together on their peripheries to form an inner chamber 40. Alternatively , a single sheet of material can be folded over and sewn around the periphery to form an inner chamber 40. In another embodiment, the container 32 can be formed from a continuous tubular extrusion of polymeric material that is cut to length and the ends closed by sewing.
[030] In still other embodiments, container 32 may comprise a three-dimensional bag that not only has a ring-shaped side wall, but also a two-dimensional top end wall 48 and a two-dimensional bottom end wall 50. For example, the container three-dimensional structure 32 may comprise side wall 42 formed from a continuous tubular extrusion of polymeric material which is cut to length as shown in Figure 2. A circular top end wall 48 (Figure 1) and bottom end wall 50 they can then be welded to the opposite ends of side wall 42. In yet another embodiment, the three-dimensional container 32 can be formed from a plurality of discrete panels, typically three or more, and most commonly between 4-6. Each panel can be substantially identical and comprises a side wall portion 42, top end wall 48, and bottom end wall 50 of container 32. The perimeter edges of adjacent panels are sewn together to form container 32. The seams are typically formed using methods known in the art, such as heat energies, RF energies, sonic energy, or other sealing energies. In alternative embodiments, the panels can be formed in a variety of different patterns.
[031] It is recognized that container 32 can be manufactured to have almost any desired size, shape, and configuration. For example, container 32 can be formed with chamber 40 sized for 10 liters, 30 liters, 100 liters, 250 liters, 500 liters, 750 liters, 1000 liters, 1500 liters, 3000 liters, 5000 liters, 10000 liters or other desired volumes . Chamber 40 can also have a volume ranging from about 10 liters to about 5000 liters, or about 30 liters to about 1000 liters. Any other intervals selected from the volumes mentioned above can also be used. Although container 32 can be of any shape, in a embodiment container 32 is specially configured to be complementary or substantially complementary to the compartment 20 of the support housing 12.
[032] In any embodiment, however, it is usually desirable that when container 32 is received inside compartment 20, container 32 is generally uniformly supported by support housing 12. Having at least generally uniform support of container 32 per support housing 12 helps to prevent container 32 failure by hydraulic forces applied to container 32 when filled with fluid.
[033] Although in the above-discussed embodiment container 32 is in the form of a flexible bag, in alternative embodiments it is appreciated that container 32 may comprise any form of foldable container, flexible container, or semi-rigid container. In addition, in contrast to having a closed top end wall 48, the container 32 may comprise an open top liner. Container 32 may also be transparent or opaque and may have ultraviolet light inhibitors incorporated therein.
[034] Mounted on the top end wall 48 there are a plurality of ports 52 that are in fluid communication with chamber 40. Although two ports 52 are shown, it is appreciated that one or three or more ports 52 may be present depending on the use container 32. As such, each port 52 may serve a different purpose, depending on the type of processing to be performed. For example, ports 52 can be coupled to a tube 54 for dispensing fluid or other components into chamber 40 or withdrawing fluid from chamber 40. In addition, such as when container 32 is used as a bioreactor for culturing cells or microorganisms, ports 52 can be used to provide various probes, such as temperature probes, pH probes, dissolved oxygen probes, and the like, accessing chamber 40. It should be noted that ports 52 they can come in a variety of different configurations and can be placed in any number of different positions in container 32, including side wall 42 and bottom end wall 50.
[035] Although not required, in one embodiment, means are provided for mixing fluid 41 within chamber 40. The means for mixing may be in the form of a mixing set. By way of example and not by limitation, in one embodiment, as shown in Figure 1, a drive shaft 56 projects into chamber 40 and has a rotor 58 mounted at its end. A dynamic seal 59 forms a seal between the shaft 56 and the container 32. External rotation of the drive shaft 56 facilitates the rotation of the rotor 58 which mixes and / or suspends fluid 41 inside the chamber 40. Specific examples of how to incorporate a set of mixing mixture within a flexible container are disclosed in US Patent No. 7,384,783 issued June 10, 2008 and 7,682,067 issued March 23, 2010, which are hereby incorporated by specific reference.
