Mobile blood component collection loop holder

Abstract

The apheresis system includes a chamber configured to receive a centrifuge assembly and a traveling loop holder. The traveling loop holder has a loop holder body having a loop connecting portion configured to interact with a flexible loop received by the centrifuge assembly. The traveling loop holder is configured to move between a first position and a second position, where in the first position the traveling loop holder is at a first distance from the centrifuge assembly and in the second position the traveling loop holder is at a second distance from the centrifuge assembly. When the traveling loop holder is in the first position, the centrifuge assembly is prevented from moving from an operating state to a loaded state, and when the traveling loop holder is in the second position, the centrifuge assembly is allowed to move from an operating state to a loaded state.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 318,668, filed Mar. 10, 2022, and claims the priority of U.S. Patent Application No. 18 / 116,902, filed Mar. 3, 2023. The entire disclosure of the above applications is incorporated herein by reference.

[0002] This disclosure relates to a mobile blood component collection loop holder for use in an apheresis system.

Background Art

[0003] This section provides background information related to this disclosure, which is not necessarily prior art.

[0004] There are two generally known methods for blood donation / collection. The first general method is to receive whole - blood donation from a donor. When whole blood is obtained, a centrifugation process can be used to separate blood components from the whole blood, for example, based on the density of different blood components. The desired components can be moved manually, semi - automatically, or automatically into a collection container during and / or after the application of centrifugal force. The second general method is called apheresis collection, which requires a special device. For example, in the apheresis method, whole blood is extracted from a donor while the donor is connected to an apheresis device, which is a special device. Then, the whole blood is centrifuged to collect only the desired blood component (e.g., plasma), and all other blood components are returned to the donor during the same blood supply connection or cycle. The donor remains connected to the apheresis device during the separation and collection of blood components.

Summary of the Invention

Problems to be Solved by the Invention

[0005] However, the apheresis process has disadvantages, such as being time-consuming and uncomfortable for donors. For example, donors often have to remain connected to a special apheresis device for more than an hour for blood component donation. Therefore, there is a need to develop processes and improve special apheresis devices to improve the comfort and efficiency of blood component donation procedures. [Means for solving the problem]

[0006] This section provides a general overview of the disclosure and does not constitute a comprehensive disclosure of its entire scope or all features.

[0007] There is a need for plasma or other blood component systems that can shorten the blood donation time and enhance donor comfort. Embodiments provided herein can improve the efficiency of the blood collection process by using separated blood components to push or push back unintended blood components to the donor without stopping and restarting a centrifuge. For example, in at least one exemplary embodiment, the Disclosure provides a method and apparatus for positioning, for example, a portion of a disposable item (e.g., a loop) within a medical device. In at least one exemplary embodiment, the Disclosure provides a system including, for example, a surface for automatically guiding a loop. In at least one exemplary embodiment, the Disclosure provides a medical device including, for example, a blood separation device such as an apheresis device.

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

[0009] In at least one exemplary embodiment, the present disclosure provides a centrifuge assembly. The centrifuge assembly includes a centrifuge housing having an outer surface and an internal cavity. The centrifuge housing rotates about an axis of rotation of the centrifuge assembly. The centrifuge assembly has a fluid separation body at least partially disposed within the internal cavity of the centrifuge housing. The fluid separation body is configured to rotate relative to the centrifuge housing about the axis of rotation of the centrifuge assembly. The centrifuge assembly has a fluid line loop arm attached to a portion of the centrifuge housing and extending along the length of the outer surface of the centrifuge housing. The fluid line loop arm includes a bearing set positioned at a point along the length of the outer surface, the bearing set being configured to contact a tubular portion of an interconnected fluid line loop, holding the fluid line loop in an engaged position relative to the centrifuge housing, while allowing the fluid line loop to rotate in the engaged position. In at least one exemplary embodiment, the bearing set may include a pair of roller bearings. In at least one exemplary embodiment, the bearing set may include a plurality of pairs of roller bearings. In at least one exemplary embodiment, the centrifuge assembly may be part of an apheresis apparatus. In at least one exemplary embodiment, the fluid line loop is attached at a first end to a fixed, non-rotating part of the apheresis apparatus via a first positively-located connector, and the fluid line loop is interconnected at a second end to the fluid separation body in 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 together 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 via the second positively-located connector.In at least one exemplary embodiment, the fluid line loop may include a plurality of lumens. In at least one exemplary embodiment, the fluid separation bladder may include a first flexible sheet that is attached to a second flexible sheet to form a fluid path, the first portion of the fluid path being narrower than the second portion of the fluid path.

[0010] In at least one exemplary embodiment, the Disclosure provides a method for automatically mounting a fluid line loop to a centrifuge assembly. The method includes the steps of: attaching the fluid line loop to the fluid separation body of the centrifuge assembly at a first end; and rotating the fluid separation body relative to the housing of the centrifuge assembly in a first rotational direction, wherein rotating the fluid separation body rotates the fluid line loop relative to the housing and guides it into a channel of a loop arm attached to a portion of the housing. The channel includes bearings arranged in a bearing set attached to the loop arm. The bearings hold the fluid line loop in a predetermined position relative to the housing as the centrifuge assembly rotates. In at least one exemplary embodiment, the bearings may contact a portion of the fluid line loop as it rotates in the channel relative to the housing. In at least one exemplary embodiment, the centrifuge housing rotates in a first rotational direction at a first angular velocity about a rotation axis, and the fluid separation body rotates at a different second angular velocity about the rotation axis due to a torsional force provided 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 that is at least partially located within the fluid separation body. In at least one exemplary embodiment, the method further comprises the steps of attaching the second end of the fluid line loop to a point fixed in the rotational direction of the apheresis device, and rotating the centrifuge assembly about the rotation axis with respect to the point fixed in the rotational direction of the apheresis device (e.g., via the rotor motor assembly of the apheresis device).

[0011] In at least one exemplary embodiment, the Disclosure provides a method for collecting blood components through apheresis. The method comprises the steps of: drawing whole blood from a donor into a centrifuge; rotating the centrifuge to apply centrifugal force to the whole blood and separating 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 has been detected, returning the separated first blood component to the centrifuge and moving at least the third blood component from the centrifuge back to the donor while the centrifuge continues to rotate. In at least one exemplary embodiment, the first blood component may include one or more of plasma, platelets, red blood cells, and / or high hematocrit blood. In at least one exemplary embodiment, the second blood component may comprise one or more of plasma, platelets, red blood cells, and / or high hematocrit blood. In at least one exemplary embodiment, the third blood component may comprise one or more of plasma, platelets, red blood cells, and / or high hematocrit blood. In at least one exemplary embodiment, the first blood component may comprise two or more of plasma, platelets, red blood cells, and / or high hematocrit blood. In at least one exemplary embodiment, the centrifuge may rotate at a first speed when separating the first blood component from the whole blood. In at least one exemplary embodiment, the centrifuge may continue to rotate at the first speed when returning the separated first blood component to the centrifuge. In at least one exemplary embodiment, the centrifuge may rotate at a second speed when drawing whole blood from the donor into the centrifuge. In at least one exemplary embodiment, the second speed may be slower than the first speed. In at least one exemplary embodiment, the first blood component may include the blood separated from the whole blood in a blood component collection set inserted into the centrifuge.In at least one exemplary embodiment, the centrifuge may include a filler for rotating a blood component collection bladder associated with the blood component collection set. In at least one exemplary embodiment, the blood component collection bladder may be inserted into and held in a collection insertion channel formed in the filler.

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

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

[0014] In at least one exemplary embodiment, the disclosure provides a filler configured to hold a separation bladder from which components are separated from a composite fluid. The filler comprises a channel for holding the separation bladder during the separation of components from the composite fluid. The channel has a first wall and a second wall opposite the first wall. The first end of the channel is adjacent to the center of the filler, and the channel is helical toward the outer circumference of the filler. In at least one exemplary embodiment, the top of the channel may be narrower than the central portion of the channel. In at least one exemplary embodiment, at least a portion of the second wall may be concave. In at least one exemplary embodiment, the second end of the channel may be positioned to receive a higher gravitational force than the first end during separation. In at least one exemplary embodiment, the top of the channel may provide reinforcement to the separation bladder during separation.

[0015] In at least one exemplary embodiment, the Disclosure provides a fluid separation filler, comprising a body having a pivot axis positioned substantially at the center of mass of the body, and a fluid collection insertion channel disposed within the body and following a substantially helical path extending spirally outward from a first point near the pivot axis to a second point located near the outer circumference of the body. The fluid collection insertion channel curves outward toward the outer circumference of the body near the end of the substantially helical path defining a third point of the fluid collection insertion channel located furthest from the pivot axis. In at least one exemplary embodiment, the fluid separation filler may further comprise a fluid collection chamber disposed within the body and following a portion of the substantially helical path, the fluid collection insertion channel connecting to the fluid collection chamber and defining an access area between the inside of the fluid collection chamber and the outside of the body. In at least one exemplary embodiment, the fluid collection chamber may be configured to receive a disposable fluid collection bladder. In at least one exemplary embodiment, the distance from the rotation axis to the third point of the substantially helical path may be greater than the distance from the rotation axis to the second point of the substantially helical path. In at least one exemplary embodiment, the width of the fluid collection chamber at a point along the substantially helical path may be greater than the width of the fluid collection insertion channel at a point along the substantially helical path. In at least one exemplary embodiment, the fluid collection chamber may further include a first wall following the innermost portion of the substantially helical path and a second wall substantially parallel to the first wall and following the outermost portion of the substantially helical path. In at least one exemplary embodiment, the fluid collection chamber may further include one or more tapered walls positioned between the first wall and the second wall, the one or more tapered walls being configured to guide the disposable fluid collection bladder to a seated position within the fluid collection chamber.In at least one exemplary embodiment, the fluid inlet for the disposable fluid collection bladder, when installed in the fluid collection chamber, is located adjacent to the rotation axis, and the first fluid path of the disposable fluid collection bladder follows the substantially helical path outward toward the end of the disposable fluid collection bladder located adjacent to the third point of the fluid collection insertion channel located furthest from the rotation axis, and is fluidically interconnected with a second fluid path that is separated from the first fluid path of the disposable fluid collection bladder and extends inward from the third point along the substantially helical path toward the fluid outlet for the disposable fluid collection bladder located adjacent to the rotation axis. In at least one exemplary embodiment, the fluid inlet and the fluid outlet may be part of a connector attached to the disposable fluid collection bladder, and the body of the fluid separation filler may include connection points that engage with the connector. In at least one exemplary embodiment, the connector may include at least one keying function portion, the connection point may include at least one mating keying function portion, and the keying function portion may securely position the connector relative to the connection point.

[0016] In at least one exemplary embodiment, the Disclosure provides a centrifugal separator assembly comprising: a centrifugal separator housing having an internal cavity and rotating about a rotation axis of the centrifugal separator assembly; and a fluid separator body at least partially located within the internal cavity of the centrifugal separator housing and configured to rotate relative to the centrifugal separator housing about the rotation axis. The fluid separator body has a fluid collection insertion channel located within the fluid separator body and following a substantially helical path extending spirally outward from a first point adjacent to the rotation axis to a second point located adjacent to the outer circumference of the fluid separator body. In at least one exemplary embodiment, the fluid separator body further comprises a fluid collection chamber located within the body and following a portion of the substantially helical path, wherein the fluid collection insertion channel may be connected to the fluid collection chamber to define an access area between the inside of the fluid collection chamber and the outside of the fluid separator body. In at least one exemplary embodiment, the centrifuge assembly may further include a disposable fluid collection bladder disposed within the fluid collection chamber according to the substantially helical path. The disposable fluid collection bladder may have a fluid inlet located adjacent to the rotation axis, and a first fluid path of the disposable fluid collection bladder may follow the substantially helical path outward toward the end of the disposable fluid collection bladder located adjacent to the third point of the fluid collection insertion channel located furthest from the rotation axis, and may be fluidically interconnected with a second fluid path that is separated from the first fluid path of the disposable fluid collection bladder and extends inward from the third point along the substantially helical path toward a fluid outlet for the disposable fluid collection bladder located adjacent to the rotation axis. In at least one exemplary embodiment, the centrifuge assembly may be part of an apheresis apparatus.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 and closed state about a pivot axis offset with respect to the rotation axis and substantially perpendicular to the rotation axis, and the fluid collection insertion channel of the fluid separation body may be accessible in the open state and inaccessible in the closed state.

[0017] In at least one exemplary embodiment, the present disclosure provides a blood component collection loop, the blood component collection loop comprising: a flexible loop; a system fixed loop connector located at a first end of the flexible loop, the system fixed loop connector being connected to a fixed loop connection portion of the centrifuge to fix the first end of the flexible loop so as to rotate integrally with the centrifuge; and a filler loop connector located at a second end of the flexible loop opposite to the first end, the filler loop connector being connected to a loop connection region of a filler, and a torsional force based on the twisting of the flexible loop being applied to the filler via the filler loop connector, the flexible loop being rotated to be captured by a loop rotation positioning guide positioned on the centrifuge, the flexible loop being rotated to be captured by a loop rotation positioning guide positioned on the centrifuge. In at least one exemplary embodiment, the blood component collection loop may be part of a blood component collection set, which may be associated with an apheresis system. In at least one exemplary embodiment, the loop rotation positioning guide may be mounted on a rotor that rotates the loop rotation positioning guide and the flexible loop around a rotation axis. In at least one exemplary embodiment, the blood component collection loop may be at least partially positioned by a loop positioning stopper 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 an angular velocity greater than that of the centrifuge. In at least one exemplary embodiment, the flexible loop may include two or more lumens for moving whole blood and / or blood components within the flexible loop.

[0018] In at least one exemplary embodiment, the Disclosure provides an assembly for mounting a flexible loop. The assembly comprises a loop rotation positioning guide having a channel for holding a flexible loop of a blood component collection set; a loop torsion support bearing positioned in part of the loop rotation positioning guide within the channel and supporting the flexible loop; and a loop capture arm, the loop capture arm positioned adjacent to the channel and connected to the loop rotation positioning guide, guiding the flexible loop into the channel and in contact with the loop torsion support bearing. In at least one exemplary embodiment, the assembly may be part of an apheresis apparatus, and the loop rotation positioning guide may be mounted on a centrifuge that rotates the loop rotation positioning guide and the flexible loop around a rotation axis. In at least one exemplary embodiment, the loop rotation positioning guide may further include a loop positioning stopper plate for further positioning the flexible loop. In at least one exemplary embodiment, the assembly may further include a loop storage bracket positioned coplanar with the loop rotation positioning guide and located on the centrifuge to further capture the flexible loop.

[0019] In at least one exemplary embodiment, the Disclosure provides a method for automatically mounting a flexible loop to an assembly. The method includes: connecting a system fixed loop connector located at a first end of the flexible loop to a fixed loop connection portion of a centrifuge to fix the first end of the flexible loop so that it rotates integrally with the centrifuge; connecting a filler loop connector located at a second end of the flexible loop opposite to the first end to a loop connection region of a filler, thereby applying a torsional force based on the twisting of the flexible loop to the filler via the filler loop connector; and moving the flexible loop in the rotational direction to a loop rotation positioning guide located in the centrifuge. In at least one exemplary embodiment, the flexible loop may engage with a loop torsion support bearing located in a channel formed by the loop rotation positioning guide, the loop torsion support bearing supporting the flexible loop. In at least one exemplary embodiment, a loop capture arm may contact the flexible loop when rotating it to guide it into the channel and 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 stopper plate to prevent the flexible loop from over-rotating beyond the channel. In at least one exemplary embodiment, a loop storage bracket positioned coplanar with the loop rotation positioning guide and located on the centrifuge may further capture and hold the flexible loop.

[0020] In at least one exemplary embodiment, the present disclosure provides a soft cassette, the soft cassette comprising: a first cassette port; a second cassette port; a DC lumen fluidly connected to the first and second cassette ports; a drip chamber, the drip chambers being arranged toward each other within the DC lumen such that fluid passing through the DC lumen passes through the drip chambers; and a fluid flow bypass path, the fluid flow bypass path being fluidly connected to the DC lumen adjacent to the first cassette port between the first cassette port and the drip chambers, and fluidly connected to the DC lumen adjacent to the second cassette port between the second cassette port and the drip chambers, such that fluid flowing through the fluid flow bypass path bypasses the drip chambers. In at least one exemplary embodiment, the fluid flow bypass path may include a first bypass branch adjacent to the first cassette port and fluidly connected to the DC lumen, and a second bypass branch adjacent to the second cassette port and fluidly connected to the DC lumen. In at least one exemplary embodiment, the fluid flow bypass path may further include a fluid pressure ring positioned between the first and second bypass branches and fluidly connected to these bypass branches. In at least one exemplary embodiment, the DC lumen may have a first flexible region positioned between a first connection to the first bypass branch and the drip chamber, the first flexible region enabling a first fluid control valve to close the DC lumen. In at least one exemplary embodiment, the DC lumen may have a second flexible region located between the second connection to the second bypass branch and the drip chamber, the second flexible region allowing a second fluid control valve to close the DC lumen. In at least one exemplary embodiment, the DC lumen includes a third flexible region located within the first bypass branch, the third flexible region allowing a draw-in fluid control valve to close the first bypass branch.In at least one exemplary embodiment, the first cassette port may be fluid-connected to a cassette inlet tube that moves fluid from the donor to the soft cassette or from the soft cassette to the donor, and the second cassette port may be fluid-connected to a loop inlet tube that moves fluid from the soft cassette to a centrifuge or from the centrifuge to the soft cassette. In at least one exemplary embodiment, when drawing fluid from the donor, the fluid may pass through the fluid flow bypass path. In at least one exemplary embodiment, when delivering fluid to the donor, the fluid may pass through the DC lumen. In at least one exemplary embodiment, when drawing fluid from the donor in the next draw, some of the fluid previously delivered to the donor through the DC lumen may be retained in the drip chamber as the fluid passes through the fluid flow bypass path. In at least one exemplary embodiment, the soft cassette may be part of a blood component collection set. In at least one exemplary embodiment, the blood component collection set may be part of an apheresis system.

[0021] In at least one exemplary embodiment, the present disclosure provides a blood component collection set. The blood component collection set 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 having a first cassette port fluidly connected to the cassette inlet tube, a second cassette port fluidly connected to the loop inlet tube, a DC lumen fluidly connected to the first and second cassette ports, a drip chamber comprising drip chambers arranged mutually within the DC lumen such that fluid passing through the DC lumen passes through the drip chamber, and a fluid flow bypass path comprising a fluid flow bypass path fluidly connected to the DC lumen adjacent to the first cassette port between the first cassette port and the drip chamber, and a fluid flow bypass path fluidly connected to the DC lumen adjacent to the second cassette port between the second cassette port and the drip chamber, such that fluid flowing through the fluid flow bypass path bypasses the drip chamber. In at least one exemplary embodiment, the fluid flow bypass path may include a first bypass branch adjacent to the first cassette port and fluidly connected to the DC lumen, a second bypass branch adjacent to the second cassette port and fluidly connected to the DC lumen, and a fluid pressure ring positioned between the first and second bypass branches and fluidly connected to these bypass branches. In at least one exemplary embodiment, the DC lumen comprises a first flexible region located between a first connection to the first bypass branch and the drip chamber, the first flexible region enabling a first fluid control valve to close the DC lumen; the DC lumen comprises a second flexible region located between a second connection to the second bypass branch and the drip chamber, the second flexible region enabling a second fluid control valve to close the DC lumen; and the DC lumen comprises a third flexible region located within the first bypass branch, the third flexible region enabling a draw-in fluid control valve to close the first bypass branch.In at least one exemplary embodiment, when fluid is drawn from the donor, the first and second fluid control valves may be closed to block the DC lumen, and the draw-in fluid control valve may be opened to allow whole blood to pass through the fluid flow bypass path. In at least one exemplary embodiment, when fluid is delivered to the donor, the first and second fluid control valves may be opened to allow fluid to pass through the DC lumen, and the draw-in fluid control valve may be closed to block the fluid flow bypass path. In at least one exemplary embodiment, when fluid is drawn from the donor in the next draw-in, some of the fluid previously delivered to the donor through the DC lumen may be retained in the drip chamber as the fluid passes through the fluid flow bypass path.

[0022] In at least one exemplary embodiment, the present disclosure provides a method for moving fluid through a soft cassette. The method comprises the steps of providing a soft cassette, the soft cassette comprising: a first cassette port fluid-connected to a cassette inlet tube; a second cassette port fluid-connected to a loop inlet tube; a DC lumen fluid-connected to the first and second cassette ports; a drip chamber, which is arranged in relation to the DC lumen such that fluid passing through the DC lumen passes through the drip chamber; and a fluid flow bypass path, which is fluid-connected to the DC lumen adjacent to the first cassette port between the first cassette port and the drip chamber, and fluid-connected to the DC lumen adjacent to the second cassette port between the second cassette port and the drip chamber, such that fluid flowing through the fluid flow bypass path bypasses the drip chamber. In at least one exemplary embodiment, when drawing whole blood from a donor, the method includes the steps of receiving whole blood from the cassette inlet tube at a first cassette port fluid-connected to the cassette inlet tube, moving the whole blood through the fluid flow bypass path to the second cassette port, and preventing the whole blood from moving through the DC lumen. In at least one exemplary embodiment, when returning red blood cells to the donor, the method includes the steps of receiving red blood cells from the loop inlet tube at a second cassette port fluid-connected to the loop inlet tube, moving the red blood cells through the DC lumen and the drip chamber to the first cassette port, and preventing the red blood cells from moving through the fluid flow bypass path. In at least one exemplary embodiment, when drawing fluid from the donor in a subsequent draw, some of the previous fluid may be sent to the donor through the DC lumen, or when returning red blood cells to the donor.

[0023] In at least one exemplary embodiment, the Disclosure provides an apheresis system comprising a chamber configured to receive a centrifuge assembly and a movable loop holder. The movable loop holder comprises a loop holder body having a loop connecting portion configured to interact with a flexible loop received by the centrifuge assembly. The movable loop holder is configured to move between a first position and a second position, in which the movable loop holder is at a first distance from the centrifuge assembly, and in the second position, the movable loop holder is at a second distance from the centrifuge assembly, the second distance being greater than the first distance. In at least one exemplary embodiment, when the movable loop holder is in the first position, the centrifuge assembly may be prevented from moving from an operating state to a mounted state, and when the movable loop holder is in the second position, the centrifuge assembly may be able to move from the operating state to the mounted state. In at least one exemplary embodiment, the centrifuge assembly may comprise a first portion and a second portion. The second portion may be movable between an open position and a closed position relative to the first portion. In the mounted state, the second portion may be in the open position, and in the operating state, the second portion may be in the closed position. In at least one exemplary embodiment, in the second position, a clearance may exist between the moving loop holder and the centrifuge assembly, allowing the second portion to move between the open position and the closed position. In at least one exemplary embodiment, the second portion may be connected to the first portion via a hinge, and the trajectory of the movement of the second portion between the open position and the closed position may exhibit an arc shape. In at least one exemplary embodiment, in the first position, the moving loop holder may be closer to the first side of the housing defining the chamber than when it is in the second position, and in the second position, the moving loop holder may be closer to the second side of the housing than when it is in the first position.In at least one exemplary embodiment, the loop connection portion may include a connector lock portion configured to engage with the connector of the flexible loop. In at least one exemplary embodiment, the connector lock portion may include a connector lock wheel configured to change the size of the loop connection portion by moving relative to a flange. In at least one exemplary embodiment, in the first position, the flexible loop may be locked in a predetermined position relative to the loop holder body.

[0024] In at least one exemplary embodiment, the Disclosure provides an apheresis system comprising a chamber, a centrifuge assembly disposed within the chamber, and a movable loop holder disposed within the chamber. The centrifuge assembly comprises a lower housing portion and an upper housing portion. The upper housing portion is movable relative to the lower housing portion. The movable loop holder comprises a loop holder body and a loop connection portion disposed at the end of the loop holder body. The loop connection portion is configured to interact with a flexible loop extending from the centrifuge assembly. The movable loop holder is configured to move between an extended position and a retracted position, in the extended position, the movable loop holder is at a first distance from the centrifuge assembly and the upper housing portion is prevented from moving relative to the lower housing portion; in the retracted position, the movable loop holder is at a second distance from the centrifuge assembly and the upper housing portion is allowed to move relative to the lower housing portion. In at least one exemplary embodiment, in the retracted position, a clearance may exist between the movable loop holder and the centrifuge assembly, allowing the upper housing portion to move between an open and closed position relative to the lower housing portion. In at least one exemplary embodiment, the upper housing portion may be connected to the lower housing portion via a hinge, and the trajectory of the movement of the upper housing portion between the open and closed positions may exhibit an arc shape. In at least one exemplary embodiment, in the extended position, the movable loop holder may be closer to the first side of the housing defining the chamber than in the retracted position, and in the retracted position, the movable loop holder may be closer to the second side of the housing than in the extended position. In at least one exemplary embodiment, the loop connection portion may include a connector lock portion configured to engage with the connector of the flexible loop.In at least one exemplary embodiment, the connector lock portion may include a connector lock wheel configured to change the size of the loop connection portion by moving relative to the flange. In at least one exemplary embodiment, in the first position, the flexible loop may be locked in a predetermined position relative to the loop holder body.

[0025] In at least one exemplary embodiment, the Disclosure provides a method for mounting a centrifuge filler into an apheresis system. The method includes the step of moving a movable loop holder, which is located in a centrifuge chamber, from an extended position to a retracted position. A centrifuge assembly is also located in the centrifuge chamber. The movable loop holder comprises a loop holder body and a loop connecting portion located at the end of the loop holder body. The loop connecting portion is configured to interact with a flexible loop extending from the centrifuge assembly. In the extended position, the movable loop holder is at a first distance from the centrifuge assembly, and in the retracted position, the movable loop holder is at a second distance from the centrifuge assembly. The second distance is greater than the first distance. The method also includes the step of moving an upper housing portion of the centrifuge assembly from a closed position to an open position relative to a lower housing portion, wherein in the retracted position, a clearance exists between the movable loop holder and the centrifuge assembly, allowing the upper housing portion to move between the open and closed positions. The method also includes the steps of bringing the collection bladder, including the flexible loop, into contact with an exposed portion of the centrifuge chamber; moving the upper housing portion from the open position to the closed position to accommodate at least a portion of the collection bladder; and / or moving the movable loop holder from the retracted position to the extended position. In at least one exemplary embodiment, the movable loop holder may further include a release latch. The release latch may engage to move the movable loop holder from the extended position to the retracted position, or from the retracted position to the extended position. In at least one exemplary embodiment, the upper housing portion may be connected to the lower housing portion via a hinge, and the trajectory of the movement of the upper housing portion between the open position and the closed position may exhibit an arc shape.In at least one exemplary embodiment, in the extended position, the movable loop holder may be closer to the first side of the housing that defines the centrifuge chamber than when in the retracted position, and in the retracted position, the movable loop holder may be closer to the second side of the housing than when in the extended position.

[0026] The present disclosure provides many advantages depending on the particular aspects, embodiments, and / or configurations. For example, in at least one exemplary embodiment, by returning unnecessary blood components to the donor while maintaining the rotational speed of the centrifuge, the time of the apheresis procedure can be shortened, for example, by about 30% or more. This efficiency improvement enables faster and more comfortable donor blood donation. With a faster donor blood donation time, a donor blood donation center can obtain more donor blood donations in a typical day, increasing productivity and revenue. Further, if the donor blood donation is faster, the donor is more likely to return for another donor blood donation. If the donor blood donation is faster, the donor blood donation center can also attract donors who are using other donor blood donation centers with slower donor blood donation speeds.

[0027] Further applicable ranges will become apparent from the description provided herein. The descriptions and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.

[0028] The drawings in this specification are for the purpose of illustrating only selected embodiments and are not intended to limit the scope of the present disclosure, which is not all possible implementations.

