Communication control and operation control of the apheresis system

Abstract

The method includes detecting activation of an apheresis device, transmitting data to a server in response to the detection of the activation, determining whether the software of the apheresis device is up to date based on the data, receiving a response from the server in response to the data, and disabling use of the apheresis device if the response indicates that the software is not up to date. The data transmitted to the server includes one or more of a data log, a firmware version identifier, and an error log. The response includes a lockout signal. The response includes a software update. The software update includes a firmware update. The method further includes automatically initiating installation of the software update. The method further includes ending the disabling state of the apheresis device after installing the software update.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 18 / 116,988, filed March 3, 2023, which claims the benefit of U.S. Provisional Patent Application No. 63 / 318,683, filed March 10, 2022. The entire disclosure of the above application is incorporated herein by reference.

[0002] The present disclosure relates to communication and operational control of an apheresis system. [Background technology]

[0003] This section provides background information related to the present disclosure that is not necessarily prior art.

[0004] There are two commonly known methods for donating / collecting blood. The first common method is receiving whole blood donations from donors. Once whole blood is obtained, blood components can be separated from the whole blood using a centrifugation process, for example, based on the density of different blood components. The desired components can be transferred to a collection container manually, semi-automatically, or automatically during and / or after the application of centrifugal force. The second common method is called apheresis collection, which requires specialized equipment. For example, in the apheresis method, whole blood is extracted from a donor while the donor is connected to a specialized apheresis machine. The whole blood is then centrifuged to collect only the desired blood component (e.g., plasma), and all other blood components are returned to the donor during the same blood donation connection or cycle. The donor is connected to the apheresis machine during the separation and collection of blood components. Summary of the Invention [Problem to be solved by the invention]

[0005] However, the apheresis process has the disadvantage of being time-consuming and uncomfortable for the donor. For example, donors often must remain connected to a dedicated apheresis machine for an hour or more to donate blood components. Therefore, there is a need to develop processes and improve dedicated apheresis machines to improve the comfort and efficiency of the blood component donation procedure. [Means for solving the problem]

[0006] This section provides a general overview of the disclosure and is not an exhaustive disclosure of the entire scope or all features.

[0007] There is a need for a plasma or other blood component system that can shorten donation time and increase donor comfort. The embodiments provided herein can increase the efficiency of the blood collection process by using separated blood components to push or shove unintended blood components back to the donor without stopping and restarting a centrifuge. For example, in at least one exemplary embodiment, the present disclosure provides methods and devices for positioning a disposable portion (e.g., a loop) within, e.g., a medical device. In at least one exemplary embodiment, the present disclosure provides a system, e.g., including a surface, for automatically guiding the loop. In at least one exemplary embodiment, the present disclosure provides a medical device, e.g., including a blood separation device, e.g., an apheresis device.

[0008] In at least one exemplary embodiment, the present disclosure provides an assembly for separating components from a multi-component fluid. The assembly includes a filler and a loop rotation position guide. The filler includes a channel for holding a disposable separation bladder. The channel includes two opposing walls. The loop rotation position guide includes a plurality of bearings. The loop rotation position guide holds a flexible loop of the disposable when the separation bladder is loaded into the bladder channel. In at least one exemplary embodiment, the loop rotation position guide may include a stop plate. In at least one exemplary embodiment, the flexible loop may contact the stop plate when held within the loop rotation position guide. In at least one exemplary embodiment, the assembly may be part of an apheresis device. In at least one exemplary embodiment, the assembly may be connected to a rotor that rotates the loop rotation position guide about an axis of rotation. In at least one exemplary embodiment, the plurality of bearings may include pairs of roller bearings.

[0009] In at least one exemplary embodiment, the present disclosure provides a centrifuge assembly. The centrifuge assembly includes a centrifuge housing having an outer surface and an internal cavity. The centrifuge housing rotates about a rotational axis of the centrifuge assembly. The centrifuge assembly includes a fluid separation body at least partially disposed within the internal cavity of the centrifuge housing. The fluid separation body is configured to rotate relative to the centrifuge housing about the rotational axis of the centrifuge assembly. The centrifuge assembly includes a fluid line loop arm attached to a portion of the centrifuge housing and extending along the length of the outer surface of the centrifuge housing. The fluid line loop arm includes a bearing set disposed at a point along the length of the outer surface, the bearing set configured to contact tubing portions of interconnected fluid line loops to hold the fluid line loops in an engaged position relative to the centrifuge housing while allowing the fluid line loops to rotate in the engaged position. In at least one exemplary embodiment, the bearing set may include a pair of roller bearings. In at least one exemplary embodiment, the bearing set may include multiple pairs of roller bearings. In at least one exemplary embodiment, the centrifuge assembly may be part of an apheresis device. In at least one exemplary embodiment, the fluid line loop is attached at a first end of the fluid line loop to a stationary, non-rotating portion of the apheresis device via a first positively-located connector, and at a second end of the fluid line loop, the fluid line loop is interconnected to the fluid separation body within the internal cavity via a second positively-located connector. In at least one exemplary embodiment, the second end of the fluid line loop may rotate with the fluid separation body. In at least one exemplary embodiment, the fluid line loop may be physically and fluidly attached to a disposable fluid separation bladder at the second positively-located connector.In at least one exemplary embodiment, the fluid line loop may include multiple lumens. In at least one exemplary embodiment, the fluid isolation bladder may comprise a first flexible sheet attached to a second flexible sheet to form a fluid pathway, and a first portion of the fluid pathway may be narrower than a second portion of the fluid pathway.

[0010] In at least one exemplary embodiment, the present disclosure provides a method for automatically loading a fluid line loop into a centrifuge assembly. The method includes attaching the fluid line loop at a first end to a fluid separation body of the centrifuge assembly and rotating the fluid separation body in a first rotational direction relative to a housing of the centrifuge assembly, whereby rotating the fluid separation body rotates the fluid line loop relative to the housing and guides it into a channel of a loop arm attached to a portion of the housing. The channel includes a bearing disposed in a bearing set attached to the loop arm. The bearing holds the fluid line loop in a predetermined position relative to the housing as the centrifuge assembly rotates. In at least one exemplary embodiment, the bearing may contact a portion of the fluid line loop as the fluid line loop rotates in the predetermined position within the channel relative to the housing. In at least one exemplary embodiment, the centrifuge housing may rotate in a first rotational direction about an axis of rotation at a first angular velocity, and the fluid separation body may rotate at a different second angular velocity about the axis of rotation due to a torsional force imparted by the fluid line loop. In at least one exemplary embodiment, the second angular velocity may be approximately twice the first angular velocity. In at least one exemplary embodiment, the fluid line loop may be physically and fluidly attached to a disposable fluid separation bladder at least partially disposed within the fluid separation body. In at least one exemplary embodiment, the method further includes attaching a second end of the fluid line loop to a rotationally fixed point on an apheresis device and rotating the centrifuge assembly (e.g., via a rotor-motor assembly of the apheresis device) about the axis of rotation relative to the rotationally fixed point on the apheresis device.

[0011] In at least one exemplary embodiment, the present disclosure provides a method for collecting blood components through apheresis, comprising: drawing whole blood from a donor into a centrifuge; rotating the centrifuge to apply centrifugal force to the whole blood and separate the whole blood into at least a first blood component and a third blood component; separating the first blood component from the whole blood; extracting the first blood component into a container; detecting that a second blood component has been extracted; and, after the second blood component is detected, returning the separated first blood component to the centrifuge while the centrifuge continues to rotate, and removing at least the third blood component from the centrifuge and returning it to the donor. In at least one exemplary embodiment, the first blood component may include one or more of plasma, platelets, red blood cells, and / or high-hematocrit blood. In at least one exemplary embodiment, the second blood component may include one or more of plasma, platelets, red blood cells, and / or high hematocrit blood. In at least one exemplary embodiment, the third blood component may include one or more of plasma, platelets, red blood cells, and / or high hematocrit blood. In at least one exemplary embodiment, the first blood component may include two or more of plasma, platelets, red blood cells, and / or high hematocrit blood. In at least one exemplary embodiment, the centrifuge may rotate at a first speed when separating the first blood component from the whole blood. In at least one exemplary embodiment, the centrifuge may continue to rotate at the first speed when returning the separated first blood component to the centrifuge. In at least one exemplary embodiment, the centrifuge may rotate at a second speed when drawing whole blood from the donor into the centrifuge. In at least one exemplary embodiment, the second speed may be slower than the first speed. In at least one exemplary embodiment, the first blood component may comprise a blood component separated from the whole blood in a blood component collection set inserted into the centrifuge.In at least one exemplary embodiment, the centrifuge may include a filler for rotating a blood component collection bladder associated with the blood component collection set, and the blood component collection bladder may be inserted into and held in a collection insert channel formed in the filler.

[0012] In at least one exemplary embodiment, the present disclosure provides an apheresis system including: a first tube having a lumen, fluidly associated with a needle, for moving whole blood from a donor through the lumen; a draw pump engaged with the first tube for drawing the whole blood from the donor into a centrifuge, the centrifuge rotating to exert centrifugal force on the whole blood to separate the whole blood into at least a first blood component and a third blood component; a blood component collection bladder inserted into the centrifuge, fluidly associated with the first tube, for separating the first blood component from the whole blood; and a blood component collection bladder fluidly associated with the blood component collection bladder and configured to separate the first blood component from the whole blood. a second tube for transferring the first blood component from the blood component collection bladder, a collection container fluidly associated with the second tube for extracting the first blood component from the apheresis system, a sensor positioned in physical proximity to the second tube for detecting that a second blood component is being extracted from the whole blood, and a return pump engaged with the second tube for returning the separated first blood component to the blood component collection bladder through the second tube and transferring at least the third blood component from the blood component collection bladder back to the donor after the second blood component is detected by the sensor while the centrifuge continues to rotate. In at least one exemplary embodiment, the first blood component may include plasma, and the second blood component may include platelets, red blood cells, and / or high hematocrit blood. In at least one exemplary embodiment, the apheresis system may further include an anticoagulant pump configured to draw anticoagulant from an anticoagulant bag and mix the anticoagulant with the whole blood at a manifold or junction fluidly associated with the first tubing. In at least one exemplary embodiment, the centrifuge may include a filler that rotates the blood component collection bladder. In at least one exemplary embodiment, the blood component collection bladder may be inserted into and held in a collection insert channel formed in the filler.

[0013] In at least one exemplary embodiment, the present disclosure provides a blood component collection set associated with an apheresis system, the blood component collection set including: a needle inserted into a donor's blood vessel to draw whole blood from the donor; a first tube having a lumen fluidly associated with the needle and moving the whole blood through the lumen, wherein a draw pump engaged with the first tube draws the whole blood from the donor; a blood component collection bladder inserted into a centrifuge and fluidly associated with the first tube to separate a first blood component and a third component from the whole blood; and a second blood component collection bladder fluidly associated with the blood component collection bladder to move the first blood component from the blood component collection bladder. and a collection container fluidly associated with the second tube for extracting the first blood component from the apheresis system. A sensor is located physically proximate to the second tube and detects that a second blood component is being extracted from the whole blood. After the second blood component is detected by the sensor, a return pump engaged with the second tube returns the separated first blood component through the second tube to the blood component collection bladder and moves at least the third blood component from the blood component collection bladder back to the donor while the centrifuge continues to rotate. In at least one exemplary embodiment, the first blood component may include plasma and the second blood component may include platelets. In at least one exemplary embodiment, the draw pump may be disengaged when the return pump returns the separated first blood component through the second tube to the blood component collection bladder and moves at least the third blood component from the blood component collection bladder back to the donor. In at least one exemplary embodiment, the blood component collection bladder may be inserted and held within a filler that rotates the blood component collection bladder in the centrifuge, and in at least one exemplary embodiment, the blood component collection bladder may be inserted and held within a collection insertion channel formed in the filler.

[0014] In at least one exemplary embodiment, the present disclosure provides a filler configured to hold a separation bladder in which components are separated from a composite fluid. The filler includes a channel for holding the separation bladder during separation of the components from the composite fluid. The channel has a first wall and a second wall opposite the first wall. A first end of the channel is adjacent to a center of the filler, and the channel spirals toward the periphery of the filler. In at least one exemplary embodiment, an apex of the channel may be narrower than a center of the channel. In at least one exemplary embodiment, at least a portion of the second wall may have a concave surface. In at least one exemplary embodiment, the second end of the channel may be positioned to experience a higher gravitational force than the first end during separation. In at least one exemplary embodiment, the apex of the channel may provide reinforcement for the separation bladder during separation.

[0015] In at least one exemplary embodiment, the present disclosure provides a fluid isolation filler comprising: a body having an axis of rotation disposed approximately at the center of mass of the body; and a fluid collection insertion channel disposed within the body and following a generally helical path extending spirally outward from a first point near the axis of rotation to a second point disposed near the outer periphery of the body. The fluid collection insertion channel curves outward toward the outer periphery of the body near an end of the generally helical path that defines a third point of the fluid collection insertion channel disposed furthest from the axis of rotation. In at least one exemplary embodiment, the fluid isolation filler may further comprise a fluid collection chamber disposed within the body and following a portion of the generally helical path, the fluid collection insertion channel connecting to the fluid collection chamber and defining an access area between the interior of the fluid collection chamber and the exterior of the body. In at least one exemplary embodiment, the fluid collection chamber may be configured to receive a disposable fluid collection bladder. In at least one exemplary embodiment, a dimension from the axis of rotation to the third point on the generally spiral path may be greater than a dimension from the axis of rotation to the second point on the generally spiral path. In at least one exemplary embodiment, a width of the fluid collection chamber at a point along the generally spiral path may be greater than a width of the fluid collection insertion channel at the point along the generally spiral path. In at least one exemplary embodiment, the fluid collection chamber may further include a first wall that follows an innermost portion of the generally spiral path and a second wall that is generally parallel to the first wall and follows an outermost portion of the generally spiral path. In at least one exemplary embodiment, the fluid collection chamber may further include one or more tapered walls disposed between the first wall and the second wall, the one or more tapered walls configured to guide the disposable fluid collection bladder into a seated position within the fluid collection chamber.In at least one exemplary embodiment, a fluid inlet for the disposable fluid collection bladder when installed in the fluid collection chamber is located adjacent the axis of rotation, and a first fluid path of the disposable fluid collection bladder follows the generally spiral path outwardly toward an end of the disposable fluid collection bladder located adjacent the third point of the fluid collection insertion channel located furthest from the axis of rotation and fluidly interconnects with a second fluid path separated from the first fluid path of the disposable fluid collection bladder and extending inwardly from the third point following the generally spiral path to a fluid outlet for the disposable fluid collection bladder located adjacent the axis of rotation. In at least one exemplary embodiment, the fluid inlet and the fluid outlet may be part of a connector attached to the disposable fluid collection bladder, and the body of the fluid separation filler may include a connection point that engages with the connector. In at least one exemplary embodiment, the connector may include at least one key feature, and the connection point may include at least one mating key feature, which may positively position the connector relative to the connection point.

[0016] In at least one exemplary embodiment, the present disclosure provides a centrifuge assembly comprising: a centrifuge housing having an internal cavity, the centrifuge housing rotating about a rotational axis of the centrifuge assembly; and a fluid separation body disposed at least partially within the internal cavity of the centrifuge housing and configured to rotate relative to the centrifuge housing about the rotational axis. The fluid separation body has a fluid collection insert channel disposed within the fluid separation body and following a generally helical path extending spirally outward from a first point adjacent the rotational axis to a second point disposed adjacent an outer periphery of the fluid separation body. In at least one exemplary embodiment, the fluid separation body further comprises a fluid collection chamber disposed within the body and following a portion of the generally helical path, the fluid collection insert channel connecting to the fluid collection chamber to define an access region between an interior of the fluid collection chamber and an exterior of the fluid separation body. In at least one exemplary embodiment, the centrifuge assembly may further include a disposable fluid collection bladder disposed within the fluid collection chamber according to the generally spiral path. The disposable fluid collection bladder may have a fluid inlet disposed adjacent the axis of rotation, and a first fluid path of the disposable fluid collection bladder may follow the generally spiral path outwardly toward an end of the disposable fluid collection bladder disposed adjacent the third point of the fluid collection insertion channel disposed furthest from the axis of rotation and fluidly interconnect with a second fluid path separated from the first fluid path of the disposable fluid collection bladder and extending inwardly from the third point along the generally spiral path to a fluid outlet for the disposable fluid collection bladder disposed adjacent the axis of rotation. In at least one exemplary embodiment, the centrifuge assembly may be part of an apheresis device.In at least one exemplary embodiment, the centrifuge housing may be divided into an upper housing and a lower housing, the upper housing including an internal cavity, the upper housing being rotatable between an open state and a closed state about a pivot axis that is offset from the rotation axis and generally perpendicular to the rotation axis, and the fluid collection insertion channel of the fluid separation body may be accessible in the open state and inaccessible in the closed state.

[0017] In at least one exemplary embodiment, the present disclosure provides a blood component collection loop comprising: a flexible loop; a system fixation loop connector disposed on a first end of the flexible loop, the system fixation loop connector being connected to a fixation loop connection portion of a centrifuge to fix the first end of the flexible loop for rotation with the centrifuge; and a filler loop connector disposed on a second end of the flexible loop opposite the first end, the filler loop connector being connected to a loop connection region of a filler, a torsional force based on twisting of the flexible loop being applied to the filler via the filler loop connector, and the flexible loop being rotationally moved to be captured by a loop rotation position guide positioned on the centrifuge. In at least one exemplary embodiment, the blood component collection loop may be part of a blood component collection set, and the blood component collection set may be associated with an apheresis system. In at least one exemplary embodiment, the loop rotation positioning guide may be attached to a rotor that rotates the loop rotation positioning guide and the flexible loop about an axis of rotation. In at least one exemplary embodiment, the blood component collection loop may be at least partially positioned by a loop positioning stop plate. In at least one exemplary embodiment, the flexible loop may be curved around the centrifuge. In at least one exemplary embodiment, the flexible loop may also be held in place by a loop storage bracket. In at least one exemplary embodiment, at least a portion of the loop rotation position guide may include a loop torsion support bearing. In at least one exemplary embodiment, the loop torsion support bearing may include a pair of roller bearings. In at least one exemplary embodiment, the loop torsion support bearing may allow the flexible loop to twist.In at least one exemplary embodiment, the twisting may cause the filler to rotate at a greater angular velocity than the centrifuge. In at least one exemplary embodiment, the flexible loop may include two or more lumens for moving whole blood and / or blood components within the flexible loop.

[0018] In at least one exemplary embodiment, the present disclosure provides an assembly for mounting a flexible loop. The assembly includes a loop rotation positioning guide having a channel for holding a flexible loop of a blood component collection set, a loop torsion support bearing disposed within a portion of the loop rotation positioning guide within the channel and supporting the flexible loop, and a loop capture arm. The loop capture arm is positioned adjacent to the channel and connected to the loop rotation positioning guide, guiding the flexible loop into the channel and contacting the loop torsion support bearing. In at least one exemplary embodiment, the assembly may be part of an apheresis device, and the loop rotation positioning guide may be attached to a centrifuge that rotates the loop rotation positioning guide and the flexible loop about a rotation axis. In at least one exemplary embodiment, the loop rotation positioning guide may further include a loop positioning stop plate for further positioning the flexible loop. In at least one exemplary embodiment, the assembly may further include a loop storage bracket positioned flush with the loop rotation positioning guide and positioned on the centrifuge to further capture the flexible loop.

[0019] In at least one exemplary embodiment, the present disclosure provides a method for automatically attaching a flexible loop to an assembly. The method includes connecting a system locking loop connector disposed on a first end of the flexible loop to a locking loop connection portion of a centrifuge to lock the first end of the flexible loop so that the flexible loop rotates together with the centrifuge; connecting a filler loop connector disposed on a second end of the flexible loop opposite the first end to a loop connection region of a filler, wherein a torsional force based on twisting of the flexible loop is applied to the filler via the filler loop connector; and rotating the flexible loop to a loop rotation positioning guide located on the centrifuge. In at least one exemplary embodiment, the flexible loop may engage a loop torsion support bearing disposed in a channel formed by the loop rotation positioning guide, the loop torsion support bearing supporting the flexible loop. In at least one exemplary embodiment, a loop capture arm may contact the flexible loop as the flexible loop is guided into the channel and rotated into contact with the loop torsion support bearing. In at least one exemplary embodiment, the loop rotation positioning guide may further include a loop positioning stop plate to prevent the flexible loop from over-rotating beyond the channel. In at least one exemplary embodiment, a loop storage bracket positioned flush with the loop rotation positioning guide and disposed on the centrifuge may further capture and hold the flexible loop.

[0020] In at least one exemplary embodiment, the present disclosure provides a soft cassette comprising: a first cassette port, a second cassette port, a direct flow lumen fluidly connected to the first cassette port and the second cassette port, a drip chamber interposed within the direct flow lumen such that fluid passing through the direct flow lumen passes through the drip chamber, and a fluid flow bypass path fluidly connected to the direct flow lumen adjacent to the first cassette port between the first cassette port and the drip chamber, and fluidly connected to the direct flow lumen adjacent to the second cassette port between the second cassette port and the drip chamber, such that fluid flowing through the fluid flow bypass path bypasses the drip chamber. In at least one exemplary embodiment, the fluid flow bypass pathway may include a first bypass branch fluidly connected to the direct flow lumen adjacent to the first cassette port and a second bypass branch fluidly connected to the direct flow lumen adjacent to the second cassette port. In at least one exemplary embodiment, the fluid flow bypass pathway may further include a fluid pressure ring disposed between and fluidly connected to the first bypass branch and the second bypass branch. In at least one exemplary embodiment, the direct flow lumen may include a first flexible region disposed between a first connection with the first bypass branch and the drip chamber, the first flexible region enabling a first fluid control valve to occlude the direct flow lumen. In at least one exemplary embodiment, the direct flow lumen may have a second flexible region disposed between a second connection with the second bypass branch and the drip chamber, the second flexible region enabling a second fluid control valve to occlude the direct flow lumen. In at least one exemplary embodiment, the direct flow lumen includes a third flexible region disposed within the first bypass branch, the third flexible region enabling a retract fluid control valve to occlude the first bypass branch.In at least one exemplary embodiment, the first cassette port may be fluidly connected to a cassette inlet tube that transfers fluid from the donor to the soft cassette or transfers fluid from the soft cassette to the donor, and the second cassette port may be fluidly connected to a loop inlet tube that transfers fluid from the soft cassette to a centrifuge or transfers fluid from the centrifuge to the soft cassette. In at least one exemplary embodiment, when fluid is drawn from the donor, the fluid may pass through the fluid flow bypass pathway. In at least one exemplary embodiment, when fluid is delivered to the donor, the fluid may pass through the direct flow lumen. In at least one exemplary embodiment, when fluid is drawn from the donor in a subsequent draw, a portion of the fluid previously delivered to the donor through the direct flow lumen may be retained in the drip chamber as the fluid passes through the fluid flow bypass pathway. In at least one exemplary embodiment, the soft cassette may be part of a blood component collection set. In at least one exemplary embodiment, the blood component collection set may be part of an apheresis system.

[0021] In at least one exemplary embodiment, the present disclosure provides a blood component collection set. the blood component collection set includes a centrifuge for separating blood components from whole blood; a cassette inlet tube fluidly connected to a donor; a loop inlet tube fluidly connected to the centrifuge; and a soft cassette, the soft cassette having a first cassette port fluidly connected to the cassette inlet tube, a second cassette port fluidly connected to the loop inlet tube, a direct flow lumen fluidly connected to the first cassette port and the second cassette port, a drip chamber interposed within the direct flow lumen such that fluid passing through the direct flow lumen passes through the drip chamber, and a fluid flow bypass path fluidly connected to the direct flow lumen adjacent to the first cassette port between the first cassette port and the drip chamber, and fluidly connected to the direct flow lumen adjacent to the second cassette port between the second cassette port and the drip chamber, such that fluid flowing through the fluid flow bypass path bypasses the drip chamber. In at least one exemplary embodiment, the fluid flow bypass pathway may include a first bypass branch adjacent to the first cassette port and fluidly connected to the direct flow lumen, a second bypass branch adjacent to the second cassette port and fluidly connected to the direct flow lumen, and a fluid pressure ring disposed between and fluidly connected to the first and second bypass branches. In at least one exemplary embodiment, the direct flow lumen comprises a first flexible region disposed between a first connection with the first bypass branch and the drip chamber, the first flexible region enabling a first fluid control valve to occlude the direct flow lumen; the direct flow lumen comprises a second flexible region disposed between a second connection with the second bypass branch and the drip chamber, the second flexible region enabling a second fluid control valve to occlude the direct flow lumen; and the direct flow lumen comprises a third flexible region disposed within the first bypass branch, the third flexible region enabling a retract fluid control valve to occlude the first bypass branch.In at least one exemplary embodiment, when fluid is drawn from the donor, the first fluid control valve and the second fluid control valve may be closed to block the direct flow lumen and the draw fluid control valve may be open to allow whole blood to pass through the fluid flow bypass pathway. In at least one exemplary embodiment, when fluid is delivered to the donor, the first fluid control valve and the second fluid control valve may be open to allow fluid to pass through the direct flow lumen and the draw fluid control valve may be closed to block the fluid flow bypass pathway. In at least one exemplary embodiment, when fluid is drawn from the donor in a subsequent draw, a portion of the fluid previously delivered to the donor through the direct flow lumen may be retained in the drip chamber as the fluid passes through the fluid flow bypass pathway.

[0022] In at least one exemplary embodiment, the present disclosure provides a method for moving fluid through a soft cassette, the method comprising providing a soft cassette comprising: a first cassette port fluidly connected to a cassette inlet tube, a second cassette port fluidly connected to a loop inlet tube, a direct flow lumen fluidly connected to the first cassette port and the second cassette port, a drip chamber interposed within the direct flow lumen such that fluid passing through the direct flow lumen passes through the drip chamber, and a fluid flow bypass path fluidly connected to the direct flow lumen adjacent the first cassette port between the first cassette port and the drip chamber, and fluidly connected to the direct flow lumen adjacent the second cassette port between the second cassette port and the drip chamber, such that fluid flowing through the fluid flow bypass path bypasses the drip chamber. In at least one exemplary embodiment, the method includes, when drawing whole blood from a donor, receiving whole blood from the cassette inlet tube at a first cassette port fluidly connected to the cassette inlet tube, transferring the whole blood to the second cassette port through the fluid flow bypass pathway, and preventing the whole blood from moving through the direct flow lumen. In at least one exemplary embodiment, when returning red blood cells to the donor, the method includes, when receiving red blood cells from the loop inlet tube at a second cassette port fluidly connected to the loop inlet tube, transferring the red blood cells to the first cassette port through the direct flow lumen and the drip chamber, and preventing the red blood cells from moving through the fluid flow bypass pathway. In at least one exemplary embodiment, when drawing fluid from the donor in a subsequent draw, a portion of the previous fluid may be sent to the donor through the direct flow lumen, and may be sent when returning red blood cells to the donor.

[0023] In at least one embodiment, the present disclosure includes a method comprising detecting activation of an apheresis device, transmitting data to a server in response to detecting the activation, determining whether software on the apheresis device is up to date based on the data, receiving a response from the server in response to the data, and disabling use of the apheresis device if the response indicates that the software is not up to date.

[0024] In at least one embodiment, the data sent to the server includes one or more of a data log, a firmware version identifier, and an error log.

[0025] In at least one embodiment, the response includes a lockout signal.

[0026] In at least one embodiment, the response includes a software update.

[0027] In at least one embodiment, the software update includes a firmware update.

[0028] In at least one embodiment, the method further comprises automatically initiating installation of the software update.

[0029] In at least one embodiment, the method further comprises ending the unusable state of the apheresis device after installing the software update.

[0030] In at least one embodiment, the method further comprises manually initiating installation of the software update.

[0031] In at least one embodiment, the method further comprises displaying a message on a graphical user interface based on the response from the server.

[0032] In at least one embodiment, the graphical user interface allows a user to initiate the installation of software.

[0033] In at least one embodiment, the method further includes determining whether an unlocking requirement has been met after disabling use of the apheresis device, and enabling use of the apheresis device in response to determining that the unlocking requirement has been met.

[0034] In at least one embodiment, the unlocking requirement is associated with an update of the software.

[0035] In at least one embodiment, the software includes one or more of firmware, applications, and an operating system.

[0036] In at least one embodiment, the method further comprises manually installing the software update.

[0037] In at least one embodiment, manually installing the software update includes connecting an external device containing the software update to the apheresis device and installing the software update.

[0038] The present disclosure provides numerous advantages depending on the particular aspect, embodiment, and / or configuration. For example, in at least one exemplary embodiment, by maintaining the centrifuge rotation speed while returning unwanted blood components to the donor, the apheresis procedure time can be reduced, e.g., by about 30% or more. This increased efficiency allows for faster and more comfortable donor donations. With faster donor donation times, donor donation centers can obtain more donor donations in a typical day, increasing productivity and revenue. Furthermore, faster donor donations increase the likelihood that donors will return for another donation. Faster donor donations also allow donor donation centers to attract donors who use other donor donation centers with slower donor donation rates.

[0039] Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.

