Impeller protection device

Abstract

A shield device for an impeller, a method of using the shield device, an impeller assembly including the shield device mounted to the impeller, an impeller system, and a bio-container system including the impeller system are disclosed.

Description

[0001] This application is a divisional application of the patent application "Impeller Protection Device" (application number: 202210941697.7) filed on August 8, 2022. Technical Field

[0002] This invention relates to impeller protection devices. Background Technology

[0003] The preparation of fluids, particularly solutions and suspensions in the pharmaceutical and biopharmaceutical industries, typically involves thorough mixing to provide a desired component distribution in the product. Many mixing operations are carried out in bioreactor bags using mixing impellers mounted near the bottom of the vessel. A variety of impellers with different sizes of impeller hubs, impeller blades, and / or blade configurations are available for mixing.

[0004] However, damage to the bioreactor bag can compromise the sterility of the fluid inside, leading to the loss of valuable fluid. Summary of the Invention

[0005] The present invention at least mitigates some of the disadvantages of the prior art. These and other advantages of the present invention will become apparent from the following description. One aspect of the present invention provides a protective device for 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 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, the protective device 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 includes at least: a first blade receiving groove for receiving the upper outer corner of the first blade, the first blade... A blade receiving groove has a first side and a second side; a second blade receiving groove for receiving the upper outer corner of the second blade, the second blade receiving groove 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 vertically arranged between the upper annular ring and the lower annular ring and perpendicular to the axis. The upper annular ring horizontal axis and the lower annular ring horizontal axis, (1) the first support member has a first support member front wall, a first support member rear wall, a first support member outer wall and a first support member inner wall, the first support member inner wall is in contact with the lower annular ring, the first support member front wall or the first support member rear wall is arranged to face the front blade surface or the rear blade surface of the first blade, and forms the second side of the first blade receiving groove; (a) the first support member has: a vertical groove for receiving a portion of the inner edge of the first blade; and a gripping part for lockingly receiving the first blade. (a) a portion of the lower edge of the second blade; (b) the second support member has a front wall, a rear wall, an outer wall and an inner wall, the inner wall of the second support member being in contact with the lower annular ring, the front wall or the rear wall of the second support member being arranged to face the front or rear blade surface of the second blade and forming a second side portion of the second blade receiving groove; (c) the second support member has: a vertical groove for receiving a portion of the inner edge of the second blade; and a gripping portion for lockingly receiving a portion of the lower edge of the second blade.

[0006] In another aspect, an impeller assembly is provided, 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 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; and a protective device according to one aspect of the invention, mounted on the impeller.

[0007] 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.

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

[0009] On the other hand, a biological container system is involved, comprising: (a) a biological container including a closed container having an internal volume suitable for containing fluid, the container including 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 an outlet port, wherein the biological container further comprises: (b) an aspect of an impeller system, wherein an impeller is mounted to an inner surface of the bottom wall of the biological container. Attached Figure Description

[0010] Figure 1A and 1B These are top and bottom perspective views of a protective device for an impeller according to one aspect of the present invention.

[0011] Figure 2A and 2B They are Figure 1A Top and bottom views of one aspect of the protective device are shown.

[0012] Figure 3 yes Figure 1A A side view of one aspect of the protective device shown.

[0013] Figure 4A and 4B These are, respectively, a top perspective view and a top view of an impeller suitable for use with a protective device according to one aspect of the present invention.

[0014] Figure 5A and 5B These are, respectively, a top perspective view and a top view of an impeller assembly according to one aspect of the present invention, including an impeller mounted on the impeller shown in FIG4. Figure 1A The protective device shown.

[0015] Figure 6A This is a perspective view of an impeller system according to one aspect of the present invention, including... Figure 5A The impeller assembly shown has an impeller with a central opening, a pin, and a seat fitting. The pin passes through the central opening and enters the seat fitting for mounting the impeller system to a biological container, which includes a closed container having an internal volume for containing fluid. Figure 6B This is a perspective view of the pin. Figure 6C This is a top-down perspective view of the component.

[0016] Figure 7A This is a perspective view of an impeller system according to another aspect of the invention, including an impeller assembly (with protective devices removed for ease of observation), the impeller assembly including a base including a bearing in a frame, and a pin and a seat fitting, the pin passing through a central opening into the seat fitting for mounting the impeller system to a biological container, the biological container including a closed container having an internal volume for containing fluid. Figure 7B yes Figure 7A The figure shows a cross-sectional view of the impeller system.

