Impeller guard

Abstract

Disclosed are guard devices for an impeller, methods of using the guard devices, impeller assemblies including the guard devices mounted to the impeller, impeller systems, and bioreactor systems including the impeller systems.

Description

TECHNICAL FIELD

[0001] The present invention relates to an impeller guard. BACKGROUND

[0002] Preparation of fluids, particularly solutions and suspensions in the pharmaceutical and biopharmaceutical industries, often involves thorough mixing to provide a desired distribution of ingredients in the product. Many mixing operations are performed in bioreactor bags with mixing impellers mounted near the bottom of the vessel. A variety of impellers with different sized impeller hubs, impeller blades, and / or blade configurations are available for mixing.

[0003] However, damage to the bioreactor bag compromises the sterility of the fluid in the bag, resulting in loss of valuable fluid. SUMMARY

[0004] The present invention at least alleviates some of the shortcomings of the prior art. These and other advantages of the present invention will become apparent from the following description.

[0005] One aspect of the present invention provides a guard for an impeller, the impeller having at least a first blade and a second blade, each of the first blade and the second blade having a front blade face and a back blade face, an upper edge, an outer edge, an upper outer corner, a lower edge, and an inner edge, the upper edge contacting the outer edge at the upper outer corner, the guard comprising: (A) an upper annular ring having an upper annular ring horizontal axis and a first inner diameter, the upper annular ring having an upper surface and a lower surface, wherein the lower surface comprises at least: a first blade receiving slot for receiving the upper outer corner of the first blade, the first blade receiving slot having a first side and a second side; a second blade receiving slot for receiving the upper outer corner of the second blade, the second blade receiving slot having a first side and a second side; (B) a lower annular ring having a lower annular ring horizontal axis and a second inner diameter, wherein the second inner diameter is smaller than the first inner diameter; (C) at least a first support member and a second support member, each of the first support member and the second support member being attached to the upper annular ring and the lower annular ring, each of the first support member and the second support member being disposed vertically between the upper annular ring and the lower annular ring and perpendicular to the upper annular ring horizontal axis and the lower annular ring horizontal axis, (1) the first support member having a first support member front wall, a first support member back wall, a first support member outer side wall, and a first support member inner side wall, the first support member inner side wall being in contact with the lower annular ring, the first support member front wall or the first support member back wall being disposed to face the front blade face or the back blade face of the first blade and forming the second side of the first blade receiving slot; (a) the first support member having: a vertical slot for receiving a portion of the inner edge of the first blade; and a gripping portion for lockably receiving a portion of the lower edge of the first blade; (2) the second support member having a second support member front wall, a second support member back wall, a second support member outer side wall, and a second support member inner side wall, the second support member inner side wall being in contact with the lower annular ring, the second support member front wall or the second support member back wall being disposed to face the front blade face or the back blade face of the second blade and forming the second side of the second blade receiving slot; (b) the second support member having: a vertical slot for receiving a portion of the inner edge of the second blade; and a gripping portion for lockably receiving a portion of the lower edge of the second blade.

[0006] In another aspect, there is provided an impeller assembly comprising: an impeller having at least a first blade and a second blade, each of the first blade and the second blade having a front blade face and a back blade face, an upper edge, an outer edge, an upper outer corner, a lower edge, and an inner edge, the upper edge contacting the outer edge at the upper outer corner; and a guard according to one aspect of the present invention mounted on the impeller.

[0007] In yet another aspect, a method of installing an aspect of a guard to an impeller is provided, the method comprising: positioning an inner edge of a blade of the impeller in a vertical slot of a corresponding support member; positioning an upper outer corner of the blade of the impeller in a corresponding blade-receiving slot; and positioning a lower edge of the blade of the impeller in a corresponding gripping portion of the support member.

[0008] In yet another aspect, an impeller system is provided, comprising an aspect of an impeller assembly, a pin, and a seat fitting.

[0009] Another aspect relates to a biological container system comprising: (a) a biological container comprising an enclosed container having an interior volume adapted to contain a fluid, the container comprising a bottom wall, a top wall, at least one side wall connected to the top wall and the bottom wall; and at least an inlet port and a drain port, wherein the biological container further comprises: (b) an aspect of an impeller system, wherein the impeller is mounted to an inner surface of the bottom wall of the biological container. BRIEF DESCRIPTION OF DRAWINGS

[0010] Figure 1A and 1B are top and bottom perspective views, respectively, of a guard for an impeller according to an aspect of the present invention.