[036] In yet another alternative embodiment of the mixing means or the mixing assembly, mixing can be achieved by vertically alternatingly moving a vertical mixer inside the chamber 40. Additional disclosure regarding the assembly and operation of the vertical mixer is disclosed in the Publication US Patent No. 2006/0196501 published September 7, 2006, which is incorporated herein by specific reference. In still other embodiments, it is envisaged that mixing can be accomplished simply by circulating the fluid through chamber 40, such as using a peristaltic pump to move the liquid in and out of chamber 40; by rotating a magnetic rotor or stirring bar inside the container 32 and / or by injecting sufficient gas bubbles into the fluid to mix the fluid. Other conventional mixing techniques can also be used.
[037] Continuing with Figure 1, bottom end wall 50 has a plurality of sprayers incorporated. Specifically, bottom end wall 50 comprises a first leaf 60 having a first side face 62 and a second opposite side face 64. The first leaf 60 overlaps a second leaf 66 which also has a first side face 68 and a second side face opposite 70. The first sheet 60 and the second sheet 66 typically comprise flexible polymer sheets such as those discussed above with respect to container 32. As discussed above with respect to the bottom end wall 50, the first sheet 60 can comprise a web that is welded to the side wall 42 around a perimeter edge 69 as shown in Figure 2. Alternatively, first sheet 60 may comprise an integral portion of the side wall 42 or may comprise a plurality of separate sheets fastened together or that are attached to or are an integral portion of the side wall 42. Second sheet 66 can be welded to the second side face 64 of the blade first sheet 60 and / or welded to the side wall 42, such as along a perimeter edge 71 of the second sheet 66. In other embodiments, the second sheet 66 may be welded or comprise an integral portion of the side wall 42, such as discussed above with respect to the first sheet 60, while the first sheet 60 is welded or otherwise attached to the first side face 68 of the second sheet 66 and / or to the side walls 42.
[038] A top plan view of the first sheet 60 overlapping the second sheet 66 is described in Figure 3. In this embodiment, sheets 60 and 66 are welded together by a weld line 72. Weld line 72, as with other lines welding techniques discussed here, can be formed using any conventional technique, such as laser welding, sonic welding, heat welding, or the like. Weld line 72 is shown as welding together the perimeter or outer edges of the sheets 60 and 66, but can be formed radially inward from one or both edges of the perimeter, or at other locations. As also shown in Figure 3, four separate sprayers 74A-D are formed by producing other weld lines between sheets 60 and 66.
[039] For example, sprayer 74A is formed by forming a weld line 76A starting at a first location 78A positioned at or adjacent to the perimeter edge of sheet 60 and / or sheet 66 and extending into sheets 60 and 66 along a predetermined path to sprayer 74A and then circulates back to a second location 80A at or adjacent to the perimeter edge of leaf 60 and / or leaf 66 adjacent to first location 78A. Welding line 7 6A delimits a perimeter of a spray path 82a which is the area bounded between sheets 60 and 66 and partially surrounded by welding line 76A. In the illustrated embodiment, spray path 82A comprises a gas transfer path 84A extending from a first end 86 to an opposite second end 88. An opening 87A is formed at the first end 86 between locations 78A and 80A and between sheets 60 and 66 through which a gas can be fed to the gas transfer path 84A. Spray path 82A also comprises a spray area 90A formed at the second end 88 which is in fluid communication with the gas transfer path 84A. In the embodiment shown, the gas transfer path 84 is a narrow and elongated path, while the spray area 90 forms an enlarged circular area. Other settings can also be used.
[040] A plurality of perforations 92 extends through the first sheet 60 of the spray area 90A so that the gas can pass along the gas transfer path 84A, to the spray area 90A and then through the perforation 92 to form gas bubbles within the fluid 41 disposed inside the chamber 40. Sprayers 74B-D are also formed with equal reference characters being used to identify like elements. Using this technique, a plurality of discrete sprayers can be easily formed in container 32. Each sprayer can be arranged in any desired location and be of any desired size, shape or configuration. Likewise, although four sprayers 82 are shown, it is appreciated that any number of sprayers such as 1, 2, 3, 5, or more, can be formed with sheets 60 and 66. The spray areas can be evenly distributed over the leaves 60 and 66, or can be located in defined locations for optimal spraying. For example, a sprayer may be arranged directly below the mixing means, such that the mixing or movement of fluid 41 produced by the mixer helps to trap the gas bubbles within the fluid 41.
