Methods and systems for high-throughput blood component collection

Abstract

A method and apparatus for separating components from a multi-component fluid is provided. The method for collecting blood components includes drawing whole blood 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 second blood component different from the first blood component, extracting the first blood component from the centrifuge, detecting when the second blood component is about to be extracted from the centrifuge, and, after the second blood component is detected, flowing the separated first blood component back toward the centrifuge while the centrifuge continues to rotate, thereby moving at least the second blood component from the centrifuge.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Patent Application No. 18 / 216,009, filed June 29, 2023, and the benefit of U.S. Provisional Application No. 63 / 394,417, filed August 2, 2022, the entire disclosures of which are incorporated herein by reference.

[0002] The present disclosure relates generally to the separation of components from multi-component fluids, and more particularly to apheresis methods and systems. [Background technology]

[0003] There are two common methods for donating / collecting blood. The first method is whole blood donation from a donor, followed by a centrifugation process that separates blood components from the whole blood based on their density. The desired components can be transferred to a collection container manually, semi-automatically, or automatically while the whole blood is under the influence of the force generated by the centrifuge, or sometimes afterwards. The other method is apheresis collection, which requires specialized equipment.

[0004] In the apheresis method, whole blood is extracted from a donor while the donor is connected to a dedicated device. The whole blood can be centrifuged to collect only the desired blood components (e.g., plasma), and all other undesired blood components can be returned to the donor during the same donation. The donor remains connected to the apheresis device during the separation and collection of blood components. However, the apheresis process has the disadvantage of being time-consuming and uncomfortable. In many cases, the donor must remain connected to the device for an hour to donate blood components. Therefore, making the blood donation procedure more efficient is currently desired at apheresis collection sites. Summary of the Invention [Problem to be solved by the invention]

[0005] 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 push undesired blood components back to the donor without stopping and restarting the centrifuge. Thus, the embodiments herein make the blood collection process more efficient and faster for the donor. [Means for solving the problem]

[0006] Embodiments may provide methods and devices for positioning a portion of a disposable (e.g., a loop) within a medical device. Embodiments may involve the use of a surface to automatically guide the loop. In at least one exemplary embodiment, the medical device may be a blood separation device, such as an apheresis device.

[0007] The needs mentioned above and others are addressed by various aspects, embodiments, and / or configurations, and while the present disclosure is given in terms of exemplary embodiments, it should be understood that individual aspects of the disclosure can be separately claimed.

[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 having a channel for holding a separation bladder of a disposable item, the channel having two opposing walls. The assembly also includes a loop rotation positioning guide including a plurality of bearings. The loop rotation positioning guide holds a flexible loop of the disposable item when the separation bladder is loaded into the channel.

[0009] In at least one exemplary embodiment, the loop rotation positioning 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 positioning guide. In at least one exemplary embodiment, the assembly may comprise a part of an apheresis device. In at least one exemplary embodiment, the assembly may be connected to a rotor that rotates the loop rotation positioning guide about an axis of rotation. In at least one exemplary embodiment, the plurality of bearings may include pairs of roller bearings.

[0010] In at least one exemplary embodiment, the present disclosure provides a centrifuge assembly including: a centrifuge housing having an exterior surface and an interior cavity and configured to rotate about a rotational axis of the centrifuge assembly; a fluid separation body at least partially disposed within the interior cavity of the centrifuge housing and configured to rotate relative to the centrifuge housing about the rotational axis; and a fluid line loop arm attached to a portion of the centrifuge housing and extending along a length of the exterior surface of the centrifuge housing. The fluid line loop arm includes a bearing set disposed at a point along the length of the exterior surface. The bearing set is 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.

[0011] 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 may be 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 may be 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, and 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.

[0012] 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 comprising: attaching the fluid line loop at a first end to a fluid separation body of a centrifuge assembly; and rotating the fluid separation body in a first rotational direction relative to a housing of the centrifuge assembly, the rotating fluid separation body rotating the fluid line loop relative to the housing and guiding it into a channel in 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 place relative to the housing as the centrifuge assembly rotates.

[0013] 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 relative to the housing within the channel. In at least one exemplary embodiment, the centrifuge housing may rotate in a first rotational direction at a first angular velocity about an axis of rotation, and the fluid separation body may be rotated 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 may further include attaching a second end of the fluid line loop to a point that is rotationally fixed in the apheresis device, and rotating the centrifuge assembly about the axis of rotation relative to the point that is rotationally fixed in the apheresis device via a rotor-motor assembly of the apheresis device.

[0014] In at least one exemplary embodiment, the present disclosure provides a method for collecting blood components through apheresis, including 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, flowing the separated first blood component back into the centrifuge while the centrifuge continues to rotate, and removing at least a third blood component from the centrifuge and returning it to the donor.

[0015] In at least one exemplary embodiment, the first blood component may include plasma, platelets, red blood cells, high hematocrit blood, or any combination thereof. In at least one exemplary embodiment, the second blood component may include plasma, platelets, red blood cells, high hematocrit blood, or any combination thereof. In at least one exemplary embodiment, the third blood component may include plasma, platelets, red blood cells, high hematocrit blood, or any combination thereof. In at least one exemplary embodiment, the first blood component may include two or more of plasma, platelets, red blood cells, high hematocrit blood, or any combination thereof. 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 be 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 that rotates a blood component separation bladder associated with the blood component collection set. In at least one exemplary embodiment, the blood component separation bladder may be inserted into and held in a separation insertion channel formed in the filler.

[0016] 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, and configured to move whole blood from a donor through the lumen; a draw pump engaged with the first tube and configured to draw the whole blood from the donor into a centrifuge; a centrifuge configured to rotate the whole blood to apply centrifugal force to separate the whole blood into at least a first blood component and a third blood component; a blood component separation bladder inserted into the centrifuge, fluidly associated with the first tube, and configured to separate the first blood component from the whole blood; and a blood component separation bladder fluidly associated with the blood component separation bladder and configured to separate the third blood component from the blood component separation bladder. the apheresis system includes a second tube for transferring the first blood component; a collection container fluidly associated with the second tube for extracting the first blood component from the whole blood; a sensor positioned in physical proximity to the second tube for detecting that the 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 separation bladder through the second tube and transferring at least a third blood component from the blood component separation bladder and returning it to the donor after the second blood component is detected by the sensor while the centrifuge continues to rotate.

[0017] In at least one exemplary embodiment, the first blood component may include plasma, and the second blood component may include platelets, red blood cells, high hematocrit blood, or a combination thereof. In at least one exemplary embodiment, the apheresis system may further include an anticoagulant pump configured to draw an 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 separation bladder. In at least one exemplary embodiment, the blood component separation bladder may be inserted into and held in a separation insertion channel formed in the filler.

[0018] 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 and 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 separation bladder inserted into a centrifuge and fluidly associated with the first tube to separate a first blood component and a third blood component from the whole blood; and a second blood component separation bladder fluidly associated with the blood component separation bladder to move the first blood component from the blood component separation bladder. and a collection container fluidly associated with the second tube and configured to extract a first blood component from the apheresis system, wherein a sensor is positioned in physical proximity to the second tube to detect that the second blood component is being extracted from the whole blood, and 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 separation bladder and moves at least a third blood component from the blood component separation bladder and returns it to the donor while the centrifuge continues to rotate.

[0019] 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 to the blood component separation bladder through the second tube and moves at least the third blood component from the blood component separation bladder and returns it to the donor. In at least one exemplary embodiment, the blood component separation bladder may be inserted and held within a filler that rotates the blood component separation bladder in the centrifuge. In at least one exemplary embodiment, the blood component separation bladder may be inserted and held in a separation insertion channel formed in the filler.

[0020] In at least one exemplary embodiment, the present disclosure provides a filler for holding a separation bladder in which components are separated from a complex fluid, the filler including a channel for holding the separation bladder during separation of the components from the complex fluid, the channel including a first wall and a second wall opposite the first wall, a first end of the channel adjacent a center of the filler, and the channel spiraling toward a periphery of the filler.

[0021] In at least one exemplary embodiment, the top of the channel may be narrower than the 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 top of the channel may provide reinforcement for the separation bladder during separation.

[0022] In at least one exemplary embodiment, the present disclosure provides a fluid separation filler comprising: a body having an axis of rotation located generally at the center of mass of the body; and a fluid separation insert 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 located near the outer periphery of the body, the fluid separation insert channel curving outward toward the periphery of the body near an end of the generally helical path that defines a third point of the fluid separation insert channel located furthest from the axis of rotation.

[0023] In at least one exemplary embodiment, the fluid separation filler may further include a fluid collection chamber disposed within the body and following a portion of a generally spiral path, and the fluid separation insert channel may connect to the fluid collection chamber and define 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 separation 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 separation insert 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 separation bladder into a seated position within the fluid collection chamber. In at least one exemplary embodiment, a fluid inlet for the disposable fluid separation bladder when installed within the fluid collection chamber is located adjacent to the axis of rotation, and a first fluid path of the disposable fluid separation bladder follows the generally spiral path outwardly toward an end of the disposable fluid separation bladder located adjacent the third point of the fluid separation insert channel that is located furthest from the axis of rotation, and fluidly interconnects with a second fluid path that is separate from the first fluid path of the disposable fluid separation bladder and extends inwardly from the third point following the generally spiral path to a fluid outlet for the disposable fluid separation bladder located adjacent to 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 isolation bladder, and the body of the fluid isolation 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 that positively positions the connector relative to the connection point.

[0024] In at least one exemplary embodiment, the present disclosure provides a centrifuge assembly comprising: a centrifuge housing having an internal cavity for rotation about a rotational axis of the centrifuge assembly; and a fluid separation body at least partially disposed 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 including a fluid separation 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, the fluid separation insert channel curving outward toward the outer periphery of the body near an end of the generally helical path that defines a third point of the fluid separation insert channel disposed furthest from the rotational axis.

[0025] In at least one exemplary embodiment, the fluid separation body may further include a fluid collection chamber disposed within the body and following a portion of the generally spiral path, and the fluid separation insertion channel may connect to the fluid collection chamber to define an access region between the interior of the fluid collection chamber and the exterior of the fluid separation body. In at least one exemplary embodiment, the centrifuge assembly further comprises a disposable fluid separation bladder disposed within the fluid collection chamber and following a generally spiral path, the disposable fluid separation bladder including a fluid inlet disposed adjacent the axis of rotation, a first fluid path of the disposable fluid separation bladder following a generally spiral path outwardly toward an end of the disposable fluid separation bladder disposed adjacent the third point of the fluid separation insert channel disposed furthest from the axis of rotation, and fluidly interconnecting with a second fluid path separated from the first fluid path of the disposable fluid separation bladder and extending inwardly from the third point following a generally spiral path to a fluid outlet for the disposable fluid separation 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 rotation axis that is offset from the rotation axis and generally perpendicular to the rotation axis, and the fluid separation insertion channel of the fluid separation body may be accessible in the open state and inaccessible in the closed state.

[0026] 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 opposite the first end of the flexible loop, the filler loop connector being connected to a loop connection region of the filler, such that a torsional force based on a twist in the flexible loop is imparted to the filler via the filler loop connector, wherein the flexible loop is moved in a rotational direction so as to be captured by a loop rotation positioning guide located on the centrifuge.

[0027] 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 positioning 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.

[0028] In at least one exemplary embodiment, the present disclosure provides an assembly for mounting a flexible loop, the assembly comprising: 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 for supporting the flexible loop; and a loop capture arm positioned adjacent to the channel and connected to the loop rotation positioning guide for guiding the flexible loop into the channel and contacting the loop torsion support bearing.

[0029] 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 disposed on the centrifuge to further capture the flexible loop.

[0030] In at least one exemplary embodiment, the present disclosure provides a method for automatically attaching a flexible loop to an assembly, the method including the steps of 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.

[0031] In at least one exemplary embodiment, the flexible loop may engage a loop torsion support bearing disposed within 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.

[0032] 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.

[0033] 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 the first cassette port and a second bypass branch fluidly connected to the direct flow lumen adjacent 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 have 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 a donor to the soft cassette or 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 from the centrifuge to the soft cassette. In at least one exemplary embodiment, when retracting fluid 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, which may be part of an apheresis system.

[0034] In at least one exemplary embodiment, the present disclosure provides a blood component collection set. the blood component collection set comprises 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 comprising: 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 disposed within the direct flow lumen such that fluid passing through the direct flow lumen passes through the drip chamber; and a fluid flow bypass pathway 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 pathway bypasses the drip chamber.

[0035] 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 may comprise 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 may comprise 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 may comprise a third flexible region disposed within the first bypass branch, the third flexible region enabling an inlet 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 occlude the direct flow lumen and the inlet 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 delivering fluid 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 withdraw fluid control valve may be closed to block the fluid flow bypass pathway. In at least one exemplary embodiment, when a next withdrawal of fluid is to be delivered from the donor, 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.