[0011] Figure 2A and 2B are top and bottom perspective views, respectively, Figure 1A of an aspect of the guard shown in FIG. 1.

[0012] Figure 3 is a side view of an aspect of the guard shown in FIG. 1. Figure 1A

[0013] Figure 4A and 4B are top and bottom perspective views, respectively, of an impeller suitable for use with a guard according to an aspect of the present invention.

[0014] Figure 5A and 5B are top and bottom perspective views, respectively, of an impeller assembly according to an aspect of the present invention, comprising an aspect of the guard shown in FIG. 1 mounted to an impeller shown in FIG. 4. Figure 1A

[0015] Figure 6A is a perspective view of an impeller system according to an aspect of the present invention, comprising Figure 5A the impeller assembly shown in FIG. 4, wherein the impeller has a central opening and a pin and seat fitting, the pin passing through the central opening into the seat fitting for mounting the impeller system to a biological container comprising an enclosed container having an interior volume for containing a fluid. Figure 6B is a perspective view of a pin,​​Figure 6C is a top perspective view of a hub assembly.

[0016] Figure 7A is a perspective view of an impeller system according to another aspect of the present application, including an impeller assembly (guard removed for ease of viewing) including a base including bearings in a frame and a pin and hub assembly, the pin passing through a central opening into the hub assembly for mounting the impeller system to a bioreactor, the bioreactor including an enclosed container having an interior volume for containing a fluid. Figure 7B is Figure 7A is a cross-sectional view of the impeller system shown.

[0017] Figure 8 is a side view of a bioreactor system according to an aspect of the present application, including a bioreactor including an enclosed container having an interior volume for containing a fluid, further including Figure 6A is an aspect of the impeller system shown, with the impeller mounted on the bioreactor. DETAILED DESCRIPTION

[0018] One aspect of the present invention provides a guard for an impeller, the impeller having at least a first blade and a second blade, each of the first blade and the second blade having a front blade face and a back blade face, an upper edge, an outer edge, an upper outer corner, a lower edge, and an inner edge, the upper edge contacting the outer edge at the upper outer corner, the guard comprising: (A) an upper annular ring having an upper annular ring horizontal axis and a first inner diameter, the upper annular ring having an upper surface and a lower surface, wherein the lower surface comprises at least: a first blade receiving slot for receiving the upper outer corner of the first blade, the first blade receiving slot having a first side and a second side; a second blade receiving slot for receiving the upper outer corner of the second blade, the second blade receiving slot having a first side and a second side; (B) a lower annular ring having a lower annular ring horizontal axis and a second inner diameter, wherein the second inner diameter is smaller than the first inner diameter; (C) at least a first support member and a second support member, each of the first support member and the second support member attached to the upper annular ring and the lower annular ring, each of the first support member and the second support member disposed vertically between the upper annular ring and the lower annular ring and perpendicular to the upper annular ring horizontal axis and the lower annular ring horizontal axis, (1) the first support member having a first support member front wall, a first support member back wall, a first support member outer side wall, and a first support member inner side wall, the first support member inner side wall in contact with the lower annular ring, the first support member front wall or the first support member back wall disposed to face the front blade face or the back blade face of the first blade and form the second side of the first blade receiving slot; (a) the first support member having: a vertical slot for receiving a portion of the inner edge of the first blade; and a gripping portion for lockably receiving a portion of the lower edge of the first blade; (2) the second support member having a second support member front wall, a second support member back wall, a second support member outer side wall, and a second support member inner side wall, the second support member inner side wall in contact with the lower annular ring, the second support member front wall or the second support member back wall disposed to face the front blade face or the back blade face of the second blade and form the second side of the second blade receiving slot; (b) the second support member having: a vertical slot for receiving a portion of the inner edge of the second blade; and a gripping portion for lockably receiving a portion of the lower edge of the second blade.