[0017] Figure 8 This is a side view of a biocontainer system according to one aspect of the invention, including a biocontainer comprising a closed container having an internal volume for containing fluid, and further comprising... Figure 6A The impeller system shown is mounted on a biological container. Detailed Implementation

[0018] One aspect of the present invention provides a protective device for 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 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, the protective device 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 includes at least: a first blade receiving groove for receiving the upper outer corner of the first blade, the first blade... A blade receiving groove has a first side and a second side; a second blade receiving groove for receiving the upper outer corner of the second blade, the second blade receiving groove 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 vertically arranged between the upper annular ring and the lower annular ring and perpendicular to the axis. The upper annular ring horizontal axis and the lower annular ring horizontal axis, (1) the first support member has a first support member front wall, a first support member rear wall, a first support member outer wall and a first support member inner wall, the first support member inner wall is in contact with the lower annular ring, the first support member front wall or the first support member rear wall is arranged to face the front blade surface or the rear blade surface of the first blade, and forms the second side of the first blade receiving groove; (a) the first support member has: a vertical groove for receiving a portion of the inner edge of the first blade; and a gripping part for lockingly receiving the first blade. (a) a portion of the lower edge of the second blade; (b) the second support member has a front wall, a rear wall, an outer wall and an inner wall, the inner wall of the second support member being in contact with the lower annular ring, the front wall or the rear wall of the second support member being arranged to face the front or rear blade surface of the second blade and forming a second side portion of the second blade receiving groove; (c) the second support member has: a vertical groove for receiving a portion of the inner edge of the second blade; and a gripping portion for lockingly receiving a portion of the lower edge of the second blade.

[0019] In some aspects of the protective device, the lower surface of the upper annular ring includes: a first protrusion spaced at a certain distance from the front or rear blade surface of the first blade and forming a first side portion of the first blade receiving groove; and a second protrusion spaced at a certain distance from the front or rear blade surface of the second blade and forming a first side portion of the second blade receiving groove.

[0020] Alternatively or additionally, in some aspects, the inner wall of the first support member includes a first support member extension that forms part of a vertical groove for receiving a portion of the inner edge of the first blade, and the inner wall of the second support member includes a second support member extension that forms part of a vertical groove 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, the first support member bottom end including the gripping portion 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, the second support member bottom end including the gripping portion for lockably receiving a portion of the lower edge of the second blade.

[0022] In some respects, both the gripping portion of the first support member and the gripping portion of the second support member include a hook.

[0023] On the other hand, an impeller assembly is provided, 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 rear 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 protective device for the impeller, the protective device 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 includes at least: a first blade receiving groove for receiving the upper outer corner of the first blade. (A) A first blade receiving groove having a first side portion and a second side portion; a second blade receiving groove for receiving the upper outer corner portion of a second blade, the second blade receiving groove having a first side portion and a second side portion; (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 vertically arranged between the upper annular ring and the lower annular ring and perpendicular to the upper annular ring. The horizontal axis of the annular ring and the horizontal axis of the lower annular ring, (1) the first support member has a front wall of the first support member, a rear wall of the first support member, an outer wall of the first support member and an inner wall of the first support member, the inner wall of the first support member is in contact with the lower annular ring, the front wall of the first support member or the rear wall of the first support member is arranged to face the front blade surface or the rear blade surface of the first blade, and forms a second side of the first blade receiving groove; (a) the first support member has: a vertical groove for receiving a portion of the inner edge of the first blade; and a gripping portion for lockingly receiving a portion of the lower edge of the first blade. (a) The second support member has a front wall, a rear wall, an outer wall, and an inner wall, the inner wall of which contacts the lower annular ring, the front wall or the rear wall of which is arranged to face the front or rear blade surface of the second blade and form a second side portion of the second blade receiving groove; (b) The second support member has a vertical groove for receiving a portion of the inner edge of the second blade; and a gripping portion for lockingly receiving a portion of the lower edge of the second blade, the protective device being mounted on the impeller.