[0036] In at least one exemplary embodiment, the present disclosure provides a method for moving fluid through a soft cassette, the method including the steps of providing a soft cassette having 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 to the first cassette port between the first cassette port and the drip chamber and a fluid flow bypass path 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. and a fluid flow bypass pathway fluidly connected to the direct flow lumen, the method further comprising, when drawing whole blood from a donor, receiving whole blood from the cassette inlet tube at the first cassette port fluidly connected to the cassette inlet tube, moving 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, and when returning red blood cells to the donor, receiving red blood cells from the loop inlet tube at the second cassette port fluidly connected to the loop inlet tube, moving the red blood cells through the direct flow lumen and the drip chamber to the first cassette port, and preventing the red blood cells from moving through the fluid flow bypass pathway.

[0037] In at least one exemplary embodiment, when fluid is drawn from the donor on the next draw, a portion of the fluid previously delivered to the donor through the direct flow lumen may be retained in the drip chamber as whole blood passes again through the fluid flow bypass pathway when red blood cells are returned to the donor.

[0038] Any one or more of the above aspects / embodiments substantially as disclosed herein may optionally be combined with any one or more of the other aspects / embodiments substantially as disclosed herein.

[0039] One or more means adapted to carry out any one or more of said aspects / embodiments substantially as disclosed herein.

[0040] The present disclosure can provide many advantages depending on the particular aspect, embodiment, and / or configuration. By maintaining the centrifuge rotation speed while transferring unwanted blood components back to the donor, the apheresis procedure time can be reduced, in some cases by 30%. 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, with faster donor donation times, donors are more likely to return for another donor donation. With faster donor donation times, donor donation centers can also attract donors who use other donor donation centers with slower donor donation times.

[0041] The terms "at least one," "one or more," and "and / or" are open-ended expressions that are both conjunctive and disjunctive in operation. For example, the phrases "at least one of A, B, and C," "at least one of A, B, or C," "one or more of A, B, and C," "one or more of A, B, or C," and "A, B, and / or C" each mean A only, B only, C only, both A and B, both A and C, both B and C, or all of A, B, and C.

[0042] The term "a" or "an" entity refers to one or more of that entity. Thus, the terms "a" (or "an"), "one or more" (one or more), and "at least one" can be used interchangeably herein. It should also be noted that the terms "comprising," "including," and "having" can be used interchangeably.

[0043] 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.

[0044] 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."

[0045] 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.

[0046] 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 functions associated with that element.

[0047] 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.

[0048] It should be understood that the term "means" as used herein should be given its broadest possible interpretation pursuant to the sixth paragraph of 35 U.S.C. Section 112. Accordingly, any claim containing the term "means" is intended to cover all structure, material, or acts described herein, and all equivalents thereof. Furthermore, structure, material, or acts, and equivalents thereof, are intended to include everything described in the Summary, Brief Description of the Drawings, Detailed Description, Abstract, and the claims themselves.

[0049] The foregoing is a simplified summary of the present disclosure to provide an understanding of some aspects thereof. This summary is not an extensive or comprehensive overview of the present disclosure and its various aspects, embodiments, and / or configurations. It is not intended to identify key or critical elements of the disclosure, nor is it intended to delineate the scope of the disclosure; rather, it is intended to present selected concepts of the disclosure in a simplified form as a prelude to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and / or configurations of the present disclosure are possible that utilize, alone or in combination, one or more of the features described above or in more detail below. [Brief explanation of the drawings]

[0050] [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] 2B is a perspective view of an exemplary pump for use in the apheresis system of FIG. 1, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 2C] FIG. 2C is another perspective view of the exemplary pump shown in FIG. 2B. [Figure 2D]2D is a perspective view of an exemplary fluid valve control system for use in the apheresis system of FIG. 1, according to at least one exemplary embodiment of the present disclosure. [Figure 3A] 3A is a perspective view of an exemplary disposable soft cassette assembly for use in the apheresis system of FIG. 1, according to at least one exemplary embodiment of the present disclosure. [Figure 3B] FIG. 3B is another perspective view of the exemplary disposable soft cassette shown in FIG. 3A. [Figure 3C] FIG. 3C is an elevational cross-sectional view taken along line 3C of FIG. 3B. [Figure 3D] FIG. 3D is an elevational cross-sectional view taken along line 3D of FIG. 3B. [Figure 4A] 4A is a perspective view of an exemplary centrifuge assembly for use in the apheresis system of FIG. 1, 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 the centrifuge assembly of FIG. 4A in a closed state, according to at least one exemplary embodiment of the present disclosure. [Figure 4E] FIG. 4E is a schematic cross-sectional view of the centrifuge assembly of FIG. 4A in a partially open state, according to at least one exemplary embodiment of the present disclosure. [Figure 4F] FIG. 4F is a schematic cross-sectional view of the centrifuge assembly of FIG. 4A in an open state, according to at least one exemplary embodiment of the present disclosure. [Figure 4G] FIG. 4G is a perspective view of an exemplary filler for use in the centrifuge of FIG. 4A, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 4H] FIG. 4H is a plan view of the exemplary filler shown in FIG. 4G. [Figure 4I]FIG. 41 is a schematic plan view of a generally spiral-shaped receiving channel for use in the filler shown in FIG. 4G, 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 the filler shown in FIG. 4G. [Figure 4L] 4L shows different views of the fluid separation bladder disposed within the channel in the filler of FIG. 4G. [Figure 5A] FIG. 5A is a schematic diagram of an exemplary fluid component collection set for use in the exemplary apheresis system shown in FIG. 1, for example, according to an embodiment of the present disclosure. [Figure 5B] FIG. 5B is an elevational view of the fluid component collection loop of FIG. 5A. [Figure 5C] 5C is a cross-sectional view of an exemplary bladder for use in the fluid component collection loop of FIG. 5A, according to at least one exemplary embodiment of the present disclosure. [Figure 5D] FIG. 5D is a cross-sectional view of another exemplary bladder for use in the fluid component collection loop of FIG. 5A, according to at least one exemplary embodiment of the present disclosure. [Figure 5E] FIG. 5E is a perspective view of the fluid component collection loop of FIG. 5A in a bent state, according to at least one exemplary embodiment of the present disclosure. [Figure 5F] FIG. 5F is a perspective view of the fluid component collection loop of FIG. 5A in a loaded state, according to at least one exemplary embodiment of the present disclosure. [Figure 5G] 5G is a perspective view of the exemplary fluid component collection loop shown in FIG. 5A attached to the exemplary filler shown in FIG. 4G, for example, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 5H] 5H is a perspective view of the exemplary fluid component collection loop shown in FIG. 5A attached to the exemplary filler shown in FIG. 4G, for example, in accordance with at least one exemplary embodiment of the present disclosure. [Figure 6A]FIG. 6A is a schematic cross-sectional view of the centrifuge assembly of FIG. 4A 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 the centrifuge assembly of FIG. 4A in a second loop mounted state, according to at least one exemplary embodiment of the present disclosure. [Figure 6C] FIG. 6C is a schematic cross-sectional view of the centrifuge assembly of FIG. 4A in a third loop mounting state, according to at least one exemplary embodiment of the present disclosure. [Figure 7A] FIG. 7A is a schematic top view of the centrifuge assembly of FIG. 4A 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 the centrifuge assembly of FIG. 4A in an operational state, according to at least one exemplary embodiment of the present disclosure. [Figure 8] FIG. 8 is a functional diagram of the exemplary apheresis system shown in FIG. 1, 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 the apheresis system shown in FIG. 1, according to at least one exemplary embodiment of the present disclosure. [Figure 10] FIG. 10 is a further block diagram of the exemplary electrical system shown in FIG. [Figure 11] FIG. 11 is a further block diagram of the exemplary electrical system shown in FIG. [Figure 12] FIG. 12 is a process diagram of an exemplary method for performing apheresis, for example, using the apheresis system shown in FIG. 1, according to at least one exemplary embodiment of the present disclosure. [Figure 13] FIG. 13 is a process diagram of another exemplary method for performing apheresis, for example, using the apheresis system shown in FIG. 1, according to at least one exemplary embodiment of the present disclosure. [Figure 14]FIG. 14 is a process diagram of another exemplary method for performing apheresis, for example, using the apheresis system shown in FIG. 1, according to at least one exemplary embodiment of the present disclosure. [Figure 15] FIG. 15 is a process diagram of another exemplary method for performing apheresis, for example, using the apheresis system shown in FIG. 1, according to at least one exemplary embodiment of the present disclosure. [Figure 16] FIG. 16 is a process diagram of an exemplary method for inserting a disposable into a filler similar to the filler shown in FIG. 4G, according to at least one exemplary embodiment of the present disclosure. [Figure 17A] FIG. 17A is an exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17B] FIG. 17B is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17C] FIG. 17C is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17D] FIG. 17D is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17E] FIG. 17E is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17F] FIG. 17F is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17G] FIG. 17G is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17H] FIG. 17H is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17I] FIG. 17I is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17J] FIG. 17J is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17K] FIG. 17K is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17L] FIG. 17L is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17M] FIG. 17M is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17N] FIG. 17N is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17O]FIG. 17O is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17P] FIG. 17P is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17Q] FIG. 17Q is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17R] FIG. 17R is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17S] FIG. 17S is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. [Figure 17T] FIG. 17T is another exemplary functional diagram of an apheresis system similar to the apheresis system shown in FIG. 1 during an apheresis procedure, according to at least one exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0051] In the accompanying figures, similar components and / or features may have the same reference label. Furthermore, various components of the same type may be distinguished by following the reference label with a letter that distinguishes between the similar components. When only a leading reference label is used in the specification, the description can apply to any one of the similar components having the same leading reference label regardless of subsequent reference labels.

[0052] Embodiments of the present disclosure are described in the context of apheresis methods and systems. The following embodiments are described with respect 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.

[0053] 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, and / or anticoagulant tubing 110) extending from the donor 102 to the apheresis system 200 and / or vice versa. For example, the donor supply tubing 104 may be 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 (e.g., 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.

[0054] 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 may be delivered through at least anticoagulant tubing 110 and tubing connector 106 to prevent clotting of blood within apheresis system 200.

[0055] The anticoagulant may include, but is not limited to, one or more of citrate and / or unfractionated heparin. The AC bag 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 weight of the donor 102 and the volumetric flow rate of blood from the donor. In one example, the volume in the AC bag 114 is 250 mL to 500 mL, although the volume in the AC bag 114 may be greater or less than this volume.

[0056] In at least one 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 tubes 116, 120 (e.g., fluid transfer tubes) 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, for example, approximately 500 mL to 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) delivery 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 or adjacent to or in physical proximity to the very bottom 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. 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.

[0057] 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 104, 108A, 108B, 112, 116, 120 used in the extracorporeal tubing circuit form a closed, sterile, disposable system or blood component collection set, described further below.

[0058] 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).

[0059] The operation of the various pumps, valves, and blood component separation device or centrifuge may be controlled by one or more processors included in the apheresis system 200. The one or more processors may include, for example, 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, and / or flash memory), 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 / or audio system. To assist an operator of the apheresis system 200 with various aspects of its operation, embodiments of the blood component separation device or centrifuge may include a graphical user interface with a display, including an interactive touchscreen.

[0060] Apheresis system 200 may include one or more supports 232A-232C, including a housing 204 and / or structural frame, a cover 210, an access panel 224 disposed on the front 202 and / or rear 206 of apheresis system 200, and hooks, rests, cradles, arms, protrusions, plates, and / or other support features that hold, mount, and / or otherwise support bags or containers 114, 118, 122. In at least one exemplary embodiment, the functional portions of apheresis system 200 are described in relation to coordinate system 103 and / or one or more axes thereof. Housing 204 may include an apparatus frame (e.g., formed from welded, bolted, and / or connected structural elements, extrusions, and / or beams) to which one or more panels, covers 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 208, 212, 216, and / or a fluid valve control system 228 (e.g., plasma and saline valve control).

[0061] Access panel 224 may include one or more handles, locks, and pivots or hinges 226 (e.g., door hinges, piano hinges, continuous hinges, and / or clean room hinges). 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.

[0062] 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 spin 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, and / or wiring) may be provided through a rigidly fastened panel of housing 204 and / or a panel separate from access panel 224.

[0063] In at least one exemplary embodiment, apheresis system 200 includes multiple pumps 208, 212, 216 configured to control the flow of fluids (e.g., blood and / or blood components, anticoagulant, and / or saline) through apheresis system 200. For example, apheresis system 200 includes a draw pump 208 that controls blood flow to and / or from donor 102 to a centrifuge of apheresis system 200. The draw pump 208 may engage a portion of loop 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 a return pump 212 configured to control the flow of separated blood components (e.g., plasma) from the centrifuge to plasma collection bottles 122 and / or vice versa. Additionally or alternatively, return pump 212 may control the flow of saline (e.g., supplied from saline bag 118) throughout the blood component collection set and / or apheresis system 200. Anticoagulant 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 , pumps 208, 212, 216 may be at least partially disposed on top cover 210 of apheresis system 200.

[0064] 2B and 2C show various perspective views of pumps 208, 212, 216 of apheresis system 200, in accordance with at least one exemplary embodiment of the present disclosure. While draw pump 208 is shown and described in connection with FIGS. 2B and 2C, it should be understood that the other pump assemblies of apheresis system 200 (i.e., return pump 212 and anticoagulant pump 216) may include substantially similar, if not identical, configurations to the described draw pump 208.

[0065] 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 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 transferred or drawn into the donor 102 by the draw pump 208 in a donor direction 250B opposite the centrifuge direction 250A.