[0019] In some aspects of the guard, the lower surface of the upper annular ring comprises: a first protrusion spaced apart from the front blade face or the back blade face of the first blade by a distance and forming the first side of the first blade receiving slot; and a second protrusion spaced apart from the front blade face or the back blade face of the second blade by a distance and forming the first side of the second blade receiving slot.

[0020] Alternatively or additionally, in some aspects, the first support member inner sidewall includes a first support member extension forming a portion of the vertical slot for receiving a portion of the inner edge of the first blade, and the second support member inner sidewall includes a second support member extension forming a portion of the vertical slot for receiving a portion of the inner edge of the second blade.

[0021] Alternatively or additionally, in some aspects, the first support member has a first support member bottom end including the said grip for lockably receiving a portion of the lower edge of the first blade, and the second support member has a second support member bottom end including the said grip for lockably receiving a portion of the lower edge of the second blade.

[0022] In some aspects, the grip of the first support member and the grip of the second support member each include a hook portion.

[0023] In another aspect, there is provided an impeller assembly comprising: an impeller having at least a first blade and a second blade, each of the first blade and the second blade having a front blade face and a back blade face, an upper edge, an outer edge, an upper outer corner, a lower edge, and an inner edge, the upper edge contacting the outer edge at the upper outer corner; and a guard for the impeller, the guard comprising: (A) an upper ring having an upper ring horizontal axis and a first inner diameter, the upper ring having an upper surface and a lower surface, wherein the lower surface comprises at least: a first blade receiving slot for receiving the upper outer corner of the first blade, the first blade receiving slot having a first side and a second side; a second blade receiving slot for receiving the upper outer corner of the second blade, the second blade receiving slot having a first side and a second side; (B) a lower ring having a lower ring horizontal axis and a second inner diameter, wherein the second inner diameter is smaller than the first inner diameter; (C) at least a first support member and a second support member, each of the first support member and the second support member being attached to the upper ring and the lower ring, each of the first support member and the second support member being disposed vertically between the upper ring and the lower ring and perpendicular to the upper ring horizontal axis and the lower ring horizontal axis, (1) the first support member having a first support member front wall, a first support member back wall, a first support member outer side wall, and a first support member inner side wall, the first support member inner side wall being in contact with the lower ring, the first support member front wall or the first support member back wall being disposed to face the front blade face or the back blade face of the first blade and forming the second side of the first blade receiving slot; (a) the first support member having: a vertical slot for receiving a portion of the inner edge of the first blade; and a gripping portion for lockably receiving a portion of the lower edge of the first blade; (2) the second support member having a second support member front wall, a second support member back wall, a second support member outer side wall, and a second support member inner side wall, the second support member inner side wall being in contact with the lower ring, the second support member front wall or the second support member back wall being disposed to face the front blade face or the back blade face of the second blade and forming the second side of the second blade receiving slot; (b) the second support member having: a vertical slot for receiving a portion of the inner edge of the second blade; and a gripping portion for lockably receiving a portion of the lower edge of the second blade, the guard being mounted to the impeller.

[0024] In yet another aspect, a impeller system is provided, comprising one aspect of an impeller assembly comprising: an impeller having at least a first blade and a second blade, each of the first blade and the second blade having a front blade face and a back blade face, an upper edge, an outer edge, an upper outer corner, a lower edge, and an inner edge, the upper edge contacting the outer edge at the upper outer corner; and a guard for the impeller, the guard comprising: (A) an upper ring having an upper ring horizontal axis and a first inner diameter, the upper ring having an upper surface and a lower surface, wherein the lower surface comprises at least: a first blade receiving slot for receiving the upper outer corner of the first blade, the first blade receiving slot having a first side and a second side; a second blade receiving slot for receiving the upper outer corner of the second blade, the second blade receiving slot having a first side and a second side; (B) a lower ring having a lower ring horizontal axis and a second inner diameter, wherein the second inner diameter is smaller than the first inner diameter; (C) at least a first support member and a second support member, each of the first support member and the second support member attached to the upper ring and the lower ring, each of the first support member and the second support member disposed vertically between the upper ring and the lower ring and perpendicular to the upper ring horizontal axis and the lower ring horizontal axis, (1) the first support member having a first support member front wall, a first support member back wall, a first support member outer side wall, and a first support member inner side wall, the first support member inner side wall in contact with the lower ring, the first support member front wall or the first support member back wall disposed to face the front blade face or the back blade face of the first blade and form the second side of the first blade receiving slot; (a) the first support member having: a vertical slot for receiving a portion of the inner edge of the first blade; and a gripping portion for lockably receiving a portion of the lower edge of the first blade; (2) the second support member having a second support member front wall, a second support member back wall, a second support member outer side wall, and a second support member inner side wall, the second support member inner side wall in contact with the lower ring, the second support member front wall or the second support member back wall disposed to face the front blade face or the back blade face of the second blade and form the second side of the second blade receiving slot; (b) the second support member having: a vertical slot for receiving a portion of the inner edge of the second blade; and a gripping portion for lockably receiving a portion of the lower edge of the second blade, the guard mounted to the impeller; a pin; and a seat fitting.