[041] In some embodiments, each sprayer can have the same number of perforations 92 and all perforations 92 can be of the same size and shape. In alternative embodiments, perforations 92 may be different between two or more different sprayers. For example, different sprayers may have different numbers, sizes and / or shapes of perforations 92 to optimize performance in different situations. Larger perforations 92 produce larger gas bubbles that can be optimal for removing CO2 from fluid 41 whereas smaller perforations produce smaller bubbles that may be preferred to oxygenate fluid 41. Likewise, increasing the number of perforations 92 can be useful in making the bubbles mix the liquid and / or increase oxygen removal. In other embodiments, it is appreciated that one or more of the 74A-D sprayers can have combinations of different perforations 92. For example, a single spray can have small and large perforations 92. In one embodiment, small bubbles are formed from perforations 92 typically with a diameter of less than 0.8mm, 0.4mm or 0.2mm, 0.1mm, while large bubbles are formed from perforation typically having a diameter greater than 1.5mm , 0.8mm, 0.4mm or 0.15mm. Perforations of other diameters can also be used. The size of the perforation and resulting bubbles depends on the intended use and the size of the container 32. For example, large bubbles are typically larger when processing a large volume of fluid in a large container than when processing a relatively small volume of fluid in a container little. The variance or delta between the diameter of the perforations for small bubbles and the perforations for large bubbles is typically at least 0.15mm, 0.3mm, 0.5mm or 1mm and is often + / - 0.1 mm, or +/- 0.5 mm of these values. Other variances can also be used.
[042] As discussed in more detail below, 74A-D sprayers can operate simultaneously or, alternatively, a manifold or other regulator can be used so that one or more of the sprayers can be operated while the other sprayers are not operated. Therefore, by having different sprayers with different perforations 92, selected sprayers can be used in different situations or moments to optimize performance.
[043] In some embodiments, it is considered that the gas transfer path 84A from sprayer 74A is not necessary. For example, perforations 92 can be formed through the first sheet 60 overlapping the gas transfer path 84A in order to convert the gas transfer path 84A into a portion of the spray area 90A. It should be noted that perforations 92 can be formed using any of the conventional techniques. For example, perforations 92 can be formed as part of the manufacturing process for the sheet or can be produced subsequently by punches or other techniques. In one embodiment, one or more lasers can be used to form perforations 92. An advantage of using a laser is that perforations 92 can be formed in precise locations and with a precise diameter so that bubbles can be formed having a precise preset size. In addition, when a laser is used to form a perforation, the material melted by the laser gathers around the perimeter edge of the perforation, thereby reinforcing the perforation and helping to prevent the sheet from breaking.
[044] In one embodiment of the present invention, a manifold can be used to control the flow of gas to one or more of the 74A-D sprayers. For example, illustrated in Figure 3 is an embodiment of a collector 100 incorporating features of the present invention. Collector 100 comprises a body 102 having a gas inlet port 104 and a plurality of gas outlets 106A-D. Gas outlet ports 106A-D are in parallel communication with gas inlet port 104 via a bifurcated flow path 108. A gas source, such as a compressor or a compressed gas cylinder, is fluidly coupled with the gas inlet port 104. The gas may be air, oxygen, or any other gas or combination of gases. Gas lines 110A-D extend from the gas outlet ports 106A-D, respectively, to a corresponding opening 87A-D at the first end 86 of each sprayer 74A-D, respectively. Gas lines 110A-D can be welded between sheets 60 and 66 in openings 87A-D in order to seal closed openings 87A-D. 110A-D gas lines can comprise flexible or rigid tubes and can be formed integrally with or separately attached to the body 102.
[045] 112A-D valves are mounted on body 102 and control the gas flow for each 110A-D gas line, respectively. In one embodiment, 112A-D valves can be electric valves, such as solenoid valves, which can be used to open, close or restrict the flow of gas to 74A-D sprayers. In this embodiment, electrical wiring 114 can be coupled to valves 112A-D to control its operation. In other embodiments, 112A-D valves may include valves that are operated manually, hydraulically, pneumatically, or otherwise. By using collector 100, different sprayers or different combinations of sprayers can be used at different heights to optimize performance as discussed above.
