Method for automatically loading a fluid line loop and method for flowing fluid through a flexible cartridge

Abstract

The present invention relates to a method for automatically loading a fluid pipeline loop and a method for flowing a fluid through a soft box. The method for automatically loading a fluid pipeline loop is used to automatically load a fluid pipeline loop into a centrifuge assembly, and includes: attaching the fluid pipeline loop to a fluid separator of the centrifuge assembly at a first end; and rotating the fluid separator relative to a housing of the centrifuge assembly in a first rotational direction, wherein rotating the fluid separator causes the fluid pipeline loop to rotate relative to the housing and be guided into a channel of a loop arm attached to a part of the housing, wherein the channel includes a bearing provided in a bearing set attached to the loop arm, and wherein when the centrifuge assembly rotates, the bearing holds the fluid pipeline loop in a position relative to the housing.

Description

[0001] This application is a divisional application of the patent application with the application number 201880034604.4, the application date of April 20, 2018, and the invention title of "Methods and Systems for High-Throughput Blood Component Collection". Technical Field

[0002] The present disclosure generally relates to separating components from a multi-component fluid, and more particularly to apheresis methods and systems. Background Art

[0003] There are two common methods of blood donation / blood collection. The first method is the donation of whole blood by a donor, followed by a centrifugation process to separate the blood components from the whole blood based on the density of the blood components. During (or possibly after) the whole blood is subjected to the force generated by a centrifuge, the desired components can be manually, semi-automatically, or automatically transferred to a collection container. Another method can be apheresis collection that requires a dedicated machine.

[0004] When a donor is connected to a dedicated machine, whole blood is withdrawn from the donor using the apheresis method. The whole blood can be centrifuged again to collect only the desired blood components (such as plasma), and all other unwanted blood components can be returned to the donor during the same donation process. During the separation and collection of blood components, the donor is connected to the apheresis machine. Unfortunately, the apheresis process can be long and uncomfortable. Typically, a donor must remain connected to the machine for an hour to complete the donation of blood components. Therefore, improving the efficiency of the blood donation procedure is an ongoing desire of apheresis collection stations. Summary of the Invention

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

[0006] The embodiments can also provide methods and devices for placing parts of disposable items (such as rings) in a medical device. The embodiments can involve using a surface to automatically guide the ring. In some embodiments, the medical device can be a blood separation machine, such as an apheresis machine.

[0007] The foregoing and other needs are addressed by various aspects, embodiments, and / or configurations of the present disclosure. Additionally, although the present disclosure is presented in accordance with exemplary embodiments, it should be understood that various aspects of the present disclosure may be claimed separately.

[0008] An embodiment includes a component for separating components from a multi-component fluid, the component including: a filler including a channel for holding a disposable separation capsule, wherein the channel includes two opposing walls; and an annular rotation position guide including a plurality of bearings, which holds a disposable flexible ring when the separation capsule is loaded into the channel.

[0009] Aspects of the above component include that the annular rotation position guide includes a stop plate. Aspects of the above component include that the flexible ring contacts the stop plate when held in the annular rotation position guide. Aspects of the above component include that the component is part of a apheresis machine. Aspects of the above component include that the component is connected to a rotor that rotates the annular rotation position guide about a rotation axis. Aspects of the above component include that the plurality of bearings includes multiple pairs of roller bearings.

[0010] An embodiment includes a centrifuge assembly including: a centrifuge housing having an outer surface and an inner cavity, wherein the centrifuge housing rotates about a rotation axis of the centrifuge assembly; a fluid separator at least partially disposed in the inner cavity of the centrifuge housing and configured to rotate about the rotation axis relative to the centrifuge housing; and a fluid line loop arm attached to a portion of the centrifuge housing and extending along a length of the outer surface of the centrifuge housing, the fluid line loop arm including a bearing set disposed at a point along the length of the outer surface, wherein the bearing set is configured to contact a tube portion of an interconnected fluid line loop and hold the fluid line loop in an engagement position relative to the centrifuge housing while allowing the fluid line loop to rotate in the engagement position.

[0011] Aspects of the above centrifuge assembly include that the bearing set includes a pair of roller bearings. Aspects of the above centrifuge assembly include that the bearing set includes multiple pairs of roller bearings. Aspects of the above centrifuge assembly include that the centrifuge assembly is part of a apheresis machine. Aspects of the above centrifuge assembly include that the fluid line loop is fixed to a static non-rotating portion of the apheresis machine at a first end of the fluid line loop by a first rigid positioning connector, and wherein the fluid line loop is interconnected with the fluid separator in the lumen at a second end of the fluid line loop by a second rigid positioning connector. Aspects of the above centrifuge assembly include that the second end of the fluid line loop rotates with the fluid separator. Aspects of the above centrifuge assembly include that the fluid line loop is physically and fluidly attached to a disposable fluid separation capsule at the second rigid positioning connector. Aspects of the above centrifuge assembly include that the fluid line loop includes a plurality of lumens, and wherein the fluid separation capsule includes a first flexible plate attached to a second flexible plate forming a fluid path, wherein a first portion of the fluid path is narrower than a second portion of the fluid path.

[0012] An embodiment includes a method for automatically loading a fluid line loop into a centrifuge assembly, the method comprising: attaching the fluid line loop to a fluid separator of the centrifuge assembly at a first end; and rotating the fluid separator relative to a housing of the centrifuge assembly in a first rotational direction, wherein rotating the fluid separator causes the fluid line loop to rotate relative to the housing and to be guided into a channel of a loop arm attached to a portion of the housing, wherein the channel includes a bearing disposed in a bearing set attached to the loop arm, and wherein the bearing holds the fluid line loop in position relative to the housing when the centrifuge assembly rotates.

[0013] Aspects of the above method include that the bearing contacts a portion of the fluid line loop when the fluid line loop rotates in position relative to the housing within the channel. Aspects of the above method include that the centrifuge housing rotates about a rotational axis at a first angular velocity in the first rotational direction and that the fluid separator rotates about the rotational axis at a different second angular velocity by a torsional force provided by the fluid line loop. Aspects of the above method include that the second angular velocity is substantially twice the first angular velocity. Aspects of the above method include that the fluid line loop is physically and fluidly attached to a disposable fluid separation bladder that is at least partially disposed within the fluid separator. Further aspects of the above method include: connecting a second end of the fluid line loop to a rotational fixed point of a apheresis machine; and rotating the centrifuge assembly relative to the rotational fixed point of the apheresis machine about the rotational axis by a rotor and motor assembly of the apheresis machine.

[0014] An embodiment includes a method for collecting blood components by apheresis, the method comprising: withdrawing whole blood from a donor into a centrifuge; rotating the centrifuge so that a centrifugal force acts on 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; extracting the first blood component into a container; detecting when a second blood component is extracted; after detecting the second blood component and while the centrifuge continues to rotate, forcing the separated first blood component back into the centrifuge so that at least the third blood component flows out of the centrifuge and back to the donor.

[0015] Aspects of the method include, wherein the first blood component is one or more of plasma, platelets, red blood cells, and / or high hematocrit blood. Aspects of the 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 high hematocrit blood. Aspects of the method include, wherein the first blood component is two or more of plasma, platelets, red blood cells, and / or high hematocrit blood. Aspects of the method include, wherein when separating the first blood component from whole blood, the centrifuge rotates at a first speed. Aspects of the method include, wherein when forcing the separated first blood component back into the centrifuge, the centrifuge continues to rotate at the first speed. Aspects of the method include, wherein when aspirating whole blood from a blood donor into the centrifuge, the centrifuge rotates at a second speed. Aspects of the method include, wherein the second speed is slower than the first speed. Aspects of the method include, wherein the first blood component is separated from whole blood in a blood component collection device inserted into the centrifuge. Aspects of the method include, wherein the centrifuge includes a filler that rotates a blood component collection bladder associated with the blood component collection device. Aspects of the method include, wherein the blood component collection bladder is inserted into a collection insertion channel formed in the filler to hold the blood component collection bladder.

[0016] Embodiments include a apheresis system that includes: a first tube having a lumen in fluid communication with a needle, the first tube allowing whole blood from a blood donor to flow through the lumen; a suction pump engaged with the first tube, the suction pump aspirating whole blood from the blood donor into the centrifuge; a centrifuge that rotates to apply centrifugal force to whole blood to separate the whole blood into at least a first blood component and a third blood component; a blood component collection bladder inserted into the centrifuge and in fluid communication with the first tube, the blood component collection bladder separating the first blood component from whole blood; a second tube in fluid communication with the blood collection bladder, the second tube allowing the first blood component to flow from the blood component collection bladder; a collection container in fluid communication with the second tube, the collection container extracting the first blood component from the apheresis system; a sensor positioned at a physical location proximate to the second tube to detect when a second blood component is extracted from whole blood; and after the sensor detects the second blood component and while the centrifuge continues to rotate, a return pump engaged with the second tube forces the separated first blood component to flow through the second tube back into the blood component collection bladder, such that at least the third blood component flows from the blood component collection bladder and back into the blood donor.

[0017] Aspects of the apheresis system include where the first blood component is plasma and the second blood component is platelets, red blood cells, and / or high hematocrit blood. Further aspects of the apheresis system include an anticoagulant pump to withdraw anticoagulant from an anticoagulant bag and mix the anticoagulant and whole blood at a manifold or junction in fluid communication with a first tube. Aspects of the apheresis system include where the centrifuge includes a filler that rotates a blood component collection bladder. Aspects of the apheresis system include where the blood component collection bladder is inserted into a collection insertion channel formed in the filler to hold the blood component collection bladder.

[0018] Embodiments include a blood component collection device associated with an apheresis system, the blood component collection device including: a needle inserted into a donor's blood vessel to withdraw whole blood from the donor; a first tube having a lumen in fluid communication with the needle, the first tube allowing whole blood to flow through the lumen, where a suction pump engaged with the first tube withdraws whole blood from the donor; a blood component collection bladder inserted into a centrifuge and in fluid communication with the first tube, the blood component collection bladder separating a first blood component and a third component from the whole blood; a second tube in fluid association with the blood collection bladder, the second tube allowing the first blood component to flow from the blood component collection bladder; and, a collection container in fluid association with the second tube, the collection container extracting the first blood component from the apheresis system, where a sensor is positioned at a physical location adjacent to the second tube to detect when a second blood component is extracted from the whole blood; and where, after the sensor detects the second blood component and while the centrifuge continues to rotate, a return pump engaged with the second tube forces the separated first blood component to flow through the second tube back to the blood component collection bladder to allow at least a third blood component to flow from the blood component collection bladder and back to the donor.

[0019] Aspects of the blood component collection device include where the first blood component is plasma and the second blood component is platelets. Aspects of the blood component collection device include where the suction pump is disengaged when the return pump forces the separated first blood component through the second tube back to the blood component collection bladder to move at least a third blood component from the blood component collection bladder and back to the donor. Aspects of the blood component collection device include where the blood component collection bladder is inserted and held in a filler in the centrifuge, the filler rotating the blood component collection bladder. Aspects of the blood component collection device include where the blood component collection bladder is inserted into a collection insertion channel formed in the filler to hold the blood component collection bladder.

[0020] The embodiments include a filler for holding a separation capsule in which components are separated from a complex fluid. The filler includes: a channel for holding the separation capsule during separation of components from the complex fluid, the channel including: a first wall; and a second wall opposite the first wall; and wherein a first end of the channel is adjacent a central portion of the filler and the channel spirals towards an outer periphery of the filler.

[0021] Aspects of the filler described above include, wherein a top portion of the channel is narrower than a middle portion of the channel. Aspects of the filler described above include, wherein at least a portion of the second wall has a concave surface. Aspects of the filler described above include, wherein a second end of the channel is positioned such that it experiences greater gravitational force than the first end during separation. Aspects of the filler described above include, wherein the top portion of the channel provides reinforcement to the separation capsule during separation.

[0022] The embodiments include a fluid separation filler including: a body having a rotational axis substantially at the centroid of the body; and a fluid collection insertion channel disposed in the body and following a generally helical path that spirally extends outward from a first point adjacent the rotational axis to a second point disposed adjacent the outer periphery of the body, wherein the fluid collection insertion channel bulges outward towards the outer periphery of the body near an end of the generally helical path to define a third point of the fluid collection insertion channel that is disposed furthest from the rotational axis.

[0023] Aspects of the fluid separation filler further include: a fluid collection chamber disposed within the body and following a portion of a generally helical path, wherein a fluid collection insertion channel is connected to the fluid collection chamber, and the fluid collection chamber defines an access area between the interior of the fluid collection chamber and the exterior of the body. Aspects of the fluid separation filler include that the fluid collection chamber is configured to receive a disposable fluid collection bladder. Aspects of the fluid separation filler include that the dimension from the axis of rotation to a third point of the generally helical path is greater than the dimension from the axis of rotation to a second point of the generally helical path. Aspects of the fluid separation filler include that the width of the fluid collection chamber at a point along the generally helical path is greater than the width of the fluid collection insertion channel at a point along the generally helical path. Aspects of the fluid separation filler include that the fluid collection chamber further includes a first wall following the innermost portion of the generally helical path and a second wall substantially parallel to the first wall and following the outermost portion of the generally helical path. Aspects of the fluid separation filler include that the fluid collection chamber further includes one or more tapered walls disposed between the first wall and the second wall, and wherein the one or more tapered walls are configured to guide the disposable fluid collection bladder to a seated position within the fluid collection chamber. Aspects of the fluid separation filler include that when the disposable fluid collection bladder is installed in the fluid collection chamber, a fluid inlet for the disposable fluid collection bladder is disposed near the axis of rotation, and a first fluid path in the disposable fluid collection bladder follows the generally helical path outward toward an end of the disposable fluid collection bladder, which end is disposed near a third point at the position farthest from the axis of rotation of the fluid collection insertion channel, and is fluidly interconnected with a second fluid path that is fluidly separated from the first fluid path within the disposable fluid collection bladder to extend along a direction following the generally helical path inward from the third point toward a fluid outlet of the disposable fluid collection bladder disposed adjacent to the axis of rotation. Aspects of the fluid separation filler include that the fluid inlet and the fluid outlet are portions of a connector attached to the disposable fluid collection bladder, and wherein the body of the fluid separation filler includes a connection point that engages the connector. Aspects of the fluid separation filler include that the connector includes at least one key feature, wherein the connection point includes at least one matching key feature, and wherein the key features rigidly position the connector relative to the connection point.

[0024] The embodiment includes a centrifuge assembly, comprising: a centrifuge housing having an inner cavity, wherein the centrifuge housing rotates about a rotation axis of the centrifuge assembly; and a fluid separation body at least partially disposed in the inner cavity of the centrifuge housing and configured to rotate about the rotation axis relative to the centrifuge housing, wherein the fluid separation body includes a fluid collection insertion channel disposed within the fluid separation body, the fluid collection insertion channel following a generally helical path that spirally extends outward from a first point adjacent the rotation axis to a second point adjacent the periphery of the fluid separation body, wherein the fluid collection insertion channel bulges outward toward the periphery of the body near one end of the generally helical path to define a third point of the fluid collection insertion channel that is disposed farthest from the rotation axis.

[0025] Aspects of the centrifuge assembly described above include, wherein the fluid separation body further includes a fluid collection chamber disposed within the body and following a portion of the generally helical path, wherein the fluid collection insertion channel is connected to the fluid collection chamber, and the fluid collection chamber defines an access region between the interior of the fluid collection chamber and the exterior of the fluid separation body. Aspects of the centrifuge assembly further include a disposable fluid collection bladder disposed within the fluid collection chamber along the generally helical path, wherein the disposable fluid collection bladder includes a fluid inlet disposed adjacent the rotation axis and a first fluid path within the disposable fluid collection bladder that follows the generally helical path outward toward an end of the disposable fluid collection bladder that is disposed adjacent the third point of the fluid collection insertion channel that is disposed away from the rotation axis, and is fluidly interconnected with a second fluid path that is separated from the first fluid path within the disposable fluid collection bladder, the second fluid path extending along a direction that follows the generally helical path inward from the third point toward a fluid outlet for the disposable fluid collection bladder that is disposed adjacent the rotation axis. Aspects of the centrifuge assembly include, wherein the centrifuge assembly is part of a apheresis machine. Aspects of the centrifuge assembly include, wherein the centrifuge housing is divided into an upper housing and a lower housing, wherein the upper housing includes the inner cavity, wherein the upper housing is rotatable about a pivot axis between an open state and a closed state, the pivot axis being offset and generally perpendicular to the rotation axis, and wherein the fluid collection insertion channel of the fluid separation body is accessible in the open state and inaccessible in the closed state.

[0026] An embodiment includes a blood component collection loop, comprising: a flexible loop; a system static loop connector disposed at a first end of the flexible loop, wherein the system static loop connector is connected to a fixed loop connector of a centrifuge to fix the first end of the flexible loop and thus rotate with the centrifuge; a filler loop connector disposed at a second end of the flexible loop opposite the first end, wherein the filler loop connector is connected to a loop connection area of a filler, and wherein a torsional force based on the torsion in the flexible loop is applied to the filler through the filler loop connector; and wherein the flexible loop is rotationally moved to be captured by a loop rotation position guide disposed on the centrifuge.

[0027] Aspects of the blood component collection loop described above include that the blood component collection loop is part of a blood component collection device, and wherein the blood component collection device is associated with a apheresis system. Aspects of the blood component collection loop described above include that the loop rotation position guide is attached to a rotor that rotates the loop rotation position guide and the flexible loop about a rotation axis. Aspects of the blood component collection loop described above include that the blood component collection loop is at least partially positioned by a loop position stop plate. Aspects of the blood component collection loop described above include that the flexible loop bends around the centrifuge. Aspects of the blood component collection loop described above include that the flexible loop is also held in place by a loop receiving bracket at the flexible loop. Aspects of the blood component collection loop described above include that at least a portion of the loop rotation position guide includes a loop torsion support bearing. Aspects of the blood component collection loop described above include that the loop torsion support bearing includes a pair of roller bearings. Aspects of the blood component collection loop described above include that the loop torsion support bearing enables the flexible loop to twist. Aspects of the blood component collection loop described above include that the torsion causes the filler to rotate at a greater angular velocity than the centrifuge. Aspects of the blood component collection loop described above include that the flexible loop may include two or more lumens to allow whole blood and / or blood components to flow within the flexible loop.

[0028] An embodiment includes an assembly for loading a flexible loop, the assembly comprising: a loop rotation position guide that includes a channel for holding a flexible loop of a blood component collection device; a loop torsion support bearing that is disposed in the channel and on a portion of the loop rotation position guide to support the flexible loop; and a loop capture arm, wherein the loop capture arm is positioned adjacent to the channel and connected to the loop rotation position guide to guide the flexible loop into the channel and contact the loop torsion support bearing.

[0029] Aspects of the above component include, where the component is part of a apheresis machine, and where the ring rotation position guide is attached to a centrifuge that rotates the ring rotation position guide and the flexible ring about a rotation axis. Aspects of the above component include, where the ring rotation position guide further includes a ring position stop plate to further position the flexible ring. Further aspects of the above component include a ring receiving bracket that is positioned within the plane having the ring rotation position guide and is disposed on the centrifuge to further capture the flexible ring.