[0024] In another aspect, an impeller system is provided, comprising one aspect of an impeller assembly including: 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 rear 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 protective device for the impeller, the protective device 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 includes at least: a first blade receiving groove for receiving... The upper outer corner of the first blade is received, and the first blade receiving groove has a first side and a second side; a second blade receiving groove is used to receive the upper outer corner of the second blade, and the second blade receiving groove has 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 arranged vertically between the upper annular ring and the lower annular ring and Perpendicular to the horizontal axis of the upper annular ring and the horizontal axis of the lower annular ring, (1) the first support member has a front wall, a rear wall, an outer wall and an inner wall, the inner wall of the first support member is in contact with the lower annular ring, the front wall or the rear wall of the first support member is arranged to face the front or rear blade surface of the first blade, and forms a second side portion of the first blade receiving groove; (a) the first support member has: a vertical groove 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 has a front wall, a rear wall, an outer wall, and an inner wall, the inner wall of which contacts the lower annular ring, the front wall or the rear wall of which is arranged to face the front or rear blade surface of the second blade and form a second side portion of the second blade receiving groove; (b) The second support member has: a vertical groove for receiving a portion of the inner edge of the second blade; a gripping portion for lockingly receiving a portion of the lower edge of the second blade, the protective device being mounted on the impeller; a pin; and a seat fitting.

[0025] In another aspect, a biocontainer system is provided, comprising: (a) a biocontainer including a closed container having an internal volume suitable for containing fluid, the container including a bottom wall, a top wall, and at least one side wall connected to the top wall and the bottom wall; and at least an inlet port and an outlet port, wherein the biocontainer further comprises: (b) an aspect of an impeller system including an aspect of an impeller assembly including: 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 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; and to And a protective device for an impeller, the protective device comprising: (A) an upper annular ring having a horizontal axis and a first inner diameter, the upper annular ring having an upper surface and a lower surface, wherein the lower surface includes at least: a first blade receiving groove for receiving the upper outer corner of a first blade, the first blade receiving groove having a first side and a second side; a second blade receiving groove for receiving the upper outer corner of a second blade, the second blade receiving groove having a first side and a second side; (B) a lower annular ring having a 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 To the upper and lower annular rings, each of the first and second support members is arranged vertically between the upper and lower annular rings and perpendicular to the horizontal axis of the upper and lower annular rings, (1) the first support member has a first support member front wall, a first support member rear wall, a first support member outer wall and a first support member inner wall, the first support member inner wall is in contact with the lower annular ring, the first support member front wall or the first support member rear wall is arranged to face the front or rear blade surface of the first blade and form a second side portion of the first blade receiving groove; (a) the first support member has: a vertical groove for receiving a portion of the inner edge of the first blade; and a gripping portion for locking (a) The second support member has a front wall, a rear wall, an outer wall, and an inner wall, the inner wall of which contacts the lower annular ring, the front wall or the rear wall of which is arranged to face the front or rear blade surface of the second blade and form a second side portion of the receiving groove for the second blade; (b) The second support member has: a vertical groove for receiving a portion of the inner edge of the second blade; and a gripping portion for lockingly receiving a portion of the lower edge of the second blade, the protective device being mounted on the impeller; a pin; and a seat fitting; wherein the impeller is mounted on the 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 3The upper annular ring has a first inner diameter of 175 and an upper surface 101 and a lower surface 102, wherein the lower surface includes at least: a first blade receiving groove 371 for receiving the upper outer corner of the first blade (see...). Figure 5A The first blade receiving slot has a first side portion and a second side portion 371A, 371B (see...). Figure 2B The impeller comprises four blades, and the protective device includes third and fourth blade receiving grooves 373 and 374 for receiving the upper outer corner of the third and fourth blades, the second blade receiving groove having a first side portion and a second side portion 372A, 372B. In the illustrated aspect, the impeller comprises four blades, and the protective device includes third and fourth blade receiving grooves 373 and 374 for receiving the respective upper outer corners of the third and fourth blades, having first and second side portions 373A, 373B, 374A, 374B respectively.

