RU2807435C2 - Methods and systems for high capacity collection of blood components - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: method for collecting blood component by apheresis includes: pumping whole blood into a centrifuge from a donor, introducing whole blood into a blood component collection reservoir having an inlet and an outlet, wherein the whole blood is introduced through the inlet, rotating the centrifuge to provide centrifugal force to act on the whole blood to separating the whole blood in the blood component collection reservoir into at least plasma and a blood component containing concentrated red blood cells, separating the plasma from the whole blood, extracting the plasma through the outlet of the blood component collection reservoir into a container, detecting when the red blood cells are extracted through the outlet and, upon detection of red blood cells and while the centrifuge continues to rotate, expelling the plasma back into the blood component collection reservoir through the outlet to move the red blood cells through the inlet and out of the blood component collection reservoir. An apheresis system, embodiments of a centrifuge assembly, a method for automatically loading a fluid line circuit into a centrifuge assembly, embodiments of a device for separating blood components, a blood component collection circuit, a blood component collection cassette for use with a centrifuge, a blood component collection kit, and a method for moving fluid substances through a blood component collection cassette for use with a centrifuge are disclosed.

EFFECT: reduction of time and increase of comfort during use.

88 cl, 63 dwg

Description

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] According to this application, 35 U.S.C. § 119(e), claims the effect and priority of U.S. Provisional Applications Serial Nos. 62/488,404, filed April 21, 2017, entitled “Disposable Loading,” and 62/539,053, filed July 31, 2017, entitled “Component Collection.” The entire disclosures of the applications listed above are hereby incorporated by reference in their entirety in their entirety and for all purposes.

REGION

[0002] The present disclosure is generally directed to separating components from multicomponent fluids, particularly for apheresis methods and systems.

BACKGROUND

[0003] There are two common methods for donating/collecting blood. The first is the donation of whole blood by a donor, followed by a centrifugal process that separates blood components from the whole blood based on the density of the blood component. The desired component can be manually, semi-automatically or automatically transferred into the collection vessel during, or possibly after, the whole blood is exposed to the forces generated by the centrifuge. Another method may be apheresis collection, which requires a specialized machine.

[0004] By apheresis, whole blood is extracted from a donor while the donor is connected to a specialized machine. Whole blood can be centrifuged again to collect only the blood component (eg plasma) that is desired, and all other unwanted blood components can be returned back to the donor during the same donation. The donor is connected to an apheresis machine during separation and collection of the blood component. Unfortunately, the apheresis process can be lengthy and uncomfortable. Often the donor must remain connected to the machine for an hour to complete the donation of the blood component. Thus, there is a need to make the donation process at apheresis collection sites more efficient.

SUMMARY

[0005] There is a need for a system for plasma or other blood components that can reduce donation time and increase donor comfort. The embodiments presented herein allow for increased efficiency of the donation process by using the separated blood component to push or propel unwanted blood components back toward the donor without stopping and restarting the centrifuge. Thus, the embodiments herein make the donation process more efficient and faster for the donor.

[0006] Embodiments may also provide methods and apparatus for arranging parts, such as circuits, of disposable agents in medical devices. Embodiments may include the use of surfaces to automatically guide contours. In some embodiments, the medical devices may be blood separation machines, such as apheresis machines.

[0007] The previously stated and other needs are addressed by various aspects, embodiments and/or configurations of the present disclosure. Also, although the disclosure is presented in terms of exemplary embodiments, it should be appreciated that individual aspects of the disclosure may be stated separately.

[0008] Embodiments include an assembly for separating a component from a multicomponent fluid, the assembly comprising: a filler containing a channel for housing a disposable agent separation reservoir, where the channel comprises two opposing walls; and a contour angular guide comprising a plurality of bearings, the contour angular guide supporting the flexible contour of the disposable agent when the separation reservoir is loaded into the channel.

[0009] Aspects of the above assembly include embodiments where the contour angular position guide includes a locking plate. Aspects of the above assembly include embodiments where the flexible loop contacts the locking plate when positioned in the loop angular position guide. Aspects of the above assembly include variations where the assembly is part of an apheresis machine. Aspects of the above assembly include variations where the assembly is coupled to a rotor that rotates a loop angular position guide about an axis of rotation. Aspects of the above assembly include embodiments wherein the plurality of bearings comprises a plurality of pairs of roller bearings.

[0010] Embodiments include a centrifuge assembly that includes: a centrifuge body having an outer surface and an internal cavity where the centrifuge body is rotated about a rotation axis of the centrifuge assembly; a fluid separation element located at least partially in the internal cavity of the centrifuge body and configured to rotate relative to the centrifuge body around an axis of rotation; and a fluid line loop bracket attached to a portion of the centrifuge body and extending along the length of an outer surface of the centrifuge body, the fluid line loop bracket includes a set of bearings located at a point along the length of the outer surface where the set of bearings is configured to contact a tubular portion of the associated loop the fluid line and maintain the fluid line contour in an engaged position relative to the centrifuge body while allowing the fluid line contour to rotate in the engaged position.

[0011] Aspects of the above centrifuge assembly include embodiments where the bearing set includes a pair of roller bearings. Aspects of the above centrifuge assembly include variations wherein the bearing set comprises a plurality of pairs of roller bearings. Aspects of the above centrifuge assembly include variations wherein the centrifuge assembly is part of an apheresis machine. Aspects of the above centrifuge assembly include wherein the fluid line loop is attached to a static non-rotating portion of the apheresis machine at a first end of the fluid line loop through a first rigid connection connector, and where the fluid line loop is coupled to a fluid separating element in an internal cavity at a second end of the line loop fluid through the second rigid connector. Aspects of the above centrifuge assembly include embodiments where the second end of the fluid line loop is rotated with the fluid separating element. Aspects of the above centrifuge assembly include embodiments where the fluid line loop is physically attached to and fluidly coupled to the disposable fluid separation reservoir at the second rigid connection connector. Aspects of the above centrifuge assembly include that the fluid line contour contains a plurality of openings and that the fluid separation reservoir contains a first flexible sheet attached to a second flexible sheet, forming a fluid path where the first portion of the fluid path is narrow compared to the second portion fluid paths.

[0012] Embodiments include a method for automatically loading a fluid line loop into a centrifuge assembly, the method including: attaching the fluid line loop at a first end to a fluid separation member of the centrifuge assembly; and rotating the fluid separating element in a first rotational direction relative to the housing of the centrifuge assembly, wherein rotation of the fluid separating element causes rotation of the fluid line contour relative to the housing and the guide into the channel of the circuit bracket that is attached to the portion of the housing, where the channel contains bearings disposed in the set bearings attached to the circuit bracket, where the bearings hold the fluid line circuit in position relative to the housing as the centrifuge assembly rotates.

[0013] Aspects of the above method include embodiments where the bearings contact a portion of the fluid line contour as the fluid line contour rotates within the channel at a predetermined position relative to the housing. Aspects of the above method include embodiments where the centrifuge body is rotated in a first rotational direction at a first angular velocity about the axis of rotation and causes the fluid separating element to rotate at a different second angular velocity about the axis of rotation through a torsional force provided by the fluid line contour. Aspects of the above method include wherein the second angular velocity is substantially twice the first angular velocity. Aspects of the above method include wherein the fluid line contour is physically and fluidically attached to a disposable fluid separation reservoir that is located at least partially within the fluid separation element. Aspects of the above method further include: attaching the second end of the fluid line loop to a rotationally fixed point on the apheresis machine; and rotating, through the rotor and motor assembly of the apheresis machine, the centrifuge assembly about an axis of rotation relative to a rotationally fixed point of the apheresis machine.

[0014] Embodiments include a method of collecting a blood component through apheresis, the method including: aspirating whole blood into a centrifuge from a donor; rotating the centrifuge to cause centrifugal force to be applied to the whole blood to separate the whole blood into at least a first blood component and a third blood component; separating the first blood component from the whole blood; removing the first blood component into a container; detecting when the second blood component is removed; and upon detecting the second blood component and while the centrifuge continues to rotate, pushing the separated first blood component back toward the centrifuge to move at least the third blood component out of the centrifuge and back into the donor.

[0015] Aspects of the above method include variations wherein the first blood component is one or more of plasma, platelets, red blood cells, and/or high hematocrit blood. Aspects of the above method include wherein the second blood component is one or more of plasma, platelets, red blood cells and/or high hematocrit blood and the third blood component is one or more of plasma, platelets, red blood cells and/or blood with high hematocrit. Aspects of the above method include variations wherein the first blood component is two or more of plasma, platelets, red blood cells, and/or high hematocrit blood. Aspects of the above method include embodiments where the centrifuge is rotated at a first speed while separating the first blood component from the whole blood. Aspects of the above method include embodiments where the centrifuge continues to rotate at a first speed while the separated first blood component is pushed back toward the centrifuge. Aspects of the above method include variations where the centrifuge is rotated at a second speed while drawing whole blood into the centrifuge from a donor. Aspects of the above method include variations wherein the second speed is lower than the first speed. Aspects of the above method include embodiments where the first blood component is separated from the whole blood in a blood component collection kit that is inserted into a centrifuge. Aspects of the above method include embodiments where the centrifuge includes a filler that rotates a blood component collection reservoir associated with a blood component collection kit. Aspects of the above method include embodiments where a blood component collection reservoir is inserted into a collection insert channel formed in the core to receive the blood component collection reservoir.

[0016] Embodiments include an apheresis system that includes: a first tube having a lumen in fluid communication with a needle that moves whole blood from a donor through the lumen; a suction pump in engagement with the first tube that draws whole blood into the centrifuge from the donor; a centrifuge that is rotated to generate a centrifugal force to act on the whole blood to separate the whole blood into at least a first blood component and a third blood component; a blood component collection reservoir inserted into the centrifuge and in fluid communication with the first tube that separates the first blood component from the whole blood; a second tube in fluid communication with the blood collection reservoir that moves the first blood component from the blood component collection reservoir; a collection container in fluid communication with a second tube that removes the first blood component from the apheresis system; a sensor located in physical proximity to the second tube for detecting when the second blood component is withdrawn from the whole blood; and upon detection of the second blood component by the sensor and while the centrifuge continues to rotate, a return pump coupled to the second tube that pushes the separated first blood component back to the blood component collection reservoir through the second tube to move the at least third blood component from reservoir for collecting blood components and back to the donor.

[0017] Aspects of the above apheresis system include variations wherein the first blood component is plasma and the second blood component is platelets, red blood cells, and/or high hematocrit blood. Aspects of the above apheresis system further include an anticoagulant pump for drawing anticoagulant from the anticoagulant bag and mixing the anticoagulant with whole blood in a manifold or joint in fluid communication with the first tube. Aspects of the above apheresis system include variations where the centrifuge contains a filler that rotates a reservoir to collect blood components. Aspects of the above apheresis system include embodiments where a blood component collection reservoir is inserted into a collection insert channel formed in the core to accommodate the blood component collection reservoir.

[0018] Embodiments include a blood component collection kit associated with an apheresis system, which includes: a needle inserted into a donor blood vessel to aspirate whole blood from the donor; a first tube having a lumen in fluid communication with a needle that moves whole blood through the lumen, where a suction pump coupled to the first tube draws whole blood from the donor; a blood component collection reservoir inserted into the centrifuge and in fluid communication with the first tube that separates the first blood component and the third component from the whole blood; a second tube in fluid communication with the blood collection reservoir that moves the first blood component from the blood component collection reservoir; and a collection container in fluid communication with a second tube that extracts a first blood component from the apheresis system, where a sensor is positioned in physical proximity to the second tube to detect when a second blood component is withdrawn from the whole blood; and where after detecting the second blood component by the sensor and while the centrifuge continues to rotate, a return pump coupled to the second tube pushes the separated first blood component back to the blood component collection reservoir through the second tube to move the at least third blood component from reservoir for collecting blood components and back to the donor.

[0019] Aspects of the above blood component collection kit include embodiments wherein the first blood component is plasma and the second blood component is platelets. Aspects of the foregoing blood component collection kit include embodiments wherein the suction pump is disengaged as the return pump pushes the separated first blood component back toward the blood component collection reservoir through a second tube to move at least a third blood component out of the collection reservoir blood components and back to the donor. Aspects of the above blood component collection kit include embodiments where the blood component collection reservoir is inserted into and held in a fill, in a centrifuge that rotates the blood component collection reservoir. Aspects of the above blood component collection kit include embodiments where a blood component collection reservoir is inserted into a collection insert channel formed in the core to receive the blood component collection reservoir.

[0020] Embodiments include a filler for housing a separation tank in which a component is separated from a multicomponent fluid, the filler comprising: a channel for receiving a separation tank during separation of a component from a multicomponent fluid, the channel includes: a first wall; and a second wall opposite the first wall; and wherein the first end of the channel is adjacent to the central portion of the core and the channel spirals toward an outer perimeter of the core.

[0021] Aspects of the above filler include variations where the top portion of the channel is narrower than the middle portion of the channel. Aspects of the above core include embodiments wherein at least a portion of the second wall has a concave surface. Aspects of the above filler include embodiments where the second end of the channel is positioned to experience a greater gravitational force during separation than the first end. Aspects of the above filler include options where the top of the channel provides reinforcement to the separation tank during separation.

[0022] Embodiments include a fluid separation filler that comprises: a housing having an axis of rotation substantially located at the center of mass of the housing; and a fluid collection insert channel located in the housing and extending in a substantially helical path extending from a first point adjacent the axis of rotation spirally outward to a second point adjacent the periphery of the housing, where the fluid collection insert channel projects outwardly toward the periphery the housing near the end of the substantially helical path, forming the third point of the fluid collection insert channel furthest from the axis of rotation.

[0023] Aspects of the above fluid separation core further include: a fluid collection chamber located in the housing and following a portion of a substantially helical path, wherein a fluid collection insert channel is coupled to the fluid collection chamber, defining an access area between the interior fluid collection chambers and the outer part of the housing. Aspects of the above fluid separation fill include embodiments wherein the fluid collection chamber is configured to receive a disposable fluid collection reservoir. Aspects of the above fluid separation aggregate include embodiments wherein the distance from the axis of rotation to the third point of the substantially helical path is greater than the distance from the axis of rotation to the second point of the substantially helical path. Aspects of the above fluid separation core include embodiments wherein the width of the fluid collection chamber at a point along the substantially helical path is greater than the width of the fluid collection insert channel at a point along the generally helical path. Aspects of the foregoing fluid separation core include embodiments wherein the fluid collection chamber further comprises a first wall extending along the innermost portion of the substantially helical path and a second wall substantially parallel to the first wall and extending along the outermost portion of the substantially helical path. Aspects of the foregoing fluid separation core include embodiments wherein the fluid collection chamber further comprises one or more beveled walls positioned between the first wall and the second wall, and wherein the one or more beveled walls are configured to guide the disposable fluid collection reservoir to a position landing in the fluid collection chamber. Aspects of the above fluid separation filler include embodiments wherein the fluid inlet for the disposable fluid collection reservoir, when installed in the fluid collection chamber, is positioned adjacent to the axis of rotation, and the first fluid path in the disposable fluid collection reservoir follows essentially in a spiral path outward to the end of the disposable fluid collection reservoir located adjacent at the third point of the fluid collection insert channel farthest from the axis of rotation, and is fluidly connected to a second fluid path separated from the first fluid path , in a disposable fluid collection reservoir that extends in a direction from the third point, following a substantially spiral path inward toward a fluid outlet for the disposable fluid collection reservoir located adjacent the axis of rotation. Aspects of the foregoing fluid separator include embodiments wherein the fluid inlet and fluid outlet are part of a connector attached to a disposable fluid collection reservoir, and wherein the body of the fluid separator includes a connection point that is engaged with the connector . Aspects of the above fluid separation core include embodiments wherein the connector includes at least one protruding element, where the connecting point includes at least one mating protruding element, and where the protruding elements rigidly connect the connector relative to the connecting point.

[0024] Embodiments include a centrifuge assembly that includes: a centrifuge body having an internal cavity where the centrifuge body is rotated about a rotation axis of the centrifuge assembly; and a fluid separation element located at least partially in the internal cavity of the centrifuge body and configured to rotate relative to the centrifuge body about an axis of rotation, where the fluid separation element includes a fluid collection insert channel located in the fluid separation element next in line a substantially helical path extending from a first point adjacent to the axis of rotation in a helical outward manner to a second point located adjacent the periphery of the fluid separating element, wherein the channel of the fluid collection insert projects outwardly toward the periphery of the element near the end of the substantially helical path, forming a third the point of the fluid collection insertion channel furthest from the axis of rotation.

[0025] Aspects of the above centrifuge assembly include embodiments wherein the fluid separation element further comprises a fluid collection chamber disposed in the element and subsequent portions of a substantially helical path where a fluid collection insert channel is coupled to the fluid collection chamber to form an access area between the interior of the fluid collection chamber and the exterior of the fluid separation element. Aspects of the above centrifuge assembly further include a disposable fluid collection reservoir disposed in a fluid collection chamber following a substantially helical path, where the disposable fluid collection reservoir includes a fluid inlet adjacent the axis of rotation and a first fluid path in the disposable fluid collection reservoir follows a substantially spiral path outward to the end of the disposable fluid collection reservoir located adjacent the third point of the fluid collection insert channel furthest from the axis of rotation, and is fluidly coupled to the second path fluid separated from the first fluid path in a disposable fluid collection reservoir that extends in a direction from a third point, following a substantially helical path, inward to a fluid outlet for a disposable fluid collection reservoir located adjacent to the axis rotation. Aspects of the above centrifuge assembly include variations wherein the centrifuge assembly is part of an apheresis machine. Aspects of the above centrifuge assembly include embodiments where the centrifuge body is divided into an upper body and a lower body, where the upper body contains an internal cavity, where the upper body can be rotated between an open state and a closed state about a rotation axis that is offset and substantially perpendicular to the rotation axis, and where the fluid collection insertion channel of the fluid separation element is accessible in the open state and inaccessible in the closed state.

[0026] Embodiments include a blood component collection circuit that includes: a flexible circuit; a system static loop connector located at the first end of the flexible loop, where the system static loop connector is connected to the fixed loop connection of the centrifuge to fix the first end of the flexible loop for rotation with the centrifuge; a core contour connector disposed at a second end opposite the first end of the flexible circuit, where the core circuit connector is connected to a core circuit connecting area and where torsional forces based on torsion in the flexible circuit are imparted to the core through the core circuit connector; and wherein the flexible circuit is rotated to be grasped by a circuit angular position guide located on the centrifuge.

[0027] Aspects of the above blood component collection circuit include embodiments wherein the blood component collection circuit is part of a blood component collection kit and wherein the blood component collection kit is associated with an apheresis system. Aspects of the above blood component collection circuit include embodiments where the circuit angular position guide is attached to a rotor that rotates the circuit angular position guide and the flexible circuit about an axis of rotation. Aspects of the foregoing blood component collection circuit include embodiments wherein the blood component collection circuit is at least partially positioned by a circuit position locking plate. Aspects of the above blood component collection circuit include variations where the flexible circuit is bent around a centrifuge. Aspects of the above blood component collection circuit include embodiments where the flexible circuits are also held in position by a circuit holding bracket. Aspects of the foregoing blood component collection circuit include embodiments wherein at least a portion of the circuit's angular position guide comprises a circuit torsion support bearing. Aspects of the above blood component collection circuit include embodiments wherein the circuit's torsion support bearing comprises a pair of roller bearings. Aspects of the above blood component collection circuit include embodiments where the circuit torsion support bearing allows torsion of the flexible circuit. Aspects of the above blood component collection circuit include variations where torsion causes the media to rotate at a higher angular velocity than a centrifuge. Aspects of the foregoing blood component collection circuit include embodiments wherein the flexible circuit may comprise two or more lumens in order to move whole blood and/or blood components within the flexible circuit.

[0028] Embodiments include a flexible circuit loading assembly, the assembly comprising: a circuit rotation position guide comprising a channel for receiving the flexible circuit of a blood component collection kit; a loop torsion support bearing disposed in the channel and on the loop rotation position guide portion to support the flexible loop; and a loop grip lever, wherein the loop grip lever is positioned adjacent to the channel and coupled to the loop rotation position guide to guide the flexible loop into the channel and into contact with the loop torsion support bearing.

[0029] Aspects of the above assembly include embodiments where the assembly is part of an apheresis machine and where the loop rotation position guide is attached to a centrifuge that rotates the loop rotation position guide and the flexible circuit about an axis of rotation. Aspects of the above assembly include embodiments where the loop rotation position guide further comprises a loop position stop plate to further position the flexible loop. Aspects of the above assembly further include a loop holding bracket positioned in plane with the loop rotation position guide and positioned on the centrifuge to further grip the flexible loop.

[0030] Embodiments include a method for automatically loading a flexible circuit into an assembly, the method including: connecting a system static circuit connector located at a first end of the flexible circuit to a fixed centrifuge circuit connection to lock the first end of the flexible circuit for rotation with the centrifuge; connecting a core contour connector disposed at a second end opposite the first end of the flexible circuit to a core circuit connecting area, and wherein torsional forces based on torsion in the flexible circuit are imparted to the core through the core circuit connector; and rotary movement of the flexible circuit into the guide of the angular position of the circuit, located on the centrifuge.

[0031] Aspects of the above method include embodiments where the flexible loop engages a loop torsion support bearing housed in a channel formed by the loop rotation position guide, where the loop torsion support bearing carries the flexible loop. Aspects of the above method include embodiments where the loop gripping arm engages the flexible loop in rotation to guide the flexible loop into the channel and into contact with the loop's torsion support bearing. Aspects of the above method include embodiments where the loop rotation position guide further comprises a loop position stop plate to prevent excessive rotation of the flexible loop outside the channel. Aspects of the above method include embodiments where a loop holding bracket positioned in plane with the loop rotation position guide and positioned on the centrifuge further grips and holds the flexible loop.

[0032] Embodiments include a soft cassette comprising: a first cassette port; second cassette port; a direct-flow lumen fluidly connected to the first port of the cassette and the second port of the cassette; a drip chamber placed in the co-flow lumen such that fluid passing through the co-flow lumen passes through the drip chamber; and a bypass fluid flow path, both fluidly connected to a co-flow lumen adjacent to the first cassette port and between the first cassette port and the drip chamber, and fluidly connected to a co-flow lumen adjacent to the second cassette port and between the second cassette port and the drip chamber chamber such that fluid flowing through the fluid flow bypass path bypasses the drip chamber.