[046] An alternative embodiment of a collector 100A is described in Figure 4 in which similar elements between collector 100 and 100A are identified by the same reference characters. Collector 100A includes body 102 with 110A-D gas lines projecting from it and communicating with 74A-D sprayers. In the collector 100A, the gas lines 110A-D comprise flexible piping. In turn, the manifold 100 has valves 114A-D in the form of clamps or hose clamps that are mounted on gas lines 110A-D, respectively. It is appreciated that clamping clips 114 can come in a variety of different configurations and are used to manually tighten gas lines 110A-D in order to control the flow of gas through them.
[047] In other alternative modalities, it is appreciated that a collector is not necessary. For example, as shown in Figure 5, gas lines 110A-D can extend from sprayers 74A-D and have valves 114A-D coupled to them, respectively. However, 110A-D gas lines do not need to be part of or coupled with a collector, but can be coupled separately for discrete gas sources if desired.
[048] As discussed earlier, any desired number, size, shape and / or configuration of sprayers can be formed. For example, illustrated in Figure 6 is a top plan view of the bottom end wall 50 having three sprayers 118A-C formed thereon. Again, the perimeter of each sprayer 118A-C is formed by welding lines 120A-C, respectively, formed between sheets 60 and 66. If applicable, a single weld line can form a common boundary between adjacent sprayers. . For example, welding line 120B is shown forming a common boundary between sprayers 118B and 118C. Sprayer 120A is similar to sprayer 74A, sprayer 118A is expected to be located more centrally on sheets 60 and 66. Sprayer 118B has a substantially C-shaped spray area 122B that curves around the spray area 122 A. Likewise , spray 118C has a spray area 122C that circulates substantially around the spray area 122B.
[049] In contrast to the previous sprayers, sprayer 118C has a first end 124 and an opposite second end 126 with gas lines 110A and 110D fluidly coupled thereto, respectively. In this configuration, a gas can be supplied through both gas lines 110A and 110D at opposite ends of spray 118C so that gas is more uniformly supplied to spray area 122C. As a result, the gas exits all of the perforations 92 at a more uniform pressure and flow rate. Once again, the gas flow in each of the 118A-C sprayers can be controlled by the collector represented 100A or any other type of collector.
[050] In the embodiment illustrated in Figure 6, rotor 58 (Figure 1) can be vertically aligned with sprayer 118A while sprayer 118C is laterally removed from rotor 58. Sprayer 118 can be designed to produce small bubbles that interact with and are distributed by the rotor 58 through the fluid. By dispersing the small bubbles through the rotor 58, the small bubbles have a longer residence time inside the fluid, which increases the mass transfer of gas. For example, bubbles can more efficiently oxygenate the fluid. 118C sprayer produces larger bubbles that do not interact directly with rotor 58. Larger bubbles are commonly used to remove CO2 from the fluid. Because larger bubbles have greater buoyancy than smaller bubbles, the rotor has less influence on the larger bubbles, so there may be no need to align them with the rotor. In addition, the rotor can break larger bubbles making them less efficient at removing CO2. In addition, alignment of the larger bubbles with the rotor can cause the rotor to cavitate which reduces the mixing efficiency of the fluid. In other embodiments, however, sprayer 118 can be designed to produce large bubbles that are intentionally broken and dispersed by rotor 58, while sprayer 118C produces small bubbles that do not interact directly with rotor 58. Other configurations can also be used.
[051] In another embodiment, it may be desirable to have a single spray that covers a large part of the bottom end wall 50 so that the fluid within the container can be more uniformly sprayed. For example, illustrated in Figure 7 is a sprayer 130 having a first end 134 and an opposite second end 136 with a perimeter bounded by welding lines 132A and 132B extending between them. Sprayer 130 is elongated and extends along the bottom end wall 50 in a curved pattern. Sprayer 130 has a spray area 130, that is, the area between the welding lines 132A and 132B, which covers at least 40% and most commonly at least 50%, 60% or 80% or the surface area on one side bottom end wall 50. Other percentages can also be used. Gas lines 110A and 110B are coupled with the opposite ends of the sprayer 130 so that a gas can be delivered to the opposite ends of the sprayer 130. As a result, the gas is passed more evenly out through the perforations 92 than if it were only a single gas line is used.