[0025] In another aspect, there is provided a biological container system comprising: (a) a biological container comprising a closed container having an interior volume adapted to contain a fluid, the container comprising a bottom wall, a top wall, at least one side wall connected to the top wall and the bottom wall; and at least an inlet port and a drain port, wherein the biological container further comprises: (b) an impeller system comprising an impeller assembly comprising: an impeller having at least a first blade and a second blade, each of the first blade and the second blade having a leading blade face and a trailing blade face, an upper edge, an outer edge, an upper outer corner, a lower edge, and an inner edge, the upper edge contacting the outer edge at the upper outer corner; and a guard for the impeller, the guard comprising: (A) an upper annular ring having an upper annular ring horizontal axis and a first inner diameter, the upper annular ring having an upper surface and a lower surface, wherein the lower surface comprises at least: a first blade receiving slot for receiving the upper outer corner of the first blade, the first blade receiving slot having a first side and a second side; a second blade receiving slot for receiving the upper outer corner of the second blade, the second blade receiving slot having a first side and a second side; (B) a lower annular ring having a lower annular ring horizontal axis and a second inner diameter, wherein the second inner diameter is smaller than the first inner diameter; (C) at least a first support member and a second support member, each of the first support member and the second support member attached to the upper annular ring and the lower annular ring, each of the first support member and the second support member disposed vertically between the upper annular ring and the lower annular ring and perpendicular to the upper annular ring horizontal axis and the lower annular ring horizontal axis, (1) the first support member having a first support member front wall, a first support member back wall, a first support member outer side wall, and a first support member inner side wall, the first support member inner side wall in contact with the lower annular ring, the first support member front wall or the first support member back wall disposed to face the leading blade face or the trailing blade face of the first blade and form the second side of the first blade receiving slot; (a) the first support member having: a vertical slot for receiving a portion of the inner edge of the first blade; and a gripping portion for lockably receiving a portion of the lower edge of the first blade; (2) the second support member having a second support member front wall, a second support member back wall, a second support member outer side wall, and a second support member inner side wall, the second support member inner side wall in contact with the lower annular ring, the second support member front wall or the second support member back wall disposed to face the leading blade face or the trailing blade face of the second blade and form the second side of the second blade receiving slot; (b) the second support member having: a vertical slot for receiving a portion of the inner edge of the second blade; and a gripping portion for lockably receiving a portion of the lower edge of the second blade, the guard mounted to the impeller; a pin; and a seat fitting; wherein the impeller is mounted to an inner surface of the bottom wall of the biological container.

[0026] In another aspect, a method is provided for mounting one aspect of a protective device to an impeller, the method comprising: positioning the inner edge of the impeller blade in a vertical groove of a corresponding support member; positioning the upper outer corner of the impeller blade in a corresponding blade receiving groove; and positioning the lower edge of the impeller blade in a gripping portion of a corresponding support member.

[0027] Various aspects of the present invention are particularly applicable to closed and / or sterile systems.

[0028] Each component of the invention will now be described in more detail below, wherein similar components have similar reference numerals.

