Ejector device for a biological treatment system and method of manufacturing the same

Abstract

An injector device (100) includes: an injector tube (102) having opposite distal ends, an inlet opening, and a plurality of injector holes along the longitudinal extent of the injector tube (102) between the opposite distal ends; and a central hub (104) coupled to the injector tube (102) at a point intermediate the opposite distal ends of the injector tube (102), the central hub (104) having a fluid passage in fluid communication with the injector tube (102) via the inlet opening.

Description

Technical Field

[0001] Embodiments of the present invention generally relate to bioprocessing systems and methods, and more particularly to a sparger device for a single-use bioreactor system. Background Art

[0002] A variety of vessels, devices, components, and unit operations are known for performing biochemical and / or biological processes and / or manipulating liquids and other products of such processes. To avoid the time, expense, and difficulty associated with sterilizing vessels used in biopharmaceutical manufacturing processes, single-use or disposable bioreactor bags and single-use mixer bags are used as such vessels. For example, biological materials (e.g., animal cells and plant cells) (including, for example, mammalian cells, plant cells, or insect cells and microbial cultures) can be processed using disposable or single-use mixers and bioreactors.

[0003] Increasingly, single-use or disposable containers are used in the biopharmaceutical industry. Such containers can be flexible or collapsible plastic bags supported by an external rigid structure (such as a stainless steel shell or vessel). Using sterile disposable bags eliminates the time-consuming step of cleaning the vessel and reduces the possibility of contamination. The bag can be positioned within the rigid vessel and filled with the desired fluid for mixing. An agitator assembly disposed within the bag is used to mix the fluids. Existing agitators are top-driven (having a shaft extending downward into the bag with one or more impellers mounted on the shaft) or bottom-driven (having an impeller disposed in the bottom of the bag driven by a magnetic drive system or motor located outside the bag and / or vessel). Most magnetic agitator systems include a rotating magnetic drive head located outside the bag and a rotating magnetic agitator (also referred to as an "impeller" in this context) located within the bag. The movement of the magnetic drive head enables torque transmission and thus rotation of the magnetic agitator, thereby allowing the agitator to mix the fluids within the vessel.

[0004] Depending on the fluid being processed, a bioreactor system may include many fluid lines and different sensors, probes, and ports connected to the bag for monitoring, analysis, sampling, and liquid transfer. For example, a harvesting port is typically located at the bottom of a disposable bag and vessel and allows a harvesting line to be connected to the bag for harvesting and discharging the bag. In addition, existing bioreactor systems typically utilize an ejector to introduce a controlled amount of a specific gas or gas combination into the bioreactor. The ejector outputs small bubbles into the liquid so that the gas is stirred and / or dissolved in the liquid or used for carbon dioxide stripping. Delivering gas via an ejector helps to mix substances, thereby maintaining a uniform environment throughout the bag's interior, and is sometimes essential for cell growth in the bioreactor. Ideally, the ejector and agitator are in close proximity to ensure optimal distribution of gas throughout the container.

[0005] A common type of sparger is generally T-shaped and connects to a gas supply line extending to the bottom of a bioreactor vessel. The sparger extends upward into the interior of the vessel / single-use bag to deliver gas to the culture within the internal volume. This type of sparger is typically manufactured from three component parts: a vertical hub with a central passageway and two opposing tube sections with multiple longitudinally spaced holes that form T-arms extending horizontally outward from the vertical hub. The central passageway of the hub is in fluid communication with the opposing tube sections to deliver gas to the tube sections, which enter the culture through the holes along the longitudinal extent of the tube sections. Such sparger devices are typically manufactured by intersecting vertical and horizontal rods to form a T-shape and then molding around the rods to form a hub. The rods are then removed, leaving a T-shaped passageway in the hub. The opposing tube sections are then connected to the hub so that they are in fluid communication with the T-shaped passageway.

[0006] Due to the three-piece construction of the injector and the molding method used to manufacture the hub, the gas delivery holes along the opposing tube sections may not be evenly spaced from the hub. That is, due to the way each tube section is positioned in the hub, the holes on one tube section may be positioned closer to the hub than the corresponding holes on the opposing tube section. This can lead to reverse flow near the hub, which can cause trapped cell debris inside the tube section. In addition, due to the dead space in the tube section beyond the last gas delivery hole, the injector can easily cause cells / media to accumulate at the distal end of the tube section. Furthermore, because the vertical portion of the hub is not particularly rigid, the injector can rock around the interior of the bag and contact the impeller, bag, and / or sensor, which is undesirable.