[052] With reference to Figure 8, in an alternative embodiment, sprayers of the invention can be formed by overlapping three or more leaves. For example, one or more welding lines can weld sheet 60 to sheet 66 to form a spray, represented by dashed lines 141A between them. Likewise, one or more weld lines can weld sheets 66 and 140 together to form a spray, represented by dashed lines 141B, between them. An opening 142 can be formed through sheet 60 to expose the spray area of spray 141B formed between sheets 66 and 140. It is also appreciated that the weld lines can simultaneously weld all three sheets 16, 60, and 140 together to form sprayer 141A and / or 141B. Gas lines 110A and B couple to and deliver gas to sprayers 141A and 141B, respectively.
[053] In the previous embodiments, the gas lines supplying gas to the sprayers enter through an opening, such as the openings 87A-D in Figure 3, formed between the sheets 60 and 66. This configuration allows the gas lines to project radially out from the side of the container 32 and thus project through an opening 24 (Figure 1) on the side of the support housing 12. In an alternative embodiment, however, the gas lines can fluidly couple with the spray nozzles so as to project down from the bottom of the bottom end wall 50 and in turn project down through the floor 22 of the support housing 12. For example, as shown in Figure 9, bottom end wall 50 of the container 32 is again composed of first sheet 60 overlapping second sheet 66 which are welded together to form sprayers 144A-C. Specifically, in the top plan view as shown in Figure 10, weld lines 146A-C weld sheets 60 and 66 together and are each formed in a circular pattern in order to connect a perimeter of spray areas 148A-C, respectively. In the alternative embodiment, it is assumed that the solder lines 146A-C can be formed in any surrounding pattern. Sprayers 144A-C also include perforations 92 formed through the first sheet 60 overlapping each spray area 148.
[054] As shown in Figures 9 and 11, a port 152A has a flange 153 which is mounted on the first side face 68 of the second sheet 66 so that a rod 154 extends down through an opening 156 in the sheet 66. As a result , port 152A communicates with spray area 148A of spray 144A. Ports 152B and C are also coupled with sprayers 144B and C. As shown in Figure 9, a first end of gas lines 110A-C is coupled with ports 152A-C, respectively, while a second opposite end of gas lines 110A -C is coupled with the collector 100. As a result, the collector 100 can be used to control selective operation of each of the 144A-C sprayers. Again, 144A-C sprayers can be of any desired size, shape or configuration.
[055] Depending on the desired configuration for the containers and sprayers, it is appreciated that the containers can be assembled using a variety of different processes. For example, before or after cutting sheets 60 and 66 to the desired size, perforations 92 can be formed on the first sheet 60 having the desired number, size, shape and location. Likewise, where applicable, openings 156 can be formed in the second sheet 66 and doors 152 welded thereto. Then sheets 60 and 66 can be superimposed and the various weld lines formed in order to weld sheets 60 and 66 together and produce the sprayers. Whenever doors 156 are not used, gas lines can be welded inside the opening formed between sheets 60 and 66 in order to communicate with the sprayers. Finally, sheets 60 and 66 can be welded to side wall 42. Alternatively, sheet 60 can be welded to side wall 42 and then second sheet 66 can be welded to first sheet 60 to weld the sheets together and form the sprayers. In still other embodiments, first sheet 60 may be integrally formed with side wall 42 or side wall 42 and first sheet 60 may comprise several sections that are welded together. In these configurations, second sheet 66 would subsequently be welded to the combination of first sheet 60 and side wall 42. In other embodiments, second sheet 66 can be attached or integrally formed with side wall 42 while first sheet 60 may comprise a smaller sheet or several smaller sheets covering only a second portion of sheet 66. Since the gas lines are coupled with different sprayers and, where appropriate, a collector attached to them, all gas lines and ports attached to the container are closed and the complete set is sterilized by radiation or other traditional techniques.
[056] For ease of use, the container assembly 13 is lowered into compartment 20 of support housing 12. The related collector and / or multiple lines are then passed out of compartment 20 through opening 24, when support housing 12 shown in Figure 1 is used. In the embodiment shown in Figure 9, the collector and gas lines can pass down through an elongated opening 24A formed on the base 22 of support housing 12 A. In both embodiments, a plate 158 can be used to help cover a opening portion 24 or 24A after the collector is passed through it in order to minimize the size of the openings. This cover of the openings reduces stress on the container caused by fluid trying to push the container through the openings. Container assembly 13 can be partially inflated with a gas after being positioned inside support housing 12 to allow it to be adjusted manually and properly positioned inside support housing 12. Alternatively, container assembly 13 can be filled with fluid while it is adjusted to the proper position. Container set 13 can later be used as a bioreactor, fermenter, or simply for processing fluids or chemicals.