[0030] Embodiments include a method for automatically loading a flexible ring into a component, the method including: connecting a system static ring connector disposed at a first end of the flexible ring to a fixed ring connector of a centrifuge to secure the first end of the flexible ring and thereby rotate with the centrifuge; connecting a filler ring connector disposed at a second end of the flexible ring opposite the first end to a ring connection area of a filler, and where a torsional force based on a twist in the flexible ring is applied to the filler through the filler ring connector; and rotationally moving the flexible ring into a ring rotation position guide located on the centrifuge.

[0031] Aspects of the above method include, where the flexible ring engages a ring twist support bearing disposed within a channel formed by the ring rotation position guide, where the ring twist support bearing supports the flexible ring. Aspects of the above method include, where when rotated, a ring capture arm contacts the flexible ring to guide the flexible ring into the channel and contacts the ring twist support bearing. Aspects of the above method include, where the ring rotation position guide further includes a ring position stop plate to prevent the flexible ring from over-rotating past the channel. Aspects of the above method include, where a ring receiving bracket located within the plane having the ring rotation position guide and disposed on the centrifuge further captures and holds the flexible ring.

[0032] Embodiments include a soft cassette that includes: a first cassette port; a second cassette port; a direct flow lumen fluidly connected to the first cassette port and the second cassette port; a drip chamber that is internally disposed within the direct flow lumen such that fluid flowing through the direct flow lumen passes through the drip chamber; and a fluid flow bypass path that is fluidly connected to the direct flow lumen both between the first port and the drip chamber and adjacent the first port and between the second port and the drip chamber and adjacent the second port such that fluid flowing through the fluid flow bypass path bypasses the drip chamber.

[0033] Aspects of the flexible cassette include, wherein the fluid flow bypass includes a first bypass branch fluidly connected to the direct flow lumen adjacent the first cassette port and a second bypass branch fluidly connected to the direct flow lumen adjacent the second cassette port. Aspects of the flexible cassette include, wherein the fluid flow bypass path further includes a fluid pressure loop disposed between and fluidly connected to the first bypass branch and the second bypass branch. Aspects of the flexible cassette include, wherein the direct flow lumen includes a first compliant region disposed between a first connector having the first bypass branch and the drip chamber, the first compliant region allowing a first fluid control valve to block the direct flow lumen. Aspects of the flexible cassette include, wherein the direct flow lumen includes a second compliant region disposed between a second connection having the second bypass branch and the drip chamber, the second compliant region allowing a second fluid control valve to block the direct flow lumen. Aspects of the flexible cassette include, wherein the direct flow lumen includes a third compliant region disposed in the first bypass branch, which allows a suction fluid control valve to block the first bypass branch. Aspects of the flexible cassette include, wherein the first cassette port is fluidly connected to a cassette inlet tube that allows fluid to flow from a blood donor into the flexible cassette or from the flexible cassette into the blood donor, and wherein the second cassette port is fluidly connected to a loop inlet tube that allows fluid to flow from the flexible cassette into a centrifuge or from the centrifuge into the flexible cassette. Aspects of the flexible cassette include, wherein when fluid is withdrawn from the blood donor, the fluid flows through the fluid flow bypass path. Aspects of the flexible cassette include, wherein when fluid is delivered to the blood donor, the fluid flows through the direct flow lumen. Aspects of the flexible cassette include, wherein when fluid is withdrawn from the blood donor during a subsequent draw, a portion of the fluid previously delivered to the blood donor through the direct flow lumen is retained in the drip chamber as the fluid flows through the fluid flow bypass path. Aspects of the flexible cassette include, wherein the flexible cassette is part of a blood component collection device. Aspects of the flexible cassette include, wherein the blood component collection device is part of a apheresis system.

[0034] Embodiments include a blood component collection device, the blood component collection device including: a centrifuge for separating blood components from whole blood; a cassette inlet tube fluidly connected to a blood donor; a loop inlet tube fluidly connected to the centrifuge; a flexible cassette including: a first cassette port fluidly connected to the cassette inlet tube; a second cassette port fluidly connected to the loop inlet tube; a direct flow lumen fluidly connected to the first cassette port and the second cassette port; a drip chamber internally disposed in the direct flow lumen such that fluid flowing through the direct flow lumen flows through the drip chamber; and a fluid flow bypass path fluidly connected to the direct flow lumen both between the first cassette port and the drip chamber and adjacent the first cassette port and between the second port and the drip chamber and adjacent the second cassette port such that fluid flowing through the fluid flow bypass path bypasses the drip chamber.

[0035] Aspects of the blood component collection device include, wherein the fluid flow bypass path includes: a first bypass branch fluidly connected to the direct flow lumen adjacent the first cassette port; a second bypass branch fluidly connected to the direct flow lumen adjacent the second cassette port; and a fluid pressure loop disposed between and fluidly connected to the first bypass branch and the second bypass branch. Aspects of the blood component collection device include, wherein the direct flow lumen includes a first compliant region disposed between a first connector having the first bypass branch and the drip chamber, the first compliant region allowing a first fluid control valve to block the direct flow lumen, wherein the direct flow lumen includes a second compliant region disposed between a second connector having the second bypass branch and the drip chamber, the second compliant region allowing a second fluid control valve to block the direct flow lumen, and wherein the direct flow lumen includes a third compliant region disposed in the first bypass branch, the third compliant region allowing a suction fluid control valve to block the first bypass branch. Aspects of the blood component collection device include, wherein, when fluid is being aspirated from a donor: the first fluid control valve and the second fluid flow control valve are closed and block the direct flow lumen; and the suction fluid control valve is open and allows whole blood to pass through the fluid flow bypass path. Aspects of the blood component collection device include, wherein, when fluid is being delivered to a donor: the first fluid control valve and the second fluid flow control valve are open and allow fluid to pass through the direct flow lumen; and the suction fluid control valve is closed and blocks the fluid flow bypass path. Aspects of the blood component collection device include, wherein, when fluid is being aspirated from a donor during a subsequent draw, a portion of the fluid previously delivered to the donor through the direct flow lumen is retained in the drip chamber as the fluid passes through the fluid flow bypass path.

[0036] An embodiment includes a method for passing a fluid through a flexible cassette, the method comprising: providing a flexible cassette comprising: a first cassette port fluidly connected to a cassette inlet tube; a second cassette port fluidly connected to a loop inlet tube; a direct flow lumen fluidly connecting the first cassette port and the second cassette port; a drip chamber internally disposed in the direct flow lumen such that fluid flowing through the direct flow lumen flows through the drip chamber; and a fluid flow bypass path fluidly connected to the direct flow lumen both between the first cassette port and the drip chamber and adjacent to the first cassette port, and between the second cassette port and the drip chamber and adjacent to the second cassette port, such that fluid flowing through the fluid flow bypass path bypasses the drip chamber; when withdrawing whole blood from a blood donor: receiving whole blood from the cassette inlet tube at the first cassette port fluidly connected to the cassette inlet tube; passing the whole blood through the fluid flow bypass to the second cassette port; preventing the whole blood from passing through the direct lumen; when returning red blood cells to the blood donor: receiving red blood cells from the loop inlet tube at the second cassette port fluidly connected to the loop inlet tube; passing the red blood cells through the direct flow lumen and the drip chamber to the first cassette port; and preventing the red blood cells from moving through the fluid flow bypass path.

[0037] Aspects of the above method include, wherein, when withdrawing fluid from the blood donor during a subsequent draw, a portion of the fluid that was delivered to the blood donor through the direct flow lumen when returning red blood cells to the blood donor previously is retained in the drip chamber when the whole blood passes through the fluid flow bypass path again.

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

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

[0040] One or more devices adapted to perform any one or more of the above aspects / embodiments are substantially disclosed herein.

[0041] According to certain aspects, embodiments, and / or configurations, the present disclosure can provide many advantages. By maintaining the rotational speed of the centrifuge while returning unwanted blood components to the blood donor, the apheresis procedure can be reduced by possibly 30% or more in terms of time. The increased efficiency enables faster and more comfortable blood donation. With a faster blood donation time, the blood donation center can obtain more blood donations in a day, thereby increasing productivity and revenue. In addition, if the blood donation speed is faster, the blood donor is more likely to come back to donate again. Having a faster blood donation speed can also enable the blood donation center to attract blood donors from other blood donation centers with slower blood donation speeds.

[0042] In the present disclosure, these and other advantages will be apparent.

[0043] The phrases “at least one”, “one or more”, and “and / or” are open expressions and can be conjunctive or disjunctive in operation. 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” refers 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] The term “a” or “an” entity means one or more of that entity. Thus, the terms “a” or “an”, “one or more”, and “at least one” may be used interchangeably herein. It should also be noted that the terms “comprising”, “including”, and “having” may be used interchangeably.

[0045] As used herein, the term “donor” can refer to anyone who provides a fluid such as whole blood to a apheresis system. A donor can also be a patient who has also temporarily provided a fluid to the apheresis system and the fluid is processed, disposed of, manipulated, etc. before being returned to the patient.

[0046] As used herein, the term “automated” and variations thereof refer to any process or operation that is completed without substantial human input when the process or operation is performed. However, a process or operation can be automated if input is received prior to the performance of the process or operation, even if the performance of the process or operation uses substantial or insubstantial human input. Human input is considered substantial if it affects the manner in which the process or operation is performed. Human input that consents to the performance of the process or operation is not considered “substantial”.

[0047] As used herein, the term "computer-readable medium" refers to any tangible storage and / or transmission medium that participates in providing instructions to a processor for execution. Such a medium may take many forms, including but not limited to non-volatile media, volatile media, and transmission media. Non-volatile media includes, for example, NVRAM, magnetic disks, or optical disks. Volatile media includes dynamic memory, such as main memory. Common forms of computer-readable media include, for example, floppy disks, flexible disks, hard disks, magnetic tape, or any other magnetic medium, magneto-optical medium, CD-ROM, any other optical medium, punch cards, paper tape, any other physical medium with hole patterns, RAM, PROM, EPROM, FLASH-EPROM, solid state media like memory cards, any other memory chip or cartridge, a carrier wave as described hereinafter, or any other medium readable by a computer. Digital file attachments to e-mail or other independent information archives or sets of archives are considered equivalent to a distribution medium of a tangible storage medium. When a computer-readable medium is configured as a database, it should be understood that the database can be any type of database, such as relational, hierarchical, object-oriented, and / or the like. Thus, the present disclosure is considered to include a tangible storage medium or a distribution medium and equivalents and successors thereof recognized by the prior art, in which the software implementation of the present disclosure is stored.

[0048] As used herein, the term "module" refers to any known or later developed hardware, software, firmware, artificial intelligence, fuzzy logic, or a combination of hardware and software capable of performing the functions associated with that element.

[0049] As used herein, the terms "determine", "operation", and "calculate" and their variants are used interchangeably and include any type of method, process, mathematical operation, or technique.

[0050] It should be understood that, in accordance with paragraph 6 of Section 112 of Title 35 of the United States Code, the term "means" as used herein shall be given its broadest possible interpretation. Thus, claims containing the term "means" shall cover all structures, materials, or acts set forth herein, and their equivalents. In addition, structures, materials, or acts and their equivalents shall include all that is described in the Summary of the Invention, the Description of the Drawings, the Detailed Description, the Abstract, and the Claims.

[0051] The foregoing is a simplified summary of the present disclosure to provide an understanding of some aspects of the present disclosure. This summary is neither a broad overview nor an exhaustive overview of the present disclosure and its various aspects, embodiments, and / or configurations. It is neither intended to identify key or important elements of the present disclosure nor to describe the scope of the present disclosure, but rather presents selected concepts of the present disclosure in a simplified form as an introduction to the more detailed description presented below. It is understood that other aspects, embodiments, and / or configurations of the present disclosure are possible using one or more of the features described above or in the detailed description below, either alone or in combination. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] Figure 1 A perspective view showing an operating environment of a apheresis system according to an embodiment of the present disclosure;

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

[0054] Figure 2B A first detailed perspective view of a pump of an apheresis system according to an embodiment of the present disclosure;

[0055] Figure 2C A second detailed perspective view of a pump of an apheresis system according to an embodiment of the present disclosure;

[0056] Figure 2D A detailed perspective view of a fluid valve control system according to an embodiment of the present disclosure;

[0057] Figure 3A A detailed perspective view of a disposable soft cassette assembly according to an embodiment of the present disclosure;

[0058] Figure 3B A perspective view of a disposable soft cassette according to an embodiment of the present disclosure;

[0059] Figure 3C is a front elevation sectional view taken along line 3C of Figure 3B ;

[0060] Figure 3D is a front elevation sectional view taken along line 3D of Figure 3B ;

[0061] Figure 4A A perspective view showing a centrifuge assembly in an apheresis system according to an embodiment of the present disclosure;

[0062] Figure 4B shows Figure 4A a front perspective view of the centrifuge assembly shown;

[0063] Figure 4C shows Figure 4A a rear perspective view of the centrifuge assembly shown;

[0064] Figure 4D is a schematic cross-sectional view of a centrifuge assembly in a closed state according to an embodiment of the present disclosure;

[0065] Figure 4E is a schematic cross-sectional view of a centrifuge assembly in a partially open state according to an embodiment of the present disclosure;

[0066] Figure 4F is a schematic cross-sectional view of a centrifuge assembly in an open state according to an embodiment of the present disclosure;

[0067] Figure 4G shows a perspective view of a filler for a centrifuge according to an embodiment of the present disclosure;

[0068] Figure 4H is a plan view of a filler for a centrifuge according to an embodiment of the present disclosure;

[0069] Figure 4I is a schematic plan view of a generally spiral receiving channel for a filler according to an embodiment of the present disclosure;

[0070] Figure 4J is along Figure 4H a front sectional view taken along line 4J;

[0071] Figure 4K is a detailed cross-sectional view of a part of a channel in a filler according to an embodiment of the present disclosure;

[0072] Figure 4L shows different states of a fluid collection bladder disposed within a channel in a filler at Figure 4K ;

[0073] Figure 5A shows a schematic diagram of a fluid component collection device according to an embodiment of the present disclosure;

[0074] Figure 5B shows a front view of a fluid component collection ring according to an embodiment of the present disclosure;

[0075] Figure 5C shows a cross-section of a bladder of a fluid component collection ring according to an embodiment of the present disclosure;

[0076] Figure 5D shows a cross-section of a bladder of a fluid component collection ring according to another embodiment of the present disclosure;

[0077] Figure 5E shows a perspective view of a fluid component collection ring in a bent state according to an embodiment of the present disclosure;

[0078] Figure 5FShows a perspective view of a fluid component collection ring in a loaded state according to an embodiment of the present disclosure;

[0079] Figure 5G Shows a perspective view of a fluid component collection ring loaded into a filler according to an embodiment of the present disclosure;

[0080] Figure 5H Shows a perspective view of a fluid component collection ring loaded in a filler according to an embodiment of the present disclosure;

[0081] Figure 6A Shows a schematic cross-sectional view of a centrifuge assembly in a first ring loading state according to an embodiment of the present disclosure;

[0082] Figure 6B Shows a schematic cross-sectional view of a centrifuge assembly in a second ring loading state according to an embodiment of the present disclosure;

[0083] Figure 6C Shows a schematic cross-sectional view of a centrifuge assembly in a third ring loading state according to an embodiment of the present disclosure;

[0084] Figure 7A Shows a schematic plan view of a centrifuge assembly in a ring loading state according to an embodiment of the present disclosure;

[0085] Figure 7B Shows a schematic plan view of a centrifuge assembly in an operating state according to an embodiment of the present disclosure;

[0086] Figure 8 Is a functional diagram of an embodiment of a apheresis system according to an embodiment of the present disclosure;

[0087] Figure 9 Is a block diagram of an electronic system of a apheresis system according to an embodiment of the present disclosure;

[0088] Figure 10 Is another block diagram of an electronic system of a apheresis system according to an embodiment of the present disclosure;

[0089] Figure 11 Is another block diagram of an electronic system of a apheresis system according to an embodiment of the present disclosure;

[0090] Figure 12 Is a process diagram of a method for performing apheresis according to an embodiment of the present disclosure;

[0091] Figure 13 Is a process diagram of a method for performing apheresis according to an embodiment of the present disclosure;

[0092] Figure 14 Is a process diagram of a method for performing apheresis according to an embodiment of the present disclosure;

[0093] Figure 15 is a process diagram of a method for performing apheresis according to an embodiment of the present disclosure;

[0094] Figure 16 is a process diagram of a method for inserting a disposable article into a filler of an apheresis system according to an embodiment of the present disclosure;

[0095] Figure 17A is a functional diagram of an apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0096] Figure 17B is another functional diagram of an apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0097] Figure 17C is another functional diagram of an apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0098] Figure 17D is another functional diagram of an apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0099] Figure 17E is another functional diagram of an apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0100] Figure 17F is another functional diagram of an apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0101] Figure 17G is another functional diagram of an apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0102] Figure 17H is another functional diagram of an apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0103] Figure 17I is another functional diagram of an apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0104] Figure 17J is another functional diagram of an apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0105] Figure 17K is another functional diagram of an apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0106] Figure 17L is another functional diagram of an apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0107] Figure 17M is another functional diagram of an apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0108] Figure 17N is another functional diagram of the apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0109] Figure 17O is another functional diagram of the apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0110] Figure 17P is another functional diagram of the apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0111] Figure 17Q is another functional diagram of the apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0112] Figure 17R is another functional diagram of the apheresis system during the apheresis process according to an embodiment of the present disclosure;

[0113] Figure 17S is another functional diagram of the apheresis system during the apheresis process according to an embodiment of the present disclosure; and

[0114] Figure 17T is another functional diagram of the apheresis system during the apheresis process according to an embodiment of the present disclosure.

[0115] In the drawings, similar components and / or features may have the same reference numerals. Additionally, different components of the same type may be distinguished by following the reference numeral with a letter that differentiates the similar components. If only the first reference numeral is used in the specification, the description applies to any one of the similar components having the same first reference numeral, regardless of the second reference numeral. Detailed Embodiments

[0116] Embodiments of the present disclosure will be described in conjunction with apheresis methods and systems. The following embodiments may be described with respect to separating blood components from whole blood. However, this example process is provided for illustrative purposes only. Note that the embodiments are not limited to the following description. These embodiments are intended for products, processes, devices, and systems for separating any complex liquid. Thus, the present disclosure is not limited to separating blood components from whole blood.

[0117] Reference Figure 1 , a perspective view of an operating environment 100 of an apheresis system 200 according to an embodiment of the present disclosure is shown. The operating environment 100 may include the apheresis system 200, a donor 102, and one or more connectors (e.g., donor supply tube 104, cassette inlet tube 108A, anticoagulant tube 110, etc.) flowing from the donor 102 to the apheresis system 200 and / or vice versa. As Figure 1As shown, the donor blood supply tube 104 can be fluidly connected to at least one blood vessel (e.g., vein) of the donor 102 through venipuncture. For example, a cannula connected to one end of the donor blood supply tube 104 can be inserted through the skin of the donor 102 into the target site or vein. Such a connection can provide a venous path for blood to flow from the donor 102 to the apheresis system 200 and / or for blood components to return to the donor 102. In some embodiments, the fluid path and connection can form an extracorporeal tubing circuit of the apheresis system 200.