[0007] In view of the above, there is a need for an improved injector device that significantly minimizes the likelihood of cell accumulation within the injector, is less prone to deflection, and can be produced from a variety of materials. In conjunction with such an injector device, there is a need for a manufacturing method that achieves more repeatable well positioning and is simpler and less expensive than existing methods. Summary of the Invention

[0008] In an embodiment, an ejector device is provided. The ejector device includes: an ejector tube having opposite distal ends, an inlet opening, and a plurality of ejection holes along the longitudinal extent of the ejector tube between the opposite distal ends; and a central hub coupled to the ejector tube at a point intermediate the opposite distal ends of the ejector tube, the central hub having a fluid passage in fluid communication with the ejector tube via the inlet opening.

[0009] In another embodiment, a method of manufacturing an ejector device is provided. The method includes the steps of providing a tube having opposite distal ends and an inlet opening in a sidewall of the tube between the opposite distal ends; inserting a pin into the inlet opening; overmolding around the pin and the tube to form a central hub; and removing the pin to form a supply passage within the central hub, the supply passage being in fluid communication with an interior of the tube via the inlet opening.

[0010] In yet another embodiment, a bioprocessing system is provided. The bioprocessing system includes: a vessel; a flexible bioprocessing bag positionable within the vessel; and an sparger device coupled to a fluid port in the flexible bioprocessing bag, the sparger device including a sparger tube having opposite distal ends, an inlet opening, and a plurality of sparger holes along the longitudinal extent of the sparger tube between the opposite distal ends; the central hub coupled to the sparger tube at a point intermediate the opposite distal ends of the sparger tube; the central hub having a fluid passage in fluid communication with the sparger tube via the inlet opening.

[0011] In yet another embodiment, an injector device is provided. The injector device includes: at least one injector tube having a distal end and a plurality of injector holes along the longitudinal extent of the injector tube; a hub coupled to the injector tube, the hub having a fluid passageway in fluid communication with a central passageway of the injector tube for supplying gas to the injector tube; and a cap on the distal end of the injector tube, the cap having a through-bore in fluid communication with the central passageway of the injector tube. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The present invention will be better understood by reading the following description of non-limiting embodiments with reference to the accompanying drawings, in which:

[0013] Figure 1 is a front elevation view of a bioreactor system according to an embodiment of the present invention.

[0014] Figure 2 yes Figure 1 Simplified side elevation cross-sectional view of a bioreactor system.

[0015] Figure 3 yes Figure 1 Simplified top plan view of a bioreactor system.

[0016] Figure 4 is a method for Figure 1 A top plan view of an eductor apparatus used in conjunction with a bioreactor system.

[0017] Figure 5 It is along Figure 4 The line BB intercepts Figure 4 Cross-sectional view of the ejector assembly.

[0018] Figure 6 yes Figure 5 Detailed enlargement of area C.

[0019] Figure 7 yes Figure 4 An enlarged side elevation view of an ejector assembly.

[0020] Figure 8 It is used for manufacturing Figure 4 A specific cross-sectional view of the mold assembly of the ejector device.

[0021] Figure 9 yes Figure 4 An enlarged partial cross-sectional view of a distal end of an injector device illustrating a cover of the injector device according to an embodiment of the present invention.

[0022] Figure 10 yes Figure 4 FIG. 1 is an enlarged partial cross-sectional view of a distal end of an injector device illustrating a cover of an injector device according to another embodiment of the present invention.

[0023] Figure 11 According to another embodiment of the present invention Figure 4 An enlarged partial cross-sectional view of the distal end of the ejector device. DETAILED DESCRIPTION

[0024] Hereinafter, reference will be made in detail to exemplary embodiments of the present invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference characters are used throughout the drawings to refer to the same or like parts.