[0040] The drawings herein are for purposes of illustrating selected embodiments only, not all possible implementations, and are not intended to limit the scope of the present disclosure. [Brief explanation of the drawings]

[0041] [Figure 1] FIG. 1 is a perspective view of an operating environment of an apheresis system in accordance with at least one exemplary embodiment of the present disclosure. [Figure 2A] FIG. 2A is a perspective view of the apheresis system shown in FIG. [Figure 2B] FIG. 2B is a first detailed perspective view of a pump of an apheresis system, according to at least one exemplary embodiment of the present disclosure. [Figure 2C] FIG. 2C is a second detailed perspective view of a pump of an apheresis system, according to at least one exemplary embodiment of the present disclosure. [Figure 2D]FIG. 2D is a detailed perspective view of a fluid valve control system in accordance with at least one exemplary embodiment of the present disclosure. [Figure 3A] FIG. 3A is a detailed perspective view of a disposable soft cassette assembly in accordance with at least one embodiment of the present disclosure. [Figure 3B] FIG. 3B is a perspective view of a disposable soft cassette assembly according to at least one embodiment of the present disclosure. [Figure 3C] FIG. 3C is an elevational cross-sectional view taken along line 3C of FIG. 3B, according to at least one exemplary embodiment of the present disclosure. [Figure 3D] FIG. 3D is an elevational cross-sectional view taken along line 3D of FIG. 3B, according to at least one exemplary embodiment of the present disclosure. [Figure 4A] FIG. 4A is a perspective view of a centrifuge assembly in an apheresis system, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 4B] FIG. 4B is a front perspective view of the centrifuge assembly shown in FIG. 4A. [Figure 4C] FIG. 4C is a rear perspective view of the centrifuge assembly shown in FIG. 4A. [Figure 4D] FIG. 4D is a schematic cross-sectional view of a centrifuge assembly in a closed state, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 4E] FIG. 4E is a schematic cross-sectional view of a centrifuge assembly in a partially open state, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 4F] FIG. 4F is a schematic cross-sectional view of a centrifuge assembly in an open state, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 4G] FIG. 4G is a perspective view of a filler for a centrifuge, according to at least one exemplary embodiment of the present disclosure. [Figure 4H] FIG. 4H is a top view of a filler for a centrifuge, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 4I]FIG. 4I is a schematic top view of a generally spiral-shaped receiving channel, according to at least one exemplary embodiment of the present disclosure. [Figure 4J] FIG. 4J is an elevational cross-sectional view taken along line 4J of FIG. 4H. [Figure 4K] FIG. 4K is a detailed cross-sectional view of a portion of a channel in a filler, according to at least one exemplary embodiment of the present disclosure. [Figure 4L] 4L shows different views of the fluid collection bladder positioned within the channel in the filler of FIG. 4K. [Figure 5A] FIG. 5A is a diagram of a fluid component collection set including a fluid component collection loop, according to at least one exemplary embodiment of the present disclosure. [Figure 5B] FIG. 5B is an illustration of a fluid component collection loop including a fluid component collection bladder, according to at least one exemplary embodiment of the present disclosure. [Figure 5C] FIG. 5C is a cross-sectional view of a fluid component collection bladder according to at least one exemplary embodiment of the present disclosure. [Figure 5D] FIG. 5D is another cross-sectional view of a fluid component collection bladder, according to at least one exemplary embodiment of the present disclosure. [Figure 5E] FIG. 5E is a perspective view of a fluid component collection loop in a bent state, according to at least one exemplary embodiment of the present disclosure. [Figure 5F] FIG. 5F is a perspective view of a loaded fluid component collection loop, according to at least one exemplary embodiment of the present disclosure. [Figure 5G] FIG. 5G is a perspective view of a fluid component collection loop mounted within a filler, according to at least one exemplary embodiment of the present disclosure. [Figure 5H] FIG. 5H is a perspective view of a fluid component collection loop mounted within a filler, according to at least one exemplary embodiment of the present disclosure. [Figure 6A] FIG. 6A is a schematic cross-sectional view of a centrifuge assembly in a first loop mounted state, according to at least one exemplary embodiment of the present disclosure. [Figure 6B]FIG. 6B is a schematic cross-sectional view of a centrifuge assembly in a second loop installation state, according to at least one exemplary embodiment of the present disclosure. [Figure 6C] FIG. 6C is a schematic cross-sectional view of a centrifuge assembly in a third loop installation state, according to at least one exemplary embodiment of the present disclosure. [Figure 7A] FIG. 7A is a schematic top view of a centrifuge assembly with a loop loaded, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 7B] FIG. 7B is a schematic plan view of a centrifuge assembly in operation, according to at least one exemplary embodiment of the present disclosure. [Figure 8] FIG. 8 is a functional diagram of one embodiment of an apheresis system, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 9] FIG. 9 is a block diagram of the electrical system of an apheresis system, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 10] FIG. 10 is another block diagram of the electrical system of the apheresis system, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 11] FIG. 11 is another block diagram of the electrical system of the apheresis system, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 12A] FIG. 12A is a flowchart of a method according to at least one exemplary embodiment of the present disclosure. [Figure 12B] FIG. 12B is a diagram of an apheresis system with a scanner, according to at least one exemplary embodiment of the present disclosure. [Figure 12C] FIG. 12C is an illustration of a bottle in accordance with at least one exemplary embodiment of the present disclosure. [Figure 12D] FIG. 12D is an illustration of a graphical user interface in accordance with at least one exemplary embodiment of the present disclosure. [Figure 13A] FIG. 13A is an isometric view of a plasma collection bottle holder, according to at least one exemplary embodiment of the present disclosure. [Figure 13B] FIG. 13B is a flowchart according to at least one exemplary embodiment of the present disclosure. [Figure 14A] FIG. 14A is a perspective view of a transfer loop holder of an apheresis system, according to at least one exemplary embodiment of the present disclosure. [Figure 14B] FIG. 14B is a partial view of the travel loop holder shown in FIG. 14A. [Figure 14C] FIG. 14C is an elevational cross-sectional view taken along line 14C shown in FIG. 14B. [Figure 14D] FIG. 14D is a partial view of a traveling loop holder in an extended position, according to at least one exemplary embodiment of the present disclosure. [Figure 14E] FIG. 14E is a partial view of a travel loop holder in a retracted position, according to at least one exemplary embodiment of the present disclosure. [Figure 14F] FIG. 14F is a partial view of the transfer loop holder in a retracted position and the lid of the centrifuge assembly of the apheresis system in an open position, according to at least one exemplary embodiment of the present disclosure. [Figure 15A] FIG. 15A is a perspective view of a load cell assembly according to at least one exemplary embodiment of the present disclosure. [Figure 15B] FIG. 15B is an exploded perspective view of the load cell assembly of FIG. 15A, according to at least one exemplary embodiment of the present disclosure. [Figure 15C] 15C is a top perspective view of a mounting plate of the load cell assembly of FIG. 15A, according to at least one exemplary embodiment of the present disclosure. [Figure 15D] FIG. 15D is a bottom perspective view of the mounting plate of FIG. 15C, according to at least one exemplary embodiment of the present disclosure. [Figure 15E] FIG. 15E is a perspective view of a bracket of the load cell assembly of FIG. 15A, according to at least one exemplary embodiment of the present disclosure. [Figure 15F]FIG. 15F is a perspective view of a load cell of the load cell assembly of FIG. 15A, according to at least one exemplary embodiment of the present disclosure. [Figure 15G] FIG. 15G is a perspective view of a load interface plate of the load cell assembly of FIG. 15A, according to at least one exemplary embodiment of the present disclosure. [Figure 15H] 15H is a perspective view of an overload support bar of the load cell assembly of FIG. 15A, according to at least one exemplary embodiment of the present disclosure. [Figure 15I] FIG. 15I is a partial cross-sectional view of the load cell assembly of FIG. 15A in an engaged state, according to at least one exemplary embodiment of the present disclosure. [Figure 15J] 15J is a partial cross-sectional view of the load cell assembly of FIG. 15A in a disengaged state with a portion of the first magnet cut away, according to at least one exemplary embodiment of the present disclosure. [Figure 15K] FIG. 15K is a side view of a cradle of the load cell assembly of FIG. 15A, according to at least one exemplary embodiment of the present disclosure. [Figure 15L] FIG. 15L is a front view of the cradle of FIG. 15K, according to at least one exemplary embodiment of the present disclosure. [Figure 15M] FIG. 15M is a perspective view of a container within the cradle of FIG. 15K, according to at least one exemplary embodiment of the present disclosure. [Figure 16A] FIG. 16A is a flowchart of a method according to at least one exemplary embodiment of the present disclosure. [Figure 16B] FIG. 16B is a diagram of a network-connected apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 16C] FIG. 16C is an illustration of a graphical user interface according to at least one exemplary embodiment of the present disclosure. [Figure 16D] FIG. 16D is a block diagram of a computing system in accordance with at least one exemplary embodiment of the present disclosure. [Figure 17A]FIG. 17A is a flowchart of a method according to at least one exemplary embodiment of the present disclosure. [Figure 17B] FIG. 17B is a diagram of an apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 17C] FIG. 17C is a diagram of an output device, according to at least one exemplary embodiment of the present disclosure. [Figure 17D] FIG. 17D is a diagram of an output device, according to at least one exemplary embodiment of the present disclosure. [Figure 17E] FIG. 17E is a diagram of an output device, according to at least one exemplary embodiment of the present disclosure. [Figure 18A] FIG. 18A is a partially exploded perspective view of an apheresis system including a modular service sled member, according to at least one exemplary embodiment of the present disclosure. [Figure 18B] FIG. 18B is a schematic cross-sectional elevation view of a modular service sled member disengaged from a base of an apheresis system, according to at least one exemplary embodiment of the present disclosure. [Figure 18C] FIG. 18C is a bottom perspective view of a return pump assembly of the apheresis system of FIG. 18A, according to at least one exemplary embodiment of the present disclosure. [Figure 18D] FIG. 18D is a schematic cross-sectional elevation view of the modular service sled member of FIG. 18C in engagement with the base of an apheresis system, according to at least one exemplary embodiment of the present disclosure. [Figure 18E] FIG. 18E is a flowchart illustrating a method of maintaining an apheresis system, according to at least one exemplary embodiment of the present disclosure. [Figure 19A] FIG. 19A is a perspective view of a collection bottle in accordance with at least one exemplary embodiment of the present disclosure. [Figure 19B] FIG. 19B is an elevational view of the collection bottle of FIG. 19A positioned in a plasma collection cradle of an apheresis system, according to at least one exemplary embodiment of the present disclosure. [Figure 19C]FIG. 19C is a perspective view of the canister of the collection bottle of FIG. 19A. [Figure 19D] FIG. 19D is a top-down perspective view of the lid of the collection bottle of FIG. 19A. [Figure 19E] FIG. 19E is a bottom view of the lid of the collection bottle of FIG. 19A. [Figure 19F] FIG. 19F is a partial cross-sectional view of the collection bottle of FIG. 19A before collection (i.e., before use), according to at least one exemplary embodiment of the present disclosure. [Figure 19G] FIG. 19G is a partial view of the collection bottle of FIG. 19A after collection (ie, after use), according to at least one exemplary embodiment of the present disclosure. [Figure 19H] FIG. 19H is an elevational view of a collection bottle shipping package including an array of filled (i.e., post-collection) collection bottles, according to at least one exemplary embodiment of the present disclosure. [Figure 19I] FIG. 19I is a side view of the collection bottle of FIG. 19A positioned in a collection cradle, according to at least one exemplary embodiment of the present disclosure. [Figure 19J] FIG. 19J is a perspective view of the collection bottle of FIG. 19A positioned in a collection cradle. [Figure 20] FIG. 20 is a flowchart of a method in accordance with at least one exemplary embodiment of the present disclosure. [Figure 21A] FIG. 21A is a partial perspective view of the apheresis system of FIG. 18A, according to at least one exemplary embodiment of the present disclosure. [Figure 21B] FIG. 21B is an elevational view of a first hanger assembly of the apheresis system of FIG. 21A, according to at least one exemplary embodiment of the present disclosure. [Figure 21C] FIG. 21C is an exploded perspective view of the first hanger assembly of FIG. 21B according to at least one exemplary embodiment of the present disclosure. [Figure 21D] FIG. 21D is an elevational view of a second hanger assembly of the apheresis system of FIG. 21A, according to at least one exemplary embodiment of the present disclosure. [Figure 21E] FIG. 21E is an exploded perspective view of the second hanger assembly of FIG. 21D, according to at least one exemplary embodiment of the present disclosure. [Figure 21F] FIG. 21F is a perspective view of an air assembly of the apheresis system of FIG. 21A, according to at least one exemplary embodiment of the present disclosure. [Figure 21G] FIG. 21G is a partial perspective view of a centrifuge housing of the apheresis system of FIG. 21A, according to at least one exemplary embodiment. [Figure 21H] FIG. 21H is a perspective view of the centrifuge assembly of the apheresis system of FIG. 21A in a cover locked state, according to at least one exemplary embodiment of the present disclosure. [Figure 21I] FIG. 21I is a partially exploded perspective view of a latch engagement plate and latch assembly of the centrifuge of FIG. 21H, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 21J] FIG. 21J is a perspective view of a cover engagement plate of the centrifuge assembly of FIG. 21H, according to at least one exemplary embodiment of the present disclosure. [Figure 21K] FIG. 21K is a perspective view of a cover of the centrifuge assembly of FIG. 21H, according to at least one exemplary embodiment of the present disclosure. [Figure 21L] FIG. 21L is a perspective view of a base of the centrifuge assembly of FIG. 21H, according to at least one exemplary embodiment of the present disclosure. [Figure 21M] FIG. 21M is a partial bottom perspective view of the centrifuge assembly of FIG. 21H in a latched state, according to at least one exemplary embodiment of the present disclosure. [Figure 21N] FIG. 21N is a partial bottom perspective view of the centrifuge assembly of FIG. 21M in an unlatched state, according to at least one exemplary embodiment of the present disclosure. [Figure 21O] FIG. 21O is a perspective view of the compressor assembly of FIG. 21H in a cover unlocked state, according to at least one exemplary embodiment of the present disclosure. [Figure 22A]FIG. 22A is a flowchart of a method according to at least one exemplary embodiment of the present disclosure. [Figure 22B] FIG. 22B is a flowchart of a method according to at least one exemplary embodiment of the present disclosure. [Figure 22C] FIG. 22C illustrates a centrifuge chamber according to at least one exemplary embodiment of the present disclosure. [Figure 23A] FIG. 23A is an elevational cross-sectional view of a deflection-based tube condition sensor in accordance with at least one exemplary embodiment of the present disclosure. [Figure 23B] FIG. 23B is a perspective view of the flexure block of the flexure-based tube condition sensor of FIG. 23A. [Figure 23C] FIG. 23C is a schematic diagram illustrating exaggerated displacement of the flexure block of FIG. 23B when pressure is applied to the tube segment engaged with the flexure block. [Figure 23D] FIG. 23D is a perspective view of another example of a flexure block of a flexure-based tube condition sensor, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 24A] FIG. 24A is an elevational view of the blood component collection loop of FIG. 5A according to an embodiment of the present disclosure. [Figure 24B] FIG. 24B is an elevational view of the blood component collection loop of FIG. 24A in a first folded state according to at least one exemplary embodiment. [Figure 24C] FIG. 24C is an elevational view of the blood component collection loop of FIG. 24A in a second folded state according to at least one exemplary embodiment. [Figure 24D] FIG. 24D is an elevational view of the blood component collection loop of FIG. 24A in a third folded state according to at least one exemplary embodiment. [Figure 24E] FIG. 24E is a bottom view of a blood component collection loop with a folded and packaged bladder in accordance with at least one exemplary embodiment of the present disclosure. [Figure 24F] FIG. 24F is a perspective view of the blood component collection set of FIG. 5A according to at least one exemplary embodiment. [Figure 24G] FIG. 24G is a perspective view of the blood component collection loop of FIG. 24F without a sealing tape wrap according to at least one exemplary embodiment. [Figure 24H] FIG. 24H is a plan view of the blood component collection loop of FIG. 24A according to at least one exemplary embodiment. [Figure 24I] FIG. 24I is a perspective view of a filler of the centrifuge assembly of FIG. 4B, according to at least one exemplary embodiment of the present disclosure. [Figure 24J] FIG. 24J is a detailed schematic plan view of a portion of the collect insert channel of the centrifuge assembly of FIG. 24I, according to at least one exemplary embodiment. [Figure 25A] FIG. 25A is a perspective view of another soft cassette according to at least one exemplary embodiment of the present disclosure. [Figure 25B] FIG. 25B is a side view of the soft cassette of FIG. 25A, according to at least one exemplary embodiment of the present disclosure. [Figure 25C] FIG. 25C is a front view of the soft cassette of FIG. 25A, according to at least one exemplary embodiment of the present disclosure. [Figure 25D] FIG. 25D is a schematic cross-sectional view of a soft cassette assembly including the soft cassette of FIG. 25A, according to at least one exemplary embodiment of the present disclosure. [Figure 25E] FIG. 25E is a perspective view of the soft cassette assembly of FIG. 25D in an open state, according to at least one exemplary embodiment of the present disclosure. [Figure 25F] FIG. 25F is a partial cross-sectional view of the soft cassette of FIG. 25A in a first pressure state, according to at least one exemplary embodiment of the present disclosure. [Figure 25G] FIG. 25G is a partial cross-sectional view of the soft cassette of FIG. 25A in a second pressure state, according to at least one exemplary embodiment of the present disclosure. [Figure 25H] FIG. 25H is an exploded view of the soft cassette of FIG. 25A, according to at least one exemplary embodiment of the present disclosure. [Figure 25I]FIG. 25I is another exploded view of the soft cassette of FIG. 25A, according to at least one exemplary embodiment of the present disclosure. [Figure 25J] FIG. 25J is a flowchart illustrating a method of manufacturing the soft cassette of FIG. 25A, according to at least one exemplary embodiment of the present disclosure. [Figure 25K] FIG. 25K is a partial cross-sectional view of the soft cassette of FIG. 25A showing the valve region, according to at least one exemplary embodiment of the present disclosure. [Figure 25L] FIG. 25L is a detailed cross-sectional view of the valve region of FIG. 25K, according to at least one exemplary embodiment of the present disclosure. [Figure 25M] FIG. 25M is a schematic illustration of another soft cassette, according to at least one exemplary embodiment of the present disclosure. [Figure 26A] FIG. 26A is a perspective view of a packaged separation set in accordance with at least one exemplary embodiment of the present disclosure. [Figure 26B] FIG. 26B is an elevational view of the separation set of FIG. 26A in a packaged configuration, according to at least one exemplary embodiment of the present disclosure. [Figure 26C] FIG. 26C is a schematic illustration of a separation assembly including the separation set of FIG. 26A, according to at least one exemplary embodiment of the present disclosure. [Figure 26D] FIG. 26D is a schematic illustration of an apheresis system including a properly installed component collection assembly, according to at least one exemplary embodiment of the present disclosure. [Figure 26E] FIG. 26E is a partial perspective view of a valve housing of the apheresis system of FIG. 26D, according to at least one exemplary embodiment of the present disclosure. [Figure 26F] FIG. 26F is a schematic illustration of an apheresis system including an improperly installed component collection assembly, according to at least one exemplary embodiment of the present disclosure. [Figure 26G] FIG. 26G is a schematic illustration of an AC bag of the separation assembly of FIG. 26C, according to at least one exemplary embodiment of the present disclosure. [Figure 26H] FIG. 26H is a schematic illustration of a saline bag of the separation assembly of FIG. 26C, according to at least one exemplary embodiment of the present disclosure. [Figure 26I] FIG. 26I is a perspective view of a container in a cradle of the apheresis system of FIG. 26D, according to at least one exemplary embodiment of the present disclosure. [Figure 26J] FIG. 26J is a side view of the container and cradle of FIG. 26I, according to at least one exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0042] Corresponding reference characters indicate corresponding parts shown in the several views of the drawings.

[0043] Exemplary embodiments are more fully described with reference to the accompanying drawings.

[0044] The exemplary embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope to those skilled in the art. Numerous specific details are set forth, such as examples of specific components, devices, and methods, to provide a thorough understanding of the embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details are not necessary, that the exemplary embodiments may be embodied in many different forms, and that none of these should be construed as limiting the scope of the present disclosure. In some exemplary embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.

[0045] The terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly dictates otherwise. The terms "comprises," "comprising," "including," and "having" are inclusive and thus specify the presence of stated features, entities, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. The method steps, processes, and operations described herein should not be construed as necessarily requiring performance in the particular order described or illustrated, unless specifically identified as such. It should also be understood that additional or alternative steps may be employed.

[0046] When an element or layer is referred to as "on," "engaged to," "connected to," or "coupled to" another element or layer, it may be directly on, directly engaged with, directly connected to, or directly coupled to the other element or layer, or intervening elements or layers may be present. Conversely, when an element is referred to as "directly on," "directly engaged with," "directly connected to," or "directly coupled to" another element or layer, there are no intervening elements or layers present. Other terms used to describe relationships between elements should be interpreted similarly (e.g., "between" vs. "directly between," "adjacent" vs. "directly adjacent," etc.). As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0047] Terms such as "first," "second," and "third" may be used herein to describe various elements, components, regions, layers, and / or sections, but these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are used only to distinguish one element, component, region, layer, or section from another region, layer, or section. Terms such as "first," "second," and other numerical terms, when used herein, do not imply a sequence or order unless clearly indicated by context. Thus, a first element, first component, first region, first layer, or first section described below could also be referred to as a second element, second component, second region, second layer, or second section without departing from the teachings of the exemplary embodiments.

[0048] Spatial terms such as "inside," "outside," "beneath," "below," "lower," "upper," and "above" are used herein for ease of description when describing the relationship of one element or feature to another element(s) or feature(s), as shown in the figures. Spatial terms may be intended to encompass different orientations of the device during use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures were inverted, elements described as being "beneath" or "beneath" other elements or features would change accordingly to be "above" them. Thus, for example, the term "below" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other angles), and the spatial descriptions used herein should be interpreted accordingly.

[0049] Various components are referred to herein as "operably associated." As used herein, "operably associated" refers to components that are linked together in an operable manner and includes embodiments in which components are directly coupled as well as embodiments in which other components are disposed between the coupled components. "Operably associated" components can be "fluidically associated." "Fluidly associated" refers to components that are linked together so that fluid can be transported between them. "Fluidly associated" includes embodiments in which other components are disposed between two fluidly associated components as well as components that are directly connected. Fluidly associated components can include components that do not contact the fluid but contact other components to operate the system (e.g., a peristaltic pump that pumps fluid through flexible tubing by squeezing the outside of the tubing).

[0050] As used herein, the term "donor" can refer to anyone who provides a fluid, such as whole blood, to an apheresis system. A donor can also be a patient who temporarily provides a fluid to an apheresis system, where the fluid is processed, treated, manipulated, etc., before being returned to the patient.

[0051] As used herein, the term "automatic" and variations thereof refer to any process or operation that occurs without substantial human input when the process or operation is performed. However, a process or operation may be automatic if significant or insignificant human input is used in the execution of the process or operation, but the input is received before the process or operation is performed. Human input is considered significant if it affects how the process or operation is performed. Human input that implies consent to the execution of a process or operation is not considered "critical."

[0052] As used herein, the term "computer-readable medium" refers to any tangible storage and / or transmission medium that participates in providing instructions to a processor for execution. Such media may take many forms, including, but not limited to, nonvolatile media, volatile media, and transmission media. Nonvolatile media include, for example, NVRAM or magnetic or optical disks. Volatile media include dynamic memory such as main memory. Common forms of computer-readable media include, for example, floppy disks, flexible disks, hard disks, magnetic tape, or any other magnetic media, magneto-optical media, CD-ROMs, any other optical media, punch cards, paper tape, any other physical media with patterns of holes, RAM, PROMs, EPROMs, FLASH-EPROMs, solid-state media such as memory cards, any other memory chips or cartridges, carrier waves, or any other medium from which a computer can read. A digital file attachment to an email or other self-contained information archive or set of archives is considered a distribution medium equivalent to a tangible storage medium. When the computer-readable medium is configured as a database, it should be understood that the database may be any type of database, such as relational, hierarchical, object-oriented, and / or the like. Accordingly, the present disclosure is considered to encompass tangible storage or distribution media on which software implementations of the present disclosure are stored, and prior art-recognized equivalents and successor media.

[0053] As used herein, the term "module" refers to any known or later developed hardware, software, firmware, artificial intelligence, fuzzy logic, or combination of hardware and software that is capable of performing the functionality associated with that element.

[0054] As used herein, the terms "determining," "calculating," and "computing," as well as variations thereof, are used interchangeably and include any type of methodology, process, mathematical operation, or technique.

[0055] Embodiments of the present disclosure will now be more fully described in connection with apheresis methods and systems with reference to the accompanying drawings. The following embodiments will be described with reference to separating blood components from whole blood. However, this is provided for illustrative purposes only. It should be noted that the embodiments are not limited to the following description. The embodiments are intended for use in products, processes, devices, and systems for separating any complex fluid. Thus, the present disclosure is not limited to separating blood components from whole blood.

[0056] FIG. 1 illustrates a perspective view of an operating environment 100 of an apheresis system 200 according to at least one exemplary embodiment of the present disclosure. The operating environment 100 includes an apheresis system 200, a donor 102, and one or more connections (e.g., donor supply tubing 104, cassette inlet tubing 108A, anticoagulant tubing 110, etc.) extending from the donor 102 to the apheresis system 200 and / or vice versa. As shown in FIG. 1 , the donor supply tubing 104 is fluidly connected to at least one blood vessel, e.g., a vein, of the donor 102 via venipuncture. For example, a cannula connected to the end of the donor supply tubing 104 is inserted through the skin of the donor 102 and into a target site, i.e., a vein. This connection provides a venous pathway for blood to flow from the donor 102 to the apheresis system 200 and / or for blood components to flow back to the donor 102. In at least one exemplary embodiment, the fluid pathways and connections may form an extracorporeal tubing circuit of the apheresis system 200.

[0057] Blood supplied from the donor 102 flows along donor supply tubing 104, through tubing connector 106, and along cassette inlet tubing 108A into soft cassette assembly 300. Soft cassette assembly 300 may include one or more fluid control paths and valves for selectively controlling the flow of blood to and / or from donor 102. Apheresis system 200 may include an anticoagulant supply contained in anticoagulant (AC) bag 114. Anticoagulant is pumped through at least anticoagulant tubing 110 and tubing connector 106 to prevent clotting of blood within apheresis system 200.

[0058] The anticoagulant may include, but is not limited to, one or more of citrate and / or unfractionated heparin. The AC bag 114 and other bags or bottles described herein may be formed from, for example, but not limited to, one or more of polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone, thermoplastic, thermoplastic elastomer, polymer, copolymer, and / or combinations thereof. The amount of AC in the AC bag 114 may vary based on various factors, including the mass of the donor 102, the volumetric flow rate of blood from the donor, etc. In one example, the volume in the AC bag 114 is 250-500 mL, although the volume in the AC bag 114 may be greater or less than this volume.

[0059] In at least one exemplary embodiment, the apheresis system 200 may include a plasma collection bottle 122 or container, saline fluid contained in a saline bag 118, and one or more lines or tubing (e.g., fluid transfer tubing, etc.) (such as saline tubing 116 and plasma tubing 120) connecting the saline bag 118 and the plasma collection bottle 122 with the extracorporeal tubing circuit of the apheresis system 200. The amount of saline provided in the saline bag 118 is between 500 and 800 mL, although the volume within the saline bag 118 may be greater or less than this volume. An example volume for a blood component, e.g., plasma, may be 880 mL. Thus, the plasma collection bottle 122 can hold at least this amount of plasma. In at least one exemplary embodiment, the plasma collection bottle 122 may include a connection point located at, adjacent to, or in physical proximity to the approximate bottom-most portion of the plasma collection bottle 122 (e.g., when the plasma collection bottle 122 is placed in the plasma collection cradle 232C, as shown in FIG. 2A ). The connection point may include one or more connectors configured to interconnect with the plasma tubing 120 to receive and / or transport plasma. Locating the connection point at the bottom of the plasma collection bottle 122 allows plasma contained within the plasma collection bottle 122 to travel back out of the plasma tubing 120 through a line, as described herein, without trapping air bubbles, etc. In at least one exemplary embodiment, the plasma collection bottle 122 may be configured as a flexible bag, a rigid container, and / or other container, and thus, the plasma collection bottle 122 is not limited to a bottle or bottle-like container.

[0060] FIG. 2A shows a perspective view of the apheresis system 200 depicted in FIG. 1 . The apheresis system 200 enables a continuous whole blood separation process. In at least one exemplary embodiment, whole blood is drawn from a donor 102 and substantially continuously fed to a blood component separation device of the apheresis system 200. In the blood component separation device, the blood is separated into various components, and at least one of these blood components is collected from the apheresis system 200. In at least one exemplary embodiment, one or more of the separated blood components may be collected for subsequent use or returned to the donor 102. Blood is drawn from the donor 102 and directed to a centrifuge of the apheresis system 200 through an opening 220 in an access panel 224 of the apheresis system 200. In at least one exemplary embodiment, the tubing used in the extracorporeal tubing circuit, donor supply tubing 104, cassette inlet tubing 108A, inlet tubing 108B (also referred to as loop inlet tubing 108B), outlet tubing 112 (also referred to as loop outlet tubing 112), saline tubing 116, and plasma tubing 120, collectively comprise a closed, sterile, disposable system or blood component collection set, described further below.

[0061] Examples of apheresis systems, plasmapheresis systems, and other separation systems that may be used with embodiments of the present disclosure (such as apheresis system 200) include, but are not limited to, the SPECTRA OPTIA® apheresis system, the COBE® Spectra apheresis system, and the TRIMA ACCEL® automated blood collection system (these systems are manufactured by Terumo BCT, located in Lakewood, Colorado).