[0066] In at least one exemplary embodiment, the draw pump 208 and / or other pumps 212, 216 may be tube pumps, peristaltic pumps, diaphragm pumps, and / or other pumps configured to manipulate the flow of fluid (e.g., blood, blood components, anticoagulant, and / or saline) within at least a portion of the tubing. For example, the pumps 208, 212, 216 may include a motor operatively interconnected with the rotating tubing contact assembly. In operation, tubing (e.g., the loop inlet tubing 108B, the loop outlet tubing 112, and / or the anticoagulant tubing 110) may be inserted into the lead tubing guide 244, the tubing pressurizing block 248, and the end tubing guide 252 adjacent the rotating tubing contact head. In at least one exemplary embodiment, the tubing pressurizing block 248 may be moved away from the rotating tubing contact head or the pumps 208, 212, 216 to create an entrapment 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 plates 272A, 272B are configured to rotate about the pump axis of rotation 260. In at least one exemplary embodiment, the rotary pressure rollers 268 are disposed on the outer periphery of the rotary pump plates 272A, 272B.

[0067] One or more of pumps 208, 212, 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 pumps 208, 212, 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.

[0068] When the tubing 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 rotary pressure roller 268 engages, contacts, or presses against the tubing disposed between the rotary tube contact head and the tube pressurizing block 248. As the rotary pump plates 272A, 272B rotate about the pump rotation axis 260, the rotary pressure roller 268 compresses the portion of the tubing between the pumps 208, 212, 216 and the tube pressurizing block 248, ensuring that fluid within that portion of the tubing moves in the direction 250A, 250B that the rotary pressure roller 268 moves. For example, when the rotary pump plates 272A, 272B rotate counterclockwise about the pump rotation axis 260, the rotation of the rotary pressure roller 268 compressing the tubing between the rotary pressure roller 268 and the tube pressurizing block 248 can move or force fluid in the centrifuge direction 250A. As another example, when the rotating pump plates 272A, 272B rotate clockwise about the pump axis of rotation 260, the rotation of the rotating pressure roller 268 compressing the tubing between the rotating 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 maintains a state in which at least one rotating pressure roller 268 continues to occlude the tubing 108B, or a state in which the rotating pressure roller 268 does not occlude the tubing 108B. Thus, the pump 208 can also act as a "valve" to prevent or allow fluid movement based on its quiescent state. This capability is also possible with pumps 212, 216.

[0069] The tube guard 240 and pump cover 236 serve to protect the operator (e.g., the phlebotomist and / or apheresis technician) and / or donor 102 from accidental contact with one or more moving parts of the pumps 208, 212, 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 the tube guard 240, the lead tube guide 244, the tube pressurizing block 248, and / or the end tube guide 252. These guard closure features 254 may be magnets housed in the tube guard 240, the lead tube guide 244, the tube pressurizing block 248, and / or the end tube guide 252. In at least one exemplary embodiment, the pumps 208, 212, 216 may be stopped or prevented from moving / operating when the tube guard 240 is open. In at least one exemplary embodiment, a guard closure sensor may be included in the guard closure feature 254 , the guides 244 , 252 , and / or the tube pressurizing block 248 .

[0070] 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 can include a plasma-saline valve control system 228 positioned adjacent saline bag 118 and / or plasma collection bottle 122. Plasma-saline valve control system 228 is shown in a detailed perspective view in FIG. 2D.

[0071] As shown in FIG. 2D , the loop 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 allows connection of the loop outlet tubing 112 to the saline tubing 116 line and the plasma tubing 120 line. The plasma-saline valve control system 228 includes an air detection sensor 284 disposed at a first end of the saline-plasma valve housing 276 and surrounding a portion of the loop outlet tubing 112. For example, 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 loop 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.

[0072] Saline-plasma valve housing 276 includes a plurality of receiving features (e.g., grooves, channels, and / or receptacles) that receive portions of tubing 112, 116, 120 and / or saline-plasma tubing y-connector 280. Upon detecting air in loop outlet tubing 112, plasma-saline valve control system 228 selectively activates one or more of fluid control valves 286, 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.

[0073] 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 tubing 112, 116, 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 feature 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 feature of the saline-plasma valve housing 276. In either case, the control valves 286, 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 a portion of the tubing contained within the saline-plasma valve housing 276. It should be understood that although the control valves 286, 288 may completely pinch the tubing (e.g., completely restrict fluid flow through the tubing), the control valves 286, 288 may also be partially actuated to a position that partially restricts fluid flow through a portion of the tubing.

[0074] 3A illustrates an exemplary disposable soft cassette assembly 300 according to at least one exemplary embodiment of the present disclosure. The soft cassette assembly 300 includes a base plate and a cassette access door 304 attached to the base plate via at least one hinge and / or cassette access door latch 308. In at least one exemplary embodiment, the cassette access door 304 is unlocked and pivoted about a cassette access door hinge axis 306 by actuating the cassette access door latch 308. The soft cassette assembly 300 may be configured with one or more soft cassette receiving features 324 for at least partially accommodating and / or positioning a soft cassette 340 therein. The soft cassette 340 may be part of a blood component collection set described herein. For example, the soft cassette 340 may be disposed between the cassette inlet tubing 108A and the loop inlet tubing 108B of the extracorporeal tubing circuit. In at least one exemplary embodiment, the soft cassette 340 includes one or more features for controlling the flow of blood and / or blood components from the donor 102 to the apheresis system 200 and / or vice versa.

[0075] The soft cassette assembly 300 includes an air detection sensor 312, a fluid sensor 316, and one or more fluid control valves 320A-320C configured to control the path or direction of fluid flow through the soft cassette 340. In at least one exemplary embodiment, these components may be embedded in the cassette access door 304, the base plate, 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. These features 328 may include, but are not limited to, magnetic catches, protrusions, tabs and slots, and / or other connections. 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 340 within the soft cassette assembly 300.

[0076] Examples of the valves 320A-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) a fluid passageway (e.g., cross-sectional area) associated with a particular portion of the soft cassette 340. The soft cassette assembly 300 includes a first fluid control valve 320A configured to pinch a portion of the soft cassette 340 adjacent to the cassette inlet tube 108A. The second fluid control valve 320B may be configured to pinch a portion of the soft cassette 340 adjacent to the loop inlet tube 108B. The retract fluid control valve 320C may be configured to pinch a portion of the soft cassette 340 along a branch tube extending from a point adjacent to the cassette inlet tube 108A to a point adjacent to the loop inlet tube 108B. In any event, the valves 320A-320C include extendable fingers that are actuatable to move from a retracted or partially retracted position to an extended or partially extended position to pinch a portion of the soft cassette 340 housed within the soft cassette assembly 300. While the valves 320A-320C may completely pinch a flow path within the soft cassette 340 (e.g., completely restrict fluid flow through the flow path), it should be understood that the valves 320A-320C may also be partially actuated to a position that partially restricts fluid flow through a portion of the soft cassette 340.

[0077] The sensors 312, 316 may be one or more of an ultrasonic detector, a pressure sensor, a magnetic position sensor, and / or the like. The fluid sensor 316 may determine whether fluid is present in the soft cassette 340 based on the position of a magnet relative to the portion of the soft cassette 340. For example, when the portion of the soft cassette 340 is filled with fluid, the magnet is positioned at a first position from the surface of the soft cassette 340. On the other hand, when the portion of the soft cassette 340 is filled with air, a force from the magnet compresses the portion of the soft cassette 340 to a second position that is closer to the surface of the soft cassette 340 than the first position. In any case, the detection of air or fluid by the air detection sensor 312 and the fluid sensor 316, respectively, may be used to signal an operational step and / or trigger a step of a control method described herein.

[0078] 3B-3D illustrate an exemplary soft cassette 340 according to at least one exemplary embodiment of the present disclosure. As previously described, the soft cassette 340 may be part of a blood component collection set. For example, the soft cassette 340 may be a disposable component used in the blood separation methods described herein. In at least one exemplary embodiment, the soft cassette 340 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 340 may be formed from polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone, thermoplastics, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof. In at least one exemplary embodiment, the soft cassette 340 is molded, rotomolded, cast, injection molded, or otherwise formed from one or more of the aforementioned materials.

[0079] The soft cassette 340 may include a first cassette port 360A, a second cassette port 360B, and a direct flow lumen 370 extending between the first cassette port 360A and the second cassette port 360B. In at least one exemplary embodiment, the first and / or second cassette ports 360A, 360B may be configured to receive and / or fluidly couple with one or more tubings of a blood component collection set. For example, the first cassette port 360A couples with the cassette inlet tubing 108A, and the second cassette port 360B couples with the loop inlet tubing 108B. These connections are airtight and / or fluid-tight. In at least one exemplary embodiment, the first and / or second cassette ports 360A, 360B may include openings disposed within a soft cassette 340 configured to elastically stretch around the ends of the tubing (e.g., cassette inlet tube 108A and / or loop inlet tube 108B).

[0080] Blood supplied by donor 102 is directed along one or more flow paths disposed within soft cassette 340. In at least one exemplary embodiment, the blood is directed along direct flow lumen 370 from first cassette port 360A to second cassette port 360B. In at least one exemplary embodiment, this flow path directs the blood through drip chamber 354 of soft cassette 340. In at least one exemplary embodiment, blood and / or other fluids returned to donor 102 are directed along direct flow lumen 370 from second cassette port 360B to first cassette port 360A.

[0081] The soft cassette 340 includes a fluid flow bypass path provided by a first bypass branch 358A having a bypass flow lumen 364 fluidly connected to a portion of the direct flow lumen 370 adjacent to or as part of the first cassette port 360A. In at least one exemplary embodiment, the bypass flow lumen 364 extends from a point on the direct flow lumen 370 adjacent to the first cassette port 360A, along the first bypass branch 358A, through the fluid pressure annulus 362, to a second bypass branch 358B, and then reconnects to the direct flow lumen 370 at a point adjacent to or as part of the second cassette port 360B. As the name suggests, the bypass flow lumen 364 provides a flow path within the soft cassette 340 that bypasses the drip chamber 354.

[0082] Controlling the flow path or directing fluid within the soft cassette 340 involves actuating the fluid control valves 320A-320C of the soft cassette assembly 300 to cause the valves to interact with various flexible regions 350A-350C to block and / or open portions of the direct flow lumen 370 and / or the bypass flow lumen 364. The first flexible region 350A provides a pinch valve region at a point along the direct flow lumen 370 between the first cassette port 360A and the drip chamber 354 near the first cassette end 342 of the soft cassette 340. When the first fluid control valve 320A is actuated, the valve 320A pinches the direct flow lumen 370 with the first flexible region 350A, thereby restricting or completely preventing fluid flow at this point within the soft cassette 340. The second flexible region 350B provides a pinch valve region at a point along the direct flow lumen 370 between the second cassette port 360B near the second cassette end 346 (e.g., the end opposite the first cassette end 342) and the drip chamber 354. When the second fluid control valve 320B is actuated, the valve 320B pinches the direct flow lumen 370 with the second flexible region 350B, thereby restricting or completely preventing fluid flow at this point within the soft cassette 340. As can be appreciated, the third flexible region 350C, located along the first bypass branch 358A adjacent the fluid pressure ring 362, can provide a pinch valve region at a point along the bypass flow lumen 364. When the retraction fluid control valve 320C is actuated, the valve 320C can pinch the bypass flow lumen 364 with this third flexible region 350C, thereby restricting or completely preventing fluid flow through the bypass flow lumen 364.

[0083] 3C taken along a plane extending through direct flow lumen 370 and drip chamber 354, direct flow lumen 370 extends from first cassette port 360A through the interior chamber volume 374 of drip chamber 354 to second cassette port 360B. Direct flow lumen 370 is formed as a flow path extending inside first tubing section 368A, interior chamber volume 374, and second tubing section 368B of soft cassette 340.

[0084] In at least one exemplary embodiment, the bypass path of the soft cassette 340 includes a fluid pressure ring 362 through which fluid can flow from the first bypass branch 358A to the second bypass branch 358B and / or vice versa. In at least one exemplary embodiment, a pressure diaphragm 380 may be formed in the material of the soft cassette 340 within or adjacent to the fluid pressure ring 362. The fluid pressure ring 362 and pressure diaphragm 380 are shown in the elevational cross-sectional view of FIG. 3D taken along a plane extending through the fluid pressure ring 362 and portions of the first and second bypass branches 358A, 358B. The pressure diaphragm 380 may provide a contact or measurement surface for a fluid sensor 316 to detect whether the fluid pressure ring 362 and / or the bypass flow lumen 364 contain a predetermined amount of fluid, air, and / or a combination thereof. As previously mentioned, when fluid fills a portion of the annulus 362, the fluid can offer a greater resistance to movement than when the annulus 362 is filled with air. This difference in resistance is measured by the fluid sensor 316, thereby determining the amount and type of fluid (e.g., air and / or blood) in the bypass flow lumen 364 and / or the annulus 362.

[0085] 4A-4C illustrate an exemplary centrifuge assembly 400 for use in the 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 202 of the apheresis system 200. For example, the access panel 224 in FIG. 4A is shown in an open position, opened along a hinge axis 226. As previously described, the hinge axis 226 may correspond to a door hinge, a continuous hinge, a clean room hinge, and / or some other panel hinge.

