Systems and methods for aligning magnetic drive units

Abstract

An apparatus for aligning a bioprocessing drive head includes: a rotary and sliding bearing assembly configured to operatively connect a drive motor to a rotatable shaft; and a drive head operatively connected to the rotatable shaft, configured to rotate an impeller within a bioprocessing container. The apparatus further includes a linear motion mechanism operatively connected to a rotary ball spline mechanism and / or the rotatable shaft. The linear motion mechanism is configured to linearly move the drive head via the rotatable shaft to operatively contact the impeller, without linearly moving the drive motor.

Description

[0001] Cross-references to related applications This patent application relates to two concurrently filed, co-pending, and co-assigned U.S. patent applications entitled "Flexible Bioprocessing Vessel and Rigid Support Structure" (Attorney General's File No.: P2023-3886-US01) and "Apparatus, System, and Method for Transporting and Installing a Flexible Bioprocessing Vessel" (Attorney General's File No.: P2023-3885-US01), the disclosures of which are incorporated herein by reference. Technical Field

[0002] Embodiments of the present invention generally relate to biological treatment, and more specifically, to a system and method for aligning the drive head of a drive motor assembly with the impeller of a biological treatment container. Background Technology

[0003] Mixers and bioreactors are frequently used for biochemical and biological processes and / or to manipulate the liquids and other products of these processes. These devices typically use disposable containers, such as flexible or collapsible bags supported by an external rigid support structure (e.g., a stainless steel shell / canister). As will be understood, the use of sterilized disposable bags eliminates the time-consuming step of cleaning the canister after each use and reduces the chance of contamination.

[0004] In use, a disposable / single-use bag is positioned within a rigid container and filled with the desired fluid for processing. An impeller assembly, including a rotating impeller with one or more blades, is disposed within the bag and used to mix the fluid. Existing impeller systems are either top-driven, having a shaft extending downward into the bag on which one or more impellers are mounted, or bottom-driven, having an impeller disposed at the bottom of the bag, driven by, for example, a magnetic drive system positioned outside the bag.

[0005] Magnetic drive impellers typically have a portion fixed (e.g., welded) to the base of the bag. The impeller contains a permanent magnet that can be rotated to cause the impeller to rotate. The permanent magnet of the impeller is magnetically coupled to and driven by a permanent magnet in an external drive motor assembly / drive unit. In use, the drive magnet is rotated, which in turn causes the impeller to rotate, resulting in agitation of the fluid within the bag. In known magnetic drive systems, a drive motor rotates a shaft operatively connected to a drive head containing one or more permanent magnets.

[0006] As will be understood, during the installation of the disposable bag in the support structure / can, the drive head and motor are not initially in contact with the base portion of the impeller. The drive head is magnetically coupled to the impeller only after the bag is aligned and configured for use in the can. Typically, for containers with bottom-driven impellers, the drive head is raised to make magnetic contact with the impeller.

[0007] In known systems, the entire drive motor is linearly raised until the drive head engages the base portion. This is achieved via a linear actuator attached to the drive motor housing, where the housing and the entire drive motor assembly are fixed to the tank. This current solution is complex and utilizes expensive linear modules that can be prone to error. More specifically, the center of gravity of the drive motor assembly is not aligned with the axis of rotation of the shaft connected to the drive head. Given the relatively heavy weight of the motor (approximately 20 kg or more) and the attachment point of the linear lifting system, this generates undesirable eccentric forces on the rotatable shaft and the drive head, requiring a certain degree of backlash in the linear actuator to compensate for this in an attempt to ensure proper alignment of the drive head with the impeller. However, this backlash can lead to inaccurate lifting, placement, and / or alignment of the drive head.

[0008] In view of the above, there is a need for a system and method for aligning a drive head with the impeller of a biological treatment container, which is accurate and does not require a complex and / or expensive and potentially error-prone linear mechanism that lifts the entire drive motor. Summary of the Invention

[0009] Certain embodiments commensurate with the scope of the originally claimed subject matter are summarized below. These embodiments are not intended to limit the scope of the claimed subject matter, but are merely intended to provide a brief overview of possible embodiments. In fact, this disclosure may include various forms that may be similar to or different from the embodiments set forth below.