[0029] Although a suitable impeller can have a variety of configurations and any number of blades, Figure 4A and 4B An exemplary impeller 1000 is shown, having four blades attached to a hub 1100 having a central opening 1090: a first blade 1001, a second blade 1002, a third blade 1003, and a fourth blade 1004, each blade having a front blade surface and a rear blade surface 1001A, 1001B; 1002A, 1002B; 1003A, 1003C; and 1004A, 1004B. Each blade has an upper edge 1011, 1012, 1013, 1014, an outer edge 1021, 1022, 1023, 1024, an upper outer corner 1031, 1032, 1033, 1034, a lower edge 1041, 1042, 1043, 1044, and an inner edge 1051, 1052, 1053, 1054, with the upper edge contacting the outer edge at the upper outer corner.

[0030] In a preferred aspect, the impeller is a magnetic impeller; in some aspects, the impeller is a suspended magnetic impeller. If desired, at some point, a removable metal plate can be placed in contact with the bottom surface of the magnetic impeller to provide protection, or at least minimize the potential influence of the magnetic field on nearby devices or components, even if this cannot be eliminated.

[0031] use Figure 1A , 1B Referring to aspects shown in 2A, 2B and 3, the impeller has at least a first blade and a second blade, each of the first blade and the second blade having a front blade surface and a rear blade surface, an upper edge, an outer edge, an upper outer corner, a lower edge and an inner edge, the upper edge contacting the outer edge at the upper outer corner. Figure 4A and 4B The impeller shown in the diagram), the protective device 500 for the impeller includes an upper annular ring 100, the upper annular ring having an upper annular ring horizontal axis HA1 ( Figure 3) and a first inner diameter 175, the upper annular ring having an upper surface 101 and a lower surface 102, wherein the lower surface comprises at least: a first vane receiving slot 371 for receiving an upper outer corner of a first vane (see Figure 5A ), the first vane receiving slot having first and second sides 371A, 371B (see Figure 2B ); and a second vane receiving slot 372 for receiving an upper outer corner of a second vane, the second vane receiving slot having first and second sides 372A, 372B. In the illustrated aspect, the impeller includes four vanes, and the guard includes third and fourth vane receiving slots 373, 374 for receiving respective upper outer corners of third and fourth vanes, the third and fourth vane receiving slots having first and second sides 373A, 373B, 374A, 374B, respectively.

[0032] In the illustrated aspect, the lower annular ring 200 has a lower annular ring horizontal axis HA2 Figure 3 ) and a second inner diameter 275, wherein the second inner diameter 275 is less than the first inner diameter 175; at least first and second support members 301, 302, each attached to the upper annular ring and the lower annular ring, each of the first and second support members being disposed between the upper annular ring and the lower annular ring along a vertical axis VA and perpendicular to the upper annular ring horizontal axis and the lower annular ring horizontal axis, the first support member 301 having a first support member front wall 301A, a first support member rear wall 301B, a first support member outer side wall 301C, and a first support member inner side wall 301D, the first support member inner side wall contacting the lower annular ring, the first support member front wall or the first support member rear wall being disposed to face a front vane face or a rear vane face of the first vane and form the second side 371B of the first vane receiving slot 371; (a) the first support member having a vertical slot 361 for receiving a portion of an inner edge of the first vane, and a grip 381 for lockably receiving a portion of a lower edge of the first vane (see Figure 5A and 5B); the second support member 302 has a second support member front wall 302A, a second support member back wall 302B, a second support member outer wall 302C, and a second support member inner wall 302D that contacts the lower annular ring, the second support member front wall or the second support member back wall being arranged to face the front or back vane face of the second vane and form a second side 372B of the second vane receiving slot 372; (b) the second support member has a vertical slot 362 for receiving a portion of the inner edge of the second vane, and a grip 382 for lockably receiving a portion of the lower edge of the second vane. In the illustrated aspect, the impeller includes four vanes, and the guard includes third and fourth support members 303, 304 having front, back, outer, and inner walls 303A, 303B, 303C, 303D, 304A, 304B, 304C, 304D, vertical slots 363, 364, and grips 383, 384, respectively.