[0033] Aspects of the foregoing soft cassette include embodiments wherein the fluid flow bypass path consists of a first bypass branch fluidly connected to a co-flow lumen adjacent the first port of the cassette, and a second bypass branch fluidly coupled to a co-flow lumen adjacent to the second cassette port. Aspects of the above soft cassette include embodiments wherein the fluid flow bypass path further comprises a fluid pressure ring positioned between and fluidly coupled to the first bypass branch and the second bypass branch. Aspects of the above soft cassette include embodiments wherein the co-flow lumen includes a first elastic region positioned between the first connection to the first bypass leg and the drip chamber that allows the first fluid control valve to close the co-flow lumen. Aspects of the foregoing soft cassette include embodiments wherein the co-flow lumen comprises a second elastic region positioned between a second connection to the second bypass leg and a drip chamber that allows the second fluid control valve to close the co-flow lumen. Aspects of the above soft cassette include embodiments wherein the flow lumen includes a third elastic region disposed in the first bypass leg that allows the fluid control outlet valve to occlude the first bypass leg. Aspects of the above soft cassette include embodiments where the first port of the cassette is in fluid connection to a cassette inlet tube that moves fluid from a donor to the soft cassette or fluid from the soft cassette to the donor and where the second port of the cassette is in fluid connection to a circuit inlet tube which moves fluid from the soft cassette to the centrifuge or fluid from the centrifuge to the soft cassette. Aspects of the above soft cassette include embodiments wherein, upon drawing fluid from a donor, the fluid passes through a fluid flow bypass path. Aspects of the above soft cassette include options where, when sending fluid to a donor, the fluid passes through a co-flow lumen. Aspects of the above soft cassette include embodiments wherein, when fluid is sucked from the donor in a subsequent suction, a portion of the fluid that was previously sent to the donor through the once-through lumen is retained in the drip chamber as the fluid passes through the bypass fluid flow path. Aspects of the above soft cassette include embodiments where the soft cassette is part of a blood component collection kit. Aspects of the above soft cassette include embodiments where the blood component collection kit is part of the apheresis system.

[0034] Embodiments include a blood component collection kit, the blood component collection kit comprising: a centrifuge for separating blood components from whole blood; a cassette inlet tube fluidly connected to the donor; a circuit inlet tube fluidly connected to the centrifuge; a soft cassette comprising: a first cassette port in fluid communication with a cassette inlet tube; a second cassette port in fluid communication with the circuit inlet tube; a direct-flow lumen fluidly connected to the first port of the cassette and the second port of the cassette; a drip chamber placed in the direct-flow lumen such that fluid passing through the direct-flow lumen passes through the drip chamber; and a bypass fluid flow path, both fluidly connected to a co-flow lumen adjacent to the first cassette port and between the first cassette port and the drip chamber, and fluidly connected to a co-flow lumen adjacent to the second cassette port and between the second cassette port and the drip chamber chamber such that fluid flowing through the fluid flow bypass path bypasses the drip chamber.

[0035] Aspects of the above blood component collection kit include embodiments wherein the fluid flow bypass path comprises: a first bypass branch fluidly coupled to a flow lumen adjacent the first cassette port; a second bypass branch fluidly connected to a direct-flow lumen adjacent to the second port of the cassette; and a fluid pressure ring disposed between and fluidly connected to the first bypass branch and the second bypass branch. Aspects of the foregoing blood component collection kit include embodiments wherein the co-flow lumen comprises a first elastic region disposed between a first connection to the first bypass leg and a drip chamber that allows a first fluid control valve to occlude the co-flow lumen, wherein the co-flow lumen includes a second elastic region disposed between the second connection to the second bypass leg and the drip chamber, which allows the second fluid control valve to close the flow lumen, and where the once-through lumen includes a third elastic region located in the first bypass leg, which allows the outlet fluid control valve to close the first bypass branch. Aspects of the above blood component collection kit include wherein, upon aspiration of fluid from a donor: the first fluid control valve and the second fluid flow control valve close and block the direct flow lumen; and the fluid control outlet valve is opened and allows whole blood to pass through the bypass fluid flow path. Aspects of the above blood component collection kit include where, when sending fluid to a donor: the first fluid control valve and the second fluid flow control valve are opened and allow the fluid to pass through the co-flow lumen; and the fluid control outlet valve closes and blocks the bypass path of fluid flow. Aspects of the foregoing blood component collection kit include embodiments wherein, upon aspiration of fluid from a donor in a subsequent suction, a portion of the fluid that was previously sent to the donor through the through-flow lumen is retained in the drip chamber as the fluid passes through a bypass fluid flow path.

[0036] Embodiments include a method of moving fluids through a soft cassette, comprising: providing a soft cassette, the soft cassette comprising: a first cassette port in fluid communication with a cassette inlet tube; a second cassette port in fluid communication with the circuit inlet tube; a direct-flow lumen fluidly connected to the first port of the cassette and the second port of the cassette; a drip chamber placed in the co-flow lumen such that fluid passing through the co-flow lumen passes through the drip chamber; and a bypass fluid flow path, both fluidly connected to a co-flow lumen adjacent to the first cassette port and between the first cassette port and the drip chamber, and fluidly connected to a co-flow lumen adjacent to the second cassette port and between the second cassette port and the drip chamber a chamber such that fluid flowing through the fluid flow bypass path bypasses the drip chamber; when absorbing whole blood from a donor: receiving whole blood from a cassette inlet tube at a first port of the cassette in fluid communication with the cassette inlet tube; moving whole blood through the fluid flow bypass path into a second port of the cassette; preventing the movement of whole blood through the direct lumen; when returning red blood cells to the donor: receiving red blood cells from the circuit inlet tube at a second cassette port fluidly connected to the circuit inlet tube; moving red blood cells through the direct-flow lumen and drip chamber into the first port of the cassette; and preventing red blood cells from moving through the fluid flow bypass.

[0037] Aspects of the above method include variations wherein, when the fluid is sucked from the donor in a subsequent suction, a portion of the fluid that was previously sent to the donor through the direct flow lumen when the red blood cells are returned to the donor is retained in the drip chamber when the whole blood is again passed through through a fluid flow bypass.

[0038] Any one or more aspects/embodiments are substantially disclosed herein.

[0039] Any one or more aspects/embodiments are substantially disclosed herein. optionally in combination with any one or more other aspects/embodiments as substantially disclosed herein.

[0040] One or more means adapted to implement any one or more of the above aspects/embodiments are essentially disclosed herein.

[0041] The present disclosure may provide a variety of advantages depending on the particular aspect, embodiment, and/or configuration. By maintaining the rotation speed of the centrifuge while moving unwanted blood components back to the donor, the apheresis procedure can be reduced in time, perhaps by 30% or more. This increase in efficiency allows for faster and more comfortable checkout. With shorter turnaround times, the dropoff center can receive more change in a typical day, increasing productivity and revenue. Additionally, donors are more likely to return to donate again if donation occurs more quickly. Having faster surrender rates may also allow surrender centers to attract donors using other surrender centers with slower surrender rates.

[0042] These and other advantages will be apparent from the disclosure.

[0043] The phrases “at least one,” “one or more,” and “and/or” are open-ended expressions that are both conjunctive and disjunctive in action. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B or C”, “one or more of A, B and C”, “one or more of A, B or C" and "A, B and/or C" refer to A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together.

[0044] Object in the singular refers to one or more such objects. As such, the singular terms “one or more” and “at least one” may be used interchangeably herein. It should also be noted that the terms “comprises,” “includes,” and “has” can be used interchangeably.

[0045] The term “donor” as used herein can refer to any person who provides a fluid, such as whole blood, to an apheresis system. The donor may also be a patient who also provides fluid to the apheresis system temporarily while the fluid is processed, treated, manipulated, etc. before being provided back to the patient.

[0046] The term "automatic" and its variations, as used herein, refers to any process or operation performed without material human intervention when the process or operation is carried out. However, a process or operation may be automatic even though the process or operation involves tangible human involvement or intangible human involvement if the involvement occurs before the process or operation is performed. A person's participation is considered material if such participation influences how a process or operation is performed. Human participation, which relates to the efficiency of a process or operation, is not considered “material.”

[0047] The term “computer-readable medium” as used herein refers to any tangible storage and/or transmission medium that is involved in providing instructions to a processor for execution. Such media may also take many forms, including, but not limited to, non-volatile media, volatile media, and transmission media. Non-volatile media include, for example, NVRAM or magnetic or optical disks. Volatile media include dynamic memory such as main memory. Common forms of computer-readable media include, for example, floppy disk, floppy disk, hard disk, magnetic tape or any other magnetic medium, magnetic-optical medium, CD-ROM, any other optical medium, punched cards, paper tape, any other physical medium with hole patterns, RAM, PROM and EPROM, FLASH-EPROM, solid state media such as a memory card, any other memory chip or carrier wave cartridge as further disclosed herein, or any other media that a computer can read. A digital file attachment to an email or other single information archive or set of archives is considered a distributed medium equivalent to a tangible storage medium. When machine-readable environments are implemented in the form of a database, it should be understood that the database may be any type of database, such as relational, hierarchical, object-oriented, and/or the like. Accordingly, the disclosure is considered to include tangible storage media or distributed media and prior art equivalents and subsequent media in which implementations of the software of the present disclosure are stored.

[0048] The term "module" as used herein refers to any known or later developed hardware, software, firmware, artificial intelligence, fuzzy logic, or combination of hardware and software that is capable of implementing the functionality associated with this element.

[0049] The terms “determine,” “calculate,” and “calculate,” as well as variations thereof, as used herein, are used interchangeably and include a method, process, mathematical operation, or technique of any type.

[0050] It should be understood that the term "agent" as used herein is to be taken in its broadest possible interpretation in accordance with 35 U.S.C. Title 112, paragraph 6. Accordingly, a claim containing the term "agent" shall cover all structures, materials or activities set forth herein and all equivalents thereof. In addition, the structures, materials or actions, as well as their equivalents, must include all inventions described in substance, a brief description of the figures, a detailed description, an abstract and the claims themselves.

[0051] The above is a simplified summary of the disclosure to provide an understanding of certain aspects of the disclosure. This summary is neither a comprehensive nor an exhaustive overview of the disclosure and its various aspects, embodiments and/or configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure, but to present selected teachings of the disclosure in a simplified form as an introduction to the more detailed description that follows. It should be appreciated that other aspects, embodiments and/or configurations of the disclosure are possible using, alone or in combination, one or more of the features set forth above or described in detail below.

BRIEF DESCRIPTION OF THE FIGURES

[0052] In FIG. 1 is a perspective view of the operating environment of an apheresis system in accordance with embodiments of the present disclosure;

[0053] in FIG. 2A is a perspective view of the apheresis system shown in FIG. 1;

[0054] in FIG. 2B is a first detailed perspective view of an apheresis system pump in accordance with embodiments of the present disclosure;

[0055] in FIG. 2C is a second detailed perspective view of an apheresis system pump in accordance with embodiments of the present disclosure;

[0056] in FIG. 2D is a detailed perspective view of a fluid valve control system in accordance with embodiments of the present disclosure;

[0057] in FIG. 3A is a detailed perspective view of a disposable padded cassette assembly in accordance with embodiments of the present disclosure;

[0058] in FIG. 3B is a perspective view of a disposable soft cassette in accordance with embodiments of the present disclosure;

[0059] in FIG. 3C is a vertical sectional view taken through line 3C in FIG. 3B;

[0060] in FIG. 3D is a vertical sectional view taken through line 3D in FIG. 3B;

[0061] in FIG. 4A is a perspective view of a centrifuge assembly in an apheresis system in accordance with embodiments of the present disclosure;

[0062] in FIG. 4B is a front perspective view of the centrifuge assembly of FIG. 4A;

[0063] in FIG. 4C is a rear perspective view of the centrifuge assembly shown in FIG. 4A;

[0064] in FIG. 4D is a schematic cross-sectional view of a centrifuge assembly in a closed state in accordance with embodiments of the present disclosure;

[0065] in FIG. 4E is a schematic cross-sectional view of a centrifuge assembly in a partially open state in accordance with embodiments of the present disclosure;

[0066] in FIG. 4F is a schematic cross-sectional view of a centrifuge assembly in an open state in accordance with embodiments of the present disclosure;

[0067] in FIG. 4G is a perspective view of a centrifuge fill in accordance with embodiments of the present disclosure;

[0068] in FIG. 4H is a planar view of a centrifuge fill in accordance with embodiments of the present disclosure;

[0069] in FIG. 4I is a schematic planar view of a substantially helical fill receiving channel in accordance with embodiments of the present disclosure;

[0070] in FIG. 4J is a vertical sectional view taken through line 4J in FIG. 4H;

[0071] in FIG. 4K is a detailed cross-sectional view of a portion of a channel in a core in accordance with embodiments of the present disclosure;

[0072] in FIG. 4L illustrates various states of fluid collection reservoirs placed within the channel in the fill of FIG. 4K;

[0073] in FIG. 5A is a schematic view of a fluid component collection kit in accordance with embodiments of the present disclosure;

[0074] in FIG. 5B is an elevation view of a fluid component collection circuit in accordance with embodiments of the present disclosure;

[0075] in FIG. 5C is a cross-sectional view of a fluid component collection circuit reservoir in accordance with one embodiment of the present disclosure;

[0076] in FIG. 5D is a cross-sectional view of a fluid component collection circuit reservoir in accordance with another embodiment of the present disclosure;

[0077] in FIG. 5E is a perspective view of a fluid component collection circuit in a bent state in accordance with embodiments of the present disclosure;

[0078] in FIG. 5F is a perspective view of a fluid component collection circuit in a loading state in accordance with embodiments of the present disclosure;

[0079] in FIG. 5G is a perspective view of a fluid component collection circuit loaded into an aggregate in accordance with embodiments of the present disclosure;

[0080] in FIG. 5H is a perspective view of a fluid component collection circuit loaded into an aggregate in accordance with embodiments of the present disclosure;

[0081] in FIG. 6A is a schematic cross-sectional view of a centrifuge assembly in a first circuit loading state in accordance with embodiments of the present disclosure;

[0082] in FIG. 6B is a schematic cross-sectional view of a centrifuge assembly in a second circuit loading state in accordance with embodiments of the present disclosure;

[0083] in FIG. 6C is a schematic cross-sectional view of a centrifuge assembly in a third circuit loading state in accordance with embodiments of the present disclosure;

[0084] in FIG. 7A is a schematic plan view of a centrifuge assembly in a circuit loaded state in accordance with embodiments of the present disclosure;

[0085] in FIG. 7B is a schematic plan view of a centrifuge assembly in operation in accordance with embodiments of the present disclosure;

[0086] in FIG. 8 is a functional diagram of an embodiment of an apheresis system in accordance with embodiments of the present disclosure;

[0087] in FIG. 9 is a block diagram of an electrical system in an apheresis system in accordance with embodiments of the present disclosure;

[0088] in FIG. 10 is a further block diagram of an electrical system in an apheresis system in accordance with embodiments of the present disclosure;

[0089] in FIG. 11 is a further block diagram of an electrical system in an apheresis system in accordance with embodiments of the present disclosure;

[0090] in FIG. 12 is a process diagram of a method for performing apheresis in accordance with embodiments of the present disclosure;

[0091] in FIG. 13 is a process diagram of a method for performing apheresis in accordance with embodiments of the present disclosure;

[0092] In FIG. 14 is a process diagram of a method for performing apheresis in accordance with embodiments of the present disclosure;

[0093] in FIG. 15 is a process diagram of a method for performing apheresis in accordance with embodiments of the present disclosure;

[0094] in FIG. 16 is a process diagram of a method for inserting a disposable agent into an apheresis system fill in accordance with embodiments of the present disclosure;

[0095] in FIG. 17A is a functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0096] in FIG. 17B is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0097] in FIG. 17C is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0098] in FIG. 17D is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0099] in FIG. 17E is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0100] in FIG. 17F is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0101] in FIG. 17G is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0102] in FIG. 17H is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0103] in FIG. 17I is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0104] in FIG. 17J is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0105] in FIG. 17K is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0106] in FIG. 17L is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0107] in FIG. 17M is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0108] in FIG. 17N is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0109] in FIG. 17O is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0110] in FIG. 17P is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0111] in FIG. 17Q is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0112] in FIG. 17R is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure;

[0113] in FIG. 17S is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure; And

[0114] in FIG. 17T is another functional diagram of an apheresis system during an apheresis procedure in accordance with embodiments of the present disclosure.

[0115] In the accompanying drawings, similar components and/or features may have the same reference number. In addition, different components of the same type can be distinguished by the fact that the position number is followed by a letter that distinguishes similar components. If only the first item number is used in the description, the description can be applied to any one of the similar components having the same first item number, regardless of the second item number.

DETAILED DESCRIPTION

[0116] Embodiments of the present disclosure are described in connection with apheresis methods and systems. The following embodiments may be described with respect to separating blood components from whole blood. However, this sample procedure is provided merely for illustrative purposes. It should be noted that the embodiments are not limited to the following description. Embodiments are intended for use in products, processes, devices, and systems for separating any composite fluid. Accordingly, the present disclosure is not limited to separating blood components from whole blood.

[0117] With reference to FIG. 1, a perspective view of the operating environment 100 of the apheresis system 200 is shown in accordance with embodiments of the present disclosure. The working environment 100 may include an apheresis system 200, a donor 102, and one or more connections (e.g., donor supply tube 104, cassette inlet tube 108A, anticoagulant tube 110, etc.) extending from donor 102 to apheresis system 200 and/or vice versa. As shown in FIG. 1, the donor supply tube 104 may be fluidly connected to at least one blood vessel, such as a vein, of the donor 102 via venipuncture. For example, a cannula connected to the end of the donor delivery tube 104 may be inserted through the skin of the donor 102 and into a target site or vein. This connection may provide an intravenous pathway for blood to flow from the donor 102 to the apheresis system 200, and/or for blood components to flow back to the donor 102. In some embodiments, the fluid paths and connections may form the extracorporeal tubing pattern of the apheresis system 200 .

[0118] Blood supplied from donor 102 may flow along donor supply tube 104 through tubing connector 106 and along cassette inlet tube 108A into soft cassette assembly 300. The soft cassette assembly 300 may include one or more fluid control paths and valves to selectively control the flow of blood to and/or from the donor 102. The apheresis system 200 may include a supply of anticoagulant contained in an anticoagulant (AC) bag 114. The anticoagulant can be pumped through at least the anticoagulant tube 110 and the tubing connector 106, preventing coagulation of blood in the apheresis system 200.

[0119] Anticoagulants may include one or more of, but are not limited to, citrate and/or unfractionated heparin. The AC bag and other bags or bottles described herein can be made from, for example, one or more of, but not limited to: polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene vinyl acetate (EVA), rubber, silicone, thermoplastics, thermoplastic elastomer, polymers, copolymers and/or combinations thereof. The volume of AC in the AC bag 114 may vary based on various factors, including the weight of the donor 102, volumetric blood flow from the donor, etc. In one example, the volume in the AC bag 114 may be from 250 to 500 ml, although the volume in the AC bag 114 may be larger or smaller than this volume.

[0120] In some embodiments, the apheresis system 200 may include a plasma collection bottle or container 122, a saline fluid contained in a saline bag 118, and one or more lines or tubes 116, 120 (e.g., a fluid-carrying tube, etc. ...) connecting the saline bag 118 and plasma collection bottle 122 to the extracorporeal tubing circuit of the apheresis system 200. The amount of saline solution provided in the saline bag 118 may be from 500 to 800 ml, although the volume in the saline bag 118 may be greater or less than this volume. A typical donation of a blood component, such as plasma, can be 880 ml. Thus, the plasma collection bottle 122 can hold at least this amount of plasma. In some embodiments, the plasma collection bottle 122 may include a connection point positioned at, adjacent to, or in physical proximity to the substantially lowermost portion of the plasma collection bottle 122 (for example, when the plasma collection bottle 122 is installed in the plasma collection frame 232C, as shown in Fig. 2A). The connection point may include one or more connectors that are configured to connect to plasma tube 120 to receive and/or transmit plasma. The location of the connecting point at the bottom of the plasma collection bottle 122 may allow the plasma contained in the plasma collection bottle 122 to be moved from the plasma tube 120 back through the lines as disclosed herein without entrapping air bubbles, etc. In some embodiments, the bottle 122 The plasma collection may be in the form of a flexible bag, a rigid container, and/or another container, and thus the plasma collection bottle 122 is not limited to bottles or bottle-like containers.

[0121] In FIG. 2A is a perspective view of the apheresis system 200 described in FIG. 1. The apheresis system 200 can provide a continuous whole blood separation process. In one embodiment, whole blood may be collected from donor 102 and provided substantially continuously to the blood component separation device of the apheresis system 200, where the blood may be separated into various components and at least one of these blood components may be collected from the apheresis system 200. In some embodiments, one or more separable blood components can either be collected for later use or returned to the donor 102. Blood can be collected from the donor 102 and sent to a centrifuge of the apheresis system 200 through an opening 220 in the access panel 224 of the apheresis system 200. In one embodiment, the tubing 104, 108A, 108B, 112, 116, 120 used in the extracorporeal tubing circuit may together define a closed, sterile, and disposable blood component collection system or kit, which may be further described later herein.

[0122] Examples of apheresis systems, plasmapheresis, and other separation systems that can be used with embodiments of the present disclosure, for example, as an apheresis system 200 include, but are not limited to, the SPECTRA OPTIA® apheresis system, the COBE® spectra apheresis system, and the automated TRIMA ACCEL® blood collection system, all from Terumo BCT, Lakewood, Colorado.

[0123] The operation of the various pumps, valves, and blood component separation device or centrifuge may be controlled by one or more processors included in the apheresis system 200, and may advantageously comprise a plurality of embedded computer processors that are part of the computer system. The computer system may also include components that allow the 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. d.); communications/networking devices (eg, wired such as modems/network cards, or wireless such as Wi-Fi); input devices such as keyboard(s), touch-sensitive screen(s), camera(s) and/or microphone(s); and output device(s), such as display(s) and audio system(s), etc. To assist the operator of the apheresis system 200 in various aspects of its operation, an embodiment of a blood component separation device or centrifuge may include a graphical user interface with display that includes an interactive touch-sensitive screen.

[0124] The apheresis system 200 may include a housing 204 and/or structural frame, a cover 210, an access panel 224 located at the front portion 202 and/or rear portion 206 of the apheresis system 200, and one or more supports 232A–C, including hooks, stands, frames, brackets, protrusions, plates, and/or other support members for holding, positioning, and/or otherwise supporting the bag or container 114, 118, 122. In some embodiments, elements of the apheresis system 200 may be described with reference to the coordinate system 103 and/or one or more axes thereof. The housing 204 may include a machine frame (e.g., made of welded, bolted and/or connected structural members, extruded material, beams, etc.) to which one or more panels, covers 210, doors, subassemblies, and/or are attached. or components. In one 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 208, 212, 216, and/or a fluid valve control system 228 (e.g., plasma and saline valve control etc.).