[0086] 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. The centrifuge assembly 400 is loaded with one or more portions of a blood component collection set by routing tubing (e.g., loop inlet tubing 108B and / or loop outlet tubing 112) into the interior space of the apheresis system 200 (e.g., through opening 220 shown in FIG. 2A ), connecting a portion of the blood component collection loop 520 to the fixed loop connector 402, and inserting the blood component separation bladder 536 into the filler 460. The fixed loop connector 402 maintains the loop inlet tubing 108B and loop 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.

[0087] The centrifuge assembly 400 includes a centrifuge split housing 404 comprising 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 separation bladder or other components of a blood component collection set 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, and / or shoulder bolt).

[0088] 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 (as shown in FIG. 4C). When the upper housing 404B is in the unlocked position, it can be opened or pivoted about the split housing pivot axis 406 to load the blood component collection loop 520 and / or blood component separation bladder 536 into the centrifuge assembly 400. When the upper housing 404B is in the locked position, it is rotationally locked relative to the lower housing 404A, and the two halves of the centrifuge split housing 404 are locked together and rotate as a unit during centrifugation or blood separation operations.

[0089] 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.

[0090] 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.

[0091] 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.

[0092] 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 rotation axis 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).

[0093] The centrifuge assembly 400 may include one or more balancing features, elements, and / or structures disposed about the centrifuge axis of rotation 430 of the centrifuge assembly 400. These balancing features may axially balance the centrifuge assembly 400 so that it is substantially vibration-free with respect to the apheresis system 200 when rotated about the centrifuge axis of rotation 430. In at least one exemplary embodiment, a centrifuge balance weight 418 is attached to a portion of the centrifuge split housing 404 (e.g., the lower housing 404A and / or the upper housing 404B). This centrifuge balance weight 418 may be custom-tuned for the centrifuge assembly 400 and, therefore, may be selectively attached to and detached from the centrifuge assembly 400. The adjustment of the centrifuge balance weight 418 is calculated and / or experimentally derived to result in a perfectly balanced centrifuge assembly 400, particularly when equipped with one or more elements of a blood component collection set.

[0094] 4C is a rear perspective view of centrifuge assembly 400. 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, where a first end is interconnected with filler 460 and a second end is 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, 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 allow 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 constraining or twisting the flexible loop 524, is sometimes referred to herein as twisting. This twist 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.

[0095] 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.

[0096] 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.

[0097] 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.

[0098] FIG. 4D shows the centrifuge assembly 400 in a closed state (e.g., before attachment of the blood component collection loop 520). 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 about the split housing pivot axis 406 in the opening direction 446 shown in FIG. 4E. 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.

[0099] 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, when the upper housing 404B is in the open position, the interior of the upper housing 404B and the filler 460 can be easily accessed. 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 .

[0100] FIG. 4G illustrates, for example, a filler 460 of the centrifuge assembly 400. In at least one exemplary embodiment, the filler 460 is formed from a lightweight material, such as plastic, carbon fiber, and / or aluminum. 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.

[0101] 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 in 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.

[0102] In at least one exemplary embodiment, the filler 460 includes a separation insert channel 466 configured to receive and at least partially accommodate a blood component separation bladder of a blood component collection set, more specifically, a blood component collection loop 520. The separation 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 separation insert channel 466 follows a generally spiral-shaped path including a first spiral path portion extending outward along the circumferential length of the separation 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 separation 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 separation 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 insert channel 466's spacing from the center of the filler body 464, thereby increasing centripetal and centrifugal forces at the channel end 472 of the separation 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 separation bladder 536 that is at least partially inserted or disposed within the separation 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 separation insert channel 466 contains a blood component separation bladder and fluid (e.g., blood, blood components).

[0103] FIG. 4I illustrates a generally helical receiving or separation insert channel 466 in a filler 460. This schematic plan view illustrates a first distance R1 of the separation 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 from the center of the filler body 464 at a portion of the separation insert channel 466 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 end of the blood component separation bladder is generally coincident with the channel end 472, thereby providing the greatest blood separation force at the end of the bladder.

[0104] 4J-4L show various elevational cross-sectional views of the filler 460, and more specifically, the separation insert channel 466 and filler insert chamber 492 disposed inside the filler body 464. In at least one exemplary embodiment, the separation insert channel 466 has a cross-section or shape that generally follows a generally spiral path 490 within the filler body 464. The separation insert channel 466 includes an insert groove configured to receive a generally flat or unfilled blood component separation bladder. The blood component separation bladder is inserted within the separation insert channel 466 and into a filler insert chamber 492 formed within the filler body 464 along the generally spiral path 490. The filler insert chamber 492 is defined by one or more sidewalls 494, 496 that form a cavity that follows the generally spiral path 490. 4K , the filler insertion chamber 492 includes an inner chamber wall 494 spaced a given distance from at least one outer chamber wall 496. The filler insertion 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, and / or molding). In at least one exemplary embodiment, the filler insertion 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 separation bladder inside the filler insertion 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 separation bladder.

[0105] 4L illustrates different states of a fluid separation bladder (e.g., a blood component separation bladder) disposed within the separation insert channel 466 and filler insert chamber 492 of the filler 460. As previously described, the blood component separation bladder is inserted into the separation insert channel 466 in a substantially flat, or unfilled, state S1. In the substantially flat state S1, the blood component separation bladder is sized to fit into the upper opening of the separation 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 blood provided by the donor 102, the blood component separation bladder expands from the substantially flat, first state S1 to an expanded, or filled state S2. In at least one exemplary embodiment, the blood component separation bladder can be expanded with blood and / or blood components until the walls of the blood component separation 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).

[0106] 5A illustrates a blood component collection set 500 according to at least one exemplary embodiment of the present disclosure. The blood component collection set 500 includes tubing (e.g., one or more of donor supply tubing 104, cassette inlet tubing 108A, loop inlet tubing 108B, anticoagulant tubing 110, loop outlet tubing 112, saline tubing 116, and / or plasma tubing 120), connectors (e.g., one or more of tubing connector 106, saline-plasma tubing y-connector 280, tubing fitting 504, tubing fitting 508, and / or bag spike fitting 512), a soft cassette 340, and a blood component collection loop 520.

[0107] The tubing is any tubing having a central lumen configured to carry a fluid. The tubing can be formed from polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), rubber, polymers, copolymers, and / or combinations thereof. The connector is configured to fluidly interconnect with the tubing (e.g., at one or more ends of the tubing). The connector may be inserted into the central lumen of the tubing and / or attached to the exterior surface of the tubing. In at least one embodiment, the connector may be configured with a variety of fittings (e.g., luer fittings, twist connections, and / or other stoma couplings) to provide a universal and / or reliable interconnection to one or more other fittings, connectors, tubing, needles, and / or medical accessories. In at least one embodiment, the bag spike fitting 512 may be configured for insertion into a receiving bag (e.g., saline bag 118).

[0108] The blood component collection loop 520 includes a flexible loop 524 disposed between a system securement loop connector 528 and a filler loop connector 532. 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 embodiment, the flexible loop 524 may be formed from a highly flexible thermoplastic elastomer capable of transmitting torsion from one end of the flexible loop 524 to the other. These types of elastomers can provide the flexibility of rubber while maintaining the strength and torque characteristics of plastic. Examples of thermoplastic elastomers may include, but are not limited to, copolyesters, DuPont™ Hytrel® thermoplastic elastomers, Eastman Neostar™ elastomers, Celanese Riteflex® elastomers, TOYOBO PELPRENE®, and / or elastomers from other manufacturers that provide high flexibility and strength characteristics.

[0109] In at least one embodiment, blood component collection loop 520 includes a blood component separation bladder 536 having a bladder loop end 540A and a bladder free end 540B. Blood component separation bladder 536 includes a first collection flow chamber 544 connected to flexible loop 524 with a filler loop connector 532. In particular, fluid can flow between loop inlet tube 108B and first collection flow chamber 544, and / or vice versa, via flexible loop 524 and connectors 528, 532. Fluid flowing from bladder loop end 540A along first collection flow chamber 544 toward bladder free end 540B can reach flow chamber transition 548 and enter second collection flow chamber 552. In at least one embodiment, second collection flow chamber 552 is interconnected to flexible loop 524 with filler loop connector 532. In particular, fluid can flow between the loop outlet tube 112 and the second collection flow chamber 552 via the flexible loop 524 and connectors 528, 532, and / or vice versa.

[0110] Details of blood component collection loop 520 are described in connection with the elevational view of FIG. 5B . Blood component collection loop 520 includes a flexible loop 524 configured as tubing with a first pathway for loop inlet tubing 108B and a second pathway for loop outlet tubing 112. In at least one embodiment, loop inlet tubing 108B passes through flexible loop 524 and interconnects with a first collection flow chamber 544 at a bladder loop end 540A via a filler loop connector 532. Additionally or alternatively, loop outlet tubing 112 may pass through flexible loop 524 and interconnect with a second collection flow chamber 552 at a bladder loop end 540A via a filler loop connector 532. The first pathway is separate from the second pathway. This configuration allows blood to pass through first collection flow chamber 544, enter flexible loop 524, and enter blood component separation bladder 536 to be separated into one or more blood components. The blood components are then transported along second collection flow chamber 552 to loop outlet tubing 112 within flexible loop 524 .

[0111] The first collection flow chamber 544 is separated from the second collection flow chamber 552 via a flow chamber separator 542. The flow chamber separator 542 may be a heat-sealed portion of the blood component separation bladder 536. For example, the blood component separation bladder 536 may be formed from overlapping layers of material along the length of the blood component separation bladder 536. The layers of material may be shaped (e.g., cut or molded) and heat-sealed along one or more edges to form the fluid container. The flow chamber separator 542 may be formed within the fluid container by heat-sealing one layer of material to another layer of material along a path, as illustrated. The flow chamber separator 542 does not extend the entire length of the blood component separation bladder 536, but rather provides a flow chamber transition 548 for fluid (e.g., blood, blood components) to pass from the first collection flow chamber 544 to the second collection flow chamber 552 and / or vice versa. In at least one exemplary embodiment, fluid (blood and / or blood components) in the blood component separation bladder 536 contained within the filler insert chamber 492 of the filler 460 can travel along the first collection flow chamber 544 toward the bladder free end 540B, around the end of the flow chamber separator 542 (e.g., following the blood component travel direction 546) to the second collection flow chamber 552. In this example, the blood components (e.g., plasma) travel along the generally spiral path 490 back along the second collection flow chamber 552 toward the center of the filler body 464 and through the loop outlet tubing 112 (e.g., toward the plasma collection bottle 122).

[0112] The blood component separation bladder 536 may be formed from polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), thermoplastics, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof. In at least one embodiment, the blood component separation bladder 536 may be formed from multiple layers of material and heat sealed, or may be formed from a single layer of material folded over itself, and / or combinations thereof.

[0113] In at least one embodiment, blood component collection loop 520 may include a number of positive positioning or key features 530A, 530B configured to positively position multiple locations of blood component collection loop 520 relative to apheresis system 200 and / or filler 460. For example, blood component collection loop 520 includes a first connector positioning feature 530A on system securement loop connector 528 and a second connector positioning feature 530B on filler loop connector 532. Features 530A, 530B may be configured as keys, tabs, and / or other protrusions of material extending from connectors 528, 532. In at least one exemplary embodiment, second connector positioning feature 530B may include features that interconnect or mate with first positive positioning feature 478 and / or second positive positioning feature 480 of loop connection region 454 of filler 460. Similar, if not identical, positive positioning features may be associated with or included in fixed loop connection 402 of apheresis system 200.

[0114] 5C and 5D show a cross section of the blood component separation bladder 536 of the blood component collection loop 520. For example, the cross section shows that the first collection flow chamber 544 is separated from the second collection flow chamber 552 along the length of the blood component separation bladder 536. In at least one embodiment, this separation may be provided by a flow chamber separator 542 disposed between the first collection flow chamber 544 and the second collection flow chamber 552. The flow chamber separator 542 may correspond to a sealed region of the blood component separation bladder 536. The flow chamber separator 542 may be formed, for example, as a heat-sealed region of material joining the bladder first side material 536A and the bladder second side material 536B. In some cases, the bladder first side material 536A and the bladder second side material 536B may be a single piece of material that is folded and overlapped at an edge (e.g., adjacent one of the upper bladder seal area 554A or the lower bladder seal area 554B).

[0115] The cross-section shown in FIG. 5D corresponds to the blood component separation bladder 536 before sealing, and the cross-section shown in FIG. 5C corresponds to the blood component separation bladder 536 after the upper bladder seal 554A, the lower bladder seal 554B, and / or the flow chamber separator 542 have been formed or sealed (e.g., by welding the bladder first side material 536A to the bladder second side material 536B). Once formed, the bladder width WB may correspond to the width of the first and / or second collect flow chambers 544 and 552 in the unexpanded state S1 (see, e.g., FIG. 4L). During operation, as fluid fills at least a portion of the blood component separation bladder 536, the bladder width WB may increase in size from the dimension shown in FIG. 5C. For example, the bladder width WB may increase substantially to the size of the filler insertion chamber 492 of the filler 460. In at least one exemplary embodiment, the welds formed (e.g., RF and / or ultrasonic) during manufacturing of blood component separation bladder 536 may be supported by filler 460. In at least one exemplary embodiment, the upper end of filler 460 supports the upper two welds, and the lower end of filler 460 supports the lower weld.