[0010] According to one aspect of the invention, an apparatus for aligning a bioprocessing drive head includes: a rotary and sliding bearing assembly configured to operatively connect a drive motor to a rotatable shaft; and a drive head operatively connected to the rotatable shaft, the drive head being configured to rotate an impeller within a bioprocessing container. The apparatus further includes a linear motion mechanism operatively connected to a rotary ball spline mechanism and / or the rotatable shaft. The linear motion mechanism is configured to linearly move the drive head via the rotatable shaft to operatively contact the impeller, without linearly moving the drive motor.

[0011] In one embodiment, the rotary and sliding bearing assembly is a rotary ball spline mechanism.

[0012] In one embodiment, the linear motion mechanism is a linear actuator.

[0013] In one embodiment, the rotary ball spline mechanism is located within a housing having a groove and an orifice in an upper housing surface, a rotatable shaft extending from the upper housing surface, and a linear actuator fixed to the rotary ball spline mechanism via the groove.

[0014] In one embodiment, the impeller may include one or more magnets configured to magnetically couple to one or more magnets of the drive head when the drive head and the impeller are in operative contact.

[0015] In one embodiment, the device further includes a drive motor operatively connected to the rotating ball spline mechanism.

[0016] In another embodiment, the linear motion mechanism may be a screw operably connected to a rotatable shaft, and the device further includes a brake configured to selectively prevent the rotating ball spline mechanism from rotating to linearly move the drive head into operably contact with the impeller via the screw and the rotatable shaft.

[0017] In one embodiment, the screw is configured to engage with a threaded orifice in a rotatable shaft.

[0018] According to another aspect of the invention, a system for aligning and rotating a bioprocessing drive head includes: a rigid support structure configured to receive a flexible bioprocessing container having an inner cavity including an impeller. The system further includes: a drive motor attached to an outer surface of the rigid support structure; a rotary ball spline mechanism operatively connecting the drive motor to a rotatable shaft; and a drive head operatively connected to an end of the rotatable shaft opposite to the drive motor, the drive head being configured to rotate the impeller within the bioprocessing container. The system also includes a linear motion mechanism operatively connected to the rotary ball spline mechanism and / or the rotatable shaft. The linear motion mechanism is configured to linearly move the drive head to operatively contact the impeller via the rotatable shaft, without linearly moving the drive motor, and the drive motor is configured to rotate the rotatable shaft and the drive head via the rotary ball spline mechanism to rotate the impeller.

[0019] In one embodiment, the linear motion mechanism is a linear actuator.

[0020] In one embodiment, the rotary ball spline mechanism is located within a housing having a groove and an orifice in an upper housing surface, a rotatable shaft extending from the upper housing surface, and a linear actuator fixed to the rotary ball spline mechanism via the groove.

[0021] In one embodiment, the impeller includes one or more magnets configured to magnetically couple to one or more magnets of the drive head when the drive head and the impeller are in operative contact.

[0022] In another embodiment, the linear motion mechanism may be a screw operably connected to a rotatable shaft, and the system further includes a brake configured to selectively prevent the rotating ball spline mechanism from rotating to linearly move the drive head into operably contact with the impeller via the screw and the rotatable shaft.

[0023] In one embodiment, the screw is configured to engage with a threaded orifice in a rotatable shaft.

[0024] According to another aspect of the invention, a method for aligning a bioprocessing drive head includes: aligning an impeller of a bioprocessing container for magnetic coupling with a drive head of a drive motor located below the impeller and outside the bioprocessing container, the drive head being operatively connected to a rotatable shaft, which in turn is operatively connected to the drive motor via a rotary ball spline mechanism. The method further includes: linearly moving the drive head to operatively engage the impeller via a linear motion mechanism, without linearly moving the drive motor, the linear motion mechanism being operatively connected to the rotary ball spline mechanism and / or the rotatable shaft.

[0025] In one embodiment, the linear motion mechanism is a linear actuator.

[0026] In one embodiment, the method further includes rotating a drive head via a rotatable shaft and a drive motor to rotate the impeller.

[0027] In one embodiment, the method further includes removing the drive head from its operative engagement with the impeller via a linear motion mechanism, wherein the removal of the drive head is performed while the drive motor is not linearly moved.