[0033] If desired (see Figure 2B ), the lower surface 102 of the upper annular ring can include: a first protrusion 351 (shown as a double protrusion if increased robustness is desired) that is spaced a distance from the front or back vane face of the first vane and forms a first side 371A of the first vane receiving slot 371; and a second protrusion 352 (shown as a double protrusion if increased robustness is desired) that is spaced a distance from the front or back vane face of the second vane and forms a first side 372A of the second vane receiving slot 372. The illustrated aspect also shows third and fourth protrusions 353, 354 (each shown as a double protrusion if increased robustness is desired) that form first sides 353A, 354A of respective third and fourth vane receiving slots 373, 374. If desired, the upper corners of the protrusions to the first sides of the vane receiving slots can be angled downward (see Figure 1B 351A, 352A, 353A, and 354A) to facilitate guiding the upper outer corners of the vanes into the vane receiving slots.

[0034] Preferably, the first support member inner wall 301D includes a first support member extension 311 that forms a portion of the vertical slot 361 for receiving a portion of the inner edge of the first vane, and the second support member inner wall 302D includes a second support member extension 312 that forms a portion of the vertical slot 362 for receiving a portion of the inner edge of the second vane. The illustrated aspect also shows third and fourth support member inner walls including extensions 313, 314 that form vertical slots 363, 364. Illustratively, the support member inner walls can include a "J-shaped", "L-shaped", or "C-shaped" arm that forms one inner side of the vertical slot, with the support member front or back wall forming the opposite inner side of the vertical slot (see, e.g.,Figure 1A arm 311A and the front wall 301A).

[0035] In the illustrated aspect, the first support member 301 has a first support member bottom end 331 that includes a catch 381 for lockably receiving a portion of the lower edge of the first vane (see Figure 5A ), and the second support member 302 has a second support member bottom end 332 that includes a catch 382 for lockably receiving a portion of the lower edge of the second vane. The illustrated aspect also shows third and fourth support member bottom ends 333, 334, including catches 383, 384.

[0036] Preferably, to facilitate lockable receipt of a portion of the lower edge of the vane, the support member catches 381, 382 each include a hook (bent or angled back) 391, 392, respectively, where the catches 383, 384 are also shown.

[0037] Figure 5A and 5B A vane assembly 2000 is shown according to an aspect of the present application, where Figure 1A aspects of the guard 500 shown in Figure 4A engage aspects of the vane 1000 shown in, where portions of the vane are received in components of the guard as described above. Thus, the inner edge of the vane is positioned in the vertical slot of the guard, the upper outer corner of the vane is optionally positioned in the vane receiving slot after the contact protrusion, where the angled portion of the contact protrusion helps guide the upper outer corner into the vane receiving slot, and a portion of the lower edge of the vane is lockably received in the catch. In this case, "lockably received" means that it is difficult to remove the lower edge of the vane from the catch.

[0038] Figure 6A A perspective view of a vane assembly 3000 is shown according to an aspect of the present application, including Figure 5A and 5B aspects of the vane assembly shown, where the assembly further includes a pin 1300 and a seat fitting 1350 for mounting on a biological container (such as Figure 8 a biological container 4001 shown in). As Figure 6B shown, the illustrated pin 1300 has a head 1301, a tip 1302, a shaft 1310 that connects with the head at one end and the tip at the other end, where the shaft further includes a rib 1315 and the tip includes a ridge 1320, and the pin has a chamfer 1325 between the shaft and the tip. As Figure 6CAs shown, the seat fitting 1350 has a first (upper) surface 1351 and a second (lower) surface 1352. As will be discussed in greater detail below, the lower surface 1352 is to be affixed (e.g., welded) to an interior surface of a bioreactor.

[0039] The illustrated seat fitting 1350 has a hollow extension 1375 with a central opening 1390 at a first (upper) end 1376 of the extension for receiving the pin 1300, wherein the seat fitting 1350 further includes an interior fitting chamfer 1326 (as Figure 7B As shown. Figure 6C An extension is shown extending upwardly from the first surface 1351, which also extends downwardly from the lower surface 1352 and is closed at a second (lower) end (see Figure 7B , showing another aspect of the impeller assembly 3000A, wherein the extension includes a closed lower end 1377). Once the pin 1300 is fully inserted through the impeller opening 1090 and the fitting opening 1390, the ridge 1320 provides a friction fit to a lower portion of the fitting chamfer 1326, and the pin chamfer 1325 also provides friction, preventing the pin from disengaging from the fitting.