[0025] As used herein, the terms "flexible" or "collapsible" refer to structures or materials that are pliable or capable of bending without breaking, and may also refer to compressible or expandable materials. An example of a flexible structure is a bag formed from polyethylene film. The terms "rigid" and "semi-rigid" are used interchangeably herein to describe a "non-collapsible" structure, i.e., a structure that does not fold, collapse, or otherwise deform to significantly reduce its extended dimension under normal forces. Depending on the context, "semi-rigid" may also refer to a structure that is more flexible than a "rigid" element, such as a bendable tube or catheter, but still refers to a structure that does not collapse longitudinally under normal conditions and forces.

[0026] "Vessel," as the term is used herein, means a flexible bag, a flexible container, a semi-rigid container, a rigid container, or a flexible or semi-rigid tube, as appropriate. As used herein, the term "vessel" is intended to include bioreactor vessels having flexible or semi-rigid walls or portions of walls, single-use flexible bags, and other containers or conduits commonly used in bioprocessing or biochemical processing, including, for example, cell culture / purification systems, mixing systems, media / buffer preparation systems, and filtration / purification systems. As used herein, the term "bag" means a flexible or semi-rigid container or vessel, for example, used as a bioreactor or mixer for contents located therein.

[0027] Embodiments of the present invention provide bioreactor systems and sparger devices for use with bioreactor systems. In one embodiment, the sparger device for a bioprocessing system is formed as a two-piece assembly and includes: a sparger tube having opposite distal ends, an inlet opening, and a plurality of sparger holes along the longitudinal extent of the sparger tube between the opposite distal ends; and a central hub coupled to the sparger tube at an approximate midpoint of the sparger tube, the central hub having a fluid passage in fluid communication with the sparger tube via the inlet opening. The sparger device is formed by inserting a core pin into the inlet opening in the sparger tube to form an interference fit, overmolding around the core pin and the sparger tube to form the central hub, and removing the core pin to provide a supply passage in fluid communication with the sparger tube via the inlet opening.

[0028] refer to Figure 1 and Figure 2 , a bioreactor system 10 according to an embodiment of the present invention is shown. The bioreactor system 10 includes a substantially rigid bioreactor vessel or support structure 12 mounted atop a base 14 having a plurality of legs 16. The vessel 12 can be formed, for example, from stainless steel, a polymer, a composite, glass, or other metal, and can be cylindrical in shape, however, other shapes can also be utilized without departing from the broader aspects of the present invention. The vessel 12 can be equipped with a lifting assembly 18 that provides support to a single-use flexible bag 20 disposed within the vessel 12. The vessel 12 can be of any shape or size so long as it is capable of supporting the single-use flexible bioreactor bag 20. For example, according to one embodiment of the present invention, the vessel 12 is capable of accepting and supporting a 10-2000 L flexible or collapsible bioprocess bag assembly 20.

[0029] The vessel 12 may include one or more viewing windows 22 that allow one to view the fluid level within the flexible bag 20, and a window 24 positioned at a lower region of the vessel 12. The window 24 allows access to the interior of the vessel 12 for inserting and positioning various sensors and probes (not shown) within the flexible bag 20, and for connecting one or more fluid lines to the flexible bag 20 for adding or withdrawing fluids, gases, etc. from the flexible bag 20. The sensors / probes and control equipment are used to monitor and control important process parameters, including any one or more and any combination of the following: for example, temperature, pressure, pH, dissolved oxygen (DO), dissolved carbon dioxide (pCO2), mixing rate, and gas flow rate.

[0030] Specific reference Figure 2 , a schematic side elevational cross-sectional view of the bioreactor system 10 is shown. Figure 2 As shown in the single-use flexible bag 20 is disposed within the vessel 12 and constrained by the vessel 12. In an embodiment, the single-use flexible bag 20 is formed of a suitable flexible material (such as a homopolymer or copolymer). The flexible material can be a USP Class VI certified material, for example, silicone, polycarbonate, polyethylene, and polypropylene. Non-limiting examples of flexible materials include polymers such as polyethylene (e.g., linear low density polyethylene and ultra low density polyethylene), polypropylene, polyvinyl chloride, polyvinyl dichloride, polyvinylidene chloride, ethylene vinyl acetate, polycarbonate, polymethacrylate, polyvinyl alcohol, nylon, silicone rubber, other synthetic rubbers and / or plastics. In an embodiment, the flexible material can be a laminate of several different materials, such as, for example, Fortem® available from GE Healthcare Life Sciences. TM Laminates, Bioclear TM 10 laminate and Bioclear 11 laminate. Portions of the flexible container may comprise a substantially rigid material, such as a rigid polymer, for example high density polyethylene, metal or glass. The flexible bag may be supplied pre-sterilized, such as using gamma irradiation.