[0028] In one embodiment, the linear motion mechanism is a screw that engages with a threaded orifice of a rotatable shaft, and the method further includes: activating a brake to prevent the rotation of a rotating ball spline mechanism to linearly move the drive head through the screw and the rotatable shaft to operatively engage with the impeller. Attached Figure Description

[0029] The invention will be better understood by reading the following description of non-limiting embodiments and referring to the accompanying drawings, in which: Figure 1 This is a perspective view of a rigid support structure suitable for use with embodiments of the present invention.

[0030] Figure 2It is an enlarged cross-sectional view of a known magnetic impeller and drive assembly, depicting an exemplary magnetic coupling between the magnet of the drive head and the impeller magnet.

[0031] Figure 3 It is a three-dimensional schematic diagram of a known drive motor lifting mechanism, wherein the drive motor moves linearly to connect the drive head to the impeller.

[0032] Figure 4 This is a perspective view of a device for aligning a biological processing drive head according to an embodiment of the present invention.

[0033] Figure 5 This is a perspective view of a device for aligning a bioprocessing drive head according to another embodiment of the present invention, showing the device attached to the outer surface of a support structure for a bioprocessing container.

[0034] Figure 6 yes Figure 5 A sectional side view of the equipment.

[0035] Figure 7 yes Figure 5 A sectional perspective view of the equipment.

[0036] Figure 8 This is a side view of a rotary ball spline mechanism according to an embodiment of the present invention, the rotary ball spline mechanism being configured for use in... Figures 4-8 In the device embodiment.

[0037] Figure 9 This is a partial sectional view of a rotary ball spline mechanism, depicting its internal components.

[0038] Figure 10 This is a perspective view of a drive motor suitable for use with embodiments of the present invention, depicting a mounting surface and a rotatable connector / hole that is rotated by the drive motor and connected to a rotating ball spline mechanism to rotate the drive head.

[0039] Figure 11 This is a side view of a rotary ball spline mechanism, showing the structure of a rotatable connector / hole that connects the rotary ball spline mechanism to a drive motor.

[0040] Figure 12 yes Figure 11 Another side view of the rotating ball spline mechanism.

[0041] Figure 13 yes Figure 11 A cross-sectional view of the end of a rotary ball spline mechanism.

[0042] Figure 14This is a perspective view of an apparatus for aligning a biological processing drive head according to an alternative embodiment of the present invention, the apparatus utilizing a screw and a brake.

[0043] Figure 15 yes Figure 14 A cross-sectional view of an alternative embodiment. Detailed Implementation

[0044] Exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings, examples of which are shown in the drawings. Wherever possible, the same reference numerals used in all the drawings denote the same or similar parts.

[0045] As used herein, the terms "flexible" or "foldable" refer to a structure or material that is flexible or can be bent without breaking, and may also refer to a compressible or expandable material. An example of a flexible structure is a bag formed from a polyethylene film.

[0046] As used herein, the term "container" refers to a flexible bag, flexible container, semi-rigid container, or rigid container (as the case may be). As used herein, the term "container" is intended to include containers with flexible or partially flexible walls (e.g., bioprocessing containers), disposable flexible bags, and other containers or conduits commonly used in biological or biochemical processes, including, for example, cell culture / purification systems, fermentation systems, mixing systems, culture medium / buffer preparation systems, and filtration / purification systems.

[0047] As used herein, the term "bag" refers to a flexible or semi-rigid container used, for example, as a mixer or bioreactor for its contents.

[0048] The embodiments can be used in conjunction with a variety of biological and chemical processes, which are generally referred to herein as "bioprocessing". This term includes, but is not limited to, various processes that occur in bioreactors, mixers, fermenters, and the like. A "bioprocessing vessel" is a container suitable for use with or in connection with a bioreactor, mixer, fermenter, or other biological or chemical processing apparatus. Certain embodiments may be suitable for other industries / applications where the size, ease of installation, and / or efficient, versatile mixing of fluids is desirable.

[0049] Although described as being used in conjunction with a drive motor utilizing a drive head containing a permanent magnet and an impeller including the permanent magnet, the embodiments are not limited thereto. As will be understood, the embodiments can be adapted for use with various coupling mechanisms between the drive head and the impeller, including purely mechanical connections, connections utilizing both mechanical and magnetic elements, and other coupling mechanisms.