[0062] The operation of the various pumps, valves, and blood component separation device or centrifuge may be controlled by one or more processors included in apheresis system 200, and is preferably controlled by multiple embedded computer processors that are part of a computer system. The computer system may include components that allow a user to interface with the computer system, including, for example, memory and storage (RAM, ROM (e.g., CD-ROM, DVD), magnetic drives, optical drives, flash memory, etc.), communication / networking devices (e.g., wired, such as a modem / network card, or wireless, such as WiFi), input devices such as a keyboard, touchscreen, camera, and / or microphone, and output devices such as a display and audio system. To assist the operator of apheresis system 200 with various aspects of its operation, in at least one exemplary embodiment, the blood component separation device or centrifuge may include a graphical user interface with a display that includes an interactive touchscreen.

[0063] The apheresis system 200 may include a housing 204 and / or structural frame, a cover 210, an access panel 224 disposed on the front portion 202 and / or rear portion 206 of the apheresis system 200, and one or more supports 232A-232C. The supports may include hooks, rests, cradles, arms, protrusions, plates, and / or other support features for holding, resting, and / or supporting the container or AC bag 114, the saline bag 118, and the plasma collection bottle 122. In at least one exemplary embodiment, the features of the apheresis system 200 are described in relation to the coordinate system 103 and / or one or more axes thereof. The housing 204 may include an apparatus frame (e.g., formed from welded, bolted, and / or connected structural elements, extrusions, beams, etc.) to which one or more panels, such as the cover 210, doors, subassemblies, and / or components, are attached. In at least one exemplary embodiment, at least one panel of the apheresis system 200 may include a mounting surface for the soft cassette assembly 300, one or more pumps, such as the draw pump 208, the return pump 212, the anticoagulant (AC) pump 216, and / or a fluid valve control system 228 (e.g., plasma and saline valve control, etc.).

[0064] Access panel 224 may include one or more handles, locks, and pivots or hinges 226 (e.g., door hinges, piano hinges, continuous hinges, clean room hinges, etc.). In any event, access panel 224 is selectively opened to provide access to the interior of apheresis system 200, and more specifically, the blood separation assembly or centrifuge. In at least one exemplary embodiment, access panel 224 provides access to the interior for installing and / or removing one or more components of a blood component collection set from the centrifuge. Details of the centrifuge are described in more detail below with respect to at least FIGS. 4A-4L.

[0065] The interior of apheresis system 200 may be divided into at least a centrifuge section and a control section. For example, the centrifuge section includes a cavity configured to receive a centrifuge, a spinning motor, and associated hardware. This area may be physically separated from the control section by one or more walls of the cavity. In at least one exemplary embodiment, access to the control section (e.g., configured to house or include a motor controller, a CPU or processor, electronics, wiring, etc.) may be provided through a rigidly fastened panel of housing 204 and / or a panel separate from access panel 224.

[0066] In at least one exemplary embodiment, apheresis system 200 includes multiple pumps, such as draw pump 208, return pump 212, or AC pump 216, configured to control the flow of fluids (e.g., blood and / or blood components, anticoagulant, saline, etc.) through apheresis system 200. For example, apheresis system 200 includes draw pump 208, which controls blood flow to and / or from donor 102 to a centrifuge of apheresis system 200. Drawing pump 208 may engage a portion of inlet tubing 108B disposed between soft cassette assembly 300 and the centrifuge of apheresis system 200. In at least one exemplary embodiment, apheresis system 200 may include return pump 212, which is configured to control the flow of separated blood components (e.g., plasma) from the centrifuge to plasma collection bottle 122 and / or vice versa. Additionally or alternatively, return pump 212 may control the flow of saline (e.g., provided from saline bag 118) throughout the blood component collection set and / or apheresis system 200. AC pump 216 may engage a portion of anticoagulant tubing 110 to selectively control the flow of anticoagulant throughout the blood component collection set of apheresis system 200. As shown in FIG. 2A , draw pump 208, return pump 212, and AC pump 216 may be at least partially disposed on top of cover 210 of apheresis system 200.

[0067] 2B and 2C show various perspective views of the draw pump 208, the return pump 212, or the AC pump 216 of the apheresis system 200, according to at least one exemplary embodiment of the present disclosure. While the draw pump 208 is shown and described with reference to FIGS. 2B and 2C, it should be understood that the other pump assemblies of the apheresis system 200, i.e., the return pump 212 and the AC pump 216, may differ in some details and operate differently. However, in many cases, the return pump 212 and / or the AC pump 216 may be substantially similar in construction or include similar structural parts, if not identical, to the described draw pump 208.

[0068] The draw pump 208 may include a pump cover 236 or housing configured to at least partially house the moving elements of the draw pump 208. In at least one exemplary embodiment, the pump cover 236 may include a hinged tube guard door subassembly or tube guard 240 configured to open and close about a tube guard pivot axis 242. In at least one exemplary embodiment, the tube guard 240 may be attached to the pump cover 236 via one or more fasteners disposed along the tube guard pivot axis 242. As shown in FIGS. 2B and 2C , blood supplied by the donor 102 may be conveyed or drawn into the centrifuge by the draw pump 208 in a first draw direction, i.e., a centrifuge direction 250A. Additionally or alternatively, blood or other fluids may be conveyed or drawn into the donor 102 by the draw pump 208 in a donor direction 250B opposite the centrifuge direction 250A.

[0069] In at least one exemplary embodiment, the draw pump 208 and / or the return pump 212, AC pump 216 may be a tube pump, peristaltic pump, diaphragm pump, and / or other pump configured to manipulate the flow of fluid (e.g., blood, blood components, anticoagulant, saline, etc.) within at least a portion of a tube. For example, the draw pump 208, the return pump 212, or the AC pump 216 may include a motor operatively interconnected with a rotating tube contact assembly. In operation, a tube (e.g., the inlet tube 108B, the outlet tube 112, the anticoagulant tube 110, etc.) is inserted into the lead tube guide 244, the tube pressurizing block 248, and the end tube guide 252 adjacent the rotating tube contact head. In at least one exemplary embodiment, the tube pressurizing block 248 may be moved away from the rotating tube contact head of the draw pump 208, the return pump 212, or the AC pump 216 to provide a mounting clearance area, or vice versa. The rotary tube contact head includes a plurality of rotary pressure rollers 268, each configured to rotate about a respective pressure roller axis of rotation 264. Each of the rotary pressure rollers 268 is disposed between a first rotary pump plate 272A and a second rotary pump plate 272B, where the first rotary pump plate 272A and the second rotary pump plate 272B are configured to rotate about the pump axis of rotation 260. In at least one exemplary embodiment, the rotary pressure rollers 268 may be disposed at the periphery of the first rotary pump plate 272A and the second rotary pump plate 272B.

[0070] One or more of the draw pump 208, return pump 212, and AC pump 216 may include or operate similarly to, without limitation, a Pulsafeeder® Model UX-74130 peristaltic pump, a Pulsafeeder® MEC-O-MATIC series pump, all manufactured by Pulsafeeder Inc. of Punta Gorda, Florida. Other examples of the draw pump 208, return pump 212, and AC pump 216 include, but are not limited to, an INTEGRA DOSE IT laboratory peristaltic pump manufactured by INTEGRA Biosciences AG of Switzerland, and a WELCO WP1200, WP1100, WP1000, WPX1, and / or WPM series peristaltic pump, all manufactured by WELCO Co., Ltd. of Tokyo, Japan.

[0071] When the tube is loaded into the lead tube guide 244, the tube pressurizing block 248, and / or the end tube guide 252, at least a portion of the rotating pressure roller 268 engages with, contacts, or presses against the tube disposed between the rotating tube contact head and the tube pressurizing block 248. When the first rotating plate 272A and the second rotating plate 272B rotate about the pump rotation axis 260, the rotating pressure roller 268 presses against the tube portion between the draw pump 208, the return pump 212, or the AC pump 216 and the tube pressurizing block 248, and as the rotating pressure roller 268 moves, the fluid inside the tube portion can be reliably moved in a specific direction, such as the centrifuge direction 250A or the donor direction 250B. For example, when the first rotary pump plate 272A and the second rotary pump plate 272B rotate counterclockwise about the pump rotation axis 260, the rotation of the rotary pressure roller 268 pressing against the tube between the rotary pressure roller 268 and the tube pressure block 248 can move or pump fluid in the centrifuge direction 250A. As another example, when the first rotary pump plate 272A and the second rotary pump plate 272B rotate clockwise about the pump rotation axis 260, the rotation of the rotary pressure roller 268 pressing against the tube between the rotary pressure roller 268 and the tube pressure block 248 can move or pump fluid in the donor direction 250B. When not actively pumping, the pump 208 is maintained in a state where at least one rotary pressure roller 268 continues to occlude the inlet tube 108B (normally closed, or NC) or in a state where the rotary pressure roller 268 does not occlude the inlet tube 108B (normally open, or NO). Thus, the draw pump 208 can also act as a "valve" to prevent or allow fluid movement based on its state when it is not operating. This capability is also possible with the return pump 212 and / or AC 216.

[0072] The tube guard 240 and pump cover 236 serve to protect the operator (e.g., phlebotomist, apheresis technician, etc.) and / or donor 102 from accidental contact with one or more moving parts of the retract pump 208, return pump 212, and AC pump 216. In at least one exemplary embodiment, the tube guard 240 is held in a closed position via one or more guard closure features 254 disposed on or operatively associated with the tube guard 240, lead tube guide 244, tubing pressurizing block 248, and / or end tube guide 252. These guard closure features 254 may be magnets housed in the tube guard 240, lead tube guide 244, tubing pressurizing block 248, and / or end tube guide 252. In at least one exemplary embodiment, the retract pump 208, return pump 212, and AC pump 216 may be stopped or prevented from moving / operating when the tube guard 240 is open. In at least one exemplary embodiment, a door closure sensor may be included in the guard closure feature 254 , the lead tube guide 244 , the end tube guide 252 , and / or the tube pressurizing block 248 .

[0073] One or more fluid control valves can be used to control the routing or flow direction of fluids delivered through the tubing of apheresis system 200. In at least one exemplary embodiment, apheresis system 200 includes a plasma and saline valve control system, such as fluid valve control system 228, positioned adjacent saline bag 118 and / or plasma collection bottle 122. Fluid valve control system 228 is shown in a detailed perspective view in FIG. 2D.

[0074] As shown in FIG. 2D , the outlet tubing 112 passes through the return pump 212 and is interconnected with a saline-plasma tubing y-connector 280. The saline-plasma tubing y-connector 280 connects the outlet tubing 112 to the saline tubing 116 and plasma tubing 120 lines. The fluid valve control system 228 may include an air detection sensor 284 disposed at a first end of the saline-plasma valve housing 276 and surrounding a portion of the outlet tubing 112. The air detection sensor 284 may be any optical, ultrasonic, or other type of sensor capable of detecting the presence of fluid or air in the outlet tubing 112 and providing a signal to the controller of the apheresis system 200. The type of air detection sensor 284 may include, for example, a SONOCHECK ABD05 sensor manufactured by SONOTEC US Inc., or other similar sensors.

[0075] Saline-plasma valve housing 276 includes a plurality of receiving features (e.g., grooves, channels, receptacles, etc.) that receive outlet tubing 112, saline tubing 116, a portion of plasma tubing 120, and / or saline-plasma tubing y-connector 280. Upon detecting air in outlet tubing 112, fluid valve control system 228 selectively activates one or more of the fluid control valves, such as plasma flow control valve 286, saline flow control valve 288. In at least one exemplary embodiment, detection of air via air detection sensor 284 signals and / or triggers an operational step in a control method as described herein.

[0076] The plasma flow control valve 286 and / or the saline flow control valve 288 may be solenoid valves, linear actuators, pinch valves, clamp valves, tubing valves, and / or other actuatable valves configured to selectively alter (e.g., occlude) a fluid passageway associated with a particular portion of the outlet tubing 112, the saline tubing 116, or the plasma tubing 120. As shown in FIG. 2D , the plasma flow control valve 286 may be configured to pinch a portion of the plasma tubing 120 that is at least partially contained within a receiving functional portion of the saline-plasma valve housing 276. The saline flow control valve 288 may be configured to pinch a portion of the saline tubing 116 that is at least partially contained within a receiving functional portion of the saline-plasma valve housing 276. In either case, the plasma flow control valve 286 and the saline flow control valve 288 include extendable fingers that are actuatable to move from a retracted or partially retracted position to an extended or partially extended position to pinch the tubing portion contained within the saline-plasma valve housing 276. It should be understood that while the plasma flow control valve 286 and the saline flow control valve 288 may completely pinch the tubing (e.g., completely restrict fluid flow through the tubing), the plasma flow control valve 286 and the saline flow control valve 288 may also be partially actuated to a position that partially restricts fluid flow in a portion of the tubing.

[0077] It will be appreciated that the draw pump 208, return pump 212, and AC pump 216 include other components as described in U.S. Patent Application No. 18 / 116,527, entitled "Fluid Control and Bypass Functions for an Apheresis System," filed March 2, 2023, and having attorney docket number 18955-000029-US, the entirety of which is expressly incorporated herein by reference.

[0078] First example of a soft cassette with integrated functional parts FIG. 3A is a partial perspective view of a soft cassette assembly according to at least one exemplary embodiment.

[0079] 3A, a detailed perspective view of a disposable soft cassette assembly 300 according to an embodiment of the present disclosure is shown. The soft cassette assembly 300 includes a base plate 302 and a cassette access door 304 attached to the base plate 302 via at least one hinge 306 and / or a cassette access door latch 308. In at least one exemplary embodiment, the cassette access door 304 is unlocked by actuating the cassette access door latch 308 to pivot the cassette access door 304 about a cassette access door hinge axis 310.

[0080] In at least one exemplary embodiment, the soft cassette assembly 300 may be configured with one or more soft cassette receiving features 312 for at least partially accommodating and / or positioning the soft cassette 314 therein. The soft cassette 314 may be part of a blood component collection set described herein. For example, the soft cassette 314 may be disposed between the cassette inlet tubing 108A and the loop inlet tubing 108B of the extracorporeal tubing circuit (see FIG. 5A). In at least one exemplary embodiment, the soft cassette 314 includes one or more features for controlling the flow of blood and / or blood components from the donor 102 (FIG. 1) to the apheresis system 200 (FIG. 1) and / or vice versa.

[0081] In at least one exemplary embodiment, the soft cassette assembly 300 includes an air detection sensor 316, a fluid sensor 318, and one or more fluid control valves 320A, 320B, 320C configured to control the routing or flow direction of fluid through the soft cassette 314. In at least one exemplary embodiment, these components may be independently embedded in the cassette access door 304, the base plate 302, and / or a portion of the housing 204 of the apheresis system 200. Similar to the guard closure feature 254 described in connection with FIGS. 2B-2C , the soft cassette assembly 300 may include one or more door closure features 328. Door closure features 328 may include, but are not limited to, magnetic catches, protrusions, tabs and slots, and / or other connecting members. In at least one exemplary embodiment, the door closure feature 328 may include a pressure contact surface configured to retain or at least partially position the soft cassette 314 within the soft cassette assembly 300.

[0082] In at least one exemplary embodiment, valves 320A, 320B, 320C may include, but are not limited to, solenoid valves, linear actuators, pinch valves, clamp valves, tube valves, and / or other actuatable valves configured to selectively alter (e.g., block) fluid passageways (e.g., cross-sectional areas, etc.) associated with particular portions of soft cassette 314.

[0083] In at least one exemplary embodiment, the soft cassette assembly 300 includes a first fluid control valve 320A configured to pinch a portion of the soft cassette 314 adjacent the cassette inlet tube 108A. The second fluid control valve 320B may be configured to pinch a portion of the soft cassette 314 adjacent the loop inlet tube 108B. The retract fluid control valve 320C may be configured to pinch a portion of the soft cassette 314 along a branch tube extending from a point adjacent the cassette inlet tube 108A to a point adjacent the loop inlet tube 108B. In at least one exemplary embodiment, the valves 320A, 320B, 320C each include an extendable finger operable to move from a retracted or partially retracted position to an extended or partially extended position to pinch a portion of the soft cassette 314 contained within the soft cassette assembly 300. It should be understood that while valves 320A, 320B, 320C may completely pinch a flow path within soft cassette 314 (e.g., completely restrict fluid flow through that flow path), valves 320A, 320B, 320C may also be partially actuated to a position that partially restricts fluid flow through a portion of soft cassette 314.

[0084] In at least one exemplary embodiment, the sensors 316, 318 may be one or more of an ultrasonic detector, a pressure sensor, a magnetic position sensor, and / or the like. In some cases, the fluid sensor 318 may be configured to determine whether fluid is present in the soft cassette 314 based on the position of a magnet relative to the portion of the soft cassette 314. For example, when the portion of the soft cassette 314 is filled with fluid, the magnet is positioned at a first position from the surface of the soft cassette 314. However, when the portion of the soft cassette 314 is filled with air, a force from the magnet compresses the portion of the soft cassette 314 to a second position that is closer to the surface of the soft cassette 314 than the first position. In at least one exemplary embodiment, detection of air or fluid by the air detection sensor 316 and the fluid sensor 318 signals and / or triggers an operational step in a control method as described herein.

[0085] Figure 3B is a perspective view of a soft cassette of the soft cassette assembly of Figure 3A, Figure 3C is a cross-sectional view of the soft cassette of Figure 3B along line 3C-3C in Figure 3A, according to at least one exemplary embodiment, and Figure 3D is a cross-sectional view of the soft cassette of Figure 3A along line 3D-3D in Figure 3A, according to at least one exemplary embodiment.

[0086] In at least one exemplary embodiment, the soft cassette 314 may be part of a blood component collection set. For example, the soft cassette 314 is a disposable component used in the blood separation methods described herein. In at least one exemplary embodiment, the soft cassette 314 may be formed from a substantially soft and / or flexible material. The soft material may be chemically inert and / or capable of withstanding sterilization and cleaning procedures, temperatures, and / or processes. The soft cassette 314 may be formed from a thermoplastic material. In at least one exemplary embodiment, the soft cassette 314 may be formed from polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone, thermoplastic elastomers, copolymers, and / or combinations thereof. In at least one exemplary embodiment, the soft cassette 314 is molded, rotomolded, cast, injection molded, or otherwise formed from one or more of the foregoing materials.

[0087] In at least one exemplary embodiment, the soft cassette 314 includes and / or defines a first cassette port 340A (shown in FIGS. 3B-3C), a second cassette port 340B (shown in FIGS. 3B-3C), and a direct flow lumen 350 (shown in FIG. 3C) extending between the first and second cassette ports 340A, 340B. In at least one exemplary embodiment, the first and / or second cassette ports 340A, 340B may be configured to receive and / or be fluidly coupled with one or more tubings of a blood component collection set. In at least one exemplary embodiment, the first cassette port 340A mates with the cassette inlet tubing 108A, and the second cassette port 340B mates with the loop inlet tubing 108B. These connections are airtight and / or liquidtight. In at least one exemplary embodiment, the first and / or second cassette ports 340A, 340B may be or may include openings disposed in a soft cassette 314 configured to elastically stretch around the ends of tubing (e.g., cassette inlet tube 108A, loop inlet tube 108B, etc.).

[0088] In at least one exemplary embodiment, blood supplied by donor 102 (shown in FIG. 1 ) may be directed along one or more fluid pathways disposed within soft cassette 314. In one embodiment, blood may be directed along direct flow lumen 350 from first cassette port 340A to second cassette port 340B. In some embodiments, this flow path may direct blood through first chamber or drip chamber 354 of soft cassette 314. In some embodiments, blood and / or other fluids returned to donor 102 may be directed along direct flow lumen 350 from second cassette port 340B to first cassette port 340A.

[0089] In at least one exemplary embodiment, the soft cassette 314 includes a fluid flow bypass path provided by a first bypass branch 358 (shown in FIGS. 3B, 3D ) having a bypass flow lumen 360 (shown in FIG. 3D ) fluidly connected to a portion of the direct flow lumen 350 adjacent to or as part of the first cassette port 340A. In some embodiments, the bypass flow lumen 360 extends from a point on the direct flow lumen 350 adjacent to the first cassette port 340A, along the first bypass branch 358, through a second chamber or fluid pressure annulus 362 (shown in FIGS. 3B, 3D ), to a second bypass branch 364 (shown in FIGS. 3B, 3D ), and then reconnects to the direct flow lumen 350 at a point adjacent to or as part of the second cassette port 340B. As its name suggests, the bypass flow lumen 364 provides a flow path within the soft cassette 314 that bypasses the drip chamber 354 .

[0090] In at least one exemplary embodiment, controlling the flow paths or directing fluid within the soft cassette 314 includes actuating fluid control valves 320A, 320B, 320C (shown in FIG. 3A ) of the soft cassette assembly 300 to interact with various flexible regions 370A, 370B, 370C (shown in FIG. 3B ) to block and / or open various portions of the direct flow lumen 350 and / or the bypass flow lumen 360. The first flexible region 370A provides a pinch valve region at a point along the direct flow lumen 350 between the first cassette port 340A and the drip chamber 354 near the first cassette end 372 of the soft cassette 314. When the first fluid control valve 320A is actuated, the valve 320A pinches the direct flow lumen 350 with the first flexible region 370A, thereby restricting or completely stopping fluid flow at this point within the soft cassette 314. The second flexible region 370B provides a pinch valve region at a point on the direct flow lumen 370 between the second cassette port 340B and the drip chamber 354 near the second cassette end 374 (e.g., the end opposite the first cassette end 372). When the second fluid control valve 320B is actuated, the valve 320B pinches the direct flow lumen 370 with the second flexible region 370B, thereby restricting or completely stopping fluid flow at this point within the soft cassette 314. As can be seen, the third flexible region 370C, located adjacent to the fluid pressure ring 362 and along the first bypass branch 358, can provide a pinch valve region at a point on the bypass flow lumen 360. When the retract fluid control valve 320C is actuated, the valve 320C can pinch the bypass flow lumen 360 with this third flexible region 370C, thereby restricting or completely stopping the flow of fluid through the bypass flow lumen 360.

[0091] 3C along a plane extending through direct flow lumen 350 and drip chamber 354, direct flow lumen 350 extends from first cassette port 340A through inner chamber volume 376 of drip chamber 354 to second cassette port 340B. Direct flow lumen 350 is formed as a fluid passageway extending inside first tubing section 378, inner chamber volume 376, and second tubing section 379 of soft cassette 314.

[0092] In at least one exemplary embodiment, the bypass path of the soft cassette 314 includes a hydraulic ring 362 through which fluid can flow from the first bypass branch 358 to the second bypass branch 364 and / or vice versa. In at least one exemplary embodiment, a pressure diaphragm 380 may be formed in the material of the soft cassette 314 within or adjacent to the hydraulic ring 362. The hydraulic ring 362 and pressure diaphragm 380 are shown in the cross-sectional elevation view of FIG. 3D taken along a plane extending through the hydraulic ring 362 and portions of the first and second bypass branches 358, 364.

[0093] In at least one exemplary embodiment, pressure diaphragm 380 provides a contact or measurement surface for fluid sensor 318 to detect whether fluid pressure annulus 362 and / or bypass flow lumen 360 contain a predetermined amount of fluid, a predetermined amount of air, and / or a combination thereof. As previously described, when fluid fills a portion of fluid pressure annulus 362, the fluid can offer a greater resistance to movement than when fluid pressure annulus 362 is filled with air. This difference in resistance is measured by fluid sensor 316, thereby determining the amount and / or type of fluid (e.g., air, blood, etc.) in bypass flow lumen 360 and / or fluid pressure annulus 362.

[0094] Centrifuge Assembly Example 4A is a perspective view of an exemplary centrifuge assembly 400 for use with apheresis system 200, according to at least one exemplary embodiment of the present disclosure. The centrifuge assembly 400 may be disposed within an interior space of the apheresis system 200. The interior space may be at least partially enclosed by one or more elements of the housing 204 and / or the centrifuge chamber. Access to the interior space and the centrifuge assembly 400 may be provided by an access panel 224 disposed on the front portion 202 of the apheresis system 200. For example, in FIG. 4A , the access panel 224 is shown in an open position, opened along a hinge axis 226. The hinge axis 226 may correspond to a door hinge, a continuous hinge, a clean room hinge, and / or other panel hinge.

[0095] The centrifuge assembly 400 is operably mounted inside the apheresis system 200 so that the centrifuge assembly 400 can rotate relative to the housing 204 and / or other elements of the apheresis system 200. One or more portions of a blood component collection set (e.g., the blood component collection set 500 shown in FIGS. 5A-5H ) are attached to the centrifuge assembly 400 by routing tubing (e.g., the inlet tubing 108B and the outlet tubing 112) into the interior space of the apheresis system 200 (e.g., through the opening 220 shown in FIG. 2A ) and connecting a portion of the blood component collection loop 520 to the locking loop connector 402 and inserting the blood component collection bladder 536 into the filler 460. The locking loop connector 402 maintains the inlet tubing 108B and the outlet tubing 112 in a fixed position and prevents kinking of the tubing 108B, 112 outside the apheresis system 200. In at least one exemplary embodiment, the blood component collection loop 520 may be interconnected to the fixed loop connection 402 via one or more key or positive location features.

[0096] For illustrative purposes, Figures 4B-4C show the centrifuge assembly 400 separated from the apheresis system 200. The centrifuge assembly 400 includes a centrifuge split housing 404 having a lower housing 404A pivotally connected to an upper housing 404B. The upper housing 404B can be opened to provide access for loading a blood component collection bladder (e.g., the blood component collection set 500 shown in Figures 5A-5H) into the centrifuge assembly 400. In at least one exemplary embodiment, the upper housing 404B pivots about a split housing pivot axis 406 (e.g., configured as a hinge, pin, fastener, shoulder bolt, etc.).

[0097] Each half of the centrifuge split housing 404 (e.g., the lower housing 404A and the upper housing 404B) may be configured to lock and / or unlock relative to one another. Unlocking the upper housing 404B relative to the lower housing 404A provides access to the interior of the centrifuge assembly 400. This selective locking may be achieved by rotating the upper housing 404B relative to the lower housing 404A about the centrifuge rotation axis 430. While FIGS. 4B-4C show the centrifuge split housing 404 in an unlocked state, it should be understood that the upper housing 404B can be rotated (e.g., counterclockwise) about the centrifuge rotation axis 430 to engage one or more locking tabs 428 or locking elements on the upper housing 404B with locking slots 432 disposed on the lower housing 404A (e.g., as shown in FIG. 4C). When upper housing 404B is in the unlocked position, it can be opened or pivoted about split housing pivot axis 406 to load blood component collection loop 520 and / or blood component collection bladder 536 into centrifuge assembly 400. When upper housing 404B is in the locked position, it is rotationally locked relative to lower housing 404A, and the two halves of centrifuge split housing 404 are locked together and rotate as a unit during centrifugation or blood separation operations.

[0098] The centrifuge assembly 400 may include at least one clockwise rotation stop 408A, counterclockwise rotation stop 408B, upper housing clockwise rotation flag 410A, and / or upper housing counterclockwise rotation flag 410B. In at least one exemplary embodiment, the rotation stops 408A, 408B are rotationally fixed relative to the centrifuge rotation axis 430 of the lower housing 404A. The rotation flags 410A, 410B are attached to or formed on the upper housing 404B and configured to contact the respective rotation stops 408A, 408B when locking and / or unlocking the two halves of the centrifuge split housing 404 together to prevent over-rotation of the upper housing 404B relative to the lower housing 404A. For example, when rotating the upper housing 404B in a clockwise or unlocked direction about the centrifuge rotation axis 430, a portion of the upper housing clockwise rotation flag 410A may contact the clockwise rotation stop 408A to prevent further rotation in the clockwise direction. Additionally or alternatively, when rotating the upper housing 404B in a counterclockwise or locked direction about the centrifuge rotation axis 430, a portion of the upper housing counterclockwise rotation flag 410B may contact the counterclockwise rotation stop 408B to prevent further rotation in the counterclockwise direction. In at least one exemplary embodiment, the centrifuge split housing 404 includes one or more locking elements configured to maintain the halves of the centrifuge split housing 404 in a locked state while the locking elements are engaged.

[0099] In at least one exemplary embodiment, the centrifuge split housing 404 includes a pull ring 412 attached to a portion of the upper housing 404B for rotating the upper housing 404B relative to the lower housing 404A about the split housing pivot axis 406. The pull ring 412 includes an opening through which a user can insert a finger to apply a pulling force to the upper housing 404B, which is rotationally unlocked.

[0100] The centrifuge assembly 400 may include a rotor motor assembly 414 that is controlled and / or powered via an electrically interconnected electrical cable 420. The electrical cable 420 includes a connector that attaches to a controller, processor, and / or power source. The electrical cable 420 may carry power and / or data signals between the rotor motor assembly 414 and one or more controllers / processors of the apheresis system 200. The rotor motor assembly 414 may be configured as an electric motor and / or a portion of an electric motor that rotates the entire centrifuge assembly 400 relative to the apheresis system 200 (e.g., relative to a portion of the housing 204 and / or the base of the apheresis system 200). In other words, the rotor motor assembly 414 includes one or more components that rotate the centrifuge assembly 400 (e.g., both halves of the centrifuge split housing 404 together) within the apheresis system 200.