[057] In another alternative embodiment of the present invention, the gas lines can fluidly couple with sprayers in order to project upwardly from the top of the bottom end wall 50 and, in turn, couple with or extend out through of a door 52 (Figure 1) located at the upper end of the container 32. For example, as shown in Figure 13, bottom end wall 50 of the container 32 is again composed of first sheet 60 overlapping second sheet 66 which are welded together to form a sprayer 160. Specifically, in the same manner as discussed above with reference to Figure 10, a weld line 162 can weld sheets 60 and 66 together in a circular pattern in order to limit a perimeter of a spray area 164. In alternative embodiments, it is appreciated that the weld line 162 can be formed in any surrounding pattern and that any number of separate sprayers 160 can be formed. It is again appreciated that the first sheet 60 only needs to be large enough to form sprayer 160 or several sprays 160 and does not need to be as large as the second sheet 66. Sprayer 160 also includes perforations 92 formed through the first sheet 60 overlapping the spray area 164.
[058] Flange 153 of port 152 is mounted on the second side face 64 of the first sheet 60, for example, by welding or adhesive, so that the rod 154 extends out through an opening in the sheet 66. As a result, port 152 communicates with the spray area 164. A first end 168 of a gas line 171 is coupled with a barbed end 155 of port 152 while a second opposite end 172 of gas line 171 is either coupled with or extends out through a of ports 52 (Figure 1) of container 32. It should be noted that port 52 to which gas line 171 engages or extends outwards may be located at the upper end of container 32, as shown in Figure 1, or may be located anywhere along side wall 42 or floor 50. A method for coupling the second end 172 of gas line 171 to port 52 is disclosed in U.S. Patent No. 7,225,824, issued June 5, 2007 which is incorporated here by special reference specifies. In turn, the second end 172 of the gas line 171 can be placed in communication with a gas source to supply gas to the sprayer 160. The gas line 171 can also be coupled with a collector that can control the gas flow to several separate sprayers 160 formed on the bottom end wall 50.
[059] Inventive sprayers and related containers are recognized to have a variety of unique advantages over conventional sprayers. For example, the sprayers of the invention can be easily formed by simply soldering two sheets together. This welding can be achieved using the same equipment and techniques used in forming the container. This ease of manufacture allows greater versatility in the formation of sprayers of desired size, orientation, configuration, location, number and the like, to optimize the desired processing parameters. In addition, the sprayers are flexible and form part of the bag or container. This allows the combined container and sprayers to be easily rolled or folded, without the potential risk of damage to the assembly. The rolled or folded set can be easily sterilized, stored, transported, and incorporated into a rigid support housing. The ability to produce multiple sprayers at the bottom of the bag also allows sprayers to be formed with different sizes of perforations so that different sizes and bubble numbers can be selectively produced to achieve different goals. In addition, through the collectors, operation of the different sprayers or combinations of spraying sprayers can be controlled to further optimize processing parameters. Because the combined container and sprayers are relatively inexpensive to make, the set can be designed as a disposable, single-use item, thus eliminating cleaning and sterilization between uses. The sprayers are also aligned with the floor so that they do not obstruct the flow of fluid or the flow of cells or microorganisms within the fluid.
[060] The present invention can be realized in other specific forms without departing from its spirit or essential characteristics. The described modalities should be considered in all aspects only as illustrative and not restrictive. The scope of the invention is therefore indicated by the appended claims and not by the previous description. All changes that come within the meaning and scope of equivalence of the claims must be embraced within their scope.