[0050] For reference Figure 1The image depicts a support structure 100 and a flexible bioprocessing container 170 suitable for use with embodiments of the invention. The support structure 100 includes a rigid body 102 having a bottom surface 106 and six rigid panels 108 forming sides around the bottom surface 106 to define a hexagonal interior. The hexagonal interior has a substantially open top and a selectively openable door 112 that allows access to the hexagonal interior and is configured to receive the flexible bioprocessing container. The support structure further includes an outward-facing bottom surface 176 on which various mechanical and / or electrical devices and equipment are located.

[0051] Although the rigid body 102 is depicted as having a hexagonal exterior, the embodiments are not limited to use with support structures or flexible containers having any particular shape. In fact, the embodiments can be widely used with support structures and containers having various shapes, structures, or constructions, including cylindrical, circular, and cuboid / cubic containers / structures. Furthermore, while some embodiments may be particularly well-suited for larger bioprocessing containers and support structures, such as 2000-3000 liters, the embodiments can be used for even larger or smaller bioprocessing containers / structures.

[0052] As shown, the flexible bioprocessing container 170 has an inner cavity configured to receive fluid for treatment. The inner cavity includes an impeller 172, which, in an embodiment, has a base portion or other portion including one or more permanent magnets. The magnets are configured to be coupled to magnets in a drive head of a drive motor, and this magnetic coupling is used to transmit torque from the motor to the impeller 172 to agitate the fluid in the bioprocessing container.

[0053] refer to Figure 2The present invention describes a known magnetic coupling. This coupling is described in U.S. Patent No. 11,065,589, which is incorporated herein by reference in its entirety unless any incorporated material is inconsistent with the express disclosure herein. As shown, impeller 182 includes a plurality of permanent magnets 183A and 183B. Located within a flexible bioprocessing container, impeller 182 is mounted on an impeller seat 184 (also a component of the container), the impeller seat 184 including a shaft 186 about which impeller 182 rotates. Impeller seat 184 is secured in place for use by a locking and centering mechanism 192 as part of a rigid support structure / canister (not shown). Locking and centering mechanism 192 includes a hollow cylindrical housing configured to receive a drive head 188 of a drive motor. In use, drive head 188 is mechanically raised within the hollow cylindrical housing of locking and centering mechanism 192 into the cavity of the impeller seat. The drive head 188 also includes multiple permanent magnets 190A and 190B, which engage with the permanent magnets of the impeller 182 to establish magnetic coupling. A motor rotates the drive head 188, causing the impeller 182 to rotate about axis 186, thereby agitating the fluid in the container. When biological treatment is complete, the drive head 188 is lowered and disengaged from the magnetic contact with the impeller magnets 183A and 183B, allowing the flexible biological treatment container to be removed from the support structure and disposed of.

[0054] Now transferred to Figure 3 The diagram depicts a conventional drive head lifting mechanism 200. In use, this mechanism is attached to the outer surface of a support structure, such as the outer bottom surface. As shown, the drive head lifting mechanism includes a drive motor 202 operatively connected to a housing, within which a rotatable shaft (not shown) is located. The rotatable shaft is operatively connected to a drive head 208. The mechanism further includes a relatively complex linear actuator module 204 connected to the end of the drive motor near the housing, shaft, and drive head. As shown, this module utilizes a motor 210, a belt drive 212, and several additional components. Importantly, in use, the entire drive motor and operatively connected components are linearly raised until the drive head engages with the base portion of the impeller.

[0055] As mentioned, this lifting mechanism is overly complex and uses expensive linear modules that are prone to error. More specifically, the center of gravity of the entire drive motor assembly is not aligned with the axis of rotation of the shaft connected to the drive head. Given the relatively heavy weight of the drive motor (approximately 20 kg or more), this generates undesirable eccentric forces on the rotatable shaft and drive head, requiring a certain degree of backlash in the linear actuator to compensate for and properly align the drive head. However, this backlash cannot fully compensate for the aforementioned forces, and the result may be inaccurate lifting, placement, and / or alignment of the drive head.

[0056] For reference Figure 4 The illustration depicts an apparatus 300 for aligning a bioprocessing drive head according to an embodiment of the invention. The apparatus 300 includes a drive motor 310 connected to a housing 314 and a linear motion mechanism, which in the illustrated embodiment is a linear actuator 312. The linear actuator 312 is secured to the drive motor 310 by a bracket 322. The housing 314 contains a rotary and sliding bearing assembly, such as a rotary ball spline mechanism (not shown), configured to operatively connect the drive motor to a rotatable shaft 318. The rotatable shaft 318, extending / retracting from an aperture 317 in the housing 314, is operatively connected to a drive head 320 configured to rotate an impeller within a bioprocessing container. As depicted, the drive head 320 is operatively connected to the end of the rotatable shaft opposite the drive motor.