[0101] As described herein, centrifuge assembly 400 may include one or more features for guiding, containing, and / or positioning elements of a blood component collection set relative to centrifuge partition housing 404. For example, FIG. 4B shows blood component collection loop 520 captured in an operative position within loop rotation positioning guide 424 comprising loop capture arm 416. Loop rotation positioning guide 424 includes a plurality of bearings 417 and / or bearing surfaces positioned to at least partially support blood component collection loop 520 in the operative position. In the operative position, blood component collection loop 520 is able to twist along its length within the support provided by bearings 417 of loop rotation positioning guide 424. For example, blood component collection loop 520 is fixedly attached at one end to fixed loop connection 402 of apheresis system 200, while the other end of blood component collection loop 520 is attached to filler 460 (e.g., an internal rotating component of centrifuge assembly 400). As the centrifuge assembly 400 rotates during centrifugation, twisting of the blood component collection loop 520 between the locking loop connection 402 and the connection at the filler 460 causes the filler 460 to rotate relative to the centrifuge split housing 404 of the centrifuge assembly 400. In at least one exemplary embodiment, the low inertia of the filler 460 coupled with the twisting of the blood component collection loop 520 as the centrifuge assembly 400 rotates within the apheresis system 200 causes the filler 460 to rotate in the same rotational direction at an angular velocity that is twice the angular velocity of the centrifuge split housing 404. In this example, as the centrifuge split housing 404 rotates counterclockwise about the centrifuge axis of rotation 430 at a first angular velocity 1ω, the filler 460 rotates within the centrifuge split housing 404 in the counterclockwise direction at a second angular velocity 2ω (e.g., approximately twice the first angular velocity).

[0102] The centrifuge assembly 400 may include one or more balancing features, elements, and / or structures disposed about the centrifuge axis 430 of the centrifuge assembly 400. These balancing features may axially balance the centrifuge assembly 400 so that it is substantially vibration-free relative to the apheresis system 200 when rotated about the centrifuge axis 430. In at least one exemplary embodiment, a centrifuge balance weight 418 is attached to a portion of the centrifuge housing 404 (e.g., the lower housing 404A and / or the upper housing 404B, etc.). The centrifuge balance weight 418 may be custom-tuned for the centrifuge assembly 400, and thus may be selectively attached and detached from the centrifuge assembly 400. The adjustment of the centrifuge balance weight 418 may be calculated and / or experimentally derived to provide a perfectly balanced centrifuge assembly 400, particularly when equipped with one or more elements of a blood component collection set.

[0103] 4C shows a rear perspective view of centrifuge assembly 400 in accordance with at least one exemplary embodiment of the present disclosure. A portion of filler 460 is visible through an opening in upper housing 404B. Blood component collection loop 520 is shown in initial loop loading position 520A, with a first end interconnected with filler 460 and a second end fixedly attached to fixed loop connector 402 (not shown). Blood component collection loop 520 is shown passing through loop access clearance 436 in centrifuge partition housing 404. When blood component collection loop 520 is loaded in loop loading position 520A, a portion of blood component collection loop 520 is partially contained, held, and / or supported by loop storage bracket 426. The loop storage bracket 426 includes one or more bearings 417 (e.g., roller bearings, ball bearings, needle bearings, etc., and / or assemblies thereof) or bearing surfaces arranged to at least partially support the blood component collection loop 520 as it twists relative to the centrifuge assembly 400. In at least one exemplary embodiment, the blood component collection loop 520 rotates (e.g., in an installed or mounted state and / or condition) about an axis extending along the length of the flexible loop 524 to enable relative rotational movement of the flexible loop 524 with respect to the loop rotation positioning guide 424. For example, the loop does not "twist up," but rather actually rotates or rolls relative to the loop rotation positioning guide 424 (e.g., a support structure) between the one or more bearings 417. This rotation or twisting without wrapping or twisting of the flexible loop 524 may be referred to herein as "twist." This twisting allows flexible loop 524 to impart a rotational force to filler 460 without substantially reducing the inner diameter of the lumen of flexible loop 524. In some cases, the inner diameter of the lumen of flexible loop 524 does not reduce at all.

[0104] As previously described, when the upper housing 404B is rotated from the rotationally unlocked position shown in FIGS. 4B-4C to the rotationally locked position, the locking tab 428 of the upper housing 404B engages with the locking slot 432 of the lower housing 404A. Additionally or alternatively, when moved to the rotationally locked position, the loop storage bracket 426, along with the blood component collection loop 520 and the upper housing 404B, rotates to a position aligned with the loop rotation positioning guide 424 along the loop engagement position 520B. In at least one exemplary embodiment, the loop capture arm 416 can guide the blood component collection loop 520 onto the bearing 417 and / or bearing surface of the loop rotation positioning guide 424 as the upper housing 404B and blood component collection loop 520 rotate to the loop engagement position 520B. Further details regarding the installation of the blood component collection loop 520 are described in conjunction with FIGS. 6A-7B.

[0105] 4D-4F illustrate various schematic cross-sectional views through the center of the centrifuge assembly 400 (e.g., bisecting the centrifuge assembly 400 by the centrifuge rotation axis 430). As previously described, the centrifuge assembly 400 includes a lower housing 404A pivotally attached to an upper housing 404B by a split housing pivot 406 or hinge. The upper housing 404B is attached to an upper housing adapter 440 that is rotatably connected to an upper housing bushing block 442 that is attached to a pull ring 412. In at least one exemplary embodiment, a bearing 417, bushing, or bearing surface may be disposed between the upper housing adapter 440 and the upper housing bushing block 442 to allow the upper housing 404B to rotate from a locked position to an unlocked position and vice versa along the centrifuge rotation axis 430. The pull ring 412 may be rotationally fixed relative to the lower housing 404A about the centrifuge rotation axis 430. In at least one exemplary embodiment, the upper housing adapter 440 and the upper housing 404B may be formed from a unitary structure.

[0106] The filler 460 is fixedly attached to a filler mandrel 434 that is configured to rotate relative to the upper housing 404B about the centrifuge rotation axis 430. In at least one exemplary embodiment, the filler mandrel 434 may be formed from a portion of the filler 460. In either case, one or more mandrel support bearings 444 are disposed between the filler mandrel 434 and the upper housing adapter 440 to allow the filler 460 to rotate about the centrifuge rotation axis 430 inside the centrifuge split housing 404 and centrifuge assembly 400. In at least one exemplary embodiment, the filler mandrel 434 may be held in an operating position via at least one retaining nut 438. The filler 460 and the filler mandrel 434 can rotate together relative to the centrifuge split housing 404.

[0107] 4D shows a schematic cross-sectional view of the centrifuge assembly 400 in a closed state (e.g., before the blood component collection loop 520 is attached). To unlock the upper housing 404B from the lower housing 404A, the operator pulls the pull ring 412 to rotate the entire upper housing 404B and filler 460 about the split housing pivot axis 406. In at least one exemplary embodiment, the upper housing 404B and filler 460 are partially opened by rotating the components in the opening direction 446 about the split housing pivot axis 406. For example, as shown in FIG. 4E , which shows the centrifuge assembly 400 in a partially opened state, the upper housing 404B and filler 460 are rotated away from the lower housing rotation axis 430A. In this position, the filler 460 may be allowed to rotate about the filler rotation axis 430B. When the lower housing 404A and the upper housing 404B are in the closed position, the lower housing rotation axis 430A and the filler rotation axis 430B are aligned (coincident or nearly coincident) to form the centrifuge rotation axis 430.

[0108] By continuing to rotate the upper housing 404B and the filler 460 in the opening direction 446 about the y-axis of the split housing pivot shaft 406 (e.g., by continuing to pull the pull ring 412), the upper housing 404B and the filler 460 can be rotated approximately 180 degrees from the closed position shown in FIG. 4D . As shown in FIG. 4F , the centrifuge assembly 400 is in an open or loading state. In this position, the upper housing 404B and the filler 460 can be rotated outside the interior space of the apheresis system 200. For example, at least a portion of the upper housing 404B and / or the filler 460 is positioned through the open space of the open access panel 224. In this position, the loading access area 450 is provided for the loop connection area 454 of the filler 460. As can be seen, the open position of the upper housing 404B allows easy access to the interior of the upper housing 404B and the filler 460. Among other things, this arrangement allows sufficient space for the operator to attach blood component collection loop 520 to filler 460 at loop connection region 454 .

[0109] Referring to FIG. 4G , a perspective view of a filler 460 for a centrifuge assembly 400 is shown, in accordance with at least one exemplary embodiment of the present disclosure. In at least one exemplary embodiment, the filler 460 is formed from a lightweight material, such as plastic, carbon fiber, aluminum, or the like. In at least one exemplary embodiment, the filler 460 may be three-dimensionally (3D) printed by a 3D printer. For example, the filler 460 may be manufactured by additive manufacturing techniques or systems, such as fused deposition modeling (FDM), selective laser sintering (SLS), stereolithography (SLA), and / or an additive manufacturing machine. These additive rapid prototyping manufacturing techniques, among others, enable more complex geometries for the filler 460 that may not be possible using conventional machining or manufacturing processes. In at least one exemplary embodiment, the material of the filler 460 is selected based on the desired mass of the filler 460, the desired physical strength of the manufactured filler 460, and / or suitable materials for use in manufacturing.

[0110] The filler 460 includes a loop connection region 454 disposed generally in the center of the filler 460. The loop connection region 454 includes one or more key features or positive positioning features for engaging a portion of the blood component collection loop 520. As shown in FIG. 4G , the loop connection region 454 includes a first positive positioning feature 478 disposed along a portion of the central axis of the filler 460. The first positive positioning feature 478 may be a keyway, groove, slot, or other feature for engaging with a mating feature disposed on the blood component collection loop 520. In at least one exemplary embodiment, the filler 460 has a second positive positioning feature 480 in the loop connection region 454. The positioning features 478, 480 prevent rotation of the blood component collection loop 520 at the loop connection region 454 and / or prevent the blood component collection loop 520 from disengaging from the loop connection region 454 of the filler 460.

[0111] In at least one exemplary embodiment, the filler 460 includes a collect insert channel 466 configured to receive and at least partially accommodate a blood component collection bladder of the blood component collection set, more specifically, a blood component collection loop 520. The collect insert channel 466 is configured as a groove, or slot, extending outward in a generally spiral manner from the center of the filler 460. In at least one exemplary embodiment, the collect insert channel 466 follows a generally spiral-shaped path including a first spiral path portion extending outward along the circumferential length of the collect insert channel 466 from the center of the filler 460 to a generally constant radius (e.g., relative to the center of the filler 460). In either case, the path is referred to herein as a spiral path or a generally spiral path. The collect insert channel 466 begins at a channel inlet 468 near the center of the filler body 464 and terminates at a channel end 472 near a point farthest from the center of the filler body 464. As shown in FIGS. 4G-4I , the collect insert channel 466 extends along a generally helical path 490 extending from a point near the filler axis of rotation 430B to the channel end 472. The generally helical path 490 includes a channel path bend 476 at a point near or adjacent to the channel end 472. The channel path bend 476 increases the separation distance of the collect insert channel 466 from the center of the filler body 464, thereby increasing the centripetal and centrifugal forces at the channel end 472 of the collect insert channel 466. In at least one exemplary embodiment, the channel path bend 476 corresponds to a critical inlet / outlet port at a maximum radial position within a blood component collection bladder 536 that is at least partially inserted or disposed within the collect insert channel 466 of the filler 460. In at least one exemplary embodiment, the filler 460 may include one or more filler counterbalance projections 482 disposed on or near a portion of the filler body 464. These filler balancing protrusions 482 can result in the filler 460 being axially balanced (e.g., balanced about the filler rotation axis 430B), particularly when the collection insert channel 466 contains a blood component collection bladder and fluid (e.g., blood, blood components, etc.).

[0112] 4I is a schematic plan view of a generally helical-shaped receiving or collection insert channel 466 in a filler 460, in accordance with at least one exemplary embodiment of the present disclosure. The schematic plan view illustrates a first distance R1 of the collection insert channel 466 from the center of the filler body 464 at a first point along the generally helical path 490 (e.g., near the filler axis of rotation 430B) and a second distance R2 of the collection insert channel 466 from the center of the filler body 464 past a point near the channel path bend 476. As shown in FIG. 4I, the second distance R2 is farther from the center of the filler body 464 than the first distance R1. This increase in distance allows the channel to experience a higher centripetal or centrifugal force at a point at or near the channel end 472 than at any other point along the generally helical path 490. In at least one exemplary embodiment, the ends of the blood component collection bladder are approximately coincident with the channel ends 472, thereby providing the greatest blood separation forces at the ends of the bladder.

[0113] 4J-4L illustrate various elevational cross-sectional views of the filler 460, and more specifically, the collect insert channel 466 and filler insert chamber 492 disposed inside the filler body 464. In at least one exemplary embodiment, the collect insert channel 466 includes a cross-section or shape that generally follows a generally helical path 490 within the filler body 464. The collect insert channel 466 includes an insert groove configured to receive a generally flat or unfilled blood component collection bladder. The blood component collection bladder is inserted within the collect insert channel 466 and into a filler insert chamber 492 formed within the filler body 464 along the generally helical path 490. The filler insert chamber 492 is defined by one or more sidewalls 494, 496 that form a cavity that follows the generally helical path 490. 4K , the filler insert chamber 492 includes an inner chamber wall 494 spaced a given distance from at least one outer chamber wall 496. The filler insert chamber 492 may be formed in the filler 460 by 3D printing the filler 460 and / or by one or more other metal or plastic forming processes (e.g., casting, molding, molding, etc.). In at least one exemplary embodiment, the filler insert chamber 492 includes one or more insertion guide features 498. These insertion guide features 498 are configured to guide, position, and / or seat a blood component collection bladder inside the filler insert chamber 492 of the filler 460. The insertion guide feature 498 is shown as a chamfered lead-in feature of the filler insertion chamber 492, but may also include one or more radii, chamfers, slopes, tapers, draft angles, receptacles, grooves, and / or other shaped features configured to guide and / or direct a portion of the inserted blood component collection bladder.

[0114] 4L illustrates different states of a fluid collection bladder (e.g., a blood component collection bladder) disposed within the collect insert channel 466 and filler insert chamber 492 of the filler 460. As previously described, the blood component collection bladder is inserted into the collect insert channel 466 in a generally flat, or unfilled, state S1. In the generally flat state S1, the blood component collection bladder is sized to fit into the upper opening of the collect insert channel 466 and be maintained in a pre-filled state within the filler insert chamber 492. As the filler 460 rotates and begins separating blood components from the blood provided by the donor 102, the blood component collection bladder expands from the generally flat, first state S1 to an expanded, or filled state S2. In at least one exemplary embodiment, the blood component collection bladder can be expanded with blood and / or blood components until the walls of the blood component collection bladder contact the walls 494, 496 of the filler insert chamber 492. In at least one exemplary embodiment, the shape of the filler insertion chamber 492 is designed to optimize the amount of fluid that can be collected and / or separated within the filler insertion chamber 492 (e.g., to maximize the amount of fluid while minimizing the amount of material for the filler 460).

[0115] Example of a blood component collection set 5A-5H illustrate a blood component collection set 500 prepared in accordance with at least one exemplary embodiment of the present disclosure. The blood component collection set 500 includes various connections, including, for example, tubing and connectors. For example, as shown, the blood component collection set 500 can include one or more tubing, such as cassette inlet tubing 108A, loop inlet tubing 108B, anticoagulant tubing 110, loop outlet tubing 112, saline tubing 116, and / or plasma tubing 120, and one or more connectors, such as tubing connector 106 and / or saline-plasma tubing y-connector 280. The blood component collection set 500 can also include one or more other connectors, such as first tubing fitting 504, second tubing fitting 508, bag fitting 512, system securement loop connector 528, and / or filler loop connector 532. The various connections can fluidly connect the soft cassette 340 and the blood component collection loop 520.

[0116] One or more tubes, including cassette inlet tubing 108A, loop inlet tubing 108B, anticoagulant tubing 110, loop outlet tubing 112, saline tubing 116, and / or plasma tubing 120 (collectively referred to as "tubes"), each have a central lumen configured to carry a fluid therethrough. The tubes may comprise one or more polymeric materials, including, for example, polyvinyl chloride (PVC), plasticized polyvinyl chloride, polyethylene, ethylene vinyl acetate (EVA), rubber, copolymers, and combinations thereof.

[0117] One or more connectors, including tubing connector 106, saline / plasma tubing y-connector 280, first tubing fitting 504, second tubing fitting 508, bag fitting 512, system securement loop connector 528, and / or filler loop connector 532 (collectively referred to as "connectors"), are each configured to fluidly interconnect tubing, and / or to fluidly interconnect tubing and other medical accessories, and / or to fluidly interconnect tubing and needles or spikes. For example, a connector may be inserted into a central lumen of the respective tubing and / or may be attached to the exterior of the respective tubing, and / or bag fitting 512 may be configured to be inserted into a receiving bag, such as saline bag 118. In at least one exemplary embodiment, the connectors may include various fittings, including, for example, Luer fittings, twist-connect fittings, and / or other small-bore couplings, to provide versatile and / or reliable interconnections for establishing fluid connections.

[0118] As shown, the blood component collection loop 520 includes a flexible loop 524 disposed between a system fixed loop connector 528 and a filler loop connector 532. The fixed loop connector 528 may be attached to the flexible loop 524 and / or the blood component collection bladder 536 by a mechanical lock, which may be formed of a light-curable adhesive, as described further below. The flexible loop 524 may be configured as a hollow flexible tube configured to receive and / or accommodate at least a portion of the loop inlet tubing 108B and the loop outlet tubing 112. In at least one exemplary embodiment, the flexible loop 524 may be constructed of a highly flexible thermoplastic elastomer for transmitting torsion from the first end toward and to the second distal end of the flexible loop 524. Such an elastomer may provide the flexibility of rubber while maintaining the strength and torque characteristics of plastic. Examples of thermoplastic elastomers may include, for example, copolyesters, DuPont™ Hytre™ thermoplastic elastomers, Eastman Neostar™ elastomers, Celanese Riteflex™ elastomers, TOYOBO PELPRENE™, and / or elastomers from other manufacturers that provide high flexibility and strength properties.

[0119] In at least one exemplary embodiment, blood component collection loop 520 can include a blood component collection bladder 536. Blood component collection bladder 536 has a first end, or bladder loop end 540A, and a second end, or bladder free end 540B. Blood component collection bladder 536 includes a first collection flow chamber 544 extending between bladder loop end 540A and bladder free end 540B and connected to flexible loop 524 via filler loop connector 532. For example, in at least one exemplary embodiment, fluid flows between loop inlet tube 108B and first collection flow chamber 544 via a flow path defined by flexible loop 524, system securement loop connector 528, and filler loop connector 532. Bladder free end 540B of first collection flow chamber 544 includes a flow chamber transition 548. Fluid flowing from bladder loop end 540A through first collection flow chamber 544 to bladder free end 540B can enter second collection flow chamber 552 through flow chamber transition 548. Second collection flow chamber 552 is connected to flexible loop 524 through filler loop connector 532. For example, in at least one exemplary embodiment, fluid flows between loop outlet tubing 112 and second collection flow chamber 552 through a flow path defined by flexible loop 524, system fixation loop connector 528, and filler loop connector 532.

[0120] 5B , the flexible loop 524 may include a first passage 509 configured to receive the loop inlet tubing 108B and a second passage 510 configured to receive the loop outlet tubing 112. For example, in at least some exemplary embodiments, at least a portion of the loop inlet tubing 108B is retained within the first passage 509 of the flexible loop 524 and connected to the first collection flow chamber 544 at the bladder loop end 540A via a filler loop connector 532. Additionally, or alternatively, at least a portion of the loop outlet tubing 112 may be retained within the second passage 510 of the flexible loop 524 and connected to the second collection flow chamber 552 at the bladder loop end 540A via a filler loop connector 532. In this manner, the fluid enters the blood component collection bladder 536 via the first collection flow chamber 544, where it is separated (e.g., into one or more blood components) and conveyed along the second collection flow chamber 552 to the loop outlet tube 112 held within the second pathway 510 of the flexible loop 524.

[0121] As shown, first collection flow chamber 544 is separated from second collection flow chamber 552 via flow chamber separator 542. In at least one exemplary embodiment, flow chamber separator 542 may be a sealed (e.g., heat-sealed) portion of blood component collection bladder 536. For example, in at least one exemplary embodiment, blood component collection bladder 536 may include or be composed of one or more overlapping and sealed layers of material. The material layers may include one or more polymeric materials. For example, in at least one exemplary embodiment, the material layers may include polyvinyl chloride (PVC), plasticized polyvinyl chloride, polyethylene, ethylene vinyl acetate (EVA), thermoplastics, thermoplastic elastomers, copolymers, and combinations thereof.

[0122] The layers of material are shaped (e.g., cut or otherwise formed) and sealed along one or more edges to form the blood component collection bladder 536. As shown in Figures 5C and 5D, a flow chamber separator 542 can be formed within the blood component collection bladder 536 by sealing one or more layers of material to one or more other layers of material and / or by sealing one or more first portions of a single layer of material to one or more second portions of the single layer of material along one or more preselected paths. For example, as shown in Figure 5D, which shows the blood component collection bladder 536 before sealing, the flow chamber separator 542 can be formed as a sealed region of material by joining material 536A on a first side of the bladder to material 536B on a second side of the bladder. Additionally, the material 536A on the first side of the bladder and the material 536B on the second side of the bladder can be sealed at one or more edges 554A, 554B to form the top and bottom of the blood component collection bladder 536. 5A and 5B, the seal defining flow chamber separator 542 does not extend the entire length of blood component collection bladder 536, thereby defining flow chamber transition 548 so that fluid can pass between first collection flow chamber 544 and second collection flow chamber 552.

[0123] Once formed, the width (WB) of the bladder may correspond to the width of the first collect flow chamber 544 and / or the second collect flow chamber 552 in the unexpanded state S1 (see, e.g., FIG. 4L). During operation, as fluid fills at least a portion of the blood component collection bladder 536, the dimension of the width (WB) of the bladder may increase from the dimension shown in FIG. 5C. For example, in at least one exemplary embodiment, the width (WB) of the bladder can increase substantially to the size of the filler insert chamber 492 of the filler 460. In at least one exemplary embodiment, the sealed or welded portions of the blood component collection bladder 536 are supported within the filler 460. For example, as shown in FIGS. 5G and 5H, the top of the filler 460 supports the top two seal portions 554A, 542, and the bottom of the filler 460 supports the bottom seal portion 554B.

[0124] In at least one exemplary embodiment, blood component collection loop 520 may include one or more positive positioning features (also referred to as key features) 530A, 530B configured to assist in positively positioning multiple locations of blood component collection loop 520 relative to apheresis system 200, specifically, filler 460 of centrifuge assembly 400. For example, as shown, blood component collection loop 520 includes a first connector positioning feature 530A on or near system securement loop connector 528 and a second connector positioning feature 530B on or near filler loop connector 532. Positioning features 530A, 530B may be configured as keys, tabs, and / or other protrusions extending from connectors 528, 532. In at least one exemplary embodiment, the second connector positioning feature 530B may include a feature that interconnects with (e.g., mates with) the first positive positioning feature 478 and / or the second positive positioning feature 480 of the loop connection region 454 of the filler 460.

[0125] 5E-5H show various perspective views of blood component collection loop 520 in a bent state, and also show bent blood component collection bladder 536 of blood component collection loop 520 when inserted into filler 460 of centrifuge assembly 400. Various components of blood component collection loop 520 may be flexible and / or may be formed or shaped by the application of force. In at least one exemplary embodiment, this flexibility may be elastic such that the components are not permanently deformed as various portions of blood component collection loop 520 take shape.

[0126] 5E illustrates blood component collection loop 520 in a bent state. For example, in FIG. 5E, flexible loop 524 is shown resiliently bent along its length, and blood component collection bladder 536 is shown with multiple bends or curves along its length. Although one or more of the various components of blood component collection loop 520 are in a bent state, flexible loop 524 nevertheless delivers fluid to blood component collection bladder 536, e.g., via loop inlet tubing 108B, and / or conveys fluid away from blood component collection bladder 536, e.g., via loop outlet tubing 112.

[0127] In at least one exemplary embodiment, the blood component collection loop 520 may be pre-shaped to fit within the collect insert channel 466 of the filler 460 of the centrifuge assembly 400, as shown in FIG. 5F , for example. This pre-shaping may include bending the blood component collection bladder 536 of the blood component collection loop 520 to match the generally helical path 490 of the collect insert channel 466. Once pre-shaped, the functional portions of the blood component collection loop 520 may be aligned with one or more functional portions of the filler 460, as shown in FIG. 5G . For example, in at least one exemplary embodiment, the filler loop connector 532 of the blood component collection loop 520 is aligned with the loop connection region 454 of the filler 460 such that the second connector positioning feature 530B is aligned to engage the first positive positioning feature 478. Additionally or alternatively, the blood component collection bladder 536 may be shaped or formed (e.g., manually or automatically) to match the generally helical path 490 of the collect insert channel 466 in the filler 460. In at least one exemplary embodiment, this shaping or forming may include aligning the free bladder end 540B of the blood component collection bladder 536 with the channel end 472 of the collect insert channel 466 in the filler 460. When the components are roughly aligned with one another, the blood component collection loop 520 may be moved in a direction toward the collect insert channel 466 and loop connection region 454, as shown in FIG. 5G. In at least one exemplary embodiment, the first positive positioning feature 478 interconnects with and / or retains the second connector positioning feature 530B of the filler loop connector 532 of the blood component collection loop 520 as the filler loop connector 532 is moved into the loop connection region 454 of the filler 460. This interconnection prevents the filler loop connector 532 from rotating relative to the filler 460. In at least one exemplary embodiment, this interconnection retains the filler loop connector 532 of the blood component collection loop 520 within the loop connection region 454 of the filler 460. FIG. 5H shows the blood component collection loop 520 attached to the filler 460.The system fixation loop connector 528 and the filler loop connector 532 can cooperate to transmit torque applied to the flexible loop 524 to the blood component collection bladder 536 and the filler 460 .

[0128] In at least one exemplary embodiment, fluid (e.g., blood and / or blood components) in blood component collection bladder 536 contained within filler insert chamber 492 of filler 460 can travel along first collection flow chamber 544 toward bladder free end 540B, around the end of flow chamber separator 542 (e.g., following blood component travel direction 546) to second collection flow chamber 552. In this example, blood components (e.g., plasma, etc.) travel along second collection flow chamber 552 back toward the center of filler body 464 in a generally spiral path 490 and through loop outlet tubing 112 (e.g., toward plasma collection bottle 122).

[0129] Example of a centrifuge assembly with loops attached 6A-6C are schematic cross-sectional views of a centrifuge assembly 400 in various loop mounting states, according to at least one exemplary embodiment of the present disclosure. The centrifuge assembly 400 shown in FIGS. 6A-6C corresponds to the centrifuge assembly 400 described above, particularly in connection with FIGS. 4D-4F. In particular, FIG. 6A shows a schematic cross-sectional view of a first loop mounting state, FIG. 6B shows a schematic cross-sectional view of a second loop mounting state, and FIG. 6C shows a schematic cross-sectional view of the second loop mounting state for the centrifuge assembly 400.

[0130] In Figure 6A, the centrifuge assembly 400 is shown in an open, loop-attached position, in which the upper housing 404B is rotated 180 degrees from the closed, or operating, position. This open position corresponds to the position of the centrifuge assembly 400 shown in Figure 4F. However, in Figure 6A, the blood component collection loop 520 is inserted into the filler 460, and the filler loop connector 532 is interconnected to the loop connection region 454 of the filler body 464. The other end of the blood component collection loop 520 is connected to the fixed loop connection portion 402 via the system locking loop connector 528. In this first loop-attached state, the flexible loop 524 is secured against rotation in the fixed loop connection portion 402 but rotates integrally with the filler 460 at the loop connection region 454.

[0131] 6B, the centrifuge assembly 400 is shown in a partially closed position, with the upper housing 404B moving from an open position to a closed or operating position. Rotation of the upper housing 404B allows the flexible loop 524 to move to a stationary position relative to the centrifuge assembly 400. Although the flexible loop 524 is rotationally fixed at the fixed loop connection 402, the filler 460 is free to rotate (e.g., limited only by the rotationally fixed flexible loop 524) about the filler axis of rotation 430B.

[0132] 6C, the centrifuge assembly 400 is shown in a closed or operating position in which the upper housing 404B can be locked to the lower housing 404A (so that the lower housing 404A and upper housing 404B can rotate together about the centrifuge rotation axis 430). In this position, the flexible loop 524 extends from the loop connection region 454 of the filler 460 through the loop access clearance 436 of the centrifuge split housing 404 to the fixed loop connection 402. In at least one exemplary embodiment, the flexible loop 524 is free to move within the loop access clearance 436, with or without contacting one or more portions of the centrifuge split housing 404. In this position, as the centrifuge assembly 400 rotates about the centrifuge axis 430, the flexible loops 524, which are rotationally fixed at the fixed loop connections 402, can twist along their lengths, causing the filler 460 to rotate within the centrifuge assembly 400 (e.g., along the centrifuge axis 430). As previously mentioned, the rotation of the filler 460 relative to the centrifuge assembly 400 may be in a 2:1 ratio. For example, as the centrifuge assembly 400 rotates once, the flexible loops 524, which are rotationally fixed (e.g., fixed at the fixed loop connections 402), will twist (e.g., attempt to untwist from the rotation of the centrifuge assembly 400) at the loop connection regions 454, causing the filler 460 to rotate in the same rotational direction as the centrifuge assembly 400, but approximately two revolutions. This rotation of the filler 460 by twisting the flexible loop 524 along its length does not require an interlock between the centrifuge assembly 400 and the filler 460 .