权利要求:
Claims (19)
[0001]
1. Container assembly, characterized by the fact that it comprises: a flexible bag having an inner surface limiting a chamber and an opposite outer surface, the bag having a top end wall, a bottom end wall, and a side wall surrounding extending between them, the bottom end wall being comprised of a first polymeric sheet overlapping a second polymeric sheet; a first weld line by welding the first polymer sheet to the second polymer sheet, the first weld line delimiting a perimeter of a first spray path formed between the first polymer sheet and the second polymer sheet, the first spray path comprising a first path gas transfer extending from a first end to a second opposite end and a first spray area formed at the second end and communicating with the first gas transfer path; and a plurality of first perforations being formed through a portion of the first polymeric sheet that overlaps the first spray area so that gas can pass from the first spray area, through the first perforations and into the bag chamber.
[0002]
2. Container set according to claim 1, characterized by the fact that the first gas transfer path is restricted in relation to the first spray area.
[0003]
Container assembly according to claim 1, characterized in that the first gas transfer path is elongated while the first spray area is substantially circular.
[0004]
4. Container assembly according to claim 1, characterized by the fact that there are no perforations extending through the portion of the first polymeric sheet that overlaps the first gas transfer path.
[0005]
Container assembly according to claim 1, characterized in that it further comprises a first gas line coupled with the first end of the first gas transfer path.
[0006]
Container assembly according to claim 1, characterized in that it further comprises a first gas line welded between the first polymeric sheet and the second polymeric sheet.
[0007]
7. Container assembly according to claim 1, characterized by the fact that it also comprises a hole formed in the second polymeric sheet, a port attached to the second polymeric sheet and extending through the orifice, and a first gas line coupled with the door.
[0008]
8. Container assembly according to claim 1, characterized by the fact that it further comprises: a second weld line welding the first polymer sheet to the second polymer sheet, the second weld line delimiting a second spray area formed between the first polymeric sheet and the second polymeric sheet; and a plurality of second perforations being formed through a portion of the first polymer sheet that overlaps the second spray area.
[0009]
9. Container assembly according to claim 8, characterized by the fact that it also comprises a collector in fluid communication with the first spray area and the second spray area.
[0010]
10. Container assembly according to claim 9, characterized by the fact that the collector comprises: a first valve that regulates the flow of gas through the collector and to the first spray area; and a second valve that regulates the flow of gas through the collector and to the second spray area.
[0011]
11. Container assembly according to claim 9, characterized by the fact that the collector comprises: a body with a gas inlet port and a plurality of gas outlets, the gas inlet in fluid communication with each of the plurality of gas outlet ports; a first gas line being in fluid communication with the first spray area and a first of the gas outlet ports; and a second gas line being in fluid communication with the second spray area and a second of the gas outlet ports. first perforations have a different size or number than the second perforations.
[0012]
Container assembly according to claim 8, characterized by the fact that the first perforations have a different size or number than the second perforations.