Brief Description of the Drawings

[0029] [Figure 1] FIG. 1 is a perspective view of the operating environment of an apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 2A] FIG. 2A is a perspective view of the apheresis system shown in FIG. 1. [Figure 2B] Figure 2B is a first detailed perspective view of a pump in an apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 2C] Figure 2C is a second detailed perspective view of a pump in an apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 2D] Figure 2D is a detailed perspective view of a fluid valve control system according to at least one exemplary embodiment of the present disclosure. [Figure 3A] Figure 3A is a detailed perspective view of a disposable soft cassette assembly according to at least one embodiment of the present disclosure. [Figure 3B] Figure 3B is a perspective view of a disposable soft cassette assembly according to at least one embodiment of the present disclosure. [Figure 3C] Figure 3C is an elevation cross-sectional view along line 3C in Figure 3B, according to at least one exemplary embodiment of the present disclosure. [Figure 3D] Figure 3D is an elevation cross-sectional view along line 3D in Figure 3B, according to at least one exemplary embodiment of the present disclosure. [Figure 4A] Figure 4A is a perspective view of a centrifuge assembly in an apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 4B] Figure 4B is a front perspective view of the centrifuge assembly shown in Figure 4A. [Figure 4C] Figure 4C is a rear perspective view of the centrifuge assembly shown in Figure 4A. [Figure 4D] Figure 4D is a schematic cross-sectional view of a centrifuge assembly in a closed state according to at least one exemplary embodiment of the present disclosure. [Figure 4E] Figure 4E is a schematic cross-sectional view of a partially open centrifuge assembly according to at least one exemplary embodiment of the present disclosure. [Figure 4F] Figure 4F is a schematic cross-sectional view of an open centrifuge assembly according to at least one exemplary embodiment of the present disclosure. [Figure 4G]Figure 4G is a perspective view of a filler for a centrifuge according to at least one exemplary embodiment of the present disclosure. [Figure 4H] Figure 4H is a plan view of a filler for a centrifuge according to at least one exemplary embodiment of the present disclosure. [Figure 4I] Figure 4I is a schematic plan view of a substantially helical receiving channel according to at least one exemplary embodiment of the present disclosure. [Figure 4J] Figure 4J is an elevation cross-sectional view along line 4J in Figure 4H. [Figure 4K] Figure 4K is a detailed cross-sectional view of a portion of a channel in a filler according to at least one exemplary embodiment of the present disclosure. [Figure 4L] Figure 4L shows different states of the fluid collection bladder positioned within the channel in the filler of Figure 4K. [Figure 5A] Figure 5A is a diagram of a fluid component collection set including a fluid component collection loop according to at least one exemplary embodiment of the present disclosure. [Figure 5B] Figure 5B is a diagram of a fluid component collection loop including a fluid component collection bladder according to at least one exemplary embodiment of the present disclosure. [Figure 5C] Figure 5C is a cross-sectional view of a fluid component collection bladder according to at least one exemplary embodiment of the present disclosure. [Figure 5D] Figure 5D is another cross-sectional view of a fluid component collection bladder according to at least one exemplary embodiment of the present disclosure. [Figure 5E] Figure 5E is a perspective view of a bent fluid component collection loop according to at least one exemplary embodiment of the present disclosure. [Figure 5F] Figure 5F is a perspective view of a mounted fluid component collection loop according to at least one exemplary embodiment of the present disclosure. [Figure 5G] Figure 5G is a perspective view of a fluid component collection loop mounted within a filler, according to at least one exemplary embodiment of the present disclosure. [Figure 5H]Figure 5H is a perspective view of a fluid component collection loop mounted within a filler according to at least one exemplary embodiment of the present disclosure. [Figure 6A] Figure 6A is a schematic cross-sectional view of a centrifuge assembly in a first loop-mounted state according to at least one exemplary embodiment of the present disclosure. [Figure 6B] Figure 6B is a schematic cross-sectional view of a centrifuge assembly in a second loop-mounted state according to at least one exemplary embodiment of the present disclosure. [Figure 6C] Figure 6C is a schematic cross-sectional view of a centrifuge assembly in a third loop-mounted state according to at least one exemplary embodiment of the present disclosure. [Figure 7A] Figure 7A is a schematic plan view of a centrifuge assembly with a loop mounted, according to at least one exemplary embodiment of the present disclosure. [Figure 7B] Figure 7B is a schematic plan view of a centrifuge assembly in operation according to at least one exemplary embodiment of the present disclosure. [Figure 8] Figure 8 is a functional diagram of one embodiment of an apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 9] Figure 9 is a block diagram of the electrical system of an apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 10] Figure 10 is another block diagram of the electrical system of an apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 11] Figure 11 is another block diagram of the electrical system of an apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 12A] Figure 12A is a flowchart of a method according to at least one exemplary embodiment of the present disclosure. [Figure 12B] Figure 12B is a diagram of an apheresis system with a scanner according to at least one exemplary embodiment of the present disclosure. [Figure 12C]Figure 12C is a diagram of a bottle according to at least one exemplary embodiment of the present disclosure. [Figure 12D] Figure 12D is a diagram of a graphical user interface according to at least one exemplary embodiment of the present disclosure. [Figure 13A] Figure 13A is an isometric view of a plasma collection bottle holder according to at least one exemplary embodiment of the present disclosure. [Figure 13B] Figure 13B is a flowchart according to at least one exemplary embodiment of the present disclosure. [Figure 14A] Figure 14A is a perspective view of a mobile loop holder of an apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 14B] Figure 14B is a partial view of the movable loop holder shown in Figure 14A. [Figure 14C] Figure 14C is an elevation cross-sectional view along line 14C shown in Figure 14B. [Figure 14D] Figure 14D is a partial view of a movable loop holder in an extended position according to at least one exemplary embodiment of the present disclosure. [Figure 14E] Figure 14E is a partial view of a movable loop holder in a retracted position according to at least one exemplary embodiment of the present disclosure. [Figure 14F] Figure 14F is a partial view of the movable loop holder in the retracted position and the lid of the centrifuge assembly of the apheresis system in the open position, according to at least one exemplary embodiment of the present disclosure. [Figure 15A] Figure 15A is a perspective view of a load cell assembly according to at least one exemplary embodiment of the present disclosure. [Figure 15B] Figure 15B is an exploded perspective view of the load cell assembly of Figure 15A according to at least one exemplary embodiment of the present disclosure. [Figure 15C] Figure 15C is a top perspective view of the mounting plate of the load cell assembly shown in Figure 15A, according to at least one exemplary embodiment of the present disclosure. [Figure 15D]Figure 15D is a bottom perspective view of the mounting plate of Figure 15C according to at least one exemplary embodiment of the present disclosure. [Figure 15E] Figure 15E is a perspective view of the bracket of the load cell assembly shown in Figure 15A, according to at least one exemplary embodiment of the present disclosure. [Figure 15F] Figure 15F is a perspective view of a load cell in the load cell assembly of Figure 15A, according to at least one exemplary embodiment of the present disclosure. [Figure 15G] Figure 15G is a perspective view of the load interface plate of the load cell assembly shown in Figure 15A, according to at least one exemplary embodiment of the present disclosure. [Figure 15H] Figure 15H is a perspective view of the overload support bar of the load cell assembly shown in Figure 15A, according to at least one exemplary embodiment of the present disclosure. [Figure 15I] Figure 15I is a partial cross-sectional view of the load cell assembly of Figure 15A in an engaged state, according to at least one exemplary embodiment of the present disclosure. [Figure 15J] Figure 15J is a partial cross-sectional view of the load cell assembly of Figure 15A in a disengaged state with a portion of the first magnet cut out, according to at least one exemplary embodiment of the present disclosure. [Figure 15K] Figure 15K is a side view of the cradle of the load cell assembly shown in Figure 15A, according to at least one exemplary embodiment of the present disclosure. [Figure 15L] Figure 15L is a front view of the cradle of Figure 15K according to at least one exemplary embodiment of the present disclosure. [Figure 15M] Figure 15M is a perspective view of the container in the cradle of Figure 15K according to at least one exemplary embodiment of the present disclosure. [Figure 16A] Figure 16A is a flowchart of a method according to at least one exemplary embodiment of the present disclosure. [Figure 16B] Figure 16B is a diagram of a network-connected apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 16C] Figure 16C is a diagram of a graphical user interface according to at least one exemplary embodiment of the present disclosure. [Figure 16D] Figure 16D is a block diagram of a computing system according to at least one exemplary embodiment of the present disclosure. [Figure 17A] Figure 17A is a flowchart of a method according to at least one exemplary embodiment of the present disclosure. [Figure 17B] Figure 17B is a diagram of an apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 17C] Figure 17C is a diagram of an output device according to at least one exemplary embodiment of the present disclosure. [Figure 17D] Figure 17D is a diagram of an output device according to at least one exemplary embodiment of the present disclosure. [Figure 17E] Figure 17E is a diagram of an output device according to at least one exemplary embodiment of the present disclosure. [Figure 18A] Figure 18A is an exploded perspective view of an apheresis system including a modular maintenance sled member according to at least one exemplary embodiment of the present disclosure. [Figure 18B] Figure 18B is a schematic elevation cross-sectional view of a modular maintenance warp member disengaged from the base of an apheresis system, according to at least one exemplary embodiment of the present disclosure. [Figure 18C] Figure 18C is a bottom perspective view of the return pump assembly of the apheresis system of Figure 18A, according to at least one exemplary embodiment of the present disclosure. [Figure 18D] Figure 18D is a schematic elevation cross-sectional view of the modular maintenance warp member of Figure 18C, engaged with the base of an apheresis system, according to at least one exemplary embodiment of the present disclosure. [Figure 18E] Figure 18E is a flowchart illustrating a method for maintaining an apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 19A]Figure 19A is a perspective view of a collection bottle according to at least one exemplary embodiment of the present disclosure. [Figure 19B] Figure 19B is an elevation view of the collection bottle of Figure 19A, positioned within the plasma collection cradle of an apheresis system according to at least one exemplary embodiment of the present disclosure. [Figure 19C] Figure 19C is a perspective view of the collection bottle canister shown in Figure 19A. [Figure 19D] Figure 19D is a top-down perspective view of the lid of the collection bottle shown in Figure 19A. [Figure 19E] Figure 19E is a bottom view of the lid of the collection bottle shown in Figure 19A. [Figure 19F] Figure 19F is a partial cross-sectional view of the collection bottle of Figure 19A before collection (i.e., before use) according to at least one exemplary embodiment of the present disclosure. [Figure 19G] Figure 19G is a partial view of the collection bottle of Figure 19A after collection (i.e., after use) according to at least one exemplary embodiment of the present disclosure. [Figure 19H] Figure 19H is an elevation view of a collection bottle transport package including a row of filled (i.e., post-collection) collection bottles, according to at least one exemplary embodiment of the present disclosure. [Figure 19I] Figure 19I is a side view of the collection bottle of Figure 19A, positioned within a collection cradle, according to at least one exemplary embodiment of the present disclosure. [Figure 19J] Figure 19J is a perspective view of the collection bottles shown in Figure 19A, placed inside the collection cradle. [Figure 20] Figure 20 is a flowchart of a method according to at least one exemplary embodiment of the present disclosure. [Figure 21A] Figure 21A is a partial perspective view of the apheresis system of Figure 18A according to at least one exemplary embodiment of the present disclosure. [Figure 21B] Figure 21B is an elevation view of a first hanger assembly of the apheresis system shown in Figure 21A, according to at least one exemplary embodiment of the present disclosure. [Figure 21C] Figure 21C is an exploded perspective view of the first hanger assembly of Figure 21B according to at least one exemplary embodiment of the present disclosure. [Figure 21D] Figure 21D is an elevation view of a second hanger assembly of the apheresis system of Figure 21A, according to at least one exemplary embodiment of the present disclosure. [Figure 21E] Figure 21E is an exploded perspective view of the second hanger assembly of Figure 21D according to at least one exemplary embodiment of the present disclosure. [Figure 21F] Figure 21F is a perspective view of the air assembly of the apheresis system of Figure 21A, according to at least one exemplary embodiment of the present disclosure. [Figure 21G] Figure 21G is a partial perspective view of the centrifuge housing of the apheresis system of Figure 21A, according to at least one exemplary embodiment. [Figure 21H] Figure 21H is a perspective view of the centrifuge assembly of the apheresis system of Figure 21A in a cover-locked state, according to at least one exemplary embodiment of the present disclosure. [Figure 21I] Figure 21I is a partially exploded perspective view of the latch engagement plate and latch assembly of the centrifuge shown in Figure 21H, according to at least one exemplary embodiment of the present disclosure. [Figure 21J] Figure 21J is a perspective view of the cover engagement plate of the centrifuge assembly of Figure 21H, according to at least one exemplary embodiment of the present disclosure. [Figure 21K] Figure 21K is a perspective view of the cover of the centrifuge assembly of Figure 21H according to at least one exemplary embodiment of the present disclosure. [Figure 21L] Figure 21L is a perspective view of the base of the centrifuge assembly of Figure 21H according to at least one exemplary embodiment of the present disclosure. [Figure 21M] Figure 21M is a partial bottom perspective view of the centrifuge assembly of Figure 21H in a latched state, according to at least one exemplary embodiment of the present disclosure. [Figure 21N]Figure 21N is a partial bottom perspective view of the centrifuge assembly of Figure 21M in the unlocked state, according to at least one exemplary embodiment of the present disclosure. [Figure 21O] Figure 21O is a perspective view of the compressor assembly of Figure 21H in the unlocked cover state, according to at least one exemplary embodiment of the present disclosure. [Figure 22A] Figure 22A is a flowchart of a method according to at least one exemplary embodiment of the present disclosure. [Figure 22B] Figure 22B is a flowchart of a method according to at least one exemplary embodiment of the present disclosure. [Figure 22C] Figure 22C shows a centrifuge chamber according to at least one exemplary embodiment of the present disclosure. [Figure 23A] Figure 23A is an elevation cross-sectional view of a deflection-based tube condition sensor according to at least one exemplary embodiment of the present disclosure. [Figure 23B] Figure 23B is a perspective view of the deflection block of the tube condition sensor based on the deflection shown in Figure 23A. [Figure 23C] Figure 23C is a schematic diagram that exaggerates the displacement of the deflection block when pressure is applied to the tube portion engaged with the deflection block in Figure 23B. [Figure 23D] Figure 23D is a perspective view of another example of a deflection block for a deflection-based tube condition sensor according to at least one exemplary embodiment of the present disclosure. [Figure 24A] Figure 24A is an elevation view of the blood component collection loop shown in Figure 5A, according to an embodiment of the present disclosure. [Figure 24B] Figure 24B is an elevation view of the blood component collection loop of Figure 24A in a first folded state, according to at least one exemplary embodiment. [Figure 24C] Figure 24C is an elevation view of the blood component collection loop of Figure 24A in a second folded state, according to at least one exemplary embodiment. [Figure 24D]Figure 24D is an elevation view of the blood component collection loop of Figure 24A in a third folded state, according to at least one exemplary embodiment. [Figure 24E] Figure 24E is a bottom view of a blood component collection loop with a folded and packaged bladder, according to at least one exemplary embodiment of the present disclosure. [Figure 24F] Figure 24F is a perspective view of the blood component collection set of Figure 5A, according to at least one exemplary embodiment. [Figure 24G] Figure 24G is a perspective view of the blood component collection loop of Figure 24F without a sealing tape wrap, according to at least one exemplary embodiment. [Figure 24H] Figure 24H is a plan view of the blood component collection loop of Figure 24A according to at least one exemplary embodiment. [Figure 24I] Figure 24I is a perspective view of the filler of the centrifuge assembly of Figure 4B, according to at least one exemplary embodiment of the present disclosure. [Figure 24J] Figure 24J is a detailed schematic plan view of a portion of the collection insertion channel of the centrifuge assembly of Figure 24I, according to at least one exemplary embodiment. [Figure 25A] Figure 25A is a perspective view of another soft cassette according to at least one exemplary embodiment of the present disclosure. [Figure 25B] Figure 25B is a side view of the soft cassette shown in Figure 25A, according to at least one exemplary embodiment of the present disclosure. [Figure 25C] Figure 25C is a front view of the soft cassette of Figure 25A according to at least one exemplary embodiment of the present disclosure. [Figure 25D] Figure 25D is a schematic cross-sectional view of a soft cassette assembly including the soft cassette shown in Figure 25A, according to at least one exemplary embodiment of the present disclosure. [Figure 25E] Figure 25E is a perspective view of the soft cassette assembly of Figure 25D in an open state, according to at least one exemplary embodiment of the present disclosure. [Figure 25F]Figure 25F is a partial cross-sectional view of the soft cassette of Figure 25A in a first pressure state according to at least one exemplary embodiment of the present disclosure. [Figure 25G] Figure 25G is a partial cross-sectional view of the soft cassette of Figure 25A in a second pressure state according to at least one exemplary embodiment of the present disclosure. [Figure 25H] Figure 25H is an exploded view of the soft cassette of Figure 25A according to at least one exemplary embodiment of the present disclosure. [Figure 25I] Figure 25I is another exploded view of the soft cassette of Figure 25A, according to at least one exemplary embodiment of the present disclosure. [Figure 25J] Figure 25J is a flowchart showing a method for manufacturing the soft cassette shown in Figure 25A according to at least one exemplary embodiment of the present disclosure. [Figure 25K] Figure 25K is a partial cross-sectional view of the soft cassette of Figure 25A showing the valve region according to at least one exemplary embodiment of the present disclosure. [Figure 25L] Figure 25L is a detailed cross-sectional view of the valve region of Figure 25K according to at least one exemplary embodiment of the present disclosure. [Figure 25M] Figure 25M is a schematic diagram of another soft cassette according to at least one exemplary embodiment of the present disclosure. [Figure 26A] Figure 26A is a perspective view of a packaged isolation set according to at least one exemplary embodiment of the present disclosure. [Figure 26B] Figure 26B is an elevation view of the separation set of Figure 26A in a package configuration according to at least one exemplary embodiment of the present disclosure. [Figure 26C] Figure 26C is a schematic diagram of a separation assembly including the separation set of Figure 26A, according to at least one exemplary embodiment of the present disclosure. [Figure 26D] Figure 26D is a schematic diagram of an apheresis system, including a properly installed component collection assembly, according to at least one exemplary embodiment of the present disclosure. [Figure 26E]Figure 26E is a partial perspective view of the valve housing of the apheresis system of Figure 26D, according to at least one exemplary embodiment of the present disclosure. [Figure 26F] Figure 26F is a schematic diagram of an apheresis system including a poorly installed component collection assembly, according to at least one exemplary embodiment of the present disclosure. [Figure 26G] Figure 26G is a schematic diagram of the AC bag of the separation assembly shown in Figure 26C, according to at least one exemplary embodiment of the present disclosure. [Figure 26H] Figure 26H is a schematic diagram of a saline bag in the separation assembly of Figure 26C, according to at least one exemplary embodiment of the present disclosure. [Figure 26I] Figure 26I is a perspective view of a container in the cradle of the apheresis system of Figure 26D, according to at least one exemplary embodiment of the present disclosure. [Figure 26J] Figure 26J is a side view of the container and cradle of Figure 26I according to at least one exemplary embodiment of the present disclosure. [Modes for carrying out the invention]

[0030] The corresponding reference numerals indicate the corresponding parts shown in some of the drawings.

[0031] Exemplary embodiments are described more fully with reference to the accompanying drawings.

[0032] Exemplary embodiments are provided for the sake of completeness of this disclosure and to ensure that the scope is fully conveyed to those skilled in the art. Numerous specific details, such as examples of specific components, apparatus, and methods, are described in order to provide a complete understanding of the embodiments of this disclosure. It will be apparent to those skilled in the art that specific details are not necessary, that the exemplary embodiments may be embodied in many different forms, and that none should be construed as limiting the scope of this disclosure. In some exemplary embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.

[0033] The terms used herein are intended to describe, and not limit, specific exemplary embodiments. Where used herein, the singular forms “a,” “an,” and “the” are intended to include the plural form unless the context clearly indicates otherwise. The terms “comprises,” “comprising,” “including,” and “having” are inclusive and thus specify the existence of the described features, entities, steps, actions, elements, and / or components, but do not exclude the existence or addition of one or more other features, integers, steps, actions, elements, components, and / or sets thereof. The steps, processes, and actions of the methods described herein should not necessarily be construed as requiring execution in a specific order described or illustrated unless specifically identified as the order of execution. It should also be understood that additional or alternative steps may be used.

[0034] When an element or layer is referred to as "on top of," "engaged to," "connected to," or "bonded to" another element or layer, it may be directly on, directly engaged to, directly connected to, or directly bonded to the other element or layer, or an intervening element or layer may exist. On the other hand, when an element is referred to as "directly on top of," "directly engaged to," "directly connected to," or "directly bonded to" another element or layer, there is no intervening element or layer. Other terms used to describe relationships between elements should be interpreted similarly (e.g., "between" vs. "directly between," "adjacent" vs. "directly adjacent," etc.). As used herein, the term "and / or" includes any and all combinations of one or more of the related enumerated items.

[0035] The terms "first," "second," "third," etc., may be used herein to describe various elements, components, regions, layers, and / or sections, but these elements, components, regions, layers, and / or parts should not be limited by these terms. These terms are used solely to distinguish one element, component, region, layer, or part from other regions, layers, or parts. The terms "first," "second," etc., and other numerical terms, when used herein, do not imply order or sequence unless explicitly indicated by the context. Thus, the first element, first component, first region, first layer, or first part described below may also be called the second element, second component, second region, second layer, or second part, without departing from the teaching of the exemplary embodiments.

[0036] Terms indicating spatial relationships, such as “inside,” “outside,” “directly below,” “downward,” “below,” “above,” and “upwards,” are used herein to facilitate explanation when describing the relationship between one element or feature part and other elements or feature parts, as shown in the figures. Terms indicating spatial relationships may be intended to include different orientations of the device in use or operation, in addition to the orientation shown in the figures. For example, if the device in the figure is inverted, an element described as being “below” or “directly below” another element or feature part will be changed accordingly to being “above” that other element or feature part. Therefore, for example, the term “below” may include both upward and downward orientations. The device may be oriented in other directions (e.g., 90-degree rotation or rotation at other angles), and the descriptions of spatial relationships used herein shall be interpreted accordingly.

[0037] Various components are referred to herein as “operably connected.” As used herein, “operably connected” refers to components that are connected together in an operable manner, and includes embodiments in which components are directly connected, as well as embodiments in which other components are positioned between connected components. “Operatively connected” components can be “fluidically connected.” “Fluidally connected” refers to components that are connected together so that fluid can be transported between them. “Fluidally connected” includes embodiments in which other components are positioned between two fluidly connected components, as well as components that are directly connected. Fluidly connected components may include components that do not come into contact with fluid but come into contact with other components in order to operate the system (e.g., a peristaltic pump that pumps fluid through a flexible tube by compressing the outside of the tube).

[0038] As used herein, the term “donor” may mean any person who provides a fluid, such as whole blood, to an apheresis system. The donor may also be a patient who temporarily provides a fluid to the apheresis system, which is processed, treated, manipulated, etc., before being returned to the patient.

[0039] As used herein, the term “automatic” and its variations refer to any process or action that is performed without substantial human input when it is performed. However, even if significant or unsignificant human input is used in the execution of a process or action, the process or action may be automatic if such input is received before the execution of the process or action. Human input is considered significant if it affects how the process or action is performed. Human input that signifies consent to the execution of a process or action is not considered “significant.”

[0040] As used herein, the term “computer-readable medium” refers to any tangible storage device and / or transmission medium involved in providing instructions to a processor for execution. Such mediums can take many forms, but are not limited to non-volatile media, volatile media, and transmission media. Examples of non-volatile media include NVRAM, magnetic disks, or optical disks. Examples of 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 tapes, or any other magnetic media, magneto-optical media, CD-ROMs, any other optical media, punch cards, paper tapes, any other physical media with hole patterns, RAM, PROMs, and EPROMs, FLASH-EPROMs, solid media such as memory cards, any other memory chips or cartridges, carriers as described below, or any other computer-readable media. Digital files or other embedded information archives or sets of archives attached to email are considered distribution media equivalent to tangible storage media. When a 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 similar. Accordingly, this disclosure is considered to include tangible storage media or distribution media on which a software implementation of the disclosure is stored, as well as equivalents and successor media recognized as prior art.

[0041] As used herein, the term “module” refers to any known or subsequently developed hardware, software, firmware, artificial intelligence, fuzzy logic, or combination of hardware and software capable of performing functions associated with such elements.

[0042] The terms “determine,” “calculate,” and “operate” as used herein, and their variations thereof, are to be used interchangeably and include any type of methodology, process, mathematical operation, or technique.

[0043] Embodiments of this disclosure will be described more fully with reference to the accompanying drawings, relating to apheresis methods and systems. The following embodiments are described with respect to the separation of blood components from whole blood. However, these are given for illustrative purposes only. The embodiments are not limited to the following description. The embodiments are intended for use in products, processes, apparatus, and systems for separating any complex fluids. Accordingly, this disclosure is not limited to the separation of blood components from whole blood.

[0044] Figure 1 shows a perspective view of the operating environment 100 of the apheresis system 200 according to at least one exemplary embodiment of the present disclosure. The operating environment 100 includes the apheresis system 200, a donor 102, and one or more connections (e.g., a donor supply tube 104, a cassette inlet tube 108A, an anticoagulant tube 110, etc.) extending from the donor 102 to the apheresis system 200 and / or vice versa. As shown in Figure 1, the donor supply tube 104 is fluidly connected to at least one blood vessel of the donor 102, e.g., a vein, by venipuncture. For example, a cannula connected to the end of the donor supply tube 104 is inserted through the skin of the donor 102 and inserted into a target site, i.e., a vein. This connection provides a venous pathway for blood to flow from the donor 102 to the apheresis system 200 and / or for blood components to flow back to the original donor 102. In at least one exemplary embodiment, the fluid pathways and connection portions may form an extracorporeal tubular circuit of the apheresis system 200.

[0045] Blood supplied from donor 102 flows along donor supply tube 104 through tube connector 106 and into soft cassette assembly 300 along cassette inlet tube 108A. The 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. The apheresis system 200 may include an anticoagulant supply source contained in anticoagulant (AC) bag 114. The anticoagulant is pumped through at least anticoagulant tube 110 and tube connector 106 to prevent blood clotting in the apheresis system 200.

[0046] The anticoagulant may include, but is not limited to, one or more citrates and / or unfractionated heparin. The AC bag 114 and other bags or bottles described herein may be formed from, but are not limited to, one or more of the following: polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone, thermoplastics, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof. The amount of AC in the AC bag 114 may vary based on various factors, including the mass of the donor 102 and the volumetric flow rate of blood from the donor. In one example, the volume in the AC bag 114 is 250-500 mL, but the volume in the AC bag 114 may be greater or less than this volume.

[0047] In at least one exemplary embodiment, the apheresis system 200 may include a plasma collection bottle 122 or container, saline fluid contained in a saline bag 118, and one or more lines or tubes (such as a saline tube 116 or a plasma tube 120) connecting the saline bag 118 and the plasma collection bottle 122 to the extracorporeal tubing circuit of the apheresis system 200 (e.g., a fluid transport tube). The amount of saline fluid provided in the saline bag 118 is 500 to 800 mL, but the volume of the saline bag 118 may be larger or smaller than this volume. An example of the amount of blood component, such as plasma, to be donated may be 880 mL. Therefore, 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 substantially at, adjacent to, or physically close to the bottom of the plasma collection bottle 122 (for example, when the plasma collection bottle 122 is placed in the plasma collection cradle 232C, as shown in Figure 2A). The connection point may include one or more connectors configured to interconnect with the plasma tube 120 for receiving and / or transporting plasma. Placing the connection point at the bottom of the plasma collection bottle 122 allows the plasma contained in the plasma collection bottle 122 to flow back from the plasma tube 120 through the line without trapping air bubbles or the like, as described herein. 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 therefore the plasma collection bottle 122 is not limited to a bottle or bottle-like container.

[0048] Figure 2A shows a perspective view of the apheresis system 200 described in Figure 1. The apheresis system 200 enables a continuous whole blood separation process. In at least one exemplary embodiment, whole blood is collected from donor 102 and supplied substantially continuously to the blood component separator of the apheresis system 200. In the blood component separator, 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 donor 102. Blood is collected from donor 102 and guided to the centrifuge of the apheresis system 200 through the opening 220 of the access panel 224 of the apheresis system 200. In at least one exemplary embodiment, the tubes used in the extracorporeal tubing circuit—a donor supply tube 104, a cassette inlet tube 108A, an inlet tube 108B (also known as the loop inlet tube 108B), an outlet tube 112 (also known as the loop outlet tube 112), a saline tube 116, and a plasma tube 120—together constitute a closed-system sterile disposable system or blood component collection set, as further described below.