[0116] 5E-5H show various perspective views of the bent state of the blood component collection loop 520 (e.g., FIGS. 5E-5F), as well as views of the bent blood component separation bladder 536 of the blood component collection loop 520 inserted into the filler 460 (e.g., FIGS. 5G-5H). Various components of the blood component collection loop 520 may be flexible and / or may be shaped or molded 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 the blood component collection loop 520 are shaped. FIG. 5E shows the blood component collection loop 520 in a bent state. For example, the flexible loop 524 is shown bent elastically along its length, and the blood component separation bladder 536 is shown following multiple bends or curves along its length. The flexible loop 524 conveys fluid supplied via the loop inlet tube 108B to the first collection flow chamber 544 of the blood component separation bladder 536, and vice versa, while the components are in the flexed state. Additionally or alternatively, the flexible loop 524 may convey fluid from the second collection flow chamber 552 of the blood component separation bladder 536 to the loop outlet tube 112, and vice versa, while the components are in the flexed state.

[0117] In at least one exemplary embodiment, the blood component collection loop 520 may be pre-shaped to fit within the separation insertion channel 466 of the filler 460, as shown in FIG. 5F , for example. This pre-shaping may include bending the blood component separation bladder 536 of the blood component collection loop 520 to match the generally helical path 490 of the separation insertion 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 . 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, blood component separation bladder 536 may be shaped or trimmed (e.g., by hand) to conform to the generally spiral path 490 of separation insert channel 466 in filler 460. In some cases, this shaping or trimming may include aligning free bladder end 540B of blood component separation bladder 536 with channel end 472 of separation insert channel 466 in filler 460. When the components are roughly aligned with one another, blood component collection loop 520 may be moved in a direction toward separation insert channel 466 and loop connection region 454 (as shown in FIG. 5G ).

[0118] 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 when 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 some cases, 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 illustrates a blood component collection loop 520 loaded within a filler 460 in accordance with at least one exemplary embodiment of the present disclosure.

[0119] 6A-6C illustrate a centrifuge assembly 400 in various loop mounting states according to an embodiment of the present disclosure. The centrifuge assembly 400 illustrated in FIGS. 6A-6C corresponds to the centrifuge assembly 400 described above, particularly in connection with FIGS. 4D-4F. In particular, FIG. 6A illustrates a schematic cross-sectional view of a first loop mounting state, FIG. 6B illustrates a schematic cross-sectional view of a second loop mounting state, and FIG. 6C illustrates a schematic cross-sectional view of the second loop mounting state for the centrifuge assembly 400.

[0120] 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.

[0121] 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.

[0122] 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 .

[0123] 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.

[0124] 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 disposed at some 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.

[0125] 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 uncatched-loop state 700A to the captured-loop state 700B shown in FIG. 7B. This rotation may be performed 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 is rotated 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.

[0126] 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 is rotationally secured to the fixed loop connection 402 via a first connector positioning feature 530A of the 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 is interconnected at a loop connection region 454 of the filler 460 such that this end can 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.

[0127] 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.

[0128] An exemplary functional diagram of an apheresis system 200 is shown in Figure 8. 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.

[0129] 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.

[0130] 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.

[0131] 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 divides tube 358 into first bypass branch 358A and second bypass branch 358B. Similarly, tube 368 is divided in two by drip chamber 354, which divides tube 368 into first tube section 368A and second tube section 368B.

[0132] First tubing section 368A can include first fluid control valve 320A. Second tubing section 368B can include second fluid control valve 320B. First bypass branch 358A can include draw 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.

[0133] The drip chamber 354 is disposed between the first tubing section 368A and the second tubing section 368B. The drip chamber 354 is capable of collecting 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. The fluid sensor 316 is disposed between the first bypass branch 358A and the second bypass branch 358B, as previously described.

[0134] The loop inlet tube 108B is connected to the second cassette port 360B, connecting the soft cassette 340 to the flexible loop 524. The loop inlet tube 108B may also include a sensor 808 disposed on or within the tube 108B, which is disposed with the tube 108B prior to connection with the system secure loop connector 528 of the flexible loop 524. The pressure sensor (CPS) 808 may detect one or more of, but is not limited to, the pressure, presence or absence of fluid or air within the tube 108B, and / or other properties of the fluid, as the case may be. Additionally, the draw pump 208 may pump fluid through the tube 108B away from or toward the soft cassette 340.

[0135] 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 separation bladder 536. A loop outlet tube 112 exits the flexible loop 524 through the system fixation loop connector 528. This loop outlet tube 112 can also include another line sensor 812 disposed on or within the loop 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 can be the same or similar in type and / or function to the sensors 804, 312, 320, 808, and / or sensor 284 previously described. A second CPS sensor 816 or fluid sensor can 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. Sensor 816 may be the same or similar in type and / or function to sensors 804, 312, 320, 808, 812 and / or sensor 284 previously described.

[0136] The loop outlet tubing 112 may pass through a plasma air detection sensor 284 before a saline-plasma tubing y-connector 280 separates the tubing 112 into saline tubing 116 and plasma tubing 120. A return pump 212 interfaces with the loop outlet tubing 112. The return pump allows fluid or air to flow through the tubing 112 from the flexible loop 524 or from the saline bag 118 and / or plasma collection bottle 122.

[0137] The saline bag 118 and associated tubing, as previously described, can supply saline to the donor 102 through the system 200. A saline flow control valve 288 can isolate the saline bag 118 from the rest of the system 200. Additionally, the plasma collection bottle 122 can receive plasma from the flexible loop 524 as it is processed or separated from the whole blood. The plasma collection bottle 122 can be selectively isolated from the system by the plasma flow control valve 286.

[0138] 9 illustrates an exemplary electrical and control system 900 that controls the functions of apheresis system 200. Control system 900 can include one or more nodes, which can include various hardware, firmware, and / or software configured to control and / or communicate with the mechanical, electromechanical, and electrical components of apheresis system 200.

[0139] 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 and a centrifuge node 908 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 at least one exemplary embodiment, the separate nodes 904, 908 may be two portions of a single node 902. Thus, each node 904, 908 may have the same physical hardware that operates to control different functions. An example of the cassette node 904 may be described in conjunction with FIG. 10, and the centrifuge node 908 may be described in conjunction with FIG. 11.

[0140] Each of the nodes 904, 908 may be in communication with one or more sensors 916, 920 and / or 924. As represented by the ellipsis 928, there may be more or fewer sensors than those shown in FIG. 9 . Each node 904, 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 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, and / or pressure. Some of the sensors 916-924 may include sensors 312, 316, 804, 808, 812, 816 and / or sensor 284. The functions of these sensors 912-924 may be as described below.

[0141] Nodes 904, 908 may communicate with one or more pump drives, pump motors 936, 940, 944, referred to simply as "pumps." As represented by ellipsis 948, there may be more or fewer pumps than shown in FIG. 9. Nodes 904, 908 may communicate with pumps 936-944 via direct wired or wireless communication or via bus 932. Bus 932 may be a control area network (CAN) bus, USB, or other type of bus architecture for communicating with pumps 936-944. Pumps 936-944 may include pumps 216, 208 and / or pump 212, as previously described. The functionality of pumps 936-944 is described herein.

[0142] 10 illustrates an exemplary cassette node 904. Cassette node 904 may include a controller 1004, 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.

[0143] The controller 1004 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 manage the functions of other types of devices, such as valves 320A, 320B, 320C, 286, 288, and 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.

[0144] 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.

[0145] 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.

[0146] The controller 1004 can be in communication with one or more valve controllers 1020. Each of the valves 320A, 320B, 320C, 286, 288 described herein can be controlled by the valve controller 1020 and associated with components of the system 200, as described herein. The valve controller 1020 can provide electrical signals, operating commands, or power to close or open any one of the valves described herein, such as the saline-plasma valve housing 276, the plasma flow control valve 286, the saline flow control valve 288, the first fluid control valve 320A, the second fluid control valve 320B, and / or the draw fluid control valve 320C.

[0147] The controller 1004 may also be connected to the buses 912, 932 (e.g., a UART bus and / or a 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.

[0148] 11 illustrates an exemplary centrifuge node 908. The centrifuge node 908 can include the same or similar types of components as the cassette node 904. For example, the centrifuge node 908 can include a controller 1104 and / or a UART transceiver 1112. Like the controller 1004, the controller 1104 can 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 (e.g., devices previously mentioned).

[0149] 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. The motor transceiver 1116 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.

[0150] In at least one exemplary embodiment, controller 1104 can communicate with cuff controller 1122, which can change or set the pressure in a pressure cuff on the donor's arm during the apheresis process. Additionally, controller 1104 can communicate with and / or control strobe 1112, which, as previously described, is an optional light that flashes periodically in synchronization with the rotational speed of the motor so that an operator of apheresis system 200 can view the operation of filler 460. Thus, controller 1104 communicates with strobe 1112 to change the frequency of the flashing light of strobe 1112, the intensity of the light of strobe 1112, etc.

[0151] FIG. 12 illustrates an exemplary method 1200 used to perform blood component (e.g., plasma) apheresis using system 200, in accordance with at least one exemplary embodiment of the present disclosure. Method 1200 may be described in conjunction with FIGS. 17A-17T. Accordingly, method 1200 will be described with respect to or with reference to these figures. FIG. 12 illustrates a general sequence of steps in method 1200. Generally, method 1200 begins with start step 1204 and ends with step 1220. Method 1200 may include more or fewer steps, or the steps may be ordered differently than shown in FIG. 12. Method 1200 may be implemented, at least in part, as a set of computer-executable instructions executed by a computer system, a processor, cassette microcontroller 1004, centrifuge microcontroller 1104, and / or other device. The set of instructions may be encoded or stored on a computer-readable medium. In at least one exemplary embodiment, method 1200 may be performed, at least in part, by a series of components, circuits, and / or gates fabricated in a hardware device, such as a system-on-chip (SOC), an application-specific integrated circuit (ASIC), and / or a field-programmable gate array (FPGA). Method 1200 will be described below with reference to, for example, the systems, apparatus, valves, pumps, sensors, components, circuits, modules, software, data structures, signaling processes, models, environments, and / or apheresis systems described in connection with FIGS. 1-11.

[0152] Generally, method 1200 can be divided into three phases, with each phase including a series of steps or processes. Each of the three phases is depicted in FIG. 12 and will be described with reference to FIGS. 13-16, which illustrate the steps or processes. Method 1200 includes a system preparation phase in step 1208. In this phase 1208, an operator can prepare system 200 for apheresis, which may include inserting a needle into donor 102, performing other operations to prepare for blood collection, and inserting a blood component collection set 500 into the system. Examples of steps that may be included in system preparation phase 1208 are described with reference to FIG. 13.

[0153] Method 1200 enters a plasma draw phase at step 1212. Plasma draw phase 1212 is described with reference to FIG. 14. Plasma draw phase 1212 may include drawing blood, centrifuging the blood to extract plasma (and / or other blood components), and pushing high hematocrit blood (e.g., red blood cells) and / or other blood components back to donor 102 in various return cycles (until the entire sample of plasma and / or other blood components has been collected). Initiation of a return cycle may be triggered based on the presence of one or more blood components (e.g., platelets and / or red blood cells) at any predetermined location within the apheresis system.

[0154] The final stage of method 1200 is a disposables removal stage in step 1216. Disposables removal stage 1216 is described with reference to Figure 15. Disposables removal stage 1216 may include completing the apheresis process, removing the needle from the donor 102, removing the blood component collection set 500, and completing the procedure. Each of the three stages 1208-1216 and the steps or processes associated with these stages will now be described below.

[0155] FIG. 13 illustrates an exemplary method for preparing an apheresis system 200, as described in step 1208, according to at least one exemplary embodiment of the present disclosure. Method 1300 begins with start step 1304 and ends with step 1328. Method 1300 may include more or fewer steps, or the steps may be ordered differently than shown in FIG. 13. Method 1300 may be implemented, at least in part, as a set of computer-executable instructions executed by a computer system, a processor, cassette microcontroller 1004, centrifuge microcontroller 1104, and / or other device. The set of instructions may be encoded or stored on a computer-readable medium. In at least one exemplary embodiment, method 1300 may be implemented, at least in part, by a series of components, circuits, and / or gates fabricated in a hardware device, such as a SOC, an ASIC, and / or an FPGA. Method 1300 will be described below in relation to, for example, the systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signaling processes, models, environments, apheresis systems, and / or methods described in relation to Figures 1-12.

[0156] The user or operator loads the blood component collection set 500 in step 1308. In step 1308, the user loads the blood component collection set 500 into the system 200. This step includes inserting the flexible loop 524 into the loop storage bracket 426 and inserting the blood component separation bladder 536 into the filler 460 (both of which are illustrated in FIG. 16 ). Additionally, a soft cassette 340 may be loaded into the soft cassette assembly 300 as illustrated in FIGS. 1 , 2A, 2B, 3A, and / or 3B. The loop inlet tubing 108B is inserted into the lead tubing guide 244 and / or end tubing guide 252 to the draw pump 208 to initiate fluid movement in the loop inlet tubing 108B and other portions of the blood component collection set 500. Similarly, the anticoagulant tubing 110 is placed in tubing guides similar to guides 244, 252 so that the AC pump 216 can move anticoagulant to the anticoagulant tubing 110 or other portions of the blood component collection set 500. The loop outlet tubing 112 is inserted into similar guides 244, 252 so that the return pump 212 can move blood components (e.g., plasma) to the plasma collection bottle 122 or move saline from the saline bag 118 to the loop outlet tubing 112 or other portions of the blood component collection set 500.