[0133] Example of a centrifuge assembly with loops attached 7A-7B show schematic plan views of a centrifuge assembly 400 that automatically loads a loop into an operating position for centrifugation (e.g., blood separation). The centrifuge assembly 400 shown in FIGS. 7A-7B may correspond to the centrifuge assembly 400 described and / or illustrated above in connection with FIGS. 4A-4F and 6A-6C. When a blood component collection loop 520 is loaded into the centrifuge assembly 400, as shown in FIG. 6C, a flexible loop 524 is automatically loaded into loop engagement position 520B, as shown in FIGS. 7A-7B.

[0134] In at least one exemplary embodiment, when the upper housing 404B is locked to the lower housing 404A, the flexible loop 524 extends from the loop connection region 454 of the filler 460 to the fixed loop connection 402 of the apheresis system 200. Although the flexible loop 524 may be rotationally secured to the fixed loop connection 402 with the system fixed loop connector 528, the flexible loop 524 passing through the loop access clearance 436 of the centrifuge split housing 404 may not initially be retained or at least partially captured by the loop rotation positioning guide 424 and / or other features of the centrifuge assembly 400. This state of the flexible loop 524 relative to the loop rotation positioning guide 424 or loop arm corresponds to an uncaptured loop state 700A. In other words, flexible loop 524 may be oriented at an angle (α) relative to loop rotation positioning guide 424, loop positioning stop plate 704, and / or one or more loop torsion support bearings 708 or bearing sets. In at least one exemplary embodiment, loop torsion support bearings 708 may correspond to bearings 417 described in connection with FIGS. 4B-4C. A loop storage area or channel may be formed by loop positioning stop plate 704 and / or one or more loop torsion support bearings 708 disposed along the length of upper housing 404B. In at least one exemplary embodiment, this arrangement may be designed to allow for ease of access and / or installation of the loop installation described in connection with FIGS. 6A-6C.

[0135] As the centrifuge assembly 400 is rotated about the centrifuge axis 430 in the loop-filler rotation direction 712, the flexible loop 524 can move from the uncatching loop state 700A to the captured loop state 700B shown in FIG. 7B. This rotation may be caused by an operator rotating the centrifuge assembly 400 and / or the filler 460 in the loop-filler rotation direction 712 and / or by the rotor motor assembly 414 rotating the centrifuge assembly 400 about the centrifuge axis 430. In at least one exemplary embodiment, as the flexible loop 524 rotates in the loop-filler rotation direction 712, an outer portion of the flexible loop 524 contacts the loop positioning stop plate 704 or other rotational stop surface of the loop rotation positioning guide 424.

[0136] With the flexible loop 524 held or at least partially contained within the loop rotational positioning guide 424, a portion of the flexible loop 524 can move within one or more of the loop torsional support bearings 708. As previously described, the flexible loop 524 may be rotationally secured to the fixed loop connection 402 via a first connector positioning feature 530A of a system secure loop connector 528 associated with the blood component collection loop 520. This rotationally secured connection prevents the flexible loop 524 from rotating relative to the apheresis system 200 at the fixed loop connection 402. The other end of the flexible loop 524 may be interconnected at a loop connection region 454 of the filler 460 to allow this end to move with the filler 460 and / or the centrifuge assembly 400. As the centrifuge assembly 400 continues to rotate in the loop-filler rotation direction 712, the force from the flexible loop 524 attempting to unwind or unwind causes the filler 460 and the end of the flexible loop 524 attached to it to rotate.

[0137] In any event, once the fluid separation methods described herein are completed, rotation of the centrifuge assembly 400 is stopped and the centrifuge partition housing 404 is opened to remove the disposable elements of the blood component collection set 500 from the centrifuge assembly 400. In some cases, the flexible loop 524 may be moved from the capture loop state 700B shown in FIG. 7B to the non-capture loop state 700A shown in FIG. 7A by rotating the centrifuge assembly 400 and / or the filler 460 in a direction opposite to the loop-filler rotation direction 712.

[0138] Example of a functional diagram of an apheresis system A functional diagram of an apheresis system 200 is shown in Figure 8 in accordance with at least one exemplary embodiment of the present disclosure. This description illustrates the components previously described in Figures 1-7B in a functional diagram to explain the operation of the system 200 for extracting plasma or other blood components from the whole blood of a donor 102 during an apheresis procedure or process.

[0139] System 200 may include an anticoagulant (AC) pump 216. AC pump 216 pumps fluid from AC bag 114 into AC tubing 110. AC pump 216, AC tubing 110, and / or AC bag 114 may be as described above. AC tubing 110 may also include an AC air detection sensor (ADS) 804 to detect air or fluid within AC tubing 110. AC ADS 804 may be the same or similar in type and / or function to sensor 284 and / or sensor 312 previously described. AC tubing 110 intersects and is fluidly associated with donor supply tubing 104 and cassette inlet tubing 108A at tubing connector 106. Tube connector 106 may be any type of connection between tubing 110, 104, and / or tubing 108A, as previously described.

[0140] Donor supply tube 104 extends from donor 102, which may be punctured with a lumen needle or other device to allow whole blood to flow from donor 102 into apheresis system 200 and blood components to flow back to donor 102. Tubing 108A extends to soft cassette 340. Additionally, donor air detection sensor 312 may be positioned on or within tubing 108A to detect the presence of fluid and / or air within tubing 108A.

[0141] As previously described, soft cassette 340 may include a "Y" connector or section or branch that may function as a "Y" connector or section or branch, and / or may include a first cassette port 360A that may be generally adjacent to a "Y" connector or section or branch that separates tubing 108A into a first bypass branch 358A and a first tubing section 368A (the "Y" section is designated by reference character 360A). The two tubing sections 358, 368 are reconnected at a second cassette port 360B that may include a second "Y" connector or section that may also function as a second "Y" connector or section, and / or may be generally adjacent to the second "Y" connector or section (the second "Y" section is designated by reference character 360B). Tube 358 is divided in two by fluid sensor 316, which separates tube 358 into first and second bypass branches 358A and 358B. Similarly, tube 368 is divided in two by drip chamber 354, which separates tube 368 into first and second tube sections 368A and 368B.

[0142] First tubing section 368A can include first fluid control valve 320A. Second tubing section 368B can similarly include second fluid control valve 320B. First bypass branch 358A can similarly include lead fluid control valve 320C. Thus, based on the configuration of system 200 and depending on the operation of system 200, various sections of tubing 368A, 358A, 358B, 368B can be isolated by valves 320A, 320B and / or valve 320C.

[0143] A drip chamber 354 may be disposed between the first tubing section 368A and the second tubing section 368B. The drip chamber 354 may collect a predetermined amount of whole blood and / or high hematocrit blood (blood with a high percentage of red blood cells) depending on the operation of the system 200, as described below. A fluid sensor 316 may be disposed between the first bypass branch 358A and the second bypass branch 358B, as previously described.

[0144] The inlet tube 108B can connect to the second cassette port 360B and can connect the soft cassette 340 to the flexible loop 524. The inlet tube 108B can also include a sensor 808 disposed on or within the tube 108B prior to connection with the system secure loop connector 528 of the flexible loop 524 and disposed with the tube 108B. The pressure sensor (CPS) 808 can detect one or more of, but not limited to, the pressure, presence or absence of fluid or air within the tube 108B, and / or possibly other properties of the fluid. Additionally, the draw pump 208 can pump fluid through the tube 108B away from or to the soft cassette 340.

[0145] Two or more different tubes can be connected to the flexible loop 524 via the system fixation loop connector 528, and two or more different tubes can supply fluid to or receive fluid from the blood component collection bladder 536. An outlet tube 112 exits the system fixation loop connector 528 from the flexible loop 524. This outlet tube 112 includes another line sensor 812 disposed on or within the outlet tube to detect fluid, air, intracellular concentrations, color, and / or color changes in the fluid exiting the flexible loop 524. The line sensor 812 may be the same or similar in type and / or function to the previously described sensors 804, 312, 320, 808, and / or sensor 284. A second CPS sensor 816 or fluid sensor may be disposed in or on the line 112. Sensor 816 may detect one or more of, but is not limited to, the presence or absence of fluid in tube 112, the pressure, and / or other properties of the fluid in tube 112. Similarly, sensor 816 may be the same as or similar in type and / or function to sensors 804, 312, 320, 808, 812 and / or sensor 284 previously described.

[0146] The outlet tube 112 may then flow into a plasma air detection sensor 284 before a saline-plasma tubing y-connector 280 separates the outlet tube 112 into a saline tubing 116 and a plasma tubing 120. A return pump 212 may interface with the outlet tube 112, allowing fluid or air to flow through the outlet tube 112 from a flexible loop 524 or from the saline bag 118 and / or plasma collection bottle 122.

[0147] The saline bag 118 and associated tubing may be as previously described and may supply saline to the original donor 102 through the system 200. A saline flow control valve 288 may isolate the saline bag 118 from the remainder of the system 200. Additionally, the plasma collection bottle 122 may receive plasma from the flexible loop 524 as it is processed or separated from the whole blood. The plasma collection bottle 122 may be selectively isolated from the system by the plasma flow control valve 286.

[0148] Electrical and Control Systems An embodiment of an electrical and control system 900 for controlling the functions of apheresis system 200 may be shown in Figure 9 according to an embodiment of the present disclosure. Control system 900 may include one or more nodes, which may include various hardware, firmware, and / or software configured to control and / or communicate with the mechanical, electromechanical, and electrical components of apheresis system 200.

[0149] Each node may function to control a different portion of the apheresis system 200. For example, the control system 900 may include a cassette node 904 (which is a soft cassette assembly system) and a centrifuge node 908 (which is a centrifuge system) that can control or communicate with components of the blood component collection set 500 (and associated hardware or mechanical components that interface with the soft cassette assembly 300) and the centrifuge assembly 400 (and associated hardware or mechanical components associated with the centrifuge assembly). The cassette node 904 and the centrifuge node 908 may communicate wirelessly or via some other electrical or data connection. In some configurations, the cassette node 904 and the centrifuge node 908 may be separate nodes that are two parts of a single node 902. Thus, the cassette node 904 and the centrifuge node 908 may each have the same physical hardware that operates to control different functions. In at least one exemplary embodiment, a single node 902 may include the physical hardware for both the cassette node 904 and the centrifuge node 908, or the cassette node 904 may include physical hardware that is separate from the physical hardware of the centrifuge node 908. An example of a cassette node 904 may be described in connection with FIG. 10, and a centrifuge node 908 may be described in connection with FIG. 11.

[0150] Each of the cassette node 904 and the centrifuge node 908 may communicate with one or more sensors 916, 920, and / or 924. As represented by ellipsis 928, there may be more or fewer sensors than those shown in FIG. 9 . Each of the cassette node 904 and the centrifuge node 908 may communicate directly with each sensor 916-924 or may communicate with several sensors 916-924 via a bus 912. The bus 912 may communicate via any type of communication protocol, such as a universal serial bus (USB), a universal asynchronous receiver / transmitter (UART), or other type of bus system or parallel communication connection. Thus, the bus 912 is shown as optional but as a possible communication platform for communicating with the various sensors 916-924. The sensors 916-924 may be any type of sensor capable of communicating information regarding light, fluid, air presence, color, pressure, etc., as described herein. Some examples of sensors 916-924 may include sensors such as air detection sensor 312, fluid sensor 316, AC ADS 804, pressure sensor 808, line sensor 812, second CPS sensor 816, and / or air detection sensor 284. The functions of these sensors 912-924 are described below.

[0151] The cassette node 904 and the centrifuge node 908 may also communicate with one or more pump drives, such as pump motors 936, 940, and 944 (referred to simply as pumps). As represented by ellipsis 948, there may be more or fewer pumps than shown in FIG. 9. The cassette node 904 and the centrifuge node 908 may communicate with the pumps 936-944 via direct wired or wireless communication or via a bus 932. The bus 932 may be a control area network (CAN) bus, USB, or other type of bus architecture for communicating with the pumps 936-944. The pumps 936-944 may include or be part of at least one of the draw pump 208, return pump 212, and / or AC pump 216, as previously described. The functionality of the pumps 936-944 is described herein.

[0152] 10 in accordance with an embodiment of the present disclosure. Cassette node 904 may include a controller 1004, a memory 1008, a valve controller 1020, and / or one or more of a CAN bus 1016, a UART 1012, or a communication interface for other types of buses. Cassette node 904 may include other hardware, firmware, and / or software not shown for clarity.

[0153] The controller 1004 (also referred to herein as a processor) may be any type of microcontroller, microprocessor, field programmable gate array (FPGA), application-specific integrated circuit (ASIC), etc. One example of the controller 1004 is the NK10DN512VOK10 microcontroller manufactured and sold by N9P USA, Incorporated, which is a microcontroller unit with a 32-bit architecture. Other types of controllers are also contemplated. The controller 1004 may control or direct the function of other types of devices, such as valves such as the first fluid control valve 320A, the second fluid control valve 320B, the draw fluid control valve 320C, the plasma flow control valve 286, the saline flow control valve 288, and the pumps 936-944. Additionally, the controller 1004 may communicate with various sensors 916-924 or other devices to receive or send information regarding the function of the apheresis system 200.

[0154] Other examples of processors or microcontrollers 1004 as described herein are the Qualcomm® Snapdragon® 800 and 801, Qualcomm® Snapdragon® 610 and 615 with 4G LTE Integration and 64-bit computing, Apple® A7 processor with 64-bit architecture, Apple® M7 motion coprocessor, Samsung® Exynos® series, Intel® Core™ processor family, Intel® Xeon® processor family, Intel® Atom™ processor family, Intel Itanium® processor family, Intel® Core® i5-4670K and i7-4770K 22nm Haswell, Intel® Core® i5-3570K 22nm The processors may include, but are not limited to, at least one of IvyBridge, AMD® FX™ processor family, AMD® FX-4300, FX-6300, and FX-8350 32nm Vishera, AMD® Kaveri processors, ARM® Cortex™-M processors, ARM® Cortex-A and ARM926EJ-S™ processors, and other industry equivalent processors, and may perform computer functions using any known or future-developed standard instruction set, library, and / or architecture.

[0155] Memory 1008 may be any type of memory including random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), portable compact disc read-only memory (CD-ROM), optical storage, magnetic storage, any suitable combination of these, or any other type of storage or memory device that stores and provides instructions for programming and controlling controller 1004. Memory 1008 may provide any type of software or firmware that programs the functions of controller 1004, as described below.

[0156] The controller 1004 can be in communication with one or more valve controllers 1020. Each valve, such as first fluid control valve 320A, second fluid control valve 320B, draw fluid control valve 320C, plasma flow control valve 286, saline flow control valve 288, etc., as described herein, can be controlled by a valve controller 1020 and associated with components of system 200, as described herein. Valve controller 1020 can provide electrical signals, operating instructions, or power to close or open any one of the valves described herein, such as saline-plasma valve housing 276, plasma flow control valve 286, saline flow control valve 288, first fluid control valve 320A, second fluid control valve 320B, and / or draw fluid control valve 320C.

[0157] The controller 1004 may also be connected to the buses 912, 932 (e.g., UART bus, CAN bus) or other buses via transceivers 1012, 1016 that may be external to the controller 1004 or integral to the controller 1004. The UART transceiver 1012 may communicate with one or more of the sensors 916-924 or other devices. Similarly, the CAN bus transceiver 1016 may communicate with one or more of the pump controllers 936-944 or other devices. The UART transceivers 1012 and buses and the CAN bus transceiver 1016 and buses are well known in the art and need not be described further herein.

[0158] One embodiment of a centrifuge node 908, according to an embodiment of the present disclosure, is shown in FIG. 11. The centrifuge node 908 may include the same or similar types of components as the cassette node 904. For example, the centrifuge node 908 may include a controller 1104, a UART transceiver 1112, etc. Like the controller 1004, the controller 1104 may be any type of processor or microcontroller, such as the previously mentioned NK10DN512VOK10 microcontroller unit with a 32-bit architecture offered by N9P USA, Incorporated, or other controllers, processors, etc. (e.g., devices previously mentioned).

[0159] The controller 1104 can communicate with the sensors 916-924 directly via a UART transceiver 1112 or via other buses or systems. The controller 1104 can also communicate with a brake controller 1124 that can brake or slow down and stop the centrifuge 400. Similarly, the controller 1104 can communicate with a motor transceiver 1116, which communicates with a motor power system or motor controller that functions to spin up or rotate the centrifuge 400 or control the speed setting or other functions of the centrifuge 400.

[0160] In some embodiments, the controller 1104 can also communicate with a cuff controller 1120, which can change or set the pressure in a pressure cuff on the donor's arm during the apheresis process. Additionally, the controller 1104 can communicate with and / or control a strobe light 1114, which, as previously described, can be any light that flashes periodically in synchronization with the rotational speed of a motor so that an operator of the apheresis system 200 can view the operation of the filler 460. Thus, the controller 1104 can communicate with the strobe light 1114 to change the frequency at which the strobe light 1114 flashes, the intensity of the strobe light 1114, etc.

[0161] As will be appreciated, the cassette node 904 and the centrifuge node 908 include other components as described in U.S. Patent Application No. 17 / 392,804, entitled "Method and System for High Throughput Blood Component Collection," filed August 3, 2021, and having attorney docket number 18955-000019-US, the entirety of which is expressly incorporated herein by reference.

[0162] Examples of code scanning and data control methods In at least one exemplary embodiment, a data entry process, such as that illustrated in FIG. 12A, is used to initialize the apheresis system 200 for each new donor 102. The data entry process ensures that a target amount or volume of plasma based on donor weight or other donor information is obtained. Information such as bottle identification is also entered through the data entry process so that the apheresis system can record in memory information about which bottles were used for which donors.

[0163] In at least one exemplary embodiment, the process of FIG. 12A begins at 1200, where the apheresis system 200 is powered on and awaits a new donor. The apheresis system 200 may include an integrated identification reader (e.g., RFID reader, barcode reader, etc.) 1221, as shown in FIG. 12B. The identification reader 1221 is configured to read a code (e.g., RFID tag, barcode, etc.) associated with a particular donor 102 and control the operation of the apheresis system 200 based on the information read by the identification reader. The information may include, but is not limited to, individual donor data (e.g., body mass index (BMI), first-time donor, weight, height, etc.). This information may be used to perform faster and higher-quality donor donations. The code may also be used to label other equipment used during the donation process, such as label 1227 on a bottle 1224 used for plasma collection, as shown in FIG. 12C.

[0164] In 1203, a reader 1221 of the apheresis system 200 is used to scan a barcode, QR code, or other type of image to receive data associated with the donor. In at least one exemplary embodiment, the reader 1221 may be configured to read input from an RFID. For example, a donor may use an ID card or other type of object that includes one or more of a barcode, QR code, RFID, etc. By scanning the ID card or other type of object, the apheresis system 200 can receive data about the donor.

[0165] Barcodes (e.g., one-dimensional, two-dimensional, etc.) are read by an integrated barcode scanner located on the front of the apheresis system. For example, when initiating an apheresis procedure, a user sequentially scans the donor ID (e.g., from a PDA, phone, tablet, etc.), blood component collection set (e.g., separation set), and / or plasma collection bottle. No further input from the user via a user interface is required. The system receives the information and can automatically confirm the data entry without human input. As will be appreciated, this automatic, sequential capture of data increases the speed of operation compared to traditional, non-sequential entry.

[0166] The data received from the donor may include biological information such as age, weight, height, donor history, or other information that may be relevant to the donation process. The data received from the donor is used to determine whether the donor is eligible for the donation procedure and to determine specific settings required for the donation procedure, such as the total expected volume of plasma or other information. For example, the donor's height and weight can be used to determine the donor's body mass. The donor's body mass can then be used to determine a target amount or volume of plasma to be collected.

[0167] In at least one exemplary embodiment, the information may be portable between donation sites, apheresis systems 200, locations, etc. The information may be stored in the form of a nomogram, for example, a two-dimensional barcode. In this way, donors can have a single form of identification between donation sites, and each donation site can collect information about the donor, such as the time since their last visit.

[0168] The information stored in the nomogram and readable by the integrated identification reader is limited to the information that apheresis system 200 is permitted to collect (e.g., by privacy laws, health laws, etc.). In at least one exemplary embodiment, other private information may be stored in the two-dimensional barcode, but may be encrypted or otherwise locked from being read by the integrated identification reader of apheresis system 200.

[0169] The apheresis system 200 scans or reads the barcode and then determines which action to perform. For example, the barcode may include information regarding the weight and height of the donor 102. This may be used to define the amount or volume of plasma the donor 102 can donate. As can be appreciated, a donor 102 of a first weight may be able to donate a first amount of plasma, while a donor 102 of a second, heavier weight may be able to donate a second, greater amount of plasma. Additionally, the body mass of the donor 102 may also be used to define the amount or volume of plasma the donor 102 can donate. Once the apheresis system 200 reads the barcode, the apheresis system 200 may adjust settings based on the information and stop operation when the required amount of plasma, etc., has been collected.

[0170] Apheresis system 200 may also be enabled to write information that can be read by other apheresis systems at the same or other donation sites. For example, donor data may be stored at a network location. Apheresis system 200 may be enabled to transmit data such as donation results, the donor's current weight, the date and / or time of donation, or other information.

[0171] In at least one exemplary embodiment, apheresis system 200 can include one or more computer systems. For example, as described in more detail below with respect to FIG. 16D , apheresis system 200 can include one or more computer systems 1627 that include a processor 1630, memory 1633, input / output devices 1636, one or more pump control systems 1639, one or more sensors 1642, and / or other elements as can be understood.

[0172] In at least one exemplary embodiment, apheresis system 200 is enabled to communicate with a server 1621 via a network 1618, such as the Internet, as described in more detail below with respect to Figure 16B. In at least one exemplary embodiment, apheresis system 200 may communicate with a local computer system, such as a computer located at a blood donation site, configured to communicate with the server.

[0173] In at least one exemplary embodiment, after receiving the data associated with the donor, apheresis system 200 may confirm receipt of the data associated with the donor via a feedback system, such as a graphical user interface (GUI) 1230, as shown in Figures 12B and 12D. In this manner, a nurse, physician, or other user of apheresis system 200 may quickly confirm whether the donor information was properly entered into apheresis system 200. In at least one exemplary embodiment, the feedback system may also, or alternatively, include a speaker configured to provide audio feedback.

[0174] At 1206, the apheresis system 200 determines the donor's identity based on the data associated with the donor. For example, the apheresis system 200 is configured to use the data received via the scanner 1221 to identify whether the donor is associated with donor ID information in a database or whether the donor is a new donor. In at least one exemplary embodiment, the scanner 1221 may access donor information from a server or other computer system locally or via a network connection.

[0175] The donor identification information accessed via the database may include information such as age, body mass, weight, height, and / or target volume, i.e., the expected amount of plasma or other donated fluid to be received from the donor.

[0176] At 1209, apheresis system 200 receives data associated with a blood component collection set. The blood component collection set may comprise, for example, a soft cassette assembly, such as soft cassette assembly 300, used during the blood donation process. Data associated with the blood component collection set may be received by apheresis system 200 via a barcode, QR code, RFID chip, or other type of scannable object placed on the blood component collection set. For example, each blood component collection set may be affixed with a label or sticker that includes a unique barcode, QR code, RFID chip, or other type of scannable object. Scanning the label or sticker on the blood component collection set allows apheresis system 200 to record in memory which blood component collection set is being used for the current donation process. In this manner, apheresis system 200 is able to associate the donor with the blood component collection set. Any data received during the scanning process may be recorded in memory and shared with a server or other type of computing system.

[0177] Data associated with the blood component collection set may include the date of manufacture, the identity of the manufacturer, and other information that may be useful for data processing purposes after the donation is completed. In at least one exemplary embodiment, the data associated with the blood component collection set received through the scan is used to determine the type of blood component collection set. The type of blood component collection set may be used by the apheresis system to adjust one or more settings, such as flow rate or other information, during the donation process.

[0178] In at least one exemplary embodiment, after scanning the blood component collection set, a user of the apheresis system 200 can receive confirmation of receipt of information from the blood component collection set. For example, a graphical user interface 1230, such as that shown in FIG. 12D , displays information regarding whether data from the blood component collection set has been received. Such a graphical user interface 1230 can be used by an operator of the apheresis system in the process of initializing the apheresis system for a new donor. In at least one exemplary embodiment, instead of or in addition to displaying through a graphical user interface, the apheresis system may play a sound through one or more speakers or display lights of various colors to indicate that data has been received.

[0179] At 1212, the method uses apheresis system 200 to receive data associated with a plasma collection bottle. For example, a plasma collection bottle is required to initialize apheresis system 200 for a new donor. After collection, the plasma collection bottle is filled with collected plasma. For data tracking purposes, the plasma collection bottle needs to be associated with the donor. For example, information linking the donor to the plasma collection bottle is stored in memory. For this reason, the unique identification of the plasma collection bottle needs to be recorded. Thus, a user of apheresis system 200 can use apheresis system 200 to scan a label, sticker, or other item printed on or on the plasma collection bottle. For example, as shown in FIG. 12C , a sticker or label 1227 may be affixed to plasma collection bottle 1224. In some exemplary embodiments, sticker or label 1227 includes a QR code.

[0180] As with the other steps, upon receiving data from the plasma collection bottle, the apheresis system 200 may confirm receipt of the data via a graphical user interface, speaker, white, or other feedback system.

[0181] At 1215, the apheresis system performs a plasma collection process based on the information received in the above steps. For example, the apheresis system 200 performs the plasma collection process using information regarding the donor's identity. Data received from the plasma collection bottle and / or blood components may also be used during the plasma collection process.

[0182] For example, the flow rate during the plasma collection process is controlled based on one or more of the donor's body mass and weight determined based on the received data associated with the donor, and the volume of plasma collected is also controlled based on one or more of the donor's body mass and weight determined based on the received data associated with the donor.

[0183] At 1218, the process ends. At that point, the blood donation process may continue with the extraction of fluid from the completed donor. Data received through the above steps may be recorded in memory and / or shared with one or more computer systems. For example, a database entry is created for that particular blood donation, including information such as the amount or volume of plasma extracted from the donor, the donor's current weight, the time and / or date of the donation, and / or other information.

[0184] At least one exemplary embodiment of the present disclosure includes a method comprising receiving, using an apheresis system, data associated with a donor; determining the identity of the donor based on the data associated with the donor; receiving, using the apheresis system, data associated with a blood component collection set; receiving, using the apheresis system, data associated with a plasma collection bottle; and performing, using the apheresis system, a plasma collection process based on the identity of the donor, the data associated with the blood component collection set, and the data associated with the plasma collection bottle.

[0185] In aspects of the above embodiments, receiving the data associated with the donor includes scanning an image with a scanner. In aspects of the above embodiments, the scanner is disposed in the apheresis system. In aspects of the above embodiments, the image is one of a one-dimensional barcode and a two-dimensional barcode. In aspects of the above embodiments, the image is displayed on a user device. In aspects of the above embodiments, receiving the data associated with the donor includes scanning an RFID tag. In aspects of the above embodiments, after receiving the data associated with the donor, confirming receipt of the data associated with the donor via a feedback system. In aspects of the above embodiments, the feedback system includes one or more of a speaker and a graphical user interface. In aspects of the above embodiments, determining that the donor is a new donor based on the data associated with the donor. In aspects of the above embodiments, determining one or more of the donor's body mass and weight based on the data associated with the donor. In aspects of the above embodiments, receiving the data associated with the blood component collection set includes scanning one or more of an image and an RFID tag attached to the blood component collection set with a scanner. Aspects of the above embodiments include, after receiving the data associated with the blood component collection set, confirming receipt of the data associated with the blood component collection set via a feedback system. In aspects of the above embodiments, the feedback system comprises one or more of a speaker and a graphical user interface. In aspects of the above embodiments, receiving the data associated with the plasma collection bottle comprises scanning, with a scanner, one or more of an image and an RFID tag affixed to the plasma collection bottle. Aspects of the above embodiments include, after receiving the data associated with the plasma collection bottle, confirming receipt of the data associated with the plasma collection bottle via the feedback system. In aspects of the above embodiments, the feedback system comprises one or more of a speaker and a graphical user interface.In aspects of the above embodiments, the flow rate during the plasma collection process is controlled based on one or more of the donor's body mass and weight determined based on received data associated with the donor.

[0186] Examples of calibration, maintenance, and inspection of apheresis systems Apheresis system 200 includes one or more devices, systems, and / or features configured to allow for in-situ calibration of apheresis system 200. For example, apheresis system 200 includes one or more devices, systems, and / or features configured to allow for in-situ calibration of apheresis system 200. Stated another way, apheresis system 200 is calibrated after manufacture and installation at a donor processing site. Conventional systems do not provide a method for in-situ calibration.

[0187] In at least one embodiment, apheresis system 200 is self-calibrating. Apheresis system 200 includes a pump and syringes that utilize pressure supplied by a compressor integrated into apheresis system 200, for example, to set a calibration pressure. In other embodiments, the compressor may not be integrated with apheresis system 200 and may be a separate component. Apheresis system 200 may also include a test port configured to generate a known or calibrated pressure, for example, using a pump and compressor. In at least one exemplary embodiment, the test port is located on the back of apheresis system 200 adjacent to other ports, such as a pressure cuff connection, that can change or set the pressure in a pressure cuff on a donor's arm during the apheresis process, as described above with respect to FIG. 11 . Tubing of a blood component collection loop 520, a calibration tubing set, etc., may be attached to or otherwise interconnected with the test port for testing and / or calibration. When interconnected with the test port, the compressor generates a known calibration pressure, and a pressure sensor within apheresis system 200 can be calibrated based on the pressure detected by the pressure sensor. For example, the known calibration pressure is compared to the detected pressure, and the difference is used to calibrate the pressure sensor. The pressure sensor may be located, for example, at the test port or anywhere within apheresis system 200.

