Sterile centrifuge drive systems

Abstract

A system includes (a) a passive including a spin chamber including a housing defining an interior hollow chamber, and a passive magnetic component connected to the housing. The system also includes (b) an active device including an active magnetic and / or electromagnetic component configured to magnetically couple to the passive magnetic component, wherein when the passive magnetic component and the active magnetic and / or electromagnetic component are coupled, the active magnetic and / or electromagnetic component causes rotation of the spin chamber while maintaining sterility within the spin chamber.

Description

STERILE CENTRIFUGE DRIVE SYSTEMSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 559,998, filed on March 1, 2024, the contents of which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present disclosure relates generally to sterile centrifuge drive systems, e.g., drive systems that do not require a mechanical coupling for imparting rotational motion (e.g., on a spin chamber of the centrifuge). This allows, for example, for integration of a spin chamber part of a centrifuge into a disposable or consumable component, e.g., as used in sterile biological processes.BACKGROUND

[0003] A centrifuge is a device that uses centrifugal force to subject a fluid to a force by spinning the fluid at high speed within a container. A centrifuge can be used to separate fluids of different densities. Denser substances and / or particles move radially, while substances and / or particles that are less dense are displaced and moved towards the center of the centrifuge.

[0004] A wide variety of laboratory centrifuges are used in chemistry, biology, biochemistry, and clinical medicine. Centrifuges can vary widely in speed, capacity, temperature control, and other characteristics.SUMMARY

[0005] The present disclosure provides devices, systems, and methods for imparting rotational motion using drive systems that do not require a mechanical coupling. The drive systems can be used with spin chambers, e.g., centrifuge chambers or centrifuge chambers within cartridges, such as disposable (also referred to herein as “consumable”) spin chambers. For example, the drive systems can impart rotational motion to contents (e.g., liquid contents) of a spin chamber using magnetic and / or electro-magnetic fields without compromising sterility of the contents.

[0006] The devices, systems, and methods disclosed herein are advantageous in that the drive systems can be used to maintain sterility within a spin chamber, e.g., a spin chamber used in cell therapy, such as CAR-T cell therapy. Typically, CAR-T cell therapy consumable spin chambers are mechanically coupled to a driveshaft, where mechanical couplings may pose risks of contamination of the contents within the consumable spin chamber. Imparting rotational motion using the disclosed drive systems, rather than mechanical couplings, allows the consumable spin chamber to remain sealed and mitigates or avoids the risk of contamination. Additionally, the disclosed drive systems may simplify the replacement of consumable spin chambers, for example, in cartridge-based applications.

[0007] In one aspect, the systems include a passive device including a spin chamber including a housing defining an interior hollow chamber, and a passive magnetic component connected to the housing. The systems also include an active device including an active magnetic and / or electromagnetic component configured to magnetically couple to the passive magnetic component, wherein when the passive magnetic component and the active magnetic and / or electromagnetic component are magnetically coupled, the active magnetic and / or electromagnetic component causes rotation of the spin chamber while maintaining sterility within the spin chamber.

[0008] Embodiments can include on or any combination of two or more of the following features.

[0009] The driving devices include a base, and wherein the active magnetic and / or electromagnetic component includes a circular electromagnetic array arranged around a circular opening of the base and configured to electromagnetically couple to the passive magnetic component when the passive magnetic component is nested in the circular opening, wherein the electromagnetic array is configured and electronically controlled to generate one or more electromagnetic fields that cause the spin chamber to rotate with respect to the base when the passive magnetic component of the passive device is nested in the circular opening of the base.

[0010] The active magnetic and / or electromagnetic components can include an active magnetic component configured to magnetically couple to the passive magnetic component, wherein when the passive magnetic component and the active magnetic component are coupled, rotation of the active magnetic component causes rotation of the passive magnetic component while maintaining sterility within the spin chamber.

[0011] The systems can further include a static cap assembly rotatably connected to a top of the spin chamber housing, wherein the static cap assembly includes one or more of: external contact pad areas including anti-slip padding, V-grooves equally distributed around a perimeter of the static cap assembly, and a pattern of holes on a top of the static cap assembly.

[0012] The static cap assembly can further include a fluidic interface configured to flow fluid into and out of the interior hollow chamber within the spin chamber.

[0013] The systems can further include retention brackets configured to connect to and retain the static cap assembly via an interaction with the one or more of the external contact pad areas, V- grooves, and pattern of holes, to retain the static cap assembly without rotation with respect to the active device, thereby magnetically coupling the passive magnetic component to the active magnetic component and enabling the spin chamber to spin with respect to the retention brackets of the active device.

[0014] The static cap assembly can be connected to the housing by a bearing.

[0015] The housings can include counterweights integrated into the wall of the housing and configured to balance the spin chamber during rotation of the spin chamber.

[0016] The interior of the housings can include a contoured surface to balance liquid loads and to receive desired fluid volumes.

[0017] The interior of the housings can include a distribution layer and fluid conduit configured to allow fluid to flow to the periphery of the interior hollow chamber.

[0018] The interior of the housings can include one or more retention fins.