[0049] Examples of apheresis systems, plasmapheresis systems, and other separation systems that may be used in conjunction with embodiments of the present disclosure (such as the apheresis system 200) include, but are not limited to, the SPECTRA OPTIA® apheresis system, the COBE® spectral apheresis system, and the TRIMA ACCEL® automated blood collection system (these systems are manufactured by Terumo BCT in Lakewood, Colorado).

[0050] The operation of various pumps, valves, and blood component separators or centrifuges may be controlled by one or more processors included in the apheresis system 200, and preferably by multiple embedded computer processors that are part of a computer system. The computer system may include components that allow a user to interface with the computer system, including, for example, memory and storage devices (RAM, ROM (e.g., CD-ROM, DVD), magnetic drives, optical drives, flash memory, etc.), communication / network devices (e.g., wired such as modems / network cards, or wireless such as WiFi), input devices such as keyboards, touchscreens, cameras, and / or microphones, and output devices such as displays and audio systems. In at least one exemplary embodiment, to assist the operator of the apheresis system 200 in various aspects of its operation, the blood component separator or centrifuge may include a graphical user interface with a display including an interactive touchscreen.

[0051] The apheresis system 200 may include a housing 204 and / or a structural frame, a cover 210, access panels 224 positioned on the front portion 202 and / or rear portion 206 of the apheresis system 200, and one or more supports 232A-232C. The supports include hooks, rests, cradles, arms, protrusions, plates, and / or other support functional parts for holding, placing, and / or supporting a container or AC bag 114, saline bag 118, plasma collection bottle 122. In at least one exemplary embodiment, the functional parts of the apheresis system 200 are described in relation to a coordinate system 103 and / or one or more axes thereof. The housing 204 may include an apparatus frame (e.g., formed from welded, bolted, and / or connected structural elements, extruded material, beams, etc.) to which one or more panels, such as the cover 210, doors, subassemblies, and / or components, are attached. In at least one exemplary embodiment, at least one panel of the apheresis system 200 may include a mounting surface for a soft cassette assembly 300, one or more pumps such as a draw pump 208, a return pump 212, an anticoagulant (AC) pump 216, and / or a fluid valve control system 228 (e.g., plasma-saline valve control).

[0052] The access panel 224 may include one or more handles, locks, and pivot or hinge shafts 226 (e.g., door hinges, piano hinges, continuous hinges, cleanroom hinges, etc.). In any case, the access panel 224 is selectively opened to allow access to the interior of the apheresis system 200, more specifically, to the blood separation assembly or centrifuge. In at least one exemplary embodiment, the access panel 224 allows access to the interior when attaching and / or removing one or more components of the blood component collection set to the centrifuge. Details of the centrifuge will be described further below with reference to at least Figures 4A to 4L.

[0053] The interior of the apheresis system 200 may be divided into at least a centrifugal separation section and a control section. For example, the centrifugal separation section includes a cavity configured to accommodate a centrifugal separator, a rotary 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 (configured to house or include, for example, a motor controller, a CPU or processor, electronic equipment, wiring, etc.) may be provided by a panel separate from the rigidly fastened panel of the housing 204 and / or the access panel 224.

[0054] In at least one exemplary embodiment, the apheresis system 200 includes a plurality of pumps, such as an intake pump 208, a return pump 212, or an AC pump 216, configured to control the flow of fluid (e.g., blood and / or blood components, anticoagulants, saline solution, etc.) through the apheresis system 200. For example, the apheresis system 200 includes an intake pump 208 that controls blood flow to and / or from the donor 102 to the centrifuge of the apheresis system 200. The intake pump 208 may engage with the portion of the inlet tube 108B that is located between the soft cassette assembly 300 and the centrifuge of the apheresis system 200. In at least one exemplary embodiment, the apheresis system 200 may include a return pump 212 configured to control the flow of separated blood components (e.g., plasma, etc.) from the centrifuge to and / or the reverse flow to the plasma collection bottle 122. In addition to or instead of this, the return pump 212 may control the flow of saline (e.g., supplied from the saline bag 118) throughout the blood component collection set and / or apheresis system 200. The AC pump 216 may engage with a portion of the anticoagulant tube 110 to selectively control the flow of anticoagulant throughout the blood component collection set of the apheresis system 200. As shown in Figure 2A, the draw-in pump 208, the return pump 212, and the AC pump 216 may be at least partially located on top of the cover 210 of the apheresis system 200.

[0055] Figures 2B and 2C show various perspective views of the suction pump 208, return pump 212, or AC pump 216 of the apheresis system 200 according to at least one exemplary embodiment of the present disclosure. The suction pump 208 is shown and described with reference to Figures 2B and 2C, but it should be understood that the other pump assemblies of the apheresis system 200, namely the return pump 212 and the AC pump 216, differ in some details and may operate differently. However, in many cases, the return pump 212 and / or the AC pump 216 may be substantially similar in structure to, or contain similar structural parts to, the suction pump 208 described, if not identical.

[0056] The suction pump 208 may include a pump cover 236 or housing configured to at least partially accommodate the moving elements of the suction pump 208. In at least one exemplary embodiment, the pump cover 236 may include a hinged tube guard door subassembly or tube guard 240 configured to open and close around 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 arranged along the tube guard pivot axis 242. As shown in Figures 2B and 2C, the blood supplied by the donor 102 may be transported or drawn into the centrifuge by the suction pump 208 in a first suction direction, i.e., the centrifuge direction 250A. In addition to or instead of this, blood or other fluid may be transported or drawn into the donor 102 by the suction pump 208 in a donor direction 250B opposite to the centrifuge direction 250A.

[0057] In at least one exemplary embodiment, the intake pump 208 and / or return pump 212, AC pump 216 may be a tube pump, peristaltic pump, diaphragm pump, and / or other pump configured to manipulate the flow of fluid (e.g., blood, blood components, anticoagulant, saline solution, etc.) in at least a portion of the tubing. For example, the intake pump 208, return pump 212, or AC pump 216 may include a motor operably interconnected with the rotating tube contact assembly. During operation, the tubing (e.g., inlet tube 108B, outlet tube 112, anticoagulant tube 110, etc.) is inserted into a lead tube guide 244, a tube pressure block 248, and an end tube guide 252 adjacent to the rotating tube contact head. In at least one exemplary embodiment, the tube pressure block 248 may be moved away from the rotating tube contact head of the intake pump 208, return pump 212, or AC pump 216 to provide a mounting clearance area, or in the opposite direction. The rotating tube contact head comprises a plurality of rotating pressure rollers 268, each roller configured to rotate around its respective pressure roller rotation axis 264. Each of the rotating pressure rollers 268 is positioned between a first rotating pump plate 272A and a second rotating pump plate 272B, in which case the first and second rotating pump plates 272A and 272B are configured to rotate around a pump rotation axis 260. In at least one exemplary embodiment, the rotating pressure rollers 268 may be positioned around the first and second rotating pump plates 272A and 272B.

[0058] One or more of the suction pump 208, return pump 212, and AC pump 216 may, without limitation, include or operate similarly to the Pulsafeeder® Model UX-74130 peristaltic pumps, Pulsafeeder® MEC-O-MATIC series pumps, all manufactured by Pulsafeeder Inc. in Punta Gorda, Florida. Other examples of the suction pump 208, return pump 212, and AC pump 216 include, but are not limited to, the INTEGRA DOSE IT Laboratory peristaltic pumps manufactured by INTEGRA Biosciences AG in Switzerland, and the WELCO WP1200, WP1100, WP1000, WPX1, and / or WPM series peristaltic pumps, all manufactured by WELCO Co., Ltd. in Tokyo, Japan.

[0059] When the tube is mounted on the lead tube guide 244, the tube pressure block 248, and / or the end tube guide 252, at least a portion of the rotating pressure roller 268 engages with, contacts, or presses against the tube positioned between the rotating tube contact head and the tube pressure block 248. As the first rotating plate 272A and the second rotating plate 272B rotate around the pump rotation axis 260, the rotating pressure roller 268 presses against the tube portion between the draw pump 208, the return pump 212, or the AC pump 216 and the tube pressure block 248, and as the rotating pressure roller 268 moves, the fluid inside the tube portion can be reliably moved in a specific direction, such as the centrifuge direction 250A or the donor direction 250B. For example, when the first rotary pump plate 272A and the second rotary pump plate 272B rotate counterclockwise around the pump rotation axis 260, the rotation of the rotary pressure roller 268 pressing the tube between the rotary pressure roller 268 and the tube pressure block 248 can move or pump the fluid toward the centrifuge direction 250A. As another example, when the first rotary pump plate 272A and the second rotary pump plate 272B rotate clockwise around the pump rotation axis 260, the rotation of the rotary pressure roller 268 pressing the tube between the rotary pressure roller 268 and the tube pressure block 248 can move or pump the fluid toward the donor direction 250B. When not actively pumping, the pump 208 is maintained in a state where at least one rotary pressure roller 268 continues to close the inlet tube 108B (normally closed, i.e., NC), or in a state where the rotary pressure roller 268 does not close the inlet tube 108B (normally open, i.e., NO). Therefore, the intake pump 208 can also act as a "valve" to block or allow fluid movement, depending on its state when not in operation. This capability is also possible with the return pump 212 and / or AC216.

[0060] The tube guard 240 and pump cover 236 serve to protect the operator (e.g., a phlebotomist, apheresis technician, etc.) and / or donor 102 from accidental contact with one or more moving parts of the draw pump 208, return pump 212, and AC pump 216. In at least one exemplary embodiment, the tube guard 240 is held in a closed position via one or more guard closing functional parts 254 located on the tube guard 240, lead tube guide 244, tube pressure block 248, and / or end tube guide 252, or arranged to be operationally related thereto. These guard closing functional parts 254 may be magnets housed in the tube guard 240, lead tube guide 244, tube pressure block 248, and / or end tube guide 252. In at least one exemplary embodiment, the draw pump 208, return pump 212, and AC pump 216 may be stopped or not moved / operated when the tube guard 240 is open. In at least one exemplary embodiment, the door closing sensor may be included in the guard closing function portion 254, the lead tube guide 244, the end tube guide 252, and / or the tube pressurizing block 248.

[0061] One or more fluid control valves can be used to control the routing or flow direction of the fluid being transported through the tubing of the apheresis system 200. In at least one exemplary embodiment, the apheresis system 200 includes a plasma-saline valve control system, such as a fluid valve control system 228 positioned adjacent to the saline bag 118 and / or plasma collection bottle 122. The fluid valve control system 228 is shown in a detailed perspective view in Figure 2D.

[0062] As shown in Figure 2D, the outlet tube 112 passes through the return pump 212 and is interconnected with the saline-plasma tube y-connector 280. The saline-plasma tube y-connector 280 allows the outlet tube 112 to be connected to the saline tube 116 line and the plasma tube 120 line. The fluid valve control system 228 may include an air detection sensor 284 located at the first end of the saline-plasma valve housing 276 and surrounding a portion of the outlet tube 112. The air detection sensor 284 may be any optical, ultrasonic, or other type of sensor capable of detecting the presence of fluid or air in the outlet tube 112 and providing a signal to the controller of the apheresis system 200. Examples of the type of air detection sensor 284 include, for example, the SONOCHECK ABD05 manufactured by SONOTEC US Inc., or other similar sensors.

[0063] The saline / plasma valve housing 276 includes a plurality of receiving functional parts (e.g., grooves, channels, receptacles, etc.) that receive the outlet tube 112, the saline tube 116, a portion of the plasma tube 120 and / or the saline / plasma tube y-connector 280. When air is detected in the outlet tube 112, the fluid valve control system 228 selectively activates one or more fluid control valves, such as the plasma flow control valve 286 and the saline flow control valve 288. In at least one exemplary embodiment, detection of air via the air detection sensor 284 signals an operation step and / or triggers a step in a control method as described herein.

[0064] The plasma flow control valve 286 and / or the saline flow control valve 288 may be solenoid valves, linear actuators, pinch valves, clamp valves, tubular valves, and / or other operable valves configured to selectively alter (e.g., block) the fluid passage associated with specific portions of the outlet tube 112, the saline tube 116, and the plasma tube 120. As shown in Figure 2D, the plasma flow control valve 286 may be configured to pinch a portion of the plasma tube 120 that is at least partially housed within the receptive functional portion of the saline-plasma valve housing 276. The saline flow control valve 288 may be configured to pinch a portion of the saline tube 116 that is at least partially housed within the receptive functional portion of the saline-plasma valve housing 276. In any case, the plasma flow control valve 286 and the saline flow control valve 288 include operable and extendable fingers that move from a retracted or partially retracted position to an extended or partially extended position to pinch a portion of the tube housed within the saline-plasma valve housing 276. The plasma flow control valve 286 and the saline flow control valve 288 may pinch the tube completely (for example, completely restrict the flow of fluid through the tube), but it should be understood that the plasma flow control valve 286 and the saline flow control valve 288 may also be partially actuated to a position that partially restricts the flow of fluid in a portion of the tube.

[0065] As should be understood, the intake pump 208, the return pump 212, and the AC pump 216 include other components as described in the specification entitled “Fluid Control and Bypass Functional Components for an Apheresis System,” filed on March 2, 2023, and granted U.S. Patent Application No. 18 / 116,527, with Agent Reference Number 18955-000029-US. The entirety of the aforementioned U.S. Patent Application is expressly incorporated herein by this disclosure.

[0066] First example of a soft cassette with integrated functional components Figure 3A is a partial perspective view of a soft cassette assembly according to at least one exemplary embodiment.

[0067] In at least one exemplary embodiment, a detailed perspective view of a disposable soft cassette assembly 300 according to an embodiment of the present disclosure is shown, as in Figure 3A. The soft cassette assembly 300 includes a base plate 302 and a cassette access door 304 attached to the base plate 302 via at least one hinge 306 and / or a cassette access door latch 308. In at least one exemplary embodiment, the cassette access door 304 is unlocked by acting on the cassette access door latch 308 to rotate the cassette access door 304 around the cassette access door hinge axis 310.

[0068] In at least one exemplary embodiment, the soft cassette assembly 300 may be configured with one or more soft cassette receiving functional parts 312 for at least partially housing and / or positioning the soft cassette 314. The soft cassette 314 may be part of a blood component collection set described herein. For example, the soft cassette 314 may be positioned between the cassette inlet tube 108A and the loop inlet tube 108B of the extracorporeal tubing circuit (see Figure 5A). In at least one exemplary embodiment, the soft cassette 314 comprises one or more functional parts for controlling the flow of blood and / or blood components from the donor 102 (Figure 1) to the apheresis system 200 (Figure 1) and / or vice versa.

[0069] In at least one exemplary embodiment, the soft cassette assembly 300 includes an air detection sensor 316, a fluid sensor 318, and one or more fluid control valves 320A, 320B, 320C configured to control the routing or flow direction of fluid through the soft cassette 314. In at least one exemplary embodiment, these components may be independently embedded in the cassette access door 304, the base plate 302, and / or as part of the housing 204 of the apheresis system 200. Similar to the guard closing function portion 254 described in association with Figures 2B-2C, the soft cassette assembly 300 may include one or more door closing function portions 328. Examples of door closing function portions 328 include, but are not limited to, magnetic catches, projections, tabs and slots, and / or other connecting members. In at least one exemplary embodiment, the door closing function portion 328 may include a pressure contact surface configured to hold or at least partially position the soft cassette 314 within the soft cassette assembly 300.

[0070] In at least one exemplary embodiment, the valves 320A, 320B, 320C may include, but are not limited to, solenoid valves, linear actuators, pinch valves, clamp valves, tubular valves, and / or other actuated valves configured to selectively alter (e.g., block) a fluid passage (e.g., cross-sectional area, etc.) associated with a particular portion of the soft cassette 314.

[0071] In at least one exemplary embodiment, the soft cassette assembly 300 includes a first fluid control valve 320A configured to pinch a portion of the soft cassette 314 adjacent to the cassette inlet tube 108A. A second fluid control valve 320B may be configured to pinch a portion of the soft cassette 314 adjacent to the loop inlet tube 108B. A draw-in fluid control valve 320C may be configured to pinch a portion of the soft cassette 314 along a branch tube extending from a point adjacent to the cassette inlet tube 108A to a point adjacent to the loop inlet tube 108B. In at least one exemplary embodiment, valves 320A, 320B, and 320C each include an operable and extendable finger that moves from a retracted or partially retracted position to an extended or partially extended position to pinch a portion of the soft cassette 314 housed within the soft cassette assembly 300. Valves 320A, 320B, and 320C may completely pinch the flow path within the soft cassette 314 (for example, completely restricting the flow of fluid through this flow path), but it should be understood that valves 320A, 320B, and 320C may also be partially actuated to a position that partially restricts the flow of fluid through a portion of the soft cassette 314.

[0072] In at least one exemplary embodiment, sensors 316, 318 may be one or more of ultrasonic detectors, pressure sensors, magnetic position sensors, and / or similar. In some cases, the fluid sensor 318 may be configured to determine whether fluid is present in the soft cassette 314 based on the position of the magnet relative to a portion of the soft cassette 314. For example, when a portion of the soft cassette 314 is filled with fluid, the magnet is positioned at a first position from the surface of the soft cassette 314. On the other hand, when a portion of the soft cassette 314 is filled with air, the force from the magnet compresses the portion of the soft cassette 314 to a second position closer to the surface of the soft cassette 314 than the first position. In at least one exemplary embodiment, detection of air or fluid by the air detection sensor 316 and the fluid sensor 318 sends a signal to and / or triggers an operation step in a control method as described herein.

[0073] Figure 3B is a perspective view of the soft cassette of the soft cassette assembly of Figure 3A according to at least one exemplary embodiment. Figure 3C is a cross-sectional view of the soft cassette of Figure 3B along line 3C-3C of Figure 3A according to at least one exemplary embodiment. Figure 3D is a cross-sectional view of the soft cassette of Figure 3A along line 3D-3D of Figure 3A according to at least one exemplary embodiment.

[0074] In at least one exemplary embodiment, the soft cassette 314 may be part of a blood component collection set. For example, the soft cassette 314 is a disposable component used in a blood separation method described herein. In at least one exemplary embodiment, the soft cassette 314 may be formed from a substantially flexible and / or pliable material. The flexible material may be chemically inert and / or able to withstand sterilization and cleaning operations, temperatures, and / or processing. The soft cassette 314 may be formed from a thermoplastic material. In at least one exemplary embodiment, the soft cassette 314 may be formed from polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene with vinyl acetate (EVA), rubber, silicone, thermoplastic elastomer, copolymer, and / or a combination thereof. In at least one exemplary embodiment, the soft cassette 314 may be molded, rotomolded, cast, injection molded, or formed from one or more of the aforementioned materials.

[0075] In at least one exemplary embodiment, the soft cassette 314 includes and / or defines a first cassette port 340A (shown in Figures 3B-3C), a second cassette port 340B (shown in Figures 3B-3C), and a DC lumen 350 (shown in Figure 3C) extending between the first and second cassette ports 340A, 340B. In at least one exemplary embodiment, the first and / or second cassette ports 340A, 340B may be configured to receive and / or fluid-couple to one or more tubes of a blood component collection set. In at least one exemplary embodiment, the first cassette port 340A is coupled to a cassette inlet tube 108A, and the second cassette port 340B is coupled to a loop inlet tube 108B. These couplings are airtight and / or fluid-tight. In at least one exemplary embodiment, the first and / or second cassette ports 340A, 340B may be openings located within a soft cassette 314 configured to elastically stretch around the ends of tubes (e.g., cassette inlet tube 108A, loop inlet tube 108B, etc.), or may include such openings.

[0076] In at least one exemplary embodiment, the blood supplied by the donor 102 (shown in Figure 1) may be directed along one or more fluid paths located within the soft cassette 314. In one embodiment, the blood may be directed along the DC lumen 350 from a first cassette port 340A to a second cassette port 340B. In some embodiments, this path may direct the blood through a first chamber or drip chamber 354 of the soft cassette 314. In some embodiments, the blood and / or other fluids returned to the donor 102 may be directed along the DC lumen 350 from a second cassette port 340B to a first cassette port 340A.

[0077] In at least one exemplary embodiment, the soft cassette 314 includes a fluid flow bypass path provided by a first bypass branch 358 (shown in Figures 3B and 3D) having a bypass flow lumen 360 (shown in Figure 3D) fluid-connected to a portion of the DC lumen 350, adjacent to or as part of the first cassette port 340A. In some embodiments, the bypass flow lumen 360 extends from a point in the DC lumen 350 adjacent to the first cassette port 340A, along the first bypass branch 358, through a second chamber or fluid pressure ring 362 (shown in Figures 3B and 3D), to a second bypass branch 364 (shown in Figures 3B and 3D), and then reconnects to the DC lumen 350 at a point adjacent to or as part of the second cassette port 340B. As its name suggests, the bypass flow lumen 364 provides a flow path within the soft cassette 314 that bypasses the drip chamber 354.

[0078] In at least one exemplary embodiment, controlling the flow path within the soft cassette 314, or directing the fluid, involves acting the fluid control valves 320A, 320B, 320C (shown in Figure 3A) of the soft cassette assembly 300 to interact with various flexible regions 370A, 370B, 370C (shown in Figure 3B) to shut off and / or open various portions of the DC lumen 350 and / or bypass flow lumen 360. The first flexible region 370A provides a pinch valve region at a point along the DC lumen 350 between the first cassette port 340A near the first cassette end 372 of the soft cassette 314 and the drip chamber 354. When the first fluid control valve 320A is activated, the valve 320A pinches the DC lumen 350 in this first flexible region 370A, thereby restricting or completely stopping the fluid flow at this point in the soft cassette 314. The second flexible region 370B provides a pinch valve region at a point on the DC lumen 370 between the second cassette port 340B near the second cassette end 374 (e.g., the end opposite to the first cassette end 372) and the drip chamber 354. When the second fluid control valve 320B is activated, the valve 320B pinches the DC lumen 370 in this second flexible region 370B, thereby restricting or completely stopping the fluid flow at this point in the soft cassette 314. To understand this, a third flexible region 370C, positioned adjacent to the fluid pressure ring 362 and along the first bypass branch 358, can provide a pinch valve region at a point on the bypass flow lumen 360. When the draw-in fluid control valve 320C is actuated, the valve 320C can pinch the bypass flow lumen 360 in this third flexible region 370C, thereby restricting or completely stopping the flow of fluid through the bypass flow lumen 360.

[0079] In at least one exemplary embodiment, as shown in the elevation section of Figure 3C along a plane extending through the DC lumen 350 and the drip chamber 354, the DC lumen 350 extends from the first cassette port 340A through the chamber volume 376 of the drip chamber 354 to the second cassette port 340B. The DC lumen 350 is formed as a fluid passage extending inside the first tube section 378, the chamber volume 376, and the second tube section 379 of the soft cassette 314.

[0080] In at least one exemplary embodiment, the bypass path of the soft cassette 314 includes a fluid pressure ring 362. Fluid can flow through this fluid pressure ring 362 from the first bypass branch 358 to the second bypass branch 364 and / or vice versa. In at least one exemplary embodiment, a pressure diaphragm 380 may be formed in the material of the soft cassette 314 in a region inside or adjacent to the fluid pressure ring 362. The fluid pressure ring 362 and the pressure diaphragm 380 are shown in the elevation section of Figure 3D, taken along a plane extending through the fluid pressure ring 362 and portions of the first and second bypass branches 358, 364.

[0081] In at least one exemplary embodiment, the pressure diaphragm 380 provides a contact surface or measuring surface to a fluid sensor 318 for detecting whether the fluid pressure ring 362 and / or the bypass flow lumen 360 contain a predetermined amount of fluid, a predetermined amount of air, and / or a combination thereof. As previously mentioned, when fluid fills a portion of the fluid pressure ring 362, the fluid can provide greater resistance to movement than when the fluid pressure ring 362 is filled with air. This difference in resistance is measured by the fluid sensor 316, which in turn determines the amount and / or type of fluid (e.g., air, blood, etc.) in the bypass flow lumen 360 and / or the fluid pressure ring 362.

[0082] Example of a centrifuge assembly Figure 4A is a perspective view of an exemplary centrifuge assembly 400 used in an apheresis system 200 according to at least one exemplary embodiment of the present disclosure. The centrifuge assembly 400 may be located within the internal space of the apheresis system 200. The internal space may be at least partially enclosed by one or more elements of the housing 204 and / or the centrifuge chamber. Access to the internal space and the centrifuge assembly 400 may be provided by an access panel 224 located in the front portion 202 of the apheresis system 200. For example, in Figure 4A, the access panel 224 is shown in an open position, open along a hinge axis 226. The hinge axis 226 may correspond to a door hinge, a continuous hinge, a cleanroom hinge, and / or other panel hinges.

[0083] The centrifuge assembly 400 is operably mounted inside the apheresis system 200 so that the centrifuge assembly 400 can rotate relative to the housing 204 and / or other elements of the apheresis system 200. One or more parts of the blood component collection set (e.g., the blood component collection set 500 shown in Figures 5A to 5H) are mounted to the centrifuge assembly 400 by routing tubes (e.g., inlet tube 108B and outlet tube 112, etc.) into the internal space of the apheresis system 200 (e.g., through the opening 220 shown in Figure 2A), connecting a portion of the blood component collection loop 520 to the fixed loop connector 402, and inserting the blood component collection bladder 536 into the filler 460. The fixed loop connector 402 maintains the inlet tube 108B and outlet tube 112 in a fixed position and prevents the tubes 108B and 112 from twisting outside the apheresis system 200. In at least one exemplary embodiment, the blood component collection loop 520 may be interconnected with the fixed loop connector 402 via one or more key function parts or positive location features.

[0084] For illustrative purposes, Figures 4B–4C show a centrifuge assembly 400 separated from the apheresis system 200. The centrifuge assembly 400 includes a centrifuge split housing 404 having a lower housing 404A rotatably connected to an upper housing 404B. The upper housing 404B can be opened to provide access for mounting a blood component collection bladder (e.g., a blood component collection set 500 shown in Figures 5A–5H) into the centrifuge assembly 400. In at least one exemplary embodiment, the upper housing 404B rotates around a split housing pivot axis 406 (e.g., configured as a hinge, pin, fastener, shoulder bolt, etc.).

[0085] 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 each other. 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 performed by rotating the upper housing 404B relative to the lower housing 404A around the centrifuge rotation axis 430. In Figures 4B and 4C, the centrifuge split housing 404 is shown in an unlocked state, but it should be understood that the upper housing 404B can be rotated (e.g., counterclockwise) around the centrifuge rotation axis 430 to engage one or more locking tabs 428 or locking elements of the upper housing 404B with locking slots 432 located in the lower housing 404A (e.g., as shown in Figure 4C). When the upper housing 404B is in the unlocked position, it is released or rotated around the split housing pivot axis 406 to mount the blood component collection loop 520 and / or blood component collection bladder 536 onto 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 single unit during centrifugation or blood separation.

[0086] The centrifuge assembly 400 may include at least one clockwise rotation stopper 408A, a counterclockwise rotation stopper 408B, an upper housing clockwise rotation flag 410A, and / or an upper housing counterclockwise rotation flag 410B. In at least one exemplary embodiment, the rotation stoppers 408A, 408B are fixed in the rotational direction with respect to the centrifuge rotation axis 430 of the lower housing 404A. The rotation flags 410A, 410B are mounted on or formed in the upper housing 404B and are configured to contact the respective rotation stoppers 408A, 408B when locking and / or unlocking the two halves of the centrifuge split housing 404 to each other, thereby preventing over-rotation of the upper housing 404B relative to the lower housing 404A. For example, when the upper housing 404B is rotated clockwise or in the unlocking direction around the centrifuge rotation axis 430, a portion of the upper housing clockwise rotation flag 410A may contact the clockwise rotation stopper 408A to prevent further rotation in the clockwise direction. In addition to or instead of this, when the upper housing 404B is rotated counterclockwise or in the locking direction around the centrifuge rotation axis 430, a portion of the upper housing counterclockwise rotation flag 410B may contact the counterclockwise rotation stopper 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. The locking elements are configured to hold half of the centrifuge split housing 404 in a locked state while these locking elements are engaged.

[0087] 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 to rotate the upper housing 404B relative to the lower housing 404A around a split housing pivot axis 406. The pull ring 412 has an opening through which a user can insert a finger and apply a tensile force to the upper housing 404B, which is unlocked in the rotational direction.