[0057] While the embodiments are described as utilizing a rotary ball spline mechanism, in other embodiments, a combination of rotary and sliding bearing assemblies can be employed to facilitate the rotation of the drive head and its linear movement without requiring a linearly moving drive motor. For example, in embodiments, an assembly of a conventional or ball rotary bearing (for rotary motion) and a ball bushing or sleeve bearing as a sliding bearing (for linear motion) can be used.

[0058] The linear motion mechanism / linear actuator is operatively connected to the rotary ball spline mechanism and / or the rotatable shaft via a slot 316 formed in the housing 314. In use, the linear motion mechanism is configured to move the drive head linearly (e.g., up / down) to operatively contact the impeller via the rotatable shaft, without necessarily moving the drive motor linearly. In this respect, the use of the rotary ball spline mechanism allows the rotatable shaft to move precisely linearly up and down and rotate to drive the drive head and impeller, making linear movement of the drive motor itself unnecessary.

[0059] In fact, regarding the improved accuracy achieved by using a rotating ball spline mechanism, it has been found that the embodiment provides a height accuracy of approximately ±0.05 mm and a concentricity accuracy of approximately ±0.02 mm, both of which are significantly better than the accuracy provided by existing mechanisms that linearly move the entire drive motor.

[0060] For reference Figure 5 and Figure 6 The image depicts a device 400 for aligning a biological processing drive head according to another embodiment. This embodiment is similar to... Figure 4This embodiment differs from the previous one, but the location and configuration of the linear actuator have been modified. As shown, device 400 includes a drive motor 410 connected to a housing 414, which contains a rotary ball spline mechanism (not shown). In this embodiment, the linear actuator 440 is located within an actuator cover 424. The linear actuator / cover is attached (e.g., bolted) to the lower surface of the drive motor 410 via a bracket 426 and may also be secured to the housing 414. As will be understood, the actuator cover 424 does not need to be shaped or formed as depicted.

[0061] In this view, device 400 is shown attached to the outward-facing bottom surface 176 of a support structure. Specifically, device 400 is attached via a support structure flange 180, which in turn is attached to support structure 100. In embodiments, support structure flange 180 may be attached to the support structure by fasteners, welded to the support structure, or otherwise attached, for example, integrally / formed on the bottom surface. As shown, device 400 is attached to support structure 100 via an end flange 415 on housing 414, which is removably secured to support structure flange 180 by a plurality of bolts. Device 400 further includes a cable / connector 427 for providing signals (e.g., MODBUS) and power to linear actuator 440.

[0062] For details, please refer to the following: Figure 6 The figure depicts a linear actuator 440, a rotatable shaft 418, and a drive head 420 in a lowered or retracted position, with multiple components housed within a housing 414. Specifically, a ball spline mechanism 430 and the rotatable shaft 418 are located therein. As shown, the ball spline mechanism 430 is operatively connected to a drive motor 410 and the rotatable shaft 418, which is operatively connected at its distal end to the drive head 420. In one embodiment, the drive head 420 may be selectively removed from the rotatable shaft 418 to replace the drive head, for example, based on the type of bioprocessing container / impeller used. In other embodiments, the drive head 420 may be permanently attached to the rotatable shaft.

[0063] The housing 414 includes a slot 416 through which the linear actuator 440 is secured to a rotary ball spline mechanism. In the depicted embodiment, the linear actuator 440 has a foot 442 extending through the slot 416 and secured (e.g., bolted) to the rotary ball spline mechanism. It is through this connection that the linear actuator 440 linearly (e.g., up / down) moves the rotatable shaft 418 and the drive head 420 into operative contact with the impeller, rather than linearly moving the drive motor 410.

[0064] As will be understood, the size and shape of the slot and foot can vary, as long as the slot provides sufficient travel to effectively raise / lower the drive head to enter and disengage from operative contact with the impeller, and the foot has sufficient contact with the rotating ball spline mechanism / rotatable shaft to raise or lower the drive head.