[0019] The active magnetic and / or electromagnetic components can include a magnetic component configured to magnetically couple to the passive magnetic component.

[0020] In another aspect, the systems include a passive device including a spin chamber including a housing defining an interior hollow chamber, and a first magnetic component connected to the housing. The systems further include an active device including a second magnetic component configured to magnetically couple to the first magnetic component, wherein when the passive device and the active device are coupled, rotation of the second magnetic component causes rotation of the first magnetic component while maintaining sterility within the spin chamber.

[0021] Embodiments can include one or any combination of two or more of the following features.

[0022] The systems can further include a static cap assembly rotatably connected to a top of the spin chamber housing, wherein the static cap assembly includes one or more of: external contact pad areas including anti-slip padding, V-grooves equally distributed around a perimeter of the static cap assembly, and a pattern of holes on a top of the static cap assembly.

[0023] The static cap assemblies can further include a fluidic interface configured to flow fluid into and out of the interior hollow chamber within the spin chamber.

[0024] The systems can further include retention brackets configured to connect to and retain the static cap assembly via an interaction with the one or more of the (i) external contact pad areas, (ii) V-grooves, and (iii) pattern of holes, to retain the static cap assembly without rotation with respect to the active device, thereby magnetically coupling the first magnetic component to the second magnetic component and enabling the spin chamber to spin with respect to the retention brackets of the active device when the motor is actuated.

[0025] The static cap assemblies can be connected to the housing by a bearing.

[0026] The housings can include counterweights integrated into the wall of the housing and configured to balance the spin chamber during rotation of the spin chamber.

[0027] The interior of the housings can include a contoured surface to balance liquid loads and to receive desired fluid volumes.

[0028] The interior of the housings can include a distribution layer and fluid conduit configured to allow fluid to flow to the periphery of the interior hollow chamber.

[0029] The interior of the housings can include one or more retention fins.

[0030] In another aspect, the systems include a passive device including an outer housing, a spin chamber arranged within the outer housing and including: a housing defining an interior hollow chamber, and a magnetic component connected to the spin chamber housing. The system also includes an active device including a base including an opening within which the magnetic component of the spin chamber can nest and rotate, and an electromagnetic array arranged around the opening of the base and configured to magnetically couple to the magnetic component when the magnetic component is nested in the opening, wherein the electromagnetic array is configured and electronically controlled to generate one or more electromagnetic fields that cause the spin chamber to rotate with respect to the base and to the outer housing when the magnetic component of the passive device is nested in the opening of the base.

[0031] Embodiments can include one or any combination of two or more of the following features.

[0032] The systems can further include a static cap assembly rotatably connected to a top of the spin chamber housing, wherein the static cap assembly is retained within the outer housing such that the static cap assembly does not rotate with respect to the outer housing and the spin chamber can rotate with respect to the outer housing.

[0033] The static cap assemblies can include one or more of: a plurality of external contact pad areas including anti-slip padding, a plurality of V-grooves equally distributed around a perimeter of the static cap assembly, and a retaining system arranged to hold the static cap assembly while the magnetic component is magnetically coupled to the electromagnetic array, and wherein the outer housing is configured to engage the one or more of the external contact pad areas, V- grooves, and retaining system to hold the static cap assembly without rotation with respect to the active device, thereby magnetically coupling the magnetic component to the electromagnetic array and enabling the spin chamber to spin with respect to the active device and the outer housing when the electromagnetic array is actuated.

[0034] The magnetic components can include a permanent magnet array.

[0035] In another aspect, the passive devices described herein can include a spin chamber including a housing defining an interior hollow chamber, and a first magnetic component connected to the housing.

[0036] Embodiments can include one or any combination of two or more of the following features.

[0037] The systems cam further include a static cap assembly rotatably connected to a top of the spin chamber housing, wherein the static cap assembly includes one or more of: external contact pad areas including anti-slip padding, V-grooves equally distributed around a perimeter of the static cap assembly, and a pattern of holes on a top of the static cap assembly, and wherein first magnetic component includes a circular array of magnets integrated into a floor of the housing opposite the top of the housing.

[0038] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials aredescribed below. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

[0039] Various embodiments of the features of this disclosure are described herein. However, it should be understood that such embodiments are provided merely by way of example, and numerous variations, changes, and substitutions can occur to those skilled in the art without departing from the scope of this disclosure. It should also be understood that various alternatives to the specific embodiments described herein are also within the scope of this disclosure.Other features and advantages of the invention will be apparent from the following detailed description, and from the claims.DESCRIPTION OF DRAWINGS

[0040] FIG. l is a schematic view of a sterile drive system and a spin chamber.

[0041] FIG. 2 is a schematic view of a spin chamber with a magnetically coupled drive system.

[0042] FIG. 3 is a cross-section of a spin chamber with a magnetically coupled drive system.

[0043] FIG. 4 is a top view of the spin chamber of FIG. 3.

[0044] FIGS. 5 A and 5B are a schematic view of the spin chamber of FIG. 3 and a cross-section of the spin chamber, respectively.