[0031] The flexible bag 20 houses an impeller 28 attached to a magnetic hub 30 located at the bottom center of the interior of the bag, which rotates on an impeller plate (not shown) also located on the interior bottom of the bag 20. The impeller 28 and hub 30 (and, in some embodiments, the impeller plate) together form an impeller assembly. A magnetic drive 34 located on the exterior of the vessel 12 provides the motive force for rotating the magnetic hub 30 and impeller 28 to mix the contents of the flexible bag 20. Although Figure 2The use of a magnetically driven impeller is shown, but other types of impellers and drive systems, including top driven impellers, are possible.

[0032] If also Figure 2 As shown in FIG, flexible bag 20 houses an ejector device 100 that is engageable with a port (not shown) on the bottom of flexible bag 20 that receives a supply of gas from gas supply line 36. Ejector device 100 extends upwardly into the interior volume defined by flexible bag 20 and is positioned adjacent impeller 28. Figure 2 This is intended to illustrate the general construction and positioning of the sparger device 100. In practice, the sparger device 100 may have a horizontal extent that spans nearly the entire inner diameter of the bag 20 and / or vessel 12 (see, e.g., Figure 3 Additionally, it is contemplated that the injector device 100 may be attached elsewhere on the bottom of the bag (not necessarily adjacent the perimeter of the bottom of the bag 20 ) or even to a port in the sidewall of the bag 20 .

[0033] Now go to Figures 4 to 6 , which shows an ejector device 100 according to one embodiment of the present invention. Figures 4 to 6 As shown in FIG, the injector device 100 is generally T-shaped and includes a first tube (injection tube 102) and a second tube (supply tube 104) connected to the injection tube 102 and oriented substantially perpendicularly thereto. The injection tube 102 has a central passage 106 and a plurality of radial injection holes 108 or orifices along the length of the tube 102 and in fluid communication with the central passage 106. In an embodiment, the injection holes 108 are spaced equidistantly from one another along the length of the tube 102; however, in some embodiments, the injection holes 108 may be irregularly spaced along the tube 102. The injection tube 102 also includes a central inlet opening 110 in the underside of the tube 102 at a midpoint along the length of the tube 102. In an embodiment, the inlet opening 110 is positioned approximately 180 degrees from the injection holes 108 on the top of the tube 102.

[0034] As in Figure 5 and Figure 6 As best shown in FIG, the supply tube 104 likewise includes a central supply passage 112 that is in fluid communication with the central passage 106 of the injection tube 102 via an inlet opening 110 in the injection tube 102. In one embodiment, the central passage 112 may have a large diameter portion 114, a reduced diameter portion 116, and a shoulder portion 118 that forms a transition between the large diameter portion 114 and the reduced diameter portion 116. Figure 6As shown in FIG, the supply tube 104 defines a central hub having a generally T-shaped sleeve 120 that surrounds the injection tube 102 and serves to connect the injection tube 102 to the supply tube 104. In an embodiment, the reduced diameter portion 116 of the central passage 112 of the supply tube 104 and the central passage 102 may have an inner diameter between about 0 inches and about 0.25 inches. In an embodiment, the injection orifice may have a diameter between about 0 inches and about 0.25 inches. In another embodiment, the injection orifice may have a diameter between about 0 inches and about 0.125 inches or between about 0 inches and about 0.0625 inches. In an embodiment, the supply tube 104 may have a generally uniform outer diameter of about 0.25 to about 0.5 inches.

[0035] Although the spray tube 102 has been described above as being generally linear in shape, it is contemplated that the spray tube 102 may have nearly any shape so long as the spray tube 102 is a unitary component. In particular, the spray tube 102 may be generally annular or arcuate in shape such that the spray tube 102 extends around the impeller adjacent the inner periphery of the flexible bag 20.