[0088] The centrifuge assembly 400 may include a rotor motor assembly 414 that is controlled and / or powered via electrically interconnected electrical cables 420. The electrical cables 420 include connectors that are attached to a controller, processor, and / or power supply. The electrical cables 420 can transmit 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 as part of an electric motor that rotates the entire centrifuge assembly 400 relative to the apheresis system 200 (e.g., 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) inside the apheresis system 200.

[0089] As described herein, the centrifuge assembly 400 may include one or more functional parts for guiding, housing, and / or positioning elements of a blood component collection set relative to the centrifuge split housing 404. For example, Figure 4B shows a blood component collection loop 520 captured in the operating position within a loop rotation positioning guide 424, which includes a loop capture arm 416. The loop rotation positioning guide 424 includes a plurality of bearings 417 and / or bearing surfaces arranged to at least partially support the blood component collection loop 520 in the operating position. In the operating position, the blood component collection loop 520 is capable of twisting along its length within the range of support provided by the bearings 417 of the loop rotation positioning guide 424. For example, one end of the blood component collection loop 520 is attached and fixed to a fixed loop connection 402 of the apheresis system 200, while the other end of the blood component collection loop 520 is attached to a filler 460 (e.g., an internal rotating component of the centrifuge assembly 400). As the centrifuge assembly 400 rotates during centrifugal operation, the twisting of the blood component collection loop 520 between the fixed loop connector 402 and the connector in 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 direction at an angular velocity twice that of the centrifuge split housing 404. In this example, as the centrifuge split housing 404 rotates counterclockwise around the centrifuge rotation axis 430 at a first angular velocity 1ω, the filler 460 rotates counterclockwise within the centrifuge split housing 404 at a second angular velocity 2ω (e.g., approximately twice the first angular velocity).

[0090] The centrifuge assembly 400 may include one or more balancing functional parts, elements, and / or structures positioned around the centrifuge rotation axis 430 of the centrifuge assembly 400. These balancing functional parts can balance the centrifuge assembly 400 axially so as not to substantially impose vibrations on the apheresis system 200 when the centrifuge assembly 400 is rotated around the centrifuge rotation axis 430. In at least one exemplary embodiment, the centrifuge balance weight 418 is mounted on a part of the centrifuge split housing 404 (e.g., the lower housing 404A and / or the upper housing 404B). This centrifuge balance weight 418 can be custom-tuned for the centrifuge assembly 400, and thus the centrifuge balance weight 418 can be selectively attached to or removed from the centrifuge assembly 400. The tuning of the centrifuge balance weight 418 is calculated and / or experimentally derived, in particular to result in a fully balanced centrifuge assembly 400 when one or more elements of the blood component collection set are attached.

[0091] Figure 4C shows a rear perspective view of a centrifuge assembly 400 according to at least one exemplary embodiment of the present disclosure. Part of the filler 460 is visible through an opening in the upper housing 404B. The blood component collection loop 520 is shown in its initial loop mounting position 520A, in which the first end is interconnected with the filler 460 and the second end is attached and fixed to a fixed loop connection 402 (not shown). The blood component collection loop 520 is shown passing through the loop access clearance 436 of the centrifuge split housing 404. When the blood component collection loop 520 is mounted in the loop mounting position 520A, a portion of the blood component collection loop 520 is partially housed, held, and / or supported by the loop storage bracket 426. The loop storage bracket 426 includes one or more bearings 417 (e.g., roller bearings, ball bearings, needle bearings, etc., and / or assemblies thereof) or bearing surfaces arranged to at least partially support the blood component collection loop 520 as it twists relative to the centrifuge assembly 400. In at least one exemplary embodiment, the blood component collection loop 520 rotates about an axis extending along the length of the flexible loop 524 (e.g., in the installed or mounted situation and / or state, etc.) to allow the flexible loop 524 to rotate relative to the loop rotation positioning guide 424. For example, the loop does not “twist up” but actually rotates or rolls between one or more bearings 417 relative to the loop rotation positioning guide 424 (e.g., support structure). This rotation or twisting, which does not cause the flexible loop 524 to wrap around or entangle, may be referred to herein as a “twist.” This twisting allows the flexible loop 524 to transmit rotational force to the filler 460 without significantly reducing the inner diameter of the lumen of the flexible loop 524. In some cases, the inner diameter of the lumen of the flexible loop 524 does not decrease at all.

[0092] As described above, when the upper housing 404B is rotated from the unlocked position in the rotational direction shown in Figures 4B-4C to the locked position in the rotational direction, the locking tab 428 of the upper housing 404B engages with the locking slot 432 of the lower housing 404A. In addition to or instead of this, when moved to the locked position in the rotational direction, the loop storage bracket 426 rotates together with the blood component collection loop 520 and the upper housing 404B to a position where it is aligned with the loop rotation positioning guide 424 along the loop engagement position 520B. In at least one exemplary embodiment, as the upper housing 404B and the blood component collection loop 520 rotate to the loop engagement position 520B, the loop capture arm 416 can guide the blood component collection loop 520 to the bearing 417 and / or bearing surface of the loop rotation positioning guide 424. Further details regarding the mounting of the blood component collection loop 520 will be described in relation to Figures 6A-7B.

[0093] Figures 4D to 4F show various schematic cross-sectional views passing through the center of the centrifuge assembly 400 (for example, bisecting the centrifuge assembly 400 by the centrifuge rotation axis 430). As previously stated, the centrifuge assembly 400 includes a lower housing 404A which is rotatably attached to the upper housing 404B by a split housing pivot axis 406 or a hinge. The upper housing 404B is attached to an upper housing adapter 440 which is rotatably connected to an upper housing bushing block 442 which is attached to a pull ring 412. In at least one exemplary embodiment, a bearing 417, bush, or bearing surface may be positioned between the upper housing adapter 440 and the upper housing bushing block 442 to allow the upper housing 404B to rotate along the centrifuge rotation axis 430 from a locked position to an unlocked position and vice versa. The pull ring 412 may be fixed to the lower housing 404A in the rotational direction around 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 single integrated structure.

[0094] The filler 460 is mounted and fixed to a filler mandrel 434 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 any case, one or more mandrel support bearings 444 are positioned 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 the centrifuge assembly 400. In at least one exemplary embodiment, the filler mandrel 434 may be held in the working position via at least one retaining nut 438. The filler 460 and the filler mandrel 434 can rotate together with respect to the centrifuge split housing 404.

[0095] Figure 4D shows a schematic cross-sectional view of the centrifuge assembly 400 in a closed state (for example, before the blood component collection loop 520 is attached). When the upper housing 404B is unlocked relative to the lower housing 404A, the operator pulls the pull ring 412 to rotate the entire upper housing 404B and filler 460 around the split housing pivot axis 406. In at least one exemplary embodiment, the upper housing 404B and filler 460 are partially opened by rotating the components in the opening direction 446 around the split housing pivot axis 406. For example, as shown in Figure 4E, which shows the centrifuge assembly 400 in a partially opened state, the upper housing 404B and filler 460 are rotated so that their axes are separated from the lower housing pivot axis 430A. In this position, the filler 460 may be made rotatable around the filler pivot axis 430B. When the lower housing 404A and the upper housing 404B are closed, the lower housing rotation axis 430A and the filler rotation axis 430B are aligned (to coincide or nearly coincide) to form the centrifugal separator rotation axis 430.

[0096] By continuously rotating the upper housing 404B and filler 460 in the open direction 446 (for example, by continuing to pull the pull ring 412) around the y-axis of the split housing pivot axis 406, the upper housing 404B and filler 460 can be rotated approximately 180 degrees from the closed position shown in Figure 4D. As shown in Figure 4F, the centrifuge assembly 400 is in the open or mounted position. In this position, the upper housing 404B and filler 460 can be rotated outside the internal space of the apheresis system 200. For example, at least a portion of the upper housing 404B and / or filler 460 is positioned through the open space of the open access panel 224. In this position, a mounting access area 450 is provided with respect to the loop connection area 454 of the filler 460. As can be understood, when the upper housing 404B is in the open position, the interior of the upper housing 404B and filler 460 is easily accessible. In particular, this arrangement allows the operator to provide sufficient space to attach the blood component collection loop 520 to the filler 460 in the loop connection area 454.

[0097] Referring to Figure 4G, a perspective view of a filler 460 for a centrifuge assembly 400 according to at least one exemplary embodiment of the present disclosure is shown. In at least one exemplary embodiment, the filler 460 is formed from a lightweight material such as plastic, carbon fiber, 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 additive manufacturing machines. In particular, these additive rapid prototyping manufacturing techniques enable more complex geometric shapes of the filler 460 that may not be possible with the use of 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 filler 460 to be manufactured, and / or a material suitable for use in manufacturing.

[0098] The filler 460 includes a loop connection region 454 located substantially at the center of the filler 460. The loop connection region 454 includes one or more key function parts or positive positioning function parts for a portion of the blood component collection loop 520 to engage with. As shown in Figure 4G, the loop connection region 454 includes a first positive positioning function part 478 located along a portion of the central axis of the filler 460. The first positive positioning function part 478 may be a keyway, groove, slot, or other function part for engaging with a fitting function part located on the blood component collection loop 520. In at least one exemplary embodiment, the filler 460 has a second positive positioning function part 480 in the loop connection region 454. The positioning function parts 478, 480 prevent the blood component collection loop 520 from rotating in the loop connection region 454 and / or prevent the blood component collection loop 520 from detaching from the loop connection region 454 of the filler 460.

[0099] In at least one exemplary embodiment, the filler 460 includes a collection insertion channel 466 configured to receive and at least partially accommodate a blood component collection bladder, more specifically, a blood component collection loop 520, of a blood component collection set. The collection insertion channel 466 is configured as a groove, slot, extending substantially spirally outward from the center of the filler 460. In at least one exemplary embodiment, the collection insertion channel 466 follows a substantially spiral path including a first spiral path portion extending outward along the longitudinal direction of the circumference of the collection insertion channel 466 to a substantially constant radius from the center of the filler 460 (for example, with respect to the center of the filler 460). In any case, the path is referred to herein as a spiral path or substantially spiral path. The collection insertion channel 466 begins at a channel inlet 468 near the center of the filler body 464 and ends at a channel end 472 near the point furthest from the center of the filler body 464. As shown in Figures 4G to 4I, the collection insertion channel 466 extends along a substantially helical path 490 that extends from a point near the filler rotation axis 430B to the channel end 472. The substantially helical path 490 includes a channel path curve 476 at a point near or adjacent to the channel end 472. This channel path curve 476 increases the distance of the collection insertion channel 466 from the center of the filler body 464, thereby increasing the centripetal and centrifugal forces at the channel end 472 of the collection insertion channel 466. In at least one exemplary embodiment, this channel path curve 476 corresponds to a critical inlet / outlet port at the maximum radial position in the blood component collection bladder 536, which is at least partially inserted or positioned within the collection insertion channel 466 of the filler 460. In at least one exemplary embodiment, the filler 460 may include one or more filler balancing projections 482 positioned on or near part of the filler body 464. These filler balancing projections 482 can result in a filler 460 that is axially balanced (e.g., balanced around the filler rotation axis 430B), especially when the collection insertion channel 466 contains a blood component collection bladder and fluid (e.g., blood, blood components, etc.).

[0100] Figure 4I is a schematic plan view of a substantially helical receiving channel or collection insertion channel 466 in a filler 460 according to at least one exemplary embodiment of the present disclosure. This schematic plan view shows a first distance R1 of the collection insertion channel 466 from the center of the filler body 464 at a first point along the substantially helical path 490 (e.g., near the filler rotation axis 430B), and a second distance R2 of the collection insertion channel 466 from the center of the filler body 464 after passing a point near the channel path curve 476. As shown in Figure 4I, the second distance R2 is further from the center of the filler body 464 than the first distance R1. This increment in distance allows for a higher centripetal or centrifugal force to be applied to the channel at the channel end 472 or a point near it than at any other point along the substantially helical path 490. In at least one exemplary embodiment, the end of the blood component collection bladder substantially coincides with the channel end 472, thereby providing the greatest blood separation force at the end of the bladder.

[0101] Figures 4J to 4L show various elevational and cross-sectional views of the filler 460, more specifically, the collection insertion channel 466 and filler insertion chamber 492 located inside the filler body 464. In at least one exemplary embodiment, the collection insertion channel 466 includes a cross-section or shape substantially following a substantially helical path 490 within the filler body 464. The collection insertion channel 466 includes an insertion groove configured to receive a substantially flat or unfilled blood component collection bladder. The blood component collection bladder is inserted into the collection insertion channel 466 and into the filler insertion chamber 492 formed within the filler body 464 along the substantially helical path 490. The filler insertion chamber 492 is defined by one or more side walls 494, 496 that form a cavity following the substantially helical path 490. As shown in Figure 4K, the filler insertion chamber 492 includes an inner chamber wall 494 at a given distance from at least one outer chamber wall 496. The filler insertion chamber 492 may be formed on the filler 460 by 3D printing the filler 460 and / or by some one or more other metal or plastic molding processes (e.g., casting, molding, etc.). In at least one exemplary embodiment, the filler insertion chamber 492 includes one or more insertion guide functional portions 498. These insertion guide functional portions 498 are configured to guide, position, and / or seat a blood component collection bladder inside the filler insertion chamber 492 of the filler 460. The insertion guide functional portion 498 is shown as a chamfered retract functional portion of the filler insertion chamber 492, but may include one or more radii, chamfers, bevels, tapers, draft angles, receptacles, grooves, and / or other molded portions configured to guide and / or direct a portion of the inserted blood component collection bladder.

[0102] Figure 4L shows different states of a fluid collection bladder (e.g., a blood component collection bladder) positioned within the collection insertion channel 466 and filler insertion chamber 492 of the filler 460. As previously mentioned, the blood component collection bladder is inserted into the collection insertion channel 466 in a substantially flat, i.e., unfilled state S1. In the substantially flat state S1, the blood component collection bladder is dimensioned to enter the upper opening of the collection insertion channel 466 and remain in the filler insertion chamber 492 in a pre-filled state. As the filler 460 rotates and begins to separate blood components from the blood supplied by the donor 102, the blood component collection bladder expands from the substantially flat first state S1 to an expanded, i.e., filled state S2. In at least one exemplary embodiment, the blood component collection bladder may expand with blood and / or blood components until the walls of the blood component collection bladder contact the walls 494, 496 of the filler insertion 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 (for example, maximizing the amount of fluid while minimizing the amount of material for the filler 460).

[0103] Example of a blood component collection kit Figures 5A to 5H show a blood component collection set 500 prepared according to at least one exemplary embodiment of the present disclosure. The blood component collection set 500 includes various connections, including, for example, tubes and connectors. For example, as shown, the blood component collection set 500 may include one or more tubes, such as a cassette inlet tube 108A, a loop inlet tube 108B, an anticoagulant tube 110, a loop outlet tube 112, a saline tube 116, and / or a plasma tube 120, as well as one or more connectors, such as a tube connector 106 and / or a saline / plasma tube y-connector 280. The blood component collection set 500 may also include one or more other connectors, such as a first tube fitting 504, a second tube fitting 508, a bag fitting 512, a system fixed loop connector 528, and / or a filler loop connector 532. The various connections can fluidly connect the soft cassette 340 and the blood component collection loop 520.

[0104] One or more tubes, including the cassette inlet tube 108A, the loop inlet tube 108B, the anticoagulant tube 110, the loop outlet tube 112, the saline tube 116, and / or the plasma tube 120 (collectively referred to as "tubes"), each have a central lumen configured to transport fluid through them. The tubes may comprise one or more polymer materials, including, for example, polyvinyl chloride (PVC), plasticized polyvinyl chloride, polyethylene, ethylene vinyl acetate (EVA), rubber, copolymers, and combinations thereof.

[0105] One or more connectors, including the tube connector 106, the saline / plasma tube y-connector 280, the first tube fitting 504, the second tube fitting 508, the bag fitting 512, the system fixed loop connector 528, and / or the filler loop connector 532 (collectively referred to as “connectors”), are configured to fluidly interconnect tubes, and / or to fluidly interconnect tubes and other medical accessories, and / or to fluidly interconnect tubes and needles or spikes. For example, connectors may be inserted into the central lumen of each tube and / or mounted on the outside of each tube, and / or the bag fitting 512 may be configured to be inserted into a receiving bag such as a saline bag 118. In at least one exemplary embodiment, the connectors may include a variety of fittings, including, for example, Luer fittings, twist-connect fittings, and / or other small-bore couplings, to provide a versatile and / or reliable interconnection for establishing a fluid connection.

[0106] As illustrated, the blood component collection loop 520 comprises a flexible loop 524 positioned between a system fixed loop connector 528 and a filler loop connector 532. The fixed loop connector 528 can be attached to the flexible loop 524 and / or the blood component collection bladder 536 by a mechanical lock, which may be formed from a photocurable adhesive, as further described below. The flexible loop 524 may be configured as a hollow flexible tube configured to receive and / or accommodate at least portions of the loop inlet tube 108B and the loop outlet tube 112. In at least one exemplary embodiment, the flexible loop 524 may be made of a highly flexible thermoplastic elastomer for transmitting torsion from the first end to the second distal end and to the second distal end. Such an elastomer can provide the flexibility of rubber while maintaining the strength and torque properties of plastic. Examples of thermoplastic elastomers include, for example, copolyesters, DuPont® Hytre® thermoplastic elastomers, Eastman Neostar® elastomers, Celanese Riteflex® elastomers, TOYOBO PELPRENE® elastomers, and / or elastomers from other manufacturers that provide high flexibility and strength properties.

[0107] In at least one exemplary embodiment, the blood component collection loop 520 may include a blood component collection bladder 536. The blood component collection bladder 536 has a first end or bladder loop end 540A and a second end or bladder free end 540B. The blood component collection bladder 536 includes a first collection flow chamber 544 that extends between the bladder loop end 540A and the bladder free end 540B and is connected to a flexible loop 524 via a filler loop connector 532. For example, in at least one exemplary embodiment, fluid flows between the loop inlet tube 108B and the first collection flow chamber 544 through a flow path defined by the flexible loop 524, a system fixed loop connector 528, and a filler loop connector 532. The bladder free end 540B of the first collection flow chamber 544 includes a flow chamber transition section 548. Fluid flowing from the bladder loop end 540A through the first collection flow chamber 544 to the bladder free end 540B can enter the second collection flow chamber 552 via the flow chamber transition section 548. The second collection flow chamber 552 is connected to the flexible loop 524 via the filler loop connector 532. For example, in at least one exemplary embodiment, fluid flows between the loop outlet tube 112 and the second collection flow chamber 552 through a flow path defined by the flexible loop 524, the system fixed loop connector 528, and the filler loop connector 532.

[0108] In at least one exemplary embodiment, as shown in Figure 5B, the flexible loop 524 may include a first path 509 configured to receive a loop inlet tube 108B and a second path 510 configured to receive a loop outlet tube 112. For example, in at least some exemplary embodiments, at least a portion of the loop inlet tube 108B is held within the first path 509 of the flexible loop 524 and connected to a first collection flow chamber 544 at the bladder loop end 540A via a filler loop connector 532. Alternatively, at least a portion of the loop outlet tube 112 may be held within the second path 510 of the flexible loop 524 and connected to a second collection flow chamber 552 at the bladder loop end 540A via a filler loop connector 532. In this way, the fluid enters the blood component collection bladder 536 via the first collection flow chamber 544, where the fluid is separated (for example, into one or more blood components) and carried along the second collection flow chamber 552 to the loop outlet tube 112, which is held in the second path 510 of the flexible loop 524.

[0109] As shown in the figure, the first collection flow chamber 544 is separated from the second collection flow chamber 552 via a flow chamber separator 542. In at least one exemplary embodiment, the flow chamber separator 542 may be a sealed portion (e.g., a heat-sealed portion) of the blood component collection bladder 536. For example, in at least one exemplary embodiment, the blood component collection bladder 536 may include one or more overlapping and sealed material layers, or may consist of one or more overlapping and sealed material layers. The material layers may include one or more polymer materials. For example, in at least one exemplary embodiment, the material layers may include polyvinyl chloride (PVC), plasticized polyvinyl chloride, polyethylene, ethylene vinyl acetate (EVA), thermoplastics, thermoplastic elastomers, copolymers, and combinations thereof.

[0110] The material layers are molded (e.g., by cutting or other methods) and sealed along one or more edges to form a blood component collection bladder 536. As shown in Figures 5C and 5D, a flow chamber separator 542 can be formed within the blood component collection bladder 536 by sealing one or more material layers to one or more other material layers along one or more pre-selected paths, and / or by sealing one or more first portions of a single material layer to one or more second portions of the single material layer. For example, as shown in Figure 5D, which shows the blood component collection bladder 536 before sealing, the flow chamber separator 542 may be formed as a sealing region of the material by joining the material 536A on the first side of the bladder to the material 536B on the second side of the bladder. Alternatively, the material 536A on the first side of the bladder and the material 536B on the second side of the bladder can be sealed at one or more ends 554A, 554B to form the top and bottom of the blood component collection bladder 536. For comparison, Figure 5C shows the blood component collection bladder 536 after sealing. As shown in Figures 5A and 5B, the seal defining the flow chamber separator 542 does not extend along the entire length of the blood component collection bladder 536, thereby defining a flow chamber transition 548 so that the fluid can pass between the first collection flow chamber 544 and the second collection flow chamber 552.

[0111] At the time of formation, the width (WB) of the bladder may correspond to the width of the first collection flow chamber 544 and / or the second collection flow chamber 552 in the unexpanded state S1 (see, for example, Figure 4L). During operation, as the fluid fills at least a portion of the blood component collection bladder 536, the dimension of the bladder width (WB) may increase from the dimension shown in Figure 5C. For example, in at least one exemplary embodiment, the bladder width (WB) can increase substantially to the size of the filler insertion chamber 492 of the filler 460. In at least one exemplary embodiment, the sealed or welded portion of the blood component collection bladder 536 is supported within the filler 460. For example, as shown in Figures 5G and 5H, the upper part of the filler 460 supports two upper sealing portions 554A, 542, and the bottom part of the filler 460 supports the bottom sealing portion 554B.

[0112] In at least one exemplary embodiment, the blood component collection loop 520 may include one or more positive positioning functional parts (also called key functional parts) 530A, 530B configured to assist in the positive positioning of multiple locations of the blood component collection loop 520 relative to the apheresis system 200, specifically the filler 460 of the centrifuge assembly 400. For example, as shown, the blood component collection loop 520 includes a first connector positioning functional part 530A on or near the system fixed loop connector 528 and a second connector positioning functional part 530B on or near the filler loop connector 532. The positioning functional parts 530A, 530B may be configured as keys, tabs, and / or other protrusions extending from the connectors 528, 532. In at least one exemplary embodiment, the second connector positioning functional portion 530B may include functional portions that interconnect (e.g., mate with) the first positive positioning functional portion 478 and / or the second positive positioning functional portion 480 of the loop connection region 454 of the filler 460.

[0113] Figures 5E–5H are various perspective views of the blood component collection loop 520 in a bent state, and also show the bent blood component collection bladder 536 of the blood component collection loop 520 when inserted into the filler 460 of the centrifuge assembly 400. Various components of the blood component collection loop 520 may be flexible and / or may be formed or shaped by the application of force. In at least one exemplary embodiment, this flexibility may be elastic, such that the components do not permanently deform even if various parts of the blood component collection loop 520 take shape.

[0114] Figure 5E shows the blood component collection loop 520 in a bent state. For example, in Figure 5E, the flexible loop 524 is shown elastically bent along its length, and the blood component collection bladder 536 is shown with multiple bent or curved sections along its length. Although one or more of the various components of the blood component collection loop 520 are in a bent state, the flexible loop 524 nevertheless delivers fluid to the blood component collection bladder 536, for example, via the loop inlet tube 108B, and / or carries fluid away from the blood component collection bladder 536, for example, via the loop outlet tube 112.

[0115] In at least one exemplary embodiment, the blood component collection loop 520 may be pre-formed to fit into the collection insertion channel 466 of the filler 460 of the centrifuge assembly 400, for example, as shown in Figure 5F. This pre-forming may include bending the blood component collection bladder 536 of the blood component collection loop 520 to conform to the substantially helical path 490 of the collection insertion channel 466. Once pre-formed, the functional parts of the blood component collection loop 520 may be aligned with one or more functional parts of the filler 460, as shown in Figure 5G. For example, in at least one exemplary embodiment, the filler loop connector 532 of the blood component collection loop 520 is aligned with the loop connection region 454 of the filler 460 so that a second connector positioning functional part 530B is aligned to engage with a first positive positioning functional part 478. In addition to or instead of the above, the blood component collection bladder 536 may be molded or formed (for example, manually or automatically) to fit the substantially helical path 490 of the collection insertion channel 466 in the filler 460. In at least one exemplary embodiment, this molding or formation may include aligning the bladder free end 540B of the blood component collection bladder 536 with the channel end 472 of the collection insertion channel 466 in the filler 460. As the components are roughly aligned with one another, the blood component collection loop 520 may be moved toward the collection insertion channel 466 and the loop connection region 454, as shown in Figure 5G. In at least one exemplary embodiment, as the filler loop connector 532 moves into the loop connection region 454 of the filler 460, the first positive-movement positioning function portion 478 interconnects with and / or holds the second connector positioning function portion 530B of the filler loop connector 532 of the blood component collection loop 520. This interconnection prevents the filler loop connector 532 from rotating relative to the filler 460. In at least one exemplary embodiment, this interconnection holds the filler loop connector 532 of the blood component collection loop 520 within the loop connection region 454 of the filler 460. Figure 5H shows the blood component collection loop 520 mounted on the filler 460.The system fixed loop connector 528 and the filler loop connector 532 work together to transmit the torque applied to the flexible loop 524 to the blood component collection bladder 536 and the filler 460.

[0116] In at least one exemplary embodiment, the fluid (blood and / or blood components, etc.) in the blood component collection bladder 536 housed in the filler insertion chamber 492 of the filler 460 can move 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 movement direction 546) to the second collection flow chamber 552. In this example, the blood components (e.g., plasma, etc.) return along the second collection flow chamber 552 toward the center of the filler body 464 via a substantially spiral path 490 and through the loop outlet tube 112 (e.g., toward the plasma collection bottle 122).

[0117] Example of a centrifugal separator assembly in a loop configuration. Figures 6A to 6C are schematic cross-sectional views of the centrifuge assembly 400 in various loop-mounted states according to at least one exemplary embodiment of the present disclosure. The centrifuge assembly 400 shown in Figures 6A to 6C corresponds to the centrifuge assembly 400 described above, particularly in relation to Figures 4D to 4F. Specifically, Figure 6A shows a schematic cross-sectional view of a first loop-mounted state, Figure 6B shows a schematic cross-sectional view of a second loop-mounted state, and Figure 6C shows a schematic cross-sectional view of the centrifuge assembly 400 in a second loop-mounted state.

[0118] In Figure 6A, the centrifuge assembly 400 is shown in the open loop mounting position, in which the upper housing 404B is rotated 180 degrees from the closed position, i.e., the 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 with 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 section 402 via the system fixed loop connector 528. In this first loop mounting state, the flexible loop 524 is fixed to the fixed loop connection section 402 so as not to rotate, but rotates together with the filler 460 in the loop connection region 454.

[0119] In Figure 6B, the centrifuge assembly 400 is shown in a partially closed position, in which the upper housing 404B is moving from the open position to the closed position, i.e., the operating position. As the upper housing 404B rotates, the flexible loop 524 can move to a stationary position relative to the centrifuge assembly 400. The flexible loop 524 is fixed in the rotational direction at the fixed loop connection 402, but the filler 460 can rotate freely around the filler rotation axis 430B (limited, for example, only by the flexible loop 524 which is fixed in the rotational direction).

[0120] In Figure 6C, the centrifuge assembly 400 is shown in the closed position, i.e., the operating position, in which the upper housing 404B can be locked to the lower housing 404A (so that the lower housing 404A and the upper housing 404B can rotate together around the centrifuge rotation axis 430). In this position, the flexible loop 524 extends from the loop connection area 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 can move freely within the loop access clearance 436, with or without contact with one or more portions of the centrifuge split housing 404. In this position, as the centrifuge assembly 400 rotates around the centrifuge rotation axis 430, the flexible loop 524, which is fixed in the rotational direction at the fixed loop connection 402, can twist along the length of the flexible loop 524, thereby causing the filler 460 to rotate within the centrifuge assembly 400 (for example, along the centrifuge rotation 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 one full turn, the flexible loop 524, which is fixed in the rotational direction (for example, fixed at the fixed loop connection 402), twists in the loop connection region 454 (for example, attempting to unwind from the twist caused by the rotation of the centrifuge assembly 400), thereby causing the filler 460 to rotate in the same rotational direction as the centrifuge assembly 400, but approximately two full turns. This rotation of the filler 460 by the twist along the length of the flexible loop 524 does not require engagement between the centrifuge assembly 400 and the filler 460.