[0065] In one embodiment, the foot 442 may be pivotally attached to the end of the linear actuator 440. This may facilitate linear movement within a slot, movement of a rotatable shaft, and / or provide ease of assembly. As depicted, the foot 442 may be secured to the linear actuator by bolts or other fasteners. In another embodiment, the foot may be incorporated into or formed in a linearly extendable portion of the actuator.

[0066] In one embodiment, housing 414 includes a mounting flange 490. Housing 414 can be secured to a drive motor via the mounting flange 490, which is bolted to a motor flange 492, which is part of the drive motor 410. Figure 7 In some embodiments, the housing 414 may be attached to the motor 410 by other attachment mechanisms, and the invention is not limited thereto.

[0067] For reference Figure 7 , Figure 8 and Figure 9 In one embodiment, the ball spline mechanism 430 includes a spline shaft 432 having a longitudinally extending channel 439 configured to receive a ball element 452, which is held within a retainer 454 located within an outer cylinder 436. The ball element and the channel allow the outer cylinder 436 to move linearly up and down relative to the linearly fixed spline shaft 432.

[0068] The outer cylinder 436 also includes an annular groove 468 having a plurality of roller elements 459 therein. A mounting flange 434 is mounted on the outer cylinder 436. The mounting flange 434 has an internal channel 462 that allows the outer cylinder 436 to rotate relative to the mounting flange 434; the mounting flange 434 itself does not rotate because it is fixed in rotation in this embodiment. In this embodiment, a foot 442 is attached to the mounting flange 434 by one or more bolts, allowing the outer cylinder 436 to move linearly up and down.

[0069] A rotatable shaft 418 is fixed (e.g., bolted) to the upper portion 437 of the outer cylinder 436. Specifically, the rotatable shaft 418 is connected via a shaft flange 460, which is fastened (e.g., bolted) to the upper portion 437 of the outer cylinder 436 via a fastener hole 466. The rotatable shaft 418 further includes a bore 419, sized to receive the splined shaft 432 and allowing the rotatable shaft 418 to move linearly up and down relative to the linearly fixed splined shaft as the outer cylinder 436 moves linearly via the foot 442 and the linear actuator. The size and shape of the bore 419 are configured to provide a relatively tight fit with the splined shaft 432 without interfering with or restricting the linear movement of the two components relative to each other.

[0070] In this respect, the linear actuator moves the outer cylinder 436 linearly relative to the linearly fixed spline axis via a foot / mounting flange connection. The outer cylinder 436 is attached to the rotatable shaft 418 and the drive head 420, such that those components also move linearly about the spline axis along with the outer cylinder 436. However, although the spline shaft is linearly fixed, it can be rotated by a drive motor, and when the spline shaft rotates, it causes the outer cylinder 436 to rotate, with the rotatable shaft and drive head attached to the outer cylinder 436.

[0071] For reference Figure 10 , Figure 11 , Figure 12 and Figure 13 The splined shaft 432 further includes a diameter reduction portion 438 configured to engage the drive motor 410, enabling the motor to rotate the splined shaft / outer cylinder 436 / rotatable shaft 418 assembly. More specifically, the diameter reduction portion 438 includes a protrusion 441 configured (e.g., sized / shaped) to fit into a recess 413 in a rotatable drive bore 411 in the drive motor 410. Figure 10 ).

[0072] The diameter reduction portion 438 further includes a bore 445 configured to receive a fastener 470 to secure the rotary ball spline mechanism 430 to the drive motor 410. Figure 7 As will be understood, the size and shape of the protrusion 441 can vary, and the invention is not limited thereto. The shape / size of the protrusion 441 is determined by the size and shape of other keying structures in the recess 413 or bore 445. In other embodiments, different mechanisms may be used to connect the spline shaft to the drive motor, and the embodiments are not limited to any particular configuration.

[0073] For reference Figure 14 and Figure 15An alternative embodiment of the device 500 of the present invention for aligning a biological treatment drive head is depicted. This embodiment utilizes a housing 514, which includes a rotatable shaft 522 located within a ball spline mechanism 530. The rotatable shaft 522 is operatively connected to a drive head 516 and is capable of rotating the drive head to rotate an impeller within the biological treatment container.