[0045] FIG. 6 is a schematic diagram of an instrument side of the magnetically coupled drive system.

[0046] FIG. 7 is a schematic view of an imaging device arranged to capture images of a spin chamber.

[0047] FIG. 8 is a schematic diagram of a spin chamber and instrument side with an electro- magnetically coupled drive system.

[0048] FIG. 9 is a deconstructed view of the spin chamber and instrument side of FIG. 8.

[0049] FIG. 10 is another deconstructed view of the spin chamber and instrument side of FIG. 8.

[0050] FIG. 11 is a bottom view of a portion of the instrument side of FIG. 8.

[0051] FIG. 12 is an example of a workflow that can be implemented using drive systems as described herein.DETAILED DESCRIPTION

[0052] The present disclosure provides devices, systems, and methods for imparting rotational motion using drive systems that do not require a mechanical coupling. The drive systems can be used with spin chambers, e.g., centrifuge chambers or centrifuge cartridges. For example, the drive system can impart rotational motion to contents (e.g., liquid contents) of a spin chamber using magnetic and / or electro-magnetic fields without compromising sterility of the contents.Sterile Drive Systems

[0053] FIG. 1 illustrates an example of a spin chamber 100 including a passive drive unit 102. The passive drive unit 102 is coupled to an active drive unit 104, which imparts rotational motion to the passive drive unit 102. In general, the passive drive unit 102 is not mechanically coupled to the active drive unit 104. The passive drive unit 102 and active drive unit 104 form a coupling interface 106, e.g., without mechanical couplings. This can be advantageous, e.g., to provide sterility within the spin chamber 100. For example, the passive drive unit 102 can be coupled to the active drive unit 104 using magnetic and / or electro-magnetic fields. In some implementations, the passive drive unit 102 is connected to the spin chamber 104 such that rotation of the passive drive unit 106 rotates the spin chamber 100. The active drive unit 104 can be controlled to rotate the coupled passive drive unit 102, to perform specific centrifugation protocols.Magnetically Coupled Drive Systems

[0054] FIG. 2 illustrates an example of a spin chamber 200 magnetically coupled to an instrument 202 using a magnetically coupled drive system 204. The spin chamber 200 can be, for example, a disposable spin chamber that is part of a consumable used in a biological process (e.g., a cell-therapy consumable). The spin chamber 200 can include a passive drive unit 206, which forms a passive portion of the magnetically coupled drive system 204. In some implementations, a magnetic component (e.g., a magnetic bar) within the spin chamber can rotate. In some implementations, the spin chamber itself can rotate. The instrument 202 can be part of a system that utilizes the consumable. The instrument 202 can include an active drive unit 208, which forms an active portion of the magnetically coupled drive system 204. Some examples of instruments that can use a spin chamber similar to the spin chamber 200 include celltherapy centrifuges (e.g., cell separation / washing centrifuges), spin-coaters or other rotary automation centrifuges, and impeller / propeller drivers (e g., for electric submersibles).

[0055] The spin chamber 200 and the instrument 202 can be magnetically coupled to one another through the magnetic coupling interface 204. The magnetic coupling interface 104 includes e.g., the magnetic components that couple the spin chamber 200 and the instrument 202. The active drive unit 208 of the instrument 202 can rotate the passive drive unit 206 via the magnetic coupling interface 204. In some implementations, the passive drive unit 206 is connected to the spin chamber 200 such that rotation of the passive drive unit 206 rotates the spin chamber 200. The active drive unit 208 can be connected to a motor 210 (e.g., a stepper motor, a direct current (DC) motor, a brushless direct current (BLDC) motor, etc.) to rotate the active drive unit 208. The motor 210 can be controlled to rotate the active drive unit 208, and thereby the magnetically coupled passive drive unit 206, to perform processes, such as a biological process. In some implementations, the spin chamber 200 can include temperature controls, e.g., to maintain the viability of cells during centrifugation.

[0056] FIG. 3 illustrates a cross-section of a centrifuge side 300, e.g., of a cell-therapy manufacturing consumable or other consumable. The centrifuge side 300 can be magnetically coupled to an instrument side 302, e.g., of a system that utilizes the consumable to perform a biological process, e.g., size-based separation of cells in a liquid medium. The centrifuge side 300 can be magnetically coupled to the instrument side 302 via a magnetic coupling interface 324 The centrifuge side 300 can include a spin chamber 304 that can function as a centrifuge. The spin chamber 304 is described in further detail below with reference to FIGS. 5A and 5B.

[0057] A housing 306 of the spin chamber 304 can include a magnetic component 308 (e.g., a magnetic disk or ring). In some implementations, the magnetic component 308 is connected to a bottom of the housing 306, e.g., the magnetic component 308 can be integrated into the bottom of the housing 306. The magnetic component 308 can magnetically couple the spin chamber 304 to the instrument side 302. In some implementations, a static cap assembly 310 can be rotatably connected to a top of the housing 306 opposite the bottom of the housing 306. One or more retention brackets 312 can attach to the static cap assembly 310, e.g., via a friction fit, to retain and constrain the static cap assembly 310 while the spin chamber 304 rotates. Retaining the static cap assembly 310 can prevent the spin chamber 304 from disconnecting from the instrument side 302 during rotation. In some implementations, the retention brackets 312 can include acounterbore feature, e.g., so that a jam nut can be installed to retain the static cap assembly 310. In some implementations, the static cap assembly 310 can be formed by two parts that are rigidly connected to one another. In some implementations, the static cap assembly 310 can be formed by more or fewer parts. The static cap assembly 310 can be connected to the top of the housing 306, for example by a bearing 322.