[0036] As indicated above, the injector device 100 thus has a two-piece construction, namely, a unitary injector tube 102 having a central inlet opening 110 and a supply tube 104 in fluid communication with the injector tube 102 via the central inlet opening 110. It is contemplated that the injector tube 102 and the supply tube may be manufactured from a variety of materials, such as, for example, polypropylene. In embodiments, the supply tube 104 is manufactured with a certain wall thickness and / or from a single material, such that the supply tube 104 is relatively stiff and robust. In embodiments, the supply tube 104 may be formed by overmolding around the injector tube 102, as described below.

[0037] In particular, refer to Figure 8 The ejector device 100 can be manufactured by first forming an ejector tube 102 having a central inlet opening 110 and an ejection hole 108 located at a predetermined position spaced from the midpoint of the tube 102. For example, this can be performed using various molding processes, however, the present invention is not limited in this regard. In particular, it is contemplated that the ejector tube 102 can be manufactured using various techniques such as, for example, molding or additive manufacturing techniques.

[0038] Once the injection tube 102 is formed, the injection tube 102 is then positioned in a mold 140 having a mold area 142 that corresponds in shape / configuration to the shape / configuration of the central hub to be formed. Figure 8As shown in , the mold 140 has a core pin 150; when the injection tube is positioned in the mold 140, the core pin 150 is inserted into the inlet opening 110 in the injection tube 102. The core pin 150 has a diameter that is equal to or slightly larger than the diameter of the inlet opening 110 in the injection tube 102. In an embodiment, the core pin 150 may have a diameter that is approximately 0 to about 0.01 inches and more particularly about 0 to about 0.004 and even more particularly about 0.002 to about 0.004 inches larger than the diameter of the inlet opening 110, so that when inserted into the inlet opening 110, the core pin 150 forms an interference fit with the injection tube 102. In an embodiment, the core pin 150 may have a diameter that is slightly (e.g., 0.01 inches) smaller than the diameter of the inlet opening, which will still prevent inflow of the injected material due to the nominal void space. The core pin 150 also has a tapered tip 152 that facilitates insertion of the core pin 150 into the inlet opening 110. As Figure 8 As shown in FIG, the core pin 150 has a large diameter portion 154, a reduced diameter portion 156, and a shoulder portion 158 that forms a transition between the larger diameter portion 154 and the reduced diameter portion 156.

[0039] After the injection tube 102 is received on the core pin 150 and positioned in the mold 140, material flows into the mold area 142 around the core pin 150 and the injection tube 102 to form the central hub (i.e., the sleeve 120 and the supply tube 104). The injection device 100 is then removed from the mold 140. The removal of the core pin 150 forms the central passage 112 of the supply tube 104. As will be appreciated, receiving the core pin 150 in the inlet opening 110 of the injection tube 102 ensures that the holes on opposite sides of the injection tube 102 are equally spaced from the midpoint of the injection tube 102. In addition, because the core pin 150 forms an interference fit with the injection tube 102 when inserted into the opening 110, material is prevented from leaking through the opening 110 into the injection tube 102, which could create a restriction within the passage 106 (which could result in a pressure drop during use).

[0040] Once the injection device is removed from the mold (or, in some embodiments, prior to overmolding the central hub), the opposite distal end of the injection tube 102 may be plugged or capped. Figure 9 The figure shows a cover 200 for the spray pipe 102 according to one embodiment of the present invention. Figure 9 As shown in FIG, the cap 200 includes a main body portion 202 having a cylindrical recess 204 that generally corresponds in diameter to the outer diameter of the injection tube 102, which allows the recess 204 to create an interference / press fit with the injection tube 102. The cap 200 also includes a central through-bore or hole 206 that is generally aligned with the longitudinal axis of the injection tube 102 when the cap is received on the distal end of the injection tube 102. Figure 9 , the cover 200 may be rounded in shape and / or have rounded corners to minimize or prevent damage or scratching of system components (such as the bag membrane, impeller, sensor, etc.). In an embodiment, the through bore 206 has a diameter that is substantially the same as the diameter of the injection hole 108. The through bore 206 in the cover 206 allows the injection gas to exit axially through the cover 206 at the distal end of the injection tube 102. This effectively eliminates any dead space at the end of the injection tube 102 beyond the last injection hole 108.