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

[0119] The anticoagulant can include one or more of citrate and / or unfractionated heparin, but is not limited thereto. The AC bag and other bags or bottles described herein can be made of one or more of, for example, polyvinyl chloride (PVC), plasticized-PVC, polyethylene, ethylene vinyl acetate (EVA), rubber, silicone, thermoplastics, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof, but are not limited thereto. The amount of AC in the AC bag 114 can vary based on various factors, including the weight of the donor 102, the volume flow rate of the blood from the donor, etc. In one example, the amount in the AC bag 114 can be 250 mL to 500 mL, but the amount in the AC bag 114 can be greater than or less than this amount.

[0120] In some embodiments, the apheresis system 200 may include a plasma collection bottle 122 or container, a saline fluid contained in a saline bag 118, and one or more pipelines or tubes 116, 120 (e.g., fluid delivery tubes, etc.) that connect the saline bag 118 and the plasma collection bottle 122 to the extracorporeal tube circuit of the apheresis system 200. The amount of saline provided in the saline bag 118 may be 500 mL to 800 mL, but the amount in the saline bag 118 may be greater or less than this amount. An example donation volume of a blood component (e.g., plasma) may be 880 mL. Thus, the plasma collection bottle 122 may accommodate at least this amount of plasma. In some embodiments, the plasma collection bottle 122 may include a connection point disposed at, near, or in physical proximity to the substantially bottommost portion of the plasma collection bottle 122 (e.g., when the plasma collection bottle 122 is installed in the plasma collection bracket 232C, as Figure 2A shown). The connection point may include one or more connectors configured to interconnect with the plasma tube 120 to receive and / or convey plasma. The arrangement of the connection point at the bottom of the plasma collection bottle 122 may allow the plasma contained in the plasma collection bottle 122 to pass through the pipeline and move out of the plasma tube 120 without trapping air bubbles, etc., as described herein. In some embodiments, the plasma collection bottle 122 may be configured as a flexible bag, a rigid container, and / or other container, and thus, the plasma collection bottle 122 is not limited to a bottle or bottle-shaped container.

[0121] Figure 2A is shown Figure 1 a perspective view of the apheresis system 200 described in. The apheresis system 200 may provide a continuous whole blood separation process. In one embodiment, whole blood may be drawn from a donor 102 and substantially continuously provided to a blood component separation device of the apheresis system 200, in which the blood may be separated into different components, and at least one of these blood components may be collected from the apheresis system 200. In some embodiments, one or more separated blood components may be collected for subsequent use or returned to the donor 102. Blood may be drawn from the donor 102 and introduced into the centrifuge of the apheresis system 200 through an opening 220 in the access panel 224 of the apheresis system 200. In one embodiment, the tubes 104, 108A, 108B, 112, 116, 120 for the extracorporeal tube circuit may together define a closed, sterile, and disposable system or blood component collection device, which will be further described below.

[0122] Examples of apheresis systems, plasma apheresis systems, and other apheresis systems that may be used with embodiments of the present disclosure, such as the apheresis system 200, include but are not limited to (SPECTRA ) apheresis systems, Spectrophotometric Apheresis System and TRIMA Automated blood collection systems, all of which are manufactured by Terumo BCT of Lakewood, Colorado.

[0123] The operation of various pumps, valves, and blood component separation devices or centrifuges can be controlled by one or more processors included in the apheresis system 200, and can advantageously include multiple embedded computer processors as part of a computer system. The computer system can also include components that allow a user to interact with the computer system, such as including a memory and storage devices (RAM, ROM (e.g., CD-ROM, DVD), magnetic drives, optical drives, flash memory, etc.); communication / network devices (e.g., wired such as a modem / network card, or wireless such as Wi-Fi); input devices (e.g., keyboard, touch screen, camera, and / or microphone) and output devices (e.g., display and audio system), etc. To assist the operator of the apheresis system 200 in completing various aspects of its operation, embodiments of the blood component separation device or centrifuge can include a graphical user interface with a display incorporating an interactive touch screen.

[0124] The apheresis system 200 can include a housing 204 and / or a structural frame; a cover 210; access panels 224 disposed on the front 202 and / or rear 206 of the apheresis system 200; and one or more supports 232A-C (including hooks, brackets, cradles, arms, protrusions, plates) and / or other support features for holding, supporting, and / or otherwise supporting bags or containers 114, 118, 122. In some embodiments, the features of the apheresis system 200 can be described with reference to a coordinate system 103 and / or one or more of its axes. The housing 204 can include a frame (e.g., made of welded, bolted, and / or joined structural elements, extruded materials, beams, etc.) to which one or more panels, covers 210, doors, sub-assemblies, and / or components are attached. In one embodiment, at least one panel of the apheresis system 200 can 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 can include one or more handles, locks, and pivot shafts or hinge shafts 226 (e.g., door hinges, piano hinges, continuous hinges, cleanroom hinges, etc.). In any case, the access panel 224 can be selectively opened to provide access to the interior of the apheresis system 200, and more specifically, to the blood separation component or centrifuge. In one embodiment, the access panel 224 can provide a passage for loading and / or unloading one or more components in a blood component collection device. Details of the centrifuge are described in more detail herein with reference to Figures 4A - 4L to more details of the centrifuge.

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

[0127] In some embodiments, the apheresis system 200 can include a plurality of pumps 208, 212, 216 configured to control the flow of fluids (e.g., blood and / or blood components, anticoagulants, saline, etc.) through the apheresis system 200. For example, the apheresis system 200 can include a suction pump 208 that controls the flow of blood into and / or out of the donor 102 and into the centrifuge of the apheresis system 200. The suction pump 208 can engage a portion of the loop inlet tube 108B disposed between the soft cassette assembly 300 and the centrifuge of the apheresis system 200. In some embodiments, the apheresis system 200 can 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 bag 122 and / or from the plasma collection bag 122 to the centrifuge. Additionally or alternatively, the return pump 212 can control the flow of saline (e.g., supplied from the saline bag 118) in the blood component collection device and / or the apheresis system 200. The anticoagulant pump 216 can engage a portion of the anticoagulant tube 110 to selectively control the flow of anticoagulant in the blood component collection device of the apheresis system 200. As Figure 2A shown, the pumps 208, 212, 216 can be disposed at least partially on the top cover 210 of the apheresis system 200.

[0128] Figure 2B and Figure 2C illustrate different perspective views of the pumps 208, 212, 216 of the apheresis system 200 according to embodiments of the present disclosure. Although the suction pump 208 is shown and described in connection with Figure 2B and Figure 2C it should be understood that other pump assemblies of the apheresis system 200, namely the return pump 212 and the anticoagulant pump 216, can include structures that are 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 enclose the moving elements of the suction pump 208. In some embodiments, the pump cover 236 may include a hinged tube sheath 240 configured to open and close about a tube sheath pivot axis 242. In one embodiment, the tube sheath 240 may be connected to the pump cover 236 by one or more fasteners disposed along the tube sheath pivot axis 242. Figure 2B and Figure 2C As shown, blood provided by donor 102 can be delivered or aspirated into the centrifuge along a first aspiration or centrifugal direction 250A by aspiration pump 208. Additionally or alternatively, blood or other fluids can be delivered or aspirated toward donor 102 by aspiration pump 208 in a donor direction 250B opposite to centrifugal direction 250A.

[0130] In some embodiments, the suction pump 208 and / or other pumps 212, 216 can be a tube pump, a peristaltic pump, a diaphragm pump, and / or other pumps configured to control the flow of at least a portion of the fluid (e.g., blood, blood components, anticoagulants, saline, etc.) in the tube. For example, the pumps 208, 212, 216 can include a motor operably interconnected with the rotating tube contact assembly. In operation, the tube (e.g., the ring inlet tube 108B, the ring outlet tube 112, the anticoagulant tube 110, etc.) can be inserted into the tube guide 244, the tube pressure block 248, and the end tube guide 252 adjacent to the rotating tube contact head. In one embodiment, the tube pressure block 248 can be moved in a direction away from the rotating tube contact head or the pump 208, 212, 216 to provide a loading gap area, and vice versa. The rotating tube contact head can include a plurality of rotating pressure rollers 268, which are configured to rotate around respective pressure roller rotation axes 264. Each rotating pressure roller 268 may be disposed between a first rotating pump plate 272A and a second rotating pump plate 272B, wherein the plates 272A, 272B are configured to rotate about the pump rotation axis 260. In some embodiments, the rotating pressure rollers 268 may be disposed at the periphery of the rotating pump plates 272A, 272B.

[0131] One or more of the pumps 208, 212, 216 may include or operate similarly to a pump such as: Model UX-74130 peristaltic pump, Pumps of the MEC-O-MATIC series, all of which are manufactured by Pulsafeeder, Inc. of Punta Gorda, Florida, USA, but not limited thereto. Other examples of pumps 208, 212, 216 may include, but are not limited to, INTEGA DOSE IT laboratory peristaltic pumps manufactured by INTEGA Biosciences AG of Switzerland, and all WELCO WP1200, WP1100, WP1000, WPX1 and / or WPM series peristaltic pumps manufactured by WELCO Co., Ltd. of Tokyo, Japan.

[0132] Once the tube is loaded into the tube guides 244, tube pressure blocks 248, and / or end tube guides 252, at least some of the rotating pressure rollers 268 can be caused to engage, contact, or otherwise compress the tube disposed between the rotating tube contact head and the tube pressure block 248. As the rotating pump plates 272A, 272B rotate about the pump rotation axis 260, the rotating pressure rollers 268 can compress the tube portion between the pumps 208, 212, 216 and the tube pressure block 248, causing the fluid within that tube portion to move positively in specific directions 250A, 250B as the rotating pressure rollers 268 move. For example, when the rotating pump plates 272A, 272B rotate counterclockwise about the pump rotation axis 260, the rotation of the rotating pressure rollers 268 compressing the tube between the rotating pressure rollers 268 and the tube pressure block 248 can move or pump the fluid in the centrifugal direction 250A. As another example, when the rotating pump plates 272A, 272B rotate clockwise about the pump rotation axis 260, the rotation of the rotating pressure rollers 268 compressing the tube between the rotating pressure rollers 268 and the tube pressure block 248 can move or pump the fluid in the donor direction 250B. When not actively pumping, the pump 208 can be maintained in a state where at least one rotating pressure roller 268 continues to block the tube 108B or a state where no rotating pressure roller 268 blocks the tube 108B. Thus, based on the state at rest, the pump 208 can also act as a "valve" to prevent or allow fluid movement. The pumps 212 and 216 can also have this ability.

[0133] The protective sheath 240 and the pump cover 236 can be used to protect the operator (such as a phlebotomist, apheresis technician, etc.) and / or protect the blood donor 102 from accidental contact with one or more moving parts of the pumps 208, 212, 216. In one embodiment, the protective sheath 240 can be held in the closed position by one or more protective closure features 254 provided in the protective sheath 240, the tube guide 244, the tube pressure block 248, and / or the end tube guide 252. In some cases, these protective closure features 254 can be magnets included in the protective sheath 240, the tube guide 244, the tube pressure block 248, and / or the end tube guide 252. In some embodiments, when the protective sheath 240 is opened, the pumps 208, 212, 216 can be stopped or prevented from moving / operating. In this embodiment, the protective closure sensor can be included in the protective closure features 254, the guides 244, 252, and / or the tube pressure block 248.

[0134] One or more fluid control valves can be used to control the route or flow direction of the fluid conveyed through the tubes of the apheresis system 200. In some embodiments, the apheresis system 200 can include a plasma and saline valve control system 228 disposed near the saline bag 118 and / or the plasma collection bottle 122. The plasma and saline valve control system 228 is shown in Figure 2D a detailed perspective view.

[0135] As Figure 2D shown, the loop outlet tube 112 can flow through the return pump 212 and be interconnected with the saline and plasma tube Y-connector 280. The saline and plasma tube Y-connector 280 can allow the loop outlet tube 112 to be connected to the saline tube 116 line and the plasma tube 120 line. The plasma and saline valve control system 228 can include an air detection sensor 284 disposed at the first end of the saline and plasma valve housing 276 and around a portion of the loop outlet tube 112. The air detection sensor 284 can be any optical, ultrasonic, or other type of sensor capable of detecting the presence of fluid or air in the loop outlet tube 112 and providing the signal to the controller of the apheresis system 200. The type of the air detection sensor 284 can include, for example, SONOCHECK ABD05 manufactured by SONOTEC US Inc. or another similar sensor.

[0136] The saline and plasma valve housing 276 may include a plurality of receiving features (e.g., grooves, channels, containers, etc.) that receive a portion of the tubes 112, 116, 120 and / or the saline and plasma tube Y-connector 280. Once air is detected in the loop outlet tube 112, the plasma and saline valve control system 228 may selectively actuate one or more of the fluid control valves 286, 288. In some embodiments, air detection via the air detection sensor 284 may be used to signal an operating step and / or trigger a step in the control methods described 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 clamping valve, a tube valve, and / or other actuatable valves configured to selectively alter, for example, block a fluid passage associated with a particular portion of the tubes 112, 116, 120. As Figure 2D shown, the plasma flow control valve 286 may be configured to clamp a portion of the plasma tube 120 that is at least partially received within the receiving features of the saline and plasma valve housing 276. The saline flow control valve 288 may be configured to clamp a portion of the saline tube 116 that is at least partially received within the receiving features of the saline and plasma valve housing 276. In any case, the control valves 286, 288 may include actuatable extendable fingers that move from a retracted or partially retracted position to an extended or partially extended position to clamp a portion of the tube contained within the saline and plasma valve housing 276. While the control valves 286, 288 may fully clamp the tube (e.g., completely restrict fluid flow through the tube), it should be understood that the control valves 286, 288 may be actuated partially to a position that partially restricts fluid flow through a portion of the tube.

[0138] Now referring Figure 3A , a detailed perspective view of a disposable soft cassette assembly 300 in accordance with an embodiment of the present disclosure is shown. The soft cassette assembly 300 may include a base plate and a cassette access door 304 that is attached to the base plate by at least one hinge and / or cassette access door latch 308. In some embodiments, the cassette access door 304 may be unlocked by actuating the cassette access door latch 308 and pivoted about the cassette access door hinge axis 306. The soft cassette assembly 300 may be configured with one or more soft cassette receiving features 324 for at least partially receiving and / or positioning the soft cassette 340 therein. The soft cassette 340 may be part of the blood component collection device described herein. For example, the soft cassette 340 may be disposed between the cassette inlet tube 108A and the loop inlet tube 108B of the extracorporeal tubing. In some embodiments, the soft cassette 340 may provide one or more features for controlling the flow of blood and / or blood components from the donor 102 to the apheresis system 200 and / or from the apheresis system 200 to the donor 102.

[0139] The soft cartridge assembly 300 can include an air detection sensor 312, a fluid sensor 316, and one or more fluid control valves 320A-C configured to control the fluid path or flow direction through the soft cartridge 340. In some embodiments, these components can be embedded in a portion of the cartridge access door 304, the substrate, and / or the housing 204 of the apheresis system 200. Similar to the protective closure feature 254 described in connection with Figures 2B to 2C the soft cartridge assembly 300 can include one or more door closure features 328. These features 328 can include, but are not limited to, magnetic clips, protrusions, tabs, and slots and / or other connectors. In one embodiment, the door closure feature 328 can include a pressure contact surface configured to hold the soft cartridge 340 or at least partially position the soft cartridge 340 within the soft cartridge assembly 300.

[0140] Examples of valves 320A-C can include, but are not limited to, solenoid valves, linear actuators, pinch valves, clamping valves, tube valves, and / or other actuatable valves configured to selectively change, e.g., block, a fluid passage (e.g., cross-sectional area, etc.) associated with a particular portion of the soft cartridge 340. The soft cartridge assembly 300 can include a first fluid control valve 320A configured to clamp a portion of the soft cartridge 340 near the cartridge inlet tube 108A. A second fluid control valve 320B can be configured to clamp a portion of the soft cartridge 340 adjacent to the loop inlet tube 108B. A suction fluid control valve 320C can be configured to clamp a portion of the soft cartridge 340 along a branch tube that extends from a point adjacent to the cartridge inlet tube 108A to a point adjacent to the loop inlet tube 108B. In any case, valves 320A-C can include actuatable extendable fingers that move from a retracted or partially retracted position to an extended or partially extended position to clamp a portion of the soft cartridge 340 contained within the soft cartridge assembly 300. Although valves 320A-C can fully clamp the flow path in the soft cartridge 340 (e.g., completely restrict fluid flow therethrough), it should be understood that valves 320A-C can be actuated partially to a position that partially restricts fluid flow through a portion of the soft cartridge 340.

[0141] The sensors 312, 316 can be one or more of an ultrasonic detector, a pressure sensor, a magnetic position sensor, etc. In some cases, the fluid sensor 316 can determine whether there is fluid in the soft cartridge 340 based on the position of a magnet relative to a portion of the soft cartridge 340. For example, when a portion of the soft cartridge 340 is filled with fluid, the magnet can be set at a first position from the surface of the soft cartridge 340. On the other hand, when a portion of the soft cartridge 340 is filled with air, the force from the magnet can compress a portion of the soft cartridge 340 to a second position closer to the surface of the soft cartridge 340 than the first position. In any case, air detection or fluid detection via the air detection sensor 312 and the fluid sensor 316 respectively can be used to signal operation steps and / or trigger steps in the control method as described herein.

[0142] Figures 3B to 3D Different views of the soft cartridge 340 according to embodiments of the present disclosure are shown. As described above, the soft cartridge 340 can be part of a blood component collection device. For example, the soft cartridge 340 can be a disposable component used in the blood separation method described herein. In some embodiments, the soft cartridge 340 can be made of a substantially compliant and / or flexible material. The compliant material can be chemically inert and / or capable of withstanding disinfection and cleaning operations, temperature, and / or handling. The soft cartridge 340 can be made of polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene vinyl acetate (EVA), rubber, silicone, thermoplastic, thermoplastic elastomer, polymer, copolymer, and / or combinations thereof. In some embodiments, the soft cartridge 340 can be molded, rotomolded, cast, injection molded, or otherwise formed from one or more of the above materials.

[0143] The soft cartridge 340 can include a first cartridge port 360A, a second cartridge port 360B, and a direct flow lumen 370 extending between the first and second cartridge ports 360A - B. In some embodiments, the first and / or second cartridge ports 360A - B can be configured to receive one or more tubes of the blood component collection device and / or be in fluid connection with one or more tubes of the blood component collection device. For example, the first cartridge port 360A can be coupled to the cartridge inlet tube 108A, and the second cartridge port 360B can be coupled to the loop inlet tube 108B. These couplings can be airtight and / or liquidtight. In one embodiment, the first and / or second cartridge ports 360A - B can include a hole disposed within the soft cartridge 340 that is configured to elastically stretch around the end of a tube (e.g., the cartridge inlet tube 108A, the loop inlet tube 108B, etc.).