[0058] In some implementations, the spin chamber 304 can include a fluidic interface 314 (e.g., through the static cap assembly 310) to introduce, extract, and / or provide access to the fluid contained within the spin chamber 304 (e.g., prior to rotation of the spin chamber 304, during rotation of the spin chamber 304, and / or after rotation of the spin chamber 304). For example, the fluidic interface 314 can include a fluidic compression fitting interface. In some implementations, the fluidic interface 314 can be fluidly connected to a pump (e.g., a peristaltic pump) that can fill or aspirate the fluidic interface 314 to remove fluid from or add fluid to the spin chamber 304.

[0059] The instrument side 302 can include an active drive magnetic component 316 (e.g., a magnetic disk or ring) that can magnetically couple to the passive magnetic component 308. In some implementations, the active drive magnetic component 316 can be similar to the magnetic component 308. In other implementations, the active drive magnetic component 316 and the passive magnetic component 308 can be different from one another. The active drive magnetic component 316 can be connected to a driveshaft 318 (e.g., via a thrust bearing, an axial retention bearing, etc.). The driveshaft 318 can be connected to a motor 320 (e.g., a stepper motor, hybrid stepper motor, or brushless DC motor) that can rotate the driveshaft 318. Due to the magnetic coupling between the active drive magnetic component 316 and the passive magnetic component 308, rotation of the driveshaft 318 can translate to rotation of the spin chamber 304, e.g., at approximately a 1 :1 ratio. In some implementations, the rotation of the driveshaft 318 can translate to rotation of the spin chamber 304 at less than a 1 : 1 ration, e.g., due to friction, slight manufacturing defects, and / or other inefficiencies. Using magnetic coupling to rotate the spin chamber 304 can allow for rotation of the spin chamber without compromising sterility of its contents, e.g., liquid contents within the spin chamber. Maintaining sterility of the contents within a spin chamber can be important for a centrifugation process.

[0060] In some implementations, brackets (e.g., retention brackets 312) can secure the spin chamber of the centrifuge side 300 to the instrument side 302. For example, securing the spin chamber 304 to the instrument side 302 can position and arrange the passive magnetic component 308 and the active drive magnetic component 316 such that the passive magnetic component 308 and the active drive magnetic component 316 are aligned to magnetically couple to one another. The spacing between the passive magnetic component 308 and the drive magnetic component 316 can allow for magnetic attraction so that spinning the active drive magnetic component 316 imparts rotational motion to the passive magnetic component 308.

[0061] FIG. 4 illustrates a top view of the spin chamber 304 of FIG. 3. The top of the spin chamber 304 can include holes (e.g., 402a, 402b, 402c, 402d, 402e, 402f). Connectors (e.g., screws bolts, etc.) can be inserted through the holes to connect the top half of the spin chamber 304 to the bottom half of the spin chamber 304. In some implementations, the spin chamber 304 can include more or fewer holes than shown in FIG. 4. In some implementations, the spin chamber 304 can include counterweights to balance the spin chamber 304.

[0062] In FIG. 4, the static cap assembly 310 is shown on the top of the spin chamber 304. The static cap assembly 310 can include contact pad areas (e.g., 400a, 400b, 400c) configured to come into contact with retention brackets, e.g., similar to the retention brackets 312 of FIG. 3. In some implementations, the contact pad areas and / or the retention brackets can include anti-slip padding to reinforce the contact between the contact pad areas and the retention brackets. In some implementations, the static cap assembly 310 can include a kinematic mount (e.g., a Maxwell kinematic mount), e.g., using ball-vee contacts (e.g., 404a, 404b, 404c) that interact with the retention brackets. The kinematic mount can include V-shaped grooves on the static cap (e.g., 404a, 404b, 404c) that can be oriented at the outer edge of the top of the static cap assembly 310, while the mating parts (e.g., in the form of ball bearings) can be arranged on the bottoms of the respective retention brackets. These three ball contacts can sit in the grooves. This symmetrical design is easy to manufacture and may provide precise support for the static cap. The kinematic mount can be thermally stable due to the symmetrical arrangement as the curved surfaces (balls) can expand or contract in unison in the V-grooves.

[0063] In some implementations, the ball-vee contacts (e.g., 404a, 404b, 404c) can be threaded. The static cap assembly 310 can include a pattern of tapped holes (e.g., 406a, 406b, 406c, 406d, 406e, 406f) that can interact with the retention brackets. In some implementations, the tappedholes (e.g., 406a, 406b, 406c, 406d, 406e, 406f) can be threaded. Each of the contact pads, the ball-vee contacts, and the tapped holes may improve and secure the connection between the static cap assembly 310 and the retention brackets.