[0013]
13. Container assembly according to claim 1, characterized by the fact that it also comprises a rigid support housing delimiting a compartment, the flexible bag being disposed inside the support housing compartment.
[0014]
14. Container assembly, characterized by the fact that it comprises: a flexible bag having an inner surface delimiting a chamber and an opposite outer surface, the bag having a bottom end wall being comprised of a first polymeric sheet overlapping a second polymeric sheet ; a first weld line by welding the first polymeric sheet to the second polymeric sheet, the first weld line delimiting a first spray area formed between the first polymeric sheet and the second polymeric sheet, a plurality of first perforations being formed through a portion of the first polymeric sheet that overlaps the first spray area; and a second weld line by welding the first polymeric sheet to the second polymeric sheet, the second weld line delimiting a second spray area formed between the first polymeric sheet and the second polymeric sheet, a plurality of second perforations being formed through a portion of the first polymeric sheet overlapping the second spray area, the first spray area being separated from the second spray area.
[0015]
15. Container assembly according to claim 14, characterized by the fact that it also comprises a collector in fluid communication with the first spray area and the second spray area.
[0016]
16. Container assembly, characterized by the fact that it comprises: a flexible bag having an inner surface delimiting a chamber and an opposite outer surface, the bag having a bottom end wall comprised of a first polymeric sheet overlapping a second polymeric sheet; at least one weld line by welding the first polymer sheet to the second polymer sheet, to at least one weld line delimiting an elongated spray area formed between the first polymer sheet and the second polymer sheet and extending between a first end and a second end opposite, a plurality of perforations being formed through a portion of the first polymer sheet that overlaps the first spray area; a first gas line coupled to the first end of the spray area; and a second gas line coupled with the second end of the spray area.
[0017]
17. Container assembly according to claim 16, characterized by the fact that it comprises a collector coupled with the first gas line and the second gas line. spraying covers at least 40% of the surface area on one side of the bottom end wall.
[0018]
18. Container assembly according to claim 16, characterized in that the spray area covers at least 40% of the surface area on one side of the bottom end wall.
[0019]
19. Container assembly according to claim 16, characterized by the fact that it further comprises a rigid support housing delimiting a compartment, the flexible bag being disposed within the support housing compartment.

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JP2014534808A|2014-12-25|

WO2013049692A1|2013-04-04|

US10843141B2|2020-11-24|

CN106635740A|2017-05-10|

US20170197185A1|2017-07-13|

US20190329192A1|2019-10-31|

BR112014007807A2|2017-04-18|

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US9643133B2|2017-05-09|

IN2014DN02477A|2015-05-15|

CN104114266A|2014-10-22|

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法律状态:
2019-08-13| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2020-07-07| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2020-11-17| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 28/09/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

US201161541913P| true| 2011-09-30|2011-09-30|

US61/541,913|2011-09-30|

PCT/US2012/058086|WO2013049692A1|2011-09-30|2012-09-28|Container with film sparger|

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