[0032] In the aspects shown, 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 smaller than the first inner diameter 175; at least a first support member 301 and a second support member 302, each attached to the upper annular ring and the lower annular ring, each of the first support member and the second support member being arranged vertically VA between the upper annular ring and the lower annular ring and perpendicular to the horizontal axis of the upper annular ring and the horizontal axis of the lower annular ring, 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 wall 301C and a first support member inner wall 301D, the first support member inner wall contacting the lower annular ring, the first support member front wall or the first support member rear wall being arranged to face the front blade surface or the rear blade surface of the first blade and forming a second side portion 371B of the first blade receiving groove 371; (a) the first support member having a vertical groove 361 for receiving a portion of the inner edge of the first blade, and a gripping portion 381 for lockably receiving a portion of the lower edge of the first blade (see Figure 5A and 5B(a) The second support member 302 has a front wall 302A, a rear wall 302B, an outer wall 302C, and an inner wall 302D. The inner wall of the second support member contacts the lower annular ring. The front wall or the rear wall of the second support member is arranged to face the front or rear blade surface of the second blade and form a second side portion 372B of the second blade receiving groove 372. (b) The second support member has a vertical groove 362 for receiving a portion of the inner edge of the second blade and a gripping portion 382 for lockingly receiving a portion of the lower edge of the second blade. In the illustrated aspect, the impeller includes four blades, and the protective device includes third and fourth support members 303 and 304, which respectively have a front wall, a rear wall, an outer wall and an inner wall 303A, 303B, 303C, 303D, 304A, 304B, 304C, 304D, vertical grooves 363 and 364 and gripping parts 383 and 384.

[0033] If expected (see) Figure 2B The lower surface 102 of the upper annular ring may include: a first protrusion 351 (shown as a double protrusion if increased robustness is desired), which is spaced apart from the front or rear blade surface of the first blade and forms a first side 371A of the first blade receiving groove 371; and a second protrusion 352 (shown as a double protrusion if increased robustness is desired), which is spaced apart from the front or rear blade surface of the second blade and forms a first side 372A of the second blade receiving groove 372. The illustrated aspect also shows third and fourth protrusions 353, 354 (each shown as a double protrusion if increased robustness is desired), forming the first sides 353A, 354A of the corresponding third and fourth blade receiving grooves 373, 374.

[0034] If desired, the upper corner of the protrusion leading to the first side of the blade receiving slot can be tilted downwards (see...). Figure 1B (Examples 351A, 352A, 353A, and 354A are shown) to facilitate guiding the upper outer corner of the blade into the blade receiving slot.

[0035] Preferably, the inner wall 301D of the first support member includes a first support member extension 311 that forms part of a vertical groove 361 for receiving a portion of the inner edge of the first blade, and the inner wall 302D of the second support member includes a second support member extension 312 that forms part of a vertical groove 362 for receiving a portion of the inner edge of the second blade. The illustrated aspects also show third and fourth inner walls of the support members, including extensions 313, 314 forming vertical grooves 363, 364. Illustratively, the inner walls of the support members may include “J-shaped,” “L-shaped,” or “C-shaped” arms forming an inner portion of the vertical groove, wherein the front or rear wall of the support member forms an opposite inner portion of the vertical groove (e.g., see...). Figure 1A (The middle arm 311A ​​and the anterior wall 301A).

[0036] In the illustrated aspect, the first support member 301 has a first support member bottom end 331, which includes a gripping portion 381 for lockably receiving a portion of the lower edge of the first blade (see Figure 1). Figure 5A The second support member 302 has a second support member bottom end 332, which includes a gripping portion 382 for lockably receiving a portion of the lower edge of the second blade. The illustrated aspects also show the bottom ends 333 and 334 of the third and fourth support members, including gripping portions 383 and 384.

[0037] Preferably, in order to facilitate the lockable reception of the lower edge portion of the blade, each of the support member gripping portions 381, 382 correspondingly includes hook portions (bent or bent backward at an angle) 391, 392, wherein the figures also show gripping portions 383, 384, which respectively include hook portions 393, 394.

[0038] Figure 5A and 5B An impeller assembly 2000 according to one aspect of the present invention is shown, wherein Figure 1A The protective device 500 shown is similar to Figure 4A The impeller 1000 shown is engaged in a manner in which a portion of the blade is received within a component of the protective device as described above. Thus, the inner edge of the blade is positioned in a vertical slot of the protective device, and the upper outer corner of the blade is optionally positioned in a blade receiving slot after a contact protrusion, wherein the inclined portion of the contact protrusion facilitates guiding the upper outer corner into the blade receiving slot, and a portion of the lower edge of the blade is lockably received in a gripping portion. In this case, "lockably received" indicates that removing the lower edge of the blade from the gripping portion is difficult.