[0125] The access panel 224 may include one or more handles, locks, and a pivot or hinge axis 226 (e.g., a door hinge, a piano hinge, a continuous hinge, a clean room hinge, etc.). In either case, the access panel 224 may be selectively opened to provide access to the interior of the apheresis system 200 and more specifically to the blood separation assembly or centrifuge. In one embodiment, the access panel 224 may provide access for centrifuge loading and/or unloading of one or more components in a blood component collection kit. Details of the centrifuge are described in more detail at least with respect to FIG. 4A to 4L herein.

[0126] The interior of the apheresis system 200 may be divided into at least a centrifuge portion and a control portion. For example, the centrifuge portion may include a cavity configured to receive the centrifuge, a rotation motor, and associated hardware. This region may be physically separated from the control portion through one or more walls of the cavity. In some embodiments, access to a control portion (e.g., configured to house or otherwise contain a motor controller, CPU or processor(s), electronics, wiring, etc.) may be provided through a securely mounted housing panel 204 and/or panel , separate from the access panel 224.

[0127] In some embodiments, the apheresis system 200 may include a plurality of pumps 208, 212, 216 configured to control the flow of a fluid (e.g., blood and/or blood components, anticoagulant, saline, etc.) through the system 200 apheresis. For example, the apheresis system 200 may include a suction pump 208 that controls the flow of blood to and/or from the donor 102 into the apheresis system 200 centrifuge. The suction pump 208 may be engaged with a portion of the circuit inlet tube 108B positioned between the soft cassette assembly 300 and the centrifuge of the apheresis system 200. In some embodiments, 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 the plasma collection bottle 122 and/or vice versa. Additionally or alternatively, return pump 212 may control the flow of saline (eg, supplied from saline bag 118) throughout the blood component collection kit and/or apheresis system 200. The anticoagulant pump 216 may be engaged with a portion of the anticoagulant tubing 110 to selectively control the flow of anticoagulant throughout the blood component collection kit of the apheresis system 200 . As shown in FIG. 2A, pumps 208, 212, 216 may be placed at least partially on the top cover 210 of the apheresis system 200.

[0128] In FIG. 2B and 2C show various perspective views of the pump 208, 212, 216 of the apheresis system 200 in accordance with embodiments of the present disclosure. Although the suction pump 208 is shown and described in conjunction with FIG. 2B and 2C, it should be appreciated that other pump assemblies of the apheresis system 200, i.e., return pump 212 and anticoagulant pump 216, may comprise a design substantially similar, if not identical, to the described suction pump 208.

[0129] The suction pump 208 may include a pump cover 236 or housing configured to at least partially surround the moving elements of the suction pump 208. In some embodiments, the pump cover 236 may include a hinged tube guard 240 that is configured to open and close around rotation axis 242 tube protection. In one embodiment, the tube guard 240 may be attached to the pump cover 236 through one or more fasteners positioned along the axis of rotation 242 of the tube guard. As shown in FIG. 2B and 2C, the blood provided by the donor 102 can be transferred or sucked by the suction pump 208 into the centrifuge in the first suction or centrifuge direction 250A. Additionally or alternatively, blood or other fluid may be transferred or sucked by the suction pump 208 to the donor 102 in the donor direction 250B opposite the centrifuge direction 250A.

[0130] In some embodiments, the suction pump 208 and/or other pumps 212, 216 may be a tubular pump, a peristaltic pump, a diaphragm pump, and/or another pump configured to manipulate the flow of a fluid (e.g., blood, blood components, anticoagulant, saline, etc.) in at least a portion of the tubing. For example, pumps 208, 212, 216 may include a motor operatively coupled to a rotating contact tube assembly. In operation, a tube (eg, circuit inlet tube 108B, circuit outlet tube 112, anticoagulant tube 110, etc.) may be inserted into the leading tube guide 244, the tube pressure block 248, and the end tube guide 252 adjacent the rotating tube contact head. . In one embodiment, the tube pressure block 248 may be moved away from the rotating tube contact head or pump 208, 212, 216 to provide a clearance load area, or vice versa. The rotating tube contact head may include a plurality of rotary pressure rollers 268 configured to rotate about respective pressure roller rotation axes 264. Each of the rotary pressure rollers 268 may be positioned between a first rotary pump plate 272A and a second rotary pump plate 272B, where the plates 272A, 272B are rotatable about a pump rotation axis 260. In some embodiments, rotary pressure rollers 268 may be positioned at the periphery of the rotary pump plates 272A, 272B.

[0131] One or more pumps 208, 212, 216 may incorporate, or operate similarly to, a Pulsafeeder® model UX–74130 peristaltic pump, the Pulsafeeder® MEC–O–MATIC series of pumps, all manufactured by Pulsafeeder Inc., Punta Gorda, Florida, without restrictions. Other examples of 208, 212, 216 pumps may include, but are not limited to, the INTEGRA DOSE IT laboratory peristaltic pump manufactured by INTEGRA Biosciences AG, Switzerland, and the WELCO WP1200, WP1100, WP1000, WPX1 and/or WPM series of peristaltic pumps, all manufactured WELCO Co., Ltd., Tokyo, Japan.

[0132] When a tube is loaded into the leading tube guide 244, the tube pressure block 248, and/or the end tube guide 252, at least some of the rotary pressure rollers 268 can be driven to engage, contact, or otherwise compress the tube positioned between the rotary head contact with the tube and tube pressure block 248. As the rotary pump plates 272A, 272B rotate about the pump rotation axis 260, the rotary pressure rollers 268 may compress the tube portion between the pump 208, 212, 216 and the tube pressure unit 248, positively displacing the fluid within the tube portion in a particular direction 250A, 250B. how the rotary pressure rollers 268 move. For example, when the rotary pump plates 272A, 272B are rotated in a counterclockwise direction about the pump rotation axis 260, the rotation of the rotary pressure rollers 268 compressing the tube between the rotary pressure rollers 268 and the tube pressure block 248 can displace or pump fluid in the centrifuge direction 250A . As another example, when the rotary pump plates 272A, 272B are rotated in a clockwise direction about the pump rotation axis 260, the rotation of the rotary pressure rollers 268 compressing the tube between the rotary pressure rollers 268 and the tube pressure block 248 can displace or pump fluid into direction 250B donor. When not actively pumping, pump 208 may be maintained in a state where at least one rotary pressure roller 268 continues to occlude tube 108B, or in a state where rotary pressure roller 268 does not occlude tube 108B. Thus, pump 208, based on the non-moving state, can also act as a “valve” to prevent or allow fluid movement. This capability may also be available when using pumps 212 and 216.

[0133] The tube guard 240 and pump cover 236 may serve to protect the operator (e.g., phlebotomist, apheresis technician, etc.) and/or donor 102 from accidental contact with one or more moving parts of the pumps 208, 212. 216. In one embodiment, the tube guard 240 may be held in a closed position through one or more guard closure members 254 housed in the tube guard 240, the leading tube guide 244, the tube pressure block 248, and/or the end tube guide 252. In some cases, these guard closure elements 254 may be magnets contained in the tube guard 240, the leading tube guide 244, the tube pressure block 248, and/or the end tube guide 252. In some embodiments, the pump 208, 212, 216 may be stopped or prevented from moving/operating when the tube guard 240 is opened. In this embodiment, the guard-covered sensor may be included in the guard-cover element 254, guides 244, 252, and/or tube pressure block 248.

[0134] One or more fluid control valves may be used to control the route or direction of fluid flow carried throughout the apheresis system 200 tubing. In some embodiments, the apheresis system 200 may include a plasma and saline valve control system 228 located adjacent to the saline bag 118 and/or the plasma collection bottle 122 . The plasma and saline valve control system 228 is shown in a detailed perspective view in FIG. 2D.

[0135] As shown in FIG. 2D, the circuit output tube 112 may pass through the return pump 212 and connect to the saline and plasma tubing y-connector 280. The saline and plasma tubing Y-connector 280 may allow circuit output tubing 112 to be connected to a saline tubing line 116 and a plasma tubing line 120. The plasma and saline valve control system 228 may include an air detection sensor 284 located at the first end of the saline solution and a plasma valve body 276 and a surrounding portion of the circuit outlet tube 112 . The air detection sensor 284 may be any light, ultrasonic, or other type of sensor that can detect the presence of fluid or air in the circuit outlet tube 112 and provide that signal to the apheresis system 200 controller. Types of air detection sensors 284 may include, for example, SONOCHECK ABD05 manufactured by SONOTEC US Inc. or other similar sensor.

[0136] The saline and plasma valve body 276 may include a plurality of receiving elements (e.g., grooves, channels, receptacles, etc.) that receive a portion of the saline tube 112, 116, 120 and/or y-connector 280 and plasma. When air is detected in the circuit outlet tube 112, the plasma and saline valve control system 228 may selectively actuate one or more fluid control valves 286, 288. In some embodiments, air detection through air detection sensor 284 can be used to signal an operating stage and/or a trigger stage in a control method as disclosed herein.

[0137] The plasma flow control valve 286 and/or the saline flow control valve 288 may be a solenoid valve, a linear actuator, a pinch valve, a pinch valve, a tube valve, and/or other actuator valve configured to selectively change eg, block the flow of fluid associated with a particular portion of the tube 112, 116, 120. As shown in FIG. 2D, the plasma flow control valve 286 may be configured to clamp a portion of the plasma tube 120 at least partially contained within the receiving member of the saline plasma valve body 276. The saline flow control valve 288 may be configured to clamp a portion of the saline tube 116 at least partially contained within the receiving member of the saline plasma valve body 276. In any case, the control valves 286, 288 may include an actuatable retractable pin that is moved from a retracted or partially retracted position to an extended or partially extended position to clamp a portion of the tubing contained within the saline and plasma valve body 276. Although the control valves 286, 288 can completely clamp the tube (for example, completely restricting the flow of fluid through it), it should be appreciated that the control valves 286, 288 can be partially actuated in a position that partially restricts the flow of fluid through a portion of the tube .

[0138] Next, with reference to FIG. 3A, a detailed perspective view of a disposable padded cassette assembly 300 is presented in accordance with embodiments of the present disclosure. The soft cassette assembly 300 may include a base and a cassette access door 304 that is secured to the base through at least one cassette access door hinge and/or latch 308. In some embodiments, the cassette access door 304 can be unlocked by actuating the cassette access door latch 308 and rotated about the cassette access door hinge axis 306. The padded cassette assembly 300 may be configured with one or more padded cassette receiving elements 324 to at least partially receive and/or accommodate the padded cassette 340 therein. The soft cassette 340 may be part of a blood component collection kit described herein. For example, the soft cassette 340 may be positioned between the cassette inlet tube 108A and the extracorporeal tubing circuit inlet tube 108B. In some embodiments, the soft cassette 340 may include one or more elements to control the flow of blood and/or blood components from the donor 102 to the apheresis system 200 and/or vice versa.

[0139] The soft cassette assembly 300 may include an air detection sensor 312, a fluid sensor 316, and one or more fluid control valves 320A-C configured to control the route or direction of fluid flow through the soft cassette 340. In some embodiments, these components may be incorporated into the cassette access door 304, base, and/or housing portion 204 of the apheresis system 200. Similar to the security closure element 254 described in conjunction with FIG. 2B-2C, the soft cassette assembly 300 may include one or more door closure elements 328. These features 328 may include, but are not limited to, magnetic gripping devices, projections, tabs and slots, and/or other connections. In one embodiment, the door closure elements 328 may include pressure contact surfaces configured to retain or at least partially position the soft cartridge 340 within the soft cartridge assembly 300.

[0140] Examples of valves 320A-C may include, but are not limited to, a solenoid valve, a linear actuator, a clamp valve, a pinch valve, a tube valve, and/or other actuator valve configured to selectively change, for example , block the flow of fluid (e.g., cross-sectional area, etc.) associated with a particular portion of the soft cassette 340. The soft cassette assembly 300 may include a first fluid control valve 320A configured to clamp a portion of the soft cassette 340 adjacent to cassette inlet tube 108A. The second fluid control valve 320B may be configured to clamp a portion of the soft cassette 340 adjacent to the circuit inlet tube 108B. The fluid control outlet valve 320C may be configured to clamp a portion of the soft cassette 340 along a branching tube extending from a point adjacent to the cassette inlet tube 108A to a point adjacent to the circuit inlet tube 108B. In any case, the valves 320A-C may include an actuatable retractable pin that is moved from a retracted or partially retracted position to an extended or partially retracted position to clamp a padded cassette portion 340 contained in the padded cassette assembly 300. Although the valves 320A-C may completely clamp the flow paths in the soft cassette 340 (e.g., completely restricting the flow of fluid therethrough), it should be appreciated that the valves 320A-C may be actuated partially in a position that partially restricts the flow of fluid through part of the soft cassette 340.

[0141] Sensors 312, 316 may be one or more of an ultrasonic detector, a pressure sensor, a magnetic position sensor, and/or the like. In some cases, fluid sensor 316 may determine whether fluid is present in the soft cassette 340 based on the position of the magnet relative to a portion of the soft cassette 340. For example, when a portion of the soft cassette 340 is filled with fluid, the magnet may be positioned at a first position from the surface of the soft cassette 340. On the other hand, when a portion of the padded cassette 340 is filled with air, the force from the magnet may compress the padded cassette portion 340 into a second position closer to the surface of the padded cassette 340 than the first position. In any case, the detection of air or fluid through the air detection sensor 312 and the fluid sensor 316, respectively, can be used to signal an operating stage and/or a trigger stage in a control method as disclosed herein.

[0142] In FIG. 3B through 3D illustrate various views of a soft cassette 340 in accordance with embodiments of the present disclosure. As provided above, the soft cassette 340 may be part of a blood component collection kit. For example, the soft cassette 340 may be a disposable component used in the blood separation methods described herein. In some embodiments, the soft cassette 340 may be constructed from a substantially pliable and/or flexible material. The pliable material may be chemically inert and/or able to withstand sterilization and cleaning operations, temperature and/or processing. The soft cassette 340 may be constructed from polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene vinyl acetate (EVA), rubber, silicone, thermoplastic, thermoplastic elastomer, polymers, copolymers, and/or combinations thereof. In some embodiments, the soft cassette 340 may be formed by molding, rotomolding, casting, injection molding, or otherwise formed from one or more of the materials described above.

[0143] The soft cassette 340 may include a first cassette port 360A, a second cassette port 360B, and a flow lumen 370 extending between the first and second cassette ports 360A-B. In some embodiments, the first and/or second ports 360A-B of the cassette may be configured to receive and/or be fluidly coupled to one or more tubing from a blood component collection kit. For example, the first cassette port 360A may be mated to the cassette inlet tube 108A and the second cassette port 360B may be mated to the circuit inlet tube 108B. These interfaces may be air and/or fluid tight. In one embodiment, the first and/or second cassette ports 360A-B may include an opening disposed in a soft cassette 340 that is elastically stretchable around the end of a tube (e.g., cassette inlet tube 108A, circuit inlet tube 108B, etc. .).

[0144] Blood from donor 102 may be directed along one or more fluid paths housed in the soft cassette 340. In one embodiment, blood may be directed along flow lumen 370 from first cassette port 360A to second cassette port 360B. In some embodiments, this flow path may direct blood through the drip chamber 354 of the soft cassette 340. In some embodiments, blood and/or other fluids returned to the donor 102 may be directed along the flow lumen 370 from the second cassette port 360B to the first cassette port 360A .

[0145] The soft cassette 340 may include a fluid bypass path provided by a first bypass leg 358A having a bypass flow lumen 364 that is fluidly coupled to a portion of the bypass lumen 370 adjacent to or as part of the first cassette port 360A. cassette. In some embodiments, the bypass flow lumen 364 may extend from a point of the bypass lumen 370 adjacent the first cartridge port 360A along the first bypass leg 358A through the fluid pressure ring 362 to the second bypass lumen 358B and then reconnect to the bypass lumen 370 at a point adjacent to the second cassette port 360B or as part of a second cassette port 360B. As the name suggests, the bypass flow lumen 364 provides a flow path in the soft cassette 340 that bypasses the drip chamber 354.

[0146] Controlling the flow path or directing fluid into the soft cassette 340 may include actuating the fluid control valves 320A-C of the soft cassette assembly 300 to interact with various elastic regions 350A-C to block and/or open portions of the flow path. lumen 370 and/or bypass lumen 364 flow. The first elastic region 350A provides a valve region with a clamp at a point along the flow lumen 370 between the first cartridge port 360A and the drip chamber 354 near the first cartridge end 342 in the soft cartridge 340. When the first fluid control valve 320A is actuated, the valve 320A can clamp the direct flow a lumen 370 closes at this first elastic region 350A, restricting or completely preventing fluid flow at that point in the soft cassette 340. The second elastic region 350B provides a clamping valve area at a point along the flow lumen 370 between the second cassette port 360B and the drip chamber 354 near the second end of the cartridge 346 (eg, opposite the first end 342 of the cartridge). When the second fluid control valve 320B is actuated, the valve 320B may clamp the flow lumen 370 closed in this second elastic region 350B, limiting or completely preventing the flow of fluid at that point in the soft cassette 340. As can be understood, the third elastic region 350C , positioned along the first bypass 358A adjacent the fluid pressure ring 362, may include a clamping valve area at a point along the flow bypass 364. When the fluid control release valve 320C is actuated, the valve 320C may clamp the flow bypass 364 closed in this third elastic region 350C, limiting or completely preventing the flow of fluid through the flow bypass 364.

[0147] As shown in the vertical sectional view of FIG. 3C, formed through a plane extending through the co-flow lumen 370 and the drip chamber 354, the co-flow lumen 370 extends from the first cassette port 360A through the inner chamber volume 374 of the drip chamber 354 to the second cassette port 360B. The flow lumen 370 may be formed as a fluid passage extending within the first tube section 368A, the inner chamber volume 374, and the second tube section 368B of the soft cassette 340.

[0148] In some embodiments, the soft cassette bypass 340 may include a fluid pressure ring 362 through which fluid can flow from the first bypass leg 358A to the second bypass leg 358B and/or vice versa. In one embodiment, a pressure diaphragm 380 may be formed in the material of the soft cassette 340 in a region within or adjacent to the fluid pressure ring 362. The fluid pressure ring 362 and the pressure diaphragm 380 are illustrated in vertical sectional view in FIG. 3D, made through a plane extending through the fluid pressure ring 362 and part of the first and second bypass branches 358A-B. Pressure diaphragm 380 may provide a contact, or sensing, surface for fluid sensor 316 to detect whether fluid pressure ring 362 and/or flow bypass 364 contains a certain amount of fluid, air, and/or combinations thereof. As provided above, as a portion of the fluid pressure ring 362 is filled with fluid, the fluid may provide higher resistance to movement than when the fluid pressure ring 362 is filled with air. This resistance difference may be measured via fluid sensor 316 to determine, among other things, the amount and/or type of fluid (e.g., air, blood, etc.) in flow bypass 364 and/or fluid pressure ring 362 environment.

[0149] In FIG. 4A is a perspective view of the centrifuge assembly 400 of the apheresis system 200 in accordance with embodiments of the present disclosure. The centrifuge assembly 400 may be located within the interior of the apheresis system 200 . The interior space may be at least partially enclosed by one or more elements of the centrifuge housing 204 and/or chamber. Access to the interior and centrifuge assembly 400 may be provided through an access panel 224 located at the front portion 202 of the apheresis system 200. For example, access panel 224 of FIG. 4A is shown in an open position, open along the hinge axis 226. As provided above, the hinge axis 226 may correspond to a door hinge, a continuous hinge, a clean room hinge, and/or some other panel hinge.

[0150] The centrifuge assembly 400 can be effectively mounted within the apheresis system 200 such that the assembly 400 is rotatable relative to the housing 204 and/or other elements of the apheresis system 200. The centrifuge assembly 400 may be loaded with one or more parts of a blood component collection kit by guiding a tube (e.g., circuit inlet tube 108B and circuit outlet tube 112, etc.) into the interior of the apheresis system 200 (e.g., through the opening 220 represented by in FIG. 2A), connecting a portion of the blood component collection circuit 520 to a fixed circuit connection 402 and inserting a blood component collection reservoir 536 into the filler 460. The fixed circuit connection 402 keeps the circuit inlet tube 108B and the circuit outlet tube 112 in a fixed position and can prevent kinking of the tube 108B, 112 outside the apheresis system 200. In some embodiments, blood component collection circuit 520 may be coupled to fixed circuit connection 402 through one or more wedge or rigid connection elements.

[0151] In FIG. 4B through 4C show various perspective views of the centrifuge assembly 400 separate from the apheresis system 200 for the purpose of clarity of description. The centrifuge assembly 400 may include a split centrifuge housing 404 including a lower housing 404A pivotally connected to an upper housing 404B. The upper housing 404B may be opened to provide access for loading a blood component collection reservoir or other blood component collection kit component into the centrifuge assembly 400. In some embodiments, the upper housing 404B may be rotated about a split housing rotation axis 406 (eg, in the form of a hinge, pin, fastener, stepped bolt, etc.).

[0152] The different halves (eg, lower housing 404A and upper housing 404B) of the split centrifuge housing 404 may be configured to lock and/or unlock together. Unlocking the upper housing 404B and lower housing 404A may provide access to the interior of the centrifuge assembly 400. This selective locking can be achieved by rotating the upper housing 404B relative to the lower housing 404A about the centrifuge rotation axis 430. Although the split centrifuge body 404 is shown in FIG. 4B through 4C in the unlocked state, it should be appreciated that the upper housing 404B may be rotated (e.g., in a counterclockwise direction) about the centrifuge rotation axis 430 to engage one or more locking lugs 428 or upper housing members 404B with locking slots 432, housed in the lower housing 404A (as shown in FIG. 4C). When in the unlocked position, the upper housing 404B can be opened or rotated about the split housing rotation axis 406 to load the centrifuge assembly 400 with a blood component collection circuit 520 and/or a blood component collection reservoir 536. When in the locked position, the upper housing 404B is rotationally locked relative to the lower housing 404A, and the two halves of the separate centrifuge housing 404 locked together can be rotated together during a centrifuge or blood separation operation.