[0121] Example of a centrifugal separator assembly in a loop configuration. Figures 7A and 7B show schematic plan views of a centrifuge assembly 400 that automatically mounts the loop to the centrifugation operating position (e.g., blood separation). The centrifuge assembly 400 shown in Figures 7A and 7B may correspond to the centrifuge assembly 400 described and / or explained above in relation to Figures 4A to 4F and Figures 6A to 6C. Once the blood component collection loop 520 is mounted within the centrifuge assembly 400 as shown in Figure 6C, the flexible loop 524 is automatically mounted to the loop engagement position 520B as shown in Figures 7A and 7B.

[0122] In at least one exemplary embodiment, when the upper housing 404B is locked into the lower housing 404A, the flexible loop 524 extends from the loop connection area 454 of the filler 460 to the fixed loop connection 402 of the apheresis system 200. The flexible loop 524 may be rotatably fixed to the fixed loop connection 402 by the system fixed loop connector 528, but the flexible loop 524 passing through the loop access clearance 436 of the centrifuge split housing 404 may not be initially held, or at least partially captured, by the loop rotation positioning guide 424 and / or other functional parts 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 the uncaptured loop state 700A. In other words, the flexible loop 524 may be oriented at some angle (α) with respect to the loop rotation positioning guide 424, the loop positioning stopper plate 704, and / or one or more loop torsion support bearings 708, or a set of bearings. In at least one exemplary embodiment, the loop torsion support bearing 708 may correspond to the bearing 417 described in conjunction with Figures 4B-4C. The loop storage area, or channel, may be formed by one or more loop torsion support bearings 708 arranged along the length of the loop positioning stopper plate 704 and / or the upper housing 404B. In at least one exemplary embodiment, this arrangement may be designed to allow for ease of access and / or mounting in the loop mounting described in conjunction with Figures 6A-6C.

[0123] As the centrifuge assembly 400 is rotated in the loop-filler rotation direction 712 around the centrifuge rotation axis 430, the flexible loop 524 can move from an uncaptured loop state 700A to a captured loop state 700B as shown in Figure 7B. This rotation may be caused by an operator rotating the centrifuge assembly 400 and / or the filler 460 in the loop-filler rotation direction 712 and / or by a rotor motor assembly 414 rotating the centrifuge assembly 400 around the centrifuge rotation axis 430. In at least one exemplary embodiment, as the flexible loop 524 rotates in the loop-filler rotation direction 712, the outer portion of the flexible loop 524 comes into contact with the loop positioning stopper plate 704 or another rotation stopper surface of the loop rotation positioning guide 424.

[0124] With the flexible loop 524 held or at least partially housed within the loop rotation positioning guide 424, a portion of the flexible loop 524 can move within one or more of the loop torsion support bearings 708. As previously stated, the flexible loop 524 may be rotationally fixed to the fixed loop connection 402 via the first connector positioning functional portion 530A of the system fixed loop connector 528 associated with the blood component collection loop 520. This rotationally fixed connection prevents the flexible loop 524 from rotating relative to the apheresis system 200 at the fixed loop connection 402. The other end of the flexible loop 524 may be interconnected at the loop connection region 454 of the filler 460 so that this end can move together with the filler 460 and / or 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 to avoid unraveling or entanglement causes the filler 460 and the end of the flexible loop 524 attached to the filler to rotate.

[0125] In any case, once the fluid separation method described herein is completed, the rotation of the centrifuge assembly 400 is stopped, and the centrifuge split 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 captured loop state 700B shown in Figure 7B to the uncaptured loop state 700A shown in Figure 7A by rotating the centrifuge assembly 400 and / or filler 460 in the opposite direction to the loop filler rotation direction 712.

[0126] Example of a functional diagram for an apheresis system A functional diagram of the apheresis system 200 is shown in Figure 8 according to at least one exemplary embodiment of the present disclosure. The description herein illustrates 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, and therefore shows the components in the functional diagram that have already been described in Figures 1 to 7B.

[0127] System 200 may include an anticoagulant (AC) pump 216. The AC pump 216 delivers fluid from the AC bag 114 into the AC tube 110. The AC pump 216, AC tube 110, and / or AC bag 114 may be those described above. The AC tube 110 may also include an AC air detection sensor (ADS) 804 to detect air or fluid within the AC tube 110. The AC ADS 804 may be of the same type and / or function as the sensors 284 and / or 312 already described. The AC tube 110 is fluidically associated with the donor supply tube 104 and the cassette inlet tube 108A by intersecting them at a tube connector 106. The tube connector 106 may be any type of connection between tubes 110, 104, and / or tube 108A, as already described.

[0128] The donor supply tube 104 extends from the donor 102, in which case the donor 102 may be punctured with a lumen needle or other device, thereby allowing whole blood to flow from the donor 102 into the apheresis system 200 and blood components to flow back into the donor 102. Tube 108A extends to the soft cassette 340. Furthermore, a donor air detection sensor 312 can be placed on or inside tube 108A to detect the presence of fluid and / or air in tube 108A.

[0129] As already described, the soft cassette 340 may include a "Y" connector or section or branch that can function as a "Y" connector or section or branch, and / or may be substantially adjacent to the "Y" connector or section or branch, which separates tube 108A into a first bypass branch 358A and a first tube section 368A (the "Y" section is indicated by reference letter 360A). The two tube sections 358, 368 are reconnected at a second cassette port 360B that may also include a second "Y" connector or section that can function as a second "Y" connector or section, and / or may be substantially adjacent to the second "Y" connector or section (the second "Y" section is indicated by reference letter 360B). Tube 358 is divided into two by a fluid sensor 316, which separates tube 358 into a first bypass branch 358A and a second bypass branch 358B. Similarly, tube 368 is divided into two by a drip chamber 354, which separates tube 368 into a first tube section 368A and a second tube section 368B.

[0130] The first tube section 368A may include a first fluid control valve 320A. Similarly, the second tube section 368B may include a second fluid control valve 320B. Similarly, the first bypass branch 358A may include a draw-in fluid control valve 320C. Thus, depending on the configuration of the system 200 and the operation of the system 200, various sections of the tubes 368A, 358A, 358B, and 368B can be isolated by valves 320A, 320B, and / or valve 320C.

[0131] The drip chamber 354 may be located between the first tubing section 368A and the second tubing section 368B. The drip chamber 354 can collect a predetermined amount of whole blood and / or high hematocrit blood (blood with a high percentage of red blood cells) depending on the operation of the system 200, as will be described later. The fluid sensor 316 may be located between the first bypass branch 358A and the second bypass branch 358B, as already described.

[0132] The inlet tube 108B can be connected to a second cassette port 360B and to a soft cassette 340 which can be connected to a flexible loop 524. The inlet tube 108B may also include a sensor 808 positioned on or inside the tube 108B and positioned together with the tube 108B before being connected to the system fixed loop connector 528 of the flexible loop 524. The pressure sensor (CPS) 808 may, but is not limited to, detect the pressure, presence or absence of fluid or air in the tube 108B, and / or, optionally, one or more other characteristics of the fluid. Furthermore, a draw-in pump 208 can pump fluid through the tube 108B away from or into the soft cassette 340.

[0133] Two or more different tubes can be connected to the flexible loop 524 via the system fixed loop connector 528, and two or more different tubes can supply fluid to or receive fluid from the blood component collection bladder 536. The outlet tube 112 exits the flexible loop 524 through the system fixed loop connector 528. This outlet tube 112 includes other line sensors 812 placed on or inside the outlet tube to detect fluid, air, intracellular concentration, color, and / or color changes in the fluid coming from the flexible loop 524. The line sensors 812 may be the same as or similar in type and / or function to the sensors 804, 312, 320, 808 and / or sensor 284 already described. A second CPS sensor 816 or fluid sensor may be placed inside or on the line 112. Sensor 816 may detect, but is not limited to, the presence or absence of fluid in tube 112, its pressure, and / or one or more other characteristics of the fluid in tube 112. Similarly, sensor 816 may be the same as or similar in type and / or function to sensors 804, 312, 320, 808, 812, and / or sensor 284 already described.

[0134] The outlet tube 112 may then flow into the plasma air detection sensor 284 before the saline / plasma tube Y-connector 280 separates the outlet tube 112 into the saline tube 116 and the plasma tube 120. A return pump 212 may interact with the outlet tube 112, which may allow fluid or air to flow through the outlet tube 112 from the flexible loop 524 or from the saline bag 118 and / or plasma collection bottle 122.

[0135] The saline bag 118 and its associated tubing may be configured as already described, and saline can be supplied to the original 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. Furthermore, a plasma collection bottle 122 can receive plasma from the flexible loop 524 when it is processed or separated from whole blood. The plasma collection bottle 122 can be selectively isolated from the system by a plasma flow control valve 286.

[0136] Electrical and control systems Embodiments of the electrical and control system 900 that control the functions of the apheresis system 200 may be as shown in Figure 9 according to embodiments of the present disclosure. The control system 900 may include one or more nodes, which may include various hardware, firmware, and / or software configured to control and / or communicate with the mechanical, electromechanical, and electrical components of the apheresis system 200.

[0137] Each node may function to control a different part of the apheresis system 200. For example, the control system 900 may include a cassette node 904 (which is a soft cassette assembly system) and a centrifuge node 908 (which is a centrifuge system) that can control or communicate with components of the blood component collection set 500 (and associated hardware or mechanical components that interface with the soft cassette assembly 300) and the centrifuge assembly 400 (and associated hardware or mechanical components associated with the centrifuge assembly). The cassette node 904 and the centrifuge node 908 may communicate wirelessly or via some other electrical or data connection. In some configurations, the cassette node 904 and the centrifuge node 908 may be separate nodes that are two parts of a single node 902. Thus, each of the cassette node 904 and the centrifuge node 908 may have the same physical hardware that operates to control different functions. In at least one exemplary embodiment, a single node 902 may include physical hardware for both the cassette node 904 and the centrifuge node 908, or the cassette node 904 may include physical hardware separate from the physical hardware of the centrifuge node 908. An example of the cassette node 904 can be described in relation to Figure 10, and the centrifuge node 908 can be described in relation to Figure 11.

[0138] Each of the cassette node 904 and the centrifuge node 908 may communicate with one or more sensors 916, 920, and / or sensors 924. There may be more or fewer sensors than those shown in Figure 9, as indicated by the abbreviation 928. Each of the cassette node 904 and the centrifuge node 908 may communicate directly with each of the sensors 916-924, or it may communicate with several sensors 916-924 via bus 912. Bus 912 may communicate by any type of communication protocol, such as a Universal Serial Bus (USB), a Universal Asynchronous Transceiver (UART), or any other type of bus system or parallel communication connection. Thus, bus 912 is shown as an optional but possible communication platform for communicating with various sensors 916-924. Sensors 916-924 may be any type of sensor capable of communicating information such as light, fluid, presence of air, color, pressure, etc., as described herein. Some examples of sensors 916-924 include the air detection sensor 312, the fluid sensor 316, the AC ADS 804, the pressure sensor 808, the line sensor 812, the second CPS sensor 816, and / or the air detection sensor 284. The functions of these sensors 912-924 will be described later.

[0139] Cassette node 904 and centrifuge node 908 may also communicate with one or more pump drives, pump motors 936, 940, 944 (simply referred to as pumps), etc. There may be more or fewer pumps than those shown in Figure 9, as indicated by the abbreviation 948. Cassette node 904 and centrifuge node 908 can communicate with pumps 936-944 directly via 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, or be part of, at least one of the draw pump 208, return pump 212, and / or AC pump 216, as described above. The functions of pumps 936-944 are described herein.

[0140] One embodiment of the cassette node 904 may be as shown in Figure 10 according to an embodiment of the present disclosure. The cassette node 904 may include a controller 1004, a memory 1008, a valve controller 1020, and / or one or more of the following: a CAN bus 1016, a UART 1012, or a communication interface for other types of buses. The cassette node 904 may include other hardware, firmware, and / or software, which are not shown for clarity.

[0141] The controller 1004 (also referred to herein as the processor) may be any type of microcontroller, microprocessor, field-programmable gate array (FPGA), application-specific integrated circuit (ASIC), etc. An example of the controller 1004 may be the NK10DN512VOK10 microcontroller, manufactured and sold by N9P USA, Incorporated, which is a microcontroller unit with a 32-bit architecture. Other types of controllers may also be envisioned. The controller 1004 can control or instruct other types of devices, such as the first fluid control valve 320A, the second fluid control valve 320B, the intake fluid control valve 320C, the plasma flow control valve 286, the saline flow control valve 288, and pumps 936-944. Furthermore, the controller 1004 can communicate with various sensors 916-924 or other devices to receive or send information regarding the function of the apheresis system 200.

[0142] Other examples of processors or microcontrollers 1004 as described herein include 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, and Intel® Core® i5-3570K 22nm The computer may include, but is not limited to, at least one of the following: IvyBridge, AMD® FX® processor family, AMD® FX-4300, FX-6300, and FX-8350 32nm Vishera, AMD® Kaveri processor, ARM® Cortex®-M processor, ARM® Cortex-A and ARM926EJ-S® processor, or other industrial equivalent processors, and may perform computer functions using any known or future-developed standard instruction sets, libraries, and / or architectures.

[0143] Memory 1008 may be random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), portable compact disk read-only memory (CD-ROM), optical memory, magnetic memory, any suitable combination thereof, or any other type of memory including other types of memory devices or memory units that store and provide instructions for programming and controlling the controller 1004. Memory 1008 may also provide all types of software or firmware for programming the functions of the controller 1004, as described later.

[0144] Controller 1004 can communicate with one or more valve controllers 1020. Each valve, such as the first fluid control valve 320A, the second fluid control valve 320B, the suction fluid control valve 320C, the plasma flow control valve 286, and the saline flow control valve 288 as described herein, may be controlled by a valve controller 1020 and associated with a component of the system 200, as described herein. A valve controller 1020 can supply 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 suction fluid control valve 320C.

[0145] The controller 1004 can also be connected to buses 912, 932 (e.g., UART bus, CAN bus) or other buses via transceivers 1012, 1016 located outside or integrated with 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 can communicate with one or more of the pump controllers 936-944 or other devices. The UART transceiver 1012 and bus and the CAN bus transceiver 1016 and bus are well known in the art and do not need to be further described herein.

[0146] Figure 11 shows one embodiment of a centrifuge node 908 according to an embodiment of the present disclosure. The centrifuge node 908 may include the same or similar types of components as the cassette node 904. For example, the centrifuge node 908 may include a controller 1104, a UART transceiver 1112, etc. Similar to the controller 1004, the controller 1104 may be any type of processor or microcontroller, for example, the NK10DN512VOK10 microcontroller unit with a 32-bit architecture provided by N9P USA, Incorporated as previously mentioned, or other controllers, processors, etc. (for example, the devices previously mentioned).

[0147] The controller 1104 can communicate with sensors 916-924 via UART transceiver 1112 or directly via another bus or system. The controller 1104 can also communicate with brake controller 1124, which can brake, decelerate, and stop the centrifuge 400. Similarly, the controller 1104 can communicate with motor transceiver 1116, which communicates with a motor power system or motor controller that functions to spin up or rotate the centrifuge 400 or to control the speed setting or other functions of the centrifuge 400.

[0148] In some configurations, the controller 1104 can also communicate with a cuff controller 1120, which can change or set the pressure of a pressure cuff on the donor arm during the apheresis process. Furthermore, as already described, the controller 1104 can communicate with and / or control the strobe light 1114, which can be any light that flashes periodically in sync with the motor's rotation speed, so that the operator of the apheresis system 200 can observe the operation of the filler 460. Thus, the controller 1104 can communicate with the strobe light 1114 to change the flashing frequency, intensity, etc.

[0149] As should be understood, the cassette node 904 and the centrifuge node 908 include other components as described in the specification entitled “Method and System for High-Throughput Blood Component Collection,” filed on 3 August 2021, with agent reference number 18955-000019-US and granted U.S. Patent Application No. 17 / 392804. The entirety of the aforementioned U.S. Patent Application is expressly incorporated herein by this disclosure.

[0150] Examples of code scanning and data control methods In at least one exemplary embodiment, a data entry process, as illustrated in Figure 12A, is used to initialize the apheresis system 200 for each new donor 102. The data entry process ensures that a target amount or volume of plasma is obtained based on donor weight or other donor information. Information such as bottle identification is also entered through the data entry process so that the apheresis system can record in memory which bottle was used for which donor.

[0151] In at least one exemplary embodiment, the process shown in Figure 12A begins at 1200, where the apheresis system 200 is powered on and awaits a new donor. The apheresis system 200 may include an integrated identification reader (e.g., an RFID reader, barcode reader, etc.) 1221, as shown in Figure 12B. The identification reader 1221 is configured to read a code (e.g., an RFID tag, barcode, etc.) associated with a particular donor 102 and to control the operation of the apheresis system 200 based on the information read by the identification reader. This information may include, but is not limited to, individual donor data (e.g., body mass index (BMI), first donor, weight, height, etc.). This information may be used to provide faster and higher quality donor blood donation. The code may also be used to label other devices used during the blood donation process, such as a label 1227 on a bottle 1224 used for plasma collection, as shown in Figure 12C.

[0152] In step 1203, the reader 1221 of the apheresis system 200 is used to scan a barcode, QR code (registered trademark), or other type of image and receive data associated with the donor. In at least one exemplary embodiment, the reader 1221 may be configured to read input from RFID. For example, a donor may use an ID card or other type of object that includes one or more of the following: a barcode, QR code, RFID, etc. By scanning the ID card or other type of object, the apheresis system 200 can receive data about the donor.

[0153] Barcodes (e.g., 1D, 2D, etc.) are read by an integrated barcode scanner located on the front of the apheresis system. For example, when initiating an apheresis procedure, the user sequentially scans the donor ID (e.g., from a PDA, phone, tablet, etc.), the blood component collection set (e.g., the separation set), and / or the plasma collection bottle. No further input from the user via a user interface is required. The system can receive the information and automatically verify the data entry without human input. As can be seen, this automated sequential data acquisition increases operating speed compared to conventional non-sequential input.

[0154] Data received from a donor may include biological information such as age, weight, height, donor history, or other information that may be relevant to the donation process. The data received from the donor is used to determine whether the donor is eligible for the blood donation procedure and to determine specific settings required for the procedure, such as the expected total plasma volume or other information. For example, the donor's height and weight can be used to determine the donor's body mass. Then, the donor's body mass can be used to determine the target volume or amount of plasma to be collected.

[0155] In at least one exemplary embodiment, the information may be portable between blood donation facilities (blood donation sites), apheresis systems 200, locations, etc. The information may be stored in the form of a nomogram, for example, as a two-dimensional barcode. In this way, donors can have a single form of identification across blood donation sites, and each blood donation site can collect information about the donor, such as the time since the last visit.

[0156] The information stored in the nomogram and readable by the integrated identification reader is limited to information that the apheresis system 200 is permitted to collect (e.g., by privacy laws, health laws, etc.). In at least one exemplary embodiment, other private information may be stored in the two-dimensional barcode, but may be encrypted or locked for readability by the integrated identification reader of the apheresis system 200.

[0157] The apheresis system 200 scans or reads a barcode and then determines what action to perform. For example, the barcode may contain information about the weight and height of donor 102. This can be used to determine the amount or volume of plasma that donor 102 can provide or donate. As can be understood, donor 102 with a first weight can provide a first amount of plasma, while donor 102 with a second, heavier weight can provide a second amount of plasma, which is greater than the first amount. Furthermore, the body mass of donor 102 can also be used to determine the amount or volume of plasma that donor 102 can provide or donate. Once the apheresis system 200 has read the barcode, it can adjust its settings based on the information and stop operating when the required amount of plasma, etc., has been collected.

[0158] The apheresis system 200 is also capable of writing information that can be read by other apheresis systems at the same or other blood donation sites. For example, donor data may be stored in a network location. The apheresis system 200 is also capable of transmitting data such as blood donation results, the donor's current weight, the date and / or time of donation, or other information.

[0159] In at least one exemplary embodiment, the apheresis system 200 may comprise one or more computer systems. For example, as will be described in more detail below with respect to Figure 16D, the apheresis system 200 may include one or more computer systems 1627 comprising a processor 1630, memory 1633, input / output devices 1636, one or more pump control systems 1639, one or more sensors 1642, and / or other elements that can be understood.

[0160] In at least one exemplary embodiment, as will be described in more detail below with respect to Figure 16B, the apheresis system 200 can communicate with the server 1621 via a network 1618 such as the Internet. In at least one exemplary embodiment, the apheresis system 200 may communicate with a local computer system, such as a computer located at a blood donation site, which is configured to communicate with the server.

[0161] In at least one exemplary embodiment, after receiving data associated with a donor, the apheresis system 200 may confirm receipt of the data via a feedback system such as a graphical user interface (GUI) 1230, as shown in Figures 12B and 12D. In this way, a nurse, physician, or other user of the apheresis system 200 can quickly confirm whether the donor information has been properly entered into the apheresis system 200. In at least one exemplary embodiment, the feedback system may further, or alternatively, include a speaker configured to provide voice feedback.

[0162] In 1206, the apheresis system 200 determines the identity of the donor based on data associated with the donor. For example, the apheresis system 200 is configured to use data received via the scanner 1221 to identify whether the donor is associated with donor ID information in the database or whether the donor is a new donor. In at least one exemplary embodiment, the scanner 1221 may access donor information from a server or other computer system locally or via a network connection.

[0163] Donor ID information accessed through the database may include information such as age, body mass, weight, height, and / or target volume, i.e., the expected amount of plasma or other donor fluid to be received from the donor.

[0164] In 1209, the apheresis system 200 receives data associated with a blood component collection set. The blood component collection set may comprise a soft cassette assembly, such as a soft cassette assembly 300 used during the blood donation process. Data associated with a blood component collection set may be received by the apheresis system 200 via a barcode, QR code, RFID chip, or other type of scannable object placed on the blood component collection set. For example, each blood component collection set may have a label or sticker attached to it containing an individual barcode, QR code, RFID chip, or other type of scannable object. By scanning the label or sticker on the blood component collection set, the apheresis system 200 is able to record in memory which blood component collection set is being used for the current blood donation process. In this way, the apheresis system 200 is able to associate a donor with a blood component collection set. Any data received during the scanning process may be recorded in memory and shared with a server or other type of computing system.

[0165] The data associated with a blood component collection set may include the manufacturing date, the manufacturer's identity, and other information that may be useful for data processing purposes after the blood donation is completed. In at least one exemplary embodiment, the data associated with a blood component collection set received through scanning is used to determine the type of blood component collection set. The type of blood component collection set may be used by the apheresis system to adjust one or more settings, such as flow rate or other information, during the blood donation process.

[0166] In at least one exemplary embodiment, after scanning a blood component collection set, the user of the apheresis system 200 can receive confirmation of the reception of information from the blood component collection set. For example, a graphical user interface 1230, as shown in Figure 12D, displays information regarding whether data has been received from the blood component collection set. Such a graphical user interface 1230 may be used by the operator of the apheresis system in the process of initializing the apheresis system for a new donor. In at least one exemplary embodiment, instead of, or in addition to, displaying through a graphical user interface, the apheresis system may indicate that data has been received by playing sound through one or more speakers or by displaying lights of various colors.

[0167] In 1212, the method uses the apheresis system 200 to receive data associated with the plasma collection bottle. For example, a plasma collection bottle is required to initialize the apheresis system 200 for a new donor. After collection, the plasma collection bottle is filled with the collected plasma. For data tracking purposes, the plasma collection bottle needs to be associated with a donor. For example, information linking the donor to the plasma collection bottle is stored in memory. For this reason, it is necessary that the individual identification of the plasma collection bottle is recorded. Thus, a user of the apheresis system 200 can use the apheresis system 200 to scan labels, stickers, or other items printed on or over the plasma collection bottle. For example, a sticker or label 1227 may be affixed to the plasma collection bottle 1224 as shown in Figure 12C. In some exemplary embodiments, the sticker or label 1227 includes a QR code.

[0168] As with other steps, once data is received from the plasma collection bottle, the apheresis system 200 may confirm the receipt of the data via a graphical user interface, speaker, white, or other feedback system.

[0169] In step 1215, the apheresis system performs the plasma collection process based on the information received in the above step. For example, the apheresis system 200 performs the plasma collection process using information about the donor's identity. Data received from the plasma collection bottle and / or blood components may also be used during the plasma collection process.

[0170] For example, the flow rate during the plasma collection process is controlled based on one or more of the donor's body mass and weight, which are determined based on received data associated with the donor. The volume of plasma collected is also controlled based on one or more of the donor's body mass and weight, which are determined based on received data associated with the donor.

[0171] At step 1218, the process ends. At that point, the blood donation process may continue with the extraction of fluid from the donor that has been completed. The data received through the steps described above may be recorded in memory and / or shared with one or more computer systems. For example, a database entry may be created for that particular blood donation containing information such as the amount or volume of plasma extracted from the donor, the donor's current weight, the time and / or date of the donation, and / or other information.

[0172] At least one exemplary embodiment of the present disclosure includes a method comprising: using an apheresis system to receive data associated with a donor; determining the donor's identity based on the data associated with the donor; using an apheresis system to receive data associated with a blood component collection set; using an apheresis system to receive data associated with a plasma collection bottle; and using an apheresis system to perform a plasma collection process based on the donor's identity, the data associated with the blood component collection set, and the data associated with the plasma collection bottle.

[0173] In an embodiment of the above, receiving data associated with a donor includes scanning an image with a scanner. In an embodiment of the above, the scanner is located in the apheresis system. In an embodiment of the above, the image is one of a one-dimensional barcode and a two-dimensional barcode. In an embodiment of the above, the image is displayed on a user device. In an embodiment of the above, receiving data associated with a donor includes scanning an RFID. An embodiment of the above includes confirming the receipt of the donor-related data via a feedback system after receiving the donor-related data. In an embodiment of the above, the feedback system comprises one or more of a speaker and a graphical user interface. An embodiment of the above includes determining that the donor is a new donor based on the data associated with the donor. An embodiment of the above includes determining one or more of the donor's body mass and weight based on the data associated with the donor. In an embodiment of the above, receiving data associated with a blood component collection set includes scanning one or more of an image and an RFID attached to the blood component collection set using a scanner. One aspect of the above embodiment includes, after receiving data associated with a blood component collection set, confirming the receipt of the data associated with the blood component collection set via a feedback system. In one aspect of the above embodiment, the feedback system comprises one or more of a speaker and a graphical user interface. In one aspect of the above embodiment, receiving data associated with a plasma collection bottle includes scanning one or more of an image and an RFID attached to the plasma collection bottle using a scanner. One aspect of the above embodiment includes, after receiving data associated with a plasma collection bottle, confirming the receipt of the data associated with the plasma collection bottle via a feedback system. In one aspect of the above embodiment, the feedback system comprises one or more of a speaker and a graphical user interface.In the embodiment described above, the flow rate during the plasma collection process is controlled based on one or more of the donor's body mass and weight, which are determined based on received data associated with the donor.

[0174] Examples of calibration, maintenance, and inspection of apheresis systems The apheresis system 200 comprises one or more devices, systems, and / or functional parts configured to allow the apheresis system 200 to be calibrated in-situ. For example, the apheresis system 200 comprises one or more devices, systems, and / or functional parts configured to allow the apheresis system 200 to be calibrated in-situ. In other words, the apheresis system 200 is calibrated after manufacturing and after installation at the donor processing site. Conventional systems do not provide a method for in-situ calibration.

[0175] In at least one embodiment, the apheresis system 200 is self-calibrating. The apheresis system 200 includes, for example, a pump and syringe that utilize pressure supplied from a compressor integrated with the apheresis system 200 to set a calibration pressure. In other embodiments, the compressor does not have to be integrated with the apheresis system 200 and may be a separate component. The apheresis system 200 may also include a test port configured to generate a known pressure or calibration pressure using, for example, a pump and compressor. In at least one exemplary embodiment, the test port is located on the back of the apheresis system 200 adjacent to other ports, such as a pressure cuff connector, which can change or set the pressure of a pressure cuff on the donor's arm during the apheresis process, as described above with respect to Figure 11. The tubing of the blood component collection loop 520, the calibration tubing set, etc., may be attached to the test port for testing and / or calibration, or otherwise interconnected. When interconnected with a test port, the compressor generates a known calibration pressure, and the pressure sensors in the apheresis system 200 can be calibrated based on the pressure detected by the pressure sensors. For example, the known calibration pressure is compared with the detected pressure, and the difference is used to calibrate the pressure sensors. The pressure sensors may be located, for example, at the test port or at any other location within the apheresis system 200.