[0188] Calibration may also include checking and / or calibrating a holder, such as the holder 1300 shown in FIG. 13A and / or the bottle tray load cell assembly shown in FIGS. 15A-15C, using a calibration object having a known weight (e.g., a NIST weight, etc.). This is described in more detail below. In at least one exemplary embodiment, the holder 1300 may be configured to receive a plasma collection bottle 122. The holder 1300 may be disposed on the top cover 210 of the housing 204 and may be similar to the plasma collection cradle 232C, as shown in FIG. 14A. The holder 1300 may include a weight sensor configured to detect the weight of an object placed on the holder 1300. Thus, during calibration, a calibration object is placed on the holder 1300, and the weight sensor can detect the weight of the calibration object. A difference between the known weight of the calibration object and the detected weight detected by the weight sensor indicates that the weight sensor requires calibration (which may be automatically triggered by the difference) or service. In at least one exemplary embodiment, if the difference is greater than a predetermined threshold, the apheresis system 200 automatically initiates a calibration of the weight sensor. In other embodiments, if the difference is greater than a predetermined threshold, a notification may be provided to alert the user to calibrate the weight sensor.

[0189] Calibration tests and / or calibrations may be performed when one or more components are replaced or replaced in apheresis system 200. For example, replacing or replacing one or more pumps (e.g., pumps 208, 212, 216) may trigger a calibration test. If one or more components of apheresis system 200 fail a calibration test, a calibration (whether of pressure, sensors, weight, etc.) may be performed automatically. If one or more components are not successfully calibrated, apheresis system 200 is locked and cannot be used until each component passes its respective calibration test.

[0190] Method 1302 for performing calibration tests and calibrations, as illustrated by the flowchart in FIG. 13B, begins at 1304. At the start of method 1302, one or more calibration tests are performed or executed. A calibration test may be initiated automatically upon replacement or exchange of one or more components of an apheresis system, such as apheresis system 200 (e.g., one or more sleds, sensors, pumps, etc.). In other exemplary embodiments, a calibration test may be initiated by user input. In yet other exemplary embodiments, a calibration test may be performed prior to use of apheresis system 200.

[0191] At 1306, one or more components of the system (e.g., calibration tubing, sensors, pumps, etc.) are automatically calibrated. Calibration may be initiated, for example, by failure of at least one of the one or more tests performed in step 1304. In other exemplary embodiments, calibration may be initiated by user input. Calibration may be performed using one or more calibration tools, such as, for example, a pump, a test port, a calibration object, etc. When calibration is performed, a user may be prompted via a user interface, such as a graphical user interface (GUI), to connect one or more calibration tools or components to perform the calibration.

[0192] It will be appreciated that steps 1304 and 1306 may be repeated (separately or together). For example, a component may fail a calibration test in step 1304, the component may be automatically calibrated in step 1306, and the component may be tested again in step 1304 to test whether the component was properly calibrated.

[0193] The apheresis system 200 may also include one or more protocols for checking the equipment. These protocols may include calibration (described above), automated tests (e.g., limit and full-range tests), fluid runs (with actual parameters), etc. In at least one exemplary embodiment, a saline check is performed. In such an embodiment, the apheresis system 200 may include a weight sensor configured to sense the weight of the plasma collection bottle 122. Saline is transferred from the saline bag 118 to the plasma collection bottle 122, and a change in weight of the plasma collection bottle 122 is detected by the weight sensor. Such a weight change indicates that saline is properly flowing from the saline bag 118 through the saline tubing 116 to the plasma collection bottle 122. In at least one exemplary embodiment, a disposable test is performed to check the blood component collection set 500 for leaks. In such an embodiment, the apheresis system 200 includes a pump configured to create a vacuum within the blood component collection set 500. The apheresis system 200 may also include sensors for detecting such leaks in the blood component collection set 500. In one exemplary embodiment, a centrifuge test is performed to test the centrifuge assembly 400. In such an embodiment, the rotor motor and motor assembly 414 may be activated to verify proper rotation of the centrifuge assembly 400.

[0194] Example of a moving loop holder 14A-14F illustrate a transfer loop holder 1400 as included in apheresis system 200. As shown, the transfer loop holder 1400 may be at least partially disposed within a centrifuge chamber 1402 of apheresis system 200. The centrifuge chamber 1402 is defined as the interior space of apheresis system 200 in which the centrifuge assembly 400 is housed, and is located, for example, behind access panel 224. As shown in FIG. 14B, the transfer loop holder 1400 is disposed above the centrifuge assembly 400 (e.g., spaced apart from the centrifuge assembly 400 in the positive z-axis direction). The transfer loop holder 1400 may correspond to the fixed loop connector 402 or a portion of the fixed loop connector 402 described above.

[0195] The moving loop holder 1400 includes a loop holder body (also referred to as a loop holder) 1408 having a loop connection space (also referred to as a loop connection portion) 1412. A portion of the blood component collection set 500 is held by the loop connection space 1412. For example, as illustrated in FIG. 14C , the loop connection space 1412 may be configured to receive or capture a portion of a flexible loop 524, a system securement loop connector 528, or a combination thereof. In at least one exemplary embodiment, a connector locking wheel 1424 and a flange 1428 function to securely lock the system securement loop connector 528 within the loop connection space 1412. For example, as shown, the system securement loop connector 528 and / or the flexible loop 524 are disposed between the upper connector locking wheel 1424 and the flange 1428, and the upper connector locking wheel 1424 is moved relative to the flange 1428 to apply a holding pressure to the system securement loop connector 528 and / or the flexible loop 524. In at least one exemplary embodiment, the traveling loop holder 1400 allows the flexible loop 524 used in the blood component collection set 500 to be shorter than the distance that would be required without the traveling loop holder 1400. In some variations, the shorter distance can reduce the effective circulating volume of the blood component collection set 500. The shorter distance can reduce waste, for example, in the materials used to manufacture the blood component collection set 500, the blood components remaining in the blood component collection set 500 after use, etc. The shorter distance allows for control of the length of the flexible loop 524 to prevent tangling or snagging and / or to ensure proper fit within the apheresis system 200.

[0196] The traveling loop holder 1400 is movable (using an automated or manual process) between a first state, i.e., an activated or extended state (see, e.g., FIGS. 14A, 14B, and 14D), and a second state, i.e., an attached or retracted state (see, e.g., FIG. 14E). For example, the traveling loop holder 1400 is movable (along the x-axis) from an extended position near the first side or front portion 202 of the apheresis system 200 to or toward the second side or rear portion 206 of the apheresis system 200. In the extended position, the traveling loop holder 1400 is fixedly coupled to the blood component collection loop 520. In the retracted position, the blood component collection loop 520 is detached or disconnected from the loop holder body 1408. For example, the traveling loop holder 1400 includes a release latch 1404. The release latch 1404 is actuated (e.g., pulled, unlatched, etc.) to unlock the moving loop holder 1400 from a first or locked state to a second or unlocked state. In the unlocked state, the loop holder body 1408 is moved in a retraction direction 1420 (e.g., away from the front portion 202 of the apheresis system 200 and / or housing 204 toward the rear portion 206). The retraction direction 1420 is defined along both the x-axis and the z-axis in the XZ plane.

[0197] In at least one exemplary embodiment, as shown in FIG. 14E , for example, retraction of the moving loop holder 1400 provides clearance for pivoting the upper housing 404B from inside the centrifuge chamber 1402 to a position outside the centrifuge chamber 1402 (compare, for example, FIGS. 4D, 4E, and 4F). For example, as the loop holder body 1408 moves in the retraction direction 1420, the loop holder body 1408 is positioned outside the filler pivot locus arc 1410, shown in FIG. 14C as an arcuate centerline pivoting about, for example, the y-axis. A pivot clearance space 1416 is formed between the loop holder body 1408 and the filler pivot locus arc 1410. The pivot clearance space 1416 allows the upper housing 404B to pivot relative to the lower housing 404A (e.g., without the upper housing 404B contacting the loop holder body 1408) when the centrifuge split housing 404 moves from the operational state to the loaded state, or vice versa. For example, when the moving loop holder 1400 is in the retracted position, the upper housing 404B hinges upside down to load, for example, the filler 460 along with the blood component collection loop 520 and blood component collection bladder 536. Once loaded, the upper housing 404B is closed and locked in the operational state. When the upper housing 404B is fixed in an operative state (e.g., the upper housing 404B and the lower housing 404A are connected), the moving loop holder 1400 is extended (e.g., moved to an extended state), for example, to hold the blood component collection loop 520 in a fixed position relative to the centrifuge assembly 400.

[0198] In at least one exemplary embodiment, when the traveling loop holder 1400 is disposed in the extended state, the loop holder body 1408 is spaced a first distance 1430A from the centrifuge assembly 400, including the upper housing 404B, preventing the upper housing 404B from moving from the operational state to the loaded state and vice versa. For example, when the loop holder body 1408 is spaced the first distance 1430A in the extended state, if the upper housing 404B hinges relative to the lower housing 404A, the upper housing 404B will contact the loop holder body 1408. To move the centrifuge assembly 400 between the operational state and the loaded state, the traveling loop holder 1400 must first be moved to the retracted state 1400B. When the traveling loop holder 1400 is in the retracted state 1400B, for example, as shown in FIG. 14C , the retracted loop holder body 1408′ is spaced a second distance 1430B from the centrifuge assembly 400. The second distance 1430B is greater than the first distance 1430A and defines a pivot clearance space 1416 between the loop holder body 1408 and a filler pivot locus arc 1410. The filler pivot locus arc 1410 corresponds to the path of the outermost portion of the upper housing 404B as it hinges about the split housing pivot axis 406 (e.g., relative to the lower housing 404A, etc.). When the traveling loop holder 1400 is in the retracted state 1400B, the upper housing 404B can hinge relative to the lower housing 404A without contacting the loop holder body 1408.

[0199] In at least one exemplary embodiment, apheresis system 200 cannot operate when traveling loop holder 1400 is in retracted state 1400B. Apheresis system 200 can only operate when traveling loop holder 1400 is in the extended state. For example, apheresis system 200 includes one or more sensors configured to detect the position of traveling loop holder 1400 and, based on the detected position, provide input to a controller of apheresis system 200 that includes information regarding the position of traveling loop holder 1400. In response, the controller restricts operation of apheresis system 200 when traveling loop holder 1400 is in the retracted state and enables operation of apheresis system 200 when traveling loop holder 1400 is in the extended state.

[0200] The blood component collection set 500 is partially loaded into the apheresis system 200 by moving the transfer loop holder 1400 to the retracted state 1400B and hingedly rotating the upper housing 404B to the loaded position (see, e.g., FIGS. 4F and 6A). In at least one exemplary embodiment, when the upper housing 404B is in the open loaded state, at least a portion of the upper housing 404B extends outside the centrifuge chamber 1402. In this "inverted" loaded state, the inverted upper housing 404B provides clearance and access for loading the blood component collection bladder 536 into the filler 460 (e.g., disposed within the upper housing 404B), as described above. Once the blood component collection loop 520 is connected or otherwise coupled to the filler 460, the upper housing 404B is hingedly rotated from the loaded state to the operative state (see, e.g., FIG. 6C). In this position, the transfer loop holder 1400 is moved from the retracted state 1400B to the extended state (see, e.g., FIG. 14C ), and the system-locking loop connector 528 of the blood component collection loop 520 is interconnected with the loop connection space 1412 of the loop holder body 1408. Note that removal of the filler 460 is performed by reversing the order of the above operations. For example, removing the filler 460 and / or the centrifuge assembly 400 involves separating the system-locking loop connector 528 from the loop connection space 1412 and moving the loop holder 1400 from the extended state to the retracted state 1400B. In the retracted state 1400B, the upper housing 404B is rotated or hinged from the operating position to the open, loaded position. In the open position, the blood component collection loop 520 is disconnected and removed from the filler 460. The loading and unloading process is repeated to reload the filler 460 and / or centrifuge assembly 400 after each use or operation of the apheresis system 200.

[0201] In at least one exemplary embodiment, the present disclosure provides an apheresis system. The apheresis system includes a housing having a front portion and a rear portion, a centrifuge chamber disposed within the housing, a centrifuge assembly disposed within the centrifuge chamber, and a mobile loop holder disposed within the centrifuge chamber, the mobile loop holder having a loop holder body and a loop connection space disposed within the loop holder body. The loop connection space may be sized to receive a connector of a flexible loop. The mobile loop holder may be movable between an extended state within the centrifuge chamber and a retracted state within the centrifuge chamber, wherein in the extended state, the loop holder body is spaced a first distance from the centrifuge assembly, and in the retracted state, the loop holder body is spaced a second distance from the centrifuge assembly, the second distance being greater than the first distance. In at least one exemplary embodiment, the centrifuge assembly may include a centrifuge housing, and the centrifuge housing may include a mounted state and an operational state. When the traveling loop holder is in the extended state, the centrifuge housing is prevented from moving from the operating state to the attached state, and when the traveling loop holder is in the retracted state, the centrifuge housing is allowed to move from the operating state to the attached state. In at least one exemplary embodiment, the centrifuge housing has a split housing including a lower housing portion and an upper housing portion, the upper housing portion hingedly pivoting relative to the lower housing portion, the upper housing portion hingedly pivoting along an arc when moving between the operating state and the attached state. In at least one exemplary embodiment, when the traveling loop holder is in the retracted state, a clearance space may be formed between the loop holder body and the arc to provide a movement path along the arc that the upper housing portion follows when hingedly pivoting relative to the lower housing portion between the operating state and the attached state without the loop holder body.In at least one exemplary embodiment, when the mobile loop holder is in the extended state, there is no clearance space between the loop holder body and the arc, preventing the upper housing portion from hingedly pivoting relative to the lower housing portion between the operational state and the attached state. In at least one exemplary embodiment, when the mobile loop holder is in the retracted state, the loop holder body is positioned closer to the rear portion of the housing than when the mobile loop holder is in the extended state. In at least one exemplary embodiment, the loop holder body may include a connector lock that engages with the connector of the flexible loop to lock the flexible loop to the loop holder body and the loop connection space. In at least one exemplary embodiment, the movable loop holder includes a loop holder body and a loop connection space disposed within the loop holder body. The loop connection space is sized to receive a connector of a flexible loop of a blood component collection set. The movable loop holder may be movable between an extended state within a centrifuge chamber of an apheresis system and a retracted state within the centrifuge chamber, wherein in the extended state, the loop holder body is spaced a first distance from a centrifuge assembly disposed within the centrifuge chamber, and in the retracted state, the loop holder body is spaced a second distance from the centrifuge assembly disposed within the centrifuge chamber, the second distance being greater than the first distance. In at least one exemplary embodiment, the loop holder body may include a connector lock that engages with the connector of the flexible loop to lock the flexible loop to the loop holder body and the loop connection space.

[0202] In at least one exemplary embodiment, a method for installing a centrifuge filler for an apheresis system is provided. The method includes providing an apheresis system including a housing having a front portion and a rear portion, a centrifuge chamber disposed within the housing, a centrifuge assembly disposed within the centrifuge chamber, and a moving loop holder disposed within the centrifuge chamber. The centrifuge assembly has a split housing including a lower housing portion and an upper housing portion, the upper housing portion hingedly pivoting relative to the lower housing portion. The centrifuge housing has a mounted state and an operational state. The moving loop holder includes a loop holder body and a loop connection space disposed within the loop holder body. The loop connection space may be sized to receive a connector of a flexible loop. The travelling loop holder may be movable between an extended state within the centrifuge chamber and a retracted state within the centrifuge chamber, wherein in the extended state the loop holder body is positioned a first distance away from the centrifuge assembly and in the retracted state the loop holder body is positioned a second distance away from the centrifuge assembly, the second distance being greater than the first distance. The upper housing portion hinges along an arc when moving between the operational state and the stowed state, such that when the travelling loop holder is in the extended state, the split housing is prevented from moving from the operational state to the stowed state and when the travelling loop holder is in the extended state, the split housing is allowed to move from the operational state to the stowed state.The method for loading a centrifuge filler further includes actuating a release latch to unlock the traveling loop holder from a locked state to an unlocked state, moving the traveling loop holder from the extended state to the retracted state, hingedly rotating the upper housing portion relative to the lower housing portion such that the upper housing portion is at least partially positioned outside the centrifuge chamber and the upper housing portion is in the loaded state with the traveling loop holder in the retracted state, coupling a blood component collection bladder and the flexible loop of a blood component collection set to a filler positioned in the upper housing portion with the upper housing portion in the loaded state, hingedly rotating the upper housing portion relative to the lower housing portion such that the upper housing portion is positioned inside the centrifuge chamber and the upper housing portion is in the operative state when the traveling loop holder is in the retracted state, and moving the traveling loop holder from the retracted state to the extended state and locking the traveling loop holder in the locked state with the release latch.

[0203] Example of a bottle tray with magnetic coupling and load cell overload protection 15A-15M illustrate various views of a load cell assembly and its components, according to at least one exemplary embodiment. FIG. 15A is a perspective view of a load cell assembly, according to at least one exemplary embodiment. FIG. 15B is an exploded perspective view of the load cell assembly of FIG. 15A, according to at least one exemplary embodiment.

[0204] In at least the illustrated exemplary embodiment, the load cell assembly 1500 is a bottle tray load cell assembly. The load cell assembly 1500 has a fixed portion, a flexible portion ( FIG. 15B ), and a load cell 1506. In at least one exemplary embodiment, the fixed portion includes a plate 1508 (also referred to as a “mount plate”) and a bracket 1510 (also referred to as a “load cell support bracket”). In at least one exemplary embodiment, the flexible portion includes a first component 1512 (also referred to as a “load interface plate”), a second component 1514 (also referred to as an “overload support bar”), and a cradle 1516 (also referred to as a “bottle cradle” or “plasma collection cradle”). The load cell assembly 1500 extends along a central or longitudinal axis 1517. In at least one exemplary embodiment, the longitudinal axis 1517 passes through the center of the load cell 1506.

[0205] In at least one exemplary embodiment, the cradle 1516 may be similar to the plasma collection cradle 232C of FIG. 2A. The plasma collection cradle 1516 may be attached to an overload support bar 1514. As described above, the plasma collection cradle 1516 is configured to receive, orient, and / or hold a container, such as a plasma collection bottle (e.g., bottle 1598 of FIG. 15M or container 2716 of FIG. 26J), in an apheresis system, such as the apheresis system 200 shown in FIG. 1. In at least one exemplary embodiment, the load cell 1506 is configured to flex and sense the load and / or weight of the container. The load cell 1506 may be sensitive to forces within a predetermined (or desired) range. For example, if the force applied to the load cell 1506 falls outside of (e.g., exceeds) the predetermined range, the accuracy of the load measurement and / or the integrity of the load cell 1506 may be compromised.

[0206] In at least one exemplary embodiment, the cradle 1516 is coupled to the load cell 1506 via a magnetic coupling and interface. The magnetic coupling may be configured to mechanically decouple the cradle 1516 from the load cell 1506, thereby reducing or preventing mechanical forces from being continuously applied to the deflecting beam portion and / or the load cell 1506. In at least one exemplary embodiment, as described in more detail below, upon reaching a predetermined load amount, the cradle 1516 breaks the magnetic interconnection force, causing the cradle 1516, plate 1508, and second component 1514 to separate from the apheresis system 200. Among other things, this magnetic interconnection can reduce or prevent damage to the load cell 1506, sensing components, support elements, deflecting beam portions, and / or other mechanical elements disposed between the cradle 1516 and the load cell 1506.

[0207] In at least one exemplary embodiment, the first component 1512 includes a first magnet 1518 and the second component 1514 includes a second magnet 1520. The first magnet 1518 may be coupled to the first component 1512 by a first fastener 1522A. The second magnet 1520 may be coupled to the second component 1514 by a second fastener 1522B. As described in more detail below, the load cell 1506 may be coupled to the bracket 1510 by one or more third fasteners 1522C. The first component 1512 may be coupled to the load cell 1506 by one or more fourth fasteners 1522D. The mounting plate 1508 may be coupled to the bracket 1510 by one or more fifth fasteners 1522E. The second component 1514 may be coupled to the cradle 1516 by one or more sixth fasteners 1522F. In at least one exemplary embodiment, the fasteners 1522A, 1522B, 1522C, 1522D, 1522E, 1522F may be independently selected from flat head screws, hex socket bolts, hex screws, bolts, and the like.

[0208] 15C and 15D are top and bottom perspective views of a mounting plate of the load cell assembly of FIG. 15A and FIG. 15C, respectively, according to at least one exemplary embodiment.

[0209] 15C and 15D, the mount plate 1508 includes a generally flat, planar body 1524 having a first side 1526A and a second side 1526B. The planar body 1524 may define a generally rectangular perimeter (e.g., a rectangle with rounded corners).

[0210] In at least one exemplary embodiment, planar body 1524 has one or more first openings 1528 (e.g., four openings 1528 as shown). Fasteners (not shown) can extend through first openings 1528 to couple load cell assembly 1500 (shown in FIGS. 15A and 15B ) to apheresis system 200 (shown in FIG. 1 ) via mounting plate 1508. In at least one exemplary embodiment, bottle tray load cell assembly 1500 can be completely removed from apheresis system 200 by removing the fasteners. Among other things, this feature allows for rapid replacement and / or maintenance of bottle tray load cell assembly 1500 and / or components of bottle tray load cell assembly 1500, as described in further detail below in the description regarding FIG. 18A .

[0211] In at least one exemplary embodiment, a first flange 1530 extends from the planar body 1524 on the first side 1526A. The first flange 1530 may be rectangular in shape. In at least one exemplary embodiment, the mount plate 1508 includes a gasket 1532 (shown in FIG. 15D ) on the first side 1526A. The gasket 1532 may be adjacent to the first flange 1530. When the load cell assembly 1500 (shown in FIGS. 15A and 15B ) is coupled to the apheresis system 200 (shown in FIG. 1 ), the gasket 1532 is between the planar body 1524 of the plate 1508 and the housing 204 (shown in FIG. 2A ). In at least one exemplary embodiment, the gasket 1532 may be or include an O-ring, a flat seal gasket, or other flexible seal member. Additionally or alternatively, gasket 1532 may be or include an electromagnetic shielding gasket (EMI gasket) (eg, a metal gasket, a spring, a metalized gasket, etc.).

[0212] In at least one exemplary embodiment, the planar body 1524 has a second opening 1534 formed therein. The second opening 1534 may be a central opening. In at least one exemplary embodiment, a second flange 1536 may extend from a second side 1526B of the planar body 1524. The second flange 1536 may be a circular flange. The second flange 1536 extends around the second opening 1534. In at least one exemplary embodiment, a portion of the second component 1514 (shown in FIGS. 15A and 15B) extends through the second opening 1534. The second component 1514 is configured to translate along the longitudinal axis 1517 when a flexure portion (shown in FIGS. 15A, 15B) of the load cell assembly 1500 flexes. In at least one exemplary embodiment, the amount of deflection is very small, such as about 0.05 inches or less (eg, about 0.01 inches or less, or about 0.005 inches or less).

[0213] FIG. 15E is a perspective view of a bracket of the load cell assembly of FIG. 15A, according to one exemplary embodiment.

[0214] 15E, the bracket 1510 has a wall 1538 and a third flange 1540. The third flange 1540 includes a first flange portion 1540A and a second flange portion 1540B. The first and second flange portions 1540A, 1540B can be spaced apart from one another. The first and second flange portions 1540A, 1540B include upper surfaces 1541A, 1541B, respectively. The upper surfaces 1541A, 1541B can be coplanar.

[0215] In at least one exemplary embodiment, wall 1538 defines a receptacle 1542. Receptacle 1542 is generally rectangular in shape. Receptacle 1542 can receive at least a portion of load interface plate 1512 and / or at least a portion of overload support bar 1514, as shown in FIG. 15I.

[0216] The wall 1538 may further include a recess 1543 formed therein. The recess 1543 may have a semi-cylindrical shape. The recess 1543 may extend between the receptacle 1542 and an upper surface 1544 of the wall 1538. As shown in FIG. 15I, the recess may receive at least a portion of the overload support bar 1514.

[0217] In at least one exemplary embodiment, the bracket 1510 further includes a gusset plate 1546 extending between the wall 1538 and the third flange 1540. In at least one exemplary embodiment, the wall 1538, the third flange 1540, and the gusset plate 1546 may cooperate to define an inner bracket area 1547. As described in more detail below, in at least one exemplary embodiment, portions of the load cell 1506, the first component 1512, and the second component 1514 may reside within the inner bracket area 1547. Thus, when mounting plate 1508 is attached to housing 204 of apheresis system 200 (shown in FIG. 2A), bracket 1510 is inside a guarded portion of apheresis system 200 (e.g., protecting load cell 1506 and / or other components of load cell assembly 1500 from damage, tampering, and / or the environment outside apheresis system 200, etc.).

[0218] In at least one exemplary embodiment, the bracket 1510 is attached to the mounting plate 1508. In the illustrated exemplary embodiment, the bracket 1510 is attached to a first side 1526A of the mounting plate 1508. One or more third apertures 1550 are formed in an upper surface 1544 of the wall 1538 of the bracket 1510. A fifth fastener 1522E extends through the third aperture 1550 and the plate 1508 to couple the bracket 1510 to the mounting plate 1508. One or more fourth apertures 1551 may be formed in the second flange portion 1540B. In at least the illustrated exemplary embodiment, a third fastener 1522C can pass through the fourth aperture 1551 to couple the load cell 1506 (shown in FIGS. 15A and 15B ) to the bracket 1510, as described in more detail below.

[0219] FIG. 15F is a perspective view of a load cell of the load cell assembly of FIG. 15A, according to one exemplary embodiment.

[0220] 15F, the load cell 1506 includes a fixed end 1552 (or fixed side) and a free end 1554 (or free side or load deflection side). As shown in FIG. 15A, the fixed end 1552 is fixed to the bracket 1510. Specifically, the fixed end 1552 of the load cell 1506 contacts the second flange portion 1540B. In at least one exemplary embodiment, the fixed end 1552 of the load cell 1506 may be in direct contact with the second flange portion 1540B. The load cell 1506 may be at least partially within an inner bracket region 1547 of the bracket 1510.

[0221] In at least one exemplary embodiment, the free end 1554 of the load cell 1506 is spaced from at least a portion of the bracket 1510, such as the first flange portion 1540A, to define a flexure region 1556 (also shown in FIGS. 15A and 15I ). The free end 1554 of the load cell 1506 is configured to move within the flexure region 1556 in response to the application of a force or load in a first direction 1558. The first direction 1558 is generally parallel to the central axis 1517.

[0222] In at least one exemplary embodiment, the load cell 1506 is a deflection-based load cell. As the free end 1554 moves or translates relative to the fixed end 1552, the load cell 1506 can determine a force, weight, or load associated with the measured deflection. The load cell 1506 can be subjected to forces perpendicular to the flexible member of the load cell 1506 (e.g., in a first direction 1558), although the load cell 1506 may also be sensitive to subjected rotational, torsional, or parallel forces. Examples of the load cell 1506 include, but are not limited to, a shear beam load cell, an S-beam load cell, a single-point load cell, a dual shear beam load cell, a bending beam load cell, a canister load cell, a strain gauge, a bending-type load cell, and / or combinations thereof.

[0223] 15A and 15B , in at least one exemplary embodiment, the load cell assembly 1500 includes a magnetic coupling between a load interface plate 1512 and an overload support bar 1514. In at least the illustrated exemplary embodiment, the load interface plate 1512 includes a first magnet 1518, and the overload support bar 1514 includes a second magnet 1520. The magnets 1518, 1520 may be positioned such that opposite poles face each other when the overload support bar 1514 is engaged with the load interface plate 1512, as shown in FIG. 15I . With this arrangement, the magnetic force between the magnets 1518, 1520 maintains the overload support bar 1514 engaged with the load interface plate 1512.

[0224] FIG. 15G is a perspective view of a load interface plate of the load cell assembly of FIG. 15A according to at least one exemplary embodiment.

[0225] In at least one exemplary embodiment, as shown in FIG. 15G, the load interface plate 1512 includes an interface body or first cam body 1560 and an extension or mount 1562. The load interface plate 1512 has a first side or load cell side 1564A and a second side or interface side 1564B. The first cam body 1560 has a first recess or indentation 1566 formed therein. When the load cell assembly 1500 (shown in FIG. 15A) is assembled, the load interface axis 1517A is aligned with the central axis 1517 (shown in FIG. 15A). The first magnet 1518 may reside at least partially within the first recess 1566. The load interface axis 1517A extends through the center of the first recess 1566. A first magnet 1518 (shown in FIG. 15B) may be glued, pinned, crimped, or otherwise secured within the first recess 1566. In at least the illustrated exemplary embodiment, the first magnet 1518 may be attached to the overload support bar 1514 via a first fastener 1522A, such as a flat head screw. In at least one exemplary embodiment, a surface of the first magnet 1518 may be positioned flush with or below a first cam surface 1567 of the overload support bar 1514.

[0226] In at least one exemplary embodiment, the first cam surface 1567 defines a plurality of valleys 1568. In at least the illustrated exemplary embodiment, the plurality of valleys 1568 includes a first valley 1568A, a second valley 1568B, and a third valley 1568C. The valleys 1568 may be asymmetrically disposed about the load interface axis 1517A (e.g., centers spaced approximately 90 degrees apart from one another). In at least one exemplary embodiment, each of the valleys 1568 is configured as a dwell or recess having at least one beveled, chamfered, or tapered side.