[0153] The centrifuge assembly 400 may include at least one clockwise rotation stopper 408A, a counterclockwise rotation stopper 408B, a clockwise upper housing rotation flag 410A, and/or a counterclockwise upper housing rotation flag 410B. In some embodiments, the rotation stops 408A, 408B may be rotationally locked relative to the centrifuge rotation axis 430 of the lower housing 404A. Rotation flags 410A, 410B may be attached or formed in the upper housing 404B and configured to contact associated rotation stops 408A, 408B to prevent excessive rotation of the upper housing 404B relative to the lower housing 404A when locking and/or unlocking the two halves of the split housing 404. centrifuges together. For example, when the upper housing 404B is rotated in a clockwise direction, or unlocked, about the centrifuge rotation axis 430, a portion of the upper housing clockwise rotation flag 410A may contact the clockwise rotation stopper 408A, preventing further rotation in the clockwise direction. Additionally or alternatively, when the upper housing 404B is rotated in the counterclockwise direction, or locked, about the centrifuge rotation axis 430, a portion of the upper housing counterclockwise rotation flag 410B may contact the counterclockwise rotation stopper 408B, preventing further rotation in the counterclockwise direction. arrows. In some embodiments, the split centrifuge body 404 may include one or more locking elements configured to hold the halves of the split centrifuge body 404 in a locked state while the locking elements are engaged.

[0154] In one embodiment, the split housing 404 of the centrifuge may include 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 about the axis of rotation 406 of the split housing. The pull ring 412 may include an opening through which a user can insert a finger and apply a pulling force to rotate the upper housing 404B.

[0155] The centrifuge assembly 400 may include a rotor and motor assembly 414 that is controlled and/or powered through an electrically coupled electrical cable 420. The electrical cable 420 may include a connector that is coupled to a controller, processor, and/or power source. This electrical cable 420 may transmit power and/or data signals between the rotor and motor assembly 414 and one or more controllers/processors of the apheresis system 200 . The rotor and motor assembly 414 may be configured as a motor and/or a motor portion that rotates the complete centrifuge assembly 400 relative to the apheresis system 200 (eg, relative to a portion of the housing 204 and/or the base of the apheresis system 200). In other words, the rotor and motor assembly 414 may include one or more components that cause the centrifuge assembly 400 (eg, both halves of the separate centrifuge body 404 together) to rotate within the apheresis system 200.

[0156] As disclosed herein, the centrifuge assembly 400 may include one or more elements for guiding, receiving, and/or positioning the components of the blood component collection kit relative to the separate centrifuge body 404. For example, in FIG. 4B, the blood component collection circuit 520 is shown captured in an operative position in the circuit angular position guide 424 containing the circuit grip lever 416. The circuit angular position guide 424 may include a plurality of bearings 417, and/or support surfaces arranged to at least partially support the blood component collection circuit 520 in an operative position. In the operative position, the blood component collection circuit 520 can twist along its length within the support provided by the bearings 417 of the circuit angular position guide 424. For example, the blood component collection circuit 520 may be statically attached at one end to a fixed circuit connection 402 of the apheresis system 200, while the other end of the blood component collection circuit 520 may be attached to a spacer 460 (e.g., an internal rotating component of the centrifuge assembly 400. As the assembly 400 rotates, centrifuge during operation of the centrifuge, twisting of the blood component collection circuit 520 between the fixed circuit connection 402 and the connection on the filler 460 may cause the filler 460 to rotate relative to the split centrifuge body 404 of the centrifuge assembly 400. In one embodiment, the low inertia of the filler 460 coupled with the torsion of the circuit The blood component collection 520 as the centrifuge assembly 400 rotates in the apheresis system 200 may cause the filler 460 to rotate at twice the angular velocity of the split centrifuge body 404 in the same direction of rotation. In this example, when the split centrifuge body 404 is rotated in a counterclockwise direction around centrifuge rotation axis 430 at a first angular velocity, 1ω, the filler 460 may be rotated within the separated centrifuge housing 404 in a counterclockwise direction at a second angular velocity, 2ω (eg, substantially twice the first angular velocity, etc.).

[0157] The centrifuge assembly 400 may include one or more counterbalance features, elements and/or structures positioned about the centrifuge rotation axis 430 of the centrifuge assembly 400. These counterbalance elements may provide an axially balanced centrifuge assembly 400 such that, when rotated on the centrifuge rotation axis 430, the centrifuge assembly 400 may substantially not impart vibration to the apheresis system 200. In one embodiment, the centrifuge balance weight 418 may be attached to a portion of the split centrifuge housing 404 (eg, lower housing 404A and/or upper housing 404B, etc.). This centrifuge balance weight 418 can be selected specifically for the centrifuge assembly 400 and as such can be selectively attached to and removed from the centrifuge assembly 400 . The adjustment of the centrifuge balance weight 418 can be calculated and/or empirically derived to obtain a fully balanced centrifuge assembly 400, particularly when loaded with one or more blood component collection kit elements.

[0158] In FIG. 4C is a rear perspective view of a centrifuge assembly 400 in accordance with embodiments of the present disclosure. A portion of the filler 460 is visible through an opening in the upper housing 404B. The blood component collection circuit 520 is shown in the circuit loading initial position 520A, where the first end is connected to the fill 460 and the second end is statically attached to the fixed circuit connection 402 (not shown). The blood component collection circuit 520 is shown passing through the circuit access gap 436 in the separate centrifuge housing 404. When the blood component collection circuit 520 is loaded into the circuit loading position 520A, a portion of the blood component collection circuit 520 can be partially contained, held, and/or supported by the circuit holding bracket 426. The contour holding bracket 426 may include one or more bearings 417 (e.g., roller bearings, ball bearings, needle bearings, etc. and/or assemblies thereof, etc.) or support surfaces arranged to at least partially support the blood component collection circuit 520 as it rotates relative to the centrifuge assembly 400. In some embodiments, the blood component collection circuit 520 may be rotated about an axis along the length of the flexible circuit 524 (e.g., in an installed or mounted state and/or position, etc.), allowing relative rotational movement of the flexible circuit 524 toward the guide 424 angular position of the contour. For example, the circuit does not "twist" but actually rotates or rolls relative to the circuit angular position guide 424 (e.g., a support structure) between one or more bearings 417. This rotation or torsion, without binding or twisting of the flexible circuit 524, may be referred to herein as like twisting. Twisting allows the flex circuit 524 to transmit rotational force to the core 460 without significantly reducing the internal diameter of the flex circuit 524 lumen. In some cases, there is no reduction in the internal diameter of the flex circuit 524 lumen.

[0159] As described above, when the upper housing 404B is rotated from the rotationally unlocked position shown in FIG. 4B-4C, in the rotationally locked position, a locking lug 428 of the upper housing 404B may engage a locking slot 432 in the lower housing 404A. Additionally or alternatively, when moved to the rotationally locked position, the circuit holding bracket 426 can be rotated, along with the blood component collection circuit 520 and the upper housing 404B, to a position corresponding to the circuit angular position guide 424 along the circuit engaged position 520B. In some embodiments, the circuit engagement lever 416 may guide the blood component collection circuit 520 toward the bearings 417 and/or bearing surfaces of the circuit angular position guide 424 as the upper housing 404B and the blood component collection circuit 520 are rotated into the circuit engagement position 520B. Additional details regarding loading of blood component collection circuit 520 are described in conjunction with FIG. 6A–7B.

[0160] In FIG. 4D through 4F are various schematic cross-sectional views taken through the center of the centrifuge assembly 400 (eg, a dissection of the centrifuge assembly 400 through the centrifuge rotation axis 430, etc.). As described above, the centrifuge assembly 400 may include a lower housing 404A that is pivotally attached to an upper housing 404B via a split housing pivot 406 or hinge. The upper housing 404B may be attached to an upper housing adapter 440, which is rotationally coupled to an upper housing adapter 442, which is attached to a pull ring 412. In one embodiment of the bearing 417, a transition or load-bearing surface may be positioned between the upper housing adapter 440 and the adapter block. 442 of the upper housing, which allows the upper housing 404B to be rotated along the centrifuge rotation axis 430 from a locked position to an unlocked position, and vice versa. The pull ring 412 may be rotationally locked about the centrifuge rotation axis 430 relative to the lower housing 404A. In some embodiments, the upper housing adapter 440 and the upper housing 404B may be formed from a one-piece structure.

[0161] The filler 460 may be statically attached to the filler spindle 434, which is rotatable relative to the upper housing 404B about a centrifuge rotation axis 430. In one embodiment, the filler spindle 434 may be formed from a portion of the filler 460. In either case, one or more support bearing spindles 444 may be positioned between the filler spindle 434 and the upper housing adapter 440, allowing rotation of the filler 460 within the separate centrifuge housing 404 and the assembly. 400 of the centrifuge around the axis 430 of rotation of the centrifuge. In some embodiments, the filler spindle 434 can be held in position through at least one retaining nut 438. The filler 460 and the filler spindle 434 can be rotated together relative to the separate centrifuge housing 404

[0162] In FIG. 4D is a schematic cross-sectional view of the centrifuge assembly 400 in a closed state, for example, before loading the blood component collection circuit 520, in accordance with embodiments of the present disclosure. When the upper housing 404B is unlocked relative to the lower housing 404A, the operator can pull the pull ring 412 to rotate the entire upper housing 404B and filler 460 about the split housing rotation axis 406. In one embodiment, the upper housing 404B and core 460 may be partially opened by rotating the components about the split housing rotation axis 406 in the opening direction 446 as shown in FIG. 4E. As illustrated in FIG. 4E, where the centrifuge assembly 400 is shown in a partially open state, the upper housing 404B and filler 460 are rotated axially from the axis of rotation of the lower housing 430A. In this position, the core 460 can be allowed to rotate about the core rotation axis 430B. When the lower housing 404A and the upper housing 404B are in the closed state, the rotation axis of the lower housing 430A and the filler rotation axis 430B are aligned (to coincide or substantially coincide) to form the centrifuge rotation axis 430.

[0163] Continued rotation of the upper housing 404B and filler 460 about the y-axis of the split housing rotation axis 406 in the opening direction 446 (e.g., through continued pulling of the pull ring 412) may cause the upper housing 404B and filler 460 to rotate substantially 180 degrees relative to the closed position. , presented in Fig. 4D. As shown in FIG. 4F, the centrifuge assembly 400 is in an open, or loading, state. In this position, the upper body 404B and the filler 460 can be rotated outward from the interior of the apheresis system 200. For example, at least a portion of the upper body 404B and/or core 460 may be positioned across the open space of the open access panel 224. In this position, the loading access area 450 may be provided in the connection area 454 of the filler circuit 460. As can be appreciated, the orientation of the upper housing 404B in the open position provides easy access to the interior of the upper housing 404B and the filler 460. Among other things, this arrangement can provide sufficient clearance for an operator to attach the blood component collection circuit 520 to the pad 460 in the circuit connection area 454.

[0164] With reference to FIG. 4G, a perspective view of a core 460 for a centrifuge assembly 400 is shown in accordance with embodiments of the present disclosure. In some embodiments, the core 460 can be created from a lightweight material such as plastic, carbon fiber, aluminum, etc. In one embodiment, the core 460 can be three-dimensionally (3D) printed using a 3D printing machine. For example, aggregate 460 may be produced using an additional manufacturing technique or system, such as fused deposition modeling (FDM), selective laser sintering (SLS), stereolithography (SLA), and/or other additional manufacturing machines. Among other things, these additional rapid prototyping manufacturing techniques can make possible more complex core geometries 460 that may not be possible using standard machining or manufacturing processes. In some embodiments, the material of the core 460 can be selected based on the desired weight of the core 460, the desired physical strength of the core 460 being manufactured, and/or a suitable material for use in the manufacture.

[0165] The filler 460 may include a circuit connection region 454 located substantially at the center of the filler 460. The circuit connection region 454 may include one or more wedge or rigid connection elements for a portion of the blood component collection circuit 520 for engagement. As shown in FIG. 4G, the contour connection region 454 includes a first rigid connection element 478 positioned along a portion of the central axis of the core 460. The first rigid connection element 478 may be a wedge groove, groove, slot, or other element for engaging a mating element located on the collection circuit 520 blood components. In some embodiments, the filler 460 may include a second rigid connection element 480 in the contour connection region 454. The location elements 478, 480 may prevent the blood component collection circuit 520 from rotating in the circuit connection region 454 and/or prevent the blood component collection circuit 520 from disengaging from the connection region 454 of the filler circuit 460.

[0166] In some embodiments, the filler 460 may include a collection insert channel 466 configured to receive, and at least partially accommodate, a blood component collection reservoir from a blood component collection kit and, more specifically, a blood component collection circuit 520 . The collection insert channel 466 may be configured as a groove, a slot, extending outward in a generally helical manner from the center of the core 460. In some embodiments, the collection insert channel 466 may follow a substantially helical path, which may comprise a first portion of a helical path, extending outward from the center of the core 460 to a substantially constant radius (eg, near the center of the core 460) along the length of the periphery of the collection insert channel 466. In either case, may be referred to herein as a helical path or a substantially helical path. The collection insert channel 466 may begin at the channel entrance 468 adjacent the center of the fill body 464 and end at the end of the channel 472 adjacent the point farthest from the center of the fill body 464. As shown in FIG. 4G-4I, the collection insert channel 466 may extend along a substantially helical path 490 extending from a point adjacent to the core rotation axis 430B to the channel end 472. As such, the spiral path 490 may include a channel path break 476 at a point near or adjacent to the channel end 472. This channel path bend 476 may extend a certain distance from the collection insert channel 466 from the center of the aggregate body 464, thereby increasing the centripetal and centrifugal forces at the channel end 472 in the collection insert channel 466. In one embodiment, this channel path break 476 may correspond to a critical inlet and outlet port as radially as possible within the blood component collection reservoir 536 that is inserted or positioned at least partially into the channel 466 of the collection insert 460. In some embodiments, the filler 460 may include one or more filler balancing projections 482 positioned on, in, or near a portion of the filler body 464 . These filler balancing projections 482 may provide axially balanced (e.g., about the filler rotation axis 430B) filler 460, particularly when the collection insert channel 466 includes a blood component collection reservoir and a fluid (e.g., blood, blood components, etc.). d.).

[0167] In FIG. 4I is a schematic planar view of a generally helical receiving channel, or collection insert channel 466, for a filler 460 in accordance with embodiments of the present disclosure. A schematic in-plane view shows a first distance, R1, from the collection insert channel 466 to the center of the aggregate body 464 (e.g., adjacent to the aggregate rotation axis 430B, etc.) at a first point along the substantially helical path 490, and a second distance, R2 , from the collection insert channel 466 to the center of the filler body 464 beyond a point adjacent to the channel path break 476 . As illustrated in FIG. 4I, the second distance, R2, is greater from the center of the core body 464 than the first distance, R1. This increase in distance may provide greater centripetal and centrifugal forces in the channel at a point near or at the end 472 of the channel than at any other point along the substantially helical path 490. In some embodiments, the end of the blood collection reservoir may be substantially coincident with the end 472 of the channel , providing the greatest blood separation forces at the end of the reservoir.

[0168] In FIG. 4J through 4L show another vertical cross-section of the filler 460 and, more specifically, the collection insert channel 466 and the filler insert chamber 492 housed within the filler housing 464. In some embodiments, the collection insert channel 466 may have a cross-section or geometric shape that essentially follows the substantially helical path 490 in the fill body 464. The collection insert channel 466 may include an insert groove configured to receive a substantially flat or empty blood component collection reservoir. A blood component collection reservoir may be inserted into a collection insert channel 466 and a fill insert chamber 492 formed in the fill body 464 along a generally helical path 490. The fill insert chamber 492 may be defined by one or more side walls 494, 496 defining a cavity , which follows substantially the helical path 490. As shown in FIG. 4K, the core insert chamber 492 includes an inner chamber wall 494 separated by a distance from at least one outer chamber wall 496. The core insert chamber 492 may be formed into the core 460 by 3D printing the core 460 and/or by some other metal or plastic forming operation or operations (e.g., casting, molding, forming, etc.). In some embodiments, the aggregate insert chamber 492 may include one or more insert guide members 498. These insert guide elements 498 may be configured to guide, locate, and/or seat a blood component collection reservoir within the filler insertion chamber 492 in the filler 460. Although the filler insertion chamber element 492 is shown as rounded or faceted, the insert guide 498 may include one or more more than a radius, rounding, slope, skew, taper angle, receptacle, groove and/or other shaped material configured to guide and/or orient a portion of the insertable reservoir for collecting blood components.

[0169] In FIG. 4L illustrates various states of fluid collection reservoirs (e.g., blood component collection reservoirs, etc.) disposed within the collection insert channel 466 and filler insert chamber 492 in the filler 460. As described above, the blood component collection reservoir can be insert the collection insert into the channel 466 in a substantially flat, or unfilled, state, S1. In a substantially flat state, S1, the blood component collection reservoir may be sized to fit into the top opening of the collection insert channel 466 and remain in the pre-filling state within the filler insert chamber 492. As the filler 460 begins to rotate and separate blood components from the blood provided by donor 102, the blood component collection reservoir may expand from a substantially flat first state, S1, to an expanded or filled state, S2. In some embodiments, the blood component collection reservoir may be expanded with blood and/or blood components until the walls of the blood component collection reservoir contact the walls 494, 496 of the filler insert chamber 492. In one embodiment, the geometry of the aggregate insert chamber 492 may be designed to optimize the amount of fluid (e.g., maximize the volume of fluid while minimizing the amount of material for aggregate 460) that can be collected and/or separated within the insert chamber 492 filler.

[0170] In FIG. 5A is a schematic view of a blood component collection kit 500 in accordance with embodiments of the present disclosure. The blood component collection kit 500 may include a tube (e.g., one or more of a donor supply tube 104, a cassette inlet tube 108A, a circuit inlet tube 108B, an anticoagulant tube 110, a circuit outlet tube 112, a saline tube 116, a plasma tube 120, etc. etc.), connectors (e.g., one or more of saline and plasma tubing y-connector 106, y-connector 280, tubing fittings 504, tubing fittings 508, bag piercing fittings 512, etc.), soft cassette 340 and a blood component collection circuit 520 .

[0171] The tube may include any tube having a central lumen configured to carry fluid therethrough. The tube can be constructed from polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene vinyl acetate (EVA), rubber, polymers, copolymers, and/or combinations thereof. The connectors may be configured to be fluidly coupled to a tube (eg, at one or more ends of a tube, etc.). The connectors can be inserted into the central lumen of the tube and/or attached to the outside of the tube. In some embodiments, the connectors may be configured with a variety of fittings (e.g., luer lock, twist and/or other small diameter mate, etc.) to provide versatile and/or reliable connections to one or more other fittings, connectors, tubing , needles and/or medical accessories. In one embodiment, the bag piercing fixture 512 may be configured to be inserted into a receiving bag (eg, salt bag 118, etc.).

[0172] The blood component collection circuit 520 may include a flexible circuit 524 positioned between the system static circuit connector 528 and the fill circuit connector 532. The flexible circuit 524 may be configured as a hollow flexible tube configured to receive and/or accommodate at least a portion of the circuit inlet tube 108B and the circuit outlet tube 112. In some embodiments, the flexible loop 524 may be constructed from a thermoplastic elastomer that has increased flexibility to transfer torsion from one end of the flexible loop 524 to the other. These types of elastomers can provide the flexibility of rubber while maintaining the strength and torsion characteristics of plastics. Examples of thermoplastic elastomer may include, but are not limited to, copolyester, DuPont™ Hytrel® thermoplastic elastomers, Eastman Neostar™ elastomers, Celanese Riteflex® elastomers, TOYOBO PELPRENE® and/or other brands of elastomers that have high flexibility and strength characteristics .

[0173] In some embodiments, the blood component collection circuit 520 may include a blood component collection reservoir 536 having a reservoir circuit end 540A and a free reservoir end 540B. The blood component collection reservoir 536 may include a first flow collection chamber 544 coupled to a flexible circuit 524 on a filler circuit connector 532 . In particular, fluid may flow between the circuit inlet tube 108B and the first flow collection chamber 544 through the flexible circuit 524 and connectors 528, 532 and/or vice versa. Fluid flowing in the direction from the reservoir circuit end 540A to the free reservoir end 540B along the first flow chamber 544 may reach the flow chamber transition 548 and enter the second flow chamber 552. In one embodiment, a second collection flow chamber 552 is connected to a flexible circuit 524 in a fill circuit connector 532. In particular, fluid may flow between the circuit outlet conduit 112 and the second flow collection chamber 552 through the flexible circuit 524 and connectors 528, 532 and/or vice versa.

[0174] Details of the blood component collection circuit 520 are illustrated in conjunction with the elevation view of FIG. 5B. The blood component collection circuit 520 may include a flexible circuit 524 configured as a tube containing a first path for a circuit inlet tube 108B and a second path for a circuit outlet tube 112. In some embodiments, the loop inlet tube 108B may extend through the flexible loop 524 and connect to the first flow collection chamber 544 at the reservoir loop end 540A via a fill loop connector 532. Additionally or alternatively, loop outlet conduit 112 may extend through flexible loop 524 and connect to a second flow collection chamber 552 at reservoir loop end 540A via fill loop connector 532. The first path is separated from the second path. This configuration allows blood to flow into the flexible circuit 524 and blood component collection reservoir 536 through the first flow collection chamber 544 and be separated into one or more blood components, which can then be transferred along the second flow collection chamber 552 to the circuit outlet tube 112 in the flexible circuit. 524.

[0175] The first collection flow chamber 544 may be separated from the second collection flow chamber 552 through a flow chamber separator 542 . The flow chamber separator 542 may be a thermally welded portion of the blood component collection reservoir 536 . For example, the blood component collection reservoir 536 may be constructed from layers of material overlapping along the length of the blood component collection reservoir 536. The layers of material may be geometrically shaped (eg, cut or otherwise geometrically shaped, etc.) and thermally sealed along one or more edges to form a fluid reservoir. The flow chamber separator 542 may be formed in the fluid reservoir by heat sealing one layer of material to another layer of material along a path as substantially illustrated. The flow chamber separator 542 does not extend the entire length of the blood component collection reservoir 536, providing a flow chamber transition 548 for fluid (e.g., blood, blood components, etc.) to pass from the first collection flow chamber 544 to the second collection chamber 552 flow and/or vice versa. In one embodiment, the fluid (e.g., blood and/or blood components, etc.) in the blood component collection reservoir 536 contained in the filler insert chamber 492 in the filler 460 may be moved toward the free end 540B of the reservoir along a first flow collection chamber 544 near the end of the flow chamber separator 542 (eg, following the direction of movement of the blood component 546) and into a second flow collection chamber 552. In this example, blood components (e.g., plasma, etc.) can be forced back along a substantially helical path 490 toward the center of the fill body 464 along the second flow collection chamber 552 and through the circuit outlet tube 112 (e.g., into the plasma collection bottle 122 ).