[0157] As shown in FIG. 2D , the saline-to-plasma tubing y-connector 280 is attached to the plasma-to-saline valve control system 228, allowing valves 286, 288 to control fluid flow to and from the plasma collection bottle 122 and / or the saline bag 118. As shown in FIGS. 1-2B , the AC bag 114 is attached to the anticoagulant support 232A, the plasma collection bottle 122 is placed in the plasma collection cradle 232C, and the saline bag 118 is attached to the saline support 232B. With the blood component collection set 500 attached to the apheresis system 200, the apheresis system 200 appears as shown in FIGS. 17A and 17B . The states of the various components of the apheresis system 200 during this step are as follows:

[0158] [Table 1]

[0159] As shown in the above and subsequent tables, the draw pump 208 and return pump 212 can occlude the loop inlet tubing 108B and the anticoagulant tubing 110, respectively. In this manner, the draw pump 208 and return pump 212 function as "valves" that selectively allow or disallow fluid flow. A minus sign "-" in the "Flow Rate" column indicates that the pump is operating counterclockwise. The abbreviation "AF" stands for "Auto Flow Rate" and indicates that the pump is functioning at the flow rate of blood coming from the donor 102. The AF flow rate prevents the apheresis system 200 from drawing blood from the donor 102 or from backflowing blood back into the donor 102, and / or optimizes the draw and return flow rates while improving donor safety.

[0160] In step 1312, the saline bag 118 is spiked. The user removes any safety cover from the bag spike fitting 512 at the distal end of the saline tubing 116 and punctures the saline bag 118 containing saline. In at least one exemplary embodiment, the saline tubing 116 may be mechanically attached to the saline bag 118 (e.g., by a Luer connector), and a breakable device or other removable barrier may be partially deformed by the user to allow saline to flow from the saline bag 118. Thus, spiking the saline bag 118 allows saline to flow into or through the saline flow control valve 288 and into the blood component collection set 500. The states of various components of the apheresis system 200 during this step are as shown below:

[0161] [Table 2]

[0162] In step 1316, saline 1712 is primed. Priming saline 1712 involves the cassette microcontroller 1004 directing the opening of the saline flow control valve 288, as shown in FIG. 17D. The cassette microcontroller 1004 receives instructions or a program for the user interface to begin the apheresis process, beginning by priming saline 1712. This moves saline 1712 from the saline bag 118, through the saline flow control valve 288, and to the plasma-air detection sensor 284. The cassette microcontroller 1004 directs the counterclockwise rotation of the return pump 212 to cause a volumetric flow of saline 1712 from the saline bag 118, through the saline tubing 116 and the saline-plasma tubing y-connector 280 attached to the plasma-saline valve control system 228, and to the plasma-air detection sensor 284. When plasma-air detection sensor 284 detects either the presence of liquid or the absence of air in loop outlet tubing 112, a signal is sent to cassette microcontroller 1004. Cassette microcontroller 1004 instructs return pump 212 to stop rotating and instructs saline flow control valve 288 to close, thereby preventing saline 1712 from passing past plasma-air detection sensor 284 and further into loop outlet tubing 112. At this point in the process, the apheresis system appears as shown in FIG. 17E. The states of various components of apheresis system 200 during this step are as follows:

[0163] [Table 3]

[0164] It should be noted that the return pump 212 is described as operating in a counterclockwise direction. This direction of rotation is related to the position of the return pump 212 relative to the loop outlet tubing 112. If the return pump 212 is mounted with the loop outlet tubing 112 below the return pump 212, the return pump 212 will rotate in a clockwise direction to move the saline 1712 from the saline bag 118. Thus, throughout this description, directions of pump rotation are described with respect to the return pump 212, the draw pump 208, and / or the AC pump 216, but these directions of rotation may be different if the pumps 208, 212, 216 are mounted or positioned differently. Additionally, other types of pumps may be used, which may change the way the pumps operate to move various liquids or air within the system 200. One of ordinary skill in the art will understand how to make these modifications to achieve similar results as described in the processes and steps that follow.

[0165] Additionally, transfer volumes and transfer rates within apheresis system 200 are referenced or described in tables included herein. However, these volumes and rates depend on the size of the tubing, the size of the bag used, the desired amount of blood component collected (e.g., 880 mL of plasma), and other considerations. State or national laws and other mandates may dictate the volumes and rates used in apheresis system 200, or these transfer volumes and transfer rates may be predetermined based on the direction of a medical professional or the characteristics of donor 102. Therefore, the transfer volumes and transfer rates are exemplary only, and one of ordinary skill in the art will understand what transfer volumes and transfer rates should be for the following steps and processes.

[0166] Next, in step 1320, anticoagulant (AC) 1702 is spiked. Spike-in of anticoagulant 1702 is a process similar to spike-in of saline 1712. For example, a user attaches tubing fitting 508 to AC bag 114. The user breaks a breakable member, opens a valve or other device, or deforms some structure to allow AC 1702 to flow into anticoagulant tubing 110. In at least one exemplary embodiment, a user may insert a needle into AC bag 114. At this point in the process, apheresis system 200 appears as shown in FIG. 17E. The cassette microcontroller 1004 may be signaled by the user via a user interface or other user input device that the AC bag 114 has been connected or spiked. The states of various components of apheresis system 200 during this step are as shown below:

[0167] [Table 4]

[0168] In response to a signal from the user, the cassette microcontroller 1004 primes the AC 1702 in step 1324. To prime the AC 1702, the cassette microcontroller 1004 instructs the AC pump 216 to operate or rotate in a clockwise direction to pump anticoagulant 1702 from the AC bag 114 into the anticoagulant tubing 110, as shown in FIGURES 17F and 17G. The donor supply tubing 104 is blocked by a clamp, breakable device, or other structure. Therefore, AC 1702 does not flow from the donor supply tubing 104 to the donor 102. The AC pump 216 forces the anticoagulant 1702 into the cassette inlet tubing 108A, into the soft cassette 340, and partially into the loop inlet tubing 108B. In at least one exemplary embodiment, AC1702 flows through first bypass branch 358A, second bypass branch 358B, and / or fluid sensor 316, but not necessarily into first tubing section 368A or second tubing section 368B. Accordingly, cassette microcontroller 1004 can close first fluid control valve 320A to prevent AC1702 from flowing into first tubing section 368A, drip chamber 354, or second tubing section 368B. Pre-positioning AC1702 into first bypass branch 358A, second bypass branch 358B, and / or fluid sensor 316 ensures proper flow of whole blood during the initial draw of whole blood from donor 102 and also prevents a large amount of AC1702 from being returned to donor 102 from drip chamber 354 when red blood cells are returned later in the process.

[0169] To determine when to stop the AC pump 216, the cassette microcontroller 1004 receives signals from the fluid sensor 316 and / or the donor air detection sensor 312 indicating that fluid is present at or passing through the sensors 312, 316. Once the fluid sensor 316 notifies the cassette microcontroller 1004 that AC1702 has reached the sensor 316, the cassette microcontroller 1004 continues to direct the AC pump 216 for a predetermined period of time until a known amount of AC1702 has been delivered through the second cassette port 360B into a portion of the loop inlet tubing 108B. Thus, priming of AC1702 places the apheresis system 200 in the state shown in FIG. 17G. The states of the various components of the apheresis system 200 during this step are as follows:

[0170] [Table 5]

[0171] 17G, the direction of the AC pump 216 may be reversed. At least a portion of the anticoagulant 1702 may be pumped back into the AC bag 114 and / or through a portion of the cassette inlet tubing 108A and / or anticoagulant tubing 110. In at least one exemplary embodiment, the cassette microcontroller 1004 may direct the inlet fluid control valve 320C to close, retaining AC in the first bypass branch 358A, the second bypass branch 358B, and / or the fluid sensor 316. The donor air detection sensor 312 may determine when the AC 1702 stops passing through the sensor 312 and send a signal to the cassette microcontroller 1004. Again, the cassette microcontroller 1004 may continue to direct the AC pump 216 for a predetermined period of time until a known amount of AC 1702 has been pumped back through the cassette inlet tubing 108A. Thus, AC 1702 remains in apheresis system 200 in the state shown in FIG. 17G. The amount of anticoagulant remaining in cassette inlet tubing 108A, tubing connector 106, and / or anticoagulant tubing 110 may be determined by cassette microcontroller 1004 by a predetermined time after anticoagulant 1702 passes donor air detection sensor 312. This process leaves some anticoagulant in cassette inlet tubing 108A, but by reducing the amount of AC used, the problem of excessive AC mixing with the incoming whole blood is avoided. Apheresis system 200 is ready and able to draw whole blood at step 1212 ( FIG. 12 ) . The states of various components of apheresis system 200 during this step are as follows:

[0172] [Table 6]

[0173] FIG. 14 illustrates an exemplary method 1400 illustrating the plasma draw phase 1212, according to an embodiment of the present disclosure. Method 1400 begins at start step 1404 and ends at step 1440. Method 1400 may include more or fewer steps, or the steps may be ordered differently than shown in FIG. 14. Method 1400 may be implemented, at least in part, as a set of computer-executable instructions executed by a computer system, a processor, the cassette microcontroller 1004, the centrifuge microcontroller 1104, and / or other device. The set of instructions may be encoded or stored on a computer-readable medium. In at least one exemplary embodiment, method 1400 may be implemented, at least in part, by a series of components, circuits, and / or gates fabricated in a hardware device, such as a SOC, an ASIC, and / or an FPGA. Method 1400 will be described below in relation to, for example, the systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signaling processes, models, environments, apheresis systems, and / or methods described in relation to Figures 1-13.

[0174] In step 1408, the donor 102 is needled. A phlebotomist, apheresis technician, or other medical professional attaches a needle having a lumen to the tubing fitting 504 and inserts the needle into a blood vessel (e.g., a vein) of the donor 102. The apheresis system 200 is thus fluidly connected to the donor 102 and is ready to draw whole blood. Thus, the apheresis system 200 begins the plasma draw phase 1212 with the donor 102 ready to provide whole blood, as shown in FIG. 17H. The states of the various components of the apheresis system 200 during this step are as follows:

[0175] [Table 7]

[0176] The cassette microcontroller 1004 of the apheresis system 200 begins drawing whole blood 1706 in step 1412. The cassette microcontroller 1004 instructs the AC pump 216, the draw pump 208, and / or the return pump 212 to operate in a clockwise rotational direction. The AC pump 216 pumps the anticoagulant 1702 toward the plasma collection bottle 122 so that the AC 1702 mixes with the whole blood 1706 being drawn from the donor 102 into the tubing connector 106 (and, optionally, into the donor supply tubing 104) and other components distal to the tubing connector 106. The draw pump 208 and / or return pump 212 draw the whole blood 1706 (and AC) from the donor 102 into the soft cassette 340, the flexible loop 524, and / or the blood component separation bladder 536. During this process 1412, the cassette microcontroller 1004 and the centrifuge microcontroller 1008 communicate to notify the centrifuge microcontroller 1008 that draw has begun. In response to the draw start notification, the centrifuge microcontroller 1008 instructs the rotor motor assembly 414 of the centrifuge assembly 400 to begin rotating or spinning. The initial rotation speed is slow enough to allow the blood component separation bladder 536 to seat within the filler insert chamber 492 and to draw whole blood 1706 into the blood component separation bladder 536. The state of the apheresis system 200 during this step 1412 is as shown in FIG. 17I. The states of the various components of the apheresis system 200 during this step are as follows:

[0177] [Table 8]

[0178] In step 1416, whole blood 1706 is primed into the region of the blood component separation bladder 536 adjacent to the channel inlet 468, the channel end 472, and / or the channel path jog 476. The cassette microcontroller 1004 stops operation of the return pump 212 but continues to operate the AC pump 216 and the draw pump 208. The whole blood 1706 is forced through the first tubing section 368A, the drip chamber 354, and / or the second tubing section 368B. From the soft cassette 340, the whole blood 1706 is forced through the flexible loop 524 into the blood component separation bladder 536 and out the bladder free end 540B. The anticoagulant pump 216 continues to operate to mix anticoagulant 1702 from the anticoagulant bag 114 with the whole blood 1706 being drawn from the donor 102. Apheresis system 200 will be as shown in Figure 17J during step 1416. The states of various components of apheresis system 200 will be as shown below during this step:

[0179] [Table 9]

[0180] Further communications occur between the cassette microcontroller 1004 and the centrifuge microcontroller 1008 to signal the priming of the channels. In response to these communications, the centrifuge microcontroller 1008 instructs the rotor motor assembly 414 of the centrifuge assembly 400 to rotate or spin at a higher rotational speed (RPM).