[0064] FIGS. 5A and 5B show a schematic side view of the spin chamber 304 of FIG. 3 and a cross-section of the spin chamber 304, respectively. As discussed herein, the static cap assembly 310 can be rotatably attached to the top of the spin chamber 304, such that, when the spin chamber 304 rotates, the static cap assembly 310 does not rotate. The spin chamber 304 can include a chamber bottom 500 connected to a chamber top 502 to form a sealed (e g., watertight) connection. The chamber bottom 500 can be connected to a center shaft 512. The center shaft 512 can include a central longitudinal conduit for fluids, of the chamber static cap assembly 310, via a threaded seal 510, which can include one or more O-rings. The central longitudinal conduit enables the transfer of fluids into and out of the spin chamber 304. The O-rings seal the connections between the components to reduce leakage. In some implementations, the contact area between a raised central receiver rising from the chamber bottom 500 and the center shaft 512 can be tapered so that the center shaft 512 self-centers with the center of the raised central receiver of the chamber bottom 500. This can be helpful, e g., to more easily insert the spin chamber 304 into the chamber. In some implementations, the chamber bottom 500 can be connected to the chamber top 502 via connectors (e.g., screws, bolts, etc.) through the holes (e.g., 402a, 402b, 402c, 402d, 402e, 402f) shown in FIG. 4 (and can include an O-ring 513). In some implementations, the spin chamber 304 can be formed of a single piece (e.g., via injection molding). In some implementations, the spin chamber 304 can be formed via multiple machined parts to increase stiffness / robustness.

[0065] As shown in FIG. 5B, the chamber bottom 500 can include a distribution layer 504 that provides a fluidic channel. This arrangement enables fluid to flow through the fluidic interface 314 at the top of the static cap assembly 310, through the conduit within the center shaft 512 to the distribution layer. The distribution layer can direct the fluid horizontally through the fluidic channel of the distribution layer 504 to the circumference of the chamber bottom 500, allowing fluid to enter the internal hollow chamber within the spin chamber 502 through opening 515.

[0066] In some implementations, fluid can be added to, or extracted from, the spin chamber through a single fluidic path. For example, fluid can be introduced, or extracted, via the fluidic interface 314. The fluid can travel through the central axis of the center shaft 512 and the fluidicchannel of the distribution layer 504 to, or from, the periphery of the spin chamber. The fluid can enter, or exit, the spin chamber through the opening 515.

[0067] In some implementations, the fluidic interface 314 includes a single channel which empties into the periphery of the spin chamber. In other implementations, the number of channels can vary. For example, the fluidic interface can include multiple channels that each empty into the periphery of the spin chamber.

[0068] In some implementations, the chamber bottom 500 can include one or more retention fins, for example to retain and preserve pellets. For example, the chamber bottom 500 can include retention fins near the opening 515. The contour of the chamber bottom 500 can be designed to balance load and receive desired fluid volumes. For example, the interior of the chamber bottom 500 can include a curved profile to address various radial portions of the fluid.

[0069] In some implementations, the chamber top 502 can be connected to the static cap assembly 310 via a bearing 506 that allows the spin chamber 304 to rotate relative to the static cap assembly 310. A rotary shaft seal 408 can be included within the static cap assembly 310 to prevent (or minimize) fluid from leaking through the static cap assembly 310. The rotary shaft seal 508 can include a low friction component, such as elastomer seals impregnated with materials such as Delrin, teflon, or similar materials.

[0070] FIG. 6 is a schematic diagram of an instrument side 600, e.g., of an instrument configured to receive a consumable in the form of a spin chamber (not shown). In some implementations, the instrument side 600 can be similar to the instrument side 302 of FIG. 3. The instrument side 600 can include a drive magnetic component 602 (e.g., a magnetic disk or ring) that can magnetically couple to a passive magnetic component of a spin chamber, as discussed herein. The drive magnetic component 602 can include magnetic elements (e.g., 604a, 604b, 604c, 604d). In some implementations, the magnetic elements can be equally distributed around the drive magnetic component 602. In some implementations, the drive magnetic component 602 can include more or fewer magnetic elements than shown in FIG. 6, or the entire drive component may be magnetized. The drive magnetic component 602 can be operatively connected to a driveshaft 606, e.g., via a bearing 608 (e.g., a thrust bearing, an axial retention bearing, etc.). The driveshaft 606 can be connected to a motor 610 (e.g., a stepper motor) that can rotate the driveshaft 606 and thereby the drive magnetic component 602. In someimplementations, the instrument side 600 can include one or more sensors, including but not limited to fluidic sensors, accelerometers, and cameras to monitor centrifugation.