[0144] Blood supplied by the blood donor 102 can be directed along one or more fluid paths disposed within the flexible cassette 340. In one embodiment, the blood can be directed from the first cassette port 360A to the second cassette port 360B along the direct flow lumen 370. In some embodiments, the flow path can direct the blood through the drip chamber 354 of the flexible cassette 340. In some embodiments, blood and / or other fluid returning to the blood donor 102 can be directed from the second cassette port 360B to the first cassette port 360A along the direct flow lumen 370.

[0145] The flexible cassette 340 can include a fluid flow bypass path provided by the first bypass branch 358A having a bypass flow lumen 364 that is fluidly connected to a portion of the direct flow lumen 370 adjacent to the first cassette port 360A or as part of the first cassette port 360A. In some embodiments, the bypass flow lumen 364 can begin at a point on the direct flow lumen 370 adjacent to the first cassette port 360A, follow the first bypass branch 358A, pass through the fluid pressure loop 362 to the second bypass branch 358B, and then reconnect to the direct flow lumen 370 at a point adjacent to the second cassette port 360B or as part of the second cassette port 360B. As the name implies, the bypass flow lumen 364 provides a flow path within the flexible cassette 340 that bypasses the drip chamber 354.

[0146] Controlling the flow path within the flexible cassette 340 or directing fluid within the flexible cassette 340 may include actuating the fluid control valves 320A-C of the flexible cassette assembly 300 to interact with different compliant regions 350A-C that block and / or open the direct flow lumen 370 and / or the bypass flow lumen 364. The first compliant region 350A provides a pinch valve region at a point along the direct flow lumen 370 between the first cassette port 360A and the drip chamber 354 near the first cassette end 342 of the flexible cassette 340. When the first fluid control valve 320A is actuated, the valve 320A can pinch closed the direct flow lumen 370 at this first compliant region 350A, restricting or completely preventing fluid flow at this point in the flexible cassette 340. The second compliant region 350B provides a pinch valve region at a point along the direct flow lumen 370 between the second cassette port 360B and the drip chamber 354 near the second cassette end 346 (e.g., opposite the first cassette end 342). When the second fluid control valve 320B is actuated, the valve 320B can pinch closed the direct flow lumen 370 at this second compliant region 350B, restricting or completely preventing fluid flow at this point in the flexible cassette 340. It will be appreciated that the third compliant region 350C disposed along the first bypass branch 358A adjacent to the fluid pressure loop 362 can provide a pinch valve region at a point along the bypass flow lumen 364. When the aspiration fluid control valve 320C is actuated, the valve 320C can pinch closed the bypass flow lumen 364 at this third compliant region 350C, restricting or completely preventing fluid from flowing through the bypass flow lumen 364.

[0147] As shown in the elevation cross-sectional view taken along a plane passing through the direct flow lumen 370 and the drip chamber 354, the direct 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 direct flow lumen 370 can be formed as a fluid passage extending inside the first tube section 368A, the inner chamber volume 374, and the second tube section 368B of the flexible cassette 340. Figure 3C

[0148] Figure 3D In some embodiments, the bypass path of the flexible cassette 340 may include a fluid pressure loop 362 through which fluid can flow from the first bypass branch 358A to the second bypass branch 358B, and / or from the second bypass branch 358B to the first bypass branch 358A. In one embodiment, a pressure diaphragm 380 can be formed in a region within or near the fluid pressure loop 362 in the material of the flexible cassette 340. The fluid pressure loop 362 and the pressure diaphragm 380 are in Figure 3Dis shown in a cross-sectional elevation view taken through a plane passing through the fluid pressure ring 362 and portions of the first and second bypass branches 358A - B. The pressure diaphragm 380 may provide a contact or measurement surface for the fluid sensor 316 to detect whether the fluid pressure ring 362 and / or the bypass flow lumen 364 includes a certain amount of fluid, air, and / or a combination thereof. As provided above, when a portion of the fluid pressure ring 362 is filled with fluid, the fluid may provide a greater resistance to movement than when the fluid pressure ring 362 is filled with air. This difference in resistance may be measured by the fluid sensor 316 to specifically determine the amount and / or type (e.g., air, blood, etc.) of fluid in the bypass flow lumen 364 and / or the fluid pressure ring 362.

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

[0150] The centrifuge assembly 400 may be operably mounted within the apheresis system 200 such that the assembly 400 is capable of rotating 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 portions of the blood component collection device by routing tubes (e.g., the loop inlet tube 108B and the loop outlet tube 112, etc.) into the interior space of the apheresis system 200 (e.g., through Figure 2A the opening 220 shown), connecting a portion of the blood component collection loop 520 to the fixed loop connector 402, and inserting the blood component collection bladder 536 into the filler 460. The fixed loop connector 402 holds the loop inlet tube 108B and the loop outlet tube 112 in a fixed position and may prevent the tubes 108B, 112 outside the apheresis system 200 from twisting. In some embodiments, the blood component collection loop 520 may be interconnected with the fixed loop connector 402 by one or more key features or rigid positioning features.

[0151] For clarity of description, Figures 4B to 4CShows different perspective views of the centrifuge assembly 400 separated from the apheresis system 200. The centrifuge assembly 400 can include a centrifuge split housing 404, and the centrifuge split housing 404 includes a lower housing 404A pivotally connected to an upper housing 404B. The upper housing 404B can be opened to provide access for loading components such as a blood component collection bag or other components of the blood component collection device into the centrifuge assembly 400. In some embodiments, the upper housing 404B can pivot about a split housing pivot axis 406 (e.g., configured as a hinge, pin, fastener, shoulder bolt, etc.).

[0152] Different halves of the centrifuge split housing 404 (e.g., the lower housing 404A and the upper housing 404B) can be configured to lock and / or unlock together. Unlocking the upper housing 404B from the lower housing 404A can 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 a centrifuge rotation axis 430. Although the centrifuge split housing 404 is shown in Figures 4B to 4C an unlocked state, it should be understood that the upper housing 404B can be rotated (e.g., in a counterclockwise direction) about the centrifuge rotation axis 430 to engage one or more locking tabs 428 or elements of the upper housing 404B with locking slots 432 provided in the lower housing 404A (as Figure 4C shown). When in the unlocked position, the upper housing 404B can be opened or pivoted about the split housing pivot axis 406 to load a blood component collection loop 520 and / or a blood component collection bag 536 into the centrifuge assembly 400. When in the locked position, the upper housing 404B is rotationally locked relative to the lower housing 404A, and the two halves of the centrifuge split housing 404 can rotate together and be locked together during centrifugation or during a blood separation operation.

[0153] The centrifuge assembly 400 can include at least one clockwise rotation stopper 408A, a counterclockwise rotation stopper 408B, an upper housing clockwise rotation mark 410A, and / or an upper housing counterclockwise rotation mark 410B. In some embodiments, the rotation stoppers 408A, 408B can be rotatably fixed relative to the centrifuge rotation axis 430 of the lower housing 404A. The rotation marks 410A, 410B can be attached or formed in the upper housing 404B and are configured to contact the corresponding rotation stoppers 408A, 408B to prevent the upper housing 404B from over-rotating relative to the lower housing 404A when locking and / or unlocking the two halves of the centrifuge split housing 404 together. For example, when rotating the upper housing 404B about the centrifuge rotation axis 430 in a clockwise (or unlocking) direction, a portion of the upper housing clockwise rotation mark 410A can contact the clockwise rotation stopper 408A to prevent further rotation in the clockwise direction. Additionally or alternatively, when rotating the upper housing 404B about the centrifuge rotation axis 430 in a counterclockwise or locking direction, a portion of the upper housing counterclockwise rotation mark 410B can contact the counterclockwise rotation stopper 408B to prevent further rotation in the counterclockwise direction. In some embodiments, the centrifuge split housing 404 can include one or more locking elements configured to hold the two halves of the centrifuge split housing 404 in a locked state when the locking elements are engaged.

[0154] In one embodiment, the centrifuge split housing 404 can include a pull tab 412 attached to a portion of the upper housing 404B to pivot the upper housing 404B relative to the lower housing 404A about the split housing pivot axis 406. The pull tab 412 can provide a hole through which a user can insert a finger and apply a pulling force to the rotationally unlocked upper housing 404B.

[0155] The centrifuge assembly 400 can include a rotor and a motor assembly 414 that is controlled and / or powered by an electronic interconnect cable 420. The cable 420 can include connections to a controller, a processor, and / or a power source. The cable 420 can convey electrical 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 can be configured as an electric motor and / or a portion of an electric motor that rotates the entire centrifuge assembly 400 relative to the apheresis system 200 (e.g., relative to a portion of the housing 204 and / or the base of the apheresis system 200). In other words, the rotor and motor assembly 414 can include one or more components that cause the centrifuge assembly 400 (e.g., the two halves of the centrifuge split housing 404 together) to rotate within the apheresis system 200.

[0156] As described herein, the centrifuge assembly 400 can include one or more features to guide, house, and / or position elements of a blood component collection device relative to the centrifuge split housing 404. For example, in Figure 4B , the blood component collection loop 520 is shown captured in an operating position within a loop rotation position guide 424 that includes a loop capture arm 416. The loop rotation position guide 424 can include a plurality of bearings 417 and / or bearing surfaces that are arranged to at least partially support the blood component collection loop 520 in the operating position. In the operating position, the blood component collection loop 520 can twist along its length within the support provided by the bearings 417 of the loop rotation position guide 424. For example, one end of the blood component collection loop 520 can be fixedly attached to a fixed loop connector 402 of the apheresis system 200, while the other end of the blood component collection loop 520 can be connected to a filler 460 (e.g., an internal rotating component of the centrifuge assembly 400). When the centrifuge assembly 400 rotates during a centrifugation operation, the twisting of the blood component collection loop 520 between the connectors at the fixed loop connector 402 and the filler 460 can cause the filler 460 to rotate relative to the centrifuge split housing 404 of the centrifuge assembly 400. In one embodiment, when the centrifuge assembly 400 rotates within the apheresis system 200, the low inertia of the filler 460 combined with the twisting of the blood component collection loop 520 can cause the filler 460 to rotate at an angular velocity that is twice that of the centrifuge split housing 404 in the same direction of rotation. In this example, when the centrifuge split housing 404 rotates counterclockwise about the centrifuge rotation axis 430 at a first angular velocity 1ω, the filler 460 can rotate counterclockwise within the centrifuge split housing 404 at a second angular velocity 2ω (e.g., substantially twice the first angular velocity, etc.).

[0157] The centrifuge assembly 400 can include one or more balance features, elements, and / or structures disposed about the centrifuge rotation axis 430 of the centrifuge assembly 400. These balance features can provide an axially balanced centrifuge assembly 400 such that when rotated about the centrifuge rotation axis 430, the centrifuge assembly 400 can substantially not impose vibrations on the apheresis system 200. In one embodiment, a centrifuge counterweight 418 can be attached to a portion of the centrifuge split housing 404 (e.g., the lower housing 404A and / or the upper housing 404B, etc.). The centrifuge counterweight 418 can be customized for the centrifuge assembly 400 and thus can be selectively attached to and removed from the centrifuge assembly 400. The adjustment of the centrifuge counterweight 418 can be calculated and / or determined empirically to produce a fully balanced centrifuge assembly 400, particularly when one or more elements of the blood component collection device are loaded.

[0158] Figure 4C Shows a rear perspective view of a centrifuge assembly 400 according to an embodiment of the present disclosure. A portion of the filler 460 is visible through a hole in the upper housing 404B. The blood component collection ring 520 is shown in an initial ring loading position 520A, where a first end is interconnected with the filler 460 and a second end is fixedly attached to a fixed ring connector 402 (not shown). The blood component collection ring 520 is shown passing through a ring entry gap 436 in the centrifuge split housing 404. When the blood component collection ring 520 is loaded in the ring loading position 520A, a portion of the blood component collection ring 520 can be partially received, held, and / or supported by the ring receiving bracket 426. The ring receiving bracket 426 can include one or more bearings 417 (e.g., roller bearings, ball bearings, needle bearings, etc. and / or assemblies thereof) or support surfaces that are arranged to at least partially support the blood component collection ring 520 when the blood component collection ring 520 is twisted relative to the centrifuge assembly 400. In some embodiments, the blood component collection ring 520 can rotate about an axis extending along the length of the flexible ring 524 (e.g., in an installed or mounted condition and / or state, etc.) to allow relative rotational movement of the flexible ring 524 relative to the ring rotation position guide 424. For example, the ring is not "twisted", but rather rotates or rolls relative to the ring rotation position guide 424 (e.g., a support structure) between one or more bearings 417. This rotation or twisting without binding or twisting the flexible ring 524 can be referred to herein as torsion. This torsion enables the flexible ring 524 to transmit rotational force to the filler 460 without significantly reducing the inner diameter of the lumen of the flexible ring 524. In some cases, the inner diameter of the lumen of the flexible ring 524 does not decrease.

[0159] As described above, when the upper housing 404B rotates from Figures 4B to 4C the rotation unlock position shown to the rotation lock position, the locking tab 428 of the upper housing 404B can engage with the locking slot 432 in the lower housing 404A. Additionally or alternatively, when moved to the rotation lock position, the ring receiving bracket 426 can rotate to a position in alignment with the ring rotation position guide 424 along the ring engagement position 520B together with the blood component collection ring 520 and the upper housing 404B. In some embodiments, when the upper housing 404B and the blood component collection ring 520 rotate to the ring engagement position 520B, the ring capture arm 416 can guide the blood component collection ring 520 into the bearings 417 and / or bearing surfaces of the ring rotation position guide 424. More details regarding the loading of the blood component collection ring 520 are described in Figures 6A to 7B connection.

[0160] Figures 4D to 4FShows different schematic cross-sectional views taken through the center of the centrifuge assembly 400 (e.g., bisecting the centrifuge assembly 400 along 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 axis 406 or hinge. The upper housing 404B may be attached to an upper housing adapter 440 that is rotationally interconnected to an upper housing bushing block 442 attached to a pull ring 412. In one embodiment, a bearing 417, bushing, or bearing surface may be provided between the upper housing adapter 440 and the upper housing bushing block 442 such that the upper housing 404B can rotate along the centrifuge rotation axis 430 from a locked position to an unlocked position, or from an unlocked position to a locked position. The pull ring 412 may be rotationally fixed relative to the lower housing 404A about the centrifuge rotation axis 430. In some embodiments, the upper housing adapter 440 and the upper housing 404B may be formed of an integral structure.

[0161] The filler 460 may be fixedly attached to a filler mandrel 434 that is configured to rotate about the centrifuge rotation axis 430 relative to the upper housing 404B. In one embodiment, the filler mandrel 434 may be formed as part of the filler 460. In any case, one or more mandrel support bearings 444 may be provided between the filler mandrel 434 and the upper housing adapter 440 such that the filler 460 can rotate about the centrifuge rotation axis 430 within the centrifuge split housing 404 and the centrifuge assembly 400. In some embodiments, the filler mandrel 434 may be held in an operating position by at least one retaining nut 438. The filler 460 and the filler mandrel 434 may rotate together relative to the centrifuge split housing 404.

[0162] Figure 4D Shows a schematic cross-sectional view of the centrifuge assembly 400 in a closed state (e.g., before loading the blood component collection loop 520) according to an embodiment 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 pivot the entire upper housing 404B and the filler 460 about the split housing pivot axis 406. In one embodiment, the upper housing 404B and the filler 460 may be partially opened by pivoting the components about the split housing pivot axis 406 in an open direction 446 as shown. As Figure 4E shown, and pivot about the split housing pivot axis 406 in the open direction 446. As Figure 4EAs shown, the centrifuge assembly 400 is shown in a partially open state, with the upper housing 404B and the filler 460 rotating outward about the lower housing rotation axis 430A about the axis. In this position, the filler 460 can be allowed to rotate about the filler rotation axis 430B. When the lower housing 404A and the upper housing 404B are in the closed state, the lower housing rotation axis 430A and the filler rotation axis 430B are aligned (coincide or substantially coincide) to form the centrifuge rotation axis 430.

[0163] Continuing to rotate the upper housing 404B and the filler 460 in the opening direction 446 about the Y-axis of the split housing pivot axis 406 (e.g., by continuing to pull the pull tab 412) can cause the upper housing 404B and the filler 460 to pivot approximately 180 degrees from Figure 4D the closed position shown. As Figure 4F shown, the centrifuge assembly 400 is in the open or loading state. In this position, the upper housing 404B and the filler 460 can pivot outside the internal space of the apheresis system 200. For example, at least a portion of the filler 460 and / or the upper housing 404B can be arranged to pass through the open space of the open access panel 224. In this position, a loading access area 450 can be provided to the loop connection area 454 of the filler 460. It can be understood that orienting the upper housing 404B in the open position provides easy access to the interior of the upper housing 404B and the filler 460. Among them, this arrangement can provide sufficient clearance for the operator to connect the blood component collection loop 520 to the filler 460 at the loop connection area 454.

[0164] Referring to Figure 4G , a perspective view of the filler 460 of the centrifuge assembly 400 according to an embodiment of the present disclosure is shown. In some embodiments, the filler 460 can be made of a lightweight material such as plastic, carbon fiber, aluminum, etc. In one embodiment, the filler 460 can be 3D printed by a three-dimensional (3D) printer. For example, the filler 460 can be produced by additive manufacturing techniques or systems (such as fused deposition modeling (FDM), selective laser sintering (SLS), stereolithography (SLA), and / or other additive manufacturing machines). Among them, these additive rapid prototyping techniques can enable the filler 460 to have a more complex geometry, which is impossible in the use of traditional machining or manufacturing processes. In some embodiments, the material of the filler 460 can be selected based on the desired quality of the filler 460, the desired physical strength of the manufactured filler 460, and / or the appropriate materials used in manufacturing.

[0165] The filler 460 may include an annular connection region 454 disposed substantially at the center of the filler 460. The annular connection region 454 may include one or more keys or rigid locator features for engagement with a portion of the blood component collection loop 520. As Figure 4G shown, the annular connection region 454 includes a first rigid locator feature 478 disposed along a portion of the central axis of the filler 460. The first rigid locator feature 478 may be a keyway, groove, slot, or other feature for engagement with a mating feature disposed on the blood component collection loop 520. In some embodiments, the filler 460 may include a second rigid locator feature 480 in the annular connection region 454. The locator features 478, 480 may prevent the blood component collection loop 520 from rotating at the annular connection region 454 and / or prevent the blood component collection loop 520 from disengaging from the annular connection region 454 of the filler 460.