[0227] In at least one exemplary embodiment, first cam surface 1677 may further define a first flat portion 1569. In the illustrated exemplary embodiment, first flat portion 1569 is between first valley 1568A and third valley 1568C. First flat portion 1569 may extend uninterrupted between first valley 1568A and third valley 1568C. Valleys 1568A, 1568B, 1568C and first flat portion 1569 are circumferentially disposed about first recess 1566.

[0228] In at least one exemplary embodiment, the second side 1564B of the first cam body 1560 may further include a plurality of notches 1570 formed therein. Each of the plurality of notches 1570 corresponds to a respective one of the valleys 1568. The notches 1570 may be centered within each of the respective valleys 1568.

[0229] The extension 1562 is adjacent to the first cam body 1560. At least in the illustrated exemplary embodiment, the extension 1562 has a generally rectangular cross-section. The extension 1562 may have one or more fourth openings 1571 formed therein. The fourth openings 1571 may receive fourth fasteners 1522D to couple the load interface plate 1512 to the load cell 1506 (shown in FIG. 15B).

[0230] FIG. 15H is a perspective view of an overload support bar of the load cell assembly of FIG. 15A according to at least one exemplary embodiment.

[0231] 15H, in at least one exemplary embodiment, the overload support bar 1514 includes a mandrel 1572 that extends lengthwise from a first end 1573A to a second end 1573B along a longitudinal or support bar axis 1517B (e.g., coincident with axis 1517 in FIG. 15A). In at least one exemplary embodiment, the overload support bar 1514 includes a second cam body 1574 at the first end 1573A and a coupling portion 1575 at the second end 1573B.

[0232] In at least one exemplary embodiment, the coupling portion 1575 has a diameter larger than the diameter of the mandrel 1572. The coupling portion 1575 has a receptacle formed therein, such as a fifth opening 1575A, which can cooperate with a sixth fastener 1522F to couple the cradle 1516 (shown in FIG. 15A ) to the overload support bar 1514.

[0233] In at least one exemplary embodiment, the second cam body 1574 is generally cylindrical. The second cam body 1574 has a second recess or indentation 1576 formed therein. The support bar axis 1517B extends through the center of the second recess 1576. When the load cell assembly 1500 (shown in FIG. 15A ) is assembled, the support bar axis 1517B is aligned with the central axis 1517. The second magnet 1520 may reside at least partially within the second recess 1576. The second magnet 1520 (shown in FIG. 15B ) may be glued, pinned, crimped, or otherwise secured within the second recess 1576. In at least the illustrated exemplary embodiment, the second magnet 1520 may be attached to the overload support bar 1514 via a second fastener 1522B, such as a flat head screw. In at least one exemplary embodiment, the surface of the second magnet 1520 may be positioned flush with or below the second cam surface 1577 of the overload support bar 1514 .

[0234] In at least one exemplary embodiment, the second cam surface 1577 is formed with a plurality of lobes 1578. In at least the illustrated exemplary embodiment, the plurality of lobes 1578 includes a first lobe 1578A, a second lobe 1578B, and a third lobe 1578C. The lobes 1578 may be asymmetrically positioned about the support bar axis 1517B (e.g., centers spaced approximately 90 degrees apart from one another). In at least one exemplary embodiment, each of the lobes 1578 is configured as a protrusion having at least one angled or tapered side extending from the tip of the protrusion.

[0235] In at least one exemplary embodiment, the second cam surface 1577 of the second cam body 1574 may further include a second flat portion 1579 formed thereon. In the illustrated exemplary embodiment, the second flat portion 1579 is between the first lobe portion 1578A and the third lobe portion 1578C. The second flat portion 1579 may extend uninterrupted between the first lobe portion 1578A and the third lobe portion 1578C. The lobe portions 1578A and the second flat portion 1579 are circumferentially disposed about the second recess 1576.

[0236] In at least one exemplary embodiment, an advantage of the asymmetrical arrangement of lobes 1578 and valleys 1568 (shown in FIG. 15G) is that the overload support bar 1514 can only engage with the load interface plate 1512 in one orientation (e.g., to prevent improper loading of the plasma collection cradle 1516 into the apheresis system 200). In at least one exemplary embodiment, among other things, this asymmetrical arrangement ensures that the plasma collection cradle 1516 is always mounted in approximately the same orientation on the apheresis system 200.

[0237] 15G-15H , in at least one exemplary embodiment, the arrangement of valleys 1568 ( FIG. 15G ) provides at least one mating surface at each location of valley 1568 configured to contact a corresponding surface of lobe 1578 ( FIG. 15H ). When overload support bar 1514 is engaged with load interface plate 1512 (e.g., in an engaged state), first cam lobe 1578A aligns with and fits within first valley 1568A, second lobe 1578B aligns with and fits within second valley 1568B, and third lobe 1578C aligns with and fits within third valley 1568C. In at least one exemplary embodiment, first cam surface 1567 may be in continuous, uninterrupted contact with second cam surface 1577.

[0238] In at least one exemplary embodiment, when the overload support bar 1514 is tilted, twisted, or rotated relative to the load interface plate 1512 (e.g., via an external force applied to the plasma collection cradle 1516 shown in FIG. 15A and / or a plasma collection bottle within the plasma collection cradle 1516, etc.), at least a portion of the second cam surface 1577 disengages from (e.g., does not directly contact) the first cam surface 1567. In at least this exemplary embodiment, as the overload support bar 1514 rotates about axis 1517B, one or more of the plurality of lobes 1578 contact the first flat portion 1569 of the load interface plate 1512.

[0239] 15I and 15J are partial cross-sectional views of the load cell assembly of FIG. 15A in an engaged state and a disengaged state with a portion of the first magnet cut away, according to at least one exemplary embodiment.

[0240] 15I-15J, each of the magnets 1518, 1520 has a first pole side 1580A (e.g., a north pole) and a second pole side 1580B (e.g., a south pole). The first pole side 1580A has a first polarity, and the second pole side 1580B has a second polarity opposite the first polarity. The magnets 1518, 1520 are positioned such that their opposite poles (i.e., poles with opposite polarities) face each other. In the illustrated exemplary embodiment, the first magnet 1518 is located within the first recess 1566 of the load interface plate 1512 such that the first pole side 1580A of the first magnet 1518 faces the overload support bar 1514. The second magnet 1520 is within the second recess 1576 of the overload support bar 1514 such that the second pole side 1580B of the second magnet 1520 faces the load interface plate 1512. In at least one other exemplary embodiment, the load cell assembly includes a single magnet disposed on the load interface plate or the overload support bar, with a magnetically attracting metal (e.g., iron, steel, etc.) disposed on the other of the load interface plate or the overload support bar.

[0241] The bottle tray load cell assembly 1500 can provide overload protection for the load cell 1506 and / or other components by the overload support bar 1514 moving from an engaged state shown in FIG. 15I to a disengaged state shown in FIG. 15J when a predetermined movement and / or force is received by the overload support bar 1514. The movement and / or force corresponds to a rotation about a central axis 1517 in a rotational direction 1582, a moment about the axis 1517, a moment about the y-axis shown, a moment about the x-axis shown, and / or combinations thereof. Among other things, the ability to disengage the overload support bar 1514 from the load interface plate 1512 prevents non-linear forces (e.g., forces that do not act solely along the z-axis, which indicates the direction of gravity) from damaging the load cell 1506 and / or components of the bottle tray load cell assembly 1500.

[0242] 15J , when subjected to a force in a first rotational direction 1582A, the overload support bar 1514 rotates counterclockwise relative to the load interface plate 1512. This force, caused by an accidental bump and / or accidental rotation of the cradle 1516, causes the overload support bar 1514 to rotate about axis 1517. As the overload support bar 1514 rotates, the lobes 1578 move along the sloped or tapered sides of the valleys 1568, causing the overload support bar 1514 to move upward relative to the load interface plate 1512, resulting in the overload support bar 1514 being at least partially spaced apart from the load interface plate 1512. In at least one exemplary embodiment, when fully disengaged, the overload support bar 1514 is separated from the load interface plate 1512 by a separation distance 1583. In this position, the lobes 1578 contact the first flat portion 1569 of the load interface plate 1512 and are disengaged or out of alignment with the valleys 1568 .

[0243] When the overload support bar 1514 separates from the load interface plate 1512, a separation space 1584 is formed between the overload support bar 1514 and the load interface plate 1512. This separation space 1584 can provide sufficient clearance between the first and second magnets 1518, 1520 so that continued rotational forces applied to the overload support bar 1514 do not exert certain forces (e.g., twisting, rotation, and / or moment) on the load interface plate 1512. In at least one exemplary embodiment, the magnetic force between the magnets 1518, 1520 when in a disengaged state (e.g., due in part to the separation distance 1583) is less than the magnetic force between the magnets 1518, 1520 when in an engaged state (shown in FIG. 15I). Thus, the load cell 1506 is protected from continued rotational or moment forces. To reset the bottle tray load cell assembly 1500, rotate the overload support bar 1514 until the lobes 1578 align with the valleys 1568 and the overload support bar 1514 moves toward the load interface plate 1512 and the separation distance 1583 decreases and / or closes.

[0244] FIG. 15K is a side view of a cradle of the load cell assembly of FIG. 15A according to at least one exemplary embodiment.

[0245] In at least one exemplary embodiment, as shown in FIG. 15K, the cradle 1516 has a wall 1586 that at least partially defines a container region 1587. The wall 1586 may be partially cylindrical. A cap 1588 may be coupled to the wall 1586 to facilitate alignment and / or retention of the container within the container region 1587. In at least one exemplary embodiment, the cap 1588 facilitates proper removal of a container (e.g., see container 1598 in FIG. 15M) from the cradle 1516 by lifting the port end or top of the container before the bottom of the container, thereby reducing or preventing leakage of the container contents from the container's vent port.

[0246] The wall 1586 extends between a first end 1586A and a second end 1586B. In at least one exemplary embodiment, the second end 1586B of the wall 1586 includes a pair of alignment surfaces 1589. An alignment angle 1590 is defined between the alignment surfaces 1589. In at least one exemplary embodiment, the alignment angle 1590 is about 90 degrees or greater (e.g., about 100 degrees or greater, about 110 degrees or greater, about 120 degrees or greater, about 130 degrees or greater, about 140 degrees or greater, or about 150 degrees or greater). The alignment angle 1590 may be about 160 degrees or less (e.g., about 150 degrees or less, about 140 degrees or less, about 130 degrees or less, about 120 degrees or less, about 110 degrees or less, or about 100 degrees or less). The alignment surfaces 1589 cooperate to at least partially define an alignment region 1591. In at least one exemplary embodiment, the wall 1586 further defines a slot 1592 between the alignment surfaces 1589. The alignment surfaces 1589 and / or the slot 1592 can, in at least one exemplary embodiment, facilitate proper alignment of the container within the cradle 1516, as described in more detail below.

[0247] In at least one exemplary embodiment, the wall 1586 is formed with one or more receptacles 1586C. The receptacles 1586C are configured to receive at least a portion of a calibration weight. In at least the exemplary embodiment shown, the receptacles 1586C are sized and shaped to receive the bottom of a cylindrical calibration weight. When the cylindrical calibration weight is at least partially within the receptacle 1586C, the longitudinal axis of the cylindrical calibration weight is generally parallel to the central axis 1517 (shown in FIG. 15A ) of the load cell assembly 1500 (shown in FIG. 15A ).

[0248] FIG. 15L is a front view of the cradle of FIG. 15K, according to at least one exemplary embodiment.

[0249] In at least one exemplary embodiment, as shown in FIG. 15L , the cradle 1516 can be configured to hold the container in a desired orientation. The cradle 1516 defines a container angle 1594 between the bottom of the wall 1586 and a horizontal plane 1595 (i.e., a plane perpendicular to the direction of gravity). In at least one exemplary embodiment, this angle is greater than about 0 degrees (e.g., about 1 degree or more, about 2 degrees or more, about 3 degrees or more, about 5 degrees or more, or about 10 degrees or more). The container angle 1594 can be about 45 degrees or less (e.g., about 40 degrees or less, about 35 degrees or less, about 30 degrees or less, about 25 degrees or less, about 20 degrees or less, about 15 degrees or less, about 10 degrees or less, about 8 degrees or less, or about 5 degrees or less).

[0250] FIG. 15M is a perspective view of a container within the cradle of FIG. 15K according to at least one exemplary embodiment.

[0251] In at least one exemplary embodiment, as shown in FIG. 15M, the cradle 1516 is configured to hold the container in a desired orientation. In at least the exemplary embodiment shown, the container is a bottle 1598. The bottle 1598 may be similar to or the same as the bottle 1900 of FIG. 19A. The bottle 1598 has a cap 1598A. The cap 1598A has a protrusion 1598B that includes a pair of container alignment surfaces 1598C, a pair of side surfaces 1598D, and an opposing surface 1598E. The cap 1598A further has a fluid port 1598F and a vent port 1598G. In at least one exemplary embodiment, when the bottle 1598 is placed in the cradle 1516 for use, the vent cap 1598H is removed from the vent port 1598G, and a tube and connector are connected to the fluid port 1598F (see, e.g., FIGS. 19I and 19J).

[0252] In at least one exemplary embodiment, when the bottle 1598 is properly positioned within the cradle 1516, the protrusion 1598B is at least partially positioned within the alignment area 1591. The alignment surface 1589 of the cradle 1516 engages (e.g., directly contacts) the container alignment surface 1598C, and the fluid port 1598F is at least partially positioned within the slot 1592. Thus, the vent port 1598G is positioned higher than the fluid port 1598F, i.e., above a predetermined (or desired) liquid level. In this configuration, the fill capacity of the bottle 1598 is increased or maximized compared to other placements because the top placement of the vent port 1598G allows for a larger fill volume without the contents spilling through the vent port 1598G. Furthermore, this configuration can reduce or minimize residual volume so that fluid can be withdrawn from the bottle 1598 without drawing in air. The container 1598 is positioned at a container angle 1594. The container angle 1594 may be selected to balance the required holdup amount with a high fill volume.

[0253] In at least one exemplary embodiment, as described in more detail below with reference to FIGURE 26J, the bottle 1598 and / or cap 1598A may be sized and molded to ensure that the cap 1598A of the bottle 1598 is properly positioned in the cradle 1516 below the bottom of the bottle 1598. That is, the cap 1598A is positioned toward the first end wall 1586A and the bottom of the bottle 1598 is positioned toward the second end wall 1586B.

[0254] In at least one exemplary embodiment, the bottle 1598 and cradle 1516 include one or more features to facilitate visual identification of improper installation. A user can easily identify when the bottle 1598 is positioned at an angle other than the container angle 1594 ( FIG. 15K ), i.e., when the longitudinal axis of the bottle 1598 is not parallel to the cradle 1516. Additionally or alternatively, a user can easily identify when the container alignment surface 1598C is not fully seated on the alignment surface 1589 of the cradle 1516. Additionally or alternatively, a user may identify when the ports 1598F, 1598G are not vertically aligned, with the fluid port 1598F in the slot 1592. Additionally or alternatively, a user may identify when the label 1598I on the bottle 1598 is not visible, facing up, and / or is approximately centered within the cradle 1516.

[0255] On the other hand, in at least one exemplary embodiment, when the bottle 1598 is improperly oriented in the cradle 1516, the opposing surfaces engage one or both of the alignment surfaces 1589, thereby preventing the protrusion 1598B from being within the alignment region 1591. In the improper orientation, fluid can be forced out of the bottle 1598 through the vent port 1598G, which is below the liquid level in the improper orientation. If the flow were to reverse, air would be drawn from the bottle 1598 rather than the intended fluid.

[0256] An exemplary aspect relates to a bottle tray load cell assembly comprising: a load cell including a support bracket, a fixed side, and a load deflection side offset from the fixed side, wherein the fixed side of the load cell is attached to the support bracket; and an interface plate attached to the load deflection side of the load cell, the interface plate including a body, a first magnet recess disposed in the body, and a plurality of cam lobe valleys disposed at least partially around the first magnet recess, wherein the plurality of cam lobe valleys interrupt a first contact surface of the body; the interface plate; a mandrel; a cam body; a second magnet recess; and the plurality of cam lobes. a support bar having a first contact surface of the body, the mandrel extending along the longitudinal axis from a first end to a second end, a cam body disposed at the second end of the mandrel, a second magnet recess disposed on the cam body, a plurality of cam lobes extending from the cam body and disposed at least partially around the second magnet recess, the support bar being movable between an engaged state with respect to the interface plate and a disengaged state with respect to the interface plate, wherein in the engaged state the plurality of cam lobes are disposed in contact with the plurality of cam lobe valleys, and in the disengaged state the plurality of cam lobes are disposed without contacting the plurality of cam lobe valleys and are in contact with the first contact surface of the body.

[0257] Any one or more of the above aspects further include a first magnet disposed in the first magnet recess and including a first pole having a first polarity, the first pole facing away from the direction toward the body of the interface plate, and a second magnet disposed in the second magnet recess and including a second pole having a second polarity, the second pole facing away from the direction toward the cam body of the support bar, the first pole facing the second pole and the first polarity opposite the second polarity. In any one or more of the above aspects, the support bar is maintained in engagement with the interface plate by a magnetic force between the first magnet and the second magnet, and a first movement of the support bar relative to the interface plate moves the support bar a distance from the interface plate to move the support bar from engagement with the interface plate to disengagement from the interface plate. In any one or more of the above aspects, the first motion includes a rotational motion about the longitudinal axis, the rotational motion including a force greater than the magnetic force. In any one or more of the above aspects, further comprising a collection cradle fixedly attached to the first end of the mandrel. In any one or more of the above aspects, the load deflection side moves independently of the support bracket. In any one or more of the above aspects, the plurality of cam lobe valleys includes at least three cam lobe valleys asymmetrically disposed about an axis extending through a center of the first magnet recess, the plurality of cam lobe segments including at least three cam lobe segments. In any one or more of the above aspects, the at least three cam lobe segments engage with the at least three cam lobe valleys in only one rotational orientation about the axis extending through the center of the first magnet recess. In any one or more of the above aspects, the support bar, in a disengaged state, rotates about the longitudinal axis without imparting a rotational force to the load cell via the interface plate.

[0258] An exemplary aspect is a method of disengaging a support member from a weigh scale assembly, the method including the steps of providing a load cell assembly, the load cell including a support bracket, a fixed side, and a load deflection side offset from the fixed side, the fixed side of the load cell attached to the support bracket; an interface plate attached to the load deflection side of the load cell, the interface plate including a body, a first magnet recess disposed in the body, and a plurality of cam lobe valleys disposed at least partially about the first magnet recess, the plurality of cam lobe valleys intercepting a first contact surface of the body; and a support bar having a mandrel, a cam body, a second magnet recess, and a plurality of cam lobes, the mandrel extending along a longitudinal axis from a first end to a second end, the cam body disposed at the second end of the mandrel, the second magnet recess disposed in the cam body, the plurality of cam lobes extending from the cam body, the plurality of cam lobes at least partially intercepting a first contact surface of the body. the support bar is disposed around the second magnet recess, the support bar being movable between an engaged state with the interface plate and a disengaged state with respect to the interface plate, wherein in the engaged state the plurality of cam lobe portions are disposed in contact with the plurality of cam lobe valleys, and in the disengaged state the plurality of cam lobe portions are disposed without contacting the plurality of cam lobe valleys and in contact with the first contact surface of the body; positioning the support bar in an engaged state with the interface plate, wherein the plurality of cam lobe portions are disposed in contact with the plurality of cam lobe valleys; moving the support bar from the engaged state to the disengaged state by receiving a force moving the support bar, the force moving the support bar comprising a rotational force about the longitudinal axis; and moving the support bar in the disengaged state independently of the interface plate and without applying a specific rotational force to the interface plate and the load cell.

[0259] Examples of how apheresis systems communicate In at least one exemplary embodiment, the apheresis system 200 described herein includes one or more computer systems, such as computer system 1627. The processor 1630 of computer system 1627 is configured to execute one or more of the processes and methods described herein. The processor 1630 may execute software. For example, the software may include firmware, applications, and / or an operating system that manages the execution of the apheresis system 200.

[0260] The software, including firmware, applications, operating systems, and other programmable features of apheresis system 200, is updated from time to time as needed to ensure the operation of apheresis system 200.

[0261] Apheresis system 200 may include, among other things, applications for fleet management and allowing customers to install software on a fleet of machines in bulk. The software system implemented by apheresis system 200 may be configured to generate and / or compile a device log (D-log) for transmission to a cloud storage location. The D-log may be used for predictive analytics or other purposes. Each apheresis system 200 may communicate with a remote system server 1621 (e.g., via communications network 1618, in the cloud, etc.), as shown in FIG. 16B. During startup, each apheresis system 200 communicates information about its software, including firmware version, encountered error logs, etc., with server 1621 using a method similar to that shown in FIG. 16A.

[0262] System server 1621 is configured to determine whether the software and / or firmware version of apheresis system 200 requires an update (e.g., is out of date, etc.). In at least one exemplary embodiment, system server 1621 may automatically perform the software and / or firmware update or may present the user with an option to update the software and / or firmware. In at least one exemplary embodiment, an external device may be connected to apheresis system 200 to update the software. For example, the external device may be a computer or laptop connected to apheresis system 200 and configured to update the software of apheresis system 200. In either case, if the software for apheresis system 200 is not updated, apheresis system 200 is prevented from operating. This prevention is based on a lock signal transmitted by system server 1621 or a lock signal transmitted by apheresis system 200 that has not received an unlock signal from system server 1621 that enables operation.

[0263] The method of Figure 16A begins at 1600, when apheresis system 200 is off or unused. At 1603, apheresis system 200 is powered on and performs a power-on process. As shown in Figure 16D, computer system 1627 is configured to detect activation of apheresis system 200 or to automatically perform the processes described herein upon activation.

[0264] In response to detecting the activation, computer system 1627 transmits data to server 1621 via a connection to network 1618, as shown in Figure 16B. The data transmitted to server 1621 comprises one or more of a data log, a firmware version identifier, and an error log.

[0265] At 1609, apheresis system 200 receives a response from server 1621 in response to the data transmitted to server 1621. Server 1621 is configured to determine, based on the data, whether the software of apheresis system 200 is currently the most recent and / or up-to-date version. If the software is outdated, i.e., not the most recent version, server 1621 transmits a lockout signal or other type of data packet, instructing apheresis system 200 to update the software before use. In at least one exemplary embodiment, apheresis system 200 cannot be used until positive confirmation that the software is up-to-date is received from server 1621 via network connection 1618. In this manner, risks associated with using an apheresis system 200 that has not been updated can be avoided. For example, at 1612, apheresis system 200 can be prevented from use based on the response received from the server.

[0266] In at least one exemplary embodiment, if server 1621 determines that the software is not updated, the server may send one or more files to update the software as part of its response. Additionally or alternatively, the software of apheresis system 200 may be updated automatically. For example, a software update may be initiated automatically after receiving one or more files to update the software from the server. In at least one exemplary embodiment, apheresis system 200 may allow a user to manually update the system when one or more files to update the software are received. For example, a user may manually initiate a software update after receiving one or more files. Once the software is updated, apheresis system 200 is configured to unlock and enable use of the system.

[0267] In at least one exemplary embodiment, the method shown in FIG. 16A may further include determining whether an unlock requirement has been met after disabling the use of the apheresis device. For example, the unlock requirement may include a proper update of software. In response to determining that the unlock requirement has been met, the apheresis system 200 becomes available for use.

[0268] In at least one exemplary embodiment, as shown in FIG. 16C, a message can be displayed on the graphical user interface 1624 of the apheresis system 200. The message notifies the user whether the apheresis system 200 is locked due to old software that is not up-to-date and, if necessary, enables the user to manually install a software update. In at least one exemplary embodiment, the user may manually initiate the installation of a software update using the graphical user interface (GUI) 1624. In other embodiments, the user may connect an external device including a software update to the apheresis system 200 to initiate and install the software update.

[0269] At least one exemplary embodiment relates to a method including detecting activation of an apheresis device, transmitting data to a server in response to the detection of activation, receiving a response from the server in response to the data, and disabling the use of the apheresis device based on the response from the server.

[0270] In aspects of the above embodiment, the data sent to the server includes one or more of a data log, a firmware version identifier, and an error log. In aspects of the above embodiment, the response includes a lockout signal. In aspects of the above embodiment, the response includes a firmware update. In aspects of the above embodiment, the firmware update is automatically installed. In aspects of the above embodiment, the apheresis device exits the disabled state after installing the firmware update. In aspects of the above embodiment, the firmware update is manually installed by a user. In aspects of the above embodiment, the response includes displaying a message on a graphical user interface based on the response from the server. In aspects of the above embodiment, the graphical user interface allows a user to initiate the firmware installation. In aspects of the above embodiment, after disabling use of the apheresis device, determining whether an unlocking requirement has been met, and enabling use of the apheresis device in response to determining that the unlocking requirement has been met. In aspects of the above embodiment, the unlocking requirement is associated with updated firmware.

[0271] Example methods and processes for providing feedback in a blood collection process Apheresis system 200 has one or more interface elements (e.g., a display device, LEDs, alarms, etc.) that provide instructions to the user and / or donor 102 regarding information about the blood collection process. In one example, these interfaces indicate to donor 102 that they should make a squeezing motion (e.g., when pressure or flow rate drops below a predetermined threshold). Additionally or alternatively, the interface elements can indicate to donor 102 how far along the blood collection process is. In either case, this feedback is provided by apheresis system 200 as an audio and / or visual output (e.g., via one or more speakers, display devices, LEDs, etc.). In at least one exemplary embodiment, an LED is located on the side of apheresis system 200 that provides this feedback to donor 102.

[0272] The method illustrated by the flowchart of Figure 17A begins at 1700. At the start of the method, an apheresis system, such as apheresis system 200, is powered on and connected to a donor, such as donor 102.

[0273] In 1703, the computer system of the apheresis system 200 detects the start of a blood draw process. In at least one exemplary embodiment, detection itself is not required; instead, the method illustrated in FIG. 17A may occur automatically as part of the blood draw process. For example, detecting the start of a blood draw process may include initiating the blood draw process. In at least one exemplary embodiment, detecting the start of a blood draw process may include detecting fluid flow, for example, by using one or more sensors, such as fluid sensor 316.

[0274] Once the blood collection process begins in 1706, the apheresis system provides an output perceptible by the donor 102. For example, the output may be a light, a sound, a GUI display, or the like. The output may be provided with the donor 102 in mind. In at least one exemplary embodiment, an output 1724 is provided on the side of the apheresis system 200, as shown in FIG. 17B. For example, the output 1724 includes an array of lights, such as light-emitting diodes (LEDs). While the output 1724 is illustrated as being on a particular side of the apheresis system 200, it should be understood that the output may be provided on any side of the apheresis system 200 and may be within range of the donor 102 such that the output can be seen or heard by the donor 102.

[0275] In at least one exemplary embodiment, output 1724 may be a display device. For example, output 1724 may illuminate or emit light in a manner that visualizes to the donor or other user of the apheresis system information such as the time remaining in the blood collection process, whether the donor should squeeze their hand to improve blood flow to the apheresis system, or other information. Output 1724 may be configured to illuminate or emit light in a pulsed manner, and the light pulse rate may be synchronized with the number of squeezes per unit time (squeeze rate) that the donor should squeeze their hand to achieve optimal flow rate.

[0276] At 1709, the method determines the percentage of the blood collection process completed and / or the percentage of the blood collection process remaining. For example, this may include determining the time remaining in the blood collection process. Determining the time remaining may first include determining the amount of plasma expected to be donated by the donor 102. Determining the amount of plasma expected to be donated by the donor may include receiving donor information as part of the initiation process. For example, the donor information may be received from the donor's ID card via a reader or scanner, such as reader 1221 described above.

[0277] Determining the time remaining includes dividing the amount of plasma expected to be provided by the donor by the expected flow rate. For example, if apheresis system 200 determines that the expected amount of plasma yet to be collected is 1 liter, and plasma is expected to be collected at a flow rate of 1 liter per minute, apheresis system 200 can determine that there is 1 minute remaining in the blood collection process.

[0278] At 1712, the method updates the output in response to determining the time remaining in the blood collection process.

[0279] In at least one exemplary embodiment, updating an output, such as output 1724, includes adjusting the number of light emitters or the percentage of the display that is lit. For example, as shown in FIGS. 17C-17E, output 1724 has five light emitters 1727a-1727e. Each of the five light emitters 1727a-1727e independently illuminates based on the amount of time remaining. Additionally, as described above, light emitters 1727a-1727e may be capable of pulsating, i.e., the brightness of each light emitter is independently adjusted to achieve a pulsating effect.

[0280] As shown in FIG. 17C, each light on output 1724 may be turned off or otherwise not illuminated to inform the donor that the blood collection process has just begun. As shown in FIG. 17D, a portion of lights 1727a-1727e may be illuminated based on the amount of time remaining in the blood collection process relative to the total time. For example, if the blood collection process is 60% complete, 60% of the lights may be illuminated. As shown in FIG. 17E, all lights on output 1724 may be illuminated to inform the donor that the blood collection process is complete or nearly complete. In at least one exemplary embodiment, the color of lights 1727a-1727e on output 1724 may change upon completion of the blood collection process.

[0281] At 1715, the method detects a loss of pressure. Detecting a loss of pressure includes detecting that the pressure of the fluid in the apheresis device 200 has dropped below a predetermined threshold. The loss of pressure may be due to poor blood circulation in the donor 102, collapsed veins, insufficient pump power, or other reasons. In some cases, the donor 102 may be required to squeeze their hand to increase the flow rate to the apheresis system 200. By squeezing their hand at a particular squeezing speed, the donor 102 can control the flow rate to the apheresis system 200.