[0040] Figure 7A Figs. 7A (perspective view) and 7B (cross-sectional view) show another impeller assembly 3000A according to an aspect of the present application, which is generally similar to the aspect shown in Figure 6A However, Figure 7A and 7B The aspect shown in Figs. 7A and 7B includes a bearing assembly 1400 disposed between the hub of the impeller and the first surface 1351 of the seat fitting 1350. As with the impeller assembly 3000, the illustrated aspect of the impeller assembly 3000A includes the pin 1300 fully inserted through the impeller opening 1090 and the fitting opening 1390, the ridge 1320 providing a friction fit to a lower portion of the fitting chamfer 1326, and the pin chamfer 1325 also providing friction, preventing the pin from disengaging from the fitting.

[0041] Aspects of the present application are applicable to a variety of bioreactor and bioreactor systems, preferably single-use bioreactor and bioreactor systems, and / or for use in maintaining a closed, sterile system. For example, the bioreactor can have any suitable shape and internal volume, as well as any number of ports and / or fittings and / or fluid conduits, such as tubing. The bioreactor has at least two ports, namely an inlet port and a drain port, and can have one or more additional ports, such as ports for any one or more of the following: sampling, venting, monitoring (e.g., for monitoring any one or more of the following: oxygen, temperature, pH), and additives. The bioreactor includes a bottom wall, a top wall, and at least one side wall, the side wall being connected to the top wall and the bottom wall.

[0042] Figure 8An illustrative bioreactor system 4000 according to one aspect of the application is shown, including a bioreactor 4001 including an enclosed container having an interior volume for containing fluid, with an aspect of an impeller system (e.g., as shown in Figure 6A or Figure 7A The illustrated bioreactor 4001 includes a flexible bioreactor bag 4010 including an inlet port 4171, an outlet port 4172, a top wall 4111, a bottom wall 4112 having an inner surface 4151 and an outer surface 4152, and opposing side walls 4113, 4114, 4115, 4116, providing an interior volume in the bag, with the aspect of the impeller system having the lower surface 1352 of the seat fitting 1350 fixed (e.g., welded) to the inner surface 1451 of the bioreactor. Although not shown in Figure 8 the enclosed lower end 1377 of the seat fitting extension passes through the outer surface 4152 of the bioreactor to mate with a drive system including a motor for rotating the impeller.

[0043] A number of materials and processes are suitable for producing the guard according to the application. Suitable materials include, for example, thermoplastic resins such as polypropylene and polyethylene (e.g., high density polyethylene). Suitable processes include, for example, injection molding.

[0044] A number of impellers are suitable for use in various aspects of the application, and are commercially available. Suitable impellers include magnetic impellers and levitated impellers, for example, under the names Mixers and ALLEGRO TM magnetic mixers (Pall Corporation, East Hills, New York).

[0045] A number of bioreactors and bioreactor system impellers are suitable for use in various aspects of the application (i.e., impeller systems according to aspects of the system can be installed on bioreactors), and are commercially available.

[0046] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were specifically set forth in its entirety herein.

[0047] The use of the terms "a" and "the" and "at least one of" and similar referents in the context of describing the application (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The use of the term "at least one of" followed by a list of two or more items, such as "at least one of A and B," is to be interpreted to mean that one item from among the listed items (i.e., A or B) or any combination of two or more of the listed items (i.e., A and B) can be present (e.g., A or B or A and B). The terms "comprises," "has," "includes," and "containing" and other similar forms are all to be construed as open-ended terms (i.e., meaning "including, but not limited to,") unless otherwise noted. As used herein, recitation of ranges of values

[0048] Preferred aspects of the application are described herein, including the best mode known to the inventors for practicing the application. Variations of those preferred aspects will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventors expect skilled artisans to employ such variations as appropriate, and the inventors intend for the application to embrace all such modifications and approximations of the subject matter described herein. Additionally, and unless otherwise specified herein, the present application encompasses any and all combinations of the above-described elements in all possible variations.