[0166] In some embodiments, the filler 460 may include a collection insertion channel 466 configured to receive and at least partially accommodate the blood component collection bladder of the blood component collection device, and more specifically, the blood component collection loop 520. The collection insertion channel 466 may be configured as a groove, slot that extends outwardly from the center of the filler 460 in a generally helical manner. In some embodiments, the collection insertion channel 466 may follow a generally helical path that may include a first helical path portion that extends outwardly from the center of the filler 460 to a substantially constant radius (e.g., around the center of the filler 460) along the length of the periphery of the collection insertion channel 466. In any case, the path may be referred to herein as a helical path or a generally helical path. The collection insertion channel 466 may start at a channel inlet 468 adjacent the center of the filler body 464 and terminate at a channel end 472 adjacent the point furthest from the center of the filler body 464. As Figures 4G to 4IAs shown, the collection insertion channel 466 can extend along a generally helical path 490 that extends from a point adjacent to the filler rotation axis 430B to the channel end 472. The generally helical path 490 can include a channel path protrusion 476 at a point near or adjacent to the channel end 472. The channel path protrusion 476 can extend the distance of the collection insertion channel 466 from the center of the filler body 464, thereby increasing the centripetal and centrifugal forces at the channel end 472 of the collection insertion channel 466. In one embodiment, the channel path protrusion 476 can correspond to a critical inlet and outlet at the radial maximum within the blood component collection bladder 536, which is at least partially inserted or disposed within the collection insertion channel 466 of the filler 460. In some embodiments, the filler 460 can include one or more filler balance protrusions 482 disposed on, within, or around a portion of the filler body 464. These filler balance protrusions 482 can provide axial balance (e.g., about the filler rotation axis 430B) to the filler 460, especially when the collection insertion channel 466 includes a blood component collection bladder and fluid (e.g., blood, blood components, etc.).

[0167] Figure 4I is a schematic plan view of a generally helical receiving channel or collection insertion channel 466 for a filler 460 according to an embodiment of the present disclosure. The schematic plan view shows a first distance R1 of the collection insertion channel 466 from the center of the filler body 464 (e.g., adjacent to the filler rotation axis 430B, etc.) at a first point along the generally helical path 490, and a second distance R2 of the collection insertion channel 466 from the center of the filler body 464 at a point passing adjacent to the channel path protrusion 476. As Figure 4I shown, the second distance R2 is farther from the center of the filler body 464 than the first distance R1. This increase in distance can provide higher centripetal and centrifugal forces in the channel near or at the channel end 472 than at any other point along the generally helical path 490. In some embodiments, the end of the blood collection bladder can substantially coincide with the channel end 472, thereby providing maximum blood separation force at the end of the bladder.

[0168] Figures 4J to 4LShows different elevation cross-sectional views of the filler 460, and more specifically, shows an elevation cross-sectional view of the collection insertion channel 466 and the filler insertion chamber 492 disposed inside the filler body 464. In some embodiments, the collection insertion channel 466 may include a cross-section or shape that generally follows a substantially helical path 490 in the filler body 464. The collection insertion channel 466 may include an insertion groove configured to receive a substantially flat or unfilled blood component collection bladder. The blood component collection bladder may be inserted into the collection insertion channel 466 and the filler insertion chamber 492 formed in the filler body 464 along the substantially helical path 490. The filler insertion chamber 492 may be defined by one or more sidewalls 494, 496 that form a cavity following the substantially helical path 490. As Figure 4K shown, the filler insertion chamber 492 includes an inner chamber wall 494 spaced apart from at least one outer chamber wall 496. The filler insertion chamber 492 may be formed in the filler 460 by 3D printing the filler 460 and / or by some other metal or plastic forming operation or operations (such as casting, molding, shaping, etc.). In some embodiments, the filler insertion chamber 492 may include one or more insertion guiding features 498. These insertion guiding features 498 may be configured to guide, position, and / or seat the blood component collection bladder within the filler insertion chamber 492 of the filler 460. Although shown as a chamfer or lead-in feature of the filler insertion chamber 492, the insertion guiding features 498 may include one or more radii, chamfers, bevels, tapers, draft angles, receptacles, grooves, and / or other shaped materials configured to guide and / or orient a portion of the inserted blood component collection bladder.

[0169] Figure 4LIllustrates different states of a fluid collection bladder (e.g., a blood component collection bladder, etc.) disposed within the collection insertion channel 466 and the filler insertion chamber 492 of the filler 460. As described above, the blood component collection bladder can be inserted into the collection insertion channel 466 in a substantially flat or unfilled state S1. In the substantially flat state S1, the size of the blood component collection bladder can be set to enter the upper opening of the collection insertion channel 466 and remain in a pre-filled state within the filler insertion chamber 492. When the filler 460 begins to rotate and separate blood components from the blood provided by the blood donor 102, the blood component collection bladder can expand from the substantially flat first state S1 to an expanded or filled state S2. In some embodiments, the blood component collection bladder can expand with blood and / or blood components until the walls of the blood component collection bladder contact the walls 494, 496 of the filler insertion chamber 492. In one embodiment, the shape of the filler insertion chamber 492 can be designed to optimize the amount of fluid that can be collected and / or separated within the filler insertion chamber 492 (e.g., maximize the amount of fluid while minimizing the amount of material of the filler 460).

[0170] Figure 5A Illustrates a schematic diagram of a blood component collection device 500 according to an embodiment of the present disclosure. The blood component collection device 500 can include tubes (e.g., one or more of the blood donor supply tube 104, cassette inlet tube 108A, loop inlet tube 108B, anticoagulant tube 110, loop outlet tube 112, saline tube 116, plasma tube 120, etc.); connectors (e.g., one or more of the tube connector 106, saline and plasma tube Y-connector 280, tube fittings 504, tube fittings 508, bag needle fittings 512, etc.); a soft cassette 340; and a blood component collection loop 520.

[0171] The tube can include any tube having a central lumen configured to convey fluid therethrough. The tube can be made of polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene vinyl acetate (EVA), rubber, polymers, copolymers, and / or combinations thereof. The connectors can be configured to be fluidly interconnected with the tubes (e.g., at one or more ends of the tubes, etc.). The connectors can be inserted into the central lumen of the tubes and / or attached to the exterior of the tubes. In some embodiments, the connectors can be configured with various fittings (e.g., Luer fittings, twist connectors, and / or other small-bore couplings, etc.) to provide a universal and / or reliable interconnection with one or more other fittings, connectors, tubes, needles, and / or medical accessories. In one embodiment, the bag needle fitting 512 can be configured to be inserted into a receiving bag (e.g., saline bag 118, etc.).

[0172] The blood component collection loop 520 may include a flexible loop 524 disposed between the system static loop connector 528 and the filler loop connector 532. The flexible loop 524 may be configured as a hollow flexible tube configured to receive and / or contain at least a portion of the loop inlet tube 108B and the loop outlet tube 112. In some embodiments, the flexible loop 524 may be made of a thermoplastic elastomer having enhanced flexibility for transmitting torque from one end of the flexible loop 524 to the other end. These types of elastomers may provide the flexibility of rubber while maintaining the strength and torque characteristics of plastics. Examples of thermoplastic elastomers may include, but are not limited to, copolyesters, DuPont TM (DuPont TM ) thermoplastic elastomers, Eastman Neostar TM (Eastman Neostar TM ) elastomers, Celanese (Celanese ) elastomers, TOYOBO (TOYOBO ) and / or other brands of elastomers that provide high flexibility and strength characteristics.

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

[0174] Combined Figure 5BThe elevation view illustrates details of the blood component collection loop 520. The blood component collection loop 520 can include a flexible loop 524 configured as a tube that includes a first path for the loop inlet tube 108B and a second path for the loop outlet tube 112. In some embodiments, the loop inlet tube 108B can pass through the flexible loop 524 and be interconnected with the first collection flow chamber 544 at the bladder loop end 540A via a filler loop connector 532. Additionally or alternatively, the loop outlet tube 112 can pass through the flexible loop 524 and be interconnected with the second collection flow chamber 552 at the bladder loop end 540A via the filler loop connector 532. The first path is separated from the second path. This configuration enables blood to enter the flexible loop 524 and the blood component collection bladder 536 via the first collection flow chamber 544 and be separated into one or more blood components, which can then be conveyed along the second collection flow chamber 552 to the loop outlet tube 112 in the flexible loop 524.

[0175] The first collection flow chamber 544 can be separated from the second collection flow chamber 552 by a flow chamber separator 542. The flow chamber separator 542 can be a heat-sealed portion of the blood component collection bladder 536. For example, the blood component collection bladder 536 can be made of material layers that overlap each other along the length of the blood component collection bladder 536. These material layers can be shaped (e.g., cut or otherwise shaped, etc.) and heat-sealed along one or more edges forming a fluid container. The flow chamber separator 542 can be formed in the fluid container by heat-sealing one material layer to another along a path generally as shown. The flow chamber separator 542 does not extend the entire length of the blood component collection bladder 536, thereby providing a flow chamber transition 548 to enable fluid (e.g., blood, blood components, etc.) to flow from the first collection flow chamber 544 to the second collection flow chamber 552 and / or from the second collection flow chamber 552 to the first collection flow chamber 554. In one embodiment, the fluid (e.g., blood and / or blood components, etc.) in the blood component collection bladder 536 contained in the filler insertion chamber 492 of the filler 460 can travel along the first collection flow chamber 544 in a direction toward the bladder free end 540B around one end of the flow chamber separator 542 (e.g., along the blood component movement direction 546) and enter the second collection flow chamber 552. In this example, the blood component (e.g., plasma, etc.) can be pressed back to the center of the filler body 464 (e.g., to the plasma collection bottle 122) along a generally helical path 490 along the second collection flow chamber 552 and through the loop outlet tube 112.

[0176] The blood component collection bladder 536 can be made of polyvinyl chloride (PVC), plasticized PVC, polyethylene, ethylene vinyl acetate (EVA), thermoplastics, thermoplastic elastomers, polymers, copolymers, and / or combinations thereof. In some embodiments, the blood component collection bladder 536 can be formed by heat sealing of multi-layer materials, heat sealing of a single-layer material folded onto itself, and / or combinations thereof.

[0177] In some embodiments, the blood component collection loop 520 can include a plurality of rigid positioning members or key features 530A, 530B configured to rigidly position portions of the blood component collection loop 520 relative to the apheresis system 200 and / or the filler 460. For example, the blood component collection loop 520 includes a first connection positioning feature 530A on the system static loop connector 528 and a second connection positioning feature 530B on the filler loop connector 532. The features 530A, 530B can be configured as keys, protrusions, and / or other material protrusions extending from the connectors 528, 532. In some embodiments, the second connection positioning feature 530B can include features that interconnect or mate with a first rigid positioning feature 478 and / or a second rigid positioning feature 480 of the loop connection region 454 in the filler 460. Similarly, if not identical, the rigid positioning member features can be associated with or included in the fixed loop connector 402 of the apheresis system 200.

[0178] Figure 5C and Figure 5D A cross-section of the blood component collection bladder 536 of the blood component collection loop 520 according to an embodiment of the present disclosure is shown. For example, the cross-section shows a first collection flow chamber 544 separated from a second collection flow chamber 552 along the length of the blood component collection bladder 536. In some embodiments, the separation can be provided by a flow chamber separator 542 disposed between the first collection flow chamber 544 and the second collection flow chamber 552. The flow chamber separator 542 can correspond to a sealed area of the blood component collection bladder 536. The flow chamber separator 542 can be formed as a heat-sealed area of material, such as a heat-sealed area that joins the bladder first-side material 536A to the bladder second-side material 536B. In some cases, the bladder first-side material 536A and the bladder second-side material 536B can be a single piece of material folded at an edge (e.g., adjacent to an area in the upper bladder seal 554A region or the lower bladder seal 554B region).

[0179] Figure 5D The cross-section shown in can correspond to the blood component collection bladder 536 before sealing, and Figure 5CThe cross-section shown in Figure 4L may correspond to the blood component collection bladder 536 after the upper bladder seal 554A, the lower bladder seal 554B, and / or the flow chamber divider 542 are formed or sealed (e.g., welding the bladder first side material 536A to the bladder second side material 536B, etc.). Once formed, the width WB of the bladder may correspond to the width of the first collection flow chamber 544 and / or the second collection flow chamber 552 in the unexpanded state S1 (e.g., see Figure 5C ). During operation, when at least a portion of the blood component collection bladder 536 is filled with fluid, the dimension of the width WB of the bladder may increase from the dimension shown in

[0180] Figures 5E to 5H Various perspective views of the blood component collection loop 520 in a bent state are shown (e.g., Figures 5E to 5F ), and a view of the bent blood component collection bladder 536 of the blood component collection loop 520 inserted into the filler 460 is shown (e.g., Figures 5G to 5H ). Different components of the blood component collection loop 520 may be flexible and / or capable of being formed or shaped by applying a force. In some embodiments, such flexibility may be elastic such that forming the different parts of the blood component collection loop 520 does not permanently deform the components. Figure 5E A blood component collection loop 520 in a bent state according to an embodiment of the present disclosure is shown. For example, the flexible loop 524 is shown to be elastically bent along its length, and the blood component collection bladder 536 is shown to follow a plurality of bends or curves along its length. When the components are in the bent state, the flexible loop 524 can still deliver the fluid provided via the loop inlet tube 108B to the first collection flow chamber 544 of the blood component collection bladder 536, and the fluid can also be delivered from the first collection flow chamber 544 of the blood component collection bladder 536 to the flexible loop 524. Additionally or alternatively, when the components are in the bent state, the flexible loop 524 can deliver the fluid from the second collection flow chamber 552 of the blood component collection bladder 536 to the loop outlet tube 112, and the fluid can also be delivered from the loop outlet tube 112 to the second collection flow chamber 552 of the blood component collection bladder 536.

[0181] In some embodiments, the blood component collection loop 520 may be pre-formed to fit within the collection insertion channel 466 of the filler 460, as shown in Figure 5Fas shown in the perspective view. Such preforming may include twisting the blood component collection bladder 536 of the blood component collection loop 520 to match the generally helical path 490 of the collection insertion channel 466. Once the preforming is complete, features of the blood component collection loop 520 may be aligned with one or more features of the filler 460, as Figure 5G shown. In one embodiment, the filler loop connector 532 of the blood component collection loop 520 may be aligned with the loop connection region 454 of the filler 460 such that the second connection positioning feature 530B is aligned to engage the first rigid positioning feature 478. Additionally or alternatively, the blood component collection bladder 536 may be shaped or formed (e.g., by hand, etc.) to match the generally helical path 490 of the collection insertion channel 466 in the filler 460. In some cases, such shaping or forming may include aligning the bladder free end 540B of the blood component collection bladder 536 with the channel end 472 of the collection insertion channel 466 in the filler 460. When the components are generally aligned with each other, the blood component collection loop 520 may be moved in the direction of the collection insertion channel 466 and the loop connection region 454 (as Figure 5G shown).

[0182] In some embodiments, when the filler loop connector 532 moves towards and into the loop connection region 454 of the filler 460, the first rigid positioning feature 478 may interconnect and / or hold the second connection position feature 530B of the filler loop connector 532 of the blood component collection loop 520. Such interconnection may prevent the filler loop connector 532 from rotating relative to the filler 460. In some cases, this interconnection may hold the filler loop connector 532 of the blood component collection loop 520 within the loop connection region 454 of the filler 460. Figure 5H A perspective view of the blood component collection loop 520 loaded in the filler 460 according to an embodiment of the present disclosure is shown.

[0183] Figures 6A to 6C A schematic cross-sectional view of the centrifuge assembly 400 in different loop loading states according to an embodiment of the present disclosure is shown. Figures 6A to 6C The centrifuge assembly 400 shown may correspond to the centrifuge assembly 400 described above, and in particular in combination with Figures 4D to 4F . In particular, Figure 6A a schematic cross-sectional view of a first loop loading state is shown, Figure 6B a schematic cross-sectional view of a second loop loading state is shown, Figure 6C a schematic cross-sectional view of a second loop loading state of the centrifuge assembly 400 is shown.

[0184] In Figure 6AIn [description], the centrifuge assembly 400 is shown in an open loop loading position, where the upper housing 404B has been pivoted 180 degrees from the closed or operating position. This open position may correspond to Figure 4F the position of the centrifuge assembly 400 shown. However, in Figure 6A [description], the blood component collection loop 520 has been inserted into the filler 460, and the filler loop connector 532 is interconnected with the loop connection area 454 of the filler body 464. The other end of the blood component collection loop 520 is connected to the fixed loop connector 402 through the system static loop connector 528. In this first loop loading state, the flexible loop 524 is fixed at the fixed loop connector 402 so as not to rotate, but rotates with the filler 460 at the loop connection area 454.

[0185] In Figure 6B [description], the centrifuge assembly 400 is shown in a partially closed position, where the upper housing 404B is moving from the open position to the closed or operating position. As the upper housing 404B pivots, the flexible loop 524 can move to a stationary position relative to the centrifuge assembly 400. Although the flexible loop 524 is rotatably fixed to the fixed loop connector 402, the filler 460 can rotate freely about the filler rotation axis 430B (e.g., only restricted by the rotatably fixed flexible loop 524).

[0186] In Figure 6CIn [the figure], the centrifuge assembly 400 is shown in a closed or operating position where the upper housing 404B can be locked to the lower housing 404A (such that the lower housing 404A and the upper housing 404B can rotate together about the centrifuge rotation axis 430). In this position, the flexible ring 524 can pass from the ring connection area 454 of the filler 460 through the ring of the centrifuge split housing 404 into the gap 436 to reach the fixed ring connector 402. In some embodiments, the flexible ring 524 can move freely within the ring entry gap 436, contacting or not contacting one or more portions of the centrifuge split housing 404. In this position, when the centrifuge assembly 400 rotates about the centrifuge rotation axis 430, the flexible ring 524 rotatably fixed to the fixed ring connector 402 can twist along the length of the flexible ring 524, thereby rotating the filler 460 inside the centrifuge assembly 400 (e.g., along the centrifuge rotation axis 430). As described above, the rotation of the filler 460 relative to the centrifuge assembly 400 can be at a ratio of 2:1. For example, when the centrifuge assembly 400 rotates one full turn, the rotatably fixed flexible ring 524 (e.g., fixed at the fixed ring connector 402) twists at the ring connection area 454 (e.g., attempts to break away from the twist caused by the rotation of the centrifuge assembly 400, etc.), thereby rotating the filler 460 in the same rotational direction as the centrifuge assembly 400, but rotating substantially two full turns. This rotation of the filler 460 by the twisting of the flexible ring 524 along its length does not require a transmission between the centrifuge assembly 400 and the filler 460.

[0187] Figures 7A to 7B A schematic plan view of a centrifuge assembly 400 is shown, which automatically loads a ring into an operating position for centrifugation (e.g., blood separation). As Figures 7A to 7B shown, the centrifuge assembly 400 can correspond to the centrifuge assembly 400 discussed previously and / or incorporated Figures 4A to 4F and Figures 6A to 6C described. Once the blood component collection ring 520 has been loaded into the centrifuge assembly 400, as Figure 6C shown, the flexible ring 524 can be automatically loaded into the ring engagement position 520B, as Figures 7A to 7B shown.