[0176] The blood component collection reservoir 536 may be constructed from polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene vinyl acetate (EVA), thermoplastics, thermoplastic elastomer, polymers, copolymers, and/or combinations thereof. In some embodiments, the blood component collection reservoir 536 may be formed, heat-sealed from multiple layers of material, formed from a single layer of material folded over itself, and/or combinations thereof.

[0177] In some embodiments, the blood component collection circuit 520 may include a plurality of rigid connection elements or wedge elements 530A, 530B configured to rigidly connect portions of the blood component collection circuit 520 relative to the apheresis system 200 and/or the filler 460. For example, circuit 520 The blood component collection includes a first connector location element 530A on the system static circuit connector 528 and a second connector location element 530B on the filler circuit connector 532. Elements 530A, 530B may be provided as a key, tab, and/or other protrusion of material that extends from connector 528, 532. In some embodiments, second connector location element 530B may include elements that connect or mate with first rigid connection element 478 and /or a second rigid connection element 480 in the circuit connection region 454 in the filler 460. Similar, if not identical, rigid connection elements may be associated with or included in the fixed circuit connection 402 of the apheresis system 200.

[0178] In FIG. 5C and 5D are cross-sectional views of the blood component collection reservoir 536 of the blood component collection circuit 520 in accordance with embodiments of the present disclosure. For example, cross-sections show the first flow collection chamber 544 separate from the second flow collection chamber 552 along the length of the blood component collection reservoir 536. In some embodiments, separation may be provided by a flow chamber separator 542 positioned between the first collecting flow chamber 544 and the second collecting flow chamber 552. The flow chamber separator 542 may correspond to a sealed area of the blood component collection reservoir 536 . The flow chamber separator 542 may be formed as a thermally sealed region of material, for example, connecting first reservoir side material 536A to second reservoir side material 536B. In some cases, the first reservoir side material 536A and the second reservoir side material 536B may be a single piece of material folded along an edge (eg, adjacent to one of the upper reservoir seal area 554A or the lower reservoir seal area 554B).

[0179] The cross-section shown in FIG. 5D may correspond to a reservoir 536 for collecting blood components before compaction, and the cross-section shown in FIG. 5C may correspond to a blood component collection reservoir 536 after forming or sealing the upper reservoir seal 554A, the lower reservoir seal 554B, and/or the flow chamber separator 542 (e.g., welding the first reservoir side material 536A to the second reservoir side material 536B, etc. ). Once formed, the width of the reservoir, WB, may correspond to the width of the first flow collecting chamber 544 and/or the second flow collecting chamber 552 in an unexpanded state, S1 (see, for example, FIG. 4L). In operation, as fluid fills at least a portion of the blood component collection reservoir 536, the width of the reservoir, WB, may increase in dimension relative to the measurement shown in FIG. 5C. For example, the width of the reservoir, WB, may increase substantially to the size of the filler insertion chamber 492 in the filler 460. In some embodiments, welding (e.g., RF, ultrasonic, etc.) performed in the manufacture of the blood component collection reservoir 536 may support in the core 460. In one embodiment, the top of the core 460 supports the top two welds and the bottom of the core 460 supports the final weld.

[0180] In FIG. 5E-5H show various perspective views of the blood component collection circuit 520 in a curved state (e.g., FIGS. 5E-5F), as well as views of the curved blood component collection reservoir 536 of the blood component collection circuit 520 inserted into the filler 460 (e.g., FIG. 5G–5H). Various components of the blood component collection circuit 520 may be flexible and/or capable of being shaped or geometrically shaped by the application of force. In some embodiments, this flexibility may be elastic such that shaping the various portions of the blood component collection circuit 520 does not permanently deform the components. In fig. 5E illustrates a blood component collection circuit 520 in a curved state in accordance with embodiments of the present disclosure. For example, flexible loop 524 is shown elastically curved along its length, and blood component collection reservoir 536 is shown following a plurality of bends or curves along its length. The flexible circuit 524 can still transfer fluids provided through the circuit inlet tube 108B to the first flow collection chamber 544 in the blood component collection reservoir 536, and vice versa, while the components are in the flexed state. Additionally or alternatively, the flexible circuit 524 can carry fluids from the second flow collection chamber 552 of the blood component collection reservoir 536 to the circuit outlet tube 112, and vice versa, while the components are in the flexed state.

[0181] In some embodiments, the blood component collection circuit 520 may be preformed, as shown in the perspective view of FIG. 5F to receive the collection insert channel 466 of the filler 460. This preforming may include twisting the blood component collection reservoir 536 of the blood component collection circuit 520 to substantially align with the helical path 490 of the collection insert channel 466. Once preformed, elements of the blood component collection circuit 520 may be aligned with one or more fill elements 460, as shown in FIG. 5G. In one embodiment, the filler circuit connector 532 of the blood component collection circuit 520 may be aligned with the connection region 454 of the filler circuit 460 such that the second rigid connection element 530B of the connector is aligned to engage the first rigid connection element 478. Additionally or alternatively, the blood component collection reservoir 536 may be geometrically shaped or shaped (e.g., by hands, etc.) to align substantially with the helical path 490 of the collection insert channel 466 in the filler 460. In some cases, this shaping or shaping may include aligning the free end 540B of the reservoir in the blood component collection reservoir 536 with the end 472 of the channel in the collection insert channel 466 in the filler 460. When the components are generally aligned with each other, the blood component collection circuit 520 can be moved into towards the collection insert channel 466 and the loop connection area 454 (as shown in FIG. 5G).

[0182] In some embodiments, when the filler circuit connector 532 is moved to and into the connection area 454 of the filler circuit 460, the first rigid connection element 478 may connect and/or hold the second rigid connection element 530B in the filler circuit connector 532 of the component collection circuit 520 blood. This connection may prevent the filler circuit connector 532 from rotating relative to the filler 460. In some cases, the connection may hold the filler circuit connector 532 of the blood component collection circuit 520 within the connection area 454 of the filler circuit 460. In FIG. 5H is a perspective view of a blood component collection circuit 520 loaded into a fill 460 in accordance with embodiments of the present disclosure.

[0183] In FIG. 6A through 6C are schematic cross-sectional views of a centrifuge assembly 400 in various circuit loading states in accordance with embodiments of the present disclosure. The centrifuge assembly 400 shown in FIG. 6A through 6C may correspond to the centrifuge assembly 400 described above, and particularly in conjunction with FIGS. 4D–4F. In particular, in FIG. 6A is a schematic sectional view of a first circuit loading state, FIG. 6B is a schematic sectional view of a second circuit loading state and FIG. 6C is a schematic sectional view of a second circuit loading state for centrifuge assembly 400.

[0184] In FIG. 6A, the centrifuge assembly 400 is shown in the open circuit loading position, where the upper housing 404B is rotated 180 degrees from the closed, or operating, position. This open position may correspond to the position of the centrifuge assembly 400 shown in FIG. 4F. However, in FIG. 6A, the blood component collection circuit 520 is inserted into the filler 460, and the filler circuit connector 532 is connected to the circuit connection area 454 of the filler body 464. The other end of the blood component collection circuit 520 is connected to the fixed circuit connection 402 through a system static circuit connector 528. In this first circuit loading state, the flexible circuit 524 is locked from rotation at the fixed circuit connection 402, but is rotated in conjunction with the filler 460 in the circuit connection region 454.

[0185] In FIG. 6B, the centrifuge assembly 400 is shown in a partially closed position where the upper housing 404B is moved from an open position to a closed or operating position. As the upper housing 404B rotates, the flexible circuit 524 can be moved to a resting position relative to the centrifuge assembly 400. Although the flex circuit 524 is rotationally fixed to the fixed circuit connection 402, the filler 460 can be freely rotated about the filler rotation axis 430B (eg, limited only by the rotationally fixed flex circuit 524).

[0186] In FIG. 6C, the centrifuge assembly 400 is shown in a closed or operative position where the upper housing 404B can be locked onto the lower housing 404A (so that the lower housing 404A and the upper housing 404B can be rotated together about the centrifuge rotation axis 430). In this position, the flexible circuit 524 can extend from the connection area 454 of the filler circuit 460 through the circuit access gap 436 of the separate centrifuge body 404 to the fixed circuit connection 402. In some embodiments, the flexible circuit 524 may be freely movable within the circuit access gap 436 with or without contact with one or more portions of the separate centrifuge housing 404. In this position, as the centrifuge assembly 400 rotates about the centrifuge rotation axis 430, the flexible circuit 524, rotationally fixed in the fixed circuit connection 402, can be twisted along the length of the flexible circuit 524, thereby rotating the filler 460 within the centrifuge assembly 400 (e.g., along the axis 430 centrifuge rotation). As provided above, the rotation of the aggregate 460 relative to the centrifuge assembly 400 may occur in a 2:1 ratio. For example, as the centrifuge assembly 400 rotates one revolution, the rotationally fixed flexible circuit 524 (e.g., fixed in the fixed circuit connection 402) rotates in the circuit connection region 454 (e.g., attempting to untangle the twist by rotating the centrifuge assembly 400, etc. ), thereby rotating the filler 460 in the same rotational direction as the centrifuge assembly 400, but essentially two revolutions. This rotation of the core 460, by twisting the flexible loop 524 along its length, does not require transmission between the centrifuge assembly 400 and the core 460.

[0187] In FIG. 7A through 7B are schematic in-plane views of a centrifuge assembly 400 that automatically loads the circuit into an operating position (eg, blood separation) for centrifugation. The centrifuge assembly 400 shown in FIG. 7A-7B may correspond to a centrifuge assembly 400 as previously discussed and/or as described in connection with FIGS. 4A-4F and FIGS. 6A–6C. When the blood component collection circuit 520 is loaded into the centrifuge assembly 400, as illustrated in FIG. 6C, the flexible loop 524 can be automatically loaded into the engaged loop position 520B as shown in FIG. 7A–7B.

[0188] In one embodiment, when the upper housing 404B is locked onto the lower housing 404A, a flexible circuit 524 may extend from the circuit connection area 454 of the filler 460 to the fixed circuit connection 402 of the apheresis system 200. Although the flexible circuit 524 may be rotationally secured in the fixed circuit connection 402 on the system static circuit connector 528, the flexible circuit 524 passing through the circuit access gap 436 in the separate centrifuge body 404 may not initially be retained, or at least at least partially captured by the contour angular position guide 424 and/or other elements of the centrifuge assembly 400. This state of the flexible loop 524 relative to the loop angular position guide 424, or loop bracket, may correspond to the unengaged loop state 700A. In other words, the flexible loop 524 can be oriented at an angle, α, relative to the loop angular position guide 424, the loop position stop plate 704, and/or one or more loop torsion support bearings 708, or sets of bearings. In some embodiments, the supporting circuit torsion bearing 708 may correspond to the bearings 417 described in conjunction with FIG. 4B–4C. The contour holding area or channel may be formed by a contour position stop plate 704 and/or one or more contour torsion support bearings 708 positioned along the length of the upper housing 404B. In some embodiments, this orientation may be designed to allow access and/or ease of loading during loop loading described in conjunction with FIG. 6A–6C.

[0189] As the centrifuge assembly 400 rotates in the loop and fill rotation direction 712 about the centrifuge rotation axis 430, the flexible loop 524 can be moved from the untrapped loop state 700A to the captured loop state 700B shown in FIG. 7B. This rotation may be caused by rotation of the centrifuge assembly 400 and/or aggregate 460 by the operator in the direction of rotation of the circuit and aggregate 712 and/or by the rotor and motor assembly 414, causing the centrifuge assembly 400 to rotate about the centrifuge rotation axis 430. In some embodiments, as the flexible loop 524 rotates in the loop and fill rotation direction 712, the outer portion of the flexible loop 524 may contact the loop position stop plate 704 or other rotational locking surface of the loop angular position guide 424.

[0190] While the flexible circuit 524 is held or at least partially contained in the circuit angular position guide 424, a portion of the flexible circuit 524 can be moved in one or more circuit torsion support bearings 708. As described above, the flexible circuit 524 can be rotationally locked into the fixed circuit connection 402 through the first rigid connector element 530A of the system static circuit connector 528 that is associated with the blood component collection circuit 520. This rotationally fixed connection prevents the flexible circuit 524 from rotating relative to the apheresis system 200 at the fixed circuit connection 402. The other end of the flexible loop 524 may be coupled to the connection region 454 of the filler loop 460, where the end can be moved with the filler 460 and/or the centrifuge assembly 400. As the centrifuge assembly 400 continues to rotate in the loop and filler rotation direction 712, forces from the flex loop 524 attempting to untangle, or keep from seizing, rotate the filler 460 and the end of the flex loop 524 attached thereto.

[0191] In any case, when the fluid separation methods described herein are performed, the rotation of the centrifuge assembly 400 can be stopped and the split centrifuge body 404 can be opened to remove the disposable elements of the blood component collection kit 500 from the centrifuge assembly 400. In some cases, flexible loop 524 can be moved from captured loop state 700B illustrated in FIG. 7B to the uncaptured circuit state 700A shown in FIG. 7A, by rotating the centrifuge assembly 400 and/or the filler 460 in a direction opposite to the direction of rotation 712 of the circuit and filler.

[0192] A functional diagram of the apheresis system 200 may be as shown in FIG. 8 in accordance with embodiments of the present disclosure. A functional diagram depicts the components described earlier in this specification, FIG. 1-7B to describe the operation of the system 200 to extract plasma or other blood components from the whole blood of donor 102 during an apheresis procedure or process.

[0193] System 200 may include an anticoagulant (AC) pump 216. AC pump 216 pumps fluid into AC tube 110 from AC bag 114. AC pump 216, AC tube 110 and/or AC bag 114 may be as previously described. AC tube 110 may also include an AC air detection sensor (ADS) 804 for detecting air or fluid in AC tube 110. AC ADS 804 may be the same or similar in type and/or function to sensor 284 and/or or sensor 312 described previously. AC tube 110 may intersect with and be fluidly associated with donor supply tube 104 and cartridge inlet tube 108A in tube connector 106. Tube connector 106 can be any type of connection between tube 110, 104 and/or 108A, as previously described.

[0194] The donor supply tube 104 extends from the donor 102, where the donor 102 can be punctured using a lumen needle or other device that allows whole blood to flow from the donor 102 into the apheresis system 200 and allows blood components to flow back to the donor 102. The tube 108A can go to the soft cassette 340. In addition, a donor air detection sensor 312 may be placed on or in the tube 108A to detect the presence of fluid and/or air in the tube 108A.

[0195] As previously stated, the soft cassette 340 may include a first cassette port 360A, which may function as, contain, and/or be substantially proximate to a "Y" connector or section or branches that divide the tube 108A into a first bypass branch 358A and the first tube section 368A (the "Y" section is designated 360A). The two tube sections 358 and 368 may be reconnected to a second cassette port 360B, which may also function as, contain, and/or be substantially similar to a second “Y” connector or section (the second “Y” section is designated 360B). The tube 358 is separated by a fluid sensor 316, which divides the tube 358 into a first bypass branch 358A and a second bypass branch 358B. Likewise, tube 368 is separated by a drip chamber 354, which divides tube 368 into a first tube section 368A and a second tube section 368B.

[0196] The first tube section 368A may include a first fluid control valve 320A. The second tube section 368B may similarly include a second fluid control valve 320B. The first bypass branch 358A may likewise include a fluid control outlet valve 320C. As such, different sections of tube 368A, 358A, 358B, and 368B may be isolated by valves 320A, 320B, and/or 320C based on the configuration of system 200 and depending on the operation of system 200.

[0197] The drip chamber 354 may be positioned between the first tube section 368A and the second tube section 368B. The drip chamber 354 can collect a specified volume 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 further disclosed herein. The fluid sensor 316, as previously described, may be positioned between the first bypass leg 358A and the second bypass leg 358B.

[0198] Loop inlet tube 108B may be coupled to second cassette port 360B and may connect soft cassette 340 to flexible circuit 524. Loop inlet tube 108B may also include a sensor 808 located on or in tube 108B that is positioned with tube 108B before connecting to system static connector 528 of the flexible circuit 524. The pressure sensor (CPS) 808 may detect one or more of, but not limited to: pressure, the presence of fluid or air, and/or possibly another characteristic of the fluid in the tube 108B. In addition, the suction pump 208 may cause fluid to be pumped through the tube 108B or from or to the soft cassette 340.

[0199] Two or more different tubes may be coupled to flexible circuit 524 via system static circuit connector 528 and provide fluid to or receive fluid from blood component collection reservoir 536. Loop outlet tube 112 extends from system static loop connector 528 from flexible loop 524. This loop outlet tube 112 may also include another linear sensor 812 placed on or in it to detect fluid, air, cell concentration, color, and /or a color change in the fluid coming from the flexible circuit 524; linear sensor 812 may be the same or similar in type and/or function to sensors 804, 312, 320, 808 and/or 284 described previously. A second CPS sensor 816 or fluid sensor may also be placed in or on line 112. Sensor 816 may detect one or more of, but not limited to, the presence or absence of fluid, pressure in tube 112, and/or other characteristic of fluid in tube 112. Likewise, sensor 816 may be the same or similar in type and/or function to sensors 804, 312, 320, 808, 812 and/or 284 described previously.

[0200] Loop outlet tube 112 can then flow into plasma air detection sensor 284 before the saline and plasma tube y-connector 280 separates tube 112 into saline tube 116 and plasma tube 120. The return pump 212 may interact with the circuit outlet tube 112 and may cause fluid or air to flow through the tube 112 from the flexible circuit 524 or from the saline bag 118 and/or plasma collection bottle 122 .

[0201] The saline bag 118 and associated tubing may be as previously described and may provide saline solution through the system 200 back to the donor 102. The saline flow control valve 288 may isolate the saline bag 118 from the rest of the system 200. In addition, the bottle The plasma collection 122 may receive plasma from the flexible circuit 524 when processed or separated from whole blood. The plasma collection bottle 122 can be selectively isolated from the system by means of a plasma flow control valve 286 .

[0202] An embodiment of the electrical and control system 900 that controls the functions of the apheresis system 200 may be as shown in FIG. 9, in accordance with embodiments of the present disclosure. The control system 900 may include one or more components, 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.

[0203] Each node may operate to control a different portion of the apheresis system 200. For example, the control system 900 may include a cassette assembly 904 and a centrifuge assembly 908, which may control or communicate with components of the blood component collection kit 500 (and associated hardware or mechanical components interfaced with the soft cassette assembly 300) and the assembly assembly 400 centrifuge (and associated hardware or mechanical components associated therewith), respectively. The cassette assembly 904 and the centrifuge assembly 908 may be in communication wirelessly or through some other electrical or data connection. In some configurations, the individual nodes 904, 908 may be two parts of a single node 902. Essentially, each node 904, 908 may have the same physical hardware operating to control different functions. An example of a cassette assembly 904 may be that described in connection with FIG. 10; The centrifuge assembly 908 may be as described in connection with FIG. eleven.

[0204] Each of the nodes 904, 908 may be in communication with one or more sensors 916, 920 and/or 924. There may be more or fewer sensors than those illustrated in FIG. 9, as represented by ellipsis 928. Each node 904, 908 may be in direct communication with each sensor 916-924 or may be in communication with multiple sensors 916-924 via bus 912. Bus 912 may communicate via any type of communication protocol such such as Universal Serial Bus (USB), Universal Asynchronous Receive/Transmit (UART), or other types of bus systems or parallel communication connections. Thus, bus 912 may be optional, but is shown as a possible communication platform for communicating with various sensors 916-924. Sensors 916-924 may be any type of sensor that can transmit information about light, fluid, presence of air, color, pressure, etc., as disclosed herein. Some of the sensors 916-924 may include sensors 312, 316, 804, 808, 812, 816 and/or 284. The function of these sensors 912-924 may be as further disclosed herein.

[0205] The nodes 904, 908 may also communicate with one or more pump drives, pump motors, etc. 936, 940, 944, simply referred to as “pumps.” There may be more or fewer pumps than shown in FIG. 9, as represented by ellipsis 948. Nodes 904, 908 may communicate with pumps 936-944 through direct wired or wireless communications or through bus 932. Bus 932 may be a control local area network (CAN) bus, USB, or other type of bus architecture for in order to communicate with pumps 936–944. Pumps 936-944 may include pumps 216, 208 and/or 212, as previously described. The function of pumps 936-944 may be as described herein.

[0206] An embodiment of the cartridge assembly 904 may be as shown in FIG. 10 in accordance with embodiments of the present disclosure. The cartridge assembly 904 may include one or more of a controller 1004, a memory 1008, a valve controller 1020, and/or communication interfaces for a CAN bus 1016, a UART 1012, or other types of buses. The cartridge assembly 904 may contain other hardware, firmware, and/or software that is not shown for transparency.

[0207] Controller 1004 may be a microcontroller, microprocessor, field programmable gate array (FPGA), application specific integrated circuit (ASIC) of any type, etc. An exemplary 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 are possible. The controller 1004 may control other types of devices or control the functions of other types of devices, such as valves 320A, 320B, 320C, 286, 288, pumps 936-944, etc. In addition, the controller 1004 may communicate with various sensors 916-924 or other devices to receive or send information regarding the function of the apheresis system 200.

[0208] Other examples of processors or microcontrollers 1004 as disclosed herein may include, but are not limited to, at least one of 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 coprocessors, Samsung® Exynos® series, Intel® Core™ processor family, Intel® Xeon® processor family, Intel® Atom™ processor family, Intel processor family Itanium®, Intel® Core® i5-4670K and i7-4770K 22 nm Haswell, Intel® Core® i5-3570K 22 nm Ivy Bridge, AMD® FX™ Processor Family, AMD® FX-4300, FX-6300 and FX-8350 32 nm Vishera, AMD® Kaveri processors, ARM® Cortex™–M processors, ARM® Cortex–A and ARM926EJ–S™ processors, other industry equivalent processors and can perform computing functions using any known or future developed standard, set of instructions, libraries and/or architecture.

[0209] Memory 1008 may be any type of memory, including random access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), compact disc read-only memory (CD-ROM), optical a storage device, a magnetic storage device, any suitable combination of the above or another type of storage or memory device that stores and provides instructions for programming and operating the controller 1004. The memory 1008 may include any type of software or firmware that programs the functions of the controller 1004, as further disclosed hereinafter.