[0041] Figure 10 FIG. 3 shows a cover 300 according to another embodiment of the present invention. Figure 10 As shown in FIG, the cover 300 is generally similar in shape and construction to Figure 9 The cover 200 includes a main body portion 302 having a cylindrical recess 304 that generally corresponds in diameter to the outer diameter of the injection tube 102, which allows the recess 304 to create an interference / press fit with the injection tube 102. The cover 300 also includes a through bore 306. The through bore 306 is shaped so that the jet gas exits the cover in a direction generally orthogonal to the longitudinal axis of the injection tube 102 (i.e., generally parallel to the direction in which the jet gas exits through the injection hole 108). For example, Figure 10 As shown in , the through bore includes a first leg that is generally aligned with the longitudinal axis of the injection tube 102 when the cap 300 is received on the distal end of the injection tube 102, and a second leg that forms a substantially 90 degree angle with the first leg. Figure 10 , the cover 300 may likewise be rounded in shape and / or have rounded corners to minimize or prevent damage or scratching of system components such as the bag membrane, impeller, sensor, etc. In an embodiment, the through bore 306 has a diameter substantially the same as the diameter of the injection hole 108. Similar to the cover 200, the through bore 306 in the cover 300 effectively eliminates any dead space at the end of the injection tube 102 beyond the last injection hole 108.

[0042] Assumption Figure 9 and Figure 10 The cap 200, 300 may be coupled to the distal end of the spray tube 102 by a variety of means including, but not limited to, press fit, adhesives, welding, and the like.

[0043] Finally go to Figure 11In an embodiment, rather than utilizing a cap, the injection tube 102 may be manufactured with a narrowed distal end 400. Specifically, the distal end of the injection tube 102 may be formed as a point with an axial opening 402 therein that generally corresponds in diameter to the diameter of the injection orifice 108. Similar to the caps 200, 300 and their apertures, the opening 402 allows the injection gas to exit at the distal end of the injection tube 102, thereby preventing any dead space at the end of the injection tube 102 beyond the last injection orifice 108.

[0044] As mentioned above, the sparger device 100 is intended to be connected to a fluid port on the bottom of the flexible bag 20 of the bioreactor / bioprocessing system. The fluid port, and therefore the sparger device 100, is connected to a fluid (i.e., sparge gas) supply source for use during the sparging operation of the bioreactor system. As indicated above, due to the two-piece construction of the device and the configuration of the central hub and supply tube 104, the sparger device 100 is robust and quite stiff. As a result, the sparger device 100 is far less prone to movement within the bag, thereby minimizing the likelihood that the sparger device 100 will contact the impeller, sensor, bag membrane, etc. In addition, providing a hole or opening on the distal end of the sparger device 100 (via a cap or narrowed distal end) eliminates dead space in the sparger tube 102 beyond the farthest sparge hole.

[0045] The construction of the injector device 100 and the manufacturing process for the injector device 100 also facilitate accurate and repeatable injection hole location. In particular, when received in the central inlet opening 110 in the injection tube 102, the core pin 150 accurately positions the supply channel 112 of the supply tube 10 to be equidistant from the supply channel 112 and the injection holes 108 on either side of the inlet opening 110. In addition, by utilizing an integral (i.e., single-piece) injection tube 102, the assembly and alignment of the injection tube 102 (and its injection holes 108) relative to the supply tube 104 are simplified. Due to this accurate injection hole positioning, the possibility of reverse flow of trapped cell debris inside the injection tube is minimized. The use of the core pin 150 as discussed above also provides a reliable hole seal, thereby preventing mold material from leaking into the injection tube 102, which can create a restriction that causes a pressure drop during injection.

[0046] The sparger device 100 of the present invention and the manufacturing method for the sparger device 100 significantly minimize the possibility of cell accumulation within the sparger and are less prone to deflection. As discussed above, the manufacturing method described herein achieves more repeatable hole positioning and is simpler and less expensive than existing methods. The sparger device of the present invention disclosed above can be used to inject gas into a liquid for a variety of purposes, including, for example, controlling the amount of dissolved gas (e.g., oxygen, nitrogen, carbon dioxide) in the liquid and / or for carbon dioxide stripping.