[0188] In one embodiment, when the upper housing 404B is locked to the lower housing 404A, the flexible ring 524 can extend from the ring connection region 454 of the filler 460 to the fixed ring connector 402 of the apheresis system 200. Although the flexible ring 524 can be rotationally fixed to the fixed ring connector 402 at the system static ring connector 528, the flexible ring 524 passing through the ring into the gap 436 in the centrifuge split housing 404 may not initially be held or at least partially captured by the ring rotation position guide 424 and / or other features of the centrifuge assembly 400. This state of the flexible ring 524 relative to the ring rotation position guide 424 or the ring arm can correspond to the ring uncaptured state 700A. In other words, the flexible ring 524 can be oriented at an angle α relative to the ring rotation position guide 424, the ring position stop plate 704, and / or one or more ring torsion support bearings 708 or bearing sets. In some embodiments, the ring torsion support bearings 708 can correspond to the bearings 417 described in conjunction with Figures 4B to 4C The ring receiving area or channel can be formed by the ring position stop plate 704 and / or one or more ring torsion support bearings 708 disposed along the length of the upper housing 404. In some embodiments, this orientation can be designed to allow entry and / or easy loading during ring loading described in conjunction with Figures 6A to 6C When the centrifuge assembly 400 rotates about the centrifuge rotation axis 430 in the ring and filler rotation direction 712, the flexible ring 524 can move from

[0189] the ring uncaptured state 700A shown to the ring captured state 700B. This rotation can be caused by the operator rotating the centrifuge assembly 400 and / or the filler 460 in the ring and filler rotation direction 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, when the flexible ring 524 rotates in the ring and filler rotation direction 712, the outer portion of the flexible ring 524 can contact the ring position stop plate 704 or other rotation stop surface of the ring rotation position guide 424. Figure 7B When the centrifuge assembly 400 rotates about the centrifuge rotation axis 430 in the ring and filler rotation direction 712, the flexible ring 524 can move from the ring uncaptured state 700A shown to the ring captured state 700B. This rotation can be caused by the operator rotating the centrifuge assembly 400 and / or the filler 460 in the ring and filler rotation direction 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, when the flexible ring 524 rotates in the ring and filler rotation direction 712, the outer portion of the flexible ring 524 can contact the ring position stop plate 704 or other rotation stop surface of the ring rotation position guide 424.

[0190] When the flexible ring 524 is held or at least partially contained within the ring rotation position guide 424, a portion of the flexible ring 524 may move within one or more of the ring torsion support bearings 708. As described above, the flexible ring 524 may be rotationally fixed to the stationary ring connector 402 by the first connection position feature 530A of the system stationary ring connector 528 associated with the blood component collection ring 520. This rotationally fixed connection prevents the flexible ring 524 from rotating relative to the apheresis system 200 at the stationary ring connector 402. The other end of the flexible ring 524 may be interconnected at the ring connection region 454 of the filler 460, where this end may move with the filler 460 and / or the centrifuge assembly 400. When the centrifuge assembly 400 continues to rotate in the ring and filler rotation direction 712, the force from the flexible ring 524 attempts to untangle or prevent the binding of the filler 460 and the end of the flexible ring 524 attached thereto, the filler 460 and the end of the flexible ring 524 attached thereto, the rotating filler 460 and the end of the flexible ring 524 attached thereto.

[0191] In any case, once the fluid separation method described herein is completed, the centrifuge assembly 400 may be stopped and the centrifuge split housing 404 may be opened to remove the disposable elements of the blood component collection device 500 from the centrifuge assembly 400. In some cases, by rotating the centrifuge assembly 400 and / or the filler 460 in a direction opposite to the ring and filler rotation direction 712, the flexible ring 524 may move from Figure 7B the ring captured state 700B shown to Figure 7A the ring uncaptured state 700A shown.

[0192] According to an embodiment of the present disclosure, a functional diagram of the apheresis system 200 may be as shown in Figure 8 This description shows in the functional diagram the components previously described in Figures 1 to 7B to describe the operation of the system 200, which is used to extract plasma or other blood components from the whole blood of the blood donor 102 during an apheresis procedure or process.

[0193] System 200 may include an anticoagulant (AC) pump 216. The AC pump 216 pumps fluid from the AC bag 114 in the AC tube 110. The AC pump 216, the AC tube 110, and / or the AC bag 114 may be as described previously. The AC tube 110 may further include an AC air detection sensor (ADS) 804 to detect air or fluid within the AC tube 110. The AC ADS 804 may be the same as or similar to the sensors 284 and / or sensor 312 described previously in type and / or function. The AC tube 110 may intersect and be in fluid communication with the donor blood supply tube 104 and the cassette inlet tube 108A at the tube connector 106. The tube connector 106 may be any type of connector as described previously located between the tubes 110, 104, and / or 108A.

[0194] The donor blood supply tube 104 starts from the donor 102, and the donor 102 may be punctured by 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 may extend to the soft cassette 340. Additionally, a donor air detection sensor 312 may be placed on or within the tube 108A to detect the presence of fluid and / or air within the tube 108A.

[0195] As described previously, the soft cassette 340 may include a first cassette port 360A, and the first cassette port 360A may serve as, include, and / or be substantially proximate to a "Y" connector or section or branch that divides the tube 108A into a first bypass branch 358A and a first tube section 368A (the "Y" portion will be denoted by the reference symbol 360A). The two tube sections 358 and 368 may be reconnected at a second cassette port 360B, and the second cassette port 360B may also serve as, include, and / or be substantially proximate to a second "Y" connector or section (the second "Y" portion will be denoted by the reference symbol 360B). The tube 358 is divided into two by the fluid sensor 316, and the fluid sensor 316 divides the tube 358 into a first bypass branch 358A and a second bypass branch 358B. Similarly, the tube 368 is divided into two by the drip chamber 354, and the drip chamber 354 divides the 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. Similarly, the first bypass branch 358A may include a suction fluid control valve 320C. Thus, based on the configuration of the system 200 and depending on the operation of the system 200, the respective tube sections of the tubes 368A, 358A, 358B, and 368B may be separated by the valves 320A, 320B, and / or 320C.

[0197] The drip chamber 354 can be disposed between the first tube segment 368A and the second tube segment 368B. The drip chamber 354 can collect a certain volume of whole blood and / or hyperhematocrit blood (blood with a high percentage of red blood cells) according to the operation of the system 200, as described below. The fluid sensor 316 can be disposed between the first bypass branch 358A and the second bypass branch 358B as previously described.

[0198] The loop inlet tube 108B can be connected to the second cassette port 360B and can connect the flexible cassette 340 to the flexible loop 524. The loop inlet tube 108B can also include a sensor 808 disposed on or in the tube 108B and placed with the tube 108B before connecting to the system static loop connector 528 of the flexible loop 524. The pressure sensor (CPS) 808 can detect one or more of the following, but is not limited to the following: pressure, the presence and / or absence of fluid or air, and / or another possible characteristic of the fluid in the tube 108B. Additionally, the aspiration pump 208 can cause fluid to flow through the tube 108B to be pumped away from the flexible cassette 340 or to the flexible cassette 340.

[0199] Two or more different tubes can be connected to the flexible loop 524 through the system static loop connector 528 and provide fluid to or receive fluid from the blood component collection bladder 536. The loop outlet tube 112 exits the system static loop connector 528 from the flexible loop 524. The loop outlet tube 112 can also include another line sensor 812 disposed on or in it to detect fluid, air, cell concentration, color, and / or color change in the fluid from the flexible loop 524; the line sensor 812 can be the same or similar in type and / or function to the previously described sensors 804, 312, 320, 808, and / or 284. A second CPS sensor 816 or fluid sensor can also be disposed in or on the line 112. The sensor 816 can detect one or more of the following, but is not limited to the following: the presence or absence of fluid, the pressure within the tube 112, and / or other characteristics of the fluid within the tube 112. Similarly, the sensor 816 can be the same or similar in type and / or function to the previously described sensors 804, 312, 320, 808, 812, and / or 284.

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

[0201] The saline bag 118 and associated tubing can be as described previously, and saline can be provided back to the donor 102 via the system 200. A saline flow control valve 288 can separate the saline bag 118 from the remainder of the system 200. Additionally, the plasma collection bottle 122 can receive plasma from the flexible loop 524 when processing whole blood or separating from whole blood. The plasma collection bottle 122 can be selectively separated from the system via a plasma flow control valve 286.

[0202] According to embodiments of the present disclosure, embodiments of the electronic and control system 900 that controls the functions of the apheresis system 200 can be as Figure 9 shown. The control system 900 can include one or more nodes, and the one or more nodes can include various hardware, firmware, and / or software that are configured to control and / or communicate with the mechanical, electromechanical, and electronic components of the apheresis system 200.

[0203] Each node can be used to control different parts of the apheresis system 200. For example, the control system 900 can include a cassette node 904 and a centrifuge node 908, which can respectively control or communicate with the components of the blood component collection device 500 (and associated hardware or mechanical components that interact with the soft cassette assembly 300) and the centrifuge assembly 400 (and associated associated hardware or mechanical components). The cassette node 904 and the centrifuge node 908 can communicate wirelessly or via some other electronic or data connection. In some configurations, the separate nodes 904, 908 can be two parts of a single node 902. Thus, each node 904, 908 can have the same physical hardware to control different functions. An example of the cassette node 904 can be as described in connection with Figure 10 as described; the centrifuge node 908 can be as described in connection with Figure 11 as described.

[0204] Each of the nodes 904, 908 can communicate with one or more of the sensors 916, 920, and / or 924. There can be more than Figure 9More or fewer sensors as shown, such as indicated by ellipsis 928. Each node 904, 908 can communicate directly with each sensor 916 - 924, or can communicate with multiple sensors 916 - 924 via bus 912. Bus 912 can communicate via any type of communication protocol, such as Universal Serial Bus (USB), Universal Asynchronous Receiver / Transmitter (UART), or other types of bus systems or parallel communication connections. Thus, bus 912 can be optional, but is shown as a possible communication platform for communicating with various sensors 916 - 924. Sensors 916 - 924 can be any type of sensor as described herein that is capable of transmitting information about the presence of light, fluid, air, color, pressure, etc. Some sensors 916 - 924 can include sensors 312, 316, 804, 808, 812, 816, and / or 284. The functions of these sensors 912 - 924 can be as described below.

[0205] Nodes 904, 908 can also communicate with one or more of a pump driver, pump motors 936, 940, 944 (referred to simply as "pumps"), etc. There can be more or fewer pumps than Figure 9 shown, such as indicated by ellipsis 948. Nodes 904, 908 can communicate with pumps 936 - 944 via direct wired or wireless communication or via bus 932. Bus 932 can be a Controller Area Network (CAN) bus, USB, or other type of bus architecture for communicating with pumps 936 - 944. As previously mentioned, pumps 936 - 944 can include pumps 216, 208, and / or 212. The functions of pumps 936 - 944 can be as described herein.

[0206] According to an embodiment of the present disclosure, an embodiment of the cartridge node 904 can be as Figure 10 shown. The cartridge node 904 can include a controller 1004, a memory 1008, a valve controller 1020, and / or one or more communication interfaces for a CAN bus 1016, UART 1012, or other type of bus. The cartridge node 904 can include other hardware, firmware, and / or software that are not shown for clarity.

[0207] The controller 1004 can be any type of microcontroller, microprocessor, Field Programmable Gate Array (FPGA), Application Specific Integrated Circuit (ASIC), etc. An example controller 1004 can be the NK10DN512VOK10 microcontroller manufactured and sold by N9P USA, which is a microcontroller unit with a 32-bit architecture. Other types of controllers are also possible. The controller 1004 can control other types of devices or direct the functions of other types of devices (such as valves 320A, 320B, 320C, 286, 288, pumps 936 - 944, etc.). Additionally, the controller 1004 can communicate with various sensors 916 - 924 or other devices to receive or send information regarding the functions of the apheresis system 200.

[0208] Other examples of the processor or microcontroller 1004 as described herein can include, but are not limited to 800 and 801, 610 and 615 (with 4G LTE integration and 64-bit operation), A7 processor (with 64-bit architecture), M7 motion coprocessor, series, Core TM ( Core TM ) family of processors, family of processors, ( Atom TM ) family of processors, family of processors, i5 - 4670K and i7 - 4770K 22-nanometer Haswell, i5 - 3570K 22-nanometer Ivy Bridge, FX TM family of processors, FX - 4300, FX - 6300 and FX - 8350 32-nanometer Vishera, Kaveri processor, Corte TM -M processor, Cortex-A and ARM926EJ-S TMProcessors and other industry-equivalent processors, and can perform computing functions using any known or future-developed standards, instruction sets, libraries, and architectures.

[0209] Memory 1008 can be any type of memory, including random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), portable compact disc read-only memory (CD-ROM), optical storage devices, magnetic storage devices, any suitable combination of the foregoing, or other types of storage or storage devices that store and provide instructions for programming and controlling controller 1004. As described below, memory 1008 can provide all types of software or firmware for programming the functions of controller 1004.

[0210] Controller 1004 can communicate with one or more valve controllers 1020. Each valve 320A, 320B, 320C, 286, 288 as described herein can be controlled by valve controller 1020 and can be associated with components of system 200 as described herein. Valve controller 1020 can provide an electrical signal, operation instruction, or power supply to close or open any one of the valves described herein, such as the saline and plasma valve housing 276, plasma flow control valve 286, saline flow control valve 288, first fluid control valve 320A, first fluid control valve 320A, and / or suction fluid control valve 320C, etc.

[0211] Controller 1004 can also be connected to buses 912, 932 (e.g., UART bus, CAN bus) or other buses through transceivers 1012, 1016 disposed outside controller 1004 or integrated into controller 1004. UART 1012 can communicate with one or more of sensors 916 - 924 or other devices. Similarly, CAN bus transceiver 1016 can communicate with one or more of pump controllers 936 - 944 or other devices. UART transceiver 1012 and the bus, as well as CAN bus transceiver 1016 and the bus, are well known in the art and do not require further explanation herein.

[0212] According to an embodiment of the present disclosure, an embodiment of centrifuge node 908 can be as Figure 11 shown. Centrifuge node 908 can include components of the same or similar type as box node 904. For example, centrifuge node 908 can include controller 1104, UART transceiver 1112, etc. Similar to controller 1004, controller 1104 can be any type of processor or microcontroller, e.g., the NK10DN512VOK10 microcontroller unit with a 32-bit architecture from N9P USA (USA) company as described above, or other controllers, processors, etc., such as the devices mentioned above.

[0213] The controller 1104 can communicate directly, via the UART transceiver 1112, or via other buses or systems with the sensors 916 - 924. The controller 1104 can also communicate with a brake controller 1124, which can brake or slow down and stop the centrifuge 400. Similarly, the controller 1104 can communicate with a motor transceiver 1116, which communicates with a motor power system or a motor controller that is used to rotate or turn the centrifuge 400 or control the speed configuration or other functions of the centrifuge 400.

[0214] In some configurations, the controller 1104 can also communicate with a cuff controller 1122, which can change or set the pressure of a pressure cuff on the donor's arm during the apheresis process. Additionally, the controller 1104 can communicate with and / or control a flash lamp 1112, which can be any lamp that flashes in a cycle synchronized with the motor speed, such that an operator of the apheresis system 200 can see the operation of the filler 460 as described above. Thus, the controller 1104 can communicate with the flash lamp 1112 to change the flash frequency of the flash lamp 1112, the intensity of the flash lamp 1112, etc.

[0215] According to an embodiment of the present disclosure, an embodiment of a method 1200 for performing apheresis of a blood component (e.g., plasma) using the system 200 can be as Figure 12 shown. The method 1200 can be described in conjunction Figures 17A to 17T with. Thus, the method 1200 will be described in conjunction with or with reference to these drawings. The general order of the steps of the method 1200 is as Figure 12 shown. Generally, the method 1200 begins with a start operation 1204 and ends with an operation 1220. The method 1200 can include more or fewer steps, or the steps can be arranged in an order different from Figure 12 shown. The method 1200 can be executed at least in part by a set of computer - executable instructions executed by a computer system, a processor, a cartridge microcontroller 1004, a centrifuge microcontroller 1104, and / or another device, and is encoded or stored on a computer - readable medium. In other configurations, the method 1200 can be executed at least in part by a series of components, circuits, gates, etc. created in a hardware device such as a System on Chip (SOC), an ASIC, and / or an FPGA. Hereinafter, the method 1200 will be explained with reference to the systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signaling processes, models, environments, apheresis systems, etc. described in Figures 1 to 11

[0216] ​Method 1200 can generally be divided into three phases, each of which includes a series of steps or processes. Each of the three phases is described in Figure 12 and refers to Figures 13 to 16 that describes the steps or processes. Method 1200 can include a system preparation phase at step 1208. In this phase 1208, the operator can prepare the apheresis system 200, and this phase can include steps such as placing the needle in the donor 102, performing other operations to prepare for blood drawing, inserting the blood component collection device 500 into the system, etc. Examples of steps that can be included in the system preparation phase 1208 can be as described in conjunction with Figure 13 .

[0217] Then, method 1200 can enter the plasma extraction phase at step 1212. The plasma extraction phase 1212 can be as described in conjunction with Figure 14 . The plasma extraction phase 1212 can include drawing blood, extracting plasma (and / or other blood components) by centrifuging the blood, returning the high hematocrit blood (such as red blood cells) and / or other blood components to the donor 102 in various return cycles (until the entire sample of plasma and / or other blood components is collected), etc. The start of the return cycle can be triggered based on the presence of one or more blood components, such as platelets, red blood cells, etc., at a certain predetermined location in the apheresis system.

[0218] In step 1216, the last phase of method 1200 can be the disposable supplies unloading phase. The disposable supplies unloading phase 1216 can be described in conjunction with Figure 15 . The disposable supplies unloading phase 1216 can include completing the apheresis process, removing the needle from the donor 102, unloading the blood component collection device 500, and completing the process. Now each of the three phases 1208 - 1216, as well as the associated steps or processes, will be described below.

[0219] According to an embodiment of the present disclosure, the method for preparing the apheresis system 200 described in phase 1208 can be as shown in Figure 13 . The general order of the steps of method 1300 is as shown in Figure 13 . Generally, method 1300 starts with the start operation 1304 and ends with the operation 1328. Method 1300 can include more or fewer steps, or can be different from Figure 13The sequential arrangement steps shown. Method 1300 can be executed at least in part as a set of computer-executable instructions executed by a computer system, a processor, the cassette microcontroller 1004, the centrifuge microcontroller 1104, and / or other devices, and is encoded or stored on a computer-readable medium. In other configurations, method 1300 can be executed at least in part by a series of components, circuits, gates, etc. created in hardware devices such as SOC, ASIC, and / or FPGA. Hereinafter, method 1300 will be explained with reference to the Figures 1 to 12 systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signaling processes, models, environments, apheresis systems, methods, etc. described

[0220] In step 1308, a user or operator can load the blood component collection device 500. In this step 1308, the user can load the blood component collection device 500 into the system 200, including inserting the flexible ring 524 into the ring receiving bracket 426 and inserting the blood component collection bladder 536 into the filler 460 (both of which can be as Figure 16 described). Additionally, the soft cassette 340 can be installed in the soft cassette assembly 300, as described in conjunction with Figure 1 、 Figure 2A 、 Figure 2B 、 Figure 3A and / or Figure 3B described. The ring inlet tube 108B can be inserted into the guide tube guide 244 and / or the end tube guide 252, up to the suction pump 208, to enable fluid movement in the ring inlet tube 108B and other parts of the blood component collection device 500. Similarly, the anticoagulant tube 110 can be placed in a tube guide (similar to guides 244, 252) to allow the AC pump 216 to move the anticoagulant into the anticoagulant tube 110 or other parts of the blood component collection device 500. The ring outlet tube 112 can be inserted into similar guides 244, 252 to allow the return pump 212 to move blood components (such as plasma) into the plasma collection bottle 122, or to move saline from the saline bag 118 into the ring outlet tube 112 or other parts of the blood component collection device 500.