[0039] Figure 6A A perspective view of an impeller assembly 3000 according to one aspect of the present invention is shown, including... Figure 5A and 5B The impeller assembly shown also includes a pin 1300 and a seat fitting 1350 for mounting on a bioreactor (such as...). Figure 8 On the biological container 4001 shown. (As shown in the image) Figure 6B As shown, the pin 1300 has a head 1301, an end 1302, and a shaft 1310 connected at one end to the head and at the other end to the end. The shaft also includes a rib 1315 and the end includes a ridge 1320. The pin has a chamfered portion 1325 between the shaft and the end. Figure 6C As shown, the seat fitting 1350 has a first (upper) surface 1351 and a second (lower) surface 1352. As will be discussed in more detail below, the lower surface 1352 will be fixed (e.g., welded) to the inner surface of the biocontainer.

[0040] The illustrated seat fitting 1350 has a hollow extension 1375, with a central opening 1390 at the first (upper) end 1376 of the extension for receiving a pin 1300. The seat fitting 1350 also includes an internal fitting chamfer 1326 (as shown). Figure 7B (As shown). Figure 6C An extension extending upward from the first surface 1351 is shown, which also extends downward from the lower surface 1352 and is closed at the second (lower) end (see [reference]). Figure 7B The image shows 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 frictional engagement with the lower portion of the fitting chamfer 1326, and the pin chamfer 1325 also provides friction to prevent the pin from disengaging from the fitting.

[0041] Figures 7A (perspective view) and 7B (sectional view) show another impeller assembly 3000A according to one aspect of the invention, which is generally similar to Figure 6A The aspects shown. However, Figure 7A and 7B The illustrated aspect includes a bearing assembly 1400 disposed between the hub of the impeller and a first surface 1351 of the housing fitting 1350. Similar to the impeller assembly 3000, the illustrated aspect of the impeller assembly 3000A includes a pin 1300 fully inserted through the impeller opening 1090 and the fitting opening 1390. A ridge 1320 provides a frictional engagement with the lower portion of the fitting chamfer 1326, and the pin chamfer 1325 also provides friction to prevent the pin from disengaging from the fitting.

[0042] Various aspects of this invention are applicable to a variety of biocontainers and biocontainer systems, preferably single-use biocontainers and biocontainer systems, and / or aseptic systems for maintaining a closed system. For example, biocontainers can have any suitable shape and internal volume, and any number of ports and / or fittings and / or fluid conduits, such as pipes. Biocontainers have at least two ports, namely an inlet port and an outlet port, and may have one or more additional ports, such as ports for sampling, venting, monitoring (e.g., for monitoring any one or more of the following: oxygen, temperature, pH), and additives. Biocontainers include a bottom wall, a top wall, and at least one side wall connected to the top and bottom walls.

[0043] Figure 8 An illustrative biocontainer system 4000 according to one aspect of the present invention is shown, comprising a biocontainer 4001, the biocontainer including a closed container having an internal volume for containing fluid, wherein one aspect of the impeller system (e.g., as...) Figure 6A or Figure 7A (As shown) mounted on a biocontainer 4001. The illustrated biocontainer 4001 includes a flexible biocontainer bag 4010, which includes 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 internal volume within the bag, wherein aspects of the impeller system allow the lower surface 1352 of the seat fitting 1350 to be secured (e.g., welded) to the inner surface 1451 of the biocontainer. Although in Figure 8 Not shown, but the closed lower end 1377 of the seat fitting extension passes through the outer surface 4152 of the biocontainer to engage with a drive system including a motor for rotating the impeller.

[0044] Many materials and processes are suitable for producing the protective device according to the invention. Suitable materials include, for example, thermoplastic resins such as polypropylene and polyethylene (e.g., high-density polyethylene). Suitable processes include, for example, injection molding.

[0045] Various impellers are applicable to all aspects of the present invention and are commercially available. Suitable impellers include magnetic impellers and suspended impellers, such as those available under the names LEVMIXER® mixer and ALLEGRO™ magnetic mixer (Park Company, East Mountain, New York).

[0046] Various biological containers and biological container system impellers are applicable to all aspects of the present invention (i.e., impeller systems according to various aspects of the system can be installed on biological containers) and are commercially available.

[0047] All references cited in this article, including publications, patent applications and patents, are incorporated herein by reference as if each reference were individually and specifically indicated as incorporated herein by reference and described in its entirety.