[0176] Calibration may also include a step of checking and / or calibrating holders such as the holder 1300 shown in Figure 13A and / or the bottle tray load cell assembly shown in Figures 15A-15C, using a calibration object having a known weight (e.g., NIST weight). This is described in more detail below. In at least one exemplary embodiment, the holder 1300 may be configured to receive a plasma collection bottle 122. The holder 1300 may be located on the upper cover 210 of the housing 204, and may be similar to the plasma collection cradle 232C as shown in Figure 14A. The holder 1300 may include a weight sensor configured to detect the weight of an object placed on the holder 1300. Thus, during calibration, a calibration object is placed on the holder 1300 and the weight sensor can detect the weight of the calibration object. The difference between the known weight of the calibration object and the detected weight detected by the weight sensor indicates that the weight sensor requires calibration (which may be automatically triggered by the difference) or inspection. In at least one exemplary embodiment, if the difference is greater than a predetermined threshold, the apheresis system 200 automatically initiates calibration of the weight sensor. In other embodiments, if the difference is greater than a predetermined threshold, a notification may be issued to warn the user to calibrate the weight sensor.

[0177] Calibration tests and / or calibrations may be performed when one or more components are replaced or swapped in the apheresis system 200. For example, a calibration test may be initiated when one or more pumps (e.g., pumps 208, 212, 216) are replaced or swapped. If one or more components of the apheresis system 200 fail the calibration test, calibration (regardless of pressure, sensor, weight, etc.) may be performed automatically. If the calibration of one or more components fails, the apheresis system 200 is locked and cannot be used until each component passes its respective calibration test.

[0178] The calibration test and method 1302 for performing the calibration, as shown in the flowchart of Figure 13B, begin at 1304. At the start of method 1302, one or more calibration tests are performed. The calibration tests may be automatically started when one or more components of an apheresis system, such as the apheresis system 200 (e.g., one or more sleds, sensors, pumps, etc.) are replaced or swapped. In other exemplary embodiments, the calibration tests may be started by user input. In yet another exemplary embodiment, the calibration tests may be performed before use of the apheresis system 200.

[0179] In step 1306, one or more components of the system (e.g., calibration tube, sensor, pump, etc.) are automatically calibrated. Calibration may be initiated, for example, by the failure of at least one of the one or more tests performed in step 1304. In other exemplary embodiments, calibration may be initiated by user input. Calibration may be performed using one or more calibration tools, for example, a pump, test port, calibration object, etc. When performing calibration, the user may be prompted to connect one or more calibration tools or components to perform calibration via a user interface such as a graphical user interface (GUI).

[0180] It will be understood that steps 1304 and 1306 may be repeated (separately or together). For example, a component may fail the calibration test in step 1304, be automatically calibrated in step 1306, and then be tested again in step 1304 to test whether it has been properly calibrated.

[0181] The apheresis system 200 may also include one or more protocols for inspecting the device. These protocols may include calibration (as described above), automated tests (e.g., limit and full-range tests), fluid runs (with actual parameters), etc. In at least one exemplary embodiment, a saline check is performed. In such an embodiment, the apheresis system 200 may include a weight sensor configured to detect the weight of the plasma collection bottle 122. Saline is transferred from the saline bag 118 to the plasma collection bottle 122, and any change in the weight of the plasma collection bottle 122 is detected by the weight sensor. Such a change in weight indicates that the saline is flowing properly from the saline bag 118 through the saline tube 116 to the plasma collection bottle 122. In at least one exemplary embodiment, for leaks, a disposable item test is performed to check for leaks in the blood component collection set 500. In such an embodiment, the apheresis system 200 includes a pump configured to create a vacuum within the blood component collection set 500. The apheresis system 200 may also include sensors for detecting such leaks in the blood component collection set 500. In one exemplary embodiment, a centrifuge test is performed to test the centrifuge assembly 400. In such an embodiment, the rotor motor and motor assembly 414 may be started to verify proper rotation of the centrifuge assembly 400.

[0182] Example of a moving loop holder Figures 14A to 14F show a mobile loop holder 1400 as included in the apheresis system 200. As shown, the mobile loop holder 1400 may be located at least partially within the centrifuge chamber 1402 of the apheresis system 200. The centrifuge chamber 1402 is defined as an internal space of the apheresis system 200 that houses the centrifuge assembly 400, and is located, for example, behind the access panel 224. As shown in Figure 14B, the mobile loop holder 1400 is located above the centrifuge assembly 400 (for example, spaced apart from the centrifuge assembly 400 in the positive z-axis direction). The mobile loop holder 1400 may correspond to the fixed loop connector 402 or a portion of the fixed loop connector 402 described above.

[0183] The movable loop holder 1400 includes a loop holder body (also called the loop holder) 1408 having a loop connection space (also called the loop connection portion) 1412. A portion of the blood component collection set 500 is held by the loop connection space 1412. For example, as illustrated in Figure 14C, the loop connection space 1412 may be configured to receive or capture a portion of the flexible loop 524, a system fixed loop connector 528, or a combination thereof. In at least one exemplary embodiment, a connector lock wheel 1424 and a flange 1428 function to (securely) lock the system fixed loop connector 528 within the loop connection space 1412. For example, as shown, the system fixed loop connector 528 and / or the flexible loop 524 are positioned between the upper connector lock wheel 1424 and the flange 1428, and the upper connector lock wheel 1424 moves relative to the flange 1428 to apply holding pressure to the system fixed loop connector 528 and / or the flexible loop 524. In at least one exemplary embodiment, the movable loop holder 1400 allows the distance of the flexible loop 524 used in the blood component collection set 500 to be shorter than the distance required in the absence of the movable loop holder 1400. In one modification, the shorter distance can reduce the effective circulating volume of the blood component collection set 500. The shorter distance reduces waste, for example, in the materials used to manufacture the blood component collection set 500, or in the blood components remaining in the blood component collection set 500 after use. The shorter distance allows for control over the length of the flexible loop 524 so that it does not become entangled or snagged, and / or can be properly and securely fitted within the apheresis system 200.

[0184] The movable loop holder 1400 is movable (using an automatic or manual process) between a first state, i.e., an operational or extended state (see, for example, Figures 14A, 14B, and 14D), and a second state, i.e., a fitted or retracted state (see, for example, Figure 14E). For example, the movable loop holder 1400 is movable (along the x-axis) from an extended position near the first side, i.e., the front portion 202, of the apheresis system 200 to or toward the second side, i.e., the rear portion 206, of the apheresis system 200. In the extended position, the movable loop holder 1400 is fixedly coupled to the blood component collection loop 520. In the retracted position, the blood component collection loop 520 is detached from or unconnected to the loop holder body 1408. For example, the movable loop holder 1400 includes a release latch 1404. The release latch 1404 is operated (e.g., pulled, released) to unlock the movable loop holder 1400 from a first state, i.e., a locked state, to a second state, i.e., an unlocked state. In the unlocked state, the loop holder body 1408 is moved in a retraction direction 1420 (e.g., away from the front portion 202 of the apheresis system 200 and / or housing 204 towards the rear portion 206). The retraction direction 1420 is defined along both the x and z axes in the XZ plane.

[0185] In at least one exemplary embodiment, the retraction of the movable loop holder 1400 provides clearance for rotating the upper housing 404B from inside the centrifuge chamber 1402 to a position outside the centrifuge chamber 1402, as shown, for example, in Figure 14E (see, for example, Figures 4D, 4E, and 4F). For example, when the loop holder body 1408 moves in the retraction direction 1420, the loop holder body 1408 is positioned outside the filler rotation trajectory arc 1410, shown in Figure 14C as an arched centerline that rotates, for example, around the y-axis. A rotation clearance space 1416 is formed between the loop holder body 1408 and the filler rotation trajectory arc 1410. The rotational clearance space 1416 allows the upper housing 404B to rotate relative to the lower housing 404A (for example, without the upper housing 404B contacting the loop holder body 1408) when the centrifuge split housing 404 moves from the operating state to the mounted state, or vice versa. For example, when the movable loop holder 1400 is in the retracted position, the upper housing 404B can be hinged and turned upside down to mount, for example, the filler 460 together with the blood component collection loop 520 and the blood component collection bladder 536. Once mounted, the upper housing 404B closes and locks into the operating state. Once the upper housing 404B is fixed in the operating position (for example, the upper housing 404B and the lower housing 404A are connected), the moving loop holder 1400 is extended (for example, moved to an extended position) to hold the blood component collection loop 520 in a fixed position relative to the centrifuge assembly 400.

[0186] In at least one exemplary embodiment, when the movable loop holder 1400 is positioned in the extended state, the loop holder body 1408 is separated from the centrifuge assembly 400, including the upper housing 404B, by a first distance 1430A, preventing the upper housing 404B from moving from the operational state to the mounted state and vice versa. For example, when the loop holder body 1408 is separated by a first distance 1430A in the extended state, if the upper housing 404B were to hinge with respect to the lower housing 404A, the upper housing 404B would come into contact with the loop holder body 1408. In order to move the centrifuge assembly 400 between the operational state and the mounted state, the movable loop holder 1400 must first be moved to the retracted state 1400B. When the movable loop holder 1400 is in the retracted position 1400B, for example as shown in Figure 14C, the retracted loop holder body 1408' is separated from the centrifuge assembly 400 by a second distance 1430B. The second distance 1430B is greater than the first distance 1430A and defines a rotational clearance space 1416 between the loop holder body 1408 and the filler rotation trajectory arc 1410. The filler rotation trajectory arc 1410 corresponds to the path of the outermost portion of the upper housing 404B when the upper housing 404B hinges around the split housing pivot axis 406 (for example, relative to the lower housing 404A). When the movable loop holder 1400 is in the retracted position 1400B, the upper housing 404B can hinge rotate relative to the lower housing 404A without contacting the loop holder body 1408.

[0187] In at least one exemplary embodiment, the apheresis system 200 cannot operate when the movable loop holder 1400 is in the retracted state 1400B. The apheresis system 200 can only operate when the movable loop holder 1400 is in the extended state. For example, the apheresis system 200 includes one or more sensors. These sensors are configured to detect the position of the movable loop holder 1400 and, based on the detected position, provide an input to the controller of the apheresis system 200 containing information about the position of the movable loop holder 1400. In response, the controller restricts the operation of the apheresis system 200 when the movable loop holder 1400 is in the retracted state and enables the operation of the apheresis system 200 when the movable loop holder 1400 is in the extended state.

[0188] A portion of the blood component collection set 500 is mounted to the apheresis system 200 by moving the movable loop holder 1400 to the retracted position 1400B and hinge-rotating the upper housing 404B to the mounting position (see, for example, Figures 4F and 6A). In at least one exemplary embodiment, when the upper housing 404B is open and in the mounting position, at least a portion of the upper housing 404B extends outside the centrifuge chamber 1402. In this "inverted" mounting position, the inverted upper housing 404B provides clearance for mounting the blood component collection bladder 536 into the filler 460 (e.g., located within the upper housing 404B) as described above, and makes it accessible during mounting. Once the blood component collection loop 520 is connected to the filler 460 or otherwise coupled, the upper housing 404B is hinge-rotated from the mounting position to the operating position (see, for example, Figure 6C). At this position, the movable loop holder 1400 is moved from the retracted state 1400B to the extended state (see, for example, Figure 14C), and the system fixed loop connector 528 of the blood component collection loop 520 is interconnected with the loop connection space 1412 of the loop holder body 1408. The removal of the filler 460 is performed by reversing the above sequence of operations. For example, removing the filler 460 and / or the centrifuge assembly 400 includes separating the system fixed loop connector 528 from the loop connection space 1412 and moving the loop holder 1400 from the extended state to the retracted state 1400B. When in the retracted state 1400B, the upper housing 404B is rotated or hinged from the operating position to the open mounting position. In the open position, the blood component collection loop 520 is disconnected from and removed from the filler 460. The installation and removal process is repeated each time the apheresis system 200 is used, i.e., operated, in order to re-install the filler 460 and / or the centrifuge assembly 400.

[0189] In at least one exemplary embodiment, the Disclosure provides an apheresis system. The apheresis system comprises a housing having a front portion and a rear portion; a centrifuge chamber disposed within the housing; a centrifuge assembly disposed within the centrifuge chamber; and a movable loop holder disposed within the centrifuge chamber, the movable loop holder comprising a loop holder body and a loop connection space disposed within the loop holder body. The loop connection space may be sized to accommodate a connector for a flexible loop. The movable loop holder may be movable between an extended state and a retracted state within the centrifuge chamber, in the extended state the loop holder body being positioned at a first distance from the centrifuge assembly, and in the retracted state the loop holder body being positioned at a second distance from the centrifuge assembly, the second distance being greater than the first distance. In at least one exemplary embodiment, the centrifuge assembly may have a centrifuge housing, the centrifuge housing may include a mounted state and an operating state. When the movable loop holder is in the extended state, the centrifugal separator housing is prevented from moving from the operating state to the mounted state, and when the movable loop holder is in the retracted state, the centrifugal separator housing is allowed to move from the operating state to the mounted state. In at least one exemplary embodiment, the centrifugal separator housing has a split housing including a lower housing portion and an upper housing portion, the upper housing portion hinges with respect to the lower housing portion, and the upper housing portion hinges along an arc when moving between the operating state and the mounted state. In at least one exemplary embodiment, when the movable loop holder is in the retracted state, a clearance space may be formed between the loop holder body and the arc to provide a path of movement along the arc that the upper housing portion follows when hinges with respect to the lower housing portion between the operating state and the mounted state without the loop holder body.In at least one exemplary embodiment, when the movable loop holder is in the extended state, the clearance space between the loop holder body and the arc is eliminated, preventing the upper housing portion from hinge-rotating relative to the lower housing portion between the operating state and the mounted state. In at least one exemplary embodiment, when the movable loop holder is in the retracted state, the loop holder body is positioned closer to the rear portion of the housing than when the movable loop holder is in the extended state. In at least one exemplary embodiment, the loop holder body may include a connector lock portion that engages with the connector of the flexible loop to lock the flexible loop against the loop holder body and the loop connection space. In at least one exemplary embodiment, the movable loop holder includes a loop holder body and a loop connection space located within the loop holder body. The loop connection space is sized to receive the connector of the flexible loop of the blood component collection set. The movable loop holder may be movable between an extended state and a retracted state within the centrifugal chamber of the apheresis system, in the extended state, the loop holder body being positioned at a first distance from the centrifugal assembly located within the centrifugal chamber, and in the retracted state, the loop holder body being positioned at a second distance from the centrifugal assembly located within the centrifugal chamber, the second distance being greater than the first distance. In at least one exemplary embodiment, the loop holder body may include a connector locking portion that engages with the connector of the flexible loop to lock the flexible loop against the loop holder body and the loop connection space.

[0190] In at least one exemplary embodiment, a method is provided for mounting a centrifuge filler in an apheresis system. The method includes providing an apheresis system comprising a housing having a front portion and a rear portion, a centrifuge chamber disposed within the housing, a centrifuge assembly disposed within the centrifuge chamber, and a movable loop holder disposed within the centrifuge chamber. The centrifuge assembly has a split housing including a lower housing portion and an upper housing portion, the upper housing portion hinges to rotate relative to the lower housing portion. The centrifuge housing includes a mounted state and an operating state. The movable loop holder includes a loop holder body and a loop connection space disposed within the loop holder body. The loop connection space may be sized to receive a connector for a flexible loop. The movable loop holder may be movable between an extended state and a retracted state within the centrifuge chamber, in the extended state the loop holder body is positioned at a first distance from the centrifuge assembly, and in the retracted state the loop holder body is positioned at a second distance from the centrifuge assembly, the second distance being greater than the first distance. The upper housing portion rotates on a hinge along an arc as it moves between the operating state and the mounted state, preventing the split housing from moving from the operating state to the mounted state when the movable loop holder is in the extended state, and allowing the split housing to move from the operating state to the mounted state when the movable loop holder is in the extended state.The present method for mounting a centrifuge filler further includes: activating a release latch to unlock the movable loop holder from a locked state to an unlocked state; moving the movable loop holder from an extended state to a retracted state; with the movable loop holder in the retracted state, hinge-rotating the upper housing portion relative to the lower housing portion so that the upper housing portion is at least partially positioned outside the centrifuge chamber and the upper housing portion is in the mounted state; with the upper housing portion in the mounted state, coupling the blood component collection bladder and the flexible loop of a blood component collection set to the filler positioned in the upper housing portion; hinge-rotating the upper housing portion relative to the lower housing portion so that the upper housing portion is positioned inside the centrifuge chamber and the upper housing portion is in the operating state when the movable loop holder is in the retracted state; and moving the movable loop holder from the retracted state to the extended state and locking the movable loop holder in the locked state with the release latch.

[0191] Example of a bottle tray with magnetic coupling and load cell overload protection Figures 15A to 15M are various diagrams showing a load cell assembly and its components according to at least one exemplary embodiment. Figure 15A is a perspective view of a load cell assembly according to at least one exemplary embodiment. Figure 15B is an exploded perspective view of the load cell assembly of Figure 15A according to at least one exemplary embodiment.

[0192] In at least the exemplary embodiments shown, the load cell assembly 1500 is a bottle tray load cell assembly. The load cell assembly 1500 has a fixed portion, a flexible portion (Figure 15B), and a load cell 1506. In at least one exemplary embodiment, the fixed portion includes a plate 1508 (also called the “mount plate”) and a bracket 1510 (also called the “load cell support bracket”). In at least one exemplary embodiment, the flexible portion includes a first component 1512 (also called the “load interface plate”), a second component 1514 (also called the “overload support bar”), and a cradle 1516 (also called the “bottle cradle” or “plasma collection cradle”). The load cell assembly 1500 extends along a central axis or longitudinal axis 1517. In at least one exemplary embodiment, the longitudinal axis 1517 passes through the center of the load cell 1506.

[0193] In at least one exemplary embodiment, the cradle 1516 may be similar to the plasma collection cradle 232C in Figure 2A. The plasma collection cradle 1516 may be attached to the overload support bar 1514. As described above, the plasma collection cradle 1516 is configured to receive, orient, and / or hold a container such as a plasma collection bottle (e.g., bottle 1598 in Figure 15M or container 2716 in Figure 26J) in an apheresis system such as the apheresis system 200 shown in Figure 1. In at least one exemplary embodiment, the load cell 1506 is configured to bend to detect the load and / or weight of the container. The load cell 1506 may be highly sensitive to forces within a predetermined (or desired) range. For example, if the force applied to the load cell 1506 goes outside (e.g., exceeds) a predetermined range, the accuracy of the load measurement and / or the integrity of the load cell 1506 is impaired.

[0194] In at least one exemplary embodiment, the cradle 1516 is coupled to the load cell 1506 via magnetic coupling and interface. The magnetic coupling may be configured to mechanically separate the cradle 1516 from the load cell 1506, thereby reducing or preventing mechanical forces from continuing to be applied to the deflection beam portion and / or the load cell 1506. In at least one exemplary embodiment, as will be described in more detail below, when a predetermined load is reached, the cradle 1516 breaks the magnetic interconnection force, separating the cradle 1516, plate 1508, and second component 1514 from the apheresis system 200. In particular, this magnetic interconnection can reduce or prevent damage to the load cell 1506, sensing components, support elements, deflection beam portion, and / or other mechanical elements positioned between the cradle 1516 and the load cell 1506.

[0195] In at least one exemplary embodiment, the first component 1512 includes a first magnet 1518, and the second component 1514 includes a second magnet 1520. The first magnet 1518 may be coupled to the first component 1512 by a first fastener 1522A. The second magnet 1520 may be coupled to the second component 1514 by a second fastener 1522B. As will be described in more detail below, the load cell 1506 may be coupled to the bracket 1510 by one or more third fasteners 1522C. The first component 1512 may be coupled to the load cell 1506 by one or more fourth fasteners 1522D. The mounting plate 1508 may be coupled to the bracket 1510 by one or more fifth fasteners 1522E. The second component 1514 may be coupled to the cradle 1516 by one or more sixth fasteners 1522F. In at least one exemplary embodiment, the fasteners 1522A, 1522B, 1522C, 1522D, 1522E, and 1522F may be independently selected from flat-head screws, socket head bolts, hex screws, bolts, and the like.

[0196] FIG. 15C is a top perspective view of the mounting plate of the load cell assembly of FIG. 15A according to at least one exemplary embodiment. FIG. 15D is a bottom perspective view of the mounting plate of FIG. 15C according to at least one exemplary embodiment.

[0197] In at least one exemplary embodiment, as shown in FIGS. 15C and 15D, the mounting plate 1508 includes a generally flat planar body 1524 having a first side 1526A and a second side 1526B. The planar body 1524 may define a generally rectangular outer perimeter (e.g., a rectangle with rounded corners).

[0198] In at least one exemplary embodiment, one or more first openings 1528 (e.g., four openings 1528 as shown) are formed in the planar body 1524. Fasteners (not shown) can extend through the first openings 1528 to couple the load cell assembly 1500 (shown in FIGS. 15A and 15B) through the mounting plate 1508 to the afferesis system 200 (shown in FIG. 1). In at least one exemplary embodiment, the bottle tray load cell assembly 1500 can be completely removed from the afferesis system 200 by removal of the fasteners. In particular, this feature enables quick replacement and / or maintenance of the bottle tray load cell assembly 1500 and / or components of the bottle tray load cell assembly 1500, as will be described in more detail below with respect to FIG. 18A.

[0199] In at least one exemplary embodiment, the first flange 1530 extends from the planar body 1524 on the first side 1526A. The first flange 1530 may be rectangular in shape. In at least one exemplary embodiment, the mounting plate 1508 includes a gasket 1532 (shown in Figure 15D) on the first side 1526A. The gasket 1532 may be adjacent to the first flange 1530. When the load cell assembly 1500 (shown in Figures 15A and 15B) is coupled to the apheresis system 200 (shown in Figure 1), the gasket 1532 is located between the planar body 1524 of the plate 1508 and the housing 204 (shown in Figure 2A). In at least one exemplary embodiment, the gasket 1532 may be an O-ring, a flat seal gasket, or other flexible sealing member, or may include them. Furthermore, or alternatively, the gasket 1532 may be an electromagnetic shielding gasket (EMI gasket) (e.g., a metal gasket, a spring, a metallized gasket, etc.), or may include such a gasket.

[0200] In at least one exemplary embodiment, a second opening 1534 is formed in the planar body 1524. The second opening 1534 may be a central opening. In at least one exemplary embodiment, a second flange 1536 may extend from the second side 1526B of the planar body 1524. The second flange 1536 may be a circular flange. The second flange 1536 extends around the second opening 1534. In at least one exemplary embodiment, a portion of the second component 1514 (shown in Figures 15A and 15B) extends through the second opening 1534. The second component 1514 is configured to translate along the longitudinal axis 1517 when the deflection portion of the load cell assembly 1500 (shown in Figures 15A and 15B) deflects. In at least one exemplary embodiment, the amount of deflection is very small, less than or equal to about 0.05 inches (e.g., less than or equal to about 0.01 inches, or less than or equal to about 0.005 inches).

[0201] Figure 15E is a perspective view of the bracket of the load cell assembly shown in Figure 15A, according to one exemplary embodiment.

[0202] In at least one exemplary embodiment, as shown in Figure 15E, the bracket 1510 has a wall 1538 and a third flange 1540. The third flange 1540 includes a first flange portion 1540A and a second flange portion 1540B. The first and second flange portions 1540A and 1540B may be spaced apart from each other. The first and second flange portions 1540A and 1540B each include upper surfaces 1541A and 1541B, respectively. The upper surfaces 1541A and 1541B may be coplanar.

[0203] In at least one exemplary embodiment, a receptacle 1542 is formed in the wall 1538. The receptacle 1542 has a substantially rectangular shape. The receptacle 1542 can receive at least a portion of the load interface plate 1512 and / or at least a portion of the overload support bar 1514, as shown in Figure 15I.

[0204] A recess 1543 may be further formed in the wall 1538. The recess 1543 may have a semi-cylindrical shape. The recess 1543 may extend between the receptacle 1542 and the upper surface 1544 of the wall 1538. As shown in Figure 15I, the recess can receive at least a portion of the overload support bar 1514.

[0205] In at least one exemplary embodiment, the bracket 1510 further includes a gusset plate 1546 extending between the wall 1538 and the third flange 1540. In at least one exemplary embodiment, the wall 1538, the third flange 1540, and the gusset plate 1546 may cooperate to define an internal bracket region 1547. In at least one exemplary embodiment, as will be described in more detail below, the load cell 1506, the first component 1512, and parts of the second component 1514 may be located within the internal bracket region 1547. Therefore, when the mounting plate 1508 is attached to the housing 204 of the apheresis system 200 (shown in Figure 2A), the bracket 1510 is located inside the guarded portion of the apheresis system 200 (for example, protecting the load cell 1506 and / or other components of the load cell assembly 1500 from damage, accidental contact, and / or the external environment of the apheresis system 200).

[0206] In at least one exemplary embodiment, the bracket 1510 is attached to the mounting plate 1508. In the illustrated exemplary embodiment, the bracket 1510 is attached to the first side 1526A of the mounting plate 1508. One or more third openings 1550 are formed in the upper surface 1544 of the wall 1538 of the bracket 1510. A fifth fastener 1522E extends through the third opening 1550 and the plate 1508 to connect the bracket 1510 to the mounting plate 1508. One or more fourth openings 1551 may be formed in the second flange portion 1540B. In at least the illustrated exemplary embodiment, a third fastener 1522C can connect the load cell 1506 (shown in Figures 15A and 15B) to the bracket 1510 by passing through the fourth opening 1551, as will be described in more detail below.

[0207] Figure 15F is a perspective view of a load cell in the load cell assembly of Figure 15A, according to one exemplary embodiment.

[0208] In at least one exemplary embodiment, as shown in Figure 15F, the load cell 1506 includes a fixed end 1552 (or fixed side) and a free end 1554 (or free side or load deflection side). As shown in Figure 15A, the fixed end 1552 is fixed to the bracket 1510. Specifically, the fixed end 1552 of the load cell 1506 contacts the second flange portion 1540B. In at least one exemplary embodiment, the fixed end 1552 of the load cell 1506 may be in direct contact with the second flange portion 1540B. The load cell 1506 may be at least partially within the internal bracket region 1547 of the bracket 1510.

[0209] In at least one exemplary embodiment, the free end 1554 of the load cell 1506 defines a deflection region 1556 (also shown in Figures 15A and 15I) spaced apart from at least a portion of the bracket 1510, such as the first flange portion 1540A. The free end 1554 of the load cell 1506 is configured to move within the deflection region 1556 in response to the application of a force or load in a first direction 1558. The first direction 1558 is substantially parallel to the central axis 1517.

[0210] In at least one exemplary embodiment, the load cell 1506 is a deflection-based load cell. As the free end 1554 moves or translates relative to the fixed end 1552, the load cell 1506 can determine a force, weight, or load associated with the measured deflection. The load cell 1506 is capable of receiving forces perpendicular to the deflection member of the load cell 1506 (e.g., a first direction 1558), but the load cell 1506 may also be sensitive to rotational, torsional, or parallel forces. Examples of load cells 1506, but not limited to, include shear beam load cells, S-beam load cells, single-point load cells, dual shear beam load cells, bending beam load cells, canister load cells, strain gauges, bent load cells, and / or combinations thereof.

[0211] Returning to Figures 15A and 15B, in at least one exemplary embodiment, the load cell assembly 1500 includes a magnetic coupling between the load interface plate 1512 and the overload support bar 1514. In at least the illustrated exemplary embodiment, the load interface plate 1512 includes a first magnet 1518, and the overload support bar 1514 includes a second magnet 1520. The magnets 1518 and 1520 may be arranged such that their opposite poles face each other when the overload support bar 1514 engages with the load interface plate 1512, as shown in Figure 15I. This arrangement allows the magnetic force between the magnets 1518 and 1520 to maintain the overload support bar 1514 engaged with the load interface plate 1512.