Claims

1. A guard for an impeller, the impeller having at least a first blade and a second blade, each of the first blade and the second blade having a front blade face and a back blade face, an upper edge, an outer edge, an upper outer corner, a lower edge, and an inner edge, the upper edge meeting the outer edge at the upper outer corner, the guard comprising: (A) an upper annular ring having an upper annular ring horizontal axis and a first inner diameter, the upper annular ring having an upper surface and a lower surface, wherein the upper surface further comprises a peripheral edge having a rounded surface, and wherein the lower surface comprises at least: a first blade receiving slot for receiving the upper outer corner of the first blade, the first blade receiving slot having a first side and a second side; and a second blade receiving slot for receiving the upper outer corner of the second blade, the second blade receiving slot having a first side and a second side; (B) a lower annular ring having a lower annular ring horizontal axis and a second inner diameter, wherein the second inner diameter is smaller than the first inner diameter; (C) at least a first support member and a second support member, each of the first support member and the second support member being attached to the upper annular ring and the lower annular ring, each of the first support member and the second support member being disposed vertically between the upper annular ring and the lower annular ring and perpendicular to the upper annular ring horizontal axis and the lower annular ring horizontal axis, (1) the first support member having a first support member front wall, a first support member back wall, a first support member outer side wall, and a first support member inner side wall, the first support member inner side wall being in contact with the lower annular ring, the first support member front wall or the first support member back wall being disposed to face the front blade face or the back blade face of the first blade and form the second side of the first blade receiving slot; (a) the first support member having: a vertical slot for receiving a portion of the inner edge of the first blade; and a gripping portion for lockably receiving a portion of the lower edge of the first blade; (2) the second support member having a second support member front wall, a second support member back wall, a second support member outer side wall, and a second support member inner side wall, the second support member inner side wall being in contact with the lower annular ring, the second support member front wall or the second support member back wall being disposed to face the front blade face or the back blade face of the second blade and form the second side of the second blade receiving slot; (b) the second support member having: a vertical slot for receiving a portion of the inner edge of the second blade; and a gripping portion for lockably receiving a portion of the lower edge of the second blade.

2. The guard of claim 1 wherein the lower surface of the upper annular ring comprises: a first protrusion spaced apart from the front blade face or the back blade face of the first blade by a distance and forming the first side of the first blade receiving slot; and a second protrusion spaced apart from the front blade face or the back blade face of the second blade by a distance and forming the first side of the second blade receiving slot.

3. The guard of claim 1 or 2, wherein the first support member inner side wall comprises a first support member extension forming a portion of the vertical slot for receiving a portion of the inner edge of the first blade, and the second support member inner side wall comprises a second support member extension forming a portion of the vertical slot for receiving a portion of the inner edge of the second blade.

4. The guard of claim 1 or 2, wherein the first support member has a first support member bottom end that includes the grip for lockably receiving a portion of the lower edge of the first vane, and the second support member has a second support member bottom end that includes the grip for lockably receiving a portion of the lower edge of the second vane.

5. The guard of claim 1 or 2, wherein the grip of the first support member and the grip of the second support member each include a hook portion.

6. An impeller assembly comprising: an impeller having at least a first vane and a second vane, each of the first vane and the second vane having a front vane face and a back vane face, an upper edge, an outer edge, an upper outer corner, a lower edge, and an inner edge, the upper edge meeting the outer edge at the upper outer corner; and the guard of any one of claims 1-5 mounted to the impeller.

7. A method of mounting the guard of any one of claims 1-5 to an impeller, the method comprising: positioning the inner edge of the vane of the impeller in the vertical slot of the corresponding support member; positioning the upper outer corner of the vane of the impeller in the corresponding vane receiving slot; and positioning the lower edge of the vane of the impeller in the grip of the corresponding support member.

8. An impeller system comprising the impeller assembly of claim 6, wherein the impeller has a central opening, the impeller assembly further comprising a pin and seat fitting.

9. A biocontainer system comprising: (a) a biological container comprising a closed container having an internal volume adapted to contain a fluid, the container comprising a bottom wall, a top wall, at least one side wall connected to the top wall and the bottom wall; and at least an inlet port and a discharge port, wherein the biological container further comprises: (b) the impeller system of claim 8, wherein the impeller is mounted to an inner surface of the bottom wall of the biological container.

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