[0048] In the context of describing the invention (particularly in the context of the appended claims), the terms “a” and “the,” “the,” and “at least one,” and similar designations, should be interpreted as encompassing both singular and plural aspects, unless otherwise stated herein or obviously contradicted by the context. A list of one or more items following the term “at least one” (e.g., “at least one of A and B”) should be understood to refer to one item selected from the listed items (A or B), or any combination of two or more listed items (A and B), unless otherwise stated herein or obviously contradicted by the context. Unless otherwise stated, the terms “comprising,” “having,” “including,” and “with” should be interpreted as open-ended terms (i.e., meaning “including but not limited to”). Unless otherwise indicated herein, the enumeration of numerical ranges herein is intended only as a way of abbreviating each individual value falling within that range, and each individual value is incorporated into the specification as if it were separately described herein. Unless otherwise indicated herein or obviously contradicted by the context, all methods described herein can be performed in any suitable order. Unless otherwise required, the use of any and all examples or exemplary language (e.g., "such as") provided herein is intended only to better illustrate the invention and does not constitute a limitation on the scope of the invention. No language in the specification should be construed as indicating that any unclaimed element is essential for carrying out the invention.

[0049] This document describes preferred aspects of the invention, including the best modes known to the inventors for carrying out the invention. Variations of those preferred aspects will become apparent to those skilled in the art upon reading the foregoing description. The inventors expect those skilled in the art to appropriately employ such variations, and the inventors wish to practice the invention in ways other than those specifically described herein. Therefore, the invention includes all modifications and equivalents of the subject matter set forth in the appended claims as permitted by applicable law. Moreover, unless otherwise indicated herein or clearly contradicted by the context, the invention covers any combination of the foregoing elements in all possible variations.

Claims

1. A protective device 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 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, the protective device comprising: (A) An upper annular ring having a horizontal axis and a first inner diameter, the upper annular ring having an upper surface and a lower surface, wherein the lower surface includes at least: a first blade receiving groove for receiving the upper outer corner of a first blade, the first blade receiving groove having a first side and a second side; and a second blade receiving groove for receiving the upper outer corner of a second blade, the second blade receiving groove having a first side and a second side. (B) A lower annular ring having a horizontal axis of the lower annular ring 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 arranged vertically between the upper annular ring and the lower annular ring and perpendicular to the horizontal axis of the upper annular ring and the horizontal axis of the lower annular ring. (1) The first support member has a front wall, a rear wall, an outer wall and an inner wall. The inner wall of the first support member is in contact with the lower annular ring. The front wall or the rear wall of the first support member is arranged to face the front or rear blade surface of the first blade and form the second side of the first blade receiving groove. (a) The first support member has: a vertical groove 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 has a front wall, a rear wall, an outer wall, and an inner wall. The inner wall is in contact with the lower annular ring. The front wall or the rear wall is arranged to face the front or rear blade surface of the second blade and forms the second side of the second blade receiving groove. (b) The second support member has: a vertical groove 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 protective device according to claim 1, wherein the lower surface of the upper annular ring comprises: The first protrusion is spaced a certain distance from the front or rear blade surface of the first blade and forms the first side portion of the receiving groove of the first blade. The second protrusion is spaced a certain distance from the front or rear blade surface of the second blade and forms the first side portion of the receiving groove for the second blade.

3. The protective device according to claim 1 or 2, wherein the inner wall of the first support member includes a first support member extension forming part of a vertical groove for receiving a portion of the inner edge of the first blade, and the inner wall of the second support member includes a second support member extension forming part of a vertical groove for receiving a portion of the inner edge of the second blade.

4. The protective device according to any one of claims 1-3, wherein the first support member has a first support member bottom end, the first support member bottom end including the gripping portion 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, the second support member bottom end including the gripping portion for lockably receiving a portion of the lower edge of the second blade.

5. The protective device according to any one of claims 1-4, wherein the gripping portion of the first support member and the gripping portion of the second support member both include a hook.

6. 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 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; and The protective device according to any one of claims 1-5 is mounted on the impeller.

7. A method for installing a protective device according to any one of claims 1-5 onto an impeller, the method comprising: Position the inner edge of the impeller blades in the vertical groove of the corresponding support member; Position the upper outer corner of the impeller blades in the corresponding blade receiving slots; and Position the lower edge of the impeller blades in the gripping part of the corresponding support member.

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

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

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