[0221] As Figure 2D shown, the saline and plasma tube y-connector 280 can be installed in the plasma and saline valve control system 228 to allow the valves 286, 288 to control the fluid flow from and / or to the plasma collection bottle 122 and / or the saline bag 118. The AC bag 114 can be installed on the anticoagulant bracket 232A, the plasma collection bottle 122 can be placed in the plasma collection bracket 232C, and the saline bag 118 can be installed on the saline bracket 232B, as Figures 1 to 2BAs described above. Since the blood component collection device 500 is installed in the apheresis system 200, the apheresis system 200 can be presented as shown in Figure 17A and Figure 17B . During this step, the states of the components of the apheresis system 200 can be as follows:

[0222]

[0223] Table 1: Loading Kit Status

[0224] As shown in the above table and the subsequent tables, the suction pump 208 and the return pump 212 can block the loop inlet tube 108B and the anticoagulant tube 110 respectively. In this way, the suction pump 208 and the return pump 212 act as "valves" that selectively allow or prohibit fluid flow. The minus sign "-" in the "Flow Rate" column indicates that the pump is rotating in the counterclockwise direction. The abbreviation "AF" represents "Automatic Flow", indicating that the pump operates at the flow rate of the blood from the blood donor 102. This AF flow prevents the apheresis system 200 from sucking blood from the blood donor 102 or causing blood to flow back to the blood donor 102, and / or the AF optimizes the extraction and reflux flow rates while enhancing the safety of the blood donor.

[0225] In step 1312, the saline bag 118 can be punctured. The user can remove any safety cover from the bag needle fitting 512 at the distal end of the saline tube 116 to pierce the saline bag 118 containing saline. In other configurations, the saline tube 116 can be mechanically attached to the saline bag 118 (e.g., via a Luer connector), and a frangible device or other removable barrier can be changed by the user to allow the saline from the saline bag 118 to flow. Thus, puncturing the saline bag 118 allows the saline to flow into the blood component collection device 500, reaching or flowing through the saline flow control valve 288. During this step, the states of the components of the apheresis system 200 can be as follows:

[0226]

[0227] Table 2: Puncturing Saline Status

[0228] In step 1316, the saline 1712 is injected. Injecting the saline 1712 includes the cartridge microcontroller 1004 controlling the opening of the saline flow control valve 288, as shown in Figure 17DAs shown. The cassette microcontroller 1004 can receive instructions for a user interface or a program to initiate a apheresis process that begins with the infusion of normal saline 1712. Thus, normal saline 1712 flows from the normal saline bag 118 through the normal saline flow control valve 288 to the plasma air detection sensor 284. The cassette microcontroller 1004 controls the return pump 212 to rotate counterclockwise so that a volume of normal saline 1712 from the normal saline bag 118 flows through the normal saline tube 116 and the normal saline and plasma tube y-connector 280 installed in the plasma and normal saline valve control system 228 to the plasma air detection sensor 284. When the plasma air detection sensor 284 detects the presence of liquid or the absence of air in the loop outlet tube 112, a signal is sent to the cassette microcontroller 1004. Then, the cassette microcontroller 1004 can instruct the return pump 212 to stop rotating and instruct the normal saline flow control valve 288 to close, which prevents normal saline 1712 from further entering the loop outlet tube 112 that is substantially farther than the plasma air detection sensor 284. At this point in the process, the apheresis system can be as Figure 17E shown. During this step, the status of the components of the apheresis system 200 can be as follows:

[0229]

[0230] Table 3: Status of Infusing Normal Saline

[0231] It should be noted that the return pump 212 is described as rotating counterclockwise. This direction of rotation is associated with the position of the return pump 212 relative to the loop outlet tube 112. If the return pump 212 is installed such that the loop outlet tube 112 is located below the return pump 212, the return pump 212 will rotate clockwise to cause normal saline 1712 from the normal saline bag 118 to flow. Thus, throughout the specification, the direction of rotation of the pumps will be described for the return pump 212, the aspiration pump 208, and / or the AC pump 216, but these directions of rotation can be different if the pumps 208, 212, 216 are installed or placed differently. Additionally, other types of pumps can be used, which will change how the pumps operate to cause various liquids or air to flow in the system 200. Those skilled in the art will understand how to make these modifications to achieve similar results as described in the following processes and steps.

[0232] In addition, the amounts and flow rates of the flows in the apheresis system 200 are mentioned or described in the tables included herein. However, these amounts and rates depend on the size of the tubing, the size of the bags used, the desired amount of the blood components being collected (e.g., 880 mL of plasma), and other factors considered. State or national laws and other regulations may control the amounts and rates used in the apheresis system 200, or those amounts and rates of the flows, and may preset the amounts and flow rates of the flows based on the guidance of medical professionals or based on the characteristics of the donor 102. Thus, the flow rates and flow speeds are merely exemplary, but those skilled in the art will know what amounts and flow rates of the flows are set for the following steps and processes.

[0233] Thereafter, in step 1320, the anticoagulant 1702 may be spiked. Adding the anticoagulant 1702 may be similar to the process of adding the normal saline 1712. For example, the tubing fitting 508 may be attached by the user to the AC bag 114. Then, the user may break a frangible member, open a valve or other device, or modify some structure that allows the AC 1702 to flow into the anticoagulant tubing 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 be as Figure 17E shown. The cassette microcontroller 1004 may signal by the user via a user interface or other user input device that the AC bag 114 has been connected or punctured. During this step, the status of the components of the apheresis system 200 may be as follows:

[0234]

[0235] Table 4: Status of spiking anticoagulant

[0236] Then, in step 1324, in response to a signal from the user, the cassette microcontroller 1004 may activate the AC 1702. To inject the AC 1702, the cassette microcontroller 1004 may direct the AC pump 216 to operate or rotate in a clockwise direction to pump the anticoagulant 1702 from the AC bag 114 into the anticoagulant tubing 110, as Figure 17F and Figure 17GAs shown, the donor supply line 104 can be blocked by a clamp, frangible device, or other structure. Thus, AC 1702 does not flow from the donor supply line 104 to the donor 102. Instead, the AC pump 216 can push the anticoagulant 1702 into the cassette inlet tube 108A, into the soft cassette 340, and partially into the loop inlet tube 108B. In an embodiment, the AC 1702 flows through the first bypass branch 358A, the second bypass branch 358B, and / or the fluid sensor 316, but does not necessarily flow into the first tube section 368A or the second tube section 368B. Thus, the cassette microcontroller 1004 can close the first fluid control valve 320A to prevent the AC 1702 from flowing into the first tube section 368A, the drip chamber 354, or the second tube section 368B. Pre-positioning the AC 1702 in the first bypass branch 358A, the second bypass branch 358B, and / or the fluid sensor 316 ensures the correct flow of whole blood during the first draw of whole blood from the donor 102 and prevents a large amount of the AC 1702 from returning from the drip chamber 354 to the donor 102 when the red blood cells return after the process.

[0237] To determine when to stop the AC pump 216, the cassette microcontroller 1004 can receive a signal from the fluid sensor 316 and / or the donor air detection sensor 312 indicating that fluid is at or passing through the sensors 312, 316. When the fluid sensor 316 provides an indication to the cassette microcontroller 1004 that the AC 1702 has reached the sensor 316, the cassette microcontroller 1004 can continue to direct the AC pump 216 for a predetermined period of time until a known amount of the AC 1702 has been pumped through the second cassette port 360B and partially into the loop inlet tube 108B. Thus, the injection of the AC 1702 places the apheresis system 200 in the state as Figure 17G shown. During this step, the status of the components of the apheresis system 200 can be as follows:

[0238]

[0239]

[0240] Table 5: Anticoagulant Injection Status

[0241] In some configurations, the direction of the AC pump 216 can be reversed, as Figure 17GAs shown. Then at least a portion of the anticoagulant 1702 can be pumped back into the AC bag 114 and / or a portion of the cassette inlet tube 108A and / or the anticoagulant tube 110. In an embodiment, the cassette microcontroller 1004 can instruct the aspiration fluid control valve 320C to close to retain the AC in the first bypass branch 358A, the second bypass branch 358B, and / or the fluid sensor 316. The donor air detection sensor 312 can determine when the AC 1702 stops passing through the sensor 312 and send a signal to the cassette microcontroller 1004. Similarly, the cassette microcontroller 1004 can continue to direct the AC pump 216 for a predetermined time until a known amount of the AC 1702 is pumped back through the cassette inlet tube 108A. Thus, the AC 1702 places the apheresis system 200 in the state as shown in Figure 17H As shown. The amount of anticoagulant remaining in the cassette inlet tube 108A, the tube connector 106, and / or the anticoagulant tube 110 can be determined by the cassette microcontroller 1004 based on the amount of time after the anticoagulant 1702 has flowed through the donor air detection sensor 312. This process leaves some anticoagulant in the cassette inlet tube 108A but reduces the amount of AC, which prevents the problem of excessive AC mixing with the incoming whole blood. At this point, in stage 1212 ( Figure 12 ), the apheresis system 200 is ready and prepared to draw whole blood. During this step, the states of the different components of the apheresis system 200 can be as shown below:

[0242]

[0243]

[0244] Table 6: Status of AC injection completion

[0245] According to an embodiment of the present disclosure, an embodiment of the method 1400 representing the plasma extraction stage 1212 can be as shown in Figure 14 As shown. The general order of the steps of the method 1400 is as shown in Figure 14 As shown. Generally, the method 1400 begins with the start operation 1404 and ends with the operation 1440. The method 1400 can include more or fewer steps, or the steps can be arranged in an order different from that shown in Figure 14 As shown. The method 1400 can be executed at least in part by a set of computer-executable instructions executed by a computer system, a processor, the cassette microcontroller 1004, the centrifuge microcontroller 1104, and / or other devices, and is encoded or stored on a computer-readable medium. In other configurations, the method 1400 can be executed at least in part by a series of components, circuits, gates, etc. created in a hardware device such as an SOC, an ASIC, and / or an FPGA. Hereinafter, in combination with Figures 1 to 13The described systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signaling processes, models, environments, apheresis systems, methods, etc. explain Method 1400.

[0246] In step 1408, a needle can be inserted into the blood donor 102. A phlebotomist, apheresis technician, or other medical professional can connect a needle with a lumen to the tubing fitting 504 and insert the needle into a blood vessel (e.g., vein) of the blood donor 102. Thus, the apheresis system 200 can be fluidly connected to the blood donor 102 and is ready to draw whole blood. Accordingly, the apheresis system 200 begins the plasma extraction phase 1212 in a state where the blood donor 102 is ready to provide whole blood, as Figure 17H shown. During this step, the states of the components of the apheresis system 200 can be as follows:

[0247]

[0248]

[0249] Table 7: State of Inserting Needle into Blood Donor

[0250] In step 1412, the cassette microcontroller 1004 of the apheresis system 200 can start drawing whole blood 1706. The cassette microcontroller 1004 can direct the operation of the AC pump 216, the suction pump 208, and / or the return pump 212 by rotating in a clockwise direction. The AC pump 216 pushes the anticoagulant 1702 towards the plasma collection bottle 122, such that the AC pump 1702 mixes with the whole blood 1706 drawn from the blood donor 102 in the tubing connector 106 (and possibly in the blood donor supply tube 104) and other parts away from the tubing connector 106. The suction pump 208 and / or the return pump 212 suck the whole blood 1706 (and AC) from the blood donor 102 into the soft cassette 340, the flexible loop 524, and / or the blood component collection bladder 536. During this process 1412, the cassette microcontroller 1004 and the centrifuge microcontroller 1008 can communicate to notify the centrifuge microcontroller 1008 that the suction has started. In response to the indication that the suction has started, the centrifuge microcontroller 1008 can instruct the rotor and motor assembly 414 of the centrifuge assembly 400 to start rotating or turning. The initial rotation rate can be slow to allow the blood component collection bladder 536 to be positioned in the filler insertion chamber 492 and suck the whole blood 1706 into the blood component collection bladder 536. During this step 1412, the state of the apheresis system 200 can be as Figure 17I shown. During this step, the states of the components of the apheresis system 200 can be as follows:

[0251]

[0252]

[0253] Table 8: Starting Extraction Status

[0254] In step 1416, the region of the blood component collection bladder 536 adjacent to the channel inlet 468, the channel end 472, and / or the channel path protrusion 476 is injected with whole blood 1706. The cassette microcontroller 1004 stops the operation of the return pump 212, but the AC pump 216 and the aspiration pump 208 continue to operate. The whole blood 1706 is pushed through the first tube section 368A, the drip chamber 354, and / or the second tube section 368B. The whole blood 1706 is pushed from the soft cassette 340 through the flexible loop 524 and into the blood component collection bladder 536, reaching the bladder free end 540B. The anticoagulant pump 216 continues to operate to mix the anticoagulant 1702 from the anticoagulant bag 114 with the whole blood 1706 drawn from the blood donor 102. During step 1416, the apheresis system 200 can be as Figure 17J shown. During this step, the status of the components of the apheresis system 200 can be as follows:

[0255]

[0256] Table 9: Injection Channel Status

[0257] Further communication occurs between the cassette microcontroller 1004 and the centrifuge microcontroller 1008 to indicate the injection of the channel. In response to these communications, the centrifuge microcontroller 1008 instructs the rotor and motor assembly 414 of the centrifuge assembly 400 to start rotating or turning at a higher revolutions per minute (RPM).

[0258] Now referring to step 1420, the cassette microcontroller 1004 begins to perform the first extraction of plasma 1704 or other blood components from the whole blood 1706. The cassette microcontroller 1004 causes the AC pump 216 to continue operating to supply the anticoagulant 1702 into the cassette inlet tube 108A to mix with the whole blood 1706 from the blood donor 102. In addition, the cassette microcontroller 1004 causes the aspiration pump 208 to continue operating to cause the whole blood 1706 to flow into the blood component collection bladder 536 to separate the plasma 1704 from the whole blood 1706. To achieve the separation of the plasma 1704, the cassette microcontroller 1004 notifies the centrifuge microcontroller 1008 that the aspiration step has started. In response to these communications, the centrifuge microcontroller 1008 instructs the rotor and motor assembly 414 of the centrifuge assembly 400 to start rotating or turning at an even higher revolutions per minute (RPM, e.g., generally 5000 RPM) to start separating the red blood cells 1708 from the plasma 1704, as Figure 17KAs shown. The aspiration pump 208 continues to push the plasma 1704 through the flexible loop 524, the system static loop connection 528, and into the loop outlet tube 112. The aspiration process 1420 continues until at some point, such as Figure 17L As shown, the platelets 1710 separated from the whole blood 1706 reach the line sensor 812. The line sensor 812 signals the cassette microcontroller 1004 indicating that the total amount of plasma 1704 from the whole blood 1706 in the blood component collection bladder 536 has been aspirated, and the cassette microcontroller 1004 proceeds to step 1424. During this step, the status of the components of the apheresis system 200 can be as shown below:

[0259]

[0260] Table 10: Aspiration Status

[0261] When the platelets 1710, red blood cells, high hematocrit blood, and / or other blood components reach the line sensor 812 (determined by the sensor 812 observing a change in the color or other characteristics of the fluid), then in step 1426, the cassette microcontroller 1004 determines whether the blood donation is complete. Completing the blood donation means that all of the desired or expected plasma 1704 has been aspirated and placed into the plasma collection bottle 122. In an embodiment, the cassette microcontroller 1004 can determine whether a full blood donation (e.g., 880 mL) has been extracted. This can be as Figure 17L As shown, where the plasma 1704 has been extracted and remains in the loop outlet tube 112 and is provided to the plasma collection bottle 122 through the plasma tube 120. If the blood donation is not complete (meaning the plasma collection bottle 122 has not reached its desired weight or volume limit), the process 1400 can go to "No" for a return to step 1428. If the blood donation is complete, the method 1400 can go to "Yes" for a final return to step 1432.

[0262] In the return step 1428, as Figure 17L As shown, the cassette microcontroller 1004 instructs the aspiration pump 208 to stop and reverse the direction of the return pump 212, operating in a counterclockwise motion, thereby pushing the plasma 1704 from the plasma collection bottle 122 through the plasma tube 120 into the loop outlet tube 112 and towards the soft cassette 340. The cassette microcontroller 1004 further instructs the aspiration fluid control valve 320C to close and opens 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 out of the loop outlet tube 112, the flexible loop 524, the blood component collection bladder 536, flow through the drip chamber 354, and reach the blood donor 102. Importantly, as Figure 17LAs shown, during return step 1428, the filler 460 continues to rotate at an extraction speed (e.g., 5000 RPM). System 200 continues to push the red blood cells 1708 back into the donor 102 until the color / pressure sensor 808 determines that the plasma 1704 has flowed past the sensor 808 and may have reached the drip chamber 354, as Figure 17M shown. At this point, valves 320B and 320A close again, and the whole blood 1706 can flow through the first bypass branch 358A, the second bypass branch 358B, and / or the fluid sensor 316 again. During step 1428, the states of the components of the apheresis system 200 can be as shown below:

[0263]

[0264]

[0265] Table 11: Return Status

[0266] Then, return step 1428 proceeds to the second extraction step 1420. The new extraction is performed in a manner similar to step 1420 described above. However, a portion of the high hematocrit blood remains in the drip chamber 354. By flowing the new whole blood 1706 through the first bypass branch 358A, the second bypass branch 358B, and / or the fluid sensor 316, the lower high hematocrit blood returns to the blood component collection bladder 536, where the red blood cells will not have more plasma 1704 extracted from them. Thus, the bypass provided by the soft cassette 340 makes the removal of plasma 1704 from the whole blood 1706 more efficient during the second extraction step 1420 and subsequent extraction steps.

[0267] Return step 1428 and the continued extraction step 1420 will cycle multiple times. The final extraction step 1420 can be as Figure 17N shown. As Figure 17N shown, the plasma 1704 in the plasma collection bottle 122 has reached the desired amount and / or the maximum amount, e.g., 880 mL. At this point, in step 1432, a final return is required. During this return step, the states of the various components of the apheresis system 200 can be as shown below:

[0268]

[0269]

[0270] Table 12: Final Return Status

[0271] In step 1432, the total amount of plasma 1704 extracted 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 components back into donor 102. The cassette microcontroller 1004 can instruct the plasma flow control valve 286 to close to hold the donor plasma in the plasma collection bottle 122. The return pump 212 can continue to rotate counterclockwise to push the red blood cells 1708 and any plasma 1704 or other blood components back into donor 102.