[0071] FIG. 7 is a schematic view of an imaging device 700 configured to capture images of a spin chamber 702 on an instrument 704. The imaging device 700 can include, e.g., a camera, a spectrometer, a microscope, a turning mirror, etc. The housing of the spin chamber 702 can be transparent or translucent to allow the imaging device 700 to monitor the fluid within the spin chamber 702. In implementations without an imaging device 700, the spin chamber 702 can be opaque. The imaging device 700 can be used to monitor the fluid before rotation of the spin chamber 702, during rotation of the spin chamber 702, and / or after rotation of the spin chamber 702. The imaging device 700 can process optical data, e.g., via spectrometry, optical analysis, etc., during a biological process. In other implementations, the imaging device 700 can be positioned to monitor different portions of the spin chamber 702.Electro-Magnetically Coupled Drive Systems

[0072] FIG. 8 is a schematic diagram of a spin chamber 800 that is electro-magnetically coupled to an instrument or base 802. In some implementations, the spin chamber 800 can be similar to, e.g., the spin chamber 204 of FIG. 2. In some implementations, an outer housing 806 can include the spin chamber 800 and can retain the spin chamber 800 relative to the instrument or base 802. For example, the outer housing 806 can retain a static cap assembly 810 that holds the spin chamber 800 in place. In some implementations, the housing 806 can function similar to the retaining brackets of FIG. 2. In some implementations, the static cap assembly 810 can be similar to the static cap assembly 204 of FIG. 3. The spin chamber 800 can include a magnetic component 804 (e.g., a magnetic disk or ring), e.g., similar to the magnetic component 208 of FIG. 1. In some implementations, the outer housing 806 can include retention features (e.g., similar to the retention features 310, 312, 314 to retain the static cap assembly 810.

[0073] In some implementations, the instrument or base 802 includes an electromagnet array 808 (e.g., an axial flux motor) that can magnetically couple to the magnetic component 804. A controller (not shown) can be arranged and programmed to selectively power portions of the electromagnet array 808 to cause the magnetic component 804 (and thus the spin chamber 204) to rotate. For example, portions of the electromagnet array can selectively be powered on and off to attract corresponding portions of the magnetic component 804 in a pattern that causes themagnetic component 804 to rotate. As discussed herein, using the disclosed drive systems to rotate the spin chamber 808 allows for rotation of the spin chamber without compromising sterility of its contents, e.g., liquid contents within the spin chamber, e.g., for centrifugation.

[0074] FIG. 9 is a deconstructed view of the spin chamber 800 and an instrument or base 802 of FIG. 8. The electromagnet array 808 is shown in more detail in FIG. 9. As shown, the electromagnet array 808 can have a number of electromagnetic elements (e.g., 808a, 808b, 808c, 808d), for example, positioned in a circular fashion. Although Fig. 9 shows sixteen electromagnetic elements, the electromagnet array 808 can include any number of electromagnetic elements. In some implementations, each of the electromagnetic elements can be selectively powered on or off (e.g., by a controller) to selectively attract or repel a portion (e.g., a magnetic element) of the magnetic component 804 of the spin chamber 800. The electromagnetic elements can be selectively powered on or off in a pattern that causes the magnetic component 804, and thereby the spin chamber 800, to rotate. One or multiple hall sensors can be used (not shown) to synchronize the power to the electromagnets to the relative position of the permanent magnets within the spin chamber to create a defined phase angle between the electromagnetic field created by the electromagnets and the permanent magnets of the spin chamber. Using an electromagnet array that is selectively controllable can reduce the number of moving parts in the instrument or base. For example, the instrument or base 802 may not require a driveshaft or motor.

[0075] FIG. 10 is another deconstructed view of the spin chamber 800 and the instrument or base 802 of FIG. 8. The magnetic component 804 of the spin chamber 800 can include a circular array of permanent magnets. In some implementations, the magnetic component 804 can include a number of permanent magnets that corresponds to the number of electromagnetic elements in the electromagnet array 808. In some implementations, the magnetic component 804 can include more or fewer permanent magnets than the number of electromagnetic elements in the electromagnet array 808. In some implementations, the magnetic component 804 can include a second electromagnetic array including electromagnetic elements. In some implementations, the electromagnet array 808 can be seated in a circular opening 811 in the instrument or base 802.

[0076] FIG. 11 is a bottom view of the instrument or base 802 of FIG. 8. The spin chamber 804 can be positioned in the circular opening 811 of the instrument or base 802, which secures or “nests” the spin chamber 804 in the circular opening 811 of the instrument or base 802. Forexample, nesting or coupling the spin chamber 804 into the circular opening 811 of the instrument or base 802 can position and arrange the magnetic component 804 of the spin chamber 800 and the electromagnet array 808 of the instrument or base 802 such that the magnetic component 804 and the electromagnet array 808 are aligned and the spacing between the magnetic component 804 and the electromagnet array 808 allows for an appropriate level of electromagnetic attraction to rotate the magnetic component 804.Methods of Using Sterile Centrifuge Drive Systems

[0077] The drive systems described herein can be used for a variety of cartridge-based assays and protocols. Fig. 12 shows an example of a cell run workflow 1200 that can be implemented using sterile centrifuge drive systems as described herein. The cell run workflow 1200 separates particles, e.g., cells, within fluid samples by density. The cell run workflow 1200 can include loading a sample into a spin chamber (1202). The spin chamber can be inserted into, or connected to, an instrument capable of executing a cell run workflow (e.g., an automated instrument). The spin chamber can be rotated using drive systems as described herein. The centrifugation rotation speed of the spin chamber can be increased to reach certain revolutions per minute (rpm) (1204). The spin chamber can be rotated at the centrifugation speed for a certain time period to centrifuge the sample within the spin chamber (1206). During this time period, the spin chamber (and the sample) can be monitored, e.g., by an imaging system for a visual or automated quality control review, e.g., reviewing pelleting and / or supernatant clarity (1208). The rotation speed can be reduced to a slower speed (1210).