[0047] In an embodiment, an injector device is provided. The injector device includes: a jet tube having opposite distal ends, an inlet opening, and a plurality of jet holes along the longitudinal extent of the jet tube between the opposite distal ends; and a central hub coupled to the jet tube at a point intermediate the opposite distal ends of the jet tube, the central hub having a fluid passage in fluid communication with the jet tube via the inlet opening. In an embodiment, the central hub is overmolded around the jet tube. In an embodiment, the plurality of jet holes are located in the top of the jet tube, and the inlet opening is located in the bottom of the jet tube. In an embodiment, the injector device further includes a cap on at least one of the opposite distal ends of the jet tube, the cap having a through-bore in fluid communication with the central passage of the jet tube. In an embodiment, the through-bore is an axial through-bore oriented to direct jet gas from the through-bore in a direction generally perpendicular to the jet gas exiting through the plurality of jet holes. In an embodiment, the through-bore is oriented to direct jet gas from the through-bore in a direction generally parallel to the jet gas exiting through the plurality of jet holes. In an embodiment, the through-bore comprises an angle of approximately 90 degrees. In an embodiment, the opposite distal ends of the injection tube narrow to a point, and the opposite distal ends each include an axial opening for passage of the injection gas.

[0048] In another embodiment, a method of manufacturing an injector device is provided. The method includes the following steps: providing a tube having opposite distal ends and an inlet opening in a sidewall of a first tube between the opposite distal ends; inserting a pin into the inlet opening; overmolding around the pin and tube to form a central hub; and removing the pin to form a supply passage within the central hub, the supply passage being in fluid communication with the interior of the tube via the inlet opening. In one embodiment, the tube includes a plurality of radial holes along the longitudinal extent of the tube. In one embodiment, the pin has a tapered tip. In one embodiment, the pin has an outer diameter that is larger than the diameter of the inlet opening of the tube so as to form an interference fit when the pin is inserted into the inlet opening. In one embodiment, the method further includes inserting a cap over each of the opposite distal ends of the tube. In one embodiment, the cap includes an axial bore oriented to direct the jet gas from the axial bore in a direction generally perpendicular to the jet gas exiting through the plurality of radial holes. In one embodiment, the cap includes a bore oriented to direct the jet gas from the bore in a direction generally parallel to the jet gas exiting through the plurality of radial holes. In an embodiment, the cover is attached to the tube by at least one of a press fit, an adhesive, and / or welding.

[0049] In yet another embodiment, a bioprocessing system is provided. The bioprocessing system includes: a vessel; a flexible bioprocessing bag positionable within the vessel; and an sparger device coupled to a fluid port in the flexible bioprocessing bag, the sparger device including a sparger tube and a central hub, the sparger tube having opposite distal ends, an inlet opening, and a plurality of sparger holes along the longitudinal extent of the sparger tube between the opposite distal ends, the central hub coupled to the sparger tube at a point intermediate the opposite distal ends of the sparger tube, the central hub having a fluid passage in fluid communication with the sparger tube via the inlet opening. In an embodiment, the sparger device is T-shaped. In an embodiment, the sparger device further includes a cap on at least one of the opposite distal ends of the sparger tube, the cap having a through-bore in fluid communication with the central passage of the sparger tube. In an embodiment, the through-bore is an axial through-bore oriented to direct sparger gas from the through-bore in a direction generally perpendicular to the sparger gas exiting through the plurality of sparger holes. In an embodiment, the through-bore is oriented to direct sparger gas from the through-bore in a direction generally parallel to the sparger gas exiting through the plurality of sparger holes.

[0050] In yet another embodiment, an injector device is provided. The injector device includes: at least one injector tube having a distal end and a plurality of injector holes along the longitudinal extent of the injector tube; a hub coupled to the injector tube, the hub having a fluid passageway in fluid communication with a central passageway of the injector tube for providing gas to the injector tube; and a cap on the distal end of the injector tube, the cap having a through-bore in fluid communication with the central passageway of the injector tube. In an embodiment, the through-bore is an axial through-bore oriented to direct the injected gas out of the through-bore in a direction generally perpendicular to the injected gas exiting through the plurality of injector holes. In an embodiment, the through-bore is oriented to direct the injected gas out of the through-bore in a direction generally parallel to the injected gas exiting through the plurality of injector holes.