[0074] The rotatable shaft 522 has a threaded orifice in which the screw 520 is received. The screw 520, serving as a linear motion mechanism, is located in the rotating bore of a drive motor and is rotated by the motor to raise or lower the rotatable shaft 522 within the ball spline mechanism 530, thereby raising or lowering the drive head. As will be understood, the motor reverses to raise or lower both the rotatable shaft and the drive head.

[0075] The rotation of the rotating bearing in the ball spline mechanism can be prevented by activating the brake 526, so that the outer cylinder 536 of the ball spline mechanism does not rotate when the screw 520 rotates to raise or lower the rotatable shaft. Specifically, the screw 520 engages in a threaded bore, such as the female threaded portion of the rotatable shaft 522. The brake prevents the rotation of the rotating ball spline. This means that when the brake is activated, the rotation of the rotatable shaft 522 is prevented. When the brake is activated, vertical displacement of the outer cylinder 536 and the bearing of the rotating ball spline is also prevented. In these cases, if the screw 520 rotates, the rotatable shaft 522 will move upward or downward (tighten or loosen). This vertical movement is not constrained by the outer cylinder 536 of the ball spline.

[0076] Embodiments of the device of the present invention are made of durable materials such as metal, but the invention is not limited to any particular material. As will be understood in some embodiments, other ball spline mechanisms may be used without departing from the invention. Embodiments of the invention are not limited to a particular type of linear actuator, and various types may be employed. In a specific embodiment, a known 24VDC inline linear actuator with a stroke length of 50mm may be used. The embodiments are also not limited to a particular drive motor. In a specific embodiment, the drive motor is an AC motor with a helical bevel gear unit. This motor has a power output of 0.75kW and a torque output of 22Nm.

[0077] Embodiments of the present invention also conceive of a method for aligning a bioprocessing drive head, the method comprising an initial step of aligning an impeller of a bioprocessing container for magnetic coupling with a drive head of a drive motor assembly located below the impeller and outside the bioprocessing container. The drive head is operatively connected to a rotatable shaft, which is in turn operatively connected to the drive motor via a rotary ball spline mechanism. The method further comprises linearly moving the drive head to operatively engage with the impeller via a linear motion mechanism, without linearly moving the drive motor, the linear motion mechanism being operatively connected to the rotary ball spline mechanism and / or the rotatable shaft. The method further comprises rotating the drive head via the rotatable shaft and the drive motor to rotate the impeller, thereby agitating the fluid in the bioprocessing container. The method may also include removing the drive head from operative engagement with the drive head, which is accomplished without linearly moving the drive motor.

[0078] As used herein, an element or step described in the singular and beginning with the word "a" or "an" should be understood to not exclude the plural form of that element or step unless such exclusion is expressly stated. Furthermore, references to "an embodiment" of the invention are not intended to exclude the existence of additional embodiments that also incorporate the described features. Additionally, unless expressly stated to the contrary, embodiments that "comprise," "include," or "have" one or more elements having a particular property may include additional such elements that do not have said property.

[0079] While the dimensions and material types described herein are intended to define the parameters of the invention, they are by no means limiting, but rather exemplary embodiments. Many other embodiments will be apparent to those skilled in the art after reading the above description.

[0080] Therefore, the scope of the invention should be determined by reference to the appended claims and the full scope of their equivalents. In the appended claims, the terms "comprising" and "therein" are used as common English equivalents of the corresponding terms "including" and "wherein".

[0081] Furthermore, in the appended claims, terms such as "first," "second," "upper," "lower," "bottom," and "top" are used merely as designations and are not intended to impose numerical or positional requirements on their objects. Additionally, the definitions in the following claims are not written in the form of means plus function, and are not intended to be interpreted in this way, unless and until such a claim explicitly uses the phrase "means for..." followed by a functional statement without further structure.

[0082] This written description uses examples to disclose several embodiments of the invention, including the best mode, and also enables those skilled in the art to practice embodiments of the invention, including making and using any apparatus or system and performing any incorporated methods. The patentable scope of the invention is defined by the claims and may include other examples that would occur to those skilled in the art. These other examples are intended to fall 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 that do not substantially differ from the literal language of the claims.