[0210] The controller 1004 may communicate with one or more valve controllers 1020. Each valve 320A, 320B, 320C, 286, 288, as disclosed herein, can be controlled by a valve controller 1020 and can be associated with a component of the system 200, as disclosed herein. Valve controller 1020 may provide an electrical signal, operating directive, or power to close or open any one of the valves described herein, e.g., saline and plasma valve body 276, plasma flow control valve 286, saline flow control valve 288 solution, first fluid control valve 320A, first fluid control valve 320A and/or outlet fluid control valve 320C, etc.

[0211] Controller 1004 may also be coupled to bus 912, 932 (e.g., UART bus, CAN bus), or other buses through transceivers 1012, 1016 provided external to controller 1004 or built into controller 1004. UART transceiver 1012 may communicate with one or more more sensors 916–924 or other devices. Likewise, the CAN bus transceiver 1016 may communicate with one or more of the pump controllers 936-944 or other devices. UART transceivers 1012 and buses and CAN bus transceivers 1016 are well known in the art and do not need further explanation herein.

[0212] An embodiment of centrifuge assembly 908 may be as shown in FIG. 11, in accordance with embodiments of the present disclosure. The centrifuge assembly 908 may contain the same or similar types of components as the cassette assembly 904. For example, centrifuge assembly 908 may include a controller 1104, a UART transceiver 1112, etc. Like controller 1004, controller 1104 may be any type of processor or microcontroller, such as the NK10DN512VOK10 microcontroller unit with 32-bit architecture from N9P USA, Incorporated, as noted previously, or other controllers, processors, etc., such as devices noted previously.

[0213] The controller 1104 may communicate with the sensors 916-924 directly, through the UART transceiver 1112, or through other buses or systems. The controller 1104 may also communicate with a brake controller 1124, which may brake or slow down and stop the centrifuge 400. Likewise, the controller 1104 may communicate with an engine transceiver 1116, which communicates with an engine power system or engine controller that operates to to spin or rotate the centrifuge 400 or control speed settings or other function of the centrifuge 400.

[0214] In some configurations, controller 1104 may also communicate with cuff controller 1122, which may change or set pressure in the pressure cuff on the donor's arm during the apheresis process. In addition, the controller 1104 may communicate with and/or control the strobe light source 1112, which may be any light that flashes at regular intervals in synchronization with the rotation speed of the motor, so that the operator of the apheresis system 200 can see the operation of the filler 460, as described. previously. Thus, the controller 1104 may communicate with the strobe light source 1112 to change the blinking frequency of the strobe light source 1112, the intensity of the strobe light source 1112, etc.

[0215] Embodiments of method 1200 used to perform apheresis of blood components (eg, plasma) using system 200 may be as shown in FIG. 12, in accordance with embodiments of the present disclosure. Method 1200 may be described in conjunction with FIG. 17A–17T. As such, method 1200 is described in connection with or with reference to these FIGS. The general order of steps of method 1200 is presented in FIG. 12. Typically, method 1200 begins with an initial operation 1204 and ends with operation 1220. Method 1200 may include more or fewer steps or may have a different order of steps than that shown in FIG. 12. Method 1200 may be, at least in part, implemented as a set of computer-executable instructions that are executed by a computer system, processor, cassette microcontroller 1004, centrifuge microcontroller 1104, and/or other device, and encoded or stored in a machine-readable medium. In other configurations, method 1200 may be implemented, at least in part, through a series of components, circuits, gates, etc., created in a hardware device, such as a system on a chip (SOC), an application specific integrated circuit (ASIC), and/or field programmable gate array (FPGA). Hereinafter, the method 1200 is explained with reference to the systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal processes, models, environments, apheresis systems, etc., described in combination with fig. 1–11.

[0216] The method 1200 can be generally divided into three phases, where each phase includes a series of steps or processes. Each of the three phases is described in FIG. 12 and with reference to FIG. 13–16, where the steps or processes are described. The method 1200 may include a system preparation phase, at step 1208. In this phase 1208, the operator may prepare the system 200 for apheresis, which may include the steps of placing a needle in the donor 102, performing other operations to prepare for blood absorption, installing a blood component collection kit 500 into the system, etc. An example of steps that may be included in the preparation phase of system 1208 may be those described in connection with FIG. 13.

[0217] Method 1200 may then enter a plasma aspiration phase at step 1212. The plasma aspiration phase 1212 may be as described in connection with FIG. 14. The plasma absorption phase 1212 may include sucking blood, centrifuging the blood to extract the plasma (and/or other blood components), pushing high hematocrit blood (eg, red blood cells) and/or other blood components back to the donor 102 various return cycles (until a complete sample of plasma and/or other blood component is collected), etc. The initiation of return cycles can be triggered based on the presence, at some predetermined position in the apheresis system, of one or more blood components, such as platelets, red blood cells, etc.

[0218] The final phase of method 1200 may be a disposable agent unloading phase, at step 1216. The disposable agent unloading phase 1216 can be described in conjunction with FIG. 15. The unloading phase of the disposable agent 1216 may include completing the apheresis process, removing the needle from the donor 102, unloading the blood component collection kit 500, and completing the procedure. Each of the three phases 1208-1216 and the steps or process associated therewith are described below.

[0219] The method for preparing the apheresis system 200, as described in phase 1208, may be as shown in FIG. 13, in accordance with embodiments of the present disclosure. The general order of steps of method 1300 is presented in FIG. 13. Typically, method 1300 begins with an initial operation 1304 and ends with operation 1328. Method 1300 may include more or fewer steps or may have a different order of steps than that shown in FIG. 13. Method 1300 may be, at least in part, implemented as a set of computer-executable instructions executed by a computer system, processor, cassette microcontroller 1004, centrifuge microcontroller 1104, and/or other devices and executable or stored in a machine-readable environment. In other configurations, method 1300 may be implemented, at least in part, through a series of components, circuits, gates, etc., created in a hardware device such as a SOC, ASIC, and/or FPGA. Hereinafter, method 1300 is explained with reference to systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal processes, models, environments, apheresis systems, methods, etc. ., described in conjunction with FIGS. 1–12.

[0220] The user or operator may load the blood component collection kit 500 at step 1308. At this step 1308, the user may load the blood component collection kit 500 into the system 200, including inserting the flexible circuit 524 into the circuit holding bracket 426 and a reservoir 536 for collecting blood components into a filler 460 (both may be as described in FIG. 16). Additionally, the soft cassette 340 may be installed in the soft cassette assembly 300, as described in connection with FIG. 1, 2A, 2B, 3A and/or 3B. The circuit inlet tube 108B may be inserted into the leading tube guide 244 and/or the end tube guide 252 into the suction pump 208 to cause fluid movement in the circuit inlet tube 108B and other parts of the blood component collection set 500. Likewise, the anticoagulant tube 110 may be placed in guide tubes similar to the guides 244, 252 to allow the AC pump 216 to move the anticoagulant into the anticoagulant tube 110 or other portions of the blood component collection kit 500. The circuit outlet tube 112 may be inserted into similar guides 244, 252 to allow the return pump 212 to move blood components (e.g., plasma) into the plasma collection bottle 122 or to move saline solution from the saline bag 118 to the circuit outlet tube 112 or other parts of the kit. 500 for collection of blood components.

[0221] As shown in FIG. The 2D, y-connector 280 of saline and plasma tubing may be installed in the plasma and saline valve control system 228 to allow valves 286, 288 to control the flow of fluid from and/or into the plasma collection bottle 122 and/or saline bag 118 AC bag 114 may be mounted on anticoagulant support 232A, plasma collection bottle 122 may be placed on plasma collection frame 232C, and saline bag 118 may be mounted on saline support 232B as described in FIG. 1–2B. With the blood component collection kit 500 installed in the apheresis system 200, the apheresis system 200 may appear as shown in FIG. 17A and 17B. The state of the various components of the apheresis system 200, during this stage, may be as follows:

Set loading status Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 0 No Return pump 212 0 No Anticoagulant pump 216 0 Plasma flow control valve 286 Open Brine flow control valve 288 Open First fluid control valve 320A Open Second fluid control valve 320B Open Fluid Control Release Valve 320C Open Filler 460 0

Table 1: Set download status

As shown in the above table and subsequent tables, the suction pump 208 and the return pump 212 may overlap the circuit inlet tube 108B and the anticoagulant tube 110, respectively. Thus, suction pump 208 and return pump 212 function as “valves” that selectively allow or inhibit fluid flow. The minus sign “–” in the “Flow Rate” column indicates that the pump rotates counterclockwise. The abbreviation "AF" stands for "auto flow" and indicates that the pump operates at the blood flow rate coming from donor 102. This AF flow rate does not allow the apheresis system 200 to siphon blood from donor 102 or return blood flow to donor 102 and/or AF optimizes the rates suction and return flows, while improving donor safety.

[0222] The saline bag 118 can be pierced, at step 1312. The user can remove any protective coating from the bag piercing fitting 512, at the distal end of the saline tube 116, to pierce the saline bag 118, which contains the saline solution. In other configurations, the saline tube 116 may be mechanically attached to the saline bag 118 (eg, via a luer lock), and the user may modify a frangible device or other removable barrier to allow the flow of saline solution from the saline bag 118. Thus, piercing the saline bag 118 allows saline to flow into blood component collection kit 500 to or through saline flow control valve 288 . The state of the various components of the apheresis system 200, during this stage, may be as follows:

Saline puncture condition Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 0 No Return pump 212 0 Yes Anticoagulant pump 216 0 Plasma flow control valve 286 Closed Brine flow control valve 288 Closed First fluid control valve 320A Open Second fluid control valve 320B Open Fluid Control Release Valve 320C Open Filler 460 0

Table 2: Saline puncture status

[0223] At step 1316, brine 1712 is loaded. The brine load 1712 activates the cassette microcontroller 1004, which controls the opening of the brine flow control valve 288, as shown in FIG. 17D. The cassette microcontroller 1004 may receive instructions for a user interface or program to begin the apheresis process, which begins by loading saline solution 1712. Thus, saline solution 1712 is moved from the saline bag 118, through the saline flow control valve 288 to the air detection sensor 284 in plasma. The cassette microcontroller 1004 controls counterclockwise rotation of the return pump 212 to cause a volumetric flow of saline solution 1712 from the saline bag 118 and through the saline tube 116 and y-connector 280 of the saline and plasma tubes installed in the plasma and saline valve control system 228 , to the plasma air detection sensor 284 . After the plasma air detection sensor 284 detects either the presence of liquid or the absence of air in the circuit outlet tube 112, a signal is sent to the cartridge microcontroller 1004. The cassette microcontroller 1004 can then control the return pump 212 to stop rotation and control the saline flow control valve 288 to close it, which prevents further saline solution 1712 from entering the circuit outlet tube 112 substantially downstream of the plasma air detection sensor 284. At this point in the process, the apheresis system may look like that shown in FIG. 17E. The state of the various components of the apheresis system 200, during this stage, may be as follows:

Brine loading status Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 0 No Return pump 212 -10 Yes Anticoagulant pump 216 0 Plasma flow control valve 286 Closed Brine flow control valve 288 Open First fluid control valve 320A Open Second fluid control valve 320B Open Fluid Control Release Valve 320C Open Filler 460 0

Table 3: Brine loading status

[0224] It should be noted that the return pump 212 is described as rotating counterclockwise. This direction of rotation is associated with the location of the return pump 212 relative to the circuit outlet conduit 112. If a return pump 212 is installed with a circuit outlet tube 112 below the return pump 212, the return pump 212 will rotate in a clockwise direction to move the saline solution 1712 from the saline bag 118. Thus, throughout this description, the direction of rotation of the pump is described. for return pump 212, suction pump 208 and/or AC pump 216, but these directions of rotation may be different if pumps 208, 212, 216 are mounted or positioned differently. In addition, other types of pumps can be used, which will change the operation of the pumps in order to move different liquids or air in the system 200. One skilled in the art will understand how to make these modifications to achieve similar results, as described in the following processes and steps .

[0225] In addition, the volumes moved and the speeds of movement in the apheresis system 200 are indicated or described in the tables that are included in the present description. However, these volumes and rates depend on the size of the tubing, the size of the bags used, the desired volume of blood component collected (eg, 880 mL of plasma), and other considerations. Federal and state laws and other guidelines may determine the volumes and rates used in the apheresis system 200, or these displacement volumes and rates of motion may be predetermined based on the direction of a health care professional or based on the characteristics of the donor 102. As such, the displacement volumes and rates of motion are are only exemplary, but a person skilled in the art knows what transport volumes and movement speeds to set for the following stages and processes.

[0226] Hereinafter, the anticoagulant (AC) 1702 may be pierced at step 1320. The anticoagulant 1702 may be pierced in a process similar to the saline solution 1712. For example, the user may attach the conduit fitting 508 to the AC bag 114. The user then may break frangible, open a valve or other device, or modify some structure that will allow AC 1702 to flow into anticoagulant tube 110. In other configurations, the user may insert a needle into the AC bag 114. At this point in the process, the apheresis system 200 may appear as shown in FIG. 17E. The cassette microcontroller 1004 may receive a signal from the user, through a user interface or other user input device, that the AC bag 114 is connected or pierced. The state of the various components of the apheresis system 200, during this stage, may be as follows:

Anticoagulant puncture state Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 0 No Return pump 212 0 Yes Anticoagulant pump 216 0 Plasma flow control valve 286 Closed Brine flow control valve 288 Closed First fluid control valve 320A Open Second fluid control valve 320B Open Fluid Control Release Valve 320C Open Filler 460 0

Table 4: Anticoagulant puncture status

[0227] Then, in response to a signal from the user, the cassette microcontroller 1004 may load the AC 1702, at step 1324. To load the AC 1702, the cassette microcontroller 1004 may control the AC pump 216 to operate or rotate in a clockwise direction to pump anticoagulant 1702 from AC bag 114 into anticoagulant tube 110 as shown in FIG. 17F and 17G. The donor delivery tube 104 may be blocked using a clamp, frangible device, or other structure. Thus, AC 1702 does not flow from donor supply tube 104 to donor 102. Rather, AC pump 216 may push anticoagulant 1702 into cassette inlet tube 108A, into soft cassette 340, and partially into circuit inlet tube 108B. In embodiments, AC 1702 flows through first bypass leg 358A, second bypass leg 358B, and/or fluid sensor 316, but not necessarily into first tubing section 368A or second tubing section 368B. Thus, the cartridge microcontroller 1004 may close the first fluid control valve 320A to prevent AC 1702 from flowing into the first tube section 368A, the drip chamber 354, or the second tube section 368B. Prepositioning AC 1702 in first bypass leg 358A, second bypass leg 358B, and/or fluid sensor 316 ensures proper flow of whole blood during the first aspiration of whole blood from donor 102 and prevents a large volume of AC 1702 from returning to donor 102 from drip chamber 354 when red blood cells are returned later in the process.

[0228] In order to determine when to stop the AC pump 216, the cassette microcontroller 1004 may receive signals from the fluid sensor 316 and/or the donor air detection sensor 312 that indicate that fluid is in or passing through the sensors 312, 316. When fluid sensor 316 provides an indication to cartridge microcontroller 1004 that AC 1702 has reached sensor 316, cartridge microcontroller 1004 may continue to drive AC pump 216 for a predetermined period of time until a known volume of AC 1702 is pumped through second cartridge port 360B. and partially into circuit inlet tube 108B. Thus, loading AC 1702 puts the apheresis system 200 in a state as shown in FIG. 17G. The state of the various components of the apheresis system 200, during this stage, may be as follows:

Anticoagulant loading status Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 0 No Return pump 212 0 Yes Anticoagulant pump 216 thirty Plasma flow control valve 286 Closed Brine flow control valve 288 Closed First fluid control valve 320A Closed Second fluid control valve 320B Closed Fluid Control Release Valve 320C Open Filler 460 0

Table 5: Anticoagulant loading status

[0229] In some configurations, the AC direction of pump 216 can be reversed, as shown in FIG. 17G. At least a portion of the anticoagulant 1702 can then be pumped back into the AC bag 114 and/or into a portion of the cartridge inlet tube 108A and/or the anticoagulant tube 110. In certain embodiments, the cartridge microcontroller 1004 may control the fluid control outlet valve 320C to close it to maintain AC in the first bypass leg 358A, the second bypass leg 358B, and/or the fluid sensor 316. The donor air detection sensor 312 may detect when the AC 1702 stops passing the sensor 312 and send a signal to the cartridge microcontroller 1004 . Again, the cartridge microcontroller 1004 may continue to control the AC pump 216 for a predetermined period of time until a known volume of AC 1702 is pumped back through the cartridge inlet tube 108A. Thus, AC 1702 leaves the apheresis system 200 in the state as shown in FIG. 17H. The amount of anticoagulant remaining in the cartridge inlet tube 108A, tubing connector 106, and/or anticoagulant tube 110 can be determined by the cartridge microcontroller 1004 by the number of times and after the anticoagulant 1702 has passed the donor air detection sensor 312. This process leaves some anticoagulant in the cassette inlet tube 108A, but reduces the amount of AC used to prevent problems of too much AC mixing with the incoming whole blood. At this point, the apheresis system 200 is prepared and ready to absorb whole blood in phase 1212 (FIG. 12). The state of the various components of the apheresis system 200, during this stage, may be as follows:

AC filling end state Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 0 No Return pump 212 0 No Anticoagulant pump 216 -thirty Plasma flow control valve 286 Closed Brine flow control valve 288 Closed First fluid control valve 320A Open Second fluid control valve 320B Open Fluid Control Release Valve 320C Closed Filler 460 0

Table 6: AC filling end state

[0230] An embodiment of method 1400 representing plasma absorption phase 1212 may be as shown in FIG. 14 in accordance with embodiments of the present disclosure. The general order of steps of method 1400 is presented in FIG. 14. Typically, method 1400 begins with an initial operation 1404 and ends with operation 1440. Method 1400 may include more or fewer steps or may have a different order of steps than that shown in FIG. 14. Method 1400 may be, at least in part, implemented as a set of computer-executable instructions executed by a computer system, processor, cassette microcontroller 1004, centrifuge microcontroller 1104, and/or other devices and executable or stored in a machine-readable environment. In other configurations, method 1400 may be implemented, at least in part, using a series of components, circuits, gates, etc., created in a hardware device such as a SOC, ASIC, and/or FPGA. Hereinafter, method 1400 is explained with reference to systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal processes, models, environments, apheresis systems, methods, etc. ., described in conjunction with FIGS. 1–13.

[0231] At step 1408, donor 102 can be pierced with a needle. A phlebotomist, apheresis technician, or other healthcare professional may attach a needle having a lumen to tubing fitting 504 and place the needle into a blood vessel (e.g., vein) of donor 102. Thus, apheresis system 200 may be fluidly coupled to donor 102 and prepared for absorption of whole blood. Thus, the apheresis system 200 begins the plasma absorption phase 1212 in a state where the donor 102 is ready to provide whole blood, as shown in FIG. 17H. The state of the various components of the apheresis system 200, during this stage, may be as follows:

Donor piercing status Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 0 Yes Return pump 212 0 Yes Anticoagulant pump 216 0 Plasma flow control valve 286 Closed Brine flow control valve 288 Closed First fluid control valve 320A Closed Second fluid control valve 320B Closed Fluid Control Release Valve 320C Closed Filler 460 0

Table 7: Donor Piercing Status

[0232] The cartridge microcontroller 1004 of the apheresis system 200 may begin to suction whole blood 1706, at step 1412. The cartridge microcontroller 1004 may control the AC pump 216, suction pump 208, and/or return pump 212 to operate by clockwise rotation. AC pump 216 pushes anticoagulant 1702 toward plasma collection bottle 122 to mix AC 1702 with whole blood 1706 sucked from donor 102 in tubing connector 106 (and possibly in donor supply tube 104) and other components distal to tubing connector 106. Suction pump 208 and/or return pump 212 draw whole blood 1706 from donor 102 (and AC) into soft cassette 340, flexible circuit 524, and/or blood component collection reservoir 536. During this process 1412, the cassette microcontroller 1004 and the centrifuge microcontroller 1008 may communicate to inform the centrifuge microcontroller 1008 that suction has begun. In response to an indication that suction has begun, the centrifuge microcontroller 1008 may control the rotor and motor assembly 414 of the centrifuge assembly 400 to begin spinning or turning. The initial rotation speed may be lower to allow the blood component collection reservoir 536 to seat in the filler insert chamber 492 and draw whole blood 1706 into the blood component collection reservoir 536 . The state of the apheresis system 200, during this step 1412, may look like FIG. 17I. The state of the various components of the apheresis system 200, during this stage, may be as follows:

Suction start state Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 A.F. Yes Return pump 212 (AF+50) Yes Anticoagulant pump 216 AF/15 Plasma flow control valve 286 Open Brine flow control valve 288 Closed First fluid control valve 320A Open Second fluid control valve 320B Open Fluid Control Release Valve 320C Closed Filler 460 800

Table 8: Suction Start Status

[0233] At step 1416, the areas of the blood component collection reservoir 536 adjacent the channel inlet 468, the channel end 472 and/or the channel path break 476 are filled with whole blood 1706. The cassette microcontroller 1004 stops the operation of the return pump 212, but continues the operation of the AC pump 216 and a suction pump 208. Whole blood 1706 is pushed through the first tubing section 368A, the drip chamber 354, and/or the second tubing section 368B. From the soft cassette 340, whole blood 1706 is pushed through the flexible circuit 524 and into the blood component collection reservoir 536 to the free end 540B of the reservoir. The anticoagulant pump 216 continues to operate to mix the anticoagulant 1702 from the anticoagulant bag 114 with the whole blood 1706 sucked from the donor 102. The apheresis system 200 may look like that shown in FIG. 17J during step 1416. The state of the various components of the apheresis system 200, during this step, may be as follows:

Channel Fill Status Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 A.F. Yes Return pump 212 0 Yes Anticoagulant pump 216 AF/15 Plasma flow control valve 286 Open Brine flow control valve 288 Closed First fluid control valve 320A Open Second fluid control valve 320B Open Fluid Control Release Valve 320C Closed Filler 460 3200

Table 9: Channel Fill Status

[0234] Additional communication is provided between the cassette microcontroller 1004 and the centrifuge microcontroller 1008 to indicate channel fullness. In response to this communication, the centrifuge microcontroller 1008 controls the rotor and motor assembly 414 of the centrifuge assembly 400 to begin spinning or turning at higher revolutions per minute (RPM).