[0181] In step 1420, the cassette microcontroller 1004 begins the initial draw of plasma 1704 or other blood components from the whole blood 1706. The cassette microcontroller 1004 continues to operate the AC pump 216 to supply anticoagulant 1702 into the cassette inlet tubing 108A to mix with the whole blood 1706 from the donor 102. Additionally, the cassette microcontroller 1004 continues to operate the draw pump 208 to move the whole blood 1706 into the blood component separation bladder 536 to separate the plasma 1704 from the whole blood 1706. To effect separation of the plasma 1704, the cassette microcontroller 1004 notifies the centrifuge microcontroller 1008 that the draw step has begun. In response to these communications, the centrifuge microcontroller 1008 instructs the rotor motor assembly 414 of the centrifuge assembly 400 to begin rotating or spinning at a higher revolutions per minute (RPM) (e.g., approximately 5000 RPM) to begin separating the red blood cells 1708 from the plasma 1704, as shown in FIG. 17K. The draw pump 208 continues to push the plasma 1704 through the flexible loop 524, the system fixed loop connector 528, and into the loop outlet tubing 112. The draw process 1420 continues until, at some point, the platelets 1710 separated from the whole blood 1706 reach the line sensor 812, as shown in FIG. 17L. The line sensor 812 notifies the cassette microcontroller 1004 that the entire amount of plasma 1704 has been extracted from the whole blood 1706 that was pumped into the blood component separation bladder 536. The cassette microcontroller 1004 proceeds to step 1424. The states of the various components of the apheresis system 200 during this step are as follows:

[0182] [Table 10]

[0183] Additionally or alternatively, the radial position of the interface 1709 between the plasma 1704 and red blood cells (RBCs) 1708 and / or the RBC interface 1709 within the blood component separation bladder 536 is determined as the RBC interface 1709 rises in the centrifugal force field during separation of the plasma 1704. The radial position of the interface 1709 may be determined by fluid monitoring the inlet pressure of the centrifuge assembly 400. For example, sensor 808 located on or in tube 108B determines the inlet pressure to the centrifuge assembly 400. Alternatively, another sensor located on or in the flow path to the centrifuge assembly 400 may determine the inlet pressure. As the RBC interface 1709 rises within the blood component separation bladder 536, the plasma 1704 is displaced by the red blood cells 1708 within the RBC bed. With each incremental increase (delta R) in the radial position of RBC interface 1709, the backpressure affecting the inlet pressure to centrifuge assembly 400 (e.g., backpressure relative to sensor 808 or other sensor) increases according to delta R multiplied by the average centrifugal force field (G) between the radial position of the channel inlet and the radial position of RBC interface 1709 and the RBC layer density minus the plasma density. Simply stated, the backpressure affecting the inlet pressure to the centrifuge assembly increases by the following formula: delta R x (RBC layer density - plasma density) x G. For example, in at least one exemplary embodiment, the total change in backpressure from the onset of RBC layering to the exit of the RBCs at the center of rotation is approximately 220 mmHg when the centrifuge is rotating at approximately 5000 RPM and RBC layering begins at a radius of approximately 67 mm.

[0184] When platelets 1710, red blood cells, high hematocrit blood, and / or other blood components reach the line sensor 812, as determined by the sensor 812 observing a change in fluid color or other characteristic, the cassette microcontroller 1004 determines whether blood collection is complete in step 1426. Completion of blood collection means that the entire amount of plasma 1704 needed or desired has been drawn into the plasma collection bottle 122. In at least one exemplary embodiment, the cassette microcontroller 1004 determines whether the complete collection amount (e.g., 880 mL) has been extracted by weight or volume. This situation is shown in FIG. 17L. In this situation, plasma 1704 is being extracted and, simultaneously, is present in the loop outlet tubing 112 and is being delivered to the plasma collection bottle 122 via the plasma tubing 120. If it is an incomplete blood collection (i.e., the plasma collection bottle 122 has not reached the desired weight or volume limit), the method 1400 returns NO and proceeds to return step 1428. If it is a complete blood collection, the method 1400 returns YES and proceeds to a final return step 1432.

[0185] Alternatively, if the RBC interface 1709 is determined to be at the radially innermost position, the cassette microcontroller 1004 determines in step 1426 whether blood collection is complete. For example, the radially innermost position is adjacent the filler loop connector 532. Completion of blood collection means that the entire amount of plasma 1704 needed or desired has been drawn into the plasma collection bottle 122. In at least one exemplary embodiment, the cassette microcontroller 1004 determines whether a complete amount (e.g., 880 mL) has been extracted by weight or volume. This situation is shown in FIG. 17L , where plasma 1704 has been extracted and is still present in the loop outlet tubing 112 and is being delivered to the plasma collection bottle 122 through the plasma tubing 120. If it is an incomplete blood collection (i.e., the plasma collection bottle 122 has not reached the desired weight or volume limit), the process 1400 returns NO and proceeds to step 1428. If it is a complete blood collection, the method 1400 transitions YES to a final return step 1432 .

[0186] By performing return step 1428 when RBC interface 1709 is determined to be at the innermost radial position rather than when platelets 1710, red blood cells, high hematocrit blood, and / or other blood components reach line sensor 812, the time to complete retraction process 1420 is reduced, and the overall time to complete method 1400 is reduced.

[0187] 17L, in a return step 1428, the cassette microcontroller 1004 commands the draw pump 208 to stop and reverses the direction of rotation of the return pump 212 so that it runs counterclockwise, forcing plasma 1704 from the plasma collection bottle 122, through the plasma tubing 120, and into the loop outlet tubing 112 toward the flexible cassette 340. The cassette microcontroller 1004 also commands the draw fluid control valve 320C to close and commands both the first fluid control valve 320A and the second fluid control valve 320B to open. These changes cause the plasma 1704 to push red blood cells 1708 and platelets 1710 through the loop outlet tubing 112, the flexible loop 524, the apheresis bladder 536, and through the drip chamber 354 toward the donor 102. Importantly, as can be seen in FIG. 17L , the filler 460 continues to rotate at the extraction speed (e.g., 5000 RPM) during this return step 1428. The system 200 continues to push the red blood cells 1708 back toward the donor 102 until the color / pressure sensor 808 determines that plasma 1704 may have passed the sensor 808 and reached the drip chamber 354, as shown in FIG. 17M . At that point, valves 320B, 320A are again closed, allowing whole blood 1706 to again flow through the first bypass branch 358A, the second bypass branch 358B, and / or the fluid sensor 316. The states of the various components of the apheresis system 200 during this step 1428 are as follows:

[0188] [Table 11]

[0189] Return step 1428 transitions to second draw step 1420. The new draw proceeds in a manner similar to step 1420 described above. However, there is a portion of high-hematocrit blood remaining in drip chamber 354. By directing the new flow of whole blood 1706 through first bypass branch 358A, second bypass branch 358B, and / or fluid sensor 316, most of the high-hematocrit blood is not returned to blood component separation bladder 536, and more plasma 1704 cannot be extracted from its red blood cells. Thus, the bypass provided by soft cassette 340 allows for more efficient removal of plasma 1704 from whole blood 1706 during second draw step 1420 and subsequent draw steps.

[0190] The return step 1428 and subsequent draw step 1420 are repeated several times. The final draw step 1420 is shown in FIG. 17N. As shown in FIG. 17N, the plasma 1704 in the plasma collection bottle 122 has reached a desired and / or maximum volume, e.g., 880 mL. Once the plasma 1704 has reached the desired and / or maximum volume in the plasma collection bottle 122, a final return is requested in step 1432. The states of the various components of the apheresis system 200 during this return step are as follows:

[0191] [Table 12]

[0192] In step 1432, all of the plasma 1704 extracted from the donor 102 is in the plasma collection bottle 122, and the apheresis system 200 can push the red blood cells 1708 and any other blood components back to the donor 102 through the remaining plasma 1704. The cassette microcontroller 1004 instructs the plasma flow control valve 286 to close, maintaining the collected plasma in the plasma collection bottle 122. The return pump 212 continues to rotate counterclockwise, pushing the red blood cells 1708 and any plasma 1704 or other blood components back to the donor 102.

[0193] After, or as part of, the final return 1432, saline 1712 is also returned to the donor 102 in step 1436, as shown in FIG. 17O. In this step 1436, the cassette microcontroller 1004 opens the saline flow control valve 288 and leaves the first fluid control valve 320A and the second fluid control valve 320B open. The return pump 212 continues to run in a counterclockwise direction. The centrifuge microcontroller 1008 stops the rotation of the filler 460. The saline 1712 from the saline bag 118 is pushed back to the donor 102 through the blood component separation bladder 536, the drip chamber 354, and various tubing. Any blood components remaining in the blood component collection set 500 are pushed back to the donor 102 along with some amount of saline 1712. The saline 1712 serves as fluid replacement for the donor 102 and is required in some jurisdictions. This return of saline 1712 continues until a predetermined amount of saline 1712 has been delivered to the user, as determined by the weight or volume of saline 1712 exiting the saline bag 118. As shown in Figure 17O, plasma collection is complete. The states of the various components of the apheresis system 200 during this step are as follows:

[0194] [Table 13]

[0195] FIG. 15 illustrates an exemplary method for removing a plasma or blood component collection set 500 from an apheresis system 200, as described in removal step 1216, according to at least one exemplary embodiment of the present disclosure. Method 1500 begins with start step 1504 and ends with step 1528. Method 1500 may include more or fewer steps, or the steps may be ordered differently than shown in FIG. 15. Method 1500 may be implemented, at least in part, as a set of computer-executable instructions executed by a computer system, a processor, a cassette microcontroller 1004, a centrifuge microcontroller 1104, and / or other device. The set of instructions may be encoded or stored on a computer-readable medium. In at least one exemplary embodiment, method 1500 may be implemented, at least in part, by a series of components, circuits, and / or gates fabricated in a hardware device, such as a SOC, an ASIC, and / or an FPGA. Method 1500 will be described below in relation to, for example, the systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signaling processes, models, environments, apheresis systems, and / or methods described in relation to Figures 1-14.

[0196] In step 1508, a vacuum is applied to the channels. In at least one exemplary embodiment, the cassette microcontroller 1004 continues to operate the draw pump 208 counterclockwise, as shown in FIG. 17P, to substantially completely pump the saline 1712 out of the blood component separation bladder 536 and the remainder of the blood component collection set 500. At some point, substantially all of the blood components and / or saline 1712 will be pumped back into the donor 102, in which case operation of all pumps 216, 208, 212 will be stopped. The fluid control valve 320A, the first fluid control valve 320A, the saline flow control valve 288, and any other valves will be closed by the cassette microcontroller 1004. With the various valves closed, only a small amount or no saline 1712 should remain in the blood component collection set 500. The state of the apheresis system 200 is shown in FIG. 17Q. The states of the various components of the apheresis system 200 during this step are as follows:

[0197] [Table 14]

[0198] The blood component collection set 500 is sealed in step 1512, as shown in FIG. 17R. Sealing the blood component collection set 500 can include clamping the donor supply tubing 104 leading to the donor 102 and heat-sealing the tubing at various locations. As shown in FIG. 17R, because the tubing is thermoplastic, sealing is accomplished by heat-sealing the tubing. For example, the anticoagulant tubing 110, saline tubing 116, plasma tubing 120 (upstream of the plasma flow control valve 286), and donor supply tubing 104 are all heat-sealed to separate the AC bag 114, plasma collection bottle 122, saline bag 118, and donor 102 from the rest of the blood component collection set 500. The states of the various components of the apheresis system 200 during this step are as follows:

[0199] [Table 15]

[0200] In step 1516, the needle is withdrawn from donor 102, as shown in Figure 17R. The states of various components of apheresis system 200 during this step are as follows:

[0201] [Table 16]

[0202] In step 1520, the blood component collection set 500 is removed from the apheresis system 200. This involves reversing at least a portion of the procedure described in connection with Figures 13 and 16. The states of the various components of the apheresis system 200 during this step are as follows:

[0203] [Table 17]

[0204] Once removed, the used blood component collection set 500 is discarded as medical waste. As shown in FIG. 17S, the plasma collection bottle 122 is sealed to the plasma tubing 120. The sealed area prevents any liquid from leaking from the plasma collection bottle 122, the saline bag 118, or the anticoagulant bag 114. Once sealed, the plasma collection bottle 122 is removed and used in a procedure requiring plasma. The remaining components may be discarded as medical waste. As shown in FIG. 17T, in step 1524, the procedure is complete. The state of the various components of the apheresis system 200 at the end of the procedure is as follows:

[0205] [Table 18]

[0206] FIG. 16 illustrates an exemplary method 1600 for inserting disposables into a filler of an apheresis system 200, according to at least one exemplary embodiment of the present disclosure. Method 1600 begins at start step 1604 and ends at step 1632. Method 1600 may include more or fewer steps, or the steps may be ordered differently than shown in FIG. 16. Method 1600 may be implemented, at least in part, as a set of computer-executable instructions executed by a computer system, a processor, cassette microcontroller 1004, centrifuge microcontroller 1104, and / or other device. The set of instructions may be encoded or stored on a computer-readable medium. In at least one exemplary embodiment, method 1600 may be implemented, at least in part, by a series of components, circuits, and / or gates fabricated in a hardware device, such as a SOC, an ASIC, and / or an FPGA. Method 1600 will be described below in relation to, for example, the systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signaling processes, models, environments, apheresis systems, and / or methods described in relation to Figures 1-15.