Claims

1. An apparatus for aligning a biological processing drive head, comprising: A rotary and sliding bearing assembly configured to operably connect a drive motor to a rotatable shaft; A drive head operably connected to the rotatable shaft, the drive head being configured to rotate the impeller within the biological treatment container; as well as A linear motion mechanism operably connected to the rotary and sliding bearing assembly and / or the rotatable shaft; The linear motion mechanism is configured to move the drive head linearly to operatively contact the impeller via the rotatable shaft, rather than linearly moving the drive motor.

2. The device according to claim 1, wherein, The rotary and sliding bearing assembly is a rotary ball spline mechanism.

3. The device according to claim 2, wherein, The linear motion mechanism is a linear actuator.

4. The device according to claim 3, wherein, The rotating ball spline mechanism is located inside the housing, which has grooves and orifices in the upper housing surface, and the rotatable shaft extends from the upper housing surface; The linear actuator is fixed to the rotary ball spline mechanism via the slot.

5. The device according to claim 1, wherein, The impeller includes one or more magnets configured to magnetically couple to one or more magnets of the drive head when the drive head and the impeller are in operative contact.

6. The device according to claim 2, further comprising a drive motor operably connected to the rotary ball spline mechanism.

7. The device according to claim 2, wherein, The linear motion mechanism is a screw operably connected to the rotatable shaft, and the device further includes: A brake configured to selectively prevent the rotating ball spline mechanism from rotating to linearly move the drive head into operative contact with the impeller via the screw and the rotatable shaft.

8. The device according to claim 7, wherein, The screw is configured to engage with a threaded orifice in the rotatable shaft.

9. A system for aligning and rotating a biological treatment drive head, comprising: A rigid support structure configured to receive a flexible biological treatment container having an inner cavity including an impeller; A drive motor is attached to the outer surface of the rigid support structure; A rotary ball spline mechanism that operably connects the drive motor to a rotatable shaft; A drive head, operably connected to the end of the rotatable shaft opposite the drive motor, the drive head being configured to rotate the impeller within the biological treatment container; A linear motion mechanism, operably connected to the rotary ball spline mechanism and / or the rotatable shaft; and The linear motion mechanism is configured to move the drive head linearly to operatively contact the impeller via the rotatable shaft, rather than linearly moving the drive motor. The drive motor is configured to rotate the rotatable shaft and the drive head via the rotating ball spline mechanism, thereby causing the impeller to rotate.

10. The system according to claim 9, wherein, The linear motion mechanism is a linear actuator.

11. The system according to claim 10, wherein, The rotating ball spline mechanism is located inside the housing, which has grooves and orifices in the upper housing surface, and the rotatable shaft extends from the upper housing surface; The linear actuator is fixed to the rotary ball spline mechanism via the slot.

12. The system according to claim 9, wherein, The impeller includes one or more magnets configured to magnetically couple to one or more magnets of the drive head when the drive head and the impeller are in operative contact.

13. The system according to claim 9, wherein, The linear motion mechanism is a screw operably connected to the rotatable shaft, and the system further includes: A brake configured to selectively prevent the rotating ball spline mechanism from rotating to linearly move the drive head into operative contact with the impeller via the screw and the rotatable shaft.

14. The system according to claim 13, wherein, The screw is configured to engage with a threaded orifice in the rotatable shaft.

15. A method for aligning a biological treatment drive head, comprising: The impeller of the biological treatment container is aligned for magnetic coupling with the drive head of a drive motor located below the impeller and outside the biological treatment container. The drive head is operatively connected to a rotatable shaft, which is in turn operatively connected to the drive motor via a rotating ball spline mechanism. as well as The drive head is moved linearly to operatively engage with the impeller via a linear motion mechanism, rather than linearly moving the drive motor. The linear motion mechanism is operatively connected to the rotary ball spline mechanism and / or the rotatable shaft.

16. The method according to claim 15, wherein, The linear motion mechanism is a linear actuator.

17. The method of claim 15, further comprising: The impeller is rotated by rotating the drive head via the rotatable shaft and the drive motor.

18. The method of claim 15, further comprising: The drive head is removed from its operative engagement with the impeller by the linear motion mechanism, wherein the removal of the drive head is accomplished without linearly moving the drive motor.

19. The method according to claim 15, wherein, The linear motion mechanism is a screw that engages with a threaded orifice of the rotatable shaft, and the method further includes: Activate the brake to prevent the rotating ball spline mechanism from rotating so as to linearly move the drive head through the screw and the rotatable shaft to operatively engage with the impeller.

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