[0235] Next, with reference to step 1420, the cartridge microcontroller 1004 begins to perform a first aspiration of plasma 1704 or other blood component from the whole blood 1706. The cartridge microcontroller 1004 continues to drive the AC pump 216 to provide the anticoagulant 1702 into the cartridge inlet tube 108A. to mix with whole blood 1706 from donor 102. In addition, the cassette microcontroller 1004 continues to drive the suction pump 208 to move the whole blood 1706 to the blood component collection reservoir 536 to separate the plasma 1704 from the whole blood 1706. In order to achieve separation of the plasma 1704, the cassette microcontroller 1004 informs the centrifuge microcontroller 1008 that the suction step has begun. In response to this communication, the centrifuge microcontroller 1008 controls the rotor and motor assembly 414 of the centrifuge assembly 400 to begin spinning or turning at even higher revolutions per minute (RPM), such as substantially 5000 RPM. to begin separating red blood cells 1708 from plasma 1704, as shown in FIG. 17K. Suction pump 208 continues to push plasma 1704 through flexible circuit 524, system static circuit connector 528, and into circuit outlet tube 112. The suction process 1420 continues until, at some point, as shown in FIG. 17L, platelets 1710 separated from whole blood 1706 do not reach the linear sensor 812, which signals the cassette microcontroller 1004 that the total amount of plasma 1704 has been extracted from the whole blood 1706, which is pushed into the blood component collection reservoir 536, and the cassette microcontroller 1004 proceeds to step 1424. The state of the various components of the apheresis system 200, during this step, may be as shown below:

Suction state Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 A.F. Yes Return pump 212 0 No Anticoagulant pump 216 AF/15 Plasma flow control valve 286 Open Brine flow control valve 288 Closed First fluid control valve 320A Closed Second fluid control valve 320B Closed Fluid Control Release Valve 320C Open Filler 460 5000

Table 10: Suction status

[0236] When platelets 1710, red blood cells, high hematocrit blood, and/or other blood component reach the linear sensor 812, as determined by the sensor 812 by observing a change in color or other characteristic of the fluid, the cassette microcontroller 1004 then determines whether the cartridge is complete or not. delivery, at step 1426. Complete delivery means that the required or desired total amount of plasma 1704 is aspirated and placed in the plasma collection bottle 122. In certain embodiments, the cassette microcontroller 1004 may determine whether a full change (eg, 880 ml) has been removed by weight or volume. This situation may be as shown in FIG. 17L, where the plasma 1704 is recovered and still present in the circuit outlet tube 112 and provided to the plasma collection bottle 122 through the plasma tube 120. If it is an incomplete delivery, meaning that the plasma collection bottle 122 has not reached its desired mass or volume limit, process 1400 may proceed to NO and return to step 1428. If it is a complete delivery, method 1400 may proceed to YES and final stage 1432 return.

[0237] At return step 1428, as depicted in FIG. 17L, the cassette microcontroller 1004 instructs the suction pump 208 to stop and reverse the direction of the return pump 212 to move counterclockwise to push the plasma 1704 from the plasma collection bottle 122 through the plasma tube 120, into the circuit outlet tube 112 and to the soft cassette 340. The microcontroller The cassette 1004 further controls the outlet fluid control valve 320C to close and open both the first fluid control valve 320A and the second fluid control valve 320B. These configuration changes cause the plasma 1704 to push the red blood cells 1708 and platelets 1710 from the circuit exit tube 112, the flexible circuit 524, the blood component collection reservoir 536, through the drip chamber 354 and to the donor 102. Importantly, as can be seen in FIG. 17L, the filler 460 continues to rotate at the extraction speed, for example, 5000 rpm, during this return stage 1428. System 200 continues to push red blood cells 1708 back toward donor 102 until color/pressure sensor 808 determines that plasma 1704 has passed through sensor 808 and can reach drip chamber 354, as shown in FIG. 17M. At this point, valves 320B and 320A close again and whole blood 1706 can flow again through first bypass leg 358A, second bypass leg 358B, and/or fluid sensor 316. The state of the various components of the apheresis system 200, during this step 1428, may be as follows:

Return Status Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 0 No Return pump 212 A.F. Yes Anticoagulant pump 216 0 Plasma flow control valve 286 Open Brine flow control valve 288 Closed First fluid control valve 320A Open Second fluid control valve 320B Open Fluid Control Release Valve 320C Closed Filler 460 5000

Table 11: Return Status

[0238] The return stage 1428 then proceeds to the second suction stage 1420 . The new absorption proceeds similarly to step 1420 described above. However, there is a section of high hematocrit blood that remains in the drip chamber 354. By moving a new stream of whole blood 1706 through first bypass leg 358A, second bypass leg 358B, and/or fluid sensor 316, less high hematocrit blood is returned to reservoir 536 to collect blood components, no more plasma 1704 can be extracted from these red blood cells. Thus, the bypass provided by the soft cassette 340 makes removal of plasma 1704 from whole blood 1706 in the second absorption stage 1420 and subsequent absorption stages more efficient.

[0239] The return step 1428 and the continued suction step 1420 are repeated for a number of cycles. The final suction stage 1420 may be as shown in FIG. 17N. The plasma 1704, in the plasma collection bottle 122, has reached the desired and/or maximum amount, for example, 880 ml, as shown in FIG. 17N. At this point, a final return is required, at step 1432. The state of the various components of the apheresis system 200, during this return step, may be as shown below:

Final Return State Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 0 No Return pump 212 A.F. Yes Anticoagulant pump 216 0 Plasma flow control valve 286 Closed Brine flow control valve 288 Open First fluid control valve 320A Open Second fluid control valve 320B Open Fluid Control Release Valve 320C Closed Filler 460 5000

Table 12: Final Return Status

[0240] At step 1432, the total amount of plasma 1704 recovered from donor 102 is now in the plasma collection bottle 122, and the apheresis system 200 can now push the remaining plasma 1704, red blood cells 1708, and any other blood component into the donor 102. Microcontroller 1004 The cassette may instruct the plasma flow control valve 286 to close to hold the plasma donation in the plasma collection bottle 122 . The return pump 212 may continue to operate while rotating counterclockwise to push the red blood cells 1708 and any plasma 1704 or other blood components back to the donor 102.

[0241] Following or as part of the final return 1432, the saline solution 1712 may also be returned to the donor 102, as shown in FIG. 17O, at step 1436. At this step 1436, the cartridge microcontroller 1004 opens the brine flow control valve 288 and leaves the first fluid control valve 320A and the second fluid control valve 320A open. The return pump 212 continues to operate in a counterclockwise direction. The centrifuge microcontroller 1008 stops the rotation of the filler 460. The saline solution 1712 from the saline bag 118 is pushed through the blood component collection reservoir 536, the drip chamber 354, and the various tubes back to the donor 102. The various blood components remaining in the blood component collection set 500 are pushed back to donor 102 along with some saline solution 1712. Saline solution 1712 helps replenish fluids in donor 102 and is required in some jurisdictions. This return of saline solution 1712 continues until a predetermined amount of saline solution 1712 is provided to the user, as determined by the weight or volume of saline solution 1712 that has left the saline bag 118. At this point, as shown in FIG. 17O, plasma donation completed. The state of the various components of the apheresis system 200, during this stage, may be as follows:

Brine return status Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 0 No Return pump 212 AF (300) Yes Anticoagulant pump 216 0 Plasma flow control valve 286 Closed Brine flow control valve 288 Open First fluid control valve 320A Open Second fluid control valve 320B Open Fluid Control Release Valve 320C Open Filler 460 0

Table 13: Brine Return Status

[0242] An embodiment of the plasma unloading method and blood component collection kit 500 from the apheresis system 200, as described in unloading phase 1216, may be as shown in FIG. 15, in accordance with embodiments of the present disclosure. The general order of steps of method 1500 is presented in FIG. 15. Typically, method 1500 begins with an initial operation 1504 and ends with operation 1528. Method 1500 may include more or fewer steps or may have a different order of steps than that shown in FIG. 15. Method 1500 may be, at least in part, implemented as a set of computer-executable instructions executed by a computer system, processor, cassette microcontroller 1004, centrifuge microcontroller 1104, and/or other devices and executable or stored in a machine-readable environment. In other configurations, method 1500 may be implemented, at least in part, by a series of components, circuits, gates, etc., created in a hardware device such as a SOC, ASIC, and/or FPGA. Hereinafter, method 1500 is explained with reference to systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal processes, models, environments, apheresis systems, methods, etc. ., described in conjunction with FIGS. 1–14.

[0243] The channels are emptied at step 1508. In certain embodiments, the cassette microcontroller 1004 operates the suction pump 208 in a counterclockwise direction to continue to drive the saline solution 1712 substantially entirely from the blood component collection reservoir 536 and the rest of the kit. 500 for collecting blood components, as shown in FIG. 17P. At some point, substantially the total amount of blood components and/or saline 1712 is pushed back towards donor 102, at which point all pumps 216, 208 and 212 stop operating. The fluid control valve 320A, the first fluid control valve 320A, the brine flow control valve 288, and any other valve thereafter can be closed by the cassette microcontroller 1004. At this point, only little or no amount of saline solution 1712 should remain in the blood component collection kit 500. The state of the apheresis system 200 may be as shown in FIG. 17Q. The state of the various components of the apheresis system 200, during this stage, may be as follows:

Channel empty state Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 –AF Yes Return pump 212 0 Yes Anticoagulant pump 216 0 Plasma flow control valve 286 Closed Brine flow control valve 288 Closed First fluid control valve 320A Open Second fluid control valve 320B Open Fluid Control Release Valve 320C Open Filler 460 0

Table 14: Channel Empty Status

[0244] At this point, the blood component collection kit 500 can be sealed, at step 1512, as shown in FIG. 17R. Sealing the blood component collection kit 500 may include clamping a donor supply tube 104 that extends to the donor 102 and sealing the tube by fusion sealing at various locations. The sealing may be a melting of the tubes, since the tubes may be thermoplastic, as shown in FIG. 17R. For example, all of the anticoagulant tube 110, saline tube 116, plasma tube 120 (above the plasma flow control valve 286), and donor supply tube 104 are heat fused to separate AC bag 114, plasma collection bottle 122, saline bag 118, and donor 102 from the rest of the set 500 for collecting blood components. The state of the various components of the apheresis system 200, during this stage, may be as follows:

Set sealing status Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 0 Yes Return pump 212 0 Yes Anticoagulant pump 216 0 Plasma flow control valve 286 Closed Brine flow control valve 288 Closed First fluid control valve 320A Closed Second fluid control valve 320B Closed Fluid Control Release Valve 320C Closed Filler 460 0

Table 15: Kit Sealing Status

[0245] At this point, the needle can be removed from the donor 102, at step 1516, as shown at 17R. The state of the various components of the apheresis system 200, during this stage, may be as follows:

Donor disconnect state Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 0 Yes Return pump 212 0 Yes Anticoagulant pump 216 0 Plasma flow control valve 286 Closed Brine flow control valve 288 Closed First fluid control valve 320A Closed Second fluid control valve 320B Closed Fluid Control Release Valve 320C Closed Filler 460 0

Table 16: Donor disconnect status

[0246] The blood component collection kit 500 may be unloaded from the apheresis system 200 at step 1520, thereby reversing at least some of the procedures described in conjunction with FIG. 13 and 16. The status of the various components of the apheresis system 200, during this stage, may be as follows:

Upload status Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 0 No Return pump 212 0 No Anticoagulant pump 216 0 Plasma flow control valve 286 Open Brine flow control valve 288 Open First fluid control valve 320A Open Second fluid control valve 320B Open Fluid Control Release Valve 320C Open Filler 460 0

Table 17: Upload Status

[0247] Once unloaded, the used blood component collection kit 500 can be disposed of as medical waste. The plasma collection bottle 122 may be sealed in the plasma tube 120 as shown in FIG. 17S. The sealed areas can then prevent any liquid from leaking from the plasma collection bottle 122, saline bag 118, or anticoagulant bag 114. The plasma collection bottle 122 can then be removed and used in any procedure where plasma is needed. The remaining items can be discarded as medical waste and the procedure ends at step 1524, as shown in FIG. 17T. The status of the various components of the apheresis system 200, at the end of the procedure, may be as follows:

Procedure completion status Component name Flow rate(ml/min) Is it blocked? Open/closed? Rotation speed (rpm) Suction pump 208 0 No Return pump 212 0 No Anticoagulant pump 216 0 Plasma flow control valve 286 Open Brine flow control valve 288 Open First fluid control valve 320A Open Second fluid control valve 320B Open Fluid Control Release Valve 320C Open Filler 460 0

Table 18: Procedure Completion Status

[0248] An embodiment of a method 1600 for inserting a disposable agent into a fill of the apheresis system 200 may be as shown in FIG. 16, in accordance with embodiments of the present disclosure. The general order of steps of method 1600 is presented in FIG. 16. Typically, method 1600 begins with an initial operation 1604 and ends with operation 1632. Method 1600 may include more or fewer steps or may have a different order of steps than that shown in FIG. 16. Method 1600 may be, at least in part, implemented as a set of computer-executable instructions executed by a computer system, processor, cassette microcontroller 1004, centrifuge microcontroller 1104, and/or other devices and executable or stored in a machine-readable environment. In other configurations, method 1600 may be implemented, at least in part, by a series of components, circuits, gates, etc., created in a hardware device such as a SOC, ASIC, and/or FPGA. Hereinafter, method 1600 is explained with reference to systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signal processes, models, environments, apheresis systems, methods, etc. ., described in conjunction with FIGS. 1–15.

[0249] The filler 460 of the apheresis system 200 may be provided, at step 1608. The filler 460 may be a component of the apheresis system 200 and configured to receive at least a portion of the blood component collection kit 500. In certain embodiments, the filler 460 is mounted on a split housing pivot 406 that is rotated to expose the interior of the upper housing 404B, including the filler 460. The user may rotate the upper housing 404B to expose the collection insert channel 466, or In some embodiments, the infill 460 may be rotated automatically by a motor or other mechanical device. This turning and/or loading may be as described above in connection with FIG. 4D-4F and/or FIG. 6A–6C.

[0250] The blood component collection kit 500, including the blood component collection reservoir 536, may be provided at step 1612. The blood component collection kit 500 may be prepackaged and removed from the packaging. The user can expose the blood component collection reservoir 536 to insert collection inserts into the collection insert channel 466, including ensuring that the free end 540B of the reservoir is positioned at the channel path break 476 in the collection insert channel 466 and the filler circuit connector 532 is positioned in the area 454 circuit connections. When the blood component collection reservoir 536 is properly positioned, the user can shape the blood component collection reservoir 536 to the substantially geometric shape of the collection insert channel 466 and a channel path break 476, at step 1616, as shown in FIG. 5F–5H. Thus, the user can shape the blood component collection reservoir 536 into a generally circular geometric shape or any other geometric shape that generally matches the geometric shape of the collection insert channel 466.

[0251] The user can then insert the formed blood component collection reservoir 536 into the channel 466 of the collection insert 460, as shown in FIG. 5G and 5H, wherein the free end 540B of the reservoir in the blood component collection reservoir 536 is inserted into a channel path break 476 in the collection insert channel 466, at step 1620. The user can insert the blood component collection reservoir 536 into the collection insert channel 466 as a whole. in a central position in the filler insert chamber 492. Centrifugal forces typically place the blood component collection reservoir 536 automatically into the correct position in the filler insert chamber 492. However, if not positioned where centrifugal forces may act on the blood component collection reservoir 536, the blood component collection reservoir 536 may be ejected from the collection insert channel 466. When positioned, the blood component collection reservoir 536 can be locked in place.

[0252] At step 1624, the user may connect the filler circuit connector 532 of the blood component collection reservoir 536 to the circuit connection area 454 of the collection insert channel 466. The user can create a mechanical connection by snapping the core loop connector 532 into the loop connection area 454. The measurements and physical elements of the filler insertion chamber 492 can then hold the blood component collection reservoir 536, with the filler circuit connector 532 stable in the loop connection region 454, in a stable position, allowing the blood component collection reservoir 536 to migrate to the center of the filler insertion chamber 492 in during operation of the centrifuge 400. The portion of the flexible circuit 524 that remains outside or outside the core 460 may be mounted on the circuit pickup lever 416. This setup of flexible circuit 524 allows for 1ω/2ω operation of centrifuge 400.

[0253] Once the flexible circuit 524 is installed, the upper housing 404B may be rotated into position at step 1628. Thus, the filler 460 may be rotated about a hinge axis 406 (e.g., a hinge, etc.) into the interior of the system housing 204. The centrifuge body 404 can then be rotated with the blood component collection circuit 520 passing through the circuit access gap 436 in the split centrifuge body 404. When the blood component collection circuit 520 is loaded at the circuit loading position 520A, a portion of the blood component collection circuit 520 can be partially contained, supported, and/or supported by the circuit holding bracket 426, as described in connection with FIG. 4A–4C. The access panel 224 can be rotated to a closed position, allowing the system 200 to operate.

[0254] Exemplary systems and methods of this disclosure are described with respect to apheresis methods and systems. However, in order not to make the present disclosure unduly confusing, many known structures and devices have been omitted from the foregoing description. This omission should not be construed as limiting the scope of the stated disclosure. Specific details are set forth to provide an understanding of the present disclosure. However, it should be appreciated that the present disclosure may be practiced in a variety of ways beyond the specific details set forth herein.

[0255] In addition, although exemplary aspects, embodiments and/or configurations illustrated herein show various system components co-located, certain system components may be co-located in remote portions of a distributed network such as a LAN and/or the Internet. or in a specialized system. Thus, it should be appreciated that system components may be combined in one or more devices, such as the cassette assembly 904 and the centrifuge assembly 908, or co-located on a specific node in a distributed network, such as an analog and/or digital telecommunications network or switching network. packets or circuit-switched network. From the foregoing description and for reasons of computational efficiency, it should be appreciated that system components can be located at any location in a distributed network of components without affecting the operation of the system. For example, various components may be located in a switch, such as a PBX, and a media server, a gateway, one or more communications devices, one or more user premises, or some combination thereof. Likewise, one or more functional portions of the system may be distributed between the telecommunications device(s) and the associated computing device.

[0256] In addition, it should be appreciated that the various channels connecting the elements may be wired or wireless channels or any combination thereof, or any other known or later developed element(s) that are capable of transmitting and/or communicating data to and from connected elements. These wired or wireless channels may also be secure channels and may be capable of transmitting encrypted information. The transmission media used as channels, for example, can be any suitable carrier for electrical signals, including coaxial cables, copper wire and fiber optics, and can take the form of acoustic or light waves, such as those generated by radio waves or infrared data transmission.

[0257] Also, although flowcharts are discussed and illustrated in relation to a specific sequence of events, it should be appreciated that changes, additions and omissions to this sequence can occur without significantly affecting the operation of the disclosed embodiments, configurations and aspects.

[0258] Many variations and modifications to the disclosure may be used. It is possible to provide some disclosure attributes without providing others.

[0259] In yet another embodiment, the systems and methods of this disclosure may be implemented in combination with a special purpose computer, a programmed microprocessor or microcontroller and peripheral integrated circuit element(s), ASIC or other integrated circuit, digital signal processor, hardware electronics or a logic circuit such as a discrete gate circuit, a programmable logic device or gate array such as a PLD, PLA, FPGA, PAL, a special purpose computer, any comparable means or the like. In general, any device(s) or means capable of implementing the method illustrated herein can be used to implement the various aspects of this disclosure. Exemplary hardware that may be used for the disclosed embodiments, configurations, and aspects includes computers, portable devices, telephones (e.g., cellular, Internet-enabled, digital, analog, hybrid, and others), and other hardware known in the art. . Some of these devices include processors (eg, one or more microprocessors), memory, nonvolatile storage, input devices, and output devices. In addition, alternative software implementations, including, but not limited to, distributed processing or component/object distributed processing, parallel processing, or virtual machine processing, may also be created to implement the methods described herein.

[0260] In yet another embodiment, the disclosed methods can be easily implemented in combination with software using object-based or object-oriented software development environments that provide portable source code that can be used on various computer or workstation platforms. Alternatively, the disclosed system may be implemented in part or in whole in hardware using standard logic circuits or VLSI design. Whether software or hardware is used to implement systems in accordance with this disclosure depends on the speed and/or efficiency requirements of the system, the particular function, and the particular software or hardware systems or microprocessor or microcomputer systems used.

[0261] In yet another embodiment, the disclosed methods may be implemented, in part, in software that may be stored in a storage medium, executed on a programmed general purpose computer in conjunction with a controller and memory, a special purpose computer, a microprocessor, or the like. In these cases, the systems and methods of this disclosure can be implemented as a program embedded on a personal computer, such as an applet, JAVA® script or CGI, as a resource located on a server or computer workstation, as a subroutine embedded in a specialized system measurement, system component or the like. The system may also be implemented by physically embedding the system and/or method into a software and/or hardware system.

[0262] Although the present disclosure describes components and functions implemented in aspects, embodiments and/or configurations with reference to specific standards and protocols, aspects, embodiments and/or configurations are not limited to such standards and protocols. There are other similar standards and protocols not mentioned herein that are considered to be included in this disclosure. In addition, the standards and protocols noted herein and other similar standards and protocols not noted herein are periodically replaced by faster or more efficient equivalents that provide substantially the same functionality. Such replacement standards and protocols having the same functionality are considered equivalent to those included in this disclosure.

[0263] The present disclosure, in various aspects, embodiments and/or configurations, includes components, methods, processes, systems and/or apparatus substantially as depicted and described herein, including various aspects, embodiments, configurations of embodiments, subcombinations thereof and/or subsets. Those skilled in the art will understand how to make and use the disclosed aspects, embodiments and/or configurations after understanding the present disclosure. The present disclosure, in various aspects, embodiments and/or configurations, includes providing devices and processes in the absence of elements not shown and/or described herein, or in various aspects, embodiments and/or configurations thereof, including in the absence such elements as may have been used in previous devices or processes, for example, to improve efficiency, achieve simplicity and/or reduce cost of implementation.

[0264] The above discussion is presented for purposes of illustration and description. The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing detailed description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments and/or configurations for the purpose of streamlining the disclosure. Features of the aspects, embodiments and/or configurations of the disclosure may be combined in alternative aspects, embodiments and/or configurations other than those discussed above. This method of disclosure should not be interpreted as reflecting the notion that claims require more features than are expressly listed in each claim. Rather, as reflected in the following claims, the patentable aspects are contained in less than all of the features of the above disclosed aspect, embodiment and/or configuration. Accordingly, the following claims are hereby incorporated into this detailed description, with each claim standing by itself as a separate preferred embodiment of the disclosure.