[0282] In 1718, in response to detecting a loss of pressure, the method updates output 1724. For example, in response to detecting a loss of pressure, apheresis system 200 updates output 1724 so that output 1724 instructs donor 102 to perform a squeezing action. Updating output 1724 to instruct the donor to perform a squeezing action may include blinking, for example, one or more of lights 1727a-1727e on and off. In at least one exemplary embodiment, the brightness of one or more of lights 1727a-1727e pulses at a particular rate. The rate at which the lights pulse or blink is based on the particular flow rate required to complete the blood collection process.

[0283] At 1721, the method terminates when the blood collection is complete. In at least one exemplary embodiment, terminating the method may include detecting the end of the blood collection process. Terminating the method may include turning off output 1724. For example, after detecting and terminating the blood collection process, apheresis system 200 executes an output routine that indicates to donor 102 that the blood collection process is complete. Such an output routine may include one or more of: flashing lights on output 1724 in a particular sequence, changing the color of lights on output 1724, emitting noise, or other discernible output, thereby indicating to donor 102 that the blood collection process is complete. After the output routine, the device or system stops emitting noise and turns off all lights.

[0284] In at least one exemplary embodiment, during the blood collection process, apheresis system 200 may be configured to detect an alarm event and, in response, alert a user regarding the alarm. For example, during the plasma collection process, a computer system or microcontroller processor within apheresis system 200 may be configured to detect factors such as temperature, pressure, flow rate, color, weight, input data from a scanner, or other factors. If any of the factors are invalid, too high, too low, etc., the processor may generate a graphical output that alerts the user regarding the alarm event and / or instructs the user regarding how to resolve the alarm event.

[0285] Detecting alarm events associated with an apheresis system includes monitoring factors such as temperature, pressure, flow rate, fluid color, weight of plasma received, data received from the scanner, motor control, centrifuge speed, software failure modes, and / or other factors related to the collection process.

[0286] Detecting an alarm event may include receiving data from one or more sensors, such as a temperature sensor, a pressure sensor, a flow sensor, a color sensor, a valve sensor, a weight sensor, a scanner, or other device.

[0287] Sensors may be located throughout the apheresis system 200 and may be configured to monitor multiple aspects of the collection process, such as the weight of the plasma collection bottle, the flow rate and pressure of the tubing, the centrifuge speed, and / or other factors.

[0288] An alarm event is detected when one of the factors exceeds a threshold or reaches a specific value. The threshold may be an upper or lower threshold, or a specific amount or range. For example, for an alarm related to the color of a fluid, the threshold may be a specific color or a specific color range.

[0289] The threshold may be associated with a time or time range. For example, an alarm event may be detected when data received from the scanner, such as donor identification data, is not current or out of date. In at least one exemplary embodiment, an alarm event may be detected when data received from the scanner indicates one or more of an outdated instrument or device, an incorrect instrument or device, and an incompatible instrument or device.

[0290] In at least one exemplary embodiment, an alarm event may be based on data from multiple sensors. For example, an alarm event may occur when both pressure and temperature exceed certain thresholds.

[0291] After detecting an alarm, the processor may generate or retrieve a graphical display output based on the detected alarm event.

[0292] Generating a graphical display output may include providing text describing the alarm event, providing one or more images describing the alarm event, and / or providing other content intended to instruct the user on how to resolve the alarm.

[0293] Retrieving the graphical display output may include retrieving from memory one or more of text describing the alarm event, one or more images describing the alarm event, and / or other content intended to instruct the user on how to resolve the alarm.

[0294] The instructions include at least one instruction to transition apheresis system 200 from an alarm state to an operational state. The instructions to transition apheresis system 200 from an alarm state to an operational state may include visual aids and / or text to inform the user about what steps can be taken to resolve the problem causing the alarm event. For example, the instructions may include information instructing the user to perform one or more of the following: connect tubing, close latches, and remove kinks in tubing. In at least one exemplary embodiment, the instructions may include instructing the user to terminate the blood collection process and disconnect apheresis system 200 from the donor.

[0295] After generating and / or retrieving the graphical display output based on the detected alarm event, the processor renders the graphical display output on a graphical user interface of the apheresis system.

[0296] In at least one exemplary embodiment, the processor may illuminate one or more light-emitting diodes (LEDs) and / or output an audible sound upon detection of an alarm event, in addition to or instead of rendering a graphical display output in a GUI such as GUI 1230 shown in FIG. 12B. The LEDs may be switchable between multiple colors, such as orange, yellow, red, and cyan. The color of the LED may be selected by the processor to correspond to the type of alarm event detected. In at least one exemplary embodiment, the LEDs may include one or more light emitters 2339, as described below with respect to FIG. 22C.

[0297] In at least one exemplary embodiment, each color may be associated with a different type and / or level of alarm, for example, the type of alarm may indicate that the alarm is associated with one or more of temperature, pressure, flow rate, color, and weight.

[0298] The level of the alarm may indicate, for example, the severity or priority of the alarm. In at least one exemplary embodiment, different thresholds may be used to determine whether a particular factor is at a mild or severe level. For example, if normal pressure is 10 PSI, a mild level alarm may be set for pressures below 5 PSI, and a severe level alarm may be set for pressures of zero PSI. In at least one exemplary embodiment, a high severity alarm may be red. In at least one exemplary embodiment, a medium priority alarm may be yellow or orange. In at least one exemplary embodiment, a low priority alarm may be green or blue. In at least one exemplary embodiment, if no alarm event is detected, the light is off or not illuminated.

[0299] In at least one exemplary embodiment, the level of severity or priority of an alarm may be indicated by a flashing or blinking light. The rate at which the light flashes may also indicate the severity of the alarm. For example, a light that flashes at a faster rate or tempo may indicate a higher severity and priority, and a light that flashes at a slower rate or tempo may indicate a lower priority.

[0300] In at least one exemplary embodiment, the audible alert or tone indicates the level of severity or priority of the alarm event. For example, different tones, different sound patterns, and different audio frequencies can indicate the level of priority. For example, a higher frequency tone may indicate a higher priority alarm event, while a lower frequency tone may indicate a lower priority alarm event. In at least one exemplary embodiment, the number of times the tone is emitted per unit of time may indicate the level of severity of the alarm event. For example, a tone, such as a beep, occurring more frequently within a certain period of time indicates a higher priority alarm event.

[0301] The color of an alarm may be set based on both the type and severity of the alarm, for example, a temperature alarm may be a blue light, and the brightness or hue of the color may be adjusted based on the severity of the alarm.

[0302] In at least one exemplary embodiment, the graphical display output may include a timestamp indicating the time the alarm event occurred.

[0303] In at least one exemplary embodiment, the graphical display output may include a description of the alarm and a list of actions to resolve the alarm.

[0304] In at least one exemplary embodiment, the graphical display output may include a diagram associated with the alarm event, for example, displaying a photograph or diagram to instruct the user on how to resolve the alarm condition.

[0305] In at least one exemplary embodiment, the graphical display output includes GUI elements that allow a user to one or more of reset, continue, and terminate the blood collection process.

[0306] In at least one exemplary embodiment, after rendering the graphical display output, the method may include performing a system check. In at least one exemplary embodiment, the system check may be performed continuously throughout the blood collection process. Performing the system check may include polling data associated with the alarm event to determine whether the factor causing the alarm event has returned to a normal level. If the factor causing the alarm event has returned to a normal level, the alarm is resolved and terminated. In at least one exemplary embodiment, the alarm event may require the blood collection process to be terminated and the donor to be disconnected from the apheresis system 200. In such an embodiment, the system check may determine that the alarm event cannot be resolved or reversible and may generate an alarm and / or provide a way to terminate the blood collection process and disconnect the donor 102.

[0307] For example, if a temperature drop below a predetermined threshold triggers an alarm event, performing a system check may include determining whether the temperature is above or equal to the predetermined threshold.

[0308] At least one exemplary embodiment includes a method having: detecting the start of a blood collection process; providing an output in response to detecting the start of the blood collection process; determining a time remaining for the blood collection process; updating the output in response to determining the time remaining for the blood collection process; detecting a loss of pressure; updating the output in response to detecting the loss of pressure; detecting an end of the blood collection process; and updating the output in response to detecting the end of the blood collection process.

[0309] In some aspects of the above embodiments, the blood collection process is plasma collection using an apheresis device. In some aspects of the above embodiments, detecting the start of the blood collection process includes detecting fluid flow. In some aspects of the above embodiments, the output is one or more of a light and a sound. In some aspects of the above embodiments, the output is provided at the apheresis device. In some aspects of the above embodiments, the output is within range of the donor and one or more of a donor's view and a donor's hearing. In some aspects of the above embodiments, the output is a display device. In some aspects of the above embodiments, the display device displays a series of lights. In some aspects of the above embodiments, the series of lights is updated to indicate to the donor the time remaining in the blood collection process. In some aspects of the above embodiments, the series of lights is pulsed to instruct the donor to squeeze. In some aspects of the above embodiments, the pulsed lights are provided at a tempo related to the number of squeezes per unit time the donor makes to maintain pressure. In some aspects of the above embodiments, detecting a loss of pressure includes detecting that the pressure of the fluid in the apheresis device has dropped below a predetermined threshold. In some aspects of the above embodiments, updating the output in response to detecting a loss of pressure includes instructing the donor to perform a squeezing motion. In some aspects of the above embodiments, updating the output in response to detecting the end of the blood collection process includes ceasing an audible noise or turning off a light.

[0310] At least one exemplary embodiment of the present disclosure includes a method comprising detecting an alarm event associated with an apheresis system, retrieving a graphical display output based on the detected alarm event, and rendering the graphical display output on a graphical user interface of the apheresis system.

[0311] In some embodiments of the above method, the method is performed by an apheresis system used to perform a plasma collection process. In some embodiments of the above method, the alarm event is associated with one or more of the following factors: temperature, pressure, flow rate, fluid color, receipt of an excessive amount of plasma, and data received from a scanner. In some embodiments of the above method, the alarm event includes association with expired data received from the scanner. In some embodiments of the above method, the alarm event is detected when one of the above factors exceeds a threshold. In some embodiments of the above method, detecting the alarm event includes receiving data from one or more sensors. In some embodiments of the above method, reading the graphical display output includes generating the graphical display output. In some embodiments of the above method, the graphical display output includes instructions describing the alarm event. In some embodiments of the above method, the instructions include at least one instruction for transitioning the apheresis system from an alarm state to an operating state. In some embodiments of the above method, the instructions include instructing a user to perform one or more of connecting tubing, closing a latch, and removing a kink from the tubing. Some aspects of the method include illuminating a light-emitting diode (LED) when an alarm event is detected. In some aspects of the method, a color of the LED is selected by the processor to correspond to a type of the detected alarm event, the color being selected from orange, yellow, red, and cyan, and the alarm type being associated with one or more of temperature, pressure, flow rate, color, and weight. Some aspects of the method include performing a system check after rendering the graphical display output. In some aspects of the method, performing the system check includes polling for data associated with the alarm event. In some aspects of the method, the graphical display output includes a timestamp indicating a time when the alarm event occurred.In some aspects of the above method, the graphical display output includes a diagram associated with the alarm event. In some aspects of the above method, the diagram instructs the user to resolve the alarm condition. In some aspects of the above method, the graphical display output includes a description of the alarm and a list of actions to resolve the alarm. In some aspects of the above method, the graphical display output includes GUI elements that enable the user to one or more of reset, continue, and terminate the blood collection process.

[0312] Modular maintenance sled and interconnection examples In at least one exemplary embodiment, an apheresis system (e.g., apheresis system 200 or apheresis system 1800) includes one or more subsystems (e.g., power subassembly, pneumatic control subassembly, communication subassembly, pumps 208, 212, 216, bottle tray load cell assembly 1500, etc.) mounted on a sled or mechanical frame that can be completely separated from the apheresis system for inspection, maintenance, and / or replacement. The modular service sled includes one or more mechanical and / or electrical interconnections that can be selectively decoupled from one or more corresponding mechanical and / or electrical interconnections on the apheresis system. Once decoupled, an entire subsystem on a particular modular service sled can be removed from the apheresis system, for example, independently of the other subsystems and the modular service sled.

[0313] In at least one exemplary embodiment, a modular maintenance sled may be separated into individual and / or combination subsystem sleds. For example, one modular maintenance sled may include multiple pneumatic systems (e.g., two or more manifolds, valves, etc.) for an apheresis system, another modular maintenance sled may include multiple electrical systems (e.g., two or more processors, controllers, memory devices, power supplies, wiring harnesses, connectors, etc.), and / or another modular maintenance sled may include electrical and / or mechanical subsystems that are grouped together based on predicted and / or past maintenance requirements.

[0314] In at least one exemplary embodiment, one or more of pumps 208, 212, 216 (shown in FIG. 2A ) are quickly replaceable by removing a limited number of fasteners (e.g., screws, bolts, nuts, etc.) associated with each modular service sled. After the fasteners are removed, each of the modular service sleds and its associated systems (e.g., pumps 208, 212, 216) can be removed entirely from the apheresis system without requiring disassembly of the apheresis system and / or removal of other panels, frames, etc.

[0315] Among other things, these modular service sleds allow components to be quickly isolated from the apheresis system and serviced separately from the apheresis system. In at least one exemplary embodiment, once a modular service sled is removed from the apheresis system, a different (e.g., new, refurbished, etc.) modular service sled may be replaced in the apheresis system, and the apheresis system may continue to operate (e.g., while the removed modular service sled is serviced, returned to manufacturing, or repaired / reworked). This approach allows subsystem replacements to be performed in one minute, among other things, improving apheresis system operability and reducing downtime compared to the maintenance required for other apheresis systems, which may take several hours or more to service.

[0316] FIG. 18A is a partially exploded perspective view of an apheresis system including a modular service sled, according to at least one exemplary embodiment.

[0317] In at least one exemplary embodiment, as shown in FIG. 18A , an apheresis system 1800 includes one or more modular service sleds 1802. The apheresis system 1800 may be similar to the apheresis system 200 of FIG. 1. In at least the exemplary embodiment shown, the sleds 1802 include a first sled 1802A, a second sled 1802B, a third sled 1802C, a fourth sled 1802D, a fifth sled 1802E, a sixth sled 1802F, a seventh sled 1802G, an eighth sled 1802H, and a ninth sled 1802I (collectively referred to as “sleds 1802”). The apheresis system 1800 may further include a base assembly 1804. The base assembly 1804 may define a plurality of receiving spaces. Receiving space 1806 may be defined in any surface (or surfaces) of base assembly 1804, including the top, sides, and / or back, etc. Each of sleds 1802 may reside at least partially within one of the receiving spaces 1806. Each of sleds 1802 includes a modular frame configured to selectively engage with an apheresis system, as described in more detail below.

[0318] In at least one exemplary embodiment, the base assembly 1804 includes a housing 1804A and a frame 1804B. The housing 1804A may include plastic, and the frame 1804B may include metal. In at least one other exemplary embodiment, the base assembly may include a unitary housing and frame. In at least one exemplary embodiment, the housing 1804A includes a sloped or contoured region 1807 around some or all of the receiving space 1806. The sloped or contoured region 1807 is configured to direct fluid away from the sled 1802 (e.g., the gasket 1818 of the sled 1802) to reduce or prevent pooling of liquid near the gasket 1818 and / or to facilitate cleaning of the housing 1804A.

[0319] In at least one exemplary embodiment, the first modular service sled 1802A includes a draw pump. The draw pump may be similar to or the same as the draw pump 208 of FIG. 2A. The draw pump may be configured with power, electrical communication, and pneumatic connections to the base assembly 1804. The first modular service sled 1802A includes a perimeter or fluid gasket and a shielding component configured to engage the base assembly 1804.

[0320] In at least one exemplary embodiment, the second modular service sled 1802B includes a return pump. The return pump may be similar to or the same as the return pump 212 of FIG. 2A. The return pump may be configured with power, electrical communication, and pneumatic connections to the base assembly 1804. The second modular service sled 1802B includes a perimeter or fluid gasket and a shielding component configured to engage the base assembly 1804.

[0321] In at least one exemplary embodiment, the third modular service sled 1802C includes an AC pump. The AC pump may be similar to or the same as the AC pump 216 of FIG. 2A. The AC pump may be configured with power and electrical communication connections with the base assembly 1804. The third modular service sled 1802C includes a perimeter or fluid gasket and a shielding component configured to engage the base assembly 1804.

[0322] In at least one exemplary embodiment, the fourth sled 1802D includes a fluid valve control system that may be similar to or the same as the fluid valve control system 228 of FIG. 2A. The fluid valve control system may be configured with power, electrical communication, and pneumatic connections to the base assembly 1804. The fourth modular service sled 1802D includes a perimeter or fluid gasket and a shielding component configured to engage the base assembly 1804.

[0323] In at least one exemplary embodiment, the fifth sled 1802E includes a bottle tray load cell assembly. The bottle tray load cell assembly may be similar to or the same as the load cell assembly 1500 of FIGS. 15A-15M. The bottle tray load cell assembly may be configured to have power and signal connections with the base assembly 1804. The fifth modular service sled 1802E includes a perimeter or fluid gasket and a shielding component configured to engage the base assembly 1804.

[0324] In at least one exemplary embodiment, the sixth sled 1802F includes a user interface device or screen. The user interface device may be configured with power and signal connections to the base assembly 1804. The sixth modular service sled 1802F includes a perimeter or fluid gasket and a shielding component configured to engage the base assembly 1804.

[0325] In at least one exemplary embodiment, the seventh sled 1802G has a barcode scanner configured to have power and signal connections with the base assembly 1804. The seventh modular service sled 1802G has a peripheral or fluid gasket and a shielding component configured to engage the base assembly 1804.

[0326] In at least one exemplary embodiment, the eighth sled 1802H includes a soft cassette assembly. The soft cassette assembly may be similar to or the same as the soft cassette assembly 300 of FIG. 3A. The soft cassette assembly may be configured to include power, electrical communication, and pneumatic connections with the base assembly 1804. The eighth modular service sled 1802H includes a peripheral or fluid gasket and a shielding component configured to engage the base assembly 1804.

[0327] In at least one exemplary embodiment, the ninth sled 1802I includes a hanger assembly (e.g., for the AC and / or saline bag). The hanger assembly may be similar or the same as the first and second hanger assemblies 2200, 2202 of FIG. 21A. One or both of the hanger assemblies (e.g., the hanger assembly for the saline bag) may be configured with a power connection to the base assembly 1804. The ninth modular service sled 1802I includes a peripheral or fluid gasket and a shielding component configured to engage the base assembly 1804.

[0328] In at least one exemplary embodiment, when the modular service sled 1802 is in its respective receiving space 1806 of the apheresis system 1800 and coupled to the base assembly 1804, the interior region 1808A of the apheresis system 1800 is electrically shielded from the exterior region 1808B of the apheresis system 1800 via at least one metal component (e.g., a base plate, a shielding gasket) between the interior region 1808A and the exterior region 1808B, as shown and described below with reference to FIG. 18D.

[0329] 18B is a schematic cross-sectional view of the modular service sled of the apheresis system of FIG. 18A in a disengaged state, according to at least one exemplary embodiment.

[0330] In at least one exemplary embodiment, sled 1802 (e.g., sleds 1802A, 1802B, 1802C, 1802D, 1802E, 1802F, 1802G, 1802H, 1802I) has a base plate 1814, an internal support structure 1816, a gasket 1818 (e.g., a perimeter gasket or a fluid gasket), and a shielding component 1820. In the illustrated exemplary embodiment, gasket 1818 and shielding component 1820 are separate components, although in other exemplary embodiments, a single component may be configured to replace gasket 1818 and shielding component 1820. In at least one exemplary embodiment, internal support structure 1816 is an internal support panel. One or more of the base plate 1814 , the internal support structure 1816 , the gasket 1818 , and the shielding component 1820 may cooperate to define a modular frame 1822 .

[0331] In at least one exemplary embodiment, the modular service sled 1802 includes at least one internal system subassembly 1824 attached to a modular frame (e.g., one or more of a base plate 1814 and an internal support structure 1816). The internal system subassembly 1824 may be attached to the base plate 1814 and / or the internal support structure 1816 via a first bracket 1826 and / or a second bracket 1828. The brackets 1826, 1828 may be independently selected from standoffs, washers, captured nuts, sheet metal adapters, spacer blocks, other mechanical elements, or any combination thereof.

[0332] In at least one exemplary embodiment, internal system subassembly 1824 is a separate station, portion, or assembly of apheresis system 1800. In at least one exemplary embodiment, apheresis system 1800 includes multiple internal system subassemblies 1824. Each of internal system subassemblies 1824 may be configured to operate independently of other internal system subassemblies 1824 (e.g., on other sleds 1802).

[0333] In at least one exemplary embodiment, each of sleds 1802 includes a memory storage device (e.g., similar to or the same as memory 1008 and / or memory 1108) that forms part of internal system subassembly 1824 and / or external system subassembly 1830. The memory storage device can store, embed, or otherwise include a code that uniquely identifies sled 1802 and distinguishes it from other sleds 1802. When modular service sled 1802 is communicatively coupled to apheresis system 1800 (e.g., via at least one of interconnects 1832), apheresis system 1800 (e.g., controllers 1004, 1104, etc.) can be configured to read the code in the memory storage device to identify sled 1802.

[0334] In at least one exemplary embodiment, the internal system subassembly 1824 includes one or more threaded interconnects 1832 (e.g., two or more, three or more, or four or more). In at least the exemplary embodiment shown, the internal system subassembly 1824 includes a first threaded interconnect 1832A and a second threaded interconnect 1832B. The interconnects 1832 may be independently selected from pneumatic connections, hydraulic connections, power connections, electrical communication connections (CAN), and signal connections. In at least one exemplary embodiment, the first threaded interconnect 1832A is a pneumatic connection and the second threaded interconnect 1832B is an electrical connection (e.g., power and / or communication).

[0335] In at least one exemplary embodiment, a respective communication pathway 1834 may connect the internal system subassembly 1824 to each of the sled interconnects 1832. The base plate 1814 may include or define one or more interfaces 1836 through which the communication pathways 1834 extend. The interfaces 1836 may be independently selected from sealed and / or hermetically sealed penetrations, electrical vias, and / or passages or holes. In at least the exemplary embodiment shown, a first communication pathway 1834A connects the external system subassembly 1830 to the first sled interconnect 1832A via a first interface or passage 1836A, and a second communication pathway 1834B connects the external system subassembly 1830 to the second sled interconnect via a second interface or passage 1836B. In at least one other exemplary embodiment, two or more communication pathways extend through a common or shared interface within the base plate.

[0336] In at least one exemplary embodiment, sled 1802 further includes a gasket 1818. Gasket 1818 may be on a lower surface 1842 of base plate 1814. Gasket 1818 may be configured to engage base assembly 1804, such as housing 1804A (shown in FIG. 18A ) of base assembly 1804, to form a fluid and / or peripheral seal between interior region 1808A and exterior region 1808B (shown in FIG. 18A ) of base assembly 1804. In at least the illustrated exemplary embodiment, gasket 1818 is a flat gasket, although the gasket may have any desired cross-sectional shape, such as rectangular, square, circular, etc., and may be solid or hollow. In at least one exemplary embodiment, the gasket 1818 comprises an O-ring, an O-ring cord, a cord seal, a die-cut gasket, a foam gasket, a formed-in-place gasket (e.g., a robotically applied resin that hardens to form a gasket, a formed-in-place foam gasket), or any combination thereof.

[0337] In at least one exemplary embodiment, sled 1802 further includes a shielding component 1820. In at least the exemplary embodiment shown, shielding component 1820 is a conductive gasket (e.g., a hollow cord gasket with metal shavings therein), although the shielding component may have any desired form and may comprise a metal, including gaskets with other cross-sectional shapes or gaskets that include a metal component (e.g., a metal spring, a canted coil spring, a metalized fabric, a metal contact spring, or any combination thereof). Shielding component 1820 may be provided on a lower surface 1842 of base plate 1812 (e.g., in direct contact with a lower surface 1842 of base plate 1814). The shielding component may be configured to engage (e.g., in direct contact with) a base assembly 1804, such as frame 1804B of base assembly 1804 (shown in FIG. 18A ), when sled 1802 is attached to apheresis system 1800. Shielding component 1820 may be configured to shield against electromagnetic interference (EMI) and / or radio frequency interference (RFI). In at least the illustrated exemplary embodiment, shielding component 1820 is a shielding gasket that is concentrically located inside gasket 1818.

[0338] In at least one exemplary embodiment, thread 1802 defines one or more receptacles 1846. In at least the illustrated exemplary embodiment, receptacles 1846 are countersunk holes, while in at least one other exemplary embodiment, receptacles 1846 are through holes, countersunk holes, countersunk holes, and / or any combination thereof. In at least one exemplary embodiment, receptacles 1846 are sized and / or shaped to receive respective fasteners (see, e.g., fastener 1852 shown in FIG. 18C ) when thread 1802 is in engagement with base assembly 1804 (shown in FIG. 18D ).

[0339] FIG. 18C is a bottom perspective view of second sled 1802 according to at least one exemplary embodiment.

[0340] 18C, a second sled 1802B is provided. The second sled 1802 includes a base plate 1814′ and an internal support structure 1816′. The sled 1802B further includes a peripheral gasket 1818′ and a shielding component 1820′. The other sleds 1802A, 1802C, 1802D, 1802E, 1802F, 1802G, 1802H, 1802I can include similar features.

[0341] FIG. 18D is a schematic cross-sectional view of the modular service sled of FIG. 18B in an engaged state, according to at least one exemplary embodiment.

[0342] In at least one exemplary embodiment, as shown in FIG. 18D, the sled 1802 is operably engaged with a base assembly 1804′. The base assembly 1804′ may be a simplified version of the base assembly 1804 of FIG. 18A, in which the housing and frame are shown as one unit. However, the sled 1802 may alternatively be coupled to the base assembly 1808 of FIG. 18A, which includes a separate housing 1804A and frame 1804B.

[0343] In the engaged state, each of the threaded interconnects 1832 is operably engaged with a respective device interconnect 1850. In at least one exemplary embodiment, the threaded interconnects 1832 may be independently selected from a plug and a socket, and the device interconnect 1850 may be the other of a plug and a socket. Additionally or alternatively, the threaded interconnects may include push-to-connect type fittings, where tubing is inserted directly into the fitting and barbed fittings (e.g., for pneumatic applications). In at least the exemplary embodiment shown, the first threaded interconnect 1832A is operably connected to the first device interconnect 1850A, and the second threaded interconnect 1832B is operably connected to the second device interconnect 1850B.

[0344] In at least one exemplary embodiment, the sled 1802 is mechanically coupled to the base assembly 1804 by one or more fasteners 1852. Each of the fasteners 1852 may extend through a respective one of the receptacles 1846 of the base plate 1814 and engage the base assembly 1804 (e.g., the frame 1804B, with the housing 1804A disposed therebetween). In at least one exemplary embodiment shown, the fastener 1852 includes a flat-head cap screw (e.g., a press-fit insert in the frame 1804B) that threads into a threaded hole 1854 defined by the base assembly 1804. In at least one other exemplary embodiment, the sled 1802 may be coupled to the base assembly 1804 by other fasteners that do not necessarily use a threaded receptacle (e.g., a quarter-turn on a custom receptacle).

[0345] In at least one exemplary embodiment, sled 1802 is configured to be completely removed from apheresis system 1800 by removing fasteners 1852. In at least one exemplary embodiment, each of sleds 1802 is configured to be coupled to base assembly 1804 by a limited number of fasteners 1852 to facilitate rapid removal, replacement, and / or installation. In at least one exemplary embodiment, the number of fasteners 1852 is five or less (e.g., four or less, three or less, or two or less).

[0346] In at least one exemplary embodime...

Claims

1. 1. A method, comprising: detecting activation of the apheresis device; transmitting data to a server in response to detecting the activation; determining whether the software of the apheresis device is up to date based on the data; receiving a response from the server in response to the data; If the response indicates that the software is not up to date, disabling use of the apheresis device; having method.

2. 10. The method of claim 1, the data transmitted to the server includes one or more of a data log, a firmware version identifier, and an error log; method.

3. 10. The method of claim 1, The response includes a lockout signal. method.

4. 10. The method of claim 1, the response includes a software update. method.

5. 5. The method of claim 4, The software update includes a firmware update. method.

6. 5. The method of claim 4, The method further comprises automatically initiating installation of the software update. method.

7. 7. The method of claim 6, The method further includes the step of ending the unusable state of the apheresis device after installing the software update. method.

8. 5. The method of claim 4, The method further comprises manually initiating installation of the software update. method.

9. 10. The method of claim 1, The method further comprises displaying a message on a graphical user interface based on the response from the server. method.

10. 10. The method of claim 9, the graphical user interface allowing a user to initiate software installation; method.

11. 10. The method of claim 1, The method further comprises: determining whether unlocking requirements have been met after disabling the apheresis device; enabling use of the apheresis device in response to determining that the unlocking requirement has been met; having method.

12. 12. The method of claim 11, the unlocking requirement is associated with an update of the software; method.

13. 10. The method of claim 1, The software includes one or more of firmware, applications, and an operating system; method.

14. 10. The method of claim 1, The method further comprises manually installing the software update. method.

15. 15. The method of claim 14, manually installing the software update includes connecting an external device containing the software update to the apheresis device and installing the software update. method.

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