[0212] Figure 15G is a perspective view of the load interface plate of the load cell assembly shown in Figure 15A, according to at least one exemplary embodiment.

[0213] In at least one exemplary embodiment, as shown in Figure 15G, the load interface plate 1512 includes an interface body or first cam body 1560 and an extension or mount 1562. The load interface plate 1512 has a first side or load cell side 1564A and a second side or interface side 1564B. A first recess or indentation 1566 is formed in the first cam body 1560. When the load cell assembly 1500 (shown in Figure 15A) is assembled, the load interface shaft 1517A is aligned with the central axis 1517 (shown in Figure 15A). The first magnet 1518 may be at least partially located within the first recess 1566. The load interface shaft 1517A extends through the center of the first recess 1566. The first magnet 1518 (shown in Figure 15B) may be fixed in the first recess 1566 by adhesive, pinning, crimping, or other means. In at least the illustrated exemplary embodiments, the first magnet 1518 may be attached to the overload support bar 1514 via a first fastener 1522A, such as a flat-head screw. In at least one exemplary embodiment, the surface of the first magnet 1518 may be coplanar with or below the first cam surface 1567 of the overload support bar 1514.

[0214] In at least one exemplary embodiment, a plurality of valleys 1568 are formed in the first cam surface 1567. In at least the illustrated exemplary embodiment, the plurality of valleys 1568 include a first valley 1568A, a second valley 1568B, and a third valley 1568C. The valleys 1568 may be arranged asymmetrically around the load interface axis 1517A (for example, their centers are spaced about 90 degrees apart from each other). In at least one exemplary embodiment, each of the valleys 1568 is configured as a dwell or recess having at least one inclined, chamfered, or tapered side surface.

[0215] In at least one exemplary embodiment, a first flat portion 1569 may be further formed on the first cam surface 1677. In the illustrated exemplary embodiment, the first flat portion 1569 is between the first valley portion 1568A and the third valley portion 1568C. The first flat portion 1569 may extend continuously between the first valley 1568A and the third valley 1568C. The valley portions 1568A, 1568B, 1568C and the first flat portion 1569 are circumferentially around the first recess 1566.

[0216] In at least one exemplary embodiment, a plurality of cuts 1570 may be further formed on the second side surface 1564B of the first cam body 1560. Each of the plurality of cuts 1570 corresponds to each one of the valley portions 1568. The cuts 1570 may be centered within each of the respective valley portions 1568.

[0217] The extension portion 1562 is adjacent to the first cam body 1560. In at least the illustrated exemplary embodiment, the extension portion 1562 has a substantially rectangular cross-section. One or more fourth openings 1571 may be formed in the extension portion 1562. The fourth openings 1571 can receive a fourth fastener 1522D to couple the load interface plate 1512 to the load cell 1506 (shown in FIG. 15B).

[0218] FIG. 15H is a perspective view of an overload support bar of the load cell assembly of FIG. 15A, according to at least one exemplary embodiment.

[0219] Referring to FIG. 15H, in at least one exemplary embodiment, the overload support bar 1514 includes a mandrel 1572 that extends longitudinally or in the length direction along a support bar axis 1517B (e.g., coinciding with the axis 1517 of FIG. 15A) from a first end 1573A to a second end 1573B. In at least one exemplary embodiment, the overload support bar 1514 includes a second cam body 1574 at the first end 1573A and a coupling portion 1575 at the second end 1573B.

[0220] In at least one exemplary embodiment, the coupling portion 1575 has a diameter greater than the diameter of the mandrel 1572. The coupling portion 1575 has a receptacle formed in it, such as a fifth opening 1575A. The fifth opening 1575A works in cooperation with a sixth fastener 1522F to connect the cradle 1516 (shown in Figure 15A) to the overload support bar 1514.

[0221] In at least one exemplary embodiment, the second cam body 1574 is substantially cylindrical. A second recess or indentation 1576 is formed in the second cam body 1574. The support bar shaft 1517B extends through the center of the second recess 1576. When the load cell assembly 1500 (shown in Figure 15A) is assembled, the support bar shaft 1517B is aligned with the central axis 1517. The second magnet 1520 may be at least partially located within the second recess 1576. The second magnet 1520 (shown in Figure 15B) may be fixed within the second recess 1576 by adhesive, pinning, crimping, or other means. In at least one illustrated exemplary embodiment, the second magnet 1520 may be attached to the overload support bar 1514 via a second fastener 1522B, such as a flat-head screw. In at least one exemplary embodiment, the surface of the second magnet 1520 may be coplanar with or below the second cam surface 1577 of the overload support bar 1514.

[0222] In at least one exemplary embodiment, a plurality of lobe portions 1578 are formed on the second cam surface 1577. In at least the illustrated exemplary embodiment, the plurality of lobe portions 1578 include a first lobe portion 1578A, a second lobe portion 1578B, and a third lobe portion 1578C. The lobe portions 1578 may be arranged asymmetrically around the support bar axis 1517B (for example, their centers are spaced about 90 degrees apart from each other). In at least one exemplary embodiment, each of the lobe portions 1578 is configured as a projection having at least one inclined or tapered side surface extending from the tip of the projection.

[0223] In at least one exemplary embodiment, a second flat portion 1579 may be further formed on the second cam surface 1577 of the second cam body 1574. In the illustrated exemplary embodiment, the second flat portion 1579 is located between the first lobe portion 1578A and the third lobe portion 1578C. The second flat portion 1579 may extend continuously between the first lobe portion 1578A and the third lobe portion 1578C. The lobe portion 1578 and the second flat portion 1579 are circumferentially located around the second recess 1576.

[0224] In at least one exemplary embodiment, the advantage of the asymmetric arrangement of the lobe portion 1578 and the valley portion 1568 (shown in Figure 15G) is that the overload support bar 1514 can only engage with the load interface plate 1512 in one orientation state (for example, to prevent improper mounting of the plasma collection cradle 1516 onto the apheresis system 200). In at least one exemplary embodiment, in particular, this asymmetric arrangement ensures that the plasma collection cradle 1516 is always mounted in substantially the same orientation as the apheresis system 200.

[0225] In at least one exemplary embodiment, referring to Figures 15G to 15H, the arrangement of the valleys 1568 (Figure 15G) provides at least one mating surface at each position of the valleys 1568 configured to contact the corresponding surface of the lobes 1578 (Figure 15H). When the overload support bar 1514 is engaged with the load interface plate 1512 (for example, when engaged), the first cam lobe 1578A aligns with and enters the first valley 1568A, the second lobe 1578B aligns with and enters the second valley 1568B, and the third lobe 1578C aligns with and enters the third valley 1568C. In at least one exemplary embodiment, the first cam surface 1567 may be in continuous and uninterrupted contact with the second cam surface 1577.

[0226] In at least one exemplary embodiment, when the overload support bar 1514 is tilted, twisted, or rotated relative to the load interface plate 1512 (for example, via an external force applied to the plasma collection cradle 1516 shown in Figure 15A and / or the plasma collection bottles in the plasma collection cradle 1516, etc.), at least a portion of the second cam surface 1577 is disengaged from the first cam surface 1567 (e.g., not in direct contact). In at least this exemplary embodiment, as the overload support bar 1514 rotates about the axis 1517B, one or more of the multiple lobe portions 1578 come into contact with the first flat portion 1569 of the load interface plate 1512.

[0227] Figure 15I is a partial cross-sectional view of the load cell assembly of Figure 15A in the engaged state according to at least one exemplary embodiment. Figure 15J is a partial cross-sectional view of the load cell assembly of Figure 15A in the disengaged state, with a portion of the first magnet cut out, according to at least one exemplary embodiment.

[0228] In at least one exemplary embodiment, as shown in Figures 15I and 15J, each of the magnets 1518 and 1520 has a first pole side 1580A (e.g., a north pole) and a second pole side 1580B (e.g., a south pole). The first pole side 1580A has a first polarity, and the second pole side 1580B has a second polarity opposite to the first polarity. The magnets 1518 and 1520 are arranged such that opposite poles (i.e., poles with opposite polarities) face each other. In the illustrated exemplary embodiment, the first magnet 1518 is located in a first recess 1566 of the load interface plate 1512 such that the first pole side 1580A of the first magnet 1518 faces the overload support bar 1514. The second magnet 1520 is located in the second recess 1576 of the overload support bar 1514 such that the second pole side 1580B of the second magnet 1520 faces the load interface plate 1512. In at least one other exemplary embodiment, the load cell assembly includes a single magnet positioned on the load interface plate or the overload support bar, and a magnetically attractive metal (e.g., iron, steel, etc.) may be positioned on the other of the load interface plate or the overload support bar.

[0229] The bottle tray load cell assembly 1500 can provide overload protection for the load cell 1506 and / or other components by the overload support bar 1514, which moves from an engaged state shown in Figure 15I to an unengaged state shown in Figure 15J when a predetermined movement and / or force is received by the overload support bar 1514. The movement and / or force corresponds to rotation around the central axis 1517 in the rotational direction 1582, a moment around the axis 1517, a moment around the indicated y-axis, a moment around the indicated x-axis, and / or a combination thereof. In particular, the ability of the overload support bar 1514 to be unengaged from the load interface plate 1512 prevents nonlinear forces (e.g., forces acting not only along the z-axis indicating the direction of gravity) from damaging the load cell 1506 and / or components of the bottle tray load cell assembly 1500.

[0230] In at least one exemplary embodiment, as shown in Figure 15J, when subjected to a force in the first rotational direction 1582A, the overload support bar 1514 rotates counterclockwise relative to the load interface plate 1512. This force is caused by accidental contact with and / or accidental rotation of the cradle 1516, causing the overload support bar 1514 to rotate around the axis 1517. As the overload support bar 1514 rotates, the lobe portion 1578 moves along the inclined or tapered side surface of the valley portion 1568, causing the overload support bar 1514 to move upward relative to the load interface plate 1512, resulting in the overload support bar 1514 separating at least partially from the load interface plate 1512. In at least one exemplary embodiment, in the fully disengaged state, the overload support bar 1514 separates from the load interface plate 1512 by a separation distance 1583. In this position, the lobe portion 1578 contacts the first flat portion 1569 of the load interface plate 1512, disengaging from or becoming disengaged from the valley portion 1568.

[0231] When the overload support bar 1514 separates from the load interface plate 1512, a separation space 1584 is formed between the overload support bar 1514 and the load interface plate 1512. This separation space 1584 can create a sufficient gap between the first and second magnets 1518, 1520 so that a rotational force continuously applied to the overload support bar 1514 does not exert any particular force (e.g., torsion, rotation, and / or moment) on the load interface plate 1512. In at least one exemplary embodiment, the magnetic force between the magnets 1518, 1520 when disengaged (e.g., due to a partial separation distance 1583) is less than the magnetic force between the magnets 1518, 1520 when engaged (as shown in Figure 15I). Thus, the load cell 1506 is protected from continuously applied rotational or moment forces. To reset the bottle tray load cell assembly 1500, rotate the overload support bar 1514 until the lobe portion 1578 aligns with the valley portion 1568, the overload support bar 1514 moves toward the load interface plate 1512, and the separation distance 1583 decreases and / or closes.

[0232] Figure 15K is a side view of the cradle of the load cell assembly shown in Figure 15A, according to at least one exemplary embodiment.

[0233] In at least one exemplary embodiment, as shown in Figure 15K, the cradle 1516 has a wall 1586 that at least partially defines a container area 1587. The wall 1586 may be partially cylindrical. A cap 1588 may be coupled to the wall 1586 to facilitate the alignment and / or retention of a container within the container area 1587. In at least one exemplary embodiment, the cap 1588 facilitates the proper removal of a container from the cradle 1516 (see, for example, container 1598 in Figure 15M) by lifting the port end or top of the container ahead of the bottom of the container. This reduces or prevents leakage of the container contents from the container's vent port.

[0234] The wall 1586 extends between a first end 1586A and a second end 1586B. In at least one exemplary embodiment, the second end 1586B of the wall 1586 includes a pair of alignment surfaces 1589. The alignment angle 1590 is defined between the alignment surfaces 1589. In at least one exemplary embodiment, the alignment angle 1590 is about 90 degrees or more (e.g., about 100 degrees or more, about 110 degrees or more, about 120 degrees or more, about 130 degrees or more, about 140 degrees or more, or about 150 degrees or more). The alignment angle 1590 may be about 160 degrees or less (e.g., about 150 degrees or less, about 140 degrees or less, about 130 degrees or less, about 120 degrees or less, about 110 degrees or less, or about 100 degrees or less). The alignment surfaces 1589 cooperate to define at least partially the alignment area 1591. In at least one exemplary embodiment, the wall 1586 further defines a slot 1592 between the alignment surfaces 1589. The alignment surfaces 1589 and / or the slot 1592 facilitate proper alignment of the container in the cradle 1516, as will be described in more detail below, in at least one exemplary embodiment.

[0235] In at least one exemplary embodiment, one or more receptacles 1586C are formed in the wall 1586. The receptacles 1586C are configured to receive at least a portion of a calibration weight. In at least the illustrated exemplary embodiment, the receptacles 1586C are sized to receive the bottom of a cylindrical calibration weight. When the cylindrical calibration weight is at least partially inside the receptacle 1586C, the longitudinal axis of the cylindrical calibration weight is substantially parallel to the central axis 1517 (shown in Figure 15A) of the load cell assembly 1500 (shown in Figure 15A).

[0236] Figure 15L is a front view of the cradle of Figure 15K according to at least one exemplary embodiment.

[0237] In at least one exemplary embodiment, the cradle 1516 may be configured to hold the container in a desired orientation, as shown in Figure 15L. The cradle 1516 defines a container angle 1594 between the bottom of the wall 1586 and a horizontal plane 1595 (i.e., a plane perpendicular to the direction of gravity). In at least one exemplary embodiment, this angle is greater than about 0 degrees (e.g., about 1 degree or more, about 2 degrees or more, about 3 degrees or more, about 5 degrees or more, or about 10 degrees or more). The container angle 1594 may be about 45 degrees or less (e.g., about 40 degrees or less, about 35 degrees or less, about 30 degrees or less, about 25 degrees or less, about 20 degrees or less, about 15 degrees or less, about 10 degrees or less, about 8 degrees or less, or about 5 degrees or less).

[0238] Figure 15M is a perspective view of the container in the cradle of Figure 15K according to at least one exemplary embodiment.

[0239] In at least one exemplary embodiment, as shown in Figure 15M, the cradle 1516 is configured to hold the container in a desired orientation. In at least the exemplary embodiment shown, the container is a bottle 1598. Bottle 1598 may be similar to or the same as bottle 1900 in Figure 19A. Bottle 1598 has a cap 1598A. Cap 1598A has a projection 1598B including a pair of container-aligning surfaces 1598C, a pair of side surfaces 1598D, and an opposing surface 1598E. Cap 1598A further has a fluid port 1598F and a vent port 1598G. In at least one exemplary embodiment, when bottle 1598 is placed in the cradle 1516 for use, the vent cap 1598H is removed from the vent port 1598G, and the tube and connector are connected to the fluid port 1598F (see, for example, Figures 19I and 19J).

[0240] In at least one exemplary embodiment, when the bottle 1598 is properly positioned within the cradle 1516, the projection 1598B is positioned, at least partially, within the alignment area 1591. The alignment surface 1589 of the cradle 1516 engages with (e.g., directly contacts) the container alignment surface 1598C, and the fluid port 1598F is positioned, at least partially, within the slot 1592. Thus, the vent port 1598G is positioned higher than the fluid port 1598F, i.e., above a predetermined (or desired) liquid level. In this arrangement, the filling capacity of the bottle 1598 is increased or maximized compared to other arrangements because positioning the vent port 1598G at the top allows for a larger filling volume without the contents overflowing through the vent port 1598G. Furthermore, this arrangement can reduce or minimize residual volume so that the fluid can be drawn back from the bottle 1598 without drawing in air. The container 1598 is positioned at a container angle 1594. The container angle 1594 may be chosen to balance the required residual volume with a high filling volume.

[0241] In at least one exemplary embodiment, as will be described in more detail below with reference to Figure 26J, the bottle 1598 and / or cap 1598A may be molded to a size such that the cap 1598A of the bottle 1598 is reliably and properly positioned below the bottom of the bottle 1598 in the cradle 1516. That is, the cap 1598A is positioned toward the first end wall 1586A, and the bottom of the bottle 1598 is positioned toward the second end wall 1586B.

[0242] In at least one exemplary embodiment, the bottle 1598 and cradle 1516 include one or more functional parts to facilitate visual identification of improper mounting. The user can easily identify when the bottle 1598 is positioned at an angle other than the container angle 1594 (Figure 15K), i.e., when the longitudinal axis of the bottle 1598 is not parallel to the cradle 1516. In addition or alternatively, the user can easily identify when the container alignment surface 1598C is not fully seated on the alignment surface 1589 of the cradle 1516. In addition or alternatively, the user can identify when the ports 1598F, 1598G are not vertically aligned with the fluid port 1598F in the slot 1592. In addition or alternatively, the user can identify when the label 1598I of the bottle 1598 is not visible, facing upwards, and / or positioned approximately in the center within the cradle 1516.

[0243] On the other hand, in at least one exemplary embodiment, when the bottle 1598 is improperly oriented within the cradle 1516, the opposing surface engages with one or both of the alignment surfaces 1589. This prevents the protrusion 1598B from being within the alignment region 1591. In the improper orientation, the fluid may be forced out of the bottle 1598 through the vent port 1598G, which is below the liquid level in the improper orientation. If the flow is reversed, air, rather than the intended fluid, will be drawn out of the bottle 1598.

[0244] An exemplary embodiment relates to a bottle tray load cell assembly, the bottle tray load cell assembly comprising a support bracket, a load cell including a fixed side and a load deflection side offset from the fixed side, the fixed side of the load cell being attached to the support bracket, and an interface plate attached to the load deflection side of the load cell, the interface plate including a body, a first magnet recess disposed in the body, and a plurality of cam lobe valleys at least partially disposed around the first magnet recess, the plurality of cam lobe valleys interfering with the first contact surface of the body, the interface plate, a mandrel, a cam body, a second magnet recess, and a plurality of cam lobes. The device comprises a support bar, the mandrel extending along its longitudinal axis from a first end to a second end, the cam body positioned at the second end of the mandrel, the second magnet recess positioned at the cam body, the plurality of cam lobes extending from the cam body, the plurality of cam lobes positioned at least partially around the second magnet recess, the support bar movable between an engaged state and a disengaged state with respect to the interface plate, in the engaged state the plurality of cam lobes are positioned in contact with the plurality of cam lobe valleys, and in the disengaged state the plurality of cam lobes are positioned without contact with the plurality of cam lobe valleys and in contact with the first contact surface of the body.

[0245] Any one or more of the above embodiments further comprises: a first magnet disposed in a first magnet recess and having a first magnetic pole having a first polarity, wherein the first magnetic pole is oriented in the direction opposite to the direction toward the body of the interface plate; and a second magnet disposed in a second magnet recess and having a second magnetic pole having a second polarity, wherein the second magnetic pole is oriented in the direction opposite to the direction toward the cam body of the support bar, wherein the first magnetic pole faces the second magnetic pole and the first polarity is opposite to the second polarity. In any one or more of the above embodiments, the support bar is maintained in an engaged state with the interface plate by the magnetic force between the first magnet and the second magnet, and the first movement of the support bar relative to the interface plate moves the support bar away from the interface plate by a certain distance, moving the support bar from an engaged state with the interface plate to a disengaged state from the interface plate. In any one or more of the above embodiments, the first motion includes rotational motion about a longitudinal axis, and the rotational motion includes a force greater than the magnetic force. In any one or more of the above embodiments, the collection cradle is further fixedly attached to the first end of the mandrel. In any one or more of the above embodiments, the load deflection side moves independently of the support bracket. In any one or more of the above embodiments, the plurality of cam lobe valleys includes at least three cam lobe valleys arranged asymmetrically around an axis extending through the center of the first magnet recess, and the plurality of cam lobes includes at least three cam lobe valleys. In any one or more of the above embodiments, the at least three cam lobe valleys engage with the at least three cam lobe valleys only when there is only one rotational arrangement around the axis extending through the center of the first magnet recess. In any one or more of the above embodiments, the support bar rotates about the longitudinal axis without imparting a rotational force to the load cell via the interface plate when disengaged.

[0246] An exemplary embodiment is a method for disengaging a support member from a weighing scale assembly, the method comprising the steps of preparing a load cell assembly, the load cell assembly comprising a support bracket, a load cell including a fixed side and a load-deflection side offset from the fixed side, the fixed side of the load cell being attached to the support bracket, an interface plate attached to the load-deflection side of the load cell, the interface plate including a body, a first magnet recess disposed in the body, and a plurality of cam lobe valleys at least partially disposed around the first magnet recess, the plurality of cam lobe valleys interfering with a first contact surface of the body, the mandrel extending along its longitudinal axis from a first end to a second end, the cam body disposed at the second end of the mandrel, the second magnet recess disposed in the cam body, the plurality of cam lobe valleys extending from the cam body, and the plurality of cam lobe valleys at least partially The present invention provides a load cell assembly comprising the steps of: preparing a load cell assembly in which a support bar is arranged around a second recess for magnets, and the support bar is movable between an engaged state and a disengaged state with respect to the interface plate, wherein in the engaged state, the plurality of cam lobe portions are positioned in contact with the plurality of cam lobe valleys, and in the disengaged state, the plurality of cam lobe portions are positioned without contact with the plurality of cam lobe valleys and in contact with a first contact surface of the main body; positioning the support bar in an engaged state with the interface plate in which the plurality of cam lobe portions are positioned in contact with the plurality of cam lobe valleys; moving the support bar from an engaged state to a disengaged state by the support bar receiving a force that moves the support bar, wherein the force that moves the support bar includes a rotational force about a longitudinal axis; and moving the support bar in the disengaged state independently of the interface plate and without applying any specific rotational force to the interface plate and the load cell.

[0247] Examples of communication methods for apheresis systems In at least one exemplary embodiment, the apheresis system 200 described herein comprises one or more computer systems, such as computer system 1627. The processor 1630 of computer system 1627 is configured to perform one or more of the processes and methods described herein. The processor 1630 may also perform software, for example, which includes firmware, applications, and / or an operating system that manages the execution of the apheresis system 200.

[0248] The software for the Apheresis System 200, including its firmware, applications, operating system, and other programmable functional components, will be updated from time to time as needed to ensure that the Apheresis System 200 operates correctly.

[0249] The apheresis system 200 may, in particular, include applications that perform fleet management and enable customers to install software on a group of devices in bulk. The software system implemented by the apheresis system 200 may be configured to generate and / or compile device logs (D-logs) for transmission to a cloud storage location. The D-logs may be used for predictive analytics or other purposes. Each apheresis system 200 may communicate with a remote system server 1621 (e.g., via a communication network 1618 in the cloud) as shown in Figure 16B. During startup, each apheresis system 200 communicates software information, including firmware version, encountered error logs, etc., with the server 1621 using a method as shown in Figure 16A.

[0250] The system server 1621 is configured to determine whether the software and / or firmware version of the apheresis system 200 requires an update (e.g., is expired). In at least one exemplary embodiment, the system server 1621 may automatically perform the software and / or firmware update, or it may present the user with an option to update the software and / or firmware. In at least one exemplary embodiment, an external device may be connected to the apheresis system 200 to update the software. For example, the external device may be a computer or laptop connected to the apheresis system 200 and configured to update the software of the apheresis system 200. In any case, if the software for the apheresis system 200 is not updated, the apheresis system 200 is rendered inoperable. Such an inoperable state is based on a lock signal transmitted by the system server 1621, or transmitted by the apheresis system 200, which has not received an unlock signal that enables operation, which is transmitted from the system server 1621.

[0251] The method shown in Figure 16A begins at 1600, at which point the apheresis system 200 is in an off or unused state. At 1603, the apheresis system 200 is powered on and the power-up process is performed. A computer system 1627, as shown in Figure 16D, may be configured to detect the startup of the apheresis system 200, or it may be configured to automatically perform a process as described herein at startup.

[0252] In response to detecting a startup, the computer system 1627 may send data to the server 1621 via a connection to the network 1618, as shown in Figure 16B. The data sent to the server 1621 includes one or more of the following: a data log, a firmware version identifier, and an error log.

[0253] In 1609, the apheresis system 200 receives a response from server 1621 in response to data sent to server 1621. Server 1621 is configured to determine, based on the data, whether the software of the apheresis system 200 is the current version and / or the latest version. If the software is outdated or not the current version, server 1621 sends a lockout signal or other type of data packet instructing the apheresis system 200 to update its software before use. In at least one exemplary embodiment, the apheresis system 200 cannot be used until a positive confirmation that the software is up to date is received from server 1621 via network connection 1618. In this way, the risks associated with using an outdated apheresis system 200 can be avoided. For example, in 1612, based on the response received from the server, use of the apheresis system 200 is stopped.

[0254] In at least one exemplary embodiment, if server 1621 determines that the software has not been updated, the server may, as part of its response, send one or more files for updating the software. In addition to or instead of this, the software of the apheresis system 200 may be updated automatically. For example, the software update may start automatically after receiving one or more files for updating the software from the server. In at least one exemplary embodiment, the apheresis system 200 may allow a user to manually update the system when one or more files for updating the software have been received. For example, a user may manually start a software update after receiving one or more files. Once the software is updated, the apheresis system 200 is configured to unlock and allow the use of the system.

[0255] In at least one exemplary embodiment, the method shown in Figure 16A may further include determining whether unlocking requirements have been met after the apheresis device has been taken out of use. For example, the unlocking requirements may include appropriately updating the software. In response to determining that the unlocking requirements have been met, the apheresis system 200 becomes available for use.

[0256] In at least one exemplary embodiment, a message may be displayed on the graphical user interface 1624 of the apheresis system 200, as shown in Figure 16C. The message informs the user whether the apheresis system 200 is locked due to expired software and, if necessary, allows the user to manually install an update to the software. In at least one exemplary embodiment, the user may manually initiate the installation of an update to the software using the graphical user interface (GUI) 1624. In other embodiments, the user may connect an external device containing the software update to the apheresis system 200 to initiate and install the software update.

[0257] At least one exemplary embodiment relates to a method that includes detecting the activation of an apheresis device, sending data to a server in response to the activation detection, receiving a response from the server in response to the data, and stopping the use of the apheresis device based on the response from the server.

[0258] In an embodiment of the above, the data transmitted to the server includes one or more of the following: a data log, a firmware version identifier, and an error log. In an embodiment of the above, the response includes a lockout signal. In an embodiment of the above, the response includes a firmware update. In an embodiment of the above, the firmware update is installed automatically. In an embodiment of the above, the apheresis device releases the suspension of use after the firmware update has been installed. In an embodiment of the above, the firmware update is installed manually by the user. An embodiment of the above includes displaying a message on a graphical user interface based on a response from the server. In an embodiment of the above, the graphical user interface allows the user to initiate a firmware installation. An embodiment of the above includes determining that the unlock requirement has been met after the apheresis device has been deactivated, and enabling the use of the apheresis device in response to the determination that the unlock requirement has been met. In an embodiment of the above, the unlock requirement is associated with the updated firmware.

[0259] Examples of methods and processes for providing feedback during the blood collection process. The apheresis system 200 has one or more interface elements (e.g., a display device, LEDs, alarms, etc.) that provide instructions to the user and / or donor 102 regarding information about the blood collection process. In one example, these interfaces indicate to the donor 102 that pressure should be applied to them (e.g., when the pressure or flow rate falls below a predetermined threshold). In addition to or instead of this, the interface elements can indicate to the donor 102 how far along the blood collection process is. In any case, this feedback is provided by the apheresis system 200 as an audio output and / or visual output (e.g., via one or more speakers, display devices, LEDs, etc.). In at least one exemplary embodiment, LEDs are located on the side of the apheresis system 200 that provides this feedback to the donor 102.

[0260] The method shown in the flowchart of Figure 17A begins at 1700. At the start of this method, the apheresis system, such as apheresis system 200, is powered on and connected to a donor, such as donor 102.

[0261] In 1703, the computer system of the apheresis system 200 detects the start of the blood collection process. In at least one exemplary embodiment, detection itself is not required, and instead, the method illustrated in Figure 17A may be performed automatically as part of the blood collection process. For example, detecting the start of the blood collection process may include initiating the blood collection process. In at least one exemplary embodiment, detecting the start of the blood collection process may include detecting the flow of fluid by using one or more sensors, such as fluid sensor 316.