[0265] In addition, while the description includes a description of one or more aspects, embodiments and/or configurations and certain variations and modifications, other variations, combinations and modifications are within the scope of the disclosure, for example, as may be within the skill and knowledge of those skilled in the art. this field, after understanding the present disclosure. Intends to be granted rights that include alternative aspects, embodiments and/or configurations to the extent permissible, including alternative, interchangeable and/or equivalent structures, functions, ranges or steps to what is claimed, whether disclosed or not such alternative, interchangeable and/or equivalent structures, functions, ranges or steps in the present description, and without the intention of publicly conveying any patentable subject matter.

Claims (163)

1. A method for collecting a blood component by apheresis, the method includes: absorption of whole blood into a centrifuge from a donor; introducing whole blood into a blood component collection reservoir having an inlet and an outlet, the whole blood being introduced through the inlet, rotating the centrifuge to provide centrifugal force to act on the whole blood to separate the whole blood in the blood component collection reservoir into at least plasma and a blood component containing concentrated red blood cells; separation of plasma from whole blood; extracting plasma through the release of a reservoir to collect blood components into a container; detecting the moment of extraction of red blood cells through release; And, after detecting red blood cells and while the centrifuge continues to rotate, pushing the plasma back into the blood component collection reservoir through the outlet to move the red blood cells through the inlet and out of the blood component collection reservoir. 2. The method of claim 1, wherein the centrifuge continues to rotate at first speed while pushing the plasma back through the blood component collection reservoir. 3. The method according to claim 1 or 2, in which the centrifuge is rotated at a second speed while sucking whole blood into the centrifuge from the donor. 4. The method according to claim 3, wherein the second speed is lower than the first speed. 5. Method according to any one of paragraphs. 1-4, in which plasma is separated from whole blood in a blood component collection kit that is inserted into a centrifuge. 6. The method of claim 5, wherein the centrifuge comprises a blood component separation device that rotates the blood component collection kit, wherein the blood component collection reservoir communicates with the blood component collection kit. 7. The method of claim 6, wherein the blood component collection reservoir is inserted into a collection insert channel formed in the blood component separating apparatus to hold the blood component collection reservoir. 8. The method of claim 1, comprising collecting, at least temporarily, at least a portion of the red blood cell-containing component in a chamber. 9. The method of claim 8, wherein the chamber is a drip chamber. 10. The method of claim 8, wherein whole blood taken from a donor bypasses the chamber. 11. The method of claim 1, further comprising detecting when the red blood cell-containing component exits the blood component collection reservoir through the inlet. 12. The method of claim 11, wherein said detection is associated with pressure detection. 13. The method of claim 11, further comprising allowing the red blood cell-containing component to pass from the inlet and through the drip chamber and allowing whole blood to bypass the drip chamber. 14. An apheresis system containing: a first tube having a lumen in fluid communication with a needle configured to move whole blood from the donor through the lumen; a suction pump coupled to the first tube configured to suck whole blood into the centrifuge; a centrifuge rotatable to provide centrifugal force to act on the whole blood to separate the whole blood into at least plasma and a blood component containing red blood cells; a blood component collection reservoir inserted into the centrifuge and in fluid communication with the first tube, configured to separate plasma from whole blood; a second tube in fluid communication with the blood collection reservoir, configured to move plasma from the blood component collection reservoir; a collection container in fluid communication with the second tube, configured to collect plasma; a first sensor disposed on or in the second tube for detecting the presence of red blood cells in the second tube; And, upon detection of red blood cells by the sensor and while the centrifuge continues to rotate, a return pump coupled to the second tube configured to push plasma back to the blood component collection reservoir through the second tube to move at least the component containing the red blood cells out of the reservoir to collect blood components into the first tube, and a second sensor for detecting when the red blood cell-containing component is expelled from the blood component collection reservoir through the first tube. 15. The apheresis system of claim 14, which further comprises an anticoagulant pump for sucking the anticoagulant from the anticoagulant bag and mixing the anticoagulant with whole blood in a manifold or joint in fluid communication with the first tube. 16. The apheresis system of claim 14 or 15, wherein the centrifuge includes a blood component separation device that rotates the blood component collection reservoir. 17. The apheresis system of claim 16, wherein the blood component collection reservoir is inserted into a collection insert channel formed in the blood component separating apparatus to hold the blood component collection reservoir. 18. The system of claim 14, further comprising a chamber in said first tube and a bypass tube parallel to said chamber, and means for directing whole blood through said bypass tube and directing said component containing concentrated red blood cells through said chamber. 19. The system of claim 18, wherein the chamber is a drip chamber. 20. The system of claim 14, wherein the second sensor is a pressure sensor. 21. The system according to claim 14, additionally containing: a device configured to accommodate a reservoir for collecting blood components in a centrifuge, where the device includes a channel for housing a reservoir for collecting blood components, where the channel contains two opposing walls; And a guide for the angular position of the blood component collection circuit, containing bearings and a locking plate for the circuit position; the guide for the angular position of the circuit is configured to hold the disposable flexible circuit of the said blood component collection circuit when loading the reservoir for collecting blood components into the channel. 22. The system according to claim 20, in which the flexible circuit is configured to contact the locking plate when it is held in the angular position guide of the blood component collection circuit. 23. The system according to claim 21 or 22, where the assembly is configured to be connected to a rotor configured to rotate the angular position guide of the circuit around the axis of rotation. 24. The system according to any one of paragraphs. 21–23, in which the bearings comprise pairs of roller bearings. 25. Centrifuge assembly, which contains: a centrifuge body having an outer surface and an internal cavity, where the centrifuge body is rotatable around the axis of rotation of the centrifuge assembly; a fluid separation element configured to be located at least partially in the internal cavity of the centrifuge body and rotatable relative to the centrifuge body around an axis of rotation; And a fluid line loop bracket attached to a portion of the centrifuge body and extending along the length of an outer surface of the centrifuge body, the fluid line loop bracket includes a set of bearings positioned at a point along the length of the outer surface where the set of bearings is configured to contact a tubular portion of the associated line loop fluid and maintaining the fluid line contour in an engaged position relative to the centrifuge body, allowing the fluid line contour to rotate in the engaged position. 26. The centrifuge assembly of claim 25, wherein the bearing set comprises a pair of roller bearings. 27. The centrifuge assembly according to claim 25 or 26, in which the set of bearings contains pairs of roller bearings. 28. Centrifuge assembly according to any one of paragraphs. 25-27, in which the centrifuge assembly is part of the apheresis system. 29. The centrifuge assembly of claim 28, wherein the fluid line loop is configured to be attached to a static non-rotating portion of the apheresis system at a first end of the fluid line loop through a first rigid connector, and wherein the fluid line loop is coupled to the fluid separating element environment in the internal cavity at the second end of the fluid line loop through the second rigid connector. 30. The centrifuge assembly of claim 29, wherein the second end of the fluid line loop is rotated with the fluid separation member. 31. The centrifuge assembly of claim 29 or 30, wherein the fluid line loop is configured to be physically attached to and in fluid communication with the disposable fluid separation reservoir at the second rigid connection connector. 32. The centrifuge assembly of claim 31, wherein the fluid path contour includes gaps and wherein the fluid separation reservoir includes a first flexible sheet attached to a second flexible sheet forming a fluid path, wherein the first portion of the fluid path is narrower compared to the second part of the fluid path. 33. A method for automatically loading a fluid line circuit into a centrifuge assembly, the method includes: attaching a fluid line loop at a first end to a fluid separation member of the centrifuge assembly; And rotating the fluid separation element in a first rotational direction relative to the housing of the centrifuge assembly, where rotation of the fluid separation element causes rotation of the fluid line contour relative to the housing and the guide into the channel of the circuit bracket attached to the portion of the housing, where the channel contains bearings housed in the bearing set, attached to the circuit bracket, where the bearings are configured to hold the fluid line circuit in a predetermined position relative to the housing as the centrifuge assembly rotates. 34. The method of claim 33, wherein the bearings are configured to contact a portion of the fluid line contour as the fluid line contour rotates within the channel at a predetermined position relative to the housing. 35. The method of claim 33 or 34, wherein the centrifuge body is rotatable in a first rotational direction at a first angular velocity about the axis of rotation and causes the fluid separation element to rotate at a different second angular velocity about the axis of rotation through a torsional force provided by the circuit. fluid lines. 36. The method according to claim 35, wherein the second angular velocity is twice the first angular velocity. 37. Method according to any one of paragraphs. 33-36, wherein the fluid line loop is physically attached to and fluidly coupled to a disposable fluid separation reservoir housed at least partially within the fluid separation element. 38. Method according to any one of paragraphs. 33–37, which additionally includes: attaching the second end of the fluid line loop to a rotationally fixed point of the apheresis system; And rotation, through the rotor assembly and the apheresis system motor, of the centrifuge assembly around the axis of rotation relative to a rotationally fixed point of the apheresis system. 39. A device for separating blood components, configured to accommodate an expandable separation tank in a centrifuge, wherein the separation tank is configured to separate the component from a multicomponent fluid, the device contains: a channel having a helical path for accommodating a separation reservoir corresponding to said helical path during separation of a component from a multicomponent fluid, the channel comprising: first wall; And the second wall is opposite the first wall; And wherein the first end of the channel is adjacent to the central portion of the device and the channel extends helically toward the outer perimeter of the device. 40. The device according to claim 39, wherein the upper part of the channel is narrower than the middle part of the channel. 41. The device according to claim 39 or 40, wherein at least part of the second wall has a concave surface. 42. The device of claim 39 or 40, wherein the second end of the channel is positioned such that it experiences a higher gravitational force during separation than the first end. 43. The device according to any one of paragraphs. 39-42, in which the upper part of the channel is configured to provide reinforcement to the separation tank during separation. 44. A device for separating blood components, designed for use in a centrifuge, the device contains: a housing having an axis of rotation located at the center of mass of the housing; And a fluid collection insert channel disposed in the housing and extending along a helical path extending from a first point adjacent the axis of rotation helically outward to a second point adjacent the periphery of the housing, where the fluid collection insert channel projects outward toward the periphery of the housing near the end spiral path, forming the third point of the fluid collection insert channel, located farthest from the axis of rotation. 45. The device according to claim 44, which further comprises a fluid collection chamber located in the housing and located along a portion of the spiral path, where the fluid collection insert channel is connected to the fluid collection chamber defining an access area between the interior of the fluid collection chamber and the exterior of the housing. 46. The apparatus of claim 45, wherein the fluid collection chamber is configured to receive a disposable fluid collection reservoir. 47. The device according to any one of paragraphs. 44–46, in which the distance from the axis of rotation to the third point of the spiral path is greater than the distance from the axis of rotation to the second point of the spiral path. 48. The device according to any one of paragraphs. 44-47, wherein the width of the fluid collection chamber at a point along the spiral path is greater than the width of the fluid collection insert channel at a point along the spiral path. 49. The apparatus of claim 45 or 46, wherein the fluid collection chamber further comprises a first wall adjacent to the innermost portion of the helical path and a second wall parallel to the first wall and adjacent to the outermost portion of the helical path. 50. The apparatus of claim 49, wherein the fluid collection chamber further comprises one or more beveled walls positioned between the first wall and the second wall, and wherein the one or more beveled walls are configured to direct the disposable fluid collection reservoir to a position landing in the fluid collection chamber. 51. The apparatus of claim 50, wherein the fluid inlet for the disposable fluid collection reservoir, when installed in the fluid collection chamber, is located adjacent to the axis of rotation and the first fluid path in the disposable fluid collection reservoir is located along the path a spiral path outward to the end of the disposable fluid collection reservoir located adjacent to the third point of the fluid collection insert channel, located furthest from the axis of rotation, and is fluidly connected to a second fluid path separated from the first fluid path, in a disposable fluid collection reservoir that extends in a direction from the third point, following a spiral path inward toward a fluid outlet for the disposable fluid collection reservoir located adjacent the axis of rotation. 52. The apparatus of claim 51, wherein the fluid inlet and fluid outlet are part of a connector attached to the disposable fluid collection reservoir, and wherein the body of the blood component separating device includes a connecting point engaged with the connector. 53. The device of claim 52, wherein the connector comprises at least one protruding element, wherein the connecting point comprises at least one mating protruding element, and wherein the protruding elements rigidly position the connector relative to the connecting point. 54. Centrifuge assembly, which contains: a centrifuge body having an internal cavity, where the centrifuge body is rotatable around the axis of rotation of the centrifuge assembly; And a fluid separation element located at least partially in the internal cavity of the centrifuge body and configured to rotate relative to the centrifuge body around an axis of rotation, where the fluid separation element contains an insert channel for collecting fluid, located in the fluid separation element, following a spiral a path extending from a first point adjacent the axis of rotation spirally outward to a second point located adjacent to the periphery of the fluid separation element, where the fluid collection insert channel projects outward toward the periphery of the element near the end of the spiral path, forming a third point of the fluid collection insert channel environment located farthest from the axis of rotation. 55. The centrifuge assembly of claim 54, wherein the fluid separation element further comprises a fluid collection chamber disposed in the element and following a portion of a spiral path where the fluid collection insert channel connects to the fluid collection chamber, forming an access area between an interior portion of the fluid collection chamber and an exterior portion of the fluid separation element. 56. The centrifuge assembly of claim 55, which further comprises a disposable fluid collection reservoir located in a fluid collection chamber that follows a spiral path, where the disposable fluid collection reservoir includes a fluid inlet located adjacent to the axis of rotation, and the first fluid path in the disposable fluid collection reservoir follows a spiral path outward to an end of the disposable fluid collection reservoir located adjacent to the third point of the fluid collection insert channel furthest from the axis of rotation and is fluidly connected with a second fluid path separated from the first fluid path in the disposable fluid collection reservoir extending in a direction from the third point, following a spiral path, inward to a fluid outlet for the disposable fluid collection reservoir, which is located adjacent to the axis rotation. 57. Centrifuge assembly according to any one of paragraphs. 54–56, where the centrifuge assembly is part of the apheresis system. 58. Centrifuge assembly according to any one of paragraphs. 54-57, wherein the centrifuge body is divided into an upper body and a lower body, wherein the upper body includes an internal cavity, where the upper body is rotatable between an open state and a closed state about a rotation axis that is offset and perpendicular to the rotation axis, and where the fluid collection insertion channel of the fluid separation element is accessible in the open state and inaccessible in the closed state. 59. A blood component collection circuit containing: flexible circuit; a system static loop connector disposed at a first end of the flexible loop, where the system static loop connector is connected to a fixed loop connector of the centrifuge to fix the first end of the flexible loop for rotation with the centrifuge; a blood component separating device circuit connector disposed at a second end opposite the first end of the flexible circuit, wherein the component separating device circuit connector is connected to a blood component separating device circuit connecting area, and where torque forces based on torsion in the flexible circuit are imparted to the blood component separating device through blood component separation device circuit connector; And where the flexible contour is made with the possibility of rotational movement for capture using a guide for the angular position of the contour located on the centrifuge. 60. The blood component collection circuit of claim 59, wherein the blood component collection circuit is part of a blood component collection kit and wherein the blood component collection kit is in communication with the apheresis system. 61. The blood component collection circuit according to claim 59 or 60, where the circuit angular position guide is configured to be attached to a rotor configured to rotate the circuit angular position guide and the flexible circuit around the axis of rotation. 62. Blood component collection circuit according to any one of claims. 59-61, wherein the blood component collection circuit is at least partially positioned by a circuit position locking plate. 63. Blood component collection circuit according to any one of claims. 59–62, where the flexible circuit is curved around the centrifuge. 64. Blood component collection circuit according to any one of claims. 59–63, where the flexible circuit is additionally held in a given position by means of a circuit holding bracket. 65. Blood component collection circuit according to any one of claims. 59-64, where at least part of the angular position guide of the contour contains a supporting torsion bearing of the contour. 66. The blood component collection circuit according to claim 65, where the torsion support bearing of the circuit contains a pair of roller bearings. 67. The blood component collection circuit according to claim 66, where the supporting torsion bearing of the circuit is configured to provide torsion of the flexible circuit. 68. The blood component collection circuit of claim 67, wherein the torsion causes the blood component separation device to rotate at a higher angular velocity than the centrifuge. 69. Blood component collection circuit according to any one of claims. 59-68, wherein the flexible circuit comprises two or more lumens for transporting whole blood and/or blood components within the flexible circuit. 70. A blood component collection cassette for use with a centrifuge, which contains: first port; second port; a direct-flow lumen fluidly connected to the first port and the second port; a drip chamber placed in the co-flow lumen such that fluid passing through the co-flow lumen passes through the drip chamber; And a bypass fluid flow path fluidly coupled to a co-flow lumen adjacent the first port and between the first port and the drip chamber and fluidly coupled to a co-flow lumen adjacent the second port and between the second port and the drip chamber such that the fluid flowing via a fluid flow bypass that bypasses the drip chamber, a first fluid control valve, wherein the direct flow lumen comprises a first elastic region positioned between the first connection to the first bypass leg and the drip chamber to cause the first fluid control valve to close the direct flow lumen. 71. The cassette of claim 70, wherein the bypass fluid flow path consists of a first bypass branch fluidly connected to a co-flow lumen adjacent to the first port, and a second bypass branch fluidly connected to a co-flow lumen adjacent to the second port. 72. The cassette of claim 71, wherein the fluid flow bypass path further comprises a fluid pressure ring disposed between and fluidly connected to the first bypass branch and the second bypass branch. 73. The cassette of claim 72, wherein the co-flow lumen comprises a second elastic region positioned between the second connection to the second bypass leg and the drip chamber to cause the co-flow lumen to be closed by the second fluid control valve. 74. The cassette of claim 73, wherein the flow lumen comprises a third elastic region disposed in the first bypass leg to cause the first bypass leg to be closed by the fluid control outlet valve. 75. The cassette of claim 74, wherein the first port is in fluid connection to a cassette inlet conduit that moves fluid from the donor to the cassette or fluid from the cassette to the donor, and wherein the second port is in fluid connection to the circuit inlet conduit. , which moves fluid from the cassette to the centrifuge or fluid from the centrifuge to the cassette. 76. Cassette according to any one of paragraphs. 69-75, wherein when fluid is sucked from the donor, the fluid passes through a fluid flow bypass path. 77. Cassette according to any one of paragraphs. 69-76, where when sending the fluid to the donor, the fluid passes through the co-current lumen. 78. The cassette according to claim 77, wherein when the fluid is sucked from the donor during subsequent suction, a portion of the fluid that is previously sent to the donor through the direct flow lumen is stored in the drip chamber as the fluid passes through the bypass path of the fluid flow. 79. Cassette according to any one of paragraphs. 69-78, where the cassette is part of a blood component collection kit. 80. The cassette of claim 79, wherein the blood component collection kit is part of an apheresis system. 81. Blood component collection kit, blood component collection kit contains: a centrifuge configured to separate blood components from whole blood; a cassette inlet tube configured to be fluidly connected to the donor; a circuit inlet tube configured for fluid connection with the centrifuge; a blood component collection cassette for use with a centrifuge, comprising: a first cassette port in fluid communication with the cassette inlet tube; a second cassette port in fluid communication with the circuit inlet tube; a direct-flow lumen fluidly connected to the first port of the cassette and the second port of the cassette; a drip chamber placed in the co-flow lumen such that fluid passing through the co-flow lumen passes through the drip chamber; And a bypass fluid flow path fluidly coupled to a co-flow lumen adjacent the first cassette port and between the first cassette port and the drip chamber and fluidly coupled to a co-flow lumen adjacent the second cassette port and between the second cassette port and the drip chamber such that fluid flowing through the fluid flow bypass path bypasses the drip chamber. 82. The blood component collection kit of claim 81, wherein the bypass fluid flow path comprises: a first bypass branch fluidly connected to a direct-flow lumen adjacent to the first port of the cassette; a second bypass branch fluidly connected to a direct-flow lumen adjacent to the second port of the cassette; And a fluid pressure ring disposed between and fluidly connected to the first bypass branch and the second bypass branch. 83. The blood component collection kit of claim 82, wherein the co-flow lumen comprises a first compatible region positioned between the first connection to the first bypass leg and the drip chamber that allows the first fluid control valve to close the co-flow lumen, wherein the co-flow lumen includes a second a compatible region located between the second connection with the second bypass leg and the drip chamber that allows the second fluid control valve to close the flow lumen, and in which the once-through lumen includes a third compatible area located in the first bypass leg that allows the outlet fluid control valve to close first bypass branch. 84. A kit for collecting blood components according to claim 83, in which, when absorbing fluid from a donor: the first fluid control valve and the second fluid flow control valve close and block the direct-flow lumen; And the fluid control outlet valve is opened and allows whole blood to pass through the bypass fluid flow path. 85. A kit for collecting blood components according to claim 83 or 84, in which, when sending the fluid to the donor: the first fluid control valve and the second fluid flow control valve are opened and allow the fluid to pass through the co-flow lumen; And the fluid control outlet valve is closed and the bypass fluid flow path is closed. 86. The blood component collection kit of claim 85, wherein, upon absorption of fluid from the donor during subsequent suction, a portion of the fluid previously sent to the donor through the direct flow lumen is stored in the drip chamber as the fluid passes through the bypass fluid flow path environment. 87. A method of moving fluids through a blood component collection cassette for use with a centrifuge, comprising: provision of a blood component collection cassette for use with a centrifuge, the cassette contains: a first cassette port in fluid communication with the cassette inlet tube; a second cassette port in fluid communication with the circuit inlet tube; a direct-flow lumen fluidly connected to the first port of the cassette and the second port of the cassette; a drip chamber placed in the co-flow lumen such that fluid passing through the co-flow lumen passes through the drip chamber; And a bypass fluid flow path fluidly coupled to a co-flow lumen adjacent the first cassette port and between the first cassette port and the drip chamber and fluidly coupled to a co-flow lumen adjacent the second cassette port and between the second cassette port and the drip chamber such that fluid flowing through the fluid flow bypass path bypasses the drip chamber; when absorbing whole blood from a donor: receiving whole blood from the cassette inlet tube at a first cassette port in fluid communication with the cassette inlet tube; moving the whole blood through the fluid flow bypass path to a second port of the cassette; preventing the movement of whole blood through the direct lumen; when returning red blood cells to a donor: receiving red blood cells from the circuit inlet tube at a second port of the cassette in fluid communication with the circuit inlet tube; moving red blood cells through the direct-flow lumen and drip chamber to the first port of the cassette; And preventing red blood cells from moving through the fluid flow bypass. 88. The method according to claim 87, in which, when the fluid is absorbed from the donor during subsequent suction, a portion of the fluid previously sent to the donor through the direct-flow lumen, when the red blood cells are returned to the donor, is stored in the drip chamber when the whole blood again passes through bypass path of fluid flow.

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