[0272] In step 1436, as Figure 17O shown, after the final return 1432 or as part of the final return 1432, normal saline 1712 can also be returned to donor 102. In step 1436, the cassette microcontroller 1004 opens the normal saline flow control valve 288 and keeps the first fluid control valve 320A and the second fluid control valve 320A open. The return pump 212 continues to run counterclockwise. The centrifuge microcontroller 1008 causes the filler 460 to stop rotating. The normal saline 1712 from the normal saline bag 118 flows through the blood component collection bladder 536, the drip chamber 354, and different tubes and is pushed back into donor 102. The different blood components remaining in the blood component collection device 500 are pushed back into donor 102 together with a certain amount of normal saline 1712. The normal saline 1712 helps to replenish the fluid for donor 102 and is necessary in some jurisdictions. The normal saline 1712 continues to be returned until a predetermined amount of normal saline 1712 is provided to the user, and the predetermined amount of normal saline 1712 is determined by the weight or amount of the normal saline 1712 leaving the normal saline bag 118. At this time, as Figure 17O shown, the plasma donation is completed. During this step, the status of the components of the apheresis system 200 can be as follows:

[0273]

[0274]

[0275] Table 13: Normal Saline Return Status

[0276] According to an embodiment of the present disclosure, an embodiment of the method for unloading the plasma and the blood component collection device 500 from the apheresis system 200 described in the unloading phase 1216 can be as Figure 15 shown. The general order of the steps of the method 1500 is as Figure 15 shown. Generally, the method 1500 starts with the start operation 1504 and ends with the operation 1528. The method 1500 can include more or fewer steps, or can be different from Figure 15The sequential arrangement steps shown. Method 1500 can be performed at least in part by a set of computer-executable instructions executed by a computer system, a processor, the cartridge microcontroller 1004, the centrifuge microcontroller 1104, and / or other devices, and is encoded or stored on a computer-readable medium. In other configurations, method 1500 can be performed at least in part by a series of components, circuits, gates, etc. created in hardware devices such as SOCs, ASICs, and / or FPGAs. Hereinafter, method 1500 will be explained with reference to the systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signaling processes, models, environments, apheresis systems, methods, etc. described in conjunction with Figures 1 - 14 The systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signaling processes, models, environments, apheresis systems, methods, etc. will be used to explain method 1500.

[0277] In step 1508, the channel is evacuated. In an embodiment, the cartridge microcontroller 1004 causes the suction pump 208 to operate in a counterclockwise direction to continue to cause the physiological saline 1712 to flow out of the blood component collection bladder 536 and the rest of the blood component collection device 500 substantially completely, as Figure 17P shown. At a certain point, a substantial total amount of blood components and / or physiological saline 1712 is pushed back into the donor 102, in which case all the pumps 216, 208, and 212 stop running. Then, the fluid control valves 320A, the first fluid control valve 320A, the physiological saline flow control valve 288, and any other valves can be closed by the cartridge microcontroller 1004. At this time, only a small amount of physiological saline 1712 or no physiological saline should remain in the blood component collection device 500. The state of the apheresis system 200 can be as Figure 17Q shown. During this step, the states of the components of the apheresis system 200 can be as follows:

[0278]

[0279]

[0280] Table 14: Channel evacuation state

[0281] At this time, in step 1512, the blood component collection device 500 can be sealed, as Figure 17R shown. Sealing the blood component collection device 500 can include clamping the donor supply tube 104 leading to the donor 102 and fusing and sealing the tube at different positions. The sealing can be fusing the tube because the tube can be thermoplastic, as Figure 17RAs shown. For example, the anticoagulant tube 110, the physiological saline tube 116, the plasma tube 120 (above the plasma flow control valve 286), and the donor supply tube 104 are all heat-sealed to separate the AC bag 114, the plasma collection bottle 122, the physiological saline bag 118, and the donor 102 from the rest of the blood component collection device 500. During this step, the status of the components of the apheresis system 200 can be as follows:

[0282]

[0283]

[0284] Table 15: Status of the Sealing Kit

[0285] At this time, in step 1516, the needle can be withdrawn from the donor 102, as Figure 17R shown. During this step, the status of the components of the apheresis system 200 can be as follows:

[0286]

[0287] Table 16: Status of Needle Withdrawal from the Donor

[0288] In step 1520, the blood component collection device 500 can be unloaded from the apheresis system 200, which requires reversing at least some of the processes described in Figure 13 and Figure 16 During this step, the status of the components of the apheresis system 200 can be as follows:

[0289]

[0290]

[0291] Table 17: Unloading Status

[0292] Once unloaded, the used blood component collection device 500 can be disposed of as medical waste. As Figure 17S shown, the plasma collection bottle 122 can be sealed onto the plasma tube 120. Then, the sealed area can prevent any liquid from leaking out of the plasma collection bottle 122, the physiological saline bag 118, or the anticoagulant bag 114. Then, the plasma collection bottle 122 can be removed and used in any procedure that requires plasma. As Figure 17T shown, in step 1524, the remaining items can be discarded as medical waste, and the procedure is completed. At the end of the procedure, the status of the components of the apheresis system 200 can be as follows:

[0293]

[0294] Table 18: Completion Program Status

[0295] According to an embodiment of the present disclosure, an embodiment of method 1600 for inserting a disposable article into a filler of apheresis system 200 may be as Figure 16 shown. The general order of the steps of method 1600 is as Figure 16 shown. Generally, method 1600 starts with start operation 1604 and ends with operation 1632. Method 1600 may include more or fewer steps, or the steps may be arranged in an order different from Figure 16 shown. Method 1600 may be performed at least in part by a set of computer-executable instructions executed by a computer system, a processor, cassette microcontroller 1004, centrifuge microcontroller 1104, and / or other devices, and is encoded or stored on a computer-readable medium. In other configurations, method 1600 may be performed at least in part by a series of components, circuits, gates, etc. created in hardware devices such as SOC, ASIC, and / or FPGA. Hereinafter, method 1600 will be explained with reference to the systems, devices, valves, pumps, sensors, components, circuits, modules, software, data structures, signaling processes, models, environments, apheresis systems, methods, etc. described in conjunction with Figures 1 to 15 this

[0296] In step 1608, a filler 460 of apheresis system 200 may be provided. Filler 460 may be a component of apheresis system 200 and is configured to receive at least a portion of blood component collection device 500. In an embodiment, filler 460 is mounted on split housing pivot axis 406, which pivots to expose the interior of upper housing 404B (including filler filler 460). A user may pivot upper housing 404B to expose collection insertion channel 466, or in some embodiments, filler 460 may be automatically pivoted by a motor or other mechanical means. Such pivoting and / or loading may be as described in conjunction with the above Figures 4D to 4F and / or Figures 6A to 6C this

[0297] In step 1612, a blood component collection device 500 including a blood component collection bladder 536 may be provided. Blood component collection device 500 may be prepackaged and extractable from the package. A user may expose blood component collection bladder 536 to insert it into collection insertion channel 466, including ensuring that the free end 540B of the bladder is located at the passageway protrusion 476 of collection insertion channel 466 and that filler ring connector 532 is located at ring connection area 454. In the case where blood component collection bladder 536 is rigidly positioned, in step 1616, the user may shape blood component collection bladder 536 generally to the shape of collection insertion channel 466 and passageway protrusion 476, as Figures 5F to 5HAs shown. Thus, the user can form the blood component collection bladder 536 to be generally circular or any other shape that generally matches the shape of the collection insertion channel 466.

[0298] Then, in step 1620, the user can insert the formed blood component collection bladder 536 into the collection insertion channel 466 of the filler 460, as Figure 5G and Figure 5H shown, where the bladder free end 540B of the blood component collection bladder 536 is inserted into the passageway protrusion 476 of the collection insertion channel 466. The user can insert the blood component collection bladder 536 into the collection insertion channel 466 that is generally located at the central position within the filler insertion chamber 492. The centrifugal force will generally automatically align the blood component collection bladder 536 to the correct position within the filler insertion chamber 492. However, if not positioned where the centrifugal force can act on the blood component collection bladder 536, the blood component collection bladder 536 can pop out of the collection insertion channel 466. Once positioned, the blood component collection bladder 536 can be fixed in place.

[0299] In step 1624, the user can connect the filler ring connector 532 of the blood component collection bladder 536 to the ring connection area 454 of the collection insertion channel 466. The user can achieve the mechanical connection by snapping the filler ring connector 532 into the ring connection area 454. Then, the size and physical characteristics of the filler insertion chamber 492 can hold the blood component collection bladder 536 in a stable position where the filler ring connector 532 is stabilized in the ring connection area 454, thereby allowing the blood component collection bladder 536 to move to the center of the filler insertion chamber 492 during the operation of the centrifuge 400. The flexible ring 524 of the portion remaining outside or on the outside of the filler 460 can be mounted onto the ring capture arm 416. This mounting of the flexible ring 524 allows the centrifuge 400 to perform 1ω / 2ω operations.

[0300] In step 1628, after the flexible ring 524 is installed, the upper housing 404B can be flipped into place. Thus, the filler 460 can pivot about the hinge axis 406 (such as a hinge, etc.) into the interior of the system housing 204. Then, the centrifuge housing 404 can rotate with the blood component collection ring 520 passing through the ring into the gap 436 within the centrifugal split housing 404. When the blood component collection ring 520 is loaded at the ring loading position 520A, a portion of the blood component collection ring 520 can be partially received, held, and / or supported by the ring receiving bracket 426, as described in connection with Figures 4A to 4C stated. The access panel 224 can pivot to the closed position, thereby allowing the operation of the system 200.

[0301] Exemplary systems and methods of the present disclosure have been described in connection with apheresis methods and systems. However, to avoid unnecessarily obscuring the present disclosure, many known structures and devices have been omitted from the foregoing description. Such omissions should not be construed as a limitation on the scope of the claimed disclosure. Specific details are set forth to provide an understanding of the present disclosure. It should be understood, however, that the present disclosure may be implemented in many ways in addition to the specific details set forth herein.

[0302] In addition, although the exemplary aspects, embodiments, and / or configurations shown herein illustrate the components of the configured system, certain components of the system may be located in remote, distributed networks (such as LANs and / or the Internet), or within a dedicated system. Accordingly, it should be understood that the components of the system may be combined into one or more devices (such as cartridge node 904 and centrifuge node 908), or configured on particular nodes of a distributed network (such as an analog and / or digital telecommunications network, a packet-switched network, or a circuit-switched network). From the foregoing description, it can be understood that, for reasons of computational efficiency, the components of the system may be arranged anywhere in a distributed network of components without affecting the operation of the system. For example, the components may be located in switches (such as PBXs and media servers, gateways, one or more communication devices, in the homes of one or more users, or some combination thereof). Similarly, one or more functional portions of the system may be distributed between telecommunications devices and associated computing devices.

[0303] In addition, it should be understood that the different links connecting these elements may be wired or wireless links, or any combination thereof, or any other known or later-developed element capable of providing data to and / or transmitting data from the connected elements. These wired or wireless links may also be secure links and capable of transmitting encrypted information. For example, the transmission medium used as a link may be any suitable carrier of electrical signals, including coaxial cables, copper wires, and optical fibers, and may take the form of acoustic or optical waves, such as those generated during radio wave and infrared data communications.

[0304] In addition, although the flowcharts have been discussed and shown in connection with a particular order of events, it should be understood that the order may be changed, added to, and omitted without substantially affecting the operation of the disclosed embodiments, configurations, and aspects.

[0305] Many variations and modifications of the present disclosure may be used. It is possible to provide some features of the present disclosure without providing other features.

[0306] In yet another embodiment, the systems and methods of the present disclosure can be implemented in conjunction with a dedicated computer, a programmed microprocessor or microcontroller and peripheral integrated circuit elements, an application specific integrated circuit or other integrated circuit, a digital signal processor, hard-wired electronic or logic circuits such as discrete element circuits, programmable logic devices or gate arrays such as PLD, PLA, FPGA, PAL, a dedicated computer, any similar device, etc. Generally, any device or apparatus capable of implementing the methods shown herein can be used to implement various aspects of the present disclosure. Exemplary hardware that can be used for the disclosed embodiments, configurations, and aspects includes computers, handheld devices, telephones (e.g., cellular, Internet-enabled, digital, analog, hybrid, etc.), and other hardware known in the art. Some of these devices include processors (e.g., single or multiple microprocessors), memory, non-volatile memory, input devices, and output devices. Additionally, alternative software implementations including, but not limited to, distributed processing or component / object distributed processing, parallel processing, or virtual machine processing can also be constructed to implement the methods described herein.

[0307] In yet another embodiment, the disclosed method can be readily implemented in conjunction with software using an object or object-oriented software development environment that provides portable source code that can be used on various computer or workstation platforms. Alternatively, the disclosed system can be implemented in part or in whole in hardware using standard logic circuits or VLSI designs. Whether software or hardware is used to implement the system according to the present disclosure depends on the speed and / or efficiency requirements of the system, the particular functions, and the particular software or hardware system or microprocessor or microcomputer system used.

[0308] In yet another embodiment, the disclosed method can be implemented in part with software that can be stored on a storage medium and executed on a programmed general-purpose computer in cooperation with a controller and memory, a dedicated computer, a microprocessor, etc. In these cases, the systems and methods of the present disclosure can be implemented as a program embedded in a personal computer, such as an applet, JAVA or CGI script, as a resource resident on a server or computer workstation, as a routine embedded in a dedicated measurement system, system component, etc. The system can also be implemented by physically integrating the system and / or method into a software and / or hardware system.

[0309] Although the present disclosure describes components and functions implemented in various aspects, embodiments, and / or configurations with reference to specific standards and protocols, these aspects, embodiments, and / or configurations are not limited to these standards and protocols. Other similar standards and protocols that are not mentioned herein exist and are considered to be included in the present disclosure. In addition, the standards and protocols mentioned herein and other similar standards and protocols not mentioned herein are periodically replaced by faster or more efficient equivalents having substantially the same functions. Such replacement standards and protocols with the same functions are considered to be equivalents included in the present disclosure.

[0310] In various aspects, embodiments, and / or configurations, the present disclosure includes components, methods, processes, systems, and / or devices substantially as depicted and described herein, including various aspects, embodiments, configuration embodiments, sub-combinations, and / or subsets thereof. After understanding the present disclosure, those skilled in the art will understand how to manufacture and use the disclosed aspects, embodiments, and / or configurations. In different aspects, embodiments, and / or configurations, the present disclosure includes providing devices and methods in the absence of items not depicted and / or described herein or in the context of different aspects, embodiments, and / or configurations herein (including in the absence of items that may have been used in a previous device or process (e.g., for improving performance, achieving ease of use, and / or reducing implementation costs)).

[0311] The foregoing discussion has been presented for purposes of illustration and description. The foregoing is not intended to limit the present disclosure to one or more forms disclosed herein. For example, in the foregoing detailed description, various features of the present disclosure are combined in one or more aspects, embodiments, and / or configurations to simplify the present disclosure. The features of the aspects, embodiments, and / or configurations of the present disclosure may be combined in alternative aspects, embodiments, and / or configurations other than those discussed above. This disclosure method should not be construed as reflecting an intention that the claims require more features than are expressly recited in each claim. Instead, as reflected in the following claims, the inventive aspects lie in less than all of the features of a single foregoing disclosed aspect, embodiment, and / or configuration. Accordingly, the following claims are incorporated into this detailed description, with each claim standing on its own as a separate preferred embodiment of the present disclosure.

[0312] In addition, although the description has included a description of one or more aspects, embodiments, and / or configurations, as well as certain variations and modifications, after understanding the present disclosure, other variations, combinations, and modifications are also within the scope of the present disclosure, for example, within the skills and knowledge of those skilled in the art. It is intended to obtain rights to include alternative aspects, embodiments, and / or configurations (including alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps as claimed) within the permitted scope, regardless of whether such alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps are disclosed herein, and it is not intended to disclose any patentable subject matter.

Claims

1. A method for automatically loading a fluid line loop for automatically loading the fluid line loop into a centrifuge assembly, the method comprising: Attaching the fluid line loop to a fluid separator of the centrifuge assembly at a first end; And Rotating the fluid separator relative to a housing of the centrifuge assembly in a first rotational direction, wherein rotating the fluid separator causes the fluid line loop to rotate relative to the housing and be guided into a channel of a loop arm attached to a portion of the housing, wherein the channel includes a bearing disposed in a bearing set attached to the loop arm, and wherein when the centrifuge assembly rotates, the bearing holds the fluid line loop in a position relative to the housing.

2. The method according to claim 1, wherein When the fluid line loop rotates in a position relative to the housing within the channel, the bearing contacts a portion of the fluid line loop.

3. The method according to claim 1, wherein The housing of the centrifuge assembly rotates about a rotation axis in the first rotational direction at a first angular velocity, and the fluid separator is caused to rotate about the rotation axis at a different second angular velocity by a torsional force provided by the fluid line loop.

4. The method according to claim 3, wherein The second angular velocity is substantially twice the first angular velocity.

5. The method according to claim 1, wherein The fluid line loop is physically and fluidly attached to a disposable fluid separation bladder, the disposable fluid separation bladder being at least partially disposed within the fluid separator.

6. The method according to any one of claims 1 to 5, further comprising: Connecting a second end of the fluid line loop to a rotation fixed point of a apheresis machine; And Rotating the centrifuge assembly relative to the rotation fixed point of the apheresis machine about the rotation axis by a rotor and a motor assembly of the apheresis machine.

7. A method for flowing fluid through a soft cassette, the method comprising: Providing a soft cassette, The soft cassette comprising: A first cassette port fluidly connected to a cassette inlet tube; A second cassette port fluidly connected to a loop inlet tube; A direct flow lumen fluidly connecting the first cassette port and the second cassette port; A drip chamber internally disposed within the direct flow lumen such that fluid flowing through the direct flow lumen flows through the drip chamber; and A fluid flow bypass path fluidly connected to the direct flow lumen both between the first cassette port and the drip chamber and adjacent the first cassette port, and between the second cassette port and the drip chamber and adjacent the second cassette port, such that fluid flowing through the fluid flow bypass path bypasses the drip chamber; When a first fluid containing a component is drawn from a source: Receiving the first fluid from the cassette inlet tube at the first cassette port fluidly connected to the cassette inlet tube; Moving the first fluid through the fluid flow bypass to the second cassette port; Preventing the first fluid from moving through the direct flow lumen; When returning the component of the first fluid to the source: Receiving the component from the loop inlet tube at the second cassette port fluidly connected to the loop inlet tube; Moving the component through the direct flow lumen and the drip chamber to the first cassette port; and Prevent the component from moving through the fluid flow bypass path.

8. The method according to claim 7, wherein When the first fluid is aspirated from the source in a subsequent draw, a portion of the first fluid that was previously delivered to the source through the direct flow lumen when the component was returned to the source is retained in the drip chamber when the first fluid again passes through the fluid flow bypass path.

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