[0078] The workflow can include depleting material from the spin chamber, e.g., offboarding waste from the spin chamber (1212). The waste can be characterized to determine information about the centrifugation, e.g., for quality control. For example, a cell count of the waste can provide insight into the status of the centrifugation. If a significant number of cells appear in the waste product, the separation may not have occurred properly. Wash buffer (e.g., phosphate buffered saline (PBS), Ethylenediaminetetraacetic acid (EDTA), etc.) can be added to the spin chamber after the waste is offboarded (1214). The amount of wash buffer added may depend on the residual volume of a sample within the spin chamber. The sample can be resuspended in the wash buffer (1216).

[0079] The rotation speed of the spin chamber can be increased (e.g., to the centrifugation speed) (1218). The spin chamber can be rotated at the centrifugation speed for a certain time (1220). In some implementations, the cycle of slowing down the speed, offloading the waste, adding washing buffer, and increasing the rotation speed can be repeated multiple times (1222). Repeatedly offloading waste and adding wash buffer may improve recovery of low volume samples. The rotation speed of the spin chamber can be reduced to a stop (1224). The spin chamber can remain stopped for a time period that allows the sample to settle and resuspend in the spin chamber (1226).

[0080] In some implementations, a volume of the sample can be adjusted after recovery of the desired end product particles, e.g., cells (1228). For example, if the desired product is a specific concentration of cells, the volume of the sample can be adjusted by adding or subtracting wash buffer to change the cell concentration. The sample can be recovered from the spin chamber (1230). In some implementations, the sample can be tested for further processes. For example, the sample can be tested for the yield and viability of the sample for further processes. In some implementations, the sample can be tested under a microscope and / or automatically by another portion of the instrument.OTHER EMBODIMENTS

[0081] While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any inventions or of what may be claimed, but rather as descriptions of features specific to particular implementations of particular inventions. Certain features that are described in this specification in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or variation of a subcombination.

[0082] Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular ordershown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described program components and systems can generally be integrated together in a single software product or packaged into multiple software products.

[0083] Thus, particular implementations of the subject matter have been described. Other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. In addition, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results. In certain implementations, multitasking and parallel processing may be advantageous.

Claims

WHAT IS CLAIMED IS:

1. A system comprising:(a) a passive device comprising: a spin chamber comprising: a housing defining an interior hollow chamber, and a passive magnetic component connected to the housing; and(b) an active device comprising: an active magnetic and / or electromagnetic component configured to magnetically couple to the passive magnetic component, wherein when the passive magnetic component and the active magnetic and / or electromagnetic component are magnetically coupled, the active magnetic and / or electromagnetic component causes rotation of the spin chamber while maintaining sterility within the spin chamber.

2. The system of claim 1, wherein the driving device comprises a base, and wherein the active magnetic and / or electromagnetic component comprises a circular electromagnetic array arranged around a circular opening of the base and configured to electromagnetically couple to the passive magnetic component when the passive magnetic component is nested in the circular opening, wherein the electromagnetic array is configured and electronically controlled to generate one or more electromagnetic fields that cause the spin chamber to rotate with respect to the base when the passive magnetic component of the passive device is nested in the circular opening of the base.

3. The system of claim 1 or claim 2, wherein the active magnetic and / or electromagnetic component comprises an active magnetic component configured to magnetically couple to the passive magnetic component, wherein when the passive magnetic component and the active magnetic component are coupled, rotation of the active magnetic component causes rotation of the passive magnetic component while maintaining sterility within the spin chamber.

4. The system of any one of claims 1 to 3, further comprising: a static cap assembly rotatably connected to a top of the spin chamber housing, wherein the static cap assembly comprises one or more of:(i) external contact pad areas comprising anti-slip padding;(ii) V-grooves equally distributed around a perimeter of the static cap assembly; and(iii) a pattern of holes on a top of the static cap assembly.

5. The system of claim 4, wherein the static cap assembly further comprises a fluidic interface configured to flow fluid into and out of the interior hollow chamber within the spin chamber.

6. The system of claim 4, further comprising: retention brackets configured to connect to and retain the static cap assembly via an interaction with the one or more of the (i) external contact pad areas, (ii) V-grooves, and (iii) pattern of holes, to retain the static cap assembly without rotation with respect to the active device, thereby magnetically coupling the passive magnetic component to the active magnetic component and enabling the spin chamber to spin with respect to the retention brackets of the active device.