[0051] As used herein, an element or step recited in the singular and beginning with the word "one" or "a kind of" should be understood as not excluding a plurality of said elements or steps, unless such exclusion is explicitly stated. In addition, reference to "one embodiment" of the present invention is not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the described features. In addition, unless explicitly stated to the contrary, an embodiment that "comprises," "includes," or "has" an element or multiple elements with a particular property may include additional such elements that do not have that property.

[0052] This written description uses examples to disclose several embodiments of the invention, including the best mode, and also to enable one of ordinary skill in the art to practice the embodiments of the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims and may include other examples that occur to one of ordinary skill in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal language of the claims.

Claims

1. An ejector device (100), comprising: at least one integral spray tube (102) having a constant outer diameter defining a central passageway having a distal end; a plurality of spray holes (108) along a longitudinal extent of the spray tube (102); and an inlet opening formed in the central passageway about the longitudinal extent of the spray tube; as well as an integral hub coupled to the jet tube but leaving the jet tube intact, the hub having a central supply passage in fluid communication with the central passage of the jet tube to provide gas to the jet tube, wherein the central supply passage has a larger diameter portion configured to engage a core pin and a smaller diameter portion having a smaller diameter substantially the same as the diameter of the central passage of the jet tube, the larger diameter portion and the smaller diameter portion being in fluid communication with the inlet opening in the jet tube, wherein the smaller diameter portion is proximate the inlet opening and the larger diameter portion is distal to the inlet opening, wherein the smaller diameter portion extends directly to the inlet opening without extending into the central passage; as well as a cap on the distal end of the jet tube, wherein the cap is a separate and physical element from the jet tube and has a cap body formed of a solid material, the cap body having a recess, an outlet opening, and a through bore, the recess having a uniform diameter throughout the cap body and outwardly extending sidewalls, the uniform diameter corresponding in diameter to the constant outer diameter of the jet tube for receiving the distal end of the jet tube therein, the outwardly extending sidewalls defining the recess formed therebetween, each of the outwardly extending sidewalls advancing along an outer surface of the constant outer diameter of the jet tube, the recess of the cap surrounding the distal end, and the outwardly extending sidewalls surrounding a portion of the outer surface of the constant outer diameter of the jet tube around the distal end, the outlet opening being formed on an outer surface of the cap body, the through bore extending directly from the outlet opening through the cap body and to the distal end of the constant outer diameter of the jet tube, wherein the through bore is in fluid communication with the central passage of the jet tube, and wherein the outlet opening is formed on a portion of the cap body directly adjacent the distal end of the jet tube.

2. The ejector device (100) according to claim 1, wherein: The through-bore is an axial through-bore oriented to direct the injected gas out of the through-bore in a direction generally perpendicular to the injected gas exiting through the plurality of injection holes.

3. The ejector device (100) of claim 1, wherein: The through bore is oriented to direct the injected gas out of the through bore in a direction generally parallel to the injected gas exiting through the plurality of injection holes.

4. The ejector device (100) of claim 1, wherein the hub further comprises: a first portion extending longitudinally with the central passage of the injection pipe and a second portion arranged perpendicular to the first portion and the central passage, the first portion having an opening extending from a first end to a second end thereof to receive the injection pipe therethrough, the first portion forming a sleeve surrounding a portion of the injection pipe and through which the central passage extends, the second portion having an opening therethrough, the opening extending into the first portion and terminating in the inlet opening, the inlet opening providing an inlet into the central passage of the injection pipe, the opening in the second portion defining the central supply passage in fluid communication with the central passage of the injection pipe.

5. The ejector device (100) of claim 1, wherein: The integral hub (104) is integrally formed around the injection tube (102).

6. The ejector device (100) of claim 1, wherein: The plurality of spray holes (108) are located in the top of the integral spray pipe (102); and The inlet opening (110) is located in the bottom of the injection pipe (102).

7. The ejector device (100) according to claim 3, wherein: The through bore includes an angle of approximately 90 degrees.

8. The ejector device (100) according to claim 1, wherein the ejector pipe further comprises: The other distal end of the integral injection pipe (102) opposite to the distal end with the cap thereon is narrowed to a point and includes an axial opening (402) for passing injection gas.

Images