[0262] In 1706, once the blood collection process has begun, the apheresis system provides an output that is recognizable by the donor 102. For example, the output may be light, sound, a GUI display, etc. The output may be provided with consideration for the donor 102. In at least one exemplary embodiment, as shown in Figure 17B, a side of the apheresis system 200 has an output unit 1724. For example, the output unit 1724 includes a series of light-emitting elements such as light-emitting diodes (LEDs). Although the output unit 1724 is illustrated as being located on a specific side of the apheresis system 200, it should be understood that it may be located on any side of the apheresis system 200, as long as it is within the range of the donor 102 so that the output can be seen or heard by the donor 102.

[0263] In at least one exemplary embodiment, the output unit 1724 may be a display device. For example, the output unit 1724 illuminates or emits light in a manner that visualizes information to the donor or other users of the apheresis system, such as the remaining time in the blood collection process or whether the donor should squeeze their hand to improve blood flow to the apheresis system, or other information. The output unit 1724 may be configured to illuminate or emit light in a pulsed manner, and the rate of the light pulses may be synchronized with the rate at which the donor should squeeze their hand to achieve the optimal flow rate.

[0264] In step 1709, the method determines the percentage of the blood collection process that has been completed and / or is remaining. For example, this includes determining the remaining time for the blood collection process. Determining the remaining time may first include determining the amount of plasma expected to be provided by donor 102. Determining the amount of plasma expected to be provided by the donor may include receiving donor information as part of the initiation process. For example, donor information can be received from the donor's ID card via a reader or scanner such as reader 1221 described above.

[0265] Determining the remaining time involves dividing the expected amount of plasma to be provided by the donor by the expected flow rate. For example, if the apheresis system 200 determines that the expected amount of plasma not yet collected is 1 liter, and the plasma is expected to be collected at a flow rate of 1 liter per minute, the apheresis system 200 can determine that the remaining time for the blood collection process is 1 minute.

[0266] In step 1712, the method updates the output in response to detecting the remaining time in the blood collection process.

[0267] In at least one exemplary embodiment, updating an output such as output unit 1724 involves adjusting the number of light emitters or the proportion of the illuminated portion of the display. For example, as shown in Figures 17C to 17E, output unit 1724 has five light emitters 1727a to 1727e. Each of the five light emitters 1727a to 1727e emits light independently based on the amount of remaining time. Furthermore, as described above, the light emitters 1727a to 1727e may be capable of pulsed emission, i.e., the brightness of each light emitter is independently adjusted so as to achieve the effect of pulsed emission.

[0268] As shown in Figure 17C, each light emitter of the output unit 1724 is turned off or otherwise not illuminated to inform the donor that the blood collection process has just begun. As shown in Figure 17D, a subset of light emitters 1727a to 1727e may be illuminated based on the amount of time remaining relative to the total time of the blood collection process. For example, if the blood collection process is 60% complete, 60% of the light emitters are illuminated. As shown in Figure 17E, all light emitters of the output unit 1724 may be illuminated to inform the donor that the blood collection process is complete or nearly complete. In at least one exemplary embodiment, the color of the light emitters 1727a to 1727e of the output unit 1724 may change when the blood collection process is complete.

[0269] In 1715, the method detects pressure loss. Detecting pressure loss includes detecting that the pressure of the fluid in the apheresis device 200 has fallen below a predetermined threshold. Pressure loss may be due to poor blood circulation in the donor 102, venous collapse, insufficient pump power supply, or other reasons. In some cases, the donor 102 may be required to clench its hand to increase the flow rate to the apheresis system 200. By clenching its hand at a specific rate, the donor 102 can control the flow rate to the apheresis system 200.

[0270] In 1718, in response to detecting a pressure loss, the method updates the output unit 1724. For example, in response to detecting a pressure loss, the apheresis system 200 updates the output unit 1724 so that it instructs the donor 102 to grasp its hand. Updating the output unit 1724 to instruct the donor to grasp its hand may include flashing, for example, turning one or more of the light emitters 1727a to 1727e on and off. In at least one exemplary embodiment, the brightness of one or more of the light emitters 1727a to 1727e is pulsed at a specific rate. The rate at which the light emitters pulse or flash is based on a specific flow rate required to complete the blood collection process.

[0271] At 1721, the method terminates when blood collection is complete. In at least one exemplary embodiment, terminating the method may include detecting the completion of the blood collection process. Terminating the method may include turning off the output unit 1724. For example, after detecting and completing the blood collection process, the apheresis system 200 executes an output routine to indicate to the donor 102 that the blood collection process is complete. Such an output routine may include one or more of the following: flashing the light emitter of the output unit 1724 in a specific sequence, changing the color of the light emitter of the output unit 1724, generating noise, or producing other recognizable output. This can indicate to the donor 102 that the blood collection process is complete. After the output routine, the device or system stops generating noise and turns off the light emitter.

[0272] In at least one exemplary embodiment, during the blood collection process, the apheresis system 200 may be configured to detect alarm events and, in response, warn the user regarding the alarms. For example, during the plasma collection process, a processor in a computer system or microcontroller within the apheresis system 200 may be configured to detect temperature, pressure, flow rate, color, weight, input data from a scanner, or other factors, etc. If any of the factors are in an unreasonable state, such as being too high or too low, the processor may generate a graphic output that alerts the user regarding the alarm event and / or instructs the user on how to resolve the alarm event.

[0273] Detecting alarm events associated with the apheresis system involves monitoring factors such as temperature, pressure, flow rate, fluid color, weight of received plasma, data received from scanners, motor control, centrifuge speed, software failure mode, and / or other factors related to the sampling process.

[0274] Detecting an alarm event involves receiving data from one or more sensors, such as a temperature sensor, pressure sensor, flow sensor, color sensor, valve sensor, weight sensor, scanner, or other device.

[0275] Sensors may be positioned throughout the apheresis system 200 and may be configured to monitor multiple characteristics of the blood collection process, such as the weight of the plasma collection bottle, the flow rate and flow pressure of the tubing, the speed of the centrifuge, and / or other elements.

[0276] An alarm event is detected when one of the factors exceeds or falls below a threshold, or reaches a specific value. The threshold may be an upper or lower threshold, or it may be a specific quantity or range. For example, in the case of an alarm related to the color of a fluid, the threshold may be a specific color or a specific color range.

[0277] The threshold may be related to time or time range. For example, an alarm event may be detected when data received from a scanner, such as donor identification data, is expired or out of date. In at least one exemplary embodiment, an alarm event may be detected when data received from a scanner indicates one or more of the following: expired equipment or device, incorrect equipment or device, and incompatible equipment or device.

[0278] In at least one exemplary embodiment, the alarm event may be based on data from multiple sensors. For example, an alarm event may occur when both pressure and temperature exceed a certain threshold.

[0279] After detecting an alarm, the processor may generate or read a graphical display output based on the detected alarm event.

[0280] Generating a graphical display output may include providing text describing an alarm event, providing one or more images describing an alarm event, and / or providing other content intended to instruct the user on how to resolve the alarm.

[0281] Reading graphical display output may include reading from memory one or more of the following: text describing an alarm event, one or more images describing an alarm event, and / or other content intended to instruct the user on how to resolve the alarm.

[0282] The instructions include at least one instruction to transition the apheresis system 200 from an alarm state to an operational state. The instruction to transition the apheresis system 200 from an alarm state to an operational state may include visual aids and / or text to inform the user of what steps can be taken to resolve the problem causing the alarm event. For example, the instructions may include information instructing the user to perform one or more of the following: connecting a tube, closing a latch, and removing any kinks in the tube. In at least one exemplary embodiment, the instructions may include instructing the user to terminate the blood collection process and disconnect the apheresis system 200 from the donor.

[0283] After generating and / or reading graphical display output based on detected alarm events, the processor renders the graphical display output to the apheresis system's graphical user interface.

[0284] In at least one exemplary embodiment, the processor may, in addition to rendering a graphical display output to a GUI such as GUI1230 shown in Figure 12B, or alternatively, illuminate one or more light-emitting diodes (LEDs) and / or output an audible sound when an alarm event is detected. The LEDs may be switchable between several colors, such as orange, yellow, red, and cyan. The color of the LEDs may be selected by the processor to correspond to the type of alarm event detected. In at least one exemplary embodiment, the LEDs may include one or more light-emitting elements 2339, as described below with respect to Figure 22C.

[0285] In at least one exemplary embodiment, each color may be associated with a different type and / or level of alarm. For example, the type of alarm may indicate that the alarm is associated with one or more of temperature, pressure, flow rate, color, and weight.

[0286] The alarm level may indicate, for example, the severity or priority of the alarm. In at least one exemplary embodiment, different thresholds may be used to determine whether a particular factor is at a mild or severe level. For example, if the normal pressure is 10 PSI, a mild level alarm may be set for pressures below 5 PSI, and a severe level alarm may be set for pressures of zero PSI. In at least one exemplary embodiment, a high-severity alarm may be red. In at least one exemplary embodiment, an intermediate-priority alarm may be yellow or orange. In at least one exemplary embodiment, a low-priority alarm may be green or blue. In at least one exemplary embodiment, if no alarm event is detected, the light is off or does not emit light.

[0287] In at least one exemplary embodiment, the severity or priority level of an alarm may be indicated by flashing or strobe lights. The speed at which the lights flash may also indicate the severity of the alarm. For example, lights flashing at a faster speed or tempo indicate higher severity and priority, while lights flashing at a slower speed or tempo indicate lower priority.

[0288] In at least one exemplary embodiment, an audible alarm or sound indicates the severity or priority level of an alarm event. For example, different sounds, sound patterns, and sound frequencies may indicate priority levels. For instance, higher frequency sounds may indicate higher priority alarm events, and lower frequency sounds may indicate lower priority alarm events. In at least one exemplary embodiment, the rate at which the sound is emitted may indicate the severity level of an alarm event. For example, sounds that occur more frequently within a period of time, such as beeps, may indicate higher priority alarm events.

[0289] The alarm color may be set based on both the type and severity of the alarm. For example, a temperature alarm might be blue, and the brightness or hue of the color may be adjusted based on the severity of the alarm.

[0290] In at least one exemplary embodiment, the graphical display output may include a timestamp indicating the time when the alarm event occurred.

[0291] In at least one exemplary embodiment, the graphical display may include a description of the alarm and a list of actions to resolve the alarm.

[0292] In at least one exemplary embodiment, the graphical display output may include a diagram associated with the alarm event. For example, a photograph or diagram may be displayed to instruct the user on how to resolve the alarm condition.

[0293] In at least one exemplary embodiment, the graphical display includes GUI elements that allow the user to reset, continue, and terminate the blood collection process.

[0294] In at least one exemplary embodiment, after rendering a graphical display output, the method may include performing a system check. In at least one exemplary embodiment, the system check may be performed continuously throughout the blood collection process. Performing the system check may include polling data associated with the alarm event to determine whether the factor causing the alarm event has returned to a normal level. If the factor causing the alarm event has returned to a normal level, the alarm is resolved and terminated. In at least one exemplary embodiment, the alarm event may prompt the termination of the blood collection process and the disconnection of the donor from the apheresis system 200. In such an embodiment, the system check may determine that the alarm event cannot be resolved or recovered and generate an alarm and / or provide instructions to terminate the blood collection process and disconnect the donor 102.

[0295] For example, if a temperature drop below a predetermined threshold triggers an alarm event, the system check includes determining whether the temperature is above the predetermined threshold.

[0296] At least one exemplary embodiment includes a method comprising: detecting the start of a blood collection process; providing an output in response to the detection of the start of a blood collection process; determining the remaining time of the blood collection process; updating an output in response to the detection of the remaining time of the blood collection process; detecting a pressure loss; updating an output in response to the detection of a pressure loss; detecting the end of a blood collection process; and updating an output in response to the detection of the end of a blood collection process.

[0297] In some embodiments of the above embodiments, the blood collection process is plasma collection using an apheresis device. In some embodiments of the above embodiments, detecting the start of the blood collection process includes detecting the flow of fluid. In some embodiments of the above embodiments, the output is one or more of light and sound. In some embodiments of the above embodiments, the output is provided on the apheresis device side. In some embodiments of the above embodiments, the output is within the range of the donor. In some embodiments of the above embodiments, the output is one or more of being seen and heard by the donor. In some embodiments of the above embodiments, the output is a display device. In some embodiments of the above embodiments, the display device displays a series of lights. In some embodiments of the above embodiments, the series of lights is updated to indicate to the donor the remaining time of the blood collection process. In some embodiments of the above embodiments, the series of lights pulses to instruct the donor to apply pressure. In some embodiments of the above embodiments, the pulses are performed at a tempo associated with the rate at which the donor applies pressure to maintain the pressure. In some embodiments of the above embodiments, detecting pressure loss includes detecting that the pressure of the fluid in the apheresis device has fallen below a predetermined threshold. In some embodiments of the above embodiments, updating the output in response to detecting a pressure loss includes instructing the donor to apply pressure. In some embodiments of the above embodiments, updating the output in response to detecting the end of the blood collection process includes stopping audible noise or turning off the light.

[0298] At least one exemplary embodiment of the present disclosure includes a method comprising detecting an alarm event associated with an apheresis system, reading a graphical display output based on the detected alarm event, and rendering the graphical display output to a graphical user interface of the apheresis system.

[0299] In some embodiments of the above method, the method is carried out by an apheresis system used to perform a plasma collection process. In some embodiments of the above method, an alarm event is associated with one or more of the following factors: temperature, pressure, flow rate, fluid color, amount of excess plasma received, and data received from a scanner. In some embodiments of the above method, the alarm event is associated with expired data received from a scanner. In some embodiments of the above method, an alarm event is detected when one of the above factors falls below / exceeds a threshold. In some embodiments of the above method, detecting an alarm event includes receiving data from one or more sensors. In some embodiments of the above method, reading a graphical display output includes generating a graphical display output. In some embodiments of the above method, the graphical display output includes instructions describing the alarm event. In some embodiments of the above method, the instructions include at least one instruction to transition the apheresis system from an alarm state to an operational state. In some embodiments of the above method, the instructions include instructing the user to do one or more of the following: connect a tube, close a latch, and remove a kink from the tube. Some embodiments of the above method include illuminating a light-emitting diode (LED) when an alarm event is detected. In some embodiments of the above method, the color of the light-emitting diode is selected by the processor to correspond to the type of alarm event detected, the color being selected from orange, yellow, red, and cyan, and the type of alarm being associated with one or more of temperature, pressure, flow rate, color, and weight. Some embodiments of the above method include performing a system check after rendering a graphical display output. In some embodiments of the above method, performing a system check includes polling data associated with the alarm event. In some embodiments of the above method, the graphical display output includes a timestamp indicating the time the alarm event occurred.In some embodiments of the above method, the graphical display output includes a diagram associated with the alarm event. In some embodiments of the above method, the diagram instructs the user to resolve the alarm condition. In some embodiments of the above method, the graphical display includes a description of the alarm and a list of actions to resolve the alarm. In some embodiments of the above method, the graphical display includes GUI elements that allow the user to reset, continue, and terminate the blood collection process.

[0300] Examples of modular maintenance threads (sleds) and interconnections. In at least one exemplary embodiment, the apheresis system (e.g., apheresis system 200 or apheresis system 1800) includes one or more subsystems (e.g., power subassemblies, pneumatic control subassemblies, communication subassemblies, pumps 208, 212, 216, bottle tray load cell assembly 1500, etc.) mounted on a thread or mechanical frame that can be completely separated from the apheresis system for inspection, maintenance, and / or replacement. The modular maintenance thread includes one or more mechanical and / or electrical interconnects, which can be selectively disconnected from the corresponding one or more mechanical and / or electrical interconnects of the apheresis system. Once disconnected, the entire subsystem on a particular modular maintenance thread can be removed from the apheresis system, for example, independently of other subsystems and the modular maintenance thread.

[0301] In at least one exemplary embodiment, the modular maintenance thread may be separated into individual and / or combined subsystem threads. For example, one modular maintenance thread may include multiple pneumatic systems for an apheresis system (e.g., two or more manifolds, valves, etc.), another modular maintenance thread may include multiple electrical systems (e.g., two or more processors, controllers, memory devices, power supplies, wiring harnesses, connectors, etc.), and / or other modular maintenance threads may include electrical subsystems and / or mechanical subsystems that are grouped together based on anticipated and / or past maintenance requirements.

[0302] In at least one exemplary embodiment, one or more of the pumps 208, 212, and 216 (shown in Figure 2A) can be quickly replaced by removing a limited number of fasteners (e.g., screws, bolts, nuts, etc.) associated with each modular maintenance thread. After the fasteners are removed, each entire modular maintenance thread and associated system (e.g., pumps 208, 212, and 216) can be removed from the apheresis system without requiring disassembly of the apheresis system and / or removal of other panels, frames, etc.

[0303] In particular, these modular maintenance threads allow for the rapid isolation of components from the apheresis system, enabling them to be maintained separately. In at least one exemplary embodiment, once a modular maintenance thread is removed from the apheresis system, a different (e.g., new, modified, etc.) modular maintenance thread may be replaced in the apheresis system, and the apheresis system may continue to operate (e.g., while the removed modular maintenance thread is being maintained, returned to manufacture, or repaired / reworked). This approach enables replacement work in the subsystem to be performed in one minute, resulting in improved operability and reduced downtime of the apheresis system, especially compared to the maintenance required for other apheresis systems, which may take several hours or more to maintain.

[0304] Figure 18A is a partially exploded perspective view of an apheresis system including a modular maintenance thread, according to at least one exemplary embodiment.

[0305] In at least one exemplary embodiment, as shown in Figure 18A, the apheresis system 1800 includes one or more modular maintenance threads 1802. The apheresis system 1800 may be similar to the apheresis system 200 in Figure 1. In at least the exemplary embodiment shown, the threads 1802 include a first thread 1802A, a second thread 1802B, a third thread 1802C, a fourth thread 1802D, a fifth thread 1802E, a sixth thread 1802F, a seventh thread 1802G, an eighth thread 1802H, and a ninth thread 1802I (collectively referred to as “threads 1802”). The apheresis system 1800 may further include a base assembly 1804, which may define a plurality of receptive spaces. The receptive space 1806 is defined on any surface (or more surfaces) of the base assembly 1804, including the top, side, and / or back. Each of the threads 1802 may be at least partially within one of the receptive spaces 1806. Each of the threads 1802 includes a modular frame configured to selectively engage with the apheresis system, as will be described in more detail below.

[0306] In at least one exemplary embodiment, the base assembly 1804 includes a housing 1804A and a frame 1804B. The housing 1804A may be made of plastic, and the frame 1804B may be made of metal. In at least one other exemplary embodiment, the base assembly may include a one-piece housing and frame. In at least one exemplary embodiment, the housing 1804A includes a sloped or opposed region 1807 around part or all of the receiving space 1806. The sloped or contoured region 1807 is configured to direct fluid away from the threads 1802 (e.g., the gasket 1818 of the threads 1802) in order to reduce or prevent fluid accumulation near the gasket 1818 and / or to facilitate cleaning of the housing 1804A.

[0307] In at least one exemplary embodiment, the first modular maintenance thread 1802A includes a suction pump. The suction pump may be similar to or identical to the suction pump 208 in Figure 2A. The suction pump may be configured to have power connections, telecommunications connections, and pneumatic connections to the base assembly 1804. The first modular maintenance thread 1802A includes a perimeter gasket or fluid gasket and a shielding component configured to engage with the base assembly 1804.

[0308] In at least one exemplary embodiment, the second modular maintenance thread 1802B includes a return pump. The return pump may be similar to or the same as the return pump 212 in Figure 2A. The return pump may be configured to have power connections, telecommunications connections, and pneumatic connections to the base assembly 1804. The second modular maintenance thread 1802B includes a perimeter gasket or fluid gasket and a shielding component configured to engage with the base assembly 1804.

[0309] In at least one exemplary embodiment, the third modular maintenance thread 1802C includes an AC pump. The AC pump may be similar to or identical to the AC pump 216 in Figure 2A. The AC pump may be configured to have power connections and telecommunications connections to the base assembly 1804. The third modular maintenance thread 1802C includes a perimeter gasket or fluid gasket and a shielding component configured to engage with the base assembly 1804.

[0310] In at least one exemplary embodiment, the fourth thread 1802D includes a fluid valve control system. The fluid valve control system may be similar to or the same as the fluid valve control system 228 in Figure 2A. The fluid valve control system may be configured to include power connections, telecommunications connections, and pneumatic connections to the base assembly 1804. The fourth modular maintenance thread 1802D includes a perimeter gasket or fluid gasket and a shielding component configured to engage with the base assembly 1804.

[0311] In at least one exemplary embodiment, the fifth thread 1802E includes a bottle tray load cell assembly. The bottle tray load cell assembly may be similar to or identical to the load cell assembly 1500 in Figures 15A to 15M. The bottle tray load cell assembly may be configured to have power and signal connections to the base assembly 1804. The fifth modular maintenance thread 1802E includes a perimeter gasket or fluid gasket and a shielding component configured to engage with the base assembly 1804.

[0312] In at least one exemplary embodiment, the sixth thread 1802F includes a user interface device or screen. The user interface device may be configured to have power connections and signal connections to the base assembly 1804. The sixth modular maintenance thread 1802F includes a perimeter gasket or fluid gasket and a shielding component configured to engage with the base assembly 1804.

[0313] In at least ...

Claims

1. an apheresis system, said apheresis system, A chamber configured to receive a centrifuge assembly, A movable loop holder is positioned within the chamber, Equipped with, The movable loop holder comprises a loop holder body having a loop connection portion configured to interact with the flexible loop received by the centrifugal assembly, The movable loop holder is configured to move linearly between a first position and a second position. In the first position, the moving loop holder is at a first distance from the centrifuge assembly and is exposed in the chamber for a first length. In the second position, the moving loop holder is at a second distance from the centrifuge assembly and is exposed in the chamber for a second length. The second distance is greater than the first distance, and the first length is greater than the second length. Apheresis system.

2. In the apheresis system according to claim 1, The aforementioned centrifugal separator assembly comprises a first part and a second part, The second part is movable between an open position and a closed position relative to the first part. When the movable loop holder is in the first position, the second part of the centrifuge assembly is prevented from moving from the closed position to the open position. When the movable loop holder is in the second position, the second portion of the centrifuge assembly can move from the closed position to the open position. Apheresis system.

3. In the apheresis system according to claim 2, In the second position, a clearance exists between the moving loop holder and the centrifuge assembly, allowing the second portion to move between the open position and the closed position. Apheresis system.

4. In the apheresis system according to claim 3, The second part is connected to the first part via a hinge, and the trajectory of the movement of the second part between the open position and the closed position is in the shape of an arc. Apheresis system.

5. In the apheresis system according to claim 1, The housing defining the chamber has a first side and a second side. The first side and the second side are parts of the housing that are opposite to each other. In the first position, the movable loop holder is closer to the first side of the housing than when it is in the second position. In the second position, the movable loop holder is closer to the second side of the housing than it is in the first position. Apheresis system.

6. In the apheresis system according to claim 1, The loop connection portion includes a connector lock portion configured to engage with the connector of the flexible loop, The connector is a connector for connecting to the connector locking portion. Apheresis system.

7. In the apheresis system according to claim 6, The connector locking portion comprises a flange and a connector locking wheel. The flange and the connector lock wheel are provided at positions spaced apart from each other in the insertion direction of the flexible loop in the connector lock portion. The connector locking portion is configured such that the connector locking wheel moves relative to the flange, thereby applying holding pressure to the connector of the flexible loop. Apheresis system.

8. In the apheresis system according to claim 7, In the first position, the flexible loop is locked to the loop holder body in a position between the flange and the connector lock wheel. Apheresis system.

9. an apheresis system, said apheresis system, Chamber and, A centrifuge assembly disposed within the chamber and comprising a lower housing portion and an upper housing portion, wherein the upper housing portion is movable relative to the lower housing portion, The chamber comprises a movable loop holder positioned within the chamber, The movable loop holder comprises a loop holder body and a loop connecting portion located at the end of the loop holder body. The loop connection portion is configured to interact with the flexible loop extending from the centrifuge assembly. The aforementioned movable loop holder is configured to move linearly between an extended position and a retracted position. In the extended position, the movable loop holder is at a first distance from the centrifuge assembly and is exposed within the chamber for a first length, preventing the upper housing portion from moving relative to the lower housing portion. In the retracted position, the movable loop holder is at a second distance from the centrifuge assembly and is exposed into the chamber for a second length, and the upper housing portion is able to move relative to the lower housing portion. The first length is greater than the second length. Apheresis system.

10. In the apheresis system according to claim 9, In the retracted position, a clearance exists between the movable loop holder and the centrifuge assembly, allowing the upper housing portion to move between the open and closed positions relative to the lower housing portion. Apheresis system.

11. In the apheresis system according to claim 10, The upper housing portion is connected to the lower housing portion via a hinge, and the movement trajectory of the upper housing portion between the open position and the closed position is in the shape of an arc. Apheresis system.

12. In the apheresis system according to claim 9, The housing defining the chamber has a first side and a second side. The first side and the second side are parts of the housing that are opposite to each other. In the extended position, the movable loop holder is closer to the first side of the housing than when it is in the retracted position. In the retracted position, the movable loop holder is closer to the second side of the housing than when it is in the extended position. Apheresis system.

13. In the apheresis system according to claim 9, The loop connection portion includes a connector lock portion configured to engage with the connector of the flexible loop, The connector is a connector for connecting to the connector locking portion. Apheresis system.

14. In the apheresis system according to claim 13, The connector locking portion comprises a flange and a connector locking wheel. The flange and the connector lock wheel are provided at positions spaced apart from each other in the insertion direction of the flexible loop in the connector lock portion. The connector locking portion is configured such that the connector locking wheel moves relative to the flange, thereby applying holding pressure to the connector of the flexible loop. Apheresis system.

15. In the apheresis system according to claim 9, The loop connection portion includes a connector lock portion configured to engage with the connector of the flexible loop, The connector is a connector for connecting to the connector locking portion. The connector locking portion comprises a flange and a connector locking wheel. The flange and the connector lock wheel are provided at positions spaced apart from each other in the insertion direction of the flexible loop in the connector lock portion. In the extended position, the flexible loop is locked relative to the loop holder body in a position between the flange and the connector lock wheel. Apheresis system.

16. A method for installing a centrifugal filler into an apheresis system, the method being: A step of moving a movable loop holder, which is located in a centrifuge chamber, linearly from an extended position to a retracted position, wherein a centrifuge assembly is also located in the centrifuge chamber, and the movable loop holder comprises a loop holder body and a loop connecting portion located at the end of the loop holder body, the loop connecting portion being configured to interact with a flexible loop extending from the centrifuge assembly, and in the extended position, the movable loop holder is at a first distance from the centrifuge assembly and exposed in the chamber by a first length, and in the retracted position, the movable loop holder is at a second distance from the centrifuge assembly and exposed in the chamber by a second length, the second distance being greater than the first distance, and the first length being greater than the second length, and the step of moving the movable loop holder, which is located in a centrifuge chamber, from an extended position to a retracted position. A step of moving the upper housing portion of the centrifuge assembly from a closed position to an open position relative to the lower housing portion, wherein in the retracted position, there is a clearance between the moving loop holder and the centrifuge assembly, allowing the upper housing portion to move between the open position and the closed position. The steps include bringing the collection bladder, which includes the flexible loop, into contact with the exposed portion of the centrifuge chamber, The steps include moving the upper housing portion from the open position to the closed position to accommodate at least a portion of the collection bladder, The steps include: moving the movable loop holder linearly from the retracted position to the extended position; Having, How to install a centrifugal filler into an apheresis system.

17. In the method according to claim 16, The movable loop holder further comprises a release latch, which, when operated, moves the movable loop holder from the extended position to the retracted position, or from the retracted position to the extended position. method.

18. In the method according to claim 16, The upper housing portion is connected to the lower housing portion via a hinge, and the movement trajectory of the upper housing portion between the open position and the closed position is in the shape of an arc. method.

19. In the method according to claim 16, The housing defining the centrifugal separator chamber has a first side and a second side. The first side and the second side are parts of the housing that are opposite to each other. In the extended position, the movable loop holder is closer to the first side of the housing than when it is in the retracted position. In the retracted position, the movable loop holder is closer to the second side of the housing than when it is in the extended position. method.

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