7. The system of claim 4, wherein the static cap assembly is connected to the housing by a bearing.

8. The system of any one of claims 1 to 7, wherein the housing comprises counterweights integrated into the wall of the housing and configured to balance the spin chamber during rotation of the spin chamber.

9. The system of any one of claims 1 to 8, wherein the interior of the housing comprises a contoured surface to balance liquid loads and to receive desired fluid volumes.

10. The system of any one of claims 1 to 8, wherein the interior of the housing includes a distribution layer and fluid conduit configured to allow fluid to flow to the periphery of the interior hollow chamber.11 . The system of any one of claims 1 to 10, wherein the interior of the housing includes one or more retention fins.

12. The system of any one of claims 1 to 11, wherein the active magnetic and / or electromagnetic component comprises a magnetic component configured to magnetically couple to the passive magnetic component.

13. A system comprising:(a) a passive device comprising: a spin chamber comprising: a housing defining an interior hollow chamber, and a first magnetic component connected to the housing; and(b) an active device comprising: a second magnetic component configured to magnetically couple to the first magnetic component, wherein when the passive device and the active device are coupled, rotation of the second magnetic component causes rotation of the first magnetic component while maintaining sterility within the spin chamber.

14. The system of claim 13, further comprising: a static cap assembly rotatably connected to a top of the spin chamber housing, wherein the static cap assembly comprises one or more of:(i) external contact pad areas comprising anti-slip padding;(ii) V-grooves equally distributed around a perimeter of the static cap assembly; and(iii) a pattern of holes on a top of the static cap assembly.

15. The system of claim 14, wherein the static cap assembly further comprises a fluidic interface configured to flow fluid into and out of the interior hollow chamber within the spin chamber.

16. The system of claim 14 or claim 15, further comprising:retention brackets configured to connect to and retain the static cap assembly via an interaction with the one or more of the (i) external contact pad areas, (ii) V-grooves, and (iii) pattern of holes, to retain the static cap assembly without rotation with respect to the active device, thereby magnetically coupling the first magnetic component to the second magnetic component and enabling the spin chamber to spin with respect to the retention brackets of the active device when the motor is actuated.

17. The system of any one of claims 14 to 16, wherein the static cap assembly is connected to the housing by a bearing.

18. The system of any one of claims 13 to 17, wherein the housing comprises counterweights integrated into the wall of the housing and configured to balance the spin chamber during rotation of the spin chamber.

19. The system of any one of claims 13 to 18, wherein the interior of the housing comprises a contoured surface to balance liquid loads and to receive desired fluid volumes.

20. The system of any one of claims 13 to 18, wherein the interior of the housing includes a distribution layer and fluid conduit configured to allow fluid to flow to the periphery of the interior hollow chamber.

21. The system of any one of claims 13 to 20, wherein the interior of the housing includes one or more retention fins.

22. A system comprising:(a) a passive device comprising: an outer housing; a spin chamber arranged within the outer housing and comprising: a housing defining an interior hollow chamber, and a magnetic component connected to the spin chamber housing; and(b) an active device comprising:a base comprising an opening within which the magnetic component of the spin chamber can nest and rotate; and an electromagnetic array arranged around the opening of the base and configured to magnetically couple to the magnetic component when the magnetic component is nested in the opening, wherein the electromagnetic array is configured and electronically controlled to generate one or more electromagnetic fields that cause the spin chamber to rotate with respect to the base and to the outer housing when the magnetic component of the passive device is nested in the opening of the base.

23. The system of claim 22, further comprising: a static cap assembly rotatably connected to a top of the spin chamber housing, wherein the static cap assembly is retained within the outer housing such that the static cap assembly does not rotate with respect to the outer housing and the spin chamber can rotate with respect to the outer housing.

24. The system of claim 23, wherein the static cap assembly comprises one or more of:(i) a plurality of external contact pad areas comprising anti-slip padding;(ii) a plurality of V-grooves equally distributed around a perimeter of the static cap assembly; and(iii) a retaining system arranged to hold the static cap assembly while the magnetic component is magnetically coupled to the electromagnetic array; and wherein the outer housing is configured to engage the one or more of the (i) external contact pad areas, (ii) V-grooves, and (iii) retaining system to hold the static cap assembly without rotation with respect to the active device, thereby magnetically coupling the magnetic component to the electromagnetic array and enabling the spin chamber to spin with respect to the active device and the outer housing when the electromagnetic array is actuated.

25. The system of any one of claims 22 to 24, wherein the magnetic component comprises a permanent magnet array.

26. A passive device comprising: a spin chamber comprising: a housing defining an interior hollow chamber, and a first magnetic component connected to the housing.

27. The passive device of claim 26, further comprising: a static cap assembly rotatably connected to a top of the spin chamber housing, wherein the static cap assembly comprises one or more of:(i) external contact pad areas comprising anti-slip padding;(ii) V-grooves equally distributed around a perimeter of the static cap assembly; and(iii) a pattern of holes on a top of the static cap assembly; and wherein first magnetic component comprises a circular array of magnets integrated into a floor of the housing opposite the top of the housing.

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