[0207] In step 1608, a filler 460 of the apheresis system 200 is provided. The filler 460 is a component of the apheresis system 200 and is configured to receive at least a portion of the blood component collection set 500. In at least one exemplary embodiment, the filler 460 is mounted on a split housing pivot 406 that pivots to expose the interior of the upper housing 404B that houses the filler 460. A user can rotate the upper housing 404B to expose the separate insertion channel 466, or, in at least one exemplary embodiment, the filler 460 is automatically rotated by a motor or other mechanical device. This rotation and / or mounting can be performed as described above in connection with FIGS. 4D-4F and / or 6A-6C.

[0208] In step 1612, a blood component collection set 500 including a blood component separation bladder 536 is provided. The blood component collection set 500 is packaged and removed from the package. The user exposes the blood component separation bladder 536 and inserts it into the separation insert channel 466. This involves securely positioning the bladder free end 540B in the channel path jog 476 of the separation insert channel 466 and securely positioning the filler loop connector 532 in the loop connection region 454. With the blood component separation bladder 536 properly positioned, the user deforms the blood component separation bladder 536 to the shape of the separation insert channel 466 and the channel path jog 476 in step 1616, as shown in FIGS. 5F-5H. In this manner, the user forms the blood component separation bladder 536 into a generally circular shape or any other shape to fit the shape of the separation insert channel 466.

[0209] In step 1620, the user inserts the contoured blood component separation bladder 536 into the separation insertion channel 466 of the filler 460 with the free bladder end 540B of the blood component separation bladder 536 inserted into the channel path jog 476 of the separation insertion channel 466, as shown in FIGS. 5G-5H. The user inserts the blood component separation bladder 536 into the separation insertion channel 466 at an approximately central position within the filler insertion chamber 492. Centrifugal force automatically aligns the blood component separation bladder 536 to the correct position within the filler insertion chamber 492. However, if the blood component separation bladder 536 is not positioned properly when centrifugal force acts on it, the blood component separation bladder 536 will be removed from the separation insertion channel 466. Once positioned, the blood component separation bladder 536 is secured in place.

[0210] In step 1624, the user connects the filler loop connector 532 of the blood component separation bladder 536 to the loop connection region 454 of the separation insert channel 466. The mechanical connection may be made by the user snapping the filler loop connector 532 into the loop connection region 454. The dimensions and physical features of the filler insert chamber 492 hold the blood component separation bladder 536 in a stable position such that the filler loop connector 532 remains stable within the loop connection region 454 and the blood component separation bladder 536 can be centered in the filler insert chamber 492 during operation of the centrifuge 400. The portion of the flexible loop 524 remaining external or outside of the filler 460 is attached to the loop capture arm 416. This attachment of the flexible loop 524 enables 1ω / 2ω operation of the centrifuge 400.

[0211] After the flexible loop 524 is attached, in step 1628, the upper housing 404B is rotated 180 degrees into position. Thus, the filler 460 is rotated into the interior of the system housing 204 by the hinge axis 406 (e.g., a hinge). The centrifuge partition housing 404 is rotated with the blood component collection loop 520 passing through the loop access clearance 436 of the centrifuge partition housing 404. When the blood component collection loop 520 is attached to the loop attachment location 520A, a portion of the blood component collection loop 520 is partially received, held, and / or supported by the loop storage bracket 426, as described in connection with FIGS. 4A-4C . The access panel 224 is rotated to a closed position, which allows operation of the system 200.

[0212] With respect to apheresis methods and systems, exemplary systems and methods of the present disclosure have been described. However, to avoid unnecessarily obscuring the present disclosure, the foregoing description omits some known structures and devices. This omission should not be construed as limiting the scope of the disclosure as set forth in the claims. Specific details are set forth to provide an understanding of the present disclosure. However, it should be understood that the present disclosure may be practiced in various ways other than the specific details set forth herein.

[0213] Additionally, while the aspects, embodiments, and / or configurations illustrated herein show various components of a system being distributed, certain components of the system may be remotely located, such as in a remote portion of a distributed network, such as a LAN and / or the Internet, or within a dedicated system. Accordingly, it should be understood that system components may be combined into one or more devices, such as cassette node 904 and centrifuge node 908, or that system components may be located at particular nodes of a distributed network, such as an analog and / or digital telecommunications network, a packet-switched network, or a circuit-switched network. From the foregoing discussion, it is also understood that, for computational efficiency, system components may be located anywhere within a distributed network of components without affecting system operation. For example, various components may be located in switches, such as PBXs and media servers, gateways, one or more communications devices, one or more user premises, or some combination thereof. Similarly, one or more functional portions of the system may be disposed between a remote communications device and an associated computing device.

[0214] It should further be understood that the various links connecting the elements may be wired or wireless links, or any combination thereof, or any other known or later developed elements capable of providing and / or communicating data to and from the connected elements. These wired or wireless links may also be secure links and may be capable of communicating encrypted information. Transmission media used as links may be any suitable carrier for electrical signals, including, for example, coaxial cable, copper wire, and optical fiber, or may take the form of acoustic or light waves, such as those generated during radio wave and infrared data communications.

[0215] Also, while the flowcharts have been discussed and illustrated with respect to a particular sequence of events, it should be understood that modifications, additions, and omissions can be made to this sequence without substantially affecting the operation of the disclosed embodiments, configurations, and aspects.

[0216] Many variations and modifications of the present disclosure may be employed: some features of the present disclosure may be provided without other features.

[0217] In still other embodiments, the systems and methods of this disclosure may be implemented in connection with special purpose computers, programmed microprocessors or microcontrollers and peripheral integrated circuit elements, ASICs or other integrated circuits, digital signal processors, logic circuits such as hard-wired electronics or discrete component circuits, programmable logic devices or gate arrays, e.g., PLDs, PLAs, FPGAs, PALs, special purpose computers, any equivalent means, etc. In general, any device or means capable of implementing the methodologies described herein may be used to implement various aspects of this disclosure. Exemplary hardware that may be used for the disclosed embodiments, configurations, and aspects includes computers, mobile devices, phones (e.g., cellular, Internet-enabled, digital, analog, hybrid, etc.), and other hardware known in the art. Some of these devices include processors (e.g., single or multiple microprocessors), memory, non-volatile storage, input devices, and output devices. Furthermore, other software implementations, including, but not limited to, distributed processing or component / object distributed processing, parallel processing, or virtual machine processing, may also be constructed to perform the methods described herein.

[0218] In yet other embodiments, the disclosed methods may be readily implemented in connection with software using object or object-oriented software development environments that provide portable source code that can be used on a variety of computer or workstation platforms. Alternatively, the disclosed systems may be implemented partially or fully in hardware using standard logic circuits or VLSI designs. Whether software or hardware is used to implement a system according to this disclosure depends on the speed and / or efficiency requirements of the system, the particular functionality, and the particular software or hardware system or microprocessor or microcomputer system being utilized.

[0219] In yet other embodiments, the disclosed methods may be implemented in part in software that may be stored on a storage medium and executed by a programmed general-purpose computer, special-purpose computer, microprocessor, etc. in cooperation with a controller and memory. In these cases, the disclosed systems and methods may be implemented as programs embedded in a personal computer, such as applets, JAVA or CGI scripts, as resources residing on a server or computer workstation, as dedicated measurement systems, routines embedded in system components, etc. The systems may also be implemented by physically incorporating the systems and / or methods into software and / or hardware systems.

[0220] Although this disclosure describes components and functions implemented in aspects, embodiments, and / or configurations related to particular standards and protocols, the aspects, embodiments, and / or configurations are not limited to such standards and protocols. Other similar standards and protocols not mentioned herein exist and are considered to be included in this disclosure. Furthermore, the standards and protocols mentioned herein, as well as other similar standards and protocols not mentioned herein, are periodically superseded by faster or more efficient equivalents having substantially the same functionality. Such replacement standards and protocols having the same functionality are considered to be equivalents included in this disclosure.

[0221] The present disclosure in its various aspects, embodiments, and / or configurations includes components, methods, processes, systems, and / or apparatus substantially as illustrated and described herein, including various aspects, embodiments, configuration embodiments, subcombinations, and / or subsets thereof. Those skilled in the art will understand how to make and use the disclosed aspects, embodiments, and / or configurations after understanding the present disclosure. The present disclosure in its various aspects, embodiments, and / or configurations includes providing devices and processes in the absence of items not illustrated and / or described herein or in its various aspects, embodiments, and / or configurations, including the absence of items that may be used in the previous devices or processes, e.g., to improve performance, ease, and / or reduce implementation costs.

[0222] The foregoing description has been provided for purposes of illustration and description. It is not intended to limit the disclosure to the form or forms disclosed herein. For example, in the foregoing Detailed Description, various features of the disclosure are grouped together in one or more aspects, embodiments, and / or configurations for the purpose of streamlining the disclosure. Features of the aspects, embodiments, and / or configurations of the disclosure may be combined in alternative aspects, embodiments, and / or configurations other than those described above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and / or configuration. Accordingly, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the present disclosure.

[0223] Furthermore, while the specification has included a description of one or more aspects, embodiments, and / or configurations, and certain variations and modifications, other variations, combinations, and modifications may be within the scope of the present disclosure, e.g., within the skill and knowledge of one of ordinary skill in the art, after understanding the present disclosure, including alternative and / or equivalent structures, functions, ranges, or steps in place of those set forth in the claims, whether or not such alternative and / or equivalent structures, functions, ranges, or steps are disclosed herein, and to the extent permitted, entitlement to include other aspects, embodiments, and / or configurations without publicly seeking to use any patentable subject matter.

Claims

1. 1. A method of collecting a blood component, the method comprising: drawing whole blood into a centrifuge; rotating the centrifuge to apply centrifugal force to the whole blood, thereby separating the whole blood into at least a first blood component and a second blood component different from the first blood component; extracting the first blood component from the centrifuge; detecting when the second blood component is about to be extracted from the centrifuge; after the second blood component is detected, flowing the separated first blood component back toward the centrifuge while the centrifuge continues to rotate, thereby removing at least the second blood component from the centrifuge; have Methods for collecting blood components.

2. 10. The method of collecting blood components according to claim 1, the first blood component comprises plasma, platelets, red blood cells, high hematocrit blood, or a combination thereof; Methods for collecting blood components.

3. 3. The method of collecting blood components according to claim 2, the second blood component comprises plasma, platelets, red blood cells, high hematocrit blood, or a combination thereof; Methods for collecting blood components.

4. 3. The method of collecting blood components according to claim 2, the second blood component comprises red blood cells; Methods for collecting blood components.

5. 10. The method of collecting blood components according to claim 1, the centrifuge rotates at a first speed when separating the first blood component from the whole blood; Methods for collecting blood components.

6. 6. The method of collecting blood components according to claim 5, the centrifuge continues to rotate at the first speed as the separated first blood component flows back towards the centrifuge. Methods for collecting blood components.

7. 7. The method of collecting blood components according to claim 6, the centrifuge spins at a second speed as the whole blood is drawn into the centrifuge. Methods for collecting blood components.

8. 8. The method of collecting blood components according to claim 7, The second speed is slower than the first speed. Methods for collecting blood components.

9. 10. The method of collecting blood components according to claim 1, the centrifuge is configured to receive a blood component collection set, the blood component collection set being configured to receive the first blood component; Methods for collecting blood components.

10. 10. The method of collecting blood components according to claim 9, The method further comprises inserting the blood component collection set into the centrifuge. Methods for collecting blood components.

11. 10. The method of collecting blood components according to claim 9, the blood component collection set includes a blood component separation bladder that separates the first blood component; Methods for collecting blood components.

12. 12. The method of collecting a blood component according to claim 11, the centrifuge includes a filler configured to rotate the blood component separation bladder. Methods for collecting blood components.

13. 13. The method of collecting blood components according to claim 12, the filler includes a separation insert channel configured to receive the blood component separation bladder. Methods for collecting blood components.

14. 14. The method of collecting a blood component according to claim 13, The method further comprises inserting the blood component separation bladder into the separation insertion channel of the filler. Methods for collecting blood components.

15. 10. The method of collecting blood components according to claim 1, the step of detecting when the second blood component is about to be extracted from the centrifuge includes detecting an interface between the first blood component and the second blood component. Methods for collecting blood components.

16. 16. The method of collecting a blood component according to claim 15, The method further comprises detecting a radial position of the interface between the first blood component and the second blood component in the centrifuge. Methods for collecting blood components.

17. 10. The method of collecting blood components according to claim 1, The method further comprises monitoring an inlet pressure of the whole blood entering the centrifuge. Methods for collecting blood components.

18. 18. The method of collecting a blood component according to claim 17, the step of monitoring the inlet pressure includes receiving a signal output from a sensor disposed at the inlet of the centrifuge. Methods for collecting blood components.

19. 20. The method of collecting a blood component according to claim 18, The method further comprises determining a back pressure at the inlet of the centrifuge. Methods for collecting blood components.

20. 20. The method of collecting a blood component according to claim 19, The method further comprises equating a change in backpressure with a radial position of the interface between the first blood component and the second blood component in the centrifuge. Methods for collecting blood components.

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